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.) 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 26, 2024.
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 Issued Accounting Standards Not Yet Adopted
In August 2023, the Financial Accounting Standards Board (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.
In November 2023, the FASB issued guidance intended to improve reportable segment disclosure requirements, primarily through expanded disclosures for significant segment expenses. The guidance is effective for annual periods beginning in 2024, and interim periods beginning in 2025. The guidance will result in incremental disclosures within the footnotes to the Company’s financial statements.
In December 2023, the FASB issued guidance intended to improve the transparency of income tax disclosures by requiring consistent categories and disaggregation of information in the effective income tax rate reconciliation and income taxes paid disclosures by jurisdiction. The guidance also includes other amendments to improve the effectiveness of income tax disclosures by removing certain previously required disclosures. The guidance is effective for 2025 annual reporting. Early adoption is permitted. The guidance will result in incremental disclosures within the footnotes to the Company’s financial statements.
2. Acquisitions, Divestitures, 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.
2024 Transactions
In March 2024, Merck acquired Harpoon Therapeutics, Inc. (Harpoon), a clinical-stage immunotherapy company developing a novel class of T-cell engagers designed to harness the power of the body’s immune system to treat patients suffering from cancer and other diseases, for $765 million and also incurred $56 million of transaction costs. Harpoon’s lead candidate, MK-6070 (formerly HPN328), is a T-cell engager targeting delta-like ligand 3 (DLL3), an inhibitory canonical Notch ligand that is expressed at high levels in small-cell lung cancer (SCLC) and neuroendocrine tumors. MK-6070 is currently being evaluated as monotherapy in a Phase 1/2 clinical trial in certain patients with advanced cancers associated with expression of DLL3. The study is also evaluating MK-6070 in combination with atezolizumab in certain patients with SCLC. The transaction was accounted for as an asset acquisition since MK-6070 represented substantially all of the fair value of the gross assets acquired (excluding cash and deferred income taxes). Merck recorded net assets of $165 million, as well as a charge of $656 million to Research and development expenses in the first quarter of 2024 related to the transaction. There are no future contingent payments associated with the acquisition.
In February 2024, Merck entered into a definitive agreement to acquire the aqua business of Elanco Animal Health Incorporated (Elanco) for $1.3 billion in cash. The Elanco aqua business to be acquired consists of an innovative portfolio of medicines and vaccines, nutritionals and supplements for aquatic species; two related aqua manufacturing facilities in Canada and Vietnam; as well as a research facility in Chile. Upon closing, the acquisition will broaden Animal Health’s aqua portfolio with products, such as Clynav, a new generation DNA-based vaccine that protects Atlantic salmon against pancreas disease, and Imvixa, an anti-parasitic sea lice treatment. This acquisition also brings a portfolio of water treatment products for warm water production, complementing Animal Health’s warm water vaccine portfolio. In addition to these products, the DNA-based vaccine
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
technology that is a part of the business has the potential to accelerate the development of novel vaccines to address the unmet needs of the aqua industry. The acquisition is expected to be completed by mid-2024, subject to approvals from regulatory authorities and other customary closing conditions. The transaction will be accounted for as a business combination.
2023 Transactions
In February 2023, Merck and Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd.) closed a license and collaboration agreement expanding their relationship in which Merck gained exclusive rights for the research, development, manufacture and commercialization of up to seven investigational preclinical antibody drug conjugates (ADCs) for the treatment of cancer. Kelun-Biotech retained the right to research, develop, manufacture and commercialize certain licensed and option ADCs for Chinese mainland, Hong Kong and Macau. Merck made an upfront payment of $175 million, which was recorded as a charge to Research and development expenses in the first quarter of 2023. In October 2023, Merck notified Kelun-Biotech it was terminating two of the seven candidates under the agreement. Subsequently, in April 2024, Merck notified Kelun-Biotech it was terminating an additional candidate under the agreement. Kelun-Biotech remains eligible to receive future contingent payments aggregating up to $600 million in development-related payments, $1.6 billion in regulatory milestones, and $3.1 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 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 clinical trials for the treatment of essential thrombocythemia, myelofibrosis, and polycythemia vera, in addition to other indications. A Phase 3 clinical trial evaluating bomedemstat for the treatment of certain patients with essential thrombocythemia is underway. 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 quarter of 2023 related to the transaction. There are no future contingent payments associated with the acquisition.
Spin-Off of Organon & Co.
In connection with the 2021 spin-off of Organon & Co. (Organon), Merck and Organon 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 continued to market, import and distribute such products on behalf of Organon until such time as the relevant licenses and permits transferred to Organon, with Organon receiving all of the economic benefits and burdens of such activities. As of March 31, 2024, only one jurisdiction remains under an interim operating agreement. Additionally, Merck and Organon entered into a number of manufacturing and supply agreements (MSAs) with terms ranging from four years to ten years. The amounts included in the condensed consolidated statement of income for the above MSAs include sales of $107 million and $94 million and related cost of sales of $110 million and $107 million for the first quarter of 2024 and 2023, respectively. The amounts due from Organon for all spin-off related agreements were $462 million and $632 million at March 31, 2024 and December 31, 2023, respectively, and are reflected in Other current assets. The amounts due to Organon under these agreements were $193 million and $598 million at March 31, 2024 and December 31, 2023, respectively, and are included in Accrued and other current liabilities.
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 are developing and commercializing 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 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.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
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 2022, Merck determined it was probable that sales of Lynparza in the future would trigger a $600 million sales-based milestone payment from Merck to AstraZeneca. Accordingly, Merck recorded a $600 million liability (which remained accrued at March 31, 2024) and a corresponding increase to the intangible asset related to Lynparza. 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. Lynparza received regulatory approvals triggering capitalized milestone payments from Merck to AstraZeneca of $245 million and $105 million in the first quarter of 2024 and 2023, respectively (each of which had been previously accrued for). Potential future regulatory milestone payments of $650 million remain under the agreement.
The intangible asset balance related to Lynparza (which includes capitalized sales-based and regulatory milestone payments) was $1.4 billion at March 31, 2024 and is included in Other Intangibles, Net. The amount is being amortized over its estimated useful life through 2028 as supported by projected future cash flows, subject to impairment testing.
Summarized financial information related to this collaboration is as follows:
| | | | | | | | | | | | | | | |
| Three Months Ended
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
| Alliance revenue - Lynparza | $ | 292 | | | $ | 275 | | | | | |
| Alliance revenue - Koselugo | 38 | | | 23 | | | | | |
| Total alliance revenue | $ | 330 | | | $ | 298 | | | | | |
| | | | | | | |
Cost of sales (1) | 82 | | | 70 | | | | | |
| Selling, general and administrative | 39 | | | 47 | | | | | |
| Research and development | 20 | | | 21 | | | | | |
| | | | | | | |
| ($ in millions) | March 31, 2024 | | December 31, 2023 | | | | |
Receivables from AstraZeneca included in Other current assets | $ | 334 | | | $ | 341 | | | | | |
Payables to AstraZeneca included in Accrued and other current liabilities (2) | 617 | | | 256 | | | | | |
Payables to AstraZeneca included in Other Noncurrent Liabilities (2) | — | | | 600 | | | | | |
(1) Represents amortization of capitalized milestone payments.
