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, 2006
OR
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o |
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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.
P. O. Box 100
One Merck Drive
Whitehouse Station, N.J. 08889-0100
(908) 423-1000
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Incorporated in New Jersey
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I.R.S. Employer Identification
No. 22-1109110 |
The number of shares of common stock outstanding as of the close of business on October 31, 2006:
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Class
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Number of Shares Outstanding |
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Common Stock
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2,171,002,669 |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports) and (2) has been subject
to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer þ Accelerated filer o Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
TABLE OF CONTENTS
Part I Financial Information
Item 1. Financial Statements
MERCK & CO., INC. AND SUBSIDIARIES
INTERIM CONSOLIDATED STATEMENT OF INCOME
THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2006 AND 2005
(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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2006 |
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2005 |
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2006 |
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2005 |
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Sales |
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$ |
5,410.4 |
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$ |
5,416.2 |
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$ |
16,591.9 |
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$ |
16,246.0 |
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Costs, Expenses and Other |
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Materials and production |
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1,544.1 |
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1,238.8 |
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4,332.0 |
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3,670.9 |
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Marketing and administrative |
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2,370.6 |
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1,661.4 |
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5,819.6 |
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5,016.4 |
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Research and development |
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945.4 |
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942.6 |
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3,059.9 |
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2,736.0 |
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Restructuring costs |
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49.6 |
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79.8 |
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86.5 |
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93.4 |
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Equity income from affiliates |
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(595.4 |
) |
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(480.1 |
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(1,710.2 |
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(1,130.5 |
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Other (income) expense, net |
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(134.7 |
) |
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(24.7 |
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(305.4 |
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15.8 |
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4,179.6 |
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3,417.8 |
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11,282.4 |
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10,402.0 |
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Income Before Taxes |
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1,230.8 |
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1,998.4 |
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5,309.5 |
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5,844.0 |
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Taxes on Income |
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290.2 |
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577.5 |
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1,349.6 |
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2,332.4 |
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Net Income |
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$ |
940.6 |
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$ |
1,420.9 |
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$ |
3,959.9 |
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$ |
3,511.6 |
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Basic Earnings per Common Share |
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$ |
0.43 |
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$ |
0.65 |
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$ |
1.82 |
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$ |
1.60 |
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Earnings per Common Share Assuming Dilution |
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$ |
0.43 |
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$ |
0.65 |
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$ |
1.81 |
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$ |
1.59 |
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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
SEPTEMBER 30, 2006 AND DECEMBER 31, 2005
(Unaudited, $ in millions)
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September 30, |
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December 31, |
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2006 |
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2005 |
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Assets |
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Current Assets |
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Cash and cash equivalents |
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$ |
6,222.1 |
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$ |
9,585.3 |
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Short-term investments |
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2,864.9 |
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6,052.3 |
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Accounts receivable |
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3,081.4 |
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2,927.3 |
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Inventories (excludes inventories of $447.8 in 2006 and
$753.8 in 2005 classified in Other assets see Note 5) |
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1,870.7 |
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1,658.1 |
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Prepaid expenses and taxes |
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1,185.1 |
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826.3 |
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Total Current Assets |
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15,224.2 |
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21,049.3 |
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Investments |
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6,443.7 |
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1,107.9 |
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Property, Plant and Equipment, at cost, net of allowance for
depreciation of $10,731.0 in 2006 and $9,315.1 in 2005 |
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13,412.8 |
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14,398.2 |
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Goodwill |
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1,085.7 |
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1,085.7 |
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Other Intangibles, net |
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631.8 |
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518.7 |
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Other Assets |
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6,920.9 |
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6,686.0 |
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$ |
43,719.1 |
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$ |
44,845.8 |
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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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$ |
1,195.8 |
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$ |
2,972.0 |
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Trade accounts payable |
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362.6 |
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471.1 |
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Accrued and other current liabilities |
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5,504.9 |
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5,277.8 |
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Income taxes payable |
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3,255.6 |
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3,691.5 |
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Dividends payable |
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828.8 |
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830.0 |
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Total Current Liabilities |
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11,147.7 |
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13,242.4 |
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Long-Term Debt |
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4,789.5 |
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5,125.6 |
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Deferred Income Taxes and Noncurrent Liabilities |
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6,059.6 |
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6,092.9 |
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Minority Interests |
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2,437.0 |
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2,407.2 |
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Stockholders Equity |
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Common Stock |
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Authorized - 5,400,000,000 shares |
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Issued - 2,976,223,337 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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7,105.9 |
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6,900.0 |
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Retained earnings |
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39,447.6 |
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37,980.0 |
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Accumulated other comprehensive income |
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50.1 |
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52.3 |
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46,633.4 |
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44,962.1 |
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Less treasury stock, at cost |
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803,664,097 shares September 30, 2006
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794,299,347 shares December 31, 2005 |
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27,348.1 |
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26,984.4 |
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Total Stockholders Equity |
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19,285.3 |
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17,977.7 |
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$ |
43,719.1 |
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$ |
44,845.8 |
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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
NINE MONTHS ENDED SEPTEMBER 30, 2006 AND 2005
(Unaudited, $ in millions)
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Nine
Months Ended |
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September 30, |
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2006 |
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2005 |
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Cash Flows from Operating Activities |
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Net income |
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$ |
3,959.9 |
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$ |
3,511.6 |
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Adjustments to reconcile net income to cash provided by operating activities: |
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Depreciation and amortization |
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1,725.4 |
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1,202.2 |
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Deferred income taxes |
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(226.1 |
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183.6 |
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Equity income from affiliates |
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(1,710.2 |
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(1,130.5 |
) |
Dividends and distributions from equity affiliates |
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1,372.5 |
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752.0 |
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Share-based compensation |
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246.0 |
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33.5 |
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Acquired research |
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296.3 |
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Other |
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34.5 |
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391.3 |
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Net changes in assets and liabilities |
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(709.2 |
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400.0 |
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Net Cash Provided by Operating Activities |
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4,989.1 |
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5,343.7 |
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Cash Flows from Investing Activities |
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Capital expenditures |
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(684.7 |
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(996.1 |
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Purchase of securities, subsidiaries and other investments |
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(15,983.2 |
) |
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(88,103.8 |
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Proceeds from sale of securities, subsidiaries and other investments |
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13,480.0 |
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86,616.0 |
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Other |
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(1.5 |
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(2.1 |
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Net Cash Used by Investing Activities |
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(3,189.4 |
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(2,486.0 |
) |
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Cash Flows from Financing Activities |
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Net change in short-term borrowings |
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(1,606.6 |
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523.1 |
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Proceeds from issuance of debt |
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5.1 |
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|
1,000.0 |
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Payments on debt |
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(505.6 |
) |
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(1,014.2 |
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Purchase of treasury stock |
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(751.0 |
) |
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(764.0 |
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Dividends paid to stockholders |
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(2,494.0 |
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(2,516.5 |
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Proceeds from exercise of stock options |
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340.8 |
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114.6 |
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Other |
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(172.5 |
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(33.4 |
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Net Cash Used by Financing Activities |
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(5,183.8 |
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(2,690.4 |
) |
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Effect of Exchange Rate Changes on Cash and Cash Equivalents |
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20.9 |
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(128.1 |
) |
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Net (Decrease) Increase in Cash and Cash Equivalents |
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(3,363.2 |
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39.2 |
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Cash and Cash Equivalents at Beginning of Year |
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9,585.3 |
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2,878.8 |
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Cash and Cash Equivalents at End of Period |
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$ |
6,222.1 |
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$ |
2,918.0 |
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The accompanying notes are an integral part of this consolidated financial statement.
- 4 -
Notes to Consolidated Financial Statements
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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Certain reclassifications have been made to prior year amounts to conform with the current
year presentation. |
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Effective January 1, 2006, the Company began recognizing revenue from the sale of vaccines to
the Federal government for placement into stockpiles related to the Pediatric Vaccine
Stockpile in accordance with Securities and Exchange Commission (SEC) Interpretation,
Commission Guidance Regarding Accounting for Sales of Vaccines and BioTerror Countermeasures
to the Federal Government for Placement into the Pediatric Vaccine Stockpile or the Strategic
National Stockpile. The Company retrospectively applied the impacts of adopting the
Interpretation to the Companys consolidated financial statements by reducing Accrued and
other current liabilities by $103.4 million and increasing Income taxes payable by $42.3
million and Retained earnings by $61.1 million, respectively, in its December 31, 2005
consolidated balance sheet. There was no impact to the Companys results of operations for the
nine months ended September 30, 2006 and 2005, respectively. |
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2. |
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Restructuring |
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In November 2005, the Company commenced the initial phase of its global restructuring program
designed to reduce the Companys cost structure, increase efficiency and enhance
competitiveness. As part of this program, the Company plans to sell or close five
manufacturing sites and two preclinical sites by the end of 2008 and eliminate approximately
7,000 positions company-wide. To date, manufacturing operations have ceased at one site, one
other site has been sold, and the two preclinical sites have been closed. The Company has
also sold certain other facilities and related assets in connection with the restructuring
program. Through the end of 2008, when the initial phase of the global restructuring program
is expected to be substantially complete, the cumulative pre-tax costs are expected to range
from $1.8 billion to $2.2 billion. Approximately 70% of the cumulative pre-tax costs are
estimated as non-cash, relating primarily to accelerated depreciation for those facilities
scheduled for closure. Since the inception of the global restructuring program through
September 30, 2006, the Company has recorded total pre-tax accumulated costs of $1.1 billion
and eliminated approximately 3,900 positions which are comprised of employee separations and
the elimination of contractors and vacant positions. |
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The following table summarizes the charges related to restructuring activities by type of cost
for the three and nine months ended September 30, 2006: |
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($ in millions) |
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Three Months Ended September 30, 2006 |
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Nine Months Ended September 30, 2006 |
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Separation |
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Accelerated |
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Separation |
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Accelerated |
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Costs |
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Depreciation |
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Other |
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Total |
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Costs |
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Depreciation |
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Other |
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Total |
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Materials and
production |
|
$ |
|
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|
$ |
187.4 |
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$ |
12.2 |
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|
$ |
199.6 |
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|
$ |
|
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|
$ |
549.0 |
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|
$ |
23.1 |
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|
$ |
572.1 |
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Research and
development |
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55.4 |
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|
55.4 |
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Restructuring
costs |
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|
37.8 |
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11.8 |
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49.6 |
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|
87.4 |
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(0.9 |
) |
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86.5 |
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$ |
37.8 |
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$ |
187.4 |
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|
$ |
24.0 |
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|
$ |
249.2 |
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|
$ |
87.4 |
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|
$ |
604.4 |
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|
$ |
22.2 |
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|
$ |
714.0 |
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For the three and nine months ended September 30, 2006, the Company recorded total pre-tax
restructuring costs of $249.2 million and $714.0 million, respectively, and eliminated
approximately 2,800 positions during 2006 primarily related to the global restructuring
program. The global restructuring program includes the following costs:
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(1) |
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Separation costs related to Company-wide position eliminations, |
- 5 -
Notes to Consolidated Financial Statements (continued)
|
(2) |
|
Accelerated depreciation related to manufacturing and preclinical facilities expected
to be sold or closed by the end of 2008, |
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(3) |
|
Other activity related to the Companys pension and other postretirement plans, asset
impairments, and other exit costs as well as pre-tax gains of $39.5 million for the nine
months ended September 30, 2006 resulting from the sales of facilities in the second
quarter in connection with the global restructuring program. |
The following table summarizes the charges and spending relating to restructuring activities
for the nine months ended September 30, 2006:
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($ in millions) |
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Separation |
|
|
Accelerated |
|
|
|
|
|
|
|
|
|
Costs |
|
|
Depreciation |
|
|
Other |
|
|
Total |
|
Restructuring accrual as of January 1, 2006 (1) |
|
$ |
240.3 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
240.3 |
|
Expense |
|
|
87.4 |
|
|
|
604.4 |
|
|
|
22.2 |
|
|
|
714.0 |
|
(Payments) receipts, net |
|
|
(154.1 |
) |
|
|
|
|
|
|
7.0 |
(2) |
|
|
(147.1 |
) |
Non-cash activity |
|
|
|
|
|
|
(604.4 |
) |
|
|
(29.2 |
) |
|
|
(633.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring accrual as of September 30, 2006 |
|
$ |
173.6 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
173.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The restructuring accrual at January 1, 2006 includes separation costs associated
with the global restructuring program as well as amounts from previously announced
restructuring programs. The previously announced restructuring programs were substantially
complete as of the end of the first quarter. |
|
|
(2) |
|
Includes proceeds from the sales of facilities in the second quarter in connection with
the global restructuring program. |
The Company recorded Restructuring costs for the three and nine months ended September
30, 2005 of $79.8 million and $93.4 million, respectively, associated with earlier
restructuring programs.
3. |
|
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. These plans were approved by the
Companys shareholders. At September 30, 2006, 187.3 million shares were authorized for future
grants under the Companys share-based compensation plans. The Company settles employee
share-based compensation awards primarily with treasury shares. |
|
|
|
Employee stock options are granted to purchase shares of Company stock at the fair market
value at the time of grant. These awards generally vest one-third each year over a three-year
period, with a contractual term of 10 years. RSUs are stock awards that are granted to
employees and entitle the holder to shares of common stock as the awards vest, as well as
non-forfeitable dividend equivalents. The fair value of the awards is determined and fixed on
the grant date based on the Companys stock price. PSUs are stock awards where the ultimate
number of shares issued will be contingent on the Companys performance against a pre-set
objective or set of objectives. The fair value of each PSU is determined on the date of grant
based on the Companys stock price. Over the performance period, the number of shares of stock
that are expected to be issued will be adjusted based on the probability of achievement of a
performance target and final compensation expense will be recognized based on the ultimate
number of shares issued. Both PSU and RSU payouts will be in shares of Company stock after the
end of a three-year period, subject to the terms applicable to such awards. |
|
|
|
Effective January 1, 2006, the Company adopted Financial Accounting Standards No. 123R,
Share-Based Payments (FAS 123R). Employee share-based compensation expense was previously
recognized using the intrinsic value method which measures share-based compensation expense as
the amount at which the market price of the stock at the date of grant exceeds the exercise
price. FAS 123R requires the recognition of the fair value of share-based compensation in net
income, which the Company recognizes on a straight-line basis over the requisite service
period. Additionally, the Company elected the modified prospective transition method for
adopting FAS 123R, and therefore, prior periods were not restated. Under this method, the
provisions for FAS 123R apply to all awards granted or modified after January 1, 2006. In
addition, the unrecognized expense of awards that have not yet vested at the date of adoption
are recognized in net income in the relevant period after the date of adoption. Also effective
January 1, 2006, the Company adopted Financial Accounting Standards Board Staff Position
123R-3, Transition Election Related to Accounting for the Tax Effects of Share-Based Payment
Awards, which provides the Company an optional short cut method for calculating the historical
pool of windfall tax benefits upon adopting FAS 123R. |
- 6 -
Notes to Consolidated Financial Statements (continued)
The following table provides amounts of share-based compensation cost recorded in the
Consolidated Statement of Income (substantially all of the 2005 amount was related to RSUs):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Pre-tax share-based compensation expense |
|
$ |
63.7 |
|
|
$ |
11.8 |
|
|
$ |
246.0 |
|
|
$ |
33.5 |
|
Income tax benefits |
|
|
(20.0 |
) |
|
|
(4.1 |
) |
|
|
(76.3 |
) |
|
|
(11.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
43.7 |
|
|
$ |
7.7 |
|
|
$ |
169.7 |
|
|
$ |
21.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As a result of the adoption of FAS 123R, effective January 1, 2006, the incremental impact on
the Companys share-based compensation expense reduced the Companys results of operations as
follows:
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
Three Months |
|
Nine Months |
|
|
Ended September 30, |
|
|
2006 |
|
2006 |
Income Before Taxes |
|
$ |
42.3 |
|
|
$ |
182.8 |
|
Net Income |
|
|
29.5 |
|
|
|
127.6 |
|
Earnings per Common Share Assuming Dilution |
|
$ |
0.01 |
|
|
$ |
0.06 |
|
FAS 123R requires the Company to present pro forma information for periods prior to the
adoption as if the Company had accounted for employee share-based compensation under the fair
value method of that Statement. For purposes of pro forma disclosure, the estimated fair value
of awards at the date of grant, including those granted to retirement-eligible employees, is
amortized to expense over the requisite service period. The following table illustrates the
effect on net income and earnings per common share if the Company had applied the fair value
method for recognizing employee share-based compensation for the three and nine months ended
September 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
Three Months |
|
|
Nine Months |
|
|
|
Ended September 30, |
|
|
|
2005 |
|
|
2005 |
|
Net income, as reported |
|
$ |
1,420.9 |
|
|
$ |
3,511.6 |
|
Compensation expense, net of tax: |
|
|
|
|
|
|
|
|
Reported |
|
|
7.7 |
|
|
|
21.8 |
|
Fair value method |
|
|
(83.8 |
) |
|
|
(272.6 |
) |
|
|
|
|
|
|
|
Pro forma net income |
|
$ |
1,344.8 |
|
|
$ |
3,260.8 |
|
|
|
|
|
|
|
|
|
Earnings per common share: |
|
|
|
|
|
|
|
|
Basic as reported |
|
$ |
0.65 |
|
|
$ |
1.60 |
|
Basic pro forma |
|
$ |
0.61 |
|
|
$ |
1.48 |
|
|
Assuming dilution as reported |
|
$ |
0.65 |
|
|
$ |
1.59 |
|
Assuming dilution pro forma |
|
$ |
0.61 |
|
|
$ |
1.48 |
|
The pro forma amounts and the fair value of each option grant were estimated on the date of
grant using the Black-Scholes option pricing model. Upon the adoption of FAS 123R,
compensation expense is being recognized immediately for awards granted to retirement-eligible
employees or over the period from the grant date to the date retirement eligibility is
achieved. This approach is known as the non-substantive vesting period approach. If the
Company had been applying this approach for stock options granted to retirement-eligible
employees, the effect on
- 7 -
Notes to Consolidated Financial Statements (continued)
pro forma earnings per share assuming dilution for the three and nine
months ended September 30, 2005, as provided in the above table, would not have been
significant.
