QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
(State or other jurisdiction of incorporation) | (I.R.S. Employer Identification No.) | |||||||
(Address of principal executive offices) (zip code) |
Not Applicable | ||||||||
(Former name, former address and former fiscal year, if changed since last report.) |
Securities Registered pursuant to Section 12(b) of the Act: | ||||||||
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
☒ | Accelerated filer | ☐ | |||||||||
Non-accelerated filer | ☐ | Smaller reporting company | |||||||||
Emerging growth company |
Page No. | ||||||||||||||
PART I | ||||||||||||||
Item 1. | ||||||||||||||
Item 2. | ||||||||||||||
Item 3. | ||||||||||||||
Item 4. | ||||||||||||||
PART II | ||||||||||||||
Item 1. | ||||||||||||||
Item 2. | ||||||||||||||
Item 6. | ||||||||||||||
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Sales | $ | $ | |||||||||
Costs, Expenses and Other | |||||||||||
Cost of sales | |||||||||||
Selling, general and administrative | |||||||||||
Research and development | |||||||||||
Restructuring costs | |||||||||||
Other (income) expense, net | |||||||||||
Income Before Taxes | |||||||||||
Taxes on Income | |||||||||||
Net Income | |||||||||||
Less: Net Income (Loss) Attributable to Noncontrolling Interests | ( | ||||||||||
Net Income Attributable to Merck & Co., Inc. | $ | $ | |||||||||
Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders | $ | $ | |||||||||
Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders | $ | $ |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Net Income Attributable to Merck & Co., Inc. | $ | $ | |||||||||
Other Comprehensive (Loss) Income Net of Taxes: | |||||||||||
Net unrealized (loss) gain on derivatives, net of reclassifications | ( | ||||||||||
Benefit plan net (loss) gain and prior service (cost) credit, net of amortization | ( | ||||||||||
Cumulative translation adjustment | ( | ||||||||||
( | |||||||||||
Comprehensive Income Attributable to Merck & Co., Inc. | $ | $ |
March 31, 2023 | December 31, 2022 | ||||||||||
Assets | |||||||||||
Current Assets | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Short-term investments | |||||||||||
Accounts receivable (net of allowance for doubtful accounts of $ and $ | |||||||||||
Inventories (excludes inventories of $ classified in Other assets - see Note 7) | |||||||||||
Other current assets | |||||||||||
Total current assets | |||||||||||
Investments | |||||||||||
Property, Plant and Equipment, at cost, net of accumulated depreciation of $ in 2023 and $ | |||||||||||
Goodwill | |||||||||||
Other Intangibles, Net | |||||||||||
Other Assets | |||||||||||
$ | $ | ||||||||||
Liabilities and Equity | |||||||||||
Current Liabilities | |||||||||||
Loans payable and current portion of long-term debt | $ | $ | |||||||||
Trade accounts payable | |||||||||||
Accrued and other current liabilities | |||||||||||
Income taxes payable | |||||||||||
Dividends payable | |||||||||||
Total current liabilities | |||||||||||
Long-Term Debt | |||||||||||
Deferred Income Taxes | |||||||||||
Other Noncurrent Liabilities | |||||||||||
Merck & Co., Inc. Stockholders’ Equity | |||||||||||
Common stock, $ Authorized - Issued - | |||||||||||
Other paid-in capital | |||||||||||
Retained earnings | |||||||||||
Accumulated other comprehensive loss | ( | ( | |||||||||
Less treasury stock, at cost: | |||||||||||
Total Merck & Co., Inc. stockholders’ equity | |||||||||||
Noncontrolling Interests | |||||||||||
Total equity | |||||||||||
$ | $ |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Cash Flows from Operating Activities | |||||||||||
Net income | $ | $ | |||||||||
Adjustments to reconcile net income to net cash provided by operating activities: | |||||||||||
Amortization | |||||||||||
Depreciation | |||||||||||
(Income) loss from investments in equity securities, net | ( | ||||||||||
Charge for the acquisition of Imago BioSciences, Inc. | |||||||||||
Deferred income taxes | ( | ( | |||||||||
Share-based compensation | |||||||||||
Other | ( | ||||||||||
Net changes in assets and liabilities | ( | ( | |||||||||
Net Cash Provided by Operating Activities | |||||||||||
Cash Flows from Investing Activities | |||||||||||
Capital expenditures | ( | ( | |||||||||
Purchases of securities and other investments | ( | ( | |||||||||
Proceeds from sales of securities and other investments | |||||||||||
Acquisition of Imago BioSciences, Inc., net of cash acquired | ( | ||||||||||
Other | |||||||||||
Net Cash Used in Investing Activities | ( | ( | |||||||||
Cash Flows from Financing Activities | |||||||||||
Payments on debt | ( | ( | |||||||||
Purchases of treasury stock | ( | ||||||||||
Dividends paid to stockholders | ( | ( | |||||||||
Proceeds from exercise of stock options | |||||||||||
Other | ( | ( | |||||||||
Net Cash Used in Financing Activities | ( | ( | |||||||||
Effect of Exchange Rate Changes on Cash, Cash Equivalents and Restricted Cash | ( | ||||||||||
Net (Decrease) Increase in Cash, Cash Equivalents and Restricted Cash | ( | ||||||||||
Cash, Cash Equivalents and Restricted Cash at Beginning of Year (includes restricted cash of $ | |||||||||||
Cash, Cash Equivalents and Restricted Cash at End of Period (includes restricted cash of $ and $ | $ | $ |
Three Months Ended March 31, | |||||||||||
($ in millions) | 2023 | 2022 | |||||||||
Alliance revenue - Lynparza | $ | $ | |||||||||
Alliance revenue - Koselugo | |||||||||||
Total alliance revenue | $ | $ | |||||||||
Cost of sales (1) | |||||||||||
Selling, general and administrative | |||||||||||
Research and development | |||||||||||
($ in millions) | March 31, 2023 | December 31, 2022 | |||||||||
Receivables from AstraZeneca included in Other current assets | $ | $ | |||||||||
Payables to AstraZeneca included in Accrued and other current liabilities (2) | |||||||||||
Payables to AstraZeneca included in Other Noncurrent Liabilities (2) |
Three Months Ended March 31, | |||||||||||
($ in millions) | 2023 | 2022 | |||||||||
Alliance revenue - Lenvima | $ | $ | |||||||||
Cost of sales (1) | |||||||||||
Selling, general and administrative | |||||||||||
Research and development | |||||||||||
($ in millions) | March 31, 2023 | December 31, 2022 | |||||||||
Receivables from Eisai included in Other current assets | $ | $ | |||||||||
Payables to Eisai included in Accrued and other current liabilities (2) |
Three Months Ended March 31, | |||||||||||
($ in millions) | 2023 | 2022 | |||||||||
Alliance revenue - Adempas/Verquvo | $ | $ | |||||||||
Net sales of Adempas recorded by Merck | |||||||||||
Net sales of Verquvo recorded by Merck | |||||||||||
Total sales | $ | $ | |||||||||
Cost of sales (1) | |||||||||||
Selling, general and administrative | |||||||||||
Research and development | |||||||||||
($ in millions) | March 31, 2023 | December 31, 2022 | |||||||||
Receivables from Bayer included in Other current assets | $ | $ | |||||||||
Payables to Bayer included in Accrued and other current liabilities |
Three Months Ended March 31, | |||||||||||
($ in millions) | 2023 | 2022 | |||||||||
Net sales of Lagevrio recorded by Merck | $ | $ | |||||||||
Cost of sales (1)(2) | |||||||||||
Selling, general and administrative (2) | |||||||||||
Research and development (2) | |||||||||||
($ in millions) | March 31, 2023 | December 31, 2022 | |||||||||
Payables to Ridgeback included in Accrued and other current liabilities (3) | $ | $ |
Three Months Ended March 31, 2023 | |||||||||||||||||||||||
($ in millions) | Separation Costs | Accelerated Depreciation | Other | Total | |||||||||||||||||||
Cost of sales | $ | $ | $ | $ | |||||||||||||||||||
Selling, general and administrative | |||||||||||||||||||||||
Restructuring costs | |||||||||||||||||||||||
$ | $ | $ | $ |
Three Months Ended March 31, 2022 | |||||||||||||||||||||||
($ in millions) | Separation Costs | Accelerated Depreciation | Other | Total | |||||||||||||||||||
Cost of sales | $ | $ | $ | $ | |||||||||||||||||||
Selling, general and administrative | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
Restructuring costs | |||||||||||||||||||||||
$ | $ | $ | $ |
($ in millions) | Separation Costs | Accelerated Depreciation | Other | Total | |||||||||||||||||||
Restructuring reserves January 1, 2023 | $ | $ | $ | $ | |||||||||||||||||||
Expenses | |||||||||||||||||||||||
(Payments) receipts, net | ( | ( | ( | ||||||||||||||||||||
Non-cash activity | ( | ( | ( | ||||||||||||||||||||
Restructuring reserves March 31, 2023 (1) | $ | $ | $ | $ |
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 March 31, | Three Months Ended March 31, | ||||||||||||||||||||||
($ in millions) | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||
Net Investment Hedging Relationships | |||||||||||||||||||||||
Foreign exchange contracts | $ | $ | ( | $ | $ | ( | |||||||||||||||||
Euro-denominated notes | ( |
March 31, 2023 | December 31, 2022 | |||||||||||||||||||||||||||||||||||||
Fair Value of Derivative | U.S. Dollar Notional | Fair Value of Derivative | U.S. Dollar Notional | |||||||||||||||||||||||||||||||||||
($ in millions) | Asset | Liability | Asset | Liability | ||||||||||||||||||||||||||||||||||
Derivatives Designated as Hedging Instruments | Balance Sheet Caption | |||||||||||||||||||||||||||||||||||||
Interest rate swap contracts | $ | $ | — | $ | $ | $ | — | $ | ||||||||||||||||||||||||||||||
Interest rate swap contracts | — | — | ||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | — | — | ||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | — | — | ||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | — | — | ||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | — | — | ||||||||||||||||||||||||||||||||||||
$ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||
Derivatives Not Designated as Hedging Instruments | Balance Sheet Caption | |||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | $ | $ | — | $ | $ | $ | — | $ | ||||||||||||||||||||||||||||||
Foreign exchange contracts | — | — | ||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | — | — | ||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | — | — | ||||||||||||||||||||||||||||||||||||
$ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||
$ | $ | $ | $ | $ | $ |
March 31, 2023 | December 31, 2022 | ||||||||||||||||||||||
($ in millions) | Asset | Liability | Asset | Liability | |||||||||||||||||||
Gross amounts recognized in the condensed consolidated balance sheet | $ | $ | $ | $ | |||||||||||||||||||
Gross amounts subject to offset in master netting arrangements not offset in the condensed consolidated balance sheet | ( | ( | ( | ( | |||||||||||||||||||
Cash collateral received/posted | ( | ( | ( | ||||||||||||||||||||
Net amounts | $ | $ | $ | $ |
Three Months Ended March 31, | |||||||||||||||||||||||||||||||||||
($ in millions) | 2023 | 2022 | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||||||||
Financial Statement Caption in which Effects of Fair Value or Cash Flow Hedges are Recorded | Sales | Other (income) expense, net (1) | Other comprehensive income (loss) | ||||||||||||||||||||||||||||||||
$ | $ | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||
(Gain) loss on fair value hedging relationships: | |||||||||||||||||||||||||||||||||||
Interest rate swap contracts | |||||||||||||||||||||||||||||||||||
Hedged items | — | — | ( | — | — | ||||||||||||||||||||||||||||||
Derivatives designated as hedging instruments | — | — | — | — | |||||||||||||||||||||||||||||||
Impact of cash flow hedging relationships: | |||||||||||||||||||||||||||||||||||
Foreign exchange contracts | |||||||||||||||||||||||||||||||||||
Amount of (loss) gain recognized in OCI on derivatives | — | — | — | — | ( | ||||||||||||||||||||||||||||||
Increase in Sales as a result of AOCL reclassifications | — | — | ( | ( | |||||||||||||||||||||||||||||||
Interest rate contracts | |||||||||||||||||||||||||||||||||||
Amount of gain recognized in Other (income) expense, net on derivatives | — | — | ( | ( | — | — | |||||||||||||||||||||||||||||
Amount of loss recognized in OCI on derivatives | — | — | — | — | ( | ( |
Amount of Derivative Pretax (Gain) Loss Recognized in Income | |||||||||||||||||
Three Months Ended March 31, | |||||||||||||||||
($ in millions) | 2023 | 2022 | |||||||||||||||
Derivatives Not Designated as Hedging Instruments | Income Statement Caption | ||||||||||||||||
Foreign exchange contracts (1) | Other (income) expense, net | $ | $ | ||||||||||||||
Foreign exchange contracts (2) | Sales | ( |
March 31, 2023 | December 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||
Amortized Cost | Gross Unrealized | Fair Value | Amortized Cost | Gross Unrealized | Fair Value | ||||||||||||||||||||||||||||||||||||||||||
($ in millions) | Gains | Losses | Gains | Losses | |||||||||||||||||||||||||||||||||||||||||||
Commercial paper | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
U.S. government and agency securities | |||||||||||||||||||||||||||||||||||||||||||||||
Corporate notes and bonds | |||||||||||||||||||||||||||||||||||||||||||||||
Foreign government bonds | |||||||||||||||||||||||||||||||||||||||||||||||
Total debt securities | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
Publicly traded equity securities (1) | |||||||||||||||||||||||||||||||||||||||||||||||
Total debt and publicly traded equity securities | $ | $ |
Fair Value Measurements Using | Fair Value Measurements Using | ||||||||||||||||||||||||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||||||||||||||||||||||
($ in millions) | March 31, 2023 | December 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||
Assets | |||||||||||||||||||||||||||||||||||||||||||||||
Investments | |||||||||||||||||||||||||||||||||||||||||||||||
Commercial paper | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
U.S. government and agency securities | |||||||||||||||||||||||||||||||||||||||||||||||
Foreign government bonds | |||||||||||||||||||||||||||||||||||||||||||||||
Publicly traded equity securities | |||||||||||||||||||||||||||||||||||||||||||||||
Other assets (1) | |||||||||||||||||||||||||||||||||||||||||||||||
U.S. government and agency securities | |||||||||||||||||||||||||||||||||||||||||||||||
Corporate notes and bonds | |||||||||||||||||||||||||||||||||||||||||||||||
Publicly traded equity securities | |||||||||||||||||||||||||||||||||||||||||||||||
Derivative assets (2) | |||||||||||||||||||||||||||||||||||||||||||||||
Purchased currency options | |||||||||||||||||||||||||||||||||||||||||||||||
Forward exchange contracts | |||||||||||||||||||||||||||||||||||||||||||||||
Interest rate swap contracts | |||||||||||||||||||||||||||||||||||||||||||||||
Total assets | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
Liabilities | |||||||||||||||||||||||||||||||||||||||||||||||
Other liabilities | |||||||||||||||||||||||||||||||||||||||||||||||
Contingent consideration | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
Derivative liabilities (2) | |||||||||||||||||||||||||||||||||||||||||||||||
Forward exchange contracts | |||||||||||||||||||||||||||||||||||||||||||||||
Written currency options | |||||||||||||||||||||||||||||||||||||||||||||||
Interest rate swap contracts | |||||||||||||||||||||||||||||||||||||||||||||||
Total liabilities | $ | $ | $ | $ | $ | $ | $ | $ |
($ in millions) | 2023 | 2022 | |||||||||
Fair value January 1 | $ | $ | |||||||||
Changes in estimated fair value (1) | ( | ||||||||||
Payments | ( | ( | |||||||||
Other | ( | ||||||||||
Fair value March 31 (2) | $ | $ |
($ in millions) | March 31, 2023 | December 31, 2022 | |||||||||
Finished goods | $ | $ | |||||||||
Raw materials and work in process | |||||||||||
Supplies | |||||||||||
Total (approximates current cost) | |||||||||||
Decrease to LIFO cost | ( | ( | |||||||||
$ | $ | ||||||||||
Recognized as: | |||||||||||
Inventories | $ | $ | |||||||||
Other Assets |
Three Months Ended March 31, | |||||||||||||||||||||||||||||
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) | Shares | Par Value | Shares | Cost | |||||||||||||||||||||||||
Balance at January 1, 2022 | $ | $ | $ | $ | ( | $ | ( | $ | $ | ||||||||||||||||||||
Net income attributable to Merck & Co., Inc. | — | — | — | — | — | — | — | ||||||||||||||||||||||
Other comprehensive income, net of taxes | — | — | — | — | — | — | — | ||||||||||||||||||||||
Cash dividends declared on common stock ($ | — | — | — | ( | — | — | — | — | ( | ||||||||||||||||||||
Share-based compensation plans and other | — | — | — | — | — | — | |||||||||||||||||||||||
Net loss attributable to noncontrolling interests | — | — | — | — | — | — | — | ( | ( | ||||||||||||||||||||
Balance at March 31, 2022 | $ | $ | $ | $ | ( | $ | ( | $ | $ | ||||||||||||||||||||
Balance at January 1, 2023 | $ | $ | $ | $ | ( | $ | ( | $ | $ | ||||||||||||||||||||
Net income attributable to Merck & Co., Inc. | — | — | — | — | — | — | — | ||||||||||||||||||||||
Other comprehensive loss, net of taxes | — | — | — | — | ( | — | — | — | ( | ||||||||||||||||||||
Cash dividends declared on common stock ($ | — | — | — | ( | — | — | — | — | ( | ||||||||||||||||||||
Treasury stock shares purchased | — | — | — | — | — | ( | — | ( | |||||||||||||||||||||
Share-based compensation plans and other | — | — | — | — | — | — | |||||||||||||||||||||||
Net income attributable to noncontrolling interests | — | — | — | — | — | — | — | ||||||||||||||||||||||
Balance at March 31, 2023 | $ | $ | $ | $ | ( | $ | ( | $ | $ |
Three Months Ended March 31, | |||||||||||||||||||||||
2023 | 2022 | ||||||||||||||||||||||
($ in millions) | U.S. | International | U.S. | International | |||||||||||||||||||
Service cost | $ | $ | $ | $ | |||||||||||||||||||
Interest cost | |||||||||||||||||||||||
Expected return on plan assets | ( | ( | ( | ( | |||||||||||||||||||
Amortization of unrecognized prior service credit | ( | ( | ( | ||||||||||||||||||||
Net (gain) loss amortization | ( | ||||||||||||||||||||||
Curtailments | |||||||||||||||||||||||
Settlements | |||||||||||||||||||||||
$ | $ | ( | $ | $ |
Three Months Ended March 31, | |||||||||||
($ in millions) | 2023 | 2022 | |||||||||
Service cost | $ | $ | |||||||||
Interest cost | |||||||||||
Expected return on plan assets | ( | ( | |||||||||
Amortization of unrecognized prior service credit | ( | ( | |||||||||
Net gain amortization | ( | ( | |||||||||
$ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||
($ in millions) | 2023 | 2022 | |||||||||
Interest income | $ | ( | $ | ( | |||||||
Interest expense | |||||||||||
Exchange losses | |||||||||||
(Income) loss from investments in equity securities, net (1) | ( | ||||||||||
Net periodic defined benefit plan (credit) cost other than service cost | ( | ( | |||||||||
Other, net | ( | ||||||||||
$ | $ |
Three Months Ended March 31, | |||||||||||
($ and shares in millions except per share amounts) | 2023 | 2022 | |||||||||
Net Income Attributable to Merck & Co., Inc. | $ | $ | |||||||||
Average common shares outstanding | |||||||||||
Common shares issuable (1) | |||||||||||
Average common shares outstanding assuming dilution | |||||||||||
Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders | $ | $ | |||||||||
Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders | $ | $ |
Three Months Ended March 31, | |||||||||||||||||||||||
($ in millions) | Derivatives | Employee Benefit Plans | Foreign Currency Translation Adjustment | Accumulated Other Comprehensive Loss | |||||||||||||||||||
Balance January 1, 2022, net of taxes | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||
Other comprehensive income (loss) before reclassification adjustments, pretax | ( | ||||||||||||||||||||||
Tax | ( | ( | ( | ( | |||||||||||||||||||
Other comprehensive income (loss) before reclassification adjustments, net of taxes | ( | ( | |||||||||||||||||||||
Reclassification adjustments, pretax | ( | (1) | (2) | ( | |||||||||||||||||||
Tax | ( | ||||||||||||||||||||||
Reclassification adjustments, net of taxes | ( | ( | |||||||||||||||||||||
Other comprehensive income (loss), net of taxes | ( | ||||||||||||||||||||||
Balance March 31, 2022, net of taxes | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||
Balance January 1, 2023, net of taxes | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||
