0000310158mrk:0000310158country:USmrk:BelsomraMembermrk:PharmaceuticalsegmentMemberus-gaap:OperatingSegmentsMembercountry:US2020-07-012020-09-30OperatingSegmentsMember2022-01-012022-09-30
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 20212022
OR
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☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period from ______ to ______
Commission File No. 1-6571
Merck & Co., Inc.
(Exact name of registrant as specified in its charter)
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New Jersey | 22-1918501 |
(State or other jurisdiction of incorporation) | (I.R.S. Employer Identification No.) |
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2000 Galloping Hill Road126 East Lincoln Avenue |
KenilworthRahway | New Jersey | 0703307065 |
(Address of principal executive offices) (zip code) |
(Registrant’s telephone number, including area code) (908) 740-4000
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| Not Applicable | |
(Former name, former address and former fiscal year, if changed since last report.) |
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Securities Registered pursuant to Section 12(b) of the Act: |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock ($0.50 par value) | MRK | New York Stock Exchange |
0.500% Notes due 2024 | MRK 24 | New York Stock Exchange |
1.875% Notes due 2026 | MRK/26 | New York Stock Exchange |
2.500% Notes due 2034 | MRK/34 | New York Stock Exchange |
1.375% Notes due 2036 | MRK 36A | New York Stock Exchange |
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 ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer | ☒ | Accelerated filer | ☐ |
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Non-accelerated filer | ☐ | Smaller reporting company | ☐ |
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| | Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares of common stock outstanding as of the close of business on October 31, 2021: 2,525,943,9362022: 2,535,395,974
Table of Contents
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PART I | | |
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Item 1. | | |
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Item 2. | | |
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Item 3. | | |
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Item 4. | | |
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PART II | | |
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Item 1. | | |
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Item 1A. | | |
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Item 2. | | |
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Item 6. | | |
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Part I - Financial Information
Item 1. Financial Statements
MERCK & CO., INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF INCOME
(Unaudited, $ in millions except per share amounts)
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2021 | | 2020 | | 2021 | | 2020 | | 2022 | | 2021 | | 2022 | | 2021 |
Sales | Sales | $ | 13,154 | | | $ | 10,929 | | | $ | 35,183 | | | $ | 30,570 | | Sales | $ | 14,959 | | | $ | 13,154 | | | $ | 45,453 | | | $ | 35,183 | |
Costs, Expenses and Other | Costs, Expenses and Other | | Costs, Expenses and Other | |
Cost of sales | Cost of sales | 3,450 | | | 3,013 | | | 9,752 | | | 8,589 | | Cost of sales | 3,934 | | | 3,450 | | | 13,530 | | | 9,752 | |
Selling, general and administrative | Selling, general and administrative | 2,336 | | | 2,060 | | | 6,804 | | | 6,336 | | Selling, general and administrative | 2,520 | | | 2,336 | | | 7,355 | | | 6,804 | |
Research and development | Research and development | 2,445 | | | 3,349 | | | 9,177 | | | 7,609 | | Research and development | 4,399 | | | 2,445 | | | 9,773 | | | 9,177 | |
Restructuring costs | Restructuring costs | 107 | | | 113 | | | 487 | | | 265 | | Restructuring costs | 94 | | | 107 | | | 288 | | | 487 | |
Other (income) expense, net | Other (income) expense, net | (450) | | | (312) | | | (1,007) | | | (637) | | Other (income) expense, net | 429 | | | (450) | | | 1,576 | | | (1,007) | |
| | 7,888 | | | 8,223 | | | 25,213 | | | 22,162 | | | 11,376 | | | 7,888 | | | 32,522 | | | 25,213 | |
Income from Continuing Operations Before Taxes | Income from Continuing Operations Before Taxes | 5,266 | | | 2,706 | | | 9,970 | | | 8,408 | | Income from Continuing Operations Before Taxes | 3,583 | | | 5,266 | | | 12,931 | | | 9,970 | |
Taxes on Income from Continuing Operations | Taxes on Income from Continuing Operations | 695 | | | 380 | | | 1,436 | | | 1,271 | | Taxes on Income from Continuing Operations | 330 | | | 695 | | | 1,423 | | | 1,436 | |
Net Income from Continuing Operations | Net Income from Continuing Operations | 4,571 | | | 2,326 | | | 8,534 | | | 7,137 | | Net Income from Continuing Operations | 3,253 | | | 4,571 | | | 11,508 | | | 8,534 | |
Less: Net Income Attributable to Noncontrolling Interests | Less: Net Income Attributable to Noncontrolling Interests | 4 | | | 2 | | | 9 | | | 1 | | Less: Net Income Attributable to Noncontrolling Interests | 5 | | | 4 | | | 6 | | | 9 | |
Net Income from Continuing Operations Attributable to Merck & Co., Inc. | Net Income from Continuing Operations Attributable to Merck & Co., Inc. | 4,567 | | | 2,324 | | | 8,525 | | | 7,136 | | Net Income from Continuing Operations Attributable to Merck & Co., Inc. | 3,248 | | | 4,567 | | | 11,502 | | | 8,525 | |
Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests | Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests | — | | | 617 | | | 766 | | | 2,025 | | Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests | — | | | — | | | — | | | 766 | |
Net Income Attributable to Merck & Co. Inc. | $ | 4,567 | | | $ | 2,941 | | | $ | 9,291 | | | $ | 9,161 | | |
Net Income Attributable to Merck & Co., Inc. | | Net Income Attributable to Merck & Co., Inc. | $ | 3,248 | | | $ | 4,567 | | | $ | 11,502 | | | $ | 9,291 | |
Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders: | Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders: | | Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders: | |
Income from Continuing Operations | Income from Continuing Operations | $ | 1.81 | | | $ | 0.92 | | | $ | 3.37 | | | $ | 2.82 | | Income from Continuing Operations | $ | 1.28 | | | $ | 1.81 | | | $ | 4.55 | | | $ | 3.37 | |
Income from Discontinued Operations | Income from Discontinued Operations | — | | | 0.24 | | | 0.30 | | | 0.80 | | Income from Discontinued Operations | — | | | — | | | — | | | 0.30 | |
Net Income | Net Income | $ | 1.81 | | | $ | 1.16 | | | $ | 3.67 | | | $ | 3.62 | | Net Income | $ | 1.28 | | | $ | 1.81 | | | $ | 4.55 | | | $ | 3.67 | |
Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders: | Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders: | | Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders: | |
Income from Continuing Operations | Income from Continuing Operations | $ | 1.80 | | | $ | 0.92 | | | $ | 3.36 | | | $ | 2.81 | | Income from Continuing Operations | $ | 1.28 | | | $ | 1.80 | | | $ | 4.53 | | | $ | 3.36 | |
Income from Discontinued Operations | Income from Discontinued Operations | — | | | 0.24 | | | 0.30 | | | 0.80 | | Income from Discontinued Operations | — | | | — | | | — | | | 0.30 | |
Net Income | Net Income | $ | 1.80 | | | $ | 1.16 | | | $ | 3.66 | | | $ | 3.61 | | Net Income | $ | 1.28 | | | $ | 1.80 | | | $ | 4.53 | | | $ | 3.66 | |
MERCK & CO., INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(Unaudited, $ in millions)
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2021 | | 2020 | | 2021 | | 2020 |
Net Income Attributable to Merck & Co., Inc. | $ | 4,567 | | | $ | 2,941 | | | $ | 9,291 | | | $ | 9,161 | |
Other Comprehensive Income (Loss) Net of Taxes: | | | | | | | |
Net unrealized gain (loss) on derivatives, net of reclassifications | 84 | | | (137) | | | 324 | | | (153) | |
Net unrealized loss on investments, net of reclassifications | — | | | — | | | — | | | (18) | |
Benefit plan net gain and prior service credit, net of amortization | 38 | | | 62 | | | 1,522 | | | 161 | |
Cumulative translation adjustment | (84) | | | 85 | | | (251) | | | (180) | |
| 38 | | | 10 | | | 1,595 | | | (190) | |
Comprehensive Income Attributable to Merck & Co., Inc. | $ | 4,605 | | | $ | 2,951 | | | $ | 10,886 | | | $ | 8,971 | |
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Net Income Attributable to Merck & Co., Inc. | $ | 3,248 | | | $ | 4,567 | | | $ | 11,502 | | | $ | 9,291 | |
Other Comprehensive (Loss) Income Net of Taxes: | | | | | | | |
Net unrealized gain on derivatives, net of reclassifications | 338 | | | 84 | | | 584 | | | 324 | |
Benefit plan net (loss) gain and prior service (cost) credit, net of amortization | (186) | | | 38 | | | 92 | | | 1,522 | |
Cumulative translation adjustment | (568) | | | (84) | | | (990) | | | (251) | |
| (416) | | | 38 | | | (314) | | | 1,595 | |
Comprehensive Income Attributable to Merck & Co., Inc. | $ | 2,832 | | | $ | 4,605 | | | $ | 11,188 | | | $ | 10,886 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
MERCK & CO., INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEET
(Unaudited, $ in millions except per share amounts)
| | | September 30, 2021 | | December 31, 2020 | | September 30, 2022 | | December 31, 2021 |
Assets | Assets | | Assets | |
Current Assets | Current Assets | | Current Assets | |
Cash and cash equivalents | Cash and cash equivalents | $ | 10,016 | | | $ | 8,050 | | Cash and cash equivalents | $ | 11,145 | | | $ | 8,096 | |
Accounts receivable (net of allowance for doubtful accounts of $69 in 2021 and $67 in 2020) | 8,571 | | | 6,803 | | |
Inventories (excludes inventories of $2,373 in 2021 and $2,070 in 2020 classified in Other assets - see Note 7) | 5,603 | | | 5,554 | | |
Short-term investments | | Short-term investments | 103 | | | — | |
Accounts receivable (net of allowance for doubtful accounts of $77 in 2022 and $62 in 2021) | | Accounts receivable (net of allowance for doubtful accounts of $77 in 2022 and $62 in 2021) | 9,482 | | | 9,230 | |
Inventories (excludes inventories of $2,641 in 2022 and $2,194 in 2021 classified in Other assets - see Note 7) | | Inventories (excludes inventories of $2,641 in 2022 and $2,194 in 2021 classified in Other assets - see Note 7) | 5,614 | | | 5,953 | |
Other current assets | Other current assets | 6,868 | | | 4,674 | | Other current assets | 7,217 | | | 6,987 | |
Current assets of discontinued operations | — | | | 2,683 | | |
Total current assets | Total current assets | 31,058 | | | 27,764 | | Total current assets | 33,561 | | | 30,266 | |
Investments | Investments | 435 | | | 785 | | Investments | 984 | | | 370 | |
Property, Plant and Equipment, at cost, net of accumulated depreciation of $18,155 in 2021 and $18,162 in 2020 | 18,565 | | | 17,000 | | |
Property, Plant and Equipment, at cost, net of accumulated depreciation of $17,921 in 2022 and $18,192 in 2021 | | Property, Plant and Equipment, at cost, net of accumulated depreciation of $17,921 in 2022 and $18,192 in 2021 | 20,424 | | | 19,279 | |
Goodwill | Goodwill | 18,862 | | | 18,882 | | Goodwill | 21,160 | | | 21,264 | |
Other Intangibles, Net | Other Intangibles, Net | 13,384 | | | 14,101 | | Other Intangibles, Net | 21,368 | | | 22,933 | |
Other Assets | Other Assets | 11,190 | | | 9,881 | | Other Assets | 9,584 | | | 11,582 | |
Noncurrent Assets of Discontinued Operations | — | | | 3,175 | | |
| | $ | 93,494 | | | $ | 91,588 | | | $ | 107,081 | | | $ | 105,694 | |
Liabilities and Equity | Liabilities and Equity | | Liabilities and Equity | |
Current Liabilities | Current Liabilities | | Current Liabilities | |
Loans payable and current portion of long-term debt | Loans payable and current portion of long-term debt | $ | 3,534 | | | $ | 6,431 | | Loans payable and current portion of long-term debt | $ | 1,936 | | | $ | 2,412 | |
Trade accounts payable | Trade accounts payable | 3,366 | | | 4,327 | | Trade accounts payable | 3,371 | | | 4,609 | |
Accrued and other current liabilities | Accrued and other current liabilities | 14,214 | | | 12,212 | | Accrued and other current liabilities | 14,222 | | | 13,859 | |
Income taxes payable | Income taxes payable | 954 | | | 1,597 | | Income taxes payable | 1,698 | | | 1,224 | |
Dividends payable | Dividends payable | 1,660 | | | 1,674 | | Dividends payable | 1,771 | | | 1,768 | |
Current liabilities of discontinued operations | — | | | 1,086 | | |
Total current liabilities | Total current liabilities | 23,728 | | | 27,327 | | Total current liabilities | 22,998 | | | 23,872 | |
Long-Term Debt | Long-Term Debt | 22,907 | | | 25,360 | | Long-Term Debt | 28,482 | | | 30,690 | |
Deferred Income Taxes | Deferred Income Taxes | 1,527 | | | 1,005 | | Deferred Income Taxes | 2,417 | | | 3,441 | |
Other Noncurrent Liabilities | Other Noncurrent Liabilities | 9,469 | | | 12,306 | | Other Noncurrent Liabilities | 8,660 | | | 9,434 | |
Noncurrent Liabilities of Discontinued Operations | — | | | 186 | | |
Merck & Co., Inc. Stockholders’ Equity | Merck & Co., Inc. Stockholders’ Equity | | Merck & Co., Inc. Stockholders’ Equity | |
Common stock, $0.50 par value Authorized - 6,500,000,000 shares Issued - 3,577,103,522 shares in 2021 and 2020 | 1,788 | | | 1,788 | | |
Common stock, $0.50 par value Authorized - 6,500,000,000 shares Issued - 3,577,103,522 shares in 2022 and 2021 | | Common stock, $0.50 par value Authorized - 6,500,000,000 shares Issued - 3,577,103,522 shares in 2022 and 2021 | 1,788 | | | 1,788 | |
Other paid-in capital | Other paid-in capital | 44,149 | | | 39,588 | | Other paid-in capital | 44,243 | | | 44,238 | |
Retained earnings | Retained earnings | 51,691 | | | 47,362 | | Retained earnings | 59,928 | | | 53,696 | |
Accumulated other comprehensive loss | Accumulated other comprehensive loss | (4,590) | | | (6,634) | | Accumulated other comprehensive loss | (4,743) | | | (4,429) | |
| | 93,038 | | | 82,104 | | | 101,216 | | | 95,293 | |
Less treasury stock, at cost: 1,051,780,149 shares in 2021 and 1,046,877,695 shares in 2020 | 57,244 | | | 56,787 | | |
Less treasury stock, at cost: 1,043,697,097 shares in 2022 and 1,049,499,023 shares in 2021 | | Less treasury stock, at cost: 1,043,697,097 shares in 2022 and 1,049,499,023 shares in 2021 | 56,758 | | | 57,109 | |
Total Merck & Co., Inc. stockholders’ equity | Total Merck & Co., Inc. stockholders’ equity | 35,794 | | | 25,317 | | Total Merck & Co., Inc. stockholders’ equity | 44,458 | | | 38,184 | |
Noncontrolling Interests | Noncontrolling Interests | 69 | | | 87 | | Noncontrolling Interests | 66 | | | 73 | |
Total equity | Total equity | 35,863 | | | 25,404 | | Total equity | 44,524 | | | 38,257 | |
| | $ | 93,494 | | | $ | 91,588 | | | $ | 107,081 | | | $ | 105,694 | |
The accompanying notes are an integral part of this condensed consolidated financial statement.
MERCK & CO., INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited, $ in millions)
| | | Nine Months Ended September 30, | | Nine Months Ended September 30, |
| | 2021 | | 2020 | | 2022 | | 2021 |
Cash Flows from Operating Activities | | |
Cash Flows from Operating Activities of Continuing Operations | | Cash Flows from Operating Activities of Continuing Operations | |
Net income from continuing operations | Net income from continuing operations | $ | 8,534 | | | $ | 7,137 | | Net income from continuing operations | $ | 11,508 | | | $ | 8,534 | |
Adjustments to reconcile net income from continuing operations to net cash provided by operating activities: | | |
Adjustments to reconcile net income from continuing operations to net cash provided by operating activities of continuing operations: | | Adjustments to reconcile net income from continuing operations to net cash provided by operating activities of continuing operations: | |
Amortization | Amortization | 1,231 | | | 1,393 | | Amortization | 1,623 | | | 1,231 | |
Depreciation | Depreciation | 1,148 | | | 1,210 | | Depreciation | 1,394 | | | 1,148 | |
Intangible asset impairment charges | Intangible asset impairment charges | — | | | 35 | | Intangible asset impairment charges | 910 | | | — | |
Income from investments in equity securities, net | (1,535) | | | (964) | | |
Loss (income) from investments in equity securities, net | | Loss (income) from investments in equity securities, net | 1,361 | | | (1,535) | |
Charge for the acquisition of Pandion Therapeutics, Inc. | Charge for the acquisition of Pandion Therapeutics, Inc. | 1,556 | | | — | | Charge for the acquisition of Pandion Therapeutics, Inc. | — | | | 1,556 | |
Deferred income taxes | Deferred income taxes | 28 | | | 32 | | Deferred income taxes | (1,261) | | | 28 | |
Share-based compensation | Share-based compensation | 360 | | | 329 | | Share-based compensation | 396 | | | 360 | |
Other | Other | 499 | | | 519 | | Other | 1,169 | | | 499 | |
Net changes in assets and liabilities | Net changes in assets and liabilities | (3,794) | | | (5,484) | | Net changes in assets and liabilities | (2,435) | | | (3,794) | |
Net Cash Provided by Operating Activities from Continuing Operations | 8,027 | | | 4,207 | | |
Cash Flows from Investing Activities | | |
Net Cash Provided by Operating Activities of Continuing Operations | | Net Cash Provided by Operating Activities of Continuing Operations | 14,665 | | | 8,027 | |
Cash Flows from Investing Activities of Continuing Operations | | Cash Flows from Investing Activities of Continuing Operations | |
Capital expenditures | Capital expenditures | (3,240) | | | (2,998) | | Capital expenditures | (3,239) | | | (3,240) | |
Purchases of securities and other investments | Purchases of securities and other investments | (1) | | | (78) | | Purchases of securities and other investments | (710) | | | (1) | |
Proceeds from sales of securities and other investments | Proceeds from sales of securities and other investments | 497 | | | 1,894 | | Proceeds from sales of securities and other investments | 709 | | | 497 | |
Acquisition of Pandion Therapeutics, Inc. net of cash acquired | (1,554) | | | — | | |
Acquisition of ArQule, Inc., net of cash acquired | — | | | (2,545) | | |
Acquisition of Pandion Therapeutics, Inc., net of cash acquired | | Acquisition of Pandion Therapeutics, Inc., net of cash acquired | — | | | (1,554) | |
Other acquisitions, net of cash acquired | Other acquisitions, net of cash acquired | (89) | | | (907) | | Other acquisitions, net of cash acquired | (121) | | | (89) | |
Other | Other | 15 | | | 138 | | Other | 149 | | | 15 | |
Net Cash Used in Investing Activities from Continuing Operations | (4,372) | | | (4,496) | | |
Cash Flows from Financing Activities | | |
Net Cash Used in Investing Activities of Continuing Operations | | Net Cash Used in Investing Activities of Continuing Operations | (3,212) | | | (4,372) | |
Cash Flows from Financing Activities of Continuing Operations | | Cash Flows from Financing Activities of Continuing Operations | |
Net change in short-term borrowings | Net change in short-term borrowings | (3,983) | | | (311) | | Net change in short-term borrowings | — | | | (3,983) | |
Payments on debt | Payments on debt | (1,153) | | | (1,954) | | Payments on debt | (2,250) | | | (1,153) | |
Distribution from Organon & Co. | Distribution from Organon & Co. | 9,000 | | | — | | Distribution from Organon & Co. | — | | | 9,000 | |
Proceeds from issuance of debt | — | | | 4,419 | | |
Purchases of treasury stock | Purchases of treasury stock | (822) | | | (1,281) | | Purchases of treasury stock | — | | | (822) | |
Dividends paid to stockholders | Dividends paid to stockholders | (4,967) | | | (4,673) | | Dividends paid to stockholders | (5,262) | | | (4,967) | |
Proceeds from exercise of stock options | Proceeds from exercise of stock options | 68 | | | 68 | | Proceeds from exercise of stock options | 119 | | | 68 | |
Other | Other | (253) | | | (472) | | Other | (172) | | | (253) | |
Net Cash Used in Financing Activities from Continuing Operations | (2,110) | | | (4,204) | | |
Discontinued Operations | | |
Net Cash Used in Financing Activities of Continuing Operations | | Net Cash Used in Financing Activities of Continuing Operations | (7,565) | | | (2,110) | |
Cash Flows from Discontinued Operations | | Cash Flows from Discontinued Operations | |
Net cash provided by operating activities | Net cash provided by operating activities | 1,051 | | | 2,040 | | Net cash provided by operating activities | — | | | 1,051 | |
Net cash used in investing activities | Net cash used in investing activities | (134) | | | (169) | | Net cash used in investing activities | — | | | (134) | |
Net cash used in financing activities | Net cash used in financing activities | (504) | | | — | | Net cash used in financing activities | — | | | (504) | |
Net Cash Flows Provided by Discontinued Operations | Net Cash Flows Provided by Discontinued Operations | 413 | | | 1,871 | | Net Cash Flows Provided by Discontinued Operations | — | | | 413 | |
Effect of Exchange Rate Changes on Cash, Cash Equivalents and Restricted Cash | Effect of Exchange Rate Changes on Cash, Cash Equivalents and Restricted Cash | (65) | | | 89 | | Effect of Exchange Rate Changes on Cash, Cash Equivalents and Restricted Cash | (776) | | | (65) | |
Net Increase (Decrease) in Cash, Cash Equivalents and Restricted Cash | 1,893 | | | (2,533) | | |
Cash, Cash Equivalents and Restricted Cash at Beginning of Year (includes restricted cash of $103 at January 1, 2021 included in Other Assets) | 8,153 | | | 9,934 | | |
Cash, Cash Equivalents and Restricted Cash at End of Period (includes restricted cash of $30 at September 30, 2021 included in Other Assets) | $ | 10,046 | | | $ | 7,401 | | |
Net Increase in Cash, Cash Equivalents and Restricted Cash | | Net Increase in Cash, Cash Equivalents and Restricted Cash | 3,112 | | | 1,893 | |
Cash, Cash Equivalents and Restricted Cash at Beginning of Year (includes restricted cash of $71 and $103 at January 1, 2022 and 2021, respectively, included in Other current assets) | | Cash, Cash Equivalents and Restricted Cash at Beginning of Year (includes restricted cash of $71 and $103 at January 1, 2022 and 2021, respectively, included in Other current assets) | 8,167 | | | 8,153 | |
Cash, Cash Equivalents and Restricted Cash at End of Period (includes restricted cash of $134 and $30 at September 30, 2022 and 2021, respectively, included in Other current assets) | | Cash, Cash Equivalents and Restricted Cash at End of Period (includes restricted cash of $134 and $30 at September 30, 2022 and 2021, respectively, included in Other current assets) | $ | 11,279 | | | $ | 10,046 | |
The accompanying notes are an integral part of this condensed consolidated financial statement.
Notes to Condensed Consolidated Financial Statements (unaudited)
1.Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of Merck & Co., Inc. (Merck or the Company) 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 (U.S.) (GAAP) 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’s Form 10-K filed on February 25, 2021.2022.
The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. In the Company’s opinion, all adjustments necessary for a fair statement of these interim statements have been included and are of a normal and recurring nature.
Reclassifications — Certain reclassifications have been made to prior year amounts to conform to the current year presentation.
Spin-Off of Organon & Co.
On June 2, 2021, Merck completed the spin-off of products from its women’s health, biosimilars and established brands businesses into a new, independent, publicly traded company named Organon & Co. (Organon) through a distribution of Organon’s publicly traded stock to Company shareholders. The distribution is expected to qualify and has been treated as tax-free to the Company and its shareholders for U.S. federal income tax purposes. The established brands included in the transaction consisted of dermatology, non-opioid pain management, respiratory, select cardiovascular products, as well as the rest of Merck’s diversified brands franchise. Merck’s existing research pipeline programs continue to be owned and developed within Merck as planned. The historical results of the women’s health, biosimilars and established brands businesses that were contributed to Organon in the spin-off have been reflected as discontinued operations in the Company’s consolidated financial statements through the date of the spin-off (see Note 2).
Recently Adopted Accounting Standards
In December 2019,August 2020, the Financial Accounting Standards Board (FASB) issued amended guidance on the accounting and reporting of income taxes. The guidance is intended to simplify the accounting for income taxes by removing exceptions related to certain intraperiod tax allocations and deferred tax liabilities, clarifying guidance primarily related to evaluating the step-up tax basis for goodwill in a business combination, and reflecting enacted changes in tax laws or rates in the annual effective tax rate. The Company adopted the new guidance effective January 1, 2021. There was no impact to the Company’s consolidated financial statements upon adoption.
In January 2020, the FASB issued new guidance intended to clarify certain interactions between accounting standards related to equity securities, equity method investments and certain derivatives. The guidance addresses accounting for the transition into and out of the equity method of accounting and measuring certain purchased options and forward contracts to acquire investments. The Company adopted the new guidance effective January 1, 2021. There was no impact to the Company’s consolidated financial statements upon adoption.
Recently Issued Accounting Standards Not Yet Adopted
In March 2020, the FASB issued optional guidance to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting and subsequently issued clarifying amendments. The guidance provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions that reference the London Interbank Offered Rate (LIBOR) or another reference rate expected to be discontinued because of reference rate reform. The optional guidance is effective upon issuance and can be applied on a prospective basis at any time between January 1, 2020 through December 31, 2022. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In August 2020, the FASB issued amended guidance on the accounting for convertible instruments and contracts in an entity’s own equity. The guidance removes the separation model for convertible debt instruments and preferred stock, amends requirements for conversion options to be classified in equity as well as amends diluted earnings per share (EPS) calculations for certain convertible debt instruments. The amended guidance is effective for interim and annual periods in 2022. Early adoption is permitted. The application of the amendments inCompany adopted the new guidance are to be applied either on January 1, 2022 using a modified retrospective approach. There was no impact to the Company’s consolidated financial statements upon adoption.
In November 2021, the FASB issued new guidance to increase the transparency of transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. The guidance requires annual disclosures of such transactions to include the nature of the transactions and the significant terms and conditions, the accounting treatment and the impact to a retrospective basis.company’s financial statements. The Company is currently evaluatingadopted the new guidance on January 1, 2022 on a prospective basis. There was no material impact of adoption on itsto the Company’s consolidated financial statements.statements upon adoption.
In March 2020, the FASB issued optional guidance to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting and subsequently issued clarifying amendments. The guidance provides optional expedients and exceptions for accounting for contracts, hedging relationships, and other transactions that reference the London Interbank Offered Rate (LIBOR) or another reference rate expected to be discontinued because of reference rate reform. The Company adopted the optional guidance on July 1, 2022 on a prospective basis. There was no material impact to the Company’s consolidated financial statements upon adoption.
Recently Issued Accounting Standards Not Yet Adopted
In October 2021, the FASB issued amended guidance that requires acquiring entities to recognize and measure contract assets and liabilities in a business combination in accordance with existing revenue recognition guidance. The amended guidance is effective for interim and annual periods in 2023 and is to be applied prospectively. Early adoption is permitted on a retrospective basis to the beginning of the fiscal year of adoption. The adoption of this guidance will not have an impact on the Company’s consolidated financial statements for prior acquisitions; however, the impact in future periods will be dependent upon the contract assets and contract liabilities acquired in future business combinations.
In June 2022, the FASB issued guidance related to the fair value measurement of an equity security subject to contractual restrictions that prohibit the sale of the equity security. The new guidance also introduces new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. The amended guidance is effective for interim and annual periods in 2024 and is to be applied prospectively. Early adoption is permitted for both interim and annual periods. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
Notes to Condensed Consolidated Financial Statements (unaudited)
2. Spin-Off of Organon & Co.
On June 2, 2021, Merck completed the spin-off of Organon through a distribution of Organon’s publicly traded stock to Company shareholders. In connection with the spin-off, each Merck shareholder received one tenth of a share of Organon’s common stock for each share of Merck common stock held by such shareholder. The distribution is expected to qualify and has been treated as tax free to Merck and its shareholders for U.S. federal income tax purposes. Indebtedness of $9.5 billion principal amount, consisting of term loans and senior notes, was issued in 2021 in connection with the spin-off and assumed by Organon. Merck is no longer the obligor of any Organon debt or financing arrangements. Cash proceeds of $9.0 billion were distributed by Organon to Merck in connection with the spin-off.
Also in connection with the spin-off, Merck and Organon entered into a separation and distribution agreement and also entered into various other agreements to effect the spin-off and provide a framework for the relationship between Merck and Organon after the spin-off, including a transition services agreement (TSA), manufacturing and supply agreements (MSAs), trademark license agreements, intellectual property license agreements, an employee matters agreement, a tax matters agreement and certain other commercial agreements. Under the TSA, Merck will provideis providing Organon various services and, similarly, Organon will provideis providing Merck various services. The provision of services under the TSA agreement generally will terminate within 25 months following the spin-off.spin-off; however, the provision of certain services has been extended to 31 months. Merck and Organon also entered into a series of interim operating agreements pursuant to which in various jurisdictions where Merck held licenses, permits and other rights in connection with marketing, import and/or distribution of Organon products prior to the separation, Merck will continueis continuing to market, import and distribute such products until such time as the relevant licenses and permits are transferred to Organon. Under such interim operating agreements and in accordance with the separation and distribution agreement, Merck will continueis continuing operations in the affected markets on behalf of Organon, with Organon receiving all of the economic benefits and burdens of such activities. Additionally, Merck and Organon entered into a number of MSAs pursuant to which Merck willis (a) manufacturemanufacturing and supplysupplying certain active pharmaceutical ingredients for Organon, (b) toll manufacturemanufacturing and supplysupplying certain formulated pharmaceutical products for Organon, and (c) packagepackaging and labellabeling certain finished pharmaceutical products for Organon. Similarly, Organon and Merck entered into a number of MSAs pursuant to which Organon willis (a) manufacturemanufacturing and supplysupplying certain formulated pharmaceutical products for Merck, and (b) packagepackaging and labellabeling certain finished pharmaceutical products for Merck. The terms of the MSAs range in initial duration from four years to ten years.
The amounts included in the condensed consolidated statement of income for the above MSAs include sales of $100 million and $293 million and related cost of sales of $104 million and $312 million for the three and nine months ended September 30, 2022, respectively. The amounts included in the condensed consolidated statement of income for the MSAs in the same periods of 2021 were immaterial. Amounts included in the condensed consolidated statement of income for the above agreementsTSAs were immaterial infor the third quarterthree and first nine months ofended September 30, 2022 and September 30, 2021.
The amountamounts due from Organon under all of the above agreements was $1.4 billionwere $567 million and $964 million at September 30, 2022 and December 31, 2021, respectively, and isare reflected in Other current assets. The amountamounts due to Organon under these agreements was $930were $333 million and $400 million at September 30, 2022 and December 31, 2021, respectively, and isare included in AccruedAccrued and other current liabilities.
The results of the women’s health, biosimilars and established brands businesses (previously included in the Pharmaceutical segment) that were contributed to Organon in the spin-off, as well as interest expense related to the debt issuance in 2021, have been reflected as discontinued operations in the Company’s condensed consolidated statement of income as Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests throughfor periods prior to the spin-off on June 2, 2021, the date of the spin-off. Prior periods have been recast to reflect this presentation. As a result of the spin-off of Organon,2021. Merck incurred separation costs of $556 million infor the nine months ended September 30, 2021 and $193 million and $483 million inrelated to the three and nine months ended September 30, 2020, respectively,spin-off of Organon, which are also included in Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests. These costs primarily relate to professional fees for separation activities within finance, tax, legal and information technology functions, as well as investment banking fees. As of December 31, 2020, the assets and liabilities associated with these businesses are classified as assets and liabilities of discontinued operations in the condensed consolidated balance sheet.
Notes to Condensed Consolidated Financial Statements (unaudited)
Details of Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests are as follows:
| | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | | | 2020 | | 2021 (1) | | 2020 |
Sales | | | $ | 1,622 | | | $ | 2,512 | | | $ | 4,911 | |
Costs, Expenses and Other | | | | | | | |
Cost of sales | | | 468 | | | 789 | | | 1,362 | |
Selling, general and administrative | | | 390 | | | 877 | | | 1,046 | |
Research and development | | | 41 | | | 103 | | | 113 | |
Restructuring costs | | | 1 | | | 1 | | | 4 | |
Other (income) expense, net | | | — | | | (15) | | | 7 | |
| | | 900 | | | 1,755 | | | 2,532 | |
Income from discontinued operations before taxes | | | 722 | | | 757 | | | 2,379 | |
Tax provision (benefit) | | | 103 | | | (12) | | | 343 | |
Income from discontinued operations, net of taxes | | | 619 | | | 769 | | | 2,036 | |
Less: Income of discontinued operations attributable to noncontrolling interests | | | 2 | | | 3 | | | 11 | |
Income from discontinued operations, net of taxes and amounts attributable to noncontrolling interests | | | $ | 617 | | | $ | 766 | | | $ | 2,025 | |
(1)Reflects amounts through the June 2, 2021 spin-off date.
Details of assets and liabilities of discontinued operations are as follows:
| | | | | | | | |
| | Nine Months Ended September 30, |
($ in millions) | | December 31, 20202021 (1)
|
Cash and cash equivalentsSales | | $ | 122,512 | |
Accounts receivable, less allowance for doubtful accountsCosts, Expenses and Other | | |
Cost of sales | | 1,048789 | |
InventoriesSelling, general and administrative | | 756877 | |
Research and development | | 103 | |
Restructuring costs | | 1 | |
Other current assets(income) expense, net | | 867 | |
Current assets of discontinued operations | | $ | 2,683 (15) | |
| | |
Property, plant and equipment, net | | $ | 9861,755 | |
GoodwillIncome from discontinued operations before taxes | | 1,356757 | |
Other intangibles, netIncome tax benefit | | 503 (12) | |
Other assetsIncome from discontinued operations, net of taxes | | 330769 | |
Noncurrent AssetsLess: Income of Discontinued Operationsdiscontinued operations attributable to noncontrolling interests | | $ | 3,1753 | |
| | |
Trade accounts payable | | $ | 267 | |
Accrued and other current liabilities | | 841 | |
Income taxes payable | | (22) | |
Total current liabilities of discontinued operations | | $ | 1,086 | |
| | |
Deferred income taxes | | $ | 10 | |
Other noncurrent liabilities | | 176 | |
Noncurrent Liabilities of Discontinued Operations | | $ | 186766 | |
As a result of(1) Reflects amounts through the spin-off of Organon, Merck distributed net liabilities of $5.1 billion as of June 2, 2021 consisting of debt of $9.4 billion (described above), goodwill of $1.4 billion, property, plant and equipment of $981 million, cash of $929 million, inventory of $815 million, other intangibles, net, of $519 million and other net liabilities of $328 million. The spin-off also resulted in a net decrease to date.Accumulated other comprehensive loss (AOCL) of $449 million consisting of $421 million for the derecognition of net losses on foreign currency translation adjustments and $28 million associated with employee benefit plans. The distribution of the net liabilities and reduction to AOCL resulted in a net $4.6 billion increase to Other paid-in capital.
Notes to Condensed Consolidated Financial Statements (unaudited)
The Company has share-based compensation plans under which the Company grants restricted stock units (RSUs) and performance share units (PSUs) to certain management level employees. In addition, employees and non-employee directors were granted options to purchase shares of Company common stock at the fair market value at the time of grant. In connection with the spin-off of Organon, all outstanding Merck stock options, RSUs and PSUs (whether vested or unvested) were converted into adjusted Merck awards for current and former Merck employees or Organon awards for Organon employees. Such adjusted awards preserved the same intrinsic value and general terms and conditions (including vesting) as were in place immediately prior to the adjustments. Approximately 1.3 million RSUs, 1.9 million stock options and 248 thousand PSUs were converted from Merck awards into Organon awards.
Expenses for curtailments, settlements and termination benefits provided to certain employees were incurred in connection with the spin-off. Additionally, the transfer of employees to Organon triggered remeasurements of some of the Company’s pension plans (see Note 11).
3. Acquisitions, Research Collaborations and License Agreements
The Company continues to pursue acquisitions and the establishment of external alliances such as research collaborations and licensing agreements to complement its internal research capabilities. These arrangements often include upfront payments, as well as expense reimbursements or payments to the third party, and milestone, royalty or profit share arrangements, contingent upon the occurrence of certain future events linked to the success of the asset in development. The Company also reviews its marketed products and pipeline to examine candidates which may provide more value through out-licensing and, as part of its portfolio assessment process, may also divest certain assets. Pro forma financial information for acquired businesses is not presented if the historical financial results of the acquired entity are not significant when compared with the Company’s financial results.
2022 Transactions
In September 2021,October 2022, Merck and AcceleronRoyalty Pharma Inc. (Acceleron), a publicly traded biopharmaceutical company,plc (Royalty Pharma) entered into a definitive agreementfunding arrangement under which Royalty Pharma paid Merck will acquire Acceleron$50 million to co-fund Merck’s development costs for $180 per share in cash fora Phase 2b trial of MK-8189, an approximate total equity value of $11.5 billion. Acceleroninvestigational oral Phosphodiesterase 10A (PDE10A) inhibitor, which is focused on harnessing the power of the transforming growth factor (TGF)-beta superfamily of proteins that is known to play a central role in the regulation of cell growth, differentiation and repair. Acceleron’s lead therapeutic candidate, sotatercept, has a novel mechanism of action with the potential to improve short-term and/or long-term clinical outcomes in patients with pulmonary arterial hypertension (PAH). Sotatercept is in Phase 3 trials as add-on to current standard of carebeing evaluated for the treatment of PAH. schizophrenia. Under the agreement, Royalty Pharma has no rights to MK-8189 and has no decision-making authority over the program. If Merck elects to advance MK-8189 into a Phase 3 study, Royalty Pharma has the option to provide additional funding of 50% of the development costs up to $375 million for the Phase 3 trial. If such additional funding is provided, Royalty Pharma becomes eligible to receive future regulatory milestone payments contingent upon certain marketing approvals, as well as royalties.
In additionSeptember 2022, Merck exercised its option to sotatercept, Acceleron’s portfolio includes Reblozyl (luspatercept-aamt)jointly develop and commercialize personalized cancer vaccine mRNA-4157/V940 pursuant to the terms of an existing collaboration and license agreement with Moderna, Inc. (Moderna), which resulted in a $250 million charge in Research and development expenses in the third quarter and first nine months of 2022. The payment to Moderna was made in the fourth quarter of 2022. mRNA-4157/V940 is currently being evaluated in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma in a Phase 2 clinical trial being conducted by Moderna. Under the 2016 agreement, as amended in 2018, Merck and Moderna will collaborate on development and commercialization and will share costs and any profits equally under this worldwide collaboration.
In August 2022, Merck and Orna Therapeutics (Orna), a first-in-class erythroid maturation recombinant fusion protein approvedbiotechnology company pioneering a new investigational class of engineered circular RNA (oRNA) therapies, entered into a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the U.S., Europe, Canadaareas of infectious disease and Australia for the treatment of anemia in certain rare blood disorders. Reblozyl is being developed and commercialized through a global collaboration with Bristol Myers Squibb.oncology. Under the terms of the acquisition agreement, Merck through a subsidiary, initiated a tender offermade an upfront payment to acquire all outstanding sharesOrna of Acceleron. The closing$150 million, which was recorded in Research and development expenses in the third quarter and first nine months of 2022. In addition, Orna is eligible to receive future contingent development-related payments aggregating up to $440 million, $675 million in regulatory milestones, and $2.4 billion in sales milestones associated with the progress of the tender offer is subjectmultiple vaccine and therapeutic programs, as well as royalties
Notes to certain conditions, including the tender of shares representing at leastCondensed Consolidated Financial Statements (unaudited) (continued)
ranging from a majority of the total number of Acceleron’s outstanding shares, receipt of applicable regulatory approvals, and other customary conditions. The acquisition agreement includes termination provisions providing that (i) in the event Acceleron terminates in order to enter into an agreement with respecthigh-single-digit rate to a superior proposal (as definedlow-double-digit rate on any approved products derived from the collaboration. Merck also invested $100 million in the agreement), Acceleron will be required to pay a termination fee of $345 million, and (ii) in the event the acquisition is not consummated due to antitrust conditions, Merck will be required to pay Acceleron a reverse termination fee of $650 million to $750 million depending on the time of termination. The transaction is expected to closeOrna’s Series B preferred shares in the fourth quarter of 2021.2022.
