As filed with the Securities and Exchange Commission on November 4, 2003 |
Registration No. 333-_______ |
|
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM S-1
REGISTRATION
STATEMENT
UNDER
THE SECURITIES
ACT OF 1933
GENTA INCORPORATED
(Exact Name
of Registrant as Specified in Its Charter)
Delaware | 2836 | 33-0326866 |
(State
or Other Jurisdiction of
Incorporation or Organization) |
(Primary
Standard Industrial
Classification Code Number) |
(I.R.S.
Employer
Identification Number) |
Two Connell
Drive
Berkeley
Heights, NJ 07922
(908) 286-9800
(Address,
Including Zip Code, and Telephone Number, Including Area Code, of Registrants
Principal Executive Offices)
William
P. Keane
Vice President,
Chief Financial Officer
and Corporate Secretary
Genta Incorporated
Two Connell
Drive
Berkeley
Heights, NJ 07922
(908) 286-9800
(Name, Address,
Including Zip Code, and Telephone Number, Including Area Code, of Agent
For Service)
Copy
to:
Richard
A. Drucker
Davis Polk
& Wardwell
450 Lexington
Avenue
New York,
New York 10017
(212) 450-4000
Approximate date of commencement of proposed sale to the public:
As soon as practicable after the effective date of this Registration Statement.
If any of the securities being registered on this form are to be offered
on a delayed or continuous basis pursuant to Rule 415 under the Securities
Act of 1933, check the following box. [X]
If this form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ] __________
If this form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering. [ ] __________
If this form is a post-effective amendment filed pursuant to Rule 462(d)
under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering. [ ] __________
If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box. [ ]
CALCULATION OF REGISTRATION FEE | ||||
|
||||
Title
Of Each Class
Of Securities To Be Registered |
Amount
To Be
Registered |
Proposed
Maximum
Offering Price Per Unit (1) |
Proposed
Maximum
Aggregate Offering Price (1) |
Amount
Of
Registration Fee |
|
||||
Common Stock, par value $0.001 per share | ||||
(including Preferred Stock Purchase Rights(2)) | 671,412 shares | $10.68 | $7,170,681 | $581 |
|
(1) | Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(c) under the Securities Act of 1933 based on the average of the high and low prices of the Common Stock on the Nasdaq National Market on October 30, 2003. |
(2) | Rights trade together with the Common Stock. The value attributable to the Rights, if any, is reflected in the market price of the Common Stock. |
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to Completion. Dated ,
671,412 Shares
Genta Incorporated
Common Stock
The selling stockholders
of Genta Incorporated listed on page 49 of this
prospectus are offering and selling a total of 671,412 shares of Genta common
stock under this prospectus. These shares were originally issued to the selling
stockholders in connection with Gentas recently completed acquisition of Salus
Therapeutics, Inc. Genta will not receive any of the proceeds from the sale
of the shares sold by these selling stockholders and is not offering any shares
for sale under this prospectus. See Plan of Distribution for a description
of sales of the shares by the selling stockholders.
Our common stock is
listed on the Nasdaq National Market under the symbol GNTA. On November 3,
2003, the reported closing price of our common stock was $10.08
per share.
See Risk Factors beginning on page 1 to read about certain factors you should consider before buying shares of the common stock.
Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
Prospectus dated , .
We were incorporated in Delaware in 1988. In 1997, our company underwent a recapitalization, and a new management team was put in place, including our current chief executive officer, in late 1999. Our principal executive offices are located at Two Connell Drive, Berkeley Heights, New Jersey 07922 and our telephone number is (908) 286-9800. Our website address is www.genta.com. The information contained on our website is not a part of this prospectus.
The terms Genta, the Company, we, us and our refer to Genta Incorporated.
Ganite is a trademark of Genta. In the United States Genasense is the property of Genta. Outside of the United States Genasense is the property of Aventis Pharmaceuticals Inc. Service marks, trademarks and trade names referred to in this prospectus are the property of their respective owners.
i
RISK FACTORS
You should carefully consider the following risks and all of the other
information set forth in this prospectus before deciding to invest in shares
of our common stock. The risks described below are not the only ones facing
our company. Additional risks not presently known to us or that we currently
deem immaterial may also impair our business operations.
If any of the following risks actually occurs, our business, financial
condition or results of operations would likely suffer. In such case, the
trading price of our common stock could decline due to any of these risks,
and you may lose all or part of your investment.
Risks Related to Our Business
We may be unsuccessful in our efforts to obtain FDA approval for and commercialize Genasense or our other pharmaceutical products. |
The commercialization of our pharmaceutical products involves a number of significant challenges. In particular, our ability to commercialize products, such as Ganite and Genasense, depends, in large part, on the success of our clinical development programs, our efforts to obtain regulatory approvals and our sales and marketing efforts directed at physicians, patients and third-party payors. A number of factors could affect these efforts, including:
| our ability to demonstrate clinically that our products are useful and safe in particular indications; |
| delays or refusals by regulatory authorities in granting marketing approvals; |
| our limited financial resources and sales and marketing experience relative to our competitors; |
| actual and perceived differences between our products and those of our competitors; |
| the availability and level of reimbursement for our products by third-party payors; |
| incidents of adverse reactions to our products; |
| side effects or misuse of our products and the unfavorable publicity that could result; and |
| the occurrence of manufacturing, supply or distribution disruptions. |
We cannot assure you that Genasense will receive U.S. Food and Drug Administration,
or FDA, approval in the time frame we expect or at all. We are currently
in the process of filing our first FDA new drug application, or NDA, for
Genasense as a treatment combined with chemotherapy for patients with advanced
malignant melanoma. We intend to file for priority designation when that
application is complete, which will increase the probability that the review
by the FDA is concluded within six months from the date of the completed
application. However, the FDA may decline to review the application by
issuing a refusal to file notice that would return the application to
Genta. If the application is accepted for review, we cannot assure you
that it will receive priority review, and this or other factors could significantly
prolong the review time and delay the time of commercialization. If the
application is reviewed, we cannot assure you that the review will conclude
that Genasense should be approved for marketing. If Genasense is not approved
by the FDA for melanoma, if the review time is substantially prolonged
or if the FDA requires further clinical studies prior to approval, we have
no short-term alternative for generating substantial revenue or income.
Genasense may not be approved because the FDA may find our efficacy and
safety data deficient or for other reasons. While we have completed enrollment
in Phase 3 trials for other indications (including multiple myeloma and
chronic lymphocytic leukemia, or CLL), preparation of NDAs for either or
both of these indications would entail significant delay relative to the
melanoma application, and there can be no assurance that either or both
of these applications would suffice for Genasense approval. Failure to
obtain approval or a substantial delay in
1
approval of
Genasense would have a material adverse effect on our results of operations
and financial condition.
Ultimately, our efforts may not prove to be as effective as those of our
competitors. In the United States and elsewhere, our products will face
significant competition. The principal conditions on which our product
development efforts are focused and some of the other disorders for which
we are conducting additional studies, are currently treated with several
drugs, many of which have been available for a number of years or are available
in inexpensive generic forms. Thus, even if we obtain regulatory approvals,
we will need to demonstrate to physicians, patients and third-party payors
that the cost of our products is reasonable and appropriate in light of
their safety and efficacy, the price of competing products and the relative
health care benefits to the patient. If we are unable to demonstrate that
the costs of our products are reasonable and appropriate in light of these
factors, we will likely be unsuccessful in commercializing our products.
We intend to be a direct marketer of some products in the United States. Currently we have a limited number of sales personnel. Our inability to build a sales force capable of marketing our pharmaceutical products will adversely affect our sales and limit the commercial success of our products.
We anticipate that we will incur additional losses and we may never be profitable. |
We have not been profitable. We have incurred substantial operating losses associated with ongoing research and development activities, pre-clinical testing, clinical trials, regulatory submissions and manufacturing activities. From the period since our inception to June 30, 2003, we have incurred a cumulative net loss of $286.2 million. We may never achieve revenue sufficient for us to attain profitability. Achieving profitability is unlikely before Genasense becomes an approved drug and we receive at least a full year of royalties from Aventis Pharmaceuticals Inc., or Aventis, on worldwide sales pursuant to the development and commercialization agreements which we have entered into with Aventis. For a further description of our agreements with Aventis, see BusinessSales and Marketing.
Our business will suffer if we fail to obtain timely funding. |
Our operations to date have required significant cash expenditures. Our
future capital requirements will depend on the results of our research
and development activities, pre-clinical studies and clinical trials, competitive
and technological advances, and regulatory activities of the FDA and other
regulatory authorities. Our credit line with Aventis terminates with respect
to new borrowings upon the earlier of December 31, 2004 or the first FDA
approval of Genasense (which triggers a milestone payment from Aventis),
and amounts borrowed under the credit line are due six months after termination.
In order to commercialize our products, we will need to raise additional
financing. We may obtain that financing through public and private offerings
of our securities, including debt or equity financing, or through collaborative
or other arrangements with research institutions and corporate partners.
We may not be able to obtain adequate funds for our operations from these
sources when needed or on acceptable terms. Future collaborations or similar
arrangements may require us to license valuable intellectual property to,
or to share substantial economic benefits with, our collaborators. If we
raise additional capital by issuing additional equity or securities convertible
into equity, our stockholders may experience dilution and our share price
may decline. Any debt financing may result in restrictions on our spending.
If we are unable to raise additional financing, we will need to do one or more of the following:
| delay, scale back or eliminate some or all of our research and product development programs; |
| license third parties to develop and commercialize products or technologies that we would otherwise seek to develop and commercialize ourselves; |
| attempt to sell our company; |
| cease operations; or |
| declare bankruptcy. |
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Our business depends heavily on a small number of products. |
We are currently marketing one product, Ganite, and we are actively seeking
FDA approval of Genasense for advanced malignant melanoma. We do not expect
to expand our marketed product portfolio significantly in the short term.
If Genasense is not approved, or is commercially unsuccessful, we do not
expect significant sales of other products to offset this loss of potential
revenue.
To diversify our product line in the long term, it will be important for us to identify suitable technologies and products for acquisition or licensing and development. If we are unable to identify suitable technologies and products, or if we are unable to acquire or license products we identify, we may be unable to diversify our product line and to generate long-term growth.
We may be unable to obtain or enforce patents, other proprietary rights and licenses to protect our business; we could become involved in litigation relating to our patents or licenses that could cause us to incur additional costs and delay or prevent our introduction of new drugs to market. |
Our success will depend to a large extent on our ability to:
| obtain U.S. and foreign patent or other proprietary protection for our technologies, products and processes; |
| preserve trade secrets; and |
| operate without infringing the patent and other proprietary rights of third parties. |
Legal standards relating to the validity of patents covering pharmaceutical
and biotechnological inventions and the scope of claims made under these
types of patents are still developing, and they involve complex legal and
factual questions. As a result, our ability to obtain and enforce patents
that protect our drugs is highly uncertain. If we are unable to obtain
and enforce patents and licenses to protect our drugs, our business, results
of operations and financial condition could be adversely affected.
We hold numerous U.S., foreign and international patents covering various
aspects of our technology, which include novel compositions of matter,
use, methods of large-scale synthesis and methods of controlling gene expression.
In the future, however, we may not be successful in obtaining additional
patents despite pending or future applications. Moreover, our current and
future patents may not be sufficiently broad to protect us against competitors
who use similar technology. Additionally, our patents, the patents of our
business partners and the patents for which we have obtained licensing
rights may be challenged, narrowed, invalidated or circumvented. Furthermore,
rights granted under our patents may not be broad enough to cover commercially
valuable drugs or processes and therefore may not provide us with any competitive
advantage with respect thereto.
The pharmaceutical and biotechnology industries have been greatly affected
by time-consuming and expensive litigation regarding patents and other
intellectual property rights. We may be required to commence, or may be
made a party to, litigation relating to the scope and validity of our intellectual
property rights or the intellectual property rights of others. Such litigation
could result in adverse decisions regarding the patentability of our inventions
and products, the enforceability, validity or scope of protection offered
by our patents or our infringement of patents held by others. Such decisions
could make us liable for substantial money damages, or could bar us from
the manufacture, sale or use of certain products. Moreover, an adverse
decision may also compel us to seek a license from a third party. The costs
of any license may be expensive, and we may not be able to enter into any
required licensing arrangement on terms acceptable to us.
The cost to us of any litigation or proceeding relating to patent or license
rights, even if resolved in our favor, could be substantial. Some of our
competitors may be able to sustain the costs of complex patent or licensing
litigation more effectively than we can because of their substantially
greater resources.
3
Uncertainties
resulting from the initiation and continuation of any patent or related
litigation could have a material adverse effect on our ability to compete
in the marketplace.
We also may be required to participate in interference proceedings declared
by the U.S. Patent and Trademark Office and in International Trade Commission
proceedings aimed at preventing the importation of drugs that would compete
unfairly with our drugs. These types of proceedings could cause us to incur
considerable costs.
The patent covering the use of Ganite for its approved indication will expire in 2005. Genta has filed and continues to file patent applications seeking intellectual property protection for Ganite. If these applications are unsuccessful, competition from generic drugs may adversely affect the profitability of Ganite.
Many of our products are in an early stage of development, and we may never receive regulatory approval for these products. |
Most of our resources have been dedicated to the research and development of potential antisense pharmaceutical products such as Genasense, based upon oligonucleotide technology. While we have demonstrated the activity of antisense oligonucleotide technology in model systems in vitro and in animals, among our products, Genasense is our only antisense product to have been tested in humans. Several of our other technologies that serve as a possible basis for pharmaceutical products are only in pre-clinical testing. Results obtained in pre-clinical studies or early clinical investigations are not necessarily indicative of results that will be obtained in extended human clinical trials. Our products may prove to have undesirable and unintended side effects or other characteristics that may prevent our obtaining FDA or foreign regulatory approval for any indication. In addition, it is possible that research and discoveries by others will render our oligonucleotide technology obsolete or noncompetitive.
Clinical trials are costly and time consuming and are subject to delays; our business would suffer if the development process relating to our products were subject to meaningful delays. |
Clinical trials are very costly and time-consuming. The length of time
required to complete a clinical study depends upon many factors, including
but not limited to the size of the patient population, the ability of patients
to get to the site of the clinical study, the criteria for determining
which patients are eligible to join the study and other issues. Delays
in patient enrollment and other unforeseen developments could delay completion
of a clinical study and increase its costs, which could also delay any
eventual commercial sale of the drug that is the subject of the clinical
trial.
Our commencement and rate of completion of clinical trials also may be delayed by many other factors, including the following:
| inability to obtain sufficient quantities of materials for use in clinical trials; |
| inability to adequately monitor patient progress after treatment; |
| unforeseen safety issues; |
| the failure of the products to perform well during clinical trials; and |
| government or regulatory delays. |
If we fail to obtain the necessary regulatory approvals, we cannot market and sell our products in the United States or in other countries. |
The FDA and comparable regulatory agencies in foreign countries impose
substantial pre-market approval requirements on the introduction of pharmaceutical
products. These requirements involve lengthy and detailed pre-clinical
and clinical testing and other costly and time-consuming procedures. Satisfaction
of these requirements typically takes several years or more depending upon
the type,
4
complexity and novelty of the product. While limited trials of some of our products have produced favorable results, we cannot apply for FDA approval to market any of our products under development until pre-clinical and clinical trials on the product are successfully completed. Several factors could prevent successful completion or cause significant delays of these trials, including an inability to enroll the required number of patients or failure to demonstrate adequately that the product is safe and effective for use in humans. If safety concerns develop, the FDA could stop our trials before completion. We may not market or sell any product for which we have not obtained regulatory approval. We cannot assure you that the FDA or other regulatory agencies will ever approve the use of our products that are under development. If the patient populations for which our products are approved are not sufficiently broad, or if approval is accompanied by unanticipated labeling restrictions, the commercial success of our products could be limited and our business, results of operations and financial condition could consequently be materially adversely affected.
If the third party manufacturers upon which we rely fail to produce our products in the volumes that we require on a timely basis, or to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the commercialization of, or be unable to meet demand for, our products and may lose potential revenues. |
We do not manufacture any of our products or product candidates and we
do not plan to develop any capacity to do so. We have contracted with third-party
manufacturers to manufacture Ganite and Genasense. The manufacture of pharmaceutical
products requires significant expertise and capital investment, including
the development of advanced manufacturing techniques and process controls.
Manufacturers of pharmaceutical products often encounter difficulties in
production, especially in scaling up initial production. These problems
include difficulties with production costs and yields, quality control
and assurance and shortages of qualified personnel, as well as compliance
with strictly enforced federal, state and foreign regulations. Our third-party
manufacturers may not perform as agreed or may terminate their agreements
with us.
In addition to product approval, any facility in which Genasense is manufactured
or tested for its ability to meet required specifications must be approved
by the FDA before it can manufacture Genasense. Failure of the facility
to be approved could delay the approval of Genasense.
We do not currently have alternate manufacturing plans in place. The number
of third-party manufacturers with the expertise, required regulatory approvals
and facilities to manufacture bulk drug substance on a commercial scale
is limited, and it would take a significant amount of time to arrange for
alternative manufacturers. If we need to change to other commercial manufacturers,
the FDA and comparable foreign regulators must approve these manufacturers
facilities and processes prior to our use, which would require new testing
and compliance inspections, and the new manufacturers would have to be
educated in or independently develop the processes necessary for the production
of our products.
Any of these factors could cause us to delay or suspend clinical trials, regulatory submissions, required approvals or commercialization of our products or product candidates, entail higher costs and result in our being unable to effectively commercialize our products. Furthermore, if our third-party manufacturers fail to deliver the required commercial quantities of bulk drug substance or finished product on a timely basis and at commercially reasonable prices, and we were unable to promptly find one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent volume and on a timely basis, we would likely be unable to meet demand for our products and we would lose potential revenues.
Even if we obtain regulatory approval, we will be subject to ongoing regulation, and any failure by us or our manufacturers to comply with such regulation could suspend or eliminate our ability to sell our products. |
Ganite, Genasense, if it obtains regulatory approval, and any other product
we may develop will be subject to ongoing regulatory oversight, primarily
by the FDA. Failure to comply with post-marketing
5
requirements, such as maintenance by us or by the manufacturers of our products of current Good Manufacturing Practices as required by the FDA, or safety surveillance of such products or lack of compliance with other regulations could result in suspension or limitation of approvals or other enforcement actions. Current Good Manufacturing Practices are FDA regulations that define the minimum standards that must be met by companies that manufacture pharmaceuticals and apply to all drugs for human use including those to be used in clinical trials as well as those produced for general sale after approval of an application by the FDA. These regulations define requirements for personnel, buildings and facilities, equipment, control of raw materials and packaging components, production and process controls, packaging and label controls, handling and distribution, laboratory controls and recordkeeping. Furthermore, the terms of any product candidate approval, including the labeling content and advertising restrictions, may be so restrictive that they could adversely affect the marketability of our product candidates. Any such failure to comply or the application of such restrictions could limit our ability to market our product candidates and may have a material adverse effect on our business, results of operations and financial condition. Such failures or restrictions may also prompt regulatory recalls of one or more of our products, which could have material and adverse effects on our business.
We rely on our contractual collaborative arrangements with research institutions and corporate partners for development and commercialization of our products. Our business could suffer if we are not able to enter into suitable arrangements or if our collaborative arrangements are not successful in developing and commercializing products. |
We have entered into collaborative relationships relating to the conduct
of clinical research and other research activities in order to augment
our internal research capabilities and to obtain access to specialized
knowledge and expertise. The loss of any of these collaborative relationships
could have a material adverse effect on our business. In addition, our
business strategy depends in part on our continued ability to develop and
maintain relationships with leading academic and research institutions
and with independent researchers. The competition for these relationships
is intense, and we can give no assurances that we will be able to develop
and maintain these relationships on acceptable terms.
We also seek strategic alliances with corporate partners, primarily pharmaceutical and biotechnology companies, to help us develop and commercialize drugs. Various problems can arise in strategic alliances. A partner responsible for conducting clinical trials and obtaining regulatory approval may fail to develop a marketable drug. A partner may decide to pursue an alternative strategy or focus its efforts on alliances or other arrangements with third parties. A partner that has been granted marketing rights for a certain drug within a geographic area may fail to market the drug successfully. Consequently, strategic alliances that we may enter into may not be scientifically or commercially successful. In this regard, Genta Jago Technologies B.V., a joint venture we entered into with SkyePharma PLC to develop oral controlled-release drugs, has not resulted in any commercial products, and we may seek to terminate our involvement in this joint venture. Moreover, we may be unable to negotiate advantageous strategic alliances in the future. Our failure to enter into strategic alliances, or the failure of a current or future strategic alliance to achieve its goals, could harm our efforts to develop and commercialize our drugs.
We are dependent on our collaborators and cannot be sure that our collaborators will perform as expected. Moreover, collaborations might produce conflicts that could delay or prevent the development or commercialization of our potential product candidates and negatively impact our business and financial condition. |
We have agreed to commercialize Genasense, if and when it is approved by
the FDA, jointly with Aventis. Aventis will sell the product and pay us
a royalty, and we and Aventis will cooperate on various aspects of commercialization.
We have entered into an agreement under which Avecia Biotechnology, Inc.,
or Avecia, will manufacture Genasense if and when it is approved. We cannot
control the resources that Aventis, Avecia or any future collaborator may
devote to our products. Any of our present or future collaborators may
not perform their obligations as expected. These collaborators may breach
or terminate their agreements with us, for instance upon changes in control
or management of the collaborator, or they may otherwise fail to conduct
their collaborative activities successfully and in a timely manner. Our
commercialization agreement with Aventis may be terminated by Aventis with
six months
6
prior notice.
In addition, our collaborators may elect not to develop products arising
out of our collaborative arrangements or to devote sufficient resources
to the development, regulatory approval, manufacture, marketing or sale
of these products. If any of these events occur, we may not be able to
develop our products or commercialize our products.
An important part of our strategy involves conducting multiple product development programs. We may pursue opportunities in fields that conflict with those of our collaborators. In addition, disagreements with our collaborators could develop over rights to our intellectual property. The resolution of such conflicts and disagreements may require us to relinquish rights to our intellectual property that we believe we are entitled to. In addition, any disagreement or conflict with our collaborators could reduce our ability to obtain future collaboration agreements and negatively impact our relationship with existing collaborators. Such a conflict or disagreement could also lead to delays in collaborative research, development, regulatory approval or commercialization of various products or could require or result in litigation or arbitration, which would be time consuming and expensive and could have a significant negative impact on our business, financial condition and results of operations.
We may incur a variety of costs to engage in future acquisitions of companies, products or technologies, and the anticipated benefits of those acquisitions may never be realized. |
As a part of our business strategy, we may make acquisitions of, or significant investments in, complementary companies, products or technologies, although no significant acquisition or investments are currently pending. Any future acquisitions would be accompanied by risks such as:
| difficulties in assimilating the operations and personnel of acquired companies; |
| diversion of our managements attention from ongoing business concerns; |
| our potential inability to maximize our financial and strategic position through the successful incorporation of acquired technology and rights into our products and services; |
| additional expense associated with amortization of acquired assets; |
| maintenance of uniform standards, controls, procedures and policies; and |
| impairment of existing relationships with employees, suppliers and customers as a result of the integration of new management personnel. |
We cannot guarantee that we will be able to successfully integrate any business, products, technologies or personnel that we might acquire in the future, and our failure to do so could harm our business.
The raw materials for our products are produced by a limited number of suppliers, and our business could suffer if we cannot obtain needed quantities at acceptable price and quality. |
The raw materials that we require to manufacture our drugs, particularly oligonucleotides, are available from only a few suppliers. If these suppliers cease to provide us with the necessary raw materials or fail to provide us with adequate supply of materials at an acceptable price and quality, we could be materially adversely affected.
We face substantial competition from other companies and research institutions that are developing similar products, and we may not be able to compete successfully. |
In many cases, our products under development will be competing with existing
therapies for market share. In addition, a number of companies are pursuing
the development of antisense technology and controlled-release formulation
technology and the development of pharmaceuticals utilizing such technologies.
We compete with fully integrated pharmaceutical companies that have more
substantial experience, financial and other resources and superior expertise
in research and development,
7
manufacturing,
testing, obtaining regulatory approvals, marketing and distribution. Smaller
companies may also prove to be significant competitors, particularly through
their collaborative arrangements with large pharmaceutical companies or
academic institutions. Furthermore, academic institutions, governmental
agencies and other public and private research organizations have conducted
and will continue to conduct research, seek patent protection and establish
arrangements for commercializing products. Such products may compete directly
with any products that may be offered by us.
Our competition will be determined in part by the potential indications
for which our products are developed and ultimately approved by regulatory
authorities. For certain of our potential products, an important factor
in competition may be the timing of market introduction of our or our competitors
products. Accordingly, the relative speed with which we can develop products,
complete the clinical trials and approval processes and supply commercial
quantities of the products to the market are expected to be important competitive
factors. We expect that competition among products approved for sale will
be based, among other things, on product efficacy, safety, reliability,
availability, price, patent position and sales, marketing and distribution
capabilities. The development by others of new treatment methods could
render our products under development non-competitive or obsolete.
Our competitive position also depends upon our ability to attract and retain qualified personnel, obtain patent protection or otherwise develop proprietary products or processes and secure sufficient capital resources for the often substantial period between technological conception and commercial sales. We cannot assure you that we will be successful in this regard.
If third-party payors do not provide coverage and reimbursement for use of our products, we may not be able to successfully commercialize our products. |
Our ability to commercialize drugs successfully will depend in part on the extent to which various third-party payors are willing to reimburse patients for the costs of our drugs and related treatments. These third-party payors include government authorities, private health insurers, and other organizations, such as health maintenance organizations. Third-party payors often challenge the prices charged for medical products and services. Accordingly, if less costly drugs are available, third-party payors may not authorize or may limit reimbursement for our drugs, even if they are safer or more effective than the alternatives. In addition, the federal government and private insurers have changed and continue to consider ways to change, the manner in which health care services are provided and paid for in the United States. In particular, these third-party payors are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for new therapeutic products. In the future, it is possible that the government may institute price controls and further limits on Medicare and Medicaid spending. These controls and limits could affect the payments we collect from sales of our products. Internationally, medical reimbursement systems vary significantly, with some countries requiring application for, and approval of, government or third-party reimbursement. In addition, some medical centers in foreign countries have fixed budgets, regardless of levels of patient care. Even if we succeed in bringing therapeutic products to market, uncertainties regarding future health care policy, legislation and regulation, as well as private market practices, could affect our ability to sell our products in quantities, or at prices that will enable us to achieve profitability.
The nature of the business activities or positions of our principal stockholders and present and future officers and directors may involve conflicts of interest. |
One of our principal stockholders is Paramount Capital Asset Management,
Inc. The sole stockholder and chairman of Paramount Capital Asset Management,
Inc. is also the chairman of Paramount Capital Inc. and of Paramount Capital
Investment LLC. These three companies, together with their affiliates,
are collectively referred to as the Paramount Companies. The Paramount
Companies beneficially own approximately 29% of our common stock when calculated
on a fully diluted basis, including beneficial ownership by Aries Select
I, LLC, Aries Select II, LLC, and Aries Select, Ltd., of which Paramount
Capital Asset Management, Inc. is the investment manager.
In the regular course of business, the Paramount Companies
8
evaluate and pursue investment opportunities in biomedical and pharmaceutical products, technologies and companies. Due to the ownership and control of the Paramount Companies and the Aries Funds, and their involvement with other companies in the life sciences area, some of our current or future officers and directors may from time to time serve as officers or directors of other biopharmaceutical or biotechnology companies. We cannot assure you that these other companies will not have interests in conflict with ours.
We are dependent on our key executives and scientists, and the loss of key personnel or the failure to attract additional qualified personnel could harm our business. |
Our business is highly dependent on our key executives and scientific staff. The loss of key personnel or the failure to recruit necessary additional or replacement personnel will likely impede the achievement of our development objectives. There is intense competition for qualified personnel in the pharmaceutical and biotechnology industries, and there can be no assurances that we will be able to attract and retain the qualified personnel necessary for the development of our business. We currently have an open search for a Senior Vice President, Research. If we are unable to fill this position or others that open, our business may be harmed.
Our business exposes us to potential product liability that may have a negative effect on our financial performance and our business generally. |
The administration of drugs to humans, whether in clinical trials or commercially,
exposes us to potential product and professional liability risks, which
are inherent in the testing, production, marketing and sale of human therapeutic
products. Product liability claims can be expensive to defend and may result
in large judgments or settlements against us, which could have a negative
effect on our financial performance and materially and adversely affect
our business. We maintain product liability insurance (subject to various
deductibles), but our insurance coverage may not be sufficient to cover
claims. Furthermore, we cannot be certain that we will always be able to
maintain or increase our insurance coverage at an affordable price. Even
if a product liability claim is not successful, the adverse publicity and
time and expense of defending such a claim may interfere with or adversely
affect our business and financial performance.
Risks Related to Our Common Stock
Concentration of ownership of our stock could delay or prevent a change of control. |
Our directors, executive officers and principal stockholders the Paramount
Companies and the Aries Funds and Garliston Limited, a subsidiary of Aventis,
beneficially own approximately 44% of our outstanding common stock and
preferred stock. As a result, these stockholders, if acting together, have
the ability to significantly influence the outcome of corporate actions
requiring stockholder approval. This concentration of ownership may have
the effect of delaying or preventing a change in control of Genta.
In addition, Garliston Limited has agreed not to participate in hostile takeover attempts and to vote its shares in ways that may have anti-takeover effects.
Provisions in our restated certificate of incorporation, bylaws, rights agreement and Delaware law may discourage a takeover and prevent our stockholders from receiving a premium for their shares. |
Provisions in our restated certificate of incorporation and bylaws and
our rights agreement may discourage third parties from seeking to obtain
control of us and, therefore, could prevent our stockholders from receiving
a premium for their shares. Our restated certificate of incorporation gives
our board of directors the power to issue shares of preferred stock without
approval of the holders of common stock. This preferred stock could have
voting rights, including voting rights that could be superior to that of
our common stock. The affirmative vote of 66-2/3% of our voting stock is
required to approve certain transactions and to take certain stockholder
actions, including the amendment of our certificate of
9
incorporation.
Our bylaws contains provisions that regulate how stockholders may present
proposals or nominate directors for election at annual meetings of stockholders.
In addition, we are subject to Section 203 of the Delaware General Corporation Law, which contains restrictions on stockholder action to acquire control of Genta.
We have not paid, and do not expect to pay in the future, dividends on our common stock. |
We have never paid cash dividends on our common stock and do not anticipate paying any such dividends in the foreseeable future. We currently intend to retain our earnings, if any, for the development of our business.
Our stock price is volatile. |
The market price of our common stock, like that of the common stock of many other biopharmaceutical companies, has been and likely will continue to be highly volatile. Factors that could have a significant impact on the future price of our common stock include but are not limited to:
| the results of pre-clinical studies and clinical trials by us or our competitors; |
| announcements of technological innovations or new therapeutic products by us or our competitors; |
| government regulation; |
| developments in patent or other proprietary rights by us or our respective competitors, including litigation; and |
| fluctuations in our operating results, and market conditions for biopharmaceutical stocks in general. |
As of October 15, 2003, we had 76,263,984 shares of common stock outstanding
and options, warrants, convertible preferred stock and convertible debt outstanding
exercisable for or convertible into 18,474,636 additional shares. Future sales of shares
of common stock by existing stockholders, holders of preferred stock who might
convert such preferred stock into common stock and option and warrant holders
who may exercise their options and warrants to purchase common stock also could
adversely affect the market price of the common stock. Moreover, the perception
that sales of substantial amounts of our common stock might occur could adversely
affect prevailing market prices.
If we cease doing business and liquidate our assets, we are required to distribute proceeds to holders of our preferred stock before we distribute proceeds to holders of our common stock. |
In the event of our dissolution or liquidation, holders of our common stock
will not receive any proceeds until holders of the outstanding shares of
our series A convertible preferred stock receive a liquidation preference
in the amount of $13.025 million.
10
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We have made statements under the captions Risk Factors, Managements
Discussion and Analysis of Financial Condition and Results of Operations,
Business and in other sections of this prospectus that are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934. We
intend that all forward-looking statements be subject to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. In
some cases, you can identify these statements by forward-looking words
such as may, might, will, should, expects, plans, anticipates,
believes, estimates, predicts, potential or continue, the negative
of these terms and other comparable terminology.
These forward-looking statements reflect our views as of the date they are made with respect to future events and financial performance, but are subject to many risks and uncertainties, which could cause actual results to differ materially from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results to differ materially from those contemplated by the forward-looking statements include, among others, those listed under the caption entitled Risk Factors and the following:
| FDA approval or failure to approve Genasense; |
| our ability to develop, manufacture and sell our products or to enter into collaborative arrangements with third parties to manufacture or sell our products; |
| the safety and efficacy of our products; |
| the commencement and completion of pre-clinical and clinical trials; |
| our ability to obtain necessary regulatory approvals; |
| our contractual collaborative arrangements; |
| the adequacy of our capital resources; |
| the ability to obtain sufficient financing to maintain our planned operations; |
| the possibility and effect of patent infringement claims; and |
| the impact of competitive products and market conditions. |
Although we believe the expectations reflected in the forward-looking statements
are reasonable, we cannot guarantee future results, level of activity,
performance or achievements. Moreover, neither we nor any other person
assumes responsibility for the accuracy and completeness of any of these
forward-looking statements. We are under no duty to update any of these
forward-looking statements after the date of this prospectus to conform
our prior statements to actual results or revised expectations.
11
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of common stock by
the selling stockholders. All sale proceeds will be received by the selling
stockholders.
12
PRICE RANGE OF COMMON STOCK
Our common stock is traded on the Nasdaq National Market under the symbol
GNTA.
The following table presents, for the periods indicated, the high and low closing sales prices for the common stock as reported by Nasdaq.
High
|
Low
|
|
2001 | ||
First Quarter | $ 8.844 | $ 5.063 |
Second Quarter | 10.120 | 5.070 |
Third Quarter | 12.770 | 7.900 |
Fourth Quarter | 17.700 | 9.900 |
2002 | ||
First Quarter | $18.250 | $10.880 |
Second Quarter | 17.740 | 6.291 |
Third Quarter | 8.699 | 6.150 |
Fourth Quarter | 11.500 | 6.140 |
2003 | ||
First Quarter | $ 8.730 | $ 5.820 |
Second Quarter | 14.500 | 6.600 |
Third Quarter | 16.360 | 11.670 |
Fourth Quarter (through November 3, 2003) | 12.400 | 10.080 |
On November 3, 2003, the reported closing sale price of our common stock on the Nasdaq National Market was $10.08 per share.
DIVIDEND POLICY
We have never declared or paid any cash dividends on our common stock,
and we do not anticipate paying dividends on our common stock in the foreseeable
future. We currently intend to retain our earnings, if any, for the development
of our business. See Managements Discussion and Analysis of Financial
Condition and Results of Operations and Note 1 to the consolidated financial
statements for the six months ended June 30, 2003.
13
CAPITALIZATION
The following table sets forth our cash position and capitalization as
of June 30, 2003.
This table should be read in conjunction with Managements Discussion and Analysis of Financial Condition and Results of Operations and the consolidated financial statements and notes thereto appearing elsewhere in this prospectus.
June 30, 2003 | |
|
|
(In thousands, except per share data) | |
Cash, cash equivalents and short-term investments | $ 97,189 |
|
|
Long-term debt | 35,000 |
Stockholders equity: | |
Series A Convertible Preferred Stock, $.001 par value, 600 shares authorized | - |
Common Stock, $.001 par value per share, 120,000 shares authorized | 75 |
Additional paid-in capital | 324,792 |
Accumulated deficit | (286,211) |
Deferred compensation | (409) |
Accumulated other comprehensive (loss) income | (19) |
Cost of treasury stock (444 shares) | (2,809) |
|
|
Total stockholders equity | 35,419 |
|
|
Total capitalization (1) | $ 70,419 |
|
(1) | Total capitalization consists of total debt and total stockholders equity. |
14
Selected Consolidated Financial Data
The following selected consolidated financial data should be read in conjunction
with our consolidated financial statements and related notes and Managements
Discussion and Analysis of Financial Condition and Results of Operations appearing
elsewhere in this prospectus. The consolidated financial data as of and for
the years ended December 31, 2002, 2001, 2000, 1999 and 1998 have been derived
from our consolidated financial statements, which have been audited by Deloitte
& Touche, LLP, independent auditors. The consolidated statement of operations
data for the periods ended June 30, 2003 and 2002, and the balance sheet data
as of June 30, 2003, are unaudited but include all adjustments, consisting only
of normal recurring adjustments, which are considered necessary for a fair presentation
of the data. The historical results are not necessarily indicative of results
to be expected for any future period.
Six
Months Ended
June 30, |
Years
Ended December 31,
|
||||||||||||||||||||||
(In thousands, except per share data) | 2003 | 2002 | 2002 | 2001 | 2000 | 1999 | 1998 | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||||||
Consolidated Statements of Operations Data: | |||||||||||||||||||||||
Revenues: | |||||||||||||||||||||||
License and royalties revenue | $ | 542 | $ | 219 | $ | 61 | $ | 146 | $ | 22 | $ | - | $ | - | |||||||||
Related party contract revenue | - | - | - | - | - | - | 55 | ||||||||||||||||
Collaborative research and development | - | - | - | - | - | - | 50 | ||||||||||||||||
Development funding | 2,087 | 696 | 3,498 | - | - | - | - | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||
2,629 | 915 | 3,559 | 146 | 22 | - | 105 | |||||||||||||||||
Costs and expenses: | |||||||||||||||||||||||
Research and development, net | 4,978 | 19,530 | 58,899 | 39,355 | 6,830 | 4,205 | 2,114 | ||||||||||||||||
General and administrative | 10,911 | 11,049 | 19,347 | 8,215 | 3,323 | 4,054 | 3,868 | ||||||||||||||||
Equity related compensation | 288 | 477 | 1,016 | 1,074 | 8,605 | 3,074 | 154 | ||||||||||||||||
Settlement with Promega Biosciences, Inc.(2) | - | - | - | 1,000 | - | - | - | ||||||||||||||||
LBC Settlement | - | - | - | - | - | - | 547 | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||
16,177 | 31,056 | 79,262 | 49,644 | 18,758 | 11,333 | 6,683 | |||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||
Loss from operations | (13,548 | ) | (30,141 | ) | (75,703 | ) | (49,498 | ) | (18,736 | ) | (11,333 | ) | (6,578 | ) | |||||||||
Equity in net income of joint venture | - | - | 33 | - | 502 | 2,448 | (132 | ) | |||||||||||||||
Net loss of liquidated foreign subsidiary | - | - | - | - | - | - | (98 | ) | |||||||||||||||
Other income, net | 527 | 445 | 1,326 | 2,785 | 5,783 | 23 | (38 | ) | |||||||||||||||
Income taxes | - | - | (184 | ) | - | - | - | - | |||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||
Loss from continuing operations | (13,021 | ) | (29,696 | ) | (74,528 | ) | (46,713 | ) | (12,451 | ) | (8,862 | ) | (6,846 | ) | |||||||||
Loss from discontinued operations | - | - | - | - | - | (189 | ) | (739 | ) | ||||||||||||||
Gain on sale of discontinued operations | - | - | - | - | - | 1,607 | - | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||
Net loss | (13,021 | ) | (29,696 | ) | (74,528 | ) | (46,713 | ) | (12,451 | ) | (7,444 | ) | (7,585 | ) |
15
Six
Months Ended
June 30, |
Years
Ended December 31,
|
||||||||||||||||||||||
(In thousands, except per share data) | 2003 | 2002 | 2002 | 2001 | 2000 | 1999 | 1998 | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||||||
Preferred stock dividends | - | - | - | - | (3,443 | ) | (10,085 | ) | (633 | ) | |||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||
Net loss applicable to common shares | $ | (13,021 | ) | $ | (29,696 | ) | $ | (74,528 | ) | $ | (46,713 | ) | $ | (15,894 | ) | $ | (17,529 | ) | $ | (8,218 | ) | ||
|
|
|
|
|
|
|
|||||||||||||||||
Continuing operations | - | - | $ | (1.05 | ) | $ | (0.84 | ) | $ | (0.41 | ) | $ | (1.07 | ) | $ | (1.06 | ) | ||||||
Discontinued operations | - | - | - | - | - | 0.08 | (0.11 | ) | |||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||
Net loss per share (3) | $ | (0.18 | ) | $ | (0.44 | ) | $ | (1.05 | ) | $ | (0.84 | ) | $ | (0.41 | ) | $ | (0.99 | ) | $ | (1.17 | ) | ||
|
|
|
|
|
|
|
|||||||||||||||||
Weighted average shares used in computing | |||||||||||||||||||||||
net loss per share | 74,338 | 67,862 | 70,656 | 55,829 | 38,659 | 17,784 | 7,000 | ||||||||||||||||
|
|
|
|
|
|
|
As
of
June 30, |
As
of December 31,
|
|||||||||||||||||||
Consolidated Balance Sheet Data (1): | 2003
|
2002
|
2001
|
2000
|
1999
|
1998
|
||||||||||||||
(unaudited) | ||||||||||||||||||||
Cash, cash equivalents and short-term investments | $ | 97,189 | $ | 113,716 | $ | 54,086 | $ | 50,199 | $ | 10,101 | $ | 2,458 | ||||||||
Working capital | 101,258 | 91,586 | 42,709 | 48,321 | 9,434 | 3,629 | ||||||||||||||
Total assets | 127,069 | 136,419 | 60,630 | 57,208 | 12,228 | 7,551 | ||||||||||||||
Notes payable and capital lease | ||||||||||||||||||||
obligations, less current portion | - | 46,703 | 48,310 | 53,567 | 10,206 | 2,959 |
(1) | Reflects discontinued operations and balance sheet data of JBL Scientifics, Inc. as of May 10, 1999. |
(2) | During the first quarter of 2001, we agreed to restructure our $1.2 million promissory note receivable from Promega, Inc. to provide for a $0.2 million non-interest bearing note due upon final resolution of certain environmental issues related to JBL Scientific, Inc. and forgive all accrued interest. The transaction resulted in a non-recurring charge of $1.0 million for the quarter ended March 31, 2001. We are awaiting final acceptance by the Environmental Protection Agency of our settlement offer before the remaining note receivable will be repaid by JBL. See Notes 5 and 19 to our consolidated financial statements for the fiscal year ended December 31, 2002. |
(3) | Computed on the basis of net loss per common share. Basic and diluted loss per common share are identical for all periods as potentially dilutive securities, including options, warrants and convertible preferred stock have been excluded in the calculation of the net loss per common share due to their anti-dilutive effect. |
16
MANAGEMENTS
DISCUSSION AND ANALYSIS
OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Overview
Since its inception in February 1988, Genta has devoted its principal efforts
toward drug discovery and research and development. Genta has been unprofitable
to date and expects to incur substantial operating losses due to continued
requirements for ongoing and planned research and development activities,
pre-clinical and clinical testing, manufacturing activities, regulatory
activities and establishment of a sales and marketing organization. From
our inception to June 30, 2003, we have incurred a cumulative net loss
of $286.2 million. We have experienced significant quarterly fluctuations
in operating results and we expect that these fluctuations in revenues,
expenses and losses will continue.
Gentas strategy is to build a product and technology portfolio primarily
focused on its cancer-related products.
Critical
Accounting Policies
Our significant accounting policies are more fully described in Note 2 to the consolidated financial statements for the fiscal year ended December 31, 2002. In preparing our financial statements in accordance with accounting principles generally accepted in the United States of America, management is required to make estimates and assumptions that, among other things, affect the reported amounts of assets and liabilities and reported amounts of revenues and expenses. These estimates are most significant in connection with our critical accounting policies, namely those of our accounting policies that are most important to the portrayal of our financial condition and results and require managements most difficult, subjective or complex judgments. These judgments often result from the need to make estimates about the effects of matters that are inherently uncertain. Actual results may differ from those estimates under different assumptions or conditions. We believe that our most critical accounting policies relate to:
| Revenue recognition. Our policy is to recognize revenues under license arrangements when delivery has occurred or services have been rendered, persuasive evidence of an arrangement exists, the fee is fixed and determinable, and collectibility is reasonably assured. Royalties are recognized when earned. Consistent with Staff Accounting Bulletin No. 101 Revenue Recognition, initial funding of ongoing development received from Aventis Pharmaceuticals Inc., or Aventis, after the achievement of certain research and development milestones will be recognized on a straight-line basis over the estimated useful life of the related first-to-expire patent of 115 months. See Note 12 to our consolidated financial statements for the fiscal year ended December 31, 2002. Any subsequent milestone payments that may be received from Aventis will also be recognized over the then-remaining estimated useful life of the related first-to-expire patent. |
| Research and development costs. All such costs are expensed as incurred, including raw material costs required to manufacture drugs for clinical trials. Once Genta has submitted a new drug application, or NDA, which includes the results of the pre-clinical and clinical testing, chemistry, manufacturing and control information, to the FDA for approval to commence commercial sales, Genta will then include the sales launch product, consisting of raw materials and all subsequent processing costs required to produce finished goods, as inventory on Gentas balance sheet in anticipation of approval by the FDA. Reimbursements for applicable Genasense related costs, under the collaborative agreement between Genta and Aventis, will continue to be recorded as a reduction to expense. See Note 12 to our consolidated financial statements for the fiscal year ended December 31, 2002. |
| Intangible assets. Our intangible assets consist primarily of licensed technology and capitalized patent costs, and are amortized using the straight-line method over their estimated useful lives. Our policy is to evaluate the appropriateness of the carrying values of the unamortized balances of intangible assets on the basis of estimated future cash flows (undiscounted) and other factors. |
17
If such evaluation were to indicate an impairment of these intangible assets, such impairment would be recognized by a write-down of the applicable assets. We evaluate the continuing value of patents and patent applications each financial reporting period. As a result of this evaluation, we may elect to continue to maintain, seek to out-license, or abandon these patents. |
Recent Accounting
Pronouncements
We have adopted all required Statements of Financial Accounting Standards issued subsequent to December 31, 2001. See Note 2 to our consolidated financial statements for the fiscal year ended December 31, 2002. Adoption of these standards did not or is not expected to have a material effect on our financial position or results of operations.