The Company continues to use the Black-Scholes option pricing model for option grants after
adoption of FAS 123R. In applying this model, the Company uses both historical data and
current market data to estimate the fair value of its options. The Black-Scholes model
requires several assumptions including expected term of the options,
risk-free rate, volatility, and dividend yield. The expected term represents the expected
amount of time that options granted are expected to be outstanding, based on historical and
forecasted exercise behavior. The risk-free rate is based on the rate at grant date of
zero-coupon U.S. Treasury Notes with a term equal to the expected term of the option. Expected
volatility is estimated using a blend of historical and implied volatility. The historical
component is based on historical monthly price changes. The implied volatility is obtained
from market data on the Companys traded options.
The weighted average fair value of options granted in the first nine months of 2006 was $9.80
per option, determined using the following assumptions:
|
|
|
|
|
Expected dividend yield |
|
|
3.84 |
% |
Risk-free interest rate |
|
|
4.58 |
% |
Expected volatility |
|
|
31.13 |
% |
Expected life (years) |
|
|
5.8 |
|
Summarized information relative to the Companys stock option plans (options in thousands) is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Aggregate |
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
Intrinsic |
|
|
|
Number |
|
|
Average |
|
|
Contractual |
|
|
Value |
|
|
|
of Options |
|
|
Price (1) |
|
|
Term |
|
|
($000s) |
|
Balance at December 31, 2005 |
|
|
250,088.0 |
|
|
$ |
54.52 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
30,704.3 |
|
|
|
35.21 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(11,340.1 |
) |
|
|
30.05 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(13,170.1 |
) |
|
|
57.32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2006 |
|
|
256,282.1 |
|
|
$ |
53.14 |
|
|
|
5.31 |
|
|
$ |
575,804.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2006 |
|
|
194,375.0 |
|
|
$ |
58.48 |
|
|
|
4.21 |
|
|
$ |
149,722.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Weighted average exercise price.
Additional information pertaining to the Companys stock option plans is provided in the
table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Total intrinsic value of stock options exercised |
|
$ |
10.6 |
|
|
$ |
2.2 |
|
|
$ |
55.6 |
|
|
$ |
55.4 |
|
Fair value of stock options vested |
|
$ |
21.1 |
|
|
$ |
24.6 |
|
|
$ |
840.4 |
|
|
$ |
917.8 |
|
Cash received from the exercise
of stock options |
|
$ |
28.9 |
|
|
$ |
4.1 |
|
|
$ |
340.8 |
|
|
$ |
114.6 |
|
- 8 -
Notes to Consolidated Financial Statements (continued)
A summary of the Companys nonvested RSUs and PSUs (shares in thousands) at September 30, 2006,
is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RSUs |
|
|
PSUs |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Average |
|
|
|
Number |
|
|
Grant Date |
|
|
Number |
|
|
Grant Date |
|
|
|
of Shares |
|
|
Fair Value |
|
|
of Shares |
|
|
Fair Value |
|
Nonvested at December 31, 2005 |
|
|
4,765.1 |
|
|
$ |
35.93 |
|
|
|
1,022.2 |
|
|
$ |
39.73 |
|
Granted |
|
|
1,541.4 |
|
|
|
35.15 |
|
|
|
520.7 |
|
|
|
35.09 |
|
Vested |
|
|
(49.7 |
) |
|
|
36.40 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(205.2 |
) |
|
|
35.21 |
|
|
|
(113.7 |
) |
|
|
34.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at September 30, 2006 |
|
|
6,051.6 |
|
|
$ |
35.75 |
|
|
|
1,429.2 |
|
|
$ |
38.44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, 2006, there was $374.9 million of total pre-tax unrecognized compensation
expense related to nonvested stock options, RSU and PSU awards which will be recognized over a
weighted average period of 2.3 years.
4. |
|
Research Collaborations, Acquisitions and License Agreements |
|
|
|
Merck continues its strategy of establishing strong external alliances to complement its
substantial internal research capabilities, including targeted acquisitions, research
collaborations, licensing pre-clinical and clinical compounds and technology transfers to
drive both near- and long-term growth. |
|
|
|
In September 2006, the Company announced that it will expand the scope of its existing
strategic collaboration with FoxHollow Technologies, Inc. (FoxHollow) for atherosclerotic
plaque analysis and that Merck will acquire a stake in FoxHollow with the purchase of $95
million in common stock, subject to customary closing conditions and clearance under the
Hart-Scott-Rodino Antitrust Improvements Act. Merck will acquire newly-issued shares of
FoxHollow common stock at $29.629 per share, representing approximately an 11% stake. Under
the terms of the expanded collaboration agreement, Merck will pay $40 million to FoxHollow
over four years in exchange for FoxHollows agreement to collaborate exclusively with Merck in
specified disease areas. Merck will also provide a minimum of $60 million in funding to
FoxHollow over the first three years of the four year collaboration program term, for research
activities to be conducted by FoxHollow under Mercks direction. FoxHollow will receive
milestone payments on successful development of drug products or diagnostic tests utilizing
results from the collaboration, as well as royalties. This transaction is expected to close in
the fourth quarter of 2006. |
|
|
|
In June 2006, the Company acquired all of the outstanding equity of GlycoFi, Inc. (GlycoFi)
for approximately $373 million in cash ($400 million purchase price net of $25 million in
shares already owned and net transaction costs). GlycoFi was a privately-held biotechnology
company that was a leader in the field of yeast glycoengineering, which is the addition of
specific carbohydrate modifications to the proteins in yeast, and optimization of biologic
drug molecules. GlycoFis technology platform is used in the development of glycoprotein, as
well as the optimization of a glycoprotein target. In connection with the acquisition, the
Company recorded a charge of $296.3 million for acquired research associated with GlycoFis
technology platform to be used in the research and development process, for which, at the
acquisition date, technological feasibility had not been established and no alternative future
use existed. This charge is not deductible for tax purposes. The Company expects this
technology to be fully developed over the next one to two years. The charge was recorded in
Research and development expense in the second quarter and was determined based upon the
present value of expected future cash flows of new product candidates resulting from this
technology adjusted for the probability of its technical and marketing success utilizing an
income approach reflecting the appropriate risk-adjusted discount rate. The Company also
recorded a $99.4 million intangible asset ($57.6 million net of deferred taxes) in the second
quarter related to GlycoFis developed technology that can be used immediately in the research
and development process and has alternative future uses. This intangible asset will be
amortized to Research and development expense on a straight-line basis over a five year useful
life. The remaining net assets acquired in this transaction were not material. Because
GlycoFi was a development stage company that had not commenced its planned principal
operations, the transaction was accounted for as an acquisition of assets rather than as a
business combination and, therefore, goodwill was not recorded. GlycoFis results of
operations have been included with the Companys consolidated financial results since the
acquisition date. |
- 9 -
Notes to Consolidated Financial Statements (continued)
In May 2006, the Company acquired all of the equity of Abmaxis, Inc. (Abmaxis) for
approximately $80 million in cash. Abmaxis was a privately-held biopharmaceutical company
dedicated to the discovery and optimization of monoclonal antibody (MAb) products for human
therapeutics and diagnostics. Abmaxis developed and validated a breakthrough antibody
engineering technology platform, Abmaxis in-silico Immunization, which has alternative
future uses to the Company with no significant technological or engineering risks at the date
of acquisition. In connection with the acquisition, the Company allocated substantially all
of the purchase price to Abmaxis technology platform and recorded an intangible asset of
$135.3 million ($78.5 million net of deferred taxes). This intangible asset will be amortized
to Research and development expense on a straight-line basis over a five year useful life. The
remaining net assets acquired in this transaction were not material. Because Abmaxis was a
development stage company that had not commenced its planned principal operations, the
transaction was accounted for as an acquisition of assets rather than as a business
combination and, therefore, goodwill was not recorded. Abmaxis results of operations have
been included with the Companys consolidated financial results since the acquisition date.
In March 2006, Merck and Paratek Pharmaceuticals, Inc. (Paratek) announced they entered into
an exclusive, worldwide collaborative development and license
agreement for PTK 0796 (MK-2764), a novel,
broad-spectrum aminomethylcycline (AMC) antibiotic with oral and intravenous (IV) formulations
currently in Phase I clinical testing. Under the terms of the agreement, Merck provided
upfront funding, will assume primary responsibility for clinical development of the IV and
oral formulations of PTK 0796 and has the right to market such products worldwide. Paratek
will participate in clinical development and be eligible to receive payments upon achievement
of certain milestones; these payments could total as much as $127 million once PTK 0796 is
approved for marketing. Paratek will also receive royalties on net sales and have the
opportunity to co-promote the IV formulation of PTK 0796 in the United States.
In March 2006, Neuromed Pharmaceuticals Ltd. (Neuromed) and Merck signed a research
collaboration and license agreement to research, develop and commercialize novel compounds for
the treatment of pain and other neurological disorders, including Neuromeds lead compound,
NMED-160 (MK-6721), which is currently in Phase II development for the treatment of pain. Under the
terms of the agreement, Neuromed received an upfront payment of $25 million which the Company
recorded as Research and development expense. The successful development and launch of
NMED-160 for an initial single indication on a worldwide basis would trigger milestone
payments totaling $202 million. Milestones could increase to approximately $450 million if a
further indication for NMED-160 is developed and approved and an additional compound is
developed and approved for two indications. Neuromed would also receive royalties on worldwide
sales of NMED-160 and any additional compounds developed under this agreement.
Also in March 2006, Merck signed an agreement with NicOx S.A. (NicOx) to collaborate on the
development of new antihypertensive drugs using NicOxs proprietary nitric oxide-donating
technology. Under the terms of the agreement, NicOx received an upfront payment of
approximately $11.2 million, which the Company recorded as Research and development expense,
and is eligible for potential further milestone payments of approximately $340.2 million.
Merck will also pay NicOx royalties on the sales of all products resulting from the
collaboration.
- 10 -
Notes to Consolidated Financial Statements (continued)
5. |
|
Inventories |
|
|
|
Inventories consisted of: |
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Finished goods |
|
$ |
448.8 |
|
|
$ |
400.0 |
|
Raw materials and work in process |
|
|
1,780.0 |
|
|
|
1,929.8 |
|
Supplies |
|
|
89.7 |
|
|
|
82.1 |
|
|
|
|
|
|
|
|
Total (approximates current cost) |
|
|
2,318.5 |
|
|
|
2,411.9 |
|
Reduction to LIFO cost for domestic inventories |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,318.5 |
|
|
$ |
2,411.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized as: |
|
|
|
|
|
|
|
|
Inventories |
|
$ |
1,870.7 |
|
|
$ |
1,658.1 |
|
Other assets |
|
$ |
447.8 |
|
|
$ |
753.8 |
|
|
|
Amounts recognized as Other assets are comprised entirely of raw materials and work in process
inventories, which include inventories for products not expected to be sold within one year,
principally vaccines and Arcoxia, and, as of December 31, 2005, inventories produced in
preparation for product launches. |
|
6. |
|
Debt and Financial Instruments |
|
|
|
In July 2006, $500 million of 5.25% notes, along with an associated pay-floating,
receive-fixed interest rate swap, matured and were retired. |
|
|
|
In April and May 2006, respectively, the Company entered into pay-floating, receive-fixed
interest rate swap contracts each effectively converting $250 million of its $1.0 billion,
4.75% fixed-rate notes to floating rate instruments. The interest rate swaps are designated
as hedges of the fair value changes in the notes attributable to changes in the benchmark
London Interbank Offered Rate (LIBOR) swap rate and will mature in 2015. The fair value
changes in the notes are fully offset in interest expense by the fair value changes in the
swap contract. |
|
|
|
In April 2006, the Company extended the maturity date of its $1.5 billion, 5-year revolving
credit facility from 2010 to 2011. 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. |
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7. |
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Contingencies |
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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. |
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Vioxx Litigation |
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Product Liability Lawsuits |
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|
As previously disclosed, federal and state product liability lawsuits involving individual
claims, as well as putative class actions, have been filed against the Company with respect to
Vioxx. As of October 9, 2006, the Company had been served or was aware that it had been named
as a defendant in approximately 23,800 lawsuits filed on or before September 30, which include
approximately 41,750 plaintiff groups, alleging personal injuries resulting from the use of
Vioxx. Of these lawsuits, approximately 7,450 lawsuits representing approximately 21,950
plaintiff groups are or are slated to be in the federal MDL (discussed below) and
approximately 13,850 lawsuits
|
- 11 -
Notes to Consolidated Financial Statements (continued)
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representing approximately 13,850 plaintiff groups are included
in a coordinated proceeding in New Jersey Superior Court before Judge Carol E. Higbee.
