PFE - 3/29/2015 - 10Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
X QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 29, 2015
OR
TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______ to _______
COMMISSION FILE NUMBER 1-3619
----
PFIZER INC.
(Exact name of registrant as specified in its charter)
|
| |
DELAWARE (State of Incorporation) | 13-5315170 (I.R.S. Employer Identification No.) |
235 East 42nd Street, New York, New York 10017
(Address of principal executive offices) (zip code)
(212) 733-2323
(Registrant’s telephone number)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (check one):
Large Accelerated filer X Accelerated filer ___ Non-accelerated filer ___ Smaller reporting company ___
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
At May 4, 2015, 6,157,669,933 shares of the issuer’s voting common stock were outstanding.
Table of Contents |
| |
| Page |
| |
| |
| |
| |
Condensed Consolidated Statements of Income for the three months ended March 29, 2015 and March 30, 2014 | |
| |
Condensed Consolidated Statements of Comprehensive Income for the three months ended March 29, 2015 and March 30, 2014 | |
| |
Condensed Consolidated Balance Sheets as of March 29, 2015 and December 31, 2014 | |
| |
Condensed Consolidated Statements of Cash Flows for the three months ended March 29, 2015 and March 30, 2014 | |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
|
| | | | | | | | |
| | Three Months Ended |
(MILLIONS, EXCEPT PER COMMON SHARE DATA) | | March 29, 2015 |
| | March 30, 2014 |
|
Revenues | | $ | 10,864 |
| | $ | 11,353 |
|
Costs and expenses: | | | | |
Cost of sales(a) | | 1,838 |
| | 2,045 |
|
Selling, informational and administrative expenses(a) | | 3,104 |
| | 3,040 |
|
Research and development expenses(a) | | 1,885 |
| | 1,623 |
|
Amortization of intangible assets | | 940 |
| | 1,117 |
|
Restructuring charges and certain acquisition-related costs | | 60 |
| | 58 |
|
Other (income)/deductions––net | | (46 | ) | | 623 |
|
Income from continuing operations before provision for taxes on income | | 3,082 |
| | 2,847 |
|
Provision for taxes on income | | 706 |
| | 582 |
|
Income from continuing operations | | 2,376 |
| | 2,265 |
|
Discontinued operations––net of tax | | 5 |
| | 73 |
|
Net income before allocation to noncontrolling interests | | 2,381 |
| | 2,338 |
|
Less: Net income attributable to noncontrolling interests | | 6 |
| | 9 |
|
Net income attributable to Pfizer Inc. | | $ | 2,376 |
| | $ | 2,329 |
|
| | | | |
Earnings per common share––basic: | | |
| | |
|
Income from continuing operations attributable to Pfizer Inc. common shareholders | | $ | 0.38 |
| | $ | 0.35 |
|
Discontinued operations––net of tax | | — |
| | 0.01 |
|
Net income attributable to Pfizer Inc. common shareholders | | $ | 0.38 |
| | $ | 0.36 |
|
| | | | |
Earnings per common share––diluted: | | |
| | |
|
Income from continuing operations attributable to Pfizer Inc. common shareholders | | $ | 0.38 |
| | $ | 0.35 |
|
Discontinued operations––net of tax | | — |
| | 0.01 |
|
Net income attributable to Pfizer Inc. common shareholders | | $ | 0.38 |
| | $ | 0.36 |
|
| | | | |
Weighted-average shares––basic | | 6,203 |
| | 6,389 |
|
Weighted-average shares––diluted | | 6,292 |
| | 6,476 |
|
Cash dividends paid per common share | | $ | 0.28 |
| | $ | 0.26 |
|
| |
(a) | Excludes amortization of intangible assets, except as disclosed in Note 9A. Identifiable Intangible Assets and Goodwill:Identifiable Intangible Assets. |
Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(UNAUDITED)
|
| | | | | | | | |
| | Three Months Ended |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | March 30, 2014 |
|
Net income before allocation to noncontrolling interests | | $ | 2,381 |
| | $ | 2,338 |
|
| | | | |
Foreign currency translation adjustments | | $ | (1,308 | ) | | $ | (75 | ) |
Reclassification adjustments(a) | | — |
| | (62 | ) |
| | (1,308 | ) | | (137 | ) |
Unrealized holding losses on derivative financial instruments, net | | (315 | ) | | (58 | ) |
Reclassification adjustments for realized losses(b) | | 234 |
| | 12 |
|
| | (82 | ) | | (46 | ) |
Unrealized holding gains/(losses) on available-for-sale securities, net | | (328 | ) | | 108 |
|
Reclassification adjustments for realized (gains)/losses(b) | | 247 |
| | (99 | ) |
| | (81 | ) | | 9 |
|
Benefit plans: actuarial gains, net | | 32 |
| | 6 |
|
Reclassification adjustments related to amortization(c) | | 136 |
| | 49 |
|
Reclassification adjustments related to settlements, net(c) | | 40 |
| | 21 |
|
Other | | 158 |
| | (17 | ) |
| | 365 |
| | 59 |
|
Benefit plans: prior service costs and other, net | | (1 | ) | | — |
|
Reclassification adjustments related to amortization(c) | | (35 | ) | | (18 | ) |
Reclassification adjustments related to curtailments, net(c) | | (10 | ) | | (4 | ) |
Other | | — |
| | (1 | ) |
| | (46 | ) | | (23 | ) |
Other comprehensive loss, before tax | | (1,152 | ) | | (138 | ) |
Tax provision/(benefit) on other comprehensive loss(d) | | 105 |
| | (17 | ) |
Other comprehensive loss before allocation to noncontrolling interests | | $ | (1,257 | ) | | $ | (121 | ) |
| | | | |
Comprehensive income before allocation to noncontrolling interests | | $ | 1,124 |
| | $ | 2,217 |
|
Less: Comprehensive income/(loss) attributable to noncontrolling interests | | (10 | ) | | 7 |
|
Comprehensive income attributable to Pfizer Inc. | | $ | 1,134 |
| | $ | 2,210 |
|
| |
(a) | Reclassified into Discontinued operations—net of tax in the condensed consolidated statements of income. |
| |
(b) | Reclassified into Other (income)/deductions—net in the condensed consolidated statements of income. |
| |
(c) | Generally reclassified, as part of net periodic pension cost, into Cost of sales, Selling, informational and administrative expenses, and/or Research and development expenses, as appropriate, in the condensed consolidated statements of income. For additional information, see Note 10. Pension and Postretirement Benefit Plans. |
| |
(d) | See Note 5C. Tax Matters: Tax Provision/(Benefit) on Other Comprehensive Loss. |
Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
| | | | | | | | |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | December 31, 2014 |
|
| | (Unaudited) | | |
Assets | | | | |
Cash and cash equivalents | | $ | 3,563 |
| | $ | 3,343 |
|
Short-term investments | | 24,145 |
| | 32,779 |
|
Trade accounts receivable, less allowance for doubtful accounts: 2015—$444; 2014—$412 | | 8,920 |
| | 8,669 |
|
Inventories | | 5,786 |
| | 5,663 |
|
Current deferred tax assets and other current tax assets | | 4,214 |
| | 4,498 |
|
Other current assets | | 2,815 |
| | 2,750 |
|
Total current assets | | 49,443 |
| | 57,702 |
|
Long-term investments | | 18,289 |
| | 17,518 |
|
Property, plant and equipment, less accumulated depreciation | | 11,527 |
| | 11,762 |
|
Identifiable intangible assets, less accumulated amortization | | 34,334 |
| | 35,166 |
|
Goodwill | | 41,854 |
| | 42,069 |
|
Noncurrent deferred tax assets and other noncurrent tax assets | | 1,477 |
| | 1,544 |
|
Other noncurrent assets | | 3,716 |
| | 3,513 |
|
Total assets | | $ | 160,640 |
| | $ | 169,274 |
|
| | | | |
Liabilities and Equity | | |
| | |
|
Short-term borrowings, including current portion of long-term debt | | $ | 6,555 |
| | $ | 5,141 |
|
Trade accounts payable | | 2,724 |
| | 3,210 |
|
Dividends payable | | — |
| | 1,711 |
|
Income taxes payable | | 944 |
| | 531 |
|
Accrued compensation and related items | | 1,679 |
| | 1,841 |
|
Other current liabilities | | 8,320 |
| | 9,197 |
|
Total current liabilities | | 20,222 |
| | 21,631 |
|
| | | | |
Long-term debt | | 29,370 |
| | 31,541 |
|
Pension benefit obligations, net | | 6,571 |
| | 7,885 |
|
Postretirement benefit obligations, net | | 2,480 |
| | 2,379 |
|
Noncurrent deferred tax liabilities | | 24,474 |
| | 24,981 |
|
Other taxes payable | | 4,293 |
| | 4,353 |
|
Other noncurrent liabilities | | 5,644 |
| | 4,883 |
|
Total liabilities | | 93,053 |
| | 97,652 |
|
| | | | |
| | | | |
Preferred stock | | 28 |
| | 29 |
|
Common stock | | 458 |
| | 455 |
|
Additional paid-in capital | | 80,004 |
| | 78,977 |
|
Treasury stock | | (79,100 | ) | | (73,021 | ) |
Retained earnings | | 74,471 |
| | 72,176 |
|
Accumulated other comprehensive loss | | (8,557 | ) | | (7,316 | ) |
Total Pfizer Inc. shareholders’ equity | | 67,304 |
| | 71,301 |
|
Equity attributable to noncontrolling interests | | 283 |
| | 321 |
|
Total equity | | 67,587 |
| | 71,622 |
|
Total liabilities and equity | | $ | 160,640 |
| | $ | 169,274 |
|
Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED) |
| | | | | | | | |
| | Three Months Ended |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | March 30, 2014 |
|
Operating Activities | | | | |
Net income before allocation to noncontrolling interests | | $ | 2,381 |
| | $ | 2,338 |
|
Adjustments to reconcile net income before allocation to noncontrolling interests to net cash provided by operating activities: | | |
| | |
|
Depreciation and amortization | | 1,260 |
| | 1,456 |
|
Asset write-offs and impairments | | 11 |
| | 137 |
|
Deferred taxes from continuing operations | | (41 | ) | | 345 |
|
Share-based compensation expense | | 162 |
| | 143 |
|
Benefit plan contributions in excess of expense | | (874 | ) | | (99 | ) |
Other adjustments, net | | (336 | ) | | (294 | ) |
Other changes in assets and liabilities, net of acquisitions and divestitures | | (1,879 | ) | | (1,091 | ) |
Net cash provided by operating activities | | 685 |
| | 2,935 |
|
| | | | |
Investing Activities | | |
| | |
|
Purchases of property, plant and equipment | | (239 | ) | | (292 | ) |
Purchases of short-term investments | | (7,546 | ) | | (8,721 | ) |
Proceeds from redemptions/sales of short-term investments | | 10,702 |
| | 7,569 |
|
Net proceeds from redemptions/sales of short-term investments with original maturities of 90 days or less | | 5,243 |
| | 1,500 |
|
Purchases of long-term investments | | (3,150 | ) | | (1,808 | ) |
Proceeds from redemptions/sales of long-term investments | | 1,937 |
| | 1,454 |
|
Acquisitions of businesses, net of cash acquired | | (678 | ) | | — |
|
Acquisitions of intangible assets | | (7 | ) | | (6 | ) |
Other investing activities, net | | 330 |
| | 206 |
|
Net cash provided by/(used in) investing activities | | 6,592 |
| | (98 | ) |
| | | | |
Financing Activities | | |
| | |
|
Proceeds from short-term borrowings | | 1,998 |
| | — |
|
Principal payments on short-term borrowings | | — |
| | (3 | ) |
Net proceeds from short-term borrowings with original maturities of 90 days or less | | 863 |
| | 1,031 |
|
Principal payments on long-term debt | | (3,002 | ) | | (752 | ) |
Purchases of common stock | | (6,000 | ) | | (1,197 | ) |
Cash dividends paid | | (1,758 | ) | | (1,662 | ) |
Proceeds from exercise of stock options | | 794 |
| | 425 |
|
Other financing activities, net | | 122 |
| | 25 |
|
Net cash used in financing activities | | (6,982 | ) | | (2,133 | ) |
Effect of exchange-rate changes on cash and cash equivalents | | (74 | ) | | (25 | ) |
Net increase in cash and cash equivalents | | 220 |
| | 679 |
|
Cash and cash equivalents, beginning | | 3,343 |
| | 2,183 |
|
Cash and cash equivalents, end | | $ | 3,563 |
| | $ | 2,862 |
|
| | |
| | |
|
Supplemental Cash Flow Information | | | | |
Cash paid during the period for: | | |
| | |
|
Income taxes | | $ | 372 |
| | $ | 536 |
|
Interest | | 332 |
| | 361 |
|
Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 1. Basis of Presentation and Significant Accounting Policies
A. Basis of Presentation
We prepared the condensed consolidated financial statements following the requirements of the U.S. Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by accounting principles generally accepted in the United States of America (U.S. GAAP) can be condensed or omitted.
