e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2011
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____ to _____
Commission File No. 1-6571
Merck & Co., Inc.
One Merck Drive
Whitehouse Station, N.J. 08889-0100
(908) 423-1000
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Incorporated in New Jersey
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I.R.S. Employer
Identification No. 22-1918501 |
The number of shares of common stock outstanding as of the close of business on April 29, 2011:
3,086,584,896
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. Yes þ No o
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). Yes
þ No o
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 the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
(Do not check if a smaller reporting company)
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
TABLE OF CONTENTS
Part I Financial Information
Item 1. Financial Statements
MERCK & CO., INC. AND SUBSIDIARIES
INTERIM CONSOLIDATED STATEMENT OF INCOME
(Unaudited, $ in millions except per share amounts)
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Three Months Ended |
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March 31, |
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2011 |
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2010 |
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Sales |
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$ |
11,580 |
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$ |
11,422 |
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Costs, Expenses and Other |
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Materials and production |
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4,059 |
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5,216 |
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Marketing and administrative |
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3,164 |
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3,222 |
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Research and development |
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2,158 |
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2,051 |
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Restructuring costs |
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(14 |
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288 |
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Equity income from affiliates |
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(138 |
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(138 |
) |
Other (income) expense, net |
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622 |
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167 |
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9,851 |
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10,806 |
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Income Before Taxes |
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1,729 |
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616 |
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Taxes on Income |
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658 |
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286 |
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Net Income |
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$ |
1,071 |
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$ |
330 |
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Less: Net Income Attributable to Noncontrolling Interests |
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28 |
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31 |
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Net Income Attributable to Merck & Co., Inc. |
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$ |
1,043 |
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$ |
299 |
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Basic Earnings per Common Share Attributable to
Merck & Co., Inc. Common Shareholders |
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$ |
0.34 |
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$ |
0.10 |
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Earnings per Common Share Assuming Dilution Attributable
to Merck & Co., Inc. Common Shareholders |
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$ |
0.34 |
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$ |
0.09 |
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Dividends Declared per Common Share |
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$ |
0.38 |
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$ |
0.38 |
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The accompanying notes are an integral part of this consolidated financial statement.
- 2 -
MERCK & CO., INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEET
(Unaudited, $ in millions except per share amounts)
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March 31, |
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December 31, |
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2011 |
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2010 |
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Assets |
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Current Assets |
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Cash and cash equivalents |
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$ |
11,695 |
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$ |
10,900 |
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Short-term investments |
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1,334 |
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1,301 |
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Accounts receivable (net of allowance for doubtful accounts of $111
in 2011 and $104 in 2010) |
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7,955 |
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7,344 |
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Inventories (excludes inventories of $1,264 in 2011 and $1,194
in 2010 classified in Other assets see Note 6) |
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6,057 |
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5,868 |
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Deferred income taxes and other current assets |
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3,983 |
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3,651 |
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Total current assets |
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31,024 |
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29,064 |
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Investments |
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2,084 |
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2,175 |
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Property, Plant and Equipment, at cost, net of depreciation
of $14,515 in 2011 and $13,481 in 2010 |
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16,833 |
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17,082 |
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Goodwill |
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12,207 |
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12,378 |
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Other Intangibles, Net |
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37,906 |
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39,456 |
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Other Assets |
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5,811 |
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5,626 |
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$ |
105,865 |
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$ |
105,781 |
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Liabilities and Equity |
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Current Liabilities |
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Loans payable and current portion of long-term debt |
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$ |
2,202 |
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$ |
2,400 |
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Trade accounts payable |
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2,402 |
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2,308 |
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Accrued and other current liabilities |
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8,555 |
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8,514 |
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Income taxes payable |
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1,326 |
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1,243 |
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Dividends payable |
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1,177 |
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1,176 |
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Total current liabilities |
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15,662 |
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15,641 |
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Long-Term Debt |
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15,644 |
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15,482 |
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Deferred Income Taxes and Noncurrent Liabilities |
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17,720 |
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17,853 |
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Merck & Co., Inc. Stockholders Equity |
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Common stock, $0.50 par value
Authorized - 6,500,000,000 shares
Issued - 3,576,948,356 shares in 2011 and 2010 |
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1,788 |
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1,788 |
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Other paid-in capital |
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40,690 |
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40,701 |
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Retained earnings |
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37,400 |
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37,536 |
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Accumulated other comprehensive loss |
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(3,170 |
) |
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(3,216 |
) |
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76,708 |
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76,809 |
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Less treasury stock, at cost
491,657,062 shares in 2011 and 494,841,533 shares in 2010 |
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22,324 |
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22,433 |
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Total Merck & Co., Inc. stockholders equity |
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54,384 |
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54,376 |
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Noncontrolling Interests |
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2,455 |
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2,429 |
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Total equity |
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56,839 |
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56,805 |
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$ |
105,865 |
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$ |
105,781 |
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The accompanying notes are an integral part of this consolidated financial statement.
- 3 -
MERCK & CO., INC. AND SUBSIDIARIES
INTERIM CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited, $ in millions)
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Three Months Ended |
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March 31, |
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2011 |
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2010 |
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Cash Flows from Operating Activities |
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Net income |
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$ |
1,071 |
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$ |
330 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
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1,831 |
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1,687 |
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In-process research and development impairment charges |
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302 |
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27 |
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Equity income from affiliates |
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(138 |
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(138 |
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Dividends and distributions from equity affiliates |
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65 |
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77 |
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Deferred income taxes |
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(214 |
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152 |
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Share-based compensation |
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93 |
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132 |
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Other |
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(222 |
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161 |
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Net changes in assets and liabilities |
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(1,067 |
) |
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(1,062 |
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Net Cash Provided by Operating Activities |
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1,721 |
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1,366 |
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Cash Flows from Investing Activities |
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Capital expenditures |
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(324 |
) |
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(343 |
) |
Purchases of securities and other investments |
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(1,382 |
) |
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(2,933 |
) |
Proceeds from sales of securities and other investments |
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1,524 |
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273 |
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Dispositions of businesses, net of cash divested |
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306 |
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Acquisitions of businesses, net of cash acquired |
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(131 |
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(Increase) decrease in restricted assets |
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(25 |
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Other |
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(19 |
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11 |
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Net Cash Provided by (Used in) Investing Activities |
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105 |
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(3,148 |
) |
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Cash Flows from Financing Activities |
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Net change in short-term borrowings |
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(197 |
) |
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2,620 |
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Payments on debt |
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(4 |
) |
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(622 |
) |
Dividends paid to stockholders |
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(1,175 |
) |
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(1,189 |
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Proceeds from exercise of stock options |
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37 |
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195 |
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Other |
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167 |
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(62 |
) |
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Net Cash (Used in) Provided by Financing Activities |
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(1,172 |
) |
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942 |
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Effect of Exchange Rate Changes on Cash and Cash Equivalents |
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141 |
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(235 |
) |
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Net Increase (Decrease) in Cash and Cash Equivalents |
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795 |
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(1,075 |
) |
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Cash and Cash Equivalents at Beginning of Year |
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10,900 |
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9,311 |
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Cash and Cash Equivalents at End of Period |
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$ |
11,695 |
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$ |
8,236 |
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The accompanying notes are an integral part of this consolidated financial statement.
- 4 -
Notes to Consolidated Financial Statements (unaudited)
1. Basis of Presentation
The accompanying unaudited interim consolidated financial statements have been prepared
pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information
and disclosures required by accounting principles generally accepted in the United States for
complete consolidated financial statements are not included herein. The interim statements should
be read in conjunction with the audited financial statements and notes thereto included in Merck &
Co., Inc.s Form 10-K filed on February 28, 2011.
On November 3, 2009, Merck & Co., Inc. (Old Merck) and Schering-Plough Corporation
(Schering-Plough) completed their previously-announced merger (the Merger). In the Merger,
Schering-Plough acquired all of the shares of Old Merck, which became a wholly-owned subsidiary of
Schering-Plough and was renamed Merck Sharp & Dohme Corp. Schering-Plough continued as the
surviving public company and was renamed Merck & Co., Inc. (New Merck or the Company).
However, for accounting purposes only, the Merger was treated as an acquisition with Old Merck
considered the accounting acquirer. Accordingly, the accompanying financial statements reflect Old
Mercks stand-alone operations as they existed prior to the completion of the Merger. References in these financial statements to
Merck for periods prior to the Merger refer to Old Merck and for periods after the completion of
the Merger to New Merck.
The results of operations of any interim period are not necessarily indicative of the results
of operations for the full year. In the Companys opinion, all adjustments necessary for a fair
presentation of these interim statements have been included and are of a normal and recurring
nature.
Certain reclassifications have been made to prior year amounts to conform to the current year
presentation.
Recently Adopted Accounting Standards
In October 2009, the Financial Accounting Standards Board issued new guidance for revenue
recognition with multiple deliverables. The Company adopted this
guidance prospectively for revenue arrangements
entered into or materially modified on or after January 1, 2011. This guidance eliminates the
residual method under the current guidance and replaces it with the relative selling price method
when allocating revenue in a multiple deliverable arrangement. The selling price for each
deliverable shall be determined using vendor specific objective evidence of selling price, if it
exists, otherwise third-party evidence of selling price shall be used. If neither exists for a
deliverable, the vendor shall use its best estimate of the selling price for that deliverable. The
effect of adoption on the Companys financial position and results of operations was not material.
2. Restructuring
Merger Restructuring Program
In February 2010, the Company commenced actions under a global restructuring program (the
Merger Restructuring Program) in conjunction with the integration of the legacy Merck and legacy
Schering-Plough businesses. This Merger Restructuring Program is intended to optimize the cost
structure of the combined company. Additional actions under the program continued during 2010. As
part of the restructuring actions taken thus far under the Merger Restructuring Program, the
Company expects to reduce its total workforce measured at the time of the Merger by approximately
17% across the Company worldwide. In addition, the Company has eliminated over 2,500 positions
which were vacant at the time of the Merger. These workforce reductions will primarily come from
the elimination of duplicative positions in sales, administrative and headquarters organizations,
as well as from the sale or closure of certain manufacturing and research and development sites and
the consolidation of office facilities. During this period, the Company will continue to hire new
employees in strategic growth areas of the business as necessary. The Company will continue to pursue productivity efficiencies and
evaluate its manufacturing supply chain capabilities on an ongoing basis which may result in future
restructuring actions.
In connection with the Merger Restructuring Program, separation costs under the Companys
existing severance programs worldwide were recorded in the fourth quarter of 2009 to the extent
such costs were probable and reasonably estimable. The Company commenced accruing costs related to
enhanced termination benefits offered to employees under the Merger Restructuring Program in the
first quarter of 2010 when the necessary criteria were met. The Company recorded total pretax
restructuring costs of $112 million and $283 million in the first quarter of 2011 and 2010,
respectively, related to this program. Since inception of the Merger Restructuring Program through
March 31, 2011, Merck has recorded total pretax accumulated costs of approximately $3.4 billion and
eliminated approximately 12,300 positions comprised of employee separations, and the elimination of
contractors and vacant positions. The restructuring actions taken thus far under the Merger
Restructuring Program are expected to be substantially completed by the end of 2012, with the
exception of certain manufacturing facilities actions, with the total cumulative pretax costs
estimated to be approximately $3.8 billion to $4.6 billion. The Company estimates that
approximately two-thirds of the cumulative
- 5 -
Notes to Consolidated Financial Statements (unaudited) (continued)
pretax costs relate to cash outlays, primarily related to employee separation expense.
Approximately one-third of the cumulative pretax costs are non-cash, relating primarily to the
accelerated depreciation of facilities to be closed or divested.
2008 Global Restructuring Program
In October 2008, Old Merck announced a global restructuring program (the 2008 Restructuring
Program) to reduce its cost structure, increase efficiency, and enhance competitiveness. As part
of the 2008 Restructuring Program, the Company expects to eliminate approximately 7,200 positions
6,800 active employees and 400 vacancies across the Company worldwide by the end of 2011.
Pretax restructuring costs of $4 million and $65 million were recorded in the first quarter of 2011
and 2010, respectively, related to the 2008 Restructuring Program. Since inception of the 2008
Restructuring Program through March 31, 2011, Merck has recorded total pretax accumulated costs of
$1.6 billion and eliminated approximately 5,920 positions comprised of employee separations and the
elimination of contractors and vacant positions. The 2008 Restructuring Program is expected to be
completed by the end of 2011 with the total cumulative pretax costs estimated to be $1.6 billion to
$2.0 billion. The Company estimates that two-thirds of the cumulative pretax costs relate to cash
outlays, primarily from employee separation expense. Approximately one-third of the cumulative
pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be
closed or divested.
For segment reporting, restructuring charges are unallocated expenses.
The following tables summarize the charges related to Merger Restructuring Program and 2008
Restructuring Program activities by type of cost:
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Three Months Ended March 31, 2011 |
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Separation |
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Accelerated |
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($ in millions) |
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Costs |
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Depreciation |
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Other |
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Total |
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Merger Restructuring Program |
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Materials and production |
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$ |
|
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$ |
60 |
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$ |
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$ |
60 |
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Marketing and administrative |
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23 |
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23 |
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Research and development |
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42 |
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3 |
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45 |
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Restructuring costs |
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(37 |
) |
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21 |
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(16 |
) |
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(37 |
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|
125 |
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24 |
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|
112 |
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2008 Restructuring Program |
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Materials and production |
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3 |
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(1 |
) |
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2 |
|
Restructuring costs |
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(1 |
) |
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3 |
|
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2 |
|
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|
(1 |
) |
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3 |
|
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|
2 |
|
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|
4 |
|
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$ |
(38 |
) |
|
$ |
128 |
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$ |
26 |
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|
$ |
116 |
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|
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|
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Three Months Ended March 31, 2010 |
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Separation |
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Accelerated |
|
|
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($ in millions) |
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Costs |
|
Depreciation |
|
Other |
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Total |
|
Merger Restructuring Program |
|
|
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|
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|
|
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Materials and production
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|
$ |
|
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|
$ |
25 |
|
|
$ |
|
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|
$ |
25 |
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Research and development
|
|
|
|
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6 |
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|
6 |
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Restructuring costs
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|
|
209 |
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|
43 |
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|
|
252 |
|
|
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|
|
209 |
|
|
|
25 |
|
|
|
49 |
|
|
|
283 |
|
|
|
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|
|
2008 Restructuring Program |
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Materials and production
|
|
|
|
|
|
|
29 |
|
|
|
|
|
|
|
29 |
|
Restructuring costs
|
|
|
19 |
|
|
|
|
|
|
|
17 |
|
|
|
36 |
|
|
|
|
|
19 |
|
|
|
29 |
|
|
|
17 |
|
|
|
65 |
|
|
|
|
$ |
228 |
|
|
$ |
54 |
|
|
$ |
66 |
|
|
$ |
348 |
|
|
Separation costs are associated with actual headcount reductions, as well as those
headcount reductions which were probable and could be reasonably estimated. In the first quarter
of 2011, separation costs for the Merger Restructuring Program include a
reduction of separation reserves of approximately $50 million resulting from the Companys
decision in the first quarter to retain approximately 380 employees at its Oss, Netherlands
research facility that had previously been expected to be separated. In the first quarter of 2011
and 2010, approximately 750 positions and 5,150 positions, respectively, were eliminated under the
Merger Restructuring Program and approximately 120 positions and 535 positions, respectively, were
eliminated under the 2008 Restructuring
- 6 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Program. These position eliminations were comprised of
actual headcount reductions and the elimination of contractors and vacant positions.
Accelerated depreciation costs primarily relate to manufacturing, research and administrative
facilities and equipment to be sold or closed as part of the programs. Accelerated depreciation
costs represent the difference between the depreciation expense to be recognized over the revised
useful life of the site, based upon the anticipated date the site will be closed or divested, and
depreciation expense as determined utilizing the useful life prior to the restructuring actions.
All of the sites have and will continue to operate up through the respective closure dates, and
since future cash flows were sufficient to recover the respective book values, Merck was required
to accelerate depreciation of the site assets rather than write them off immediately.
Other activity in the first quarter of 2011 and 2010 includes asset abandonment, shut-down and
other related costs. Additionally, other activity includes employee-related costs such as
curtailment, settlement and termination charges associated with pension and other postretirement
benefit plans (see Note 12) and share-based compensation costs.
The following table summarizes the charges and spending relating to Merger Restructuring
Program and 2008 Restructuring Program activities for the three months ended March 31, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Separation |
|
|
Accelerated |
|
|
|
|
|
|
|
($ in millions) |
|
Costs |
|
|
Depreciation |
|
|
Other |
|
|
Total |
|
|
Merger Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring reserves January 1, 2011 |
|
$ |
859 |
|
|
$ |
|
|
|
$ |
64 |
|
|
$ |
923 |
|
Expense |
|
|
(37 |
) |
|
|
125 |
|
|
|
24 |
|
|
|
112 |
|
(Payments) receipts, net |
|
|
(159 |
) |
|
|
|
|
|
|
(9 |
) |
|
|
(168 |
) |
Non-cash activity |
|
|
|
|
|
|
(125 |
) |
|
|
(24 |
) |
|
|
(149 |
) |
|
Restructuring reserves March 31, 2011 (1) |
|
$ |
663 |
|
|
$ |
|
|
|
$ |
55 |
|
|
$ |
718 |
|
|
2008 Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring reserves January 1, 2011 |
|
$ |
196 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
196 |
|
Expense |
|
|
(1 |
) |
|
|
3 |
|
|
|
2 |
|
|
|
4 |
|
(Payments) receipts, net |
|
|
(9 |
) |
|
|
|
|
|
|
(2 |
) |
|
|
(11 |
) |
Non-cash activity |
|
|
|
|
|
|
(3 |
) |
|
|
|
|
|
|
(3 |
) |
|
Restructuring reserves March 31, 2011 (1) |
|
$ |
186 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
186 |
|
|
|
|
|
(1) |
|
The cash outlays associated with the Merger Restructuring Program are expected
to be substantially completed by the end of 2012. The cash outlays associated with the
remaining restructuring reserve for the 2008 Restructuring Program are expected to be
completed by the end of 2011. |
Legacy Schering-Plough Program
Prior to the Merger, Schering-Plough commenced a Productivity Transformation Program which was
designed to reduce and avoid costs and increase productivity. The Company recorded accelerated
depreciation costs included Material and production of $10 million and $3 million for the first
quarter of 2011 and 2010, respectively. The remaining reserve associated with this program was $47
million at March 31, 2011.
3. Acquisitions, Divestitures, Research Collaborations and License Agreements
In April 2011, Merck entered into a definitive agreement under which Merck will acquire
Inspire Pharmaceuticals, Inc. (Inspire), a specialty pharmaceutical company focused on developing
and commercializing ophthalmic products. Under the terms of the agreement, Merck commenced a
tender offer for all outstanding common stock of Inspire at a price of $5.00 per share in cash.
The transaction has a total cash value of approximately $430 million. The transaction has been
unanimously approved by the boards of directors of both companies and Inspires board recommended
that the companys shareholders tender their shares pursuant to the tender offer. In addition,
Warburg Pincus Private Equity IX, L.P., which owns approximately 28% of the outstanding shares of
Inspire, has agreed to tender all of its shares into the offer. The closing of the tender offer
will be subject to certain conditions, including the tender of a number of Inspire shares that,
together with shares owned by Merck, represent at least a majority of the total number of Inspires
outstanding shares (assuming the exercise of all options and vesting of restricted stock units),
and customary closing conditions. Upon the completion of the tender offer, Merck will acquire all
remaining shares of Inspire through a second-step merger. The Company anticipates the transaction will close
in the second quarter of 2011.
In March 2011, the Company sold the Merck BioManufacturing Network, a leading provider of
contract manufacturing and development services for the biopharmaceutical industry and wholly owned
by Merck, to Fujifilm Corporation (Fujifilm). Under
- 7 -
Notes to Consolidated Financial Statements (unaudited) (continued)
the terms of the agreement, Fujifilm will
purchase all of the equity interests in two Merck subsidiaries which together own all assets of the
Merck BioManufacturing Network comprising facilities located in Research Triangle Park, North
Carolina and Billingham, U.K.; and including manufacturing contracts; business support operations
and a highly skilled workforce. As part of the agreement with Fujifilm, Merck has committed to
certain continued development and manufacturing activities with these two companies. The
transaction resulted in a gain of $134 million in the first
quarter of 2011 reflected in Other (income) expense, net.
4. Collaborative Arrangements
The Company continues its strategy of establishing external alliances to complement its
substantial internal research capabilities, including research collaborations, licensing
preclinical and clinical compounds and technology platforms to drive both near- and long-term
growth. The Company supplements its internal research with a licensing and external alliance
strategy focused on the entire spectrum of collaborations from early research to late-stage
compounds, as well as new technologies across a broad range of therapeutic areas. These
arrangements often include upfront payments and royalty or profit share payments, contingent upon
the occurrence of certain future events linked to the success of the asset in development, as well
as expense reimbursements or payments to the third party.
Cozaar/Hyzaar
In 1989, Old Merck and E.I. duPont de Nemours and Company (DuPont) agreed to form a
long-term research and marketing collaboration to develop a class of therapeutic agents for high
blood pressure and heart disease, discovered by DuPont, called angiotensin II receptor antagonists,
which include Cozaar and Hyzaar. In return, Old Merck provided DuPont marketing rights in the
United States and Canada to its prescription medicines, Sinemet and Sinemet CR (the Company has
since regained global marketing rights to Sinemet and Sinemet CR). Pursuant to a 1994 agreement
with DuPont, the Company has an exclusive licensing agreement to market Cozaar and Hyzaar, which
are both registered trademarks of DuPont, in return for royalties and profit share payments to
DuPont. The patents that provided market exclusivity in the United States for Cozaar and Hyzaar
expired in April 2010. In addition, Cozaar and Hyzaar lost patent protection in a number of major
European markets in March 2010.
Remicade/Simponi
In 1998, a subsidiary of Schering-Plough entered into a licensing agreement with Centocor
Ortho Biotech Inc. (Centocor), a Johnson & Johnson company, to market Remicade, which is
prescribed for the treatment of inflammatory diseases. In 2005, Schering-Ploughs subsidiary
exercised an option under its contract with Centocor for license rights to develop and
commercialize Simponi (golimumab), a fully human monoclonal antibody. The Company had exclusive
marketing rights to both products outside the United States, Japan and certain other Asian markets.
In December 2007, Schering-Plough and Centocor revised their distribution agreement regarding the
development, commercialization and distribution of both Remicade and Simponi, extending the
Companys rights to exclusively market Remicade to match the duration of the Companys exclusive
marketing rights for Simponi. In addition, Schering-Plough and Centocor agreed to share certain
development costs relating to Simponis auto-injector delivery system. On October 6, 2009, the
European Commission approved Simponi as a treatment for rheumatoid arthritis and other immune
system disorders in two presentations a novel auto-injector and a prefilled syringe. As a
result, the Companys marketing rights for both products extend for 15 years from the first
commercial sale of Simponi in the European Union (EU) following the receipt of pricing and
reimbursement approval within the EU. In April 2011, Merck and Johnson & Johnson reached agreement to amend the
distribution rights to Remicade and Simponi. Under the terms of the amended distribution agreement, Merck will
relinquish exclusive marketing rights for Remicade and Simponi to Johnson & Johnson in territories including Canada,
Central and South America, the Middle East, Africa and Asia Pacific
effective July 1, 2011. Merck will retain exclusive marketing rights
throughout Europe, Russia and Turkey (retained
territories). In addition, all profit
derived from Mercks exclusive distribution of the two products in the retained territories will be equally divided
between Merck and Johnson & Johnson, beginning July 1, 2011. Under the prior terms of the distribution agreement,
the contribution income (profit) split, which is currently at 58% to Merck and 42% percent to Johnson & Johnson,
would have declined for Merck and increased for Johnson & Johnson each year until 2014, when it would have been
equally divided. Johnson & Johnson also received a one-time payment of $500 million in April 2011, which the Company
recorded as charge to Other (income) expense, net in the first quarter of 2011.
