10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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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, 2008
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. 1-3305
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. 22-1109110 |
The number of shares of common stock outstanding as of the close of business on March 31, 2008:
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Class |
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Number of Shares Outstanding |
Common Stock
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2,146,528,024 |
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 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
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Non-accelerated filer
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(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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2008 |
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2007 |
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Sales |
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$ |
5,822.1 |
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$ |
5,769.4 |
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Costs, Expenses and Other
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Materials and production |
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1,238.1 |
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1,525.8 |
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Marketing and administrative |
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1,854.4 |
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1,802.0 |
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Research and development |
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1,078.3 |
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1,030.0 |
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Restructuring costs |
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69.7 |
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65.8 |
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Equity income from affiliates |
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(652.1 |
) |
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(652.6 |
) |
Other (income) expense, net |
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(2,177.3 |
) |
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(256.0 |
) |
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1,411.1 |
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3,515.0 |
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Income Before Taxes |
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4,411.0 |
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2,254.4 |
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Taxes on Income |
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1,108.4 |
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550.1 |
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Net Income |
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$ |
3,302.6 |
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$ |
1,704.3 |
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Basic Earnings per Common Share |
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$ |
1.53 |
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$ |
0.79 |
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Earnings per Common Share Assuming Dilution |
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$ |
1.52 |
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$ |
0.78 |
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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)
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March 31, |
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December 31, |
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2008 |
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2007 |
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Assets |
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Current Assets
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Cash and cash equivalents |
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$ |
6,289.4 |
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$ |
5,336.1 |
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Short-term investments |
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2,874.3 |
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2,894.7 |
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Accounts receivable |
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3,760.8 |
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3,636.2 |
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Inventories (excludes inventories of $366.4 in 2008 and $345.2
in 2007 classified in Other assets see Note 4) |
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2,076.5 |
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1,881.0 |
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Prepaid expenses and taxes |
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2,046.0 |
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1,297.4 |
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Total current assets |
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17,047.0 |
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15,045.4 |
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Investments |
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6,909.1 |
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7,159.2 |
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Property, Plant and Equipment, at cost, net of allowance for
depreciation of $11,728.2 in 2008 and $12,457.1 in 2007 |
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12,290.9 |
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12,346.0 |
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Goodwill |
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1,454.8 |
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1,454.8 |
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Other Intangibles, Net |
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653.8 |
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713.2 |
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Other Assets |
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8,685.5 |
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11,632.1 |
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$ |
47,041.1 |
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$ |
48,350.7 |
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Liabilities and Stockholders Equity |
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Current Liabilities
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Loans payable and current portion of long-term debt |
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$ |
421.5 |
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$ |
1,823.6 |
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Trade accounts payable |
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626.9 |
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624.5 |
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Accrued and other current liabilities |
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6,580.5 |
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8,534.9 |
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Income taxes payable |
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1,346.3 |
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444.1 |
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Dividends payable |
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821.8 |
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831.1 |
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Total current liabilities |
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9,797.0 |
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12,258.2 |
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Long-Term Debt |
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3,965.0 |
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3,915.8 |
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Deferred Income Taxes and Noncurrent Liabilities |
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11,320.2 |
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11,585.3 |
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Minority Interests |
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2,437.4 |
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2,406.7 |
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Stockholders Equity |
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Common stock, one cent par value
Authorized - 5,400,000,000 shares
Issued - 2,983,508,675 shares |
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29.8 |
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29.8 |
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Other paid-in capital |
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8,076.5 |
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8,014.9 |
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Retained earnings |
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41,622.0 |
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39,140.8 |
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Accumulated other comprehensive loss |
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(764.4 |
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(826.1 |
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48,963.9 |
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46,359.4 |
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Less treasury stock, at cost |
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836,980,651 shares at March 31, 2008 |
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811,005,791 shares at December 31, 2007 |
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29,442.4 |
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28,174.7 |
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Total stockholders equity |
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19,521.5 |
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18,184.7 |
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$ |
47,041.1 |
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$ |
48,350.7 |
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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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2008 |
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2007 |
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Cash Flows from Operating Activities |
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Net income |
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$ |
3,302.6 |
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$ |
1,704.3 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Gain on distribution from AstraZeneca LP |
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(2,222.7 |
) |
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Equity income from affiliates |
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(652.1 |
) |
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(652.6 |
) |
Dividends and distributions from equity affiliates |
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2,669.8 |
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440.3 |
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Depreciation and amortization |
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391.1 |
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500.4 |
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Deferred income taxes |
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(227.4 |
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40.9 |
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Share-based compensation |
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91.0 |
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97.0 |
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Other |
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(82.0 |
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(28.3 |
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Taxes paid for Internal Revenue Service settlement |
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(2,788.1 |
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Net changes in assets and liabilities |
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(742.0 |
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(642.8 |
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Net Cash Provided by (Used by) Operating Activities |
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2,528.3 |
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(1,328.9 |
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Cash Flows from Investing Activities |
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Capital expenditures |
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(341.4 |
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(200.7 |
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Purchases of securities and other investments |
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(3,088.4 |
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(3,005.1 |
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Acquisitions of subsidiaries, net of cash acquired |
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(1,134.0 |
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Proceeds from sales of securities and other investments |
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3,269.4 |
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3,880.9 |
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Distribution from AstraZeneca LP |
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1,899.3 |
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Decrease (increase) in restricted assets |
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167.9 |
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(820.0 |
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Other |
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(4.0 |
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(2.5 |
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Net Cash Provided by (Used by) Investing Activities |
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1,902.8 |
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(1,281.4 |
) |
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Cash Flows from Financing Activities |
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Net change in short-term borrowings |
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(22.6 |
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497.2 |
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Payments on debt |
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(1,382.6 |
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(854.8 |
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Purchases of treasury stock |
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(1,377.8 |
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(244.4 |
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Dividends paid to stockholders |
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(830.8 |
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(826.6 |
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Proceeds from exercise of stock options |
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79.7 |
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44.9 |
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Other |
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(49.5 |
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167.4 |
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Net Cash Used by Financing Activities |
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(3,583.6 |
) |
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(1,216.3 |
) |
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Effect of Exchange Rate Changes on Cash and Cash Equivalents |
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105.8 |
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13.8 |
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Net Increase (Decrease) in Cash and Cash Equivalents |
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953.3 |
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(3,812.8 |
) |
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Cash and Cash Equivalents at Beginning of Year |
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5,336.1 |
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5,914.7 |
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Cash and Cash Equivalents at End of Period |
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$ |
6,289.4 |
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$ |
2,101.9 |
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The accompanying notes are an integral part of this consolidated financial statement.
- 4 -
Notes to Consolidated Financial Statements (unaudited)
1. |
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Basis of Presentation |
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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 financial statements and notes thereto included in the
Companys latest Annual Report on Form 10-K. |
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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. |
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On January 1, 2008, the Company adopted Financial Accounting Standards Board (FASB) Statement
No. 157, Fair Value Measurements (FAS 157), which clarifies the definition of fair value,
establishes a framework for measuring fair value, and expands the disclosures on fair value
measurements. In February 2008, the FASB issued Staff Position 157-2, Effective Date of FASB
Statement No. 157 (FSP 157-2), that deferred the effective date of FAS 157 for one year for
nonfinancial assets and liabilities recorded at fair value on a non-recurring basis. The effect
of adoption of FAS 157 for financial assets and liabilities recognized at fair value on a
recurring basis did not have a material impact on the Companys financial position and results
of operations (see Note 3). The Company is assessing the impact of FAS 157 for nonfinancial
assets and liabilities. |
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On January 1, 2008, the Company adopted Emerging Issues Task Force (EITF) Issue No. 07-3,
Accounting for Advance Payments for Goods or Services Received for Use in Future Research and
Development Activities (EITF 07-3), which is being applied prospectively for new contracts.
EITF 07-3 addresses nonrefundable advance payments for goods or services that will be used or
rendered for future research and development activities. EITF 07-3 requires these payments be
deferred and capitalized and recognized as an expense as the related goods are delivered or the
related services are performed. The effect of adoption of EITF 07-3 on the Companys financial
position and results of operations was not material. |
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On January 1, 2008, the Company adopted FASB Statement No. 159, The Fair Value Option for
Financial Assets and Financial Liabilities, including an amendment of FASB Statement No. 115
(FAS 159). FAS 159 permits companies to choose an irrevocable election to measure certain
financial assets and financial liabilities at fair value. Unrealized gains and losses on items
for which the fair value option has been elected are reported in earnings at each subsequent
reporting date. The Company did not elect the fair value option under FAS 159 for any of its
financial assets or liabilities upon adoption. |
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In December 2007, the FASB issued Statements No. 141R, Business Combinations (FAS 141R), and
No. 160, Noncontrolling Interests in Consolidated Financial Statementsan amendment of ARB No.
51 (FAS 160). FAS 141R expands the scope of acquisition accounting to all transactions under
which control of a business is obtained. Among other things, FAS 141R requires that contingent
consideration as well as contingent assets and liabilities be recorded at fair value on the
acquisition date, that acquired in-process research and development be capitalized and recorded
as intangible assets at the acquisition date, and also requires transaction costs and costs to
restructure the acquired company be expensed. FAS 160 requires, among other things, that
noncontrolling interests be recorded as equity in the consolidated financial statements. FAS
141R and FAS 160 are both effective, on a prospective basis, January 1, 2009 with the exception
of the presentation and disclosure requirements of FAS 160 which must be applied
retrospectively. The Company is assessing the impacts of these standards on its financial
position and results of operations. |
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In December 2007, the FASB ratified the consensus reached by the EITF on Issue No. 07-1 (EITF
07-1), Accounting for Collaborative Arrangements. EITF 07-1 is effective for the Company
beginning January 1, 2009 and will be applied retrospectively to all prior periods presented for
all collaborative arrangements existing as of the effective date. EITF 07-1 defines
collaborative arrangements and establishes reporting requirements for transactions between
participants in a collaborative arrangement and between participants in the arrangement and
third parties. The Company is assessing the impact of adoption of EITF 07-1 on its financial
position and results of operations. |
- 5 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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In March 2008, the FASB issued Statement No. 161, Disclosures about Derivative Instruments and
Hedging Activities (FAS 161), which is effective January 1, 2009. FAS 161 requires enhanced
disclosures about derivative instruments and hedging activities to allow for a better
understanding of their effects on an entitys financial position, financial performance, and
cash flows. Among other things, FAS 161 requires disclosure of the fair values of derivative
instruments and associated gains and losses in a tabular format. Since FAS 161 requires only
additional disclosures about the Companys derivatives and hedging activities, the adoption of
FAS 161 will not affect the Companys financial position or results of operations. |
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2. |
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Restructuring |
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In November 2005, the Company announced the initial phase of its global restructuring program
designed to reduce the Companys cost structure, increase efficiency and enhance
competitiveness. As part of this program, as of March 31, 2008, Merck has sold or closed five
manufacturing sites and two preclinical sites. The Company also has, and may continue to, sell
or close certain other facilities and related assets in connection with the restructuring
program. As of March 31, 2008, the Company has eliminated approximately 8,100 positions
company-wide and will continue to identify opportunities for further headcount reductions. The
Company, however, continues to hire new employees as the business requires. Through the end of
2008, when the initial phase of the global restructuring program is expected to be substantially
complete, the cumulative pretax costs of the program are expected to be approximately $2.2
billion to $2.4 billion. Approximately 70% of the cumulative pretax costs are non-cash,
relating primarily to accelerated depreciation for facilities closed or scheduled for closure.
Since the inception of the global restructuring program through March 31, 2008, the Company has
recorded total pretax accumulated costs of $2.2 billion. For segment reporting purposes,
restructuring charges are unallocated expenses. |
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The following table summarizes the charges related to restructuring activities by type of cost: |
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Three Months Ended March 31, |
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2008 |
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2007 |
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Separation |
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Accelerated |
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Separation |
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Accelerated |
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($ 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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Costs |
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Depreciation |
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Other |
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Total |
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Materials and production |
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$ |
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$ |
15.3 |
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$ |
(0.4 |
) |
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$ |
14.9 |
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$ |
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$ |
118.1 |
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$ |
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$ |
118.1 |
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Research and development |
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2.3 |
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(0.1 |
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2.2 |
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Restructuring costs |
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101.4 |
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(31.7 |
) |
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69.7 |
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46.9 |
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18.9 |
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65.8 |
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$ |
101.4 |
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$ |
15.3 |
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$ |
(32.1 |
) |
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$ |
84.6 |
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|
$ |
46.9 |
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$ |
120.4 |
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$ |
18.8 |
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$ |
186.1 |
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Separation costs are associated with actual headcount reductions, as well as those headcount
reductions that were probable and could be reasonably estimated. In the first quarter of 2008,
approximately 900 positions were eliminated and in the first quarter of 2007 approximately 230
positions were eliminated.
Accelerated depreciation costs primarily relate to manufacturing facilities sold or closed as
part of the program.
Other activity of $(32.1) million for the first quarter of 2008 reflects pretax gains of $47.8
million resulting from the sales of facilities and related assets, partially offset by costs
that include termination charges associated with the Companys pension and other postretirement
benefit plans (see Note 9), shut-down and other related costs, as well as asset impairments.
Other activity of $18.8 million for the first quarter of 2007 reflects benefit plan termination
charges, as well as asset impairments.
The following table summarizes the charges and spending relating to restructuring activities for
the three months ended March 31, 2008:
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Separation |
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Accelerated |
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($ in millions) |
|
Costs |
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Depreciation |
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Other |
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Total |
|
Restructuring reserves as of January 1, 2008 |
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$ |
231.5 |
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$ |
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$ |
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$ |
231.5 |
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Expense |
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|
101.4 |
|
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|
15.3 |
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|
(32.1 |
) |
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|
84.6 |
|
(Payments) receipts, net |
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|
(91.5 |
) |
|
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|
35.5 |
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(56.0 |
) |
Non-cash activity |
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(15.3 |
) |
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(3.4 |
) |
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(18.7 |
) |
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Restructuring reserves as of March 31, 2008 (1) |
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$ |
241.4 |
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$ |
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|
$ |
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$ |
241.4 |
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(1) |
|
The cash outlays associated with the remaining restructuring reserve are
expected to be largely completed by the end of 2009. |
- 6 -
Notes to Consolidated Financial Statements (unaudited) (continued)
3. |
|
Fair Value Measurements |
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|
|
On January 1, 2008, the Company adopted FAS 157, which clarifies the definition of fair value,
establishes a framework for measuring fair value, and expands the disclosures on fair value
measurements. In February 2008, the FASB issued FSP 157-2 that deferred the effective date of
FAS 157 for one year for nonfinancial assets and liabilities recorded at fair value on a
non-recurring basis. FAS 157 defines fair value 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. FAS 157 also establishes a fair value hierarchy which
requires an entity to maximize the use of observable inputs and minimize the use of unobservable
inputs when measuring fair value. FAS 157 describes 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 short-term investments in time deposits and 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, and derivative contracts whose value is determined using a pricing model 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 value is 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 mainly include
mortgage-backed and asset-backed securities, as well as certain corporate notes and bonds with
limited market activity. At March 31, 2008, approximately $161.2 million, or approximately
1.5%, of the Companys investment securities were categorized as Level 3 fair value assets (all
of which were pledged under certain collateral arrangements (see Note 11)). |
|
|
|
If the inputs used to measure the financial assets and liabilities fall within the different
levels described above, the categorization is based on the lowest level input that is
significant to the fair value measurement of the instrument. |
|
|
|
Financial assets and liabilities measured at fair value on a recurring basis as of March 31,
2008 are summarized below: |
- 7 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using |
|
|
Quoted Prices |
|
Significant |
|
|
|
|
|
|
In Active |
|
Other |
|
Significant |
|
|
|
|
Markets for |
|
Observable |
|
Unobservable |
|
|
|
|
Identical Assets |
|
Inputs |
|
Inputs |
|
|
($ in millions) |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
|
Total |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate notes and bonds |
|
$ |
|
|
|
$ |
5,404.8 |
|
|
$ |
|
|
|
$ |
5,404.8 |
|
U.S. government and agency securities |
|
|
|
|
|
|
1,890.8 |
|
|
|
|
|
|
|
1,890.8 |
|
Municipal securities |
|
|
|
|
|
|
761.7 |
|
|
|
|
|
|
|
761.7 |
|
Mortgage-backed securities (1) |
|
|
|
|
|
|
717.4 |
|
|
|
|
|
|
|
717.4 |
|
Asset-backed securities (2) |
|
|
|
|
|
|
366.6 |
|
|
|
|
|
|
|
366.6 |
|
Foreign government bonds |
|
|
|
|
|
|
366.3 |
|
|
|
|
|
|
|
366.3 |
|
Time deposits |
|
|
118.6 |
|
|
|
|
|
|
|
|
|
|
|
118.6 |
|
Equity securities |
|
|
61.8 |
|
|
|
90.7 |
|
|
|
|
|
|
|
152.5 |
|
Other debt securities |
|
|
|
|
|
|
4.7 |
|
|
|
|
|
|
|
4.7 |
|
|
Total investments |
|
$ |
180.4 |
|
|
$ |
9,603.0 |
|
|
$ |
|
|
|
$ |
9,783.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets (3) |
|
$ |
|
|
|
$ |
896.9 |
|
|
$ |
161.2 |
|
|
$ |
1,058.1 |
|
Derivative assets |
|
|
|
|
|
|
223.7 |
|
|
|
|
|
|
|
223.7 |
|
|
Total Assets |
|
$ |
180.4 |
|
|
$ |
10,723.6 |
|
|
$ |
161.2 |
|
|
$ |
11,065.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative liabilities |
|
$ |
|
|
|
$ |
168.8 |
|
|
$ |
|
|
|
$ |
168.8 |
|
|
|
|
|
|
|
(1) |
|
Represents AAA-rated mortgage-backed securities issued or unconditionally
guaranteed as to payment of principal and interest by U.S. government agencies. |
|
|
(2) |
|
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. |
|
|
(3) |
|
These investment securities represent a portion of the pledged collateral
discussed in Note 11. |
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. Level 3 investment securities primarily
include mortgage-backed and asset-backed securities, as well as certain corporate notes and
bonds for which there was a decrease in the observability of
market pricing for these investments. At March 31, 2008, these securities were valued primarily
using broker pricing models that 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 at March 31, 2008.
The table below provides a summary of the changes in fair value, including net transfers in
and/or out, of all financial assets measured at fair value on a recurring basis using
significant unobservable inputs (Level 3) for the period January 1, 2008 to March 31, 2008.
- 8 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Realized and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized Losses |
|
|
|
|
|
|
Losses Recorded |
|
|
|
|
|
|
Net |
|
Purchases, |
|
Included in: |
|
|
|
|
|
|
in Earnings for |
|
|
|
|
|
|
Transfers |
|
Sales, |
|
|
|
|
|
Compre- |
|
|
|
|
|
|
Level 3 Assets |
|
|
Beginning |
|
(Out) of |
|
Settlements, |
|
|
|
|
|
hensive |
|
Ending |
|
|
Still Held at |
($ in millions) |
|
Balance |
|
Level 3 |
|
net |
|
Earnings (1) |
|
Income |
|
Balance |
|
|
March 31, 2008 |
|
|
|
|
Other assets |
|
$ |
958.6 |
|
|
$ |
(785.2 |
) |
|
$ |
(8.8 |
) |
|
$ |
(2.3 |
) |
|
$ |
(1.1 |
) |
|
$ |
161.2 |
|
|
|
$ |
(2.3 |
) |
Other debt securities |
|
|
314.5 |
|
|
|
(314.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,273.1 |
|
|
$ |
(1,099.7 |
) |
|
$ |
(8.8 |
) |
|
$ |
(2.3 |
) |
|
$ |
(1.1 |
) |
|
$ |
161.2 |
|
|
|
$ |
(2.3 |
) |
|
|
|
|
|
|
|
|
|
(1) |
|
Amounts are recorded in Other (income) expense, net, in the Consolidated
Statement of Income. |
|
|
On January 1, 2008, the Company had $1,273.1 million invested in a short-term fixed income fund
(the Fund). Due to market liquidity conditions, cash redemptions from the Fund were
restricted. As a result of this restriction on cash redemptions, the Company did not consider
the Fund to be traded in an active market with observable pricing on January 1, 2008 and these
amounts were categorized as Level 3. On January 7, 2008, the Company elected to be
redeemed-in-kind from the Fund and received its share of the
underlying securities of the Fund. As a result,
$1,099.7 million of the underlying securities were transferred out of Level 3 as it was
determined these securities had observable markets.