Recent Developments
On October 30, 2003, we announced financial results for the third quarter of 2003. In the third quarter of 2003, revenues totaled $1.3 million, unchanged from the corresponding 2002 period. The revenues consist primarily of amortization of payments made by Aventis pursuant to our collaboration agreements. Total third quarter gross operating expenses of $30.4 million, before the net Aventis expense reimbursement, increased by approximately $6.8 million relative to the comparable quarter in 2002. The 2003 increase in expenses was associated with the Genasense Phase 3 clinical trials and NDA preparation activities, and costs associated with the start-up of the Genta sales force and Ganite launch activities.
Pursuant to cost-sharing provisions of the Aventis collaboration to develop Genasense, we recorded $11.8 million of net expense reimbursement in the third quarter, which is recorded as a receivable at September 30, 2003. In the third quarter, operating expenses, net of Aventis reimbursement, increased from $16.9 million in 2002 to $18.6 million in 2003.
As a result of the factors described above, we reported a net loss of $17.2 million, or $(0.23) per share, for the quarter ended September 30, 2003, compared to a net loss of $15.1 million, or $(0.21) per share, for the third quarter of 2002. Our cash, cash equivalents and short-term investments totaled $87.4 million as of September 30, 2003, compared to $113.7 million at December 31, 2002 and $126.8 million at September 30, 2002.
Results of Operations
Three Months Ended June 30, 2003 and 2002 |
($ thousands) | Summary
Operating Results
For the Three Months Ended June 30, |
||||||||||
|
|||||||||||
Increase (Decrease) | |||||||||||
|
|||||||||||
2003 | $ | % | 2002 | ||||||||
|
|
|
|
||||||||
Revenues: | |||||||||||
Licensing fees and royalties | $ | 276 | $ | 62 | 29 | % | $ | 214 | |||
Development funding | 1,044 | 348 | 50 | % | 696 | ||||||
|
|
|
|
||||||||
1,320 | 410 | 45 | % | 910 | |||||||
Costs and expenses: | |||||||||||
Research and development | 18,111 | 1,669 | 10 | % | 16,442 | ||||||
General and administrative | 6,131 | (2,539 | ) | (29 | )% | 8,670 | |||||
Compensation expense | |||||||||||
related to stock options | 144 | (94 | ) | (39 | )% | 238 | |||||
Less: Expense | |||||||||||
reimbursement | 19,433 | 12,261 | 171 | % | 7,172 | ||||||
|
|
|
|
||||||||
4,953 | (13,225 | ) | (73 | )% | 18,178 | ||||||
|
|
|
|
||||||||
Loss from operations | (3,633 | ) | (13,635 | ) | (79 | )% | (17,268 | ) | |||
Other income, principally net | |||||||||||
interest income | 435 | 136 | 45 | % | 299 | ||||||
Less: Interest expense | 220 | 120 | 120 | % | 100 | ||||||
|
|
||||||||||
Net loss applicable to common | |||||||||||
shares | (3,418 | ) | $ | (13,651 | ) | (80 | )% | $ | (17,069 | ) | |
|
|
|
|
Revenues |
Licensing fees, development funding and royalties for the three months ended June 30, 2003 increased $0.410 million over the comparable period in 2002. This increase reflects the amortization, for three months in 2003 compared to two months in 2002, of the up-front licensing fee and development funding received from Aventis, which are being recognized over the estimated useful life of the first-to-expire related patent of 115 months. Royalties were $0.010 million and $0.036 million for the three months ended June 30, 2003 and 2002, respectively.
Research and Development Expenses |
Research and development expenses before reimbursement for the three months
ended June 30, 2003 increased $1.669 million or 10% over the comparable
period in 2002. The increase in research and development expenses is primarily
attributable to the costs of the Genasense Phase 3 clinical trials and
NDA preparation activities for Genasense, offset by the fact that we did
not purchase any drug
18
substances in the quarter. Of the $18.111 million in research and development expenses for the three months ended June 30, 2003, $14.523 million and $0.774 million were reimbursable at 75% and 100%, respectively, pursuant to our collaborative agreement with Aventis, of which the net amount of $11.666 million is expected to be reimbursed in the third quarter. We expect an additional $8.141 million to be reimbursed in the third quarter for drug substance and drug product shipped to Aventis in the second quarter in connection with drug substance purchases we expensed in 2002.
General and Administrative Expenses |
General and administrative expenses for the three months ended June 30, 2003 decreased $2.539 million or 29% over the comparable period in 2002. In 2002, higher expenses were a result of financial advisory services, royalty payments and legal fees relating to our collaborative agreement with Aventis. This was partially offset in 2003 by increased costs associated with Ganite pre-launch activities and general corporate expenses driven by business growth. There were no sales and marketing related expenses reimbursable at 100% pursuant to our collaborative agreement with Aventis for the three months ended June 30, 2003, as sales and marketing related expenses related to Genasense are mainly being billed to, and paid for, directly by Aventis.
Expense Reimbursement |
Expense reimbursement for the three months ended June 30, 2003 relate to various third-party, Full-time Equivalents, or FTE, and drug supply costs that Aventis is required to reimburse under our collaborative agreement with them, as follows ($ thousands):
Reimbursement to Genta: | |||
Third-party costs | $ | 8,822 | |
Drug supply costs | 9,192 | ||
FTEs | 1,793 | ||
|
|||
Amount due to Genta | 19,807 | ||
Reimbursement to Aventis: | |||
FTEs | (374 | ) | |
|
|||
Net amount due to Genta | $ | 19,433 | |
|
Other Income Less Interest Expense |
Net other income for the three months ended June 30, 2003 increased $0.016 million or 8% over the comparable period in 2002, principally as a result of higher investment balances on investments, offset by interest expense on the $10.0 million note issued by us to Aventis and the $25.0 million borrowed from Aventis under our credit line with them. See Notes 6 and 7 to our consolidated financial statements for the three and six months ended June 30, 2003.
Net Loss |
Genta incurred a net loss of $3.418 million, or $0.05 per share, for the
three months ended June 30, 2003, compared with a net loss of $17.069 million,
or $0.25 per share, for the three months ended June 30, 2002. The decrease
in net loss, and per share net loss to common shareholders, was primarily
due to the expense reimbursement received by us from Aventis pursuant to
our collaborative agreement with Aventis of $19.433 million or $0.26 per
share, offset by increased expenses primarily related to third-party costs
for current Genasense on-going clinical studies, expenses attributable
to the NDA preparation for Genasense, general corporate legal fees, personnel
costs and Ganite marketing-related spending.
19
Six Months Ended June 30, 2003 and 2002 |
Summary Operating Results For the Six Months Ended June 30, | |||||||||||
|
|||||||||||
Increase (Decrease) | |||||||||||
|
|||||||||||
($ thousands) | 2003 | $ | % | 2002 | |||||||
Revenues: |
|
|
|
|
|||||||
Licensing fees and royalties | $ | 542 | $ | 323 | 147 | % | $ | 219 | |||
Development funding | 2,087 | 1,391 | 200 | % | 696 | ||||||
|
|
|
|
||||||||
2,629 | 1,714 | 187 | % | 915 | |||||||
Costs and expenses: | |||||||||||
Research and development | 33,568 | 7,289 | 28 | % | 26,279 | ||||||
General and administrative | 10,911 | (561 | ) | (5 | )% | 11,472 | |||||
Compensation expense related to stock | |||||||||||
options | 288 | (189 | ) | (40 | )% | 477 | |||||
Less: Aventis reimbursement | 28,590 | 21,418 | 299 | % | 7,172 | ||||||
|
|
|
|
||||||||
16,177 | (14,879 | ) | (48 | )% | 31,056 | ||||||
|
|
|
|
||||||||
Loss from operations | (13,548 | ) | (16,593 | ) | (55 | )% | (30,141 | ) | |||
Other income, principally net interest income | 887 | 342 | 63 | % | 545 | ||||||
Less: Interest expense | 360 | 260 | 260 | % | 100 | ||||||
|
|
||||||||||
Net loss applicable to common shares | $ | (13,021 | ) | $ | (16,675 | ) | (56 | )% | $ | (29,696 | ) |
|
|
|
|
Revenues |
Licensing fees, development funding and royalties for the six months ended June 30, 2003 increased $1.714 million over the comparable period in 2002. This increase reflects the amortization for six months in 2003 compared to two months in 2002, of the up-front licensing fee and development funding received from Aventis, which are being recognized over the estimated 115 months of useful life of the first-to-expire related patent. See Note 5 to our consolidated financial statements for the six months ended June 30, 2003. Royalties were $0.010 million and $0.036 million for the six months ended June 30, 2003 and 2002, respectively.
Research and Development Expenses |
Research and development expenses before reimbursement for the six months ended June 30, 2003 increased $7.289 million or 28% over the comparable period in 2002. The increase in research and development expenses is primarily attributable to the costs of the Genasense Phase 3 clinical trials and NDA preparation activities for Genasense offset by the fact that we did not purchase any drug substances in the first six months of 2003. Of the $33.568 million in research and development expenses for the six months ended June 30, 2003, $25.584 million and $2.114 million were reimbursable at 75% and 100%, respectively, pursuant to our collaborative agreement with Aventis, of which the net amount of $21.302 million is expected to be reimbursed by Aventis. See Note 4 to our consolidated financial statements for the six months ended June 30, 2003. We expect an additional $8.141 million to be reimbursed for drug substances and products shipped to Aventis in the second quarter in connection with drug substance purchases we expensed in 2002.
General and Administrative Expenses |
General and administrative expenses for the six months ended June 30, 2003
decreased $0.561 million or 5% over the comparable period in 2002. The
decrease is primarily related to financial advisory services, royalty payments
and legal fees relating to our collaborative agreement with Aventis. This
was partially offset in 2003 by increased costs associated with Ganite
pre-launch activities and general corporate expenses driven by business
growth. There were no sales and marketing related expenses reimbursable
at 100% pursuant to our collaborative agreement with Aventis for the six
months ended
20
June 30, 2003, as sales and marketing related expenses related to Genasense are mainly being billed to, and paid for, directly by Aventis.
Expense Reimbursement |
Expense reimbursement for the six months ended June 30, 2003 relate to various third-party, FTE compensation and drug supply costs that Aventis is required to reimburse under our collaborative agreement with Aventis, as follows ($ thousands):
Reimbursement to Genta | |||
Third-party costs | $ | 14,870 | |
Drug supply costs | 11,240 | ||
FTEs | 3,333 | ||
|
|||
Amount due to Genta | 29,443 | ||
Reimbursement to Aventis: | |||
FTEs | (853 | ) | |
|
|||
Net reimbursement to Genta | $ | 28,590 | |
|
See Note 4 to our consolidated financial statements for the six months ended June 30, 2003.
Other Income Less Interest Expense |
Net other income for the six months ended June 30, 2003 increased $0.082 million or 18% over the comparable period in 2002, principally as a result of higher investment balances on investments, offset by interest expense on the $10.0 million convertible promissory note issued by us to Aventis and the $25.0 million borrowed from Aventis under our credit line with them. See Notes 6 and 7 to our consolidated financial statements for the six months ended June 30, 2003.
Net Loss |
Genta incurred a net loss of $13.021 million, or $0.18 per share, for the six months ended June 30, 2003, compared with a net loss of $29.696 million, or $0.44 per share, for the six months ended June 30, 2002. The decrease in net loss, and per share net loss to common shareholders, was primarily due to the expense reimbursement received by us from Aventis pursuant to our collaborative agreement with Aventis of $28.590 million or $0.38 per share, offset by increased expenses primarily related to third-party costs for current Genasense on-going clinical studies, expenses attributable to the NDA preparation for Genasense, general corporate legal fees, personnel costs and Ganite marketing-related spending.
Fiscal Years Ended December 31, 2002, 2001 and 2000 |
Summary Operating Results | |||||||||||||||
For the years ended December 31, | |||||||||||||||
|
|||||||||||||||
2002 | Increase
(Decrease) |
2001 | Increase
(Decrease) |
2000 | |||||||||||
|
|
|
|
|
|||||||||||
($ thousands) | |||||||||||||||
Revenues: | |||||||||||||||
License fees | $ | 3,498 | $ | 3,401 | $ | 97 | $ | 80 | $ | 17 | |||||
Royalties | 61 | 12 | 49 | 44 | 5 | ||||||||||
|
|
|
|
|
|||||||||||
3,559 | 3,413 | 146 | 124 | 22 | |||||||||||
Costs and expenses: | |||||||||||||||
Research and development | 58,899 | 19,544 | 39,355 | 32,525 | 6,830 | ||||||||||
General and administrative | 19,347 | 11,132 | 8,215 | 4,892 | 3,323 | ||||||||||
Settlement with Promega | |||||||||||||||
Biosciences, Inc. | - | (1,000 | ) | 1,000 | 1,000 | - |
21
Summary Operating Results | |||||||||||||||
For the years ended December 31, | |||||||||||||||
|
|||||||||||||||
2002 | Increase
(Decrease) |
2001 | Increase
(Decrease) |
2000 | |||||||||||
|
|
|
|
|
|||||||||||
($ thousands) | |||||||||||||||
Equity related compensation | 1,016 | (58) | 1,074 | (7,531) | 8,605 | ||||||||||
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|
|
|
|||||||||||
79,262 | 29,618 | 49,644 | 30,886 | 18,758 | |||||||||||
|
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|
|
|||||||||||
Loss from operations | (75,703 | ) | 26,205 | (49,498 | ) | 30,762 | (18,736 | ) | |||||||
Equity in net income of joint venture | 33 | 33 | - | (502 | ) | 502 | |||||||||
Other income | 1,326 | (1,459 | ) | 2,785 | (2,998 | ) | 5,783 | ||||||||
Income taxes | (184 | ) | (184 | ) | - | - | - | ||||||||
|
|
|
|
|
|||||||||||
Net loss | $ | (74,528 | ) | $ | 27,815 | $ | (46,713 | ) | $ | 34,262 | $ | (12,451 | ) | ||
|
|
|
|
|
Revenues |
Operating revenues consisting of license fees and royalties were $3.559 million in 2002 compared to $0.146 million in 2001 and $0.022 million in 2000. These revenues were derived mainly from the initial $10.0 million licensing fee and $40.0 million development funding received from Aventis under our collaborative agreement with Aventis, along with non-exclusive sub-license agreements involving antisense technology. See Note 12 to our consolidated financial statements for the fiscal year ended December 31, 2002. These initial payments received from Aventis will be recognized over the estimated useful life of the first-to-expire related patent of 115 months. The non-exclusive sub-license agreements were initiated with Atugen AG and EpiGenesis Pharmaceuticals, Inc. in 2001, and Sequitur, Inc. and Oasis Biopharmaceuticals, Inc. in 2000.
Costs and Expenses |
Costs and expenses totaled $79.3 million in 2002, net of Aventis reimbursement of $28.451 million, compared to $49.6 million in 2001 and $18.8 million in 2000. These increases reflect additional clinical trial activity and related drug supply costs and salaries. Services and capabilities that have not been retained within Genta are out-sourced through short-term contracts or consultants. Substantially all pre-clinical biology and clinical trial work are now conducted through such collaborations with external scientists and clinicians. We anticipate that, if sufficient collaborative revenues and other funding are available, research and development expenses may increase in future years due to requirements for pre-clinical studies, clinical trials and increased regulatory costs. We will continue to assess the potential cost benefit ratio of developing our own antisense oligonucleotide manufacturing and marketing and sales activities if and as such products are successfully developed and approved for marketing.
Research and Development Expenses |
Research and development expenses totaled $58.9 million in 2002, net of
Aventis reimbursement of $27.746 million, compared to $39.4 million in
2001 and $6.8 million in 2000. The increase from 2000 through 2002 is due
primarily to drug supply costs and investigator and monitor fees related
to expanded clinical trials. It is anticipated that research and development
expenses will continue to increase in the future, as Genta expands its
other product development programs. Furthermore, we are also pursuing other
opportunities for new product development candidates, which, if successful,
will require additional research and development expenses.
In an effort to focus our research and development on areas that provide
the most significant commercial opportunities, we continually evaluate
our ongoing programs in light of the latest market information and conditions,
availability of third-party funding, technological advances, and other
factors. As a result of such evaluation, our product development plans
have changed from time to time, and we anticipate that they will continue
to do so in the future.
22
General and Administrative Expenses |
General and administrative expenses were $19.4 million in 2002, net of
Aventis reimbursement of $0.705 million, compared to $8.2 million in 2001
and $3.3 million in 2000. The increase is primarily related to financial
advisory services, royalty payments and legal fees relating to our collaborative
agreement with Aventis, personnel costs and increased marketing-related
spending. We record charges to general and administrative expense for the
carrying value of abandoned patents no longer related to the research and
development efforts of Genta. There were no abandoned patent charges in
2002 and the amounts recorded in 2001 and 2000 were immaterial.
We recorded charges to non-cash equity related compensation of $1.0 million
in 2002 compared to $1.1 million in 2001 and $8.6 million in 2000. This
decrease in 2001 was primarily due to the acceleration of outstanding stock
options for the four members of our Board of Directors who resigned in
March 2000. See Note 18 to our consolidated financial statements for the
fiscal year ended December 31, 2002.
Equity in net income of joint venture (Genta Jago Technologies B.V.) was $0.033 million in 2002 compared to none in 2001 and $0.502 million in 2000. Since the first quarter of 2000, there have been only $0.033 million in net earnings of the joint venture allocated to Genta, and we may seek to terminate our involvement in the joint venture.
Other Income |
Net other income, principally interest income, decreased over the comparable
periods in 2001 and 2000 as a result of significantly lower investment
balances and decreased yields on investments. The proceeds received by
us from Aventis were not placed into any investment instruments until October
2002. Interest expense is attributable to interest being accrued on the
$10.0 million convertible promissory note issued by us to Aventis. Interest
income has fluctuated significantly each year and is anticipated to continue
to fluctuate primarily due to changes in the levels of cash, investments
and interest rates during each period.
We recorded no gain on the sale of marketable securities in 2002 compared
to approximately $0.061 million in 2001 and to $4.9 million in 2000, which
reflects a non-recurring gain on the disposition of securities in September
2000. We exercised 66,221 warrants to purchase shares of common stock of
CV Therapeutics, Inc. These warrants, which were restricted and not publicly
traded, were issued to us by CV Therapeutics, Inc. in connection with a
licensing arrangement entered into in 1993. We received approximately $4.9
million in cash upon the sale of such shares of common stock.
Liquidity
and Capital Resources
Since inception, we have financed our operations primarily through private
placements and public offerings of our equity securities. Cash provided
from these offerings totaled approximately $278.8 million through December
31, 2002, including net proceeds of $71.0 million received in 2002, $32.2
million received in 2001 and $40.1 million received in 2000. We used $19.7
million in operating activities during 2002, resulting from a net loss
of $74.5 million, offset by deferred revenues received from Aventis, non-cash
charges and improved working capital aggregating $54.8 million. At June
30, 2003, we had cash, cash equivalents and short-term investments totaling
$97.2 million compared to $113.7 million at December 31, 2002.
In March 2003, Genta and Aventis negotiated a line of credit for an amount
up to $40.0 million which terminates with respect to additional borrowings
on the earlier to occur of FDA approval of Genasense or December 31, 2004.
Loans under this line of credit are subject to repayment six months after
termination. As of June 30, 2003, $15.0 million remained available under
this line of credit. FDA approval of Genasense would trigger a milestone
payment from Aventis of $75.0 million. Management believes that at the
current rate of spending, primarily in support of on-going and anticipated
clinical trials, and after considering expense reimbursement and the line
of credit provided by Aventis, we should have sufficient cash funds to
maintain our present operations to the end of 2004.
23
Our principal expenditures relate to our research and development activities,
which include our on-going and future clinical trials. We expect these
expenditures to continue. We expect increased total expenditures, prior
to expense reimbursement, for clinical trials and drug supply related to
Genasense as a result of our collaboration agreements with Aventis. In addition,
expenditures associated with other products under development by us may
increase as research and development activities become more focused and
as other clinical trials are initiated.
If we successfully secure sufficient levels of collaborative revenues and
other sources of financing, we expect to use such financing to continue
to expand our ongoing research and development activities, pre-clinical
testing and clinical trials, costs associated with the market introduction
of potential products and expansion of our administrative activities.
We anticipate that significant additional sources of financing, primarily
expense reimbursement from Aventis, will be required in order for us to
continue our planned operations. We also anticipate seeking additional
product development opportunities through potential acquisitions or investments.
Such acquisitions or investments may consume cash reserves or require additional
cash or equity. Our working capital and additional funding requirements
will depend upon numerous factors, including: (i) the progress of our research
and development programs; (ii) the timing and results of pre-clinical testing
and clinical trials; (iii) the level of resources that we devote to sales
and marketing capabilities; (iv) technological advances; (v) the activities
of competitors; and (vi) our ability to establish and maintain collaborative
arrangements with others to fund certain research and development efforts,
to conduct clinical trials, to obtain regulatory approvals and, if such
approvals are obtained, to manufacture and market products.
Future minimum obligations at December 31, 2002 are as follows:
Operating | Drug Purchase | Convertible | |||||||
Leases | Commitments | Debt | |||||||
|
|
|
|||||||
($ thousands) | |||||||||
2003 | $ | 2,199 | $ | 27,500 | $ | - | |||
2004 | 2,478 | 27,500 | - | ||||||
2005 | 2,476 | - | - | ||||||
2006 | 2,585 | - | - | ||||||
2007 | 2,613 | - | - | ||||||
Thereafter | 5,581 | - | 10,000 | ||||||
|
|
|
|
|
|
||||
Total | $ | 17,932 | $ | 55,000 | $ | 10,000 | |||
|
|
|
|
|
|
The drug purchase commitments above are the maximum obligations provided in the manufacturing and supply agreement with Avecia Biotechnology Inc. See Note 19 to our consolidated financial statements for the fiscal year ended December 31, 2002. The manufacturing and supply agreement provides for mechanisms to mitigate costs should requirements be lower than anticipated and various performance criteria, which could lower the 2003 and 2004 commitments. For a further description of our agreement with Avecia, see Business Manufacturing.
Quantitative and Qualitative Disclosures about Market Risk |
Our carrying values of cash, marketable securities, accounts payable and
accrued expenses are a reasonable approximation of their fair value. The
estimated fair values of financial instruments have been determined by
us using available market information and appropriate valuation methodologies.
See Note 3 to our consolidated financial statements for the fiscal year
ended December 31, 2002.
However, considerable judgment is required in interpreting market data
to develop the estimates of fair value. Accordingly, the estimates utilized
in the consolidated financial statements are not necessarily indicative
of the amounts that we could realize in a current market exchange. We have
not entered into, and do not expect to enter into, financial instruments
for trading or hedging purposes. We do not currently anticipate entering
into interest rate swaps and/or similar instruments.
24
Because we have liquidated our wholly-owned subsidiary, Genta Pharmaceutical
Europe, S.A., we have no material currency exchange or interest rate risk
exposure as of December 31, 2002. With the liquidation, there will be no
ongoing exposure to material adverse effect on our business, financial
condition or results of operation for sensitivity to changes in interest
rates or to changes in currency exchange rates.
25
BUSINESS
Overview
Genta is a biopharmaceutical company dedicated to the identification, development and commercialization of novel drugs for cancer and related diseases. Our research portfolio consists of two major areas of focus:
| DNA/RNA Medicines, which are drugs based on chemical modifications of either deoxyribonucleic acid, or DNA, or ribonucleic acid, or RNA; and |
| Small Molecules. |
We recently
began marketing our first commercial product, Ganite, which is part of
our Small Molecule program. Ganite has been approved by the U.S. Food and
Drug Administration, or FDA, for treatment of cancer-related hypercalcemia
that is resistant to hydration. The drug is being marketed and sold exclusively
by Genta in the United States by our dedicated sales force that currently
consists of 18 regional representatives.
In September 2003, Genta reported Phase 3 clinical data for Genasense,
the lead product from our DNA/RNA Medicines program, in patients with advanced
malignant melanoma. We plan to include these data in our FDA New Drug Application,
or NDA, for Genasense, which we initiated on a rolling basis in August
2003 (i.e., we are filing the NDA in several sections with each section
being filed when completed). We expect to complete the NDA filing for use
of Genasense in combination with chemotherapy for patients with advanced
malignant melanoma in 2003.
We are pursuing further testing of both Ganite and Genasense in additional
indications. Ganite is currently undergoing clinical testing for use as
a cancer chemotherapy drug, especially in patients with non-Hodgkins lymphoma,
or NHL. Genasense is being tested as a drug that can increase the effectiveness
of current types of cancer therapy. We have completed patient enrollment
in two additional randomized Phase 3 trials that test the efficacy of Genasense
in patients with multiple myeloma and chronic lymphocytic leukemia, or
CLL. Genasense is also being tested in earlier clinical trials for treating
more than 10 other cancer types, including non-small cell lung cancer,
small cell lung cancer, NHL, acute and chronic leukemias, cancers of the
prostate, colon and breast and other diseases. Genasense has received designations
as Fast Track and Orphan Drug from the FDA in the advanced malignant
melanoma, multiple myeloma and CLL indications.
We have a series of agreements with Aventis to develop and commercialize
Genasense. Aventis is a major participant in the worldwide oncology market
and possesses one of the largest oncology sales forces in the United States.
Under these agreements, Aventis has committed to provide up to $476.9 million
in initial payments, milestone payments and for the purchase from us of
equity and convertible notes. In addition, Aventis is responsible for 75%
of development costs related to any U.S. NDA incurred by Genta or Aventis,
and substantially all other development, marketing and sales costs incurred
worldwide in connection with Genasense. Aventis has agreed to pay us royalties
on its exclusive worldwide net sales of Genasense, and to reimburse a portion
of our expense in building Gentas sales force to market Genasense in the
United States.
Our pre-clinical pipeline of DNA/RNA Medicines includes technologies known
as antisense, small interfering RNA molecules, or siRNA, and decoys, as
well as novel delivery system formulations that can increase the entry
of these drugs into cells. We recently acquired a private company, Salus
Therapeutics, Inc., or Salus, in order to strengthen our research and development
activities in the DNA/RNA Medicines program. The acquisition of Salus provides
a proprietary screening system that rapidly identifies hot spots or key
target areas in messenger RNA, which can be targeted using both antisense
oligonucleotides and RNAi; methods of using single-stranded small interfering
RNA and micro-RNA molecules to knockdown gene expression in target cells;
and a proprietary delivery platform designed to improve the pharmaceutical
properties of oligonucleotides.
26
In addition to Ganite, current activities in the Small Molecule program
include development of an oral formulation of a gallium-containing compound,
and several lead compounds for treatment of hormone-sensitive prostate
cancer, which are collectively known as Androgenics drugs.
We carry out our strategy by identifying and licensing or acquiring from
third parties early to mid-stage products and well-characterized targets.
We design and manage the pre-clinical and clinical testing of promising
products, which is carried out for us by contract research organizations.
Generally we expect to scale up, validate, conduct late-stage clinical
trials and commercialize our products in partnership with established businesses,
such as Aventis and Avecia for Genasense. Our own product quality and regulatory
staffs oversee FDA-regulated activities conducted by us or by our business
partners.
Strategy
Our goal is to establish Genta as a biopharmaceutical leader and preferred partner in the oncology market, and as direct marketers of our products in the United States. Our key strategies and objectives in this regard are:
Build on our foundation in oligonucleotide therapeutics to establish a leadership position in the treatment of cancer. |
We believe that drugs based on DNA and RNA are an important next-generation development that Genta is well-positioned to commercialize. We are committed to the discovery, clinical development and commercialization of these next-generation oncology drugs.
Establish Genasense as the preferred chemosensitizing drug for use in combination with other cancer therapies in a variety of human cancer types. |
We believe that Genasense will be more effective as a cancer drug used in conjunction with chemotherapy. We are testing Genasense in a variety of cancer types in order to establish its utility across many indications. We intend to complete the filing of our rolling NDA for Genasense in our first indication, advanced malignant melanoma, in 2003. We believe we are well-positioned for FDA approval of Genasense in 2004 for this indication. Assuming FDA approval, we intend to launch Genasense in the United States via a co-promotion with Aventis. Aventis plans to file for regulatory approval for Genasense in advanced malignant melanoma in countries outside the United States. We are entitled to royalties on all sales of Genasense by Aventis. We have completed enrollment in Phase 3 clinical testing of Genasense in patients with multiple myeloma and CLL. We expect to complete data analysis and report our results from those clinical trials in 2004. If one or both of these trials proves positive, we believe we can submit a follow-on NDA for Genasense in at least one of those diseases in 2004. In addition, in collaboration with Aventis and the National Cancer Institute, or NCI, we plan to initiate both non-randomized and randomized trials for treating eligible patients, based on their disease state, suffering from some of the most prevalent cancers, including lung, breast, prostate and colon cancers and NHL.
Establish Ganite for the treatment of NHL and other diseases. |
We have recently launched Ganite in the United States for the treatment of cancer-related hypercalcemia, and we intend to continue to commercialize the product for that indication. However, Ganite was originally developed as a chemotherapy agent, and published Phase 1 and Phase 2 studies have shown a high degree of clinical activity in several diseases, including NHL and bladder cancer. We are currently investigating the use of Ganite in Phase 2 clinical trials in patients with NHL, and we intend to pursue the clinical development of Ganite in this and other indications with the initiation of new clinical trials.
Continue to develop and strengthen our portfolio of R&D projects through internal development, licensing and acquisitions. |
We intend to continue to develop our other pipeline products for the treatment
of patients with cancer, including DNA/RNA Medicines (antisense, siRNA
and decoys) and Small Molecules (Androgenics
27
compounds and oral gallium). We intend to continue to evaluate acquisitions of complementary technologies.
Establish a strong presence in the U.S. oncology market. |
We plan to seek opportunities to license or acquire attractive new products,
well characterized targets, and technologies that could enable us to expand
our internal applied research and pre-clinical capabilities. We will continue
to strengthen our core competencies in clinical development and regulatory
and quality assurance. We also plan to build our U.S. sales and marketing
capabilities.
Genasense
The lead product from our DNA/RNA Medicines program is Genasense, an antisense oligonucleotide molecule that is designed to block the production of a protein known as Bcl-2. Current science suggests that Bcl-2 is a fundamental cause of the inherent resistance of cancer cells to current cancer treatments, such as chemotherapy, radiation or monoclonal antibodies. Blocking Bcl-2, therefore, may enable cancer treatments to be more effective. While Genasense has displayed some anticancer activity when used by itself, we believe it is more effective as a means of amplifying the effectiveness of other cancer therapies, principally by pre-treatment of patients with Genasense. Accordingly, we are seeking FDA approval of Genasense in conjunction with chemotherapy.
Programmed Cell Death |
The programmed death of cells is necessary to accommodate the billions
of new cells that are produced daily, and also to eliminate aged or damaged
cells. However, abnormal regulation of the programmed cell death process
can result in diseases.
Cancer is commonly associated with the over- or under-production of many types of proteins. These proteins may be directly cancer-causing (i.e., oncogenic) or they may contribute to the malignant nature of cancer (for instance, by increasing the longevity of cancer cells or making them more likely to spread throughout the body). We believe that the ability to selectively halt the production of certain proteins may make the treatment of certain diseases more effective. The process of programmed cell death is regulated by a large number of proteins, particularly members of the Bcl-2 protein family. In an effort to make existing cancer therapy more effective, Genta is developing Genasense to target and block the production of Bcl-2, a protein that is central to the process of programmed cell death also known as apoptosis.
Bcl-2 as an Inhibitor of Programmed Cell Death |
Normally, when a cancer cell is exposed to treatment, such as with chemotherapy,
radiation or immunotherapy, a death signal is sent to an organelle within
the cell called the mitochondrion. The mitochondrion then releases a factor
known as cytochrome C that activates a series of enzymes called caspases.
These enzymes cause widespread fragmentation of cellular proteins and DNA,
which ultimately causes cell death.
Bcl-2 is normally found in the mitochondrial membrane where it regulates
the release of cytochrome C. High levels of Bcl-2 are associated with most
types of human cancer, including major hematologic cancers such as lymphomas,
myeloma, and leukemia, and solid tumors such as melanoma and cancers of
the lung, colon, breast, and prostate. In these diseases, Bcl-2 inhibits
the release of cytochrome C that would ordinarily be triggered by cancer
therapy. Thus, Bcl-2 appears to be a major contributor to both inherent
and acquired resistance to cancer treatments. Overcoming resistance to
chemotherapy poses a major challenge for cancer treatment.
In cancer cells, Bcl-2 inhibits the process of programmed cell death, thereby
allowing cells to survive for much longer than normal cells. Genasense
has been developed as a chemosensitizing drug to block production of Bcl-2,
thereby dramatically increasing the sensitivity of cancer cells to standard
cancer treatment.
28
Antisense Technology |
Most of a cells functions, including whether the cell lives or dies, are
carried out by proteins. The genetic code for a protein is contained in
DNA, which is made up of bases known as nucleotides that are arranged in
a specific sequence. The specificity of the sequence accounts for the production
of a specific protein. In order for DNA to produce a protein, an intermediate
step is required. In this step, DNA is transcribed into messenger RNA,
or mRNA. The sequence of mRNA that encodes a protein is oriented in only
one direction, which is known as the sense orientation.
Antisense drugs are short sequences of chemically modified DNA bases that
are called oligonucleotides, or oligos. The oligos are engineered in a
sequence that is exactly opposite (hence anti) to the sense coding
orientation of mRNA. Because antisense drugs bind only short regions of
the mRNA (rather than the whole message itself), they contain far fewer
nucleotides than the whole gene. Moreover, since they are engineered to
bind only to the matching sequence on a specific mRNA, antisense drugs
have both high selectivity and specificity, which can be used to attack
production of a single, disease-causing protein. Genasense is an antisense
oligo that is designed to block the production of Bcl-2.
We have devoted significant resources towards the development of antisense oligos that contain a second generation phosphorothioate backbone, which is the nucleotide chain comprised of ribose and phosphate groups. However, we also have patents and technologies covering later third generation technologies that involve mixed phosphorothioate and methylphosphonate backbones, as well as sterically fixed chemical bonds, that may further enhance the molecules ability to bind to the intended target. Moreover, we have developed certain formulations of polymers that can be used to more efficiently increase the uptake of oligos into cells. Some of these advanced technologies may be incorporated into new DNA/RNA Medicines.
The Development of Genasense |
A number of pre-clinical studies in cell lines and in animals have shown
enhancement of tumor cell killing when Bcl-2 antisense was used in combination
with standard cancer therapies, including anti-metabolites, alkylating
agents, corticosteroids, other cytotoxic chemotherapy, radiation, and monoclonal
antibodies. Several studies have demonstrated enhanced antitumor activity
and durable tumor regression in animals engrafted with human cancers that
were treated with Bcl-2 antisense followed by antitumor agents that induce
programmed cell death. These studies include human lymphoma, melanoma,
breast cancer and prostate cancers, which were treated with Genasense in
combination with cyclophosphamide, dacarbazine, docetaxel and paclitaxel,
respectively.
Genasense has been in clinical trials since 1995 in both the United States
and Europe. We currently have efficacy and safety data on over 1,200 patients
in Phase 1, Phase 2 or Phase 3 clinical trials. These studies have been
conducted in patients with a wide variety of tumor types, including advanced
malignant melanoma, several types of leukemia, NHL and cancers of the prostate,
colon, lung, breast and other tumor types. Since 2001, Genta and the NCI
have jointly approved the initiation of approximately 20 new clinical trials.
In addition to making Genasense available to more physicians and patients,
these trials allow us to evaluate Genasense in certain diseases (and in
combination with other chemotherapy drugs) that would otherwise be outside
our initial priorities for clinical development. The overall results of
clinical trials performed to date suggest that Genasense can be administered
to cancer patients with acceptable side-effects, and that such treatment
may reduce the level of Bcl-2 protein in cancer cells.
The following chart sets forth the progress of our clinical trials with
respect to various potential indications for Genasense:
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Indication | Status |
Advanced Malignant Melanoma | Phase 3 fully enrolled;
rolling NDA
submission in progress |
Multiple Myeloma | Phase 3 (fully enrolled);
Phase 1-2 |
Chronic Lymphocytic Leukemia | Phase 3 (fully enrolled);
Phase 2 |
Acute Myelocytic Leukemia | Phase 2b;
Phase 2 |
Non-Small-Cell Lung Cancer | Phase 2b (randomized) |
Prostate Cancer | Phase 2 and 2b |
Small-Cell Lung Cancer (SCLC) | Phase 2b (randomized) |
Breast Cancer | Phase 1-2 |
Colorectal Cancer | Phase 1-2 |
Non-Hodgkins Lymphoma | Phase 1-2;
Phase 2 |
Kidney Cancer | Phase 2 |
Pancreatic Cancer (and other solid tumors) | Phase 1-2 |
Waldenstroms macroglobulinemia | Phase 1-2 |
Hepatocellular Carcinoma | Phase 1-2 |
Childhood Solid Tumors | Phase 1 |
To date, we have completed patient enrollment in three randomized Phase 3 trials, as follows:
Phase 3 Trial of Genasense Plus Chemotherapy in Patients with Advanced Malignant Melanoma |
On September 10, 2003, we and Aventis announced results from our Phase 3 clinical study of Genasense plus chemotherapy in patients with advanced malignant melanoma. The trial enrolled patients at 140 sites from 12 different countries. A total of 771 patients who had not been previously treated with chemotherapy were randomly assigned to receive dacarbazine, a standard chemotherapy drug, alone or in combination with Genasense. The primary endpoint of this trial was to compare the overall survival between the two treatment arms. Secondary endpoints included comparative analyses of progression-free survival and tumor response. The following results were obtained:
| Analysis of all patients on an intent-to-treat basis showed that the addition of Genasense to dacarbazine resulted in an estimated median survival of 9.1 months, compared with 7.9 months for patients treated with dacarbazine alone. The result was not statistically significant, as measured by a P-value of 0.184. Accordingly, we did not reach our primary endpoint. However, in part because both groups in the trial lived longer than we originally projected and because a substantial number of patients were accrued at a late stage into the trial, the analysis also revealed that a number of patients had not been followed for sufficiently long periods to establish the final median survival of this trial. For the 480 patients treated per-protocol who had completed a minimum follow-up of 12 months, the addition of Genasense resulted in a median survival of 10.1 months, compared with 8.1 months for dacarbazine alone. The P-value of this result was 0.035, which was statistically significant. |
| For the 771 patients from the intent-to-treat analysis, patients treated with Genasense plus dacarbazine showed a significant increase in median progression-free survival to 78 days, compared with 49 days for patients treated with dacarbazine alone. The P-value of this result was 0.001, which was statistically significant. |
| For the intent-to-treat population, 11.7% of the patients treated with Genasense plus dacarbazine experienced a 30% reduction in size of skin lesion (using RECIST criteria), compared with 6.8% for patients treated with dacarbazine alone. The P-value of this result was 0.019, which was statistically significant. |
30
| The addition of Genasense to dacarbazine did not appear to be associated with serious, previously unreported adverse reactions compared with the use of dacarbazine alone. |
We plan to include the foregoing data in our rolling NDA for Genasense, a process which we initiated in August 2003. We expect to complete that application in 2003. We have indicated to the FDA that we will update the overall survival analysis of this trial in 2004, and we expect to communicate this information along with our 120-day safety update to the FDA four months after we have completed filing the NDA.
Phase 3 Trial of Genasense Plus Chemotherapy in Patients with Multiple Myeloma |
We expect the completion in 2004 of a Phase 3 trial of Genasense plus chemotherapy in patients with multiple myeloma. This trial is directed at patients whose disease progressed despite chemotherapy. The primary goal of this trial is to increase the duration of response (or time to relapse) in patients treated with Genasense plus high-dose dexamethasone compared to dexamethasone alone. This trial completed enrollment of 220 patients as of December 2002, and follow-up of these patients is continuing.
Phase 3 Trial of Genasense Plus Chemotherapy in Patients with Chronic Lymphocytic Leukemia |
We expect the completion in 2004 of a Phase 3 trial of Genasense plus chemotherapy in patients with CLL. This trial is directed at patients whose disease progressed despite chemotherapy. The primary goal of this trial is to increase the proportion of patients who achieve a complete (or nodular partial) response after treatment with Genasense plus fludarabine/cyclophosphamide compared to fludarabine/cyclophosphamide alone. This trial completed enrollment of 241 patients in the second quarter of 2003, and follow-up of these patients is continuing.
Current Phase 1 and Phase 2 Trials |
In addition to the Phase 3 trials described above, Genasense is currently the subject of a number of other clinical trials, as indicated in the foregoing table, including randomized trials in patients with non-small cell lung cancer, prostate cancer and small cell lung cancer, and non-randomized trials in patients with NHL, acute and chronic leukemias, various solid tumors and other disorders.
Regulatory Status |
In the summer of 2003, we began submitting our NDA for Genasense to the
FDA on a rolling basis, and we expect to complete our application in
2003. We believe we are well-positioned for FDA approval of Genasense in
2004 for use in advanced malignant melanoma patients. However, the approval
is subject to a number of uncertainties, and we cannot assure you that
Genasense will be approved in this time frame or at all.
The FDA has granted several designations to Genasense that may expedite its regulatory review. These designations include:
| Fast track status for advanced malignant melanoma, multiple myeloma and CLL. The FDA fast track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The program allows sponsors to submit an NDA on a rolling basis. |
| Orphan drug designation for advanced malignant melanoma, multiple myeloma and CLL. An orphan drug is a drug which is intended to treat conditions that affect fewer than 200,000 people in the United States. Designation as an orphan drug allows the sponsors of drugs for rare diseases to qualify for tax credits and certain marketing exclusivity incentives under the Orphan Drug Act. |
31
In September 2003, Genta reported Phase 3 clinical data for Genasense,
the lead product from our DNA/RNA Medicines program, in patients with advanced
malignant melanoma. We plan to include this data in our NDA for Genasense,
which we initiated in August 2003.
For additional background information on the drug application process and
clinical trials, see Government Regulation.
We have applied for similar designations from regulatory agencies in Europe.
Commercialization Plan |
In April 2002, we announced an exclusive agreement with Aventis to jointly
develop and commercialize Genasense. We have agreed with Aventis that only
Aventis may sell Genasense. Genta will supply Aventis with Genasense on
a global basis. Aventis will pay us a royalty for all worldwide sales of
Genasense. Genta retains sole ownership of and exclusive title to the intellectual
property with respect to Genasense. We have jointly established an alliance
management committee consisting of representatives from both Genta and
Aventis to oversee the alliance.
In the United States, Genta and Aventis will jointly develop and co-promote
Genasense. Joint teams have been created under our collaborative agreement,
including a U.S. commercialization team that is responsible for coordinating
the development and implementation of commercialization of Genasense in
the United States. Genta is responsible for filing, prosecuting and maintaining
all patent applications and patents in the United States. Aventis will
reimburse Genta for the cost of an escalating number of Genta sales representatives
throughout the United States.
In all countries outside of the United States, Aventis will have exclusive
development and marketing rights and regulatory responsibilities. Genta
retains responsibility for filing, prosecuting and maintaining all patent
applications and patents outside of the United States.
Ganite
Hypercalcemia |
On October 6, 2003, we began marketing Ganite for the treatment of cancer-related
hypercalcemia. Ganite is our first drug to receive marketing approval,
and our oncology sales force currently comprising 18 regional representatives
is now promoting the product in the United States.
Hypercalcemia is a life-threatening condition caused by excessive buildup
of calcium in the bloodstream, which may occur in up to 20% of cancer patients.
Gallium nitrate was originally studied by the NCI as a new type of cancer
chemotherapy. More than 1,000 patients were treated in Phase 1 and Phase
2 trials, and the drug showed promising antitumor activity against NHL,
bladder cancer and other diseases. In the course of these studies, gallium
nitrate was also shown to strongly inhibit bone resorption. Gallium nitrate
underwent additional clinical testing and was approved by the FDA in 1991
as a treatment for cancer-related hypercalcemia. Lower doses of Ganite
were also tested in patients with less severe bone loss, including bone
metastases, a cancer that has spread to bone, Pagets disease, an affliction
of older patients that causes pain and disability, and osteoporosis.
Side effects of Ganite include nausea, diarrhea and kidney damage. (A complete
listing of Ganites side effects is contained in the products Package
Insert that has been reviewed and approved by the FDA.) We believe the
development of methods to administer Ganite in the outpatient setting will
improve the commercial prospects for Ganite as compared to when it was
originally introduced.
The extension for an important patent covering the use of Ganite for its
approved indication will expire in 2005. Genta has filed and continues
to file patent applications seeking intellectual property protection for
Ganite. In addition, Genta intends to seek orphan drug designation for
the use of Ganite for the treatment of NHL.
