Merck & Co. (MRK) 10-K risk factor changes: FY2023 vs FY2022

- The Company’s research and development efforts may not succeed in developing commercially successful products and the Company may not be able to acquire commercially successful products in other ways; [removed: in consequence,] [added: consequently,] the Company may not be able to replace sales of successful products that lose patent protection.

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

[removed: - The Company faces] [added: Also, the Company’s products face] intense competition from competitors’ products.

[removed: - The] [added: Events like these, such as the] ongoing war between Russia and [removed: Ukraine] [added: Ukraine,] and [removed: related global disruptions] [added: rising conflict in the Middle East,] could [added: result in material adverse effects on macroeconomic conditions, currency exchange rates and financial markets, and may] adversely affect the Company’s business, results of operations and financial condition.

- Negative events in the animal health industry could have a material adverse effect on future results of operations and financial [removed: condition.][added: condition of the Company or its Animal Health business.]

The Company [removed: could] [added: continues to] be a target of [removed: future] cyber-attacks that could lead to a disruption of its worldwide operations, including manufacturing, research and sales operations.

A chart listing the [added: key] patent protection for certain of the Company’s marketed products, and U.S. patent protection for candidates in Phase 3 clinical development is set forth above in Item 1.

[removed: As these products] [added: In addition, the Company expects to] lose [removed: exclusivity,] [added: market exclusivity in] the [added: U.S. for *Keytruda* in 2028 and the] Company anticipates that sales of [removed: *Januvia* and *Janumet*] [added: *Keytruda* in the U.S.] will decline [removed: substantially.][added: substantially thereafter.]

Key products generate a significant amount of the Company’s profits and cash flows, and any events that adversely affect the markets for its leading products could have a material adverse effect on the Company’s results of operations and financial [removed: condition.][added: condition.]

The Company’s research and development efforts may not succeed in developing commercially successful products and the Company may not be able to acquire commercially successful products in other ways; [removed: in consequence,] [added: consequently,] the Company may not be able to replace sales of successful products that lose patent protection.

[added: The Company must maintain a continuous flow of successful new products and successful new indications for existing products] sufficient both to cover its substantial research and development costs and to replace sales that are lost as profitable products lose market exclusivity or are displaced by competing products or therapies.

In the U.S., these include (i) [removed: practices of managed care groups and institutional and governmental purchasers, (ii)] U.S. federal laws and regulations related to Medicare and Medicaid, including the Medicare Prescription Drug Improvement and Modernization Act of 2003, the ACA, [added: and] the [removed: Inflation Reduction Act,] [added: IRA, (ii) practices of managed care groups] and [added: institutional and governmental purchasers, and] (iii) state activities aimed at increasing price transparency, including new laws as noted above in Item 1.

In [removed: 2022,] [added: 2023,] the Company’s gross U.S. sales were reduced by [removed: 39.7%] [added: 37%] as a result of rebates, discounts and returns.

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

Furthermore, the [added: Japanese] government can order re-pricing for specific products if it determines that use of such product will exceed certain thresholds defined under applicable re-pricing rules.

[removed: As discussed above in] “Competition and the Health Care Environment,” global efforts toward health care cost containment continue to exert pressure on product pricing and market access worldwide.

In addition, the Company’s sales performance in [removed: 2022] [added: 2023] was negatively affected by other cost-reduction measures taken by governments and other third parties to lower health care costs.

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

In addition, there may be changes to the Company’s business [removed: and political position] if there is instability, disruption or destruction in a significant geographic region, regardless of cause, including war, terrorism, riot, civil insurrection or social unrest; and natural or man-made disasters, including famine, flood, fire, earthquake, storm or disease.

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

The Company is exposed to physical risks (such as extreme weather [removed: conditions] [added: conditions, inland flooding] or rising sea levels), risks in transitioning to a low-carbon economy (such as additional legal or regulatory requirements, changes in technology, market risk and reputational risk) and social and human effects (such as population dislocations and harm to health and well-being) associated with climate change.

Extreme [removed: weather] [added: weather, inland flooding] and sea-level rise pose physical risks to the Company’s facilities as well as those of its suppliers.

[added: 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 greenhouse gas emissions, investment in new technologies, increased [removed: carbon] [added: greenhouse gas emission] disclosure [added: (including costs resulting from mandatory or voluntary reporting, diligence or disclosure)] and transparency, [added: 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.

The Company’s supply chain would likely be subject to these same transitional risks and would likely pass along any increased costs to the Company, [removed: all of] which may affect the Company’s ability to procure raw materials or other supplies required for the operation of the Company’s business at the quantities and levels [removed: we require.][added: required.]

This focus on ESG concerns may lead to new requirements that could result in increased costs associated with developing, manufacturing and distributing the Company’s [removed: products.][added: 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 [added: validated net zero greenhouse gas emission targets and] more environmentally friendly products, packaging or supplier practices, or by failure to meet such customer expectations or demand.

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

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

[removed: Difficulties] [added: However, difficulties] in reducing those levels, or achieving timely regulatory approvals for required changes, could result in product shortages.

In order for the Company to [added: operate] successfully [removed: implement its] [added: in] emerging [removed: markets strategy,] [added: markets,] it must attract and retain qualified personnel.

[added: In addition to its commercial operations, the Company has significant research and manufacturing operations in China, including working with Chinese entities such as Wuxi Apptech Co., Ltd.] If geopolitical tensions were to increase and disrupt the Company’s operations in China, such disruption could result in a material adverse effect on the Company’s product development, sales, business, cash flow, results of operations, financial condition and prospects.

[removed: As noted above in] “Competition and the Health Care Environment,” pricing pressure in China has increased as the Chinese government has been taking steps to reduce costs, including implementing health care reform that has led to the acceleration of generic substitution, where available.

However, at the same time, [removed: macro economic] [added: macro-economic] growth of selected emerging markets is expected to [removed: outpace Europe and even the U.S., leading] [added: lead] to significant increased health care spending in those countries and access to innovative medicines for patients.

Since the Company cannot, with certainty, foresee and mitigate against such adverse [removed: fluctuations,] [added: changes,] fluctuations in currency exchange rates, interest rates and inflation could negatively affect the Company’s business, cash flow, results of operations, financial condition and prospects.

The Company depends on third parties, including suppliers, [added: distributors,] alliances with other pharmaceutical and biotechnology companies, and third-party service providers, for key aspects of its business including development, manufacture and commercialization of its products and support for its information technology (IT) systems.

Negative events in the animal health industry could have a material adverse effect on future results of operations and financial [removed: condition.][added: condition of the Company or its Animal Health business.]

For example, the outbreak of disease carried by animals, such as African Swine [removed: Fever,] [added: Fever or Avian Influenza,] could lead to their widespread death and precautionary destruction as well as the reduced consumption and demand for animals, which could adversely affect the Company’s results of operations.

Other risks specific to animal health include epidemics and [removed: pandemics,] [added: pandemics affecting livestock,] government procurement and pricing practices, weather and global agribusiness economic events.

In addition, in [removed: 2022,] [added: 2023,] sales of *Bravecto* were [removed: $1.0] [added: $1.1] billion, which represented [removed: approximately] 19% of the Company’s Animal Health segment sales.

- Manufacturing biologics and vaccines, especially in large quantities, is [removed: often] complex and may require the use of innovative technologies to handle living micro-organisms.

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

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

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

In 2023, the Company lost market exclusivity for *Bridion* in the EU and the Company has experienced a substantial decline in *Bridion* sales in those markets.

*Bridion* 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 in those markets will decline substantially thereafter.

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

In particular, in the aggregate, in 2023, sales of *Keytruda* and *Gardasil/Gardasil 9* represented 56% of the Company’s total sales.

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

As noted in Item 1.

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

Furthermore, the Company anticipates that HHS will include *Keytruda* in a subsequent selection of products to undergo IRA price setting, with such price likely to be effective in early 2028.

Consequently, in those markets, the Company is subject to government

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

As discussed above in Item 1.

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

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

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.

These evolving regulatory requirements are likely to result in increased costs and complexities of compliance in order to collect, measure and report on the relevant ESG-related information.

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.

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

As noted above in Item 1.

For example, Argentina is currently experiencing hyperinflation, which is affecting the Company’s operations in that market.

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

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

As discussed above in Item 1.

As noted in Item 1.

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

Furthermore, the Company anticipates that HHS will include *Keytruda* in a subsequent selection of products to undergo IRA price setting, with such price likely to be effective in early 2028.

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

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

countries.

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

acquisition; the use of which can create new risks.

In addition, the Company’s Animal Health business sells technology products that, when deployed, could potentially be compromised by a third party and cause disruption both internally and externally.

The Company’s growing use of artificial intelligence (AI) systems to automate processes, analyze data, and support decision-making poses inherent risks.

Flaws, biases, or malfunctions in these systems could lead to operational disruptions, data loss, or erroneous decision-making, impacting the Company’s business operations, financial condition, and reputation.

Ethical and legal challenges may arise, including biases or discrimination in AI outcomes, non-compliance with data protection regulations, and lack of transparency.

Furthermore, the deployment of AI systems could expose the Company to increased cybersecurity threats, such as data breaches and unauthorized access leading to financial losses, legal liabilities, and reputational damage.

The Company also faces competitive risks if it fails to adopt AI or other machine learning technologies in a timely fashion.

A drug candidate can fail at any stage of

The Company expects that sales of *Lagevrio*, which were $5.7 billion in 2022, will decline significantly to approximately $1.0 billion in 2023.

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

- COVID-19-related disruptions have had an adverse impact on the Company’s business, operations and financial performance.

The Company is unable to predict the full extent to which the COVID-19 pandemic or any future pandemic, epidemic or similar public health threat will adversely impact its business, operations, financial performance, results of operations, and financial condition.

While the key U.S.

patent for *Januvia* and *Janumet* claiming the sitagliptin compound expired in January 2023, as a result of favorable court rulings and settlement agreements related to a later expiring patent directed to the specific sitagliptin salt form of the products, the Company expects that these products will not lose market exclusivity in the U.S. until May 2026.

However, certain of the rulings are currently being appealed, and an unfavorable court decision would likely cause the products to lose exclusivity in the U.S. toward the end of 2023.

The Company lost market exclusivity for *Januvia* in all of the EU and for *Janumet* in some European countries in September 2022.

Merck expects that exclusivity for *Janumet* will be lost in other European countries in April 2023.

While the Company lost market exclusivity for *Januvia* in China in 2022 with the approval of a generic equivalent product, the impact on sales in 2023 is expected to be modest.

It is anticipated that a generic equivalent of *Janumet* will be approved in China in the first quarter of 2023, but the impact to sales in 2023 is also expected to be modest.

The Company expects that sales of Lagevrio, which were $5.7 billion in 2022, will decline significantly to approximately $1.0 billion in 2023.

In particular, in 2022, sales of *Lagevrio*, which were $5.7 billion, represented a substantial portion of the Company’s revenue and profit growth.

The Company expects that sales of *Lagevrio* will decline significantly to approximately $1.0 billion in 2023.

The Company must maintain a continuous flow of successful new products and successful new indications for existing products

As a result of global macroeconomic conditions, the Company is experiencing some minor disruption and volatility in its global supply chain network.

These disruptions could increase in the future and cause delays in shipments of raw materials and packaging, as well as related cost inflation.

Any such disruptions, delays or costs may result in the Company’s inability to meet demand for the Company’s products.

The Company faces intense competition from competitors’ products.

The Company’s products face intense competition from competitors’ products.

COVID-19-related disruptions have had an adverse impact on the Company’s business, operations and financial performance.

The Company is unable to predict the full extent to which the COVID-19 pandemic or any future pandemic, epidemic or similar public health threat will adversely impact its business, operations, financial performance, results of operations, and financial condition.

The Company’s business and financial results have been negatively impacted by COVID-19-related disruptions since the start of the pandemic.

Merck believes that global health systems and patients have largely adapted to the impacts of COVID-19, however, a substantial portion of Merck’s Pharmaceutical segment revenue is comprised of physician-administered products which could be adversely affected by the pandemic if it continues.

The continued duration and severity of the COVID-19 pandemic is uncertain and difficult to predict.

