10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 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 |
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No. 22-1109110 |
The number of shares of common stock outstanding as of the close of business on September 30, 2008:
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Class
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Number of Shares Outstanding |
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Common Stock
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2,114,186,139 |
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 o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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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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Nine Months Ended |
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September 30, |
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September 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Sales |
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$ |
5,943.9 |
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$ |
6,074.1 |
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$ |
17,817.9 |
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$ |
17,954.8 |
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Costs, Expenses and Other |
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Materials and production |
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1,477.9 |
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1,517.7 |
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4,112.5 |
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4,595.9 |
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Marketing and administrative |
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1,730.3 |
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1,951.4 |
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5,515.0 |
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5,837.2 |
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Research and development |
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1,171.1 |
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1,440.5 |
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3,418.7 |
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3,501.0 |
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Restructuring costs |
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757.5 |
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49.3 |
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929.4 |
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170.9 |
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Equity income from affiliates |
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(665.6 |
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(768.5 |
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(1,840.7 |
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(2,180.2 |
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Other (income) expense, net |
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61.8 |
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(180.9 |
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(2,197.4 |
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(521.2 |
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4,533.0 |
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4,009.5 |
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9,937.5 |
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11,403.6 |
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Income Before Taxes |
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1,410.9 |
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2,064.6 |
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7,880.4 |
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6,551.2 |
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Taxes on Income |
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318.2 |
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539.1 |
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1,716.8 |
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1,644.9 |
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Net Income |
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$ |
1,092.7 |
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$ |
1,525.5 |
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$ |
6,163.6 |
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$ |
4,906.3 |
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Basic Earnings per Common Share |
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$ |
0.51 |
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$ |
0.70 |
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$ |
2.87 |
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$ |
2.26 |
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Earnings per Common Share Assuming Dilution |
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$ |
0.51 |
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$ |
0.70 |
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$ |
2.86 |
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$ |
2.24 |
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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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$ |
1.14 |
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$ |
1.14 |
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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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September 30, |
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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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$ |
5,720.1 |
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$ |
5,336.1 |
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Short-term investments |
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1,121.2 |
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2,894.7 |
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Accounts receivable |
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3,642.6 |
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3,636.2 |
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Inventories (excludes inventories of $415.6 in 2008 and $345.2
in 2007 classified in Other assets see Note 5) |
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2,228.2 |
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1,881.0 |
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Deferred income taxes and other current assets |
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6,706.4 |
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1,297.4 |
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Total current assets |
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19,418.5 |
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15,045.4 |
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Investments |
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6,211.6 |
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7,159.2 |
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Property, Plant and Equipment, at cost, net of allowance for
depreciation of $11,869.1 in 2008 and $12,457.1 in 2007 |
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12,103.2 |
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12,346.0 |
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Goodwill |
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1,438.7 |
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1,454.8 |
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Other Intangibles, Net |
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558.2 |
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713.2 |
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Other Assets |
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8,815.5 |
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11,632.1 |
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$ |
48,545.7 |
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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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$ |
2,994.2 |
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$ |
1,823.6 |
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Trade accounts payable |
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474.7 |
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624.5 |
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Accrued and other current liabilities |
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9,271.2 |
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8,534.9 |
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Income taxes payable |
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879.3 |
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444.1 |
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Dividends payable |
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808.9 |
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831.1 |
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Total current liabilities |
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14,428.3 |
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12,258.2 |
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Long-Term Debt |
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3,938.8 |
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3,915.8 |
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Deferred Income Taxes and Noncurrent Liabilities |
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8,167.9 |
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11,585.3 |
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Minority Interests |
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2,439.7 |
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2,406.7 |
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Stockholders Equity |
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Common stock, one cent par value |
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Authorized - 5,400,000,000 shares |
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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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8,269.5 |
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8,014.9 |
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Retained earnings |
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42,857.3 |
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39,140.8 |
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Accumulated other comprehensive loss |
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(1,033.6 |
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(826.1 |
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50,123.0 |
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46,359.4 |
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Less treasury stock, at cost |
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869,322,536 shares at September 30, 2008 |
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811,005,791 shares at December 31, 2007 |
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30,552.0 |
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28,174.7 |
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Total stockholders equity |
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19,571.0 |
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18,184.7 |
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$ |
48,545.7 |
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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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Nine Months Ended |
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September 30, |
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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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$ |
6,163.6 |
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$ |
4,906.3 |
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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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(1,840.7 |
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(2,180.2 |
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Dividends and distributions from equity affiliates |
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3,750.9 |
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1,626.1 |
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Depreciation and amortization |
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1,157.2 |
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1,489.2 |
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Deferred income taxes |
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(163.8 |
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(391.6 |
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Share-based compensation |
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285.5 |
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250.8 |
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Acquired research |
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325.1 |
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Other |
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461.1 |
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19.8 |
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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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(2,030.2 |
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1,394.0 |
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Net Cash Provided by Operating Activities |
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5,560.9 |
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4,651.4 |
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Cash Flows from Investing Activities |
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Capital expenditures |
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(914.3 |
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(726.3 |
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Purchases of securities and other investments |
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(9,154.8 |
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(7,188.1 |
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Acquisitions of subsidiaries, net of cash acquired |
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(1,135.9 |
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Proceeds from sales of securities and other investments |
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8,456.8 |
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8,311.9 |
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Distribution from AstraZeneca LP |
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1,899.3 |
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Increase in restricted assets |
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(1,662.3 |
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(1,224.1 |
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Other |
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(8.9 |
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0.3 |
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Net Cash Used by Investing Activities |
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(1,384.2 |
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(1,962.2 |
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Cash Flows from Financing Activities |
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Net change in short-term borrowings |
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2,553.3 |
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161.1 |
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Payments on debt |
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(1,391.7 |
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(1,158.9 |
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Purchases of treasury stock |
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(2,515.4 |
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(574.6 |
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Dividends paid to stockholders |
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(2,469.6 |
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(2,478.1 |
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Proceeds from exercise of stock options |
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100.5 |
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473.4 |
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Other |
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(44.2 |
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106.1 |
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Net Cash Used by Financing Activities |
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(3,767.1 |
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(3,471.0 |
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Effect of Exchange Rate Changes on Cash and Cash Equivalents |
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(25.6 |
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75.4 |
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Net Increase (Decrease) in Cash and Cash Equivalents |
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384.0 |
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(706.4 |
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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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$ |
5,720.1 |
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$ |
5,208.3 |
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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 4). The Company is assessing the impact of adopting FAS 157 for
nonfinancial assets and liabilities. In October 2008, the FASB issued Staff Position 157-3,
Determining the Fair Value of a Financial Asset When the Market for That Asset Is Not Active
(FSP 157-3), which clarifies the application of FAS 157 in a market that is not active. FSP
157-3 was effective for the Company at September 30, 2008, and the effect of adoption on the
Companys financial position and results of operations was not material. |
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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 Statement No. 141R, Business Combinations (FAS 141R), and
Statement 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 provides
guidance for the accounting, reporting and disclosure of noncontrolling interests and 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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In May 2008, the FASB issued Statement No. 162, The Hierarchy of Generally Accepted Accounting
Principles (FAS 162), which is effective in the fourth quarter of 2008. FAS 162 identifies
the sources of accounting principles and the framework for selecting the principles used (order
of authority) in the preparation of financial statements that are presented in conformity with
generally accepted accounting standards in the United States. The Company does not expect the
adoption of FAS 162 to have a material impact on its financial statements. |
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In June 2008, the FASB issued Staff Position EITF 03-6-1, Determining Whether Instruments
Granted in Share-Based Payment Transactions Are Participating Securities (FSP EITF 03-6-1),
which is effective January 1, 2009. FSP EITF 03-6-1 clarifies that share-based payment awards
that entitle holders to receive nonforfeitable dividends before they vest will be considered
participating securities and included in the basic earnings per share calculation. The Company
is assessing the impact of adoption of FSP EITF 03-6-1 on its results of operations. |
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2. |
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Restructuring |
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2008 Global Restructuring Program |
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In October 2008, the Company announced a global restructuring program (the 2008 Restructuring
Program) which represents the Companys efforts to reduce its cost structure, increase
efficiency, and enhance competitiveness. As part of the 2008 Restructuring Program, the Company
expects to eliminate approximately 7,200 positions 6,800 active employees and 400 vacancies
across all areas of the Company worldwide by the end of 2011. About 40% of the total reductions
will occur in the United States. To streamline management layers across the Company, Merck will
reduce its total number of senior and mid-level executives by approximately 25%. Merck will
accelerate the rollout of a new, more customer-centric selling model designed to provide Merck
with a meaningful competitive advantage and help physicians, patients and payers improve patient
outcomes. The Company also will make greater use of outside technology resources, centralize
common sales and marketing activities, and consolidate and streamline its operations. Mercks
manufacturing division will further focus its capabilities on core products and outsource
non-core manufacturing. In addition, Merck is enhancing its research operations to expand
access to worldwide external science and incorporate it as a key component of the Companys
pipeline, and ensure a more sustainable pipeline by translating basic research productivity into
late-stage clinical success. As a result, basic research operations will be organized to
consolidate work in support of a given therapeutic area into one of four locations. This will
provide a more efficient use of research facilities and result in the closure of three basic
research sites in Tsukuba, Japan; Pomezia, Italy; and Seattle by the end of 2009. |
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Separation costs are accounted for under FASB Statement No. 112, Employers Accounting for
Postemployment Benefits an amendment of FASB Statement No. 5 and 43 (FAS 112), and FASB
Statement No. 146, Accounting for Costs Associated with Exit or Disposal Activities (FAS 146).
In connection with the 2008 Restructuring Program, separation costs under the Companys
existing severance programs worldwide were accounted for under FAS 112 and recorded in the third
quarter of 2008 to the extent such costs were estimable. The costs related to one-time
termination benefits offered to employees under the 2008 Restructuring Program will be accrued
in the fourth quarter of 2008 as that is when the criteria necessary for accrual under FAS 146
will be met. The Company recorded pretax restructuring costs of $720 million related to the
2008 Restructuring Program in the third quarter of 2008 and anticipates that an additional $250
million to $450 million will be recorded in the fourth quarter of 2008. The 2008 Restructuring
Program is expected to be completed by the end of 2011 with the total pretax costs estimated to
be $1.6 billion to $2.0 billion. The Company estimates that two-thirds of the cumulative pretax
costs will result in future cash outlays, primarily from employee separation expense.
Approximately one-third of the cumulative pretax costs are non-cash, relating primarily to the
accelerated depreciation of facilities to be closed or divested. |
- 6 -
Notes to Consolidated Financial Statements (unaudited) (continued)
2005 Global Restructuring Program
In November 2005, the Company announced a global restructuring program (the 2005 Restructuring
Program) designed to reduce the Companys cost structure, increase efficiency and enhance
competitiveness. As part of the 2005 Restructuring Program, Merck has sold or closed five
manufacturing sites and two preclinical sites and since inception eliminated 10,400 positions
company-wide as of September 30, 2008 comprised of employee separations and the elimination of
contractors and vacant positions. The Company also has sold and closed certain other facilities
and related assets in connection with the 2005 Restructuring Program. Since inception through
September 30, 2008, the Company has recorded total pretax accumulated costs of $2.5 billion
associated with the 2005 Restructuring Program, which is substantially complete.
For segment reporting purposes, restructuring charges are unallocated expenses.
The following table summarizes the charges related to restructuring activities by type of cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
Separation |
|
Accelerated |
|
|
|
|
|
|
|
|
|
Separation |
|
Accelerated |
|
|
|
|
($ in millions) |
|
Costs |
|
Depreciation |
|
Other |
|
Total |
|
Costs |
|
Depreciation |
|
Other |
|
Total |
|
2008 Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
$ |
|
|
|
$ |
3.9 |
|
|
$ |
30.0 |
|
|
$ |
33.9 |
|
|
$ |
|
|
|
$ |
3.9 |
|
|
$ |
30.0 |
|
|
$ |
33.9 |
|
Research and development |
|
|
|
|
|
|
31.0 |
|
|
|
|
|
|
|
31.0 |
|
|
|
|
|
|
|
31.0 |
|
|
|
|
|
|
|
31.0 |
|
Restructuring costs |
|
|
631.0 |
|
|
|
|
|
|
|
24.1 |
|
|
|
655.1 |
|
|
|
631.0 |
|
|
|
|
|
|
|
24.1 |
|
|
|
655.1 |
|
|
|
|
|
631.0 |
|
|
|
34.9 |
|
|
|
54.1 |
|
|
|
720.0 |
|
|
|
631.0 |
|
|
|
34.9 |
|
|
|
54.1 |
|
|
|
720.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
$ |
|
|
|
$ |
23.5 |
|
|
$ |
1.4 |
|
|
$ |
24.9 |
|
|
$ |
|
|
|
$ |
54.6 |
|
|
$ |
1.3 |
|
|
$ |
55.9 |
|
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring costs |
|
|
74.1 |
|
|
|
|
|
|
|
28.3 |
|
|
|
102.4 |
|
|
|
251.1 |
|
|
|
|
|
|
|
23.2 |
(1) |
|
|
274.3 |
|
|
|
|
|
74.1 |
|
|
|
23.5 |
|
|
|
29.7 |
|
|
|
127.3 |
|
|
|
251.1 |
|
|
|
54.6 |
|
|
|
24.5 |
|
|
|
330.2 |
|
|
|
|
$ |
705.1 |
|
|
$ |
58.4 |
|
|
$ |
83.8 |
|
|
$ |
847.3 |
|
|
$ |
882.1 |
|
|
$ |
89.5 |
|
|
$ |
78.6 |
|
|
$ |
1,050.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
Separation |
|
Accelerated |
|
|
|
|
|
|
|
|
|
Separation |
|
Accelerated |
|
|
|
|
($ in millions) |
|
Costs |
|
Depreciation |
|
Other |
|
Total |
|
Costs |
|
Depreciation |
|
Other |
|
Total |
|
2005 Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
$ |
|
|
|
$ |
127.4 |
|
|
$ |
1.4 |
|
|
$ |
128.8 |
|
|
$ |
|
|
|
$ |
363.7 |
|
|
$ |
1.9 |
|
|
$ |
365.6 |
|
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.1 |
) |
|
|
(0.1 |
) |
Restructuring costs |
|
|
36.7 |
|
|
|
|
|
|
|
12.6 |
|
|
|
49.3 |
|
|
|
121.7 |
|
|
|
|
|
|
|
49.2 |
|
|
|
170.9 |
|
|
|
|
$ |
36.7 |
|
|
$ |
127.4 |
|
|
$ |
14.0 |
|
|
$ |
178.1 |
|
|
$ |
121.7 |
|
|
$ |
363.7 |
|
|
$ |
51.0 |
|
|
$ |
536.4 |
|
|
|
|
|
(1) |
|
Includes proceeds from the sales of facilities in connection with the 2005 Restructuring Program. |
Separation costs are associated with actual headcount reductions, as well as those headcount
reductions that were probable and could be reasonably estimated. In the third quarter of 2008,
approximately 1,700 positions were eliminated and in the third quarter of 2007 approximately 275
positions were eliminated. In the first nine months of 2008, approximately 3,200 positions were
eliminated compared with approximately 1,130 positions in the first nine months of 2007. All of
these position eliminations were related to the 2005 Restructuring Program.
Accelerated depreciation costs primarily relate to manufacturing and research facilities to be
sold or closed as part of the programs.
Other activity of $83.8 million and $14.0 million for the third quarter of 2008 and 2007,
respectively, and $78.6 million and $51.0 million for the first nine months of 2008 and 2007,
respectively, reflects costs that include termination charges associated with the Companys
pension and other postretirement benefit plans (see Note 10), asset
abandonment, shut-down and other related costs. Other activity for the first nine months of
2008 also reflects pretax gains of $54.4 million resulting from sales of facilities and related
assets.