Balance sheet amounts and operating results for subsidiaries operating outside the U.S. are as of and for the three months ended February 22, 2015 and February 23, 2014.
In the condensed consolidated balance sheet as of December 31, 2014, we performed certain reclassifications to conform to current period presentation, none of which were material to our financial statements.
On February 5, 2015, we announced that we have entered into a definitive merger agreement under which we agreed to acquire Hospira, Inc. (Hospira), the world’s leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, for $90 per share in cash, for a total enterprise value of approximately $17 billion. We expect to finance the transaction through a combination of existing cash and new debt, with approximately two-thirds of the value financed from cash and one-third from debt. The transaction is subject to customary closing conditions, including regulatory approvals in several jurisdictions and the approval of Hospira's shareholders, and is expected to close in the second half of 2015.
Revenues, expenses, assets and liabilities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year.
We are responsible for the unaudited financial statements included in this Quarterly Report on Form 10-Q. The financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of our condensed consolidated balance sheets and condensed consolidated statements of income.
The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2014 Annual Report on Form 10-K.
Certain amounts in the condensed consolidated financial statements and associated notes may not add due to rounding. All percentages have been calculated using unrounded amounts.
B. Adoption of New Accounting Standard
We adopted a new accounting and disclosure standard as of January 1, 2015 that limits the presentation of discontinued operations to business circumstances when the disposal of the business operation represents a strategic shift that has had or will have a major effect on our operations and financial results. This new standard is applied prospectively to all disposals (or classifications as held for sale) of components of an entity that occur within annual periods beginning on or after December
15, 2014, and interim periods within those years. We did not have any disposals within the scope of this new standard and, therefore, there were no impacts to our condensed consolidated financial statements.
C. Fair Value
Our fair value methodologies depend on the following types of inputs:
| |
• | Quoted prices for identical assets or liabilities in active markets (Level 1 inputs). |
| |
• | Quoted prices for similar assets or liabilities in active markets or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means (Level 2 inputs). |
| |
• | Unobservable inputs that reflect estimates and assumptions (Level 3 inputs). |
A single estimate of fair value can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 2. Acquisition, Collaborative Arrangements and Equity-Method Investment
A. Acquisition
Marketed Vaccines Business of Baxter International Inc. (Baxter)
On December 1, 2014 (which falls in the first fiscal quarter of 2015 for our international operations), we completed the acquisition of Baxter's portfolio of marketed vaccines for a final purchase price of $648 million. The portfolio that was acquired consists of NeisVac-C and FSME-IMMUN/TicoVac. NeisVac-C is a vaccine that helps protect against meningitis caused by group C meningococcal meningitis and FSME-IMMUN/TicoVac is a vaccine that helps protect against tick-borne encephalitis. In connection with this acquisition, we recorded $376 million in Identifiable intangible assets, primarily consisting of $371 million in Developed technology rights. We also recorded $196 million of Inventories and $11 million in Goodwill. The final allocation of the consideration transferred to the assets acquired and the liabilities assumed has not yet been completed.
B. Collaborative Arrangements
Collaboration with Eli Lilly & Company (Lilly)
In October 2013, we entered into a collaboration agreement with Lilly to jointly develop and globally commercialize Pfizer's tanezumab, which provides that Pfizer and Lilly will equally share product-development expenses as well as potential revenues and certain product-related costs. On March 23, 2015, Pfizer and Lilly announced that the companies are preparing to resume the Phase 3 clinical program for tanezumab. As a result, we received a $200 million upfront payment from Lilly in accordance with the collaboration agreement between Pfizer and Lilly, which was recorded as deferred revenue in our condensed consolidated balance sheet as of March 29, 2015 and is being recognized into Other (income)/deductions––net over a multi-year period beginning in the second quarter of 2015. This announcement followed a decision by the U.S. Food and Drug Administration (FDA) to lift the partial clinical hold on the tanezumab development program after a review of nonclinical data characterizing the sympathetic nervous system response to tanezumab. Under the collaboration agreement with Lilly, we are eligible to receive certain payments from Lilly upon the achievement of specified regulatory and commercial milestones, including the aforementioned upfront payment of $200 million, which was contingent upon the parties continuing in the collaboration after receipt of the FDA’s response to the submission of the nonclinical data.
Collaboration with OPKO Health, Inc. (OPKO)
On December 13, 2014, we entered into a collaborative agreement with OPKO to develop and commercialize OPKO’s long-acting human growth hormone (hGH-CTP) for the treatment of growth hormone deficiency (GHD) in adults and children, as well as for the treatment of growth failure in children born small for gestational age (SGA) who fail to show catch-up growth by two years of age. hGH-CTP has the potential to reduce the required dosing frequency of human growth hormone to a single weekly injection from the current standard of one injection per day. The transaction closed on January 28, 2015, upon termination of the waiting period under the Hart-Scott Rodino Act. In February 2015, we made an upfront payment of $295 million to OPKO, which was recorded in Research and development expenses, and OPKO is eligible to receive up to an additional $275 million upon the achievement of certain regulatory milestones. We have received the exclusive license to commercialize hGH-CTP worldwide. Subject to regulatory approval, OPKO is eligible to receive royalty payments associated with the commercialization of hGH-CTP for Adult GHD. Upon the launch of hGH-CTP for Pediatric GHD, the royalties will transition to tiered gross profit sharing for both hGH-CTP and our product, Genotropin. OPKO will lead the clinical activities and will be responsible for funding the development programs for the key indications, which includes Adult and Pediatric GHD and Pediatric SGA. We will be responsible for all development costs for additional indications, as well as all postmarketing studies and the commercialization activities for all indications, and lead the manufacturing activities covered by the global development plan.
C. Equity-Method Investment
Investment in ViiV Healthcare Limited (ViiV)
Our minority ownership interest in ViiV, a company formed in 2009 by Pfizer and GlaxoSmithKline plc (GSK) to focus solely on research, development and commercialization of human immunodeficiency virus (HIV) medicines, was impacted by the January 21, 2014 European Commission approval of Tivicay (dolutegravir), a product for the treatment of HIV-1 infection, developed by ViiV. This approval triggered a reduction in our equity interest in ViiV from 12.6% to 11.7%, effective April 1, 2014. As a result, in the first quarter of 2014, we recognized a loss of approximately $36 million in Other (income)/deductions––net.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
We incur significant costs in connection with acquiring, integrating and restructuring businesses and in connection with our global cost-reduction/productivity initiatives. For example:
| |
• | In connection with acquisition activity, we typically incur costs associated with executing the transactions, integrating the acquired operations (which may include expenditures for consulting and the integration of systems and processes), and restructuring the combined company (which may include charges related to employees, assets and activities that will not continue in the combined company); and |
| |
• | In connection with our cost-reduction/productivity initiatives, we typically incur costs and charges associated with site closings and other facility rationalization actions, workforce reductions and the expansion of shared services, including the development of global systems. |
All of our businesses and functions may be impacted by these actions, including sales and marketing, manufacturing and research and development (R&D), as well as groups such as information technology, shared services and corporate operations.
In early 2014, we announced that we would be incurring costs in 2014-2016 related to new programs: our new global commercial structure reorganization and additional cost-reduction/productivity initiatives.
We have the following initiatives underway:
| |
• | Manufacturing plant network rationalization and optimization, where execution timelines are necessarily long. Our plant network strategy is expected to result in the exit of six sites over the next several years. In connection with these activities, during 2014-2016, we expect to incur costs of approximately $300 million associated with prior acquisition activity and costs of approximately $1.5 billion associated with new non-acquisition-related cost-reduction initiatives. Through March 29, 2015, we incurred approximately $205 million and $293 million, respectively, associated with these initiatives. |
| |
• | New global commercial structure reorganization, which primarily includes the streamlining of certain functions, the realignment of regional locations and colleagues to support the businesses, as well as implementing the necessary system changes to support future reporting requirements. In connection with this reorganization, during 2014-2016, we expect to incur costs of approximately $300 million. Through March 29, 2015, we incurred approximately $179 million associated with this reorganization. |
| |
• | Other new cost-reduction/productivity initiatives, primarily related to commercial property rationalization and consolidation. In connection with these cost-reduction activities, during 2014-2016, we expect to incur costs of approximately $850 million. Through March 29, 2015, we incurred approximately $231 million associated with these initiatives. |
The costs expected to be incurred during 2014-2016, of approximately $2.9 billion in total, include restructuring charges, integration costs, implementation costs and additional depreciation––asset restructuring. Of this amount, we expect that about a quarter of the charges will be non-cash.