Other comprehensive income (loss) before reclassification adjustments, pretax | ( | ( | ( | ||||||||||||||||||||
Tax | ( | ( | |||||||||||||||||||||
Other comprehensive income (loss) before reclassification adjustments, net of taxes | ( | ( | ( | ||||||||||||||||||||
Reclassification adjustments, pretax | ( | (1) | ( | (2) | ( | ||||||||||||||||||
Tax | |||||||||||||||||||||||
Reclassification adjustments, net of taxes | ( | ( | ( | ||||||||||||||||||||
Other comprehensive income (loss), net of taxes | ( | ( | ( | ||||||||||||||||||||
Balance March 31, 2023, net of taxes | $ | ( | $ | ( | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||||||||||||||||||||||||||
2023 | 2022 | ||||||||||||||||||||||||||||||||||
($ in millions) | U.S. | Int’l | Total | U.S. | Int’l | Total | |||||||||||||||||||||||||||||
Pharmaceutical: | |||||||||||||||||||||||||||||||||||
Oncology | |||||||||||||||||||||||||||||||||||
Keytruda | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||
Alliance revenue-Lynparza (1) | |||||||||||||||||||||||||||||||||||
Alliance revenue-Lenvima (1) | |||||||||||||||||||||||||||||||||||
Alliance revenue-Reblozyl (2) | |||||||||||||||||||||||||||||||||||
Welireg | |||||||||||||||||||||||||||||||||||
Vaccines | |||||||||||||||||||||||||||||||||||
Gardasil/Gardasil 9 | |||||||||||||||||||||||||||||||||||
ProQuad/M-M-R II/Varivax | |||||||||||||||||||||||||||||||||||
RotaTeq | |||||||||||||||||||||||||||||||||||
Vaxneuvance | |||||||||||||||||||||||||||||||||||
Pneumovax 23 | |||||||||||||||||||||||||||||||||||
Vaqta | |||||||||||||||||||||||||||||||||||
Hospital Acute Care | |||||||||||||||||||||||||||||||||||
Bridion | |||||||||||||||||||||||||||||||||||
Prevymis | |||||||||||||||||||||||||||||||||||
Primaxin | |||||||||||||||||||||||||||||||||||
Dificid | |||||||||||||||||||||||||||||||||||
Noxafil | |||||||||||||||||||||||||||||||||||
Zerbaxa | |||||||||||||||||||||||||||||||||||
Cardiovascular | |||||||||||||||||||||||||||||||||||
Alliance revenue-Adempas/Verquvo (3) | |||||||||||||||||||||||||||||||||||
Adempas | |||||||||||||||||||||||||||||||||||
Virology | |||||||||||||||||||||||||||||||||||
Lagevrio | ( | ||||||||||||||||||||||||||||||||||
Isentress/Isentress HD | |||||||||||||||||||||||||||||||||||
Neuroscience | |||||||||||||||||||||||||||||||||||
Belsomra | |||||||||||||||||||||||||||||||||||
Immunology | |||||||||||||||||||||||||||||||||||
Simponi | |||||||||||||||||||||||||||||||||||
Remicade | |||||||||||||||||||||||||||||||||||
Diabetes | |||||||||||||||||||||||||||||||||||
Januvia | |||||||||||||||||||||||||||||||||||
Janumet | |||||||||||||||||||||||||||||||||||
Other pharmaceutical (4) | |||||||||||||||||||||||||||||||||||
Total Pharmaceutical segment sales | |||||||||||||||||||||||||||||||||||
Animal Health: | |||||||||||||||||||||||||||||||||||
Livestock | |||||||||||||||||||||||||||||||||||
Companion Animals | |||||||||||||||||||||||||||||||||||
Total Animal Health segment sales | |||||||||||||||||||||||||||||||||||
Total segment sales | |||||||||||||||||||||||||||||||||||
Other (5) | |||||||||||||||||||||||||||||||||||
$ | $ | $ | $ | $ | $ |
Three Months Ended March 31, | |||||||||||
($ in millions) | 2023 | 2022 | |||||||||
United States | $ | $ | |||||||||
Europe, Middle East and Africa | |||||||||||
China | |||||||||||
Asia Pacific (other than China and Japan) | |||||||||||
Japan | |||||||||||
Latin America | |||||||||||
Other | |||||||||||
$ | $ |
Three Months Ended March 31, | |||||||||||
($ in millions) | 2023 | 2022 | |||||||||
Segment profits: | |||||||||||
Pharmaceutical segment | $ | $ | |||||||||
Animal Health segment | |||||||||||
Total segment profits | |||||||||||
Other profits | |||||||||||
Unallocated: | |||||||||||
Interest income | |||||||||||
Interest expense | ( | ( | |||||||||
Amortization | ( | ( | |||||||||
Depreciation | ( | ( | |||||||||
Research and development | ( | ( | |||||||||
Restructuring costs | ( | ( | |||||||||
Charge for Zetia antitrust litigation settlements | ( | ||||||||||
Other unallocated, net | ( | ( | |||||||||
$ | $ |
Three Months Ended March 31, | % Change Excluding Foreign Exchange | ||||||||||||||||||||||
($ in millions) | 2023 | 2022 | % Change | ||||||||||||||||||||
United States | $ | 6,659 | $ | 7,339 | (9) | % | (9) | % | |||||||||||||||
International | 7,828 | 8,563 | (9) | % | (2) | % | |||||||||||||||||
Total | $ | 14,487 | $ | 15,901 | (9) | % | (5) | % |
Three Months Ended March 31, | % Change Excluding Foreign Exchange | ||||||||||||||||||||||
($ in millions) | 2023 | 2022 | % Change | ||||||||||||||||||||
Keytruda | $ | 5,795 | $ | 4,809 | 20 | % | 24 | % | |||||||||||||||
Alliance Revenue - Lynparza (1) | 275 | 266 | 3 | % | 8 | % | |||||||||||||||||
Alliance Revenue - Lenvima (1) | 232 | 227 | 2 | % | 5 | % | |||||||||||||||||
Alliance Revenue - Reblozyl (2) | 43 | 52 | (19) | % | (19) | % | |||||||||||||||||
Welireg | 42 | 18 | * | * |
Date | Approval | ||||
January 2023 | FDA approval as a single agent for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC, based on the KEYNOTE-091 trial. | ||||
March 2023 | FDA full approval for the treatment of adult and pediatric patients with unresectable or metastatic MSI-H or dMMR solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. The conversion from an accelerated to a full (regular) approval is based on results from the Phase 2 KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 trials. | ||||
April 2023 | FDA accelerated approval in combination with enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, based on data from the KEYNOTE-869 trial dose escalation cohort, Cohort A and Cohort K, which was conducted in collaboration with Seagen and Astellas. |
Three Months Ended March 31, | % Change Excluding Foreign Exchange | ||||||||||||||||||||||
($ in millions) | 2023 | 2022 | % Change | ||||||||||||||||||||
Gardasil/Gardasil 9 | $ | 1,972 | $ | 1,460 | 35 | % | 43 | % | |||||||||||||||
ProQuad | 190 | 162 | 17 | % | 18 | % | |||||||||||||||||
M-M-R II | 102 | 103 | (1) | % | — | % | |||||||||||||||||
Varivax | 236 | 204 | 15 | % | 17 | % | |||||||||||||||||
RotaTeq | 297 | 216 | 38 | % | 42 | % | |||||||||||||||||
Vaxneuvance | 106 | 5 | * | * | |||||||||||||||||||
Pneumovax 23 | 96 | 173 | (44) | % | (40) | % |
Three Months Ended March 31, | % Change Excluding Foreign Exchange | ||||||||||||||||||||||
($ in millions) | 2023 | 2022 | % Change | ||||||||||||||||||||
Bridion | $ | 487 | $ | 395 | 23 | % | 27 | % | |||||||||||||||
Prevymis | 129 | 94 | 38 | % | 44 | % |
Three Months Ended March 31, | % Change Excluding Foreign Exchange | ||||||||||||||||||||||
($ in millions) | 2023 | 2022 | % Change | ||||||||||||||||||||
Alliance Revenue - Adempas/Verquvo (1) | $ | 99 | $ | 72 | 38 | % | 38 | % | |||||||||||||||
Adempas | 59 | 61 | (3) | % | 5 | % |
Three Months Ended March 31, | % Change Excluding Foreign Exchange | ||||||||||||||||||||||
($ in millions) | 2023 | 2022 | % Change | ||||||||||||||||||||
Lagevrio | $ | 392 | $ | 3,247 | (88) | % | (87) | % | |||||||||||||||
Isentress/Isentress HD | 123 | 158 | (23) | % | (20) | % |
Three Months Ended March 31, | % Change Excluding Foreign Exchange | ||||||||||||||||||||||
($ in millions) | 2023 | 2022 | % Change | ||||||||||||||||||||
Januvia/Janumet | $ | 880 | $ | 1,233 | (29) | % | (25) | % |
Three Months Ended March 31, | % Change Excluding Foreign Exchange | ||||||||||||||||||||||
($ in millions) | 2023 | 2022 | % Change | ||||||||||||||||||||
Livestock | $ | 849 | $ | 832 | 2 | % | 8 | % | |||||||||||||||
Companion Animal | 642 | 650 | (1) | % | 2 | % |
Three Months Ended March 31, | |||||||||||||||||
($ in millions) | 2023 | 2022 | % Change | ||||||||||||||
Cost of sales | $ | 3,926 | $ | 5,380 | (27) | % | |||||||||||
Selling, general and administrative | 2,479 | 2,323 | 7 | % | |||||||||||||
Research and development | 4,276 | 2,576 | 66 | % | |||||||||||||
Restructuring costs | 67 | 53 | 26 | % | |||||||||||||
Other (income) expense, net | 89 | 708 | (87) | % | |||||||||||||
$ | 10,837 | $ | 11,040 | (2) | % |
Segment Profits | |||||||||||
Three Months Ended March 31, | |||||||||||
($ in millions) | 2023 | 2022 | |||||||||
Pharmaceutical segment profits | $ | 9,140 | $ | 9,501 | |||||||
Animal Health segment profits | 566 | 585 | |||||||||
Other | (6,056) | (5,225) | |||||||||
Income Before Taxes | $ | 3,650 | $ | 4,861 |
Three Months Ended March 31, | |||||||||||
($ in millions except per share amounts) | 2023 | 2022 | |||||||||
Income before taxes as reported under GAAP | $ | 3,650 | $ | 4,861 | |||||||
Increase (decrease) for excluded items: | |||||||||||
Acquisition- and divestiture-related costs | 590 | 637 | |||||||||
Restructuring costs | 97 | 127 | |||||||||
(Income) loss from investments in equity securities, net | (429) | 684 | |||||||||
Other items: | |||||||||||
Charge for Zetia antitrust litigation settlements | 573 | — | |||||||||
Non-GAAP income before taxes | 4,481 | 6,309 | |||||||||
Taxes on income as reported under GAAP | 825 | 554 | |||||||||
Estimated tax benefit on excluded items (1) | 88 | 329 | |||||||||
Non-GAAP taxes on income | 913 | 883 | |||||||||
Non-GAAP net income | 3,568 | 5,426 | |||||||||
Less: Net income (loss) attributable to noncontrolling interests as reported under GAAP | 4 | (3) | |||||||||
Non-GAAP net income attributable to Merck & Co., Inc. | $ | 3,564 | $ | 5,429 | |||||||
EPS assuming dilution as reported under GAAP | $ | 1.11 | $ | 1.70 | |||||||
EPS difference | 0.29 | 0.44 | |||||||||
Non-GAAP EPS assuming dilution | $ | 1.40 | $ | 2.14 |
Phase 2 | ||||||||
