Merck & Co., Inc., Rahway, N.J., USA Announces Fourth-Quarter and Full-Year 2025 Financial Results; Highlights Progress Advancing Broad, Diverse Pipeline
Key Terms
gaap financial
non-gaap financial
phase 3 medical
ldl-c medical
fda regulatory
medicare part d regulatory
eps financial
Reports Strength in Oncology and Animal Health, Plus Increasing Contributions From WINREVAIR and CAPVAXIVE
-
Fourth-Quarter Worldwide Sales Were
($16.4 Billion 5% Growth;4% Growth ex-FX) -
Fourth-Quarter GAAP EPS Was
; Non-GAAP EPS Was$1.19 ; GAAP and Non-GAAP EPS Include a Charge of$2.04 per Share for the Acquisition of MK-8690 Sole Global Rights$0.05 -
Full-Year Worldwide Sales Were
($65.0 Billion 1% Growth;2% Growth ex-FX)-
KEYTRUDA/KEYTRUDA QLEX Sales Were
($31.7 Billion 7% Growth Both Nominally and ex-FX); Includes KEYTRUDA QLEX Sales of$40 Million -
WINREVAIR Sales Were
$1.4 Billion -
CAPVAXIVE Sales Were
$759 Million -
GARDASIL/GARDASIL 9 Sales Were
($5.2 Billion 39% Decline Both Nominally and ex-FX) -
Animal Health Sales Were
($6.4 Billion 8% Growth;9% Growth ex-FX)
-
KEYTRUDA/KEYTRUDA QLEX Sales Were
-
Full-Year 2025 GAAP EPS Was
; Non-GAAP EPS Was$7.28 ; GAAP and Non-GAAP EPS Include Charges of$8.98 per Share Related to Certain Business Development Transactions$0.20 - Announced Positive Late-Stage Trial Results From 18 Phase 3 Trials in 2025
- Augmented Pipeline and Portfolio Through Acquisitions of Verona Pharma and Cidara Therapeutics and License Agreement With Hengrui Pharma
-
In the Fourth Quarter
- Received FDA Commissioner’s National Priority Vouchers for Enlicitide and Sacituzumab Tirumotecan (Sac-TMT), Providing an Opportunity To Expedite Potential FDA Review Timelines for These Phase 3 Candidates
- Presented Positive Results From Phase 3 CORALreef Lipids and HeFH Trials Demonstrating Enlicitide Significantly Reduced LDL-C in Adults
-
Reached Agreement With
U.S. Government To Expand Access to Medicines and Lower Costs for Americans
-
Full-Year 2026 Financial Outlook
-
Anticipates Worldwide Sales To Be Between
and$65.5 Billion $67.0 Billion -
Expects Non-GAAP EPS To Be Between
and$5.00 ; Outlook Reflects a One-Time Charge of Approximately$5.15 per Share for the Acquisition of Cidara$3.65
-
Anticipates Worldwide Sales To Be Between
"In 2025, we continued to advance leading-edge science to deliver transformative medicines and vaccines that are improving health outcomes for patients around the world,” said Robert M. Davis, chairman and chief executive officer. "Our business benefited from demand for our innovative portfolio, including for KEYTRUDA, increasing contributions from new launches in cardiometabolic and respiratory as well as vaccines, and strong performance of Animal Health. The transformation of our portfolio, bolstered by the acquisitions of Verona Pharma and Cidara Therapeutics, is well underway, and momentum is building as we continue to execute on our strategy. Our progress positions us to continue delivering on our purpose for patients and creating durable value for shareholders.”
Financial Summary
$ in millions, except EPS amounts |
Fourth Quarter |
Year Ended |
||||||
2025 |
2024 |
Change |
Change Ex-Exchange |
Dec. 31, 2025 |
Dec. 31, 2024 |
Change |
Change Ex-Exchange |
|
Sales |
|
|
|
|
|
|
|
|
GAAP net income1 |
2,963 |
3,743 |
- |
- |
18,254 |
17,117 |
|
|
Non-GAAP net income that excludes certain items1,2* |
5,088 |
4,372 |
|
|
22,513 |
19,444 |
|
|
GAAP EPS |
1.19 |
1.48 |
- |
- |
7.28 |
6.74 |
|
|
Non-GAAP EPS that excludes certain items2* |
2.04 |
1.72 |
|
|
8.98 |
7.65 |
|
|
*Refer to table on page 9. |
||||||||
Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was
Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in 2025 also excludes a net tax benefit, which reflects a net benefit related to favorable audit reserve adjustments. Non-GAAP EPS in the fourth quarter and full year of 2024 also exclude a benefit due to a reduction in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years.
