e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2011
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File No. 1-6571
Merck & Co., Inc.
One Merck Drive
Whitehouse Station, N.J. 08889-0100
(908) 423-1000
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Incorporated in New Jersey
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I.R.S. Employer
Identification No. 22-1918501 |
The
number of shares of common stock outstanding as of the close of
business on October 31, 2011:
3,047,921,407
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
TABLE OF CONTENTS
Part I Financial Information
Item 1. Financial Statements
MERCK & CO., INC. AND SUBSIDIARIES
INTERIM CONSOLIDATED STATEMENT OF INCOME
(Unaudited, $ in millions except per share amounts)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2011 |
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2010 |
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2011 |
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2010 |
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Sales |
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$ |
12,022 |
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$ |
11,125 |
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$ |
35,753 |
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$ |
33,893 |
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Costs, Expenses and Other |
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Materials and production |
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4,352 |
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4,191 |
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12,695 |
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13,956 |
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Marketing and administrative |
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3,340 |
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3,192 |
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10,029 |
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9,589 |
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Research and development |
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1,954 |
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2,322 |
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6,048 |
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6,552 |
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Restructuring costs |
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119 |
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50 |
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773 |
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864 |
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Equity income from affiliates |
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(161 |
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(236 |
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(354 |
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(417 |
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Other (income) expense, net |
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66 |
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1,108 |
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809 |
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995 |
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9,670 |
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10,627 |
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30,000 |
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31,539 |
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Income Before Taxes |
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2,352 |
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498 |
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5,753 |
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2,354 |
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Taxes on Income |
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628 |
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126 |
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904 |
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872 |
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Net Income |
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$ |
1,724 |
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$ |
372 |
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$ |
4,849 |
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$ |
1,482 |
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Less: Net Income Attributable to Noncontrolling Interests |
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32 |
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30 |
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89 |
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89 |
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Net Income Attributable to Merck & Co., Inc. |
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$ |
1,692 |
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$ |
342 |
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$ |
4,760 |
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$ |
1,393 |
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Basic Earnings per Common Share
Attributable to
Merck & Co., Inc. Common Shareholders |
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$ |
0.55 |
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$ |
0.11 |
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$ |
1.54 |
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$ |
0.45 |
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Earnings per Common Share Assuming
Dilution Attributable
to Merck & Co., Inc. Common Shareholders |
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$ |
0.55 |
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$ |
0.11 |
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$ |
1.53 |
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$ |
0.44 |
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Dividends Declared per Common Share |
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$ |
0.38 |
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$ |
0.38 |
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$ |
1.14 |
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$ |
1.14 |
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The accompanying notes are an integral part of this consolidated financial statement.
- 2 -
MERCK & CO., INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEET
(Unaudited, $ in millions except per share amounts)
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September 30, |
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December 31, |
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2011 |
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2010 |
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Assets |
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Current Assets |
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Cash and cash equivalents |
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$ |
14,253 |
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$ |
10,900 |
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Short-term investments |
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1,323 |
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1,301 |
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Accounts receivable (net of allowance for doubtful accounts of $129
in 2011 and $104 in 2010) |
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8,136 |
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7,344 |
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Inventories (excludes inventories of $1,382 in 2011 and $1,194
in 2010 classified in Other assets see Note 6) |
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6,239 |
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5,868 |
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Deferred income taxes and other current assets |
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4,158 |
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3,651 |
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Total current assets |
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34,109 |
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29,064 |
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Investments |
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2,423 |
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2,175 |
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Property, Plant and Equipment, at cost, net of accumulated depreciation
of $15,674 in 2011 and $13,481 in 2010 |
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16,383 |
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17,082 |
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Goodwill |
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12,228 |
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12,378 |
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Other Intangibles, Net |
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35,822 |
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39,456 |
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Other Assets |
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5,569 |
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5,626 |
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$ |
106,534 |
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$ |
105,781 |
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Liabilities and Equity |
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Current Liabilities |
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Loans payable and current portion of long-term debt |
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$ |
2,455 |
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$ |
2,400 |
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Trade accounts payable |
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2,282 |
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2,308 |
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Accrued and other current liabilities |
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9,228 |
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8,514 |
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Income taxes payable |
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1,462 |
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1,243 |
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Dividends payable |
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1,166 |
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1,176 |
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Total current liabilities |
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16,593 |
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15,641 |
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Long-Term Debt |
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15,692 |
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15,482 |
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Deferred Income Taxes and Noncurrent Liabilities |
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16,653 |
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17,853 |
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Merck & Co., Inc. Stockholders Equity |
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Common stock, $0.50 par value
Authorized - 6,500,000,000 shares |
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. |
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Issued - 3,576,948,356 shares in 2011 and 2010 |
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1,788 |
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1,788 |
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Other paid-in capital |
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40,717 |
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40,701 |
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Retained earnings |
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38,763 |
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37,536 |
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Accumulated other comprehensive loss |
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(2,713 |
) |
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(3,216 |
) |
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78,555 |
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76,809 |
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Less treasury stock, at cost
525,000,622 shares in 2011 and 494,841,533 shares in 2010 |
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23,415 |
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22,433 |
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Total Merck & Co., Inc. stockholders equity |
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55,140 |
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54,376 |
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Noncontrolling Interests |
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2,456 |
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2,429 |
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Total equity |
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57,596 |
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56,805 |
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$ |
106,534 |
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$ |
105,781 |
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The accompanying notes are an integral part of this consolidated financial statement.
- 3 -
MERCK & CO., INC. AND SUBSIDIARIES
INTERIM CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited, $ in millions)
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Nine Months Ended |
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September 30, |
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2011 |
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2010 |
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Cash Flows from Operating Activities |
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Net income |
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$ |
4,849 |
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$ |
1,482 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
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5,566 |
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5,515 |
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Intangible asset impairment charges |
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461 |
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216 |
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Equity income from affiliates |
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(354 |
) |
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(417 |
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Dividends and distributions from equity affiliates |
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186 |
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264 |
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Gain on AstraZeneca asset option exercise |
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(443 |
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Deferred income taxes |
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(974 |
) |
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(743 |
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Share-based compensation |
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287 |
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400 |
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Other |
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(207 |
) |
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227 |
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Net changes in assets and liabilities |
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(664 |
) |
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782 |
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Net Cash Provided by Operating Activities |
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9,150 |
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7,283 |
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Cash Flows from Investing Activities |
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Capital expenditures |
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(1,120 |
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(1,018 |
) |
Purchases of securities and other investments |
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(4,686 |
) |
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(5,826 |
) |
Proceeds from sales of securities and other investments |
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4,740 |
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3,726 |
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Dispositions of businesses, net of cash divested |
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323 |
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Acquisitions of businesses, net of cash acquired |
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(373 |
) |
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(152 |
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Proceeds from AstraZeneca option exercise |
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647 |
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Other |
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(90 |
) |
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133 |
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Net Cash Used in Investing Activities |
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(1,206 |
) |
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(2,490 |
) |
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Cash Flows from Financing Activities |
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Net change in short-term borrowings |
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1,356 |
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1,573 |
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Payments on debt |
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(1,277 |
) |
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(689 |
) |
Purchases of treasury stock |
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(1,359 |
) |
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(1,593 |
) |
Dividends paid to stockholders |
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(3,526 |
) |
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(3,559 |
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Proceeds from exercise of stock options |
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194 |
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313 |
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Other |
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(61 |
) |
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(191 |
) |
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Net Cash Used in Financing Activities |
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(4,673 |
) |
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(4,146 |
) |
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Effect of Exchange Rate Changes on Cash and Cash Equivalents |
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82 |
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(84 |
) |
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Net Increase in Cash and Cash Equivalents |
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3,353 |
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|
563 |
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Cash and Cash Equivalents at Beginning of Year |
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10,900 |
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|
9,311 |
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Cash and Cash Equivalents at End of Period |
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$ |
14,253 |
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$ |
9,874 |
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The accompanying notes are an integral part of this consolidated financial statement.
- 4 -
Notes to Consolidated Financial Statements (unaudited)
1. Basis of Presentation
The accompanying unaudited interim consolidated financial statements have been prepared
pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information
and disclosures required by accounting principles generally accepted in the United States for
complete consolidated financial statements are not included herein. These interim statements
should be read in conjunction with the audited financial statements and notes thereto included in
Merck & Co., Inc.s Form 10-K filed on February 28, 2011.
On November 3, 2009, Merck & Co., Inc. (Old Merck) and Schering-Plough Corporation
(Schering-Plough) merged (the Merger). In the Merger, Schering-Plough acquired all of the
shares of Old Merck, which became a wholly owned subsidiary of Schering-Plough and was renamed
Merck Sharp & Dohme Corp. Schering-Plough continued as the surviving public company and was
renamed Merck & Co., Inc. (New Merck or the Company). However, for accounting purposes only,
the Merger was treated as an acquisition with Old Merck considered the accounting acquirer.
References in these financial statements to Merck for periods prior to the Merger refer to Old
Merck and for periods after the completion of the Merger to New Merck.
The results of operations of any interim period are not necessarily indicative of the results
of operations for the full year. In the Companys opinion, all adjustments necessary for a fair
presentation of these interim statements have been included and are of a normal and recurring
nature.
Certain reclassifications have been made to prior year amounts to conform to the current year
presentation.
Recently Adopted Accounting Standards
In October 2009, the Financial Accounting Standards Board (FASB) issued new guidance for
revenue recognition with multiple deliverables. The Company adopted this guidance prospectively
for revenue arrangements entered into or materially modified on or after January 1, 2011. This
guidance eliminates the residual method under the current guidance and replaces it with the
relative selling price method when allocating revenue in a multiple deliverable arrangement. The
selling price for each deliverable shall be determined using vendor specific objective evidence of
selling price, if it exists, otherwise third-party evidence of selling price shall be used. If
neither exists for a deliverable, the vendor shall use its best estimate of the selling price for
that deliverable. The effect of adoption on the Companys financial position and results of
operations was not material.
Recently Issued Accounting Standards
In June 2011, the FASB issued amended guidance on the presentation of comprehensive income in
financial statements. This amendment provides companies the option to present the components of
net income and other comprehensive income either as one continuous statement of comprehensive
income or as two separate but consecutive statements. It eliminates the option to present
components of other comprehensive income as part of the statement of changes in stockholders
equity. The provisions of this new guidance are effective for interim and annual periods beginning
in 2012 although earlier adoption is permitted. The adoption of this new guidance will not impact
the Companys financial position, results of operations or cash flows.
In September 2011, the FASB issued amended guidance that simplifies how an entity tests
goodwill for impairment. The amended guidance will allow companies to first assess qualitative
factors to determine if it is more-likely-than-not that the fair value of a reporting unit is less
than its carrying value and whether to perform the two-step goodwill impairment test. The updated
guidance is effective for annual and interim goodwill impairment tests performed for fiscal years
beginning after December 15, 2011, with early adoption
permitted. On October 1, 2011, the Company early adopted the amended guidance in conjunction with its annual impairment testing.
- 5 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
2. Restructuring
Merger Restructuring Program
In February 2010, the Company commenced actions under a global restructuring program (the
Merger Restructuring Program) in conjunction with the integration of the legacy Merck and legacy
Schering-Plough businesses. This Merger Restructuring Program is intended to optimize the cost
structure of the combined company. Additional actions under the program continued during 2010. On
July 29, 2011, the Company announced the latest phase of the Merger Restructuring Program during
which the Company expects to reduce its workforce measured at the time of the Merger by an
additional 12% to 13% across the Company worldwide. A majority of the workforce reductions in this
phase of the Merger Restructuring Program relate to manufacturing (including Animal Health),
administrative and headquarters organizations. Previously announced workforce reductions of
approximately 17% in earlier phases of the program primarily reflect the elimination of positions
in sales, administrative and headquarters organizations, as well as from the sale or closure of
certain manufacturing and research and development sites and the consolidation of office
facilities. The Company will continue to hire employees in strategic growth areas of the business
as necessary. The Company will continue to pursue productivity efficiencies and evaluate its
manufacturing supply chain capabilities on an ongoing basis which may result in future
restructuring actions.
The Company recorded total pretax restructuring costs of $255 million and $384 million in the
third quarter of 2011 and 2010, respectively, and $1.2 billion and $1.5 billion for the first nine
months of 2011 and 2010, respectively, related to this program. Since inception of the Merger
Restructuring Program through September 30, 2011, Merck has recorded total pretax accumulated costs
of approximately $4.5 billion and eliminated approximately 14,200 positions comprised of employee
separations, as well as the elimination of contractors and more than 2,500 positions that were
vacant at the time of the Merger. The restructuring actions under the Merger Restructuring Program
are expected to be substantially completed by the end of 2013, with the exception of certain
actions, principally manufacturing-related, which are expected to be completed by 2015, with the
total cumulative pretax costs estimated to be approximately $5.8 billion to $6.6 billion. The
Company estimates that approximately two-thirds of the cumulative pretax costs relate to cash
outlays, primarily related to employee separation expense. Approximately one-third of the
cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of
facilities to be closed or divested.
2008 Global Restructuring Program
In October 2008, Old Merck announced a global restructuring program (the 2008 Restructuring
Program) to reduce its cost structure, increase efficiency, and enhance competitiveness. As part
of the 2008 Restructuring Program, the Company expects to eliminate approximately 7,200 positions
6,800 active employees and 400 vacancies across the Company worldwide. Pretax restructuring
costs of $20 million were recorded in the third quarter of 2011 and $25 million and $130 million in
the first nine months of 2011 and 2010, respectively, related to the 2008 Restructuring Program.
Since inception of the 2008 Restructuring Program through September 30, 2011, Merck has recorded
total pretax accumulated costs of $1.6 billion and eliminated approximately 6,090 positions
comprised of employee separations and the elimination of contractors and vacant positions. The
2008 Restructuring Program is expected to be completed by the end of 2011, with the exception of certain
manufacturing-related actions, with the total cumulative pretax costs estimated to be up to $2.0
billion. The Company estimates that two-thirds of the cumulative pretax costs relate to cash
outlays, primarily from employee separation expense. Approximately one-third of the cumulative
pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be
closed or divested.
- 6 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
For segment reporting, restructuring charges are unallocated expenses.
The following tables summarize the charges related to Merger Restructuring Program and 2008
Restructuring Program activities by type of cost:
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Three Months Ended September 30, 2011 |
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Nine Months Ended September 30, 2011 |
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Separation |
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Accelerated |
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Separation |
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Accelerated |
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($ in millions) |
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Costs |
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Depreciation |
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Other |
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Total |
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Costs |
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Depreciation |
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Other |
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Total |
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Merger Restructuring Program |
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Materials and production |
|
$ |
|
|
|
$ |
81 |
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|
$ |
7 |
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|
$ |
88 |
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|
$ |
|
|
|
$ |
233 |
|
|
$ |
12 |
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$ |
245 |
|
Marketing and administrative |
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|
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|
22 |
|
|
|
9 |
|
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31 |
|
|
|
|
|
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|
67 |
|
|
|
10 |
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77 |
|
Research and development |
|
|
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|
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|
27 |
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1 |
|
|
|
28 |
|
|
|
|
|
|
|
107 |
|
|
|
(18 |
) |
|
|
89 |
|
Restructuring costs |
|
|
63 |
|
|
|
|
|
|
|
45 |
|
|
|
108 |
|
|
|
670 |
|
|
|
|
|
|
|
95 |
|
|
|
765 |
|
|
|
|
|
63 |
|
|
|
130 |
|
|
|
62 |
|
|
|
255 |
|
|
|
670 |
|
|
|
407 |
|
|
|
99 |
|
|
|
1,176 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
|
|
|
|
|
10 |
|
|
|
(1 |
) |
|
|
9 |
|
|
|
|
|
|
|
16 |
|
|
|
1 |
|
|
|
17 |
|
Restructuring costs |
|
|
5 |
|
|
|
|
|
|
|
6 |
|
|
|
11 |
|
|
|
(3 |
) |
|
|
|
|
|
|
11 |
|
|
|
8 |
|
|
|
|
|
5 |
|
|
|
10 |
|
|
|
5 |
|
|
|
20 |
|
|
|
(3 |
) |
|
|
16 |
|
|
|
12 |
|
|
|
25 |
|
|
|
|
$ |
68 |
|
|
$ |
140 |
|
|
$ |
67 |
|
|
$ |
275 |
|
|
$ |
667 |
|
|
$ |
423 |
|
|
$ |
111 |
|
|
$ |
1,201 |
|
|
|
|
|
Three Months Ended September 30, 2010 |
|
|
Nine Months Ended September 30, 2010 |
|
|
|
Separation |
|
|
Accelerated |
|
|
|
|
|
|
|
|
|
|
Separation |
|
|
Accelerated |
|
|
|
|
|
|
|
($ in millions) |
|
Costs |
|
|
Depreciation |
|
|
Other |
|
|
Total |
|
|
Costs |
|
|
Depreciation |
|
|
Other |
|
|
Total |
|
|
Merger Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
$ |
|
|
|
$ |
13 |
(1) |
|
$ |
41 |
(2) |
|
$ |
54 |
|
|
$ |
|
|
|
$ |
188 |
|
|
$ |
62 |
|
|
$ |
250 |
|
Marketing and administrative |
|
|
|
|
|
|
123 |
(1) |
|
|
11 |
|
|
|
134 |
|
|
|
|
|
|
|
123 |
|
|
|
11 |
|
|
|
134 |
|
Research and development |
|
|
|
|
|
|
153 |
|
|
|
|
|
|
|
153 |
|
|
|
|
|
|
|
266 |
|
|
|
37 |
|
|
|
303 |
|
Restructuring costs |
|
|
67 |
|
|
|
(41 |
) (1) |
|
|
17 |
|
|
|
43 |
|
|
|
650 |
|
|
|
|
|
|
|
160 |
|
|
|
810 |
|
|
|
|
|
67 |
|
|
|
248 |
|
|
|
69 |
|
|
|
384 |
|
|
|
650 |
|
|
|
577 |
|
|
|
270 |
|
|
|
1,497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
|
|
|
|
|
19 |
|
|
|
(33 |
)(2) |
|
|
(14 |
) |
|
|
|
|
|
|
59 |
|
|
|
3 |
|
|
|
62 |
|
Marketing and administrative |
|
|
|
|
|
|
|
|
|
|
(4 |
) |
|
|
(4 |
) |
|
|
|
|
|
|
|
|
|
|
(4 |
) |
|
|
(4 |
) |
Research and development |
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
10 |
|
|
Restructuring costs |
|
|
10 |
|
|
|
|
|
|
|
(3 |
) |
|
|
7 |
|
|
|
41 |
|
|
|
|
|
|
|
21 |
|
|
|
62 |
|
|
|
|
|
10 |
|
|
|
29 |
|
|
|
(40 |
) |
|
|
(1 |
) |
|
|
41 |
|
|
|
69 |
|
|
|
20 |
|
|
|
130 |
|
|
|
|
$ |
77 |
|
|
$ |
277 |
|
|
$ |
29 |
|
|
$ |
383 |
|
|
$ |
691 |
|
|
$ |
646 |
|
|
$ |
290 |
|
|
$ |
1,627 |
|
|
|
|
|
(1) |
|
Amounts reflect third quarter reclassifications of certain accelerated depreciation
charges, recorded in the second quarter, from Materials and production and Restructuring costs
to Marketing and administrative. |
|
(2) |
|
Reflects the reclassification of a second quarter $36 million charge from the 2008
Restructuring Program to the Merger Restructuring Program. |
Separation costs are associated with actual headcount reductions, as well as those
headcount reductions which were probable and could be reasonably estimated. In the first nine
months of 2011, separation costs for the Merger Restructuring Program include a reduction of
separation reserves of approximately $50 million resulting from the Companys decision in the first
quarter to retain approximately 380 employees at its Oss, Netherlands research facility that had
previously been expected to be separated. In the third quarter of 2011 and 2010, approximately
1,300 positions and 2,175 positions, respectively, were eliminated under the Merger Restructuring
Program and approximately 110 positions and 180 positions, respectively, were eliminated under the
2008 Restructuring Program. In the first nine months of 2011 and 2010, approximately 2,635
positions and 9,760 positions, respectively, were eliminated under the Merger Restructuring Program
and approximately 290 positions and 955 positions, respectively, were eliminated under the 2008
Restructuring Program. These position eliminations were comprised of actual headcount reductions
and the elimination of contractors and vacant positions.
Accelerated depreciation costs primarily relate to manufacturing, research and administrative
facilities and equipment to be sold or closed as part of the programs. Accelerated depreciation
costs represent the difference between the depreciation expense to be recognized over the revised
useful life of the site, based upon the anticipated date the site will be closed or divested, and
depreciation expense as determined utilizing the useful life prior to the restructuring actions.
All of the sites have and will continue to operate up through the respective closure dates, and
since future cash flows were sufficient to recover the respective book values, Merck was
required to accelerate depreciation of the site assets rather than write them off immediately.
- 7 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
Other activity in 2011 and 2010 includes asset abandonment, shut-down and other related costs.
Additionally, other activity includes employee-related costs such as curtailment, settlement and
termination charges associated with pension and other postretirement benefit plans (see Note 12)
and share-based compensation costs.
The following table summarizes the charges and spending relating to Merger Restructuring
Program and 2008 Restructuring Program activities for the nine months ended September 30, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Separation |
|
|
Accelerated |
|
|
|
|
|
|
|
($ in millions) |
|
Costs |
|
|
Depreciation |
|
|
Other |
|
|
Total |
|
|
Merger Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring reserves January 1, 2011 |
|
$ |
859 |
|
|
$ |
|
|
|
$ |
64 |
|
|
$ |
923 |
|
Expense |
|
|
670 |
|
|
|
407 |
|
|
|
99 |
|
|
|
1,176 |
|
(Payments) receipts, net |
|
|
(417 |
) |
|
|
|
|
|
|
(121 |
) |
|
|
(538 |
) |
Non-cash activity |
|
|
|
|
|
|
(407 |
) |
|
|
7 |
|
|
|
(400 |
) |
|
Restructuring reserves September 30, 2011 (1) |
|
$ |
1,112 |
|
|
$ |
|
|
|
$ |
49 |
|
|
$ |
1,161 |
|
|
2008 Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring reserves January 1, 2011 |
|
$ |
196 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
196 |
|
Expense |
|
|
(3 |
) |
|
|
16 |
|
|
|
12 |
|
|
|
25 |
|
(Payments) receipts, net |
|
|
(53 |
) |
|
|
|
|
|
|
(11 |
) |
|
|
(64 |
) |
Non-cash activity |
|
|
|
|
|
|
(16 |
) |
|
|
(1 |
) |
|
|
(17 |
) |
|
Restructuring reserves September 30, 2011 (1) |
|
$ |
140 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
140 |
|
|
|
|
|
(1) |
|
The cash outlays associated with the Merger Restructuring Program and the 2008
Restructuring Program are expected to be substantially completed by the end of 2013 and 2011,
respectively, with the exception of certain actions, principally manufacturing-related, which
are expected to be completed by 2015. |
Legacy Schering-Plough Program
Prior to the Merger, Schering-Plough commenced a Productivity Transformation Program which was
designed to reduce and avoid costs and increase productivity. The Company recorded accelerated
depreciation costs included in Materials and production of
$2 million and $4 million for the third
quarter of 2011 and 2010, respectively, and $18 million and $13 million for the first nine months
of 2011 and 2010, respectively. In addition, the first nine months of 2010 includes a net gain of
$8 million reflected in Restructuring costs primarily related to the sale of a manufacturing
facility. The remaining reserve associated with this program was $30 million at September 30, 2011.
3. Acquisitions, Divestitures, Research Collaborations and License Agreements
In May 2011, Merck completed the acquisition of Inspire Pharmaceuticals, Inc. (Inspire), a
specialty pharmaceutical company focused on developing and commercializing ophthalmic products.
Under the terms of the merger agreement, Merck acquired all outstanding shares of common stock of
Inspire at a price of $5.00 per share in cash for a total of approximately $420 million. The
transaction was accounted for as an acquisition of a business; accordingly, the assets acquired and
liabilities assumed were recorded at their respective fair values as of the acquisition date. The
determination of fair value requires management to make significant estimates and assumptions. In
connection with the acquisition, substantially all of the purchase price was allocated to Inspires
product and product right intangible assets and related deferred tax liabilities, a deferred tax
asset relating to Inspires net operating loss carryforwards, and goodwill. Certain estimated
values are not yet finalized and may be subject to change. The Company expects to finalize these
amounts as soon as possible, but no later than one year from the acquisition date. This
transaction closed on May 16, 2011, and accordingly, the results of operations of the acquired
business have been included in the Companys results of operations beginning after the acquisition
date. Pro forma financial information has not been included because Inspires historical financial
results are not significant when compared with the Companys financial results.
In March 2011, the Company sold the Merck BioManufacturing Network, a leading provider of
contract manufacturing and development services for the biopharmaceutical industry and wholly owned
by Merck, to Fujifilm Corporation (Fujifilm). Under the terms of the agreement, Fujifilm
purchased all of the equity interests in two Merck subsidiaries which together own all assets of
the Merck BioManufacturing Network comprising
- 8 -
Notes to Consolidated Financial Statements (unaudited) (continued)
facilities located in Research Triangle Park, North
Carolina and Billingham, U.K.; and including manufacturing contracts; business support operations
and a highly skilled workforce. As part of the agreement with Fujifilm, Merck has committed to
certain continued development and manufacturing activities with these two companies. The
transaction resulted in a gain of $127 million in the first nine months of 2011 reflected in Other
(income) expense, net.
4. Collaborative Arrangements
The Company continues its strategy of establishing external alliances to complement its
substantial internal research capabilities, including research collaborations, licensing
preclinical and clinical compounds and technology platforms to drive both near- and long-term
growth. The Company supplements its internal research with a licensing and external alliance
strategy focused on the entire spectrum of collaborations from early research to late-stage
compounds, as well as new technologies across a broad range of therapeutic areas. These
arrangements often include upfront payments and royalty or profit share payments, contingent upon
the occurrence of certain future events linked to the success of the asset in development, as well
as expense reimbursements or payments to the third party.
Cozaar/Hyzaar
In 1989, Old Merck and E.I. duPont de Nemours and Company (DuPont) agreed to form a
long-term research and marketing collaboration to develop a class of therapeutic agents for high
blood pressure and heart disease, discovered by DuPont, called angiotensin II receptor antagonists,
which include Cozaar and Hyzaar. In return, Old Merck provided DuPont marketing rights in the
United States and Canada to its prescription medicines, Sinemet and Sinemet CR (the Company has
since regained global marketing rights to Sinemet and Sinemet CR). Pursuant to a 1994 agreement
with DuPont, the Company has an exclusive licensing agreement to market Cozaar and Hyzaar in return
for royalties and profit share payments to DuPont. The patents that provided market exclusivity in
the United States for Cozaar and Hyzaar expired in April 2010. In addition, Cozaar and Hyzaar lost
patent protection in a number of major European markets in March 2010.
Remicade/Simponi
In 1998, a subsidiary of Schering-Plough entered into a licensing agreement with Centocor
Ortho Biotech Inc. (Centocor), a Johnson & Johnson (J&J) company, to market Remicade, which is
prescribed for the treatment of inflammatory diseases. In 2005, Schering-Ploughs subsidiary
exercised an option under its contract with Centocor for license rights to develop and
commercialize Simponi (golimumab), a fully human monoclonal antibody. The Company had exclusive
marketing rights to both products outside the United States, Japan and certain other Asian markets.
In December 2007, Schering-Plough and Centocor revised their distribution agreement regarding the
development, commercialization and distribution of both Remicade and Simponi, extending the
Companys rights to exclusively market Remicade to match the duration of the Companys exclusive
marketing rights for Simponi. In addition, Schering-Plough and Centocor agreed to share certain
development costs relating to Simponis auto-injector delivery system. On October 6, 2009, the
European Commission approved Simponi as a treatment for rheumatoid arthritis and other immune
system disorders in two presentations a novel auto-injector and a prefilled syringe. As a
result, the Companys marketing rights for both products extend for 15 years from the first
commercial sale of Simponi in the European Union (EU) following the receipt of pricing and
reimbursement approval within the EU. In April 2011, Merck and J&J reached agreement to amend the
distribution rights to Remicade and Simponi. Under the terms of the amended distribution
agreement, Merck relinquished exclusive marketing rights for Remicade and Simponi to J&J in
territories including Canada, Central and South America, the Middle East, Africa and Asia Pacific
effective July 1, 2011. Merck retained exclusive marketing rights throughout Europe, Russia and
Turkey (Retained Territories). In addition, beginning July 1, 2011, all profit derived from
Mercks exclusive distribution of the two products in the Retained Territories is being equally
divided between Merck and J&J. Under the prior terms of the distribution agreement, the
contribution income (profit) split, which was at 58% to Merck and 42% percent to J&J, would have
declined for Merck and increased for J&J each year until 2014, when it would have been equally
divided. J&J also received a one-time payment of $500 million in April 2011, which the Company
recorded as a charge to Other (income) expense, net in the first quarter of 2011.
- 9 -
Notes to Consolidated Financial Statements (unaudited) (continued)
5. Financial Instruments
Derivative Instruments and Hedging Activities
The Company manages the impact of foreign exchange rate movements and interest rate movements
on its earnings, cash flows and fair values of assets and liabilities through operational means and
through the use of various financial instruments, including derivative instruments.
A significant portion of the Companys revenues and earnings in foreign affiliates is exposed
to changes in foreign exchange rates. The objectives and accounting related to the Companys
foreign currency risk management program, as well as its interest rate risk management activities
are discussed below.