On March 31, 2008, $161.2 million of the investment securities associated with the
redemption-in-kind remained classified in Level 3 as the securities contained at least one
significant input which was unobservable. |
|
4. |
|
Inventories |
|
|
|
Inventories consisted of: |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Finished goods |
|
$ |
421.8 |
|
|
$ |
382.9 |
|
Raw materials and work in process |
|
|
1,900.8 |
|
|
|
1,732.2 |
|
Supplies |
|
|
120.3 |
|
|
|
111.1 |
|
|
Total (approximates current cost) |
|
|
2,442.9 |
|
|
|
2,226.2 |
|
Reduction to LIFO cost for domestic inventories |
|
|
|
|
|
|
|
|
|
|
|
$ |
2,442.9 |
|
|
$ |
2,226.2 |
|
|
Recognized as: |
|
|
|
|
|
|
|
|
Inventories |
|
$ |
2,076.5 |
|
|
$ |
1,881.0 |
|
Other assets |
|
$ |
366.4 |
|
|
$ |
345.2 |
|
|
|
|
Amounts recognized as Other assets are comprised entirely of raw materials and work in process
inventories, representing inventories for products not expected to be sold within one year, the
majority of which are vaccines. |
|
5. |
|
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) |
|
2008 |
|
2007 |
|
Merck/Schering-Plough |
|
$ |
392.8 |
|
|
$ |
347.2 |
|
AstraZeneca LP |
|
|
131.1 |
|
|
|
211.9 |
|
Other (1) |
|
|
128.2 |
|
|
|
93.5 |
|
|
|
|
$ |
652.1 |
|
|
$ |
652.6 |
|
|
|
|
|
|
|
(1) |
|
Primarily reflects results from Merial Limited, Sanofi Pasteur MSD and Johnson &
Johnson°Merck Consumer Pharmaceuticals Company. |
- 9 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Merck/Schering-Plough
In 2000, the Company and Schering-Plough Corporation (Schering-Plough) (collectively the
Partners) entered into agreements to create separate equally-owned partnerships to develop and
market in the United States new prescription medicines in the cholesterol-management and
respiratory therapeutic areas. These agreements generally provide for equal sharing of
development costs and for co-promotion of approved products by each company. In 2001, the
cholesterol-management partnership agreements were expanded to include all the countries of the
world, excluding Japan. In 2002, ezetimibe, the first in a new class of cholesterol-lowering
agents, was launched in the United States as Zetia (marketed as Ezetrol outside the United
States). In 2004, a combination product containing the active ingredients of both Zetia and
Zocor was approved in the United States as Vytorin (marketed as Inegy outside of the United
States).
The cholesterol agreements provide for the sharing of operating income generated by the
Merck/Schering-Plough cholesterol partnership (the MSP Partnership) based upon percentages
that vary by product, sales level and country. In the U.S. market, the Partners share profits
on Zetia and Vytorin sales equally, with the exception of the first $300 million of annual Zetia
sales on which Schering-Plough receives a greater share of profits. Operating income includes
expenses that the Partners have contractually agreed to share, such as a portion of
manufacturing costs, specifically identified promotion costs (including direct-to-consumer
advertising and direct and identifiable out-of-pocket promotion) and other agreed upon costs for
specific services such as on-going clinical research, market support, market research, market
expansion, as well as a specialty sales force and physician education programs. Expenses
incurred in support of the MSP Partnership but not shared between the Partners, such as
marketing and administrative expenses (including certain sales force costs), as well as certain
manufacturing costs, are not included in Equity income from affiliates. However, these costs
are reflected in the overall results of the Company. Certain research and development expenses
are generally shared equally by the Partners, after adjusting for earned milestones.
See Note 7 for information with respect to litigation involving the MSP Partnership and the
Partners related to the sale and promotion of Zetia and Vytorin.
The respiratory therapeutic agreements provide for the joint development and marketing in the
United States by the Partners of a once-daily, fixed-combination tablet containing the active
ingredients montelukast sodium and loratadine. Montelukast sodium, a leukotriene receptor
antagonist, is sold by Merck as Singulair and loratadine, an antihistamine, is sold by
Schering-Plough as Claritin, both of which are indicated for the relief of symptoms of allergic
rhinitis. On April 25, 2008, the Partners announced that they had received a not-approvable
letter from the U.S. Food and Drug Administration (FDA) for the proposed fixed combination of
loratadine/montelukast. The Partners are evaluating the FDAs response.
Summarized financial information for the MSP Partnership is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Sales |
|
$ |
1,232.9 |
|
|
$ |
1,167.8 |
|
|
Vytorin |
|
|
651.2 |
|
|
|
623.8 |
|
Zetia |
|
|
581.7 |
|
|
|
544.0 |
|
|
Materials and production costs |
|
|
52.4 |
|
|
|
50.0 |
|
Other expense, net |
|
|
326.8 |
|
|
|
322.6 |
|
|
Income before taxes |
|
$ |
853.7 |
|
|
$ |
795.2 |
|
|
|
|
|
|
|
|
|
|
|
Mercks share of income before taxes (1) |
|
$ |
394.6 |
|
|
$ |
362.5 |
|
|
|
|
|
|
|
(1) |
|
Mercks share of the MSP Partnerships income before taxes differs from the
equity income recognized from the MSP Partnership primarily due to the timing of
recognition of certain transactions between the Company and the MSP Partnership. |
AstraZeneca LP
As previously disclosed, the 1999 AstraZeneca merger triggered a partial redemption in March
2008 of Mercks limited partnership interest in AstraZeneca LP (AZLP). Upon this redemption,
Merck received $4.3 billion from AZLP. This amount was based primarily on a multiple of Mercks
average annual variable returns derived from sales of the former
- 10 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Astra USA, Inc. products for
the three years prior to the redemption (the Limited Partner Share of Agreed Value). Merck
recorded a $1.5 billion pretax gain on the partial redemption.
Also, as a result of the 1999 AstraZeneca merger, in exchange for Mercks relinquishment of
rights to future Astra products with no existing or pending U.S. patents at the time of the
merger, Astra paid $967.4 million (the Advance Payment). The Advance Payment was deferred as
it remained subject to a true-up calculation that was directly dependent on the fair market
value in March 2008 of the Astra product rights retained by the Company. The calculated True-Up
Amount of $243.7 million was returned to AZLP in March 2008 and Merck recognized a pretax gain
of $723.7 million related to the residual Advance Payment balance.
In 1998, Astra purchased an option (the Asset Option) to buy Mercks interest in the KBI
products, excluding the gastrointestinal medicines Nexium and Prilosec (the Non-PPI Products),
for a payment of $443.0 million, which was deferred. The Asset Option is exercisable in the
first half of 2010 at an exercise price equal to the net present value as of March 31, 2008 of
projected future pretax revenue to be received by the Company from the Non-PPI Products (the
Appraised Value). Merck also had the right to require Astra to purchase such interest in 2008
at the Appraised Value. In February 2008, the Company advised AZLP that it would not exercise
the Asset Option, thus the $443.0 million remains deferred.
The sum of the Limited Partner Share of Agreed Value, the Appraised Value and the True-Up Amount
was guaranteed to be a minimum of $4.7 billion. Distribution of the Limited Partner Share of
Agreed Value less payment of the True-Up Amount resulted in cash receipts to Merck of $4.0
billion and an aggregate pretax gain of $2.2 billion which is included in Other (income)
expense, net. AstraZenecas purchase of Mercks interest in the Non-PPI Products is contingent
upon the exercise of the Asset Option by AstraZeneca in 2010 and, therefore, payment of
the Appraised Value may or may not occur. Also, in March 2008, the outstanding loan from Astra
in the amount of $1.38 billion plus interest through the redemption date was settled. As a
result of these transactions, the Company received net proceeds from AZLP of $2.6 billion in the
first quarter of 2008.
Summarized financial information for AZLP is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Sales |
|
$ |
1,326.8 |
|
|
$ |
1,704.0 |
|
Materials and production costs |
|
|
696.3 |
|
|
|
1,012.5 |
|
Other expense, net |
|
|
384.7 |
|
|
|
273.7 |
|
|
Income before taxes |
|
$ |
245.8 |
|
|
$ |
417.8 |
|
|
6. |
|
Debt and Financial Instruments |
|
|
|
In January and February 2008, the Company terminated four interest rate swap contracts with
notional amounts of $250 million each, which effectively converted its $1.0 billion, 4.75%
fixed-rate notes due 2015 to variable rate debt. As a result of the swap terminations, the
Company received $96.2 million in cash excluding accrued interest which was not material. The
corresponding gains related to the basis adjustment of the debt associated with the terminated
swap contracts were deferred and are being amortized as a reduction of interest expense over the
remaining term of the notes. The cash flows from these contracts are reported as operating
activities in the Consolidated Statement of Cash Flows. |
|
|
|
In March 2008, the Company entered into a
$4.1 billion letter of credit agreement with a financial institution, which
provides that if participation conditions under the U.S. Vioxx
Settlement Agreement (see Note 7) are met
or waived, a letter of credit will be executed and the Company will pledge collateral to the
financial institution of approximately $5.0 billion pursuant to the terms of the agreement. The
letter of credit will satisfy certain conditions stipulated by the Settlement Agreement. The letter of
credit amount and required collateral balances will decline as payments (after the first $750
million) under the Settlement Agreement are made. |
|
|
|
Also in March 2008, the Company settled the $1.38 billion Astra Note due in 2008 (see Note 5). |
- 11 -
Notes to Consolidated Financial Statements (unaudited) (continued)
7. |
|
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 the
Company 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 New Jersey, California and
Texas, and the counties of Philadelphia, Pennsylvania and Washoe and Clark Counties, Nevada. As
of March 31, 2008, the Company had been served or was aware that it had been named as a
defendant in approximately 14,450 lawsuits, which include approximately 32,925 plaintiff groups,
alleging personal injuries resulting from the use of Vioxx, and in approximately 260 putative
class actions alleging personal injuries and/or economic loss. (All of the actions discussed in
this paragraph are collectively referred to as the Vioxx Product Liability Lawsuits.) Of these
lawsuits, approximately 9,200 lawsuits representing approximately 24,325 plaintiff groups are or
are slated to be in the federal MDL and approximately 3,350 lawsuits representing approximately
3,350 plaintiff groups are included in a coordinated proceeding in New Jersey Superior Court
before Judge Carol E. Higbee. |
|
|
|
In addition to the Vioxx Product Liability Lawsuits discussed above, the claims of over 21,000
plaintiffs had been dismissed as of March 31, 2008. Of these, there have been over 2,250
plaintiffs whose claims were dismissed with prejudice (i.e., they cannot be brought again)
either by plaintiffs themselves or by the courts. Over 18,750 additional plaintiffs have had
their claims dismissed without prejudice (i.e., subject to the applicable statute of
limitations, they can be brought again). Of these, 11,800 plaintiff groups represent plaintiffs
who had lawsuits pending in the New Jersey Superior Court at the time of the Settlement
Agreement described below and who have expressed an intent to enter the program established by
the Settlement Agreement; Judge Higbee has dismissed these cases without prejudice for
administrative reasons. |
|
|
|
Merck entered into a tolling agreement (the Tolling Agreement) with the MDL Plaintiffs
Steering Committee (PSC) that established a procedure to halt the running of the statute of
limitations (tolling) as to certain categories of claims allegedly arising from the use of Vioxx
by non-New Jersey citizens. The Tolling Agreement applied to individuals who have not filed
lawsuits and may or may not eventually file lawsuits and only to those claimants who seek to
toll claims alleging injuries resulting from a thrombotic cardiovascular event that results in a
myocardial infarction (MI) or ischemic stroke (IS). The Tolling Agreement provided counsel
additional time to evaluate potential claims. The Tolling Agreement required any tolled claims
to be filed in federal court. As of March 31, 2008, approximately 12,760 claimants had entered
into Tolling Agreements. The parties agreed that April 9, 2007 was the deadline for filing
Tolling Agreements and no additional Tolling Agreements are being accepted. |
|
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On November 9, 2007, Merck announced that it had entered into an agreement (the Settlement
Agreement) with the law firms that comprise the executive committee of the PSC of the federal
Vioxx MDL as well as representatives of plaintiffs counsel in the Texas, New Jersey and
California state coordinated proceedings to resolve state and federal MI and IS claims filed as
of that date in the United States. The Settlement Agreement, which also applies to tolled
claims, was signed by the parties after several meetings with three of the four judges
overseeing the coordination of more than 95 percent of the U.S. Vioxx
Product Liability Lawsuits. The Settlement Agreement applies only to U.S. legal residents and those who allege
that their MI or IS occurred in the United States. |
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If certain participation conditions under the Settlement Agreement are met, which conditions may
be waived by Merck, Merck will pay a fixed aggregate amount of $4.85 billion into two funds for
qualifying claims that enter into the resolution process (the Settlement Program). Individual
claimants will be examined by administrators of the Settlement Program to determine
qualification based on objective, documented facts provided by claimants, including records
sufficient for a scientific evaluation of independent risk factors. The conditions in the
Settlement Agreement also require claimants to pass three gates: an injury gate requiring
objective, medical proof of an MI or IS (each as defined in the Settlement Agreement), a
duration gate based on documented receipt of at least 30 Vioxx pills, and a proximity gate
requiring receipt of pills in sufficient number and proximity to the event to support a
presumption of ingestion of Vioxx within 14 days before the claimed injury. |
- 12 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The Settlement Agreement
provides that Merck does not admit causation or fault. Mercks payment
obligations under the Settlement Agreement will be triggered only if, among other conditions,
(1) law firms on the federal and state
PSCs and firms that have tried cases in the coordinated proceedings elect to recommend
enrollment in the program to 100 percent of their clients who allege either MI or IS and (2) by
June 30, 2008, plaintiffs enroll in the Settlement Program at least 85
percent of each of all currently pending and tolled (i) MI claims, (ii) IS claims, (iii)
eligible MI and IS claims together which involve death, and (iv) eligible MI and IS claims
together which allege more than 12 months of use. The Company has the right to waive these
participation conditions.
Under the Settlement Agreement,
Merck will create separate funds in the amount of $4.0 billion
for MI claims and $850 million for IS claims. Once triggered, Mercks total payment for both
funds of $4.85 billion is a fixed amount to be allocated among qualifying claimants based on
their individual evaluation. While at this time the exact number of claimants covered by the
Settlement Agreement is unknown, the total dollar amount is fixed. Payments to individual
qualifying claimants could begin as early as August 2008 and then will be paid over a period of
time. Merck retains its right to terminate this process without any payment to any claimant, and
to defend each claim individually at trial if any of the aforementioned participation conditions
in the Settlement Agreement are not met or waived.
After the Settlement Agreement was announced on November 9, 2007, judges in the Federal MDL,
California, Texas and New Jersey State Coordinated Proceedings entered a series of orders. The
orders: (1) temporarily stayed their respective litigations; (2) required plaintiffs to register
their claims by January 15, 2008; (3) require plaintiffs with cases pending as of November 9,
2007 to preserve and produce records and serve expert reports; and (4) require plaintiffs who
file thereafter to make similar productions on an accelerated schedule. The Clark County, Nevada
and Washoe County, Nevada coordinated proceedings were also generally stayed.
As of March 31, 2008, more than 45,000 of the approximately 47,500 individuals who registered
eligible injuries have submitted some or all of the materials required for enrollment in the
program to resolve state and federal MI and IS claims filed against the Company in the United
States. If all of these eligible submissions are completed in accordance with the Settlement
Agreement, this would represent more than 94 percent of the eligible MI and IS claims previously
registered with the program. In addition, approximately 5,500 other claimants have also sought
to enroll and their eligibility status still has yet to be determined.
Also, as of March 31, BrownGreer, the claims administrator for the Settlement Program (the
Claims Administrator), reports that more than 28,250 eligible MI claimants have initiated
enrollment and more than 16,750 eligible IS claimants have initiated enrollment. Of these, more
than 5,500 eligible MI and IS claimants alleging death as an injury have initiated enrollment
and more than 27,500 eligible MI and IS claimants alleging more than 12 months of use have
initiated enrollment. Each of these numbers appears to represent at least 94.5 percent of the
eligible claims in each category. These numbers do not include the additional 5,500 enrollees
whose eligibility has yet to be determined.
On April 14, 2008, various private insurance companies and health plans filed suit against
BrownGreer and U.S. Bancorp, escrow agent for the Settlement Program. The private insurance
companies and health plans claim to have paid healthcare costs on behalf of some of the
enrolling claimants and seek to enjoin the Claims Administrator from paying enrolled claimants
until their claims for reimbursement from the enrolled claimants are resolved.
The registration and enrollment materials currently are being evaluated for eligibility,
accuracy and completeness. The Claims Administrator continues to receive new materials from
plaintiffs. The Company is confident that all 85% thresholds under the Settlement Agreement
will be met and exceeded within the time frames in the Settlement Agreement.
The Company has previously disclosed the outcomes of several Vioxx Product Liability Lawsuits
that were tried prior to January 1, 2008.
The following sets forth certain significant rulings that occurred in or after the first quarter
of 2008 with respect to the Vioxx Product Liability Lawsuits.
On April 19, 2007, Judge Randy Wilson, who presides over the Texas Vioxx coordinated proceeding,
dismissed the failure to warn claim of plaintiff Ruby Ledbetter, whose case was scheduled to be
tried on May 14, 2007. Judge Wilson relied on a Texas statute enacted in 2003 that provides
that there can be no failure to warn regarding a prescription medicine if the medicine is
distributed with FDA approved labeling. There is an exception in the statute if required,
material, and relevant information was withheld from the FDA that would have led to a different
decision
- 13 -
Notes to Consolidated Financial Statements (unaudited) (continued)
regarding the approved labeling, but Judge Wilson found that the exception is preempted
by federal law unless the FDA finds that such information was withheld. Judge Wilson is
currently presiding over approximately 1,000 Vioxx suits in Texas in which a principal
allegation is failure to warn. Judge Wilson certified the decision for an expedited appeal to
the Texas Court of Civil Appeals. Plaintiffs appealed the decision. On October 11, 2007, Merck
filed a
motion to abate the hearing of the appeal until after the U.S. Supreme Courts decision in
Warner Lambert v. Kent, which is to be decided in 2008. On October 25, 2007, the Texas Court of
Appeals denied Mercks motion to abate. On March 20, 2008, plaintiffs moved to dismiss their
appeal, seeking instead to vacate the trial courts decision. Merck filed an opposition to
plaintiffs motion.
In April 2006, in a trial involving two plaintiffs, Thomas Cona and John McDarby, in Superior
Court of New Jersey, Law Division, Atlantic County, the jury returned a split verdict. The jury
determined that Vioxx did not substantially contribute to the heart attack of Mr. Cona, but did
substantially contribute to the heart attack of Mr. McDarby. The jury also concluded that, in
each case, Merck violated New Jerseys consumer fraud statute, which allows plaintiffs to
receive their expenses for purchasing the drug, trebled, as well as reasonable attorneys fees.
The jury awarded $4.5 million in compensatory damages to Mr. McDarby and his wife, who also was
a plaintiff in that case, as well as punitive damages of $9 million. On June 8, 2007, Judge
Higbee denied Mercks motion for a new trial. On June 15, 2007, Judge Higbee awarded
approximately $4 million in the aggregate in attorneys fees and costs. The Company has
appealed the judgments in both cases and the Appellate Division held oral argument on both cases
on January 16, 2008.
As previously reported, in September 2006, Merck filed a notice of appeal of the August 2005
jury verdict in favor of the plaintiff in the Texas state court case, Ernst v. Merck. Among
several independent grounds for reversal, the Company will argue that there was insufficient
evidence that Mr. Ernst suffered an injury due to Vioxx and that it was improper to allow
testimony by a previously undisclosed witness midway through the trial. Oral argument in the
Texas Court of Civil Appeals was held on April 29, 2008.
As previously reported, in April 2006, in Garza v. Merck, a jury in state court in Rio Grande
City, Texas returned a verdict in favor of the family of decedent Leonel Garza. The jury
awarded a total of $7 million in compensatory damages to Mr. Garzas widow and three sons. The
jury also purported to award $25 million in punitive damages. Under Texas law, in this case the
punitive damages are capped at $750,000. The Company appealed in March 2007. Oral argument in
the Texas Court of Civil Appeals occurred on March 25, 2008.
Other Lawsuits
As previously disclosed, on July 29, 2005, a New Jersey state trial court certified a nationwide
class of third-party payors (such as unions and health insurance plans) that paid in whole or in
part for the Vioxx used by their plan members or insureds. The named plaintiff in that case
sought recovery of certain Vioxx purchase costs (plus penalties) based on allegations that the
purported class members paid more for Vioxx than they would have had they known of the products
alleged risks. On March 31, 2006, the New Jersey Superior Court, Appellate Division, affirmed
the class certification order. On September 6, 2007, the New Jersey Supreme Court reversed the
certification of a nationwide class action of third-party payors, finding that the suit does not
meet the requirements for a class action. Claims of certain individual third-party payors remain
pending in the New Jersey court, and counsel representing various third-party payors have filed
additional such actions. Judge Higbee lifted the stay on these cases and the parties are
currently discussing discovery issues.
Plaintiffs
counsel in Martin-Kleinman v. Merck, which is a putative consumer class action in New Jersey,
pending before Judge Higbee, have filed a new, putative nationwide consumer class action. The action was
removed to federal court, and the JPML (as defined below) has issued an order transferring the
new case to the MDL.
There are also pending in various U.S. courts putative class actions purportedly brought on
behalf of individual purchasers or users of Vioxx claiming either reimbursement of alleged
economic loss or an entitlement to medical monitoring. All of these cases are at early
procedural stages, and no class has been certified. In New Jersey, the trial court dismissed the
complaint in the case of Sinclair v. Merck, a purported statewide medical monitoring class. The
Appellate Division reversed the dismissal, and the issue is now on appeal to the New Jersey
Supreme Court. That court heard argument on October 22, 2007.
As previously reported, the Company has also been named as a defendant in separate lawsuits
brought by the Attorneys General of seven states, and the City of New York. A Colorado taxpayer
has also filed a derivative suit, on behalf of the State of Colorado, naming the Company. These
actions allege that the Company misrepresented the safety of Vioxx and seek (i) recovery of the
cost of Vioxx purchased or reimbursed by the state and its agencies; (ii) reimbursement of all
sums paid by the state and its agencies for medical services for the treatment of persons
- 14 -
Notes to Consolidated Financial Statements (unaudited) (continued)
injured by Vioxx; (iii) damages under various common law theories; and/or (iv) remedies under
various state statutory theories, including state consumer fraud and/or fair business practices
or Medicaid fraud statutes, including civil penalties. In addition, the Company has been named
in three other lawsuits containing similar allegations filed by governmental entities seeking
the reimbursement of alleged Medicaid expenditures for Vioxx. Those lawsuits are (1) a class
action filed by Santa Clara County, California on behalf of all similarly situated California
counties, and (2) actions filed by Erie County and Chautauqua County, New York. With the
exception of the case filed by the Texas
Attorney General (which remains in Texas state court and is currently scheduled for trial in
September 2009) and the Erie and Chautauqua County cases (which are pending transfer), the rest
of the actions described in this paragraph have been transferred to the federal MDL and have not
experienced significant activity to date.