- 7 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The following table summarizes the charges and spending relating to restructuring activities for
the nine months ended September 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Separation |
|
Accelerated |
|
|
|
|
($ in millions) |
|
Costs |
|
Depreciation |
|
Other |
|
Total |
|
2008 Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring reserves as of January 1, 2008 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Expense |
|
|
631.0 |
|
|
|
34.9 |
|
|
|
54.1 |
|
|
|
720.0 |
|
(Payments) receipts, net |
|
|
|
|
|
|
|
|
|
|
(10.3 |
) |
|
|
(10.3 |
) |
Non-cash activity |
|
|
|
|
|
|
(34.9 |
) |
|
|
(43.8 |
) |
|
|
(78.7 |
) |
|
Restructuring reserves as of September 30, 2008 (1) |
|
$ |
631.0 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
631.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring reserves as of January 1, 2008 |
|
$ |
231.5 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
231.5 |
|
Expense |
|
|
251.1 |
|
|
|
54.6 |
|
|
|
24.5 |
|
|
|
330.2 |
|
(Payments) receipts, net |
|
|
(307.5 |
) |
|
|
|
|
|
|
(12.9 |
) (2) |
|
|
(320.4 |
) |
Non-cash activity |
|
|
|
|
|
|
(54.6 |
) |
|
|
(11.6 |
) |
|
|
(66.2 |
) |
|
Restructuring reserves as of September 30, 2008 (1) |
|
$ |
175.1 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
175.1 |
|
|
|
|
|
(1) |
|
The cash outlays associated with the restructuring reserve for the 2008
Restructuring Program are expected to be completed by the end of 2011. The cash outlays
associated with the remaining restructuring reserve for the 2005 Restructuring Program are
expected to be largely completed by the end of 2009. |
|
(2) |
|
Includes proceeds from the sales of facilities in connection with the 2005
Restructuring Program. |
3. Research Collaborations
In September 2008, Merck and Japan Tobacco Inc. (JT) signed a worldwide licensing agreement to
develop and commercialize JTT-305, an investigational oral osteoanabolic (bone growth
stimulating) agent for the treatment of osteoporosis, a disease which reduces bone density and
strength and results in an increased risk of bone fractures. JTT-305 is an investigational oral
calcium sensing receptor antagonist that is currently being evaluated by JT in Phase II clinical
trials in Japan for its effect on increasing bone density and is in Phase I clinical trials
outside of Japan. Under the terms of the agreement, Merck gains worldwide rights, except for
Japan, to develop and commercialize JTT-305 and certain other related compounds.
JT will receive an upfront payment of $85 million, which the
Company will record as Research and development
expense upon closing in the fourth quarter of 2008, and is eligible to receive additional cash payments upon achievement of certain
milestones associated with the development and approval of a drug candidate covered by this
agreement. JT will also be eligible to receive royalties from sales of any drug candidates that
receive marketing approval.
The license agreement between Merck and JT will remain in effect until expiration of all royalty
and milestone obligations, and may be terminated in the event of an uncured material breach by
the other party. The agreement may also be terminated by Merck without cause before initial
commercial sale of JTT-305 by giving six months prior notice to JT, and thereafter by giving one
year prior notice thereof to JT. The license agreement may also be terminated immediately by
Merck if Merck determines due to safety and/or efficacy concerns based on available scientific
evidence to cease development of JTT-305 and/or to withdraw JTT-305 from the market on a
permanent basis.
4. 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. 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. In October 2008, the FASB issued FSP 157-3, which clarifies the
application of FAS 157 in a market that is not active. FSP 157-3 was effective for the Company
at September 30, 2008, and the effect of adoption on the Companys financial position and results of operations
was not material. 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
- 8 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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 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 values are determined using pricing models with
inputs that are observable in the market or can be derived principally from or corroborated by
observable market data.
Level 3 - Unobservable inputs that are supported by little or no market activity and that are
financial instruments whose values are determined using pricing models, discounted cash flow
methodologies, or similar techniques, as well as instruments for which the determination of fair
value requires significant judgment or estimation. The Companys Level 3 assets mainly include
mortgage-backed and asset-backed securities, as well as certain corporate notes and bonds with
limited market activity. At September 30, 2008, $183.7 million, or approximately 1.7%, of the
Companys investment securities were categorized as Level 3 fair value assets (all of which were
pledged under certain collateral arrangements (see Note 12)).
If the inputs used to measure the financial assets and liabilities fall within the different
levels described above, the categorization is based on the lowest level input that is
significant to the fair value measurement of the instrument.
Financial assets and liabilities measured at fair value on a recurring basis as of September 30,
2008 are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using |
|
|
Quoted Prices |
|
Significant |
|
|
|
|
|
|
In Active |
|
Other |
|
Significant |
|
|
|
|
Markets for |
|
Observable |
|
Unobservable |
|
|
|
|
Identical Assets |
|
Inputs |
|
Inputs |
|
|
($ in millions) |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
|
Total |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate notes and bonds |
|
$ |
|
|
|
$ |
3,081.9 |
|
|
$ |
|
|
|
$ |
3,081.9 |
|
U.S. government and agency securities |
|
|
|
|
|
|
2,620.3 |
|
|
|
|
|
|
|
2,620.3 |
|
Mortgage-backed securities (1) |
|
|
|
|
|
|
555.6 |
|
|
|
|
|
|
|
555.6 |
|
Foreign government bonds |
|
|
|
|
|
|
456.4 |
|
|
|
|
|
|
|
456.4 |
|
Asset-backed securities (1) |
|
|
|
|
|
|
303.3 |
|
|
|
|
|
|
|
303.3 |
|
Equity securities |
|
|
104.6 |
|
|
|
86.4 |
|
|
|
|
|
|
|
191.0 |
|
Commercial paper |
|
|
|
|
|
|
124.3 |
|
|
|
|
|
|
|
124.3 |
|
|
Total investments |
|
|
104.6 |
|
|
|
7,228.2 |
|
|
|
|
|
|
|
7,332.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets (2) |
|
|
|
|
|
|
3,036.9 |
|
|
|
183.7 |
|
|
|
3,220.6 |
|
Derivative assets |
|
|
|
|
|
|
471.7 |
|
|
|
|
|
|
|
471.7 |
|
|
Total Assets |
|
|
104.6 |
|
|
|
10,736.8 |
|
|
|
183.7 |
|
|
|
11,025.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative liabilities |
|
$ |
|
|
|
$ |
74.7 |
|
|
$ |
|
|
|
$ |
74.7 |
|
|
|
|
|
(1) |
|
Mortgage-backed securities represent AAA rated securities issued or
unconditionally guaranteed as to payment of principal and interest by U.S. government agencies.
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. |
|
(2) |
|
Other assets represent a portion of the pledged collateral discussed in Note 7
and Note 12. Level 2 Other assets are comprised primarily of $1,411.1 million in corporate
notes and bonds, $750.7 million in municipal securities, $352.3 million in mortgage-backed
securities, $270.0 million of asset-backed securities and $227.8 million in commercial paper. |
- 9 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Level 3 Valuation Techniques:
Financial assets are considered Level 3 when their fair values are determined using pricing
models, discounted cash flow methodologies or similar techniques and at least one significant
model assumption or input is unobservable. Level 3 financial assets also include certain
investment securities for which there is limited market activity such that the determination of
fair value requires significant judgment or estimation. The Companys Level 3 investment
securities at September 30, 2008, primarily include mortgage-backed and asset-backed securities,
as well as certain corporate notes and bonds for which there was a decrease in the observability
of market pricing for these investments. These securities were valued primarily using pricing
models for which management understands the methodologies. These models incorporate transaction
details such as contractual terms, maturity, timing and amount of future cash inflows, as well
as assumptions about liquidity and credit valuation adjustments of marketplace participants at
September 30, 2008.
The table below provides a summary of the changes in fair value, including net transfers in
and/or out, of all financial assets measured at fair value on a recurring basis using
significant unobservable inputs (Level 3):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Realized and |
|
|
|
|
|
|
Losses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized Gains/ |
|
|
|
|
|
|
Recorded in |
|
|
|
|
|
|
Net |
|
Purchases, |
|
(Losses) Included in: |
|
|
|
|
|
|
Earnings for |
|
|
Beginning |
|
Transfers |
|
Sales, |
|
|
|
|
|
Compre- |
|
Ending |
|
|
Level 3 Assets |
|
|
Balance |
|
In to |
|
Settlements, |
|
|
|
|
|
hensive |
|
Balance |
|
|
Still Held at |
($ in millions) |
|
July 1 |
|
Level 3 |
|
Net |
|
Earnings (1) |
|
Income |
|
September 30 |
|
|
September 30 |
|
|
|
|
Other assets |
|
$ |
179.5 |
|
|
$ |
32.6 |
|
|
$ |
(28.3 |
) |
|
$ |
1.3 |
|
|
$ |
(1.4 |
) |
|
$ |
183.7 |
|
|
|
$ |
(0.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Realized and |
|
|
|
|
|
|
Losses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized Losses |
|
|
|
|
|
|
Recorded in |
|
|
|
|
|
|
Net |
|
Purchases, |
|
Included in: |
|
|
|
|
|
|
Earnings for |
|
|
Beginning |
|
Transfers |
|
Sales, |
|
|
|
|
|
Compre- |
|
Ending |
|
|
Level 3 Assets |
|
|
Balance |
|
(Out) of |
|
Settlements, |
|
|
|
|
|
hensive |
|
Balance |
|
|
Still Held at |
($ in millions) |
|
January 1 |
|
Level 3 |
|
Net |
|
Earnings (1) |
|
Income |
|
September 30 |
|
|
September 30 |
|
|
|
|
Other assets |
|
$ |
958.6 |
|
|
$ |
(712.2 |
) |
|
$ |
(52.9 |
) |
|
$ |
(6.9 |
) |
|
$ |
(2.9 |
) |
|
$ |
183.7 |
|
|
|
$ |
(7.2 |
) |
Other debt securities |
|
|
314.5 |
|
|
|
(314.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,273.1 |
|
|
$ |
(1,026.7 |
) |
|
$ |
(52.9 |
) |
|
$ |
(6.9 |
) |
|
$ |
(2.9 |
) |
|
$ |
183.7 |
|
|
|
$ |
(7.2 |
) |
|
|
|
|
|
|
|
(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 September 30, 2008, $183.7 million
of the investment securities associated with the redemption-in-kind were classified in Level 3
as the securities contained at least one significant input which was unobservable.
- 10 -
5. |
|
Inventories |
|
|
|
Inventories consisted of: |
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Finished goods |
|
$ |
463.6 |
|
|
$ |
382.9 |
|
Raw materials and work in process |
|
|
2,071.9 |
|
|
|
1,732.2 |
|
Supplies |
|
|
108.3 |
|
|
|
111.1 |
|
|
Total (approximates current cost) |
|
|
2,643.8 |
|
|
|
2,226.2 |
|
Reduction to LIFO cost for domestic inventories |
|
|
|
|
|
|
|
|
|
|
|
$ |
2,643.8 |
|
|
$ |
2,226.2 |
|
|
Recognized as: |
|
|
|
|
|
|
|
|
Inventories |
|
$ |
2,228.2 |
|
|
$ |
1,881.0 |
|
Other assets |
|
$ |
415.6 |
|
|
$ |
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. |
|
6. |
|
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 |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Merck/Schering-Plough |
|
$ |
400.2 |
|
|
$ |
480.9 |
|
|
$ |
1,158.2 |
|
|
$ |
1,293.1 |
|
AstraZeneca LP |
|
|
139.1 |
|
|
|
181.2 |
|
|
|
331.6 |
|
|
|
608.3 |
|
Other (1) |
|
|
126.3 |
|
|
|
106.4 |
|
|
|
350.9 |
|
|
|
278.8 |
|
|
|
|
$ |
665.6 |
|
|
$ |
768.5 |
|
|
$ |
1,840.7 |
|
|
$ |
2,180.2 |
|
|
|
|
|
(1) |
|
Primarily reflects results from Merial Limited, Sanofi Pasteur MSD and Johnson &
Johnson°Merck Consumer Pharmaceuticals Company. |
|
|
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 |
- 11 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
research and development expenses are generally shared equally by the Partners, after adjusting
for earned milestones. |
|
|
|
See Note 8 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 provided 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. In April 2008, the Partners announced that they had received a non-approvable letter
from the U.S. Food and Drug Administration (FDA) for the proposed fixed combination of
loratadine/montelukast. In June 2008, the Partners announced the withdrawal of the New Drug
Application for the loratadine/montelukast combination tablet. The companies also terminated
the respiratory joint venture. This action had no impact on the business of the cholesterol
joint venture. As a result of the termination of the respiratory joint venture, the Company was
obligated to Schering-Plough in the amount of $105 million as specified in the joint venture
agreements. This resulted in a charge of $43 million during the second quarter of 2008,
included in Equity income from affiliates. The remaining amount is being amortized over the
remaining patent life of Zetia through 2016. |
|
|
|
Summarized financial information for the MSP Partnership is as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Sales |
|
$ |
1,101.5 |
|
|
$ |
1,300.0 |
|
|
$ |
3,486.9 |
|
|
$ |
3,731.7 |
|
|
Vytorin |
|
|
567.2 |
|
|
|
693.0 |
|
|
|
1,810.5 |
|
|
|
2,003.2 |
|
Zetia |
|
|
534.3 |
|
|
|
607.0 |
|
|
|
1,676.4 |
|
|
|
1,728.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production costs |
|
|
41.0 |
|
|
|
60.9 |
|
|
|
144.6 |
|
|
|
162.1 |
|
Other expense, net |
|
|
283.5 |
|
|
|
302.9 |
|
|
|
929.6 |
|
|
|
948.9 |
|
|
Income before taxes |
|
$ |
777.0 |
|
|
$ |
936.2 |
|
|
$ |
2,412.7 |
|
|
$ |
2,620.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mercks share of income before taxes (1) |
|
$ |
383.9 |
|
|
$ |
481.9 |
|
|
$ |
1,124.9 |
|
|
$ |
1,297.7 |
|
|
|
|
|
(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, including
milestone payments. |
|
|
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 in the first quarter of 2008. |
|
|
|
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 Inc.
(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. |
- 12 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
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 $2.6 billion in the first
quarter of 2008. |
|
|
Summarized financial information for AZLP is as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Sales |
|
$ |
1,306.2 |
|
|
$ |
1,486.0 |
|
|
$ |
3,983.0 |
|
|
$ |
4,873.1 |
|
Materials and production costs |
|
|
690.2 |
|
|
|
607.8 |
|
|
|
2,016.6 |
|
|
|
2,562.5 |
|
Other expense, net |
|
|
335.0 |
|
|
|
315.5 |
|
|
|
1,072.7 |
|
|
|
870.3 |
|
|
Income before taxes |
|
$ |
281.0 |
|
|
$ |
562.7 |
|
|
$ |
893.7 |
|
|
$ |
1,440.3 |
|
|
7. |
|
Debt and Financial Instruments |
|
|
In January and February 2008, the Company terminated four interest rate swap contracts with
notional amounts of $250 million each, and in September 2008 terminated an interest rate swap
contract with a notional amount of $500 million. These swaps had effectively converted its $1.0
billion, 4.75% fixed-rate notes due 2015 and its $500 million, 4.375% fixed-rate notes due 2013
to variable rate debt. As a result of the swap terminations, the Company received $128.3
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 August 2008, the Company executed a $4.1 billion letter of credit agreement with a financial
institution which satisfied certain conditions set forth in the U.S. Vioxx Settlement Agreement
(see Note 8). The Company pledged collateral to the financial institution of approximately $5.1
billion pursuant to the terms of the letter of credit agreement. Although the amount of assets
pledged as collateral is set by the letter of credit agreement and such assets are held in
custody by a third party, the assets are managed by the Company. The Company considers the
assets pledged under the letter of credit agreement to be restricted. As a result, $2.1 billion
and $1.4 billion of cash and investments, respectively, were classified as restricted current
assets and $1.6 billion of investments were classified as restricted non-current assets. The
letter of credit amount and required collateral balances will decline as payments (after the
first $750 million) under the Settlement Agreement are made. (See Note 12 for a discussion of
other restricted asset activities.) As of September 30, 2008, $3.7 billion was recorded within
Deferred income taxes and other current assets and $1.4 billion was classified as Other assets. |
|
|
Also in March 2008, the Company settled the $1.38 billion Astra Note due in 2008 (see Note 6). |
|
|
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. |
|
|
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. |
- 13 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
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 September 30, 2008, the Company had been served or was aware that it had been named as a
defendant in approximately 11,575 lawsuits, which include approximately 29,200 plaintiff groups,
alleging personal injuries resulting from the use of Vioxx, and in approximately 246 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 9,000 lawsuits representing approximately 23,400 plaintiff groups
are or are slated to be in the federal MDL and approximately 725 lawsuits representing
approximately 725 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 25,100
plaintiffs had been dismissed as of September 30, 2008. Of these, there have been over 3,650
plaintiffs whose claims were dismissed with prejudice (i.e., they cannot be brought again)
either by plaintiffs themselves or by the courts. Over 21,450 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, approximately 13,575 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. |
|
|
|
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 Plaintiffs Steering
Committee (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
myocardial infarction (MI) and ischemic stroke (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% 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. |
|
|
|
Merck will pay a fixed aggregate amount of $4.85 billion into two funds ($4.0 billion for MI
claims and $850 million for IS claims) 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 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. The Settlement
Agreement provided that Mercks payment obligations would 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% of their clients
who allege either MI or IS and (2) by June 30, 2008, plaintiffs enroll in the Settlement Program
at least 85% 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. Under the terms of the Settlement Agreement,
Merck could exercise a right to walk away from the Settlement Agreement if the thresholds and
other requirements were not met. The Company waived that right as of August 4, 2008. The
waiver of that right triggered Mercks obligation to pay a fixed total of $4.85 billion.