Foreign Currency Risk Management
A significant portion of the Companys revenues are denominated in foreign currencies. The
Company has established revenue hedging and balance sheet risk management programs to protect
against volatility of future foreign currency cash flows and changes in fair value caused by
volatility in foreign exchange rates.
The objective of the revenue hedging program is to reduce the potential for longer-term
unfavorable changes in foreign exchange to decrease the U.S. dollar value of future cash flows
derived from foreign currency denominated sales, primarily the euro and Japanese yen. To achieve
this objective, the Company will partially hedge forecasted foreign currency denominated
third-party and intercompany distributor entity sales that are expected to occur over its planning
cycle, typically no more than three years into the future. The Company will layer in hedges over
time, increasing the portion of third-party and intercompany distributor entity sales hedged as it
gets closer to the expected date of the forecasted foreign currency denominated sales, such that it
is probable the hedged transaction will occur. The portion of sales hedged is based on assessments
of cost-benefit profiles that consider natural offsetting exposures, revenue and exchange rate
volatilities and correlations, and the cost of hedging instruments. The hedged anticipated sales
are a specified component of a portfolio of similarly denominated foreign currency-based sales
transactions, each of which responds to the hedged risk in the same manner. The Company manages
its anticipated transaction exposure principally with purchased local currency put options, which
provide the Company with a right, but not an obligation, to sell foreign currencies in the future
at a predetermined price. If the U.S. dollar strengthens relative to the currency of the hedged
anticipated sales, total changes in the options cash flows offset the decline in the expected
future U.S. dollar cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar
weakens, the options value reduces to zero, but the Company benefits from the increase in the
value of the anticipated foreign currency cash flows.
In connection with the Companys revenue hedging program, a purchased collar option strategy
may be utilized. With a purchased collar option strategy, the Company writes a local currency call
option and purchases a local currency put option. As compared to a purchased put option strategy
alone, a purchased collar strategy reduces the upfront costs associated with purchasing puts
through the collection of premium by writing call options. If the U.S. dollar weakens relative to
the currency of the hedged anticipated sales, the purchased put option value of the collar strategy
reduces to zero, but the Company benefit from the increase in the value of its anticipated foreign
currency cash flows would be capped at the strike level of the written call. If the U.S. dollar
strengthens relative to the currency of the hedged anticipated sales, the written call option value
of the collar strategy reduces to zero and the changes in the purchased put cash flows of the
collar strategy would offset the decline in the expected future U.S. dollar cash flows of the
hedged foreign currency sales.
The Company may also utilize forward contracts in its revenue hedging program. If the U.S.
dollar strengthens relative to the currency of the hedged anticipated sales, the increase in the
fair value of the forward contracts offsets the decrease in the expected future U.S. dollar cash
flows of the hedged foreign currency sales. Conversely, if the U.S. dollar weakens, the decrease
in the fair value of the forward contracts offsets the increase in the value of the anticipated
foreign currency cash flows.
- 10 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The fair values of these derivative contracts are recorded as either assets (gain positions)
or liabilities (loss positions) in the Consolidated Balance Sheet. Changes in the fair value of
derivative contracts are recorded each period in either current earnings or Other comprehensive
income (OCI), depending on whether the derivative is designated as part of a hedge transaction
and, if so, the type of hedge transaction. For derivatives that are designated as cash flow
hedges, the effective portion of the unrealized gains or losses on these contracts is recorded in
Accumulated other comprehensive income (AOCI) and reclassified into Sales when the hedged
anticipated revenue is recognized. The hedge relationship is highly effective and hedge
ineffectiveness has been de minimis. For those derivatives which are not designated as cash flow
hedges, unrealized gains or losses are recorded to Sales each period. The cash flows from these
contracts are reported as operating activities in the Consolidated Statement of Cash Flows. The
Company does not enter into derivatives for trading or speculative purposes.
The primary objective of the balance sheet risk management program is to mitigate the exposure
of foreign currency denominated net monetary assets of foreign subsidiaries where the U.S. dollar
is the functional currency from the effects of volatility in foreign exchange that might occur
prior to their conversion to U.S. dollars. In these instances, Merck principally utilizes forward
exchange contracts, which enable the Company to buy and sell foreign currencies in the future at
fixed exchange rates and economically offset the consequences of changes in foreign exchange from
the monetary assets. Merck routinely enters into contracts to offset the effects of exchange on
exposures denominated in developed country currencies, primarily the euro and Japanese yen. For
exposures in developing country currencies, the Company will enter into forward contracts to
partially offset the effects of exchange on exposures when it is deemed economical to do so based
on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the
exchange rate and the cost of the hedging instrument. The Company will also minimize the effect of
exchange on monetary assets and liabilities by managing operating activities and net asset
positions at the local level.
Foreign currency denominated monetary assets and liabilities of foreign subsidiaries where the
U.S. dollar is the functional currency are remeasured at spot rates in effect on the balance sheet
date with the effects of changes in spot rates reported in Other (income) expense, net. The
forward contracts are not designated as hedges and are marked to market through Other (income)
expense, net. Accordingly, fair value changes in the forward contracts help mitigate the changes
in the value of the remeasured assets and liabilities attributable to changes in foreign currency
exchange rates, except to the extent of the spot-forward differences. These differences are not
significant due to the short-term nature of the contracts, which typically have average maturities
at inception of less than one year.
When applicable, the Company uses forward contracts to hedge the changes in fair value of
certain foreign currency denominated available-for-sale securities attributable to fluctuations in
foreign currency exchange rates. These derivative contracts are designated as fair value hedges.
Accordingly, changes in the fair value of the hedged securities due to fluctuations in spot rates
are recorded in Other (income) expense, net, and are offset by the fair value changes in the
forward contracts attributable to spot rate fluctuations. Changes in the contracts fair value due
to spot-forward differences are excluded from the designated hedge relationship and recognized in
Other (income) expense, net. These amounts, as well as hedge ineffectiveness, were not
significant. The cash flows from these contracts are reported as operating activities in the
Consolidated Statement of Cash Flows.
Foreign exchange risk is also managed through the use of foreign currency debt. The Companys
senior unsecured euro-denominated notes have been designated as, and are effective as, economic
hedges of the net investment in a foreign operation. Accordingly, foreign currency transaction
gains or losses on the euro-denominated debt instruments are included in foreign currency
translation adjustment within OCI.
The Company also uses forward exchange contracts to hedge its net investment in foreign
operations against adverse movements in exchange rates. The forward contracts are designated as
hedges of the net investment in a foreign operation. The Company hedges a portion of the net
investment in certain of its foreign operations and measures ineffectiveness based upon changes in
spot foreign exchange rates. The effective portion of the unrealized gains or losses on these
contracts is recorded in foreign currency translation adjustment within OCI, and remains in AOCI
until either the sale or complete or substantially complete liquidation of the subsidiary. The
cash flows from these contracts are reported as investing activities in the Consolidated Statement
of Cash Flows.
- 11 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Interest Rate Risk Management
In the
third quarter of 2011, the Company terminated 11 interest rate swap contracts with a total notional
amount of $1.6 billion. These swaps effectively converted $1.6 billion of its fixed-rate notes,
with maturity dates ranging from June 2015 to January 2016, to floating rate instruments. As a
result of the third quarter swap terminations, the Company received $113 million in cash, which
included $7 million in accrued interest. The corresponding $106 million basis adjustment of the
debt associated with the terminated swap contracts was deferred and is being amortized as a
reduction of interest expense over the respective term of the notes. In the second quarter of 2011, the Company terminated nine interest rate swap contracts with a
total notional amount of $3.5 billion. These swaps effectively converted $3.5 billion of its
fixed-rate notes, with maturity dates ranging from March 2015 to June 2019, to floating rate
instruments. As a result of the second quarter swap terminations, the Company received $175
million in cash, which included $36 million in accrued interest. The corresponding $139 million
basis adjustment of the debt associated with the terminated swap contracts was deferred and is
being amortized as a reduction of interest expense over the respective term of the notes. The cash flows from these
contracts are reported as operating activities in the Consolidated Statement of Cash Flows.
At September 30, 2011, the Company was a party to two pay-floating, receive-fixed interest
rate swap contracts that mature in the fourth quarter of 2011 with notional amounts of $125 million
each that effectively convert the Companys $250 million, 5.125% fixed-rate notes due 2011 to
floating rate instruments. The interest rate swap contracts are designated hedges of the fair value
changes in the notes attributable to changes in the benchmark London Interbank Offered Rate
(LIBOR) swap rate. The fair value changes in the notes attributable to changes in the benchmark
interest rate are recorded in interest expense and offset by the fair value changes in the swap
contracts. The cash flows from these contracts are reported as operating activities in the
Consolidated Statement of Cash Flows.
Presented in the table below is the fair value of derivatives segregated between those
derivatives that are designated as hedging instruments and those that are not designated as hedging
instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2011 |
|
|
December 31, 2010 |
|
|
|
|
|
Fair Value of Derivative |
|
|
U.S. Dollar |
|
|
Fair Value of Derivative |
|
|
U.S. Dollar |
|
($ in millions) |
|
Balance Sheet Caption |
|
Asset |
|
|
Liability |
|
|
Notional |
|
|
Asset |
|
|
Liability |
|
|
Notional |
|
|
Derivatives Designated as Hedging
Instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts (current) |
|
Deferred income taxes and other current assets |
|
$ |
147 |
|
|
$ |
|
|
|
$ |
3,115 |
|
|
$ |
167 |
|
|
$ |
|
|
|
$ |
2,344 |
|
Foreign exchange contracts (non-current) |
|
Other assets |
|
|
364 |
|
|
|
|
|
|
|
4,723 |
|
|
|
310 |
|
|
|
|
|
|
|
3,720 |
|
Foreign exchange contracts (current) |
|
Accrued and other current liabilities |
|
|
|
|
|
|
121 |
|
|
|
2,390 |
|
|
|
|
|
|
|
18 |
|
|
|
1,505 |
|
Foreign exchange contracts (non-current) |
|
Deferred income taxes and noncurrent liabilities |
|
|
|
|
|
|
2 |
|
|
|
59 |
|
|
|
|
|
|
|
6 |
|
|
|
503 |
|
Interest rate swaps (current) |
|
Deferred income taxes and other current assets |
|
|
6 |
|
|
|
|
|
|
|
250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swaps (non-current) |
|
Other assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
1,000 |
|
Interest rate swaps (non-current) |
|
Deferred income taxes and noncurrent liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 |
|
|
|
850 |
|
|
|
|
|
|
$ |
517 |
|
|
$ |
123 |
|
|
$ |
10,537 |
|
|
$ |
533 |
|
|
$ |
31 |
|
|
$ |
9,922 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives Not Designated as Hedging Instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts (current) |
|
Deferred income taxes and other current assets |
|
$ |
347 |
|
|
$ |
|
|
|
$ |
9,496 |
|
|
$ |
95 |
|
|
$ |
|
|
|
$ |
6,295 |
|
|
Foreign exchange contracts (current) |
|
Accrued and other current liabilities |
|
|
|
|
|
|
21 |
|
|
|
2,176 |
|
|
|
|
|
|
|
30 |
|
|
|
4,229 |
|
|
|
|
|
|
$ |
347 |
|
|
$ |
21 |
|
|
$ |
11,672 |
|
|
$ |
95 |
|
|
$ |
30 |
|
|
$ |
10,524 |
|
|
|
|
|
|
$ |
864 |
|
|
$ |
144 |
|
|
$ |
22,209 |
|
|
$ |
628 |
|
|
$ |
61 |
|
|
$ |
20,446 |
|
|
- 12 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The table below provides information on the location and pretax gain or loss amounts for
derivatives that are: (i) designated in a fair value hedging relationship, (ii) designated in a
cash flow hedging relationship, (iii) designated in a foreign currency net investment hedging
relationship and (iv) not designated in a hedging relationship:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Derivatives designated in fair value hedging relationships |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap contracts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of gain recognized in Other (income) expense, net on derivatives |
|
$ |
(40 |
) |
|
$ |
(29 |
) |
|
$ |
(203 |
) |
|
$ |
(64 |
) |
Amount of loss recognized in Other (income) expense, net on hedged item |
|
|
40 |
|
|
|
29 |
|
|
|
203 |
|
|
|
64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives designated in foreign currency cash flow hedging relationships
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of loss (gain) reclassified from AOCI to Sales |
|
|
30 |
|
|
|
(13 |
) |
|
|
57 |
|
|
|
1 |
|
Amount of (gain) loss recognized in OCI on derivatives |
|
|
(70 |
) |
|
|
234 |
|
|
|
183 |
|
|
|
(50 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives designated in foreign currency net investment hedging relationships |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of gain recognized in Other (income) expense, net on derivatives (1) |
|
|
(1 |
) |
|
|
|
|
|
|
(9 |
) |
|
|
|
|
Amount of loss recognized in OCI on derivatives |
|
|
124 |
|
|
|
|
|
|
|
158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated in a hedging relationship |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of (gain) loss recognized in Other (income) expense, net on derivatives (2) |
|
|
(351 |
) |
|
|
198 |
|
|
|
(31 |
) |
|
|
13 |
|
Amount of loss (gain) recognized in Sales on hedged item |
|
|
|
|
|
|
30 |
|
|
|
|
|
|
|
(83 |
) |
|
|
|
|
(1) |
|
There was no ineffectiveness on the hedge. Represents the amount excluded
from hedge effectiveness testing. |
|
(2) |
|
These derivative contracts mitigate changes in the value of remeasured foreign
currency denominated monetary assets and liabilities attributable to changes in foreign
currency exchange rates. |
At September 30, 2011, the Company estimates $50 million of pretax net unrealized losses
on derivatives maturing within the next 12 months that hedge foreign currency denominated sales
over that same period will be reclassified from AOCI to Sales. The amount ultimately reclassified
to Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately
determined by actual exchange rates at maturity.
Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to
transfer a liability (an exit price) in the principal or most advantageous market for the asset or
liability in an orderly transaction between market participants on the measurement date. Entities
are required to use a fair value hierarchy which maximizes the use of observable inputs and
minimizes the use of unobservable inputs when measuring fair value. There are three levels of
inputs that may be used to measure fair value:
Level 1 - Quoted prices in active markets for identical assets or liabilities. The Companys
Level 1 assets include equity securities that are traded in an active exchange market.
Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar
assets or liabilities, or other inputs that are observable or can be corroborated by observable
market data for substantially the full term of the assets or liabilities. The Companys Level 2
assets and liabilities primarily include debt securities with quoted prices that are traded less
frequently than exchange-traded instruments, corporate notes and bonds, U.S. and foreign government
and agency securities, certain mortgage-backed and asset-backed securities, municipal securities,
commercial paper and derivative contracts whose values are determined using pricing models with
inputs that are observable in the market or can be derived principally from or corroborated by
observable market data.
Level 3 - Unobservable inputs that are supported by little or no market activity and that are
financial instruments whose values are determined using pricing models, discounted cash flow
methodologies, or similar techniques, as well as instruments for which the determination of fair
value requires significant judgment or estimation. The Companys Level 3 assets included certain
mortgage-backed securities with limited market activity.
If the inputs used to measure the financial assets and liabilities fall within more than one
level described above, the categorization is based on the lowest level input that is significant to
the fair value measurement of the instrument.
- 13 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis
Financial assets and liabilities measured at fair value on a recurring basis are summarized
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using |
|
|
Fair Value Measurements Using |
|
|
|
Quoted Prices |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
Quoted Prices |
|
|
Significant |
|
|
|
|
|
|
|
|
|
In Active |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
In Active |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
Markets for |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
Markets for |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
|
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
|
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
($ in millions) |
|
September 30, 2011 |
|
|
December 31, 2010 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate notes and bonds |
|
$ |
|
|
|
$ |
1,554 |
|
|
$ |
|
|
|
$ |
1,554 |
|
|
$ |
|
|
|
$ |
1,133 |
|
|
$ |
|
|
|
$ |
1,133 |
|
Commercial paper |
|
|
|
|
|
|
1,054 |
|
|
|
|
|
|
|
1,054 |
|
|
|
|
|
|
|
1,046 |
|
|
|
|
|
|
|
1,046 |
|
U.S. government and agency securities |
|
|
|
|
|
|
605 |
|
|
|
|
|
|
|
605 |
|
|
|
|
|
|
|
500 |
|
|
|
|
|
|
|
500 |
|
Municipal securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
361 |
|
|
|
|
|
|
|
361 |
|
Asset-backed securities (1) |
|
|
|
|
|
|
173 |
|
|
|
|
|
|
|
173 |
|
|
|
|
|
|
|
171 |
|
|
|
|
|
|
|
171 |
|
Mortgage-backed securities (1) |
|
|
|
|
|
|
163 |
|
|
|
|
|
|
|
163 |
|
|
|
|
|
|
|
99 |
|
|
|
13 |
|
|
|
112 |
|
Foreign government bonds |
|
|
|
|
|
|
51 |
|
|
|
|
|
|
|
51 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
10 |
|
Equity securities |
|
|
94 |
|
|
|
49 |
|
|
|
|
|
|
|
143 |
|
|
|
117 |
|
|
|
23 |
|
|
|
|
|
|
|
140 |
|
Other debt securities |
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
94 |
|
|
|
3,652 |
|
|
|
|
|
|
|
3,746 |
|
|
|
117 |
|
|
|
3,346 |
|
|
|
13 |
|
|
|
3,476 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities held for employee
compensation |
|
|
184 |
|
|
|
|
|
|
|
|
|
|
|
184 |
|
|
|
181 |
|
|
|
|
|
|
|
|
|
|
|
181 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative assets (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased currency options |
|
|
|
|
|
|
511 |
|
|
|
|
|
|
|
511 |
|
|
|
|
|
|
|
477 |
|
|
|
|
|
|
|
477 |
|
Forward exchange contracts |
|
|
|
|
|
|
347 |
|
|
|
|
|
|
|
347 |
|
|
|
|
|
|
|
95 |
|
|
|
|
|
|
|
95 |
|
Interest rate swaps |
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
|
|
864 |
|
|
|
|
|
|
|
864 |
|
|
|
|
|
|
|
628 |
|
|
|
|
|
|
|
628 |
|
|
Total assets |
|
$ |
278 |
|
|
$ |
4,516 |
|
|
$ |
|
|
|
$ |
4,794 |
|
|
$ |
298 |
|
|
$ |
3,974 |
|
|
$ |
13 |
|
|
$ |
4,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative liabilities (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Written currency options |
|
$ |
|
|
|
$ |
4 |
|
|
$ |
|
|
|
$ |
4 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Forward exchange contracts |
|
|
|
|
|
|
140 |
|
|
|
|
|
|
|
140 |
|
|
|
|
|
|
|
54 |
|
|
|
|
|
|
|
54 |
|
Interest rate swaps |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 |
|
|
|
|
|
|
|
7 |
|
|
Total liabilities |
|
$ |
|
|
|
$ |
144 |
|
|
$ |
|
|
|
$ |
144 |
|
|
$ |
|
|
|
$ |
61 |
|
|
$ |
|
|
|
$ |
61 |
|
|
|
|
|
(1) |
|
Primarily all of the asset-backed securities are highly-rated (Standard & Poors rating
of AAA and Moodys Investors Service rating of Aaa), secured primarily by credit card, auto
loan, and home equity receivables, with weighted-average lives of primarily 5 years or less.
Mortgage-backed securities represent AAA-rated securities issued or unconditionally guaranteed
as to payment of principal and interest by U.S. government agencies. |
|
(2) |
|
The fair value determination of derivatives includes an assessment of the credit
risk of counterparties to the derivatives and the Companys own credit risk, the effects of
which were not significant. |
There were no significant transfers between Level 1 and Level 2 during the third quarter
or first nine months of 2011. As of September 30, 2011, Cash and cash equivalents of $14.3 billion
included $13.3 billion of cash equivalents.
Level 3 Valuation Techniques:
Financial assets are considered Level 3 when their fair values are determined using pricing
models, discounted cash flow methodologies or similar techniques and at least one significant model
assumption or input is unobservable. Level 3 financial assets also include certain investment
securities for which there is limited market activity such that the determination of fair value
requires significant judgment or estimation. The Companys Level 3 investment securities included
certain mortgage-backed securities that were valued primarily using pricing models for which
management understands the methodologies. These models incorporate transaction details such as
contractual terms, maturity, timing and amount of future cash inflows, as well as assumptions about
liquidity and credit valuation adjustments of marketplace participants.
- 14 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The table below provides a summary of the changes in fair value of all financial assets
measured at fair value on a recurring basis using significant unobservable inputs (Level 3):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Beginning balance |
|
$ |
|
|
|
$ |
17 |
|
|
$ |
13 |
|
|
$ |
72 |
|
Sales |
|
|
|
|
|
|
(2 |
) |
|
|
(13 |
) |
|
|
(63 |
) |
Settlements |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
Total realized and unrealized gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18 |
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10 |
) |
|
Ending balance |
|
$ |
|
|
|
$ |
15 |
|
|
$ |
|
|
|
$ |
15 |
|
|
Losses recorded in earnings for Level 3
assets still held at September 30 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
(1) |
|
Amounts are recorded in Other (income) expense, net. |
Financial Instruments not Measured at Fair Value
Some of the Companys financial instruments are not measured at fair value on a recurring
basis but are recorded at amounts that approximate fair value due to their liquid or short-term
nature, such as cash and cash equivalents, receivables and payables.
The estimated fair value of loans payable and long-term debt (including current portion) at
September 30, 2011 was $19.7 billion compared with a carrying value of $18.1 billion and at
December 31, 2010 was $18.7 billion compared with a carrying value of $17.9 billion. Fair value
was estimated using quoted dealer prices.
A summary of gross unrealized gains and losses on available-for-sale investments recorded in
AOCI is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2011 |
|
|
December 31, 2010 |
|
|
|
Fair |
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Fair |
|
|
Amortized |
|
|
Gross Unrealized |
|
($ in millions) |
|
Value |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
|
|
|
Corporate notes and bonds |
|
$ |
1,554 |
|
|
$ |
1,548 |
|
|
$ |
13 |
|
|
$ |
(7 |
) |
|
$ |
1,133 |
|
|
$ |
1,124 |
|
|
$ |
12 |
|
|
$ |
(3 |
) |
Commercial paper |
|
|
1,054 |
|
|
|
1,054 |
|
|
|
|
|
|
|
|
|
|
|
1,046 |
|
|
|
1,046 |
|
|
|
|
|
|
|
|
|
U.S. government and agency
securities |
|
|
605 |
|
|
|
602 |
|
|
|
3 |
|
|
|
|
|
|
|
500 |
|
|
|
501 |
|
|
|
1 |
|
|
|
(2 |
) |
Municipal securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
361 |
|
|
|
359 |
|
|
|
4 |
|
|
|
(2 |
) |
Asset-backed securities |
|
|
173 |
|
|
|
172 |
|
|
|
1 |
|
|
|
|
|
|
|
171 |
|
|
|
170 |
|
|
|
1 |
|
|
|
|
|
Mortgage-backed securities |
|
|
163 |
|
|
|
162 |
|
|
|
2 |
|
|
|
(1 |
) |
|
|
112 |
|
|
|
108 |
|
|
|
5 |
|
|
|
(1 |
) |
Foreign government bonds |
|
|
51 |
|
|
|
51 |
|
|
|
|
|
|
|
|
|
|
|
10 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
Other debt securities |
|
|
3 |
|
|
|
1 |
|
|
|
2 |
|
|
|
|
|
|
|
3 |
|
|
|
1 |
|
|
|
2 |
|
|
|
|
|
Equity securities |
|
|
327 |
|
|
|
313 |
|
|
|
14 |
|
|
|
|
|
|
|
321 |
|
|
|
295 |
|
|
|
34 |
|
|
|
(8 |
) |
|
|
|
$ |
3,930 |
|
|
$ |
3,903 |
|
|
$ |
35 |
|
|
$ |
(8 |
) |
|
$ |
3,657 |
|
|
$ |
3,614 |
|
|
$ |
59 |
|
|
$ |
(16 |
) |
|
Available-for-sale debt securities included in Short-term investments totaled $1.3 billion at
September 30, 2011. Of the remaining debt securities, $2.0 billion mature within five years. At
September 30, 2011, there were no debt securities pledged as collateral.
Concentrations of Credit Risk
On an ongoing basis, the Company monitors concentrations of credit risk associated with
corporate issuers of securities and financial institutions with which it conducts business. Credit
exposure limits are established to limit a concentration with any single issuer or institution.
Cash and investments are placed in instruments that meet high credit quality standards, as
specified in the Companys investment policy guidelines. Approximately two-thirds of the Companys
cash and cash equivalents are invested in three highly-rated money market funds.
The majority of the Companys accounts receivable arise from product sales in the United
States and Europe and are primarily due from drug wholesalers and retailers, hospitals, government
agencies, managed health
- 15 -
Notes to Consolidated Financial Statements (unaudited) (continued)
care providers and pharmacy benefit managers. The Company monitors the
financial performance and credit worthiness of its customers so that it can properly assess and
respond to changes in their credit profile. The Company also continues to monitor economic
conditions, including the volatility associated with international sovereign economies, and
associated impacts on the financial markets and its business, taking into consideration the global
economic downturn and the sovereign debt issues in certain European countries. The Company
continues to monitor the credit and economic conditions within Greece, Spain, Italy and Portugal,
among other members of the EU. These deteriorating economic conditions, as well as inherent
variability of timing of cash receipts, have resulted in, and may continue to result in, an
increase in the average length of time that it takes to collect accounts receivable outstanding.
The Company does not expect to have write-offs or adjustments to accounts receivable which would
have a material adverse impact on its financial position or results
of operations. At September 30, 2011, the Companys accounts receivable in Greece, Italy, Spain and Portugal totaled
approximately $1.6 billion of which hospital and public sector receivables were approximately 75%.
As of September 30, 2011, the Companys total accounts receivable outstanding for more than one
year were approximately $370 million, of which approximately 90% related to accounts receivable in
Greece, Italy, Spain and Portugal, mostly comprised of hospital and public sector receivables.
As previously disclosed, the
Company received zero coupon bonds from the Greek government in settlement of 2007-2009 receivables related to certain
government sponsored institutions. During 2011, the Company sold a
portion of these bonds. The Company has recorded impairment charges
to reduce the remaining bonds to fair value and as of September 30, 2011, the balance was not material. During 2011, the
Company has continued to receive payments on 2011 and 2010 Greek hospital and public sector receivables; these receivables
totaled approximately $100 million as of September 30, 2011.
Derivative financial instruments are executed under International Swaps and Derivatives
Association master agreements. The master agreements with several of the Companys financial
institution counterparties also include credit support annexes. These annexes contain provisions
that require collateral to be exchanged depending on the value of the derivative assets and
liabilities, the Companys credit rating, and the credit rating of the counterparty. As of
September 30, 2011 and December 31, 2010, the Company had received cash collateral of $378 million
and $157 million, respectively, from various counterparties which is recorded in Accrued and other
current liabilities. The Company had not advanced any cash collateral to counterparties as of
September 30, 2011 or December 31, 2010.
6. Inventories
Inventories consisted of:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Finished goods |
|
$ |
1,640 |
|
|
$ |
1,484 |
|
Raw materials and work in process |
|
|
5,800 |
|
|
|
5,449 |
|
Supplies |
|
|
293 |
|
|
|
315 |
|
|
Total (approximates current cost) |
|
|
7,733 |
|
|
|
7,248 |
|
Reduction to LIFO costs |
|
|
(112 |
) |
|
|
(186 |
) |
|
|
|
$ |
7,621 |
|
|
$ |
7,062 |
|
|
Recognized as: |
|
|
|
|
|
|
|
|
Inventories |
|
$ |
6,239 |
|
|
$ |
5,868 |
|
Other assets |
|
|
1,382 |
|
|
|
1,194 |
|
|
As of September 30, 2011
and December 31, 2010, $155 million and $225 million, respectively,
of purchase accounting adjustments to inventories remained which are recognized as a component of
Materials and production costs as the related inventories are sold. Amounts recognized as Other
assets are comprised almost entirely of raw materials and work in process inventories. At
September 30, 2011 and December 31, 2010, these amounts included $1.3 billion and $1.0 billion,
respectively, of inventories not expected to be sold within one year, principally vaccines. In
addition, these amounts included $128 million and $197 million at September 30, 2011 and December
31, 2010, respectively, of inventories produced in preparation for product launches.
7. Other Intangibles
At the time of the Merger, the Company measured the fair value of Schering-Ploughs marketed
products and legacy pipeline programs and capitalized these amounts. During the first nine months
of 2011, the Company recorded an intangible asset impairment charge of $118 million within
Materials and production costs related to a marketed product. Also, during the third quarter and
first nine months of 2011, the Company recorded $22 million and $343 million, respectively, of
in-process research and development (IPR&D) impairment charges within Research and development
expenses primarily for pipeline programs that had previously been deprioritized and were either
deemed to have no alternative use in the period or were out-licensed to a third party for
consideration that was less than the related assets carrying value. During the third quarter and
first nine months of 2010, the
- 16 -
Notes
to Consolidated Financial Statements (unaudited) (continued)
Company recorded $189 million and $216 million, respectively, of
IPR&D impairment charges attributable to compounds identified during the Companys pipeline
prioritization review that were abandoned and determined to have either no alternative use or were
returned to the respective licensor, as well as from expected delays in the launch timing or
changes in cash flow assumptions for certain compounds. The Company may recognize additional
non-cash impairment charges in the future related to marketed products or for the cancellation of
other legacy Schering-Plough pipeline programs and such charges could be material.