Cancer MK-0482(2) Non-Small-Cell Lung MK-1308 (quavonlimab)(2) Non-Small-Cell Lung MK-1308A (quavonlimab+pembrolizumab) Colorectal Hepatocellular Melanoma Small-Cell Lung MK-2140 (zilovertamab vedotin) Bladder Breast Gastric Hematological Malignancies Non-Small-Cell Lung Ovarian Pancreatic MK-2870(1)(3) Neoplasm Malignant MK-3475 Keytruda Advanced Solid Tumors Prostate MK-3543 (bomedemstat) Myeloproliferative Disorders MK-4280 (favezelimab)(2) Non-Small-Cell Lung MK-4280A (favezelimab+pembrolizumab) Baldder Esophageal Melanoma 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 Bladder Cervical Endometrial Gastric Non-Small-Cell Lung MK-7339 Lynparza(1)(3) Advanced Solid Tumors MK-7684A (vibostolimab+pembrolizumab) Biliary Bladder Breast Cervical Colorectal Endometrial Esophageal Gastric Head and Neck Hematological Malignancies Hepatocellular Ovarian Prostate | Cancer MK-7902 Lenvima(1)(2) Biliary Melanoma Pancreatic Prostate Small-Cell Lung V940(1)(2) Melanoma Dengue Fever Virus Vaccine V181 HIV-1 Infection MK-8591B (islatravir+MK-8507)(4) MK-8591D (islatravir+lenacapavir)(1)(5) Hypercholesterolemia MK-0616 Nonalcoholic Steatohepatitis (NASH) MK-6024 (efinopegdutide) Pulmonary Arterial Hypertension MK-5475 Pulmonary Hypertension Due To Left Heart Disease MK-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-1026 (nemtabrutinib) Hematological Malignancies (March 2023) MK-1308A (quavonlimab+pembrolizumab) Renal Cell (April 2021) MK-3475 Keytruda Biliary (September 2019) Cutaneous Squamous Cell (August 2019) (EU) Hepatocellular (May 2016) (EU) Mesothelioma (May 2018) Ovarian (December 2018) Small-Cell Lung (May 2017) MK-3475 (pembrolizumab subcutaneous) Non-Small-Cell Lung (August 2021) MK-3475A (pembrolizumab+hyaluronidase subcutaneous) Non-Small-Cell Lung (February 2023) 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)(2) Non-Small-Cell Lung (June 2019) Small-Cell Lung (December 2020) MK-7684A (vibostolimab+pembrolizumab) Melanoma (January 2023) Non-Small-Cell Lung (April 2021) Small-Cell Lung (March 2022) MK-7902 Lenvima(1)(2) Esophageal (July 2021) Gastric (December 2020) Head and Neck (February 2020) Non-Small-Cell Lung (March 2019) HIV-1 Infection MK-8591A (doravirine+islatravir) (February 2020)(5) Pneumococcal Vaccine Adult V116 (July 2022) Pulmonary Arterial Hypertension MK-7962 (sotatercept) (January 2021) Respiratory Syncytial Virus MK-1654 (clesrovimab) (November 2021) | New Molecular Entities Antiviral COVID-19 MK-4482 Lagevrio (EU)(1)(8) Cough MK-7264 (gefapixant) (U.S.)(9) (EU) | Certain Supplemental Filings Cancer MK-3475 Keytruda • Second-Line Hepatocellular Carcinoma (KEYNOTE-394) (U.S.) • Locally Advanced or Metastatic Merkel Cell Carcinoma (KEYNOTE-913) (U.S.) • First-Line HER2 Negative Locally Advanced Unresectable or Metastatic Gastric Cancer (KEYNOTE-859) (U.S.) (EU) • Resectable Stage II, IIIA or IIIB NSCLC (KEYNOTE-671) (U.S.) (EU) • Adjuvant Non-Small-Cell Lung Cancer (KEYNOTE-091) (EU) • Relapsed or Refractory Primary Mediastinal B-Cell Lymphoma (KEYNOTE-170/KEYNOTE-A33) (JPN) MK-7339 Lynparza(1) • First-Line Metastatic Prostate Cancer (PROpel) (U.S.) (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) On FDA partial clinical hold for higher doses than those used in current clinical trials. (6) Phase 2b development costs are being co-funded. (7) Available in the U.S. under Emergency Use Authorization. (8) Requested re-examination of EU MAA following CHMP recommendation for the refusal of the marketing authorization. (9) In response to the CRL received from the FDA for this application in January 2022, Merck is performing additional analyses and anticipates submitting this information to the FDA in the second quarter of 2023. |
($ in millions) | March 31, 2023 | December 31, 2022 | |||||||||
Cash and investments | $ | 11,677 | $ | 14,207 | |||||||
Working capital | 10,271 | 11,483 | |||||||||
Total debt to total liabilities and equity | 28.5 | % | 28.1 | % |
($ in millions) | |||||||||||||||||||||||
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) | |||||||||||||||||||
January 1 - January 31 | — | — | — | $5,047 | |||||||||||||||||||
February 1 - February 28 | 328,800 | $108.43 | 328,800 | $5,012 | |||||||||||||||||||
March 1 - March 31 | 1,066,937 | $106.55 | 1,066,937 | $4,898 | |||||||||||||||||||
Total | 1,395,737 | $107.00 | 1,395,737 |
Number | Description | |||||||
3.1 | — | |||||||
3.2 | — | |||||||
31.1 | — | |||||||
31.2 | — | |||||||
32.1 | — | |||||||
32.2 | — | |||||||
101.INS | — | XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document. | ||||||
101.SCH | — | XBRL Taxonomy Extension Schema Document. | ||||||
101.CAL | — | XBRL Taxonomy Extension Calculation Linkbase Document. | ||||||
101.DEF | — | XBRL Taxonomy Extension Definition Linkbase Document. | ||||||
101.LAB | — | XBRL Taxonomy Extension Label Linkbase Document. | ||||||
101.PRE | — | XBRL Taxonomy Extension Presentation Linkbase Document. | ||||||
104 | — | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
MERCK & CO., INC. | ||||||||
Date: May 5, 2023 | /s/ Jennifer Zachary | |||||||
JENNIFER ZACHARY | ||||||||
Executive Vice President and General Counsel | ||||||||
Date: May 5, 2023 | /s/ Rita A. Karachun | |||||||
RITA A. KARACHUN | ||||||||
Senior Vice President Finance - Global Controller |
By: | /s/ Robert M. Davis | ||||
ROBERT M. DAVIS Chairman, Chief Executive Officer and President |
By: | /s/ Caroline Litchfield | ||||
CAROLINE LITCHFIELD Executive Vice President, Chief Financial Officer |
Date: May 5, 2023 | /s/ Robert M. Davis | |||||||
Name: Title: | ROBERT M. DAVIS Chairman, Chief Executive Officer and President |
Dated: May 5, 2023 | /s/ Caroline Litchfield | |||||||
Name: Title: | CAROLINE LITCHFIELD Executive Vice President, Chief Financial Officer |
CONDENSED CONSOLIDATED STATEMENT OF INCOME - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Income Statement [Abstract] | ||
Sales | $ 14,487 | $ 15,901 |
Costs, Expenses and Other | ||
Cost of sales | 3,926 | 5,380 |
Selling, general and administrative | 2,479 | 2,323 |
Research and development | 4,276 | 2,576 |
Restructuring costs | 67 | 53 |
Other (income) expense, net | 89 | 708 |
Total Costs, Expenses and Other | 10,837 | 11,040 |
Income Before Taxes | 3,650 | 4,861 |
Taxes on Income | 825 | 554 |
Net Income | 2,825 | 4,307 |
Less: Net Income (Loss) Attributable to Noncontrolling Interests | 4 | (3) |
Net Income Attributable to Merck & Co., Inc. | $ 2,821 | $ 4,310 |
Basic Earnings Per Common Share Attributable to Merck & Co., Inc. Common Shareholders (in dollars per share) | $ 1.11 | $ 1.70 |
Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders (in dollars per share) | $ 1.11 | $ 1.70 |
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Statement of Comprehensive Income [Abstract] | ||
Net Income Attributable to Merck & Co., Inc. | $ 2,821 | $ 4,310 |
Other Comprehensive (Loss) Income Net of Taxes: | ||
Net unrealized (loss) gain on derivatives, net of reclassifications | (133) | 63 |
Benefit plan net (loss) gain and prior service (cost) credit, net of amortization | (50) | 32 |
Cumulative translation adjustment | 68 | (35) |
Other comprehensive income (loss), net of taxes | (115) | 60 |
Comprehensive Income Attributable to Merck & Co., Inc. | $ 2,706 | $ 4,370 |
CONDENSED CONSOLIDATED BALANCE SHEET (Parenthetical) - USD ($) $ in Millions |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 76 | $ 72 |
Inventories classified in Other assets | 3,284 | 2,938 |
Accumulated depreciation | $ 18,256 | $ 17,985 |
Common stock, par value (in dollars per share) | $ 0.50 | $ 0.50 |
Common stock, authorized (shares) | 6,500,000,000 | 6,500,000,000 |
Common stock, issued (in shares) | 3,577,103,522 | 3,577,103,522 |
Treasury stock (in shares) | 1,039,651,210 | 1,039,269,638 |
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (Parenthetical) - USD ($) $ in Millions |
Mar. 31, 2023 |
Dec. 31, 2022 |
Mar. 31, 2022 |
Dec. 31, 2021 |
---|---|---|---|---|
Statement of Cash Flows [Abstract] | ||||
Restricted cash | $ 79 | $ 79 | $ 58 | $ 71 |
Basis of Presentation |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | 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 24, 2023. 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. Certain reclassifications have been made to prior year amounts to conform to the current year presentation. Recently Adopted Accounting Standard 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 Company adopted the guidance effective January 1, 2023. The adoption of this guidance did 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. Recently Issued Accounting Standard Not Yet Adopted 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 does not expect there to be an impact to its consolidated financial statements upon adoption
|
Spin-Off of Organon & Co. |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Spin-Off of Organon & Co. | 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, 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 is providing Organon various services and, similarly, Organon is providing Merck various services. The provision of services under the TSA generally will terminate within 25 months following the spin-off; however, the provision of certain services has been extended to 35 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 is 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 is 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 is (a) manufacturing and supplying certain active pharmaceutical ingredients for Organon, (b) manufacturing and supplying certain formulated pharmaceutical products for Organon, and (c) packaging and labeling certain finished pharmaceutical products for Organon. Similarly, Organon and Merck entered into a number of MSAs pursuant to which Organon is (a) manufacturing and supplying certain formulated pharmaceutical products for Merck, and (b) packaging and labeling 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 $94 million and $99 million and related cost of sales of $107 million and $105 million for the first quarter of 2023 and 2022, respectively. Amounts included in the condensed consolidated statement of income for the TSAs were immaterial for both the first quarter of 2023 and 2022. The amounts due from Organon under all of the above agreements were $473 million and $511 million at March 31, 2023 and December 31, 2022, respectively, and are reflected in Other current assets. The amounts due to Organon under these agreements were $229 million and $345 million at March 31, 2023 and December 31, 2022, respectively, and are included in Accrued and other current liabilities.
