What changed in this filing

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Item 1. Business

2025-02-25 compared with 2024-02-26 · 399 added, 408 removed, 545 unchanged (60% of the section changed)

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The Company sells its products to veterinarians, distributors, animal producers, farmers and pet owners.

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

(Organon) through a distribution of Organon’s publicly traded stock to Company shareholders.

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

All product or service marks appearing in type form different from that of the surrounding text are trademarks or service marks owned, licensed to, promoted or distributed by Merck, its subsidiaries or affiliates, except as noted.

All other trademarks or services marks are those of their respective owners.

All other trademarks or service marks are those of their respective owners.

Product Sales

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8,583 8,886 6,897

Januvia/Janumet 3,366 4,513 5,288

ProQuad/M-M-R II /Varivax

2,485 2,368 2,241

Januvia/Janumet 2,268 3,366 4,513

Bridion 1,764 1,842 1,685

Lagevrio 1,428 5,684 952

Alliance revenue - Lynparza (1)

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Alliance revenue - Lenvima (1)

1,010 960 876

Lagevrio 964 1,428 5,684

RotaTeq 711 769 783

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(2) Other revenues are primarily comprised of miscellaneous corporate revenues, including revenue hedging activities, as well as revenue from third-party manufacturing arrangements.

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Pharmaceutical

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Certain of the products within the Company’s franchises are as follows:

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

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

Keytruda is also approved as monotherapy for the adjuvant treatment of certain patients with melanoma, and for certain patients with renal cell carcinoma (RCC) post-surgery.

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Additionally, Keytruda is approved for patients with certain types of resectable NSCLC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

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

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

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.

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

In addition, Keytruda is approved in combination with chemotherapy for the treatment of certain patients with advanced NSCLC, advanced malignant pleural mesothelioma, HNSCC, advanced biliary tract cancer, advanced esophageal cancer, advanced TNBC, and advanced or recurrent endometrial carcinoma;

in combination with chemotherapy with or without bevacizumab, and in combination with chemoradiotherapy, for the treatment of certain patients with advanced cervical cancer;

in combination with trastuzumab and chemotherapy for the treatment of certain patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric or GEJ adenocarcinoma with programmed death-ligand 1 (PD-L1) (CPS ≥1), and in combination with chemotherapy for the treatment of certain patients with advanced HER2-negative gastric or GEJ adenocarcinoma;

in combination with axitinib for the treatment of certain patients with advanced RCC;

in combination with Lenvima (lenvatinib) for the treatment of certain patients with advanced RCC or advanced endometrial carcinoma;

and in combination with enfortumab vedotin for certain patients with locally advanced or metastatic urothelial cancer.

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

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;

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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;

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.

RotaTeq (Rotavirus Vaccine, Live Oral, Pentavalent), a vaccine to help protect against rotavirus gastroenteritis in infants and children;

and Pneumovax 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal disease.

Hospital Acute Care

Bridion (sugammadex), a medication for the reversal of two types of neuromuscular blocking agents used during surgery;

Prevymis (letermovir) for the prophylaxis of cytomegalovirus (CMV) infection and disease, or of CMV disease, in certain high risk adult recipients of an allogeneic hematopoietic stem cell transplant or of a kidney transplant, respectively;

Prevymis (letermovir) for the prophylaxis of cytomegalovirus (CMV) infection and disease, or of CMV disease, in certain high risk adult and pediatric recipients of an allogeneic hematopoietic stem cell transplant or of a kidney transplant, respectively;

Dificid (fidaxomicin) for the treatment of C.

difficile -associated diarrhea;

Zerbaxa (ceftolozane and tazobactam) for injection, a combination antibacterial and beta-lactamase inhibitor for the treatment of certain

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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.

Zerbaxa (ceftolozane and tazobactam) for injection, a combination antibacterial and beta-lactamase inhibitor for the treatment of certain bacterial infections;

and Noxafil (posaconazole), an antifungal agent for the prevention of certain invasive fungal infections.

Cardiovascular

Winrevair (sotatercept-csrk), an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1) to increase exercise capacity,

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improve WHO functional class and reduce the risk of clinical worsening events;

Adempas (riociguat), a cardiovascular drug for the treatment of chronic thromboembolic pulmonary hypertension or pulmonary arterial hypertension in certain patients;

Verquvo (vericiguat), a medicine to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in certain adults with symptomatic chronic heart failure and reduced ejection fraction.

Lagevrio , an investigational oral antiviral COVID-19 medicine available in the U.S.

and Verquvo (vericiguat), a medicine to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in certain adults with symptomatic chronic heart failure and reduced ejection fraction.

Lagevrio (molnupiravir), an investigational oral antiviral COVID-19 medicine available in the U.S.

under Emergency Use Authorization (EUA);

Isentress/Isentress HD (raltegravir), an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection;

Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate), a complete regimen for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history or to replace the current antiretroviral regime in certain patients who are virologically suppressed on a stable antiretroviral regimen;

and Pifeltro (doravirine), a non-nucleoside reverse transcriptase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history or to replace the current antiretroviral regime in certain patients who are virologically suppressed on a stable antiretroviral regimen.

Belsomra (suvorexant), an orexin receptor antagonist, indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Simponi (golimumab), a once-monthly subcutaneous treatment for certain inflammatory diseases;

and Remicade (infliximab), a treatment for inflammatory diseases, both of which the Company markets in Europe, Russia and Türkiye.

Januvia (sitagliptin) and Janumet (sitagliptin/metformin HCl) for the treatment of type 2 diabetes.

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Nuflor (Florfenicol) antibiotic range for use in cattle and swine;

Bovilis / Vista vaccine lines for infectious diseases in cattle;

Bovilis / Vista vaccine lines for infectious diseases in cattle, including Bovilis Cryptium for protection against Cryptosporidium parvum;

Banamine (Flunixin meglumine) bovine and swine anti-inflammatory;

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Exzolt , a systemic treatment for poultry red mite infestations;

Slice (Emamectin benzoate) parasiticide for sea lice in salmon;

Slice (emamectin benzoate) parasiticide and Imvixa (lufenuron) for sea lice control in salmon;

Clynav vaccine for protection against pancreas disease in salmon;

Aquavac (Avirulent Live Culture)/ Norvax vaccines against bacterial and viral disease in fish;

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Companion Animal Products

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;

Bravecto , a line of oral, topical and injectable parasitic control products, including the original Bravecto (fluralaner) products for dogs and cats that last up to 12 weeks;

Bravecto (fluralaner) One-Month , a monthly product for dogs, Bravecto (fluralaner) Injectable/Quantum , an injectable product for dogs that lasts up to one-year, and Bravecto Plus (fluralaner/moxidectin), a two-month product for cats;

Sentinel, a line of oral parasitic products for dogs including Sentinel Spectrum (milbemycin oxime, lufenuron, and praziquantel) and Sentinel Flavor Tabs (milbemycin oxime, lufenuron);

Optimmune (cyclosporine), an ophthalmic ointment;

Nobivac vaccine lines for flexible dog and cat vaccination;

Nobivac vaccine lines for flexible dog and cat vaccination, including Nobivac NXT for canine flu and feline leukemia virus;

GilvetMab , an immune checkpoint inhibitor monoclonal antibody conditionally licensed for melanoma and mastocytoma tumors;

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Regumate (altrenogest) fertility management for horses;

Prestige vaccine line

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Scalibor (Deltamethrin) /Exspot for protecting against bites from fleas, ticks, mosquitoes and sandflies;

Prestige vaccine line for horses;

Scalibor (Deltamethrin) /Exspot for protecting against bites

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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 .

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Product Date Approval

Keytruda January 2023

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.

FDA full approval for the treatment of adult and pediatric patients with unresectable or metastatic MSI-H or dMMR solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

The conversion from an accelerated to a full (regular) approval is based on the KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 trials.

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.

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.

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.

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.

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.

FDA full approval for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

The conversion from an accelerated to a full (regular) approval is based on the KEYNOTE-913 and KEYNOTE-017 trials.

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.

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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.

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.

Food and Drug Administration (FDA) approval in combination with chemoradiotherapy for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer, based on the KEYNOTE-A18 trial.

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.

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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.

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

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.

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.

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.

China’s National Medical Products Administration (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.

European Commission (EC) approval in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for resectable NSCLC at high risk of recurrence in adults, based on the KEYNOTE-671 trial.

Japan’s Ministry of Health, Labor and Welfare (MHLW) approval in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, based on the KEYNOTE-859 trial.

Japan’s MHLW approval in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer, based on the KEYNOTE-966 trial.

FDA approval in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma, based on the KEYNOTE-868 trial.

China’s NMPA approval in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma whose tumors express PD-L1 as determined by a fully validated test, based on the KEYNOTE-811 trial.

September 2024

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.

EC approval in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults, based on the KEYNOTE-A39 trial that was conducted in collaboration with Seagen (now Pfizer Inc.) and Astellas.

September 2024

FDA approval in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, based on the IND.227/KEYNOTE-483 trial.

September 2024

Japan’s MHLW approval in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy as an adjuvant treatment for patients with NSCLC, based on the KEYNOTE-671 trial.

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September 2024

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

September 2024

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

September 2024

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

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

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

November 2024

Japan’s MHLW approval in combination with chemoradiotherapy as treatment for patients with locally advanced cervical cancer, based on the KEYNOTE-A18 trial.

December 2024

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.

Japan’s MHLW approval in combination with carboplatin and paclitaxel as treatment for adult patients with advanced or recurrent endometrial carcinoma, based on the KEYNOTE-868 trial.

December 2024

China’s NMPA approval in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery for patients with resectable stage II, IIIA, or IIIB NSCLC, based on the KEYNOTE-671 trial.

December 2024

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

China’s NMPA approval in combination with Padcev for adult patients with locally advanced or metastatic urothelial cancer, based on the KEYNOTE-A39 trial.

Bravecto January 2024

EC approval of injectable formulation for dogs for the persistent killing of fleas and ticks for 12 months after treatment.

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

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

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

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November 2024

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

February 2025

EC conditional approval as monotherapy both for the treatment of adult patients with VHL disease who require therapy for associated, localized RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, and for whom localized procedures are unsuitable, and for the treatment of adult patients with advanced clear cell RCC that progressed following two or more lines of therapy that included a PD-1 or PD-L1 inhibitor and at least two VEGF targeted therapies.

The EC approval of these two indications is based on results from the LITESPARK-004 and LITESPARK-005 trials.

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

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

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

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Competition and the Health Care Environment

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Changes to the U.S.

health care system as part of health care reform enacted in prior years, as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries, have contributed to pricing pressure.

health care system as part of health care reform, as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries, have contributed to pricing pressure.

In several international markets, government-mandated pricing actions have reduced prices of generic and patented drugs.

In addition, the Company’s sales performance in 2024 was negatively affected by other cost-reduction measures taken by governments and other third parties to lower health care costs.

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

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

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

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In addressing global cost containment pressures, the Company engages in public policy advocacy with policymakers and continues to work to demonstrate that its medicines provide value to patients and to those who pay for health care.