Certain of these lawsuits include allegations regarding gastrointestinal bleeding,
cardiovascular events, thrombotic events or kidney damage. The Company has also been named as
a defendant in approximately 275 putative class actions alleging personal injuries or seeking
(i) medical monitoring as a result of the putative class members use of Vioxx, (ii)
disgorgement of certain profits under common law unjust enrichment theories, and/or (iii)
various remedies under state consumer fraud and fair business practice statutes, including
recovering the cost of Vioxx purchased by individuals and third-party payors such as union
health plans (all of the actions discussed in this paragraph are collectively referred to as
the Vioxx Product Liability Lawsuits). The actions filed in the state courts of California,
Texas, and New Jersey, and in the counties of Philadelphia, Pennsylvania, and Clark County,
Nevada have been transferred to a single state court in each location for
coordinated proceedings. |
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In addition to the Vioxx Product Liability Lawsuits discussed above, the claims of over 3,000
plaintiff groups have been dismissed to date. Of these, there have been over 1,100 plaintiff
groups whose claims were dismissed with prejudice (i.e., they can not be brought again) either
by plaintiffs themselves or by the courts. Over 2,000 additional plaintiff groups have had
their claims dismissed without prejudice (i.e., they can be brought again). |
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On February 16, 2005, the Judicial Panel on Multidistrict Litigation (the JPML) transferred
all Vioxx Product Liability Lawsuits pending in federal courts nationwide into one
Multidistrict Litigation (MDL) for coordinated pre-trial proceedings. The MDL has been
transferred to the United States District Court for the Eastern District of Louisiana before
District Judge Eldon E. Fallon. |
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In July 2005, Judge Fallon indicated that he would schedule for trial a series of cases during
the period November 2005 through 2006, in the following categories: (i) heart attack with
short term use; (ii) heart attack with long term use; (iii) stroke; and (iv) cardiovascular
injury involving a prescription written after April 2002 when the labeling for Vioxx was
revised to include the results of the VIGOR trial. These trials began in November 2005 and
the trials that took place since June 30, 2006 are described in further detail below. |
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Merck has entered into a tolling agreement (the Tolling Agreement) with the MDL Plaintiffs
Steering Committee that establishes a procedure to halt the running of the statute of
limitations (tolling) as to certain categories of claims allegedly arising from the use of
Vioxx by non-New Jersey citizens. The Tolling Agreement applies to individuals who have not
filed lawsuits and may or may not eventually file lawsuits and only to those claimants who
seek to toll claims alleging injuries resulting from a thrombotic cardiovascular event that
results in a myocardial infarction or ischemic stroke. The Tolling Agreement provides counsel
additional time to evaluate potential claims. The Tolling Agreement requires any tolled
claims to be filed in federal court. As of October 9, 2006, approximately 15,000 claimants
had entered into Tolling Agreements on or before September 30, 2006. |
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The Company has previously disclosed the outcomes of several Vioxx Product Liability Lawsuits
that were tried prior to June 30, 2006. |
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In July 2006, in Doherty v. Merck, in Superior Court of New Jersey, Law Division, Atlantic
County, a jury returned a verdict in favor of the Company on all counts. The jury rejected a
claim by the plaintiff that her nearly three years of Vioxx use caused her heart attack. The
jury also found in Mercks favor on the plaintiffs consumer fraud claim. |
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In August 2006, in the first case to go to trial in the California coordinated proceeding,
Grossberg v. Merck, the jury in Los Angeles, California returned a verdict for Merck on all
counts. |
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In August 2006, in Barnett v. Merck, a case before Judge Fallon in the MDL, a jury in New
Orleans, Louisiana returned a plaintiff verdict in the second federal
Vioxx case to go to trial.
The jury awarded $50 million in compensatory damages and $1 million in punitive damages. On
August 30, 2006, Judge Fallon overturned as excessive the damages portion of the verdict and
ordered a new trial on damages. The Company is seeking a new trial on all issues. |
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On September 26, 2006, in Smith v. Merck, the third case to go to trial in the federal MDL, a
jury returned a verdict in favor of Merck on all counts. |
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The Company previously disclosed that in April 2006, in Garza v. Merck, a jury in Rio Grande
City, Texas returned a verdict in favor of the plaintiff. In September 2006, the Texas state
court granted the Companys request to investigate possible jury bias because a juror admitted
that he had, prior to the trial, on several occasions borrowed money from the plaintiff. |
- 12 -
Notes to Consolidated Financial Statements (continued)
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In August 2006, Judge Fallon granted the Companys motion to dismiss two Vioxx class action
claims previously filed in the federal court; one claim filed by plaintiffs from France and
the other claim by plaintiffs from Italy. |
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In August 2006, Judge Higbee set aside the November 2005 jury verdict in favor of Merck in
Humeston v. Merck and ordered a new trial on the grounds of newly discovered evidence. The
Company has filed a motion for reconsideration of Judge Higbees decision to re-try the case. |
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On September 19, 2006, Merck filed a notice of appeal of the previously disclosed August 2005
jury verdict in favor of the plaintiff in the Texas state court case, Ernst v. Merck. Among
several independent grounds for reversal, the Company will argue that there was insufficient
evidence that Mr. Ernst suffered an injury due to Vioxx and that it was improper to allow
testimony by a previously undisclosed witness midway through the trial. In the interim, as
required under Texas law, the Company has posted an appeal bond. |
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On September 28, 2006, the New Jersey Superior Court, Appellate Division, heard argument on
plaintiffs appeal of Judge Higbees dismissal of the Sinclair v. Merck case. This putative
class action was originally filed in December 2004 and sought the creation of a medical
monitoring fund. Judge Higbee had granted the Companys motion to dismiss in May 2005. |
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On October 5, 2006, Judge Higbee dismissed the United Kingdom plaintiffs from the New Jersey
Coordinated Proceeding. |
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The first case scheduled for trial in the Texas coordinated proceeding, Rigby v. Merck, was
scheduled to begin trial on November 7, 2006. The Rigby case was voluntarily dismissed on
October 23, 2006 when the plaintiff filed a non-suit with the Court. |
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The trial in Mason v. Merck, a case in federal court in Louisiana, started on October 30,
2006. On October 31, 2006 in California Superior Court in Los Angeles, a consolidated trial
began in the cases Appell v. Merck and Arrigale v. Merck. |
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The next trial in New Jersey is currently scheduled to start on January 16, 2007, and the
Court has stated that it will be a consolidated trial including multiple plaintiffs.
Plaintiffs proposed eight cases to be joined together for a consolidated trial. Merck filed
motions opposing the concept of a consolidated trial proceeding and challenging the propriety
of plaintiffs proposed cases. |
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Merck voluntarily withdrew Vioxx from the market on September 30, 2004. Many states have a
two-year statute of limitations for product liability claims, requiring that claims must be
filed within two years after the plaintiffs learned or could have learned of their potential
cause of action. As a result, some may view September 30, 2006 as a deadline for filing Vioxx
cases. It is important to note, however, that the law regarding statutes of limitations can
be complex, varies from state to state, can be fact-specific, and in some cases, might be
affected by the existence of pending class actions. For example, some states have three year
statutes of limitations and, in some instances, the statute of limitations is even longer.
Merck expects that there will be legal arguments concerning the proper application of these
statutes, and the decisions will be up to the judges presiding in individual cases in state
and federal proceedings. As referred to above, as of September 30, 2006, Merck has also
entered into agreements with approximately 15,000 claimants to toll the statute of
limitations, so the September 30, 2006 date would not apply in those instances. |
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Other Lawsuits |
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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 seeks 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. Merck believes that the class was improperly certified.
The trial courts ruling is procedural only; it does not address the merits of plaintiffs
allegations, which the Company intends to defend vigorously. On March 31, 2006, the New
Jersey Superior Court, Appellate Division, affirmed the class certification order. On July
19, 2006, the New Jersey Supreme Court decided to exercise its discretion to hear the
Companys appeal of the Appellate Divisions decision. On August 24, 2006, the Appellate
Division ordered a stay of the proceedings in Superior Court pending a ruling by the Supreme
Court. |
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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 Alaska, Louisiana, Mississippi, Montana, Texas and Utah.
These actions allege that the Company misrepresented the safety of Vioxx and seek (i) recovery
of the cost of Vioxx purchased or reimbursed by
|
- 13 -
Notes to Consolidated Financial Statements (continued)
|
|
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. |
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|
|
Shareholder Lawsuits |
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|
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 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. Plaintiffs request certification of a class of purchasers of Company stock between
May 21, 1999 and October 29, 2004. The complaint alleges 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 seeks unspecified compensatory damages and the costs of
suit, including attorneys fees. The complaint also asserts a claim under Section 20A of the
Securities and Exchange Act against certain defendants relating to their sales of Merck stock.
In addition, the complaint includes allegations under Sections 11, 12 and 15 of the
Securities Act of 1933 that certain defendants made incomplete and misleading statements in a
registration statement and certain prospectuses filed in connection with the Merck Stock
Investment Plan, a dividend reinvestment plan. Defendants have filed a motion to dismiss the
complaint, which is pending. |
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|
As previously disclosed, on August 15, 2005, a complaint was filed in Oregon state court by
the State of Oregon through the Oregon state treasurer on behalf of the Oregon Public Employee
Retirement Fund against the Company and certain current and former officers and directors.
The complaint, which was brought under Oregon securities law, alleges that plaintiff has
suffered damages in connection with its purchases of Merck common stock at artificially
inflated prices due to the Companys alleged violations of law related to disclosures about
Vioxx. The current and former officers and directors have entered into a tolling agreement
and, on June 30, 2006, were dismissed without prejudice from the case. On July 19, 2006, the
Court denied the Companys motion to dismiss the complaint, but required plaintiff to amend
the complaint. Plaintiff filed an amended complaint on September 21, 2006. Merck intends to
file a motion to dismiss the amended complaint. |
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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). The consolidated complaint arose out of substantially the same
factual allegations that are made in the Vioxx Securities Lawsuits. The derivative suits,
which were purportedly brought to assert rights of the Company, assert claims against certain
members of the Board past and present and certain executive officers for breach of fiduciary
duty, waste of corporate assets, unjust enrichment, abuse of control and gross mismanagement.
On May 5, 2006, Judge Chesler granted defendants motion to dismiss and denied plaintiffs
request for leave to amend their complaint. Plaintiffs appealed the District Courts decision
refusing them leave to amend to the United States Court of Appeals for the Third Circuit. |
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|
As previously disclosed, on October 29, 2004, two individual shareholders made a demand on the
Board of Directors of the Company 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 July
2006, the Board received another shareholder letter demanding that the Board take legal action
against the Board and management of Merck for allegedly causing damage to the Company relating
to the Companys allegedly improper marketing of Vioxx. These requests remain under
consideration. |
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|
As previously announced, the Board of Directors appointed a Special Committee to review the
Companys actions prior to its voluntary withdrawal of Vioxx, to act for the Board in
responding to shareholder litigation matters related to the withdrawal of Vioxx, and to advise
the Board with respect to any action that should be taken as a result of the review. In
December 2004, the Special Committee retained the Honorable John S. Martin, Jr. of Debevoise &
Plimpton LLP to conduct an independent investigation of senior managements conduct with
respect to the cardiovascular safety profile of Vioxx during the period Vioxx was developed
and marketed. The review was completed in the third quarter of 2006 and the full report
(including appendices) was made public in September 2006. |
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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
|
- 14 -
Notes to Consolidated Financial Statements (continued)
|
|
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 October 7, 2005,
defendants moved to dismiss the ERISA complaint. On July 11, 2006, Judge Chesler granted in
part and denied in part defendants motion to dismiss. |
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|
International Lawsuits |
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|
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, Australia, Turkey, and Israel. |
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|
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Additional Lawsuits |
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|
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 |
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|
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 that have been or will be incurred in connection with the Vioxx
Product Liability Lawsuits. The Company believes that this insurance coverage extends to
additional Vioxx Product Liability Lawsuits that may be filed in the future. The Company has
Directors and Officers insurance coverage applicable to the Vioxx Securities Lawsuits and
Vioxx Derivative Lawsuits with stated upper limits of approximately $190 million. The Company
has fiduciary and other insurance for the Vioxx ERISA Lawsuits with stated upper limits of
approximately $275 million. Additional insurance coverage for these claims may also be
available under upper-level excess policies that provide coverage for a variety of risks.
There are disputes with certain insurers about the availability of some or all of this
insurance coverage and there are likely to be additional disputes. At this time, the Company
believes that its insurance coverage with respect to the Vioxx Lawsuits will not be adequate
to cover its defense costs and any losses. |
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|
|
As previously disclosed, the Companys upper level excess insurers (which provide excess
insurance potentially applicable to all of the Vioxx Lawsuits) have commenced an arbitration
seeking, among other things, to cancel those policies, to void all of their obligations under
those policies and to raise other coverage issues with respect to the Vioxx Lawsuits. A
second arbitration against one of the Companys upper level excess insurers has also been
commenced. Merck intends to contest vigorously the insurers claims and will attempt to
enforce its rights under applicable insurance policies. The amounts actually recovered under
the policies discussed in this section may be less than the amounts specified in the preceding
paragraph. |
|
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Investigations |
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|
As previously disclosed, in November 2004, the Company was advised by the staff of the SEC
that it was commencing an informal inquiry concerning Vioxx. On January 28, 2005, the Company
announced that it received notice that the SEC issued a formal notice of investigation. Also,
the Company has received subpoenas from the U.S. Department of Justice (the DOJ) requesting
information related to the Companys research, marketing and selling activities with respect
to Vioxx in a federal health care investigation under criminal statutes. In addition, as
previously disclosed, investigations are being conducted by local authorities in certain
cities in Europe in order to determine whether any criminal charges should be brought
concerning Vioxx. The Company is cooperating with these governmental entities in their
respective investigations (the Vioxx Investigations). The Company cannot predict the
outcome of these inquiries; however, they could result in potential civil and/or criminal
dispositions. |
|
|
|
As previously disclosed, the Company has received a number of Civil Investigative Demands
(CID) from a group of Attorneys General from 31 states and the District of Columbia who are
investigating whether the Company violated state consumer protection laws when marketing
Vioxx. The Company is cooperating with the Attorneys General in responding to the CIDs. |
|
|
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Reserves |
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|
The Company currently anticipates that a number of Vioxx Product Liability Lawsuits will be
tried in the last quarter of 2006 and throughout 2007. The Company
anticipates that the trial in the Oregon securities case will be held in 2007, but the Company cannot predict whether this trial
will proceed on schedule or the timing of any of the other Vioxx Shareholder Lawsuit trials.
