Merck & Co. (MRK) 10-K risk factor changes: FY2024 vs FY2023

The Company is subject to a number of risks that if realized could materially adversely affect its business, results of operations, cash [removed: flow,] [added: flows,] financial condition or prospects.

- The Company faces intense competition from both lower cost generic [added: and biosimilar] products and competitors’ products.

- Environmental, social and governance [removed: (ESG)] matters may impact the Company’s business and reputation.

- The Company is increasingly dependent on sophisticated software applications and computing [removed: infrastructure.][added: infrastructure, including the use of cloud-based applications and environments.]

The Company’s business, financial condition, results of operations, cash [removed: flow] [added: flows] or prospects could be materially adversely affected by any of these risks.

“Financial Statements and Supplementary Data,” Note [removed: 11.][added: 10.]

In the case of products that contribute significantly to the Company’s sales, the loss of market exclusivity can have a material adverse effect on the Company’s business, cash [removed: flow,] [added: flows,] results of operations, financial condition and prospects.

[removed: In 2023, the] [added: The] Company lost market exclusivity for *Bridion* in [removed: the EU] [added: Europe] and [added: Japan in 2023 and 2024, respectively, and] the Company has experienced a substantial decline in *Bridion* sales in those markets.

*Bridion* [removed: lost market exclusivity in Japan in January 2024 and] will lose market exclusivity in the U.S. in 2026 (subject to patent litigation discussed below) and the Company expects that sales [added: of *Bridion*] in [removed: those markets] [added: the U.S.] will decline substantially thereafter.

The Company’s ability to generate profits and operating cash [removed: flow] [added: flows] depends largely upon the continued profitability of the Company’s key products, such as *Keytruda*, *Gardasil/Gardasil* 9, Lynparza, *Bravecto*, and *Bridion*.

In [removed: 2023,] [added: 2024,] the Company’s oncology portfolio, led by *Keytruda*, [removed: and its vaccines portfolio, led by *Gardasil/Gardasil 9*,] represented substantially all of the Company’s revenue growth.

In particular, in the aggregate, in [removed: 2023,] [added: 2024,] sales of *Keytruda* [removed: and *Gardasil/Gardasil 9*] represented [removed: 56%] [added: 46%] of the Company’s total sales.

As a result of the Company’s dependence on key products, any event that adversely affects any of these products or the markets for any of these [removed: products] [added: products, such as the slowing demand for *Gardasil/Gardasil 9* in China which the Company has experienced,] could have a significant adverse impact on results of operations and financial condition.

[removed: These] [added: Other] events could include loss of patent protection, increased costs associated with manufacturing, generic or over-the-counter availability of the Company’s product or a competitive product, the discovery of previously unknown side effects, results of post-approval trials, increased competition from the introduction of new, more effective treatments and discontinuation or removal from the market of the product for any reason.

Failure to do so in the short term or long term would have a material adverse effect on the Company’s business, results of operations, cash [removed: flow,] [added: flows,] financial condition and prospects.

Failure to successfully develop and market new products in the short term or long term would have a material adverse effect on the Company’s business, results of operations, cash [removed: flow,] [added: flows,] financial condition and prospects.

“Competition and the Health Care Environment,” in 2023, HHS [removed: included] [added: selected] *Januvia* [removed: in] [added: for] the first year of the IRA’s price setting program, which [removed: absent further legislative or court intervention] will result in a government set price becoming effective on January 1, 2026.

Furthermore, the Company [removed: anticipates] [added: expects] that [added: in 2026] HHS will include *Keytruda* in a subsequent selection of products to undergo IRA price setting, with such price [removed: likely] to [removed: be] [added: become] effective [removed: in early 2028.][added: on January 1, 2028 and the Company expects that, as a result, U.S. sales of *Keytruda* will decline after that time.]

Consequently, in those markets, the Company is subject to government [added: decision making and budgetary actions with respect to its products.]

Uncertainty in global economic and geopolitical conditions may result in a slowdown to the global economy that could affect the Company’s business by reducing the prices that drug wholesalers and retailers, hospitals, government agencies and managed health care providers may be able or willing to pay for the Company’s products or by reducing the demand for the Company’s products, which could in turn negatively impact the Company’s sales and result in a material adverse effect on the Company’s business, cash [removed: flow,] [added: flows,] results of operations, financial condition and prospects.

In addition, the Company’s sales performance in [removed: 2023] [added: 2024] was negatively affected by other cost-reduction measures taken by governments and other third parties to lower health care [removed: costs.][added: costs, including in the U.S., the expansion of the Federal 340B Drug Discount Program.]

The Company anticipates all of these actions, and additional actions in the future, will [added: continue to] negatively affect sales and profits.

The Company faces intense competition from both lower cost generic [added: and biosimilar] products and competitors’ products.

In general, the Company faces increasing competition from lower-cost generic [added: and biosimilar] products.

Loss of patent protection for a product typically is followed promptly by generic [added: or biosimilar] substitutes, reducing the Company’s sales of that product.

Availability of generic substitutes for the Company’s drugs may adversely affect its results of operations and cash [removed: flow.][added: flows.]

Any such proposal that is enacted into law could worsen this substantial negative effect on the Company’s sales, business, cash [removed: flow,] [added: flows,] results of operations, financial condition and prospects.

As a result, if the Company fails to maintain its competitive position, this could have a material adverse effect on its business, cash [removed: flow,] [added: flows,] results of operations, financial condition and prospects.

Events like these, such as the ongoing war between Russia and Ukraine, and [removed: rising] [added: the] conflict in the Middle East, [added: and/or policy changes with respect to international trade protection measures,] could result in material adverse effects on macroeconomic conditions, currency exchange rates and financial markets, and may adversely affect the Company’s business, results of [removed: operations] [added: operations, cash flows] and financial condition.

The Company believes that climate change has the potential to negatively affect its [removed: business and] [added: business,] results of operations, cash [removed: flow] [added: flows] and prospects.

New legal [removed: or] [added: and] regulatory requirements [removed: may be] [added: are being] enacted to prevent, mitigate, or adapt to the implications of a changing climate and its effects on the environment.

These regulations, which may differ across jurisdictions, could result in the Company being subject to new or expanded carbon pricing or taxes, increased compliance costs, restrictions on [removed: greenhouse gas] [added: GHG] emissions, investment in new technologies, increased [removed: greenhouse gas] [added: GHG] emission disclosure (including costs resulting from mandatory or voluntary reporting, diligence or disclosure) and transparency, recurring investments in data gathering and reporting systems, upgrades of facilities to meet new building codes, and the redesign of utility systems, which could increase the Company’s operating costs, including the cost of electricity and energy used by the Company.

Environmental, social and governance [removed: (ESG)] matters may impact the Company’s business and reputation.

Governmental authorities, non-governmental organizations, customers, investors, external stakeholders and employees are [removed: increasingly] sensitive to [removed: ESG] [added: environmental, social and governance] concerns, such as [removed: diversity and inclusion,] [added: human capital,] climate change, water use, recyclability or recoverability of packaging, and plastic waste.

[removed: This] [added: The] focus on [removed: ESG] [added: these] concerns may lead to new requirements that could result in increased costs associated with developing, manufacturing and distributing the Company’s products, and related reporting obligations.

The Company’s ability to compete could also be affected by changing customer preferences and requirements, such as growing demand for validated net zero [removed: greenhouse gas] [added: GHG] emission targets and more environmentally friendly products, packaging or supplier practices, or by failure to meet such customer expectations or demand.

[removed: While the Company strives to improve its ESG performance and has set certain ESG goals and initiatives, the] [added: The] Company risks negative shareholder reaction, including from proxy advisory services, as well as damage to its brand and reputation and inability to attract and retain employee talent, if the Company fails to [removed: meet its goals and initiatives or otherwise does not] act responsibly, or if the Company is perceived to not be acting responsibly, in key [removed: ESG] areas, including equitable access to medicines and vaccines, product quality and safety, [removed: diversity and inclusion,] environmental stewardship, reduction of [removed: greenhouse gas] [added: GHG] emissions, support for local communities, corporate governance and transparency, and addressing human capital factors in the Company’s operations.

Responding to these [removed: ESG] considerations [added: as well as any applicable regulatory requirements] and implementation of the Company’s [removed: ESG] goals and initiatives involves risks and uncertainties, requires investments, and depends in part on third-party performance or data that is outside of the Company’s control.

In addition, some [added: governmental authorities, non-governmental organizations, and] stakeholders may disagree with the Company’s [removed: ESG] goals and initiatives.

If the Company does not meet the evolving and varied [removed: ESG] [added: regulatory requirements and] expectations of its investors, customers and other stakeholders, the Company could experience [removed: reduced demand for its products, loss of customers, and other] negative impacts [removed: on] [added: to] the Company’s business and results of operations.

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In 2024, the Company experienced lower sales of *Gardasil/Gardasil 9* in China and expects that sales of *Gardasil/Gardasil 9* in China will decline significantly in 2025.

- The Company is increasing its use of artificial intelligence (AI) systems to automate processes, analyze data, and support decision-making which poses inherent risks.

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In addition, the Company expects U.S. sales of *Keytruda* to decline beginning in January 2028 upon implementation of government pricing under the IRA, and to further decline upon loss of market exclusivity following expiration of the U.S. compound patent in December 2028.

The Company expects to lose market exclusivity in Europe for *Keytruda* in 2031 following compound patent expiration.

There may, however, be attempts by one or more companies to challenge the patent or launch a biosimilar product despite the patent in some European jurisdictions following the expiration of data exclusivity in Europe in July 2026.

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Government price setting may also impact pricing in the private market, negatively affecting the Company’s performance.

In January 2025, HHS announced that *Janumet* and *Janumet XR* have been selected for government price setting, which will become effective on January 1, 2027.

The Company is also facing pricing pressure from purchasers of certain vaccines in highly competitive categories.

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The U.S. government has announced plans to significantly increase tariffs on foreign imports into the U.S., particularly from Canada and Mexico and has already increased tariffs on imports from China.

It is too early for the

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Company to assess if, or to what extent, such policies will be implemented or continue to be implemented, and the extent of any measures that have been or will be taken by any impacted countries.

In addition, the Company is subject to expanding mandatory and voluntary reporting, diligence and disclosure requirements, including the EU’s Corporate

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For example, the Company is currently experiencing manufacturing delays related to *Varivax* and *ProQuad* which will result in supply constraints in 2025.

The Company’s business in China has grown in the past few years, and the importance of China to the Company’s overall pharmaceutical and vaccines business has increased accordingly.

In 2024, the Company experienced lower sales of Gardasil/Gardasil 9 in China and expects that sales of Gardasil/Gardasil 9 in China will decline significantly in 2025.

The Company’s business in China has grown in the past few years, and the importance of China to the Company’s overall pharmaceutical and vaccines business has increased accordingly.

Beginning in mid-2024, the Company observed a significant decline in shipments from its distributor and commercialization partner in China, Chongqing Zhifei Biological Products Co., Ltd. (Zhifei), to disease and control prevention institutions and correspondingly into the points of vaccination, resulting in above normal inventory levels at Zhifei.

Accordingly, the Company shipped less than its contracted doses to Zhifei in the latter part of 2024.

Lower demand in China persisted and, at the end of 2024, overall channel inventory levels in China remained elevated at above normal levels.

Therefore, the Company made a decision to temporarily pause shipments to China beginning in February 2025 through at least the middle of the year and as a result, combined sales of G*ardasil/Gardasil 9* will decline significantly in 2025 compared with 2024.

Furthermore, the government's anti-corruption campaign, particularly the increased number of inspections and audits, could substantially increase the administrative burden on health care institutions and health care professionals throughout the whole industry in China and potentially have a negative impact on the Company's sales.

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Furthermore, government price setting may also impact pricing in the private market, negatively affecting the Company’s performance.

“Competition and the Health Care Environment,” in 2023, HHS selected *Januvia* for the first year of the IRA’s price setting program, which will result in a government set price becoming effective on January 1, 2026.

On January 17, 2025, HHS announced that *Janumet* and *Janumet XR* have been selected for government price setting, which will become effective on January 1, 2027.

Furthermore, the Company expects that in 2026 HHS will include *Keytruda* in a subsequent selection of products to undergo IRA price setting, with such price to become effective on January 1, 2028 and the Company expects that, as a result, U.S. sales of *Keytruda* will decline after that time.

Additionally, increased utilization of the 340B Federal Drug Discount Program and restrictions on the Company’s ability to identify inappropriate discounts are having a negative impact on the Company’s performance.

Also, the Company expects that states will continue their focus on pharmaceutical pricing and will increasingly shift to more aggressive price control tools such as Prescription Drug Affordability Boards that have the authority to conduct affordability reviews and establish upper payment limits and that Company products may be selected for such reviews.

In the U.S., members of the government have made public statements in favor of, and may take steps to implement, various regulatory changes that could negatively impact the pharmaceutical industry, including the Company.

Those potential changes include some related to vaccines and vaccine development, as well as personnel and policy changes at the FDA and other government agencies and programs.

For example, HHS could undergo changes that could make it more difficult for the FDA to grant regulatory approvals for drugs and vaccines and the U.S. Centers for Disease Control and Prevention (CDC) to issue or maintain recommendations for vaccines.

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In addition, the Company expects to lose market exclusivity in the U.S. for *Keytruda* in 2028 and the Company anticipates that sales of *Keytruda* in the U.S. will decline substantially thereafter.

In order to provide information about the Company’s pricing practices, the Company annually posts on its website its Pricing Transparency Report for the U.S. The report provides the Company’s average annual list price and net price increases across the Company’s U.S. portfolio dating back to 2010.

In 2023, the Company’s gross U.S. sales were reduced by 37% as a result of rebates, discounts and returns.

decision making and budgetary actions with respect to its products.