The Company advocates with government policymakers to encourage a long-term approach to sustainable health care financing that ensures access to innovative medicines and does not disproportionately target pharmaceuticals as a source of budget savings.

In markets with historically low rates of health care spending, the Company encourages those governments to increase their investments and adopt market reforms in order to improve their citizens’ access to appropriate health care, including medicines.

Operating conditions have become more challenging under the global pressures of competition, industry regulation and cost containment efforts.

Although no one can predict the effect of these and other factors on the Company’s business, the Company continually takes measures to evaluate, adapt and improve the organization and its business practices to better meet customer needs and believes that it is well-positioned to respond to the evolving health care environment and market forces.

United States

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 (IRA).

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

In the U.S., federal and state governments for many years have pursued methods to reduce the cost of drugs and vaccines for which they pay.

For example, federal and state laws require the Company to pay specified rebates for medicines reimbursed by Medicaid and to provide discounts for medicines purchased by certain state and federal entities such as the Department of Defense, Veterans Affairs, Public Health Service entities and hospitals serving a disproportionate share of low income or uninsured patients.

Additionally in the U.S., consolidation and integration among health care providers is a major factor in the competitive marketplace for pharmaceutical products.

Health plans and pharmacy benefit managers (PBMs) have been consolidating into fewer, larger entities, thus enhancing their purchasing strength and importance.

Additionally in the U.S., consolidation and integration among health care entities is a major factor in the competitive marketplace for pharmaceutical products.

Health plans and pharmacy benefit managers have been consolidating into fewer, larger entities, thus enhancing their purchasing strength and importance.

Private third-party insurers, as well as governments, employ formularies to control costs by negotiating discounted prices in exchange for formulary inclusion.

Failure to obtain timely or adequate pricing or formulary placement for Merck’s products or obtaining such placement at unfavorable pricing could adversely affect revenue.

In addition to formulary

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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.

Private health insurance companies also are increasingly imposing utilization management tools, such as clinical protocols, requiring prior authorization for a branded product or requiring the patient to first fail on one or more generic products before permitting access to a branded medicine.

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.

Private health insurance companies, as well as governments, also are increasingly imposing utilization management tools, such as clinical protocols, requiring prior authorization for a branded product or requiring the patient to first fail on one or more generic products before permitting access to a branded medicine.

These same management tools are also used in treatment areas in which the payor has taken the position that multiple branded products are therapeutically comparable.

payor market concentrates further, the Company may face greater pricing pressure from private third-party payors.

In order to provide information about the Company’s pricing practices, the Company annually posts on its website its Pricing Transparency Report for the U.S.

The report provides the Company’s average annual list price, net price increases, and average discounts across the Company’s U.S.

portfolio dating back to 2010.

In 2023, the Company’s gross U.S.

sales were reduced by 37% as a result of rebates, discounts and returns.

Legislative Changes

In 2022, Congress passed the 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.

In 2022, Congress passed the 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, which has taken effect in 2025, and government price setting for certain Medicare Part D drugs, starting in 2026, and Medicare Part B drugs starting in 2028.

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

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.

Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), selected Januvia for the first year of the IRA’s “Drug Price Negotiation Program” (Program).

Pursuant to the IRA’s Program, a government price was set for Januvia , which will become effective on January 1, 2026.

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

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

sales of Keytruda will decline after that time.

The Company has sued the U.S.

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“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.

The long-term implications of the IRA remain uncertain and subject to various factors, including the manner in which the U.S.

Department of Health and Human Services decides to implement the statute.

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the Executive Branch and Congress continue to discuss legislation designed to control health care costs, including the cost of drugs.

The long-term implications of the IRA remain uncertain and subject to various factors, including the manner in which HHS decides to implement the statute.

Many experts and analysts, both within the industry and outside, have predicted that the law will harm innovation in the pharmaceutical industry and result in fewer new treatments being developed and approved over time.

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Prior to this change, manufacturers have not been required to pay more than 100% of the Average Manufacturer Price (AMP) in rebates to state Medicaid programs for Medicaid-covered drugs.

As a result of this provision, beginning in 2024, manufacturers may have to pay state Medicaid programs more in rebates than they received on sales of particular products.

As a result of this provision, manufacturers may have to pay state Medicaid programs more in rebates than they received on sales of particular products.

This change presents a risk to Merck for drugs that have high Medicaid utilization and rebate exposure that is more than 100% of the AMP.

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Some laws also require manufacturers to provide advance notification of price increases.

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

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

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In addition, in 2024, the FDA authorized, for a two-year period, Florida’s application to import prescription drugs from Canada.

Regulatory Changes

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The authorities then use the price data to set new local prices for brand-name drugs, including the Company’s drugs.

Guidelines for examining reference pricing are usually set in local markets and can be changed pursuant to local regulations.

Reference pricing mechanisms are usually set at the national level and can be changed pursuant to local regulations or guidance.

Some EU Member States have established free-pricing systems, but regulate the pricing for drugs through profit control plans.

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The HTA of pharmaceutical products is becoming an increasingly common part of the pricing and reimbursement procedures in most EU Member States.

The HTA process, which is governed by the national laws of these countries, involves the assessment of the cost-effectiveness, public health impact, therapeutic impact and/or the economic and social impact of use of a given pharmaceutical product in the national health care system of the individual country in which it is conducted.

The HTA process, which is currently governed by the national laws of these countries, involves the assessment of the cost-effectiveness, public health impact, therapeutic impact and/or the economic and social impact of use of a given pharmaceutical product in the national health care system of the individual country in

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which it is conducted.

Ultimately, an HTA measures the added value of a new health technology compared to existing ones.

The outcome of HTAs regarding specific pharmaceutical products will often influence the pricing and reimbursement status granted to these pharmaceutical products by the regulatory authorities of individual EU Member States.

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

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

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

The HTAR applies to all new active substance oncology products and advanced therapy medicinal products, including cell and gene therapies, beginning January 1, 2025;

to new active substance orphan medicinal products beginning January 1, 2028;

and to all products approved via the centralized procedure beginning in 2030.

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

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

The outcome of HTAs regarding specific pharmaceutical products will increasingly influence the pricing and reimbursement status granted to these pharmaceutical products by the market access authorities of individual EU Member States.

A negative HTA of one of the Company’s products may mean that the product is not reimbursable or may force the Company to reduce its reimbursement price or offer discounts or rebates.

A negative HTA by a leading and recognized HTA body could also undermine the Company’s ability to obtain reimbursement for the relevant product outside a jurisdiction.

For example, EU Member States that have not yet developed HTA mechanisms may rely to some extent on the HTA performed in other countries with a developed HTA framework, to inform their pricing and reimbursement decisions.

For example, EU Member States that have not yet developed HTA mechanisms may rely to some extent on JCAs under the HTAR or an HTA performed in other countries with a developed HTA framework, to inform their pricing and reimbursement decisions.

HTA procedures require additional data, reviews and administrative processes, all of which increase the complexity, timing and costs of obtaining product reimbursement and exert downward pressure on available reimbursement.

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In addition, if a Merck product has the same medical action or composition of another product that is subject to market expansion re-pricing, the Merck product could also be subject to re-pricing unless it meets exception criteria.

The next government-mandated price reduction will occur in April 2024.

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

The next government-mandated price reduction is scheduled to occur in April 2025.

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

Continued growth of the Company’s business in China is dependent upon ongoing development of a favorable environment for innovative pharmaceutical products and vaccines, sustained access for the Company’s currently marketed products, and the absence of trade impediments or adverse pricing controls.

In recent years, the Chinese government has introduced and implemented a number of structural reforms to accelerate the shift to innovative products and reduce costs.

Since 2017, there have been multiple new policies introduced by the government to improve access to new innovation, reduce the complexity of regulatory filings, and accelerate the review and approval process.

There have been multiple new policies introduced by the government to improve access to new innovation, reduce the complexity of regulatory filings, and accelerate the review and approval process.

This has led to a significant increase in the number of new products being approved each year.

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The Company expects VBP to be a semi-annual process that will have a significant impact on mature products moving forward.

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Emerging Markets

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Further, the Company may engage third-party agents to assist in operating in emerging market countries, which may affect its ability to realize continued growth and may also increase the Company’s risk exposure.

Operating conditions have become more challenging under the global pressures of competition, industry regulation and cost containment efforts.

The pharmaceutical industry is also subject to regulation by regional, country, state and local agencies around the world focused on standards and processes for determining drug safety and effectiveness, as well as conditions for sale or reimbursement.

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In some cases, the FDA requirements and practices have increased the amount of time and resources necessary to develop new products and bring them to market in the U.S.

At the same time, the FDA has committed to expediting the development and review of products bearing the “breakthrough therapy” designation, which has accelerated the

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regulatory review process for medicines with this designation.

At the same time, the FDA has committed to expediting the development and review of products bearing the “breakthrough therapy” designation, which has accelerated the regulatory review process for medicines with this designation.

The FDA has also undertaken efforts to bring generic competition to market more efficiently and in a more timely manner.

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As a global health care company, Merck’s primary role is to discover and develop innovative medicines and vaccines.

The Company also recognizes that, in collaboration with key stakeholders, it has a role to play in helping to ensure that its science advances health care, and its products are accessible and affordable.

The Company is committed to ensuring a reliable, safe global supply of its quality medicines and vaccines, and to developing, testing and implementing innovative solutions that address barriers to access and affordability of its medicines and vaccines.

The Company’s approach is designed to enable it to serve the greatest number of patients today, while meeting the needs of patients in the future.

The Company is committed to ensuring a high-quality, safe, reliable, supply of its medicines and vaccines, and to implementing innovative solutions that address barriers to sustainable access to its products.

Merck’s approach is designed to enable it to serve the greatest number of patients today, while meeting the needs of patients in the future.

The Company's wide-ranging efforts to expand access to health encompass a set of principles embedded in its business strategies and operations.

These principles guide the Company's global approach to addressing significant public health burdens and unmet medical needs.

The Company systematically evaluates its pipeline candidates to assess their potential in low-resource settings.

Throughout the life cycle of its products, the Company seeks to continually evaluate their potential and adapt to changes in the external environment.

Collaborating with various stakeholders, including private, governmental, multilateral, and non-profit organizations, the Company seeks to design and deliver sustainable solutions to address access challenges at the payer, provider, and patient levels.

These principles guide its global approach to addressing significant public health burdens and unmet medical needs.

The Company systematically evaluates its pipeline candidates to assess their potential in low and middle-income countries and underserved health care settings.

Throughout the life cycle of its products, Merck seeks to evaluate their potential and adapt to changes in the external environment.

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and patient levels.

Furthermore, the Company incorporates access to health metrics in its scorecard, making it a component of calculating annual incentive pay for the majority of its global employees.

In addition, through social investments, including philanthropic programs and impact investing, Merck is helping to strengthen health systems and build capacity, particularly in under-resourced communities.

The Merck Patient Assistance Program provides certain medicines and adult vaccines for free to people in the U.S.

who do not have prescription drug or health insurance coverage and who, without the Company’s assistance, cannot afford their Merck medicines and vaccines.

territories who do not have prescription drug or health insurance coverage and who, without the Company’s assistance, cannot afford their Merck medicines and vaccines.

