Merck & Co., Inc. 10-Q

Item 1. Financial Statements MERCK & CO., INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENT OF INCOME (Unaudited, $ in millions except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Sales $ 15,962 $ 14,959 $ 45,485 $ 45,453 Costs, Expenses and Other Cost of sales 4,264 3,934 12,214 13,530 Selling, general and administrative 2,519 2,520 7,700 7,355 Research and development 3,307 4,399 20,904 9,773 Restructuring costs 126 94 344 288 Other (income) expense, net 126 429 388 1,576 10,342 11,376 41,550 32,522 Income Before Taxes 5,620 3,583 3,935 12,931 Taxes on Income 870 330 2,332 1,423 Net Income 4,750 3,253 1,603 11,508 Less: Net Income Attributable to Noncontrolling Interests 5 5 12 6 Net Income Attributable to Merck & Co., Inc. $ 4,745 $ 3,248 $ 1,591 $ 11,502 Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders $ 1.87 $ 1.28 $ 0.63 $ 4.55 Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders $ 1.86 $ 1.28 $ 0.62 $ 4.53 MERCK & CO., INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (Unaudited, $ in millions) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Net Income Attributable to Merck & Co., Inc. $ 4,745 $ 3,248 $ 1,591 $ 11,502 Other Comprehensive Loss Net of Taxes: Net unrealized gain on derivatives, net of reclassifications 159 338 171 584 Benefit plan net (loss) gain and prior service (cost) credit, net of amortization — ( 186 ) ( 75 ) 92 Cumulative translation adjustment ( 175 ) ( 568 ) ( 244 ) ( 990 ) ( 16 ) ( 416 ) ( 148 ) ( 314 ) Comprehensive Income Attributable to Merck & Co., Inc. $ 4,729 $ 2,832 $ 1,443 $ 11,188 The accompanying notes are an integral part of these condensed consolidated financial statements. - 3 - MERCK & CO., INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEET (Unaudited, $ in millions except per share amounts) September 30, 2023 December 31, 2022 Assets Current Assets Cash and cash equivalents $ 8,605 $ 12,694 Short-term investments 168 498 Accounts receivable (net of allowance for doubtful accounts of $ 85 in 2023 and $ 72 in 2022) 10,394 9,450 Inventories (excludes inventories of $ 3,151 in 2023 and $ 2,938 in 2022 classified in Other assets - see Note 7) 6,131 5,911 Other current assets 6,656 7,169 Total current assets 31,954 35,722 Investments 1,306 1,015 Property, Plant and Equipment, at cost, net of accumulated depreciation of $ 18,446 in 2023 and $ 17,985 in 2022 22,526 21,422 Goodwill 21,183 21,204 Other Intangibles, Net 19,199 20,269 Other Assets 10,559 9,528 $ 106,727 $ 109,160 Liabilities and Equity Current Liabilities Loans payable and current portion of long-term debt $ 887 $ 1,946 Trade accounts payable 3,509 4,264 Accrued and other current liabilities 14,840 14,159 Income taxes payable 1,981 1,986 Dividends payable 1,877 1,884 Total current liabilities 23,094 24,239 Long-Term Debt 33,972 28,745 Deferred Income Taxes 1,018 1,795 Other Noncurrent Liabilities 7,343 8,323 Merck & Co., Inc. Stockholders’ Equity Common stock, $ 0.50 par value Authorized - 6,500,000,000 shares Issued - 3,577,103,522 shares in 2023 and 2022 1,788 1,788 Other paid-in capital 44,358 44,379 Retained earnings 57,082 61,081 Accumulated other comprehensive loss ( 4,916 ) ( 4,768 ) 98,312 102,480 Less treasury stock, at cost: 1,041,809,729 shares in 2023 and 1,039,269,638 shares in 2022 57,066 56,489 Total Merck & Co., Inc. stockholders’ equity 41,246 45,991 Noncontrolling Interests 54 67 Total equity 41,300 46,058 $ 106,727 $ 109,160 The accompanying notes are an integral part of this condensed consolidated financial statement. - 4 - MERCK & CO., INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (Unaudited, $ in millions) Nine Months Ended September 30, 2023 2022 Cash Flows from Operating Activities Net income $ 1,603 $ 11,508 Adjustments to reconcile net income to net cash provided by operating activities: Amortization 1,582 1,623 Depreciation 1,326 1,394 Intangible asset impairment charges 13 910 (Income) loss from investments in equity securities, net ( 240 ) 1,361 Charge for the acquisition of Prometheus Biosciences, Inc. 10,217 — Charge for the acquisition of Imago BioSciences, Inc. 1,192 — Deferred income taxes ( 968 ) ( 1,261 ) Share-based compensation 478 396 Other ( 94 ) 1,169 Net changes in assets and liabilities ( 2,349 ) ( 2,435 ) Net Cash Provided by Operating Activities 12,760 14,665 Cash Flows from Investing Activities Capital expenditures ( 2,874 ) ( 3,239 ) Purchases of securities and other investments ( 704 ) ( 710 ) Proceeds from sales of securities and other investments 1,489 709 Acquisition of Prometheus Biosciences, Inc., net of cash acquired ( 10,705 ) — Acquisition of Imago BioSciences, Inc., net of cash acquired ( 1,327 ) — Other acquisitions, net of cash acquired — ( 121 ) Other ( 15 ) 149 Net Cash Used in Investing Activities ( 14,136 ) ( 3,212 ) Cash Flows from Financing Activities Proceeds from issuance of debt 5,939 — Payments on debt ( 1,752 ) ( 2,250 ) Purchases of treasury stock ( 953 ) — Dividends paid to stockholders ( 5,593 ) ( 5,262 ) Proceeds from exercise of stock options 119 119 Other ( 325 ) ( 172 ) Net Cash Used in Financing Activities ( 2,565 ) ( 7,565 ) Effect of Exchange Rate Changes on Cash, Cash Equivalents and Restricted Cash ( 163 ) ( 776 ) Net (Decrease) Increase in Cash, Cash Equivalents and Restricted Cash ( 4,104 ) 3,112 Cash, Cash Equivalents and Restricted Cash at Beginning of Year (includes restricted cash of $ 79 and $ 71 at January 1, 2023 and 2022, respectively, included in Other current assets ) 12,773 8,167 Cash, Cash Equivalents and Restricted Cash at End of Period (includes restricted cash of $ 64 and $ 134 at September 30, 2023 and 2022, respectively, included in Other current assets ) $ 8,669 $ 11,279 The accompanying notes are an integral part of this condensed consolidated financial statement. - 5 - Notes to Condensed Consolidated Financial Statements (unaudited) 1. Basis of Presentation The accompanying unaudited condensed consolidated financial statements of Merck & Co., Inc. (Merck or the Company) have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the United States (U.S.) (GAAP) for complete consolidated financial statements are not included herein. These interim statements should be read in conjunction with the audited financial statements and notes thereto included in Merck’s Form 10-K filed on February 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 Standards In October 2021, the Financial Accounting Standards Board (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. 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 Company adopted the guidance effective July 1, 2023. There was no impact to the Company’s consolidated financial statements upon adoption. Recently Issued Accounting Standard Not Yet Adopted In August 2023, the FASB issued amended guidance that requires a newly formed joint venture to recognize and initially measure its assets and liabilities at fair value upon formation. The amended guidance includes exceptions to fair value measurement that are consistent with the accounting for business combinations guidance. The amended guidance is effective prospectively for all joint ventures with a formation date on or after January 1, 2025, however existing joint ventures have the option to apply the guidance retrospectively. Early adoption is permitted for both interim and annual periods. The Company anticipates there will be no impact to its consolidated financial statements upon adoption. 2. 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; expense reimbursements or payments to the third party; milestone, royalty or profit share arrangements contingent upon the occurrence of certain future events linked to the success of the asset in development; and can also include option and continuation payments. 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. 2023 Transactions In October 2023, Merck and Daiichi Sankyo entered into a global development and commercialization agreement for three of Daiichi Sankyo’s deruxtecan (DXd) antibody drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd) (MK-1022), ifinatamab deruxtecan (I-DXd) (MK-2400) and raludotatug deruxtecan (R-DXd) (MK-5909). See Note 3 for additional information related to this collaboration. In June 2023, Merck acquired 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. Total consideration paid of $ 11.0 billion included $ 1.2 billion of costs to settle share-based equity awards (including $ 700 million to settle unvested equity awards). Prometheus’ lead candidate, MK-7240 (formerly PRA023), is a humanized monoclonal antibody directed to tumor necrosis factor-like ligand 1A, a target associated with both intestinal inflammation and fibrosis. MK-7240 is being developed for the treatment of immune-mediated diseases including ulcerative colitis, Crohn’s disease, and other autoimmune conditions. The transaction was accounted for as an acquisition of an asset since MK-7240 accounted for substantially all of the fair value of the gross assets acquired (excluding cash and deferred income taxes). Merck recorded net assets of $ 877 million, including cash of $ 368 million, investments of $ 296 million, deferred tax assets of $ 218 million and other net liabilities of $ 5 million, as well as a charge of $ 10.2 billion to Research and development expenses in the first nine months of 2023 related to the transaction. There are no future contingent payments associated with the acquisition. 