Payments will be made in installments into the settlement fund. The first payment of $500
million was made in August 2008 and an additional payment of $250 million was made in October
2008. Additional payments will be made on a periodic basis going forward, when and as needed
to fund payments of claims and administrative expenses. |
|
|
|
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.
The distribution of interim payments to qualified claimants |
- 14 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
began in August 2008 and will continue on a rolling basis until all claimants who qualify for an
interim payment are paid. Final payments will be made after the examination of all of the
eligible claims has been completed. |
|
|
|
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) required plaintiffs with cases pending as of November 9,
2007 to preserve and produce records and serve expert reports; and
(4) required 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 October 30, 2008, the last day for enrollment in the
Settlement Program, more than 48,100 of the approximately 48,325
individuals who were eligible for the Settlement Program and whose
claims are not 1) dismissed, 2) expected to be dismissed in the near
future, or 3) tolled claims that appear to have been abandoned have
submitted some or all of the materials required for enrollment in the
Settlement 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 99% of the eligible MI and
IS claims previously registered with the Settlement Program. |
|
|
|
On April 14, 2008 and June 3, 2008, two groups of various private insurance companies and health
plans filed suit against BrownGreer, the claims administrator for the
Settlement Program (the Claims Administrator), and U.S. Bancorp, escrow agent for the Settlement Program
(the AvMed and Greater New York Benefit Fund suits). 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. Each group sought temporary
restraining orders and preliminary injunctions. Judge Fallon denied these requests. In AvMed,
the defendants moved to sever the claims of the named plaintiffs and, in Greater New York
Benefit Fund, to strike the class allegations. Judge Fallon granted these motions. AvMed has
appealed both of these decisions. The Fifth Circuit will hear argument on AvMeds appeal on
November 4, 2008. Greater New York Benefit Fund has served a notice of appeal. |
|
|
|
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 third 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 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 March 20, 2008, plaintiffs moved to dismiss their
appeal, seeking instead to vacate the trial courts decision. Merck filed an opposition to
plaintiffs motion. On May 15, 2008, the Court of Appeals issued an order granting plaintiffs
motion to dismiss the appeal, but denying plaintiffs motion to vacate the order dismissing the
claim. On July 25, 2008, the appeal was dismissed by agreement of the parties. |
|
|
|
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 |
- 15 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
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 appealed
the judgments in both cases and the Appellate Division held oral argument on both cases on
January 16, 2008. On May 29, 2008, the New Jersey Appellate Division vacated the consumer fraud
awards in both cases on the grounds that the Product Liability Act provides the sole remedy for
personal injury claims. The Appellate Division also vacated the McDarby punitive damage award
on the grounds that it is preempted and vacated the attorneys fees and costs awarded under the
Consumer Fraud Act in both cases. The Court upheld the McDarby compensatory award. The Company
has filed with the Supreme Court of New Jersey a petition to appeal those parts of the trial
courts rulings that the Appellate Division affirmed. Plaintiffs filed a cross-petition to
appeal those parts of the trial courts rulings that the Appellate Division reversed. Those
petitions are currently pending. On October 8, 2008, the Supreme
Court of New Jersey granted Mercks petition for certification
of appeal, limited solely to the issue of whether the Federal Food,
Drug and Cosmetic Act preempts state law tort claims predicated on the
alleged inadequacy of warnings contained in Vioxx labeling
that was approved by the FDA. The court denied the plaintiffs
cross-petition. |
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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. On May
29, 2008, the Texas Court of Appeals reversed the trial courts judgment and issued a judgment
in favor of Merck. The Court of Appeals found the evidence to be legally insufficient on the
issue of causation. Plaintiffs have filed a motion for rehearing en banc in the Court of
Appeals. Merck filed a response in October 2008. |
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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 even though under Texas law, in
this case, potential punitive damages were capped at $750,000. On May 14, 2008, the San Antonio
Court of Appeals reversed the judgment and rendered a judgment in favor of Merck. On May 29,
2008, plaintiffs filed a motion for rehearing, which is currently pending. |
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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. |
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At the parties request, Judge Higbee has extended the briefing schedule in Martin-Kleinman v.
Merck, which is a putative consumer class action pending in New Jersey Superior Court. The
Court will set a new schedule after resolving certain discovery issues. |
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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. The majority of these cases are at early
procedural stages. On June 12, 2008, a Missouri state court certified a class of Missouri
plaintiffs seeking reimbursement for out-of-pocket costs relating to Vioxx. The plaintiffs do
not allege any personal injuries from taking Vioxx. The Company filed a petition for
interlocutory review on June 23, 2008, which was granted on July 30, 2008. During the pendency
of the appeal, discovery is proceeding in the lower court. |
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Plaintiffs also have filed a class action in California state court seeking class certification
of California third-party payors and end-users. The parties are engaged in class certification
discovery and briefing. |
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As previously reported, the Company has also been named as a defendant in separate lawsuits
brought by the Attorneys General of nine 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 |
- 16 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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theories, including state consumer fraud and/or fair business practices or Medicaid fraud statutes, including civil penalties. |
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In addition, the Company has been named in six other lawsuits containing similar allegations
filed by (or on behalf of) governmental entities seeking the reimbursement of alleged Medicaid
expenditures for Vioxx or statutory penalties tied to such expenditures. Those lawsuits are (1)
a class action filed by Santa Clara County, California on behalf of all similarly situated
California counties, (2) separate actions filed by Erie County, Chautauqua County, and Orange
County, New York, (3) a qui tam action brought by a resident of the District of Columbia, and
(4) a qui tam action brought by a resident of Florida. With the exception of a case filed by
the Texas Attorney General (which remains in Texas state court and is currently scheduled for
trial in September 2009), a case recently filed by the Michigan Attorney General (which has been
removed to federal court and will likely be transferred to the federal MDL shortly) and the
recently-filed Orange County and Florida cases (which will be removed to federal court and will
likely be transferred to the federal MDL), the rest of the actions described in this paragraph
have been transferred to the federal MDL and are in the discovery phase. |
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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 appealed Judge Cheslers decision to the
United States Court of Appeals for the Third Circuit. On September 9, 2008, the Third Circuit
issued an opinion reversing Judge Cheslers order and remanding the case to the district court.
On September 23, 2008, Merck filed a petition seeking rehearing en banc which was denied. |
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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. |
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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. The Court denied the motion in June 2008 and closed the case. Plaintiffs have
appealed Judge Cheslers decision to the United States Court of Appeals for the Third Circuit. |
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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 |
- 17 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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(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 October 6, 2008 defendants filed a motion for judgment on the pleadings seeking dismissal of
the complaint. |
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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. The current and former executive and director
defendants filed motions to dismiss the complaint in June 2008. Those motions are pending. |
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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, The Philippines,
Turkey, and Israel. |
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On May 30, 2008, the provincial court of Queens Bench in Saskatchewan, Canada entered an order
certifying a class of Vioxx users in Canada, except those in Quebec. The class includes
individual purchasers who allege inducement to purchase by unfair marketing practices;
individuals who allege Vioxx was not of acceptable quality, defective or not fit for the purpose
of managing pain associated with approved indications; or ingestors who claim Vioxx caused or
exacerbated a cardiovascular or gastrointestinal condition. On June 17, 2008, the Court of
Appeal for Saskatchewan granted the Company leave to appeal the certification order and the
appeal is pending before that court. On July 28, 2008, the Superior court in Ontario decided to
certify an overlapping class of Vioxx users in Canada, except those in Quebec and Saskatchewan,
who allege negligence and an entitlement to elect to waive the tort. The Companys motion for
leave to appeal that decision is pending before the Ontario Divisional Court. Earlier, in
November 2006, the Superior court in Quebec authorized the institution of a class action on
behalf of all individuals who, in Québec, consumed Vioxx and suffered damages arising out of its
ingestion. As of September 30, 2008, the plaintiffs have not instituted an action based upon
that authorization. |
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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. |
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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. Through an
arbitration proceeding and negotiated settlements, the Company received an aggregate of
approximately $590 million in product liability insurance proceeds relating to the Vioxx Product
Liability Lawsuits, plus approximately $45 million in fees and interest payments. The Company
has no additional insurance for 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. |
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The Company also 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 |
- 18 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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arbitration proceeding 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. |
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Investigations
As previously disclosed, in November 2004, the Company was
advised by the staff of the Securities and Exchange Commission (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. |
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As previously disclosed, on May 20, 2008, the Company reached civil settlements with Attorneys
General from 29 states and the District of Columbia to fully resolve previously disclosed
investigations under state consumer protection laws related to past activities for Vioxx. As
part of the civil resolution of these investigations, Merck paid a total of $58 million to be
divided among the 29 states and the District of Columbia. In April 2008, Merck announced it had
taken a pretax charge in the first quarter of $55 million in anticipation of this settlement.
The agreement also includes compliance measures that supplement policies and procedures
previously established by the Company. |
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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. |
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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% 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. |
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The Company currently anticipates that Vioxx Product Liability Lawsuits will be tried in the
future. 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. |
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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 half of 2008, the Company spent
approximately $156 million in the aggregate in legal defense costs related to the Vioxx
Litigation. In the third quarter of 2008, the Company spent approximately $66 million in the
aggregate in legal defense costs related to the Vioxx
Litigation. In addition, in the third quarter the Company paid
$500 million into the settlement fund in connection with the Settlement |
- 19 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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Agreement referred to above. Thus, as of September 30, 2008, the Company had a reserve of approximately $4.649
billion related to the Vioxx Litigation. |
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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,
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
trials, which may
occur in 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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The Company 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. |
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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 September 30, 2008, approximately
700 cases, which include approximately 1,143 plaintiff groups had been filed and were pending
against Merck in either federal or state court, including two 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 583 of the cases are before Judge Keenan. Judge Keenan issued a Case
Management Order (and various amendments thereto) 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 October 1, 2008. Briefing
and argument on plaintiffs motions for certification of medical monitoring classes were
completed in 2007 and Judge Keenan issued an order denying the motions on January 3, 2008. 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. In October 2008, Judge Keenan
issued an order requiring that Daubert motions be filed in May 2009 and scheduling trials in the
first three cases in the MDL for August 2009, October 2009, and January 2010, respectively. |
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In addition, in July 2008, an application was made by the Atlantic County Superior Court of New
Jersey requesting that all of the Fosamax cases pending in New Jersey be considered for mass
tort designation and centralized management before one judge in New Jersey. On October 6, 2008,
the New Jersey Supreme Court ordered that all pending and future actions filed in New Jersey
arising out of the use of Fosamax and seeking damages for existing dental and jaw-related
injuries, including osteonecrosis of the jaw, but not solely seeking medical monitoring, be
designated as a mass tort for centralized management purposes before Judge Carol Higbee in
Atlantic County Superior Court. Judge Higbee has scheduled an initial case management
conference in the New Jersey matters for November 14, 2008. |
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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. |
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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 half of 2008,
the Company spent approximately $17 million and added $40 million to its reserve. In the third
quarter, the Company spent approximately $8 million. Consequently, as of September 30, 2008,
the Company had a reserve of approximately $42 million. Some of the significant factors
considered in the establishment and ongoing assessment of the reserve for the Fosamax Litigation
legal defense costs 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 the |
- 20 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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completion of the first three federal trials discussed above. 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. |
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Vytorin/Zetia 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 (O&I), 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. In addition, on August 21 and September 2, 2008, respectively, the companies received
additional letters from O&I seeking certain information and documents related to the SEAS
clinical trial. As previously disclosed, the companies have each received subpoenas from the
New York and New Jersey State Attorneys General Offices and a letter from the Connecticut
Attorney General seeking similar information and documents. In addition, the Company has
received five Civil Investigative Demands (CIDs) from a multistate group of 35 State Attorneys
General who are jointly investigating whether the companies violated state consumer protection
laws when marketing Vytorin. Finally, on September 10, 2008, the Company received a letter from
the Civil Division of the U.S. Department of Justice informing it that the DOJ is investigating
whether the companies conduct relating to the promotion of Vytorin caused false claims to be
submitted to federal health care programs. 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 140 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. |
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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.
This suit has since been withdrawn and re-filed in
the District of New Jersey and has been consolidated with another
federal securities lawsuit under the caption In re Merck &
Co., Inc. Vytorin Securities Litigation. An amended consolidated
complaint was filed on October 6, 2008 and names as defendants
Merck; Merck/Schering-Plough Pharmaceuticals, LLC; and certain of the
Companys officers and directors.
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. Since that time, there have been other similar ERISA
lawsuits filed against the Company in the District of New Jersey, and
all of those lawsuits have been consolidated under the caption In
re Merck & Co., Inc. Vytorin ERISA Litigation. Plaintiffs in these suits allege 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. |
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Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file Abbreviated New Drug
Applications (ANDAs) with the FDA seeking to market generic forms of the Companys products
prior to the expiration of relevant patents owned by the Company. Generic pharmaceutical
manufacturers have submitted ANDAs to the FDA seeking to market in the United States a generic
form of Propecia, Prilosec, Nexium, Singulair 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 finasteride
(Propecia), montelukast (Singulair),
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. |
- 21 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
As previously disclosed, in February 2007, the Company received a notice from Teva
Pharmaceuticals (Teva), a generic company, indicating that it had filed an ANDA for
montelukast and that it is challenging the U.S. patent that is listed for Singulair. On April
2, 2007, the Company filed a patent infringement action against Teva. The lawsuit automatically
stays FDA approval of Tevas ANDA for 30 months or until an adverse court decision, if any,
whichever may occur earlier. A trial in this matter has been scheduled to begin on February 23,
2009. |
|
|
|
Other Litigation
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. |
|
9. |
|
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 |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Pretax share-based compensation expense |
|
$ |
86.8 |
|
|
$ |
72.7 |
|
|
$ |
285.5 |
|
|
$ |
250.9 |
|
Income tax benefits |
|
|
(26.7 |
) |
|
|
(22.8 |
) |
|
|
(88.8 |
) |
|
|
(79.1 |
) |
|
Total share-based compensation
expense, net of tax |
|
$ |
60.1 |
|
|
$ |
49.9 |
|
|
$ |
196.7 |
|
|
$ |
171.8 |
|
|
|
|
During the first nine months of 2008 and 2007, the Company granted 34.5 million options and 33.7
million options, respectively, related to its annual grant and other grants. The weighted
average fair value of options granted for the first nine months of 2008 and 2007 was $9.89 and
$9.30 per option, respectively, and was determined using the following assumptions: |
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
September 30, |
|
|
2008 |
|
2007 |
|
Expected dividend yield |
|
|
3.5 |
% |
|
|
3.4 |
% |
Risk-free interest rate |
|
|
2.7 |
% |
|
|
4.4 |
% |
Expected volatility |
|
|
30.8 |
% |
|
|
24.5 |
% |
Expected life (years) |
|
|
6.1 |
|
|
|
5.7 |
|
|
|
|
At September 30, 2008, there was $515.1 million of total pretax unrecognized compensation
expense related to nonvested stock options, RSU and PSU awards which will be recognized over a
weighted average period of 2.2 years. For segment reporting, share-based compensation costs are
unallocated expenses. |
- 22 -
Notes to Consolidated Financial Statements (unaudited) (continued)
10. |
|
Pension and Other Postretirement Benefit Plans |
|
|
The Company has defined benefit pension plans covering eligible employees in the United States
and in certain of its international subsidiaries. The net cost of such plans consisted of the
following components: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Service cost |
|
$ |
90.1 |
|
|
$ |
90.3 |
|
|
$ |
263.4 |
|
|
$ |
275.3 |
|
Interest cost |
|
|
105.4 |
|
|
|
99.9 |
|
|
|
318.8 |
|
|
|
284.5 |
|
Expected return on plan assets |
|
|
(142.8 |
) |
|
|
(123.1 |
) |
|
|
(427.7 |
) |
|
|
(366.7 |
) |
Net amortization |
|
|
19.3 |
|
|
|
44.0 |
|
|
|
62.1 |
|
|
|
112.5 |
|
Termination benefits |
|
|
24.4 |
|
|
|
2.5 |
|
|
|
42.9 |
|
|
|
18.5 |
|
Curtailments |
|
|
8.1 |
|
|
|
|
|
|
|
11.3 |
|
|
|
|
|
Settlements |
|
|
2.5 |
|
|
|
|
|
|
|
2.5 |
|
|
|
|
|
|
|
|
$ |
107.0 |
|
|
$ |
113.6 |
|
|
$ |
273.3 |
|
|
$ |
324.1 |
|
|
|
|
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 |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Service cost |
|
$ |
18.4 |
|
|
$ |
25.8 |
|
|
$ |
55.9 |
|
|
$ |
68.1 |
|
Interest cost |
|
|
28.2 |
|
|
|
28.8 |
|
|
|
84.5 |
|
|
|
80.7 |
|
Expected return on plan assets |
|
|
(33.2 |
) |
|
|
(37.4 |
) |
|
|
(97.7 |
) |
|
|
(98.0 |
) |
Net amortization |
|
|
(5.2 |
) |
|
|
(7.5 |
) |
|
|
(16.6 |
) |
|
|
(12.5 |
) |
Termination benefits |
|
|
2.9 |
|
|
|
0.2 |
|
|
|
7.1 |
|
|
|
3.7 |
|
Curtailments |
|
|
(12.3 |
) |
|
|
|
|
|
|
(12.9 |
) |
|
|
(3.9 |
) |
|
|
|
$ |
(1.2 |
) |
|
$ |
9.9 |
|
|
$ |
20.3 |
|
|
$ |
38.1 |
|
|
|
|
In connection with restructuring actions (see Note 2), the Company recorded termination charges
for the three and nine months ended September 30, 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 net
curtailment losses on its pension plans for the three and nine months ended September 30, 2008
and curtailment gains on its other postretirement benefit plans for the three and nine months
ended September 30, 2008 and the nine months ended September 30, 2007. In addition, the Company
recorded settlement losses on its pension plans for the three and nine months ended September
30, 2008. |
- 23 -
Notes to Consolidated Financial Statements (unaudited) (continued)
11. |
|
Other (Income) Expense, Net |
|
|
Other (income) expense, net, consisted of: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Interest income |
|
$ |
(171.3 |
) |
|
$ |
(186.9 |
) |
|
$ |
(484.2 |
) |
|
$ |
(540.9 |
) |
Interest expense |
|
|
71.4 |
|
|
|
91.5 |
|
|
|
194.6 |
|
|
|
297.2 |
|
Exchange losses (gains) |
|
|
52.3 |
|
|
|
(8.3 |
) |
|
|
73.6 |
|
|
|
(39.8 |
) |
Minority interests |
|
|
31.2 |
|
|
|
30.6 |
|
|
|
93.9 |
|
|
|
92.0 |
|
Other, net |
|
|
78.2 |
|
|
|
(107.8 |
) |
|
|
(2,075.3 |
) |
|
|
(329.7 |
) |
|
|
|
$ |
61.8 |
|
|
$ |
(180.9 |
) |
|
$ |
(2,197.4 |
) |
|
$ |
(521.2 |
) |
|
|
|
Other, net for the nine months ended September 30, 2008 primarily reflects an aggregate gain
from AZLP of $2.2 billion (see Note 6) 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, recognized losses of $108 million, including
$88 million of losses in the third quarter, in the Companys investment portfolio and a $58
million charge related to the resolution of an investigation into whether the Company violated
consumer protection laws with respect to the sales and marketing of Vioxx (see Note 8). Other,
net for the first nine months of 2007 primarily reflects the favorable impact of gains on sales
of assets and product divestitures, as well as a net gain on the settlements of certain patent
disputes. Interest paid for the nine months ended September 30, 2008 and 2007 was $181.2
million and $318.4 million, respectively. |
|
|
The effective tax rate of 22.6% for the third quarter of 2008 reflects the favorable impact of
restructuring charges. The effective tax rate of 21.8% for the first nine months of 2008
reflects a net favorable impact of approximately 2 percentage points which includes favorable
impacts relating to second quarter tax settlements that resulted in a reduction of the Companys
liability for unrecognized tax benefits of approximately $200 million, the first quarter
realization of foreign tax credits and year-to-date restructuring costs, largely offset by an
unfavorable impact resulting from the AZLP gain (see Note 6) being fully taxable in the United
States at a combined federal and state tax rate of approximately 36.3%. 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 first
quarter based on a change in the Companys repatriation plans. The effective tax rates of 26.1%
for the third quarter of 2007 and 25.1% for the first nine months of 2007 reflect the impact of
acquired research expense which is not deductible for tax purposes, as well as the favorable
impact of restructuring costs. |
- 24 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
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 $1.5 billion (U.S.