The Company believes that it has meritorious defenses to the Vioxx Lawsuits and will
|
- 15 -
Notes to Consolidated Financial Statements (continued)
|
|
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. The Company has not established any reserves for any potential liability
relating to the Vioxx Lawsuits or the Vioxx Investigations, 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, 2005, the Company had established
a reserve of $685 million solely for its future legal defense costs related to the Vioxx
Litigation. |
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|
During the first nine months of 2006, the Company spent $325 million in the aggregate in legal
defense costs worldwide related to (i) the Vioxx Product Liability Lawsuits, (ii) the Vioxx
Shareholder Lawsuits, (iii) the Vioxx Foreign Lawsuits, and (iv) the Vioxx Investigations
(collectively, the Vioxx Litigation). In the third quarter, the Company recorded a charge
of $598 million to increase the reserve solely for its future legal defense costs related to
the Vioxx Litigation to $958 million at September 30, 2006. In increasing the reserve, the
Company considered the same factors that it considered when it previously established reserves
for the Vioxx Litigation. Management now believes it has a better estimate of the Companys
expenses and can reasonably estimate such costs through 2008. Some of the significant factors
considered in the establishment and ongoing review of the reserve for the Vioxx legal defense
costs 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;
the number of cases being brought against the Company; the costs and outcomes of completed
trials and the anticipated timing, progression, and related costs of pre-trial activities and
trials in the Vioxx Product Liability Lawsuits. Events such as scheduled trials, that are
expected to occur throughout 2007 and into 2008, and the inherent inability to predict the
ultimate outcomes of such trials, limit the Companys ability to reasonably estimate its legal
costs beyond the end of 2008. 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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Governmental Proceedings |
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|
As previously disclosed, the Company has received a subpoena from the DOJ in connection with
its investigation of the Companys marketing and selling activities, including nominal pricing
programs and samples. The Company has been advised that the activities being investigated by
the DOJ are also the subject of a qui tam complaint. As previously disclosed, the Company has
received CIDs from the Attorney General of Texas regarding the Companys marketing and selling
activities relating to Texas. In April 2004, the Company received a subpoena from the office
of the Inspector General for the District of Columbia in connection with an investigation of
the Companys interactions with physicians in the District of Columbia, Maryland, and
Virginia. In November 2004, the Company received a letter request from the DOJ in connection
with its investigation of the Companys pricing of Pepcid. In September 2005, the Company
received a subpoena from the Illinois Attorney General seeking information related to
repackaging of prescription drugs. |
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|
As previously disclosed, the Company has received a letter from the DOJ advising it of the
existence of a qui tam complaint alleging that the Company violated certain rules related to
its calculations of best price and other federal pricing benchmark calculations, certain of
which may affect the Companys Medicaid rebate obligation. The DOJ has informed the Company
that it does not intend to intervene in this action and has closed its investigation. The
lawsuit continues, however. |
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|
The Company is cooperating with all of these investigations. The Company cannot predict the
outcome of these investigations; however, it is possible that unfavorable outcomes could have
a material adverse effect on the Companys financial position, liquidity and results of
operations. In addition, from time to time, other federal, state or foreign regulators or
authorities may seek information about practices in the pharmaceutical industry or the
Companys business practices in inquiries other than the investigations discussed in this
section. It is not feasible to predict the outcome of any such inquiries. |
- 16 -
Notes to Consolidated Financial Statements (continued)
8. |
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Taxes on Income |
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|
As previously disclosed, the Internal Revenue Service (IRS) has substantially completed its
examination of the Companys tax returns for the years 1993 to 1996. The IRS is now in the
process of concluding its examination for years 1996 through 2001. The Company and the IRS
anticipate that the examination will be completed by the end of the year. The following
significant open items have yet to be resolved; however the Company is attempting to resolve
the items through the IRS administrative processes. |
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On September 26, 2006, in connection with its examination, the IRS issued a notice of proposed
adjustment (the 2006 Notice) for the years 1994-2001 with respect to a partnership
transaction entered into in 1993. As previously reported, the Company had previously received
a final notice of deficiency with respect to the transaction for the 1993 tax return. The
2006 Notice disallowed certain royalty and other expenses claimed as deductions on the tax
returns for 1994 through 2001. If the IRS ultimately prevails in its positions, the Companys
income tax due for year 1993 would increase by approximately $60 million plus interest of
approximately $70 million and penalties of approximately $12 million. For the years
1994-2001, the tax would increase by approximately $1,150 million plus interest of
approximately $700 million. The IRS will likely make similar claims for years subsequent to
2001 with respect to this transaction. The potential disallowance for these later years,
computed on a similar basis to the 1993-2001 disallowances, would be approximately $300
million plus interest of approximately $30 million. The IRS has proposed penalties on the
Company with respect to 1993 through 2001 and the Company anticipates the IRS would seek to
impose penalties on years subsequent to 2001. |
|
|
|
On September 25, 2006, the Company received a notice of proposed adjustment relating to a 1995
minority interest equity financing. The notice proposes a disallowance of a capital loss
which would increase the tax due for 1995 to 1998 by approximately $330 million plus interest
of $150 million. In addition, the IRS proposes recharacterizing a loan from a foreign
subsidiary to the Company as a taxable distribution resulting in an additional $330 million of
tax due plus interest of $210 million. |
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|
In addition, on September 25, 2006, the Company received a notice of proposed adjustment
relating to a minority interest equity financing entered into in 2000. The IRS proposes to
include as income certain loans made by a foreign subsidiary to the Company. Such an
adjustment would increase the tax due for 2000 and 2001 by approximately $160 million plus
interest of $40 million. Similarly, the Company anticipates that the IRS position would
increase the Companys US income for 2002-2004 resulting in additional tax due for 2002
through 2004 by approximately $250 million plus interest of $30 million. The IRS has proposed
penalties on the Company with respect to all periods that were the subject of the preliminary
notice of adjustment with respect to this transaction and the Company anticipates the IRS
would seek to impose penalties on all other periods. |
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|
The Company disagrees with the proposed adjustments and intends to pursue these matters
through applicable IRS and judicial procedures, as appropriate. The Company has provided for
the best estimate of the probable tax liability for these matters. While the resolution of
these issues may result in tax liabilities which are significantly higher or lower than the
reserves established for this matter, management currently believes that the resolution will
not have a material adverse effect on the Companys financial position or liquidity. However,
an unfavorable resolution could have a material adverse effect on the Companys results of
operations in the quarter in which an adjustment is recorded and any settlement is likely to
have a material adverse effect on the Companys cash flows in the quarter that such payment is
made. |
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|
|
As previously disclosed, Mercks Canadian tax returns for the years 1998 through 2004 are
being examined by the Canada Revenue Agency (CRA). On October 10, 2006, CRA issued the
Company a notice of reassessment containing adjustments related to certain intercompany
pricing matters which result in additional tax due of approximately $ 1.4 billion (US dollars)
plus interest of $360 million (US dollars). The Company disagrees with the positions taken by
CRA and believes they are without merit. The Company may be required to post a deposit of up
to one half the tax and interest assessed which could have a material adverse effect on the
Companys cash flows in the quarter in which the deposit is made. The Company intends to
contest the assessment through the CRA appeals process and the courts if necessary.
Management believes that resolution of these matters will not have a material adverse 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 the tax is due. |
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|
|
As previously disclosed, in October 2004, the American Jobs Creation Act of 2004 (the AJCA)
was signed into law. The AJCA created temporary incentives for U.S. multinationals to
repatriate accumulated income earned outside the United States as of December 31, 2002. In
accordance with the AJCA, the Company recorded an income tax charge of $740 million in Taxes
on Income in the second quarter of 2005 related to the $15.9 billion repatriated
|
- 17 -
Notes to Consolidated Financial Statements (continued)
|
|
during 2005.
This charge was partially offset by a $100 million benefit with a decision to implement
certain tax
planning strategies. The Company has not changed its intention to indefinitely reinvest
accumulated earnings earned subsequent to December 31, 2002. No provision will be made for
income taxes that would be payable upon the distributions of such earnings and it is not
practicable to determine the amount of the related unrecognized deferred income tax liability.
In addition, the Company has subsidiaries operating in Puerto Rico and Singapore under tax
incentive grants that expire in 2015 and 2026, respectively. |
|
9. |
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Pension and Other Postretirement Benefit Plans |
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|
The Company has defined benefit pension plans covering eligible employees in the United States
and in certain of its international subsidiaries. The net cost of such plans consisted of the
following components: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Service cost |
|
$ |
89.2 |
|
|
$ |
81.0 |
|
|
$ |
269.5 |
|
|
$ |
242.1 |
|
Interest cost |
|
|
85.5 |
|
|
|
77.6 |
|
|
|
255.6 |
|
|
|
234.8 |
|
Expected return on plan assets |
|
|
(110.3 |
) |
|
|
(99.2 |
) |
|
|
(327.6 |
) |
|
|
(300.4 |
) |
Net amortization |
|
|
42.0 |
|
|
|
37.9 |
|
|
|
126.9 |
|
|
|
114.5 |
|
Termination benefits |
|
|
2.1 |
|
|
|
5.6 |
|
|
|
18.3 |
|
|
|
10.2 |
|
Curtailments |
|
|
|
|
|
|
|
|
|
|
0.2 |
|
|
|
|
|
Settlements |
|
|
15.0 |
|
|
|
|
|
|
|
15.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
123.5 |
|
|
$ |
102.9 |
|
|
$ |
357.9 |
|
|
$ |
301.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
benefits plans. The net cost of such plans consisted of the following components: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Service cost |
|
$ |
24.6 |
|
|
$ |
22.1 |
|
|
$ |
66.5 |
|
|
$ |
66.2 |
|
Interest cost |
|
|
26.9 |
|
|
|
26.3 |
|
|
|
77.1 |
|
|
|
79.1 |
|
Expected return on plan assets |
|
|
(30.6 |
) |
|
|
(25.8 |
) |
|
|
(87.0 |
) |
|
|
(77.5 |
) |
Net amortization |
|
|
0.6 |
|
|
|
5.4 |
|
|
|
2.4 |
|
|
|
16.2 |
|
Termination benefits |
|
|
0.4 |
|
|
|
0.8 |
|
|
|
2.6 |
|
|
|
1.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
21.9 |
|
|
$ |
28.8 |
|
|
$ |
61.6 |
|
|
$ |
85.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In connection with restructuring actions (see Note 2), the Company recorded termination
charges for the three and nine months ended September 30, 2006 and 2005, on its pension plans
and its other postretirement benefit plans related to expanded eligibility for certain
employees exiting the Company. Also, in connection with these restructuring actions, the
Company recorded curtailment losses for the nine months ended September 30, 2006 on its
pension plans. |
|
|
|
The Company also recorded settlement losses on certain of its domestic pension plans primarily
resulting from employees electing to receive their pension benefits as lump sum payments. |
|
|
|
The Company expects contributions to its defined benefit pension plans will total
approximately $430 million during 2006. |
- 18 -
Notes to Consolidated Financial Statements (continued)
10. |
|
Other (Income) Expense, Net |
|
|
|
Other (income) expense, net, consisted of: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Interest income |
|
$ |
(195.0 |
) |
|
$ |
(122.3 |
) |
|
$ |
(564.6 |
) |
|
$ |
(314.8 |
) |
Interest expense |
|
|
87.7 |
|
|
|
99.6 |
|
|
|
277.8 |
|
|
|
277.2 |
|
Exchange gains |
|
|
(11.5 |
) |
|
|
(7.4 |
) |
|
|
(4.5 |
) |
|
|
(16.5 |
) |
Minority interests |
|
|
30.7 |
|
|
|
30.9 |
|
|
|
90.7 |
|
|
|
91.6 |
|
Other, net |
|
|
(46.6 |
) |
|
|
(25.5 |
) |
|
|
(104.8 |
) |
|
|
(21.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(134.7 |
) |
|
$ |
(24.7 |
) |
|
$ |
(305.4 |
) |
|
$ |
15.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in interest income reflects interest income generated from the Companys
investment portfolio derived from higher interest rates and higher average investment
portfolio balances. |
|
|
|
Interest paid for the nine months ended September 30, 2006 and 2005, was $317.8 million and
$288.2 million, respectively. |
|
11. |
|
Earnings Per Share |
|
|
|
The weighted average common shares used in the computations of basic earnings per common share
and earnings per common share assuming dilution (shares in millions) are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Average common shares outstanding |
|
|
2,175.2 |
|
|
|
2,194.0 |
|
|
|
2,180.1 |
|
|
|
2,200.9 |
|
Common shares issuable(1) |
|
|
10.5 |
|
|
|
3.0 |
|
|
|
8.4 |
|
|
|
3.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average common shares outstanding
assuming dilution |
|
|
2,185.7 |
|
|
|
2,197.0 |
|
|
|
2,188.5 |
|
|
|
2,204.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Issuable primarily under share-based compensation plans. |
|
|
For the three and nine months ended September 30, 2006, 194.7 million and 222.8 million,
respectively, and for the three and nine months ended September 30, 2005, 247.5 million 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. |
|
12. |
|
Comprehensive Income |
|
|
|
Comprehensive income representing all changes in stockholders equity during the period other
than changes resulting from the Companys stock for the three months ended September 30, 2006
and 2005, was $971.4 million and $1,466.0 million, respectively. Comprehensive income for the
nine months ended September 30, 2006 and 2005 was $3,957.7 million and $3,607.9 million,
respectively. |
|
13. |
|
Segment Reporting |
|
|
|
The Companys operations are principally managed on a products basis. The Merck Pharmaceutical
segment includes products marketed either directly or through joint ventures. These products
consist of therapeutic and preventive agents, sold by prescription, for the treatment of human
disorders. Other segment revenues include non-reportable human and animal health segments. |
- 19 -
Notes to Consolidated Financial Statements (continued)
Revenues and profits for these segments are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Segment revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Merck Pharmaceutical |
|
$ |
4,764.3 |
|
|
$ |
5,054.6 |
|
|
$ |
15,173.8 |
|
|
$ |
15,293.1 |
|
Other segment revenues |
|
|
562.9 |
|
|
|
351.8 |
|
|
|
1,189.4 |
|
|
|
845.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,327.2 |
|
|
$ |
5,406.4 |
|
|
$ |
16,363.2 |
|
|
$ |
16,138.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment profits: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Merck Pharmaceutical |
|
$ |
3,222.3 |
|
|
$ |
3,266.1 |
|
|
$ |
10,479.9 |
|
|
$ |
9,663.4 |
|
Other segment profits |
|
|
381.6 |
|
|
|
378.9 |
|
|
|
887.1 |
|
|
|
883.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,603.9 |
|
|
$ |
3,645.0 |
|
|
$ |
11,367.0 |
|
|
$ |
10,546.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A reconciliation of total segment revenues to consolidated sales is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Segment revenues |
|
$ |
5,327.2 |
|
|
$ |
5,406.4 |
|
|
$ |
16,363.2 |
|
|
$ |
16,138.5 |
|
Other revenues |
|
|
83.2 |
|
|
|
9.8 |
|
|
|
228.7 |
|
|
|
107.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,410.4 |
|
|
$ |
5,416.2 |
|
|
$ |
16,591.9 |
|
|
$ |
16,246.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenues are primarily comprised of miscellaneous corporate revenues, sales related to
divested products or businesses and other supply sales.
Sales (1) of the Companys products were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Singulair |
|
$ |
868.0 |
|
|
$ |
692.5 |
|
|
$ |
2,619.1 |
|
|
$ |
2,157.0 |
|
Zocor |
|
|
371.0 |
|
|
|
1,049.9 |
|
|
|
2,424.1 |
|
|
|
3,307.4 |
|
Fosamax |
|
|
770.5 |
|
|
|
777.3 |
|
|
|
2,345.0 |
|
|
|
2,401.9 |
|
Cozaar/Hyzaar |
|
|
813.3 |
|
|
|
751.4 |
|
|
|
2,298.1 |
|
|
|
2,255.1 |
|
Primaxin |
|
|
181.8 |
|
|
|
181.9 |
|
|
|
523.6 |
|
|
|
548.1 |
|
Cosopt/Trusopt |
|
|
190.9 |
|
|
|
156.3 |
|
|
|
517.8 |
|
|
|
449.7 |
|
Proscar |
|
|
127.3 |
|
|
|
185.9 |
|
|
|
498.5 |
|
|
|
549.1 |
|
Vasotec/Vaseretic |
|
|
134.5 |
|
|
|
149.2 |
|
|
|
410.8 |
|
|
|
471.3 |
|
Cancidas |
|
|
127.1 |
|
|
|
142.3 |
|
|
|
397.1 |
|
|
|
412.5 |
|
Maxalt |
|
|
105.1 |
|
|
|
92.3 |
|
|
|
295.2 |
|
|
|
254.2 |
|
Propecia |
|
|
88.9 |
|
|
|
66.9 |
|
|
|
249.0 |
|
|
|
205.8 |
|
Vaccines/Biologicals |
|
|
555.4 |
|
|
|
338.4 |
|
|
|
1,176.1 |
|
|
|
809.5 |
|
Other |
|
|
1,076.6 |
|
|
|
831.9 |
|
|
|
2,837.5 |
|
|
|
2,424.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,410.4 |
|
|
$ |
5,416.2 |
|
|
$ |
16,591.9 |
|
|
$ |
16,246.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Presented net of discounts and returns. |
- 20 -
Notes to Consolidated Financial Statements (continued)
Other primarily includes sales of other human pharmaceuticals, pharmaceutical and animal
health supply sales to the Companys joint ventures and revenue from the Companys
relationship with AstraZeneca LP primarily relating to sales of Nexium and Prilosec.
