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 June 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 |
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Identification No. 22-1918501 |
The number of shares of common stock outstanding as of the close of business on July 29, 2011:
3,080,796,992
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
(Do not check if a smaller reporting company)
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
TABLE OF CONTENTS
Part I Financial Information
Item 1. Financial Statements
MERCK & CO., INC. AND SUBSIDIARIES
INTERIM CONSOLIDATED STATEMENT OF INCOME
(Unaudited, $ in millions except per share amounts)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 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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$ |
12,151 |
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$ |
11,346 |
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$ |
23,732 |
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$ |
22,768 |
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Costs, Expenses and Other |
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Materials and production |
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4,284 |
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4,549 |
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8,343 |
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9,764 |
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Marketing and administrative |
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3,525 |
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3,175 |
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6,689 |
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6,397 |
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Research and development |
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1,936 |
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2,179 |
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4,094 |
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4,230 |
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Restructuring costs |
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668 |
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526 |
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654 |
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814 |
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Equity income from affiliates |
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(55 |
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(43 |
) |
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(193 |
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(180 |
) |
Other (income) expense, net |
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121 |
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(281 |
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744 |
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(113 |
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10,479 |
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10,105 |
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20,331 |
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20,912 |
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Income Before Taxes |
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1,672 |
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1,241 |
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3,401 |
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1,856 |
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Taxes on Income |
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(382 |
) |
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461 |
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276 |
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746 |
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Net Income |
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$ |
2,054 |
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$ |
780 |
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$ |
3,125 |
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$ |
1,110 |
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Less: Net Income Attributable to Noncontrolling Interests |
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30 |
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28 |
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58 |
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59 |
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Net Income Attributable to Merck & Co., Inc. |
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$ |
2,024 |
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$ |
752 |
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$ |
3,067 |
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$ |
1,051 |
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Basic Earnings per Common Share Attributable to
Merck & Co., Inc. Common Shareholders |
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$ |
0.65 |
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$ |
0.24 |
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$ |
0.99 |
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$ |
0.34 |
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Earnings per Common Share Assuming Dilution Attributable
to Merck & Co., Inc. Common Shareholders |
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$ |
0.65 |
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$ |
0.24 |
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$ |
0.98 |
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$ |
0.33 |
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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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$ |
0.76 |
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$ |
0.76 |
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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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June 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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$ |
12,342 |
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$ |
10,900 |
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Short-term investments |
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1,639 |
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1,301 |
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Accounts receivable (net of allowance for doubtful accounts of $128
in 2011 and $104 in 2010) |
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8,475 |
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7,344 |
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Inventories (excludes inventories of $1,408 in 2011 and $1,194
in 2010 classified in Other assets see Note 6) |
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6,225 |
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5,868 |
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Deferred income taxes and other current assets |
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3,687 |
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3,651 |
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Total current assets |
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32,368 |
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29,064 |
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Investments |
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2,175 |
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2,175 |
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Property,
Plant and Equipment, at cost, net of accumulated depreciation
of $15,195 in 2011 and $13,481 in 2010 |
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16,671 |
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17,082 |
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Goodwill |
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12,382 |
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12,378 |
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Other Intangibles, Net |
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37,065 |
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39,456 |
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Other Assets |
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5,534 |
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5,626 |
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$ |
106,195 |
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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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$ |
2,523 |
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$ |
2,400 |
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Trade accounts payable |
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2,143 |
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2,308 |
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Accrued and other current liabilities |
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8,747 |
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8,514 |
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Income taxes payable |
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1,174 |
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1,243 |
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Dividends payable |
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1,176 |
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1,176 |
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Total current liabilities |
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15,763 |
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15,641 |
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Long-Term Debt |
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15,783 |
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15,482 |
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Deferred Income Taxes and Noncurrent Liabilities |
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16,727 |
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17,853 |
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Merck & Co., Inc. Stockholders Equity |
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Common stock, $0.50 par value
Authorized - 6,500,000,000 shares
Issued - 3,576,948,356 shares in 2011 and 2010 |
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1,788 |
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1,788 |
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Other paid-in capital |
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40,657 |
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40,701 |
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Retained earnings |
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38,243 |
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37,536 |
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Accumulated other comprehensive loss |
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(2,776 |
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(3,216 |
) |
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77,912 |
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76,809 |
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Less treasury stock, at cost
493,935,906 shares in 2011 and 494,841,533 shares in 2010 |
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22,416 |
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22,433 |
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Total Merck & Co., Inc. stockholders equity |
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55,496 |
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54,376 |
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Noncontrolling Interests |
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2,426 |
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2,429 |
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Total equity |
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57,922 |
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56,805 |
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$ |
106,195 |
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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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Six Months Ended |
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June 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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$ |
3,125 |
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$ |
1,110 |
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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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3,663 |
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3,635 |
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Intangible asset impairment charges |
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439 |
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27 |
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Equity income from affiliates |
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(193 |
) |
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(180 |
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Dividends and distributions from equity affiliates |
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121 |
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182 |
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Gain on AstraZeneca asset option exercise |
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(443 |
) |
Deferred income taxes |
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(841 |
) |
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(319 |
) |
Share-based compensation |
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200 |
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274 |
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Other |
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(456 |
) |
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410 |
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Net changes in assets and liabilities |
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(1,485 |
) |
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(5 |
) |
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Net Cash Provided by Operating Activities |
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4,573 |
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4,691 |
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Cash Flows from Investing Activities |
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Capital expenditures |
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(689 |
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(680 |
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Purchases of securities and other investments |
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(3,066 |
) |
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(4,235 |
) |
Proceeds from sales of securities and other investments |
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2,890 |
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|
1,700 |
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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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(141 |
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Proceeds from AstraZeneca option exercise |
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647 |
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Other |
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(28 |
) |
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25 |
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Net Cash Used in Investing Activities |
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(943 |
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(2,684 |
) |
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Cash Flows from Financing Activities |
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Net change in short-term borrowings |
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1,396 |
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|
1,658 |
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Payments on debt |
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(1,265 |
) |
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(626 |
) |
Purchases of treasury stock |
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(314 |
) |
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(1,297 |
) |
Dividends paid to stockholders |
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(2,351 |
) |
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(2,378 |
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Proceeds from exercise of stock options |
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162 |
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237 |
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Other |
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(57 |
) |
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(115 |
) |
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Net Cash Used in Financing Activities |
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(2,429 |
) |
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(2,521 |
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Effect of Exchange Rate Changes on Cash and Cash Equivalents |
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241 |
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(131 |
) |
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Net Increase (Decrease) in Cash and Cash Equivalents |
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1,442 |
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(645 |
) |
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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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$ |
12,342 |
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$ |
8,666 |
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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) completed their previously-announced merger (the Merger). In the Merger,
Schering-Plough acquired all of the shares of Old Merck, which became a wholly owned subsidiary of
Schering-Plough and was renamed Merck Sharp & Dohme Corp. Schering-Plough continued as the
surviving public company and was renamed Merck & Co., Inc. (New Merck or the Company).
However, for accounting purposes only, the Merger was treated as an acquisition with Old Merck
considered the accounting acquirer. 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. The adoption of this new guidance will not impact the Companys financial position,
results of operations or cash flows.
- 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 next 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 $808 million and $830 million in the
second quarter of 2011 and 2010, respectively, and $921 million and $1.1 billion for the first six
months of 2011 and 2010, respectively, related to this program. Since inception of the Merger
Restructuring Program through June 30, 2011, Merck has recorded total pretax accumulated costs of
approximately $4.2 billion and eliminated approximately 12,900 positions comprised of employee
separations, as well as the elimination of contractors and over 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 by the end of 2011.
Pretax restructuring costs of $1 million and $66 million were recorded in the second quarter of
2011 and 2010, respectively, and $5 million and $131 million in the first six months of 2011 and
2010, respectively, related to the 2008 Restructuring Program. Since inception of the 2008
Restructuring Program through June 30, 2011, Merck has recorded total pretax accumulated costs of
$1.6 billion and eliminated approximately 5,980 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, except for certain manufacturing-related
actions, with the total cumulative pretax costs estimated to be up to $2.0 billion. The Company estimates that two-thirds of the cumulative pretax costs relate to cash
outlays, primarily from employee separation expense. Approximately one-third of the cumulative
pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be
closed or divested.
- 6 -
Notes to Consolidated Financial Statements (unaudited) (continued)
For segment reporting, restructuring charges are unallocated expenses.
The following tables summarize the charges related to Merger Restructuring Program and 2008
Restructuring Program activities by type of cost:
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Three Months Ended June 30, 2011 |
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Six Months Ended June 30, 2011 |
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Separation |
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Accelerated |
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Separation |
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Accelerated |
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($ 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 |
|
$ |
|
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|
$ |
91 |
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|
$ |
5 |
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|
$ |
96 |
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|
$ |
|
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|
$ |
152 |
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$ |
5 |
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$ |
157 |
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Marketing and administrative |
|
|
|
|
|
|
22 |
|
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|
1 |
|
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|
23 |
|
|
|
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|
45 |
|
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|
1 |
|
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46 |
|
Research and development |
|
|
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|
38 |
|
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(22 |
) |
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16 |
|
|
|
|
|
|
|
80 |
|
|
|
(19 |
) |
|
|
61 |
|
Restructuring costs |
|
|
646 |
|
|
|
|
|
|
|
27 |
|
|
|
673 |
|
|
|
607 |
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|
|
50 |
|
|
|
657 |
|
|
|
|
|
646 |
|
|
|
151 |
|
|
|
11 |
|
|
|
808 |
|
|
|
607 |
|
|
|
277 |
|
|
|
37 |
|
|
|
921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
|
|
|
|
|
4 |
|
|
|
2 |
|
|
|
6 |
|
|
|
|
|
|
|
6 |
|
|
|
2 |
|
|
|
8 |
|
Restructuring costs |
|
|
(7 |
) |
|
|
|
|
|
|
2 |
|
|
|
(5 |
) |
|
|
(8 |
) |
|
|
|
|
|
|
5 |
|
|
|
(3 |
) |
|
|
|
|
(7 |
) |
|
|
4 |
|
|
|
4 |
|
|
|
1 |
|
|
|
(8 |
) |
|
|
6 |
|
|
|
7 |
|
|
|
5 |
|
|
|
|
$ |
639 |
|
|
$ |
155 |
|
|
$ |
15 |
|
|
$ |
809 |
|
|
$ |
599 |
|
|
$ |
283 |
|
|
$ |
44 |
|
|
$ |
926 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2010 |
|
|
Six Months Ended June 30, 2010 |
|
|
|
Separation |
|
|
Accelerated |
|
|
|
|
|
|
|
|
|
|
Separation |
|
|
Accelerated |
|
|
|
|
|
|
|
($ in millions) |
|
Costs |
|
|
Depreciation |
|
|
Other |
|
|
Total |
|
|
Costs |
|
|
Depreciation |
|
|
Other |
|
|
Total |
|
|
Merger Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
$ |
|
|
|
$ |
149 |
|
|
$ |
22 |
|
|
$ |
171 |
|
|
$ |
|
|
|
$ |
174 |
|
|
$ |
22 |
|
|
$ |
196 |
|
Research and development |
|
|
|
|
|
|
113 |
|
|
|
31 |
|
|
|
144 |
|
|
|
|
|
|
|
113 |
|
|
|
37 |
|
|
|
150 |
|
Restructuring costs |
|
|
374 |
|
|
|
41 |
|
|
|
100 |
|
|
|
515 |
|
|
|
583 |
|
|
|
41 |
|
|
|
143 |
|
|
|
767 |
|
|
|
|
|
374 |
|
|
|
303 |
|
|
|
153 |
|
|
|
830 |
|
|
|
583 |
|
|
|
328 |
|
|
|
202 |
|
|
|
1,113 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
|
|
|
|
|
11 |
|
|
|
36 |
|
|
|
47 |
|
|
|
|
|
|
|
40 |
|
|
|
36 |
|
|
|
76 |
|
Restructuring costs |
|
|
12 |
|
|
|
|
|
|
|
7 |
|
|
|
19 |
|
|
|
31 |
|
|
|
|
|
|
|
24 |
|
|
|
55 |
|
|
|
|
|
12 |
|
|
|
11 |
|
|
|
43 |
|
|
|
66 |
|
|
|
31 |
|
|
|
40 |
|
|
|
60 |
|
|
|
131 |
|
|
|
|
$ |
386 |
|
|
$ |
314 |
|
|
$ |
196 |
|
|
$ |
896 |
|
|
$ |
614 |
|
|
$ |
368 |
|
|
$ |
262 |
|
|
$ |
1,244 |
|
|
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 six
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 second quarter of 2011 and 2010, approximately
585 positions and 2,435 positions, respectively, were eliminated under the Merger Restructuring
Program and approximately 60 positions and 240 positions, respectively, were eliminated under the
2008 Restructuring Program. In the first six months of 2011 and 2010,
approximately 1,335
positions and 7,585 positions, respectively, were eliminated under the Merger Restructuring Program
and approximately 180 positions and 775 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.
Other
activity in the second quarter of 2011 and 2010 includes asset abandonment, shut-down and
other related costs. Additionally, other activity includes employee-related costs such as
curtailment, settlement and termination charges associated with pension and other postretirement
benefit plans (see Note 12) and share-based compensation costs.
- 7 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The following table summarizes the charges and spending relating to Merger Restructuring
Program and 2008 Restructuring Program activities for the six months ended June 30, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Separation |
|
|
Accelerated |
|
|
|
|
|
|
|
($ in millions) |
|
Costs |
|
|
Depreciation |
|
|
Other |
|
|
Total |
|
|
Merger Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring reserves January 1, 2011 |
|
$ |
859 |
|
|
$ |
|
|
|
$ |
64 |
|
|
$ |
923 |
|
Expense |
|
|
607 |
|
|
|
277 |
|
|
|
37 |
|
|
|
921 |
|
(Payments) receipts, net |
|
|
(257 |
) |
|
|
|
|
|
|
(71 |
) |
|
|
(328 |
) |
Non-cash activity |
|
|
|
|
|
|
(277 |
) |
|
|
16 |
|
|
|
(261 |
) |
|
Restructuring reserves June 30, 2011 (1) |
|
$ |
1,209 |
|
|
$ |
|
|
|
$ |
46 |
|
|
$ |
1,255 |
|
|
2008 Restructuring Program |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring reserves January 1, 2011 |
|
$ |
196 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
196 |
|
Expense |
|
|
(8 |
) |
|
|
6 |
|
|
|
7 |
|
|
|
5 |
|
(Payments) receipts, net |
|
|
(13 |
) |
|
|
|
|
|
|
(2 |
) |
|
|
(15 |
) |
Non-cash activity |
|
|
|
|
|
|
(6 |
) |
|
|
(5 |
) |
|
|
(11 |
) |
|
Restructuring reserves June 30, 2011 (1) |
|
$ |
175 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
175 |
|
|
|
|
|
(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 $7 million and $6 million for the second
quarter of 2011 and 2010, respectively, and $16 million and $9 million for the first six months of
2011 and 2010, respectively. In addition, the second quarter and first six 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 $38 million at June 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 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 six
months of 2011 reflected in Other (income) expense, net.
- 8 -
Notes to Consolidated Financial Statements (unaudited) (continued)
4. Collaborative Arrangements
The Company continues its strategy of establishing external alliances to complement its
substantial internal research capabilities, including research collaborations, licensing
preclinical and clinical compounds and technology platforms to drive both near- and long-term
growth. The Company supplements its internal research with a licensing and external alliance
strategy focused on the entire spectrum of collaborations from early research to late-stage
compounds, as well as new technologies across a broad range of therapeutic areas. These
arrangements often include upfront payments and royalty or profit share payments, contingent upon
the occurrence of certain future events linked to the success of the asset in development, as well
as expense reimbursements or payments to the third party.
Cozaar/Hyzaar
In 1989, Old Merck and E.I. duPont de Nemours and Company (DuPont) agreed to form a
long-term research and marketing collaboration to develop a class of therapeutic agents for high
blood pressure and heart disease, discovered by DuPont, called angiotensin II receptor antagonists,
which include Cozaar and Hyzaar. In return, Old Merck provided DuPont marketing rights in the
United States and Canada to its prescription medicines, Sinemet and Sinemet CR (the Company has
since regained global marketing rights to Sinemet and Sinemet CR). Pursuant to a 1994 agreement
with DuPont, the Company has an exclusive licensing agreement to market Cozaar and Hyzaar, which
are both registered trademarks of DuPont, in return for royalties and profit share payments to
DuPont. The patents that provided market exclusivity in the United States for Cozaar and Hyzaar
expired in April 2010. In addition, Cozaar and Hyzaar lost patent protection in a number of major
European markets in March 2010.