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 ADCs for the treatment of cancer. - 6 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 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 nine months of 2023. In October 2023, Merck notified Kelun-Biotech it was terminating two of the seven candidates under the agreement. Kelun-Biotech remains eligible to receive future contingent payments aggregating up to $ 725 million in development-related payments, $ 1.95 billion in regulatory milestones, and $ 3.9 billion in sales-based milestones if Kelun-Biotech does not retain Chinese mainland, Hong Kong and Macau rights for the option ADCs and all remaining 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 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 a charge of $ 1.2 billion to Research and development expenses in the first nine months of 2023 related to the transaction. There are no future contingent payments associated with the acquisition. 2022 Transactions In October 2022, Merck and Royalty Pharma plc (Royalty Pharma) entered into a funding arrangement under which Royalty Pharma paid Merck $ 50 million to co-fund Merck’s development costs for a Phase 2b trial of MK-8189, an investigational oral phosphodiesterase 10A (PDE10A) inhibitor, which is being evaluated for the treatment of schizophrenia. As Royalty Pharma is sharing the risk of technical and regulatory success with Merck, the development funding was recognized by Merck as an obligation to perform contractual services. Accordingly, the payment received is being recognized by Merck as a reduction to Research and development expenses ratably over the estimated Phase 2b research period. Under the agreement, Royalty Pharma has no rights to MK-8189 and has no decision-making authority over the program. If Merck elects to advance MK-8189 into a Phase 3 study, Royalty Pharma has the option to provide additional funding of 50 % of the development costs up to $ 375 million. Royalty Pharma is eligible to receive royalties on future sales. If Royalty Pharma elects to provide the additional funding noted above, Royalty Pharma becomes eligible to receive future regulatory milestone payments contingent upon certain marketing approvals, as well as a higher royalty rate. Merck will record the milestone payments as an expense within Other (income) expense, net upon receipt of the related approvals. In September 2022, Merck exercised its option to jointly develop and commercialize V940 (mRNA-4157), an investigational individualized neoantigen therapy, pursuant to the terms of an existing collaboration and license agreement with Moderna, Inc. (Moderna), which resulted in a $ 250 million charge to Research and development expenses in the third quarter and first nine months of 2022. Merck and Moderna will collaborate on development and commercialization and will share costs and any profits equally under this worldwide collaboration. V940 (mRNA-4157) is currently being evaluated in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma in a Phase 3 clinical trial being conducted by Moderna. In August 2022, Merck and Orna Therapeutics (Orna), a biotechnology company pioneering a new investigational class of engineered circular RNA (oRNA) therapies, entered into a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology. Under the terms of the agreement, Merck made an upfront payment to Orna of $ 150 million, which was recorded in Research and development expenses in the third quarter and first nine months of 2022. In addition, Orna is eligible to receive future contingent payments aggregating up to $ 440 million in development-related payments, $ 675 million in regulatory milestones, and $ 2.4 billion in sales-based milestones associated with the progress of the multiple vaccine and therapeutic programs, as well as royalties ranging from a high-single-digit rate to a low-double-digit rate on any approved products derived from the collaboration. Merck also invested $ 100 million in Orna’s Series B preferred shares in fourth quarter of 2022. In July 2022, Merck and Orion Corporation (Orion) announced a global co-development and co-commercialization agreement for Orion’s investigational candidate ODM-208 (MK-5684) and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production. MK-5684 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer. Merck made an upfront payment to Orion of $ 290 million, which was recorded in Research and development expenses in the third quarter and first nine months of 2022. Orion is responsible for the manufacture of clinical and commercial supply of MK-5684. In addition, the contract provides both parties with an option to convert the initial co-development and co-commercialization agreement into a global exclusive license to Merck. If the option is exercised, Merck would assume full responsibility for all past development and commercialization expenses associated with the program since inception of the agreement, as well as all future development and commercialization expenses. In addition, Orion would be eligible to receive milestone payments associated with progress in the development and commercialization of MK-5684, as well as tiered double-digit royalties on sales if the product is approved. Also in July 2022, Merck and Kelun-Biotech closed a license and collaboration agreement in which Merck gained exclusive worldwide rights for the development, manufacture and commercialization of an investigational ADC (MK-1200) for the treatment of solid tumors. Under the terms of the agreement, Merck and Kelun-Biotech will collaborate on the early clinical - 7 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) development of the investigational ADC. Merck made an upfront payment of $ 35 million, which was recorded in Research and development expenses in the third quarter and first nine months of 2022. Kelun-Biotech is also eligible to receive future contingent milestone payments aggregating up to $ 82 million in developmental milestones, $ 334 million in regulatory milestones, and $ 485 million in sales-based milestones. The agreement also provides for Merck to pay tiered royalties ranging from a mid-single-digit rate to a low-double-digit rate on future net sales. In May 2022, in connection with an existing arrangement, Merck exercised its option to obtain an exclusive license outside of Chinese mainland, Hong Kong, Macau and Taiwan for the development, manufacture and commercialization of Kelun-Biotech’s trophoblast antigen 2 (TROP2)-targeting ADC programs, including its lead compound, SKB-264 (MK-2870), which is currently in Phase 2 clinical development. Under the terms of the agreement, Merck and Kelun-Biotech will collaborate on certain early clinical development plans, including evaluating the potential of MK-2870 as a monotherapy and in combination with Keytruda for advanced solid tumors. Upon option exercise, Merck made a payment of $ 30 million, which was recorded in Research and development expenses in the first nine months of 2022. Additionally, Merck agreed to make an additional payment of $ 25 million upon technology transfer, which occurred in the third quarter of 2023 and will be paid in the fourth quarter of 2023. Merck also agreed to make quarterly payments in 2022 and 2023 aggregating up to $ 111 million to fund Kelun-Biotech’s ongoing research and development activities, of which $ 95 million has been paid through September 2023. In addition, Kelun-Biotech is eligible to receive future contingent milestone payments (which include all program compounds) aggregating up to $ 90 million in developmental milestones, $ 290 million in first commercial sale milestones, and $ 780 million in sales-based milestones. The agreement also provides for Merck to pay tiered royalties ranging from a mid-single-digit rate to a low-double-digit rate on future net sales. 3. 