(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 are developing and commercializing 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 by the Company to be probable of payment. Accordingly, Merck recorded $250 million of liabilities for these payments (of which $125 million was subsequently paid in the second quarter of 2023 and $125 million remained accrued at March 31, 2024) and corresponding increases to the intangible asset related to Lenvima. Merck also recognized $72 million and $81 million of cumulative amortization catch-up expense related to the recognition of these milestones in the first and third quarters of 2023, respectively. 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. 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 $623 million at March 31, 2024 and is included in Other Intangibles, Net. The amount is being amortized over its estimated useful life through 2026 as supported by projected future cash flows, subject to impairment testing.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Summarized financial information related to this collaboration is as follows:
| | | | | | | | | | | | | | | |
| Three Months Ended
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
| Alliance revenue - Lenvima | $ | 255 | | | $ | 232 | | | | | |
| | | | | | | |
Cost of sales (1) | 60 | | | 126 | | | | | |
| Selling, general and administrative | 39 | | | 51 | | | | | |
| Research and development | 8 | | | 39 | | | | | |
| | | | | | | |
| ($ in millions) | March 31, 2024 | | December 31, 2023 | | | | |
Receivables from Eisai included in Other current assets | $ | 255 | | | $ | 226 | | | | | |
Payables to Eisai included in Accrued and other current liabilities (2) | 125 | | | 125 | | | | | |
(1) Represents amortization of capitalized milestone payments. Amount in the first quarter of 2023 includes $72 million of cumulative amortization catch-up expense as noted above.
(2) Represents an accrued milestone payment.
Bayer AG
In 2014, the Company entered into a worldwide clinical development collaboration with Bayer AG (Bayer) to market and develop soluble guanylate cyclase (sGC) modulators including Bayer’s Adempas (riociguat) and Verquvo (vericiguat). The two companies have implemented a joint development and commercialization strategy. 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. There are no sales-based milestone payments remaining under this collaboration.
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 $483 million and $49 million, respectively, at March 31, 2024 and are included in Other Intangibles, Net. The assets are being amortized over their estimated useful lives (through 2027 for Adempas and through 2031 for Verquvo) as supported by projected future cash flows, subject to impairment testing.
Summarized financial information related to this collaboration is as follows:
| | | | | | | | | | | | | | | |
| Three Months Ended
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
| Alliance revenue - Adempas/Verquvo | $ | 98 | | | $ | 99 | | | | | |
| Net sales of Adempas recorded by Merck | 70 | | | 59 | | | | | |
| Net sales of Verquvo recorded by Merck | 5 | | | 7 | | | | | |
| Total sales | $ | 173 | | | $ | 165 | | | | | |
| | | | | | | |
Cost of sales (1) | 62 | | | 57 | | | | | |
| Selling, general and administrative | 33 | | | 33 | | | | | |
| Research and development | 28 | | | 25 | | | | | |
| | | | | | | |
| ($ in millions) | March 31, 2024 | | December 31, 2023 | | | | |
Receivables from Bayer included in Other current assets | $ | 155 | | | $ | 156 | | | | | |
Payables to Bayer included in Accrued and other current liabilities | 74 | | | 80 | | | | | |
(1) Includes amortization of intangible assets, cost of products sold by Merck, as well as Bayer’s share of profits from sales in Merck’s marketing territories.
Ridgeback Biotherapeutics LP
In 2020, Merck and Ridgeback Biotherapeutics LP (Ridgeback), a closely held biotechnology company, entered into a collaboration agreement to develop Lagevrio (molnupiravir), an investigational orally available antiviral candidate for the treatment of patients with COVID-19. Merck gained exclusive worldwide rights to develop and commercialize Lagevrio and related molecules. Following initial authorizations in certain markets in the fourth quarter of 2021, Lagevrio has since received multiple additional authorizations.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
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
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
Net sales of Lagevrio recorded by Merck | $ | 350 | | | $ | 392 | | | | | |
| | | | | | | |
Cost of sales (1) | 191 | | | 221 | | | | | |
Selling, general and administrative | 16 | | | 27 | | | | | |
Research and development | (5) | | | 16 | | | | | |
| | | | | | | |
| ($ in millions) | March 31, 2024 | | December 31, 2023 | | | | |
Payables to Ridgeback included in Accrued and other current liabilities (2) | $ | 160 | | | $ | 113 | | | | | |
(1) Includes cost of products sold by Merck, Ridgeback’s share of profits, royalty expense, amortization of capitalized milestone payments and inventory reserves.
(2) Includes accrued royalties.
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 in 2023. 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. If Merck does not make the continuation payments on the dates noted for either patritumab deruxtecan and/or raludotatug deruxtecan, the rights for the applicable program will revert to Daiichi Sankyo and the non-refundable upfront payments already paid will be retained by 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. In conjunction with this transaction, Merck recorded an aggregate pretax charge of $5.5 billion to Research and development expenses in the fourth quarter of 2023 for the $4.0 billion of upfront payments and the $1.5 billion of continuation payments.
Merck and Daiichi Sankyo will equally share research and development costs, except for raludotatug deruxtecan, where Merck will be responsible for 75% of the first $2.0 billion of research and development expenses. Merck includes its share of development costs associated with the collaboration as part of Research and development expenses. Following regulatory approval, Daiichi Sankyo will generally record sales worldwide (Daiichi Sankyo will be the principal on sales transactions) and the companies will equally share expenses as well as profits worldwide except for Japan where Daiichi Sankyo retains exclusive rights and Merck will receive a 5% sales-based royalty. Merck will record its share of product sales, net of cost of sales and commercialization costs, as alliance revenue.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Summarized financial information related to this collaboration is as follows:
| | | | | | | | | | | | | | | |
| Three Months Ended
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
| Selling, general and administrative | $ | 3 | | | $ | — | | | | | |
Research and development | 69 | | | — | | | | | |
| | | | | | | |
| ($ in millions) | March 31, 2024 | | December 31, 2023 | | | | |
Payables to Daiichi Sankyo included in Accrued and other current liabilities | $ | 817 | | | $ | 800 | | | | | |
Payables to Daiichi Sankyo included in Other Noncurrent Liabilities | 750 | | | 750 | | | | | |
Moderna, Inc.
In 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). V940 (mRNA-4157) is currently being evaluated in combination with Keytruda in multiple Phase 3 clinical trials. Merck and Moderna will share costs and any profits equally under this worldwide collaboration. Merck records its share of development costs associated with the collaboration as part of Research and development expenses. Any reimbursements received from Moderna for research and development expenses are recognized as reductions to Research and development costs. Merck has also capitalized certain of the shared costs, which aggregated $110 million at March 31, 2024 and will be amortized over the assets’ estimated useful lives.
Summarized financial information related to this collaboration is as follows:
| | | | | | | | | | | | | | | |
| Three Months Ended
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
| Selling, general and administrative | $ | 2 | | | $ | 1 | | | | | |
Research and development | 69 | | | 26 | | | | | |
| | | | | | | |
| ($ in millions) | March 31, 2024 | | December 31, 2023 | | | | |
Payables to Moderna included in Accrued and other current liabilities | $ | 72 | | | $ | 63 | | | | | |
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 tiered royalties ranging from 20% to 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, consisting of royalties (recorded within Sales) was $71 million and $43 million in the first quarter of 2024 and 2023, respectively.
4. Restructuring
In January 2024, the Company approved a new restructuring program (2024 Restructuring Program) intended to continue the optimization of the Company’s Human Health global manufacturing network as the future pipeline shifts to new modalities and also optimize the Animal Health global manufacturing network to improve supply reliability and increase efficiency. The actions contemplated under the 2024 Restructuring Program are expected to be substantially completed by the end of 2031, with the cumulative pretax costs to be incurred by the Company to implement the program estimated to be approximately $4.0 billion. Approximately 60% of the cumulative pretax costs will be non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested. The remainder of the costs will result in cash outlays, relating primarily to facility shut-down costs. The Company recorded total pretax costs of $246 million in the first quarter of 2024 related to the 2024 Restructuring Program, bringing total cumulative pretax costs incurred through March 31, 2024 to $436 million.
