Sitagliptin Phosphate/Metformin Hydrochloride

iStock, photoschmidt Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of the industry’s top-performers are losing key market protections. Some companies are more prepared than others. Biopharma is being battered by patent headwinds that are the strongest they’ve been in nearly 15 years. That’s according to a report last month from analyst firm William Blair, which estimates that from 2023 through the end of 2025, nearly 50 products will have lost patent protections—in turn eroding the aggregate sales of these drugs from $162.8 billion in 2025 to just $67 billion in 2029. “We believe the biggest headwind to large pharma revenue growth over the next five years is loss of exclusivity,” William Blair analysts wrote in the report. The patent cliff is exactly that: a cliff. Take AbbVie’s Humira, for instance. The immunology juggernaut is one of the most high-pro to go off patent in recent years after topping the list of pharma’s highest selling drugs for much of its blissful patent-protected period. AbbVie recorded sales of $21.24 billion in 2022. The year after, sales were $14.04 billion and last year just $8.99 billion. To patch the hole, AbbVie has leaned on its new immunology stars, Skyrizi and Rinvoq, which brought in $11.72 billion and $5.97 billion globally in 2024, respectively. Five industry powerhouses will see the same challenge in the coming years, as potential biosimilar and generic competition threaten sales. According to William Blair, the loss will affect assets that accounted for more than 30% of the collective revenues from Bristol Myers Squibb, Pfizer, AstraZeneca, Novartis and Regeneron in 2024. In this article, BioSpace looks at five pharma players—and one honorable mention—facing the greatest loss of sales in the coming years and how they’re planning to replace the revenue. Merck Set to Lose Exclusivity for Keytruda, Seminal PD-1 Inhibitor Assets at risk : Lenvima (2025), Januvia and Janumet (2026), Lynparza (2027), Gardasil/Gardasil 9 (2028) and Keytruda (2028) Perhaps the most talked about patent cliff belongs to Merck’s blockbuster cancer therapy Keytruda, one of the industry’s highest-earning assets with more than $29 billion in sales last year. Keytruda faces a key patent expiry in 2028. To help shore up the drug’s sales, Merck is gearing up for regulatory discussions about its subcutaneous formulation of the PD-1 blocker. If successful, the product’s launch could lessen the grade of the patent cliff the company inevitably faces. Aside from subcutaneous Keytruda, Merck is leaning on its pulmonary hypertension therapy Winrevair, which according to William Blair will be the pharma’s “main driver of growth,” expecting $4.9 billion in sales in 2029. Other Merck assets set to encounter patent headwinds in the coming years include the cancer drug Lenvima later this year, Gardasil/Gardasil 9 in 2028, the diabetes drugs Januvia and Janumet in 2026 and the cancer therapy Lynparza in 2027. Bristol Myers Squibb Cuts Costs and Jobs in Face of Three Impending Cliffs Assets at risk : Yervoy (2025), Eliquis (2026) and Opdivo (2028) As in the case of Regeneron, BMS is set to lose key protections for one its most valuable assets. Eliquis, an anticoagulant for the prevention of stroke, made over $13 billion in 2024. Ahead of the loss of exclusivity in 2026, several generics have already secured the FDA’s approval. These include copycats from Mylan Pharmaceuticals and Micro Labs Limited, which the FDA greenlit in December 2019 . BMS and its partner Pfizer have put up a strong legal effort to stall these generics, securing a critical court win in August 2020 that would let them keep the market to themselves until 2026. Still, the pressure is on for BMS to find alternative sources of revenue, especially because its cancer therapy Yervoy faces loss of exclusivity even sooner—this year. Yervoy brought in $2.5 billion for the pharma in 2024. According to William Blair, BMS is unprepared for the cliffs its facing, “despite several recent notable acquisitions, there is not much to get excited about in Bristol Myers’ late-stage pipeline,” the firm wrote. BMS’s most standout asset is the PD-1 blocker Opdivo, which likewise faces key expiries in 2028, though a recently approved subcutaneous formulation could help buoy growth through this point and beyond. Instead of beefing up its pipeline, BMS has chosen to weather the storm with cost-cuts. In April 2024, the pharma kicked off a sweeping realignment program —which includes around 2,200 layoffs—with an eye toward saving up to $1.5 billion through 2025. In its full-year 2024 business report earlier this month, the company tacked another $2 billion to the cost-cutting goal, which it hopes to realize through 2027. Eliquis Tops Pfizer’s List of Patent Problems Asset at risk : Prevnar (2026), Ibrance (2027), Xtandi (2027) and Eliquis (2028) Eliquis’ loss of exclusivity could be even more painful for Pfizer , the prospects of which William Blair called “bleak” in its report. In 2024, Eliquis emerged as Pfizer’s top-performing asset, growing 10% year-on-year operationally to bring in $7.4 billion . But the product faces loss of exclusivity in April 2028, with several generics waiting to eat into its sales. Compounding the company’s revenue problem is the fact that Eliquis was named among the first 10 drugs subject to price negotiations with the Centers for Medicare & Medicaid Services (CMS) prescribed by the Inflation Reduction Act (IRA), with the discounted negotiated price to go into effect in 2026. Pfizer has several other assets that are set to lose key patent protections in the coming years, too, including the pneumonia shot Prevnar in 2026 and the cancer drugs Ibrance and Xtandi, both in 2027. Erosion in sales is just one of Pfizer’s problems, which also include an activist investor jockeying for control and an unreliable COVID-19 market dynamics. There’s also what William Blair called an “underwhelming legacy pipeline.” Seemingly aware of its precarious position, Pfizer sought to shore up its bottom line with an aggressive and sweeping cost-cutting measure. The savings program announced in October 2023 was designed to help the company lower its spend by $3.5 billion last year, while a more recent round in May 2024 set a $1.7 billion savings target by the end of 2027. Aside from cost-cuts, the