In addition, the Company is subject to expanding ESG mandatory and voluntary reporting, diligence and disclosure requirements, including the EU’s Corporate Sustainability Reporting Directive (CSRD) and potentially the SEC’s proposed climate-related reporting requirements, the recently enacted legislation in California requiring reporting of greenhouse gas emissions and climate risk, and similar regulatory requirements in other jurisdictions.

For example, in 2020 the Company issued a product recall for *Zerbaxa* following the identification of product sterility issues and in 2023 the Company voluntarily recalled certain batches of *Vaxneuvance* in the U.S. due to instances of syringe breakage.

As previously disclosed, the Company is working to reduce the level of nitrosamines in its sitagliptin-containing medicines such as *Januvia*.

The Company has made significant progress in reducing the level of nitrosamines and is now consistently releasing product in major markets that is expected to comply with the health authorities’ long-term limit.

However, difficulties in reducing those levels, or achieving timely regulatory approvals for required changes, could result in product shortages.

In the U.S., the Biden Administration and Congress continue to discuss legislation designed to control health care costs, including the cost of drugs.

countries.

acquisition; the use of which can create new risks.

A drug candidate can fail at any stage of

The following section of this Form 10-K generally discusses [removed: 2023] [added: 2024] and [removed: 2022] [added: 2023] results and year-to-year comparisons between [removed: 2023] [added: 2024] and [removed: 2022.][added: 2023.]

Discussion of [removed: 2021] [added: 2022] results and year-to-year comparisons between [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] that are not included in this Form 10-K can be found in Part II, Item 7.

“Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2022] [added: 2023] filed on February [removed: 24, 2023.][added: 26, 2024.]

| *($ in millions except per share amounts)* | | | [removed: 2023] [added: 2024] | | | | | | % Change | | | | | | % Change Excluding Foreign Exchange | | | | | | [removed: 2022] [added: 2023] | | | | | | % Change | | | | | | % Change Excluding Foreign Exchange | | | | | | [removed: 2021] [added: 2022] | | |

| Sales | | | $ | [removed: 60,115] [added: 64,168] | | | | | [removed: 1] [added: 7] | | % | | | | [removed: 4] [added: 10] | | % | | | | $ | [removed: 59,283] [added: 60,115] | | | | | [removed: 22] [added: 1] | | % | | | | [removed: 26] [added: 4] | | % | | | | $ | [removed: 48,704] [added: 59,283] | |

| Net Income [removed: from Continuing Operations] Attributable to Merck & Co., Inc.: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| GAAP | | | $ | [removed: 365] [added: 17,117] | | | | | [removed: (97)] [added: *] | | [removed: %] | | | | [removed: (95)] [added: *] | | [removed: %] | | | | $ | [removed: 14,519] [added: 365] | | | | | [removed: 18] [added: (97)] | | % | | | | [removed: 21] [added: (95)] | | % | | | | $ | [removed: 12,345] [added: 14,519] | |

| Non-GAAP *(1)* | | | $ | [removed: 3,837] [added: 19,444] | | | | | [removed: (80)] [added: *] | | [removed: %] | | | | [removed: (75)] [added: *] | | [removed: %] | | | | $ | [removed: 19,005] [added: 3,837] | | | | | [removed: 40] [added: (80)] | | % | | | | [removed: 43] [added: (75)] | | % | | | | $ | [removed: 13,623] [added: 19,005] | |

| Earnings per Common Share Assuming Dilution [removed: from Continuing Operations] Attributable to Merck & Co., Inc. Common Shareholders: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| GAAP | | | $ | [removed: 0.14] [added: 6.74] | | | | | [removed: (98)] [added: *] | | [removed: %] | | | | [removed: (95)] [added: *] | | [removed: %] | | | | $ | [removed: 5.71] [added: 0.14] | | | | | [removed: 17] [added: (98)] | | % | | | | [removed: 21] [added: (95)] | | % | | | | $ | [removed: 4.86] [added: 5.71] | |

| Non-GAAP *(1)* | | | $ | [removed: 1.51] [added: 7.65] | | | | | [removed: (80)] [added: *] | | [removed: %] | | | | [removed: (75)] [added: *] | | [removed: %] | | | | $ | [removed: 7.48] [added: 1.51] | | | | | [removed: 39] [added: (80)] | | % | | | | [removed: 43] [added: (75)] | | % | | | | $ | [removed: 5.37] [added: 7.48] | |

For further discussion and a reconciliation of GAAP to non-GAAP net income and EPS, see “Non-GAAP Income and Non-GAAP [removed: EPS from Continuing Operations”] [added: EPS”] below*.

[removed: leading edge science, and] [added: Merck] advanced its [removed: broad] [added: robust early- and late-phase] pipeline which includes growing diversity across new therapeutic areas and [removed: modalities.][added: modalities and completed several promising business development transactions.]

[removed: ][added: ]

Worldwide sales were [removed: $60.1] [added: $64.2] billion in [removed: 2023,] [added: 2024,] an increase of [removed: 1%] [added: 7%] compared with [removed: 2022,] [added: 2023,] or [removed: 4%] [added: 10%] excluding the unfavorable effect of foreign exchange.

The sales increase was primarily due to growth in oncology, [removed: vaccines, hospital acute care] [added: cardiovascular] and animal health, partially offset by declines in [added: diabetes,] virology (driven [added: largely] by lower sales of COVID-19 medication [removed: *Lagevrio*)] [added: *Lagevrio*), immunology (as Merck’s marketing rights to these products ended in 2024)] and [removed: diabetes.][added: vaccines.]

Merck continues to execute [removed: strategic] [added: value creating] business development opportunities [added: focused on innovation] to augment its robust internal pipeline with compelling external science.

Highlights of [removed: 2023] [added: 2024] activity include the following:

[removed: During 2023, the] [added: The] Company received more than 25 regulatory approvals in major [removed: markets,] [added: markets in 2024,] including [added: the *Winrevair* and *Capvaxive* approvals noted above, along with] numerous [removed: regulatory] approvals [removed: within] [added: in] oncology.

*Keytruda* received approval for additional indications in the U.S. and/or internationally as monotherapy in the therapeutic areas of [removed: non-small-cell lung cancer (NSCLC)] [added: hepatocellular carcinoma (HCC), melanoma] and [removed: primary mediastinal large B-cell lymphoma (PMBCL),] [added: urothelial carcinoma,] in combination with chemotherapy in the therapeutic areas of biliary tract cancer, [added: cervical cancer, endometrial carcinoma,] gastric or gastroesophageal junction (GEJ) [removed: adenocarcinoma] [added: adenocarcinoma, malignant pleural mesothelioma] and [removed: NSCLC,] [added: non-small-cell lung cancer (NSCLC),] as well as in combination with Padcev (enfortunab vedotin-ejfv) for advanced urothelial [removed: cancer.][added: carcinoma.]

In addition to the [removed: recent] regulatory approvals discussed above, the Company advanced its late-stage pipeline with several regulatory submissions.

- V116, [removed: an investigational] [added: *Capvaxive*, a] 21-valent pneumococcal conjugate vaccine [removed: for the prevention of] [added: designed to help prevent] invasive pneumococcal disease and pneumococcal pneumonia [added: caused by certain serotypes] in adults, is [removed: also] under [removed: priority] review [removed: by] [added: in] the [removed: FDA.][added: EU and Japan.]

[removed: -] *Welireg* is [added: also] under [added: priority] review in the [removed: EU] [added: U.S.] for the treatment of certain patients with [removed: advanced RCC] [added: advanced, unresectable or metastatic pheochromocytoma] and [removed: for the treatment of von Hippel-Lindau disease.][added: paraganglioma.]

- [removed: *Keytruda*] [added: MK-3475, *Keytruda*,] in the therapeutic areas of [removed: cutaneous squamous cell,] hepatocellular, [removed: mesothelioma,] ovarian and small-cell lung cancers;

- MK-1308A, the coformulation of quavonlimab, Merck’s novel investigational anti-CTLA-4 antibody, [removed: and] [added: in combination with] pembrolizumab for RCC;

- MK-3475A, the subcutaneous coformulation of pembrolizumab [added: in combination] with [removed: hyaluronidase] [added: hyaluronidase, being evaluated] for [removed: certain types of] [added: comparability with intravenous pembrolizumab in metastatic] NSCLC; [added: and]

- [removed: V940,] [added: V940 (mRNA-4157),] an investigational individualized neoantigen therapy, in combination with *Keytruda*, [removed: for] [added: as an adjuvant treatment in patients with] certain types of melanoma and NSCLC, being developed [removed: in] [added: as part of a] collaboration with [removed: Moderna.][added: Moderna, Inc.]

- [removed: Lynparza] [added: MK-7339, Lynparza,] in combination with [removed: *Keytruda*] [added: *Keytruda*,] for non-small-cell lung and small-cell lung cancers; [added: and]

- [added: MK-7902,] Lenvima, being developed [removed: in] [added: as part of a] collaboration with Eisai Co., Ltd. (Eisai), in combination with [removed: *Keytruda*] [added: *Keytruda*,] for [removed: certain types of] esophageal [removed: and gastric cancers;][added: cancer.]

- MK-1026, nemtabrutinib, an oral, reversible, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, for hematological [removed: malignancies;][added: malignancies, including chronic lymphocytic leukemia and small lymphocytic lymphoma;]

- MK-3543, bomedemstat, an investigational orally available lysine-specific demethylase 1 inhibitor for myeloproliferative disorders; [removed: and]

[removed: *•*MK-2870,] [added: - MK-2870, sacituzumab tirumotecan,] an investigational trophoblast cell-surface antigen 2 (TROP2)-directed [removed: ADC] [added: ADC,] being developed [removed: in] [added: as part of a] collaboration with Kelun-Biotech for [removed: endometrial carcinoma] [added: breast, cervical, endometrial, gastric] and [removed: certain types of NSCLC.][added: non-small-cell lung cancers.]

Additionally, the Company currently has candidates in Phase 3 clinical development in several other therapeutic [removed: areas including:][added: areas:]

- MK-0616, [added: enlicitide decanoate,] an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for [removed: hypercholesterolemia;][added: hypercholesterolemia, including in studies evaluating low-density lipoprotein cholesterol reduction and a cardiovascular outcomes study;]

- MK-7240, tulisokibart, a humanized monoclonal antibody directed to tumor necrosis factor-like ligand 1A, a target associated with both intestinal inflammation and fibrosis, for [added: Crohn’s disease and] ulcerative colitis; [added: and]

- MK-8591A, [added: a once-daily oral combination of doravirine and] islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, [removed: in combination with doravirine] for the treatment of HIV-1 infection (which is on partial clinical hold for higher doses [added: of islatravir] than those used in current clinical trials); [removed: and]

Merck’s capital allocation strategy continues to prioritize investments in its business to drive near- and long-term growth, including investing in [removed: opportunities] [added: the Company’s key growth drivers and expansive pipeline of novel candidates, each of which has potential] to address important unmet medical [removed: needs and supporting the Company’s commercial opportunities.][added: needs.]

Research and development expenses in [removed: 2023] [added: 2024] reflect [removed: higher charges for business development transactions and] increased development spending particularly in the therapeutic areas of oncology, [removed: cardiovascular, infectious diseases] [added: immunology] and [removed: vaccines.][added: cardiometabolic.]

[removed: ][added: ]

In November [removed: 2023,] [added: 2024,] Merck’s Board of Directors approved an increase to the Company’s quarterly dividend, raising it to [removed: $0.77] [added: $0.81] per share from [removed: $0.73] [added: $0.77] per share on the Company’s outstanding common stock.

Merck’s performance during 2024 was driven by continued demand across its innovative portfolio, including for recently launched products, enabled by the operational and commercial execution of its science-led strategy.

The Company maintained its focus on the pursuit of breakthrough science and innovation, making disciplined investments in compelling science to drive long-term value for patients, customers, and shareholders.

The Company continued to return capital to shareholders, primarily through dividends.

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

- Closed an exclusive global license to develop, manufacture and commercialize MK-2010 (LM-299), a novel investigational programmed death receptor-1 (PD-1)/vascular endothelial growth factor (VEGF) bispecific antibody from LaNova Medicines Ltd (LaNova).

- Closed an exclusive global license to develop, manufacture and commercialize MK-4082 (HS-10535), an investigational preclinical oral small molecule GLP-1 receptor agonist from Hansoh Pharma (Hansoh).

- Acquired global rights to MK-1045 (formerly CN201), a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases from Curon Pharmaceutical (Curon).

- Acquired Eyebiotech Limited (EyeBio), a privately held ophthalmology-focused biotechnology company developing candidates for the prevention and treatment of vision loss.

During 2024, Merck continued its efforts to address unmet medical needs by launching new products with significant patient benefit, including the U.S. launches of *Winrevair*, for the treatment of certain adults with pulmonary arterial hypertension (PAH), and *Capvaxive,* for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.

*Winrevair* was also approved in the EU.

Also in 2024, *Welireg* was approved in China for the treatment of adult patients with certain von Hippel-Lindau (VHL) disease-associated tumors not requiring immediate surgery.

Lynparza, which is being developed in collaboration with AstraZeneca PLC (AstraZeneca), received approval in China for the treatment of certain adult patients with germline *BRCA*\-mutated, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer.

- MK-1022, patritumab deruxtecan, is a potential first-in-class HER3 directed DXd antibody drug conjugate (ADC), under review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC previously treated with two or more systemic therapies.

In June 2024, the FDA issued a complete response letter (CRL) for the Biologics License Application (BLA) due to findings pertaining to an inspection of a third-party manufacturing facility.

The CRL did not identify any issues with the efficacy or safety data submitted.

Patritumab deruxtecan (HER3-DXd) was discovered by Daiichi Sankyo and is

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

being jointly developed by Daiichi Sankyo and Merck.

Merck is working with Daiichi Sankyo to address FDA feedback.