Globally, Merck has made substantial contributions to access to health through key initiatives, including product donations for humanitarian assistance in low-income countries through the Medical Outreach Program.

The Mectizan Donation Program, the longest running disease-specific drug donation program of its kind, supports the elimination of two neglected tropical diseases – onchocerciasis and lymphatic filariasis.

Additionally, through Merck for Mothers, the Company provides funding, and scientific and business acumen to help global health partners end preventable deaths from complications of pregnancy and childbirth.

Merck has also provided funds to the Merck Foundation, an independent grantmaking organization, which supports a variety of organizations dedicated to addressing systemic barriers to health equity.

Additionally, through Merck for Mothers, the Company provides funding, and scientific and business acumen to help global health partners strengthen health systems, expand access to critical maternal health services, and end preventable deaths from complications of pregnancy and childbirth.

Merck also supports the Merck Foundation, an independent grantmaking organization helping to address systemic barriers to access to health care.

Privacy and Data Protection

The Company is subject to a significant number of privacy and data protection laws and regulations globally, many of which place restrictions on the Company’s ability to transfer, access and use personal data across its business.

The Company is subject to a significant number of privacy and data protection laws and regulations globally, many of which place restrictions on the Company’s ability to collect, transfer, access and use personal data across its business.

The legislative and regulatory landscape for privacy and data protection continues to evolve.

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The GDPR increased responsibility and liability in relation to personal data that the Company processes.

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

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ability to process (which includes collection, analysis and transfer of) personal data, including health data from clinical trials and adverse event reporting.

It also imposes a number of strict obligations and restrictions on the ability to process (which includes collection, analysis and transfer of) personal data, including health data from clinical trials and adverse event reporting.

The GDPR also includes requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals prior to processing their personal data or personal health data, notification of data processing obligations to the national data protection authorities, and the security and confidentiality of the personal data.

Further, the GDPR prohibits the transfer of personal data to countries outside of the EU that are not considered by the EC to provide an adequate level of data protection, including to the U.S., except if the data controller meets very specific requirements.

Following the Schrems II decision of the Court of Justice of the EU in 2020, there is considerable uncertainty as to the permissibility of international data transfers under the GDPR.

Following the Schrems II decision of the Court of Justice of the EU in 2020, uncertainty has existed as to the permissibility of international data transfers under the GDPR.

In light of the implications of this decision, the Company may face difficulties regarding the transfer of personal data from the EU to third countries.

Since then, the Company entered into the EU-approved Standard Contractual Clauses with its vendors, suppliers, collaboration partners and clinical trial sites in order to facilitate the lawful transfer of personal data from the EU to the U.S.

In addition, President Biden issued Executive Order 14086 on October 7, 2022 to address the data privacy concerns raised in the Schrems II decision through introducing, among other measures, further safeguards and oversight of personal data collection by U.S.

In addition, former President Biden issued Executive Order 14086 in October 2022 to address the data privacy concerns raised in the Schrems II decision through introducing, among other measures, further safeguards and oversight of personal data collection by U.S.

signals intelligence activities and providing individuals with a redress mechanism in the U.S.

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Data Privacy Framework (successor to the invalidated EU-U.S.

Privacy Shield) came about by way of a new EU Adequacy Decision, issued by the EC on July 10, 2023.

Privacy Shield) came about by way of a new EU Adequacy Decision, issued by the EC in July 2023.

However, the new Adequacy Decision has already been contested by privacy advocates and is subject to legal review.

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Failing to comply with these obligations could lead to government enforcement actions and significant penalties against the Company, harm to its reputation, and adversely impact its business and operating results.

The uncertainty regarding the interplay between different regulatory frameworks further adds to the complexity that the Company faces with regard to data protection regulation.

In August 2021, China passed the Personal Information Protection Law (PIPL) that aims to standardize the handling of personal information in China which became effective in November 2021.

The uncertainty regarding the interplay between

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different regulatory frameworks further adds to the complexity that the Company faces with regard to data protection regulation.

In 2021, China passed the Personal Information Protection Law (PIPL) that aims to standardize the handling of personal information in China.

The PIPL currently applies to the processing of personal information of natural persons in China, the processing of personal information outside China where the purpose is to provide products and services in China, and to analyze the activities of individuals in China.

While similar to the GDPR, the PIPL contains unique requirements not found in the GDPR.

The Company has developed and implemented comprehensive plans to ensure compliance with the PIPL, with plans relating to data localization and cross-border transfers pending forthcoming guidance from the Cyberspace Administration of China.

Additional laws and regulations enacted in certain states in the U.S., Canada, Europe, Asia, and Latin America, have increased enforcement and litigation activity in the U.S.

The Company has developed and implemented comprehensive plans to ensure compliance with the PIPL, including plans relating to data localization and cross-border transfers.

Additional laws and regulations enacted in Canada, Europe, Asia, Latin America, the Middle East and 19 states in the U.S.

have increased enforcement and litigation activity in the U.S.

and other developed markets, as well as increased regulatory cooperation among privacy authorities globally.

The Company has adopted a comprehensive global privacy program to manage these evolving requirements and risks and to facilitate the transfer of personal information across international borders.

The Company sells its human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers, such as health maintenance organizations, PBMs and other institutions.

Human health vaccines are sold primarily to physicians, wholesalers, distributors and government entities.

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The Company sells its animal health products to veterinarians, distributors, animal producers, farmers and pet owners.

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Raw Materials

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and in most major foreign markets.

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

Patent protection for individual products extends for varying periods in accordance with the legal life of patents in the various countries.

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

Patent protection for individual products extends for varying periods in accordance with the legal life of patents in individual countries.

The protection afforded, which may also vary from country to country, depends upon the type of patent and its scope of coverage.

Patent portfolios developed for products introduced by the Company normally provide market exclusivity.

Key patents may be subject to a patent term restoration (also known as patent term extension or PTE) of up to five years in the U.S., Japan, and certain other jurisdictions, or in Europe, up to five years of extended term may be available in the form of a Supplementary Protection Certificate (SPC).

Patent portfolios developed for products introduced by the Company normally provide varying degrees of market exclusivity.

Key patents, which generally cover the product per se , may be subject to a patent term restoration (also known as patent term extension or PTE) of up to five years in the U.S., Japan, and certain other jurisdictions.

In Europe, up to five years of extended term may be available in the form of a Supplementary Protection Certificate (SPC).

PTEs and SPCs are awarded to offset a portion of the patent term lost during the clinical testing and regulatory review process of a product prior to approval.

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for indications of new or currently marketed drugs if certain agreed upon pediatric studies are completed by the applicant.

The EU also provides an additional six months of pediatric market exclusivity attached to a product’s SPC term.

The EU also provides an additional six months of pediatric market exclusivity attached to a product’s SPC term for both small molecule and biologic products.

Japan attaches the additional term for pediatric studies to market exclusivity and this extension is unrelated to patent term.

Regulatory data exclusivity tied to the protection of clinical data is complementary to patent protection and, in some cases, may provide more effective or longer lasting marketing exclusivity than a product’s patent portfolio.

In the U.S., the regulatory data protection term generally runs five years from first marketing approval of a new chemical entity, extended to seven years for an orphan drug indication, and twelve years from first marketing approval of a biological product.

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In some countries, one or more regulatory exclusivities, including data exclusivity, may provide parallel market protection that is complementary to patent protection and, in some cases, may provide more effective or longer lasting marketing exclusivity than a product’s patent portfolio.

In the U.S., the regulatory data/marketing protection term generally runs five years from first marketing approval of a new chemical entity, extended to seven years for an orphan drug indication, and twelve years from first marketing approval of a biological product.

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The table below provides a list of expiration dates, which include any pending PTE and SPC periods where indicated, for the key patent protection in the U.S., the EU, Japan and China for the following marketed products:

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Expired N/A Expired

Janumet XR 2026 (3)

N/A N/A Expired

Isentress 2024 (4)

Simponi N/A (6)

Bridion 2026 (9)

Bravecto 2026 (with pending PTE) 2029

Isentress Expired (4)

Bravecto 2027

Gardasil 2028 Expired Expired Expired

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Keytruda 2028 (8)

Lynparza (10)

2027 (9) (with pending PTE)

2031 2032-2033 2028

Zerbaxa 2028 (9)

2027 (7) (with pending PTE)

2028-2029 Expired

2027-2028 Expired

Belsomra 2029 N/A 2031 N/A

Prevymis 2029 (9) (with pending PTE)

Prevymis 2029

No Patent (15)

Delstrigo 2032 (with pending PTE) 2033 (9)

Pifeltro 2032 (with pending PTE) 2033 (9)

Welireg 2035 (with pending PTE) N/A N/A N/A

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(5) Expiry date reflects granted PTE for the 600 mg tablet in Japan.

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

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

(6) Part of a global strategic oncology collaboration with Eisai Co., Ltd.

(7) Eligible for six months pediatric market exclusivity.

(8) The compound patent family contains two additional patents that expire in 2029 due to patent term adjustment resulting from patent office delay.

These patents are based on the initial discovery of the active ingredient in Keytruda .

While these patents may provide additional protection, the Company expects that they will be the subject of litigation in the future.

(9) Part of a global strategic oncology collaboration with AstraZeneca.

(10) Eligible for 12 years of data exclusivity in the U.S.

and 10 years in the EU, which will expire in 2036 and 2034, respectively.

Granted patents covering methods of treating pulmonary arterial hypertension with Winrevair , which will expire in 2037 (absent PTE or SPC), may provide additional exclusivity.

(11) Commercialized under a worldwide collaboration with Bayer AG.

(12) The Company has no marketing rights in the U.S.

(13) Data exclusivity has also been granted in the EU and expires in January 2028;

eligible for two additional years of market exclusivity based on pediatric studies for an orphan product.

(14) PTE pending but is not included in the listed patent expiry date.

Data exclusivity has been granted in the U.S.

and expires July 16, 2033.

(14) Data exclusivity has been granted in the EU and Japan, and expires on December 13, 2031 and September 25, 2030, respectively.

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and expires in July 2033.

(15) Data exclusivity has been granted in the EU and Japan, and expires in December 2031 and September 2030, respectively.

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The Company has the following key U.S.

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Year of Expiration (in the U.S.)

MK-7264 (gefapixant) (1)

MK-7962 (sotatercept)

MK-1022 (patritumab deruxtecan) (1)

V116 (pneumococcal vaccine)

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

(2) As a biologic product, MK-7962 (sotatercept) will be eligible for 12 years of data exclusivity upon approval in the U.S.

Granted patents covering methods of treating pulmonary arterial hypertension with MK-7962 (sotatercept), which will expire in 2037 (absent PTE), may also provide additional exclusivity.

MK-1654 (clesrovimab)

(1) Being developed in a collaboration with Daiichi Sankyo.

The FDA issued a Complete Response Letter for the application in June 2024.

The Company also has the following key U.S.

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Year of Expiration (in the U.S.)