8. Joint Ventures and Other Equity Method Affiliates
Equity income from affiliates reflects the performance of the Companys joint ventures and
other equity method affiliates and was comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
AstraZeneca LP |
|
$ |
141 |
|
|
$ |
192 |
|
|
$ |
318 |
|
|
$ |
357 |
|
Other (1) |
|
|
20 |
|
|
|
44 |
|
|
|
36 |
|
|
|
60 |
|
|
|
|
$ |
161 |
|
|
$ |
236 |
|
|
$ |
354 |
|
|
$ |
417 |
|
|
|
|
|
(1) |
|
Primarily reflects results from Sanofi Pasteur MSD, as well as Johnson & Johnson°Merck
Consumer Pharmaceuticals Company (which was divested in September 2011). |
AstraZeneca LP
In 1998, Old Merck and Astra completed the restructuring of the ownership and operations of
their existing joint venture whereby Old Merck acquired Astras interest in KBI Inc. (KBI) and
contributed KBIs operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P.
(the Partnership), in exchange for a 1% limited partner interest. Astra contributed the net
assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership in exchange for a 99%
general partner interest. The Partnership, renamed AstraZeneca LP (AZLP) upon Astras 1999 merger
with Zeneca Group Plc (the AstraZeneca merger), became the exclusive distributor of the products
for which KBI retained rights.
In connection with the 1998 restructuring, Astra purchased an option (the Asset Option) for
a payment of $443 million, which was recorded as deferred income, to buy Old Mercks interest in
the KBI products, excluding the gastrointestinal medicines Nexium and Prilosec (the Non-PPI
Products). In April 2010, AstraZeneca exercised the Asset Option. Merck received $647 million
from AstraZeneca, representing the net present value as of March 31, 2008 of projected future
pretax revenue to be received by Old Merck from the Non-PPI Products, which was recorded as a
reduction to the Companys investment in AZLP. The Company recognized the $443 million of deferred
income in the second quarter of 2010 as a component of Other (income) expense, net. In addition,
in 1998, Old Merck granted Astra an option (the Shares Option) to buy Old Mercks common stock
interest in KBI and, therefore, Old Mercks interest in Nexium and Prilosec, exercisable in 2012.
The exercise price for the Shares Option will be based on the net present value of estimated future
net sales of Nexium and Prilosec as determined at the time of exercise, subject to certain true-up
mechanisms. The Company believes that it is likely that AstraZeneca will exercise the Shares
Option.
Summarized financial information for AZLP is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Sales |
|
$ |
1,124 |
|
|
$ |
1,200 |
|
|
$ |
3,460 |
|
|
$ |
3,790 |
|
Materials and production costs |
|
|
464 |
|
|
|
605 |
|
|
|
1,524 |
|
|
|
1,864 |
|
Other expense, net |
|
|
357 |
|
|
|
224 |
|
|
|
1,004 |
|
|
|
679 |
|
|
Income before taxes (1) |
|
$ |
303 |
|
|
$ |
371 |
|
|
$ |
932 |
|
|
$ |
1,247 |
|
|
|
|
|
(1) |
|
Mercks partnership returns from AZLP are generally contractually determined and
are not based on a percentage of income from AZLP, other than with respect to the 1% limited
partnership interest discussed above. |
- 17 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Johnson & Johnson°Merck Consumer Pharmaceuticals Company
In September 2011,
Merck sold its 50% interest in the Johnson & Johnson°Merck Consumer
Pharmaceuticals Company (JJMCP) joint venture to J&J. The venture between Merck and J&J was formed
in 1989 to develop, manufacture, market and distribute certain over-the-counter (OTC) consumer
products in the United States and Canada. Merck received a one-time payment of $175 million and
recognized a pretax gain of $136 million in the third quarter of 2011 reflected in Other (income)
expense, net. Mercks rights to the Pepcid brand outside the United States and Canada were not
affected by this transaction. Following the transaction, J&J owns the ventures assets which
include the exclusive rights to market OTC Pepcid, Mylanta, Mylicon and other local OTC brands
where they are currently sold in the United States and Canada. The partnership assets also
included a manufacturing facility.
9. Contingencies and Environmental Liabilities
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. Except for the Vioxx Litigation and the
ENHANCE Litigation (each as defined below) for which separate assessments are provided in this
Note, in the opinion of the Company, it is unlikely that the resolution of these matters will be
material to the Companys financial position, results of operations or cash flows.
Given the preliminary nature of the litigation discussed below, including the Vioxx Litigation
and the ENHANCE Litigation, and the complexities involved in these matters, the Company is unable
to reasonably estimate a possible loss or range of possible loss for such matters until the Company
knows, among other factors, (i) what claims, if any, will survive dispositive motion practice,
(ii) the extent of the claims, including the size of any potential class, particularly when damages
are not specified or are indeterminate, (iii) how the discovery process will affect the litigation,
(iv) the settlement posture of the other parties to the litigation and (v) any other factors that
may have a material effect on the litigation.
Vioxx Litigation
Product Liability Lawsuits
As previously disclosed, individual and putative class actions have been filed against Old
Merck in state and federal courts alleging personal injury and/or economic loss with respect to the
purchase or use of Vioxx. Most of the cases that remain are coordinated in a multidistrict
litigation in the U.S. District Court for the Eastern District of Louisiana (the Vioxx MDL)
before District Judge Eldon E. Fallon. (All of the actions discussed in this paragraph and in
Other Lawsuits below are collectively referred to as the Vioxx Product Liability Lawsuits.)
Of the plaintiff groups in the Vioxx Product Liability Lawsuits described above, the vast
majority were dismissed as a result of the Vioxx Settlement Program, which has been described
previously. As of September 30, 2011, approximately 25 plaintiff groups who were otherwise
eligible for the Settlement Program did not participate and their claims remain pending against Old
Merck. In addition, the claims of approximately 75 plaintiff groups who were not eligible for the
Settlement Program remain pending against Old Merck.
There are no U.S. Vioxx Product Liability Lawsuits currently scheduled for trial in 2011. Old
Merck has previously disclosed the outcomes of several Vioxx Product Liability Lawsuits that were
tried prior to 2010. Of the cases that went to trial, there is only one unresolved post-trial
appeal: Ernst v. Merck. Merck has previously disclosed the details associated with the Ernst case
and the grounds for Mercks appeal. On August 26, 2011, the Texas Supreme Court reversed the
judgment of the Court of Appeals in Garza, and rendered judgment for Merck.
- 18 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Other Lawsuits
There are still pending in various U.S. courts putative class actions purportedly brought on
behalf of individual purchasers or users of Vioxx seeking reimbursement for alleged economic loss.
In the Vioxx MDL proceeding, approximately 30 such class actions remain. In June 2010, Old Merck
moved to strike the class claims or for judgment on the pleadings regarding the master complaint,
which includes the above-referenced cases, and briefing on that motion was completed in September
2010. The Vioxx MDL court heard oral argument on Old Mercks motion in October 2010 and took it
under advisement.
In June 2008, a Missouri state court certified a class of Missouri plaintiffs seeking
reimbursement for out-of-pocket costs relating to Vioxx. Trial is scheduled to begin on May 21,
2012. In addition, in Indiana, plaintiffs have filed a motion to certify a class of Indiana Vioxx
purchasers in a case pending before the Circuit Court of Marion County, Indiana. In April 2010, a
Kentucky state court denied Old Mercks motion for summary judgment and certified a class of
Kentucky plaintiffs seeking reimbursement for out-of-pocket costs relating to Vioxx. The Kentucky
Court of Appeals denied Old Mercks petition for a writ of mandamus, and the Kentucky Supreme Court
has affirmed that ruling. The trial court entered an amended class certification order on January
27, 2011, and Merck has appealed that ruling to the Kentucky Court of Appeals. Oral argument on
the appeal is currently scheduled for November 14, 2011, although plaintiff has requested a
continuance.
Old Merck has also been named as a defendant in several lawsuits brought by, or on behalf of,
government entities. Twelve of these suits are being brought by state Attorneys General and one has
been brought on behalf of a county. All of these actions, except for a suit brought by the
Attorney General of Michigan, are in the Vioxx MDL proceeding. The Michigan Attorney General case
was remanded to state court. The trial court denied Old Mercks motion to dismiss, but the Court
of Appeals reversed that ruling on March 17, 2011, ordering the trial court to dismiss the case.
The Michigan Attorney General sought review before the Michigan Supreme Court, but its petition was
denied on September 30, 2011. These actions allege that Old Merck misrepresented the safety of
Vioxx. All but one of these suits seek recovery for expenditures on Vioxx by government-funded
health care programs such as Medicaid, along with other relief such as penalties and attorneys
fees. An action brought by the Attorney General of Kentucky seeks only penalties for alleged
Consumer Fraud Act violations. The Attorney General of Kentucky has moved to remand that case to
state court, and the MDL court heard oral argument on the motion on August 31, 2011. The lawsuit
brought by the county is a class action filed by Santa Clara County, California on behalf of all
similarly situated California counties. Old Merck moved to dismiss the case brought by the
Attorney General of Oklahoma in December 2010 and for judgment on the pleadings in the case brought
by Santa Clara County in September 2011.
In March 2010, Judge Fallon partially granted and partially denied Old Mercks motion for
summary judgment in the Louisiana Attorney General case. A trial on the remaining claims before
Judge Fallon was completed in April 2010 and Judge Fallon found in favor of Old Merck in June 2010
dismissing the Louisiana Attorney Generals remaining claims with prejudice. The Louisiana Attorney General
filed a notice of appeal, and the Fifth Circuit dismissed the appeal without prejudice pursuant to
its scheduling rules on October 21, 2011 after the Louisiana Attorney General requested a stay of the appeal.
Shareholder Lawsuits
As previously disclosed, in addition to the Vioxx Product Liability Lawsuits, various putative
class actions and individual lawsuits under federal and state securities laws have been filed
against Old Merck and various current and former officers and directors (the Vioxx Securities
Lawsuits). As previously disclosed, the Vioxx Securities Lawsuits have been transferred by the
Judicial Panel on Multidistrict Litigation (the JPML) to the U.S. District Court for the District
of New Jersey before District Judge Stanley R. Chesler for inclusion in a nationwide MDL (the
Shareholder MDL), and have been consolidated for all purposes. In June 2010, Old Merck moved to
dismiss the Fifth Amended Class Action Complaint in the consolidated securities action. Oral
argument on the motion to dismiss was held on July 12, 2011. On August 8, 2011, Judge Chesler
granted in part and denied in part the motion to dismiss. Among other things, the claims based on
statements made on or after the voluntary withdrawal of Vioxx on September 30, 2004 have been
dismissed. On October 7, 2011, defendants answered the Fifth Amended Class Action Complaint.
- 19 -
Notes to Consolidated Financial Statements (unaudited) (continued)
As previously disclosed, several individual securities lawsuits filed by foreign institutional
investors also are consolidated with the Vioxx Securities Lawsuits. By stipulation, defendants
were not required to respond to these complaints until the resolution of any motions to dismiss in
the consolidated securities class action. On October 7, 2011, the court entered as an order a
stipulation previously submitted by the parties requiring plaintiffs to file amended complaints in
each of the individual securities lawsuits by October 21, 2011. Under the order, defendants have
until January 20, 2012 to file motions to dismiss in one of the individual lawsuits (the ABP
Lawsuit). The time to move or otherwise respond to the complaints in the remaining individual
securities lawsuits is stayed until 45 days after the resolution of any motions to dismiss in the
ABP Lawsuit.
In addition, as previously disclosed, various putative class actions have been filed in
federal court under the Employee Retirement Income Security Act (ERISA) against Old Merck and
certain current and former officers and directors (the Vioxx ERISA Lawsuits). Those cases were
consolidated in the Shareholder MDL before Judge Chesler. Fact discovery in the Vioxx ERISA
Lawsuits closed in September 2010 and expert discovery closed in May 2011. In June 2011,
Old Merck filed a motion for summary judgment, and plaintiffs filed a motion for partial summary
judgment. As previously disclosed, in February 2009, the court denied the motion for class
certification as to one count, and granted the motion as to the remaining counts in Consolidated
Amended Complaint in the Vioxx ERISA Lawsuits. On August 16, 2011, while motions for renewed class
certifications and summary judgment were pending but not yet decided, the parties reached an
agreement in principle in which Merck would pay $49.5 million to settle the Vioxx ERISA Lawsuits.
On August 17, 2011, Merck requested a stay of all proceedings to
allow the parties to document and seek approval of the proposed settlement. On August 19, 2011, the court granted the parties
request for a stay, and on August 25, 2011, in light of the proposed settlement, the court
dismissed without prejudice all pending motions. On September 20, 2011, plaintiffs filed an
unopposed motion for preliminary approval of the settlement and approval of notice plan. On
October 6, 2011, the court entered an order preliminarily approving the proposed settlement. The
court has scheduled a final approval hearing on the settlement for November 29, 2011.
International Lawsuits
As previously disclosed, in addition to the lawsuits discussed above, Old Merck has been named
as a defendant in litigation relating to Vioxx in Australia, Brazil, Canada, Europe and Israel
(collectively, the Vioxx Foreign Lawsuits).
Following trial of a representative action in 2009, a first instance judge of the Federal
Court in Australia entered orders in 2010 which dismissed all claims against Old Merck. With regard
to Old Mercks Australian subsidiary, Merck Sharp & Dohme (Australia) Pty Ltd, the court dismissed
certain claims but awarded the applicant, whom the court found suffered a myocardial infarction (MI) after ingesting Vioxx
for approximately 33 months, AU $330,465 based on statutory claims that Vioxx was not fit for
purpose or of merchantable quality, even though the court rejected the applicants claim that Old
Merck and its Australian subsidiary knew or ought to have known prior to the voluntary withdrawal
of Vioxx in September 2004 that Vioxx materially increased the risk of MI. The court also
determined which of its findings of fact and law were common to the claims of other group members
whose individual claims would proceed with reference to those findings. Old Mercks subsidiary
appealed the adverse findings and the Full Federal Court (the Full Court) heard the appeal and a
cross-appeal in August 2011. In October 2011, the Full Court allowed Old Mercks subsidiarys
appeal and set aside the judgment in favor of the applicant and dismissed his action. The Full
Court held that Vioxx was not proven to be the cause of the applicants MI and
that Old Mercks subsidiary is not liable to the applicant for damages in negligence or under the
former Trade Practices Act. The Full Court also affirmed the first instance decision in favor of
Old Mercks subsidiary on the applicants statutory defect claim, holding that Old Mercks
subsidiarys state of the art defense was proven based on the development of scientific knowledge
over time. The effect of this decision upon the claims of the remaining group members remains to
be determined.
- 20 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Insurance
The Company has Directors and Officers insurance coverage applicable to the Vioxx Securities
Lawsuits with remaining stated upper limits of approximately $175 million. The Company has
Fiduciary and other insurance for the Vioxx ERISA Lawsuits with stated upper limits of
approximately $275 million. As a result of the previously disclosed insurance arbitration,
additional insurance coverage for these claims should also be available, if needed, under
upper-level excess policies that provide coverage for a variety of risks. There are disputes with
the insurers about the availability of some or all of the Companys insurance coverage for these
claims and there are likely to be additional disputes. The amounts actually recovered under the
policies discussed in this paragraph may be less than the stated upper limits.
Investigations
As previously disclosed, Old Merck has received subpoenas from the Department of Justice
(DOJ) requesting information related to Old Mercks research, marketing and selling activities
with respect to Vioxx in a federal health care investigation under criminal statutes. This
investigation included subpoenas for witnesses to appear before a grand jury. As previously
disclosed, in March 2009, Old Merck received a letter from the U.S. Attorneys Office for the
District of Massachusetts identifying it as a target of the grand jury investigation regarding
Vioxx. In the third quarter of 2010, the Company established a $950 million reserve (the Vioxx
Liability Reserve) in connection with the anticipated resolution of the DOJs investigation. The
Companys discussions with the government are ongoing. Until they are concluded, there can be no
certainty about a definitive resolution. The Company is cooperating with the DOJ in its
investigation (the Vioxx Investigation). The Company cannot predict the outcome of these
inquiries; however, they could result in potential civil and/or criminal remedies.
Reserves
There are no U.S. Vioxx Product Liability Lawsuits currently scheduled for trial in 2011. A
trial in the Missouri state court action is scheduled to begin on May 21, 2012. The Company cannot
predict the timing of any other trials related to the Vioxx Litigation. The Company believes that
it has meritorious defenses to the Vioxx Product Liability Lawsuits, Vioxx Shareholder Lawsuits and
Vioxx Foreign Lawsuits (collectively, the Vioxx Lawsuits) and will vigorously defend against
them. In view of the inherent difficulty of predicting the outcome of litigation, particularly
where there are many claimants and the claimants seek indeterminate damages, the Company is unable
to predict the outcome of these matters, and at this time cannot reasonably estimate the possible
loss or range of loss with respect to the Vioxx Lawsuits not included in the Settlement Program.
Unfavorable outcomes in the Vioxx Litigation could have a material adverse effect on the Companys
financial position, liquidity and results of operations.
Legal defense costs expected to be incurred in connection with a loss contingency are accrued
when probable and reasonably estimable. As of December 31, 2010, the Company had an aggregate
reserve of approximately $76 million (the Vioxx Legal Defense Costs Reserve) solely for future
legal defense costs related to the Vioxx Litigation.
During the first nine months of 2011, the Company spent approximately $61 million in the
aggregate, including $24 million in the third quarter, in legal defense costs worldwide related to
(i) the Vioxx Product Liability Lawsuits, (ii) the Vioxx Shareholder Lawsuits, (iii) the Vioxx
Foreign Lawsuits, and (iv) the Vioxx Investigation (collectively, the Vioxx Litigation). In
addition, in the first nine months of 2011, the Company recorded charges of $49 million solely for
its future legal defense costs for the Vioxx Litigation, including $30 million in the third
quarter. Consequently, as of September 30, 2011, the aggregate amount of the Vioxx Legal Defense
Costs Reserve was approximately $64 million, which is solely for future legal defense costs for the
Vioxx Litigation. Some of the significant factors considered in the review of the Vioxx Legal
Defense Costs Reserve were as follows: the actual costs incurred by the Company; the development of
the Companys legal defense strategy and structure in light of the scope of the Vioxx Litigation,
including the Settlement Agreement and the lawsuits that are continuing; the number of cases being
brought against the Company; the costs and outcomes of completed trials and the most current
information regarding anticipated timing, progression, and related costs of pre-trial activities
and trials in the Vioxx Litigation. The amount of the Vioxx Legal Defense Costs Reserve as of
September 30, 2011 represents the Companys best estimate of the minimum amount of defense costs to
be incurred in connection with the remaining aspects of the Vioxx Litigation; however, events such
as additional trials in the Vioxx Litigation and other events that could arise in the course of the
Vioxx Litigation could affect the ultimate amount of defense costs to be incurred by the Company.
The Company will continue to monitor its legal defense costs and review the adequacy of the
associated reserves and may determine to increase the Vioxx Legal Defense Costs Reserve at any time
in the future if, based upon the factors set forth, it believes it would be appropriate to do so.
- 21 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Other Product Liability Litigation
Fosamax
As previously disclosed, Old Merck is a defendant in product liability lawsuits in the United
States involving Fosamax (the Fosamax Litigation). As of September 30, 2011, approximately 2,000
cases, which include approximately 2,420 plaintiff groups, had been filed and were pending against
Old Merck in either federal or state court, including one case which seeks class action
certification, as well as damages and/or medical monitoring. In approximately 1,160 of these
actions, plaintiffs allege, among other things, that they have suffered osteonecrosis of the jaw
(ONJ), generally subsequent to invasive dental procedures, such as tooth extraction or dental
implants and/or delayed healing, in association with the use of Fosamax. In addition, plaintiffs
in approximately 840 of these actions generally allege that they sustained femur fractures and/or
other bone injuries in association with the use of Fosamax.
Cases Alleging ONJ and/or Other Jaw Related Injuries
In August 2006, the JPML ordered that certain Fosamax product liability cases pending in
federal courts nationwide should be transferred and consolidated into one multidistrict litigation
(the Fosamax MDL) for coordinated pre-trial proceedings. The Fosamax MDL has been transferred to
Judge John Keenan in the U.S. District Court for the Southern District of New York. As a result of
the JPML order, approximately 940 of the cases are before Judge Keenan. Judge Keenan issued a Case
Management Order (and various amendments thereto) which set forth a schedule governing the
proceedings focused primarily upon resolving the class action certification motions in 2007 and
completing fact discovery in an initial group of 25 cases by October 1, 2008. In the first Fosamax
MDL trial, Boles v. Merck, the Fosamax MDL court declared a mistrial because the eight person jury
could not reach a unanimous verdict. The Boles case was retried in June 2010 and resulted in a
verdict in favor of the plaintiff in the amount of $8 million. Merck filed post-trial motions
seeking judgment as a matter of law or, in the alternative, a new trial. In October 2010, the
court denied Mercks post-trial motions but sua sponte ordered a remittitur, reducing the verdict
to $1.5 million. Plaintiff rejected the remittitur ordered by the court and requested a new trial
on damages, which is scheduled to take place on March 26, 2012. Merck intends to appeal the
verdict in Boles after the new trial on damages has concluded.
In the next Fosamax MDL trial, Maley v. Merck, the jury in May 2010 returned a unanimous
verdict in Mercks favor. In February 2010, Judge Keenan selected a new bellwether case, Judith
Graves v. Merck, to replace the Flemings v. Merck bellwether case, which the Fosamax MDL court dismissed
when it granted summary judgment in favor of Old Merck. In November 2010, the Second Circuit
affirmed the courts granting of summary judgment in favor of Old Merck in the Flemings case. In
Graves, the jury returned a unanimous verdict in favor of Old Merck in November 2010. The jury in
Secrest v. Merck returned a unanimous verdict in favor of Old Merck in October 2011.
The next trial scheduled in the Fosamax MDL was Raber v. Merck, which was subsequently dismissed. In
addition, in February 2011, Judge Keenan ordered that there will be two further bellwether trials
conducted in the Fosamax MDL: Spano v. Merck is
scheduled to be tried on September 10, 2012;
Jellema v. Merck is scheduled to be tried on May 7, 2012, though Jellemas counsel has advised that he will seek to dismiss the case.
Outside the Fosamax MDL, a trial in Florida, Anderson v. Merck, was scheduled to begin in June
2010 but the Florida state court postponed the trial date and a new date has been set for March 5,
2012. The trial ready date in Carballo v. Merck has been continued from August 22, 2011 until
April 30, 2012. The Ward v. Merck case is scheduled to be tried on June 11, 2012.
In addition, in July 2008, an application was made by the Atlantic County Superior Court of
New Jersey requesting that all of the Fosamax cases pending in New Jersey be considered for mass
tort designation and centralized management before one judge in New Jersey. In October 2008, the
New Jersey Supreme Court ordered that all pending and future actions filed in New Jersey arising
out of the use of Fosamax and seeking damages for existing dental and jaw-related injuries,
including ONJ, but not solely seeking medical monitoring, be designated as a mass tort for
centralized management purposes before Judge Carol E. Higbee in Atlantic County Superior Court. As
of September 30, 2011, approximately 210 ONJ cases were pending against Old Merck in Atlantic
County, New Jersey. In July 2009, Judge Higbee entered a Case Management Order (and various
amendments thereto) setting forth a schedule that contemplates completing fact and expert discovery
in an initial group of cases to be reviewed for trial. On February 14, 2011, the jury in Rosenberg
v. Merck, the first trial in the New Jersey coordinated proceeding, returned a verdict in Mercks
favor. A trial in the Rifkin v. Merck, Flores v. Merck and Sessner v. Merck cases is scheduled for
February 27, 2012.
- 22 -
Notes to Consolidated Financial Statements (unaudited) (continued)
In California, the parties are reviewing the claims of three plaintiffs in the Carrie Smith,
et al. v. Merck case and the claims in Pedrojetti v. Merck. The cases of one or more of these
plaintiffs are expected to be tried in mid-2012.
Discovery is ongoing in the Fosamax MDL litigation, the New Jersey coordinated proceeding, and
the remaining jurisdictions where Fosamax cases are pending. The Company intends to defend against
these lawsuits.
Cases Alleging Femur Fractures and/or Other Bone Injuries
As of September 30, 2011, approximately 645 cases alleging femur fractures and/or other bone
injuries have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic
County Superior Court. The parties have selected an initial group of 30 cases to be reviewed
through fact discovery. A Case Management Order setting forth a discovery and motions schedule
with respect to these cases is expected but has not yet been entered and no trial
dates for any of the New Jersey state femur fracture cases have been set.
In March 2011, Merck submitted a Motion to Transfer to the JPML seeking to have all
federal cases alleging femur fractures and other bone injuries consolidated into one multidistrict
litigation for coordinated pre-trial proceedings. The Motion to Transfer was granted in May
2011, and all federal cases involving allegations of femur fracture or other bone injuries have
been or will be transferred to the District of New Jersey where the Fosamax MDL is sited. Judge
Garrett Brown has been assigned to preside over this second Fosamax MDL proceeding. A Case
Management Order has been entered by Judge Brown that requires the parties to review 40 cases with
a fact discovery deadline of July 31, 2012, an expert discovery deadline of November 28, 2012, and
a projected trial date for the first case to be tried sometime after March 1, 2013.
A petition was filed seeking to coordinate all femur fracture cases filed in California state
court before a single judge in Orange County, California. The petition was granted and Judge
Ronald L. Bauer will preside over the coordinated proceedings. No scheduling order has yet been
entered.
Additionally, there are three femur fracture cases pending in other state courts. One case is
pending in Massachusetts, one is pending in Florida, and one is pending in Alabama.
Discovery is ongoing in the federal and state courts where femur fracture cases are pending
and the Company intends to defend against these lawsuits.
NuvaRing
Beginning in May 2007, a number of complaints were filed in various jurisdictions asserting
claims against the Companys subsidiaries Organon USA, Inc., Organon Pharmaceuticals USA, Inc.,
Organon International (collectively, Organon), and Schering-Plough arising from Organons
marketing and sale of NuvaRing, a combined hormonal contraceptive vaginal ring. The plaintiffs
contend that Organon and Schering-Plough, among other things, failed to adequately design and
manufacture NuvaRing and failed to adequately warn of the alleged increased risk of venous
thromboembolism (VTE) posed by NuvaRing, and/or downplayed the risk of VTE. The plaintiffs seek
damages for injuries allegedly sustained from their product use, including some alleged deaths,
heart attacks and strokes. The majority of the cases are currently pending in a federal
multidistrict litigation (the NuvaRing MDL) venued in Missouri and in a coordinated proceeding in
New Jersey state court.
As of September 30, 2011, there were approximately 900 NuvaRing cases. Of these cases,
approximately 775 are or will be pending in the NuvaRing MDL in the U.S. District Court for the
Eastern District of Missouri before Judge Rodney Sippel, and approximately 120 are pending in
consolidated discovery proceedings in the Bergen County Superior Court of New Jersey before Judge
Brian R. Martinotti. Four additional cases are pending in various other state courts.
Pursuant to orders of Judge Sippel in the NuvaRing MDL, the parties originally selected a pool
of more than twenty cases to prepare for trial and that pool has since been narrowed to eight cases
from which the first trials in the NuvaRing MDL will be selected. Pursuant to Judge Martinottis
order in the New Jersey proceeding, the parties selected ten trial pool cases to be prepared for
trial. The parties have completed fact discovery in the originally selected trial pool cases in
each jurisdiction and the Company anticipates expert discovery to be completed in the Spring of
2012. Certain of the cases in the original trial pool have been voluntarily dismissed and in one
case judgment was entered in Mercks favor and, as a result, certain replacement trial pool cases
remain in fact discovery.
- 23 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The Company anticipates that status conferences will be held in each coordinated proceeding
following the completion of expert discovery to determine a methodology for selecting the first
cases to be tried. The Company intends to defend against these lawsuits.
Propecia/Proscar
Merck has been
sued this year in approximately 60 lawsuits involving a total of approximately
100 plaintiffs (in a few instances spouses are joined in the suits) who allege that they have
experienced persistent sexual side effects following cessation of treatment with Propecia and/or
Proscar. The lawsuits, which are in their early stages, are pending in federal courts in New
Jersey, Washington, Washington D.C. and Florida, and in state court in New Jersey. The
Company intends to defend against these lawsuits.
Governmental Proceedings
Merck has received a Civil
Investigative Demand (CID) issued by the DOJ addressed to
Inspire Pharmaceuticals, Inc., a company acquired by Merck in May 2011. The CID advises
that it relates to a False
Claims Act investigation concerning allegations that Inspire caused the submission of false claims
to federal health benefits programs for the drug AzaSite by marketing it for the treatment of
indications not approved by the U.S. Food and Drug
Administration (the FDA). The Company is
cooperating with the government in its investigation and cannot predict the outcome of this
inquiry.
The Company has received a subpoena from the DOJ requesting information relating to the
Companys marketing and selling activities with respect to Integrilin and Avelox, from January 2003
to June 2010, in a civil federal health care investigation. The Company is cooperating with the
DOJs investigation.