Current-Period Key Activities
In the first quarter of 2015, we incurred approximately $121 million in cost-reduction and acquisition-related costs (excluding transaction costs) in connection with the aforementioned programs, primarily associated with our manufacturing and sales operations.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
|
| | | | | | | | |
The following table provides the components of costs associated with acquisitions and cost-reduction/productivity initiatives: |
| | Three Months Ended |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | March 30, 2014 |
|
Restructuring charges(a): | | |
| | |
|
Employee terminations | | $ | 31 |
| | $ | 30 |
|
Asset impairments | | 6 |
| | 6 |
|
Exit costs | | 6 |
| | 4 |
|
Total restructuring charges | | 42 |
| | 40 |
|
Transaction costs(b) | | 5 |
| | — |
|
Integration costs(c) | | 13 |
| | 18 |
|
Restructuring charges and certain acquisition-related costs | | 60 |
| | 58 |
|
Additional depreciation––asset restructuring recorded in our condensed consolidated statements of income as follows(d): | | |
| | |
|
Cost of sales | | 17 |
| | 74 |
|
Research and development expenses | | 1 |
| | — |
|
Total additional depreciation––asset restructuring | | 18 |
| | 74 |
|
Implementation costs recorded in our condensed consolidated statements of income as follows(e): | | |
| | |
|
Cost of sales | | 13 |
| | 6 |
|
Selling, informational and administrative expenses | | 26 |
| | 15 |
|
Research and development expenses | | 8 |
| | 11 |
|
Total implementation costs | | 48 |
| | 32 |
|
Total costs associated with acquisitions and cost-reduction/productivity initiatives | | $ | 127 |
| | $ | 164 |
|
| |
(a) | In the three months ended March 29, 2015, Employee terminations represent the expected reduction of the workforce by approximately 200 employees, mainly in manufacturing and sales. |
The restructuring charges for the three months ended March 29, 2015 are associated with the following:
| |
• | the Global Innovative Pharmaceutical segment (GIP) ($12 million); the Global Vaccines, Oncology and Consumer Healthcare segment (VOC) ($13 million); the Global Established Pharmaceutical segment (GEP) ($10 million); Worldwide Research and Development and Medical ($12 million); manufacturing operations ($22 million income); and Corporate ($18 million). |
The restructuring charges for the three months ended March 30, 2014 are associated with the following:
| |
• | the Global Innovative Pharmaceutical segment (GIP) ($2 million); the Global Established Pharmaceutical segment (GEP) ($7 million); Worldwide Research and Development and Medical ($1 million); manufacturing operations ($26 million); and Corporate ($4 million). |
| |
(b) | Transaction costs represent external costs directly related to acquired businesses and primarily include expenditures for banking, legal, accounting and other similar services. |
| |
(c) | Integration costs represent external, incremental costs directly related to integrating acquired businesses, and primarily include expenditures for consulting and the integration of systems and processes. |
| |
(d) | Additional depreciation––asset restructuring represents the impact of changes in the estimated useful lives of assets involved in restructuring actions. |
| |
(e) | Implementation costs represent external, incremental costs directly related to implementing our non-acquisition-related cost-reduction/productivity initiatives. |
|
| | | | | | | | | | | | | | | | |
The following table provides the components of and changes in our restructuring accruals: |
(MILLIONS OF DOLLARS) | | Employee Termination Costs |
| | Asset Impairment Charges |
| | Exit Costs |
| | Accrual |
|
Balance, December 31, 2014(a) | | $ | 1,114 |
| | $ | — |
| | $ | 52 |
| | $ | 1,166 |
|
Provision | | 31 |
| | 6 |
| | 6 |
| | 42 |
|
Utilization and other(b) | | (127 | ) | | (6 | ) | | (30 | ) | | (162 | ) |
Balance, March 29, 2015(c) | | $ | 1,019 |
| | $ | — |
| | $ | 28 |
| | $ | 1,046 |
|
| |
(a) | Included in Other current liabilities ($735 million) and Other noncurrent liabilities ($431 million). |
| |
(b) | Includes adjustments for foreign currency translation. |
| |
(c) | Included in Other current liabilities ($648 million) and Other noncurrent liabilities ($398 million). |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 4. Other (Income)/Deductions—Net
|
| | | | | | | | |
The following table provides components of Other (income)/deductions––net: |
| | Three Months Ended |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | March 30, 2014 |
|
Interest income | | $ | (93 | ) | | $ | (92 | ) |
Interest expense(a) | | 309 |
| | 321 |
|
Net interest expense | | 216 |
| | 229 |
|
Royalty-related income(b) | | (222 | ) | | (248 | ) |
Certain legal matters, net(c) | | — |
| | 694 |
|
Net gains on asset disposals(d) | | (175 | ) | | (181 | ) |
Certain asset impairments(e) | | — |
| | 115 |
|
Business and legal entity alignment costs(f) | | 101 |
| | 29 |
|
Other, net | | 34 |
| | (15 | ) |
Other (income)/deductions––net | | $ | (46 | ) | | $ | 623 |
|
| |
(a) | Interest expense decreased in the first quarter of 2015, primarily due to lower interest rates on new fixed rate debt added in the second quarter of 2014 and the benefit of the effective conversion of some fixed-rate liabilities to floating-rate liabilities. |
| |
(b) | Royalty-related income decreased in the first quarter of 2015, primarily due to a decrease in royalties earned on Amgen Inc.'s sales of Enbrel in the U.S. and Canada due to a decrease in the royalty rate per the terms of the collaboration agreement. |
| |
(c) | In the first quarter of 2014, primarily includes approximately $620 million for Neurontin-related matters (including off-label promotion actions and antitrust actions) and approximately $50 million for an Effexor-related matter. |
| |
(d) | In the first quarter of 2015, primarily includes gains on sales/out-licensing of product and compound rights (approximately $45 million) and gains on sales of investments in equity securities (approximately $120 million). In the first quarter of 2014, primarily includes gains on sales/out-licensing of product and compound rights (approximately $70 million) and gains on sales of investments in equity securities (approximately $95 million). |
| |
(e) | In the first quarter of 2014, includes an intangible asset impairment charge of $114 million, virtually all of which relates to an in-process research and development (IPR&D) compound for the treatment of skin fibrosis. The intangible asset impairment charge for the first quarter of 2014 is associated with Worldwide Research and Development and reflects, among other things, the impact of changes to the development program. |
| |
(f) | In the first quarter of 2015 and 2014, represents expenses for planning and implementing changes to our infrastructure to align our operations and reporting for our business segments established in 2014. |
Note 5. Tax Matters
A. Taxes on Income from Continuing Operations
Our effective tax rate for continuing operations was 22.9% for the first quarter of 2015, compared to 20.4% for the first quarter of 2014.
The higher effective tax rate for the first quarter of 2015 in comparison with the same period in 2014 was primarily due to:
| |
• | a decline in favorable benefits associated with the resolution of certain tax positions pertaining to prior years, primarily with various foreign tax authorities, and the expiration of certain statutes of limitations, |
partially offset by:
| |
• | the favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business. |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
B. Tax Contingencies
We are subject to income tax in many jurisdictions, and a certain degree of estimation is required in recording the assets and liabilities related to income taxes. All of our tax positions are subject to audit by the local taxing authorities in each tax jurisdiction. These tax audits can involve complex issues, interpretations and judgments and the resolution of matters may span multiple years, particularly if subject to negotiation or litigation. Our assessments are based on estimates and assumptions that have been deemed reasonable by management, but our estimates of unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes, and variation from such estimates could materially affect our financial statements in the period of settlement or when the statutes of limitations expire, as we treat these events as discrete items in the period of resolution.
The U.S. is one of our major tax jurisdictions, and we are regularly audited by the IRS:
| |
• | With respect to Pfizer Inc., tax years 2009-2013 are currently under audit. Tax years 2014 and 2015 are open, but not under audit. All other tax years are closed. |
In addition to the open audit years in the U.S., we have open audit years in other major tax jurisdictions, such as Canada (2004-2015), Japan (2013-2015), Europe (2007-2015, primarily reflecting Ireland, the United Kingdom, France, Italy, Spain and Germany), Latin America (1998-2015, primarily reflecting Brazil) and Puerto Rico (2009-2015).
C. Tax Provision/(Benefit) on Other Comprehensive Loss
|
| | | | | | | | |
The following table provides the components of the Tax provision/(benefit) on Other comprehensive loss: |
| | Three Months Ended |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | March 30, 2014 |
|
| | | | |
Foreign currency translation adjustments(a) | | $ | 85 |
| | $ | (7 | ) |
Unrealized holding losses on derivative financial instruments, net | | (224 | ) | | (17 | ) |
Reclassification adjustments for realized losses | | 183 |
| | (1 | ) |
| | (41 | ) | | (18 | ) |
Unrealized holding gains/(losses) on available-for-sale securities, net | | (31 | ) | | 27 |
|
Reclassification adjustments for realized (gains)/losses | | (1 | ) | | (29 | ) |
| | (32 | ) | | (2 | ) |
Benefit plans: actuarial gains, net | | 12 |
| | 1 |
|
Reclassification adjustments related to amortization | | 46 |
| | 16 |
|
Reclassification adjustments related to settlements, net | | 15 |
| | 8 |
|
Other | | 37 |
| | (12 | ) |
| | 109 |
| | 13 |
|
Reclassification adjustments related to amortization | | (13 | ) | | (7 | ) |
Reclassification adjustments related to curtailments, net | | (4 | ) | | (1 | ) |
Other | | — |
| | 5 |
|
| | (17 | ) | | (3 | ) |
Tax provision/(benefit) on other comprehensive loss | | $ | 105 |
| | $ | (17 | ) |
| |
(a) | Taxes are not provided for foreign currency translation adjustments relating to investments in international subsidiaries that will be held indefinitely. |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 6. Accumulated Other Comprehensive Loss, Excluding Noncontrolling Interests
|
| | | | | | | | | | | | | | | | | | | | | | | | |
The following table provides the changes, net of tax, in Accumulated other comprehensive loss: |
| | Net Unrealized Gains/(Losses) | | Benefit Plans | | |
(MILLIONS OF DOLLARS) | | Foreign Currency Translation Adjustments |
| | Derivative Financial Instruments |
| | Available-For-Sale Securities |
| | Actuarial Gains/(Losses) |
| | Prior Service (Costs)/Credits and Other |
| | Accumulated Other Comprehensive Loss |
|
Balance, December 31, 2014 | | $ | (2,689 | ) | | $ | 517 |
| | $ | (222 | ) | | $ | (5,654 | ) | | $ | 733 |
| | $ | (7,316 | ) |
Other comprehensive income/(loss)(a) | | (1,378 | ) | | (41 | ) | | (49 | ) | | 256 |
| | (29 | ) | | (1,241 | ) |
Balance, March 29, 2015 | | $ | (4,067 | ) | | $ | 476 |
| | $ | (271 | ) | | $ | (5,398 | ) | | $ | 703 |
| | $ | (8,557 | ) |
| |
(a) | Amounts do not include foreign currency translation adjustments attributable to noncontrolling interests of $16 million loss for the first three months of 2015. |
As of March 29, 2015, with respect to derivative financial instruments, the amount of unrealized pre-tax gains estimated to be reclassified into income within the next 12 months is $435 million (which is expected to be offset primarily by losses resulting from reclassification adjustments related to available-for-sale securities).
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 7. Financial Instruments
A. Selected Financial Assets and Liabilities
|
| | | | | | | | |
The following table provides additional information about certain of our financial assets and liabilities: |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | December 31, 2014 |
|
Selected financial assets measured at fair value on a recurring basis(a) | | | | |
Trading equity funds | | $ | 94 |
| | $ | — |
|
Trading debt funds | | 102 |
| | — |
|
Trading securities held in trust(b) | | 85 |
| | 105 |
|
Available-for-sale debt securities(c) | | 34,930 |
| | 39,762 |
|
Available-for-sale money market funds | | 1,883 |
| | 2,174 |
|
Available-for-sale equity securities, excluding money market funds(c) | | 393 |
| | 397 |
|
Derivative financial instruments in a receivable position(d): | | |
| | |
|
Interest rate swaps | | 935 |
| | 801 |
|
Foreign currency swaps | | 577 |
| | 593 |
|
Foreign currency forward-exchange contracts | | 594 |
| | 547 |
|
| | 39,592 |
| | 44,379 |
|
Other selected financial assets | | |
| | |
|
Held-to-maturity debt securities, carried at amortized cost(c), (e) | | 4,323 |
| | 7,255 |
|
Private equity securities, carried at equity-method or at cost(e), (f) | | 1,969 |
| | 1,993 |
|
| | 6,292 |
| | 9,248 |
|
Total selected financial assets | | $ | 45,884 |
| | $ | 53,627 |
|
Selected financial liabilities measured at fair value on a recurring basis(a) | | |
| | |
|
Derivative financial instruments in a liability position(g): | | |
| | |
|
Interest rate swaps | | $ | 72 |
| | $ | 17 |
|
Foreign currency swaps | | 1,342 |
| | 594 |
|
Foreign currency forward-exchange contracts | | 142 |
| | 78 |
|
| | 1,556 |
| | 689 |
|
Other selected financial liabilities(h) | | |
| | |
|
Short-term borrowings, carried at historical proceeds, as adjusted(e) | | 6,555 |
| | 5,141 |
|
Long-term debt, carried at historical proceeds, as adjusted(i), (j) | | 29,370 |
| | 31,541 |
|
| | 35,925 |
| | 36,682 |
|
Total selected financial liabilities | | $ | 37,481 |
| | $ | 37,371 |
|
| |
(a) | We use a market approach in valuing financial instruments on a recurring basis. For additional information, see Note 1C. All of our financial assets and liabilities measured at fair value on a recurring basis use Level 2 inputs in the calculation of fair value, except less than 1% that use Level 1 inputs. |
| |
(b) | Trading securities are equity securities as of March 27, 2015, and debt and equity securities as of December 31, 2014, held in trust for benefits attributable to the former Pharmacia Savings Plus Plan. |
| |
(c) | Gross unrealized gains and losses are not significant. |
| |
(d) | Designated as hedging instruments, except for certain contracts used as offsets; namely, foreign currency forward-exchange contracts with fair values of $114 million as of March 29, 2015; and foreign currency forward-exchange contracts with fair values of $159 million as of December 31, 2014. |
| |
(e) | The differences between the estimated fair values and carrying values of held-to-maturity debt securities, private equity securities at cost and short-term borrowings not measured at fair value on a recurring basis were not significant as of March 29, 2015 or December 31, 2014. The fair value measurements of our held-to-maturity debt securities and our short-term borrowings are based on Level 2 inputs, using a market approach. The fair value measurements of our private equity securities carried at cost are based on Level 3 inputs. |
| |
(f) | Our private equity securities represent investments in the life sciences sector. |
| |
(g) | Designated as hedging instruments, except for certain contracts used as offsets; namely, foreign currency swaps with fair values of $233 million and foreign currency forward-exchange contracts with fair values of $59 million as of March 29, 2015; and foreign currency swaps with fair values of $121 million and foreign currency forward-exchange contracts with fair values of $54 million as of December 31, 2014. |
| |
(h) | Some carrying amounts may include adjustments for discount or premium amortization or for the effect of hedging the interest rate fair value risk associated with certain financial liabilities by interest rate swaps. |
| |
(i) | Includes foreign currency debt with fair values of $557 million as of March 29, 2015 and $560 million as of December 31, 2014, which are used as hedging instruments. |
| |
(j) | The fair value of our long-term debt (not including the current portion of long-term debt) was $34.8 billion as of March 29, 2015 and $36.6 billion as of December 31, 2014. The fair value measurements for our long-term debt are based on Level 2 inputs, using a market approach. Generally, the |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
difference between the fair value of our long-term debt and the amount reported on the condensed consolidated balance sheet is due to a decline in relative market interest rates since the debt issuance.