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 PLC 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 September 30, 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 nine months of 2022. Additionally, in the first nine months of 2022, Merck made a sales-based milestone payment to AstraZeneca (which had been previously accrued for) of $ 400 million. 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 of $ 105 million (which had been previously accrued for). In the second quarter of 2023, Lynparza received a regulatory approval triggering a future milestone payment of up to $ 245 million from Merck to AstraZeneca. In 2022, Lynparza received regulatory approvals triggering capitalized milestone payments of $ 250 million from Merck to AstraZeneca (all of which were paid in the first nine months of 2022). Potential future regulatory milestone payments of $ 850 million remain under the agreement. The intangible asset balance related to Lynparza (which includes capitalized sales-based and regulatory milestone payments) was $ 1.6 billion at September 30, 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. - 8 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) Summarized financial information related to this collaboration is as follows: Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 Alliance revenue - Lynparza $ 299 $ 284 $ 884 $ 825 Alliance revenue - Koselugo 26 10 74 43 Total alliance revenue $ 325 $ 294 $ 958 $ 868 Cost of sales (1) 82 64 230 425 Selling, general and administrative 44 45 143 135 Research and development 23 28 65 79 ($ in millions) September 30, 2023 December 31, 2022 Receivables from AstraZeneca included in Other current assets $ 337 $ 303 Payables to AstraZeneca included in Accrued and other current liabilities (2) 257 123 Payables to AstraZeneca included in Other Noncurrent Liabilities (2) 600 600 (1) Represents amortization of capitalized milestone payments. Amount in the first nine months of 2022 includes $ 250 million of cumulative amortization catch-up expense as noted above. (2) Includes accrued milestone payments. Eisai Co., Ltd. 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. Similarly, in the third quarter of 2023 an additional $ 125 million sales-based milestone payment to Eisai was deemed to be probable of payment. Accordingly, Merck recorded $ 250 million of liabilities for these payments and corresponding increases to the intangible asset related to Lenvima. Merck also recognized $ 81 million and $ 154 million of cumulative amortization catch-up expense related to the recognition of these milestones in the third quarter and first nine months of 2023, respectively. The sales-based milestone payment that was accrued in the first quarter of 2023 was paid to Eisai in the second quarter of 2023. In the first nine months of 2022, Merck made sales-based milestone payments to Eisai (which had been previously accrued for) aggregating $ 600 million. Potential future sales-based milestone payments of $ 2.3 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 (all of which were paid in the first nine months 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 $ 743 million at September 30, 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. - 9 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) Summarized financial information related to this collaboration is as follows: Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 Alliance revenue - Lenvima $ 260 $ 202 $ 734 $ 660 Cost of sales (1) 137 53 320 159 Selling, general and administrative 46 42 145 115 Research and development 5 24 61 128 ($ in millions) September 30, 2023 December 31, 2022 Receivables from Eisai included in Other current assets $ 260 $ 214 Payables to Eisai included in Accrued and other current liabilities (2) 125 — (1) Represents amortization of capitalized milestone payments. Amounts in the third quarter and first nine months of 2023 include $ 81 million and $ 154 million, respectively, 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 nine months 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 $ 533 million and $ 51 million, respectively, at September 30, 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: Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 Alliance revenue - Adempas/Verquvo $ 92 $ 88 $ 259 $ 258 Net sales of Adempas recorded by Merck 65 57 189 181 Net sales of Verquvo recorded by Merck 8 6 24 15 Total sales $ 165 $ 151 $ 472 $ 454 Cost of sales (1) 53 55 165 158 Selling, general and administrative 33 42 100 107 Research and development 26 18 76 52 ($ in millions) September 30, 2023 December 31, 2022 Receivables from Bayer included in Other current assets $ 157 $ 143 Payables to Bayer included in Accrued and other current liabilities 82 80 (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 - 10 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 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: Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 Net sales of Lagevrio recorded by Merck $ 640 $ 436 $ 1,236 $ 4,859 Cost of sales (1)(2) 348 244 762 2,586 Selling, general and administrative (2) 21 48 72 117 Research and development (2) 8 18 33 74 ($ in millions) September 30, 2023 December 31, 2022 Payables to Ridgeback included in Accrued and other current liabilities (3) $ 242 $ 348 (1) Includes royalty expense, amortization of capitalized milestone payments and inventory reserves. (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 Company 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 Company (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. Alliance revenue related to this collaboration (recorded within Sales ) consists of royalties and, for the first nine months of 2022, also includes the receipt of a regulatory approval milestone payment of $ 20 million. Merck recorded alliance revenue related to this collaboration of $ 52 million and $ 142 million in the third quarter and first nine months of 2023, respectively, compared with $ 39 million and $ 124 million in the third quarter and first nine months of 2022, respectively. Daiichi Sankyo In October 2023, Merck and Daiichi Sankyo entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd ADC candidates: patritumab deruxtecan (HER3-DXd) (MK-1022), ifinatamab deruxtecan (I-DXd) (MK-2400) and raludotatug deruxtecan (R-DXd) (MK-5909). All three potentially first-in-class DXd ADCs are in various stages of clinical development for the treatment of multiple solid tumors both as monotherapy and/or in combination with other treatments. The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. Under the terms of the agreement, Merck made payments to Daiichi Sankyo totaling $ 4.0 billion. These payments included $ 1.0 billion ($ 500 million each for patritumab deruxtecan and ifinatamab deruxtecan) which may be refundable on a pro-rated basis in the event of early termination of development with respect to either program. In addition, the agreement provides for a continuation payment of $ 750 million related to patritumab deruxtecan due from Merck in October 2024 and a continuation payment of $ 750 million related to raludotatug deruxtecan due from Merck in October 2025. Merck may opt out of the collaboration for patritumab deruxtecan and/or raludotatug deruxtecan by electing not to pay the applicable continuation payment. If Merck opts out of patritumab deruxtecan and/or raludotatug deruxtecan, the non-refundable upfront payments already paid will be retained by Daiichi Sankyo and rights related to such DXd ADCs will be returned to Daiichi Sankyo. The agreement also provides for contingent payments from Merck to Daiichi Sankyo of up to an additional $ 5.5 billion for each DXd ADC upon the successful achievement of certain sales-based milestones. Following regulatory approval, Daiichi Sankyo will generally record sales worldwide (Daiichi Sankyo will be the principal on sales transactions) and the companies will equally share expenses as well as profits worldwide except for Japan where Daiichi Sankyo retains exclusive rights and Merck will receive a sales-based royalty. Merck will record its share of product sales, net of cost of sales and commercialization costs, as alliance revenue. For raludotatug deruxtecan, Merck will be responsible for 75 % of the first $ 2.0 billion of research and development expenses; the companies will share equally all other - 11 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) expenses as well as profits worldwide. Merck will include its share of development costs associated with the collaboration as part of Research and development expenses. In conjunction with this transaction, Merck will record an aggregate pretax charge of $ 5.5 billion to Research and development expenses in the fourth quarter of 2023 for the $ 4.0 billion upfront payments and the $ 1.5 billion in continuation payments. 