In 2019, Merck approved a global restructuring program (2019 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 Company recorded total pretax costs of $97 million in the first quarter of 2023 related to the 2019 Restructuring Program. The actions under the 2019 Restructuring Program were substantially complete at the end of 2023 and, as of January 1, 2024, any remaining activities are now being accounted for as part of the 2024 Restructuring Program.
For segment reporting, restructuring charges are unallocated expenses.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
The following tables summarize the charges related to the restructuring programs by type of cost:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, 2024 | | |
| ($ in millions) | Accelerated Depreciation | | Separation Costs | | Other Exit Costs | | Total | | | | | | | | |
| 2024 Restructuring Program | | | | | | | | | | | | | | | |
| Cost of sales | $ | 65 | | | $ | — | | | $ | 51 | | | $ | 116 | | | | | | | | | |
| Selling, general and administrative | — | | | — | | | 5 | | | 5 | | | | | | | | | |
| Research and development | — | | | — | | | 2 | | | 2 | | | | | | | | | |
| Restructuring costs | — | | | 92 | | | 31 | | | 123 | | | | | | | | | |
| $ | 65 | | | $ | 92 | | | $ | 89 | | | $ | 246 | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, 2023 | | |
| ($ in millions) | Accelerated Depreciation | | Separation Costs | | Other Exit Costs | | Total | | | | | | | | |
2019 Restructuring Program | | | | | | | | | | | | | | | |
| Cost of sales | $ | 21 | | | $ | — | | | $ | 8 | | | $ | 29 | | | | | | | | | |
| Selling, general and administrative | — | | | — | | | 1 | | | 1 | | | | | | | | | |
| | | | | | | | | | | | | | | |
| Restructuring costs | — | | | 41 | | | 26 | | | 67 | | | | | | | | | |
| $ | 21 | | | $ | 41 | | | $ | 35 | | | $ | 97 | | | | | | | | | |
Accelerated depreciation costs primarily relate to manufacturing, research and administrative facilities and equipment to be sold or closed as part of the programs. Accelerated depreciation costs represent the difference between the depreciation expense to be recognized over the revised useful life of the 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 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.
Separation costs are associated with actual headcount reductions, as well as involuntary headcount reductions which were probable and could be reasonably estimated.
Other exit costs in 2024 and 2023 include 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 9) and share-based compensation.
The following table summarizes the charges and spending relating to restructuring program activities for the three months ended March 31, 2024:
| | | | | | | | | | | | | | | | | | | | | | | |
| ($ in millions) | Accelerated Depreciation | | Separation Costs | | Other Exit Costs | | Total |
Restructuring reserves January 1, 2024 | $ | — | | | $ | 681 | | | $ | 31 | | | $ | 712 | |
| Expenses | 65 | | | 92 | | | 89 | | | 246 | |
| (Payments) receipts, net | — | | | (67) | | | (32) | | | (99) | |
| Non-cash activity | (65) | | | — | | | (58) | | | (123) | |
Restructuring reserves March 31, 2024 | $ | — | | | $ | 706 | | | $ | 30 | | | $ | 736 | |
5. Financial Instruments
Derivative Instruments and Hedging Activities
The Company manages the impact of foreign exchange rate movements and interest rate movements on its earnings, cash flows and fair values of assets and liabilities through operational means and through the use of various financial instruments, including derivative instruments.
A significant portion of the 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.
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 foreign 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 foreign 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 foreign 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 foreign exchange rate and the cost of the hedging instrument (primarily the euro, Swiss franc, Japanese yen, and Chinese renminbi). 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 foreign 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 Income are shown below:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Amount of Pretax (Gain) Loss Recognized in Other Comprehensive Income (1) | | Amount of Pretax Loss Recognized in Other (income) expense, net for Amounts Excluded from Effectiveness Testing |
| Three Months Ended March 31, | | | | Three Months Ended March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | | | 2024 | | 2023 | | | | |
| Net Investment Hedging Relationships | | | | | | | | | | | | | | | |
| Foreign exchange contracts | $ | (2) | | | $ | 1 | | | | | | | $ | — | | | $ | 1 | | | | | |
| Euro-denominated notes | (62) | | | 52 | | | | | | | — | | | — | | | | | |
(1) No amounts were reclassified from AOCL into income related to the sale of a subsidiary.
Interest Rate Risk Management
The Company may use interest rate swap contracts on certain investing and borrowing transactions to manage its net exposure to interest rate changes and to reduce its overall cost of borrowing. The Company does not use leveraged swaps and, in general, does not leverage any of its investment activities that would put principal at risk.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
At March 31, 2024, the Company was a party to four 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.
| | | | | | | | | | | | | | | | | |
| March 31, 2024 |
($ in millions) | Par Value of Debt | | Number of Interest Rate Swaps Held | | Total Swap Notional Amount |
4.50% notes due 2033 | $ | 1,500 | | | 4 | | | $ | 1,000 | |
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 changes 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. The cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows. In April 2024, the Company entered into two additional interest rate swaps with notional amounts of $250 million each also related to its 4.50% notes due 2033.
The table below presents the location of amounts recorded in the Condensed Consolidated Balance Sheet related to cumulative basis adjustments for fair value hedges:
| | | | | | | | | | | | | | | | | | | | | | | |
| Carrying Amount of Hedged Liabilities | | Cumulative Amount of Fair Value Hedging Adjustment Increase Included in the Carrying Amount |
($ in millions) | March 31, 2024 | | December 31, 2023 | | March 31, 2024 | | December 31, 2023 |
Balance Sheet Caption | | | | | | | |
Long-Term Debt | $ | 1,026 | | | $ | 1,056 | | | $ | 26 | | | $ | 56 | |
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:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | March 31, 2024 | | December 31, 2023 |
| | | 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 Assets | $ | 27 | | | $ | — | | | $ | 1,000 | | | $ | 57 | | | $ | — | | | $ | 1,000 | |
| Foreign exchange contracts | Other current assets | 175 | | | — | | | 9,082 | | | 106 | | | — | | | 6,138 | |
| Foreign exchange contracts | Other Assets | 32 | | | — | | | 2,062 | | | 26 | | | — | | | 1,929 | |
| Foreign exchange contracts | Accrued and other current liabilities | — | | | 10 | | | 1,076 | | | — | | | 76 | | | 3,680 | |
| Foreign exchange contracts | Other Noncurrent Liabilities | — | | | 1 | | | 204 | | | — | | | 1 | | | 7 | |
| | | 234 | | | 11 | | | 13,424 | | | 189 | | | 77 | | | 12,754 | |