|
| | | | | | | | |
The following table provides the classification of these selected financial assets and liabilities in our condensed consolidated balance sheets: |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | December 31, 2014 |
|
Assets | | | | |
Cash and cash equivalents | | $ | 1,345 |
| | $ | 1,389 |
|
Short-term investments | | 24,145 |
| | 32,779 |
|
Long-term investments | | 18,289 |
| | 17,518 |
|
Other current assets(a) | | 1,073 |
| | 1,059 |
|
Other noncurrent assets(b) | | 1,032 |
| | 881 |
|
| | $ | 45,884 |
| | $ | 53,627 |
|
Liabilities | | |
| | |
|
Short-term borrowings, including current portion of long-term debt | | $ | 6,555 |
| | $ | 5,141 |
|
Other current liabilities(c) | | 174 |
| | 93 |
|
Long-term debt | | 29,370 |
| | 31,541 |
|
Other noncurrent liabilities(d) | | 1,382 |
| | 596 |
|
| | $ | 37,481 |
| | $ | 37,371 |
|
| |
(a) | As of March 29, 2015, derivative instruments at fair value include interest rate swaps ($1 million), foreign currency swaps ($500 million) and foreign currency forward-exchange contracts ($572 million) and, as of December 31, 2014, include interest rate swaps ($34 million), foreign currency swaps ($494 million) and foreign currency forward-exchange contracts ($531 million). |
| |
(b) | As of March 29, 2015, derivative instruments at fair value include interest rate swaps ($934 million), foreign currency swaps ($76 million) and foreign currency forward-exchange contracts ($22 million) and, as of December 31, 2014, include interest rate swaps ($767 million), foreign currency swaps ($99 million) and foreign currency forward-exchange contracts ($15 million). |
| |
(c) | As of March 29, 2015, derivative instruments at fair value include interest rate swaps ($1 million), foreign currency swaps ($33 million) and foreign currency forward-exchange contracts ($140 million) and, as of December 31, 2014, include interest rate swaps ($1 million), foreign currency swaps ($13 million) and foreign currency forward-exchange contracts ($78 million). |
| |
(d) | As of March 29, 2015, derivative instruments at fair value include interest rate swaps ($71 million), foreign currency swaps ($1.3 billion) and foreign currency forward-exchange contracts ($1 million) and, as of December 31, 2014, include interest rate swaps ($16 million) and foreign currency swaps ($581 million). |
There were no significant impairments of financial assets recognized in any period presented.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
B. Investments in Debt Securities
|
| | | | | | | | | | | | | | | | | | | | |
The following table provides the contractual maturities, or as necessary, the estimated maturities, of the available-for-sale and held-to-maturity debt securities: |
| | Years | | March 29, 2015 |
|
(MILLIONS OF DOLLARS) | | Within 1 |
| | Over 1 to 5 |
| | Over 5 to 10 |
| | Over 10 |
| | Total |
|
Available-for-sale debt securities | | | | | | | | | | |
Western European, Asian and other government debt(a) | | $ | 10,827 |
| | $ | 2,228 |
| | $ | — |
| | $ | — |
| | $ | 13,055 |
|
Corporate debt(b) | | 3,562 |
| | 4,062 |
| | 1,814 |
| | 66 |
| | 9,504 |
|
Western European, Scandinavian and other government agency debt(a) | | 2,295 |
| | 502 |
| | — |
| | — |
| | 2,798 |
|
U.S. government debt | | — |
| | 2,437 |
| | 94 |
| | — |
| | 2,531 |
|
Supranational debt(a) | | 1,084 |
| | 854 |
| | — |
| | — |
| | 1,938 |
|
Federal Home Loan Mortgage Corporation and Federal National Mortgage Association asset-backed securities | | 19 |
| | 1,902 |
| | 8 |
| | 5 |
| | 1,933 |
|
Government National Mortgage Association and other U.S. government guaranteed asset-backed securities | | 290 |
| | 699 |
| | — |
| | — |
| | 989 |
|
Other asset-backed debt(c) | | 914 |
| | 959 |
| | 8 |
| | — |
| | 1,882 |
|
Reverse repurchase agreements(d) | | 300 |
| | — |
| | — |
| | — |
| | 300 |
|
Held-to-maturity debt securities | | | | | | |
| | | | |
|
Time deposits, corporate debt and other(a) | | 2,865 |
| | 4 |
| | 3 |
| | — |
| | 2,872 |
|
Western European and other government debt(a) | | 1,451 |
| | — |
| | — |
| | — |
| | 1,451 |
|
Total debt securities | | $ | 23,608 |
| | $ | 13,647 |
| | $ | 1,927 |
| | $ | 71 |
| | $ | 39,253 |
|
| |
(a) | Issued by governments, government agencies or supranational entities, as applicable, all of which are investment-grade. |
| |
(b) | Issued by a diverse group of corporations, largely consisting of financial institutions, virtually all of which are investment-grade. |
| |
(c) | Includes loan-backed, receivable-backed, and mortgage-backed securities, all of which are investment-grade and in senior positions in the capital structure of the security. Loan-backed securities are collateralized by senior secured obligations of a diverse pool of companies or student loans, and receivable-backed securities are collateralized by credit cards receivables. Mortgage-backed securities are collateralized by diversified pools of residential and commercial mortgages. |
| |
(d) | Involving U.S. securities. |
C. Short-Term Borrowings
Short-term borrowings include amounts for commercial paper of $3.6 billion as of March 29, 2015 and $570 million as of December 31, 2014.
D. Derivative Financial Instruments and Hedging Activities
Foreign Exchange Risk
As of March 29, 2015, the aggregate notional amount of foreign exchange derivative financial instruments hedging or offsetting foreign currency exposures was $36.3 billion. The derivative financial instruments primarily hedge or offset exposures in the euro, Japanese yen, U.K. pound and Swiss franc. The maximum length of time over which we are hedging future foreign exchange cash flow relates to our $2.2 billion U.K. pound debt maturing in 2038.
Interest Rate Risk
As of March 29, 2015, the aggregate notional amount of interest rate derivative financial instruments was $20.4 billion. The derivative financial instruments primarily hedge U.S. dollar and euro fixed-rate debt.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
|
| | | | | | | | | | | | | | | | | | | | | | | | |
The following table provides information about the gains/(losses) incurred to hedge or offset operational foreign exchange or interest rate risk: |
| | Amount of Gains/(Losses) Recognized in OID(a), (b), (c) | | Amount of Gains/(Losses) Recognized in OCI (Effective Portion)(a), (d) | | Amount of Gains/(Losses) Reclassified from OCI into OID (Effective Portion)(a), (d) |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | March 30, 2014 |
| | March 29, 2015 |
| | March 30, 2014 |
| | March 29, 2015 |
| | March 30, 2014 |
|
Three Months Ended | | | | | | | | | | | | |
Derivative Financial Instruments in Cash Flow Hedge Relationships: | | | | | | | | | | | | |
Foreign currency swaps | | $ | — |
| | $ | — |
| | $ | (732 | ) | | $ | (15 | ) | | $ | (607 | ) | | $ | 9 |
|
Foreign currency forward-exchange contracts | | — |
| | — |
| | 417 |
| | (43 | ) | | 373 |
| | (21 | ) |
Derivative Financial Instruments in Net Investment Hedge Relationships: | | |
| | |
| | |
| | |
| | |
| | |
|
Foreign currency swaps | | — |
| | — |
| | — |
| | (8 | ) | | — |
| | — |
|
Foreign currency forward-exchange contracts | | 2 |
| | — |
| | 249 |
| | — |
| | — |
| | — |
|
| | | | | | | | | | | | |
Derivative Financial Instruments Not Designated as Hedges: | | |
| | |
| | |
| | |
| | |
| | |
|
Foreign currency forward-exchange contracts | | (41 | ) | | (12 | ) | | — |
| | — |
| | — |
| | — |
|
Foreign currency swaps | | 1 |
| | (3 | ) | | — |
| | — |
| | — |
| | — |
|
| | | | | | | | | | | | |
Non-Derivative Financial Instruments in Net Investment Hedge Relationships: | | |
| | |
| | |
| | |
| | |
| | |
|
Foreign currency long-term debt | | — |
| | — |
| | (3 | ) | | (14 | ) | | — |
| | — |
|
All other net | | — |
| | (3 | ) | | — |
| | — |
| | — |
| | — |
|
| | $ | (38 | ) | | $ | (18 | ) | | $ | (68 | ) | | $ | (80 | ) | | $ | (234 | ) | | $ | (12 | ) |
| |
(a) | OID = Other (income)/deductions—net, included in Other (income)/deductions—net in the condensed consolidated statements of income. OCI = Other comprehensive income/(loss), included in the condensed consolidated statements of comprehensive income. |
| |
(b) | Also, includes gains and losses attributable to derivative instruments designated and qualifying as fair value hedges, as well as the offsetting gains and losses attributable to the hedged items in such hedging relationships. |
| |
(c) | There was no significant ineffectiveness for any period presented. |
| |
(d) | For derivative financial instruments in cash flow hedge relationships, the effective portion is included in Other comprehensive loss––Unrealized holding losses on derivative financial instruments, net. For derivative financial instruments in net investment hedge relationships and for foreign currency debt designated as hedging instruments, the effective portion is included in Other comprehensive loss––Foreign currency translation adjustments. |
For information about the fair value of our derivative financial instruments, and the impact on our condensed consolidated balance sheets, see Note 7A. Certain of our derivative instruments are covered by associated credit-support agreements that have credit-risk-related contingent features designed to reduce our counterparties’ exposure to our risk of defaulting on amounts owed. As of March 29, 2015, the aggregate fair value of these derivative instruments that are in a net liability position was $729 million, for which we have posted collateral of $710 million in the normal course of business. These features include the requirement to pay additional collateral in the event of a downgrade in our debt ratings. If there had been a downgrade to below an A rating by Standard and Poor's (S&P) or the equivalent rating by Moody's Investors Service, on March 29, 2015, we would have been required to post an additional $21 million of collateral to our counterparties. The collateral advanced receivables are reported in Short-term investments.
E. Credit Risk
On an ongoing basis, we review the creditworthiness of counterparties to our foreign exchange and interest rate agreements and do not expect to incur a significant loss from failure of any counterparties to perform under the agreements. There are no significant concentrations of credit risk related to our financial instruments with any individual counterparty. As of March 29, 2015, we had $3.1 billion due from a well-diversified, highly rated group (S&P ratings of mostly A or better) of bank counterparties around the world. For details about our investments, see Note 7B above.
In general, there is no requirement for collateral from customers. However, derivative financial instruments are executed under master netting agreements with financial institutions and these agreements contain provisions that provide for the ability for collateral payments, depending on levels of exposure, our credit rating and the credit rating of the counterparty. As of March 29, 2015, we received cash collateral of $1.4 billion from various counterparties. The collateral primarily supports the approximate
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
fair value of our derivative contracts. With respect to the collateral received, which is included in Cash and cash equivalents, the obligations are reported in Short-term borrowings, including current portion of long-term debt.