Fourth-Quarter Sales Performance
The following table reflects sales of the Company’s top products and significant performance drivers.
|
Fourth Quarter |
||||
$ in millions |
2025 |
2024 |
Change |
Change Ex-Exchange |
Commentary |
Total Sales |
|
|
|
|
|
Pharmaceutical |
14,843 |
14,042 |
|
|
Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by a decline in vaccines. |
KEYTRUDA/ KEYTRUDA QLEX |
8,372 |
7,836 |
|
|
Growth driven by strong global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), renal cell carcinoma, cervical and head and neck cancers, as well as continued global demand in metastatic indications, including urothelial, gastric and endometrial cancers. Sales growth was partially offset by timing of purchases in the |
GARDASIL/
|
1,031 |
1,550 |
- |
- |
Decline primarily due to lower demand in |
PROQUAD, M-M-R II and VARIVAX |
619 |
594 |
|
|
Increase primarily reflects higher sales of PROQUAD, which largely resulted from both the replenishment of doses borrowed from the |
JANUVIA/JANUMET |
501 |
487 |
|
|
Growth driven by higher net pricing in the |
BRIDION |
499 |
449 |
|
|
Growth primarily due to higher demand and net pricing in the |
WINREVAIR |
467 |
200 |
|
|
Growth primarily reflects continued uptake in the |
Lynparza* |
389 |
365 |
|
|
Growth primarily due to higher demand in several international markets. |
CAPVAXIVE |
279 |
50 |
N/M |
N/M |
Growth largely due to continued uptake in the |
PREVYMIS |
275 |
215 |
|
|
Increase primarily due to higher demand in the |
Lenvima* |
272 |
255 |
|
|
Increase due to higher sales in the |
WELIREG |
220 |
160 |
|
|
Growth primarily due to higher demand in the |
OHTUVAYRE |
178 |
- |
- |
- |
Represents sales following the Company's Oct. 7, 2025 acquisition of Verona Pharma plc (Verona Pharma). |
Animal Health |
1,505 |
1,397 |
|
|
Growth primarily due to higher demand of livestock products. |
Livestock |
987 |
889 |
|
|
Growth primarily driven by higher demand across all species, as well as improved supply and new product launches. |
Companion Animal |
518 |
508 |
|
|
Growth from new product launches was partially offset by lower demand for other products in portfolio, reflecting a reduction in veterinary visits. Sales of BRAVECTO line of products were |
Other Revenues** |
52 |
185 |
- |
- |
Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements. |
*Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. |
**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. |
N/M - Not meaningful. |
Full-Year Sales Performance
The following table reflects sales of the Company’s top products and significant performance drivers.
|
Year Ended |
|||
$ in millions |
Dec. 31, 2025 |
Dec. 31, 2024 |
Change |
Change Ex-Exchange |
Total Sales |
|
|
|
|
Pharmaceutical |
58,142 |
57,400 |
|
|
KEYTRUDA/KEYTRUDA QLEX |
31,680 |
29,482 |
|
|
GARDASIL/GARDASIL 9 |
5,233 |
8,583 |
- |
- |
JANUVIA/JANUMET |
2,544 |
2,268 |
|
|
PROQUAD, M-M-R II and VARIVAX |
2,451 |
2,485 |
- |
- |
BRIDION |
1,841 |
1,764 |
|
|
Lynparza* |
1,450 |
1,311 |
|
|
WINREVAIR |
1,443 |
419 |
N/M |
N/M |
Lenvima* |
1,053 |
1,010 |
|
|
PREVYMIS |
978 |
785 |
|
|
VAXNEUVANCE |
825 |
808 |
|
|
CAPVAXIVE |
759 |
97 |
N/M |
N/M |
WELIREG |
716 |
509 |
|
|
ROTATEQ |
673 |
711 |
- |
- |
Reblozyl* |
525 |
371 |
|
|
LAGEVRIO |
380 |
964 |
- |
- |
Simponi** |
- |
543 |
- |
- |
Animal Health |
6,354 |
5,877 |
|
|
Livestock |
3,896 |
3,462 |
|
|
Companion Animal |
2,458 |
2,415 |
|
|
Other Revenues*** |
515 |
891 |
- |
- |
*Alliance revenue for Lynparza and Lenvima represent the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. Alliance revenue for Reblozyl represents royalties. |
**Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024. |
***Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. |
N/M - Not meaningful. |
In addition, Koselugo alliance revenue was
Full-year 2025 Pharmaceutical sales were
Full-year 2025 Animal Health sales were
Fourth-Quarter and Full-Year Expense and Related Information
The table below presents selected expense information.