|
Acquisitions, Research Collaborations and License Agreements |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
Business Combination and Asset Acquisition [Abstract] | |
Acquisitions, Research Collaborations and License Agreements | Acquisitions, Research Collaborations and Licensing 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. In April 2023, Merck announced an agreement to acquire Prometheus Biosciences, Inc. (Prometheus), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. Prometheus’ lead candidate, PRA023, is a humanized monoclonal antibody directed to tumor necrosis factor-like ligand 1A, a target associated with both intestinal inflammation and fibrosis. Prometheus is developing PRA023 for the treatment of immune-mediated diseases including ulcerative colitis, Crohn’s disease, and other autoimmune conditions. Under the terms of the acquisition agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Prometheus for $200 per share in cash for a total equity value of approximately $10.8 billion. The acquisition is subject to Prometheus shareholder approval. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the third quarter of 2023. If the proposed transaction closes, the Company anticipates it will be accounted for as an asset acquisition, which would result in a charge of approximately $10.3 billion in Research and development expenses. In February 2023, Merck and Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd.) closed a license and collaboration agreement expanding their relationship in which Merck gained exclusive rights for the research, development, manufacture and commercialization of up to seven investigational preclinical antibody drug conjugates (ADCs) for the treatment of cancer. Kelun-Biotech retained the right to research, develop, manufacture and commercialize certain licensed and option ADCs for Chinese mainland, Hong Kong and Macau. Merck made an upfront payment of $175 million, which was recorded in Research and development expenses in the first quarter of 2023. In addition, Kelun-Biotech is eligible to receive future contingent development-related payments aggregating up to $1.0 billion, $2.8 billion in regulatory milestones, and $5.5 billion in sales-based milestones if Kelun-Biotech does not retain Chinese mainland, Hong Kong and Macau rights for the option ADCs and all candidates achieve regulatory approval. In addition, Kelun-Biotech is eligible to receive tiered royalties ranging from a mid-single-digit rate to a low-double-digit rate on future net sales for any commercialized ADC product. Also, in connection with the agreement, Merck invested $100 million in Kelun-Biotech’s Series B preferred shares in January 2023. In January 2023, Merck acquired Imago BioSciences, Inc. (Imago), a clinical stage biopharmaceutical company developing new medicines for the treatment of myeloproliferative neoplasms and other bone marrow diseases, for $1.35 billion (including payments to settle share-based equity awards) and also incurred approximately $60 million of transaction costs. Imago’s lead candidate bomedemstat, MK-3543 (formerly IMG-7289), is an investigational orally available lysine-specific demethylase 1 inhibitor currently being evaluated in multiple Phase 2 clinical trials for the treatment of essential thrombocythemia, myelofibrosis, and polycythemia vera, in addition to other indications. The transaction was accounted for as an acquisition of an asset since bomedemstat represented substantially all of the fair value of the gross assets acquired (excluding cash and deferred income taxes). Merck recorded net assets of $219 million, as well as Research and development expenses of $1.2 billion in the first quarter of 2023 related to the transaction. There are no future contingent payments associated with the acquisition.
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Collaborative Arrangements |
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Collaborative Arrangements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements | 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. 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 (pembrolizumab) 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 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 (which remained accrued at March 31, 2023) 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. Also in the first quarter of 2022, Merck made a sales-based milestone payment to AstraZeneca (which had been previously accrued for) of $400 million. Potential future sales-based milestone payments of $2.1 billion have not yet been accrued as they are not deemed by the Company to be probable at this time. In the first quarter of 2023, Merck made a regulatory milestone payment to AstraZeneca (which had been previously accrued for) of $105 million. In 2022, Lynparza received regulatory approvals triggering capitalized milestone payments of $250 million from Merck to AstraZeneca. Potential future regulatory milestone payments of $1.1 billion remain under the agreement. The intangible asset balance related to Lynparza (which includes capitalized sales-based and regulatory milestone payments) was $1.5 billion at March 31, 2023 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. Summarized financial information related to this collaboration is as follows:
(1) Represents amortization of capitalized milestone payments. Amount in the first quarter 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 option rights. In addition, the agreement provides for contingent payments from Merck to Eisai related to the successful achievement of sales-based and regulatory milestones. In the first quarter of 2023, Merck determined it was probable that sales of Lenvima in the future would trigger a $125 million sales-based milestone payment from Merck to Eisai. Accordingly, Merck recorded a $125 million liability and a corresponding increase to the intangible asset related to Lenvima. Merck also recognized $72 million of cumulative amortization catch-up expense related to the recognition of this milestone. In 2022, Merck made sales-based milestone payments to Eisai (which had been previously accrued for) aggregating $600 million (of which $300 million was paid in the first quarter of 2022). Potential future sales-based milestone payments of $2.4 billion have not yet been accrued as they are not deemed by the Company to be probable at this time. In 2022, Lenvima received regulatory approvals triggering capitalized milestone payments of $50 million from Merck to Eisai (of which $25 million was paid in the first quarter of 2022). There are no regulatory milestone payments remaining under the agreement. The intangible asset balance related to Lenvima (which includes capitalized sales-based and regulatory milestone payments) was $812 million at March 31, 2023 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. Summarized financial information related to this collaboration is as follows:
(1) Represents amortization of capitalized milestone payments. Amount in the first quarter of 2023 includes $72 million of cumulative amortization catch-up expense as noted above. (2) Represents an accrued milestone payment. 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., the European Union (EU) and Japan in 2021, and has since been approved in several other markets. 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 provided for contingent payments from Merck to Bayer related to the successful achievement of sales-based milestones. In the first quarter of 2022, Merck made the final $400 million sales-based milestone payment under this collaboration to Bayer. The intangible asset balances related to Adempas (which includes the acquired intangible asset balance, as well as capitalized sales-based milestone payments attributed to Adempas) and Verquvo (which reflects the portion of the final sales-based milestone payment that was attributed to Verquvo) were $613 million and $56 million, respectively, at March 31, 2023 and are included in Other Intangibles, Net. The assets are being amortized over their estimated useful lives (through 2027 for Adempas and through 2031 for Verquvo) as supported by projected future cash flows, subject to impairment testing. Summarized financial information related to this collaboration is as follows:
(1) Includes amortization of intangible assets. 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 investigational orally available antiviral candidate for the treatment of patients with COVID-19. Merck gained exclusive worldwide rights to develop and commercialize Lagevrio and related molecules. Following initial authorizations in certain markets in the fourth quarter of 2021, Lagevrio has since received multiple additional authorizations worldwide. 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. Summarized financial information related to this collaboration is as follows:
(1) Includes royalty expense and amortization of capitalized milestone payments. (2) Expenses include an allocation for overhead charges. (3) Includes accrued royalties. Amount at December 31, 2022 also includes an accrued milestone payment. Bristol Myers Squibb Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation recombinant fusion protein that is being commercialized through a global collaboration with Bristol Myers Squibb (BMS). Reblozyl is approved in the U.S., Europe and certain other markets 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 related to this collaboration within Sales of $43 million in the first quarter of 2023 (consisting of royalties) compared with $52 million in the first quarter of 2022 (consisting of royalties of $32 million and the receipt of a regulatory approval milestone payment of $20 million).