Vytorin/Zetia Litigation
As previously disclosed, in April 2008, an Old Merck shareholder filed a putative class action
lawsuit in federal court in the Eastern District of Pennsylvania alleging that Old Merck violated
the federal securities laws. This suit has since been withdrawn and re-filed in the District of
New Jersey and has been consolidated with another federal securities lawsuit under the caption In
re Merck & Co., Inc. Vytorin Securities Litigation. An amended consolidated complaint was filed in
October 2008, and names as defendants Old Merck; Merck/Schering-Plough Pharmaceuticals, LLC; and
certain of the Companys current and former officers and directors. Specifically, the complaint
alleges that Old Merck delayed releasing unfavorable results of the ENHANCE clinical trial
regarding the efficacy of Vytorin and that Old Merck made false and misleading statements about
expected earnings, knowing that once the results of the Vytorin study were released, sales of
Vytorin would decline and Old Mercks earnings would suffer. In December 2008, Old Merck and the
other defendants moved to dismiss this lawsuit on the grounds that the plaintiffs failed to state a
claim for which relief can be granted. In September 2009, the court issued an opinion and order
denying the defendants motion to dismiss this lawsuit and, in October 2009, Old Merck and the
other defendants filed an answer to the amended consolidated complaint. There is a similar
consolidated, putative class action securities lawsuit pending in the District of New Jersey, filed
by a Schering-Plough shareholder against Schering-Plough and its former Chairman, President and
Chief Executive Officer, Fred Hassan, under the caption In re Schering-Plough Corporation/ENHANCE
Securities Litigation. The amended consolidated complaint was filed in September 2008 and names as
defendants Schering-Plough; Merck/Schering-Plough Pharmaceuticals, LLC; certain of the Companys
current and former officers and directors; and underwriters who participated in an August 2007
public offering of Schering-Ploughs common and preferred stock. In December 2008, Schering-Plough
and the other defendants filed motions to dismiss this lawsuit on the grounds that the plaintiffs
failed to state a claim for which relief can be granted. In September 2009, the court issued an
opinion and order denying the defendants motion to dismiss this lawsuit. The defendants filed an
answer to the consolidated amended complaint in November 2009.
As previously disclosed, in April 2008, a member of an Old Merck ERISA plan filed a putative
class action lawsuit against Old Merck and certain of the Companys current and former officers and
directors alleging they breached their fiduciary duties under ERISA. Since that time, there have
been other similar ERISA lawsuits filed against Old Merck in the District of New Jersey, and all of
those lawsuits have been consolidated under the caption In re Merck & Co., Inc. Vytorin ERISA
Litigation. A consolidated amended complaint was filed in February 2009, and names as defendants
Old Merck and various current and former members of the Companys Board of Directors. The
plaintiffs allege that the ERISA plans investment in Old Merck stock was imprudent because Old
Mercks earnings are dependent on the commercial success of its cholesterol drug Vytorin and that
defendants knew or should have known that the results of a scientific study would cause the medical
community to turn to less expensive drugs for cholesterol management. In April 2009, Old Merck and
the other defendants moved to dismiss this lawsuit on the grounds that the plaintiffs failed to
state a claim for which relief can be granted. In September 2009, the court issued an opinion and
order denying the defendants motion to dismiss this lawsuit. In November 2009, the plaintiffs
moved to strike certain of the defendants affirmative defenses. That motion was denied in part
and granted in part in June 2010, and an amended answer was filed in July 2010.
- 24 -
Notes to Consolidated Financial Statements (unaudited) (continued)
There is a similar consolidated, putative class action ERISA lawsuit currently pending in the
District of New Jersey, filed by a member of a Schering-Plough ERISA plan against Schering-Plough
and certain of its current and former officers and directors, alleging they breached their
fiduciary duties under ERISA, and under the caption In re Schering-Plough Corp. ENHANCE ERISA
Litigation. The consolidated amended complaint was filed in October 2009 and names as defendants
Schering-Plough, various current and former members of Schering-Ploughs Board of Directors and
current and former members of committees of Schering-Ploughs Board of Directors. In November
2009, the Company and the other defendants filed a motion to dismiss this lawsuit on the grounds
that the plaintiffs failed to state a claim for which relief can be granted. The plaintiffs
opposition to the motion to dismiss was filed in December 2009, and the motion was fully briefed in
January 2010. That motion was denied in June 2010. In September 2010, defendants filed an answer
to the amended complaint in this matter.
In November 2009, a stockholder of the Company filed a shareholder derivative lawsuit, In re
Local No. 38 International Brotherhood of Electrical Workers Pension Fund v. Clark (Local No.
38), in the District of New Jersey, on behalf of the nominal defendant, the Company, and all
shareholders of the Company, against the Company; certain of the Companys officers, directors and
alleged insiders; and certain of the predecessor companies former officers, directors and alleged
insiders for alleged breaches of fiduciary duties, waste, unjust enrichment and gross
mismanagement. A similar shareholder derivative lawsuit, Cain v. Hassan, was filed by a
Schering-Plough stockholder and is currently pending in the District of New Jersey. An amended
complaint was filed in May 2008, by the Schering-Plough stockholder on behalf of the nominal
defendant, Schering-Plough, and all Schering-Plough shareholders. The lawsuit is against the
Company, Schering-Ploughs then-current Board of Directors, and certain of Schering-Ploughs
current and former officers, directors and alleged insiders. The plaintiffs in both Local No. 38
and Cain v. Hassan alleged that the defendants withheld the ENHANCE study results and made false
and misleading statements, thereby deceiving and causing harm to the Company and Schering-Plough,
respectively, and to the investing public, unjustly enriching insiders and wasting corporate
assets. The plaintiff in Local No. 38 voluntarily dismissed the suit without prejudice in July
2011. The intervenor-plaintiff in Cain v. Hassan filed a second amended complaint in July 2011.
The defendants moved to dismiss the second amended complaint on October 13, 2011. On October 14,
2011, the parties reached an agreement in principle to settle the case, subject to approval by a
committee of Mercks Board of Directors and the court. On October 18, 2011, the court stayed all
discovery in the action. In November 2010, a Company shareholder filed a derivative lawsuit in
state court in New Jersey. This case, captioned Rose v. Hassan, asserts claims that are
substantially identical to the claims alleged in Cain v. Hassan. On April 29, 2011, the defendants
in Rose v. Hassan moved to stay the case or to dismiss it without prejudice in favor of the federal
derivative action. On August 9, 2011, the New Jersey state court dismissed Rose v. Hassan without
prejudice. On September 21, 2011, the plaintiff in Rose v. Hassan filed a notice of appeal.
Discovery in the federal lawsuits referred to in this section (collectively, the ENHANCE
Litigation) has been coordinated. The Company believes that it has meritorious defenses to the
ENHANCE Litigation and intends to vigorously defend against these lawsuits. 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 ENHANCE Litigation. Unfavorable outcomes resulting from
the ENHANCE Litigation could have a material adverse effect on the Companys financial position,
liquidity and results of operations.
Insurance
The Company has Directors and Officers insurance coverage applicable to the Vytorin
shareholder lawsuits with stated upper limits of approximately $250 million. The Company has
Fiduciary and other insurance for the Vytorin ERISA lawsuits with stated upper limits of
approximately $265 million. There are disputes with the insurers about the availability of some or
all of the Companys insurance coverage for these claims and there are likely to be additional
disputes. The amounts actually recovered under the policies discussed in this paragraph may be
less than the stated limits.
Commercial Litigation
AWP Litigation and Investigations
As previously disclosed, the Company and/or certain of its subsidiaries remain defendants in
cases brought by various states alleging manipulation by pharmaceutical manufacturers of Average
Wholesale Prices (AWP), which are sometimes used by public and private payors in calculating
provider reimbursement levels. The outcome of these lawsuits could include substantial damages,
the imposition of substantial fines and penalties and injunctive or administrative remedies. In
September 2010, a jury in the U.S. District Court for the District of Massachusetts found the
Company liable on the ground that units of Schering-Plough caused Massachusetts to overpay
pharmacists for prescriptions of albuterol. The District Court held that Massachusetts should be
awarded approximately $13.8 million in treble damages and penalties, together with prejudgment
interest and attorneys fees. The Company is planning to appeal the verdict and expects Massachusetts to seek substantially
higher penalties on appeal.
- 25 -
Notes to Consolidated Financial Statements (unaudited) (continued)
During 2011, the Company has settled AWP cases brought by the states of Utah, South Carolina,
Alaska, Idaho, Kentucky, Pennsylvania, Mississippi, Wisconsin, Iowa, and certain New York counties.
The Company and/or certain of its subsidiaries continue to be defendants in cases brought by 11
states.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file Abbreviated New Drug
Applications (ANDAs) with the FDA seeking to market generic forms of the Companys products prior
to the expiration of relevant patents owned by the Company. To protect its patent rights the
Company may file patent infringement lawsuits against such generic companies. Certain products of
the Company (or marketed via agreements with other companies) currently involved in such patent
infringement litigation in the United States include: AzaSite, Cancidas, Integrilin, Nasonex,
Nexium, Noxafil, Propecia, Temodar, Vytorin and Zetia. Similar lawsuits defending the Companys
patent rights may exist in other countries. The Company intends to vigorously defend its patents,
which it believes are valid, against infringement by generic companies attempting to market
products prior to the expiration of such patents. As with any litigation, there can be no
assurance of the outcomes, which, if adverse, could result in significantly shortened periods of
exclusivity for these products.
AzaSite In May 2011, a patent infringement suit was filed in the United States against
Sandoz Inc. (Sandoz) in respect of Sandozs application to the FDA seeking pre-patent expiry
approval to market a generic version of AzaSite. The lawsuit automatically stays FDA approval of
Sandozs ANDA until October 2013 or until an adverse court decision, if any, whichever may occur
earlier.
Cancidas In November 2009, a patent infringement lawsuit was filed in the United States
against Teva Parenteral Medicines, Inc. (TPM) in respect of TPMs application to the FDA seeking
pre-patent expiry approval to sell a generic version of Cancidas. That lawsuit has been dismissed
with no rights granted to TPM. Also, in March 2010, a patent infringement lawsuit was filed in the
United States against Sandoz in respect of Sandozs application to the FDA seeking pre-patent
expiry approval to sell a generic version of Cancidas. In June 2011, Sandoz amended its challenge
to Mercks Cancidas patents stating that it did not seek FDA approval any earlier than the expiry
of a patent which occurs on July 26, 2015, but Sandoz did maintain its challenge to a Cancidas
patent which expires on September 28, 2017. Therefore, the lawsuit will continue, however, the FDA
cannot approve Sandozs application any earlier than July 26, 2015.
Integrilin In February 2009, a patent infringement lawsuit was filed (jointly with
Millennium Pharmaceuticals, Inc.) in the United States against TPM in respect of
TPMs application to the FDA seeking approval to sell a generic version of Integrilin prior to the
expiry of the last to expire listed patent. In October 2011, the parties entered a settlement
agreement allowing TPM to sell a generic version of Integrilin beginning June 2, 2015.
Nasonex In December 2009, a patent infringement suit was filed in the United States against
Apotex Corp. (Apotex) in respect of Apotexs application to the FDA seeking pre-patent expiry
approval to market a generic version of Nasonex. The lawsuit automatically stays FDA approval of
Apotexs ANDA until May 2012 or until an adverse court decision, if any, whichever may occur
earlier.
Nexium In November 2005, a patent infringement lawsuit was filed (jointly with AstraZeneca)
in the United States against Ranbaxy Laboratories Ltd. (Ranbaxy) in respect of Ranbaxys
application to the FDA seeking pre-patent expiry approval to sell a generic version of Nexium. As
previously disclosed, AstraZeneca, Merck and Ranbaxy entered into a settlement agreement which
provided that Ranbaxy will be entitled to bring its generic esomeprazole product to market in the
United States on May 27, 2014. The Company and AstraZeneca each received a Civil Investigative
Demand (CID) from the Federal Trade Commission (FTC) in July 2008 regarding the settlement
agreement with Ranbaxy. The Company is cooperating with the FTC in responding to this CID. In
March 2006, a patent infringement lawsuit was filed (jointly with AstraZeneca) against IVAX
Pharmaceuticals, Inc. (IVAX) (later acquired by Teva Pharmaceuticals, Inc. (Teva)), in respect
of IVAXs application to the FDA seeking pre-patent expiry approval to sell a generic version of
Nexium. In January 2010, AstraZeneca, Merck and Teva/IVAX entered into a settlement agreement
which provides that Teva/IVAX will be entitled to bring its generic esomeprazole product to market
in the United States on May 27, 2014. Patent infringement lawsuits have also been filed in the
United States against Dr. Reddys Laboratories (Dr. Reddys), Sandoz and Lupin Ltd. (Lupin) in
respect to their respective applications to the FDA seeking pre-patent expiry approval to sell
generic versions of Nexium. In January 2011, AstraZeneca, Merck and Dr. Reddys entered into a
settlement agreement which provides that Dr. Reddys will be entitled to bring its generic
esomeprazole product to market in the United States on May 27, 2014. In June 2011, AstraZeneca,
Merck and Sandoz entered into a settlement agreement which provides that
- 26 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Sandoz will be entitled to
bring its generic esomeprazole product to market in the United States on May 27, 2014. The lawsuit
against Lupin is ongoing with no trial dates presently scheduled. In February 2011, a patent
infringement lawsuit was filed (jointly with AstraZeneca) in the United States against Hamni
USA, Inc. (Hamni) in respect of Hamnis application to the FDA seeking pre-patent expiry approval
to sell a generic version of Nexium. A patent infringement lawsuit was also filed (jointly with
AstraZeneca) in February 2010 in the United States against Sun Pharma Global Fze (Sun Pharma) in
respect of its application to the FDA seeking pre-patent expiry approval to sell a generic version
of Nexium IV. In October 2011, AstraZeneca, Merck and Sun Pharma entered into a settlement
agreement which provides that Sun Pharma will be entitled to bring its generic esomeprazole IV
product to market in the United States on January 1, 2014.
Noxafil In May 2011, a patent infringement suit was filed in the United States against
Sandoz in respect of Sandozs application to the FDA seeking pre-patent expiry approval to market a
generic version of Noxafil. The lawsuit automatically stays FDA approval of Sandozs ANDA until
September 2013 or until an adverse court decision, if any, whichever may occur earlier.
Propecia In December 2010, a patent infringement lawsuit was filed in the United States
against Hetero Drugs Limited (Hetero) in respect of Heteros application to the FDA seeking
pre-patent expiry approval to sell a generic version of Propecia. In March 2011, the Company
settled this lawsuit with Hetero by agreeing to allow Hetero to sell a generic 1 mg finasteride
product beginning on July 1, 2013.
Temodar In July 2007, a patent infringement action was filed (jointly with Cancer Research
Technologies, Limited (CRT)) in the United States against Barr Laboratories (Barr) (later
acquired by Teva) in respect of Barrs application to the FDA seeking pre-patent expiry approval to
sell a generic version of Temodar. In January 2010, the court issued a decision finding the CRT
patent unenforceable on grounds of prosecution laches and inequitable conduct. In November 2010,
the appeals court issued a decision reversing the trial courts finding. In December 2010, Barr
filed a petition seeking a rehearing en banc of the appeal, which petition was denied. In June
2011, Barr filed a petition for review by the United States Supreme
Court, which was denied. By virtue of an
agreement that Barr not launch a product during the appeal process, the Company has agreed that
Barr can launch a product in August 2013.
In September 2010, a patent infringement lawsuit was filed (jointly with CRT) in the United
States against Sun Pharmaceutical Industries Inc. (Sun) in respect of Suns application to the
FDA seeking pre-patent expiry approval to sell a generic version of Temodar. The lawsuit
automatically stays FDA approval of Suns ANDA until February 2013 or until an adverse court
decision, if any, whichever may occur earlier. The Company, CRT and Sun have entered into an
agreement to stay the lawsuit pending the outcome of the Supreme Court appeal process in the Barr
lawsuit. In November 2010, a patent infringement lawsuit was filed (jointly with CRT) in the
United States against Accord HealthCare Inc. (Accord) in respect of its application to the FDA
seeking pre-patent expiry approval to sell a generic version of Temodar. The lawsuit automatically
stays FDA approval of Accords application until April 13, 2013 or until an adverse court decision,
if any, whichever may occur earlier.
Vytorin In December 2009, a patent infringement lawsuit was filed in the United States
against Mylan Pharmaceuticals, Inc. (Mylan) in respect of Mylans application to the FDA seeking
pre-patent expiry approval to sell a generic version of Vytorin. The lawsuit automatically stays
FDA approval of Mylans application until May 2012 or until an adverse court decision, if any,
whichever may occur earlier. A trial against Mylan jointly in respect of Zetia and Vytorin is
scheduled to begin on December 5, 2011. In February 2010, a patent infringement lawsuit was filed
in the United States against Teva in respect of Tevas application to the FDA seeking pre-patent
expiry approval to sell a generic version of Vytorin. In July 2011, the patent infringement
lawsuit was dismissed and Teva agreed not to sell generic versions of Zetia or Vytorin until the
Companys exclusivity rights expire on April 25, 2017, except in certain circumstances. In August
2010, a patent infringement lawsuit was filed in the United States against Impax Laboratories Inc.
(Impax) in respect of Impaxs application to the FDA seeking pre-patent expiry approval to sell a
generic version of Vytorin. An agreement was reached with Impax to stay the lawsuit pending the
outcome of the lawsuit with Mylan. In October 2011, a patent infringement lawsuit was filed in the
United States against Actavis Inc. (Actavis) in respect to Actavis application to the FDA
seeking pre-patent expiry approval to sell a generic version of Vytorin. The lawsuit automatically
stays FDA approval of Actavis application until May 2012 or until an adverse court decision, if
any, whichever may occur earlier.
Zetia In March 2007, a patent infringement lawsuit was filed in the United States against
Glenmark Pharmaceuticals Inc., USA and its parent corporation (collectively, Glenmark) in respect
of Glenmarks application to the FDA seeking pre-patent expiry approval to sell a generic version
of Zetia. In May 2010, Glenmark agreed to a settlement by virtue of which Glenmark will be
permitted to launch its generic product in the United States on December 12, 2016, subject to
receiving final FDA approval. In June 2010, a patent infringement
- 27 -
Notes to Consolidated Financial Statements (unaudited) (continued)
lawsuit was filed in the United
States against Mylan in respect of Mylans application to the FDA seeking pre-patent expiry
approval to sell a generic version of Zetia. The lawsuit automatically stays FDA approval of
Mylans application until December 2012 or until an adverse court decision, if any, whichever may
occur earlier. A trial
against Mylan jointly in respect of Zetia and Vytorin is scheduled to begin on December 5,
2011. In September 2010, a patent infringement lawsuit was filed in the United States against Teva
in respect of Tevas application to the FDA seeking pre-patent expiry approval to sell a generic
version of Zetia. In July 2011, the patent infringement lawsuit was dismissed without any rights
granted to Teva.
NuvaRing In February 2011, a patent infringement suit was brought against Merck in the
International Trade Commission by Femina Pharma Incorporated (Femina) in respect of the product
NuvaRing. The complaint alleges that NuvaRing infringes a patent owned by Femina. The lawsuit
seeks an exclusion order against the importation of NuvaRing into the United States. Trial in the
case is expected to be held in the first quarter of 2012.
Environmental Matters
As previously disclosed, approximately 2,200 plaintiffs have filed an amended complaint
against Old Merck and 12 other defendants in U.S. District Court, Eastern District of California
asserting claims under the Clean Water Act, the Resource Conservation and Recovery Act, as well as
negligence and nuisance. The suit seeks damages for personal injury, diminution of property value,
medical monitoring and other alleged real and personal property damage associated with groundwater,
surface water and soil contamination found at the site of a former Old Merck subsidiary in Merced,
California. Certain of the other defendants in this suit have settled with plaintiffs regarding
some or all aspects of plaintiffs claims. This lawsuit is proceeding in a phased manner. A jury
trial commenced in February 2011 during which a jury was asked to make certain factual findings
regarding whether contamination moved off-site to any areas where plaintiffs could have been
exposed to such contamination and, if so, when, where and in what amounts. Defendants in this
Phase 1 trial included Old Merck and three of the other original 12 defendants. In March
2011, the Phase 1 jury returned a mixed verdict, finding in favor of Old Merck and the other
defendants as to some, but not all, of plaintiffs claims. Specifically, the jury found that
contamination from the site did not enter or affect plaintiffs municipal water supply wells or any
private domestic wells. The jury found, however, that plaintiffs could have been exposed to
contamination via air emissions prior to 1994, as well as via surface water in the form of storm
drainage channeled into an adjacent irrigation canal, including during a flood in April 2006. In
response to post-trial motions by Old Merck and other defendants, on September 7, 2011 the court
entered an order setting aside a part of the Phase 1 jurys findings that had been in favor of
plaintiffs. Specifically, the court held that plaintiffs could not have been exposed to any
contamination in surface or flood water during the April 2006 flood or, in fact, at any time later
than 1991. Old Merck has moved for reconsideration of the remainder of the jurys Phase 1 verdict
that was adverse to Old Merck or, in the alternative, for an opportunity to take an immediate
appeal of the remainder of the Phase 1 verdict on the basis that the remainder of the Phase 1
verdict that was adverse to Old Merck was unsupported by the evidence and contrary to established
legal principles. In the event any portion of the Phase 1 jurys findings in favor of plaintiffs
is not set aside by the trial court or on appeal, it is anticipated that later phases of the
litigation would be required to address issues related to liability, causation and damages related
to specific plaintiffs.
As previously disclosed, the DOJ and the U.S. Environmental Protection Agency (the EPA)
notified the Company that they were pursuing civil penalties against Merck in excess of $2 million
for alleged violations of air, water and waste regulations resulting from the EPAs multi-media
inspections of Mercks West Point and Riverside, Pennsylvania facilities in 2006 and Mercks
subsequent information submissions to the EPA. A Stipulation settling this matter was filed in the
United States District Court for the Middle District of Pennsylvania on September 28, 2011 pursuant
to which the Company denied all alleged violations and agreed to a civil penalty in the amount of
$1.5 million.
Other Litigation
There are various other pending legal proceedings involving the Company, principally product
liability and intellectual property lawsuits. While it is not feasible to predict the outcome of
such proceedings, in the opinion of the Company, either the likelihood of loss is remote or any
reasonably possible loss associated with the resolution of such proceedings is not expected to be
material either individually or in the aggregate.
- 28 -
Notes to Consolidated Financial Statements (unaudited) (continued)
10. Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Non- |
|
|
|
|
|
|
Common Stock |
|
|
Paid-In |
|
|
Retained |
|
|
Comprehensive |
|
|
Treasury Stock |
|
|
Controlling |
|
|
|
|
($ and shares in millions) |
|
Shares |
|
|
Par Value |
|
|
Capital |
|
|
Earnings |
|
|
Loss |
|
|
Shares |
|
|
Cost |
|
|
Interests |
|
|
Total |
|
|
Balance January 1, 2010 |
|
|
3,563 |
|
|
$ |
1,781 |
|
|
$ |
39,683 |
|
|
$ |
41,405 |
|
|
$ |
(2,767 |
) |
|
|
454 |
|
|
$ |
(21,044 |
) |
|
$ |
2,427 |
|
|
$ |
61,485 |
|
Net income attributable to
Merck & Co., Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,393 |
|
Cash dividends declared on
common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,552 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,552 |
) |
Mandatory conversion of 6%
convertible preferred stock |
|
|
4 |
|
|
|
2 |
|
|
|
132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
134 |
|
Treasury stock shares purchased |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
47 |
|
|
|
(1,593 |
) |
|
|
|
|
|
|
(1,593 |
) |
Share-based compensation
plans and other |
|
|
10 |
|
|
|
5 |
|
|
|
742 |
|
|
|
|
|
|
|
|
|
|
|
(4 |
) |
|
|
129 |
|
|
|
|
|
|
|
876 |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(723 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(723 |
) |
Net income attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89 |
|
|
|
89 |
|
Distributions attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(61 |
) |
|
|
(61 |
) |
|
Balance September 30, 2010 |
|
|
3,577 |
|
|
$ |
1,788 |
|
|
$ |
40,557 |
|
|
$ |
39,246 |
|
|
$ |
(3,490 |
) |
|
|
497 |
|
|
$ |
(22,508 |
) |
|
$ |
2,455 |
|
|
$ |
58,048 |
|
|
Balance January 1, 2011 |
|
|
3,577 |
|
|
$ |
1,788 |
|
|
$ |
40,701 |
|
|
$ |
37,536 |
|
|
$ |
(3,216 |
) |
|
|
495 |
|
|
$ |
(22,433 |
) |
|
$ |
2,429 |
|
|
$ |
56,805 |
|
Net income attributable to
Merck & Co., Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,760 |
|
Cash dividends declared on
common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,533 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,533 |
) |
Treasury stock shares purchased |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41 |
|
|
|
(1,359 |
) |
|
|
|
|
|
|
(1,359 |
) |
Share-based compensation
plans and other |
|
|
|
|
|
|
|
|
|
|
16 |
|
|
|
|
|
|
|
|
|
|
|
(11 |
) |
|
|
377 |
|
|
|
|
|
|
|
393 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
503 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
503 |
|
Net income attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89 |
|
|
|
89 |
|
Distributions attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(62 |
) |
|
|
(62 |
) |
|
Balance September 30, 2011 |
|
|
3,577 |
|
|
$ |
1,788 |
|
|
$ |
40,717 |
|
|
$ |
38,763 |
|
|
$ |
(2,713 |
) |
|
|
525 |
|
|
$ |
(23,415 |
) |
|
$ |
2,456 |
|
|
$ |
57,596 |
|
|
In connection with the 1998 restructuring of Astra Merck Inc., the Company assumed $2.4
billion par value preferred stock with a dividend rate of 5% per annum, which is carried by KBI and
included in Noncontrolling interests on the Consolidated Balance Sheet. If AstraZeneca exercises
the Shares Option (see Note 8), this preferred stock obligation will be settled.
- 29 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The accumulated balances related to each component of other comprehensive income (loss), net
of taxes, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
|
Cumulative |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
Benefit |
|
|
Translation |
|
|
Comprehensive |
|
($ in millions) |
|
Derivatives |
|
|
Investments |
|
|
Plans |
|
|
Adjustment |
|
|
Income (Loss) |
|
|
Balance January 1, 2010 |
|
$ |
(42 |
) |
|
$ |
33 |
|
|
$ |
(2,469 |
) |
|
$ |
(289 |
) |
|
$ |
(2,767 |
) |
Other comprehensive income (loss) |
|
|
30 |
|
|
|
17 |
|
|
|
142 |
|
|
|
(912 |
) |
|
|
(723 |
) |
|
Balance at September 30, 2010 |
|
$ |
(12 |
) |
|
$ |
50 |
|
|
$ |
(2,327 |
) |
|
$ |
(1,201 |
) |
|
$ |
(3,490 |
) |
|
Balance January 1, 2011 |
|
$ |
41 |
|
|
$ |
31 |
|
|
$ |
(2,043 |
) |
|
$ |
(1,245 |
) |
|
$ |
(3,216 |
) |
Other comprehensive income (loss) |
|
|
(77 |
) |
|
|
(11 |
) |
|
|
59 |
|
|
|
532 |
|
|
|
503 |
|
|
Balance at September 30, 2011 |
|
$ |
(36 |
) |
|
$ |
20 |
|
|
$ |
(1,984 |
) |
|
$ |
(713 |
) |
|
$ |
(2,713 |
) |
|
Comprehensive income (loss) was $1.8 billion and $1.5 billion for the three months ended
September 30, 2011 and 2010, respectively, and was $5.3 billion and $669 million for the nine
months ended September 30, 2011 and 2010, respectively.
Included in the cumulative translation adjustment are pretax (losses) gains of $(84) million
and $221 million for the first nine months of 2011 and 2010, respectively, from euro-denominated
notes which have been designated as, and are effective as, economic hedges of the net investment in
a foreign operation. Also included in cumulative translation adjustment are pretax gains (losses)
of approximately $393 million and $(963) million for the first nine months of 2011 and 2010,
respectively, relating to translation impacts of intangible assets recorded in conjunction with the
Merger.
11. Share-Based Compensation Plans
The Company has share-based compensation plans under which employees and non-employee
directors may be granted restricted stock units (RSUs). In addition, the Company grants options
to purchase shares of Company common stock at the fair market value at the time of grant and
performance share units (PSUs) to certain management-level employees. The Company recognizes the
fair value of share-based compensation in net income on a straight-line basis over the requisite
service period.
The following table provides amounts of share-based compensation cost recorded in the
Consolidated Statement of Income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pretax share-based compensation expense |
|
$ |
86 |
|
|
$ |
125 |
|
|
$ |
287 |
|
|
$ |
400 |
|
Income tax benefit |
|
|
(30 |
) |
|
|
(42 |
) |
|
|
(99 |
) |
|
|
(136 |
) |
|
Total share-based compensation expense, net of taxes |
|
$ |
56 |
|
|
$ |
83 |
|
|
$ |
188 |
|
|
$ |
264 |
|
|
During the first nine months of 2011 and 2010, the Company granted 8 million RSUs with a
weighted-average grant date fair value of $36.44 per RSU and 10 million RSUs with a
weighted-average grant date fair value of $33.90 per RSU, respectively.
- 30 -
Notes to Consolidated Financial Statements (unaudited) (continued)
During the first nine months of 2011 and 2010, the Company granted 8 million options with a
weighted-average exercise price of $36.55 per option and 7 million options with a weighted-average
exercise price of $34.27 per option, respectively. The weighted-average fair value of options
granted for the first nine months of 2011 and 2010 was $5.37 and $7.99 per option, respectively,
and was determined using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2011 |
|
|
2010 |
|
|
Expected dividend yield |
|
|
4.3 |
% |
|
|
4.1 |
% |
Risk-free interest rate |
|
|
2.6 |
% |
|
|
2.8 |
% |
Expected volatility |
|
|
23.2 |
% |
|
|
33.7 |
% |
Expected life (years) |
|
|
7.0 |
|
|
|
6.8 |
|
|
At September 30, 2011, there was $483 million of total pretax unrecognized compensation
expense related to nonvested stock options, RSU and PSU awards which will be recognized over a
weighted-average period of 1.9 years. For segment reporting, share-based compensation costs are
unallocated expenses.
