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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of

The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) October 30, 2025 (October 30, 2025)

 

Merck & Co., Inc.

(Exact name of registrant as specified in its charter)

 

New Jersey

(State or other jurisdiction

of incorporation)

 

1-6571

(Commission

File Number)

 

22-1918501

(I.R.S. Employer

Identification No.)

 

126 East Lincoln Avenue, Rahway, NJ

(Address of principal executive offices)

 

07065

(Zip Code)

 

Registrant’s telephone number, including area code (908) 740-4000

 

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class  Trading Symbol(s)  Name of each exchange on which registered
Common Stock ($0.50 par value)  MRK  New York Stock Exchange
1.875% Notes due 2026  MRK/26  New York Stock Exchange
3.250% Notes due 2032  MRK/32  New York Stock Exchange
2.500% Notes due 2034  MRK/34  New York Stock Exchange
1.375% Notes due 2036  MRK 36A  New York Stock Exchange
3.500% Notes due 2037  MRK/37  New York Stock Exchange
3.700% Notes due 2044  MRK/44  New York Stock Exchange
3.750% Notes due 2054  MRK/54  New York Stock Exchange

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

The following information, including the exhibits hereto, is being furnished pursuant to this Item 2.02.

 

Incorporated by reference is a press release issued by Merck & Co., Inc. on October 30, 2025, regarding earnings for the third quarter of 2025, attached as Exhibit 99.1. Also incorporated by reference is certain supplemental information not included in the press release, attached as Exhibit 99.2.

 

This information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and is not incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

 

  (d) Exhibits
   
  Exhibit 99.1 Press release issued October 30, 2025, regarding earnings for the third quarter of 2025
   
  Exhibit 99.2 Certain supplemental information not included in the press release
   
  Exhibit 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    Merck & Co., Inc.
      
Date: October 30, 2025 By: /s/ Kelly E. W. Grez
    Kelly E. W. Grez
    Corporate Secretary

 

 

 

 

Exhibit 99.1

 

- 1 -

 

News Release
   

 

Merck & Co., Inc., Rahway, N.J., USA Announces Third-Quarter 2025 Financial Results

 

-Total Worldwide Sales Were $17.3 Billion, an Increase of 4% From Third Quarter 2024; Excluding the Impact of Foreign Exchange, Sales Grew 3%
oKEYTRUDA Sales Grew 10% to $8.1 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 8%
oWINREVAIR Sales Were $360 Million; Growth of 141% Both Nominally and Excluding the Impact of Foreign Exchange
oCAPVAXIVE Sales Were $244 Million
oGARDASIL/GARDASIL 9 Sales Declined 24% to $1.7 Billion; Excluding the Impact of Foreign Exchange, Sales Declined 25%
oAnimal Health Sales Grew 9% to $1.6 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 7%
-GAAP EPS Was $2.32; Non-GAAP EPS Was $2.58; GAAP and Non-GAAP EPS Include a Charge of $0.10 per Share for Milestone Payment to LaNova for Technology Transfer for MK-2010
-Received FDA Approval of KEYTRUDA QLEX Injection for Subcutaneous Use Across All Solid Tumor Indications for KEYTRUDA
-Presented New Research Across More Than 20 Types of Cancer and Multiple Treatment Settings at ESMO Congress 2025, Including Positive Survival Data From KEYNOTE-905 and KEYNOTE-B96
-Announced Positive Topline Results From Third Phase 3 CORALreef Lipids Trial of Enlicitide Decanoate for Treatment of Adults With Hypercholesterolemia
-Completed Acquisition of Verona Pharma and Its First-In-Class COPD Maintenance Treatment for Adults, OHTUVAYRE, in October
-Full-Year 2025 Financial Outlook
oNow Expects Worldwide Sales To Be Between $64.5 Billion and $65.0 Billion
oRaises and Narrows Expected Non-GAAP EPS Range To Be Between $8.93 and $8.98

 

RAHWAY, N.J., Oct. 30, 2025 – Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2025.

 

“In the third quarter, we continued to execute on our strategy with important pipeline advancements, significant approvals and successful new product launches,” said Robert M. Davis, chairman and chief executive officer. “We’re delivering value to patients and customers through our innovative portfolio of medicines and vaccines, and we’re securing our future by making important investments in our pipeline – including through compelling, strategic business development like our completed acquisition of Verona Pharma and expanded U.S. manufacturing and R&D spending. With each milestone we achieve, my conviction that we’re well-positioned to drive the next chapter of success for our Company increases.”

 

 

- 2 -

 

Financial Summary

 

    Third Quarter  
$ in millions, except EPS amounts    2025      2024      Change     Change
Ex-Exchange
 
Sales   $ 17,276     $ 16,657       4 %     3 %
GAAP net income1     5,785       3,157       83 %     84 %
Non-GAAP net income that excludes certain items1,2*     6,448       3,985       62 %     62 %
GAAP EPS     2.32       1.24       87 %     88 %
Non-GAAP EPS that excludes certain items2*     2.58       1.57       64 %     65 %

 

*Refer to table on page 7.

 

For the third quarter of 2025, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $2.32 and non-GAAP EPS was $2.58. GAAP and non-GAAP EPS in the third quarter of 2025 include a charge of $0.10 per share for a milestone payment to LaNova Medicines Ltd. (LaNova, acquired by Sino Biopharmaceutical Limited) associated with the technology transfer for MK-2010. GAAP and non-GAAP EPS in the third quarter of 2024 include a net charge of $0.79 per share in the aggregate for the acquisition of Eyebiotech Limited (EyeBio) and a related development milestone, the acquisition of MK-1045 from Curon Biopharmaceutical (Curon), as well as a payment received from Daiichi Sankyo related to the expansion of the existing development and commercialization agreement to include gocatamig (MK-6070).

 

Non-GAAP EPS in both periods excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in the third quarter of 2025 also excludes tax expense relating to audit reserve adjustments.

 

Year-to-date results can be found in the attached tables.

 

 

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 -

 

Third-Quarter Sales Performance

 

The following table reflects sales of the Company’s top products and significant performance drivers.