5. Financial Instruments
Derivative Instruments and Hedging Activities
The Company manages the impact of foreign exchange rate movements and interest rate movements
on its earnings, cash flows and fair values of assets and liabilities through operational means and
through the use of various financial instruments, including derivative instruments.
A significant portion of the Companys revenues and earnings in foreign affiliates is exposed
to changes in foreign exchange rates. The objectives and accounting related to the Companys
foreign currency risk management program, as well as its interest rate risk management activities
are discussed below.
- 8 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Foreign Currency Risk Management
A significant portion of the Companys revenues are denominated in foreign currencies. The
Company has established revenue hedging and balance sheet risk management programs to protect
against volatility of future foreign currency cash flows and changes in fair value caused by
volatility in foreign exchange rates.
The objective of the revenue hedging program is to reduce the potential for longer-term
unfavorable changes in foreign exchange to decrease the U.S. dollar value of future cash flows
derived from foreign currency denominated sales, primarily the euro and Japanese yen. To achieve
this objective, the Company will partially hedge forecasted foreign currency denominated
third-party and intercompany distributor entity sales that are expected to occur over its planning
cycle, typically no more than three years into the future. The Company will layer in hedges over
time, increasing the portion of third-party and intercompany distributor entity sales hedged as it
gets closer to the expected date of the forecasted foreign currency denominated sales, such that it
is probable the hedged transaction will occur. The portion of sales hedged is based on assessments
of cost-benefit profiles that consider natural offsetting exposures, revenue and exchange rate
volatilities and correlations, and the cost of hedging instruments. The hedged anticipated sales
are a specified component of a portfolio of similarly denominated foreign currency-based sales
transactions, each of which responds to the hedged risk in the same manner. The Company manages
its anticipated transaction exposure principally with purchased local currency put options, which
provide the Company with a right, but not an obligation, to sell foreign currencies in the future
at a predetermined price. If the U.S. dollar strengthens relative to the currency of the hedged
anticipated sales, total changes in the options cash flows offset the decline in the expected
future U.S. dollar cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar
weakens, the options value reduces to zero, but the Company benefits from the increase in the
value of the anticipated foreign currency cash flows.
In connection with the Company's
revenue hedging program, a purchased collar option strategy may be utilized. With a purchased collar option strategy,
the Company writes a local currency call option and purchases a local currency put option. As compared to a purchased
put option strategy
alone, a purchased collar strategy reduces the upfront costs associated with purchasing puts through the collection
of premium by writing call options. If the U.S. dollar weakens relative to the currency of the hedged anticipated sales,
the purchased put option value of the collar strategy reduces to zero, but the Company benefit from the increase in the
value of its anticipated foreign currency cash flows would be capped at the strike level of the written call.
If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, the written call option
value of the collar strategy reduces to zero and the changes in the purchased put cash flows of the collar strategy
would offset the decline in the expected future U.S. dollar cash flows of the hedged foreign currency sales.
The
Company may also utilize forward contracts in its revenue hedging
program. If the U.S. dollar strengthens relative to the currency of
the hedged anticipated sales, the increase in the fair value of the
forward contracts offsets the decrease in the expected future U.S.
dollar cash flows of the hedged foreign currency sales. Conversely,
if the U.S. dollar weakens, the decrease in the fair value of the
forward contracts offsets the increase in the value of the
anticipated foreign currency cash flows.
The fair values of these derivative contracts are recorded as either assets (gain positions)
or liabilities (loss positions) in the Consolidated Balance Sheet. Changes in the fair value of
derivative contracts are recorded each period in either current earnings or Other comprehensive
income (OCI), depending on whether the derivative is designated as part of a hedge transaction,
and if so, the type of hedge transaction. For derivatives that are designated as cash flow hedges,
the effective portion of the unrealized gains or losses on these contracts is recorded in
Accumulated other comprehensive income (AOCI) and reclassified into Sales when the hedged
anticipated revenue is recognized. The hedge relationship is highly effective and hedge
ineffectiveness has been de minimis. For those derivatives which are not designated as cash flow
hedges, unrealized gains or losses are recorded to Sales each period. The cash flows from these
contracts are reported as operating activities in the Consolidated Statement of Cash Flows. The
Company does not enter into derivatives for trading or speculative purposes.
The primary objective of the balance sheet risk management program is to mitigate the exposure
of foreign currency denominated net monetary assets of foreign subsidiaries where the U.S. dollar
is the functional currency from the effects of volatility in foreign exchange that might occur
prior to their conversion to U.S. dollars. In these instances, Merck principally utilizes forward
exchange contracts, which enable the Company to buy and sell foreign currencies in the future at
fixed exchange rates and economically offset the consequences of changes in foreign exchange from
the monetary assets. Merck routinely enters into contracts to offset the effects of exchange on
exposures denominated in developed country currencies, primarily the euro and Japanese yen. For
exposures in developing country currencies, the Company will enter into forward contracts to
partially offset the effects of exchange on exposures when it is deemed economical to do so based
on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the
exchange rate and the cost of the hedging instrument. The Company will also minimize the effect of
exchange on monetary assets and liabilities by managing operating activities and net asset
positions at the local level.
Foreign currency denominated monetary assets and liabilities of foreign subsidiaries where the
U.S. dollar is the functional currency are remeasured at spot rates in effect on the balance sheet
date with the effects of changes in spot rates reported in Other (income) expense, net. The
forward contracts are not designated as hedges and are marked to market through Other (income)
expense, net. Accordingly, fair value changes in the forward contracts help mitigate the changes
in the value of the remeasured assets and liabilities attributable to changes in foreign currency
exchange rates, except to the extent of the spot-forward differences. These differences are not
significant due to the short-term nature of the contracts, which typically have average maturities
at inception of less than one year.
When applicable, the Company uses forward contracts to hedge the changes in fair value of
certain foreign currency denominated available-for-sale securities attributable to fluctuations in
foreign currency exchange rates. These derivative contracts are designated as fair value hedges.
Accordingly, changes in the fair value of the hedged securities due to fluctuations in spot rates
are recorded in Other (income) expense, net, and are offset by the fair value changes in the
forward contracts attributable to spot rate fluctuations. Changes in the contracts fair value due
to spot-forward differences are excluded from the designated hedge relationship and recognized in
Other (income) expense, net. These amounts, as well as hedge ineffectiveness, were not
significant. The cash flows from these contracts are reported as operating activities in the
Consolidated Statement of Cash Flows.
- 9 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Foreign exchange risk is also managed through the use of foreign currency debt. The Companys
senior unsecured euro-denominated notes have been designated as, and are effective as, economic
hedges of the net investment in a foreign operation. Accordingly, foreign currency transaction
gains or losses on the euro-denominated debt instruments are included in foreign currency
translation adjustment within OCI.
The Company also uses forward exchange contracts to hedge its net investment in foreign
operations against adverse movements in exchange rates. The forward contracts are designated as
hedges of the net investment in a foreign operation. The Company hedges a portion of the net
investment in certain of its foreign operations and measures ineffectiveness based upon changes in
spot foreign exchange rates. The effective portion of the unrealized gains or losses on these
contracts is recorded in foreign currency translation adjustment within OCI, and remains in OCI
until either the sale or complete or substantially complete liquidation of the subsidiary. The
cash flows from these contracts are reported as investing activities in the Consolidated Statement
of Cash Flows.
Interest Rate Risk Management
At March 31, 2011, the Company was a party to 22 pay-floating, receive-fixed interest rate swap
contracts designated as fair value hedges of fixed-rate notes in which the notional amounts match
the amount of the hedged fixed-rate notes. There are two swaps maturing in 2011 with notional
amounts of $125 million each that effectively convert the Companys $250 million, 5.125% fixed-rate
notes due 2011 to floating rate instruments. There are nine swaps maturing in 2015: two of which
have notional amounts of $250 million each and one of which has a notional amount of $500 million,
that effectively convert the Companys $1.0 billion, 4.75% fixed-rate notes due 2015 to floating
rate instruments; five swaps with notional amounts of $150 million each and one with a notional
amount of $250 million that effectively convert the Companys $1.0 billion, 4.0% fixed-rate notes
due 2015 to floating rate instruments. There are six swaps maturing in 2016, two of which have
notional amounts of $175 million each, and four of which have notional amounts of $125 million
each, that effectively convert the Companys $850 million, 2.25% fixed-rate notes due 2016 to
floating rate instruments. There are two swaps maturing in 2017, with notional amounts of $600
million and $400 million that effectively convert the $1.0 billion, 6.0% fixed-rate notes due in
2017 to floating rate instruments. There are three swaps maturing in 2019, two of which have
notional amounts of $500 million each, and one of which has a notional amount of $250 million that
effectively convert the Companys $1.25 billion, 5.0% fixed-rate notes due in 2019 to floating rate
instruments. The interest rate swap contracts are designated hedges of the fair value changes in
the notes attributable to changes in the benchmark London Interbank Offered Rate (LIBOR) swap
rate. The fair value changes in the notes attributable to changes in the benchmark interest rate
are recorded in interest expense and offset by the fair value changes in the swap contracts. The
cash flows from these contracts are reported as operating activities in the Consolidated Statement
of Cash Flows.
Presented in the table below is the fair value of derivatives segregated between those
derivatives that are designated as hedging instruments and those that are not designated as hedging
instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011 |
|
|
December 31, 2010 |
|
|
|
|
|
Fair Value of Derivative |
|
|
U.S. Dollar |
|
|
Fair Value of Derivative |
|
|
U.S. Dollar |
|
($ in millions) |
|
Balance Sheet Caption |
|
Asset |
|
|
Liability |
|
|
Notional |
|
|
Asset |
|
|
Liability |
|
|
Notional |
|
|
Derivatives Designated as Hedging Instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
exchange contracts (current) |
|
Deferred income taxes and other
current assets |
|
$ |
94 |
|
|
$ |
|
|
|
$ |
3,412 |
|
|
$ |
167 |
|
|
$ |
|
|
|
$ |
2,344 |
|
Foreign exchange contracts (non-current) |
|
Other assets |
|
|
263 |
|
|
|
|
|
|
|
4,329 |
|
|
|
310 |
|
|
|
|
|
|
|
3,720 |
|
Foreign exchange contracts (current) |
|
Accrued and other current liabilities |
|
|
|
|
|
|
25 |
|
|
|
2,071 |
|
|
|
|
|
|
|
18 |
|
|
|
1,505 |
|
Foreign exchange contracts (non-current) |
|
Deferred income taxes and
noncurrent liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
|
503 |
|
Interest rate swaps (current) |
|
Deferred
income taxes and other current assets |
|
|
11 |
|
|
|
|
|
|
|
250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swaps (non-current) |
|
Other assets |
|
|
85 |
|
|
|
|
|
|
|
4,250 |
|
|
|
56 |
|
|
|
|
|
|
|
1,000 |
|
Interest rate swaps (non-current) |
|
Deferred income taxes and
noncurrent liabilities |
|
|
|
|
|
|
10 |
|
|
|
850 |
|
|
|
|
|
|
|
7 |
|
|
|
850 |
|
|
|
|
|
|
$ |
453 |
|
|
$ |
35 |
|
|
$ |
15,162 |
|
|
$ |
533 |
|
|
$ |
31 |
|
|
$ |
9,922 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives Not Designated as Hedging Instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
exchange contracts (current) |
|
Deferred income taxes and other
current assets |
|
$ |
32 |
|
|
$ |
|
|
|
$ |
4,100 |
|
|
$ |
95 |
|
|
$ |
|
|
|
$ |
6,295 |
|
Foreign exchange contracts (current) |
|
Accrued and other current liabilities |
|
|
|
|
|
|
176 |
|
|
|
8,712 |
|
|
|
|
|
|
|
30 |
|
|
|
4,229 |
|
|
|
|
|
|
$ |
32 |
|
|
$ |
176 |
|
|
$ |
12,812 |
|
|
$ |
95 |
|
|
$ |
30 |
|
|
$ |
10,524 |
|
|
|
|
|
|
$ |
485 |
|
|
$ |
211 |
|
|
$ |
27,974 |
|
|
$ |
628 |
|
|
$ |
61 |
|
|
$ |
20,446 |
|
|
- 10 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The table below provides information on the location and pretax gain or loss amounts for
derivatives that are: (i) designated in a fair value hedging relationship, (ii) designated in a
cash flow hedging relationship, (iii) designated in a foreign currency hedging relationship (net
investment hedge) and (iv) not designated in a hedging relationship:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Derivatives designated in fair value hedging relationships |
|
|
|
|
|
|
|
|
Interest rate swap contracts |
|
|
|
|
|
|
|
|
Amount of gain recognized in Other (income) expense, net on derivatives |
|
$ |
(37 |
) |
|
$ |
(21 |
) |
Amount of loss recognized in Other (income) expense, net on hedged item |
|
|
37 |
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
Derivatives designated in foreign currency cash flow hedging relationships |
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
Amount of loss reclassified from AOCI to Sales |
|
|
7 |
|
|
|
19 |
|
Amount of loss (gain) recognized in OCI on derivatives |
|
|
184 |
|
|
|
(94 |
) |
|
|
|
|
|
|
|
|
|
Derivatives designated in foreign currency net investment hedging relationships |
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
Amount of gain recognized in Other (income) expense, net on derivatives (1) |
|
|
(6 |
) |
|
|
|
|
Amount of loss recognized in OCI on derivatives |
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated in a hedging relationship |
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
Amount of loss (gain) recognized in Other (income) expense, net on derivatives (2) |
|
|
316 |
|
|
|
(69 |
) |
Amount of gain recognized in Sales on hedged item |
|
|
|
|
|
|
(67 |
) |
|
|
|
|
(1) |
|
There was no ineffectiveness on the hedge. Represents the amount excluded from
hedge effectiveness testing. |
|
(2) |
|
These derivative contracts mitigate changes in the value of remeasured foreign
currency denominated monetary assets and liabilities attributable to changes in foreign
currency exchange rates. |
At March 31, 2011, the Company estimates $81 million of pretax net unrealized losses on
derivatives maturing within the next 12 months that hedge foreign currency denominated sales over
that same period will be reclassified from AOCI to Sales. The amount ultimately reclassified to
Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately
determined by actual exchange rates at maturity.
Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to
transfer a liability (an exit price) in the principal or most advantageous market for the asset or
liability in an orderly transaction between market participants on the measurement date. Entities
are required to use a fair value hierarchy which maximizes the use of observable inputs and
minimizes the use of unobservable inputs when measuring fair value. There are three levels of
inputs that may be used to measure fair value:
Level 1 - Quoted prices in active markets for identical assets or liabilities. The Companys
Level 1 assets include equity securities that are traded in an active exchange market.
Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar
assets or liabilities, or other inputs that are observable or can be corroborated by observable
market data for substantially the full term of the assets or liabilities. The Companys Level 2
assets and liabilities primarily include debt securities with quoted prices that are traded less
frequently than exchange-traded instruments, corporate notes and bonds, U.S. and foreign government
and agency securities, certain mortgage-backed and asset-backed securities, municipal securities,
commercial paper and derivative contracts whose values are determined using pricing models with
inputs that are observable in the market or can be derived principally from or corroborated by
observable market data.
Level 3 - Unobservable inputs that are supported by little or no market activity and that are
financial instruments whose values are determined using pricing models, discounted cash flow
methodologies, or similar techniques, as well as instruments for which the determination of fair
value requires significant judgment or estimation. The Companys
Level 3 assets included certain
mortgage-backed securities with limited market activity.
If the inputs used to measure the financial assets and liabilities fall within more than one
level described above, the categorization is based on the lowest level input that is significant to
the fair value measurement of the instrument.
- 11 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis
Financial assets and liabilities measured at fair value on a recurring basis are summarized
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using |
|
|
|
|
|
|
Fair Value Measurements Using |
|
|
|
|
|
|
Quoted Prices |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
Quoted Prices |
|
|
Significant |
|
|
|
|
|
|
|
|
|
In Active |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
In Active |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
Markets for |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
Markets for |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
|
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
|
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
($ in millions) |
|
|
|
|
|
March 31, 2011 |
|
|
|
|
|
|
|
|
|
|
December 31, 2010 |
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate notes and bonds |
|
$ |
|
|
|
$ |
1,174 |
|
|
$ |
|
|
|
$ |
1,174 |
|
|
$ |
|
|
|
$ |
1,133 |
|
|
$ |
|
|
|
$ |
1,133 |
|
Commercial paper |
|
|
|
|
|
|
1,095 |
|
|
|
|
|
|
|
1,095 |
|
|
|
|
|
|
|
1,046 |
|
|
|
|
|
|
|
1,046 |
|
U.S. government and
agency securities |
|
|
|
|
|
|
384 |
|
|
|
|
|
|
|
384 |
|
|
|
|
|
|
|
500 |
|
|
|
|
|
|
|
500 |
|
Municipal securities |
|
|
|
|
|
|
305 |
|
|
|
|
|
|
|
305 |
|
|
|
|
|
|
|
361 |
|
|
|
|
|
|
|
361 |
|
Asset-backed securities(1) |
|
|
|
|
|
|
167 |
|
|
|
|
|
|
|
167 |
|
|
|
|
|
|
|
171 |
|
|
|
|
|
|
|
171 |
|
Mortgage-backed securities(1) |
|
|
|
|
|
|
90 |
|
|
|
|
|
|
|
90 |
|
|
|
|
|
|
|
99 |
|
|
|
13 |
|
|
|
112 |
|
Foreign government bonds |
|
|
|
|
|
|
65 |
|
|
|
|
|
|
|
65 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
10 |
|
Equity securities |
|
|
111 |
|
|
|
24 |
|
|
|
|
|
|
|
135 |
|
|
|
117 |
|
|
|
23 |
|
|
|
|
|
|
|
140 |
|
Other debt securities |
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
111 |
|
|
|
3,307 |
|
|
|
|
|
|
|
3,418 |
|
|
|
117 |
|
|
|
3,346 |
|
|
|
13 |
|
|
|
3,476 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities held for employee
compensation |
|
|
191 |
|
|
|
|
|
|
|
|
|
|
|
191 |
|
|
|
181 |
|
|
|
|
|
|
|
|
|
|
|
181 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative assets (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased currency options |
|
|
|
|
|
|
357 |
|
|
|
|
|
|
|
357 |
|
|
|
|
|
|
|
477 |
|
|
|
|
|
|
|
477 |
|
Forward exchange contracts |
|
|
|
|
|
|
32 |
|
|
|
|
|
|
|
32 |
|
|
|
|
|
|
|
95 |
|
|
|
|
|
|
|
95 |
|
Interest rate swaps |
|
|
|
|
|
|
96 |
|
|
|
|
|
|
|
96 |
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
|
|
485 |
|
|
|
|
|
|
|
485 |
|
|
|
|
|
|
|
628 |
|
|
|
|
|
|
|
628 |
|
|
Total assets |
|
$ |
302 |
|
|
$ |
3,792 |
|
|
$ |
|
|
|
$ |
4,094 |
|
|
$ |
298 |
|
|
$ |
3,974 |
|
|
$ |
13 |
|
|
$ |
4,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative liabilities (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forward exchange contracts |
|
$ |
|
|
|
$ |
201 |
|
|
$ |
|
|
|
$ |
201 |
|
|
$ |
|
|
|
$ |
54 |
|
|
$ |
|
|
|
$ |
54 |
|
Interest rate swaps |
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
7 |
|
|
|
|
|
|
|
7 |
|
|
Total liabilities |
|
$ |
|
|
|
$ |
211 |
|
|
$ |
|
|
|
$ |
211 |
|
|
$ |
|
|
|
$ |
61 |
|
|
$ |
|
|
|
$ |
61 |
|
|
|
|
|
(1) |
|
Substantially all of the asset-backed securities are highly-rated (Standard & Poors
rating of AAA and Moodys Investors Service rating of Aaa), secured primarily by credit card,
auto loan, and home equity receivables, with weighted-average lives of primarily 5 years or
less. Mortgage-backed securities represent AAA-rated securities issued or unconditionally
guaranteed as to payment of principal and interest by U.S. government agencies. |
|
(2) |
|
The fair value determination of derivatives includes an assessment of the credit
risk of counterparties to the derivatives and the Companys own credit risk, the effects of
which were not significant. |
There were no significant transfers between Level 1 and Level 2 during the first quarter
of 2011. As of March 31, 2011, Cash and cash equivalents of $11.7 billion included $11.0 billion
of cash equivalents.
Level 3 Valuation Techniques:
Financial assets are considered Level 3 when their fair values are determined using pricing
models, discounted cash flow methodologies or similar techniques and at least one significant model
assumption or input is unobservable. Level 3 financial assets also include certain investment
securities for which there is limited market activity such that the determination of fair value
requires significant judgment or estimation. The Companys Level 3 investment securities included
certain mortgage-backed securities that were valued primarily using pricing models
for which management understands the methodologies. These models incorporate transaction details
such as contractual terms, maturity, timing and amount of future cash inflows, as well as
assumptions about liquidity and credit valuation adjustments of marketplace participants.
- 12 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
The table below provides a summary of the changes in fair value of all financial assets
measured at fair value on a recurring basis using significant unobservable inputs (Level 3):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2011 |
|
|
Three Months Ended March 31, 2010 |
|
|
|
Available- |
|
|
|
|
|
|
|
|
|
|
Available- |
|
|
|
|
|
|
|
|
|
for-sale |
|
|
Other |
|
|
|
|
|
|
for-sale |
|
|
Other |
|
|
|
|
($ in millions) |
|
investments |
|
|
assets |
|
|
Total |
|
|
investments |
|
|
assets |
|
|
Total |
|
|
Beginning balance January 1 |
|
$ |
13 |
|
|
$ |
|
|
|
$ |
13 |
|
|
$ |
|
|
|
$ |
72 |
|
|
$ |
72 |
|
Sales |
|
|
(13 |
) |
|
|
|
|
|
|
(13 |
) |
|
|
|
|
|
|
(52 |
) |
|
|
(52 |
) |
Settlements |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
|
(2 |
) |
Total realized and unrealized gains (losses) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13 |
|
|
|
13 |
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11 |
) |
|
|
(11 |
) |
|
Ending balance March 31 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
20 |
|
|
$ |
20 |
|
|
Losses recorded in earnings for Level 3
assets still held at March 31 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(2 |
) |
|
$ |
(2 |
) |
|
|
|
|
(1) |
|
Amounts are recorded in Other (income) expense, net. |
Financial Instruments not Measured at Fair Value
Some of the Companys financial instruments are not measured at fair value on a recurring
basis but are recorded at amounts that approximate fair value due to their liquid or short-term
nature, such as cash and cash equivalents, receivables and payables.
The estimated fair value of loans payable and long-term debt (including current portion) at
March 31, 2011 was $18.3 billion compared with a carrying value of $17.8 billion and at December
31, 2010 was $18.7 billion compared with a carrying value of $17.9 billion. Fair value was
estimated using quoted dealer prices.