12. Pension and Other Postretirement Benefit Plans
The Company has defined benefit pension plans covering eligible employees in the United States
and in certain of its international subsidiaries. The net cost of such plans consisted of the
following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Service cost |
|
$ |
158 |
|
|
$ |
125 |
|
|
$ |
461 |
|
|
$ |
426 |
|
Interest cost |
|
|
182 |
|
|
|
158 |
|
|
|
541 |
|
|
|
507 |
|
Expected return on plan assets |
|
|
(243 |
) |
|
|
(225 |
) |
|
|
(728 |
) |
|
|
(657 |
) |
Net amortization |
|
|
58 |
|
|
|
22 |
|
|
|
149 |
|
|
|
110 |
|
Termination benefits |
|
|
15 |
|
|
|
14 |
|
|
|
32 |
|
|
|
42 |
|
Curtailments |
|
|
(6 |
) |
|
|
(3 |
) |
|
|
(16 |
) |
|
|
(40 |
) |
Settlements |
|
|
|
|
|
|
|
|
|
|
(1 |
) |
|
|
(7 |
) |
|
|
|
$ |
164 |
|
|
$ |
91 |
|
|
$ |
438 |
|
|
$ |
381 |
|
|
The Company provides medical, dental and life insurance benefits, principally to its eligible
U.S. retirees and similar benefits to their dependents, through its other postretirement benefit
plans. The net cost of such plans consisted of the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Service cost |
|
$ |
27 |
|
|
$ |
27 |
|
|
$ |
83 |
|
|
$ |
81 |
|
Interest cost |
|
|
35 |
|
|
|
37 |
|
|
|
106 |
|
|
|
111 |
|
Expected return on plan assets |
|
|
(35 |
) |
|
|
(32 |
) |
|
|
(106 |
) |
|
|
(97 |
) |
Net amortization |
|
|
(4 |
) |
|
|
1 |
|
|
|
(13 |
) |
|
|
5 |
|
Termination benefits |
|
|
5 |
|
|
|
9 |
|
|
|
11 |
|
|
|
36 |
|
Curtailments |
|
|
(1 |
) |
|
|
1 |
|
|
|
|
|
|
|
(1 |
) |
|
|
|
$ |
27 |
|
|
$ |
43 |
|
|
$ |
81 |
|
|
$ |
135 |
|
|
In connection with restructuring actions (see Note 2), termination charges for the three and
nine months ended September 30, 2011 and 2010 were recorded on pension and other postretirement
benefit plans related to expanded eligibility for certain employees exiting Merck. Also, in
connection with these restructuring actions, curtailments were recorded on pension and other
postretirement benefit plans and settlements were recorded on pension plans as reflected in the
tables above.
- 31 -
Notes to Consolidated Financial Statements (unaudited) (continued)
13. Other (Income) Expense, Net
Other (income) expense, net, consisted of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Interest income |
|
$ |
(45 |
) |
|
$ |
(23 |
) |
|
$ |
(137 |
) |
|
$ |
(57 |
) |
Interest expense |
|
|
189 |
|
|
|
173 |
|
|
|
557 |
|
|
|
539 |
|
Exchange losses |
|
|
59 |
|
|
|
8 |
|
|
|
102 |
|
|
|
84 |
|
Other, net |
|
|
(137 |
) |
|
|
950 |
|
|
|
287 |
|
|
|
429 |
|
|
|
|
$ |
66 |
|
|
$ |
1,108 |
|
|
$ |
809 |
|
|
$ |
995 |
|
|
Interest income in the third quarter and first nine months of 2011 increased primarily due to
higher average investment balances. Other, net (as presented in the table above) for the third
quarter and first nine months of 2011 includes a $136 million gain on the disposition of the
Companys interest in the JJMCP joint venture. In addition, Other, net for the first nine months
of 2011 reflects a $500 million charge related to the resolution of the arbitration proceeding
involving the Companys rights to market Remicade and Simponi (see Note 4), as well as a $127
million gain on the sale of certain manufacturing facilities and related assets. Other, net for
the third quarter and first nine months of 2010 reflects a $950 million charge for the Vioxx
Liability Reserve (see Note 9). In addition, Other, net for the first nine months of 2010 also
reflects $443 million of income recognized upon AstraZenecas asset option exercise and $102
million of income recognized on the settlement of certain disputed royalties.
Exchange losses for the first nine months of 2010 reflect a Venezuelan currency devaluation in
the first quarter of 2010 resulting in the recognition of $80 million of exchange losses.
Effective January 11, 2010, the Venezuelan government devalued its currency from at BsF 2.15 per
U.S. dollar to a two-tiered official exchange rate at (1) the essentials rate at BsF 2.60 per
U.S. dollar and (2) the non-essentials rate at BsF 4.30 per U.S. dollar. In January 2010, the
Company was required to remeasure its local currency operations in Venezuela to U.S. dollars as the
Venezuelan economy was determined to be hyperinflationary. Throughout 2010, the Company settled
its transactions at the essentials rate and therefore remeasured monetary assets and liabilities
using the essentials rate. In December 2010, the Venezuelan government announced it would
eliminate the essentials rate and, effective January 1, 2011, all transactions would be settled at
the official rate of at BsF 4.30 per U.S. dollar. As a result of this announcement, the Company
remeasured its December 31, 2010 monetary assets and liabilities at the new official rate.
Interest paid for the nine months ended September 30, 2011 and 2010 was $261 million and $442
million, respectively, which excludes commitment fees. Interest paid for the nine months ended
September 30, 2011 is net of $288 million received by the Company from the termination of certain
interest rate swap contracts during the period (see Note 5).
14. Taxes on Income
The effective tax rates of 26.7% for the third quarter of 2011 and 15.7% for the first nine
months of 2011 reflect the impacts of purchase accounting adjustments and restructuring costs,
partially offset by the beneficial impact of foreign earnings. In addition, the effective tax rate
for the first nine months of 2011 also reflects a net favorable impact relating to the settlement
of Old Mercks 2002-2005 federal income tax audit as discussed below, a $230 million net favorable
impact of certain foreign and state tax rate changes that resulted in a reduction of deferred tax
liabilities on intangibles established in purchase accounting, and
the favorable impact of the $500 million
charge related to the resolution of the arbitration proceeding with J&J. The effective tax rates
of 25.3% for the third quarter of 2010 and 37.1% for the first nine months of 2010, as compared
with the statutory rate of 35%, reflect a $380 million tax benefit from a change in a foreign
entitys tax rate, which resulted in a reduction in deferred tax liabilities on product intangibles
recorded in conjunction with the Merger, as well as the favorable impact of foreign earnings.
These favorable impacts were largely offset by the unfavorable impacts of purchase accounting
charges, restructuring charges and the third quarter charge for the Vioxx Liability Reserve for
which no tax impact was recorded. In addition, the effective tax rate for the first nine months of
2010 reflects the unfavorable impact of a $147 million charge associated with a change in tax law
that requires taxation of the prescription drug subsidy of the Companys retiree health benefit
plans which was enacted in the first quarter of 2010 as part of U.S. health care reform
legislation, as well as the unfavorable impact of AstraZenecas asset option exercise.
- 32 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The Company and Old Merck are both under examination by numerous tax authorities in various
jurisdictions globally.
The Company anticipates that its liability for unrecognized tax benefits at December 31, 2010
will be reduced by approximately $1.3 billion during 2011, as a result of various audit closures,
including the Internal Revenue Service (IRS) settlement discussed below, other settlements or the
expiration of the statute of limitations. The ultimate finalization of the Companys examinations
with relevant taxing authorities can include formal administrative and legal proceedings, which
could have a significant impact on the timing of the reversal of unrecognized tax benefits. The
Company believes that its reserves for uncertain tax positions are adequate to cover existing risks or
exposures.
In April 2011, the IRS concluded its examination of Old Mercks 2002-2005 federal income tax
returns and as a result the Company was required to make net payments of approximately $465
million. The Companys unrecognized tax benefits for the years under examination exceeded the
adjustments related to this examination period and therefore the Company recorded a net $700
million tax provision benefit in the second quarter of 2011. This net benefit reflects the
decrease of unrecognized tax benefits for the years under examination partially offset by increases
to the unrecognized tax benefits for years subsequent to the examination period as a result of this
settlement. The Company disagrees with the IRS treatment of one issue raised during this
examination and is appealing the matter through the IRS administrative process.
As previously disclosed, the Canada Revenue Agency (CRA) has proposed adjustments for 1999
and 2000 relating to intercompany pricing matters and, in July 2011, the CRA issued assessments for
other miscellaneous audit issues for tax years 2001-2004. These adjustments would increase
Canadian tax due by approximately $330 million (U.S. dollars) plus approximately $370 million (U.S.
dollars) of interest through September 30, 2011. The Company disagrees with the positions taken by
the CRA and believes they are without merit. The Company continues to contest the assessments
through the CRA appeals process. The CRA is expected to prepare similar adjustments for later
years. Management believes that resolution of these matters will not have a material effect on the
Companys financial position or liquidity.
In October 2001, IRS auditors asserted that two interest rate swaps that Schering-Plough
entered into with an unrelated party should be re-characterized as loans from affiliated companies,
resulting in additional tax liability for the 1991 and 1992 tax years. In September 2004,
Schering-Plough made payments to the IRS in the amount of $194 million for income taxes and $279
million for interest. The Companys tax reserves were adequate to cover these payments.
Schering-Plough filed refund claims for the taxes and interest with the IRS in December 2004.
Following the IRSs denial of Schering-Ploughs claims for a refund, Schering-Plough filed suit in
May 2005 in the U.S. District Court for the District of New Jersey for refund of the full amount of
taxes and interest. A decision in favor of the government was announced in August 2009. The
Companys appeal of the decision was denied by the U.S. Court of Appeals for the Third Circuit in
June 2011. The Companys petition for a rehearing was
denied.
In 2010, the IRS finalized its examination of Schering-Ploughs 2003-2006 tax years. In this
audit cycle, the Company reached an agreement with the IRS on an adjustment to income related to
intercompany pricing matters. This income adjustment mostly reduced net operating losses (NOLs)
and other tax credit carryforwards. Additionally, the Company is seeking resolution of one issue
raised during this examination through the IRS administrative appeals process. The Companys
reserves for uncertain tax positions were adequate to cover all adjustments related to this
examination period. The IRS began its examination of the 2007-2009 tax years for the Company in
2010.
- 33 -
Notes to Consolidated Financial Statements (unaudited) (continued)
15. Earnings Per Share
The Company calculates earnings per share pursuant to the two-class method, which is an
earnings allocation formula that determines earnings per share for common stock and participating
securities according to dividends declared and participation rights in undistributed earnings.
Under this method, all earnings (distributed and undistributed) are allocated to common shares and
participating securities based on their respective rights to receive dividends. RSUs and certain
PSUs granted before December 31, 2009 to certain management level employees participate in
dividends on the same basis as common shares and such dividends are nonforfeitable by the holder.
As a result, these RSUs and PSUs meet the definition of a participating security. For RSUs and
PSUs issued on or after January 1, 2010, dividends declared during the vesting period are payable
to the employees only upon vesting and therefore such RSUs and PSUs do not meet the definition of a
participating security.
The calculations of earnings per share under the two-class method are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Basic Earnings per Common Share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income attributable to Merck & Co., Inc. |
|
$ |
1,692 |
|
|
$ |
342 |
|
|
$ |
4,760 |
|
|
$ |
1,393 |
|
Less: Income allocated to participating securities |
|
|
3 |
|
|
|
2 |
|
|
|
12 |
|
|
|
6 |
|
|
Net income allocated to common shareholders |
|
$ |
1,689 |
|
|
$ |
340 |
|
|
$ |
4,748 |
|
|
$ |
1,387 |
|
|
Average common shares outstanding |
|
|
3,070 |
|
|
|
3,078 |
|
|
|
3,079 |
|
|
|
3,099 |
|
|
|
|
$ |
0.55 |
|
|
$ |
0.11 |
|
|
$ |
1.54 |
|
|
$ |
0.45 |
|
|
Earnings per Common Share Assuming Dilution |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income attributable to Merck & Co., Inc. |
|
$ |
1,692 |
|
|
$ |
342 |
|
|
$ |
4,760 |
|
|
$ |
1,393 |
|
Less: Income allocated to participating securities |
|
|
3 |
|
|
|
2 |
|
|
|
12 |
|
|
|
6 |
|
|
Net income allocated to common shareholders |
|
$ |
1,689 |
|
|
$ |
340 |
|
|
$ |
4,748 |
|
|
$ |
1,387 |
|
|
Average common shares outstanding |
|
|
3,070 |
|
|
|
3,078 |
|
|
|
3,079 |
|
|
|
3,099 |
|
Common shares issuable (1) |
|
|
21 |
|
|
|
24 |
|
|
|
23 |
|
|
|
24 |
|
|
Average common shares outstanding assuming dilution |
|
|
3,091 |
|
|
|
3,102 |
|
|
|
3,102 |
|
|
|
3,123 |
|
|
|
|
$ |
0.55 |
|
|
$ |
0.11 |
|
|
$ |
1.53 |
|
|
$ |
0.44 |
|
|
|
|
|
(1) |
|
Issuable primarily under share-based compensation plans. |
For the three months ended September 30, 2011 and 2010, 170 million and 173 million,
respectively, and for the nine months ended 2011 and 2010, 170 million and 177 million,
respectively, of common shares issuable under share-based compensation plans were excluded from the
computation of earnings per common share assuming dilution because the effect would have been
antidilutive.
- 34 -
Notes to Consolidated Financial Statements (unaudited) (continued)
16. Segment Reporting
The Companys operations are principally managed on a products basis and are comprised of four
operating segments Pharmaceutical, Animal Health, Consumer Care and Alliances (which includes
revenue and equity income from the Companys relationship with AZLP). The Animal Health, Consumer
Care and Alliances segments are not material for separate reporting and are included in all other
in the table below. The Pharmaceutical segment includes human health pharmaceutical and vaccine
products marketed either directly by the Company or through joint ventures. Human health
pharmaceutical products consist of therapeutic and preventive agents, generally sold by
prescription, for the treatment of human disorders. The Company sells these human health
pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies
and managed health care providers such as health maintenance organizations, pharmacy benefit
managers and other institutions. Vaccine products consist of preventive pediatric, adolescent and
adult vaccines, primarily administered at physician offices. The Company sells these human health
vaccines primarily to physicians, wholesalers, physician distributors and government entities. A
large component of pediatric and adolescent vaccines is sold to the U.S. Centers for Disease
Control and Prevention Vaccines for Children program, which is funded by the U.S. government.
Additionally, the Company sells vaccines to the Federal government for placement into vaccine
stockpiles. The Company also has animal health operations that discover, develop, manufacture and
market animal health products, including vaccines, which the Company sells to veterinarians,
distributors and animal producers. Additionally, the Company has consumer care operations that
develop, manufacture and market over-the-counter, foot care and sun care products, which are sold
through wholesale and retail drug, food chain and mass merchandiser outlets. Segment composition
reflects certain managerial changes that have been implemented. Consumer Care product sales
outside the United States and Canada, previously included in the Pharmaceutical segment, are now
included in the Consumer Care segment. Segment disclosures for prior periods have been recast on a
comparable basis with 2011.
Revenues and profits for these segments are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Segment revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
10,354 |
|
|
$ |
9,523 |
|
|
$ |
30,534 |
|
|
$ |
28,826 |
|
All other segment revenues |
|
|
1,559 |
|
|
|
1,453 |
|
|
|
4,833 |
|
|
|
4,548 |
|
|
|
|
$ |
11,913 |
|
|
$ |
10,976 |
|
|
$ |
35,367 |
|
|
$ |
33,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment profits: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
6,355 |
|
|
$ |
5,851 |
|
|
$ |
19,014 |
|
|
$ |
17,578 |
|
All other segment profits |
|
|
709 |
|
|
|
598 |
|
|
|
2,080 |
|
|
|
1,945 |
|
|
|
|
$ |
7,064 |
|
|
$ |
6,449 |
|
|
$ |
21,094 |
|
|
$ |
19,523 |
|
|
Segment profits are comprised of segment revenues less certain elements of materials and
production costs and operating expenses, including components of equity income or loss from
affiliates and depreciation and amortization expenses. For internal management reporting presented
to the chief operating decision maker, Merck does not allocate production costs, other than
standard costs, research and development expenses or general and administrative expenses, nor the
cost of financing these activities. Separate divisions maintain responsibility for monitoring and
managing these costs, including depreciation related to fixed assets utilized by these divisions
and, therefore, they are not included in segment profits.
- 35 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Sales of the Companys products were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Zetia |
|
$ |
614 |
|
|
$ |
571 |
|
|
$ |
1,788 |
|
|
$ |
1,668 |
|
Vytorin |
|
|
469 |
|
|
|
485 |
|
|
|
1,407 |
|
|
|
1,452 |
|
Integrilin |
|
|
53 |
|
|
|
63 |
|
|
|
172 |
|
|
|
203 |
|
Diabetes and Obesity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Januvia |
|
|
846 |
|
|
|
600 |
|
|
|
2,364 |
|
|
|
1,710 |
|
Janumet |
|
|
350 |
|
|
|
247 |
|
|
|
977 |
|
|
|
666 |
|
Diversified Brands |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cozaar/Hyzaar |
|
|
404 |
|
|
|
423 |
|
|
|
1,236 |
|
|
|
1,690 |
|
Zocor |
|
|
110 |
|
|
|
114 |
|
|
|
345 |
|
|
|
347 |
|
Propecia |
|
|
112 |
|
|
|
109 |
|
|
|
330 |
|
|
|
322 |
|
Claritin Rx |
|
|
55 |
|
|
|
53 |
|
|
|
240 |
|
|
|
210 |
|
Remeron |
|
|
65 |
|
|
|
50 |
|
|
|
181 |
|
|
|
160 |
|
Vasotec/Vaseretic |
|
|
57 |
|
|
|
69 |
|
|
|
173 |
|
|
|
191 |
|
Proscar |
|
|
58 |
|
|
|
58 |
|
|
|
171 |
|
|
|
172 |
|
Infectious Disease |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Isentress |
|
|
343 |
|
|
|
278 |
|
|
|
972 |
|
|
|
777 |
|
PegIntron |
|
|
163 |
|
|
|
168 |
|
|
|
482 |
|
|
|
539 |
|
Cancidas |
|
|
150 |
|
|
|
135 |
|
|
|
476 |
|
|
|
437 |
|
Primaxin |
|
|
124 |
|
|
|
135 |
|
|
|
397 |
|
|
|
452 |
|
Invanz |
|
|
107 |
|
|
|
91 |
|
|
|
296 |
|
|
|
249 |
|
Avelox |
|
|
59 |
|
|
|
59 |
|
|
|
227 |
|
|
|
224 |
|
Noxafil |
|
|
61 |
|
|
|
52 |
|
|
|
171 |
|
|
|
150 |
|
Crixivan/Stocrin |
|
|
56 |
|
|
|
49 |
|
|
|
151 |
|
|
|
148 |
|
Rebetol |
|
|
38 |
|
|
|
55 |
|
|
|
138 |
|
|
|
166 |
|
Victrelis |
|
|
31 |
|
|
|
|
|
|
|
53 |
|
|
|
|
|
Neurosciences and Ophthalmology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maxalt |
|
|
156 |
|
|
|
133 |
|
|
|
460 |
|
|
|
401 |
|
Cosopt/Trusopt |
|
|
124 |
|
|
|
114 |
|
|
|
360 |
|
|
|
353 |
|
Oncology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Temodar |
|
|
223 |
|
|
|
254 |
|
|
|
704 |
|
|
|
799 |
|
Emend |
|
|
98 |
|
|
|
91 |
|
|
|
305 |
|
|
|
268 |
|
Intron A |
|
|
47 |
|
|
|
50 |
|
|
|
143 |
|
|
|
155 |
|
Respiratory and Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Singulair |
|
|
1,336 |
|
|
|
1,215 |
|
|
|
4,018 |
|
|
|
3,638 |
|
Remicade |
|
|
561 |
|
|
|
661 |
|
|
|
2,156 |
|
|
|
2,004 |
|
Nasonex |
|
|
266 |
|
|
|
259 |
|
|
|
962 |
|
|
|
917 |
|
Clarinex |
|
|
128 |
|
|
|
131 |
|
|
|
492 |
|
|
|
486 |
|
Arcoxia |
|
|
108 |
|
|
|
94 |
|
|
|
321 |
|
|
|
284 |
|
Simponi |
|
|
74 |
|
|
|
27 |
|
|
|
203 |
|
|
|
55 |
|
Asmanex |
|
|
42 |
|
|
|
48 |
|
|
|
149 |
|
|
|
155 |
|
Proventil |
|
|
38 |
|
|
|
43 |
|
|
|
117 |
|
|
|
155 |
|
Dulera |
|
|
22 |
|
|
|
2 |
|
|
|
59 |
|
|
|
2 |
|
Vaccines (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gardasil |
|
|
445 |
|
|
|
316 |
|
|
|
935 |
|
|
|
768 |
|
ProQuad/M-M-R II/Varivax |
|
|
391 |
|
|
|
434 |
|
|
|
927 |
|
|
|
1,093 |
|
RotaTeq |
|
|
184 |
|
|
|
119 |
|
|
|
457 |
|
|
|
350 |
|
Pneumovax |
|
|
133 |
|
|
|
110 |
|
|
|
276 |
|
|
|
220 |
|
Zostavax |
|
|
108 |
|
|
|
23 |
|
|
|
254 |
|
|
|
136 |
|
Womens Health and Endocrine |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fosamax |
|
|
215 |
|
|
|
220 |
|
|
|
644 |
|
|
|
692 |
|
NuvaRing |
|
|
159 |
|
|
|
134 |
|
|
|
455 |
|
|
|
414 |
|
Follistim AQ |
|
|
129 |
|
|
|
119 |
|
|
|
404 |
|
|
|
389 |
|
Implanon |
|
|
80 |
|
|
|
64 |
|
|
|
220 |
|
|
|
165 |
|
Cerazette |
|
|
74 |
|
|
|
56 |
|
|
|
199 |
|
|
|
160 |
|
Other pharmaceutical (2) |
|
|
888 |
|
|
|
942 |
|
|
|
2,567 |
|
|
|
2,834 |
|
|
Total Pharmaceutical segment sales |
|
|
10,354 |
|
|
|
9,523 |
|
|
|
30,534 |
|
|
|
28,826 |
|
|
Other segment sales (3) |
|
|
1,559 |
|
|
|
1,453 |
|
|
|
4,833 |
|
|
|
4,548 |
|
|
Total segment sales |
|
|
11,913 |
|
|
|
10,976 |
|
|
|
35,367 |
|
|
|
33,374 |
|
|
Other (4) |
|
|
109 |
|
|
|
149 |
|
|
|
386 |
|
|
|
519 |
|
|
|
|
$ |
12,022 |
|
|
$ |
11,125 |
|
|
$ |
35,753 |
|
|
$ |
33,893 |
|
|
|
|
|
(1) |
|
These amounts do not reflect sales of vaccines sold in most major European
markets through the Companys joint venture, Sanofi Pasteur MSD, the results of which are
reflected in Equity income from affiliates. These amounts do, however, reflect supply sales
to Sanofi Pasteur MSD. |
|
(2) |
|
Other pharmaceutical primarily includes sales of other human pharmaceutical
products, including products within the franchises not listed separately. |
|
(3) |
|
Reflects other non-reportable segments, including Animal Health and Consumer Care,
and revenue from the Companys relationship with AZLP primarily relating to sales of Nexium,
as well as Prilosec. Revenue from AZLP was $299 million and $345 million for the third
quarter of 2011 and 2010, respectively, and $928 million and $950 million for the first nine
months of 2011 and 2010, respectively. |
|
(4) |
|
Other revenues are primarily comprised of miscellaneous corporate revenues,
third-party manufacturing sales, sales related to divested products or businesses and other
supply sales not included in segment results. |
- 36 -
Notes to Consolidated Financial Statements (unaudited) (continued)
A reconciliation of segment profits to Income before taxes is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Segment profits |
|
$ |
7,064 |
|
|
$ |
6,449 |
|
|
$ |
21,094 |
|
|
$ |
19,523 |
|
Other profits |
|
|
31 |
|
|
|
53 |
|
|
|
67 |
|
|
|
168 |
|
Adjustments |
|
|
242 |
|
|
|
73 |
|
|
|
718 |
|
|
|
323 |
|
Unallocated: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
45 |
|
|
|
23 |
|
|
|
137 |
|
|
|
57 |
|
Interest expense |
|
|
(189 |
) |
|
|
(173 |
) |
|
|
(557 |
) |
|
|
(539 |
) |
Equity income from affiliates |
|
|
47 |
|
|
|
98 |
|
|
|
62 |
|
|
|
98 |
|
Depreciation and amortization |
|
|
(619 |
) |
|
|
(699 |
) |
|
|
(1,814 |
) |
|
|
(1,985 |
) |
Research and development |
|
|
(1,954 |
) |
|
|
(2,322 |
) |
|
|
(6,048 |
) |
|
|
(6,552 |
) |
Amortization of purchase accounting adjustments |
|
|
(1,306 |
) |
|
|
(1,540 |
) |
|
|
(4,249 |
) |
|
|
(5,576 |
) |
Restructuring costs |
|
|
(119 |
) |
|
|
(50 |
) |
|
|
(773 |
) |
|
|
(864 |
) |
Arbitration settlement charge |
|
|
|
|
|
|
|
|
|
|
(500 |
) |
|
|
|
|
Legal reserve |
|
|
|
|
|
|
(950 |
) |
|
|
|
|
|
|
(950 |
) |
Gain on AstraZeneca option exercise |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
443 |
|
Other expenses, net |
|
|
(890 |
) |
|
|
(464 |
) |
|
|
(2,384 |
) |
|
|
(1,792 |
) |
|
|
|
$ |
2,352 |
|
|
$ |
498 |
|
|
$ |
5,753 |
|
|
$ |
2,354 |
|
|
Other profits are primarily comprised of miscellaneous corporate profits, as well as operating
profits related to third-party manufacturing sales, divested products or businesses and other
supply sales. Adjustments represent the elimination of the effect of double counting certain items
of income and expense. Equity income from affiliates includes taxes paid at the joint venture
level and a portion of equity income that is not reported in segment profits. Other expenses, net
include expenses from corporate and manufacturing cost centers and other miscellaneous income
(expense), net.
- 37 -
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Merger
On November 3, 2009, Merck & Co., Inc. (Old Merck) and Schering-Plough Corporation
(Schering-Plough) merged (the Merger). In the Merger, Schering-Plough acquired all of the
shares of Old Merck, which became a wholly owned subsidiary of Schering-Plough and was renamed
Merck Sharp & Dohme Corp. Schering-Plough continued as the surviving public company and was
renamed Merck & Co., Inc. (New Merck or the Company). However, for accounting purposes only,
the Merger was treated as an acquisition with Old Merck considered the accounting acquirer.
References in this report and in the accompanying financial statements to Merck for periods prior
to the Merger refer to Old Merck and for periods after the completion of the Merger to New Merck.
Arbitration Settlement
In April 2011,
Merck and Johnson & Johnson (J&J) reached agreement to amend the distribution
rights to Remicade (infliximab) and Simponi (golimumab). This agreement concluded the arbitration proceeding J&J initiated
in May 2009, requesting a ruling related to the distribution agreement following the announcement
of the proposed merger between Merck and Schering-Plough. Under the terms of the amended
distribution agreement, Merck relinquished exclusive marketing rights for Remicade and
Simponi to J&J in territories including Canada, Central and South America, the Middle
East, Africa and Asia Pacific effective July 1, 2011. Merck retained exclusive marketing rights
throughout Europe, Russia and Turkey (Retained Territories). The Retained Territories
represented approximately 70% of Mercks 2010 revenue of $2.8 billion from Remicade and Simponi.
In addition, beginning July 1, 2011, all profits derived from Mercks exclusive distribution of the
two products in the Retained Territories are being equally divided between Merck and J&J. Under
the prior terms of the distribution agreement, the contribution income (profit) split, which was at
58% to Merck and 42% percent to J&J, would have declined for Merck and increased for J&J each year
until 2014, when it would have been equally divided. J&J also received a one-time payment from
Merck of $500 million in April 2011.
U.S. Health Care Reform Legislation
In 2010, the United States enacted major health care reform legislation. Various insurance
market reforms began last year and will continue through full implementation in 2014. The new law
is expected to expand access to health care to more than 32 million Americans by the end of the
decade that did not previously have regular access to health care.
With respect to the effect of the law on the pharmaceutical industry, beginning in 2010, the
law increased the mandated Medicaid rebate from 15.1% to 23.1%, expanded the rebate to Medicaid
managed care utilization, and increased the types of entities eligible for the federal 340B drug
discount program. The implementation of these provisions reduced revenues by approximately $44
million and $43 million in the third quarter of 2011 and 2010, respectively, and by $129 million
and $120 million for the first nine months of 2011 and 2010, respectively.
Effective in 2011, the law also requires pharmaceutical manufacturers to pay a 50% discount on
Medicare Part D utilization by beneficiaries when they are in the Medicare Part D coverage gap
(i.e., the so-called donut hole). Approximately $39 million and $109 million was recorded as a
reduction to revenue in the third quarter and first nine months of 2011, respectively, related to
the estimated impact of this provision of health care reform.