 

    Third Quarter  
$ in millions   2025     2024     Change     Change
Ex-Exchange
     Commentary
Total Sales   $ 17,276     $ 16,657       4 %     3 %    
Pharmaceutical     15,611       14,943       4 %     3 %   Increase primarily driven by growth in oncology, cardiovascular and diabetes, partially offset by declines in vaccines, virology and immunology.
KEYTRUDA     8,142       7,429       10 %     8 %   Growth driven by continued strong global demand from metastatic indications, including urothelial, endometrial and gastric cancers, as well as robust global uptake in earlier-stage indications including triple-negative breast cancer, cervical cancer, renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC). Sales also benefitted from timing of wholesaler purchases in the U.S., partially offset by other channel movements.
GARDASIL/GARDASIL 9     1,749       2,306       -24 %     -25 %   Decline primarily due to lower demand in China. Excluding China, sales declined 2%, or 3% excluding impact of foreign exchange, reflecting lower demand in Japan following a national catch-up immunization program, partially offset by higher sales in the U.S. due to higher net pricing and favorable public-sector purchasing patterns.
PROQUAD, M-M-R II and VARIVAX     684       703       -3 %     -3 %   Decline primarily due to lower demand, partially offset by higher net pricing in the U.S.
JANUVIA/JANUMET     624       482       29 %     29 %   Growth driven by higher net pricing in the U.S., partially offset by lower demand in China as well as in most other international markets due to generic competition.
BRIDION     439       420       5 %     4 %   Growth primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition.
Lynparza*     379       337       12 %     12 %   Growth primarily due to higher demand in the U.S. and certain international markets.

 

 

- 4 -

 

    Third Quarter  
$ in millions   2025     2024     Change     Change
Ex-Exchange
     Commentary
WINREVAIR     360       149       141 %     141 %   Growth largely reflects continued uptake in the U.S., partially offset by timing of distributor purchases and lower net pricing in the U.S. largely due to Medicare Part D redesign.
PREVYMIS     266       208       28 %     25 %   Increase primarily due to higher demand in the U.S. and launch of new indications in certain international markets, partially offset by lower demand in China due to generic competition.
Lenvima*     258       251       3 %     2 %   Increase primarily due to higher sales in the U.S. reflecting higher demand, partially offset by lower net pricing.
CAPVAXIVE     244       47       N/M       N/M     Represents continued uptake since third-quarter 2024 launch in the U.S., as well as expected seasonal inventory build.
VAXNEUVANCE     226       239       -6 %     -7 %   Decline primarily due to lower demand in certain international markets, particularly in Japan due to competitive pressure, partially offset by higher demand in certain European markets.
WELIREG     196       139       42 %     41 %   Growth primarily driven by higher demand in the U.S. and continued launch uptake in certain European markets, partially offset by lower net pricing in the U.S.
LAGEVRIO     138       383       -64 %     -65 %   Decline primarily due to lower demand in the Asia Pacific region, particularly in Japan, as well as in the U.S.
SIMPONI     -       189       -100 %     -100 %   Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024.
Animal Health     1,615       1,487       9 %     7 %   Growth primarily due to performance of livestock products.
Livestock     1,023       886       16 %     14 %   Growth primarily driven by higher demand across all species, as well as timing of sales.
Companion Animal     592       601       -2 %     -3 %   Decline primarily due to lower demand, reflecting a reduction in veterinary visits and competitive pressure for parasiticides, partially offset by higher pricing, improved supply and new product launches. Sales of BRAVECTO were $262 million and $266 million in current and prior-year quarters, respectively, which represents a decline of 1%, or 3% excluding impact of foreign exchange.
Other Revenues**     50       227       -78 %     -27 %   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.

 

- 5 -

 

In addition, Koselugo alliance revenue was $214 million in the third quarter of 2025 compared with $39 million in the third quarter of 2024. The increase was due to an amendment to the collaboration agreement with AstraZeneca, which discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure, resulting in the Company’s recognition of a $150 million upfront payment and a $50 million regulatory milestone.

 

Third-Quarter Expense, EPS and Related Information

 

The table below presents selected expense information.

 

$ in millions    GAAP      Acquisition-
and Divestiture-
Related Costs3
     Restructuring
Costs
    (Income)
Loss From
Investments
in Equity
Securities
     Non-GAAP2  
Third Quarter 2025                                        
Cost of sales   $ 3,855     $ 621     $ 110     $ -     $ 3,124  
Selling, general and administrative     2,633       34       -       -       2,599  
Research and development     4,234       4       233       -       3,997  
Restructuring costs     47       -       47       -       -  
Other (income) expense, net     (238 )     -       -       (344 )     106  
                                         
Third Quarter 2024                                        
Cost of sales   $ 4,080     $ 639     $ 192     $ -     $ 3,249  
Selling, general and administrative     2,731       43       31       -       2,657  
Research and development     5,862       24       -       -       5,838  
Restructuring costs     56       -       56       -       -  
Other (income) expense, net     (162 )     (27 )     -       58       (193 )

 

GAAP Expense, EPS and Related Information

 

Gross margin was 77.7% for the third quarter of 2025 compared with 75.5% for the third quarter of 2024. The increase was primarily due to the favorable impact of product mix and lower restructuring costs, partially offset by higher inventory write-offs and the unfavorable impact of foreign exchange.

 

Selling, general and administrative (SG&A) expenses were $2.6 billion in the third quarter of 2025, a decrease of 4% compared with the third quarter of 2024. The decrease was primarily due to lower administrative, restructuring and selling costs, partially offset by the unfavorable impact of foreign exchange.

 

Research and development (R&D) expenses were $4.2 billion in the third quarter of 2025, a decrease of 28% compared with the third quarter of 2024. The decrease was primarily due to lower charges for business development activity, including charges of $2.2 billion in the aggregate related to the acquisitions of EyeBio and MK-1045 in the third quarter of 2024, compared with a charge of $300 million in the third quarter of 2025 related to a milestone payment to LaNova for the completion of the technology transfer for MK-2010. Excluding these charges, R&D expenses increased primarily due to higher restructuring costs and clinical development spending.

 

 

3 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations and licensing arrangements.

 

 

- 6 -

 

Other (income) expense, net, was $238 million of income in the third quarter of 2025 compared with $162 million of income in the third quarter of 2024. The favorability was primarily due to net income from investments in equity securities in 2025 compared with net losses from investments in equity securities in 2024, partially offset by $170 million of income recognized in 2024 related to a payment received from Daiichi Sankyo associated with the expansion of an existing development and commercialization agreement to include gocatamig (MK-6070).

 

The effective tax rate was 14.2% for the third quarter of 2025.

 

GAAP EPS was $2.32 for the third quarter of 2025 compared with $1.24 for the third quarter of 2024. The increase was primarily driven by a net charge of $0.79 per share in the aggregate in 2024 for the EyeBio, Curon and Daiichi Sankyo transactions, partially offset by a charge of $0.10 per share in 2025 related to the LaNova technology transfer milestone payment.

 

Non-GAAP Expense, EPS and Related Information

 

Non-GAAP gross margin was 81.9% for the third quarter of 2025 compared with 80.5% for the third quarter of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by higher inventory write-offs and the unfavorable impact of foreign exchange.

 

Non-GAAP SG&A expenses were $2.6 billion in the third quarter of 2025, a decrease of 2% compared with the third quarter of 2024. The decrease was primarily due to lower administrative and selling costs, partially offset by the unfavorable impact of foreign exchange.