A summary of gross unrealized gains and losses on available-for-sale investments recorded in
AOCI is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011 |
|
December 31, 2010 |
|
|
Fair |
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Fair |
|
|
Amortized |
|
|
Gross Unrealized |
|
($ in millions) |
|
Value |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
|
|
|
|
|
|
Corporate notes and bonds |
|
$ |
1,174 |
|
|
$ |
1,167 |
|
|
$ |
10 |
|
|
$ |
(3 |
) |
|
$ |
1,133 |
|
|
$ |
1,124 |
|
|
$ |
12 |
|
|
$ |
(3 |
) |
Commercial paper |
|
|
1,095 |
|
|
|
1,095 |
|
|
|
|
|
|
|
|
|
|
|
1,046 |
|
|
|
1,046 |
|
|
|
|
|
|
|
|
|
U.S. government and agency
securities |
|
|
384 |
|
|
|
386 |
|
|
|
1 |
|
|
|
(3 |
) |
|
|
500 |
|
|
|
501 |
|
|
|
1 |
|
|
|
(2 |
) |
Municipal securities |
|
|
305 |
|
|
|
304 |
|
|
|
3 |
|
|
|
(2 |
) |
|
|
361 |
|
|
|
359 |
|
|
|
4 |
|
|
|
(2 |
) |
Asset-backed securities |
|
|
167 |
|
|
|
166 |
|
|
|
1 |
|
|
|
|
|
|
|
171 |
|
|
|
170 |
|
|
|
1 |
|
|
|
|
|
Mortgage-backed securities |
|
|
90 |
|
|
|
90 |
|
|
|
|
|
|
|
|
|
|
|
112 |
|
|
|
108 |
|
|
|
5 |
|
|
|
(1 |
) |
Foreign government bonds |
|
|
65 |
|
|
|
59 |
|
|
|
6 |
|
|
|
|
|
|
|
10 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
Other debt securities |
|
|
3 |
|
|
|
1 |
|
|
|
2 |
|
|
|
|
|
|
|
3 |
|
|
|
1 |
|
|
|
2 |
|
|
|
|
|
Equity securities |
|
|
326 |
|
|
|
298 |
|
|
|
28 |
|
|
|
|
|
|
|
321 |
|
|
|
295 |
|
|
|
34 |
|
|
|
(8 |
) |
|
|
|
$ |
3,609 |
|
|
$ |
3,566 |
|
|
$ |
51 |
|
|
$ |
(8 |
) |
|
$ |
3,657 |
|
|
$ |
3,614 |
|
|
$ |
59 |
|
|
$ |
(16 |
) |
|
Available-for-sale debt securities included in Short-term investments totaled $1.3 billion at
March 31, 2011. Of the remaining debt securities, $1.6 billion mature within five years. At March
31, 2011, there were no debt securities pledged as collateral.
Concentrations of Credit Risk
On an ongoing basis, the Company monitors concentrations of credit risk associated with
corporate issuers of securities and financial institutions with which it conducts business. Credit
exposure limits are established to limit a concentration with any single issuer or institution.
Cash and investments are placed in instruments that meet high credit quality standards, as
specified in the
Companys investment policy guidelines. Approximately half of the Companys cash and cash
equivalents are invested in three highly-rated money market funds.
- 13 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
The majority of the Companys accounts receivable arise from product sales in the United
States and Europe and are primarily due from drug wholesalers and retailers, hospitals, government
agencies, managed health care providers and pharmacy benefit managers. The Company monitors the
financial performance and credit worthiness of its customers so that it can properly assess and
respond to changes in their credit profile. The Company also continues to monitor economic
conditions, including the volatility associated with international sovereign economies, and
associated impacts on the financial markets and its business, taking into consideration the global
economic downturn and the sovereign debt issues in certain European countries. The Company
continues to monitor the credit and economic conditions within Greece, Spain, Italy and Portugal,
among other members of the EU. These deteriorating economic conditions, as well as
inherent variability of timing of cash receipts, have resulted in, and may continue to result in,
an increase in the average length of time that it takes to collect accounts receivable outstanding.
As of March 31, 2011, the Companys accounts receivable in Greece, Italy, Spain and Portugal
totaled approximately $1.5 billion of which hospital and public sector receivables in Greece were
approximately 7%. As of March 31, 2011, the Companys total accounts receivable outstanding for
more than one year were approximately $345 million, of which approximately $285 million related to
accounts receivable in Greece, Italy, Spain and Portugal, mostly comprised of hospital and public sector receivables.
Derivative financial instruments are executed under International Swaps and Derivatives
Association master agreements. The master agreements with several of the Companys financial
institution counterparties also include credit support annexes. These annexes contain provisions
that require collateral to be exchanged depending on the value of the derivative assets and
liabilities, the Companys credit rating, and the credit rating of the counterparty. As of March
31, 2011 and December 31, 2010, the Company had received cash collateral of $3 million and $157
million, respectively, from various counterparties which is recorded in Accrued and other current
liabilities. The Company had not advanced any cash collateral to counterparties as of March 31,
2011 or December 31, 2010.
6. Inventories
Inventories consisted of:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Finished goods |
|
$ |
1,384 |
|
|
$ |
1,484 |
|
Raw materials and work in process |
|
|
5,801 |
|
|
|
5,449 |
|
Supplies |
|
|
306 |
|
|
|
315 |
|
|
Total (approximates current cost) |
|
|
7,491 |
|
|
|
7,248 |
|
Reduction to LIFO costs |
|
|
(170 |
) |
|
|
(186 |
) |
|
|
|
$ |
7,321 |
|
|
$ |
7,062 |
|
|
Recognized as: |
|
|
|
|
|
|
|
|
Inventories |
|
$ |
6,057 |
|
|
$ |
5,868 |
|
Other assets |
|
|
1,264 |
|
|
|
1,194 |
|
|
As
of March 31, 2011 and December 31, 2010, $175 million and $225 million, respectively, of
purchase accounting adjustments to inventories remained which are recognized as a component of
Materials and production costs as the related inventories are sold. Amounts recognized as Other
assets are comprised almost entirely of raw materials and work in process inventories. At
March 31, 2011 and at December 31, 2010, these amounts included $1.0 billion of inventories not
expected to be sold within one year, principally vaccines. In
addition, these amounts included $262 million and
$197 million at March 31, 2011 and December 31, 2010, respectively, of inventories
produced in preparation for product launches, including
Victrelis (boceprevir) which is currently under review with the
U.S. Food and Drug Administration (FDA).
7. Other Intangibles
At
the time of the Merger, the Company measured the fair value of legacy
Schering-Plough pipeline programs and capitalized these amounts.
During the first quarter of 2011, the Company recorded $302 million of in-process research and
development (IPR&D) impairment charges within
Research and development expenses primarily for programs
that had previously been deprioritized and were deemed to have no alternative use during the quarter. During the
first quarter of 2010, the Company recorded $27 million of IPR&D impairment charges attributable to
compounds identified during the Companys pipeline prioritization review that were abandoned and
determined to have either no alternative use or were returned to the respective licensor. The
Company may recognize additional non-cash impairment charges in the future for the cancellation of
other legacy Schering-Plough pipeline programs and such charges could be material.
- 14 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
8. Joint Ventures and Other Equity Method Affiliates
Equity income from affiliates reflects the performance of the Companys joint ventures and
other equity method affiliates and was comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
| | |
AstraZeneca LP |
|
$ |
133 |
|
|
$ |
125 |
|
Other (1) |
|
|
5 |
|
|
|
13 |
|
|
|
|
$ |
138 |
|
|
$ |
138 |
|
|
|
|
|
(1) |
|
Primarily reflects results from Sanofi Pasteur MSD and Johnson & Johnson°Merck
Consumer Pharmaceuticals Company. |
AstraZeneca LP
In 1998, Old Merck and Astra completed the restructuring of the ownership and operations of
their existing joint venture whereby Old Merck acquired Astras interest in KBI Inc. (KBI) and
contributed KBIs operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P.
(the Partnership), in exchange for a 1% limited partner interest. Astra contributed the net
assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership in exchange for a 99%
general partner interest. The Partnership, renamed AstraZeneca LP (AZLP) upon Astras 1999 merger
with Zeneca Group Plc (the AstraZeneca merger), became the exclusive distributor of the products
for which KBI retained rights.
In connection with the 1998 restructuring, Astra purchased an option (the Asset Option) for
a payment of $443 million, which was recorded as deferred income, to buy Old Mercks interest in
the KBI products, excluding the gastrointestinal medicines Nexium and Prilosec (the Non-PPI
Products). In April 2010, AstraZeneca exercised the Asset Option. Merck received $647 million
from AstraZeneca, representing the net present value as of March 31, 2008 of projected future
pretax revenue to be received by Old Merck from the Non-PPI Products, which was recorded as a
reduction to the Companys investment in AZLP. The Company recognized the $443 million of
deferred income in the second quarter of 2010 as a component of Other (income) expense, net. In
addition, in 1998, Old Merck granted Astra an option (the Shares Option) to buy Old Mercks
common stock interest in KBI and, therefore, Old Mercks interest in Nexium and Prilosec,
exercisable in 2012. The exercise price for the Shares Option will be based on the net present
value of estimated future net sales of Nexium and Prilosec as determined at the time of exercise,
subject to certain true-up mechanisms. The Company believes that it is likely that AstraZeneca
will exercise the Shares Option.
Summarized financial information for AZLP is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
| | |
Sales |
|
$ |
1,155 |
|
|
$ |
1,293 |
|
Materials and production costs |
|
|
545 |
|
|
|
633 |
|
Other expense, net |
|
|
300 |
|
|
|
142 |
|
|
Income before taxes (1) |
|
$ |
310 |
|
|
$ |
518 |
|
|
|
|
|
(1) |
|
Mercks partnership returns from AZLP are generally contractually determined and
are not based on a percentage of income from AZLP, other than with respect to the 1% limited
partnership interest discussed above. |
Other
In March 2011, Merck and sanofi-aventis mutually terminated their agreement to form a new
animal health joint venture by combining Intervet/Schering-Plough, Mercks animal health unit, with
Merial, the animal health business of sanofi-aventis. As a result of the termination, both Merial
and Intervet/Schering-Plough continue to operate independently. The termination of the agreement
was without penalty to either party.
- 15 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
9. Contingencies
The Company is involved in various claims and legal proceedings of a nature considered normal
to its business, including product liability, intellectual property, and commercial litigation, as
well as additional matters such as antitrust actions.
Vioxx Litigation
Product Liability Lawsuits
As previously disclosed, individual and putative class actions have been filed against Old
Merck in state and federal courts alleging personal injury and/or economic loss with respect to the
purchase or use of Vioxx. All such actions filed in federal court are coordinated in a
multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana (the
MDL) before District Judge Eldon E. Fallon. A number of such actions filed in state court are
coordinated in separate coordinated proceedings in state courts in California and Texas, and the
counties of Philadelphia, Pennsylvania and Washoe and Clark Counties, Nevada. (All of the actions
discussed in this paragraph and in Other Lawsuits below are collectively referred to as the
Vioxx Product Liability Lawsuits.)
Of the plaintiff groups in the Vioxx Product Liability Lawsuits described above, the vast
majority were dismissed as a result of the Vioxx Settlement Program, which has been described previously. As of
March 31, 2011, approximately 30 plaintiff groups who were otherwise eligible for the Settlement
Program did not participate and their claims remain pending against Old Merck. In addition, the
claims of approximately 120 plaintiff groups who were not eligible for the Settlement Program
remain pending against Old Merck. A number of these 120 plaintiff groups are subject to various
motions to dismiss for failure to comply with court-ordered deadlines.
There is one U.S. Vioxx Product Liability Lawsuit currently scheduled for trial in 2011.
Old Merck has previously disclosed the outcomes of several Vioxx Product Liability Lawsuits that
were tried prior to 2010. Of the cases that went to trial, there are two unresolved post-trial
appeals: Ernst v. Merck and Garza v. Merck. Merck has previously disclosed the details associated
with these cases and the grounds for Mercks appeals.
Other Lawsuits
There are still pending in various U.S. courts putative class actions purportedly brought on
behalf of individual purchasers or users of Vioxx seeking reimbursement for alleged economic loss.
In the MDL proceeding, approximately 30 such class actions remain. On June 30, 2010, Old Merck
moved to strike the class claims or for judgment on the pleadings regarding the master complaint,
which includes the above-referenced cases, and briefing on that motion was completed on September
23, 2010. The MDL court heard oral argument on Old Mercks motion on October 7, 2010, and took it
under advisement.
On June 12, 2008, a Missouri state court certified a class of Missouri plaintiffs seeking
reimbursement for out-of-pocket costs relating to Vioxx. Trial is scheduled to begin in May 2012.
In addition, in Indiana, plaintiffs have filed a motion to certify a class of Indiana Vioxx
purchasers in a case pending before the Circuit Court of Marion County, Indiana. On April 1, 2010,
a Kentucky state court denied Old Mercks motion for summary judgment and certified a class of
Kentucky plaintiffs seeking reimbursement for out-of-pocket costs relating to Vioxx. The Kentucky
Court of Appeals denied Old Mercks petition for a writ of mandamus, and the Kentucky Supreme Court
has affirmed that ruling. The trial court entered an amended class certification order on January
27, 2011, and Merck has appealed that ruling to the Kentucky Court of Appeals.
Old Merck has also been named as a defendant in several lawsuits brought by, or on behalf of,
government entities. Twelve of these suits are being brought by state Attorneys General, one on
behalf of a county, and one is being brought by a private citizen (as a qui tam suit). All of
these actions, except for a suit brought by the Attorney General of Michigan, are in the MDL
proceeding. The Michigan Attorney General case was remanded to state court. The trial court
denied Mercks motion to dismiss, but the Court of Appeals reversed that ruling on March 17, 2011,
ordering the trial court to dismiss the case. These actions allege that Old Merck misrepresented
the safety of Vioxx. All but one of these suits seeks recovery for expenditures on Vioxx by
government-funded health care programs such as Medicaid, along with other relief such as penalties
and attorneys fees. An action brought by the Attorney General of Kentucky seeks only penalties
for alleged Consumer Fraud Act violations. The lawsuit brought by the county is a class action
filed by Santa Clara County, California on behalf of all similarly situated California counties.
Old Merck moved to dismiss the False Claims Act claims brought by a qui tam plaintiff on behalf of
the District of Columbia in November 2010. The court granted that motion on March 28, 2011. Old
Merck also moved to dismiss the case brought by the Attorney General of Oklahoma in December 2010.
On March 31, 2010, Judge Fallon partially granted and partially denied Old Mercks motion for
summary judgment in the Louisiana Attorney General case. A trial on the remaining claims before
Judge Fallon began on April 12, 2010 and was completed on April 21, 2010. Judge Fallon found in
favor of Old Merck on June 29, 2010, dismissing the Attorney Generals remaining claims with
prejudice. The Louisiana Attorney General is appealing that ruling.
- 16 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
Shareholder Lawsuits
As previously disclosed, in addition to the Vioxx Product Liability Lawsuits, various putative
class actions and individual lawsuits under federal and state securities laws have been filed
against Old Merck and various current and former officers and directors (the Vioxx Securities
Lawsuits). As previously disclosed, the Vioxx Securities Lawsuits have been transferred by the
Judicial Panel on Multidistrict Litigation (the JPML) to the U.S. District Court for the District
of New Jersey before District Judge Stanley R. Chesler for inclusion in a nationwide MDL (the
Shareholder MDL), and have been consolidated for all purposes. In June 2010, Old Merck moved to
dismiss the Fifth Amended Class Action Complaint in the consolidated securities action. Plaintiffs
filed their opposition in August 2010, and Old Merck filed its reply in September 2010. The motion
is currently pending before the district court.
As previously disclosed, several individual securities lawsuits filed by foreign institutional
investors also are consolidated with the Vioxx Securities Lawsuits. By stipulation, defendants are
not required to respond to these complaints until the resolution of any motions to dismiss in the
consolidated securities class action.
In addition, as previously disclosed, various putative class actions have been filed in
federal court under the Employee Retirement Income Security Act (ERISA) against Old Merck and
certain current and former officers and directors (the Vioxx ERISA Lawsuits). Those cases were
consolidated in the Shareholder MDL before Judge Chesler. Fact discovery in the Vioxx ERISA
Lawsuits closed on September 30, 2010. The Court has entered a schedule for expert discovery,
dispositive motions, and a pre-trial conference. Motions for summary judgment must be filed by
June 30, 2011.
International Lawsuits
As previously disclosed, in addition to the lawsuits discussed above, Old Merck has been named
as a defendant in litigation relating to Vioxx in Australia, Brazil, Canada, Europe and Israel
(collectively, the Vioxx Foreign Lawsuits).
In Canada, in 2006, the Superior Court in Quebec authorized a class action on behalf of Vioxx
users in Quebec who alleged negligence and, in 2008, the Superior Court of Ontario certified a
class of Vioxx users in Canada, except those in Quebec and Saskatchewan, who alleged negligence and
an entitlement to elect to waive the tort. These procedural decisions in the Canadian litigation
do not address the merits of the plaintiffs claims and litigation in Canada remains in an early
stage.
Insurance
As previously disclosed, the Company has Directors and Officers insurance coverage applicable
to the Vioxx Securities Lawsuits with remaining stated upper limits of approximately $175 million.
The Company has Fiduciary and other insurance for the Vioxx ERISA Lawsuits with stated upper limits
of approximately $275 million. As a result of the previously disclosed insurance arbitration, additional
insurance coverage for these claims should also be available, if needed, under upper-level excess
policies that provide coverage for a variety of risks. There are disputes with the insurers about
the availability of some or all of the Companys insurance coverage for these claims and there are
likely to be additional disputes. The amounts actually recovered under the policies discussed in
this paragraph may be less than the stated upper limits.
Investigations
As previously disclosed, Old Merck has received subpoenas from the Department of Justice
(DOJ) requesting information related to Old Mercks research, marketing and selling activities
with respect to Vioxx in a federal health care investigation under criminal statutes. This
investigation included subpoenas for witnesses to appear before a grand jury. As previously
disclosed, in March 2009, Old Merck received a letter from the U.S. Attorneys Office for the
District of Massachusetts identifying it as a target of the grand jury investigation regarding
Vioxx. On October 29, 2010, the Company announced that it had established a $950 million reserve
(the Vioxx Liability Reserve) in connection with the anticipated resolution of the DOJs
investigation. The Companys discussions with the government are ongoing. Until they are
concluded, there can be no certainty about a definitive resolution. The Company is cooperating
with the DOJ in its investigation (the Vioxx Investigation). The Company cannot predict the
outcome of these inquiries; however, they could result in potential civil and/or criminal remedies.
Reserves
There was one U.S. Vioxx Product Liability Lawsuit tried in 2010. There is one U.S. Vioxx
Product Liability Lawsuit currently scheduled for trial in 2011. The Company cannot predict the
timing of any other trials related to the Vioxx Litigation (as defined below). The Company
believes that it has meritorious defenses to the Vioxx Product Liability Lawsuits, Vioxx
Shareholder Lawsuits and Vioxx Foreign Lawsuits (collectively, the Vioxx Lawsuits) and will
vigorously defend against them. In view of the inherent difficulty of predicting the outcome of
litigation, particularly where there are many claimants and the claimants seek indeterminate
damages, the Company is unable to predict the outcome of these matters, and at this time cannot
reasonably estimate the possible loss or range of loss with respect to the Vioxx Lawsuits not
included in the Settlement Program. Unfavorable outcomes in the Vioxx Litigation could have a
material adverse effect on the Companys financial position, liquidity and results of operations.
- 17 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
Legal defense costs expected to be incurred in connection with a loss contingency are accrued
when probable and reasonably estimable.
As of December 31, 2010, the Company had an aggregate
reserve of approximately $76 million (the Vioxx Legal Defense Costs Reserve) solely for future
legal defense costs related to the Vioxx Litigation.
During the first quarter of 2011, the Company spent approximately $16 million in the aggregate
in legal defense costs worldwide related to (i) the Vioxx Product Liability Lawsuits, (ii) the
Vioxx Shareholder Lawsuits, (iii) the Vioxx Foreign Lawsuits, and (iv) the Vioxx Investigation
(collectively, the Vioxx Litigation). Consequently, as of March 31, 2011, the aggregate amount
of the Vioxx Legal Defense Costs Reserve was approximately $60 million, which is solely for future
legal defense costs for the Vioxx Litigation. Some of the significant factors considered in the
review of the Vioxx Legal Defense Costs Reserve were as follows: the actual costs incurred by the
Company; the development of the Companys legal defense strategy and structure in light of the
scope of the Vioxx Litigation, including the Settlement Agreement and the expectation that certain
lawsuits will continue to be pending; the number of cases being brought against the Company; the
costs and outcomes of completed trials and the most current information regarding anticipated
timing, progression, and related costs of pre-trial activities and trials in the Vioxx Litigation.
The amount of the Vioxx Legal Defense Costs Reserve as of March 31, 2011 represents the Companys
best estimate of the minimum amount of defense costs to be incurred in connection with the
remaining aspects of the Vioxx Litigation; however, events such as additional trials in the Vioxx
Litigation and other events that could arise in the course of the Vioxx Litigation could affect the
ultimate amount of defense costs to be incurred by the Company.
The Company will continue to monitor its legal defense costs and review the adequacy of the
associated reserves and may determine to increase the Vioxx Legal Defense Costs Reserve at any time
in the future if, based upon the factors set forth, it believes it would be appropriate to do so.
Other Product Liability Litigation
Fosamax
As previously disclosed, Old Merck is a defendant in product liability lawsuits in the United
States involving Fosamax (the Fosamax Litigation). As of March 31, 2011, approximately 1,450
cases, which include approximately 1,890 plaintiff groups, had been filed and were pending against
Old Merck in either federal or state court, including one case which seeks class action
certification, as well as damages and/or medical monitoring. In approximately 1,080 of these
actions, plaintiffs allege, among other things, that they have suffered osteonecrosis of the jaw
(ONJ), generally subsequent to invasive dental procedures, such as tooth extraction or dental
implants and/or delayed healing, in association with the use of Fosamax. In addition, plaintiffs
in approximately 365 of these actions generally allege that they sustained femur fractures and/or
other bone injuries in association with the use of Fosamax.
Cases Alleging ONJ and/or Other Jaw Related Injuries
In August 2006, the JPML ordered that certain Fosamax product liability cases pending in
federal courts nationwide should be transferred and consolidated into one multidistrict litigation
(the Fosamax MDL) for coordinated pre-trial proceedings. The Fosamax MDL has been transferred to
Judge John Keenan in the U.S. District Court for the Southern District of New York. As a result of
the JPML order, approximately 900 of the cases are before Judge Keenan. Judge Keenan issued a Case
Management Order (and various amendments thereto) which set forth a schedule governing the
proceedings focused primarily upon resolving the class action certification motions in 2007 and
completing fact discovery in an initial group of 25 cases by October 1, 2008. Briefing and
argument on plaintiffs motions for certification of medical monitoring classes were completed in
2007 and Judge Keenan issued an order denying the motions on January 3, 2008. In January 2008,
Judge Keenan issued a further order dismissing with prejudice all class claims asserted in the
first four class action lawsuits filed against Old Merck that sought personal injury damages and/or
medical monitoring relief on a class wide basis. Daubert motions were filed in May 2009 and Judge
Keenan conducted a Daubert hearing in July 2009. In July 2009, Judge Keenan issued his ruling on
the parties respective Daubert motions. The ruling denied the Plaintiff Steering Committees
motion and granted in part and denied in part Old Mercks motion. In the first Fosamax MDL trial,
Boles v. Merck, the Fosamax MDL court declared a mistrial because the eight person jury could not
reach a unanimous verdict. The Boles case was retried in June 2010 and resulted in a verdict in
favor of the plaintiff in the amount of $8 million. Merck filed post-trial motions seeking
judgment as a matter of law or, in the alternative, a new trial. On October 4, 2010, the court
denied Mercks post-trial motions but sua sponte ordered a remittitur, reducing the verdict to $1.5
million. Plaintiff rejected the remittitur ordered by the court and requested a new trial on
damages. The Company has filed a motion for interlocutory appeal.