- 38 -
Also, beginning in 2011, pharmaceutical manufacturers are required to pay an annual health
care reform fee. The total annual industry fee, which will be $2.5 billion in 2011, will be
assessed on each company in proportion to its share of sales to certain government programs, such
as Medicare and Medicaid. The Companys portion of the annual fee is payable no later than
September 30 of the applicable calendar year and is not tax deductible. The liability related to
the annual fee for 2011 was initially estimated by the Company to be $167 million and was recorded
in full during the first quarter of 2011 with a corresponding offset to a deferred asset. This
estimate was refined and revised downward by $5 million in the third quarter of 2011 to $162
million. The deferred asset is being amortized to Marketing and administrative expenses during
2011 on a straight-line basis (net of any revisions), therefore $37 million and $122 million of
expense was recognized in the third quarter and first nine months of 2011, respectively. The
preliminary invoice for this fee was received and paid by the Company in the third quarter of 2011.
Acquisition
In May 2011, Merck completed the acquisition of Inspire Pharmaceuticals, Inc. (Inspire), a
specialty pharmaceutical company focused on developing and commercializing ophthalmic products.
Under the terms of the merger agreement, Merck acquired all outstanding shares of common stock of
Inspire at a price of $5.00 per share in cash for a total of approximately $420 million. The
transaction was accounted for as an acquisition of a business; accordingly, the assets acquired and
liabilities assumed were recorded at their respective fair values as of the acquisition date. The
determination of fair value requires management to make significant estimates and assumptions. In
connection with the acquisition, substantially all of the purchase price was allocated to Inspires
product and product right intangible assets and related deferred tax liabilities, a deferred tax
asset relating to Inspires net operating loss carryforwards, and goodwill. Certain estimated
values are not yet finalized and may be subject to change. The Company expects to finalize these
amounts as soon as possible, but no later than one year from the acquisition date. This
transaction closed on May 16, 2011, and accordingly, the results of operations of the acquired
business have been included in the Companys results of operations beginning after the acquisition
date. Pro forma financial information has not been included because Inspires historical financial
results are not significant when compared with the Companys financial results.
Management Changes
In August 2011, Merck announced the appointment of Richard R. DeLuca Jr. as executive vice
president and president, Merck Animal Health, effective September 15, 2011. In September 2011,
Merck announced the appointment of Cuong Viet Do as chief strategy officer, effective October 3,
2011. Both Mr. DeLuca and Mr. Do report to Kenneth C. Frazier, Mercks president and chief
executive officer, and serve on the Companys Executive Committee.
In October 2011, Merck announced that Richard T. Clark, chairman, will retire from the Company
and the Merck board of directors effective December 1, 2011. The board elected Kenneth C. Frazier,
Mercks president and chief executive officer, to serve as chairman following Mr. Clarks
retirement.
Other
In September 2011, Merck announced that it will launch Merck for Mothers, a long-term effort
with global health partners to create a world where no woman has to
die from preventable complications of
pregnancy and childbirth. The launch includes a 10-year, $500 million initiative that applies
Mercks scientific and business expertise to making proven solutions more widely available,
developing new technologies and improving public awareness, policy efforts and private sector
engagement for maternal mortality. Merck for Mothers will focus on the two leading causes of
maternal mortality (excessive and uncontrolled bleeding after childbirth, known as post-partum
hemorrhage, and life-threatening high blood pressure during pregnancy, known as preeclampsia) as
well as family planning, which is known to play an important role in reducing maternal mortality.
- 39 -
Operating Results
Segment composition reflects certain managerial changes that have been implemented. Consumer
Care product sales outside the United States and Canada, previously included in the Pharmaceutical
segment, are now included in the Consumer Care segment. Segment disclosures for prior periods have
been recast on a comparable basis with 2011.
Sales
Worldwide sales were $12.0 billion for the third quarter of 2011, an increase of 8% compared
with the third quarter of 2010. Foreign exchange favorably affected global sales performance by 5%
for the third quarter of 2011. The revenue increase largely reflects higher sales of Januvia
(sitagliptin) and Janumet (sitagliptin/metformin HCI), Gardasil
[human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant], Singulair
(montelukast sodium), Zostavax (zoster vaccine live), RotaTeq (rotavirus vaccine, live, oral,
pentavalent) and Isentress (raltegravir). Also contributing to revenue growth in the quarter were
higher sales of Simponi, Zetia (ezetimibe), as well as increased sales of the Companys animal
health products. These increases were partially offset by lower sales of Remicade due to the relinquishment
of marketing rights in certain territories as a result of the arbitration settlement discussed
above. Revenue was also negatively affected by lower sales of Caelyx for which the Company no
longer has marketing rights, lower sales of ProQuad (measles, mumps, rubella and varicella virus
vaccine live) and lower revenue from the Companys relationship with AstraZeneca LP (AZLP).
Worldwide sales were $35.8 billion for the first nine months of 2011, an increase of 5%
compared with the same period in 2010. Foreign exchange favorably affected global sales
performance by 3% for the first nine months of 2011. The revenue increase largely reflects higher
sales of Januvia and Janumet, Singulair, Isentress, Gardasil, Remicade, Simponi, Zetia, Zostavax
and RotaTeq, as well as increased sales of the Companys animal health products. These increases
were partially offset by lower sales of Cozaar (losartan potassium) and Hyzaar (losartan potassium-hydrochlorothiazide), which lost patent protection in the United States in April 2010 and in a
number of major European markets in March 2010, as well as lower
sales of Caelyx and Subutex/Suboxone for which the Company
no longer has marketing rights, and decreased sales of Varivax (varicella virus vaccine live).
While many of the Companys brands are experiencing positive growth trends in the European
Union (EU) during 2011, the environment in the EU continues to be challenging. Many countries
have announced austerity measures, which include the implementation of pricing actions to reduce
prices of generic and patented drugs. While the Company is taking steps to mitigate the impact in
the EU, the austerity measures have negatively affected the Companys revenue performance in 2011 and
the Company anticipates the austerity measures will continue to negatively affect revenue
performance into 2012.
- 40 -
Sales of the Companys products were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Zetia |
|
$ |
614 |
|
|
$ |
571 |
|
|
$ |
1,788 |
|
|
$ |
1,668 |
|
Vytorin |
|
|
469 |
|
|
|
485 |
|
|
|
1,407 |
|
|
|
1,452 |
|
Integrilin |
|
|
53 |
|
|
|
63 |
|
|
|
172 |
|
|
|
203 |
|
Diabetes and Obesity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Januvia |
|
|
846 |
|
|
|
600 |
|
|
|
2,364 |
|
|
|
1,710 |
|
Janumet |
|
|
350 |
|
|
|
247 |
|
|
|
977 |
|
|
|
666 |
|
Diversified Brands |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cozaar/Hyzaar |
|
|
404 |
|
|
|
423 |
|
|
|
1,236 |
|
|
|
1,690 |
|
Zocor |
|
|
110 |
|
|
|
114 |
|
|
|
345 |
|
|
|
347 |
|
Propecia |
|
|
112 |
|
|
|
109 |
|
|
|
330 |
|
|
|
322 |
|
Claritin Rx |
|
|
55 |
|
|
|
53 |
|
|
|
240 |
|
|
|
210 |
|
Remeron |
|
|
65 |
|
|
|
50 |
|
|
|
181 |
|
|
|
160 |
|
Vasotec/Vaseretic |
|
|
57 |
|
|
|
69 |
|
|
|
173 |
|
|
|
191 |
|
Proscar |
|
|
58 |
|
|
|
58 |
|
|
|
171 |
|
|
|
172 |
|
Infectious Disease |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Isentress |
|
|
343 |
|
|
|
278 |
|
|
|
972 |
|
|
|
777 |
|
PegIntron |
|
|
163 |
|
|
|
168 |
|
|
|
482 |
|
|
|
539 |
|
Cancidas |
|
|
150 |
|
|
|
135 |
|
|
|
476 |
|
|
|
437 |
|
Primaxin |
|
|
124 |
|
|
|
135 |
|
|
|
397 |
|
|
|
452 |
|
Invanz |
|
|
107 |
|
|
|
91 |
|
|
|
296 |
|
|
|
249 |
|
Avelox |
|
|
59 |
|
|
|
59 |
|
|
|
227 |
|
|
|
224 |
|
Noxafil |
|
|
61 |
|
|
|
52 |
|
|
|
171 |
|
|
|
150 |
|
Crixivan/Stocrin |
|
|
56 |
|
|
|
49 |
|
|
|
151 |
|
|
|
148 |
|
Rebetol |
|
|
38 |
|
|
|
55 |
|
|
|
138 |
|
|
|
166 |
|
Victrelis |
|
|
31 |
|
|
|
|
|
|
|
53 |
|
|
|
|
|
Neurosciences and Ophthalmology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maxalt |
|
|
156 |
|
|
|
133 |
|
|
|
460 |
|
|
|
401 |
|
Cosopt/Trusopt |
|
|
124 |
|
|
|
114 |
|
|
|
360 |
|
|
|
353 |
|
Oncology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Temodar |
|
|
223 |
|
|
|
254 |
|
|
|
704 |
|
|
|
799 |
|
Emend |
|
|
98 |
|
|
|
91 |
|
|
|
305 |
|
|
|
268 |
|
Intron A |
|
|
47 |
|
|
|
50 |
|
|
|
143 |
|
|
|
155 |
|
Respiratory and Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Singulair |
|
|
1,336 |
|
|
|
1,215 |
|
|
|
4,018 |
|
|
|
3,638 |
|
Remicade |
|
|
561 |
|
|
|
661 |
|
|
|
2,156 |
|
|
|
2,004 |
|
Nasonex |
|
|
266 |
|
|
|
259 |
|
|
|
962 |
|
|
|
917 |
|
Clarinex |
|
|
128 |
|
|
|
131 |
|
|
|
492 |
|
|
|
486 |
|
Arcoxia |
|
|
108 |
|
|
|
94 |
|
|
|
321 |
|
|
|
284 |
|
Simponi |
|
|
74 |
|
|
|
27 |
|
|
|
203 |
|
|
|
55 |
|
Asmanex |
|
|
42 |
|
|
|
48 |
|
|
|
149 |
|
|
|
155 |
|
Proventil |
|
|
38 |
|
|
|
43 |
|
|
|
117 |
|
|
|
155 |
|
Dulera |
|
|
22 |
|
|
|
2 |
|
|
|
59 |
|
|
|
2 |
|
Vaccines (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gardasil |
|
|
445 |
|
|
|
316 |
|
|
|
935 |
|
|
|
768 |
|
ProQuad/M-M-R II/Varivax |
|
|
391 |
|
|
|
434 |
|
|
|
927 |
|
|
|
1,093 |
|
RotaTeq |
|
|
184 |
|
|
|
119 |
|
|
|
457 |
|
|
|
350 |
|
Pneumovax |
|
|
133 |
|
|
|
110 |
|
|
|
276 |
|
|
|
220 |
|
Zostavax |
|
|
108 |
|
|
|
23 |
|
|
|
254 |
|
|
|
136 |
|
Womens Health and Endocrine |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fosamax |
|
|
215 |
|
|
|
220 |
|
|
|
644 |
|
|
|
692 |
|
NuvaRing |
|
|
159 |
|
|
|
134 |
|
|
|
455 |
|
|
|
414 |
|
Follistim AQ |
|
|
129 |
|
|
|
119 |
|
|
|
404 |
|
|
|
389 |
|
Implanon |
|
|
80 |
|
|
|
64 |
|
|
|
220 |
|
|
|
165 |
|
Cerazette |
|
|
74 |
|
|
|
56 |
|
|
|
199 |
|
|
|
160 |
|
Other pharmaceutical (2) |
|
|
888 |
|
|
|
942 |
|
|
|
2,567 |
|
|
|
2,834 |
|
|
Total Pharmaceutical segment sales |
|
|
10,354 |
|
|
|
9,523 |
|
|
|
30,534 |
|
|
|
28,826 |
|
|
Other segment sales (3) |
|
|
1,559 |
|
|
|
1,453 |
|
|
|
4,833 |
|
|
|
4,548 |
|
|
Total segment sales |
|
|
11,913 |
|
|
|
10,976 |
|
|
|
35,367 |
|
|
|
33,374 |
|
|
Other (4) |
|
|
109 |
|
|
|
149 |
|
|
|
386 |
|
|
|
519 |
|
|
|
|
$ |
12,022 |
|
|
$ |
11,125 |
|
|
$ |
35,753 |
|
|
$ |
33,893 |
|
|
|
|
|
(1) |
|
These amounts do not reflect sales of vaccines sold in most major European
markets through the Companys joint venture, Sanofi Pasteur MSD, the results of which are
reflected in Equity income from affiliates. These amounts do, however, reflect supply sales
to Sanofi Pasteur MSD. |
|
(2) |
|
Other pharmaceutical primarily includes sales of other human pharmaceutical
products, including products within the franchises not listed separately. |
|
(3) |
|
Reflects other non-reportable segments, including Animal Health and Consumer Care,
and revenue from the Companys relationship with AZLP primarily relating to sales of Nexium,
as well as Prilosec. Revenue from AZLP was $299 million and $345 million for the third
quarter of 2011 and 2010, respectively, and was $928 million and $950 million for the first
nine months of 2011 and 2010, respectively. |
|
(4) |
|
Other revenues are primarily comprised of miscellaneous corporate revenues,
third-party manufacturing sales, sales related to divested products or businesses and other
supply sales not included in segment results. |
- 41 -
The provision for discounts includes indirect customer discounts that occur when a
contracted customer purchases directly through an intermediary wholesale purchaser, known as
chargebacks, as well as indirectly in the form of rebates owed based upon definitive contractual
agreements or legal requirements with private sector and public sector (Medicaid and Medicare Part
D) benefit providers, after the final dispensing of the product by a pharmacy to a benefit plan
participant. These discounts, in the aggregate, reduced revenues by $1.5 billion and $1.2 billion
for the three months ended September 30, 2011 and 2010, respectively, and $4.0 billion and $3.5
billion for the nine months ended September 30, 2011 and 2010, respectively. Inventory levels at
key U.S. wholesalers for each of the Companys major pharmaceutical products are generally less
than one month.
Pharmaceutical Segment Revenues
Cardiovascular
Sales of Zetia (also marketed as Ezetrol outside the United States), a cholesterol-absorption
inhibitor, were $614 million in the third quarter of 2011, an increase of 8% compared with the
third quarter of 2010, and were $1.8 billion for the first nine months of 2011, an increase of 7%
compared with the same period in 2010. These increases reflect favorable pricing in the United
States, and higher sales in international markets due in part to the positive impact of foreign
exchange, partially offset by volume declines in the United States. Sales of Vytorin
(ezetimibe/simvastatin) (marketed outside the United States as Inegy), a combination product
containing the active ingredients of both Zetia and Zocor (simvastatin), were $469 million and $1.4
billion for the third quarter and first nine months of 2011, respectively, representing declines of
3% compared with the same periods in 2010. These results reflect volume declines in the United
States, partially offset by sales increases in international markets due in large part to the positive
impact of foreign exchange.
Supplemental New Drug Applications (sNDAs) for Vytorin and Zetia have been accepted for
standard review by the U.S. Food and Drug Administration (the FDA). The sNDAs seek indications for
Vytorin, and for Zetia when used in combination with simvastatin, for the prevention of major
cardiovascular events in patients with chronic kidney disease. On November 2, 2011, the FDAs Endocrinologic and Metabolic Drugs Advisory Committee unanimously
voted to recommend approval of the ezetimibe/simvastatin combination for use in patients with
pre-dialysis chronic kidney disease based on the results of the Study of Heart and Renal Protection
(SHARP) trial. The Committees vote was mixed (with the majority not in favor) regarding whether
there is sufficient evidence to support approval specifically for patients with end-stage renal
disease who are receiving dialysis. The Committees non-binding recommendation will be considered
by the FDA in its assessment of these investigational uses for Vytorin and Zetia. Currently, the
Companys sNDAs remain under review, with FDA action expected in the first quarter of 2012.
As previously disclosed, in early September 2011, Merck was advised that the IMPROVE-IT executive committee has decided to
schedule the studys second interim analysis in the first quarter of 2012, rather than as
previously anticipated in late 2011. As previously disclosed, the Data Safety Monitoring Board for
IMPROVE-IT plans to conduct an interim analysis for efficacy when approximately 75% of the
pre-specified (5,250) primary clinical endpoints have occurred. The study is fully enrolled and
approximately 70% of its pre-specified events had been reported as of
early September 2011.
In July 2011, Merck and Astellas US, LLC (Astellas) entered into an agreement under which
Merck acquired exclusive rights in Canada, Mexico and the United States to develop and
commercialize the investigational intravenous formulation of vernakalant (vernakalant i.v.) from
Astellas. Under the terms of the agreement, Merck paid Astellas a de minimis upfront fee. In
addition, Astellas will be eligible for milestone payments associated with (i) development, (ii)
regulatory approval as well as (iii) sales thresholds associated with vernakalant i.v. in Canada,
Mexico and the United States. Astellas had been granted an exclusive license to develop and
commercialize vernakalant i.v. in Canada, Mexico and the United States by Cardiome Pharma Corp
(Cardiome). Under an agreement with Cardiome in 2009, Merck acquired exclusive rights outside of
Canada, Mexico and the United States to vernakalant i.v., as well as exclusive worldwide rights to
oral formulations of vernakalant. In September 2010, Merck was granted marketing approval in the
EU, Iceland and Norway for vernakalant i.v. (marketed as Brinavess) for rapid conversion of recent
onset atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial
fibrillation of seven days or less and for post-cardiac surgery patients with atrial fibrillation
of three days or less.
Diabetes and Obesity
Global sales of Januvia, Mercks dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment
of type 2 diabetes, were $846 million in the third quarter of 2011 and $2.4 billion for the first
nine months of 2011, representing increases of 41% and 38%, respectively, compared with the same
periods of 2010, reflecting growth in the United States, as well as in international markets,
particularly in Japan and across Europe. DPP-4 inhibitors represent a class of prescription
medications that improve blood sugar control in patients with type 2 diabetes by enhancing a
natural body system called the incretin system, which helps to regulate glucose by affecting the
beta cells and alpha cells in the pancreas.
Worldwide sales of Janumet, Mercks oral antihyperglycemic agent that combines sitagliptin
(Januvia) with metformin in a single tablet to target all three key defects of type 2 diabetes,
were $350 million for the third
- 42 -
quarter of 2011, an increase of 42% compared with the third quarter
of 2010, and were $977 million for the first nine months of 2011, an increase of 47% compared with
the first nine months of 2010, reflecting growth both in the United States and internationally.
In October 2011,
the FDA approved Juvisync (sitagliptin and simvastatin), a new
treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active
component of Januvia, with the cholesterol-lowering medication Zocor. Juvisync is the first
treatment option for health care providers to help patients who need the blood sugar-lowering
benefits of a DPP-4 inhibitor and the cholesterol-lowering benefits of simvastatin, with the
convenience of a single tablet once daily.
In July 2011, the Company received a Complete Response letter from the FDA for Janumet XR
(MK-0431A XR), the Companys investigational extended-release formulation of Janumet, related to
the resolution of pre-approval inspection issues. Merck has responded to the questions raised by
the FDA and expects a response from the FDA in the first quarter of 2012.
Diversified Brands
Mercks diversified brands are human health pharmaceutical products that are approaching the
expiration of their marketing exclusivity or are no longer protected by patents in developed
markets, but continue to be a core part of the Companys offering in other markets around the
world.
Global sales of Cozaar and its companion agent Hyzaar (a combination of Cozaar and
hydrochlorothiazide) for the treatment of hypertension declined 4% in the third quarter of 2011 and
27% in the first nine months of 2011 compared with the same periods in 2010. The patents that
provided U.S. market exclusivity for Cozaar and Hyzaar expired in April 2010. In addition, Cozaar
and Hyzaar lost patent protection in a number of major European markets in March 2010.
Accordingly, the Company has experienced significant declines in Cozaar and Hyzaar sales and the
Company expects the declines to continue.
Other products contained in the Diversified Brands franchise include among others, Zocor, a
statin for modifying cholesterol; Propecia (finasteride), a product for the treatment of male
pattern hair loss; prescription Claritin (loratadine) for the treatment of seasonal outdoor
allergies and year-round indoor allergies; Remeron (mirtazapine), an antidepressant; Vasotec
(enalapril maleate) and Vaseretic (enalapril maleate-hydrochlorothiazide) for hypertension and/or
heart failure; and Proscar (finasteride), a urology product for the treatment of symptomatic benign
prostate enlargement. Remeron lost market exclusivity in the United States in January 2010 and has
also lost market exclusivity in most European markets.
Infectious Disease
Global sales of Isentress, an HIV integrase inhibitor for use in combination with other
antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and
treatment-experienced adults, were $343 million in the third quarter of 2011, an increase of 23%
compared with the third quarter of 2010, and were $972 million in the first nine months of 2011, an
increase of 25% compared with the first nine months of 2010, reflecting positive performance in the
United States and Europe due in part to the impact of foreign exchange. Isentress works by
inhibiting the insertion of HIV DNA into human DNA by the integrase enzyme. Inhibiting integrase
from performing this essential function helps to limit the ability of the virus to replicate and
infect new cells.
Worldwide sales of PegIntron (peginterferon alpha-2b) for treating chronic hepatitis C were
$163 million for the third quarter of 2011, a decline of 3% compared with the third quarter of
2010, and were $482 million for the first nine months of 2011, a decrease of 11% compared with the
same period in 2010. The Company believes these declines were attributable in part to patient
treatment being delayed by health care providers in anticipation of new therapeutic options
becoming available.
In May 2011, the FDA approved Victrelis (boceprevir), the Companys innovative new oral
medicine for the treatment of chronic hepatitis C. Victrelis is approved for the treatment of
chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in
adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who
are previously untreated or who have failed previous interferon and ribavirin therapy. Victrelis
is an antiviral agent designed to interfere with the ability of the hepatitis C virus to replicate
by inhibiting a key viral enzyme. In July 2011, the European Commission (EC) approved Victrelis.
The ECs decision grants a single marketing authorization that is valid in the 27 countries that
are members of the EU, as well as unified labeling applicable to Iceland, Liechtenstein and Norway.
Victrelis has been launched in the United States and in
13 international markets: Brazil, Canada and 11 markets in the EU, including
France, Germany, the United Kingdom and Spain. Sales of Victrelis were $31 million for the third
quarter of 2011 and were $53 million for the first nine months of 2011.
- 43 -
Sales of Primaxin (imipenem and cilastatin), an anti-bacterial product, were $124
million in the third quarter of 2011 and $397 million in the first nine months of 2011,
representing declines of 8% and 12% compared with the same periods of 2010, primarily reflecting
unfavorable pricing and lower volumes due to competitive pressures. Patents on Primaxin have
expired worldwide and multiple generics have been launched in Europe. Accordingly, the Company is
experiencing a decline in sales of Primaxin and the Company expects the decline to continue.
Other products contained in the Infectious Disease franchise include among others, Cancidas
(caspofungin acetate), an anti-fungal product; Invanz (ertapenem) for the treatment of
certain infections; Avelox (moxifloxacin hydrochloride), a fluoroquinolone antibiotic for the treatment of
certain respiratory and skin infections; Noxafil (posaconazole) for the prevention of invasive
fungal infections; Crixivan (indinavir sulfate) and Stocrin (efavirenz), antiretroviral therapies
for the treatment of HIV infection; and Rebetol (ribavirin, USP) for use in combination with
PegIntron for treating chronic hepatitis C. The compound patent that provides U.S. market
exclusivity for Crixivan expires in 2012.
Neurosciences and Ophthalmology
Global sales of Maxalt (rizatriptan benzoate), Mercks tablet for the acute treatment of
migraine, were $156 million for the third quarter of 2011, an increase of 17% compared with the
third quarter of 2010, and were $460 million for the first nine months of 2011, an increase of 15%
compared with the first nine months of 2010, reflecting a higher inventory level in the United
States. The compound patent for Maxalt, together with pediatric exclusivity, provides market exclusivity in the United States
until December 2012. In addition, the patent for Maxalt will expire in a number of major
European markets in 2013. The Company anticipates that sales in the United States and in these
European markets will decline significantly after these patent expiries.
Worldwide
sales of ophthalmic products Cosopt (dorzolamide hydrochloride-timolol maleate) and
Trusopt (dorzolamide hydrochloride) were $124 million in the third quarter of 2011, an increase of
9% compared with the third quarter of 2010, and were $360 million in the first nine months of 2011,
an increase of 2% compared with the same period in 2010, reflecting higher sales in Japan partially
offset by lower sales in Europe that were mitigated in part by the positive impact of
foreign exchange. The patent that provided U.S. market exclusivity for Cosopt and Trusopt expired
in October 2008. Trusopt has also lost market exclusivity in a number of major European markets.
The patent for Cosopt will expire in a number of major European markets in March 2013 and the
Company expects sales in those markets to decline significantly thereafter.
In April 2011,
the New Drug Application (NDA) for Mercks investigational preservative-free
formulation of Cosopt ophthalmic solution, containing a combination topical carbonic anhydrase
inhibitor and beta-andrenergic receptor blocking agent, was accepted for standard review by the
FDA.
Bridion (sugammadex), for the reversal of certain muscle relaxants during surgery, is
currently approved and has launched in many countries outside of the United States. Sales of
Bridion were $52 million and $141 million for the third quarter and first nine months of 2011,
respectively. Bridion is in Phase III development in the United States.
In August 2009, the FDA approved Saphris (asenapine) for the acute treatment of schizophrenia
in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder
with or without psychotic features in adults. In September 2010, two sNDAs for Saphris were
approved in the United States to expand the products indications to the treatment of schizophrenia
in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with
bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the
acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. In
September 2010, asenapine, to be sold under the brand name Sycrest, received marketing approval in
the EU for the treatment of moderate to severe manic episodes associated with bipolar I disorder in
adults; the marketing approval did not include an indication for schizophrenia. In October 2010,
Merck and H. Lundbeck A/S (Lundbeck) announced a worldwide commercialization agreement for
Sycrest sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck paid a fee
and will make product supply payments in exchange for exclusive commercial rights to Sycrest in all
markets outside the United States, China and Japan. Merck retained exclusive commercial rights to
asenapine in the United States, China and Japan. Concurrently, Merck is continuing to pursue
regulatory approval for asenapine in other parts of the world.
Merck continues to focus on building the brand awareness of Saphris in the United States and
has launched a black cherry flavor of the sublingual tablet to provide an additional taste option.
Merck continues to monitor and assess Saphris/Sycrest and the related intangible asset. If
increasing the brand awareness, the additional flavor
- 44 -
option, or Lundbecks launch of the product
in the EU is not successful, the Company may take a non-cash impairment charge with respect to
Saphris/Sycrest, and such charge could be material.
The Neurosciences and Ophthalmology franchise also included the products
Subutex/Suboxone for the treatment of opiate addiction. In 2010, Merck sold the rights to Subutex/Suboxone in nearly
all markets back to Reckitt Benckiser Group PLC (Reckitt). The rights to the products in most
major markets reverted to Reckitt on July 1, 2010 and the
remainder has since reverted to Reckitt during 2011 with the
exception of some very small markets. Sales of Subutex/Suboxone were $110 million for
the first nine months of 2010.
Oncology
Sales of Temodar (temozolomide) (marketed as Temodal outside the United States), a treatment
for certain types of brain tumors, were $223 million for the third quarter of 2011, a decline of
12% compared with the third quarter of 2010, and were $704 million for the first nine months of
2011, a decline of 12% compared with the first nine months of 2010, primarily reflecting generic
competition in Europe. Temodar lost patent exclusivity in the EU in 2009.
Global sales of Emend (aprepitant), a treatment for chemotherapy-induced nausea and vomiting,
were $98 million in the third quarter of 2011, an increase of 8% compared with the third quarter of
2010, and were $305 million in the first nine months of 2011, an increase of 14% compared with the
same period in 2010, reflecting growth in international markets.
Other products in the Oncology franchise include among others, Intron A (interferon alpha-2b,
recombinant) for treating melanoma. Marketing rights for Caelyx for the treatment of ovarian
cancer, metastatic breast cancer and Kaposis sarcoma transitioned to J&J as of December 31, 2010.
Sales of Caelyx were $70 million and $209 million in the third quarter and first nine months of
2010, respectively.
In March 2011, the FDA approved Sylatron (peginterferon alfa-2b), a once-weekly subcutaneous
injection indicated for the adjuvant treatment of melanoma with microscopic or gross nodal
involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
Respiratory and Immunology
Worldwide sales for Singulair, a once-a-day oral medicine indicated for the chronic treatment
of asthma and for the relief of symptoms of allergic rhinitis, were $1.3 billion for the third
quarter of 2011, an increase of 10% compared with the third quarter of 2010 reflecting favorable
pricing in the United States and the favorable effect of foreign exchange. Sales for the first
nine months of 2011 were $4.0 billion, an increase of 10% compared with the first nine months of
2010 reflecting favorable pricing in the United States, the favorable effect of foreign exchange
and volume growth in Japan, partially offset by volume declines in the United States. Singulair
continues to be the number one prescribed branded product in the U.S. respiratory market. The
patent that provides U.S. market exclusivity for Singulair expires in August 2012. The Company
expects that within the two years following patent expiration, it will lose substantially all U.S.
sales of Singulair, with most of those declines coming in the first full year following patent
expiration. In addition, the patent for Singulair will expire in a number of major European
markets in August 2012 and the Company expects sales of Singulair in those markets will decline
significantly thereafter (although the six month Pediatric Market Exclusivity may extend this date
in some markets to February 2013).