Remicade/Simponi
In 1998, a subsidiary of Schering-Plough entered into a licensing agreement with Centocor
Ortho Biotech Inc. (Centocor), a Johnson & Johnson company, to market Remicade, which is
prescribed for the treatment of inflammatory diseases. In 2005, Schering-Ploughs subsidiary
exercised an option under its contract with Centocor for license rights to develop and
commercialize Simponi (golimumab), a fully human monoclonal antibody. The Company had exclusive
marketing rights to both products outside the United States, Japan and certain other Asian markets.
In December 2007, Schering-Plough and Centocor revised their distribution agreement regarding the
development, commercialization and distribution of both Remicade and Simponi, extending the
Companys rights to exclusively market Remicade to match the duration of the Companys exclusive
marketing rights for Simponi. In addition, Schering-Plough and Centocor agreed to share certain
development costs relating to Simponis auto-injector delivery system. On October 6, 2009, the
European Commission approved Simponi as a treatment for rheumatoid arthritis and other immune
system disorders in two presentations a novel auto-injector and a prefilled syringe. As a
result, the Companys marketing rights for both products extend for 15 years from the first
commercial sale of Simponi in the European Union (EU) following the receipt of pricing and
reimbursement approval within the EU. In April 2011, Merck and Johnson & Johnson reached agreement
to amend the distribution rights to Remicade and Simponi. Under the terms of the amended
distribution agreement, Merck relinquished exclusive marketing rights for Remicade and Simponi to
Johnson & Johnson in territories including Canada, Central and South America, the Middle East,
Africa and Asia Pacific effective July 1, 2011. Merck 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 Johnson & Johnson. Under the prior terms of
the distribution agreement, the contribution income (profit) split, which was at 58% to Merck and
42% percent to Johnson & Johnson, would have declined for Merck and increased for Johnson & Johnson
each year until 2014, when it would have been equally divided. Johnson & Johnson also received a
one-time payment of $500 million in April 2011, which the
Company recorded as 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 June 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 varying from March 2015 to June 2019, to floating rate instruments. As a
result of the 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 June 30, 2011, the Company was a party to 13 pay-floating, receive-fixed interest rate swap
contracts designated as fair value hedges of fixed-rate notes in which the notional amounts match
the amount of the hedged fixed-rate notes. There are two swaps maturing in 2011 with notional
amounts of $125 million each that effectively convert the Companys $250 million, 5.125% fixed-rate
notes due 2011 to floating rate instruments. There are five swaps maturing in 2015 with notional
amounts of $150 million each that effectively convert $750 million of the Companys 4.0% fixed-rate
notes due 2015 to floating rate instruments. There are six swaps maturing in 2016, two of which
have notional amounts of $175 million each, and four of which have notional amounts of $125 million
each, that effectively convert the Companys $850 million, 2.25% fixed-rate notes due 2016 to
floating rate instruments. The interest rate swap contracts are designated hedges of the fair
value changes in the notes attributable to changes in the benchmark London Interbank Offered Rate
(LIBOR) swap rate. The fair value changes in the notes attributable to changes in the benchmark
interest rate are recorded in interest expense and offset by the fair value changes in the swap
contracts. The cash flows from these contracts are reported as operating activities in the
Consolidated Statement of Cash Flows.
Presented in the table below is the fair value of derivatives segregated between those
derivatives that are designated as hedging instruments and those that are not designated as hedging
instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
December 31, 2010 |
|
|
|
|
|
Fair Value of Derivative |
|
|
U.S. Dollar |
|
|
Fair Value of Derivative |
|
|
U.S. Dollar |
|
($ 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 |
|
$ |
91 |
|
|
$ |
|
|
|
$ |
3,696 |
|
|
$ |
167 |
|
|
$ |
|
|
|
$ |
2,344 |
|
Foreign exchange contracts (non-current) |
|
Other assets |
|
|
288 |
|
|
|
|
|
|
|
4,469 |
|
|
|
310 |
|
|
|
|
|
|
|
3,720 |
|
Foreign exchange contracts (current) |
|
Accrued and other current liabilities |
|
|
|
|
|
|
40 |
|
|
|
1,825 |
|
|
|
|
|
|
|
18 |
|
|
|
1,505 |
|
Foreign exchange contracts (non-current) |
|
Deferred income taxes and noncurrent liabilities |
|
|
|
|
|
|
3 |
|
|
|
113 |
|
|
|
|
|
|
|
6 |
|
|
|
503 |
|
Interest rate swaps (current) |
|
Deferred income taxes and other current assets |
|
|
6 |
|
|
|
|
|
|
|
250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swaps (non-current) |
|
Other assets |
|
|
66 |
|
|
|
|
|
|
|
1,600 |
|
|
|
56 |
|
|
|
|
|
|
|
1,000 |
|
Interest rate swaps (non-current) |
|
Deferred income taxes and noncurrent liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 |
|
|
|
850 |
|
|
|
|
|
|
$ |
451 |
|
|
$ |
43 |
|
|
$ |
11,953 |
|
|
$ |
533 |
|
|
$ |
31 |
|
|
$ |
9,922 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives Not Designated as Hedging Instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts (current) |
|
Deferred income taxes and other current assets |
|
$ |
106 |
|
|
$ |
|
|
|
$ |
7,894 |
|
|
$ |
95 |
|
|
$ |
|
|
|
$ |
6,295 |
|
|
Foreign exchange contracts (current) |
|
Accrued and other current liabilities |
|
|
|
|
|
|
25 |
|
|
|
3,736 |
|
|
|
|
|
|
|
30 |
|
|
|
4,229 |
|
|
|
|
|
|
$ |
106 |
|
|
$ |
25 |
|
|
$ |
11,630 |
|
|
$ |
95 |
|
|
$ |
30 |
|
|
$ |
10,524 |
|
|
|
|
|
|
$ |
557 |
|
|
$ |
68 |
|
|
$ |
23,583 |
|
|
$ |
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 hedging relationship (net
investment hedge) and (iv) not designated in a hedging relationship:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 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 |
|
$ |
(126 |
) |
|
$ |
(13 |
) |
|
$ |
(163 |
) |
|
$ |
(35 |
) |
Amount of loss recognized in Other (income)
expense, net on hedged item |
|
|
126 |
|
|
|
13 |
|
|
|
163 |
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives designated in foreign currency cash flow hedging relationships |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of loss (gain) reclassified from AOCI to Sales |
|
|
20 |
|
|
|
(5 |
) |
|
|
27 |
|
|
|
14 |
|
Amount of loss (gain) recognized in OCI on derivatives |
|
|
69 |
|
|
|
(190 |
) |
|
|
252 |
|
|
|
(284 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives designated in foreign currency net investment hedging relationships |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of gain recognized in Other (income) expense,
net on derivatives (1) |
|
|
(2 |
) |
|
|
|
|
|
|
(8 |
) |
|
|
|
|
Amount of loss recognized in OCI on derivatives |
|
|
33 |
|
|
|
|
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated in a hedging relationship |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of loss (gain) recognized in Other (income)
expense, net on derivatives (2) |
|
|
33 |
|
|
|
(117 |
) |
|
|
349 |
|
|
|
(185 |
) |
Amount of gain recognized in Sales on hedged item |
|
|
|
|
|
|
(46 |
) |
|
|
|
|
|
|
(113 |
) |
|
|
|
|
(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 June 30, 2011, the Company estimates $107 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) |
|
June 30, 2011 |
|
|
December 31, 2010 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial paper |
|
$ |
|
|
|
$ |
1,411 |
|
|
$ |
|
|
|
$ |
1,411 |
|
|
$ |
|
|
|
$ |
1,046 |
|
|
$ |
|
|
|
$ |
1,046 |
|
Corporate notes and bonds |
|
|
|
|
|
|
1,377 |
|
|
|
|
|
|
|
1,377 |
|
|
|
|
|
|
|
1,133 |
|
|
|
|
|
|
|
1,133 |
|
U.S. government and
agency securities |
|
|
|
|
|
|
523 |
|
|
|
|
|
|
|
523 |
|
|
|
|
|
|
|
500 |
|
|
|
|
|
|
|
500 |
|
Municipal securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
361 |
|
|
|
|
|
|
|
361 |
|
Asset-backed securities (1) |
|
|
|
|
|
|
183 |
|
|
|
|
|
|
|
183 |
|
|
|
|
|
|
|
171 |
|
|
|
|
|
|
|
171 |
|
Mortgage-backed securities
(1) |
|
|
|
|
|
|
134 |
|
|
|
|
|
|
|
134 |
|
|
|
|
|
|
|
99 |
|
|
|
13 |
|
|
|
112 |
|
Foreign government bonds |
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
10 |
|
Equity securities |
|
|
96 |
|
|
|
31 |
|
|
|
|
|
|
|
127 |
|
|
|
117 |
|
|
|
23 |
|
|
|
|
|
|
|
140 |
|
Other debt securities |
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
96 |
|
|
|
3,718 |
|
|
|
|
|
|
|
3,814 |
|
|
|
117 |
|
|
|
3,346 |
|
|
|
13 |
|
|
|
3,476 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities held for employee
compensation |
|
|
197 |
|
|
|
|
|
|
|
|
|
|
|
197 |
|
|
|
181 |
|
|
|
|
|
|
|
|
|
|
|
181 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative assets (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased currency options |
|
|
|
|
|
|
379 |
|
|
|
|
|
|
|
379 |
|
|
|
|
|
|
|
477 |
|
|
|
|
|
|
|
477 |
|
Forward exchange contracts |
|
|
|
|
|
|
106 |
|
|
|
|
|
|
|
106 |
|
|
|
|
|
|
|
95 |
|
|
|
|
|
|
|
95 |
|
Interest rate swaps |
|
|
|
|
|
|
72 |
|
|
|
|
|
|
|
72 |
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
|
|
557 |
|
|
|
|
|
|
|
557 |
|
|
|
|
|
|
|
628 |
|
|
|
|
|
|
|
628 |
|
|
Total assets |
|
$ |
293 |
|
|
$ |
4,275 |
|
|
$ |
|
|
|
$ |
4,568 |
|
|
$ |
298 |
|
|
$ |
3,974 |
|
|
$ |
13 |
|
|
$ |
4,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative liabilities (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Written currency options |
|
$ |
|
|
|
$ |
6 |
|
|
$ |
|
|
|
$ |
6 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Forward exchange contracts |
|
|
|
|
|
|
62 |
|
|
|
|
|
|
|
62 |
|
|
|
|
|
|
|
54 |
|
|
|
|
|
|
|
54 |
|
Interest rate swaps |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 |
|
|
|
|
|
|
|
7 |
|
|
Total liabilities |
|
$ |
|
|
|
$ |
68 |
|
|
$ |
|
|
|
$ |
68 |
|
|
$ |
|
|
|
$ |
61 |
|
|
$ |
|
|
|
$ |
61 |
|
|
|
|
|
(1) |
|
Substantially all of the asset-backed securities are highly-rated (Standard & Poors
rating of AAA and Moodys Investors Service rating of Aaa), secured primarily by credit card,
auto loan, and home equity receivables, with weighted-average lives of primarily 5 years or
less. Mortgage-backed securities represent AAA-rated securities issued or unconditionally
guaranteed as to payment of principal and interest by U.S. government agencies. |
|
(2) |
|
The fair value determination of derivatives includes an assessment of the credit
risk of counterparties to the derivatives and the Companys own credit risk, the effects of
which were not significant. |
There were no significant transfers between Level 1 and Level 2 during the second quarter
or first six months of 2011. As of June 30, 2011, Cash and cash equivalents of $12.3 billion
included $11.8 billion of cash equivalents.
Level 3 Valuation Techniques:
Financial assets are considered Level 3 when their fair values are determined using pricing
models, discounted cash flow methodologies or similar techniques and at least one significant model
assumption or input is unobservable. Level 3 financial assets also include certain investment
securities for which there is limited market activity such that the determination of fair value
requires significant judgment or estimation. The Companys Level
3 investment securities included certain mortgage-backed securities that were valued primarily
using pricing models for which management understands the methodologies. These models incorporate
transaction details such as contractual terms, maturity, timing and amount of future cash inflows,
as well as assumptions about liquidity and credit valuation adjustments of marketplace
participants.
- 14 -
Notes to Consolidated Financial Statements (unaudited) (continued)
The table below provides a summary of the changes in fair value of all financial assets
measured at fair value on a recurring basis using significant unobservable inputs (Level 3):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Beginning balance |
|
$ |
|
|
|
$ |
20 |
|
|
$ |
13 |
|
|
$ |
72 |
|
Sales |
|
|
|
|
|
|
(8 |
) |
|
|
(13 |
) |
|
|
(61 |
) |
Settlements |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
Total realized and unrealized gains (losses) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (1) |
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
18 |
|
Comprehensive income |
|
|
|
|
|
|
(1 |
) |
|
|
|
|
|
|
(10 |
) |
|
Ending balance |
|
$ |
|
|
|
$ |
17 |
|
|
$ |
|
|
|
$ |
17 |
|
|
Losses recorded in earnings for Level 3
assets still held at June 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
June 30, 2011 was $18.8 billion compared with a carrying value of $18.3 billion and at December 31,
2010 was $18.7 billion compared with a carrying value of $17.9 billion. Fair value was estimated
using quoted dealer prices.
A summary of gross unrealized gains and losses on available-for-sale investments recorded in
AOCI is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
December 31, 2010 |
|
|
Fair |
|
|
Amortized |
|
|
Gross Unrealized |
|
Fair |
|
|
Amortized |
|
|
Gross Unrealized |
($ in millions) |
|
Value |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
|
|
Commercial paper |
|
$ |
1,411 |
|
|
$ |
1,411 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,046 |
|
|
$ |
1,046 |
|
|
$ |
|
|
|
$ |
|
|
Corporate notes and bonds |
|
|
1,377 |
|
|
|
1,363 |
|
|
|
15 |
|
|
|
(1 |
) |
|
|
1,133 |
|
|
|
1,124 |
|
|
|
12 |
|
|
|
(3 |
) |
U.S. government and agency
securities |
|
|
523 |
|
|
|
523 |
|
|
|
2 |
|
|
|
(2 |
) |
|
|
500 |
|
|
|
501 |
|
|
|
1 |
|
|
|
(2 |
) |
Municipal securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
361 |
|
|
|
359 |
|
|
|
4 |
|
|
|
(2 |
) |
Asset-backed securities |
|
|
183 |
|
|
|
182 |
|
|
|
1 |
|
|
|
|
|
|
|
171 |
|
|
|
170 |
|
|
|
1 |
|
|
|
|
|
Mortgage-backed securities |
|
|
134 |
|
|
|
134 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
112 |
|
|
|
108 |
|
|
|
5 |
|
|
|
(1 |
) |
Foreign government bonds |
|
|
56 |
|
|
|
56 |
|
|
|
|
|
|
|
|
|
|
|
10 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
Other debt securities |
|
|
3 |
|
|
|
1 |
|
|
|
2 |
|
|
|
|
|
|
|
3 |
|
|
|
1 |
|
|
|
2 |
|
|
|
|
|
Equity securities |
|
|
324 |
|
|
|
307 |
|
|
|
17 |
|
|
|
|
|
|
|
321 |
|
|
|
295 |
|
|
|
34 |
|
|
|
(8 |
) |
|
|
|
$ |
4,011 |
|
|
$ |
3,977 |
|
|
$ |
38 |
|
|
$ |
(4 |
) |
|
$ |
3,657 |
|
|
$ |
3,614 |
|
|
$ |
59 |
|
|
$ |
(16 |
) |
|
Available-for-sale debt securities included in Short-term investments totaled $1.6 billion at
June 30, 2011. Of the remaining debt securities, $1.8 billion mature within five years. At June
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 half 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 our financial position or results of operations.
In the second quarter of 2011, the Companys accounts receivable in Greece, Italy, Spain and Portugal totaled
approximately $1.8 billion of which hospital and public sector receivables were
approximately 75%. As of June 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.
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 June
30, 2011 and December 31, 2010, the Company had received cash collateral of $114 million and $157
million, respectively, from various counterparties which is recorded in Accrued and other current
liabilities. The Company had not advanced any cash collateral to counterparties as of June 30,
2011 or December 31, 2010.