dollars) plus interest of approximately $1.0 billion (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 $21 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 $1.3 billion at September 30, 2008. During the first
nine months of 2008, approximately $400 million of cash and cash equivalents in the collateral
account was transferred out and a corresponding amount of investments was transferred in. 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. |
|
|
The weighted average common shares used in the computations of basic earnings per common share
and earnings per common share assuming dilution are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
(shares in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Average common shares outstanding |
|
|
2,128.5 |
|
|
|
2,170.5 |
|
|
|
2,144.4 |
|
|
|
2,168.2 |
|
Common shares issuable(1) |
|
|
7.1 |
|
|
|
22.3 |
|
|
|
12.4 |
|
|
|
19.2 |
|
|
Average common shares outstanding assuming dilution |
|
|
2,135.6 |
|
|
|
2,192.8 |
|
|
|
2,156.8 |
|
|
|
2,187.4 |
|
|
|
|
|
(1) |
|
Issuable primarily under share-based compensation plans. |
|
|
For the three months ended September 30, 2008 and 2007, 227.5 million and 124.5 million,
respectively, and for the nine months ended September 30, 2008 and 2007, 202.1 million and 177.1
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. |
|
|
Comprehensive income was $994.7 million and $1,584.5 million for the three months ended
September 30, 2008 and 2007, respectively, and was $5,956.1 million and $5,017.0 million for the
nine months ended September 30, 2008 and 2007, respectively. |
- 25 -
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 majority of the Companys aggregate 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 |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Segment revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
4,804.6 |
|
|
$ |
4,765.2 |
|
|
$ |
14,622.1 |
|
|
$ |
14,539.0 |
|
Vaccines and Infectious Diseases segment |
|
|
1,085.9 |
|
|
|
1,236.0 |
|
|
|
3,098.1 |
|
|
|
3,213.1 |
|
Other segment revenues |
|
|
21.2 |
|
|
|
44.9 |
|
|
|
65.3 |
|
|
|
125.6 |
|
|
|
|
$ |
5,911.7 |
|
|
$ |
6,046.1 |
|
|
$ |
17,785.5 |
|
|
$ |
17,877.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment profits:(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
3,165.5 |
|
|
$ |
3,305.1 |
|
|
$ |
9,397.5 |
|
|
$ |
9,977.6 |
|
Vaccines and Infectious Diseases segment |
|
|
772.7 |
|
|
|
815.7 |
|
|
|
2,042.9 |
|
|
|
1,941.1 |
|
Other segment profits |
|
|
98.6 |
|
|
|
112.9 |
|
|
|
363.9 |
|
|
|
395.5 |
|
|
|
|
$ |
4,036.8 |
|
|
$ |
4,233.7 |
|
|
$ |
11,804.3 |
|
|
$ |
12,314.2 |
|
|
|
|
|
(1) |
|
Includes the majority of Equity income from affiliates. |
- 26 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
Sales (1) of the Companys products were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Singulair |
|
$ |
1,029.3 |
|
|
$ |
1,018.1 |
|
|
$ |
3,214.6 |
|
|
$ |
3,111.9 |
|
Cozaar/Hyzaar |
|
|
888.3 |
|
|
|
813.6 |
|
|
|
2,676.3 |
|
|
|
2,458.8 |
|
Fosamax |
|
|
353.9 |
|
|
|
725.2 |
|
|
|
1,234.8 |
|
|
|
2,253.0 |
|
Januvia |
|
|
378.5 |
|
|
|
184.6 |
|
|
|
984.4 |
|
|
|
415.3 |
|
Cosopt/Trusopt |
|
|
208.6 |
|
|
|
196.8 |
|
|
|
627.4 |
|
|
|
575.0 |
|
Zocor |
|
|
157.2 |
|
|
|
217.8 |
|
|
|
513.1 |
|
|
|
654.2 |
|
Maxalt |
|
|
136.4 |
|
|
|
125.0 |
|
|
|
388.3 |
|
|
|
341.5 |
|
Propecia |
|
|
107.9 |
|
|
|
99.2 |
|
|
|
320.6 |
|
|
|
292.8 |
|
Arcoxia |
|
|
96.8 |
|
|
|
76.1 |
|
|
|
294.1 |
|
|
|
245.2 |
|
Vasotec/Vaseretic |
|
|
82.1 |
|
|
|
119.5 |
|
|
|
271.5 |
|
|
|
368.5 |
|
Proscar |
|
|
80.9 |
|
|
|
89.6 |
|
|
|
251.9 |
|
|
|
328.0 |
|
Janumet |
|
|
100.7 |
|
|
|
18.6 |
|
|
|
231.5 |
|
|
|
42.9 |
|
Emend |
|
|
68.2 |
|
|
|
48.9 |
|
|
|
193.3 |
|
|
|
143.6 |
|
Other pharmaceutical (2) |
|
|
519.1 |
|
|
|
575.4 |
|
|
|
1,734.2 |
|
|
|
1,980.2 |
|
Vaccine and infectious disease product sales
included in the Pharmaceutical segment (3) |
|
|
596.7 |
|
|
|
456.8 |
|
|
|
1,686.1 |
|
|
|
1,328.1 |
|
|
Pharmaceutical segment revenues |
|
|
4,804.6 |
|
|
|
4,765.2 |
|
|
|
14,622.1 |
|
|
|
14,539.0 |
|
|
Vaccines (4) and Infectious Diseases: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gardasil |
|
|
401.0 |
|
|
|
418.4 |
|
|
|
1,117.1 |
|
|
|
1,141.3 |
|
RotaTeq |
|
|
134.5 |
|
|
|
171.3 |
|
|
|
502.4 |
|
|
|
375.4 |
|
Zostavax |
|
|
11.2 |
|
|
|
61.2 |
|
|
|
150.8 |
|
|
|
150.7 |
|
ProQuad/M-M-R II/Varivax |
|
|
430.4 |
|
|
|
428.5 |
|
|
|
973.8 |
|
|
|
1,018.1 |
|
Hepatitis vaccines |
|
|
36.2 |
|
|
|
68.4 |
|
|
|
107.9 |
|
|
|
219.5 |
|
Other vaccines |
|
|
80.6 |
|
|
|
96.5 |
|
|
|
222.8 |
|
|
|
284.6 |
|
Primaxin |
|
|
187.6 |
|
|
|
185.6 |
|
|
|
591.5 |
|
|
|
568.4 |
|
Cancidas |
|
|
147.9 |
|
|
|
135.2 |
|
|
|
457.4 |
|
|
|
403.2 |
|
Isentress |
|
|
107.3 |
|
|
|
5.4 |
|
|
|
231.1 |
|
|
|
11.9 |
|
Crixivan/Stocrin |
|
|
68.5 |
|
|
|
72.3 |
|
|
|
222.8 |
|
|
|
229.9 |
|
Invanz |
|
|
71.1 |
|
|
|
49.5 |
|
|
|
197.0 |
|
|
|
137.4 |
|
Other infectious disease |
|
|
6.3 |
|
|
|
0.5 |
|
|
|
9.6 |
|
|
|
0.8 |
|
Vaccine and infectious disease product sales
included in the Pharmaceutical segment (3) |
|
|
(596.7 |
) |
|
|
(456.8 |
) |
|
|
(1,686.1 |
) |
|
|
(1,328.1 |
) |
|
Vaccines and Infectious Diseases segment revenues |
|
|
1,085.9 |
|
|
|
1,236.0 |
|
|
|
3,098.1 |
|
|
|
3,213.1 |
|
|
Other segment (5) |
|
|
21.2 |
|
|
|
44.9 |
|
|
|
65.3 |
|
|
|
125.6 |
|
|
Total segment revenues |
|
|
5,911.7 |
|
|
|
6,046.1 |
|
|
|
17,785.5 |
|
|
|
17,877.7 |
|
|
Other (6) |
|
|
32.2 |
|
|
|
28.0 |
|
|
|
32.4 |
|
|
|
77.1 |
|
|
|
|
$ |
5,943.9 |
|
|
$ |
6,074.1 |
|
|
$ |
17,817.9 |
|
|
$ |
17,954.8 |
|
|
|
|
|
(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 $375.2 million
and $416.3 million for the third quarter of 2008 and 2007, respectively, and was $1,235.7
million and $1,438.2 million for the first nine months of 2008 and 2007, respectively. |
|
(3) |
|
Sales of vaccine and infectious disease products by non-U.S. subsidiaries are
included in the Pharmaceutical segment. |
|
(4) |
|
These amounts do not reflect sales of vaccines sold in most major European
markets through the Companys joint venture, Sanofi Pasteur MSD, the results of which are
reflected in Equity income from affiliates. These amounts do, however, reflect supply
sales to Sanofi Pasteur MSD. |
|
(5) |
|
Includes other non-reportable human and animal health segments. |
|
(6) |
|
Other revenues are primarily comprised of miscellaneous corporate revenues, sales
related to divested products or businesses and other supply sales not included in segment
results. |
- 27 -
Notes to Consolidated Financial Statements (unaudited) (continued)
|
|
A reconciliation of segment profits to Income Before Taxes is as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Segment profits |
|
$ |
4,036.8 |
|
|
$ |
4,233.7 |
|
|
$ |
11,804.3 |
|
|
$ |
12,314.2 |
|
Other profits |
|
|
21.1 |
|
|
|
10.3 |
|
|
|
(6.8 |
) |
|
|
40.3 |
|
Adjustments |
|
|
72.1 |
|
|
|
86.6 |
|
|
|
271.7 |
|
|
|
258.7 |
|
Unallocated: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
171.3 |
|
|
|
186.9 |
|
|
|
484.2 |
|
|
|
540.9 |
|
Interest expense |
|
|
(71.4 |
) |
|
|
(91.5 |
) |
|
|
(194.6 |
) |
|
|
(297.2 |
) |
Equity income from affiliates |
|
|
32.9 |
|
|
|
47.9 |
|
|
|
31.7 |
|
|
|
180.6 |
|
Depreciation and amortization |
|
|
(367.0 |
) |
|
|
(458.0 |
) |
|
|
(1,079.4 |
) |
|
|
(1,388.5 |
) |
Research and development |
|
|
(1,171.1 |
) |
|
|
(1,440.5 |
) |
|
|
(3,418.7 |
) |
|
|
(3,501.0 |
) |
Gain on distribution from
AstraZeneca LP |
|
|
|
|
|
|
|
|
|
|
2,222.7 |
|
|
|
|
|
Other expenses, net |
|
|
(1,313.8 |
) |
|
|
(510.8 |
) |
|
|
(2,234.7 |
) |
|
|
(1,596.8 |
) |
|
|
|
$ |
1,410.9 |
|
|
$ |
2,064.6 |
|
|
$ |
7,880.4 |
|
|
$ |
6,551.2 |
|
|
|
|
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.
|
- 28 -
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Operating Results
Sales
Worldwide sales were $5.94 billion for the third quarter of 2008, a decline of 2% compared with the
third quarter of 2007, primarily attributable to a 6% unfavorable effect from volume, partially
offset by a 4% favorable effect from foreign exchange. The revenue decline in the third quarter
largely reflects lower sales of Fosamax for the treatment and prevention of osteoporosis. Fosamax
and Fosamax Plus D lost market exclusivity for substantially all formulations in the United States
in February 2008 and April 2008, respectively. Also contributing to the decline were lower sales
of vaccines, including Zostavax, a vaccine to help prevent shingles (herpes zoster), RotaTeq, a
vaccine to help protect against rotavirus gastroenteritis in infants and children, and Haemophilus
influenzae type b (HIB) and hepatitis vaccines. Revenue was also negatively impacted by lower
sales of Zocor, the Companys statin for modifying cholesterol which lost U.S. market exclusivity
in 2006, and lower revenue from the Companys relationship with AstraZeneca LP (AZLP). These
declines were partially offset by higher sales of Januvia and Janumet for the treatment of type 2
diabetes, Isentress for the treatment of HIV infection and Cozaar/Hyzaar* for the treatment of
hypertension.
Worldwide sales were $17.82 billion for the first nine months of 2008, a decline of 1% compared
with the first nine months of 2007, primarily attributable to a 4% unfavorable effect from volume
and a 1% unfavorable effect from price changes, offset by a 4% favorable effect from foreign
exchange. The revenue decline for the first nine months of 2008 reflects lower sales of Fosamax,
decreased revenues from the Companys relationship with AZLP, lower sales of Zocor and lower sales
of vaccines, including hepatitis and HIB vaccines. Partially offsetting these declines were higher
sales of Januvia and Janumet, Isentress, Cozaar/Hyzaar, RotaTeq and Singulair, a medicine indicated
for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis.