A reconciliation of segment profits to Income Before Taxes is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions) |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Segment profits |
|
$ |
3,603.9 |
|
|
$ |
3,645.0 |
|
|
$ |
11,367.0 |
|
|
$ |
10,546.9 |
|
Other profits |
|
|
56.9 |
|
|
|
17.3 |
|
|
|
163.0 |
|
|
|
129.4 |
|
Adjustments |
|
|
110.4 |
|
|
|
170.1 |
|
|
|
375.6 |
|
|
|
419.9 |
|
Unallocated: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
195.0 |
|
|
|
122.3 |
|
|
|
564.6 |
|
|
|
314.8 |
|
Interest expense |
|
|
(87.7 |
) |
|
|
(99.6 |
) |
|
|
(277.8 |
) |
|
|
(277.2 |
) |
Equity income from affiliates |
|
|
37.7 |
|
|
|
68.0 |
|
|
|
175.6 |
|
|
|
141.7 |
|
Depreciation and amortization |
|
|
(521.5 |
) |
|
|
(386.3 |
) |
|
|
(1,599.9 |
) |
|
|
(1,086.3 |
) |
Research and development |
|
|
(945.4 |
) |
|
|
(942.6 |
) |
|
|
(3,059.9 |
) |
|
|
(2,736.0 |
) |
Other expenses, net |
|
|
(1,218.5 |
) |
|
|
(595.8 |
) |
|
|
(2,398.7 |
) |
|
|
(1,609.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,230.8 |
|
|
$ |
1,998.4 |
|
|
$ |
5,309.5 |
|
|
$ |
5,844.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment profits are comprised of segment revenues less certain elements of materials and
production costs and operating expenses, including components of equity income from affiliates
and depreciation and amortization expenses. For internal management reporting presented to the
chief operating decision maker, the Company does not allocate the vast majority of indirect
production costs, research and development expenses and general and administrative expenses, as
well as the cost of financing these activities. Separate divisions maintain responsibility for
monitoring and managing these costs, including depreciation related to fixed assets utilized by
these divisions and, therefore, they are not included in segment profits.
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.
- 21 -
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
Acquisitions
On October 30, 2006, Merck and Sirna Therapeutics, Inc. (Sirna) announced they had entered into a
definitive agreement under which Merck will acquire through a merger 100% of the equity of Sirna
for $13 per share in cash. The transaction has a cash value of approximately $1.1 billion.
Sirna is a publicly held biotechnology company that is a leader in developing a new class of
medicines based on RNA interference (RNAi) technology, which could significantly alter the
treatment of disease. RNAi-based therapeutics selectively catalyze the destruction of the RNA
transcribed from an individual gene. The acquisition is subject to clearance under the
Hart-Scott-Rodino Antitrust Improvements Act and approval by the stockholders of Sirna and other
customary closing conditions. The companies expect to complete the acquisition in the first
quarter of 2007.
In May 2006, Merck acquired Abmaxis, Inc. (Abmaxis), a privately-held biopharmaceutical company
dedicated to the discovery and optimization of monoclonal antibody (MAb) products for human
therapeutics and diagnostics, for $80 million in cash. In June 2006, Merck acquired GlycoFi,
Inc. (GlycoFi), a privately-held biotechnology company that was a leader in the field of yeast
glycoengineering, that is the addition of specific carbohydrate modifications to the proteins in
yeast, and optimization of biologic drug molecules, for $373 million in cash ($400 million
purchase price net of $25 million of shares already owned and net transaction costs). The Company
recorded a $296.3 million charge for acquired research in connection with the acquisition which
is not deductible for tax purposes. While each of the acquisitions has independent scientific
merits, the combination of the GlycoFi and Abmaxis platforms is potentially synergistic, giving
Merck the ability to operate across the entire spectrum of therapeutic antibody discovery,
development and commercialization (see Note 4).
Global Restructuring Program
In November 2005, the Company commenced the initial phase of its global restructuring program
designed to reduce the Companys cost structure, increase efficiency, and enhance
competitiveness. As part of this program, Merck plans to sell or close five manufacturing sites
and two preclinical sites by the end of 2008, and eliminate approximately 7,000 positions
company-wide. To date, manufacturing operations have ceased at one site, one other site has been
sold, and the two preclinical sites have been closed. The Company has also sold certain other
facilities and related assets in connection with the restructuring program. There have been
approximately 3,900 positions eliminated throughout the Company since inception of the program
(approximately 2,800 of which were eliminated during the nine months ended September 30, 2006).
Through the end of 2008, when the initial phase of the global restructuring program is expected
to be substantially complete, the cumulative pre-tax costs are expected to range from $1.8
billion to $2.2 billion. The Company expects to record charges of approximately $900 million to
$1 billion during 2006, based on estimated time of completion, as the sales/closures of the
facilities occur. Cumulative pre-tax savings are expected to be $4.5 to $5.0 billion from 2006
through 2010. The Company recorded pre-tax restructuring costs of $249.2 million ($165.9 million
after tax or $0.08 per share) and $714.0 million ($463.3 after tax or $0.21 per share) for the
three and nine months ended September 30, 2006, respectively. These costs related primarily to
the global restructuring program which was comprised primarily of accelerated depreciation and
separation costs, partially offset by gains on sales of facilities in connection with this
restructuring action (see Note 2).
Share-Based Compensation
Effective January 1, 2006, the Company adopted Financial Accounting Standards No. 123R,
Share-Based Payments (FAS 123R). Employee stock option expense was previously recognized using
the intrinsic value method which measures share-based compensation expense as the amount at which
the market price of the stock at the date of grant exceeds the exercise price. FAS 123R requires
the recognition of the fair value of share-based compensation in net income, which the Company
will recognize on a straight-line basis over the requisite service period. Additionally, the
Company elected the modified prospective transition method for adopting FAS 123R, and therefore,
prior periods were not restated. Under this method, the provisions for FAS 123R apply to all
awards granted or modified after January 1, 2006. In addition, the unrecognized expense of awards
that have not yet vested at the date of adoption shall be recognized in net income in the periods
after the date of adoption. The Company recorded share-based compensation cost in the amount of
$63.7 million and $246.0 million for the three and nine months ended September 30, 2006,
respectively, of which $42.3 million and $182.8 million, respectively, was incremental due to the
adoption of FAS 123R (see Note 3). Incremental share-based compensation expense for full year
2006 is expected to be approximately $220 million.
At September 30, 2006, there was $374.9 million of total pre-tax unrecognized compensation
expense related to nonvested awards which will be recognized over a weighted average period of
2.3 years. For segment reporting, share-based compensation expense is recorded in unallocated
expense.
- 22 -
American Jobs Creation Act of 2004 Repatriation
As previously disclosed, in October 2004, the American Jobs Creation Act of 2004 (the AJCA) was
signed into law. The AJCA created temporary incentives for U.S. multinationals to repatriate
accumulated income earned outside the United States as of December 31, 2002. In accordance with
the AJCA, the Company recorded an income tax charge of $740 million in Taxes on income in the
second quarter of 2005 related to the $15.9 billion repatriated during 2005. This charge was
partially offset by a $100 million benefit in connection with a decision to implement certain tax
planning strategies. The Company has not changed its intention to indefinitely reinvest
accumulated earnings earned subsequent to December 31, 2002. No provision will be made for
income taxes that would be payable upon the distributions of such earnings and it is not
practicable to determine the amount of the related unrecognized deferred income tax liability.
In addition, the Company has subsidiaries operating in Puerto Rico and Singapore under tax
incentive grants that expire in 2015 and 2026, respectively.
Operating Results
Summary
Earnings per share assuming dilution (EPS) for the three and nine months ended September 30, 2006
were $0.43 and $1.81, respectively, compared with $0.65 and $1.59 for the three and nine months
ended September 30, 2005, respectively. Net income for the three and nine months ended September
30, 2006 was $940.6 million and $3.96 billion, respectively, compared with $1.42 billion and
$3.51 billion for the three and nine months ended September 30, 2005, respectively.
EPS and Net income for the three and nine months ended September 30, 2006 were negatively
affected by an additional reserve solely for future Vioxx legal defense costs, charges related to
the global restructuring program, as well as the impact of adopting FAS 123R. Additionally, EPS
and Net income for the nine months ended September 30, 2006 were negatively impacted by the
acquired research charge related to the GlycoFi acquisition in the second quarter of 2006. EPS
and Net income for the nine months ended September 30, 2005 were negatively impacted by the net
tax charge primarily related to the repatriation of foreign earnings in accordance with the AJCA.
Worldwide sales were $5.41 billion for the third quarter of 2006, compared with $5.42 billion for
the third quarter of 2005. Global sales performance included a 1% volume increase, 1% favorable
effect from foreign exchange, and a 2% unfavorable effect from price changes for the quarter.
Worldwide sales were $16.59 billion for the first nine months of 2006, compared with $16.25
billion for the first nine months of 2005, representing an increase of 2%. Global sales
performance for the first nine months of 2006 included a 2% volume increase, a 1% favorable
effect from price changes, and a 1% unfavorable effect from foreign exchange.
Materials and production costs were $1.54 billion for the third quarter of 2006, an increase of
25% from the third quarter of 2005, including $199.6 million recorded in the current quarter
primarily for accelerated depreciation and asset impairment costs associated with the global
restructuring program. The increase also reflects $4.5 million related to the expensing of stock
options. For the nine months ended September 30, 2006, Materials and production costs were $4.33
billion, which includes the impact of $572.1 million in restructuring costs and $19.7 million
related to the expensing of stock options.
The gross margin was 71.5% in the third quarter of 2006 compared with 77.1% in the third quarter
of 2005. The 2006 gross margin reflects a 3.7 percentage point unfavorable impact relating to the
costs associated with the global restructuring program. Changes in the product mix also had an
unfavorable impact for the third quarter of 2006. For the first nine months of 2006, the gross
margin was 73.9%, including a 3.4 percentage point unfavorable impact relating to the costs
associated with the global restructuring program, compared with 77.4% for the comparable prior
year period.
Marketing and administrative expenses were $2.37 billion, an increase of 43% in the third quarter
of 2006. Marketing and administrative expenses includes an additional $598 million reserve
solely for future legal defense costs for Vioxx litigation, as well as the impact of $25.3
million related to the expensing of stock options. For the nine months ended September 30, 2006,
Marketing and administrative expenses increased 16%, which includes the impact of the additional
reserve solely for future legal defense costs for Vioxx litigation, as well as the impact of
$113.2 million related to the expensing of stock options. The results also reflect the increase
in the level of activity to support three recently-approved vaccines and the launch of Januvia in
the United States.
Research and development expenses totaling $945.4 million for the third quarter of 2006 were
comparable to the third quarter of 2005 and included $11.1 million for the expensing of stock
options. For the nine months ended September 30, 2006, Research and development expenses
increased 12%, which reflected the $296.3 million acquired research charge associated with the
GlycoFi acquisition, $55.4 million related to the global restructuring program, and the impact of
$46.6 million related to the expensing of stock options.
- 23 -
Restructuring costs were $49.6 million for the quarter, representing separation and other related
costs associated with the global restructuring program. For the nine months ended September 30,
2006, Restructuring costs were $86.5 million and included the impact of gains on the sales of
facilities in connection with the program (see Note 2).
Equity income from affiliates for the three and nine months ended September 30, 2006 was $595.4
million and $1.71 billion, respectively, compared with $480.1 million and $1.13 billion for the
three and nine months ended September 30, 2005, respectively. The increases in 2006 primarily
reflect the successful performance of Zetia and Vytorin through the Merck/Schering-Plough
partnership and the higher year-to-date partnership returns from AstraZeneca LP (AZLP).
The change in Other (income) expense, net for the three and nine months ended September 30, 2006
as compared with the same periods of 2005 primarily reflects an increase in interest income
generated from the Companys investment portfolio derived from higher interest rates and higher
average investment portfolio balances.
The effective tax rate was 23.6% for the third quarter of 2006 and 28.9% for the third quarter of
2005. The effective tax rate was 25.4% and 39.9% for the first nine months of 2006 and 2005,
respectively. The 2006 effective tax rate reflects the impact of the second quarter acquired
research charge, the third quarter additional reserve solely for future Vioxx legal defense
costs, as well as costs associated with the global restructuring program. The 2005 effective tax
rate reflects the net tax charge primarily related to the AJCA.
Sales
Sales of the Companys products were as follows:
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($ in millions) |
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Three Months |
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Nine Months |
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Ended September 30, |
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Ended September 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Singulair |
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$ |
868.0 |
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$ |
692.5 |
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$ |
2,619.1 |
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$ |
2,157.0 |
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Zocor |
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371.0 |
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1,049.9 |
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2,424.1 |
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3,307.4 |
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Fosamax |
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770.5 |
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777.3 |
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2,345.0 |
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2,401.9 |
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Cozaar/Hyzaar |
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813.3 |
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751.4 |
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2,298.1 |
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2,255.1 |
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Primaxin |
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181.8 |
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181.9 |
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523.6 |
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548.1 |
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Cosopt/Trusopt |
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190.9 |
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156.3 |
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517.8 |
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449.7 |
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Proscar |
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127.3 |
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185.9 |
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498.5 |
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549.1 |
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Vasotec/Vaseretic |
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134.5 |
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149.2 |
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410.8 |
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471.3 |
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Cancidas |
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127.1 |
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142.3 |
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397.1 |
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412.5 |
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Maxalt |
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105.1 |
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92.3 |
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295.2 |
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254.2 |
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Propecia |
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88.9 |
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66.9 |
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249.0 |
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205.8 |
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Vaccines/Biologicals |
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555.4 |
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338.4 |
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1,176.1 |
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809.5 |
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Other |
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1,076.6 |
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831.9 |
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2,837.5 |
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2,424.4 |
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$ |
5,410.4 |
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$ |
5,416.2 |
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$ |
16,591.9 |
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$ |
16,246.0 |
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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 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) 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 $656.8 million and $1,245.7 million for the three months ended September 30, 2006 and
2005, respectively, and by $2,909.2 million and $3,406.7 million for the nine months ended
September 30, 2006 and 2005, respectively. Other primarily includes sales of other human
pharmaceuticals, pharmaceutical and animal health supply sales to the Companys joint ventures
and revenue from the Companys relationship with AZLP. Inventory levels at key wholesalers for
each of the Companys major products are generally less than one month.
Worldwide sales were strong for Singulair, a once-a-day oral medicine indicated for the chronic
treatment of asthma and the relief of symptoms of allergic rhinitis, reaching $868.0 million for
the third quarter of 2006, representing growth of
25% over the third quarter of 2005. Sales for the first nine months of 2006 were $2.62 billion,
a 21% increase over the comparable 2005 period. Singulair continues to be the number one
prescribed product in the U.S. respiratory market.