6. Inventories
Inventories consisted of:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Finished goods |
|
$ |
1,440 |
|
|
$ |
1,484 |
|
Raw materials and work in process |
|
|
6,036 |
|
|
|
5,449 |
|
Supplies |
|
|
298 |
|
|
|
315 |
|
|
Total (approximates current cost) |
|
|
7,774 |
|
|
|
7,248 |
|
Reduction to LIFO costs |
|
|
(141 |
) |
|
|
(186 |
) |
|
|
|
$ |
7,633 |
|
|
$ |
7,062 |
|
|
Recognized as: |
|
|
|
|
|
|
|
|
Inventories |
|
$ |
6,225 |
|
|
$ |
5,868 |
|
Other assets |
|
|
1,408 |
|
|
|
1,194 |
|
|
As of June 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 June 30,
2011 and at 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 $111 million and $197 million at June 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 second quarter 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 second quarter and first six
months of 2011, the Company recorded $19 million and $321 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 deemed to have no alternative use in the period. During the first six
months of 2010, the Company recorded $27 million of IPR&D impairment charges attributable to
compounds identified during the Companys pipeline prioritization review that were abandoned and
determined to have either no alternative use or were returned to the respective licensor. The
Company may recognize additional non-cash impairment charges in the future related to marketed
- 16 -
Notes to Consolidated Financial Statements (unaudited) (continued)
products or for the cancellation of other legacy Schering-Plough pipeline programs and such charges
could be material.
8. Joint Ventures and Other Equity Method Affiliates
Equity income from affiliates reflects the performance of the Companys joint ventures and
other equity method affiliates and was comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
AstraZeneca LP |
|
$ |
44 |
|
|
$ |
40 |
|
|
$ |
177 |
|
|
$ |
165 |
|
Other (1) |
|
|
11 |
|
|
|
3 |
|
|
|
16 |
|
|
|
15 |
|
|
|
|
$ |
55 |
|
|
$ |
43 |
|
|
$ |
193 |
|
|
$ |
180 |
|
|
|
|
|
(1) |
|
Primarily reflects results from Sanofi Pasteur MSD and Johnson & Johnson°Merck
Consumer Pharmaceuticals Company. |
AstraZeneca LP
In 1998, Old Merck and Astra completed the restructuring of the ownership and operations of
their existing joint venture whereby Old Merck acquired Astras interest in KBI Inc. (KBI) and
contributed KBIs operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P.
(the Partnership), in exchange for a 1% limited partner interest. Astra contributed the net
assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership in exchange for a 99%
general partner interest. The Partnership, renamed AstraZeneca LP (AZLP) upon Astras 1999 merger
with Zeneca Group Plc (the AstraZeneca merger), became the exclusive distributor of the products
for which KBI retained rights.
In connection with the 1998 restructuring, Astra purchased an option (the Asset Option) for
a payment of $443 million, which was recorded as deferred income, to buy Old Mercks interest in
the KBI products, excluding the gastrointestinal medicines Nexium and Prilosec (the Non-PPI
Products). In April 2010, AstraZeneca exercised the Asset Option. Merck received $647 million
from AstraZeneca, representing the net present value as of March 31, 2008 of projected future
pretax revenue to be received by Old Merck from the Non-PPI Products, which was recorded as a
reduction to the Companys investment in AZLP. The Company recognized the $443 million of deferred
income in the second quarter of 2010 as a component of Other (income) expense, net. In addition,
in 1998, Old Merck granted Astra an option (the Shares Option) to buy Old Mercks common stock
interest in KBI and, therefore, Old Mercks interest in Nexium and Prilosec, exercisable in 2012.
The exercise price for the Shares Option will be based on the net present value of estimated future
net sales of Nexium and Prilosec as determined at the time of exercise, subject to certain true-up
mechanisms. The Company believes that it is likely that AstraZeneca will exercise the Shares
Option.
Summarized financial information for AZLP is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Sales |
|
$ |
1,181 |
|
|
$ |
1,297 |
|
|
$ |
2,336 |
|
|
$ |
2,590 |
|
Materials and production costs |
|
|
516 |
|
|
|
626 |
|
|
|
1,061 |
|
|
|
1,259 |
|
Other expense, net |
|
|
345 |
|
|
|
313 |
|
|
|
646 |
|
|
|
455 |
|
|
Income before taxes (1) |
|
$ |
320 |
|
|
$ |
358 |
|
|
$ |
629 |
|
|
$ |
876 |
|
|
|
|
|
(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)
9. Contingencies
The Company is involved in various claims and legal proceedings of a nature considered normal
to its business, including product liability, intellectual property, and commercial litigation, as
well as additional matters such as antitrust actions.
Vioxx Litigation
Product Liability Lawsuits
As previously disclosed, individual and putative class actions have been filed against Old
Merck in state and federal courts alleging personal injury and/or economic loss with respect to the
purchase or use of Vioxx. All such actions filed in federal court are coordinated in a
multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana (the
Vioxx MDL) before District Judge Eldon E. Fallon. A number of such actions filed in state court
are coordinated in separate coordinated proceedings in state courts
in California and Texas. (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 June 30, 2011, approximately 30 plaintiff groups who were otherwise eligible for
the Settlement Program did not participate and their claims remain pending against Old Merck. In
addition, the claims of approximately 100 plaintiff groups who were not eligible for the Settlement
Program remain pending against Old Merck, a number of which are subject to various motions to
dismiss for failure to comply with court-ordered deadlines.
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 are two unresolved post-trial appeals:
Ernst v. Merck and Garza v. Merck. Merck has previously disclosed the details associated with
these cases and the grounds for Mercks appeals.
Other Lawsuits
There are still pending in various U.S. courts putative class actions purportedly brought on
behalf of individual purchasers or users of Vioxx seeking reimbursement for alleged economic loss.
In the 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.
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 has sought review before the Michigan Supreme Court, and its petition
is currently pending. These actions allege that Old Merck misrepresented the safety of Vioxx. All
but one of these suits seeks recovery for expenditures on Vioxx by government-funded health care
programs such as Medicaid, along with other relief such as penalties and attorneys fees. An
action brought by the Attorney General of Kentucky seeks only penalties for alleged Consumer Fraud
Act violations. The lawsuit brought by the county is a class action filed by Santa Clara County,
California on behalf of all similarly situated California counties. Old Merck moved to dismiss the
case brought by the Attorney General of Oklahoma in December 2010.
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
- 18 -
Notes to Consolidated Financial Statements (unaudited) (continued)
completed in April 2010 and Judge Fallon found in favor of Old Merck in June 2010
dismissing the Attorney Generals remaining claims with prejudice. The Louisiana Attorney General
filed a notice of 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.
As previously disclosed, several individual securities lawsuits filed by foreign institutional
investors also are consolidated with the Vioxx Securities Lawsuits. By stipulation, defendants are
not required to respond to these complaints until the resolution of any motions to dismiss in the
consolidated securities class action.
In addition, as previously disclosed, various putative class actions have been filed in
federal court under the Employee Retirement Income Security Act (ERISA) against Old Merck and
certain current and former officers and directors (the Vioxx ERISA Lawsuits). Those cases were
consolidated in the Shareholder MDL before Judge Chesler. Fact discovery in the Vioxx ERISA
Lawsuits closed in September 2010 and expert discovery closed on May 20, 2011. On June 20, 2011,
Old Merck filed a motion for summary judgment, and plaintiffs filed a motion for partial summary
judgment; those motions will be fully briefed on August 12, 2011. 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 June 21, 2011, plaintiffs filed a renewed motion for class certification on the count that the
court had previously ruled could not be decided on a class-wide basis; Old Merck filed an
opposition to that renewed motion on July 1, 2011, and plaintiffs filed a reply on July 14, 2011.
The motion is awaiting a decision by the court. Under the scheduling order, a final pre-trial
order is due on November 1, 2011, and a final pre-trial conference is scheduled for November 15,
2011. No trial date has been set.
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).
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
- 19 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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. The
Company cannot predict the timing of any other trials related to the Vioxx Litigation (as defined
below). The Company believes that it has meritorious defenses to the Vioxx Product Liability
Lawsuits, Vioxx Shareholder Lawsuits and Vioxx Foreign Lawsuits (collectively, the Vioxx
Lawsuits) and will vigorously defend against them. In view of the inherent difficulty of
predicting the outcome of litigation, particularly where there are many claimants and the claimants
seek indeterminate damages, the Company is unable to predict the outcome of these matters, and at
this time cannot reasonably estimate the possible loss or range of loss with respect to the Vioxx
Lawsuits not included in the Settlement Program. Unfavorable outcomes in the Vioxx Litigation
could have a material adverse effect on the Companys financial position, liquidity and results of
operations.
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 six months of 2011, the Company spent approximately $37 million in the
aggregate, including $21 million in the second 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 second quarter, the Company recorded a charge of $19 million solely for its future
legal defense costs for the Vioxx Litigation. Consequently, as of June 30, 2011, the aggregate
amount of the Vioxx Legal Defense Costs Reserve was approximately $58 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 June 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.
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 June 30, 2011, approximately 1,650
cases, which include approximately 2,050 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 1,115 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 535 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 910 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
- 20 -
Notes to Consolidated Financial Statements (unaudited) (continued)
motions in 2007 and
completing fact discovery in an initial group of 25 cases by October 1, 2008. In January 2008,
briefing and argument on plaintiffs motions for certification of medical monitoring classes were
completed in 2007 after Judge Keenan issued an order denying the motions. Also in January 2008,
Judge Keenan issued a further order dismissing with prejudice all class claims asserted in the
first four class action lawsuits filed against Old Merck that
sought personal injury damages and/or medical monitoring relief on a class wide basis.
Daubert motions were filed in May 2009 and Judge Keenan conducted a Daubert hearing in July 2009.
In July 2009, Judge Keenan issued his ruling on the parties respective Daubert motions. The
ruling denied the Plaintiff Steering Committees motion and granted in part and denied in part Old
Mercks motion. In the first Fosamax MDL trial, Boles v. Merck, the Fosamax MDL court declared a
mistrial because the eight person jury could not reach a unanimous verdict. The Boles case was
retried in June 2010 and resulted in a verdict in favor of the plaintiff in the amount of $8
million. Merck filed post-trial motions seeking judgment as a matter of law or, in the
alternative, a new trial. 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. The Company has filed a
motion for interlocutory appeal, which included Mercks motion
that the district court certify legal
issues for appeal to the U.S. Court of Appeals for the Second Circuit. On June 29, 2011, the
district court granted Mercks motion and certified one legal
question for appeal, which is now pending.
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 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 next trials scheduled in the Fosamax MDL are Secrest v. Merck, which was scheduled to
begin on March 14, 2011, but has been continued until September 7, 2011, and Hester v. Merck, which
was scheduled to begin on May 9, 2011, but after Merck filed its motion for summary judgment,
plaintiffs counsel dismissed Hester with prejudice. On April 27, 2011, Judge Keenan selected
Raber v. Merck as the case to replace Hester and set the trial for Raber to begin on November 7,
2011. In addition, Judge Keenan ordered on February 4, 2011 that there will be two further
bellwether trials conducted in the Fosamax MDL: Spano v. Merck is expected to be tried on February
27, 2012 and Jellema v. Merck is expected be tried on May 13, 2012.
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 January 9, 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 June
30, 2011, approximately 190 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.
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 is expected to be tried in March 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 June 30, 2011, approximately 430 cases alleging femur fractures and/or other bone
injuries have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic
County Superior Court. A Case
- 21 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Management Order setting forth a schedule with respect to the
review of these cases is expected but has not yet been entered and no trial dates for any of the
New Jersey state femur fracture cases has been set.
On March 23, 2011, Merck submitted a Motion to Transfer to the JPML seeking to have all
federal cases alleging femur fractures and other bone injuries consolidated into one multidistrict
litigation for coordinated pre-trial proceedings. The Motion to Transfer was granted on May 23,
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 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 Oregon.
Discovery is ongoing in the federal and state courts where femur fracture cases are pending
and the Company intends to defend against these lawsuits.
NuvaRing
Beginning in May 2007, a number of complaints were filed in various jurisdictions asserting
claims against the Companys subsidiaries Organon USA, Inc., Organon Pharmaceuticals USA, Inc.,
Organon International (collectively, Organon), and Schering-Plough arising from Organons
marketing and sale of NuvaRing, a combined hormonal contraceptive vaginal ring. The plaintiffs
contend that Organon and Schering-Plough failed to adequately warn of the alleged increased risk of
venous thromboembolism (VTE) posed by NuvaRing, and/or downplayed the risk of VTE. The plaintiffs
seek damages for injuries allegedly sustained from their product use, including some alleged
deaths, heart attacks and strokes. The majority of the cases are currently pending in a federal
multidistrict litigation (the NuvaRing MDL) venued in Missouri and in New Jersey state court.
As of June 30, 2011, there were approximately 815 NuvaRing cases. Of these cases, 690 are
pending in the NuvaRing MDL in the U.S. District Court for the Eastern District of Missouri before
Judge Rodney Sippel, and 122 are pending in consolidated discovery proceedings in the Bergen County
Superior Court of New Jersey before Judge Brian R. Martinotti. Four additional cases are pending
in various other state courts.
Pursuant to orders of Judge Sippel in the NuvaRing MDL, the parties selected 26 trial pool
cases which are the subject of fact discovery and this pool was recently narrowed to eight cases
from which the first trial cases will be selected. Pursuant to Judge Martinottis order, the
parties selected an additional 10 trial pool cases that are the subject of fact discovery in the
New Jersey consolidated proceedings. Based on a revised scheduling order entered in both
jurisdictions, fact discovery in the trial pool cases ended on June 24, 2011 and the Company
expects expert discovery to be completed by the end of February 2012. Based on the scheduling orders in
place in each jurisdiction, the Company anticipates that status conferences in each coordinated
proceeding will be held in March 2012 to determine a methodology for selecting the first cases to
be tried. The Company intends to defend against these lawsuits.
Governmental Proceedings
The DOJ has issued a subpoena requesting information related to the Companys marketing and
selling activities with respect to Temodar, PegIntron and Intron A, from January 1, 2004 to the
present, in a federal health care investigation under criminal statutes. The Company is
cooperating with the DOJs investigation.
- 22 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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.
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.
- 23 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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 on April
29, 2011. The defendants in Cain v. Hassan filed a second amended complaint on June 3, 2011. The
defendants intend to move to dismiss the second amended complaint. 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 July 7, 2011, the defendants in Rose moved to stay the case or to dismiss it without prejudice
in favor of the federal derivative action. That motion is fully briefed and a decision is pending.
Discovery in the lawsuits referred to in this section (collectively, the ENHANCE Litigation)
will be coordinated and has commenced. 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 and certain New York counties alleging manipulation by
pharmaceutical manufacturers of Average Wholesale Prices (AWP), which are sometimes used by
public and private payors in calculating provider reimbursement levels. The outcome of these
lawsuits could include substantial damages, the imposition of substantial fines and penalties and
injunctive or administrative remedies. In January 2010, the U.S. District Court for the District
of Massachusetts held that a unit of the Company and eight other drug makers overcharged New York
City and 42 New York counties for certain generic drugs. The court has reserved the issue of
damages and
- 24 -
Notes to Consolidated Financial Statements (unaudited) (continued)
any penalties for future proceedings. In a separate matter, in September 2010, a jury
in the U.S. District Court for the District of Massachusetts found the Company liable on the ground
that units of Schering-Plough caused Massachusetts to overpay pharmacists for prescriptions of
albuterol. The District Court held that
Massachusetts should be awarded approximately $13.8 million in treble damages and penalties,
together with prejudgment interest and attorneys fees, but Massachusetts has moved to amend the
judgment to include substantially higher penalties. The Company intends to pursue a reversal of the verdict on appeal.
During 2011, the Company settled certain AWP cases brought by the states of Utah, South
Carolina, Alaska, Idaho, Kentucky, Pennsylvania, Mississippi, and Wisconsin. The Company and/or certain of its subsidiaries
continue to be defendants in cases brought by 13 states and the New York counties.
Centocor Distribution Agreement
In May 2009, Centocor, a wholly owned subsidiary of Johnson & Johnson, delivered to
Schering-Plough a notice initiating an arbitration proceeding to resolve whether, as a result of
the Merger, Centocor was permitted to terminate the Companys rights to distribute and
commercialize Remicade and Simponi. On April 15, 2011, the Company announced that it had settled
the arbitration. Under the terms of the amended distribution agreement, Mercks subsidiary,
Schering-Plough (Ireland), relinquished exclusive marketing rights for Remicade and Simponi to
Johnson & Johnsons Janssen pharmaceutical companies in territories including Canada, Central and
South America, the Middle East, Africa and Asia Pacific (Relinquished Territories), effective
July 1, 2011. Merck retained exclusive marketing rights throughout Europe, Russia and Turkey
(Retained Territories). The Retained Territories represent approximately 70% of Mercks 2010
revenue of $2.8 billion from Remicade and Simponi, while the Relinquished Territories
represent approximately 30%. In addition, all profit derived from Mercks exclusive distribution
of the two products in the Retained Territories will be equally divided between Merck and Johnson &
Johnson, beginning July 1, 2011. Under the prior terms of the distribution agreement, the
contribution income (profit) split, which was at 58% to Merck and 42% to Centocor Ortho
Biotech Inc., would have declined for Merck and increased for Johnson & Johnson each year until
2014, when it would have been equally divided. Johnson & Johnson also received a one-time payment
from Merck of $500 million in April 2011.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file Abbreviated New Drug
Applications (ANDAs) with the FDA seeking to market generic forms of the Companys products prior
to the expiration of relevant patents owned by the Company. To protect its patent rights the
Company may file patent infringement lawsuits against such generic companies. Certain products of
the Company (or marketed via agreements with other companies) currently involved in such patent
infringement litigation in the United States include: 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. (Millennium)) in the United States against TPM in respect of
TPMs application to the FDA seeking approval to sell a generic version of Integrilin prior to the
expiry of the last to expire listed patent. As TPM
- 25 -
Notes to Consolidated Financial Statements (unaudited) (continued)
did not challenge certain patents that will not
expire until November 2014, FDA approval of the TPM application cannot occur any earlier than
November 2014, however, it could be later in the event of a favorable decision in the lawsuit for
the Company and Millennium.