pharma is also banking on several 2025 catalysts—including up to four regulatory decisions—that could position the pharma for better growth in coming years, according to its fourth-quarter business report . Commercially, Pfizer is leaning heavily on its antibody-drug conjugate Padcev, which CEO Albert Bourla told investors was “an important growth driver.” The company is expecting additional data for Padcev later this year that could open a path for approval in muscle-invasive bladder cancer. If approved, that indication “would nearly triple the total addressable patients in the U.S.,” Bourla said. AstraZeneca’s Plan for Reaching $80B in Revenue Despite Expiries Asset at risk : Farxiga (2025), Soliris (2025) In May 2024, AstraZeneca unveiled an ambitious plan to deliver $80 billion in total annual revenue by 2030—a goal that could be crippled when Farxiga loses key patent protections later this year. In 2024, the drug brought in $7.7 billion , corresponding to 31% year-on-year growth at constant currencies. Soliris, a key rare disease asset that brought in nearly $2.6 billion in 2024, is also facing loss of exclusivity and is expected to face biosimilar challenge this year. Still, the pharma appears well-positioned to hit its 2030 target. As per William Blair, AstraZeneca has done a “commendable job” of building out its product portfolio, particularly in the oncology space. Enhertu, a Daiichi Sankyo-partnered antibody-drug conjugate (ADC), recently won broad approval in breast cancer. Enhertu will retain crucial patent protections past 2030, according to William Blair. Other cancer standouts include Tagrisso and Imfinzi, which respectively made $6.58 billion and $4.72 billion in 2024. AstraZeneca also boasts its clinical pipeline, which could bear fruit in the near-future. In a media call ahead for the pharma’s fourth-quarter earnings report, Chief Finance Officer Aradhana Sarin called 2025 an “unprecedented catalyst-rich period” for AstraZeneca. In particular, the company is awaiting key readouts for several of its products, including not only Enhertu and Imfinzi but also the recently approved Datroway and asthma treatment Fasenra. AstraZeneca is also expecting crucial data for new assets such as camizestrant for different cancers and baxdrostat for hypertension. “The value of our pipeline has been increasing, and now we have more than 90 late-stage studies underway, with an average peak-year revenue potential of over $1 billion,” Sarin said. Novartis Struggles to Maintain Entresto’s Exclusivity Assets at risk : Entresto (2025), Xolair (2025), Jakafi (2026), Cosentyx (2029) and Tafinlar (2030) Novartis ’ patent problems escalated in 2024. The heart failure drug Entresto, which made $7.8 billion last year, is set to lose market exclusivity in July 2025 . The pharma started efforts to guard its place in the market as early as September 2022, when it filed a citizen Pptition to the FDA asking the regulator not to approve drug applications referencing Entresto and specific patents related to it. But last July, the FDA denied the petition, noting that it is possible for generic drugs to sidestep Entresto’s patents with labeling tweaks. The same month, the FDA signed off on MSN Pharmaceuticals’ generic version of Entresto. Those decisions have since opened a legal saga for Novartis, which most recently secured a last-minute stay against MSN’s copycat, preventing its market entry while the pharma’s patent complaint remains open. In its fourth-quarter and full-year 2024 earnings call last month, company executives expressed confidence that Novartis would be able to smoothly weather Entresto’s loss of exclusivity in mid-2025. The company expects to “secure pediatric exclusivity” for Entresto, which could potentially help soften the blow of generics this year, CEO Vas Narasimhan said during the call. Aside from the heart failure drug, Novartis is also facing down patent expirations for Xolair in 2025, Jakafi in 2026, Cosentyx in 2029 and Tafinlar in 2030. Ilaris, indicated for auto-inflammatory diseases, lost key protections last year, while chronic myeloid leukemia drug Tasigna became open to generic erosion in 2023. Much of Novartis’ resilience through the patent expiries will come from fiscal discipline, Chief Financial Officer Harry Kirsch explained during the call. Honorable Mention: Regeneron’s High-Dose Eylea Not Making Up for LOE Asset at risk : Eylea (2024) Regeneron is already in the throes of a major patent expiry for its blockbuster eye disease drug Eylea, which in 2024 was the pharma’s top-performing asset with $5.97 billion in sales in the U.S. But last May, the company lost key protections for the drug, thereby opening it up to considerable copycat competition. And of these, there are several. The same month Eylea went off patent, the FDA signed off on two interchangeable biosimilars, Biocon Biologics’ Yesafili and Samsung Bioepis and Biogen’s Opuviz. A few months later, Novartis spinoff Sandoz also won the regulator’s go-ahead for its own biosimilar called Enzeevu. To help protect Eylea’s place in the market, Regeneron has taken many of its competitors to court. In December 2023, the pharma sued Samsung Bio for alleged patent infringement. Regeneron also has a case against Sandoz, seeking to block the generics developer from marketing its biosimilar. The pharma has also developed a high-dose (HD) version of Eylea to keep the product’s competitive edge. The product earned the FDA greenlight in August 2023, but uptake has been slow. In the fourth quarter of 2024, Eylea HD’s sales came in at $305 million, below analyst expectations of $336 million. In the pharma’s earnings call, CEO Leonard Schleifer urged investors to “look beyond” its Eylea franchise, noting that “our strategy is not to be solely dependent on any one thing.” In 2025, Regeneron is looking forward to the launch of its anti-IL-4/IL-13 antibody Dupixent in chronic obstructive pulmonary disease, as well as several key data readouts.