| Derivatives Not Designated as Hedging Instruments | Balance Sheet Caption | | | | | | | | | | | |
| Foreign exchange contracts | Other current assets | 121 | | | — | | | 9,428 | | | 153 | | | — | | | 9,693 | |
| Foreign exchange contracts | Other Assets | 2 | | | — | | | 43 | | | — | | | — | | | — | |
| Foreign exchange contracts | Accrued and other current liabilities | — | | | 154 | | | 9,282 | | | — | | | 162 | | | 8,104 | |
| Foreign exchange contracts | Other Noncurrent Liabilities | — | | | 2 | | | 43 | | | — | | | — | | | — | |
| | | 123 | | | 156 | | | 18,796 | | | 153 | | | 162 | | | 17,797 | |
| | | $ | 357 | | | $ | 167 | | | $ | 32,220 | | | $ | 342 | | | $ | 239 | | | $ | 30,551 | |
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:
| | | | | | | | | | | | | | | | | | | | | | | |
| | March 31, 2024 | | December 31, 2023 |
| ($ in millions) | Asset | | Liability | | Asset | | Liability |
| Gross amounts recognized in the condensed consolidated balance sheet | $ | 357 | | | $ | 167 | | | $ | 342 | | | $ | 239 | |
| Gross amounts subject to offset in master netting arrangements not offset in the condensed consolidated balance sheet | (111) | | | (111) | | | (215) | | | (215) | |
Cash collateral received | (58) | | | — | | | (3) | | | — | |
| Net amounts | $ | 188 | | | $ | 56 | | | $ | 124 | | | $ | 24 | |
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 March 31, | | |
| ($ in millions) | 2024 | | 2023 | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | |
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) | | | | | | |
| $ | 15,775 | | | $ | 14,487 | | | $ | (33) | | | $ | 89 | | | $ | (113) | | | $ | (115) | | | | | | | | | | | | | |
| (Gain) loss on fair value hedging relationships: | | | | | | | | | | | | | | | | | | | | | | | |
| Interest rate swap contracts | | | | | | | | | | | | | | | | | | | | | | | |
| Hedged items | — | | | — | | | (30) | | | — | | | — | | | — | | | | | | | | | | | | | |
| Derivatives designated as hedging instruments | — | | | — | | | 30 | | | — | | | — | | | — | | | | | | | | | | | | | |
| Impact of cash flow hedging relationships: | | | | | | | | | | | | | | | | | | | | | | | |
| Foreign exchange contracts | | | | | | | | | | | | | | | | | | | | | | | |
Amount of gain (loss) recognized in OCI on derivatives | — | | | — | | | — | | | — | | | 209 | | | (66) | | | | | | | | | | | | | |
Increase in Sales as a result of AOCL reclassifications | 44 | | | 101 | | | — | | | — | | | (44) | | | (101) | | | | | | | | | | | | | |
| Interest rate contracts | | | | | | | | | | | | | | | | | | | | | | | |
Amount of gain recognized in Other (income) expense, net on derivatives | — | | | — | | | — | | | (1) | | | — | | | — | | | | | | | | | | | | | |
Amount of loss recognized in OCI on derivatives | — | | | — | | | — | | | — | | | — | | | (1) | | | | | | | | | | | | | |
(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 March 31, | | |
| ($ in millions) | | | 2024 | | 2023 | | | | |
| Derivatives Not Designated as Hedging Instruments | Income Statement Caption | | | | | | | | |
Foreign exchange contracts (1) | Other (income) expense, net | | $ | 65 | | | $ | 13 | | | | | |
Foreign exchange contracts (2) | Sales | | (10) | | | 2 | | | | | |
(1) These derivative contracts primarily mitigate changes in the value of remeasured foreign currency denominated monetary assets and liabilities attributable to changes in foreign currency exchange rates.
(2) These derivative contracts serve as economic hedges of forecasted transactions.
At March 31, 2024, the Company estimates $113 million of pretax net unrealized gains on derivatives maturing within the next 12 months that hedge foreign currency denominated sales over that same period will be reclassified from AOCL to Sales. The amount ultimately reclassified to Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual foreign exchange rates at maturity.
Investments in Debt and Equity Securities
Information on investments in debt and equity securities is as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | March 31, 2024 | | December 31, 2023 |
| | Amortized
Cost | | Gross Unrealized | | Fair
Value | | Amortized
Cost | | Gross Unrealized | | Fair
Value |
| ($ in millions) | Gains | | Losses | | Gains | | Losses | |
| Commercial paper | $ | 40 | | | $ | — | | | $ | — | | | $ | 40 | | | $ | 252 | | | $ | — | | | $ | — | | | $ | 252 | |
| U.S. government and agency securities | 77 | | | — | | | — | | | 77 | | | 72 | | | — | | | — | | | 72 | |
| Corporate notes and bonds | — | | | — | | | — | | | — | | | 13 | | | — | | | — | | | 13 | |
| Total debt securities | $ | 117 | | | $ | — | | | $ | — | | | $ | 117 | | | $ | 337 | | | $ | — | | | $ | — | | | $ | 337 | |
Publicly traded equity securities (1) | | | | | | | 908 | | | | | | | | | 764 | |
| Total debt and publicly traded equity securities | | | | | | | $ | 1,025 | | | | | | | | | $ | 1,101 | |
(1) Unrealized net gains of $143 million were recorded in Other (income) expense, net in the first quarter of 2024 on equity securities still held at March 31, 2024. Unrealized net gains of $338 million were recorded in Other (income) expense, net in the first quarter of 2023 on equity securities still held at March 31, 2023.
At March 31, 2024 and March 31, 2023, the Company also had $851 million and $942 million, respectively, of equity investments without readily determinable fair values included in Other Assets. The Company records unrealized gains on these equity investments based on favorable observable price changes from transactions involving similar investments of the same investee and records unrealized losses based on unfavorable observable price changes, which are included in Other (income) expense, net. During the first quarter of 2024, the Company recorded unrealized gains of $4 million and unrealized losses of $5 million related to certain of these equity investments still held at March 31, 2024. During the first quarter of 2023, the Company recorded unrealized gains of $1 million and unrealized losses of $21 million related to certain of these equity investments still held at March 31, 2023. Cumulative unrealized gains and cumulative unrealized losses based on observable
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
price changes for investments in equity investments without readily determinable fair values still held at March 31, 2024 were $297 million and $69 million, respectively.
At March 31, 2024 and March 31, 2023, the Company also had $396 million and $725 million, respectively, recorded in Other Assets for equity securities held through ownership interests in investment funds. Losses (gains) recorded in Other (income) expense, net relating to these investment funds were $2 million and $(132) million for the first quarter of 2024 and 2023, respectively.
Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company uses a fair value hierarchy which maximizes the use of observable inputs and minimizes the use of unobservable inputs when measuring fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs that are supported by little or no market activity. Level 3 assets or liabilities are those whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques with significant unobservable inputs, as well as assets or liabilities for which the determination of fair value requires significant judgment or estimation.
If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.
Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis
Financial assets and liabilities measured at fair value on a recurring basis are summarized below:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fair Value Measurements Using | | Fair Value Measurements Using |
| | Level 1 | | Level 2 | | Level 3 | | Total | | Level 1 | | Level 2 | | Level 3 | | Total |
| ($ in millions) | March 31, 2024 | | December 31, 2023 |
| Assets | | | | | | | | | | | | | | | |
| Investments | | | | | | | | | | | | | | | |
| Commercial paper | $ | — | | | $ | 40 | | | $ | — | | | $ | 40 | | | $ | — | | | $ | 252 | | | $ | — | | | $ | 252 | |
| Publicly traded equity securities | 280 | | | — | | | — | | | 280 | | | 252 | | | — | | | — | | | 252 | |
| | 280 | | | 40 | | | — | | | 320 | | | 252 | | | 252 | | | — | | | 504 | |
Other assets (1) | | | | | | | | | | | | | | | |
| U.S. government and agency securities | 77 | | | — | | | — | | | 77 | | | 72 | | | — | | | — | | | 72 | |
| Corporate notes and bonds | — | | | — | | | — | | | — | | | 13 | | | — | | | — | | | 13 | |
Publicly traded equity securities (2) | 628 | | | — | | | — | | | 628 | | | 512 | | | — | | | — | | | 512 | |
| 705 | | | — | | | — | | | 705 | | | 597 | | | — | | | — | | | 597 | |
Derivative assets (3) | | | | | | | | | | | | | | | |
| Forward exchange contracts | — | | | 204 | | | — | | | 204 | | | — | | | 202 | | | — | | | 202 | |
| Purchased currency options | — | | | 126 | | | — | | | 126 | | | — | | | 83 | | | — | | | 83 | |
Interest rate swaps | — | | | 27 | | | — | | | 27 | | | — | | | 57 | | | — | | | 57 | |
| | — | | | 357 | | | — | | | 357 | | | — | | | 342 | | | — | | | 342 | |
| Total assets | $ | 985 | | | $ | 397 | | | $ | — | | | $ | 1,382 | | | $ | 849 | | | $ | 594 | | | $ | — | | | $ | 1,443 | |
| Liabilities | | | | | | | | | | | | | | | |
| Other liabilities | | | | | | | | | | | | | | | |
| Contingent consideration | $ | — | | | $ | — | | | $ | 226 | | | $ | 226 | | | $ | — | | | $ | — | | | $ | 354 | | | $ | 354 | |
Derivative liabilities (3) | | | | | | | | | | | | | | | |
| Forward exchange contracts | — | | | 149 | | | — | | | 149 | | | — | | | 239 | | | — | | | 239 | |
| Written currency options | — | | | 18 | | | — | | | 18 | | | — | | | — | | | — | | | — | |
| — | | | 167 | | | — | | | 167 | | | — | | | 239 | | | — | | | 239 | |
| Total liabilities | $ | — | | | $ | 167 | | | $ | 226 | | | $ | 393 | | | $ | — | | | $ | 239 | | | $ | 354 | | | $ | 593 | |
(1) Investments included in other assets are restricted as to use, including for the payment of benefits under employee benefit plans.
(2) Balance at March 31, 2024 includes securities with a fair value of $266 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 March 31, 2024 and December 31, 2023, Cash and cash equivalents included $4.6 billion and $6.0 billion of cash equivalents, respectively (which would be considered Level 2 in the fair value hierarchy).
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Contingent Consideration
Summarized information about the changes in the fair value of liabilities for contingent consideration associated with business combinations is as follows:
| | | | | | | | | | | |
| ($ in millions) | 2024 | | 2023 |
| Fair value January 1 | $ | 354 | | | $ | 456 | |
Changes in estimated fair value (1) | (2) | | | 14 | |
| Payments | (126) | | | (117) | |
Fair value March 31 (2) | $ | 226 | | | $ | 353 | |
(1) Recorded in Cost of sales, Research and development expenses, and Other (income) expense, net. Includes cumulative translation adjustments.
(2) Balance at March 31, 2024, includes $133 million of current liabilities, all of which 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.
The payments of contingent consideration in both periods relate to the Sanofi Pasteur MSD liabilities described above.
Other Fair Value Measurements
Some of the Company’s financial instruments, such as cash and cash equivalents, receivables and payables, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature.
The estimated fair value of loans payable and long-term debt (including current portion) at March 31, 2024, was $30.4 billion compared with a carrying value of $34.2 billion and at December 31, 2023, was $32.0 billion compared with a carrying value of $35.1 billion. Fair value was estimated using recent observable market prices and would be considered Level 2 in the fair value hierarchy.
Concentrations of Credit Risk
On an ongoing basis, the Company monitors concentrations of credit risk associated with corporate and government issuers of securities and financial institutions with which it conducts business. Credit exposure limits are established to limit a concentration with any single issuer or institution. Cash and investments are placed in instruments that meet high credit quality standards as specified in the Company’s investment policy guidelines.
The majority of the Company’s accounts receivable arise from product sales in the U.S., Europe and China and are primarily due from drug wholesalers, 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 $2.7 billion and $3.0 billion of accounts receivable as of March 31, 2024 and December 31, 2023, 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 March 31, 2024 and December 31, 2023, the Company had collected $43 million and $44 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 $58 million and $3 million at March 31, 2024 and December 31, 2023, respectively. The obligation to return such collateral is recorded in Accrued and other current liabilities.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
6. Inventories
Inventories consisted of:
| | | | | | | | | | | |
| ($ in millions) | March 31, 2024 | | December 31, 2023 |
| Finished goods | $ | 1,902 | | | $ | 1,954 | |
| Raw materials and work in process | 8,366 | | | 8,037 | |
| Supplies | 276 | | | 277 | |
| Total | 10,544 | | | 10,268 | |
| Decrease to LIFO cost | (621) | | | (562) | |
| | $ | 9,923 | | | $ | 9,706 | |
| Recognized as: | | | |
| Inventories | $ | 6,510 | | | $ | 6,358 | |
| Other Assets | 3,413 | | | 3,348 | |
Amounts recognized as Other Assets are comprised almost entirely of raw materials and work in process inventories. At both March 31, 2024 and December 31, 2023, these amounts included $2.6 billion of inventories not expected to be sold within one year. In addition, these amounts included $861 million and $790 million at March 31, 2024 and December 31, 2023, respectively, of inventories produced in preparation for product launches.
7. 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. Generally, 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
Dr. Scholl’s Foot Powder
Merck is a defendant in product liability lawsuits in the U.S. arising from consumers’ alleged exposure to talc in Dr. Scholl’s foot powder, which Merck acquired through its merger with Schering-Plough Corporation and sold as part of the divestiture of Merck’s consumer care business to Bayer in 2014. In these actions, plaintiffs allege that they were exposed to asbestos-contaminated talc and developed mesothelioma as a result. As of March 31, 2024, approximately 275 cases were pending against Merck in various state courts.
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 Vaccine, Recombinant). As of March 31, 2024, approximately 190 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 U.S. 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. In February 2024, the multidistrict litigation was reassigned to Judge Kenneth D. Bell. There are fewer than 15 product liability cases pending outside the U.S.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
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 in the first quarter of 2023. In October 2023, the court granted final approval of the indirect purchaser class settlement.
In 2020 and 2021, United Healthcare Services, Inc. (United Healthcare), Humana Inc. (Humana), Centene Corporation and others (Centene), and Kaiser Foundation Health Plan, Inc. (Kaiser) (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.
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. In December 2023, prior to a decision on the motion to dismiss, the U.S. Judicial Panel on Multidistrict Litigation remanded the four Insurer Plaintiff cases to the transferor courts in the Northern District of California (Kaiser), the District of Minnesota (United Healthcare), and the District of New Jersey (Humana and Centene). On March 15, 2024, the Merck Defendants filed motions to dismiss the Humana and Centene cases.
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 July 2023, 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 and dismissed relators’ amended complaint in full with prejudice. Relators have appealed that decision. 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 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. The Company has appealed the antitrust decision.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file abbreviated New Drug Applications (ANDAs) 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.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
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 had 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 in August 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 in December 2022 on this remaining PTE calculation defense.
As previously disclosed, in June 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 five-year extension. This ruling affirms and validates Merck’s U.S. patent protection for Bridion through at least January 2026. Also in June 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.
In July 2023, defendants filed a notice of appeal with the U.S. Court of Appeals for the Federal Circuit. The appeal is currently pending.
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 February 5, 2024, the Company received another Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Hikma Pharmaceuticals USA Inc. has filed an application to the FDA seeking pre-patent expiry approval to sell a generic version of Bridion Injection. On March 15, 2024, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Hikma, postponing FDA approval of the Hikma generic drug for 30 months or until expiration of the sugammadex patent (January 27, 2026) and any potentially applicable pediatric exclusivity or an adverse court decision, if any, whichever may occur earlier. Expiration of the patent, and any potentially applicable pediatric exclusivity, will occur earlier than expiry of the 30-month stay.
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).