$ in millions |
GAAP |
Acquisition-
|
Restructuring
|
(Income)
|
Non-
|
Fourth Quarter 2025 |
|||||
Cost of sales |
|
|
|
$- |
|
Selling, general and administrative |
2,898 |
48 |
2 |
- |
2,848 |
Research and development |
3,886 |
5 |
(111) |
- |
3,992 |
Restructuring costs |
213 |
- |
213 |
- |
- |
Other (income) expense, net |
432 |
- |
- |
206 |
226 |
|
|
|
|
|
|
Fourth Quarter 2024 |
|
|
|
|
|
Cost of sales |
|
|
|
$- |
|
Selling, general and administrative |
2,864 |
29 |
16 |
- |
2,819 |
Research and development |
4,585 |
12 |
(1) |
- |
4,574 |
Restructuring costs |
51 |
- |
51 |
- |
- |
Other (income) expense, net |
126 |
(31) |
- |
152 |
5 |
$ in millions |
GAAP |
Acquisition-
|
Restructuring
|
(Income)
|
Non-
|
Year Ended Dec. 31, 2025 |
|||||
Cost of sales |
|
|
|
$- |
|
Selling, general and administrative |
10,733 |
120 |
3 |
- |
10,610 |
Research and development |
15,789 |
19 |
175 |
- |
15,595 |
Restructuring costs |
889 |
- |
889 |
- |
- |
Other (income) expense, net |
151 |
(3) |
- |
(306) |
460 |
|
|
|
|
|
|
Year Ended Dec. 31, 2024 |
|
|
|
|
|
Cost of sales |
|
|
|
$- |
|
Selling, general and administrative |
10,816 |
117 |
83 |
- |
10,616 |
Research and development |
17,938 |
72 |
1 |
- |
17,865 |
Restructuring costs |
309 |
- |
309 |
- |
- |
Other (income) expense, net |
(24) |
(79) |
- |
45 |
10 |
GAAP Expense, EPS and Related Information
Gross margin was
Selling, general and administrative (SG&A) expenses were
Research and development (R&D) expenses were
Other (income) expense, net, was
The effective tax rate was
GAAP EPS was
Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was
Non-GAAP SG&A expenses were
Non-GAAP R&D expenses were
Non-GAAP other (income) expense, net, was
The non-GAAP effective tax rate was
Non-GAAP EPS was
A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.
Fourth Quarter |
Year Ended |
|||
$ in millions, except EPS amounts |
2025 |
2024 |
Dec. 31, 2025 |
Dec. 31, 2024 |
EPS |
|
|
|
|
GAAP EPS |
|
|
|
|
Difference |
0.85 |
0.24 |
1.70 |
0.91 |
Non-GAAP EPS that excludes items listed below2 |
|
|
|
|
|
|
|
|
|
Net Income |
|
|
|
|
GAAP net income1 |
|
|
|
|
Difference |
2,125 |
629 |
4,259 |
2,327 |
Non-GAAP net income that excludes items listed below1,2 |
|
|
|
|
|
|
|
|
|
Excluded Items: |
|
|
|
|
Acquisition- and divestiture-related costs3 |
|
|
|
|
Restructuring costs |
1,277 |
187 |
2,551 |
888 |
Loss (income) from investments in equity securities |
206 |
152 |
(306) |
45 |
Decrease to net income before taxes |
2,590 |
1,050 |
5,252 |
3,452 |
Estimated income tax (benefit) expense4 |
(465) |
(421) |
(993) |
(1,125) |
Decrease to net income |
|
|
|
|
Pipeline and Portfolio Highlights
In 2025, the Company announced positive late-stage trial results from 18 Phase 3 trials and began enrolling patients in 21 new Phase 3 studies evaluating multiple indications and therapeutic areas, with approximately 80 Phase 3 studies currently underway.
Throughout the fourth quarter, the Company made important progress to advance its broad, diverse pipeline, meeting significant regulatory and clinical milestones.
-
Oncology:
-
U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, for the perioperative treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy based on Phase 3 KEYNOTE-905 trial.- Approvals represent the first PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens for this patient population.
- FDA awarded a priority review voucher under the Commissioner’s National Priority Voucher (CNPV) pilot program for sac-TMT, an investigational anti-TROP2 ADC being developed in collaboration with Kelun-Biotech.
-
European Commission (EC) approved the subcutaneous route of administration and new pharmaceutical formulation of KEYTRUDA for use across all KEYTRUDA indications for adult patients in
Europe . -
FDA accepted two supplemental Biologics License Applications (sBLAs) for KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of certain patients with PD-L1+ inoperable (unresectable) locally advanced or metastatic TNBC based on Phase 3 KEYNOTE-D19/ASCENT-04 trial.
- FDA set Prescription Drug User Fee Act (PDUFA) dates in the second half of 2026 for these applications.
- Announced positive topline results from Phase 3 KEYNOTE-B15 trial in patients with MIBC who are eligible for cisplatin-based chemotherapy showing KEYTRUDA plus Padcev significantly improved event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates versus neoadjuvant chemotherapy and surgery when given before and after surgery.
-
In collaboration with Moderna, Inc. (Moderna), announced median five-year follow-up data from Phase 2b KEYNOTE-942/mRNA-4157-P201 study for intismeran autogene, an investigational mRNA-based individualized neoantigen therapy, in combination with KEYTRUDA in patients with high-risk melanoma (stage III/IV) following complete resection.