RAHWAY, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter of 2024. “ We delivered strong growth in 2024, reflecting demand for our innovative portfolio, including for KEYTRUDA, which continues to benefit more patients with cancer globally, the successful launch of WINREVAIR and strong performance of our Animal Health business,” said Robert M. Davis, chairman and chief executive officer, Merck. " We’re continuing to progress our pipeline, advance key clinical programs and augment our pipeline through promising business development. Our business remains well positioned thanks to the dedication of our talented global team, and I am more confident than ever in our long-term growth potential.” Financial Summary $ in millions, except EPS amounts Fourth Quarter Year Ended 2024 2023 Change Change Ex-Exchange Dec. 31, 2024 Dec. 31, 2023 Change Change Ex-Exchange Sales $15,624 $14,630 7% 9% $64,168 $60,115 7% 10% GAAP net income (loss) 1 3,743 (1,226) N/M N/M 17,117 365 N/M N/M Non-GAAP net income that excludes certain items 1,2* 4,372 66 N/M N/M 19,444 3,837 N/M N/M GAAP EPS 1.48 (0.48) N/M N/M 6.74 0.14 N/M N/M Non-GAAP EPS that excludes certain items 2* 1.72 0.03 N/M N/M 7.65 1.51 N/M N/M *Refer to table on page 9. N/M - not meaningful Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.48 for the fourth quarter and $6.74 for the full year of 2024. Non-GAAP EPS was $1.72 for the fourth quarter and $7.65 for the full year of 2024. GAAP and non-GAAP EPS in the fourth quarter of 2024 include a charge of $0.23 per share related to the execution of licensing agreements with LaNova Medicines Ltd. (LaNova) and Hansoh Pharma (Hansoh). GAAP loss per share and non-GAAP EPS in the fourth quarter of 2023 include a charge of $1.69 per share related to a collaboration with Daiichi Sankyo. GAAP and non-GAAP EPS for the full years of 2024 and 2023 include charges of $1.28 and $6.21 per share, respectively, related to certain collaborations, licensing agreements and asset acquisitions. Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in the fourth quarter and full year of 2024 also exclude a benefit due to a reduction in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years. Non-GAAP EPS for the full year of 2023 also excludes a charge related to settlements with certain plaintiffs in the Zetia antitrust litigation. Fourth-Quarter Sales Performance The following table reflects sales of the company’s top products and significant performance drivers. Fourth Quarter $ in millions 2024 2023 Change Change Ex-Exchange Commentary Total Sales $15,624 $14,630 7% 9% The negative impact of foreign exchange was primarily due to devaluation of Argentine peso, which was largely offset by inflation-related price increases, consistent with practice in that market. Pharmaceutical 14,042 13,141 7% 8% Increase driven by growth in oncology and cardiovascular, partially offset by declines in diabetes, vaccines, immunology and virology. KEYTRUDA 7,836 6,608 19% 21% Growth driven by continued strong global demand from metastatic indications, including increased uptake in bladder and endometrial cancers, as well as increased global uptake in earlier-stage indications, including triple-negative breast cancer and non-small cell lung cancer (NSCLC). The negative impact of foreign exchange was primarily due to devaluation of Argentine peso, which was largely offset by inflation-related price increases. GARDASIL/GARDASIL 9 1,550 1,871 -17% -18% Decline primarily due to lower demand in China, partially offset by higher demand in most international regions, particularly in Japan. PROQUAD, M-M-R II and VARIVAX 594 545 9% 9% Growth primarily due to higher pricing in the U.S. and higher tenders in certain international markets, partially offset by lower demand in the U.S. JANUVIA/JANUMET 487 787 -38% -36% Decline primarily due to lower pricing in the U.S., as well as ongoing generic competition in many international markets and supply constraints in China. BRIDION 449 429 5% 5% Growth primarily due to higher demand in the U.S., partially offset by generic competition in certain international markets, particularly in Japan and Europe. Lynparza* 365 315 16% 18% Growth primarily due to higher global demand. Lenvima* 255 226 13% 14% Growth primarily due to timing of shipments in certain international markets. PREVYMIS 215 175 23% 23% Growth primarily due to higher demand in most markets, particularly in the U.S. WINREVAIR 200 - - - Represents continued uptake since second-quarter launch in the U.S. VAXNEUVANCE 161 176 -9% -9% Decline primarily driven by lower demand in the U.S. due to competition, partially offset by continued uptake from launches in Europe and the Asia Pacific region. WELIREG 160 72 122% 123% Growth primarily driven by higher demand in the U.S., largely attributable to ongoing uptake of a new indication. SIMPONI - 171 N/M N/M Marketing rights in former Merck territories reverted to Johnson & Johnson on Oct. 1, 2024. Animal Health 1,397 1,278 9% 13% Growth primarily driven by higher pricing for both Livestock and Companion Animal product portfolios, as well as sales related to July 2024 acquisition of Elanco aqua business and higher demand for Livestock products. Approximately 3 percentage points of the negative impact of foreign exchange were due to devaluation of Argentine peso, which were largely offset by inflation-related price increases. Livestock 889 808 10% 14% Growth primarily driven by higher demand for poultry products, sales related to acquisition of Elanco aqua business, as well as higher pricing across the portfolio. Companion Animal 508 470 8% 10% Growth primarily driven by higher pricing across the product portfolio. Sales of BRAVECTO were $209 million and $197 million in current and prior year quarters, respectively, which represented growth of 6%, or 10% excluding impact of foreign exchange. Other Revenues** 185 211 -13% 3% Decline primarily due to impact of revenue-hedging activities and lower revenues from third-party manufacturing arrangements, partially offset by payments received for out-licensing arrangements and higher royalty income. *Alliance revenue for this product represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs. **Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. N/M – not meaningful Full-Year Sales Performance The following table reflects sales of the company’s top products and significant performance drivers. Year Ended $ in millions Dec. 31, 2024 Dec. 31, 2023 Change Change Ex- Exchange Total Sales $64,168 $60,115 7% 10% Pharmaceutical 57,400 53,583 7% 10% KEYTRUDA 29,482 25,011 18% 22% GARDASIL/GARDASIL 9 8,583 8,886 -3% -2% PROQUAD, M-M-R II and VARIVAX 2,485 2,368 5% 5% JANUVIA/JANUMET 2,268 3,366 -33% -29% BRIDION 1,764 1,842 -4% -3% Lynparza* 1,311 1,199 9% 11% Lenvima* 1,010 960 5% 6% LAGEVRIO 964 1,428 -33% -28% VAXNEUVANCE 808 665 22% 23% PREVYMIS 785 605 30% 33% ROTATEQ 711 769 -8% -7% SIMPONI** 543 710 -24% -23% WELIREG 509 218 133% 133% WINREVAIR 419 - - - Animal Health 5,877 5,625 4% 8% Livestock 3,462 3,337 4% 9% Companion Animal 2,415 2,288 6% 7% Other Revenues*** 891 907 -2% 4% *Alliance revenue for this product represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs. **Marketing rights in former Merck territories reverted to Johnson & Johnson on Oct. 1, 2024. ***Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Full-year 2024 pharmaceutical sales grew 7% to $57.4 billion. Excluding the unfavorable impact of foreign exchange, pharmaceutical sales grew 10%. Approximately 2 percentage points of the negative impact of foreign exchange were due to devaluation of the Argentine peso, which were largely offset by inflation-related price increases, consistent with practice in that market. Pharmaceutical sales growth was primarily driven by higher sales in oncology, particularly KEYTRUDA and WELIREG, as well as increased alliance revenue from Reblozyl and Lynparza. Higher sales in the cardiovascular franchise, reflecting the successful launch of WINREVAIR, as well as higher sales of certain hospital acute care products, particularly PREVYMIS, also drove revenue growth in 2024. Pharmaceutical sales growth in 2024 was partially offset by lower sales of JANUVIA and JANUMET, primarily reflecting lower pricing in the U.S. and generic competition in many international markets, lower sales of the COVID-19 medication LAGEVRIO, lower sales of GARDASIL/GARDASIL 9 and lower sales of SIMPONI and REMICADE, reflecting the transfer of marketing rights in former Merck territories back to Johnson & Johnson. Full-year 2024 Animal Health sales grew 4% to $5.9 billion. Excluding the unfavorable impact of foreign exchange, Animal Health sales grew 8%. Approximately 2 percentage points of the negative impact of foreign exchange were due to devaluation of the Argentine peso, which were largely offset by inflation-related price increases, consistent with practice in that market. Full-year sales growth was primarily driven by higher pricing across both the Companion Animal and Livestock product portfolios, and higher demand for poultry and swine products, as well as sales related to the acquisition of the Elanco aqua business. Sales of BRAVECTO were $1.1 billion in 2024, which represented growth of 6%, or 8% excluding the impact of foreign exchange. Fourth-Quarter and Full-Year Expense, EPS and Related Information The table below presents selected expense information. $ in millions GAAP Acquisition- and Divestiture- Related Costs 3 Restructuring Costs (Income) Loss From Investments in Equity Securities Non- GAAP 2 Fourth Quarter 2024 Cost of sales $3,828 $701 $121 $- $3,006 Selling, general and administrative 2,864 29 16 - 2,819 Research and development 4,585 12 (1) - 4,574 Restructuring costs 51 - 51 - - Other (income) expense, net 126 (31) - 152 5 Fourth Quarter 2023 Cost of sales $3,911 $454 $117 $- $3,340 Selling, general and administrative 2,804 24 29 - 2,751 Research and development 9,628 790 - - 8,838 Restructuring costs 255 - 255 - - Other (income) expense, net 78 (35) - (61) 174 $ in millions GAAP Acquisition- and Divestiture- Related Costs 3 Restructuring Costs (Income) Loss From Investments in Equity Securities Certain Other Items Non- GAAP 2 Year Ended December 31, 2024 Cost of sales $15,193 $2,409 $495 $- $ - $12,289 Selling, general and administrative 10,816 117 83 - - 10,616 Research and development 17,938 72 1 - - 17,865 Restructuring costs 309 - 309 - - - Other (income) expense, net (24) (79) - 45 - 10 Year Ended December 31, 2023 Cost of sales $16,126 $2,018 $211 $- $- $13,897 Selling, general and administrative 10,504 86 122 - - 10,296 Research and development 30,531 819 1 - - 29,711 Restructuring costs 599 - 599 - - - Other (income) expense, net 466 (47) - (279) 573 219 GAAP Expense, EPS and Related Information Gross margin was 75.5% for the fourth quarter of 2024 compared with 73.3% for the fourth quarter of 2023. The increase was primarily due to the favorable effects of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher manufacturing-related costs (including inventory write-offs) and higher amortization of intangible assets. Gross margin was 76.3% for the full year of 2024 compared with 73.2% for the full year of 2023. The increase was primarily due to the favorable effects of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher amortization of intangible assets, as well as higher restructuring costs (primarily reflecting asset impairment charges) and higher manufacturing-related costs (including inventory write-offs). Selling, general and administrative (SG&A) expenses were $2.9 billion in the fourth quarter of 2024, an increase of 2% compared with the fourth quarter of 2023. The increase was primarily due to higher promotional and selling costs, partially offset by the favorable impact of foreign exchange and lower restructuring costs. Full-year 2024 SG&A expenses were $10.8 billion, an increase of 3% compared with full-year 2023. The increase was primarily due to higher administrative, promotional, selling and acquisition-related costs, partially offset by the favorable impact of foreign exchange and lower restructuring costs. Research and development (R&D) expenses were $4.6 billion in the fourth quarter of 2024, a decrease of 52% compared with the fourth quarter of 2023. R&D expenses were $17.9 billion for the full year of 2024, a decrease of 41% compared with the full year of 2023. The declines in both the fourth quarter and full year of 2024 were primarily due to lower charges for business development activity, lower intangible asset impairment charges, and the favorable impact of foreign exchange, partially offset by increased compensation and benefit costs and higher clinical development spending. Other (income) expense, net, was $126 million of expense in the fourth quarter of 2024 compared with $78 million of expense in the fourth quarter of 2023. The unfavorability was primarily due to net losses from investments in equity securities compared with net income from investments in equity securities in the prior year quarter, partially offset by lower foreign exchange losses