In the next Fosamax MDL case set for trial, Maley v. Merck, the jury in May 2010 returned a
unanimous verdict in Mercks favor. On February 1, 2010, Judge Keenan selected a new bellwether
case, Judith Graves v. Merck, to replace the Flemings bellwether case, which the Fosamax MDL court
dismissed when it granted summary judgment in favor of Old Merck. In November 2010, the Second
Circuit affirmed the Courts granting of summary judgment in favor of Old Merck in the Flemings
case. In Graves, the jury returned a unanimous verdict in favor of Old Merck in November 2010.
- 18 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
The next trials scheduled in the Fosamax MDL are Secrest v. Merck, which was scheduled to
begin on March 14, 2011, but has been continued until September 7, 2011, and Hester v. Merck, which
was scheduled to begin on May 9, 2011, but after Merck filed its motion for summary judgment,
plaintiffs counsel dismissed Hester with prejudice. On
April 27, 2011, Judge Keenan selected Raber v. Merck as the
case to replace Hester and set the trial for Raber to begin on November 7, 2011. In addition, Judge
Keenan ordered on February 4, 2011 that there will be two further bellwether trials conducted in
the Fosamax MDL. The cases to be tried and the trial dates for those cases have not yet been
determined.
Outside the Fosamax MDL, a trial in Florida was scheduled to begin on June 21, 2010 but the
Florida state court postponed the trial date and a new date has been set for March 5, 2012.
In addition, in July 2008, an application was made by the Atlantic County Superior Court of
New Jersey requesting that all of the Fosamax cases pending in New Jersey be considered for mass
tort designation and centralized management before one judge in New Jersey. In October 2008, the
New Jersey Supreme Court ordered that all pending and future actions filed in New Jersey arising
out of the use of Fosamax and seeking damages for existing dental and jaw-related injuries,
including ONJ, but not solely seeking medical monitoring, be designated as a mass tort for
centralized management purposes before Judge Higbee in Atlantic County Superior Court. As of March
31, 2011, approximately 180 ONJ cases were pending against Old Merck in Atlantic County, New
Jersey. On July 20, 2009, Judge Higbee entered a Case Management Order (and various amendments
thereto) setting forth a schedule that contemplates completing fact and expert discovery in an
initial group of cases to be worked up for trial. On February 14, 2011, the jury in Rosenberg v.
Merck, the first trial in the New Jersey coordinated proceeding, returned a verdict in Mercks
favor.
Discovery is ongoing in the Fosamax MDL litigation, the New Jersey coordinated proceeding, and
the remaining jurisdictions where Fosamax cases are pending. The Company intends to defend against
these lawsuits.
Cases Alleging Femur Fractures and/or Other Bone Injuries
As of March 31, 2011, approximately 310 cases alleging femur fractures and/or other bone injuries have been filed in
New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. A
Case Management Order setting forth a schedule with respect to the work-up of these cases is
expected but has not yet been entered and no trial dates for any of the New Jersey state femur
fracture cases has been set.
On March 23, 2011, Merck submitted a Motion to Transfer to the JPML seeking to have all
federal cases alleging femur fractures and other bone injuries consolidated into one multidistrict
litigation for coordinated pre-trial proceedings. The Motion to Transfer would consolidate 36 existing federal cases and any future cases
filed in or removed to federal court. Oral argument on Mercks motion is scheduled for May 16, 2011.
A petition was filed seeking to coordinate all femur fracture cases filed in California state
court before a single judge in Orange County, California. It is expected that the petition will be
granted and that Judge Ronald L. Bauer will preside over the coordinated proceedings.
Additionally, there are two femur fracture cases pending in other state courts. One case is
pending in Massachusetts and one is pending in Florida. Discovery is ongoing in the federal and
state courts where femur fracture cases are pending and the Company intends to defend against these
lawsuits.
NuvaRing
Beginning in May 2007, a number of complaints were filed in various jurisdictions asserting
claims against the Companys subsidiaries Organon USA, Inc., Organon Pharmaceuticals USA, Inc.,
Organon International (collectively, Organon), and Schering-Plough arising from Organons
marketing and sale of NuvaRing, a combined hormonal contraceptive vaginal ring. The plaintiffs
contend that Organon and Schering-Plough failed to adequately warn of the alleged increased risk of
venous thromboembolism (VTE) posed by NuvaRing, and/or downplayed the risk of VTE. The plaintiffs
seek damages for injuries allegedly sustained from their product use, including some alleged
deaths, heart attacks and strokes. The majority of the cases are currently pending in a federal
multidistrict litigation (the NuvaRing MDL) venued in Missouri and in New Jersey state court.
As of March 31, 2011, there were approximately 775 NuvaRing cases. Of these cases, 650 are
pending in the NuvaRing MDL in the U.S. District Court for the Eastern District of Missouri before
Judge Rodney Sippel, and 122 are pending in consolidated discovery proceedings in the Bergen County
Superior Court of New Jersey before Judge Brian R. Martinotti. Three additional cases are pending
in various other state courts.
Pursuant to orders of Judge Sippel in the NuvaRing MDL, the parties selected 26 trial pool
cases which are the subject of fact discovery. Pursuant to Judge Martinottis order, the parties
selected an additional 10 trial pool cases that are the subject of fact discovery in the New Jersey
consolidated proceedings. Based on a revised scheduling order entered in both jurisdictions on
September 15, 2010, fact discovery in these trial pool cases will end in June 2011 and expert
discovery will end in February 2012. The first trials will then be scheduled in each jurisdiction.
The Company intends to defend against these lawsuits.
- 19 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
Commercial Litigation
AWP Litigation and Investigations
As previously disclosed, the Company and/or certain of its subsidiaries remain defendants in
cases brought by various states and certain New York counties alleging manipulation by
pharmaceutical manufacturers of Average Wholesale Prices (AWP), which are sometimes used by
public and private payors in calculating provider reimbursement levels. The outcome of these
lawsuits could include substantial damages, the imposition of substantial fines and penalties
and injunctive or administrative remedies. In January 2010, the U.S. District Court for the
District of Massachusetts held that a unit of the Company and eight other drug makers overcharged
New York City and 42 New York counties for certain generic drugs. The court has reserved the issue
of damages and any penalties for future proceedings. In a separate matter, in September 2010, a
jury in the U.S. District Court for the District of Massachusetts found the Company liable on the
ground that units of Schering-Plough caused Massachusetts to overpay pharmacists for prescriptions
of albuterol. The District Court recently held that Massachusetts should be awarded approximately
$13.8 million in treble damages and penalties, together with prejudgment interest and attorneys
fees. The Company intends to pursue a reversal of the verdict on appeal.
In the period from September 2010
through March 2011, the Company settled certain AWP cases brought by
the states of Utah, South Carolina, Alaska, Idaho, Kentucky, Pennsylvania, Mississippi, and
Wisconsin. During the same period, the Company and several other manufacturers were named
defendants in AWP cases brought by the states of Oklahoma and Louisiana. Accordingly, the Company
and/or certain of its subsidiaries continue to be defendants in cases brought by 13 states and the
New York counties.
Centocor Distribution Agreement
On May 27, 2009, Centocor, a wholly owned subsidiary of Johnson & Johnson, delivered to
Schering-Plough a notice initiating an arbitration proceeding to resolve whether, as a result of
the Merger, Centocor is permitted to terminate the Companys rights to distribute and commercialize
Remicade and Simponi. On April 15, 2011, the Company announced that it had settled the
arbitration. Under the terms of the amended distribution agreement, Mercks subsidiary,
Schering-Plough (Ireland) will relinquish exclusive marketing rights for Remicade and Simponi to
Johnson & Johnsons Janssen pharmaceutical companies in territories including Canada, Central and
South America, the Middle East, Africa and Asia Pacific (relinquished territories), effective
July 1, 2011. Merck will retain exclusive marketing rights throughout Europe, Russia and Turkey
(retained territories). The retained territories represent approximately 70% of Mercks 2010
revenue of approximately $2.8 billion from Remicade and Simponi, while the relinquished territories
represent approximately 30%. In addition, all profit derived from Mercks exclusive distribution of
the two products in the retained territories will be equally divided between Merck and Johnson &
Johnson, beginning July 1, 2011. Under the prior terms of the distribution agreement, the
contribution income (profit) split, which is currently at 58% to Merck and 42% to Centocor Ortho
Biotech Inc., would have declined for Merck and increased for Johnson & Johnson each year until
2014, when it would have been equally divided. Johnson & Johnson
also received a one-time payment from Merck of $500 million in April 2011.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file Abbreviated New Drug Applications (ANDAs) with the FDA
seeking to market generic forms of the Companys products prior to the expiration of relevant
patents owned by the Company. To protect its patent rights the Company may file patent
infringement lawsuits against such generic companies. Certain products of the Company (or marketed
via agreements with other companies) currently involved in such patent infringement litigation in
the United States include: Cancidas, Integrilin,
Nasonex, Nexium, Propecia, Temodar, Vytorin and
Zetia. Similar lawsuits defending the Companys patent rights may exist in other countries. The
Company intends to vigorously defend its patents, which it believes are valid, against infringement
by generic companies attempting to market products prior to the expiration of such patents. As
with any litigation, there can be no assurance of the outcomes, which, if adverse, could result in
significantly shortened periods of exclusivity for these products.
Cancidas In November 2009, a patent infringement lawsuit was filed in the United States
against Teva Parenteral Medicines, Inc. (TPM) in respect of TPMs application to the FDA seeking
pre-patent expiry approval to sell a generic version of Cancidas. That lawsuit has been dismissed
with no rights granted to TPM. Also, in March 2010, a patent infringement lawsuit was filed in the
United States against Sandoz Inc. (Sandoz) in respect of Sandozs application to the FDA seeking
pre-patent expiry approval to sell a generic version of Cancidas. The lawsuit automatically stays
FDA approval of Sandozs application until August 24, 2012 or until an adverse court decision, if
any, whichever may occur earlier.
Integrilin In February 2009, a patent infringement lawsuit was filed (jointly with
Millennium Pharmaceuticals, Inc. (Millennium)) in the United States against TPM in respect of
TPMs application to the FDA seeking approval to sell a generic version of Integrilin prior to the
expiry of the last to expire listed patent. As TPM did not challenge certain patents that will not
expire until November 2014, FDA approval of the TPM application cannot occur any earlier than
November 2014, however, it could be later in the event of a favorable decision in the lawsuit for
the Company and Millennium.
- 20 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
Nasonex In December 2009, a patent infringement suit was filed in the United States against
Apotex Corp. (Apotex) in respect of Apotexs application to the FDA seeking pre-patent expiry
approval to market a generic version of Nasonex. The lawsuit automatically stays FDA approval of
Apotexs ANDA until May 2012 or until an adverse court decision, if any, whichever may occur
earlier.
Nexium In November 2005, a patent infringement lawsuit was filed (jointly with AstraZeneca)
in the United States against Ranbaxy Laboratories Ltd. (Ranbaxy) in respect of Ranbaxys
application to the FDA seeking pre-patent expiry approval to sell a generic version of Nexium. As
previously disclosed, AstraZeneca, Merck and Ranbaxy entered into a settlement agreement which
provided that Ranbaxy would be entitled to bring its generic esomeprazole product to market in the
United States on May 27, 2014. The Company and AstraZeneca each
received a Civil Investigative Demand (CID) from the Federal
Trade Commission (FTC) in July
2008 regarding the settlement agreement with Ranbaxy. The Company is cooperating with the FTC in
responding to this CID. In March 2006, a patent infringement lawsuit was filed (jointly with
AstraZeneca) against IVAX Pharmaceuticals, Inc. (IVAX) (later acquired by Teva Pharmaceuticals,
Inc. (Teva)), in respect of IVAXs application to the FDA seeking pre-patent expiry approval to
sell a generic version of Nexium. In January 2010, AstraZeneca, Merck and Teva/IVAX entered into a
settlement agreement which provides that Teva/IVAX would be entitled to bring its generic
esomeprazole product to market in the United States on May 27, 2014. Patent infringement lawsuits
have also been filed in the United States against Dr. Reddys Laboratories (Dr. Reddys), Sandoz
and Lupin Ltd. (Lupin) in respect to their respective applications to the FDA seeking pre-patent
expiry approval to sell generic versions of Nexium. In
January 2011, AstraZeneca, Merck and Dr. Reddys entered into a settlement agreement which provides
that Dr. Reddys would be entitled to bring its generic esomeprazole product to market in the
United States on May 27, 2014. The lawsuits against Sandoz and Lupin are ongoing with no trial
dates presently scheduled. In February 2011, a patent infringement lawsuit was filed (jointly with
AstraZeneca) in the United States against Hamni USA, Inc.
(Hamni) in respect of Hamnis
application to the FDA seeking pre-patent expiry approval to sell a generic version of Nexium. A patent infringement lawsuit was also filed (jointly with AstraZeneca)
in February 2010 in the United States against Sun Pharma Global Fze in respect of its application to the FDA
seeking pre-patent expiry approval to sell a generic version of Nexium IV.
Propecia In December 2010, a patent infringement lawsuit was filed in the United States
against Hetero Drugs Limited (Hetero) in respect of Heteros application to the FDA seeking
pre-patent expiry approval to sell a generic version of Propecia. In March 2011, the Company
settled this lawsuit with Hetero by agreeing to allow Hetero to sell a generic 1 mg finasteride
product beginning on July 1, 2013.
Temodar In July 2007, a patent infringement action was filed (jointly with Cancer Research
Technologies, Limited (CRT)) in the United States against
Barr Laboratories (Barr) (later acquired by Teva) in respect
of Barrs application to the FDA seeking pre-patent expiry approval to sell a generic version of
Temodar. In January 2010, the court issued a decision finding the CRT patent unenforceable on
grounds of prosecution laches and inequitable conduct. In November 2010, the appeals court issued a
decision reversing the trial courts finding. In December 2010, Barr filed a petition seeking a
rehearing en banc of the appeal, which petition was denied. By virtue of an agreement that Barr
not launch a product during the appeal process, the Company has agreed that Barr can launch a
product in August 2013.
In September 2010, a patent infringement lawsuit was filed (jointly with CRT) in the United
States against Sun Pharmaceutical Industries Inc. (Sun) in respect of Suns application to the
FDA seeking pre-patent expiry approval to sell a generic version of Temodar. The lawsuit
automatically stays FDA approval of Suns ANDA until February 2013 or until an adverse court
decision, if any, whichever may occur earlier. In November 2010, a patent infringement lawsuit was
filed (jointly with CRT) in the United States against Accord HealthCare Inc. (Accord) in respect of its
application to the FDA seeking pre-patent expiry approval to sell a generic version of Temodar.
The Company, CRT and Accord have entered an agreement to stay the lawsuit pending the outcome of
the appeal en banc process in the Barr lawsuit.
Vytorin In December 2009, a patent infringement lawsuit was filed in the United States
against Mylan Pharmaceuticals, Inc. (Mylan) in respect of Mylans application to the FDA seeking pre-patent expiry approval to
sell a generic version of Vytorin. The lawsuit automatically stays FDA approval of Mylans
application until May 2012 or until an adverse court decision,
if any, whichever may occur earlier.
In February 2010, a patent infringement lawsuit was filed in the United States against Teva in
respect of Tevas application to the FDA seeking pre-patent expiry approval to sell a generic
version of Vytorin. The lawsuit automatically stays FDA approval of Tevas application until
August 2013 or until an adverse court decision, if any, whichever may occur earlier. In August
2010, a patent infringement lawsuit was filed in the United States against Impax Laboratories Inc.
(Impax) in respect of Impaxs application to the FDA seeking pre-patent expiry approval to sell a
generic version of Vytorin. An agreement was reached with Impax to stay the lawsuit pending the
outcome of the lawsuit with Mylan.
- 21 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
Zetia In March 2007, a patent infringement lawsuit was filed in the United States against
Glenmark Pharmaceuticals Inc., USA and its parent corporation (collectively, Glenmark) in respect
of Glenmarks application to the FDA seeking pre-patent expiry approval to sell a generic version
of Zetia. In May 2010, Glenmark agreed to a settlement by virtue of which Glenmark will be
permitted to launch its generic product in the United States on December 12, 2016, subject to
receiving final FDA approval. In June 2010, a patent infringement lawsuit was filed in the United
States against Mylan in respect of Mylans application to the FDA seeking pre-patent expiry
approval to sell a generic version of Zetia. The lawsuit automatically stays FDA approval of
Mylans application until December 2012 or until an adverse court decision, if any, whichever may
occur earlier. In September 2010, a patent infringement lawsuit was filed in the United States
against Teva in respect of Tevas application to the FDA seeking pre-patent expiry approval to sell
a generic version of Zetia. The lawsuit automatically stays FDA approval of Tevas application
until January 2013 or until an adverse court decision, if any, whichever may occur earlier.
In September 2008, a lawsuit was filed in the Federal Court of Canada against Teva seeking an
order of prohibition of Tevas application seeking pre-patent expiry approval to sell a generic
version of Ezetrol (marketed in the United States as Zetia) in Canada. Teva responded asserting that the patent was invalid. In September
2010, the Federal Court of Canada issued a decision upholding the validity of the Companys
Canadian Ezetrol patent. This decision was not appealed. In August 2010, a lawsuit was filed in
the Federal Court of Canada against Mylan seeking an order of prohibition of Mylans application
seeking pre-patent expiry approval to sell a generic version of Ezetrol in Canada. In December
2010, Mylan withdrew its application for product approval prior to patent expiration in September
2014 and the subject lawsuit was withdrawn.
Environmental Matters
As previously disclosed, approximately 2,200 plaintiffs have filed an amended complaint
against Old Merck and 12 other defendants in U.S. District Court, Eastern District of California
asserting claims under the Clean Water Act, the Resource Conservation and Recovery Act, as well as
negligence and nuisance. The suit seeks damages for personal injury, diminution of property value,
medical monitoring and other alleged real and personal property damage associated with groundwater
and soil contamination found at the site of a former Old Merck subsidiary in Merced, California.
Certain of the other defendants in this suit have settled with plaintiffs regarding some or all
aspects of plaintiffs claims. This lawsuit is proceeding in a phased manner. A jury trial
commenced in February 2011 during which a jury was asked to make certain factual findings
regarding whether contamination moved off-site to any areas where plaintiffs could have been
exposed to such contamination and, if so, when, where and in what amounts. Defendants in this
Phase 1 trial include Old Merck and three of the other original 12 defendants. On March 31,
2011, the Phase 1 jury returned a mixed verdict, finding in favor of Old Merck and the other
defendants as to some, but not all, of plaintiffs claims. Specifically, the jury found that
contamination from the site did not enter or affect plaintiffs municipal water supply wells or any
private domestic wells. The jury found, however, that plaintiffs could have been exposed to
contamination via air emissions prior to 1994, as well as via surface water in the form of storm
drainage channeled into an adjacent irrigation canal, including during a flood in April 2006. Old
Merck will file motions requesting that the court set aside those portions of the jurys verdict
that are adverse to Old Merck on the basis that those portions of the verdict are unsupported by
the evidence and contrary to established legal principles. If necessary, Old Merck will seek to
appeal, prior to commencement of any later phases of the litigation, those portions of the jurys
verdict adverse to Old Merck that are not set aside by the trial court. In the event the Phase 1
jurys findings in favor of plaintiffs are not set aside by the trial court or on appeal, it is
anticipated that later phases of the litigation would be required to address issues related to
liability, causation and damages related to specific plaintiffs.
Other Litigation
There are various other legal proceedings, principally product liability and intellectual
property suits involving the Company, that are pending. While it is not feasible to predict the
outcome of such proceedings or the proceedings discussed in this Note, in the opinion of the
Company, all such proceedings should not ultimately result in any liability that would have a material adverse effect on the
financial position, liquidity or results of operations of the Company, other than proceedings for
which a separate assessment is provided in this Note.
- 22 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
10. Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Non- |
|
|
|
|
|
|
Common Stock |
|
|
Paid-In |
|
|
Retained |
|
|
Comprehensive |
|
|
Treasury Stock |
|
|
Controlling |
|
|
|
|
($ in millions) |
|
Shares |
|
|
Par Value |
|
|
Capital |
|
|
Earnings |
|
|
Loss |
|
|
Shares |
|
|
Cost |
|
|
Interests |
|
|
Total |
|
|
Balance January 1, 2010 |
|
|
3,563 |
|
|
$ |
1,781 |
|
|
$ |
39,683 |
|
|
$ |
41,405 |
|
|
$ |
(2,767 |
) |
|
|
454 |
|
|
$ |
(21,044 |
) |
|
$ |
2,427 |
|
|
$ |
61,485 |
|
Net income
attributable to Merck & Co., Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
299 |
|
Cash dividends declared on
common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,193 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,193 |
) |
Share-based compensation
plans and other |
|
|
9 |
|
|
|
5 |
|
|
|
514 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
519 |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(805 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(805 |
) |
Net income attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 |
|
|
|
31 |
|
Distributions attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
|
|
(1 |
) |
|
Balance March 31, 2010 |
|
|
3,572 |
|
|
$ |
1,786 |
|
|
$ |
40,197 |
|
|
$ |
40,511 |
|
|
$ |
(3,572 |
) |
|
|
454 |
|
|
$ |
(21,044 |
) |
|
$ |
2,457 |
|
|
$ |
60,335 |
|
|
Balance January 1, 2011 |
|
|
3,577 |
|
|
$ |
1,788 |
|
|
$ |
40,701 |
|
|
$ |
37,536 |
|
|
$ |
(3,216 |
) |
|
|
495 |
|
|
$ |
(22,433 |
) |
|
$ |
2,429 |
|
|
$ |
56,805 |
|
|
Net income
attributable to Merck & Co., Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,043 |
|
Cash dividends declared on
common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,179 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,179 |
) |
Share-based compensation
plans and other |
|
|
|
|
|
|
|
|
|
|
(11 |
) |
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
109 |
|
|
|
|
|
|
|
98 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46 |
|
Net income attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28 |
|
|
|
28 |
|
Distributions attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
|
(2 |
) |
|
Balance March 31, 2011 |
|
|
3,577 |
|
|
$ |
1,788 |
|
|
$ |
40,690 |
|
|
$ |
37,400 |
|
|
$ |
(3,170 |
) |
|
|
492 |
|
|
$ |
(22,324 |
) |
|
$ |
2,455 |
|
|
$ |
56,839 |
|
|
In connection with the 1998 restructuring of Astra Merck Inc., the Company assumed $2.4
billion par value preferred stock with a dividend rate of 5% per annum, which is carried by KBI and
included in Noncontrolling interests on the Consolidated Balance Sheet. If AstraZeneca exercises
the Shares Option (see Note 8) this preferred stock obligation will be settled.