Note 8. Inventories
|
| | | | | | | | |
The following table provides the components of Inventories: |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | December 31, 2014 |
|
Finished goods | | $ | 1,898 |
| | $ | 1,905 |
|
Work-in-process | | 3,414 |
| | 3,248 |
|
Raw materials and supplies | | 475 |
| | 510 |
|
Inventories | | $ | 5,786 |
| | $ | 5,663 |
|
Noncurrent inventories not included above(a) | | $ | 467 |
| | $ | 425 |
|
| |
(a) | Included in Other noncurrent assets. There are no recoverability issues associated with these amounts. |
Note 9. Identifiable Intangible Assets and Goodwill
A. Identifiable Intangible Assets
Balance Sheet Information
|
| | | | | | | | | | | | | | | | | | | | | | | | |
The following table provides the components of Identifiable intangible assets: |
| | March 29, 2015 | | December 31, 2014 |
(MILLIONS OF DOLLARS) | | Gross Carrying Amount |
| | Accumulated Amortization |
| | Identifiable Intangible Assets, less Accumulated Amortization |
| | Gross Carrying Amount |
| | Accumulated Amortization |
| | Identifiable Intangible Assets, less Accumulated Amortization |
|
Finite-lived intangible assets | | | | | | | | | | | | |
Developed technology rights | | $ | 70,251 |
| | $ | (44,759 | ) | | $ | 25,493 |
| | $ | 70,946 |
| | $ | (44,694 | ) | | $ | 26,252 |
|
Brands | | 1,910 |
| | (869 | ) | | 1,041 |
| | 1,951 |
| | (855 | ) | | 1,096 |
|
Licensing agreements and other | | 1,057 |
| | (897 | ) | | 160 |
| | 991 |
| | (832 | ) | | 159 |
|
| | 73,219 |
| | (46,525 | ) | | 26,694 |
| | 73,887 |
| | (46,381 | ) | | 27,506 |
|
Indefinite-lived intangible assets | | | | | | | | | | | | |
Brands and other | | 7,206 |
| |
|
| | 7,206 |
| | 7,273 |
| |
|
| | 7,273 |
|
In-process research and development | | 434 |
| |
|
| | 434 |
| | 387 |
| |
|
| | 387 |
|
| | 7,640 |
| |
|
| | 7,640 |
| | 7,660 |
| |
|
| | 7,660 |
|
Identifiable intangible assets(a) | | $ | 80,859 |
| | $ | (46,525 | ) | | $ | 34,334 |
| | $ | 81,547 |
| | $ | (46,381 | ) | | $ | 35,166 |
|
| |
(a) | The decrease in identifiable intangible assets, less accumulated amortization, is primarily related to amortization, partially offset by assets acquired as part of the acquisition of Baxter's portfolio of marketed vaccines. For information about the assets acquired as part of the acquisition of Baxter's portfolio of marketed vaccines, see Note 2A. |
|
| | | | | | | | | |
Our identifiable intangible assets are associated with the following segments, as a percentage of total identifiable intangible assets, less accumulated amortization: |
| | March 29, 2015 |
| | GIP | | VOC | | GEP |
Developed technology rights | | 31 | % | | 36 | % | | 33 | % |
Brands, finite-lived | | — | % | | 80 | % | | 20 | % |
Brands, indefinite-lived | | — | % | | 69 | % | | 31 | % |
In-process research and development | | 7 | % | | 38 | % | | 55 | % |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Amortization
Amortization expense related to finite-lived acquired intangible assets that contribute to our ability to sell, manufacture, research, market and distribute products, compounds and intellectual property is included in Amortization of intangible assets, as these intangible assets benefit multiple business functions. Amortization expense related to intangible assets that are associated with a single function is included in Cost of sales, Selling, informational and administrative expenses and/or Research and development expenses, as appropriate. Total amortization expense for finite-lived intangible assets was $1.0 billion for the first quarter of 2015 and $1.1 billion for the first quarter of 2014.
Impairment Charges
For information about impairments of intangible assets, see Note 4.
For IPR&D assets, the risk of failure is significant and there can be no certainty that these assets ultimately will yield successful products. The nature of the biopharmaceutical business is high-risk and, as such, we expect that many of these IPR&D assets will become impaired and be written off at some time in the future.
B. Goodwill |
| | | | | | | | | | | | | | | | |
The following table provides the components of and changes in the carrying amount of Goodwill: |
(MILLIONS OF DOLLARS) | | GIP |
| | VOC |
| | GEP |
| | Total |
|
Balance, December 31, 2014 | | $ | 13,032 |
| | $ | 11,398 |
| | $ | 17,639 |
| | $ | 42,069 |
|
Additions | | — |
| | 37 |
| | — |
| | 37 |
|
Other(a) | | (69 | ) | | (90 | ) | | (94 | ) | | (252 | ) |
Balance, March 29, 2015 | | $ | 12,963 |
| | $ | 11,345 |
| | $ | 17,545 |
| | $ | 41,854 |
|
| |
(a) | Primarily reflects the impact of foreign exchange. |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 10. Pension and Postretirement Benefit Plans
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
The following table provides the components of net periodic benefit cost: |
| | Pension Plans | | | | |
| | U.S. Qualified(a) | | U.S. Supplemental (Non-Qualified)(b) | | International(c) | | Postretirement Plans(d) |
(MILLIONS OF DOLLARS) | | March 29, 2015 |
| | March 30, 2014 |
| | March 29, 2015 |
| | March 30, 2014 |
| | March 29, 2015 |
| | March 30, 2014 |
| | March 29, 2015 |
| | March 30, 2014 |
|
Three Months Ended | | | | | | | | | | | | | | | | |
Net periodic benefit cost: | | | | | | | | | | | | | | | | |
Service cost | | $ | 72 |
| | $ | 64 |
| | $ | 6 |
| | $ | 5 |
| | $ | 48 |
| | $ | 52 |
| | $ | 14 |
| | $ | 14 |
|
Interest cost | | 169 |
| | 175 |
| | 14 |
| | 15 |
| | 79 |
| | 100 |
| | 32 |
| | 42 |
|
Expected return on plan assets | | (272 | ) | | (263 | ) | | — |
| | — |
| | (106 | ) | | (114 | ) | | (13 | ) | | (16 | ) |
Amortization of: | | |
| | |
| | |
| | |
| | | | |
| | |
| | |
|
Actuarial losses | | 83 |
| | 16 |
| | 12 |
| | 7 |
| | 32 |
| | 25 |
| | 9 |
| | 1 |
|
Prior service credits | | (2 | ) | | (2 | ) | | — |
| | — |
| | (2 | ) | | (2 | ) | | (31 | ) | | (14 | ) |
Curtailments | | 2 |
| | 2 |
| | — |
| | — |
| | — |
| | (1 | ) | | (10 | ) | | (3 | ) |
Settlements | | 26 |
| | 9 |
| | 15 |
| | 11 |
| | — |
| | 1 |
| | — |
| | — |
|
Special termination benefits | | — |
| | — |
| | — |
| | — |
| | — |
| | 2 |
| | — |
| | — |
|
| | $ | 78 |
| | $ | 1 |
| | $ | 45 |
| | $ | 38 |
| | $ | 51 |
| | $ | 63 |
| | $ | 1 |
| | $ | 24 |
|
| |
(a) | The increase in net periodic benefit costs for the three months ended March 29, 2015, compared to the three months ended March 30, 2014, for our U.S. qualified pension plans was primarily driven by (i) the increase in the amounts amortized for actuarial losses resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation (which increased the amount of deferred actuarial losses) and, to a lesser extent, a 2014 change in mortality assumptions (reflecting a longer life expectancy for plan participants), and (ii) higher settlement activity. The aforementioned increases were partially offset by (i) a greater expected return on plan assets resulting from an increased plan asset base due to a voluntary contribution of $1.0 billion made at the beginning of January 2015, which in turn was partially offset by a decrease in the expected rate of return on plan assets from 8.5% to 8.25%, and (ii) lower interest costs resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation. |
| |
(b) | The increase in net periodic benefit costs for the three months ended March 29, 2015, compared to the three months ended March 30, 2014, for our U.S. supplemental (non-qualified) pension plans was primarily driven by (i) the increase in the amounts amortized for actuarial losses resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation and, to a lesser extent, a 2014 change in mortality assumptions (reflecting a longer life expectancy for plan participants), and (ii) higher settlement activity. |
| |
(c) | The decrease in net periodic benefit costs for the three months ended March 29, 2015, compared to the three months ended March 30, 2014, for our international pension plans was primarily driven by (i) the decrease in interest cost resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation, (ii) a decrease in service cost related to changes in actuarial assumptions (lower inflation and lower rate of wage increases) and the U.K. pension plan freeze in 2014, which offset the impact of the decrease in 2014, in the discount rate used to determine the benefit obligation (the effect of which is an increase in service costs). The aforementioned decreases to net periodic benefit costs were partially offset by (i) a decrease in the expected return on plan assets due to a lower expected rate of return on plan assets and (ii) an increase in the amounts amortized for actuarial losses resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation. |
| |
(d) | The decrease in net periodic benefit costs for the three months ended March 29, 2015, compared to the three months ended March 30, 2014, for our postretirement plans was primarily driven by (i) the increase in the amounts amortized for prior service credits and (ii) an increase in curtailment gain resulting from the implementation of changes related to the employer group waiver plan, which went into effect on January 1, 2015, as well as (iii) a decrease in interest cost resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation. The aforementioned decreases were partially offset by an increase in actuarial losses resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation. |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
As of and for the three months ended March 29, 2015, we contributed and expect to contribute from our general assets as follows: |
| | | | | | | | | | | | | | | | |
| | Pension Plans | | |
(MILLIONS OF DOLLARS) | | U.S. Qualified | | U.S. Supplemental (Non-Qualified) | | International | | Postretirement Plans |
Contributions from our general assets for the three months ended March 29, 2015(a) | | $ | 1,000 |
| | $ | 72 |
| | $ | 58 |
| | $ | (81 | ) |
Expected contributions from our general assets during 2015(b) | | $ | 1,000 |
| | $ | 136 |
| | $ | 240 |
| | $ | 86 |
|
| |
(a) | Contributions to the postretirement plans were offset by reimbursements of approximately $133 million received for eligible 2014 prescription expenses for certain retirees. |
| |
(b) | Contributions expected to be made for 2015 are inclusive of amounts contributed during the three months ended March 29, 2015, including the $1.0 billion voluntary contribution that was made in January 2015 for the U.S. Qualified plan. The U.S. supplemental (non-qualified) pension plan, international pension plan and the postretirement plan contributions from our general assets include direct employer benefit payments. |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 11. Earnings Per Common Share Attributable to Common Shareholders
|
| | | | | | | | |
The following table provides the detailed calculation of Earnings per common share (EPS): |
| | Three Months Ended |
(IN MILLIONS) | | March 29, 2015 |
| | March 30, 2014 |
|
EPS Numerator––Basic | | | | |
Income from continuing operations | | $ | 2,376 |
| | $ | 2,265 |
|
Less: Net income attributable to noncontrolling interests | | 6 |
| | 9 |
|
Income from continuing operations attributable to Pfizer Inc. | | 2,371 |
| | 2,256 |
|
Less: Preferred stock dividends––net of tax | | — |
| | — |
|
Income from continuing operations attributable to Pfizer Inc. common shareholders | | 2,370 |
| | 2,256 |
|
Discontinued operations––net of tax | | 5 |
| | 73 |
|
Less: Discontinued operations––net of tax, attributable to noncontrolling interests | | — |
| | — |
|
Discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders | | 5 |
| | 73 |
|
Net income attributable to Pfizer Inc. common shareholders | | $ | 2,375 |
| | $ | 2,329 |
|
EPS Numerator––Diluted | | |
| | |
|
Income from continuing operations attributable to Pfizer Inc. common shareholders and assumed conversions | | $ | 2,371 |
| | $ | 2,256 |
|
Discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders and assumed conversions | | 5 |
| | 73 |
|
Net income attributable to Pfizer Inc. common shareholders and assumed conversions | | $ | 2,376 |
| | $ | 2,329 |
|
EPS Denominator | | |
| | |
|
Weighted-average number of common shares outstanding––Basic | | 6,203 |
| | 6,389 |
|
Common-share equivalents: stock options, stock issuable under employee compensation plans, convertible preferred stock and accelerated share repurchase agreement | | 90 |
| | 87 |
|
Weighted-average number of common shares outstanding––Diluted | | 6,292 |
| | 6,476 |
|
Stock options that had exercise prices greater than the average market price of our common stock issuable under employee compensation plans(a) | | 34 |
| | 43 |
|
| |
(a) | These common stock equivalents were outstanding for the three months ended March 29, 2015 and March 30, 2014, but were not included in the computation of diluted EPS for those periods because their inclusion would have had an anti-dilutive effect. |
Note 12. Commitments and Contingencies
We and certain of our subsidiaries are subject to numerous contingencies arising in the ordinary course of business. For a discussion of our tax contingencies, see Note 5B.