32
Non-Hodgkins Lymphoma and Other Cancer Types |
Based on previously published data, we believe that Ganite may also be an effective treatment for patients with certain types of cancer, particularly NHL. We have been granted an investigational new drug exemption, or IND, and we have commenced clinical trials of Ganite for the treatment of patients with relapsed NHL. We have also filed an orphan drug application for this use and we plan to seek expanded marketing approval for this indication. Approximately 54,000 new cases of NHL are diagnosed in the United States each year. We are planning to evaluate Ganite in other indications, such as bladder cancer and pancreatic cancer. Previous clinical trials of Ganite showed that it does not cause significant myelosuppression, a decrease of bone marrow activity often associated with cancer therapy, that causes decreased production of platelets and white blood cells. We believe this feature will allow Ganite to be readily incorporated into combination chemotherapy regimens that employ other drugs that cause myelosuppression.
Regulatory Status |
In April 2000, we acquired assets, rights, licenses to patents, and technology
relating to gallium-containing compounds for treatment of bone loss, and
to Ganite (gallium nitrate injection), the liquid injectable product. The
acquired assets included the ownership of an approved NDA relating to Ganite.
Since this acquisition, we have worked with the FDA to address certain
regulatory issues and to update certain aspects of drug manufacturing.
In the first quarter of 2003, we filed a supplemental NDA for Ganite for
the treatment of cancer-related hypercalcemia that has not responded to
hydration. On September 18, 2003, we received approval from the FDA to
market Ganite for the treatment of cancer-related hypercalcemia that is
resistant to hydration.
Given the extensive published data on the anticancer activity of gallium
nitrate, we filed a new IND request for Ganite with the Oncology Drug Products
Division at the FDA for the treatment of patients with relapsed NHL. Under
this IND, we initiated a clinical trial of Ganite in NHL patients in 2002.
Genta has also submitted an application to the FDA to designate gallium
nitrate as an orphan drug in NHL.
Other Pipeline Products and Technology Platforms
Oral Gallium |
We are currently planning to develop new formulations of gallium-containing compounds that can be taken orally. These formulations may be useful for diseases in which long term, low-dose therapy is deemed desirable. We believe that such formulations will be useful for the treatment of patients who have chronic bone loss diseases, such as bone metastases, Pagets disease and osteoporosis. Such patients are commonly afflicted by bone pain and susceptibility to fractures.
Decoys |
In addition to the antisense program, we are developing compounds known
as decoys, which are short strands of DNA or RNA that bind certain proteins
known as transcription factors. Normally, transcription factors bind to
specific portions of DNA known as response elements and regulate the functions
of genes in a positive or negative fashion (i.e., they can turn genes on
or off). When a cell is flooded with an excess of decoys, these decoys
compete with response elements to bind transcription factors and inactivate
them. By selectively inactivating the transcription factor, the function
of the gene can be regulated in a positive or negative manner. This type
of control could potentially be used to regulate genes that are critically
involved in cancer progression.
In December 2000, Genta licensed patents and technology relating to decoys
from the NIH. Our current program is targeting a transcription factor known
as the cyclic adenosine monophosphate response element binding protein,
or CRE-BP. Pre-clinical studies conducted at the NIH have shown broad anticancer
activity for this compound, with very low toxicity to normal cells. The
CRE-BP decoy is currently undergoing additional pre-clinical testing.
33
Androgenics |
In connection with the acquisition of Androgenics Technologies, Inc. in
1999, we acquired rights to a series of compounds that may ultimately be
useful to treat patients with hormone-sensitive prostate cancer. These
Androgenics compounds have two principal actions: first, they block the
synthesis of androgen hormones, such as testosterone, that simulate the
growth of prostate cancer cells; second, they inactivate androgen receptors,
which are proteins that bind androgen hormones and mediate their effects.
These types of activities suggest that these drugs could be useful for
patients with early stage prostate cancer. Genta is currently evaluating
whether to bring forward a lead compound into late-stage pre-clinical testing
from this program.
Patents
and Proprietary Technology
It is our policy to protect our technology by filing patent applications
with respect to technologies important to our business development. To
maintain our competitive position, we also rely upon trade secrets, unpatented
know-how, continuing technological innovation, licensing opportunities
and certain regulatory approvals (such as orphan drug designations).
We own or have licensed several patents and applications to numerous aspects of oligonucleotide technology, including novel compositions of matter, methods of large-scale synthesis, methods of controlling gene expression and methods of treating disease. Gentas patent portfolio includes both U.S. and foreign applications and patents. To date, Genta has approximately 100 U.S. and foreign patent applications. Gentas portfolio of owned or licensed patents includes approximately 50 issued U.S. patents and approximately 13 pending U.S. patent applications. Genta endeavors to seek appropriate U.S. and foreign patent protection on its oligonucleotide technology.
In the United States, a patent filed on or before June 8, 1995 expires
the later of 17 years from the issue date or 20 years from the date on
which the application for patent was filed in the United States or the
earliest claimed priority date. A patent filed after June 8, 1995 expires
20 years from the date on which the application for patent was filed in
the United States or the earliest claimed priority date.
Genta has licensed six U.S. patents relating to Genasense that expire between
2008 and 2015, two pending U.S. patent applications that relate to Genasense,
and approximately 45 foreign patent applications that are pending relating
to Genasense. Genta also owns three U.S. patent applications relating to
methods of using Genasense.
Included among Gentas property rights are certain rights licensed from
the NIH covering phosphorothioate oligonucleotides. We also acquired from
the University of Pennsylvania exclusive rights to antisense oligonucleotides
directed against the Bcl-2 mRNA, as well as methods of their use for the
treatment of cancer. In 1998, two U.S. patents were issued encompassing
our licensed antisense oligonucleotide compounds targeted against the Bcl-2
mRNA and the use of these compounds outside of organisms. These claims
cover our proprietary antisense oligonucleotide molecules, which target
the Bcl-2 mRNA including our lead clinical candidate, Genasense. Other
related U.S. and corresponding foreign patent applications are still pending.
The patent covering the use of Ganite for its approved indication will
expire in 2005. Genta has filed and continues to file patent applications
seeking intellectual property protection for Ganite.
In May 2000, we entered into a licensing arrangement with Molecular Biosystems,
Inc. for a broad portfolio of patents and technology that relates to antisense
for therapeutic and diagnostic applications. The arrangement included a
grant of both exclusive and non-exclusive rights from Molecular Biosystems,
Inc. to Genta on a royalty-free basis in return for cash and shares of
common stock.
The patent positions of biopharmaceutical and biotechnology firms, including
Genta, can be uncertain and can involve complex legal and factual questions.
Consequently, even though we are currently prosecuting our patent applications
with the United States and foreign patent offices, we do not know
34
whether any
of our applications will result in the issuance of any patents, or if any
issued patents will provide significant proprietary protection, or even
if successful that these patents will not be circumvented or invalidated.
Even if issued, patents may be circumvented or challenged and invalidated
in the courts. Because some applications in the United States are kept
in secrecy until an actual patent issues, we cannot be certain that others
have not filed patent applications directed at inventions covered by our
pending patent applications, or that we were the first to file patent applications
for such inventions. Thus, we may become involved in interference proceedings
declared by the U.S. Patent and Trademark Office (or comparable foreign
office or process) in connection with one or more of our patents or patent
applications to determine priority of invention, which could result in
substantial costs to us, as well as an adverse decision as to priority
of invention of the patent or patent application involved.
Competitors or potential competitors may have filed applications for, or
have received patents and may obtain additional patents and proprietary
rights relating to, compounds or processes competitive with those of ours.
Accordingly, there can be no assurances that our patent applications will
result in issued patents or that, if issued, the patents will afford protection
against competitors with similar technology. We cannot provide assurance
that any patents issued to Genta will not be infringed or circumvented
by others, nor can there be any assurance that we will obtain necessary
patents or technologies or the rights to use such technologies.
We also rely upon unpatented trade secrets. No assurances can be given
as to whether third parties will independently develop substantially equivalent
proprietary information and techniques, or gain access to our trade secrets,
or disclose such technologies to the public, or that we can meaningfully
maintain and protect unpatented trade secrets.
We require our employees, consultants, outside scientific collaborators,
sponsored researchers and other advisors to execute confidentiality agreements
with us. These agreements generally provide that all confidential information
developed or made known to an individual during the course of the individuals
relationship with Genta shall be kept confidential and shall not be disclosed
to third parties except in specific circumstances. In the case of employees,
the agreement generally provides that all inventions conceived by the individual
shall be assigned to, and made the exclusive property of, Genta. There
can be no assurance, however, that these agreements will provide meaningful
protection to our trade secrets, or guarantee adequate remedies in the
event of unauthorized use or disclosure of confidential proprietary information,
or in the event of an employees refusal to assign any patents to Genta
in spite of his/her contractual obligation.
Research
and Development
In addition to our current focus in the areas described above, we continually
evaluate our programs in light of the latest market information and conditions,
the availability of third-party funding, technological advances and other
factors. As a result of such evaluations, we change our product development
plans from time to time and anticipate that we will continue to do so.
We recorded net research and development expenses of $5.0 million, $58.9
million, $39.4 million and $6.8 million during the six months ended June
30, 2003 and the years ended December 31, 2002, 2001 and 2000, respectively.
Sales and
Marketing
Our 18-person oncology sales force began selling Ganite for use in the
treatment of cancer-related hypercalcemia on October 6, 2003. We have 29
employees dedicated to sales and marketing and are currently considering
an expansion of our sales force by 17 additional individuals to support
the anticipated launch of Genasense. This expansion would be subsidized
by Aventis as described below.
In April 2002, we entered into a series of agreements relating to the development
and commercialization of Genasense, to which we refer collectively as the
collaborative agreement with Aventis and its affiliates. Under the terms
of our collaborative agreement, Genta and Aventis will jointly develop
and commercialize Genasense in the United States, and Aventis will have
exclusive development and marketing rights to the compound in all countries
outside of the United States. We
35
retain responsibility
for global manufacturing and for regulatory filings within the United States,
while Aventis has assumed all regulatory responsibilities outside the United
States. Joint management teams, including representatives from both Genta
and Aventis, currently oversee the joint efforts of Genta and Aventis in
developing and commercializing Genasense in the United States. Under our
collaborative agreement, Aventis has committed to provide up to $476.9
million in initial payments, milestone payments and for the purchase from
us of equity and convertible notes. In addition, we are entitled to royalties
on Aventis exclusive worldwide net sales of Genasense, from which we are
required to pay third-party pass-through royalties to the University of
Pennsylvania and The National Institutes of Health, or NIH, based on net
worldwide sales of Genasense. Furthermore, under our collaborative agreement,
Aventis has agreed to pay 75% of development costs related to any U.S.
NDA incurred by either Genta or Aventis subsequent to the execution of
our collaborative agreement, and substantially all other development, marketing,
and sales costs incurred worldwide. Aventis will also reimburse a portion
of our expense in building our sales force to market Genasense in the United
States. Genta has received a total of $214.0 million in initial and near-term
funding, which included a $10.0 million licensing fee and $40.0 million
in development funding, $10.0 million in convertible debt proceeds, $71.9
million pursuant to an at-market equity investment in our common stock,
$57.1 million in paid expense reimbursements and $25.0 million in line
of credit proceeds. The commercialization agreement may be terminated by
Aventis with six months notice. For additional discussion of the collaborative
agreement, see Note 12 to our consolidated financial statements for the
fiscal year ended December 31, 2002.
Either alone or in partnerships with other companies, we intend to be a
direct marketer or co-marketer of our pharmaceutical products by continuing
to build a sales and marketing infrastructure in the United States to launch
and fully realize the commercial potential of our products. For international
product sales, we intend to distribute our products through collaborations
with third parties.
Manufacturing
Our ability to conduct clinical trials on a timely basis, to obtain regulatory
approvals and to commercialize our products will depend in part upon our
ability to manufacture our products, either directly or through third parties,
at a competitive cost and in accordance with applicable FDA and other regulatory
requirements, including current Good Manufacturing Practice regulations.
We currently rely on third parties to manufacture our products. In December
2002, we signed a five-year manufacturing and supply agreement with Avecia
Biotechnology, Inc., or Avecia, a leading multinational manufacturer of
pharmaceutical products, to supply quantities of Genasense. This
agreement is also renewable beyond the initial five-year period. In 2004,
we expect to be obligated to purchase $27.5 million in drug substances
from Avecia. Pursuant to our collaborative agreement with Aventis,
we anticipate that we will be reimbursed for at least 75% of the drug purchases
from Avecia once Genasense is shipped to the clinical sites or Aventis
distribution sites. In addition, we have committed up to $5.0 million of
advance financing to Avecia for facility expansion, which will be recovered
with interest through future purchase payments to be made by us to Avecia.
We believe these arrangements are sufficient for our medium-term production
needs with respect to Genasense.
Human Resources
As of September 30, 2003, Genta had 151 employees, 31 of whom hold doctoral
degrees. There are 95 employees engaged in research, development and other
technical activities, 29 employees in sales and marketing and 27 in administration.
None of Gentas employees is represented by unions. Most of the management
and professional employees of Genta have had prior experience and positions
with pharmaceutical and biotechnology companies. Genta believes it maintains
satisfactory relations with its employees and has not experienced interruptions
of operations due to labor disagreements.
Government
Regulation
Regulation by governmental authorities in the United States and foreign
countries is a significant factor in our ongoing research and product development
activities and in the manufacture and marketing
36
of our proposed
products. All of our therapeutic products will require regulatory approval
by governmental agencies prior to commercialization. In particular, human
therapeutic products are subject to rigorous pre-clinical and clinical
testing and pre-market approval procedures by the FDA and similar authorities
in foreign countries. Various federal, and in some cases, state statutes
and regulations also govern or affect the development, testing, manufacturing,
safety, labeling, storage, recordkeeping and marketing of such products.
The lengthy process of seeking these approvals, and the subsequent compliance
with applicable federal and, in some cases, state statutes and regulations,
require substantial expenditures. Any failure by Genta, our collaborators
or our licensees to obtain, or any delay in obtaining, regulatory approvals
could adversely affect the marketing of our products and our ability to
receive products or royalty revenue.
The activities required before a new pharmaceutical agent may be marketed
in the United States begin with pre-clinical testing. Pre-clinical tests
include laboratory evaluation of product chemistry and animal studies to
assess the potential safety and efficacy of the product and its formulations.
The results of these studies must be submitted to the FDA as part of an
IND. An IND becomes effective within 30 days of filing with the FDA unless
the FDA imposes a clinical hold on the IND. In addition, the FDA may, at
any time, impose a clinical hold on ongoing clinical trials. If the FDA
imposes a clinical hold, clinical trials cannot commence or recommence,
as the case may be, without prior FDA authorization and then only under
terms authorized by the FDA.
Clinical trials are generally categorized into four phases.
Phase 1 trials are initial safety trials on a new medicine in which investigators
attempt to establish the dose range tolerated by a small group of patients
using single or multiple doses, and to determine the pattern of drug distribution
and metabolism.
Phase 2 trials are clinical trials to evaluate efficacy and safety in patients
afflicted with a specific disease. Typically, Phase 2 trials in oncology
comprise 14 to 50 patients. Objectives may focus on dose-response, type
of patient, frequency of dosing or any of a number of other issues involved
in safety and efficacy. Phase 2a trials are pilot studies while Phase 2b
trials typically incorporate more patients than Phase 2a trials in order
to more precisely establish efficacy.
In the case of products for life-threatening diseases, the initial human
testing is generally done in patients rather than in healthy volunteers.
Since these patients are already afflicted with the target disease, it
is possible that such studies may provide results traditionally obtained
in Phase 2 trials.
Phase 3 trials are usually multi-center, comparative studies that involve
larger populations. These trials are generally intended to be pivotal in
importance for the approval of a new drug. In oncology, Phase 3 trials
typically involve 100 to 1,000 patients for whom the medicine is eventually
intended. Trials are also conducted in special groups of patients or under
special conditions dictated by the nature of the particular medicine and/or
disease. Phase 3 trials often provide much of the information needed for
package insert and labeling of the medicine. A trial is fully enrolled
when it has a sufficient number of patients to provide enough data for
the statistical proof of efficacy and safety required by the FDA and others.
Phase 3b trials are conducted after submission of a new drug application,
but before the products approval for market launch. Phase 3b trials may
supplement or complete earlier trials, or they may seek different kinds
of information, such as quality of life or marketing. Phase 3b is the period
between submission for approval and receipt of marketing authorization.
After a medicine is marketed, Phase 4 trials provide additional details
about the products safety and efficacy.
The results of the pre-clinical and clinical testing, together with chemistry,
manufacturing and control information, are then submitted to the FDA for
a pharmaceutical product in the form of an NDA, for a biological product
in the form of a biologics license application and for a particular medical
device in the form of a premarket approval application in order to obtain
approval to commence commercial sales. In responding to an NDA, biologics
license application or premarket approval application, the FDA may
37
grant marketing
approval, request additional information or deny the application if it
determines that the application does not satisfy its regulatory approval
criteria. There can be no assurance that the approvals that are being sought
or may be sought by Genta in the future will be granted on a timely basis,
if at all, or if granted will cover all the clinical indications for which
we are seeking approval or will not contain significant limitations in
the form of warnings, precautions or contraindications with respect to
conditions of use.
In circumstances where a company intends to develop and introduce a novel
formulation of an active drug ingredient already approved by the FDA, clinical
and pre-clinical testing requirements may not be as extensive. Limited
additional data about the safety and/or effectiveness of the proposed new
drug formulation, along with chemistry and manufacturing information and
public information about the active ingredient, may be satisfactory for
product approval. Consequently, the new product formulation may receive
marketing approval more rapidly than a traditional full new drug application,
although no assurance can be given that a product will be granted such
treatment by the FDA.
For clinical investigation and marketing outside the United States, we
are or may be subject to foreign regulatory requirements governing human
clinical trials and marketing approval for drugs. The requirements governing
the conduct of clinical trials, product licensing, pricing and reimbursement
vary widely from country to country. Our approach is to design our European
clinical trial studies to meet FDA, European Economic Community, or EEC,
and other European countries standards. At present, the marketing authorizations
are applied for at a national level, although certain EEC procedures are
available to companies wishing to market a product in more than one EEC
member state. If the competent authority is satisfied that adequate evidence
of safety, quality and efficacy has been presented, a market authorization
will be granted. The registration system proposed for medicines in the
EEC after 1992 is a dual one in which products, such as biotechnology and
high technology products and those containing new active substances, will
have access to a central regulatory system that provides registration throughout
the entire EEC. Other products will be registered by national authorities
under the local laws of each EEC member state. With regulatory harmonization
finalized in the EEC, our clinical trials will be designed to develop a
regulatory package sufficient for multi-country approval in our European
target markets without the need to duplicate studies for individual country
approvals. This approach also takes advantage of regulatory requirements
in some countries, such as in the United Kingdom, which allow Phase 1 studies
to commence after appropriate toxicology and pre-clinical pharmacology
studies, prior to formal regulatory approval.
Prior to the enactment of the Drug Price Competition and Patent Term Restoration
Act of 1984, or the Waxman/Hatch Act, the FDA, by regulation, permitted
certain pre-1962 drugs to be approved under an abbreviated procedure which
waived submission of the extensive animal and human studies of safety and
effectiveness normally required to be in a new drug application. Instead,
the manufacturer only needed to provide an abbreviated new drug application
containing labeling, information on chemistry and manufacturing procedures
and data establishing that the original pioneer product and the proposed
generic product are bioequivalent when administered to humans.
Originally, the FDAs regulations permitted this abbreviated procedure
only for copies of a drug that was approved by the FDA as safe before 1962
and which was subsequently determined by the FDA to be effective for its
intended use. In 1984, the Waxman/Hatch Act extended permission to use
the abbreviated procedure established by the FDA to copies of post-1962
drugs subject to the submission of the required data and information, including
data establishing bioequivalence. However, approval of such abbreviated
new drug applications was dependent upon there being no outstanding patent
or non-patent exclusivity.
Additionally, the FDA allows, under section 505(b)(2) of the Food Drug
and Cosmetic Act, for the submission and approval of a hybrid application
for certain changes in drugs which, but for the changes, would be eligible
for an effective abbreviated new drug application approval. Under these
procedures the applicant is required to submit the clinical efficacy and/or
safety data necessary to support the changes from the abbreviated new drug
application-eligible drug (without submitting the basic underlying safety
and efficacy data for the chemical entity involved) plus manufacturing
and chemistry data and information.
38
Approval of
a 505(b)(2) application is dependent upon the abbreviated new drug application
being subject to no outstanding patent or non-patent exclusivity. As compared
to a new drug application, an abbreviated new drug application or a 505(b)(2)
application typically involves reduced research and development costs.
However, there can be no assurance that any such applications will be approved.
Furthermore, the supply of raw materials must also be approved by the FDA.
We and our third-party manufacturers are also subject to various foreign,
federal, state and local laws and regulations relating to health and safety,
laboratory and manufacturing practices, the experimental use of animals
and the use, manufacture, storage, handling and disposal of hazardous or
potentially hazardous substances, including radioactive compounds and infectious
disease agents, used in connection with our research and development work
and manufacturing processes. We currently incur costs to comply with laws
and regulations and these costs may become more significant.
Competition
In many cases, our products under development will be competing with existing
therapies for market share. In addition, a number of companies are pursuing
the development of antisense technology and controlled-release formulation
technology and the development of pharmaceuticals utilizing such technologies.
We compete with fully integrated pharmaceutical companies that have substantially
more experience, financial and other resources and superior expertise in
research and development, manufacturing, testing, obtaining regulatory
approvals, marketing and distribution. Smaller companies may also prove
to be significant competitors, particularly through their collaborative
arrangements with large pharmaceutical companies or academic institutions.
Furthermore, academic institutions, governmental agencies and other public
and private research organizations have conducted and will continue to
conduct research, seek patent protection and establish arrangements for
commercializing products. Such products may compete directly with any products
that may be offered by us.
Our competition will be determined in part by the potential indications
for which our products are developed and ultimately approved by regulatory
authorities. For certain of our potential products, an important factor
in competition may be the timing of market introduction of our or our competitors
products. Accordingly, the relative speed with which we can develop products,
complete the clinical trials and approval processes and supply commercial
quantities of the products to the market are expected to be important competitive
factors. We expect that competition among products approved for sale will
be based, among other things, on product efficacy, safety, reliability,
availability, price, patent position and sales, marketing and distribution
capabilities. The development by others of new treatment methods could
render our products under development non-competitive or obsolete.
Our competitive position also depends upon our ability to attract and retain
qualified personnel, obtain patent protection or otherwise develop proprietary
products or processes and secure sufficient capital resources for the often
substantial period between technological conception and commercial sales.
Properties
In November 2000, we relocated our headquarters from Lexington, Massachusetts
to Berkeley Heights, New Jersey. We now lease approximately 93,000 square
feet of office space in Berkeley Heights. Our annual rental costs for this
space are approximately $2.52 million. Our lease on this space terminates
in 2010.
Our Salus facilities in Utah currently consist of 5,357 square feet of
laboratory and office space at an annual cost of $0.11 million. We recently
signed a five-year lease on 11,178 square feet of laboratory and office
space at an annual rental cost of $0.19 million. The current lease will
terminate when we occupy the newly-leased space, which we expect to occur
in February 2004.
39
Legal Proceedings
JBL Scientifics, Inc. |
During May 2000, Promega notified Genta of two claims against Genta and
Gentas subsidiary, Genko Scientific, Inc. (formerly known as JBL Scientifics,
Inc.), for indemnifiable damages in the aggregate amount of $2.82 million
under the purchase agreement pursuant to which Promega acquired the assets
of JBL. Promegas letter stated that it intended to reduce to zero the
principal amount of the $1.2 million promissory note it issued as partial
payment for the assets of Genko Scientific, Inc. and that therefore Genta
owed Promega approximately $1.6 million. On October 16, 2000 Genta filed
suit in a U.S. District Court in California against Promega for the non-payment
of the $1.2 million note plus accrued interest. On November 6, 2000, Promega
filed a counterclaim alleging indemnifiable damages in the aggregate amount
of $2.82 million. During the first quarter of 2001, we agreed to resolve
the matter with Promega, and, in connection therewith, agreed to restructure
its $1.2 million promissory note receivable to provide for a $0.2 million
non-interest bearing note due to be repaid by Promega upon final resolution
of certain environmental issues related to JBL and forgave all accrued
interest. While we have resolved one of these environmental issues, we are awaiting final acceptance by the EPA of our settlement
offer on the other environmental issue before the restructured note will be repaid by Promega.
We are uncertain as to whether and when the EPA will issue such final acceptance.
Genta Pharmaceutical
Europe S.A.
During 1995, Genta Pharmaceutical Europe S.A., or Genta Europe, a wholly-owned
subsidiary of Genta, received funding in the form of a loan from ANVAR,
a French government agency, of which the proceeds were intended to fund
research and development activities. In October 1996, in connection with
a restructuring of Gentas operations, Genta terminated all scientific
personnel of Genta Europe. In 1998, ANVAR asserted that Genta Europe was
not in compliance with the ANVAR Agreement, notified Genta Europe of its
demand for accelerated repayment of the loan and notified Genta that it
was liable as a guarantor on the note. Based on the advice of French counsel,
Genta does not believe that ANVAR is entitled to payment under the terms
of the ANVAR Agreement, and that Genta will likely incur any liability
in this matter, although there can be no assurances thereof. At June 30,
2003, we have accrued a net liability of $0.212 million related to this
matter, which management believes is adequate to provide for this contingency.
University
of Pennsylvania
In October 2002, a licensing officer from the University of Pennsylvania
asserted a claim to a portion of the initial $40.0 million development
funding we received from Aventis pursuant to the collaborative agreement
between Genta and Aventis. In October 2003, we reached a settlement with
the University of Pennsylvania with respect to this claim. Under the terms
of the settlement, in exchange for an agreement by the University of Pennsylvania
to forego any and all claims in the future to any portion of any milestone
and other payments (other than royalty payments on sales) made to Genta
pursuant to the collaborative agreement, Genta has agreed to make the following
payments to the University of Pennsylvania: (i) $750,000 on November 5, 2003, (ii)
$250,000 on February 2, 2004, (iii) $1.5 million upon the first new drug
application or foreign equivalent approval of Genasense and (iv) provided
that the first new drug application or foreign equivalent approval of Genasense
has been received by Genta, $750,000 on the earlier of (a) the second new
drug application or foreign equivalent approval of Genasense or (b) December
30, 2004.
40
MANAGEMENT
Directors and Executive Officers of Genta.
Name
|
Age
|
Position
|
Raymond P. Warrell, Jr., M.D | 54 | Chairman of the Board of Directors and Chief Executive Officer |
William P. Keane | 48 | Vice President, Chief Financial Officer and Corporate Secretary |
Loretta M. Itri, M.D | 54 | President, Pharmaceutical Development, and Chief Medical Officer |
Bruce A. Williams | 48 | Senior Vice President, Sales and Marketing |
Robert E. Klem, Ph.D.(1) | 59 | Vice President and Chief Technical Officer |
Jerome E. Groopman, M.D.(2) | 51 | Director |
Betsy McCaughey, Ph.D.(2) | 55 | Director |
Daniel D. Von Hoff, M.D.(3) | 56 | Director |
Harlan J. Wakoff(3)(4) | 37 | Director |
Douglas G. Watson(3)(4) | 58 | Director |
Michael S. Weiss(2)(3) | 37 | Director |
Patrick J. Zenner(3)(4) | 56 | Director |
(1) | Retired as of January 1, 2003. |
(2) | Member of the Nominating and Corporate Governance Committee of the Board of Directors. |
(3) | Member of the Compensation Committee of the Board of Directors. |
(4) | Member of the Audit Committee of the Board of Directors. |
Raymond P. Warrell, Jr., M.D., 54, has been Chief Executive
Officer and a member of the Board of Directors of Genta since December
1999 and Chairman since January 2001. From December 1999 to May 2003, he
was also President of Genta. From 1980 to 1999, Dr. Warrell was associated
with the Memorial Sloan-Kettering Cancer Center in New York, where he held
tenured positions as Member, Attending Physician, and Associate Physician-in-Chief,
and with the Joan and Sanford Weill Medical College of Cornell University,
where he was Professor of Medicine. Dr. Warrell also has more than 20 years
of development and consulting experience in pharmaceuticals and biotechnology
products. He was a co-founder and chairman of the scientific advisory board
of PolaRx Biopharmaceuticals, Inc., manufacturers of Trisenox(R), a drug
for the treatment of acute promyelocytic leukemia, which was acquired by
Cell Therapeutics, Inc. in January 2000. Dr. Warrell holds or has filed
numerous patents and patent applications for biomedical therapeutic or
diagnostic agents. He has published more than 100 peer-reviewed papers
and more than 240 book chapters and abstracts, most of which are focused
upon drug development in tumor-related diseases. Dr. Warrell is a member
of the American Society of Clinical Investigation, the American Society
of Hematology, the American Association for Cancer Research and the American
Society of Clinical Oncology. Among many awards, he has received the U.S.
Public Health Service Award for Exceptional Achievement in Orphan Drug
Development from the FDA. Dr. Warrell is married to Dr. Loretta M. Itri,
President, Pharmaceutical Development and Chief Medical Officer of Genta.
Jerome E. Groopman M.D., 51, has been a member of Gentas
Board of Directors since November 2002. Dr. Groopman, who is Professor
of Medicine and Chief of Experimental Medicine at the Beth Israel Deaconess
Medical Center in Boston, also holds the Dina and Raphael Recanati Chair
of Medicine at Harvard. Dr. Groopman has an extensive record of achievement
in basic and clinical research related to cancer, hematology, and HIV infection.
He has served on the Advisory Council to the National Heart, Lung and Blood
Institute for AIDS-related diseases. He was Chairman of the Advisory Committee
to the FDA for Biological Response Modifiers. In 2000, Dr. Groopman was
elected to the Institute of Medicine of the National Academy of Sciences.
Dr. Groopman also serves on many scientific editorial boards and has authored
and published more than 150 scientific articles. Recently, he has written
two books relating to the devastating personal impact of disease in people
afflicted with AIDS and cancer entitled, The
41
Measure of
Our Days, and Second Opinions: Stories of Intuition and Choice in the
Changing World of Medicine. Among other periodicals, he is a frequent
contributor to The New Yorker magazine, where he is staff writer on medicine
and biology.
Loretta M. Itri, M.D., F.A.C.P., 54, was appointed President,
Pharmaceutical Development and Chief Medical Officer in May 2003 and was
Executive Vice President, Clinical Development and Chief Medical Officer
from March 2001 to May 2003. Previously, Dr. Itri was Senior Vice President,
Worldwide Clinical Affairs, and Chief Medical Officer at Ortho Biotech
Inc., a Johnson & Johnson company, from November 1990 until January
2000. As the senior clinical leader at Ortho Biotech and previously at
J&Js R.W. Johnson Pharmaceutical Research Institute (PRI), she led
the clinical teams responsible for new drug application approvals for Procrit®.
She had similar leadership responsibilities for the approvals of Leustatin,
Renova, Topamax, Levofloxin, and Ultram. Prior to joining J&J,
Dr. Itri was associated with Hoffmann-La Roche Inc. from June 1982 until
November 1990, most recently as Assistant Vice President and Senior Director
of Clinical Investigations, where she was responsible for all phases of
clinical programs in Immunology, Infectious Diseases, Antivirals, AIDS,
Hematology, and Oncology. Under her leadership in the areas of recombinant
proteins, cytotoxic drugs and differentiation agents, she compiled the
first successful Product License Application (PLA) for an interferon product
(Roferon-A; interferon alfa). Dr. Itri is married to Dr. Raymond P. Warrell,
Chief Executive Officer and Chairman of the Board of Directors of Genta.
William P. Keane, 48, has been Vice President and Chief
Financial Officer since October 2002, and was appointed Corporate Secretary
in November 2002. Previously, he was Vice President of Sourcing, Strategy,
and Operations Effectiveness at Bristol Myers Squibb, Inc. From 2000 to
2001, Mr. Keane served as CFO of Covance Biotechnology Services Inc., and
from 1997 to 2000, he was Vice-President of Finance within the Global Manufacturing
group at Warner-Lambert/Pfizer. From 1985 to 1997, he held positions of
increasing responsibility in Finance and Operations at Ciba-Geigy/Novartis.
Robert E. Klem, Ph.D., 59, was Vice President and Chief
Technical Officer at the time of his retirement on January 1, 2003. Since
January 1, 2003, Dr. Klem has been a consultant to Genta. Dr. Klem joined
Genta in February 1991 and was promoted to Vice President in October of
that year. He served as a Genta Director from 1991 until 2000. In 1973,
Dr. Klem co-founded JBL Scientific, Inc., where he also served as Chairman
of the Board. Dr. Klem was previously Plant Manager for E.I. DuPont in
Victoria, Texas from 1970 to 1974.
Betsy McCaughey, Ph.D., 55, has been a member of Gentas
Board of Directors since June 2001. Dr. McCaughey is a nationally recognized
expert on health care. Dr. McCaughey has had a distinguished academic career
as a faculty member at Columbia University and as John M. Olin Fellow at
the Manhattan Institute. In the mid 1990s, she received broad recognition
for her analysis of the Clinton health care plan. In 1995, she was elected
Lieutenant Governor of New York and was a candidate for Governor in 1998.
As Lieutenant Governor, she drafted legislation dealing with Medicaid reform,
clinical trials access, hospital financing and insurance reform. She is
currently an Adjunct Senior Fellow at the Hudson Institute and is a frequent
commentator on the future of the health care industry. Dr. McCaughey has
authored numerous articles on health insurance, medical innovation, government
regulation and public policy, which have appeared in publications such
as The Wall Street Journal, New Republic, The New York
Times, and U.S. News and World Report.
Daniel D. Von Hoff, M.D., F.A.C.P., 56, has been a member
of Gentas Board of Directors since January 2000. He is currently Professor
of Medicine and Professor of Pathology, Molecular and Cellular Biology,
Director of the Arizona Health Science Centers Cancer Therapeutics Program
at The University of Arizona in Tucson. He also serves as Executive Vice
President of the Translational Genomics Research Institute (TGen), and
will also serve as Director of TGens Translational Drug Development Division.
Dr. Von Hoff is also Chief Scientific Officer for US Oncology. From 1985
through 1999, he was a professor at the University of Texas Health Science
Center at San Antonio. From 1994 through 1999, he was also an adjunct scientist
at the Southwest Foundation for Biomedical Research. Dr. Von Hoff has published
more than 503 papers, 126 book chapters and more than 843 abstracts. Dr.
Von Hoff is the former President of the American Association for Cancer
Research, a Fellow of the American College of
42
Physicians
and a member and past board member of the American Society of Clinical
Oncology. He is a founder and board member of ILEX Oncology, Inc. Dr.
Von Hoff has also served as a consultant to a number of biopharmaceutical
companies engaged in oncology drug development. He is founder and the Editor
Emeritus of Investigational New Drugs The Journal of New Anticancer Agents
and Editor of Molecular Cancer Therapeutics. He has played a significant
role in the development of several anticancer agents, e.g. gemcitabine,
CPT-11, docetaxel and others now used routinely in the practice of oncology.
Harlan J. Wakoff, 37, has been a member of Gentas Board
of Directors since September 1997. Mr. Wakoff is a Managing Director in
the Mergers & Acquisitions Group at J.P. Morgan Securities Inc. From
1996 to 1999 Mr. Wakoff was a Vice President of the Media and Entertainment
Investment Banking Group at ING Baring Furman Selz LLC. He was previously
affiliated with the investment banking groups at NatWest Markets from January
1995 to June 1996 and Kidder Peabody & Co. from August 1993 to January
1995.
Douglas G. Watson, 58, has been a member of Gentas Board
of Directors since April 2002. Prior to taking early retirement in 1999,
Mr. Watson spent 33 years with Geigy/Ciba-Geigy/Novartis, during which
time he held a variety of positions in the U.K., Switzerland and the U.S.
From 1986 to 1996, he was President of Ciba US Pharmaceuticals Division,
and in 1996 he was appointed President & CEO of Ciba-Geigy Corporation.
During this ten-year period, Mr. Watson was an active member of the Pharmaceutical
Research & Manufacturers Association board in Washington, DC. Mr. Watson
became President & CEO of Novartis Corporation in 1997 when the merger
of Ciba-Geigy & Sandoz was approved by the Federal Trade Commission.
Mr. Watson is currently Chairman of OraSure Technologies Inc. He also serves
as a director on the boards of Engelhard Corporation and Dendreon Corporation,
as well as a number of privately held biotechnology companies.
Michael S. Weiss, 37, has been Vice Chairman of Gentas
Board of Directors since May 1997 and was appointed Lead Director in November
2002. Mr. Weiss is Chairman and CEO of Keryx Biopharmaceuticals, a drug
development company focused on therapies for cancer and diabetes. Prior
to joining Keryx, from March 1999 to December 2002, Mr. Weiss served
first as Chief Executive Officer and Chairman and then as the Executive
Chairman of ACCESS Oncology, Inc., a private biotechnology company dedicated
to the in-licensing and development of clinical stage oncology drugs. Previously,
from November 1993 to March 1999, Mr. Weiss was Senior Managing Director
of Paramount Capital, Inc., a NASD registered broker-dealer. Prior to that,
Mr. Weiss was an attorney at Cravath, Swaine & Moore.
Bruce A. Williams, 48, Senior Vice President, Sales and
Marketing since February 2001. Mr. Williams served most recently as Vice
President, Sales and Marketing, at Celgene Corporation from July 1996 until
March 2001, where he launched Thalomid(®), that companys first pharmaceutical
product. He was previously Executive Director for Marketing at Ortho Biotech,
Inc., a Johnson & Johnson company, where he launched Procrit(®)
(epoetin alfa). Previously, Mr. Williams held sales, marketing, advertising,
and licensing/acquisition positions at Lederle, now a division of American
Home Products, Inc., and at Organon, Inc.
Patrick J. Zenner, 56, has been a member of Gentas Board
of Directors since December 2001. Mr. Zenner is a 31-year veteran of the
pharmaceutical industry and spent his entire career at Hoffmann-La Roche.
During his first 12 years there, he held positions of increasing responsibility
in sales, marketing, health care economics, public policy and governmental
affairs. In 1982, he became Vice-President and General Manager of Roche
Laboratories, and subsequently Director and Head of Global Pharma Marketing,
Project Development and Regulation in Basel, Switzerland. In 1988, he became
Senior Vice President, Pharmaceuticals Division and a member of the Board
of Directors. From 1993 to his retirement in 2001, he served as President
and CEO of Hoffmann-La Roche Inc., North America. Mr. Zenner currently
serves on the Boards of Geron, Inc., Praecis Pharmaceuticals, Inc., Dendrite
International, Inc, ArQule Inc., First Horizon Pharmaceutical Corp., West
Pharmaceutical Services, CuraGen Corp., Exact Sciences Corp. and Xoma Ltd.
He has also served as a member of the Board and
43
the Executive
Committee of both the Pharmaceutical Research & Manufacturers Association
and the Biotechnology Industry Organization.
Compensation
of Directors
Employee directors of Genta receive no cash compensation for their Board
membership. Non-employee directors of Genta receive $15,000 annual retainer
for their services as directors, $1,500 for each board meeting attended
in person, $750 for each board meeting attended telephonically and $2,500
per day for outside board or committee meeting activities. Non-employee
committee members receive $1,000 per committee meeting attended in person
and $750 per committee meeting attended telephonically. The Lead Director
and each chair of a committee of the Board receive an additional $5,000
annual retainer. Non-employee directors are also reimbursed by Genta for
their out-of-pocket expenses incurred in attending meetings of the Board
of Directors and its committees. In addition, under our Amended Non-Employee
Directors 1998 Stock Option Plan, non-employee directors currently receive
a grant of 24,000 stock options upon their initial election to the Board
and, thereafter, each member of the Board will receive an annual grant
of 20,000 stock options at the first Board of Directors meeting they attend
in person each year. Pending approval of an Amended Non-Employee Directors
1998 Stock Option Plan by stockholders at the next annual meeting, the
Lead Director and each chair of a committee of the Board receive an additional
annual grant of 5,000 stock options. Employee directors are eligible for
stock options under our 1998 Stock Incentive Plan.
Executive Compensation
Summary Compensation Table |
The following table sets forth certain information regarding compensation paid to our Chief Executive Officer and the four other most highly paid executive officers during the year ended December 31, 2002.
Annual Compensation | Long-Term Compensation Awards | ||||||||||||
|
|
||||||||||||
Name and Principal Position | Year | Salary ($) | Bonus ($) | Other
Annual
Compensation |
Securities
Underlying Options (#) |
||||||||
|
|
|
|
|
|
||||||||
Raymond P. Warrell, Jr., M.D. | 2002 | $ | 325,000 | $ | 200,000 | $ | 16,289 | (1) | 300,000 | (2) | |||
Chairman, and | 2001 | 325,000 | 100,000 | 18,037 | 300,000 | ||||||||
Chief Executive Officer | 2000 | 325,000 | 100,000 | 18,144 | | ||||||||
William P. Keane | 2002 | 47,333 | (3) | 65,000 | | 100,000 | (4) | ||||||
Vice President, | |||||||||||||
Chief Financial Officer and | |||||||||||||
Corporate Secretary | |||||||||||||
Loretta M. Itri, M.D. | 2002 | 307,000 | 107,200 | 3,464 | (5) | 40,000 | (6) | ||||||
President, Pharmaceutical | 2001 | 201,807 | 79,500 | 11,179 | 300,000 | ||||||||
Development and Chief | |||||||||||||
Medical Officer | |||||||||||||
Bruce A. Williams | 2002 | 203,200 | 50,800 | | 35,000 | (7) | |||||||
Senior Vice President, | 2001 | 161,125 | 39,000 | | 150,000 | ||||||||
Sales and Marketing | |||||||||||||
Robert E. Klem, Ph.D. | 2002 | 214,300 | 42,900 | 5,848 | (8) | 15,000 | (9) | ||||||
Vice President and | 2001 | 204,000 | 24,700 | | | ||||||||
Chief Technical Officer |
(1) | Includes $6,000 for auto allowance and $10,289 for life insurance. |
(2) | Represents 300,000 options approved by the Board of Directors in January 2002 for milestones achieved in the year 2001 and excludes 300,000 options approved by the Compensation Committee of the Board of Directors in January 2003 as part of 2002 annual bonus. |
(3) | Mr. Keane, who was hired in 2002, receives a base salary of $260,000 per annum, which was prorated during 2002. |
(4) | Represents options issued upon employment. |
(5) | Represents long-term disability insurance. |
44
(6) | Represents 40,000 options approved in January 2002 as part of 2001 annual bonus and excludes 30,000 options approved in January 2003 as part of 2002 annual bonus. |
(7) | Represents options approved in January 2002 as part of 2001 annual bonus and excludes 20,000 options approved in January 2003 as part of 2002 annual bonus. |
(8) | Represents travel allowance. |
(9) | Represents options approved in January 2002 as part of 2001 annual bonus. Dr. Klem retired from Genta on January 1, 2003, and these 15,000 options were cancelled upon his retirement from Genta. |
Stock Options |
The following table sets forth certain information concerning grants of stock options made during 2002 to our Chief Executive Officer and the four other most highly paid executive officers during the year ended December 31, 2002.