MK-8591A (doravirine + islatravir) 2032 (with pending PTE for doravirine patent)

MK-8591A (doravirine + islatravir) (1)

MK-2400 (ifinatamab deruxtecan) (2)

MK-1308A (quavonlimab + pembrolizumab)

MK-1026 (nemtabrutinib)

MK-7684A (vibostolimab + pembrolizumab)

MK-4280A (favezelimab + pembrolizumab)

MK-1654 (clesrovimab)

MK-3543 (bomedemstat)

MK-5684 (opevesostat)

MK-8591D (islatravir + lenacapavir) (1)(2)

2037 (with pending PTE for lenacapavir patent)

MK-2140 (zilovertamab vedotin)

MK-4482 Lagevrio (2)(3)

MK-2870 (sacituzumab tirumotecan) (2)

MK-3475A (pembrolizumab + hyaluronidase subcutaneous) 2039

MK-0616 (enlicitide decanoate)

MK-7240 (tulisokibart)

(1) On partial clinical hold for higher doses of islatravir than those used in current clinical trials.

(2) Being developed in a collaboration.

(2) Received Emergency Use Authorization from the FDA for the treatment of high-risk adults with mild to moderate COVID-19.

Unless otherwise noted, the patents in the above tables are compound patents.

(3) Available in the U.S.

under Emergency Use Authorization.

(4) Program is in a Phase 2/3 study.

Unless otherwise noted, the patents in the above tables cover the product per se (also known as compound patents).

For those drug candidates under review or in development, the key U.S.

patents may be subject to a future PTE of up to five years and/or six month pediatric market exclusivity.

patents may be subject to a future PTE of up to five years and/or six months of pediatric market exclusivity.

In addition, depending on the circumstances surrounding any final regulatory approval of the product, there may be other granted patents or pending patent applications that could have relevance to the product as finally approved.

While the expiration of a compound patent generally results in a loss of market exclusivity for the covered pharmaceutical product, commercial benefits may continue to be derived from:

(i) later-expiring patents on processes and intermediates related to the most economical method of manufacture of the active ingredient of such product;

(ii) patents relating to the use of such product;

(iii) patents relating to novel compositions and formulations;

and (iv) in the U.S.

and certain other countries, market exclusivity that may be available under relevant law.

The effect of product patent expiration on pharmaceutical product sales may also depend upon many other factors such as the nature of the market and the position of the product in it, the growth of the market, the complexities and economics of the process for manufacture of the active ingredient of the product and the requirements of new drug provisions of the Federal Food, Drug and Cosmetic Act or similar laws and regulations in other countries.

Additions to market exclusivity are sought in the U.S.

and other countries through all relevant laws, including laws increasing patent life.

Some of the benefits of increases in patent life have been partially offset by an increase in the number of incentives for and use of generic products.

Additionally, improvements in intellectual property laws are sought in the U.S.

and other countries through reform of patent and other relevant laws and implementation of international treaties.

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While the expiration of the compound patent generally results in loss of market exclusivity for the covered pharmaceutical product, other patents may provide additional market exclusivity associated with certain aspects of the product that extends beyond the compound patent expiration, including those derived from the initial discovery of the product’s active ingredient(s) or from product-related innovation that occurs after this initial discovery.

These include later-expiring patents directed to (i) processes and intermediates related to methods of manufacture of the active ingredient(s), (ii) use(s) of the product, and (iii) novel compositions and formulations of the product.

The effect of product patent expiration on pharmaceutical product sales may also depend upon many other factors such as the nature of the market and the position of the product in it, the growth of the market, the complexities and economics of the process for manufacture of the active ingredient(s) of the product and the requirements of new drug provisions of the Federal Food, Drug and Cosmetic Act or similar laws and regulations in other countries.

In addition, in the U.S.

and certain other countries, a variety of different regulatory exclusivities that impact market exclusivity may be available under relevant law.

For further information with respect to the Company’s patents, see Item 1A.

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“Contingencies and Environmental Liabilities” below.

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Worldwide, all of the Company’s important products are sold under trademarks that are considered in the aggregate to be of material importance.

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Registration is for fixed terms and can be renewed indefinitely.

Royalty income in 2023 on patent and know-how licenses and other rights amounted to $723 million.

Royalty income in 2024 on patent and know-how licenses and other rights amounted to $1.1 billion.

Merck also incurred royalty expenses amounting to $1.9 billion in 2024 under patent and know-how licenses it holds.

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The Company is committed to ensuring that externally sourced programs remain an important component of its pipeline strategy, with a focus on supplementing its internal research through acquisitions as well as a licensing and external alliance strategy focused on the entire spectrum of collaborations from early research to late-stage compounds, as well as access to new technologies.

The Company’s clinical pipeline includes candidates in multiple disease areas, including cancer, cardiovascular diseases, metabolic diseases, infectious diseases, neurosciences, immunology, respiratory diseases, and vaccines.

In the development of human health products, industry practice and government regulations in the U.S.

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Pre-marketing vaccine clinical trials are typically done in three phases.

Initial Phase 1 clinical studies are conducted in normal subjects to evaluate

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the safety, tolerability and immunogenicity of the vaccine candidate.

Initial Phase 1 clinical studies are conducted in normal subjects to evaluate the safety, tolerability and immunogenicity of the vaccine candidate.

Phase 2 studies are dose-ranging studies and provide additional data on safety, immunogenicity and/or effectiveness.

Finally, Phase 3 trials are conducted in the intended population for licensure and provide data on immunogenicity and/or effectiveness, as well as safety, to support applications for regulatory approvals.

Finally, Phase 3 trials are conducted in the

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intended population for licensure and provide data on immunogenicity and/or effectiveness, as well as safety, to support applications for regulatory approvals.

If successful, the Company submits regulatory filings with the appropriate regulatory agencies.

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While in effect, this declaration (as amended) enables the FDA to issue Emergency Use Authorizations (EUAs) permitting distribution and use of specific medical products absent NDA/BLA submission or approval, including products to treat or prevent diseases or conditions caused by the SARS-CoV-2 virus, subject to the terms of any such EUAs.

The Company is currently marketing Lagevrio in the U.S.

pursuant to an EUA.

The FDA must make certain findings to grant an EUA, including that it is reasonable to believe based on the totality of evidence that the drug or biologic may be effective, and that known or potential benefits when used under the terms of the EUA outweigh known or potential risks.

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European Union

The primary method the Company uses to obtain marketing authorization of pharmaceutical products in the EU is through the “centralized procedure.” This procedure is compulsory for certain pharmaceutical products, in particular those using biotechnological processes, and is also available for certain new chemical compounds and

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A company seeking to market an innovative pharmaceutical product through the centralized procedure must file a complete set of safety data and efficacy data as part of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).

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European Medicines Agency (EMA).

After the EMA evaluates the MAA, it provides a recommendation to the EC and the EC then approves or denies the MAA.

It is also possible for new chemical products to obtain marketing authorization in the EU through a “mutual recognition procedure” in which an application is made to a single member state and, if the member state approves the pharmaceutical product under a national procedure, the applicant may submit that approval to the mutual recognition procedure of some or all other EU Member States.

In Japan, the Company submits new drug applications to the PMDA for its pharmaceutical regulatory review.

The PMDA is an independent administrative agency which is under the jurisdiction of the Ministry of Health, Labor and Welfare (MHLW).

The PMDA considers multiple factors in its review process, including the drug’s safety, efficacy, quality, and manufacturing process in accordance with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

In addition, there are various other regulations and guidelines issued by the MHLW or the PMDA that must also be complied with in order to secure approval.

The length of the PMDA review process can vary, but it typically takes around one year for a new drug to be approved in Japan.

The review period may be shortened if the drug candidate is designated by the MHLW as an innovative drug satisfying certain conditions.

In China, the Company submits marketing applications to the NMPA for an independent review.

The NMPA considers multiple factors in its review process, including the drug‘s safety, efficacy, quality, and manufacturing process.

Moreover, the NMPA implements strict regulations to ensure that all drugs meet the same standards as those set by the WHO.

The agency establishes stringent safety and efficacy requirements for drug approval.

The length of the NMPA review process can vary, but it typically takes around one to two years for a new drug to be approved in China.

Other Markets

Outside of the U.S.

and the EU, the Company submits marketing applications to national regulatory authorities.

Examples of such are the Ministry of Health, Labour and Welfare in Japan, the National Medical Products Administration in China, Health Canada, Agência Nacional de Vigilância Sanatária in Brazil, Korea Food and Drug Administration in South Korea, and the Therapeutic Goods Administration in Australia.

Outside of the U.S., the EU, Japan and China, the Company submits marketing applications to national regulatory authorities.

Examples of such are Health Canada, Agência Nacional de Vigilância Sanatária in Brazil, Korea Food and Drug Administration in South Korea, and the Therapeutic Goods Administration in Australia.

Each country has a separate and independent review process and timeline.

4 unchanged sentences

and internationally or in late-stage clinical development.

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

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

The BLA is based on the primary results from the HERTHENA-Lung01 pivotal Phase 2 trial and data results presented at the IASLC 2023 World Conference on Lung Cancer, which were simultaneously published in the Journal of Clinical Oncology.

The FDA set a PDUFA date of June 26, 2024 for the BLA.

The priority review follows receipt of Breakthrough Therapy designation granted by the FDA in December 2021.

The BLA is being reviewed under the Real-Time Oncology Review program.

In June 2024, the FDA issued a CRL for the BLA due to findings pertaining to an inspection of a third-party manufacturing facility.

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

Patritumab deruxtecan (HER3-DXd) was discovered by Daiichi Sankyo and is being jointly developed by Daiichi Sankyo and Merck.

MK-7962, sotatercept, Merck’s novel investigational activin signaling inhibitor, is under priority review by the FDA for the treatment of adult patients with pulmonary arterial hypertension (World Health Organization Group 1).

The application is based on the results from the Phase 3 STELLAR trial.

The FDA set a PDUFA date of March 26, 2024.

Sotatercept is also under review by the EMA.

Sotatercept was granted Breakthrough Therapy designation and Orphan Drug designation by the FDA, as well as Priority Medicines (PRIME) scheme and Orphan Drug designation by the EMA for the treatment of pulmonary arterial hypertension.

Sotatercept is the subject of a licensing agreement with Bristol-Myers Squibb Company (BMS).

V116, the Company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults, is under priority review by the FDA.

The BLA for V116 is supported by results from multiple Phase 3 clinical studies evaluating V116 in both vaccine-naïve and vaccine-experienced adult patient populations, including STRIDE-3, STRIDE-4, STRIDE-5 and STRIDE-6.

The FDA set a PDUFA date of June 17, 2024.

V116 was granted Breakthrough Therapy designation from the FDA for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older.

MK-7264, gefapixant, is a non-narcotic, oral selective P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough in adults.

In December 2023, the FDA issued a second CRL regarding the resubmission of Merck’s NDA for gefapixant.

In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough.

The CRL was not related to the safety of gefapixant.

Merck is reviewing the FDA’s feedback to determine next steps.