Shareholder Lawsuits
As previously disclosed, in addition to the Vioxx Product Liability Lawsuits, the Company and
various current and former officers and directors are defendants in various putative class
actions and individual lawsuits under the federal securities laws and state securities laws (the
Vioxx Securities Lawsuits). All of the Vioxx Securities Lawsuits pending in federal court have
been transferred by the Judicial Panel on Multidistrict Litigation (the JPML) to the United
States District Court for the District of New Jersey before District Judge Stanley R. Chesler
for inclusion in a nationwide MDL (the Shareholder MDL). Judge Chesler has consolidated the
Vioxx Securities Lawsuits for all purposes. The putative class action, which requested damages
on behalf of purchasers of Company stock between May 21, 1999 and October 29, 2004, alleged that
the defendants made false and misleading statements regarding Vioxx in violation of Sections
10(b) and 20(a) of the Securities Exchange Act of 1934, and sought unspecified compensatory
damages and the costs of suit, including attorneys fees. The complaint also asserted claims
under Section 20A of the Securities and Exchange Act against certain defendants relating to
their sales of Merck stock and under Sections 11, 12 and 15 of the Securities Act of 1933
against certain defendants based on statements in a registration statement and certain
prospectuses filed in connection with the Merck Stock Investment Plan, a dividend reinvestment
plan. On April 12, 2007, Judge Chesler granted defendants motion to dismiss the complaint with
prejudice. Plaintiffs have appealed Judge Cheslers decision to the United States Court of
Appeals for the Third Circuit. Oral argument before the Court of Appeals is scheduled for June
24, 2008.
In October 2005, a Dutch pension fund filed a complaint in the District of New Jersey alleging
violations of federal securities laws as well as violations of state law against the Company and
certain officers. Pursuant to the Case Management Order governing the Shareholder MDL, the case,
which is based on the same allegations as the Vioxx Securities Lawsuits, was consolidated with
the Vioxx Securities Lawsuits. Defendants motion to dismiss the pension funds complaint was
filed on August 3, 2007. In September 2007, the Dutch pension fund filed an amended complaint
rather than responding to defendants motion to dismiss. In addition in 2007, six new complaints
were filed in the District of New Jersey on behalf of various foreign institutional investors
also alleging violations of federal securities laws as well as violations of state law against
the Company and certain officers. Defendants are not required to respond to these complaints
until after the Third Circuit issues a decision on the securities lawsuit currently on appeal.
As previously disclosed, on August 15, 2005, a complaint was filed in Oregon state court by the
State of Oregon through the Oregon state treasurer on behalf of the Oregon Public Employee
Retirement Fund against the Company and certain current and former officers and directors under
Oregon securities law. The Company has filed a motion for summary judgment which is pending. A
trial date has been set for October 2008.
As previously disclosed, various shareholder derivative actions filed in federal court were
transferred to the Shareholder MDL and consolidated for all purposes by Judge Chesler (the
Vioxx Derivative Lawsuits). On May 5, 2006, Judge Chesler granted defendants motion to
dismiss and denied plaintiffs request for leave to amend their complaint. Plaintiffs appealed,
arguing that Judge Chesler erred in denying plaintiffs leave to amend their complaint with
materials acquired during discovery. On July 18, 2007, the United States Court of Appeals for
the Third Circuit reversed the District Courts decision on the grounds that Judge Chesler
should have allowed plaintiffs to make use of the discovery material to try to establish demand
futility, and remanded the case for the District Courts consideration of whether, even with the
additional materials, plaintiffs request to amend their complaint would still be futile.
Plaintiffs filed their brief in support of their request for leave to amend their complaint in
November 2007. That motion is pending.
In addition, as previously disclosed, various putative class actions filed in federal court
under the Employee Retirement Income Security Act (ERISA) against the Company and certain
current and former officers and directors (the Vioxx ERISA Lawsuits and, together with the
Vioxx Securities Lawsuits and the Vioxx Derivative Lawsuits, the Vioxx Shareholder Lawsuits)
have been transferred to the Shareholder MDL and consolidated for all purposes. The consolidated
complaint asserts claims on behalf of certain of the Companys current and former employees who
are
- 15 -
Notes to Consolidated Financial Statements (unaudited) (continued)
participants in certain of the Companys retirement plans for breach of fiduciary duty. The
lawsuits make similar allegations to the allegations contained in the Vioxx Securities Lawsuits.
On July 11, 2006, Judge Chesler granted in part and denied in part defendants motion to dismiss
the ERISA complaint. In October 2007, plaintiffs moved for certification of a class of
individuals who were participants in and beneficiaries of the Companys retirement savings plans
at any time between October 1, 1998 and September 30, 2004 and whose plan accounts included
investments in the Merck Common Stock Fund and/or Merck common stock. That motion is pending.
On April 16, 2008, Plaintiffs filed a Motion for Leave to Supplement the Amended Complaint to
add allegations relating to Vytorin and seeking to
add additional defendants, including Richard T. Clark and additional members of the Board of
Directors. That motion is also pending.
As previously disclosed, on October 29, 2004, two individual shareholders made a demand on the
Companys Board to take legal action against Mr. Raymond Gilmartin, former Chairman, President
and Chief Executive Officer and other individuals for allegedly causing damage to the Company
with respect to the allegedly improper marketing of Vioxx. In December 2004, the Special
Committee of the Board of Directors retained the Honorable John S. Martin, Jr. of Debevoise &
Plimpton LLP to conduct an independent investigation of, among other things, the allegations set
forth in the demand. Judge Martins report was made public in September 2006. Based on the
Special Committees recommendation made after careful consideration of the Martin report and the
impact that derivative litigation would have on the Company, the Board rejected the demand. On
October 11, 2007, the shareholders filed a lawsuit in state court in Atlantic County, NJ against
current and former executives and directors of the Company alleging that the Boards rejection
of their demand was unreasonable and improper, and that the defendants breached various duties
to the Company in allowing Vioxx to be marketed.
International Lawsuits
As previously disclosed, in addition to the lawsuits discussed above, the Company has been named
as a defendant in litigation relating to Vioxx in various countries (collectively, the Vioxx
Foreign Lawsuits) in Europe, as well as Canada, Brazil, Argentina, Australia, Turkey, and
Israel.
Additional Lawsuits
Based on media reports and other sources, the Company anticipates that additional Vioxx Product
Liability Lawsuits, Vioxx Shareholder Lawsuits and Vioxx Foreign Lawsuits (collectively, the
Vioxx Lawsuits) will be filed against it and/or certain of its current and former officers and
directors in the future.
Insurance
As previously disclosed, the Company has product liability insurance for claims brought in the
Vioxx Product Liability Lawsuits with stated upper limits of approximately $630 million after
deductibles and co-insurance. This insurance provides coverage for legal defense costs and
potential damage amounts in connection with the Vioxx Product Liability Lawsuits. The Companys
insurance coverage with respect to the Vioxx Lawsuits will not be adequate to cover its defense
costs and losses.
As previously disclosed, the Companys upper level excess insurers (which provide excess
insurance potentially applicable to all of the Vioxx Lawsuits) had commenced an arbitration
seeking, among other things, to cancel those policies, to void all of their obligations under
those policies and to raise other coverage issues with respect to the Vioxx Lawsuits. As
previously disclosed, in November 2007, the tribunal in the arbitration ruled in the Companys
favor ordering the upper level excess insurers to comply with their obligations under the
policies. The Company recorded a $455 million gain in the fourth quarter of 2007 as a result of
certain other settlements and the tribunals decision. In addition, prior to recording the gain
in the fourth quarter of 2007, as a result of settlements with, and payments made by, certain of
its insurers, the Company had previously received insurance proceeds of approximately $145
million. In the first quarter of 2008, the Company resolved substantially all of its claims
against lower level excess insurers for reimbursement for amounts paid in connection with Vioxx
Product Liability Lawsuits. As a result of settlements that have been made, the Company will
not recover the full amount of the limits discussed in the first paragraph of this section. The
Company has no additional insurance for the Vioxx Product Liability Lawsuits.
The Company has Directors and Officers insurance coverage applicable to the Vioxx Securities
Lawsuits and Vioxx Derivative Lawsuits with stated upper limits of approximately $190 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 arbitration referenced above,
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.
- 16 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Investigations
As previously disclosed, in November 2004, the Company was advised by the staff of the SEC that
it was commencing an informal inquiry concerning Vioxx. On January 28, 2005, the Company
announced that it received notice that the SEC issued a formal notice of investigation. Also,
the Company has received subpoenas from the U.S. Department of Justice (the DOJ) requesting
information related to the Companys research, marketing and selling activities with respect to
Vioxx in a federal health care investigation under criminal statutes. In addition, as previously
disclosed, investigations are being conducted by local authorities in certain cities in Europe
in order to determine whether any criminal charges should be brought concerning Vioxx. The
Company is cooperating with these
governmental entities in their respective investigations (the Vioxx Investigations). The
Company cannot predict the outcome of these inquiries; however, they could result in potential
civil and/or criminal dispositions.
As previously disclosed, the Company has received a number of Civil Investigative Demands
(CID) from a group of Attorneys General from 31 states and the District of Columbia who are
investigating whether the Company violated state consumer protection laws when marketing Vioxx.
The Company is cooperating with the Attorneys General in responding to the CIDs. As previously
disclosed, in the first quarter of 2008 the Company recorded a $55 million charge in connection
with the anticipated resolution of this investigation. The resolution of this matter is still
subject to execution of definitive agreements.
In addition, the Company received a subpoena in September 2006 from the State of California
Attorney General seeking documents and information related to the placement of Vioxx on
Californias Medi-Cal formulary. The Company is cooperating with the Attorney General in
responding to the subpoena.
Reserves
As discussed above, on November 9, 2007, Merck entered into the Settlement Agreement with the
law firms that comprise the executive committee of the PSC of the federal Vioxx MDL as well as
representatives of plaintiffs counsel in the Texas, New Jersey and California state coordinated
proceedings to resolve state and federal MI and IS claims filed as of that date in the United
States. The Settlement Agreement, which also applies to tolled claims, was signed by the parties
after several meetings with three of the four judges overseeing the coordination of more than 95
percent of the U.S. Vioxx Product Liability
Lawsuits. The Settlement Agreement applies only to
U.S. legal residents and those who allege that their MI or IS occurred in the United States. As
a result of entering into the Settlement Agreement, the Company recorded a pretax charge of
$4.85 billion in 2007 which represents the fixed aggregate amount to be paid to plaintiffs qualifying
for payment under the Settlement Program.
The Company currently anticipates that certain Vioxx Product Liability Lawsuits will be tried in
2008. A trial in the Oregon securities case is scheduled for 2008, but the Company cannot
predict whether this trial will proceed on schedule or the timing of any of the other Vioxx
Shareholder Lawsuit trials. The Company believes that it has meritorious defenses to 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. The Company has not
established any reserves for any potential liability relating to the Vioxx Lawsuits not included
in the Settlement Program or the Vioxx Investigations (other than as set forth above), including
for those cases in which verdicts or judgments have been entered against the Company, and are
now in post-verdict proceedings or on appeal. In each of those cases the Company believes it has
strong points to raise on appeal and therefore that unfavorable outcomes in such cases are not
probable. Unfavorable outcomes in the Vioxx Litigation (as
defined below) could have a material adverse effect on
the Companys financial position, liquidity and results of operations.
Legal defense costs expected to be incurred in connection with a loss contingency are accrued
when probable and reasonably estimable. As of December 31, 2007, the Company had a reserve of
$5.372 billion which represented the aggregate amount to be paid under the Settlement Agreement
and its future legal defense costs related to (i) the Vioxx
Product Liability Lawsuits, (ii) the Vioxx Shareholder Lawsuits,
(iii) the Vioxx Foreign Lawsuits,
and (iv) the Vioxx Investigations (collectively, the
Vioxx Litigation). During the first quarter of
2008, the Company spent approximately $79 million in the aggregate in legal defense costs
related to the Vioxx Litigation. Also in the first quarter of 2008, as discussed above, the
Company recorded a pretax charge of $55 million in connection with the anticipated resolution of
the previously-disclosed investigation by a group of Attorneys General from 31 states and the
District of Columbia with respect to the Companys marketing of Vioxx. Thus, as of March 31,
2008, the Company had a reserve of $5.348 billion related to the Vioxx Litigation.
Some of the significant factors considered in the review of the 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
- 17 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Vioxx Litigation, including the Settlement Agreement
and the expectation that the Settlement Agreement will be consummated, but 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 Product Liability
Lawsuits. Events such as scheduled trials, that are expected to occur throughout 2008 and 2009,
and the inherent inability to predict the ultimate outcomes of such trials and the disposition
of Vioxx Product Liability Lawsuits not participating in or not eligible for the Settlement
Program, limit the Companys ability to reasonably estimate its legal costs beyond 2009.
While the Company does not anticipate that it will need to increase the reserve every quarter,
it will continue to monitor its legal defense costs and review the adequacy of the associated
reserves and may determine to increase its
reserves for legal defense costs 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
As previously disclosed, the Company is a defendant in product liability lawsuits in the United
States involving Fosamax (the Fosamax Litigation). As of March 31, 2008, approximately 465
cases, which include approximately 940 plaintiff groups had been filed and were pending against
Merck in either federal or state court, including 3 cases which seek class action certification,
as well as damages and medical monitoring. In these actions, plaintiffs allege, among other
things, that they have suffered osteonecrosis of the jaw, generally subsequent to invasive
dental procedures such as tooth extraction or dental implants, and/or delayed healing, in
association with the use of Fosamax. On August 16, 2006, the JPML ordered that the 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 United States
District Court for the Southern District of New York. As a result of the JPML order,
approximately 410 of the cases are before Judge Keenan. Judge Keenan has issued a Case
Management Order setting forth a schedule governing the proceedings which focuses primarily upon
resolving the class action certification motions in 2007 and completing fact discovery in an
initial group of 25 cases by August 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. On January 28, 2008, Judge Keenan issued a further
order dismissing with prejudice all class claims asserted in the first four class action
lawsuits filed against Merck that sought personal injury damages and/or medical monitoring
relief on a class wide basis. Discovery is ongoing in both the Fosamax MDL litigation as well as
in various state court cases. The Company intends to defend against these lawsuits.
As of December 31, 2007, the Company had a remaining reserve of approximately $27 million solely
for its future legal defense costs for the Fosamax Litigation. During the first quarter of
2008, the Company spent approximately $7 million and added $40 million to its reserve.
Consequently, as of March 31, 2008, the Company had a reserve of approximately $60 million.
Some of the significant factors considered in the establishment of the reserve for the Fosamax
Litigation legal defense costs and its adjustment were as follows: the actual costs incurred by
the Company thus far; the development of the Companys legal defense strategy and structure in
light of the creation of the Fosamax MDL; the number of cases being brought against the Company;
and the anticipated timing, progression, and related costs of pre-trial activities in the
Fosamax Litigation. The Company will continue to monitor its legal defense costs and review the
adequacy of the associated reserves. Due to the uncertain nature of litigation, the Company is
unable to estimate its costs beyond 2009. The Company has not established any reserves for any
potential liability relating to the Fosamax Litigation. Unfavorable outcomes in the Fosamax
Litigation could have a material adverse effect on the Companys financial position, liquidity
and results of operations.
Commercial/Securities Litigation
As
previously disclosed, since December 2007, the Company and its joint-venture partner, Schering-Plough, have received
several letters addressed to both companies from the House Committee on Energy and Commerce, its
Subcommittee on Oversight and Investigations, and the Ranking Minority Member of the Senate Finance
Committee, collectively seeking a combination of witness interviews, documents and information
on a variety of issues related to the ENHANCE clinical trial, the sale and promotion of Vytorin,
as well as sales of stock by corporate officers. On January 25, 2008, the companies and the MSP
Partnership each received two subpoenas from the New York State Attorney Generals Office
seeking similar information and documents. Merck and Schering-Plough have also each received a
letter from the Office of the Connecticut Attorney General dated February 1, 2008 requesting
documents related to the marketing and sale of Vytorin and Zetia and the timing of disclosures
of the results of ENHANCE. Merck and Schering-Plough also received subpoenas dated
April 4, 2008, from the Office of the New Jersey Attorney General seeking documents related to
the ENHANCE trial and the sale and marketing of Vytorin. The Company is cooperating with these
investigations and working with Schering-Plough to respond to the inquiries. In addition, since
mid-January 2008, the Company has become aware of or been served
with approximately 120 civil
class action lawsuits alleging
- 18 -
Notes to Consolidated Financial Statements (unaudited) (continued)
common law and state consumer fraud claims in connection with the
MSP Partnerships sale and promotion of Vytorin and Zetia. Certain of those lawsuits allege
personal injuries and/or seek medical monitoring.
Also, as previously
disclosed, on April 3, 2008, a Merck shareholder
filed a putative class action lawsuit in federal court in the Eastern District of Pennsylvania
alleging that Merck and its Chairman, President and Chief Executive
Officer, Richard T. Clark,
violated the federal securities laws. Specifically, the complaint alleges that Merck delayed
releasing unfavorable results of a clinical study regarding the efficacy of Vytorin and that
Merck made false and misleading statements about expected earnings, knowing that once the
results of the Vytorin study were released, sales of Vytorin would decline and Mercks earnings
would suffer. On April 22, 2008, a member of a Merck ERISA plan filed
a putative class action lawsuit against the Company and certain of
its officers and directors alleging they breached their fiduciary
duties under ERISA. Plaintiff alleges that the ERISA plans
investment in Company stock was imprudent because the Companys
earnings are dependent on the commercial success of its cholesterol
drug Vytorin and that defendants knew or should have known
that the results of a scientific study would cause the medical
community to turn to less expensive drugs for cholesterol management.
The Company intends to defend the lawsuits referred to in this
section vigorously. Unfavorable outcomes resulting from the government
investigations or the civil litigation could have a material adverse effect on the Companys financial position,
liquidity and results of operations.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file ANDAs with the FDA
seeking to market generic forms of the Companys products prior to the expiration of relevant
patents owned by the Company. Generic pharmaceutical manufacturers have submitted ANDAs to the FDA
seeking to market in the United States a generic form of Fosamax, Propecia, Prilosec, Nexium,
Singulair, Trusopt, Cosopt and Primaxin prior to the expiration of the Companys (and AstraZenecas
in the case of Prilosec and Nexium) patents concerning these products. In addition, an ANDA has
been submitted to the FDA seeking to market in the United States a generic form of Zetia prior to
the expiration of Schering-Ploughs patent concerning that product. The generic companies ANDAs
generally include allegations of non-infringement, invalidity and unenforceability of the patents.
Generic manufacturers have received FDA approval to market a generic form of Prilosec. The Company
has filed patent infringement suits in federal court against companies filing ANDAs for generic
alendronate (Fosamax), finasteride (Propecia), dorzolamide (Trusopt), montelukast (Singulair),
dorzolamide/timolol (Cosopt), imipenem/cilastatin (Primaxin) and AstraZeneca and the Company have
filed patent infringement suits in federal court against companies filing ANDAs for generic
omeprazole (Prilosec) and esomeprazole (Nexium). Also, the Company and Schering-Plough have filed a
patent infringement suit in federal court against companies filing ANDAs for generic ezetimibe
(Zetia). Similar patent challenges exist in certain foreign jurisdictions. 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 dates 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.
The Company and AstraZeneca received notice in October 2005 that Ranbaxy Laboratories Ltd.
(Ranbaxy) had filed an ANDA for esomeprazole magnesium. The ANDA contains Paragraph IV challenges
to patents on Nexium. On November 21, 2005, the Company and AstraZeneca sued Ranbaxy in the United
States District Court in New Jersey. Accordingly, FDA approval of
Ranbaxys ANDA was stayed for
30 months until April 2008 or until an adverse court decision, if any, whichever may occur earlier.
As previously disclosed, AstraZeneca, Merck and Ranbaxy have entered into a settlement agreement
which provides that Ranbaxy will not bring its generic esomprazole product to market in the United
States until May 27, 2014.
The Company and AstraZeneca received notice in January 2006 that IVAX Pharmaceuticals, Inc.,
subsequently acquired by Teva Pharmaceuticals (Teva), had filed an ANDA for esomeprazole
magnesium. The ANDA contains Paragraph IV challenges to patents on Nexium. On March 8, 2006, the
Company and AstraZeneca sued Teva in the United States District Court in New Jersey. Accordingly,
FDA approval of Tevas ANDA is stayed for 30 months until September 2008 or until an adverse court
decision, if any, whichever may occur earlier. In January 2008, the Company and AstraZeneca sued
Dr. Reddys in the District Court in New Jersey based on Dr. Reddys filing of an ANDA for
esomeprazole magnesium. Accordingly, FDA approval of Dr. Reddys ANDA is stayed for 30 months until
July 2010 or until an adverse court decision, if any, whichever may occur earlier.
Other Litigation
As
previously disclosed, in February 2008, an individual shareholder delivered a letter to the Companys Board of
Directors demanding that the Board take legal action against the responsible individuals to
recover the amounts paid by the Company to resolve the governmental
investigations, which were settled in February 2008. As part of the
settlement, the Company agreed to pay approximately $649 million plus
interest and reasonable fees and expenses to the government.