In July 2022, Merck and Orion Corporation (Orion) announced a global co-development and co-commercialization agreement for Orion’s investigational candidate ODM-208 (MK-5684) and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production. ODM-208 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer. Merck made an upfront payment to Orion of $290 million, which was recorded in Research and development expenses in the third quarter and first nine months of 2022. Orion is responsible for the manufacture of clinical and commercial supply of ODM-208. In addition, the contract provides both parties with an option to convert the initial co-development and co-commercialization agreement into a global exclusive license to Merck. If the option is exercised, Merck would assume full responsibility for all past development and commercialization expenses associated with the program since inception of the agreement, as well as all future development and commercialization expenses. In addition, Orion would be eligible to receive milestone payments associated with progress in the development and commercialization of ODM-208 as well as tiered double-digit royalties on sales if the product is approved.
Also in July 2022, Merck and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) closed a license and collaboration agreement in which Merck gained exclusive worldwide rights for the development, manufacture and commercialization of an investigational antibody drug conjugate (ADC) (MK-1200) for the treatment of solid tumors. Under the terms of the agreement, Merck and Kelun-Biotech will collaborate on the early clinical development of the investigational ADC. Merck made an upfront payment of $35 million, which was recorded in Research and development expenses in the third quarter and first nine months of 2022. Kelun-Biotech is also eligible to receive future contingent milestone payments aggregating up to $82 million in developmental milestones, $334 million in regulatory milestones, and $485 million in sales-based milestones. The agreement also provides for Merck to pay tiered royalties ranging from a mid-single-digit rate to a low-double-digit rate on future net sales.
In May 2022, in connection with an existing arrangement, Merck exercised its option to obtain an exclusive license outside of China for the development, manufacture and commercialization of Kelun-Biotech’s trophoblast antigen 2 (TROP2)-targeting ADC programs, including its lead compound, SKB-264 (MK-2870). SKB-264 is currently being evaluated in Phase 2 trials for non-small-cell lung cancer and advanced solid tumors. Under the terms of the agreement, Merck and Kelun-Biotech will collaborate on certain early clinical development plans, including evaluating the potential of SKB-264 as a monotherapy and in combination with Keytruda for advanced solid tumors. Upon option exercise, Merck made a payment of $30 million, which was recorded in Research and development expenses in the first nine months of 2022, and agreed to make additional payments of $30 million upon completion of specified project activities and $25 million upon technology transfer. Merck also agreed to make quarterly payments in 2022 and 2023 aggregating up to $101 million to fund Kelun-Biotech’s ongoing research and development activities. In addition, Kelun-Biotech is eligible to receive future contingent milestone payments (which includes all program compounds) aggregating up to $90 million in developmental milestones, $290 million in first commercial sale milestones, and $780 million in sales-based milestones. The agreement also provides for Merck to pay tiered royalties ranging from a mid-single-digit rate to a low-double-digit rate on future net sales.
2021 Transactions
In April 2021, Merck acquired Pandion Therapeutics, Inc. (Pandion), a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases. Pandion is advancing a pipeline of precision immune modulators targeting critical immune control nodes. Total consideration paid of $1.9 billion included $147 million of transaction costs primarily comprised of share-based compensation payments to settle equity awards. The transaction was accounted for as an acquisition of an asset. Merck recorded net assets of $156 million (primarily cash) and Research and development expenses of $1.7 billion in the first nine months of 2021 related to the transaction. There are no future contingent payments associated with the acquisition.
In March 2021, Merck and Gilead Sciences, Inc. (Gilead) entered into an agreement to jointly develop and commercialize long-acting treatments in HIV that combine Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, and Gilead’s investigational capsid inhibitor, lenacapavir. The collaboration will initially focus on long-acting oral formulations and long-acting injectable formulations of these combination products, with other formulations potentially added to the collaboration as mutually agreed. There was no upfront payment made by either party upon entering into the agreement.
Under the terms of the agreement, Gilead and Merck will share operational responsibilities, as well as development, commercialization and marketing costs, and any future revenues. Global development and commercialization costs will be shared 60% Gilead and 40% Merck across the oral and injectable formulation programs. For long-acting oral products, Gilead
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
will lead commercialization in the U.S. and Merck will lead commercialization in the EU and the rest of the world. For long-acting injectable products, Merck will lead commercialization in the U.S. and Gilead will lead commercialization in the EU and the rest of the world. Gilead and Merck will co-promote in the U.S. and certain other major markets. Merck and Gilead will share global product revenues equally until product revenues surpass certain pre-agreed per formulation revenue tiers. Upon passing $2.0 billion a year in net product sales for the oral combination, the revenue split will adjust to 65% Gilead and 35% Merck for any revenues above the threshold. Upon passing $3.5 billion a year in net product sales for the injectable combination, the revenue split will adjust to 65% Gilead and 35% Merck for any revenues above the threshold.
Beyond the potential combinations of investigational lenacapavir and investigational islatravir, Gilead will have the option to license certain of Merck’s investigational oral integrase inhibitors to develop in combination with lenacapavir. Reciprocally, Merck will have the option to license certain of Gilead’s investigational oral integrase inhibitors to develop in combination with islatravir. Each company may exercise its option for an investigational oral integrase inhibitor of the other company following completion of the first Phase 1 clinical trial of that integrase inhibitor. Upon exercise of an option, the companies will split development costs and revenues, unless the non-exercising company decides to opt-out.
In January 2021, Merck entered into an exclusive license and research collaboration agreement with Artiva Biotherapeutics, Inc. (Artiva) to discover, develop and manufacture CAR-NK cells that target certain solid tumors using Artiva’s proprietary platform. Merck and Artiva agreed to engage in up to three different research programs, each covering a collaboration target. Merck has sole responsibility for all development and commercialization activities (including regulatory filing and approval). Under the terms of the agreement, Merck made an upfront payment of $30 million, which was included in Research and development expenses in the first nine months of 2021, for license and other rights for the first two collaboration targets and agreed to make another upfront payment of $15 million for license and other rights for the third collaboration target when it is selected by Merck and accepted by Artiva. In addition, Artiva is eligible to receive future contingent milestone payments (which span all three collaboration targets), aggregating up to:to $217.5 million in developmental milestones, $570 million in regulatory milestones, and $1.05 billion in sales-based milestones. The agreement also provides for Merck to pay tiered royalties ranging from 7% to 14% on future sales.
In DecemberNotes to Condensed Consolidated Financial Statements (unaudited) (continued)
As part of Merck’s 2020 acquisition of OncoImmune, Merck acquired OncoImmune,obtained MK-7110, a privately held, clinical-stage biopharmaceutical company, for an upfront payment of $423 million. OncoImmune’s lead therapeutic candidate MK-7110 (formerly known as CD24Fc)that was being evaluated for the treatment of patients hospitalized with coronavirus disease 2019 (COVID-19). The transaction was accounted for as an acquisition of an asset. Under the agreement, prior to the completion of the acquisition, OncoImmune spun-out certain rights and assets unrelated to the MK-7110 program to a new entity owned by the existing shareholders of OncoImmune. In connection with the closing of the acquisition, Merck invested $50 million for a 20% ownership interest in the new entity, which was valued at $33 million resulting in a $17 million premium. Merck also recognized other net liabilities of $22 million. The Company recorded Research and development expenses of $462 million in 2020 related to this transaction.COVID-19. In 2021, Merck received feedback from the U.S. Food and Drug Administration (FDA) that additional data would be needed to support a potential Emergency Use Authorization application and therefore the Company did not expect MK-7110 would become available until the first half of 2022. Given this timeline and the technical, clinical and regulatory uncertainties, the availability of a number of medicines for patients hospitalized with COVID-19, and the need to concentrate Merck’s resources on accelerating the development and manufacture of the most viable therapeutics and vaccines, Merck decided to discontinue development of MK-7110 for the treatment of COVID-19. Due to the discontinuation, the Company recorded charges of $207 million in the first nine months of 2021, which are reflected in Cost of sales and relate to fixed-assetfixed assets and materials write-offs,written off, as well as the recognition of liabilities for purchase commitments.
In September 2020, Merck and Seagen Inc. (Seagen, formerly known as Seattle Genetics, Inc.) announced an oncology collaboration to globally develop and commercialize Seagen’s ladiratuzumab vedotin (MK-6440), an investigational antibody-drug conjugate targeting LIV-1, which is currently in Phase 2 clinical trials. The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Keytruda (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors. The companies will equally share profits worldwide. Under the terms of the agreement, Merck made an upfront payment of $600 million and a $1.0 billion equity investment in 5 million shares of Seagen common stock at a price of $200 per share. Merck recorded $622 million in Research and development expenses in the third quarter and first nine months of 2020 related to this transaction reflecting the upfront payment as well as a $22 million mark-to-market loss on the purchase commitment (forward contract) relating to the equity shares (calculated based on the closing price of Seagen common stock on September 30, 2020). The closing of the equity investment occurred in October 2020 and resulted in the recognition of a $6 million reduction to Research and development expenses based on the price of Seagen common stock on the closing date. Seagen is also eligible to receive future contingent milestone payments of up to $2.6 billion, including $850 million in development milestones and $1.75 billion in sales-based milestones.
Concurrent with the above transaction, Seagen granted Merck an exclusive license to commercialize Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor, for the treatment of human epidermal growth factor receptor 2 (HER2)-
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Merck will be responsible for marketing applications seeking approval in its territories, supported by the positive results from the HER2CLIMB clinical trial. Merck will also co-fund a portion of the Tukysa global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers set forth in a global product development plan. Merck will solely fund and conduct country-specific clinical trials necessary to support anticipated regulatory applications in its territories. Under the terms of the agreement, Merck made upfront payments aggregating $210 million, which were recorded as Research and development expenses in the third quarter and first nine months of 2020. Seagen is also eligible to receive future contingent regulatory approval milestones of up to $65 million and will receive tiered royalties ranging from 20% to 33% based on annual sales levels of Tukysa in Merck’s territories.
Additionally in September 2020, Merck acquired a biologics manufacturing facility located in Dunboyne, Ireland from Takeda Pharmaceutical Company Limited for €256 million ($302 million). The transaction was accounted for as an acquisition of an asset. Merck recorded property, plant and equipment of $289 million and other net assets of $13 million. There are no future contingent payments associated with the acquisition.
In July 2020, Merck acquired the U.S. rights to Sentinel Flavor Tabs and Sentinel Spectrum Chews from Virbac Corporation for $410 million. Sentinel products provide protection against common parasites in dogs. The transaction was accounted for as an acquisition of an asset. Merck recognized intangible assets of $401 million related to currently marketed products and inventory of $9 million at the acquisition date. The estimated fair values of the identifiable intangible assets related to currently marketed products were determined using an income approach. Actual cash flows are likely to be different than those assumed. The intangible assets related to currently marketed products will be amortized over their estimated useful lives of 15 years. There are no future contingent payments associated with the acquisition.
Also in July 2020, Merck and Ridgeback Biotherapeutics LP (Ridgeback Bio), a closely held biotechnology company, closed a collaboration agreement to develop molnupiravir (MK-4482/EIDD-2801) an orally available antiviral candidate in clinical development for the treatment of patients with COVID-19. Merck gained exclusive worldwide rights to develop and commercialize molnupiravir and related molecules. Under the terms of the agreement, Ridgeback Bio received an upfront payment and is eligible to receive future contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Any profits from the collaboration will be split between the partners equally. Merck and Ridgeback Bio are committed to ensure that any medicines developed for SARS-CoV-2 (the causative agent of COVID-19) will be accessible and affordable globally.
In June 2020, Merck acquired privately held Themis Bioscience GmbH (Themis), a company focused on vaccines (including a COVID-19 vaccine candidate, V591) and immune-modulation therapies for infectious diseases and cancer for $366 million. The acquisition originally provided for Merck to make additional contingent payments of up to $740 million. The transaction was accounted for as an acquisition of a business. The Company determined the fair value of the contingent consideration was $85 million at the acquisition date utilizing a probability-weighted estimated cash flow stream using an appropriate discount rate dependent on the nature and timing of the milestone payments. Merck recognized intangible assets for in-process research and development (IPR&D) of $113 million, cash of $59 million, deferred tax assets of $72 million and other net liabilities of $32 million. The excess of the consideration transferred over the fair value of net assets acquired of $239 million was recorded as goodwill that was allocated to the Pharmaceutical segment and is not deductible for tax purposes. The fair values of the identifiable intangible assets related to IPR&D were determined using an income approach. Actual cash flows are likely to be different than those assumed. In January 2021, the Company announced it was discontinuing development of V591. As a result, in the fourth quarter of 2020, the Company recorded an IPR&D impairment charge of $90 million within Research and development expenses. The Company also recorded a reduction in Research and development expenses resulting from a decrease in the related liability for contingent consideration of $45 million since future contingent milestone payments have been reduced to $450 million in the aggregate, including up to $60 million for development milestones, up to $196 million for regulatory approval milestones, and up to $194 million for commercial milestones.
In January 2020, Merck acquired ArQule, Inc. (ArQule), a publicly traded biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of patients with cancer and other diseases. Total consideration paid of $2.7 billion included $138 million of share-based compensation payments to settle equity awards attributable to precombination service and cash paid for transaction costs on behalf of ArQule. The Company incurred $95 million of transaction costs directly related to the acquisition of ArQule, consisting almost entirely of share-based compensation payments to settle non-vested equity awards attributable to postcombination service. These costs were included in Selling, general and administrative expenses in the first nine months of 2020. ArQule’s lead investigational candidate, MK-1026 (formerly known as ARQ 531), is a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently being evaluated for the treatment of B-cell malignancies. The transaction was accounted for as an acquisition of a business.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
The estimated fair value of assets acquired and liabilities assumed from ArQule is as follows:
| | | | | |
| |
($ in millions) | January 16, 2020 |
Cash and cash equivalents | $ | 145 | |
IPR&D MK-1026 (formerly ARQ 531) (1)
| 2,280 | |
Licensing arrangement for ARQ 087 | 80 | |
Deferred income tax liabilities | (361) | |
Other assets and liabilities, net | 34 | |
Total identifiable net assets | 2,178 | |
Goodwill (2)
| 512 | |
Consideration transferred | $ | 2,690 | |
(1) The estimated fair value of the identifiable intangible asset related to IPR&D was determined using an income approach. The future net cash flows were discounted to present value utilizing a discount rate of 12.5%. Actual cash flows are likely to be different than those assumed.
(2) The goodwill was allocated to the Pharmaceutical segment and is not deductible for tax purposes.
4. Collaborative Arrangements
Merck has entered into collaborative arrangements that provide the Company with varying rights to develop, produce and market products together with its collaborative partners. Both parties in these arrangements are active participants and exposed to significant risks and rewards dependent on the commercial success of the activities of the collaboration. Merck’s more significant collaborative arrangements are discussed below. For further details refer to Note 4 to the consolidated financial statements included in Merck’s 2020 Form 10‑K.
AstraZeneca
In 2017, Merck and AstraZeneca PLC (AstraZeneca) entered into a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza (olaparib) for multiple cancer types. Independently, Merck and AstraZeneca will develop and commercialize Lynparza in combinations with their respective PD-1 and PD-L1 medicines, Keytruda and Imfinzi. The companies are also jointly developing and commercializing AstraZeneca’s Koselugo (selumetinib) for multiple indications. Under the terms of the agreement, AstraZeneca and Merck will share the development and commercialization costs for Lynparza and Koselugo monotherapy and non-PD-L1/PD-1 combination therapy opportunities.
Profits from Lynparza and Koselugo product sales generated through monotherapies or combination therapies are shared equally. AstraZeneca is the principal on Lynparza and Koselugo sales transactions. Merck records its share of Lynparza and Koselugo product sales, net of cost of sales and commercialization costs, as alliance revenue and its share of development costs associated with the collaboration as part of Research and development expenses. Reimbursements received from AstraZeneca for research and development expenses are recognized as reductions to Research and development costs.
As part of the agreement, Merck made an upfront payment to AstraZeneca and also made payments over a multi-year period for certain license options. In addition, the agreement provides for additional contingent payments from Merck to AstraZeneca related to the successful achievement of sales-based and regulatory milestones.
In the first quarter of 2022, Merck determined it was probable that sales of Lynparza in the future would trigger a $600 million sales-based milestone payment from Merck to AstraZeneca. Accordingly, Merck recorded a $600 million liability and a corresponding increase to the intangible asset related to Lynparza. Merck also recognized $250 million of cumulative amortization catch-up expense related to the recognition of this milestone in the first quarter of 2022. In the first nine months of 2022, Merck made a sales-based milestone payment to AstraZeneca (which had been previously accrued for) of $400 million. As of September 30, 2021,2022, sales-based milestone payments accrued but not yet paid totaled $400$600 million. Potential future sales-based milestone payments of $2.7$2.1 billion have not yet been accrued as they are not deemed by the Company to be probable at this time. Additionally, potentialIn the first nine months of 2022, Lynparza received regulatory approvals triggering capitalized milestone payments of $250 million from Merck to AstraZeneca. Potential future regulatory milestone payments of $1.4$1.2 billion remain under the agreement.
The intangible asset balance related to Lynparza (which includes capitalized sales-based and regulatory milestone payments) was $1.1$1.5 billion at September 30, 20212022 and is included in Other Intangibles, Net. The amount is being amortized over its estimated useful life through 2028 as supported by projected future cash flows, subject to impairment testing.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Summarized financial information related to this collaboration is as follows:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 |
Alliance revenue - Lynparza | Alliance revenue - Lynparza | $ | 246 | | | $ | 196 | | | $ | 721 | | | $ | 519 | | Alliance revenue - Lynparza | $ | 284 | | | $ | 246 | | | $ | 825 | | | $ | 721 | |
Alliance revenue - Koselugo | Alliance revenue - Koselugo | 6 | | | 3 | | | 20 | | | 3 | | Alliance revenue - Koselugo | 10 | | | 6 | | | 43 | | | 20 | |
Total alliance revenue | Total alliance revenue | $ | 252 | | | $ | 199 | | | $ | 741 | | | $ | 522 | | Total alliance revenue | $ | 294 | | | $ | 252 | | | $ | 868 | | | $ | 741 | |
| Cost of sales (1) | Cost of sales (1) | 42 | | | 41 | | | 125 | | | 205 | | Cost of sales (1) | 64 | | | 42 | | | 425 | | | 125 | |
Selling, general and administrative | Selling, general and administrative | 44 | | | 40 | | | 127 | | | 112 | | Selling, general and administrative | 45 | | | 44 | | | 135 | | | 127 | |
Research and development | Research and development | 27 | | | 20 | | | 87 | | | 93 | | Research and development | 28 | | | 27 | | | 79 | | | 87 | |
| ($ in millions) | ($ in millions) | | September 30, 2021 | | December 31, 2020 | ($ in millions) | | September 30, 2022 | | December 31, 2021 |
Receivables from AstraZeneca included in Other current assets | Receivables from AstraZeneca included in Other current assets | | $ | 248 | | | $ | 215 | | Receivables from AstraZeneca included in Other current assets | | $ | 290 | | | $ | 271 | |
Payables to AstraZeneca included in Accrued and other current liabilities (2) | | 415 | | | 423 | | |
Payables to AstraZeneca included in Trade accounts payable and Accrued and other current liabilities (2) | | Payables to AstraZeneca included in Trade accounts payable and Accrued and other current liabilities (2) | | 12 | | | 415 | |
Payables to AstraZeneca included in Other Noncurrent Liabilities (2) | | Payables to AstraZeneca included in Other Noncurrent Liabilities (2) | | 600 | | | — | |
(1) Represents amortization of capitalized milestone payments. Amount in the first nine months of 2022 includes $250 million of cumulative amortization catch-up expense as noted above.
(2) Includes accrued milestone payments.
Eisai
In 2018, Merck and Eisai Co., Ltd. (Eisai) announced a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima (lenvatinib), an orally available tyrosine kinase inhibitor discovered by Eisai. Under the agreement, Merck and Eisai will develop and commercialize Lenvima jointly, both as monotherapy and in combination with Keytruda. Eisai records Lenvima product sales globally (Eisai is the principal on Lenvima sales transactions), and Merck and Eisai share applicable profits equally. Merck records its share of Lenvima product sales, net of cost of sales and commercialization costs, as alliance revenue. Expenses incurred during co-development are shared by the two companies in accordance with the collaboration agreement and reflected in Research and development expenses. Certain expenses incurred solely by Merck or Eisai are not shareable under the collaboration agreement, including costs incurred in excess of agreed upon caps and costs related to certain combination studies of Keytruda and Lenvima.
Under the agreement, Merck made an upfront payment to Eisai and also made payments over a multi-year period for certain optionsoption rights (of which the final $125 million option payment was made in March 2021). In addition, the agreement provides for additional contingent payments from Merck to Eisai related to the successful achievement of sales-based and regulatory milestones.
In the first nine months of 2022, Merck made sales-based milestone payments of $200 million to Eisai in the first nine months of 2021. As of September 30, 2021, sales-based milestone payments(which had been previously accrued but not yet paid totaledfor) aggregating $600 million. Potential future sales-based milestone payments of $2.6 billion have not yet been accrued as they are not deemed by the Company to be probable at this time. In the third quarterfirst nine months of 2021,2022, Lenvima received a regulatory approvalapprovals triggering a capitalized milestone paymentpayments of $75$50 million from Merck to Eisai. Potential futureThere are no regulatory milestone payments of $50 million remainremaining under the agreement.
The intangible asset balance related to Lenvima (which includes capitalized sales-based and regulatory milestone payments) was $1.0 billion$867 million at September 30, 20212022 and is included in Other Intangibles, Net. The amount is being amortized over its estimated useful life through 2026 as supported by projected future cash flows, subject to impairment testing.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Summarized financial information related to this collaboration is as follows:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 |
Alliance revenue - Lenvima | Alliance revenue - Lenvima | $ | 188 | | | $ | 142 | | | $ | 498 | | | $ | 421 | | Alliance revenue - Lenvima | $ | 202 | | | $ | 188 | | | $ | 660 | | | $ | 498 | |
| Cost of sales (1) | Cost of sales (1) | 49 | | | 46 | | | 143 | | | 215 | | Cost of sales (1) | 53 | | | 49 | | | 159 | | | 143 | |
Selling, general and administrative | Selling, general and administrative | 34 | | | 18 | | | 88 | | | 48 | | Selling, general and administrative | 42 | | | 34 | | | 115 | | | 88 | |
Research and development | Research and development | 43 | | | 48 | | | 165 | | | 168 | | Research and development | 24 | | | 43 | | | 128 | | | 165 | |
| ($ in millions) | ($ in millions) | | September 30, 2021 | | December 31, 2020 | ($ in millions) | | September 30, 2022 | | December 31, 2021 |
Receivables from Eisai included in Other current assets | Receivables from Eisai included in Other current assets | | $ | 223 | | | $ | 157 | | Receivables from Eisai included in Other current assets | | $ | 202 | | | $ | 200 | |
Payables to Eisai included in Accrued and other current liabilities (2) | Payables to Eisai included in Accrued and other current liabilities (2) | | 600 | | | 335 | | Payables to Eisai included in Accrued and other current liabilities (2) | | 1 | | | 625 | |
Payables to Eisai included in Other Noncurrent Liabilities (3) | | — | | | 600 | | |
(1) Represents amortization of capitalized milestone payments.
(2) Includes accrued milestone and future option payments.
(3) IncludesAmount as of December 31, 2021 includes accrued milestone payments.
Bayer AG
In 2014, the Company entered into a worldwide clinical development collaboration with Bayer AG (Bayer) to market and develop soluble guanylate cyclase (sGC) modulators including Bayer’s Adempas (riociguat). The two companies have implemented a joint development and commercialization strategy. The collaboration also includes development of Bayer’s Verquvo (vericiguat), which was approved in the U.S. in January 2021, in Japan in June 2021 and in the EU in July 2021. Under the agreement, Bayer commercializes Adempas in the Americas, while Merck commercializes in the rest of the world. For Verquvo, Merck commercializes in the U.S. and Bayer commercializes in the rest of the world. Both companies share in development costs and profits on sales. Merck records sales of Adempas and Verquvo in its marketing territories, as well as alliance revenue. Alliance revenue represents Merck’s share of profits from sales of Adempas and Verquvo in Bayer’s marketing territories, which are product sales net of cost of sales and commercialization costs. Cost of sales includes Bayer’s share of profits from sales in Merck’s marketing territories.
In addition, the agreement providesprovided for contingent payments from Merck to Bayer related to the successful achievement of sales-based milestones. In January 2022, Merck made the first quarter of 2021, following the approval of Verquvo noted above, Merck determined it was probable that sales of Adempas and Verquvo in the future would trigger the remainingfinal $400 million sales-based milestone payment that was outstanding under this agreement. Accordingly, Merck recorded a liability of $400 million and a corresponding increasecollaboration to the intangible assets related to this collaboration. Merck also recognized $153 million of cumulative amortization expense related to the recognition of this milestone in the first nine months of 2021.Bayer.
The intangible asset balancebalances related to Adempas (which includes the acquired intangible asset balance, as well as capitalized sales-based milestone payments attributed to Adempas) was $869 million at September 30, 2021 and is being amortized over its estimated useful life through 2027 as supported by projected future cash flows, subject to impairment testing. The intangible asset balance related to Verquvo (which reflects the portion of the final sales-based milestone payment that was attributed to Verquvo) was $72were $597 million and $53 million, respectively, at September 30, 20212022 and isare included in Other Intangibles, Net. The assets are being amortized over itstheir estimated useful lifelives (through 2027 for Adempas and through 2031 for Verquvo) as supported by projected future cash flows, subject to impairment testing.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Summarized financial information related to this collaboration is as follows:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 |
Alliance revenue - Adempas/Verquvo | Alliance revenue - Adempas/Verquvo | $ | 100 | | | $ | 83 | | | $ | 248 | | | $ | 216 | | Alliance revenue - Adempas/Verquvo | $ | 88 | | | $ | 100 | | | $ | 258 | | | $ | 248 | |
Net sales of Adempas recorded by Merck | Net sales of Adempas recorded by Merck | 59 | | | 55 | | | 188 | | | 167 | | Net sales of Adempas recorded by Merck | 57 | | | 59 | | | 181 | | | 188 | |
Net sales of Verquvo recorded by Merck | Net sales of Verquvo recorded by Merck | 2 | | | — | | | 3 | | | — | | Net sales of Verquvo recorded by Merck | 6 | | | 2 | | | 15 | | | 3 | |
Total sales | Total sales | $ | 161 | | | $ | 138 | | | $ | 439 | | | $ | 383 | | Total sales | $ | 151 | | | $ | 161 | | | $ | 454 | | | $ | 439 | |
| Cost of sales (1) | Cost of sales (1) | 53 | | | 81 | | | 328 | | | 229 | | Cost of sales (1) | 55 | | | 53 | | | 158 | | | 328 | |
Selling, general and administrative | Selling, general and administrative | 31 | | | 12 | | | 84 | | | 32 | | Selling, general and administrative | 42 | | | 31 | | | 107 | | | 84 | |
Research and development | Research and development | 16 | | | 12 | | | 36 | | | 53 | | Research and development | 18 | | | 16 | | | 52 | | | 36 | |
| ($ in millions) | ($ in millions) | | September 30, 2021 | | December 31, 2020 | ($ in millions) | | September 30, 2022 | | December 31, 2021 |
Receivables from Bayer included in Other current assets | Receivables from Bayer included in Other current assets | | $ | 139 | | | $ | 65 | | Receivables from Bayer included in Other current assets | | $ | 144 | | | $ | 114 | |
Payables to Bayer included in Accrued and other current liabilities (2) | Payables to Bayer included in Accrued and other current liabilities (2) | | 467 | | | — | | Payables to Bayer included in Accrued and other current liabilities (2) | | 75 | | | 472 | |
(1)Includes amortization of intangible assets. Amount in the first nine months of 2021 includes $153 million of cumulative amortization as noted above.catch-up expense. In addition, cost of sales in all periods now includes Bayer’s share of profits from sales in Merck’s marketing territories.
(2)Includes Amount as of December 31, 2021 includes accrued milestone payment.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Ridgeback Biotherapeutics LP
In 2020, Merck and Ridgeback Biotherapeutics LP (Ridgeback), a closely held biotechnology company, entered into a collaboration agreement to develop Lagevrio (molnupiravir), an orally available antiviral candidate in clinical development for the treatment of patients with COVID-19. Merck gained exclusive worldwide rights to develop and commercialize Lagevrio and related molecules.
Under the terms of the agreement, Ridgeback received an upfront payment and is eligible to receive future contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. The agreement also provides for Merck to reimburse Ridgeback for a portion of certain third-party contingent milestone payments and royalties on net sales, which is part of the profit sharing calculation. Merck is the principal on sales transactions, recognizing sales and related costs, with profit sharing amounts recorded within Cost of sales. Profits from the collaboration are split equally between the partners. Reimbursements from Ridgeback for its share of research and development costs (deducted from Ridgeback’s share of profits) are reflected as decreases to Research and development expenses.
Lagevrio has received multiple authorizations or approvals worldwide and Merck has entered into advance purchase and supply agreements for Lagevrio in more than 40 markets. As of September 30, 2022, the Company has 0.8 million remaining courses to be supplied under these agreements.
Summarized financial information related to this collaboration is as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | 2022 | | 2021 | | 2022 | | 2021 |
Lagevrio sales | $ | 436 | | | $ | — | | | $ | 4,859 | | | $ | — | |
| | | | | | | |
Cost of sales (1) | 234 | | | 4 | | | 2,580 | | | 56 | |
Selling, general and administrative | 41 | | | 6 | | | 105 | | | 13 | |
Research and development | 8 | | | 58 | | | 29 | | | 167 | |
| | | | | | | |
($ in millions) | | | | | September 30, 2022 | | December 31, 2021 |
Payables to Ridgeback included in Accrued and other current liabilities (2) | | | | | $ | 193 | | | $ | 283 | |
(1) Includes royalty expense and amortization of capitalized milestone payments.
(2) Includes accrued royalty and milestone payments.
Bristol Myers Squibb
Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation recombinant fusion protein obtained as part of Merck’s November 2021 acquisition of Acceleron Pharma Inc. that is being developed and commercialized through a global collaboration with Bristol Myers Squibb (BMS). Reblozyl is approved in the U.S., Europe, Canada and Australia for the treatment of anemia in certain rare blood disorders and is also being evaluated for additional indications for hematology therapies. BMS is the principal on sales transactions for Reblozyl; however, Merck co-promotes Reblozyl (and will co-promote all future products approved under this collaboration) in North America, which is reimbursed by BMS. Merck receives a 20% sales royalty from BMS which could increase to a maximum of 24% based on sales levels. This royalty will be reduced by 50% upon the earlier of patent expiry or generic entry on an indication-by-indication basis in each market. Additionally, Merck is eligible to receive future contingent sales-based milestone payments of up to $80 million. Merck recorded alliance revenue of $39 million (consisting of royalties) within Sales in the third quarter of 2022 related to this collaboration. Merck recorded alliance revenue of $124 million in the first nine months of 2022, which includes royalties of $104 million, as well as the receipt of a regulatory approval milestone payment of $20 million.
5. Restructuring
In 2019, Merck approved a new global restructuring program (Restructuring Program) as part of a worldwide initiative focused on further optimizing the Company’s manufacturing and supply network, as well as reducing its global real estate footprint. This program is a continuation of the Company’s plant rationalization and builds on prior restructuring programs and does not include any actions associated with the spin-off of Organon. As the Company continues to evaluate its global footprint and overall operating model, it subsequently identified additional actions under the Restructuring Program, and could identify further actions over time.programs. The actions currently contemplated under the Restructuring Program are expected to be substantially completed by the end of 2023, with the cumulative pretax costs to be incurred by the Company to implement the program estimated to be approximately $3.0$3.5 billion. The Company estimates that approximately 70% of the cumulative pretax costs will result in cash outlays, primarily related to employee separation expense and facility shut-down costs. Approximately 30% of the cumulative pretax costs will be non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested.
The Company recorded total pretax costs of $168$175 million and $185$168 million in the third quarter of 20212022 and 2020,2021, respectively, and $630$559 million and $500$630 million for the first nine months of 20212022 and 2020,2021, respectively, related to
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
restructuring program activities. Since inception of the Restructuring Program through September 30, 2021,2022, Merck has recorded total pretax accumulated costs of approximately $2.4$3.2 billion. For the full year of 2021,2022, the Company expects to record charges of approximately $700$600 million related to the Restructuring Program. For segment reporting, restructuring charges are unallocated expenses.
The following tables summarize the charges related to restructuring program activities by type of cost:
| | | Three Months Ended September 30, 2021 | | Nine Months Ended September 30, 2021 | | Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2022 |
($ in millions) | ($ in millions) | Separation Costs | | Accelerated Depreciation | | Other | | Total | | Separation Costs | | Accelerated Depreciation | | Other | | Total | ($ in millions) | Separation Costs | | Accelerated Depreciation | | Other | | Total | | Separation Costs | | Accelerated Depreciation | | Other | | Total |
Cost of sales | Cost of sales | $ | — | | | $ | 11 | | | $ | 37 | | | $ | 48 | | | $ | — | | | $ | 32 | | | $ | 81 | | | $ | 113 | | Cost of sales | $ | — | | | $ | 16 | | | $ | 38 | | | $ | 54 | | | $ | — | | | $ | 51 | | | $ | 116 | | | $ | 167 | |
Selling, general and administrative | Selling, general and administrative | — | | | 4 | | | 1 | | | 5 | | | — | | | 8 | | | 1 | | | 9 | | Selling, general and administrative | — | | | 5 | | | 21 | | | 26 | | | — | | | 17 | | | 57 | | | 74 | |
Research and development | Research and development | — | | | 7 | | | 1 | | | 8 | | | — | | | 20 | | | 1 | | | 21 | | Research and development | — | | | — | | | 1 | | | 1 | | | — | | | 29 | | | 1 | | | 30 | |
Restructuring costs | Restructuring costs | 17 | | | — | | | 90 | | | 107 | | | 310 | | | — | | | 177 | | | 487 | | Restructuring costs | 65 | | | — | | | 29 | | | 94 | | | 197 | | | — | | | 91 | | | 288 | |
| | $ | 17 | | | $ | 22 | | | $ | 129 | | | $ | 168 | | | $ | 310 | | | $ | 60 | | | $ | 260 | | | $ | 630 | | | $ | 65 | | | $ | 21 | | | $ | 89 | | | $ | 175 | | | $ | 197 | | | $ | 97 | | | $ | 265 | | | $ | 559 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2020 | | Nine Months Ended September 30, 2020 |
($ in millions) | Separation Costs | | Accelerated Depreciation | | Other | | Total | | Separation Costs | | Accelerated Depreciation | | Other | | Total |
Cost of sales | $ | — | | | $ | 33 | | | $ | 5 | | | $ | 38 | | | $ | — | | | $ | 89 | | | $ | 42 | | | $ | 131 | |
Selling, general and administrative | — | | | 15 | | | — | | | 15 | | | — | | | 37 | | | — | | | 37 | |
Research and development | — | | | 18 | | | 1 | | | 19 | | | — | | | 66 | | | 1 | | | 67 | |
Restructuring costs | 61 | | | — | | | 52 | | | 113 | | | 143 | | | — | | | 122 | | | 265 | |
| $ | 61 | | | $ | 66 | | | $ | 58 | | | $ | 185 | | | $ | 143 | | | $ | 192 | | | $ | 165 | | | $ | 500 | |
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2021 | | Nine Months Ended September 30, 2021 |
($ in millions) | Separation Costs | | Accelerated Depreciation | | Other | | Total | | Separation Costs | | Accelerated Depreciation | | Other | | Total |
Cost of sales | $ | — | | | $ | 11 | | | $ | 37 | | | $ | 48 | | | $ | — | | | $ | 32 | | | $ | 81 | | | $ | 113 | |
Selling, general and administrative | — | | | 4 | | | 1 | | | 5 | | | — | | | 8 | | | 1 | | | 9 | |
Research and development | — | | | 7 | | | 1 | | | 8 | | | — | | | 20 | | | 1 | | | 21 | |
Restructuring costs | 17 | | | — | | | 90 | | | 107 | | | 310 | | | — | | | 177 | | | 487 | |
| $ | 17 | | | $ | 22 | | | $ | 129 | | | $ | 168 | | | $ | 310 | | | $ | 60 | | | $ | 260 | | | $ | 630 | |
Separation costs are associated with actual headcount reductions, as well as those headcount reductions which were probable and could be reasonably estimated.
Accelerated depreciation costs primarily relate to manufacturing, research and administrative facilities and equipment to be sold or closed as part of the programs.program. Accelerated depreciation costs represent the difference between the depreciation expense to be recognized over the revised useful life of the asset, based upon the anticipated date the site will be closed or divested or the equipment disposed of, and depreciation expense as determined utilizing the useful life prior to the restructuring actions. All the sites have and will continue to operate up through the respective closure dates and, since future undiscounted cash flows are sufficient to recover the respective book values, Merck is recording accelerated depreciation over the revised useful life of the site assets. Anticipated site closure dates, particularly related to manufacturing locations, have been and may continue to be adjusted to reflect changes resulting from regulatory or other factors.
Other activity in 20212022 and 20202021 includes asset abandonment, facility shut-down and other related costs, as well as pretax gains and losses resulting from the sales of facilities and related assets. Additionally, other activity includes certain employee-related costs associated with pension and other postretirement benefit plans (see Note 11) and share-based compensation.
The following table summarizes the charges and spending relating to restructuring program activities for the nine months ended September 30, 2021:2022:
| ($ in millions) | ($ in millions) | Separation Costs | | Accelerated Depreciation | | Other | | Total | ($ in millions) | Separation Costs | | Accelerated Depreciation | | Other | | Total |
Restructuring reserves January 1, 2021 | $ | 567 | | | $ | — | | | $ | 19 | | | $ | 586 | | |
Restructuring reserves January 1, 2022 | | Restructuring reserves January 1, 2022 | $ | 596 | | | $ | — | | | $ | 41 | | | $ | 637 | |
Expense | Expense | 310 | | | 60 | | | 260 | | | 630 | | Expense | 197 | | | 97 | | | 265 | | | 559 | |
(Payments) receipts, net | (Payments) receipts, net | (305) | | | — | | | (155) | | | (460) | | (Payments) receipts, net | (303) | | | — | | | (458) | | | (761) | |
Non-cash activity | Non-cash activity | — | | | (60) | | | (84) | | | (144) | | Non-cash activity | — | | | (97) | | | 183 | | | 86 | |
Restructuring reserves September 30, 2021 (1) | $ | 572 | | | $ | — | | | $ | 40 | | | $ | 612 | | |
Restructuring reserves September 30, 2022 (1) | | Restructuring reserves September 30, 2022 (1) | $ | 490 | | | $ | — | | | $ | 31 | | | $ | 521 | |
(1)The remaining cash outlays are expected to be substantially completed by the end of 2023.
6. 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.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
A significant portion of the Company’s revenues and earnings in foreign affiliates is exposed to changes in foreign exchange rates. The objectives of and accounting related to the Company’s foreign currency risk management program, as well as its interest rate risk management activities are discussed below.
Foreign Currency Risk Management
The Company has established revenue hedging, balance sheet risk management and net investment hedging programs to protect against volatility of future foreign currency cash flows and changes in fair value caused by changes in foreign exchange rates.