 

Non-GAAP R&D expenses were $4.0 billion in the third quarter of 2025, a decrease of 32% compared with the third quarter of 2024. The decrease was primarily due to lower charges for business development activity, including charges of $2.2 billion in the aggregate related to the acquisitions of EyeBio and MK-1045 in the third quarter of 2024, compared with a charge of $300 million in the third quarter of 2025 related to a milestone payment to LaNova for the completion of the technology transfer for MK-2010. Excluding these charges, R&D expenses increased primarily due to higher clinical development spending.

 

Non-GAAP other (income) expense, net, was $106 million of expense in the third quarter of 2025 compared with $193 million of income in the third quarter of 2024. The unfavorability was primarily due to $170 million of income recognized in 2024 related to a payment received from Daiichi Sankyo associated with the expansion of an existing development and commercialization agreement to include gocatamig (MK-6070).

 

 

- 7 -

 

The non-GAAP effective tax rate was 13.4% for the third quarter of 2025.

 

Non-GAAP EPS was $2.58 for the third quarter of 2025 compared with $1.57 for the third quarter of 2024. The increase was primarily driven by a net charge of $0.79 per share in the aggregate in 2024 for the EyeBio, Curon and Daiichi Sankyo transactions, partially offset by a charge of $0.10 per share in 2025 related to the LaNova technology transfer milestone payment.

 

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.

 

   Third Quarter 
$ in millions, except EPS amounts  2025   2024 
EPS          
GAAP EPS  $2.32   $1.24 
Difference   0.26    0.33 
Non-GAAP EPS that excludes items listed below2  $2.58   $1.57 
           
Net Income          
GAAP net income1  $5,785   $3,157 
Difference   663    828 
Non-GAAP net income that excludes items listed below1,2  $6,448   $3,985 
           
Excluded Items:          
   Acquisition- and divestiture-related costs3  $659   $679 
   Restructuring costs   390    279 
   (Income) loss from investments in equity securities   (344)   58 
Decrease to net income before taxes   705    1,016 
Estimated income tax (benefit) expense4   (42)   (188)
Decrease to net income  $663   $828 

 

 

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 both periods presented. Amount in the third quarter of 2025 also includes $86 million of tax expense relating to audit reserve adjustments.

 

 

- 8 -

 

Pipeline and Portfolio Highlights

 

In the third quarter, the Company continued to demonstrate pipeline progress with the achievement of key regulatory and clinical milestones.

 

In oncology, in September 2025, the U.S. Food and Drug Administration (FDA) approved KEYTRUDA QLEX injection for subcutaneous (SC) administration for use in adults across most solid tumor indications for KEYTRUDA, based on results from the Phase 3 MK-3475A-D77 trial. In October 2025, the FDA subsequently approved KEYTRUDA QLEX for the treatment of certain adult patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC), based on results from the Phase 3 KEYNOTE-689 trial. KEYTRUDA QLEX is now approved for use in adults across all solid tumor indications approved for KEYTRUDA and is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute.

 

In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval for SC administration of KEYTRUDA for all adult indications; a final decision is expected in the fourth quarter of 2025. The European Commission (EC) also approved KEYTRUDA as part of a perioperative regimen for the treatment of PD-L1+ resectable LA-HNSCC.

 

At the European Society for Medical Oncology (ESMO) Congress 2025, the Company announced new research from its broad and differentiated portfolio and pipeline, highlighting progress in new tumor types and earlier stages of disease. This included positive results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC), the Phase 3 KEYNOTE-B96 trial in platinum-resistant recurrent ovarian cancer and the Phase 2/3 REJOICE-Ovarian01 trial in collaboration with Daiichi Sankyo in certain types of platinum-resistant ovarian cancer, long-term follow-up data from the Phase 3 KEYNOTE-775 trial in advanced endometrial cancer, as well as long-term data for KEYTRUDA in both earlier-stage and metastatic NSCLC.

 

In vaccines and infectious diseases, in August 2025, the Company received two approvals in Japan: its nine-valent HPV vaccine for use in males ages 9 and older that will be marketed under the trademark SILGARD 9, and CAPVAXIVE for use in the elderly or adults who are at an increased risk of pneumococcal disease.

 

At the European AIDS Clinical Society 2025 conference, the Company also presented new data from Phase 3 trials evaluating the once-daily, oral, two-drug regimen of doravirine/islatravir in adults with virologically suppressed HIV-1 infection, which showed minimal changes in weight and body composition and no clinically meaningful effect on fasting lipids and the homeostatic model assessment of insulin resistance across both clinical trials.

 

In cardiovascular disease, the Company announced positive topline results from the Phase 3 CORALreef Lipids trial evaluating the safety and efficacy of enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hypercholesterolemia. The trial met all primary and key secondary endpoints. Enlicitide has the potential to be the first approved oral PCSK9 inhibitor.

 

 

- 9 -

 

 

In addition, the FDA approved an update to the U.S. product label for WINREVAIR, based on results from the Phase 3 ZENITH trial, expanding the indication to include components of the clinical worsening events: hospitalization for pulmonary arterial hypertension (PAH), lung transplantation and death. Further, at the 2025 European Respiratory Society Congress, the Company presented positive results from the Phase 3 HYPERION trial evaluating WINREVAIR versus placebo (both in combination with background therapy) in adults recently diagnosed with PAH (Group 1 pulmonary hypertension) with World Health Organization (WHO) functional class II or III at intermediate or high risk of disease progression. Results showed that adding WINREVAIR within the first year after PAH diagnosis significantly reduced the risk of clinical worsening events compared to placebo.

 

The Company also completed its acquisition of Verona Pharma plc (Verona Pharma) in October 2025, strengthening its cardio-pulmonary portfolio with the addition of OHTUVAYRE, an FDA-approved, first-in-class maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients.

 