As previously disclosed, on August 20, 2004, the United States District Court for the District
of New Jersey granted a motion by the Company, Medco Health Solutions, Inc. (Medco Health) and
certain officers and directors to dismiss a shareholder derivative action involving claims
related to the Companys revenue recognition practice for retail co-payments paid by individuals
to whom Medco Health provides pharmaceutical benefits as well as other allegations. The
complaint was dismissed with prejudice. Plaintiffs appealed the decision. On December 15, 2005,
the U.S. Court of Appeals for the Third Circuit upheld most of the District Courts decision
dismissing the suit, and sent the issue of whether the Companys Board of Directors properly
refused the shareholder demand relating to the Companys treatment of retail co-payments back to
the District Court for reconsideration under a different legal standard. Plaintiffs moved to
remand their action to state court on August 18, 2006, and the District Court granted that
motion on February 1, 2007. The shareholder derivative suit was pending before the Superior
Court of New Jersey, Chancery Division, Hunterdon County. All of the remaining issues were
dismissed with prejudice in favor of Medco Health, Merck and the individual defendants on July
31, 2007.
As previously disclosed, prior to the spin-off of Medco Health, the Company and Medco Health
agreed to settle, on a class action basis, a series of lawsuits asserting violations of ERISA
(the Gruer Cases). The Company, Medco Health and certain plaintiffs counsel filed the
settlement agreement with the federal District Court in New York, where cases commenced by a
number of plaintiffs, including participants in a number of pharmaceutical benefit plans for
which Medco Health is the pharmacy benefit manager, as well as trustees of such plans, have been
consolidated. Medco Health and the Company agreed to the proposed settlement in order to avoid
the significant cost and distraction of prolonged litigation. The proposed class settlement has
been agreed to by plaintiffs in five of the cases filed against Medco Health and the Company.
Under the proposed settlement, the Company and Medco Health have agreed to pay a total of $42.5
million, and Medco Health has agreed to modify certain business practices or to continue certain
specified business practices for a period of five years. The financial compensation is intended
to benefit members of the settlement class, which includes ERISA plans for which Medco Health
administered a pharmacy benefit at any time since December 17, 1994. The District Court held
hearings to hear objections to the fairness of the proposed settlement and approved the
settlement in 2004, but has not yet determined the number of class member plans that have
properly elected not to participate in the settlement. The settlement becomes final only if and
when all appeals have been resolved. Certain class member plans have indicated that they will
not participate in the settlement. Cases initiated by three such plans and two individuals
remain pending in the Southern District of New York. Plaintiffs in these cases have asserted
claims based on ERISA as well as other federal and state laws that are the same as or similar to
the claims that had been asserted by settling class members in the Gruer Cases. The Company and
Medco Health are named as defendants in these cases.
Three notices of appeal were filed and the appellate court heard oral argument in May 2005. On
December 8, 2005, the appellate court issued a decision vacating the District Courts judgment
and remanding the cases to the District Court to allow the District Court to resolve certain
jurisdictional issues. A hearing was held to address such issues on February 24, 2006. The
District Court issued a ruling on August 10, 2006 resolving such jurisdictional issues in favor
of the settling plaintiffs. The class members and the other party that had previously appealed
the District Courts judgment renewed their appeals. On October 4, 2007, the renewed appeals
were affirmed in part and vacated in part by the federal court of appeals. The appeals court
remanded the class settlement for further proceedings in the District Court. The amended
settlement and proposed notice have been filed and a hearing on the settlement is expected in
the second quarter of 2008.
After the spin-off of Medco Health, Medco Health assumed substantially all of the liability
exposure for the matters discussed in the foregoing two paragraphs. These cases are being
defended by Medco Health.
- 19 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
There are various other legal proceedings, principally product liability and intellectual
property suits involving the Company, which 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 are either adequately covered by insurance or, if not so covered,
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. |
|
8. |
|
Share-Based Compensation |
|
|
|
The Company has share-based compensation plans under which employees, non-employee directors and
employees of certain of the Companys equity method investees may be granted options to purchase
shares of Company
common stock at the fair market value at the time of grant. In addition to stock options, the
Company grants performance share units (PSUs) and restricted stock units (RSUs) 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) |
|
2008 |
|
2007 |
|
Pretax share-based compensation expense |
|
$ |
91.0 |
|
|
$ |
97.0 |
|
Income tax benefits |
|
|
(28.7 |
) |
|
|
(30.4 |
) |
|
Total share-based compensation expense, net of tax |
|
$ |
62.3 |
|
|
$ |
66.6 |
|
|
During the first three months of 2008 and 2007, the Company granted 32.2 million options and
31.1 million options, respectively, related to its annual grant and other grants. The weighted
average fair value of options granted for the first three months of 2008 and 2007 was $10.20 and
$9.04 per option, respectively, and was determined using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2008 |
|
2007 |
|
Expected dividend yield |
|
|
3.4 |
% |
|
|
3.4 |
% |
Risk-free interest rate |
|
|
2.7 |
% |
|
|
4.4 |
% |
Expected volatility |
|
|
30.8 |
% |
|
|
24.3 |
% |
Expected life (years) |
|
|
6.1 |
|
|
|
5.7 |
|
|
|
|
At March 31, 2008, there was $730.4 million of total pretax unrecognized compensation expense
related to nonvested stock options, RSU and PSU awards which will be recognized over a weighted
average period of 2.4 years. For segment reporting, share-based compensation costs are
unallocated expenses. |
|
9. |
|
Pension and Other Postretirement Benefit Plans |
|
|
|
The Company has defined benefit pension plans covering eligible employees in the United States
and in certain of its international subsidiaries. The net cost of such plans consisted of the
following components: |
- 20 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Service cost |
|
$ |
92.7 |
|
|
$ |
92.1 |
|
Interest cost |
|
|
107.3 |
|
|
|
92.0 |
|
Expected return on plan assets |
|
|
(148.0 |
) |
|
|
(121.4 |
) |
Net amortization |
|
|
22.6 |
|
|
|
34.2 |
|
Termination benefits |
|
|
5.5 |
|
|
|
7.1 |
|
|
|
|
$ |
80.1 |
|
|
$ |
104.0 |
|
|
|
|
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) |
|
2008 |
|
2007 |
|
Service cost |
|
$ |
22.2 |
|
|
$ |
21.1 |
|
Interest cost |
|
|
30.8 |
|
|
|
25.9 |
|
Expected return on plan assets |
|
|
(34.6 |
) |
|
|
(30.3 |
) |
Net amortization |
|
|
(3.8 |
) |
|
|
(2.5 |
) |
Termination benefits |
|
|
1.2 |
|
|
|
0.9 |
|
Curtailments |
|
|
(0.6 |
) |
|
|
|
|
|
|
|
$ |
15.2 |
|
|
$ |
15.1 |
|
|
|
|
In connection with restructuring actions (see Note 2), the Company recorded termination charges
for the three months ended March 31, 2008 and 2007 on its pension and other postretirement
benefit plans related to expanded eligibility for certain employees exiting the Company. Also,
in connection with these restructuring actions, the Company recorded curtailment gains on its
other postretirement benefit plans for the three months ended March 31, 2008. |
10. |
|
Other (Income) Expense, Net |
|
|
|
Other (income) expense, net, consisted of: |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Interest income |
|
$ |
(169.5 |
) |
|
$ |
(181.7 |
) |
Interest expense |
|
|
72.6 |
|
|
|
102.4 |
|
Exchange losses (gains) |
|
|
12.6 |
|
|
|
(19.6 |
) |
Minority interests |
|
|
31.9 |
|
|
|
30.6 |
|
Other, net |
|
|
(2,124.9 |
) |
|
|
(187.7 |
) |
|
|
|
$ |
(2,177.3 |
) |
|
$ |
(256.0 |
) |
|
|
|
Other, net in 2008 primarily reflects an aggregate gain from AZLP of $2.2 billion (see Note 5)
and a gain of $249 million related to the sale of the Companys remaining worldwide rights to
Aggrastat, partially offset by a $300 million expense for a contribution to the Merck Company
Foundation and a $55 million charge related to the anticipated resolution of an investigation
into whether the Company violated consumer protection laws with respect to the sales and
marketing of Vioxx (see Note 7). Other, net in 2007 primarily reflects the favorable impact of
gains on sales of assets and product divestitures. Interest paid for the three months ended
March 31, 2008 and 2007 was $68.9 million and $101.7 million, respectively. |
11. |
|
Taxes on Income |
|
|
|
The effective tax rate of 25.1% for the first quarter of 2008 reflects the unfavorable impact of
the AZLP gain being fully taxable in the United States at a combined federal and state tax rate
of approximately 36.3%, partially offset by the |
- 21 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
favorable impact of approximately 4 percentage
points relating to the first quarter realization of foreign tax credits. In the first quarter
of 2008, the Company decided to repatriate certain prior years foreign earnings which will
result in a utilization of foreign tax credits. These foreign tax credits arose as a result of
tax payments made outside of the United States in prior years that became realizable in the
current period based on a change in the Companys repatriation plans. The effective tax rate of
24.4% for the first quarter of 2007 reflects the impact of costs associated with the global
restructuring program. |
|
|
As previously disclosed, Mercks Canadian tax returns for the years 1998 through 2004 are being
examined by the Canada Revenue Agency (CRA). In October 2006, the CRA issued the Company a
notice of reassessment containing adjustments related to certain intercompany pricing matters,
which result in additional Canadian and provincial tax due of approximately $1.6 billion (U.S.
dollars) plus interest of approximately $910 million (U.S. dollars). In addition, in July 2007,
the CRA proposed additional adjustments for 1999 relating to another intercompany pricing
matter. The adjustments would increase Canadian tax due by approximately $22 million (U.S.
dollars) plus $22 million (U.S. dollars) of interest. It is possible that the CRA will propose
similar adjustments for later years. The Company disagrees with the positions taken by the CRA
and believes they are without merit. The Company intends to contest the assessments through the
CRA appeals process and the courts if necessary. In connection with the appeals process, during
2007, the Company pledged collateral to two financial institutions, one of which provided a
guarantee to the CRA and the other to the Quebec Ministry of Revenue representing a portion of
the tax and interest assessed. The collateral is included in Other Assets in the Consolidated
Balance Sheet and totaled approximately $1.4 billion at March 31, 2008. The Company has
previously established reserves for these matters. While the resolution of these matters may
result in liabilities higher or lower than the reserves, management believes that resolution of
these matters will not have a material effect on the Companys financial position or liquidity.
However, an unfavorable resolution could have a material adverse effect on the Companys results
of operations or cash flows in the quarter in which an adjustment is recorded or tax is due. |
|
|
|
In July 2007, the CRA notified the Company that it is in the process of proposing a penalty of
$160 million (U.S. dollars) in connection with the 2006 notice. The penalty is for failing to
provide information on a timely basis. The Company vigorously disagrees with the penalty and
feels it is inapplicable and that appropriate information was provided on a timely basis. The
Company is pursuing all appropriate remedies to avoid having the penalty assessed and was
notified in early August 2007 that the CRA is holding the imposition of a penalty in abeyance
pending a review of the Companys submissions as to the inapplicability of a penalty. |
12. |
|
Earnings Per Share |
|
|
|
The weighted average common shares used in the computations of basic earnings per common share
and earnings per common share assuming dilution (shares in millions) are as follows: |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2008 |
|
2007 |
|
Average common shares outstanding |
|
|
2,160.3 |
|
|
|
2,166.1 |
|
Common shares issuable(1) |
|
|
14.4 |
|
|
|
13.9 |
|
|
Average common shares outstanding assuming dilution |
|
|
2,174.7 |
|
|
|
2,180.0 |
|
|
|
|
|
|
|
(1) |
|
Issuable primarily under share-based compensation plans. |
|
|
For the three months ended March 31, 2008 and 2007, 202.8 million and 207.0 million,
respectively, of common shares issuable under the Companys share-based compensation plans were
excluded from the computation of earnings per common share assuming dilution because the effect
would have been antidilutive. |
13. |
|
Comprehensive Income |
|
|
|
Comprehensive income was $3,364.3 million and $1,776.0 million for the three months ended March
31, 2008 and 2007, respectively. |
- 22 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
The Companys operations are principally managed on a products basis and are comprised of two
reportable segments: the Pharmaceutical segment and the Vaccines and Infectious Diseases
segment. Segment composition reflects certain managerial changes that were implemented in early
2008. In addition, in the first quarter of 2008, the Company revised the calculation of segment
profits to include a greater allocation of costs to the segments. Segment disclosures for 2007
have been recast on a comparable basis with 2008. |
|
|
The Pharmaceutical segment includes human health pharmaceutical products marketed either
directly or through joint ventures. These products consist of therapeutic and preventive
agents, sold by prescription, for the treatment of human disorders. Merck 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. The Vaccines and Infectious Diseases segment
includes human health vaccine and infectious disease products marketed either directly or
through joint ventures. Vaccine products consist of preventive pediatric, adolescent and adult
vaccines, primarily administered at physician offices. Merck 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.
Infectious disease products consist of therapeutic agents for the treatment of infection sold
primarily to drug wholesalers, retailers, hospitals and government agencies. The Vaccines and
Infectious Diseases segment includes the aggregate majority of the Companys vaccine and infectious
disease product sales, but excludes sales of these products by
non-U.S. subsidiaries, which are
included in the Pharmaceutical segment. |
|
|
Other segments include other non-reportable human and animal health segments. |
|
|
|
Revenues and profits for these segments are as follows: |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Segment revenues: |
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
4,811.4 |
|
|
$ |
4,774.1 |
|
Vaccines and Infectious Diseases segment |
|
|
985.6 |
|
|
|
931.5 |
|
Other segment revenues |
|
|
25.0 |
|
|
|
36.7 |
|
|
|
|
$ |
5,822.0 |
|
|
$ |
5,742.3 |
|
|
|
|
|
|
|
|
|
|
|
Segment profits:(1) |
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
3,119.3 |
|
|
$ |
3,241.5 |
|
Vaccines and Infectious Diseases segment |
|
|
624.6 |
|
|
|
510.5 |
|
Other segment profits |
|
|
145.9 |
|
|
|
154.1 |
|
|
|
|
$ |
3,889.8 |
|
|
$ |
3,906.1 |
|
|
|
|
|
|
(1) |
Includes the majority of Equity income from affiliates. |
- 23 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
|
|
|
Sales (1) of the Companys products were as follows: |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
Singulair |
|
$ |
1,103.8 |
|
|
$ |
1,002.0 |
|
Cozaar/Hyzaar |
|
|
846.9 |
|
|
|
798.0 |
|
Fosamax |
|
|
469.8 |
|
|
|
742.2 |
|
Januvia |
|
|
272.1 |
|
|
|
87.0 |
|
Cosopt/Trusopt |
|
|
201.3 |
|
|
|
186.1 |
|
Zocor |
|
|
179.1 |
|
|
|
258.4 |
|
Maxalt |
|
|
121.6 |
|
|
|
107.4 |
|
Propecia |
|
|
105.0 |
|
|
|
95.3 |
|
Vasotec/Vaseretic |
|
|
95.7 |
|
|
|
121.6 |
|
Arcoxia |
|
|
93.4 |
|
|
|
80.4 |
|
Proscar |
|
|
85.0 |
|
|
|
125.3 |
|
Emend |
|
|
59.6 |
|
|
|
47.6 |
|
Janumet |
|
|
58.4 |
|
|
|
|
|
Other pharmaceutical (2) |
|
|
589.9 |
|
|
|
693.9 |
|
Vaccine and infectious disease product sales
included in the Pharmaceutical segment (3) |
|
|
529.8 |
|
|
|
428.9 |
|
|
Pharmaceutical segment revenues |
|
|
4,811.4 |
|
|
|
4,774.1 |
|
|
Vaccines(4) and Infectious Diseases: |
|
|
|
|
|
|
|
|
Gardasil |
|
|
390.4 |
|
|
|
365.4 |
|
RotaTeq |
|
|
190.1 |
|
|
|
85.0 |
|
Zostavax |
|
|
73.5 |
|
|
|
42.7 |
|
ProQuad/M-M-R II/Varivax |
|
|
225.6 |
|
|
|
246.1 |
|
Hepatitis vaccines |
|
|
33.9 |
|
|
|
71.5 |
|
Other vaccines |
|
|
72.6 |
|
|
|
92.1 |
|
Primaxin |
|
|
202.6 |
|
|
|
197.0 |
|
Cancidas |
|
|
148.9 |
|
|
|
134.1 |
|
Crixivan/Stocrin |
|
|
75.3 |
|
|
|
82.3 |
|
Invanz |
|
|
55.5 |
|
|
|
41.6 |
|
Isentress |
|
|
46.5 |
|
|
|
2.5 |
|
Other infectious disease |
|
|
0.5 |
|
|
|
0.1 |
|
Vaccine and infectious disease product sales
included in the Pharmaceutical segment (3) |
|
|
(529.8 |
) |
|
|
(428.9 |
) |
|
Vaccines and Infectious Diseases segment revenues |
|
|
985.6 |
|
|
|
931.5 |
|
|
Other segment (5) |
|
|
25.0 |
|
|
|
36.7 |
|
|
Total segment revenues |
|
|
5,822.0 |
|
|
|
5,742.3 |
|
|
Other (6) |
|
|
0.1 |
|
|
|
27.1 |
|
|
|
|
$ |
5,822.1 |
|
|
$ |
5,769.4 |
|
|
|
|
|
|
|
(1) |
|
Presented net of discounts and returns. |
|
|
(2) |
|
Other pharmaceutical primarily includes sales of other human pharmaceutical
products and revenue from the Companys relationship with AstraZeneca LP primarily relating
to sales of Nexium, as well as Prilosec. Revenue from AstraZeneca LP was $404.7 million
and $497.6 million for the first quarter of 2008 and 2007, respectively. |
|
|
(3) |
|
Sales of vaccine and infectious disease products by non-U.S. subsidiaries are
included in the Pharmaceutical segment. |
|
|
(4) |
|
These amounts do not reflect sales of vaccines sold in most major European
markets through the Companys joint venture, Sanofi Pasteur MSD, the results of which are
reflected in Equity income from affiliates. These amounts do reflect supply sales to
Sanofi Pasteur MSD. |
|
|
(5) |
|
Includes other non-reportable human and animal health segments. |
|
|
(6) |
|
Other revenues are primarily comprised of miscellaneous corporate revenues, sales
related to divested products or businesses and other supply sales not included in segment
results. |
- 24 -
Notes to Consolidated Financial Statements (unaudited) (continued)
A reconciliation of segment profits to Income Before Taxes is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Segment profits |
|
$ |
3,889.8 |
|
|
$ |
3,906.1 |
|
Other profits |
|
|
(12.1 |
) |
|
|
0.2 |
|
Adjustments |
|
|
98.8 |
|
|
|
82.9 |
|
Unallocated: |
|
|
|
|
|
|
|
|
Interest income |
|
|
169.5 |
|
|
|
181.7 |
|
Interest expense |
|
|
(72.6 |
) |
|
|
(102.4 |
) |
Equity income from affiliates |
|
|
15.1 |
|
|
|
47.7 |
|
Depreciation and amortization |
|
|
(363.1 |
) |
|
|
(466.4 |
) |
Research and development |
|
|
(1,078.3 |
) |
|
|
(1,030.0 |
) |
Gain on distribution from AstraZeneca LP |
|
|
2,222.7 |
|
|
|
|
|
Other expenses, net |
|
|
(458.8 |
) |
|
|
(365.4 |
) |
|
|
|
$ |
4,411.0 |
|
|
$ |
2,254.4 |
|
|
|
|
Segment profits are comprised of segment revenues less certain elements of materials and
production costs and operating expenses, including the majority of equity income from affiliates
and components of depreciation and amortization expenses. For internal management reporting
presented to the chief operating decision maker, the Company does not allocate the vast majority
of research and development expenses, general and administrative expenses, depreciation related
to fixed assets utilized by nonmanufacturing divisions, as well as the cost of financing these
activities. Separate divisions maintain responsibility for monitoring and managing these costs
and, therefore, they are not included in segment profits. |
|
|
|
Other profits are primarily comprised of miscellaneous corporate profits as well as operating
profits related to 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, includes expenses
from corporate and manufacturing cost centers and other miscellaneous income (expense), net. |
- 25 -
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
Operating Results
Sales
Worldwide sales were $5.8 billion for the first quarter of 2008, an increase of 1% compared with
the first quarter of 2007, primarily attributable to a 4% favorable effect from foreign exchange,
partially offset by a 2% unfavorable effect from price changes and a nearly 2% unfavorable effect
from volume. Revenue growth over 2007 reflects higher sales of Januvia and sales of Janumet for
the treatment of type 2 diabetes, strong performance of Singulair, a medicine indicated for the
chronic treatment of asthma and the relief of symptoms of allergic rhinitis, and growth of the
Companys vaccines, including RotaTeq, a vaccine to help protect against rotavirus gastroenteritis
in infants and children, Varivax, a vaccine to help prevent chickenpox, Zostavax, a vaccine to help
prevent shingles (herpes zoster), and Gardasil, a vaccine to help prevent cervical cancer,
precancerous or dysplastic lesions, and genital warts caused by human papillomavirus (HPV) types
6, 11, 16 and 18. Sales growth also benefited from increased sales of Cozaar/Hyzaar* for
hypertension and/or heart failure and sales of Isentress for the treatment of HIV infection. Sales
growth was partially offset by lower sales of Fosamax for the treatment and prevention of
osteoporosis. Fosamax and Fosamax Plus D lost market exclusivity in the United States in February
2008 and April 2008, respectively. Also offsetting sales growth were lower revenues from the
Companys relationship with AstraZeneca LP (AZLP) and lower sales of Zocor, the Companys statin
for modifying cholesterol which lost U.S. market exclusivity in 2006.