-
-
Infectious Diseases:
-
Announced positive topline results from the Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of adults with HIV-1 infection who had not previously received antiretroviral treatment (treatment-naïve).
-
Announced positive topline results from the Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of adults with HIV-1 infection who had not previously received antiretroviral treatment (treatment-naïve).
-
Cardiometabolic and Respiratory:
-
Presented new data at the American Heart Association Scientific Sessions 2025, including results from the Phase 3 CORALreef Lipids and heterozygous familial hypercholesterolemia (HeFH) trials, demonstrating that enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hypercholesterolemia, significantly reduced low-density lipoprotein cholesterol (LDL-C) with a safety profile comparable to placebo.
- FDA awarded a priority review voucher under the CNPV pilot program for enlicitide decanoate.
- In January 2026, EC approved an expanded indication for WINREVAIR, in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH (Group 1 pulmonary hypertension) in adult patients with World Health Organization (WHO) Functional Class II, III and IV based on Phase 3 ZENITH trial.
-
In February 2026, FDA accepted a new sBLA for WINREVAIR seeking approval to update the
U.S. product label based on Phase 3 HYPERION trial.- FDA set PDUFA date of September 21, 2026.
-
Announced that Phase 2, proof-of-concept CADENCE study evaluating WINREVAIR in adults for the treatment of combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF) met its primary endpoint.
-
Presented new data at the American Heart Association Scientific Sessions 2025, including results from the Phase 3 CORALreef Lipids and heterozygous familial hypercholesterolemia (HeFH) trials, demonstrating that enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hypercholesterolemia, significantly reduced low-density lipoprotein cholesterol (LDL-C) with a safety profile comparable to placebo.
-
Business Development:
-
In 2026, completed acquisition of Cidara Therapeutics, Inc. (Cidara) for a total transaction value of approximately
.$9.2 billion - Added MK-1406 (formerly CD388), an investigational long-acting, strain-agnostic antiviral agent designed to prevent influenza infection in individuals at higher risk of complications, to the Company’s portfolio.
- MK-1406 is currently being evaluated in the Phase 3 ANCHOR study.
- Entered into strategic financing agreement with Blackstone Life Sciences to partially fund the development of sac-TMT in 2026.
- Entered into an agreement with Falk for certain development and commercialization rights to MK-8690, an investigational anti-CD30 ligand monoclonal antibody.
-
In 2026, completed acquisition of Cidara Therapeutics, Inc. (Cidara) for a total transaction value of approximately
Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.*
Oncology |
FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Perioperative Treatment for Adults With Cisplatin-Ineligible MIBC; Based on Results From Phase 3 KEYNOTE-905 Trial |
EC Approved Subcutaneous Administration of KEYTRUDA for All Adult Indications Approved in EU; Based on Results From Phase 3 3475A-D77 Trial |
|
KEYTRUDA Plus Padcev Significantly Improved EFS, OS and pCR Rates for Cisplatin-Eligible Patients With MIBC When Given Before and After Surgery; Based on Results From Phase 3 KEYNOTE-B15 Trial |
|
The Company and Moderna Announced 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA Demonstrated Sustained Improvement in the Primary Endpoint of Recurrence-Free Survival in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection; Based on Follow-up Analysis From Phase 2b KEYNOTE-942/mRNA-4157-P201 Trial |
|
The Company Initiated Phase 3 KANDLELIT-007 Trial Evaluating Calderasib (MK-1084), an Investigational Oral KRAS G12C Inhibitor, in Combination With KEYTRUDA QLEX in Certain Patients With Advanced NSCLC |
|
The Company Presented Data at the American Society of Hematology Annual Meeting 2025 That Showcased Continued Advancements in Hematology Pipeline and Novel Therapeutic Approaches |
|
Vaccines and Infectious Diseases |
The Company Announced Positive Topline Results From Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of DOR/ISL in Treatment-Naïve Adults With HIV-1 Infection |
Cardiometabolic and Respiratory |
Enlicitide Decanoate Significantly Reduced LDL-C in Phase 3 CORALreef Lipids Trial |
Enlicitide Decanoate Significantly Reduced LDL-C in Adults With HeFH in Phase 3 CORALreef HeFH Trial |
|
WINREVAIR Met Primary Endpoint in Phase 2, Proof-Of-Concept CADENCE Study in Adults With CpcPH Due to HFpEF |
|
Neuroscience |
The Company Showcased Data for Alzheimer’s Disease Candidates MK-2214 and MK-1167 at Clinical Trials on Alzheimer’s Disease 2025 |
Animal Health |
FDA Conditionally Approved EXZOLT CATTLE-CA1 for Prevention and Treatment of New World Screwworm (Cochliomyia Hominivorax) Larvae (Myiasis) |
*References to the Company’s name in the above news release titles have been modified for the purpose of this announcement. |
The Company reached an agreement with the
Under the agreement, among other things, the Company plans to provide key products through a direct-to-patient program at affordable prices for eligible patients in the
Full-Year 2026 Financial Outlook
The following table summarizes the Company’s full-year financial outlook.