* Cozaar and Hyzaar are registered trademarks of E.I. duPont de Nemours & Company, Wilmington, Delaware.
- 29 -
Sales of the Companys products were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Singulair |
|
$ |
1,029.3 |
|
|
$ |
1,018.1 |
|
|
$ |
3,214.6 |
|
|
$ |
3,111.9 |
|
Cozaar/Hyzaar |
|
|
888.3 |
|
|
|
813.6 |
|
|
|
2,676.3 |
|
|
|
2,458.8 |
|
Fosamax |
|
|
353.9 |
|
|
|
725.2 |
|
|
|
1,234.8 |
|
|
|
2,253.0 |
|
Januvia |
|
|
378.5 |
|
|
|
184.6 |
|
|
|
984.4 |
|
|
|
415.3 |
|
Cosopt/Trusopt |
|
|
208.6 |
|
|
|
196.8 |
|
|
|
627.4 |
|
|
|
575.0 |
|
Zocor |
|
|
157.2 |
|
|
|
217.8 |
|
|
|
513.1 |
|
|
|
654.2 |
|
Maxalt |
|
|
136.4 |
|
|
|
125.0 |
|
|
|
388.3 |
|
|
|
341.5 |
|
Propecia |
|
|
107.9 |
|
|
|
99.2 |
|
|
|
320.6 |
|
|
|
292.8 |
|
Arcoxia |
|
|
96.8 |
|
|
|
76.1 |
|
|
|
294.1 |
|
|
|
245.2 |
|
Vasotec/Vaseretic |
|
|
82.1 |
|
|
|
119.5 |
|
|
|
271.5 |
|
|
|
368.5 |
|
Proscar |
|
|
80.9 |
|
|
|
89.6 |
|
|
|
251.9 |
|
|
|
328.0 |
|
Janumet |
|
|
100.7 |
|
|
|
18.6 |
|
|
|
231.5 |
|
|
|
42.9 |
|
Emend |
|
|
68.2 |
|
|
|
48.9 |
|
|
|
193.3 |
|
|
|
143.6 |
|
Other pharmaceutical (1) |
|
|
519.1 |
|
|
|
575.4 |
|
|
|
1,734.2 |
|
|
|
1,980.2 |
|
Vaccine and infectious disease product sales
included in the Pharmaceutical segment (2) |
|
|
596.7 |
|
|
|
456.8 |
|
|
|
1,686.1 |
|
|
|
1,328.1 |
|
|
Pharmaceutical segment revenues |
|
|
4,804.6 |
|
|
|
4,765.2 |
|
|
|
14,622.1 |
|
|
|
14,539.0 |
|
|
Vaccines (3) and Infectious Diseases: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gardasil |
|
|
401.0 |
|
|
|
418.4 |
|
|
|
1,117.1 |
|
|
|
1,141.3 |
|
RotaTeq |
|
|
134.5 |
|
|
|
171.3 |
|
|
|
502.4 |
|
|
|
375.4 |
|
Zostavax |
|
|
11.2 |
|
|
|
61.2 |
|
|
|
150.8 |
|
|
|
150.7 |
|
ProQuad/M-M-R II/Varivax |
|
|
430.4 |
|
|
|
428.5 |
|
|
|
973.8 |
|
|
|
1,018.1 |
|
Hepatitis vaccines |
|
|
36.2 |
|
|
|
68.4 |
|
|
|
107.9 |
|
|
|
219.5 |
|
Other vaccines |
|
|
80.6 |
|
|
|
96.5 |
|
|
|
222.8 |
|
|
|
284.6 |
|
Primaxin |
|
|
187.6 |
|
|
|
185.6 |
|
|
|
591.5 |
|
|
|
568.4 |
|
Cancidas |
|
|
147.9 |
|
|
|
135.2 |
|
|
|
457.4 |
|
|
|
403.2 |
|
Isentress |
|
|
107.3 |
|
|
|
5.4 |
|
|
|
231.1 |
|
|
|
11.9 |
|
Crixivan/Stocrin |
|
|
68.5 |
|
|
|
72.3 |
|
|
|
222.8 |
|
|
|
229.9 |
|
Invanz |
|
|
71.1 |
|
|
|
49.5 |
|
|
|
197.0 |
|
|
|
137.4 |
|
Other infectious disease |
|
|
6.3 |
|
|
|
0.5 |
|
|
|
9.6 |
|
|
|
0.8 |
|
Vaccine and infectious disease product sales
included in the Pharmaceutical segment (2) |
|
|
(596.7 |
) |
|
|
(456.8 |
) |
|
|
(1,686.1 |
) |
|
|
(1,328.1 |
) |
|
Vaccines and Infectious Diseases segment revenues |
|
|
1,085.9 |
|
|
|
1,236.0 |
|
|
|
3,098.1 |
|
|
|
3,213.1 |
|
|
Other segment (4) |
|
|
21.2 |
|
|
|
44.9 |
|
|
|
65.3 |
|
|
|
125.6 |
|
|
Total segment revenues |
|
|
5,911.7 |
|
|
|
6,046.1 |
|
|
|
17,785.5 |
|
|
|
17,877.7 |
|
|
Other (5) |
|
|
32.2 |
|
|
|
28.0 |
|
|
|
32.4 |
|
|
|
77.1 |
|
|
|
|
$ |
5,943.9 |
|
|
$ |
6,074.1 |
|
|
$ |
17,817.9 |
|
|
$ |
17,954.8 |
|
|
|
|
|
(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 $375.2 million and $416.3 million for the third
quarter of 2008 and 2007, respectively, and was $1,235.7 million and $1,438.2 million for the
first nine months 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, however, 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
- 30 -
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 $529.7 million and $492.4
million for the three months ended September 30, 2008 and 2007, respectively, and by $1,581.7
million and $1,536.1 million for the nine months ended September 30, 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% for both the third quarter and first nine months
of 2008 to $4.80 billion and $14.62 billion, respectively, compared with the corresponding periods
of 2007. These results reflect growth of Januvia, Janumet, Isentress and Cozaar/Hyzaar, offset by
declines in Fosamax, Zocor and supply sales to AZLP.
Worldwide sales for Singulair were $1.03 billion for the third quarter of 2008, representing an
increase of 1% over the third quarter of 2007. Sales for the first nine months of 2008 reached
$3.21 billion, a 3% increase over the comparable prior year period. Sales in the third quarter and
first nine months of 2008 reflect the continued demand for asthma and seasonal and perennial
allergic rhinitis medications. Sales performance for the quarter and year-to-date period benefited
from higher sales outside the United States, including the positive effect of foreign exchange and
volume growth in Europe and Japan. Sales performance in the United States also reflects the impact
of the switch of a competing allergic rhinitis product to over-the-counter status in the United
States in early 2008, the timing and public reaction to the U.S. Food and Drug Administration
(FDA) early communication regarding a very limited number of post-marketing adverse event reports
which created uncertainty in the marketplace, and a shorter and milder spring allergy season.
Singulair continues to be the number one prescribed branded product in the U.S. respiratory market.
Global sales of Cozaar and Hyzaar were $888.3 million for the third quarter of 2008, an increase of
9% compared with the third quarter of 2007. Sales for the first nine months of 2008 were $2.68
billion, an increase of 9% compared with the first nine months of 2007. The increase in both
periods was driven in part by the positive effect of foreign exchange and strong performance of
Hyzaar in Japan (marketed as Preminent). Cozaar and Hyzaar are among the leading medicines in the
growing angiotensin receptor blocker class.
Global sales for Fosamax and Fosamax Plus D (marketed as Fosavance throughout the European Union
(EU) and as Fosamac in Japan) were $353.9 million for the third quarter of 2008 and were $1.23
billion for the first nine months of 2008, representing declines of 51% and 45%, respectively, over
the comparable prior year periods of 2007. Since substantially all formulations of these medicines
have lost U.S. market exclusivity, the Company is experiencing a significant decline in sales in
the United States within the Fosamax franchise and the Company expects such declines to continue.
Global sales of Januvia, Mercks dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of
type 2 diabetes, were $378.5 million in the third quarter of 2008 compared with $184.6 million for
the third quarter of 2007. Sales for the first nine months of 2008 were $984.4 million compared
with $415.3 for the first nine months of 2007. Januvia was approved by the FDA in October 2006 and
by the European Commission (EC) in March 2007. Januvia continues to be the second leading
branded oral anti-diabetic agent in terms of new prescription share. DPP-4 inhibitors represent a
class of prescription medications that improve blood sugar control in patients with type 2 diabetes
by enhancing a natural body system called the incretin system, which helps to regulate glucose by
affecting the beta cells and alpha cells in the pancreas.
In September 2008, new data analyses from five new studies were presented at the 44th
Annual Meeting of the European Association for the Study of Diabetes. These data showed initial
combination therapy with Januvia and metformin provided improvements in blood sugar levels as
measured by A1C (a measure of a persons average blood glucose over a two-month to three-month
period) over two years of treatment and was generally well tolerated. Also presented at the
meeting was a separate, new pooled analysis of 6,139 patients that showed that Januvia was
generally well tolerated in clinical trials up to two years in duration. Three additional studies
further demonstrated the safety and efficacy profile of Januvia as an add-on to other oral diabetes
treatments and efficacy when analyzed based on different baseline characteristics.
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 $100.7 million for the third quarter of 2008 compared with $18.6 million for the
third quarter of 2007. Sales for the first nine months of 2008 were $231.5 million compared with
$42.9 million for the same period of 2007. Janumet, launched in the United States in April 2007,
was approved, as an adjunct to diet and exercise, to improve blood sugar control in adult patients
with type 2
- 31 -
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 July 2008, Janumet was approved for
marketing in the EU, Iceland and Norway.
Worldwide sales of Zocor, Mercks statin for modifying cholesterol, declined 28% in the third
quarter of 2008 compared with the third quarter of 2007 and 22% for the first nine months of 2008
over the corresponding period 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 third quarter and first nine
months of 2008 compared with the same periods of 2007 include Arcoxia for the treatment of
arthritis and pain, Emend for the 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, Maxalt to treat migraine pain, Cosopt to treat elevated
intraocular pressure in patients with open-angle glaucoma or ocular hypertension, and Propecia for
male pattern hair loss.
In September 2008, Merck confirmed that the EC adopted the recommendation of the European Medicines
Agency to approve Arcoxia 90 mg once daily as a new treatment for ankylosing spondylitis, maintain
the 90 mg dose for rheumatoid arthritis, and modify the contraindications and warnings sections of
the label for treating and monitoring patients with hypertension. In Europe, Arcoxia is indicated
for the treatment of osteoarthritis (30 mg or 60 mg), rheumatoid arthritis (90 mg) and acute gouty
arthritis (120 mg). National approval procedures to implement the new indication and prescribing
information are underway in the 27 member states of the EU. Arcoxia is approved and launched in 69
countries in Europe, Latin America and the Asia-Pacific region.
In October 2008, Merck terminated its Phase II/III clinical study evaluating Zolinza in combination
with paclitaxel and carboplatin in patients with Stage IIIB or Stage IV non-small cell lung cancer.
The decision follows the recommendations of an independent Data Safety Monitoring Board (DSMB),
which met on October 14, 2008 for a pre-planned interim analysis of the study. The DSMB
recommended that the study, which had completed Phase II enrollment, be discontinued due to a lack
of improvement in progression-free survival and a higher incidence of serious adverse experiences
and discontinuations of therapy in the Zolinza plus carboplatin and paclitaxel arm. Merck
currently remains blinded to the data and will evaluate the data once it has been fully analyzed.
As lung cancer is a leading cause of cancer deaths worldwide, Merck is committed to further
researching Zolinza in combination with other chemotherapy agents.
Also in
October 2008, the patent that provided U.S. market exclusivity for Trusopt and Cosopt
expired. The Company expects significant declines in U.S. sales of these products.
During the first quarter of 2008, Merck divested its remaining ownership of Aggrastat in foreign
markets to Iroko Pharmaceuticals.
Also 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 declined 12% to $1.09 billion in the third
quarter of 2008 from $1.24 billion in the third quarter of 2007 primarily due to lower sales of
Zostavax, Gardasil, RotaTeq, hepatitis and HIB vaccines, partially offset by sales of Isentress.
Sales for the first nine months of 2008 declined 4% to $3.10 billion from $3.21 billion for the
first nine months of 2007 primarily due to lower sales of hepatitis and HIB vaccines, Gardasil and
other viral vaccines, which include Varivax,
M-M-R II and ProQuad, partially offset by sales of
Isentress and growth in RotaTeq.
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
$401.0 million for the third quarter of 2008, a decline of 4% compared with the third quarter of
2007 and were $1.12 billion for the first nine months of 2008, a decline of 2% over the comparable
period of 2007. Sales performance reflects lower sales
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domestically, partially offset by growth
outside the United States. Sales growth outside the United States was aided by the adoption of
school-based programs in all Canadian provinces, which was the
primary driver of a $34 million increase in sales
in Canada in the third quarter of 2008 compared with the third quarter
of 2007. Based on market research, the third quarter 2008
performance for Gardasil in the
United States was driven by a generally consistent monthly vaccination rate among 19 to 26 year old women
over the past year, and while the annual vaccination rate of the remaining 13 to 18 year olds
increased, the overall number of first dose vaccinations declined because of the early success in
vaccinating this age group following launch. Also, utilization during the back to school season
appears to have been tempered by media coverage over the summer on post-marketing reports.
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, vulvar and vaginal cancers, precancerous or dysplastic lesions, and genital warts
caused by HPV types 6, 11, 16 and 18.
In September 2008, the FDA approved Gardasil for the prevention of vulvar and vaginal cancers
caused by HPV types 16 and 18. The approval is based on data from a combined analysis of three
studies that demonstrated the efficacy and safety of Gardasil in more than 15,000 patients.
In June 2008, the FDA issued a complete response letter regarding the supplemental biologics
license application (sBLA) for the use of Gardasil in women ages 27 through 45. The agency
issued the letter to advise that it has completed its review of the submission and that there are
issues that preclude approval of the supplement within the expected review timeframe. Merck
discussed with the FDA their questions related to this application and responded to the agency in
July 2008. The agency has informed the Company that the response was a class 2 response, which
typically undergo a six month review. The letter does not affect current indications for Gardasil
in females aged nine through 26. 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 application
to support an indication for males nine 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 $134.5 million for the third quarter of 2008, a
decline of 21% compared with the third quarter of 2007. In the third quarter of 2007, the Company
recorded $51 million in revenue as a result of a government
purchase for the U.S. Centers for Disease Control and Prevention (CDC) stockpile.
Sales were $502.4 million for the first nine months of 2008, an increase of 34% compared with the
first nine months of 2007. The increase for the year-to-date period was driven largely by the
continued uptake in the United States and successful launches around the world. Sales in the first
nine months of 2008 included purchases of $54 million to support the CDC stockpile compared
with $51 million in the first nine months of 2007.
In October 2008, Merck announced that RotaTeq has been awarded pre-qualification status by the
World Health Organization (WHO). WHO pre-qualification allows for expanded access to RotaTeq and
provides a greater opportunity to help protect millions of babies from rotavirus gastroenteritis.
Because RotaTeq is pre-qualified by the WHO, the vaccine is eligible for procurement by the Pan
American Health Organization, UNICEF and other United Nations agencies for use in national
vaccination programs. RotaTeq is the only ready-to-use oral liquid rotavirus vaccine to receive
WHO pre-qualification. Merck has committed to providing RotaTeq to the Global
Alliance for Vaccines and Immunization-eligible countries at prices at which it
does not profit.
Also in October 2008, data on RotaTeq were presented at the 48th Interscience Conference on
Antimicrobial Agents and Chemotherapy / Infectious Diseases Society of America 46th Annual Meeting
in Washington, D.C. that showed RotaTeq reduced rotavirus-related hospitalizations and emergency
room visits combined by 100% during the 2007 and 2008 rotavirus seasons (January through May of
each year) in an observational study in the United States. The large, national, post-licensure
observational study was based on a review of health insurance claims data from approximately 61,000
infants in the United States.
Additionally, in October 2008, the CDC Advisory Committee on Immunization Practices (ACIP) voted
unanimously to recommend that adults ages 19 to 64 with asthma receive pneumococcal polysaccharide
vaccine (PPSV23), known as Pneumovax 23 (Pneumococcal Vaccine Polyvalent). Merck is the sole
supplier of Pneumovax 23 in the United States. The ACIP based this recommendation on study data
that showed an increased risk of pneumococcal disease among people with asthma. Pneumococcal
diseases are caused by common bacteria and can lead to potentially serious bacterial infections of
the lungs (pneumonia), lining of the brain (meningitis) and blood (bacteremia). The ACIP also voted
to recommend that people aged 19 through 64 years who smoke cigarettes should receive PPSV23 as
well as smoking-cessation counseling. This recommendation is the first time the ACIP has
recommended a vaccine specifically for people who smoke.