On February 9, 2015, we entered into an accelerated share repurchase agreement with Goldman, Sachs & Co. (GS&Co.) to repurchase $5 billion of our common stock. Pursuant to the terms of the agreement, approximately 150 million shares of our common stock were received by us on February 11, 2015. At settlement of the agreement, which is expected to occur during or prior to the third quarter of 2015, GS&Co. may be required to deliver additional shares of common stock to us, or, under certain circumstances, we may be required to deliver shares of our common stock or may elect to make a cash payment to GS&Co., with the number of shares to be delivered or the amount of such payment based on the difference between the volume-weighted average price, less a discount, of our common stock during the term of the transaction and the initial $5 billion paid. This agreement was entered into pursuant to our previously announced share repurchase authorization.
A. Legal Proceedings
Our non-tax contingencies include, but are not limited to, the following:
| |
• | Patent litigation, which typically involves challenges to the coverage and/or validity of our patents on various products, processes or dosage forms. We are the plaintiff in the vast majority of these actions. An adverse outcome in actions in which we are the plaintiff could result in a loss of patent protection for the drug at issue, a significant loss of revenues from that drug and impairments of any associated assets. |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
| |
• | Product liability and other product-related litigation, which can include personal injury, consumer, off-label promotion, securities-law, antitrust and breach of contract claims, among others, often involves highly complex issues relating to medical causation, label warnings and reliance on those warnings, scientific evidence and findings, actual, provable injury and other matters. |
| |
• | Commercial and other matters, which can include merger-related and product-pricing claims and environmental claims and proceedings, can involve complexities that will vary from matter to matter. |
| |
• | Government investigations, which often are related to the extensive regulation of pharmaceutical companies by national, state and local government agencies in the U.S. and in other countries. |
Certain of these contingencies could result in losses, including damages, fines and/or civil penalties, and/or criminal charges, which could be substantial.
We believe that our claims and defenses in these matters are substantial, but litigation is inherently unpredictable and excessive verdicts do occur. We do not believe that any of these matters will have a material adverse effect on our financial position. However, we could incur judgments, enter into settlements or revise our expectations regarding the outcome of certain matters, and such developments could have a material adverse effect on our results of operations in the period in which the amounts are accrued and/or our cash flows in the period in which the amounts are paid.
We have accrued for losses that are both probable and reasonably estimable. Substantially all of our contingencies are subject to significant uncertainties and, therefore, determining the likelihood of a loss and/or the measurement of any loss can be complex. Consequently, we are unable to estimate the range of reasonably possible loss in excess of amounts accrued. Our assessments are based on estimates and assumptions that have been deemed reasonable by management, but the assessment process relies heavily on estimates and assumptions that may prove to be incomplete or inaccurate, and unanticipated events and circumstances may occur that might cause us to change those estimates and assumptions.
Amounts recorded for legal and environmental contingencies can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions.
The principal pending matters to which we are a party are discussed below. In determining whether a pending matter is a principal matter, we consider both quantitative and qualitative factors in order to assess materiality, such as, among other things, the amount of damages and the nature of any other relief sought in the proceeding, if such damages and other relief are specified; our view of the merits of the claims and of the strength of our defenses; whether the action purports to be a class action and our view of the likelihood that a class will be certified by the court; the jurisdiction in which the proceeding is pending; any experience that we or, to our knowledge, other companies have had in similar proceedings; whether disclosure of the action would be important to a reader of our financial statements, including whether disclosure might change a reader’s judgment about our financial statements in light of all of the information about the Company that is available to the reader; the potential impact of the proceeding on our reputation; and the extent of public interest in the matter. In addition, with respect to patent matters, we consider, among other things, the financial significance of the product protected by the patent. As a result of considering qualitative factors in our determination of principal matters, there are some matters discussed below with respect to which management believes that the likelihood of possible loss in excess of amounts accrued is remote.
A1. Legal Proceedings––Patent Litigation
Like other pharmaceutical companies, we are involved in numerous suits relating to our patents, including but not limited to, those discussed below. Most of the suits involve claims by generic drug manufacturers that patents covering our products, processes or dosage forms are invalid and/or do not cover the product of the generic drug manufacturer. Also, counterclaims, as well as various independent actions, have been filed claiming that our assertions of, or attempts to enforce, our patent rights with respect to certain products constitute unfair competition and/or violations of antitrust laws. In addition to the challenges to the U.S. patents on a number of our products that are discussed below, we note that the patent rights to certain of our products are being challenged in various other countries. Also, our licensing and collaboration partners face challenges by generic drug manufacturers to patents covering several of their products that may impact our licenses or co-promotion rights to such products.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Actions In Which We Are The Plaintiff
Viagra (sildenafil)
In October 2010, we filed a patent-infringement action with respect to Viagra in the U.S. District Court for the Southern District of New York against Apotex Inc. and Apotex Corp., Mylan Pharmaceuticals Inc. (Mylan) and Mylan Inc. and Actavis, Inc. These generic drug manufacturers have filed abbreviated new drug applications with the FDA seeking approval to market their generic versions of Viagra. They assert the invalidity and non-infringement of the Viagra method-of-use patent, which expires in 2020 (including the six-month pediatric exclusivity period resulting from the Company’s conduct of clinical studies to evaluate Revatio in the treatment of pediatric patients with pulmonary arterial hypertension; Viagra and Revatio have the same active ingredient, sildenafil).
In May and June 2011, Watson Laboratories Inc. (Watson) and Hetero Labs Limited (Hetero), respectively, notified us that they had filed abbreviated new drug applications with the FDA seeking approval to market their generic versions of Viagra. Each asserts the invalidity and non-infringement of the Viagra method-of-use patent. In June and July 2011, we filed actions against Watson and Hetero, respectively, in the U.S. District Court for the Southern District of New York asserting the validity and infringement of the Viagra method-of-use patent.
In April 2015, we entered into settlement agreements with each of Mylan, Mylan Inc., Watson, Actavis, Inc., Apotex Inc. and Apotex Corp. pursuant to which we granted licenses to the method-of-use patent permitting Mylan, Mylan Inc., Watson, Actavis, Inc., Apotex Inc. and Apotex Corp. to launch generic versions of Viagra in the U.S. beginning on or after December 11, 2017.
Sutent (sunitinib malate)
In May 2010, Mylan notified us that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Sutent and challenging on various grounds the Sutent basic patent, which expires in 2021, and two other patents that expire in 2020 and 2021, respectively. In June 2010, we filed suit against Mylan in the U.S. District Court for the District of Delaware asserting the infringement of those three patents. The patent expiring in 2020 was dismissed from the case prior to trial. In October 2014, the court held that the two patents expiring in 2021 were valid and infringed. In October 2014, Mylan appealed the decision to the U.S. Court of Appeals for the Federal Circuit.
EpiPen
In July 2010, King Pharmaceuticals, Inc. (King), which we acquired in 2011 and is a wholly owned subsidiary, brought a patent-infringement action against Sandoz, Inc., a division of Novartis AG (Sandoz), in the U.S. District Court for the District of New Jersey in connection with Sandoz's abbreviated new drug application with the FDA that seeks approval to market an epinephrine injectable product. Sandoz is challenging patents, which expire in 2025, covering the next-generation autoinjector for use with epinephrine that is sold under the EpiPen brand name.
Celebrex (celecoxib)
In March 2013, the U.S. Patent and Trademark Office granted us a reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex. The reissue patent, including the six-month pediatric exclusivity period, expires in December 2015. On the date that the reissue patent was granted, we filed suit against Teva Pharmaceuticals USA, Inc. (Teva USA), Mylan, Watson (as predecessor to Actavis plc), Lupin Pharmaceuticals USA, Inc. (Lupin), Apotex Corp. and Apotex Inc. in the U.S. District Court for the Eastern District of Virginia, asserting the infringement of the reissue patent. Each of the defendant generic drug companies had previously filed an abbreviated new drug application with the FDA seeking approval to market a generic version of celecoxib beginning in May 2014, upon the expiration of the basic patent (including the six-month pediatric exclusivity period) for celecoxib. In March 2014, the court granted the defendants’ motion for summary judgment, invalidating the reissue patent. In May 2014, we appealed the District Court's decision to the U.S. Court of Appeals for the Federal Circuit.
In April 2014, we entered into settlement agreements with two of the defendants, Teva USA and Watson, pursuant to which we granted licenses to the reissue patent permitting Teva USA and Watson to launch generic versions of celecoxib in the U.S. beginning in December 2014. In June 2014 and October 2014, we entered into settlement agreements with Mylan and Lupin, respectively, pursuant to which we granted licenses to the reissue patent permitting Mylan and Lupin to launch generic versions of celecoxib in the U.S. beginning in December 2014. In December 2014, Teva USA, Watson, Mylan and Lupin commenced marketing of generic versions of celecoxib.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Toviaz (fesoterodine)
We have an exclusive, worldwide license to market Toviaz from UCB Pharma GmbH, which owns the patents relating to Toviaz.
Beginning in May 2013, several generic drug manufacturers notified us that they had filed abbreviated new drug applications with the FDA seeking approval to market generic versions of Toviaz and asserting the invalidity, unenforceability and/or non-infringement of all of our patents for Toviaz that are listed in the Orange Book. Beginning in June 2013, we filed actions against all of those generic drug manufacturers in the U.S. District Court for the District of Delaware, asserting the infringement of five of the patents for Toviaz: three composition-of-matter patents and a method-of-use patent that expire in 2019; and a patent covering salts of fesoterodine that expires in 2022.
Tygacil (tigecycline)
In September 2013, Apotex Inc. notified us that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Tygacil. Apotex Inc. asserts the non-infringement of the polymorph patent for Tygacil that expires in 2030, but has not challenged the basic patent, which expires in 2016. In September 2013, we filed suit against Apotex Inc. in the U.S. District Court for the District of Delaware asserting the infringement of the polymorph patent. In February 2015, the suit was dismissed.
In May 2014, CFT Pharmaceuticals LLC (CFT) notified us that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Tygacil. CFT asserts the invalidity and non-infringement of (i) the polymorph patent for Tygacil and (ii) the formulation patent for Tygacil that expires in 2029, but has not challenged the basic patent. In June 2014, we filed suit against CFT in the U.S. District Court for the District of Delaware asserting the validity and infringement of the polymorph patent and the formulation patent for Tygacil.
In May 2014, Aurobindo Pharma Limited (Aurobindo) notified us that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Tygacil. Aurobindo asserts the invalidity and non-infringement of (i) the polymorph patent for Tygacil, and (ii) the formulation patent for Tygacil, but has not challenged the basic patent. In July 2014, we filed suit against Aurobindo in the U.S. District Court for the District of Delaware, asserting the validity and infringement of the polymorph patent and the formulation patent for Tygacil.
Action In Which Our Licensing Partner Is The Plaintiff
Nexium 24HR (esomeprazole)
We have an exclusive license to market in the U.S. the over-the-counter (OTC) version of Nexium from AstraZeneca (Nexium 24HR). Beginning in October 2014, Actavis Laboratories FL, Inc., and then subsequently Andrx Labs, LLC (Andrx), and Perrigo Company plc (Perrigo), notified us that they had filed abbreviated new drug applications with the FDA seeking approval to market generic versions of Nexium 24HR prior to the expiration of one or more of AstraZeneca’s patents listed in the FDA Orange Book for Nexium 24HR. In November 2014, December 2014 and February 2015, AstraZeneca filed actions against Actavis Laboratories FL, Inc., Andrx and Perrigo, respectively, in the U.S. District Court for the District of New Jersey asserting the infringement of the challenged patents. We are not a party to AstraZeneca’s patent-infringement action.
Action In Which We Are The Defendant
Effexor XR (venlafaxine HCI)
In 2006, Wyeth and Wyeth Canada Limited (the Wyeth companies) filed an action in the Federal Court in Canada against Ratiopharm Inc. (Ratiopharm) seeking to prevent Ratiopharm from obtaining approval in Canada for its generic version of Effexor XR prior to the expiration of one of the Wyeth companies’ patents. As a result of that action, Ratiopharm was enjoined from obtaining regulatory approval for its generic product. However, in August 2007, the Federal Court of Appeal in Canada ruled that the patent at issue could not be asserted against Ratiopharm under the applicable Canadian regulations governing approvals, and it dismissed the Wyeth companies’ action.