4. 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. A majority of the services provided under the TSA terminated within 25 months following the spin-off; a majority of the remaining services will terminate within 35 months following the spin-off. 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 $ 100 million and $ 100 million and related cost of sales of $ 106 million and $ 104 million for the third quarter of 2023 and 2022, respectively, and sales of $ 290 million and $ 293 million and related cost of sales of $ 314 million and $ 312 million for the first nine months of 2023 and 2022, respectively. Amounts included in the condensed consolidated statement of income for the TSAs were immaterial for the three and nine months ended September 30, 2023 and September 30, 2022. The amounts due from Organon under all of the above agreements were $ 526 million and $ 511 million at September 30, 2023 and December 31, 2022, respectively, and are reflected in Other current assets . The amounts due to Organon under these agreements were $ 385 million and $ 345 million at September 30, 2023 and December 31, 2022, respectively, and are included in Accrued and other current liabilities . 5. 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 $ 4.0 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 $ 199 million and $ 175 million in the third quarter of 2023 and 2022, respectively, and $ 532 million and $ 559 million for the first nine months of 2023 and 2022, respectively, related to restructuring program activities. Since inception of the Restructuring Program through September 30, 2023, Merck has recorded total pretax accumulated costs of approximately $ 3.9 billion. For the full year of 2023, the Company expects to record charges of approximately $ 650 million related to the Restructuring Program. For segment reporting, restructuring charges are unallocated expenses. - 12 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) The following tables summarize the charges related to restructuring program activities by type of cost: Three Months Ended September 30, 2023 Nine Months Ended September 30, 2023 ($ in millions) Separation Costs Accelerated Depreciation Other Total Separation Costs Accelerated Depreciation Other Total Cost of sales $ — $ 31 $ 2 $ 33 $ — $ 74 $ 20 $ 94 Selling, general and administrative — 5 35 40 — 5 88 93 Research and development — — — — — — 1 1 Restructuring costs 95 — 31 126 246 — 98 344 $ 95 $ 36 $ 68 $ 199 $ 246 $ 79 $ 207 $ 532 Three Months Ended September 30, 2022 Nine Months Ended September 30, 2022 ($ in millions) Separation Costs Accelerated Depreciation Other Total Separation Costs Accelerated Depreciation Other Total Cost of sales $ — $ 16 $ 38 $ 54 $ — $ 51 $ 116 $ 167 Selling, general and administrative — 5 21 26 — 17 57 74 Research and development — — 1 1 — 29 1 30 Restructuring costs 65 — 29 94 197 — 91 288 $ 65 $ 21 $ 89 $ 175 $ 197 $ 97 $ 265 $ 559 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 12) and share-based compensation. The following table summarizes the charges and spending relating to restructuring program activities for the nine months ended September 30, 2023: ($ in millions) Separation Costs Accelerated Depreciation Other Total Restructuring reserves January 1, 2023 $ 479 $ — $ 34 $ 513 Expenses 246 79 207 532 (Payments) receipts, net ( 191 ) — ( 103 ) ( 294 ) Non-cash activity — ( 79 ) ( 105 ) ( 184 ) Restructuring reserves September 30, 2023 (1) $ 534 $ — $ 33 $ 567 (1) The remaining cash outlays are expected to be largely completed by the end of 2025. 6. Financial Instruments Derivative Instruments and Hedging Activities The Company manages the impact of foreign exchange rate movements and interest rate movements on its earnings, cash flows and fair values of assets and liabilities through operational means and through the use of various financial instruments, including derivative instruments. 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. - 13 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 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 Condensed Consolidated Statement of Operations are shown below: Amount of Pretax (Gain) Loss Recognized in Other Comprehensive Income (1) Amount of Pretax (Gain) Loss Recognized in Other (income) expense, net for Amounts Excluded from Effectiveness Testing Three Months Ended September 30, Nine Months Ended September 30, Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 2023 2022 2023 2022 Net Investment Hedging Relationships Foreign exchange contracts $ ( 1 ) $ ( 1 ) $ — $ ( 47 ) $ — $ — $ 1 $ ( 2 ) Euro-denominated notes ( 100 ) ( 250 ) ( 26 ) ( 431 ) — — — — (1) No amounts were reclassified from AOCL into income related to the sale of a subsidiary. - 14 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 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. At September 30, 2023, the Company was a party to three pay-floating, receive-fixed interest rate swap contracts designated as fair value hedges of a portion of fixed-rate notes as detailed in the table below. September 30, 2023 ($ in millions) Par Value of Debt Number of Interest Rate Swaps Held Total Swap Notional Amount 4.50 % notes due 2033 $ 1,500 3 $ 750 The interest rate swap contracts are designated hedges of the fair value changes in the notes attributable to changes in the benchmark Secured Overnight Financing Rate (SOFR) swap rate. The fair value change in the notes attributable to changes in the SOFR swap rate are recorded in interest expense along with the offsetting fair value changes in the swap contracts. In October 2023, the Company entered into an additional interest rate swap with a notional amount of $ 250 million also related to its 4.50 % notes due 2033. The cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows. The table below presents the location of amounts recorded on the Condensed Consolidated Balance Sheet related to cumulative basis adjustments for fair value hedges: Carrying Amount of Hedged Liabilities Cumulative Amount of Fair Value Hedging Adjustment Increase (Decrease) Included in the Carrying Amount ($ in millions) September 30, 2023 December 31, 2022 September 30, 2023 December 31, 2022 Balance Sheet Line Item in which Hedged Item is Included Long-Term Debt $ 743 $ — $ ( 7 ) $ — Presented in the table below is the fair value of derivatives on a gross basis segregated between those derivatives that are designated as hedging instruments and those that are not designated as hedging instruments: September 30, 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 Other Noncurrent Liabilities $ — $ 8 $ 750 $ — $ — $ — Foreign exchange contracts Other current assets 321 — 8,059 220 — 4,824 Foreign exchange contracts Other Assets 51 — 1,746 27 — 1,609 Foreign exchange contracts Accrued and other current liabilities — 4 680 — 101 2,691 Foreign exchange contracts Other Noncurrent Liabilities — 1 178 — 1 91 $ 372 $ 13 $ 11,413 $ 247 $ 102 $ 9,215 Derivatives Not Designated as Hedging Instruments Balance Sheet Caption Foreign exchange contracts Other current assets $ 229 $ — $ 8,485 $ 186 $ — $ 8,540 Foreign exchange contracts Accrued and other current liabilities — 163 9,910 — 307 10,926 $ 229 $ 163 $ 18,395 $ 186 $ 307 $ 19,466 $ 601 $ 176 $ 29,808 $ 433 $ 409 $ 28,681 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: September 30, 2023 December 31, 2022 ($ in millions) Asset Liability Asset Liability Gross amounts recognized in the condensed consolidated balance sheet $ 601 $ 176 $ 433 $ 409 Gross amounts subject to offset in master netting arrangements not offset in the condensed consolidated balance sheet ( 138 ) ( 138 ) ( 220 ) ( 220 ) Cash collateral received/posted ( 143 ) — ( 66 ) ( 19 ) Net amounts $ 320 $ 38 $ 147 $ 170 - 15 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 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: Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 2023 2022 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) Sales Other (income) expense, net (1) Other comprehensive income (loss) $ 15,962 $ 14,959 $ 126 $ 429 $ ( 16 ) $ ( 416 ) $ 45,485 $ 45,453 $ 388 $ 1,576 $ ( 148 ) $ ( 314 ) (Gain) loss on fair value hedging relationships: Interest rate swap contracts Hedged items — — ( 7 ) 1 — — — — ( 7 ) ( 13 ) — — Derivatives designated as hedging instruments — — 8 — — — — — 8 4 — — Impact of cash flow hedging relationships: Foreign exchange contracts Amount of gain recognized in OCI on derivatives — — — — 247 682 — — — — 375 1,233 Increase in Sales as a result of AOCL reclassifications 45 253 — — ( 45 ) ( 253 ) 170 491 — — ( 170 ) ( 491 ) Interest rate contracts Amount of gain recognized