Merck is working with Daiichi Sankyo to address FDA feedback.

MK-6482, Welireg, is under review in Japan both for the treatment of adults with VHL disease based on the LITESPARK-004 clinical trial and for the treatment of certain adults with previously treated advanced RCC based on the LITESPARK-005 clinical trial.

Additionally, in January 2025, the FDA accepted for priority review a supplemental NDA seeking approval of Welireg for the treatment of adult and pediatric patients (12 years and older) with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma, based on the LITESPARK-015 trial.

The FDA set a PDUFA, or target action, date of May 26, 2025.

V116, Capvaxive , a 21-valent pneumococcal conjugate vaccine designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia caused by certain serotypes in adults, is under review in the EU and Japan.

The applications are supported by results from multiple Phase 3 clinical studies evaluating V116 in both vaccine-naïve and vaccine-experienced adult patient populations.

In January 2025, the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the approval of Capvaxive for active immunization for the prevention of invasive disease and pneumonia caused by certain types of Streptococcus pneumoniae in individuals 18 years of age and older.

The CHMP’s recommendation will now be reviewed by the EC for marketing authorization in the EU, and a final decision is expected by the second quarter of 2025.

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MK-7962, Winrevair , Merck’s novel activin signaling inhibitor, is under review in Japan for the treatment of adult patients with PAH based on the Phase 3 STELLAR trial.

In November 2024, Merck announced positive topline results from the Phase 3 ZENITH study, evaluating Winrevair in adults with PAH with WHO Group 1 FC III or IV at high risk of mortality.

Based on the positive results of an interim analysis, an independent data monitoring committee recommended that the study be stopped early due to overwhelming efficacy.

In addition, in January 2025, Merck announced the Phase 3 HYPERION study evaluating Winrevair in newly diagnosed adults with PAH FC II or III at intermediate or high risk of disease progression was also stopped early based on the positive results from the interim analysis of the ZENITH trial and a review of the totality of data from the Winrevair clinical program to date.

All participants in both the ZENITH and HYPERION studies will be offered the opportunity to receive Winrevair as part of the open-label, long-term extension study, SOTERIA.

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

In December 2024, the FDA accepted the BLA for clesrovimab and set a PDUFA date of June 10, 2025.

Clesrovimab is also under review in the EU.

MK-3475, Keytruda , is an anti-PD-1 therapy approved for the treatment of many cancers that is in clinical development for expanded indications.

These studies encompass more than 30 cancer types including:

biliary, estrogen receptor positive breast cancer, cervical, colorectal, cutaneous squamous cell, endometrial, esophageal, gastric, glioblastoma, head and neck, hepatocellular, Hodgkin lymphoma, non-Hodgkin lymphoma, non-small-cell lung, small-cell lung, melanoma, mesothelioma, ovarian, prostate, renal, triple-negative breast, and urothelial, many of which are currently in Phase 3 clinical development.

biliary, estrogen receptor positive breast, triple-negative breast, cervical, colorectal, endometrial, esophageal, gastric, glioblastoma, head and neck, hepatocellular, Hodgkin lymphoma, non-Hodgkin lymphoma, non-small-cell lung, small-cell lung, melanoma, malignant pleural mesothelioma, ovarian, prostate, renal, and urothelial, several of which are currently in Phase 3 clinical development.

Further trials are being planned for other cancers.

Keytruda is under priority review by the FDA in combination with standard of care chemotherapy (carboplatin and paclitaxel), followed by Keytruda as a single agent for the treatment of patients with primary

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advanced or recurrent endometrial carcinoma, based on the KEYNOTE-868 trial.

The FDA set a PDUFA date of June 21, 2024 for the supplemental BLA.

Keytruda is under review in the EU and Japan as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB NSCLC based on the KEYNOTE-671 study.

A perioperative treatment regimen includes treatment before surgery (neoadjuvant) and continued after surgery (adjuvant).

In February 2024, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as a monotherapy as adjuvant treatment, for the treatment of resectable NSCLC at high risk of recurrence in adults, based on the KEYNOTE-671 trial.

The CHMP’s recommendation will now be reviewed by the EC for marketing authorization in the EU, and a final decision is expected in the first half of 2024.

In addition, Keytruda is under review in the EU and Japan in combination with Padcev (enfortumab vedotin-ejfv), an ADC, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma, based on the KEYNOTE-A39 trial that was conducted in collaboration with Seagen (now Pfizer) and Astellas.

Keytruda is also under review in the EU in combination with chemoradiotherapy for the treatment of patients with high-risk locally advanced cervical cancer, based on the KEYNOTE-A18 trial.

Additionally, Keytruda is under review in Japan in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, based on the KEYNOTE-859 trial.

Keytruda is also under review in Japan in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer, based on the KEYNOTE-966 trial.

Welireg is under review in the EU for the treatment of previously treated advanced renal cell carcinoma based on the LIGHTSPARK-005 clinical trial and for the treatment of von Hippel-Lindau disease based on the LIGHTSPARK-004 clinical trial.

Keytruda is under review in the EU and Japan for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, based on the Phase 2/3 IND.227/KEYNOTE-483 trial.

In November 2024, the EMA’s CHMP adopted a positive opinion recommending approval of Keytruda in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma.

In December 2024, the Company requested a re-examination from the EMA’s CHMP for an extension of the indication to include approval in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adults and adolescents aged 12 years and older with unresectable advanced or metastatic malignant pleural mesothelioma, based on final results from the KEYNOTE-483 trial.

The Company is diversifying its oncology portfolio and executing on its strategy which is broadly based on three strategic pillars:

2 unchanged sentences

Immuno-oncology

• Keytruda in the therapeutic areas of cutaneous squamous cell, hepatocellular, mesothelioma, ovarian and small-cell lung cancers.

• MK-1308A is the coformulation of quavonlimab, Merck’s novel investigational anti-CTLA-4 antibody, with pembrolizumab, being evaluated for the treatment of RCC.

• Subcutaneous MK-3475A, the coformulation of pembrolizumab with hyaluronidase, is being evaluated for comparability with the intravenous formulation of pembrolizumab in certain types of NSCLC.

• MK-4280A is the coformulation of favezelimab, Merck’s novel investigational anti-LAG3 therapy, with pembrolizumab, being evaluated for the treatment of colorectal cancer and hematological malignancies.

• MK-7684A is the coformulation of vibostolimab, an anti-TIGIT therapy, with pembrolizumab being evaluated for the treatment of certain types of melanoma, NSCLC and SCLC.

• V940 (mRNA-4157) is an investigational individualized neoantigen therapy being evaluated in combination with Keytruda as an adjuvant treatment in patients with certain types of melanoma in the INTerpath-001 clinical trial.

The FDA and EMA granted Breakthrough Therapy designation and PRIME scheme, respectively, for V940 (mRNA-4157) in combination with Keytruda for the adjuvant treatment of patients with certain stages of high-risk melanoma following complete resection.

V940 (mRNA-4157) is also being evaluated in the Phase 3 INTerpath-002 clinical trial as adjuvant treatment for certain patients with NSCLC.

V940 is being developed as part of a collaboration with Moderna.

• MK-1308A is the coformulation of quavonlimab, Merck’s novel investigational anti-CTLA-4 antibody, in combination with pembrolizumab, being evaluated for the treatment of RCC.

• MK-3475, Keytruda , is being evaluated in the therapeutic areas of hepatocellular, ovarian and small-cell lung cancers.

• MK-3475A is the subcutaneous coformulation of pembrolizumab in combination with hyaluronidase being evaluated for comparability with intravenous pembrolizumab in metastatic NSCLC.

• V940 (mRNA-4157) is an investigational individualized neoantigen therapy being evaluated in combination with Keytruda as an adjuvant treatment in patients with certain types of melanoma.

The FDA and EMA granted Breakthrough Therapy designation and Priority Medicines (PRIME) scheme designation, respectively, for V940 (mRNA-4157) in combination with Keytruda for the adjuvant treatment of patients with certain stages of high-risk melanoma following complete resection.

V940 (mRNA-4157) is also being evaluated as adjuvant and perioperative treatment for certain patients with NSCLC.

V940 is being developed as part of a collaboration with Moderna, Inc.

Precision molecular targeting

• MK-7339, Lynparza, is an oral PARP inhibitor being developed as part of a collaboration with AstraZeneca PLC.

The Company is currently evaluating Lynparza in combination with pembrolizumab for expanded indications in the therapeutic areas of NSCLC and SCLC.

• MK-7902, Lenvima, is an oral receptor tyrosine kinase inhibitor being evaluated in combination with Keytruda for expanded indications in the therapeutic areas of esophageal and gastric cancers.

Lenvima is being developed as part of a collaboration with Eisai Co., Ltd.

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• MK-1026, nemtabrutinib, is an oral, reversible, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, being evaluated for the treatment of hematological malignancies, including chronic lymphocytic leukemia and small lymphocytic lymphoma.

• MK-1084 is an investigational oral selective KRAS G12C inhibitor being evaluated in combination with Keytruda for the first-line treatment of certain patients with metastatic NSCLC.

• MK-3543, bomedemstat, is an investigational orally available lysine-specific demethylase 1 inhibitor, being evaluated for the treatment of certain patients with essential thrombocythemia.

Bomedemstat has FDA Orphan Drug and Fast Track Designation for the treatment of essential thrombocythemia and myelofibrosis, Orphan Drug Designation for the treatment of acute myeloid leukemia and Priority Medicines (PRIME) scheme designation by the EMA for the treatment of myelofibrosis.

• MK-5684 is an investigational cytochrome P450 11A1 (CYP11A1) inhibitor being evaluated for the treatment of certain patients with metastatic castration-resistant prostate cancer.

MK-5684 is being developed as part of a collaboration with Orion Corporation.

Bomedemstat has FDA

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Orphan Drug and Fast Track Designation for the treatment of essential thrombocythemia and myelofibrosis, Orphan Drug Designation for the treatment of acute myeloid leukemia and PRIME scheme designation by the EMA for the treatment of myelofibrosis.

• MK-5684, opevesostat, is an investigational cytochrome P450 11A1 (CYP11A1) inhibitor being evaluated for the treatment of certain patients with metastatic castration-resistant prostate cancer.

• MK-7339, Lynparza, is an oral PARP inhibitor being evaluated in combination with Keytruda for expanded indications in the therapeutic areas of NSCLC and SCLC.

Lynparza is being developed as part of a collaboration with AstraZeneca PLC.

• MK-7902, Lenvima, is an oral receptor tyrosine kinase inhibitor being evaluated in combination with Keytruda for expanded indications in the therapeutic area of esophageal cancer.

Lenvima is being developed as part of a collaboration with Eisai Co., Ltd.

Tissue targeting

• MK-2870, is an investigational trophoblast cell-surface antigen 2 (TROP2)-directed ADC, which is being evaluated for certain patients with NSCLC and certain patients with previously treated endometrial carcinoma.

MK-2870 is being developed as part of a collaboration with Kelun-Biotech.

The Company also terminated certain of its Phase 3 oncology development programs.