- 24 -
Global sales of Mercks antihypertensive medicines, Cozaar and Hyzaar*, were $813.3 million for
the third quarter of 2006, representing an increase of 8% from the third quarter of 2005. Sales
for the first nine months of 2006 were $2.30 billion, a 2% increase compared with the first nine
months of 2005.
Global sales for Fosamax and Fosamax Plus D (marketed as Fosavance throughout the European Union
(EU)) were $770.5 million for the third quarter of 2006, representing a decrease of 1% compared
to the third quarter of 2005. U.S. sales for the quarter increased 7%. Sales outside the United
States were affected by the availability of other alendronate sodium products in several key
markets. Global sales for the first nine months were $2.34 billion, a 2% decrease over the
comparable 2005 period. Fosamax and Fosamax Plus D together remain the most prescribed medicine
worldwide for the treatment of postmenopausal, male and glucocorticoid-induced osteoporosis.
In August 2006, Fosamax (marketed as Fosamac) became the first once-weekly, oral medicine for
osteoporosis to be launched in Japan, the second largest pharmaceutical market in the world and
home to approximately 10 million women with the disease.
In September 2006, Merck presented data from two studies at the 28th Annual Meeting of the
American Society for Bone Mineral Research (ASBMR) which showed that higher persistency rates
were seen among osteoporosis patients taking Fosamax Once Weekly (alendronate) therapies than
were seen among patients taking ibandronate once monthly or once weekly risedronate therapies.
The data were based on studies conducted by the Company comparing the persistency rates of weekly
versus monthly oral bisphosphonate dosing frequency. Both studies were based on a review of two
prescription drug databases containing prescription records from a total of over 300,000 patients
in the United States.
Zocor, Mercks statin for modifying cholesterol, achieved worldwide sales of $371.0 million in
the third quarter of 2006, representing a decrease of 65% over the third quarter of 2005. Sales
for the first nine months of 2006 were $2.42 billion, a 27% decrease compared with the first nine
months of 2005. Mercks U.S. marketing exclusivity for Zocor expired on June 23, 2006.
The Companys previously signed authorized generic agreement with Dr. Reddys Laboratories went
into effect subsequent to the Zocor patent expiration in the United States. During the third
quarter of 2006, Merck recorded $82.0 million in Other revenue associated with the Dr. Reddys
arrangement for simvastatin. Merck continues to offer branded Zocor and to manufacture
simvastatin for branded Zocor, Vytorin, the Companys investigational compound MK-0524B and Dr.
Reddys authorized generic.
Total sales of Mercks other promoted medicines and vaccines were $1.79 billion for the third
quarter of 2006, representing growth of 15% as compared with the third quarter of 2005. Sales
for the first nine months of 2006 were $4.85 billion compared with $4.42 billion for the same
period of 2005. These products treat or prevent a broad range of medical conditions, including
glaucoma, migraine, and pain in addition to infectious disease, cervical cancer, rotavirus
disease and shingles.
Vaccine sales were $555.4 million for the third quarter of 2006, representing strong growth of
64%. Sales of vaccines for the first nine months of 2006 were $1.18 billion compared with $809.5
million for the comparable period of 2005. The results benefited from the launch of three new
vaccines, RotaTeq, Zostavax and Gardasil, and the strong performance of ProQuad.
Total sales for Gardasil, Mercks vaccine to prevent cervical cancer and vulvar and vaginal
pre-cancers caused by human papillomavirus (HPV) types 16 and 18 and to prevent low-grade and
pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18, were $70.0 million
for the third quarter of 2006. Managed care plans representing more
than 90% of covered lives of
girls and women aged 9-26 have added Gardasil to their respective formularies. On November 1,
2006, the Company announced that the U.S. Centers for Disease Control and Protection (CDC) added
Gardasil to the CDCs Vaccines for Children contract for girls and women aged 9 to 18.
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* |
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COZAAR and HYZAAR are registered trademarks of E.I. DuPont de Nemours & Company,
Wilmington, Delaware. |
- 25 -
In late September 2006, Gardasil was approved as the first and only vaccine in the EU for
use in children and adolescents aged 9 to 15 years and in adult females aged 16 to 26 years for
the prevention of cervical cancer, high-grade cervical dysplasias/precancers [cervical
intraepithelial neoplasia (CIN 2/3)], high-grade/precancerous vulvar dysplastic lesions (VIN 2/3)
and external genital warts (condyloma acuminata) caused by HPV types 6, 11, 16 and 18. Gardasil
will be marketed by Sanofi Pasteur MSD, a joint venture between Sanofi Pasteur and Merck & Co.,
Inc., in 19 European countries, including 15 in the EU. In the remaining Central and Eastern
European countries, Gardasil will be marketed by Merck Sharp & Dohme as either Gardasil or
Silgard.
Clinical studies to evaluate the efficacy of Gardasil in females 27-45 years of age and males
16-26 years of age continue in more than 30 countries around the world. Merck is also conducting
ongoing clinical studies to assess the potential for cross-protection against HPV types related
to HPV 16 and 18, including HPV 31 and 45. Cross-protection, if proven, could potentially expand
the vaccines prevention coverage against cervical cancer.
RotaTeq, Mercks vaccine to help protect children against rotavirus gastroenteritis, achieved
total sales of $61.8 million for the third quarter of 2006. Within the United States, health
insurance plans representing more than 80% of covered lives in the eligible age group of infants
and young children between six and 32 weeks of age have added RotaTeq to their formularies.
Applications for licensure of RotaTeq have been filed in more than 100 countries. In Nicaragua,
where RotaTeq was recently approved, Merck will provide the vaccine free for all infants born in
the country over a three-year period through a joint demonstration project with the Nicaraguan
Ministry of Health.
On October 25, 2006, the Company announced that the U.S. Centers for Disease Control and
Preventions Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend
that adults 60 years of age and older be vaccinated with Zostavax (Zoster Vaccine Live
(Oka/Merck)) to help prevent shingles (herpes zoster), a frequently painful disease marked by a
blistering rash. Zostavax was approved by the U.S. Food and Drug Administration (FDA) on May 25,
2006 for the prevention of shingles in individuals 60 years of age and older. Zostavax is not a
treatment for shingles or postherpetic neuralgia (long-term nerve pain that can be a complication
of shingles).
Merck earns ongoing revenue based on sales of products that are associated with its alliances,
the most significant of which is AstraZeneca LP. Revenue from AstraZeneca LP recorded by Merck
was $442.5 million in the third quarter of 2006 and $1.24 billion for the first nine months of
2006, which were comparable to the corresponding prior year periods.
Combined global sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough partnership,
were $1.03 billion for the third quarter of 2006 and were $2.80 billion for the first nine months
of 2006.
Global sales of Zetia, the cholesterol-absorption inhibitor also marketed as Ezetrol outside the
United States, reached $501.9 million in the third quarter of 2006, an increase of 41% compared
with the third quarter of 2005. Sales for the first nine months of 2006 were $1.39 billion, an
increase of 39% over the comparable 2005 period.
Global sales of Vytorin, marketed outside the United States as Inegy, reached $526.6 million in
the third quarter of 2006. Sales for the first nine months of 2006 were $1.40 billion. On
October 5, 2006, the Merck/Schering-Plough partnership announced that the FDA had approved the
inclusion of new data in the product label showing that Vytorin, a cholesterol-absorption
inhibitor combined with simvastatin, is more effective than Crestor at lowering LDL cholesterol
at all compared doses, ranging from the usual starting recommended doses (Vytorin 10/20 mg,
Crestor 10 mg) to the maximum approved doses (Vytorin 10/80 mg, Crestor 40 mg). Vytorin now has
been shown in clinical studies to provide greater LDL cholesterol lowering efficacy versus
Lipitor, Crestor and Zocor at all study dose comparisons.
The Company records the results from its interest in the Merck/Schering-Plough partnership in
Equity income from affiliates.
Research and Development
On October 16, 2006, Januvia was approved by the FDA, and is now the first and only dipeptidyl
peptidase-4 (DPP-4) inhibitor available in the United States for the treatment of type 2
diabetes. DPP-4 inhibitors represent a new 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. Januvia has been approved as monotherapy and as add-on therapy to either of two
other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve
blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise are not
enough.
Clinical studies show that Januvia provides significant A1C (a measure of average blood glucose
level over a two- to three-month period) reductions in both monotherapy and when added to
commonly used diabetes drugs such as metformin and TZDs. Treatment with Januvia was not
associated with weight gain or an increased risk of
- 26 -
hypoglycemia. The recommended dose of Januvia is 100 mg once daily. Januvia has already
launched in Mexico, and other regulatory filings around the world are moving ahead as planned.
Januvia also is being investigated as part of a single tablet combination with metformin, known
as MK-0431A. The FDA has accepted Mercks filing for standard review, and FDA action is
anticipated by the end of March 2007.
On October 6, 2006, Merck announced that the FDA had approved Zolinza for the treatment of
cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive,
persistent or recurrent disease on or following two systemic therapies. The approval of Zolinza
represents the first anticancer treatment approved for CTCL since 1999.
Merck presented interim 24-week data on MK-0518, the Companys investigational HIV integrase
inhibitor, from the Phase II dose-ranging study in previously untreated patients at the 16th International AIDS Conference in
August 2006. The data showed that MK-0518 twice daily, when used in combination with tenofovir
and lamivudine, achieved a comparable viral load reduction to efavirenz combined with the same
agents.
At the American Society for Microbiologys 46th Annual International Conference on Antimicrobial
Agents and Chemotherapy in September 2006, Merck presented
additional analyses from this study that demonstrated no increase in
lipid levels in treatment-naive patients taking MK-0518 with
tenofovir and lamivudine. Also presented at the conference were the interim 24-week data from
another ongoing study that showed MK-0518 maintaining viral load regression in treatment-experienced
patients who failed antiretroviral therapy and who were resistant to drugs in all three classes
of oral antiretroviral drugs.
On September 29, 2006, Merck announced it will not file a worldwide marketing application in 2007
for MK-0524B, its investigational fixed-dose combination of MK-0524A (a DP-1 selective inhibitor
coupled with extended-release niacin) and simvastatin, because of an unresolved formulation
issue. A new filing date has not been determined. Phase III clinical studies supporting
MK-0524B continue with MK-0524A co-administered with simvastatin. In addition, the clinical
development program for MK-0524A remains on track, and the Company plans to file MK-0524A with
the FDA in 2007.
On October 13, 2006, Merck and H. Lundbeck A/S of Denmark announced that the submission of a New
Drug Application (NDA) for gaboxadol with the FDA will no longer occur in the first quarter of
2007. The companies plan to submit the application to the FDA in mid-2007. The delay in the NDA
submission for gaboxadol, a novel investigational drug in Phase III development for the treatment
of insomnia, resulted from slower than anticipated enrollment in ongoing trials.
Merck has initiated a targeted Phase III program with its investigational compound for the
treatment of obesity, MK-0364, which is an investigational cannabinoid-1 receptor (CB1R) inverse
agonist. The Company is not in a position at this time to provide a potential product profile or
a filing date.
Merck continues its strategy of establishing strong external alliances to complement our
substantial internal research capabilities, including research collaborations, licensing
pre-clinical and clinical compounds and technology transfers to drive both near- and long-term
growth. Through the third quarter of 2006, Merck has entered into 24 such transactions.
On October 12, 2006, Merck and Ambrilia Biopharma Inc. (Ambrilia), a biopharmaceutical company
developing innovative therapeutics in the fields of cancer and infectious diseases, announced
they entered into an exclusive licensing agreement granting Merck the worldwide rights to
Ambrilias HIV/AIDS protease inhibitor program. Under the terms of the agreement, Ambrilia
granted Merck the exclusive worldwide rights to its lead compound, PPL-100, which has completed a
Phase I single-dose pharmacokinetic study and is currently in a Phase I repeat dose
pharmacokinetic study. In return, Ambrilia received an upfront licensing fee of $17 million on
signing and is eligible for cash payments totaling up to $215 million upon successful completion
of development, clinical, regulatory and sales milestones. Ambrilia will receive royalties on all
future product sales.
On September 27, 2006, the Company announced that it will expand the scope of its existing
strategic collaboration with FoxHollow Technologies, Inc. (FoxHollow) for atherosclerotic plaque
analysis and that Merck will acquire a stake in FoxHollow with the purchase of $95 million in
common stock, subject to customary closing conditions and clearance under the Hart-Scott-Rodino
Antitrust Improvements Act. Merck will acquire newly-issued shares of FoxHollow common stock at
$29.629 per share, representing approximately an 11% stake. Under the terms of the expanded
collaboration agreement, Merck will pay $40 million to FoxHollow over four years in exchange for
FoxHollows agreement to collaborate exclusively with Merck in specified disease areas. Merck
will also provide a minimum of $60 million in funding to FoxHollow over the first three years of
the four year collaboration program term, for research activities to be conducted by FoxHollow
under Mercks direction. FoxHollow will receive milestone payments on successful
- 27 -
development of drug products or diagnostic tests utilizing results from the collaboration, as
well as royalties. This transaction is expected to close in the fourth quarter of 2006.
On August 11, 2006, Merck and Gilead Sciences, Inc. established an agreement for the distribution
of Atripla, a once-daily, single tablet regimen for the treatment of HIV-1 infection in adults,
in developing countries around the world. Atripla contains 600 mg of efavirenz, a non-nucleoside
reverse transcriptase inhibitor, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil
fumarate, both nucleoside reverse transcriptase inhibitors. Efavirenz is marketed by Merck under
the tradename Stocrin in all territories outside of the United States, Canada and certain
European countries (where it is commercialized by Bristol-Myers Squibb under the tradename
Sustiva). Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead Sciences
under the tradenames Emtriva and Viread, respectively. The compounds are commonly prescribed
together as a once-daily, fixed-dose tablet, marketed under the tradename Truvada for use as part
of combination therapy.
On October 9, 2006, Bristol-Myers Squibb Company, Gilead Sciences, Inc. and Merck, announced the
submission of a Marketing Authorisation Application (MAA) for Atripla in the EU to the European
Medicines Agency (EMEA). The MAA will be reviewed by the Committee for Medicinal Products for
Human Use, subject to validation by the EMEA. The MAA for Atripla in the EU was filed jointly by
the three companies through a newly established three-way joint venture based in Ireland,
Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited. Review of the MAA will be
conducted by the EMEA under the centralized licensing procedure, which, when finalized, provides
one marketing authorization in all member states of the EU. Discussions among the three
companies regarding agreements for manufacturing, commercialization and distribution of Atripla
in the EU are ongoing.
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|
|
Liquidity and Capital Resources |
|
|
|
|
|
|
|
|
|
($ in millions) |
|
September 30, 2006 |
|
December 31, 2005 |
|
Cash and investments |
|
$ |
15,530.7 |
|
|
$ |
16,745.5 |
|
Working capital |
|
$ |
4,076.5 |
|
|
$ |
7,806.9 |
|
Total debt to total liabilities and equity |
|
|
13.7 |
% |
|
|
18.1 |
% |
The decrease in working capital primarily reflects a change in the mix of the Companys
investments from short-term to long-term. The decrease in the ratio of total debt to total
liabilities and equity primarily reflects the repayment of commercial paper in the first half of
2006.
Cash provided by operations continues to be the Companys primary source of funds to finance
operating needs and capital expenditures. Net cash provided by operating activities totaled $5.0
billion and $5.3 billion for the nine months ended September 30, 2006 and 2005, respectively.
In 2005, the Company repatriated $15.9 billion in connection with the AJCA and recorded an income
tax charge of $766.5 million ($740.0 million recorded in the second quarter of 2005) related to
this repatriation, $185.0 million of which was paid in the fourth quarter of 2005 and the
remainder was paid in the first quarter of 2006 (see Note 8).