in Other (income) expense, net on derivatives — — — ( 1 ) — — — — ( 1 ) ( 2 ) — — Amount of (loss) gain recognized in OCI on derivatives — — — — — ( 1 ) — — — — 13 ( 2 ) (1) Interest expense is a component of Other (income) expense, net. The table below provides information regarding the income statement effects of derivatives not designated as hedging instruments: Amount of Derivative Pretax (Gain) Loss Recognized in Income Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 Derivatives Not Designated as Hedging Instruments Income Statement Caption Foreign exchange contracts (1) Other (income) expense, net $ 60 $ ( 41 ) $ 32 $ ( 77 ) Foreign exchange contracts (2) Sales — ( 4 ) ( 3 ) ( 42 ) (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 September 30, 2023, the Company estimates $ 269 million of pretax net unrealized gains on derivatives maturing within the next 12 months that hedge foreign currency denominated sales over that same period will be reclassified from AOCL to Sales . The amount ultimately reclassified to Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual exchange rates at maturity. - 16 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) Investments in Debt and Equity Securities Information on investments in debt and equity securities is as follows: September 30, 2023 December 31, 2022 Amortized Cost Gross Unrealized Fair Value Amortized Cost Gross Unrealized Fair Value ($ in millions) Gains Losses Gains Losses Commercial paper $ 168 $ — $ — $ 168 $ 498 $ — $ — $ 498 U.S. government and agency securities 67 — — 67 68 — — 68 Corporate notes and bonds 12 — — 12 3 — — 3 Total debt securities $ 247 $ — $ — $ 247 $ 569 $ — $ — $ 569 Publicly traded equity securities (1) 1,746 1,284 Total debt and publicly traded equity securities $ 1,993 $ 1,853 (1) Unrealized net gains of $ 61 million and $ 327 million were recorded in Other (income) expense, net in the third quarter and first nine months of 2023, respectively, on equity securities still held at September 30, 2023. Unrealized net losses of $ 221 million and $ 415 million were recorded in Other (income) expense, net in the third quarter and first nine months of 2022, respectively, on equity securities still held at September 30, 2022. At September 30, 2023 and September 30, 2022, the Company also had $ 863 million and $ 705 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 nine months of 2023 , the Company recorded unrealized gains of $ 7 million and unrealized losses of $ 24 million related to certain of these equity investments still held at September 30, 2023. During the first nine months of 2022 , the Company recorded unrealized gains of $ 21 million and unrealized losses of $ 12 million related to certain of these equity investments still held at September 30, 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 September 30, 2023 were $ 296 million and $ 40 million, respectively. At September 30, 2023 and September 30, 2022, the Company also had $ 467 million and $ 655 million, respectively, recorded in Other Assets for equity securities held through ownership interests in investment funds. Losses recorded in Other (income) expense, net relating to these investment funds were $ 93 million and $ 141 million for the third quarter of 2023 and 2022, respectively, and were $ 66 million and $ 952 million for the first nine months 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. - 17 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis Financial assets and liabilities measured at fair value on a recurring basis are summarized below: Fair Value Measurements Using Fair Value Measurements Using Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total ($ in millions) September 30, 2023 December 31, 2022 Assets Investments Commercial paper $ — $ 168 $ — $ 168 $ — $ 498 $ — $ 498 Publicly traded equity securities 1,306 — — 1,306 1,015 — — 1,015 1,306 168 — 1,474 1,015 498 — 1,513 Other assets (1) U.S. government and agency securities 67 — — 67 68 — — 68 Corporate notes and bonds 12 — — 12 3 — — 3 Publicly traded equity securities (2) 440 — — 440 269 — — 269 519 — — 519 340 — — 340 Derivative assets (3) Forward exchange contracts — 431 — 431 — 218 — 218 Purchased currency options — 170 — 170 — 215 — 215 — 601 — 601 — 433 — 433 Total assets $ 1,825 $ 769 $ — $ 2,594 $ 1,355 $ 931 $ — $ 2,286 Liabilities Other liabilities Contingent consideration $ — $ — $ 345 $ 345 $ — $ — $ 456 $ 456 Derivative liabilities (3) Forward exchange contracts — 160 — 160 — 402 — 402 Written currency options — 8 — 8 — 7 — 7 Interest rate swaps — 8 — 8 — — — — — 176 — 176 — 409 — 409 Total liabilities $ — $ 176 $ 345 $ 521 $ — $ 409 $ 456 $ 865 (1) Investments included in other assets are restricted as to use, including for the payment of benefits under employee benefit plans. (2) Balance at September 30, 2023 includes securities with a total fair value of $ 132 million, which are subject to a contractual sale restriction that expires in July 2024. (3) The fair value determination of derivatives includes the impact of the credit risk of counterparties to the derivatives and the Company’s own credit risk, the effects of which were not significant. As of September 30, 2023 and December 31, 2022, Cash and cash equivalents included $ 7.8 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: ($ in millions) 2023 2022 Fair value January 1 $ 456 $ 777 Changes in estimated fair value (1) 6 ( 156 ) Payments ( 117 ) ( 119 ) Other — ( 3 ) Fair value September 30 (2) $ 345 $ 499 (1) Recorded in Cost of sales, Research and development expenses, and Other (income) expense, net . Includes cumulative translation adjustments. (2) At September 30, 2023, $ 255 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 September 30, 2023 includes $ 126 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. - 18 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) Other Fair Value Measurements Some of the Company’s financial instruments, such as cash and cash equivalents, receivables and payables, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature. The estimated fair value of loans payable and long-term debt (including current portion) at September 30, 2023, was $ 29.5 billion compared with a carrying value of $ 34.9 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, distributors 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 $ 3.5 billion and $ 2.5 billion of accounts receivable as of September 30, 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, generally within thirty days after receipt. As of September 30, 2023 and December 31, 2022, the Company had collected $ 39 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 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 $ 143 million and $ 66 million at September 30, 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. 7. Inventories Inventories consisted of: ($ in millions) September 30, 2023 December 31, 2022 Finished goods $ 1,840 $ 1,841 Raw materials and work in process 7,630 7,063 Supplies 281 238 Total 9,751 9,142 Decrease to LIFO cost ( 469 ) ( 293 ) $ 9,282 $ 8,849 Recognized as: Inventories $ 6,131 $ 5,911 Other Assets 3,151 2,938 Amounts recognized as Other Assets are comprised almost entirely of raw materials and work in process inventories. At both September 30, 2023 and December 31, 2022, these amounts included $ 2.4 billion of inventories not expected to be sold within one year. In addition, these amounts included $ 756 million and $ 516 million at September 30, 2023 and December 31, 2022, respectively, of inventories produced in preparation for product launches. - 19 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 8. Other Intangibles In the third quarter of 2022, the Company recorded $ 887 million of impairment charges within Research and development expenses related to intangible assets obtained in connection with the 2020 acquisition of ArQule, Inc. Of this amount, $ 807 million represents an in-process research and development (IPR&D) impairment charge related to nemtabrutinib (MK-1026), a novel, oral BTK inhibitor currently being evaluated for the treatment of B-cell malignancies. Following discussions with regulatory authorities in the third quarter of 2022, the development period for nemtabrutinib was extended, which constituted a triggering event that required the evaluation of the nemtabrutinib intangible asset for impairment. The Company estimated the fair value of nemtabrutinib utilizing an income approach which uses Level 3 inputs to calculate the present value of projected future cash flows. The market participant assumptions used to derive the forecasted cash flows were updated to reflect a delay in the anticipated launch date for