- MK-6482*, Welireg,* is under review in Japan both for the treatment of adults with VHL disease and for the treatment of certain adults with previously treated advanced renal cell carcinoma (RCC).

- MK-7962, *Winrevair*, Merck’s novel activin signaling inhibitor, is under review in Japan for the treatment of adult patients with PAH.

- MK-1654, clesrovimab, is an investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season under review by the FDA.

- Additionally, *Keytruda* is under review in the EU and Japan for a supplemental indication for the treatment of certain patients with malignant pleural mesothelioma.

During 2024, the Company initiated more than 20 Phase 3 studies spanning cardiometabolic, immunology, infectious diseases, oncology, ophthalmology and vaccines.

- MK-1084, an investigational oral selective *KRAS* G12C inhibitor, in combination with *Keytruda*, for metastatic NSCLC;

- MK-5684, opevesostat, an investigational cytochrome P450 11A1 (CYP11A1) inhibitor for metastatic castration-resistant prostate cancer;

*•*MK-1022, patritumab deruxtecan, being developed in collaboration wtih Daiichi Sankyo, for NSCLC as noted above;

- MK-2140, zilovertamab vedotin, an ADC targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1) for hematological malignancies, including diffuse large B cell lymphoma;

- MK-2400, ifinatamab deruxtecan, an ADC being evaluated in patients with relapsed SCLC versus chemotherapy, being developed as part of a collaboration with Daiichi Sankyo; and

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

- MK-3000, an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site signaling pathway, for the treatment of diabetic macular edema and neovascular age-related macular degeneration;

- MK-8591D, islatravir in combination with lenacapavir for the treatment of HIV-1 infection (which is on partial clinical hold for higher doses of islatravir than those used in current clinical trials), being developed in collaboration with Gilead Sciences Inc.;

In January 2025, Merck’s Board of Directors authorized a new share repurchase program of up to an additional $10 billion of Merck’s common stock for its treasury.

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

In 2021, the U.S. Congress passed the American Rescue Plan Act, which included a provision that eliminated the statutory cap on rebates drug manufacturers pay to Medicaid beginning in January 2024.

As a result of this provision, the Company paid state Medicaid programs more in rebates than it received on Medicaid sales of *Januvia*, *Janumet* and *Janumet* XR in 2024.

Government price setting may also impact pricing in the private market negatively affecting the Company’s performance.

In January 2025, the U.S. Department of HHS, through the CMS, announced that *Janumet* and *Janumet* XR would be in included in the second year of the IRA’s Program, with government price setting to become effective on January 1, 2027.

Additionally, increased utilization of the 340B Federal Drug Discount Program and restrictions on the Company’s ability to identify inappropriate discounts are having a negative impact on Company performance.

Worldwide sales were $64.2 billion in 2024, representing growth of 7% compared with 2023, or 10% excluding the unfavorable effect of foreign exchange.

On June 2, 2021, Merck completed the spin-off of products from its women’s health, biosimilars and established brands businesses into a new, independent, publicly traded company named Organon & Co. (Organon) through a distribution of Organon’s publicly traded stock to Company shareholders.

The established brands included in the transaction consisted of dermatology, non-opioid pain management, respiratory, select cardiovascular products, as well as the rest of Merck’s diversified brands franchise.

The historical results of the businesses that were contributed to Organon in the spin-off have been reflected as discontinued operations in the Company’s consolidated financial statements through the date of the spin-off (see Note 5 to the consolidated financial statements).

Merck’s performance during 2023 reflects strong execution of its science-led strategy.

The Company benefited from strong underlying demand across its innovative portfolio, made disciplined investments to leverage

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Additionally, Merck completed several strategic business development transactions and returned capital to shareholders, primarily through dividends.

- Entered into a global development and commercialization agreement for three of Daiichi Sankyo’s deruxtecan (DXd) antibody drug conjugate (ADC) candidates, which are in various stages of clinical development for the treatment of multiple solid tumors both as monotherapy and/or in combination with other treatments.

- Acquired Prometheus Biosciences, Inc. (Prometheus), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases including ulcerative colitis, Crohn’s disease, and other autoimmune conditions.

- Closed a license and collaboration agreement expanding the Company’s relationship with Kelun-Biotech pursuant to which Merck gained exclusive rights for the research, development, manufacture and commercialization of up to now five investigational preclinical ADCs for the treatment of cancer (Kelun-Biotech retained rights for certain licensed and option ADCs for Chinese mainland, Hong Kong and Macau).

- Acquired Imago BioSciences, Inc. (Imago), a clinical-stage biopharmaceutical company developing new medicines for the treatment of myeloproliferative neoplasms and other bone marrow diseases.

Lynparza, which is being developed in collaboration with AstraZeneca PLC (AstraZeneca), received approvals in the U.S. in combination with abiraterone and prednisone or prednisolone and in Japan in combination with abiraterone and prednisolone - both for the treatment of certain adult patients with *BRCA*\-mutated (*BRCA*m) metastatic castration-resistant prostate cancer (mCRPC).

*Welireg* was approved for a supplemental indication in the U.S. for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Additionally, in 2023, *Prevymis* was approved for a supplemental indication in both the U.S. and the EU for prophylaxis (prevention) of cytomegalovirus (CMV) disease in certain adult kidney transplant recipients at high risk.

- MK-7962, sotatercept, a novel investigational activin signaling inhibitor is under priority review by the U.S. Food and Drug Administration (FDA) and under review by the European Medicines Agency for the treatment of adult patients with pulmonary arterial hypertension (PAH).

- MK-1022, patritumab deruxtecan, is an ADC being evaluated for the treatment of certain types of NSCLC under priority review by the FDA.

Patritumab deruxtecan is part of a collaboration with Daiichi Sankyo.

- Additionally, *Keytruda* is under review in the U.S. and/or in international markets for supplemental indications for the treatment of certain patients with biliary tract, cervical, endometrial, gastric, non-small-cell lung and urothelial cancers.

During 2023, the Company initiated more than 20 Phase 3 studies across multiple asset classes, including the progression of eight novel candidates.

- MK-4280A, the coformulation of favezelimab, Merck’s novel investigational anti-LAG3 therapy, and pembrolizumab for colorectal cancer and hematological malignancies;

- MK-7684A, the coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab for certain types of melanoma, non-small-cell and small-cell lung cancers; and

- MK-5684, an investigational cytochrome P450 11A1 (CYP11A1) inhibitor being developed in collaboration with Orion Corporation (Orion) for mCRPC.

- MK-1654, clesrovimab, a human monoclonal antibody for the prevention of respiratory syncytial virus (RSV);

Furthermore, the Biden

Also contributing to revenue growth were higher sales in the vaccines franchise, primarily attributable to growth of combined sales of *Gardasil/Gardasil* 9 and the ongoing launch of *Vaxneuvance* for pediatric use.

Higher sales of hospital acute care products, including *Prevymis* and *Bridion*, as well as higher sales of animal health products also drove revenue growth in 2023.

Lower sales in the diabetes franchise, due to *Januvia* and *Janumet*, lower sales of the *Pneumovax* 23 vaccine, and lower revenue from third-party manufacturing arrangements also offset sales growth in 2023.

Revenue growth in the U.S. in 2023 was partially offset by lower sales of *Lagevrio*, *Pneumovax* 23, *Janumet*, *Januvia*, and lower revenue from third-party manufacturing arrangements.

International sales declined 1% in 2023 primarily due to lower sales of *Lagevrio*, *Januvia, Janumet*, and *Isentress/Isentress HD*.

The international sales decline in 2023 was largely offset by higher combined sales of *Gardasil/Gardasil* 9, as well as higher sales of *Keytruda*, *Prevymis* and *Vaxneuvance.* International sales represented 53% and 54% of total sales in 2023 and 2022, respectively.

Global sales of *Keytruda* grew 19% in 2023 primarily driven by higher demand reflecting the launch of multiple new indications globally coupled with continued uptake in existing indications.

metastatic indications, in particular for the treatment of certain types of RCC, NSCLC, TNBC, head and neck squamous cell carcinoma (HNSCC), endometrial and bladder cancers, as well as higher pricing.

| Date | | | Approval | | |

| January 2023 | | | FDA approval as a single agent for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC, based on the KEYNOTE-091 trial. | | |

| March 2023 | | | FDA full approval for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. The conversion from an accelerated to a full (regular) approval is based on the KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 trials. | | |

| June 2023 | | | Japan’s Ministry of Health, Labor and Welfare (MHLW) approval for the treatment of patients with relapsed or refractory PMBCL, based on the KEYNOTE-170 and the KEYNOTE-A33 studies. | | |

| September 2023 | | | China’s National Medical Products Administration (NMPA) approval as monotherapy for the treatment of adult patients with advanced unresectable or metastatic MSI-H or dMMR solid tumors, including patients with colorectal cancer that have progressed following treatment with fluoropyrimidine, oxaliplatin, or irinotecan, or those with other solid tumors that have progressed following prior therapy and who have no satisfactory alternative treatment options, based on the KEYNOTE 158 and KEYNOTE-164 trials. | | |

| October 2023 | | | FDA full approval for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The conversion from an accelerated to a full (regular) approval is based on the KEYNOTE-913 and KEYNOTE-017 trials. | | |

| December 2023 | | | FDA full approval in combination with Padcev (enfortumab vedotin-ejfv), an ADC, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. The conversion from an accelerated to a full (regular) approval is based on the KEYNOTE-A39 trial that was conducted in collaboration with Seagen (now Pfizer) and Astellas. | | |

| December 2023 | | | EC approval in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma in adults whose tumors express PD-L1, based on the KEYNOTE-859 trial. | | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

All other trademarks or [removed: services] [added: service] marks are those of their respective owners.

| *($ in millions)* | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |

| Total Sales | | | $ | [removed: 60,115] [added: 64,168] | | | | | $ | [removed: 59,283] [added: 60,115] | | | | | $ | [removed: 48,704] [added: 59,283] | |

| Pharmaceutical | | | [removed: 53,583] [added: 57,400] | | | | | | [removed: 52,005] [added: 53,583] | | | | | | [removed: 42,754] [added: 52,005] | | |

| *Keytruda* | | | [removed: 25,011] [added: 29,482] | | | | | | [removed: 20,937] [added: 25,011] | | | | | | [removed: 17,186] [added: 20,937] | | |

| *Gardasil/Gardasil* 9 | | | [removed: 8,886] [added: 8,583] | | | | | | [removed: 6,897] [added: 8,886] | | | | | | [removed: 5,673] [added: 6,897] | | |

| *Januvia/Janumet* | | | [removed: 3,366] [added: 2,268] | | | | | | [removed: 4,513] [added: 3,366] | | | | | | [removed: 5,288] [added: 4,513] | | |

| *ProQuad/M-M-R* II*/Varivax* | | | [removed: 2,368] [added: 2,485] | | | | | | [removed: 2,241] [added: 2,368] | | | | | | [removed: 2,135] [added: 2,241] | | |

| *Bridion* | | | [removed: 1,842] [added: 1,764] | | | | | | [removed: 1,685] [added: 1,842] | | | | | | [removed: 1,532] [added: 1,685] | | |

| *Lagevrio* | | | [removed: 1,428] [added: 964] | | | | | | [removed: 5,684] [added: 1,428] | | | | | | [removed: 952] [added: 5,684] | | |

| Alliance revenue - Lynparza*(1)* | | | [removed: 1,199] [added: 1,311] | | | | | | [removed: 1,116] [added: 1,199] | | | | | | [removed: 989] [added: 1,116] | | |

| Alliance revenue - Lenvima*(1)* | | | [removed: 960] [added: 1,010] | | | | | | [removed: 876] [added: 960] | | | | | | [removed: 704] [added: 876] | | |

| *RotaTeq* | | | [removed: 769] [added: 711] | | | | | | [removed: 783] [added: 769] | | | | | | [removed: 807] [added: 783] | | |

| *Vaxneuvance* | | | [removed: 665] [added: 808] | | | | | | [removed: 170] [added: 665] | | | | | | [removed: 3] [added: 170] | | |

| Animal Health | | | [removed: 5,625] [added: 5,877] | | | | | | [removed: 5,550] [added: 5,625] | | | | | | [removed: 5,568] [added: 5,550] | | |

| Livestock | | | [removed: 3,337] [added: 3,462] | | | | | | [removed: 3,300] [added: 3,337] | | | | | | [removed: 3,295] [added: 3,300] | | |

| Companion Animal | | | [removed: 2,288] [added: 2,415] | | | | | | [removed: 2,250] [added: 2,288] | | | | | | [removed: 2,273] [added: 2,250] | | |

| Other Revenues*(2)* | | | [removed: 907] [added: 891] | | | | | | [removed: 1,728] [added: 907] | | | | | | [removed: 382] [added: 1,728] | | |

*Keytruda* is an anti-PD-1 (programmed death receptor-1) therapy that has been approved as monotherapy for the treatment of certain patients with cervical cancer, classical Hodgkin [removed: lymphoma,] [added: lymphoma (cHL),] cutaneous squamous cell carcinoma, esophageal or gastroesophageal junction (GEJ) carcinoma, head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), melanoma, Merkel cell carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors (including MSI-H/dMMR colorectal cancer and endometrial carcinoma), non-small-cell lung cancer (NSCLC), primary mediastinal large B-cell lymphoma (PMBCL), tumor mutational burden-high (TMB-H) solid tumors, and urothelial cancer including non-muscle invasive bladder cancer.