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Restructuring |
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Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Restructuring | Restructuring In 2019, Merck approved a global restructuring program (Restructuring Program) as part of a worldwide initiative focused on optimizing the Company’s manufacturing and supply network, as well as reducing its global real estate footprint. The actions 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 $3.7 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 $97 million and $127 million in the first quarter of 2023 and 2022, respectively, related to restructuring program activities. Since inception of the Restructuring Program through March 31, 2023, Merck has recorded total pretax accumulated costs of approximately $3.4 billion. For the full year of 2023, the Company expects to record charges of approximately $400 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:
Separation costs are associated with actual headcount reductions, as well as involuntary 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 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 2023 and 2022 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 10) and share-based compensation. The following table summarizes the charges and spending relating to restructuring program activities for the three months ended March 31, 2023:
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Financial Instruments |
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Derivative Instruments and Hedging Activities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Financial Instruments | Financial Instruments Derivative Instruments and Hedging Activities The Company manages the impact of foreign exchange rate movements and interest rate movements on its earnings, cash flows and fair values of assets and liabilities through operational means and through the use of various financial instruments, including derivative instruments. A significant portion of the 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), 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 Accumulated 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-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. 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 Company also uses a balance sheet risk management program to mitigate the exposure of such assets and liabilities from the effects of volatility in foreign exchange. Merck principally utilizes forward exchange contracts to offset the effects of exchange in developed country currencies, primarily the euro, Japanese yen, British pound, Canadian dollar, Australian dollar and Swiss franc. For exposures in developing country currencies, including the Chinese renminbi, the Company will enter into forward contracts to 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 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 six months. The cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows. 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. The effects of the Company’s net investment hedges on OCI and the Consolidated Statement of Income are shown below:
(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 at risk. In March 2023, the Company entered into five forward starting swaps and in April 2023 entered into two additional forward starting swaps, each with a notional amount of $100 million. 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:
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 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:
The table below provides information regarding the location and amount of pretax gains and losses of derivatives designated in fair value or cash flow hedging relationships:
(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:
(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. (2) These derivative contracts serve as economic hedges of forecasted transactions. At March 31, 2023, the Company estimates $71 million of pretax net unrealized losses on derivatives maturing within the next 12 months that hedge foreign currency denominated sales over that same period will be reclassified from 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. Investments in Debt and Equity Securities Information on investments in debt and equity securities is as follows:
(1) Unrealized net gains of $338 million were recorded in Other (income) expense, net in the first quarter of 2023 on equity securities still held at March 31, 2023. Unrealized net losses of $225 million were recorded in Other (income) expense, net in the first quarter of 2022 on equity securities still held at March 31, 2022. At March 31, 2023 and March 31, 2022, the Company also had $942 million and $643 million, respectively, of equity investments without readily determinable fair values included in Other Assets. The Company records unrealized gains on these equity investments based on favorable observable price changes from transactions involving similar investments of the same investee and records unrealized losses based on unfavorable observable price changes, which are included in Other (income) expense, net. During the first quarter of 2023, the Company recorded unrealized gains of $1 million and unrealized losses of $21 million related to certain of these equity investments still held at March 31, 2023. During the first quarter of 2022, the Company recorded unrealized gains of $14 million related to certain of these investments still held at March 31, 2022. Cumulative unrealized gains and cumulative unrealized losses based on observable price changes for investments in equity investments without readily determinable fair values still held at March 31, 2023 were $287 million and $40 million, respectively. At March 31, 2023 and March 31, 2022, the Company also had $725 million and $1.2 billion, respectively, recorded in Other Assets for equity securities held through ownership interests in investment funds. (Gains) losses recorded in Other (income) expense, net relating to these investment funds were $(132) million and $509 million for the first quarter of 2023 and 2022, 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. 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:
(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 March 31, 2023 and December 31, 2022, Cash and cash equivalents included $8.8 billion and $11.3 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 combinations is as follows:
(1) Recorded in Cost of sales, Research and development expenses, and Other (income) expense, net. Includes cumulative translation adjustments. (2) At March 31, 2023, $263 million of the liabilities relate to the termination of the Sanofi Pasteur MSD joint venture in 2016. 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 to present value the cash flows. Balance at March 31, 2023 includes $127 million recorded as a current liability for amounts expected to be paid within the next 12 months. The payments of contingent consideration in both periods relate to the Sanofi Pasteur MSD liabilities described above. 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 March 31, 2023, was $28.2 billion compared with a carrying value of $30.7 billion and at December 31, 2022, was $26.7 billion compared with a carrying value of $30.7 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. 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 billion and $2.5 billion of accounts receivable as of March 31, 2023 and December 31, 2022, 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 March 31, 2023 and December 31, 2022, the Company had collected $31 million and $67 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 April 2023 and January 2023, respectively. The net cash flows related 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 $13 million and $66 million at March 31, 2023 and December 31, 2022, respectively. The obligation to return such collateral is recorded in Accrued and other current liabilities. Cash collateral advanced by the Company to various counterparties was $19 million at December 31, 2022.
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Inventories | Inventories Inventories consisted of:
Amounts recognized as Other Assets are comprised almost entirely of raw materials and work in process inventories. At March 31, 2023 and December 31, 2022, these amounts included $2.7 billion and $2.4 billion, respectively, of inventories not expected to be sold within one year. In addition, these amounts included $590 million and $516 million at March 31, 2023 and December 31, 2022, respectively, of inventories produced in preparation for product launches.
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Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies | 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 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 March 31, 2023, approximately 95 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 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, Merck Sharp & Dohme, LLC. (MSD), Schering Corporation, Schering-Plough Corporation, and MSP Singapore Company LLC (collectively, the Merck Defendants) are defendants in a number of lawsuits filed in 2018 on behalf of direct and indirect purchasers of Zetia alleging violations of federal and state antitrust laws, as well as other state statutory and common law causes of action. The cases were consolidated in a federal multidistrict litigation (the Zetia MDL) before Judge Rebecca Beach Smith in the Eastern District of Virginia. 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. 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. In April 2022, the district court denied the direct purchaser plaintiffs’ renewed motion for class certification. In August 2021, the district court granted certification of a class of indirect purchasers. In 2020 and 2021, 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 Eastern District of Virginia against the Merck Defendants and others, making similar allegations as those made in the Zetia MDL, as well as additional allegations about Vytorin. These cases have been transferred to the Eastern District of Virginia to proceed with the Zetia MDL and remain pending. In February 2022, the Insurer Plaintiffs filed amended complaints. In March 2022, the Merck Defendants, jointly 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 cases 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 February 10, 2023, the district court denied the Merck Defendants’ and Glenmark Defendants’ motions for summary judgment. In April 2023, the Merck Defendants reached settlements with the direct purchaser and retailer plaintiffs and a proposed settlement, subject to court approval, with the indirect purchaser class. Under these agreements, Merck will pay $572.5 million to resolve the direct purchaser, retailer, and indirect purchaser plaintiffs’ claims, which was recorded as an expense in the Company’s first quarter 2023 financial results. RotaTeq Antitrust Litigation On March 3, 2023, the Mayor and City Council of Baltimore filed a putative class action against MSD in the Eastern District of Pennsylvania on behalf of all third-party payors in 35 states that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of RotaTeq (Rotavirus Vaccine, Live Oral, Pentavalent), other than for resale, from March 3, 2019 to the present. Plaintiff alleges that MSD violated federal and state antitrust laws and state consumer protection laws. Plaintiff alleges that MSD has implemented an anticompetitive vaccine bundling scheme whereby MSD leverages its alleged monopoly power in certain pediatric vaccine markets to maintain its alleged monopoly power in the U.S. market for rotavirus vaccines in order to charge supracompetitive prices for RotaTeq. Plaintiff seeks permanent injunctive relief and unspecified monetary damages on purchases of RotaTeq, trebled, and fees and costs. Bravecto Litigation As previously disclosed, in January 2020, the Company was served with a complaint in the U.S. District Court for the District of New Jersey. Following motion practice, the plaintiffs filed a second amended complaint on July 1, 2021, seeking to certify a nationwide class action of purchasers or users of Bravecto (fluralaner) products in the U.S. or its territories between May 1, 2014 and July 1, 2021. Plaintiffs contend Bravecto causes neurological events in dogs and cats and alleges violations of the New Jersey Consumer Fraud Act, Breach of Warranty, Product Liability, and related theories. The Company moved to dismiss or, alternatively, to strike the class allegations from the second amended complaint, and that motion is pending. A similar case was filed in Quebec, Canada in May 2019. The Superior Court certified a class of dog owners in Quebec who gave Bravecto Chew to their dogs between February 16, 2017 and November 2, 2018 whose dogs experienced one of the conditions in the post-marketing adverse reactions section of the labeling approved on November 2, 2018. The Company and plaintiffs each appealed the class certification decision. The Court of Appeal of Quebec heard the appeal in February 2022 and issued a decision in April 2022 allowing both parties’ appeals in part. The Court of Appeal amended the class period to start on July 2, 2014, allowed a second plaintiff to serve as a class representative, and modified the list of conditions in the class definition by adding “death” and removing “lack of efficacy.” The Court of Appeal also added to the list of questions to be considered by the trial court the questions of whether the Consumer Protection Act of Quebec applies to the sale of a veterinary product and, if so, whether it was breached. The Company sought leave to appeal to the Supreme Court of Canada, which was denied. The case is proceeding in the Superior Court. 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 — As 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. 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. The U.S. District Court for the District of New Jersey held a one-day trial on December 19, 2022 on this remaining patent term extension calculation defense. The court ordered post-trial briefing on this defense and held closing arguments on February 3, 2023. The Company has settled with five 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 granted pediatric exclusivity with respect to Januvia (sitagliptin), Janumet (sitagliptin/metformin HCI), and Janumet 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 extended exclusivity on these products to January 2023. 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). 