Nasonex In December 2009, a patent infringement suit was filed in the United States against
Apotex Corp. (Apotex) in respect of Apotexs application to the FDA seeking pre-patent expiry
approval to market a generic version of Nasonex. The lawsuit automatically stays FDA approval of
Apotexs ANDA until May 2012 or until an adverse court decision, if any, whichever may occur
earlier.
Nexium In November 2005, a patent infringement lawsuit was filed (jointly with AstraZeneca)
in the United States against Ranbaxy Laboratories Ltd. (Ranbaxy) in respect of Ranbaxys
application to the FDA seeking pre-patent expiry approval to sell a generic version of Nexium. As
previously disclosed, AstraZeneca, Merck and Ranbaxy entered into a settlement agreement which
provided that Ranbaxy would be entitled to bring its generic esomeprazole product to market in the
United States on May 27, 2014. The Company and AstraZeneca each received a Civil Investigative
Demand (CID) from the Federal Trade Commission (FTC) in July 2008 regarding the settlement
agreement with Ranbaxy. The Company is cooperating with the FTC in responding to this CID. In
March 2006, a patent infringement lawsuit was filed (jointly with AstraZeneca) against IVAX
Pharmaceuticals, Inc. (IVAX) (later acquired by Teva Pharmaceuticals, Inc. (Teva)), in respect
of IVAXs application to the FDA seeking pre-patent expiry approval to sell a generic version of
Nexium. In January 2010, AstraZeneca, Merck and Teva/IVAX entered into a settlement agreement
which provides that Teva/IVAX would be entitled to bring its generic esomeprazole product to market
in the United States on May 27, 2014. Patent infringement lawsuits have also been filed in the
United States against Dr. Reddys Laboratories (Dr. Reddys), Sandoz and Lupin Ltd. (Lupin) in
respect to their respective applications to the FDA seeking pre-patent expiry approval to sell
generic versions of Nexium. In January 2011, AstraZeneca, Merck and Dr. Reddys entered into a
settlement agreement which provides that Dr. Reddys would be entitled to bring its generic
esomeprazole product to market in the United States on May 27, 2014. In June 2011, AstraZeneca,
Merck and Sandoz entered into a settlement agreement which provides that Sandoz would 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 in respect of its
application to the FDA seeking pre-patent expiry approval to sell a generic version of Nexium IV.
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. By virtue of an
agreement that Barr not launch a product during the appeal process, the Company has agreed that
Barr can launch a product in August 2013.
In September 2010, a patent infringement lawsuit was filed (jointly with CRT) in the United
States against Sun Pharmaceutical Industries Inc. (Sun) in respect of Suns application to the
FDA seeking pre-patent expiry approval to sell a generic version of Temodar. The lawsuit
automatically stays FDA approval of Suns ANDA until February 2013 or until an adverse court
decision, if any, whichever may occur earlier. In November 2010, a patent infringement lawsuit was
filed (jointly with CRT) in the United States against Accord HealthCare Inc. (Accord) in respect
of its application to the FDA seeking pre-patent expiry approval to sell a generic version of
Temodar. The Company, CRT and Accord have entered an agreement to stay the lawsuit pending the
outcome of the appeal en banc process in the Barr lawsuit.
- 26 -
Notes to Consolidated Financial Statements (unaudited) (continued)
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.
Zetia In March 2007, a patent infringement lawsuit was filed in the United States against
Glenmark Pharmaceuticals Inc., USA and its parent corporation (collectively, Glenmark) in respect
of Glenmarks application to the FDA seeking pre-patent expiry approval to sell a generic version
of Zetia. In May 2010, Glenmark agreed to a settlement by virtue of which Glenmark will be
permitted to launch its generic product in the United States on December 12, 2016, subject to
receiving final FDA approval. In June 2010, a patent infringement lawsuit was filed in the United
States against Mylan in respect of Mylans application to the FDA seeking pre-patent expiry
approval to sell a generic version of Zetia. The lawsuit automatically stays FDA approval of
Mylans application until December 2012 or until an adverse court decision, if any, whichever may
occur earlier. 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 scheduled to begin on October 3, 2011.
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 include Old Merck and three of the other original 12 defendants. On March 31,
2011, the Phase 1 jury returned a mixed verdict, finding in favor of Old Merck and the other
defendants as to some, but not all, of plaintiffs claims. Specifically, the jury found that
contamination from the site did not enter or affect plaintiffs municipal water supply wells or any
private domestic wells. The jury found, however, that plaintiffs could have been exposed to
contamination via air emissions prior to 1994, as well as via surface water in the form of storm
drainage channeled into an adjacent irrigation canal, including during a flood in April 2006. Old
Merck has filed motions requesting that the court set aside those portions of the jurys verdict
that are adverse to Old Merck on the basis that those portions of the verdict are unsupported by
the evidence and contrary to established legal principles. If necessary, Old Merck will seek to
appeal, prior to commencement of any later phases of the litigation, those portions of the jurys
verdict adverse to Old Merck that are not set aside by the trial court. In the event the Phase 1
jurys findings in favor of plaintiffs are not set aside by the trial court or on appeal, it is
anticipated that later phases of the litigation would be required to address issues related to
liability, causation and damages related to specific plaintiffs.
In the second quarter of 2011, the DOJ and the U.S. Environmental Protection Agency (the EPA)
notified the Company that they are 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. The Company believes
that it has meritorious defenses to these allegations.
The EPA and Merck have entered into a consent decree under which Merck paid a $260,000 fine to
resolve alleged environmental violations at Mercks Las Piedras Puerto Rico facility. The alleged
violations arose from an EPA air inspection conducted in July 2008 and were primarily based on the
sites leak detection and repair program.
Other Litigation
There are various other legal proceedings, principally product liability and intellectual
property suits, involving the Company that are pending. While it is not feasible to predict the
outcome of such proceedings or
- 27 -
Notes to Consolidated Financial Statements (unaudited) (continued)
the proceedings discussed in this Note for which a separate
assessment is not provided, in the opinion of the Company, the amount or range of reasonably possible loss associated with the
resolution of such proceedings,
either individually or in the aggregate, is not material.
10. Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Non- |
|
|
|
|
|
|
Common Stock |
|
|
Paid-In |
|
|
Retained |
|
|
Comprehensive |
|
|
Treasury Stock |
|
|
Controlling |
|
|
|
|
($ in millions) |
|
Shares |
|
|
Par Value |
|
|
Capital |
|
|
Earnings |
|
|
Loss |
|
|
Shares |
|
|
Cost |
|
|
Interests |
|
|
Total |
|
|
Balance January 1, 2010 |
|
|
3,563 |
|
|
$ |
1,781 |
|
|
$ |
39,683 |
|
|
$ |
41,405 |
|
|
$ |
(2,767 |
) |
|
|
454 |
|
|
$ |
(21,044 |
) |
|
$ |
2,427 |
|
|
$ |
61,485 |
|
Net income attributable to
Merck & Co., Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,051 |
|
Cash dividends declared on
common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,374 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,374 |
) |
Treasury stock shares purchased |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38 |
|
|
|
(1,297 |
) |
|
|
|
|
|
|
(1,297 |
) |
Share-based compensation
plans and other |
|
|
10 |
|
|
|
5 |
|
|
|
655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25 |
|
|
|
|
|
|
|
685 |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,892 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,892 |
) |
Net income attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59 |
|
|
|
59 |
|
Distributions attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(60 |
) |
|
|
(60 |
) |
|
Balance June 30, 2010 |
|
|
3,573 |
|
|
$ |
1,786 |
|
|
$ |
40,338 |
|
|
$ |
40,082 |
|
|
$ |
(4,659 |
) |
|
|
492 |
|
|
$ |
(22,316 |
) |
|
$ |
2,426 |
|
|
$ |
57,657 |
|
|
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. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,067 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,067 |
|
Cash dividends declared on
common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,360 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,360 |
) |
Treasury stock shares purchased |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9 |
|
|
|
(314 |
) |
|
|
|
|
|
|
(314 |
) |
Share-based compensation
plans and other |
|
|
|
|
|
|
|
|
|
|
(44 |
) |
|
|
|
|
|
|
|
|
|
|
(10 |
) |
|
|
331 |
|
|
|
|
|
|
|
287 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
440 |
|
Net income attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58 |
|
|
|
58 |
|
Distributions attributable to
noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(61 |
) |
|
|
(61 |
) |
|
Balance June 30, 2011 |
|
|
3,577 |
|
|
$ |
1,788 |
|
|
$ |
40,657 |
|
|
$ |
38,243 |
|
|
$ |
(2,776 |
) |
|
|
494 |
|
|
$ |
(22,416 |
) |
|
$ |
2,426 |
|
|
$ |
57,922 |
|
|
In connection with the 1998 restructuring of Astra Merck Inc., the Company assumed $2.4
billion par value preferred stock with a dividend rate of 5% per annum, which is carried by KBI and
included in Noncontrolling interests on the Consolidated Balance Sheet. If AstraZeneca exercises
the Shares Option (see Note 8), this preferred stock obligation will be settled.
The accumulated balances related to each component of other comprehensive income (loss), net
of taxes, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
|
Cumulative |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
Benefit |
|
|
Translation |
|
|
Comprehensive |
|
($ in millions) |
|
Derivatives |
|
|
Investments |
|
|
Plans |
|
|
Adjustment |
|
|
Income (Loss) |
|
|
Balance January 1, 2010 |
|
$ |
(42 |
) |
|
$ |
33 |
|
|
$ |
(2,469 |
) |
|
$ |
(289 |
) |
|
$ |
(2,767 |
) |
Other comprehensive income (loss) |
|
|
179 |
|
|
|
(4 |
) |
|
|
121 |
|
|
|
(2,188 |
) |
|
|
(1,892 |
) |
|
Balance at June 30, 2010 |
|
$ |
137 |
|
|
$ |
29 |
|
|
$ |
(2,348 |
) |
|
$ |
(2,477 |
) |
|
$ |
(4,659 |
) |
|
Balance January 1, 2011 |
|
$ |
41 |
|
|
$ |
31 |
|
|
$ |
(2,043 |
) |
|
$ |
(1,245 |
) |
|
$ |
(3,216 |
) |
Other comprehensive income (loss) |
|
|
(137 |
) |
|
|
(5 |
) |
|
|
28 |
|
|
|
554 |
|
|
|
440 |
|
|
Balance at June 30, 2011 |
|
$ |
(96 |
) |
|
$ |
26 |
|
|
$ |
(2,015 |
) |
|
$ |
(691 |
) |
|
$ |
(2,776 |
) |
|
- 28 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Comprehensive income (loss) was $2.4 billion and $(335) million for the three months ended
June 30, 2011 and 2010, respectively, and was $3.5 billion and $(841) million for the six months
ended June 30, 2011 and 2010, respectively.
Included
in the cumulative translation adjustment are pretax (losses) gains of $(178) million
and $462 million for the first six 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 $340 million and $(2.1) billion for the first six months of 2011 and 2010,
respectively, relating to the translation impacts of intangible assets recorded in conjunction with
the Merger.
11. Share-Based Compensation Plans
The Company has share-based compensation plans under which employees and non-employee
directors may be granted restricted stock units (RSUs). In addition, the Company grants options
to purchase shares of Company common stock at the fair market value at the time of grant and
performance share units (PSUs) to certain management-level employees. The Company recognizes the
fair value of share-based compensation in net income on a straight-line basis over the requisite
service period.
The following table provides amounts of share-based compensation cost recorded in the
Consolidated Statement of Income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pretax share-based compensation expense |
|
$ |
107 |
|
|
$ |
142 |
|
|
$ |
200 |
|
|
$ |
274 |
|
Income tax benefit |
|
|
(37 |
) |
|
|
(49 |
) |
|
|
(69 |
) |
|
|
(93 |
) |
|
Total share-based compensation expense, net of taxes |
|
$ |
70 |
|
|
$ |
93 |
|
|
$ |
131 |
|
|
$ |
181 |
|
|
During the first six months of 2011 and 2010, the Company granted 8 million RSUs with a
weighted-average grant date fair value of $36.47 per RSU and 10 million RSUs with a
weighted-average grant date fair value of $33.89 per RSU, respectively.
During the first six 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 $34.25 per option, respectively.
The weighted average fair value of options
granted for the first six months of 2011 and 2010 was $5.37 and $8.02 per option, respectively, and
was determined using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
Expected dividend yield |
|
|
4.3 |
% |
|
|
4.1 |
% |
Risk-free interest rate |
|
|
2.6 |
% |
|
|
2.8 |
% |
Expected volatility |
|
|
23.2 |
% |
|
|
33.8 |
% |
Expected life (years) |
|
|
7.0 |
|
|
|
6.8 |
|
|
At
June 30, 2011, there was $565 million of total pretax unrecognized compensation expense
related to nonvested stock options, RSU and PSU awards which will be recognized over a weighted
average period of 2.1 years. For segment reporting, share-based compensation costs are unallocated
expenses.
- 29 -
Notes to Consolidated Financial Statements (unaudited) (continued)
12. Pension and Other Postretirement Benefit Plans
The Company has defined benefit pension plans covering eligible employees in the United States
and in certain of its international subsidiaries. The net cost of such plans consisted of the
following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Service cost |
|
$ |
151 |
|
|
$ |
147 |
|
|
$ |
303 |
|
|
$ |
301 |
|
Interest cost |
|
|
180 |
|
|
|
172 |
|
|
|
359 |
|
|
|
349 |
|
Expected return on plan assets |
|
|
(242 |
) |
|
|
(215 |
) |
|
|
(485 |
) |
|
|
(432 |
) |
Net amortization |
|
|
46 |
|
|
|
43 |
|
|
|
91 |
|
|
|
88 |
|
Termination benefits |
|
|
7 |
|
|
|
9 |
|
|
|
17 |
|
|
|
28 |
|
Curtailments |
|
|
(6 |
) |
|
|
(1 |
) |
|
|
(10 |
) |
|
|
(37 |
) |
Settlements |
|
|
|
|
|
|
(6 |
) |
|
|
(1 |
) |
|
|
(7 |
) |
|
|
|
$ |
136 |
|
|
$ |
149 |
|
|
$ |
274 |
|
|
$ |
290 |
|
|
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 |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Service cost |
|
$ |
28 |
|
|
$ |
28 |
|
|
$ |
56 |
|
|
$ |
54 |
|
Interest cost |
|
|
35 |
|
|
|
36 |
|
|
|
71 |
|
|
|
74 |
|
Expected return on plan assets |
|
|
(36 |
) |
|
|
(33 |
) |
|
|
(71 |
) |
|
|
(65 |
) |
Net amortization |
|
|
(6 |
) |
|
|
2 |
|
|
|
(9 |
) |
|
|
4 |
|
Termination benefits |
|
|
4 |
|
|
|
7 |
|
|
|
6 |
|
|
|
27 |
|
Curtailments |
|
|
|
|
|
|
(2 |
) |
|
|
1 |
|
|
|
(2 |
) |
|
|
|
$ |
25 |
|
|
$ |
38 |
|
|
$ |
54 |
|
|
$ |
92 |
|
|
In connection with restructuring actions (see Note 2), termination charges for the three and
six months ended June 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.