The accumulated balances related to each component of other comprehensive income (loss), net
of taxes, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
|
Cumulative |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
Benefit |
|
|
Translation |
|
|
Comprehensive |
|
($ in millions) |
|
Derivatives |
|
|
Investments |
|
|
Plans |
|
|
Adjustment |
|
|
Income (Loss) |
|
|
Balance January 1, 2010 |
|
$ |
(42 |
) |
|
$ |
33 |
|
|
$ |
(2,469 |
) |
|
$ |
(289 |
) |
|
$ |
(2,767 |
) |
Other
comprehensive income (loss) |
|
|
68 |
|
|
|
(6 |
) |
|
|
59 |
|
|
|
(926 |
) |
|
|
(805 |
) |
|
Balance at March 31, 2010 |
|
$ |
26 |
|
|
$ |
27 |
|
|
$ |
(2,410 |
) |
|
$ |
(1,215 |
) |
|
$ |
(3,572 |
) |
|
Balance January 1, 2011 |
|
$ |
41 |
|
|
$ |
31 |
|
|
$ |
(2,043 |
) |
|
$ |
(1,245 |
) |
|
$ |
(3,216 |
) |
Other comprehensive income (loss) |
|
|
(107 |
) |
|
|
(1 |
) |
|
|
18 |
|
|
|
136 |
|
|
|
46 |
|
|
Balance at March 31, 2011 |
|
$ |
(66 |
) |
|
$ |
30 |
|
|
$ |
(2,025 |
) |
|
$ |
(1,109 |
) |
|
$ |
(3,170 |
) |
|
Comprehensive income (loss) was $1.1 billion and $(506) million for the three months ended
March 31, 2011 and 2010, respectively.
Included in the cumulative translation adjustment are pretax (losses) gains of $(149) million
and $234 million for the first quarter of 2011 and 2010, respectively, from euro-denominated notes
which have been designated as, and are effective as, economic hedges of the net investment in a
foreign operation.
- 23 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
11. Share-Based Compensation Plans
The Company has share-based compensation plans under which employees and non-employee directors
may be granted restricted stock units (RSUs). In addition,
the Company grants options to purchase shares of Company common stock at the fair market value at the time of grant and performance share units (PSUs) to certain management-level employees. The Company recognizes the fair value of
share-based compensation in net income on a straight-line basis over the requisite service period.
The following table provides amounts of share-based compensation cost recorded in the
Consolidated Statement of Income:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Pretax share-based compensation expense |
|
$ |
93 |
|
|
$ |
132 |
|
Income tax benefit |
|
|
(32 |
) |
|
|
(45 |
) |
|
Total share-based compensation expense, net of taxes |
|
$ |
61 |
|
|
$ |
87 |
|
|
During the first three months of 2011 and 2010, the Company granted 221 thousand RSUs with a
weighted-average grant price of $33.27 per RSU and 1.0 million RSUs with a weighted-average grant
price of $37.49 per RSU, respectively.
During the first three months of 2011 and 2010, the Company granted 25 thousand options with a
weighted-average grant price of $33.27 per option and 1.3 million options with a weighted-average
grant price of $37.49 per option, respectively.
The weighted average fair value of options granted
for the first three months of 2011 and 2010 was $5.96 and $6.68 per option, respectively, and was
determined using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
|
Expected dividend yield |
|
|
4.2 |
% |
|
|
4.1 |
% |
Risk-free interest rate |
|
|
3.1 |
% |
|
|
2.7 |
% |
Expected volatility |
|
|
26.0 |
% |
|
|
26.8 |
% |
Expected life (years) |
|
|
7.0 |
|
|
|
6.0 |
|
|
At March 31, 2011, there was $649 million of total pretax unrecognized compensation expense
related to nonvested stock options, RSU and PSU awards which will be recognized over a weighted
average period of 2.3 years. For segment reporting, share-based compensation costs are unallocated
expenses.
12. Pension and Other Postretirement Benefit Plans
The Company has defined benefit pension plans covering eligible employees in the United States
and in certain of its international subsidiaries. The net cost of such plans consisted of the
following components:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Service cost |
|
$ |
152 |
|
|
$ |
154 |
|
Interest cost |
|
|
179 |
|
|
|
177 |
|
Expected return on plan assets |
|
|
(243 |
) |
|
|
(217 |
) |
Net amortization |
|
|
45 |
|
|
|
45 |
|
Termination benefits |
|
|
10 |
|
|
|
19 |
|
Curtailments |
|
|
(4 |
) |
|
|
(36 |
) |
Settlements |
|
|
(1 |
) |
|
|
(1 |
) |
|
|
|
$ |
138 |
|
|
$ |
141 |
|
|
- 24 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
The Company provides medical, dental and life insurance benefits, principally to its eligible
U.S. retirees and similar benefits to their dependents, through its other postretirement benefit
plans. The net cost of such plans consisted of the following components:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Service cost |
|
$ |
28 |
|
|
$ |
26 |
|
Interest cost |
|
|
36 |
|
|
|
38 |
|
Expected return on plan assets |
|
|
(35 |
) |
|
|
(32 |
) |
Net amortization |
|
|
(3 |
) |
|
|
2 |
|
Termination benefits |
|
|
2 |
|
|
|
20 |
|
Curtailments |
|
|
1 |
|
|
|
|
|
|
|
|
$ |
29 |
|
|
$ |
54 |
|
|
In connection with restructuring actions (see Note 2), termination charges for the three
months ended March 31, 2011 and 2010 were recorded on pension and other postretirement benefit
plans related to expanded eligibility for certain employees exiting Merck. Also, in connection
with these restructuring actions, curtailments were recorded on pension and other postretirement
benefit plans and settlements were recorded on pension plans as reflected in the tables above.
13. Other (Income) Expense, Net
Other (income) expense, net, consisted of:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Interest income |
|
$ |
(41 |
) |
|
$ |
(12 |
) |
Interest expense |
|
|
186 |
|
|
|
181 |
|
Exchange losses |
|
|
42 |
|
|
|
80 |
|
Other, net |
|
|
435 |
|
|
|
(82 |
) |
|
|
|
$ |
622 |
|
|
$ |
167 |
|
|
Other, net (as presented in the table above) for the first quarter of 2011 reflects a $500
million charge related to the resolution of the arbitration proceeding involving the Companys
rights to market Remicade and Simponi (see Note 9 to the interim consolidated financial
statements), as well as a $134 million gain on the sale of certain manufacturing facilities and related
assets. Other, net for the first quarter of 2010 reflects $102 million of income recognized on the
settlement of certain disputed royalties. Exchange losses for the first quarter of 2011 declined
as compared with the first quarter of 2010 primarily driven by a Venezuelan currency devaluation in
the first quarter of 2010 resulting in the recognition of $80 million of exchange losses.
Effective January 11, 2010, the Venezuelan government devalued its currency from at BsF 2.15 per
U.S. dollar to a two-tiered official exchange rate at (1) the essentials rate at BsF 2.60 per
U.S. dollar and (2) the non-essentials rate at BsF 4.30
per U.S. dollar. In January 2010, the Company was
required to remeasure its local currency operations in Venezuela to U.S. dollars as the Venezuelan
economy was determined to be hyperinflationary. Throughout 2010, the Company settled its
transactions at the essentials rate and therefore remeasured monetary assets and liabilities using
the essentials rate. In December 2010, the Venezuelan government
announced it would eliminate the essentials rate and effective
January 1, 2011, all transactions would be settled at the official
rate of at BsF 4.30 per U.S. dollar. As a result of this
announcement, the Company remeasured its December 31, 2010 monetary
assets and liabilities at the new official rate. Interest paid for the three months ended March 31, 2011 and 2010 was $144
million and $129 million, respectively, which excludes commitment fees.
- 25 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
14. Taxes on Income
The effective tax rate of 38.1% for the first quarter of 2011 reflects the impacts of purchase
accounting adjustments, restructuring costs and the $500 million charge related to the resolution of
the arbitration proceeding with Johnson & Johnson, which
collectively had a 24% unfavorable impact as compared with the
statutory rate. The effective tax rate was also affected by the
beneficial impact of foreign earnings. The effective tax rate of 46.4% for the first
quarter of 2010 reflects the impact of a $147 million charge associated with a change in tax law
that requires taxation of the prescription drug subsidy of the Companys retiree health benefit
plans which was enacted in the first quarter of 2010 as part of U.S. health care reform
legislation, as well as the impacts of purchase accounting adjustments and restructuring charges.
The Company and Old Merck are both under examination by numerous tax authorities in various
jurisdictions globally.
In 2010, the Internal Revenue Service (IRS) finalized its examination of Schering-Ploughs 2003-2006 tax years. In this
audit cycle, the Company reached an agreement with the IRS on an adjustment to income related to
intercompany pricing matters. This income adjustment mostly reduced net operating losses (NOLs)
and other tax credit carryforwards. Additionally, the Company is seeking resolution of one issue
raised during this examination through the IRS administrative appeals process. The Companys
reserves for uncertain tax positions were adequate to cover all adjustments related to this
examination period. The IRS began its examination of the 2007-2009 tax years for the Company in
2010.
As previously disclosed, the Company believes that it is reasonably possible that the total amount
of unrecognized tax benefits as of December 31, 2010 could decrease by up to $2.0 billion in 2011 for both the Company and Old Merck as a result of various audit closures, including the IRS audit discussed below, settlements or
the expiration of the statute of limitations. The ultimate finalization of the Companys
examinations with relevant taxing authorities can include formal administrative and legal
proceedings, which could have a significant impact on the timing of the reversal of unrecognized
tax benefits. The Company believes that its reserves for uncertain tax positions are adequate to
cover any risks or exposures.
In April 2011, the IRS concluded its examination of Old Mercks 2002-2005 federal income tax
returns and as a result the Company was required to make net payments
of approximately $465
million. The Companys unrecognized tax benefits for the years under examination exceed the adjustments related to
this examination period and therefore the Company anticipates that a potentially significant
non-cash favorable financial statement impact from this resolution will be recorded in the second
quarter. The Company disagrees with the IRS treatment of one issue raised during this examination
and is appealing the matter through the IRS administrative process.
As previously disclosed, the Canada Revenue Agency (CRA) has proposed adjustments for 1999
and 2000 relating to intercompany pricing matters. The adjustments would increase Canadian tax due
by approximately $325 million (U.S. dollars) plus approximately $360 million (U.S. dollars) of
interest through March 31, 2011. The Company disagrees with the positions taken by the CRA and
believes they are without merit. The Company continues to contest the assessments through the CRA
appeals process. The CRA is expected to prepare similar adjustments for later years. Management
believes that resolution of these matters will not have a material effect on the Companys
financial position or liquidity.
In October 2001, IRS auditors asserted that two interest rate
swaps that Schering-Plough entered into with an unrelated party should be re-characterized as loans
from affiliated companies, resulting in additional tax liability for the 1991 and 1992 tax years.
In September 2004, Schering-Plough made payments to the IRS in the amount of $194 million for
income taxes and $279 million for interest. The Companys tax reserves were adequate to cover
these payments. Schering-Plough filed refund claims for the taxes and interest with the IRS in
December 2004. Following the IRSs denial of Schering-Ploughs claims for a refund,
Schering-Plough filed suit in May 2005 in the U.S. District Court for the District of New Jersey
for refund of the full amount of taxes and interest. A decision in favor of the government was
announced in August 2009. The Companys appeal of the decision was heard by the U.S. Court of
Appeals for the Third Circuit on March 24, 2011. The Company is awaiting a decision on the appeal.
- 26 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
15. Earnings Per Share
The Company calculates earnings per share pursuant to the two-class method, which is an
earnings allocation formula that determines earnings per share for common stock and participating
securities according to dividends declared and participation rights in undistributed earnings.
Under this method, all earnings (distributed and undistributed) are allocated to common shares and
participating securities based on their respective rights to receive dividends. RSUs and certain
PSUs granted before December 31, 2009 to certain management level employees participate in
dividends on the same basis as common shares and such dividends are nonforfeitable by the holder.
As a result, these RSUs and PSUs meet the definition of a participating security. For RSUs and
PSUs issued on or after January 1, 2010, dividends declared during the vesting period are payable
to the employees only upon vesting and therefore such RSUs and PSUs do not meet the definition of a
participating security.
The calculations of earnings per share under the two-class method are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
|
Basic Earnings per Common Share |
|
|
|
|
|
|
|
|
Net income attributable to Merck & Co., Inc.
common shareholders |
|
$ |
1,043 |
|
|
$ |
299 |
|
Less: Income allocated to participating securities |
|
|
3 |
|
|
|
1 |
|
|
Net income allocated to common shareholders |
|
$ |
1,040 |
|
|
$ |
298 |
|
|
Average common shares outstanding |
|
|
3,084 |
|
|
|
3,114 |
|
|
|
|
$ |
0.34 |
|
|
$ |
0.10 |
|
|
Earnings per Common Share Assuming Dilution |
|
|
|
|
|
|
|
|
Net income attributable to Merck & Co., Inc.
common shareholders |
|
$ |
1,043 |
|
|
$ |
299 |
|
Less: Income allocated to participating securities |
|
|
3 |
|
|
|
1 |
|
|
Net income allocated to common shareholders |
|
$ |
1,040 |
|
|
$ |
298 |
|
|
Average common shares outstanding |
|
|
3,084 |
|
|
|
3,114 |
|
Common shares issuable (1) |
|
|
20 |
|
|
|
27 |
|
|
Average common shares outstanding assuming dilution |
|
|
3,104 |
|
|
|
3,141 |
|
|
|
|
$ |
0.34 |
|
|
$ |
0.09 |
|
|
|
|
|
(1) |
|
Issuable primarily under share-based compensation plans. |
For the three months ended March 31, 2011 and 2010, 185 million and 182 million,
respectively, of common shares issuable under share-based compensation plans were excluded from the
computation of earnings per common share assuming dilution because the effect would have been
antidilutive.
- 27 -
Notes to Consolidated Financial Statements (unaudited) (continued)
16. Segment Reporting
The Companys operations are principally managed on a products basis and are comprised of four
operating segments Pharmaceutical, Animal Health, Consumer Care and Alliances (which includes
revenue and equity income from the Companys relationship with AZLP). The Animal Health, Consumer
Care and Alliances segments are not material for separate reporting and are included in all other
in the table below. The Pharmaceutical segment includes human health pharmaceutical and vaccine
products marketed either directly by the Company or through joint ventures. Human health
pharmaceutical products consist of therapeutic and preventive agents, generally sold by
prescription, for the treatment of human disorders. The Company sells these human health
pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies
and managed health care providers such as health maintenance organizations, pharmacy benefit
managers and other institutions. Vaccine products consist of preventive pediatric, adolescent and
adult vaccines, primarily administered at physician offices. The Company sells these human health
vaccines primarily to physicians, wholesalers, physician distributors and government entities. A
large component of pediatric and adolescent vaccines is sold to the U.S. Centers for Disease
Control and Prevention Vaccines for Children program, which is funded
by the U.S. government. Additionally, the Company sells vaccines to
the Federal government for placement into vaccine stockpiles. The
Company also has animal health operations that discover, develop, manufacture and market animal
health products, including vaccines, which the Company sells to veterinarians, distributors and
animal producers. Additionally, the Company has consumer care operations that develop, manufacture
and market over-the-counter, foot care and sun care products, which are sold through wholesale and
retail drug, food chain and mass merchandiser outlets. Segment composition reflects certain
managerial changes that have been implemented. Consumer Care product sales outside the United
States and Canada, previously included in the Pharmaceutical segment, are now included in the
Consumer Care segment. Segment disclosures for prior periods have been recast on a comparable
basis with 2011.
Revenues and profits for these segments are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Segment revenues: |
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
9,820 |
|
|
$ |
9,665 |
|
All other segment revenues |
|
|
1,609 |
|
|
|
1,570 |
|
|
|
|
$ |
11,429 |
|
|
$ |
11,235 |
|
|
|
|
|
|
|
|
|
|
|
Segment profits: |
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
6,216 |
|
|
$ |
5,740 |
|
All other segment profits |
|
|
716 |
|
|
|
720 |
|
|
|
|
$ |
6,932 |
|
|
$ |
6,460 |
|
|
Segment profits are comprised of segment revenues less certain elements of materials and
production costs and operating expenses, including components of equity income or loss from
affiliates and depreciation and amortization expenses. For internal management reporting presented
to the chief operating decision maker, Merck does not allocate production costs, other than
standard costs, research and development expenses or general and administrative expenses, nor the
cost of financing these activities. Separate divisions maintain responsibility for monitoring and
managing these costs, including depreciation related to fixed assets utilized by these divisions
and, therefore, they are not included in segment profits.
- 28 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Sales of the Companys products were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
Cardiovascular |
|
|
|
|
|
|
|
|
Zetia |
|
$ |
582 |
|
|
$ |
534 |
|
Vytorin |
|
|
480 |
|
|
|
477 |
|
Integrilin |
|
|
64 |
|
|
|
70 |
|
|
|
|
|
|
|
|
|
|
Diabetes and Obesity |
|
|
|
|
|
|
|
|
Januvia |
|
|
739 |
|
|
|
511 |
|
Janumet |
|
|
305 |
|
|
|
201 |
|
|
|
|
|
|
|
|
|
|
Diversified Brands |
|
|
|
|
|
|
|
|
Cozaar/Hyzaar |
|
|
426 |
|
|
|
782 |
|
Zocor |
|
|
127 |
|
|
|
116 |
|
Claritin Rx |
|
|
120 |
|
|
|
98 |
|
Propecia |
|
|
106 |
|
|
|
100 |
|
Proscar |
|
|
60 |
|
|
|
58 |
|
Remeron |
|
|
60 |
|
|
|
51 |
|
Vasotec/Vaseretic |
|
|
57 |
|
|
|
59 |
|
|
|
|
|
|
|
|
|
|
Infectious Disease |
|
|
|
|
|
|
|
|
Isentress |
|
|
292 |
|
|
|
232 |
|
PegIntron |
|
|
166 |
|
|
|
186 |
|
Cancidas |
|
|
158 |
|
|
|
153 |
|
Primaxin |
|
|
136 |
|
|
|
159 |
|
Avelox |
|
|
106 |
|
|
|
106 |
|
Invanz |
|
|
87 |
|
|
|
75 |
|
Noxafil |
|
|
55 |
|
|
|
49 |
|
Rebetol |
|
|
53 |
|
|
|
56 |
|
Crixivan/Stocrin |
|
|
45 |
|
|
|
52 |
|
|
|
|
|
|
|
|
|
|
Neurosciences and Ophthalmology |
|
|
|
|
|
|
|
|
Maxalt |
|
|
173 |
|
|
|
135 |
|
Cosopt/Trusopt |
|
|
114 |
|
|
|
115 |
|
|
|
|
|
|
|
|
|
|
Oncology |
|
|
|
|
|
|
|
|
Temodar |
|
|
248 |
|
|
|
274 |
|
Emend |
|
|
87 |
|
|
|
84 |
|
Intron A |
|
|
49 |
|
|
|
54 |
|
|
|
|
|
|
|
|
|
|
Respiratory and Immunology |
|
|
|
|
|
|
|
|
Singulair |
|
|
1,328 |
|
|
|
1,165 |
|
Remicade |
|
|
753 |
|
|
|
674 |
|
Nasonex |
|
|
373 |
|
|
|
320 |
|
Clarinex |
|
|
155 |
|
|
|
164 |
|
Arcoxia |
|
|
114 |
|
|
|
95 |
|
Asmanex |
|
|
60 |
|
|
|
51 |
|
Simponi |
|
|
54 |
|
|
|
10 |
|
Proventil |
|
|
42 |
|
|
|
57 |
|
Dulera |
|
|
13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaccines (1) |
|
|
|
|
|
|
|
|
ProQuad/M-M-R II/Varivax |
|
|
244 |
|
|
|
319 |
|
Gardasil |
|
|
214 |
|
|
|
233 |
|
RotaTeq |
|
|
125 |
|
|
|
93 |
|
Pneumovax |
|
|
79 |
|
|
|
51 |
|
Zostavax |
|
|
24 |
|
|
|
95 |
|
|
|
|
|
|
|
|
|
|
Womens Health and Endocrine |
|
|
|
|
|
|
|
|
Fosamax |
|
|
208 |
|
|
|
230 |
|
NuvaRing |
|
|
142 |
|
|
|
135 |
|
Follistim AQ |
|
|
133 |
|
|
|
134 |
|
Implanon |
|
|
60 |
|
|
|
51 |
|
Cerazette |
|
|
59 |
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
Other pharmaceutical (2) |
|
|
745 |
|
|
|
946 |
|
|
Total Pharmaceutical segment sales |
|
|
9,820 |
|
|
|
9,665 |
|
|
Other segment sales (3) |
|
|
1,609 |
|
|
|
1,570 |
|
|
Total segment sales |
|
|
11,429 |
|
|
|
11,235 |
|
|
Other (4) |
|
|
151 |
|
|
|
187 |
|
|
|
|
$ |
11,580 |
|
|
$ |
11,422 |
|
|
|
|
|
(1) |
|
These amounts do not reflect sales of vaccines sold in most major European
markets through the Companys joint venture, Sanofi Pasteur MSD, the results of which are
reflected in Equity income from affiliates. These amounts do, however, reflect supply sales
to Sanofi Pasteur MSD. |
|
(2) |
|
Other pharmaceutical primarily includes sales of other human pharmaceutical
products, including products within the franchises not listed separately. |
|
(3) |
|
Reflects other non-reportable segments, including Animal Health and Consumer Care,
and revenue from the Companys relationship with AZLP primarily relating to sales of Nexium,
as well as Prilosec. Revenue from AZLP was $322 million and $364 million for the first
quarter of 2011 and 2010, respectively. |
|
(4) |
|
Other revenues are primarily comprised of miscellaneous corporate revenues,
third-party manufacturing sales, sales related to divested products or businesses and other
supply sales not included in segment results. |
- 29 -
Notes to Consolidated Financial Statements (unaudited) (continued)
A reconciliation of segment profits to Income before taxes is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Segment profits |
|
$ |
6,932 |
|
|
$ |
6,460 |
|
Other profits (losses) |
|
|
(23 |
) |
|
|
12 |
|
Adjustments |
|
|
219 |
|
|
|
124 |
|
Unallocated: |
|
|
|
|
|
|
|
|
Interest income |
|
|
41 |
|
|
|
12 |
|
Interest expense |
|
|
(186 |
) |
|
|
(181 |
) |
Equity income from affiliates |
|
|
54 |
|
|
|
47 |
|
Depreciation and amortization |
|
|
(572 |
) |
|
|
(500 |
) |
Research and development |
|
|
(2,158 |
) |
|
|
(2,051 |
) |
Amortization of purchase
accounting adjustments |
|
|
(1,580 |
) |
|
|
(2,374 |
) |
Restructuring costs |
|
|
14 |
|
|
|
(288 |
) |
Arbitration settlement charge |
|
|
(500 |
) |
|
|
|
|
Other expenses, net |
|
|
(512 |
) |
|
|
(645 |
) |
|
|
|
$ |
1,729 |
|
|
$ |
616 |
|
|
Other profits (losses) are primarily comprised of miscellaneous corporate profits (losses), as
well as operating profits (losses) related to third-party manufacturing sales, divested products or
businesses and other supply sales. Adjustments represent the elimination of the effect of double
counting certain items of income and expense. Equity income from affiliates includes taxes paid at
the joint venture level and a portion of equity income that is not reported in segment profits.
Other expenses, net include expenses from corporate and manufacturing cost centers and other
miscellaneous income (expense), net.