The objective of the revenue hedging program is to reduce the variability caused by changes in foreign exchange rates that would affect the U.S. dollar value of future cash flows derived from foreign currency denominated sales, primarily the euro, Japanese yen and Chinese renminbi. To achieve this objective, the Company will hedge a portion of its forecasted foreign currency denominated third-party and intercompany distributor entity sales (forecasted sales) that are expected to occur over its planning cycle, typically no more than two years into the future. The Company will layer in hedges over time, increasing the portion of forecasted sales hedged as it gets closer to the expected date of the forecasted sales. The portion of forecasted 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 Company manages its anticipated transaction exposure principally with purchased local currency put options, forward contracts and purchased collar options.
The fair values of these derivative contracts are recorded as either assets (gain positions) or liabilities (loss positions) in the Condensed Consolidated Balance Sheet. Changes in the fair value of derivative contracts are recorded each period in either current earnings or Other comprehensive income (OCI)(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 unrealized gains or losses on these contracts are recorded in AOCLAccumulated Other Comprehensive Loss (AOCL) and reclassified into Sales when the hedged anticipated revenue is recognized. For those derivatives which are not designated as cash flow hedges, but serve as economic hedges of forecasted sales, unrealized gains or losses are recorded in Sales each period. The cash flows from both designated and non-
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
designatednon-designated contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows. The Company does not enter into derivatives for trading or speculative purposes.
The Company manages operating activities and net asset positions at each local subsidiary in order to mitigate the effects of exchange on monetary assets and liabilities. The Company also uses a balance sheet risk management program to mitigate the exposure of net monetary assets that are denominated in a currency other than a subsidiary’s functional currency from the effects of volatility in foreign exchange. In these instances, Merck principally utilizes forward exchange contracts to offset the effects of exchange on exposures denominated in developed country currencies, primarily the euro, Japanese yen, British pound, Canadian dollar and Japanese yen.Swiss franc. For exposures in developing country currencies, including the Chinese renminbi, 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 cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows.
Monetary assets and liabilities denominated in a currency other than the functional currency of a given subsidiary 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.
The Company also uses forward exchange contracts to hedge a portion of its net investment in foreign operations against movements in exchange rates. The forward contracts are designated as hedges of the net investment in a foreign operation. The unrealized gains or losses on these contracts are recorded in foreign currency translation adjustment within OCI and remain in AOCL until either the sale or complete or substantially complete liquidation of the subsidiary. The Company excludes certain portions of the change in fair value of its derivative instruments from the assessment of hedge effectiveness (excluded components). Changes in fair value of the excluded components are recognized in OCI. The Company recognizes in earnings the initial value of the excluded components on a straight-line basis over the life of the derivative instrument, rather than using the mark-to-market approach. The cash flows from these contracts are reported as investing activities in the Condensed Consolidated Statement of Cash Flows.
Foreign exchange risk is also managed through the use of foreign currency debt. The Company’s 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 due to spot rate fluctuations on the euro-denominated debt instruments are included in foreign currency translation adjustment within OCI.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
The effects of the Company’s net investment hedges on OCI and the Consolidated Statement of Income are shown below:
| | | Amount of Pretax (Gain) Loss Recognized in Other Comprehensive Income (1) | | Amount of Pretax (Gain) Loss Recognized in Other (income) expense, net for Amounts Excluded from Effectiveness Testing | | Amount of Pretax (Gain) Loss Recognized in Other Comprehensive Income (1) | | Amount of Pretax (Gain) Loss Recognized in Other (income) expense, net for Amounts Excluded from Effectiveness Testing |
| | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 | | 2022 | | 2021 | | 2022 | | 2021 |
Net Investment Hedging Relationships | Net Investment Hedging Relationships | | Net Investment Hedging Relationships | |
Foreign exchange contracts | Foreign exchange contracts | $ | 1 | | | $ | 10 | | | $ | (27) | | | $ | 15 | | | $ | (4) | | | $ | (4) | | | $ | (12) | | | $ | (15) | | Foreign exchange contracts | $ | (1) | | | $ | 1 | | | $ | (47) | | | $ | (27) | | | $ | — | | | $ | (4) | | | $ | (2) | | | $ | (12) | |
Euro-denominated notes | Euro-denominated notes | (77) | | | 162 | | | (199) | | | 182 | | | — | | | — | | | — | | | — | | Euro-denominated notes | (250) | | | (77) | | | (431) | | | (199) | | | — | | | — | | | — | | | — | |
(1) No amounts were reclassified from AOCL into income related to the sale of a subsidiary.
Interest Rate Risk Management
The Company may use interest rate swap contracts on certain investing and borrowing transactions to manage its net exposure to interest rate changes and to reduce its overall cost of borrowing. The Company does not use leveraged swaps and, in general, does not leverage any of its investment activities that would put principal capital at risk.
In January 2021, 5February 2022, five interest rate swapsswap contracts with a total notional amount of $1.15$1.25 billion matured. These swaps effectively converted the Company’s $1.15$1.25 billion, 3.875%2.35% fixed-rate notes due 20212022 to variable rate debt. AtIn September 30, 2021, the Company was a party to 9 pay-floating, receive-fixed2022, four interest rate swap contracts designated as fair value hedges of fixed-rate notes in which thewith a total notional amounts match the amount of $1.0 billion matured. These swaps effectively converted the hedged fixed-rateCompany’s $1.0 billion, 2.40% fixed rate notes as detailed in the table below.
Notesdue 2022 to Condensed Consolidated Financial Statements (unaudited) (continued)
| | | | | | | | | | | | | | | | | |
| September 30, 2021 |
($ in millions) | Par Value of Debt | | Number of Interest Rate Swaps Held | | Total Swap Notional Amount |
2.40% notes due 2022 | $ | 1,000 | | | 4 | | | $ | 1,000 | |
2.35% notes due 2022 | 1,250 | | | 5 | | | 1,250 | |
variable rate debt. The interest rate swap contracts arewere designated hedges of the fair value changes in the notes attributable to changes in the benchmark LIBOR swap rate. The fair value changes in the notes attributable to changes in the LIBOR swap rate arewere recorded in interest expense along with the offsetting fair value changes in the swap contracts. The cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows. The Company is not currently a party to any interest rate swaps.
The table below presents the location of amounts recorded onin the Condensed Consolidated Balance Sheet related to cumulative basis adjustments for fair value hedges:
| | | Carrying Amount of Hedged Liabilities | | Cumulative Amount of Fair Value Hedging Adjustment Increase (Decrease) Included in the Carrying Amount | | Carrying Amount of Hedged Liabilities | | Cumulative Amount of Fair Value Hedging Adjustment Increase (Decrease) Included in the Carrying Amount |
($ in millions) | ($ in millions) | September 30, 2021 | | December 31, 2020 | | September 30, 2021 | | December 31, 2020 | ($ in millions) | September 30, 2022 | | December 31, 2021 | | September 30, 2022 | | December 31, 2021 |
Balance Sheet Line Item in which Hedged Item is Included | | Balance Sheet Line Item in which Hedged Item is Included | |
Loans payable and current portion of long-term debt | Loans payable and current portion of long-term debt | $ | 2,274 | | | $ | 1,150 | | | $ | 25 | | | $ | — | | Loans payable and current portion of long-term debt | $ | — | | | $ | 2,263 | | | $ | — | | | $ | 13 | |
Long-Term Debt | — | | | 2,301 | | | — | | | 53 | | |
Presented in the table below is the fair value of derivatives on a gross basis segregated between those derivatives that are designated as hedging instruments and those that are not designated as hedging instruments:
| | | | September 30, 2021 | | December 31, 2020 | | | September 30, 2022 | | December 31, 2021 |
| | | Fair Value of Derivative | | U.S. Dollar Notional | | Fair Value of Derivative | | U.S. Dollar Notional | | | Fair Value of Derivative | | U.S. Dollar Notional | | Fair Value of Derivative | | U.S. Dollar Notional |
($ in millions) | ($ in millions) | | Asset | | Liability | | Asset | | Liability | | ($ in millions) | | Asset | | Liability | | Asset | | Liability | |
Derivatives Designated as Hedging Instruments | Derivatives Designated as Hedging Instruments | Balance Sheet Caption | | Derivatives Designated as Hedging Instruments | Balance Sheet Caption | |
Interest rate swap contracts | Other current assets | $ | 26 | | | $ | — | | | $ | 2,250 | | | $ | 1 | | | $ | — | | | $ | 1,150 | | |
Interest rate swap contracts | Interest rate swap contracts | Other Assets | — | | | — | | | — | | | 54 | | | — | | | 2,250 | | Interest rate swap contracts | Other current assets | $ | — | | | $ | — | | | $ | — | | | $ | 14 | | | $ | — | | | $ | 2,250 | |
Foreign exchange contracts | Foreign exchange contracts | Other current assets | 224 | | | — | | | 7,138 | | | 12 | | | — | | | 3,183 | | Foreign exchange contracts | Other current assets | 826 | | | — | | | 7,250 | | | 271 | | | — | | | 6,778 | |
Foreign exchange contracts | Foreign exchange contracts | Other Assets | 45 | | | — | | | 1,469 | | | 45 | | | — | | | 2,030 | | Foreign exchange contracts | Other Assets | 85 | | | — | | | 1,408 | | | 43 | | | — | | | 1,551 | |
Foreign exchange contracts | Foreign exchange contracts | Accrued and other current liabilities | — | | | 15 | | | 1,601 | | | — | | | 217 | | | 5,049 | | Foreign exchange contracts | Accrued and other current liabilities | — | | | 1 | | | 37 | | | — | | | 24 | | | 1,623 | |
Foreign exchange contracts | Foreign exchange contracts | Other Noncurrent Liabilities | — | | | 1 | | | 145 | | | — | | | 1 | | | 52 | | Foreign exchange contracts | Other Noncurrent Liabilities | — | | | 1 | | | 93 | | | — | | | 1 | | | 43 | |
| | | $ | 295 | | | $ | 16 | | | $ | 12,603 | | | $ | 112 | | | $ | 218 | | | $ | 13,714 | | | | $ | 911 | | | $ | 2 | | | $ | 8,788 | | | $ | 328 | | | $ | 25 | | | $ | 12,245 | |
Derivatives Not Designated as Hedging Instruments | Derivatives Not Designated as Hedging Instruments | Balance Sheet Caption | | | | | | | | | | | | Derivatives Not Designated as Hedging Instruments | Balance Sheet Caption | | | | | | | | | | | |
Foreign exchange contracts | Foreign exchange contracts | Other current assets | $ | 82 | | | $ | — | | | $ | 6,333 | | | $ | 70 | | | $ | — | | | $ | 7,260 | | Foreign exchange contracts | Other current assets | $ | 597 | | | $ | — | | | $ | 9,523 | | | $ | 221 | | | $ | — | | | $ | 10,073 | |
Foreign exchange contracts | Foreign exchange contracts | Accrued and other current liabilities | — | | | 117 | | | 9,522 | | | — | | | 307 | | | 11,810 | | Foreign exchange contracts | Accrued and other current liabilities | — | | | 240 | | | 7,715 | | | — | | | 96 | | | 10,640 | |
| | | $ | 82 | | | $ | 117 | | | $ | 15,855 | | | $ | 70 | | | $ | 307 | | | $ | 19,070 | | | | $ | 597 | | | $ | 240 | | | $ | 17,238 | | | $ | 221 | | | $ | 96 | | | $ | 20,713 | |
| | | $ | 377 | | | $ | 133 | | | $ | 28,458 | | | $ | 182 | | | $ | 525 | | | $ | 32,784 | | | | $ | 1,508 | | | $ | 242 | | | $ | 26,026 | | | $ | 549 | | | $ | 121 | | | $ | 32,958 | |
As noted above, the Company records its derivatives on a gross basis in the Condensed Consolidated Balance Sheet. The Company has master netting agreements with several of its financial institution counterparties (see Concentrations of Credit Risk below). The following table provides information on the Company’s derivative positions subject to these master
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
netting arrangements as if they were presented on a net basis, allowing for the right of offset by counterparty and cash collateral exchanged per the master agreements and related credit support annexes:
| | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2021 | | December 31, 2020 |
($ in millions) | Asset | | Liability | | Asset | | Liability |
Gross amounts recognized in the condensed consolidated balance sheet | $ | 377 | | | $ | 133 | | | $ | 182 | | | $ | 525 | |
Gross amounts subject to offset in master netting arrangements not offset in the condensed consolidated balance sheet | (120) | | | (120) | | | (156) | | | (156) | |
Cash collateral received/posted | (65) | | | — | | | — | | | (36) | |
Net amounts | $ | 192 | | | $ | 13 | | | $ | 26 | | | $ | 333 | |
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
| | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
($ in millions) | Asset | | Liability | | Asset | | Liability |
Gross amounts recognized in the condensed consolidated balance sheet | $ | 1,508 | | | $ | 242 | | | $ | 549 | | | $ | 121 | |
Gross amounts subject to offset in master netting arrangements not offset in the condensed consolidated balance sheet | (217) | | | (217) | | | (110) | | | (110) | |
Cash collateral received | (794) | | | — | | | (164) | | | — | |
Net amounts | $ | 497 | | | $ | 25 | | | $ | 275 | | | $ | 11 | |
The table below provides information regarding the location and amount of pretax (gains)gains and losses of derivatives designated in fair value or cash flow hedging relationships (including amounts attributable to discontinued operations):relationships:
| | | Sales | | Other (income) expense, net (1) | | Other comprehensive income (loss) | | Sales | | Other (income) expense, net (1) | | Other comprehensive income (loss) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Three Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Nine Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | | 2021 | | 2020 | | 2021 | | 2020 | | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 | | 2022 | | 2021 | | 2022 | | 2021 | | 2022 | | 2021 | | 2022 | | 2021 |
Financial Statement Line Items in which Effects of Fair Value or Cash Flow Hedges are Recorded | Financial Statement Line Items in which Effects of Fair Value or Cash Flow Hedges are Recorded | $ | 13,154 | | | $ | 10,929 | | | $ | (450) | | | $ | (312) | | | $ | 38 | | | $ | 10 | | | $ | 35,183 | | | $ | 30,570 | | | $ | (1,007) | | | $ | (637) | | | $ | 1,595 | | | $ | (190) | | Financial Statement Line Items in which Effects of Fair Value or Cash Flow Hedges are Recorded | Sales | | Other (income) expense, net (1) | | Other comprehensive income (loss) | | Sales | | Other (income) expense, net (1) | | Other comprehensive income (loss) |
| | | $ | 14,959 | | | $ | 13,154 | | | $ | 429 | | | $ | (450) | | | $ | (416) | | | $ | 38 | | | $ | 45,453 | | | $ | 35,183 | | | $ | 1,576 | | | $ | (1,007) | | | $ | (314) | | | $ | 1,595 | |
(Gain) loss on fair value hedging relationships | (Gain) loss on fair value hedging relationships | | (Gain) loss on fair value hedging relationships | |
Interest rate swap contracts | Interest rate swap contracts | | Interest rate swap contracts | |
Hedged items | Hedged items | — | | | — | | | (9) | | | (14) | | | — | | | — | | | — | | | — | | | (29) | | | 54 | | | — | | | — | | Hedged items | — | | | — | | | 1 | | | (9) | | | — | | | — | | | — | | | — | | | (13) | | | (29) | | | — | | | — | |
Derivatives designated as hedging instruments | Derivatives designated as hedging instruments | — | | | — | | | (1) | | | — | | | — | | | — | | | — | | | — | | | (1) | | | (76) | | | — | | | — | | Derivatives designated as hedging instruments | — | | | — | | | — | | | (1) | | | — | | | — | | | — | | | — | | | 4 | | | (1) | | | — | | | — | |
Impact of cash flow hedging relationships | Impact of cash flow hedging relationships | | Impact of cash flow hedging relationships | |
Foreign exchange contracts | Foreign exchange contracts | | Foreign exchange contracts | |
Amount of gain (loss) recognized in OCI on derivatives | — | | | — | | | — | | | — | | | 72 | | | (195) | | | — | | | — | | | — | | | — | | | 193 | | | (126) | | |
(Decrease) increase in Sales as a result of AOCL reclassifications | (36) | | | (23) | | | — | | | — | | | 36 | | | 23 | | | (219) | | | 65 | | | — | | | — | | | 219 | | | (65) | | |
Amount of gain recognized in OCI on derivatives | | Amount of gain recognized in OCI on derivatives | — | | | — | | | — | | | — | | | 682 | | | 72 | | | — | | | — | | | — | | | — | | | 1,233 | | | 193 | |
Increase (decrease) in Sales as a result of AOCL reclassifications | | Increase (decrease) in Sales as a result of AOCL reclassifications | 253 | | | (36) | | | — | | | — | | | (253) | | | 36 | | | 491 | | | (219) | | | — | | | — | | | (491) | | | 219 | |
Interest rate contracts | Interest rate contracts | | Interest rate contracts | |
Amount of gain recognized in Other (income) expense, net on derivatives | Amount of gain recognized in Other (income) expense, net on derivatives | — | | | — | | | — | | | (1) | | | — | | | — | | | — | | | — | | | (2) | | | (3) | | | — | | | — | | Amount of gain recognized in Other (income) expense, net on derivatives | — | | | — | | | (1) | | | — | | | — | | | — | | | — | | | — | | | (2) | | | (2) | | | — | | | — | |
Amount of loss recognized in OCI on derivatives | Amount of loss recognized in OCI on derivatives | — | | | — | | | — | | | — | | | — | | | (1) | | | — | | | — | | | — | | | — | | | (2) | | | (3) | | Amount of loss recognized in OCI on derivatives | — | | | — | | | — | | | — | | | (1) | | | — | | | — | | | — | | | — | | | — | | | (2) | | | (2) | |
(1) Interest expense is a component of Other (income) expense, net.
The table below provides information regarding the income statement effects of derivatives not designated as hedging instruments (including amounts attributable to discontinued operations):instruments:
| | | Amount of Derivative Pretax (Gain) Loss Recognized in Income | | Amount of Derivative Pretax (Gain) Loss Recognized in Income |
| | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | | 2022 | | 2021 | | 2022 | | 2021 |
Derivatives Not Designated as Hedging Instruments | Derivatives Not Designated as Hedging Instruments | Income Statement Caption | | Derivatives Not Designated as Hedging Instruments | Income Statement Caption | |
Foreign exchange contracts (1) | Foreign exchange contracts (1) | Other (income) expense, net | | $ | 18 | | | $ | (7) | | | $ | 234 | | | $ | (138) | | Foreign exchange contracts (1) | Other (income) expense, net | | $ | (41) | | | $ | 18 | | | $ | (77) | | | $ | 234 | |
Foreign exchange contracts (2) | Foreign exchange contracts (2) | Sales | | (4) | | | 7 | | | 6 | | | 4 | | Foreign exchange contracts (2) | Sales | | (4) | | | (4) | | | (42) | | | 6 | |
Interest rate contracts (3) | Other (income) expense, net | | — | | | — | | | — | | | 9 | | |
Forward contract related to Seagen common stock | Research and development | | — | | | 22 | | | — | | | 22 | | |
(1) These derivative contracts primarily mitigate changes in the value of remeasured foreign currency denominated monetary assets and liabilities attributable to changes in foreign currency exchange rates. Amount in the first nine months of 2021 includes a loss on forward exchange contracts entered into in conjunction with the spin-off of Organon.
(2) These derivative contracts serve as economic hedges of forecasted transactions.
(3) These derivative contracts serve as economic hedges against rising treasury rates.
At September 30, 2021,2022, the Company estimates $55$864 million of pretax net unrealized gains on derivatives maturing within the next 12 months that hedge foreign currency denominated sales over that same period will be reclassified from AOCL to Sales. The amount ultimately reclassified to Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual exchange rates at maturity.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Investments in Debt and Equity Securities
Information on investments in debt and equity securities is as follows:
| | | September 30, 2021 | | December 31, 2020 | | September 30, 2022 | | December 31, 2021 |
| | Amortized Cost | | Gross Unrealized | | Fair Value | | Amortized Cost | | Gross Unrealized | | Fair Value | | Amortized Cost | | Gross Unrealized | | Fair Value | | Amortized Cost | | Gross Unrealized | | Fair Value |
($ in millions) | ($ in millions) | Gains | | Losses | | Gains | | Losses | | ($ in millions) | Gains | | Losses | | Gains | | Losses | |
U.S. government and agency securities | U.S. government and agency securities | $ | 83 | | | $ | — | | | $ | — | | | $ | 83 | | | $ | 84 | | | $ | — | | | $ | — | | | $ | 84 | | U.S. government and agency securities | $ | 67 | | | $ | — | | | $ | — | | | $ | 67 | | | $ | 80 | | | $ | — | | | $ | — | | | $ | 80 | |
Commercial paper | | Commercial paper | 4 | | | — | | | — | | | 4 | | | — | | | — | | | — | | | — | |
Corporate notes and bonds | Corporate notes and bonds | 4 | | | — | | | — | | | 4 | | | — | | | — | | | — | | | — | | Corporate notes and bonds | 3 | | | — | | | — | | | 3 | | | 4 | | | — | | | — | | | 4 | |
Foreign government bonds | Foreign government bonds | 2 | | | — | | | — | | | 2 | | | 5 | | | — | | | — | | | 5 | | Foreign government bonds | 2 | | | — | | | — | | | 2 | | | 2 | | | — | | | — | | | 2 | |
Total debt securities | Total debt securities | $ | 89 | | | $ | — | | | $ | — | | | $ | 89 | | | $ | 89 | | | $ | — | | | $ | — | | | $ | 89 | | Total debt securities | $ | 76 | | | $ | — | | | $ | — | | | $ | 76 | | | $ | 86 | | | $ | — | | | $ | — | | | $ | 86 | |
Publicly traded equity securities (1) | Publicly traded equity securities (1) | | 1,915 | | | 1,787 | | Publicly traded equity securities (1) | | 1,334 | | | 1,647 | |
Total debt and publicly traded equity securities | Total debt and publicly traded equity securities | | $ | 2,004 | | | $ | 1,876 | | Total debt and publicly traded equity securities | | $ | 1,410 | | | $ | 1,733 | |
(1) Unrealized net gainslosses of $90$221 million and unrealized$415 million were recorded in Other (income) expense, net in the third quarter and first nine months of 2022, respectively, on equity securities still held at September 30, 2022. Unrealized net (gains) losses of $(90) million and $109 million were recorded in Other (income) expense, net on equity securities still held at September 30, 2021 in the third quarter and first nine months of 2021, respectively. Unrealized net gains recorded in Other (income) expense, netrespectively, on equity securities still held at September 30, 2020 were $43 million and $512 million in the third quarter and first nine months of 2020, respectively.2021.
At September 30, 20212022 and September 30, 2020,2021, the Company also had $578$705 million and $508$578 million, respectively, of equity investments without readily determinable fair values included in Other Assets. The Company recognizesrecords unrealized gains on these equity investments based on favorable observable price changes from transactions involving similar investments of the same investee and recognizesrecords unrealized losses based on unfavorable observable price changes.changes, which are included in Other (income) expense, net. During the first nine monthsof 2022, the Company recorded unrealized gains of $21 million and unrealized net losses of $12 million related to certain of these equity investments still held at September 30, 2022. During the first nine months of 2021, the Company recorded unrealized gains of $104 million and unrealized losses of $1 million in Other (income) expense, net related to certain of these equity investments still held at September 30, 2021. During the first nine monthsof 2020, the Company recorded unrealized gains of $21 million and unrealized losses of $3 million in Other (income) expense, net related to these equity investments held at September 30, 2020. Cumulative unrealized gains and cumulative unrealized losses based on observable pricesprice changes for investments in equity investments without readily determinable fair values still held at September 30, 20212022 were $229$255 million and $7$19 million, respectively.
At September 30, 2022 and September 30, 2021, the Company also had $655 million and $1.2 billion, respectively, recorded in Other Assets for equity securities held through ownership interests in investment funds. Losses (gains) recorded in Other (income) expense, net relating to these investment funds were $141 million and $(391) million for the third quarter of 2022 and 2021, respectively, and were $952 million and $(893) million for the first nine months of 2022 and 2021, respectively.
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. The Company uses 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 used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities;
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;
Level 3 - Unobservable inputs that are supported by little or no market activity. Level 3 assets or liabilities are those whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques with significant unobservable inputs, as well as assets or liabilities for which the determination of fair value requires significant judgment or estimation.
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.
Notes to Condensed 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 | | Fair Value Measurements Using | | Fair Value Measurements Using |
| | Level 1 | | Level 2 | | Level 3 | | Total | | Level 1 | | Level 2 | | Level 3 | | Total | | Level 1 | | Level 2 | | Level 3 | | Total | | Level 1 | | Level 2 | | Level 3 | | Total |
($ in millions) | ($ in millions) | September 30, 2021 | | December 31, 2020 | ($ in millions) | September 30, 2022 | | December 31, 2021 |
Assets | Assets | | Assets | |
Investments | Investments | | Investments | |
Commercial paper | | Commercial paper | $ | — | | | $ | 4 | | | $ | — | | | $ | 4 | | | $ | — | | | $ | — | | | $ | — | | | $ | — | |
Foreign government bonds | Foreign government bonds | $ | — | | | $ | 2 | | | $ | — | | | $ | 2 | | | $ | — | | | $ | 5 | | | $ | — | | | $ | 5 | | Foreign government bonds | — | | | 2 | | | — | | | 2 | | | — | | | 2 | | | — | | | 2 | |
Publicly traded equity securities | Publicly traded equity securities | 433 | | | — | | | — | | | 433 | | | 780 | | | — | | | — | | | 780 | | Publicly traded equity securities | 1,081 | | | — | | | — | | | 1,081 | | | 368 | | | — | | | — | | | 368 | |
| | 433 | | | 2 | | | — | | | 435 | | | 780 | | | 5 | | | — | | | 785 | | | 1,081 | | | 6 | | | — | | | 1,087 | | | 368 | | | 2 | | | — | | | 370 | |
Other assets (1) | Other assets (1) | | Other assets (1) | |
U.S. government and agency securities | U.S. government and agency securities | 83 | | | — | | | — | | | 83 | | | 84 | | | — | | | — | | | 84 | | U.S. government and agency securities | 67 | | | — | | | — | | | 67 | | | 80 | | | — | | | — | | | 80 | |
Corporate notes and bonds | Corporate notes and bonds | 4 | | | — | | | — | | | 4 | | | — | | | — | | | — | | | — | | Corporate notes and bonds | 3 | | | — | | | — | | | 3 | | | 4 | | | — | | | — | | | 4 | |
Publicly traded equity securities | Publicly traded equity securities | 1,482 | | | — | | | — | | | 1,482 | | | 1,007 | | | — | | | — | | | 1,007 | | Publicly traded equity securities | 253 | | | — | | | — | | | 253 | | | 1,279 | | | — | | | — | | | 1,279 | |
| | 1,569 | | | — | | | — | | | 1,569 | | | 1,091 | | | — | | | — | | | 1,091 | | | 323 | | | — | | | — | | | 323 | | | 1,363 | | | — | | | — | | | 1,363 | |
Derivative assets (2) | Derivative assets (2) | | Derivative assets (2) | |
Forward exchange contracts | Forward exchange contracts | — | | | 230 | | | — | | | 230 | | | — | | | 90 | | | — | | | 90 | | Forward exchange contracts | — | | | 945 | | | — | | | 945 | | | — | | | 351 | | | — | | | 351 | |
Purchased currency options | Purchased currency options | — | | | 121 | | | — | | | 121 | | | — | | | 37 | | | — | | | 37 | | Purchased currency options | — | | | 563 | | | — | | | 563 | | | — | | | 184 | | | — | | | 184 | |
Interest rate swaps | Interest rate swaps | — | | | 26 | | | — | | | 26 | | | — | | | 55 | | | — | | | 55 | | Interest rate swaps | — | | | — | | | — | | | — | | | — | | | 14 | | | — | | | 14 | |
| | — | | | 377 | | | — | | | 377 | | | — | | | 182 | | | — | | | 182 | | | — | | | 1,508 | | | — | | | 1,508 | | | — | | | 549 | | | — | | | 549 | |
Total assets | Total assets | $ | 2,002 | | | $ | 379 | | | $ | — | | | $ | 2,381 | | | $ | 1,871 | | | $ | 187 | | | $ | — | | | $ | 2,058 | | Total assets | $ | 1,404 | | | $ | 1,514 | | | $ | — | | | $ | 2,918 | | | $ | 1,731 | | | $ | 551 | | | $ | — | | | $ | 2,282 | |
Liabilities | Liabilities | | Liabilities | |
Other liabilities | Other liabilities | | Other liabilities | |
Contingent consideration | Contingent consideration | $ | — | | | $ | — | | | $ | 902 | | | $ | 902 | | | $ | — | | | $ | — | | | $ | 841 | | | $ | 841 | | Contingent consideration | $ | — | | | $ | — | | | $ | 499 | | | $ | 499 | | | $ | — | | | $ | — | | | $ | 777 | | | $ | 777 | |
Derivative liabilities (2) | Derivative liabilities (2) | | Derivative liabilities (2) | |
Forward exchange contracts | Forward exchange contracts | — | | | 132 | | | — | | | 132 | | | — | | | 505 | | | — | | | 505 | | Forward exchange contracts | — | | | 242 | | | — | | | 242 | | | — | | | 120 | | | — | | | 120 | |
Written currency options | Written currency options | — | | | 1 | | | — | | | 1 | | | — | | | 20 | | | — | | | 20 | | Written currency options | — | | | — | | | — | | | — | | | — | | | 1 | | | — | | | 1 | |
| | — | | | 133 | | | — | | | 133 | | | — | | | 525 | | | — | | | 525 | | | — | | | 242 | | | — | | | 242 | | | — | | | 121 | | | — | | | 121 | |
Total liabilities | Total liabilities | $ | — | | | $ | 133 | | | $ | 902 | | | $ | 1,035 | | | $ | — | | | $ | 525 | | | $ | 841 | | | $ | 1,366 | | Total liabilities | $ | — | | | $ | 242 | | | $ | 499 | | | $ | 741 | | | $ | — | | | $ | 121 | | | $ | 777 | | | $ | 898 | |
(1) Investments included in other assets are restricted as to use, including for the payment of benefits under employee benefit plans.
(2) The fair value determination of derivatives includes the impact of the credit risk of counterparties to the derivatives and the Company’s own credit risk, the effects of which were not significant.
As of September 30, 20212022 and December 31, 2020,2021, Cash and cash equivalents included $9.2$10.0 billion and $6.8 billion of cash equivalents, respectively (which would be considered Level 2 in the fair value hierarchy).
Contingent Consideration
Summarized information about the changes in the fair value of liabilities for contingent consideration associated with business acquisitionscombinations is as follows:
| | | Nine Months Ended September 30, | | | | | | | | | | |
($ in millions) | ($ in millions) | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 |
January 1 | $ | 841 | | | $ | 767 | | |
Additions | — | | | 97 | | |
Fair value January 1 | | Fair value January 1 | $ | 777 | | | $ | 841 | |
Changes in estimated fair value (1) | Changes in estimated fair value (1) | 73 | | | 71 | | Changes in estimated fair value (1) | (156) | | | 73 | |
Payments | Payments | — | | | (106) | | Payments | (119) | | | — | |
Other | Other | (12) | | | — | | Other | (3) | | | (12) | |
September 30 (2)(3) | $ | 902 | | | $ | 829 | | |
Fair value September 30 (2) | | Fair value September 30 (2) | $ | 499 | | | $ | 902 | |
(1) Recorded in Cost of sales, Research and development expenses, and Other (income) expense, net. Includes cumulative translation adjustments.
(2) Balance at September 30, 2021 includes $289 million recorded as a current liability for amounts expected to be paid within the next 12 months.
(3)At September 30, 2021 and December 31, 2020, $7472022, $358 million and $711 million, respectively, of the liabilities relate to the 2016 termination of the Sanofi Pasteur MSD joint venture in 2016.venture. As part of the termination, Merck recorded a liability for contingent future royalty payments of 11.5% on net sales of all Merck products that were previously sold by the joint venture through December 31, 2024. The fair value of this liability is determined utilizing the estimated amount and timing of projected cash flows using a risk-adjusted discount rate of 8% to present value the cash flows. Balance at September 30, 2022 includes $139 million recorded as a current liability for amounts expected to be paid within the next 12 months.
The additions to contingent consideration in 2020 relate to the acquisition of Themis (see Note 3). The payments of contingent consideration in 20202022 relate to the Sanofi Pasteur MSD liabilities recorded in connection with the termination of the Sanofi-Pasteur MSD joint venture in 2016.described above.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Other Fair Value Measurements
Some of the Company’s financial instruments, such as cash and cash equivalents, receivables and payables, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature.
The estimated fair value of loans payable and long-term debt (including current portion) at September 30, 2021,2022, was $29.1$25.9 billion compared with a carrying value of $26.4$30.4 billion and at December 31, 2020,2021, was $36.0$35.7 billion compared with a carrying value of $31.8$33.1 billion. Fair value was estimated using recent observable market prices and would be considered Level 2 in the fair value hierarchy.
Concentrations of Credit Risk
On an ongoing basis, the Company monitors concentrations of credit risk associated with corporate and government 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 Company’s investment policy guidelines.
The majority of the Company’s accounts receivable arise from product sales in the U.S., Europe and China and are primarily due from drug wholesalers and retailers, hospitals and government agencies, managed health care providers and pharmacy benefit managers.agencies. The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in their credit profile. The Company also continues to monitor global economic conditions, including the volatility associated with international sovereign economies, and associated impacts on the financial markets and its business.
The Company has accounts receivable factoring agreements with financial institutions in certain countries to sell accounts receivable. The Company factored $2.4$2.3 billion and $2.1$2.8 billion of accounts receivable atas of September 30, 20212022 and December 31, 2020,2021, respectively, under these factoring arrangements, which reduced outstanding accounts receivable. The cash received from the financial institutions is reported within operating activities in the Condensed Consolidated Statement of Cash Flows. In certain of these factoring arrangements, for ease of administration, the Company will collect customer payments related to the factored receivables, which it then remits to the financial institutions. As of September 30, 2022 and December 31, 2021, the Company had collected $55 million and $62 million, respectively, on behalf of the financial institutions, which is reflected as restricted cash in Other current assets and the related obligation to remit the cash within Accrued and other current liabilities. The Company remitted the cash to the financial institutions in October 2022 and January 2022, respectively. The net cash flows relatingrelated to these collections are reported as financing activities in the Condensed Consolidated Statement of Cash Flows. The cost of factoring such accounts receivable was de minimis.
Derivative financial instruments are executed under International Swaps and Derivatives Association master agreements. The master agreements with several of the Company’s 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 Company’s credit rating, and the credit rating of the counterparty. Cash collateral received by the Company from various counterparties was $65$794 million and $164 million at September 30, 2021.2022 and December 31, 2021, respectively. The obligation to return such collateral is recorded in Accrued and other current liabilities. Cash collateral advanced by the Company to counterparties was $36 million at December 31, 2020.
7. Inventories
Inventories consisted of:
| ($ in millions) | ($ in millions) | September 30, 2021 | | December 31, 2020 | ($ in millions) | September 30, 2022 | | December 31, 2021 |
Finished goods | Finished goods | $ | 1,628 | | | $ | 1,610 | | Finished goods | $ | 1,683 | | | $ | 1,747 | |
Raw materials and work in process | Raw materials and work in process | 6,135 | | | 5,949 | | Raw materials and work in process | 6,532 | | | 6,220 | |
Supplies | Supplies | 190 | | | 146 | | Supplies | 227 | | | 196 | |
Total (approximates current cost) | Total (approximates current cost) | 7,953 | | | 7,705 | | Total (approximates current cost) | 8,442 | | | 8,163 | |
Increase (decrease) to LIFO cost | 23 | | | (81) | | |
Decrease to LIFO cost | | Decrease to LIFO cost | (187) | | | (16) | |
| | $ | 7,976 | | | $ | 7,624 | | | $ | 8,255 | | | $ | 8,147 | |
Recognized as: | Recognized as: | | Recognized as: | |
Inventories | Inventories | $ | 5,603 | | | $ | 5,554 | | Inventories | $ | 5,614 | | | $ | 5,953 | |
Other assets | Other assets | 2,373 | | | 2,070 | | Other assets | 2,641 | | | 2,194 | |
Amounts recognized as Other Assets are comprised almost entirely of raw materials and work in process inventories. At September 30, 20212022 and December 31, 2020,2021, these amounts included $1.9$2.2 billion and $1.8$1.9 billion, respectively, of inventories not expected to be sold within one year. In addition, these amounts included $519$417 million and $279$256 million at September 30, 20212022 and December 31, 2020,2021, respectively, of inventories produced in preparation for product launches.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
8. GoodwillOther Intangibles
In the third quarter of 2022, the Company recorded $887 million of impairment charges within Research and Intangibles
Indevelopment expenses related to intangible assets obtained in connection with the spin-off2020 acquisition of Organon (see Note 2)ArQule, Inc. Of this amount, $807 million represents an in-process research and development (IPR&D) impairment charge related to nemtabrutinib (MK-1026), goodwilla novel, oral BTK inhibitor currently being evaluated for the treatment of B-cell malignancies. Following discussions with regulatory authorities in the third quarter, the development period for nemtabrutinib was reduced by $1.4extended, which constituted a triggering event that required the evaluation of the nemtabrutinib intangible asset for impairment. The Company estimated the current fair value of nemtabrutinib utilizing an income approach which calculates the present value of projected future cash flows. The market participant assumptions used to derive the forecasted cash flows were updated to reflect a delay in the anticipated launch date for nemtabrutinib, which resulted in lower cumulative revenue forecasts and a reduction in the estimated fair value. The revised estimated fair value of nemtabrutinib when compared with its related carrying value resulted in the IPR&D impairment charge noted above. The remaining IPR&D intangible asset related to nemtabrutinib is $1.2 billion. Additionally, other intangibles, on a net basis, were reduced by $519 million, including productsIf the assumptions used to estimate the fair value of nemtabrutinib prove to be incorrect and products rightsthe development of $394 millionnemtabrutinib does not progress as anticipated thereby adversely affecting projected future cash flows, the Company may record an additional impairment charge in the future and licenses of $125 million.such charge could be material.
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 certain additional matters including governmental and environmental matters. In the opinion of the Company, it is unlikely that the resolution of these matters will be material to the Company’s financial condition, results of operations or cash flows.
Given the nature of the litigation discussed below and the complexities involved in these matters, the Company is unable to reasonably estimate a possible loss or range of possible loss for such matters until the Company knows, among other factors, (i) what claims, if any, will survive dispositive motion practice, (ii) the extent of the claims, including the size of any potential class, particularly when damages are not specified or are indeterminate, (iii) how the discovery process will affect the litigation, (iv) the settlement posture of the other parties to the litigation and (v) any other factors that may have a material effect on the litigation.
The Company records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. For product liability claims, a portion of the overall accrual is actuarially determined and considers such factors as past experience, number of claims reported and estimates of claims incurred but not yet reported. Individually significant contingent losses are accrued when probable and reasonably estimable. Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable.
The Company’s decision to obtain insurance coverage is dependent on market conditions, including cost and availability, existing at the time such decisions are made. The Company has evaluated its risks and has determined that the cost of obtaining product liability insurance outweighs the likely benefits of the coverage that is available and, as such, has no insurance for most product liabilities.
Product Liability Litigation
Fosamax
As previously disclosed, Merck is a defendant in product liability lawsuits in the U.S. involving Fosamax (Fosamax (alendronate sodium) (Fosamax Litigation). As of September 30, 2021,2022, approximately 3,4703,450 cases are pending against Merck in either a federal multidistrict litigation (Femur Fracture MDL) or state court. Plaintiffs in the vast majority of these cases generally allege that they sustained femur fractures and/or other bone injuries (Femur Fractures) in association with the use of Fosamax.Fosamax.