|
Full Year 2026 |
Sales* |
|
Non-GAAP Gross margin2 |
Approximately |
Non-GAAP Operating expenses2** |
|
Non-GAAP Other (income) expense, net2 |
Approximately |
Non-GAAP Effective tax rate2 |
|
Non-GAAP EPS2*** |
|
Share count (assuming dilution) |
Approximately 2.48 billion |
*The Company does not have any non-GAAP adjustments to sales. |
**Includes a one-time charge of approximately |
***Includes a one-time charge of approximately |
The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results.
The Company anticipates full-year 2026 sales to be between
The Company’s full-year non-GAAP effective income tax rate is expected to be between
The Company expects full-year 2026 non-GAAP EPS to be between
Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.
Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, as well as income and losses from investments in equity securities.
Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, Feb. 3, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website.
All participants may join the call by dialing (800) 369-3351 (
About Our Company
At Merck & Co., Inc.,
Forward-Looking Statement of Merck & Co., Inc.,
This news release of Merck & Co., Inc.,
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in
The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Appendix
Generic product names are provided below.
Pharmaceutical
BRIDION (sugammadex)
CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine)
ENFLONSIA (clesrovimab-cfor)
GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant)
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
JANUMET (sitagliptin and metformin HCl)
JANUVIA (sitagliptin)
KEYTRUDA (pembrolizumab)
KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)
LAGEVRIO (molnupiravir)
Lenvima (lenvatinib)
Lynparza (olaparib)
M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)
OHTUVAYRE (ensifentrine)
PREVYMIS (letermovir)
PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
Reblozyl (luspatercept-aamt)
ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent)
Simponi (golimumab)
VARIVAX (Varicella Virus Vaccine Live)
VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)
WELIREG (belzutifan)
WINREVAIR (sotatercept-csrk)
Animal Health
BRAVECTO (fluralaner)
____________________ |
1 Net income attributable to the Company. |
2 The Company is providing certain 2025 and 2024 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the Company’s results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release. |
3 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations, licensing arrangements and asset acquisitions, and recognition of fair value step-up to inventories for asset acquisitions. |
4 Includes the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments for all periods presented. Amount in the full year of 2025 also includes a |
| MERCK & CO., INC., |
||||||||||||||||||
| CONSOLIDATED STATEMENT OF INCOME - GAAP | ||||||||||||||||||
| (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) | ||||||||||||||||||
| (UNAUDITED) | ||||||||||||||||||
| Table 1 | ||||||||||||||||||
|
||||||||||||||||||
|
GAAP | % Change | GAAP | % Change | ||||||||||||||
|
||||||||||||||||||
|
|
4Q25 |
|
|
4Q24 |
|
Full Year 2025 | Full Year 2024 | ||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Sales |
|
$ |
16,400 |
|
$ |
15,624 |
|
|
$ |
65,011 |
|
$ |
64,168 |
|
|
|||
|
||||||||||||||||||
| Costs, Expenses and Other |
|
|||||||||||||||||
| Cost of sales |
|
|
5,551 |
|
|
3,828 |
|
|
|
16,382 |
|
|
15,193 |
|
|
|||
| Selling, general and administrative |
|
|
2,898 |
|
|
2,864 |
|
|
|
10,733 |