As previously disclosed, beginning in 2019, a number of generic drug companies filed ANDAs seeking approval of generic forms of Januvia and Janumet along with paragraph IV certifications challenging the validity of the 2027 salt/polymorph patent. The Company responded by filing infringement suits which have all been settled. The Company has settled with a total of 26 generic companies providing that these generic companies can bring their generic versions of Januvia and Janumet to the market in the U.S. in May 2026 or earlier under certain circumstances, and their generic versions of Janumet XR to the market in July 2026 or earlier under certain circumstances.
In March 2021, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd. (collectively, Zydus). In that lawsuit, the Company alleged infringement of the 2027 salt/polymorph patent based on the filing of Zydus’s NDA seeking approval of a form of sitagliptin that is a different form than that used in Januvia. 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.
In January 2023, the Company received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Zydus filed an ANDA 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. In November 2023, the Company received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Zydus filed an ANDA seeking approval of sitagliptin/metformin HCl Extended Release tablets. In January 2024, the parties reached settlement enabling Zydus to seek final approval of a non-automatically substitutable version containing a different form of sitagliptin than that used in Janumet XR.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
As a result of these 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 in March 2023 and an Advocate General Opinion is expected in June 2024 with a decision later in 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.
In October 2023, the Company filed a patent infringement lawsuit against Sawai Pharmaceuticals Co., Ltd. and Medisa Shinyaku Co., Ltd (collectively, Defendants) in the Tokyo District Court seeking an injunction to stop the manufacture, sale and offer for sale of the Defendants’ sitagliptin dihydrogen phosphate product, while the Company’s patents and patent term extensions are in force. The lawsuit is in response to the Defendants’ application for marketing authorization to sell a generic sitagliptin dihydrogen phosphate product, in the anhydrate form, which was approved on August 15, 2023. Merck asserts that the Defendants’ activity infringes a patent term extension associated with Merck’s patent directed to the sitagliptin compound patent.
Keytruda — As previously disclosed, in November 2022, the Company filed a complaint against The Johns Hopkins University (JHU) 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 in April and May 2023, denying Merck’s claims, and counterclaiming for willful infringement of nine issued U.S. patents, including a demand for damages. Between November 30, 2023, and March 13, 2024, the Company filed inter partes review petitions with the United States Patent & Trademark Office Patent Trial and Appeal Board, challenging the validity of all nine patents asserted in the case.
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/Delaware 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.
In December 2023, AstraZeneca Pharmaceuticals LP received a second Paragraph IV Certification Letter under the Hatch-Waxman Act notifying AstraZeneca that Sandoz Inc. has filed an application to the FDA seeking pre-patent expiry approval to sell generic versions of Lynparza (olaparib) tablet. In February 2024, AstraZeneca and the Company filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Sandoz. This lawsuit, which asserts one or more patents covering olaparib, automatically stays FDA approval of the generic application until June 2026 or until an adverse court decision, if any, whichever may occur earlier.
Other Litigation
There are various other pending legal proceedings involving the Company, principally product liability and intellectual property lawsuits. While it is not feasible to predict the outcome of such proceedings, in the opinion of the Company, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to the Company’s financial condition, results of operations or cash flows either individually or in the aggregate.
Legal Defense Reserves
Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. Some of the significant factors considered in the review of these legal defense reserves are as follows: the actual costs incurred by the Company; the development of the Company’s legal defense strategy and structure in light of the scope of its litigation; the number of cases being brought against the Company; the costs and outcomes of completed trials; and the most current information regarding anticipated timing, progression, and related costs of pre-trial activities and trials in the associated litigation. The amount of legal defense reserves as of March 31, 2024 and December 31, 2023 of approximately $220 million and $210 million, respectively, represents the Company’s best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials and other events that could arise in the course of its litigation could affect the ultimate amount of legal defense costs to be incurred by the Company. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth, it believes it would be appropriate to do so.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
8. Equity
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, |
| | Common Stock | Other
Paid-In
Capital | Retained
Earnings | Accumulated
Other
Comprehensive
Loss | Treasury Stock | Non-
controlling
Interests | Total |
| ($ and shares in millions except per share amounts) | Shares | Par Value | Shares | Cost |
Balance at January 1, 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. | — | | — | | — | | 2,821 | | — | | — | | — | | — | | 2,821 | |
| Other comprehensive loss, net of taxes | — | | — | | — | | — | | (115) | | — | | — | | — | | (115) | |
Cash dividends declared on common stock ($0.73 per share) | — | | — | | — | | (1,863) | | — | | — | | — | | — | | (1,863) | |
| Treasury stock shares purchased | — | | — | | — | | — | | — | | 1 | | (149) | | — | | (149) | |
| Share-based compensation plans and other | — | | — | | 88 | | — | | — | | — | | 61 | | — | | 149 | |
| Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 4 | | 4 | |
| | | | | | | | | |
| Balance at March 31, 2023 | 3,577 | | $ | 1,788 | | $ | 44,467 | | $ | 62,039 | | $ | (4,883) | | 1,040 | | $ | (56,577) | | $ | 71 | | $ | 46,905 | |
Balance at January 1, 2024 | 3,577 | | $ | 1,788 | | $ | 44,509 | | $ | 53,895 | | $ | (5,161) | | 1,045 | | $ | (57,450) | | $ | 54 | | $ | 37,635 | |
| Net income attributable to Merck & Co., Inc. | — | | — | | — | | 4,762 | | — | | — | | — | | — | | 4,762 | |
Other comprehensive loss, net of taxes | — | | — | | — | | — | | (113) | | — | | — | | — | | (113) | |
Cash dividends declared on common stock ($0.77 per share) | — | | — | | — | | (1,960) | | — | | — | | — | | — | | (1,960) | |
| Treasury stock shares purchased | — | | — | | — | | — | | — | | 1 | | (122) | | — | | (122) | |
| Share-based compensation plans and other | — | | — | | 89 | | — | | — | | (2) | | 127 | | 1 | | 217 | |
| Net income attributable to noncontrolling interests | — | | — | | — | | — | | — | | — | | — | | 5 | | 5 | |
| | | | | | | | | |
| Balance at March 31, 2024 | 3,577 | | $ | 1,788 | | $ | 44,598 | | $ | 56,697 | | $ | (5,274) | | 1,044 | | $ | (57,445) | | $ | 60 | | $ | 40,424 | |
9. 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
March 31, | | |
| 2024 | | 2023 | | | | |
| ($ in millions) | U.S. | | International | | U.S. | | International | | | | | | | | |
| Service cost | $ | 86 | | | $ | 61 | | | $ | 76 | | | $ | 49 | | | | | | | | | |
| Interest cost | 134 | | | 74 | | | 133 | | | 74 | | | | | | | | | |
| Expected return on plan assets | (207) | | | (139) | | | (187) | | | (128) | | | | | | | | | |
Amortization of unrecognized prior service credit | — | | | (3) | | | — | | | (3) | | | | | | | | | |
Net loss (gain) amortization | 10 | | | 1 | | | — | | | (1) | | | | | | | | | |
| Termination benefits | 3 | | | — | | | — | | | — | | | | | | | | | |
| Curtailments | — | | | — | | | 2 | | | — | | | | | | | | | |
| Settlements | — | | | — | | | 21 | | | — | | | | | | | | | |
| | $ | 26 | | | $ | (6) | | | $ | 45 | | | $ | (9) | | | | | | | | | |
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
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
| Service cost | $ | 8 | | | $ | 8 | | | | | |
| Interest cost | 14 | | | 16 | | | | | |
| Expected return on plan assets | (20) | | | (16) | | | | | |
| Amortization of unrecognized prior service credit | (11) | | | (12) | | | | | |
| Net gain amortization | (12) | | | (11) | | | | | |
| | | | | | | |
| | | | | | | |
| | $ | (21) | | | $ | (15) | | | | | |
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
In connection with restructuring actions (see Note 4), termination charges were recorded on pension plans related to expanded eligibility for certain employees exiting Merck. Also, in connection with these restructuring activities, curtailments were recorded on certain pension plans. In addition, lump sum payments to U.S. pension plan participants triggered a partial settlement resulting in a charge of $21 million in the first quarter of 2023. This partial settlement triggered a remeasurement of some of the Company’s U.S. pension plans. The remeasurement, which was calculated using discount rates and asset values as of March 31, 2023, resulted in a net increase of $44 million to net pension liabilities and also resulted in a related adjustment to AOCL.