13. Other (Income) Expense, Net
Other (income) expense, net, consisted of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Interest income |
|
$ |
(51 |
) |
|
$ |
(22 |
) |
|
$ |
(92 |
) |
|
$ |
(34 |
) |
Interest expense |
|
|
182 |
|
|
|
185 |
|
|
|
368 |
|
|
|
366 |
|
Exchange losses |
|
|
1 |
|
|
|
(4 |
) |
|
|
43 |
|
|
|
76 |
|
Other, net |
|
|
(11 |
) |
|
|
(440 |
) |
|
|
425 |
|
|
|
(521 |
) |
|
|
|
$ |
121 |
|
|
$ |
(281 |
) |
|
$ |
744 |
|
|
$ |
(113 |
) |
|
Other, net (as presented in the table above) for the first six 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 9 to the interim consolidated financial
statements), as well as a $127 million gain on the sale of certain manufacturing facilities and
related assets. Other, net for the second quarter and first six months of 2010 reflects $443
million of income recognized upon AstraZenecas asset option exercise. Other, net for the first
six months of 2010 also reflects $102 million of income recognized on the settlement of certain
disputed royalties.
- 30 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Exchange losses for the first six months of 2011 declined as compared with the first six months of
2010 primarily driven by a Venezuelan currency devaluation in the first quarter of 2010 resulting
in the recognition of $80 million of exchange losses. Effective January 11, 2010, the Venezuelan
government devalued its currency from at BsF 2.15 per U.S. dollar to a two-tiered official exchange
rate at (1) the essentials rate at BsF 2.60 per U.S. dollar and (2) the non-essentials rate at
BsF 4.30 per U.S. dollar. In January 2010, the Company was required to remeasure its local
currency operations in Venezuela to U.S. dollars as the Venezuelan economy was determined to be
hyperinflationary. Throughout 2010, the Company settled its transactions at the essentials rate
and therefore remeasured monetary assets and liabilities using the essentials rate. In December
2010, the Venezuelan government announced it would eliminate the
essentials rate and, effective
January 1, 2011, all transactions would be settled at the official rate of at BsF 4.30 per U.S.
dollar. As a result of this announcement, the Company remeasured its December 31, 2010 monetary
assets and liabilities at the new official rate. Interest paid for the six months ended June 30,
2011 and 2010 was $194 million and $312 million, respectively, which excludes commitment fees. Interest
paid for the six months ended June 30, 2011 is net of $175 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 (22.8%) for the
second quarter of 2011 and 8.1% for the first six
months of 2011 reflect a net favorable impact relating to the
settlement of Old Mercks 2002-2005 federal income tax audit as
discussed below, as
well as 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. The tax rates also
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 six
months of 2011 reflects the impacts of the $500 million charge related to the resolution of the
arbitration proceeding with Johnson & Johnson. The effective tax rates of 37.1% for the second
quarter of 2010 and 40.2% for the first six months of 2010, as compared with the statutory rate of
35%, reflect the unfavorable impact of purchase accounting charges, AstraZenecas asset option
exercise and restructuring charges, largely offset by the beneficial impact of foreign earnings.
In addition, the effective tax rate for the first six 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.
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 any risks or exposures.
In April 2011, the IRS concluded its examination of Old Mercks 2002-2005 federal income tax
returns and as a result the Company was required to make net payments of approximately $465
million. The Companys unrecognized tax benefits for the years under examination 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
- 31 -
Notes to Consolidated Financial Statements (unaudited) (continued)
approximately $340 million (U.S. dollars) plus approximately $375 million (U.S. dollars) of
interest through June 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 Company is petitioning the court for a rehearing.
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.
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 |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Basic Earnings per Common Share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income attributable to Merck & Co., Inc.
common shareholders |
|
$ |
2,024 |
|
|
$ |
752 |
|
|
$ |
3,067 |
|
|
$ |
1,051 |
|
Less: Income allocated to participating securities |
|
|
4 |
|
|
|
3 |
|
|
|
8 |
|
|
|
4 |
|
|
Net income allocated to common shareholders |
|
$ |
2,020 |
|
|
$ |
749 |
|
|
$ |
3,059 |
|
|
$ |
1,047 |
|
|
Average common shares outstanding |
|
|
3,086 |
|
|
|
3,105 |
|
|
|
3,085 |
|
|
|
3,109 |
|
|
|
|
$ |
0.65 |
|
|
$ |
0.24 |
|
|
$ |
0.99 |
|
|
$ |
0.34 |
|
|
Earnings per Common Share Assuming Dilution |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income attributable to Merck & Co., Inc.
common shareholders |
|
$ |
2,024 |
|
|
$ |
752 |
|
|
$ |
3,067 |
|
|
$ |
1,051 |
|
Less: Income allocated to participating securities |
|
|
4 |
|
|
|
3 |
|
|
|
8 |
|
|
|
4 |
|
|
Net income allocated to common shareholders |
|
$ |
2,020 |
|
|
$ |
749 |
|
|
$ |
3,059 |
|
|
$ |
1,047 |
|
|
Average common shares outstanding |
|
|
3,086 |
|
|
|
3,105 |
|
|
|
3,085 |
|
|
|
3,109 |
|
Common shares issuable (1) |
|
|
24 |
|
|
|
20 |
|
|
|
21 |
|
|
|
23 |
|
|
Average common shares outstanding assuming dilution |
|
|
3,110 |
|
|
|
3,125 |
|
|
|
3,106 |
|
|
|
3,132 |
|
|
|
|
$ |
0.65 |
|
|
$ |
0.24 |
|
|
$ |
0.98 |
|
|
$ |
0.33 |
|
|
|
|
|
(1) |
|
Issuable primarily under share-based compensation plans. |
For the three months ended June 30, 2011 and 2010, 138 million and 195 million,
respectively, and for the six months ended 2011 and 2010, 173 million and 179 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.
- 32 -
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 |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Segment revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
10,360 |
|
|
$ |
9,638 |
|
|
$ |
20,179 |
|
|
$ |
19,303 |
|
All other segment revenues |
|
|
1,665 |
|
|
|
1,525 |
|
|
|
3,275 |
|
|
|
3,095 |
|
|
|
|
$ |
12,025 |
|
|
$ |
11,163 |
|
|
$ |
23,454 |
|
|
$ |
22,398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment profits: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical segment |
|
$ |
6,443 |
|
|
$ |
5,987 |
|
|
$ |
12,659 |
|
|
$ |
11,727 |
|
All other segment profits |
|
|
655 |
|
|
|
627 |
|
|
|
1,371 |
|
|
|
1,347 |
|
|
|
|
$ |
7,098 |
|
|
$ |
6,614 |
|
|
$ |
14,030 |
|
|
$ |
13,074 |
|
|
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.
- 33 -
Notes to Consolidated Financial Statements (unaudited) (continued)
Sales of the Companys products were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Zetia |
|
$ |
592 |
|
|
$ |
564 |
|
|
$ |
1,174 |
|
|
$ |
1,098 |
|
Vytorin |
|
|
459 |
|
|
|
490 |
|
|
|
939 |
|
|
|
967 |
|
Integrilin |
|
|
56 |
|
|
|
70 |
|
|
|
120 |
|
|
|
140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes and Obesity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Januvia |
|
|
779 |
|
|
|
600 |
|
|
|
1,518 |
|
|
|
1,111 |
|
Janumet |
|
|
321 |
|
|
|
218 |
|
|
|
626 |
|
|
|
419 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diversified Brands |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cozaar/Hyzaar |
|
|
406 |
|
|
|
485 |
|
|
|
832 |
|
|
|
1,267 |
|
Zocor |
|
|
107 |
|
|
|
117 |
|
|
|
234 |
|
|
|
233 |
|
Propecia |
|
|
112 |
|
|
|
113 |
|
|
|
218 |
|
|
|
213 |
|
Claritin Rx |
|
|
65 |
|
|
|
58 |
|
|
|
186 |
|
|
|
157 |
|
Remeron |
|
|
57 |
|
|
|
59 |
|
|
|
117 |
|
|
|
110 |
|
Vasotec/Vaseretic |
|
|
59 |
|
|
|
63 |
|
|
|
116 |
|
|
|
122 |
|
Proscar |
|
|
53 |
|
|
|
56 |
|
|
|
113 |
|
|
|
114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious Disease |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Isentress |
|
|
337 |
|
|
|
267 |
|
|
|
629 |
|
|
|
499 |
|
Cancidas |
|
|
168 |
|
|
|
150 |
|
|
|
326 |
|
|
|
303 |
|
PegIntron |
|
|
154 |
|
|
|
185 |
|
|
|
319 |
|
|
|
371 |
|
Primaxin |
|
|
136 |
|
|
|
158 |
|
|
|
272 |
|
|
|
317 |
|
Invanz |
|
|
103 |
|
|
|
83 |
|
|
|
189 |
|
|
|
158 |
|
Avelox |
|
|
61 |
|
|
|
59 |
|
|
|
167 |
|
|
|
165 |
|
Noxafil |
|
|
56 |
|
|
|
50 |
|
|
|
110 |
|
|
|
99 |
|
Rebetol |
|
|
48 |
|
|
|
55 |
|
|
|
100 |
|
|
|
111 |
|
Crixivan/Stocrin |
|
|
50 |
|
|
|
48 |
|
|
|
95 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neurosciences and Ophthalmology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maxalt |
|
|
131 |
|
|
|
133 |
|
|
|
304 |
|
|
|
268 |
|
Cosopt/Trusopt |
|
|
122 |
|
|
|
123 |
|
|
|
236 |
|
|
|
238 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Temodar |
|
|
234 |
|
|
|
271 |
|
|
|
481 |
|
|
|
545 |
|
Emend |
|
|
120 |
|
|
|
93 |
|
|
|
207 |
|
|
|
177 |
|
Intron A |
|
|
47 |
|
|
|
51 |
|
|
|
96 |
|
|
|
105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Respiratory and Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Singulair |
|
|
1,354 |
|
|
|
1,258 |
|
|
|
2,682 |
|
|
|
2,423 |
|
Remicade |
|
|
842 |
|
|
|
669 |
|
|
|
1,595 |
|
|
|
1,343 |
|
Nasonex |
|
|
323 |
|
|
|
338 |
|
|
|
696 |
|
|
|
658 |
|
Clarinex |
|
|
209 |
|
|
|
191 |
|
|
|
364 |
|
|
|
355 |
|
Arcoxia |
|
|
100 |
|
|
|
95 |
|
|
|
214 |
|
|
|
190 |
|
Simponi |
|
|
75 |
|
|
|
18 |
|
|
|
129 |
|
|
|
28 |
|
Asmanex |
|
|
47 |
|
|
|
56 |
|
|
|
107 |
|
|
|
107 |
|
Proventil |
|
|
37 |
|
|
|
55 |
|
|
|
80 |
|
|
|
112 |
|
Dulera |
|
|
25 |
|
|
|
|
|
|
|
37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaccines (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ProQuad/M-M-R II/Varivax |
|
|
291 |
|
|
|
340 |
|
|
|
535 |
|
|
|
659 |
|
Gardasil |
|
|
277 |
|
|
|
219 |
|
|
|
490 |
|
|
|
451 |
|
RotaTeq |
|
|
148 |
|
|
|
139 |
|
|
|
272 |
|
|
|
231 |
|
Zostavax |
|
|
122 |
|
|
|
18 |
|
|
|
146 |
|
|
|
114 |
|
Pneumovax |
|
|
64 |
|
|
|
59 |
|
|
|
143 |
|
|
|
110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Womens Health and Endocrine |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fosamax |
|
|
221 |
|
|
|
241 |
|
|
|
429 |
|
|
|
472 |
|
NuvaRing |
|
|
154 |
|
|
|
145 |
|
|
|
297 |
|
|
|
280 |
|
Follistim AQ |
|
|
143 |
|
|
|
137 |
|
|
|
276 |
|
|
|
270 |
|
Implanon |
|
|
81 |
|
|
|
51 |
|
|
|
141 |
|
|
|
101 |
|
Cerazette |
|
|
66 |
|
|
|
49 |
|
|
|
125 |
|
|
|
104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other pharmaceutical (2) |
|
|
948 |
|
|
|
941 |
|
|
|
1,697 |
|
|
|
1,888 |
|
|
Total Pharmaceutical segment sales |
|
|
10,360 |
|
|
|
9,638 |
|
|
|
20,179 |
|
|
|
19,303 |
|
|
Other segment sales (3) |
|
|
1,665 |
|
|
|
1,525 |
|
|
|
3,275 |
|
|
|
3,095 |
|
|
Total segment sales |
|
|
12,025 |
|
|
|
11,163 |
|
|
|
23,454 |
|
|
|
22,398 |
|
|
Other (4) |
|
|
126 |
|
|
|
183 |
|
|
|
278 |
|
|
|
370 |
|
|
|
|
$ |
12,151 |
|
|
$ |
11,346 |
|
|
$ |
23,732 |
|
|
$ |
22,768 |
|
|
|
|
|
(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 $306 million and $241 million for the second
quarter of 2011 and 2010, respectively, and $628 million and $605 million for the first six
months of 2011 and 2010, respectively. |
|
(4) |
|
Other revenues are primarily comprised of miscellaneous corporate revenues,
third-party manufacturing sales, sales related to divested products or businesses and other
supply sales not included in segment results. |
- 34 -
Notes to Consolidated Financial Statements (unaudited) (continued)
A reconciliation of segment profits to Income before taxes is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Segment profits |
|
$ |
7,098 |
|
|
$ |
6,614 |
|
|
$ |
14,030 |
|
|
$ |
13,074 |
|
Other profits |
|
|
58 |
|
|
|
50 |
|
|
|
35 |
|
|
|
62 |
|
Adjustments |
|
|
257 |
|
|
|
125 |
|
|
|
476 |
|
|
|
249 |
|
Unallocated: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
51 |
|
|
|
22 |
|
|
|
92 |
|
|
|
34 |
|
Interest expense |
|
|
(182 |
) |
|
|
(185 |
) |
|
|
(368 |
) |
|
|
(366 |
) |
Equity income from affiliates |
|
|
(39 |
) |
|
|
(47 |
) |
|
|
15 |
|
|
|
|
|
Depreciation and amortization |
|
|
(623 |
) |
|
|
(786 |
) |
|
|
(1,194 |
) |
|
|
(1,286 |
) |
Research and development |
|
|
(1,936 |
) |
|
|
(2,179 |
) |
|
|
(4,094 |
) |
|
|
(4,230 |
) |
Amortization of purchase
accounting adjustments |
|
|
(1,363 |
) |
|
|
(1,662 |
) |
|
|
(2,943 |
) |
|
|
(4,036 |
) |
Restructuring costs |
|
|
(668 |
) |
|
|
(526 |
) |
|
|
(654 |
) |
|
|
(814 |
) |
Arbitration settlement charge |
|
|
|
|
|
|
|
|
|
|
(500 |
) |
|
|
|
|
Gain on AstraZeneca option exercise |
|
|
|
|
|
|
443 |
|
|
|
|
|
|
|
443 |
|
Other expenses, net |
|
|
(981 |
) |
|
|
(628 |
) |
|
|
(1,494 |
) |
|
|
(1,274 |
) |
|
|
|
$ |
1,672 |
|
|
$ |
1,241 |
|
|
$ |
3,401 |
|
|
$ |
1,856 |
|
|
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.
- 35 -
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Merger
On November 3, 2009, Merck & Co., Inc. (Old Merck) and Schering-Plough Corporation
(Schering-Plough) completed their previously-announced merger (the Merger). In the Merger,
Schering-Plough acquired all of the shares of Old Merck, which became a wholly owned subsidiary of
Schering-Plough and was renamed Merck Sharp & Dohme Corp. Schering-Plough continued as the
surviving public company and was renamed Merck & Co., Inc. (New Merck or the Company).
However, for accounting purposes only, the Merger was treated as an acquisition with Old Merck
considered the accounting acquirer. References in this report and in the accompanying financial
statements to Merck for periods prior to the Merger refer to Old Merck and for periods after the
completion of the Merger to New Merck.
Arbitration Settlement
In April 2011, Merck and Johnson & Johnson reached agreement to amend the distribution rights
to Remicade and Simponi. This agreement concluded the arbitration proceeding Johnson & Johnson
initiated in May 2009, requesting a ruling related to the distribution agreement following the
announcement of the proposed merger between Merck and Schering-Plough. Under the terms of the
amended distribution agreement, Merck relinquished exclusive marketing rights for Remicade and
Simponi to Johnson & Johnson in territories including Canada, Central and South America, the Middle
East, Africa and Asia Pacific effective July 1, 2011. Merck retained exclusive marketing rights
throughout Europe, Russia and Turkey (Retained Territories). The Retained Territories represent
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 Johnson &
Johnson. Under the prior terms of the distribution agreement, the contribution income (profit)
split, which was at 58% to Merck and 42% percent to Johnson & Johnson, would have declined for
Merck and increased for Johnson & Johnson each year until 2014, when it would have been equally
divided. Johnson & Johnson also received a one-time payment from Merck of $500 million in April
2011.
U.S. Health Care Reform Legislation
In 2010, the United States enacted major health care reform legislation. Various insurance
market reforms began last year and will continue through full implementation in 2014. The new law
is expected to expand access to health care to more than 32 million Americans by the end of the
decade that did not previously have regular access to health care.