In March 2014, the Femur Fracture MDL court dismissed with prejudice approximately 650 cases on preemption grounds. Plaintiffs in approximately 515 of those cases appealed that decision to the U.S. Court of Appeals for the Third Circuit (Third Circuit). In March 2017, the Third Circuit issued a decision reversing the Femur Fracture MDL court’s preemption ruling and remanding the appealed cases back to the Femur Fracture MDL court. In May 2019, the U.S. Supreme Court decided that the Third Circuit had incorrectly concluded that the issue of preemption should be resolved by a jury, and accordingly vacated the judgment of the Third Circuit and remanded the proceedings back to the Third Circuit to address the issue in a manner consistent with the Supreme Court’s opinion. In November 2019, the Third Circuit remanded the cases back to the District Court in order to allow that court to determine in the first instance whether the plaintiffs’ state law claims are preempted by federal law under the standards described by the Supreme Court in its opinion. Briefing on the issue is closed, and the parties await the decision ofOn March 23, 2022, the District Court.Court granted Merck’s motion and ruled that plaintiffs’ failure to warn claims are preempted as a matter of law to the extent they
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
assert that Merck should have added a warning or precaution regarding atypical femur fractures prior to September 2010. Plaintiffs have indicated that they do not intend to move forward with any other claims at this point and intend to appeal the District Court’s preemption ruling to the Third Circuit.
Discovery is presently stayed in the Femur Fracture MDL and in the state court in California.MDL. As part of the spin-off of Organon, Organon is required to indemnify Merck for all liabilities relating to, arising from, or resulting from the Fosamax Litigation.
Januvia/Janumet
As previously disclosed, Merck is a defendant in product liability lawsuits in the U.S. involving Januvia and/or Janumet. As of September 30, 2021, Merck is aware of approximately 730 product users alleging that Januvia(sitagliptin) and/or Janumet caused the development of pancreatic cancer(sitagliptin and other injuries.metformin HCl).
Most claims have beenwere filed in multidistrict litigation before the U.S. District Court for the Southern District of California (MDL). OnIn March 9, 2021, the MDL Courtcourt issued an omnibus order granting defendants’ summary judgment motions based on preemption and failure to establish general causation, as well as granting defendants’ motions to exclude
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
plaintiffs’ expert witnesses. The plaintiffs appealed that order. Since that time, more than half of these claims have been dismissed with prejudice as to Merck, and onin October 5, 2021, the U.S. Court of Appeals for the Ninth Circuit dismissed the appeal as to Merck and two of its codefendants. The MDL court’s judgment is now final and no longer appealable with respect to remaining claims.
Outside of the MDL, the majority of claims have beenwere filed in coordinated proceedings before the Superior Court of California, County of Los Angeles (California State Court). On April 6, 2021, the court in California issued an omnibus order granting defendants’ summary judgment motions and also granting defendants’ motions to exclude plaintiffs’ expert witnesses.
As On May 31, 2022, the court entered judgment in favor of September 30, 2021, 6 product users haveMerck as to all of the claims pending against Merck in state courts other than California, including Illinois. In June 2017, the Illinois trial court denied Merck’s motion for summary judgment based on federal preemption. Merck appealed, and the Illinois appellate court affirmed in December 2018. Merck filed a petition for leave to appeal to the Illinois Supreme Court in February 2019. In April 2019, the Illinois Supreme Court stayed consideration of the pending petition to appeal until the U.S. Supreme Court issued its opinion in Merck Sharp & Dohme Corp. v. Albrecht (relating to the Fosamax matter discussed above). Merck filed the opinion in Albrecht with the Illinois Supreme Court in June 2019. The petition for leave to appeal was decided in September 2019, in which the Illinois Supreme Court directed the intermediate appellate court to reconsider its earlier ruling. The Illinois Appellate Court issued a favorable decision concluding, consistent with Albrecht, that preemption presents a legal question to be resolved by the court. In May 2020, the Illinois Appellate Court issued a mandate to the state trial court, which, as of September 30, 2021, had not scheduled a case management conference or otherwise taken action.jurisdiction.
In addition to the claims noted above, the Company has agreed to toll the statute of limitations for approximately 50 additional claims. The Company intends to continue defending against any remaining lawsuits.
Gardasil/Gardasil 9
Merck is a defendant in product liability lawsuits in the U.S. involving Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) and Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant). As of September 30, 2022, approximately 65 cases were filed and pending against Merck in either federal or state court. In these actions, plaintiffs allege, among other things, that they suffered various personal injuries after vaccination with Gardasil or Gardasil 9, with postural orthostatic tachycardia syndrome as a predominate alleged injury. In August 2022, the Judicial Panel on Multidistrict Litigation ordered that Gardasil/Gardasil 9 product liability cases pending in federal courts nationwide be transferred to Judge Robert J. Conrad in the Western District of North Carolina for coordinated pre-trial proceedings. There are fewer than 15 product liability cases pending outside the U.S., including one purported class action in Colombia.
Governmental Proceedings
As previously disclosed, from time to time, the Company’s subsidiaries in China have received and may continue to receive inquiries regarding their operations from various Chinese governmental agencies. Some of these inquiries may be related to matters involving other multinational pharmaceutical companies, as well as Chinese entities doing business with such companies. The Company’s policy is to cooperate with these authorities and to provide responses as appropriate.
As previously disclosed, from time to time, the Company receives inquiries and is the subject of preliminary investigation activities from competition and other governmental authorities in markets outside the U.S. These authorities may include regulators, administrative authorities, and law enforcement and other similar officials, and these preliminary investigation activities may include site visits, formal or informal requests or demands for documents or materials, inquiries or interviews and similar matters. Certain of these preliminary inquiries or activities may lead to the commencement of formal proceedings. Should those proceedings be determined adversely to the Company, monetary fines and/or remedial undertakings may be required.
Commercial and Other Litigation
Zetia Antitrust Litigation
As previously disclosed, Merck, MSD, Schering Corporation, Schering-Plough Corporation, and MSP Singapore Company LLC (collectively, the Merck Defendants) are defendants in putative class action and opt-outa number of lawsuits filed in 2018 on behalf of direct and indirect purchasers of Zetia (ezetimibe) alleging violations of federal and state antitrust laws, as well as other state statutory and common law causes of action. The cases have beenwere consolidated for pretrial purposes in a federal multidistrict litigation (the Zetia MDL) before Judge Rebecca Beach Smith in the Eastern District of Virginia. In December 2018, the court denied the Merck Defendants’ motions
Notes to dismiss or stay the direct purchaser putative class actions pending bilateral arbitration. In August 2019, the district court adopted in full the report and recommendation of the magistrate judge with respect to the Merck Defendants’ motions to dismiss on non-arbitration issues, thereby granting in part and denying in part Merck Defendants’ motions to dismiss. In addition, in June 2019, the representatives of the putative direct purchaser class filed an amended complaint, and in August 2019, retailer opt-out plaintiffs filed an amended complaint. In December 2019, the district court granted the Merck Defendants’ motion to dismiss to the extent the motion sought dismissal of claims for overcharges paid by entities that purchased generic ezetimibe from Par Pharmaceutical, Inc. (Par Pharmaceutical) and dismissed any claims for such overcharges. Condensed Consolidated Financial Statements (unaudited) (continued)
In November 2019, the direct purchaser plaintiffs and the indirect purchaser plaintiffs filed motions for class certification. In August 2020, the district court granted in part the direct purchasers’ motion for class certification and certified a class of 35 direct purchasers and, in November 2020, the U.S. Court of Appeals for the Fourth Circuit granted the Merck Defendants’ motion for permission to appeal the district court’s order.purchasers. In August 2021, the Fourth Circuit vacated the district court’s class certification order and remanded for further proceedings consistent with the court’s ruling. In September 2021, the direct purchaser plaintiffs filed a renewed motion for class certification and briefing regarding that motion is pending.
In August 2020, the Merck Defendants filed a motion for summary judgment and other motions, and plaintiffs filed a motion for partial summary judgment, and other motions. Those motions are now fully briefed, and the court has heard
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
argument on certain of the motions. The court may hold additional hearings on the other motions. Trial in this matter has been adjourned.
Also in August 2020,certification. On January 25, 2022, the magistrate judge recommended that the district court grantdeny the motion for class certificationcertification. On February 8, 2022, the direct purchaser plaintiffs filed byobjections to the putative indirectrecommendation. On April 13, 2022, the district court denied the direct purchaser class. The Merck Defendants objected to this report and recommendation.plaintiffs’ renewed motion for class certification. In August 2021, the district court overruled the Merck Defendants’ objections to the report and recommendation and granted certification of a class of indirect purchasers.
In September2020 and 2021, the Merck Defendants petitioned to appeal the class certification decision to the Fourth Circuit. The Fourth Circuit denied that petition on September 30, 2021.
In September 2020, United Healthcare Services, Inc., Humana Inc., Centene Corporation and others, and Kaiser Foundation Health Plan, Inc. (collectively, the Insurer Plaintiffs), each filed a lawsuit in a jurisdiction outside of the U.S. District Court for theEastern District of MinnesotaVirginia against the Merck Defendants and others, (the UHC Action). The UHC Action makesmaking similar allegations as those made in the Zetia class action. In September 2020, the U.S. Judicial Panel on Multidistrict Litigation MDL, as well as additional allegations about Vytorin. These cases have been transferred the case to the Eastern District of Virginia to proceed with the multidistrict Zetia litigation already in progress. Defendants have MDL.
On February 9, 2022, the Insurer Plaintiffs filed a motion to dismiss.
In December 2020, Humana Inc. filed a lawsuit in the Superior Court of the State of California, County of San Francisco, against Merck and others, alleging defendants violated state antitrust laws in multiple states. Also, in December 2020, Centene Corporation and others filed a lawsuit in the Superior Court of the State of California, County of San Francisco, against the same defendants as Humana. Both lawsuits allege similar anticompetitive acts to those alleged in the Zetia class action. In July 2021, the California Court ruled on defendants’ Motion to Quash for lack of personal jurisdiction, granting the motion as to the out-of-state claims against defendants, and ordering limited jurisdictional discovery with regard to the California claims. In September 2021, the parties reached an agreement that Humana and Centene would file their claims in New Jersey federal court, seek a transfer of those claims to the multidistrict Zetia litigation already in progress, and subsequently dismiss the actions previously filed in California. The parties jointly sought a stay of the Superior Court action, pending filing of the federal action. The Superior Court granted the stay on September 17, 2021.
Also, on July 16, 2021, Humana and Centene filed actions againstamended complaints. On March 2, 2022, the Merck Defendants, in New Jersey in the Bergen County Superior Court, re-asserting the claims that were dismissed in their California action. Those complaints have not yet been served, and Humana and Centene have agreedjointly with other defendants, moved to dismiss certain aspects of the Insurer Plaintiffs’ complaints, including any claims for Vytorin damages. That motion to dismiss the Vytorin-related claims is still pending.
In April 2022, the direct purchaser plaintiffs moved for an order setting a deadline for direct purchasers of Zetia not currently parties to the case to file cases against defendants in order for those actions once theycases to be coordinated for trial with the existing direct purchaser plaintiffs and other MDL plaintiff groups. The court granted that motion, setting a deadline of June 30, 2022 for unnamed direct purchasers to file claims. On June 30, 2022, 23 new entities, many related, brought new complaints against defendants or otherwise sought to intervene.
On September 2, 2022, the Magistrate Judge issued a Report and Recommendation denying the Merck Defendants’ and Glenmark Defendants’ motions for summary judgment. Defendants have filed their complaints in New Jersey federal court.objected to the Report and Recommendation, and are awaiting a final decision from Judge Smith. The court has scheduled trial for all plaintiffs other than the Insurer Plaintiffs for April 2023.
340B Program Litigation
In June 2021, Kaiser Foundation Health Plan, Inc. similarlyMerck has filed a lawsuitcomplaint in the Superior Court of the State of California, County of San Francisco, against the same defendants as Humana and Centene. The Kaiser lawsuit alleges similar anticompetitive acts to those alleged in the Zetia class action. The Kaiser action was removed to the U.S. District Court for the Northern District of California on July 16, 2021. InColumbia to challenge the letter Merck received from the Health Resources and Services Administration (HRSA) in May 2022 regarding Merck’s 340B Program integrity initiative. HRSA’s letter to Merck asserts that Merck is in violation of the 340B statute. HRSA further claims that continued failure to provide the 340B price to covered entities using contract pharmacies may result in civil monetary penalties for each instance of alleged overcharging, in addition to repayment for any instance of overcharging. The letter is very similar to letters HRSA has sent to other manufacturers, which letters have been held to be unlawful by multiple federal courts. Merck disagrees with HRSA’s assertion. Merck remains committed to the 340B Program and to providing 340B discounts to eligible covered entities. Merck’s 340B Program integrity initiative is consistent with the requirements of the 340B statute and is intended to ensure the integrity and sustainability of the 340B statute by reducing prohibited duplicate discounts and diversion and putting patients back at the center of the program. Merck continues to offer all of the Company’s covered outpatient drugs to all 340B covered entities for purchase at or below the 340B ceiling price. On September 2021,13, 2022, the U.S. Judicial Panel on Multidistrict Litigation transferredcourt stayed the case topending the Eastern District of Virginia to proceed with the multidistrictD.C. Circuit’s ruling in ZetiaNovartis Pharmaceuticals Corp. v. Johnson and United Therapeutics Corp. v. Johnson litigation already in progress..
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file abbreviated New Drug Applications (NDAs) with the FDA seeking to market generic forms of the Company’s 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. Similar lawsuits defending the Company’s patent rights may exist in other countries. The Company intends to vigorously defend its patents, which it believes are valid, against infringement by 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 and, with respect to products acquired through acquisitions accounted for as business combinations, potentially significant intangible asset impairment charges.
Bridion — BetweenAs previously disclosed, between January and November 2020, the Company received multiple Paragraph IV Certification Letters under the Hatch-Waxman Act notifying the Company that generic drug companies have filed applications to the FDA seeking pre-patent expiry approval to sell generic versions of Bridion (sugammadex) Injection. In March, April and December 2020, the Company filed patent infringement lawsuits in the U.S. District Courts for the District of New Jersey and the Northern District of West Virginia against those generic companies. All actions in the District of New Jersey have been consolidated. These lawsuits, which assert one or more patents covering sugammadex and methods of using sugammadex, automatically stay FDA approval of the generic applications until June 2023 or until adverse court decisions, if any, whichever may occur earlier.
Mylan Pharmaceuticals Inc., Mylan API US LLC, and Mylan Inc. (Mylan) have filed motions to dismiss in the District of New Jersey for lack of venue and failure to state a claim against certain defendants, and in the Northern District of West Virginia for failure to state a claim against certain defendants. The New Jersey motion has not yet been decided, and the West Virginia action is stayed pending resolution of the New Jersey motion.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
any, whichever may occur earlier. The West Virginia case was jointly dismissed with prejudice on August 8, 2022 in favor of proceeding in New Jersey. The remaining defendants in the New Jersey action have stipulated to infringement of the asserted claims and have stated they are withdrawing all remaining claims and defenses other than a defense seeking to shorten the patent term extension of the sugammadex patent to December 2022. In light of this, the U.S. District Court for the District of New Jersey cancelled the scheduled trial and scheduled a one-day trial on December 19, 2022 on this remaining patent term extension calculation defense.
The Company has settled with 3five generic companies providing that these generic companies can bring their generic versions of Bridion to the market in January 2026 (which may be delayed by any applicable pediatric exclusivity) or earlier under certain circumstances. The Company has agreed to stay the lawsuit filed against two generic companies, which in exchange agreed to be bound by a judgment on the merits of the consolidated action in the District of New Jersey. One of the generic companies in the consolidated action requested dismissal of the action against it and the Company did not oppose this request, which was subsequently granted by the court. The Company does not expect this company to bring its generic version of Bridion to the market before January 2026 or later, depending on any applicable pediatric exclusivity, unless the Company receives an adverse court decision.
Januvia, Janumet, Janumet XR — As previously disclosed, the FDA has granted pediatric exclusivity with respect to Januvia, Janumet, and JanumetJanumet XR (sitagliptin and metformin HCl extended-release), which provides a further six months of exclusivity in the U.S. beyond the expiration of all patents listed in the FDA’s Orange Book. Adding this exclusivity to the term of the key patent protection extends exclusivity on these products to January 2023. The Company anticipates that sales of Januvia and Janumet in the U.S. will decline significantly after this loss of market exclusivity. However, Januvia, Janumet, and Janumet XR contain sitagliptin phosphate monohydrate and the Company has another patent covering certain phosphate salt and polymorphic forms of sitagliptin that expires in May 2027, including pediatric exclusivity (2027 salt/polymorph patent), which, if determined to be valid, would preclude generic manufacturers from making sitagliptin phosphate salt and polymorphic forms until 2027 with the expiration of that patent, plus pediatric exclusivity.. In 2019, Par Pharmaceutical filed suit against the Company in the U.S. District Court for the District of New Jersey, seeking a declaratory judgment of invalidity of the 2027 salt/polymorph patent. In response, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Par Pharmaceutical and additional companies that also indicated an intent to market generic versions of Januvia, Janumet, and Janumet XR following expiration of key patent protection, but prior to the expiration of the 2027 salt/polymorph patent, and a later granted patent owned by the Company covering the Janumet formulation where its term plus the pediatric exclusivity ends in 2029. The Company also filed a patent infringement lawsuit against Mylan in the Northern District of West Virginia. The Judicial Panel on Multidistrict Litigation entered an order transferring the Company’s lawsuit against Mylan to the U.S. District Court for the District of Delaware for coordinated and consolidated pretrial proceedings with the other cases pending in that district.
Prior to the beginning of the scheduled October 2021 trial in the U.S. District Court for the District of Delaware on invalidity issues, the Company settled with all defendants scheduled to participate in that trial. In the Company’s case against Mylan, a bench trial was held in December 2021 in the U.S. District Court for the Northern District of West Virginia, and the closing arguments were held on April 13, 2022. On September 21, 2022, the District Court for the Northern District of West Virginia issued a decision in the Company’s favor, upholding all asserted patent claims. Mylan (now Viatris) has scheduled a five-day bench trial in December 2021.appealed to the U.S. Court of Appeals for the Federal Circuit.
In total, the Company has settled with 1622 generic companies providing that these generic companies can bring their generic versions of Januvia and Janumet to the market in May 2026 or earlier under certain circumstances, and their generic versions of Janumet XR to the market in July 2026 or earlier under certain circumstances.
Additionally, in 2019, Mylan filed a petition for Inter Partesinter partes Reviewreview (IPR) at the U.S. Patent and Trademark Office (USPTO) seeking invalidity of some, but not all, of the claims of the 2027 salt/polymorph patent. The USPTO instituted IPR proceedings in May 2020, finding a reasonable likelihood that the challenged claims are not valid. A trial was held in February 2021 and a final decision was rendered in May 2021, holding that all of the challenged claims were not invalid. Mylan has appealed the USPTO’s decision to the U.S. Court of Appeals for the Federal Circuit.Circuit, and a hearing was held on August 2, 2022. On September 29, 2022, the Court of Appeals for the Federal Circuit ruled in the Company’s favor, upholding the USPTO’s decision.
OnIn March 1, 2021, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd. (collectively, Zydus).In that lawsuit, the Company alleged infringement of the 2027 salt/polymorph patent based on the filing of Zydus’s application seeking approval under 21 U.S.C. § 355(b)(2) of its sitagliptin tablets.The While the U.S. District Court for the District of Delaware hasoriginally set a three-day bench trial in this matter beginning on October 31, 2022.2022, the trial date has been moved to January 9, 2023.
In Germany, genericGeneric companies have sought the revocation of the Supplementary Protection Certificate (SPC) for Janumet. Ifin a number of European countries. In February 2022, a Finnish court referred certain questions to the generic companies are successful,Court of Justice of the European Union that could determine the validity of the Janumet could lose market exclusivitySPCs in Germany at the same time as the expiry of Januvia pediatric market exclusivity in September 2022. A hearing was held inEurope. In June 2021, and thea German court decided that the SPC for Janumet is invalid, which decision the Company has appealed. Challenges toThe validity of the JanumetSPC have also occurredwas upheld in the following European countries: Austria, Czech Republic in March 2022 in a first instance decision, which has been appealed. In June 2022, a Romanian court decided
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
that the SPC for Janumet was invalid in a first instance decision. In August 2022, the validity of the SPC for Janumet was upheld in Sweden in a first instance decision, which decision has been appealed. MSD has filed injunction actions against generic companies in Belgium, Finland, France, Hungary, Italy, Portugal, Romania, Slovakia,Greece, Ireland and Sweden.Portugal. In September 2022, the following decisions were issued: ex-parte preliminary injunctions were granted in Finland; a preliminary injunction was granted in France, and the validity of the SPC and the associated patent were held to be prima facie valid in these proceedings; and a temporary restraining order was granted in Greece. In October 2022, requests for ex parte preliminary injunctions were refused in Portugal.
Other Litigation
There are various other pending legal proceedings involving the Company, principally product liability and intellectual property lawsuits. While it is not feasible to predict the outcome of such proceedings, in the opinion of the Company, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to the Company’s financial condition, results of operations or cash flows either individually or in the aggregate.
Legal Defense Reserves
Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. Some of the significant factors considered in the review of these legal defense reserves are as follows: the actual costs incurred by the Company; the development of the Company’s legal defense strategy and structure in light of the
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
scope of its litigation; 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 associated litigation. The amount of legal defense reserves as of September 30, 20212022 and December 31, 20202021 of approximately $225$230 million and $235 million, respectively, represents the Company’s best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials and other events that could arise in the course of its litigation could affect the ultimate amount of legal defense costs to be incurred by the Company. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth, it believes it would be appropriate to do so.
10. Equity
| | | Three Months Ended September 30, | | Three Months Ended September 30, |
| | Common Stock | Other Paid-In Capital | Retained Earnings | Accumulated Other Comprehensive Loss | Treasury Stock | Non- controlling Interests | Total | | Common Stock | Other Paid-In Capital | Retained Earnings | Accumulated Other Comprehensive Loss | Treasury Stock | Non- controlling Interests | Total |
($ and shares in millions except per share amounts) | ($ and shares in millions except per share amounts) | Shares | Par Value | Shares | Cost | ($ and shares in millions except per share amounts) | Shares | Par Value | Shares | Cost |
Balance at July 1, 2020 | 3,577 | | $ | 1,788 | | $ | 39,373 | | $ | 49,724 | | $ | (6,393) | | 1,048 | | $ | (56,850) | | $ | 102 | | $ | 27,744 | | |
Net income attributable to Merck & Co., Inc. | — | | — | | — | | 2,941 | | — | | — | | — | | — | | 2,941 | | |
Other comprehensive income, net of taxes | — | | — | | — | | — | | 10 | | — | | — | | — | | 10 | | |
Cash dividends declared on common stock ($0.61 per share) | — | | — | | — | | (1,558) | | — | | — | | — | | — | | (1,558) | | |
Share-based compensation plans and other | — | | — | | 116 | | — | | — | | (1) | | 35 | | — | | 151 | | |
Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 4 | | 4 | | |
Distributions attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | (22) | | (22) | | |
Balance at September 30, 2020 | 3,577 | | $ | 1,788 | | $ | 39,489 | | $ | 51,107 | | $ | (6,383) | | 1,047 | | $ | (56,815) | | $ | 84 | | $ | 29,270 | | |
Balance at July 1, 2021 | Balance at July 1, 2021 | 3,577 | | $ | 1,788 | | $ | 44,039 | | $ | 48,777 | | $ | (4,628) | | 1,044 | | $ | (56,682) | | $ | 94 | | $ | 33,388 | | Balance at July 1, 2021 | 3,577 | | $ | 1,788 | | $ | 44,039 | | $ | 48,777 | | $ | (4,628) | | 1,044 | | $ | (56,682) | | $ | 94 | | $ | 33,388 | |
Net income attributable to Merck & Co., Inc. | Net income attributable to Merck & Co., Inc. | — | | — | | — | | 4,567 | | — | | — | | — | | — | | 4,567 | | Net income attributable to Merck & Co., Inc. | — | | — | | — | | 4,567 | | — | | — | | — | | — | | 4,567 | |
Other comprehensive income, net of taxes | Other comprehensive income, net of taxes | — | | — | | — | | — | | 38 | | — | | — | | — | | 38 | | Other comprehensive income, net of taxes | — | | — | | — | | — | | 38 | | — | | — | | — | | 38 | |
Cash dividends declared on common stock ($0.65 per share) | Cash dividends declared on common stock ($0.65 per share) | — | | — | | — | | (1,653) | | — | | — | | — | | — | | (1,653) | | Cash dividends declared on common stock ($0.65 per share) | — | | — | | — | | (1,653) | | — | | — | | — | | — | | (1,653) | |
Treasury stock shares purchased | Treasury stock shares purchased | — | | — | | — | | — | | — | | 8 | | (583) | | — | | (583) | | Treasury stock shares purchased | — | | — | | — | | — | | — | | 8 | | (583) | | — | | (583) | |
Share-based compensation plans and other | Share-based compensation plans and other | — | | — | | 110 | | — | | — | | — | | 21 | | — | | 131 | | Share-based compensation plans and other | — | | — | | 110 | | — | | — | | — | | 21 | | — | | 131 | |
Net income attributable to noncontrolling interests | Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 4 | | 4 | | Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 4 | | 4 | |
Distributions attributable to noncontrolling interests | Distributions attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | (29) | | (29) | | Distributions attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | (29) | | (29) | |
Balance at September 30, 2021 | Balance at September 30, 2021 | 3,577 | | 1,788 | | 44,149 | | 51,691 | | (4,590) | | 1,052 | | (57,244) | | 69 | | 35,863 | | Balance at September 30, 2021 | 3,577 | | $ | 1,788 | | $ | 44,149 | | $ | 51,691 | | $ | (4,590) | | 1,052 | | $ | (57,244) | | $ | 69 | | $ | 35,863 | |
Balance at July 1, 2022 | | Balance at July 1, 2022 | 3,577 | | $ | 1,788 | | $ | 44,115 | | $ | 58,437 | | $ | (4,327) | | 1,044 | | $ | (56,770) | | $ | 75 | | $ | 43,318 | |
Net income attributable to Merck & Co., Inc. | | Net income attributable to Merck & Co., Inc. | — | | — | | — | | 3,248 | | — | | — | | — | | — | | 3,248 | |
Other comprehensive loss, net of taxes | | Other comprehensive loss, net of taxes | — | | — | | — | | — | | (416) | | — | | — | | — | | (416) | |
Cash dividends declared on common stock ($0.69 per share) | | Cash dividends declared on common stock ($0.69 per share) | — | | — | | — | | (1,757) | | — | | — | | — | | — | | (1,757) | |
Share-based compensation plans and other | | Share-based compensation plans and other | — | | — | | 128 | | — | | — | | — | | 12 | | — | | 140 | |
Net income attributable to noncontrolling interests | | Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 5 | | 5 | |
Distributions attributable to noncontrolling interests | | Distributions attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | (14) | | (14) | |
Balance at September 30, 2022 | | Balance at September 30, 2022 | 3,577 | | $ | 1,788 | | $ | 44,243 | | $ | 59,928 | | $ | (4,743) | | 1,044 | | $ | (56,758) | | $ | 66 | | $ | 44,524 | |
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
| | | Nine Months Ended September 30, | | Nine Months Ended September 30, |
| | Common Stock | Other Paid-In Capital | Retained Earnings | Accumulated Other Comprehensive Loss | Treasury Stock | Non- controlling Interests | Total | | Common Stock | Other Paid-In Capital | Retained Earnings | Accumulated Other Comprehensive Loss | Treasury Stock | Non- controlling Interests | Total |
($ and shares in millions except per share amounts) | ($ and shares in millions except per share amounts) | Shares | Par Value | Shares | Cost | ($ and shares in millions except per share amounts) | Shares | Par Value | Shares | Cost |
Balance at January 1, 2020 | 3,577 | | $ | 1,788 | | $ | 39,660 | | $ | 46,602 | | $ | (6,193) | | 1,038 | | $ | (55,950) | | $ | 94 | | $ | 26,001 | | |
Net income attributable to Merck & Co., Inc. | — | | — | | — | | 9,161 | | — | | — | | — | | — | | 9,161 | | |
Other comprehensive loss, net of taxes | — | | — | | — | | — | | (190) | | — | | — | | — | | (190) | | |
Cash dividends declared on common stock ($1.83 per share) | — | | — | | — | | (4,656) | | — | | — | | — | | — | | (4,656) | | |
Treasury stock shares purchased | — | | — | | — | | — | | — | | 16 | | (1,281) | | — | | (1,281) | | |
Share-based compensation plans and other | — | | — | | (171) | | — | | — | | (7) | | 416 | | — | | 245 | | |
Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 12 | | 12 | | |
Distributions attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | (22) | | (22) | | |
Balance at September 30, 2020 | 3,577 | | 1,788 | | 39,489 | | 51,107 | | (6,383) | | 1,047 | | (56,815) | | 84 | | 29,270 | | |
Balance at January 1, 2021 | Balance at January 1, 2021 | 3,577 | | $ | 1,788 | | $ | 39,588 | | $ | 47,362 | | $ | (6,634) | | 1,047 | | $ | (56,787) | | $ | 87 | | $ | 25,404 | | Balance at January 1, 2021 | 3,577 | | $ | 1,788 | | $ | 39,588 | | $ | 47,362 | | $ | (6,634) | | 1,047 | | $ | (56,787) | | $ | 87 | | $ | 25,404 | |
Net income attributable to Merck & Co., Inc. | Net income attributable to Merck & Co., Inc. | — | | — | | — | | 9,291 | | — | | — | | — | | — | | 9,291 | | Net income attributable to Merck & Co., Inc. | — | | — | | — | | 9,291 | | — | | — | | — | | — | | 9,291 | |
Other comprehensive income, net of taxes | Other comprehensive income, net of taxes | — | | — | | — | | — | | 1,595 | | — | | — | | — | | 1,595 | | Other comprehensive income, net of taxes | — | | — | | — | | — | | 1,595 | | — | | — | | — | | 1,595 | |
Cash dividends declared on common stock ($1.95 per share) | Cash dividends declared on common stock ($1.95 per share) | — | | — | | — | | (4,962) | | — | | — | | — | | — | | (4,962) | | Cash dividends declared on common stock ($1.95 per share) | — | | — | | — | | (4,962) | | — | | — | | — | | — | | (4,962) | |
Treasury stock shares purchased | Treasury stock shares purchased | — | | — | | — | | — | | — | | 11 | | (822) | | — | | (822) | | Treasury stock shares purchased | — | | — | | — | | — | | — | | 11 | | (822) | | — | | (822) | |
Spin-off of Organon & Co. | Spin-off of Organon & Co. | — | | — | | 4,643 | | — | | 449 | | — | | — | | (1) | | 5,091 | | Spin-off of Organon & Co. | — | | — | | 4,643 | | — | | 449 | | — | | — | | (1) | | 5,091 | |
Share-based compensation plans and other | Share-based compensation plans and other | — | | — | | (82) | | — | | — | | (6) | | 365 | | — | | 283 | | Share-based compensation plans and other | — | | — | | (82) | | — | | — | | (6) | | 365 | | — | | 283 | |
Net income attributable to noncontrolling interests | Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 12 | | 12 | | Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 12 | | 12 | |
Distributions attributable to noncontrolling interests | Distributions attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | (29) | | (29) | | Distributions attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | (29) | | (29) | |
Balance at September 30, 2021 | Balance at September 30, 2021 | 3,577 | | 1,788 | | 44,149 | | 51,691 | | (4,590) | | 1,052 | | (57,244) | | 69 | | 35,863 | | Balance at September 30, 2021 | 3,577 | | $ | 1,788 | | $ | 44,149 | | $ | 51,691 | | $ | (4,590) | | 1,052 | | $ | (57,244) | | $ | 69 | | $ | 35,863 | |
Balance at January 1, 2022 | | Balance at January 1, 2022 | 3,577 | | $ | 1,788 | | $ | 44,238 | | $ | 53,696 | | $ | (4,429) | | 1,049 | | $ | (57,109) | | $ | 73 | | $ | 38,257 | |
Net income attributable to Merck & Co., Inc. | | Net income attributable to Merck & Co., Inc. | — | | — | | — | | 11,502 | | — | | — | | — | | — | | 11,502 | |
Other comprehensive loss, net of taxes | | Other comprehensive loss, net of taxes | — | | — | | — | | — | | (314) | | — | | — | | — | | (314) | |
Cash dividends declared on common stock ($2.07 per share) | | Cash dividends declared on common stock ($2.07 per share) | — | | — | | — | | (5,270) | | — | | — | | — | | — | | (5,270) | |
| Share-based compensation plans and other | | Share-based compensation plans and other | — | | — | | 5 | | — | | — | | (5) | | 351 | | — | | 356 | |
Net income attributable to noncontrolling interests | | Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 6 | | 6 | |
Distributions attributable to noncontrolling interests | | Distributions attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | (13) | | (13) | |
Balance at September 30, 2022 | | Balance at September 30, 2022 | 3,577 | | $ | 1,788 | | $ | 44,243 | | $ | 59,928 | | $ | (4,743) | | 1,044 | | $ | (56,758) | | $ | 66 | | $ | 44,524 | |
11. Pension and Other Postretirement Benefit Plans
The Company has defined benefit pension plans covering eligible employees in the U.S. and in certain of its international subsidiaries. The net periodic benefit cost of such plans (including certain costs reported as part of discontinued operations)operations in the first nine months of 2021) consisted of the following components:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2021 | | 2020 | | 2021 | | 2020 | | 2022 | | 2021 | | 2022 | | 2021 |
($ in millions) | ($ in millions) | U.S. | | International | | U.S. | | International | | U.S. | | International | | U.S. | | International | ($ in millions) | U.S. | | International | | U.S. | | International | | U.S. | | International | | U.S. | | International |
Service cost | Service cost | $ | 104 | | | $ | 75 | | | $ | 96 | | | $ | 76 | | | $ | 302 | | | $ | 254 | | | $ | 270 | | | $ | 222 | | Service cost | $ | 91 | | | $ | 66 | | | $ | 104 | | | $ | 75 | | | $ | 289 | | | $ | 213 | | | $ | 302 | | | $ | 254 | |
Interest cost | Interest cost | 102 | | | 33 | | | 107 | | | 35 | | | 305 | | | 92 | | | 323 | | | 102 | | Interest cost | 123 | | | 35 | | | 102 | | | 33 | | | 330 | | | 110 | | | 305 | | | 92 | |
Expected return on plan assets | Expected return on plan assets | (188) | | | (105) | | | (193) | | | (104) | | | (568) | | | (313) | | | (581) | | | (309) | | Expected return on plan assets | (182) | | | (93) | | | (188) | | | (105) | | | (576) | | | (292) | | | (568) | | | (313) | |
Amortization of unrecognized prior service credit | Amortization of unrecognized prior service credit | (9) | | | (3) | | | (12) | | | (3) | | | (29) | | | (12) | | | (37) | | | (9) | | Amortization of unrecognized prior service credit | (8) | | | (3) | | | (9) | | | (3) | | | (24) | | | (10) | | | (29) | | | (12) | |
Net loss amortization | Net loss amortization | 75 | | | 32 | | | 75 | | | 32 | | | 218 | | | 110 | | | 228 | | | 94 | | Net loss amortization | 10 | | | 24 | | | 75 | | | 32 | | | 122 | | | 73 | | | 218 | | | 110 | |
Termination benefits | Termination benefits | 2 | | | — | | | 1 | | | 1 | | | 54 | | | 3 | | | 5 | | | 2 | | Termination benefits | 1 | | | — | | | 2 | | | — | | | 2 | | | 1 | | | 54 | | | 3 | |
Curtailments | Curtailments | (1) | | | — | | | 1 | | | — | | | 15 | | | (27) | | | 4 | | | (1) | | Curtailments | 3 | | | — | | | (1) | | | — | | | 11 | | | — | | | 15 | | | (27) | |
Settlements | Settlements | 139 | | | — | | | 2 | | | — | | | 139 | | | 2 | | | 11 | | | 2 | | Settlements | 79 | | | — | | | 139 | | | — | | | 180 | | | — | | | 139 | | | 2 | |
| | $ | 224 | | | $ | 32 | | | $ | 77 | | | $ | 37 | | | $ | 436 | | | $ | 109 | | | $ | 223 | | | $ | 103 | | | $ | 117 | | | $ | 29 | | | $ | 224 | | | $ | 32 | | | $ | 334 | | | $ | 95 | | | $ | 436 | | | $ | 109 | |
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
The Company provides medical benefits, principally to its eligible U.S. retirees and similar benefits to their dependents, through its other postretirement benefit plans. The net credit of such plans consisted of the following components:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 |
Service cost | Service cost | $ | 11 | | | $ | 13 | | | $ | 37 | | | $ | 39 | | Service cost | $ | 11 | | | $ | 11 | | | $ | 36 | | | $ | 37 | |
Interest cost | Interest cost | 12 | | | 14 | | | 34 | | | 43 | | Interest cost | 11 | | | 12 | | | 34 | | | 34 | |
Expected return on plan assets | Expected return on plan assets | (20) | | | (19) | | | (59) | | | (56) | | Expected return on plan assets | (21) | | | (20) | | | (64) | | | (59) | |
Amortization of unrecognized prior service credit | Amortization of unrecognized prior service credit | (16) | | | (18) | | | (48) | | | (54) | | Amortization of unrecognized prior service credit | (14) | | | (16) | | | (42) | | | (48) | |
Net gain amortization | Net gain amortization | (12) | | | (5) | | | (30) | | | (13) | | Net gain amortization | (11) | | | (12) | | | (32) | | | (30) | |
Termination benefits | Termination benefits | — | | | — | | | 37 | | | — | | Termination benefits | — | | | — | | | — | | | 37 | |
Curtailments | Curtailments | (1) | | | — | | | (29) | | | (1) | | Curtailments | — | | | (1) | | | (1) | | | (29) | |
| | $ | (26) | | | $ | (15) | | | $ | (58) | | | $ | (42) | | | $ | (24) | | | $ | (26) | | | $ | (69) | | | $ | (58) | |
Net periodic benefit cost (credit) for pension and other postretirement benefit plans in the first nine months of 2021 includes expenses for curtailments, settlements and termination benefits provided to certain employees in connection with the spin-off of Organon.
In connection with restructuring actions (see Note 5), termination charges were recorded on pension plans related to expanded eligibility for certain employees exiting Merck. Also, in connection with these restructuring actions,activities, curtailments and settlements were recorded on certain pension plans. In addition, lump sum payments to U.S. pension plan participants triggered a partial settlement resulting in a charge of approximately $125 millioncharges in the third quarter and first nine months of 2022 and 2021. ThisThese partial settlementsettlements triggered a remeasurementremeasurements of some of the Company’s U.S. pension plans. ThisThe third quarter 2022 remeasurement, which was calculated using discount rates and asset values as of September 30, 2021,2022, resulted in a net increase of $160$296 million to net pension liabilities and also resulted in a related adjustment to AOCL. Remeasurements during the first nine months of 2022 have resulted in a net increase of $131 million to net pension liabilities with related adjustments to AOCL.
The components of net periodic benefit cost (credit) other than the service cost component are included in Other (income) expense, net (see Note 12), with the exception of certain amounts for termination benefits, curtailments and settlements, which are recorded in Restructuring costs if the event giving rise to the termination benefits, curtailment or settlement is related to restructuring actions or in Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests if related to the spin-off of Organon (each as noted above).
The transfer of employees to Organon in connection with the spin-off triggered remeasurements of some of the Company’s pension plans. These remeasurements, which were calculated using discount rates and asset values as of the date of the spin-off, resulted in a $1.7 billion reduction to net pension liabilities primarily due to higher discount rates. In addition, $99 million of net pension liabilities were transferred to Organon. The remeasurements and plan transfers also resulted in a related adjustment to AOCL (see Note 15).