nemtabrutinib, which resulted in lower cumulative revenue forecasts and a reduction in the estimated fair value. The revised estimated fair value of nemtabrutinib when compared with its related carrying value resulted in the IPR&D impairment charge noted above. In December 2022, regulatory authorities provided additional feedback with respect to clinical study design that led to a further reassessment of the development plan for nemtabrutinib, which was expected to result in changes to the clinical study design, and corresponding delays in the anticipated approval and launch timelines, which constituted a triggering event. Utilizing an income approach, the forecasted cash flows were updated to reflect a decline in forecasted revenue coupled with an increase in development cost forecasts, which reduced projected cash flows lowering the estimated current fair value of nemtabrutinib. The revised estimated fair value of nemtabrutinib when compared with its then-related carrying value resulted in a $ 780 million impairment charge, which was recorded in the fourth quarter of 2022. The remaining IPR&D intangible asset related to nemtabrutinib is $ 418 million. If the assumptions used to estimate the fair value of nemtabrutinib prove to be incorrect and the development of nemtabrutinib does not progress as anticipated thereby adversely affecting projected future cash flows, the Company may record an additional impairment charge in the future and such charge could be material. The remaining $ 80 million intangible asset impairment charge in the third quarter of 2022 related to derazantinib and resulted from the termination of the out-licensing agreement and the decision by Merck not to pursue development of derazantinib. 9. Long-Term Debt In May 2023, the Company issued $ 6.0 billion principal amount of senior unsecured notes consisting of $ 500 million of 4.05 % notes due 2028, $ 750 million of 4.30 % notes due 2030, $ 1.5 billion of 4.50 % notes due 2033, $ 750 million of 4.90 % notes due 2044, $ 1.5 billion of 5.00 % notes due 2053, and $ 1.0 billion of 5.15 % notes due 2063. The Company used a portion of the $ 5.9 billion net proceeds from this offering to fund a portion of the cash consideration paid for the acquisition of Prometheus, including related fees and expenses, and used the remaining net proceeds for general corporate purposes including to repay commercial paper borrowings and other indebtedness with upcoming maturities. 10. 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 As previously disclosed, 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 - 20 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) Vaccine, Recombinant). As of September 30, 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. Governmental Proceedings Inflation Reduction Act As previously disclosed, on June 6, 2023, Merck filed a complaint in the U.S. District Court for the District of Columbia against the U.S. government regarding the Inflation Reduction Act’s “Drug Price Negotiation Program” for Medicare (the Program). This litigation seeks relief from the Program by challenging its constitutionality as violative of the First and Fifth Amendments to the U.S. Constitution. Other 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) were 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. As previously disclosed, 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 agreed to 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 financial results for the first nine months of 2023. On October 18, 2023, the court granted final approval of the indirect purchaser class settlement. 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 were 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. Qui Tam Litigation As previously disclosed, in June 2012, the U.S. District Court for the Eastern District of Pennsylvania unsealed a complaint that had been filed against the Company under the federal False Claims Act by two former employees alleging, among other things, that the Company defrauded the U.S. government by falsifying data in connection with a clinical study conducted on the mumps component of the Company’s M-M-R II vaccine. The complaint alleges the fraud took place between 1999 and 2001. The U.S. government had the right to participate in and take over the prosecution of this lawsuit but notified the court that it declined to exercise that right. The two former employees are pursuing the lawsuit without the involvement of the U.S. government. In addition, as previously disclosed, two putative class action lawsuits on behalf of direct purchasers of the M-M-R II vaccine, which charge that the Company misrepresented the efficacy of the M-M-R II vaccine in violation of federal antitrust laws and various state consumer protection laws, are pending in the Eastern District of Pennsylvania. In September 2014, the court denied Merck’s motion to dismiss the False Claims Act suit and granted in part and denied in part its motion to dismiss the then-pending antitrust suit. As a result, both the False Claims Act suit and the antitrust suits proceeded into discovery, which is complete, and the parties filed and briefed cross-motions for summary judgment. On July 27, 2023, in the False Claims Act case, the court denied relators’ motion for summary judgment, granted two of the Company’s motions for summary judgment, and denied the Company’s remaining motions for summary judgment as moot. The court entered judgment in favor of the Company - 21 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) and dismissed relators’ amended complaint in full with prejudice. Relators have appealed that decision. In the antitrust case, the court granted the Company’s motion for summary judgment as to plaintiffs’ state law claims and denied the motion as to plaintiffs’ antitrust claim. On October 20, 2023, the Company petitioned the Third Circuit for permission to appeal the antitrust decision. Patent Litigation From time to time, generic manufacturers of pharmaceutical products file abbreviated New Drug Applications (NDAs) with the U.S. Food and Drug Administration (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 were consolidated. 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 stipulated to infringement of the asserted claims and withdrew all remaining claims and defenses other than a defense seeking to shorten the patent term extension (PTE) 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 PTE calculation defense and held closing arguments on February 3, 2023. While the New Jersey action was pending, the Company 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 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. On June 13, 2023, the U.S. District Court for the District of New Jersey ruled in Merck’s favor. The court held that Merck’s calculation of PTE for the sugammadex patent covering the compound is not invalid and that the U.S. Patent & Trademark Office correctly granted a full 5-year extension. This ruling affirms and validates Merck’s U.S. patent protection for Bridion through at least January 2026. On June 29, 2023, the U.S. District Court for the District of New Jersey issued a final judgment prohibiting the FDA from approving any of the pending or tentatively approved generic applications until January 27, 2026, except for any subsequent agreements between defendants and Merck or further order by the court. On July 24, 2023, defendants filed a notice of appeal with the Federal Court of Appeals. 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. The Company also filed a patent infringement lawsuit against Mylan in the U.S. District Court for the Northern District of West Virginia. 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 U.S. 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 Viatris has agreed to voluntarily dismiss the appeal following entry of an amended final judgment by the district court. In total, the Company has settled with 26 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. - 22 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 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 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 2027 salt/polymorph 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 Zydus has received FDA approval for a non-automatically substitutable form of sitagliptin that differs from the form in the Company’s sitagliptin products . Supplementary Protection Certificates (SPCs) for Janumet expired in April 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 in the fourth quarter of 2023 with a decision in the first quarter of 2024. 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 U.S. 