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 QLEX Injection for SC Use in Adults Across Most Solid Tumor Indications for KEYTRUDA; Based on Results From Phase 3 MK-3475A-D77 Trial
FDA Granted Breakthrough Therapy Designation for Raludotatug Deruxtecan (R-DXd) for Patients With CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Previously Treated With Bevacizumab; Based on Results From Phase 1 Trial and REJOICE-Ovarian01 Phase 2/3 Trial
FDA Granted Breakthrough Therapy Designation for Ifinatamab Deruxtecan (I-DXd) for Patients With Pretreated Extensive-Stage Small Cell Lung Cancer; Based on Results From Phase 2 IDeate-Lung01 Trial
FDA Granted Priority Review for KEYTRUDA and KEYTRUDA QLEX, Each in Combination With Padcev, for Certain Patients With MIBC; FDA Set Prescription Drug User Fee Act (PDUFA) Date of April 7, 2026
EC Approved KEYTRUDA as Part of a Treatment Regimen for Adults With Resectable LA-HNSCC Expressing PD-L1 (CPS≥1); Based on Results From Phase 3 KEYNOTE-689 Trial
EU CHMP Adopted Two Positive Opinions for KEYTRUDA, for SC Administration and for New Indication for Earlier-Stage Head and Neck Cancer; Latter Based on Results From Phase 3 KEYNOTE-689 Trial
KEYTRUDA Plus Padcev Reduced Risk of Event-Free Survival Events by 60% and Risk of Death by 50% for Certain Patients With MIBC When Given Before and After Surgery; Based on Results From Phase 3 KEYNOTE-905 Trial
KEYTRUDA Plus Chemotherapy, With or Without Bevacizumab, Reduced Risk of Disease Progression or Death Versus Chemotherapy, With or Without Bevacizumab, in Certain Patients With Platinum-Resistant Recurrent Ovarian Cancer; Based on Results From Phase 3 KEYNOTE-B96 Trial; FDA Set PDUFA Date of Feb. 20, 2026
Phase 3 KEYNOTE-B96 Trial Met Secondary Endpoint of Overall Survival in All Comers Population of Patients With Platinum-Resistant Recurrent Ovarian Cancer
R-DXd Demonstrated Clinically Meaningful Response Rates in Patients With Recurrent Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer in Phase 2 Part of REJOICE-Ovarian01 Phase 2/3 Trial
KEYTRUDA Demonstrated Long-Term Survival Benefit in Certain Patients With Earlier or Advanced Stages of NSCLC; Based on Exploratory Five-Year Analyses of Phase 3 KEYNOTE-671 Trial, Eight-Year Analyses of Phase 3 KEYNOTE-024 and KEYNOTE-042 Trials, and 10-Year Analyses of Phase 1b KEYNOTE-001 and Phase 2/3 KEYNOTE-010 Trials
KEYTRUDA Plus Lenvima Demonstrated Durable Five-Year Survival Benefit Versus Chemotherapy for Patients With Advanced Endometrial Carcinoma Following One Prior Platinum-Based Regimen; Based on Results From Phase 3 KEYNOTE-775 Trial
WELIREG Plus Lenvima Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced RCC; Based on Results From Phase 3 LITESPARK-011 Trial
KEYTRUDA Plus WELIREG Met Primary Endpoint of Disease-Free Survival in Certain Patients With Clear Cell RCC Following Nephrectomy; Based on Results From Phase 3 LITESPARK-022 Trial  
I-DXd Demonstrated Clinically Meaningful Response Rates in Patients With Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial
HERTHENA-Breast04 Phase 3 Trial of Patritumab Deruxtecan (HER3-DXd) Initiated in Patients With Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Previously Treated With Endocrine Therapy

 

 

- 10 -

 

Vaccines and Infectious Diseases CAPVAXIVE Demonstrated Positive Immune Responses in Children and Adolescents at Increased Risk of Pneumococcal Disease; Based on Results From Phase 3 STRIDE-13 Trial
The Company Announced New Data From Phase 3 Trials Evaluating the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir in Adults With Suppressed HIV-1 Infection; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials
Systematic Review of 15 Studies Focused on Epidemiology and Antimicrobial Resistance of Pneumococcal Serotypes Covered by CAPVAXIVE in U.S. Adults
Cardiovascular FDA Approved Updated Indication for WINREVAIR in Adults With PAH Based on Phase 3 ZENITH Study
WINREVAIR Reduced the Risk of Clinical Worsening Events by 76% Compared to Placebo in Patients Recently Diagnosed With PAH on Background Therapy in Phase 3 HYPERION Trial
Oral PCSK9 Inhibitor Enlicitide Decanoate Met All Primary and Key Secondary Endpoints in Adults With Hypercholesterolemia in Pivotal Phase 3 CORALreef Lipids Study
Immunology The Company Expanded Tulisokibart Clinical Development Program With Initiation of Phase 2b Trials in Three Additional Immune-Mediated Inflammatory Diseases

 

*References to the Company’s name in the above news release titles have been modified for the purpose of this announcement.

 

Manufacturing and R&D Investment

 

The Company continued to make long-term investments in its U.S. manufacturing and R&D capabilities and broke ground on a new $3 billion Center of Excellence for Pharmaceutical Manufacturing at its Elkton, Virginia site. The 400,000-square-foot facility will include both active pharmaceutical ingredient and drug product investment to support small molecule manufacturing and testing, creating more than 500 full-time jobs. This investment is part of the Company’s commitment to dedicate more than $70 billion beginning in 2025 to expand domestic manufacturing and R&D — not including any future business development in R&D — to drive its long-term growth and strengthen the U.S. as a global leader in biopharmaceutical innovation.

 

Upcoming Investor Event

 

The Company also plans to present new data from its innovative cardiovascular pipeline and portfolio at the American Heart Association (AHA) Scientific Sessions 2025 from Nov. 7-10. The Company will host an Investor Event to coincide with the AHA Scientific Sessions 2025 on Sunday, Nov. 9 at 6 p.m. CT. The event will take place in New Orleans and will be accessible via live audio webcast at this weblink.

 

 

- 11 -

 

Sustainability Highlights

 

The Company’s 2024/2025 Purpose for Progress Impact Report provided a comprehensive view of how it is pursuing innovative science for the health of people and animals and ensuring its efforts drive significant and sustainable value. The report noted that the Company’s medicines and vaccines reached more than 450 million people around the world in 2024.

 

Full-Year 2025 Financial Outlook

 

The following table summarizes the Company’s full-year financial outlook.

 

   Full Year 2025
   Updated  Prior
Sales*  $64.5 billion to $65.0 billion  $64.3 billion to $65.3 billion
Non-GAAP Gross margin2  Approximately 82%  Approximately 82%
Non-GAAP Operating expenses2(a)  $25.9 billion to $26.4 billion  $25.6 billion to $26.4 billion
Non-GAAP Other (income) expenses, net2   $400 million to $500 million expense  $300 million to $400 million expense
Non-GAAP Effective tax rate2  14.0% to 15.0%  15.0% to 16.0%
Non-GAAP EPS2(b)(c)  $8.93 to $8.98  $8.87 to $8.97
Share count (assuming dilution)  Approximately 2.51 billion  Approximately 2.51 billion

 

*The Company does not have any non-GAAP adjustments to sales.

(a)Includes one-time R&D charges of $300 million for a milestone payment to LaNova associated with the technology transfer for MK-2010 and $200 million for an upfront payment for a license agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma). Outlook does not assume any additional significant potential business development transactions.

(b)Includes one-time charges totaling $0.16 per share associated with the payment for the LaNova technology transfer for MK-2010 and the upfront payment to Hengrui Pharma.

(c)Updated full-year 2025 outlook reflects a benefit of approximately $0.09 per share resulting from an amendment to the collaboration agreement with AstraZeneca related to Koselugo, and an estimated negative impact of $0.04 per share related to the acquisition of Verona Pharma.