As previously disclosed, the Company has resolved an issue related to the bulk manufacturing
process for the Companys varicella zoster virus (VZV)-containing vaccines. The Company is
manufacturing bulk varicella and is producing doses of Varivax and Zostavax. The Company has
received regulatory approvals in the United States and certain other markets
- 33 -
to increase its
manufacturing capacity for VZV-containing vaccines. ProQuad, the Companys combination vaccine
that helps protect 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 $259.9
million for the first nine months of 2007.
Mercks sales of Varivax, the Companys vaccine for the prevention of chickenpox (varicella), were
$336.7 million for the third quarter of 2008 compared with $284.3 million for the third quarter of
2007 and were $710.6 million for the first nine months of 2008 compared with $585.1 million for the
first nine months 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 help protect against measles, mumps, and rubella, were $93.9 million for the third
quarter of 2008 compared with $75.3 million for the third quarter of 2007 and were $253.7 million
for the first nine months of 2008 compared with $173.1 million for the first nine months 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 in the third quarter of 2008 were comparable with sales for the third
quarter of 2007 and declined in the first nine months of 2008 compared with the corresponding period of
2007.
Sales of Zostavax, the Companys vaccine to help prevent shingles (herpes zoster), as recorded by
Merck were $11.2 million for the third quarter of 2008 as compared with $61.2 million in the third
quarter of 2007. Sales in the quarter were impacted by bulk vaccine supply issues that caused
delays in the fulfillment of customer orders. Merck expects to fill the customer back orders that
existed at the end of the third quarter by the end of 2008. Sales of Zostavax for the first nine
months of 2008 of $150.8 million were comparable with sales for same period a year ago. The
Company currently anticipates launching Zostavax outside the United States beyond 2009.
The Company has been working to resolve manufacturing issues related to its HIB-containing
vaccines, PedvaxHIB and Comvax since December 2007. The Company has resolved the original issue
related to equipment sterilization, but has identified another unrelated manufacturing process
change that will require a regulatory filing. Merck anticipates that PedvaxHIB and Comvax will
return to the U.S. market in mid-2009. Additionally, Merck anticipates the pediatric formulation
of Vaqta will be available in the fourth quarter of 2008 and the adult formulation in the first
quarter of 2009.
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 the 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 $107.3 million in the third quarter of 2008 and were $231.1 million for the first nine months
of 2008.
In October 2008, the Company presented results from a Phase III study that compared Mercks HIV
integrase inhibitor Isentress (raltegravir) to efavirenz (one of the leading antiretrovirals
prescribed for previously untreated (treatment-naïve)
HIV-infected patients. In the study, Isentress reduced HIV
viral load to undetectable levels in 86% of patients compared to 82% of patients treated with
efavirenz in previously untreated HIV patients at week 48. Both medicines were taken in
combination with tenofovir/emtricitabine. Patients taking Isentress had a greater increase in CD4
cell counts. In addition, drug-related adverse events of any severity occurred in fewer patients
treated with Isentress. The use of Isentress in treatment-naïve patients is investigational.
These 48 week findings were presented at the joint 48th Annual Interscience Conference on
Antimicrobial Agents and Chemotherapy / Infectious Diseases Society of America 46th Annual Meeting
in Washington, D.C.
Other Vaccines and Infectious Diseases segment products experiencing growth in the third quarter
and first nine months of 2008 compared with the same periods of 2007 include Invanz for the
treatment of selected moderate to severe infection in adults and Cancidas, an anti-fungal product.
In August 2008, Merck announced that the FDA approved an expanded label for Cancidas, which makes
it the first and only echinocandin therapy approved in the United States for the treatment of
pediatric patients aged three months to 17 years with indicated fungal infections.
Costs, Expenses and Other
In October 2008, the Company announced a global restructuring program (the 2008 Restructuring
Program) which represents the Companys efforts to reduce its cost structure, increase efficiency,
and enhance competitiveness. As part of the 2008 Restructuring Program, the Company expects to
eliminate approximately 7,200 positions 6,800 active
- 34 -
employees and 400 vacancies across all
areas of the Company worldwide by the end of 2011. About 40% of the total reductions will occur in
the United States. To streamline management layers across the Company, Merck will reduce its total
number of senior and mid-level executives by approximately 25%. For example, Merck will accelerate
the rollout of a new, more customer-centric selling model designed to provide Merck with a
meaningful competitive advantage and help physicians, patients and payers improve patient outcomes.
The Company also will make greater use of outside technology resources, centralize common sales
and marketing activities, and consolidate and streamline its operations. Mercks manufacturing
division will further focus its capabilities on core products and outsource non-core manufacturing.
In addition, Merck is enhancing its research operations to expand access to worldwide external
science and incorporate it as a key component of the Companys pipeline, and ensure a more
sustainable pipeline by translating basic research productivity into late-stage clinical success.
As a result, basic research operations will be organized to consolidate work in support of a given
therapeutic area into one of four locations. This will provide a more efficient use of research
facilities and result in the closure of three basic research sites in Tsukuba, Japan; Pomezia,
Italy; and Seattle by the end of 2009.
Separation costs are accounted for under FASB Statement No. 112, Employers Accounting for
Postemployment Benefits an amendment of FASB Statement No. 5 and 43 (FAS 112), and FASB
Statement No. 146, Accounting for Costs Associated with Exit or Disposal Activities (FAS 146).
In connection with the 2008 Restructuring Program, separation costs under the Companys existing
severance programs worldwide were accounted for under FAS 112 and recorded in the third quarter of
2008 to the extent such costs were estimable. The costs related to one-time termination benefits
offered to employees under the 2008 Restructuring Program will be accrued in the fourth quarter of
2008 as that is when the criteria necessary for accrual under FAS 146 will be met. The Company
recorded pretax restructuring costs of $720 million related to the 2008 Restructuring Program in
the third quarter of 2008 and anticipates that an additional $250 million to $450 million will be
recorded in the fourth quarter of 2008. The 2008 Restructuring Program is expected to be completed
by the end of 2011 with the total pretax costs estimated to be $1.6 billion to $2.0 billion. The
Company estimates that two-thirds of the cumulative pretax costs will result in future cash
outlays, primarily from employee separation expense. Approximately one-third of the cumulative
pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be
closed or divested. Merck expects the 2008 Restructuring Program to
yield cumulative pretax savings of $3.8 billion to $4.2 billion from
2008 to 2013.
In November 2005, the Company announced a global restructuring program (the 2005 Restructuring
Program) designed to reduce the Companys cost structure, increase efficiency, and enhance
competitiveness. As part of the 2005 Restructuring Program, Merck has sold or closed five
manufacturing sites and two preclinical sites and eliminated 10,400 positions company-wide as of
September 30, 2008. The Company also has sold and closed certain other facilities and related
assets in connection with the 2005 Restructuring Program. Since inception through September 30,
2008, the Company recorded total pretax accumulated costs of $2.5 billion associated with the 2005
Restructuring Program, which is substantially complete. The Company remains on track to achieving
cumulative pretax savings of $4.5 billion to $5.0 billion at the end of the 2005 2010 period.
The Company recorded total pretax restructuring costs of $847.3 million ($612.3 million after-tax)
and $178.1 million ($117.2 million after-tax) for the three months ended September 30, 2008 and
2007, respectively, related to both the 2008 and 2005 Restructuring Programs. The Company recorded
pretax restructuring costs of $1.05 billion ($745.7 million after-tax) and $536.4 million ($350.9
million after-tax) for the nine months ended September 30, 2008 and 2007, respectively. These
costs were comprised primarily of accelerated depreciation and separation costs recorded in
Materials and production, Research and development and Restructuring costs (see Note 2 to the
consolidated financial statements).
Materials and production costs were $1.48 billion for the third quarter of 2008, a decline of 3%
compared with the third quarter of 2007. Included in the third quarter of 2008 and 2007 were costs
associated with restructuring activities, primarily accelerated depreciation of $58.8 million and
$128.8 million, respectively. For the first nine months of 2008, materials and production costs
were $4.11 billion, a decline of 11% compared with the same period of last year. Included in the
first nine months of 2008 and 2007 were costs associated with restructuring activities of $89.8
million and $365.6 million, respectively. (See Note 2 to the consolidated financial statements).
Gross margin was 75.1% in the third quarter of 2008 compared with 75.0% in the third quarter of
2007, which reflect 1.0 and 2.1 percentage point unfavorable impacts, respectively, relating to
costs associated with restructuring activities. Gross margin was 76.9% for the first nine months
of 2008 compared with 74.4% for the first nine months of 2007, which reflect 0.5 and 2.0 percentage
point unfavorable impacts, respectively, relating to costs associated with restructuring
activities. Gross margins in the third quarter of 2008 as compared with 2007 reflect changes in
product mix and discards, primarily related to vaccines. Gross margins for the first nine months
of 2008 reflect changes in product mix and manufacturing efficiencies.
Marketing and administrative expenses were $1.73 billion for the third quarter of 2008, a decline
of 11% compared with the third quarter of 2007. For the first nine months of 2008, marketing and
administrative expenses were $5.51 billion, a
- 35 -
decrease of 6% compared with the first nine months of
2007. Expenses for the first nine months of 2008 include the impact of reserving an additional $40
million in the first quarter solely for future legal defense costs for Fosamax litigation.
Expenses for the third quarter and first nine months of 2007 include $70 million and $280 million,
respectively, of additional reserves solely for future legal defense costs for Vioxx litigation
(see Note 8 to the consolidated financial statements). In addition to lower expenses for future
legal defense costs, the declines in marketing and administrative expenses reflect the Companys
efforts to reduce its cost base.
Research and development expenses were $1.17 billion and $3.42 billion for the third quarter and
first nine months of 2008, respectively, compared with $1.44 billion and $3.50 billion for the
corresponding periods of 2007. Expenses in the
third quarter and first nine months of 2008 reflect $31.0 million of accelerated depreciation costs
related to the 2008 Restructuring Program. The third quarter and first nine months of 2007 reflect
$325.1 million of acquired research expense related to the NovaCardia Inc. acquisition. Research
and development expenses in 2008 compared with 2007 reflect an increase in development spending in
support of the continued advancement of the research pipeline.
In October 2008, Merck announced it will not seek regulatory approval for taranabant, an
investigational medicine, to treat obesity and is discontinuing its Phase III clinical development
program for taranabant for obesity. Available Phase III data showed that both efficacy and adverse
events were dose related, with greater efficacy and more adverse events in the higher doses.
Therefore, after careful consideration, the Company determined that the overall profile of
taranabant does not support further development for obesity.
In August 2008, Dynavax Technologies Corporation (Dynavax) and Merck announced top-line
immunogenicity results from a Phase III clinical trial comparing V270, an investigational hepatitis
B virus (HBV) vaccine, to a currently marketed HBV vaccine, Engerix-B (Engerix-B is a registered
trademark of GlaxoSmith Kline). V270 is being jointly developed by Dynavax and Merck for use in
adults and in patients with end stage renal disease. The study, called PHAST (Phase III HeplisAv
Short-regimen Trial), evaluated a two-dose regimen of V270 administered at 0 and 1 month compared
to a three-dose regimen of Engerix-B administered at 0, 1 and 6 months. The primary endpoint was
the proportion of subjects who developed protective antibodies to hepatitis B after
administration. The study achieved its primary endpoint. In PHAST, 95.1% of subjects who received
two doses of V270 developed protective antibodies to hepatitis B when measured at 12 weeks versus
81.1% of subjects who received three doses of Engerix-B when measured at 28 weeks. The
multi-center study evaluated 2,427 subjects from 11 to 55 years of age in Canada and Germany.
Results of additional analyses from this trial will be presented in the future.
In October 2008, Merck and Dynavax received communication from the FDA regarding the two companies
response to the agencys request for safety information relating to the clinical hold on the two
Investigational New Drug (IND) Applications for V270. In issuing the clinical hold in March
2008, the FDA requested a review of clinical and safety data including all available information
about a single case of Wegeners granulomatosis, an uncommon disease in which the blood vessels are
inflamed, reported in a Phase III clinical trial. Dynavax and Merck had previously provided a
response to the FDA in September 2008. In its October 2008 correspondence, the FDA advised the
companies that the balance of risk versus potential benefit no longer favors continued clinical
evaluation of V270 in healthy adults and children. The FDA has also advised the companies that
there may be potential for an acceptable risk versus benefit profile for V270 in patients with
renal failure, and requested additional information from the companies before considering further
pursuit of clinical studies in those patients. Dynavax and Merck are evaluating the FDAs response
in considering next steps. In the meantime, the clinical hold on the two U.S. IND applications for
V270 remains in effect.
In September 2008, at the 30th Annual Meeting of the American Society for Bone and
Mineral Research, two-year data from a Phase IIB study of odanacatib (formerly MK-0822), an
investigational, selective cathepsin K inhibitor in development for the treatment of osteoporosis,
were reported which demonstrated dose-dependent increases in bone mineral density (BMD) at the
total hip, lumbar spine and femoral neck fracture sites and decreased indices of bone resorption
compared to placebo in postmenopausal women with low BMD. Osteoporosis is a disease which reduces
bone density and strength and results in an increased risk of bone fractures. Odanacatib
selectively inhibits the cathepsin K enzyme believed to play a central role in osteoclastic bone
resorption, particularly in the degradation of the protein component of bone. Inhibition of
cathepsin K is a novel approach to the treatment of osteoporosis that differs from those of
currently approved treatments. The multi-center, double-blind, randomized, placebo-controlled
study evaluated doses of 3, 10, 25 or 50 mg of odanacatib administered orally, once-weekly and
without regard to the timing of meals or the patients physical position in postmenopausal women
with low BMD for 24 months. The number of patients experiencing a drug-related adverse experience
was similar between the 50 mg odanacatib group and placebo. The effect of odanacatib 50 mg on
vertebral, hip and non-vertebral fractures is currently being evaluated in a large, global Phase
III study.
- 36 -
Also, in September 2008, Merck announced that in a Phase III clinical trial telcagepant (formerly
known as MK-0974), an investigational oral calcitonin gene-related peptide (CGRP) receptor
antagonist, significantly relieved moderate-to-severe migraine attacks, including migraine pain and
migraine-associated symptoms, compared to placebo. The data were presented in London, England at
the European Headache/Migraine Trust International Congress. The reported findings are from a
worldwide, multicenter, randomized, placebo-controlled clinical trial in adult patients with acute
migraine. Telcagepant is a novel, oral CGRP receptor antagonist without direct vasoconstriction in
development for treatment of acute migraine. It is an antagonist of the receptor for CGRP, a
potent neuropeptide thought to play a central role in the underlying pathophysiology of migraine.
Merck continues to anticipate filing a New Drug Application (NDA) for telcagepant with the FDA in
2009.
In July 2008, the Company announced that Tredaptive (also known as MK-0524A) (extended-release
(ER) niacin/laropiprant) modified-release tablets, a new lipid-modifying therapy for patients
with dyslipidemia and primary
hypercholesterolemia, has been approved for marketing in the 27 countries of the EU, Iceland and
Norway. Tredaptive combines nicotinic acid (niacin) and laropiprant, a novel flushing pathway
inhibitor. In clinical studies involving more than 4,700 patients, Tredaptive reduced
LDL-cholesterol (LDL-C, or bad cholesterol) levels, raised HDL-cholesterol (HDL-C, or good
cholesterol) levels and decreased triglycerides (a type of fat in the blood). High LDL-C, low
HDL-C and elevated triglycerides are risk factors associated with heart attacks and strokes.
Tredaptive is approved for the treatment of dyslipidemia, particularly in patients with combined
mixed dyslipidemia (characterized by elevated levels of LDL-C and triglycerides and low HDL-C) and
in patients with primary hypercholesterolemia (heterozygous familial and non-familial). Tredaptive
should be used in patients in combination with statins, when the cholesterol lowering effects of
statin monotherapy is inadequate. Tredaptive can be used as monotherapy only in patients in whom
statins are considered inappropriate or not tolerated. The launch of Tredaptive in Europe and
other markets will be delayed due to a manufacturing-related issue. Merck is committed to quickly
resolving the issue and to making Tredaptive available in Europe as soon as possible.
In June 2008, Merck provided an update on the regulatory status in the United States of its
investigational medicines MK-0524A and MK-0524B (ER niacin/laropiprant/simvastatin) for the
treatment of primary hypercholesterolemia or mixed dyslipidemia. Merck met with the FDA to discuss
the non-approvable action letter it received on April 28, 2008 in response to its NDA for MK-0524A.