The degree to which COVID-19-related disruptions impact the Company’s results in 2023 will depend on future developments, beyond the Company’s knowledge or control, including governmental and third-party actions taken to contain or prevent the spread and treatment of the virus and mitigate its public health and economic effects.

In addition, any future pandemic, epidemic or similar public health threat could present similar risks to the Company’s business, cash flow, results of operations, financial condition and prospects.

Events like these could result in material adverse effects on macroeconomic conditions, currency exchange rates and financial markets.

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,

In addition to its commercial operations, the Company has significant research and manufacturing operations in China.

In 2021, drugs were added to the NRDL with an average of more than 60% price reductions.

The ongoing war between Russia and Ukraine and related global disruptions could adversely affect the Company’s business, results of operations and financial condition.

The ongoing war between Russia and Ukraine, and the financial and economic sanctions imposed by the U.S., the EU and other countries in response, are having pervasive direct and indirect effects on the global economy, and may adversely affect the Company’s business, results of operations and financial condition.

The Company is working cross-functionally across the globe to monitor and mitigate interruptions to business continuity resulting from the war, including its impact on Merck’s supply chain, operations and clinical trials.

For humanitarian reasons, the Company is continuing to supply essential medicines and vaccines in Russia while working to maintain compliance with international sanctions.

Merck is donating profits resulting from its operations in Russia to humanitarian causes.

The Company does not have research or manufacturing facilities in Russia, currently does not plan to make further investments in Russia, and has suspended screening and enrollment in ongoing clinical trials as well as planning for new studies in Russia, although the Company continues to treat patients already enrolled in existing clinical trials and collect data from these studies.

The financial impacts of the war between Russia and Ukraine were immaterial to the Company’s consolidated financial statements in 2022.

However, the degree to which the war and related disruptions will impact the Company’s results in the future is difficult to predict and will depend on developments outside of the Company’s control, including, but not limited to, the duration and severity of the war, ongoing and additional financial and economic sanctions imposed by governments in response, restrictions on travel, regional instability, geopolitical

shifts, and adverse effects on fuel and energy costs, supply chains, macroeconomic conditions, currency exchange rates and financial markets.

The following section of this Form 10-K generally discusses [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] results and year-to-year comparisons between [removed: 2022] [added: 2023] and [removed: 2021.][added: 2022.]

[removed: Discussion of 2020 results and year-to-year comparisons between 2021 and 2020 that are not included in this Form 10-K can be found in] “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in [removed: Part II, Item 7 of] the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2021] [added: 2022] filed on February [removed: 25, 2022.][added: 24, 2023.]

The Company sells these human health vaccines primarily to physicians, wholesalers, [removed: physician] distributors and government entities.

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 [removed: 3] [added: 5] to the consolidated financial statements).

| *($ in millions except per share amounts)* | | | [removed: 2022] [added: 2023] | | | | | | % Change | | | | | | % Change Excluding Foreign Exchange | | | | | | [removed: 2021] [added: 2022] | | | | | | % Change | | | | | | % Change Excluding Foreign Exchange | | | | | | [removed: 2020] [added: 2021] | | |

| Sales | | | $ | [removed: 59,283] [added: 60,115] | | | | | [removed: 22] [added: 1] | | % | | | | [removed: 26] [added: 4] | | % | | | | $ | [removed: 48,704] [added: 59,283] | | | | | [removed: 17] [added: 22] | | % | | | | [removed: 16] [added: 26] | | % | | | | $ | [removed: 41,518] [added: 48,704] | |

| GAAP | | | $ | [removed: 14,519] [added: 365] | | | | | [removed: 18] [added: (97)] | | % | | | | [removed: 21] [added: (95)] | | % | | | | $ | [removed: 12,345] [added: 14,519] | | | | | [removed: *] [added: 18] | | [added: %] | | | | [removed: *] [added: 21] | | [added: %] | | | | $ | [removed: 4,519] [added: 12,345] | |

| Non-GAAP *(1)* | | | $ | [removed: 19,005] [added: 3,837] | | | | | [removed: 40] [added: (80)] | | % | | | | [removed: 43] [added: (75)] | | % | | | | $ | [removed: 13,623] [added: 19,005] | | | | | [removed: 81] [added: 40] | | % | | | | [removed: 98] [added: 43] | | % | | | | $ | [removed: 7,545] [added: 13,623] | |

| GAAP | | | $ | [removed: 5.71] [added: 0.14] | | | | | [removed: 17] [added: (98)] | | % | | | | [removed: 21] [added: (95)] | | % | | | | $ | [removed: 4.86] [added: 5.71] | | | | | [removed: *] [added: 17] | | [added: %] | | | | [removed: *] [added: 21] | | [added: %] | | | | $ | [removed: 1.78] [added: 4.86] | |

| Non-GAAP *(1)* | | | $ | [removed: 7.48] [added: 1.51] | | | | | [removed: 39] [added: (80)] | | % | | | | [removed: 43] [added: (75)] | | % | | | | $ | [removed: 5.37] [added: 7.48] | | | | | [removed: 81] [added: 39] | | % | | | | [removed: 98] [added: 43] | | % | | | | $ | [removed: 2.97] [added: 5.37] | |

*(1)* *Non-GAAP net income and non-GAAP earnings per share (EPS) exclude [removed: acquisition] [added: acquisition-] and divestiture-related costs, restructuring costs, [removed: gains] [added: income] and losses from investments in equity securities, and certain other items from Merck’s results prepared in accordance with generally accepted accounting principles in the U.S. (GAAP).

[removed: ][added: ]

Worldwide sales were [removed: $59.3] [added: $60.1] billion in [removed: 2022,] [added: 2023,] an increase of [removed: 22%] [added: 1%] compared with [removed: 2021,] [added: 2022,] or [removed: 26%] [added: 4%] excluding the unfavorable effect of foreign exchange.

The sales increase was primarily due to growth in [added: oncology, vaccines, hospital acute care and animal health, partially offset by declines in] virology (driven by [removed: the benefit] [added: lower sales] of [removed: *Lagevrio* sales), oncology, vaccines] [added: COVID-19 medication *Lagevrio*)] and [removed: hospital acute care.][added: diabetes.]

Highlights of [removed: 2022] [added: 2023] activity include the following:

- [removed: Entered into] [added: 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 [removed: seven] [added: 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 [removed: Macau); the transaction closed in February 2023.][added: Macau).]

- [removed: Entered into agreement to acquire] [added: Acquired] Imago BioSciences, Inc. (Imago), a [removed: clinical stage] [added: clinical-stage] biopharmaceutical company developing new medicines for the treatment of myeloproliferative neoplasms and other bone marrow [removed: diseases; the acquisition closed in January 2023.][added: diseases.]

During [removed: 2022,] [added: 2023,] the Company received [added: more than 25 regulatory approvals in major markets, including] numerous regulatory approvals within oncology.

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

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

Lynparza, which is being developed in collaboration with AstraZeneca PLC (AstraZeneca), received [removed: approval] [added: approvals] in the [removed: U.S., the European Union (EU)] [added: U.S. in combination with abiraterone] and [added: prednisone or prednisolone and in] Japan [removed: for the adjuvant treatment of certain adult patients] [added: in combination] with [removed: high-risk early breast cancer] [added: abiraterone] and [removed: in the EU] [added: prednisolone - both] for the treatment of certain [added: adult] patients with [removed: mCRPC.][added: *BRCA*\-mutated (*BRCA*m) metastatic castration-resistant prostate cancer (mCRPC).]

[added: - Additionally,] *Keytruda* is under review in the U.S. and/or [removed: internationally] [added: in international markets] for supplemental indications for the treatment of certain patients with [removed: hepatocellular, Merkel cell,] [added: biliary tract, cervical, endometrial, gastric,] non-small-cell lung and urothelial [removed: cancers, as well as primary mediastinal B-cell lymphoma (PMBCL).][added: cancers.]

[removed: Lynparza] [added: - *Welireg*] is under review [removed: for supplemental indications] in the [removed: U.S. and Japan] [added: EU] for the treatment of certain patients with [removed: mCRPC.][added: advanced RCC and for the treatment of von Hippel-Lindau disease.]

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

- MK-3475A, the subcutaneous coformulation of pembrolizumab with [removed: hyaluronidase,] [added: hyaluronidase] for [added: certain types of] NSCLC;

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

- V116, an investigational 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in [removed: adults;][added: adults, is also under priority review by the FDA.]

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

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

- MK-4482, *Lagevrio*, which is reflected in Phase 3 development in the U.S. as it remains investigational following Emergency Use Authorization [added: (EUA)] in 2021.

Merck’s capital allocation [removed: priorities are] [added: strategy continues] to [removed: make] [added: prioritize] investments in its business to drive near- and long-term growth, including investing in opportunities to address important unmet medical needs and supporting the Company’s commercial opportunities.

In addition, Merck remains committed to its dividend and will continue to pursue the most compelling external science [added: and technologies] through value-enhancing business development transactions.

Research and development expenses in [removed: 2022] [added: 2023] reflect higher [removed: clinical] [added: charges for business] development [added: transactions and increased development] spending particularly in the therapeutic areas of oncology, cardiovascular, infectious diseases and vaccines.

[removed: ][added: ]

In November [removed: 2022,] [added: 2023,] Merck’s Board of Directors approved an increase to the Company’s quarterly dividend, raising it to [removed: $0.73] [added: $0.77] per share from [removed: $0.69] [added: $0.73] per share on the Company’s outstanding common stock.

[removed: ][added: ]

*GAAP and Non-GAAP EPS were negatively affected in [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020] [added: 2021] by [added: $6.21,] $0.22, [removed: $0.65,] and [removed: $1.56,] [added: $0.65,] respectively, of charges for certain upfront and pre-approval milestone payments related to collaborations and licensing agreements, as well as charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions.*

In addition, the Company’s sales performance in [removed: 2022] [added: 2023] was negatively affected by other cost-reduction measures taken by governments and other third parties to lower health care costs.

In 2022, the U.S. Congress passed the Inflation Reduction [removed: Act,] [added: Act (IRA),] which makes significant changes to how drugs are covered and paid for under the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug benefits, and government price-setting for certain Medicare Part D drugs (starting in 2026) and Medicare Part B drugs (starting in 2028).

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

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

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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leading edge science, and advanced its broad pipeline which includes growing diversity across new therapeutic areas and modalities.

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.

*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).

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- 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.

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

The Company is diversifying its oncology portfolio and executing on its strategy which is broadly based on three strategic pillars: immuno-oncology, precision molecular targeting and tissue targeting.

Merck’s Phase 3 oncology programs within these pillars are as follows:

*Immuno-oncology*

- V940, an investigational individualized neoantigen therapy, in combination with *Keytruda*, for certain types of melanoma and NSCLC, being developed in collaboration with Moderna.

*Precision molecular targeting*

- MK-1026, nemtabrutinib, an oral, reversible, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, for hematological malignancies;

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

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

*Tissue targeting*

*•*MK-2870, an investigational trophoblast cell-surface antigen 2 (TROP2)-directed ADC being developed in collaboration with Kelun-Biotech for endometrial carcinoma and certain types of NSCLC.

- MK-0616, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for hypercholesterolemia;

- 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 ulcerative colitis;

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During 2023, the Company returned $8.8 billion to shareholders through dividends of $7.4 billion and share repurchases of $1.3 billion.

In August 2023, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced that *Januvia* will be included in the first year of the IRA’s “Drug Price Negotiation Program” (Program).

Pursuant to the IRA’s Program, discussions with the government occurred in 2023 and will continue in 2024, with government price-setting becoming effective on January 1, 2026.

The Company has sued the U.S. government regarding the IRA’s Program (see Note 11 to the consolidated financial statements).

Furthermore, the Biden

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Worldwide sales grew 1% to $60.1 billion in 2023 primarily due to higher sales in the oncology franchise, largely due to strong growth of *Keytruda* and *Welireg*, as well as increased alliance revenue from Lenvima and Lynparza.

Sales growth in 2023 was largely offset by lower sales in the virology franchise, largely due to *Lagevrio*, as well as *Isentress/Isentress HD*.

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.

Sales in the U.S. grew 5% to $28.5 billion in 2023 primarily driven by higher sales of *Keytruda*, *Vaxneuvance*, *Bridion* and *Welireg*.

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.