|
|
|
* |
|
Cozaar and Hyzaar are registered trademarks of E.I. duPont de Nemours & Company, Wilmington,
Delaware. |
- 26 -
Sales of the Companys products were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
Singulair |
|
$ |
1,103.8 |
|
|
$ |
1,002.0 |
|
Cozaar/Hyzaar |
|
|
846.9 |
|
|
|
798.0 |
|
Fosamax |
|
|
469.8 |
|
|
|
742.2 |
|
Januvia |
|
|
272.1 |
|
|
|
87.0 |
|
Cosopt/Trusopt |
|
|
201.3 |
|
|
|
186.1 |
|
Zocor |
|
|
179.1 |
|
|
|
258.4 |
|
Maxalt |
|
|
121.6 |
|
|
|
107.4 |
|
Propecia |
|
|
105.0 |
|
|
|
95.3 |
|
Vasotec/Vaseretic |
|
|
95.7 |
|
|
|
121.6 |
|
Arcoxia |
|
|
93.4 |
|
|
|
80.4 |
|
Proscar |
|
|
85.0 |
|
|
|
125.3 |
|
Emend |
|
|
59.6 |
|
|
|
47.6 |
|
Janumet |
|
|
58.4 |
|
|
|
|
|
Other pharmaceutical (1) |
|
|
589.9 |
|
|
|
693.9 |
|
Vaccine and infectious disease product sales
included in the Pharmaceutical segment (2) |
|
|
529.8 |
|
|
|
428.9 |
|
|
Pharmaceutical segment revenues |
|
|
4,811.4 |
|
|
|
4,774.1 |
|
|
Vaccines(3) and Infectious Diseases: |
|
|
|
|
|
|
|
|
Gardasil |
|
|
390.4 |
|
|
|
365.4 |
|
RotaTeq |
|
|
190.1 |
|
|
|
85.0 |
|
Zostavax |
|
|
73.5 |
|
|
|
42.7 |
|
ProQuad/M-M-R II/Varivax |
|
|
225.6 |
|
|
|
246.1 |
|
Hepatitis vaccines |
|
|
33.9 |
|
|
|
71.5 |
|
Other vaccines |
|
|
72.6 |
|
|
|
92.1 |
|
Primaxin |
|
|
202.6 |
|
|
|
197.0 |
|
Cancidas |
|
|
148.9 |
|
|
|
134.1 |
|
Crixivan/Stocrin |
|
|
75.3 |
|
|
|
82.3 |
|
Invanz |
|
|
55.5 |
|
|
|
41.6 |
|
Isentress |
|
|
46.5 |
|
|
|
2.5 |
|
Other infectious disease |
|
|
0.5 |
|
|
|
0.1 |
|
Vaccine and infectious disease product sales
included in the Pharmaceutical segment (2) |
|
|
(529.8 |
) |
|
|
(428.9 |
) |
|
Vaccines and Infectious Diseases segment revenues |
|
|
985.6 |
|
|
|
931.5 |
|
|
Other segment (4) |
|
|
25.0 |
|
|
|
36.7 |
|
|
Total segment revenues |
|
|
5,822.0 |
|
|
|
5,742.3 |
|
|
Other (5) |
|
|
0.1 |
|
|
|
27.1 |
|
|
|
|
$ |
5,822.1 |
|
|
$ |
5,769.4 |
|
|
|
|
|
(1) |
|
Other pharmaceutical primarily includes sales of other human pharmaceutical products
and revenue from the Companys relationship with AZLP primarily relating to sales of Nexium,
as well as Prilosec. Revenue from AZLP was $404.7 million and $497.6 million for the first
quarter of 2008 and 2007, respectively. |
|
(2) |
|
Sales of vaccine and infectious disease products by non-U.S. subsidiaries are
included in the Pharmaceutical segment. |
|
(3) |
|
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 reflect supply sales to Sanofi Pasteur MSD. |
|
(4) |
|
Includes other non-reportable human and animal health segments. |
|
(5) |
|
Other revenues are primarily comprised of miscellaneous corporate revenues, sales
related to divested products or businesses and other supply sales not included in segment
results. |
Sales by product are presented net of discounts and returns. The provision for discounts includes
indirect customer discounts that occur when a contracted customer purchases directly through an
intermediary wholesale purchaser, known
- 27 -
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 $547.5 million and $518.7 million for the three months ended March 31, 2008 and
2007, respectively. Inventory levels at key wholesalers for each of the Companys major
pharmaceutical products are generally less than one month.
Pharmaceutical Segment Revenues
Sales of the Pharmaceutical segment increased 1% to $4.81 billion in the first quarter of 2008
reflecting growth of Januvia, Singulair, Cozaar/Hyzaar and sales of Janumet, partially offset by
declines in Fosamax, Nexium supply sales and Zocor.
Worldwide sales were strong for Singulair, reaching $1.1 billion for the first quarter of 2008,
representing growth of 10% over the first quarter of 2007 reflecting the continued demand for
asthma and seasonal and perennial allergic rhinitis medications. Singulair continues to be the
number one prescribed product in the U.S. respiratory market.
Global sales of Cozaar and Hyzaar were $846.9 million for the first quarter of 2008, an increase of
6% compared with the first quarter of 2007, driven largely by the positive effect of foreign
exchange. Cozaar and Hyzaar are among the leading members of the growing angiotensin receptor
blocker class of medicines.
Global sales for Fosamax and Fosamax Plus D (marketed as Fosavance throughout the European Union
(EU) and as Fosamac in Japan) were $469.8 million for the first quarter of 2008, representing a
decline of 37% compared with the first quarter of 2007. Since most formulations of these medicines
have lost U.S. marketing exclusivity, the Company is experiencing a significant decline in sales in
the United States of Fosamax and Fosamax Plus D and the Company expects such declines to continue.
Global sales of Januvia, the first dipeptidyl peptidase-4 (DPP-4) inhibitor approved in the
United States for use in the treatment of type 2 diabetes, were $272.1 million in the first quarter
of 2008 compared with $87.0 million for the first quarter of 2007. Januvia was approved by the
U.S. Food and Drug Administration (FDA) in October 2006 and by the European Commission (EC) in
March 2007. 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.
Global sales of Janumet, Mercks oral antihyperglycemic agent that combines sitagliptin (Mercks
DPP-4 inhibitor, Januvia) with metformin in a single tablet to target all three key defects of type
2 diabetes, were $58.4 million for the first quarter of 2008. Janumet, launched in the United
States in April 2007, is approved, as an adjunct to diet and exercise, to improve blood sugar
control in adult patients with type 2 diabetes who are not adequately controlled on metformin or
sitagliptin alone, or in patients already being treated with the combination of sitagliptin and
metformin. In February 2008, Merck received FDA approval to market Janumet as an initial treatment
for type-2 diabetes.
In April 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency recommended marketing approval for Janumet in the EU. The CHMP also recommended
marketing approval for Tredaptive (nicotinic acid/ laropiprant, MSD) 1000 mg/20 mg tablets for
patients with dyslipidemia or primary hypercholesterolemia. The CHMP issued its positive opinions
following a review of comprehensive data supporting the efficacy, safety and tolerability profiles
of Tredaptive and Janumet. EU marketing authorization by the EC is expected within 67 days from
the date of the CHMP recommendations. If authorized, the decisions will be applicable to the 27
countries that are members of the EU, plus Norway and Iceland.
Worldwide sales of Zocor, Mercks statin for modifying cholesterol, were $179.1 million in the
first quarter of 2008, representing a decline of 31% over the first quarter of 2007 reflecting the
continuing impact of the loss of U.S. market exclusivity in June 2006.
Other
Pharmaceutical segment products experiencing growth in the first
quarter of 2008 compared with the first quarter of 2007 include
Maxalt to treat migraine pain, Cosopt to treat elevated intraocular pressure in patients with
open-angle glaucoma or ocular hypertension, Arcoxia for the treatment of arthritis and pain, Emend
for prevention of acute and delayed nausea and vomiting associated with moderately and highly
emetogenic cancer chemotherapy, as well as for the treatment of post-operative nausea and vomiting,
and Propecia for male pattern hair loss.
During the first quarter of 2008, Merck divested its remaining ownership of Aggrastat in foreign
markets to Iroko Pharmaceuticals.
- 28 -
During the first quarter of 2008, the Company and AZLP entered into an agreement with Ranbaxy
Laboratories Ltd. (Ranbaxy) to settle patent litigation
with respect to esomeprazole (Nexium)
which provides that Ranbaxy will not bring its generic esomeprazole product to market in the United
States until May 27, 2014.
Vaccines and Infectious Diseases Segment Revenues
Sales of the Vaccines and Infectious Diseases segment increased to $985.6 million in the first
quarter of 2008 compared with $931.5 million in the first quarter of 2007. The increase is
primarily attributable to growth in RotaTeq, Varivax, Zostavax and sales of Isentress, partially
offset by lower sales of ProQuad and hepatitis vaccines.
The following discussion of vaccine and infectious disease product sales includes total vaccine
and infectious disease product sales, the aggregate majority of which are included in the Vaccines
and Infectious Diseases segment and the remainder, representing sales of these products by
non-U.S. subsidiaries, are included in the Pharmaceutical segment. These amounts do not reflect
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 are reflected in Vaccines and Infectious Diseases segment revenues.
Worldwide sales of the Companys cervical cancer vaccine Gardasil, as recorded by Merck, were
$390.4 million for the first quarter of 2008, an increase of 7% compared with the first quarter of
2007. During the first quarter of 2008, the Company initiated a
program with respect to Gardasil that provided sales
incentives in the form of volume discounts for private sector
purchasers in the United States. The program terminated on February
29, 2008. Gardasil, the worlds top-selling HPV vaccine and only HPV vaccine available for use in the
United States, currently is indicated for girls and women nine through 26 years of age for the
prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV
types 6, 11, 16 and 18.
In March 2008, the FDA accepted, and designated for priority review, a
supplemental Biologics License Application (sBLA) for the potential use of Gardasil in women aged
27 through 45. A priority designation is intended for products or indications that address unmet
medical needs. Under the Prescription Drug User Fee Act, the FDAs goal is to review and act on
90% of BLAs designated as priority review within six months of receipt. Additional applications
under FDA review include data on protection against vaginal and vulvar cancer caused by HPV types
16 and 18, data on immune memory and data on cross protection. Clinical studies to evaluate the
safety and efficacy of Gardasil in males 16 to 26 years of age continue and the Company expects to
submit to the FDA an indication for males 9 to 26 years of age in 2008.
RotaTeq, Mercks vaccine to help protect against rotavirus gastroenteritis in infants and children,
achieved worldwide sales as recorded by Merck of $190.1 million for the first quarter of 2008
compared with $85.0 million for the first quarter of 2007. The increase was driven largely by the
continued uptake in the United States and successful launches around the world. In addition, sales
in the first quarter of 2008 benefited from a purchase to support the U.S. Centers for Disease
Control and Prevention stockpile.
As previously disclosed, the Company has been working to resolve an issue related to the bulk
manufacturing process for the Companys varicella zoster virus (VZV)-containing vaccines.
Manufacturing of bulk varicella has resumed; however, product will not be available until the
changes have been fully validated and approved by the applicable regulatory agencies. This
situation does not affect the quality of any of Mercks VZV-containing vaccines currently on the
market, any lots of vaccine in inventory that are ready for release to the market or any vaccines
which will be filled and finished from existing VZV bulk. ProQuad, the Companys combination
vaccine that protects against measles, mumps, rubella and chickenpox, one of the VZV-containing
vaccines, is currently not available for ordering; however, orders have been transitioned, as
appropriate, to M-M-R II and Varivax. Total sales as recorded by Merck for ProQuad were $102.2
million for the first quarter of 2007.
Mercks sales of Varivax, the Companys vaccine for the prevention of chickenpox (varicella), were
$148.7 million for the first quarter of 2008 compared with $103.7 million for the first quarter of
2007. Varivax is currently the only vaccine available in the United States to help protect against
chickenpox due to the unavailability of ProQuad. Mercks
sales of M-M-R II, a vaccine to protect against measles, mumps,
and rubella, were $66.9 million for the first quarter of 2008 compared
with $40.1 million for the first quarter of 2007. Sales of
Varivax and M-M-R II were affected by the
unavailability of ProQuad. Combined sales of ProQuad,
M-M-R II and Varivax decreased in the first quarter of
2008 compared with the first quarter of 2007.
In October 2007, the FDA granted Isentress accelerated approval for use in combination with other
antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients
who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral
agents. Isentress is the first medicine to be approved in a new class of antiretroviral drugs
called integrase inhibitors. Isentress works by inhibiting the insertion of HIV DNA into human DNA
by the integrase enzyme. Inhibiting integrase from performing this essential function limits the
ability of the virus to replicate and infect new cells. Merck is also conducting Phase III
clinical trials of Isentress in the treatment-naïve (previously untreated) HIV population. Sales
for Isentress were $46.5 million in the first quarter of 2008.
- 29 -
Other
Vaccines and Infectious Diseases products experiencing growth in the
first quarter of 2008 compared with the first quarter of 2007
include Zostavax, a vaccine to help prevent shingles (herpes zoster),
Cancidas, an anti-fungal product, and Invanz, for the
treatment of selected moderate to severe infection in adults.
The FDA
conducts regular inspections of the Companys facilities, as
they do with all pharmaceutical companies. FDA officials recently
conducted a detailed Good Manufacturing Practices (GMP)
inspection of licensed biological vaccine products, bulk drug
substances and drug components manufactured at Mercks West
Point, Pennsylvania facility. This type of inspection is conducted on a
routine basis by the FDA and is designed to ensure GMP compliance of
all pharmaceutical companies. After this inspection, on
January 17, 2008, Merck received a copy of an inspection report known
as a Form FDA 483. The report detailed 49 inspectional observations noted during
the course of the 30 day inspection considered by the FDA to be
deviations from GMP compliance. Following receipt of the Form
FDA 483, Merck received a Warning Letter from the FDA dated as of
April 28, 2008. The Warning Letter restated much of the information
contained in the FDA Form 483 observations and primarily requested
supplemental information and updates on Mercks response to 12
of those observations. Merck is currently reviewing the Warning
Letter and will respond to the FDA in writing within 15 business days
of receipt of this letter, as required. The Company intends to meet
with the FDA and is committed to working cooperatively with the FDA
regarding this matter. The issuance of the Warning Letter does not
affect any Merck vaccine products currently on the market or in
inventory or the continued supply of
the Companys vaccine products. Failure to correct these
deviations could result in further regulatory action.
Costs, Expenses and Other
In 2005, the Company initiated a series of steps to reduce its cost structure. In November 2005,
the Company announced the initial phase of its global restructuring program designed to reduce the
Companys cost structure, increase efficiency, and enhance competitiveness. As part of this
program, as of March 31, 2008, Merck has sold or closed five manufacturing sites and two
preclinical sites. The Company also has, and may continue to, sell or close certain other
facilities and related assets in connection with the restructuring program. As of March 31 2008,
the Company has eliminated 8,100 positions company-wide and will continue to identify opportunities
for further headcount reductions. The Company, however, continues to hire new employees as the
business requires. Through the end of 2008, when the initial phase of the global restructuring
program is expected to be substantially complete, the cumulative pretax costs are expected to range
from $2.2 billion to $2.4 billion. Approximately 70% of the cumulative pretax costs are non-cash,
relating primarily to accelerated depreciation for those facilities scheduled for closure. The
Company expects to record charges of approximately $100 million to $300 million during 2008. The
Company recorded pretax restructuring costs of $84.6 million ($55.9 million after-tax) and $186.1
million ($123.6 million after-tax) for the three months ended March 31, 2008 and 2007,
respectively. These costs were comprised primarily of accelerated depreciation and separation
costs recorded in Materials and production and Restructuring costs (see Note 2 to the consolidated
financial statements). Merck continues to expect that this phase of its global restructuring
program, combined with expected cost savings in marketing and administrative and research and
development expenses, will yield cumulative pretax savings of $4.5 billion to $5.0 billion from
2006 through 2010.
On
May 5, 2008, the Company announced plans to reduce the size of
its U.S. sales force by 1,200 positions. The costs associated
with these sales force reductions are included in the cost estimates
in the preceding paragraph.
Materials and production costs were $1.24 billion for the first quarter of 2008, a decline of 19%
compared with the first quarter of 2007. Included in the first quarter of 2008 and 2007 were costs
associated with restructuring activities, primarily accelerated depreciation and asset impairment
costs of $14.9 million and $118.1 million, respectively. (See Note 2 to the consolidated
financial statements).
Gross margin was 78.7% in the first quarter of 2008 compared with 73.6% in the first quarter of
2007, which reflect 0.3 and 2.0 percentage point unfavorable impacts, respectively, relating to
costs associated with restructuring activities. Gross margin in the first quarter of 2008 as
compared with the first quarter of 2007 was favorably impacted by product mix and lower costs
resulting from manufacturing efficiencies.
Marketing and administrative expenses were $1.85 billion for the first quarter of 2008, an increase
of 3% compared with the first quarter of 2007. Expenses for the first quarter of 2008 include the
impact of reserving an additional $40 million solely for future legal defense costs for Fosamax
litigation.
Research and development expenses totaled $1.08 billion for the first quarter of 2008, an increase
of 5% over the first quarter of 2007, largely reflecting an increase in development spending in
support of the continued advancement of the research pipeline.
In March 2008, Merck and Dynavax Technologies Corporation (Dynavax) announced that the FDA had
placed a clinical hold on the two Investigational New Drug (IND) applications for V270, an
investigational hepatitis B vaccine being jointly developed for use in adults by Dynavax and Merck.
A clinical hold is an order issued by the FDA to the sponsor to delay a proposed clinical trial or
suspend an ongoing clinical trial. The FDA placed the clinical hold on the investigational vaccine
because of a serious adverse event (SAE) that occurred in one subject who received V270 in a
Phase III study being conducted outside the United States. The subject was preliminarily diagnosed
as having Wegeners granulomatosis, an uncommon disease in which the blood vessels are inflamed.
All subjects in this Phase III study have received all doses per the study protocol and all will
continue to be monitored. No additional clinical trials with V270 will be initiated until the
clinical hold has been resolved. Dynavax and Merck, along with additional collaborators, including
clinical investigators and leading experts, are evaluating the medical history of the individual
who experienced the SAE to understand better the timing and onset of
the disease symptoms, including whether it was a pre-existing condition or was related
to vaccine administration. In April 2008, Dynavax and Merck received formal written notification
from the FDA detailing a request for information relating to the clinical hold on the two INDs for
V270. The FDA requested a review of clinical and preclinical safety data for V270 and all
available information about the single case of Wegeners granulomatosis reported in the Phase III
trial. Dynavax and Merck plan to provide a complete response to the FDA query in a timely manner.
The FDA will then determine whether the data provided are satisfactory for the continuation of the
clinical program.
Also, in March 2008, Merck presented Phase III study results of MK-0524A (extended-release (ER)
niacin/laropiprant) at the annual Scientific Session of the American College of Cardiology.
Patients with dyslipidemia treated with MK-0524A
- 30 -
reported significantly less flushing and
significantly fewer discontinuations due to flushing than patients treated with Niaspan (Abbott).
Niacin is a proven lipid-modifying agent; however, a major barrier to its use is the side effect of
flushing. MK-0524A is an investigational lipid-modifying agent in development by Merck that
combines Merck-developed ER niacin with the agent laropiprant, a novel flushing pathway inhibitor.
The primary endpoint of the study was to compare the effect on flushing between the two treatment
groups as measured by the number of days per week with moderate, severe or extreme flushing.
Across the 16-week treatment period, patients on MK-0524A reported significantly less flushing
compared to the Niaspan group, despite a study design in which patients on MK-0524A were on a
higher dose of niacin therapy than patients on Niaspan throughout most of the study. Except for
flushing which occurred more frequently in the Niaspan group, the safety profile of MK-0524A was
similar to that of Niaspan.
Additionally, in March 2008, Merck announced that based on the recommendation of the Steering
Committee for ACHIEVE (An Assessment of Coronary Health Using an Intima-Media Thickness Endpoint
for Vascular Effects), a study of MK-0524A, further patient enrollment in the study has been placed
on hold. The action will allow the Steering Committee to evaluate the current study design in
light of scientific data from recent IMT (intima-media thickness) studies. Ongoing clinical
studies with MK-0524A, including the 20,000 patient outcomes study known as HPS2-THRIVE, continue
unchanged. The Steering Committee expects to meet in the near future to review additional analyses
and options, and advise on a path forward for ACHIEVE. In the meantime, patients currently
enrolled in ACHIEVE will continue to be followed according to the protocol and all study data will
remain blinded. Merck has begun to notify study investigators and regulatory agencies of this
decision. On April 28, 2008, Merck announced that it had received a not-approvable action letter
from the FDA for the Companys New Drug Application for MK-0524A for the treatment of primary
hypercholesterolemia or mixed dyslipidemia. The Company plans to meet with the FDA and to submit
additional information to enable the agency to further evaluate the benefit/risk profile of
MK-0524A. Also, in the FDAs letter, the agency rejected the proposed trade name Cordaptive for
MK-0524A. At the appropriate time, the Company expects to pursue the alternative trade name
Tredaptive for use in the United States.