• The Company has discontinued development of ladiratuzumab vedotin, an ADC targeting LIV-1 which was being developed in collaboration with Seagen Inc.

(now Pfizer).

Additionally, in December 2023, the Company and Pfizer terminated their license and co-development agreement for Tukysa (tucatinib).

• In December 2023, Merck announced it was stopping the Phase 3 KEYLYNK-008 trial evaluating Keytruda in combination with maintenance Lynparza for the treatment of patients with metastatic squamous NSCLC.

Merck discontinued the study based on the recommendation of an independent Data Monitoring Committee, which reviewed data from a planned interim analysis.

At the interim analysis, Keytruda in combination with chemotherapy followed by Keytruda plus Lynparza did not demonstrate an improvement in overall survival, one of the study’s dual primary endpoints, compared to Keytruda in combination with chemotherapy followed by Keytruda plus placebo.

• Also in December 2023, Merck and Eisai announced that the Phase 3 LEAP-001 trial evaluating Keytruda plus Lenvima did not meet its dual primary endpoints of overall survival and progression-free survival for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H.

At the final analysis, Keytruda plus Lenvima did not improve overall survival or progression-free survival sufficiently to meet the study’s prespecified statistical criteria versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel).

The companies will work with investigators to share the results with the scientific community.

• MK-1022, patritumab deruxtecan, is being evaluated in the therapeutic area of NSCLC as noted above.

• MK-2140, zilovertamab vedotin, is an ADC targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1) being evaluated for the treatment of hematological malignancies, including diffuse large B cell lymphoma.

• MK-2400, ifinatamab deruxtecan, is an ADC being evaluated in patients with relapsed SCLC versus chemotherapy.

MK-2400 is being developed as part of a collaboration with Daiichi Sankyo.

• MK-2870, sacituzumab tirumotecan, is an investigational trophoblast cell-surface antigen 2 (TROP2)-directed ADC being evaluated for certain patients with breast, cervical, endometrial, gastric and non-small-cell lung cancers.

The FDA granted Breakthrough Therapy designation to sacituzumab tirumotecan for the treatment of patients with advanced or metastatic nonsquamous NSCLC with EGFR mutations whose disease progressed on or after tyrosine kinase inhibitor and platinum-based chemotherapy.

Sacituzumab tirumotecan is being developed as part of a collaboration with Kelun-Biotech.

Additionally, the Company currently has candidates in Phase 3 clinical development in several other therapeutic areas.

• MK-0616 is an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for hypercholesterolemia.

In 2023, the first participants enrolled in two registrational Phase 3 studies evaluating low-density lipoprotein (LDL) cholesterol reduction and a Phase 3 cardiovascular outcomes study.

• MK-1654, clesrovimab, is a respiratory syncytial virus (RSV) monoclonal antibody that is being evaluated for the prevention of RSV medically attended lower respiratory tract infection in infants and certain children over one year of age.

• MK-7240, tulisokibart, is a humanized monoclonal antibody directed to tumor necrosis factor-like ligand 1A, a target associated with both intestinal inflammation and fibrosis, being evaluated for the treatment of ulcerative colitis.

• MK-8591A is a new doravirine/islatravir once-daily oral combination of doravirine 100 mg and a lower dose of islatravir being evaluated, beginning in 2023, in a Phase 3 program in previously untreated adults and as a switch in antiretroviral therapy in virologically suppressed adults.

MK-8591, islatravir, is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) being evaluated for the treatment of HIV-1 infection.

In December 2021, the FDA placed clinical holds on the islatravir investigational new drug applications based on observations of decreases in total lymphocyte and CD4+ T-cell counts in some participants receiving islatravir in clinical studies.

In 2023, the Phase 2 clinical trial evaluating an oral once-weekly combination of a lower dose of islatravir and Gilead Sciences’ lenacapavir in virologically suppressed adults completed enrollment.

The investigational NDAs for the doravirine/islatravir and the islatravir +

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lenacapavir once-weekly treatment regimens remain under a partial clinical hold for any studies that would use islatravir doses higher than the doses considered for the revised clinical programs.

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

MK-3000 was obtained in connection with the July 2024 acquisition of Eyebiotech Limited.

• MK-8591A is a once-daily oral combination of doravirine and islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), being evaluated for the treatment of HIV infection in previously untreated adults and as a switch in antiretroviral therapy in virologically suppressed adults.

MK-8591D is an oral once-weekly combination of islatravir and Gilead Sciences Inc.’s lenacapavir being evaluated for the treatment of HIV infection in virologically suppressed adults.

In 2021, the FDA placed clinical holds on the islatravir investigational NDAs based on observations of decreases in total lymphocyte and CD4+ T-cell counts in some participants receiving islatravir in clinical studies.

The investigational NDAs for the doravirine/islatravir and the islatravir/lenacapavir once-weekly treatment regimens remain under a partial clinical hold for any studies that would use islatravir doses higher than the doses considered for the revised clinical programs.

• MK-0616, enlicitide decanoate, is an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for hypercholesterolemia, including in studies evaluating low-density lipoprotein cholesterol reduction and a cardiovascular outcomes study.

• 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 disease.

Merck is developing Lagevrio in collaboration with Ridgeback Biotherapeutics LP (Ridgeback).

The FDA granted Emergency Use Authorization for Lagevrio in December 2021, which was last reissued in October 2023.

The FDA granted Emergency Use Authorization for Lagevrio in December 2021, which was last reissued in November 2023.

Lagevrio is authorized for the treatment of adults with a current diagnosis of mild to moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

The authorization is based on the Phase 3 MOVe-OUT trial.

Lagevrio is not approved for any use in the U.S.

and is authorized only for the duration of the declaration that circumstances exist justifying the authorization of its emergency use under the Food, Drug and Cosmetic Act, unless the authorization is terminated or revoked sooner.

In November 2021, the EMA issued a positive scientific opinion for Lagevrio , which was intended to support national decision-making on the possible use of Lagevrio prior to marketing authorization.

In October 2021, the EMA initiated a rolling review for Lagevrio for the treatment of COVID-19 in adults.

In February 2023, Merck and Ridgeback announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the refusal of the marketing authorization application (MAA) for Lagevrio .

Merck and Ridgeback appealed the decision and requested a re-examination of the MAA.

In June 2023, Merck and Ridgeback announced that they have withdrawn the EU application for marketing authorization of Lagevrio based on the CHMP’s view that the data submitted are not sufficient to satisfy EU regulatory requirements for marketing authorization of Lagevrio .

Applications to other regulatory bodies are under review.

In 2024, an additional Phase 3 clinical trial

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(MOVe-NOW) was initiated to evaluate Lagevrio for the treatment of adults with COVID-19 at high risk for disease progression.

MOVe-NOW will build on existing Lagevrio data to assess efficacy in the current COVID-19 environment and support applications for licensure.

The Company also terminated certain of its development programs in 2024.

• MK-7264, gefapixant, is a non-narcotic, oral selective P2X3 receptor antagonist for the treatment of refractory or unexplained chronic cough in adults.

In December 2023, the FDA issued a second CRL regarding the resubmission of Merck’s NDA for gefapixant.

In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating refractory or unexplained chronic cough.

The CRL was not related to the safety of gefapixant.

Merck has withdrawn its application for gefapixant from the FDA and does not plan to refile.

• In December 2024, Merck announced the discontinuation of the Phase 3 KeyVibe-003 and KeyVibe-007 trials, which were evaluating MK-7684A, the fixed-dose combination of vibostolimab, an anti-TIGIT antibody, and pembrolizumab, in certain patients with NSCLC, based on the recommendation of an independent data monitoring committee.

In a pre-planned analysis, both trials met the pre-specified futility criteria for the primary endpoint of overall survival.

Considering the totality of data from the Phase 3 KeyVibe studies, including the efficacy outcomes from KeyVibe-003 and KeyVibe-007, the Company decided to discontinue the Phase 3 KeyVibe-006 trial and other vibostolimab studies.

• Also in December 2024, Merck announced the discontinuation of the clinical development program for favezelimab, an anti-LAG-3 antibody, and will stop enrollment in the Phase 3 KEYFORM-008 trial evaluating the fixed-dose combination of favezelimab and pembrolizumab (MK-4280A) in patients with relapsed or refractory cHL whose disease has progressed following prior anti-PD-1 therapy.

The Company made this decision after a thorough evaluation of data from the favezelimab clinical program.

Data analyses for the Phase 3 trials are ongoing, and the results will be shared with the scientific community.

• Based on the topline results of the MK-2060 Phase 2 study, Merck will not proceed to Phase 3 clinical development.

The Phase 2 study results will be presented at a scientific meeting later in 2025.

• The Phase 2b clinical trial for MK-8189 as a monotherapy for acute schizophrenia did not meet its primary efficacy endpoint and further development in schizophrenia, bipolar, and dementia indications has stopped.

Potential alternative indications for MK-8189 are being explored.

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The chart below reflects the Company’s research pipeline as of February 21, 2025.

2 unchanged sentences

Small molecules and biologics are given MK-number designations and vaccine candidates are given V-number designations.

Except as otherwise noted, candidates in Phase 1, additional indications in the same therapeutic area (other than with respect to cancer) and additional claims, line extensions or formulations for in-line products are not shown.

Except as otherwise noted, candidates in Phase 1, additional indications in the same therapeutic area (other than with respect to cancer and immunology) and additional claims, line extensions or formulations for in-line products are not shown.

MK-1022 (patritumab deruxtecan) (1)

Head and Neck

Hepatocellular

MK-1308 (quavonlimab) (2)

1 unchanged sentence

MK-1308A (quavonlimab+pembrolizumab)

MK-2140 (zilovertamab vedotin)

Hematological Malignancies

MK-2400 (ifinatamab deruxtecan) (1)

Small-Cell Lung

MK-2870 (1)(3)

Head and Neck

Hepatocellular

MK-2870 (sacituzumab tirumotecan) (1)(3)

Neoplasm Malignant

3 unchanged sentences

Cutaneous Squamous Cell

MK-4280 (favezelimab) (2)

Non-Small-Cell Lung

MK-4280A (favezelimab+pembrolizumab)

Cutaneous Squamous Cell

Hematological Malignancies

MK-5890 (boserolimab) (2)

Neoplasm Malignant

MK-5909 (raludotatug deruxtecan) (1)

MK-6482 Welireg (3)

2 unchanged sentences

Advanced Solid Tumors

MK-7684A (vibostolimab+pembrolizumab)

Head and Neck

Hepatocellular

MK-7902 Lenvima (1)(2)

Head and Neck

Dengue Fever Virus Vaccine

1 unchanged sentence

MK-8591B (islatravir+MK-8507) (4)

MK-8591D (islatravir+lenacapavir) (1)(5)

HIV-1 Prevention

Nonalcoholic Steatohepatitis (NASH)

HIV-1 Pre-Exposure Prophylaxis

MK-7240 (tulisokibart)

Systemic Sclerosis

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MK-6024 (efinopegdutide)