Option Grants in Last Fiscal Year |
Number Of | Percent Of | |||||
Securities | Total Options | |||||
Underlying | Granted To | Grant Date | ||||
Options | Employees In | Exercise Price | Expiration | Present | ||
Name | Granted | Fiscal Year | ($/Share) | Date | Value (1) | |
|
|
|
|
|
|
|
Raymond P. Warrell, Jr., M.D. | 300,000(2) | 23.5% | $13.70 | Jan. 25, 2012 | $ 2,102,187 | |
William P. Keane | 100,000(3) | 7.9% | 7.38 | Oct. 28, 2012 | 377,473 | |
Loretta M. Itri, M.D. | 40,000(4) | 3.1% | 13.70 | Jan. 25, 2012 | 280,292 | |
Bruce A. Williams | 35,000(5) | 2.8% | 13.70 | Jan. 25, 2012 | 245,255 | |
Robert E. Klem, Ph.D. | 15,000(6) | 1.2% | 13.70 | N/A (6) | N/A (6) |
(1) | These amounts represent the estimated fair value of stock options, measured at the date of grant using the Black-Scholes option-pricing model. There are four underlying assumptions in developing the grant valuations: an expected volatility of 65%, an expected term of exercise of four years, a range of risk free interest rates of 2.8% and a dividend yield of 0%. The actual value, if any, an officer may realize will depend on the amount by which the stock price exceeds the exercise price on the date the option is exercised. Consequently, there is no assurance the value realized by an officer will be at or near the value estimated above. These amounts should not be used to predict stock performance. |
(2) | Represents options approved by the Compensation Committee of the Board of Directors in January 2002 for milestones achieved in the year 2001 and excludes 300,000 options approved by the Compensation Committee of the Board of Directors in January 2003 as part of 2002 annual bonus. |
(3) | Represents options issued upon employment. |
(4) | Represents options approved in January 2002 as part of 2001 annual bonus and excludes 30,000 options approved in January 2003 as part of 2002 annual bonus. |
(5) | Represents options approved in January 2002 as part of 2001 annual bonus and excludes 20,000 options approved in January 2003 as part of 2002 annual bonus. |
(6) | Represents options approved in January 2002 as part of 2001 annual bonus that were cancelled upon Dr. Klems retirement from Genta. |
Option Exercises in Last Fiscal Year and Fiscal Year End Option Values |
The following table sets forth certain information with respect to aggregate
option exercises in the fiscal year ended December 31, 2002 by our Chief
Executive Officer and the four other most highly paid executive officers
during the year ended December 31, 2002, and with respect to the unexercised
options as of December 31, 2002 held by our Chief Executive Officer and
the four other most highly paid executive officers during the year ended
December 31, 2002:
45
Number of Securities | Value of Unexercised | |||||||||||
Underlying Unexercised | In-The-Money Options | |||||||||||
Options at Fiscal Year End | at Fiscal Year End (1) | |||||||||||
|
|
|||||||||||
Shares | ||||||||||||
Acquired | Value | |||||||||||
Name | On Exercise | Realized | Exercisable | Unexercisable | Exercisable | Unexercisable | ||||||
|
|
|
|
|
|
|
||||||
Raymond P. Warrell, Jr., M.D. | | | 4,119,385 | 1,243,877 | $19,930,679 | $3,986,136 | ||||||
William P. Keane | | | | 100,000 | | 31,000 | ||||||
Loretta M. Itri, M.D. | | | 60,000 | 280,000 | 117,600 | 470,400 | ||||||
Bruce A. Williams | | | 37,500 | 147,500 | 38,775 | 116,325 | ||||||
Robert E. Klem, Ph.D. | 65,000 | $807,407 | 557,353 | 25,000 | 3,669,960 | |
(1) | Calculated on the basis of the market value of the underlying securities as of December 31, 2002 ($7.69 per share), minus the exercise price, and excludes options approved in January 2003 as part of 2002 annual bonus. |
Equity Compensation Plan Information
Number of securities | ||||||
remaining available | ||||||
for future issuance | ||||||
Number of securities | under equity | |||||
to be issued upon | Weighted-average | compensation plans | ||||
exercise of | exercise price of | (excluding securities | ||||
outstanding options, | outstanding options, | reflected in the first | ||||
Plan category | warrants and rights | warrants and rights | column) | |||
|
|
|
|
|||
Equity compensation plans approved by | ||||||
security holders | 9,368,336 | $5.13 | 4,817,519 | |||
Equity compensation plans not approved | ||||||
by security holders (1) | - | - | - |
(1) | None. |
Employment
and Consulting Agreements
Pursuant to an employment agreement dated as of December 1, 2002 between
Genta and Dr. Warrell and signed May 16, 2003, Dr. Warrell continues to
serve as Chairman and Chief Executive Officer of Genta. Dr. Warrells 2003
employment agreement will expire on December 31, 2005. Under his 2003 employment
agreement, Dr. Warrell receives a base salary of $400,000 per annum with
annual percentage increases equal to at least the Consumer Price Index
for the calendar year preceding the year of the increase. In the event
Genta terminates his employment without cause (as defined in the 2003 Agreement)
or Dr. Warrell terminates his employment for good reason (as defined in
the 2003 Agreement), Dr. Warrell becomes entitled to receive, as severance,
the base salary he would have received during the twelve-month period following
the date of termination. At the end of each calendar year, Dr. Warrell
is eligible for an annual bonus ranging from 0% to 60% of annual base salary,
subject to the achievement of agreed-upon goals and objectives. Dr. Warrell
is entitled to receive (i) an initial option grant of 1,000,000 stock options,
of which (a) 500,000 shares should vest immediately in the event that the
average share price exceeds $20.00 for seven consecutive trading days and
(b) the remaining 500,000 shares should vest immediately in the event that
the average share price exceeds $30.00 for seven consecutive trading days;
(ii) annual stock options for the purchase of up to 225,000 shares of common
stock, depending upon the achievement of agreed-upon goals and objectives.
Dr. Warrell continues to be entitled to any and all medical insurance,
dental insurance, group health, disability insurance and other benefit
plans, which are generally available to Gentas senior executives.
Pursuant to an employment agreement dated as of August 5, 2003, between
Genta and Dr. Itri, Dr. Itri was appointed President, Pharmaceutical Development,
and Chief Medical Officer of Genta as of March 28, 2003. The employment
agreement has an initial term of three years, beginning March 28, 2003
and continuing through March 27, 2006. The agreement provides for a base
annual salary of
46
$400,000, and
an annual cash bonus ranging from 0% to 50% of her base salary to be paid
if mutually agreed-upon goals and objectives are achieved for the year.
Dr. Itri was also granted an incentive stock option to purchase 300,000
shares of Gentas common stock at an exercise price of $11.95 per share,
one third of the shares to become exercisable upon the first FDA approval
of Genasense, one third of the shares to become exercisable upon FDA approval
of Genasense in any second indication, and one third of the shares to become
exercisable upon FDA approval of Genasense in any of the following indications:
non-small cell lung cancer, breast, colorectal, prostate or non-Hodgkins
Lymphoma.
Pursuant to a consultancy agreement dated as of December 13, 2002 between
Genta and Dr. Klem, Dr. Klems services were retained for a term of one
year through December 31, 2003. The consultancy agreement provides for
fixed monthly payments in the aggregate of $99,000, in addition to travel
reimbursements.
Compensation
Committee Interlocks and Insider Participation
None of the members of the Compensation Committee had any interlock relationship
to report during our fiscal year ended December 31, 2002.
47
RELATIONSHIPS AND RELATED TRANSACTIONS
Michael S. Weiss, Vice Chairman of Gentas board of directors, is a managing
director of Genta Jago Technologies, B.V., a joint venture that is 50%
owned by Genta.
J.P. Morgan Securities Inc., of which our director Harlan J. Wakoff is
a Managing Director, provided advice to us in 2002 on our collaborative
agreements with Aventis. Mr. Wakoff did not participate in the decision
to engage J.P. Morgan Securities Inc. in connection with the collaborative
agreements.
48
PRINCIPAL AND SELLING STOCKHOLDERS
The selling stockholders are offering and selling a total of 671,412
shares of Genta common stock under this prospectus. The shares being offered
under this prospectus were originally issued to the selling stockholders
in connection with Gentas acquisition of Salus Therapeutics, Inc. in August
2003. In connection with this acquisition, we agreed to register these
shares under the Securities Act.
The following table sets forth, to the best of our knowledge, based on information provided to us by the selling stockholders:
| the number of shares of Genta common stock owned by each selling stockholder; and |
| the number of shares being offered by each selling stockholder under this prospectus. |
All information with respect to share ownership has been provided by the
selling stockholders. Except as described below, none of the selling stockholders
holds any position or office with, or has otherwise had a material relationship
with, Genta for the past three years. Since the date on which the selling
stockholders provided this information, they may have sold, transferred
or otherwise disposed of all or a portion of their shares of common stock
in transactions exempt from the registration requirements of the Securities
Act.
None of the selling stockholders beneficially owns 1% or more of our outstanding
common stock.
The selling stockholders will determine the actual number of shares, if any, that they will sell. Because the selling stockholders may sell all, some or none of the shares of common stock that they hold and offer, we are unable to estimate the amount or percentage of shares of common stock that they will hold after completion of the offering.
Number of Shares of Common | Number of Shares of Common | |||
Name | Stock Beneficially Owned (1) | Stock Being Offered | ||
Thomas N. Parks | 5,297 | 3,443 | Dinesh Patel(2) | 28,183 | 18,319 |
Ramesh Prakash, Ph.D.(3) | 18,089 | 11,758 | ||
Paradigm Resources, L.C. | 17,142 | 11,142 | ||
Duane E. Ruffner(4) | 28,658 | 18,319 | ||
Willem Spiegel | 2,759 | 1,832 | ||
University of Utah Research Foundation(5) | 7,864 | 5,112 | ||
Utah Ventures II, L.P. | 680,432 | 442,281 | vSpring, L.P. | 170,350 | 110,731 | vSpring Partners, L.P. | 21,701 | 14,106 |
WS Investment Company, LLC | 5,297 | 3,443 | ||
Other Selling Stockholders | 46,153 | 30,926 | ||
Total | 1,031,925 | 671,412 | ||
(1) | Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. |
(2) | By virtue of his position as Managing Director of the general partner of vSpring, L.P. and vSpring Partners, L.P. Mr. Patel may be considered the beneficial owner of 170,350 shares of common stock held by, and 110,731 shares of common stock being offered by, vSpring, L.P. and 21,701 shares held by, and 14,106 shares of common stock being offered by, vSpring Partners, L.P. |
(3) | From August 21, 2003 to September 25, 2003, Mr. Prakash was an employee of Genta. |
(4) | Since August 21, 2003, Mr. Ruffner has been an employee of Genta. |
(5) | The University of Utah Research Foundation is the licensor of certain technology to Genta. |
The following table sets forth as of October 15, 2003 certain information with respect to the beneficial ownership of common stock of:
| each of our directors; |
| each of our Chief Executive Officer and the four other most highly paid executive officers during the year ended December 31, 2002; and |
| each person known to us to own beneficially five percent or more of our outstanding common stock |
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As of October 15, 2003, each share of series A convertible preferred stock was convertible at the option of the holder into approximately 6.8334 shares of common stock. Except as required by law or with respect to the creation or amendment of senior classes of preferred stock or creation of different series or classes of common stock, and in certain other instances, the holders of series A convertible preferred stock do not have voting rights until such shares are converted into common stock. The conversion price and the numbers of shares of common stock issuable upon conversion of the series A convertible preferred stock may be adjusted in the future, based on the provisions in our restated certificate of incorporation, as amended.
Number of Shares of | Percent of Class of | ||
Common Stock | Common Stock | ||
Name and Address (1) | Beneficially Owned (2) | Beneficially Owned (3) | |
|
|
|
|
Raymond P. Warrell, Jr., M.D. | 4,260,185 (4) | 5.3% | |
William P. Keane | 31,000 (5) | * | |
Loretta M. Itri, M.D. | 146,995 (6) | * | |
Bruce A. Williams | 92,750 (7) | * | |
Robert E. Klem, Ph.D. | 104,353 (8) | * | |
Jerome E. Groopman, M.D. | 28,000 (9) | * | |
Betsy McCaughey, Ph.D. | 69,334 (9) | * | |
Daniel D. Von Hoff, M.D. | 121,667 (9) | * | |
Harlan J. Wakoff | 237,500 (9) | * | |
Douglas G. Watson | 63,000 (10) | * | |
Michael S. Weiss | 837,272 (11) | 1.1% | |
Patrick J. Zenner | 48,000 (9) | * | |
Lindsay A. Rosenwald, M.D. | |||
787 Seventh Avenue | |||
New York, NY 10019 | 23,183,944 (12) | 28.6% | |
Garliston Limited | |||
c/o Aventis Pharmaceuticals Inc. | |||
300 Somerset Corporate Blvd. | |||
Bridgewater, NJ 08807 | 6,665,498 (13) | 8.8% | |
All Directors and Executive Officers as a group | 6,040,056 (14) | 7.4% |
* | Less than one percent (1%). |
(1) | Unless otherwise indicated, the address of each named holder is c/o Genta Incorporated, Two Connell Drive, Berkeley Heights, NJ 07922. |
(2) | Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. Shares of common stock subject to options exercisable within 60 days of October 15, 2003 are deemed outstanding for computing the percentage of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Except as indicated by footnote, and subject to community property laws where applicable, the person named in the table has sole voting and investment power with respect to all shares of common stock shown as beneficially owned by them. |
(3) | Based on 76,263,984 shares of common stock outstanding as of October 15, 2003. |
(4) | Consists of 50,800 shares of common stock, 10,000 shares of common stock related to the asset purchase agreement with Relgen LLC, a privately held corporation, of which Dr. Warrell is the majority stockholder, 5,000 shares held by Dr. Warrells childs custodial account and 4,194,385 shares of common stock issuable upon exercise of currently exercisable stock options. Excludes 15,995 shares of common stock held by Dr. Warrells wife, Dr. Itri, issued as a hiring bonus and 1,000 shares of common stock held by Dr. Itris individual retirement account. Dr. Warrell disclaims beneficial ownership of such shares. |
50
(5) | Consists of 6,000 shares of common stock and 25,000 shares of common stock issuable upon exercise of currently exercisable stock options. |
(6) | Consists of 16,995 shares of common stock and 130,000 shares of common stock issuable upon exercise of currently exercisable stock options. Excludes 10,000 shares held by a privately held corporation, of which Dr. Itris husband, Dr. Warrell, is the majority stockholder, 50,800 shares of common stock held by Dr. Warrells Individual Retirement Account and 5,000 shares held by Dr. Warrells childs custodial account. Dr. Itri disclaims beneficial ownership of such shares. |
(7) | Consists of 9,000 shares of common stock and 83,750 shares of common stock issuable upon exercise of currently exercisable stock options. |
(8) | Consists of 104,353 shares of common stock issuable upon exercise of currently exercisable stock options and excludes 12,000 shares held by Dr. Klems childrens individual retirement accounts. |
(9) | Consists of shares issuable upon exercise of currently exercisable stock options. |
(10) | Consists of 15,000 shares of common stock and 48,000 shares of common stock issuable upon exercise of currently exercisable stock options. |
(11) | Consists of 601,438 shares of common stock, and 235,834 shares of common stock issuable upon exercise of currently exercisable stock options. |
(12) | Dr. Rosenwald may be deemed to have shared voting and investment power over the 17,936,016 shares of common stock and 250,800 shares of series A convertible preferred stock (which are convertible into 1,713,817 shares of common stock) that may be deemed to be beneficially owned by Paramount Capital Asset Management, Inc., or Paramount, of which Dr. Rosenwald is the sole stockholder. Paramount Capital Asset Management, Inc. may be deemed to have shared voting and investment power over: (i) 2,261,680 shares of common stock held by Aries Select I, LLC, (ii) 4,729,299 shares of common stock held by Aries Select Limited, a Cayman Islands trust, (iii) 513,546 shares of common stock held by Aries Select II, LLC, (iv) 5,797,807 shares of common stock held by Aries Master Fund II, LP, (v) 4,047,582 shares of common stock held by Aries Domestic Fund, LP, (vi) 586,102 shares of common stock held by Aries Domestic Fund II, LP, (vii) 76,813 shares of series A convertible preferred stock (convertible into 528,735 shares of common stock) held by Aries Select I, LLC, (viii) 158,081 shares of series A convertible preferred stock (convertible into 1,080,231 shares of common stock) held by Aries Select Limited, (ix) 15,906 shares of series A convertible preferred stock (convertible into 108,692 shares of common stock) held by Aries Select II, LLC. Paramount Capital Asset Management Inc. is the General Partner and Investment Advisor of Aries Select Fund I and Aries Select Fund II and the Investment Advisor of Aries Limited. |
In addition, Dr. Rosenwalds holdings include 15,000 shares of common stock and 3,519,117 shares of common stock issuable upon exercise of currently exercisable warrants, over which Dr. Rosenwald may be deemed to have sole voting and investment power. Such warrants consist of 3,261,896 shares of common stock issuable upon conversion of 25.83 unit purchase options relating to warrants issued in June 1997, 68,500 shares of common stock issuable upon exercise of certain warrants issued in August 1999, 158,683 shares of common stock issuable upon exercise of certain warrants issued in December 1999 and 30,038 shares of common stock issuable upon exercise of certain warrants issued in December 2001. |
(13) | Aventis Pharmaceuticals Inc. may be deemed to have shared voting and investment power over 6,665,498 shares of common stock held by Garliston Limited. These shares were issued to Garliston Limited in connection with our collaborative agreements with Aventis. |
(14) | Consists of 714,233 shares of common stock and 5,325,823 shares of common stock issuable upon exercise of currently exercisable stock options. |
51
DESCRIPTION OF CAPITAL STOCK
Our authorized capital stock consists of 120,000,000 shares of common stock,
par value $0.001 per share, and 5,000,000 shares of preferred stock, par
value $0.001 per share.
The following descriptions are summaries of the material terms of our restated
certificate of incorporation and bylaws. Reference is made to the more
detailed provisions of, and the descriptions are qualified in their entirety
by reference to, the restated certificate of incorporation and bylaws,
copies of which are filed with the SEC as exhibits to the registration
statement of which this prospectus is a part, and applicable law.
General
The authorized capital stock of Genta consists of 120,000,000 shares of
common stock and 5,000,000 shares of preferred stock.
Common Stock
As of October 15, 2003, there were 76,263,984 shares of common stock outstanding.
Except as required by law or by the restated certificate of incorporation,
holders of common stock are entitled to one vote for each share held of
record on all matters submitted to a vote of the stockholders. Subject
to preferences that may be applicable to any then outstanding preferred
stock, holders of common stock are entitled to receive ratably such dividends
as may be declared by the Board of Directors out of funds legally available
therefor. See Dividend Policy. In the event of a liquidation, dissolution
or winding up of Genta, holders of the common stock and the preferred stock
are entitled to share ratably on an as-converted basis in all assets remaining
after payment of liabilities and the liquidation preference of any then
outstanding preferred stock. Holders of common stock have no right to convert
their common stock into any other securities. There are no redemption or
sinking fund provisions applicable to the common stock. All outstanding
shares of common stock are fully paid and non-assessable.
Preferred
Stock
The Board of Directors has the authority, without further action by the
stockholders, to issue up to 5,000,000 shares of preferred stock in one
or more series and to fix the rights, preferences, privileges and restrictions
thereof, including dividend rights, conversion rights, voting rights, terms
of redemption, liquidation preferences and the number of shares constituting
any series or the designation of such series. The issuance of preferred
stock could adversely affect the voting power of holders of common stock
and could have the effect of delaying, deferring or preventing a change
in control of Genta without further action by the stockholders and may
adversely affect the voting and other rights of the holders of our common
stock.
Rights Agreement
On December 16, 1993, our board of directors declared a dividend distribution of one share purchase right for each outstanding share of our common stock. The description and terms of the rights are set forth in a Rights Agreement between Genta and First Interstate Bank of California, as rights agent, as amended in 1997.
Anti-takeover Effects |
The rights may have anti-takeover effects. If the rights become exercisable,
the rights will cause substantial dilution to a person or group that attempts
to acquire or merge with us in most cases. Accordingly, the existence of
the rights may deter a potential acquiror from making a takeover proposal
or tender offer. The rights should not interfere with any merger or other
business combination approved by our board of directors since we may redeem
the rights as described below and since a transaction approved by our board
of directors would not cause the rights to become exercisable.
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Exercisability of Rights |
The rights attach to all our common stock certificates representing shares
then outstanding, and no separate rights certificates are distributed.
Except as set forth below, each right, when exercisable, entitles the registered
holder to purchase from Genta one one-thousandth share of a new series
of preferred stock, designated as Series F Participating Preferred Stock,
$0.001 par value, at a price of $50.00 per share, subject to adjustment.
For the purposes of the rights agreement, an acquiring person is a person
or group besides our company, Lindsay Rosenwald and the Paramount and Aries
entities, prior to the distribution, who has acquired
or obtained the rights to acquire beneficial ownership of 15% or more of
the voting power of all our outstanding voting securities.
The rights will separate from the common stock and a distribution date will occur upon the earlier of:
| a public announcement that a person or group of affiliated or associated persons has become an acquiring person; or |
| 10 days (unless that date is extended by our board of directors) following the commencement of (or a public announcement of an intention to make) a tender offer or exchange offer which would result in any person or group of related persons becoming an acquiring person. |
The rights are not exercisable until the distribution date.
Flip Over Feature |
In the event that, after the first date of public announcement by Genta or an acquiring person that there is an acquiring person, Genta is involved in a merger or other business combination transaction (whether or not Genta is the surviving corporation) or 50% or more of Gentas assets or earning power are sold (in one transaction or a series of transactions), each holder of a right, except for the acquiring person, shall have the right to receive, upon the exercise of the right, at the then current exercise price of the right, the number of shares of common stock of the acquiring companys capital stock having a value equal to twice the exercise price of the right. This right is referred to as the merger right.
Flip In Feature |
In the event that a person becomes an acquiring person (unless through
a permitted offer, which is an offer that is pursuant to a tender offer
or exchange offer for all outstanding shares of our common stock at a price
and on terms determined prior to the date of the first acceptance of payment
for any of these shares by at least a majority of the members of our board
of directors who are not officers of Genta and are not acquiring persons
or affiliates or associates thereof to be both adequate and otherwise in
the best interests of Genta and our stockholders), each holder of a right
will for a 60-day period (subject to extension under some circumstances)
thereafter have a right to receive upon exercise shares of common stock,
as the case may be, having a market value of two times the exercise price
of the right, to the extent available, and then (after all authorized and
unreserved shares of common stock have been issued) a common stock equivalent
(such as preferred stock or another equity security with at least the same
economic value as the common stock) having a market value of two times
the exercise price of the right, with common stock to the extent available
being issued first. This right is referred to as the subscription right.
The holder of a right will continue to have the merger right whether or not that holder exercises the subscription right. Notwithstanding the foregoing, upon the occurrence of any of the events giving rise to the exercisability of the merger right or the subscription right, any rights that are or were at any time after the distribution date owned by an acquiring person shall immediately become null and void.
Exchange Feature |
Subject to applicable law, our board of directors, at its option, may at
any time after a person becomes an acquiring person (but not after the
acquisition by that person of 50% or more of the
53
outstanding common stock), exchange all or part of the then outstanding and exercisable rights (except for rights which have become void) for shares of common stock equivalent to one share of common stock per right or, alternatively, for substitute consideration consisting of cash, securities of Genta or other assets (or any combination thereof).
Redemption of Rights |
At any time prior to the earlier to occur of:
| a person becoming an acquiring person or |
| the expiration of the rights, |
Genta may redeem the rights in whole, but not in part, at a redemption price of $.01 per right, which redemption shall be effective upon the action of our board of directors. Additionally, Genta may thereafter redeem the then outstanding rights in whole, but not in part, at the redemption price:
| if that redemption is incidental to a merger or other business combination transaction or series of transactions involving Genta but not involving an acquiring person or related persons, or |
| following an event giving rise to, and the expiration of the exercise period for, the subscription right if and for as long as an acquiring person beneficially owns securities representing less than 15% of the voting power of Gentas voting securities. |
These redemption of rights shall be effective only as of that time when the subscription right is not exercisable, and in any event, only after ten business days prior notice. Upon the effective date of the redemption of the rights, the right to exercise the rights will terminate and the only right of the holders of rights will be to receive the redemption price.
Adjustment of Rights |
The purchase price payable, and the number of shares of preferred stock or other securities or property issuable, upon exercise of the rights are subject to adjustment from time to time to prevent dilution:
| in the event of a stock dividend on, or a subdivision, combination or reclassification of the preferred stock; |
| upon the grant to holders of the preferred stock of particular rights or warrants to subscribe for preferred stock, convertible securities or securities having the same or more favorable rights, privileges and preferences as the preferred stock at less than the current market price of the preferred stock; or |
| upon the distribution to holders of the preferred stock of evidences of indebtedness or assets (excluding regular quarterly cash dividends out of earnings or retained earnings) or of subscription rights or warrants (other than those referred to above). |
With some exceptions, no adjustments in the purchase price will be required until cumulative adjustments require an adjustment of at least 1% in that purchase price. No fractions of shares will be issued and, in lieu thereof, an adjustment in cash will be made based on the market price of the common stock on the last trading date prior to the date of exercise.
Termination of Rights |
The rights will expire on the earliest of:
| December 16, 2003; |
54
| consummation of a merger transaction with a person or group who acquired common stock pursuant to a permitted offer, and is offering in the merger the same price per share and form of consideration paid in the permitted offer; or |
| redemption by Genta as described under Redemption of Rights. |
Series F Participating Preferred Stock |
Each share of the Series F Participating Preferred Stock that is purchasable upon exercise of the rights will be:
| nonredeemable and junior to any other series of preferred stock Genta may issue (unless otherwise provided in the terms of that stock); |
| will have a preferential quarterly dividend in an amount equal to 1,000 times the dividend declared on each share of common stock, but in no event less than $100; |
| in the event of liquidation, the holders of preferred stock will receive a preferred liquidation payment equal to the greater of 1,000 times $1.00 or 1,000 times the payment made per each share of common stock; |
| will have 1,000 votes, voting together with the shares of common stock; and |
| in the event of any merger, consolidation or other transaction in which shares of common stock are exchanged, each share of preferred stock will be entitled to receive 1,000 times the amount and type of consideration received per share of common stock. |
The rights of our preferred stock as to dividends, liquidation and voting,
and in the event of mergers and consolidations, are protected by customary
antidilution provisions. Fractional shares of preferred stock will be issuable;
however, Genta may elect to distribute depositary receipts in lieu of those
fractional shares. In lieu of fractional shares other than fractions that
are multiples of one one-thousandth of a share, an adjustment in cash will
be made based on the market price of the preferred stock on the last trading
date prior to the date of exercise.
Until a right is exercised, the holder thereof, as such, will have no rights
as a stockholder of Genta, including, without limitation, the right to
vote or to receive dividends.
Series A Convertible Preferred Stock
General |
We are authorized to issue 600,000 shares of series A convertible preferred
stock. As of June 30, 2003, 260,500 shares are issued and outstanding.
Each share of series A convertible preferred stock is immediately convertible,
into shares of our common stock, at a rate determined by dividing the aggregate
liquidation preference of the series A convertible preferred stock by the
conversion price. The conversion price is subject to adjustment for antidilution.
As of October 15, 2003, each share of series A convertible preferred stock
was convertible into 6.8334 shares of our common stock.
In the event of a liquidation of Genta, the holders of series A convertible
preferred stock are entitled to a liquidation preference equal to $50 per
share, or $13.025 million at June 30, 2003.
Options, Warrants and Convertible Securities
As of October 15, 2003, we had options, warrants, convertible preferred stock and convertible debt outstanding exercisable for or convertible into 18,474,636 additional shares.
55
Delaware
Anti-Takeover Law
Under Section 203 of the Delaware General Corporation Law certain business combinations between a Delaware corporation, whose stock generally is publicly traded or held of record by more than 2,000 stockholders, and an interested stockholder are prohibited for a three-year period following the date that such stockholder became an interested stockholder, unless
| the corporation has elected in its certificate of incorporation not to be governed by Section 203 (we have not made such an election); |
| the business combination was approved by the board of directors of the corporation before the other party to the business combination became an interested stockholder; |
| upon consummation of the transaction that made it an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the commencement of the transaction (excluding voting stock owned by directors who are also officers or held in employee benefit plans in which the employees do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
| on or subsequent to such date the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder. The three-year prohibition also does not apply to certain business combinations proposed by an interested stockholder following the announcement or notification of certain extraordinary transactions involving the corporation and a person who had not been an interested stockholder during the previous three years or who became an interested stockholder with the approval of a majority of the corporations directors. A business combination is defined to include mergers, asset sales and other transactions resulting in financial benefit to a stockholder. In general, an interested stockholder is a person who, together with affiliates and associates, owns (or within three years, did own) 15% or more of a corporations voting stock. The statute could prohibit or delay mergers or other takeover or change in control attempts with respect to Genta and, accordingly, may discourage attempts to acquire Genta even though such a transaction may offer Gentas stockholders the opportunity to sell their stock at a price above the prevailing market price. |
Advance
Notice Requirements for Stockholder Proposals
The bylaws provide that stockholders seeking to bring business before an
annual meeting of stockholders, or to nominate candidates for election
as directors at an annual meeting of stockholders, must provide timely
notice thereof in writing. To be timely, a stockholders notice must be
delivered to the secretary at our principal executive offices not less
than 50 calendar days nor more than 75 calendar days prior to the meeting;
provided, that if less than 65 days notice or prior public disclosure
of the date of the meeting is given or made to stockholders, notice by
the stockholder to be timely must be received not later than the close
of business on the 15th day following the day on which notice
of the date of the annual meeting was mailed or such public disclosure
was made. The bylaws also specify requirements as to the form and content
of a stockholders notice. These provisions may discourage stockholders
from bringing matters before an annual meeting of stockholders or from making
nominations for directors at an annual meeting of stockholders.
Limits on
Special Meetings
Gentas bylaws provide that special meetings of the stockholders of Genta
may be called only by the Chairman of the Board or the Chief Executive
Officer of Genta or by a resolution adopted by the affirmative vote of
a majority of the Board of Directors.
56
Listing
Our common stock is listed on the Nasdaq National Market under the symbol
GNTA.
Transfer
Agent and Registrar
The Transfer Agent and Registrar for the common stock is Mellon Investor
Services.
57
COMMON STOCK ELIGIBLE FOR FUTURE SALE
All of the 671,412 shares of our common stock sold in the public market in
this offering will be eligible for immediate resale in the public market without
restriction, except for any of those shares that are beneficially owned at any
time by our affiliates, as defined in Rule 144 of the Securities Act, which
sales will be subject to the timing, volume and manner of sale limitations of
Rule 144.
In general, under Rule 144 as currently in effect, each of our affiliates
will be entitled to sell, without registration, within any three-month
period, a number of shares that does not exceed the greater of 1% of the
then outstanding shares of our common stock, or the average weekly trading
volume of our common stock during the four calendar weeks preceding such
sale. Sales under Rule 144 are also subject to certain provisions regarding
the manner of sale, notice requirements and the availability of current
public information about us.
As of October 15, 2003, there were 4,299,633 shares of common stock available
for grant of options and other stock-based awards under our compensation
plans, and options for 10,989,268 shares of common stock are outstanding.
These shares have been or will be registered on Form S-8 and will be eligible
for sale in the public markets, subject to Rule 144 limitations applicable
to affiliates.
In addition to the shares covered by this registration statement, we have
agreed to register
any shares
beneficially owned by the selling
stockholders and not covered by this registration statement upon
expiration of the escrow agreement relating to them, as well as
shares issued to former Salus stockholders as a result of the occurrence of a
milestone as specified in the merger agreement.
These milestone payments may aggregate to as much as $17.0 million of our
common stock. These stockholders are also entitled, subject to certain
restrictions, to have these shares included in any registered public offering
of common stock by Genta.
Aventis (and any of its permitted assignees), as the holder of 6,665,498
shares of common stock issued as part of the collaborative agreement entered
into between Genta and Aventis in April 2002, may require Genta to register these shares
within 90 days after making a written request at any time after April 2004.
In addition, in the event that Genta has converted any portion of the $10.0
million convertible note issued to Aventis as part of the collaborative
agreement, Genta is required to file a registration statement within 90
days after a written request has been made by Aventis. Aventis is also
entitled, subject to certain restrictions, to have these shares included
in any registered public offering of common stock by Genta after April
2004. The foregoing registration rights terminate when all these shares
been sold by or may be sold without registration pursuant to the exemptions
provided by Rule 144(k) under the Securities Act.
58
PLAN OF DISTRIBUTION
We are registering the shares of Genta common stock offered under this
prospectus on behalf of the selling stockholders. As used herein, selling
stockholders includes donees and pledgees selling shares received from
the selling stockholders after the date of this prospectus. We will pay
all expenses of registration of the shares offered hereby, other than commissions,
discounts and concessions of underwriters, dealers or agents. Brokerage
commissions and similar selling expenses, if any, attributable to the sale
of the shares will be borne by the selling stockholders. We will not receive
any of the proceeds from the sale of the shares by the selling stockholders.
The shares may be sold from time to time by the selling stockholders.
The selling stockholders may from time to time sell their
shares directly to purchasers or, alternatively, through underwriters,
broker-dealers or agents. These shares may be sold in one or more transactions
at fixed prices, at prevailing market prices at the time of sale, at varying
prices determined at the time of sale, or at negotiated prices. Such sales
may be effected in transactions (which may involve crosses or block transactions)
(a) on any national securities exchange or quotation service on which these
shares may be listed or quoted at the time of sale, (b) in the over-the-counter
market, (c) in transactions otherwise than on such exchanges or services
or in the over-the-counter market or (d) through the writing of options.
In connection with sales of these shares or otherwise, the selling stockholders
may enter into hedging transactions with broker-dealers, which may in turn
engage in short sales of these shares in the course of hedging the positions
they assume. The selling stockholders may also sell their shares short
and deliver their shares to close out such short positions, or loan or
pledge their shares to broker-dealers that in turn may sell such securities.
If the selling stockholders effect these transactions by selling their
shares through broker-dealers (which may act as agents or principals),
these broker-dealers may receive compensation in the form of discounts,
concessions or commissions from the selling stockholders and/or the purchasers
of shares for whom these broker-dealers may act as agents or to whom they
sell as principal, or both (which compensation as to a particular broker-dealer
might be in excess of customary commissions).
The selling stockholders and any broker-dealers that act in connection
with the sale of the shares might be deemed to be underwriters within
the meaning of Section 2(11) of the Securities Act. Consequently, any commissions
received by these broker-dealers and any profit on the resale of the shares
sold by them while acting as principals might be deemed to be underwriting
discounts or commissions under the Securities Act. We have agreed to indemnify
the selling stockholders against certain liabilities, including liabilities
arising under the Securities Act, or to contribute to payments which the
selling stockholders may be required to make in respect thereof.
Because the selling stockholders may be deemed to be underwriters within
the meaning of Section 2(11) of the Securities Act, the selling stockholders
will be subject to the prospectus delivery requirements of the Securities
Act, which may include delivery through the facilities of the Nasdaq National
Market pursuant to Rule 153 under the Securities Act. We have informed
the selling stockholders that the anti-manipulation provisions of Regulation
M under the Securities Exchange Act of 1934 may apply to their sales in
the market.
The selling stockholders also may resell all or a portion of the shares
in open market transactions in reliance upon Rule 144 under the Securities
Act, provided that they meet the criteria and conform to the requirements
of that rule.
Upon being notified by any selling stockholder that he has entered into any material arrangement with a broker-dealer for the sale of the shares through a block trade, special offering, exchange distribution or secondary distribution or a purchase by a broker or dealer, we will file a supplement or an amendment to this prospectus, if required, under the Securities Act, disclosing material terms of such arrangement, including but not limited to:
| the name of the selling stockholder and the participating broker-dealers; |
59
| the number of shares involved; |
| the price at which the shares were sold; |
| the commissions paid or discounts or concessions allowed to these broker-dealers, where applicable; |
| that the broker-dealers did not conduct any investigations to verify the information set out or incorporated by reference in this prospectus; and |
| other facts material to the transaction. |
We have agreed with the selling stockholders to keep the registration statement,
of which this prospectus is a part, effective for a period ending on the
earlier of (i) the date on which all shares offered under this prospectus
have been sold, or (ii) the date on which the shares offered hereby can
be sold without volume limitations under Rule 144 under the Securities
Act.
Genta common stock is listed on the Nasdaq National Market under the symbol
GNTA.
LEGAL MATTERS
Certain legal matters relating to the shares of common stock offered hereby
have been passed upon for Genta by Davis Polk & Wardwell, New York,
New York.
EXPERTS
The financial statements of Genta Incorporated as of December 31, 2002
and 2001, and for each of the three years in the period ended December
31, 2002, and the financial statements of Salus Therapeutics, Inc. as of
December 31, 2002 and for the year then ended, included in this prospectus
have been audited by Deloitte & Touche LLP, independent auditors, as
stated in their reports appearing herein and elsewhere in the registration
statement, and have been so included in reliance upon the reports of such
firm given upon their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are required by federal securities laws to file certain information
with the SEC. You can access this material on the SECs Internet website
at http://www.sec.gov. You can also read and copy this material at the
SECs public reference room, located at 450 Fifth Street, N.W., Washington,
DC 20549. Please call the SEC at (800) 732-0330 for information on how
the public reference room operates. The reference to the Uniform Resource
Locator of the SECs website is intended to be an inactive textual reference
only.
We will also send you copies of the material we file with the SEC, free
of charge, upon your request. Please call or write our Investor Relations
department at:
Genta Incorporated
Attention:
Investor Relations
Two Connell
Drive
Berkeley Heights,
NJ 07922
(908) 286-9800
This prospectus is part of a registration statement on Form S-1 we filed
with the SEC. This prospectus omits some information contained in the registration
statement in accordance with SEC rules and regulations. You should review
the information and exhibits in the registration statement for further
information on us and our common stock. Statements in this prospectus concerning
any document we
60
filed as an
exhibit to the registration statement or that we otherwise filed with the
SEC are not intended to be comprehensive and are qualified by reference
to these filings. You should review the complete document to evaluate these
statements. The registration statement, including the exhibits and schedules
thereto, are also available for reading and copying at the offices of Nasdaq
Operations, 1735 K Street, N.W., Washington, D.C. 20006.
We make available free of charge on our internet website (http://www.genta.com)
our annual report on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K and amendments to these reports filed or furnished
pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934
as soon as reasonably practicable after we electronically file such material
with, or furnish it to, the Securities and Exchange Commission. Our website
and the information contained therein or connected thereto shall not be
deemed to be incorporated into this prospectus or the registration statement
of which it forms a part.
61
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
GENTA INCORPORATED | Page |
Unaudited Condensed Consolidated Financial Statements | |
Condensed Consolidated Balance Sheets at June 30, 2003 and December 31, 2002 | F-2 |
Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2003 and 2002 | F-3 |
Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2003 and 2002 | F-4 |
Notes to Condensed Consolidated Financial Statements | F-5 |
Audited Consolidated Financial Statements | |
Independent Auditors Report | F-12 |
Consolidated Balance Sheets at December 31, 2002 and 2001 | F-13 |
Consolidated Statements of Operations for the years ended December 31, 2002, 2001 and 2000 | F-14 |
Consolidated Statements of Stockholders Equity for the years ended December 31, 2002, 2001 and 2000 | F-15 |
Consolidated Statements of Cash Flows for the years ended December 31, 2002, 2001 and 2000 | F-17 |
Notes to Consolidated Financial Statements | F-18 |
Unaudited Condensed Consolidated Pro Forma Financial Information | F-40 |
Pro Forma Condensed Consolidated Balance Sheet at June 30, 2003 | F-41 |
Pro Forma Condensed Consolidated Statement of Operations for the Six Months Ended June 30, 2003 | F-43 |
Pro Forma Condensed Consolidated Statement of Operations for the Year Ended December 31, 2002 | F-44 |
Notes to Unaudited Condensed Consolidated Pro Forma Financial Statements | F-45 |
SALUS THERAPEUTICS, INC. | |
Unaudited Condensed Financial Statements | |
Condensed Balance Sheet at June 30, 2003 | F-46 |
Condensed Statements of Operations for the Six Months ended June 30, 2003 and 2002 | F-47 |
Statement of Cash Flows for the Six Months ended June 30, 2003 | F-48 |
Notes to Condensed Financial Statements | F-49 |
Audited Financial Statements | |
Independent Auditors Report | F-52 |
Balance Sheet at December 31, 2002 | F-53 |
Statement of Operations for the Year ended December 31, 2002 | F-54 |
Statement of Cash Flows for the Year ended December 31, 2002 | F-55 |
Statement of Stockholders Equity for the Year ended December 31, 2002 | F-56 |
Notes to Financial Statements | F-57 |
F-1
Genta Incorporated
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In thousands, except par value data) | June
30,
2003 |
December
31,
2002 |
||||||
|
|
|||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 38,915 | $ | 32,700 | ||||
Short-term investments (Note 2) | 58,274 | 81,016 | ||||||
Accounts receivable (Note 3) | 19,585 | 14,574 | ||||||
Notes receivable | 275 | 200 | ||||||
Other current assets | 2,123 | 1,458 | ||||||
|
|
|||||||
Total current assets | 119,172 | 129,948 | ||||||
Property and equipment, net | 3,565 | 3,256 | ||||||
Notes receivable | 1,465 | - | ||||||
Intangibles, net | 1,151 | 1,440 | ||||||
Other assets | 1,716 | 1,775 | ||||||
|
|
|||||||
Total assets | $ | 127,069 | $ | 136,419 | ||||
|
|
|||||||
LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 5,093 | $ | 27,683 | ||||
Note payable | - | 490 | ||||||
Accrued expenses | 7,372 | 4,740 | ||||||
Deferred revenues, current portion | 5,237 | 5,237 | ||||||
Other current liabilities | 212 | 212 | ||||||
|
|
|||||||
Total current liabilities | 17,914 | 38,362 | ||||||
Deferred revenues (Note 5) | 38,736 | 41,354 | ||||||
Convertible debt (Note 6) | 10,000 | 10,000 | ||||||
Line of credit (Note 7) | 25,000 | - | ||||||
|
|
|||||||
Total liabilities | 91,650 | 89,716 | ||||||
|
|
|||||||
Commitments and contingencies | ||||||||
Stockholders equity: | ||||||||
Preferred stock, Series A convertible preferred stock, $.001 par value; 600 shares authorized, | ||||||||
261 shares issued and outstanding at June 30, 2003 and December 31, 2002, respectively; | ||||||||
liquidation value of $13,025 | - | - | ||||||
Common stock, $.001 par value; 120,000 shares authorized, 74,853 and 74,168 shares issued and | ||||||||
74,409 and 73,775 outstanding at June 30, 2003 and December 31, 2002, respectively | 75 | 74 | ||||||
Additional paid-in capital | 324,792 | 322,997 | ||||||
Accumulated deficit | (286,211 | ) | (273,190 | ) | ||||
Deferred compensation | (409 | ) | (697 | ) | ||||
Accumulated other comprehensive (loss) income | (19 | ) | 25 | |||||
|
|
|||||||
Total stockholders equity | 38,228 | 49,209 | ||||||
Cost of treasury stock: 444 and 393 shares at June 30, 2003 and December 31, 2002, respectively | (2,809 | ) | (2,506 | ) | ||||
|
|
|||||||
Total stockholders equity | 35,419 | 46,703 | ||||||
|
|
|||||||
Total liabilities and stockholders equity | $ | 127,069 | $ | 136,419 | ||||
|
|
See accompanying notes to consolidated financial statements.
F-2
Genta Incorporated
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||
(In thousands, except per share data) | 2003 | 2002 | 2003 | 2002 | ||||||||||
|
|
|
|
|||||||||||
Revenues: | ||||||||||||||
License fees and royalties (Note 5) | $ | 276 | $ | 214 | $ | 542 | $ | 219 | ||||||
Development funding (Note 5) | 1,044 | 696 | 2,087 | 696 | ||||||||||
|
|
|
|
|||||||||||
1,320 | 910 | 2,629 | 915 | |||||||||||
Costs and expenses: | ||||||||||||||
Research and development (Note 4) | (1,322 | ) | 9,693 | 4,978 | 19,530 | |||||||||
General and administrative (Note 4) | 6,131 | 8,247 | 10,911 | 11,049 | ||||||||||
Compensation expense related to stock options | 144 | 238 | 288 | 477 | ||||||||||
|
|
|
|
|||||||||||
4,953 | 18,178 | 16,177 | 31,056 | |||||||||||
|
|
|
|
|||||||||||
Loss from operations | (3,633 | ) | (17,268 | ) | (13,548 | ) | (30,141 | ) | ||||||
Other income (expense): | ||||||||||||||
Other income, principally net interest income | 435 | 299 | 887 | 545 | ||||||||||
Interest expense | (220 | ) | (100 | ) | (360 | ) | (100 | ) | ||||||
|
|
|
|
|||||||||||
215 | 199 | 527 | 445 | |||||||||||
|
|
|
|
|||||||||||
Net loss applicable to common shares | $ | (3,418 | ) | $ | (17,069 | ) | $ | (13,021 | ) | $ | (29,696 | ) | ||
|
|
|
|
|||||||||||
Net loss per common share | $ | (0.05 | ) | $ | (0.25 | ) | $ | (0.18 | ) | $ | (0.44 | ) | ||
|
|
|
|
|||||||||||
Shares used in computing net loss per common share | 74,442 | 69,184 | 74,338 | 67,862 | ||||||||||
|
|
|
|
See accompanying notes to consolidated financial statements.
F-3
Genta Incorporated
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
Six Months Ended June 30, | ||||||||
(In thousands) | 2003 | 2002 | ||||||
|
|
|||||||
Operating activities | ||||||||
Net loss | $ | (13,021 | ) | $ | (29,696 | ) | ||
Items reflected in net loss not requiring cash: | ||||||||
Depreciation and amortization | 1,040 | 768 | ||||||
Loss on disposition of patents and equipment | - | 10 | ||||||
Compensation expense related to stock options | 288 | 477 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts and notes receivable (Note 3) | (6,551 | ) | (7,126 | ) | ||||
Prepaids and other assets | (606 | ) | (5,579 | ) | ||||
Accounts payable, accrued expenses and other current liabilities | (23,066 | ) | 48,985 | |||||
|
|
|||||||
Net cash (used in) provided by operating activities | (41,916 | ) | 7,839 | |||||
|
|
|||||||
Investing activities | ||||||||
Purchase of available-for-sale short-term investments | (38,000 | ) | - | |||||
Maturities and sales of available-for-sale short-term investments | 60,698 | 15,566 | ||||||
Purchase of property and equipment | (1,060 | ) | (1,179 | ) | ||||
|
|
|||||||
Net cash provided by investing activities | 21,638 | 14,387 | ||||||
|
|
|||||||
Financing activities | ||||||||
Issuance of common stock from private placement, net | - | 71,035 | ||||||
Issuance of convertible debt | - | 10,000 | ||||||
Proceeds from line of credit (Note 7) | 25,000 | - | ||||||
Purchase of treasury stock (Note 8) | (303 | ) | (74 | ) | ||||
Proceeds from exercise of warrants and options | 1,796 | 1,758 | ||||||
|
|
|||||||
Net cash provided by financing activities | 26,493 | 82,719 | ||||||
|
|
|||||||
Increase in cash and cash equivalents | 6,215 | 104,945 | ||||||
Cash and cash equivalents at beginning of period | 32,700 | 38,098 | ||||||
|
|
|||||||
Cash and cash equivalents at end of period | $ | 38,915 | $ | 143,043 | ||||
|
|
See accompanying notes to consolidated financial statements.