|
|
10,816 |
|
- |
|||
| Research and development |
|
|
3,886 |
|
|
4,585 |
|
- |
|
15,789 |
|
|
17,938 |
|
- |
|||
| Restructuring costs |
|
|
213 |
|
|
51 |
|
* |
|
889 |
|
|
309 |
|
* | |||
| Other (income) expense, net |
|
|
432 |
|
|
126 |
|
* |
|
151 |
|
|
(24 |
) |
* | |||
| Income Before Taxes |
|
|
3,420 |
|
|
4,170 |
|
- |
|
21,067 |
|
|
19,936 |
|
|
|||
| Income Tax Provision |
|
|
458 |
|
|
425 |
|
|
2,804 |
|
|
2,803 |
|
|||||
| Net Income |
|
|
2,962 |
|
|
3,745 |
|
- |
|
18,263 |
|
|
17,133 |
|
|
|||
| Less: Net (Loss) Income Attributable to Noncontrolling Interests |
|
|
(1 |
) |
|
2 |
|
|
9 |
|
|
16 |
|
|||||
| Net Income Attributable to Merck & Co., Inc., |
|
$ |
2,963 |
|
$ |
3,743 |
|
- |
$ |
18,254 |
|
$ |
17,117 |
|
|
|||
|
||||||||||||||||||
| Earnings per Common Share Assuming Dilution |
|
$ |
1.19 |
|
$ |
1.48 |
|
- |
$ |
7.28 |
|
$ |
6.74 |
|
|
|||
|
||||||||||||||||||
| Average Shares Outstanding Assuming Dilution |
|
|
2,488 |
|
|
2,537 |
|
|
2,507 |
|
|
2,541 |
|
|||||
| Tax Rate |
|
|
13.4 |
% |
|
10.2 |
% |
|
13.3 |
% |
|
14.1 |
% |
|||||
|
||||||||||||||||||
|
||||||||||||||||||
| * |
|
|||||||||||||||||
| MERCK & CO., INC., |
|||||||||||||||||||||||
| FOURTH QUARTER AND FULL YEAR 2025 GAAP TO NON-GAAP RECONCILIATION | |||||||||||||||||||||||
| (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) | |||||||||||||||||||||||
| (UNAUDITED) | |||||||||||||||||||||||
| Table 2a | |||||||||||||||||||||||
| GAAP | Acquisition- and Divestiture-Related Costs (1) | Restructuring Costs (2) | (Income) Loss from Investments in Equity Securities | Certain Other Items | Adjustment Subtotal | Non-GAAP | |||||||||||||||||
| Fourth Quarter | |||||||||||||||||||||||
| Cost of sales | $ |
5,551 |
|
1,054 |
|
1,173 |
|
2,227 |
|
$ |
3,324 |
|
|||||||||||
| Selling, general and administrative |
|
2,898 |
|
48 |
|
2 |
|
50 |
|
|
2,848 |
|
|||||||||||
| Research and development |
|
3,886 |
|
5 |
|
(111 |
) |
(106 |
) |
|
3,992 |
|
|||||||||||
| Restructuring costs |
|
213 |
|
213 |
|
213 |
|
|
– |
|
|||||||||||||
| Other (income) expense, net |
|
432 |
|
206 |
|
206 |
|
|
226 |
|
|||||||||||||
| Income Before Taxes |
|
3,420 |
|
(1,107 |
) |
(1,277 |
) |
(206 |
) |
(2,590 |
) |
|
6,010 |
|
|||||||||
| Income Tax Provision (Benefit) |
|
458 |
|
(187 |
) |
(3) |
(234 |
) |
(3) |
(44 |
) |
(3) |
|
(465 |
) |
|
923 |
|
|||||
| Net Income |
|
2,962 |
|
(920 |
) |
(1,043 |
) |
(162 |
) |
(2,125 |
) |
|
5,087 |
|
|||||||||
| Net Income Attributable to Merck & Co., Inc., |
|
2,963 |
|
(920 |
) |
(1,043 |
) |
(162 |
) |
(2,125 |
) |
|
5,088 |
|
|||||||||
| Earnings per Common Share Assuming Dilution | $ |
1.19 |
|
(0.37 |
) |
(0.42 |
) |
(0.06 |
) |
(0.85 |
) |
$ |
2.04 |
|
|||||||||
| Tax Rate |
|
13.4 |
% |
|
15.4 |
% |
|||||||||||||||||
| Full Year | |||||||||||||||||||||||
| Cost of sales | $ |
16,382 |
|
2,871 |
|
1,484 |
|
4,355 |
|
$ |
12,027 |
|
|||||||||||
| Selling, general and administrative |
|
10,733 |
|
120 |
|
3 |
|
123 |
|
|
10,610 |
|
|||||||||||
| Research and development |
|
15,789 |
|
19 |
|
175 |
|
194 |
|
|
15,595 |
|
|||||||||||
| Restructuring costs |
|
889 |
|
889 |
|
889 |
|
|
– |
|
|||||||||||||
| Other (income) expense, net |
|
151 |
|
(3 |
) |
(306 |
) |
(309 |
) |
|
460 |
|
|||||||||||
| Income Before Taxes |
|
21,067 |
|
(3,007 |
) |
(2,551 |
) |
306 |
|
(5,252 |
) |
|
26,319 |
|
|||||||||
| Income Tax Provision (Benefit) |
|
2,804 |
|
(525 |
) |
(3) |
(473 |
) |
(3) |
65 |
|
(3) |
(60 |
) |
(4) |
(993 |
) |
|
3,797 |
|
|||
| Net Income |
|
18,263 |
|
(2,482 |
) |
(2,078 |
) |
241 |
|
60 |
|
(4,259 |
) |
|
22,522 |