Spin-Off of Organon & Co.

The distribution is expected to qualify and has been treated as tax-free to the Company and its shareholders for U.S. federal income tax purposes.

Merck’s existing research pipeline programs continue to be owned and developed within Merck as planned.

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In 2022, the Company changed the treatment of certain items for purposes of its non-GAAP reporting.

Prior periods have been recast to conform to the current presentation.

Merck’s 2022 results reflect sustained strong demand for the Company’s innovative product portfolio benefiting patients globally, enabled by strong operational and commercial execution, the completion of business development transactions to support its science-led strategy, as well as progress in its pipeline across therapeutic areas, modalities and stage of development.

Sales within the Animal Health business were consistent with prior year.

As discussed below, COVID-19-related disruptions negatively affected sales in 2022, but to a lesser extent than in 2021, which benefited year-over-year sales growth.

- Exercised an option to jointly develop and commercialize personalized therapeutic cancer vaccine mRNA-4157/V940 under an existing collaboration and license agreement with Moderna, Inc. (Moderna).

- Entered into a collaboration with Orna Therapeutics (Orna), a company pioneering a new investigational class of engineered circular RNA therapies, to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology.

- Entered into a global co-development and co-commercialization agreement for Orion Corporation’s (Orion) investigational candidate ODM-208 (MK-5684) currently being evaluated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

- Entered into a license and collaboration agreement with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) for the development, manufacture and commercialization of an investigational antibody drug conjugate (ADC) (MK-1200) for the treatment of solid tumors.

- Exercised an option to obtain an exclusive license (outside of Chinese mainland, Hong Kong, Macau and Taiwan) for the development, manufacture and commercialization of Kelun-Biotech’s trophoblast antigen 2 (TROP2)-targeting ADC programs, including its lead compound SKB-264 (MK-2870).

*Keytruda* was also approved in combination with Lenvima in Japan for the treatment of certain adult patients with radically unresectable or metastatic renal cell carcinoma (RCC).

Also in 2022, *Vaxneuvance*, a vaccine to help prevent pneumococcal disease, was approved for expanded indications in the U.S. and the EU to include use in infants, adolescents and children.

Additionally in 2022, *Lyfnua* (gefapixant) was approved in Japan for adults with refractory or unexplained chronic cough.

In addition, in 2022, *Lagevrio*, which is being developed in a collaboration with Ridgeback Biotherapeutics LP (Ridgeback), received emergency conditional approval in China for the treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19.

MK-4482, *Lagevrio*, an investigational oral antiviral COVID-19 medicine, is under a rolling review by the European Medicines Agency (EMA); the Committee for Medicinal Products for Human Use of the EMA has recommended the refusal of the marketing authorization, which Merck and Ridgeback intend to appeal.

MK-7264, gefapixant, a selective, non-narcotic, orally-administered, investigational P2X3-receptor antagonist being developed for the treatment of refractory, chronic cough is under review in the U.S. and the EU.

The Company’s Phase 3 oncology programs include:

- Lenvima in combination with *Keytruda* for colorectal, esophageal, gastric, head and neck, melanoma and non-small-cell lung cancers;

- MK-3475, subcutaneous pembrolizumab for non-small-cell lung cancer (NSCLC);

- *Welireg* for RCC;

- MK-7119, Tukysa (tucatinib), which is being developed in collaboration with Seagen Inc. (Seagen), for breast and colorectal cancers; and

- MK-7962, sotatercept, for the treatment of pulmonary arterial hypertension (PAH);

During 2022, the Company returned $7.0 billion to shareholders through dividends.

War in Ukraine

In February 2022, Russia invaded Ukraine.

The Company’s primary concerns are the safety and well-being of its employees and ensuring patients and customers have continued access to medicines and vaccines needed for patient and public health.

The Company is working cross-functionally across the globe to monitor and mitigate interruptions to business continuity resulting from the war, including its impact on Merck’s supply chain, operations and clinical trials.

For humanitarian reasons, the Company is continuing to supply essential medicines and vaccines in Russia while working to maintain compliance with international sanctions.

Merck is donating profits

resulting from its operations in Russia to humanitarian causes.

The Company does not have research or manufacturing facilities in Russia, currently does not plan to make further investments in Russia, and has suspended screening and enrollment in ongoing clinical trials as well as planning for new studies in Russia, although the Company continues to treat patients already enrolled in existing clinical trials and collect data from these studies.

The Company is also using its resources to help alleviate the humanitarian crisis in Ukraine, including through donations of funds and products.

The financial impacts of the war were immaterial to the Company’s consolidated financial statements for 2022.

Sales to Russia were approximately 1% of total Merck consolidated sales for 2022 and are expected to decline in future periods.

The Company is unable to determine at this time the future direct or indirect impacts of this war on the Company’s business.

COVID-19

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The Company sells these human health vaccines primarily to physicians, wholesalers, [removed: physician] distributors and government entities.

| *($ in millions)* | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| Total Sales | | | $ | [removed: 59,283] [added: 60,115] | | | | | $ | [removed: 48,704] [added: 59,283] | | | | | $ | [removed: 41,518] [added: 48,704] | |

| Pharmaceutical | | | [removed: 52,005] [added: 53,583] | | | | | | [removed: 42,754] [added: 52,005] | | | | | | [removed: 36,610] [added: 42,754] | | |

| *Keytruda* | | | [removed: 20,937] [added: 25,011] | | | | | | [removed: 17,186] [added: 20,937] | | | | | | [removed: 14,380] [added: 17,186] | | |

| *Gardasil/Gardasil* 9 | | | [removed: 6,897] [added: 8,886] | | | | | | [removed: 5,673] [added: 6,897] | | | | | | [removed: 3,938] [added: 5,673] | | |

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

| *Januvia/Janumet* | | | [removed: 4,513] [added: 3,366] | | | | | | [removed: 5,288] [added: 4,513] | | | | | | [removed: 5,276] [added: 5,288] | | |

| *ProQuad/M-M-R* II*/Varivax* | | | [removed: 2,241] [added: 2,368] | | | | | | [removed: 2,135] [added: 2,241] | | | | | | [removed: 1,878] [added: 2,135] | | |

| *Bridion* | | | [removed: 1,685] [added: 1,842] | | | | | | [removed: 1,532] [added: 1,685] | | | | | | [removed: 1,198] [added: 1,532] | | |

| Alliance revenue - Lynparza*(1)* | | | [removed: 1,116] [added: 1,199] | | | | | | [removed: 989] [added: 1,116] | | | | | | [removed: 725] [added: 989] | | |

| Alliance revenue - Lenvima*(1)* | | | [removed: 876] [added: 960] | | | | | | [removed: 704] [added: 876] | | | | | | [removed: 580] [added: 704] | | |

| *RotaTeq* | | | [removed: 783] [added: 769] | | | | | | [removed: 807] [added: 783] | | | | | | [removed: 797] [added: 807] | | |

| Animal Health | | | [removed: 5,550] [added: 5,625] | | | | | | [removed: 5,568] [added: 5,550] | | | | | | [removed: 4,703] [added: 5,568] | | |

| Livestock | | | [removed: 3,300] [added: 3,337] | | | | | | [removed: 3,295] [added: 3,300] | | | | | | [removed: 2,939] [added: 3,295] | | |

| Companion [removed: Animals] [added: Animal] | | | [removed: 2,250] [added: 2,288] | | | | | | [removed: 2,273] [added: 2,250] | | | | | | [removed: 1,764] [added: 2,273] | | |

| Other Revenues*(2)* | | | [removed: 1,728] [added: 907] | | | | | | [removed: 382] [added: 1,728] | | | | | | [removed: 205] [added: 382] | | |

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

[added: In addition,] *Keytruda* is [removed: also] approved [added: in combination with chemotherapy] for the treatment of certain patients [added: with advanced NSCLC,] in combination with chemotherapy for [removed: metastatic squamous and non-squamous NSCLC,] [added: certain types of advanced biliary tract cancer,] in combination with chemotherapy [added: with or without bevacizumab] for [removed: HNSCC,] [added: advanced cervical cancer,] in combination with [removed: trastuzumab, fluoropyrimidine-] [added: chemotherapy for advanced esophageal cancer, in combination with trastuzumab] and [removed: platinum-containing] chemotherapy for [added: certain patients with advanced] human epidermal growth factor [added: receptor] 2 (HER2)-positive gastric or GEJ [removed: adenocarcinoma,] [added: adenocarcinoma with PD-L1 (CPS ≥1) and] in combination with [removed: platinum-and fluoropyrimidine-based] chemotherapy for [removed: esophageal] [added: advanced HER2-negative gastric] or GEJ [removed: carcinoma,] [added: adenocarcinoma,] in combination with [removed: chemotherapy,] [added: chemotherapy for HNSCC, in combination] with [removed: or without bevacizumab,] [added: chemotherapy] for advanced [removed: cervical cancer,] [added: TNBC,] in combination with [removed: chemotherapy] [added: axitinib] for [removed: locally recurrent unresectable] [added: advanced RCC, in combination with Lenvima (lenvatinib) for patients with advanced RCC] or [removed: metastatic triple-negative breast cancer (TNBC),] [added: certain types of advanced endometrial carcinoma,] and in combination with [removed: axitinib] [added: enfortumab vedotin] for [added: adult patients with locally] advanced [removed: renal cell carcinoma (RCC).][added: or metastatic urothelial cancer.]

*Keytruda* is also approved for [removed: certain] patients with high-risk [removed: early-stage TNBC] [added: 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.

*Keytruda* is [removed: also] approved [removed: as a monotherapy] for [removed: the] adjuvant treatment [removed: of certain patients with RCC, for certain patients with completely resected stage IIB, IIC or III melanoma, and for adjuvant treatment] following resection and platinum-based chemotherapy for [removed: adult] [added: certain] patients with [removed: stage IB (T2a ≥4 cm), II, or IIIA] NSCLC.

In addition, the Company recognizes alliance revenue related to sales of Lynparza (olaparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, for certain types of advanced or recurrent ovarian, early or metastatic breast, metastatic pancreatic, and metastatic castration-resistant prostate cancers; alliance revenue related to sales of [removed: Lenvima (lenvatinib),] [added: Lenvima,] an oral receptor tyrosine kinase inhibitor, for certain types of thyroid cancer, RCC, HCC, in combination with everolimus for certain patients with advanced RCC, and in combination with *Keytruda* for certain patients with advanced endometrial carcinoma or advanced RCC; and alliance revenue related to Reblozyl (luspatercept-aamt) for the treatment of certain types of anemia.

*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 [added: 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); *RotaTeq* (Rotavirus Vaccine, Live Oral, Pentavalent), a vaccine to help protect against rotavirus gastroenteritis in infants and children; [added: *Vaxneuvance* (Pneumococcal 15-valent Conjugate Vaccine), a vaccine to help prevent invasive pneumococcal disease in individuals 6 weeks of age and older;] *Pneumovax* 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal 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.

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

Adempas (riociguat), a cardiovascular drug for the treatment of chronic thromboembolic pulmonary hypertension or pulmonary arterial hypertension in certain patients; Verquvo (vericiguat), a medicine to reduce the [added: 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.]

*Nuflor* (Florfenicol) antibiotic range for use in cattle and swine; *Bovilis*/*Vista* vaccine lines for infectious diseases in cattle; *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* (Tildipirosin) for bovine respiratory disease; [removed: *Zilmax* (zilpaterol hydrochloride) and] *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* (Emamectin benzoate) parasiticide for sea lice in salmon; *Aquavac* (Avirulent Live Culture)/*Norvax* vaccines against bacterial and viral disease in fish; [removed: *Compact PD* vaccine for salmon;] *Aquaflor* (Florfenicol) antibiotic for farm-raised fish; [added: *Flexolt* (fluralaner) against lice in sheep;] and *Allflex Livestock Intelligence* solutions for animal identification, monitoring and traceability.

*Bravecto*, a line of oral and topical 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, 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 vaccination; [added: *GilvetMab*, an immune checkpoint inhibitor monoclonal antibody conditionally licensed for melanoma and mastocytoma tumors;] *Otomax* (Gentamicin sulfate, USP; Betamethasone valerate USP; and Clotrimazole USP ointment)/*Mometamax* (Gentamicin sulfate, USP, Mometasone Furoate Monohydrate and Clotrimazole, USP, Otic [removed: Suspension)/*Posatex*] [added: Suspension)/*Mometamax Ultra* (gentamicin sulfate, mometasone furoate monohydrate and posaconazole suspension)/*Posatex*] (Orbifloxacin, Mometasone Furoate Monohydrate and 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 [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*.]