- 30 -
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
Merger
On November 3, 2009, Merck & Co., Inc. (Old Merck) and Schering-Plough Corporation
(Schering-Plough) completed their previously-announced merger (the Merger). In the Merger,
Schering-Plough acquired all of the shares of Old Merck, which became a wholly-owned subsidiary of
Schering-Plough and was renamed Merck Sharp & Dohme Corp. Schering-Plough continued as the
surviving public company and was renamed Merck & Co., Inc. (New Merck or the Company).
However, for accounting purposes only, the Merger was treated as an acquisition with Old Merck
considered the accounting acquirer. Accordingly, the accompanying financial statements reflect Old
Mercks stand-alone operations as they existed prior to the completion of the Merger. References in this report and in the
accompanying financial statements to Merck for periods prior to the Merger refer to Old Merck and
for periods after the completion of the Merger to New Merck.
Arbitration Settlement
In April 2011, Merck and Johnson & Johnson reached agreement to amend the distribution rights
to Remicade and Simponi. This agreement concluded the arbitration proceeding Johnson & Johnson
initiated in May 2009, requesting a ruling related to the distribution agreement following the
announcement of the proposed merger between Merck and Schering-Plough. Under the terms of the
amended distribution agreement, Merck will relinquish exclusive marketing rights for Remicade and
Simponi to Johnson & Johnson in territories including Canada, Central and South America, the Middle
East, Africa and Asia Pacific effective July 1, 2011. Merck will retain exclusive marketing rights
throughout Europe, Russia and Turkey (retained territories). The retained territories represent
approximately 70% of Mercks 2010 revenue of approximately $2.8 billion from Remicade and Simponi.
In addition, all profit derived from Mercks exclusive distribution of the two products in the
retained territories will be equally divided between Merck and Johnson & Johnson, beginning July 1,
2011. Under the prior terms of the distribution agreement, the contribution income (profit) split,
which is currently at 58% to Merck and 42% percent to Johnson & Johnson, would have declined for
Merck and increased for Johnson & Johnson each year until 2014, when it would have been equally
divided. Johnson & Johnson also received a one-time payment from Merck of $500 million in April 2011.
U.S. Health Care Reform Legislation
In 2010, the United States enacted major health care reform legislation. Various insurance
market reforms began last year and will continue through full implementation in 2014. The new law
is expected to expand access to health care to more than 32 million Americans by the end of the
decade that did not previously have regular access to health care.
With respect to the effect of the law on the pharmaceutical industry, beginning in 2010, the
law increased the mandated Medicaid rebate from 15.1% to 23.1%, expanded the rebate to Medicaid
managed care utilization, and increased the types of entities eligible for the federal 340B drug
discount program. The implementation of these provisions reduced
revenues by approximately $40
million and $33 million in the first quarter of 2011 and 2010, respectively.
Effective in 2011, the law also requires pharmaceutical manufacturers to pay a 50% discount on
Medicare Part D utilization by beneficiaries when they are in the Medicare Part D coverage gap
(i.e., the so-called donut hole). Approximately $34 million was recorded as a reduction to
revenue in the first quarter of 2011 related to the estimated impact
of this provision of health care reform.
Also, beginning in 2011, pharmaceutical manufacturers will be required to pay an annual health
care reform fee. The total annual industry fee, which will be $2.5 billion in 2011, will be
assessed on each company in proportion to its share of sales to certain government programs, such
as Medicare and Medicaid. The Companys portion of the annual fee is payable no later than
September 30 of the applicable calendar year and is not tax deductible. The liability related to
the annual fee for 2011 was estimated by the Company to be $167 million and was recorded in full
during the first quarter of 2011 with a corresponding offset to a deferred asset. The deferred
asset is being amortized to Marketing and administrative expense during 2011 on a straight-line
basis, therefore $42 million of expense was recognized in the first quarter.
- 31 -
Acquisition
In April 2011, Merck entered into a definitive agreement under which Merck will acquire
Inspire Pharmaceuticals, Inc. (Inspire), a specialty pharmaceutical company focused on developing
and commercializing ophthalmic products. Under the terms of the agreement, Merck commenced a
tender offer for all outstanding common stock of Inspire at a price of $5.00 per share in cash.
The transaction has a total cash value of approximately $430 million. The transaction has been
unanimously approved by the boards of directors of both companies and Inspires board recommended
that the companys shareholders tender their shares pursuant to the tender offer. In addition,
Warburg Pincus Private Equity IX, L.P., which owns approximately 28% of the outstanding shares of
Inspire, has agreed to tender all of its shares into the offer. The closing of the tender offer
will be subject to certain conditions, including the tender of a number of Inspire shares that,
together with shares owned by Merck, represent at least a majority of the total number of Inspires
outstanding shares (assuming the exercise of all options and vesting of restricted stock units),
and customary closing conditions. Upon the completion of the tender offer, Merck will acquire all
remaining shares of Inspire through a second-step merger. The Company anticipates the transaction will close
in the second quarter of 2011.
Operating Results
Segment composition reflects certain managerial changes that have been implemented. Consumer
Care product sales outside the United States and Canada, previously included in the Pharmaceutical
segment, are now included in the Consumer Care segment. Segment disclosures for prior periods have
been recast on a comparable basis with 2011.
Sales
Worldwide sales were $11.6 billion for the first quarter of 2011, an increase of 1% compared
with the first quarter of 2010. The revenue increase largely reflects higher sales of Januvia and
Janumet, Singulair, Remicade, Isentress, Nasonex, Zetia, and Simponi, as well as growth in sales of
the Companys animal health and consumer care products. These increases were partially offset by
lower sales of Cozaar* and Hyzaar* which lost patent protection in the United States in April 2010
and in a number of major European markets in March 2010. Revenue was also negatively affected by
lower sales of Varivax, Zostavax, and the products Caelyx and Subutex/Suboxone for which the
Company no longer has marketing rights. In addition, revenue for the first quarter of 2011
reflects lower revenue from the Companys relationship with AstraZeneca LP (AZLP).
|
|
|
* |
|
Cozaar and Hyzaar are registered trademarks of
E.I. duPont de Nemours & Company, Wilmington, Delaware. |
- 32 -
Sales of the Companys products were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
Cardiovascular |
|
|
|
|
|
|
|
|
Zetia |
|
$ |
582 |
|
|
$ |
534 |
|
Vytorin |
|
|
480 |
|
|
|
477 |
|
Integrilin |
|
|
64 |
|
|
|
70 |
|
Diabetes and Obesity |
|
|
|
|
|
|
|
|
Januvia |
|
|
739 |
|
|
|
511 |
|
Janumet |
|
|
305 |
|
|
|
201 |
|
Diversified Brands |
|
|
|
|
|
|
|
|
Cozaar/Hyzaar |
|
|
426 |
|
|
|
782 |
|
Zocor |
|
|
127 |
|
|
|
116 |
|
Claritin Rx |
|
|
120 |
|
|
|
98 |
|
Propecia |
|
|
106 |
|
|
|
100 |
|
Proscar |
|
|
60 |
|
|
|
58 |
|
Remeron |
|
|
60 |
|
|
|
51 |
|
Vasotec/Vaseretic |
|
|
57 |
|
|
|
59 |
|
Infectious Disease |
|
|
|
|
|
|
|
|
Isentress |
|
|
292 |
|
|
|
232 |
|
PegIntron |
|
|
166 |
|
|
|
186 |
|
Cancidas |
|
|
158 |
|
|
|
153 |
|
Primaxin |
|
|
136 |
|
|
|
159 |
|
Avelox |
|
|
106 |
|
|
|
106 |
|
Invanz |
|
|
87 |
|
|
|
75 |
|
Noxafil |
|
|
55 |
|
|
|
49 |
|
Rebetol |
|
|
53 |
|
|
|
56 |
|
Crixivan/Stocrin |
|
|
45 |
|
|
|
52 |
|
Neurosciences and Ophthalmology |
|
|
|
|
|
|
|
|
Maxalt |
|
|
173 |
|
|
|
135 |
|
Cosopt/Trusopt |
|
|
114 |
|
|
|
115 |
|
Oncology |
|
|
|
|
|
|
|
|
Temodar |
|
|
248 |
|
|
|
274 |
|
Emend |
|
|
87 |
|
|
|
84 |
|
Intron A |
|
|
49 |
|
|
|
54 |
|
Respiratory and Immunology |
|
|
|
|
|
|
|
|
Singulair |
|
|
1,328 |
|
|
|
1,165 |
|
Remicade |
|
|
753 |
|
|
|
674 |
|
Nasonex |
|
|
373 |
|
|
|
320 |
|
Clarinex |
|
|
155 |
|
|
|
164 |
|
Arcoxia |
|
|
114 |
|
|
|
95 |
|
Asmanex |
|
|
60 |
|
|
|
51 |
|
Simponi |
|
|
54 |
|
|
|
10 |
|
Proventil |
|
|
42 |
|
|
|
57 |
|
Dulera |
|
|
13 |
|
|
|
|
|
Vaccines (1) |
|
|
|
|
|
|
|
|
ProQuad/M-M-R II/Varivax |
|
|
244 |
|
|
|
319 |
|
Gardasil |
|
|
214 |
|
|
|
233 |
|
RotaTeq |
|
|
125 |
|
|
|
93 |
|
Pneumovax |
|
|
79 |
|
|
|
51 |
|
Zostavax |
|
|
24 |
|
|
|
95 |
|
Womens Health and Endocrine |
|
|
|
|
|
|
|
|
Fosamax |
|
|
208 |
|
|
|
230 |
|
NuvaRing |
|
|
142 |
|
|
|
135 |
|
Follistim AQ |
|
|
133 |
|
|
|
134 |
|
Implanon |
|
|
60 |
|
|
|
51 |
|
Cerazette |
|
|
59 |
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
Other pharmaceutical (2) |
|
|
745 |
|
|
|
946 |
|
|
Total Pharmaceutical segment sales |
|
|
9,820 |
|
|
|
9,665 |
|
|
Other segment sales (3) |
|
|
1,609 |
|
|
|
1,570 |
|
|
Total segment sales |
|
|
11,429 |
|
|
|
11,235 |
|
|
Other (4) |
|
|
151 |
|
|
|
187 |
|
|
|
|
$ |
11,580 |
|
|
$ |
11,422 |
|
|
|
|
|
(1) |
|
These amounts do not reflect sales of vaccines sold in most major European
markets through the Companys joint venture, Sanofi Pasteur MSD, the results of which are
reflected in Equity income from affiliates. These amounts do, however, reflect supply sales
to Sanofi Pasteur MSD. |
|
(2) |
|
Other pharmaceutical primarily includes sales of other human pharmaceutical
products, including products within the franchises not listed separately. |
|
(3) |
|
Reflects other non-reportable segments, including Animal Health and Consumer Care,
and revenue from the Companys relationship with AZLP primarily relating to sales of Nexium,
as well as Prilosec. Revenue from AZLP was $322 million and $364 million for the first
quarter of 2011 and 2010, respectively. |
|
(4) |
|
Other revenues are primarily comprised of miscellaneous corporate revenues,
third-party manufacturing sales, sales related to divested products or businesses and other
supply sales not included in segment results. |
- 33 -
The provision for discounts includes indirect customer discounts that occur when a
contracted customer purchases directly through an intermediary wholesale purchaser, known as
chargebacks, as well as indirectly in the form of rebates owed based upon definitive contractual
agreements or legal requirements with private sector and public sector (Medicaid and Medicare Part
D) benefit providers, after the final dispensing of the product by a pharmacy to a benefit plan
participant. These discounts, in the aggregate, reduced revenues by $1.2 billion for both the
three months ended March 31, 2011 and the three months ended
March 31, 2010. Inventory levels at key U.S. wholesalers for
each of the Companys major pharmaceutical products are generally less than one month.
Pharmaceutical Segment Revenues
Cardiovascular
Sales of Zetia (also marketed as Ezetrol outside the United States), a cholesterol-absorption
inhibitor, were $582 million in the first quarter of 2011, an increase of 9% compared with the
first quarter of 2010, reflecting growth in international markets, favorable pricing and the
positive impact of foreign exchange. Sales of Vytorin (marketed outside the United States as
Inegy), a combination product containing the active ingredients of both Zetia and Zocor, were $480
million for the first quarter of 2011, representing a 1% increase compared with the same period in
2010, reflecting growth in international markets, partially offset by declines in the United
States.
In September 2010, the intravenous formulation of Brinavess (vernakalant) was granted
marketing approval in the European Union (EU), Iceland and Norway for the rapid conversion of recent onset atrial
fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of seven
days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less.
Brinavess acts preferentially in the atria and is the first product in a new class of pharmacologic
agents for cardioversion of atrial fibrillation to launch in the EU. In April
2009, Cardiome Pharma Corp. and Merck announced a collaboration and license agreement for the
development and commercialization of vernakalant. The agreement provides Merck exclusive rights
outside of the United States, Canada and Mexico to vernakalant intravenous formulation.
Diabetes and Obesity
Global sales of Januvia, Mercks dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment
of type 2 diabetes, were $739 million in the first quarter of 2011, an increase of 45% compared
with the first quarter of 2010, reflecting growth in the United States, as well in international
markets, particularly in Japan. DPP-4 inhibitors represent a class of prescription medications
that improve blood sugar control in patients with type 2 diabetes by enhancing a natural body
system called the incretin system, which helps to regulate glucose by affecting the beta cells and
alpha cells in the pancreas.
Worldwide sales of Janumet, Mercks oral antihyperglycemic agent that combines sitagliptin
(Januvia) with metformin in a single tablet to target all three key defects of type 2 diabetes,
were $305 million for the first quarter of 2011, an increase of 52% compared with the first quarter
of 2010, reflecting growth both in the United States and internationally.
MK-0431A XR, the Companys investigational extended-release formulation of Janumet, was
accepted for standard review by the U.S. Food and Drug Administration (FDA) in 2010. The Company is also moving forward as planned
with regulatory filings in countries outside the United States. The extended-release formulation
of Janumet is an investigational treatment for type 2 diabetes that combines sitagliptin with
metformin extended release, a commonly-prescribed medication for type 2 diabetes, into a single
tablet. This formulation is designed to provide a new treatment option for health care providers
and patients who need two or more oral agents to help control their blood sugar with the
convenience of once daily dosing.
Diversified Brands
Mercks diversified brands are human health pharmaceutical products that are approaching the
expiration of their marketing exclusivity or are no longer protected by patents in developed
markets, but continue to be a core part of the Companys offering in other markets around the
world.
Global sales of Cozaar and its companion agent Hyzaar (a combination of Cozaar and
hydrochlorothiazide) for the treatment of hypertension fell 46% in the first quarter of 2011
compared with the same period in 2010. The patents that provided U.S. market exclusivity for
Cozaar and Hyzaar expired in April 2010. In addition, Cozaar and Hyzaar lost patent protection in
a number of major European markets in March 2010. Accordingly, the Company is experiencing a
significant decline in Cozaar and Hyzaar worldwide sales and the Company expects such decline to
continue.
Other products contained in the Diversified Brands franchise include among others, Zocor, a
statin for modifying cholesterol; prescription Claritin for the treatment of seasonal outdoor
allergies and year-round indoor allergies; Propecia, a product for the treatment of male pattern
hair loss; Proscar, a urology product for the treatment of symptomatic benign prostate enlargement;
Remeron, an antidepressant; and Vasotec/Vaseretic for hypertension and/or heart failure. Remeron
lost market exclusivity in the United States in January 2010 and in certain markets in the EU in
September 2010.
- 34 -
Infectious Disease
Global sales of Isentress, an HIV integrase inhibitor for use in combination with other
antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and
treatment-experienced adults, were $292 million in the first quarter of 2011, an increase of 26%
compared with the first quarter of 2010, reflecting positive performance in the United States and
Europe. Isentress works by inhibiting the
insertion of HIV DNA into human DNA by the integrase enzyme. Inhibiting integrase from performing
this essential function helps to limit the ability of the virus to replicate and infect new cells.
Worldwide sales of PegIntron for treating chronic hepatitis C were $166 million for the first
quarter of 2011, a decline of 11% compared with the same period in 2010, which the Company believes was attributable in part to patient treatment being delayed by health care providers in anticipation of new therapeutic options becoming available.
Sales of Primaxin, an anti-bacterial product, were $136 million in the first quarter of 2011,
a decline of 14% compared with the first quarter of 2010, primarily reflecting unfavorable pricing
and lower volumes due to competitive pressures. Patents on Primaxin have expired worldwide and
multiple generics have been approved in Europe. Accordingly, the Company is experiencing a decline
in sales of this product and the Company expects the decline to continue.
Other products contained in the Infectious Disease franchise include among others, Cancidas,
an anti-fungal product; Avelox, a fluoroquinolone antibiotic for the treatment of certain
respiratory and skin infections; Invanz for the treatment of certain infections; Noxafil for the
prevention of invasive fungal infections; Rebetol for use in combination with PegIntron for
treating chronic hepatitis C; and Crixivan and Stocrin, antiretroviral therapies for the treatment
of HIV infection. The compound patent that provides U.S. market exclusivity for Crixivan expires in 2012.
Neurosciences and Ophthalmology
Global sales of Maxalt, Mercks tablet for the acute treatment of migraine, were $173 million
for the first quarter of 2011, an increase of 29% compared with the first quarter of 2010
reflecting a higher inventory level in the United States, partially offset by a decline in Japan.
The compound patent that provides market exclusivity for Maxalt in the United States expires in
June 2012 (although the six month Pediatric Market Exclusivity may extend this date to December
2012). In addition, the patent for Maxalt will expire in a number of major European markets in
2013. The Company anticipates that sales in the United States and in these European markets will
decline significantly after these patent expiries.
Worldwide sales of ophthalmic products Cosopt and Trusopt were $114 million in the first
quarter of 2011, a decline of 1% compared with the first quarter of
2010, reflecting unfavorable
pricing in Europe largely offset by higher sales in Japan. The patent that provided U.S. market
exclusivity for Cosopt and Trusopt expired in October 2008. Trusopt has also lost market
exclusivity in a number of major European markets. The patent for Cosopt will expire in a number
of major European markets in March 2013 and the Company expects sales in those markets to decline
significantly thereafter.
In April 2011, the New Drug Application (NDA) for Mercks investigational preservative-free
formulation of Cosopt ophthalmic solution, containing a combination topical carbonic anhydrase
inhibitor and beta-andrenergic receptor blocking agent, was accepted for standard review by the
FDA.
Bridion, for the reversal of certain muscle relaxants during surgery, is currently approved
and has launched in many countries outside of the United States. Bridion is in Phase III
development in the United States.
In August 2009, the FDA approved Saphris (asenapine) for the acute treatment of schizophrenia
in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder
with or without psychotic features in adults. In September 2010,
two supplemental NDAs
for Saphris were approved in the United States to expand the products
indications to the treatment of schizophrenia in adults, as monotherapy for the acute treatment of
manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy
with either lithium or valproate for the acute treatment of manic or mixed episodes associated with
bipolar I disorder in adults. In September 2010, asenapine, to be sold under the brand name
Sycrest, received marketing approval in the EU for the treatment of moderate to severe manic
episodes associated with bipolar I disorder in adults; the marketing approval did not include an
indication for schizophrenia. In October 2010, Merck and H. Lundbeck A/S (Lundbeck) announced a
worldwide commercialization agreement for Sycrest sublingual tablets (5 mg, 10 mg). Under the
terms of the agreement, Lundbeck paid a fee and will make product supply payments in exchange for
exclusive commercial rights to Sycrest in all markets outside the United States, China and Japan.
Merck will retain exclusive commercial rights to asenapine in the United States, China and Japan.
Concurrently, Merck is continuing to pursue regulatory approval for asenapine in other parts of the
world.
Merck continues to focus on building the brand awareness of Saphris in the United States.
Merck launched a black cherry flavor of the sublingual tablet to provide an additional taste
option. Merck continues to monitor and assess Saphris/Sycrest and the related intangible asset.
If increasing the brand awareness, the additional flavor option, or Lundbecks launch of the
product in the EU is not successful, the Company may take a non-cash impairment charge with respect
to Saphris/Sycrest, and such charge could be material.
- 35 -
The Neurosciences and Ophthalmology franchise also included the products Subutex/Suboxone for
the treatment of opiate addiction. In 2010, Merck sold the rights to Subutex/Suboxone back to
Reckitt Benckiser Group PLC (Reckitt) and the rights to the products in most major markets have
reverted to Reckitt. Sales of Subutex/Suboxone were $52 million in the first quarter of 2010.
Oncology
Sales of Temodar (marketed as Temodal outside the United States), a treatment for certain
types of brain tumors, were $248 million for the first quarter of 2011, a decline of 10% compared
with the first quarter of 2010 primarily reflecting generic competition in Europe. Temodar lost
patent exclusivity in the EU in 2009 and generic products are being marketed.
Global sales of Emend, a treatment for chemotherapy-induced nausea and vomiting, were $87
million in the first quarter of 2011, an increase of 4% compared with the first quarter of 2010.
Other products in the Oncology franchise include among others, Intron A for treating melanoma.
Marketing rights for Caelyx for the treatment of ovarian cancer, metastatic breast cancer and
Kaposis sarcoma transitioned to Johnson & Johnson as of December 31, 2010. Sales of Caelyx were
$74 million in the first quarter of 2010.
In March 2011, the FDA approved Sylatron (peginterferon alfa-2b), a once-weekly subcutaneous
injection indicated for the adjuvant treatment of melanoma with microscopic or gross nodal
involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
Respiratory and Immunology
Worldwide sales for Singulair, a once-a-day oral medicine indicated for the chronic treatment
of asthma and for the relief of symptoms of allergic rhinitis, were $1.3 billion for the first
quarter of 2011, an increase of 14% compared with the first quarter of 2010. Sales growth was
driven by strong performance in the United States reflecting
favorable pricing and volume growth, as well as growth in
Japan and Asia Pacific. Singulair continues to be the number one prescribed branded product in the
U.S. respiratory market. Full year U.S. sales of Singulair were $3.2 billion in 2010. The patent
that provides U.S. market exclusivity for Singulair expires in August 2012. The Company expects
that within the two years following patent expiration, it will lose substantially all U.S. sales of
Singulair, with most of those declines coming in the first full year following patent expiration.
In addition, the patent for Singulair will expire in a number of major European markets in August
2012 and the Company expects sales of Singulair in those markets will decline significantly
thereafter (although the six month Pediatric Market Exclusivity may extend this date in some
markets to February 2013).
Sales of Remicade, a treatment for inflammatory diseases, were $753 million for the first
quarter of 2011, an increase of 12% compared with the first quarter
of 2010, reflecting positive
performance in Canada and Latin America, primarily Brazil, and certain European markets. Remicade
is marketed by the Company outside of the United States (except in Japan and certain other Asian
markets). Products that compete with Remicade have been launched over the past several years.
Simponi, a once-monthly subcutaneous treatment for certain inflammatory diseases, was approved by
the EC in October 2009. Launches in other international markets are planned. In January 2011,
Simponi was approved in the EU for use in combination with methotrexate in adults with severe,
active and progressive rheumatoid arthritis not previously treated with methotrexate and for the
reduction in the rate of progression of joint damage as measured by X-ray in rheumatoid arthritis
patients. Sales of Simponi were $54 million in the first quarter of 2011 compared with $10 million
in the first quarter of 2010. As a result of the agreement reached in April 2011 to amend the
distribution rights to Remicade and Simponi (see Note 9 to the interim consolidated financial
statements), effective July 1, 2011, Merck will relinquish marketing rights for these products in
certain territories including Canada, Central and South America, the Middle East, Africa and Asia
Pacific.