|
|||||||
| Net Income Attributable to Merck & Co., Inc., |
|
18,254 |
|
(2,482 |
) |
(2,078 |
) |
241 |
|
60 |
|
(4,259 |
) |
|
22,513 |
|
|||||||
| Earnings per Common Share Assuming Dilution | $ |
7.28 |
|
(0.99 |
) |
(0.83 |
) |
0.10 |
|
0.02 |
|
(1.70 |
) |
$ |
8.98 |
|
|||||||
| Tax Rate |
|
13.3 |
% |
|
14.4 |
% |
|||||||||||||||||
| Only the line items that are affected by non-GAAP adjustments are shown. | ||||||||||||||
| The Company is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors’ understanding of the Company’s results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. The non-GAAP information presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. | ||||||||||||||
| (1) Amounts included in cost of sales for the fourth quarter and full year reflect expenses for the amortization of intangible assets, as well as the recognition of fair value step-up of inventories related to the Verona Pharma acquisition. Cost of sales for the full year also includes intangible asset impairment charges. For the full year, cost of sales reflects a benefit from a decrease in the estimated fair value measurement of liabilities for contingent consideration. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. Amounts included in research and development expenses reflect the amortization of intangible assets. | ||||||||||||||
| (2) Amounts primarily include employee separation costs, accelerated depreciation and asset impairment charges associated with facilities to be closed or divested, as well as contractual termination costs and related adjustments, associated with activities under the Company's formal restructuring programs. | ||||||||||||||
| (3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments. | ||||||||||||||
| (4) Amount represents a net tax benefit, including a net benefit related to favorable audit reserve adjustments. |
| MERCK & CO., INC., |
|||||||||||||||||
| FRANCHISE / KEY PRODUCT SALES | |||||||||||||||||
| (AMOUNTS IN MILLIONS) | |||||||||||||||||
| (UNAUDITED) | |||||||||||||||||
| Table 3 | |||||||||||||||||
2025 |
2024 |
4Q |
Full Year |
||||||||||||||
| 1Q | 2Q | 3Q | 4Q | Full Year | 1Q | 2Q | 3Q | 4Q | Full Year | Nom % | Ex-Exch % | Nom % | Ex-Exch % | ||||
| TOTAL SALES (1) |
|
|
|
|
|
|
|
|
|
|
5 |
4 |
1 |
2 |
|||
| PHARMACEUTICAL | 13,638 |
14,050 |
15,611 |
14,843 |
58,142 |
14,006 |
14,408 |
14,943 |
14,042 |
57,400 |
6 |
4 |
1 |
1 |
|||
| Oncology | |||||||||||||||||
| Keytruda | 7,205 |
7,956 |
8,142 |
8,337 |
31,641 |
6,947 |
7,270 |
7,429 |
7,836 |
29,482 |
6 |
5 |
7 |
7 |
|||
| Keytruda Qlex | 5 |
35 |
40 |
- |
- |
- |
- |
||||||||||
| Alliance Revenue – Lynparza (2) | 312 |
370 |
379 |
389 |
1,450 |
292 |
317 |
337 |
365 |
1,311 |
7 |
4 |
11 |
10 |
|||
| Alliance Revenue – Lenvima (2) | 258 |
265 |
258 |
272 |
1,053 |
255 |
249 |
251 |
255 |
1,010 |
7 |
6 |
4 |
4 |
|||
| Welireg | 137 |
162 |
196 |
220 |
716 |
85 |
126 |
139 |
160 |
509 |
37 |
37 |
41 |
41 |
|||
| Alliance Revenue – Reblozyl (3) | 119 |
107 |
136 |
164 |
525 |
71 |
90 |
100 |
110 |
371 |
48 |
48 |
41 |
41 |
|||
| Vaccines (4) | |||||||||||||||||
| Gardasil/Gardasil 9 | 1,327 |
1,126 |
1,749 |
1,031 |
5,233 |
2,249 |
2,478 |
2,306 |
1,550 |
8,583 |
-34 |
-35 |
-39 |
-39 |
|||
| ProQuad/M-M-R II/Varivax | 539 |
609 |
684 |
619 |
2,451 |
570 |
617 |
703 |
594 |
2,485 |
4 |
3 |
-1 |
-2 |
|||
| Vaxneuvance | 230 |
229 |
226 |
140 |
825 |
219 |
189 |
239 |
161 |
808 |
-13 |
-16 |
2 |
1 |
|||
| Capvaxive | 107 |
129 |
244 |
279 |
759 |
47 |
50 |
97 |
* | * | * | * | |||||
| RotaTeq | 228 |
121 |
204 |
119 |
673 |
216 |
163 |
193 |
139 |