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 in April 2022. In September 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) appealed to the U.S. Court of Appeals for the Federal Circuit. The parties have now settled the matter, and Mylan has agreed to voluntarily dismiss the appeal following entry of an amended final judgment by the district court. Additionally, in 2019, Mylan filed a petition for inter partes review (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 appealed the USPTO’s decision to the U.S. Court of Appeals for the Federal Circuit, and a hearing was held in August 2022. In September 2022, the U.S. Court of Appeals for the Federal Circuit ruled in the Company’s favor, upholding the USPTO’s decision. Mylan submitted a combined petition for panel rehearing and rehearing en banc, for which the Company was invited by the court to provide a response. On February 3, 2023, the court issued a per curiam decision denying both rehearing requests. In total, the Company has settled with 25 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. In March 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 NDA seeking approval of its sitagliptin tablets. In December 2022, the parties reached settlement that included dismissal of the case without prejudice enabling Zydus to seek final approval of a non-automatically substitutable product containing a different form of sitagliptin than that used in Januvia. In January 2023, the Company received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Zydus has filed a NDA seeking approval of sitagliptin/metformin HCl tablets and certifying that no valid or enforceable claim of any of the patents listed in FDA’s Orange Book for Janumet will be infringed by the proposed Zydus product. In March 2023, the parties reached settlement enabling Zydus to seek final approval of a non-automatically substitutable product containing a different form of sitagliptin than that used in Janumet. As a result of these favorable court rulings and settlement agreements related to the later expiring patent directed to the specific sitagliptin salt form of the products, the Company expects that Januvia and Janumet will not lose market exclusivity in the U.S. until May 2026 and Janumet XR will not lose market exclusivity in the U.S. until July 2026, although another non-automatically substitutable form of sitagliptin is likely to be available prior to 2026. Supplementary Protection Certificates (SPCs) for Janumet expired between April 7 and 10, 2023, for the majority of European countries. Prior to expiration, generic companies sought revocation of the Janumet SPCs in a number of European countries. In February 2022, a Finnish court referred certain questions to the Court of Justice of the European Union (CJEU) that could determine the validity of the Janumet SPCs in Europe, for which an oral hearing was held on March 8, 2023, and an Advocate General Opinion is expected on July 13, 2023. If the CJEU renders a decision that negatively impacts the validity of the Janumet SPCs throughout Europe, generic companies that were prevented from launching products during the SPC period in certain European countries may have an action for damages. Those countries include Belgium, Czech Republic, Ireland, Finland, France, Slovakia and Switzerland. If the Janumet SPCs are ultimately upheld, the Company has reserved its rights related to the pursuit of damages for those countries where a generic launched prior to expiry of the Janumet SPC. Keytruda — The Company filed a complaint against The Johns Hopkins University (JHU) on November 29, 2022, in the District Court of Maryland. This action concerns patents emerging from a joint research collaboration between Merck and JHU regarding the use of pembrolizumab, which Merck sells under the trade name Keytruda. Merck and JHU partnered to design and conduct a clinical study administering Keytruda to cancer patients having tumors that had the genetic biomarker known as microsatellite instability-high (MSI-H). After the conclusion of the study, JHU secured U.S. patents citing the joint research study. Merck alleges that JHU has breached the collaboration agreement by filing and obtaining these patents without informing or involving Merck and then licensing the patents to others. Merck therefore brought this action for breach of contract; declaratory judgment of noninfringement; and promissory estoppel. JHU answered the complaint on April 13, 2023, denying Merck’s claims, and counterclaiming for willful infringement of five issued U.S. patents, including a demand for damages. Lynparza — In December 2022, AstraZeneca Pharmaceuticals LP received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying AstraZeneca that Natco Pharma Limited (Natco) has filed an application to the FDA seeking pre-patent expiry approval to sell generic versions of Lynparza (olaparib) tablet. In February 2023, AstraZeneca and the Company filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Natco. This lawsuit, which asserts one or more patents covering olaparib, automatically stays FDA approval of the generic application until June 2025 or until an adverse court decision, if any, whichever may occur earlier. 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 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 March 31, 2023 and December 31, 2022 of approximately $225 million and $230 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.
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Equity | Equity
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Pension and Other Postretirement Benefit Plans |
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Pension and Other Postretirement Benefit Plans | 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 (credit) of such plans consisted of the following components:
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:
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 activities, curtailments 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 $21 million in the first quarter of 2023. This partial settlement triggered a remeasurement of some of the Company’s U.S. pension plans. The remeasurement, which was calculated using discount rates and asset values as of March 31, 2023, resulted in a net increase of $44 million to net pension liabilities and also resulted in a related adjustment 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 11), with the exception of certain amounts for termination benefits and curtailments which are recorded in Restructuring costs if the event giving rise to the termination benefits or curtailment is related to restructuring actions.
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Other (Income) Expense, Net |
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Other (Income) Expense, Net | Other (Income) Expense, Net Other (income) expense, net, consisted of:
(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. Other, net (as reflected in the table above) in the first quarter of 2023 includes a $572.5 million charge related to settlements with certain plaintiffs in the Zetia antitrust litigation (see Note 8). Interest paid for the three months ended March 31, 2023 and 2022 was $208 million and $211 million, respectively.
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Taxes on Income |
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Income Tax Disclosure [Abstract] | |
Taxes on Income | Taxes on IncomeThe effective income tax rates were 22.6% and 11.4% for the first quarter of 2023 and 2022, respectively. The effective income tax rate for the first quarter of 2023 reflects the unfavorable discrete impact of a charge for the acquisition of Imago for which no tax benefit was recognized, as well as higher foreign taxes, the impact of the R&D capitalization provision of the Tax Cuts and Jobs Act of 2017 on the Company’s U.S. global intangible low-taxed income inclusion, and net unrealized gains from investments in equity securities, which were taxed at the U.S. tax rate, partially offset by higher foreign tax credits. The effective income tax rate in the first quarter of 2022 includes the favorable impact of net unrealized losses from investments in equity securities, which were taxed at the U.S. tax rate. |
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Earnings Per Share | Earnings Per Share The calculations of earnings per share are as follows:
(1) Issuable primarily under share-based compensation plans. For the first quarter of 2023 and 2022, 1 million and 7 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.
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Other Comprehensive Income (Loss) |
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Comprehensive Income (Loss) | Other Comprehensive Income (Loss) Changes in each component of other comprehensive income (loss) are as follows:
(1) Primarily relates to foreign currency cash flow hedges that were reclassified from AOCL to Sales. (2) Includes net amortization of prior service cost, actuarial gains and losses, settlements and curtailments included in net periodic benefit cost (see Note 10).
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Segment Reporting |
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Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting | Segment Reporting The Company’s operations are principally managed on a product basis and include two operating segments, Pharmaceutical and Animal Health, 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. 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, animal producers, farmers and pet owners. Sales of the Company’s products were as follows:
(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 3). (2) Alliance revenue for Reblozyl represents royalties and, for 2022, also includes the receipt of a regulatory approval milestone payment (see Note 3). (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 3). (4) Other pharmaceutical primarily reflects sales of other human health pharmaceutical products, including products within the franchises not listed separately. (5) Other is primarily comprised of miscellaneous corporate revenue, including revenue hedging activities which increased sales by $99 million and $69 million for the three months ended March 31, 2023 and 2022, respectively, as well as revenue from third-party manufacturing arrangements (including sales to Organon). Other for the three months ended March 31, 2023 and 2022 also includes $51 million and $114 million, respectively, related to upfront and milestone payments received by Merck for out-licensing arrangements. 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 billion and $2.9 billion for the three months ended March 31, 2023 and 2022, respectively. Consolidated sales by geographic area where derived are as follows:
A reconciliation of segment profits to Income Before Taxes is as follows:
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 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.
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Basis of Presentation (Policies) |
3 Months Ended |
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Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of PresentationThe 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 24, 2023. 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. |
Recently Adopted Accounting Standards and Recently Issued Accounting Standards Not Yet Adopted | Recently Adopted Accounting Standard 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 Company adopted the guidance effective January 1, 2023. The adoption of this guidance did 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. Recently Issued Accounting Standard Not Yet Adopted 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 does not expect there to be an impact to its consolidated financial statements upon adoption
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Legal Costs | Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. |
Collaborative Arrangements (Tables) |
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Collaborative Arrangements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaboration Arrangements | Summarized financial information related to this collaboration is as follows:
(1) Represents amortization of capitalized milestone payments. Amount in the first quarter of 2022 includes $250 million of cumulative amortization catch-up expense as noted above. (2) Includes accrued milestone payments. Summarized financial information related to this collaboration is as follows:
(1) Represents amortization of capitalized milestone payments. Amount in the first quarter of 2023 includes $72 million of cumulative amortization catch-up expense as noted above. (2) Represents an accrued milestone payment. Summarized financial information related to this collaboration is as follows:
(1) Includes amortization of intangible assets. Summarized financial information related to this collaboration is as follows:
(1) Includes royalty expense and amortization of capitalized milestone payments. (2) Expenses include an allocation for overhead charges. (3) Includes accrued royalties. Amount at December 31, 2022 also includes an accrued milestone payment.
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Restructuring (Tables) |
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Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Charges Related to Restructuring Program Activities by Type of Cost | The following tables summarize the charges related to restructuring program activities by type of cost:
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Charges and Spending Relating to Restructuring Activities by Program | The following table summarizes the charges and spending relating to restructuring program activities for the three months ended March 31, 2023:
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Financial Instruments (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Derivative Instruments and Hedging Activities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Effect of Net Investment Hedges on OCI and the Consolidated Statement of Income | The effects of the Company’s net investment hedges on OCI and the Consolidated Statement of Income are shown below:
(1) No amounts were reclassified from AOCL into income related to the sale of a subsidiary.
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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 | 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:
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Information on Derivative Positions Subject to Master Netting Arrangements as if they were Presented on a Net Basis | The following table provides information on the Company’s derivative positions subject to these master 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:
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Location and Amount of Pretax Gains and Losses of Derivatives | The table below provides information regarding the location and amount of pretax gains and losses of derivatives designated in fair value or cash flow hedging relationships:
(1) Interest expense is a component of Other (income) expense, net.
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Income Statement Effects of Derivatives Not Designated as Hedging Instruments | The table below provides information regarding the income statement effects of derivatives not designated as hedging instruments:
(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. (2) These derivative contracts serve as economic hedges of forecasted transactions.
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Information on Investments in Debt and Equity Securities | Information on investments in debt and equity securities is as follows:
(1) Unrealized net gains of $338 million were recorded in Other (income) expense, net in the first quarter of 2023 on equity securities still held at March 31, 2023. Unrealized net losses of $225 million were recorded in Other (income) expense, net in the first quarter of 2022 on equity securities still held at March 31, 2022.
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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:
(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.