With respect to the effect of the law on the pharmaceutical industry, beginning in 2010, the
law increased the mandated Medicaid rebate from 15.1% to 23.1%, expanded the rebate to Medicaid
managed care utilization, and increased the types of entities eligible for the federal 340B drug
discount program. The implementation of these provisions reduced revenues by approximately $45
million and $44 million in the second quarter of 2011 and 2010, respectively, and by $85 million
and $76 million for the first six 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 $36 million and $70 million was recorded as a
reduction to revenue in the second quarter and first six months of 2011, respectively, related to
the estimated impact of this provision of health care reform.
Also, beginning in 2011, pharmaceutical manufacturers will be required to pay an annual health
care reform fee. The total annual industry fee, which will be $2.5 billion in 2011, will be
assessed on each company in proportion to its share of sales to certain government programs, such
as Medicare and Medicaid. The Companys portion of the annual fee is payable no later than
September 30 of the applicable calendar year and is not tax deductible. The liability related to
the annual fee for 2011 was estimated by the Company to be $167 million and was recorded in full
during the first quarter of 2011 with a corresponding offset to a deferred asset. The deferred
asset is being amortized to Marketing and administrative expense during 2011 on a straight-line
basis, therefore $43 million and $85 million of expense was recognized in the second quarter and
first six months of 2011, respectively.
- 36 -
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.
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 $12.2 billion for the second quarter of 2011, an increase of 7% compared
with the second quarter of 2010. Foreign exchange favorably affected global sales performance by
4% for the second quarter of 2011. The revenue increase largely reflects higher sales of Januvia
and Janumet, Remicade, Zostavax, Singulair and Isentress. In addition, sales performance reflects
higher revenue from the Companys relationship with AstraZeneca LP (AZLP), as well as increased
sales of the Companys animal health products. Also contributing to sales growth in the quarter
were Gardasil and Simponi. These increases were partially offset by lower sales of Cozaar and
Hyzaar which lost patent protection in the United States in April 2010 and in a number of major
European markets in March 2010. Revenue was also negatively affected by lower sales of
Caelyx and Subutex/Suboxone for which the Company no longer has marketing rights, and
lower sales of ProQuad.
Worldwide sales were $23.7 billion for the first six months of 2011, an increase of 4%
compared with the same period in 2010. Foreign exchange favorably affected global sales
performance by 2% for the first six months of 2011. The revenue increase largely reflect higher
sales of Januvia and Janumet, Singulair,
Remicade, Isentress and Simponi, as well as increased sales
of the Companys animal health products. These increases were partially offset by lower sales of
Cozaar and Hyzaar, Caelyx, Subutex/Suboxone and Varivax.
- 37 -
Sales of the Companys products were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pharmaceutical: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Zetia |
|
$ |
592 |
|
|
$ |
564 |
|
|
$ |
1,174 |
|
|
$ |
1,098 |
|
Vytorin |
|
|
459 |
|
|
|
490 |
|
|
|
939 |
|
|
|
967 |
|
Integrilin |
|
|
56 |
|
|
|
70 |
|
|
|
120 |
|
|
|
140 |
|
Diabetes and Obesity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Januvia |
|
|
779 |
|
|
|
600 |
|
|
|
1,518 |
|
|
|
1,111 |
|
Janumet |
|
|
321 |
|
|
|
218 |
|
|
|
626 |
|
|
|
419 |
|
Diversified Brands |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cozaar/Hyzaar |
|
|
406 |
|
|
|
485 |
|
|
|
832 |
|
|
|
1,267 |
|
Zocor |
|
|
107 |
|
|
|
117 |
|
|
|
234 |
|
|
|
233 |
|
Propecia |
|
|
112 |
|
|
|
113 |
|
|
|
218 |
|
|
|
213 |
|
Claritin Rx |
|
|
65 |
|
|
|
58 |
|
|
|
186 |
|
|
|
157 |
|
Remeron |
|
|
57 |
|
|
|
59 |
|
|
|
117 |
|
|
|
110 |
|
Vasotec/Vaseretic |
|
|
59 |
|
|
|
63 |
|
|
|
116 |
|
|
|
122 |
|
Proscar |
|
|
53 |
|
|
|
56 |
|
|
|
113 |
|
|
|
114 |
|
Infectious Disease |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Isentress |
|
|
337 |
|
|
|
267 |
|
|
|
629 |
|
|
|
499 |
|
Cancidas |
|
|
168 |
|
|
|
150 |
|
|
|
326 |
|
|
|
303 |
|
PegIntron |
|
|
154 |
|
|
|
185 |
|
|
|
319 |
|
|
|
371 |
|
Primaxin |
|
|
136 |
|
|
|
158 |
|
|
|
272 |
|
|
|
317 |
|
Invanz |
|
|
103 |
|
|
|
83 |
|
|
|
189 |
|
|
|
158 |
|
Avelox |
|
|
61 |
|
|
|
59 |
|
|
|
167 |
|
|
|
165 |
|
Noxafil |
|
|
56 |
|
|
|
50 |
|
|
|
110 |
|
|
|
99 |
|
Rebetol |
|
|
48 |
|
|
|
55 |
|
|
|
100 |
|
|
|
111 |
|
Crixivan/Stocrin |
|
|
50 |
|
|
|
48 |
|
|
|
95 |
|
|
|
100 |
|
Neurosciences and Ophthalmology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maxalt |
|
|
131 |
|
|
|
133 |
|
|
|
304 |
|
|
|
268 |
|
Cosopt/Trusopt |
|
|
122 |
|
|
|
123 |
|
|
|
236 |
|
|
|
238 |
|
Oncology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Temodar |
|
|
234 |
|
|
|
271 |
|
|
|
481 |
|
|
|
545 |
|
Emend |
|
|
120 |
|
|
|
93 |
|
|
|
207 |
|
|
|
177 |
|
Intron A |
|
|
47 |
|
|
|
51 |
|
|
|
96 |
|
|
|
105 |
|
Respiratory and Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Singulair |
|
|
1,354 |
|
|
|
1,258 |
|
|
|
2,682 |
|
|
|
2,423 |
|
Remicade |
|
|
842 |
|
|
|
669 |
|
|
|
1,595 |
|
|
|
1,343 |
|
Nasonex |
|
|
323 |
|
|
|
338 |
|
|
|
696 |
|
|
|
658 |
|
Clarinex |
|
|
209 |
|
|
|
191 |
|
|
|
364 |
|
|
|
355 |
|
Arcoxia |
|
|
100 |
|
|
|
95 |
|
|
|
214 |
|
|
|
190 |
|
Simponi |
|
|
75 |
|
|
|
18 |
|
|
|
129 |
|
|
|
28 |
|
Asmanex |
|
|
47 |
|
|
|
56 |
|
|
|
107 |
|
|
|
107 |
|
Proventil |
|
|
37 |
|
|
|
55 |
|
|
|
80 |
|
|
|
112 |
|
Dulera |
|
|
25 |
|
|
|
|
|
|
|
37 |
|
|
|
|
|
Vaccines (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ProQuad/M-M-R II/Varivax |
|
|
291 |
|
|
|
340 |
|
|
|
535 |
|
|
|
659 |
|
Gardasil |
|
|
277 |
|
|
|
219 |
|
|
|
490 |
|
|
|
451 |
|
RotaTeq |
|
|
148 |
|
|
|
139 |
|
|
|
272 |
|
|
|
231 |
|
Zostavax |
|
|
122 |
|
|
|
18 |
|
|
|
146 |
|
|
|
114 |
|
Pneumovax |
|
|
64 |
|
|
|
59 |
|
|
|
143 |
|
|
|
110 |
|
Womens Health and Endocrine |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fosamax |
|
|
221 |
|
|
|
241 |
|
|
|
429 |
|
|
|
472 |
|
NuvaRing |
|
|
154 |
|
|
|
145 |
|
|
|
297 |
|
|
|
280 |
|
Follistim AQ |
|
|
143 |
|
|
|
137 |
|
|
|
276 |
|
|
|
270 |
|
Implanon |
|
|
81 |
|
|
|
51 |
|
|
|
141 |
|
|
|
101 |
|
Cerazette |
|
|
66 |
|
|
|
49 |
|
|
|
125 |
|
|
|
104 |
|
Other pharmaceutical (2) |
|
|
948 |
|
|
|
941 |
|
|
|
1,697 |
|
|
|
1,888 |
|
|
Total Pharmaceutical segment sales |
|
|
10,360 |
|
|
|
9,638 |
|
|
|
20,179 |
|
|
|
19,303 |
|
|
Other segment sales (3) |
|
|
1,665 |
|
|
|
1,525 |
|
|
|
3,275 |
|
|
|
3,095 |
|
|
Total segment sales |
|
|
12,025 |
|
|
|
11,163 |
|
|
|
23,454 |
|
|
|
22,398 |
|
|
Other (4) |
|
|
126 |
|
|
|
183 |
|
|
|
278 |
|
|
|
370 |
|
|
|
|
$ |
12,151 |
|
|
$ |
11,346 |
|
|
$ |
23,732 |
|
|
$ |
22,768 |
|
|
|
|
|
(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 $306 million and $241 million for the second
quarter of 2011 and 2010, respectively, and was $628 million and $605 million for the first
six 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. |
- 38 -
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 $1.3 billion and $1.1 billion
for the three months ended June 30, 2011 and 2010, respectively, and $2.5 billion and $2.3 billion
for the six months ended June 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 $592 million in the second quarter of 2011, an increase of 5% compared with the
second quarter of 2010, and were $1.2 billion for the first six 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 (marketed outside the United States as
Inegy), a combination product containing the active ingredients of both Zetia and Zocor, were $459
million and $939 million for the second quarter and first six months of 2011, respectively,
representing declines of 6% and 3%, respectively, compared with the same periods in 2010. These
results reflect volume declines in the United States, partially offset by growth in international
markets.
In June 2011, Merck announced changes to the prescribing information in the United States for
the highest dose of simvastatin, 80 mg, and the use of simvastatin with certain other medicines.
Simvastatin is a cholesterol-lowering medicine developed by Merck (marketed as Zocor) that is now
widely available in generic form; simvastatin is also a component of Vytorin. The changes follow a
U.S. Food and Drug Administration (FDA) review, announced by the agency in March 2010, of the
risk of muscle injury (called myopathy, including its most serious form, rhabdomyolysis) with the
highest dose of simvastatin. Merck has updated the U.S. prescribing information both to limit the
use of the high dose of simvastatin, 80 mg, which at the time of the label change was being taken by approximately 12% of U.S. simvastatin
users, to patients who have been taking that prescribed amount chronically (e.g., for 12 months or
more) without evidence of muscle toxicity; and, in addition, to contraindicate and/or limit the
dose of simvastatin when used with certain drugs where the combined use may increase the risk of
myopathy and rhabdomyolysis. Prescribing information for Zocor has included information about the
risk of myopathy and rhabdomyolysis since the initial approval of the medicine in 1991 and has
described the dose-related nature of this risk since 2002. The FDAs review concluded that there is
an increased risk of myopathy, including rhabdomyolysis, with simvastatin 80 mg compared with other
statin therapies that can provide similar or greater reduction in LDL cholesterol and compared with
lower doses of simvastatin. This increased risk is highest during the first year of treatment and
then notably decreases.
Supplemental New Drug Applications (sNDAs) for Vytorin and Zetia have been accepted for
standard review by 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.
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 an immaterial 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 European Union (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. Brinavess has been launched in more than 10 European countries.
Diabetes and Obesity
Global sales of Januvia, Mercks dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment
of type 2 diabetes, were $779 million in the second quarter of 2011 and $1.5 billion for the first
six months of 2011, representing increases of 30% and 37%,
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.
- 39 -
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 $321 million for the second quarter of 2011, an increase of 47% compared with the second
quarter of 2010, and were $626 million for the first six months of 2011, an increase of 50% compared
with the first six months of 2010, reflecting growth both in the United States and internationally.
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 is responding to the questions raised by
the FDA.
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 16% in the second quarter of 2011
and 34% in the first six 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 is experiencing a significant decline in
Cozaar and Hyzaar sales
and the Company expects such decline to continue.
Other products contained in the Diversified Brands franchise include among others, Zocor, a
statin for modifying cholesterol; Propecia, a product for the treatment of male pattern hair loss;
prescription Claritin for the treatment of seasonal outdoor allergies and year-round indoor
allergies; Remeron, an antidepressant; Vasotec/Vaseretic for hypertension and/or heart failure; and
Proscar, a urology product for the treatment of symptomatic benign prostate enlargement. Remeron
lost market exclusivity in the United States in January 2010 and in certain markets in the EU in
September 2010.
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 $337 million in the second quarter of 2011, an increase of 26%
compared with the second quarter of 2010, and were $629 million in the first six months of 2011, an
increase of 26% compared with the first six months of 2010, reflecting positive performance in the
United States and Europe. Isentress works by inhibiting the insertion of HIV DNA into human DNA by
the integrase enzyme. Inhibiting integrase from performing this essential function helps to limit
the ability of the virus to replicate and infect new cells.
Worldwide sales of PegIntron for treating chronic hepatitis C were $154 million for the second
quarter of 2011, a decline of 17% compared with the second quarter of 2010, and were $319 million for
the first six months of 2011, a decrease of 14% 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 is also approved
in Brazil.
Sales of Victrelis were $21 million for the second quarter of 2011.
Sales of Primaxin, an anti-bacterial product, were $136 million in the second quarter of 2011
and $272 million in the first six months of 2011, representing declines of 13% and 14% 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
approved 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,
an anti-fungal product; Invanz for the treatment of certain infections; Avelox, a fluoroquinolone
antibiotic for the treatment of certain respiratory and skin infections; Noxafil for the prevention
of invasive fungal infections; Rebetol for use in combination with PegIntron for treating chronic
hepatitis C; and Crixivan and Stocrin, antiretroviral therapies for the treatment of HIV infection.
The compound patent that provides U.S. market exclusivity for Crixivan expires in 2012.
- 40 -
Neurosciences and Ophthalmology
Global sales of Maxalt, Mercks tablet for the acute treatment of migraine, were $131 million
for the second quarter of 2011, a decline of 1% compared with the second quarter of 2010, and were
$304 million for the first six months of 2011, an increase of 14% compared with the first six
months of 2010, reflecting a higher inventory level in the United States. The compound patent that
provides market exclusivity for Maxalt in the United States expires in June 2012 (although the six
month Pediatric Market Exclusivity may extend this date to December 2012). In addition, the patent
for Maxalt will expire in a number of major European markets in 2013. The Company anticipates that
sales in the United States and in these European markets will decline significantly after these
patent expiries.
Worldwide sales of ophthalmic products Cosopt and Trusopt were $122 million in the second
quarter of 2011, a decline of 1% compared with the second quarter of 2010, and were $236 million in
the first six months of 2011, a decrease of 1% compared with the same period in 2010, reflecting
lower sales in Europe largely offset by higher sales in Japan. The patent that provided U.S.
market exclusivity for Cosopt and Trusopt expired in October 2008. Trusopt has also lost market
exclusivity in a number of major European markets. The patent for Cosopt will expire in a number
of major European markets in March 2013 and the Company expects sales in those markets to decline
significantly thereafter.
In April 2011, the New Drug Application (NDA) for Mercks investigational preservative-free
formulation of Cosopt ophthalmic solution, containing a combination topical carbonic anhydrase
inhibitor and beta-andrenergic receptor blocking agent, was accepted for standard review by the
FDA.
Bridion, for the reversal of certain muscle relaxants during surgery, is currently approved
and has launched in many countries outside of the United States. Sales of Bridion were $89 million
for the first six months of 2011. 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.
Merck launched a black cherry flavor of the sublingual tablet to provide an additional taste
option. Merck continues to monitor and assess Saphris/Sycrest and the related intangible asset.
If increasing the brand awareness, the additional flavor option, or Lundbecks launch of the
product in the EU is not successful, the Company may take a non-cash impairment charge with respect
to Saphris/Sycrest, and such charge could be material.
The Neurosciences and Ophthalmology franchise also included the products Subutex/Suboxone for
the treatment of opiate addiction. In 2010, Merck sold the rights to Subutex/Suboxone back to
Reckitt Benckiser Group PLC. Sales of Subutex/Suboxone were $51 million and $104 million for the second
quarter and first six months of 2010, respectively.
Oncology
Sales of Temodar (marketed as Temodal outside the United States), a treatment for certain
types of brain tumors, were $234 million for the second quarter of 2011, a decline of 14% compared
with the second quarter of 2010, and were $481 million for the first six months of 2011, a decline
of 12% compared with the first six months of 2010, primarily reflecting generic competition in
Europe. Temodar lost patent exclusivity in the EU in 2009.