[removed: 2022 Product] [added: Product] Approvals

Set forth below is a summary of significant product approvals received by the Company in [removed: 2022.][added: 2023 and, to date, in 2024.]

[removed: | August 2022 | | | MHLW approved] *Keytruda* [added: is also approved] as monotherapy for the adjuvant treatment of certain patients with [removed: RCC at increased risk of recurrence following nephrectomy, or following nephrectomy] [added: melanoma,] and [removed: resection of metastatic lesions. | | | | | |][added: for certain patients with renal cell carcinoma (RCC) post-surgery.]

[removed: | November 2022 | | | NMPA approved] [added: Additionally,] *Keytruda* [added: is approved] for [removed: the treatment of] patients with [removed: high-risk early-stage TNBC whose tumors express PD-L1,] [added: certain types of resectable NSCLC] in combination with chemotherapy as neoadjuvant treatment, and then continued as a [removed: monotherapy] [added: single agent] as adjuvant treatment after surgery. [removed: | | | | | |]

[removed: | *Lagevrio(1)* | | | December 2022 | | | NMPA granted emergency conditional approval for *Lagevrio*] [added: - MK-4482, *Lagevrio*, is an investigational oral antiviral medicine] for the treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe [removed: COVID-19. | | |][added: disease.]

| [removed: December 2022] [added: Lynparza*(1)*] | | | [removed: EC approved Lynparza] [added: May 2023 | | | FDA approval] in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with [added: deleterious or suspected deleterious *BRCA-mutated* (*BRCAm*)] metastatic castration-resistant prostate cancer [removed: (mCRPC) in whom chemotherapy is not clinically indicated. | | |] [added: (mCRPC), based on the PROpel trial.] | | |

*(1)* *Being jointly developed [added: and commercialized] in [added: a worldwide] collaboration [removed: with Ridgeback Biotherapeutics LP.*][added: with* *AstraZeneca*.]

[added: The Company is active in acquiring and] marketing products through external alliances, such as licensing arrangements and collaborations and has been refining its sales and marketing efforts to address changing industry conditions.

For example, the number of compounds available to treat a particular disease typically increases over time and can result in slowed sales growth or reduced sales [removed: for] [added: of] the Company’s products in that therapeutic category.

In addition, the Company’s sales performance in [removed: 2022] [added: 2023] was negatively affected by other cost-reduction measures taken by governments and other third parties to lower health care costs.

The Company faces increasing pricing pressure from managed care organizations, government agencies and programs that could negatively affect the Company’s sales and profit margins, including, through (i) practices of managed care organizations, federal and state exchanges, and institutional and governmental purchasers, and (ii) federal laws and regulations related to Medicare and Medicaid, including the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the Patient Protection and Affordable Care Act of 2010 (ACA), the American Rescue Plan Act of 2021 (American Rescue Plan Act), and the Inflation Reduction Act of 2022 [removed: (Inflation Reduction Act).][added: (IRA).]

[removed: In addition to formulary] tier co-pay differentials, private health insurance companies and self-insured employers have been increasing the cost-sharing required from beneficiaries, particularly for branded pharmaceuticals and biotechnology products.

In [removed: 2022,] [added: 2023,] the Company’s gross U.S. sales were reduced by [removed: 39.7%] [added: 37%] as a result of rebates, discounts and returns.

| *Vaxneuvance* | | | 665 | | | | | | 170 | | | | | | 3 | | |

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

*Welireg* (belzutifan) is a medication for the treatment of adult patients with certain von Hippel-Lindau disease-associated tumors and for the treatment of adult patients with advanced RCC following a PD-1 or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor.

[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.

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

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*.

| *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. | | |

| April 2023 | | | FDA accelerated approval in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, based on the KEYNOTE-869 trial dose escalation cohort, Cohort A and Cohort K, which was conducted in collaboration with Seagen (now Pfizer Inc. (Pfizer)) and Astellas. | | | | | |

| 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. | | | | | |

| August 2023 | | | European Commission (EC) approval in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in adults whose tumors express PD-L1, based on the KEYNOTE-811 trial. | | | | | |

| 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 | | | EC approval as a monotherapy for the adjuvant treatment of adults with NSCLC who are at high risk of recurrence following complete resection and platinum-based chemotherapy, based on the KEYNOTE-091 trial. | | | | | |

| October 2023 | | | FDA approval for the treatment of patients with resectable (tumors >=4cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery, based on the KEYNOTE-671 trial. | | | | | |

| October 2023 | | | FDA approval in combination with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer, based on the KEYNOTE-966 trial. | | | | | |

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

| *Keytruda* | | | November 2023 | | | FDA approval in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma, based on the KEYNOTE-859 trial. | | |

| 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. | | | | | |

| December 2023 | | | EC approval in combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults, based on the KEYNOTE-966 trial. | | | | | |

| December 2023 | | | China’s NMPA approval in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma, based on the KEYNOTE-859 trial. | | | | | |

| January 2024 | | | FDA approval in combination with chemoradiotherapy for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) stage III-IVA cervical cancer, based on the KEYNOTE-A18 trial. | | | | | |

| January 2024 | | | FDA full approval for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1 containing regimen. The conversion from an accelerated to full (regular) approval is based on the KEYNOTE-394 trial. | | | | | |

| February 2024 | | | China’s NMPA approval in combination with gemcitabine and cisplatin for the first-line treatment of patients with locally advanced or metastatic biliary tract carcinoma, based on the KEYNOTE-966 trial. | | | | | |

| August 2023 | | | Japan’s MHLW approval in combination with abiraterone and prednisolone for treatment of adult patients with *BRCAm* mCRPC with distant metastasis, 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. | | |

| *Bravecto* | | | January 2024 | | | EC approval of injectable formulation for dogs for the persistent killing of fleas and ticks for 12 months after treatment. | | |

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

In addition to formulary

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

In August 2023, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced that *Januvia* will be included in the first year of the IRA’s “Drug Price Negotiation Program” (Program).

Pursuant to the IRA’s Program, discussions with the government occurred in 2023 and will continue in 2024, with government price setting becoming effective on January 1, 2026.

The Company has sued the U.S. government regarding the IRA’s Program (see Item 8 “Financial Statements and Supplementary Data,” Note 11.

“Contingencies and Environmental Liabilities” below).

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

In addition, recently, the FDA authorized, for a two-year period, Florida’s application to import prescription drugs from Canada.

Merck’s existing research pipeline programs continue to be owned and developed within Merck as planned.

| *Simponi* | | | 706 | | | | | | 825 | | | | | | 838 | | |

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

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.

| *Keytruda* | | | January 2022 | | | European Commission (EC) approved *Keytruda* as monotherapy for the adjuvant treatment of adults with RCC at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. | | |

| February 2022 | | | Japan’s Ministry of Health, Labor and Welfare (MHLW) approved *Keytruda* plus Lenvima for radically unresectable or metastatic RCC. | | | | | |

| February 2022 | | | MHLW approved *Keytruda* for the treatment of adult patients with advanced or recurrent TMB-H solid tumors that have progressed after chemotherapy (limited to use when difficult to treat with standard of care). | | | | | |

| March 2022 | | | U.S. Food and Drug Administration (FDA) approved *Keytruda* as a single agent for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. | | | | | |

| April 2022 | | | EC approved *Keytruda* in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer in certain adults whose tumors express PD-L1. | | | | | |

| April 2022 | | | EC approved *Keytruda* as monotherapy for the treatment of certain patients with unresectable or metastatic MSI-H/dMMR colorectal, gastric, small intestine or biliary cancer, as well as advanced or recurrent MSI-H/dMMR endometrial carcinoma. | | | | | |

| May 2022 | | | EC approved *Keytruda* in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage TNBC at high risk of recurrence. | | | | | |

| *Keytruda* | | | June 2022 | | | EC approved *Keytruda* as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. Additionally, EC approved expanded indications in advanced (unresectable or metastatic) melanoma and stage III melanoma with lymph node involvement (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older. | | |

| September 2022 | | | MHLW approved *Keytruda* in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for patients with hormone receptor-negative and HER2-negative breast cancer at high risk of recurrence. | | | | | |

| September 2022 | | | MHLW approved *Keytruda* in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with advanced or recurrent cervical cancer with no prior chemotherapy who are not amenable to curative treatment. | | | | | |

| September 2022 | | | MHLW approved *Keytruda* as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection. | | | | | |

| October 2022 | | | China’s National Medical Products Administration (NMPA) approved *Keytruda* as monotherapy for the treatment of patients with HCC who have been previously treated with sorafenib or oxaliplatin-based chemotherapy. | | | | | |

| Lynparza*(2)* | | | March 2022 | | | FDA approved Lynparza 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 treated with neoadjuvant or adjuvant chemotherapy. | | |

| August 2022 | | | MHLW approved Lynparza for the adjuvant treatment for patients with *BRCA*\-mutated, HER2-negative high recurrent risk breast cancer. | | | | | |

| August 2022 | | | EC approved Lynparza as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. | | | | | |

| September 2022 | | | NMPA approved Lynparza as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. | | | | | |

| *Vaxneuvance* | | | June 2022 | | | FDA approved an expanded indication for *Vaxneuvance* (Pneumococcal 15-valent Conjugate Vaccine) to include children 6 weeks through 17 years of age. *Vaxneuvance* is now indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older. | | |

| September 2022 | | | MHLW approved *Vaxneuvance* for prevention of infections caused by Streptococcus pneumoniae in the elderly or adults who are considered at increased risk for disease caused by Streptococcus pneumoniae. | | | | | |

| October 2022 | | | EC approved an expanded indication for *Vaxneuvance* to include active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. | | | | | |

*(2)* *Being jointly developed and commercialized in a worldwide collaboration with* *AstraZeneca*.

The Company is active in acquiring and

the liability for certain drug benefits, and government price-setting for certain Medicare Part D drugs, starting in 2026, and Medicare Part B drugs starting in 2028.

In November 2020, the Department of Health and Human Services Office of Inspector General issued a Final Rule that would have, effective January 1, 2023, eliminated the Anti-Kickback Statute safe harbor for rebates paid to Medicare Part D plans or to PBMs on behalf of such plans.

Congress has delayed implementation of this Final Rule until January 1, 2026 and pending federal legislation would repeal it entirely.

While the Company cannot anticipate the effects of this change to the way it currently contracts, this new framework could significantly alter the way it does business with Part D Plan Sponsors and PBMs on behalf of such plans.

This rulemaking also established, effective January 1, 2021, a new safe harbor for point of sale discounts at the pharmacy counter and a new safe harbor for certain service arrangements between pharmaceutical manufacturers and PBMs.

most EU Member States.

In 2021, drugs were added to the NRDL with an average of more than 60% price reductions.

developments that may adversely impact the business environment for the Company.

The Company systematically evaluates its pipeline candidates to identify potential to address significant public health burden and unmet medical needs in underserved health care settings.

The Company also collaborates with different stakeholders,

The uncertainty regarding the interplay between

Current U.S. patent law provides additional patent term for periods when the patented product was under regulatory review by the FDA.

| Verquvo*(10)* | | | 2035 (with pending PTE) | | | | | | N/A*(12)* | | | | | | N/A*(12)* | | | | | | N/A*(12)* | | |

| *Recarbrio* | | | 2033*(8)* (with pending PTE) | | | | | | 2029 (patents), 2034 (SPCs) | | | | | | 2034 (with pending PTE) | | | | | | N/A | | |

*(12)The Company has no marketing rights in the EU, Japan or China.*

As filed with the Securities and Exchange Commission on February [removed: 24, 2023][added: 26, 2024]

For the Fiscal Year Ended December 31, [removed: 2022][added: 2023]

[removed: ][added: ]

| (State or other jurisdiction of incorporation) | | | [removed: (I.R.S] [added: (I.R.S.] Employer Identification No.) | | | | | |

Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, [removed: 2023: 2,538,592,467.][added: 2024: 2,532,643,872.]

Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, [removed: 2022] [added: 2023] based on the closing price on June 30, [removed: 2022: $230,820,000,000.][added: 2023: $292,929,000,000.]

| Proxy Statement for the Annual Meeting of Shareholders to be held May [removed: 23, 2023,] [added: 18, 2024,] 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](#ia384118d157240e09e39541b90e2080f_13)] [added: [Business](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_13)] | | | | | | [removed: [1](#ia384118d157240e09e39541b90e2080f_13)] [added: [1](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_13)] | | |

| Item 1A. | | | [Risk [removed: Factors](#ia384118d157240e09e39541b90e2080f_52)] [added: Factors](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_49)] | | | | | | [removed: [24](#ia384118d157240e09e39541b90e2080f_52)] [added: [25](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_49)] | | |

| | | | [Cautionary Factors that May Affect Future [removed: Results](#ia384118d157240e09e39541b90e2080f_55)] [added: Results](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_52)] | | | | | | [removed: [38](#ia384118d157240e09e39541b90e2080f_55)] [added: [38](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_52)] | | |

| Item 1B. | | | [Unresolved Staff [removed: Comments](#ia384118d157240e09e39541b90e2080f_58)] [added: Comments](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_55)] | | | | | | [removed: [39](#ia384118d157240e09e39541b90e2080f_58)] [added: [39](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_55)] | | |

| Item 2. | | | [removed: [Properties](#ia384118d157240e09e39541b90e2080f_61)] [added: [Properties](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_58)] | | | | | | [removed: [39](#ia384118d157240e09e39541b90e2080f_61)] [added: [40](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_58)] | | |

| Item 3. | | | [Legal [removed: Proceedings](#ia384118d157240e09e39541b90e2080f_64)] [added: Proceedings](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_61)] | | | | | | [removed: [39](#ia384118d157240e09e39541b90e2080f_64)] [added: [40](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_61)] | | |

| Item 4. | | | [Mine Safety [removed: Disclosures](#ia384118d157240e09e39541b90e2080f_67)] [added: Disclosures](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_64)] | | | | | | [removed: [39](#ia384118d157240e09e39541b90e2080f_67)] [added: [40](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_64)] | | |

| | | | [Executive Officers of the [removed: Registrant](#ia384118d157240e09e39541b90e2080f_70)] [added: Registrant](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_67)] | | | | | | [removed: [40](#ia384118d157240e09e39541b90e2080f_70)] [added: [41](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_67)] | | |

| Item 5. | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#ia384118d157240e09e39541b90e2080f_76)] [added: Securities](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_73)] | | | | | | [removed: [41](#ia384118d157240e09e39541b90e2080f_76)] [added: [42](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_73)] | | |

| Item 6. | | | [removed: [\[Reserved\]](#ia384118d157240e09e39541b90e2080f_2209)] [added: [\[Reserved\]](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_76)] | | | | | | [removed: [42](#ia384118d157240e09e39541b90e2080f_2209)] [added: [43](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_76)] | | |

| Item 7. | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#ia384118d157240e09e39541b90e2080f_79)] [added: Operations](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_79)] | | | | | | [removed: [43](#ia384118d157240e09e39541b90e2080f_79)] [added: [44](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_79)] | | |

| Item 7A. | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#ia384118d157240e09e39541b90e2080f_121)] [added: Risk](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_121)] | | | | | | [removed: [70](#ia384118d157240e09e39541b90e2080f_121)] [added: [70](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_121)] | | |

| Item 8. | | | [Financial Statements and Supplementary [removed: Data](#ia384118d157240e09e39541b90e2080f_124)] [added: Data](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_124)] | | | | | | [removed: [71](#ia384118d157240e09e39541b90e2080f_124)] [added: [71](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_124)] | | |

| | | | (a) | | | [Financial [removed: Statements](#ia384118d157240e09e39541b90e2080f_127)] [added: Statements](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_127)] | | | [removed: [71](#ia384118d157240e09e39541b90e2080f_127)] [added: [71](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_127)] | | |

| | | | | | | [Notes to Consolidated Financial [removed: Statements](#ia384118d157240e09e39541b90e2080f_142)] [added: Statements](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_142)] | | | [removed: [75](#ia384118d157240e09e39541b90e2080f_142)] [added: [75](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_142)] | | |

| | | | | | | [Report of Independent Registered Public Accounting [removed: Firm](#ia384118d157240e09e39541b90e2080f_208)] [added: Firm](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_208)] | | | [removed: [128](#ia384118d157240e09e39541b90e2080f_208)] [added: [127](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_208)] | | |

| Item 9. | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#ia384118d157240e09e39541b90e2080f_214)] [added: Disclosure](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_211)] | | | | | | [removed: [130](#ia384118d157240e09e39541b90e2080f_214)] [added: [129](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_211)] | | |

| Item 9A. | | | [Controls and [removed: Procedures](#ia384118d157240e09e39541b90e2080f_217)] [added: Procedures](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_214)] | | | | | | [removed: [130](#ia384118d157240e09e39541b90e2080f_217)] [added: [129](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_214)] | | |

| Item 9B. | | | [Other [removed: Information](#ia384118d157240e09e39541b90e2080f_223)] [added: Information](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_220)] | | | | | | [removed: [131](#ia384118d157240e09e39541b90e2080f_223)] [added: [130](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_220)] | | |

| Item 9C. | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#ia384118d157240e09e39541b90e2080f_226)] [added: Inspections](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_223)] | | | | | | [removed: [131](#ia384118d157240e09e39541b90e2080f_226)] [added: [130](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_223)] | | |

| Item 10. | | | [Directors, Executive Officers and Corporate [removed: Governance](#ia384118d157240e09e39541b90e2080f_232)] [added: Governance](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_229)] | | | | | | [removed: [132](#ia384118d157240e09e39541b90e2080f_232)] [added: [131](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_229)] | | |

| Item 11. | | | [Executive [removed: Compensation](#ia384118d157240e09e39541b90e2080f_235)] [added: Compensation](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_232)] | | | | | | [removed: [132](#ia384118d157240e09e39541b90e2080f_235)] [added: [131](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_232)] | | |

| Item 12. | | | [Security Ownership of Certain Beneficial Owners and Management and [removed: Related](#ia384118d157240e09e39541b90e2080f_238)[ ](#ia384118d157240e09e39541b90e2080f_238)[Stockholder Matters](#ia384118d157240e09e39541b90e2080f_238)] [added: Related](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_235)[ ](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_235)[Stockholder Matters](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_235)] | | | | | | [removed: [133](#ia384118d157240e09e39541b90e2080f_238)] [added: [132](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_235)] | | |

| Item 13. | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#ia384118d157240e09e39541b90e2080f_241)] [added: Independence](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_238)] | | | | | | [removed: [133](#ia384118d157240e09e39541b90e2080f_241)] [added: [132](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_238)] | | |

| Item 14. | | | [Principal Accountant Fees and [removed: Services](#ia384118d157240e09e39541b90e2080f_244)] [added: Services](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_241)] | | | | | | [removed: [133](#ia384118d157240e09e39541b90e2080f_244)] [added: [132](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_241)] | | |

| Item 15. | | | [Exhibits and Financial Statement [removed: Schedules](#ia384118d157240e09e39541b90e2080f_250)] [added: Schedules](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_247)] | | | | | | [removed: [134](#ia384118d157240e09e39541b90e2080f_250)] [added: [133](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_247)] | | |

| Item 16. | | | [Form 10-K [removed: Summary](#ia384118d157240e09e39541b90e2080f_262)] [added: Summary](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_259)] | | | | | | [removed: [138](#ia384118d157240e09e39541b90e2080f_262)] [added: [137](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_259)] | | |

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

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

| Item 1C. | | | [Cybersecurity](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_2135) | | | | | | [39](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_2135) | | |

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

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

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

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

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

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

(MARK ONE)

(Check One):

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

| [Part I](#ia384118d157240e09e39541b90e2080f_10) | | | | | | | | | | | |

| [Part II](#ia384118d157240e09e39541b90e2080f_73) | | | | | | | | | | | |

| | | | [Management’s Report](#ia384118d157240e09e39541b90e2080f_220) | | | | | | [130](#ia384118d157240e09e39541b90e2080f_220) | | |

| [Part III](#ia384118d157240e09e39541b90e2080f_223) | | | | | | | | | | | |

| [Part IV](#ia384118d157240e09e39541b90e2080f_247) | | | | | | | | | | | |

| | | | [Signatures](#ia384118d157240e09e39541b90e2080f_265) | | | | | | [139](#ia384118d157240e09e39541b90e2080f_265) | | |

The Company’s cybersecurity measures are primarily focused on ensuring the security and protection of its information technology systems and data.

The Company’s information security program is managed by a dedicated Chief Information Security Officer (CISO), whose group is responsible for leading enterprise-wide cybersecurity risk management, strategy, policy, standards, architecture, and processes.

The CISO has worked in the cybersecurity and national security fields for more than 30 years.

He has a Master of Science in Telecommunications and Computers.

He has served as a board member of the Health Information Sharing and Analysis Center for 10 years.

Oversight of the information security program has been integrated into the Company’s overall enterprise risk management program.

The CISO provides periodic reports to the Audit Committee (Audit Committee) of the Board of Directors (Board), the full Board, as well as to the Company’s Chief Executive Officer and other members of senior management, as appropriate.

These reports include updates on the Company’s cybersecurity risks and threats, the status of projects intended to strengthen its information security systems, assessments of the information security program (including remediation, mitigation, and management of identified vulnerabilities), and the emerging threat landscape.

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)

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.

The Company’s information security group monitors the Company’s information systems to prevent, detect, mitigate, and remediate cybersecurity incidents.

The Company uses tools and techniques to continually assess and monitor, manage and mitigate cybersecurity threats to its IT systems in a manner consistent with industry practice.

The Company engages with key vendors, industry participants, and intelligence and law enforcement communities as part of its continuing efforts to obtain current threat intelligence, collaborate on security enhancements, and evaluate and improve the effectiveness of its information security program.

As part of this program, the Company conducts periodic tabletop exercises to assess its cybersecurity incident response processes.

The Company also maintains vendor management diligence and oversight processes to identify and monitor potential risks from cybersecurity threats attendant to its use of third-party service providers.

Additionally, the Company monitors cybersecurity threat intelligence received from key third-party service providers associated with the Company.

In the event of a cybersecurity incident, the Company has a process in place whereby members of the 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.

If warranted, senior management will notify the Audit Committee or the full Board, as appropriate.

The Company has been and continues to be the target of cyber-attacks and network disruptions.

To date, the risks posed by such cybersecurity threats have not materially affected the Company and its business strategy, results of operations and financial condition, and as of the date of this report, the Company is not aware of any material risks from cybersecurity threats that are reasonably likely to do so, but there can be no assurance that the Company will not be materially affected by such risks in the future.

For further information, see Item 1A.

“Risk Factors — The Company is increasingly dependent on sophisticated software applications and computing infrastructure.

The Company continues to be a target of cyber-attacks that could lead to a disruption of its worldwide operations, including manufacturing, research and sales operations.”

The Company’s corporate headquarters [removed: is currently] [added: are] located in [removed: Kenilworth,] [added: Rahway,] New Jersey.

The Company also maintains [removed: operational or] divisional headquarters in [removed: Kenilworth, New Jersey; Madison, New Jersey and] Upper Gwynedd, Pennsylvania.

The Company also has production facilities for human health products at [removed: seven] [added: six] locations in the U.S. and Puerto Rico.

Outside the U.S., through subsidiaries, the Company owns or has an interest in manufacturing plants or other properties in [removed: Japan, Singapore, South Africa, and other countries in] Western Europe, [removed: Central and South America,] [added: Africa] and Asia.

The Company has previously announced that it intends to consolidate its New Jersey campuses into a single corporate headquarters location in Rahway, New Jersey by the end of 2023.