Global sales of Nasonex, an inhaled nasal corticosteroid for the treatment of nasal allergy
symptoms, were $373 million for the first quarter of 2011, an increase of 17% compared with the
first quarter of 2010, driven largely by positive performance in Japan.
Global sales of Clarinex (marketed as Aerius in many countries outside the United States), a
non-sedating antihistamine, were $155 million for the first quarter of 2011, a decline of 5%
compared with the first quarter of 2010.
Other products included in the Respiratory and Immunology franchise include among others,
Arcoxia for the treatment of arthritis and pain; Asmanex, an inhaled corticosteroid for asthma;
Proventil inhalation aerosol for the relief of bronchospasm; and Dulera Inhalation Aerosol for the treatment of asthma.
- 36 -
Vaccines
The following discussion of vaccines does not include sales of vaccines sold in most major
European markets through Sanofi Pasteur MSD (SPMSD), the Companys joint venture with Sanofi
Pasteur, the results of which are reflected in Equity income from affiliates (see Selected Joint
Venture and Affiliate Information below). Supply sales to SPMSD, however, are included.
As
previously disclosed, U.S. vaccine sales for certain products in the first quarter of 2010 benefited from inventory build-up during the
quarter, which affects comparisons with the first quarter of 2011.
Worldwide sales of Gardasil recorded by Merck declined 8% in the first quarter of 2011 to $214
million driven primarily by lower government orders in Canada. Gardasil, the worlds
top-selling human papillomavirus (HPV) vaccine, is indicated for girls and women 9 through 26
years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and
18, precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18, and genital warts
caused by HPV types 6 and 11. Gardasil is also approved in the United States for use in boys and
men ages 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and
11. In December 2010, the FDA approved a new indication for Gardasil for the prevention of anal
cancer caused by HPV types 16 and 18 and for the prevention of anal intraepithelial neoplasia
grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18,
in males and females 9 through 26 years of age.
In April 2011, the FDA completed its review of Mercks supplemental Biologics License
Application for an indication to use Gardasil in women ages 27-45. An indication for adult
women was not granted; instead, the Limitations of Use and Effectiveness for Gardasil was updated
to state that Gardasil has not been demonstrated to prevent HPV-related cervical intraepithelial
neoplasia 2/3 or worse in women older than 26 years of age. End of study data from the clinical
study evaluating the use of the vaccine in this age group was also added to the prescribing
information.
Global sales of RotaTeq, a vaccine to help protect against rotavirus gastroenteritis in
infants and children, recorded by Merck were $125 million in the first quarter of 2011, an increase
of 35% compared with the first quarter of 2010, reflecting favorable public sector inventory
fluctuations.
In recent years, the Company has experienced difficulties in producing its varicella zoster
virus (VZV)-containing vaccines. These difficulties have resulted in supply constraints for
ProQuad, Varivax and Zostavax. The Company is manufacturing bulk varicella and is producing doses
of Varivax and Zostavax.
A limited quantity of ProQuad, a pediatric combination vaccine to help protect against
measles, mumps, rubella and varicella, one of the VZV-containing vaccines, became available in the
United States for ordering in the second quarter of 2010. This supply has been exhausted and the
Company does not anticipate availability of ProQuad for the remainder of 2011. Sales of ProQuad as
recorded by Merck were $37 million in the first quarter of 2011.
Mercks sales of Varivax, a vaccine to help prevent chickenpox (varicella), were $144 million
for the first quarter of 2011 compared with $237 million for the first quarter of 2010. Sales in
the first quarter of 2010 include $48 million of revenue as a result of government purchases for
the U.S. Centers for Disease Control and Preventions Strategic National Stockpile. Mercks sales
of M-M-R II, a vaccine to help protect against measles, mumps and rubella, were $63 million for the
first quarter of 2011 compared with $83 million for the first quarter of 2010. Sales of Varivax
and M-M-R II in the first quarter of 2010 benefited from the unavailability of ProQuad as noted
above.
Mercks sales of Zostavax, a vaccine to help prevent shingles (herpes zoster), were $24
million for the first quarter of 2011 as compared with $95 million in the first quarter of 2010.
Sales in both periods were affected by continuing supply issues. Merck will continue to accept
orders for Zostavax, but the vaccine remains on backorder. The Company anticipates sales will be
affected by continued intermittent supply issues for the remainder of 2011. Due to these supply
constraints, no international launches or immunization programs are currently planned for 2011.
In March 2011, the FDA approved an expanded age indication for Zostavax for the prevention of
shingles to include adults ages 50 to 59. Zostavax is now indicated for the prevention of herpes zoster in individuals 50 years of age and older.
The Company anticipates the availability of the adult formulation of Recombivax HB, a vaccine against hepatitis B, in the
second half of 2011.
Womens Health and Endocrine
Worldwide sales for Fosamax and Fosamax Plus D (marketed as Fosavance throughout the EU and as
Fosamac in Japan) for the treatment and, in the case of Fosamax, prevention of osteoporosis were
$208 million for the first quarter of 2011, representing a decline of 10% over the comparable
period of 2010. These medicines have lost market exclusivity in the United States and have also
lost market exclusivity in most major European markets. Accordingly, the Company is experiencing
significant sales declines within the Fosamax product franchise and the Company expects the
declines to continue.
- 37 -
Worldwide sales of NuvaRing, a contraceptive product, were $142 million for the first quarter
of 2011, an increase of 5% compared with the first quarter of 2010. Global sales of Follistim AQ
(marketed in most countries outside the United States as Puregon), a fertility treatment, were $133
million for the first quarter of 2011, comparable with sales in the first quarter of 2010. Puregon
lost market exclusivity in the EU in August 2009.
Other products contained in the Womens Health and Endocrine franchise include among others,
Implanon, a single-rod subdermal contraceptive implant; and Cerazette, a progestin only oral
contraceptive.
The Company is currently experiencing difficulty manufacturing certain womens health
products. The Company is working to resolve these issues.
Other
Animal Health
Animal Health includes pharmaceutical and vaccine products for the prevention, treatment and
control of disease in all major farm and companion animal species. Animal Health sales are
affected by intense competition and the frequent introduction of generic products. Global sales of
Animal Health products totaled $758 million for the first quarter of 2011, an increase of 7%
compared with the first quarter of 2010, reflecting positive performance across the product
portfolio. During the first quarter of 2011, the Company and sanofi-aventis mutually terminated
their agreement to form an animal health joint venture. (See Selected Joint Venture and Affiliate
Information below.)
Consumer Care
Consumer Care products include over-the-counter, foot care and sun care products such as Dr.
Scholls foot care products; Claritin non-drowsy antihistamines; MiraLAX, a treatment for
occasional constipation; and Coppertone sun care products. Global sales of Consumer Care products
were $517 million for the first quarter of 2011, an increase of 6% compared with the first quarter
of 2010, reflecting strong performance of a number of key brands including Claritin and Coppertone.
Consumer Care product sales are affected by competition, frequent competitive product introductions
and consumer spending patterns.
Alliances
AstraZeneca has an option to buy Old Mercks interest in Nexium and Prilosec, exercisable in
2012, and the Company believes that it is likely that AstraZeneca will exercise that option (see
Selected Joint Venture and Affiliate Information below). If AstraZeneca does exercise the option, the Company will no longer recognize equity income from AZLP and supply sales to AZLP
will decline substantially.
Costs, Expenses and Other
In February 2010, the Company commenced actions under a global restructuring program (the
Merger Restructuring Program) in conjunction with the integration of the legacy Merck and legacy
Schering-Plough businesses. This Merger Restructuring Program is intended to optimize the cost
structure of the combined company. Additional actions under the program continued during 2010.
As part of the restructuring actions taken thus far under the Merger Restructuring Program, the
Company expects to reduce its total workforce measured at the time of the Merger by approximately
17% across the Company worldwide. In addition, the Company has eliminated over 2,500 positions
which were vacant at the time of the Merger. These workforce reductions will primarily come from
the elimination of duplicative positions in sales, administrative and headquarters organizations,
as well as from the sale or closure of certain manufacturing and research and development sites and
the consolidation of office facilities. During this period, the Company will continue to hire new
employees in strategic growth areas of the business as necessary. The Company will continue to pursue productivity efficiencies and
evaluate its manufacturing supply chain capabilities on an ongoing basis which may result in future
restructuring actions.
In connection with the Merger Restructuring Program, separation costs under the Companys
existing severance programs worldwide were recorded in the fourth quarter of 2009 to the extent
such costs were probable and reasonably estimable. The Company commenced accruing costs related to
enhanced termination benefits offered to employees under the Merger Restructuring Program in the
first quarter of 2010 when the necessary criteria were met. The Company recorded total pretax
restructuring costs of $112 million and $283 million in the first quarter of 2011 and 2010,
respectively, related to this program. The restructuring actions taken thus far under the Merger
Restructuring Program are expected to be substantially completed by the end of 2012, with the
exception of certain manufacturing facilities actions, with the total cumulative pretax costs
estimated to be approximately $3.8 billion to $4.6 billion. The Company estimates that
approximately two-thirds of the cumulative pretax costs relate to cash outlays, primarily related
to employee separation expense. Approximately one-third of the cumulative pretax costs are
non-cash, relating primarily to the accelerated depreciation of facilities to be closed or
divested. The Company expects the restructuring actions taken thus far under the Merger
Restructuring Program to result in annual savings in 2012 of approximately $2.7 billion to $3.1
billion. These cost savings, which are expected to come from all areas of the Companys
pharmaceutical business, are in addition to the previously announced ongoing cost reduction
initiatives at both legacy companies. Additional savings will come from non-restructuring-related
activities.
- 38 -
In October 2008, Old Merck announced a global restructuring program (the 2008 Restructuring
Program) to reduce its cost structure, increase efficiency, and enhance competitiveness. As part
of the 2008 Restructuring Program, the Company expects to eliminate approximately 7,200 positions
6,800 active employees and 400 vacancies across the Company worldwide by the end of 2011.
Pretax restructuring costs of $4 million and $65 million were recorded in the first quarter of 2011
and 2010, respectively, related to the 2008 Restructuring Program. The 2008 Restructuring Program
is expected to be completed by the end of 2011 with the total cumulative pretax costs estimated to
be $1.6 billion to $2.0 billion. The Company estimates that two-thirds of the cumulative pretax
costs relate to cash outlays, primarily from employee separation expense. Approximately one-third
of the cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of
facilities to be closed or divested. Merck expects the 2008 Restructuring Program to yield
cumulative pretax savings of $3.8 billion to $4.2 billion from 2008 to 2013.
The Company anticipates that total costs associated with restructuring activities in 2011 for
the Merger Restructuring Program and the 2008 Restructuring Program will be in the range of $700
million to $900 million.
The costs associated with all of these restructuring activities are primarily comprised of
accelerated depreciation and separation costs recorded in Materials and production, Marketing and
administrative, Research and development and Restructuring costs (see Note 2 to the interim
consolidated financial statements).
Materials and production costs were $4.1 billion for the first quarter of 2011, a decline of
22% compared with the first quarter of 2010. Costs in the first
quarter of 2011 and the first quarter of 2010
include $1.2 billion of expenses for the amortization of intangible assets recognized in the Merger.
Additionally, expenses for the first quarter of 2010 included $1.2 billion of amortization of
purchase accounting adjustments to Schering-Ploughs inventories also recognized as a result of the
Merger. Also included in materials and production costs were costs associated with restructuring
activities which amounted to $72 million and $57 million in the first quarter of 2011 and 2010,
respectively, including accelerated depreciation and asset write-offs related to the planned sale
or closure of manufacturing facilities. Separation costs associated with manufacturing-related
headcount reductions have been incurred and are reflected in Restructuring costs as discussed
below. (See Note 2 to the interim consolidated financial statements.)
Gross margin was 64.9% in the first quarter of 2011 compared with 54.3% in the first quarter
of 2010. The amortization of intangible assets and purchase accounting adjustments to inventories
recorded as a result of the Merger, as well as the restructuring
charges noted above and certain merger-related costs had an
unfavorable effect on gross margin of 11.9 and 21.1 percentage points, respectively. Excluding
these impacts, the gross margin improvement reflects changes in product mix and lower costs due to
manufacturing efficiencies.
Marketing and administrative expenses were $3.2 billion in the first quarter of 2011, a
decline of 2% compared with the first quarter of 2010. The
decline in marketing and administrative expenses was largely driven by initiatives to reduce the
cost base.
Expenses for the first quarter of 2011
included $23 million of restructuring costs, primarily related to accelerated depreciation for
facilities to be closed or divested. Separation costs associated with sales force reductions have
been incurred and are reflected in Restructuring costs as discussed below.
Marketing and administrative expenses included $58 million and $80 million of merger-related costs in
the first quarter of 2011 and 2010, respectively, consisting largely
of integration costs. Additionally, marketing and administrative
expenses in the first quarter of 2011 include $42 million of
expenses representing one-fourth of the estimated annual health care reform fee which the Company
will be required to pay beginning in 2011 as part of U.S. health care reform legislation.
Research and development expenses were $2.2 billion for the first quarter of 2011, an increase
of 5% compared with the first quarter of 2010. During the first
quarter of 2011, the Company
recorded $302 million of in-process research and development
(IPR&D) impairment charges primarily for programs that
had previously been deprioritized and were deemed to have no alternative use during the quarter. During the first
quarter of 2010, the Company recorded $27 million of IPR&D impairment charges attributable to
compounds identified during the Companys pipeline prioritization review that were abandoned and
determined to have either no alternative use or were returned to the respective licensor. The
Company may recognize additional non-cash impairment charges in the future for the cancellation of
other legacy Schering-Plough pipeline programs that were measured at fair value and capitalized in
connection with the Merger and such charges could be material. Also, expenses in the first quarter
of 2011 and 2010 reflect $45 million and $6 million, respectively, of accelerated depreciation and
asset abandonment costs associated with restructuring activities. These increases in research and
development expenses were partially offset by cost savings resulting from restructuring activities,
as well as by the timing of the clinical grant spending.
Restructuring costs, primarily representing separation and other related costs associated with
restructuring activities, were a credit of $14 million in the first quarter of 2011 which reflects
a reduction of separation reserves of approximately $50 million resulting from the Companys
decision in the first quarter to retain approximately 380 employees at its Oss, Netherlands
research facility that had previously been expected to be separated. Restructuring costs were $288
million in the first quarter of 2010, of which $252 million related to the Merger Restructuring
Program and $36 million related to the 2008 Restructuring Program. Separation costs were incurred
associated with actual headcount reductions, as well as estimated expenses under existing severance
programs for headcount reductions that were probable and could be reasonably estimated. Merck
eliminated approximately 870 positions in the
- 39 -
first quarter of 2011 of which 750 related to the
Merger Restructuring Program and 120 related to the 2008
Restructuring Program. For the first quarter of 2010,
Merck eliminated 5,730 positions of which 5,150 related to the Merger Restructuring Program, 535
related to the 2008 Restructuring Program and the remainder to the legacy Schering-Plough
Productivity Transformation Program. These position eliminations are comprised of actual headcount
reductions, and the elimination of contractors and vacant positions. Also included in
restructuring costs are curtailment, settlement and termination charges on pension and other
postretirement benefit plans and shutdown costs. For segment reporting, restructuring costs are
unallocated expenses. Additional costs associated with the Companys restructuring activities are
included in Materials and production, Marketing and administrative and Research and development.
(See Note 2 to the interim consolidated financial statements.)
Equity income from affiliates, which reflects the performance of the Companys joint ventures
and other equity method affiliates, primarily AZLP, was $138 million in both the first quarter of
2011 and the first quarter of 2010. (See Selected Joint Venture and Affiliate Information
below.)
Other (income) expense, net was $622 million of expense in the first quarter of 2011 compared
with $167 million of expense in the first quarter of 2010. During the first quarter of 2011, the
Company recorded a $500 million charge related to the resolution of the arbitration proceeding
involving the Companys rights to market Remicade and Simponi (see Note 9 to the interim
consolidated financial statements). Also during the first quarter of 2011, the Company recorded a
$134 gain on the sale of certain manufacturing facilities and related assets. Included in other
(income) expense, net in the first quarter of 2010 was $102 million of income on the settlement of
certain disputed royalties. Also, during the first quarter of 2010, the Company recognized
exchange losses of $80 million related to a Venezuelan currency devaluation. Effective January 11,
2010, the Venezuelan government devalued its currency from at BsF 2.15 per U.S. dollar to a
two-tiered official exchange rate at (1) the essentials rate at BsF 2.60 per U.S. dollar and (2)
the non-essentials rate at BsF 4.30 per U.S. dollar. In
January 2010, Merck was required to remeasure its local
currency operations in Venezuela to U.S. dollars as the Venezuelan economy was determined to be
hyperinflationary. Throughout 2010, the Company settled its transactions at the essentials rate
and therefore remeasured monetary assets and liabilities using the
essentials rate. In December 2010, the Venezuelan government
announced it would eliminate the essentials rate and effective
January 1, 2011, all transactions would be settled at the official
rate of at BsF 4.30 per U.S. dollar. As a result of this
announcement, the Company remeasured its December 31, 2010 monetary
assets and liabilities at the new official rate.
Segment Profits
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Pharmaceutical segment profits |
|
$ |
6,216 |
|
|
$ |
5,740 |
|
Other non-reportable segment profits |
|
|
716 |
|
|
|
720 |
|
Other |
|
|
(5,203 |
) |
|
|
(5,844 |
) |
|
Income before income taxes |
|
$ |
1,729 |
|
|
$ |
616 |
|
|
Segment profits are comprised of segment revenues less certain elements of materials and
production costs and operating expenses, including components of equity income or loss from
affiliates and depreciation and amortization expenses. For internal management reporting presented
to the chief operating decision maker, Merck does not allocate production costs, other than
standard costs, research and development expenses or general and administrative expenses, nor the
cost of financing these activities. Separate divisions maintain responsibility for monitoring and
managing these costs, including depreciation related to fixed assets utilized by these divisions
and, therefore, they are not included in segment profits. Also excluded from the determination of
segment profits are the arbitration settlement charge in 2011,
the amortization of purchase accounting adjustments, IPR&D impairment charges, restructuring costs,
taxes paid at the joint venture level and a portion of equity income. Additionally, segment
profits do not reflect other expenses from corporate and manufacturing cost centers and other
miscellaneous income or expense. These unallocated items are reflected in Other in the above
table. Also included in Other are miscellaneous corporate profits, operating profits related to
third-party manufacturing sales, divested products or businesses, as well as other supply sales and
adjustments to eliminate the effect of double counting certain items of income and expense.
Pharmaceutical segment profits rose 8% in the first quarter of 2011 driven largely by the
increase in sales and the gross margin improvement discussed above.
The effective tax rate of 38.1% for the first quarter of 2011 reflects the impacts of purchase
accounting adjustments, restructuring costs and a $500 million charge related to the resolution of
the arbitration proceeding with Johnson & Johnson, which
collectively had a 24% unfavorable impact as compared with the
statutory rate. The effective tax rate was also affected by the
beneficial impact of foreign earnings. The effective tax rate of 46.4% for the first
quarter of 2010 reflects the impact of a $147 million charge associated with a change in tax law
that requires taxation of the prescription drug subsidy of the Companys retiree health benefit
plans which was enacted in the first quarter of 2010 as part of U.S. health care reform
legislation, as well as the impacts of purchase accounting adjustments and restructuring charges.
- 40 -
Net income attributable to Merck & Co., Inc. was $1.0 billion for the first quarter of 2011
compared with $299 million for the first quarter of 2010. Earnings per common share assuming
dilution attributable to Merck & Co., Inc. common shareholders (EPS) for the first quarter of
2011 were $0.34 compared with $0.09 in the first quarter of 2010. The increases in net income and
EPS in the first quarter of 2011 were primarily due to lower amortization of inventory step-up and
lower restructuring costs, partially offset by the arbitration settlement charge and higher IPR&D
impairment charges.
Non-GAAP income and non-GAAP EPS are alternative views of the Companys performance used by
management that Merck is providing because management believes this information enhances investors
understanding of the Companys results. Non-GAAP income and non-GAAP EPS exclude certain items
because of the nature of these items and the impact that they have on the analysis of underlying
business performance and trends. The excluded items consist of certain purchase accounting items
related to the Merger, restructuring activities, merger-related costs, and certain other items.
These excluded items are significant components in
understanding and assessing financial performance. Therefore, the information on non-GAAP
income and non-GAAP EPS should be considered in addition to, but not in lieu of, net income and EPS
prepared in accordance with generally accepted accounting principles in the United States (GAAP).
Additionally, since non-GAAP income and non-GAAP EPS are not measures determined in accordance
with GAAP, they have no standardized meaning prescribed by GAAP and, therefore, may not be
comparable to the calculation of similar measures of other companies.
Non-GAAP income and non-GAAP EPS are important internal measures for the Company. Senior
management receives a monthly analysis of operating results that includes non-GAAP income and
non-GAAP EPS and the performance of the Company is measured on this basis along with other
performance metrics. Senior managements annual compensation is derived in part using non-GAAP
income and non-GAAP EPS.
A reconciliation between GAAP financial measures and non-GAAP financial measures is as
follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
($ in millions, except per share amounts) |
|
2011 |
|
|
2010 |
|
|
Pretax income as reported under GAAP |
|
$ |
1,729 |
|
|
$ |
616 |
|
Increase (decrease) for excluded items: |
|
|
|
|
|
|
|
|
Purchase accounting adjustments |
|
|
1,580 |
|
|
|
2,374 |
|
Costs related to restructuring programs |
|
|
126 |
|
|
|
351 |
|
Merger-related costs |
|
|
77 |
|
|
|
87 |
|
Other items: |
|
|
|
|
|
|
|
|
Arbitration settlement charge |
|
|
500 |
|
|
|
|
|
Gain on
sale of manufacturing facilities and related assets |
|
|
(134 |
) |
|
|
|
|
|
|
|
|
3,878 |
|
|
|
3,428 |
|
|
|
|
|
|
|
|
|
|
|
Taxes on income as reported under GAAP |
|
|
658 |
|
|
|
286 |
|
Estimated tax benefit on excluded items |
|
|
331 |
|
|
|
650 |
|
Tax charge related to U.S. health care reform legislation |
|
|
|
|
|
|
(147 |
) |
|
|
|
|
989 |
|
|
|
789 |
|
|
Non-GAAP net income |
|
|
2,889 |
|
|
|
2,639 |
|
|
Less: Net income attributable to noncontrolling interests |
|
|
28 |
|
|
|
31 |
|
|
Non-GAAP net income attributable to Merck & Co., Inc. |
|
$ |
2,861 |
|
|
$ |
2,608 |
|
|
|
|
|
|
|
|
|
|
|
|
EPS assuming dilution as reported under GAAP |
|
$ |
0.34 |
|
|
$ |
0.09 |
|
EPS difference (1) |
|
|
0.58 |
|
|
|
0.74 |
|
|
Non-GAAP EPS assuming dilution |
|
$ |
0.92 |
|
|
$ |
0.83 |
|
|
|
|
|
(1) |
|
Represents the difference between calculated GAAP EPS and calculated non-GAAP
EPS, which may be different than the amount calculated by dividing the impact of the excluded items
by the weighted average shares for the applicable period. |
- 41 -
Purchase Accounting Adjustments
Non-GAAP income and non-GAAP EPS exclude the ongoing impact of certain amounts recorded in
connection with the Merger. These amounts include the amortization of intangible assets and
inventory step-up, as well as IPR&D impairment charges (see
Research and Development above).