Global sales of Emend, a treatment for chemotherapy-induced nausea and vomiting, were $120
million in the second quarter of 2011, an increase of 29% compared with the second quarter of 2010,
and were $207 million in the first six months of 2011, an increase of 17% compared with the same
period in 2010, reflecting growth in Europe and the United States.
Other products in the Oncology franchise include among others, Intron A for treating melanoma.
Marketing rights for Caelyx for the treatment of ovarian cancer, metastatic breast cancer and
Kaposis sarcoma transitioned to Johnson & Johnson as of
- 41 -
December 31, 2010. Sales of Caelyx were $66 million and $139 million in the second quarter and
first six 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 $1.4 billion for the second
quarter of 2011, an increase of 8% compared with the second quarter of 2010 reflecting growth in
Japan and favorable pricing in the United States, partially offset by volume declines in the United
States. Sales for the first six months of 2011 were $2.7 billion, an increase of 11% compared with
the first six months of 2010 reflecting favorable pricing in the United States and growth
internationally, particularly in Japan, due in part to the favorable effect of foreign exchange.
Singulair continues to be the number one prescribed branded product in the U.S. respiratory market.
Full year U.S. sales of Singulair were $3.2 billion in 2010. The patent that provides U.S. market
exclusivity for Singulair expires in August 2012. The Company expects that within the two years
following patent expiration, it will lose substantially all U.S. sales of Singulair, with most of
those declines coming in the first full year following patent expiration. In addition, the patent
for Singulair will expire in a number of major European markets in August 2012 and the Company
expects sales of Singulair in those markets will decline significantly thereafter (although the six
month Pediatric Market Exclusivity may extend this date in some markets to February 2013).
Sales of Remicade, a treatment for inflammatory diseases, were $842 million for the second
quarter of 2011, an increase of 26% compared with the second quarter of 2010, and were $1.6 billion
for the first six months of 2011, an increase of 19% compared with the same period in 2010.
Foreign exchange favorably affected sales performance in both periods. The increased sales in both
periods reflect positive performance in Canada and a number of European markets. 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 9 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. 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 $75 million in the second quarter of 2011 compared with
$18 million in the second quarter of 2010 and were $129 million for the first six months of 2011
compared with $28 million for the first six months of 2010.
Global sales of Nasonex, an inhaled nasal corticosteroid for the treatment of nasal allergy
symptoms, were $323 million for the second quarter of 2011, a decline of 4% compared with the
second quarter of 2010 reflecting declines in the United States, partially offset by growth
internationally. Sales of Nasonex were $696 million for the first six months of 2011, an increase
of 6% compared with the same period in 2010, driven largely by positive performance
internationally, particularly in Japan, partially offset by declines in the United States.
Global sales of Clarinex (marketed as Aerius in many countries outside the United States), a
non-sedating antihistamine, were $209 million for the second quarter of 2011, an increase of 9%
compared with the second quarter of 2010. Sales of Clarinex for the first six months of 2011 were
$364 million, an increase of 3% compared with the first six months of 2010.
Other products included in the Respiratory and Immunology franchise include among others,
Arcoxia for the treatment of arthritis and pain; Asmanex, an inhaled corticosteroid for asthma;
Proventil inhalation aerosol for the relief of bronchospasm; and Dulera inhalation aerosol for the
treatment of asthma. An sNDA for Dulera for the treatment of chronic obstructive pulmonary disease
(COPD) has been accepted for review by the FDA.
Dulera is currently indicated in the United
States for the treatment of asthma.
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 27% in the second quarter of 2011 to $277
million and increased 9% for the first six months of 2011 to $490 million reflecting strong public
sector sales. 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
- 42 -
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.
Global sales of RotaTeq, a vaccine to help protect against rotavirus gastroenteritis in
infants and children, recorded by Merck were $148 million in the second quarter of 2011, an
increase of 7% compared with the second quarter of 2010. Sales for the first six months of 2011
were $272 million, an increase of 18% compared with the same period in 2010, reflecting favorable
public sector inventory fluctuations.
In recent years, the Company has experienced difficulties in producing its varicella zoster
virus (VZV)-containing vaccines. These difficulties have resulted in supply constraints for
ProQuad, Varivax and Zostavax. The Company is manufacturing bulk varicella and is producing doses
of Varivax and Zostavax.
A limited quantity of ProQuad, a pediatric combination vaccine to help protect against
measles, mumps, rubella and varicella, one of the VZV-containing vaccines, became available in the
United States for ordering in the second quarter of 2010. Sales of ProQuad were $47 million in the
second quarter of 2010. This supply has been exhausted and the Company does not anticipate
availability of ProQuad for the remainder of 2011. Sales of ProQuad as recorded by Merck were $37
million in the first quarter of 2011.
Mercks sales of Varivax, a vaccine to help prevent chickenpox (varicella), were $206 million
for the second quarter of 2011 compared with $215 million for the second quarter of 2010 and were
$350 million for the first six months of 2011 compared with $451 million for the first six months
of 2010. Sales in the first six months of 2010 include $48 million of revenue as a result of
government purchases for the U.S. Centers for Disease Control and Preventions Strategic National
Stockpile. Mercks sales of M-M-R II, a vaccine to help protect against measles, mumps and
rubella, were $86 million for the second quarter of 2011 compared with $78 million for the second
quarter of 2010 and were $149 million for the first six months of 2011 compared with $160 million
for the first six months of 2010. Sales of Varivax and M-M-R II in the second quarter of 2011
benefited from the unavailability of ProQuad as noted above.
Mercks sales of Zostavax, a vaccine to help prevent shingles (herpes zoster), were $122
million for the second quarter of 2011 as compared with $18 million in the second quarter of 2010
and were $146 million in the first six months of 2011 compared with $114 million in the first six
months of 2010. The Company filled a significant number of backorders during the second quarter of
2011. 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.
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, a vaccine
against hepatitis B, is now available.
Womens Health and Endocrine
Worldwide sales for Fosamax and Fosamax Plus D (marketed as Fosavance throughout the EU and as
Fosamac in Japan) for the treatment and, in the case of Fosamax, prevention of osteoporosis were
$221 million for the second quarter of 2011, representing a decline of 9% over the comparable
period of 2010, and were $429 million for the first six months of 2011, a decrease of 9% 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 significant sales declines within the Fosamax product franchise and the Company
expects the declines to continue.
Worldwide sales of NuvaRing, a contraceptive product, were $154 million for the second quarter
of 2011, an increase of 6% compared with the second quarter of 2010, and were $297 million for the
first six months of 2011, an increase of 6% compared with the first six months of 2010. Global
sales of Follistim AQ (marketed in most countries outside the United States as Puregon), a
fertility treatment, were $143 million for the second quarter of 2011, an increase of 4% compared
with the second quarter of 2010, and were $276 million for the first six months of 2011, an
increase of 2% compared with the first six months of 2010. Puregon lost market exclusivity in the
EU in August 2009.
- 43 -
Other products contained in the Womens Health and Endocrine franchise include among others,
Implanon, a single-rod subdermal contraceptive implant; and Cerazette, a progestin only oral
contraceptive.
The Company is currently experiencing difficulty manufacturing certain womens health
products. The Company is working to resolve these issues.
Other
Animal Health
Animal Health includes pharmaceutical and vaccine products for the prevention, treatment and
control of disease in all major farm and companion animal species. Animal Health sales are
affected by intense competition and the frequent introduction of generic products. Global sales of
Animal Health products totaled $802 million for the second quarter of 2011, an increase of 10%
compared with the second quarter of 2010, and were $1.6 billion for the first six months of 2011,
an increase of 8% compared with the first six months of 2010. Foreign exchange favorably affected
global sales performance by 8% and 5%, respectively, in the second quarter and first six months of
2011. The increased sales in both periods reflect positive performance in cattle, companion animal
and poultry products.
Mercks
animal health division, formerly known as Intervet/Schering-Plough
Animal Health, is now using the new name, Merck Animal Health.
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 $541 million for the second quarter of 2011, comparable with the second quarter of 2010,
reflecting declines in Claritin due to a weak allergy season that were partially offset by increases in sun care products.
Consumer Care sales were $1.1 billion for the first six months of 2011, an increase of 2% compared
with the first six months of 2010, reflecting strong performance of Coppertone. Consumer Care
product sales are affected by competition, frequent competitive product introductions and consumer
spending patterns.
Alliances
AstraZeneca has an option to buy Old Mercks interest in Nexium and Prilosec, exercisable in
2012, and the Company believes that it is likely that AstraZeneca will exercise that option (see
Selected Joint Venture and Affiliate Information below). If AstraZeneca does exercise the
option, the Company will no longer 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 next 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 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 $808 million and $830 million in the
second quarter of 2011 and 2010, respectively, and $921 million and $1.1 billion for the first six
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 upon completion of the
program of
approximately $4.0 billion to $4.6 billion, and annual
savings by the end of 2013 of approximately $3.5 billion to $4.0 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.
- 44 -
In October 2008, Old Merck announced a global restructuring program (the 2008
Restructuring Program) to reduce its cost structure, increase efficiency, and enhance
competitiveness. As part of the 2008 Restructuring Program, the Company expects to eliminate
approximately 7,200 positions 6,800 active employees and 400 vacancies across the Company
worldwide by the end of 2011. Pretax restructuring costs of $1 million and $66 million were
recorded in the second quarter of 2011 and 2010, respectively, and $5 million and $131 million for
the first six 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 $4.3 billion for the second quarter of 2011, a decline of
6% compared with the second quarter of 2010, and were $8.3 billion for the first six months of
2011, a decline of 15% compared with the first six months of 2010. Costs in the second quarter of
2011 and 2010 include $1.2 billion and $1.1 billion, respectively, and for the first six months of
2011 and 2010 include $2.4 billion and $2.3 billion, respectively, of expenses for the amortization
of intangible assets recognized in the Merger. Additionally, expenses for the second quarter and
first six months of 2010 included $561 million and $1.8 billion of amortization of purchase
accounting adjustments to Schering-Ploughs inventories also recognized as a result of the Merger.
Costs in the second quarter and first six 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
the Merger and such charges could be material. Also included in materials and production costs
were costs associated with restructuring activities which amounted to $109 million and $224 million
in the second quarter of 2011 and 2010, respectively, and $181 million and $281 million in the
first six 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. (See Note 2 to the interim consolidated financial
statements.)
Gross margin was 64.7% in the second quarter of 2011 compared with 59.9% in the second quarter
of 2010 and was 64.8% for the first six months of 2011 compared with 57.1% for the first six months
of 2010. The amortization of intangible assets and purchase accounting adjustments to inventories
recorded as a result of the Merger, as well as the restructuring and impairment charges noted above
and certain merger-related costs had an unfavorable effect on gross margin of 12.0 and 16.6
percentage points for the second quarter of 2011 and 2010, respectively, and 11.9 and 18.9
percentage points for the first six months of 2011 and 2010, respectively. Excluding these
impacts, the gross margin improvements reflect the favorable effect of foreign exchange, as well as
changes in product mix and lower costs due to manufacturing efficiencies.
Marketing and administrative expenses were $3.5 billion in the second quarter of 2011, an
increase of 11% compared with the second quarter of 2010, and were $6.7 billion for the first six
months of 2011, an increase of 5% compared with the first six 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 second quarter and first six months of 2011 included $23 million
and $46 million, respectively, of restructuring costs, primarily related to accelerated
depreciation for facilities to be closed or divested. Separation costs associated with sales force
reductions have been incurred and are reflected in Restructuring costs as discussed below.
Marketing and administrative expenses included $77 million and $75 million of acquisition-related
costs in the second quarter of 2011 and 2010, respectively, and $135 million and $154 million for
the first six months of 2011 and 2010, respectively, consisting largely of integration costs
related to the Merger, as well as severance costs associated with the acquisition of Inspire which
are not part of the Companys formal restructuring programs. Additionally, marketing and
administrative expenses in the second quarter and first half of 2011 include $43 million and $85
million, respectively, of expenses for the estimated annual health care reform fee which the
Company will be required to pay beginning in 2011 as part of U.S. health care reform legislation.
The Company is amortizing the estimated cost for 2011 on a straight-line basis.
Research and development expenses were $1.9 billion for the second quarter of 2011, a decline
of 11% compared with the second quarter of 2010, and were $4.1 billion for the first six months of
2011, a decrease of 3% compared with the first six months of 2010. During the second quarter and
first six months of 2011, the Company recorded $19 million and
$321 million, respectively, of in-process research
and development (IPR&D) impairment charges primarily for programs that had previously been
deprioritized and were deemed to have no alternative use during the period. During the first six
months of 2010, the Company recorded $27 million of
- 45 -
IPR&D impairment charges attributable to
compounds identified during the Companys pipeline prioritization review that were abandoned and
determined to have either no alternative use or were returned to the respective licensor. The
Company may recognize
additional non-cash impairment charges in the future for the cancellation of other legacy
Schering-Plough pipeline programs that were measured at fair value and capitalized in connection
with the Merger and such charges could be material. Also, expenses in the second quarter of 2011
and 2010 reflect $16 million and $144 million, respectively, and for the first six months of 2011
and 2010 reflect $61 million and $150 million, respectively, of accelerated depreciation and asset
abandonment costs associated with restructuring activities. Research and development expenses in
2011 were favorably affected by cost savings resulting from restructuring activities.
Additionally, costs in the second quarter and first six months of 2010 include a $50 million
payment related to the restructuring of Mercks agreement with ARIAD Pharmaceuticals, Inc.
Restructuring costs, primarily representing separation and other related costs associated with
restructuring activities, were $668 million and $654 million for the second quarter and first six
months of 2011, respectively, nearly all of which related to the Merger Restructuring Program.
Costs for the first six 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 $526 million and $814 million for the second quarter and first
six months of 2010, respectively, of which $515 million and $767 million, respectively, related to
the Merger Restructuring Program, $19 million and $55 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
645 positions in the second quarter of 2011 of which 585 related to the Merger Restructuring
Program and 60 related to the 2008 Restructuring Program. During the first six months of 2011,
Merck eliminated approximately 1,515 positions of which 1,335 related to the Merger Restructuring
Program and 180 related to the 2008 Restructuring Program. For the second quarter of 2010, Merck
eliminated 2,705 positions of which 2,435 related to the Merger Restructuring Program, 240 related
to the 2008 Restructuring Program and the remainder to the legacy Schering-Plough Productivity
Transformation Program. Merck eliminated 8,435 positions in the first six months of 2010, of which
7,585 related to the Merger Restructuring Program, 775 related to the 2008 Restructuring Program
and the remainder to the legacy Schering-Plough Productivity Transformation Program. These
position eliminations are comprised of actual headcount reductions, and the elimination of
contractors and vacant positions. Also included in restructuring costs are curtailment, settlement
and termination charges on pension and other postretirement benefit plans and shutdown costs. For
segment reporting, restructuring costs are unallocated expenses. Additional costs associated with
the Companys restructuring activities are included in Materials and production, Marketing and
administrative and Research and development. (See Note 2 to the interim consolidated financial
statements.)
Equity income from affiliates, which reflects the performance of the Companys joint ventures
and other equity method affiliates, primarily AZLP, was $55 million and $43 million in the second
quarter of 2011 and 2010, respectively, and was $193 million and $180 million in the first six
months of 2011 and 2010, respectively. (See Selected Joint Venture and Affiliate Information
below.)
Other (income) expense, net was $121 million of expense in the second quarter of 2011 compared
with $281 million of income in the second quarter of 2010. The second quarter of 2010 reflects
$443 million of income recognized upon AstraZenecas exercise of the asset option (see Selected
Joint Venture and Affiliate Information below). Other (income) expense, net was $744 million of
expense in the first six months of 2011 compared with $113 million of income in the first six
months 2010. Included in other (income) expense, net during the first six 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 9 to the interim consolidated financial statements)
and a $127 gain on the sale of certain manufacturing facilities and related assets. Included in
other (income) expense, net in the first six months of 2010 was $443 million of income
recognized upon AstraZenecas asset option exercise noted above and $102 million of income on the
settlement of certain disputed royalties. Additionally, during the first six months of 2010, the
Company recognized exchange losses of $80 million related to a Venezuelan currency devaluation.
Effective January 11, 2010, the Venezuelan government devalued its currency from at BsF 2.15 per
U.S. dollar to a two-tiered official exchange rate at (1) the essentials rate at BsF 2.60 per
U.S. dollar and (2) the non-essentials rate at BsF 4.30 per U.S. dollar. In January 2010, Merck
was required to remeasure its local currency operations in Venezuela to U.S. dollars as the
Venezuelan economy was determined to be hyperinflationary. Throughout 2010, the Company settled
its transactions at the essentials rate and therefore remeasured monetary assets and liabilities
using the essentials rate. In December 2010, the Venezuelan government announced it would
eliminate the essentials rate and, effective January 1, 2011, all transactions would be settled at
the official rate of at BsF 4.30 per U.S. dollar. As a result of this announcement, the Company
remeasured its December 31, 2010 monetary assets and liabilities at the new official rate.