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 nine 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 September 30, 2023 and December 31, 2022 of approximately $ 220 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. - 23 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 11. Equity Three Months Ended September 30, 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 July 1, 2022 3,577 $ 1,788 $ 44,115 $ 58,437 $ ( 4,327 ) 1,044 $ ( 56,770 ) $ 75 $ 43,318 Net income attributable to Merck & Co., Inc. — — — 3,248 — — — — 3,248 Other comprehensive loss, net of taxes — — — — ( 416 ) — — — ( 416 ) Cash dividends declared on common stock ($ 0.69 per share) — — — ( 1,757 ) — — — — ( 1,757 ) Share-based compensation plans and other — — 128 — — — 12 — 140 Net income attributable to noncontrolling interests — — — — — — — 5 5 Distributions attributable to noncontrolling interests — — — — — — — ( 14 ) ( 14 ) Balance at September 30, 2022 3,577 $ 1,788 $ 44,243 $ 59,928 $ ( 4,743 ) 1,044 $ ( 56,758 ) $ 66 $ 44,524 Balance at July 1, 2023 3,577 $ 1,788 $ 44,219 $ 54,198 $ ( 4,900 ) 1,038 $ ( 56,612 ) $ 49 $ 38,742 Net income attributable to Merck & Co., Inc. — — — 4,745 — — — — 4,745 Other comprehensive loss, net of taxes — — — — ( 16 ) — — — ( 16 ) Cash dividends declared on common stock ($ 0.73 per share) — — — ( 1,861 ) — — — — ( 1,861 ) Treasury stock shares purchased — — — — — 4 ( 466 ) — ( 466 ) Share-based compensation plans and other — — 139 — — — 12 — 151 Net income attributable to noncontrolling interests — — — — — — — 5 5 Balance at September 30, 2023 3,577 $ 1,788 $ 44,358 $ 57,082 $ ( 4,916 ) 1,042 $ ( 57,066 ) $ 54 $ 41,300 Nine Months Ended September 30, 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 3,577 $ 1,788 $ 44,238 $ 53,696 $ ( 4,429 ) 1,049 $ ( 57,109 ) $ 73 $ 38,257 Net income attributable to Merck & Co., Inc. — — — 11,502 — — — — 11,502 Other comprehensive loss, net of taxes — — — — ( 314 ) — — — ( 314 ) Cash dividends declared on common stock ($ 2.07 per share) — — — ( 5,270 ) — — — — ( 5,270 ) Share-based compensation plans and other — — 5 — — ( 5 ) 351 — 356 Net income attributable to noncontrolling interests — — — — — — — 6 6 Distributions attributable to noncontrolling interests — — — — — — — ( 13 ) ( 13 ) Balance at September 30, 2022 3,577 $ 1,788 $ 44,243 $ 59,928 $ ( 4,743 ) 1,044 $ ( 56,758 ) $ 66 $ 44,524 Balance at January 1, 2023 3,577 $ 1,788 $ 44,379 $ 61,081 $ ( 4,768 ) 1,039 $ ( 56,489 ) $ 67 $ 46,058 Net income attributable to Merck & Co., Inc. — — — 1,591 — — — — 1,591 Other comprehensive loss, net of taxes — — — — ( 148 ) — — — ( 148 ) Cash dividends declared on common stock ($ 2.19 per share) — — — ( 5,590 ) — — — — ( 5,590 ) Treasury stock shares purchased — — — — — 9 ( 953 ) — ( 953 ) Share-based compensation plans and other — — ( 21 ) — — ( 6 ) 376 — 355 Net income attributable to noncontrolling interests — — — — — — — 12 12 Distributions attributable to noncontrolling interests — — — — — — — ( 25 ) ( 25 ) Balance at September 30, 2023 3,577 $ 1,788 $ 44,358 $ 57,082 $ ( 4,916 ) 1,042 $ ( 57,066 ) $ 54 $ 41,300 - 24 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 12. 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: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 ($ in millions) U.S. International U.S. International U.S. International U.S. International Service cost $ 88 $ 48 $ 91 $ 66 $ 239 $ 148 $ 289 $ 213 Interest cost 130 76 123 35 396 225 330 110 Expected return on plan assets ( 182 ) ( 131 ) ( 182 ) ( 93 ) ( 553 ) ( 390 ) ( 576 ) ( 292 ) Amortization of unrecognized prior service (credit) cost — ( 6 ) ( 8 ) ( 3 ) ( 1 ) 5 ( 24 ) ( 10 ) Net (gain) loss amortization — ( 1 ) 10 24 — ( 2 ) 122 73 Termination benefits 1 — 1 — 2 — 2 1 Curtailments — — 3 — 5 — 11 — Settlements — — 79 — 26 — 180 — $ 37 $ ( 14 ) $ 117 $ 29 $ 114 $ ( 14 ) $ 334 $ 95 The Company provides medical benefits, principally to its eligible U.S. retirees and similar benefits to their dependents, through its other postretirement benefit plans. The net credit of such plans consisted of the following components: Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 Service cost $ 8 $ 11 $ 24 $ 36 Interest cost 16 11 47 34 Expected return on plan assets ( 16 ) ( 21 ) ( 48 ) ( 64 ) Amortization of unrecognized prior service credit ( 12 ) ( 14 ) ( 37 ) ( 42 ) Net gain amortization ( 11 ) ( 11 ) ( 31 ) ( 32 ) Curtailments — — ( 1 ) ( 1 ) $ ( 15 ) $ ( 24 ) $ ( 46 ) $ ( 69 ) In connection with restructuring actions (see Note 5), termination charges were recorded on pension plans related to expanded eligibility for certain employees e x iting 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 partial settlement charges in the third quarter and first nine months of both 2023 and 2022. These partial settlements triggered remeasurements of some of the Company’s U.S. pension plans. The third quarter 2023 remeasurement, which was calculated using discount rates and asset values as of September 30, 2023, resulted in a net decrease of $ 34 million to net pension liabilities and a related adjustment to AOCL . Remeasurements during the first nine months of 2023 resulted in an increase of $ 13 million to net pension liabilities and 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 13), with the exception of certain amounts for termination benefits, curtailments and settlements, which are recorded in Restructuring costs if the event giving rise to the termination benefits, curtailment or settlement related to restructuring actions. - 25 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 13. Other (Income) Expense, Net Other (income) expense, net, consisted of: Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 Interest income $ ( 73 ) $ ( 40 ) $ ( 295 ) $ ( 62 ) Interest expense 317 244 836 727 Exchange losses 85 96 208 220 Loss (income) from investments in equity securities, net (1) 33 371 ( 240 ) 1,361 Net periodic defined benefit plan (credit) cost other than service cost ( 138 ) ( 60 ) ( 364 ) ( 208 ) Other, net ( 98 ) ( 182 ) 243 ( 462 ) $ 126 $ 429 $ 388 $ 1,576 (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 nine months of 2023 includes a $ 572.5 million charge related to settlements with certain plaintiffs in the Zetia antitrust litigation (see Note 10). Interest paid for the nine months ended September 30, 2023 and 2022 was $ 678 million and $ 660 million, respectively. 14. Income Taxes The effective income tax rate of 15.5 % for the third quarter of 2023 reflects the favorable mix of income and expense. The effective income tax rate of 59.3 % for the first nine months of 2023 includes a 44.0 percentage point combined unfavorable impact of charges for the acquisitions of Prometheus and Imago for which no tax benefits were recognized, as well as higher foreign taxes, the impact of the R&D capitalization provision of the Tax Cuts and Jobs Act of 2017 (TCJA) 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 rates of 9.2 % for the third quarter of 2022 and 11.0 % for the first nine months of 2022 reflect the favorable mix of income and expense, as well as the favorable impact of net unrealized losses from investments in equity securities and intangible asset impairment charges, which were taxed at the U.S. tax rate. The Internal Revenue Service (IRS) is currently conducting examinations of the Company’s tax returns for the years 2017 and 2018, including the one-time transition tax enacted under the TCJA. If the IRS disagrees with the Company’s transition tax position, it may result in a significant tax liability. 