711 |
-14 |
-15 |
-5 |
-5 |
|||
| Pneumovax 23 | 41 |
38 |
45 |
42 |
166 |
61 |
59 |
68 |
74 |
263 |
-43 |
-44 |
-37 |
-37 |
|||
| Hospital Acute Care | |||||||||||||||||
| Bridion | 441 |
461 |
439 |
499 |
1,841 |
440 |
455 |
420 |
449 |
1,764 |
11 |
11 |
4 |
4 |
|||
| Prevymis | 208 |
228 |
266 |
275 |
978 |
174 |
188 |
208 |
215 |
785 |
28 |
26 |
25 |
23 |
|||
| Zerbaxa | 70 |
74 |
81 |
87 |
312 |
56 |
62 |
64 |
70 |
252 |
24 |
23 |
24 |
24 |
|||
| Dificid | 83 |
96 |
43 |
25 |
247 |
73 |
92 |
96 |
79 |
340 |
-68 |
-68 |
-27 |
-27 |
|||
| Cardiometabolic & Respiratory | |||||||||||||||||
| Winrevair | 280 |
336 |
360 |
467 |
1,443 |
70 |
149 |
200 |
419 |
133 |
133 |
* | * | ||||
| Alliance Revenue - Adempas/Verquvo (5) | 106 |
123 |
112 |
129 |
470 |
98 |
106 |
102 |
109 |
415 |
18 |
18 |
13 |
13 |
|||
| Adempas (6) | 68 |
80 |
82 |
83 |
312 |
70 |
72 |
72 |
73 |
287 |
14 |
9 |
9 |
6 |
|||
| Ohtuvayre | 178 |
178 |
- |
- |
- |
- |
|||||||||||
| Virology | |||||||||||||||||
| Lagevrio | 102 |
83 |
138 |
57 |
380 |
350 |
110 |
383 |
121 |
964 |
-53 |
-53 |
-61 |
-61 |
|||
| Isentress/Isentress HD | 90 |
86 |
82 |
67 |
325 |
111 |
89 |
102 |
92 |
394 |
-27 |
-28 |
-18 |
-18 |
|||
| Delstrigo | 67 |
83 |
77 |
79 |
306 |
56 |
60 |
65 |
69 |
249 |
15 |
9 |
23 |
20 |
|||
| Pifeltro | 45 |
41 |
43 |
42 |
171 |
42 |
39 |
42 |
40 |
163 |
6 |
4 |
5 |
4 |
|||
| Neuroscience | |||||||||||||||||
| Belsomra | 50 |
40 |
47 |
49 |
186 |
46 |
53 |
78 |
45 |
222 |
8 |
9 |
-16 |
-16 |
|||
| Immunology | |||||||||||||||||
| Simponi | 184 |
172 |
189 |
543 |
-100 |
-100 |
|||||||||||
| Remicade | 39 |
35 |
41 |
114 |
-100 |
-100 |
|||||||||||
| Diabetes (7) | |||||||||||||||||
| Januvia | 549 |
372 |
382 |
302 |
1,604 |
419 |
405 |
278 |
232 |
1,334 |
30 |
30 |
20 |
21 |
|||
| Janumet | 247 |
251 |
243 |
199 |
940 |
251 |
224 |
204 |
255 |
935 |
-22 |
-22 |
1 |
2 |
|||
| Other Pharmaceutical (8) | 729 |
584 |
948 |
658 |
2,917 |
632 |
618 |
638 |
699 |
2,590 |
-6 |
-5 |
13 |
13 |
|||
| ANIMAL HEALTH | 1,588 |
1,646 |
1,615 |
1,505 |
6,354 |
1,511 |
1,482 |
1,487 |
1,397 |
5,877 |
8 |
6 |
8 |
9 |
|||
| Livestock | 924 |
961 |
1,023 |
987 |
3,896 |
850 |
837 |
886 |
889 |
3,462 |
11 |
9 |
13 |
14 |
|||
| Companion Animal | 664 |
685 |
592 |
518 |
2,458 |
661 |
645 |
601 |
508 |
2,415 |
2 |
0 |
2 |
2 |
|||
| Other Revenues (9) | 303 |
110 |
50 |
52 |
515 |
258 |
222 |
227 |
185 |
891 |
-71 |
-15 |
-42 |
-6 |
|||
| * |
|||||||||||
| Sum of quarterly amounts may not equal year-to-date amounts due to rounding. | |||||||||||
| (1) Only select products are shown. | |||||||||||
| (2) Alliance Revenue represents the Company's share of profits, which are product sales net of cost of sales and commercialization costs. |
|||||||||||
| (3) Alliance Revenue represents royalties. | |||||||||||
| (4) Total Vaccines sales were |
|||||||||||
| (5) Alliance Revenue represents the Company's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs. | |||||||||||
| (6) Net product sales in the Company's marketing territories. | |||||||||||
| (7) Total Diabetes sales were |
|||||||||||
| (8) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of |
|||||||||||
| (9) Other Revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Other Revenues related to the receipt of upfront and milestone payments for out-licensed products were |
|||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20260203933145/en/
Media Contacts:
Michael Levey
michael.levey@msd.com
John Cummins
john.cummins2@msd.com
Investor Contacts:
Peter Dannenbaum
(732) 594-1579
Steven Graziano
(732) 594-1583
Source: Merck & Co., Inc.