 

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 now expects full-year 2025 sales to be between $64.5 billion and $65.0 billion, including a negative impact of foreign exchange of approximately 0.5% at mid-October 2025 exchange rates.

 

The Company now expects its full-year non-GAAP effective income tax rate to be between 14.0% and 15.0%.

 

 

- 12 -

 

The Company now expects its full-year non-GAAP EPS to be between $8.93 and $8.98, including a negative impact of foreign exchange of approximately $0.15 per share. This revised non-GAAP EPS outlook reflects several items not previously included, such as a benefit from an amended collaboration agreement with AstraZeneca related to Koselugo, and operational improvements, including a more favorable estimated tax rate and lower estimated costs related to the impact of tariffs, partially offset by an estimated negative impact related to the acquisition of Verona Pharma and an incremental negative impact from foreign exchange. The midpoint of this revised non-GAAP EPS range reflects a net improvement of $0.04 per share compared to the midpoint of the Company’s prior outlook.

 

As previously communicated, the revised estimated full-year 2025 non-GAAP EPS range reflects the impacts of the one-time charges in connection with a license agreement with Hengrui Pharma and the completion of the technology transfer with LaNova for MK-2010, which impact EPS by approximately $0.16 in the aggregate. In 2024, non-GAAP EPS of $7.65 was negatively impacted by a net charge of $1.28 per share related to certain asset acquisitions, licensing agreements and collaborations.

 

Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.

 

Earnings Conference Call

 

Investors, journalists and the general public may access a live audio webcast of the call on Thursday, Oct. 30, 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 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590. 

 

About Our Company

 

At Merck & Co., Inc., Rahway, N.J., USA, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

 

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

 

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “Company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

 

- 13 -

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 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)
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)
Koselugo (selumetinib)

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)

 

 

- 14 -

 

SIMPONI (golimumab)
VARIVAX (Varicella Virus Vaccine Live)
VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine

WELIREG (belzutifan

WINREVAIR (sotatercept-csrk)

 

Animal Health

BRAVECTO (fluralaner)

 

###

 

 

Media Contacts: Investor Contacts:

 

Michael Levey

[email protected]

 

John Cummins

[email protected]

 

 

Peter Dannenbaum

(732) 594-1579

 

Steven Graziano

(732) 594-1583

 

 

 

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA

CONSOLIDATED STATEMENT OF INCOME - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1

 

    GAAP         GAAP      
    3Q25    3Q24    % Change    Sep YTD
2025
    Sep YTD
2024
    % Change 
Sales  $17,276   $16,657    4%  $48,611   $48,544    0%
                               
Costs, Expenses and Other                              
Cost of sales   3,855    4,080    -6%   10,831    11,365    -5%
Selling, general and administrative   2,633    2,731    -4%   7,835    7,952    -1%
Research and development   4,234    5,862    -28%   11,903    13,354    -11%
Restructuring costs   47    56    -16%   676    258    *  
Other (income) expense, net   (238)   (162)   47%   (281)   (151)   86%
Income Before Taxes   6,745    4,090    65%   17,647    15,766    12%
Income Tax Provision   958    929         2,346    2,377      
Net Income   5,787    3,161    83%   15,301    13,389    14%
Less: Net Income Attributable to Noncontrolling Interests   2    4         10    15      
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA  $5,785   $3,157    83%  $15,291   $13,374    14%
                               
Earnings per Common Share Assuming Dilution  $2.32   $1.24    87%  $6.08   $5.26    16%
                               
Average Shares Outstanding Assuming Dilution   2,498    2,541         2,514    2,543      
Tax Rate   14.2%   22.7%        13.3%   15.1%     

 

* 100% or greater

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA

THREE AND NINE MONTHS ENDED SEPTEMBER 30, 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 
Third Quarter                            
Cost of sales  $3,855    621    110              731   $3,124 
Selling, general and administrative   2,633    34                   34    2,599 
Research and development   4,234    4    233              237    3,997 
Restructuring costs   47         47              47     
Other (income) expense, net   (238)             (344)        (344)   106 
Income Before Taxes   6,745    (659)   (390)   344         (705)   7,450 
Income Tax Provision (Benefit)   958    (119)(3)   (82)(3)   73(3)    86(4)    (42)   1,000 
Net Income   5,787    (540)   (308)   271    (86)   (663)   6,450 
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   5,785    (540)   (308)   271    (86)   (663)   6,448 
Earnings per Common Share Assuming Dilution  $2.32    (0.22)   (0.12)   0.11    (0.03)   (0.26)  $2.58 
                                    
Tax Rate   14.2%                            13.4%
                                    
Sep YTD                                   
Cost of sales  $10,831    1,817    311              2,128   $8,703 
Selling, general and administrative   7,835    72    1              73    7,762 
Research and development   11,903    14    286              300    11,603 
Restructuring costs   676         676              676     
Other (income) expense, net   (281)   (3)        (512)        (515)   234 
Income Before Taxes   17,647    (1,900)   (1,274)   512         (2,662)   20,309 
Income Tax Provision (Benefit)   2,346    (338)(3)   (239)(3)   109(3)    (60)(4)   (528)   2,874 
Net Income   15,301    (1,562)   (1,035)   403    60    (2,134)   17,435 
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   15,291    (1,562)   (1,035)   403    60    (2,134)   17,425 
Earnings per Common Share Assuming Dilution  $6.08    (0.62)   (0.41)   0.16    0.02    (0.85)  $6.93 
                                    
Tax Rate   13.3%                            14.2%

 

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 third quarter reflect expenses for the amortization of intangible assets. Amounts included in cost of sales for the nine-month period include the amortization of intangible assets and intangible asset impairment charges, partially offset by 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 impairments associated with facilities to be closed or divested, and contractual termination costs related to activities under the Company's formal restructuring programs.

 

(3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.

 

(4) Amount in the third quarter represents tax expense relating to audit reserve adjustments. Amount in the nine-month period represents a tax benefit, including a net benefit related to favorable audit reserve adjustments.