Executive Officers of the Registrant (ages as of February 1, [removed: 2023)][added: 2024)]

| Robert M. Davis | | | [removed: 56] [added: 57] | | | Chairman, [removed: President and] Chief Executive Officer [added: 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: 63] [added: 64] | | | Executive Vice President and President, Merck Manufacturing Division (since March 2016) | | |

| Richard R. DeLuca, Jr. | | | [removed: 60] [added: 61] | | | Executive Vice President and President, Merck Animal Health (since September 2011) | | |

| Cristal Downing | | | [removed: 54] [added: 55] | | | Executive Vice President and Chief Communications & Public Affairs Officer (since August 2021); [added: 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 [removed: 2020); Prior to that, Senior Director Communications at Johnson & Johnson] [added: 2020)] | | |

| Chirfi Guindo | | | [removed: 57] [added: 58] | | | 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 [removed: 2022); Executive Vice President, Head of Global Marketing, Market Access and Customer Innovation, Biogen Inc. (November 2017-June 2018)] [added: 2022)] | | |

| [removed: Rita A. Karachun] [added: Dalton Smart] | | | [removed: 59] [added: 57] | | | Senior Vice President Finance [removed: -] [added: –] Global Controller (since [removed: March 2014)] [added: December 2023); Vice President, Assistant Controller (September 2023-December 2023); Vice President, Internal Audit (March 2015-September 2023)] | | |

| Michael A. Klobuchar | | | [removed: 47] [added: 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 [removed: 2021); Senior Vice President of Corporate Strategy and Planning and President of Emerging Businesses (December 2017-January 2019)] [added: 2021)] | | |

| Dean Li | | | [removed: 60] [added: 61] | | | Executive Vice President, President, Merck Research Laboratories (since January 2021); Senior Vice President, Discovery Sciences and Translational Medicine, Merck Research Laboratories (November 2017-January [removed: 2021); Vice President, Translational Medicine (March 2017-November 2017)] [added: 2021)] | | |

| Caroline Litchfield | | | [removed: 54] [added: 55] | | | Executive Vice President and Chief Financial Officer (since April 2021); Senior Vice President, Corporate Treasurer (January 2018-March 2021) | | |

| Steven C. Mizell | | | [removed: 62] [added: 63] | | | Executive Vice President, Chief Human Resources Officer (since October [removed: 2018); Prior to that, Executive Vice President, Human Resources, Monsanto Company] [added: 2018)] | | |

| Johannes J. Oosthuizen | | | [removed: 55] [added: 56] | | | 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: 49] [added: 50] | | | Senior Vice President and President MSD International Human Health (since July 2022); [added: Prior to that,] Chief Executive Officer JiXing Pharmaceuticals (July 2021-July 2022); President MSD China (December 2016-July 2021) | | |

| David M. Williams | | | [removed: 54] [added: 55] | | | Executive Vice President, Chief Information and Digital Officer (since August 2020); Acting Chief Information and Digital Officer (December 2019-August 2020); Vice President and Chief Information Officer, Merck Animal Health (May 2017-December 2019) | | |

| Jennifer Zachary | | | [removed: 45] [added: 46] | | | Executive Vice [removed: President, General Counsel and Corporate Secretary (since January 2020); Executive Vice] President and General Counsel [removed: (April 2018-January 2020); Prior to that, Partner, Covington & Burling LLP] [added: (since April 2018)] | | |

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

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.

| | | | | | | | | |

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

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

| Betty D. Larson | | | 48 | | | Chief People Officer, GE HealthCare (since February 2022); Executive Vice President and Chief Human Resources Officer, Becton Dickinson (June 2018-February 2022) | | |

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

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

| Lisa LeCointe-Cephas | | | 41 | | | Senior Vice President, Chief Ethics and Compliance Officer (since April 2021); Executive Director, Head of Global Investigations (February 2018-April 2021); Prior to that, Senior Counsel, Litigation and Government Investigations, Bristol-Myers Squibb Company | | |

As of January 31, [removed: 2023,] [added: 2024,] there were approximately [removed: 95,850] [added: 90,400] shareholders of record of the Company’s Common Stock.

Issuer purchases of equity securities for the three months ended December 31, [removed: 2022] [added: 2023] were as follows:

*(1)* [removed: *The Company did not purchase any] [added: *All] shares [added: purchased] during the [removed: three months ended December 31, 2022 under the] [added: 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 treasury.*

The following graph assumes a $100 investment on December 31, [removed: 2017,] [added: 2018,] 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: 2022/2017 CAGR*] [added: 2023/2018 CAGR*] | | |

[removed: ][added: ]

| | | | [removed: 2017 | | |] 2018 | | | 2019 | | | 2020 | | | 2021 | | | 2022 | | | [added: 2023 | | |]

* Peer group average was calculated on a market cap weighted basis as of December 31, [removed: 2017.*][added: 2018.*]

| 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% | | |

| PEER GROUP | | | 171 | | | | | | 11% | | |

| 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 | | |

| October 1 — October 31 | | | | | | — | | | | | | — | | | | | | — | | | | | | $5,047 | | |

| November 1 — November 30 | | | | | | — | | | | | | — | | | | | | — | | | | | | $5,047 | | |

| December 1 — December 31 | | | | | | — | | | | | | — | | | | | | — | | | | | | $5,047 | | |

| Total | | | | | | — | | | | | | — | | | | | | — | | | | | | | | |

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

| MERCK | | | $242 | | | | | | 19% | | |

| PEER GROUP | | | 175 | | | | | | 12% | | |

| S&P 500 | | | 157 | | | | | | 9% | | |

| MERCK | | | 100.0 | | | 140.0 | | | 171.2 | | | 158.8 | | | 161.7 | | | 241.5 | | |

| PEER GROUP | | | 100.0 | | | 106.1 | | | 125.7 | | | 134.2 | | | 164.8 | | | 174.8 | | |

| S&P 500 | | | 100.0 | | | 95.6 | | | 125.7 | | | 148.8 | | | 191.5 | | | 156.8 | | |

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

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

The consolidated balance sheet of Merck & Co., Inc. and subsidiaries as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the related consolidated statements of income, of comprehensive [added: (loss)] income, of equity and of cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] the notes to consolidated financial statements, and the report dated February [removed: 24, 2023] [added: 26, 2024] of PricewaterhouseCoopers LLP, independent registered public accounting firm, are as follows:

| | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| Sales | | | $ | [removed: 59,283] [added: 60,115] | | | | | $ | [removed: 48,704] [added: 59,283] | | | | | $ | [removed: 41,518] [added: 48,704] | |

| Cost of sales | | | [removed: 17,411] [added: 16,126] | | | | | | [removed: 13,626] [added: 17,411] | | | | | | [removed: 13,618] [added: 13,626] | | |

| Selling, general and administrative | | | [removed: 10,042] [added: 10,504] | | | | | | [removed: 9,634] [added: 10,042] | | | | | | [removed: 8,955] [added: 9,634] | | |

| Research and development | | | [removed: 13,548] [added: 30,531] | | | | | | [removed: 12,245] [added: 13,548] | | | | | | [removed: 13,397] [added: 12,245] | | |

| Restructuring costs | | | [removed: 337] [added: 599] | | | | | | [removed: 661] [added: 337] | | | | | | [removed: 575] [added: 661] | | |

| Other (income) expense, net | | | [removed: 1,501] [added: 466] | | | | | | [removed: (1,341)] [added: 1,501] | | | | | | [removed: (890)] [added: (1,341)] | | |

| | | | [removed: 42,839] [added: 58,226] | | | | | | [removed: 34,825] [added: 42,839] | | | | | | [removed: 35,655] [added: 34,825] | | |

| Income from Continuing Operations Before Taxes | | | [removed: 16,444] [added: 1,889] | | | | | | [removed: 13,879] [added: 16,444] | | | | | | [removed: 5,863] [added: 13,879] | | |

| Taxes on Income from Continuing Operations | | | [removed: 1,918] [added: 1,512] | | | | | | [removed: 1,521] [added: 1,918] | | | | | | [removed: 1,340] [added: 1,521] | | |

| Net Income from Continuing Operations | | | [removed: 14,526] [added: 377] | | | | | | [removed: 12,358] [added: 14,526] | | | | | | [removed: 4,523] [added: 12,358] | | |

| Less: Net Income Attributable to Noncontrolling Interests | | | [removed: 7] [added: 12] | | | | | | [removed: 13] [added: 7] | | | | | | [removed: 4] [added: 13] | | |

| Net Income from Continuing Operations Attributable to Merck & Co., Inc. | | | [removed: 14,519] [added: 365] | | | | | | [removed: 12,345] [added: 14,519] | | | | | | [removed: 4,519] [added: 12,345] | | |

| Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests | | | — | | | | | | [removed: 704] [added: —] | | | | | | [removed: 2,548] [added: 704] | | |

| Net Income Attributable to Merck & Co., Inc. | | | $ | [removed: 14,519] [added: 365] | | | | | $ | [removed: 13,049] [added: 14,519] | | | | | $ | [removed: 7,067] [added: 13,049] | |

| Income from Continuing Operations | | | $ | [removed: 5.73] [added: 0.14] | | | | | $ | [removed: 4.88] [added: 5.73] | | | | | $ | [removed: 1.79] [added: 4.88] | |

| Income from Discontinued Operations | | | — | | | | | | [removed: 0.28] [added: —] | | | | | | [removed: 1.01] [added: 0.28] | | |

| Net Income | | | $ | [removed: 5.73] [added: 0.14] | | | | | $ | [removed: 5.16] [added: 5.73] | | | | | $ | [removed: 2.79] [added: 5.16] | |

| Income from Continuing Operations | | | $ | [removed: 5.71] [added: 0.14] | | | | | $ | [removed: 4.86] [added: 5.71] | | | | | $ | [removed: 1.78] [added: 4.86] | |

| Income from Discontinued Operations | | | — | | | | | | [removed: 0.28] [added: —] | | | | | | [removed: 1.00] [added: 0.28] | | |

| Net Income | | | $ | [removed: 5.71] [added: 0.14] | | | | | $ | [removed: 5.14] [added: 5.71] | | | | | $ | [removed: 2.78] [added: 5.14] | |

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

| Net unrealized (loss) gain on derivatives, net of reclassifications | | | [removed: (71)] [added: (97)] | | | | | | [removed: 410] [added: (71)] | | | | | | [removed: (297)] [added: 410] | | |

| Benefit plan net [removed: gain] (loss) [added: gain] and prior service [removed: credit (cost),] [added: (cost) credit,] net of amortization | | | [removed: 335] [added: (385)] | | | | | | [removed: 1,769] [added: 335] | | | | | | [removed: (279)] [added: 1,769] | | |

| Cumulative translation adjustment | | | [removed: (603)] [added: 89] | | | | | | [removed: (423)] [added: (603)] | | | | | | [removed: 153] [added: (423)] | | |

| | | | [removed: (339)] [added: (393)] | | | | | | [removed: 1,756] [added: (339)] | | | | | | [removed: (441)] [added: 1,756] | | |

| Comprehensive [added: (Loss)] Income Attributable to Merck & Co., Inc. | | | $ | [removed: 14,180] [added: (28)] | | | | | $ | [removed: 14,805] [added: 14,180] | | | | | $ | [removed: 6,626] [added: 14,805] | |

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

| Cash and cash equivalents | | | $ | [removed: 12,694] [added: 6,841] | | | | | $ | [removed: 8,096] [added: 12,694] | |

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

| Accounts receivable (net of allowance for doubtful accounts of [removed: $72] [added: $88] in [removed: 2022] [added: 2023] and [removed: $62] [added: $72] in [removed: 2021)] [added: 2022)] | | | [removed: 9,450] [added: 10,349] | | | | | | [removed: 9,230] [added: 9,450] | | |

| Inventories (excludes inventories of [removed: $2,938] [added: $3,348] in [removed: 2022] [added: 2023] and [removed: $2,194] [added: $2,938] in [removed: 2021] [added: 2022] classified in Other assets - see Note 8) | | | [removed: 5,911] [added: 6,358] | | | | | | [removed: 5,953] [added: 5,911] | | |

| Other current assets | | | [removed: 7,169] [added: 8,368] | | | | | | [removed: 6,987] [added: 7,169] | | |

| Total current assets | | | [removed: 35,722] [added: 32,168] | | | | | | [removed: 30,266] [added: 35,722] | | |

| Investments | | | [removed: 1,015] [added: 252] | | | | | | [removed: 370] [added: 1,015] | | |

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

| Buildings | | | [removed: 13,166] [added: 14,966] | | | | | | [removed: 12,529] [added: 13,166] | | |

| Machinery, equipment and office furnishings | | | [removed: 16,760] [added: 17,763] | | | | | | [removed: 16,303] [added: 16,760] | | |

| Construction in progress | | | [removed: 9,186] [added: 8,262] | | | | | | [removed: 8,313] [added: 9,186] | | |

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

| | | | 2023 | | | | | | 2022 | | |

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

| | | | 23,051 | | | | | | 21,422 | | |

| | | | $ | 106,675 | | | | | $ | 109,160 | |

| | | | $ | 106,675 | | | | | $ | 109,160 | |

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

| Net income attributable to Merck & Co., Inc. | | | — | | | | | | — | | | | | | 365 | | | | | | — | | | | | | — | | | | | | — | | | | | | 365 | | |

| Balance December 31, 2023 | | | $ | 1,788 | | | | | $ | 44,509 | | | | | $ | 53,895 | | | | | $ | (5,161) | | | | | $ | (57,450) | | | | | $ | 54 | | | | | $ | 37,635 | |

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

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

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

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

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

accounting guidance.