*Keytruda* is also approved for [added: certain] patients with high-risk early stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

In addition, *Keytruda* is approved in combination with chemotherapy for the treatment of certain patients with advanced NSCLC, [removed: in combination with chemotherapy for certain types of] advanced [added: malignant pleural mesothelioma, HNSCC, advanced] biliary tract cancer, [added: advanced esophageal cancer, advanced TNBC, and advanced or recurrent endometrial carcinoma;] in combination with chemotherapy with or without [removed: bevacizumab for advanced cervical cancer,] [added: bevacizumab, and] in combination with [removed: chemotherapy] [added: chemoradiotherapy,] for [added: the treatment of certain patients with] advanced [removed: esophageal cancer,] [added: cervical cancer;] in combination with trastuzumab and chemotherapy for [added: the treatment of] certain patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric or GEJ adenocarcinoma with [removed: PD-L1] [added: programmed death-ligand 1 (PD-L1)] (CPS [removed: ≥1)] [added: ≥1),] and in combination with chemotherapy for [added: the treatment of certain patients with] advanced HER2-negative gastric or GEJ [removed: adenocarcinoma, in combination with chemotherapy for HNSCC, in combination with chemotherapy for advanced TNBC,] [added: adenocarcinoma;] in combination with axitinib for [added: the treatment of certain patients with] advanced [removed: RCC,] [added: RCC;] in combination with Lenvima (lenvatinib) for [added: the treatment of certain] patients with advanced RCC or [removed: certain types of] advanced endometrial [removed: carcinoma,] [added: carcinoma;] and in combination with enfortumab vedotin for [removed: adult] [added: certain] patients with locally advanced or metastatic urothelial cancer.

*Welireg* (belzutifan) is a medication for the treatment of adult patients with certain von Hippel-Lindau [added: (VHL)] disease-associated tumors [added: not requiring immediate surgery,] and for the treatment of adult patients with advanced RCC following a PD-1 or [removed: programmed death-ligand 1 (PD-L1)] [added: PD-L1] inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor.

*Gardasil* (Human Papillomavirus Quadrivalent \[Types 6, 11, 16 and 18\] Vaccine, Recombinant)/*Gardasil* 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), vaccines to help prevent certain cancers and diseases caused by certain types of human papillomavirus (HPV); *ProQuad* (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a pediatric combination vaccine to help protect against measles, mumps, rubella and varicella; *M−M−R* II (Measles, Mumps and Rubella Virus Vaccine Live), a vaccine to help prevent measles, mumps and rubella; *Varivax* (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox (varicella); [removed: *RotaTeq* (Rotavirus Vaccine, Live Oral, Pentavalent), a vaccine to help protect against rotavirus gastroenteritis in infants and children;] *Vaxneuvance* (Pneumococcal 15-valent Conjugate Vaccine), a vaccine to help prevent invasive pneumococcal disease in individuals 6 weeks of age and older; [added: *RotaTeq* (Rotavirus Vaccine, Live Oral, Pentavalent), a vaccine to help protect against rotavirus gastroenteritis in infants and children; and] *Pneumovax* 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal [removed: disease; and *Vaqta* (hepatitis A vaccine, inactivated) indicated for the prevention of disease caused by hepatitis A virus in persons 12 months of age and older.][added: disease.]

*Bridion* (sugammadex), a medication for the reversal of two types of neuromuscular blocking agents used during surgery; *Prevymis* (letermovir) for the prophylaxis of cytomegalovirus (CMV) infection and disease, or of CMV disease, in certain high risk adult [added: and pediatric] recipients of an allogeneic hematopoietic stem cell transplant or of a kidney transplant, respectively; *Dificid* (fidaxomicin) for the treatment of *C. difficile*\-associated diarrhea; *Zerbaxa* (ceftolozane and tazobactam) for injection, a combination antibacterial and beta-lactamase inhibitor for the treatment of certain [added: bacterial infections; and *Noxafil* (posaconazole), an antifungal agent for the prevention of certain invasive fungal infections.]

[added: improve WHO functional class and reduce the risk of clinical worsening events;] Adempas (riociguat), a cardiovascular drug for the treatment of chronic thromboembolic pulmonary hypertension or pulmonary arterial hypertension in certain patients; [added: and] Verquvo (vericiguat), a medicine to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in certain adults with symptomatic chronic heart failure and reduced ejection fraction.

[removed: *Lagevrio*,] [added: *Lagevrio* (molnupiravir),] an investigational oral antiviral COVID-19 medicine available in the U.S. under Emergency Use Authorization (EUA); *Isentress/Isentress HD* (raltegravir), an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 [removed: infection.][added: infection; *Delstrigo* (doravirine/lamivudine/tenofovir disoproxil fumarate), a complete regimen for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history or to replace the current antiretroviral regime in certain patients who are virologically suppressed on a stable antiretroviral regimen; and *Pifeltro* (doravirine), a non-nucleoside reverse transcriptase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history or to replace the current antiretroviral regime in certain patients who are virologically suppressed on a stable antiretroviral regimen.]

*Nuflor* (Florfenicol) antibiotic range for use in cattle and swine; *Bovilis*/*Vista* vaccine lines for infectious diseases in [removed: cattle;] [added: cattle, including *Bovilis Cryptium* for protection against Cryptosporidium parvum;] *Banamine* (Flunixin meglumine) bovine and swine anti-inflammatory; *Estrumate* (cloprostenol sodium) for the treatment of fertility disorders in cattle; *Matrix* (altrenogest) fertility management for swine; *Resflor* (florfenicol and flunixin meglumine)*,* a combination broad-spectrum antibiotic and non-steroidal anti-inflammatory drug for bovine respiratory disease; *Zuprevo* [removed: (Tildipirosin)] [added: (tildipirosin)] for bovine respiratory disease; *Revalor* (trenbolone acetate and estradiol) to improve production efficiencies in beef cattle; *Safe-Guard* (fenbendazole) de-wormer for cattle; *M+Pac* (Mycoplasma Hyopneumoniae Bacterin) swine pneumonia vaccine; *Porcilis* (Lawsonia intracellularis baterin) and *Circumvent* (Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector) vaccine lines for infectious diseases in swine; *Nobilis*/*Innovax* (Live Marek’s Disease Vector)*,* vaccine lines for poultry; *Paracox* and *Coccivac* coccidiosis vaccines; *Exzolt*, a systemic treatment for poultry red mite infestations; *Slice* [removed: (Emamectin] [added: (emamectin] benzoate) parasiticide [added: and *Imvixa* (lufenuron)] for sea lice [added: control] in salmon; [added: *Clynav* vaccine for protection against pancreas disease in salmon;] *Aquavac* (Avirulent Live Culture)/*Norvax* vaccines against bacterial and viral disease in fish; *Aquaflor* [removed: (Florfenicol)] [added: (florfenicol)] antibiotic for farm-raised fish; *Flexolt* (fluralaner) against lice in sheep; and *Allflex Livestock Intelligence* solutions for animal identification, monitoring and traceability.

*Bravecto*, a line of [removed: oral and] [added: oral,] topical [added: and injectable] parasitic control products, including the original *Bravecto* (fluralaner) products for dogs and cats that last up to 12 weeks; *Bravecto* (fluralaner) *One-Month*, a monthly product for dogs, [added: *Bravecto* (fluralaner) *Injectable/Quantum*, an injectable product for dogs that lasts up to one-year,] and *Bravecto Plus* (fluralaner/moxidectin), a two-month product for cats; *Sentinel,* a line of oral parasitic products for dogs including *Sentinel Spectrum* (milbemycin oxime, lufenuron, and praziquantel) and *Sentinel Flavor Tabs* (milbemycin oxime, lufenuron); *Optimmune* (cyclosporine), an ophthalmic ointment; *Nobivac* vaccine lines for flexible dog and cat [removed: vaccination;] [added: vaccination, including *Nobivac NXT* for canine flu and feline leukemia virus;] *GilvetMab*, an immune checkpoint inhibitor monoclonal antibody conditionally licensed for melanoma and mastocytoma tumors; *Otomax* [removed: (Gentamicin] [added: (gentamicin] sulfate, USP; Betamethasone valerate USP; and Clotrimazole USP ointment)/*Mometamax* [removed: (Gentamicin] [added: (gentamicin] sulfate, USP, Mometasone Furoate Monohydrate and Clotrimazole, USP, Otic Suspension)/*Mometamax Ultra* (gentamicin sulfate, mometasone furoate monohydrate and posaconazole suspension)/*Posatex* [removed: (Orbifloxacin, Mometasone Furoate Monohydrate] [added: (orbifloxacin, mometasone furoate monohydrate] and [removed: Posaconazole, Suspension)] [added: posaconazole, suspension)] ear ointments for acute and chronic otitis; *Caninsulin*/*Vetsulin* (porcine insulin zinc suspension) diabetes mellitus treatment for dogs and cats; *Panacur* (fenbendazole)/*Safeguard* (fenbendazole) broad-spectrum anthelmintic (de-wormer) for use in many animals; *Regumate* (altrenogest) fertility management for horses; *Prestige* vaccine line [added: for horses; *Scalibor* (Deltamethrin)*/Exspot* for protecting against bites]

[removed: for horses; *Scalibor* (Deltamethrin)*/Exspot* for protecting against bites] from fleas, ticks, mosquitoes and sandflies; and *Sure Petcare* products for companion animal identification and well-being, including the microchip and pet recovery system *Home Again*.

Set forth below is a summary of significant product approvals received by the Company in [removed: 2023] [added: 2024] and, to date, in [removed: 2024.][added: 2025.]

| [removed: April 2023] [added: September 2024] | | | [removed: FDA accelerated] [added: EC] approval in combination with Padcev (enfortumab [removed: vedotin-ejfv)] [added: vedotin-ejfv), an antibody-drug conjugate,] for the [added: first-line] treatment of [removed: adult patients with locally advanced] [added: unresectable] or metastatic urothelial carcinoma [removed: who are not eligible for cisplatin-containing chemotherapy,] [added: in adults,] based on the [removed: KEYNOTE-869] [added: KEYNOTE-A39] trial [removed: dose escalation cohort, Cohort A and Cohort K, which] [added: that] was conducted in collaboration with Seagen (now Pfizer [removed: Inc. (Pfizer))] [added: Inc.)] and Astellas. | | | | | |

| [removed: August 2023] [added: June 2024] | | | [removed: European Commission (EC)] [added: China’s NMPA] approval in combination with trastuzumab, [removed: fluoropyrimidine-] [added: fluoropyrimidine] and platinum-containing [removed: chemotherapy,] [added: chemotherapy] for the first-line treatment of [added: patients with] locally advanced unresectable or metastatic [removed: HER2-positive] [added: HER2 positive] gastric or GEJ adenocarcinoma [removed: in adults] whose tumors express [removed: PD-L1,] [added: PD-L1 as determined by a fully validated test,] based on the KEYNOTE-811 trial. | | | | | |

| [removed: October 2023] [added: March 2024] | | | [removed: EC] [added: European Commission (EC)] approval [added: in combination with platinum-containing chemotherapy] as [removed: a] [added: neoadjuvant treatment, and then continued as] monotherapy [removed: for the] [added: as] adjuvant [removed: treatment of adults with] [added: treatment, for resectable] NSCLC [removed: who are] at high risk of recurrence [removed: following complete resection and platinum-based chemotherapy,] [added: in adults,] based on the [removed: KEYNOTE-091] [added: KEYNOTE-671] trial. | | | | | |

| [removed: October 2023] [added: December 2024] | | | [removed: FDA] [added: China’s NMPA] approval [removed: for the treatment of patients with resectable (tumors >=4cm or node positive) NSCLC] in combination with platinum-containing chemotherapy as neoadjuvant [removed: treatment,] [added: treatment] and then continued as [removed: a single agent] [added: monotherapy] as adjuvant treatment after [removed: surgery,] [added: surgery for patients with resectable stage II, IIIA, or IIIB NSCLC,] based on the KEYNOTE-671 trial. | | | | | |

| [removed: October 2023] [added: May 2024] | | | [removed: FDA] [added: Japan’s MHLW] approval in combination with [removed: gemcitabine] [added: standard of care chemotherapy (gemcitabine] and [removed: cisplatin] [added: cisplatin)] for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer, based on the KEYNOTE-966 trial. | | | | | |

| [removed: *Keytruda* | | | November 2023] [added: May 2024] | | | [removed: FDA] [added: Japan’s Ministry of Health, Labor and Welfare (MHLW)] approval in combination with [removed: fluoropyrimidine-] [added: fluoropyrimidine] and platinum-containing [removed: chemotherapy,] [added: chemotherapy] for the first-line treatment of [removed: adults] [added: patients] with locally advanced unresectable or metastatic [removed: HER2-negative] gastric or GEJ adenocarcinoma, based on the KEYNOTE-859 trial. | | | [added: | | |]

| [removed: December 2023] [added: February 2024] | | | [removed: EC] [added: China’s National Medical Products Administration (NMPA)] approval in combination with gemcitabine and cisplatin for the first-line treatment of [added: patients with] locally advanced [removed: unresectable] or metastatic biliary tract [removed: carcinoma in adults,] [added: carcinoma,] based on the KEYNOTE-966 trial. | | | | | |

| [removed: December 2023] [added: September 2024] | | | [removed: China’s NMPA] [added: FDA] approval in combination with [removed: fluoropyrimidine-] [added: pemetrexed] and [removed: platinum-containing] [added: platinum] chemotherapy for the first-line treatment of [added: adult] patients with [removed: locally advanced] unresectable [added: advanced] or metastatic [removed: HER2-negative gastric or GEJ adenocarcinoma,] [added: malignant pleural mesothelioma,] based on the [removed: KEYNOTE-859] [added: IND.227/KEYNOTE-483] trial. | | | | | |

| [added: *Keytruda* | | |] January 2024 | | | [removed: FDA] [added: U.S. Food and Drug Administration (FDA)] approval in combination with chemoradiotherapy for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) [removed: stage] [added: 2014 Stage] III-IVA cervical cancer, based on the KEYNOTE-A18 trial. | | | [removed: | | |]