Sales of Remicade, a treatment for inflammatory diseases, were $561 million for the third
quarter of 2011, a decrease of 15% compared with the third quarter of 2010, and were $2.2 billion
for the first nine months of 2011, an increase of 8% compared with the same period in 2010.
Foreign exchange favorably affected sales performance by 11% and 7% in the third quarter and first
nine months of 2011, respectively. Prior to July 1, 2011, Remicade was marketed by the Company
outside of the United States (except in Japan and certain other Asian markets). As a result of the
agreement reached in April 2011 to amend the distribution rights to Remicade and Simponi (see Note
4 to the interim consolidated financial statements), effective July 1, 2011, Merck relinquished
marketing rights for these products in certain territories including Canada, Central and South
America, the Middle East, Africa and Asia Pacific. The sales performance in the third quarter and
first nine months of 2011 as compared with same periods in 2010 reflect these changes. In
Merck-retained territories, Remicade sales grew 25% in the third quarter and 17% for the first nine
months of 2011, which reflect 15% and 9% favorable impacts from foreign exchange, respectively.
Simponi, a once-monthly subcutaneous treatment for certain inflammatory diseases, was approved by
the EC in October 2009. In January 2011, Simponi was approved in the EU for use in combination
with methotrexate in adults with severe, active and progressive rheumatoid arthritis not previously
treated with methotrexate and for the reduction in the rate of progression of joint damage as
measured by X-ray in rheumatoid arthritis patients. Sales of Simponi were $74 million in the third
quarter of 2011 compared with $27 million in the third quarter of 2010 and
- 45 -
were $203 million for
the first nine months of 2011 compared with $55 million for the first nine months of 2010. The
revenue increases in both periods were primarily driven by sales growth in the European markets
where the Company retained the marketing rights for Simponi.
Global sales of Nasonex (mometasone furoate monohydrate), an inhaled nasal corticosteroid for
the treatment of nasal allergy symptoms, were $266 million for the third quarter of 2011, an
increase of 3% compared with the third quarter of 2010 driven by positive performance in emerging
markets and the beneficial impact of foreign exchange. Sales of Nasonex were $962 million for the
first nine months of 2011, an increase of 5% compared with the same period in 2010, driven largely
by volume growth in Japan and Latin America and the positive effect of foreign exchange, partially
offset by volume declines in the United States.
Global sales of Clarinex (desloratadine) (marketed as Aerius in many countries outside the
United States), a non-sedating antihistamine, were $128 million for the third quarter of 2011, a
decrease of 2% compared with the third quarter of 2010. Sales of Clarinex for the first nine
months of 2011 were $492 million, an increase of 1% compared with the first nine months of 2010.
Other products included in the Respiratory and Immunology franchise include among others,
Arcoxia (etoricoxib) for the treatment of arthritis and pain; Asmanex (mometasone furoate
inhalation powder), an inhaled corticosteroid for asthma; Proventil (albuterol sulfate) Inhalation
Aerosol for the relief of bronchospasm; and Dulera (mometasone furoate/formoterol fumarate
dihydrate) Inhalation Aerosol for the treatment of asthma. An sNDA for Dulera for the treatment of
chronic obstructive pulmonary disease (COPD) has been accepted for review by the FDA.
Vaccines
The following discussion of vaccines does not include sales of vaccines sold in most major
European markets through Sanofi Pasteur MSD (SPMSD), the Companys joint venture with Sanofi
Pasteur, the results of which are reflected in Equity income from affiliates (see Selected Joint
Venture and Affiliate Information below). Supply sales to SPMSD, however, are included.
Worldwide sales of Gardasil recorded by Merck grew 41% in the third quarter of 2011 to $445
million and increased 22% for the first nine months of 2011 to
$935 million driven by increased vaccination of both females
and males and wholesaler purchases in conjunction with the launch in Japan.
Sales growth in the year-to-date period was partially offset by lower government orders in Canada.
Gardasil, the worlds top-selling human papillomavirus (HPV) vaccine, is indicated for girls and
women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused
by HPV types 16 and 18, precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18,
and genital warts caused by HPV types 6 and 11. Gardasil is also approved in the United States for
use in boys and men ages 9 through 26 years of age for the prevention of genital warts caused by
HPV types 6 and 11. In December 2010, the FDA approved a new indication for Gardasil for the
prevention of anal cancer caused by HPV types 16 and 18 and for the prevention of anal
intraepithelial neoplasia grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by
HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.
In June 2011, Gardasil was approved in Japan for the prevention of cervical cancer (squamous
cell cancer and adenocarcinoma) and their precursor lesions (cervical intraepithelial neoplasm
grade 1/2/3 and cervical adenocarcinoma in situ), vulvar intraepithelial neoplasia grade 1/2/3,
vaginal intraepithelial neoplasia grade 1/2/3 and genital warts caused by HPV types 6, 11, 16 and
18 in females 9 years of age and older.
In October 2011, the U.S. Centers for Disease Control and Preventions (CDC) Advisory
Committee on Immunization Practices voted to recommend that boys 11 to 12 years old be vaccinated
routinely with Gardasil to help prevent anal cancer caused by HPV types 16 and 18, anal dysplasias
and precancerous lesions caused by HPV types 6, 11, 16 and 18, and genital warts caused by HPV
types 6 and 11. Additionally, the Committee recommended that Gardasil be administered to males 13
to 21 years of age who have not previously been vaccinated or have not completed the three-dose
series, and that the vaccination series can be started at age 9 years at the discretion of their
physicians.
Global sales of RotaTeq, a vaccine to help protect against rotavirus gastroenteritis in
infants and children, recorded by Merck were $184 million in the third quarter of 2011, an increase
of 55% compared with the third quarter of 2010. Sales for the first nine months of 2011 were $457
million, an increase of 31% compared with the same period in 2010, reflecting favorable public
sector inventory fluctuations.
- 46 -
In recent years, the Company has experienced difficulties in producing its varicella zoster
virus (VZV)-containing vaccines. These difficulties have resulted in supply constraints for
ProQuad, Varivax and Zostavax. The Company is manufacturing bulk varicella and is producing doses
of Varivax and Zostavax.
A limited quantity of ProQuad, a pediatric combination vaccine to help protect against
measles, mumps, rubella and varicella, one of the VZV-containing vaccines, became available in the
United States for ordering in the second quarter of 2010. Mercks sales of ProQuad were $49
million and $97 million in the third quarter and first nine months of 2010, respectively. This
supply has been exhausted and the Company does not anticipate availability of ProQuad for the
remainder of 2011. Sales of ProQuad were $37 million in the first quarter of 2011. The Company did not record any sales of ProQuad in the second or third quarter of 2011.
Mercks sales of Varivax, a vaccine to help prevent chickenpox (varicella), were $290 million
for the third quarter of 2011 compared with $289 million for the third quarter of 2010 and were
$640 million for the first nine months of 2011 compared with $740 million for the first nine months
of 2010. Sales in the first nine months of 2010 include $48 million of revenue as a result of
government purchases for the CDCs Strategic National
Stockpile. Mercks sales of M-M-R II (measles, mumps and rubella virus vaccine live), a
vaccine to help protect against measles, mumps and rubella, were $102 million for the third quarter
of 2011 compared with $96 million for the third quarter of 2010 and were $251 million for the first
nine months of 2011 compared with $256 million for the first nine months of 2010. Sales of Varivax
and M-M-R II in the second and third quarters of 2011 benefited from the unavailability of ProQuad
as noted above.
Mercks sales of Zostavax, a vaccine to help prevent shingles (herpes zoster), were $108
million for the third quarter of 2011 as compared with $23 million in the third quarter of 2010 and
were $254 million in the first nine months of 2011 compared with $136 million in the first nine
months of 2010. Supply availability has improved, however the Company anticipates that backorders
will continue until inventory levels are sufficient to meet market demand. Due to these supply
constraints, no broad international launches or immunization programs are currently planned for
2011 or 2012.
In March 2011, the FDA approved an expanded age indication for Zostavax for the prevention of
shingles to include adults ages 50 to 59. Zostavax is now indicated for the prevention of herpes
zoster in individuals 50 years of age and older.
The adult formulation of Recombivax HB [hepatitis B vaccine (recombinant)], a vaccine against
hepatitis B, is now available.
Womens Health and Endocrine
Worldwide sales for Fosamax (alendronate sodium) and Fosamax Plus D (alendronate
sodium/cholecalciferol) (marketed as Fosavance throughout the EU and as Fosamac in Japan) for the
treatment and, in the case of Fosamax, prevention of osteoporosis were $215 million for the third
quarter of 2011, representing a decline of 2% over the comparable period of 2010, and were $644
million for the first nine months of 2011, a decrease of 7% compared with the same period in 2010.
These medicines have lost market exclusivity in the United States and have also lost market
exclusivity in most major European markets. Accordingly, the Company is experiencing
sales declines within the Fosamax product franchise and the Company expects the declines to
continue.
Worldwide sales of NuvaRing (etonogestrel/ethinyl estradiol), a contraceptive product, were
$159 million for the third quarter of 2011, an increase of 18% compared with the third quarter of
2010, and were $455 million for the first nine months of 2011, an increase of 10% compared with the
first nine months of 2010. Global sales of Follistim AQ (follitropin beta injection) (marketed in
most countries outside the United States as Puregon), a
biological fertility treatment, were $129 million for
the third quarter of 2011, an increase of 8% compared with the third quarter of 2010, and were $404
million for the first nine months of 2011, an increase of 4% compared with the first nine months of
2010. The increases in both periods were largely driven by the beneficial impact of foreign
exchange, as well as by positive performance in emerging markets. Puregon lost market exclusivity
in the EU in August 2009.
Other products contained in the Womens Health and Endocrine franchise include among others,
Implanon (etonogestrel implant), a single-rod subdermal contraceptive implant; and Cerazette
(desogestrol), a progestin only oral contraceptive.
The Company is currently experiencing difficulty manufacturing certain womens health
products. The Company is working to resolve these issues.
- 47 -
In
August 2011, Zoely, an oral contraceptive (nomegestrol
acetate 2.5 mg/17β-estradiol 1.5
mg), was granted marketing authorization by the EC for the prevention of pregnancy in women. Zoely
is a combined oral contraceptive tablet containing a unique monophasic combination of 2 hormones:
nomegestrol acetate, a highly selective progesterone-derived
progestin, and 17β estradiol, an
estrogen that is similar to the one naturally present in a womans body. The marketing
authorization of Zoely applies to all 27 EU member states plus
Iceland, Liechtenstein and Norway. Teva Pharmaceutical Industries Ltd.
holds exclusive marketing rights for Zoely in France, Italy,
Belgium and Spain.
On November 4, 2011, Merck received a Complete Response letter from the FDA for NOMAC/E2
(MK-8175A), which is being marketed as Zoely in the EU. The Company plans to have further
discussions with the FDA with regard to the letter.
Other
Animal Health
Animal Health includes pharmaceutical and vaccine products for the prevention, treatment and
control of disease in all major farm and companion animal species. Animal Health sales are
affected by intense competition and the frequent introduction of generic products. Global sales of
Animal Health products totaled $826 million for the third quarter of 2011, an increase of 20%
compared with the third quarter of 2010, and were $2.4 billion for the first nine months of 2011,
an increase of 12% compared with the first nine months of 2010. Foreign exchange favorably
affected global sales performance by 6% and 5%, respectively, in the third quarter and first nine
months of 2011. The increased sales in both periods reflect positive performance in cattle, swine
and poultry products.
Consumer Care
Consumer Care products include over-the-counter, foot care and sun care products such as
Claritin non-drowsy antihistamines; MiraLAX, a treatment for occasional constipation; Dr. Scholls
foot care products; and Coppertone sun care products. Global sales of Consumer Care products were
$421 million for the third quarter of 2011, an increase of 3% compared with the third quarter of
2010, reflecting increases in MiraLAX and Zegerid OTC,
a treatment for frequent heartburn, partially offset by declines in Dr. Scholls.
Consumer Care sales were $1.5 billion for the first nine months of 2011, an increase of 3%
compared with the first nine months of 2010, reflecting strong performance of Coppertone, partially
offset by declines in Dr. Scholls. Foreign exchange favorably affected global sales performance
by 2% and 1%, respectively, in the third quarter and first nine
months of 2011. Consumer Care product sales are affected by competition and consumer
spending patterns.
Alliances
AstraZeneca has an option to buy Old Mercks interest in Nexium and Prilosec, exercisable in
2012, and the Company believes that it is likely that AstraZeneca will exercise that option (see
Selected Joint Venture and Affiliate Information below). If AstraZeneca does exercise the
option, the Company will no longer record equity income from AZLP and supply sales to AZLP will
decline substantially.
Costs, Expenses and Other
In February 2010, the Company commenced actions under a global restructuring program (the
Merger Restructuring Program) in conjunction with the integration of the legacy Merck and legacy
Schering-Plough businesses. This Merger Restructuring Program is intended to optimize the cost
structure of the combined company. Additional actions under the program continued during 2010. On
July 29, 2011, the Company announced the latest phase of the Merger Restructuring Program during
which the Company expects to reduce its workforce measured at the time of the Merger by an
additional 12% to 13% across the Company worldwide. A majority of the workforce reductions in this
phase of the Merger Restructuring Program relate to manufacturing (including Animal Health),
administrative and headquarters organizations. Previously announced workforce reductions of
approximately 17% in earlier phases of the program primarily reflect the elimination of positions in sales,
administrative and headquarters organizations, as well as from the sale or closure of certain
manufacturing and research and development sites and the consolidation of office facilities. In
addition, the Company has eliminated over 2,500 positions which were vacant at the time of the
Merger. The Company will continue to hire employees in strategic growth areas of the business as
necessary. The Company will continue to pursue productivity efficiencies and evaluate its
manufacturing supply chain capabilities on an ongoing basis which may result in future
restructuring actions.
The Company recorded total pretax restructuring costs of $255 million and $384 million in the
third quarter of 2011 and 2010, respectively, and $1.2 billion and $1.5 billion for the first nine
months of 2011 and 2010, respectively, related to this program. The restructuring actions under
the Merger Restructuring Program are expected to be substantially completed by the end of 2013,
with the exception of certain actions, principally manufacturing-related, which are expected to be
completed by 2015, with the total cumulative pretax costs estimated to be approximately $5.8
billion to $6.6 billion. The Company estimates that approximately two-thirds of the cumulative
pretax costs relate to cash outlays, primarily related to employee separation expense.
Approximately one-third of the cumulative pretax costs are non-cash, relating primarily to the
accelerated depreciation of facilities to be closed or divested. The Company expects the Merger
Restructuring Program to yield annual savings by the end of 2013 of approximately $3.5 billion to
$4.0 billion and annual savings upon completion of the program of
- 48 -
approximately $4.0 billion to
$4.6 billion. These cost savings, which are expected to come from all areas of the Companys
pharmaceutical business, are in addition to the previously announced ongoing cost reduction
initiatives at both legacy companies. Additional savings will come from non-restructuring-related
activities.
In October 2008, Old Merck announced a global restructuring program (the 2008 Restructuring
Program) to reduce its cost structure, increase efficiency, and enhance competitiveness. As part
of the 2008 Restructuring Program, the Company expects to eliminate approximately 7,200 positions
6,800 active employees and 400 vacancies across the Company worldwide. Pretax restructuring
costs of $20 million were recorded in the third quarter of 2011 and $25 million and $130 million
for the first nine months of 2011 and 2010, respectively, related to the 2008 Restructuring
Program. The 2008 Restructuring Program is expected to be completed by the end of 2011, with the
exception of certain manufacturing-related actions, with the total cumulative pretax costs
estimated to be up to $2.0 billion. The Company estimates that two-thirds of the cumulative pretax
costs relate to cash outlays, primarily from employee separation expense. Approximately one-third
of the cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of
facilities to be closed or divested. Merck expects the 2008 Restructuring Program to yield
cumulative pretax savings of $3.8 billion to $4.2 billion from 2008 to 2013.
The Company anticipates that total costs associated with restructuring activities in 2011 for
the Merger Restructuring Program and the 2008 Restructuring Program will be in the range of $1.3
billion to $1.5 billion.
The costs associated with all of these restructuring activities are primarily comprised of
accelerated depreciation recorded in Materials and production, Marketing and administrative and
Research and development and separation costs recorded in Restructuring costs (see Note 2 to the
interim consolidated financial statements).
Materials and production costs were $4.4 billion for the third quarter of 2011, an increase of
4% compared with the third quarter of 2010, and were $12.7 billion for the first nine months of
2011, a decline of 9% compared with the first nine months of 2010. Costs in the third quarter of
2011 and 2010 include $1.3 billion and $1.1 billion, respectively, and for the first nine months of
2011 and 2010 include $3.7 billion and $3.4 billion, respectively, of expenses for the amortization
of intangible assets recognized in connection with mergers and acquisitions. Additionally,
expenses for the third quarter and first nine months of 2010 include $266 million and $2.1 billion
of amortization of purchase accounting adjustments to Schering-Ploughs inventories recognized
as a result of the Merger. Costs in the first nine months of 2011 include an intangible asset
impairment charge of $118 million. The Company may recognize additional non-cash impairment
charges in the future related to product intangibles that were measured at fair value and
capitalized in connection with mergers and acquisitions and such charges could be material. Also included in
materials and production costs were costs associated with restructuring activities which amounted
to $99 million and $44 million in the third quarter of 2011 and 2010, respectively, and $280
million and $325 million in the first nine months of 2011 and 2010, respectively, including
accelerated depreciation and asset write-offs related to the planned sale or closure of
manufacturing facilities. Separation costs associated with manufacturing-related headcount
reductions have been incurred and are reflected in Restructuring costs as discussed below.
Gross margin was 63.8% in the third quarter of 2011 compared with 62.3% in the third quarter
of 2010 and was 64.5% for the first nine months of 2011 compared with 58.8% for the first nine
months of 2010. The amortization of intangible assets and purchase accounting adjustments to
inventories, as well as the restructuring and impairment charges
noted above and certain acquisition-related costs had an unfavorable effect on gross margin of 11.5
and 12.6 percentage points for the third quarter of 2011 and 2010, respectively, and 11.8 and 16.8
percentage points for the first nine months of 2011 and 2010, respectively. Excluding these
impacts, the gross margin improvements reflect changes in product mix and lower costs due to
manufacturing efficiencies.
Marketing and administrative expenses were $3.3 billion in the third quarter of 2011, an
increase of 5% compared with the third quarter of 2010, and were $10.0 billion for the first nine
months of 2011, an increase of 5% compared with the first nine months of 2010. The increases were
due in part to the unfavorable effect of foreign exchange and strategic investments made in
emerging markets. Expenses for the third quarter and first nine months of 2011 included restructuring costs of $31 million
and $77 million, respectively, primarily related to accelerated
depreciation for facilities to be closed or divested. Expenses for the third quarter and first
nine months of 2010 included $130 million of such costs. Separation costs associated with sales
force reductions have been incurred and are reflected in Restructuring costs as discussed below.
Marketing and administrative expenses included $57 million and $64 million of acquisition-related
costs in the third quarter of 2011 and 2010, respectively, and $192 million and $219 million for
the first nine months of 2011 and 2010, respectively, consisting largely of integration costs
related to the Merger, and for the first nine months of 2011 also consist of severance costs associated with the acquisition of Inspire which
are not part of
- 49 -
the Companys formal restructuring programs. Additionally, marketing and
administrative expenses in the third quarter and first nine months of 2011 include $37 million and
$122 million, respectively, of expenses for the estimated annual health care reform fee which the
Company was required to pay beginning in 2011 as part of U.S. health care reform legislation. The
Company is amortizing the estimated cost for 2011 on a straight-line basis, net of any revisions to
the estimate.
Research and development expenses were $2.0 billion for the third quarter of 2011, a decline
of 16% compared with the third quarter of 2010, and were $6.0 billion for the first nine months of
2011, a decrease of 8% compared with the first nine months of 2010. Research and development
expenses are comprised of the costs associated within Merck Research Labs (MRL), the Companys
research and development division that focuses on human health-related activities, certain costs
from operating segments, including Pharmaceutical, Animal Health and Consumer Care, as well as from
other divisions responsible for production, general and administrative and depreciation. Research
and development expenses also include in-process research and development impairment charges and
research and development related restructuring charges. Research and development expenses in 2011
were favorably affected by cost savings resulting from restructuring activities.
Expenses incurred by MRL were approximately $1.1 billion and $1.2 billion for the third
quarter of 2011 and 2010, respectively, and $3.4 billion and $3.6 billion for the first nine months
of 2011, respectively. Research costs incurred by other divisions were approximately $800 million
and $750 million for the third quarter of 2011 and 2010, respectively, and $2.3 billion and $2.5
billion for the first nine months of 2011 and 2010, respectively. In addition, during the third
quarter and first nine months of 2011, the Company recorded $22 million and $343
million, respectively, of in-process research and development (IPR&D) impairment charges
primarily for programs that had previously been deprioritized and were either deemed to have no
alternative use during the period or were out-licensed to a third party for consideration that was
less than the related assets carrying value. During the third quarter and first nine months of
2010, the Company recorded $189 million and $216 million, respectively, of IPR&D impairment charges
attributable to compounds identified during the Companys pipeline prioritization review that were
abandoned and determined to have either no alternative use or were returned to the respective
licensor, as well as from expected delays in the launch timing or changes in cash flow assumptions
for certain compounds. The Company may recognize additional non-cash impairment charges in the
future for the cancellation of other pipeline programs that were measured at
fair value and capitalized in connection with mergers and acquisitions and such charges could be material. Also,
research and development expenses in the third quarter of 2011 and 2010 reflect $28 million and
$163 million, respectively, and for the first nine months of 2011 and 2010 reflect $89 million and
$313 million, respectively, of accelerated depreciation and asset abandonment costs associated with
restructuring activities.
Restructuring costs, primarily representing separation and other related costs associated with
restructuring activities, were $119 million and $773 million for the third quarter and first nine
months of 2011, respectively, a substantial majority of which related to the Merger Restructuring Program.
Costs for the first nine months of 2011 reflect a reduction of separation reserves of approximately
$50 million resulting from the Companys decision in the first quarter to retain approximately 380
employees at its Oss, Netherlands research facility that had previously been expected to be
separated. Restructuring costs were $50 million and $864 million for the third quarter and first
nine months of 2010, respectively, of which $43 million and $810 million, respectively, related to
the Merger Restructuring Program, $7 million and $62 million, respectively, related to the 2008
Restructuring Program and the remaining activity related to the legacy Schering-Plough Productivity
Transformation Program. Separation costs were incurred associated with actual headcount
reductions, as well as estimated expenses under existing severance programs for headcount
reductions that were probable and could be reasonably estimated. Merck eliminated approximately
1,510 positions in the third quarter of 2011 of which 1,300 related to the Merger Restructuring
Program, 110 related to the 2008 Restructuring Program and 100 related to the legacy
Schering-Plough Productivity Transformation Program. During the first nine months of 2011, Merck
eliminated approximately 3,025 positions of which 2,635 related to the Merger Restructuring
Program, 290 related to the 2008 Restructuring Program and 100
related to the legacy Schering-Plough
program. For the third quarter of 2010, Merck eliminated 2,385 positions of which 2,175 related to
the Merger Restructuring Program, 180 related to the 2008 Restructuring Program and the remainder
to the legacy Schering-Plough Productivity Transformation Program. Merck eliminated 10,820
positions in the first nine months of 2010, of which 9,760 related to the Merger Restructuring
Program, 955 related to the 2008 Restructuring Program and the remainder to the legacy
Schering-Plough program. These position eliminations are comprised of actual headcount reductions,
and the elimination of contractors and vacant positions. Also included in restructuring costs are
curtailment, settlement and termination charges associated with pension and other postretirement
benefit plans, share-based compensation and shutdown costs. For segment reporting, restructuring
costs are unallocated expenses. Additional costs associated with the Companys
- 50 -
restructuring
activities are included in Materials and production, Marketing and administrative and Research and
development. (See Note 2 to the interim consolidated financial statements.)
Equity income from affiliates, which reflects the performance of the Companys joint ventures
and other equity method affiliates, primarily AZLP, was $161 million and $236 million in the third
quarter of 2011 and 2010, respectively, and was $354 million and $417 million in the first nine
months of 2011 and 2010, respectively. During the third quarter of 2011, the Company divested its
interest in the Johnson & Johnson° Merck Consumer
Pharmaceuticals Company (JJMCP) joint venture. (See Selected Joint Venture and Affiliate Information
below.)
Other (income) expense, net was $66 million of expense in the third quarter of 2011 compared
with $1.1 billion of expense in the third quarter of 2010. The third quarter of 2011 includes a
$136 million gain on the disposition of the Companys interest in the JJMCP joint venture (see Note
8 to the interim consolidated financial statements). The third quarter of 2010 reflects a $950
million charge for the Vioxx Liability Reserve (see Note 9 to the interim consolidated financial
statements). Other (income) expense, net was $809 million of expense in the first nine months of
2011 compared with $995 million of expense in the first nine months 2010. Included in other
(income) expense, net during the first nine months of 2011 was a $500 million charge related to the
resolution of the arbitration proceeding involving the Companys rights to market Remicade and
Simponi (see Note 4 to the interim consolidated financial statements), a gain of $136 million
related to the divestiture of the JJMCP joint venture noted above, and a $127 million gain on the sale of
certain manufacturing facilities and related assets. Included in other (income) expense, net in
the first nine months of 2010 was the $950 million legal charge for the Vioxx Liability Reserve
noted above, $443 million of income recognized upon AstraZenecas exercise of the asset option (see
Note 8 to the interim consolidated financial statements) and $102 million of income on the
settlement of certain disputed royalties. Additionally, during the first nine months of 2010, the
Company recognized exchange losses of $80 million related to a Venezuelan currency devaluation.
Effective January 11, 2010, the Venezuelan government devalued its
currency from at BsF 2.15 per U.S. dollar to a two-tiered official exchange rate at (1) the
essentials rate at BsF 2.60 per U.S. dollar and (2) the non-essentials rate at BsF 4.30 per U.S.
dollar. In January 2010, Merck was required to remeasure its local currency operations in
Venezuela to U.S. dollars as the Venezuelan economy was determined to be hyperinflationary.
Throughout 2010, the Company settled its transactions at the essentials rate and therefore
remeasured monetary assets and liabilities using the essentials rate. In December 2010, the
Venezuelan government announced it would eliminate the essentials rate and, effective January 1,
2011, all transactions would be settled at the official rate of at BsF 4.30 per U.S. dollar. As a
result of this announcement, the Company remeasured its December 31, 2010 monetary assets and
liabilities at the new official rate.
Segment Profits
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pharmaceutical segment profits |
|
$ |
6,355 |
|
|
$ |
5,851 |
|
|
$ |
19,014 |
|
|
$ |
17,578 |
|
Other non-reportable segment profits |
|
|
709 |
|
|
|
598 |
|
|
|
2,080 |
|
|
|
1,945 |
|
Other |
|
|
(4,712 |
) |
|
|
(5,951 |
) |
|
|
(15,341 |
) |
|
|
(17,169 |
) |
|
Income before income taxes |
|
$ |
2,352 |
|
|
$ |
498 |
|
|
$ |
5,753 |
|
|
$ |
2,354 |
|
|
Segment profits are comprised of segment revenues less certain elements of materials and
production costs and operating expenses, including components of equity income or loss from
affiliates and depreciation and amortization expenses. For internal management reporting presented
to the chief operating decision maker, Merck does not allocate production costs, other than
standard costs, research and development expenses or general and administrative expenses, nor the
cost of financing these activities. Separate divisions maintain responsibility for monitoring and
managing these costs, including depreciation related to fixed assets utilized by these divisions
and, therefore, they are not included in segment profits. Also excluded from the determination of
segment profits are the arbitration settlement charge and the gain on the divestiture of the JJMCP
joint venture recorded in 2011, the charge for the Vioxx Liability Reserve and the gain on
AstraZenecas asset option exercise both recognized in 2010, the amortization of purchase
accounting adjustments, intangible asset impairment charges, acquisition-related costs,
restructuring costs, taxes paid at the joint venture level and a portion of equity income.
Additionally, segment profits do not reflect other expenses from corporate and manufacturing cost
centers and other miscellaneous income or expense. These unallocated items are reflected in
Other in the above table. Also included in Other are miscellaneous corporate profits,
operating profits related to third-party manufacturing sales, divested products or businesses, as
well as other supply sales and adjustments to eliminate the effect of double counting certain items
of income and expense.
- 51 -
Pharmaceutical segment profits rose 9% and 8%, respectively, in the third quarter and first
nine months of 2011 driven largely by the increase in sales and the gross margin improvement
discussed above.
The effective tax rates of 26.7% for the third quarter of 2011 and 15.7% for the first nine
months of 2011 reflect the impacts of purchase accounting adjustments and restructuring costs,
partially offset by the beneficial impact of foreign earnings. In addition, the effective tax rate
for the first nine months of 2011 also reflects a net favorable impact of approximately $700
million relating to the settlement of Old Mercks 2002-2005 federal income tax audit, the favorable
impact of certain foreign and state tax rate changes that resulted in a net $230 million reduction
of deferred tax liabilities on intangibles established in purchase
accounting, and the favorable impact of
the $500 million charge related to the resolution of the arbitration proceeding with J&J. The
effective tax rates of 25.3% for the third quarter of 2010 and 37.1% for the first nine months of
2010, as compared with the statutory rate of 35%, reflect a $380 million tax benefit from a change
in a foreign entitys tax rate, which resulted in a reduction in deferred tax liabilities on
product intangibles recorded in conjunction with the Merger, as well as the favorable impact of
foreign earnings. These favorable impacts were largely offset by the unfavorable impacts of
purchase accounting charges, restructuring charges and the third quarter charge for the Vioxx
Liability Reserve for which no tax impact was recorded. In addition, the effective tax rate for
the first nine months of 2010 reflects the unfavorable impact of a $147 million charge associated
with a change in tax law that requires taxation of the prescription drug subsidy of the Companys
retiree health benefit plans which was enacted in the first quarter of 2010 as part of U.S. health
care reform legislation, as well as the unfavorable impact of AstraZenecas asset option exercise.