Payment terms for vaccines sales in the U.S. typically range from 30 to 60 days.

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

Research and

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

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

*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 includes exceptions to fair value measurement that are consistent with the accounting for business combinations guidance.

The amended guidance is effective prospectively for all joint ventures with a formation date on or after January 1, 2025, however existing joint ventures have the option to apply the guidance retrospectively.

In November 2023, the FASB issued guidance intended to improve reportable segment disclosure requirements, primarily through expanded disclosures for significant segment expenses.

Early adoption is permitted.

The guidance will result in incremental disclosures to the Company’s segment reporting disclosures.

In December 2023, the FASB issued guidance intended to improve the transparency of income tax disclosures by requiring consistent categories and disaggregation of information in the effective income tax rate reconciliation and income taxes paid disclosures by jurisdiction.

The guidance also includes other amendments to improve the effectiveness of income tax disclosures by removing certain previously required disclosures.

The guidance is effective for 2025 annual reporting.

Early adoption is permitted.

Recent Transactions

In February 2024, Merck entered into a definitive agreement to acquire the aqua business of Elanco Animal Health Incorporated (Elanco) for $1.3 billion in cash.

The Elanco aqua business to be acquired consists of an

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

innovative portfolio of medicines and vaccines, nutritionals and supplements for aquatic species; two related aqua manufacturing facilities in Canada and Vietnam; as well as a research facility in Chile.

Upon closing, the acquisition will broaden Merck Animal Health’s aqua portfolio with products, such as Clynav, a new generation DNA-based vaccine that protects Atlantic salmon against pancreas disease, and Imvixa, an anti-parasitic sea lice treatment.

This acquisition also brings a portfolio of water treatment products for warm water production, complementing Merck Animal Health’s warm water vaccine portfolio.

In addition to these products, the DNA-based vaccine technology that is a part of the business has the potential to accelerate the development of novel vaccines to address the unmet needs of the aqua industry.

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

In January 2024, Merck entered into an agreement to acquire Harpoon Therapeutics, Inc. (Harpoon), a clinical-stage immunotherapy company developing a novel class of T-cell engagers designed to harness the power of the body’s immune system to treat patients suffering from cancer and other diseases.

| Net unrealized loss on investments, net of reclassifications | | | — | | | | | | — | | | | | | (18) | | |

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

| | | | 39,407 | | | | | | 37,471 | | |

| | | | $ | 109,160 | | | | | $ | 105,694 | |

| Balance January 1, 2020 | | | $ | 1,788 | | | | | $ | 39,660 | | | | | $ | 46,602 | | | | | $ | (6,193) | | | | | $ | (55,950) | | | | | $ | 94 | | | | | $ | 26,001 | |

Merck’s existing research pipeline programs continue to be owned and developed within Merck as planned.

goodwill will be recorded.

*and BioTerror Countermeasures to the Federal Government for Placement into the Pediatric Vaccine Stockpile or the Strategic National Stockpile*.

Some customers have bill-and-hold arrangements with the Company.

Revenue for bill-and-hold arrangements is recognized when control transfers to the customer even though the customer does not yet have physical possession of the goods.

Control transfers when the bill-and-hold arrangement has been requested by the customer, the product is identified as belonging to the customer and is ready for physical transfer, the product cannot be directed for use by anyone but the customer and, in certain circumstances, the customer has inspected and accepted the product at the Company’s facility.

The contracted customer generally purchases product from the wholesaler at its contracted price plus a mark-up.

expensed when the activity has been performed or when the goods have been received rather than when the payment is made.

*Recently Adopted Accounting Standards —* In August 2020, the Financial Accounting Standards Board (FASB) issued amended guidance on the accounting for convertible instruments and contracts in an entity’s own equity.

The guidance removes the separation model for convertible debt instruments and preferred stock, amends requirements for conversion options to be classified in equity as well as amends diluted earnings per share (EPS) calculations for certain convertible debt instruments.

The Company adopted the new guidance on January 1, 2022 using a modified retrospective approach.

In November 2021, the FASB issued new guidance to increase the transparency of transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy.

The guidance requires annual disclosures of such transactions to include the nature of the transactions and the significant terms and conditions, the accounting treatment and the impact to a company’s financial statements.

The Company adopted the new guidance on January 1, 2022 on a prospective basis.

In March 2020, the FASB issued optional guidance to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting and subsequently issued clarifying amendments.

The guidance provides optional expedients and exceptions for accounting for contracts, hedging relationships, and other transactions that reference the London Interbank Offered Rate (LIBOR) or another reference rate expected to be discontinued because of reference rate reform.

The distribution is expected to qualify and has been treated as tax free to Merck and its shareholders for U.S. federal income tax purposes.

Recently Completed Transactions

There are no future contingent payments associated with the acquisition.

mRNA-4157/V940 is currently being evaluated in combination with *Keytruda* (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with stage III/IV melanoma following complete resection in a Phase 2 clinical trial being conducted by Moderna.

Upon option

Sotatercept is in Phase 3 trials as an add-on to current standard of care for the treatment of PAH.

In addition to sotatercept, Acceleron’s portfolio includes Reblozyl (luspatercept), a first-in-class erythroid maturation recombinant fusion protein that is approved in the U.S., Europe, and certain other markets for the treatment of anemia in certain rare blood disorders and is also being evaluated for additional indications for hematology therapies.

In connection with this ongoing collaboration, Merck receives a 20% sales royalty from BMS which could increase to a maximum of 24% based on sales levels.

This royalty will be reduced by 50% upon the earlier of patent expiry or generic entry on an indication-by-indication basis in each market.

Additionally, Merck received a contingent regulatory milestone payment of $20 million in 2022 and remains eligible to receive up to $80 million in sales-based milestones.

The transaction was accounted for as a business combination.

critical immune control nodes.

Additionally, Merck announced it will discontinue the development of once-monthly oral islatravir for pre-exposure prophylaxis (PrEP).

In January 2021, Merck entered into an exclusive license and research collaboration agreement with Artiva Biotherapeutics, Inc. (Artiva) to discover, develop and manufacture CAR-NK cells that target certain solid tumors using Artiva’s proprietary platform.

Merck and Artiva agreed to engage in up to three different research programs, each covering a collaboration target.

Merck has sole responsibility for all development and commercialization activities (including regulatory filing and approval).

Under the terms of the agreement, Merck made an upfront payment of $30 million, which was included in *Research and development* expenses in 2021, for license and other rights for the first two collaboration targets and agreed to make another upfront payment of $15 million for license and other rights for the third collaboration target when it is selected by Merck and accepted by Artiva.

In addition, Artiva is eligible to receive future contingent milestone payments (which span all three collaboration targets), aggregating up to $217.5 million in developmental milestones, $570 million in regulatory milestones, and $1.05 billion in sales-based milestones.

The agreement also provides for Merck to pay tiered royalties ranging from 7% to 14% on future sales.

For the fourth quarter of [removed: 2022,] [added: 2023,] 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: 2022.][added: 2023.]

The effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears herein.

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

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

| *Chairman, [removed: President and] Chief Executive [removed: Officer*] [added: Officer and President*] | | | *Executive Vice President and Chief Financial Officer* | | |

Based on this evaluation, management concluded that internal control over financial reporting was effective as of December 31, 2023.

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

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

Insider Trading Arrangements

During the three months ended December 31, 2023, 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.

None.

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

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

Election of Directors of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held May [removed: 23, 2023.][added: 18, 2024.]

Information on executive officers is set forth in Part I of this document on page [removed: [40](#ia384118d157240e09e39541b90e2080f_70).][added: [41](#if867e97bbc5e45a5b3d3d91a8ba0c4c7_67).]

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 May [removed: 23, 2023.][added: 18, 2024.]

The Code of Conduct is available on the Company’s website at [removed: merck.com/company-overview/culture-and-values/code-of-conduct/values-and-standards.][added: www.merck.com/company-overview/culture-and-values/code-of-conduct/values-and-standards/.]

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 May [removed: 23, 2023.][added: 18, 2024.]

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 vs. 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”, 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 May [removed: 23, 2023.][added: 18, 2024.]

The required information on director compensation is incorporated by reference from the discussion under the heading “Director Compensation” and related [removed: “2022] [added: “2023] Schedule of Director Fees” table and [removed: “2022] [added: “2023] Director Compensation” table of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held May [removed: 23, 2023.][added: 18, 2024.]

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 May [removed: 23, 2023.][added: 18, 2024.]

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

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_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 May [removed: 23, 2023.][added: 18, 2024.]

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: 2022.][added: 2023.]

*(2)Excludes approximately [removed: 12,700,042] [added: 12,541,646] shares of restricted stock units and [removed: 1,980,608] [added: 1,966,333] performance share units (assuming maximum payouts) under the Merck Sharp & Dohme 2010 and 2019 Incentive Stock Plans.

Also excludes [removed: 182,601] [added: 157,619] shares of phantom stock deferred under the MSD Employee Deferral Program and [removed: 487,534] [added: 503,549] 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)* | | | | | | 13,526,932*(2)* | | | | | | $ | 77.54 | | | | | 81,123,362 | | |

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

| Equity compensation plans approved by security holders*(1)* | | | | | | 13,719,333*(2)* | | | | | | $ | 70.55 | | | | | 86,776,452 | | |

| Total | | | | | | 13,719,333 | | | | | | $ | 70.55 | | | | | 86,776,452 | | |

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 May [removed: 23, 2023.][added: 18, 2024.]

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 May [removed: 23, 2023.][added: 18, 2024.]

Ratification of Appointment of Independent Registered Public Accounting Firm for [removed: 2023] [added: 2024] 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 May [removed: 23, 2023.][added: 18, 2024.]