| [removed: February 2024] [added: January 2025] | | | China’s NMPA approval in combination with [removed: gemcitabine and cisplatin] [added: Padcev] for [removed: the first-line treatment of] [added: adult] patients with locally advanced or metastatic [removed: biliary tract carcinoma,] [added: urothelial cancer,] based on the [removed: KEYNOTE-966] [added: KEYNOTE-A39] trial. | | | | | |

| *Prevymis* | | | 785 | | | | | | 605 | | | | | | 428 | | |

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| *Keytruda* | | | September 2024 | | | Japan’s MHLW approval in combination with Padcev for the first-line treatment of patients with radically unresectable urothelial carcinoma, based on the KEYNOTE-A39 trial. | | |

| September 2024 | | | Japan’s MHLW approval as monotherapy in patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy, based on the KEYNOTE-052 trial. | | | | | |

| September 2024 | | | China’s NMPA approval for the first-line treatment of adult patients with unresectable or metastatic melanoma, and conversion from conditional to full approval for the second-line treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy, based on the LEAP-003 trial. | | | | | |

| October 2024 | | | EC approval in combination with chemoradiotherapy for the treatment of FIGO 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy, based on the KEYNOTE-A18 trial. | | | | | |

| October 2024 | | | EC approval in combination with carboplatin and paclitaxel followed by *Keytruda* as a single agent for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy, based on the KEYNOTE-868 trial. | | | | | |

| December 2024 | | | China’s NMPA approval in combination with chemoradiotherapy for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer, based on the KEYNOTE-A18 trial. | | | | | |

| *Capvaxive* | | | June 2024 | | | FDA approval for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by certain serotypes in individuals 18 years of age and older. | | |

| *Gardasil* | | | January 2025 | | | China’s NMPA approval for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases. | | |

| *Lynparza(1)* | | | January 2025 | | | China’s NMPA approval for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline *BRCA*\-mutated, HER2-negative high-risk early breast cancer who have been previously treated with neoadjuvant or adjuvant chemotherapy, based on the OlympiA trial. | | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

| *Welireg* | | | November 2024 | | | China’s NMPA approval for the treatment of adult patients with VHL disease who require therapy for associated RCC, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors. | | |

| February 2025 | | | EC conditional approval as monotherapy both for the treatment of adult patients with VHL disease who require therapy for associated, localized RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, and for whom localized procedures are unsuitable, and for the treatment of adult patients with advanced clear cell RCC that progressed following two or more lines of therapy that included a PD-1 or PD-L1 inhibitor and at least two VEGF targeted therapies. The EC approval of these two indications is based on results from the LITESPARK-004 and LITESPARK-005 trials. | | | | | |

| *Winrevair* | | | March 2024 | | | FDA approval for the treatment of adults with PAH (WHO Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. | | |

| August 2024 | | | EC approval in combination with other PAH therapies, for the treatment of PAH in adult patients with WHO FC II to III, to improve exercise capacity. | | | | | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

Additionally, increased utilization of the 340B Federal Drug Discount Program and restrictions on the Company’s ability to identify inappropriate discounts are having a negative impact on Company performance.

Government price setting may also impact pricing in the private market negatively affecting the Company’s performance.

In January 2025, HHS announced that *Janumet* and *Janumet XR* have been selected for government price setting, which will become effective on January 1, 2027.

In addition, the Company expects that *Keytruda* will be selected in 2026 for government price setting, which would become effective on January 1, 2028 and the Company expects that, as a result, U.S. sales of *Keytruda* will decline after that time.

Furthermore,

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[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

which it is conducted.

The EU Health Technology Assessment Regulation 2021/2282 (HTAR) applies in 2025.

This provides for the conduct of an EU level comparative Joint Clinical Assessment (JCA) of a new product versus relevant comparators identified by the EU Member States.

JCAs will be carried out in parallel with the review of a marketing authorization application, so that a JCA report is available shortly after the product is authorized.

The HTAR applies to all new active substance oncology products and advanced therapy medicinal products, including cell and gene therapies, beginning January 1, 2025; to new active substance orphan medicinal products beginning January 1, 2028; and to all products approved via the centralized procedure beginning in 2030.

EU Member States remain responsible for pricing and reimbursement decisions but must take “due consideration” of JCA reports when making national market access decisions.

This means that EU Member State pricing and reimbursement processes are likely to evolve and more EU Member States may use HTAs as part of their decision-making.

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

and patient levels.

The uncertainty regarding the interplay between

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

Patents may not only cover a product *per se*, but also pharmaceutical formulations of a product, processes for making a product, including intermediates useful in those processes, and methods of treatment or other uses of a product.

On June 2, 2021, Merck completed the spin-off (the Spin-Off) of products from its women’s health, biosimilars and established brands businesses into a new, independent, publicly traded company named Organon & Co. (Organon) through a distribution of Organon’s publicly traded stock to Company shareholders.

The established brands included in the transaction consisted of dermatology, non-opioid pain management, respiratory, select cardiovascular products, as well as the rest of Merck’s diversified brands franchise.

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

bacterial infections; *Noxafil* (posaconazole), an antifungal agent for the prevention of certain invasive fungal infections; and *Primaxin* (imipenem and cilastatin) for injection, an antibiotic for the treatment of certain bacterial infections.

Immunology

*Simponi* (golimumab), a once-monthly subcutaneous treatment for certain inflammatory diseases; and *Remicade* (infliximab), a treatment for inflammatory diseases, both of which the Company markets in Europe, Russia and Türkiye.

| *Keytruda* | | | January 2023 | | | U.S. Food and Drug Administration (FDA) approval as a single agent for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC, based on the KEYNOTE-091 trial. | | |

| March 2023 | | | FDA full approval for the treatment of adult and pediatric patients with unresectable or metastatic MSI-H or dMMR solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. The conversion from an accelerated to a full (regular) approval is based on the KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 trials. | | | | | |

| June 2023 | | | Japan’s Ministry of Health, Labor and Welfare (MHLW) approval for the treatment of patients with relapsed or refractory PMBCL, based on the KEYNOTE-170 and the KEYNOTE-A33 trials. | | | | | |

| September 2023 | | | China’s National Medical Products Administration (NMPA) approval as monotherapy for the treatment of adult patients with advanced unresectable or metastatic MSI-H or dMMR solid tumors, including patients with colorectal cancer that have progressed following treatment with fluoropyrimidine, oxaliplatin or irinotecan, or those with other solid tumors that have progressed following prior therapy and who have no satisfactory alternative treatment options, based on the KEYNOTE-158 and KEYNOTE-164 trials. | | | | | |

| October 2023 | | | FDA full approval for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The conversion from an accelerated to a full (regular) approval is based on the KEYNOTE-913 and KEYNOTE-017 trials. | | | | | |

| December 2023 | | | FDA full approval in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. The conversion from an accelerated to a full (regular) approval is based on the KEYNOTE-A39 trial that was conducted in collaboration with Seagen (now Pfizer) and Astellas. | | | | | |

| December 2023 | | | EC approval in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma in adults whose tumors express PD-L1, based on the KEYNOTE-859 trial. | | | | | |

| Lynparza*(1)* | | | May 2023 | | | FDA approval in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious *BRCA-mutated* (*BRCAm*) metastatic castration-resistant prostate cancer (mCRPC), based on the PROpel trial. | | |

| *Prevymis* | | | June 2023 | | | FDA approval for CMV prophylaxis in Donor CMV-seropositive/Recipient CMV-seronegative adult kidney transplant recipients, based on the P002 trial. | | |

| November 2023 | | | EC approval for CMV prophylaxis Donor CMV-seropositive/Recipient CMV-seronegative adult kidney transplant recipients, based on the P002 trial. | | | | | |

| *Ervebo* | | | August 2023 | | | FDA approval of an expanded indication for the prevention of disease caused by *Zaire ebolavirus* in individuals 12 months of age and older. The vaccine was previously approved for use in individuals 18 years of age and older. | | |

| September 2023 | | | EC approval of an expanded indication for active immunization of individuals one year of age or older to protect against Ebola Virus Disease caused by *Zaire ebolavirus*. The vaccine was previously approved for use in the EU for individuals 18 years of age or older. | | | | | |

| *Welireg* | | | December 2023 | | | FDA approval for the treatment of adult patients with advanced RCC following both a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor, based on the LITESPARK-005 trial. | | |

In addition to formulary

In order to provide information about the Company’s pricing practices, the Company annually posts on its website its Pricing Transparency Report for the U.S. The report provides the Company’s average annual list price, net price increases, and average discounts across the Company’s U.S. portfolio dating back to 2010.

In 2023, the Company’s gross U.S. sales were reduced by 37% as a result of rebates, discounts and returns.

regulatory review process for medicines with this designation.

It also imposes a number of strict obligations and restrictions on the

Patents may cover products *per se*, pharmaceutical formulations, processes for, or intermediates useful in, the manufacture of products, or the uses of products.

| *Simponi* | | | N/A*(6)* | | | | | | 2024*(7)* | | | | | | N/A*(6)* | | | | | | N/A*(6)* | | |

| *Bravecto* | | | 2026 (with pending PTE) | | | | | | 2029 | | | | | | 2029 | | | | | | 2025 | | |

| *Zerbaxa* | | | 2028*(9)* | | | | | | 2028*(9)* | | | | | | 2028 | | | | | | N/A | | |

| *Prevymis* | | | 2029*(9)* (with pending PTE) | | | | | | 2029*(9)* | | | | | | 2029 | | | | | | 2024 | | |

| *Delstrigo* | | | 2032 (with pending PTE) | | | | | | 2033*(9)* | | | | | | N/A | | | | | | 2031 | | |

| *Pifeltro* | | | 2032 (with pending PTE) | | | | | | 2033*(9)* | | | | | | 2036 | | | | | | 2031 | | |

*(6)The Company has no marketing rights in the U.S., Japan or China.*

*(7)The distribution agreement with Johnson & Johnson Innovative Medicine expires on October 1, 2024.*

| MK-7264 (gefapixant)*(1)* | | | 2027 | | |

| MK-7962 (sotatercept) | | | 2027*(2)* | | |

| V116 (pneumococcal vaccine) | | | 2038 | | |

*(1)* *Received a Complete Response Letter from the FDA in December 2023.*

| MK-7684A (vibostolimab + pembrolizumab) | | | 2035 | | |

| MK-4280A (favezelimab + pembrolizumab) | | | 2035 | | |

| V940*(1)* | | | 2035 | | |

“Financial Statements and Supplementary Data,” Note [removed: 11.][added: 10.]

“Contingencies and Environmental [removed: Liabilities”.][added: Liabilities.”]

As filed with the Securities and Exchange Commission on February [removed: 26, 2024][added: 25, 2025]

For the Fiscal Year Ended December 31, [removed: 2023][added: 2024]

[removed: ][added: ]

| [removed: 0.500%] [added: 3.250%] Notes due [removed: 2024] [added: 2032] | | | [removed: MRK 24] [added: MRK/32] | | | New York Stock Exchange | | |

| [added: Large accelerated filer | | | ☒ | | | Accelerated filer | | | ☐ | | |] Non-accelerated filer | | | ☐ | | | Smaller reporting company | | | ☐ | | | [added: Emerging growth company | | | ☐ | | |]

Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, [removed: 2024: 2,532,643,872.][added: 2025: 2,526,036,240.]

Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June [removed: 30, 2023] [added: 28, 2024] based on the closing price on June [removed: 30, 2023: $292,929,000,000.][added: 28, 2024, the last business day of the registrant’s most recently completed second fiscal quarter: approximately $313,799,000,000.]

| Proxy Statement for the Annual Meeting of Shareholders to be held May [removed: 18, 2024,] [added: 27, 2025,] to be filed with the Securities and Exchange Commission within 120 days after the close of the fiscal year covered by this report | | | | | | Part III | | |

| Item 1. | | | [removed: [Business](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_13)] [added: [Business](#i783cf867b028427ba2fa2dcfd656c4d4_13)] | | | | | | [removed: [1](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_13)] [added: [1](#i783cf867b028427ba2fa2dcfd656c4d4_13)] | | |

| Item 1A. | | | [Risk [removed: Factors](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_49)] [added: Factors](#i783cf867b028427ba2fa2dcfd656c4d4_49)] | | | | | | [removed: [25](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_49)] [added: [26](#i783cf867b028427ba2fa2dcfd656c4d4_49)] | | |

| | | | [Cautionary Factors that May Affect Future [removed: Results](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_52)] [added: Results](#i783cf867b028427ba2fa2dcfd656c4d4_52)] | | | | | | [removed: [38](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_52)] [added: [40](#i783cf867b028427ba2fa2dcfd656c4d4_52)] | | |

| Item 1B. | | | [Unresolved Staff [removed: Comments](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_55)] [added: Comments](#i783cf867b028427ba2fa2dcfd656c4d4_55)] | | | | | | [removed: [39](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_55)] [added: [41](#i783cf867b028427ba2fa2dcfd656c4d4_55)] | | |

| Item 1C. | | | [removed: [Cybersecurity](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_2135)] [added: [Cybersecurity](#i783cf867b028427ba2fa2dcfd656c4d4_58)] | | | | | | [removed: [39](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_2135)] [added: [41](#i783cf867b028427ba2fa2dcfd656c4d4_58)] | | |

| Item 2. | | | [removed: [Properties](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_58)] [added: [Properties](#i783cf867b028427ba2fa2dcfd656c4d4_61)] | | | | | | [removed: [40](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_58)] [added: [41](#i783cf867b028427ba2fa2dcfd656c4d4_61)] | | |

| Item 3. | | | [Legal [removed: Proceedings](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_61)] [added: Proceedings](#i783cf867b028427ba2fa2dcfd656c4d4_64)] | | | | | | [removed: [40](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_61)] [added: [42](#i783cf867b028427ba2fa2dcfd656c4d4_64)] | | |