Restructuring Costs
Non-GAAP income and non-GAAP EPS exclude costs related to restructuring actions, including
restructuring activities related to the Merger (see Note 2 to the interim consolidated financial
statements). These amounts include employee separation costs and accelerated depreciation
associated with facilities to be closed or divested. Accelerated depreciation costs represent the
difference between the depreciation expense to be recognized over the revised useful life of the
site, based upon the anticipated date the site will be closed or divested, and depreciation expense
as determined utilizing the useful life prior to the restructuring actions. The Company has
undertaken restructurings of different types during the covered periods and therefore these charges
should not be considered non-recurring; however, management excludes these amounts from non-GAAP
income and non-GAAP EPS because it believes it is helpful for understanding the performance of the
continuing business.
Merger-Related Costs
Non-GAAP income and non-GAAP EPS exclude transaction costs associated directly with the
Merger, as well as integration costs. These costs are excluded because management believes that
these costs are unique to the Merger transaction and are not representative of ongoing normal
business activities. Integration costs associated with the Merger will occur over several years,
however, the impacts within each year will vary as the integration progresses. Prior to the mutual
termination of the agreement with sanofi-aventis, these costs included costs associated with the
anticipated formation of an animal health joint venture with sanofi-aventis.
Certain Other Items
Non-GAAP income and non-GAAP EPS exclude certain other items. These items represent
substantive, unusual items that are evaluated on an individual basis. Such evaluation considers
both the quantitative and the qualitative aspect of their unusual nature and generally represent
items that, either as a result of their nature or magnitude, management would not anticipate that
they would occur as part of the Companys normal business on a regular basis. Certain other items
include the charge related to the arbitration settlement (see Note 9
to the interim consolidated financial
statements), and the gain associated with the sales of certain manufacturing facilities and related
assets.
Research and Development Update
In April 2011, the Antiviral Drugs Advisory Committee of the FDA voted unanimously that the
available data support approval of Mercks investigational medicine Victrelis (boceprevir) for the
treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination
with current standard therapy. Victrelis is one of a new class of medicines known as HCV protease
inhibitors being evaluated by the FDA for the treatment of chronic HCV genotype 1 infection in
adult patients with compensated liver disease who are previously untreated or who have failed
previous therapy. The committees recommendation will be considered by the FDA in its review of
the NDA for Victrelis. The FDA is not bound by the committees guidance, but
takes its advice into consideration when reviewing investigational medicines. The company
anticipates FDA action on Victrelis by mid-May. The FDA granted priority review status for
Victrelis, a designation for investigational medicines that address unmet medical needs.
Additionally, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application
for Victrelis for accelerated assessment.
Also in April 2011, Merck and Sanofi Pasteur announced the initiation of a Phase III clinical
program to evaluate the safety and immunogenicity of an investigational pediatric hexavalent
combination vaccine (V419). This combination vaccine is designed to help protect against six potentially
serious diseases: diphtheria, tetanus, whooping cough (Bordetella pertussis), polio (poliovirus
types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b, and hepatitis B. The
vaccine is being developed as part of a partnership between Merck and Sanofi Pasteur that focuses
on the development of pediatric combination vaccines. The Phase III clinical program will begin in
the United States with a randomized, open-label, active-comparator controlled clinical trial that
will involve approximately 1,440 infants at multiple centers. The primary study objectives are to
assess the safety and immunogenicity of the investigational hexavalent combination vaccine when
given at 2, 4, and 6 months of age concomitantly with Prevnar 13* Pneumococcal 13-valent Conjugate
Vaccine and RotaTeq. The clinical program is expected to begin in Europe this year. The Phase III
program was initiated following results from a Phase IIb clinical trial of 459 children that
assessed the safety and immunogenicity of the investigational combination vaccine.
|
|
|
* |
|
Prevnar 13 is a registered trademark of Wyeth LLC. |
- 42 -
Additionally, in April 2011, Merck announced that following a pre-specified interim
analysis from the Phase II/III clinical trial evaluating V710, an investigational vaccine for the
prevention of Staphylococcus aureus (S. aureus) infection, the independent Data Monitoring
Committee (DMC) recommended suspension of enrollment. Although the trial did not meet the
pre-specified futility criteria, the DMC nonetheless recommended suspension of enrollment pending
further analyses of the benefit/risk profile of the vaccine candidate.
In March 2011, NOMAC/E2, an investigational monophasic combined oral contraceptive tablet
indicated for the use by women to prevent pregnancy, was accepted for standard review by the FDA.
NOMAC-E2 is a birth control pill that contains two steroid hormones nomegestrol acetate, a highly
selective, progesterone-derived progestin and 17-beta estradiol (E2), an estrogen that is similar
to the one naturally present in a womans body. Also in March 2011, the Committee for Medicinal
Products for Human Use of the EMA adopted a positive opinion for NOMAC/E2. The next step for
marketing authorization in the EU is review by the European Commission.
Additionally, in March 2011, the NDA for MK-2452 (tafluprost), Mercks investigational
preservative-free prostaglandin analogue ophthalmic solution, was accepted for standard review by
the FDA. Merck submitted an NDA to support the proposed use of tafluprost for the reduction of
elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
MK-2452 is currently approved in several European countries, including the United Kingdom, Spain
and Italy, and is sold under the tradename Saflutan. Additional launches in other countries are
expected, pending regulatory approvals. On April 15, 2009, Merck and Santen Pharmaceutical Co.,
Ltd. (Santen) entered into a worldwide licensing agreement for tafluprost. Merck has exclusive
commercial rights to tafluprost in Western Europe (excluding Germany), North America, South
America, Africa, the Middle East, India and Australia. Santen retains commercial rights to
tafluprost in most countries in Eastern Europe, northern Europe and in countries in the Asia
Pacific region, including Japan. Santen will have the option to co-promote tafluprost in the
United States, if approved.
MK-0822, odanacatib, is an oral, once-weekly investigational treatment for osteoporosis in
post-menopausal women. Clinical and preclinical studies continue to provide data on the potential
of odanacatib to increase bone density, cortical thickness and bone strength when treating
osteoporosis. The ongoing, event-driven
Phase III Study of Odanacatib in Postmenopausal Women With Osteoporosis to Assess Fracture Risk completed enrollment in November 2009. Based on the accumulation of clinical events to date, Merck now anticipates filing an NDA with the FDA for MK-0822 in 2013.
Merck plans to return to Portola
Pharmaceuticals, Inc. all rights for betrixaban, an
investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke
in patients with atrial fibrillation. This decision was made following a review of Mercks
investigational portfolio.
In April 2011, Merck and Sun
Pharmaceutical Industries Ltd., a leading
Indian multinational pharmaceutical company, announced the creation of a joint venture to develop,
manufacture and commercialize new combinations and formulations of innovative, branded generics in
the emerging markets. The companies will focus on innovative branded generics that bring
together combinations of medicines using platform delivery technologies designed to enhance
convenience for patients in emerging markets.
- 43 -
The chart below reflects the Companys current research pipeline as of April 22, 2011.
Candidates shown in Phase III include specific products. Candidates shown in Phase II include the
most advanced compound with a specific mechanism or, if listed compounds have the same mechanism,
they are each currently intended for commercialization in a given therapeutic area. Small
molecules and biologics are given MK-number or SCH-number designations and vaccine candidates are
given V-number designations. Candidates in Phase I, additional indications in the same therapeutic
area and additional claims, line extensions or formulations for in-line products are not shown.
|
|
|
|
|
Phase II |
|
Phase III |
|
Combination Products in Development |
Allergy
SCH 900237, Immunotherapy(1)
Cancer
MK-0646 (dalotuzumab)
SCH 727965 (dinaciclib)
Clostridium difficile Infection
MK-3415A
Contraception, Medicated IUS
SCH 900342
COPD
SCH 527123 (navarixin)
Diabetes Mellitus
MK-3102
Hepatitis C
MK-7009 (vaniprevir)
Insomnia
MK-3697
MK-6096
Osteoporosis
MK-5442
Overactive Bladder
MK-4618
Pneumoconjugate Vaccine
V114
Progeria
SCH 066336 (lonafarnib)
Psoriasis
SCH 900222
Staph Infection
V710
|
|
Allergy
SCH 697243, Grass pollen(1)
SCH 039641, Ragweed(1)
Asthma
SCH 418131 (Zenhale) (EU)
Atherosclerosis
MK-0524A (extended-release niacin/
laropiprant) (U.S.)
MK-0524B (extended-release niacin/
laropiprant/simvastatin)
MK-0859 (anacetrapib)
Cervical Cancer
V503 (HPV vaccine (9 valent))
Diabetes
MK-0431C (sitagliptin/pioglitazone)
Fertility
SCH 900962 (corifollitropin alfa
injection) (U.S.)
Insomnia
MK-4305 (suvorexant)
Migraine
MK-0974 (telcagepant)
Neuromuscular Blockade Reversal
SCH 900616 (Bridion) (U.S.)
Osteoporosis
MK-0822 (odanacatib)
Parkinsons Disease
SCH 420814 (preladenant)
Pediatric Hexavalent Combination Vaccine
V419
Sarcoma
MK-8669 (ridaforolimus)
Thrombosis
SCH 530348 (vorapaxar)
Herpes Zoster
V212 (inactivated VZV vaccine)
|
|
Atherosclerosis
MK-0653C (ezetimibe/atorvastatin)
Contraception
SCH 900121 (NOMAC/E2) (EU) (U.S.)
Diabetes
MK-0431D (sitagliptin/simvastatin) (U.S.)
MK-0431A XR (sitagliptin/
extended-release metformin) (U.S.)
Glaucoma
MK-2452 (tafluprost) (U.S.)
Hepatitis C
SCH 503034 (Victrelis)
Staph Infection
MK-3009 (daptomycin for injection)(2)
Footnotes:
(1) North American rights only.
(2) Japanese rights only. |
- 44 -
Selected Joint Venture and Affiliate Information
AstraZeneca LP
In 1998, Old Merck and Astra completed the restructuring of the ownership and operations of
their existing joint venture whereby Old Merck acquired Astras interest in KBI Inc. (KBI) and
contributed KBIs operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P.
(the Partnership), in exchange for a 1% limited partner interest. Astra contributed the net
assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership in exchange for a 99%
general partner interest. The Partnership, renamed AstraZeneca LP (AZLP) upon Astras 1999 merger
with Zeneca Group Plc (the AstraZeneca merger), became the exclusive distributor of the products
for which KBI retained rights.
In connection with the 1998 restructuring, Astra purchased an option (the Asset Option) for
a payment of $443 million, which was recorded as deferred income, to buy Old Mercks interest in
the KBI products, excluding the gastrointestinal medicines Nexium and Prilosec (the Non-PPI
Products). In April 2010, AstraZeneca exercised the Asset Option. Merck received $647 million
from AstraZeneca, representing the net present value as of March 31, 2008 of projected future
pretax revenue to be received by Old Merck from the Non-PPI Products, which was recorded as a
reduction to the Companys investment in AZLP. The Company recognized the $443 million of
deferred income in the second quarter of 2010 as a component of Other (income) expense, net. In
addition, in 1998, Old Merck granted Astra an option (the Shares Option) to buy Old Mercks
common stock interest in KBI and, therefore, Old Mercks interest in Nexium and Prilosec,
exercisable in 2012. The exercise price for the Shares Option will be based on the net present
value of estimated future net sales of Nexium and Prilosec as determined at the time of exercise,
subject to certain true-up mechanisms. The Company believes that it is likely that AstraZeneca
will exercise the Shares Option. If AstraZeneca does exercise the Shares Option, the Company will no longer recognize equity
income from AZLP and supply sales to AZLP will decline substantially.
Sanofi Pasteur MSD
In 1994, Old Merck and Pasteur Mérieux Connaught (now Sanofi Pasteur S.A.) established an
equally-owned joint venture to market vaccines in Europe and to collaborate in the development of
combination vaccines for distribution in Europe. Total vaccine sales reported by SPMSD were $187
million and $251 million in the first quarter of 2011 and 2010, respectively. The decline reflects
lower sales of Gardasil. SPMSD sales of Gardasil were $58 million and $82 million for the first
quarter of 2011 and 2010, respectively.
Other
In March 2011, Merck and sanofi-aventis mutually terminated their agreement to form a new
animal health joint venture by combining Intervet/Schering-Plough, Mercks animal health unit, with
Merial, the animal health business of sanofi-aventis. As a result of the termination, both Merial
and Intervet/Schering-Plough continue to operate independently. The termination of the agreement
was without penalty to either party.
The Company records the results from its interest in AZLP and SPMSD in Equity income from
affiliates.
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Cash and investments |
|
$ |
15,113 |
|
|
$ |
14,376 |
|
Working capital |
|
|
15,362 |
|
|
|
13,423 |
|
Total debt to total liabilities and equity |
|
|
16.9 |
% |
|
|
16.9 |
% |
|
During the first quarter of 2011, cash provided by operating activities was $1.7 billion
compared with $1.4 billion in the first quarter of 2010. On an ongoing basis, cash provided by
operations will continue to be the Companys primary source of funds to finance operating needs and
capital expenditures. The global economic downturn and the sovereign debt issues, among other
factors, have caused foreign receivables to deteriorate in certain European countries. While the
Company continues to receive payment on these receivables, these
conditions may continue to result in an
increase in the average length of time it takes to collect accounts receivable outstanding which
can impact cash provided by operating activities.
Cash provided by investing activities was $105 million in the first quarter of 2011 compared
with a use of cash in investing activities of $3.1 billion in the first quarter of 2010 primarily
reflecting lower purchases of securities and other investments and higher proceeds from the sales
of securities and other investments. In addition, the Company received proceeds from the
disposition of businesses in the first quarter of 2011. Cash used in financing activities in the
first quarter of 2011 was $1.2 billion compared with cash provided by financing activities of $942
million in the first quarter of 2010 primarily driven by a decrease in short-term borrowings,
partially offset by lower payments on debt.
- 45 -
At March 31, 2011, the total of worldwide cash and investments was $15.1 billion, including
$13.0 billion of cash, cash equivalents and short-term investments, and $2.1 billion of long-term
investments. A large portion of the cash and investments are held in foreign jurisdictions.
Working capital levels are more than adequate to meet the operating requirements of the Company.
In 2010, the Internal Revenue Service (IRS) finalized its examination of Schering-Ploughs 2003-2006 tax years. In
this audit cycle, the Company reached an agreement with the IRS on an adjustment to income related
to intercompany pricing matters. This income adjustment mostly reduced net operating losses
(NOLs) and other tax credit carryforwards. Additionally, the Company is seeking resolution of
one issue raised during this examination through the IRS administrative appeals process. The
Companys reserves for uncertain tax positions were adequate to cover all adjustments related to
this examination period. The IRS began its examination of the 2007-2009 tax years for the Company
in 2010.
In April 2011, the IRS concluded its examination of Old Mercks 2002-2005 federal income tax
returns and as a result the Company was required to make net payments
of approximately $465
million. The Companys unrecognized tax benefits for the years under examination exceed the adjustments related to
this examination period and therefore the Company anticipates that a potentially significant
non-cash favorable financial statement impact from this resolution will be recorded in the second
quarter. The Company disagrees with the IRS treatment of one issue raised during this examination
and is appealing the matter through the IRS administrative process.
As previously disclosed, the Canada Revenue Agency (CRA) has proposed adjustments for 1999
and 2000 relating to intercompany pricing matters. The adjustments would increase Canadian tax due
by approximately $325 million (U.S. dollars) plus approximately $360 million (U.S. dollars) of
interest through March 31, 2011. The Company disagrees with the positions taken by the CRA and
believes they are without merit. The Company continues to contest the assessments through the CRA
appeals process. The CRA is expected to prepare similar adjustments for later years. Management
believes that resolution of these matters will not have a material effect on the Companys
financial position or liquidity.
Capital expenditures totaled $324 million and $343 million for the first quarter of 2011 and
2010, respectively. Capital expenditures for full year 2011 are estimated to be $1.9 billion.
Dividends paid to stockholders were $1.2 billion for each of the first quarters of 2011 and
2010. In February 2011, the Board of Directors declared a quarterly dividend of $0.38 per share on
the Companys common stock for the second quarter of 2011.
In April 2011, Merck announced that its Board of Directors has approved additional purchases
of up to $5 billion of Mercks common stock for its treasury. The treasury stock purchase has no
time limit and will be made over time on the open market, in block transactions or in privately
negotiated transactions. The Company also has approximately $1.4 billion remaining under the
November 2009 treasury stock purchase authorization.
The Company has a $2.0 billion, 364-day credit facility maturing in May 2011 and a $2.0
billion credit facility maturing in August 2012. Both outstanding facilities provide backup
liquidity for the Companys commercial paper borrowing facility and are to be used for general
corporate purposes. The Company has not drawn funding from either facility.
Critical Accounting Policies
The Companys significant accounting policies, which include managements best estimates and
judgments, are included in Note 2 to the consolidated financial statements for the year ended
December 31, 2010 included in Mercks Form 10-K filed on February 28, 2011. Certain of these
accounting policies are considered critical as disclosed in the Critical Accounting Policies and
Other Matters section of Managements Discussion and Analysis of Financial Condition and Results of
Operations included in Mercks Form 10-K because of the potential for a significant impact on the
financial statements due to the inherent uncertainty in such estimates. There have been no
significant changes in the Companys critical accounting policies since December 31, 2010 other
than with respect to guidance on revenue recognition adopted on January 1, 2011 as discussed in
Note 1 to the interim consolidated financial statements.
Item 4. Controls and Procedures
Management of the Company, with the participation of its Chief Executive Officer and Chief
Financial Officer, has evaluated the effectiveness of the Companys disclosure controls and
procedures over financial reporting for the period covered by this Form 10-Q. Based on this
assessment, the Companys Chief Executive Officer and Chief Financial Officer have concluded that
as of March 31, 2011, the Companys disclosure controls and procedures are effective. As
previously disclosed, the Company is continuing its plans for integration of its business
operations and the implementation of an enterprise wide resource planning system (SAP). These
process modifications affect the design and operation of controls over financial reporting. With
each implementation, the Company monitors the status of the business and financial operations and
believes that an effective control environment has been maintained post-implementation.
- 46 -
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS
This report and other written reports and oral statements made from time to time by the
Company may contain so-called forward-looking statements, all of which are based on managements
current expectations and are subject to risks and uncertainties which may cause results to differ
materially from those set forth in the statements. One can identify these forward-looking
statements by their use of words such as anticipates, expects, plans, will, estimates,
forecasts, projects and other words of similar meaning. One can also identify them by the fact
that they do not relate strictly to historical or current facts. These statements are likely to
address the Companys growth strategy, financial results, product development, product approvals,
product potential and development programs. One must carefully consider any such statement and
should understand that many factors could cause actual results to differ materially from the
Companys forward-looking statements. These factors include inaccurate assumptions and a broad
variety of other risks and uncertainties, including some that are known and some that are not. No
forward-looking statement can be guaranteed and actual future results may vary materially.
The Company does not assume the obligation to update any forward-looking statement. One
should carefully evaluate such statements in light of factors, including risk factors, described in
the Companys filings with the Securities and Exchange Commission, especially on Forms 10-K, 10-Q
and 8-K. In Item 1A. Risk Factors of the Companys Annual Report on Form 10-K for the year ended
December 31, 2010, as filed on February 28, 2011, the Company discusses in more detail various
important risk factors that could cause actual results to differ from expected or historic results.
The Company notes these factors for investors as permitted by the Private Securities Litigation
Reform Act of 1995. One should understand that it is not possible to predict or identify all such
factors. Consequently, the reader should not consider any such list to be a complete statement of
all potential risks or uncertainties.
PART II Other Information
Item 1. Legal Proceedings
The information called for by this Item is incorporated herein by reference to Note 9 included
in Part I, Item 1, Financial Statements (unaudited) Notes to Consolidated Financial Statements.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
- 47 -
Item 6. Exhibits
|
|
|
Number |
|
Description |
3.1
|
|
Restated Certificate of Incorporation of Merck & Co., Inc. (November 3, 2009)
Incorporated by reference to Current Report on Form 8-K filed on November 4, 2009 |
|
|
|
3.2
|
|
By-Laws of Merck & Co., Inc. (effective November 3, 2009) Incorporated by reference to
Current Report on Form 8-K filed November 4, 2009 |
|
|
|
10.1
|
|
Restricted Stock Unit Terms for 2011 Grants under the Merck & Co., Inc. 2010 Incentive
Stock Plan |
|
|
|
10.2
|
|
Stock Option Terms for a Non-Qualified Stock Option (NQSO) under the Merck & Co., Inc. 2010
Incentive Stock Plan |
|
|
|
10.3
|
|
Restricted Stock Unit Terms for 2011 Grants under the Merck & Co., Inc. 2010 Incentive
Stock Plan |
|
|
|
10.4
|
|
Terms for 2011 Performance Share Units under the Merck & Co., Inc. 2010 Stock Incentive Plan |
|
|
|
31.1
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Executive Officer |
|
|
|
31.2
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Financial Officer |
|
|
|
32.1
|
|
Section 1350 Certification of Chief Executive Officer |
|
|
|
32.2
|
|
Section 1350 Certification of Chief Financial Officer |
|
|
|
101
|
|
The following materials from Merck & Co., Inc.s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2011, formatted in XBRL (Extensible
Business Reporting Language): (i) the Consolidated Statement of Income, (ii) the Consolidated Balance Sheet, (iii) the
Consolidated Statement of Cash Flow, and (iv) Notes to Consolidated Financial Statements. |
- 48 -
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
MERCK & CO., INC.
|
|
Date: May 9, 2011 |
/s/ Bruce N. Kuhlik
|
|
|
BRUCE N. KUHLIK |
|
|
Executive Vice President and General Counsel |
|
|
|
|
Date: May 9, 2011 |
/s/ John Canan
|
|
|
JOHN CANAN |
|
|
Senior Vice President Finance - Global Controller |
|
- 49 -
EXHIBIT INDEX
|
|
|
Number |
|
Description |
3.1
|
|
Restated Certificate of Incorporation of Merck & Co., Inc. (November
3, 2009) Incorporated by reference to Current Report on Form 8-K
filed on November 4, 2009 |
|
|
|
3.2
|
|
By-Laws of Merck & Co., Inc. (effective November 3, 2009)
Incorporated by reference to Current Report on Form 8-K filed November
4, 2009 |
|
|
|
10.1
|
|
Restricted
Stock Unit Terms for 2011 Grants under the Merck & Co., Inc. 2010
Incentive Stock Plan |
|
|
|
10.2
|
|
Stock Option
Terms for a Non-Qualified Stock Option (NQSO) under the Merck &
Co., Inc. 2010 Incentive Stock Plan |
|
|
|
10.3
|
|
Restricted
Stock Unit Terms for 2011 Grants under the Merck & Co., Inc. 2010
Incentive Stock Plan |
|
|
|
10.4
|
|
Terms for 2011
Performance Share Units under the Merck & Co., Inc. 2010 Stock
Incentive Plan |
|
|
|
31.1
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Executive Officer |
|
|
|
31.2
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Financial Officer |
|
|
|
32.1
|
|
Section 1350 Certification of Chief Executive Officer |
|
|
|
32.2
|
|
Section 1350 Certification of Chief Financial Officer |
|
|
|
101
|
|
The following materials from Merck & Co., Inc.s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2011, formatted in XBRL
(Extensible Business Reporting Language): (i) the Consolidated
Statement of Income, (ii) the Consolidated Balance Sheet, (iii) the
Consolidated Statement of Cash Flow, and (iv) Notes to Consolidated
Financial Statements. |
- 50 -