12. Other (Income) Expense, Net
Other (income) expense, net, consisted of:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 |
Interest income | Interest income | $ | (7) | | | $ | (9) | | | $ | (27) | | | $ | (48) | | Interest income | $ | (40) | | | $ | (7) | | | $ | (62) | | | $ | (27) | |
Interest expense | Interest expense | 196 | | | 203 | | | 597 | | | 624 | | Interest expense | 244 | | | 196 | | | 727 | | | 597 | |
Exchange losses | Exchange losses | 46 | | | 10 | | | 202 | | | 89 | | Exchange losses | 96 | | | 46 | | | 220 | | | 202 | |
Income from investments in equity securities, net (1) | (683) | | | (360) | | | (1,535) | | | (964) | | |
Net periodic defined benefit plan cost (credit) other than service cost | 40 | | | (88) | | | (159) | | | (259) | | |
Loss (income) from investments in equity securities, net (1) | | Loss (income) from investments in equity securities, net (1) | 371 | | | (683) | | | 1,361 | | | (1,535) | |
Net periodic defined benefit plan (credit) cost other than service cost | | Net periodic defined benefit plan (credit) cost other than service cost | (60) | | | 40 | | | (208) | | | (159) | |
Other, net | Other, net | (42) | | | (68) | | | (85) | | | (79) | | Other, net | (182) | | | (42) | | | (462) | | | (85) | |
| | $ | (450) | | | $ | (312) | | | $ | (1,007) | | | $ | (637) | | | $ | 429 | | | $ | (450) | | | $ | 1,576 | | | $ | (1,007) | |
(1) Includes net realized and unrealized gains and losses from investments in equity securities either owned directly or through ownership interests in investment funds. Unrealized gains and losses from investments that are directly owned are determined at the end of the reporting period, while gains and losses from ownership interests in investment funds are accounted for on a one quarter lag. The Company estimates that gains of approximately $540 million will be recorded in the fourth quarter of 2021 from ownership interests in investment funds.
Interest paid for the nine months ended September 30, 2022 and 2021 was $660 million and 2020 was $570 million, and $605 million, respectively.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
13. Taxes on Income
The effective income tax rates from continuing operations were 13.2%9.2% and 14.0%13.2% for the third quarter of 20212022 and 2020,2021, respectively, and 14.4%11.0% and 15.1%14.4% for the first nine months of 20212022 and 2020,2021, respectively. The effective income tax rates from continuing operations reflect the beneficial impact of foreign earnings. The effective income tax rates from continuing operations in the third quarter and first nine months of 2021 reflect2022 also include the beneficialfavorable impact of net unrealized losses from investments in equity securities and intangible asset impairment charges, which were taxed at the settlement of a foreignU.S. tax matter.rate. The effective income tax rate from continuing operations forin the first nine months of 2021 reflects the unfavorable effect of a charge for the acquisition of Pandion for which no tax benefit was recognized, as well as a net tax benefit of $207 million related to the settlement of certain federal income tax matters as discussed below.
In the first quarter of 2021, the Internal Revenue Service (IRS) concluded its examinations of Merck’s 2015-2016 U.S. federal income tax returns. As a result, the Company was required to make a payment of $190 million (of which $172 million related to Merck continuing operations and $18 million related to Organon discontinued operations). The Company’s reserves for unrecognized tax benefits for the years under examination exceeded the adjustments relating to this examination period and therefore the Company recorded a $236 million net tax benefit in the first nine months of 2021 (of which $207 million related to Merck continuing operations and $29 million related to Organon discontinued operations). This net benefit reflects reductions in reserves for unrecognized tax benefits and other related liabilities for tax positions relating to the years that were under examination.
14. Earnings Per Share
The calculations of earnings per share are as follows:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ and shares in millions except per share amounts) | ($ and shares in millions except per share amounts) | 2021 | | 2020 | | 2021 | | 2020 | ($ and shares in millions except per share amounts) | 2022 | | 2021 | | 2022 | | 2021 |
Net Income from Continuing Operations Attributable to Merck & Co., Inc. | Net Income from Continuing Operations Attributable to Merck & Co., Inc. | $ | 4,567 | | | $ | 2,324 | | | $ | 8,525 | | | $ | 7,136 | | Net Income from Continuing Operations Attributable to Merck & Co., Inc. | $ | 3,248 | | | $ | 4,567 | | | $ | 11,502 | | | $ | 8,525 | |
Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests | Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests | — | | | 617 | | | 766 | | | 2,025 | | Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests | — | | | — | | | — | | | 766 | |
Net Income Attributable to Merck & Co., Inc. | Net Income Attributable to Merck & Co., Inc. | $ | 4,567 | | | $ | 2,941 | | | $ | 9,291 | | | $ | 9,161 | | Net Income Attributable to Merck & Co., Inc. | $ | 3,248 | | | $ | 4,567 | | | $ | 11,502 | | | $ | 9,291 | |
Average common shares outstanding | Average common shares outstanding | 2,530 | | | 2,529 | | | 2,531 | | | 2,530 | | Average common shares outstanding | 2,533 | | | 2,530 | | | 2,531 | | | 2,531 | |
Common shares issuable (1) | Common shares issuable (1) | 6 | | | 9 | | | 8 | | | 11 | | Common shares issuable (1) | 9 | | | 6 | | | 9 | | | 8 | |
Average common shares outstanding assuming dilution | Average common shares outstanding assuming dilution | 2,536 | | | 2,538 | | | 2,539 | | | 2,541 | | Average common shares outstanding assuming dilution | 2,542 | | | 2,536 | | | 2,540 | | | 2,539 | |
Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders: | Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders: | | Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders: | |
Income from Continuing Operations | Income from Continuing Operations | $ | 1.81 | | | $ | 0.92 | | | $ | 3.37 | | | $ | 2.82 | | Income from Continuing Operations | $ | 1.28 | | | $ | 1.81 | | | $ | 4.55 | | | $ | 3.37 | |
Income from Discontinued Operations | Income from Discontinued Operations | — | | | 0.24 | | | 0.30 | | | 0.80 | | Income from Discontinued Operations | — | | | — | | | — | | | 0.30 | |
Net Income | Net Income | $ | 1.81 | | | $ | 1.16 | | | $ | 3.67 | | | $ | 3.62 | | Net Income | $ | 1.28 | | | $ | 1.81 | | | $ | 4.55 | | | $ | 3.67 | |
Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders: | Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders: | | Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders: | |
Income from Continuing Operations | Income from Continuing Operations | $ | 1.80 | | | $ | 0.92 | | | $ | 3.36 | | | $ | 2.81 | | Income from Continuing Operations | $ | 1.28 | | | $ | 1.80 | | | $ | 4.53 | | | $ | 3.36 | |
Income from Discontinued Operations | Income from Discontinued Operations | — | | | 0.24 | | | 0.30 | | | 0.80 | | Income from Discontinued Operations | — | | | — | | | — | | | 0.30 | |
Net Income | Net Income | $ | 1.80 | | | $ | 1.16 | | | $ | 3.66 | | | $ | 3.61 | | Net Income | $ | 1.28 | | | $ | 1.80 | | | $ | 4.53 | | | $ | 3.66 | |
(1)Issuable primarily under share-based compensation plans.
For the third quarter of 2022 and 2021, and 2020, 82 million and 58 million, respectively, and for the first nine months of 2022 and 2021, and 2020, 105 million and 510 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.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
15. Other Comprehensive Income (Loss)
Changes in each component of other comprehensive income (loss) are as follows:
| | | Three Months Ended September 30, | | Three Months Ended September 30, |
($ in millions) | ($ in millions) | Derivatives | | Investments | | Employee Benefit Plans | | Foreign Currency Translation Adjustment | | Accumulated Other Comprehensive Income (Loss) | ($ in millions) | Derivatives | | Employee Benefit Plans | | Foreign Currency Translation Adjustment | | Accumulated Other Comprehensive Loss |
Balance July 1, 2020, net of taxes | $ | 15 | | | $ | — | | | $ | (4,162) | | | $ | (2,246) | | | $ | (6,393) | | |
Other comprehensive income (loss) before reclassification adjustments, pretax | (195) | | | — | | | 2 | | | 50 | | | (143) | | |
Tax | 41 | | | — | | | 1 | | | 35 | | | 77 | | |
Other comprehensive income (loss) before reclassification adjustments, net of taxes | (154) | | | — | | | 3 | | | 85 | | | (66) | | |
Reclassification adjustments, pretax | 22 | | (1) | — | | | 72 | | (3) | — | | | 94 | | |
Tax | (5) | | | — | | | (13) | | | — | | | (18) | | |
Reclassification adjustments, net of taxes | 17 | |
| — | |
| 59 | |
| — | | | 76 | | |
Other comprehensive income (loss), net of taxes | (137) | | | — | | | 62 | | | 85 | | | 10 | | |
Balance September 30, 2020, net of taxes | $ | (122) | | | $ | — | | | $ | (4,100) | | | $ | (2,161) | | | $ | (6,383) | | |
Balance July 1, 2021, net of taxes | Balance July 1, 2021, net of taxes | $ | (26) | | | $ | — | | | $ | (3,028) | | | $ | (1,574) | | | $ | (4,628) | | Balance July 1, 2021, net of taxes | $ | (26) | | | $ | (3,028) | | | $ | (1,574) | | | $ | (4,628) | |
Other comprehensive income (loss) before reclassification adjustments, pretax | Other comprehensive income (loss) before reclassification adjustments, pretax | 72 | | | — | | | (24) | | | (96) | | | (48) | | Other comprehensive income (loss) before reclassification adjustments, pretax | 72 | | | (24) | | | (96) | | | (48) | |
Tax | Tax | (16) | | | — | | | 16 | | | 12 | | | 12 | | Tax | (16) | | | 16 | | | 12 | | | 12 | |
Other comprehensive income (loss) before reclassification adjustments, net of taxes | Other comprehensive income (loss) before reclassification adjustments, net of taxes | 56 | | | — | | | (8) | | | (84) | | | (36) | | Other comprehensive income (loss) before reclassification adjustments, net of taxes | 56 | | | (8) | | | (84) | | | (36) | |
Reclassification adjustments, pretax | Reclassification adjustments, pretax | 36 | | (1) | — | | | 68 | | (3) | — | | | 104 | | Reclassification adjustments, pretax | 36 | | (1) | 68 | | (2) | — | | | 104 | |
Tax | Tax | (8) | | | — | | | (22) | | | — | | | (30) | | Tax | (8) | | | (22) | | | — | | | (30) | |
Reclassification adjustments, net of taxes | Reclassification adjustments, net of taxes | 28 | |
| — | |
| 46 | |
| — | | | 74 | | Reclassification adjustments, net of taxes | 28 | |
| 46 | |
| — | | | 74 | |
Other comprehensive income (loss), net of taxes | Other comprehensive income (loss), net of taxes | 84 | | | — | | | 38 | | | (84) | | | 38 | | Other comprehensive income (loss), net of taxes | 84 | | | 38 | | | (84) | | | 38 | |
Balance September 30, 2021, net of taxes | Balance September 30, 2021, net of taxes | $ | 58 | | | $ | — | | | $ | (2,990) | | | $ | (1,658) | | | $ | (4,590) | | Balance September 30, 2021, net of taxes | $ | 58 | | | $ | (2,990) | | | $ | (1,658) | | | $ | (4,590) | |
Balance July 1, 2022, net of taxes | | Balance July 1, 2022, net of taxes | $ | 390 | | | $ | (2,465) | | | $ | (2,252) | | | $ | (4,327) | |
Other comprehensive income (loss) before reclassification adjustments, pretax | | Other comprehensive income (loss) before reclassification adjustments, pretax | 682 | | | (294) | | | (618) | | | (230) | |
Tax | | Tax | (143) | | | 62 | | | 50 | | | (31) | |
Other comprehensive income (loss) before reclassification adjustments, net of taxes | | Other comprehensive income (loss) before reclassification adjustments, net of taxes | 539 | | | (232) | | | (568) | | | (261) | |
Reclassification adjustments, pretax | | Reclassification adjustments, pretax | (254) | | (1) | 77 | | (2) | — | | | (177) | |
Tax | | Tax | 53 | | | (31) | | | — | | | 22 | |
Reclassification adjustments, net of taxes | | Reclassification adjustments, net of taxes | (201) | |
| 46 | |
| — | | | (155) | |
Other comprehensive income (loss), net of taxes | | Other comprehensive income (loss), net of taxes | 338 | | | (186) | | | (568) | | | (416) | |
Balance September 30, 2022, net of taxes | | Balance September 30, 2022, net of taxes | $ | 728 | | | $ | (2,651) | | | $ | (2,820) | | | $ | (4,743) | |
| | | Nine Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | Derivatives | | Investments | | Employee Benefit Plans | | Foreign Currency Translation Adjustment | | Accumulated Other Comprehensive Income (Loss) | ($ in millions) | Derivatives | | Employee Benefit Plans | | Foreign Currency Translation Adjustment | | Accumulated Other Comprehensive Loss |
Balance January 1, 2020, net of taxes | $ | 31 | | | $ | 18 | | | $ | (4,261) | | | $ | (1,981) | | | $ | (6,193) | | |
Other comprehensive income (loss) before reclassification adjustments, pretax | (126) | | | 3 | | | (19) | | | (220) | | | (362) | | |
Tax | 27 | | | — | | | 12 | | | 40 | | | 79 | | |
Other comprehensive income (loss) before reclassification adjustments, net of taxes | (99) | | | 3 | | | (7) | | | (180) | | | (283) | | |
Reclassification adjustments, pretax | (68) | | (1) | (21) | | (2) | 210 | | (3) | — | | | 121 | | |
Tax | 14 | | | — | | | (42) | | | — | | | (28) | | |
Reclassification adjustments, net of taxes | (54) | | | (21) | | | 168 | | | — | | | 93 | | |
Other comprehensive income (loss), net of taxes | (153) | | | (18) | | | 161 | | | (180) | | | (190) | | |
Balance September 30, 2020, net of taxes | $ | (122) | | | $ | — | | | $ | (4,100) | | | $ | (2,161) | | | $ | (6,383) | | |
Balance January 1, 2021, net of taxes | Balance January 1, 2021, net of taxes | $ | (266) | | | $ | — | | | $ | (4,540) | | | $ | (1,828) | | | $ | (6,634) | | Balance January 1, 2021, net of taxes | $ | (266) | | | $ | (4,540) | | | $ | (1,828) | | | $ | (6,634) | |
Other comprehensive income (loss) before reclassification adjustments, pretax | Other comprehensive income (loss) before reclassification adjustments, pretax | 193 | | | — | | | 1,739 | | | (167) | | | 1,765 | | Other comprehensive income (loss) before reclassification adjustments, pretax | 193 | | | 1,739 | | | (167) | | | 1,765 | |
Tax | Tax | (41) | | | — | | | (385) | | | (84) | | | (510) | | Tax | (41) | | | (385) | | | (84) | | | (510) | |
Other comprehensive income (loss) before reclassification adjustments, net of taxes | Other comprehensive income (loss) before reclassification adjustments, net of taxes | 152 | | | — | | | 1,354 | | | (251) | | | 1,255 | | Other comprehensive income (loss) before reclassification adjustments, net of taxes | 152 | | | 1,354 | | | (251) | | | 1,255 | |
Reclassification adjustments, pretax | Reclassification adjustments, pretax | 218 | | (1) | — | | | 210 | | (3) | — | | | 428 | | Reclassification adjustments, pretax | 218 | | (1) | 210 | | (2) | — | | | 428 | |
Tax | Tax | (46) | | | — | | | (42) | | | — | | | (88) | | Tax | (46) | | | (42) | | | — | | | (88) | |
Reclassification adjustments, net of taxes | Reclassification adjustments, net of taxes | 172 | | | — | | | 168 | | | — | | | 340 | | Reclassification adjustments, net of taxes | 172 | | | 168 | | | — | | | 340 | |
Other comprehensive income (loss), net of taxes | Other comprehensive income (loss), net of taxes | 324 | | | — | | | 1,522 | | | (251) | | | 1,595 | | Other comprehensive income (loss), net of taxes | 324 | | | 1,522 | | | (251) | | | 1,595 | |
Spin-off of Organon (see Note 2) | Spin-off of Organon (see Note 2) | — | | | — | | | 28 | | | 421 | | | 449 | | Spin-off of Organon (see Note 2) | — | | | 28 | | | 421 | | | 449 | |
Balance September 30, 2021, net of taxes | Balance September 30, 2021, net of taxes | $ | 58 | | | $ | — | | | $ | (2,990) | | | $ | (1,658) | | | $ | (4,590) | | Balance September 30, 2021, net of taxes | $ | 58 | | | $ | (2,990) | | | $ | (1,658) | | | $ | (4,590) | |
Balance January 1, 2022, net of taxes | | Balance January 1, 2022, net of taxes | $ | 144 | | | $ | (2,743) | | | $ | (1,830) | | | $ | (4,429) | |
Other comprehensive income (loss) before reclassification adjustments, pretax | | Other comprehensive income (loss) before reclassification adjustments, pretax | 1,233 | | | (125) | | | (1,001) | | | 107 | |
Tax | | Tax | (259) | | | 25 | | | 11 | | | (223) | |
Other comprehensive income (loss) before reclassification adjustments, net of taxes | | Other comprehensive income (loss) before reclassification adjustments, net of taxes | 974 | | | (100) | | | (990) | | | (116) | |
Reclassification adjustments, pretax | | Reclassification adjustments, pretax | (493) | | (1) | 266 | | (2) | — | | | (227) | |
Tax | | Tax | 103 | | | (74) | | | — | | | 29 | |
Reclassification adjustments, net of taxes | | Reclassification adjustments, net of taxes | (390) | | | 192 | | | — | | | (198) | |
Other comprehensive income (loss), net of taxes | | Other comprehensive income (loss), net of taxes | 584 | | | 92 | | | (990) | | | (314) | |
Balance September 30, 2022, net of taxes | | Balance September 30, 2022, net of taxes | $ | 728 | | | $ | (2,651) | | | $ | (2,820) | | | $ | (4,743) | |
(1) Primarily relates to foreign currency cash flow hedges that were reclassified from AOCL to Sales.
(2) Represents net realized gains on the sales of available-for-sale debt securities that were reclassified from AOCL to Other (income) expense, net.
(3) Includes net amortization of prior service cost and actuarial gains and losses included in net periodic benefit cost (see Note 11).
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
16. Segment Reporting
The Company’s operations are principally managed on a productsproduct basis and include 2two operating segments, which are the Pharmaceutical and Animal Health segments, both of which are reportable segments.
The Pharmaceutical segment includes human health pharmaceutical and vaccine products. 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. Human health vaccine products consist of preventive pediatric, adolescent and adult vaccines, primarily administered at physician offices.vaccines. The Company sells these human health vaccines primarily to physicians, wholesalers, physician distributors and government entities. A large component of pediatric and adolescent vaccine sales are made 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 Animal Health segment discovers, develops, manufactures and markets a wide range of veterinary pharmaceutical and vaccine products, as well as health management solutions and services, for the prevention, treatment and control of disease in all major livestock and companion animal species. The Company also offers an extensive suite of digitally connected identification, traceability and monitoring products. The Company sells its products to veterinarians, distributors and animal producers.
The Company previously had a Healthcare Services segment that provided services and solutions focused on engagement, health analytics and clinical services to improve the value of care delivered to patients. The Company divested the remaining businesses in this segment during the first quarter of 2020.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Sales of the Company’s products were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2021 | | 2020 | | 2021 | | 2020 |
($ in millions) | U.S. | | Int’l | | Total | | U.S. | | Int’l | | Total | | U.S. | | Int’l | | Total | | U.S. | | Int’l | | Total |
Pharmaceutical: | | | | | | | | | | | | | | | | | | | | | | | |
Oncology | | | | | | | | | | | | | | | | | | | | | | | |
Keytruda | $ | 2,580 | | | $ | 1,954 | | | $ | 4,534 | | | $ | 2,157 | | | $ | 1,559 | | | $ | 3,715 | | | $ | 7,108 | | | $ | 5,501 | | | $ | 12,609 | | | $ | 6,106 | | | $ | 4,281 | | | $ | 10,387 | |
Alliance revenue - Lynparza (1) | 129 | | | 117 | | | 246 | | | 107 | | | 89 | | | 196 | | | 371 | | | 350 | | | 721 | | | 297 | | | 223 | | | 519 | |
Alliance revenue - Lenvima (1) | 114 | | | 74 | | | 188 | | | 82 | | | 60 | | | 142 | | | 287 | | | 211 | | | 498 | | | 270 | | | 152 | | | 421 | |
Vaccines | | | | | | | | | | | | | | | | | | | | | | | |
Gardasil/Gardasil 9 | 839 | | | 1,154 | | | 1,993 | | | 579 | | | 608 | | | 1,187 | | | 1,605 | | | 2,539 | | | 4,144 | | | 1,209 | | | 1,732 | | | 2,941 | |
ProQuad/M-M-R II/Varivax | 537 | | | 125 | | | 661 | | | 437 | | | 139 | | | 576 | | | 1,255 | | | 371 | | | 1,626 | | | 1,033 | | | 356 | | | 1,390 | |
Pneumovax 23 | 181 | | | 97 | | | 277 | | | 276 | | | 99 | | | 375 | | | 354 | | | 247 | | | 600 | | | 478 | | | 270 | | | 748 | |
RotaTeq | 135 | | | 92 | | | 227 | | | 114 | | | 96 | | | 210 | | | 364 | | | 229 | | | 593 | | | 355 | | | 246 | | | 601 | |
Vaqta | 32 | | | 16 | | | 48 | | | 32 | | | 19 | | | 51 | | | 80 | | | 58 | | | 138 | | | 79 | | | 60 | | | 139 | |
Hospital Acute Care | | | | | | | | | | | | | | | | | | | | | | | |
Bridion | 181 | | | 188 | | | 369 | | | 162 | | | 157 | | | 320 | | | 545 | | | 551 | | | 1,096 | | | 412 | | | 431 | | | 843 | |
Prevymis | 39 | | | 57 | | | 96 | | | 32 | | | 46 | | | 77 | | | 111 | | | 159 | | | 270 | | | 87 | | | 113 | | | 200 | |
Noxafil | 19 | | | 45 | | | 64 | | | 13 | | | 66 | | | 79 | | | 48 | | | 149 | | | 197 | | | 27 | | | 220 | | | 247 | |
Primaxin | — | | | 69 | | | 70 | | | 1 | | | 73 | | | 74 | | | — | | | 194 | | | 194 | | | 2 | | | 187 | | | 189 | |
Cancidas | 1 | | | 56 | | | 56 | | | 1 | | | 49 | | | 50 | | | 4 | | | 164 | | | 168 | | | 2 | | | 147 | | | 148 | |
Invanz | (2) | | | 55 | | | 53 | | | 1 | | | 50 | | | 51 | | | (2) | | | 159 | | | 157 | | | 7 | | | 152 | | | 159 | |
Zerbaxa | (1) | | | (1) | | | (2) | | | 20 | | | 23 | | | 43 | | | (5) | | | (6) | | | (11) | | | 57 | | | 54 | | | 112 | |
Immunology | | | | | | | | | | | | | | | | | | | | | | | |
Simponi | — | | | 203 | | | 203 | | | — | | | 209 | | | 209 | | | — | | | 619 | | | 619 | | | — | | | 615 | | | 615 | |
Remicade | — | | | 73 | | | 73 | | | — | | | 82 | | | 82 | | | — | | | 233 | | | 233 | | | — | | | 242 | | | 242 | |
Neuroscience | | | | | | | | | | | | | | | | | | | | | | | |
Belsomra | 23 | | | 58 | | | 81 | | | 18 | | | 63 | | | 81 | | | 56 | | | 183 | | | 238 | | | 67 | | | 177 | | | 244 | |
Virology | | | | | | | | | | | | | | | | | | | | | | | |
Isentress/Isentress HD | 77 | | | 112 | | | 189 | | | 92 | | | 113 | | | 205 | | | 222 | | | 368 | | | 590 | | | 243 | | | 403 | | | 646 | |
Cardiovascular | | | | | | | | | | | | | | | | | | | | | | | |
Alliance revenue-Adempas/Verquvo (2) | 73 | | | 27 | | | 100 | | | 78 | | | 5 | | | 83 | | | 222 | | | 26 | | | 248 | | | 200 | | | 16 | | | 216 | |
Adempas | — | | | 59 | | | 59 | | | — | | | 55 | | | 55 | | | — | | | 188 | | | 188 | | | — | | | 167 | | | 167 | |
Diabetes | | | | | | | | | | | | | | | | | | | | | | | |
Januvia | 365 | | | 487 | | | 852 | | | 342 | | | 479 | | | 821 | | | 997 | | | 1,448 | | | 2,445 | | | 1,110 | | | 1,339 | | | 2,449 | |
Janumet | 86 | | | 401 | | | 487 | | | 105 | | | 400 | | | 506 | | | 244 | | | 1,205 | | | 1,449 | | | 361 | | | 1,138 | | | 1,499 | |
Other pharmaceutical (3) | 262 | | | 308 | | | 572 | | | 193 | | | 333 | | | 526 | | | 745 | | | 957 | | | 1,704 | | | 706 | | | 969 | | | 1,675 | |
Total Pharmaceutical segment sales | 5,670 | | | 5,826 | | | 11,496 | | | 4,842 | | | 4,872 | | | 9,714 | | | 14,611 | | | 16,103 | | | 30,714 | | | 13,108 | | | 13,690 | | | 26,797 | |
Animal Health: | | | | | | | | | | | | | | | | | | | | | | | |
Livestock | 190 | | | 675 | | | 864 | | | 165 | | | 593 | | | 758 | | | 508 | | | 1,996 | | | 2,503 | | | 448 | | | 1,697 | | | 2,145 | |
Companion Animals | 277 | | | 276 | | | 553 | | | 234 | | | 228 | | | 462 | | | 855 | | | 948 | | | 1,804 | | | 676 | | | 714 | | | 1,390 | |
Total Animal Health segment sales | 467 | | | 951 | | | 1,417 | | | 399 | | | 821 | | | 1,220 | | | 1,363 | | | 2,944 | | | 4,307 | | | 1,124 | | | 2,411 | | | 3,535 | |
Other segment sales (4) | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 23 | | | — | | | 23 | |
Total segment sales | 6,137 | | | 6,777 | | | 12,913 | | | 5,241 | | | 5,693 | | | 10,934 | | | 15,974 | | | 19,047 | | | 35,021 | | | 14,255 | | | 16,101 | | | 30,355 | |
Other (5) | 139 | | | 101 | | | 241 | | | 9 | | | (14) | | | (5) | | | 192 | | | (30) | | | 162 | | | 46 | | | 168 | | | 215 | |
| $ | 6,276 | | | $ | 6,878 | | | $ | 13,154 | | | $ | 5,250 | | | $ | 5,679 | | | $ | 10,929 | | | $ | 16,166 | | | $ | 19,017 | | | $ | 35,183 | | | $ | 14,301 | | | $ | 16,269 | | | $ | 30,570 | |
U.S. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
($ in millions) | U.S. | | Int’l | | Total | | U.S. | | Int’l | | Total | | U.S. | | Int’l | | Total | | U.S. | | Int’l | | Total |
Pharmaceutical: | | | | | | | | | | | | | | | | | | | | | | | |
Oncology | | | | | | | | | | | | | | | | | | | | | | | |
Keytruda | $ | 3,331 | | | $ | 2,095 | | | $ | 5,426 | | | $ | 2,580 | | | $ | 1,954 | | | $ | 4,534 | | | $ | 9,307 | | | $ | 6,180 | | | $ | 15,487 | | | $ | 7,108 | | | $ | 5,501 | | | $ | 12,609 | |
Alliance revenue-Lynparza (1) | 144 | | | 140 | | | 284 | | | 129 | | | 117 | | | 246 | | | 427 | | | 397 | | | 825 | | | 371 | | | 350 | | | 721 | |
Alliance revenue-Lenvima (1) | 142 | | | 60 | | | 202 | | | 114 | | | 74 | | | 188 | | | 426 | | | 235 | | | 660 | | | 287 | | | 211 | | | 498 | |
Alliance revenue-Reblozyl (2) | 32 | | | 7 | | | 39 | | | — | | | — | | | — | | | 87 | | | 37 | | | 124 | | | — | | | — | | | — | |
Vaccines | | | | | | | | | | | | | | | | | | | | | | | |
Gardasil/Gardasil 9 | 957 | | | 1,337 | | | 2,294 | | | 839 | | | 1,154 | | | 1,993 | | | 1,803 | | | 3,624 | | | 5,428 | | | 1,605 | | | 2,539 | | | 4,144 | |
ProQuad/M-M-R II/Varivax | 532 | | | 136 | | | 668 | | | 537 | | | 125 | | | 661 | | | 1,337 | | | 379 | | | 1,716 | | | 1,255 | | | 371 | | | 1,626 | |
RotaTeq | 154 | | | 102 | | | 256 | | | 135 | | | 92 | | | 227 | | | 427 | | | 218 | | | 644 | | | 364 | | | 229 | | | 593 | |
Pneumovax 23 | 68 | | | 63 | | | 131 | | | 181 | | | 97 | | | 277 | | | 280 | | | 177 | | | 457 | | | 354 | | | 247 | | | 600 | |
Vaqta | 27 | | | 36 | | | 64 | | | 32 | | | 16 | | | 48 | | | 72 | | | 62 | | | 134 | | | 80 | | | 58 | | | 138 | |
Hospital Acute Care | | | | | | | | | | | | | | | | | | | | | | | |
Bridion | 233 | | | 190 | | | 423 | | | 181 | | | 188 | | | 369 | | | 665 | | | 579 | | | 1,244 | | | 545 | | | 551 | | | 1,096 | |
Prevymis | 49 | | | 64 | | | 114 | | | 39 | | | 57 | | | 96 | | | 136 | | | 174 | | | 310 | | | 111 | | | 159 | | | 270 | |
Dificid | 72 | | | 6 | | | 77 | | | 52 | | | 2 | | | 54 | | | 184 | | | 12 | | | 196 | | | 108 | | | 7 | | | 115 | |
Primaxin | — | | | 63 | | | 63 | | | — | | | 69 | | | 70 | | | 1 | | | 185 | | | 185 | | | — | | | 194 | | | 194 | |
Noxafil | 13 | | | 49 | | | 62 | | | 19 | | | 45 | | | 64 | | | 39 | | | 141 | | | 180 | | | 48 | | | 149 | | | 197 | |
Invanz | 2 | | | 48 | | | 50 | | | (2) | | | 55 | | | 53 | | | 4 | | | 144 | | | 148 | | | (2) | | | 159 | | | 157 | |
Cancidas | 1 | | | 42 | | | 43 | | | 1 | | | 56 | | | 56 | | | 5 | | | 133 | | | 138 | | | 4 | | | 164 | | | 168 | |
Zerbaxa | 24 | | | 19 | | | 43 | | | (1) | | | (1) | | | (2) | | | 64 | | | 55 | | | 120 | | | (5) | | | (6) | | | (11) | |
Cardiovascular | | | | | | | | | | | | | | | | | | | | | | | |
Alliance revenue-Adempas/Verquvo (3) | 85 | | | 3 | | | 88 | | | 73 | | | 27 | | | 100 | | | 244 | | | 14 | | | 258 | | | 222 | | | 26 | | | 248 | |
Adempas | — | | | 57 | | | 57 | | | — | | | 59 | | | 59 | | | — | | | 181 | | | 181 | | | — | | | 188 | | | 188 | |
Virology | | | | | | | | | | | | | | | | | | | | | | | |
Lagevrio | — | | | 436 | | | 436 | | | — | | | — | | | — | | | 1,523 | | | 3,336 | | | 4,859 | | | — | | | — | | | — | |
Isentress/Isentress HD | 68 | | | 93 | | | 161 | | | 77 | | | 112 | | | 189 | | | 196 | | | 270 | | | 466 | | | 222 | | | 368 | | | 590 | |
Neuroscience | | | | | | | | | | | | | | | | | | | | | | | |
Belsomra | 20 | | | 42 | | | 62 | | | 23 | | | 58 | | | 81 | | | 60 | | | 139 | | | 199 | | | 56 | | | 183 | | | 238 | |
Immunology | | | | | | | | | | | | | | | | | | | | | | | |
Simponi | — | | | 173 | | | 173 | | | — | | | 203 | | | 203 | | | — | | | 540 | | | 540 | | | — | | | 619 | | | 619 | |
Remicade | — | | | 49 | | | 49 | | | — | | | 73 | | | 73 | | | — | | | 163 | | | 163 | | | — | | | 233 | | | 233 | |
Diabetes | | | | | | | | | | | | | | | | | | | | | | | |
Januvia | 332 | | | 385 | | | 717 | | | 365 | | | 487 | | | 852 | | | 958 | | | 1,294 | | | 2,252 | | | 997 | | | 1,448 | | | 2,445 | |
Janumet | 90 | | | 327 | | | 417 | | | 86 | | | 401 | | | 487 | | | 258 | | | 1,089 | | | 1,347 | | | 244 | | | 1,205 | | | 1,449 | |
Other pharmaceutical (4) | 244 | | | 321 | | | 564 | | | 210 | | | 306 | | | 518 | | | 616 | | | 949 | | | 1,565 | | | 637 | | | 950 | | | 1,589 | |
Total Pharmaceutical segment sales | 6,620 | | | 6,343 | | | 12,963 | | | 5,670 | | | 5,826 | | | 11,496 | | | 19,119 | | | 20,707 | | | 39,826 | | | 14,611 | | | 16,103 | | | 30,714 | |
Animal Health: | | | | | | | | | | | | | | | | | | | | | | | |
Livestock | 186 | | | 643 | | | 829 | | | 190 | | | 675 | | | 864 | | | 521 | | | 1,965 | | | 2,486 | | | 508 | | | 1,996 | | | 2,503 | |
Companion Animals | 289 | | | 253 | | | 542 | | | 277 | | | 276 | | | 553 | | | 904 | | | 929 | | | 1,834 | | | 855 | | | 948 | | | 1,804 | |
Total Animal Health segment sales | 475 | | | 896 | | | 1,371 | | | 467 | | | 951 | | | 1,417 | | | 1,425 | | | 2,894 | | | 4,320 | | | 1,363 | | | 2,944 | | | 4,307 | |
Total segment sales | 7,095 | | | 7,239 | | | 14,334 | | | 6,137 | | | 6,777 | | | 12,913 | | | 20,544 | | | 23,601 | | | 44,146 | | | 15,974 | | | 19,047 | | | 35,021 | |
Other (5) | 227 | | | 398 | | | 625 | | | 139 | | | 101 | | | 241 | | | 383 | | | 925 | | | 1,307 | | | 192 | | | (30) | | | 162 | |
| $ | 7,322 | | | $ | 7,637 | | | $ | 14,959 | | | $ | 6,276 | | | $ | 6,878 | | | $ | 13,154 | | | $ | 20,927 | | | $ | 24,526 | | | $ | 45,453 | | | $ | 16,166 | | | $ | 19,017 | | | $ | 35,183 | |
U.S. plus international may not equal total due to rounding.(1) Alliance revenue for Lynparza and Lenvima represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs (see Note 4).
(2) Alliance revenue for Reblozyl represents royalties and, for the year-to-date period, a payment received related to the achievement of a regulatory milestone (see Note 4).
(3) Alliance revenue for Adempas/Verquvo represents Merck’s share of profits from sales in Bayer’s marketing territories, which are product sales net of cost of sales and commercialization costs (see Note 4).
(3)(4) Other pharmaceutical primarily reflects sales of other human health pharmaceutical products, including products within the franchises not listed separately.
(4) Represents sales for the Healthcare Services segment. All the businesses in the Healthcare Services segment were fully divested in the first quarter of 2020.
(5) Other is primarily comprised of miscellaneous corporate revenues,revenue, including revenue hedging activities, as well as revenue from third-party manufacturing sales.arrangements (including sales to Organon). Other for the three and nine months ended September 30, 2022 and 2021 also includes $135$156 million and $185$191 million, respectively, related to the achievement of milestonesupfront and milestone payments received by Merck for an out-licensed product that triggered contingent payments to Merck.out-licensing arrangements.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Product sales are recorded net of the provision for discounts, including chargebacks, which are customer discounts that occur when a contracted customer purchases through an intermediary wholesale purchaser, and rebates that are 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 U.S. sales by $3.1$3.3 billion and $2.9$3.1 billion for the three months ended September 30, 20212022 and 2020,2021, respectively, and $9.1 billion and $8.3 billion for both the nine months ended September 30, 20212022 and 2020, respectively.2021.
Consolidated sales by geographic area where derived are as follows:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 |
United States | United States | $ | 6,276 | | | $ | 5,250 | | | $ | 16,166 | | | $ | 14,301 | | United States | $ | 7,322 | | | $ | 6,276 | | | $ | 20,927 | | | $ | 16,166 | |
Europe, Middle East and Africa | Europe, Middle East and Africa | 3,342 | | | 2,946 | | | 9,912 | | | 8,537 | | Europe, Middle East and Africa | 3,286 | | | 3,342 | | | 11,228 | | | 9,912 | |
China | China | 1,307 | | | 791 | | | 3,004 | | | 2,060 | | China | 1,442 | | | 1,307 | | | 3,957 | | | 3,004 | |
Japan | Japan | 638 | | | 671 | | | 1,929 | | | 1,875 | | Japan | 673 | | | 638 | | | 2,776 | | | 1,929 | |
Asia Pacific (other than China and Japan) | Asia Pacific (other than China and Japan) | 613 | | | 545 | | | 1,782 | | | 1,560 | | Asia Pacific (other than China and Japan) | 854 | | | 613 | | | 2,792 | | | 1,782 | |
Latin America | Latin America | 599 | | | 499 | | | 1,631 | | | 1,374 | | Latin America | 684 | | | 599 | | | 1,933 | | | 1,631 | |
Other | Other | 379 | | | 227 | | | 759 | | | 863 | | Other | 698 | | | 379 | | | 1,840 | | | 759 | |
| | $ | 13,154 | | | $ | 10,929 | | | $ | 35,183 | | | $ | 30,570 | | | $ | 14,959 | | | $ | 13,154 | | | $ | 45,453 | | | $ | 35,183 | |
A reconciliation of segment profits to Income from Continuing Operations Before Taxes is as follows:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 |
Segment profits: | Segment profits: | | Segment profits: | |
Pharmaceutical segment | Pharmaceutical segment | $ | 8,606 | | | $ | 7,026 | | | $ | 22,450 | | | $ | 19,235 | | Pharmaceutical segment | $ | 9,590 | | | $ | 8,606 | | | $ | 28,263 | | | $ | 22,450 | |
Animal Health segment | Animal Health segment | 505 | | | 459 | | | 1,629 | | | 1,347 | | Animal Health segment | 515 | | | 505 | | | 1,672 | | | 1,629 | |
Other segment | — | | | (1) | | | — | | | 1 | | |
Total segment profits | Total segment profits | 9,111 | | | 7,484 | | | 24,079 | | | 20,583 | | Total segment profits | 10,105 | | | 9,111 | | | 29,935 | | | 24,079 | |
Other profits | Other profits | 141 | | | (28) | | | 29 | | | 135 | | Other profits | 377 | | | 141 | | | 831 | | | 29 | |
Unallocated: | Unallocated: | | Unallocated: | |
Interest income | Interest income | 7 | | | 9 | | | 27 | | | 48 | | Interest income | 40 | | | 7 | | | 62 | | | 27 | |
Interest expense | Interest expense | (196) | | | (203) | | | (597) | | | (624) | | Interest expense | (244) | | | (196) | | | (727) | | | (597) | |
Amortization | Amortization | (360) | | | (406) | | | (1,231) | | | (1,393) | | Amortization | (460) | | | (360) | | | (1,623) | | | (1,231) | |
Depreciation | Depreciation | (358) | | | (367) | | | (1,031) | | | (1,105) | | Depreciation | (448) | | | (358) | | | (1,257) | | | (1,031) | |
Research and development | Research and development | (2,312) | | | (3,231) | | | (8,775) | | | (7,251) | | Research and development | (4,277) | | | (2,312) | | | (9,374) | | | (8,775) | |
Restructuring costs | Restructuring costs | (107) | | | (113) | | | (487) | | | (265) | | Restructuring costs | (94) | | | (107) | | | (288) | | | (487) | |
Other unallocated, net | Other unallocated, net | (660) | | | (439) | | | (2,044) | | | (1,720) | | Other unallocated, net | (1,416) | | | (660) | | | (4,628) | | | (2,044) | |
| | $ | 5,266 | | | $ | 2,706 | | | $ | 9,970 | | | $ | 8,408 | | | $ | 3,583 | | | $ | 5,266 | | | $ | 12,931 | | | $ | 9,970 | |
Pharmaceutical segment profits are comprised of segment sales less standard costs, as well as selling, general and administrative expenses directly incurred by the segment. Animal Health segment profits are comprised of segment sales, less all cost of sales, as well as selling, general and administrative expenses and research and development costs directly incurred by the segment. For internal management reporting presented to the chief operating decision maker, Merck does not allocate the remaining cost of sales not included in segment profits as described above, research and development expenses incurred in Merck Research Laboratories, the Company’s research and development division that focuses on human health-related activities, 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. In addition, costs related to restructuring activities, as well as the amortization of intangible assets and purchase accounting adjustments are not allocated to segments.