| Item 4. | | | [Mine Safety [removed: Disclosures](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_64)] [added: Disclosures](#i783cf867b028427ba2fa2dcfd656c4d4_67)] | | | | | | [removed: [40](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_64)] [added: [42](#i783cf867b028427ba2fa2dcfd656c4d4_67)] | | |

| | | | [Executive Officers of the [removed: Registrant](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_67)] [added: Registrant](#i783cf867b028427ba2fa2dcfd656c4d4_70)] | | | | | | [removed: [41](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_67)] [added: [43](#i783cf867b028427ba2fa2dcfd656c4d4_70)] | | |

| Item 5. | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_73)] [added: Securities](#i783cf867b028427ba2fa2dcfd656c4d4_76)] | | | | | | [removed: [42](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_73)] [added: [44](#i783cf867b028427ba2fa2dcfd656c4d4_76)] | | |

| Item 6. | | | [removed: [\[Reserved\]](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_76)] [added: [\[Reserved\]](#i783cf867b028427ba2fa2dcfd656c4d4_79)] | | | | | | [removed: [43](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_76)] [added: [45](#i783cf867b028427ba2fa2dcfd656c4d4_79)] | | |

| Item 7. | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_79)] [added: Operations](#i783cf867b028427ba2fa2dcfd656c4d4_82)] | | | | | | [removed: [44](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_79)] [added: [46](#i783cf867b028427ba2fa2dcfd656c4d4_82)] | | |

| Item 7A. | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_121)] [added: Risk](#i783cf867b028427ba2fa2dcfd656c4d4_124)] | | | | | | [removed: [70](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_121)] [added: [74](#i783cf867b028427ba2fa2dcfd656c4d4_124)] | | |

| Item 8. | | | [Financial Statements and Supplementary [removed: Data](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_124)] [added: Data](#i783cf867b028427ba2fa2dcfd656c4d4_127)] | | | | | | [removed: [71](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_124)] [added: [75](#i783cf867b028427ba2fa2dcfd656c4d4_127)] | | |

| | | | | | | [Notes to Consolidated Financial [removed: Statements](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_142)] [added: Statements](#i783cf867b028427ba2fa2dcfd656c4d4_145)] | | | [removed: [75](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_142)] [added: [79](#i783cf867b028427ba2fa2dcfd656c4d4_145)] | | |

| | | | | | | [Report of Independent Registered Public Accounting [removed: Firm](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_208)] [added: Firm](#i783cf867b028427ba2fa2dcfd656c4d4_211)] | | | [removed: [127](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_208)] [added: [131](#i783cf867b028427ba2fa2dcfd656c4d4_211)] | | |

| Item 9. | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_211)] [added: Disclosure](#i783cf867b028427ba2fa2dcfd656c4d4_214)] | | | | | | [removed: [129](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_211)] [added: [133](#i783cf867b028427ba2fa2dcfd656c4d4_214)] | | |

| Item 9A. | | | [Controls and [removed: Procedures](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_214)] [added: Procedures](#i783cf867b028427ba2fa2dcfd656c4d4_217)] | | | | | | [removed: [129](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_214)] [added: [133](#i783cf867b028427ba2fa2dcfd656c4d4_217)] | | |

| Item 9B. | | | [Other [removed: Information](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_220)] [added: Information](#i783cf867b028427ba2fa2dcfd656c4d4_223)] | | | | | | [removed: [130](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_220)] [added: [134](#i783cf867b028427ba2fa2dcfd656c4d4_223)] | | |

| Item 9C. | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_223)] [added: Inspections](#i783cf867b028427ba2fa2dcfd656c4d4_226)] | | | | | | [removed: [130](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_223)] [added: [134](#i783cf867b028427ba2fa2dcfd656c4d4_226)] | | |

| Item 10. | | | [Directors, Executive Officers and Corporate [removed: Governance](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_229)] [added: Governance](#i783cf867b028427ba2fa2dcfd656c4d4_232)] | | | | | | [removed: [131](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_229)] [added: [135](#i783cf867b028427ba2fa2dcfd656c4d4_232)] | | |

| Item 11. | | | [Executive [removed: Compensation](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_232)] [added: Compensation](#i783cf867b028427ba2fa2dcfd656c4d4_235)] | | | | | | [removed: [131](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_232)] [added: [135](#i783cf867b028427ba2fa2dcfd656c4d4_235)] | | |

| Item 12. | | | [Security Ownership of Certain Beneficial Owners and Management and [removed: Related](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_235)[ ](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_235)[Stockholder Matters](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_235)] [added: Related](#i783cf867b028427ba2fa2dcfd656c4d4_238)[ ](#i783cf867b028427ba2fa2dcfd656c4d4_238)[Stockholder Matters](#i783cf867b028427ba2fa2dcfd656c4d4_238)] | | | | | | [removed: [132](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_235)] [added: [136](#i783cf867b028427ba2fa2dcfd656c4d4_238)] | | |

| Item 13. | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_238)] [added: Independence](#i783cf867b028427ba2fa2dcfd656c4d4_241)] | | | | | | [removed: [132](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_238)] [added: [136](#i783cf867b028427ba2fa2dcfd656c4d4_241)] | | |

| Item 14. | | | [Principal Accountant Fees and [removed: Services](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_241)] [added: Services](#i783cf867b028427ba2fa2dcfd656c4d4_244)] | | | | | | [removed: [132](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_241)] [added: [136](#i783cf867b028427ba2fa2dcfd656c4d4_244)] | | |

| Item 15. | | | [Exhibits and Financial Statement [removed: Schedules](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_247)] [added: Schedules](#i783cf867b028427ba2fa2dcfd656c4d4_250)] | | | | | | [removed: [133](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_247)] [added: [137](#i783cf867b028427ba2fa2dcfd656c4d4_250)] | | |

| Item 16. | | | [Form 10-K [removed: Summary](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_259)] [added: Summary](#i783cf867b028427ba2fa2dcfd656c4d4_262)] | | | | | | [removed: [137](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_259)] [added: [141](#i783cf867b028427ba2fa2dcfd656c4d4_262)] | | |

| 3.500% Notes due 2037 | | | MRK/37 | | | New York Stock Exchange | | |

| 3.700% Notes due 2044 | | | MRK/44 | | | New York Stock Exchange | | |

| 3.750% Notes due 2054 | | | MRK/54 | | | New York Stock Exchange | | |

| Securities Registered pursuant to Section 12(g) of the Act: None | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | | | | | | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

| [Part I](#i783cf867b028427ba2fa2dcfd656c4d4_10) | | | | | | | | | | | |

| [Part II](#i783cf867b028427ba2fa2dcfd656c4d4_73) | | | | | | | | | | | |

| | | | (a) | | | [Financial Statements](#i783cf867b028427ba2fa2dcfd656c4d4_130) | | | [75](#i783cf867b028427ba2fa2dcfd656c4d4_130) | | |

| | | | [Management’s Report](#i783cf867b028427ba2fa2dcfd656c4d4_220) | | | | | | [133](#i783cf867b028427ba2fa2dcfd656c4d4_220) | | |

| [Part III](#i783cf867b028427ba2fa2dcfd656c4d4_223) | | | | | | | | | | | |

| [Part IV](#i783cf867b028427ba2fa2dcfd656c4d4_247) | | | | | | | | | | | |

| | | | [Signatures](#i783cf867b028427ba2fa2dcfd656c4d4_265) | | | | | | [142](#i783cf867b028427ba2fa2dcfd656c4d4_265) | | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

| | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Large accelerated filer | | | ☒ | | | Accelerated filer | | | ☐ | | |

| | | | | | | Emerging growth company | | | ☐ | | |

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

| [Part I](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_10) | | | | | | | | | | | |

| [Part II](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_70) | | | | | | | | | | | |

| | | | (a) | | | [Financial Statements](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_127) | | | [71](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_127) | | |

| | | | [Management’s Report](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_217) | | | | | | [129](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_217) | | |

| [Part III](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_220) | | | | | | | | | | | |

| [Part IV](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_244) | | | | | | | | | | | |

| | | | [Signatures](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_262) | | | | | | [138](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_262) | | |

The Company’s cybersecurity measures are primarily focused on ensuring the security and protection of its [removed: information technology] [added: IT] systems and data.

[added: The information security program is regularly evaluated by internal and external consultants and auditors] with the results of those reviews reported to senior management and the Audit Committee, which is comprised entirely of independent directors and has oversight responsibility for these risks.

As part of this program, the Company conducts periodic tabletop [added: and red-teaming] exercises to assess its cybersecurity incident response [removed: processes.][added: processes and defenses.]

In the event of a cybersecurity incident, the Company has a process in place whereby members of the [added: information] security group will alert the CISO and the CISO will alert the appropriate levels of management, including an incident assessment team, as well as the legal and finance departments so that the materiality of any such event can be assessed in furtherance of fulfilling any reporting requirements.

The information security program is regularly evaluated by internal and external consultants and auditors

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

Principal U.S. research facilities are located in [removed: Rahway and Kenilworth,] [added: Rahway,] New Jersey; West Point, Pennsylvania; Boston and Cambridge, Massachusetts; South San Francisco, California; and Elkhorn, Nebraska (Animal Health).

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

Executive Officers of the Registrant (ages as of February 1, [removed: 2024)][added: 2025)]

| Robert M. Davis | | | [removed: 57] [added: 58] | | | Chairman, Chief Executive Officer and President (since December 2022); Chief Executive Officer and President (July 2021-December 2022); Executive Vice President, Global Services, and Chief Financial Officer (April 2016-July 2021) | | |

| Sanat Chattopadhyay | | | [removed: 64] [added: 65] | | | Executive Vice President and President, Merck Manufacturing Division (since March 2016) | | |

| Richard R. DeLuca, Jr. | | | [removed: 61] [added: 62] | | | Executive Vice President and President, Merck Animal Health (since September 2011) | | |

| Cristal Downing | | | [removed: 55] [added: 56] | | | Executive Vice President and Chief Communications & Public Affairs Officer (since August 2021); Prior to that, Vice President Medical Devices, Global Communications and Public Affairs Johnson & Johnson (December 2020-August 2021); Vice President Financial Communication, Johnson & Johnson (January 2018-December 2020) | | |

| Chirfi Guindo | | | [removed: 58] [added: 59] | | | Senior Vice President, Chief Marketing Officer, Human Health (since July 2022); Prior to that, Executive Vice President, Head of Global Product Strategy and Commercialization, Biogen Inc. (July 2018-July 2022) | | |

| Dean Li | | | [removed: 61] [added: 62] | | | Executive Vice President, President, Merck Research Laboratories (since January 2021); Senior Vice President, Discovery Sciences and Translational Medicine, Merck Research Laboratories (November 2017-January 2021) | | |

| Caroline Litchfield | | | [removed: 55] [added: 56] | | | Executive Vice President and Chief Financial Officer (since April 2021); Senior Vice President, Corporate Treasurer (January 2018-March 2021) | | |

| Johannes J. Oosthuizen | | | [removed: 56] [added: 57] | | | Senior Vice President and President Merck U.S. Human Health (since January 2022); Senior Vice President and Head of Global Oncology Commercial (January 2021-December 2021); Senior Vice President and President of MSD K.K. (July 2016-December 2020) | | |

| Joseph Romanelli | | | [removed: 50] [added: 51] | | | Senior Vice President and President MSD International Human Health (since July 2022); Prior to that, Chief Executive Officer JiXing Pharmaceuticals (July 2021-July 2022); President MSD China (December 2016-July 2021) | | |

| Dalton Smart | | | [removed: 57] [added: 58] | | | Senior Vice President Finance – Global Controller (since December 2023); Vice President, Assistant Controller (September 2023-December 2023); Vice President, Internal Audit (March 2015-September 2023) | | |

| David M. Williams | | | [removed: 55] [added: 56] | | | Executive Vice President, Chief Information and Digital Officer (since August 2020); Acting Chief Information and Digital Officer (December 2019-August [removed: 2020); Vice President and Chief Information Officer, Merck Animal Health (May 2017-December 2019)] [added: 2020)] | | |

| Jennifer Zachary | | | [removed: 46] [added: 47] | | | Executive Vice President and General Counsel (since April 2018) | | |

| Betty D. Larson | | | [removed: 48] [added: 49] | | | [added: Executive Vice President and] Chief [added: Human Resources Officer (since April 2024); Prior to that, Chief] People Officer, GE HealthCare [removed: (since February 2022);] [added: (February 2022-April 2024);] Executive Vice President and Chief Human Resources Officer, Becton Dickinson (June 2018-February 2022) | | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Name | | | Age | | | Offices and Business Experience | | |

| Michael A. Klobuchar | | | 48 | | | Executive Vice President, Chief Strategy Officer (since July 2021); Senior Vice President, CFO of Merck R&D and Head of Global Portfolio and Alliance Management (January 2019-June 2021) | | |

| Steven C. Mizell | | | 63 | | | Executive Vice President, Chief Human Resources Officer (since October 2018) | | |

On February 1, 2024, the Company announced that Steven C.

Mizell, chief human resources officer, will retire from the Company, effective July 1, 2024.

On February 5, 2024, the Company announced that Ms. Betty D.

Larson will join the Company and assume the role as chief human resources officer, effective at the beginning of April 2024, at which time Ms. Larson will become, and Mr. Mizell will cease to be, an Executive Officer of the Company.

Mr. Mizell will remain in a strategic advisory role at the Company until his retirement.

As of January 31, [removed: 2024,] [added: 2025,] there were approximately [removed: 90,400] [added: 85,700] shareholders of record of the Company’s Common Stock.

Issuer purchases of equity securities for the three months ended December 31, [removed: 2023] [added: 2024] were as follows:

*(1)* *All shares purchased during the period were made as part of a plan approved by the Board of Directors in October 2018 to purchase up to $10 billion in Merck shares for its [removed: treasury.*][added: treasury.]