The components of net periodic benefit cost (credit) other than the service cost component are included in Other (income) expense, net (see Note 10), with the exception of certain amounts for termination benefits, curtailments and settlements, which are recorded in Restructuring costs if the event giving rise to the termination benefits, curtailment or settlement related to restructuring actions.
10. Other (Income) Expense, Net
Other (income) expense, net, consisted of:
| | | | | | | | | | | | | | | |
| | Three Months Ended
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
| Interest income | $ | (73) | | | $ | (112) | | | | | |
| Interest expense | 303 | | | 242 | | | | | |
| Exchange losses | 83 | | | 61 | | | | | |
Income from investments in equity securities, net (1) | (143) | | | (450) | | | | | |
| Net periodic defined benefit plan (credit) cost other than service cost | (160) | | | (115) | | | | | |
| Other, net | (43) | | | 463 | | | | | |
| | $ | (33) | | | $ | 89 | | | | | |
(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 three months of 2023 includes a $572.5 million charge related to settlements with certain plaintiffs in the Zetia antitrust litigation (see Note 7).
Interest paid for the three months ended March 31, 2024 and 2023 was $217 million and $208 million, respectively.
11. Income Taxes
The effective income tax rate of 15.9% for the first quarter of 2024 reflects a 1.6 percentage point unfavorable discrete impact of a charge for the acquisition of Harpoon for which no tax benefit was recognized. The effective income tax rate of 22.6% for the first quarter of 2023 reflects a 5.5 percentage point unfavorable discrete impact of a charge for the acquisition of Imago for which no tax benefit was recognized.
The Internal Revenue Service (IRS) is currently conducting examinations of the Company’s tax returns for the years 2017 and 2018, including the one-time transition tax enacted under the Tax Cuts and Jobs Act of 2017. If the IRS disagrees with the Company’s transition tax position, it may result in a significant tax liability. The statute of limitations for assessments with respect to the 2019 and 2020 federal return years will expire in June and October of 2024, respectively, unless extended.
12. Earnings Per Share
The calculations of earnings per share are as follows:
| | | | | | | | | | | | | | | |
| | Three Months Ended
March 31, | | |
| ($ and shares in millions except per share amounts) | 2024 | | 2023 | | | | |
| Net Income Attributable to Merck & Co., Inc. | $ | 4,762 | | | $ | 2,821 | | | | | |
| Average common shares outstanding | 2,533 | | | 2,538 | | | | | |
Common shares issuable (1) | 11 | | | 13 | | | | | |
| Average common shares outstanding assuming dilution | 2,544 | | | 2,551 | | | | | |
| Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders | $ | 1.88 | | | $ | 1.11 | | | | | |
| Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders | $ | 1.87 | | | $ | 1.11 | | | | | |
(1) Issuable primarily under share-based compensation plans.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
For the first quarter of 2024 and 2023, 3 million and 1 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.
13. Other Comprehensive Income (Loss)
Changes in each component of other comprehensive income (loss) are as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, |
| ($ in millions) | Derivatives | | Employee
Benefit
Plans | | Foreign Currency
Translation
Adjustment | | Accumulated Other
Comprehensive
Loss |
Balance January 1, 2023, net of taxes | $ | 73 | | | $ | (2,408) | | | $ | (2,433) | | | $ | (4,768) | |
| Other comprehensive income (loss) before reclassification adjustments, pretax | (66) | | | (47) | | | 79 | | | (34) | |
| Tax | 14 | | | 2 | | | (20) | | | (4) | |
| Other comprehensive income (loss) before reclassification adjustments, net of taxes | (52) | | | (45) | | | 59 | | | (38) | |
| Reclassification adjustments, pretax | (102) | | (1) | (7) | | (2) | 9 | | | (100) | |
| Tax | 21 | | | 2 | | | — | | | 23 | |
| Reclassification adjustments, net of taxes | (81) | |
| (5) | |
| 9 | | | (77) | |
| Other comprehensive income (loss), net of taxes | (133) | | | (50) | | | 68 | | | (115) | |
Balance March 31, 2023, net of taxes | $ | (60) | | | $ | (2,458) | | | $ | (2,365) | | | $ | (4,883) | |
Balance January 1, 2024, net of taxes | $ | (24) | | | $ | (2,793) | | | $ | (2,344) | | | $ | (5,161) | |
| Other comprehensive income (loss) before reclassification adjustments, pretax | 209 | | | 5 | | | (225) | | | (11) | |
| Tax | (44) | | | (4) | | | (13) | | | (61) | |
| Other comprehensive income (loss) before reclassification adjustments, net of taxes | 165 | | | 1 | | | (238) | | | (72) | |
| Reclassification adjustments, pretax | (44) | | (1) | (15) | | (2) | — | | | (59) | |
| Tax | 9 | | | 9 | | | — | | | 18 | |
| Reclassification adjustments, net of taxes | (35) | |
| (6) | |
| — | | | (41) | |
| Other comprehensive income (loss), net of taxes | 130 | | | (5) | | | (238) | | | (113) | |
Balance March 31, 2024, net of taxes | $ | 106 | | | $ | (2,798) | | | $ | (2,582) | | | $ | (5,274) | |
(1) Primarily relates to foreign currency cash flow hedges that were reclassified from AOCL to Sales.
(2) Includes net amortization of prior service cost, actuarial gains and losses, settlements and curtailments included in net periodic benefit cost (see Note 9).