- 46 -
Segment Profits
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pharmaceutical segment profits |
|
$ |
6,443 |
|
|
$ |
5,987 |
|
|
$ |
12,659 |
|
|
$ |
11,727 |
|
Other non-reportable segment profits |
|
|
655 |
|
|
|
627 |
|
|
|
1,371 |
|
|
|
1,347 |
|
Other |
|
|
(5,426 |
) |
|
|
(5,373 |
) |
|
|
(10,629 |
) |
|
|
(11,218 |
) |
|
Income before income taxes |
|
$ |
1,672 |
|
|
$ |
1,241 |
|
|
$ |
3,401 |
|
|
$ |
1,856 |
|
|
Segment profits are comprised of segment revenues less certain elements of materials and
production costs and operating expenses, including components of equity income or loss from
affiliates and depreciation and amortization expenses. For internal management reporting presented
to the chief operating decision maker, Merck does not allocate production costs, other than
standard costs, research and development expenses or general and administrative expenses, nor the
cost of financing these activities. Separate divisions maintain responsibility for monitoring and
managing these costs, including depreciation related to fixed assets utilized by these divisions
and, therefore, they are not included in segment profits. Also excluded from the determination of
segment profits are the arbitration settlement charge in 2011, the gain on AstraZenecas asset
option exercise 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.
Pharmaceutical segment profits rose 8% in both the second quarter and in the first six months
of 2011 driven largely by the increase in sales and the gross margin improvement discussed above.
The effective tax rates of (22.8%) for the second quarter of 2011 and 8.1% for the first six
months of 2011 reflect the net favorable impact of approximately $700 million relating to the
settlement of Old Mercks 2002-2005 federal income tax audit, as well as 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. The tax rates also
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 six
months of 2011 reflects the impact of the $500 million charge related to the resolution of the
arbitration proceeding with Johnson & Johnson. The effective tax rates of 37.1% for the second
quarter of 2010 and 40.2% for the first six months of 2010, as compared with the statutory rate of
35%, reflect the unfavorable impact of purchase accounting charges AstraZenecas asset option
exercise and restructuring charges, largely offset by the beneficial impact of foreign earnings.
In addition, the effective tax rate for the first six 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.
Net income attributable to Merck & Co., Inc. was $2.0 billion for the second quarter of 2011
compared with $752 million for the second quarter of 2010 and was $3.1 billion for the first six
months of 2011 compared with $1.1 billion for the first six months of 2010. Earnings per common
share assuming dilution attributable to Merck & Co., Inc. common shareholders (EPS) for the
second quarter of 2011 were $0.65 compared with $0.24 in the second quarter of 2010 and were $0.98
in the first six months of 2011 compared with $0.33 in the first six months of 2010. The increases
in net income and EPS in the second quarter and first six months of 2011 were primarily due to the
favorable impact of the tax items noted above and lower amortization of inventory step-up,
partially offset by higher intangible asset impairment charges and, for the year-to-date period,
higher restructuring costs.
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
- 47 -
measured on this basis along with other
performance metrics. Senior managements annual compensation is derived in part using non-GAAP
income and non-GAAP EPS.
A reconciliation between GAAP financial measures and non-GAAP financial measures is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in millions, except per share amounts) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Pretax income as reported under GAAP |
|
$ |
1,672 |
|
|
$ |
1,241 |
|
|
$ |
3,401 |
|
|
$ |
1,856 |
|
Increase (decrease) for excluded items: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related costs |
|
|
1,440 |
|
|
|
1,747 |
|
|
|
3,097 |
|
|
|
4,207 |
|
Costs related to restructuring programs |
|
|
816 |
|
|
|
894 |
|
|
|
942 |
|
|
|
1,245 |
|
Other items: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arbitration settlement charge |
|
|
|
|
|
|
|
|
|
|
500 |
|
|
|
|
|
Loss (gain) on sale of manufacturing
facilities and related assets |
|
|
7 |
|
|
|
|
|
|
|
(127 |
) |
|
|
|
|
Gain on AstraZeneca asset option exercise |
|
|
|
|
|
|
(443 |
) |
|
|
|
|
|
|
(443 |
) |
|
|
|
|
3,935 |
|
|
|
3,439 |
|
|
|
7,813 |
|
|
|
6,865 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on income as reported under GAAP |
|
|
(382 |
) |
|
|
461 |
|
|
|
276 |
|
|
|
746 |
|
Estimated tax benefit on excluded items |
|
|
407 |
|
|
|
242 |
|
|
|
738 |
|
|
|
892 |
|
Tax benefit from settlement of federal income tax audit |
|
|
700 |
|
|
|
|
|
|
|
700 |
|
|
|
|
|
Tax benefit from foreign and state tax rate changes |
|
|
230 |
|
|
|
|
|
|
|
230 |
|
|
|
|
|
Tax charge related to U.S. health care reform legislation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(147 |
) |
|
|
|
|
955 |
|
|
|
703 |
|
|
|
1,944 |
|
|
|
1,491 |
|
|
Non-GAAP net income |
|
|
2,980 |
|
|
|
2,736 |
|
|
|
5,869 |
|
|
|
5,374 |
|
|
Less: Net income attributable to noncontrolling interests |
|
|
30 |
|
|
|
28 |
|
|
|
58 |
|
|
|
59 |
|
|
Non-GAAP net income attributable to Merck & Co., Inc. |
|
$ |
2,950 |
|
|
$ |
2,708 |
|
|
$ |
5,811 |
|
|
$ |
5,315 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPS assuming dilution as reported under GAAP |
|
$ |
0.65 |
|
|
$ |
0.24 |
|
|
$ |
0.98 |
|
|
$ |
0.33 |
|
EPS difference (1) |
|
|
0.30 |
|
|
|
0.62 |
|
|
|
0.89 |
|
|
|
1.36 |
|
|
Non-GAAP EPS assuming dilution |
|
$ |
0.95 |
|
|
$ |
0.86 |
|
|
$ |
1.87 |
|
|
$ |
1.69 |
|
|
|
|
|
(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.
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 charge related to the arbitration
- 48 -
settlement (see Note 9 to the interim consolidated financial statements), the gain associated
with the sales of certain manufacturing facilities and related assets and the gain recognized upon
AstraZenecas asset option exercise (see Note 13 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 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 is also approved
in Brazil.
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.
In June 2011,
the Japanese Ministry of Health, Labour and Welfare approved Cubicin (daptomycin
for injection), an antibacterial agent with activity against
methicillin-resistant Staphylococcus
aureus (MRSA), for use in treatment of MRSA infections in Japan. Under a licensing agreement
signed in 2007 between Merck and Cubist Pharmaceuticals, Merck obtained the rights for development
and distribution of Cubicin in Japan.
Also in June 2011, detailed results from the Phase III SUCCEED (Sarcoma Multi-Center Clinical
Evaluation of the Efficacy of Ridaforolimus) clinical trial were presented during the 2011 American
Society of Clinical Oncology annual meeting. SUCCEED evaluated oral ridaforolimus, an
investigational mTOR inhibitor, in patients with metastatic soft-tissue or bone sarcomas who
previously had a favorable response to chemotherapy. In this patient population, ridaforolimus
improved progression-free survival compared to placebo, the primary endpoint of the study. Based
on these results, Merck plans to submit an NDA for ridaforolimus to the FDA and a marketing
application in the EU in 2011.
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, which related
to the resolution of pre-approval inspection issues. Merck is responding to the questions raised
by the FDA.
MK-0653C, Zetia
(ezetimibe) combined with atorvastatin was accepted for standard review by the
FDA for the treatment of primary or mixed hyperlipidemia. Final FDA approval of this
application may be delayed if Pfizer Inc. (Pfizer) takes legal action asserting certain of its
patent rights in respect of atorvastatin. The impact of any such legal action by Pfizer would be a
bar on FDA approval of the Companys NDA up to for 30 months pursuant to the FDAs automatic stay,
subject to being shortened or lengthened by a court decision, or shortened by an agreement between the parties.
Merck is discontinuing the clinical development program for telcagepant, the Companys
investigational calcitonin gene-related peptide receptor antagonist for the treatment of acute
migraine. The decision is based on an assessment of data across the clinical program, including
findings from a recently completed six-month Phase III study.
In June 2011, Merck and Intercell AG announced that following a detailed analysis of the data
from the Phase II/III clinical trial evaluating V710, an investigational vaccine for the prevention
of Staphylococcus aureus infection, the independent Data Monitoring Committee has unanimously
recommended termination of the study. The recommendation to terminate was made based upon both the
observation that V710 was unlikely to demonstrate a statistically significant clinical benefit as
well as a safety concern regarding overall mortality and multi-organ dysfunction that occurred with
greater frequency in vaccine recipients, compared with placebo recipients.
In April 2011, Merck and Sun Pharmaceutical Industries Ltd., a leading Indian multinational
pharmaceutical company, announced the creation of a joint venture to develop, manufacture and
commercialize new combinations and formulations of innovative,
branded generics that bring together
combinations of medicines using platform delivery technologies designed to enhance convenience for
patients in the emerging
markets.
- 49 -
The chart below reflects the Companys research pipeline as of July 29, 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 for legacy Schering-Plough compounds
SCH-number designations, and vaccine
candidates are given V-number designations. Candidates in Phase I, additional indications in the
same therapeutic area and additional claims, line extensions or formulations for in-line products
are not shown.
|
|
|
|
|
Phase II |
|
Phase III (Phase III entry date) |
|
Under Review |
Allergy
MK-8237 (SCH 900237), Immunotherapy(1)
Cancer
MK-0646 (dalotuzumab)
MK-7965 (SCH 727965) (dinaciclib)
Clostridium difficile Infection
MK-3415A
Contraception, Medicated IUS
MK-8342 (SCH 900342)
COPD
MK-7123 (SCH 527123) (navarixin)
Diabetes Mellitus
MK-3102
Hepatitis C
MK-5172
Insomnia
MK-3697
MK-6096
Osteoporosis
MK-5442
Overactive Bladder
MK-4618
Pneumoconjugate Vaccine
V114
Progeria
MK-6336 (SCH 066336) (lonafarnib)
Psoriasis
MK-3222 (SCH 900222)
|
|
Allergy
MK-7243 (SCH 697243), Grass pollen(1) (March 2008)
MK-3641 (SCH 039641), 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)
Cervical Cancer
V503 (HPV vaccine (9 valent)) (September 2008)
COPD
MK-0887A (SCH 418131) (Zenhale) (EU) (August 2006)
Diabetes
MK-0431C (sitagliptin/pioglitazone) (September 2008)
Fertility
MK-8962 (SCH 900962) (corifollitropin alfa
injection) (U.S.) (July 2006)
Hepatitis C
MK-7009 (vaniprevir)(3) (June 2011)
Herpes Zoster
V212 (inactivated VZV vaccine) (December 2010)
Insomnia
MK-4305 (suvorexant) (December 2009)
Neuromuscular Blockade Reversal
MK-8616 (SCH 900616) (Bridion) (U.S.) (November 2005)
Osteoporosis
MK-0822 (odanacatib) (September 2007)
Parkinsons Disease
MK-3814 (SCH 420814) (preladenant) (July 2010)
Pediatric Hexavalent Combination Vaccine
V419 (April 2011)
Sarcoma
MK-8669 (ridaforolimus) (October 2007)
Thrombosis
MK-5348 (SCH 530348) (vorapaxar) (September 2007)
|
|
Atherosclerosis
MK-0653C (ezetimibe/atorvastatin) (U.S.)
Contraception
MK-8175A (SCH 900121) (Zoely) (NOMAC/E2) (EU) (U.S.)
Diabetes
MK-0431D (sitagliptin/simvastatin) (U.S.)
MK-0431A XR (sitagliptin/extended-release
metformin) (U.S.) (4)
Glaucoma
MK-2452 (tafluprost) (U.S.)
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) In July 2011, Merck received a
Complete Response letter from the FDA.
|
- 50 -
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 $243
million and $237 million in the second quarter of 2011 and 2010, respectively, and were $430
million and $489 million for the first six 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 $66
million and $82 million for the second quarter of 2011 and 2010, respectively, and were $124
million and $165 million for the first six months of 2011 and 2010, respectively.
The Company records the results from its interest in AZLP and SPMSD in Equity income from
affiliates.
Other
In July 2011, Merck and Chinas Simcere Pharmaceutical Group (Simcere) announced the signing
of a framework agreement to establish a joint venture focused on serving Chinas rapidly expanding
health care needs by providing significantly improved access to quality medicines in major
therapeutic areas. This novel and innovative partnership will combine the extensive resources and
expertise of a global health care company and a leading Chinese pharmaceutical company in support
of Merck and Simceres goal of building a strategic partnership with development, registration,
manufacturing and sales capabilities. The initial focus of the partnership will be branded
pharmaceutical products for cardiovascular and metabolic diseases. Specifically, in the area of
cardiovascular disease, the partnership will offer a combined portfolio of selected medicines from
both companies, including Zocor, Cozaar and Renitec by Merck, and Xinta and Shufutan by Simcere.
In the metabolic disease area, the partnership will work to maximize access in China to
sitagliptin, a DPP-IV inhibitor for the treatment of type 2 diabetes. The establishment of this
joint venture is subject to satisfying certain agreed upon closing conditions.
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
($ in millions) |
|
2011 |
|
|
2010 |
|
|
Cash and investments |
|
$ |
16,156 |
|
|
$ |
14,376 |
|
Working capital |
|
|
16,605 |
|
|
|
13,423 |
|
Total debt to total liabilities and equity |
|
|
17.2 |
% |
|
|
16.9 |
% |
|
During the first six months of 2011, cash provided by operating activities was $4.6 billion
compared with $4.7 billion in the first six months of 2010. Cash
provided by operating activities during the
first six months of 2011, reflects the $500 million payment made to Johnson & Johnson 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 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
- 51 -
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 $943 million in the first six months of 2011
compared with $2.7 billion in the first six months of 2010 primarily reflecting higher proceeds
from the sales of securities and other investments and lower purchases of securities and other
investments. In addition, the Company received proceeds from the disposition of businesses in the
first six months of 2011. In 2010, the Company received proceeds from AstraZenecas asset option
exercise. In addition, the Company had a greater use of cash for acquisitions of businesses in the
first six months of 2011 as compared with the same period in 2010. Cash used in financing
activities in the first six months of 2011 was $2.4 billion compared with $2.5 billion in the first
six months of 2010. The lower use of cash in financing activities was primarily driven by lower
purchases of treasury stock, largely offset by a decrease in short-term borrowings and higher
payments on debt.
At June 30, 2011, the
total of worldwide cash and investments was $16.2 billion, including
$14.0 billion of cash, cash equivalents and short-term investments and $2.2 billion of long-term
investments. A substantial majority of these cash and investments, held by foreign subsidiaries, 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 $340 million (U.S. dollars) plus approximately $375 million (U.S.
dollars) of interest through June 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 $689 million and $680 million for the first six months of 2011
and 2010, respectively. Capital expenditures for full year 2011 are estimated to be $1.9
billion.
Dividends paid to stockholders were $2.4 billion for both the first six months of 2011 and
2010. 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 has approximately $6.1 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 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.
- 52 -
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 June 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
the quarter, affect the design and operation of controls over financial reporting. With
each implementation, the Company monitors the status of the business and financial operations and
believes that an effective control environment has been maintained post-implementation.
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.
- 53 -
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 June 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) |
April 1 - April 30, 2011 |
|
|
0 |
|
|
|
|
|
|
$ |
6,407 |
|
May 1 - May 31, 2011 |
|
|
3,451,700 |
|
|
$ |
36.90 |
|
|
$ |
6,279 |
|
June 1 - June 30, 2011 |
|
|
5,275,900 |
|
|
$ |
35.48 |
|
|
$ |
6,092 |
|
Total |
|
|
8,727,600 |
|
|
$ |
36.04 |
|
|
$ |
6,092 |
|
|
|
|
(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. |
- 54 -
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 June 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 Flow, and (iv) Notes to Consolidated
Financial Statements. |
- 55 -
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: August 8, 2011 |
/s/ Bruce N. Kuhlik
|
|
|
BRUCE N. KUHLIK |
|
|
Executive Vice President and General Counsel |
|
|
|
|
Date: August 8, 2011 |
/s/ John Canan
|
|
|
JOHN CANAN |
|
|
Senior Vice President Finance - Global Controller |
|
- 56 -
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 June 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 Flow, and (iv) Notes to Consolidated
Financial Statements. |
- 57 -