The following graph assumes a $100 investment on December 31, [removed: 2018,] [added: 2019,] and reinvestment of all dividends, in each of the Company’s Common Stock, the S&P 500 Index, and a composite peer group of major U.S. and European-based pharmaceutical companies, which are: AbbVie Inc., Amgen Inc., AstraZeneca plc, Bristol-Myers Squibb Company, Johnson & Johnson, Eli Lilly and Company, Gilead Sciences Inc., GlaxoSmithKline plc, Novartis AG, Pfizer Inc., Roche Holding AG, and Sanofi SA.

| | | | End of Period Value | | | | | | [removed: 2023/2018] [added: 2024/2019] CAGR* | | |

| PEER GROUP | | | [removed: 171] [added: 154] | | | | | | [removed: 11%] [added: 9%] | | |

[removed: ][added: ]

| | | | [removed: 2018 | | |] 2019 | | | 2020 | | | 2021 | | | 2022 | | | 2023 | | | [added: 2024 | | |]

* Peer group average was calculated on a market cap weighted basis as of December 31, [removed: 2018.*][added: 2019.*]

| October 1 — October 31 | | | | | | 2,428,680 | | | | | | $108.45 | | | | | | 2,428,680 | | | | | | $2,620 | | |

| November 1 — November 30 | | | | | | 993,250 | | | | | | $99.29 | | | | | | 993,250 | | | | | | $2,522 | | |

| December 1 — December 31 | | | | | | 1,215,000 | | | | | | $99.51 | | | | | | 1,215,000 | | | | | | $2,401 | | |

| Total | | | | | | 4,636,930 | | | | | | $104.15 | | | | | | 4,636,930 | | | | | | | | |

In January 2025, the Board of Directors approved a plan to purchase up to an additional $10 billion in Merck shares for its treasury.*

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

| MERCK | | | $134 | | | | | | 6% | | |

| S&P 500 | | | 197 | | | | | | 15% | | |

| MERCK | | | $ | 100.0 | | $ | 92.8 | | $ | 94.5 | | $ | 141.1 | | $ | 142.5 | | $ | 133.6 | |

| PEER GROUP | | | 100.0 | | | 106.5 | | | 130.4 | | | 138.1 | | | 142.0 | | | 153.7 | | |

| S&P 500 | | | 100.0 | | | 118.4 | | | 152.3 | | | 124.7 | | | 157.5 | | | 196.8 | | |

| October 1 — October 31 | | | | | | 1,309,424 | | | | | | $103.26 | | | | | | 1,309,424 | | | | | | $3,959 | | |

| November 1 — November 30 | | | | | | 1,395,457 | | | | | | $102.30 | | | | | | 1,395,457 | | | | | | $3,816 | | |

| December 1 — December 31 | | | | | | 1,100,500 | | | | | | $104.84 | | | | | | 1,100,500 | | | | | | $3,701 | | |

| Total | | | | | | 3,805,381 | | | | | | $103.36 | | | | | | 3,805,381 | | | | | | | | |

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

| MERCK | | | $174 | | | | | | 12% | | |

| S&P 500 | | | 207 | | | | | | 16% | | |

| MERCK | | | 100.0 | | | 122.3 | | | 113.4 | | | 115.5 | | | 172.5 | | | 174.3 | | |

| PEER GROUP | | | 100.0 | | | 118.5 | | | 126.5 | | | 155.4 | | | 164.6 | | | 171.2 | | |

| S&P 500 | | | 100.0 | | | 131.5 | | | 155.6 | | | 200.3 | | | 164.0 | | | 207.0 | | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

The consolidated balance sheet of Merck & Co., Inc. and subsidiaries as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] and the related consolidated statements of income, of comprehensive [removed: (loss) income,] [added: income (loss),] of equity and of cash flows for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] the notes to consolidated financial statements, and the report dated February [removed: 26, 2024] [added: 25, 2025] of PricewaterhouseCoopers LLP, independent registered public accounting firm, are as follows:

| | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |

| Sales | | | $ | [removed: 60,115] [added: 64,168] | | | | | $ | [removed: 59,283] [added: 60,115] | | | | | $ | [removed: 48,704] [added: 59,283] | |

| Cost of sales | | | [removed: 16,126] [added: 15,193] | | | | | | [removed: 17,411] [added: 16,126] | | | | | | [removed: 13,626] [added: 17,411] | | |

| Selling, general and administrative | | | [removed: 10,504] [added: 10,816] | | | | | | [removed: 10,042] [added: 10,504] | | | | | | [removed: 9,634] [added: 10,042] | | |

| Research and development | | | [removed: 30,531] [added: 17,938] | | | | | | [removed: 13,548] [added: 30,531] | | | | | | [removed: 12,245] [added: 13,548] | | |

| Restructuring costs | | | [removed: 599] [added: 309] | | | | | | [removed: 337] [added: 599] | | | | | | [removed: 661] [added: 337] | | |

| Other (income) expense, net | | | [removed: 466] [added: (24)] | | | | | | [removed: 1,501] [added: 466] | | | | | | [removed: (1,341)] [added: 1,501] | | |

| | | | [removed: 58,226] [added: 44,232] | | | | | | [removed: 42,839] [added: 58,226] | | | | | | [removed: 34,825] [added: 42,839] | | |

| Income [removed: from Continuing Operations] Before Taxes | | | [removed: 1,889] [added: 19,936] | | | | | | [removed: 16,444] [added: 1,889] | | | | | | [removed: 13,879] [added: 16,444] | | |

| Taxes on Income [removed: from Continuing Operations] | | | [removed: 1,512] [added: 2,803] | | | | | | [removed: 1,918] [added: 1,512] | | | | | | [removed: 1,521] [added: 1,918] | | |

| Net Income [removed: from Continuing Operations] | | | [removed: 377] [added: 17,133] | | | | | | [removed: 14,526] [added: 377] | | | | | | [removed: 12,358] [added: 14,526] | | |

| Less: Net Income Attributable to Noncontrolling Interests | | | [removed: 12] [added: 16] | | | | | | [removed: 7] [added: 12] | | | | | | [removed: 13] [added: 7] | | |

| Net Income [removed: from Continuing Operations] Attributable to Merck & Co., Inc. | | | [removed: 365] [added: $] | [added: 17,117] | | | | | [removed: 14,519] [added: $] | [added: 365] | | | | | [removed: 12,345] [added: $] | [added: 14,519] | |

| [removed: Income from Discontinued Operations,] Net [removed: of Taxes and Amounts Attributable] [added: income attributable] to [removed: Noncontrolling Interests] [added: noncontrolling interests] | | | [removed: —] [added: —] | | | | | | — | | | | | | [removed: 704] [added: —] | | | [added: | | | — | | | | | | — | | | | | | 12 | | | | | | 12 | | |]

| Net Income Attributable to Merck & Co., Inc. | | | $ | [removed: 365] [added: 17,117] | | | | | $ | [removed: 14,519] [added: 365] | | | | | $ | [removed: 13,049] [added: 14,519] | |

| Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders | | | [added: $] | [added: 6.76] | | | | | [added: $] | [added: 0.14] | | | | | [added: $] | [added: 5.73] | |

| Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders | | | [added: $] | [added: 6.74] | | | | | [added: $] | [added: 0.14] | | | | | [added: $] | [added: 5.71] | |

Consolidated Statement of Comprehensive [removed: (Loss) Income][added: Income (Loss)]

| Other Comprehensive [removed: (Loss)] Income [added: (Loss)] Net of Taxes: | | | | | | | | | | | | | | | | | |

| Net unrealized [added: income] (loss) [removed: gain] on derivatives, net of reclassifications | | | [removed: (97)] [added: 266] | | | | | | [removed: (71)] [added: (97)] | | | | | | [removed: 410] [added: (71)] | | |

| Benefit plan net [removed: (loss)] gain [added: (loss)] and prior service [removed: (cost) credit,] [added: credit (cost),] net of amortization | | | [removed: (385)] [added: 466] | | | | | | [removed: 335] [added: (385)] | | | | | | [removed: 1,769] [added: 335] | | |

| Cumulative translation adjustment | | | [removed: 89] [added: (516)] | | | | | | [removed: (603)] [added: 89] | | | | | | [removed: (423)] [added: (603)] | | |

| | | | [removed: (393)] [added: 216] | | | | | | [removed: (339)] [added: (393)] | | | | | | [removed: 1,756] [added: (339)] | | |

| Comprehensive [removed: (Loss)] Income [added: (Loss)] Attributable to Merck & Co., Inc. | | | $ | [removed: (28)] [added: 17,333] | | | | | $ | [removed: 14,180] [added: (28)] | | | | | $ | [removed: 14,805] [added: 14,180] | |

| | | | [removed: 2023] [added: 2024] | | | | | | [added: 2023 | | | | | |] 2022 | | |

| Cash and cash equivalents | | | $ | [removed: 6,841] [added: 13,242] | | | | | $ | [removed: 12,694] [added: 6,841] | |

| Short-term investments | | | [removed: 252] [added: 447] | | | | | | [removed: 498] [added: 252] | | |

| Accounts receivable (net of allowance for doubtful accounts of [removed: $88] [added: $89] in [removed: 2023] [added: 2024] and [removed: $72] [added: $88] in [removed: 2022)] [added: 2023)] | | | [removed: 10,349] [added: 10,278] | | | | | | [removed: 9,450] [added: 10,349] | | |

| Inventories (excludes inventories of [removed: $3,348] [added: $4,193] in [removed: 2023] [added: 2024] and [removed: $2,938] [added: $3,348] in [removed: 2022] [added: 2023] classified in Other assets - see Note [removed: 8)] [added: 7)] | | | [removed: 6,358] [added: 6,109] | | | | | | [removed: 5,911] [added: 6,358] | | |

| Other current assets | | | [removed: 8,368] [added: 8,706] | | | | | | [removed: 7,169] [added: 8,368] | | |

| Total current assets | | | [removed: 32,168] [added: 38,782] | | | | | | [removed: 35,722] [added: 32,168] | | |

| Investments | | | [removed: 252] [added: 463] | | | | | | [removed: 1,015] [added: 252] | | |

| Land | | | [removed: 326] [added: 307] | | | | | | [removed: 295] [added: 326] | | |

| Buildings | | | [removed: 14,966] [added: 16,360] | | | | | | [removed: 13,166] [added: 14,966] | | |

| Machinery, equipment and office furnishings | | | [removed: 17,763] [added: 18,283] | | | | | | [removed: 16,760] [added: 17,763] | | |

| Construction in progress | | | [removed: 8,262] [added: 7,984] | | | | | | [removed: 9,186] [added: 8,262] | | |

| Less: accumulated depreciation | | | [removed: 18,266] [added: 19,155] | | | | | | [removed: 17,985] [added: 18,266] | | |

| | | | [removed: 23,051] [added: $] | [added: 23,779] | | | | | [removed: 21,422] [added: $] | [added: 23,051] | | [added: | | | $ | 21,422 | |]

| Goodwill | | | [removed: 21,197] [added: 21,668] | | | | | | [removed: 21,204] [added: 21,197] | | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

| | | | 2024 | | | | | | 2023 | | |

| | | | 42,934 | | | | | | 41,317 | | |

| | | | 23,779 | | | | | | 23,051 | | |

| | | | 104,616 | | | | | | 95,031 | | |

| | | | $ | 117,106 | | | | | $ | 106,675 | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

| Balance December 31, 2024 | | | $ | 1,788 | | | | | $ | 44,704 | | | | | $ | 63,069 | | | | | $ | (4,945) | | | | | $ | (58,303) | | | | | $ | 59 | | | | | $ | 46,372 | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

| Charges for certain research and development asset acquisitions | | | 3,456 | | | | | | 11,409 | | | | | | — | | |

| Acquisition of Eyebiotech Limited, net of cash acquired | | | (1,344) | | | | | | — | | | | | | — | | |

| Acquisition of Elanco Animal Health Incorporated aqua business | | | (1,303) | | | | | | — | | | | | | — | | |

| Acquisition of MK-1045 from Curon Pharmaceutical | | | (700) | | | | | | — | | | | | | — | | |

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

For those subsidiaries that operate in highly inflationary economies and for those subsidiaries where the U.S. dollar has been determined to be the functional currency, non-monetary foreign currency

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

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[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

that is considered a service agreement, which are included in *Other Assets*.

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

(within *Sales*).

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

based milestone payments and other reserves, pension and other postretirement benefit plan assumptions, share-based compensation assumptions, restructuring costs, impairments of long-lived assets (including intangible assets and goodwill) and investments, and taxes on income.

See Note 18 for further details.

The guidance will result in incremental disclosures within the footnotes to the Company’s financial statements.

In November 2024, the FASB issued guidance intended to improve financial reporting by requiring entities to disclose additional information about specific expense categories at interim and annual reporting periods.

The guidance, which can be applied on a prospective or retrospective basis, will result in incremental disclosures within the footnotes to the Company’s financial statements.

In January 2025, Merck and WuXi Vaccines, a wholly owned subsidiary of WuXi Biologics, entered into a definitive agreement pursuant to which Merck will acquire WuXi Vaccines’ facility in Dundalk, Ireland for a payment of approximately $440 million at closing.

The transaction is expected to close in the first quarter of 2025, subject to the satisfaction of customary closing conditions.

2024 Transactions

In December 2024, Merck closed an exclusive global license to develop, manufacture and commercialize MK-2010 (LM-299), a novel investigational PD-1/vascular endothelial growth factor (VEGF) bispecific antibody from LaNova Medicines Ltd (LaNova).

LaNova is also eligible to receive $300 million upon technology transfer, which is anticipated to be completed in 2025, as well as future contingent developmental milestone payments of up to $140 million, regulatory milestone payments of up to $860 million and sales-based milestone payments of up to $1.4 billion.