Pulmonary Arterial Hypertension

Pulmonary Hypertension-Chronic Obstructive Pulmonary Disease

Pulmonary Hypertension Due To Left Heart Disease

MK-7962 (sotatercept)

Schizophrenia

Systemic Lupus Erythematosus

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MK-7962 Winrevair

Table of Content s

Phase 3 (Phase 3 entry date) Under Review

5 unchanged sentences

Hematological Malignancies (March 2023)

Non-Small-Cell Lung (May 2024)

MK-1308A (quavonlimab+pembrolizumab)

Renal Cell (April 2021)

MK-2870 (1)(3)

MK-2140 (zilovertamab vedotin)

Hematological Malignancies (September 2024)

MK-2400 (ifinatamab deruxtecan) (1)

Small-Cell Lung (July 2024)

MK-2870 (sacituzumab tirumotecan) (1)(3)

Breast (April 2024)

Cervical (July 2024)

Endometrial (December 2023)

Gastric (May 2024)

Non-Small-Cell Lung (November 2023)

MK-3475 Keytruda

Cutaneous Squamous Cell (August 2019) (EU)

Hepatocellular (May 2016) (EU)

Mesothelioma (May 2018)

Ovarian (December 2018)

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MK-3543 (bomedemstat)

Myeloproliferative Disorders

MK-4280A (favezelimab+pembrolizumab)

Colorectal (November 2021)

Hematological Malignancies (October 2022)

Myeloproliferative Disorders (December 2023)

MK-5684 (opevesostat)

Prostate (December 2023)

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Small-Cell Lung (December 2020)

MK-7684A (vibostolimab+pembrolizumab)

Melanoma (January 2023)

Non-Small-Cell Lung (April 2021)

Small-Cell Lung (March 2022)

MK-7902 Lenvima (1)(2)

Esophageal (July 2021)

Gastric (December 2020)

Melanoma (July 2023)

Non-Small-Cell Lung (December 2023)

Diabetic Macular Edema

HIV-1 Infection

MK-8591A (doravirine+islatravir) (February 2020) (5)

MK-8591D (islatravir+lenacapavir) (October 2024) (1)(5)

Hypercholesterolemia

MK-0616 (August 2023)

Pneumococcal Vaccine Adult

V116 (July 2022) (EU)

Respiratory Syncytial Virus

MK-1654 (clesrovimab) (November 2021)

Ulcerative Colitis

MK-7240 (tulisokibart) (October 2023)

MK-0616 (enlicitide decanoate) (August 2023)

MK-7240 (tulisokibart)

Crohn’s Disease (June 2024)

Ulcerative Colitis (October 2023)

New Molecular Entities

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MK-6482 Welireg

Von Hippel-Lindau (VHL) Disease (EU)

MK-7264 (gefapixant) (U.S.) (8)

Renal Cell (JPN)

Von Hippel-Lindau (VHL)

Disease (JPN)

Pneumococcal Vaccine Adult

V116 Capvaxive (EU) (JPN)

Pulmonary Arterial Hypertension

MK-7962 (sotatercept) (U.S.) (EU)

MK-7962 Winrevair (JPN)

Respiratory Syncytial Virus

MK-1654 (clesrovimab) (U.S.) (EU)

Certain Supplemental Filings

MK-3475 Keytruda

• Primary Advanced or Recurrent Endometrial Carcinoma

(KEYNOTE-868) (U.S.)

• Resectable Stage II, IIIA or IIIB NSCLC

• First-Line Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

(KEYNOTE-483) (EU) (JPN)

• First-Line Locally Advanced or Metastatic Urothelial Cancer

(KEYNOTE-A39) (EU) (JPN)

• High-Risk Locally Advanced Cervical Cancer

(KEYNOTE-A18) (EU)

• First-Line HER2 Negative Locally Advanced Unresectable or Metastatic Gastric Cancer

(KEYNOTE-859) (JPN)

• First-Line Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

(KEYNOTE-966) (JPN)

MK-6482 Welireg

• Previously Treated Advanced Renal Cell Carcinoma

(LIGHTSPARK-005) (EU)

• Advanced, Unresectable, or Metastatic Pheochromocytoma and Paraganglioma

(LITESPARK-015) (U.S.)

(1) Being developed in a collaboration.

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(3) Being developed as monotherapy and/or in combination with Keytruda.

(4) On FDA clinical hold.

(5) On FDA partial clinical hold for higher doses than those used in current clinical trials.

(6) Phase 2b development costs are being co-funded.

(4) FDA lifted clinical hold on December 4, 2024.

(5) On FDA partial clinical hold for higher doses of islatravir than those used in current clinical trials.

(6) Available in the U.S.

under Emergency Use Authorization.

(8) In December 2023, the FDA issued a CRL for the NDA for gefapixant.

Merck is reviewing the FDA’s feedback to determine next steps.

(7) Program is in a Phase 2/3 study that commenced in August 2024.

(8) In June 2024, the FDA issued a CRL for the BLA for patritumab deruxtecan.

Merck is working with Daiichi Sankyo to address FDA feedback.

Human Capital

As of December 31, 2023, the Company had approximately 72,000 employees worldwide, with approximately 29,000 employed in the U.S., including Puerto Rico, and, additionally, approximately 15,000 third-party contractors globally.

As of December 31, 2024, the Company had approximately 75,000 employees worldwide, with approximately 31,000 employed in the U.S., including Puerto Rico, and approximately 15,000 third-party contractors globally.

Third-party contractors include the Company’s temporary workers, independent contractors, and freelancers who are viewed as full-time equivalent employees;

they exclude outsourced service providers.

Approximately 73,000 of the Company’s employees are full-time employees.

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Approximately 21% of the Company’s employees are represented by various collective bargaining groups.

The Company’s voluntary turnover rate was approximately 5.6% and 8.5%, respectively, in 2023 and 2022.

The Company recognizes that its employees are critical to meet the needs of its patients and customers and that its ability to excel depends on the integrity, skill, and diversity of its employees.

(1) Third party contractors include the Company’s temporary workers, independent contractors, and freelancers who are viewed as full-time equivalent employees.

They exclude outsourced service providers.

The Company’s voluntary turnover rate was approximately 4.6% and 5.6%, in 2024 and 2023, respectively.

The Company recognizes that its employees are critical to meet the needs of its patients and customers and that its ability to excel depends on the integrity, skill, and collaboration of its employees.

Talent Acquisition

The Company uses a comprehensive approach to ensure recruiting, retention and leadership development goals are systematically executed throughout the Company and that it hires talented leaders to achieve improved gender parity and representation across all dimensions of diversity.

The Company provides training to its

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managers and external recruiting organizations on strategies to mitigate unconscious bias in the candidate selection and hiring process.

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range of knowledge, skills, backgrounds and perspectives.

In addition, the Company utilizes a comprehensive communications strategy, employee branding and marketing outreach, social media and strategic alliance partnerships to reach a broad pool of talent in its critical business areas.

In 2023, the Company hired approximately 8,200 employees across the globe through various channels including the Company’s external career site, direct passive candidate sourcing, diversity partnerships, employee referrals, universities and other external sources.

Global Diversity and Inclusion

Diversity and inclusion are fundamental to the Company’s success and core to future innovation.

The Company fosters a globally diverse and inclusive workforce for its employees by creating an environment of belonging, engagement, equity, and empowerment.

The Company is proactive and intentional about diversity hiring and development programs to advance talent.

The Company creates competitive advantages by leveraging diversity and inclusion to accelerate business performance.

This includes fostering global supplier diversity, integrating diversity and inclusion into the Company’s commercialization strategies and leveraging employee insights to improve performance.

In addition to these efforts, the Company has ten Employee Business Resource Groups that provide opportunities for employees to take an active part in contributing to the Company’s inclusive culture through their work in talent acquisition and development, business and customer insights and social and community outreach.

Gender and Ethnicity Data (1)

2023 2022 2021

Women on the Board of Directors 46% 46% 46%

Women in senior management roles (2)

Women in management roles (3)

Women in the workforce 51% 50% 50%

New hires that were women 53% 52% 53%

Members of underrepresented ethnic groups on the Board of Directors 15% 15% 23%

Members of underrepresented ethnic groups in senior management roles (U.S.) (2)

Members of underrepresented ethnic groups in management roles (U.S.) (3)

Members of underrepresented ethnic groups in the workforce (U.S.) 35% 34% 32%

New hires that were members of underrepresented ethnic groups (U.S.) 47% 47% 46%

(1) As of 12/31.

As self-identified to the Company.

(2) “Senior management role” is defined as an individual holding either a Vice President or Senior Vice President title.

(3) “Management role” is defined as all managers with direct reports.

In 2024, the Company hired approximately 7,300 employees across the globe through various channels including the Company’s external career site, direct passive candidate sourcing, employee referrals, universities and other external sources.

Enabling a Collaborative Work Environment

Fostering a collaborative environment is fundamental to the Company’s success and core to future innovation.

The Company strives to create an environment of acceptance, engagement and empowerment.

The Company seeks to hire and develop the best talent by providing equal opportunity to all people.

The Company creates competitive advantages by leveraging practices which help to meet the needs of all our patients worldwide.

This includes evaluating social determinants of health when developing commercialization strategies and leveraging employee insights to improve performance.

Compensation and Benefits

The Company provides a valuable suite of compensation and benefits programs that reflect its commitment to attract, retain and motivate its talent, and support its employees and their families in every stage of life.

The Company continuously monitors and adjusts its compensation and benefit programs to ensure they are competitive, contemporary, helpful and engaging, and that they support strategic imperatives such as diversity and inclusion, equity, flexibility, quality, security and affordability.

For example, the Company regularly monitors and evaluates its pay practices and policies to ensure that it is paying employees equitably across all genders, races and ethnicities.

The Company continuously monitors and adjusts its compensation and benefit programs to ensure they are competitive, contemporary, helpful and engaging, and that they support strategic imperatives such as fairness, flexibility, quality, security and affordability.

For example, the Company regularly monitors and evaluates its pay practices and policies to ensure that it is paying employees fairly.

The Company offers a personal health care concierge service to assist U.S.

employees participating in the Company medical plan with their health care needs.

Aligned with its business and in support of its cancer care strategy, the Company provides enhanced cancer screening benefits with cash incentives, immediate access to a leading cancer center of excellence for U.S.

Aligned with its business and in support of its cancer care strategy, the Company provides enhanced cancer screening benefits with cash incentives, immediate access to two leading cancer centers of excellence for U.S.

employees and high value cancer support resources (e.g., caregiving and mental health) for employees and their families.

Globally, the Company implemented a minimum standard of 12 weeks of paid parental leave, which inclusively applies to all parents.

Globally, the Company implemented a minimum standard of 12 weeks of paid parental leave.

In the U.S., the Company’s benefits rank in the top quartile of Fortune 100 companies under the Aon 2024 Benefits Index.

The Company has been included in the Seramount (previously the Working Mother) 100 Best Companies ranking for 38 consecutive years and was named a top ten Best Company for Moms in 2024.