Also presented in March 2008 at the annual Scientific Session of the American College of
Cardiology were fifty-two week results of a two-year Phase III study of taranabant, Mercks
investigational medicine to treat obesity. The study on taranabant, Mercks investigational
cannabinoid-1 receptor blocker, showed patients experienced statistically significant weight loss
when taking the drug in combination with diet and exercise. In this study, patients taking
taranabant 2mg experienced more than double the amount of weight loss at 52 weeks compared to
patients treated with placebo. Maximum weight loss in this study was achieved by week 36 and was
maintained throughout the next 16 weeks of the study in patients taking taranabant 2mg. Patients
in all treatment groups were placed on a diet and exercise regimen in addition to therapy or
placebo. In addition, more than two times as many patients treated with taranabant 2mg lost 5% of
their baseline body weight compared with patients on placebo at 52 weeks. Moreover, more than three
times as many patients treated with taranabant 2mg lost 10% of their baseline body weight compared
with patients on placebo at 52 weeks. The primary study efficacy endpoints were the change in body
weight from baseline at 52 weeks and the change in the proportion of patients with at least 5% and
10% reduction in body weight at 52 weeks for both taranabant 2mg and 4mg. Based on the
benefit-risk considerations and the lack of a substantial improvement in the efficacy of taranabant
at the 4mg and 6mg doses seen in Mercks clinical program compared to the 2mg dose, the Company has
decided to continue to evaluate taranabant in doses up to and including 2mg in its Phase III
studies. The most commonly reported adverse events in the study were gastrointestinal and occurred
more frequently in patients taking taranabant. The incidences of psychiatric adverse events were
greater at higher doses of taranabant. There were no significant differences in affect (crying,
tearfulness, mood altered, mood swings), anxiety and depression adverse events groups between
taranabant 2mg and placebo, but these adverse events occurred significantly more in the taranabant
4mg and 6mg groups compared to placebo. Irritability occurred more frequently in patients taking
taranabant.
Also presented in March 2008 at the annual Scientific Session of the American College of
Cardiology were the results of a Phase III pilot dose-ranging study of patients hospitalized with
acute heart failure syndrome and renal impairment treated with rolofylline, an investigational
adenosine A1 receptor antagonist in development by Merck. Rolofylline administered with
intravenous (IV) loop diuretics was associated with improved dyspnea (shortness of breath) and
preserved renal function compared to treatment with placebo and IV diuretics. In addition, in a
post-hoc analysis, treatment with rolofylline was associated with a trend towards reduced 60-day
mortality or hospital readmission for cardiovascular or renal causes. Rolofylline increases renal
blood flow and urine production by blocking adenosine-mediated vasoconstriction of the afferent
arterioles of the kidneys and inhibiting salt and water reabsorption by the kidney. In this small
pilot study, the rates of adverse events seen across treatment groups were similar. The
confirmatory Phase III studies with rolofylline 30mg are underway.
Merck continues to remain focused on augmenting its internal efforts by capitalizing on growth
opportunities ranging from targeted acquisitions to research collaborations, licensing pre-clinical
and clinical compounds and technology transactions to drive both near- and long-term growth.
- 31 -
Restructuring costs, primarily representing separation and other related costs associated with the
Companys global restructuring program, were $69.7 million and $65.8 million for the first quarter
of 2008 and 2007, respectively. Amounts for the first quarter of 2008 were reduced by gains on
sales of facilities and related assets of $48 million. (See Note 2 to the consolidated financial
statements.)
Equity income from affiliates, which reflects the performance of the Companys joint ventures and
other equity method affiliates, was $652.1 million and $652.6 million for the first quarter of 2008
and 2007, respectively. These results reflect lower partnership returns from AZLP offset by higher
equity income from the Merck/Schering-Plough partnership and SPMSD. (See Note 5 to the
consolidated financial statements and Selected Joint Venture and Affiliate Information below.)
Other (income) expense, net in the first quarter 2008 primarily reflects an aggregate gain from
AZLP of $2.2 billion (see Note 5) and a gain of $249 million related to the sale of the Companys
remaining worldwide rights to Aggrastat, partially offset by a $300 million expense for a
contribution to the Merck Company Foundation and a $55 million charge related to the anticipated
resolution of a previously disclosed investigation into whether the Company violated state consumer
protection laws with respect to the sales and marketing of Vioxx (see Note 7 to the consolidated
financial statements). Other (income) expense, net in the first quarter of 2007 primarily reflects
the favorable impact of gains on sales of assets and product divestitures.
Segment Profits
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Pharmaceutical segment |
|
$ |
3,119.3 |
|
|
$ |
3,241.5 |
|
Vaccines and Infectious Diseases segment |
|
|
624.6 |
|
|
|
510.5 |
|
Other segment |
|
|
145.9 |
|
|
|
154.1 |
|
Other |
|
|
521.2 |
|
|
|
(1,651.7 |
) |
|
Income before income taxes |
|
$ |
4,411.0 |
|
|
$ |
2,254.4 |
|
|
Segment profits are comprised of segment revenues less certain elements of materials and production
costs and operating expenses, including the majority of equity income from affiliates and
components of depreciation and amortization expenses. For internal management reporting presented
to the chief operating decision maker, the Company does not allocate the vast majority of research
and development expenses, general and administrative expenses, depreciation related to fixed assets
utilized by nonmanufacturing divisions, as well as the cost of financing these activities.
Separate divisions maintain responsibility for monitoring and managing these costs and, therefore,
they are not included in segment profits. Also excluded from the determination of segment profits
are 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 (expense). These unallocated items are reflected in Other in the above
table. Also included in Other are miscellaneous corporate profits, operating profits related to
divested products or businesses, other supply sales and adjustments to eliminate the effect of
double counting certain items of income and expense.
Pharmaceutical segment profits decreased 4% in the first quarter of 2008, driven by a decline in
Fosamax sales and Nexium supply sales.
Vaccines and Infectious Diseases segment profits increased 22% in the first quarter of 2008
compared with the first quarter of 2007. The increase was primarily driven by the solid
performance of vaccines and the successful launch of Isentress. Vaccines and Infectious Diseases
segment profits also reflect the results from SPMSD included in Equity income from affiliates.
The effective tax rate of 25.1% for the first quarter of 2008 reflects the unfavorable impact of
the AZLP gain being fully taxable in the United States at a combined federal and state tax rate of
approximately 36.3%, partially offset by the favorable impact of approximately 4 percentage points
relating to the first quarter realization of foreign tax credits. In the first quarter of 2008,
the Company decided to repatriate certain prior years foreign earnings which will result in a
utilization of foreign tax credits. These foreign tax credits arose as a result of tax payments
made outside of the United States in prior years that became realizable in the current period based
on a change in the Companys repatriation plans. The
- 32 -
effective tax rate of 24.4% for the first
quarter of 2007 reflects the impact of costs associated with the global restructuring program.
Net income was $3.30 billion for the first quarter of 2008 compared with $1.70 billion for the
first quarter of 2007. Earnings per common share assuming dilution (EPS) for the first quarter
of 2008 were $1.52 compared with $0.78 in the first quarter of 2007. The increase in net income
and EPS in the first quarter of 2008 is primarily attributable to the impact of the gain on
distribution from AZLP as discussed above, lower restructuring charges and the positive impact of
the realization of foreign tax credits.
Selected Joint Venture and Affiliate Information
Merck/Schering-Plough Partnership
The Merck/Schering-Plough partnership (the MSP Partnership) reported combined global sales of
Zetia and Vytorin of $1.2 billion for the first quarter of 2008, representing growth of 6% over the
first quarter of 2007, and a sequential decline of 15% compared with the fourth quarter of 2007.
Global sales of Zetia, the cholesterol-absorption inhibitor also marketed as Ezetrol outside the
United States, were $581.7 million in the first quarter of 2008, an increase of 7% compared with
the first quarter of 2007, and a sequential decline of 14% compared with the fourth quarter of
2007. Global sales of Vytorin, marketed outside the United States as Inegy, were $651.2 million in
the first quarter of 2008, an increase of 4% compared with the first quarter of 2007, and a
sequential decline of 16% compared with the fourth quarter of 2007.
As previously disclosed, in January 2008, the Company announced the results of ENHANCE, an imaging
trial in 720 patients with heterozygous familial hypercholesterolemia, a rare genetic condition
that causes very high levels of LDL bad cholesterol and greatly increases the risk for premature
coronary artery disease. As previously reported, despite the fact that ezetimibe/simvastatin 10/80
mg (Vytorin) significantly lowered LDL bad cholesterol more than simvastatin 80 mg alone, there
was no significant difference between treatment with ezetimibe/simvastatin and simvastatin alone on
the pre-specified primary endpoint, a change in the thickness of carotid artery walls over two
years as measured by ultrasound. There also were no significant differences between treatment with
ezetimibe/simvastatin and simvastatin on the four pre-specified key secondary endpoints: percent of
patients manifesting regression in the average carotid artery intima-media thickness (CA IMT);
proportion of patients developing new carotid artery plaques >1.3 mm; changes in the average
maximum CA IMT; and changes in the average CA IMT plus in the average common femoral artery IMT.
In ENHANCE, when compared to simvastatin alone, ezetimibe/simvastatin significantly lowered LDL
bad cholesterol, as well as triglycerides and C-reactive protein (CRP). Ezetimibe/simvastatin is
not indicated for the reduction of CRP. In the ENHANCE study, the overall safety profile of
ezetimibe/simvastatin in the study was generally consistent with the product label. The ENHANCE
study was not designed nor powered to evaluate cardiovascular clinical events. IMPROVE-IT is
underway and is designed to provide cardiovascular outcomes data for ezetimibe/simvastatin in
patients with acute coronary syndrome. No incremental benefit of ezetimibe/simvastatin on
cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been
established. In March 2008, the results of ENHANCE were reported at the annual Scientific Session
of the American College of Cardiology.
As previously disclosed, the Company anticipates that equity income from the MSP partnership will
be lower than it originally forecasted for 2008 by $700 million.
See Note 7 to the consolidated financial statements for information with respect to litigation
involving Merck and Schering-Plough Corporation (the Partners) and the MSP Partnership related to
the sale and promotion of Zetia and Vytorin.
On April 25, 2008, the Partners announced that they had received a not-approvable letter from the
FDA for the proposed fixed combination of loratadine/montelukast. Montelukast sodium, a
leukotriene receptor antagonist, is sold by Merck as Singulair and loratadine, an antihistamine, is
sold by Schering-Plough as Claritin, both of which are indicated for the relief of symptoms of
allergic rhinitis. The Partners are evaluating the FDAs response.
AstraZeneca LP
As previously disclosed, the 1999 AstraZeneca merger triggered a partial redemption in March 2008
of Mercks limited partnership interest in AstraZeneca LP (AZLP). Upon this redemption, Merck
received $4.3 billion from AZLP. This amount was based primarily on a multiple of Mercks average
annual variable returns derived from sales of the former Astra USA, Inc. products for the three
years prior to the redemption (the Limited Partner Share of Agreed Value). Merck recorded a $1.5
billion pretax gain on the partial redemption. As a result of the partial redemption of Mercks
limited partnership interest, the Company will have lower Partnership returns (which are recorded
in Equity income from affiliates) on a prospective basis resulting from a reduction of the priority
return and the variable returns which were based, in part, upon sales of certain former Astra USA,
Inc. products.
- 33 -
Also, as a result of the 1999 AstraZeneca merger, in exchange for Mercks relinquishment of rights
to future Astra products with no existing or pending U.S. patents at the time of the merger, Astra
paid $967.4 million (the Advance Payment). The Advance Payment was deferred as it remained
subject to a true-up calculation that was directly dependent on the fair market value in March 2008
of the Astra product rights retained by the Company. The calculated True-Up Amount of $243.7
million was returned to AZLP in March 2008 and Merck recognized a pretax gain of $723.7 million
related to the residual Advance Payment balance.
In 1998, Astra purchased an option (the Asset Option) to buy Mercks interest in the KBI
products, excluding the gastrointestinal medicines Nexium and Prilosec (the Non-PPI Products),
for a payment of $443.0 million, which was deferred. The Asset Option is exercisable in the first
half of 2010 at an exercise price equal to the net present value as of March 31, 2008 of projected
future pretax revenue to be received by the Company from the Non-PPI Products (the Appraised
Value). Merck also had the right to require Astra to purchase such interest in 2008 at the
Appraised Value. In February 2008, the Company advised AZLP that it would not exercise the Asset
Option, thus the $443.0 million remains deferred.
The sum of the Limited Partner Share of Agreed Value, the Appraised Value and the True-Up
Amount was guaranteed to be a minimum of $4.7 billion. Distribution of the Limited Partner Share
of Agreed Value less payment of the True-Up Amount resulted in cash receipts to Merck of $4.0
billion and an aggregate pretax gain of $2.2 billion which is included in Other (income) expense,
net. AstraZenecas purchase of Mercks interest in the Non-PPI Products is contingent upon the
exercise of the Asset Option by AstraZeneca in 2010 and, therefore, payment of the
Appraised Value may or may not occur. Also, in March 2008, the outstanding loan from Astra in the
amount of $1.38 billion plus interest through the redemption date was settled. As a result of
these transactions, the Company received net proceeds from AZLP of $2.6 billion in the first
quarter of 2008.
Sanofi Pasteur MSD
Total vaccine sales reported by SPMSD increased to $411.4 million in the first quarter of 2008 from
$194.8 million for the first quarter of 2007 driven by higher sales of Gardasil. SPMSD sales of
Gardasil were $239.8 million for the first quarter of 2008 and $30.2 million for the first quarter
of 2007.
The Company records the results from its interest in the Merck/Schering-Plough partnership, AZLP
and SPMSD in Equity income from affiliates.
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Cash and investments |
|
$ |
16,072.8 |
|
|
$ |
15,390.0 |
|
Working capital |
|
$ |
7,250.0 |
|
|
$ |
2,787.2 |
|
Total debt to total liabilities and equity |
|
|
9.3 |
% |
|
|
11.9 |
% |
|
The increase in working capital was primarily attributable to net cash receipts from AZLP as
discussed above in Selected Joint Venture and Affiliate Information.
During the first three months of 2008, cash provided by operating activities of $2.5 billion
reflects $2.1 billion, of the total $4.0 billion received in connection with a partial redemption
of the Companys partnership interest in AZLP discussed above, representing a distribution of the Companys
accumulated earnings on its investment in AZLP since inception. Cash provided by operating
activities in the first quarter of 2008 was also impacted by a $675 million payment made in
connection with the previously disclosed resolution of investigations of civil claims by federal
and state authorities relating to certain past marketing and selling activities. Cash used by
operating activities of $1.3 billion for the same period of 2007 largely reflects the payment made
under a previously disclosed settlement with the Internal Revenue Service. 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. Cash provided by investing activities in the first
quarter of 2008 was $1.9 billion primarily reflecting the balance of the $4.0 billion distribution
from AZLP representing a return of the Companys investment in AZLP. Cash used in investing
activities of $1.3 billion in the first three months of 2007 reflects the $1.1 billion payment made
on January 3, 2007 in connection with the December 2006 acquisition of Sirna Therapeutics, Inc.
Cash used in financing activities was $3.6 billion for the first quarter of 2008 compared with $1.2
billion in the first quarter of 2007 reflecting the $1.4 billion repayment of debt to AZLP in 2008
and higher purchases of treasury stock.
In
March 2008, the Company entered into a $4.1 billion letter
of credit agreement with a financial institution, which provides that
if participation conditions under the U.S. Vioxx Settlement Agreement (see Note 7) are met or
waived, a letter of credit will be executed and the
- 34 -
Company will pledge collateral to the
financial institution of approximately $5.0 billion pursuant to the terms of the agreement. The
letter of credit will satisfy certain conditions stipulated by the Settlement Agreement. The letter of
credit amount and required collateral balances will decline as payments (after the first $750
million) under the Settlement Agreement are made.
During 2008, the Company anticipates that under the U.S. Vioxx Settlement Agreement, if
participation conditions are met or waived, the Company will make payments of up to approximately
$1.6 billion pursuant to the Settlement Agreement.
As previously disclosed, Mercks Canadian tax returns for the years 1998 through 2004 are
being examined by the Canada Revenue Agency (CRA). In October 2006, the CRA issued the Company a
notice of reassessment containing adjustments related to certain intercompany pricing matters,
which result in additional Canadian and provincial tax due of approximately $1.6 billion (U.S.
dollars) plus interest of approximately $910 million (U.S. dollars). In addition, in July 2007,
the CRA proposed additional adjustments for 1999 relating to another intercompany pricing matter.
The adjustments would increase Canadian tax due by approximately $22 million (U.S. dollars) plus
$22 million (U.S. dollars) of interest. It is possible that the CRA will propose similar
adjustments for later years. The Company disagrees with the positions taken by the CRA and
believes they are without merit. The Company intends to contest the assessments through the CRA
appeals process and the courts if necessary. In connection with the appeals process, during 2007,
the Company pledged collateral to two financial institutions, one of which provided a guarantee to
the CRA and the other to the Quebec Ministry of Revenue representing a portion of the tax and
interest assessed. The collateral is included in Other Assets in the Consolidated Balance Sheet
and totaled approximately $1.4 billion at March 31, 2008. The Company has previously established
reserves for these matters. While the resolution of these matters may result in liabilities higher
or lower than the reserves, management believes that resolution of these matters will not have a
material effect on the Companys financial position or liquidity. However, an unfavorable
resolution could have a material adverse effect on the Companys results of operations or cash
flows in the quarter in which an adjustment is recorded or tax is due.
In July 2007, the CRA notified the Company that it is in the process of proposing a penalty of $160
million (U.S. dollars) in connection with the 2006 notice. The penalty is for failing to provide
information on a timely basis. The Company vigorously disagrees with the penalty and feels it is
inapplicable and that appropriate information was provided on a timely basis. The Company is
pursuing all appropriate remedies to avoid having the penalty assessed and was notified in early
August 2007 that the CRA is holding the imposition of a penalty in abeyance pending a review of the
Companys submissions as to the inapplicability of a penalty.
Capital expenditures totaled $341.4 million and $200.7 million for the first three months of 2008
and 2007, respectively. Capital expenditures for full year 2008 are estimated to be $1.6 billion.
Dividends paid to stockholders were $830.8 million and $826.6 million for the first three months of
2008 and 2007, respectively. In February 2008, the Board of Directors declared a quarterly
dividend of $0.38 per share on the Companys common stock for the second quarter of 2008.
The Company purchased $1.4 billion of its common stock (29.1 million shares) for its Treasury
during the first three months of 2008. The Company has approximately $3.7 billion remaining under
the July 2002 treasury stock purchase authorization.
In April 2008, the Company extended the maturity date of its $1.5 billion, 5-year revolving credit
facility from April 2012 to April 2013. The facility provides backup liquidity for the Companys
commercial paper borrowing facility and is to be used for general corporate purposes. The Company
has not drawn funding from this 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 of the Annual Report on
Form 10-K for the year ended December 31, 2007. Certain of these accounting policies are
considered critical as disclosed in the Critical Accounting Policies and Other Matters section of
Managements Discussion and Analysis in the Companys 2007 Annual Report on Form 10-K because of
the potential for a significant impact on the financial statements due to the inherent uncertainty
in such estimates. Other than the adoption of FAS 157, as discussed below (see also Note 3 to the
consolidated financial statements), there have been no significant changes in the Companys
critical accounting policies since December 31, 2007.
- 35 -
Fair Value Measurements
On January 1, 2008, the Company adopted FAS 157, which clarifies the definition of fair value,
establishes a framework for measuring fair value, and expands the disclosures on fair value
measurements. FAS 157 establishes a fair value hierarchy which requires an entity to maximize the
use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
FAS 157 describes three levels of inputs that may be used to measure fair value (see Note 3 to the
consolidated financial statements). The Companys Level 3 assets primarily include mortgage-backed
and asset-backed securities, as well as certain corporate notes and
bonds for which there was a decrease in the observability of market pricing for these
investments. On January 1, 2008, the Company had $1,273.1 million invested in a short-term fixed
income fund (the Fund). Due to market liquidity conditions, cash redemptions from the Fund were
restricted. As a result of this restriction on cash redemptions, the Company did not consider the
Fund to be traded in an active market with observable pricing on January 1, 2008 and these amounts
were categorized as Level 3. On January 7, 2008, the Company elected to be redeemed-in-kind from
the Fund and received its share of the underlying securities of the
Fund. As a result, $1,099.7 million of the
underlying securities were transferred out of Level 3 as it was
determined these securities had observable markets. On March 31, 2008, $161.2
million of the investment securities associated with the redemption-in-kind remained classified in
Level 3 (approximately 1.5% of the Companys investment securities) as the securities contained at
least one significant input which was unobservable (all of which were pledged under certain
collateral arrangements (see Note 11 to the consolidated financial statements)). At March 31,
2008, these securities were valued primarily using broker pricing models that 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
at March 31, 2008.
Recently Issued Accounting Standards
In March 2008, the FASB issued Statement No. 161, Disclosures about Derivative Instruments and
Hedging Activities (FAS 161), which is effective January 1, 2009. FAS 161 requires enhanced
disclosures about derivative instruments and hedging activities to allow for a better understanding
of their effects on an entitys financial position, financial performance, and cash flows. Among
other things, FAS 161 requires disclosure of the fair values of derivative instruments and
associated gains and losses in a tabular format. Since FAS 161 requires only additional disclosures
about the Companys derivatives and hedging activities, the adoption of FAS 161 will not affect the
Companys financial position or results of operations.
In December 2007, the FASB ratified the consensus reached by the EITF on Issue No. 07-1
(EITF 07-1), Accounting for Collaborative Arrangements. EITF 07-1 is effective for the Company
beginning January 1, 2009 and will be applied retrospectively to all prior periods presented for
all collaborative arrangements existing as of the effective date. EITF 07-1 defines collaborative
arrangements and establishes reporting requirements for transactions between participants in a
collaborative arrangement and between participants in the arrangement and third parties. The
Company is assessing the impact of adoption of EITF 07-1 on its financial position and results of
operations.
In December 2007, the FASB issued Statements No. 141R, Business Combinations (FAS 141R), and No.