Following the dismissal, in 2007, Ratiopharm filed an action in the Federal Court in Canada seeking damages from the Wyeth companies for preventing Ratiopharm from marketing its generic version of Effexor XR in Canada from January 2006 through August 2007. The Federal Court dismissed Ratiopharm’s action in 2011, but the Federal Court of Appeal reinstated it in 2012. In 2011 and 2012, Pfizer made payments to Teva Canada Limited, which had acquired Ratiopharm, totaling Canadian dollars 52.5 million in partial settlement of this action.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The trial in this action was held in January 2014, and the court issued various findings in March 2014. On June 30, 2014, the Federal Court in Canada issued a judgment based on those findings, awarding Teva Canada Limited damages of approximately Canadian dollars 125 million, consisting of compensatory damages, pre-judgment interest and legal costs. This judgment was satisfied by Pfizer Canada Inc., as successor to the Wyeth companies, in July 2014. In September 2014, Pfizer Canada Inc. appealed the judgment.
A2. Legal Proceedings––Product Litigation
Like other pharmaceutical companies, we are defendants in numerous cases, including but not limited to those discussed below, related to our pharmaceutical and other products. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss.
Asbestos
Between 1967 and 1982, Warner-Lambert owned American Optical Corporation, which manufactured and sold respiratory protective devices and asbestos safety clothing. In connection with the sale of American Optical in 1982, Warner-Lambert agreed to indemnify the purchaser for certain liabilities, including certain asbestos-related and other claims. As of March 29, 2015, approximately 59,000 claims naming American Optical and numerous other defendants were pending in various federal and state courts seeking damages for alleged personal injury from exposure to asbestos and other allegedly hazardous materials. Warner-Lambert was acquired by Pfizer in 2000 and is now a wholly owned subsidiary of Pfizer. Warner-Lambert is actively engaged in the defense of, and will continue to explore various means of resolving, these claims.
Numerous lawsuits are pending against Pfizer in various federal and state courts seeking damages for alleged personal injury from exposure to products containing asbestos and other allegedly hazardous materials sold by Gibsonburg Lime Products Company (Gibsonburg). Gibsonburg was acquired by Pfizer in the 1960s and sold products containing small amounts of asbestos until the early 1970s.
There also are a small number of lawsuits pending in various federal and state courts seeking damages for alleged exposure to asbestos in facilities owned or formerly owned by Pfizer or its subsidiaries.
Celebrex and Bextra
Beginning in late 2004, several purported class actions were filed in federal and state courts alleging that Pfizer and certain of our current and former officers violated federal securities laws by misrepresenting the safety of Celebrex and Bextra. In June 2005, the federal actions were transferred for consolidated pre-trial proceedings to a Multi-District Litigation (In re Pfizer Inc. Securities, Derivative and “ERISA” Litigation MDL-1688) in the U.S. District Court for the Southern District of New York. In March 2012, the court in the Multi-District Litigation certified a class consisting of all persons who purchased or acquired Pfizer stock between October 31, 2000 and October 19, 2005. In May 2014, the court in the Multi-District Litigation granted Pfizer’s motion to exclude the testimony of the plaintiffs’ loss causation and damages expert. We subsequently filed a motion for summary judgment seeking dismissal of the litigation, and the plaintiffs filed a motion for leave to submit an amended report by their expert. In July 2014, the court denied the plaintiffs’ motion for leave to submit an amended report, and granted our motion for summary judgment, dismissing the plaintiffs’ claims in their entirety. In August 2014, the plaintiffs appealed the District Court’s decision to the U.S. Court of Appeals for the Second Circuit.
Various Drugs: Off-Label Promotion Action
In May 2010, a purported class action was filed in the U.S. District Court for the Southern District of New York against Pfizer and several of our current and former officers. The complaint alleges that the defendants violated federal securities laws by making or causing Pfizer to make false statements, and by failing to disclose or causing Pfizer to fail to disclose material information concerning the alleged off-label promotion of certain pharmaceutical products, alleged payments to physicians to promote the sale of those products and government investigations related thereto. Plaintiffs seek damages in an unspecified amount. In March 2012, the court certified a class consisting of all persons who purchased Pfizer common stock in the U.S. or on U.S. stock exchanges between January 19, 2006 and January 23, 2009 and were damaged as a result of the decline in the price of Pfizer common stock allegedly attributable to the claimed violations. In January 2015, the parties reached an agreement in principle to resolve the matter for $400 million. In March 2015, the court preliminarily approved the settlement.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Effexor
A number of individual lawsuits and multi-plaintiff lawsuits have been filed against us and/or our subsidiaries in various federal and state courts alleging personal injury as a result of the purported ingestion of Effexor. Among other types of actions, the Effexor personal injury litigation includes actions alleging a variety of birth defects as a result of the purported ingestion of Effexor by women during pregnancy. Plaintiffs in these birth-defect actions seek compensatory and punitive damages. In August 2013, the federal birth-defect cases were transferred for consolidated pre-trial proceedings to a Multi-District Litigation (In re Effexor (Venlafaxine Hydrochloride) Products Liability Litigation MDL-2458) in the U.S. District Court for the Eastern District of Pennsylvania.
Beginning in May 2011, actions, including purported class actions, were filed in various federal courts against Wyeth and, in certain of the actions, affiliates of Wyeth and certain other defendants relating to Effexor XR, which is the extended-release formulation of Effexor. The plaintiffs in each of the class actions seek to represent a class consisting of all persons in the U.S. and its territories who directly purchased, indirectly purchased or reimbursed patients for the purchase of Effexor XR or generic Effexor XR from any of the defendants from June 14, 2008 until the time the defendants’ allegedly unlawful conduct ceased. The plaintiffs in all of the actions allege delay in the launch of generic Effexor XR in the U.S. and its territories, in violation of federal antitrust laws and, in certain of the actions, the antitrust, consumer protection and various other laws of certain states, as the result of Wyeth fraudulently obtaining and improperly listing certain patents for Effexor XR, enforcing certain patents for Effexor XR, and entering into a litigation settlement agreement with a generic drug manufacturer with respect to Effexor XR. Each of the plaintiffs seeks treble damages (for itself in the individual actions or on behalf of the putative class in the purported class actions) for alleged price overcharges for Effexor XR or generic Effexor XR in the U.S. and its territories since June 14, 2008. All of these actions have been consolidated in the U.S. District Court for the District of New Jersey.
In October 2014, the District Court dismissed the direct purchaser plaintiffs’ claims based on the litigation settlement agreement, but declined to dismiss the other direct purchaser plaintiff claims. In January 2015, the District Court entered partial final judgments as to all settlement agreement claims, including those asserted by direct purchasers and end-payer plaintiffs, which plaintiffs have appealed to the United States Court of Appeals for the Third Circuit. Motions to dismiss remain pending as to the end-payer plaintiffs' remaining claims.
Zoloft
A number of individual lawsuits and multi-plaintiff lawsuits have been filed against us and/or our subsidiaries in various federal and state courts alleging personal injury as a result of the purported ingestion of Zoloft. Among other types of actions, the Zoloft personal injury litigation includes actions alleging a variety of birth defects as a result of the purported ingestion of Zoloft by women during pregnancy. Plaintiffs in these birth-defect actions seek compensatory and punitive damages and the disgorgement of profits resulting from the sale of Zoloft. In April 2012, the federal birth-defect cases were transferred for consolidated pre-trial proceedings to a Multi-District Litigation (In re Zoloft Products Liability Litigation MDL-2342) in the U.S. District Court for the Eastern District of Pennsylvania.
Neurontin
A number of lawsuits, including purported class actions, have been filed against us in various federal and state courts alleging claims arising from the promotion and sale of Neurontin. The plaintiffs in the purported class actions seek to represent nationwide and certain statewide classes consisting of persons, including individuals, health insurers, employee benefit plans and other third-party payers, who purchased or reimbursed patients for the purchase of Neurontin that allegedly was used for indications other than those included in the product labeling approved by the FDA. In 2004, many of the suits pending in federal courts, including individual actions as well as purported class actions, were transferred for consolidated pre-trial proceedings to a Multi-District Litigation (In re Neurontin Marketing, Sales Practices and Product Liability Litigation MDL-1629) in the U.S. District Court for the District of Massachusetts.
In the Multi-District Litigation, the District Court (i) denied the plaintiffs’ motion for certification of a nationwide class of all individual consumers and third-party payers who allegedly purchased or reimbursed patients for the purchase of Neurontin for off-label uses from 1994 through 2004, and (ii) dismissed actions by certain proposed class representatives for third-party payers and for individual consumers. In April 2013, the U.S. Court of Appeals for the First Circuit reversed the decision of the District Court dismissing the action by the third-party payer proposed class representatives and remanded that action to the District Court for further consideration, including reconsideration of class certification.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In December 2013, the U.S. Supreme Court denied our petition for certiorari seeking review of the First Circuit's decision reversing the dismissal of the third-party payer purported class action. In April 2014, we and the attorneys for the proposed class representatives and for the plaintiffs in various individual actions entered into an agreement-in-principle to settle the third-party payer purported class action, subject to court approval, as well as the pending individual actions by third-party payers, for an aggregate of $325 million. In November 2014, the District Court granted final approval of the settlement. Plaintiffs’ counsel have agreed to dismiss with prejudice all Neurontin marketing lawsuits by consumers, and have dismissed the purported statewide consumer class actions in California and Illinois. Some counsel have advised that certain plaintiffs can no longer be located. We expect the Neurontin marketing lawsuits by consumers to be resolved without a material impact on Pfizer.
Lipitor
In 2004, a former employee filed a “whistleblower” action against us in the U.S. District Court for the Eastern District of New York. The complaint remained under seal until September 2007, at which time the U.S. Attorney for the Eastern District of New York declined to intervene in the case. We were served with the complaint in December 2007. Plaintiff alleges off-label promotion of Lipitor in violation of the Federal Civil False Claims Act and the false claims acts of certain states, and he seeks treble damages and civil penalties on behalf of the federal government and the specified states as the result of their purchase, or reimbursement of patients for the purchase, of Lipitor allegedly for such off-label uses. Plaintiff also seeks compensation as a whistleblower under those federal and state statutes. In addition, plaintiff alleges that he was wrongfully terminated, in violation of the anti-retaliation provisions of applicable federal and New York law, and he seeks damages and the reinstatement of his employment. In 2009, the District Court dismissed without prejudice the off-label promotion claims and, in 2010, plaintiff filed an amended complaint containing off-label promotion allegations that are substantially similar to the allegations in the original complaint. In November 2012, the District Court dismissed the amended complaint. In December 2012, plaintiff appealed the District Court's decision to the U.S. Court of Appeals for the Second Circuit. In August 2014, the U.S. Court of Appeals for the Second Circuit dismissed the appeal for lack of jurisdiction, and sent the case back to the District Court for clarification of its ruling regarding the plaintiff's employment claims. In November 2014, the District Court granted plaintiff’s motion for a partial final judgment certifying the dismissal of the false claims counts, and plaintiff appealed the order dismissing those claims to the U.S. Court of Appeals for the Second Circuit.
Beginning in November 2011, purported class actions relating to Lipitor were filed in various federal courts against, among others, Pfizer, certain affiliates of Pfizer, and, in most of the actions, Ranbaxy, Inc. (Ranbaxy) and certain affiliates of Ranbaxy. The plaintiffs in these various actions seek to represent nationwide, multi-state or statewide classes consisting of persons or entities who directly purchased, indirectly purchased or reimbursed patients for the purchase of Lipitor (or, in certain of the actions, generic Lipitor) from any of the defendants from March 2010 until the cessation of the defendants’ allegedly unlawful conduct (the Class Period). The plaintiffs allege delay in the launch of generic Lipitor, in violation of federal antitrust laws and/or state antitrust, consumer protection and various other laws, resulting from (i) the 2008 agreement pursuant to which Pfizer and Ranbaxy settled certain patent litigation involving Lipitor, and Pfizer granted Ranbaxy a license to sell a generic version of Lipitor in various markets beginning on varying dates, and (ii) in certain of the actions, the procurement and/or enforcement of certain patents for Lipitor. Each of the actions seeks, among other things, treble damages on behalf of the putative class for alleged price overcharges for Lipitor (or, in certain of the actions, generic Lipitor) during the Class Period. In addition, individual actions have been filed against Pfizer, Ranbaxy and certain of their affiliates, among others, that assert claims and seek relief for the plaintiffs that are substantially similar to the claims asserted and the relief sought in the purported class actions described above. These various actions have been consolidated for pre-trial proceedings in a Multi-District Litigation (In re Lipitor Antitrust Litigation MDL-2332) in the U.S. District Court for the District of New Jersey.