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA

FRANCHISE / KEY PRODUCT SALES

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3

 

  2025  2024  3Q  Sep YTD 
  1Q  2Q  3Q  Sep YTD  1Q  2Q  3Q  Sep YTD  4Q  Full Year  Nom %  Ex-Exch %  Nom %  Ex-Exch % 
TOTAL SALES (1)  $15,529  $15,806  $17,276  $48,611  $15,775  $16,112  $16,657  $48,544  $15,624  $64,168  4  3  0  1 
PHARMACEUTICAL  13,638   14,050   15,611   43,299   14,006   14,408   14,943   43,358   14,042   57,400  4  3  0  0 
Oncology                                                    
Keytruda  7,205   7,956   8,142   23,303   6,947   7,270   7,429   21,646   7,836   29,482  10  8  8  8 
Alliance Revenue – Lynparza (2)  312   370   379   1,061   292   317   337   947   365   1,311  12  12  12  12 
Alliance Revenue – Lenvima (2)  258   265   258   781   255   249   251   755   255   1,010  3  2  3  3 
Welireg  137   162   196   496   85   126   139   349   160   509  42  41  42  42 
Alliance Revenue – Reblozyl (3)  119   107   136   361   71   90   100   261   110   371  36  36  39  39 
Vaccines (4)                                                    
Gardasil/Gardasil 9  1,327   1,126   1,749   4,202   2,249   2,478   2,306   7,032   1,550   8,583  -24  -25  -40  -40 
ProQuad/M-M-R II/Varivax  539   609   684   1,832   570   617   703   1,891   594   2,485  -3  -3  -3  -3 
Vaxneuvance  230   229   226   685   219   189   239   647   161   808  -6  -7  6  6 
RotaTeq  228   121   204   554   216   163   193   572   139   711  6  5  -3  -3 
Capvaxive  107   129   244   480           47   47   50   97  *  *  *  * 
Pneumovax 23  41   38   45   124   61   59   68   188   74   263  -34  -35  -34  -34 
Hospital Acute Care                                                    
Bridion  441   461   439   1,341   440   455   420   1,315   449   1,764  5  4  2  2 
Prevymis  208   228   266   702   174   188   208   570   215   785  28  25  23  23 
Zerbaxa  70   74   81   225   56   62   64   182   70   252  25  24  24  24 
Dificid  83   96   43   222   73   92   96   261   79   340  -55  -55  -15  -15 
Cardiovascular                                                    
Winrevair  280   336   360   976       70   149   219   200   419  141  141  *  * 
Alliance Revenue - Adempas/Verquvo (5)  106   123   112   340   98   106   102   306   109   415  9  9  11  11 
Adempas (6)  68   80   82   229   70   72   72   214   73   287  14  7  7  5 
Virology                                                    
Lagevrio  102   83   138   323   350   110   383   843   121   964  -64  -65  -62  -62 
Isentress/Isentress HD  90   86   82   258   111   89   102   302   92   394  -20  -21  -15  -14 
Delstrigo  67   83   77   228   56   60   65   180   69   249  19  13  26  24 
Pifeltro  45   41   43   128   42   39   42   123   40   163  1  -1  4  4 
Neuroscience                                                    
Belsomra  50   40   47   137   46   53   78   177   45   222  -40  -40  -23  -22 
Immunology                                                    
Simponi                  184   172   189   545       543  -100  -100  -100  -100 
Remicade                  39   35   41   115       114  -100  -100  -100  -100 
Diabetes (7)                                                    
Januvia  549   372   382   1,302   419   405   278   1,102   232   1,334  37  37  18  19 
Janumet  247   251   243   741   251   224   204   679   255   935  19  20  9  11 
Other Pharmaceutical (8)  729   584   953   2,268   632   618   638   1,890   699   2,590  50  49  20  21 
ANIMAL HEALTH  1,588   1,646   1,615   4,849   1,511   1,482   1,487   4,480   1,397   5,877  9  7  8  10 
Livestock  924   961   1,023   2,909   850   837   886   2,573   889   3,462  16  14  13  15 
Companion Animal  664   685   592   1,940   661   645   601   1,907   508   2,415  -2  -3  2  2 
Other Revenues (9)  303   110   50   463   258   222   227   706   185   891  -78  -27  -34  -4 

 

*200% or greater  

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 $2,607 million, $2,370 million and $3,370 million in the first, second and third quarter of 2025, respectively, and $3,424 million, $3,656 million and $3,675 million in the first, second and third quarter of 2024, respectively.

 

(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 $876 million, $704 million and $703 million in the first, second and third quarter of 2025, respectively, and $745 million, $715 million and $592 million in the first, second and third quarter of 2024.

 

(8) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $44 million, $43 million and $214 million in the first, second and third quarter of 2025, respectively, and $38 million, $37 million and $39 million in the first, second and third quarter of 2024, respectively.

 

(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 $95 million, $5 million and $11 million in the first, second and third quarter of 2025, respectively, and $61 million, $15 million and $15 million in the first, second and third quarter of 2024, respectively.  

 

 

Exhibit 99.2

 

MERCK & CO., INC., RAHWAY, N.J., USA

CONSOLIDATED STATEMENT OF INCOME - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1a

 

   2025   2024   % Change 
    1Q    2Q    3Q    Sep
YTD
    1Q    2Q    3Q    Sep
YTD
    4Q    Full
Year
    3Q    Sep
YTD
 
Sales  $15,529   $15,806   $17,276   $48,611   $15,775   $16,112   $16,657   $48,544   $15,624   $64,168    4%   0%
                                                             
Costs, Expenses and Other                                                            
Cost of sales   3,419    3,557    3,855    10,831    3,540    3,745    4,080    11,365    3,828    15,193    -6%   -5%
Selling, general and administrative   2,552    2,649    2,633    7,835    2,483    2,739    2,731    7,952    2,864    10,816    -4%   -1%
Research and development   3,621    4,048    4,234    11,903    3,992    3,500    5,862    13,354    4,585    17,938    -28%   -11%
Restructuring costs   69    560    47    676    123    80    56    258    51    309    -16%   * 
Other (income) expense, net   (35)   (7)   (238)   (281)   (33)   42    (162)   (151)   126    (24)   47%   86%
Income Before Taxes   5,903    4,999    6,745    17,647    5,670    6,006    4,090    15,766    4,170    19,936    65%   12%
Income Tax Provision   818    571    958    2,346    903    545    929    2,377    425    2,803           
Net Income   5,085    4,428    5,787    15,301    4,767    5,461    3,161    13,389    3,745    17,133    83%   14%
Less: Net Income Attributable to Noncontrolling Interests   6    1    2    10    5    6    4    15    2    16           
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA  $5,079   $4,427   $5,785   $15,291   $4,762   $5,455   $3,157   $13,374   $3,743   $17,117    83%   14%
                                                             
Earnings per Common Share Assuming Dilution  $2.01   $1.76   $2.32   $6.08   $1.87   $2.14   $1.24   $5.26   $1.48   $6.74    87%   16%
                                                             
Average Shares Outstanding Assuming Dilution   2,531    2,513    2,498    2,514    2,544    2,544    2,541    2,543    2,537    2,541           
Tax Rate   13.9%   11.4%   14.2%   13.3%   15.9%   9.1%   22.7%   15.1%   10.2%   14.1%          

 

* 100% or greater

 

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA

THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024 GAAP TO NON-GAAP RECONCILIATION

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2b

 