F-4
Genta Incorporated
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30,
2003
(Unaudited)
(1) | Basis of Presentation |
The unaudited condensed consolidated financial statements of Genta Incorporated,
a Delaware corporation (Genta or the Company), presented herein have
been prepared in accordance with accounting principles generally accepted
in the United States of America for interim financial information and with
the instructions to Form 10-Q. Accordingly, they do not include all of
the information and note disclosures required to be presented for complete
financial statements. The accompanying financial statements reflect all
adjustments (consisting only of normal recurring accruals), which are,
in the opinion of management, necessary for a fair presentation of the
results for the interim periods presented.
The unaudited condensed consolidated financial statements and related disclosures
have been prepared with the presumption that users of the interim financial
information have read or have access to the audited financial statements
for the preceding fiscal year. Accordingly, these financial statements
should be read in conjunction with the audited consolidated financial statements
and the related notes thereto included in the Companys Annual Report on
Form 10-K for the fiscal year ended December 31, 2002. Results for the
interim periods are not necessarily indicative of results for the full
years.
The Company has experienced significant quarterly fluctuations in operating results and it expects that these fluctuations will continue.
Revenue Recognition |
In April 2002, the Company entered into a development and commercialization
agreement (the Collaborative Agreement) with Aventis Pharmaceuticals
Inc. (Aventis). Under the terms of the Collaborative Agreement, the Company
and Aventis will jointly develop and commercialize Genasense in the U.S.
(the Alliance), and Aventis will have exclusive development and marketing
rights to Genasense in all countries outside of the U.S. Under the Collaborative
Agreement, Aventis will pay 75% of U.S. New Drug Application (NDA)-directed
development costs incurred by either Genta or Aventis, subsequent to the
execution of the Collaborative Agreement, and 100% of all other development,
marketing, and sales costs incurred within the U.S. and elsewhere. Reimbursements
are to be made pursuant to a single net payment from one party to the other.
Such payments are due and payable 60 days following the end of the quarter
in which such expenses are incurred.
Initial and future funding of ongoing development received from Aventis after the achievement of certain research and development milestones (Notes 4 and 5) are being recognized over the estimated useful life of the first-to-expire related patent of 115 months.
Research and Development |
Research and development costs are expensed as incurred, including raw material costs required to manufacture products for clinical trials. Reimbursements for applicable Genasense-related costs, under the Collaborative Agreement (Note 4), have been recorded as a reduction to expenses in the condensed consolidated statements of operations.
Intangible Assets |
Intangible assets, consisting primarily of licensed technology and capitalized
patent costs, are amortized using the straight-line method over their estimated
useful lives of five years. The Companys policy is to evaluate the appropriateness
of the carrying values of the unamortized balances of intangible assets
on the basis of estimated future cash flows (undiscounted) and other factors.
If such evaluation were
F-5
to indicate
an impairment of these assets, such impairment would be recognized by a
write-down of the applicable assets. The Company evaluates the continuing
value of patents and patent applications in each financial reporting period.
Through this evaluation, the Company may elect to continue to maintain
these patents, seek to out-license them, or abandon them.
Future amortization expense related to intangibles at June 30, 2003 follows
($ thousands):
Amortization
Expense |
|||||
2003 | $ | 288 | |||
2004 | 577 | ||||
2005 | 286 | ||||
2006 | - | ||||
2007 | - | ||||
Thereafter | - | ||||
|
|||||
Total | $ | 1,151 | |||
|
Stock Options
The Company accounts for stock-based compensation arrangements in accordance
with provisions of Accounting Principles Board (APB) Opinion No. 25,
Accounting
for Stock Issued to Employees and complies with the disclosure provisions
of Statement of Financial Accounting Standards (SFAS) No. 123, Accounting
for Stock-Based Compensation. Under APB Opinion No. 25, compensation expense
is based on the difference, if any, on the date of grant, between the fair
value of the Companys stock and the exercise price. The Company accounts
for stock options issued to non-employees in accordance with the provisions
of SFAS No. 123, and Emerging Issues Task Force Consensus on Issue No.
96-18, Accounting for Equity Instruments That Are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or Services.
The Company is amortizing deferred stock compensation using the graded
vesting method, in accordance with Financial Accounting Standards Board
Interpretation No. 28, over the vesting period of each respective option,
which is generally four years.
In December 2002, the Financial Accounting Standards Board (FASB) issued
SFAS No. 148, Accounting for Stock-Based Compensation Transition and
Disclosure Amendment of FASB Statement No. 123, to provide alternative
methods of transition for a voluntary change to the fair value based method
of accounting for stock-based employee compensation. In addition, this
Statement amends the disclosure requirements of Statement No. 123 to require
prominent disclosures in both annual and interim financial statements about
the method of accounting for stock-based employee compensation and the
effect of the method used on reported results.
The following table illustrates the effect on net loss and loss per share
if the Company had applied the fair value recognition provisions of SFAS
No. 123 to stock-based employee compensation:
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||
($ thousands, except per share data) | 2003 | 2002 | 2003 | 2002 | |||||
|
|
|
|
||||||
Net loss applicable to common shares, as reported | $(3,418 | ) | $(17,069 | ) | $(13,021 | ) | $(29,696 | ) | |
Equity related employee compensation expense included in reported net income, | |||||||||
net of related tax effects | 144 | 238 | 288 | 477 | |||||
Total stock-based employee compensation expense determined under fair values | |||||||||
based method for all awards, net of related tax effects | (1,907 | ) | (1,909 | ) | (3,455 | ) | (3,576 | ) | |
|
|
|
|
||||||
Pro forma net loss applicable to common shares | $(5,181 | ) | $(18,740 | ) | $(16,188 | ) | $(32,795 | ) | |
|
|
|
|
||||||
Net loss per common share: | |||||||||
As reported: Basic and diluted | $(0.05 | ) | $(0.25 | ) | $(0.18 | ) | $(0.44 | ) | |
Pro forma: Basic and diluted | $(0.07 | ) | $(0.27 | ) | $(0.22 | ) | $(0.48 | ) |
F-6
Pro Forma Disclosure |
The fair value of options for the three months ended June 30, 2003 and
2002, has been estimated at the date of grant using the minimum value option
pricing model with the following assumptions:
Three Months Ended June 30, | |||||
2003
|
2002
|
||||
Risk-free interest rate | 2.5 | % | 2.8 | % | |
Dividend yield | - | - | |||
Expected life (years) | 4.0 | 5.0 | |||
Volatility | 65.0 | % | 65.0 | % |
All of the options issued during the three-month periods ended June 30, 2003 and 2002, were issued with an exercise price equal to market value on the date of grant. The weighted-average estimated fair value of stock options granted was $9.86 per share and $10.32 per share for the three-month periods ended June 30, 2003 and 2002, respectively.
Net Loss Per Common Share |
Basic and diluted loss per common share are identical for the three months ended June 30, 2003 and 2002 as potentially dilutive securities, including options, warrants and convertible preferred stock have been excluded in the calculation of the net loss per common share due to their anti-dilutive effect.
Recent Accounting Pronouncements |
In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial
Instruments with Characteristics of Liabilities, Equity, or Both. This
limited scope statement prescribes changes to the classification of preferred
securities of subsidiary trusts and the accounting for forward purchase
contracts issued by a company in its own stock. SFAS No. 150 does not apply
to features that are embedded in a financial instrument that is not a derivative
in its entirety and requires all preferred securities of subsidiary trusts
to be classified as debt on the consolidated balance sheet and the related
dividends as interest expense. As the Company did not have any financial
instruments within the scope of SFAS No. 150, its adoption did not have
any impact on the Companys results of operations, financial position or
cash flows.
In April 2003, the FASB issued SFAS No. 149, Amendment of Statement
133 on Derivative Instruments and Hedging Activities. SFAS No. 149
amends and clarifies financial accounting and reporting for derivative
instruments, including certain derivative instruments embedded in other
contracts (collectively referred to as derivatives) and for hedging activities
under SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities. In particular, SFAS No. 149 (1) clarifies under what circumstances
a contract with an initial net investment meets the characteristic of a
derivative discussed in paragraph 6(b) of SFAS No. 133, (2) clarifies when
a derivative contains a financing component, (3) amends the definition
of an underlying to conform it to language used in FIN 45, Guarantors
Accounting and Disclosure Requirements for Guarantees, Including Indirect
Guarantees of Indebtedness of Others, and (4) amends certain other
existing pronouncements. SFAS No. 149 is to be applied prospectively to
contracts entered into or modified after June 30, 2003, with certain exceptions,
and for hedging relationships designated after June 30, 2003. Management
believes that adopting this statement will not have a material impact on
the Companys results of operations, financial position or cash flows.
In August 2001, the FASB issued SFAS No. 143, Accounting for Asset Retirement
Obligations. SFAS No. 143 addresses financial accounting and reporting
for obligations associated with the retirement of tangible long-lived assets
and the associated asset retirement costs. SFAS No. 143 requires that the
fair value of a liability for an asset retirement obligation be recognized
in the period in which it is incurred if a reasonable estimate of fair
value can be made. The associated asset retirement costs are capitalized
as part of the carrying amount of the long-lived asset. The Company adopted
SFAS No. 143 effective January
F-7
1, 2003. The adoption did not have any material impact on the Companys results of operations, financial position or cash flows.
(2) | Short-Term Investments |
The carrying amounts of short-term investments approximate fair value due
to the short-term nature of these instruments. The fair value of available-for-sale
marketable securities at June 30, 2003 is as follows ($ thousands):
Amortized costs | $ | 58,293 | |
Gross unrealized gains | 32 | ||
Gross unrealized losses | (51 | ) | |
|
|||
Estimated fair value | $ | 58,274 | |
|
The estimated fair value of each marketable security has been compared to its cost, and therefore, an unrealized loss of approximately $0.019 million has been recognized in accumulated other comprehensive (loss) income at June 30, 2003.
(3) | Accounts Receivable |
Included in accounts receivable and netted against operating expenses in
the condensed consolidated statement of operations for the three months
ended June 30, 2003, is $19.433 million in net expense reimbursements due
from Aventis for various third-party costs, internal costs of scientific
and technical personnel (Full-time Equivalents or FTEs) and Genasense
drug supply costs. Information with respect to the cost reimbursement for
the three months ended June 30, 2003 is presented below ($ thousands):
Reimbursement to Genta: | |||
Third-party costs | $ | 8,822 | |
Drug supply costs | 9,192 | ||
FTEs | 1,793 | ||
|
|||
Amount due to Genta | 19,807 | ||
Reimbursement to Aventis: | |||
FTEs | (374 | ) | |
|
|||
Net amount due to Genta | $ | 19,433 | |
|
(4) | Collaborative Agreement |
In April 2002, the Company entered into a Collaborative Agreement with
Aventis. Under the terms of the Collaborative Agreement, the Alliance will
jointly develop and commercialize Genasense in the U.S., and Aventis will
have exclusive development and marketing rights to Genasense in all countries
outside of the U.S. Under the Collaborative Agreement, Aventis will pay
75% of U.S. NDA-directed development costs incurred by either Genta or
Aventis, subsequent to the execution of the Collaborative Agreement, and
100% of all other development, marketing, and sales costs incurred within
the U.S. and elsewhere. An analysis of expenses reimbursable under the
Collaborative Agreement (Note 1) follows:
($ thousands) | Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
|
|
|||||||||||
2003 | 2002 | 2003 | 2002 | |||||||||
|
|
|
|
|||||||||
Research and development expenses, gross | $ | 18,111 | $ | 16,442 | $ | 33,568 | $ | 26,279 | ||||
Less net expense reimbursement | (19,433 | ) | (6,749 | ) | (28,590 | ) | (6,749 | ) | ||||
|
||||||||||||
Research and development expenses, net | $ | (1,322 | ) | $ | 9,693 | $ | 4,978 | $ | 19,530 | |||
|
|
|
|
|||||||||
General and administrative, gross | $ | 6,131 | $ | 8,670 | $ | 10,911 | $ | 11,472 | ||||
Less expense reimbursement | - | (423 | ) | - | (423 | ) | ||||||
|
|
|
|
|||||||||
General and administrative, net | $ | 6,131 | $ | 8,247 | $ | 10,911 | $ | 11,049 | ||||
|
|
|
|
F-8
As of June 30, 2003, the Company has received a total of $194.4 million in initial and near-term funding, which included a $10.0 million licensing fee and $40.0 million in development funding (Note 5), $10.0 million in convertible debt proceeds (Note 6), $71.9 million pursuant to an at-market equity investment in the Companys common stock, $37.5 million in paid expense reimbursements and $25.0 million in line of credit proceeds (Note 7). A further $19.6 million in accrued expense reimbursement is due for payment during the third quarter of 2003 (Note 3), which includes $0.1 million due from December 31, 2002. The remaining amounts that could be received under the Collaborative Agreement, $280.0 million in cash and $65.0 million in convertible note proceeds, are contingent upon the achievement of certain research and development milestones.
(5) | Deferred Revenues |
As of June 30, 2003, the Company had recorded $44.0 million in deferred revenues relating to the initial $10.0 million licensing fee and $40.0 million development funding received under the Collaborative Agreement (Note 4), of which $5.2 million is included in current liabilities and $38.8 million is classified as long-term deferred revenues, which are being recognized over the estimated useful life of the first-to-expire related patent of 115 months. Any subsequent milestone payments that may be received from Aventis will also be recognized over the then, remaining estimated useful life of the first-to-expire related patent. Separately, as of June 30, 2003, the Company had recorded $0.01 million in royalties.
(6) | Convertible Debt |
At June 30, 2003, the Company had $10.0 million in convertible debt that was issued in connection with the Collaborative Agreement (Note 4). The Company received $10.0 million in debt proceeds from Aventis, and issued a $10.0 million convertible promissory note to Aventis (Aventis Note). Interest accrues at the rate of 5.63% per annum until April 26, 2009 (the Maturity Date) and compounds annually on each anniversary date of the Aventis Note through the Maturity Date. The Company may redeem the Aventis Note for cash in whole or in part (together with any accrued and unpaid interest with respect to such principal amount) in amounts of not less than $0.5 million (and in $0.1 million increments thereafter). In addition, the Company may convert the Aventis Note on or prior to the Maturity Date in whole or in part (together with any accrued and unpaid interest with respect to such principal amount) in amounts of not less than $5.0 million (and in $1.0 million increments thereafter), into fully paid and non-assessable shares of common stock (calculated as to the nearest 1/1000 of a share). As of any date, the number of shares of common stock into which the Aventis Note may be converted shall be determined by a formula based on the then market value of the common stock (the Conversion Price), subject to a minimum Conversion Price of $8.00 per share.
(7) | Aventis Line of Credit |
At June 30, 2003, the Company had $25.0 million outstanding on a line of
credit that was issued in connection with an amendment, dated March 14,
2003, to the Collaborative Agreement (Note 4) that established a $40.0
million line of credit related to the development, manufacturing and commercialization
of Genasense (Aventis Credit Line). The amendment provides Genta the
immediate availability of up to $40.0 million in cash. This revolving debt
will be considered an advance against both past and future costs and will
be secured by reimbursable development expenses from Aventis, as well as
drug inventory. At the time of Genasense NDA approval in the U.S., any
outstanding balance will be offset against the first milestone payment
that is due to Genta from Aventis. The terms of the Aventis Credit Line
provide for a favorable interest rate, which is set two days prior to the
first day of each calendar quarter. The Aventis Credit Line terminates
upon the earlier of (1) the receipt of Genasense NDA approval in the U.S.,
(2) notice given by either Genta or Aventis of the termination of the Collaborative
Agreement, (3) notice given by Genta of the termination of the Aventis
Credit Line, (4) various default provisions or (5) December 31, 2004. Depending
upon the circumstances, repayment is due immediately or up to six months
after the termination of the Aventis Credit Line.
F-9
(8) | Treasury Stock |
In June 2002 the Company commenced a stock repurchase program, whereby
up to 5.0 million shares of its common stock may be repurchased by the
Company at prices deemed desirable by the Company. As of June 30, 2003,
the Company had repurchased 444,200 shares of common stock in open-market
transactions as follows:
Shares | Average price per | ||||
Repurchased | share | ||||
|
|
||||
At December 31, 2002 | 392,700 | $ | 6.3807 | ||
Six Months Ended June 30, 2003 | 51,500 | 5.8927 | |||
|
|
||||
444,200 | $ | 6.3242 | |||
|
|
(9) | Comprehensive Loss |
An analysis of comprehensive loss is presented below:
($ thousands) | Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
|
|
|||||||||||
2003 | 2002 | 2003 | 2002 | |||||||||
|
|
|
|
|||||||||
Net loss | $ | (3,418 | ) | $ | (17,069 | ) | $ | (13,021 | ) | $ | (29,696 | ) |
Change in market value on available-for-sale short- | ||||||||||||
term investments | (28 | ) | 116 | (44 | ) | 60 | ||||||
|
|
|
|
|||||||||
Total comprehensive loss | $ | (3,446 | ) | $ | (16,953 | ) | $ | (13,065 | ) | $ | (29,636 | ) |
|
|
|
|
(10) | Supplemental Disclosure of Cash Flows Information and Non-cash Investing and Financing Activities |
No interest was paid for the six months ended June 30, 2003 and 2002.
(11) | Commitments and Contingencies |
Litigation and Potential Claims |
JBL |
The sale of JBL Scientific, Inc. (JBL), the Companys manufacturing subsidiary, was completed on May 10, 1999. JBL was notified on October 1998 from Region IX of the Environmental Protection Agency (EPA) that it had been identified as a potentially responsible party (PRP) at the Casmalia Disposal Site, which is located in Santa Barbara, California. JBL has been designated as a de minimis PRP by the EPA. In December 2001, Genta received a revised settlement proposal from the EPA in the amount of $0.033 million, the terms of the settlement with the EPA containing standard contribution protection and release language. In January 2002, the Company accepted the proposal and paid the $0.033 million as an offer to settle this matter. There can be no assurance, however, that the EPA will not reject our settlement offer if there is not a sufficient number of PRPs settling with the EPA.
Genta Europe |
During 1995, Genta Pharmaceuticals Europe S.A. (Genta Europe), a wholly-owned
subsidiary of Genta, received funding in the form of a loan from ANVAR,
a French government agency, of which the proceeds were intended to fund
research and development activities. In October 1996, in connection with
a restructuring of Gentas operations, Genta terminated all scientific
personnel of Genta Europe. In 1998, ANVAR asserted that Genta Europe was
not in compliance with the ANVAR Agreement, notified Genta Europe of its
demand for accelerated repayment of the loan and notified Genta that it
was liable as a guarantor on the note. Based on the advice of French counsel,
Genta does not believe that ANVAR is entitled to payment under the terms
of the ANVAR Agreement and also believes it to be unlikely that Genta
F-10
will incur any liability in this matter, although there can be no assurance thereof. At June 30, 2003, the Company has accrued a net liability of $0.212 million related to this matter, which management believes is adequate to provide for this contingency.
University of Pennsylvania |
In October 2002, a licensing officer from the University of Pennsylvania (UPenn) asserted a claim to a portion of the initial $40.0 million development funding (Note 5) the Company received from Aventis pursuant to the Collaborative Agreement. The Company has disputed this claim and has filed a petition for binding arbitration for this matter, as provided in the original licensing agreement between the Company and UPenn. The Company and UPenn are currently discussing the possibility of entering into a settlement with respect to this matter. Under the terms of the proposed settlement, in exchange for an agreement by UPenn to forego any and all claims in the future to any portion of any milestone and other payments (other than royalty payments) made to Genta pursuant to the Collaborative Agreement, Genta would make the following payments to UPenn: (i) $750,000 on October 1, 2003, (ii) $250,000 on February 2, 2004, (iii) $1.5 million upon the first NDA or foreign equivalent approval of Genasense (the first Genasense approval), and (iv) provided that the first Genasense approval has been received by Genta, $750,000 on the earlier of (a) the second NDA or foreign equivalent approval of Genasense or (b) December 30, 2004. The proposed settlement, including the aforementioned monetary terms, is still subject to the parties reaching agreement on certain other matters, and no assurance can be given that the parties will reach any such agreement and that the proposed settlement will be entered into on these monetary terms, if at all.
At the current time the Company cannot reasonably estimate the outcome of this claim; however, the Company does not believe that this claim will have a material adverse impact on the Companys financial results and liquidity. As of June 30, 2003, the Company has not reserved any amount for royalty payments that could be due to UPenn as a result of binding arbitration.
Purchase Commitments |
Per an agreement entered into with Avecia Biotechnology, Inc. (Avecia)
in December 2002 (the Supply Agreement) the Company is obligated for
up to $27.5 million in drug substance purchases during 2003. Pursuant to
the Collaborative Agreement with Aventis (Note 4), the Company anticipates
that it will be reimbursed for at least 75% of these purchase commitments
after the drug is shipped to the clinical sites. No drug substance purchases
were made in the first half of 2003, primarily due to the significant amount
of drug substance purchased in the fourth quarter of 2002. In addition,
the Company has committed up to $5.0 million of advance financing to Avecia
for facility expansion, which would be recovered with interest through
future payments determined as a function of drug substance purchases to
be made by the Company in the future. As of July 15, 2003, the Company
had paid $1.448 million in advance financing.
F-11
INDEPENDENT AUDITORS REPORT
To the Board
of Directors and Stockholders of
Genta Incorporated
We have audited the accompanying consolidated balance sheets of Genta Incorporated
and subsidiaries (the Company) as of December 31, 2002 and 2001, and
the related consolidated statements of operations, stockholders equity,
and cash flows for each of the three years in the period ended December
31, 2002. These financial statements are the responsibility of the Companys
management. Our responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with auditing standards generally
accepted in the United States of America. Those standards require that
we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An audit includes
examining, on a test basis, evidence supporting the amounts and disclosures
in the financial statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, such consolidated financial statements present fairly,
in all material respects, the financial position of Genta Incorporated
as of December 31, 2002 and 2001, and the results of their operations and
their cash flows for each of the three years in the period ended December
31, 2002, in conformity with accounting principles generally accepted in
the United States of America.
/s/ DELOITTE
& TOUCHE LLP
Parsippany,
New Jersey
February 13,
2003
(except Note
21, as to which the date is March 17, 2003)
F-12
GENTA INCORPORATED
CONSOLIDATED
BALANCE SHEETS
(In thousands, except par value data)
December 31, | December 31, | |||||
ASSETS | 2002 | 2001 | ||||
|
|
|||||
Current assets: | ||||||
Cash and cash equivalents (Note 2) | $ | 32,700 | $ | 38,098 | ||
Short term investments (Note 3) | 81,016 | 15,988 | ||||
Accounts receivable (Note 4) | 14,574 | 36 | ||||
Notes receivable (Note 5) | 200 | 200 | ||||
Prepaid expenses and other current assets (Note 6) | 1,458 | 707 | ||||
|
|
|||||
Total current assets | 129,948 | 55,029 | ||||
Property and equipment, net (Note 7) | 3,256 | 1,848 | ||||
Intangibles, net (Note 9) | 1,440 | 2,120 | ||||
Prepaid royalties (Note 10) | 1,268 | 1,268 | ||||
Deposits and other assets (Note 16) | 507 | 365 | ||||
|
|
|||||
Total assets | $ | 136,419 | $ | 60,630 | ||
LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 27,683 | $ | 9,571 | ||
Notes payable (Note 6) | 490 | | ||||
Accrued expenses (Note 11) | 4,740 | 2,309 | ||||
Deferred revenues, current portion (Note 13) | 5,237 | 90 | ||||
Other current liabilities | 212 | 350 | ||||
|
|
|||||
Total current liabilities | 38,362 | 12,320 | ||||
Deferred revenues (Note 13) | 41,354 | | ||||
Convertible debt (Note 14) | 10,000 | | ||||
|
|
|||||
Total liabilities | 89,716 | 12,320 | ||||
|
|
|||||
Commitments and contingencies (Note 19) | ||||||
Stockholders equity (Note 17): | ||||||
Series A convertible preferred stock, $.001 par value; 600 shares | ||||||
authorized, 261 shares issued and outstanding at December 31, 2002 | ||||||
and December 31, 2001, respectively; liquidation value of $13,025 and $13,050, | ||||||
respectively | | | ||||
Common stock, $.001 par value; 120,000 shares authorized, 74,168 and 66,000 | ||||||
shares issued and outstanding at December 31, 2002 and December 31, 2001, | ||||||
respectively | 74 | 66 | ||||
Additional paid-in capital | 322,997 | 248,685 | ||||
Accumulated deficit | (273,190 | ) | (198,662 | ) | ||
Deferred compensation | (697 | ) | (1,713 | ) | ||
Accumulated other comprehensive (loss) income | 25 | (66 | ) | |||
|
|
|||||
49,209 | 48,310 | |||||
Less cost of treasury stock: 393 shares at December 31, 2002 | (2,506 | ) | | |||
|
|
|||||
Total stockholders equity | 46,703 | 48,310 | ||||
|
|
|||||
Total liabilities and stockholders equity | $ | 136,419 | $ | 60,630 | ||
|
|
See accompanying notes to consolidated financial statements.
F-13
GENTA INCORPORATED
CONSOLIDATED
STATEMENTS OF OPERATIONS
Years Ended December 31, | |||||||||
|
|||||||||
(In thousands, except per share data) | 2002 | 2001 | 2000 | ||||||
|
|
|
|||||||
Revenues: | |||||||||
License fees (Note 13) | $ | 3,498 | $ | 97 | $ | 17 | |||
Royalties | 61 | 49 | 5 | ||||||
|
|
|
|||||||
3,559 | 146 | 22 | |||||||
Costs and expenses: | |||||||||
Research and development (Note 12) | 58,899 | 39,355 | 6,830 | ||||||
General and administrative (Note 12) | 19,347 | 8,215 | 3,323 | ||||||
Equity related compensation (Note 18) | 1,016 | 1,074 | 8,605 | ||||||
Promega settlement (Note 5) | | 1,000 | | ||||||
|
|
|
|||||||
79,262 | 49,644 | 18,758 | |||||||
|
|
|
|||||||
Loss from operations | (75,703 | ) | (49,498 | ) | (18,736 | ) | |||
Equity in net income of joint venture (Note 8) | 33 | | 502 | ||||||
Other income | 1,326 | 2,785 | 5,783 | ||||||
Income taxes (Note 15) | (184 | ) | | | |||||
|
|
|
|||||||
Net loss | (74,528 | ) | (46,713 | ) | (12,451 | ) | |||
Preferred stock dividends (Note 17) | | | (3,443 | ) | |||||
|
|
|
|||||||
Net loss applicable to common shares | $ | (74,528 | ) | $ | (46,713 | ) | $ | (15,894 | ) |
|
|
|
|||||||
Net loss per common share | $ | (1.05 | ) | $ | (0.84 | ) | $ | (0.41 | ) |
|
|
|
|||||||
Shares used in computing net loss per common share | 70,656 | 55,829 | 38,659 | ||||||
|
|
|
See accompanying notes to consolidated financial statements.
F-14
GENTA INCORPORATED
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS EQUITY
For the
Years Ended December 31, 2000, 2001 and 2002
Convertible
Preferred Stock |
Common
Stock
|
Treasury
Stock
|
|||||||||||||||||||||||
(In thousands) | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital |
Accumulated Deficit |
Accrued
Dividends Payable |
Deferred Compensation |
Other Comprehensive Income (Loss) |
Total
Stockholders Equity |
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at January 1, 2000 | 400 | $ - | 25,457 | $26 | - | $ - | $146,863 | $(139,498 | ) | $5,134 | $(2,318 | ) | $ - | $10,207 | |||||||||||
Comprehensive loss: | |||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (12,451 | ) | - | - | - | (12,451 | ) | |||||||||||
Unrealized investment gain | - | - | - | - | - | - | - | - | - | - | 95 | 95 | |||||||||||||
|
|||||||||||||||||||||||||
Total comprehensive loss | (12,356 | ) | |||||||||||||||||||||||
Issuance
of common stock upon conversion
of convertible preferred stock |
(139 | ) | - | 14,486 | 15 | - | - | (14 | ) | - | - | - | - | 1 | |||||||||||
Issuance
of common stock in connection with
two private placements, net of issuance |
|||||||||||||||||||||||||
costs of $2,548 | - | - | 6,458 | 6 | - | - | 40,095 | - | - | - | - | 40,101 | |||||||||||||
Issuance
of common stock in connection with
exercise of warrants and stock options |
- | - | 3,345 | 3 | - | - | 3,254 | - | - | - | - | 3,257 | |||||||||||||
Preferred stock dividends | - | - | 953 | 1 | - | - | 5,133 | - | (5,134 | ) | - | - | - | ||||||||||||
Equity related compensation | - | - | - | - | - | - | 7,368 | - | - | 1,237 | - | 8,605 | |||||||||||||
Issuance
of common stock in connection with
rights to Relgen license agreement |
- | - | 10 | - | - | - | 84 | - | - | - | - | 84 | |||||||||||||
Issuance
of common stock in connection with
MBI asset purchase |
- | - | 376 | - | - | - | 2,400 | - | - | - | - | 2,400 | |||||||||||||
Value
of shares to be issued related to license
agreement |
- | - | - | - | - | - | 1,268 | - | - | - | - | 1,268 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at December 31, 2000 | 261 | - | 51,085 | 51 | - | - | 206,451 | (151,949 | ) | - | (1,081 | ) | 95 | 53,567 | |||||||||||
Comprehensive loss: | |||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (46,713 | ) | - | - | - | (46,713 | ) | |||||||||||
Unrealized investment loss | - | - | - | - | - | - | - | - | - | - | (161 | ) | (161 | ) | |||||||||||
|
|||||||||||||||||||||||||
Total comprehensive loss | (46,874 | ) | |||||||||||||||||||||||
Issuance
of common stock upon conversion
of convertible preferred stock |
- | - | 2 | - | - | - | - | - | - | - | - | - | |||||||||||||
Issuance
of common stock in connection with
private placement, net of issuance |
|||||||||||||||||||||||||
costs of $502 | - | - | 2,500 | 3 | - | - | 32,220 | - | - | - | - | 32,223 | |||||||||||||
Issuance
of common stock in connection with
exercise of warrants and stock options . |
- | - | 12,245 | 12 | - | - | 8,309 | - | - | - | - | 8,321 | |||||||||||||
Issuance of common stock as hiring bonus | - | - | 6 | - | - | - | - | - | - | - | - | - | |||||||||||||
Issuance
of common stock related to license
agreement |
- | - | 162 | - | - | - | - | - | - | - | - | - |
See accompanying notes to consolidated financial statements.
F-15
Convertible
Preferred Stock |
Common
Stock
|
Treasury
Stock
|
|||||||||||||||||||||||
(In thousands) | Shares | Amount | Shares | Amount | Shares | Amount |
Additional Paid-in Capital |
Accumulated Deficit |
Accrued Dividends Payable |
Deferred Compensation |
Other Comprehensive Income (Loss) |
Total Stockholders Equity |
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Equity related compensation | - | - | - | - | - | - | 1,705 | - | - | (632 | ) | - | 1,073 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at December 31, 2001 | 261 | - | 66,000 | 66 | - | - | 248,685 | (198,662 | ) | - | (1,713 | ) | (66 | ) | 48,310 | ||||||||||
Comprehensive loss: | |||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (74,528 | ) | - | - | - | (74,528 | ) | |||||||||||
Unrealized investment loss | - | - | - | - | - | - | - | - | - | - | 91 | 91 | |||||||||||||
|
|||||||||||||||||||||||||
Total comprehensive loss | (74,437 | ) | |||||||||||||||||||||||
Issuance
of common stock in connection with
private placement, net of issuance |
|||||||||||||||||||||||||
costs of $899 | - | - | 6,665 | 7 | - | - | 71,028 | - | - | - | - | 71,035 | |||||||||||||
Issuance
of common stock in connection with
exercise of warrants and stock options . |
- | - | 1,503 | 1 | - | - | 3,284 | - | - | - | - | 3,285 | |||||||||||||
Purchase of treasury stock (Note 17) | - | - | - | - | (393 | ) | (2,506 | ) | - | - | - | - | - | (2,506 | ) | ||||||||||
Equity related compensation | - | - | - | - | - | - | - | - | - | 1,016 | - | 1,016 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at December 31, 2002 | 261 | - | 74,168 | $74 | (393 | ) | $(2,506 | ) | $322,997 | $(273,190 | ) | $ - | $(697 | ) | $25 | $46,703 | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-16
GENTA INCORPORATED
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Years Ended December 31, | |||||||||
|
|||||||||
(In thousands) | 2002 | 2001 | 2000 | ||||||
|
|
|
|||||||
Operating activities: | |||||||||
Net loss | $ | (74,528 | ) | $ | (46,713 | ) | $ | (12,451 | ) |
Items reflected in net loss not requiring cash: | |||||||||
Depreciation and amortization | 1,646 | 1,131 | 581 | ||||||
Loss on disposition of equipment | 13 | 19 | 7 | ||||||
Promega settlement (Note 5) | | 1,000 | | ||||||
Non-cash equity related compensation (Note 18) | 1,016 | 1,074 | 8,605 | ||||||
Changes in operating assets and liabilities: | |||||||||
Accounts, notes and loan receivable (Note 4 & 5) | (14,538 | ) | 102 | (84 | ) | ||||
Other assets (Note 6) | (751 | ) | (282 | ) | (288 | ) | |||
Accounts payable, accrued and other expenses | 20,895 | 8,679 | 1,634 | ||||||
Deferred revenue (Note 13) | 46,501 | | | ||||||
|
|
|
|||||||
Net cash used in operating activities | (19,746 | ) | (34,990 | ) | (1,996 | ) | |||
|
|
|
|||||||
Investing activities: | |||||||||
Purchase of available-for-sale short-term investments (Note 3) | (88,317 | ) | (14,521 | ) | (33,389 | ) | |||
Maturities of available-for-sale short-term investments (Note 3) | 23,380 | 29,546 | 2,296 | ||||||
Purchase of property and equipment | (2,387 | ) | (1,438 | ) | (778 | ) | |||
Purchase of intangibles | | | (400 | ) | |||||
Deposits and other | (142 | ) | (68 | ) | (167 | ) | |||
|
|
|
|||||||
Net cash (used in) provided by investing activities | (67,466 | ) | 13,519 | (32,438 | ) | ||||
|
|
|
|||||||
Financing activities: | |||||||||
Proceeds from private placements of common stock, net | |||||||||
(Note 17) | 71,035 | 32,223 | 40,101 | ||||||
Proceeds from convertible debt (Note 14) | 10,000 | | | ||||||
Purchase of treasury stock (Note 17) | (2,506 | ) | | | |||||
Proceeds from exercise of warrants and options (Note 17 & 18) | 3,285 | 8,321 | 3,257 | ||||||
|
|
|
|||||||
Net cash provided by financing activities | 81,814 | 40,544 | 43,358 | ||||||
|
|
|
|||||||
(Decrease) increase in cash and cash equivalents | (5,398 | ) | 19,073 | 8,924 | |||||
Cash and cash equivalents at beginning of year | 38,098 | 19,025 | 10,101 | ||||||
|
|
|
|||||||
Cash and cash equivalents at end of year | $ | 32,700 | $ | 38,098 | $ | 19,025 | |||
|
|
|
See accompanying notes to consolidated financial statements.
F-17
GENTA INCORPORATED
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 2002, 2001 and 2000
1. | Organization and Business |
Genta Incorporated (Genta or the Company) is a biopharmaceutical company
engaged in pharmaceutical (drug) research and development, its sole reportable
segment. The Company is dedicated to developing innovative drugs to treat
cancer. In the past, the Companys research efforts have focused primarily
on the development of antisense drugs, which are designed to selectively
prevent the production of specific proteins that contribute to the cause
or progression of disease. More recently, the Company has broadened its
research portfolio into other DNA medicines, which, in addition to antisense
drugs, consist of decoy and small molecules, which include the Companys
gallium products and Androgenics compounds.
The Company previously manufactured and marketed specialty biochemicals
and intermediate products through its manufacturing subsidiary, JBL Scientific,
Inc. (JBL). Substantially all of the subsidiarys assets were sold in
May 1999, and accordingly, JBL is presented as a discontinued operation
for the year ended December 31, 1999 (Note 20). The Company also has a
50% equity interest in Genta Jago Technologies B.V. (Genta Jago), a drug
delivery system joint venture with SkyePharma, PLC (SkyePharma). In March
1999, Genta and SkyePharma entered into an interim agreement pursuant to
which the parties to the joint venture released each other from all liability
relating to unpaid development costs and funding obligations. Since the
first quarter of 2000, there has been immaterial activity within the joint
venture and we are currently seeking to terminate our involvement. In August
1999, the Company acquired Androgenics Technologies, Inc. (Androgenics),
which developed a proprietary series of compounds that act to inhibit the
growth of prostate cancer cells. In April 2000, the Company entered into
an asset purchase agreement with Relgen LLC, a privately held corporation
and a party related to Genta, in which the Company acquired all assets,
rights and technology to a portfolio of gallium containing compounds, including
Ganite.
The Company has had recurring operating losses since inception and management
expects that such losses will continue for the next couple years or until
Genasense receives approval from the FDA for commercial sales and we receive
a full year of royalties from Aventis on worldwide sales. Although no assurances
can be expressed, management believes that at the current rate of spending,
coupled with the amounts to be reimbursed by and the available line of
credit from Aventis, the Company should have sufficient cash funds to maintain
its present operations to the end of 2004. Additional Aventis milestone
payments and other funding available to the Company upon the anticipated
NDA approval of Genasense should provide sufficient capital resources
for beyond 2004.
The Company may also seek collaborative agreements, equity financing and other financing arrangements with potential corporate partners and other sources. However, there can be no assurance that any such collaborative agreements or other sources of funding will be available on favorable terms, if at all. The Company will need substantial additional funds before it can expect to realize significant product revenue.
2. | Summary of Significant Accounting Policies |
Basis of Presentation |
The consolidated financial statements are presented on the basis of generally
accepted accounting principles recognized in the United States. All professional
accounting standards that are effective as of December 31, 2002 have been
considered in preparing the consolidated financial statements. Such financial
statements include the accounts of the Company and all majority-owned subsidiaries.
All material intercompany transactions and balances have been eliminated
in consolidation. The preparation
F-18
of financial statements in conformity with generally accepted accounting principles requires management to make certain estimates and assumptions that affect reported earnings, financial position and various disclosures. Actual results could differ from those estimates.
Revenue Recognition |
In April 2002, the Company entered into a development and commercialization
agreement (Collaborative Agreement) with Aventis Pharmaceuticals Inc.
(Aventis). Under the terms of the Collaborative Agreement, the Company
and Aventis will jointly develop and commercialize Genasense in the U.S.
(the Alliance), and Aventis will have exclusive development and marketing
rights to the compound in all countries outside of the U.S. Under the Collaborative
Agreement, Aventis will pay 75% of U.S. NDA-directed development costs
incurred by either Genta or Aventis, subsequent to the execution of the
Collaborative Agreement, and 100% of all other development, marketing,
and sales costs incurred within the U.S. and elsewhere as subject to the
Collaborative Agreement (Note 12). Reimbursements are to be made pursuant
to a single net payment from one party to the other. Such payments are
due and payable 60 days following the end of the quarter in which such
expenses are incurred.
Consistent with Staff Accounting Bulletin No. 101 Revenue Recognition
(SAB 101), initial funding of ongoing development received from Aventis
after the achievement of certain research and development milestones (Note
12) will be recognized on a straight-line basis over the estimated useful
life of the related first-to-expire patent of 115 months. Any subsequent
milestone payments that may be received from Aventis will also be recognized
over the then, remaining estimated useful life of the related first-to-expire
patent.
In 2001 and 2000, the Company entered into worldwide non-exclusive license agreements. The license agreements each have initial terms that expire in 2010 and include upfront payments in cash, annual licensing fee payments for two years, and future royalties on product sales. The Companys policy is to recognize revenues under these arrangements when delivery has occurred or services have been rendered, persuasive evidence of an arrangement exists, the fee is fixed and determinable and collectibility is reasonably assured. Since each of the aforementioned licensing arrangements have variable payment terms extending beyond one year, such fees are recognized as earned.
Research and Development |
Research and development costs are expensed as incurred, including raw
material costs required to manufacture products for clinical trials. Once
Genta has submitted an NDA, which includes the results of the preclinical
and clinical testing, chemistry, manufacturing and control information,
to the FDA for approval to commence commercial sales, Genta will then include
the sales launch product, consisting of raw materials and all subsequent
processing costs required to produce finished goods, as inventory on Gentas
balance sheet in anticipation of approval by the FDA.
Reimbursements for applicable Genasense-related costs, under the Collaborative Agreement (Note 12), will continue to be recorded as a reduction to research and development expense.
Cash, Cash Equivalents and Short-Term Investments |
Cash and cash equivalents consisted entirely of money market funds. The
carrying amounts of cash, cash equivalents and short-term investments approximate
fair value due to the short-term nature of these instruments. Marketable
short-term investments consisted primarily of corporate notes and government
securities, all of which are classified as available-for-sale marketable
securities. Management determines the appropriate classification of debt
and equity securities at the time of purchase and reassesses the classification
at each reporting date. The Company invests its excess cash primarily in
debt instruments of domestic corporations with AA or greater credit ratings
as defined by Standard & Poors and government backed securities. The
Company has established guidelines relative to diversification and maturities
that attempt to maintain safety and liquidity. These guidelines are periodically
reviewed and modified to take advantage of trends in yields and interest
rates.
F-19
Property and Equipment |
Property and equipment is stated at cost and depreciated on the straight-line method over the estimated useful lives of the assets, ranging from three to five years. Leasehold improvements incurred in the renovation of the Companys current offices are being amortized over the remaining life of the leases. The Companys policy is to evaluate the appropriateness of the carrying value of the undepreciated value of long-lived assets on the basis of estimated future cash flows (undiscounted) and other factors. If such evaluation were to indicate an impairment of these intangible assets, such impairment would be recognized by a write-down of the applicable assets. Since the Company signed a new seven-year lease for additional office space in June 2002, the Companys previous leases for office space have been amended so that the expiration dates coincide with the new lease term.
Intangible Assets |
Intangible assets, consisting primarily of licensed technology and capitalized patent costs, are amortized using the straight-line method over their estimated useful lives of five years. The Companys policy is to evaluate the appropriateness of the carrying values of the unamortized balances of intangible assets on the basis of estimated future cash flows (undiscounted) and other factors. If such evaluation were to indicate an impairment of these assets, such impairment would be recognized by a write-down of the applicable assets. The Company evaluates, each financial reporting period, the continuing value of patents and patent applications. Through this evaluation, the Company may elect to continue to maintain these patents, seek to out-license them, or abandon them.
Income Taxes |
The Company uses the liability method of accounting for income taxes. Deferred
income taxes are determined based on the estimated future tax effects of
differences between the financial statement and tax bases of assets and
liabilities given the provisions of the enacted tax laws.
The Company may record valuation allowances against net deferred tax assets, if based upon the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income and when temporary differences become deductible. The Company considers, among other available information, uncertainties surrounding the recoverability of deferred tax assets, scheduled reversals of deferred tax liabilities, projected future taxable income, and other matters in making this assessment. At December 31, 2002 the Company has reviewed its deferred tax assets and believes that the valuation allowance reduces such assets to an amount that is more likely than not to be realized.
Stock Options |
The Company has two stock-based compensation plans (Note 18). The Company
accounts for stock-based compensation arrangements in accordance with provisions
of Accounting Principles Board (APB) Opinion No. 25, Accounting for
Stock Issued to Employees and complies with the disclosure provisions
of Statement of Financial Accounting Standards (SFAS) No. 123, Accounting
for Stock-Based Compensation. Under APB Opinion No. 25, compensation expense
is based on the difference, if any, on the date of grant, between the fair
value of the Companys stock and the exercise price. The Company accounts
for stock options issued to non-employees in accordance with the provisions
of SFAS No. 123, and Emerging Issues Task Force Consensus on Issue No.
96-18, Accounting for Equity Instruments That Are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or Services.
The Company is amortizing deferred stock compensation using the graded
vesting method, in accordance with Financial Accounting Standards Board
Interpretation No. 28, over the vesting period of each respective option,
which is generally four years.
In December 2002, the FASB issued SFAS No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure Amendment of FASB Statement
No. 123, to provide alternative methods of transition for a voluntary
change to the fair value based method of accounting for stock-based employee
F-20
compensation.
In addition, this Statement amends the disclosure requirements of Statement
No. 123 to require prominent disclosures in both annual and interim financial
statements about the method of accounting for stock-based employee compensation
and the effect of the method used on reported results.
The following table illustrates the effect on net loss and loss per share
if the Company had applied the fair value recognition provisions of SFAS
No. 123 to stock-based employee compensation:
Years
Ended December 31,
|
||||||||||
---|---|---|---|---|---|---|---|---|---|---|
($ thousands, except per share data) | 2002
|
2001
|
2000
|
|||||||
Net loss applicable to common shares, as reported | $ | (74,528) | $ | (46,713 | ) | $ | (15,894 | ) | ||
Add:
Equity related compensation expense included in reported
net income, net of related tax effects |
1,016 | 1,074 | 8,605 | |||||||
Deduct:
Total stock-based employee compensation expense
determined under fair values based method for all awards, net of related tax effects |
6,840 | 5,477 | 4,701 | |||||||
|
|
|
||||||||
Pro forma net loss | $ | (80,352 | ) | $ | (51,116 | ) | $ | (11,990 | ) | |
|
|
|
||||||||
Net loss per share attributable to common shareholders: | ||||||||||
As reported: Basic and diluted | $ | (1.05 | ) | $ | (0.84 | ) | $ | (0.41 | ) | |
Pro forma: Basic and diluted | $ | (1.14 | ) | $ | (0.92 | ) | $ | (0.31 | ) |
Net Loss Per Common Share |
Basic earnings per share are based upon the weighted-average number of
shares outstanding during the period. Diluted earnings per share includes
the weighted average number of all potentially dilutive common shares such
as shares outstanding, options, warrants and convertible preferred stock
outstanding.