Also in December 2024, Merck closed an exclusive global license to develop, manufacture and commercialize MK-4082 (HS-10535), an investigational preclinical oral small molecule GLP-1 receptor agonist from Hansoh Pharma (Hansoh).

Merck recorded a charge of $112 million to *Research and development* expenses in 2024 for the upfront payment, which was made in February 2025.

Hansoh is also eligible to receive future contingent

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

development-related milestone payments of up to $115 million, regulatory milestone payments of up to $315 million and sales-based milestone payments of up to $1.47 billion, as well as tiered royalties ranging from a high-single-digit rate to a low-double-digit rate on future net sales of MK-4082 (HS-10535), if approved.

Under the agreement, Hansoh may co-promote or solely commercialize MK-4082 (HS-10535) in Chinese mainland, Hong Kong and Macau, subject to certain conditions.

In September 2024, Merck acquired MK-1045 (formally CN201), a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases, from Curon Biopharmaceutical (Curon) for an upfront payment of $700 million.

In addition, Curon is eligible to receive future contingent developmental milestone payments of up to $300 million and regulatory milestone payments of up to $300 million.

| Income from Continuing Operations | | | $ | 0.14 | | | | | $ | 5.73 | | | | | $ | 4.88 | |

| Income from Discontinued Operations | | | — | | | | | | — | | | | | | 0.28 | | |

| Net Income | | | $ | 0.14 | | | | | $ | 5.73 | | | | | $ | 5.16 | |

| Income from Continuing Operations | | | $ | 0.14 | | | | | $ | 5.71 | | | | | $ | 4.86 | |

| Net Income | | | $ | 0.14 | | | | | $ | 5.71 | | | | | $ | 5.14 | |

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

| | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | 41,317 | | | | | | 39,407 | | |

| | | | 95,031 | | | | | | 102,480 | | |

| Balance January 1, 2021 | | | $ | 1,788 | | | | | $ | 39,588 | | | | | $ | 47,362 | | | | | $ | (6,634) | | | | | $ | (56,787) | | | | | $ | 87 | | | | | $ | 25,404 | |

| Distributions attributable to noncontrolling interests | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (25) | | | | | | (25) | | |

| Charge for the acquisition of Prometheus Biosciences, Inc. | | | 10,217 | | | | | | — | | | | | | — | | |

| Charge for the acquisition of Imago BioSciences, Inc. | | | 1,192 | | | | | | — | | | | | | — | | |

| Charge for the acquisition of Pandion Therapeutics, Inc. | | | — | | | | | | — | | | | | | 1,556 | | |

| Acquisition of Pandion Therapeutics, Inc., net of cash acquired | | | — | | | | | | — | | | | | | (1,554) | | |

| Other acquisitions, net of cash acquired | | | — | | | | | | (121) | | | | | | (179) | | |

| Net change in short-term borrowings | | | — | | | | | | — | | | | | | (3,986) | | |

| Distribution from Organon & Co. | | | — | | | | | | — | | | | | | 9,000 | | |

| Cash Flows from Discontinued Operations | | | | | | | | | | | | | | | | | |

| Net cash provided by operating activities | | | — | | | | | | — | | | | | | 987 | | |

| Net cash used in investing activities | | | — | | | | | | — | | | | | | (134) | | |

| Net cash used in financing activities | | | — | | | | | | — | | | | | | (504) | | |

| Net Cash Flows Provided by Discontinued Operations | | | — | | | | | | — | | | | | | 349 | | |

*Spin-Off of Organon & Co.*

On June 2, 2021, Merck completed the spin-off of products from its women’s health, biosimilars and established brands businesses into a new, independent, publicly traded company named Organon & Co. (Organon) through a distribution of Organon’s publicly traded stock to Company shareholders.

The established brands included in the transaction consisted of dermatology, non-opioid pain management, respiratory, select cardiovascular products, as well as the rest of Merck’s diversified brands franchise.

The historical results of the businesses that were contributed to Organon in the spin-off have been reflected as discontinued operations in the Company’s consolidated financial statements through the date of the spin-off (see Note 5).

accounting guidance.

The adoption of this guidance did not have an impact on the Company’s consolidated financial statements for prior acquisitions; however, the impact in future periods will be dependent upon the contract assets and contract liabilities acquired in future business combinations.

In June 2022, the FASB issued guidance related to the fair value measurement of an equity security subject to contractual restrictions that prohibit the sale of the equity security.

The new guidance also introduces new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value.

*Recently Issued Accounting Standards Not Yet Adopted —* In August 2023, the FASB issued amended guidance that requires a newly formed joint venture to recognize and initially measure its assets and liabilities at fair value upon formation.

The amended guidance 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.

Early adoption is permitted.

The Company is currently evaluating the impact of adoption on the disclosures within its consolidated financial statements.

The Elanco aqua business to be acquired consists of an

The acquisition is expected to be completed by mid-2024, subject to approvals from regulatory authorities and other customary closing conditions.

For the fourth quarter of [removed: 2023,] [added: 2024,] there have been no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

Based on this evaluation, management concluded that internal control over financial reporting was effective as of December 31, [removed: 2023.][added: 2024.]

The effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears herein.

| [removed: ] [added: ] | | | | | |

| ] [added: Sig..jpg](https://www.sec.gov/Archives/edgar/data/310158/000162828025007732/mrk-20241231_g9.jpg)] | | | | | |

Based on this evaluation, management concluded that internal control over financial reporting was effective as of December 31, 2024.

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During the three months ended December 31, [removed: 2023,] [added: 2024,] none of the Company’s directors or executive officers adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements.

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Election of Directors of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

Information on executive officers is set forth in Part I of this document on page [removed: [41](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_67).][added: [43](#i783cf867b028427ba2fa2dcfd656c4d4_70).]

The required information on compliance with Section 16(a) of the Securities Exchange Act of 1934, if applicable, is incorporated by reference from the discussion under the heading “Stock Ownership Information” of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

The Company has a Code of Conduct — *Our Values and Standards* applicable to all employees, including the principal executive officer, principal financial officer, [added: and] principal accounting [removed: officer and Controller.][added: officer.]

The required information on the identification of the audit committee and the audit committee financial expert is incorporated by reference from the discussion under the heading “Board Meetings and Committees” of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

The required information about the Company’s insider trading policy is incorporated by reference from the discussion under the heading “Insider Trading Policy” of the Company's Proxy Statement for the Annual Meeting of Shareholders to be held on May 27, 2025.

The information required on executive compensation is incorporated by reference from the discussion under the headings “Compensation Discussion and Analysis,” “Summary Compensation Table,” “All Other Compensation” table, “CEO Pay Ratio,” “Pay [removed: vs.] [added: versus] Performance” table, “Grants of Plan-Based Awards” table, “Outstanding Equity Awards” table, “Option Exercises and Stock Vested” table, “Pension Benefits” table, “Nonqualified Deferred Compensation” table, and “Potential Payments Upon Termination or a Change in Control”, [removed: including the discussion under the subheadings “Separation” and “Change in Control,”] as well as all footnote information to the various tables, of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

The required information on director compensation is incorporated by reference from the discussion under the heading “Director Compensation” and related [removed: “2023] [added: “2024] Schedule of Director Fees” table and [removed: “2023] [added: “2024] Director Compensation” table of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

The required information under the headings “Compensation and Management Development Committee Interlocks and Insider Participation” and “Compensation and Management Development Committee Report” is incorporated by reference from the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

Information with respect to security ownership of certain beneficial owners and management is incorporated by reference from the discussion under the heading “Stock Ownership Information” of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

The following table summarizes information about the options, warrants and rights and other equity compensation under the Company’s equity compensation plans as of the close of business on December 31, [removed: 2023.][added: 2024.]

*(2)Excludes approximately [removed: 12,541,646] [added: 12,232,051] shares of restricted stock units and [removed: 1,966,333] [added: 3,531,246] performance share units (assuming maximum payouts) under the Merck Sharp & Dohme 2010 and 2019 Incentive Stock Plans.

Also excludes [removed: 157,619] [added: 153,540] shares of phantom stock deferred under the MSD Employee Deferral Program and [removed: 503,549] [added: 518,423] shares of phantom stock deferred under the Merck & Co., Inc. Plan for Deferred Payment of Directors’ Compensation.*

| Equity compensation plans approved by security holders*(1)* | | | | | | 12,500,010*(2)* | | | | | | $ | 86.04 | | | | | 74,988,831 | | |

| Total | | | | | | 12,500,010 | | | | | | $ | 86.04 | | | | | 74,988,831 | | |

| Equity compensation plans approved by security holders*(1)* | | | | | | 13,526,932*(2)* | | | | | | $ | 77.54 | | | | | 81,123,362 | | |

| Total | | | | | | 13,526,932 | | | | | | $ | 77.54 | | | | | 81,123,362 | | |

The required information on transactions with related persons is incorporated by reference from the discussion under the heading “Related Person Transactions” of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

The required information on director independence is incorporated by reference from the discussion under the heading “Independence of Directors” of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

The information required for this item is incorporated by reference from the discussion under Proposal [removed: 4.][added: 3.]

Ratification of Appointment of Independent Registered Public Accounting Firm for [removed: 2024] [added: 2025] beginning with the caption “Pre-Approval Policy for Services of Independent Registered Public Accounting Firm” through “Fees for Services Provided by the Independent Registered Public Accounting Firm” of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held [added: on] May [removed: 18, 2024.][added: 27, 2025.]

[Table of Content](#i783cf867b028427ba2fa2dcfd656c4d4_7)[s](#i783cf867b028427ba2fa2dcfd656c4d4_7)

[Table of C](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[o](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[ntent](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)[s](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_7)

Consolidated statement of income for the years ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021][added: 2022]

Consolidated statement of comprehensive [removed: (loss)] income [added: (loss)] for the years ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021][added: 2022]

Consolidated balance sheet as of December 31, [removed: 2023] [added: 2024] and [removed: 2022][added: 2023]

Consolidated statement of equity for the years ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021][added: 2022]

Consolidated statement of cash flows for the years ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021][added: 2022]

| 3.1 | | | | | | — | | | | | | [Restated Certificate of Incorporation of Merck & Co., Inc. (November 3, 2009) — Incorporated by reference to Merck & Co., Inc.’s Current Report on Form 8-K filed November 4, 2009 (No. [removed: 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000119312509223917/dex31.htm)] [added: 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000119312509223917/dex31.htm)] | | |

| 4.2 | | | | | | — | | | | | | [First Supplemental Indenture to the 1991 Indenture, dated as of October 1, 1997 — Incorporated by reference to Exhibit 4(b) to MSD’s Registration Statement on Form S-3 filed September 25, 1997 (No. [removed: 333-36383)](http://www.sec.gov/Archives/edgar/data/64978/0000950123-97-008101.txt)] [added: 333-36383)](https://www.sec.gov/Archives/edgar/data/64978/0000950123-97-008101.txt)] | | |

| 4.3 | | | | | | — | | | | | | [Second Supplemental Indenture to the 1991 Indenture, dated November 3, 2009 — Incorporated by reference to Exhibit 4.3 to Merck & Co., Inc.’s Current Report on Form 8-K filed November 4, 2009 [removed: (No.1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000119312509223917/dex43.htm)] [added: (No.1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000119312509223917/dex43.htm)] | | |

| 4.4 | | | | | | — | | | | | | [Third Supplemental Indenture to the 1991 Indenture, dated May 1, 2012 — Incorporated by reference to Exhibit 4.1 to Merck & Co., Inc.’s Form 10-Q Quarterly Report for the period ended March 31, 2012 (No. [removed: 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000119312512216683/d318209dex41.htm)] [added: 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000119312512216683/d318209dex41.htm)] | | |

| 4.5 | | | | | | — | | | | | | [Indenture, dated November 26, 2003, between Merck & Co., Inc. (f/k/a Schering-Plough Corporation) and The Bank of New York as Trustee (the 2003 Indenture) — Incorporated by reference to Exhibit 4.1 to Schering-Plough’s Current Report on Form 8‑K filed November 28, 2003 (No. [removed: 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000095012303013260/y92128exv4w1.txt)] [added: 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000095012303013260/y92128exv4w1.txt)] | | |

| 4.6 | | | | | | — | | | | | | [Second Supplemental Indenture to the 2003 Indenture (including Form of Note), dated November 26, 2003 — Incorporated by reference to Exhibit 4.3 to Schering-Plough’s Current Report on Form 8‑K filed November 28, 2003 (No. [removed: 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000095012303013260/y92128exv4w3.txt)] [added: 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000095012303013260/y92128exv4w3.txt)] | | |

| 4.7 | | | | | | — | | | | | | [Third Supplemental Indenture to the 2003 Indenture (including Form of Note), dated September 17, 2007 — Incorporated by reference to Exhibit 4.1 to Schering-Plough’s Current Report on Form 8‑K filed September 17, 2007 (No. [removed: 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000095012307012711/y39738exv4w1.htm)] [added: 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000095012307012711/y39738exv4w1.htm)] | | |

| 4.8 | | | | | | — | | | | | | [Fifth Supplemental Indenture to the 2003 Indenture, dated November 3, 2009 — Incorporated by reference to Exhibit 4.4 to Merck & Co., Inc.’s Current Report on Form 8-K filed November 4, 2009 (No. [removed: 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000119312509223917/dex44.htm)] [added: 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000119312509223917/dex44.htm)] | | |

| 4.9 | | | | | | — | | | | | | [Indenture, dated as of January 6, 2010, between Merck & Co., Inc. and U.S. Bank Trust National Association, as Trustee — Incorporated by reference to Exhibit 4.1 to Merck & Co., Inc.’s Current Report on Form 8-K filed December 10, 2010 (No. [removed: 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000119312510278450/dex41.htm)] [added: 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000119312510278450/dex41.htm)] | | |