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

[Table](#ia384118d157240e09e39541b90e2080f_7) [](#ia384118d157240e09e39541b90e2080f_7)[of](#ia384118d157240e09e39541b90e2080f_7) [Contents](#ia384118d157240e09e39541b90e2080f_7)

Consolidated statement of income for the years ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020][added: 2021]

Consolidated statement of comprehensive [added: (loss)] income for the years ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020][added: 2021]

Consolidated balance sheet as of December 31, [removed: 2022] [added: 2023] and [removed: 2021][added: 2022]

Consolidated statement of equity for the years ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020][added: 2021]

Consolidated statement of cash flows for the years ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020][added: 2021]

| 3.2 | | | | | | — | | | | | | [By-Laws of Merck & Co., Inc. [removed: (effective](https://www.sec.gov/Archives/edgar/data/310158/000031015822000006/exhibit31-byxlawsasamended.htm) [March](https://www.sec.gov/Archives/edgar/data/310158/000031015822000006/exhibit31-byxlawsasamended.htm) [22,](https://www.sec.gov/Archives/edgar/data/310158/000031015822000006/exhibit31-byxlawsasamended.htm) [2022)](https://www.sec.gov/Archives/edgar/data/310158/000031015822000006/exhibit31-byxlawsasamended.htm) [—] [added: (effective March 22, 2022) —] Incorporated by reference to Merck & Co., Inc.’s Current Report on Form 8-K [removed: filed](https://www.sec.gov/Archives/edgar/data/310158/000031015822000006/exhibit31-byxlawsasamended.htm) [March] [added: filed March] 25, [removed: 2022](https://www.sec.gov/Archives/edgar/data/310158/000031015822000006/exhibit31-byxlawsasamended.htm) [(No.] [added: 2022 (No.] 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000031015822000006/exhibit31-byxlawsasamended.htm) | | |

| [removed: *10.7] [added: *10.27] | | | | | | — | | | | | | [Form of stock option terms for [removed: 2017] [added: 2023] annual non-qualified option grants under the Merck & Co., Inc. [removed: 2010] [added: 2019] Incentive Stock Plan - Filed [removed: herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828023005061/exhibit107-2017annualnqsot.htm)] [added: herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1027-2023annualnqsoterms.htm)] | | |

| *10.8 | | | | | | — | | | | | | [Form of stock option terms for 2019 annual non-qualified option grants under the Merck & Co., Inc. 2010 Incentive Stock Plan [removed: - Filed herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828023005061/exhibit108-2019annualnqsot.htm)] [added: -](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm) [Incorporated by re](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm)[ference to Exhibit 10.8 to Merck & Co., Inc.](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm)[’](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm)[s Form 10-K Annual Report for the fiscal year ended December](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm) [31, 202](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm)[2](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm) [filed](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm) [February 2](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm)[4, 2](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm)[023 (No. 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex108-2019annualnqsotermsa.htm)] | | |

| *10.9 | | | | | | — | | | | | | [Form of stock option terms for 2018 quarterly and annual non-qualified option grants under the Merck & Co., Inc. 2010 Incentive Stock Plan — Incorporated by [removed: referen](http://www.sec.gov/Archives/edgar/data/310158/000031015818000005/ex1012_2018nqsogranttermsu.htm)[c](http://www.sec.gov/Archives/edgar/data/310158/000031015818000005/ex1012_2018nqsogranttermsu.htm)e] [added: referenc](http://www.sec.gov/Archives/edgar/data/310158/000031015818000005/ex1012_2018nqsogranttermsu.htm)e] [to Exhibit 10.12 to Merck & Co., Inc.’s Form 10-K Annual Report for the fiscal year ended December 31, 2017 filed February 27, 2018 (No. 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000031015818000005/ex1012_2018nqsogranttermsu.htm) | | |

| *10.11 | | | | | | — | | | | | | [Merck & Co., Inc. 2019 Incentive Stock Plan - Incorporated by reference to Appendix C to Merck & Co., Inc.’s Schedule 14A filed April 8, 2019 (No. 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000114036119006720/mrk-def14a_052819.htm) and [to the Registration Statement on Form S-8 filed August 12, 2019 to register 111,000,000 shares under the 2019 Incentive [removed: Stock](https://www.sec.gov/Archives/edgar/data/310158/000110465919045319/a19-16979_1s8.htm) [Plan] [added: Stock Plan] (File [removed: No.](https://www.sec.gov/Archives/edgar/data/310158/000110465919045319/a19-16979_1s8.htm) [333-233226)](https://www.sec.gov/Archives/edgar/data/310158/000110465919045319/a19-16979_1s8.htm)] [added: No. 333-233226)](https://www.sec.gov/Archives/edgar/data/310158/000110465919045319/a19-16979_1s8.htm)] | | |

| *10.13 | | | | | | — | | | | | | [Merck & Co., Inc. U.S. Separation Benefits Plan (amended and restated as of January 1, 2019) as further amended by Amendments 2019-1 (as of December 19, 2019), 2020-1 (as of February 25, 2020), 2020-2 (as of December 10, 2020), 2021-1 (as of March 31, 2021), 2021-2 (as of December 16, 2021), 2022-1 (as of December 14, 2022) and 2022-2 (as of December 13, 2021) [removed: - Filed herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828023005061/exhibit1013-plansepmrk2019.htm)] [added: -](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm) [Incorporated by reference to Exhibit 10.1](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm)[3 to Merck](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm) [& Co., Inc.](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm)[’](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm)[s](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm) [Form 10-K Annual Report for the fiscal year ended December 31, 202](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm)[2](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm) [filed Fe](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm)[bruary 24, 2023 (No. 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1013-plansepmrk2019.htm)] | | |

| *10.15 | | | | | | — | | | | | | [Merck & Co., Inc. Plan for Deferred Payment of Directors’ Compensation (Amended and Restated effective as of January 1, [removed: 2022)](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1017-planfordeferre.htm) [](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1017-planfordeferre.htm)[\-] [added: 2022) -] Incorporated by reference to Exhibit 10.17 to Merck & Co., [removed: Inc.](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1017-planfordeferre.htm)[’](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1017-planfordeferre.htm)[s] [added: Inc.’s] Form 10-K Annual Report for the fiscal year ended December 31, [removed: 2021](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1017-planfordeferre.htm) [filed](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1017-planfordeferre.htm) [February] [added: 2021 filed February] 25, 2022 (No. 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1017-planfordeferre.htm) | | |

| [removed: 10.16] [added: *10.16] | | | | | | — | | | | | | [removed: [Distribution agreement] [added: [Offer Letter] between [removed: Schering-Plough] [added: Merck & Co., Inc.] and [removed: Centocor, Inc.,] [added: Jennifer Zachary,] dated [removed: April 3, 1998 —] [added: March 16, 2018 -] Incorporated by reference to Exhibit [removed: 10(u)] [added: 10.28] to [removed: Schering-Plough’s Amended] [added: Merck & Co., Inc.’s Form] 10-K [added: Annual Report] for the [added: fiscal] year ended December 31, [removed: 2003] [added: 2018] filed [removed: May 3, 2004] [added: February 27, 2019] (No. [removed: 1-6571)†](http://www.sec.gov/Archives/edgar/data/310158/000095012304005617/y96428exv10wu.txt)] [added: 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000031015819000014/a2018form10-k_ex1028xoffer.htm)] | | |

| [removed: *10.18] [added: *10.30] | | | | | | — | | | | | | [Offer Letter between Merck & Co., Inc. and [removed: Jennifer Zachary,] [added: Chirfi Guindo,] dated [removed: March 16, 2018 - Incorporated] [added: June 8, 2022 -](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1030-mrkchirfiguindooffe.htm) [Incorporated] by reference to Exhibit [removed: 10.28 to] [added: 10](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1030-mrkchirfiguindooffe.htm)[.30](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1030-mrkchirfiguindooffe.htm) [to] Merck & Co., [removed: Inc.’s] [added: Inc.](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1030-mrkchirfiguindooffe.htm)[’](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1030-mrkchirfiguindooffe.htm)[s] Form 10-K Annual Report for the fiscal year ended December 31, [removed: 2018] [added: 2022] filed February [removed: 27, 2019] [added: 24, 2023] (No. [removed: 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000031015819000014/a2018form10-k_ex1028xoffer.htm)] [added: 1](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1030-mrkchirfiguindooffe.htm)[\-6571)](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1030-mrkchirfiguindooffe.htm)] | | |

| [removed: *10.19] [added: *10.17] | | | | | | — | | | | | | [Form of stock option terms for 2021 annual non-qualified option grants under the Merck & Co., Inc. 2019 Incentive Stock Plan [removed: -](http://www.sec.gov/Archives/edgar/data/310158/000031015821000004/ex1023-2021annualnqsoterms.htm) [Incorporated] [added: - Incorporated] by reference to Exhibit 10.23 to Merck & Co., Inc.’s Form 10-K Annual Report for the fiscal year ended December 31, 2020 filed February 25, 2021 (No. 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000031015821000004/ex1023-2021annualnqsoterms.htm) | | |

| [removed: *10.20] [added: *10.18] | | | | | | — | | | | | | [Form of restricted stock unit terms for 2021 annual grants under the Merck & Co., Inc. 2019 Incentive Stock Plan [removed: -](http://www.sec.gov/Archives/edgar/data/310158/000031015821000004/ex10-24x2021annualrsuterms.htm) [Incorporated] [added: - Incorporated] by reference to Exhibit 10.24 to Merck & Co., Inc.’s Form 10-K Annual Report for the fiscal year ended December 31, 2020 filed February 25, 2021 (No. 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000031015821000004/ex10-24x2021annualrsuterms.htm) | | |

| [removed: *10.21] [added: *10.19] | | | | | | — | | | | | | [Form of stock option terms for 2022 annual non-qualified option grants under the Merck & Co., Inc. 2019 Incentive Stock [removed: Plan](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1024-2022annualnqso.htm) [-] [added: Plan -] Incorporated by reference to Exhibit 10.24 to Merck & Co., Inc.’s Form 10-K Annual Report for the fiscal year ended December 31, 2021 filed February 25, 2022 (No. 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1024-2022annualnqso.htm) | | |

| [removed: *10.22] [added: *10.20] | | | | | | — | | | | | | [Form of restricted stock unit terms for 2022 annual grants under the Merck & Co., Inc. 2019 Incentive Stock [removed: Plan](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1025-2022annualrsut.htm) [](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1025-2022annualrsut.htm)[\-] [added: Plan -] Incorporated by reference to Exhibit 10.25 to Merck & Co., [removed: Inc.](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1025-2022annualrsut.htm)[’](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1025-2022annualrsut.htm)[s] [added: Inc.’s] Form 10-K Annual Report for the fiscal year ended December 31, 2021 filed February 25, 2022 (No. 1-6571)](http://www.sec.gov/Archives/edgar/data/310158/000031015822000003/exhibit1025-2022annualrsut.htm) | | |

| [removed: *10.23] [added: *10.29] | | | | | | — | | | | | | [removed: [2019] [added: [2](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1029-2023annualpsutermsa.htm)[0](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1029-2023annualpsutermsa.htm)[23 Performan](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1029-2023annualpsutermsa.htm)[ce Share Unit] terms for [removed: CEO annual non-qualified option] grant under the Merck & Co., Inc. [removed: 2010] [added: 2019] Incentive Stock Plan - Filed [removed: herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828023005061/exhibit1023-2019annualceon.htm)] [added: herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1029-2023annualpsutermsa.htm)] | | |

| *10.24 | | | | | | — | | | | | | [removed: [Form of restricted stock unit terms] [added: [Terms] for [removed: 2019 annual grants] [added: Restricted Stock Unit Grants] under the Merck & Co., Inc. [removed: 2010] [added: 2019] Incentive Stock Plan [removed: - Filed herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828023005061/exhibit1024-2019annualrsut.htm)] [added: -](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1024-2021specialretentio.htm) [Incorporated by reference to Exhibit 10.](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1024-2021specialretentio.htm)[24](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1024-2021specialretentio.htm) [to Merck & Co., Inc.](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1024-2021specialretentio.htm)[’](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1024-2021specialretentio.htm)[s Form 10-K Annual Report for the fiscal year ended December 31, 2022 filed](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1024-2021specialretentio.htm) [F](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1024-2021specialretentio.htm)[ebruary 24, 2023 (No. 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1024-2021specialretentio.htm)] | | |

| [removed: *10.25] [added: *10.21] | | | | | | — | | | | | | [Form of stock option terms for 2020 annual non-qualified option grants under the Merck & Co., Inc. 2019 Incentive Stock Plan [removed: — Filed herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828023005061/exhibit1025-2020annualnqso.htm)] [added: —](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm) [Incorpor](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm)[ated by reference to Exhibit 10.2](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm)[1](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm) [to Merck & Co., Inc](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm)[.](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm)[’](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm)[s Form 10-K Annual](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm) [Report for the fiscal year ended December 31, 202](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm)[2 filed February 24, 2023 (No. 1-6571)](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1021-2020annualnqsoterms.htm)] | | |

| [removed: *10.26] [added: *10.28] | | | | | | — | | | | | | [removed: [2020] [added: [2](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1028-2022annualpsutermsa.htm)[022 Performance Share Unit] terms for [removed: CEO annual non-qualified option] grant [removed: under] [added: un](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1028-2022annualpsutermsa.htm)[der] the Merck & Co., Inc. 2019 Incentive Stock Plan [removed: —] [added: -] Filed [removed: herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828023005061/exhibit1026-2020annualceon.htm)] [added: herewith](https://www.sec.gov/Archives/edgar/data/310158/000162828024006850/ex1028-2022annualpsutermsa.htm)] | | |