Net income attributable to Merck & Co., Inc. was $1.7 billion for the third quarter of 2011
compared with $342 million for the third quarter of 2010 and was $4.8 billion for the first nine
months of 2011 compared with $1.4 billion for the first nine months of 2010. Earnings per common
share assuming dilution attributable to Merck &
Co., Inc. common shareholders (EPS) for the third quarter of 2011 were $0.55 compared with
$0.11 in the third quarter of 2010 and were $1.53 in the first nine months of 2011 compared with
$0.44 in the first nine months of 2010. The increases in net income and EPS in the third quarter
and first nine months of 2011 were primarily due to lower amortization of inventory step-up, lower
legal reserves and restructuring costs and, for the year-to-date period, the favorable impact of
the tax settlement noted above. For the year-to-date period, the positive impact of these items on
net income and EPS was partially offset by the arbitration settlement charge recorded in 2011 and
the income recognized in 2010 on AstraZenecas asset option exercise.
Non-GAAP income and non-GAAP EPS are alternative views of the Companys performance used by
management that Merck is providing because management believes this information enhances investors
understanding of the Companys results. Non-GAAP income and non-GAAP EPS exclude certain items
because of the nature of these items and the impact that they have on the analysis of underlying
business performance and trends. The excluded items consist of acquisition-related costs,
restructuring costs and certain other items. These excluded items are significant components in
understanding and assessing financial performance. Therefore, the information on non-GAAP income
and non-GAAP EPS should be considered in addition to, but not in lieu of, net income and EPS
prepared in accordance with generally accepted accounting principles in the United States (GAAP).
Additionally, since non-GAAP income and non-GAAP EPS are not measures determined in accordance
with GAAP, they have no standardized meaning prescribed by GAAP and, therefore, may not be
comparable to the calculation of similar measures of other companies.
Non-GAAP income and non-GAAP EPS are important internal measures for the Company. Senior
management receives a monthly analysis of operating results that includes non-GAAP income and
non-GAAP EPS and the performance of the Company is measured on this basis along with other
performance metrics. Senior managements annual compensation is derived in part using non-GAAP
income and non-GAAP EPS.
- 52 -
A reconciliation between GAAP financial measures and non-GAAP financial measures is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
($ in millions, except per share amounts) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pretax income as reported under GAAP |
|
$ |
2,352 |
|
|
$ |
498 |
|
|
$ |
5,753 |
|
|
$ |
2,354 |
|
Increase (decrease) for excluded items: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related costs |
|
|
1,363 |
|
|
|
1,604 |
|
|
|
4,460 |
|
|
|
5,812 |
|
Costs related to restructuring programs |
|
|
277 |
|
|
|
387 |
|
|
|
1,219 |
|
|
|
1,632 |
|
Other items: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on disposition of interest in JJMCP joint venture and other |
|
|
(137 |
) |
|
|
|
|
|
|
(137 |
) |
|
|
|
|
Arbitration settlement charge |
|
|
|
|
|
|
|
|
|
|
500 |
|
|
|
|
|
Gain on sale of manufacturing facilities and related assets |
|
|
|
|
|
|
|
|
|
|
(127 |
) |
|
|
|
|
Vioxx Liability Reserve |
|
|
|
|
|
|
950 |
|
|
|
|
|
|
|
950 |
|
Gain on AstraZeneca asset option exercise |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(443 |
) |
|
|
|
|
3,855 |
|
|
|
3,439 |
|
|
|
11,668 |
|
|
|
10,305 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on income as reported under GAAP |
|
|
628 |
|
|
|
126 |
|
|
|
904 |
|
|
|
872 |
|
Estimated tax benefit on excluded items |
|
|
287 |
|
|
|
258 |
|
|
|
1,025 |
|
|
|
1,151 |
|
Tax benefit from settlement of federal income tax audit |
|
|
|
|
|
|
|
|
|
|
700 |
|
|
|
|
|
Tax benefit from foreign and state tax rate changes |
|
|
|
|
|
|
380 |
|
|
|
230 |
|
|
|
380 |
|
Tax charge related to U.S. health care reform legislation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(147 |
) |
|
|
|
|
915 |
|
|
|
764 |
|
|
|
2,859 |
|
|
|
2,256 |
|
|
Non-GAAP net income |
|
|
2,940 |
|
|
|
2,675 |
|
|
|
8,809 |
|
|
|
8,049 |
|
|
Less: Net income attributable to noncontrolling interests |
|
|
32 |
|
|
|
30 |
|
|
|
89 |
|
|
|
89 |
|
|
Non-GAAP net income attributable to Merck & Co., Inc. |
|
$ |
2,908 |
|
|
$ |
2,645 |
|
|
$ |
8,720 |
|
|
$ |
7,960 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPS assuming dilution as reported under GAAP |
|
$ |
0.55 |
|
|
$ |
0.11 |
|
|
$ |
1.53 |
|
|
$ |
0.44 |
|
EPS difference (1) |
|
|
0.39 |
|
|
|
0.74 |
|
|
|
1.27 |
|
|
|
2.10 |
|
|
Non-GAAP EPS assuming dilution |
|
$ |
0.94 |
|
|
$ |
0.85 |
|
|
$ |
2.80 |
|
|
$ |
2.54 |
|
|
|
|
|
(1) |
|
Represents the difference between calculated GAAP EPS and calculated non-GAAP
EPS, which may be different than the amount calculated by dividing the impact of the excluded
items by the weighted-average shares for the applicable
period. |
Acquisition-Related Costs
Non-GAAP income and non-GAAP EPS exclude the ongoing impact of certain amounts recorded in
connection with mergers and acquisitions. These amounts include the amortization of intangible
assets and inventory step-up, as well as intangible asset impairment charges. Amounts also include
integration costs associated with the Merger, as well as other costs associated with mergers and
acquisitions, such as severance costs which are not part of the Companys formal restructuring
programs. These costs are excluded because management believes that these costs are not
representative of ongoing normal business activities.
Restructuring Costs
Non-GAAP income and non-GAAP EPS exclude costs related to restructuring actions, including
restructuring activities related to the Merger (see Note 2 to the interim consolidated financial
statements). These amounts include employee separation costs and accelerated depreciation
associated with facilities to be closed or divested. Accelerated depreciation costs represent the
difference between the depreciation expense to be recognized over the revised useful life of the
site, based upon the anticipated date the site will be closed or divested, and depreciation expense
as determined utilizing the useful life prior to the restructuring actions. The Company has
undertaken restructurings of different types during the covered periods and therefore these charges
should not be considered non-recurring; however, management excludes these amounts from non-GAAP
income and non-GAAP EPS because it believes it is helpful for understanding the performance of the
continuing business.
- 53 -
Certain Other Items
Non-GAAP income and non-GAAP EPS exclude certain other items. These items represent
substantive, unusual items that are evaluated on an individual basis. Such evaluation considers
both the quantitative and the qualitative aspect of their unusual nature and generally represent
items that, either as a result of their nature or magnitude, management would not anticipate that
they would occur as part of the Companys normal business on a regular basis. Certain other items
are comprised of the gain on the divestiture of the Companys interest in the JJMCP joint venture
(see Note 8 to the interim consolidated financial statements), the charge related to the
arbitration settlement (see Note 4 to the interim consolidated financial statements) and the gain
associated with the sale of certain manufacturing facilities and related assets recorded in 2011,
as well as the gain recognized upon AstraZenecas asset option exercise in 2010 (see Note 8 to the
interim consolidated financial statements). Also excluded from non-GAAP income and non-GAAP EPS
are the tax benefits from the settlement of a federal income tax audit, the favorable impact of
certain foreign and state tax rate changes that resulted in a net reduction of deferred tax
liabilities on intangibles established in purchase accounting, and the tax charge related to U.S.
health care reform legislation (see Note 14 to the interim consolidated financial statements).
Research and Development Update
In October 2011, the FDA approved Juvisync (sitagliptin and simvastatin), a new treatment for
type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of
Januvia, with the cholesterol-lowering medication Zocor. Juvisync is the first treatment option
for health care providers to help patients who need the blood sugar-lowering benefits of a DPP-4
inhibitor and the cholesterol-lowering benefits of simvastatin, with the convenience of a single
tablet once daily.
In
August 2011, Zoely, a new oral contraceptive (nomegestrol
acetate 2.5 mg/17β-estradiol 1.5
mg), was granted marketing authorization by the EC for the prevention of pregnancy in women. Zoely
is a combined oral contraceptive tablet containing a unique monophasic combination of 2 hormones:
nomegestrol acetate, a highly selective progesterone-derived
progestin, and 17β estradiol, an
estrogen that is similar to the one naturally present in a womans body. The marketing
authorization of Zoely applies to all 27 EU member states plus
Iceland, Liechtenstein and Norway. Teva Pharmaceutical Industries
Ltd. holds exclusive marketing rights for Zoely in France,
Italy, Belgium and Spain.
On November 4, 2011, Merck received a Complete Response letter from the FDA for NOMAC/E2
(MK-8175A), which is being marketed as Zoely in the EU. The Company plans to have further
discussions with the FDA with regard to the letter.
On November 7, 2011, Merck received a Complete Response letter from the FDA for
tafluprost (MK-2452). The Company plans to have further discussions with the FDA with regard
to the letter.
In September 2011, the FDA accepted for filing and review the NDA for ridaforolimus, an
investigational oral mTOR inhibitor under development for the treatment of metastatic soft-tissue
or bone sarcomas in patients who had a favorable response to chemotherapy. The FDA assigned a
Standard review classification to this application. In August 2011, the European Medicines Agency
accepted the marketing authorization application for ridaforolimus. As part of an exclusive
license agreement with ARIAD, Merck is responsible for the development and worldwide
commercialization of ridaforolimus in oncology. ARIAD intends to co-promote ridaforolimus in the
United States.
MK-0653C, Zetia (ezetimibe) combined with atorvastatin was accepted for standard review by the
FDA for the treatment of primary or mixed hyperlipidemia. In response to notice of the Companys
filing, Pfizer Inc. (Pfizer) filed a patent infringement lawsuit in U.S. District Court against
the Company asserting certain Pfizer patent rights in respect of atorvastatin. This lawsuit has
the potential to bar FDA approval of the Companys NDA for up to 30 months (until January 6, 2014)
subject to being shortened or lengthened by a court decision, or shortened by an agreement between
the parties.
The Company is discontinuing the clinical development program for MK-0431C, a combination of
sitagliptin and pioglitazone, for the treatment of diabetes. The decision is based on a review of
the regulatory and commercial prospects for the combination drug candidate.
- 54 -
The chart below reflects the Companys research pipeline as of November 4, 2011. Candidates
shown in Phase III include specific products and the date such candidate entered into Phase III
development. Candidates shown in Phase II include the most advanced compound with a specific
mechanism or, if listed compounds have the same mechanism, they are each currently intended for
commercialization in a given therapeutic area. Small molecules and biologics are given MK-number
designations and vaccine candidates are given V-number designations. Candidates in Phase I, additional indications in the
same therapeutic area and additional claims, line extensions or formulations for in-line products
are not shown.
|
|
|
|
|
Phase II |
|
Phase III (Phase III entry date) |
|
Under Review |
Allergy
MK-8237, Immunotherapy(1)
Cancer
MK-0646 (dalotuzumab)
MK-1775
MK-2206
MK-7965 (dinaciclib)
Contraception, Medicated IUS
MK-8342
Diabetes Mellitus
MK-3102
Hepatitis C
MK-5172
Insomnia
MK-3697
MK-6096
Overactive Bladder
MK-4618
Pneumoconjugate Vaccine
V114
Psoriasis
MK-3222
|
|
Allergy
MK-7243, Grass pollen(1) (March 2008)
MK-3641, Ragweed(1) (September 2009)
Atherosclerosis
MK-0524A
(extended-release niacin/laropiprant) (U.S.) (December 2005)
MK-0524B (extended-release niacin/laropiprant/simvastatin) (July 2007)
MK-0859 (anacetrapib) (May 2008)
Atrial Fibrillation
MK-6621 (vernakalant
I.V.) (U.S.) (August 2003) (2)
Clostridium difficile Infection
MK-3415A (November 2011)
COPD
MK-0887A (Zenhale) (EU) (August 2006)
Diabetes and Atherosclerosis
MK-0431E
(sitagliptin/atorvastatin) (October 2011)
Fertility
MK-8962 (corifollitropin alfa for injection) (U.S.) (July 2006)
Hepatitis C
MK-7009 (vaniprevir)(3) (June 2011)
Herpes Zoster
V212 (inactivated VZV vaccine) (December 2010)
HPV-Related Cancers
V503 (HPV vaccine (9 valent)) (September 2008)
Insomnia
MK-4305 (suvorexant) (December 2009)
Neuromuscular Blockade Reversal
MK-8616 (Bridion) (U.S.) (November 2005)
Osteoporosis
MK-0822 (odanacatib) (September 2007)
Parkinsons Disease
MK-3814 (preladenant) (July 2010)
Pediatric Hexavalent Combination Vaccine
V419 (April 2011)
Thrombosis
MK-5348 (vorapaxar) (September 2007)
|
|
Atherosclerosis
MK-0653C (ezetimibe/atorvastatin) (U.S.)
Contraception
MK-8175A
(NOMAC/E2)(4) (U.S.)
Diabetes Mellitus
MK-0431A XR
(Janumet XR) (sitagliptin/extended-release
metformin) (U.S.)
Glaucoma
MK-2452
(tafluprost)(5) (U.S.)
Sarcoma
MK-8669 (ridaforolimus) (U.S.) (EU)
Footnotes:
(1) North American
rights only.
(2)
Vernakalant I.V. for atrial fibrillation
started Phase III clinical trials in August 2003 sponsored by
Cardiome in collaboration with Astellas.
(3) For development in Japan only.
(4)
On November 4, 2011, Merck received a Complete
Response letter from the FDA for NOMAC/E2 (MK-8175A). The Company
plans to have further discussions with the FDA with regard to the
letter.
(5)
On November 7, 2011, Merck received a Complete Response letter
from the FDA for tafluprost (MK-2452). The Company plans to have
further discussions with the FDA with regard to the letter.
|
- 55 -
Selected Joint Venture and Affiliate Information
AstraZeneca LP
In 1998, Old Merck and Astra completed the restructuring of the ownership and operations of
their existing joint venture whereby Old Merck acquired Astras interest in KBI Inc. (KBI) and
contributed KBIs operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P.
(the Partnership), in exchange for a 1% limited partner interest. Astra contributed the net
assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership in exchange for a 99%
general partner interest. The Partnership, renamed AstraZeneca LP (AZLP) upon Astras 1999 merger
with Zeneca Group Plc (the AstraZeneca merger), became the exclusive distributor of the products
for which KBI retained rights.
In connection with the 1998 restructuring, Astra purchased an option (the Asset Option) for
a payment of $443 million, which was recorded as deferred income, to buy Old Mercks interest in
the KBI products, excluding the gastrointestinal medicines Nexium and Prilosec (the Non-PPI
Products). In April 2010, AstraZeneca exercised the Asset Option. Merck received $647 million
from AstraZeneca, representing the net present value as of March 31, 2008 of projected future
pretax revenue to be received by Old Merck from the Non-PPI Products, which was recorded as a
reduction to the Companys investment in AZLP. The Company recognized the $443 million of deferred
income in the second quarter of 2010 as a component of Other (income) expense, net. In addition,
in 1998, Old Merck granted Astra an option (the Shares Option) to buy Old Mercks common stock
interest in KBI and, therefore, Old Mercks interest in Nexium and Prilosec, exercisable in 2012.
The exercise price for the Shares Option will be based on the net present value of estimated future
net sales of Nexium and Prilosec as determined at the time of exercise, subject to certain true-up
mechanisms. The Company believes that it is likely that AstraZeneca will exercise the Shares
Option. If AstraZeneca does exercise the Shares Option, the Company will no longer record equity
income from AZLP and supply sales to AZLP will decline substantially.
Sanofi Pasteur MSD
In 1994, Old Merck and Pasteur Mérieux Connaught (now Sanofi Pasteur S.A.) established an
equally-owned joint venture to market vaccines in Europe and to collaborate in the development of
combination vaccines for distribution in Europe. Total vaccine sales reported by SPMSD were $375
million and $382 million in the third quarter of 2011 and 2010, respectively, and were $805 million
and $871 million for the first nine months of 2011 and 2010, respectively. The decline for the
year-to-date period reflects in part lower sales of Gardasil. SPMSD sales of Gardasil were $59
million and $79 million for the third quarter of 2011 and 2010, respectively, and were $183 million
and $244 million for the first nine months of 2011 and 2010, respectively.
Johnson & Johnson°Merck Consumer Pharmaceuticals Company
In September 2011, Merck sold its 50% interest in the JJMCP joint venture
to J&J. The venture between Merck and J&J was formed
in 1989 to develop, manufacture, market and distribute certain over-the-counter (OTC) consumer
products in the United States and Canada. Under the agreement, Merck received a one-time payment
of $175 million and recognized a pretax gain of $136 million in the third quarter of 2011 reflected in Other (income) expense, net. Mercks rights to the Pepcid brand outside the United States and Canada were not
affected by this transaction. Following the transaction, J&J owns the ventures assets which
include the exclusive rights to market OTC Pepcid, Mylanta, Mylicon and other local OTC brands
where they are currently sold in the United States and Canada. The partnership assets also included
a manufacturing facility.
The Company records the results from its interest in AZLP and SPMSD in Equity income from
affiliates.
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Cash and investments |
|
$ |
17,999 |
|
|
$ |
14,376 |
|
Working capital |
|
|
17,516 |
|
|
|
13,423 |
|
Total debt to total liabilities and equity |
|
|
17.0 |
% |
|
|
16.9 |
% |
|
During the first nine months of 2011, cash provided by operating activities was $9.2 billion
compared with $7.3 billion in the first nine months of 2010. Cash provided by operating activities
during the first nine months of 2011 reflects the $500 million payment made to J&J as a result of
the arbitration settlement, as well as payments to the Internal Revenue Service (IRS) as a result
of the settlement discussed below. On an ongoing basis, cash
- 56 -
provided by operations will continue to be the Companys primary source of funds to finance
operating needs and capital expenditures. The global economic downturn and the sovereign debt
issues, among other factors, have caused foreign receivables to deteriorate in certain European
countries. While the Company continues to receive payment on these receivables, these conditions
have resulted in an increase in the average length of time it takes to collect accounts receivable
outstanding thereby adversely affecting cash provided by operating activities.
Cash used in investing activities was $1.2 billion in the first nine months of 2011 compared
with $2.5 billion in the first nine months of 2010 primarily reflecting lower purchases of
securities and other investments and higher proceeds from the sales of securities and other
investments. In addition, the Company received proceeds from the disposition of businesses in the
first nine months of 2011. In 2010, the Company received proceeds from AstraZenecas asset option
exercise. Additionally, the Company had a greater use of cash for acquisitions of businesses and
higher capital expenditures in the first nine months of 2011 as compared with the same period in
2010. Cash used in financing activities in the first nine months of 2011 was $4.7 billion compared
with $4.1 billion in the first nine months of 2010. The higher use of cash in financing activities
was primarily driven by higher payments on debt, a decrease in short-term borrowings and lower
proceeds from the exercise of stock options, partially offset by lower purchases of treasury stock.
At September 30, 2011, the total of worldwide cash and investments was $18.0 billion,
including $15.6 billion of cash, cash equivalents and short-term investments and $2.4 billion of
long-term investments. A substantial majority of these cash and investments is held by foreign
subsidiaries and would be subject to significant tax payments if such cash and investments were
repatriated. However, cash provided by operating activities in the United States continues to be
the Companys primary source of funds to finance domestic operating needs, capital expenditures,
treasury stock purchases and dividends paid to shareholders.
In April 2011, the IRS concluded its examination of Old Mercks 2002-2005 federal income tax
returns and as a result the Company was required to make net payments of approximately $465
million. The Companys unrecognized tax benefits for the years under examination exceeded the
adjustments related to this examination period and therefore the Company recorded a net $700
million tax provision benefit in the second quarter of 2011. This net benefit reflects the
decrease of unrecognized tax benefits for the years under examination partially offset by increases
to the unrecognized tax benefits for years subsequent to the examination period as a result of this
settlement. The Company disagrees with the IRS treatment of one issue raised during this
examination and is appealing the matter through the IRS administrative process.
As previously disclosed, the Canada Revenue Agency (CRA) has proposed adjustments for 1999
and 2000 relating to intercompany pricing matters and, in July 2011, the CRA issued assessments for
other miscellaneous audit issues for tax years 2001-2004. These adjustments would increase
Canadian tax due by approximately $330 million (U.S. dollars) plus approximately $370 million (U.S.
dollars) of interest through September 30, 2011. The Company disagrees with the positions taken by
the CRA and believes they are without merit. The Company continues to contest the assessments
through the CRA appeals process. The CRA is expected to prepare similar adjustments for later
years. Management believes that resolution of these matters will not have a material effect on the
Companys financial position or liquidity.
Capital expenditures totaled $1.1 billion and $1.0 billion for the first nine months of 2011
and 2010, respectively. Capital expenditures for full year 2011 are estimated to be $1.8 billion.
Dividends paid to stockholders were $3.5 billion and $3.6 billion for the first nine months of
2011 and 2010, respectively. In May and July 2011, the Board of Directors declared a quarterly
dividend of $0.38 per share on the Companys common stock for the third and fourth quarters of
2011.
In April 2011, Merck announced that its Board of Directors approved additional purchases of up
to $5 billion of Mercks common stock for its treasury. The Company purchased $1.4 billion of its
common stock (41 million shares) for its treasury during the first nine months of 2011. The
Company has approximately $5.0 billion remaining under this program and the previous November 2009
treasury stock purchase authorization. The treasury stock purchases have no time limit and will be
made over time on the open market, in block transactions or in privately negotiated transactions.
In May 2011, the Company entered into a new $2.0 billion, 364-day credit facility and a new
$2.0 billion four-year credit facility maturing in May 2015. The Company terminated its existing
$2.0 billion, 364-day credit facility which expired in May 2011 and its $2.0 billion revolving
credit facility that was scheduled to mature in
- 57 -
August 2012. Both outstanding facilities provide
backup liquidity for the Companys commercial paper borrowing facility and are to be used for
general corporate purposes. The Company has not drawn funding from either facility.
During the third quarter of
2011, the Company entered into a transaction which will require the
Company to make
future bulk supply purchases of $150 million in the aggregate through 2016, although this
period may be extended in certain circumstances.
Critical Accounting Policies
The Companys significant accounting policies, which include managements best estimates and
judgments, are included in Note 2 to the consolidated financial statements for the year ended
December 31, 2010 included in Mercks Form 10-K filed on February 28, 2011. Certain of these
accounting policies are considered critical as disclosed in the Critical Accounting Policies and
Other Matters section of Managements Discussion and Analysis of Financial Condition and Results of
Operations included in Mercks Form 10-K because of the potential for a significant impact on the
financial statements due to the inherent uncertainty in such estimates. There have been no
significant changes in the Companys critical accounting policies since December 31, 2010 other
than with respect to guidance on revenue recognition adopted on January 1, 2011 as discussed in
Note 1 to the interim consolidated financial statements.
Item 4. Controls and Procedures
Management of the Company, with the participation of its Chief Executive Officer and Chief
Financial Officer, has evaluated the effectiveness of the Companys disclosure controls and
procedures over financial reporting for the period covered by this Form 10-Q. Based on this
assessment, the Companys Chief Executive Officer and Chief Financial Officer have concluded that
as of September 30, 2011, the Companys disclosure controls and procedures are effective. As
previously disclosed, the Company is continuing its plans for integration of its business
operations and the implementation of an enterprise wide resource planning system (SAP). These
process modifications, which included several of the Companys
major European markets during 2011, affect the design and operation of controls over financial reporting. With each
implementation, the Company continues to monitor the status of the business and financial operations and
believes that an effective control environment has been maintained post-implementation.
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS
This report and other written reports and oral statements made from time to time by the
Company may contain so-called forward-looking statements, all of which are based on managements
current expectations and are subject to risks and uncertainties which may cause results to differ
materially from those set forth in the statements. One can identify these forward-looking
statements by their use of words such as anticipates, expects, plans, will, estimates,
forecasts, projects and other words of similar meaning. One can also identify them by the fact
that they do not relate strictly to historical or current facts. These statements are likely to
address the Companys growth strategy, financial results, product development, product approvals,
product potential and development programs. One must carefully consider any such statement and
should understand that many factors could cause actual results to differ materially from the
Companys forward-looking statements. These factors include inaccurate assumptions and a broad
variety of other risks and uncertainties, including some that are known and some that are not. No
forward-looking statement can be guaranteed and actual future results may vary materially.
The Company does not assume the obligation to update any forward-looking statement. One
should carefully evaluate such statements in light of factors, including risk factors, described in
the Companys filings with the Securities and Exchange Commission, especially on Forms 10-K, 10-Q
and 8-K. In Item 1A. Risk Factors of the Companys Annual Report on Form 10-K for the year ended
December 31, 2010, as filed on February 28, 2011, the Company discusses in more detail various
important risk factors that could cause actual results to differ from expected or historic results.
The Company notes these factors for investors as permitted by the Private Securities Litigation
Reform Act of 1995. One should understand that it is not possible to predict or identify all such
factors. Consequently, the reader should not consider any such list to be a complete statement of
all potential risks or uncertainties.
- 58 -
PART II Other Information
Item 1. Legal Proceedings
The information called for by this Item is incorporated herein by reference to Note 9 included
in Part I, Item 1, Financial Statements (unaudited) Notes to Consolidated Financial Statements.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer purchases of equity securities for the three months ended September 30, 2011 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 |
|
|
2,991,702 |
|
|
$ |
35.70 |
|
|
$ |
5,985 |
|
August 1 - August 31 |
|
|
15,000,293 |
|
|
$ |
31.69 |
|
|
$ |
5,510 |
|
September 1 - September 30 |
|
|
14,410,264 |
|
|
$ |
32.13 |
|
|
$ |
5,047 |
|
Total |
|
|
32,402,259 |
|
|
$ |
32.25 |
|
|
$ |
5,047 |
|
|
|
|
(1) |
|
All shares purchased during the period were made as part of plans approved by
the Board of Directors in November 2009 to purchase up to $3 billion in Merck shares and in April
2011 to purchase up to $5 billion in Merck shares. |
- 59 -
Item 6. Exhibits
|
|
|
|
|
Number |
|
Description |
|
3.1 |
|
|
Restated Certificate of Incorporation of Merck & Co., Inc. (November
3, 2009) Incorporated by reference to Current Report on Form 8-K
filed on November 4, 2009 |
|
|
|
|
|
|
3.2 |
|
|
By-Laws of Merck & Co., Inc. (effective November 3, 2009)
Incorporated by reference to Current Report on Form 8-K filed November
4, 2009 |
|
|
|
|
|
|
31.1 |
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Executive Officer |
|
|
|
|
|
|
31.2 |
|
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Financial Officer |
|
|
|
|
|
|
32.1 |
|
|
Section 1350 Certification of Chief Executive Officer |
|
|
|
|
|
|
32.2 |
|
|
Section 1350 Certification of Chief Financial Officer |
|
|
|
|
|
|
101 |
|
|
The following materials from Merck & Co., Inc.s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2011, formatted in XBRL
(Extensible Business Reporting Language): (i) the Consolidated
Statement of Income, (ii) the Consolidated Balance Sheet, (iii) the
Consolidated Statement of Cash Flows, and (iv) Notes to Consolidated
Financial Statements. |
- 60 -
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 8, 2011 |
/s/ Bruce N. Kuhlik
|
|
|
BRUCE N. KUHLIK |
|
|
Executive Vice President and General Counsel |
|
|
|
|
Date: November 8, 2011 |
/s/ John Canan
|
|
|
JOHN CANAN |
|
|
Senior Vice President Finance - Global Controller |
|
- 61 -
EXHIBIT INDEX
|
|
|
Number |
|
Description |
|
3.1 |
|
Restated Certificate of Incorporation of Merck & Co., Inc. (November
3, 2009) Incorporated by reference to Current Report on Form 8-K
filed on November 4, 2009 |
|
|
|
3.2 |
|
By-Laws of Merck & Co., Inc. (effective November 3, 2009)
Incorporated by reference to Current Report on Form 8-K filed November
4, 2009 |
|
|
|
31.1 |
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Executive Officer |
|
|
|
31.2 |
|
Rule 13a 14(a)/15d 14(a) Certification of Chief Financial Officer |
|
|
|
32.1 |
|
Section 1350 Certification of Chief Executive Officer |
|
|
|
32.2 |
|
Section 1350 Certification of Chief Financial Officer |
|
|
|
101 |
|
The following materials from Merck & Co., Inc.s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2011, formatted in XBRL
(Extensible Business Reporting Language): (i) the Consolidated
Statement of Income, (ii) the Consolidated Balance Sheet, (iii) the
Consolidated Statement of Cash Flows, and (iv) Notes to Consolidated
Financial Statements. |
- 62 -