and lower net interest expense. Other (income) expense, net, was $24 million of income in the full year of 2024 compared with $466 million of expense in the full year of 2023, primarily due to a $572.5 million charge in 2023 related to settlements with certain plaintiffs in the Zetia antitrust litigation. The favorability was also due to $170 million of income related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as lower foreign exchange losses in 2024. Other (income) expense, net, in the full year of 2024 was unfavorably affected by lower net income from investments in equity securities and higher net interest expense compared with 2023. The effective tax rates of 10.2% and 14.1% for the fourth quarter and full year of 2024, respectively, include a 6.2 percentage point favorable impact and a 2.6 percentage point favorable impact, respectively, due to a reduction in reserves for unrecognized income tax benefits, resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years. GAAP EPS was $1.48 for the fourth quarter of 2024 compared with a loss per share of $0.48 for the fourth quarter of 2023, primarily driven by lower charges for business development transactions, operational strength in the business, lower intangible asset impairment charges, and a benefit from the expiration of the statute of limitations for assessments related to the 2020 federal tax return year. GAAP EPS was $6.74 for the full year of 2024 compared with EPS of $0.14 for the full year of 2023. The increase was primarily driven by lower charges for business development transactions, operational strength in the business, lower intangible asset impairment charges, a benefit from the expiration of the statute of limitations for the 2020 and 2019 federal tax return years, and a charge in the prior year for settlements with certain plaintiffs in the Zetia antitrust litigation, partially offset by the unfavorable effect of foreign exchange. Non-GAAP Expense, EPS and Related Information Non-GAAP gross margin was 80.8% for the fourth quarter of 2024 compared with 77.2% for the fourth quarter of 2023. Non-GAAP gross margin was 80.8% for the full year of 2024 compared with 76.9% for the full year of 2023. The non-GAAP gross margin improvements in both the fourth quarter and full year of 2024 were primarily due to the favorable effects of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher manufacturing-related costs (including inventory write-offs). Non-GAAP SG&A expenses were $2.8 billion in the fourth quarter of 2024, an increase of 2% compared with the fourth quarter of 2023. Non-GAAP SG&A expenses were $10.6 billion for the full year of 2024, an increase of 3% compared with the full year of 2023. The increases were primarily due to higher promotional and selling costs and, for the full year, higher administrative costs, partially offset by the favorable impact of foreign exchange. Non-GAAP R&D expenses were $4.6 billion in the fourth quarter of 2024, a decrease of 48% compared with the fourth quarter of 2023. Non-GAAP R&D expenses were $17.9 billion for the full year of 2024, a decrease of 40% compared with the full year of 2023. The declines in both the fourth quarter and full year of 2024 were primarily due to lower charges for business development activity and the favorable impact of foreign exchange, partially offset by increased compensation and benefit costs and higher clinical development spending. Non-GAAP other (income) expense, net, was $5 million of expense in the fourth quarter of 2024 compared with $174 million of expense in the fourth quarter of 2023. The favorability was primarily due to lower foreign exchange losses and lower net interest expense. Non-GAAP other (income) expense, net, was $10 million of expense in the full year of 2024 compared with $219 million of expense in the full year of 2023. The favorability was primarily due to $170 million of income related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as lower foreign exchange losses in 2024, partially offset by higher net interest expense. The non-GAAP effective tax rate was 16.2% for the fourth quarter and 16.8% for the full year of 2024. Non-GAAP EPS was $1.72 for the fourth quarter of 2024 compared with $0.03 for the fourth quarter of 2023. Non-GAAP EPS was $7.65 for the full year of 2024 compared with EPS of $1.51 for the full year of 2023. The increase in both periods was primarily driven by lower charges for business development transactions and operational strength in the business. The unfavorable effect of foreign exchange partially offset the increase in the full year. A reconciliation of GAAP to non-GAAP net income (loss) and earnings (loss) per share is provided in the table that follows. Fourth Quarter Year Ended $ in millions, except EPS amounts 2024 2023 Dec. 31, 2024 Dec. 31, 2023 EPS GAAP EPS $1.48 $(0.48) $6.74 $0.14 Difference 0.24 0.51 0.91 1.37 Non-GAAP EPS that excludes items listed below 2 $1.72 $0.03 $7.65 $1.51 Net Income (Loss) GAAP net income (loss) 1 $3,743 $(1,226) $17,117 $365 Difference 629 1,292 2,327 3,472 Non-GAAP net income that excludes items listed below 1,2 $4,372 $66 $19,444 $3,837 Excluded Items: Acquisition- and divestiture-related costs 3 $711 $1,233 $2,519 $2,876 Restructuring costs 187 401 888 933 Loss (income) from investments in equity securities 152 (61) 45 (279) Charge for Zetia antitrust litigation settlements - - - 573 Decrease to net income/increase to net loss before taxes 1,050 1,573 3,452 4,103 Estimated income tax (benefit) expense 4 (421) (281) (1,125) (631) Decrease to net income/increase to net loss $629 $1,292 $2,327 $3,472 Pipeline and Portfolio Highlights Merck made important advancements in its broad, diverse pipeline, meeting significant regulatory and clinical milestones throughout the fourth quarter. In oncology, Merck announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial evaluating the noninferiority of subcutaneous pembrolizumab and berahyaluronidase alfa, in combination with chemotherapy, versus intravenous (IV) KEYTRUDA administered with chemotherapy, for the first-line treatment of adult patients with metastatic NSCLC. Subcutaneous pembrolizumab and berahyaluronidase alfa has the potential to improve the patient experience and increase access for patients and health care providers compared to IV administration. Merck presented new data across