   GAAP   Acquisition and
Divestiture-
Related Costs
(1)
   Restructuring
Costs
(2)
   (Income) Loss
from
Investments
in Equity
Securities
   Certain
Other Items
   Adjustment
Subtotal
   Non-GAAP 
Third Quarter                                   
Cost of sales  $4,080    639    192              831   $3,249 
Selling, general and administrative   2,731    43    31              74    2,657 
Research and development   5,862    24                   24    5,838 
Restructuring costs   56         56              56     
Other (income) expense, net   (162)   (27)        58         31    (193)
Income Before Taxes   4,090    (679)   (279)   (58)        (1,016)   5,106 
Income Tax Provision (Benefit)   929    (129)(3)   (46)(3)   (13)(3)        (188)   1,117 
Net Income   3,161    (550)   (233)   (45)        (828)   3,989 
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   3,157    (550)   (233)   (45)        (828)   3,985 
Earnings per Common Share Assuming Dilution  $1.24    (0.22)   (0.09)   (0.02)        (0.33)  $1.57 
                                    
Tax Rate   22.7%                            21.9%
                                    
Sep YTD                                   
Cost of sales  $11,365    1,708    374              2,082   $9,283 
Selling, general and administrative   7,952    88    67              155    7,797 
Research and development   13,354    60    2              62    13,292 
Restructuring costs   258         258              258     
Other (income) expense, net   (151)   (48)        (107)        (155)   4 
Income Before Taxes   15,766    (1,808)   (701)   107         (2,402)   18,168 
Income Tax Provision (Benefit)   2,377    (350)(3)   (118)(3)   23(3)   (259)(4)   (704)   3,081 
Net Income   13,389    (1,458)   (583)   84    259    (1,698)   15,087 
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   13,374    (1,458)   (583)   84    259    (1,698)   15,072 
Earnings per Common Share Assuming Dilution   $5.26    (0.57)   (0.23)   0.03    0.10    (0.67)  $5.93 
                                    
Tax Rate   15.1%                            17.0%

 

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 primarily reflect expenses for the amortization of intangible assets. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. Amounts included in research and development expenses primarily reflect the amortization of intangible assets and Animal Health intangible asset impairment charges. Amounts included in other (income) expense, net, primarily reflect royalty income related to the prior termination of the Sanofi-Pasteur MSD joint venture.

 

(2) Amounts primarily include employee separation costs, accelerated depreciation and asset impairments associated with facilities to be closed or divested related to activities under the Company's formal restructuring programs.

 

(3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.

 

(4) Represents 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 the 2019 federal tax return year.

 

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA

FRANCHISE / KEY PRODUCT SALES

THIRD QUARTER 2025

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3a

 

   Global   U.S.   International 
   3Q 2025   3Q 2024   % Change   3Q 2025   3Q 2024   % Change   3Q 2025   3Q 2024   % Change 
TOTAL SALES (1)   $17,276   $16,657    4   $10,012   $8,736    15   $7,264   $7,922    -8 
PHARMACEUTICAL   15,611    14,943    4    9,493    8,227    15    6,118    6,717    -9 
Oncology                                             
Keytruda   8,142    7,429    10    4,879    4,500    8    3,263    2,929    11 
Alliance Revenue – Lynparza (2)   379    337    12    184    161    14    195    177    11 
Alliance Revenue – Lenvima (2)   258    251    3    177    173    2    81    78    4 
Welireg   196    139    42    161    127    27    35    12    196 
Alliance Revenue – Reblozyl (3)   136    100    36    111    82    35    25    18    40 
Vaccines (4)                                             
Gardasil/Gardasil 9   1,749    2,306    -24    1,154    1,020    13    595    1,285    -54 
ProQuad/M-M-R II/Varivax   684    703    -3    554    572    -3    130    131    -1 
Capvaxive   244    47    *    238    47    *    7    0    * 
Vaxneuvance   226    239    -6    134    137    -1    91    103    -11 
RotaTeq   204    193    6    141    131    8    63    62    2 
Pneumovax 23   45    68    -34    10    19    -48    35    49    -28 
Hospital Acute Care                                             
Bridion   439    420    5    392    339    15    47    81    -42 
Prevymis   266    208    28    128    101    27    138    107    29 
Zerbaxa   81    64    25    49    39    25    32    26    25 
Dificid   43    96    -55    30    83    -64    13    13    -2 
Cardiovascular                                             
Winrevair   360    149    141    335    147    129    25    3    * 
Alliance Revenue - Adempas/Verquvo (5)   112    102    9    103    96    8    8    7    25 
Adempas (6)   82    72    14                   82    72    14 
Virology                                             
Lagevrio   138    383    -64    24    84    -71    114    299    -62 
Isentress/Isentress HD   82    102    -20    44    54    -18    37    48    -23 
Delstrigo   77    65    19    13    15    -13    64    50    29 
Pifeltro   43    42    1    29    31    -7    14    12    21 
Neuroscience                                             
Belsomra   47    78    -40    28    20    40    19    58    -67 
Immunology                                             
Simponi        189    -100                        189    -100 
Remicade        41    -100                        41    -100 
Diabetes (7)                                             
Januvia   382    278    37    258    67    *    124    211    -42 
Janumet   243    204    19    78    15    *    165    190    -13 
Other Pharmaceutical (8)   953    638    50    239    167    43    716    466    54 
ANIMAL HEALTH   1,615    1,487    9    504    487    3    1,112    999    11 
Livestock   1,023    886    16    213    194    10    811    692    17 
Companion Animal   592    601    -2    291    293    -1    301    307    -2 
Other Revenues (9)   50    227    -78    15    22    -32    34    206    -83 

 

*200% or greater

Sum of U.S. plus international may not equal global 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 $3,370 million and $3,675 million on a global basis in the third quarter of 2025 and 2024, respectively.

 

(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 $703 million and $592 million on a global basis in the third quarter of 2025 and 2024, respectively.

 

(8) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $214 million and $39 million on a global basis in the third quarter of 2025 and 2024, respectively.

 

(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 $11 million and $15 million in the third quarter of 2025 and 2024, respectively.

 

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA

FRANCHISE / KEY PRODUCT SALES

SEPTEMBER YEAR-TO-DATE 2025

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3b

 

   Global   U.S.   International 
   Sep YTD
2025
   Sep YTD
2024
   %
Change
   Sep YTD
2025
   Sep YTD
2024
   %
Change
   Sep YTD
2025
   Sep YTD
2024
   %
Change
 