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Employee Well-being

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The Company’s programs ensure quality, competitive value, protection from significant financial hardship and access to tools and resources to support employees and their families in all stages of their career and their lives, earning the Company accolades such as the Business Group on Health’s Best Employers Excellence in Health & Well-being and the CEO Roundtable on Cancer’s Global Gold Standard Employer accreditation in 2024.

The Company fosters an array of flexible work arrangements that includes flextime, summer hours, remote work, telework, job sharing and part-time work to help employees succeed personally as well as professionally.

As part of the Company’s overall culture of well-being, it also offers onsite services so employees can thrive.

For example, in the U.S., these include onsite health care professionals at many major sites, cafeterias committed to healthy menu offerings, onsite childcare, onsite gyms, and the convenient option to bank through the two employee credit unions.

As part of the Company’s overall culture of well-being, the Company fosters an array of flexible work arrangements and offers onsite services so employees can thrive.

Engaging Employees

The Company strives to foster employee engagement by promoting a safe, positive, diverse, and inclusive work environment that provides numerous opportunities for two-way communication with employees.

Some of the Company’s key programs and initiatives include promoting global employee engagement surveys, ongoing pulse checks to the organization for interim feedback on specific topics, fostering professional networking and collaboration, identifying and providing opportunities for volunteering and establishing positive, cooperative business relations with designated employee representatives.

The Company strengthens employee engagement by fostering a safe, positive, and supportive workplace.

Merck encourages candid employee feedback through global employee surveys and peer feedback processes.

The Company encourages professional networking and collaboration, enabling employees to connect and grow.

Additionally, Merck provides community volunteering opportunities, reflecting its commitment to social responsibility.

By building strong relationships with its employees, the Company strives to ensure that every voice is heard, fostering an engaging employee experience that drives Merck forward.

Talent Management and Development

As the Company pursues its goal of becoming the world’s premier research-based biopharmaceutical company, there is a consistent focus on the importance of continuously developing its diverse and talented people.

The Company is committed to talent growth for all, allowing its employees to move more fluidly across the organization, unlocking an environment that allows them to shape their career pathways via non-linear and inclusive opportunities and experience.

Merck’s current talent management system supports company-wide performance management, leadership development, talent reviews and succession planning.

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This includes, but is not limited to, building leadership and management skills, as well as providing technical and functional training to all employees.

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Environmental Matters

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The Company ensures its ongoing commitment to these areas through thoughtful governance.

The Company’s efforts in this area are overseen by its Environmental Health and Safety (EHS) Council.

The Company’s EHS Council is a cross-functional body with leadership representation from each area of the Company’s business including top-level executives.

The EHS Council provides enterprise leadership and sponsorship for the Company’s environmental sustainability strategy, monitors progress towards the Company’s public targets and influences decisions for environmental sustainability strategy implementation, while increasing visibility and transparency internally to the business, executive team and the Board of Directors.

In addition, the Company’s Environmental Sustainability Implementation Steering Committee, also comprising top-level executives, oversees progress of initiatives at the enterprise level and provides support and guidance on the implementation plans and resourcing of the Company’s environmental sustainability strategy globally.

This steering committee is informed by leaders from the Environmental Sustainability Center of Excellence (CoE), Global Energy & Sustainability CoE and Energy Procurement CoE, who develop the Company’s goals in alignment with stakeholder expectations, track their progress, and develop and provide continuous improvement on plans to achieve and sustain the Company’s public commitments.

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Its Environmental, Health and Safety Council (EHS Council) is a cross-functional body with leadership representation from each area of the Company’s business and is responsible for overseeing its environmental sustainability strategy, policy, and risk mitigation controls.

The EHS Council monitors performance against the Company’s goals and increases transparency on environmental issues within the Company, senior management, and the Board of Directors (the Board).

The Global Safety and Environment (GSE) vice president communicates progress on environmental sustainability goals, objectives and other important issues to the Board, senior management and the EHS Council.

Additionally, the head of the Environmental Sustainability Center of Excellence is a member of the Environmental, Social and Governance Strategy Management Team, a group of functional experts that advises, shapes, and drives the Company’s long-term sustainability strategy with guidance from an internal cross divisional forum of senior leaders.

The Company’s cross-functional Environmental Sustainability Implementation Steering Committee was designated by the EHS Council to oversee the progress of initiatives that support the achievement of the Company’s public goals and provide guidance on resourcing of the Company’s environmental sustainability strategy.

Merck believes that climate change could present risks to its business, as discussed in further detail in Item 1A.

“Risk Factors” below under the headings “Climate change or legal, regulatory or market measures to address climate change may negatively affect the Company’s business, results of operations, cash flows and prospects” and “Environmental, social and governance (ESG) matters may impact the Company’s business and reputation.” Some of the potential impacts of climate change to the Company’s business include increased operating costs due to additional regulatory requirements, physical risks to the Company’s facilities, water limitations and disruptions to its supply chain.

These potential risks are integrated into the Company’s business planning, including investment in reducing energy usage, water use and greenhouse gas emissions.

“Risk Factors” below under the headings “Climate change or legal, regulatory or market measures to address climate change may negatively affect the Company’s business, results of operations, cash flows and prospects” and “Environmental, social and governance matters may impact the Company’s business and reputation.” Some of the potential impacts of climate change to the Company’s business include increased operating costs due to additional regulatory requirements, physical risks to the Company’s facilities, water limitations and disruptions to its supply chain.

These potential risks are integrated into the Company’s business planning, including investment in reducing energy usage, water use and greenhouse gas (GHG) emissions.

The Company has adopted a set of climate goals to help position it to succeed in an increasingly resource-constrained world.

These goals were developed to align with the latest climate science and address the rising expectations of the Company’s customers, investors, external stakeholders and employees regarding the environmental impact of its operations and supply chain.

The Company’s climate goals include reducing Scope 1 and 2 operational greenhouse gas emissions 46% by 2030 (from a 2019 baseline), achieving carbon neutrality for Scope 1 and 2 greenhouse emissions across operations by 2025, sourcing 100% of its purchased electricity from renewable sources by 2025, and reducing Scope 3 greenhouse gas emissions 30% by 2030 (from a 2019 baseline).

The Company has also committed to the Science-Based Targets initiative (SBTi) to set a net-zero target for its greenhouse gas emissions across its global operations (Scopes 1, 2, and 3).

These goals address the rising expectations of the Company’s customers, investors, external stakeholders and employees regarding the environmental impact of its operations and supply chain.

The Company’s climate goals include reducing Scope 1 and 2 operational GHG emissions 46% by 2030 (from a 2019 baseline), sourcing 100% of its purchased electricity from renewable sources by 2025, and reducing Scope 3 GHG emissions 30% by 2030 (from a 2019 baseline).

In 2024, the Company committed to a net-zero target for its GHG emissions across its global operations (Scopes 1, 2 and 3) by 2045, aligned with the guidelines of the Science Based Targets initiative (SBTi).

Other environmental sustainability initiatives of the Company include:

• Partnering for progress across the Company’s value chain.

The Company is working to reduce its Scope 3 emissions through a robust supplier engagement approach to drive collaboration upstream and downstream in its value chain.

By engaging with its suppliers, the Company can identify key ways to reduce its GHG emissions and pinpoint additional tangible benefits for the business.

• Playbooks for a sustainable environment.

The Company’s local sites are crucial to achieving its ambitious environmental sustainability goals, and the Company continues to launch tools to assist them, particularly for its climate and waste targets.

To help direct and track projects in support of its goals, the Company has developed a series of guidance documents for its global sites.

In 2021, the Company launched its Low Carbon Transition Playbook (LCTP), a common platform that includes a gap assessment to help the Company’s global sites evaluate the maturity of their energy programs and help create short- and long-term plans to reduce sites’ carbon intensity and build toward a low-carbon future.

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In 2022, the Company also created the Waste Diversion Playbook, which takes a similar approach to guide sites on developing a roadmap to their and the Company’s shared 2025 goals on waste diversion, including local waste-diversion strategies and environmentally responsible procurement practices.

These tools aid in the reporting and tracking of projects that support achievements towards meeting the Company’s corporate targets.

In 2024, the Company expanded this list with the addition of a Water Conservation Playbook.

This approach guides projects consistently across the Company’s global network of sites and enables continuous improvement toward meetings its goals.

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• Realizing the benefits of green and sustainable science .

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The Company utilizes an innovative “green-by-design” development strategy with a goal to progress from an initial early clinical supply route to a fully optimized and sustainable commercial manufacturing process.

In 2023, for the fourth year in a row, the Company received the Peter J.

In 2024, for the fifth year in a row, the Company received the Peter J.

Dunn Award for Green Chemistry and Engineering Impact, an award given by the American Chemical Society in recognition of outstanding implementation of novel green chemistry in the pharmaceutical industry.

• Partnering for progress across the Company’s value chain.

The Company is engaging with its strategic suppliers to identify ways to reduce greenhouse gas emissions in its supply chain.

• Waste diversion .

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As water is a key input to the Company’s manufacturing operations, the Company assesses water risk throughout its network as a standard business practice.

Both of the Company’s priority water-stress risk sites have conservation plans in place and are actively working on water use reduction and recycling improvement projects.

These projects are consistent with the Company’s ongoing commitment to achieving its stated target of maintaining global water use at or below 2015 levels by 2025.

Both of the Company’s priority water-stress risk sites have conservation plans in place, and site staff are actively working on water use reduction and recycling improvement projects.

These projects are consistent with the Company’s ongoing commitment to achieving its stated goal of maintaining global water use at or below 2015 levels by 2025.

The Company’s sites are employing various technologies and techniques aimed at reducing its water footprint and improving operational performance.

The Company’s

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continued endorsement of the United Nations CEO Water Mandate enables continued alignment of the Company’s water program with the mandate’s principles directly in the Company’s operations.

The Company’s endorsement of the United Nations CEO Water Mandate enables alignment of the Company’s water program with the mandate’s principles.

The Company has continued to identify partnerships to help it advance its water stewardship priorities in the areas in which it operates.

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Sales worldwide by subsidiaries outside the U.S.

as a percentage of total Company sales was 53% in 2023 and 54% in both 2022 and 2021.

as a percentage of total Company sales was 50% in 2024, 53% in 2023 and 54% in 2022.

The Company’s worldwide business is subject to risks of currency fluctuations, governmental actions and other governmental proceedings abroad.

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However, the Company closely reviews its methods of operations and adopts strategies responsive to changing economic and political conditions.

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Merck has operations in countries located in Latin America, the Middle East, Africa, Eastern Europe and Asia Pacific.

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The Company’s corporate governance guidelines and the charters of the Board of Directors’ four standing committees are available on the Company’s website at www.merck.com/company-overview/leadership/board-of-directors/ and all such information is available in print to any shareholder who requests it from the Company.

The Company’s 2022/2023 Impact Report, which provides enhanced ESG disclosures, is available on the Company’s website at www.merck.com/company-overview/esg/esg-resources/.

The Company’s 2023/2024 Impact Report, which provides enhanced sustainability disclosures, is available in the Sustainability section of the Company’s website at www.merck.com.

Information in the Company’s Impact Report is not incorporated by reference into this Form 10-K.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business