Net loss per common share for the three years ended December 31, 2002 is based on the weighted average number of shares of common stock outstanding during the periods. Basic and diluted loss per share are identical for all periods presented as potentially dilutive securities, including options, warrants and convertible preferred stock, aggregating 16.7 million, 17.2 million and 28.3 million in 2002, 2001 and 2000, respectively, have been excluded from the calculation of the diluted net loss per common share because the inclusion of such securities would be antidilutive. Net loss per common share is based on net loss adjusted for imputed and accrued dividends on preferred stock.
Recently Issued Accounting Standards |
In August 2001, the FASB issued SFAS No. 143, Accounting for Asset Retirement
Obligations. SFAS No. 143 addresses financial accounting and reporting
for obligations associated with the retirement of tangible long-lived assets
and the associated asset retirement costs. SFAS No. 143 requires that the
fair value of a liability for an asset retirement obligation be recognized
in the period in which it is incurred if a reasonable estimate of fair
value can be made. The associated asset retirement costs are capitalized
as part of the carrying amount of the long-lived asset. The Company adopted
SFAS No. 143 effective January 1, 2003. The adoption did not have a material
impact on the Companys results of operations, financial position or cash
flows.
In April 2002, the FASB issued SFAS No. 145, Recission of FASB Statements
4, 44 and 64, Amendment of FASB Statement 13, and Technical Corrections.
SFAS No. 145 rescinds the provisions of SFAS No. 4 that requires companies
to classify certain gains and losses from debt extinguishments as extraordinary
items, eliminates the provisions of SFAS No. 44 regarding transition to
the Motor Carrier Act of 1980 and amends the provisions of SFAS No. 13
to require that certain lease modifications be treated as sale leaseback
transactions. The provisions of SFAS No. 145 related to classification
of debt extinguishment are effective for fiscal years beginning after May
15, 2002. Commencing January 1, 2003, the Company will classify debt extinguishment
costs within income from operations. The provisions of SFAS No. 145 related
to lease modifications are effective for transactions occurring after May
15,
F-21
2002. The Company
does not expect the provisions of SFAS No. 145 related to lease modifications
to have a material impact on its financial position or results of operations.
In June 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated
with Exit or Disposal Activities. SFAS No. 146 nullifies Emerging Issues
Task Force (EITF) No. 94-3, Liability Recognition for Certain Employee
Termination Benefits and Other Costs to Exit an Activity (including Certain
Costs Incurred in a Restructuring). The principal difference between SFAS
No. 146 and EITF No. 94-3 relates to its requirements for recognition of
a liability for a cost associated with an exit or disposal activity. SFAS
No. 146 requires that a liability for a cost associated with an exit or
disposal activity be recognized when the liability is incurred. Under EITF
No. 94-3, a liability for an exit cost was recognized at the date of an
entitys commitment to an exit plan. SFAS No. 146 is effective for exit
and disposal activities that are initiated after December 31, 2002. The
Company does not expect the provisions of SFAS No. 146 to have a material
impact on its financial position or results of operations.
In November 2002, FASB Interpretation (FIN) 45, Guarantors Accounting And Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others, was approved by the FASB. FIN 45 clarifies that a guarantor is required to recognize, at the inception of a guarantee, a liability for the fair value of the obligation undertaken in issuing the guarantee. The initial recognition and initial measurement provisions of this interpretation are applicable on a prospective basis to guarantees issued or modified after December 31, 2002. The interpretation also requires enhanced and additional disclosures of guarantees in financial statements ending after December 15, 2002. In the normal course of business, the Company does not issue guarantees, accordingly this interpretation has no effect on the financial statements.
3. | Short-Term Investments |
The carrying amounts of short-term investments approximate fair value due
to the short-term nature of these instruments. The fair value of available-for-sale
marketable securities is as follows ($ thousands):
Amortized
costs |
Unrealized
gains |
Unrealized
losses |
Estimated
fair value |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
December 31, 2002 | ||||||||||||
Corporate debt securities | $ | 80,991 | $ | 42 | $ | (17 | ) | $ | 81,016 | |||
|
|
|
|
|||||||||
December 31, 2001 | ||||||||||||
Corporate debt securities | $ | 16,054 | $ | 23 | $ | (89 | ) | $ | 15,988 | |||
|
|
|
|
|||||||||
The fair value of corporate debt securities by contractual maturity, is
as follows ($ thousands):
December
31,
|
||||||
---|---|---|---|---|---|---|
2002
|
2001
|
|||||
Due in one year or less | $ | 55,979 | $ | 15,988 | ||
Due after one year | 25,037 | - | ||||
|
|
|||||
$ | 81,016 | $ | 15,988 | |||
|
|
The estimated fair value of each marketable security has been compared to its cost, and therefore, an unrealized gain of approximately $0.025 million has been recognized in accumulated other comprehensive income at December 31, 2002.
4. | Accounts Receivable |
Included in accounts receivable and netted against operating expenses in
the consolidated statement of operations at December 31, 2002, is $14.554
million in net expense reimbursements due from Aventis for various third-party
costs, internal costs of scientific and technical personnel (Full-time
Equivalents or
F-22
FTEs) and
Genasense drug supply costs for the three month period ended December 31,
2002. Information with respect to this cost reimbursement is presented
below ($ thousands):
Reimbursement to Genta: | December
31, 2002
|
||
Third-party costs | $ | 10,936 | |
Drug supply costs | 2,254 | ||
FTEs | 1,364 | ||
|
|||
Amount due Genta | $ | 14,554 | |
|
5. | Notes Receivable |
In May 1999, the Company accepted a $1.2 million 7% promissory note (the JBL Note) from Promega as partial consideration for the JBL Agreement (Note 19). The principal of the note plus accrued interest was due as follows: $0.700 million on June 30, 2000 and $0.500 million on the later of June 30, 2000 or the Environmental Compliance Date as defined in the JBL Agreement. Accrued interest due the Company was $0.138 million at December 31, 2000. During the first quarter of 2001, the Company agreed to resolve the matter with Promega, and, in connection therewith, agreed to restructure its $1.2 million promissory note receivable to provide for a $0.2 million non-interest bearing note due upon final resolution of certain environmental issues related to JBL and forgive all accrued interest (Note 19). The transaction resulted in a non-recurring charge of $1.0 million for the quarter ended March 31, 2001. As of March 21, 2003, the Company is awaiting final acceptance by the EPA of the Companys settlement offer before the remaining note receiveable will be repaid by JBL.
6. | Prepaid Expenses and Other Current Assets |
Included in prepaid expenses and other current assets at December 31, 2002,
is $0.834 million for prepaid insurance expenses for various corporate
insurance policies, of which $0.723 million is for directors and officers
liability. After an initial deposit was paid by the Company related to
the insurance policies, the remaining balance was financed and will be
repaid in eight equal installments. At December 31, 2002 the remaining
balance to be paid was $0.490 million.
The remaining amount in prepaid expenses and other current assets is primarily interest due on short-term investments.
7. | Property and Equipment |
Property and equipment is comprised of the following ($ thousands):
Estimated
Useful Lives |
December
31,
|
||||||||
---|---|---|---|---|---|---|---|---|---|
2002
|
2001
|
||||||||
Computer equipment | 3 | $ | 1,734 | $ | 599 | ||||
Software | 3 | 1,237 | 256 | ||||||
Furniture and fixtures | 5 | 920 | 764 | ||||||
Leasehold improvements | 5 | 613 | 523 | ||||||
Equipment | 5 | 80 | 74 | ||||||
|
|
||||||||
4,584 | 2,216 | ||||||||
Less accumulated depreciation and amortization | (1,328 | ) | (368 | ) | |||||
|
|
||||||||
$ | 3,256 | $ | 1,848 | ||||||
|
|
8. | Genta Jago Joint Venture |
Genta Jago Technologies B.V. (Genta Jago) is a joint venture formed by
SkyePharma PLC and Genta. On March 4, 1999, SkyePharma PLC (on behalf of
itself and its affiliates) entered into an interim agreement with Genta
(the Interim JV Agreement) pursuant to which the parties to the joint
venture released each other from all liability relating to unpaid development
costs and funding obligations of
F-23
Genta Jago.
Under the terms of the Interim JV Agreement, SkyePharma PLC assumed responsibility
for substantially all the obligations of the joint venture to third parties
as well as further development of the product line. Pursuant to the terms
of the agreement, earnings of the joint venture are to be allocated equally
between the two parties. Accordingly, Genta recognized $0.502 million as
its equity in net income of the joint venture during the first quarter
of 2000. Since the first quarter of 2000, there have been only $0.033 million
in net earnings of the joint venture allocated to Genta and we are currently
seeking to terminate our involvement with the joint venture.
In 1999, the Company wrote-off its liability in this joint venture and recorded a gain of approximately $2.3 million. Financial statements of the joint venture for the year ended December 31, 2002 and 2001 were not available.
9. | Intangibles |
Intangible assets consist of the following ($ thousands):
December 31,
|
||||||
---|---|---|---|---|---|---|
2002
|
2001
|
|||||
Patent and patent applications | $ | 3,905 | $ | 3,905 | ||
Other amortizable costs | 87 | 87 | ||||
|
|
|||||
3,992 | 3,992 | |||||
Less accumulated amortization | (2,552 | ) | (1,872 | ) | ||
|
|
|||||
$ | 1,440 | $ | 2,120 | |||
|
|
|||||
Future amortization expense related to intangibles at December 31, 2002
are as follows ($ thousands):
Amortization
Expense |
|||
---|---|---|---|
2003 | $ | 577 | |
2004 | 577 | ||
2005 | 286 | ||
2006 | - | ||
2007 | - | ||
Thereafter | - | ||
|
|||
Total | $1,440 | ||
|
|||
10. | Prepaid Royalties |
In December 2000, the Company recorded $1.268 million as the fair value
for its commitment to issue 162,338 shares of common stock to a major university
as consideration for an amendment to a license agreement initially executed
on August 1, 1991 related to antisense technology licensed from the university.
The amendment provided for a reduction in the royalty percentage rate to
be paid to the university based on the volume of sales of the Companys
products containing the antisense technology licensed from such university.
These shares were issued in the first quarter of 2001. The Company will
amortize the prepaid royalties upon the commercialization of Genasense,
the Companys leading antisense drug, through the term of the arrangement
which expires twelve years from the date of first commercial sale.
F-24
11. | Accrued Expenses |
Accrued expenses is comprised of the following ($ thousands):
December
31,
|
|||||||
---|---|---|---|---|---|---|---|
2002 | 2001 | ||||||
|
|||||||
Accrued expenses relating to clinical trials | $ | 910 | $ | 792 | |||
Accrued compensation | 1,826 | 822 | |||||
Accrued interest | 384 | - | |||||
Other accrued costs | 1,620 | 695 | |||||
|
|
||||||
$ | 4,740 | $ | 2,309 | ||||
|
|
12. | Collaborative Agreement |
In April 2002, the Company entered into a development and commercialization
agreement (Collaborative Agreement) with Aventis Pharmaceuticals Inc.
(Aventis). Under the terms of the Collaborative Agreement, the Company
and Aventis will jointly develop and commercialize Genasense in the U.S.
(the Alliance), and Aventis will have exclusive development and marketing
rights to the compound in all countries outside of the U.S. The Company
will retain responsibility for global manufacturing and for regulatory
filings within the U.S., while Aventis will assume all regulatory responsibilities
outside the U.S. Joint management teams, including representatives from
both Genta and Aventis, will oversee the Alliance. Collectively, this Collaborative
Agreement could provide up to $476.9 million in cash, equity and convertible
debt proceeds to the Company. In addition, under the Collaborative Agreement,
Genta is entitled to royalties on any worldwide sales of Genasense, from
which Genta is required to pay third-party pass-through royalties to the
University of Pennsylvania (UPenn) and The National Institutes of Health
(NIH) based on net worldwide sales. Furthermore, under the Collaborative
Agreement, Aventis will pay 75% of U.S. NDA-directed development costs
incurred by either Genta or Aventis subsequent to the execution of the
Collaborative Agreement, and 100% of all other development, marketing,
and sales costs incurred within the U.S. and elsewhere as subject to the
Collaborative Agreement. An analysis of expenses reimbursed under the Collaborative
Agreement follows ($ thousands):
Three
Months Ended
December 31, |
Twelve
Months Ended
December 31, |
|||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2002
|
2001
|
2000
|
2002
|
2001
|
2000
|
|||||||||||||
Research and development expenses, gross | $ | 40,760 | $ | 15,569 | $ | 2,916 | $ | 86,645 | $ | 39,355 | $ | 6,830 | ||||||
Less expense reimbursement | (14,434 | ) | - | - | (27,746 | ) | - | - | ||||||||||
|
|
|
|
|
|
|||||||||||||
Research and development expenses, net | $ | 26,326 | $ | 15,569 | 2,916 | $ | 58,899 | $ | 39,355 | $ | 6,830 | |||||||
|
|
|
|
|
|
|||||||||||||
General and administrative expenses, gross | $ | 4,816 | $ | 2,633 | $ | 596 | $ | 20,052 | $ | 8,215 | $ | 3,323 | ||||||
Less expense reimbursement | (120 | ) | - | - | (705 | ) | - | - | ||||||||||
|
|
|
|
|
|
|||||||||||||
General and administrative expenses, net | $ | 4,696 | $ | 2,633 | $ | 596 | $ | 19,347 | $ | 8,215 | $ | 3,323 | ||||||
|
|
|
|
|
|
As of December 31, 2002, the Company has received a total of $131.9 million
in initial and near-term funding, which included a $10.0 million licensing
fee and $40.0 million in development funding (Note 13), $10.0 million in
convertible debt proceeds (Note 14), and $71.9 million pursuant to an at-market
equity investment in the Companys common stock priced at $10.792 per share.
The remaining amounts that could be received under the Collaborative Agreement,
$280.0 million in cash and $65.0 million in convertible note proceeds,
are contingent upon the achievement of certain research and development
milestones. In connection with this $131.9 million, the Company paid approximately
$1.5 million for financial advisory services and an aggregate of $3.5 million
in one-time pass-through payments to UPenn and the NIH. Neither UPenn nor
the NIH is entitled to any portion of future research and development milestone
payments that Genta may receive.
F-25
13. | Deferred Revenues |
As of December 31, 2002, the Company had recorded $46.591 million, net of amortization in deferred revenues relating to the initial $10.0 million licensing fee and $40.0 million development funding received from Aventis under the Collaborative Agreement (Note 12), of which $5.237 million is included in current liabilities and $41.354 million is classified as long-term deferred revenues, which will be recognized on a straight-line basis over the estimated useful life of the related first-to-expire patent of 115 months, in accordance with SAB 101. Any subsequent milestone payments that may be received from Aventis will also be recognized over the then, remaining estimated useful life of the related first-to-expire patent.
14. | Convertible Debt |
At December 31, 2002, the Company had $10.0 million in convertible debt
that was issued in connection with the Collaborative Agreement (Note 12).
The Company received $10.0 million in debt proceeds from Aventis, and issued
a $10.0 million convertible promissory note to Aventis (Aventis Note).
Interest accrues at the rate of 5.63% per annum until April 26, 2009 (the
Maturity Date) and compounds annually on each anniversary date of the
Aventis Note through the Maturity Date. The Company may redeem the Aventis
Note for cash in whole or in part (together with any accrued and unpaid
interest with respect to such principal amount) in amounts of not less
than $0.5 million (and in $0.1 million increments thereafter). In addition,
the Company may convert the Aventis Note on or prior to the Maturity Date
in whole or in part (together with any accrued and unpaid interest with
respect to such principal amount) in amounts of not less than $5.0 million
(and in $1.0 million increments thereafter), into fully paid and non-assessable
shares of common stock (calculated as to the nearest 1/1000 of a share).
As of any date, the number of shares of common stock into which the Aventis
Note may be converted shall be determined by a formula based on the then
market value of the common stock (the Conversion Price), subject to a
minimum Conversion Price of $8.00 per share.
As of December 31, 2002, the Company has accrued interest of $0.384 million on the Aventis Note.
15. | Income Taxes |
The Companys tax provision is comprised of $0.184 million of current state
taxes related to the New Jersey Alternate Minimum Assessment (AMA) Tax.
Significant components of the Companys deferred tax assets as of December
31, 2002 and 2001 and related valuation reserves are presented below ($
thousands):
December
31, |
||||||
---|---|---|---|---|---|---|
2002
|
2001
|
|||||
Deferred tax assets: | ||||||
Deferred compensation | $ | 6,152 | $ | 5,292 | ||
Net operating loss carryforwards | 68,407 | 53,414 | ||||
Research and development credits | 52,630 | 5,554 | ||||
Purchased technology and license fees | 4,850 | 4,519 | ||||
Depreciation, net | - | 18 | ||||
Deferred revenue | 20,500 | - | ||||
New Jersey Alternate Minimum Assessment (AMA) Tax | 184 | - | ||||
Other, net | 212 | 246 | ||||
|
|
|||||
152,935 | 69,043 | |||||
Valuation allowance for deferred tax assets | (152,775 | ) | (68,999 | ) | ||
|
|
|||||
Net deferred tax assets | 160 | 44 | ||||
Deferred tax liabilities: | ||||||
Patent expenses | - | (44 | ) | |||
|
|
|||||
Depreciation, net | (160 | ) | - | |||
|
|
|||||
(160 | ) | (44 | ) | |||
|
|
|||||
Net deferred tax assets (liabilities) | $ | - | $ | - | ||
|
|
|||||
F-26
A full valuation allowance has been provided at December 31, 2002 and 2001
to reserve for deferred tax assets, as it appears more likely than not
that net deferred tax assets will not be realized.
At December 31, 2002, the Company has federal and state net operating loss
carryforwards of approximately $171.0 million and $95.0 million, respectively.
The difference between the federal and state tax loss carryforwards is
primarily attributable to the fact that the Company relocated from California
to Massachusetts in 1998, and from Massachusetts to New Jersey in 2000.
Net operating losses for state income tax purposes, previously generated
in California and Massachusetts, cannot be utilized in New Jersey. The
federal tax loss carryforwards will begin expiring in 2003, unless previously
utilized. The Company also has federal research and development tax credit
carryforwards of $52.6 million, which will begin expiring in 2003, unless
previously utilized.
Federal and New Jersey tax laws limit the utilization of income tax net operating loss and credit carryforwards that arise prior to certain cumulative changes in a corporations ownership resulting in a change of control of the Company. The Companys future annual utilization of their net operating loss carryforwards and research and development tax credits will be limited due ownership changes which occurred previously.
16. | Operating Leases |
At December 31, 2002 and 2001, the Company maintained $0.507 million and
$0.365 million, respectively, in restricted cash balances with a financial
institution related to lease obligations on its corporate facilities and
leased fleet vehicles. Such restricted cash balances collateralize letters
of credit issued by the financial institution in favor of the Companys
landlord with respect to corporate facilities and GE Capital with respect
to leased fleet vehicles.
Future minimum obligations under operating leases at December 31, 2002
are as follows ($ thousands):
Operating
Leases |
|||
---|---|---|---|
2003 | $ | 2,199 | |
2004 | 2,478 | ||
2005 | 2,476 | ||
2006 | 2,585 | ||
2007 | 2,613 | ||
Thereafter | 5,581 | ||
|
|||
Total | $ | 17,932 | |
|
17. | Stockholders Equity |
Common Stock |
In March 1999, the Company agreed to grant 50,000 shares of common stock
to Georgetown University (the University) as consideration for services
to be performed pursuant to a clinical trials agreement (the Agreement).
According to the terms of the Agreement, the University was to perform
studies of the Companys leading antisense drug, Genasense, on 24 patients,
commencing in April 1999. Pursuant to the terms of the Agreement, Genta
would issue 25,000 of the shares to the University upon the completion
of the first 12 patient studies, with the remaining shares to be issued
upon the completion of the remaining patients. During 2000, the first 12
patient studies were completed.
F-27
Accordingly,
the estimated fair value of these shares of $0.363 million was included
as a charge to non-cash equity related compensation in the amounts of $0.215
million and $0.148 million in 2000 and 1999, respectively. The Company
obtained Board approval in February 2003 for the issuance of the 50,000
shares to the University, which will be issued in March 2003.
In August 1999, the Company acquired Androgenics Technologies, Inc. (Androgenics),
a wholly owned entity of the Companys majority stockholder. Androgenics
is a company with license rights to a series of compounds invented at the
University of Maryland at Baltimore to treat prostate cancer. As consideration
for the acquisition, the Company paid $0.132 million in cash (including
reimbursements of pre-closing expenses and on-going research funding) and
issued warrants (with exercise prices ranging from $1.25 to $2.50 per share)
to purchase an aggregate of 1.0 million shares of common stock, 90% of
which will not become exercisable until the successful conclusion of certain
development milestones, ranging from the initial clinical patient trial
through the submission of an application for marketing authorization. As
of December 31, 2002, the above-mentioned milestones have not been met.
In December 1999, the Company received net proceeds of approximately $10.4
million through the private placement of 114 units (the 1999 Private Placement).
Each unit sold in the 1999 Private Placement consisted of (i) 33,333 shares
of common stock, par value $.001 per share, and (ii) warrants to purchase
8,333 shares of the Companys common stock at any time prior to the fifth
anniversary of the final closing (the Warrants). The Warrants are convertible
at the option of the holder into shares of common stock at an initial conversion
rate equal to $4.83 per share, subject to antidilution adjustment. There
were a total of 3.809 million shares of common stock, and 952,388 warrants
issued in connection with the 1999 Private Placement. The placement agent,
a related party, received cash commissions equal to 7.5% of the gross sales
price, reimbursable expenses up to $0.125 million and warrants (the Placement
Warrants) to purchase up to 10% of the units sold in the private placement
for 110% of the offering price per unit. During 2000, 57,147 penalty warrants
were issued to the 1999 private placement investors as a result of an SEC
registration statement not becoming effective within the prescribed 120
day period after closing.
In January 2000, the Board of Directors approved an amendment to increase
the authorized common stock to 95.0 million shares from 65.0 million. In
May 2000, shareholders approved this amendment at the annual meeting of
stockholders.
In April 2000, the Company entered into an asset purchase agreement with
a privately held corporation and a related party of Genta, in which the
Company acquired all assets, rights and technology to a portfolio of gallium
containing compounds, known as Ganite, in exchange for common stock valued
at $0.084 million. These compounds are used to treat cancer-related hypercalcemia.
In May 2000, the Company entered into a worldwide licensing arrangement
for a broad portfolio of patents and technologies that relate to antisense
for therapeutic and diagnostic applications. The arrangement includes grants
of both exclusive and non-exclusive rights from the licensor to Genta on
a royalty-free basis in return for cash and shares of common stock.
In September 2000, the Company sold 2.163 million shares of common stock
through a private placement and received proceeds of approximately $13.7
million, net of placement costs of $0.916 million. The placement agent
received cash commissions equal to 7.0% of the gross sales price. In connection
with the financing, 135,639 warrants valued at $0.867 million were issued
to the placement agent. In addition, 20,641 penalty warrants were subsequently
issued as a result of untimely filing of an SEC registration statement
within the prescribed 30-day period after closing.
In November 2000, the Company sold 4.285 million shares of common stock
through a private placement and received proceeds of approximately $26.8
million, net of placement costs of $1.633 million. The placement agents,
one a related party shareholder, received cash commissions equal to 7.0%
of the gross sales price.
F-28
In December 2000, the Company recorded $1.268 million as the fair value
for its commitment to issue 162,338 shares of common stock to a major university
as consideration for an amendment to a license agreement initially executed
on August 1, 1991, concerning antisense technology licensed by such university.
The amendment provided for a reduction in the royalty percentage rate to
be paid to the university based on the volume of sales of the Companys
products containing the antisense technology licensed from such university.
These shares were issued in the first quarter of 2001.
In November 2001, the Company sold 2.5 million shares of common stock through
a private placement and received proceeds of approximately $32.2 million,
net of placement agent commissions of $0.420 million and related expenses.
In March 2002, the Board of Directors approved an amendment to increase
the authorized common stock to 120.0 million shares from 95.0 million.
In June 2002, shareholders approved this amendment at the annual meeting
of stockholders.
In May 2002, the Company sold 6.665 million shares of common stock to Aventis in connection with the Collaborative Agreement (Note 12) and received proceeds of $71.0 million, net of investment banking fees of $0.899 million and related expenses.
Treasury Stock |
In June 2002, the Company commenced a stock repurchase program, whereby up to 5.0 million shares of its common stock may be repurchased by the Company at prices deemed desirable by the Company. The Company uses the cost method to account for treasury stock. Since initiating the stock repurchase program, the Company has repurchased a total of 392,700 shares at an average cost of $6.3807 per share.
Preferred Stock |
The Company has authorized 5.0 million shares of preferred stock and has issued and outstanding 260,500 shares of Series A Convertible Preferred Stock as of December 31, 2002. In 1999, the Board of Directors of the Company and certain holders of common stock, Series A and D preferred stock approved, in accordance with Delaware law, an amendment to the Companys Restated Certificate of Incorporation to remove the Fundamental Change redemption right. The Company has formally amended its Restated Certificate of Incorporation after the expiration of the 20-day period provided for in Rule 14c-5 promulgated under the Securities Exchange Act of 1934, as amended (the Exchange Act).
Series A Preferred Stock |
Each share of Series A Preferred Stock is immediately convertible, into
shares of the Companys common stock, at a rate determined by dividing
the aggregate liquidation preference of the Series A Preferred Stock by
the conversion price. The conversion price is subject to adjustment for
antidilution. As of December 31, 2002 and 2001, each share of Series A
Preferred Stock was convertible into 6.8334 and 7.1573 shares of common
stock, respectively.
In the event of a liquidation of the Company, the holders of the Series A Preferred Stock are entitled to a liquidation preference equal to $50 per share, or $13.025 million at December 31, 2002.
Series D Preferred Stock |
In June 1997, the Company received gross proceeds of approximately $16.2
million (approximately $14.0 million net of placement costs) through the
private placement of 161.58 Premium Preferred Units. Each unit sold in
the private placement consisted of (i) 1,000 shares of Premium Preferred
Stock, par value $.001 per share, stated value $100 per share (the Series
D Preferred Stock), and (ii) warrants to purchase 5,000 shares of the
Companys common stock, (the Class D Warrants) at any time prior to the
fifth anniversary of the final closing.
F-29
In May 1998, the Company requested, and subsequently received, consents
(the Letter Agreements) from the holders of a majority of the Series
D Preferred Stock to waive the Companys obligation to use best efforts
to obtain the effectiveness of a registration statement with the SEC as
to common stock issuable upon conversion of Series D Preferred Stock and
exercise of Class D Warrants. In exchange, the Company agreed to waive
the contractual lock-up provisions to which such consenting holders were
subject and which provisions would have prevented the sale of up to 75%
of their securities for a nine-month period following the effectiveness
of the registration statement. The Company also agreed to extend the Reset
Date referred to in the Certificate of Designation of the Series D Preferred
Stock to January 29, 1999 from June 29, 1998. In addition, through the
Letter Agreements, the Company agreed to issue to such holders warrants
to purchase an aggregate of up to 807,900 shares of common stock at $0.94375
per share, subject to certain anti-dilution adjustments, exercisable until
June 29, 2002. The Company had conditioned the effectiveness of such consent
on its acceptance by a majority of the Series D Preferred Stockholders.
In March 2000, the Board of Directors approved the mandatory conversion
of all Series D Convertible Preferred Stock, par value $.001 per share
(Series D Preferred Stock), and the mandatory redemption of all outstanding
Class D Warrants. As a result of the conversion of the Series D Preferred
Stock, the Company issued approximately 14.4 million shares of common stock.
The Company realized approximately $1.4 million from the exercise of the
Class D Warrants and issued 2.0 million shares of common stock. During
2002, the remaining 155,640 Class D Warrants expired and are no longer
redeemable at $0.10 per warrant. No dividends have been accrued after January
29, 2000 due to the mandatory conversion of the Series D Preferred Stock.
Subsequent to the Reset Date of January 29, 1999, Series D Preferred Stock
earned dividends, payable in shares of the Companys common stock, at the
rate of 10% per annum, based on a stated value of $140 per share. In calculating
the number of shares of common stock to be paid with respect to each dividend,
each share of common stock was deemed to have the value of the Conversion
Price at the time such dividend was paid. The Company was restricted from
paying cash dividends on common stock until such time as cumulative dividends
on outstanding shares of Series D Preferred Stock were paid. Additionally,
the Company could not declare a dividend to its common stockholders until
such time that a special dividend of $140 per share was paid on the Series
D Preferred Stock. The Company issued 953,000 and 924,519 shares of common
stock as payment of dividends in 2000 and 1999, respectively. Accordingly,
the Company provided dividends for $5.1 million and $2.3 million for the
years ended December 31, 2000 and 1999, respectively, based on the fair
value of the common stock. As a result of the Mandatory Conversion of Series
D Preferred Stock in June 2000, no further dividends were paid or accrued.
In connection with certain warrants issued in 1998 related to Series D Preferred Stock, the Company was contingently liable for $0.150 million in commissions upon the exercise of the warrants, which were exercised in September 2001, resulting in commissions expense of $0.150 million.
Warrants |
Summary information with respect to outstanding common stock warrants at
December 31, 2002 is presented below:
Exercise
Price
|
Potential
Warrant Exercise Proceeds |
Common
Equivalents |
Expiration
Date
|
|||||
---|---|---|---|---|---|---|---|---|
June 1997 Private Placement (Series D): |
|
|||||||
Placement & Advisory Warrants: | $ | 0.86465-$1.10 | $ | 3,037,995 | 3,355,477 | June 2007 | ||
Androgenics Warrants (August 1999): |
|
|||||||
Vested December 31, 1999: | $ | 1.25 | 121,875 | 97,500 | August 2006 | |||
Vest upon achievement of various |
|
|||||||
milestones: | $ | 1.50-$2.50 | 1,787,500 | 900,000 | August 2004 | |||
December 1999 Private Placement (Common): |
|
|||||||
Related Party Warrants: |
|
|||||||
Common Stock: | $ | 3.30 | 1,060,739 | 321,436 | December 2004 | |||
Warrants: | $ | 5.31 | 426,711 | 80,360 | December 2004 | |||
Funding Warrants: | $ | 4.69716 | 2,629,282 | 559,760 | December 2004 | |||
Penalty Warrants (May 2000): | $ | 4.69716 | 213,791 | 45,515 | May 2005 | |||
September 2000 Private Placement (Common): | ||||||||
Penalty Warrants: | $ | 6.75 | 91,550 | 13,563 | September 2005 | |||
Placement Agent Warrants: | $ | 7.1500 | 310,117 | 43,373 | September 2005 | |||
Placement Agent Warrants: | $ | 7.4250 | 289,330 | 38,967 | September 2005 | |||
November 2000 Private Placement (Common): |
|
|||||||
Placement Agent Warrants: | $ | 7.4250 | . | 429,336 | 57,823 | September 2005 | ||
|
|
|
||||||
$ |
10,398,226
|
5,513,774 | ||||||
|
|
|
||||||
|
F-30
In June 1997, in connection with the issuance of the Premium Preferred
Units, the placement agent received warrants (the Placement Warrants)
to purchase up to 10% of the units sold in the Private Placement for 110%
of the offering price per unit. Furthermore, the Company had entered into
a financial advisory agreement with the placement agent pursuant to which
the financial advisor received certain cash fees and has received warrants
(the Advisory Warrants) to purchase up to 15% of the units sold in the
Private Placement for 110% of the offering price per unit. This financial
advisory agreement terminated in June 1999. The Placement Warrants and
the Advisory Warrants expire on June 29, 2007.
On August 30 1999, the Company acquired Androgenics Technologies, Inc.
(Androgenics), a wholly owned entity of a related party shareholder.
As consideration for the acquisition, the Company paid $0.132 million in
cash (including reimbursements of pre-closing expenses and on-going research
funding) and issued warrants (with exercise prices ranging from $1.25 to
$2.50 per share) to purchase an aggregate of 1.0 million shares of common
stock, 90% of which will not become exercisable until the successful conclusion
of certain development milestones, ranging from the initial clinical patient
trial through the submission of an application for marketing authorization.
The acquisition was accounted for as a transfer of interest between companies
under common control. The cash and warrants were issued in exchange for
100% of the shares of Androgenics and licensed technology and the assumption
of a research and development agreement with the University of Maryland
at Baltimore. The 1.0 million warrants were accounted for as a deemed distribution
based on their fair value of $0.441 million. At December 31, 2002, none
of the above-mentioned milestones have been met and these warrants expire
in August 2004.
On November 5, 1999, the Company issued 550,000 Bridge Warrants to the
Aries Funds in full settlement of the Companys obligation under a 1997
note and warrant purchase agreement. The settlement of this obligation
was accounted for as a capital distribution, since the Aries Funds are
a shareholder of the Company. Accordingly, these warrants were accounted
for at their fair value of $1.8 million and included in accrued dividends
at December 31, 1999. In September 2001, these warrants were exercised
for $0.204 million.
In December 1999, as described above, in connection with the 1999 Private
Placement, the placement agent, a related party shareholder, received warrants
(the Related Party Warrants) to purchase up to 10% of the Units sold
in the Private Placement for 110% of the offering price per Unit. The Related
Party Warrants expire on December 23, 2004. The Related Party Warrants
have a fair value at the time of their issuance approximating $1.377 million,
resulting in no net effect to stockholders equity. During 2001, also in
connection with the 1999 Private Placement, 57,147 penalty warrants were
issued, as a result of an SEC registration statement not becoming effective
within the prescribed 120 day period after closing.
In September 2000, as discussed above, in connection with the September
2000 private equity placement, 135,639 warrants were issued to the placement
agent. The value of such warrants of $0.867 million was considered part
of the cost of the placement. In addition, 20,641 penalty warrants were
issued
F-31
as a result
of an untimely filing of an SEC registration statement within the prescribed
30-day period after closing.
On March 27, 2000, as discussed above, the Board of Directors approved the mandatory redemption of all outstanding Series D Preferred Stock and Class D Warrants.
Common Stock Reserved |
At December 31, 2002, an aggregate of 16,662,202 shares of common stock were reserved for the conversion of preferred stock and the exercise of outstanding options and warrants.
18. | Employee Benefit Plans |
1991 Plan |
The Companys 1991 Stock Plan as amended (the Plan) provides for the
sale of stock and the grant of stock options to employees, directors, consultants
and advisors of the Company. Options may be designated as incentive stock
options or non-statutory stock options; however, incentive stock options
may be granted only to employees of the Company. Options under the Plan
have a term of up to 10 years and must be granted at not less than the
fair market value or 85% of fair market value for non-statutory options
on the date of grant. Common stock sold and options granted pursuant to
the Plan generally vest over a period of four to five years.
Summary information with respect to the Companys 1991 Stock Plan is as
follows:
1991
Plan
|
Shares
Under
Option |
Weighted
Average Exercise Price Per Share |
|||
Balance at January 1, 2000 | 107,568 | $ 4.20 | |||
Granted | - | - | |||
Exercised | - | - | |||
Canceled | (180 | ) | 20.21 | ||
|
|
||||
Balance at December 31, 2000 | 107,388 | 4.18 | |||
Granted | - | - | |||
Exercised | (100,000 | ) | 3.00 | ||
Canceled | (3,000 | ) | 16.67 | ||
|
|
||||
Balance at December 31, 2001 | 4,388 | 22.41 | |||
Granted | - | - | |||
Exercised | - | - | |||
Canceled | - | - | |||
|
|
||||
Balance at December 31, 2002 | 4,388 | $ 22.41 | |||
|
|
At December 31, 2002, all of these outstanding stock options were exercisable. There are no shares of common stock available for grant or sale under the 1991 Stock Plan, as it expired in 2001.
1998 Plan |
Pursuant to the Companys 1998 Stock Plan as amended (the 1998 Plan),
15.6 million shares have been provided for the grant of stock options to
employees, directors, consultants and advisors of the Company. In March
2002, the Board of Directors approved an amendment to increase the total
number of shares of common stock authorized for issuance under the 1998
Plan to 15.6 million shares from 12.1 million. In June 2002, shareholders
approved this amendment at the annual meeting of stockholders. Options
may be designated as incentive stock options or non-statutory stock options;
however, incentive stock options may be granted only to employees of the
Company. Options under the 1998 Plan have a term of up to 10 years and
must be granted at not less than the fair market value, or 85% of fair
market
F-32
value for non-statutory options, on the date of the grant. Common stock sold and options granted pursuant to the 1998 Plan generally vest over a period of four years.
Grants to Employees and Directors - 1998 Plan |
During 1999, the Company granted to certain key employees, including the
new CEO and the Chairman of the Board, a total of 6,188,250 options with
exercise prices below the market value of the Companys common stock on
the date of grant. The Company recorded total deferred compensation of
$2.018 million attributable to the intrinsic value of these options, and
amortized $0.471 million, $0.417 million, and $0.519 million as non-cash
equity related compensation expense in 2002, 2001, and 2000, respectively.
In 2000, the Company recorded additional deferred compensation of $0.064
million for the remeasurement of the new CEOs options, of which $0.013
million, $0.013 million and $0.027 million was amortized as non-cash equity
related compensation expense in 2002, 2001 and 2000, respectively.
During 2000, the Company granted to a certain employee a total of 5,000
options with an exercise price below the market value of the Companys
common stock on the date of grant. The Company recorded total deferred
compensation of $0.032 million attributable to the intrinsic value of these
options, which was amortized as non-cash equity related compensation expense
in 2000. In addition, certain employees were granted a total of 320,000
options that had an exercise price below the market value of the Companys
common stock on the date of hire. Accordingly, the Company recorded total
deferred compensation of $0.934 million attributable to the intrinsic value
of these options, and amortized $0.234 million and $0.293 million as non-cash
equity related compensation expense in 2002 and 2001.
The Companys employees were granted 1,274,400, 1,392,300 and 558,362 stock options with exercise prices equal to fair market value on the date of grant in 2002, 2001 and 2000, respectively.
Grants to Non-Employees - 1998 Plan |
In connection with the JBL Agreement in May 1999 and pursuant to a related
lease termination agreement, the Company granted stock options to acquire
450,000 shares of common stock, to the owners of the building previously
leased to JBL, some of whom were also employees of JBL. Those options are
accounted for pursuant to guidelines in SFAS No. 123, using the Black-Scholes
method and had an approximate value of $1.0 million, which was charged
against the gain on the sale of JBL. In addition, a total of 245,500 options
were granted to employees of JBL upon the closing of the sale of JBL, in
connection with an ongoing service arrangement between Promega and the
Company. These options were accounted for pursuant to SFAS No. 123 using
the Black-Scholes method. The Company recorded $0.529 million and $1.175
million of deferred compensation relative to these JBL options in 2000
and 1999, respectively, and amortized $0.948 million and $0.756 million
as non-cash equity related compensation expense in 2000 and 1999, respectively.
In 1999, the Company also granted 50,000 options to purchase common stock
to certain consultants and advisors to the Company, for which the Company
recorded a total of $0.033 million and $0.136 million in deferred compensation
in 2000 and 1999, respectively, of which $0.069 million and $0.100 million
was amortized as non-cash equity related compensation expense in 2000 and
1999, respectively.
In 2001, the Company also granted 50,000 options to purchase common stock
to members of Gentas Scientific Advisory Board, for which the Company
recorded a total of $3.049 million in deferred compensation, of which $0.297
million and $0.257 million was amortized as non-cash equity related compensation
expense in 2002 and 2001, respectively.
Summary information with respect to the Companys 1998 Stock Plan is as
follows:
F-33
1998
Plan
|
Shares
Under
Option |
Weighted
Average Exercise Price Per Share |
|||
Balance at January 1, 2000 | 9,602,882 | $ 2.08 | |||
Granted | 558,362 | 7.09 | |||
Exercised | (461,067 | ) | 1.81 | ||
Canceled | (3,750 | ) | 2.41 | ||
|
|
||||
Balance at December 31, 2000 | 9,696,427 | 2.39 | |||
Granted | 1,392,300 | 8.56 | |||
Exercised | (2,363,983 | ) | 1.29 | ||
Canceled | (429,500 | ) | 2.94 | ||
|
|
||||
Balance at December 31, 2001 | 8,295,244 | 3.71 | |||
Granted | 1,274,400 | 11.88 | |||
Exercised | (871,632 | ) | 2.12 | ||
Canceled | (198,400 | ) | 11.88 | ||
|
|
||||
Balance at December 31, 2002 | 8,499,612 | $ 4.89 | |||
|
|
||||
At December 31, 2002, options to purchase 5,493,987 shares of common stock were exercisable at a weighted average exercise price of approximately $3.21 per share and 3,359,706 shares of common stock were available for grant or sale under the Plan.
1998 Non-Employee Directors Plan |
Pursuant to the Companys Non-Employee Directors 1998 Stock Plan as amended
(the Directors Plan), 3.3 million shares have been provided for the
grant of stock options to non-employee members of the Board of Directors.
In March 2002, the Board of Directors approved an amendment to increase
the total number of shares of common stock authorized for issuance under
the Directors Plan to 3.3 million shares from 2.9 million and an amendment
to change the amount and the time when stock options are granted under
the Directors Plan. In June 2002, shareholders approved both amendments
at the annual meeting of stockholders. Options under the Directors Plan
have a term of up to ten years and must be granted at not less than the
fair market value on the date of grant. As amended and approved, each director
shall be granted 20,000 options at the first Board of Directors meeting
they attend in person. Each option granted shall become exercisable in
full on the date of grant.
In May 1998, the Company granted stock options to purchase 1,725,000 shares
of common stock, subject to shareholder approval, which was received in
July 1998. As a result of an increase in the stock price between May and
July 1998, the Company recorded deferred compensation of $0.366 million,
of which $0.124 million and $0.153 million was amortized as non-cash equity
related compensation expense in 2000 and 1999, respectively.
In March 2000, four members of the Companys Board of Directors resigned.
The Company accelerated the vesting of their outstanding options and extended
the exercise period for one year. As a result, the Company recognized $6.610
million in non-cash equity related compensation expense.
In March 2000, the Company granted to a Company Director 25,000 options
with an exercise price below the market value of the Companys common stock
on the date of grant. The Company recorded total deferred compensation
of $0.052 million attributable to the intrinsic value of these options,
of which $0.001 million and $0.051 million was amortized as non-cash equity
related compensation expense in 2001 and 2000, respectively.
The Companys directors were granted stock options to purchase a total
of 174,667, 170,769 and 450,000 shares of common stock in 2002, 2001 and
2000, respectively, with an exercise price equal to the fair market value
of the common stock on the date of grant.
Summary information with respect to the Companys 1998 Non-Employee Directors
Plan is as follows:
F-34
1998
Directors Plan
|
Shares
Under
Option |
Weighted
Average Exercise Price Per Share |
|||
---|---|---|---|---|---|
Balance at January 1, 2000 | 2,075,000 | $ 1.26 | |||
Granted | 450,000 | 8.37 | |||
Exercised | (871,887 | ) | 1.17 | ||
Canceled | (32,813 | ) | 0.94 | ||
|
|
||||
Balance at December 31, 2000 | 1,620,300 | 3.30 | |||
Granted | 170,769 | 10.70 | |||
Exercised | (501,400 | ) | 1.33 | ||
Canceled | - | - | |||
|
|
||||
Balance at December 31, 2001 | 1,289,669 | 5.01 | |||
Granted | 174,667 | 11.29 | |||
Exercised | (475,000 | ) | 1.96 | ||
Canceled | (125,000 | ) | 8.77 | ||
|
|
||||
Balance at December 31, 2002 | 864,336 | $ 7.41 | |||
|
|
At December 31, 2002, options granted under the Directors Plan to purchase
771,836 shares of common stock were exercisable at a weighted average exercise
price of approximately $6.86 per share and 1,457,813 shares of common stock
were available for grant or sale under the Directors Plan.
In 2000, a total of 1,008,362 options were granted pursuant to the 1998
Plan and the 1998 Directors Plan, of which 928,362 were granted at fair
market value with a weighted average grant date fair value of $7.76 per
share, and 80,000 were granted below fair market value with a weighted
average grant date fair value of 8.49 per share. In 2001, a total of 1,563,069
options were granted pursuant to the 1998 Plan and the 1998 Directors Plan,
of which 1,513,069 were granted at fair market value with a weighted average
grant date fair value of $8.53 per share, and 50,000 were granted below
fair market value with a weighted average grant date fair value of $6.64
per share. In 2002, a total of 1,449,067 options were granted pursuant
to the 1998 Plan and the 1998 Directors Plan at fair market value with
a weighted average grant date fair value of $11.81 per share. No options
were granted below fair market value.