Other profits are primarily comprised of miscellaneous corporate profits, as well as operating profits related to third-party manufacturing sales.arrangements.
Other unallocated, net, includes expenses from corporate and manufacturing cost centers, goodwill and other intangible asset impairment charges, gains or losses on sales of businesses, expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration, and other miscellaneous income or expense items.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Management
In October 2022, Merck announced that its board of directors unanimously elected Robert M. Davis, currently Chief Executive Officer and President, to serve as chairman of the board, effective December 1, 2022. He will succeed Kenneth C. Frazier, who will retire on November 30, 2022.
Business Developments
Below is a summary of significant business development activity thus far in 2022. See Note 3 to the condensed consolidated financial statements for additional information.
In September 2022, Merck exercised its option to jointly develop and commercialize personalized cancer vaccine mRNA-4157/V940 pursuant to the terms of an existing collaboration and license agreement with Moderna, Inc. (Moderna), which resulted in a $250 million charge in Research and development expenses in the third quarter and first nine months of 2022. The payment to Moderna was made in the fourth quarter of 2022. mRNA-4157/V940 is currently being evaluated in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma in a Phase 2 clinical trial being conducted by Moderna. Under the 2016 agreement, as amended in 2018, Merck and Moderna will collaborate on development and commercialization and will share costs and any profits equally under this worldwide collaboration.
In August 2022, Merck and Orna Therapeutics (Orna), a biotechnology company pioneering a new investigational class of engineered circular RNA (oRNA) therapies, entered into a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology. Under the terms of the agreement, Merck made an upfront payment to Orna of $150 million, which was recorded in Research and development expenses in the third quarter and first nine months of 2022. In addition, Orna is eligible to receive future contingent development-related payments, as well as regulatory and sales-based milestone payments contingent upon the progress of the multiple vaccine and therapeutic programs, as well as royalties on any approved products derived from the collaboration. Merck also invested $100 million in Orna’s Series B preferred shares in the fourth quarter of 2022.
In July 2022, Merck and Orion Corporation (Orion) announced a global co-development and co-commercialization agreement for Orion’s investigational candidate ODM-208 (MK-5684) and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production. ODM-208 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer. Merck made an upfront payment to Orion of $290 million, which was recorded in Research and development expenses in the third quarter and first nine months of 2022.
Also in July 2022, Merck and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) closed a license and collaboration agreement in which Merck gained exclusive worldwide rights for the development, manufacture and commercialization of an investigational antibody drug conjugate (ADC) (MK-1200) for the treatment of solid tumors. Under the terms of the agreement, Merck and Kelun-Biotech will collaborate on the early clinical development of the investigational ADC. Merck made an upfront payment of $35 million, which was recorded in Research and development expenses in the third quarter and first nine months of 2022. Kelun-Biotech is also eligible to receive future contingent developmental, regulatory and sales-based milestone payments, as well as tiered royalties on future net sales.
In May 2022, in connection with an existing arrangement, Merck exercised its option to obtain an exclusive license outside of China for the development, manufacture and commercialization of Kelun-Biotech’s trophoblast antigen 2 (TROP2)-targeting ADC programs, including its lead compound, SKB-264 (MK-2870). SKB-264 is currently being evaluated in Phase 2 trials for non-small-cell lung cancer (NSCLC) and advanced solid tumors. Under the terms of the agreement, Merck and Kelun-Biotech will collaborate on certain early clinical development plans, including evaluating the potential of SKB-264 as a monotherapy and in combination with Keytruda for advanced solid tumors. Upon option exercise, Merck made a payment of $30 million, which was recorded in Research and development expenses in the first nine months of 2022, and agreed to make additional payments upon completion of specified project activities, technology transfer, as well as payments to fund Kelun-Biotech’s ongoing research and development activities. In addition, Kelun-Biotech is eligible to receive future contingent developmental and sales-based milestone payments and royalties on future net sales.
Spin-Off of Organon & Co.
On June 2, 2021, Merck completed the spin-off of products from its women’s health, biosimilars and established brands businesses into a new, independent, publicly traded company named Organon & Co. (Organon) through a distribution of Organon’s publicly traded stock to Company shareholders. The distribution is expected to qualify and has been treated as tax-free to the Company and its shareholders for U.S. federal income tax purposes. The established brands included in the transaction consisted of dermatology, non-opioid pain management, respiratory, select cardiovascular products, as well as the rest of Merck’s diversified brands franchise. Merck’s existing research pipeline programs continue to be owned and developed
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
within Merck as planned. The historical results of the women’s health, biosimilars and established brands businesses that were contributed to Organon in the spin-off have been reflected as discontinued operations in the Company’s consolidated financial statements through the date of the spin-off (see Note 2 to the condensed consolidated financial statements).
Other Developments
Business Developments
Below is a summary of significant business development activity thus farWar in 2021. See Note 3 to the condensed consolidated financial statements for additional information.
In January 2021, Merck entered into an exclusive license and research collaboration agreement with Artiva Biotherapeutics, Inc. (Artiva) to discover, develop and manufacture CAR-NK cells that target certain solid tumors using Artiva’s proprietary platform. Merck and Artiva agreed to engage in up to three different research programs, each covering a collaboration target. Merck has sole responsibility for all development and commercialization activities (including regulatory filing and approval). Under the terms of the agreement, Merck made an upfront payment of $30 million, which was included in Research and development expenses in the first nine months of 2021, for license and other rights for the first two collaboration targets and agreed to make another upfront payment of $15 million for license and other rights for the third collaboration target when it is selected by Merck and accepted by Artiva. In addition, Artiva is eligible to receive future contingent milestone payments and tiered royalties on future sales.Ukraine
In March 2021, MerckFebruary 2022, Russia invaded Ukraine. The Company’s primary concerns are the safety and Gilead Sciences, Inc. (Gilead) entered into an agreement to jointly develop and commercialize long-acting treatments in HIV that combine Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, and Gilead’s investigational capsid inhibitor, lenacapavir. The collaboration will initially focus on long-acting oral formulations and long-acting injectable formulations of these combination products, with other formulations potentially added to the collaboration as mutually agreed. There was no upfront payment made by either party upon entering into the agreement.
In April 2021, Merck acquired Pandion Therapeutics, Inc. (Pandion), a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, for total consideration of $1.9 billion. Pandion is advancing a pipeline of precision immune modulators targeting critical immune control nodes.
In September 2021, Merck and Acceleron Pharma Inc. (Acceleron), a publicly traded biopharmaceutical company, entered into a definitive agreement under which Merck will acquire Acceleron for $180 per share in cash for an approximate total equity value of $11.5 billion. Acceleron is focused on harnessing the power of the transforming growth factor (TGF)-beta superfamily of proteins that is known to play a central role in the regulation of cell growth, differentiation and repair. Under the terms of the acquisition agreement, Merck, through a subsidiary, initiated a tender offer to acquire all outstanding shares of Acceleron. The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Acceleron’s outstanding shares, receipt of applicable regulatory approvals, and other customary conditions. The transaction is expected to close in the fourth quarter of 2021.
Coronavirus Disease 2019 (COVID-19) Update
Overall, in response to the COVID-19 pandemic, Merck is focused on protecting the safetywell-being of its employees and ensuring that its supply ofpatients and customers have continued access to medicines and vaccines reachesneeded for patient and public health. The Company is working cross-functionally across the globe to monitor and mitigate interruptions to business continuity resulting from the war, including its patients, contributing its scientific expertiseimpact on Merck’s supply chain, operations and clinical trials. For humanitarian reasons, the Company is continuing to the development of an antiviral therapy, supporting efforts to expand manufacturing capacity and supply of SARS-CoV-2/COVID-19essential medicines and vaccines (see below),in Russia while working to maintain compliance with evolving international sanctions. Merck is donating profits resulting from its operations in Russia to humanitarian causes. The Company does not have research or manufacturing facilities in Russia, currently does not plan to make further investments in Russia, and supporting health care providershas suspended screening and Merck’s communities. Although COVID-19-related disruptions negatively affected resultsenrollment in ongoing clinical trials as well as planning for new studies in Russia, although the Company continues to treat patients already enrolled in existing clinical trials and collect data from these studies. The Company is also using its resources to help alleviate the humanitarian crisis in Ukraine, including through donations of funds and products. The financial impacts of the war were immaterial to the Company’s consolidated financial statements for the third quarter and first nine months of 2021,2022. Combined sales to Russia and Ukraine were approximately 1% of total Merck consolidated sales for the full year of 2021.
The combination of Russia’s invasion of Ukraine, as well as the resultant economic sanctions imposed by the U.S., the European Union (EU) and other governments are having pervasive effects in markets worldwide. The Company is unable to determine at this time the future impacts of this war either directly or indirectly on the Company’s business.
COVID-19
Although COVID-19-related disruptions had some negative effects on sales for the third quarter and first nine months of 2022, Merck continues to experience strongbelieve that global underlying demand across its business.
health systems and patients have largely adapted to the impacts of the COVID-19 pandemic. Merck’s sales of Lagevrio (molnupiravir), an investigational oral antiviral COVID-19 medicine, were $436 million and $4.9 billion in the third quarter and first nine months of 2022, respectively. In the third quarter and first nine months of 2021, theCOVID-19-related disruptions resulted in an estimated negative impact of the COVID-19 pandemic to Merck’sPharmaceutical segment sales wasof approximately $350 million and $1.3 billion, respectively, allbecause a substantial portion of which related to the Pharmaceutical segment. In the third quarter and first nine months of 2020, the estimated negative impact of the COVID-19 pandemic to Merck’s Pharmaceutical sales was approximately $400 million and $1.7 billion, respectively. Roughly 75% of Merck’s
Pharmaceutical segment revenue is comprised of physician-administered products, which despite strong underlying demand, have beenwere unfavorably affected by social distancing measures and fewer well visits.
In April 2021, Merck announced it was discontinuing the development of MK-7110 (formerly known as CD24Fc) for the treatment of hospitalized patients with COVID-19, which was obtained as part of Merck’s acquisition of OncoImmune (see Note 3 to the condensed consolidated financial statements). This decision resulted in charges of $207 million to Cost of sales in the first nine months of 2021.
Operating expenses reflect a minor positive effect in the third quarter and first nine months of 2021 as investments in COVID-19-related research programs largely offset the favorable impact of lower spending in other areas due to the COVID-19 pandemic. Operating expenses were positively affected in the third quarter and first nine months of 2020 by approximately $100 million and $500 million, respectively, primarily driven by lower promotional and selling costs, as well as lower research and development expenses due to the COVID-19 pandemic.
Merck continues to believe that global health systems and patients have largely adapted to the impacts of the COVID-19 pandemic, and that while certain negative impacts will persist, the trend will continue to improve. For the full year of 2021, Merck assumes a net unfavorable impact to sales of less than 3% due to the COVID-19 pandemic, all of which relates to the Pharmaceutical segment.
In November 2021, the Medicines and Healthcare products Regulatory Agency in the United Kingdom (U.K.) granted authorization for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The authorization is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir in non-hospitalized, unvaccinated adult patients with laboratory-confirmed mild-to-moderate COVID-19, symptom onset within five days of study randomization and at least one risk factor associated with poor disease outcomes. In the U.K., Lagevrio is the planned trademark for molnupiravir. In October 2021, Merck submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. The FDA subsequently announced a November 30, 2021 meeting of its Antimicrobial Drugs Advisory Committee to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate COVID-19 in adults who have tested positive for COVID-19 and who are at high risk of progression to severe COVID-19, including hospitalization or death. Also in October 2021, the European Medicines Agency (EMA) initiated a rolling review for molnupiravir. Merck plans to work with the Committee for Medicinal Products for Human Use (CHMP) of the EMA to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics LP (Ridgeback Bio). The companies are actively working with other regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months. In anticipation of the results from the MOVe-OUT trial and the potential for regulatory authorization or approval, Merck has been producing molnupiravir at risk. Merck expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million additional courses expected to be produced in 2022. In June 2021, Merck announced a procurement agreement with the U.S. government under which Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government upon EUA or approval from the FDA, which will be delivered in scheduled increments. This procurement of molnupiravir will be supported in whole or in part with federal funds. Additionally, Merck has entered into supply and advance purchase commitments for molnupiravir with other governments worldwide, including Australia, South Korea and New Zealand pending regulatory authorization, as well as the U.K., and is currently in discussions with other governments. If approved, Merck will be the principal on sales transactions, recognizing sales and related costs, with profit sharing amounts recorded within Cost of sales. Profits from the collaboration will be split equally between the partners.
Merck is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and intends to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic. As part of its commitment to widespread global access, Merck has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers. Merck and the Medicines Patent Pool (MPP) also signed a voluntary licensing agreement to facilitate affordable global access for molnupiravir. Under the terms of the agreement, the MPP will be permitted to further license non-exclusive sublicenses to manufacturers and diversify the manufacturing base for the supply of quality-assured or WHO-prequalified molnupiravir to countries covered by the MPP license, subject to local regulatory authorization. Merck, Ridgeback Bio and Emory University will not receive royalties for sales of molnupiravir under this agreement (molnupiravir was invented at Emory University and licensed to Ridgeback Bio) for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization. These agreements will help expand access to molnupiravir in more than 100 low- and middle-income countries.
In March 2021, Merck announced it had entered into multiple agreements to support efforts to expand manufacturing capacity and supply of SARS-CoV-2/COVID-19 medicines and vaccines. The Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response
within the U.S. Department of Health and Human Services, will provideprovided Merck with $102 million of funding in the first quarter of 2022 to adapt and make available a number of existing manufacturing facilities for the production of SARS-CoV-2/COVID-19 vaccines and medicines. The funding was recognized as a reduction to Cost of sales over the production period through September 30, 2022, offsetting the depreciation expense related to the amounts that were capitalized in connection with the modification of the manufacturing facilities. Merck has also entered intoand Johnson & Johnson have commenced an arbitration regarding a dispute concerning two agreements pursuant to supportwhich Merck was supporting the manufacturing and supply of Johnson & Johnson’s SARS-CoV-2/COVID-19 vaccine. Merck will use its facilitiesCOVID 19 vaccine and vaccine drug product. The amounts included in the U.S. to produce drug substance, formulatecondensed consolidated financial statements for these agreements were immaterial for the third quarter and fill vialsfirst nine months of Johnson & Johnson’s vaccine.2022. Merck does not believe the outcome of the arbitration will have a material impact on the Company’s financial results.
Pricing
Global efforts toward health care cost containment continue to exert pressure on product pricing and market access worldwide. Changes to the U.S. health care system enacted in prior years as part of health care reform, as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries, have contributed to pricing pressure. In several international markets, government-mandated pricing actions have reduced prices of generic and patented drugs. In addition, the Company’s sales performance in the first nine months of 20212022 was negatively affected by other cost-reduction measures taken by governments and other third parties to lower health care costs. In the U.S., Congress recently passed the Biden AdministrationInflation Reduction Act, which makes significant changes to how drugs are covered and Congress continue to discuss legislation designed to control health care costs,paid for under the Medicare
program, including the costcreation of drugs.financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug benefits, and government price-setting for certain Medicare Part D drugs, starting in 2026, and Medicare Part B drugs starting in 2028. The Company anticipates all of these actions and additional actions in the future will continue to negatively affect sales performance.and profits.
Supply Chain
As a result of global macroeconomic conditions, the Company is experiencing some disruption and volatility in its global supply chain network, and the Company may in the future experience disruptions in availability and delays in shipments of raw materials and packaging, as well as related cost inflation.
Operating Results
Sales
| | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange |
($ in millions) | ($ in millions) | 2021 | | 2020 | | % Change | | 2021 | | 2020 | | % Change | | ($ in millions) | 2022 | | 2021 | | % Change | | 2022 | | 2021 | | % Change | |
United States | United States | $ | 6,276 | | | $ | 5,250 | | | 20 | % | | 20 | % | | $ | 16,166 | | | $ | 14,301 | | | 13 | % | | 13 | % | United States | $ | 7,322 | | | $ | 6,276 | | | 17 | % | | 17 | % | | $ | 20,927 | | | $ | 16,166 | | | 29 | % | | 29 | % |
International | International | 6,878 | | | 5,679 | | | 21 | % | | 18 | % | | 19,017 | | | 16,269 | | | 17 | % | | 13 | % | International | 7,637 | | | 6,878 | | | 11 | % | | 19 | % | | 24,526 | | | 19,017 | | | 29 | % | | 35 | % |
Total | Total | $ | 13,154 | | | $ | 10,929 | | | 20 | % | | 19 | % | | $ | 35,183 | | | $ | 30,570 | | | 15 | % | | 13 | % | Total | $ | 14,959 | | | $ | 13,154 | | | 14 | % | | 18 | % | | $ | 45,453 | | | $ | 35,183 | | | 29 | % | | 32 | % |
U.S. plus international may not equal total due to rounding.
Worldwide sales grew 20%14% to $13.2$15.0 billion in the third quarter of 2021 and rose 15%2022 primarily due to $35.2 billion in the first nine months of 2021. Revenue performance in both periods primarily reflects higher sales in the oncology franchise, largely driven by strong growth of Keytruda (pembrolizumab) and increased alliance revenue from Reblozyl (luspatercept-aamt) and Lynparza (olaparib), as well as higher sales in the virology franchise driven by Lagevrio (molnupiravir). Also contributing to revenue growth in the third quarter of 2022 were higher sales in the vaccines franchise, primarily attributable to growth of Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) and Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), as well as higher sales of hospital acute care products, including Bridion (sugammadex) Injection and Zerbaxa (ceftolozane and tazobactam). Higher revenue related to third-party manufacturing arrangements also contributed to revenue growth in the third quarter of 2022.
Worldwide sales rose 29% to $45.5 billion in the first nine months of 2022. Revenue growth was attributable in part to higher sales in the virology franchise driven by Lagevrio. Also contributing to revenue growth in the first nine months of 2022 were higher sales in the oncology franchise largely driven by strong growth of Keytruda and increased alliance revenue from Lenvima (lenvatinib), Reblozyl and Lynparza, as well as higher sales in the vaccines franchise, primarily attributable to growth inof Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant)/Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Varivax (Varicella Virus Vaccine Live) and ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live).9. Higher sales of certain hospital acute care products, including Bridion (sugammadex) Injection and Prevymis Zerbaxa(letermovir), as well as higher sales of Animal Health productsrevenue related to third-party manufacturing arrangements also drove revenue growth in the first nine months of 2022.
As discussed above, COVID-19-related disruptions had some negative effects on sales in the third quarter and first nine months of 2022, but to a lesser extent than in the same periods of 2021 which benefited year-over-year sales growth in both periods.
Revenue growth in the third quarter and first nine months of 2021. Additionally, sales in the third quarter and first nine months of 2021 also benefited from the achievement of milestones for an out-licensed product that triggered contingent payments to Merck. As discussed above, the COVID-19 pandemic unfavorably affected sales in the third quarter and first nine months of 2021, but to a lesser extent than in the comparable periods of 2020 which benefited year-over-year sales growth.
Revenue growth in both periods2022 was partially offset by lower combined sales of diabetes products Januvia (sitagliptin) and Janumet (sitagliptin and metformin HCl), lower sales of Pneumovax 23 (pneumococcal vaccine polyvalent) and the suspension oflower sales of hospital acute care productvirology products ZerbaxaIsentress/Isentress HD (ceftolozane(raltegravir). Lower revenue from the receipt of upfront and tazobactam)milestone payments for injection. Lower sales of diabetes product Janumet (sitagliptin/metformin HCl)out-licensing arrangements also partially offset revenuesales growth in the third quarter and first nine months of 2021.2022.
See Note 16 to the condensed consolidated financial statements for details on sales of the Company’s products. A discussion of performance for select products in the franchises follows.
Pharmaceutical Segment
Oncology
| | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange |
($ in millions) | ($ in millions) | 2021 | | 2020 | | % Change | | 2021 | | 2020 | | % Change | | ($ in millions) | 2022 | | 2021 | | % Change | | 2022 | | 2021 | | % Change | |
Keytruda | Keytruda | $ | 4,534 | | | $ | 3,715 | | | 22 | % | | 21 | % | | $ | 12,609 | | | $ | 10,387 | | | 21 | % | | 19 | % | Keytruda | $ | 5,426 | | | $ | 4,534 | | | 20 | % | | 26 | % | | $ | 15,487 | | | $ | 12,609 | | | 23 | % | | 28 | % |
Alliance Revenue - Lynparza (1) | Alliance Revenue - Lynparza (1) | 246 | | | 196 | | | 25 | % | | 25 | % | | 721 | | | 519 | | | 39 | % | | 35 | % | Alliance Revenue - Lynparza (1) | 284 | | | 246 | | | 16 | % | | 23 | % | | 825 | | | 721 | | | 14 | % | | 20 | % |
Alliance Revenue - Lenvima (1) | Alliance Revenue - Lenvima (1) | 188 | | | 142 | | | 32 | % | | 30 | % | | 498 | | | 421 | | | 18 | % | | 15 | % | Alliance Revenue - Lenvima (1) | 202 | | | 188 | | | 7 | % | | 11 | % | | 660 | | | 498 | | | 33 | % | | 36 | % |
Alliance Revenue - Reblozyl | | Alliance Revenue - Reblozyl | 39 | | | — | | | — | | — | | 124 | | | — | | | — | | — |
(1) Alliance revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs (see Note 4 to the condensed consolidated financial statements).
Keytruda is an anti-PD-1 (programmed death receptor-1) therapy that has been approved as monotherapy for the treatment of certain patients with cervical cancer, classical Hodgkin lymphoma, (cHL), cutaneous squamous cell carcinoma, (cSCC),endometrial carcinoma, esophageal cancer, gastric or gastroesophageal junction adenocarcinoma,(GEJ) carcinoma, head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), non-small-cell lung cancer (NSCLC),NSCLC, melanoma, Merkel cell carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer (solid tumors) including MSI-H/dMMR colorectal cancer, primary mediastinal large B-cell lymphoma, tumor mutational burden-high (TMB-H) solid tumors,cancer (solid tumors), and urothelial carcinoma including non-muscle invasive bladder cancer. Additionally, Keytruda is approved as monotherapy for the adjuvant treatment of certain patients with renal cell carcinoma (RCC) or stage IIB, IIC or III melanoma. Keytruda is also approved for certain patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. In addition, Keytruda is approved for the treatment of certain patients in combination with chemotherapy for metastatic squamous and nonsquamous NSCLC, in combination with chemotherapy, with or without bevacizumab for cervical cancer, in combination with chemotherapy for esophageal cancer, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for human epidermal growth factor 2 (HER-2)-positive gastric cancer,or GEJ adenocarcinoma, in combination with chemotherapy for HNSCC, in combination with chemotherapy for triple-negative-breast cancer (TNBC),metastatic TNBC, in combination with axitinib for renal cell carcinoma (RCC),advanced RCC, and in combination with Lenvima for both endometrial carcinoma and RCC. The Keytruda clinical development program includes studies across a broad range of cancer types. See “Research and Development Update” below.
Global sales of Keytruda grew 22%20% and 21%23% in the third quarter and first nine months of 2021,2022, respectively. Sales growth in both periods was primarily driven by higher demand as the Company continues to launch Keytruda with multiple new indications globally, although the COVID-19 pandemic had a dampening effect on growing demand negatively affecting the number of new patients starting treatment.globally. Sales in the U.S. continue to build across the multiple approved metastatic indications, in particular for the treatment of advanced NSCLC as monotherapy,certain types of RCC, HNSCC, and in combination with chemotherapy for both nonsquamous and squamous metastatic NSCLC, along with uptakeMSI-H cancers. Keytruda sales growth in the U.S. also benefited from increased uptake across recent launches in earlier-stage indications including in high-risk, early stage TNBC, as well as certain types of RCC TNBC, MSI-H cancer, esophageal cancer and HNSCC indications.melanoma. Keytruda sales growth in international markets was driven byreflects continued uptake predominately for the NSCLC, HNSCC and RCC indications, particularly in Europe. Sales growth in the third quarter and first nine months of 2021 was partially offset by lower pricing in Europe, China and Japan.
In March 2021, the FDA approved Keytruda forreceived the treatment of certain patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiationfollowing regulatory approvals thus far in combination with chemotherapy. The approval was based on the results of the KEYNOTE-590 trial.2022.
In May 2021, the FDA approved Keytruda in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive gastric or gastroesophageal junction adenocarcinoma based on the results of the KEYNOTE-811 trial. This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
In July 2021, the FDA approved Keytruda for the treatment of patients with high-risk, early-stage TNBC in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the KEYNOTE-522 trial. Additionally, the FDA converted the accelerated approval of Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 that was originally granted in 2020 to a full (regular) approval based on confirmatory data from KEYNOTE-522.
Also in July 2021, the FDA approved Keytruda as monotherapy for the treatment of patients with locally advanced cSCC that is not curable by surgery or radiation based on data from the KEYNOTE-629 trial.
Additionally, in July 2021, the FDA approved the combination of Keytruda plus Lenvima for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. The approval for this population is based on results from the KEYNOTE-775/Study 309 trial, which was the confirmatory trial for the accelerated approval by the FDA in 2019.
In August 2021, Merck announced a label update for Keytruda for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. The FDA has converted this indication from an accelerated to a full (regular) approval. | | | | | |
Date | Approval |
January 2022 | European Commission (EC) approval as monotherapy for the adjuvant treatment of adults with RCC at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, based on the KEYNOTE-564 trial. |
February 2022 | Japan Ministry of Health, Labour and Welfare (MHLW) approval of the combination of Keytruda plus Lenvima for radically unresectable or metastatic RCC, based on the CLEAR (Study 307)/KEYNOTE-581 trial. |
February 2022 | Japan Pharmaceuticals and Medical Devices Agency approval for the treatment of adult patients with advanced or recurrent TMB-H solid tumors that have progressed after chemotherapy (limited to use when difficult to treat with standard of care) based on the KEYNOTE-158 trial. |
March 2022 | U.S. Food and Drug Administration (FDA) approval as a single agent for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, based on the KEYNOTE-158 trial (Cohorts D & K). |
April 2022 | EC approval in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer in certain adults whose tumors express PD-L1, based on the KEYNOTE-826 trial. |
April 2022 | EC approval as monotherapy for the treatment of certain adult patients with unresectable or metastatic MSI-H/dMMR colorectal, gastric, small intestine or biliary cancer, as well as advanced or recurrent MSI-H/dMMR endometrial cancer, based on the KEYNOTE-164 and KEYNOTE-158 trials. |
In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.
Also in August 2021, the FDA approved the combination of Keytruda and Lenvima for the first-line treatment of adult patients with advanced RCC based on results from the KEYNOTE-581 trial/Study 307 trial.
In October 2021, the FDA approved Keytruda in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer based on the KEYNOTE-826 trial. Additionally, the FDA converted the accelerated approval of Keytruda as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy to a regular approval based on confirmatory data from KEYNOTE-826. This approval was originally granted in June 2018 based on results from the KEYNOTE-158 trial.
In March 2021, Merck announced it was voluntarily withdrawing the U.S. indication for Keytruda for the treatment of patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The withdrawal of this indication was done in consultation with the FDA and does not affect other indications for Keytruda. Accelerated approval for this indication was granted in 2019 and was contingent upon completion of the post-marketing requirement establishing superiority of Keytruda as determined by overall survival (OS). As announced in January 2020, KEYNOTE-604, the confirmatory Phase 3 trial for this indication, met one of its dual primary endpoints of progression-free survival (PFS) but did not reach statistical significance for the other primary endpoint of OS.
In July 2021, Merck announced that it plans to voluntarily withdraw the U.S. accelerated approval indication for Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, with disease progression on or after two or more prior lines of therapy. The decision was made in consultation with the FDA following the Oncologic Drugs Advisory Committee evaluation of this third-line gastric cancer indication for Keytruda as a monotherapy because it failed to meet its post-marketing requirement of demonstrating an OS benefit in a Phase 3 study. The withdrawal of this indication was done in consultation with the FDA and does not affect other indications for Keytruda. As agreed with the FDA, Merck will initiate the withdrawal in January 2022.
In January 2021, Keytruda was approved by the European Commission (EC) as a first-line treatment in adult patients with MSI-H or dMMR colorectal cancer based on the results of the KEYNOTE-177 study.
In March 2021, the EC approved an expanded label for Keytruda as monotherapy for the treatment of adult and pediatric patients aged 3 years and older with relapsed or refractory cHL who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. This approval is based on results from the KEYNOTE-204 and KEYNOTE-087 trials. This is the first pediatric approval for Keytruda in the European Union (EU).
In May 2021, the EC approved the addition of the 400 mg every six weeks (Q6W) dosing regimen to indications where Keytruda is administered in combination with other anticancer agents.
Also in May 2021, the EC approved an update to the European label for Keytruda to include data from KEYNOTE-361. In the EU, Keytruda is approved for the treatment of adult patients with advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1. This approval was based on KEYNOTE-052; KEYNOTE-361 was conducted as part of a post-marketing commitment following the initial approval of Keytruda for these patients.
In June 2021, the EC approved Keytruda in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER2-negative gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1. This approval was based on results from the KEYNOTE-590 trial.
In October 2021, the EC approved Keytruda in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic TNBC in adults whose tumors express PD-L1 and who have not received prior chemotherapy for metastatic disease based on the KEYNOTE-355 trial.
In August 2021, Keytruda received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency: for the treatment of patients with PD-L1-positive, hormone receptor-negative and HER2-negative, inoperable or recurrent breast cancer, based on the results of the KEYNOTE-355 trial; and as a monotherapy for the treatment of patients with unresectable, advanced or recurrent MSI-H colorectal cancer, based on results of the KEYNOTE-177 trial.
In June 2021, Keytruda was approved by the China National Medical Products Administration (NMPA) as a first-line treatment in adult patients with MSI-H or dMMR colorectal cancer that is KRAS, NRAS and BRAF (all wild-type) based on the results of the KEYNOTE-177 study. In September 2021, Keytruda was approved by the China NMPA in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction based on the KEYNOTE-590 trial.
| | | | | |
May 2022 | EC approval in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage TNBC at high risk of recurrence, based on the KEYNOTE-522 trial. |
June 2022 | EC approval as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection, based on the KEYNOTE-716 trial. Additionally, EC approval expanding the indications in advanced (unresectable or metastatic) melanoma and stage III melanoma with lymph node involvement (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older. |
September 2022 | Japan MHLW approval in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for patients with hormone receptor-negative and HER2-negative breast cancer at high risk of recurrence, based on the KEYNOTE-522 trial. |
September 2022 | Japan MHLW approval as monotherapy for the adjuvant treatment of certain patients with RCC at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, based on the KEYNOTE-564 trial. |
September 2022 | Japan MHLW approval in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with advanced or recurrent cervical cancer with no prior chemotherapy who are not amenable to curative treatment, based on the KEYNOTE-826 trial. |
September 2022 | Japan MHLW approval as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection, based on the KEYNOTE-716 trial. |
Lynparza is an oral poly (ADP-ribose) polymerase (PARP) inhibitor being developed as part of a collaboration with AstraZeneca PLC (AstraZeneca) (see Note 4 to the condensed consolidated financial statements). Lynparza is approved for the treatment of certain types of advanced ovarian, breast, pancreatic and prostate cancers. Alliance revenue related to Lynparza increased 25%16% and 39%14% in the third quarter and first nine months of 2021, respectively. Sales growth in both periods was2022, respectively, largely driven by continued uptakehigher demand globally across the multiple approved indications, particularly in the U.S. and Europe. Higher demand in China also contributedlargely attributable to sales growthuptake in the year-to-date period.earlier-stage breast cancer indication following recent approval by the FDA. In June 2021,March 2022, Lynparza was granted conditional approval in China as monotherapyapproved by the FDA for the adjuvant treatment of certain previously treated adult patients with germlinedeleterious or somaticsuspected deleterious germline BRCA-mutated, metastatic castration-resistant prostateHER2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy, followed by approvals in the EU and Japan in August 2022, based on the results ofOlympiA trial. In September 2022, Lynparza was approved in China as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency-positive status. This approval was based on the PROfoundPAOLA-1 trial.
Lenvima is an oral receptor tyrosine kinase inhibitor being developed as part of a collaboration with Eisai Co., Ltd. (Eisai) (see Note 4 to the condensed consolidated financial statements). Lenvima is approved for the treatment of certain types of thyroid cancer, RCC, HCC, in combination with everolimus for certain patients with RCC, in combination with Keytruda for the treatment of certain patients with endometrial carcinoma, and in combination with Keytruda for the treatment of certain patients withboth endometrial carcinoma and RCC. Alliance revenue related to Lenvima grew 32%7% and 18%33% in the third quarter and first nine months of 2021, respectively. Sales growth in both periods reflects higher demand in China and the U.S.
In June 2021, Koselugo (selumetinib) was granted conditional approval2022, respectively, reflecting uptake in the EU foradvanced RCC and advanced endometrial carcinoma indications, particularly in the treatment of pediatric patients three years of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas based on positive results fromU.S. Growth in the National Cancer Institute Cancer Therapy Evaluation Program-sponsored SPRINT Stratum 1 trial. Koselugothird quarter was approvedpartially offset by the FDAtiming of shipments in April 2020. KoselugoChina.
Reblozyl is part of the same collaboration with AstraZeneca referenced above that includes Lynparza.
In August 2021, the FDA approved Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery. The approval was based on results from the open-label Study 004 trial. Welireg wasa first-in-class erythroid maturation recombinant fusion protein obtained as part of Merck’s 2019November 2021 acquisition of Peloton Therapeutics,Acceleron Pharma Inc. (Peloton). Pursuantthat is being developed and commercialized through a global collaboration with Bristol Myers Squibb (see Note 4 to the acquisition agreement,condensed consolidated financial statements). Reblozyl is approved for the treatment of certain types of anemia. Merck maderecorded alliance revenue of $39 million (consisting of royalties) in the third quarter of 2022 related to this collaboration. Merck recorded alliance revenue of $124 million in the first nine months of 2022, which includes royalties of $104 million, as well as the receipt of a $50 million capitalizedregulatory approval milestone payment to former Peloton shareholders upon first commercial sale of Welireg in the U.S.$20 million.
Vaccines
| | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange |
($ in millions) | ($ in millions) | 2021 | | 2020 | | % Change | | 2021 | | 2020 | | % Change | | ($ in millions) | 2022 | | 2021 | | % Change | | 2022 | | 2021 | | % Change | |
Gardasil/Gardasil 9 | Gardasil/Gardasil 9 | $ | 1,993 | | | $ | 1,187 | | | 68 | % | | 63 | % | | $ | 4,144 | | | $ | 2,941 | | | 41 | % | | 35 | % | Gardasil/Gardasil 9 | $ | 2,294 | | | $ | 1,993 | | | 15 | % | | 20 | % | | $ | 5,428 | | | $ | 4,144 | | | 31 | % | | 35 | % |
ProQuad | ProQuad | 244 | | | 218 | | | 12 | % | | 12 | % | | 598 | | | 507 | | | 18 | % | | 17 | % | ProQuad | 264 | | | 244 | | | 8 | % | | 10 | % | | 640 | | | 598 | | | 7 | % | | 9 | % |
M-M-R II | M-M-R II | 127 | | | 115 | | | 11 | % | | 10 | % | | 295 | | | 287 | | | 3 | % | | 2 | % | M-M-R II | 124 | | | 127 | | | (2) | % | | (1) | % | | 330 | | | 295 | | | 12 | % | | 14 | % |
Varivax | Varivax | 290 | | | 243 | | | 19 | % | | 19 | % | | 733 | | | 595 | | | 23 | % | | 23 | % | Varivax | 280 | | | 290 | | | (3) | % | | (2) | % | | 746 | | | 733 | | | 2 | % | | 3 | % |
RotaTeq | | RotaTeq | 256 | | | 227 | | | 12 | % | | 16 | % | | 644 | | | 593 | | | 9 | % | | 11 | % |
Pneumovax 23 | Pneumovax 23 | 277 | | | 375 | | | (26) | % | | (26) | % | | 600 | | | 748 | | | (20) | % | | (21) | % | Pneumovax 23 | 131 | | | 277 | | | (53) | % | | (50) | % | | 457 | | | 600 | | | (24) | % | | (21) | % |
RotaTeq | 227 | | | 210 | | | 8 | % | | 7 | % | | 593 | | | 601 | | | (1) | % | | (3) | % | |
WorldwideCombined worldwide sales of Gardasil/Gardasil and Gardasil 9, vaccines to help prevent certain cancers and other diseases caused by certain types of human papillomavirus (HPV), grew 68%15% and 41%31% in the third quarter and first nine months of 2021, respectively. Sales growth in both periods was2022, respectively, driven primarily by strong global demand outside of the U.S., particularly in China, which also benefited from increased supply, andsupply. Sales of Gardasil 9 in the U.S. which also benefited fromincreased in the timingthird quarter and first nine months of 2022 due to public sector purchases. Higher pricingbuying patterns.
China’s National Medical Products Administration expanded the use of Gardasil 9 for use in Chinagirls and the U.S. also contributedwomen ages 9 to sales growth45. The vaccine was previously approved for use in both periods.girls and women ages 16 to 26.
Global sales of ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a pediatric combination vaccine to help protect against measles, mumps, rubella and varicella, grew 12%increased 8% and 18%7% in the third quarter and first nine months of 2021,2022, respectively, primarily due to higher sales in the U.S. reflecting higher demand driven byin Europe and higher pricing in the ongoing COVID-19 pandemic recovery, as well as higher pricing.U.S.
Worldwide sales of M‑M‑R II (Measles, Mumps and Rubella Virus Vaccine Live), a vaccine to help protect against measles, mumps and rubella, grew 11% and 3%12% in the third quarter and first nine months of 2021, respectively,2022 primarily due to higher salespricing and demand in the U.S. reflecting the ongoing COVID-19 pandemic recovery inclusive of, as well as higher public sector mix of business. Lower demand and lower government tenders in international markets partially offset M‑M‑R II sales growth in both periods.Latin America.
Global sales of Varivax (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox (varicella), grew 19% and 23%2% in the third quarter and first nine months of 2021, respectively, primarily reflecting the ongoing COVID-19 pandemic recovery and higher pricing in the U.S. Higher government tenders in Brazil also contributed to Varivax sales growth for the first nine months of 2021.
Worldwide sales of Pneumovax 23, a vaccine2022 primarily attributable to help prevent pneumococcal disease, declined 26% and 20%higher pricing in the third quarter and first nine months of 2021, respectively, primarily drivenU.S., partially offset by lower demandtenders in the U.S. reflecting prioritization of COVID-19 vaccination.Latin America.
Global sales of RotaTeq (Rotavirus Vaccine, Live Oral, Pentavalent), a vaccine to help protect against rotavirus gastroenteritis in infants and children, grew 8%12% and 9% in the third quarter and first nine months of 2022, respectively, primarily due to public sector buying patterns and higher pricing in the U.S. Higher volumes in China also contributed to RotaTeq sales growth in the third quarter of 2021 largely attributable to higher public sector purchases in the U.S., partially offset by lower demand in certain international markets. 2022.
Worldwide sales of RotaTeqPneumovax 23, a vaccine to help prevent pneumococcal disease, declined 1%53% and 24% in the third quarter and first nine months of 20212022, respectively, primarily reflecting lower demand in certain international markets, partially offset by higher public sector purchasesthe U.S. as the market continues to shift toward newer adult pneumococcal conjugate vaccines following changes in the U.S.
In July 2021, the FDA approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the preventionrecommendations of invasive disease caused by 15 Streptococcus pneumoniae serotypes in adults 18 years of age and older. The approval was based on data from seven clinical studies assessing safety, tolerability, and immunogenicity in adults. In October 2021, the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) votedin 2021. The Company expects the decline in U.S. sales of Pneumovax 23 will continue. Lower demand in Europe also contributed to provisionally recommend vaccination either with a sequential regimenthe Pneumovax 23 sales declines in the third quarter and first nine months of 2022.