At the meeting, the FDA stated that additional efficacy and safety data were required and
suggested that the Company wait for the results of the HPS2-THRIVE (Treatment of HDL to Reduce the
Incidence of Vascular Events) cardiovascular outcomes study, which is expected to be completed in
January 2013. The Company intends to continue to discuss with the FDA whether data can be provided
prior to the completion of the HPS2-THRIVE study that would address the issues raised by the agency
and allow for an earlier filing. In that event, the earliest Merck would file a complete response
to the FDA action letter would be 2010. In October 2008, Oxford University issued a press release
announcing that it expects to enroll an additional 5,000 patients in the HPS2-THRIVE study to
increase the total study population size to 25,000 patients. The study was initially expected to
be complete in 2013; the addition of the 5,000 patients may allow the study to be completed
earlier. In addition, Merck will not seek approval for MK-0524B in the United States until it
files its complete response relating to MK-0524A. The clinical development program for MK-0524A
continues, including the HPS2-THRIVE study. Also, in the FDAs April 2008 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. In other
countries around the world, Merck continues to pursue regulatory approvals for MK-0524A.
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.
In September 2008, Merck and Japan Tobacco Inc. (JT) signed a worldwide licensing agreement to
develop and commercialize JTT-305, an investigational oral osteoanabolic (bone growth stimulating)
agent for the treatment of osteoporosis. JTT-305 is an investigational oral calcium sensing
receptor antagonist that is currently being evaluated by JT in Phase II clinical trials in Japan
for its effect on increasing bone density and is in Phase I clinical trials outside of Japan.
Under the terms of the agreement, Merck gains worldwide rights, except for Japan, to develop and
commercialize JTT-305 and certain other related compounds.
JT will receive an
upfront payment of $85 million, which the Company will record as Research and development expense
upon closing in the fourth quarter of 2008,
and is
eligible to receive additional cash payments upon achievement of certain milestones associated with
the development and approval of a drug candidate covered by this agreement. JT will also be
eligible to receive royalties from sales of any drug candidates that receive marketing approval.
Restructuring costs, primarily representing separation and other related costs associated with the
2008 and 2005 Restructuring Programs, were $757.5 million and $929.4 million for the three and nine
months ended September 30,
- 37 -
2008. The Company recorded $655.1 million of costs associated with the
2008 Restructuring Program for the three and nine months ended September 30, 2008. The remaining
restructuring costs were associated with the 2005 Restructuring Program. Amounts for the first
nine months of 2008 were reduced by gains on sales of facilities and related assets of $54.4
million. (See Note 2 to the consolidated financial statements.) Amounts included in Restructuring
costs for the three and nine months ended September 30, 2007 were $49.3 million and $170.9 million,
respectively.
Equity income from affiliates, which reflects the performance of the Companys joint ventures and
other equity method affiliates, was $665.6 million and $768.5 million for the third quarter of 2008
and 2007, respectively, and was $1.84 billion and $2.18 billion for the first nine months of 2008
and 2007, respectively. These results reflect lower partnership returns from AZLP and decreased
equity income from the Merck/Schering-Plough partnership, partially offset by higher equity income
from SPMSD. The lower partnership returns from AZLP are primarily attributable to the first
quarter 2008 partial redemption of Mercks limited partnership interest in AZLP, which resulted in
a reduction of the priority return and the variable returns which were based, in part, upon sales
of certain former Astra USA, Inc. products. The decrease in equity income from the
Merck/Schering-Plough joint venture is a result of lower revenues of Zetia and Vytorin related to
the ENHANCE and SEAS clinical trial results. In addition, as a result of the termination of the
respiratory joint venture, the Company was obligated to Schering-Plough Corporation
(Schering-Plough) in the amount of $105 million as specified in the joint venture agreements.
This resulted in a charge of $43 million during the second quarter of 2008, included in Equity
income from affiliates. The remaining amount will be amortized over the remaining patent life of
Zetia through 2016. The increase in equity income from SPMSD is largely attributable to higher
sales of Gardasil. (See Note 6 to the consolidated financial statements and Selected Joint
Venture and Affiliate Information below.)
Other (income) expense, net in the first nine months of 2008 primarily reflects an aggregate gain
from AZLP of $2.2 billion (see Note 6 to the consolidated financial statements) 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, recognized
losses of $108 million, including $88 million of losses in the third quarter, in the Companys
investment portfolio and a $58 million charge related to the resolution of a previously disclosed
investigation into whether the Company violated state consumer protection laws with respect to the
sales and marketing of Vioxx (see Note 8 to the consolidated financial statements). Other (income)
expense, net in the first nine months of 2007 primarily reflects the favorable impact of gains on
sales of assets and product divestitures, as well as a net gain on the settlements of certain
patent disputes.
Segment Profits
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
($ in millions) |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
Pharmaceutical segment |
|
$ |
3,165.5 |
|
|
$ |
3,305.1 |
|
|
$ |
9,397.5 |
|
|
$ |
9,977.6 |
|
Vaccines and Infectious Diseases segment |
|
|
772.7 |
|
|
|
815.7 |
|
|
|
2,042.9 |
|
|
|
1,941.1 |
|
Other segment |
|
|
98.6 |
|
|
|
112.9 |
|
|
|
363.9 |
|
|
|
395.5 |
|
Other |
|
|
(2,625.9 |
) |
|
|
(2,169.1 |
) |
|
|
(3,923.9 |
) |
|
|
(5,763.0 |
) |
|
Income before income taxes |
|
$ |
1,410.9 |
|
|
$ |
2,064.6 |
|
|
$ |
7,880.4 |
|
|
$ |
6,551.2 |
|
|
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 third quarter of 2008 and declined 6% for the
first nine months of 2008 compared with the corresponding periods of 2007 largely driven by
declines in Fosamax, Nexium supply sales, Zocor and lower equity income from AZLP and the
Merck/Schering-Plough joint venture.
- 38 -
Vaccines and Infectious Diseases segment profits decreased 5% in the third quarter of 2008 compared
with the third quarter of 2007, largely driven by lower sales of
Zostavax, RotaTeq and hepatitis
vaccines. Vaccines and infectious diseases segment profits increased 5% in the first nine months
of 2008 compared with the same period of 2007 primarily driven by the successful launch of
Isentress and the strong performance of RotaTeq, as well as higher equity income from SPMSD.
The effective tax rate of 22.6% for the third quarter of 2008 reflects the favorable impact of
restructuring charges. The effective tax rate of 21.8% for the first nine months of 2008 reflects
a net favorable impact of approximately 2 percentage points which includes favorable impacts
relating to second quarter tax settlements that resulted in a reduction of the Companys liability
for unrecognized tax benefits of approximately $200 million, the first quarter realization of
foreign tax credits and year-to-date restructuring costs, largely offset by an unfavorable impact
resulting from the AZLP gain being fully taxable in the United States at a combined federal and
state tax rate of approximately 36.3%. 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 first quarter based on a change in the
Companys repatriation plans. The effective tax rates of 26.1% for the third quarter of 2007 and
25.1% for the first nine months of 2007 reflect the impact of acquired research expense which is
not deductible for tax purposes, as well as the favorable impact of restructuring costs.
Net income was $1.09 billion for the third quarter of 2008 compared with $1.53 billion for the
third quarter of 2007 and was $6.16 billion for the first nine months of 2008 compared with $4.91
billion for the first nine months of 2007. Earnings per common share assuming dilution (EPS) for
the third quarter of 2008 were $0.51 compared with $0.70 in the third quarter of 2007 and were
$2.86 for the first nine months of 2008 compared with $2.24 in the first nine months of 2007. The
decrease in net income and EPS for the third quarter of 2008 was largely attributable to higher
restructuring charges and increased expenses within other (income) expense, net, partially offset
by a decline in acquired research expense and marketing and administrative expenses. For the first
nine months of 2008, the increases are primarily attributable to the impact of the gain on
distribution from AZLP as discussed above. In addition, the increases reflect the positive impact
of tax settlements and the realization of foreign tax credits, lower acquired research costs and a
lower reserve for legal defense costs, partially offset by higher restructuring costs and a decline
in equity income from affiliates.
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 $1.1 billion for the third quarter of 2008, representing a decline of 15% over
the third quarter of 2007, and a sequential decline of 4% compared with the second quarter of 2008.
Sales for the first nine months of 2008 were $3.49 billion, a decline of 7% over the first nine
months of 2007. Global sales of Zetia, the cholesterol-absorption inhibitor also marketed as
Ezetrol outside the United States, were $534.3 million in the third quarter of 2008, a decline of
12% compared with the third quarter of 2007, and a sequential decline of 5% compared with the
second quarter of 2008. Global sales of Zetia for the first nine months of 2008 were $1.68
billion, a decrease of 3% compared with the same period of 2007. Global sales of Vytorin, marketed
outside the United States as Inegy, were $567.2 million in the third quarter of 2008, a decline of
18% compared with the third quarter of 2007, and a sequential decline of 4% compared with the
second quarter of 2008. Global sales of Vytorin for the first nine months of 2008 were $1.81
billion, a decline of 10% compared with the same period of 2007. Sales declines in the United
States were partially offset by growth outside the United States.
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
- 39 -
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.
On July 21, 2008, efficacy and safety results from the Simvastatin and Ezetimibe in Aortic Stenosis
(SEAS) study were announced. SEAS was designed to evaluate whether intensive lipid lowering with
Vytorin (ezetimibe/simvastatin) 10/40 mg would reduce the need for aortic valve replacement and the
risk of cardiovascular morbidity and mortality versus placebo in patients with asymptomatic mild to
moderate aortic stenosis who had no indication for statin therapy. Vytorin failed to meet its
primary end point for the reduction of major cardiovascular events. There also was no significant
difference in the key secondary end point of aortic valve events; however, there was a reduction in
the group of patients taking Vytorin compared to placebo in the key secondary end point of ischemic
cardiovascular events. Vytorin is not indicated for the treatment of aortic stenosis. Vytorin
contains two active ingredients: ezetimibe and simvastatin. No incremental benefit of Vytorin on
cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been
established. In the study, patients in the group who took Vytorin 10/40 mg had a higher incidence
of cancer than the group who took placebo. There was also a nonsignificant increase in deaths from
cancer in patients in the group who took Vytorin versus those who took placebo. Cancer and cancer
deaths were distributed across all major organ systems. The Company believes the cancer finding in
SEAS is likely to be an anomaly that, taken in light of all the
available data, does not support an association with Vytorin. The Company, through the MSP
Partnership, is committed to working with regulatory agencies to further evaluate the available
data and interpretations of those data; however, the Company does not believe that changes in the
clinical use of Vytorin are warranted.
See Note 8 to the consolidated financial statements for information with respect to litigation
involving Merck and Schering-Plough (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 non-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. In June 2008, the Partners announced the withdrawal of the NDA for the
loratadine/montelukast combination tablet. The companies also terminated the respiratory joint
venture. This action had no impact on the business of the cholesterol joint venture. As a result
of the termination of the respiratory joint venture, the Company was obligated to Schering-Plough
in the amount of $105 million as specified in the joint venture agreements. This resulted in a
charge of $43 million during the second quarter of 2008, included in Equity income from affiliates.
The remaining amount is being amortized over the remaining patent life of Zetia through 2016.
AstraZeneca LP
As previously disclosed, the 1999 AstraZeneca merger triggered a partial redemption in March 2008
of Mercks limited partnership interest in 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 in the first quarter of 2008. 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.
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 Inc.
(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
- 40 -
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 were $566.8 million and $439.3 million in the third quarter
of 2008 and 2007, respectively, and were $1.41 billion and $898.9 million for the first nine months
of 2008 and 2007, respectively. The increase in both periods was driven by higher sales of
Gardasil. SPMSD sales of Gardasil were $220.1 million and $137.0 million for the third quarter of
2008 and 2007, respectively, and were $694.1 million and $245.0 million for the first nine months
of 2008 and 2007, respectively.
The Company records the results from its interest in the MSP Partnership, AZLP and SPMSD in Equity
income from affiliates.
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
($ in millions) |
|
2008 |
|
2007 |
|
Cash and investments |
|
$ |
13,053.0 |
|
|
$ |
15,390.0 |
|
Working capital |
|
$ |
4,990.3 |
|
|
$ |
2,787.2 |
|
Total debt to total liabilities and equity |
|
|
14.3 |
% |
|
|
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 nine months of 2008, cash provided by operating activities of $5.6 billion
reflects $2.1 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 nine
months 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 and a $500 million payment into a Vioxx settlement
fund. Cash provided by operating activities of $4.7 billion for the same period of 2007 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 used by investing activities in
the first nine months of 2008 was $1.4 billion compared with $2.0 billion in the first nine months
of 2007. The lower use of cash by investing activities primarily reflects a distribution from AZLP
in 2008 representing a return of the Companys investment in AZLP and a $1.1 billion payment in
2007 in connection with the December 2006 acquisition of Sirna Therapeutics, Inc., partially offset
by higher purchases of securities and other investments and an increase in restricted assets. Cash
used in financing activities was $3.8 billion for the first nine months of 2008 compared with $3.5
billion in the first nine months of 2007 reflecting higher purchases of treasury stock and lower
proceeds from the exercise stock options, partially offset by a net increase in short-term
borrowings.
In August 2008, the Company executed a $4.1 billion letter of credit agreement with a financial
institution, which satisfied certain conditions set forth in the U.S. Vioxx Settlement Agreement
(see Note 8 to the consolidated financial statements). The Company pledged collateral to the
financial institution of approximately $5.1 billion pursuant to the terms of the letter of credit
agreement. Although the amount of assets pledged as collateral is set by the letter of credit
agreement and such assets are held in custody by a third party, the assets are managed by the
Company. The Company considers the assets pledged under the letter of credit agreement to be
restricted. As a result, $2.1 billion and $1.4 billion of cash and investments, respectively, were
classified as restricted current assets and $1.6 billion of investments were classified as
restricted non-current assets. The letter of credit amount and required collateral balances will
decline as payments (after the first $750 million) under the Settlement Agreement are made. As of
September 30, 2008, $3.7 billion was recorded within Deferred income taxes and other current assets
and $1.4 billion was classified as Other assets.
In addition, in August 2008, the Company deposited $500 million into a Vioxx settlement fund. In
October 2008, the Company made an additional payment into the settlement fund of $250 million
pursuant to the Settlement Agreement. The Company will not make any additional payments into the
settlement fund in 2008.
- 41 -
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 $1.5 billion (U.S.
dollars) plus interest of approximately $1.0 billion (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 $21 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 $1.3 billion at September 30, 2008. During the first nine months of
2008, approximately $400 million of cash and cash equivalents in the collateral account was
transferred out and a corresponding amount of investments was transferred in. 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 $914.3 million and $726.3 million for the first nine months of 2008
and 2007, respectively. Capital expenditures for full year 2008 are estimated to be $1.4 billion.
Dividends paid to stockholders were $2.5 billion for the first nine months of both 2008 and 2007.
In May and July 2008, the Board of Directors declared a quarterly dividend of $0.38 per share on
the Companys common stock for the third and fourth quarters of 2008.
The Company purchased $2.5 billion of its common stock (62.3 million shares) for its Treasury
during the first nine months of 2008. The Company has approximately $2.6 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.
Financial Instruments and Market Risk Disclosure
To manage foreign currency risks of future cash flows derived from foreign currency denominated
sales, the Company has an established revenue hedging risk management program in which the Company
primarily uses purchased local currency put options to layer in hedges over time to partially hedge
anticipated third-party sales. During 2008, on a limited basis, the Company also utilized collars
and forward exchange contracts in its revenue hedge risk management program.
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 4 to the
consolidated financial statements), there have been no significant changes in the Companys
critical accounting policies since December 31, 2007.
- 42 -
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 4 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. As of September 30, 2008, $183.7 million of the investment securities associated with the
redemption-in-kind remained classified in Level 3 (approximately 1.7% 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 12 to the consolidated
financial statements)). These securities were valued primarily using pricing models for which
management understands the methodologies. These models incorporate transaction details such as
contractual terms, maturity, timing and amount of future cash inflows, as well as assumptions about
liquidity and credit valuation adjustments of marketplace participants at September 30, 2008.
Recently Issued Accounting Standards
In October 2008, the Financial Accounting Standards Board (FASB) issued Staff Position 157-3,
Determining the Fair Value of a Financial Asset When the Market for That Asset Is Not Active (FSP
157-3), which clarifies the application of FAS 157 in a market that is not active. FSP 157-3 was
effective for the Company at September 30, 2008, and the effect of adoption on the Companys
financial position and results of operations was not material.
In June 2008, the FASB issued Staff Position EITF 03-6-1, Determining Whether Instruments Granted
in Share-Based Payment Transactions Are Participating Securities (FSP EITF 03-6-1), which is
effective January 1, 2009. FSP EITF 03-6-1 clarifies that share-based payment awards that entitle
holders to receive nonforfeitable dividends before they vest will be considered participating
securities and included in the basic earnings per share calculation. The Company is assessing the
impact of adoption of FSP EITF 03-6-1 on its results of operations.