160, Noncontrolling Interests in Consolidated Financial Statementsan amendment of ARB No. 51 (FAS
160). FAS 141R expands the scope of acquisition accounting to all transactions under which
control of a business is obtained. Among other things, FAS 141R requires that contingent
consideration as well as contingent assets and liabilities be recorded at fair value on the
acquisition date, that acquired in-process research and development be capitalized and recorded as
intangible assets at the acquisition date, and also requires transaction costs and costs to
restructure the acquired company be expensed. FAS 160 requires, among other things, that
noncontrolling interests be recorded as equity in the consolidated financial statements. FAS 141R
and FAS 160 are both effective January 1, 2009. The Company is assessing the impacts of these
standards on its financial position and results of operations.
Legal Proceedings
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. The following discussion is limited to
recent developments concerning legal proceedings and should be read in conjunction with the
consolidated financial statements contained in this report and the Companys Annual Report on Form
10-K for the year ended December 31, 2007.
- 36 -
Vioxx Litigation
Product Liability Lawsuits
As previously disclosed, individual and putative class actions have been filed against the Company
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 New Jersey, California and
Texas, and the counties of Philadelphia, Pennsylvania and Washoe and Clark Counties, Nevada. As of
March 31, 2008, the Company had been served or was aware that it had been named as a defendant in
approximately 14,450 lawsuits, which include approximately 32,925 plaintiff groups, alleging
personal injuries resulting from the use of Vioxx, and in approximately 260 putative class actions
alleging personal injuries and/or economic loss. (All of the actions discussed in this paragraph
are collectively referred to as the Vioxx Product Liability Lawsuits.) Of these lawsuits,
approximately 9,200 lawsuits representing approximately 24,325 plaintiff groups are or are slated
to be in the federal MDL and approximately 3,350 lawsuits representing approximately 3,350
plaintiff groups are included in a coordinated proceeding in New Jersey Superior Court before Judge
Carol E. Higbee.
In addition to the Vioxx Product Liability Lawsuits discussed above, the claims of over 21,000
plaintiffs had been dismissed as of March 31, 2008. Of these, there have been over 2,250 plaintiffs
whose claims were dismissed with prejudice (i.e., they cannot be brought again) either by
plaintiffs themselves or by the courts. Over 18,750 additional plaintiffs have had their claims
dismissed without prejudice (i.e., subject to the applicable statute of limitations, they can be
brought again). Of these, 11,800 plaintiff groups represent plaintiffs who had lawsuits pending in
the New Jersey Superior Court at the time of the Settlement Agreement described below and who have
expressed an intent to enter the program established by the Settlement Agreement; Judge Higbee has
dismissed these cases without prejudice for administrative reasons.
Merck entered into a tolling agreement (the Tolling Agreement) with the MDL Plaintiffs Steering
Committee (PSC) that established a procedure to halt the running of the statute of limitations
(tolling) as to certain categories of claims allegedly arising from the use of Vioxx by non-New
Jersey citizens. The Tolling Agreement applied to individuals who have not filed lawsuits and may
or may not eventually file lawsuits and only to those claimants who seek to toll claims alleging
injuries resulting from a thrombotic cardiovascular event that results in a myocardial infarction
(MI) or ischemic stroke (IS). The Tolling Agreement provided counsel additional time to
evaluate potential claims. The Tolling Agreement required any tolled claims to be filed in federal
court. As of March 31, 2008, approximately 12,760 claimants had entered into Tolling Agreements.
The parties agreed that April 9, 2007 was the deadline for filing Tolling Agreements and no
additional Tolling Agreements are being accepted.
On November 9, 2007, Merck announced that it had entered into an agreement (the Settlement
Agreement) with the law firms that comprise the executive committee of the PSC of the federal
Vioxx MDL as well as representatives of plaintiffs counsel in the Texas, New Jersey and California
state coordinated proceedings to resolve state and federal MI and IS claims filed as of that date
in the United States. The Settlement Agreement, which also applies to tolled claims, was signed by
the parties after several meetings with three of the four judges overseeing the coordination of
more than 95 percent of the U.S. Vioxx
Product Liability Lawsuits. The Settlement Agreement
applies only to U.S. legal residents and those who allege that their MI or IS occurred in the
United States.
The entire Settlement Agreement, including accompanying exhibits, may be found at
www.merck.com. The Company has included this website address only as an inactive textual
reference and does not intend it to be an active link to its website nor does it incorporate by
reference the information contained therein. If certain participation conditions under the
Settlement Agreement are met, which conditions may be waived by Merck, Merck will pay a fixed
aggregate amount of $4.85 billion into two funds for qualifying claims that enter into the
resolution process (the Settlement Program). Individual claimants will be examined by
administrators of the Settlement Program to determine qualification based on objective, documented
facts provided by claimants, including records sufficient for a scientific evaluation of
independent risk factors. The conditions in the Settlement Agreement also require claimants to pass
three gates: an injury gate requiring objective, medical proof of an MI or IS (each as defined in
the Settlement Agreement), a duration gate based on documented receipt of at least 30 Vioxx pills,
and a proximity gate requiring receipt of pills in sufficient number and proximity to the event to
support a presumption of ingestion of Vioxx within 14 days before the claimed injury.
The Settlement Agreement provides that Merck does not admit causation or fault. Mercks payment
obligations under the Settlement Agreement will be triggered only if, among other conditions,
(1) law firms on the federal and state PSCs and firms that have tried cases in the coordinated
proceedings elect to recommend enrollment in the program to 100 percent of their clients who allege
either MI or IS and (2) by June 30, 2008, plaintiffs enroll in the
Settlement
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Program at least 85 percent of each of all currently pending and tolled (i) MI claims,
(ii) IS claims, (iii) eligible MI and IS claims together which involve death, and (iv) eligible MI
and IS claims together which allege more than 12 months of use. The Company has the right to waive
these participation conditions.
Under the Settlement Agreement, Merck will create separate funds in the amount of $4.0 billion for
MI claims and $850 million for IS claims. Once triggered, Mercks total payment for both funds of
$4.85 billion is a fixed amount to be allocated among qualifying claimants based on their
individual evaluation. While at this time the exact number of claimants covered by the Settlement
Agreement is unknown, the total dollar amount is fixed. Payments to individual qualifying claimants
could begin as early as August 2008 and then will be paid over a period of time. Merck retains its
right to terminate this process without any payment to any claimant, and to defend each claim
individually at trial if any of the aforementioned participation conditions in the Settlement
Agreement are not met or waived.
After the Settlement Agreement was announced on November 9, 2007, judges in the Federal MDL,
California, Texas and New Jersey State Coordinated Proceedings entered a series of orders. The
orders: (1) temporarily stayed their respective litigations; (2) required plaintiffs to register
their claims by January 15, 2008; (3) require plaintiffs with cases pending as of November 9, 2007
to preserve and produce records and serve expert reports; and (4) require plaintiffs who file
thereafter to make similar productions on an accelerated schedule. The Clark County, Nevada and
Washoe County, Nevada coordinated proceedings were also generally stayed.
As of March 31, 2008, more than 45,000 of the approximately 47,500 individuals who registered
eligible injuries have submitted some or all of the materials required for enrollment in the
program to resolve state and federal MI and IS claims filed against the Company in the United
States. If all of these eligible submissions are completed in accordance with the Settlement
Agreement, this would represent more than 94 percent of the eligible MI and IS claims previously
registered with the program. In addition, approximately 5,500 other claimants have also sought to
enroll and their eligibility status still has yet to be determined.
Also, as of March 31, BrownGreer, the claims administrator for the Settlement Program (the Claims
Administrator), reports that more than 28,250 eligible MI claimants have initiated enrollment and
more than 16,750 eligible IS claimants have initiated enrollment. Of these, more than 5,500
eligible MI and IS claimants alleging death as an injury have initiated enrollment and more than
27,500 eligible MI and IS claimants alleging more than 12 months of use have initiated enrollment.
Each of these numbers appears to represent at least 94.5 percent of the eligible claims in each
category. These numbers do not include the additional 5,500 enrollees whose eligibility has yet to
be determined.
On April 14, 2008, various private insurance companies and health plans filed suit against
BrownGreer and U.S. Bancorp, escrow agent for the Settlement Program. The private insurance
companies and health plans claim to have paid healthcare costs on behalf of some of the enrolling
claimants and seek to enjoin the Claims Administrator from paying enrolled claimants until their
claims for reimbursement from the enrolled claimants are resolved.
The registration and enrollment materials currently are being evaluated for eligibility, accuracy
and completeness. The Claims Administrator continues to receive new materials from plaintiffs. The
Company is confident that all 85% thresholds under the Settlement Agreement will be met and
exceeded within the time frames in the Settlement Agreement.
Vioxx Product Liability Lawsuits are currently scheduled for trial in 2008. The Company has
provided a list of such trials at its website at www.merck.com which it will periodically
update as appropriate. The Company has included its website address only as an inactive textual
reference and does not intend it to be an active link to its website nor does it incorporate by
reference the information contained therein.
The Company has previously disclosed the outcomes of several Vioxx Product Liability Lawsuits that
were tried prior to January 1, 2008.
The following sets forth certain significant rulings that occurred in or after the first quarter of
2008 with respect to the Vioxx Product Liability Lawsuits.
On April 19, 2007, Judge Randy Wilson, who presides over the Texas Vioxx coordinated proceeding,
dismissed the failure to warn claim of plaintiff Ruby Ledbetter, whose case was scheduled to be
tried on May 14, 2007. Judge Wilson relied on a Texas statute enacted in 2003 that provides that
there can be no failure to warn regarding a prescription medicine if the medicine is distributed
with FDA approved labeling. There is an exception in the statute if required, material, and
relevant information was withheld from the FDA that would have led to a different decision
regarding the approved labeling, but Judge Wilson found that the exception is preempted by federal
law unless the FDA finds that such information was
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withheld. Judge Wilson is currently presiding
over approximately 1,000 Vioxx suits in Texas in which a principal allegation is failure to warn.
Judge Wilson certified the decision for an expedited appeal to the Texas Court of Civil Appeals.
Plaintiffs appealed the decision. On October 11, 2007, Merck filed a motion to abate the hearing
of the appeal until after the U.S. Supreme Courts decision in Warner Lambert v. Kent, which is to
be decided in 2008. On October 25, 2007, the Texas Court of Appeals denied Mercks motion to
abate. On March 20, 2008, plaintiffs moved to dismiss their appeal, seeking instead to vacate the
trial courts decision. Merck filed an opposition to plaintiffs motion.
In April 2006, in a trial involving two plaintiffs, Thomas Cona and John McDarby, in Superior Court
of New Jersey, Law Division, Atlantic County, the jury returned a split verdict. The jury
determined that Vioxx did not substantially contribute to the heart attack of Mr. Cona, but did
substantially contribute to the heart attack of Mr. McDarby. The jury also concluded that, in each
case, Merck violated New Jerseys consumer fraud statute, which allows plaintiffs to receive their
expenses for purchasing the drug, trebled, as well as reasonable attorneys fees. The jury awarded
$4.5 million in compensatory damages to Mr. McDarby and his wife, who also was a plaintiff in that
case, as well as punitive damages of $9 million. On June 8, 2007, Judge Higbee denied Mercks
motion for a new trial. On June 15, 2007, Judge Higbee awarded approximately $4 million in the
aggregate in attorneys fees and costs. The Company has appealed the judgments in both cases and
the Appellate Division held oral argument on both cases on January 16, 2008.
As previously reported, in September 2006, Merck filed a notice of appeal of the August 2005 jury
verdict in favor of the plaintiff in the Texas state court case, Ernst v. Merck. Among several
independent grounds for reversal, the Company will argue that there was insufficient evidence that
Mr. Ernst suffered an injury due to Vioxx and that it was improper to allow testimony by a
previously undisclosed witness midway through the trial. Oral argument in the Texas Court of Civil
Appeals was held on April 29, 2008.
As previously reported, in April 2006, in Garza v. Merck, a jury in state court in Rio Grande City,
Texas returned a verdict in favor of the family of decedent Leonel Garza. The jury awarded a total
of $7 million in compensatory damages to Mr. Garzas widow and three sons. The jury also purported
to award $25 million in punitive damages. Under Texas law, in this case the punitive damages are
capped at $750,000. The Company appealed in March 2007. Oral argument in the Texas Court of Civil
Appeals occurred on March 25, 2008.
Other Lawsuits
As previously disclosed, on July 29, 2005, a New Jersey state trial court certified a nationwide
class of third-party payors (such as unions and health insurance plans) that paid in whole or in
part for the Vioxx used by their plan members or insureds. The named plaintiff in that case sought
recovery of certain Vioxx purchase costs (plus penalties) based on allegations that the purported
class members paid more for Vioxx than they would have had they known of the products alleged
risks. On March 31, 2006, the New Jersey Superior Court, Appellate Division, affirmed the class
certification order. On September 6, 2007, the New Jersey Supreme Court reversed the certification
of a nationwide class action of third-party payors, finding that the suit does not meet the
requirements for a class action. Claims of certain individual third-party payors remain pending in
the New Jersey court, and counsel representing various third-party payors have filed additional
such actions. Judge Higbee lifted the stay on these cases and the parties are currently discussing
discovery issues.
Plaintiffs
counsel in Martin-Kleinman v. Merck, which is a putative consumer class action in New Jersey,
pending before Judge Higbee, have filed a new, putative nationwide consumer class action. The action was
removed to federal court, and the JPML (as defined below) has issued an order transferring the new
case to the MDL.
There are also pending in various U.S. courts putative class actions purportedly brought on behalf
of individual purchasers or users of Vioxx claiming either reimbursement of alleged economic
loss or an entitlement to medical monitoring. All of these cases are at early procedural stages,
and no class has been certified. In New Jersey, the trial court dismissed the complaint in the case
of Sinclair v. Merck, a purported statewide medical monitoring class. The Appellate Division
reversed the dismissal, and the issue is now on appeal to the New Jersey Supreme Court. That court
heard argument on October 22, 2007.
As previously reported, the Company has also been named as a defendant in separate lawsuits brought
by the Attorneys General of seven states, and the City of New York. A Colorado taxpayer has also
filed a derivative suit, on behalf of the State of Colorado, naming the Company. These actions
allege that the Company misrepresented the safety of Vioxx and seek (i) recovery of the cost of
Vioxx purchased or reimbursed by the state and its agencies; (ii) reimbursement of all sums paid by
the state and its agencies for medical services for the treatment of persons injured by Vioxx;
(iii) damages under various common law theories; and/or (iv) remedies under various state statutory
theories, including state consumer fraud and/or fair business practices or Medicaid fraud statutes,
including civil penalties. In addition, the Company has been named in three other lawsuits
containing similar allegations filed by governmental entities seeking the
- 39 -
reimbursement of alleged
Medicaid expenditures for Vioxx. Those lawsuits are (1) a class action filed by Santa Clara County,
California on behalf of all similarly situated California counties, and (2) actions filed by Erie
County and Chautauqua County, New York. With the exception of the case filed by the Texas Attorney
General (which remains in Texas state court and is currently scheduled for trial in September
2009) and the Erie and Chautauqua County cases (which are pending transfer), the rest of the
actions described in this paragraph have been transferred to the federal MDL and have not
experienced significant activity to date.
Shareholder Lawsuits
As previously disclosed, in addition to the Vioxx Product Liability Lawsuits, the Company and
various current and former officers and directors are defendants in various putative class actions
and individual lawsuits under the federal securities laws and state securities laws (the Vioxx
Securities Lawsuits). All of the Vioxx Securities Lawsuits pending in federal court have been
transferred by the Judicial Panel on Multidistrict Litigation (the JPML) to the United States
District Court for the District of New Jersey before District Judge Stanley R. Chesler for
inclusion in a nationwide MDL (the Shareholder MDL). Judge Chesler has consolidated the Vioxx
Securities Lawsuits for all purposes. The putative class action, which requested damages on behalf
of purchasers of Company stock between May 21, 1999 and October 29, 2004, alleged that the
defendants made false and misleading statements regarding Vioxx in violation of Sections 10(b) and
20(a) of the Securities Exchange Act of 1934, and sought unspecified compensatory damages and the
costs of suit, including attorneys fees. The complaint also asserted claims under Section 20A of
the Securities and Exchange Act against certain defendants relating to their sales of Merck stock
and under Sections 11, 12 and 15 of the Securities Act of 1933 against certain defendants based on
statements in a registration statement and certain prospectuses filed in connection with the Merck
Stock Investment Plan, a dividend reinvestment plan. On April 12, 2007, Judge Chesler granted
defendants motion to dismiss the complaint with prejudice. Plaintiffs have appealed Judge
Cheslers decision to the United States Court of Appeals for the Third Circuit. Oral argument
before the Court of Appeals is scheduled for June 24, 2008.
In October 2005, a Dutch pension fund filed a complaint in the District of New Jersey alleging
violations of federal securities laws as well as violations of state law against the Company and
certain officers. Pursuant to the Case Management Order governing the Shareholder MDL, the case,
which is based on the same allegations as the Vioxx Securities Lawsuits, was consolidated with the
Vioxx Securities Lawsuits. Defendants motion to dismiss the pension funds complaint was filed on
August 3, 2007. In September 2007, the Dutch pension fund filed an amended complaint rather than
responding to defendants motion to dismiss. In addition in 2007, six new complaints were filed in
the District of New Jersey on behalf of various foreign institutional investors also alleging
violations of federal securities laws as well as violations of state law against the Company and
certain officers. Defendants are not required to respond to these complaints until after the Third
Circuit issues a decision on the securities lawsuit currently on appeal.
As previously disclosed, on August 15, 2005, a complaint was filed in Oregon state court by the
State of Oregon through the Oregon state treasurer on behalf of the Oregon Public Employee
Retirement Fund against the Company and certain current and former officers and directors under
Oregon securities law. The Company has filed a motion for summary judgment which is pending. A
trial date has been set for October 2008.
As previously disclosed, various shareholder derivative actions filed in federal court were
transferred to the Shareholder MDL and consolidated for all purposes by Judge Chesler (the Vioxx
Derivative Lawsuits). On May 5, 2006, Judge Chesler granted defendants motion to dismiss and
denied plaintiffs request for leave to amend their complaint. Plaintiffs appealed, arguing that
Judge Chesler erred in denying plaintiffs leave to amend their complaint with materials acquired
during discovery. On July 18, 2007, the United States Court of Appeals for the Third Circuit
reversed the District Courts decision on the grounds that Judge Chesler should have allowed
plaintiffs to make use of the discovery material to try to establish demand futility, and remanded
the case for the District Courts consideration of whether, even with the additional materials,
plaintiffs request to amend their complaint would still be futile. Plaintiffs filed their brief in
support of their request for leave to amend their complaint in November 2007. That motion is
pending.
In addition, as previously disclosed, various putative class actions filed in federal court under
the Employee Retirement Income Security Act (ERISA) against the Company and certain current and
former officers and directors (the Vioxx ERISA Lawsuits and, together with the Vioxx Securities
Lawsuits and the Vioxx Derivative Lawsuits, the Vioxx Shareholder Lawsuits) have been transferred
to the Shareholder MDL and consolidated for all purposes. The consolidated complaint asserts claims
on behalf of certain of the Companys current and former employees who are participants in certain
of the Companys retirement plans for breach of fiduciary duty. The lawsuits make similar
allegations to the allegations contained in the Vioxx Securities Lawsuits. On July 11, 2006, Judge
Chesler granted in part and denied in part defendants motion to dismiss the ERISA complaint. In
October 2007, plaintiffs moved for certification of a class of individuals who were participants in
and beneficiaries of the Companys retirement savings plans at any time between October 1, 1998 and
September 30, 2004 and whose plan accounts included investments in the Merck Common Stock Fund
and/or Merck common stock. That motion is pending. On April 16, 2008, Plaintiffs filed a Motion
for Leave to
- 40 -
Supplement the Amended Complaint to add allegations relating to Vytorin and seeking to
add additional defendants, including Richard T. Clark and additional members of the Board of
Directors. That motion is also pending.
As previously disclosed, on October 29, 2004, two individual shareholders made a demand on the
Companys Board to take legal action against Mr. Raymond Gilmartin, former Chairman, President and
Chief Executive Officer and other individuals for allegedly causing damage to the Company with
respect to the allegedly improper marketing of Vioxx. In December 2004, the Special Committee of
the Board of Directors retained the Honorable John S. Martin, Jr. of Debevoise & Plimpton LLP to
conduct an independent investigation of, among other things, the allegations set forth in the
demand. Judge Martins report was made public in September 2006. Based on the Special Committees
recommendation made after careful consideration of the Martin report and the impact that derivative
litigation would have on the Company, the Board rejected the demand. On October 11, 2007, the
shareholders filed a lawsuit in state court in Atlantic County, NJ against current and former
executives and directors of the Company alleging that the Boards rejection of their demand was
unreasonable and improper, and that the defendants breached various duties to the Company in
allowing Vioxx to be marketed.
International Lawsuits
As previously disclosed, in addition to the lawsuits discussed above, the Company has been named as
a defendant in litigation relating to Vioxx in various countries (collectively, the Vioxx Foreign
Lawsuits) in Europe, as well as Canada, Brazil, Argentina, Australia, Turkey, and Israel.
Additional Lawsuits
Based on media reports and other sources, the Company anticipates that additional Vioxx Product
Liability Lawsuits, Vioxx Shareholder Lawsuits and Vioxx Foreign Lawsuits (collectively, the Vioxx
Lawsuits) will be filed against it and/or certain of its current and former officers and directors
in the future.