An analysis of all options outstanding as of December 31, 2002 is presented
below:
Range
of Prices |
Options
Outstanding |
Weighted
Average Remaining Life in Years |
Weighted
Average Exercise Price |
Options
Exercisable |
Weighted
Average Exercise Price of Options Exercisable |
||||||
---|---|---|---|---|---|---|---|---|---|---|---|
$0.88 - $0.94 | 769,000 | 5.96 | $ 0.92 | 769,000 | $ 0.92 | ||||||
$2.41 - $5.92 | 5,398,262 | 7.31 | 4.03 | 4,325,885 | 2.72 | ||||||
$6.03 - $9.92 | 1,898,283 | 8.85 | 7.89 | 904,510 | 7.65 | ||||||
$10.00 - $15.85 | 1,160,401 | 9.00 | 13.02 | 223,926 | 12.26 | ||||||
$16.14 - $25.00 | 142,390 | 7.17 | 18.87 | 46,890 | 18.53 | ||||||
|
|
||||||||||
9,368,336 | 6,270,211 | ||||||||||
|
|
Pro Forma Disclosure |
As permitted under SFAS No. 123, the Company has elected to follow APB
Opinion No. 25 and related interpretations in accounting for stock-based
awards to employees. Pro-forma information regarding net income is required
by SFAS No. 123. This information is required to be determined as if the
Company had accounted for its stock-based awards to employees under the
fair value method of that statement. The fair value of options during the
years ended December 31, 2002, 2001, and 2000, as reported below has been
estimated at the date of grant using the minimum value option pricing model
with the following assumptions:
F-35
Years
Ended December 31,
|
|||||||
---|---|---|---|---|---|---|---|
2002
|
2001
|
2000
|
|||||
Risk-free interest rate | 2.8 | % | 4.0 | % | 6.3 | % | |
Dividend yield | -- | -- | -- | ||||
Expected life (years) | 4.0 | 4.5 | 4.5 | ||||
Volatility | 65 | % | 69 | % | 74 | % |
All of the options issued during 2002 were issued with an exercise price equal to market value on the date of grant. The weighted-average estimated fair value of employee stock options granted during 2002 was $11.81 per share.
Employee Savings Plan |
In January 2001, the Company initiated sponsorship of the Genta Incorporated Savings and Retirement Plan, a defined contribution plan under Section 401(K) of the Internal Revenue Code. The Companys matching contribution to the Plan was $0.343 million and $0.144 million for 2002 and 2001, respectively.
19. | Commitments and Contingencies |
Litigation and Potential Claims |
JBL |
In October 1996, JBL retained a chemical consulting firm to advise it with
respect to an incident of soil and groundwater contamination (the Spill).
Sampling conducted at the JBL facility revealed the presence of chloroform
and perchloroethylenes (PCEs) in the soil and groundwater at this site.
A semi-annual groundwater-monitoring program is being conducted, under
the supervision of the California Regional Water Quality Control Board,
for purposes of determining whether the levels of chloroform and PCEs have
decreased over time. The results of the latest sampling conducted by JBL
show that PCEs and chloroform have decreased in all but one of the monitoring
sites. Based on an estimate provided to the Company by the consulting firm,
the Company accrued $0.065 million in 1999 relating to remedial costs.
Although the Company has agreed to indemnify Promega in respect of this
matter, in November 2001, the Company received from the California Regional
Water Quality Control Board notification on the completion of site investigation
and remedial action for these sites. The notification stated that no further
action related to this case was required.
JBL was notified on October 16, 1998 from Region IX of the Environmental Protection Agency (EPA) that it had been identified as a potentially responsible party (PRP) at the Casmalia Disposal Site, which is located in Santa Barbara, California. JBL has been designated as a de minimis PRP by the EPA. Based on volume amounts from the EPA, the Company concluded that it was probable that a liability had been incurred and accrued $0.075 million during 1998. In 1999, the EPA estimated that the Company would be required to pay approximately $0.063 million to settle their potential liability. In December 2001, Genta received a revised settlement proposal from the EPA in the amount of $0.033 million, the terms of the settlement with the EPA containing standard contribution protection and release language and accordingly, reduced the previous accrual. In January 2002, the Company accepted the proposal and paid the $0.033 million as an offer to settle this matter. There can be no assurance, however, that the EPA will not reject our settlement offer if there is not a sufficient number of PRPs settling with the EPA.
Genta Europe |
During 1995, Genta Pharmaceuticals Europe S.A. (Genta Europe), a wholly-owned
subsidiary of Genta, received funding in the form of a loan from ANVAR,
a French government agency, in the amount of FF5.4 million (or approximately
US$0.863 million at December 31, 2002) with a scheduled maturity of December
31, 2002. Pursuant to the loan agreement with ANVAR, the utilization of
the proceeds was
F-36
intended to
fund research and development activities. In October 1996, in connection
with a restructuring of Gentas operations, Genta terminated all scientific
personnel of Genta Europe. In February 1998, ANVAR asserted that Genta
Europe was not in compliance with the ANVAR Agreement, and that ANVAR might
request immediate repayment of the loan. In July 1998, ANVAR notified Genta
Europe of its demand for accelerated repayment of the loan in the amount
of FF4.2 million (or approximately US$0.671 million at December 31, 2002)
and subsequently notified us that Genta was liable as a guarantor on the
note. At December 31, 2002, the Company has accrued a net liability of
$0.212 million related to the ANVAR Agreement, which management believes
is adequate to provide for that contingency.
In June 1998, Marseille Amenagement, a company affiliated with the city of Marseilles, France, filed suit in France to evict Genta Europe from its facilities in Marseilles and to demand payment of alleged back rent due and of a lease guarantee for nine years rent. Following the filing of this claim and in consideration of the request for repayment of the loan from ANVAR, Genta Europes Board of Directors directed the management to declare a Cessation of Payment. Under this procedure, Genta Europe ceased operations and terminated its only remaining employee. A liquidator was appointed by the Court to take control of any assets of Genta Europe and to make payment to creditors. In December 1998, the Court in Marseilles dismissed the case against Genta Europe and indicated that it had no jurisdiction against Genta Incorporated. In August 1999, Marseille Amenagement instituted legal proceedings against us in the Commercial Court of Marseilles, alleging back rent and early termination receivables aggregating FF2.5 million (or approximately US$0.374 million at September 30, 2002). On October 8, 2001, the Commercial Court of Marseilles rendered their decision which declared the action brought by Marseille Amenagement as admissible and ordered us to pay an amount of FF1.9 million (or approximately US$0.284 million at September 30, 2002). The Company negotiated with Marseille Amenagement and agreed to settle this matter for EUR0.140 million or $0.138 million, which was paid in September 2002. The settlement amount of $0.138 million was recorded as a reduction to the Companys accrued net liability.
University of Pennsylvania |
In October 2002, a licensing officer from the University of Pennsylvania (UPenn) asserted a claim to a portion of the initial $40.0 million development funding (Note 13) the Company received from Aventis pursuant to the Collaborative Agreement. The Company has disputed this claim and has filed a petition for binding arbitration for this matter, as provided in the original licensing agreement between the Company and UPenn. At the current time the Company cannot reasonably estimate the outcome of this claim; however, the Company does not believe that this claim will have a material adverse impact on the Companys financial results and liquidity. As such, the Company has not reserved any amount for royalty payments that could be due to UPenn as a result binding arbitration.
Purchase Commitments |
At December 31, 2002, the Company was obligated for $27.5 million in drug substance purchases during 2003 per an agreement entered into with Avecia Biotechnology, Inc. (Avecia) in December 2002 (the Supply Agreement). Pursuant to the Collaborative Agreement with Aventis (Note 13), the Company anticipates that it will be reimbursed for at least 75% of these purchase commitments after the drug is shipped to the clinical sites. In addition, the Company has committed up to $5.0 million of advance financing to the drug substance manufacturer, for facility expansion, which would be recovered with interest through future payments determined as a function of drug substance purchases to be made by Genta in the future. In 2003, the Company paid $0.392 million in advance financing.
20. | Discontinued Operations |
On March 19, 1999 (the Measurement Date), the Company entered into an
Asset Purchase Agreement (the JBL Agreement) with Promega whereby its
wholly owned subsidiary Promega Biosciences Inc. would acquire substantially
all of the assets and assume certain liabilities of JBL for approximately
$4.8 million in cash, a 7% promissory note for $1.2 million, and certain
pharmaceutical development services in support of the Companys development
activities. The transaction was
F-37
completed on
May 10, 1999 (the Disposal Date), with a gain on the sale of approximately
$1.6 million being recognized, based upon the purchase price of JBL, less
its net assets and costs and expenses associated with the sale, including
lease termination costs of $1.1 million, JBL losses of $0.147 million,
and legal, accounting, tax and other miscellaneous costs of the sale approximating
$0.653 million.
In connection with the JBL Agreement (Note 18), the Company granted stock options during 1999 to acquire 450,000 shares of common stock, to owners of the building previously leased to JBL, some of whom were JBL employees. These options were accounted for pursuant to the Black-Scholes option-pricing model and had an approximate value of $1.0 million, which was charged against the gain on the sale of JBL. In addition, 245,500 options were granted to former employees of JBL in connection with an ongoing service arrangement between Promega and the Company. The fair value of these options amounting to $1.7 million was charged to continuing operations as non-cash equity related compensation expense in the amount of $0.948 million and $0.757 million for the years ended December 31, 2000 and 1999, respectively.
21. | Subsequent Events |
In March 2003, the Company and Aventis signed an amendment to the Collaborative Agreement (Note 12), which establishes a line of credit, up to $40.0 million, related to the development, manufacturing and commercialization of Genasense.
22. | Selected Quarterly Financial Data (Unaudited) |
Quarter
Ended
|
|||||||||
---|---|---|---|---|---|---|---|---|---|
Mar. 31
|
Jun. 30
|
Sep. 30
|
Dec. 31
|
||||||
2002
($ thousands, except per share data) |
|||||||||
Revenues | $ 5 | $ 910 | $ 1,325 | $ 1,319 | |||||
Operating expenses (1) | 12,639 | 17,940 | 16,646 | 31,021 | |||||
Loss from continuing operations | (12,626 | ) | (17,069 | ) | (15,112 | ) | (29,721 | ) | |
Net loss | (12,626 | ) | (17,069 | ) | (15,112 | ) | (29,721 | ) | |
Loss per common share from continuing operations: | |||||||||
Basic and diluted | $ (0.19 | ) | $ (0.25 | ) | $ (0.21 | ) | $ (0.40 | ) | |
Net loss per common share: | |||||||||
Basic and diluted | $ (0.19 | ) | $ (0.25 | ) | $ (0.21 | ) | $ (0.40 | ) |
Mar. 31
|
Jun. 30
|
Sep. 30
|
Dec. 31
|
||||||
---|---|---|---|---|---|---|---|---|---|
2001
($ thousands, except per share data) |
|||||||||
Revenues | $ 70 | $ 12 | $ 23 | $ 41 | |||||
Operating expenses (2) | 7,028 | 11,129 | 11,210 | 18,203 | |||||
Loss from continuing operations | (7,459 | ) | (10,903 | ) | (10,420 | ) | (17,931 | ) | |
Net loss | (7,459 | ) | (10,903 | ) | (10,420 | ) | (17,931 | ) | |
Loss per common share from continuing operations: | |||||||||
Basic and diluted | $(0.15 | ) | $ (0.21 | ) | $ (0.19 | ) | $ (0.29 | ) | |
Net loss per common share: | |||||||||
Basic and diluted | $(0.15 | ) | $ (0.21 | ) | $ (0.19 | ) | $ (0.29 | ) |
(1) | Excludes equity related compensation expense |
(2) | Excludes equity related compensation expense and Promega settlement expense (Note 5) |
F-38
23. | Supplemental disclosure of cash flows information and non-cash investing and financing activities |
Years
Ended December 31,
|
|||||||||
---|---|---|---|---|---|---|---|---|---|
($ thousands) | 2002
|
2001
|
2000
|
||||||
Preferred stock dividend accrued | $ | - | $ | - | $ | 3,443 | |||
Common stock issued in payment of dividends on preferred stock | - | - | 8,577 | ||||||
Common stock issued in payment of patent portfolios | - | - | 2,484 | ||||||
Income receivable on securities to be sold | - | (3 | ) | 64 | |||||
Market value change on short-term investments | 91 | (97 | ) | 31 | |||||
Stock warrants issued to placement agent | - | - | 867 | ||||||
Common stock to be issued in payment of future royalties | - | - | 1,268 | ||||||
Common stock issued in payment of hiring bonus | - | 50 | - |
Interest paid during the year ended December 31, 2000 was $0.036 million.
No interest was paid in the years ended December 31, 2002 and 2001.
F-39
Genta Incorporated
Unaudited
Condensed Consolidated
Pro Forma
Financial Information
The following
unaudited condensed consolidated pro forma financial statements have been
prepared to give effect to Genta Incorporateds (Genta) acquisition of
Salus Therapeutics, Inc. (Salus). These pro forma statements are presented
for illustrative purposes only.
The pro forma
adjustments are based upon available information and assumptions that Genta
believes are reasonable. A preliminary allocation of the purchase price
for the above transaction has not been completed. A determination of the
fair value of the underlying assets acquired and liabilities assumed is
in process. It is expected that a significant portion of the allocation
will be made to in-process research and development, which will be expensed
upon recognition. The unaudited condensed consolidated pro forma financial
statements do not purport to represent what the consolidated results of
operations or financial position of Genta would actually have been if the
acquisition had occurred on the dates referred to below, nor do they purport
to project the results of operations or financial position of Genta for
any future period.
The unaudited
condensed consolidated pro forma balance sheet as of June 30, 2003 was
prepared by combining the historical cost balance sheet at June 30, 2003
of Genta with the historical cost balance sheet for Salus at June 30, 2003
giving effect to the acquisition as though it was completed on that date.
The unaudited
condensed consolidated pro forma statements of operations for the year
ended December 31, 2002 and for the six month period ended June 30, 2003
were prepared by combining Gentas statement of operations for the respective
periods with Salus statement of operations for the similar respective
periods, giving effect to the acquisition as though it occurred on the
first day of the respective fiscal year.
These unaudited
condensed consolidated pro forma statements of operations do not give effect
to any restructuring costs or any potential cost savings or other operating
efficiencies that could result from the acquisition, or any non-recurring
charges or credits resulting from the transaction such as in-process research
and development charges.
The unaudited
condensed consolidated pro forma financial statements should be read in
conjunction with the historical financial statements of (i) Genta included
in its Annual Report on Form 10-K for the year ended December 31, 2002
(filed March 31, 2003), and (ii) Salus beginning on page F-51 hereof.
F-40
Unaudited
Condensed Consolidated Pro Forma Balance Sheet
June 30,
2003
(In thousands,
except per share data)
June
30, 2003 |
||||||||||||
Genta
|
Salus
|
Adjustments
|
Pro
Forma |
|||||||||
(a) | (b) | |||||||||||
ASSETS | ||||||||||||
Current assets | ||||||||||||
Cash and cash equivalents | $ | 38,915 | $ | 92 | $ | - | $ | 39,007 | ||||
Short-term investments | 58,274 | - | - | 58,274 | ||||||||
Accounts receivable | 19,585 | 1 | - | 19,586 | ||||||||
Notes receivable | 275 | - | - | 275 | ||||||||
Prepaid expenses and other current assets | 2,123 | - | - | 2,123 | ||||||||
Unallocated purchase price | - | - | 12,985 | (c) | 12,985 | |||||||
|
|
|
|
|||||||||
Total current assets | 119,172 | 93 | 12,985 | 132,250 | ||||||||
Property and equipment, net | 3,565 | 197 | - | 3,762 | ||||||||
Intangible assets, net | 1,151 | - | - | 1,151 | ||||||||
Notes receivable | 1,465 | - | - | 1,465 | ||||||||
Deposits and other assets | 1,716 | 6 | 1,722 | |||||||||
|
|
|
|
|||||||||
Total assets | $ | 127,069 | $ | 296 | $ | 12,985 | $ | 140,350 | ||||
|
|
|
|
|||||||||
LIABILITIES & STOCKHOLDERS EQUITY | ||||||||||||
Current liabilities | ||||||||||||
Accounts payable | $ | 5,093 | $ | 58 | $ | - | $ | 5,151 | ||||
Subordinated notes payable | - | 375 | - | 375 | ||||||||
Accrued expenses | 7,372 | 80 | - | 7,452 | ||||||||
Deferred revenues, current portion | 5,237 | - | - | 5,237 | ||||||||
Other current liabilities | 212 | 4 | - | 216 | ||||||||
|
|
|
|
|||||||||
Total current liabilities | 17,914 | 517 | - | 18,431 | ||||||||
Deferred revenues | 38,736 | - | - | 38,736 | ||||||||
Line of credit | 25,000 | - | - | 25,000 | ||||||||
Convertible debt | 10,000 | - | - | 10,000 | ||||||||
|
|
|
|
|||||||||
Total liabilities | 91,650 | 517 | - | 92,167 | ||||||||
|
|
|
|
|||||||||
Commitments and contingencies | ||||||||||||
Series A convertible preferred stock, $.001 par | ||||||||||||
value; 600 shares authorized, 261 shares | ||||||||||||
issued and outstanding (aggregate | ||||||||||||
liquidation preference of $13,025) | - | - | - | - |
F-41
Unaudited
Condensed Consolidated Pro Forma Balance Sheet
June 30,
2003
(In thousands,
except per share data)
June
30, 2003 |
|||||||||||||
Genta
|
Salus
|
Adjustments
|
Pro
Forma |
||||||||||
Series
A redeemable convertible preferred stock, $.005 par value; 2,000 shares authorized, issued and outstanding (aggregate liquidation preference of $1,000) |
- | 1,000 | (1,000 | ) | (d) | - | |||||||
Series
B redeemable convertible preferred stock, $.005 par value; 6,775 shares authorized, 5,049 issued and outstanding (aggregate liquidation preference of $5,049) |
- | 2,402 | (2,402 | ) | (d) | - | |||||||
STOCKHOLDERS EQUITY | |||||||||||||
Common
stock, $.001 par value; 120,000 shares authorized, 74,853 shares issued and 74,409 shares outstanding |
75 | - | 1 | (c) | 76 | ||||||||
Common
stock, $.005 par value, 17,000 shares authorized, 5,000 shares issued and outstanding |
- | 25 | (25 | ) | (d) | - | |||||||
Deferred compensation | (409 | ) | - | - | (409 | ) | |||||||
Additional paid-in capital | 324,792 | 73 | 12,690 | 337,555 | |||||||||
Accumulated deficit | (286,211 | ) | (3,721 | ) | 3,721 | (d) | (286,211 | ) | |||||
Accumulated other comprehensive income | (19 | ) | - | - | (19 | ) | |||||||
|
|
|
|
||||||||||
Less cost of treasury stock: 393 shares | (2,809 | ) | - | - | (2,809 | ) | |||||||
|
|
|
|
||||||||||
35,419 | (3,623 | ) | 16,387 | 48,183 | |||||||||
|
|
|
|
||||||||||
Total liabilities and stockholders equity | $ | 127,069 | $ | 296 | $ | 12,985 | $ | 140,350 | |||||
|
|
|
|
F-42
Unaudited
Condensed Consolidated Pro Forma Statement of Operations
Six Months
Ended June 30, 2003
(Dollars
in thousands, except per share data)
Six
Months Ended June 30, 2003
|
||||||||||||||
Genta
|
Salus
|
Adjustments
|
Pro
Forma
|
|||||||||||
(e) | (f) | |||||||||||||
Revenues: | ||||||||||||||
License and royalties fees | $ | 542 | $ | - | $ | - | $ | 542 | ||||||
Development funding | 2,087 | 174 | - | 2,261 | ||||||||||
|
|
|
|
|||||||||||
Total revenues | 2,629 | 174 | - | 2,803 | ||||||||||
Cost and expenses: | ||||||||||||||
Research and development | 4,978 | 511 | - | 5,489 | ||||||||||
General and administrative | 10,911 | 348 | - | 11,259 | ||||||||||
Equity related compensation | 288 | - | - | 288 | ||||||||||
|
|
|
|
|||||||||||
Total operating expenses | 16,177 | 859 | - | 17,036 | ||||||||||
|
|
|
|
|||||||||||
Loss from operations | (13,548 | ) | (685 | ) | - | (14,233 | ) | |||||||
Other income, principally net interest income | 527 | (4 | ) | - | 523 | |||||||||
|
|
|
|
|||||||||||
Net loss | $ | (13,021 | ) | $ | (689 | ) | $ | - | $ | (13,710 | ) | |||
|
|
|
|
|||||||||||
Net loss per common share | $ | (0.18 | ) | $ | (0.18 | ) | ||||||||
|
|
|||||||||||||
Shares used in computing net loss per common share | 74,338 | 75,338 | ||||||||||||
|
|
See notes to unaudited
condensed consolidated pro forma financial statements
F-43
Unaudited
Condensed Consolidated Pro Forma Statement of Operations
Year Ended
December 31, 2002
(Dollars
in thousands, except per share data)
Year
Ended December 31, 2002
|
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Genta
|
Salus
|
Adjustments
|
Pro
Forma
|
|||||||||
Revenues: | (e) | (f) | ||||||||||
License and royalties fees | $ | 61 | $ | - | $ | - | $ | 61 | ||||
Development funding | 3,498 | 386 | - | 3,884 | ||||||||
|
|
|
|
|||||||||
Total revenues | 3,559 | 386 | - | 3,945 | ||||||||
Cost and expenses: | ||||||||||||
Research and development | 58,899 | 854 | - | 59,753 | ||||||||
General and administrative | 19,347 | 675 | - | 20,022 | ||||||||
Equity related compensation | 1,016 | - | - | 1,016 | ||||||||
|
|
|
|
|||||||||
Total operating expenses | 79,262 | 1,529 | - | 80,791 | ||||||||
|
|
|
|
|||||||||
Loss from operations | (75,703 | ) | (1,143 | ) | - | (76,846 | ) | |||||
Equity in net income of joint venture | 33 | - | - | 33 | ||||||||
Other income, principally net interest income | 1,326 | (50 | ) | - | 1,276 | |||||||
Income taxes | (184 | ) | - | - | (184 | ) | ||||||
|
|
|
|
|||||||||
Net loss | $ | (74,528 | ) | $ | (1,193 | ) | $ | - | $ | (75,721 | ) | |
|
|
|
|
|||||||||
Net loss per common share | $ | (1.05 | ) | $ | (1.06 | ) | ||||||
|
|
|||||||||||
Shares used in computing net loss per common | ||||||||||||
share | 70,656 | 71,656 | ||||||||||
|
|
See notes to unaudited
condensed consolidated pro forma financial statements
F-44
Genta Incorporated
Notes to
Unaudited Condensed Consolidated Pro Forma Financial Statements
1. | Basis of Pro Forma Presentation |
On August 21,
2003 (the Closing Date), Genta Incorporated (Genta) acquired Salus
Therapeutics, Inc. (Salus) pursuant to a merger agreement between Salus
and Genta (the Acquisition).
As of the Closing Date,
Genta issued approximately 1 million shares of its common stock with a fair
value of approximately $13 million to Salus stockholders in exchange for all
of the outstanding shares of Salus common stock, including those issued pursuant
to the conversion of Salus preferred stock. Approximately thirty-five
percent of the initial payment is held in escrow and will be released on the
first anniversary of the Acquisition, assuming no events of default occur as
described in the merger agreement. Contingent upon the achievement of certain
preclinical and clinical milestones, an additional $17.0 million dollars may
be paid on stock or cash at Gentas option.
The effects of the Acquisition have been presented using the purchase method of accounting, in accordance with accounting principles generally accepted in the United States of America. A preliminary allocation of the purchase price for the above transaction has not been completed. A determination of the fair value of the underlying assets acquired and liabilities assumed is in process. It is expected that a significant portion of the allocation will be made to in-process research and development, which will be expensed upon recognition.
2. | Balance Sheet Adjustments |
(a) | Represents the historical balance sheet of Genta. |
(b) | Represents the historical balance sheet of Salus. |
(c) | To reflect the issuance by Genta of approximately 1 million shares of its common stock with a fair value of approximately $13.0 million to Salus stockholders. |
(d) | To reflect the write-off of Salus common and preferred stock as they were exchanged for shares of Genta common stock at the time of acquisition. To reflect the write-off of Salus accumulated deficit. | |
(e) | Represents the historical results of operations of Genta for the periods presented. |
(f) | Represents the pre-acquisition results of operations of Salus for the periods presented. |
F-45
SALUS THERAPEUTICS,
INC.
UNAUDITED
CONDENSED BALANCE SHEET
JUNE 30,
2003
2003
|
|||
---|---|---|---|
ASSETS | |||
CURRENT ASSETS: | |||
Cash | $ | 91,980 | |
Accounts receivable | 535 | ||
|
|||
Total current assets | 92,515 | ||
|
|||
PROPERTY AND EQUIPMENT - At cost: | |||
Equipment | 336,875 | ||
Furniture and fixtures | 123,165 | ||
Software | 7,836 | ||
Leasehold improvements | 201,186 | ||
|
|||
669,062 | |||
Less accumulated depreciation and amortization | (472,188 | ) | |
|
|||
196,874 | |||
OTHER ASSETS | 6,475 | ||
|
|||
TOTAL ASSETS | $ | 295,864 | |
|
|||
LIABILITIES AND STOCKHOLDERS EQUITY | |||
CURRENT LIABILITIES: | |||
Accounts payable | $ | 58,138 | |
Accrued expenses | 79,596 | ||
Subordinated notes payable | 375,000 | ||
Interest payable | 4,438 | ||
|
|||
Total current liabilities | 517,172 | ||
|
|||
COMMITMENTS (Note 3) | |||
SERIES A REDEEMABLE CONVERTIBLE PREFERRED STOCK, $.005 par value ($1,000,000 | |||
liquidation preference), 2,000,000 shares authorized, issued and outstanding as of | |||
June 30, 2003 | 1,000,000 | ||
SERIES B REDEEMABLE CONVERTIBLE PREFERRED STOCK, $.005 par value ($5,048,604 | |||
liquidation preference), 6,775,333 shares authorized and 5,048,604 shares issued | |||
and outstanding as of June 30, 2003 | 2,401,545 | ||
STOCKHOLDERS EQUITY: | |||
Common stock, $.005 par value, 17,000,000 shares authorized and 5,000,000 shares | |||
issued and outstanding as of June 30, 2003 | 25,000 | ||
Deferred compensation | (27 | ) | |
Additional paid-in capital | 73,141 | ||
Accumulated deficit | (3,720,967 | ) | |
|
|||
Total stockholders equity | (3,622,853 | ) | |
|
|||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY | $ | 295,864 | |
|
See notes to
unaudited condensed financial statements.
F-46
SALUS THERAPEUTICS,
INC.
UNAUDITED
CONDENSED STATEMENTS OF OPERATIONS
SIX MONTHS
ENDED JUNE 30, 2003 AND 2002
2003
|
2002
|
|||||
---|---|---|---|---|---|---|
REVENUES GRANTS | $ | 174,000 | $ | 209,400 | ||
|
|
|||||
OPERATING EXPENSES: | ||||||
Research and development | 511,218 | 361,646 | ||||
General and administrative | 347,808 | 312,852 | ||||
|
|
|||||
Total operating expenses | 859,026 | 674,498 | ||||
|
|
|||||
LOSS FROM OPERATIONS | (685,026 | ) | (465,098 | ) | ||
|
|
|||||
OTHER INCOME/(EXPENSE): | ||||||
Interest income | 419 | 330 | ||||
Interest expense | (4,731 | ) | (48,805 | ) | ||
|
|
|||||
Total other income/(expense) | (4,312 | ) | (48,475 | ) | ||
|
|
|||||
NET LOSS | (689,338 | ) | (513,573 | ) | ||
Accretion of Series B redeemable convertible preferred stock to | ||||||
liquidation value | (330,882 | ) | - | |||
|
|
|||||
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (1,020,220 | ) | $ | (513,573 | ) |
|
|
See notes to
unaudited condensed financial statements.
F-47
Salus Therapeutics,
Inc.
STATEMENT OF CASH
FLOWS
SIX MONTHS ENDED
JUNE 30, 2003
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ | (689,338) | |
Adjustments to reconcile net loss to net cash used | |||
in operating activities: | |||
Depreciation and amortization | 60,598 | ||
Amortization of deferred compensation expense | 5 | ||
(Increase) decrease in assets: | |||
Prepaid expenses | 15,085 | ||
Accounts receivable | (535) | ||
Increase (decrease) in liabilities: | |||
Accounts payable | 39,926 | ||
Accrued expenses | 51,133 | ||
Interest payable | 4,438 | ||
|
|||
Net cash used in operating activities | (518,688) | ||
|
|||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Capital expenditures | (14,544) | ||
|
|||
Net cash provided by investing activities | (14,544) | ||
|
|||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Borrowings under subordinated notes | 375,000 | ||
Repayments under capital lease obligations | (22,525) | ||
|
|||
Net cash provided by financing activities | 352,475 | ||
|
|||
NET DECREASE IN CASH | (180,757) | ||
CASH, BEGINNING OF PERIOD | 272,737 | ||
|
|||
CASH, END OF PERIOD | $ | 91,980 | |
|
|||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||
Cash paid during the period for: | |||
Interest | $ | 4,731 | |
|
|||
Income taxes | $ | | |
|
See notes to unaudited condensed financial statements.
F-48
Salus Therapeutics,
Inc.
NOTES TO UNAUDITED
CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2003
(1) | Basis of Presentation |
The unaudited condensed financial statements of Salus Therapeutics, Inc.,
a Delaware corporation (Salus or the Company), presented herein have
been prepared in accordance with accounting principles generally accepted
in the United States of America for interim financial information. Accordingly,
they do not include all of the information and note disclosures required
to be presented for complete financial statements. The accompanying financial
statements reflect all adjustments (consisting only of normal recurring
accruals), which are, in the opinion of management, necessary for a fair
presentation of the results for the interim periods presented.
The unaudited condensed financial statements and related disclosures have been prepared with the presumption that users of the interim financial information have read or have access to the audited financial statements for the preceding fiscal year. Accordingly, these financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Companys annual financial statements for the fiscal year ended December 31, 2002. Results for the interim periods are not necessarily indicative of results for the full years.
Revenue Recognition |
Grant revenues are generated by grants from the National Institutes of Health. Grant revenue is recorded by the Company as it is earned under the terms of the agreement. As of June 30, 2003, the Company is recognizing revenue under a grant that expires in July 2003.
Research and Development |
All expenditures for research and development are charged to expense as incurred.
Stock Options |
The Company accounts for stock-based compensation arrangements in accordance
with the provisions of Accounting Principles Board (APB) Opinion No.
25, Accounting for Stock Issued to Employees and complies with the
disclosure provisions of Statement of Financial Accounting Standards (SFAS)
No. 123, Accounting for Stock-Based Compensation. Under APB Opinion
No. 25, compensation expense is based on the difference, if any, on the
date of grant, between the fair value of the Companys stock and the exercise
price. The Company accounts for stock options issued to non-employees in
accordance with the provisions of SFAS No. 123, and Emerging Issues Task
Force Consensus on Issue No. 96-18, Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction
with Selling, Goods or Services. The Company is amortizing deferred
stock compensation using the graded vesting method, in accordance with
Financial Accounting Standards Board Interpretation No. 28, over the vesting
period of each respective option, which is generally four years.
In December 2002, the Financial Accounting Standards Board (FASB) issued
SFAS No. 148, Accounting for Stock-Based Compensation Transition and
Disclosure Amendment of FASB Statement No. 123, to provide alternative
methods of transition for a voluntary change to the fair value based method
of accounting for stock-based employee compensation. In addition, this
Statement amends the disclosure requirements of Statement No. 123 to require
prominent disclosures in both annual and interim financial statements about
the method of accounting for stock-based employee compensation and the
effect of the method used on reported results.
F-49
The following table illustrates the effect on net loss and loss per share
if the Company had applied the fair value recognition provisions of SFAS
No. 123 to stock-based employee compensation:
Six
Months Ended June 30,
|
||||||
---|---|---|---|---|---|---|
2003
|
2002
|
|||||
Net loss, as reported | $ | (689,338 | ) | $ | (513,573 | ) |
Equity related employee compensation expense included in | ||||||
reported net loss, net of related tax effects | 5 | - | ||||
Total stock-based employee compensation expense determined | ||||||
under fair values based method for all awards, net of | ||||||
related tax effects | (1,512 | ) | (1,299 | ) | ||
|
|
|||||
Pro forma net loss | $ | (690,845 | ) | $ | (514,872 | ) |
|
|
Pro Forma Disclosure |
The fair value of options for the six months ended June 30, 2003 and 2002
has been estimated at the date of grant using the minimum value option
pricing model with the following assumptions:
Six
Months Ended June 30,
|
|||||
---|---|---|---|---|---|
2003
|
2002
|
||||
Risk-free interest rate | 3.01 | % | 4.66 | % | |
Dividend yield | -- | -- | |||
Expected life (years) | 5.0 | 5.0 | |||
Volatility | 0.0 | % | 0.0 | % |
All of the options issued during the six-month periods ended June 30, 2003 and 2002, were issued with an exercise price equal to market value on the date of grant. The weighted-average estimated fair value of stock options granted was $0.01 per share for the six-month periods ended June 30, 2003 and 2002.
Recent Accounting Pronouncements |
In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of Liabilities, Equity, or Both. This limited scope statement prescribes changes to the classification of certain financial instruments including preferred securities issued in the form of shares that are mandatorily redeemable; that embody an unconditional obligation requiring the issuer to redeem them by transferring its assets at a specified or determinable date (or dates) or upon an event that is certain to occur. This Statement is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003. The Company has not completed the process of evaluating the impact that will result from the adoption of this statement and is therefore unable to disclose the impact the adoption will have on its financial position and results of operations.
In April 2003, the FASB issued SFAS No. 149, Amendment of Statement
133 on Derivative Instruments and Hedging Activities. SFAS No. 149
amends and clarifies financial accounting and reporting for derivative
instruments, including certain derivative instruments embedded in other
contracts (collectively referred to as derivatives) and for hedging activities
under SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities. In particular, SFAS No. 149 (1) clarifies under what circumstances
a contract with an initial net investment meets the characteristic of a
derivative discussed in paragraph 6(b) of SFAS No. 133, (2) clarifies when
a derivative contains a financing component, (3) amends the definition
of an underlying to conform it to language used in FIN 45, Guarantors
Accounting and Disclosure Requirements for Guarantees, Including Indirect
Guarantees of Indebtedness of Others,
F-50
and (4) amends
certain other existing pronouncements. SFAS No. 149 is to be applied prospectively
to contracts entered into or modified after June 30, 2003, with certain
exceptions, and for hedging relationships designated after June 30, 2003.
The Company believes that adopting this statement will not have a material
impact on the Companys results of operations, financial position or cash
flows.
In January 2003, the FASB issued Interpretation No. (FIN) 46, Consolidation of Variable Interest Entities. The Company has no arrangements that would be subject to this interpretation.
(2) | Subordinated Notes Payable |
In May 2003, a Series B stockholder loaned $125,000 to the Company in the
form of a short-term subordinated convertible promissory note. The note
bears interest at 8.0 percent and is due on May 6, 2004. On August 21,
2003, this note was converted into Series B redeemable convertible preferred
stock and ultimately exchanged for Genta common stock as a result of the
acquisition described in Note 4.
In April 2003 and June 2003, a Series B stockholder loaned $250,000 to the Company in the form of a short-term subordinated convertible promissory note. The note bears interest at 8.0 percent and is due on July 2, 2003 and September 10, 2003, respectively. On August 21, 2003, this note was converted into Series B redeemable convertible preferred stock and ultimately exchanged for Genta common stock as a result of the acquisition described in Note 4.
(3) | Commitments and Contingencies |
In August 2003, the Company entered into a new lease agreement for office space totaling 11,178 square feet of space, at a rental cost of approximately $199,000 per year. The lease shall be for a period of five full lease years ending November 30, 2008. The Company will also be responsible for the tenants pro rata share of operating expenses.
(4) | Subsequent Event |
On August 21, 2003, the Company was acquired by Genta Incorporated, a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer, located in Berkeley Heights, New Jersey. Under the terms of the merger agreement, Genta issued approximately 1 million shares of its common stock with a fair value of approximately $13 million to Salus stockholders in exchange for all of the outstanding shares of Salus common stock, including those issued pursuant to the conversion of Salus preferred stock. Approximately thirty-five percent of the initial payment is held in escrow and will be released on the first anniversary of the acquisition, assuming no events of default occur as described in the merger agreement. Contingent upon the achievement of certain preclinical and clinical milestones, an additional $17 million may be paid in stock or cash at Gentas option.
F-51
INDEPENDENT
AUDITORS REPORT
To the Board
of Directors
Salus Therapeutics,
Inc.
We have audited
the accompanying balance sheet of Salus Therapeutics, Inc. (the Company)
as of December 31, 2002, and the related statements of operations, cash
flows and of changes in stockholders equity for the year then ended. These
financial statements are the responsibility of the Companys management.
Our responsibility is to express an opinion on these financial statements
based on our audit.
We conducted
our audit in accordance with auditing standards generally accepted in the
United States of America. Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement. An audit includes examining, on a test
basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that our audit
provides a reasonable basis for our opinion.
In our opinion,
such financial statements present fairly, in all material respects, the
financial position of Salus Therapeutics, Inc. at December 31, 2002, and
the results of its operations and its cash flows for the year then ended
in conformity with accounting principles generally accepted in the United
States of America.
/s/ DELOITTE & TOUCHE LLP
October 23,
2003
F-52
SALUS THERAPEUTICS,
INC.
BALANCE
SHEET
DECEMBER
31, 2002
ASSETS | |||
CURRENT ASSETS: | |||
Cash | $ | 272,737 | |
Prepaid expenses | 15,085 | ||
|
|||
Total current assets | 287,822 | ||
|
|||
PROPERTY AND EQUIPMENT - At cost: | |||
Equipment | 327,035 | ||
Furniture and fixtures | 118,407 | ||
Software | 7,836 | ||
Leasehold improvements | 201,186 | ||
|
|||
654,464 | |||
Less accumulated depreciation and amortization | (411,536 | ) | |
|
|||
242,928 | |||
OTHER ASSETS | 6,475 | ||
|
|||
TOTAL ASSETS | $ | 537,225 | |
|
|||
LIABILITIES AND STOCKHOLDERS EQUITY | |||
CURRENT LIABILITIES: | |||
Accounts payable | $ | 18,212 | |
Accrued expenses | 28,463 | ||
Current maturities of capital leases | 22,525 | ||
|
|||
Total current liabilities | 69,200 | ||
|
|||
COMMITMENTS (Note 3) | |||
SERIES A REDEEMABLE CONVERTIBLE PREFERRED STOCK, $.005 par | |||
value ($1,000,000 liquidation preference), 2,000,000 shares authorized, issued | |||
and outstanding as of December 31,2002 | 1,000,000 | ||
SERIES B REDEEMABLE CONVERTIBLE PREFERRED STOCK, $.005 par | |||
value ($5,048,604 liquidation preference), 6,775,333 shares authorized and | |||
5,048,604 shares issued and outstandingas of December 31, 2002 | 2,070,663 | ||
STOCKHOLDERS EQUITY: | |||
Common stock, $.005 par value, 17,000,000 shares authorized and 5,000,000 shares issued | |||
and outstanding as of December 31, 2002 | 25,000 | ||
Deferred compensation | (32 | ) | |
Additional paid-in capital | 404,023 | ||
Accumulated deficit | (3,031,629 | ) | |
|
|||
Total stockholders equity | (2,602,638 | ) | |
|
|||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY | $ | 537,225 | |
|
See notes to
financial statements.
F-53
SALUS THERAPEUTICS,
INC.
STATEMENT
OF OPERATIONS
YEAR ENDED
DECEMBER 31, 2002
REVENUES - GRANTS | $ | 386,510 | |
|
|||
OPERATING EXPENSES: | |||
Research and development | 854,376 | ||
General and administrative | 675,534 | ||
|
|||
Total operating expenses | 1,529,910 | ||
|
|||
LOSS FROM OPERATIONS | (1,143,400 | ) | |
|
|||
OTHER INCOME/(EXPENSE): | |||
Interest income | 4,938 | ||
Interest expense | (54,453 | ) | |
|
|||
Total other income/(expense) | (49,515 | ) | |
|
|||
NET LOSS | (1,192,915 | ) | |
Accretion of Series B redeemable convertible preferred stock to | |||
liquidation value | (292,654 | ) | |
|
|||
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (1,485,569 | ) |
|
See notes to
financial statements.
F-54
SALUS THERAPEUTICS,
INC.
STATEMENT
OF CASH FLOWS
YEAR ENDED
DECEMBER 31, 2002
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ | (1,192,915 | ) |
Adjustments to reconcile net loss to net cash used | |||
in operating activities: | |||
Depreciation and amortization | 109,042 | ||
Impairment of investment | 50,000 | ||
Amortization of deferred compensation expense | 3 | ||
(Increase) decrease in assets: | |||
Prepaid expenses | (15,085 | ) | |
Other assets | 6,473 | ||
Increase (decrease) in liabilities: | |||
Accounts payable | (52,585 | ) | |
Accrued expenses | 5,258 | ||
Interest payable | (38,577 | ) | |
|
|||
Net cash used in operating activities | (1,128,386 | ) | |
|
|||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Capital expenditures | (18,922 | ) | |
|
|||
Net cash used in investing activities | (18,922 | ) | |
|
|||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Repayments of term loan | (850,000 | ) | |
Repayments of subordinated notes | (75,000 | ) | |
Proceeds from sale of Series B redeemable convertible preferred | |||
stock, net of issuance costs | 2,469,532 | ||
Repayments under capital lease obligations | (127,290 | ) | |
|
|||
Net cash provided by financing activities | 1,417,242 | ||
|
|||
NET INCREASE IN CASH | 269,934 | ||
CASH, BEGINNING OF YEAR | 2,803 | ||
|
|||
CASH, END OF YEAR | $ | 272,737 | |
|
|||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||
Cash paid during the year for: | |||
Interest | $ | 61,113 | |
|
|||
Income taxes | $ | -- | |
|
|||
SUPPLEMENTAL DISCLOSURE OF NONCASH FLOW TRANSACTIONS: | |||
Record value of warrants issued with Series B redeemable convertible | |||
preferred stock | $ | 337,490 | |
|
|||
Record beneficial conversion feature associated with Series B redeemable convertible preferred stock |
$ | 392,260 | |
|
|||
Accrection of liquidation value on Series B redeemable convertible preferred stock |
$ | 330,882 | |
|
|||
See notes to
financial statements.
F-55
SALUS THERAPEUTICS,
INC.
STATEMENT
OF STOCKHOLDERS EQUITY
YEAR ENDED
DECEMBER 31, 2002
Common
Stock |
||||||||||||||||||
Shares | Amount | Paid-In
Capital |
Deferred
Compensation |
Retained
Earnings |
Total | |||||||||||||
|
|
|
|
|
|
|||||||||||||
BALANCE - January 1, 2002 | 5,000,000 | $ | 25,000 | $ | 5,119 | $ | - | $ | (1,838,714 | ) | $ | (1,808,595 | ) | |||||
|
- | |
- | 337,490 | |
- | |
|
337,490 | |||||||||
|
- | - | 392,261 | - | - | 392,261 | ||||||||||||
|
- | - | (330,882 | ) | - | - | (330,882) | |||||||||||
|
- | - | 35 | (35 | ) | - | - | |||||||||||
|
- | - | - | 3 | - | 3 | ||||||||||||
|
- | - | - | - | (1,192,915 | ) | |
(1,192,915 | ) | |||||||||
|
|
|
|
|
|
|||||||||||||
BALANCE - December 31, 2002 | 5,000,000 | $ | 25,000 | $ | 404,023 | $ | (32 | ) | $ | (3,031,629 | ) | $ | (2,602,638 | ) | ||||
|
|
|
|
|
|
See notes to
financial statements.
F-56
SALUS THERAPEUTICS,
INC.
NOTES TO
FINANCIAL STATEMENTS
YEARS ENDED
DECEMBER 31, 2002
1. | ORGANIZATION AND BUSINESS |
Salus Therapeutics, Inc. (the Company) was incorporated in Delaware on October 21, 1999. The Company is primarily involved in the research and development of technology that facilitates the rapid identification of optimal antisense targets on specified genes. The Company intends to research, develop and manufacture products by bioengineering and genetic transmutation.
2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Basis of Presentation The financial statements are presented
in accordance with accounting principles generally accepted in the United
States. The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make certain estimates
and assumptions that affect the amounts reported in the financial statements
and accompanying notes. Actual results could differ from those estimates.
Revenue Recognition Grant revenues are generated by grants from
the National Institutes of Health. Grant revenue is recorded by the Company
as it is earned under the terms of the agreement. As of December 31, 2002, the
Company is recognizing revenue under a grant that expired in July 2003.
Research and Development All expenditures for research
and development are charged to expense as incurred.
Property, Plant and Equipment Property and
equipment are recorded at cost. Depreciation and amortization are calculated
using the straight-line method over the estimated useful lives of the related
assets. The estimated useful life of equipment is 3 to 5 years, software
is 3 years, leasehold improvements are 5 years and furniture and fixtures
is 3 to 7 years.
Expenditures for routine maintenance and repairs are charged to operating
expenses as incurred. Major renewals or betterments that extend the useful
lives of existing assets are capitalized and depreciated over their estimated
useful lives. Upon retirement or disposition of property and equipment,
the cost and related accumulated depreciation are removed from the accounts,
and any resulting gain or loss is recorded as an operating expense in the
accompanying statements of operations.