14. 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, 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.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Sales of the Company’s products were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | |
| 2024 | | 2023 | | | | |
| ($ in millions) | U.S. | | Int’l | | Total | | U.S. | | Int’l | | Total | | | | | | | | | | | | |
| Pharmaceutical: | | | | | | | | | | | | | | | | | | | | | | | |
| Oncology | | | | | | | | | | | | | | | | | | | | | | | |
| Keytruda | $ | 4,119 | | | $ | 2,828 | | | $ | 6,947 | | | $ | 3,485 | | | $ | 2,310 | | | $ | 5,795 | | | | | | | | | | | | | |
Alliance revenue-Lynparza (1) | 135 | | | 157 | | | 292 | | | 142 | | | 133 | | | 275 | | | | | | | | | | | | | |
Alliance revenue-Lenvima (1) | 173 | | | 82 | | | 255 | | | 153 | | | 79 | | | 232 | | | | | | | | | | | | | |
| Welireg | 77 | | | 7 | | | 85 | | | 41 | | | 1 | | | 42 | | | | | | | | | | | | | |
Alliance revenue-Reblozyl (2) | 58 | | | 12 | | | 71 | | | 30 | | | 12 | | | 43 | | | | | | | | | | | | | |
| Vaccines | | | | | | | | | | | | | | | | | | | | | | | |
Gardasil/Gardasil 9 | 488 | | | 1,761 | | | 2,249 | | | 416 | | | 1,556 | | | 1,972 | | | | | | | | | | | | | |
ProQuad/M-M-R II/Varivax | 438 | | | 133 | | | 570 | | | 421 | | | 107 | | | 528 | | | | | | | | | | | | | |
| Vaxneuvance | 161 | | | 58 | | | 219 | | | 94 | | | 13 | | | 106 | | | | | | | | | | | | | |
| RotaTeq | 149 | | | 67 | | | 216 | | | 180 | | | 117 | | | 297 | | | | | | | | | | | | | |
Pneumovax 23 | 6 | | | 55 | | | 61 | | | 40 | | | 56 | | | 96 | | | | | | | | | | | | | |
| Hospital Acute Care | | | | | | | | | | | | | | | | | | | | | | | |
| Bridion | 329 | | | 111 | | | 440 | | | 276 | | | 210 | | | 487 | | | | | | | | | | | | | |
| Prevymis | 74 | | | 100 | | | 174 | | | 54 | | | 75 | | | 129 | | | | | | | | | | | | | |
| Dificid | 68 | | | 5 | | | 73 | | | 62 | | | 3 | | | 65 | | | | | | | | | | | | | |
| Zerbaxa | 33 | | | 23 | | | 56 | | | 27 | | | 23 | | | 50 | | | | | | | | | | | | | |
| Noxafil | 8 | | | 48 | | | 56 | | | 14 | | | 46 | | | 60 | | | | | | | | | | | | | |
| Cardiovascular | | | | | | | | | | | | | | | | | | | | | | | |
Alliance revenue-Adempas/Verquvo (3) | 90 | | | 8 | | | 98 | | | 83 | | | 16 | | | 99 | | | | | | | | | | | | | |
| Adempas | — | | | 70 | | | 70 | | | — | | | 59 | | | 59 | | | | | | | | | | | | | |
| Virology | | | | | | | | | | | | | | | | | | | | | | | |
| Lagevrio | 45 | | | 305 | | | 350 | | | (2) | | | 394 | | | 392 | | | | | | | | | | | | | |
Isentress/Isentress HD | 50 | | | 61 | | | 111 | | | 52 | | | 71 | | | 123 | | | | | | | | | | | | | |
Delstrigo | 12 | | | 44 | | | 56 | | | 11 | | | 33 | | | 44 | | | | | | | | | | | | | |
Pifeltro | 29 | | | 13 | | | 42 | | | 24 | | | 10 | | | 34 | | | | | | | | | | | | | |
| Neuroscience | | | | | | | | | | | | | | | | | | | | | | | |
| Belsomra | 15 | | | 32 | | | 46 | | | 16 | | | 40 | | | 56 | | | | | | | | | | | | | |
| Immunology | | | | | | | | | | | | | | | | | | | | | | | |
| Simponi | — | | | 184 | | | 184 | | | — | | | 180 | | | 180 | | | | | | | | | | | | | |
| Remicade | — | | | 39 | | | 39 | | | — | | | 51 | | | 51 | | | | | | | | | | | | | |
| Diabetes | | | | | | | | | | | | | | | | | | | | | | | |
| Januvia | 183 | | | 236 | | | 419 | | | 271 | | | 280 | | | 551 | | | | | | | | | | | | | |
| Janumet | 39 | | | 212 | | | 251 | | | 56 | | | 272 | | | 329 | | | | | | | | | | | | | |
Other pharmaceutical (4) | 157 | | | 419 | | | 576 | | | 171 | | | 457 | | | 626 | | | | | | | | | | | | | |
| Total Pharmaceutical segment sales | 6,936 | | | 7,070 | | | 14,006 | | | 6,117 | | | 6,604 | | | 12,721 | | | | | | | | | | | | | |
| Animal Health: | | | | | | | | | | | | | | | | | | | | | | | |
| Livestock | 166 | | | 683 | | | 850 | | | 174 | | | 676 | | | 849 | | | | | | | | | | | | | |
| Companion Animal | 308 | | | 354 | | | 661 | | | 308 | | | 334 | | | 642 | | | | | | | | | | | | | |
| Total Animal Health segment sales | 474 | | | 1,037 | | | 1,511 | | | 482 | | | 1,010 | | | 1,491 | | | | | | | | | | | | | |
| Total segment sales | 7,410 | | | 8,107 | | | 15,517 | | | 6,599 | | | 7,614 | | | 14,212 | | | | | | | | | | | | | |
Other (5) | 68 | | | 190 | | | 258 | | | 60 | | | 214 | | | 275 | | | | | | | | | | | | | |
| | $ | 7,478 | | | $ | 8,297 | | | $ | 15,775 | | | $ | 6,659 | | | $ | 7,828 | | | $ | 14,487 | | | | | | | | | | | | | |
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 (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 $54 million and $99 million for the three months ended March 31, 2024 and 2023, respectively, as well as revenue from third-party manufacturing arrangements (including sales to Organon). Other for the three months ended March 31, 2024 and 2023 also includes $61 million and $51 million, respectively, related to upfront and milestone payments received by Merck for out-licensing arrangements.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Product sales are recorded net of the provision for discounts, including chargebacks, which are customer discounts that occur when a contracted customer purchases through an intermediary wholesale purchaser, and rebates that are owed based upon definitive contractual agreements or legal requirements with private sector and public sector (Medicaid and Medicare Part D) benefit providers, after the final dispensing of the product by a pharmacy to a benefit plan participant. These discounts, in the aggregate, reduced U.S. sales by $3.2 billion and $3.1 billion for the three months ended March 31, 2024 and 2023, respectively.
Consolidated sales by geographic area where derived are as follows:
| | | | | | | | | | | | | | | |
| Three Months Ended
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
| United States | $ | 7,478 | | | $ | 6,659 | | | | | |
| Europe, Middle East and Africa | 3,563 | | | 3,303 | | | | | |
| China | 1,772 | | | 1,715 | | | | | |
| Japan | 821 | | | 758 | | | | | |
| Latin America | 796 | | | 661 | | | | | |
| Asia Pacific (other than China and Japan) | 724 | | | 846 | | | | | |
| Other | 621 | | | 545 | | | | | |
| | $ | 15,775 | | | $ | 14,487 | | | | | |
A reconciliation of segment profits to Income Before Taxes is as follows:
| | | | | | | | | | | | | | | |
| | Three Months Ended
March 31, | | |
| ($ in millions) | 2024 | | 2023 | | | | |
| Segment profits: | | | | | | | |
| Pharmaceutical segment | $ | 10,904 | | | $ | 9,140 | | | | | |
| Animal Health segment | 555 | | | 566 | | | | | |
| Total segment profits | 11,459 | | | 9,706 | | | | | |
| Other profits | 146 | | | 164 | | | | | |
| Unallocated: | | | | | | | |
| Interest income | 73 | | | 112 | | | | | |
| Interest expense | (303) | | | (242) | | | | | |
| Amortization | (473) | | | (543) | | | | | |
| Depreciation | (452) | | | (398) | | | | | |
| Research and development | (3,851) | | | (4,147) | | | | | |
| Restructuring costs | (123) | | | (67) | | | | | |
| Charge for Zetia antitrust litigation settlements | — | | | (573) | | | | | |
| Other unallocated, net | (806) | | | (362) | | | | | |
| | $ | 5,670 | | | $ | 3,650 | | | | | |
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 by Merck Research Laboratories, the Company’s research and development division that focuses on human health-related activities, or general and administrative expenses not directly incurred by the segments, 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 amortization of purchase accounting adjustments are not allocated to segments.
Other profits are primarily comprised of miscellaneous corporate profits, as well as operating profits (losses) 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.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)