TOTAL SALES (1)   $48,611   $48,544    0   $27,371   $24,089    14   $21,240   $24,455    -13 
PHARMACEUTICAL   43,299    43,358    0    25,747    22,563    14    17,552    20,795    -16 
Oncology                                             
Keytruda   23,303    21,646    8    13,936    13,031    7    9,367    8,614    9 
Alliance Revenue – Lynparza (2)   1,061    947    12    503    449    12    558    498    12 
Alliance Revenue – Lenvima (2)   781    755    3    545    523    4    236    233    2 
Welireg   496    349    42    422    320    32    74    29    157 
Alliance Revenue – Reblozyl (3)   361    261    39    299    215    39    62    45    37 
Vaccines (4)                                             
Gardasil/Gardasil 9   4,202    7,032    -40    2,235    2,045    9    1,967    4,988    -61 
ProQuad/M-M-R II/Varivax   1,832    1,891    -3    1,457    1,500    -3    374    391    -4 
Vaxneuvance   685    647    6    409    397    3    276    251    10 
RotaTeq   554    572    -3    366    388    -6    187    185    2 
Capvaxive   480    47    *    473    47    *    8    0    * 
Pneumovax 23   124    188    -34    13    36    -63    111    152    -27 
Hospital Acute Care                                             
Bridion   1,341    1,315    2    1,181    1,020    16    161    296    -46 
Prevymis   702    570    23    345    265    30    357    305    17 
Zerbaxa   225    182    24    136    106    29    89    77    16 
Dificid   222    261    -15    185    231    -20    37    30    21 
Cardiovascular                                             
Winrevair   976    219    *    926    216    *    49    3    * 
Alliance Revenue - Adempas/Verquvo (5)   340    306    11    308    283    9    32    22    43 
Adempas (6)   229    214    7                   229    214    7 
Virology                                             
Lagevrio   323    843    -62    90    144    -38    233    699    -67 
Isentress/Isentress HD   258    302    -15    144    147    -2    114    155    -26 
Delstrigo   228    180    26    42    42    1    185    139    33 
Pifeltro   128    123    4    86    86    -1    43    37    16 
Neuroscience                                             
Belsomra   137    177    -23    59    53    12    77    124    -38 
Immunology                                             
Simponi        545    -100                        545    -100 
Remicade        115    -100                        115    -100 
Diabetes (7)                                             
Januvia   1,302    1,102    18    819    428    91    483    674    -28 
Janumet   741    679    9    210    70    *    530    610    -13 
Other Pharmaceutical (8)   2,268    1,890    20    558    521    7    1,713    1,364    26 
ANIMAL HEALTH   4,849    4,480    8    1,505    1,417    6    3,345    3,063    9 
Livestock   2,909    2,573    13    598    529    13    2,312    2,044    13 
Companion Animal   1,940    1,907    2    907    888    2    1,033    1,019    1 
Other Revenues (9)   463    706    -34    119    109    9    343    597    -43 

 

*200% or greater

Sum of U.S. plus international may not equal global 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 $8,347 million and $10,755 million on a global basis for September YTD 2025 and 2024, respectively.

 

(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 $2,283 million and $2,053 million on a global basis for September YTD 2025 and 2024, respectively.

 

(8) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $301 million and $114 million on a global basis for September YTD 2025 and 2024, respectively.

 

(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 $111 million and $91 million on a global basis for September YTD 2025 and 2024, respectively.

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA

PHARMACEUTICAL GEOGRAPHIC SALES

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3c

 

   2025   2024     % Change 
   1Q   2Q   3Q   Sep YTD   1Q   2Q   3Q   Sep YTD   4Q   Full Year   3Q  Sep YTD 
TOTAL PHARMACEUTICAL  $13,638   $14,050   $15,611   $43,299   $14,006   $14,408   $14,943   $43,358   $14,042   $57,400    4    0 
United States   7,927    8,328    9,493    25,747    6,936    7,399    8,227    22,563    7,728    30,290    15    14 
% Pharmaceutical Sales   58.1%   59.3%   60.8%   59.5%   49.5%   51.4%   55.1%   52.0%   55.0%   52.8%          
Europe (1)   2,384    2,551    2,675    7,610    2,555    2,572    2,620    7,748    2,498    10,246    2    -2 
% Pharmaceutical Sales   17.5%   18.2%   17.1%   17.6%   18.2%   17.9%   17.5%   17.9%   17.8%   17.9%          
Japan   651    604    693    1,948    802    664    919    2,386    813    3,199    -25    -18 
% Pharmaceutical Sales   4.8%   4.3%   4.4%   4.5%   5.7%   4.6%   6.2%   5.5%   5.8%   5.6%          
Latin America   589    654    691    1,933    601    661    730    1,992    680    2,672    -5    -3 
% Pharmaceutical Sales   4.3%   4.7%   4.4%   4.5%   4.3%   4.6%   4.9%   4.6%   4.8%   4.7%          
Asia Pacific (other than China and Japan)   535    609    593    1,736    580    595    669    1,844    612    2,457    -11    -6 
% Pharmaceutical Sales   3.9%   4.3%   3.8%   4.0%   4.1%   4.1%   4.5%   4.3%   4.4%   4.3%          
China (2)   668    407    377    1,452    1,744    1,790    996    4,530    864    5,394    -62    -68 
% Pharmaceutical Sales   4.9%   2.9%   2.4%   3.4%   12.5%   12.4%   6.7%   10.4%   6.2%   9.4%          
Eastern Europe/Middle East/Africa   435    451    365    1,250    395    353    400    1,147    348    1,495    -9    9 
% Pharmaceutical Sales   3.2%   3.2%   2.3%   2.9%   2.8%   2.4%   2.7%   2.6%   2.5%   2.6%          
Canada   125    135    134    394    138    143    133    414    144    558    1    -5 
% Pharmaceutical Sales   0.9%   1.0%   0.9%   0.9%   1.0%   1.0%   0.9%   1.0%   1.0%   1.0%          
Other   324    311    590    1,229    255    231    249    734    355    1,089    137    67 
% Pharmaceutical Sales   2.4%   2.1%   3.9%   2.7%   1.9%   1.6%   1.5%   1.7%   2.5%   1.7%          

 

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.

 

(1) Europe represents all European Union countries, the European Union accession markets and the United Kingdom.    

 

(2) Gardasil/Gardasil 9 sales in China were $193 million, $0 and $0 in the first, second and third quarter of 2025, respectively, and $1,253 million, $1,312 million, $517 million and $446 million in the first, second, third and fourth quarter of 2024, respectively.    

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA

OTHER (INCOME) EXPENSE, NET - GAAP

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 4

 

OTHER (INCOME) EXPENSE, NET

 

   3Q25   3Q24   Sep YTD
2025
   Sep YTD
2024
 
Interest income  $(96)  $(127)  $(274)  $(269)
Interest expense   327    330    946    943 
Exchange losses   56    33    224    177 
(Income) loss from investments in equity securities, net (1)   (373)   31    (563)   (169)
Net periodic defined benefit plan (credit) cost other than service cost   (152)   (157)   (452)   (476)
Other, net   -    (272)   (162)   (357)
Total  $(238)  $(162)  $(281)  $(151)

 

(1) Includes net realized and unrealized gains and losses from investments in equity securities either owned directly or through ownership interests in investment funds. Unrealized gains and losses from investments that are directly owned are determined at the end of the reporting period, while gains and losses from ownership interests in investment funds are accounted for on a one quarter lag.