As more fully described in Note 8, the Company is currently addressing certain tax matters with
applicable taxing authorities. While the ultimate resolutions of these matters are not expected
to have material adverse effects on the Companys liquidity or financial condition, any payments
made or deposits paid in conjunction with these matters are likely to have a material adverse
effect on the Companys cash flows in the quarter such payments or deposits are made.
Capital expenditures totaled $684.7 million and $996.1 million for the first nine months of 2006
and 2005, respectively. Capital expenditures for the full year 2006 are expected to approximate
$1.1 billion.
Dividends paid to stockholders were $2.5 billion for the first nine months of both 2006 and 2005.
In May and July 2006, the Board of Directors declared a quarterly dividend of $0.38 cents per
share on the Companys common stock for the third and fourth quarters of 2006, respectively.
The Company purchased $751.0 million of its common stock (20.8 million shares) for its Treasury
during the first nine months of 2006. The Company has approximately $6.8 billion remaining under
the July 2002 treasury stock purchase authorization.
In July 2006, $500 million of 5.25% notes, along with an associated pay-floating, receive-fixed
interest rate swap, matured and were retired.
- 28 -
In April 2006, the Company extended the maturity date of its $1.5 billion, 5-year revolving
credit facility from 2010 to 2011. The facility provides backup liquidity for the Companys
commercial paper borrowing facility and is to be used for general corporate purposes. The
Company has not drawn funding from this facility.
Critical Accounting Policies
The Companys significant accounting policies, which include managements best estimates and
judgments, are included in Note 2 to the consolidated financial statements of the 2005 Annual
Report on Form 10-K for the year ended December 31, 2005. 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 2005 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 123R, as discussed in Note 3,
there have been no significant changes in the Companys critical accounting policies since
December 31, 2005.
Recently Issued Accounting Standards
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement No. 158,
Employers Accounting for Defined Benefit Pension and Other Postretirement Plans, an amendment of
FASB Statements No. 87, 106 and 132R (FAS 158), which is effective December 31, 2006, except for
the requirement to measure plan assets and benefit obligations as of the companys fiscal year-end
balance sheet which is effective as of December 31, 2008. Retrospective application is not
permitted. Among other provisions, FAS 158 requires companies to fully recognize the funded or
unfunded status of their benefit plans as an asset or liability, as well as recognize any
previously unrecognized gains and losses and unrecognized prior service costs as a component of
accumulated other comprehensive income, net of taxes, on the balance sheet. Since the Company
measures plan assets and obligations on an annual basis, it cannot estimate the impact of FAS 158
in advance of the Companys December 31, 2006 measurement date. If the Company had been required to
adopt the provisions of FAS 158 as of December 31, 2005, the Company estimates that Stockholders
equity would have decreased by approximately 10%. However, the impact of adoption on December 31,
2006 could differ significantly as it will reflect asset performance through the end of 2006 as
well as interest rates and other factors which are applicable as of December 31, 2006. The
adoption of FAS 158 is not expected to impact the Companys results of operations and cash flows,
or any of the Companys financial agreements or covenants.
Also in September 2006, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin No. 108, Considering the Effects of Prior Year Misstatements when Quantifying
Misstatements in Current Year Financial Statements (SAB 108), which will be effective for the
year ended December 31, 2006. The objective of SAB 108 is to eliminate diversity in practice
surrounding how public companies quantify financial statement misstatements. SAB 108 requires
quantification of financial statement misstatements based on the effects of the misstatements on
the consolidated statement of income and the consolidated balance sheet and related financial
statement disclosures. The adoption of SAB 108 is not expected to have an impact on Mercks
financial position or results of operations.
Additionally in September 2006, the FASB issued Statement No. 157, Fair Value Measurements (FAS
157), which will be effective January 1, 2008. This Statement clarifies the definition of fair
value, establishes a framework for measuring fair value, and expands the disclosures on fair
value measurements. The effect of adoption of FAS 157 on the Companys financial position and
results of operations is not expected to be material.
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxesan interpretation of FASB Statement No. 109 (FIN 48), which is effective January 1, 2007.
FIN 48 clarifies the accounting for the uncertainty in tax positions by requiring companies to
recognize in their financial statements, the impact of a tax position, if that position is more
likely than not of being sustained on audit based on the technical merits of the position. Among
other provisions, FIN 48 also requires expanded disclosures at the end of each annual period
presented. The adoption of FIN 48 may result in the cumulative effect of the change in accounting
principle recorded as an adjustment to opening retained earnings. The effect of adoption of FIN
48 on the Companys financial position and results of operations has not yet been determined.
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 Note 7 to
the consolidated financial statements of this report and the Companys 2005 Annual Report on Form
10-K for the year ended December 31, 2005, and the Companys Form 10-Q for the quarters ended
March 31, 2006 and June 30, 2006.
- 29 -
Vioxx Litigation
Product Liability Lawsuits
As previously disclosed, federal and state product liability lawsuits involving individual
claims, as well as putative class actions, have been filed against the Company with respect to
Vioxx. As of October 9, 2006, the Company had been served or was aware that it had been named as
a defendant in approximately 23,800 lawsuits filed on or before September 30, which include
approximately 41,750 plaintiff groups, alleging personal injuries resulting from the use of
Vioxx. Of these lawsuits, approximately 7,450 lawsuits representing approximately 21,950
plaintiff groups are or are slated to be in the federal MDL (discussed below) and approximately
13,850 lawsuits representing approximately 13,850 plaintiff groups are included in a coordinated
proceeding in New Jersey Superior Court before Judge Carol E. Higbee. Certain of these lawsuits
include allegations regarding gastrointestinal bleeding, cardiovascular events, thrombotic events
or kidney damage. The Company has also been named as a defendant in approximately 275 putative
class actions alleging personal injuries or seeking (i) medical monitoring as a result of the
putative class members use of Vioxx, (ii) disgorgement of certain profits under common law
unjust enrichment theories, and/or (iii) various remedies under state consumer fraud and fair
business practice statutes, including recovering the cost of Vioxx purchased by individuals and
third-party payors such as union health plans (all of the actions discussed in this paragraph are
collectively referred to as the Vioxx Product Liability Lawsuits). The actions filed in the
state courts of California, Texas, and New Jersey, and in the counties of Philadelphia,
Pennsylvania, and Clark County, Nevada have been transferred to a single state
court in each location for coordinated proceedings.
In addition to the Vioxx Product Liability Lawsuits discussed above, the claims of over 3,000
plaintiff groups have been dismissed to date. Of these, there have been over 1,100 plaintiff
groups whose claims were dismissed with prejudice (i.e., they can not be brought again) either by
plaintiffs themselves or by the courts. Over 2,000 additional plaintiff groups have had their
claims dismissed without prejudice (i.e., they can be brought again).
On February 16, 2005, the Judicial Panel on Multidistrict Litigation (the JPML) transferred all
Vioxx Product Liability Lawsuits pending in federal courts nationwide into one Multidistrict
Litigation (MDL) for coordinated pre-trial proceedings. The MDL has been transferred to the
United States District Court for the Eastern District of Louisiana before District Judge Eldon E.
Fallon.
In July 2005, Judge Fallon indicated that he would schedule for trial a series of cases during
the period November 2005 through 2006, in the following categories: (i) heart attack with short
term use; (ii) heart attack with long term use; (iii) stroke; and (iv) cardiovascular injury
involving a prescription written after April 2002 when the labeling for Vioxx was revised to
include the results of the VIGOR trial. These trials began in November 2005 and the trials that
took place since June 30, 2006 are described in further detail below.
Several Vioxx Product Liability Lawsuits are currently scheduled for trial in the fourth quarter
of 2006. The Company has provided a list of such trials at its
website at www.merck.com which it
will periodically update as appropriate. The Company has included its website address only as an
inactive textual reference and does not intend it to be an active link to its website nor does it
incorporate by reference the information contained therein.
Merck has entered into a tolling agreement (the Tolling Agreement) with the MDL Plaintiffs
Steering Committee that establishes a procedure to halt the running of the statute of limitations
(tolling) as to certain categories of claims allegedly arising from the use of Vioxx by non-New
Jersey citizens. The Tolling Agreement applies to individuals who have not filed lawsuits and
may or may not eventually file lawsuits and only to those claimants who seek to toll claims
alleging injuries resulting from a thrombotic cardiovascular event that results in a myocardial
infarction or ischemic stroke. The Tolling Agreement provides counsel additional time to
evaluate potential claims. The Tolling Agreement requires any tolled claims to be filed in
federal court. As of October 9, 2006, approximately 15,000 claimants had entered into Tolling
Agreements on or before September 30, 2006.
The Company has previously disclosed the outcomes of several Vioxx Product Liability Lawsuits
that were tried prior to June 30, 2006.
In July 2006, in Doherty v. Merck, in Superior Court of New Jersey, Law Division, Atlantic
County, a jury returned a verdict in favor of the Company on all counts. The jury rejected a
claim by the plaintiff that her nearly three years of Vioxx use caused her heart attack. The
jury also found in Mercks favor on the plaintiffs consumer fraud claim.
In August 2006, in the first case to go to trial in the California coordinated proceeding,
Grossberg v. Merck, the jury in Los Angeles, California returned a verdict for Merck on all
counts.
- 30 -
In August 2006, in Barnett v. Merck, a case before Judge Fallon in the MDL, a jury in New
Orleans, Louisiana returned a plaintiff verdict in the second federal
Vioxx case to go to trial.
The jury awarded $50 million in compensatory damages and $1 million in punitive damages. On
August 30, 2006, Judge Fallon overturned as excessive the damages portion of the verdict and
ordered a new trial on damages. The Company is seeking a new trial on all issues.
On September 26, 2006, in Smith v. Merck, the third case to go to trial in the federal MDL, a
jury returned a verdict in favor of Merck on all counts.
The Company previously disclosed that in April 2006, in Garza v. Merck, a jury in Rio Grande
City, Texas returned a verdict in favor of the plaintiff. In September 2006, the Texas state
court granted the Companys request to investigate possible jury bias because a juror admitted
that he had, prior to the trial, on several occasions borrowed money from the plaintiff.
In August 2006, Judge Fallon granted the Companys motion to dismiss two Vioxx class action
claims previously filed in the federal court; one claim filed by plaintiffs from France and the
other claim by plaintiffs from Italy.
In August 2006, Judge Higbee set aside the November 2005 jury verdict in favor of Merck in
Humeston v. Merck and ordered a new trial on the grounds of newly discovered evidence. The
Company has filed a motion for reconsideration of Judge Higbees decision to re-try the case.
On September 19, 2006, Merck filed a notice of appeal of the previously disclosed August 2005
jury verdict in favor of the plaintiff in the Texas state court case, Ernst v. Merck. Among
several independent grounds for reversal, the Company will argue that there was insufficient
evidence that Mr. Ernst suffered an injury due to Vioxx and that it was improper to allow
testimony by a previously undisclosed witness midway through the trial. In the interim, as
required under Texas law, the Company has posted an appeal bond.
On September 28, 2006, the New Jersey Superior Court, Appellate Division, heard argument on
plaintiffs appeal of Judge Higbees dismissal of the Sinclair v. Merck case. This putative
class action was originally filed in December 2004 and sought the creation of a medical
monitoring fund. Judge Higbee had granted the Companys motion to dismiss in May 2005.
On October 5, 2006, Judge Higbee dismissed the United Kingdom plaintiffs from the New Jersey
Coordinated Proceeding.
The first case scheduled for trial in the Texas coordinated proceeding, Rigby v. Merck, was
scheduled to begin trial on November 7, 2006. The Rigby case was voluntarily dismissed on
October 23, 2006 when the plaintiff filed a non-suit with the Court.
The trial in Mason v. Merck, a case in federal court in Louisiana, started on October 30, 2006.
On October 31, 2006 in California Superior Court in Los Angeles, a consolidated trial began in
the cases Appell v. Merck and Arrigale v. Merck.
The next trial in New Jersey is currently scheduled to start on January 16, 2007, and the Court
has stated that it will be a consolidated trial including multiple plaintiffs. Plaintiffs
proposed eight cases to be joined together for a consolidated trial. Merck filed motions
opposing the concept of a consolidated trial proceeding and challenging the propriety of
plaintiffs proposed cases.
Merck voluntarily withdrew Vioxx from the market on September 30, 2004. Many states have a
two-year statute of limitations for product liability claims, requiring that claims must be filed
within two years after the plaintiffs learned or could have learned of their potential cause of
action. As a result, some may view September 30, 2006 as a deadline for filing Vioxx cases. It
is important to note, however, that the law regarding statutes of limitations can be complex,
varies from state to state, can be fact-specific, and in some cases, might be affected by the
existence of pending class actions. For example, some states have three year statutes of
limitations and, in some instances, the statute of limitations is even longer. Merck expects
that there will be legal arguments concerning the proper application of these statutes, and the
decisions will be up to the judges presiding in individual cases in state and federal
proceedings. As referred to above, as of September 30, 2006, Merck has also entered into
agreements with approximately 15,000 claimants to toll the statute of limitations, so the
September 30, 2006 date would not apply in those instances.
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
seeks recovery of certain Vioxx purchase costs (plus penalties)
- 31 -
based on allegations that the purported class members paid more for Vioxx than they would have
had they known of the products alleged risks. Merck believes that the class was improperly
certified. The trial courts ruling is procedural only; it does not address the merits of
plaintiffs allegations, which the Company intends to defend vigorously. On March 31, 2006, the
New Jersey Superior Court, Appellate Division, affirmed the class certification order. On July
19, 2006, the New Jersey Supreme Court decided to exercise its discretion to hear the Companys
appeal of the Appellate Divisions decision. On August 24, 2006, the Appellate Division ordered a
stay of the proceedings in Superior Court pending a ruling by the Supreme Court.
As previously reported, the Company has also been named as a defendant in separate lawsuits
brought by the Attorneys General of Alaska, Louisiana, Mississippi, Montana, Texas and Utah.
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.
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 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.
Plaintiffs request certification of a class of purchasers of Company stock between May 21, 1999
and October 29, 2004. The complaint alleges 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 seeks unspecified compensatory damages and the costs of suit, including
attorneys fees. The complaint also asserts a claim under Section 20A of the Securities and
Exchange Act against certain defendants relating to their sales of Merck stock. In addition, the
complaint includes allegations under Sections 11, 12 and 15 of the Securities Act of 1933 that
certain defendants made incomplete and misleading statements in a registration statement and
certain prospectuses filed in connection with the Merck Stock Investment Plan, a dividend
reinvestment plan. Defendants have filed a motion to dismiss the complaint, which is pending.
As previously disclosed, on August 15, 2005, a complaint was filed in Oregon state court by the
State of Oregon through the Oregon state treasurer on behalf of the Oregon Public Employee
Retirement Fund against the Company and certain current and former officers and directors. The
complaint, which was brought under Oregon securities law, alleges that plaintiff has suffered
damages in connection with its purchases of Merck common stock at artificially inflated prices
due to the Companys alleged violations of law related to disclosures about Vioxx. The current
and former officers and directors have entered into a tolling agreement and, on June 30, 2006,
were dismissed without prejudice from the case. On July 19, 2006, the Court denied the Companys
motion to dismiss the complaint, but required plaintiff to amend the complaint. Plaintiff filed
an amended complaint on September 21, 2006. Merck intends to file a motion to dismiss the
amended complaint.