In June 2022, the FDA approved an expanded indication for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) to include use in infants and children. Vaxneuvance is now indicated for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older. The FDA’s approval was based on data from seven randomized, double-blind clinical studies assessing safety, tolerability and immunogenicity of Vaxneuvance followedin infants and children. Vaxneuvance was previously approved by the FDA in 2021 for use in adults 18 years of age and older. Also in June 2022, the CDC’s ACIP unanimously voted to include PneumovaxVaxneuvance 23, or withas a single doserecommended option for vaccination in infants and children, including routine use in children under 2 years of 20-valent pneumococcal conjugate vaccine both for adults 65 years and older and for adults ages 19 to 64 with certain underlying medical conditions.age. These provisional recommendations will be reviewedsubsequently were adopted by the director of the CDC and the U.S. Department of Health and Human Services, and final recommendations will become official when published in the CDC’s Morbidity and Mortality Weekly Report (MMWR). In September 2021, Merck announced a settlement and license agreement with Pfizer Inc., (Pfizer) resolving all worldwide patent infringement litigation relatedThe ACIP also unanimously voted to the use of Merck’s investigational and licensed pneumococcal conjugate vaccine (PCV) products, includinginclude Vaxneuvance. Under the terms of the agreement, Merck will make certain regulatory milestone payments to Pfizer, as well as royalty payments on the worldwide sales of its PCV products. The Company will pay royalties of 7.25% of net sales of all Merck PCV products through 2026; and 2.5% of net sales of all Merck PCV products from 2027 through 2035.
Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine), developed as part of a U.S.-based partnership between Merck and Sanofi Pasteur, is now available in the U.S.Vaccines for Children program. In October 2022, the EC approved an expanded indication for Vaxneuvance to include active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae) in infants, children sixand adolescents from 6 weeks through fourto less than 18 years of age. Vaxneuvance was previously approved for use in the EU for individuals 18 years of age to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due toolder. In September 2022, Haemophilus influenzaeVaxneuvance type b. In February 2021, the CDC’s ACIP included Vaxelis as a combination vaccine option in the CDC’s Recommended Child and Adolescent Immunization Schedule. Sales of Vaxelis in the U.S. are made through the U.S.-based Merck/Sanofi Pasteur partnership, the results of which are reflected in equity income from affiliates included in Other (income) expense, net. Supply sales to the partnership are recorded within Sales. Vaxelis is alsowas approved in the EU where it is marketed directly by Merck and Sanofi Pasteur.Japan for use in adult patients. Vaxneuvance remains under review in Japan for use in pediatric patients.
Hospital Acute Care
| | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange |
($ in millions) | ($ in millions) | 2021 | | 2020 | | % Change | | 2021 | | 2020 | | % Change | | ($ in millions) | 2022 | | 2021 | | % Change | | 2022 | | 2021 | | % Change | |
Bridion | Bridion | $ | 369 | | | $ | 320 | | | 16 | % | | 15 | % | | $ | 1,096 | | | $ | 843 | | | 30 | % | | 27 | % | Bridion | $ | 423 | | | $ | 369 | | | 15 | % | | 22 | % | | $ | 1,244 | | | $ | 1,096 | | | 13 | % | | 19 | % |
Prevymis | 96 | | | 77 | | | 23 | % | | 22 | % | | 270 | | | 200 | | | 35 | % | | 31 | % | |
Noxafil | 64 | | | 79 | | | (19) | % | | (20) | % | | 197 | | | 247 | | | (20) | % | | (23) | % | |
Zerbaxa | Zerbaxa | (2) | | | 43 | | | (105) | % | | (105) | % | | (11) | | | 112 | | | (110) | % | | (110) | % | Zerbaxa | 43 | | | (2) | | | * | | * | | 120 | | | (11) | | | * | | * |
*Calculation not meaningful.
Worldwide sales of Bridion, for the reversal of two types of neuromuscular blocking agents used during surgery, grew 16%15% and 30%13% in the third quarter and first nine months of 2021,2022, respectively, due to higher demand globally, particularly in the U.S. and Europe,, largely attributable in part to the COVID-19 pandemic recovery. Bridion was also approved by the FDA’s growing share among neuromuscular blockade reversal agents and an increase in June 2021 for pediatric patients aged 2 years and older undergoing surgery.
Worldwide sales of Prevymis, a medicine for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogenic hematopoietic stem cell transplant, grew 23% and 35% in the third quarter and first nine months of 2021, respectively, due to continued uptake since launch in several international markets, particularly in Europe and the U.S. Prevymis was approved by the EC in January 2018 and by the FDA in November 2017.
Global sales of Noxafil (posaconazole), an antifungal agent for the prevention of certain invasive fungal infections, declined 19% and 20% in the third quarter and first nine months of 2021, respectively, primarily due to generic competition in Europe, partially offset by higher demand in China. The patent that provided market exclusivity for Noxafil in a number of major European markets expired in December 2019. As a result, the Company is experiencing lower demand for Noxafil in these markets as a result of generic competition and expects the decline to continue.surgical procedures.
In December 2020, the Company temporarily suspended sales of Zerbaxa, a combination antibacterial and beta-lactamase inhibitor for the treatment of certain bacterial infections, and subsequently issued a product recall, following the identification of product sterility issues. The Company expects a phased resupply for Zerbaxa beginning with the U.S. marketthat was initiated in the fourth quarter of 2021.
Immunology
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | | | % Change Excluding Foreign Exchange |
($ in millions) | 2021 | | 2020 | | % Change | | | 2021 | | 2020 | | % Change | |
Simponi | $ | 203 | | | $ | 209 | | | (3) | % | | (5) | % | | $ | 619 | | | $ | 615 | | | 1 | % | | (5) | % |
Sales of Simponi (golimumab), a once-monthly subcutaneous treatment for certain inflammatory diseases (marketed by the Company in Europe, Russia and Turkey), declined 3% in the third quarter of 2021 and increased 1% in the first nine months of 2021. Excluding the effect of foreign exchange, sales performance in both periods was largely attributable to lower pricing in Company’s marketing territories in Europe, partially offset by higher volumes. Sales of Simponi are being unfavorably affected by biosimilar competition for competing products. The Company expects this competition will continue to unfavorably affect sales of Simponi.
The Company’s marketing rights with respect to Simponi will revert to Janssen Pharmaceuticals, Inc. in the second half of 2024.
Virology
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | | | % Change Excluding Foreign Exchange |
($ in millions) | 2021 | | 2020 | | % Change | | | 2021 | | 2020 | | % Change | |
Isentress/Isentress HD | $ | 189 | | | $ | 205 | | | (8) | % | | (7) | % | | $ | 590 | | | $ | 646 | | | (9) | % | | (9) | % |
Global combined sales of Isentress/Isentress HD (raltegravir), an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, declined 8% and 9% in the third quarter and first nine months of 2021, respectively, primarily due to competitive pressure particularly in Europe and the U.S. The Company expects competitive pressure for Isentress/Isentress HD to continue.has been completed during 2022.
Cardiovascular
| | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange |
($ in millions) | ($ in millions) | 2021 | | 2020 | | % Change | | 2021 | | 2020 | | % Change | | ($ in millions) | 2022 | | 2021 | | % Change | | 2022 | | 2021 | | % Change | |
Alliance Revenue - Adempas/Verquvo (1) | Alliance Revenue - Adempas/Verquvo (1) | $ | 100 | | | $ | 83 | | | 20 | % | | 20 | % | | $ | 248 | | | $ | 216 | | | 15 | % | | 15 | % | Alliance Revenue - Adempas/Verquvo (1) | $ | 88 | | | $ | 100 | | | (12) | % | | 12 | % | | $ | 258 | | | $ | 248 | | | 4 | % | | 4 | % |
Adempas | Adempas | 59 | | | 55 | | | 7 | % | | 8 | % | | 188 | | | 167 | | | 13 | % | | 7 | % | Adempas | 57 | | | 59 | | | (5) | % | | 12 | % | | 181 | | | 188 | | | (4) | % | | 8 | % |
(1) Alliance revenue represents Merck’s share of profits from sales in Bayer’s marketing territories, which are product sales net of cost of sales and commercialization costs (see Note 4 to the condensed consolidated financial statements).
Adempas (riociguat), a cardiovascular drug for the treatment of certain types of pulmonary arterial hypertension, is and Verquvo (vericiguat) are part of a worldwide collaboration with Bayer AG (Bayer) to market and develop soluble guanylate cyclase (sGC) modulators including Adempas (see Note 4 to the condensed consolidated financial statements). Alliance revenue fromAdempas is approved for the collaboration grew 20% and 15%treatment of certain types of pulmonary arterial hypertension. Verquvo was approved in the third quarter and first nine months of 2021, respectively. Revenue from the collaboration also includes sales of AdempasU.S. in Merck’s marketing territories, which grew 7% and 13% in the third quarter and first nine months of 2021, respectively, primarily reflecting higher demand.
In January 2021 the FDA approved Verquvo (vericiguat), an sGC stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and reduced ejection fraction. Verquvo was also approved in Japan in June 2021 and in the EU in July 2021. The approvals were based onAlliance revenue from the resultscollaboration declined 12% and grew 4% in the third quarter and first nine months of the VICTORIA trial.2022, respectively. Revenue also includes sales of Adempas and Verquvo in Merck’s marketing territories.
Virology
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | | | % Change Excluding Foreign Exchange |
($ in millions) | 2022 | | 2021 | | % Change | | | 2022 | | 2021 | | % Change | |
Lagevrio | $ | 436 | | | $ | — | | | — | | — | | $ | 4,859 | | | $ | — | | | — | | — |
Isentress/Isentress HD | 161 | | | 189 | | | (15) | % | | (11) | % | | 466 | | | 590 | | | (21) | % | | (17) | % |
Lagevriois part of the samean investigational oral antiviral COVID-19 medicine being developed in a collaboration with Bayer referenced above that includes Adempas.Ridgeback (see Note 4 to the condensed consolidated financial statements). Lagevrio has received multiple authorizations or approvals worldwide. Sales of Lagevrio were $436 million in the third quarter of 2022 primarily consisting of sales in Australia, South Korea, Japan and the United Kingdom (UK). Merck’s initial supply commitment of Lagevrio to the U.S. was fulfilled in the first quarter of 2022; therefore, there were no sales of Lagevrio in the U.S. in the second or third quarters of 2022. Sales of Lagevrio were $4.9 billion in the first nine months of 2022 primarily consisting of sales in the U.S., the UK, Japan and Australia. Merck has entered into advance purchase and supply agreements for Lagevrio in more than 40 markets. The Company expects full-year 2022 Lagevrio sales to be between $5.2 billion and $5.4 billion.
Global combined sales of
Isentress/Isentress HD
, an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, declined 15% and 21% in the third quarter and first nine months of 2022, respectively, primarily due to lower global demand, reflecting in part competitive pressure in Europe and the U.S. The Company expects competitive pressure for Isentress/Isentress HD to continue.Diabetes
| | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange |
($ in millions) | ($ in millions) | 2021 | | 2020 | | % Change | | 2021 | | 2020 | | % Change | | ($ in millions) | 2022 | | 2021 | | % Change | | 2022 | | 2021 | | % Change | |
Januvia/Janumet | Januvia/Janumet | $ | 1,339 | | | $ | 1,327 | | | 1 | % | | — | % | | $ | 3,895 | | | $ | 3,948 | | | (1) | % | | (4) | % | Januvia/Janumet | $ | 1,133 | | | $ | 1,339 | | | (15) | % | | (9) | % | | $ | 3,599 | | | $ | 3,895 | | | (8) | % | | (2) | % |
Worldwide combined sales of Januvia (sitagliptin) and Janumet, medicines that help lower blood sugar levels in adults with type 2 diabetes, declined 1%15% and 8% in the third quarter and first nine months of 2022, respectively, primarily reflecting the loss of exclusivity in several markets in Europe and the Asia Pacific region, as well as lower demand in the U.S. The sales decline in the first nine months of 2021 primarily due to continued pricing pressure and lower demand in the U.S., largely2022 was partially offset by higher demand in China, andincreased demand in Latin America.America reflecting in part higher government tenders, as well as the impact of a prior year unfavorable adjustment to rebate reserves in the U.S. The Company expectsanticipates U.S. pricing pressure to continue. Januvia and Janumetwill lose market exclusivity in the U.S. in January 2023. The supplementary patent certificates that provide market exclusivity forunfavorably affect sales of Januvia and Janumet in future periods. Januvia and Janumet lost patent exclusivity with respect to the sitagliptin compound patent in China in July 2022, although not with respect to the patent claiming the specific sitagliptin salt form, which expires in June 2024. In addition, the Company lost market
exclusivity with respect to Januvia in the EU expire in September 2022, and additional exclusivity afforded Janumet that expires in April 2023 respectively.is being challenged. The Company anticipates sales of Januvia and Janumet in these markets will decline substantially afterin future periods following the loss of exclusivity.
The Company will lose sitagliptin compound patent protection for Januvia and Janumet in the U.S. in January 2023. However, in September 2022, the U.S. Court of Appeals for the Federal Circuit ruled in favor of Merck in a patent challenge related to the specific sitagliptin salt form that is the active ingredient in Januvia and Janumet, affirming the May 2021 decision in Merck’s favor by the U.S. Patent Office in an inter partes review. Also in September 2022, the U.S. District Court for the Northern District of West Virginia ruled in favor of the Company in an infringement suit related to the same sitagliptin salt patent, as well as a Janumet formulation patent, finding both Merck patents valid and infringed. The rulings from the U.S. Court of Appeals and the U.S District Court in West Virginia provide Januvia and Janumet patent protection through May 2027; although Merck has settled with multiple generic companies, providing that these generic companies can bring their products to the market exclusivity.in May 2026 or earlier under certain circumstances. The decision from the U.S. District Court in West Virginia is under appeal to the U.S. Court of Appeals for the Federal Circuit. (See Note 9 to the condensed consolidated financial statements.)
Combined sales of Januvia and Janumet in China, Europe and the U.S. represented 10%, 21% and 34%, respectively, of total combined Januvia and Janumet sales for the first nine months of 2022.
In response to a request from a regulatory authority, Merck evaluated its sitagliptin-containing products for the presence of nitrosamines. Nitrosamines are organic compounds found at trace levels in water and food. Nitrosamines can also result from chemical reactions and can form in drugs either due to the drug’s manufacturing process, chemical structure, or the conditions in which the drugs are stored or packaged. The Company detected a nitrosamine identified as Nitroso-STG-19 (NTTP) in some batches of its sitagliptin-containing medicines. The Company has engaged with major health authorities around the world and has implemented additional quality controls to ensure its portfolio of sitagliptin-containing products meet health authorities’ interim acceptable NTTP limits for continuing distribution of product to the market. The Company does not anticipate any significant impact on supply of these medicines.
Animal Health Segment
| | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange | | Three Months Ended September 30, | | % Change Excluding Foreign Exchange | | Nine Months Ended September 30, | | % Change Excluding Foreign Exchange |
($ in millions) | ($ in millions) | 2021 | | 2020 | | % Change | | 2021 | | 2020 | | % Change | | ($ in millions) | 2022 | | 2021 | | % Change | | 2022 | | 2021 | | % Change | |
Livestock | Livestock | $ | 864 | | | $ | 758 | | | 14 | % | | 12 | % | | $ | 2,503 | | | $ | 2,145 | | | 17 | % | | 14 | % | Livestock | $ | 829 | | | $ | 864 | | | (4) | % | | 4 | % | | $ | 2,486 | | | $ | 2,503 | | | (1) | % | | 6 | % |
Companion Animal | Companion Animal | 553 | | | 462 | | | 20 | % | | 18 | % | | 1,804 | | | 1,390 | | | 30 | % | | 26 | % | Companion Animal | 542 | | | 553 | | | (2) | % | | 4 | % | | 1,834 | | | 1,804 | | | 2 | % | | 6 | % |
Sales of livestock products grew 14%declined 4% and 17%1% in the third quarter and first nine months of 2021, respectively,2022, respectively. Excluding the unfavorable effect of foreign exchange in both periods, livestock sales performance primarily due toreflects higher demand for ruminant products, including animal health intelligence solutions for animal identification, monitoring and traceability,pricing, as well as higherincreased demand for poultry and swineruminant products. Sales of companion animal products declined 2% in the third quarter of 2022 and grew 2% in first nine months of 2022. Excluding the unfavorable effect of foreign exchange in both periods, sales performance primarily reflects higher pricing and demand in the companion animal portfolio, led by the Bravecto (fluralaner) line of products, partially offset by lower sales of vaccines due to supply constraints. Sales of the Bravecto line of products represented approximately 20% of animal health sales in the first nine months of 2022.
Costs, Expenses and 30%Other
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | | | Nine Months Ended September 30, | | |
($ in millions) | 2022 | | 2021 | | % Change | | 2022 | | 2021 | | % Change |
Cost of sales | $ | 3,934 | | | $ | 3,450 | | | 14 | % | | $ | 13,530 | | | $ | 9,752 | | | 39 | % |
Selling, general and administrative | 2,520 | | | 2,336 | | | 8 | % | | 7,355 | | | 6,804 | | | 8 | % |
Research and development | 4,399 | | | 2,445 | | | 80 | % | | 9,773 | | | 9,177 | | | 6 | % |
Restructuring costs | 94 | | | 107 | | | (12) | % | | 288 | | | 487 | | | (41) | % |
Other (income) expense, net | 429 | | | (450) | | | * | | 1,576 | | | (1,007) | | | * |
| $ | 11,376 | | | $ | 7,888 | | | 44 | % | | $ | 32,522 | | | $ | 25,213 | | | 29 | % |
*Calculation not meaningful.
Cost of Sales
Cost of sales increased 14% and 39% in the third quarter and first nine months of 2021, respectively, primarily due to higher demand for parasiticides, including the Bravecto (fluralaner) line of products, as well as higher demand for vaccines.
Costs, Expenses and Other
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | | | Nine Months Ended September 30, | | |
($ in millions) | 2021 | | 2020 | | % Change | | 2021 | | 2020 | | % Change |
Cost of sales | $ | 3,450 | | | $ | 3,013 | | | 15 | % | | $ | 9,752 | | | $ | 8,589 | | | 14 | % |
Selling, general and administrative | 2,336 | | | 2,060 | | | 13 | % | | 6,804 | | | 6,336 | | | 7 | % |
Research and development | 2,445 | | | 3,349 | | | (27) | % | | 9,177 | | | 7,609 | | | 21 | % |
Restructuring costs | 107 | | | 113 | | | (5) | % | | 487 | | | 265 | | | 84 | % |
Other (income) expense, net | (450) | | | (312) | | | 44 | % | | (1,007) | | | (637) | | | 58 | % |
| $ | 7,888 | | | $ | 8,223 | | | (4) | % | | 25,213 | | | 22,162 | | | 14 | % |
Cost of Sales
2022, respectively. Cost of sales increased 15%includes $234 million and 14%$2.6 billion in the third quarter and first nine months of 2021, respectively.2022, respectively, related to the collaboration with Ridgeback for Lagevrio (see Note 4 to the condensed consolidated financial statements). Cost of sales also
includes the amortization of intangible assets recorded in connection with acquisitions, collaborations and licensing arrangements, which totaled $346$445 million and $403$346 million in the third quarter of 20212022 and 2020,2021, respectively, and $1.2$1.6 billion and $1.4$1.2 billion for the first nine months of 2021 and 2020, respectively. Costs in the first nine months of 2022 and 2021, alsorespectively. Amortization expense in the first nine months of 2022 and 2021 includes $250 million and $153 million, respectively, of cumulative catch-up amortization related to Merck’s collaborations with AstraZeneca and Bayer, respectively, (see Note 4 to the condensed consolidated financial statements). Additionally, costs in the first nine months of 2021 include charges of $225 million related to the discontinuation of COVID-19 development programs. Also included in cost of sales are expenses associated with restructuring activities which amounted to $48$54 million and $38$48 million in the third quarter of 2022 and 2021, respectively, and 2020, respectively,$167 million and $113 million and $131 million forin the first nine months of 20212022 and 2020,2021, respectively, including accelerated depreciation and asset write-offs related to the planned sale or closure of manufacturing facilities. Separation costs associated with manufacturing-related headcount reductions have been incurred and are reflected in Restructuring costs as discussed below.
Gross margin was 73.7% in the third quarter of 2022 compared with 73.8% in the third quarter of 2021 compared with 72.4% in the third quarter of 2020. The gross margin increase reflects lower amortization of intangible assets (noted above), as well as the favorable effect of product mix, partially offset by higher manufacturing costs, including asset write-offs.2021. Gross margin was 70.2% in the first nine months of 2022 compared with 72.3% in the first nine months of 2021 compared with 71.9%2021. The gross margin declines primarily reflect the impacts of higher revenue from third-party manufacturing arrangements and sales of Lagevrio, both of which have lower gross margins, as well as higher amortization of intangible assets (noted above). The gross margin declines were partially offset by the favorable effects of product mix and foreign exchange. The gross margin decline in the first nine months of 2020. The gross margin increase reflects lower amortization of intangible assets and the favorable effect of product mix,2022 was also partially offset by higher costs associated with COVID-19 development programs, including charges in 2021 related to the discontinuation of certain COVID-19 development programs, as well as the unfavorable effects of pricing pressure, higher manufacturing costs and foreign exchange.
Selling, General and Administrative
Selling, general and administrative (SG&A) expenses increased 13%8% in both the third quarter and 7%first nine months of 2022 primarily due to higher administrative costs, including compensation and benefits, as well as higher promotional spending and restructuring costs, partially offset by the favorable effect of foreign exchange.
Research and Development
Research and development (R&D) expenses increased to $4.4 billion and $9.8 billion in the third quarter and first nine months of 2022, respectively, from $2.4 billion and $9.2 billion in the third quarter and first nine months of 2021, respectively,respectively. The increase in both periods was primarily due to $887 million of intangible asset impairment charges related to ArQule, Inc. (see Note 8 to the condensed consolidated financial statements), higher administrative costs, including compensationcharges related to collaborations and benefits, higher promotional expenseslicensing arrangements, increased clinical development spending, increased investments in technology in support of the Company’s key growth pillars, as well as the unfavorable effectdigital enablement of foreign exchange. The COVID-19 pandemic contributed to lower spending in the prior year periods.
Research and Development
Research and development (R&D) expenses declined 27% in the third quarter of 2021 primarily due to lower upfront payments related to collaborations, partially offset by higher oncology and COVID-19 clinical development spending, increased investment in discoveryMerck’s research and early drug development,operations, as well as higher compensation and benefit costs.costs, partially offset by the favorable effect of foreign exchange. In addition, the increase in R&D expenses increased 21% in the first nine months of 2021 primarily due to higher upfront payments related to acquisitions and collaborations, as well as higher clinical development spending and increased investment in discovery research and early drug development. The COVID-19 pandemic contributed to lower spending2022 was partially offset by a $1.7 billion charge in the prior year periods.period related to the acquisition of Pandion Therapeutics, Inc. (Pandion).
R&D expenses are comprised of the costs directly incurred by Merck Research Laboratories (MRL), the Company’s research and development division that focuses on human health-related activities, which were $2.0 billion and $1.8 billion and $1.6 billion infor the third quarter of 2022 and 2021, respectively, and 2020, respectively,were $5.6 billion and $5.3 billion and $4.6 billion infor the first nine months of 20212022 and 2020,2021, respectively. Also included in R&D expenses are Animal Health research costs, licensing costs and costs incurred by other divisions in support of R&D activities, including depreciation, production and general and administrative, which in the aggregate were approximately $710 million$1.5 billion and $625$710 million for the third quarter of 2022 and 2021, respectively, and 2020, respectively,$3.2 billion and $2.1 billion for the first nine months of 2022 and $1.9 billion2021, respectively. The increase in these expenses in the third quarter and first nine months of 2022 compared with the same periods of 2021 largely reflects $690 million of upfront and option payments in the aggregate for collaborations and licensing agreements with Orion, Moderna and Orna. Additionally, R&D expenses in the first nine months of 20212022 include $887 million of intangible assets impairment charges and 2020, respectively. Additionally, R&D expenses in the first nine months of 2021 include a $1.7 billion charge for the acquisition of Pandion as noted above. R&D expensesSee Note 3 for additional information related to business development activity in the third quartercurrent and first nine months of 2020 include charges of $832 million related to transactions with Seagen Inc. (Seagen) (see Note 3 to the condensed consolidated financial statements).prior year.
Restructuring Costs
In 2019, Merck approved a new global restructuring program (Restructuring Program) as part of a worldwide initiative focused on further optimizing the Company’s manufacturing and supply network, as well as reducing its global real estate footprint. This program is a continuation of the Company’s plant rationalization and builds on prior restructuring programs and does not include any actions associated with the spin-off of Organon. As the Company continues to evaluate its global footprint and overall operating model, it subsequently identified additional actions under the Restructuring Program, and could identify further actions over time.programs. The actions currently contemplated under the Restructuring Program are expected to be substantially completed by the end of 2023, with the cumulative pretax costs to be incurred by the Company to implement the program estimated to be approximately $3.0$3.5 billion. The CompanyMerck expects to record charges of approximately $700$600 million in 2021for the full year of 2022 related to the Restructuring Program. The Company anticipates the actions under the Restructuring Program will result in annual net cost savings of approximately $900 million by the end of 2023.
Restructuring costs, primarily representing separation and other related costs associated with these restructuring activities, were $107$94 million and $113$107 million for the third quarter of 20212022 and 2020,2021, respectively, and were $487$288 million and $265$487 million for the first nine months of 20212022 and 2020,2021, respectively. Separation costs incurred were 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. Also included in restructuring costs are asset abandonment, facility shut-down and other related costs, as well as employee-related costs such as curtailment, settlement and termination charges associated with pension and other postretirement benefit plans and share-based compensation plan costs. For segment reporting, restructuring costs are unallocated expenses.
Additional costs associated with the Company’s restructuring activities are included in Cost of sales, Selling, general and administrative expenses and Research and development costs. The Company recorded aggregate pretax costs of $168$175 million and $185$168 million in the third quarter of 20212022 and 2020,2021, respectively, and $630$559 million and $500$630 million for the first nine months of 20212022 and 2020,2021, respectively, related to restructuring program activities (see Note 5 to the condensed consolidated financial statements).
Other (Income) Expense, Net
Other (income) expense, net, was $429 million of expense in the third quarter of 2022 compared with $450 million of income in the third quarter of 20212021. Other (income) expense, net, was $1.6 billion of expense for the first nine months of 2022 compared with $312 million$1.0 billion of income for the first nine months of 2021. The change in the third quarter of 2020both periods is primarily due to higher incomenet unrealized losses from investments in equity securities recorded in the third quarter and first nine months of 2022 compared with net largely related to higher realized and unrealized gains on certain investments, partially offset by higher pension settlement costs. Other income (expense), net, was $1.0 billion of income in the first nine months of 2021 compared with $637 million of income in the first nine months of 2020 primarily due to higher income from investments in equity securities net, largely related to higher realized and unrealized gains on certain investments including the disposition in 2021 of the Company’s ownership
interest in Preventice Solutions Inc. (Preventice) as a result of the acquisition of Preventice by Boston Scientific. The favorabilityrecorded in the year-to-date periodthird quarter and first nine months of 2021. The unfavorability in both periods was partially offset by higherlower pension settlement costs.
For details on the components of Other (income) expense, net, see Note 12 to the condensed consolidated financial statements.
| Segment Profits | Segment Profits | | Segment Profits | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions) | ($ in millions) | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions) | 2022 | | 2021 | | 2022 | | 2021 |
Pharmaceutical segment profits | Pharmaceutical segment profits | $ | 8,606 | | | $ | 7,026 | | | $ | 22,450 | | | $ | 19,235 | | Pharmaceutical segment profits | $ | 9,590 | | | $ | 8,606 | | | $ | 28,263 | | | $ | 22,450 | |
Animal Health segment profits | Animal Health segment profits | 505 | | | 459 | | | 1,629 | | | 1,347 | | Animal Health segment profits | 515 | | | 505 | | | 1,672 | | | 1,629 | |
Other non-reportable segment profits | — | | | (1) | | | — | | | 1 | | |
Other | Other | (3,845) | | | (4,778) | | | (14,109) | | | (12,175) | | Other | (6,522) | | | (3,845) | | | (17,004) | | | (14,109) | |
Income from continuing operations before taxes | $ | 5,266 | | | $ | 2,706 | | | $ | 9,970 | | | $ | 8,408 | | |
Income from Continuing Operations Before Taxes | | Income from Continuing Operations Before Taxes | $ | 3,583 | | | $ | 5,266 | | | $ | 12,931 | | | $ | 9,970 | |
Pharmaceutical segment profits are comprised of segment sales less standard costs, as well as SG&A expenses directly incurred by the segment. Animal Health segment profits are comprised of segment sales, less all cost of sales, as well as SG&A and R&D expenses directly incurred by the segment. For internal management reporting presented to the chief operating decision maker, Merck does not allocate the remaining cost of sales not included in segment profits as described above, R&D expenses incurred by MRL, 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 costs related to restructuring activities and acquisition and divestiture-related costs, including the amortization of intangible assets and amortization of purchase accounting adjustments, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. 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 (losses), as well as operating profits (losses) related to third-party manufacturing sales.arrangements.
Pharmaceutical segment profits increased 22%11% and 17%26% in the third quarter and first nine months of 2021, respectively, reflecting higher sales and the favorable effect of foreign exchange, partially offset by higher administrative and promotional costs. Animal Health segment profits grew 10% and 21% in the third quarter and first nine months of 2021,2022, respectively, reflecting higher sales, partially offset by higher administrative and promotional costs, as well as the unfavorable effect of foreign exchange. Animal Health segment profits grew 2% in the third quarter of 2022 reflecting favorable product mix, partially offset by the unfavorable effect of foreign exchange. Animal Health segment profits grew 3% in the first nine months of 2022 reflecting higher sales, partially offset by higher selling and administrative costs.costs and the unfavorable effect of foreign exchange.
Taxes on Income
The effective income tax rates from continuing operations were 13.2%9.2% and 14.0%13.2% for the third quarter of 20212022 and 2020,2021, respectively, and 14.4%11.0% and 15.1%14.4% for the first nine months of 20212022 and 2020,2021, respectively. The effective income tax rates from continuing operations reflect the beneficial impact of foreign earnings. The effective income tax rates from continuing operations in the third quarter and first nine months of 2021 reflect2022 also include the beneficialfavorable impact of net unrealized losses from investments in equity securities and intangible asset impairment charges, which were taxed at the settlement of a foreignU.S. tax matter.rate. The effective income tax rate from continuing operations forin the first nine months of 2021 reflects the unfavorable effect of a charge for the acquisition of Pandion for which no tax benefit was recognized, as well as a net tax benefit of $207 million related to the settlement of certain federal income tax matters as discussed below.
In the first quarter of 2021, the Internal Revenue Service (IRS) concluded its examinations of Merck’s 2015-2016 U.S. federal income tax returns. As a result, the Company was required to make a payment of $190 million (of which $172 million related to Merck continuing operations and $18 million related to Organon discontinued operations). The Company’s reserves for unrecognized tax benefits for the years under examination exceeded the adjustments relating to this examination period and therefore the Company recorded a $236 million net tax benefit in the first nine months of 2021 (of which $207 million related to Merck continuing operations and $29 million related to Organon discontinued operations). This net benefit reflects reductions in reserves for unrecognized tax benefits and other related liabilities for tax positions relating to the years that were under examination.
Non-GAAP Income and Non-GAAP EPS from Continuing Operations
Non-GAAP income and non-GAAP EPS are alternative views of the Company’s performance that Merck is providing because management believes this information enhances investors’ understanding of the Company’s results as it permits investorssince management uses non-GAAP measures to understand how management assessesassess performance. 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 (which should not be considered non-recurring) consist of acquisition and divestiture-related costs, restructuring costs, income and losses from investments in equity securities, and certain other items.
These excluded items are significant components in understanding and assessing financial performance. 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 a non-GAAP EPS.EPS metric. Management uses thesenon-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, senior management’s annual compensation is derived in part using a non-GAAP pretax income.income metric. 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. The information on non-GAAP income and non-GAAP EPS should be considered in addition to, but not as a substitute for or superior to, net income and EPS prepared in accordance with generally accepted accounting principles in the U.S. (GAAP).
In 2022, the Company changed the treatment of certain items for purposes of its non-GAAP reporting. Historically, Merck’s non-GAAP results excluded expenses for upfront and milestone payments related to collaborations and licensing agreements, as well as charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions, to the extent the charges were considered by the Company to be significant to the results of a particular period (as well as any related adjustments recorded in a subsequent period). Beginning in 2022, Merck’s non-GAAP results no longer exclude charges related to these items. Prior periods have been recast to conform to the current presentation.
A reconciliation between GAAP financial measures and non-GAAP financial measures (from continuing operations) is as follows:
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Three Months Ended September 30, | | Nine Months Ended September 30, |
($ in millions except per share amounts) | ($ in millions except per share amounts) | 2021 | | 2020 | | 2021 | | 2020 | ($ in millions except per share amounts) | 2022 | | 2021 | | 2022 | | 2021 |
Income from continuing operations before taxes as reported under GAAP | Income from continuing operations before taxes as reported under GAAP | $ | 5,266 | | | $ | 2,706 | | | $ | 9,970 | | | $ | 8,408 | | Income from continuing operations before taxes as reported under GAAP | $ | 3,583 | | | $ | 5,266 | | | $ | 12,931 | | | $ | 9,970 | |
Increase (decrease) for excluded items: | Increase (decrease) for excluded items: | | Increase (decrease) for excluded items: | |
Acquisition and divestiture-related costs | Acquisition and divestiture-related costs | 445 | | | 447 | | | 1,445 | | | 1,600 | | Acquisition and divestiture-related costs | 1,344 | | | 445 | | | 2,512 | | | 1,445 | |
Restructuring costs | Restructuring costs | 168 | | | 185 | | | 630 | | | 500 | | Restructuring costs | 175 | | | 168 | | | 559 | | | 630 | |
Income from investments in equity securities, net | (684) | | | (346) | | | (1,503) | | | (944) | | |
Loss (income) from investments in equity securities, net | | Loss (income) from investments in equity securities, net | 350 | | | (684) | | | 1,268 | | | (1,503) | |
Other items: | Other items: | | Other items: | |
Charge for the acquisition of Pandion | — | | | — | | | 1,704 | | | — | | |
Charges for the discontinuation of COVID-19 development programs | Charges for the discontinuation of COVID-19 development programs | — | | | — | | | 225 | | | — | | Charges for the discontinuation of COVID-19 development programs | — | | | — | | | — | | | 225 | |
Charges for the formation of collaborations (1) | — | | | 1,082 | | | — | | | 1,082 | | |
Other | (87) | | | (1) | | | (26) | | | (17) | | |
Non-GAAP income from continuing operations before taxes | Non-GAAP income from continuing operations before taxes | 5,108 | | | 4,073 | | | 12,445 | | | 10,629 | | Non-GAAP income from continuing operations before taxes | 5,452 | | | 5,195 | | | 17,270 | | | 10,767 | |
Taxes on income from continuing operations as reported under GAAP | Taxes on income from continuing operations as reported under GAAP | 695 | | | 380 | | | 1,436 | | | 1,271 | | Taxes on income from continuing operations as reported under GAAP | 330 | | | 695 | | | 1,423 | | | 1,436 | |
Estimated tax (expense) benefit on excluded items (2) | (30) | | | 272 | | | 86 | | | 411 | | |
Estimated tax benefit (provision) on excluded items (1) | | Estimated tax benefit (provision) on excluded items (1) | 414 | | | (29) | | | 965 | | | 84 | |
Net tax benefit from the settlement of certain federal income tax matters | Net tax benefit from the settlement of certain federal income tax matters | — | | | — | | | 207 | | | — | | Net tax benefit from the settlement of certain federal income tax matters | — | | | — | | | — | | | 207 | |
Adjustment to tax benefits recorded in conjunction with the 2015 Cubist Pharmaceuticals, Inc. acquisition | — | | | (67) | | | — | | | (67) | | |
Non-GAAP taxes on income from continuing operations | Non-GAAP taxes on income from continuing operations | 665 | | | 585 | | | 1,729 | | | 1,615 | | Non-GAAP taxes on income from continuing operations | 744 | | | 666 | | | 2,388 | | | 1,727 | |
Non-GAAP net income from continuing operations | Non-GAAP net income from continuing operations | 4,443 | | | 3,488 | | | 10,716 | | | 9,014 | | Non-GAAP net income from continuing operations | 4,708 | | | 4,529 | | | 14,882 | | | 9,040 | |
Less: Net income attributable to noncontrolling interests as reported under GAAP | Less: Net income attributable to noncontrolling interests as reported under GAAP | 4 | | | 2 | | | 9 | | | 1 | | Less: Net income attributable to noncontrolling interests as reported under GAAP | 5 | | | 4 | | | 6 | | | 9 | |
Non-GAAP net income from continuing operations attributable to Merck & Co., Inc. | Non-GAAP net income from continuing operations attributable to Merck & Co., Inc. | $ | 4,439 | | | $ | 3,486 | | | $ | 10,707 | | | $ | 9,013 | | Non-GAAP net income from continuing operations attributable to Merck & Co., Inc. | $ | 4,703 | | | $ | 4,525 | | | $ | 14,876 | | | $ | 9,031 | |
EPS from continuing operations assuming dilution as reported under GAAP | $ | 1.80 | | | $ | 0.92 | | | $ | 3.36 | | | $ | 2.81 | | |
EPS assuming dilution from continuing operations as reported under GAAP | | EPS assuming dilution from continuing operations as reported under GAAP | $ | 1.28 | | | $ | 1.80 | | | $ | 4.53 | | | $ | 3.36 | |
EPS difference | EPS difference | (0.05) | | | 0.45 | | | 0.86 | | | 0.74 | | EPS difference | 0.57 | | | (0.02) | | | 1.33 | | | 0.20 | |
Non-GAAP EPS from continuing operations assuming dilution | $ | 1.75 | | | $ | 1.37 | | | $ | 4.22 | | | $ | 3.55 | | |
Non-GAAP EPS assuming dilution from continuing operations | | Non-GAAP EPS assuming dilution from continuing operations | $ | 1.85 | | | $ | 1.78 | | | $ | 5.86 | | | $ | 3.56 | |
(1)Includes $832 million related to transactions with Seagen (see Note 3 to the condensed consolidated financial statements).
(2) The estimated tax impact on the excluded items is determined by applying the statutory rate of the originating territory of the non-GAAP adjustments.
Acquisition and Divestiture-Related Costs
Non-GAAP income and non-GAAP EPS exclude the impact of certain amounts recorded in connection with acquisitions and divestitures.divestitures of businesses. These amounts include the amortization of intangible assets and amortization of purchase accounting adjustments to inventories, as well as intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also excluded are integration, transaction, and certain other costs associated with acquisitions and divestitures.divestitures of businesses. Non-GAAP income and non-GAAP EPS also exclude amortization of intangible assets related to collaborations and licensing arrangements.
Restructuring Costs
Non-GAAP income and non-GAAP EPS exclude costs related to restructuring actions (see Note 5 to the condensed 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 asset, based upon the anticipated date the site will be closed or divested or the equipment disposed of, and depreciation expense as determined utilizing the useful life prior to the restructuring actions. Restructuring costs also include asset abandonment, facility shut-down and other related costs, as well as
employee-related costs such as curtailment, settlement and termination charges associated with pension and other postretirement benefit plans and share-based compensation costs.
Income and Losses from Investments in Equity Securities
Non-GAAP income and non-GAAP EPS exclude realized and unrealized gains and losses from investments in equity securities either owned directly or through ownership interests in investment funds.
Certain Other Items
Non-GAAP income and non-GAAP EPS exclude certain other items. These items are adjusted for after evaluating them on an individual basis, considering their quantitative and qualitative aspects. Typically, these consist of items that are unusual in nature, significant to the results of a particular period or not indicative of future operating results. Excluded from non-GAAP income and non-GAAP EPS in 2021 is a charge for the acquisition of Pandion,are charges related to the discontinuation of COVID-19 development programs (see Note 3 to the condensed consolidated financial statements) and a net tax benefit related to the settlement of certain federal income tax matters (see Note 13 to the condensed consolidated financial statements). Excluded from non-GAAP income and non-GAAP EPS in 2020 are upfront payments related to collaborations, including transactions with Seagen (see Note 3 to the condensed consolidated financial statements), and an adjustment to tax benefits recorded in conjunction with the 2015 Cubist Pharmaceuticals, Inc. acquisition.