15. Earnings Per Share The calculations of earnings per share are as follows: Three Months Ended September 30, Nine Months Ended September 30, ($ and shares in millions except per share amounts) 2023 2022 2023 2022 Net Income Attributable to Merck & Co., Inc. $ 4,745 $ 3,248 $ 1,591 $ 11,502 Average common shares outstanding 2,537 2,533 2,538 2,531 Common shares issuable (1) 9 9 11 9 Average common shares outstanding assuming dilution 2,546 2,542 2,549 2,540 Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders $ 1.87 $ 1.28 $ 0.63 $ 4.55 Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders $ 1.86 $ 1.28 $ 0.62 $ 4.53 (1) Issuable primarily under share-based compensation plans. For the third quarter of 2023 and 2022, 6 million and 2 million, respectively, and for the first nine months of 2023 and 2022, 5 million and 5 million, respectively, of common shares issuable under share-based compensation plans were excluded from the computations of earnings per common share assuming dilution because the effect would have been antidilutive. - 26 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 16. Other Comprehensive Income (Loss) Changes in each component of other comprehensive income (loss) are as follows: Three Months Ended September 30, ($ in millions) Derivatives Employee Benefit Plans Foreign Currency Translation Adjustment Accumulated Other Comprehensive Loss Balance July 1, 2022, net of taxes $ 390 $ ( 2,465 ) $ ( 2,252 ) $ ( 4,327 ) Other comprehensive income (loss) before reclassification adjustments, pretax 682 ( 294 ) ( 618 ) ( 230 ) Tax ( 143 ) 62 50 ( 31 ) Other comprehensive income (loss) before reclassification adjustments, net of taxes 539 ( 232 ) ( 568 ) ( 261 ) Reclassification adjustments, pretax ( 254 ) (1) 77 (2) — ( 177 ) Tax 53 ( 31 ) — 22 Reclassification adjustments, net of taxes ( 201 ) 46 — ( 155 ) Other comprehensive income (loss), net of taxes 338 ( 186 ) ( 568 ) ( 416 ) Balance September 30, 2022, net of taxes $ 728 $ ( 2,651 ) $ ( 2,820 ) $ ( 4,743 ) Balance July 1, 2023, net of taxes $ 85 $ ( 2,483 ) $ ( 2,502 ) $ ( 4,900 ) Other comprehensive income (loss) before reclassification adjustments, pretax 247 29 ( 252 ) 24 Tax ( 52 ) ( 7 ) 77 18 Other comprehensive income (loss) before reclassification adjustments, net of taxes 195 22 ( 175 ) 42 Reclassification adjustments, pretax ( 45 ) (1) ( 27 ) (2) — ( 72 ) Tax 9 5 — 14 Reclassification adjustments, net of taxes ( 36 ) ( 22 ) — ( 58 ) Other comprehensive income (loss), net of taxes 159 — ( 175 ) ( 16 ) Balance September 30, 2023, net of taxes $ 244 $ ( 2,483 ) $ ( 2,677 ) $ ( 4,916 ) Nine Months Ended September 30, ($ in millions) Derivatives Employee Benefit Plans Foreign Currency Translation Adjustment Accumulated Other Comprehensive Loss Balance January 1, 2022, net of taxes $ 144 $ ( 2,743 ) $ ( 1,830 ) $ ( 4,429 ) Other comprehensive income (loss) before reclassification adjustments, pretax 1,233 ( 125 ) ( 1,001 ) 107 Tax ( 259 ) 25 11 ( 223 ) Other comprehensive income (loss) before reclassification adjustments, net of taxes 974 ( 100 ) ( 990 ) ( 116 ) Reclassification adjustments, pretax ( 493 ) (1) 266 (2) — ( 227 ) Tax 103 ( 74 ) — 29 Reclassification adjustments, net of taxes ( 390 ) 192 — ( 198 ) Other comprehensive income (loss), net of taxes 584 92 ( 990 ) ( 314 ) Balance September 30, 2022, net of taxes $ 728 $ ( 2,651 ) $ ( 2,820 ) $ ( 4,743 ) Balance January 1, 2023, net of taxes $ 73 $ ( 2,408 ) $ ( 2,433 ) $ ( 4,768 ) Other comprehensive income (loss) before reclassification adjustments, pretax 375 ( 24 ) ( 288 ) 63 Tax ( 79 ) ( 4 ) 35 ( 48 ) Other comprehensive income (loss) before reclassification adjustments, net of taxes 296 ( 28 ) ( 253 ) 15 Reclassification adjustments, pretax ( 158 ) (1) ( 57 ) (2) 9 ( 206 ) Tax 33 10 — 43 Reclassification adjustments, net of taxes ( 125 ) ( 47 ) 9 ( 163 ) Other comprehensive income (loss), net of taxes 171 ( 75 ) ( 244 ) ( 148 ) Balance September 30, 2023, net of taxes $ 244 $ ( 2,483 ) $ ( 2,677 ) $ ( 4,916 ) (1) Primarily relates to foreign currency cash flow hedges that were reclassified from AOCL to Sales . (2) Includes net amortization of prior service cost/credit, actuarial gains and losses, settlements and curtailments included in net periodic benefit cost (see Note 12). - 27 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) 17. 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. - 28 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) Sales of the Company’s products were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 ($ in millions) U.S. Int’l Total U.S. Int’l Total U.S. Int’l Total U.S. Int’l Total Pharmaceutical: Oncology Keytruda $ 3,795 $ 2,543 $ 6,338 $ 3,331 $ 2,095 $ 5,426 $ 11,142 $ 7,261 $ 18,403 $ 9,307 $ 6,180 $ 15,487 Alliance revenue-Lynparza (1) 153 146 299 144 140 284 439 445 884 427 397 825 Alliance revenue-Lenvima (1) 160 100 260 142 60 202 476 258 734 426 235 660 Welireg 51 3 54 38 — 38 141 6 146 83 — 83 Alliance revenue-Reblozyl (2) 43 10 52 32 7 39 108 33 142 87 37 124 Vaccines Gardasil/Gardasil 9 838 1,746 2,585 957 1,337 2,294 1,718 5,297 7,015 1,803 3,624 5,428 ProQuad/M-M-R II /Varivax 567 146 713 532 136 668 1,435 388 1,823 1,337 379 1,716 RotaTeq 108 48 156 154 102 256 381 203 584 427 218 644 Vaxneuvance 182 33 214 15 1 16 423 65 488 31 1 32 Pneumovax 23 42 98 140 68 63 131 105 223 327 280 177 457 Vaqta 32 37 69 27 36 64 91 60 151 72 62 134 Hospital Acute Care Bridion 265 159 424 233 190 423 841 572 1,413 665 579 1,244 Prevymis 70 87 157 49 64 114 186 244 430 136 174 310 Dificid 69 5 74 72 6 77 199 16 215 184 12 196 Primaxin — 41 41 — 63 63 2 173 174 1 185 185 Noxafil 4 47 51 13 49 62 29 138 167 39 141 180 Zerbaxa 29 24 53 24 19 43 86 71 157 64 55 120 Cardiovascular Alliance revenue-Adempas/Verquvo (3) 96 ( 4 ) 92 85 3 88 249 10 259 244 14 258 Adempas — 65 65 — 57 57 — 189 189 — 181 181 Virology Lagevrio — 640 640 — 436 436 — 1,236 1,236 1,523 3,336 4,859 Isentress/Isentress HD 58 61 119 68 93 161 165 212 377 196 270 466 Neuroscience Belsomra 23 35 58 20 42 62 60 117 176 60 139 199 Immunology Simponi — 179 179 — 173 173 — 539 539 — 540 540 Remicade — 45 45 — 49 49 — 144 144 — 163 163 Diabetes Januvia 328 252 581 332 385 717 842 800 1,642 958 1,294 2,252 Janumet 43 211 255 90 327 417 182 755 937 258 1,089 1,347 Other pharmaceutical (4) 197 353 549 194 410 603 540 1,147 1,690 511 1,225 1,736 Total Pharmaceutical segment sales 7,153 7,110 14,263 6,620 6,343 12,963 19,840 20,602 40,442 19,119 20,707 39,826 Animal Health: Livestock 205 669 874 186 643 829 543 1,987 2,530 521 1,965 2,486 Companion Animal 257 269 526 289 253 542 875 942 1,817 904 929 1,834 Total Animal Health segment sales 462 938 1,400 475 896 1,371 1,418 2,929 4,347 1,425 2,894 4,320 Total segment sales 7,615 8,048 15,663 7,095 7,239 14,334 21,258 23,531 44,789 20,544 23,601 44,146 Other (5) 100 199 299 227 398 625 135 561 696 383 925 1,307 $ 7,715 $ 8,247 $ 15,962 $ 7,322 $ 7,637 $ 14,959 $ 21,393 $ 24,092 $ 45,485 $ 20,927 $ 24,526 $ 45,453 U.S. plus international may not equal total due to rounding. (1) Alliance revenue for Lynparza and Lenvima represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs (see Note 3). (2) Alliance revenue for Reblozyl represents royalties and, for the first nine months of 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 $ 173 million and $ 533 million for the nine months ended September 30, 2023 and 2022, respectively, as well as revenue from third-party manufacturing arrangements (including sales to Organon). Other for the nine months ended September 30, 2023 and 2022 also includes $ 118 million and $ 156 million, respectively, related to upfront and milestone payments received by Merck for out-licensing arrangements. - 29 - Notes to Condensed Consolidated Financial Statements (unaudited) (continued) Product sales are recorded net of the provision for discounts, including chargebacks, which are customer discounts that occur when a contracted customer purchases through an intermediary wholesale purchaser, and rebates that are owed based upon definitive contractual agreements or legal requirements with private sector and public sector (Medicaid and Medicare Part D) benefit providers, after the final dispensing of the product by a pharmacy to a benefit plan participant. These discounts, in the aggregate, reduced U.S. sales by $ 3.1 billion and $ 3.3 billion for the three months ended September 30, 2023 and 2022, respectively, and $ 9.4 billion and $ 9.1 billion for the nine months ended September 30, 2023 and 2022, respectively. Consolidated sales by geographic area where derived are as follows: Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 United States $ 7,715 $ 7,322 $ 21,393 $ 20,927 Europe, Middle East and Africa 3,327 3,286 9,978 11,228 China 1,694 1,442 5,322 3,957 Japan 1,081 673 2,514 2,776 Asia Pacific (other than China and Japan) 781 854 2,475 2,792 Latin America 895 684 2,298 1,933 Other 469 698 1,505 1,840 $ 15,962 $ 14,959 $ 45,485 $ 45,453 A reconciliation of segment profits to Income Before Taxes is as follows: Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) 2023 2022 2023 2022 Segment profits: Pharmaceutical segment $ 10,407 $ 9,590 $ 29,400 $ 28,263 Animal Health segment 421 515 1,453 1,672 Total segment profits 10,828 10,105 30,853 29,935 Other profits 190 377 374 831 Unallocated: Interest income 73 40 295 62 Interest expense ( 317 ) ( 244 ) ( 836 ) ( 727 ) Amortization ( 562 ) ( 460 ) ( 1,582 ) ( 1,623 ) Depreciation ( 401 ) ( 448 ) ( 1,175 ) ( 1,257 ) Research and development ( 3,183 ) ( 4,277 ) ( 20,523 ) ( 9,374 ) Restructuring costs ( 126 ) ( 94 ) ( 344 ) ( 288 ) Charge for Zetia antitrust litigation settlements — — ( 573 ) — Other unallocated, net ( 882 ) ( 1,416 ) ( 2,554 ) ( 4,628 ) $ 5,620 $ 3,583 $ 3,935 $ 12,931 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, 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. - 30 -