Insurance
As previously disclosed, the Company has product liability insurance for claims brought in the
Vioxx Product Liability Lawsuits with stated upper limits of approximately $630 million after
deductibles and co-insurance. This insurance provides coverage for legal defense costs and
potential damage amounts in connection with the Vioxx Product Liability Lawsuits. The Companys
insurance coverage with respect to the Vioxx Lawsuits will not be adequate to cover its defense
costs and losses.
As previously disclosed, the Companys upper level excess insurers (which provide excess insurance
potentially applicable to all of the Vioxx Lawsuits) had commenced an arbitration seeking, among
other things, to cancel those policies, to void all of their obligations under those policies and
to raise other coverage issues with respect to the Vioxx Lawsuits. As previously disclosed, in
November 2007, the tribunal in the arbitration ruled in the Companys favor ordering the upper
level excess insurers to comply with their obligations under the policies. The Company recorded a
$455 million gain in the fourth quarter of 2007 as a result of certain other settlements and the
tribunals decision. In addition, prior to recording the gain in the fourth quarter of 2007, as a
result of settlements with, and payments made by, certain of its insurers, the Company had
previously received insurance proceeds of approximately $145 million. In the first quarter of 2008,
the Company resolved substantially all of its claims against lower level excess insurers for
reimbursement for amounts paid in connection with Vioxx Product Liability Lawsuits. As a result of
settlements that have been made, the Company will not recover the full amount of the limits
discussed in the first paragraph of this section. The Company has no additional insurance for the
Vioxx Product Liability Lawsuits.
The Company has Directors and Officers insurance coverage applicable to the Vioxx Securities
Lawsuits and Vioxx Derivative Lawsuits with stated upper limits of approximately $190 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 arbitration referenced above, 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, in November 2004, the Company was advised by the staff of the SEC that it
was commencing an informal inquiry concerning Vioxx. On January 28, 2005, the Company announced
that it received notice that the SEC issued a formal notice of investigation. Also, the Company has
received subpoenas from the U.S. Department of Justice (the DOJ) requesting information related
to the Companys research, marketing and selling activities with respect to Vioxx in a federal
health care investigation under criminal statutes. In addition, as previously disclosed,
investigations are
- 41 -
being conducted by local authorities in certain cities in Europe in order to
determine whether any criminal charges should be brought concerning Vioxx. The Company is
cooperating with these governmental entities in their respective investigations (the Vioxx
Investigations). The Company cannot predict the outcome of these inquiries; however, they could
result in potential civil and/or criminal dispositions.
As previously disclosed, the Company has received a number of Civil Investigative Demands (CID)
from a group of Attorneys General from 31 states and the District of Columbia who are investigating
whether the Company violated state consumer protection laws when marketing Vioxx. The Company is
cooperating with the Attorneys General in responding to the CIDs. As previously disclosed, in the
first quarter of 2008 the Company recorded a $55 million charge in connection with the anticipated
resolution of this investigation. The resolution of this matter is still subject to execution of
definitive agreements.
In addition, the Company received a subpoena in September 2006 from the State of California
Attorney General seeking documents and information related to the placement of Vioxx on
Californias Medi-Cal formulary. The Company is cooperating with the Attorney General in responding
to the subpoena.
Reserves
As discussed above, on November 9, 2007, Merck entered into the Settlement Agreement with the law
firms that comprise the executive committee of the PSC of the federal Vioxx MDL as well as
representatives of plaintiffs counsel in the Texas, New Jersey and California state coordinated
proceedings to resolve state and federal MI and IS claims filed as of that date in the United
States. The Settlement Agreement, which also applies to tolled claims, was signed by the parties
after several meetings with three of the four judges overseeing the coordination of more than
95 percent of the U.S. Vioxx Product
Liability Lawsuits. The Settlement Agreement applies only to
U.S. legal residents and those who allege that their MI or IS occurred in the United States. As a
result of entering into the Settlement Agreement, the Company recorded a pretax charge of
$4.85 billion in 2007 which represents the fixed aggregate amount to be paid to plaintiffs qualifying for
payment under the Settlement Program.
The Company currently anticipates that certain Vioxx Product Liability Lawsuits will be tried in
2008. A trial in the Oregon securities case is scheduled for 2008, but the Company cannot predict
whether this trial will proceed on schedule or the timing of any of the other Vioxx Shareholder
Lawsuit trials. The Company believes that it has meritorious defenses to 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. The Company has not established any reserves for any potential
liability relating to the Vioxx Lawsuits not included in the Settlement Program or the Vioxx
Investigations (other than as set forth above), including for those cases in which verdicts or
judgments have been entered against the Company, and are now in post-verdict proceedings or on
appeal. In each of those cases the Company believes it has strong points to raise on appeal and
therefore that unfavorable outcomes in such cases are not probable. Unfavorable outcomes in the
Vioxx Litigation (as defined below) could have a material adverse effect on the Companys financial position,
liquidity and results of operations.
Legal defense costs expected to be incurred in connection with a loss contingency are accrued when
probable and reasonably estimable. As of December 31, 2007, the Company had a reserve of $5.372
billion which represented the aggregate amount to be paid under the Settlement Agreement and its
future legal defense costs related to (i) the Vioxx Product
Liability Lawsuits, (ii) the Vioxx Shareholder Lawsuits, (iii)
the Vioxx Foreign Lawsuits, and (iv) the Vioxx
Investigations (collectively, the Vioxx Litigation). During the first quarter of 2008, the
Company spent approximately $79 million in the aggregate in legal defense costs related to the
Vioxx Litigation. Also in the first quarter of 2008, as discussed above, the Company recorded a
pretax charge of $55 million in connection with the anticipated resolution of the
previously-disclosed investigation by a group of Attorneys General from 31 states and the District
of Columbia with respect to the Companys marketing of Vioxx. Thus, as of March 31, 2008, the
Company had a reserve of $5.348 billion related to the Vioxx Litigation.
Some of the significant factors considered in the review of the 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 the Settlement Agreement will be consummated, but 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 Product Liability
Lawsuits. Events such as scheduled trials, that are expected to occur throughout 2008 and 2009, and
the inherent inability to predict the ultimate outcomes of such trials and the disposition of Vioxx
Product Liability Lawsuits not participating in or not eligible for the Settlement Program, limit
the Companys ability to reasonably estimate its legal costs beyond 2009.
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While the Company does not anticipate that it will need to increase the reserve every quarter, it
will continue to monitor its legal defense costs and review the adequacy of the associated reserves
and may determine to increase its reserves for legal defense costs 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
As previously disclosed, the Company is a defendant in product liability lawsuits in the United
States involving Fosamax (the Fosamax Litigation). As of March 31, 2008, approximately 465 cases,
which include approximately 940 plaintiff groups had been filed and were pending against Merck in
either federal or state court, including 3 cases which seek class action certification, as well as
damages and medical monitoring. In these actions, plaintiffs allege, among other things, that they
have suffered osteonecrosis of the jaw, generally subsequent to invasive dental procedures such as
tooth extraction or dental implants, and/or delayed healing, in association with the use of
Fosamax. On August 16, 2006, the JPML ordered that the 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 United States District Court for the Southern District of New York. As a
result of the JPML order, approximately 410 of the cases are before Judge Keenan. Judge Keenan has
issued a Case Management Order setting forth a schedule governing the proceedings which focuses
primarily upon resolving the class action certification motions in 2007 and completing fact
discovery in an initial group of 25 cases by August 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. On January 28, 2008, Judge Keenan issued a
further order dismissing with prejudice all class claims asserted in the first four class action
lawsuits filed against Merck that sought personal injury damages and/or medical monitoring relief
on a class wide basis. Discovery is ongoing in both the Fosamax MDL litigation as well as in
various state court cases. The Company intends to defend against these lawsuits.
As of December 31, 2007, the Company had a remaining reserve of approximately $27 million solely
for its future legal defense costs for the Fosamax Litigation. During the first quarter of 2008,
the Company spent approximately $7 million and added $40 million to its reserve. Consequently, as
of March 31, 2008, the Company had a reserve of approximately $60 million. Some of the significant
factors considered in the establishment of the reserve for the Fosamax Litigation legal defense
costs and its adjustment were as follows: the actual costs incurred by the Company thus far; the
development of the Companys legal defense strategy and structure in light of the creation of the
Fosamax MDL; the number of cases being brought against the Company; and the anticipated timing,
progression, and related costs of pre-trial activities in the Fosamax Litigation. The Company will
continue to monitor its legal defense costs and review the adequacy of the associated reserves. Due
to the uncertain nature of litigation, the Company is unable to estimate its costs beyond 2009. The
Company has not established any reserves for any potential liability relating to the Fosamax
Litigation. Unfavorable outcomes in the Fosamax Litigation could have a material adverse effect on
the Companys financial position, liquidity and results of operations.
Commercial/Securities Litigation
As
previously disclosed, since December 2007, the Company and its joint-venture partner, Schering-Plough, have received
several letters addressed to both companies from the House Committee on Energy and Commerce, its
Subcommittee on Oversight and Investigations, and the Ranking Minority Member of the Senate Finance
Committee, collectively seeking a combination of witness interviews, documents and information on a
variety of issues related to the ENHANCE clinical trial, the sale and promotion of Vytorin, as well
as sales of stock by corporate officers. On January 25, 2008, the companies and the MSP Partnership
each received two subpoenas from the New York State Attorney Generals Office seeking similar
information and documents. Merck and Schering-Plough have also each received a letter from the
Office of the Connecticut Attorney General dated February 1, 2008 requesting documents related to
the marketing and sale of Vytorin and Zetia and the timing of disclosures of the results of
ENHANCE. Merck and Schering-Plough also received subpoenas dated April 4, 2008, from the
Office of the New Jersey Attorney General seeking documents related to the ENHANCE trial and the
sale and marketing of Vytorin. The Company is cooperating with these investigations and working
with Schering-Plough to respond to the inquiries. In addition, since mid-January 2008, the Company
has become aware of or been served with approximately 120 civil class action lawsuits alleging
common law and state consumer fraud claims in connection with the MSP Partnerships sale and
promotion of Vytorin and Zetia. Certain of those lawsuits allege personal injuries and/or seek
medical monitoring.
Also, as previously disclosed, on
April 3, 2008, a Merck shareholder filed a putative class action
lawsuit in federal court in the Eastern District of Pennsylvania alleging that Merck and its
Chairman, President and Chief Executive Officer, Richard T. Clark, violated the federal securities
laws. Specifically, the complaint alleges that Merck delayed releasing unfavorable results of a
clinical study regarding the efficacy of Vytorin and that Merck made false and misleading
statements about expected earnings, knowing that once the results of the Vytorin study were
released, sales of Vytorin would decline and Mercks earnings would suffer.
On April 22, 2008, a member of a Merck ERISA plan filed a
putative class action lawsuit against the Company and certain of its
officers and directors alleging they breached their fiduciary duties
under ERISA. Plaintiff alleges that the ERISA plans investment in
Company stock was imprudent because the Companys earnings are
dependent on the commercial success of its cholesterol drug
Vytorin and that defendants knew or should have known that the
results of a scientific study would cause the medical community to
turn to less expensive drugs for cholesterol management. The Company
intends to defend the lawsuits referred to in this section vigorously. Unfavorable
outcomes resulting from the government
- 43 -
investigations or the civil litigation could have a material
adverse effect on the Companys financial position, liquidity and results of operations.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file ANDAs with the FDA
seeking to market generic forms of the Companys products prior to the expiration of relevant
patents owned by the Company. Generic pharmaceutical manufacturers have submitted ANDAs to the FDA
seeking to market in the United States a generic form of Fosamax, Propecia, Prilosec, Nexium,
Singulair, Trusopt, Cosopt and Primaxin prior to the expiration of the Companys (and AstraZenecas
in the case of Prilosec and Nexium) patents concerning these products. In addition, an ANDA has
been submitted to the FDA seeking to market in the United States a generic form of Zetia prior to
the expiration of Schering-Ploughs patent concerning that product. The generic companies ANDAs
generally include allegations of non-infringement, invalidity and unenforceability of the patents.
Generic manufacturers have received FDA approval to market a generic form of Prilosec. The Company
has filed patent infringement suits in federal court against companies filing ANDAs for generic
alendronate (Fosamax), finasteride (Propecia), dorzolamide (Trusopt), montelukast (Singulair),
dorzolamide/timolol (Cosopt), imipenem/cilastatin (Primaxin) and AstraZeneca and the Company have
filed patent infringement suits in federal court against companies filing ANDAs for generic
omeprazole (Prilosec) and esomeprazole (Nexium). Also, the Company and Schering-Plough have filed a
patent infringement suit in federal court against companies filing ANDAs for generic ezetimibe
(Zetia). Similar patent challenges exist in certain foreign jurisdictions. 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 dates 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.
The Company and AstraZeneca received notice in October 2005 that Ranbaxy Laboratories Ltd.
(Ranbaxy) had filed an ANDA for esomeprazole magnesium. The ANDA contains Paragraph IV challenges
to patents on Nexium. On November 21, 2005, the Company and AstraZeneca sued Ranbaxy in the United
States District Court in New Jersey. Accordingly, FDA approval of
Ranbaxys ANDA was stayed for
30 months until April 2008 or until an adverse court decision, if any, whichever may occur earlier.
As previously disclosed, AstraZeneca, Merck and Ranbaxy have entered into a settlement agreement
which provides that Ranbaxy will not bring its generic esomprazole product to market in the United
States until May 27, 2014.
The Company and AstraZeneca received notice in January 2006 that IVAX Pharmaceuticals, Inc.,
subsequently acquired by Teva Pharmaceuticals (Teva), had filed an ANDA for esomeprazole
magnesium. The ANDA contains Paragraph IV challenges to patents on Nexium. On March 8, 2006, the
Company and AstraZeneca sued Teva in the United States District Court in New Jersey. Accordingly,
FDA approval of Tevas ANDA is stayed for 30 months until September 2008 or until an adverse court
decision, if any, whichever may occur earlier. In January 2008, the Company and AstraZeneca sued
Dr. Reddys in the District Court in New Jersey based on Dr. Reddys filing of an ANDA for
esomeprazole magnesium. Accordingly, FDA approval of Dr. Reddys ANDA is stayed for 30 months until
July 2010 or until an adverse court decision, if any, whichever may occur earlier.
Other Litigation
As
previously disclosed, in February 2008, an individual shareholder delivered a letter to the Companys Board of Directors
demanding that the Board take legal action against the responsible individuals to recover the
amounts paid by the Company to resolve the governmental
investigations, which were settled in February 2008. As part of the
settlement, the Company agreed to pay approximately $649 million plus
interest and reasonable fees and expenses to the government.
As previously disclosed, on August 20, 2004, the United States District Court for the District of
New Jersey granted a motion by the Company, Medco Health Solutions, Inc. (Medco Health) and
certain officers and directors to dismiss a shareholder derivative action involving claims related
to the Companys revenue recognition practice for retail co-payments paid by individuals to whom
Medco Health provides pharmaceutical benefits as well as other allegations. The complaint was
dismissed with prejudice. Plaintiffs appealed the decision. On December 15, 2005, the U.S. Court of
Appeals for the Third Circuit upheld most of the District Courts decision dismissing the suit, and
sent the issue of whether the Companys Board of Directors properly refused the shareholder demand
relating to the Companys treatment of retail co-payments back to the District Court for
reconsideration under a different legal standard. Plaintiffs moved to remand their action to state
court on August 18, 2006, and the District Court granted that motion on February 1, 2007. The
shareholder derivative suit was pending before the Superior Court of New Jersey, Chancery Division,
Hunterdon County. All of the remaining issues were dismissed with prejudice in favor of Medco
Health, Merck and the individual defendants on July 31, 2007.
As previously disclosed, prior to the spin-off of Medco Health, the Company and Medco Health agreed
to settle, on a class action basis, a series of lawsuits asserting violations of ERISA (the Gruer
Cases). The Company, Medco Health and
- 44 -
certain plaintiffs counsel filed the settlement agreement
with the federal District Court in New York, where cases commenced by a number of plaintiffs,
including participants in a number of pharmaceutical benefit plans for which Medco Health is the
pharmacy benefit manager, as well as trustees of such plans, have been consolidated. Medco Health
and the Company agreed to the proposed settlement in order to avoid the significant cost and
distraction of prolonged litigation. The proposed class settlement has been agreed to by plaintiffs
in five of the cases filed against Medco Health and the Company. Under the proposed settlement, the
Company and Medco Health have agreed to pay a total of $42.5 million, and Medco Health has agreed
to modify certain business practices or to continue certain specified business practices for a
period of five years. The financial compensation is intended to benefit members of the settlement
class, which includes ERISA plans for which Medco Health administered a pharmacy benefit at any
time since December 17, 1994. The District Court held hearings to hear objections to the fairness
of the proposed settlement and approved the settlement in 2004, but has not yet determined the
number of class member plans that have properly elected not to participate in the settlement. The
settlement becomes final only if and when all appeals have been resolved. Certain class member
plans have indicated that they will not participate in the settlement. Cases initiated by three
such plans and two individuals remain pending in the Southern District of New York. Plaintiffs in
these cases have asserted claims based on ERISA as well as other federal and state laws that are
the same as or similar to the claims that had been asserted by settling class members in the Gruer
Cases. The Company and Medco Health are named as defendants in these cases.
Three notices of appeal were filed and the appellate court heard oral argument in May 2005. On
December 8, 2005, the appellate court issued a decision vacating the District Courts judgment and
remanding the cases to the District Court to allow the District Court to resolve certain
jurisdictional issues. A hearing was held to address such issues on February 24, 2006. The District
Court issued a ruling on August 10, 2006 resolving such jurisdictional issues in favor of the
settling plaintiffs. The class members and the other party that had previously appealed the
District Courts judgment renewed their appeals. On October 4, 2007, the renewed appeals were
affirmed in part and vacated in part by the federal court of appeals. The appeals court remanded
the class settlement for further proceedings in the District Court. The amended settlement and
proposed notice have been filed and a hearing on the settlement is expected in the second quarter
of 2008.
After the spin-off of Medco Health, Medco Health assumed substantially all of the liability
exposure for the matters discussed in the foregoing two paragraphs. These cases are being defended
by Medco Health.
There are various other legal proceedings, principally product liability and intellectual property
suits involving the Company, which are pending. While it is not feasible to predict the outcome of
such proceedings or the proceedings discussed in this Item, in the opinion of the Company, all such
proceedings are either adequately covered by insurance or, if not so covered, 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 Item.
- 45 -
Item 4. Controls and Procedures
Management of the Company, with the participation of its Chief Executive Officer and Chief
Financial Officer, evaluated the effectiveness of the Companys disclosure controls and procedures.
Based on their evaluation, as of the end of the period covered by this Form 10-Q, the Companys
Chief Executive Officer and Chief Financial Officer have concluded that the Companys disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange
Act of 1934, as amended) are effective. There have been no changes in internal control over
financial reporting, for the period covered by this report, that have materially affected, or are
reasonably likely to materially affect, the Companys internal control over financial reporting.
The Company is in the process of implementing an enterprise resource planning system, which
includes transitioning certain financial functions into regionalized shared service environments,
at several of the Companys locations over the coming quarters.
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 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, 2007, as filed on February 28, 2008, the Company discusses in more detail various
important 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.
- 46 -
PART II Other Information
Item 1. Legal Proceedings
Information with respect to certain legal proceedings is incorporated by reference from
Managements Discussion and Analysis of Financial Condition and Results of Operations contained in
Part I of this report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer purchases of equity securities for the three months ended March 31, 2008 were as follows:
ISSUER PURCHASES OF EQUITY SECURITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
Total Number |
|
Average Price |
|
Approximate Dollar Value of Shares |
|
|
of Shares |
|
Paid Per |
|
That May Yet Be Purchased |
Period |
|
Purchased(1) |
|
Share |
|
Under the Plans or Programs(1) |
January 1 - January 31, 2008 |
|
|
8,787,600 |
|
|
$ |
53.98 |
|
|
$ |
4,623.4 |
|
|
February 1 - February 29, 2008 |
|
|
9,760,966 |
|
|
$ |
46.25 |
|
|
$ |
4,171.9 |
|
|
March 1 - March 31, 2008 |
|
|
10,569,140 |
|
|
$ |
42.77 |
|
|
$ |
3,719.9 |
|
|
Total |
|
|
29,117,706 |
|
|
$ |
47.32 |
|
|
$ |
3,719.9 |
|
|
|
|
(1) |
|
All shares purchased during the period were made as part of a plan announced
in July 2002 to purchase $10 billion in Merck shares. |
Item 6. Exhibits
|
|
|
Number |
|
Description |
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Merck & Co., Inc. (May 17, 2007) -
Incorporated by reference to Current Report on Form 8-K dated May 17, 2007 |
|
|
|
3.2
|
|
By-Laws of Merck & Co., Inc. (as amended effective May 31, 2007) -
Incorporated by reference to Current Report on Form 8-K dated May 31, 2007 |
|
|
|
12
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
|
|
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 |
- 47 -
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 5, 2008 |
/s/ Bruce N. Kuhlik
|
|
|
BRUCE N. KUHLIK |
|
|
Executive Vice President and General Counsel |
|
|
|
|
|
|
|
|
|
|
Date: May 5, 2008 |
/s/ John Canan
|
|
|
JOHN CANAN |
|
|
Senior Vice President and Controller |
|
|
- 48 -
EXHIBIT INDEX
|
|
|
Number |
|
Description |
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Merck & Co., Inc. (May 17, 2007) -
Incorporated by reference to Current Report on Form 8-K dated May 17, 2007 |
|
|
|
3.2
|
|
By-Laws of Merck & Co., Inc. (as amended effective May 31, 2007) -
Incorporated by reference to Current Report on Form 8-K dated May 31, 2007 |
|
|
|
12
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
|
|
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 |
- 49 -