multiple hematologic malignancies at the American Society of Hematology Annual Meeting and Exposition in December 2024, including promising Phase 2 data for its investigational antibody-drug conjugate zilovertamab vedotin for the treatment of patients with previously untreated diffuse large B-cell lymphoma. With more than 20 abstracts presented, the data showcased Merck’s continued progress in advancing clinical research for its expanding and diverse hematology pipeline. Merck also achieved several key regulatory milestones in the U.S., Europe, Japan and China. Highlights include the U.S. Food and Drug Administration (FDA) granting Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of certain patients with previously treated advanced or metastatic nonsquamous NSCLC with epidermal growth factor receptor (EGFR) mutations. Additionally, Merck received new approvals for KEYTRUDA-based regimens in Japan and China, as well as for WELIREG and Lynparza in China. In vaccines and infectious diseases, the FDA accepted the Biologics License Application (BLA) for clesrovimab, an investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season and set a Prescription Drug User Fee Act (PDUFA) date of June 10, 2025. This regulatory milestone marks important progress toward having clesrovimab available in time for the 2025-26 RSV season. The filing was based on results from the pivotal Phase 2b/3 study of clesrovimab in infants for the prevention of RSV that was presented at ID Week 2024. In addition, Merck announced topline results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) in adults with virologically suppressed HIV-1 infection, in line with Merck’s commitment to help address the needs of people living with HIV. In January 2025, Merck also received expanded approval in China for GARDASIL. It is now the first HPV vaccine approved in China for the prevention of certain HPV-related cancers and diseases in males 9-26 years of age. In addition, the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of CAPVAXIVE for pneumococcal vaccination in adults, with a final decision for EU approval expected in the second quarter of 2025. In cardiovascular disease, Merck announced positive topline results from the Phase 3 ZENITH study, evaluating WINREVAIR in adults with pulmonary arterial hypertension (PAH) with World Health Organization (WHO) Group 1 functional class (FC) III or IV at high risk of mortality. Based on the positive results of an interim analysis, an independent data monitoring committee recommended that the study be stopped early due to overwhelming efficacy. In addition, in January 2025, Merck announced the Phase 3 HYPERION study evaluating WINREVAIR in newly diagnosed adults with PAH with FC II or III at intermediate or high risk of disease progression was also stopped early based on the positive results from the interim analysis of the ZENITH trial and a review of the totality of data from the WINREVAIR clinical program to date. All participants in both the ZENITH and HYPERION studies will be offered the opportunity to receive WINREVAIR as part of the open-label, long-term extension study, SOTERIA. Merck continued to execute on its business development strategy. The company announced the closing of an exclusive global license for MK-2010, a novel investigational PD-1/VEGF bispecific antibody from LaNova. Merck also entered into an exclusive global license agreement with Hansoh to evaluate MK-4082, an investigational preclinical oral small molecule glucagon-like peptide (GLP-1) receptor agonist. Notable recent news releases on Merck’s pipeline and portfolio are provided in the table that follows. Oncology FDA Granted Breakthrough Therapy Designation to sac-TMT for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous NSCLC With EGFR Mutations (Read Announcement) FDA Granted Priority Review to Merck’s Application for WELIREG for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma (Read Announcement) Merck Received Positive EU CHMP Opinion for WELIREG as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced RCC, Based on Results From Phase 2 LITESPARK-004 and Phase 3 LITESPARK-005 Trials (Read Announcement) Merck Received Positive EU CHMP Opinion for KEYTRUDA Plus Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Non-Epithelioid Malignant Pleural Mesothelioma, Based on Results From Phase 2/3 IND.227/KEYNOTE-483 Trial (Read Announcement) KEYTRUDA Approved in China in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy After Surgery as Adjuvant Treatment for Patients With Resectable Stage II, IIIA or IIIB NSCLC, Based on Results From Phase 3 KEYNOTE-671 Trial (Read Announcement) WELIREG Approved in China for Treatment of Adult Patients With Certain Types of VHL Disease-Associated Tumors, Based on Results From Phase 2 LITESPARK-004 Trial (Read Announcement) Merck Announced Phase 3 MK-3475A-D77 Trial of Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Met Primary Endpoints (Read Announcement) Merck Announced Phase 3 KEYLYNK-001 Trial Met Primary Endpoint of Progression-Free Survival in Patients With Advanced Epithelial Ovarian Cancer (Read Announcement) Lynparza Demonstrated Clinically Meaningful Prolonged Survival Benefit in Early Breast Cancer, Based on Results From Phase 3 OlympiA Trial (Read Announcement) Investigational Zilovertamab Vedotin in Combination With R-CHP Demonstrated Complete Response Rate of 100% at 1.75 MG/KG Dose in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma, Based on Results From Phase 2 WaveLINE-007 Trial (Read Announcement) Vaccines Merck Announced FDA Acceptance of BLA for Clesrovimab (MK-1654), an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants From RSV Disease During Their First RSV Season; FDA Set PDUFA Date of June 10, 2025 (Read Announcement) Merck Received Expanded Approval of GARDASIL for Males in China (Read Announcement) Merck Received Positive EU CHMP Opinion for CAPVAXIVE for Pneumococcal Vaccination in Adults (Read Announcement) Merck Presented New Data From GARDASIL 9 Studies Reinforcing Importance of Gender-Neutral HPV Vaccination in Adults Up to Age 45 at International Papillomavirus Conference 2024 (Read Announcement) Cardiovascular Merck Announced Pivotal Phase 3 ZENITH Trial Evaluating WINREVAIR Met Primary Endpoint at Interim Analysis (Read Announcement) Merck Announced Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR Early and Move to Final Analysis (Read Announcement) Infectious Diseases Merck Announced Topline Results From Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults With Virologically Suppressed HIV-1 Infection (Read Announcement) Full-Year 2025 Financial Outlook The following table summarizes the company’s full-year financial outlook. Full Year 2025 Sales * $64.1 billion to $65.6 billion Non-GAAP Gross margin 2 Approximately 82.5% Non-GAAP Operating expenses 2** $25.4 billion to $26.4 billion Non-GAAP Other (income) expense, net 2 $300 million to $400 million expense Non-GAAP Effective tax rate 2 16.0% to 17.0% Non-GAAP EPS 2*** $8.88 to $9.03 Share count (assuming dilution) Approximately 2.53 billion *The company does not have any non-GAAP adjustments to sales. **Includes $300 million for an anticipated milestone payment to LaNova associated with the technology transfer for MK-2010 expected to be completed in 2025. Outlook does not assume any additional significant potential business development transactions. ***Includes expected one-time charge of approximately $0.09 per share related to the $300 million milestone payment to LaNova upon completion of the technology transfer for MK-2010. Merck has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the company’s future GAAP results. Merck anticipates full-year 2025 sales to be between $64.1 billion and $65.6 billion, including a negative impact of foreign exchange of approximately 2% at mid-January 2025 exchange rates. This sales range reflects a decision to temporarily pause shipments of GARDASIL/GARDASIL 9 into China beginning February 2025 through at least mid-year. Merck’s full-year non-GAAP effective income tax rate is expected to be between 16.0% and 17.0%. Merck expects full-year 2025 non-GAAP EPS to be between $8.88 and $9.03, including a negative impact of foreign exchange of approximately $0.35 per share. This range includes an expected one-time charge of $300 million, or approximately $0.09 per share, related to a milestone payment to LaNova, which will be recognized upon completion of the technology transfer for MK-2010. In 2024, non-GAAP EPS of $7.65 was negatively impacted by a net charge of $1.28 per share related to certain asset acquisitions, licensing agreements and collaborations. Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions. Earnings Conference Call Investors, journalists and the general public may access a live audio webcast of the earnings conference call on Tuesday, Feb. 4, at 9 a.m. ET via this weblink . A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com . All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Appendix Generic product names are provided below. Pharmaceutical BRIDION (sugammadex) CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) GARDASIL ( Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant ) GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) JANUMET (sitagliptin and metformin HCl) JANUVIA (sitagliptin) KEYTRUDA (pembrolizumab) LAGEVRIO (molnupiravir) Lenvima (lenvatinib) Lynparza (olaparib) M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live) PREVYMIS ( letermovir ) PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) Reblozyl (luspatercept) REMICADE (infliximab) ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent) SIMPONI (golimumab) VARIVAX (Varicella Virus Vaccine Live) VAXNEUVANCE ( Pneumococcal 15-valent Conjugate Vaccine ) WELIREG ( belzutifan ) WINREVAIR (sotatercept-csrk) Animal Health BRAVECTO (fluralaner) 1 Net income (loss) attributable to Merck & Co., Inc. 2 Merck is providing certain 2024 and 2023 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release. 3 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations and licensing arrangements. 4 Includes the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments, as well as a $260 million benefit and a $519 million benefit in the fourth quarter and full year of 2024, respectively, due to reductions in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years. The benefit recognized in the fourth quarter of 2024 relates to the 2020 federal tax return year and the benefit for the full year of 2024 relates to both the 2020 and 2019 federal tax return years. MERCK & CO., INC. CONSOLIDATED STATEMENT OF OPERATIONS - GAAP (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED) Table 1 GAAP % Change GAAP % Change 4Q24 4Q23 Full Year 2024 Full Year 2023 Sales $ 15,624 $ 14,630 7% $ 64,168 $ 60,115 7% Costs, Expenses and Other Cost of sales 3,828 3,911 -2% 15,193 16,126 -6% Selling, general and administrative 2,864 2,804 2% 10,816 10,504 3% Research and development 4,585 9,628 -52% 17,938 30,531 -41% Restructuring costs 51 255 -80% 309 599 -48% Other (income) expense, net 126 78 62% (24 ) 466 * Income (Loss) Before Taxes 4,170 (2,046 ) * 19,936 1,889 * Income Tax Provision (Benefit) 425 (821 ) 2,803 1,512 Net Income (Loss) 3,745 (1,225 ) * 17,133 377 * Less: Net Income Attributable to Noncontrolling Interests 2 1 16 12 Net Income (Loss) Attributable to Merck & Co., Inc. $ 3,743 $ (1,226 ) * $ 17,117 $ 365 * Earnings (Loss) per Common Share Assuming Dilution (1) $ 1.48 $ (0.48 ) * $ 6.74 $ 0.14 * Average Shares Outstanding Assuming Dilution (1) 2,537 2,533 2,541 2,547 Tax Rate 10.2 % 40.1 % 14.1 % 80.0 % * 100% or greater (1) Because the company recorded a net loss in the fourth quarter of 2023, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive. MERCK & CO., INC. FOURTH QUARTER AND FULL YEAR 2024 GAAP TO NON-GAAP RECONCILIATION (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED) Table 2a GAAP Acquisition and Divestiture Related Costs (1) Restructuring Costs (2) (Income) Loss from Investments in Equity Securities Certain Other Items Adjustment Subtotal Non-GAAP Fourth Quarter Cost of sales $ 3,828 701 121 822 $ 3,006 Selling, general and administrative 2,864 29 16 45 2,819 Research and development 4,585 12 (1) 11 4,574 Restructuring costs 51 51 51 – Other (income) expense, net 126 (31) 152 121 5 Income Before Taxes 4,170 (711) (187) (152) (1,050) 5,220 Income Tax Provision (Benefit) 425 (111) (3) (17) (3) (33) (3) (260) (4) (421) 846 Net Income 3,745 (600) (170) (119) 260 (629) 4,374 Net Income Attributable to Merck & Co., Inc. 3,743 (600) (170) (119) 260 (629) 4,372 Earnings per Common Share Assuming Dilution $ 1.48 (0.23) (0.07) (0.04) 0.10 (0.24) $ 1.72 Tax Rate 10.2% 16.2% Full Year Cost of sales $ 15,193 2,409 495 2,904 $ 12,289 Selling, general and administrative 10,816 117 83 200 10,616 Research and development 17,938 72 1 73 17,865 Restructuring costs 309 309 309 – Other (income) expense, net (24) (79) 45 (34) 10 Income Before Taxes 19,936 (2,519) (888) (45) (3,452) 23,388 Income Tax Provision (Benefit) 2,803 (461) (3) (135) (3) (10) (3) (519) (4) (1,125) 3,928 Net Income 17,133 (2,058) (753) (35) 519 (2,327) 19,460 Net Income Attributable to Merck & Co., Inc. 17,117 (2,058) (753) (35) 519 (2,327) 19,444 Earnings per Common Share Assuming Dilution $ 6.74 (0.81) (0.30) (0.01) 0.21 (0.91) $ 7.65 Tax Rate 14.1% 16.8% Only the line items that are affected by non-GAAP adjustments are shown. Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors’ understanding of the company’s results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. The non-GAAP information presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. (1) Amounts included in cost of sales primarily reflect expenses for the amortization of intangible assets. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. Amounts included in research and development expenses primarily reflect the amortization of intangible assets. Additionally, research and development expenses for the full year includes Animal Health intangible asset impairment charges. Amounts included in other (income) expense, net, primarily reflect royalty income and a decrease in the estimated fair value measurement of liabilities for contingent consideration related to the prior termination of the Sanofi-Pasteur MSD joint venture. (2) Amounts primarily include employee separation costs, accelerated depreciation and asset impairments associated with facilities to be closed or divested related to activities under the company's formal restructuring programs. (3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments. (4) Represents benefits recorded in the fourth quarter and full year due to reductions in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to federal income tax return years. The benefit recognized in the fourth quarter relates to the 2020 federal tax return year and the benefit recognized for the full year relates to both the 2020 and 2019 federal tax return years. MERCK & CO., INC. FRANCHISE / KEY PRODUCT SALES (AMOUNTS IN MILLIONS) (UNAUDITED) Table 3 2024 2023 4Q Full Year 1Q 2Q 3Q 4Q Full Year 1Q 2Q 3Q 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch % TOTAL SALES (1) $15,775 $16,112 $16,657 $15,624 $64,168 $14,487 $15,035 $15,962 $14,630 $60,115 7 9 7 10 PHARMACEUTICAL 14,006 14,408 14,943 14,042 57,400 12,721 13,457 14,263 13,141 53,583 7 8 7 10 Oncology Keytruda 6,947 7,270 7,429 7,836 29,482 5,795 6,271 6,338 6,608 25,011 19 21 18 22 Alliance Revenue – Lynparza (2) 292 317 337 365 1,311 275 310 299 315 1,199 16 18 9 11 Alliance Revenue – Lenvima (2) 255 249 251 255 1,010 232 242 260 226 960 13 14 5 6 Welireg 85 126 139 160 509 42 50 54 72 218 122 123 133 133 Alliance Revenue – Reblozyl (3) 71 90 100 110 371 43 47 52 70 212 58 58 75 75 Vaccines (4) Gardasil/Gardasil 9 2,249 2,478 2,306 1,550 8,583 1,972 2,458 2,585 1,871 8,886 -17 -18 -3 -2 ProQuad/M-M-R II/Varivax 570 617 703 594 2,485 528 582 713 545 2,368 9 9 5 5 Vaxneuvance 219 189 239 161 808 106 168 214 176 665 -9 -9 22 23 RotaTeq 216 163 193 139 711 297 131 156 185 769 -25 -25 -8 -7 Pneumovax 23 61 59 68 74 263 96 92 140 85 412 -12 -12 -36 -34 Hospital Acute Care Bridion 440 455 420 449 1,764 487 502 424 429 1,842 5 5 -4 -3 Prevymis 174 188 208 215 785 129 143 157 175 605 23 23 30 33 Dificid 73 92 96 79 340 65 76 74 87 302 -9 -9 13 13 Zerbaxa 56 62 64 70 252 50 54 53 61 218 14 16 16 18 Noxafil 56 45 41 36 177 60 55 51 46 213 -23 -17 -17 -8 Cardiovascular Winrevair 70 149 200 419 - - - - Alliance Revenue - Adempas/Verquvo (5) 98 106 102 109 415 99 68 92 108 367 1 1 13 13 Adempas (6) 70 72 72 73 287 59 65 65 66 255 11 9 12 14 Virology Lagevrio 350 110 383 121 964 392 203 640 193 1,428 -37 -37 -33 -28 Isentress/Isentress HD 111 89 102 92 394 123 136 119 105 483 -13 -7 -18 -14 Delstrigo 56 60 65 69 249 44 50 54 54 201 28 29 24 26 Pifeltro 42 39 42 40 163 34 38 37 33 142 20 20 15 15 Neuroscience Belsomra 46 53 78 45 222 56 63 58 54 231 -17 -17 -4 1 Immunology Simponi 184 172 189 543 180 180 179 171 710 N/M N/M -24 -23 Remicade 39 35 41 114 51 48 45 43 187 N/M N/M -39 -36 Diabetes (7) Januvia 419 405 278 232 1,334 551 511 581 547 2,189 -58 -56 -39 -36 Janumet 251 224 204 255 935 329 354 255 240 1,177 7 11 -21 -16 Other Pharmaceutical (8) 576 573 644 713 2,510 626 560 568 576 2,333 25 25 8 10 ANIMAL HEALTH 1,511 1,482 1,487 1,397 5,877 1,491 1,456 1,400 1,278 5,625 9 13 4 8 Livestock 850 837 886 889 3,462 849 807 874 808 3,337 10 14 4 9 Companion Animal 661 645 601 508 2,415 642 649 526 470 2,288 8 10 6 7 Other Revenues (9) 258 222 227 185 891 275 122 299 211 907 -13 3 -2 4 N/M - Not Meaningful Sum of quarterly amounts may not equal year-to-date amounts due to rounding. (1) Only select products are shown. (2) Alliance Revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs. (3) Alliance Revenue represents royalties. (4) Total Vaccines sales were $3,424 million, $3,656 million, $3,675 million and $2,693 million in the first, second, third and fourth quarter of 2024, respectively, and $3,133 million, $3,557 million, $4,002 million and $2,962 million in the first, second, third and fourth quarter of 2023, respectively. (5) Alliance Revenue represents Merck's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs. (6) Net product sales in Merck's marketing territories. (7) Total Diabetes sales were $745 million, $715 million, $592 million and $546 million in the first, second, third and fourth quarter of 2024, respectively, and $950 million, $951 million, $924 million and $876 million in the first, second, third and fourth quarter of 2023, respectively. (8) Includes Pharmaceutical products not individually shown above. (9) Other Revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Other Revenues related to the receipt of upfront and milestone payments for out-licensed products were $61 million, $15 million, $15 million and $15 million in the first, second, third and fourth quarter of 2024, respectively, and $51 million, $3 million and $65 million in the first, second and third quarter of 2023, respectively.