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). The consolidated complaint arose out of substantially the same factual
allegations that are made in the Vioxx Securities Lawsuits. The derivative suits, which were
purportedly brought to assert rights of the Company, assert claims against certain members of the
Board past and present and certain executive officers for breach of fiduciary duty, waste of
corporate assets, unjust enrichment, abuse of control and gross mismanagement. On May 5, 2006,
Judge Chesler granted defendants motion to dismiss and denied plaintiffs request for leave to
amend their complaint. Plaintiffs appealed the District Courts decision refusing them leave to
amend to the United States Court of Appeals for the Third Circuit.
As previously disclosed, on October 29, 2004, two individual shareholders made a demand on the
Board of Directors of the Company 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 July 2006,
the Board received another shareholder letter demanding that the Board take legal action against
the Board and management of Merck for allegedly causing damage to the Company relating to the
Companys allegedly improper marketing of Vioxx. These requests remain under consideration.
As previously announced, the Board of Directors appointed a Special Committee to review the
Companys actions prior to its voluntary withdrawal of Vioxx, to act for the Board in responding
to shareholder litigation matters related to the withdrawal of Vioxx, and to advise the Board
with respect to any action that should be taken as a result of the review. In
- 32 -
December 2004, the Special Committee retained the Honorable John S. Martin, Jr. of Debevoise &
Plimpton LLP to conduct an independent investigation of senior managements conduct with respect
to the cardiovascular safety profile of Vioxx during the period Vioxx was developed and marketed.
The review was completed in the third quarter of 2006 and the full report (including appendices)
was made public in September 2006. The Company has provided a copy of the full report and
appendices at its website at
www.merck.com/newsroom/vioxx/martin_report.html. The Company has
included its website address only as an inactive textual reference and does not intend it to be
an active link to its website nor does it incorporate by reference the information contained
therein.
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 October 7, 2005, defendants moved to dismiss the ERISA complaint. On July 11, 2006, Judge
Chesler granted in part and denied in part defendants motion to dismiss.
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, Australia, Turkey, and Israel.
Additional Lawsuits
Based on media reports and other sources, the Company anticipates that additional Vioxx Product
Liability Lawsuits, Vioxx Shareholder Lawsuits and Vioxx Foreign Lawsuits (collectively, the
Vioxx Lawsuits) will be filed against it and/or certain of its current and former officers and
directors in the future.
Insurance
As previously disclosed, the Company has product liability insurance for claims brought in the
Vioxx Product Liability Lawsuits with stated upper limits of approximately $630 million after
deductibles and co-insurance. This insurance provides coverage for legal defense costs and
potential damage amounts that have been or will be incurred in connection with the Vioxx Product
Liability Lawsuits. The Company believes that this insurance coverage extends to additional
Vioxx Product Liability Lawsuits that may be filed in the future. The Company has Directors and
Officers insurance coverage applicable to the Vioxx Securities Lawsuits and Vioxx Derivative
Lawsuits with stated upper limits of approximately $190 million. The Company has fiduciary and
other insurance for the Vioxx ERISA Lawsuits with stated upper limits of approximately $275
million. Additional insurance coverage for these claims may also be available under upper-level
excess policies that provide coverage for a variety of risks. There are disputes with certain
insurers about the availability of some or all of this insurance coverage and there are likely to
be additional disputes. At this time, the Company believes that its insurance coverage with
respect to the Vioxx Lawsuits will not be adequate to cover its defense costs and any losses.
As previously disclosed, the Companys upper level excess insurers (which provide excess
insurance potentially applicable to all of the Vioxx Lawsuits) have commenced an arbitration
seeking, among other things, to cancel those policies, to void all of their obligations under
those policies and to raise other coverage issues with respect to the Vioxx Lawsuits. A second
arbitration against one of the Companys upper level excess insurers has also been commenced.
Merck intends to contest vigorously the insurers claims and will attempt to enforce its rights
under applicable insurance policies. The amounts actually recovered under the policies discussed
in this section may be less than the amounts specified in the preceding paragraph.
Investigations
As previously disclosed, in November 2004, the Company was advised by the staff of the SEC that
it was commencing an informal inquiry concerning Vioxx. On January 28, 2005, the Company
announced that it received notice that the SEC issued a formal notice of investigation. Also,
the Company has received subpoenas from the U.S. Department of Justice (the DOJ) requesting
information related to the Companys research, marketing and selling activities with respect to
Vioxx in a federal health care investigation under criminal statutes. In addition, as previously
disclosed, investigations are being conducted by local authorities in certain cities in Europe in
order to determine whether any criminal charges should be brought concerning Vioxx. The Company
is cooperating with these governmental entities in their respective investigations (the Vioxx
Investigations). The Company cannot predict the outcome of these inquiries; however, they could
result in potential civil and/or criminal dispositions.
- 33 -
As previously disclosed, the Company has received a number of Civil Investigative Demands (CID)
from a group of Attorneys General from 31 states and the District of Columbia who are
investigating whether the Company violated state consumer protection laws when marketing Vioxx.
The Company is cooperating with the Attorneys General in responding to the CIDs.
Reserves
The Company currently anticipates that a number of Vioxx Product Liability Lawsuits will be tried
in the last quarter of 2006 and throughout 2007. The Company
anticipates that the trial in the Oregon securities case will be held in 2007, but the Company cannot predict whether this trial will proceed
on schedule or the timing of any of the other Vioxx Shareholder Lawsuit trials. The Company
believes that it has meritorious defenses to the Vioxx Lawsuits and will vigorously defend
against them. In view of the inherent difficulty of predicting the outcome of litigation,
particularly where there are many claimants and the claimants seek indeterminate damages, the
Company is unable to predict the outcome of these matters, and at this time cannot reasonably
estimate the possible loss or range of loss with respect to the Vioxx Lawsuits. The Company has
not established any reserves for any potential liability relating to the Vioxx Lawsuits or the
Vioxx Investigations, 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, 2005, the Company had established a
reserve of $685 million solely for its future legal defense costs related to the Vioxx
Litigation.
During the first nine months of 2006, the Company spent $325 million in the aggregate in legal
defense costs worldwide related to (i) the Vioxx Product Liability Lawsuits, (ii) the Vioxx
Shareholder Lawsuits, (iii) the Vioxx Foreign Lawsuits, and (iv) the Vioxx Investigations
(collectively, the Vioxx Litigation). In the third quarter, the Company recorded a charge of
$598 million to increase the reserve solely for its future legal defense costs related to the
Vioxx Litigation to $958 million at September 30, 2006. In increasing the reserve, the Company
considered the same factors that it considered when it previously established reserves for the
Vioxx Litigation. Management now believes it has a better estimate of the Companys expenses and
can reasonably estimate such costs through 2008. Some of the significant factors considered in
the establishment and ongoing review of the reserve for the Vioxx legal defense costs 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; the number of cases being
brought against the Company; the costs and outcomes of completed trials and the anticipated
timing, progression, and related costs of pre-trial activities and trials in the Vioxx Product
Liability Lawsuits. Events such as scheduled trials, that are expected to occur throughout 2007
and into 2008, and the inherent inability to predict the ultimate outcomes of such trials, limit
the Companys ability to reasonably estimate its legal costs beyond the end of 2008. 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
The Company is a defendant in product liability lawsuits in the United States involving Fosamax.
As of September 30, 2006, approximately 70 cases have been filed against Merck either in state or
federal court, including four 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. Since the JPML order, over 55 cases have been transferred to Judge Keenan. The Company
will defend against these lawsuits.
Governmental Proceedings
As previously disclosed, the Company has received a subpoena from the DOJ in connection with its
investigation of the Companys marketing and selling activities, including nominal pricing
programs and samples. The Company has been advised that the activities being investigated by the
DOJ are also the subject of a qui tam complaint. As previously disclosed, the Company has
received CIDs from the Attorney General of Texas regarding the Companys marketing and selling
activities relating to Texas. In April 2004, the Company received a subpoena from the office of
the Inspector General for the District of Columbia in connection with an investigation of the
Companys interactions with physicians in the District of Columbia, Maryland, and Virginia. In
November 2004, the Company received a letter request from the
- 34 -
DOJ in connection with its investigation of the Companys pricing of Pepcid. In September 2005,
the Company received a subpoena from the Illinois Attorney General seeking information related to
repackaging of prescription drugs.
As previously disclosed, the Company has received a letter from the DOJ advising it of the
existence of a qui tam complaint alleging that the Company violated certain rules related to its
calculations of best price and other federal pricing benchmark calculations, certain of which may
affect the Companys Medicaid rebate obligation. The DOJ has informed the Company that it does
not intend to intervene in this action and has closed its investigation. The lawsuit continues,
however.
The Company is cooperating with all of these investigations. The Company cannot predict the
outcome of these investigations; however, it is possible that unfavorable outcomes could have a
material adverse effect on the Companys financial position, liquidity and results of operations.
In addition, from time to time, other federal, state or foreign regulators or authorities may
seek information about practices in the pharmaceutical industry or the Companys business
practices in inquiries other than the investigations discussed in this section. It is not
feasible to predict the outcome of any such inquiries.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file ANDAs with the FDA
seeking to market generic forms of the Companys products prior to the expiration of relevant
patents owned by the Company. Generic pharmaceutical manufacturers have submitted ANDAs to the
FDA seeking to market in the United States a generic form of Fosamax, Prilosec, Nexium, Propecia,
Trusopt and Cosopt prior to the expiration of the Companys (and AstraZenecas in the case of
Prilosec and Nexium) patents concerning these products. The generic companies ANDAs generally
include allegations of non-infringement, invalidity and unenforceability of the patents. Generic
manufacturers have received FDA approval to market a generic form of Prilosec. The Company has
filed patent infringement suits in federal court against companies filing ANDAs for generic
alendronate (Fosamax), finasteride (Propecia), dorzolamide (Trusopt) and dorzolamide/timolol
(Cosopt), and AstraZeneca and the Company have filed patent infringement suits in federal court
against companies filing ANDAs for generic omeprazole (Prilosec) and esomeprazole (Nexium).
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.
In June 2006, the Company filed lawsuits against Barr Laboratories, Inc. and Teva Pharmaceutical
Industries Ltd. asserting that their respective manufacturing processes for making their
alendronate products would infringe one or more process patents of the Company. In September
2006, the International Trade Commission agreed to investigate whether Cipla Ltd. would infringe
one or more of Mercks process patents with its proposed supply of generic alendronate to the US
market.
In the case of omeprazole, the trial court in the United States rendered an opinion in October
2002 upholding the validity of the Companys and AstraZenecas patents covering the stabilized
formulation of omeprazole and ruling that one defendants omeprazole product did not infringe
those patents. The other three defendants products were found to infringe the formulation
patents. In December 2003, the U.S. Court of Appeals for the Federal Circuit affirmed the
decision of the trial court. With respect to the Companys patent infringement claims against
certain other generic manufacturers omeprazole products, the trial concluded in June 2006 and a
decision is pending.
Other Litigation
On July 27, 2005, Merck was served with a further shareholder derivative suit filed in the New
Jersey Superior Court for Hunterdon County against the Company and certain current and former
officers and directors. This lawsuit sought to recover or cancel compensation awarded to the
Companys executive officers in 2004, and asserts claims for breach of fiduciary duty, waste and
unjust enrichment. Plaintiff filed an amended complaint in February 2006. Defendants moved to
dismiss plaintiffs amended complaint on April 7, 2006. On July 21, 2006, the Court granted
defendants motion to dismiss based on plaintiffs failure to make pre-suit demand on Mercks
Board of Directors and denied plaintiffs request for leave to amend. Plaintiff has filed a
notice of appeal with the Appellate Division of the New Jersey Superior Court.
Environmental Matters
On June 13, 2006, potassium thiocyanate was accidentally discharged from the Companys plant in
West Point, Pennsylvania through the Upper Gwynedd Township Authoritys wastewater treatment
plant into the Wissahickon Creek, causing a fishkill. Federal and State agencies are
investigating the discharge and the Company is currently cooperating with the investigations.
- 35 -
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, except as indicated below.
During the third quarter of 2006, management of employee payroll data and payroll processing for
the Companys Japanese subsidiary was transitioned to new system applications. This change was
not initiated in response to any deficiency or weakness in internal controls.
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 1 of the Companys Annual Report on Form 10-K for the year ended December 31, 2005,
as filed on March 13, 2006, 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.
- 36 -
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, 2006 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, 2006 |
|
|
2,115,300 |
|
|
$ |
37.73 |
|
|
$ |
6,950.0 |
|
August 1 - August 31, 2006 |
|
|
2,252,200 |
|
|
$ |
40.73 |
|
|
$ |
6,858.0 |
|
September 1 - September 30, 2006 |
|
|
1,917,500 |
|
|
$ |
41.44 |
|
|
$ |
6,779.0 |
|
Total |
|
|
6,285,000 |
|
|
$ |
39.94 |
|
|
$ |
6,779.0 |
|
|
|
|
(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. (October 1, 2004)
Incorporated by reference to Form 10-Q Quarterly Report for the period ended September
30, 2004 |
|
|
|
3.2
|
|
By-Laws of Merck & Co., Inc. (as amended effective May 24, 2005) Incorporated
by reference to Current Report on Form 8-K dated May 24, 2005 |
|
|
|
10.1
|
|
Merck & Co., Inc. Separation Benefits Plan for Nonunion Employees (amended and
restated effective as of July 11, 2006) Incorporated by reference to Current Report on
Form 8-K dated July 11, 2006 |
|
|
|
10.2
|
|
Letter Agreement between Merck & Co., Inc. and Per Wold-Olsen, dated July 19,
2006 Incorporated by reference to Current Report on Form 8-K dated July 28, 2006 |
|
|
|
10.3
|
|
Merck & Co., Inc. Deferral Program (amended and restated as of September 28,
2006) Incorporated by reference to Current Report on Form 8-K dated September 28, 2006 |
|
|
|
12
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
|
|
31.1
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Executive Officer |
|
|
|
31.2
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Financial Officer |
|
|
|
32.1
|
|
Section 1350 Certification of Chief Executive Officer |
|
|
|
32.2
|
|
Section 1350 Certification of Chief Financial Officer |
- 37 -
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 7, 2006 |
/s/ Kenneth C. Frazier
|
|
|
KENNETH C. FRAZIER |
|
|
Executive Vice President and General Counsel |
|
|
|
|
|
Date: November 7, 2006 |
/s/ John Canan
|
|
|
JOHN CANAN |
|
|
Vice President, Controller |
|
|
-38-
EXHIBIT INDEX
|
|
|
Number |
|
Description |
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Merck & Co., Inc. (October 1, 2004)
Incorporated by reference to Form 10-Q Quarterly Report for the period ended September
30, 2004 |
|
|
|
3.2
|
|
By-Laws of Merck & Co., Inc. (as amended effective May 24, 2005) Incorporated
by reference to Current Report on Form 8-K dated May 24, 2005 |
|
|
|
10.1
|
|
Merck & Co., Inc. Separation Benefits Plan for Nonunion Employees (amended and
restated effective as of July 11, 2006) Incorporated by reference to Current Report on
Form 8-K dated July 11, 2006 |
|
|
|
10.2
|
|
Letter Agreement between Merck & Co., Inc. and Per Wold-Olsen, dated July 19,
2006 Incorporated by reference to Current Report on Form 8-K dated July 28, 2006 |
|
|
|
10.3
|
|
Merck & Co., Inc. Deferral Program (amended and restated as of September 28,
2006) Incorporated by reference to Current Report on Form 8-K dated September 28, 2006 |
|
|
|
12
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
|
|
31.1
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Executive Officer |
|
|
|
31.2
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Financial Officer |
|
|
|
32.1
|
|
Section 1350 Certification of Chief Executive Officer |
|
|
|
32.2
|
|
Section 1350 Certification of Chief Financial Officer |
- 39 -