Stock-Based Compensation The Company has one stock-based compensation
plan (Note 6). The Company accounts for stock-based compensation arrangements
in accordance with the provisions of Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to Employees, and complies with the
disclosure provisions of Statement of Financial Accounting Standards (SFAS)
No. 123, Accounting for Stock-Based Compensation, as amended by SFAS
No. 148, Accounting for Stock-Based Compensation Transition and Disclosure,
an amendment of FASB Statement No. 123. Under APB Opinion No. 25, compensation
expense is based on the difference, if any, on the date of grant, between the
fair value of the Companys stock and the exercise price of the option.
The Company accounts for stock options issued to non-employees in accordance
with the provisions of SFAS No. 123, and Emerging Issues Task Force Consensus
on Issue No. 96-18,
Accounting for Equity Instruments That Are Issued
to Other Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services. The Company is amortizing deferred stock compensation
using the graded vesting method, in accordance with the Financial Accounting
Standards Board Interpretation No. 28, over the vesting period of each
respective option, which is generally four years.
F-57
In December 2002, the Financial Accounting Standards Board (FASB) issued
SFAS No. 148 to provide alternative methods of transition for a voluntary
change to the fair value based method of accounting for stock-based employee
compensation. In addition, SFAS No. 148 amends the disclosure requirements
of SFAS No. 123 to require prominent disclosures in both annual and interim
financial statements about the method of accounting for stock-based employee
compensation and the effect of the method used on reported results. The
Company is required to implement SFAS No.148 in fiscal 2003 and certain
disclosure provisions for the year ended December 31, 2002. The Company
does not plan to adopt the fair value provisions of accounting for stock
based compensation; as such the Company does not believe that the adoption
of this statement will have a material impact on its financial position,
results of operations or cash flows.
The following table illustrates the effect on net loss if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation:
December
31, 2002
|
|||
---|---|---|---|
Net loss as reported | $ | (1,192,915 | ) |
Equity related employee compensation expense included in reported net | |||
loss, net of related tax effects | - | ||
Total stock-based employee compensation expense determined under fair | |||
values based method for all awards | (2,706 | ) | |
|
|||
Pro forma net loss | $ | (1,195,621 | ) |
|
The pro forma disclosures shown above were calculated for all options using the Black-Scholes option pricing model with the following assumptions:
December
31, 2002
|
||
---|---|---|
Expected dividend yield | - | |
Expected stock price volatility | - | |
Risk-free interest rate | 3.08 % | |
Weighted average expected life (in years) | 5 |
Recently Issued Accounting Standards In April 2002, the
FASB issued SFAS No. 145, Rescission of FASB Statements 4, 44 and 64,
Amendment of FASB Statement 13, and Technical Corrections. SFAS No.
145 rescinds the provisions of SFAS No. 4 that requires companies to classify
certain gains and losses from debt extinguishments as extraordinary items,
eliminates the provisions of SFAS No. 44 regarding transition to the Motor
Carrier Act of 1980 and amends the provisions of SFAS No. 13 to require
that certain lease modifications be treated as sale leaseback transactions.
The provisions of SFAS No. 145 related to classification of debt extinguishment
are effective for fiscal years beginning after May 15, 2002. Commencing
January 1, 2003, the Company will classify debt extinguishment costs within
income from operations. The provisions of SFAS No. 145 related to lease
modifications are effective for transactions occurring after May 15, 2002.
The Company does not expect the provisions of SFAS No. 145 related to lease
modifications to have a material impact on its financial position or results
of operations.
In June 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated
with Exit or Disposal Activities. SFAS No. 146 nullifies Emerging Issues
Task Force (EITF) No. 94-3, Liability Recognition for Certain Employee
Termination Benefits and Other Costs to Exit an Activity (including Certain
Costs Incurred in a Restructuring). The principal difference between
SFAS No. 146 and EITF No. 94-3 relates to its requirements for recognition
of a liability for a cost associated with an exit or disposal activity.
SFAS No. 146 requires that a liability for a cost associated with an exit
or disposal activity be recognized when the liability is incurred. Under
EITF No. 94-3, a liability for an exit cost was recognized at the date
of an entitys commitment to an exit plan. SFAS No. 146 is effective for
exit and disposal activities that are
F-58
initiated after
December 31, 2002. The adoption of this statement did not have a material
impact on the Companys financial position or results of operations.
In April 2003, the FASB issued SFAS No. 149, Amendment of Statement
133 on Derivative Instruments and Hedging Activities. SFAS No. 149
amends and clarifies financial accounting and reporting for derivative
instruments, including certain derivative instruments embedded in other
contracts (collectively referred to as derivatives) and for hedging activities
under SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities. In particular, SFAS No. 149 (1) clarifies under what circumstances
a contract with an initial net investment meets the characteristic of a
derivative discussed in paragraph 6(b) of SFAS No. 133, (2) clarifies when
a derivative contains a financing component, (3) amends the definition
of an underlying to conform it to language used in FIN 45, Guarantors
Accounting and Disclosure Requirements for Guarantees, Including Indirect
Guarantees of Indebtedness of Others, and (4) amends certain other
existing pronouncements. SFAS No. 149 is to be applied prospectively to
contracts entered into or modified after June 30, 2003, with certain exceptions,
and for hedging relationships designated after June 30, 2003. The Company
believes that adopting this statement will not have a material impact on
the Companys results of operations, financial position or cash flows.
In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of Liabilities, Equity, or Both. This limited scope statement prescribes changes to the classification of certain financial instruments including preferred securities issued in the form of shares that are mandatorily redeemable; that embody an unconditional obligation requiring the issuer to redeem them by transferring its assets at a specified or determinable date (or dates) or upon an event that is certain to occur. This Statement is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003. The Company has not completed the process of evaluating the impact that will result from the adoption of this statement and is therefore unable to disclose the impact the adoption will have on its financial position and results of operations.
In November 2002, FASB Interpretation (FIN) 45, Guarantors Accounting
and Disclosure Requirements for Guarantees, Including Indirect Guarantees
of Indebtedness of Others, was approved by the FASB. FIN 45 clarifies
that a guarantor is required to recognize, at the inception of a guarantee,
a liability for the fair value of the obligation undertaken in issuing
the guarantee. The initial recognition and initial measurement provisions
of this interpretation are applicable on a prospective basis to guarantees
issued or modified after December 31, 2002. The interpretation also requires
enhanced and additional disclosures of guarantees in financial statements
ending after December 15, 2002. In the normal course of business, the Company
does not issue guarantees, accordingly this interpretation has no effect
on the financial statements.
In January 2003, the FASB issued Interpretation No. (FIN) 46, Consolidation
of Variable Interest Entities. The Company has no arrangements that
would be subject to this interpretation.
Income Taxes The Company recognizes deferred income tax
assets and liabilities for the future tax consequences of events that have
been recognized in the financial statements or income tax returns. Deferred
tax assets and liabilities are determined based upon the difference between
the financial statements and income tax basis of assets and liabilities
using the enacted tax rates expected to apply when the differences are
expected to be settled of realized.
Impairment of Long-Lived Assets The Company evaluates the recoverability
of long-lived assets in accordance with Statement of Financial Accounting
Standards No. 144,
Accounting for the Impairment or Disposal of Long-Lived
Assets. SFAS No. 144 requires recognition of impairment of long-lived
assets in the event the net book value of such assets exceeds the future
undiscounted cash flows attributable to such assets. Management has determined
that no such impairment exists. As of December 31, 2002, the Company does
not consider any of its long-lived assets to be impaired.
Fair Value of Financial Instruments The carrying amounts reported
in the accompanying financial statements for cash and accounts payable
approximate fair values because of the immediate or short-
F-59
term maturities of these financial instruments. The carrying amount of the Companys redeemable preferred stock approximates fair value.
3. | COMMITMENTS |
Capital Leases |
The Company leases certain laboratory and office equipment under capital
leases. As of December 31, 2002, the cost of assets held under capital
lease was $351,579 and related accumulated depreciation was $226,938.
The future minimum obligations under such leases in effect at December 31, 2002 consist of the following:
Year Ending December 31, | Capital Leases | ||
|
|
||
2003 | $ 22,818 | ||
|
|||
22,818 | |||
Less amount representing interest | 293 | ||
|
|||
Present value of net minimum capital lease payments | $ 22,525 | ||
|
|||
Operating Leases |
The Company is committed under non-cancelable operating leases involving office
facilities and office equipment. Rent expense for operating leases was $114,677
for the year ended December 31, 2002, which is the net of $8,105 in sublease
income received under a cancelable agreement with a related party (Note 9).
The future minimum obligations under such leases in effect at December 31, 2002 consist of the following:
Year Ending December 31, | Operating Leases | ||
|
|
||
2003 | 84,985 | ||
2004 | 201,707 | ||
2005 | 207,758 | ||
2006 | 213,990 | ||
2007 | 220,413 | ||
Thereafter | 226,452 | ||
|
|||
$1,155,305 | |||
|
|||
Technology License Agreement |
In October 1999, the Company entered into a license agreement with the University
of Utah Research Foundation (the Foundation). The agreement provided the Company
with an exclusive worldwide license to utilize certain methods for generating
robozyme libraries for use in locating sites accessible to antisense agents.
The license granted under this agreement provides for exclusive rights through
October 2009. If the Company meets certain requirements stated in the agreement,
the license will be extended to a term ending upon the expiration of the related
patent rights.
As consideration for the license, the Company issued 300,000 shares of
its common stock to the Foundation and paid a nonrefundable fee of $5,000
during 1999. Additionally, in the event of a subsequent round of financing,
the Foundation has the right to invest in additional shares on a pro-rata
basis, at the same price as granted to other investors holding common or
preferred stock.
F-60
In June 2002, the University of Utah Research Foundation acknowledged that
the Company performed its obligation required in the agreement noted above.
As such, the original agreement was terminated and an amended and restated
license agreement was issued. As part of the new agreement, the Company
paid a non-refundable license issue fee of $5,000 and $13,676 in related
closing costs during 2002.
Under the license agreement, the Company is required among other things to: (a) pay an earned royalty of two percent of net sales (as defined in the agreement); (b) pay a license maintenance fee of $10,000 in 2003, $15,000 in 2004 and $20,000 in 2005 and beyond until the end of the term of the last to expire patent rights, (c) pay various one time payments based upon the achievement of certain milestones (as defined in the agreement).
4. | REDEEMABLE CONVERTIBLE PREFERRED STOCK |
Series A Redeemable Convertible Preferred Stock
The Company has authorized 8,775,333 shares of preferred stock with $0.005
par value, 2,000,000 of which have been designated as Series A redeemable,
convertible preferred stock (Series A). On November 17, 1999, the Company
sold 2,000,000 shares of Series A for $1,000,000. The holder of Series
A has the right to a number of votes equal to the number of shares of common
stock upon conversion of the Series A. In addition, the holder of the Series
A is entitled to elect one of the members of the board of directors of
the Company. Each share of Series A is convertible into one share of common
stock at the option of the shareholder, subject to adjustment for anti-dilution
provisions.
The Series A stockholder is required to convert the shares into common
stock, at the then applicable conversion rate, upon the earlier to occur
of (1) the closing of a firmly underwritten public offering of shares of
common stock of the Company at a per share public offering price equal
to $2.50 (as adjusted for stock splits, dividends, and recapitalizations)
and the total gross offering proceeds to the Company in excess of $25 million
or (2) the affirmative consent of a majority of the holders of the then
outstanding shares of Series A. In the event of voluntary or involuntary
liquidation or dissolution, the Series A stockholder is entitled to receive
the original purchase price plus any declared and unpaid dividends, prior
to any distribution of any of the net assets of the Company to the holders
of common stock.
The Series A stockholder is entitled to a noncumulative, 8 percent dividend
rate payable when and if declared by the Board of Directors. As of December
31, 2002, no dividends have been declared.
Shares of Series A are redeemable in three annual installments beginning
on November 17, 2004 at the election of holders of a majority of the shares.
The redemption price is equal to the price paid for the Series A plus any
declared and unpaid dividends.
The Series A stockholder has a right of participation to purchase a share of any offering of new securities of the Company equal to the proportion which the number of shares of the Series A bears to the Companys fully-diluted capitalization. Such right terminates immediately prior to closing of a qualified public offering.
Series B Redeemable Convertible Preferred Stock |
In June 2002, the Board of Directors approved the authorization of a series
of Preferred Stock designated as the Series B Preferred Stock, consisting
of up to 6,775,333 shares with such rights, preferences, privileges and
restrictions as set forth therein.
On June 26, 2002 the Company issued 5,048,604 shares of Series B redeemable
convertible preferred stock (Series B) to investors for $2,469,532, net of
issuance costs of $54,770. The Series B is being accreted to its liquidation
value over the period to its earliest redemption date. Accretion was $330,882
for the year ended December 31, 2002.
F-61
The holder of Series B has the right to a number of votes equal to the
number of shares of common stock upon conversion of the Series B. In addition,
the holder of the Series B is entitled to elect one of the members of the
board of directors of the Company. Each share of Series B is convertible
into one share of common stock at the option of the shareholder, subject
to adjustment for anti-dilution provisions.
The Series B stockholder is required to convert the shares into common
stock, at the then applicable conversion rate, upon the earlier to occur
of (1) the closing of a firmly underwritten public offering of shares of
common stock of the Company at a per share public offering price equal
to $2.50 (as adjusted for stock splits, dividends, and recapitalizations)
and the total gross offering proceeds to the Company in excess of $25 million
or (2) the affirmative consent of a majority of the holders of the then
outstanding shares of Series B. In the event of voluntary or involuntary
liquidation or dissolution, the Series B stockholder is entitled to receive
two times the original purchase price plus any declared and unpaid dividends,
prior to any distribution of any of the net assets of the Company to the
holders of common stock. Also, after the preferred preferential liquidation
proceeds, the Series A stockholder participates in liquidation proceeds
with the common stock.
The Series B stockholder is entitled to a noncumulative, 8 percent dividend
rate payable when and if declared by the Board of Directors. As of December
31, 2002, no dividends have been declared.
Shares of Series B are redeemable in three annual installments beginning
on June 26, 2007 at the election of holders of a majority of the shares.
The redemption price is equal to the price paid for the Series B plus any
declared and unpaid dividends.
The Series B stockholder has a right of participation to purchase a share of any offering of new securities of the Company equal to the proportion which the number of shares of the Series B bears to the Companys fully-diluted capitalization. Such right terminates immediately prior to closing of a qualified public offering.
5. | STOCKHOLDERS EQUITY |
Common Stock |
In October 1999, the Company issued 4,700,000 shares of common stock to
founders of the Company in exchange for $28,312. The Company has the right
of first refusal in connection with any sale or transfer of shares of common
stock by existing shareholders. Under the founders agreements, the Company
has the option to repurchase all or a portion of the common shares at the
original purchase price paid. These repurchase rights expire in various
amounts over 4 years or earlier upon the occurrence of certain events.
In October 1999, the Company issued 300,000 share of common stock to the
Foundation in connection with a license agreement (Note 3) and recorded
research and development expense of $1,807.
In June 2002, the Board of Directors approved an amendment to increase the authorized common stock to 17,000,000 shares from 4,700,000 shares.
Warrants |
On June 26, 2002, the Company issued 976,728 warrants to purchase shares of the Series B redeemable preferred stock of the Company to a stockholder. These warrants have an exercise price of $0.50 and expire no later than June 26, 2009. The Company has attributed a portion of the proceeds from the Series B offering to the fair value of the warrants. The warrants were valued at $337,490. The fair value of the warrants have been recorded as an initial discount to the carrying value of the related Series B.
6. | STOCK-BASED COMPENSATION |
F-62
1999 Equity Incentive Plan |
The Companys 1999 Equity Incentive Plan provides for the sale of stock
and the grant of stock options to employees, directors, consultants and
advisors of the Company. Options may be designated as incentive options
or non-statutory stock options; however, incentive stock options may be
granted only to employees of the Company. Options under the Plan have a
term of up to 10 years and must be granted at not less than the fair market
value or 85% of fair market value for non-statutory options on the date
of grant. Common stock sold and options granted pursuant to the Plan generally
vest over a period of 4 years.
The Board of Directors of the Company authorized 1,450,000 shares of common stock for issuance. The number of shares, exercise price and term for each grant are determined by the Board of Directors. A summary of activity under the plan follows:
Shares
|
Weighted
Average
Exercise Price |
||||
---|---|---|---|---|---|
Outstanding at January 1, 2002 | 1,025,000 | $ 0.05 | |||
Granted | 215,000 | 0.05 | |||
|
|||||
Outstanding at December 31, 2002 | 1,240,000 | $ 0.05 | |||
|
Of the total options outstanding, 5,000 were granted to a consultant and
expire 10 years from the grant date. One-fourth of these options vested
on the grant date and the remaining vest 1/48 per month over the next three
years. In accordance with SFAS No. 123, the Company recorded deferred compensation
of $35 related to the non-employee option grant, of which $32 was unamortized
at December 31, 2002. The remaining 1,235,000 options were granted to employees
and directors at fair market value and expire 10 years from the date of
the grant.
In 2002, a total of 215,000 options were granted pursuant to the 1999 Equity
Incentive Plan at fair market value with a weighted average grant date
fair value of $0.05 per share. No options were granted below fair market
value.
Of the outstanding options, the total exercisable shares were 538,646 as of December 31, 2002. Their respective weighted average exercise prices were $0.05. The weighted average fair value of options granted during the year ended December 31, 2002 was $0.01.
7. | EMPLOYEE BENEFIT PLAN |
In October 2002, the Company initiated sponsorship of the Salus Therapeutics, Inc. 401(K) Profit Sharing Plan, a defined contribution plan under Section 401(K) of the Internal Revenue Code. The Company did not make any matching contributions for the year ended December 31, 2002.
8. | INCOME TAXES |
As of December 31, 2002, the Company has generated net operating loss carryforwards
(NOLs) for federal and state income tax reporting purposes of approximately
$2,936,000 and had net deferred tax assets of approximately $1,162,000. There
can be no assurance that these NOLs will be available to offset future taxable
income, if any. An NOL generated in a particular year will expire for federal
tax purposes if not utilized within 20 years. Additionally, the Internal Revenue
Code contains other provisions which could reduce or limit the availability
and utilization of these NOLs. For example, limitations are imposed on the utilization
of NOLs if certain ownership changes have taken place or will take place. A
valuation allowance is provided when it is more than likely than not that all
or some portion of the deferred income tax assets will not be realized. Due
to the uncertainty with respect to the ultimate realization of the NOLs, at
December 31, 2002, the Company established a valuation allowance for all deferred
income tax assets.
F-63
9. | RELATED-PARTY TRANSACTIONS |
During the year ended December 31, 2002, two entities owned by a stockholder
of the Company rented office space from the Company under month-to-month
cancelable agreements. The Company recorded rental income of $8,105 for
the year ended December 31, 2002, which was recorded as a reduction of
rent expense.
In addition, one of these entities utilized some of the Companys laboratory
equipment under a month-to-month cancelable agreement. In January 2002, an agreement
was reached in which the Company would refund the related entity a one-time
$40,000 payment, related to overpayments of rental income. The Company recorded
the $40,000 payment as an operating expense. During the remainder of 2002, this
amount was offset by $12,247 in rental income related to this equipment.
During 2002, the Company also utilized equipment owned by a related party. Total rent expense related to that equipment for the year ended December 31, 2002 was $18,097.
10. | SUBSEQUENT EVENTS |
On August 21, 2003, the Company was acquired by Genta Incorporated, a biopharmaceutical
company with a diversified product portfolio that is focused on delivering innovative
products for the treatment of patients with cancer, located in Berkeley Heights,
New Jersey. Under the terms of the merger agreement, Genta issued approximately
1 million shares of its common stock with a fair value of approximately $13
million to Salus stockholders in exchange for all of the outstanding shares
of Salus common stock, including those issued pursuant to the conversion of
Salus preferred stock. Approximately thirty-five percent of the initial
payment is held in escrow and will be released on the first anniversary of the
acquisition, assuming no events of default occur as described in the merger
agreement. Contingent upon the achievement of certain preclinical and clinical
milestones, an additional $17 million may be paid in stock or cash at Gentas
option.
In June 2003, the Company entered into a new lease agreement for office
space totaling 11,178 square feet of space, at a rental cost of approximately
$199,000 per year. The lease shall be for a period of 5 full lease years
ending November 30, 2008. The Company will also be responsible for the
tenants pro rata share of operating expenses.
In May 2003, a Series B stockholder loaned $125,000 to the Company in the
form of a short-term subordinated convertible promissory note. The note
bears interest at 8.0 percent and is due on May 6, 2004. On August 21,
2003, this note was converted into Series B redeemable convertible preferred
stock and ultimately exchanged for Genta common stock as a result of the
acquisition described above.
In April 2003 and June 2003, a Series B stockholder loaned $250,000 to
the Company in the form of a short-term subordinated convertible promissory
note. The note bears interest at 8.0 percent and is due on July 2, 2003
and September 10, 2003, respectively. On August 21, 2003, this note was
converted into Series B redeemable convertible preferred stock and ultimately
exchanged for Genta common stock as a result of the acquisition described
above.
In April 2003, the Company issued options to purchase 57,500 shares of
common stock to various employees at an exercise price of $0.05 per share
which vest over a four-year period.
F-64
No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus. You must not rely on any unauthorized information or representations. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date.
TABLE
OF CONTENTS |
|
Page
|
|
Risk Factors | 1 |
Special Note Regarding Forward-Looking Statements | 11 |
Use of Proceeds | 12 |
Price Range of Common Stock | 13 |
Dividend Policy | 13 |
Capitalization | 14 |
Managements Discussion and Analysis of Financial Condition and Results of Operations | 17 |
Business | 26 |
Management | 41 |
Relationships and Related Transactions | 48 |
Principal and Selling Stockholders | 49 |
Description of Capital Stock | 52 |
Common Stock Eligible for Future Sale | 58 |
Plan of Distribution | 59 |
Legal Matters | 60 |
Experts | 60 |
Where You Can Find More Information | 60 |
Index to Consolidated Financial Statements | F-1 |
671,412 Shares
Genta Incorporated
Common Stock
PART II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item 13.
Other
Expenses of Issuance and Distribution.
Amount
To Be Paid |
|||
---|---|---|---|
Registration fee | $ | 581 | |
Legal fees and expenses | 100,000 | ||
Accounting fees and expenses | 50,000 | ||
Miscellaneous | 10,000 | ||
|
|||
Total | $ | 160,581 | |
|
Each of the amounts set forth above other than the Registration fee is
an estimate.
Item 14.
Indemnification of Directors and Officers.
Section 102(b)(7) of the Delaware General Corporation Law permits a corporation
to provide in its certificate of incorporation that a director of the corporation
shall not be personally liable to the corporation or its stockholders for
monetary damages for breach of fiduciary duty as a director, except for
liability (i) for any breach of the directors duty of loyalty to the corporation
or its stockholders, (ii) for acts or omissions not in good faith or which
involve intentional misconduct or a knowing violation of law, (iii) for
unlawful payments of dividends or unlawful stock repurchases, redemptions
or other distributions, or (iv) for any transaction from which the director
derived an improper personal benefit.
Section 145 of the Delaware General Corporation Law provides that a corporation may indemnify any person, including a director or officer, who is, or is threatened to be made, a party to any threatened, pending or completed legal action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of fact that such person is or was a director, officer, employee or agent of such corporation, or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or other enterprise against expenses (including attorneys fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the corporations best interests and, with respect to any criminal actions or proceedings, had no reasonable cause to believe that his conduct was unlawful. A Delaware corporation may provide similar indemnification in an action or suit by or in the right of the corporation, except that no indemnification is permitted if the director or officer is adjudged to be liable to the corporation unless and to the extent the Court of Chancery or the court in which such action was brought determines that such person is reasonably entitled to indemnify. Where a director or officer is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him or her against the expenses which such director or officer actually and reasonably incurred.
Article VIII of Gentas restated certificate of incorporation, as amended,
provides indemnification of directors and officers of Genta to the fullest
extent permitted by the Delaware General Corporation Law.
Genta maintains liability insurance for each director and officer for certain losses arising from claims or charges made against them while acting in their capacities as directors or officers of the Registrant.
Item 15.
Recent
Sales of Unregistered Securities.
Since October 1, 2000, the Registrant has sold the following securities
without registration under the Securities Act of 1933:
II-1
In November 2000, the Company sold 4.285 million shares of common stock
through a private placement and received proceeds of approximately $26.8
million, net of placement costs of $1.633 million. The placement agents,
one a related party stockholder, received cash commissions equal to 7.0%
of the gross sales price. The sale was exempt from registration under the
Securities Act pursuant to Section 4(2) and Regulation D.
In December 2000, the Company recorded $1.268 million as the fair value
for its commitment to issue 162,338 shares of common stock to a major university
as consideration for an amendment to a license agreement initially executed
on August 1, 1991. The sale was exempt from registration under the Securities
Act pursuant to Section 4(2) and Regulation D.
In November 2001, the Company sold 2.5 million shares of common stock through
a private placement and received proceeds of approximately $32.2 million,
net of placement agent commissions of $0.420 million and related expenses.
The sale was exempt from registration under the Securities Act pursuant
to Section 4(2) and Regulation D.
In May 2002, the Company sold 6.665 million shares of common stock to Aventis in connection with a collaborative agreement and received proceeds of $71.0 million, net of investment banking fees of $0.899 million and related expenses. The sale was exempt from registration under the Securities Act pursuant to Section 4(2) and Regulation D.
Item 16.
Exhibits
and Financial Statement Schedules.
(a) The following exhibits are filed as part of this Registration Statement:
Exhibit
Number |
Description |
3.1.a | Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).1 to the Companys Annual Report on Form 10-K for the year ended December 31, 1995, Commission File No. 0-19635) |
3.1.b | Certificate of Designations of Series D Convertible Preferred Stock of the Company (incorporated by reference to Exhibit 3(i) to the Companys Current Report on Form 8-K filed on February 28, 1997, Commission File No. 0-19635) |
3.1.c | Certificate of Amendment of Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).3 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
3.1.d | Amended Certificate of Designations of Series D Convertible Preferred Stock of the Company (incorporated by reference to Exhibit 3(i).4 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
3.1.e | Certificate of Increase of Series D Convertible Preferred Stock of the Company (incorporated by reference to Exhibit 3(i).5 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
3.1.f | Certificate of Amendment of Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).4 to the Companys Annual Report on Form 10-K for the year ended December 31, 1998, Commission File No. 0-19635) |
3.1.g | Certificate of Amendment of Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).3 to the Companys Annual Report on Form 10-K for the year ended December 31, 1998, Commission File No. 0-19635) |
3.1.h | Certificate of Amendment of Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).8 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
3.1.i | Certificate of Amendment of Restated Certificate of Incorporation of the Company |
3.1.j | Certificate of Amendment of Restated Certificate of Incorporation of the Company |
3.2 | Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3(ii).1 to the Companys Annual Report on Form 10-K for the year ended December 31, 1998, Commission File No. 0-19635) |
II-2
Exhibit
Number |
Description |
4.1 | Specimen Common Stock Certificate |
5 | Opinion of Davis Polk & Wardwell |
10.1 | Amended and Restated 1991 Stock Plan of Genta Incorporated (incorporated by reference to Exhibit 10.1 to the Companys Registration Statement on Form S-8, Reg. No. 33-85888) |
10.2 | Non-Employee Directors 1998 Stock Option Plan, as amended and restated (incorporated by reference to Exhibit 4.2 to the Companys Registration Statement on Form S-8, Reg. No. 333-101022) |
10.3 | 1998 Stock Incentive Plan, as amended and restated, effective June 25, 2003 |
10.4 | Form of Indemnification Agreement entered into between the Company and its directors and officers (incorporated by reference to Exhibit 10.7 to the Companys Registration Statement on Form S-1, Reg. No. 33-43642) |
10.5* | Development, License and Supply Agreement dated February 2, 1989 between the Company and Gen-Probe Incorporated (incorporated by reference to Exhibit 10.10 to the Companys Registration Statement on Form S-1, Reg. No. 33-43642) |
10.6 | Contract for Regional Aid for Innovation, effective July 1, 1993, between LAgence Nationale de Valorisation de la Recherche, Genta Pharmaceuticals Europe S.A. and the Company (incorporated by reference to Exhibit 10.98 to the Companys Annual Report on Form 10-K for the year ended December 31, 1996, Commission File No. 0-19635) |
10.7 | Asset Purchase Agreement, dated as of March 19, 1999, among JBL Acquisition Corp., JBL Scientific Incorporated and the Company (incorporated by reference to Exhibit 10.2 to the Companys Quarterly Report filed on Form 10-Q for the quarter ended March 31, 1999, Commission File No. 0-19635) |
10.8 | Warrant Agreement, dated as of December 23, 1999, among the Company, ChaseMellon Shareholder Services, L.L.C., as warrant agent, and Paramount Capital, Inc. (incorporated by reference to Exhibit 10.67 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
10.9 | Employment Letter Agreement, dated as of October 28, 1999, from the Company to Raymond P. Warrell, Jr., M.D. (incorporated by reference to Exhibit 10.70 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
10.10 | Stock Option Agreement, dated as of October 28, 1999, between the Company and Raymond P. Warrell, Jr., M.D. (incorporated by reference to Exhibit 10.71 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
10.11 | Letter Agreement, dated March 4, 1999, from SkyePharma Plc to the Company (incorporated by reference to Exhibit 10.72 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
10.12 | Subscription Agreement executed in connection with the November 26, 2001 sale of common stock to Franklin Small-Mid Cap Growth Fund, Franklin Biotechnology Discovery Fund, and SF Capital Partners Ltd., and the November 30, 2001 sale of common stock to SF Capital Partners Ltd. (incorporated by reference to Exhibit 10.73 to the Companys Annual Report on Form 10-K for the year ended December 31, 2001, Commission File No. 0-19635) |
10.13 | Employment Letter Agreement, dated as of March 27, 2001, from the Company to Loretta M. Itri, M.D. (incorporated by reference to Exhibit 10.74 to the Companys Annual Report on Form 10-K for the year ended December 31, 2001, Commission File No. 0-19635) |
10.14 | Agreement of Lease dated June 28, 2000 between The Connell Company and the Company (incorporated by reference to Exhibit 10.76 to the Companys Annual Report on Form 10-K for the year ended December 31, 2001, Commission File No. 0-19635) |
10.14A | Amendment of Lease, dated June 19, 2002 between The Connell Company and the Company (incorporated by reference to Exhibit 10.10 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
II-3
Exhibit
Number |
Description |
10.15 | Agreement of Sublease dated August 13, 2001 between Expanets, Inc. and the Company (incorporated by reference to Exhibit 10.77 to the Companys Annual Report on Form 10-K for the year ended December 31, 2001, Commission File No. 0-19635) |
10.16* | U.S. Commercialization Agreement dated April 26, 2002, by and between Genta Incorporated and Aventis Pharmaceuticals Inc. (incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.16A* | Amendment No. 1 dated March 14, 2003 to the U.S. Commercialization Agreement between Genta Incorporated and Aventis Pharmaceuticals Inc. (incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2003, Commission File No. 0-19635) |
10.17* | Ex-U.S. Commercialization Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.2 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.18* | Global Supply Agreement, dated April 26, 2002, by and among Genta Incorporated, Aventis Pharmaceuticals Inc. and Garliston Limited (incorporated by reference to Exhibit 10.3 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.19* | Securities Purchase Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.4 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.20 | Standstill and Voting Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.5 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.21 | Registration Rights Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.6 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.22 | Convertible Note Purchase Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.7 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.23* | 5.63% Convertible Promissory Note, due April 26, 2009 (incorporated by reference to Exhibit 10.8 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.24* | Subordination Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.9 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.25* | Manufacture and Supply Agreement, dated December 20, 2002, between Genta Incorporated and Avecia Biotechnology Inc. (incorporated by reference to Exhibit 10.88 to the Companys Annual Report on Form 10-K for the year ended December 31, 2002, Commission File No. 0-19635) |
10.26 | Employment Agreement, dated as of December 1, 2002, between the Company and Raymond P. Warrell, Jr., M.D. (incorporated by reference to Exhibit 10.89 to the Companys Annual Report on Form 10-K/A for the year ended December 31, 2001, Commission File No. 0-19635) |
10.27 | Employment Agreement, dated as of August 5, 2003, between the Company and Loretta M. Itri, M.D. (incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2003, Commission File No. 0-19635) |
II-4
Exhibit
Number |
Description |
10.28** | License Agreement dated August 1, 1991, between Genta Incorporated and the Trustees of the University of Pennsylvania (incorporated by reference to Exhibit 99.1 to the Companys Current Report on Form 8-K filed on October 28, 2003, Commission File No. 0-19635) |
10.28A** | Amendment to License Agreement, dated December 19, 2000, between Genta Incorporated and the Trustees of the University of Pennsylvania (incorporated by reference to Exhibit 99.2 to the Companys Current Report on Form 8-K filed on October 28, 2003, Commission File No. 0-19635) |
10.28AA** | Second Amendment to License Agreement, dated October 22, 2003, between Genta Incorporated and the Trustees of the University of Pennsylvania (incorporated by reference to Exhibit 99.3 to the Companys Current Report on Form 8-K filed on October 28, 2003, Commission File No. 0-19635) |
10.29 | Settlement Agreement and Release, dated October 22, 2003, between Genta Incorporated and the Trustees of the University of Pennsylvania (incorporated by reference to Exhibit 99.4 to the Companys Current Report on Form 8-K filed on October 28, 2003, Commission File No. 0-19635) |
21 | Subsidiaries of the Registrant |
23.1 | Consent of Deloitte & Touche LLP |
23.2 | Consent of Davis Polk & Wardwell (included in Exhibit 5) |
24.1 | Power of Attorney (included on signature page) |
* | The Company has been granted confidential treatment of certain portions of this exhibit. |
** | The Company has requested confidential treatment of certain portions of this exhibit. |
(b) The following financial statement schedule is filed as part of this
Registration Statement:
None. |
Item 17. Undertakings
The undersigned hereby undertakes:
(a) (1) To file, during any period in which offers or sales are being made
of securities registered hereby, a post-effective amendment to this registration
statement:
(i) to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933; |
(ii) to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Securities and Exchange Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the Calculation of Registration Fee table in the effective registration statement; |
(iii) to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered herein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(b) Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers and controlling persons
of the registrant pursuant to the provisions referenced in Item 14 of this
Registration Statement, or otherwise, the registrant has been advised that
in the opinion of the Securities and Exchange Commission such indemnification
is against public policy as expressed in the Act and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities
II-5
(other than
the payment by the registrant of expenses incurred or paid by a director,
officer, or controlling person of the registrant in the successful defense
of any action, suit or proceeding) is asserted by such director, officer
or controlling person in connection with the securities being registered
hereunder, the registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question of whether such indemnification by
it is against public policy as expressed in the Act and will be governed
by the final adjudication of such issue.
(c) The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective. |
(2) For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new Registration Statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
II-6
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Berkeley Heights, State of New Jersey, on the 4th day of November, 2003.
GENTA INCORPORATED |
By: | /s/ WILLIAM P. KEANE
|
Name: Title: |
William P. Keane Vice President, Chief Financial Officer, and Corporate Secretary |
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears
below constitutes and appoints Raymond P. Warrell, Jr., M.D., William P.
Keane and Stefan Grant, and each of them, his or her true and lawful attorneys-in-fact
and agents, with full power of substitution and resubstitution, for him
or her and in his or her name, place and stead, in any and all capacities,
to sign any and all amendments (including post-effective amendments) to
this registration statement and any and all additional registration statements
pursuant to Rule 462(b) of the Securities Act of 1933, as amended, and
to file the same, with all exhibits thereto, and all other documents in
connection therewith, with the Securities and Exchange Commission, granting
unto each said attorney-in-fact and agents full power and authority to
do and perform each and every act in person, hereby ratifying and confirming
all that said attorneys-in-fact and agents or either of them or their or
his or her substitute or substitutes may lawfully do or cause to be done
by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.
Signature | Title | Date |
/s/ RAYMOND P. WARRELL, JR., M.D.
Raymond P. Warrell, Jr., M.D. |
Chairman
of the Board of Directors
and Chief Executive Officer (Principal Executive Officer) |
November 4, 2003 |
/s/ WILLIAM P. KEANE
William P. Keane |
Vice President, Chief Financial Officer
and Corporate Secretary (Principal Accounting Officer) |
November 4, 2003 |
/s/ JEROME E. GROOPMAN, M.D.
Jerome E. Groopman, M.D. |
Director | November 4, 2003 |
/s/ BETSY MCCAUGHEY
Betsy McCaughey, Ph.D. |
Director | November 4, 2003 |
/s/ DANIEL D. VON HOFF, M.D.
Daniel D. Von Hoff, M.D. |
Director | November 4, 2003 |
/s/ HARLAN J. WAKOFF
Harlan J. Wakoff |
Director | November 4, 2003 |
/s/ DOUGLAS G. WATSON
Douglas G. Watson |
Director | November 4, 2003 |
/s/ MICHAEL S. WEISS
Michael S. Weiss |
Director | November 4, 2003 |
/s/ PATRICK J. ZENNER
Patrick J. Zenner |
Director | November 4, 2003 |
EXHIBIT INDEX
Exhibit
Number |
Description |
3.1.a | Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).1 to the Companys Annual Report on Form 10-K for the year ended December 31, 1995, Commission File No. 0-19635) |
3.1.b | Certificate of Designations of Series D Convertible Preferred Stock of the Company (incorporated by reference to Exhibit 3(i) to the Companys Current Report on Form 8-K filed on February 28, 1997, Commission File No. 0-19635) |
3.1.c | Certificate of Amendment of Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).3 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
3.1.d | Amended Certificate of Designations of Series D Convertible Preferred Stock of the Company (incorporated by reference to Exhibit 3(i).4 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
3.1.e | Certificate of Increase of Series D Convertible Preferred Stock of the Company (incorporated by reference to Exhibit 3(i).5 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
3.1.f | Certificate of Amendment of Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).4 to the Companys Annual Report on Form 10-K for the year ended December 31, 1998, Commission File No. 0-19635) |
3.1.g | Certificate of Amendment of Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).3 to the Companys Annual Report on Form 10-K for the year ended December 31, 1998, Commission File No. 0-19635) |
3.1.h | Certificate of Amendment of Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3(i).8 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
3.1.i | Certificate of Amendment of Restated Certificate of Incorporation of the Company |
3.1.j | Certificate of Amendment of Restated Certificate of Incorporation of the Company |
3.2 | Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3(ii).1 to the Companys Annual Report on Form 10-K for the year ended December 31, 1998, Commission File No. 0-19635) |
4.1 | Specimen Common Stock Certificate |
5 | Opinion of Davis Polk & Wardwell |
10.1 | Amended and Restated 1991 Stock Plan of Genta Incorporated (incorporated by reference to Exhibit 10.1 to the Companys Registration Statement on Form S-8, Reg. No. 33-85888) |
Exhibit
Number |
Description |
10.2 | Non-Employee Directors 1998 Stock Option Plan, as amended and restated (incorporated by reference to Exhibit 4.2 to the Companys Registration Statement on Form S-8, Reg. No. 333-101022) |
10.3 | 1998 Stock Incentive Plan, as amended and restated, effective June 25, 2003 |
10.4 | Form of Indemnification Agreement entered into between the Company and its directors and officers (incorporated by reference to Exhibit 10.7 to the Companys Registration Statement on Form S-1, Reg. No. 33-43642) |
10.5* | Development, License and Supply Agreement dated February 2, 1989 between the Company and Gen-Probe Incorporated (incorporated by reference to Exhibit 10.10 to the Companys Registration Statement on Form S-1, Reg. No. 33-43642) |
10.6 | Contract for Regional Aid for Innovation, effective July 1, 1993, between LAgence Nationale de Valorisation de la Recherche, Genta Pharmaceuticals Europe S.A. and the Company (incorporated by reference to Exhibit 10.98 to the Companys Annual Report on Form 10-K for the year ended December 31, 1996, Commission File No. 0-19635) |
10.7 | Asset Purchase Agreement, dated as of March 19, 1999, among JBL Acquisition Corp., JBL Scientific Incorporated and the Company (incorporated by reference to Exhibit 10.2 to the Companys Quarterly Report filed on Form 10-Q for the quarter ended March 31, 1999, Commission File No. 0-19635) |
10.8 | Warrant Agreement, dated as of December 23, 1999, among the Company, ChaseMellon Shareholder Services, L.L.C., as warrant agent, and Paramount Capital, Inc. (incorporated by reference to Exhibit 10.67 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
10.9 | Employment Letter Agreement, dated as of October 28, 1999, from the Company to Raymond P. Warrell, Jr., M.D. (incorporated by reference to Exhibit 10.70 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
10.10 | Stock Option Agreement, dated as of October 28, 1999, between the Company and Raymond P. Warrell, Jr., M.D. (incorporated by reference to Exhibit 10.71 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
10.11 | Letter Agreement, dated March 4, 1999, from SkyePharma Plc to the Company (incorporated by reference to Exhibit 10.72 to the Companys Annual Report on Form 10-K for the year ended December 31, 1999, Commission File No. 0-19635) |
10.12 | Subscription Agreement executed in connection with the November 26, 2001 sale of common stock to Franklin Small-Mid Cap Growth Fund, Franklin Biotechnology Discovery Fund, and SF Capital Partners Ltd., and the November 30, 2001 sale of common stock to SF Capital Partners Ltd. (incorporated by reference to Exhibit 10.73 to the Companys Annual Report on Form 10-K for the year ended December 31, 2001, Commission File No. 0-19635) |
Exhibit
Number |
Description |
10.13 | Employment Letter Agreement, dated as of March 27, 2001, from the Company to Loretta M. Itri, M.D. (incorporated by reference to Exhibit 10.74 to the Companys Annual Report on Form 10-K for the year ended December 31, 2001, Commission File No. 0-19635) |
10.14 | Agreement of Lease dated June 28, 2000 between The Connell Company and the Company (incorporated by reference to Exhibit 10.76 to the Companys Annual Report on Form 10-K for the year ended December 31, 2001, Commission File No. 0-19635) |
10.14A | Amendment of Lease, dated June 19, 2002 between The Connell Company and the Company (incorporated by reference to Exhibit 10.10 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.15 | Agreement of Sublease dated August 13, 2001 between Expanets, Inc. and the Company (incorporated by reference to Exhibit 10.77 to the Companys Annual Report on Form 10-K for the year ended December 31, 2001, Commission File No. 0-19635) |
10.16* | U.S. Commercialization Agreement dated April 26, 2002, by and between Genta Incorporated and Aventis Pharmaceuticals Inc. (incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.16A* | Amendment No. 1 dated March 14, 2003 to the U.S. Commercialization Agreement between Genta Incorporated and Aventis Pharmaceuticals Inc. (incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2003, Commission File No. 0-19635) |
10.17* | Ex-U.S. Commercialization Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.2 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.18* | Global Supply Agreement, dated April 26, 2002, by and among Genta Incorporated, Aventis Pharmaceuticals Inc. and Garliston Limited (incorporated by reference to Exhibit 10.3 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.19* | Securities Purchase Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.4 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.20 | Standstill and Voting Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.5 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.21 | Registration Rights Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.6 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
Exhibit
Number |
Description |
10.22 | Convertible Note Purchase Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.7 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.23* | 5.63% Convertible Promissory Note, due April 26, 2009 (incorporated by reference to Exhibit 10.8 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.24* | Subordination Agreement, dated April 26, 2002, by and between Genta Incorporated and Garliston Limited (incorporated by reference to Exhibit 10.9 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, Commission File No. 0-19635) |
10.25* | Manufacture and Supply Agreement, dated December 20, 2002, between Genta Incorporated and Avecia Biotechnology Inc. (incorporated by reference to Exhibit 10.88 to the Companys Annual Report on Form 10-K for the year ended December 31, 2002, Commission File No. 0-19635) |
10.26 | Employment Agreement, dated as of December 1, 2002, between the Company and Raymond P. Warrell, Jr., M.D. (incorporated by reference to Exhibit 10.89 to the Companys Annual Report on Form 10-K/A for the year ended December 31, 2001, Commission File No. 0-19635) |
10.27 | Employment Agreement, dated as of August 5, 2003, between the Company and Loretta M. Itri, M.D. (incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2003, Commission File No. 0-19635) |
10.28** | License Agreement dated August 1, 1991, between Genta Incorporated and the Trustees of the University of Pennsylvania (incorporated by reference to Exhibit 99.1 to the Companys Current Report on Form 8-K filed October 28, 2003, Commission File No. 0-19635) |
10.28A** | Amendment to License Agreement, dated December 19, 2000, between Genta Incorporated and the Trustees of the University of Pennsylvania (incorporated by reference to Exhibit 99.2 to the Companys Current Report on Form 8-K filed on October 28, 2003, Commission File No. 0-19635) |
10.28AA** | Second Amendment to License Agreement, dated October 22, 2003, between Genta Incorporated and the Trustees of the University of Pennsylvania (incorporated by reference to Exhibit 99.3 to the Companys Current Report on Form 8-K filed on October 28, 2003, Commission File No. 0-19635) |
10.29 | Settlement Agreement and Release, dated October 22, 2003, between Genta Incorporated and the Trustees of the University of Pennsylvania (incorporated by reference to Exhibit 99.4 to the Companys Current Report on Form 8-K filed on October 28, 2003, Commission File No. 0-19635) |
21 | Subsidiaries of the Registrant |
23.1 | Consent of Deloitte & Touche LLP |
23.2 | Consent of Davis Polk & Wardwell (included in Exhibit 5) |
24.1 | Power of Attorney (included on signature page) |
* | The Company has been granted confidential treatment of certain portions of this exhibit. |
** | The Company has requested confidential treatment of certain portions of this exhibit. |