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Information About the Changes in Liabilities for Contingent Consideration | Summarized information about the changes in the fair value of liabilities for contingent consideration associated with business combinations is as follows:
(1) Recorded in Cost of sales, Research and development expenses, and Other (income) expense, net. Includes cumulative translation adjustments. (2) At March 31, 2023, $263 million of the liabilities relate to the termination of the Sanofi Pasteur MSD joint venture in 2016. 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 to present value the cash flows. Balance at March 31, 2023 includes $127 million recorded as a current liability for amounts expected to be paid within the next 12 months.
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Inventories (Tables) |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories | Inventories consisted of:
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Equity (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Equity |
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Pension and Other Postretirement Benefit Plans (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pension Plans | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Defined Benefit Plan Disclosure [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Benefit Costs | 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 (credit) of such plans consisted of the following components:
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Other Postretirement Benefit Plans | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Defined Benefit Plan Disclosure [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Benefit Costs | 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:
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Other (Income) Expense, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other (Income) Expense, Net | Other (income) expense, net, consisted of:
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Earnings Per Share (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Calculations of Earnings Per Share | The calculations of earnings per share are as follows:
(1) Issuable primarily under share-based compensation plans.
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Other Comprehensive Income (Loss) (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Changes in AOCI by Component | Changes in each component of other comprehensive income (loss) are as follows:
(1) Primarily relates to foreign currency cash flow hedges that were reclassified from AOCL to Sales. (2) Includes net amortization of prior service cost, actuarial gains and losses, settlements and curtailments included in net periodic benefit cost (see Note 10).
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Segment Reporting (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sales from Products | Sales of the Company’s products were as follows:
(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 3). (2) Alliance revenue for Reblozyl represents royalties and, for 2022, also includes the receipt of a regulatory approval milestone payment (see Note 3). (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 3). (4) Other pharmaceutical primarily reflects sales of other human health pharmaceutical products, including products within the franchises not listed separately. (5) Other is primarily comprised of miscellaneous corporate revenue, including revenue hedging activities which increased sales by $99 million and $69 million for the three months ended March 31, 2023 and 2022, respectively, as well as revenue from third-party manufacturing arrangements (including sales to Organon). Other for the three months ended March 31, 2023 and 2022 also includes $51 million and $114 million, respectively, related to upfront and milestone payments received by Merck for out-licensing arrangements.
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Consolidated Sales by Geographic Area | Consolidated sales by geographic area where derived are as follows:
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Reconciliation of Segment Profits to Income before Taxes | A reconciliation of segment profits to Income Before Taxes is as follows:
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Restructuring - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
Dec. 31, 2023 |
|
Restructuring Cost and Reserve [Line Items] | |||
Expected restructuring and related cost | $ 3,700 | ||
Estimate of cumulative pre tax costs that will result in cash outlays | 70.00% | ||
Estimate of cumulative pre tax costs that will be noncash | 30.00% | ||
Total pretax restructuring costs | $ 97 | $ 127 | |
Cumulative costs since program inception | $ 3,400 | ||
Forecast | |||
Restructuring Cost and Reserve [Line Items] | |||
Expected restructuring and related cost | $ 400 |
Restructuring - Activities by Program (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Restructuring Reserve [Roll Forward] | ||
Restructuring reserve, beginning balance | $ 513 | |
Expenses | 97 | $ 127 |
(Payments) receipts, net | (74) | |
Non-cash activity | (30) | |
Restructuring reserve, ending balance | 506 | |
Separation Costs | ||
Restructuring Reserve [Roll Forward] | ||
Restructuring reserve, beginning balance | 479 | |
Expenses | 41 | 26 |
(Payments) receipts, net | (47) | |
Non-cash activity | 0 | |
Restructuring reserve, ending balance | 473 | |
Accelerated Depreciation | ||
Restructuring Reserve [Roll Forward] | ||
Restructuring reserve, beginning balance | 0 | |
Expenses | 21 | 29 |
(Payments) receipts, net | 0 | |
Non-cash activity | (21) | |
Restructuring reserve, ending balance | 0 | |
Other | ||
Restructuring Reserve [Roll Forward] | ||
Restructuring reserve, beginning balance | 34 | |
Expenses | 35 | $ 72 |
(Payments) receipts, net | (27) | |
Non-cash activity | (9) | |
Restructuring reserve, ending balance | $ 33 |
Financial Instruments - Information on Derivative Positions Subject to Master Netting Arrangements as if they were Presented on a Net Basis (Details) - USD ($) $ in Millions |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||
Gross amounts recognized in the consolidated balance sheet, asset | $ 259 | $ 433 |
Gross amount subject to offset in master netting arrangements not offset in the condensed balance sheet, asset | (148) | (220) |
Cash collateral received, asset | (13) | (66) |
Net amounts, asset | 98 | 147 |
Gross amounts recognized in the consolidated balance sheet, liability | 284 | 409 |
Gross amount subject to offset in master netting arrangements not offset in the condensed balance sheet, liability | (148) | (220) |
Cash collateral received, liability | 0 | (19) |
Net amounts, liability | $ 136 | $ 170 |
Financial Instruments - Income Statement Effects on Derivatives Not Designated as Hedging Instruments (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Currency Swap | Other (income) expense, net | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Amount of Derivative Pretax (Gain) Loss Recognized in Income | $ 13 | $ 28 |
Foreign Exchange Future | Sales | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Amount of Derivative Pretax (Gain) Loss Recognized in Income | $ 2 | $ (2) |
Financial Instruments - Information About Changes in Liabilities for Contingent Consideration (Details) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023
USD ($)
|
Mar. 31, 2022
USD ($)
|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value, beginning balance | $ 456 | $ 777 |
Changes in estimated fair value | 14 | (84) |
Payments | (117) | (119) |
Other | 0 | (2) |
Fair value, ending balance | 353 | 572 |
Contingent consideration | 353 | $ 572 |
Current liability | 127 | |
Sanofi Pasteur | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value, ending balance | 263 | |
Contingent consideration | $ 263 | |
Contingent consideration, measurement input, discount rate | 0.115 |
Inventories - Schedule of Inventories (Details) - USD ($) $ in Millions |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Finished goods | $ 1,883 | $ 1,841 |
Raw materials and work in process | 7,348 | 7,063 |
Supplies | 266 | 238 |
Total (approximates current cost) | 9,497 | 9,142 |
Decrease to LIFO cost | (350) | (293) |
Total current and noncurrent inventories | 9,147 | 8,849 |
Recognized as: | ||
Inventories | 5,863 | 5,911 |
Other Assets | $ 3,284 | $ 2,938 |
Inventories - Narrative (Details) - USD ($) $ in Millions |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventory [Line Items] | ||
Inventories classified in Other assets | $ 3,284 | $ 2,938 |
Inventories Not Expected to be Sold Within One Year | ||
Inventory [Line Items] | ||
Inventories classified in Other assets | 2,700 | 2,400 |
Inventories Produced in Preparation for Product Launches | ||
Inventory [Line Items] | ||
Inventories classified in Other assets | $ 590 | $ 516 |
Pension and Other Postretirement Benefit Plans - Narrative (Details) $ in Millions |
3 Months Ended |
---|---|
Mar. 31, 2023
USD ($)
| |
Retirement Benefits [Abstract] | |
Partial settlement charge | $ 21 |
Increase to pension liabilities due to remeasurement | $ 44 |
Other (Income) Expense, Net - Schedule of Other (Income) Expense, Net (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Other Income and Expenses [Abstract] | ||
Interest income | $ (112) | $ (7) |
Interest expense | 242 | 243 |
Exchange losses | 61 | 39 |
Loss (income) from investments in equity securities, net | (450) | 708 |
Net periodic defined benefit plan (credit) cost other than service cost | (115) | (121) |
Other, net | 463 | (154) |
Other (income) expense, net | $ 89 | $ 708 |
Other (Income) Expense, Net - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Loss Contingencies [Line Items] | ||
Interest paid | $ 208.0 | $ 211.0 |
Zetia antitrust litigation | ||
Loss Contingencies [Line Items] | ||
Loss related to litigation settlement | $ 572.5 |
Taxes on Income (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Income Tax Disclosure [Abstract] | ||
Effective income tax rate | 22.60% | 11.40% |
Tax benefit resulting from acquisition charge | $ 0 |
Earnings Per Share - Calculations of Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Earnings Per Share [Abstract] | ||
Net income attributable to Merck & Co., Inc., basic | $ 2,821,000 | $ 4,310,000 |
Net income attributable to Merck & Co., Inc., diluted | $ 2,821,000 | $ 4,310,000 |
Average common shares outstanding (in shares) | 2,538 | 2,528 |
Common shares issuable (in shares) | 13 | 9 |
Average common shares outstanding assuming dilution (in shares) | 2,551 | 2,537 |
Basic Earnings Per Common Share Attributable to Merck & Co., Inc. Common Shareholders (in dollars per share) | $ 1.11 | $ 1.70 |
Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders (in dollars per share) | $ 1.11 | $ 1.70 |
Earnings Per Share - Narrative (Details) - shares shares in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Earnings Per Share [Abstract] | ||
Antidilutive shares (in shares) | 1 | 7 |
Segment Reporting - Narrative (Details) $ in Billions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023
USD ($)
segment
|
Mar. 31, 2022
USD ($)
|
|
Segment Reporting [Abstract] | ||
Number of operating segments | segment | 2 | |
Sales discounts | $ | $ 3.1 | $ 2.9 |
Segment Reporting - Consolidated Sales by Geographic Area (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Revenue from External Customer [Line Items] | ||
Sales | $ 14,487 | $ 15,901 |
United States | ||
Revenue from External Customer [Line Items] | ||
Sales | 6,659 | 7,339 |
Europe, Middle East and Africa | ||
Revenue from External Customer [Line Items] | ||
Sales | 3,303 | 4,359 |
China | ||
Revenue from External Customer [Line Items] | ||
Sales | 1,715 | 1,143 |
Asia Pacific (other than China and Japan) | ||
Revenue from External Customer [Line Items] | ||
Sales | 846 | 930 |
Japan | ||
Revenue from External Customer [Line Items] | ||
Sales | 758 | 989 |
Latin America | ||
Revenue from External Customer [Line Items] | ||
Sales | 661 | 607 |
Other | ||
Revenue from External Customer [Line Items] | ||
Sales | $ 545 | $ 534 |
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