In September 2013 and 2014, the District Court dismissed with prejudice the claims by direct purchasers. In October and November 2014, the District Court dismissed with prejudice the claims of all other MDL plaintiffs. All plaintiffs have appealed the District Court’s orders dismissing their claims with prejudice to the United States Court of Appeals for the Third Circuit. In addition, the direct purchaser class plaintiffs appealed the order denying their motion to amend the judgment and for leave to amend their complaint to the United States Court of Appeals for the Third Circuit.
Also, in January 2013, the State of West Virginia filed an action in West Virginia state court against Pfizer and Ranbaxy, among others, that asserts claims and seeks relief on behalf of the State of West Virginia and residents of that state that are substantially similar to the claims asserted and the relief sought in the purported class actions described above.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
A number of individual and multi-plaintiff lawsuits have been filed against us in various federal and state courts alleging that the plaintiffs developed type 2 diabetes as a result of the purported ingestion of Lipitor. Plaintiffs seek compensatory and punitive damages. In February 2014, the federal actions were transferred for consolidated pre-trial proceedings to a Multi-District Litigation (In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation (No. II) MDL-2502) in the U.S. District Court for the District of South Carolina.
Chantix/Champix
Beginning in December 2008, purported class actions were filed against us in the Ontario Superior Court of Justice (Toronto Region), the Superior Court of Quebec (District of Montreal), the Court of Queen’s Bench of Alberta, Judicial District of Calgary, and the Superior Court of British Columbia (Vancouver Registry) on behalf of all individuals and third-party payers in Canada who have purchased and ingested Champix or reimbursed patients for the purchase of Champix. Each of these actions asserts claims under Canadian product liability law, including with respect to the safety and efficacy of Champix, and, on behalf of the putative class, seeks monetary relief, including punitive damages. In June 2012, the Ontario Superior Court of Justice certified the Ontario proceeding as a class action, defining the class as consisting of the following: (i) all persons in Canada who ingested Champix during the period from April 2, 2007 to May 31, 2010 and who experienced at least one of a number of specified neuropsychiatric adverse events; (ii) all persons who are entitled to assert claims in respect of Champix pursuant to Canadian legislation as the result of their relationship with a class member; and (iii) all health insurers who are entitled to assert claims in respect of Champix pursuant to Canadian legislation. The Ontario Superior Court of Justice certified the class against Pfizer Canada Inc. only and ruled that the action against Pfizer should be stayed until after the trial of the issues that are common to the class members. The actions in Quebec, Alberta and British Columbia have been stayed in favor of the Ontario action, which is proceeding on a national basis.
Celebrex
Beginning in July 2014, purported class actions were filed in the United States District Court for the Eastern District of Virginia against Pfizer and certain subsidiaries of Pfizer relating to Celebrex. The plaintiffs seek to represent U.S. nationwide or multi-state classes consisting of persons or entities who directly purchased from the defendants, or indirectly purchased or reimbursed patients for some or all of the purchase price of, Celebrex or generic Celebrex from May 31, 2014 until the cessation of the defendants’ allegedly unlawful conduct. The plaintiffs allege delay in the launch of generic Celebrex in violation of federal antitrust laws or certain state antitrust, consumer protection and various other laws as a result of Pfizer fraudulently obtaining and improperly listing a patent on Celebrex, engaging in sham litigation, and prolonging the impact of sham litigation through settlement activity that further delayed generic entry. Each of the actions seeks treble damages on behalf of the putative class for alleged price overcharges for Celebrex since May 31, 2014. In December 2014, the District Court granted the parties’ joint motions to consolidate the direct purchaser and end-payor cases, and all such cases were consolidated as of March 2015. In October 2014 and March 2015, we filed motions to dismiss the direct purchasers’ and end-payors’ amended complaints, respectively.
Reglan
Reglan is a pro-motility medicine for the treatment of gastroesophageal reflux disease and diabetic gastroparesis that was marketed by Wyeth and a predecessor company from 1979 until the end of 2001, when Wyeth sold the product and transferred the new drug application to another pharmaceutical company. Generic versions of Reglan have been sold by other companies since 1985. Pfizer, as Wyeth’s parent company, and certain wholly owned subsidiaries and limited liability companies, including Wyeth, along with several other pharmaceutical manufacturers, have been named as defendants in numerous actions in various federal and state courts alleging personal injury resulting from the use of Reglan and/or generic equivalents thereof. Plaintiffs in these actions seek to hold the defendants, including Pfizer and its affiliated companies, liable for a variety of personal injuries, including movement disorders such as Tardive Dyskinesia, allegedly resulting from the ingestion of Wyeth’s product and/or products sold by other companies. A substantial majority of the claims involve the ingestion of generic versions of Reglan produced and sold by other companies. Claims against Pfizer and its affiliated companies are largely based on the novel theory of innovator liability under which plaintiffs allege that an innovator pharmaceutical company can be liable for injuries caused by the ingestion of generic forms of the product produced and sold by other companies. This theory of liability has been rejected by more than 100 federal and state courts, applying the laws of 30 states. However, a small number of courts have adopted the theory, including the Alabama Supreme Court in August 2014. In May 2015, the Governor of Alabama signed legislation that abolishes the innovator liability theory in Alabama for any cases filed on or after November 1, 2015. Actions have been filed under the laws of multiple jurisdictions, including Alabama, and additional actions may be filed in the future.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
A3. Legal Proceedings––Commercial and Other Matters
Average Wholesale Price Litigation
Pfizer, certain of its subsidiaries and other pharmaceutical manufacturers were sued in various state courts by a number of states alleging that the defendants provided average wholesale price (AWP) information for certain of their products that was higher than the actual average prices at which those products were sold. The AWP is used to determine reimbursement levels under Medicare Part B and Medicaid and in many private-sector insurance policies and medical plans. All but two of those actions have been resolved through settlement, dismissal or final judgment. The plaintiff states in the two remaining actions claim that the alleged spread between the AWPs at which purchasers were reimbursed and the actual sale prices was promoted by the defendants as an incentive to purchase certain of their products. In addition to suing on their own behalf, the two states seek to recover on behalf of individuals, private-sector insurance companies and medical plans in their states. These actions allege, among other things, fraud, unfair competition, unfair trade practices and the violation of consumer protection statutes, and seek monetary and other relief, including civil penalties and treble damages.
Monsanto-Related Matters
In 1997, Monsanto Company (Former Monsanto) contributed certain chemical manufacturing operations and facilities to a newly formed corporation, Solutia Inc. (Solutia), and spun off the shares of Solutia. In 2000, Former Monsanto merged with Pharmacia & Upjohn Company to form Pharmacia Corporation (Pharmacia). Pharmacia then transferred its agricultural operations to a newly created subsidiary, named Monsanto Company (New Monsanto), which it spun off in a two-stage process that was completed in 2002. Pharmacia was acquired by Pfizer in 2003 and is now a wholly owned subsidiary of Pfizer.
In connection with its spin-off that was completed in 2002, New Monsanto assumed, and agreed to indemnify Pharmacia for, any liabilities related to Pharmacia’s former agricultural business. New Monsanto is defending and indemnifying Pharmacia in connection with various claims and litigation arising out of, or related to, the agricultural business.
In connection with its spin-off in 1997, Solutia assumed, and agreed to indemnify Pharmacia for, liabilities related to Former Monsanto's chemical businesses. As the result of its reorganization under Chapter 11 of the U.S. Bankruptcy Code, Solutia’s indemnification obligations relating to Former Monsanto’s chemical businesses are limited to sites that Solutia has owned or operated. In addition, in connection with its spinoff that was completed in 2002, New Monsanto assumed, and agreed to indemnify Pharmacia for, any liabilities primarily related to Former Monsanto's chemical businesses, including, but not limited to, any such liabilities that Solutia assumed. Solutia's and New Monsanto's assumption of, and agreement to, indemnify Pharmacia for these liabilities apply to pending actions and any future actions related to Former Monsanto's chemical businesses in which Pharmacia is named as a defendant, including, without limitation, actions asserting environmental claims, including alleged exposure to polychlorinated biphenyls. Solutia and New Monsanto are defending and indemnifying Pharmacia in connection with various claims and litigation arising out of, or related to, Former Monsanto’s chemical businesses.
Environmental Matters
In 2009, we submitted to the U.S. Environmental Protection Agency (EPA) a corrective measures study report with regard to Pharmacia Corporation's discontinued industrial chemical facility in North Haven, Connecticut and a revised site-wide feasibility study with regard to Wyeth Holdings Corporation's discontinued industrial chemical facility in Bound Brook, New Jersey. In September 2010, our corrective measures study report with regard to the North Haven facility was approved by the EPA, and we commenced construction of the site remedy in late 2011 under an Updated Administrative Order on Consent with the EPA. In July 2011, Wyeth Holdings Corporation finalized an Administrative Settlement Agreement and Order on Consent for Removal Action with the EPA with regard to the Bound Brook facility. In May 2012, we completed construction of an interim remedy to address the discharge of impacted groundwater from that facility to the Raritan River. In September 2012, the EPA issued a final remediation plan for the Bound Brook facility's main plant area, which is generally in accordance with one of the remedies evaluated in our revised site-wide feasibility study. In March 2013, Wyeth Holdings Corporation entered into an Administrative Settlement Agreement and Order on Consent with the EPA to allow us to undertake detailed engineering design of the remedy for the main plant area and to perform a focused feasibility study for two adjacent lagoons. The estimated costs of the site remedy for the North Haven facility and the site remediation for the Bound Brook facility are covered by accruals previously taken by us.
We are a party to a number of other proceedings brought under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended, and other state, local or foreign laws in which the primary relief sought is the cost of past and/or future remediation.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
A4. Legal Proceedings––Government Investigations
Like other pharmaceutical companies, we are subject to investigations and extensive regulation by government agencies in the U.S., other developed markets, and multiple emerging markets in which we operate. As a result, we have interactions with government agencies on an ongoing basis. Criminal charges, and substantial fines and/or civil penalties, as well as limitations on our ability to conduct business in applicable jurisdictions, could result from government investigations. Among the investigations by government agencies is the matter discussed below.
In 2009, the U.S. Department of Justice (DOJ) filed a civil complaint in intervention in two qui tam actions that had been filed under seal in the U.S. District Court for the District of Massachusetts. The complaint alleges that Wyeth’s practices relating to the pricing for Protonix for Medicaid rebate purposes between 2001 and 2006, prior to Wyeth's acquisition by Pfizer, violated the Federal Civil False Claims Act and federal common law. The two qui tam actions have been unsealed and the complaints include substantially similar allegations. In addition, in 2009, several states and the District of Columbia filed a complaint under the same docket number asserting violations of various state laws based on allegations substantially similar to those set forth in the civil complaint filed by the DOJ.
A5. Legal Proceedings––Matter Resolved During the First Three Months of 2015
As previously reported, during the first three months of 2015, the matter discussed below was resolved.
Lyrica (pregabalin)
In May and June 2011, Apotex Inc. notified us that it had filed abbreviated new drug applications with the FDA seeking approval to market generic versions of Lyrica oral solution and Lyrica capsules, respectively. Apotex Inc. asserts the invalidity and non-infringement of the basic patent, as well as the seizure patent that expired in October 2013. In July 2011, we filed an action against Apotex Inc. in the U.S. District Court for the District of Delaware asserting the validity and infringement of the challenged patents in connection with both abbreviated new drug applications. In January 2015, the District Court entered a stipulated dismissal, and as a result, Apotex Inc. cannot obtain FDA approval for, or market in the U.S., its generic versions of Lyrica prior to the expiration of the basic patent in December 2018.