In May 2008, the FASB issued Statement No. 162, The Hierarchy of Generally Accepted Accounting
Principles (FAS 162), which is effective in the fourth quarter of 2008. FAS 162 identifies the
sources of accounting principles and the framework for selecting the principles used (order of
authority) in the preparation of financial statements that are presented in conformity with
generally accepted accounting standards in the United States. The Company does not expect the
adoption of FAS 162 to have a material impact on its financial statements.
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 Emerging Issues Task Force
(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
- 43 -
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 Statement No. 141R, Business Combinations (FAS 141R), and
Statement 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 provides guidance for the accounting,
reporting and disclosure of noncontrolling interests and 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 (i) this report, (ii) the Companys Reports on Form
10-Q for the quarters ended March 31, 2008 and June 30, 2008 and (iii) the Companys Annual Report
on Form 10-K for the year ended December 31, 2007.
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
September 30, 2008, the Company had been served or was aware that it had been named as a defendant
in approximately 11,575 lawsuits, which include approximately 29,200 plaintiff groups, alleging
personal injuries resulting from the use of Vioxx, and in approximately 246 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 9,000 lawsuits representing approximately 23,400 plaintiff groups are or are slated
to be in the federal MDL and approximately 725 lawsuits representing approximately 725 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 25,100
plaintiffs had been dismissed as of September 30, 2008. Of these, there have been over 3,650
plaintiffs whose claims were dismissed with prejudice (i.e., they cannot be brought again) either
by plaintiffs themselves or by the courts. Over 21,450 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, approximately 13,575 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.
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 Plaintiffs Steering
Committee (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
myocardial infarction (MI) and ischemic stroke (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%
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. Merck will pay a fixed aggregate amount of
$4.85 billion into two funds ($4.0 billion for MI claims and $850 million for IS claims) for
qualifying claims that enter into the
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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
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. The Settlement
Agreement provided that Mercks payment obligations would 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% of their clients who
allege either MI or IS and (2) by June 30, 2008, plaintiffs enroll in the Settlement Program at
least 85% 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. Under the terms of the Settlement Agreement, Merck could
exercise a right to walk away from the Settlement Agreement if the thresholds and other
requirements were not met. The Company waived that right as of August 4, 2008. The waiver of that
right triggered Mercks obligation to pay a fixed total of $4.85 billion. Payments will be made in
installments into the settlement fund. The first payment of $500 million was made in August 2008
and an additional payment of $250 million was made in October 2008. Additional payments will be
made on a periodic basis going forward, when and as needed to fund payments of claims and
administrative expenses.
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. The
distribution of interim payments to qualified claimants began in August 2008 and will continue on a
rolling basis until all claimants who qualify for an interim payment are paid. Final payments will
be made after the examination of all of the eligible claims has been completed.
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) required plaintiffs with cases pending as of November 9, 2007
to preserve and produce records and serve expert reports; and (4) required 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 October 30, 2008, the last day for enrollment in the Settlement Program, more than 48,100 of the approximately 48,325 individuals who were eligible for the Settlement Program and whose claims are not 1) dismissed, 2) expected to be dismissed in the near future, or 3) tolled claims that appear to have been abandoned have submitted some or all of the materials required
for enrollment in the Settlement 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 99% of the eligible MI and IS claims previously registered with the Settlement Program.
On April 14, 2008 and June 3, 2008, two groups of various private insurance companies and health
plans filed suit against BrownGreer, the claims administrator for the Settlement Program (the Claims Administrator), and U.S. Bancorp, escrow agent for the Settlement Program (the
AvMed and Greater New York Benefit Fund suits). 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. Each group sought temporary restraining orders and
preliminary injunctions. Judge Fallon denied these requests. In AvMed, the defendants moved to
sever the claims of the named plaintiffs and, in Greater New York Benefit Fund, to strike the class
allegations. Judge Fallon granted these motions. AvMed has appealed both of these decisions. The
Fifth Circuit will hear argument on AvMeds appeal on November 4, 2008. Greater New York Benefit
Fund has served a notice of appeal.
The Company maintains a list of Vioxx Product Liability Lawsuits scheduled for trial 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
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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 third 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 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 March 20, 2008, plaintiffs moved to dismiss their appeal, seeking instead to vacate the
trial courts decision. Merck filed an opposition to plaintiffs motion. On May 15, 2008, the
Court of Appeals issued an order granting plaintiffs motion to dismiss the appeal, but denying
plaintiffs motion to vacate the order dismissing the claim. On July 25, 2008, the appeal was
dismissed by agreement of the parties.
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 appealed the judgments in both cases and the
Appellate Division held oral argument on both cases on January 16, 2008. On May 29, 2008, the New
Jersey Appellate Division vacated the consumer fraud awards in both cases on the grounds that the
Product Liability Act provides the sole remedy for personal injury claims. The Appellate Division
also vacated the McDarby punitive damage award on the grounds that it is preempted and vacated the
attorneys fees and costs awarded under the Consumer Fraud Act in both cases. The Court upheld the
McDarby compensatory award. The Company has filed with the Supreme Court of New Jersey a petition
to appeal those parts of the trial courts rulings that the Appellate Division affirmed.
Plaintiffs filed a cross-petition to appeal those parts of the trial courts rulings that the
Appellate Division reversed. Those petitions are currently pending.
On October 8, 2008, the Supreme Court of New Jersey granted
Mercks petition for certification of appeal, limited solely to
the issue of whether the Federal Food, Drug and Cosmetic Act preempts
state law tort claims predicated on the alleged inadequacy of
warnings contained in Vioxx labeling that was approved by the
FDA. The court denied the plaintiffs cross-petition.
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. On May 29, 2008,
the Texas Court of Appeals reversed the trial courts judgment and issued a judgment in favor of
Merck. The Court of Appeals found the evidence to be legally insufficient on the issue of
causation. Plaintiffs have filed a motion for rehearing en banc in the Court of Appeals. Merck
filed a response in October 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 even though under Texas law, in this case, potential
punitive damages were capped at $750,000. On May 14, 2008, the San Antonio Court of Appeals
reversed the judgment and rendered a judgment in favor of Merck. On May 29, 2008, plaintiffs filed
a motion for rehearing, which is currently pending.
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
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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.
At the parties request, Judge Higbee has extended the briefing schedule in Martin-Kleinman v.
Merck, which is a putative consumer class action pending in New Jersey Superior Court. The Court
will set a new schedule after resolving certain discovery issues.
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. The majority of these cases are at early procedural
stages. On June 12, 2008, a Missouri state court certified a class of Missouri plaintiffs seeking
reimbursement for out-of-pocket costs relating to Vioxx. The plaintiffs do not allege any personal
injuries from taking Vioxx. The Company filed a petition for interlocutory review on June 23,
2008, which was granted on July 30, 2008. During the pendency of the appeal, discovery is
proceeding in the lower court.
Plaintiffs also have filed a class action in California state court seeking class certification of
California third-party payors and end-users. The parties are engaged in class certification
discovery and briefing.
As previously reported, the Company has also been named as a defendant in separate lawsuits brought
by the Attorneys General of nine 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 six other lawsuits containing similar allegations filed
by (or on behalf of) governmental entities seeking the reimbursement of alleged Medicaid
expenditures for Vioxx or statutory penalties tied to such expenditures. Those lawsuits are (1) a
class action filed by Santa Clara County, California on behalf of all similarly situated California
counties, (2) separate actions filed by Erie County, Chautauqua County, and Orange County, New
York, (3) a qui tam action brought by a resident of the District of Columbia, and (4) a qui tam
action brought by a resident of Florida. With the exception of a case filed by the Texas Attorney
General (which remains in Texas state court and is currently scheduled for trial in September
2009), a case recently filed by the Michigan Attorney General (which has been removed to federal
court and will likely be transferred to the federal MDL shortly) and the recently-filed Orange
County and Florida cases (which will be removed to federal court and will likely be transferred to
the federal MDL), the rest of the actions described in this paragraph have been transferred to the
federal MDL and are in the discovery phase.
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 appealed Judge Cheslers
decision to the United States Court of Appeals for the Third Circuit. On September 9, 2008, the
Third Circuit issued an opinion reversing Judge Cheslers order and remanding the case to the
district court. On September 23, 2008, Merck filed a petition seeking rehearing en banc which was
denied.
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
- 47 -
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.
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. The Court denied
the motion in June 2008 and closed the case. Plaintiffs have appealed Judge Cheslers decision to
the United States Court of Appeals for the Third Circuit.
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 October 6, 2008 defendants filed a motion
for judgment on the pleadings seeking dismissal of the complaint.
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. The current and former executive and director defendants filed
motions to dismiss the complaint in June 2008. Those motions are pending.
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, The Philippines, Turkey, and
Israel.
On May 30, 2008, the provincial court of Queens Bench in Saskatchewan, Canada entered an order
certifying a class of Vioxx users in Canada, except those in Quebec. The class includes individual
purchasers who allege inducement to purchase by unfair marketing practices; individuals who allege
Vioxx was not of acceptable quality, defective or not fit for the purpose of managing pain
associated with approved indications; or ingestors who claim Vioxx caused or exacerbated a
cardiovascular or gastrointestinal condition. On June 17, 2008, the Court of Appeal for
Saskatchewan granted the Company leave to appeal the certification order and the appeal is pending
before that court. On July 28, 2008, the Superior court in Ontario decided to certify an
overlapping class of Vioxx users in Canada, except those in Quebec and Saskatchewan, who allege
negligence and an entitlement to elect to waive the tort. The Companys motion for leave to
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appeal
that decision is pending before the Ontario Divisional Court. Earlier, in November 2006, the
Superior court in Quebec authorized the institution of a class action on behalf of all individuals
who, in Québec, consumed Vioxx and suffered damages arising out of its ingestion. As of
September 30, 2008, the plaintiffs have not instituted an action based upon that authorization.
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. Through an
arbitration proceeding and negotiated settlements, the Company received an aggregate of
approximately $590 million in product liability insurance proceeds relating to the Vioxx Product
Liability Lawsuits, plus approximately $45 million in fees and interest payments. The Company has
no additional insurance for 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.
The Company also 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 proceeding 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
Securities and Exchange Commission (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, on May 20, 2008, the Company reached civil settlements with Attorneys
General from 29 states and the District of Columbia to fully resolve previously disclosed
investigations under state consumer protection laws related to past activities for Vioxx. As part
of the civil resolution of these investigations, Merck paid a total of $58 million to be divided
among the 29 states and the District of Columbia. In April 2008, Merck announced it had taken a
pretax charge in the first quarter of $55 million in anticipation of this settlement. The
agreement also includes compliance measures that supplement policies and procedures previously
established by the Company.
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%
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
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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 Vioxx Product Liability Lawsuits will be tried in the
future. 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 half of 2008, the Company spent
approximately $156 million in the aggregate in legal defense costs related to the Vioxx Litigation.
In the third quarter of 2008, the Company spent approximately $66 million in the aggregate in
legal defense costs related to the Vioxx Litigation. In
addition, in the third quarter the Company paid $500 million
into the settlement fund in connection with the Settlement Agreement referred to above. Thus, as
of September 30, 2008, the Company had a reserve of approximately $4.649 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, 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 trials, which may occur in 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.
The Company 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 September 30, 2008, approximately 700
cases, which include approximately 1,143 plaintiff groups had been filed and were pending against
Merck in either federal or state court, including two 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 583 of the cases are before Judge Keenan.
Judge Keenan issued a Case Management Order (and various amendments thereto) 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
October 1, 2008. Briefing and argument on plaintiffs motions for certification of medical
monitoring classes were completed in 2007 and Judge Keenan issued an order denying the motions on
January 3, 2008. 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. In
October 2008, Judge Keenan issued an order requiring that Daubert motions be filed in May 2009 and
scheduling trials in the first three cases in the MDL for August 2009, October 2009, and January
2010, respectively.
- 50 -
In addition, in July 2008, an application was made by the Atlantic County Superior Court of New
Jersey requesting that all of the Fosamax cases pending in New Jersey be considered for mass tort
designation and centralized management before one judge in New Jersey. On October 6, 2008, the New
Jersey Supreme Court ordered that all pending and future actions filed in New Jersey arising out of
the use of Fosamax and seeking damages for existing dental and jaw-related injuries, including
osteonecrosis of the jaw, but not solely seeking medical monitoring, be designated as a mass tort
for centralized management purposes before Judge Carol Higbee in Atlantic County Superior
Court. Judge Higbee has scheduled an initial case management conference in the New Jersey matters
for November 14, 2008.
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 half of 2008, the
Company spent approximately $17 million and added $40 million to its reserve. In the third
quarter, the Company spent approximately $8 million. Consequently, as of
September 30, 2008, the Company had a reserve of approximately $42 million. Some of the
significant factors considered in the establishment and ongoing assessment of the reserve for the
Fosamax Litigation legal defense costs 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 the completion of the first three federal trials discussed above. 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.
Vytorin/Zetia 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 (O&I), 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. In addition,
on August 21 and September 2, 2008, respectively, the companies received additional letters from
O&I seeking certain information and documents related to the SEAS clinical trial. As previously
disclosed, the companies have each received subpoenas from the New York and New Jersey State
Attorneys General Offices and a letter from the Connecticut Attorney General seeking similar
information and documents. In addition, the Company has received five Civil Investigative Demands
(CIDs) from a multistate group of 35 State Attorneys General who are jointly investigating
whether the companies violated state consumer protection laws when marketing Vytorin. Finally, on
September 10, 2008, the Company received a letter from the Civil Division of the U.S. Department of
Justice informing it that the DOJ is investigating whether the companies conduct relating to the
promotion of Vytorin caused false claims to be submitted to federal health care programs. 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 140 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.
This suit has since been withdrawn and re-filed in
the District of New Jersey and has been consolidated with another
federal securities lawsuit under the caption In re Merck &
Co., Inc. Vytorin Securities Litigation. An amended consolidated
complaint was filed on October 6, 2008 and names as defendants
Merck; Merck/Schering-Plough Pharmaceuticals, LLC; and certain of the
Companys officers and directors.
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.
Since that time, there have been other similar ERISA
lawsuits filed against the Company in the District of New Jersey, and
all of those lawsuits have been consolidated under the caption In
re Merck & Co., Inc. Vytorin ERISA Litigation.
Plaintiffs in these suits allege 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.
- 51 -
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file Abbreviated New Drug
Applications (ANDAs) with the FDA seeking to market generic forms of the Companys products
prior to the expiration of relevant patents owned by the Company. Generic pharmaceutical
manufacturers have submitted ANDAs to the FDA seeking to market in the United States a generic
form of Propecia, Prilosec, Nexium, Singulair 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 finasteride (Propecia),
montelukast (Singulair), 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.
As previously disclosed, in February 2007, the Company received a notice from Teva Pharmaceuticals
(Teva), a generic company, indicating that it had filed an ANDA for montelukast and that it is
challenging the U.S. patent that is listed for Singulair. On April 2, 2007, the Company filed a
patent infringement action against Teva. The lawsuit automatically stays FDA approval of Tevas
ANDA for 30 months or until an adverse court decision, if any, whichever may occur earlier. A
trial in this matter has been scheduled to begin on February 23, 2009.
Other Litigation
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.
- 52 -
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.
As the Company has previously disclosed, it is proceeding with a multi-year implementation of an
enterprise wide resource planning system. During October 2008, the Company implemented this system
at certain North American sites which included modifications to the design, operation and
documentation of its internal controls over financial reporting. The Company also continues to
transition certain financial functions into regionalized shared service environments, at certain of
the Companys locations.
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.
- 53 -
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 September 30, 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) |
July 1 - July 31, 2008 |
|
|
8,647,445 |
|
|
$ |
33.07 |
|
|
$ |
3,260.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 1 - August 31, 2008 |
|
|
10,743,405 |
|
|
$ |
35.03 |
|
|
$ |
2,884.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 1 - September 30, 2008 |
|
|
9,241,000 |
|
|
$ |
32.67 |
|
|
$ |
2,582.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
28,631,850 |
|
|
$ |
33.68 |
|
|
$ |
2,582.3 |
|
|
|
|
(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 |
|
|
|
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 |
- 54 -
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: November 3, 2008
|
|
/s/ Bruce N. Kuhlik |
|
|
|
|
|
|
|
|
|
BRUCE N. KUHLIK |
|
|
|
|
Executive Vice President and General Counsel
|
|
|
|
|
|
|
|
Date: November 3, 2008
|
|
/s/ John Canan |
|
|
|
|
|
|
|
|
|
JOHN CANAN |
|
|
|
|
Senior Vice President and Controller |
|
|
- 55 -
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 |
|
|
|
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 |
- 56 -