Research and Development Update
The Company currently has several candidates under regulatory review in the U.S. and internationally.
MK-4482, (EIDD-2801)Lagevrio, molnupiravir, is an investigational oral antiviral medicine for the treatment of mild-to-moderatemild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. In October 2021,disease. Merck submitted an EUA application to the FDA for molnupiravir based on positive results from a planned interim analysis of the Phase 3 MOVe-OUT clinical trialis developing Lagevrio in which molnupiravir significantly reduced the risk of hospitalization or death in at risk, non-hospitalized adult patientscollaboration with mild-to-moderate COVID-19.Ridgeback. The FDA subsequently announced a November 30, 2021 meetinggranted Emergency Use Authorization for Lagevrio in December 2021; last reissued in October 2022, to authorize Lagevrio for the treatment of its Antimicrobial Drugs Advisory Committeemild to discuss the available data supporting the use of molnupiravir to treat mild-to-moderatemoderate COVID-19 in adults who have testedwith positive for COVID-19results of direct SARS-CoV-2 viral testing, and who are at high risk offor progression to severe COVID-19, including hospitalization or death.death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate. The authorization is based on the Phase 3 MOVe-OUT trial. Lagevrio is not approved for any use in the U.S. and is authorized only for the duration of the declaration that circumstances exist justifying the authorization of its emergency use under the Food, Drug and Cosmetic Act, unless the authorization is terminated or revoked sooner. Lagevrio has also received Conditional Marketing Authorization in the UK and Special Approval for Emergency in Japan. In November 2021, the European Medicines Agency (EMA) issued a positive scientific opinion for Lagevrio, which is intended to support national decision-making on the possible use of Lagevrio prior to marketing authorization. In October 2021, the EMA initiated a rolling review for molnupiravir.Lagevrio for the treatment of COVID-19 in adults. Merck plans to work with the CHMPCommittee for Medicinal Products for Human Use of the EMA to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application. Merck is developing molnupiravir in collaboration with Ridgeback Bio. The companies are actively working withApplications to other regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months. Molnupiravirbodies are underway. Lagevrio is also being evaluated for post-exposure prophylaxis in the Phase 3 MOVe-AHEAD trial, which is evaluating the efficacy and safety of molnupiravir in preventingLagevrio for the spreadprevention of COVID-19 within households. As previously announced,in adults who reside with a person with COVID-19.
In October 2022, Merck provided an update on new clinical and non-clinical studies of Lagevrio. A preliminary analysis of the University of Oxford’s PANORAMIC study, conducted in the UK in highly-vaccinated adults mostly over 65 years of age, showed no evidence of a difference between Lagevrio added to usual care compared to usual care alone for the reduction of hospitalizations and deaths through Day 28 (primary endpoint was not met); the incidence of hospitalizations and death through Day 28 was very low overall. The main secondary endpoint (time to first self-reported recovery) in the PANORAMIC study was 6 days shorter with the Lagevrio group compared to the usual care group; in addition, the use of Lagevrio also was associated with earlier recovery across a wide range of other symptom measures, as compared to the usual care group. Additionally, an analysis of real-world data from a separate study conducted by investigators in Israel (known as the MOVe-IN clinical trial indicatedClalit study) showed that molnupiravir is unlikelyin a cohort of non-hospitalized, high-risk patients, Lagevrio reduced hospitalizations and mortality due to demonstrateCOVID-19 in patients 65 years and above; no evidence of benefit was found in younger adults ages 40 to 64 years. Also, Merck reported results from a clinical benefitseparate, non-clinical 6-month carcinogenicity study in hospitalized patients, who generally had a longer duration of symptoms prior to study entry; therefore, the decisiontransgenic mice, which demonstrated that Lagevrio was made not to proceed to Phase 3.carcinogenic at any dose tested.
MK-7264, gefapixant, is an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough or unexplained chronic cough in adults under review by the FDA.FDA and EMA. The New Drug Application (NDA)marketing applications for gefapixant isare based on results from the COUGH-1 and COUGH-2 clinical trials. In July 2021,January 2022, the FDA informed Merckissued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant. In the CRL, the FDA requested additional information related to the cough counting system that was used to assess efficacy. The CRL was not related to the safety of its decisiongefapixant. The Company is performing additional analyses and anticipates submitting this information to extend the goal date forFDA in the NDAfirst half of 2023 in response to provide time for a fullthe CRL. The review of the submission. The extended Prescription Drug User Fee Act (PDUFA) date, or target action date, is March 21, 2022. Gefapixant is also under reviewperiod in the EU and Japan.
V114, Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine), is an investigational 15-valent pneumococcal conjugate vaccine under review byhas been extended pending the receipt of additional information from the Company. The Company plans to submit the information to the EMA for the prevention of invasive disease and pneumonia in adults. In October 2021, the EMA’s CHMP recommended the approval of Vaxneuvance for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The CHMP recommendation will now be reviewed by the EC for marketing authorization in the EU, and a final decision is expected by the endfirst half of 2021. The CHMP opinion was based on data from seven randomized, double-blind clinical studies evaluating2023.
MK-3475, Vaxneuvance in a variety of adult populations and clinical circumstances. The Company has several ongoing Phase 3 trials evaluating V114 in pediatric patients. In August 2021, Merck announced positive topline results from the pivotal Phase 3 PNEU-PED study evaluating the immunogenicity, safety, and tolerability of Vaxneuvance in infants and has submitted a supplemental licensure application to the FDA for pediatric use. V114 previously received Breakthrough Therapy designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age.
Keytruda, is an anti-PD-1 therapy approved for the treatment of many cancers that is in clinical development for expanded indications. These approvals were the result of a broad clinical development program that currently consists of more than 1,6001,650 clinical trials, including nearlymore than 1,200 trials that combine Keytruda with other cancer treatments. These studies encompass more than 30 cancer types including: biliary, tract, estrogen receptor positive breast cancer, cervical, colorectal, cutaneous squamous cell, endometrial, esophageal, gastric, glioblastoma, head and neck, hepatocellular, Hodgkin lymphoma, non-Hodgkin lymphoma, non-small-cell lung, small-cell lung, melanoma, mesothelioma, ovarian, prostate, renal, triple-
negativetriple-negative breast, and urothelial, many of which are currently in Phase 3 clinical development. Further trials are being planned for other cancers.
Keytruda is under priority review by the FDA for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection. This submission is based on data from the Phase 3 KEYNOTE-716 trial. In August 2021, Merck announced that the KEYNOTE-716 trial met its primary endpoint of recurrence-free survival for the adjuvant treatment of patients with surgically resected high-risk stage IIB and IIC melanoma. These results were presented at the European Society of Medical Oncology (ESMO) Congress in September 2021. The FDA set a PDUFA date of December 4, 2021. Keytruda is also under review in the EU for this indication.
Keytruda is also under priority review by the FDA for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney) or following nephrectomy and resection of metastatic lesions based on data from the Phase 3 KEYNOTE-564 trial. The FDA set a PDUFA date of December 10, 2021. Keytruda is also under review in the EU and Japan for this indication.
Additionally, Keytruda is under review by the FDA for the treatment of patients with previously treated advanced endometrial cancer that is MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.HCC. This submission is based on data from the KEYNOTE-158 trial.Phase 3 KEYNOTE-394 trial along with supportive data from the KEYNOTE-240 and KEYNOTE-224 trials. Keytruda is approved for this indication in the U.S. under the FDA’s accelerated approval process. This submission is to convert the accelerated approval to full (regular) approval.
Keytruda is also under review by the FDA for the adjuvant treatment of patients with stage IB (≥4 centimeters), II or IIIA NSCLC following complete surgical resection. The supplemental Biologics License Application is based on data from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. The FDA set a Prescription
Drug User Fee Act (PDUFA) date of January 29, 2023, however, further data may be provided during the review process that may delay this date. Keytruda is also under review for this indication in the EU.
In July 2022, Merck announced that the Phase 3 KEYNOTE-412 trial evaluating Keytruda with concurrent chemoradiation therapy (CRT) followed by Keytruda as maintenance therapy (the Keytruda regimen) did not meet its primary endpoint of event-free survival for the treatment of patients with unresected locally advanced HNSCC. At the final analysis of the study, there was an improvement in event-free survival for patients who received the Keytruda regimen compared to placebo plus CRT; however, these results did not meet statistical significance per the pre-specified statistical plan. Results were presented at the 2022 European Society for Medical Oncology (ESMO) congress.
In August 2022, Merck announced that the Phase 3 KEYNOTE-921 trial evaluating Keytruda in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of overall survival and radiographic progression-free survival for the treatment of patients with metastatic castration-resistant prostate cancer. In the study, there were modest trends toward an improvement in both overall survival and radiographic progression-free survival for patients who received Keytruda plus chemotherapy compared with chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. Results will be presented at an upcoming medical meeting.
MK-7339, Lynparza, is an oral PARP inhibitor currently approved for certain types of ovarian, breast, pancreatic and prostate cancers being co-developed for multiple cancer types as part of a collaboration with AstraZeneca.
In August 2022, the FDA granted priority review for a supplemental NDA for Lynparza in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer. The supplemental NDA was based on results from the Phase 3 PROpel trial, which were presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and later published in NEJM Evidence. The FDA set a PDUFA date in the fourth quarter of March 28, 2022.
Keytruda in combination with chemotherapy Lynparza is also under review in the EU and Japan for the treatment of certain patients with high-risk, early-stage TNBC as neoadjuvant treatment, and then as a single agent as adjuvent treatment after surgerymetastatic castration-resistant prostate cancer based on the KEYNOTE-522PROpel clinical trial.
Keytruda is under review in Japan in combination with chemotherapy forIn March 2022, Merck announced that it would stop the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER2-negative gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 based on the results from the KEYNOTE-590 trial.Phase 3 KEYLYNK-010 trial investigating
Additionally, Keytruda is under review in Japan for treatment of adult patients with advanced or recurrent TMB-H solid tumors that have progressed after chemotherapy (limited to use when difficult to treat with standard of care) based on the KEYNOTE-158 trial.
Keytruda in combination with platinum-basedLynparza for the treatment of patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy and either abiraterone acetate or enzalutamide. Merck has discontinued the study following the recommendation of an independent Data Monitoring Committee (DMC) after the DMC reviewed data from a planned interim analysis. At the interim analysis, the combination of Keytruda and Lynparza did not demonstrate a benefit in overall survival, one of the study’s dual primary endpoints, compared to the control arm of either abiraterone acetate or enzalutamide. The trial’s other dual primary endpoint, radiographic progression free survival, was evaluated at an earlier interim analysis and did not demonstrate improvement compared to the control arm. Results from the study were presented at the 2022 ESMO congress.
In July 2022, Merck announced it will stop the Phase 3 LYNK-003 trial investigating Lynparza with or without bevacizumab is also under review in Japan for the first-line treatment of patients with persistent, recurrentunresectable or metastatic cervicalcolorectal cancer based onwho have not progressed following first-line induction. This action follows the KEYNOTE-826 trial.recommendation of an independent DMC, after the DMC reviewed the data from a planned interim analysis. At the pre-specified interim analysis for progression-free survival, the efficacy of Lynparza as a monotherapy and in combination with bevacizumab relative to control met the criteria for futility by the DMC and accordingly, both experimental arms were discontinued. Data from this study will be shared in a future scientific forum.
MK-7902, Lenvima, is an oral receptor tyrosine kinase inhibitor being developed as part of a collaboration with Eisai. Merck and Eisai are studying the Keytruda plus Lenvima combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program.
In October 2021,August 2022, Merck and Eisai announced that the CHMPPhase 3 LEAP-002 trial investigating Keytruda plus Lenvima versus Lenvima monotherapy did not meet its dual primary endpoints of overall survival and progression-free survival as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). There were trends toward improvement in overall survival and progression-free survival for patients who received Keytruda plus Lenvima versus Lenvima monotherapy; however, these results did not meet statistical significance per the EMA adoptedpre-specified statistical plan. Results were presented at the 2022 ESMO congress.
In July 2020, Merck and Eisai announced that the FDA issued a positive opinion recommendingCRL regarding Merck’s and Eisai’s applications seeking accelerated approval of the combination of Keytruda plus Lenvima for the first-line treatment of adult patients with advanced RCCuHCC based on data from the Phase 1b KEYNOTE-524/Study 116 trial. Given the results of the LEAP-002 trial noted above, Merck no longer intends to pursue the application.
In October 2022, Merck announced positive top-line results from the pivotal Phase 3 KEYNOTE-581 trial/Study 307. The CHMP also adopted a positive opinion recommending approvalSTELLAR trial evaluating the safety and efficacy of Keytruda in combination with Lenvimasotatercept, an investigational activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein being evaluated as an add-on to stable background therapy for the treatment of adult patients with advanced or recurrent endometrial carcinoma who have disease progression following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation, based on data from the Phase 3 KEYNOTE-775 trial/Study 309. The CHMP’s recommendations will now be reviewed by the EC for marketing authorization in the EU and decisions are expected in the fourth quarter of 2021. Keytruda is also under review for both of these indications in Japan.
Merck and Eisai have stopped LEAP-007, the Phase 3 study evaluating the first-line treatment of Lenvima in combination with Keytruda in participants with metastatic squamous or non-squamous NSCLC, whose tumors are PD-L1 positive with no EGFR or ALK genomic tumor aberrations.pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1). The trial has been discontinued followingmet its primary efficacy outcome measure, demonstrating a statistically significant and
clinically meaningful improvement in 6-minute walk distance (6MWD, which measures how far patients can walk in 6 minutes). Eight of nine secondary efficacy outcome measures achieved statistical significance, including the recommendationoutcome measure of the external Data Monitoring Committee (eDMC) which met,proportion of participants achieving multicomponent improvement (defined as scheduled, to assess safetyimprovement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide level, and futility. The eDMC determined that the study had met the criteria for declaring futilityeither improvement in WHO Functional Class [FC] or maintenance of WHO FC II), and the benefit/risk profileoutcome measure of time to death or the combinationfirst occurrence of a clinical worsening event. The Cognitive/Emotional Impacts domain score of PAH-SYMPACT®, which was assessed as the ninth and final secondary outcome measure, did not support continuing the trial.
Merck and Eisai have closed LEAP-011 for further enrollment. LEAP-011 is a Phase 3 study evaluating Lenvima in combination with Keytruda for the first-line treatments of patients with platinum-ineligible urotherial carcinoma. Enrollment was closed following the recommendation of the eDMC, which met, as scheduled, to assess safety and futility. Dataachieve statistical significance. Results from the study will be presented at an upcoming medical meeting.scientific congress.
In September 2022, Merck announced it will initiate a new Phase 3 clinical program with once-daily islatravir for the treatment of people with HIV-1 infection. These new Phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL). One study will evaluate DOR/ISL in previously untreated adults with HIV-1 infection and two studies will evaluate DOR/ISL as a switch in antiretroviral therapy in adults with HIV-1 infection who are virologically suppressed. The investigational new drug application for the once-daily oral DOR/ISL treatment program remains under a partial clinical hold for any studies that would use doses higher than the dose to be studied in the new Phase 3 program. The Phase 2 clinical trial evaluating an investigational oral once-weekly combination treatment regimen of islatravir and Gilead Sciences’ lenacapavir in adults with HIV-1 infection who are virologically suppressed will resume under an amended protocol with a lower dose of islatravir. The investigational new drug application under which the islatravir + lenacapavir once-weekly treatment regimen is being investigated remains under a partial clinical hold for any studies that would use weekly oral islatravir doses higher than the doses considered for the revised clinical program. Additionally, Merck announced it will discontinue the development of once-monthly oral islatravir for pre-exposure prophylaxis (PrEP).In April 2021,June 2022, Merck announced the discontinuationpresentation of positive results from a Phase 1/2 study evaluating the safety, tolerability and immunogenicity of V116, the Company’s investigational 21-valent pneumococcal conjugate vaccine (PCV), in pneumococcal vaccine-naïve adults 18-49 years of age (Phase 1) and 50 years of age and older (Phase 2). In both populations, V116 met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to Pneumovax 23 across age groups. In April 2022, Merck announced that V116 received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older. The Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of MK-7110 (formerly known as CD24Fc)products intended for serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must indicate that the product may demonstrate substantial improvement over currently available options on at least one clinically significant endpoint. Enrollment in several Phase 3 trials evaluating V116 is ongoing.
In October 2022, Merck and Royalty Pharma plc (Royalty Pharma) entered into a funding arrangement under which wasRoyalty Pharma paid Merck $50 million to co-fund Merck’s development costs for a Phase 2b trial of MK-8189, an investigational oral Phosphodiesterase 10A (PDE10A) inhibitor, which is being evaluated for the treatment of hospitalized patients with COVID-19.schizophrenia. Under the agreement, Royalty Pharma has no rights to MK-8189 and has no decision-making authority over the program. If Merck acquired MK-7110 in December 2020 through its acquisitionelects to advance MK-8189 into a Phase 3 study, Royalty Pharma has the option to provide additional funding of OncoImmune, a privately held clinical-stage biopharmaceutical company. In 2021, Merck received feedback from the FDA that additional data would be needed to support a potential EUA application and therefore the Company did not expect MK-7110 would become available until the first half50% of 2022. Given this timeline and the technical, clinical and regulatory uncertainties, the availability of a number of medicines for patients hospitalized with COVID-19, and the need to concentrate Merck’s resources on accelerating the development and manufacture of the most viable therapeutics and vaccines, Merck decidedcosts up to discontinue development of MK-7110$375 million for the treatment of COVID-19. DuePhase 3 trial. If such additional funding is provided, Royalty Pharma becomes eligible to the discontinuation, the Company recorded charges of $207 million in the first nine months of 2021, which are reflected in Cost of sales and relate to fixed-asset and materials write-offs,receive future regulatory milestone payments contingent upon certain marketing approvals, as well as the recognition of liabilities for purchase commitments.
In September 2021, the FDA approved updated labeling for Steglatro, Steglujan and Segluromet, medicines for adults with type 2 diabetes, to include the primary efficacy and safety results from the VERTIS CV trial, which assessed the effect of Steglatro compared with placebo on cardiovascular outcomes in adult patients with type 2 diabetes and established atherosclerotic cardiovascular disease. The FDA issued a Complete Response Letter (CRL) concerning the Company’s application for a new indication, based on additional results from the VERTIS CV trial, to reduce the risk of hospitalization for heart failure. The Company is reviewing the CRL to assess next steps.royalties.
The chartcharts below reflectsreflect the Company’s research pipeline as of October 27, 2021.November 3, 2022. Candidates shown in Phase 3 include specific products and the date such candidate entered into Phase 3 development. Candidates shown in Phase 2 include the most advanced compound with a specific mechanism or, if listed compounds have the same mechanism, they are each currently intended for commercialization in a given therapeutic area. Small molecules and biologics are given MK-number designations and vaccine candidates are given V-number designations. Except as otherwise noted, candidates in Phase 1, additional indications in the same therapeutic area (other than with respect to cancer) and additional claims, line extensions or formulations for in-line products are not shown.
| | | | | | | | |
Phase 2 | Phase 3 (Phase 3 entry date) | Under Review |
Cancer MK-0482(2) Non-Small CellNon-Small-Cell Lung MK-1026 (nemtabrutinib) Hematological Malignancies MK-1308 (quavonlimab)(2) Non-Small-Cell Lung MK-1308A (quavonlimab+pembrolizumab) Advanced Solid Tumors
Colorectal Hepatocellular Melanoma Small-Cell Lung MK-2140 (zilovertamab vedotin) Breast Gastric Hematological Malignancies Non-Small-Cell Lung Ovarian Pancreatic MK-2870(1)(3) Neoplasm Malignant MK-3475 Keytruda Advanced Solid Tumors MK-4280 (favezelimab)(2) Hematological Malignancies Non-Small-Cell Lung MK-4280A (favezelimab+pembrolizumab) Esophageal Renal Cell Small-Cell Lung MK-4830(2) Colorectal Esophageal Melanoma Non-Small-Cell Lung Ovarian Renal Cell Small-Cell Lung MK-5684(1) Prostate MK-5890 (boserolimab)(2) Non-Small-Cell Lung Small-Cell Lung
| Cancer MK-6440 (ladiratuzumab vedotin)(1)(3) Breast Esophageal Gastric Head and Neck Melanoma Non-Small-Cell Lung Prostate Small-Cell Lung MK-6482 Welireg(3) Biliary Colorectal Endometrial Esophageal Hepatocellular Pancreatic Rare cancers Von Hippel-Lindau Disease-Associated Tumors (EU) MK-7119 Tukysa(1) Advanced Solid Tumors Biliary Tract Bladder Cervical Colorectal
Endometrial Gastric Non-Small-Cell Lung MK-7339 Lynparza(1)(3) Advanced Solid Tumors MK-7684 (vibostolimab)(2) Melanoma MK-7684A (vibostolimab+pembrolizumab) Biliary Breast Cervical Colorectal Endometrial Esophageal Head and Neck Hematological Malignancies Hepatocellular Prostate
| Cancer MK-7902 Lenvima(1)(2) Biliary Tract Glioblastoma Pancreatic Prostate Small-Cell Lung V937V940(1)
Breast
Cutaneous Squamous Cell
Head and Neck
Melanoma Solid Tumors
Cardiovascular
MK-2060
Chikungunya Virus Vaccine V184 Dengue Fever Virus Vaccine V181 HIV-1 Infection MK-8591B (islatravir+MK-8507)(4) MK-8591D (islatravir+lenacapavir)(1)(5)(1) Hypercholesterolemia MK-0616 Nonalcoholic Steatohepatitis (NASH) MK-3655 MK-6024 Overgrowth Syndrome MK-7075 (miransertib) Pneumococcal Vaccine Adult
V116
Pulmonary Arterial Hypertension MK-5475 Respiratory Syncytial VirusPulmonary Hypertension Due To Left Heart Disease
MK-1654MK-7962 (sotatercept)
Schizophrenia MK-8189(6) Thrombosis MK-2060 Treatment Resistant Depression MK-1942
|
| | | | | | | | |
Phase 3 (Phase 3 entry date) | Under Review |
Antiviral COVID-19 MK-4482 Lagevrio (U.S.) (May 2021)(1)(7) Cancer MK-1308A (quavonlimab+pembrolizumab) Renal Cell (April 2021) MK-3475 Keytruda Biliary Tract (September 2019) Cervical (October 2018) (EU)
Cutaneous Squamous Cell (August 2019) (EU) Gastric (May 2015) (EU) Hepatocellular (May 2016) (EU) Mesothelioma (May 2018) Ovarian (December 2018) Prostate (May 2019) Small-Cell Lung (May 2017) MK-3475 (pembrolizumab subcutaneous) Non-Small-Cell Lung (August 2021) MK-4280A (favezelimab+pembrolizumab) Colorectal (November 2021) Hematological Malignancies (October 2022) MK-6482 Welireg(3) Renal Cell (February 2020) MK-7119 Tukysa(1) Breast (October 2019) Colorectal (August 2022) MK-7339 Lynparza(1)(3) Colorectal (August 2020)
Non-Small-Cell Lung (June 2019) Small-Cell Lung (December 2020) MK-7684A (vibostolimab+pembrolizumab) Non-Small-Cell Lung (April 2021) Small-Cell Lung (March 2022) MK-7902 Lenvima(1)(2) Colorectal (April 2021) Esophageal (July 2021) Gastric (December 2020) Head and Neck (February 2020) Melanoma (March 2019) Non-Small-Cell Lung (March 2019) HIV-1 Infection MK-8591A (doravirine+islatravir) (February 2020)(5) HIV-1 PreventionPneumococcal Vaccine Adult
MK-8591 (islatravir) (FebruaryV116 (July 2022)
Pulmonary Arterial Hypertension MK-7962 (sotatercept) (January 2021)
Respiratory Syncytial Virus
MK-1654 (clesrovimab) (November 2021) | New Molecular Entities/Vaccines Antiviral COVID-19 MK-4482 (molnupiravir)Lagevrio (EU)(1) Cough MK-7264 (gefapixant) (U.S.)(4)(8) (EU) Cough
MK-7264 (gefapixant) (U.S.) (EU) (JPN)
Pneumococcal Vaccine Adult
V114 (EU) (JPN)
| Certain Supplemental Filings Cancer MK-3475 Keytruda • Resected Stage IIB and IIC MelanomaSecond-Line Hepatocellular Cancer (KEYNOTE-716)(KEYNOTE-394) (U.S.)
• Adjuvent Non-Small-Cell Lung Cancer (KEYNOTE-091) (U.S.) (EU)
MK-7339 Lynparza(1) • Adjuvent Renal CellFirst-Line Metastatic Prostate Cancer (KEYNOTE-564)(PROpel) (U.S.) (EU) (JPN)
• MSI-H or dMMR Endometrial Cancer
(KEYNOTE-158) (U.S.)
• High-Risk Early-Stage Triple-Negative Breast Cancer
(KEYNOTE-522) (EU) (JPN)
• Advanced Unresectable Metastatic Esophageal Cancer
(KEYNOTE-590) (JPN)
• Tumor Mutational Burden-High (KEYNOTE-158) (JPN)
• Cervical Cancer (KEYNOTE-826) (JPN)
MK-7902 Lenvima(1)(2)
• First-Line Metastatic Hepatocellular Carcinoma
(KEYNOTE-524) (U.S.)(5)
• Advanced Unresectable Renal Cell Carcinoma
(KEYNOTE-581) (EU) (JPN)
• Advanced Endometrial Cancer
(KEYNOTE-775) (EU) (JPN)
|
Footnotes: (1) Being developed in a collaboration. (2) Being developed in combination with Keytruda. (3) Being developed as monotherapy and/or in combination with Keytruda. (4) On FDA clinical hold. (5)Under review for On FDA partial clinical hold. (6) Phase 2b development costs are being co-funded. (7) Available in the U.S. under Emergency Use Authorization. (5)(8) In July 2020,response to the CRL received from the FDA issued a Complete Response Letter for Merck’sthis application in January 2022, Merck is performing additional analyses and Eisai’s applications. Merck and Eisai intend to submit additional data when availableanticipates submitting this information to the FDA.FDA in the first half of 2023.
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Liquidity and Capital Resources
| ($ in millions) | ($ in millions) | September 30, 2021 | | December 31, 2020 | ($ in millions) | September 30, 2022 | | December 31, 2021 |
Cash and investments | Cash and investments | $ | 10,451 | | | $ | 8,835 | | Cash and investments | $ | 12,232 | | | $ | 8,466 | |
Working capital | Working capital | 7,330 | | | 437 | | Working capital | 10,563 | | | 6,394 | |
Total debt to total liabilities and equity | Total debt to total liabilities and equity | 28.3 | % | | 34.7 | % | Total debt to total liabilities and equity | 28.4 | % | | 31.3 | % |
Cash provided by operating activities fromof continuing operations was $14.7 billion in the first nine months of 2022 compared with $8.0 billion in the first nine months of 2021 compared with $4.2 billion in the first nine months of 2020 reflecting stronger operating performance.performance, including the impact of Lagevrio (see Note 4 to the condensed consolidated financial statements). Cash provided by operating activities fromof continuing operations in the first nine months of 2021 includes $400 million2022 was reduced by $1.8 billion of milestone payments related to collaborations compared with $2.1 billion$432 million of milestone and option payments related to collaborations in the first nine months of 2020.2021. Cash provided by operating activities fromof continuing operations continues to be the Company’s primary source of funds to finance operating needs, with excess cash serving as the primary source of funds to finance capital expenditures, treasury stock purchases and dividends paid to shareholders.shareholders and treasury stock purchases. As a result of the mandatory change in R&D capitalization rules that are effective for tax years beginning after December 31, 2021 (related to the Tax Cuts and Jobs Act of 2017), the Company has paid higher taxes in the U.S. in the first nine months of 2022 compared with the same prior year period.
Cash used in investing activities of continuing operations was $3.2 billion in the first nine months of 2022 compared with $4.4 billion in the first nine months of 2021 compared with $4.5 billion in the first nine months of 2020.2021. The lower use of cash in investing activities of continuing operations was driven primarily bydue to lower cash used for acquisitions largely offset by lowerand higher proceeds from salesthe sale of securities and other investments, partially offset by higher purchases of securities and higher capital expenditures.other investments.
Cash used in financing activities of continuing operations was $7.6 billion in the first nine months of 2022 compared with $2.1 billion in the first nine months of 2021 compared with $4.2 billion2021. The increase in the first nine months of 2020. The lower use of cash used in financing activities of continuing operations was primarily driven bydue to the cash distribution in 2021 received from Organon in connection with the spin-off (see Note 2 to the condensed consolidated financial statements), lower coupled with higher payments on long-term debt (see below) and lower purchases of treasury stock, partially offset by lower proceeds from the issuance of debt (see below), a higher net decrease in short-term borrowings and higher dividends paid to shareholders.shareholders in the current period. The increase in cash used in financing activities was partially offset by net repayments of short-term borrowings and treasury stock purchases in the prior year period that did not occur in the current period.
Capital expenditures totaled $3.2 billion and $3.0 billion forin both the first nine months of 20212022 and 2020, respectively.the first nine months of 2021.
The Company has accounts receivable factoring agreements with financial institutions in certain countries to sell accounts receivable. The Company factored $2.4$2.3 billion and $2.1$2.8 billion of accounts receivable at September 30, 20212022 and December 31, 2020,2021, respectively, under these factoring arrangements, which reduced outstanding accounts receivable. The cash received from the financial institutions is reported within operating activities in the Condensed Consolidated Statement of Cash Flows. In certain of these factoring arrangements, for ease of administration, the Company will collect customer payments related to the factored receivables, which it then remits to the financial institutions. The net cash flows relating to these collections are reported as financing activities in the Condensed Consolidated Statement of Cash Flows.
Dividends paid to stockholders were $5.0$5.3 billion and $4.7$5.0 billion for the first nine months of 20212022 and 2020,2021, respectively. In May 2021,2022, the Board of Directors declared a quarterly dividend of $0.65$0.69 per share on the Company’s stock for the third quarter that was paid in July 2021.2022. In July 2021,2022, the Board of Directors declared a quarterly dividend of $0.65$0.69 per share on the Company’s stock for the fourth quarter that was paid in October 2021.2022.
In February 2022, the Company’s $1.25 billion, 2.35% notes matured in accordance with their terms and were repaid. In September 2022, the Company’s $1.0 billion, 2.40% notes matured in accordance with their terms and were repaid. In January 2021, the Company’s $1.15 billion, 3.875% notes matured in accordance with their terms and were repaid. In October 2021, the Company’s €1.0 billion, 1.125% notes matured in accordance with their terms and were repaid.
In February 2020, the Company’s $1.25 billion, 1.85% notes and $700 million floating-rate notes matured in accordance with their terms and were repaid.
In June 2020, the Company issued $4.5 billion principal amount of senior unsecured notes consisting of $1.0 billion of 0.75% notes due 2026, $1.25 billion of 1.45% notes due 2030, $1.0 billion of 2.35% notes due 2040 and $1.25 billion of 2.45% notes due 2050. Merck used the net proceeds from the offering for general corporate purposes, including without limitation the repayment of outstanding commercial paper borrowings and other indebtedness with upcoming maturities.
In 2018, Merck’s Board of Directors authorized purchases of up to $10 billion of Merck’s common stock for its treasury. The treasury stock purchase authorization has no time limit and will be made over time in open-market transactions, block transactions on or off an exchange, or in privately negotiated transactions. In May 2021, Merck restarted its share repurchase program, which the Company had temporarily suspended in March 2020. The Company purchased $822 million (11 million shares)did not purchase any shares of its common stock during the first nine months of 2021.2022. As of September 30, 2021,2022, the Company’s remaining share repurchase authorization was $5.1$5.0 billion.
The Company has a $6.0 billion credit facility that matures in June 2026. The facility provides backup liquidity for the Company’s commercial paper borrowing facility and is to be used for general corporate purposes. The Company has not drawn funding from this facility.
Critical Accounting Estimates
The Company’s significant accounting policies, which include management’s best estimates and judgments, are included in Note 2 to the consolidated financial statements for the year ended December 31, 20202021 included in Merck’s Form 10‑K filed on February 25, 2021.2022. See Note 1 to the condensed consolidated financial statements for information on the adoption of new accounting standards during 2021.2022. A discussion of accounting estimates considered critical because of the potential for a significant impact on the financial statements due to the inherent uncertainty in such estimates are disclosed in the Critical Accounting Estimates section of Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Merck’s Form 10-K. There have been no significant changes in the Company’s critical accounting estimates since December 31, 2020.2021.
Recently Issued Accounting Standards
For a discussion of recently issued accounting standards, see Note 1 to the condensed consolidated financial statements.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
There have been no material changes in market risk exposures that affect the disclosures presented in “Item 7A. Quantitative and Qualitative Disclosures about Market Risk” in the Company’s 20202021 Form 10-K filed on February 25, 2021.2022.
The economy of Turkey was recently determined to be hyperinflationary. Consequently, in accordance with U.S. GAAP, the Company’s monetary assets and liabilities that are subject to remeasurement as a result of the changes in the Turkish lira changed beginning in the second quarter of 2022. This change had an immaterial impact to Merck’s condensed 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 Company’s disclosure controls and procedures over financial reporting. Based on their evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that as of September 30, 2021,2022, the Company’s disclosure controls and procedures are effective. For the third quarter of 2021,2022, there were no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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 management’s 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, or negative variations of any of the foregoing. 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 Company’s growth strategy, financial results, product approvals, product potential, development programs, environmental or other sustainability initiatives, and may include statements related to the expected impact of the COVID-19 pandemic. One must carefully consider any such statement and should understand that many factors could cause actual results to differ materially from the Company’s 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 Company’s filings with the Securities and Exchange Commission, especially on Forms 10-K, 10-Q and 8-K. In Item 1A. “Risk Factors” of the Company’s Annual Report on Form 10‑K for the year ended December 31, 2020,2021, filed on February 25, 2021,2022, in the Company’s Form 10-Q for the quarterly period ended March 31, 2021,2022, filed on May 5, 2021, in2022, the Company’s Form 10-Q for the quarterly period ended June 30, 2021, as2022, filed on August 9, 2021,5, 2022, and in this Form 10-Q, 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.
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 Condensed Consolidated Financial Statements.
Item 1A. Risk Factors
For a discussion of risks that affect the Company’s business, please refer to Part I, Item IA, “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.2021. There have been no material changes to the risk factors as previously disclosed in the Company’s Annual Report on Form 10-K, except as follows:
The ongoing war between Russia and Ukraine and related global COVID-19 pandemic is having an adverse impact ondisruptions could adversely affect the Company’s business, operations and financial performance. The Company is unable to predict the full extent to which the pandemic and related impacts will continue to adversely impact its business, operations, financial performance, results of operations and financial condition.
The ongoing war between Russia and Ukraine, and the financial and economic sanctions imposed by the U.S., the European Union and other countries in response, are having pervasive direct and indirect effects on the global economy, and may adversely affect the Company’s business, results of operations and financial resultscondition. The Company is working cross-functionally across the globe to monitor and mitigate interruptions to business continuity resulting from the war, including its impact on Merck’s supply chain, operations and clinical trials.
For humanitarian reasons, the Company is continuing to supply essential medicines and vaccines in Russia while working to maintain compliance with evolving international sanctions. Merck is donating profits resulting from its operations in Russia to humanitarian causes. The Company does not have been negatively impacted byresearch or manufacturing facilities in Russia, currently does not plan to make further investments in Russia, and has suspended screening and enrollment in ongoing clinical trials as well as
planning for new studies in Russia, although the outbreakCompany continues to treat patients already enrolled in existing clinical trials and collect data from these studies. The Company is also using its resources to help alleviate the humanitarian crisis in Ukraine, including through donations of Coronavirus Disease 2019 (COVID-19). funds and products.
The duration, spread and severityfinancial impacts of the COVID-19 pandemic is uncertain, rapidly changingwar between Russia and difficultUkraine were immaterial to predict. Thethe Company’s consolidated financial statements for the third quarter and first nine months of 2022. However, the degree to which COVID-19 impactsthe war and related disruptions will impact the Company’s results for the remainder of 2022 or beyond is difficult to predict and will depend on future developments beyondoutside of the Company’s knowledge or control, including, but not limited to, the duration and spreadseverity of the outbreak, its severity,war, ongoing and additional financial and economic sanctions imposed by governments in response, restrictions on travel, regional instability, geopolitical shifts, and adverse effects on fuel and energy costs, supply chains, macroeconomic conditions, currency exchange rates and financial markets. Such developments may negatively impact the actions taken to containCompany directly or indirectly as well as the virus or treat its impact, and how quickly and to what extent normal economic and operating conditions can resume.
Merck continues to believe that global health systems and patients have largely adapted toparties with which the impactsCompany conducts business. In addition, the effects of the COVID-19 pandemic,war between Russia and that while negative impacts will persist, the trend will continue to improve. For the full year of 2021, Merck assumes a net unfavorable impact to sales of less than 3% due to the COVID-19 pandemic, all of which relates to the Pharmaceutical segment. To the extent these assumptions prove to be incorrect,Ukraine could heighten other risks disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, which could materially adversely affect the Company’s business, results may differ materially from the estimates set forth herein.
For the third quarterof operations and first nine months of 2021, the estimated negative impact of the COVID-19 pandemic to Merck’s sales was approximately $350 million and $1.3 billion, respectively, all of which related to the Pharmaceutical segment. Roughly 75% of Merck’s Pharmaceutical segment revenue is comprised of physician-administered products, which, despite strong underlying demand, have been affected by social distancing measures and fewer well visits.
Operating expenses reflect a minor positive effect in the third quarter and first nine months of 2021 as investments in COVID-19-related research programs largely offset the favorable impact of lower spending in other areas due to the COVID-19 pandemic.financial condition.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer purchases of equity securities for the three months ended September 30, 20212022 were as follows:
ISSUER PURCHASES OF EQUITY SECURITIES
| | | ($ in millions) | | ($ in millions) |
Period | Period | Total Number of Shares Purchased (1) | | Average Price Paid Per Share | | Approximate Dollar Value of Shares That May Yet Be Purchased Under the Plans or Programs (1) | Period | Total Number of Shares Purchased (1) | | Average Price Paid Per Share | | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs | | Approximate Dollar Value of Shares That May Yet Be Purchased Under the Plans or Programs (1) |
July 1 - July 31 | July 1 - July 31 | 1,636,842 | | | $77.33 | | $5,522 | July 1 - July 31 | — | | | $0.00 | | — | | | $5,047 |
August 1 - August 31 | August 1 - August 31 | 2,029,851 | | | $76.37 | | $5,367 | August 1 - August 31 | — | | | $0.00 | | — | | | $5,047 |
September 1 - September 30 | September 1 - September 30 | 4,104,249 | | | $73.35 | | $5,066 | September 1 - September 30 | — | | | $0.00 | | — | | | $5,047 |
Total | Total | 7,770,942 | | | $74.97 | | $5,066 | Total | — | | | $0.00 | | — | | |
(1) Shares purchasedThe Company did not purchase any shares during the period were made as part of athree months ended September 30, 2022 under the plan approved by the Board of Directors in October 2018 to purchase up to $10 billion of Merck’s common stock for its treasury.
Item 6. Exhibits
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31.1 | | — | |
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101.INS | — | XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document. |
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101.SCH | — | XBRL Taxonomy Extension Schema Document. |
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101.CAL | — | XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.DEF | — | XBRL Taxonomy Extension Definition Linkbase Document. |
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101.LAB | — | XBRL Taxonomy Extension Label Linkbase Document. |
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101.PRE | — | XBRL Taxonomy Extension Presentation Linkbase Document. |
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104 | | — | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
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.
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| | MERCK & CO., INC. |
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Date: November 5, 20213, 2022 | | /s/ Jennifer Zachary |
| | JENNIFER ZACHARY |
| | Executive Vice President and General Counsel and Corporate Secretary |
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Date: November 5, 20213, 2022 | | /s/ Rita A. Karachun |
| | RITA A. KARACHUN |
| | Senior Vice President Finance - Global Controller |