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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) July 29, 2025 (July 25, 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 (732) 594-4000

 

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 July 29, 2025, regarding earnings for the second 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 2.05. Costs Associated with Exit or Disposal Activities.

 

On July 25, 2025, the Company approved a new restructuring program (2025 Restructuring Program) designed to position the Company for its next chapter of growth and to successfully advance its pipeline and launch new products across multiple therapeutic areas. As part of this program, the Company expects to eliminate certain positions in sales and administrative organizations, as well as research and development. The Company will, however, continue to hire employees into new roles across all strategic growth areas of the business. In addition, the Company will reduce its global real estate footprint and continue to optimize its manufacturing network, aligning the geography of its global manufacturing footprint to its customers and reflecting changes in the Company’s business.

 

Most actions contemplated under the 2025 Restructuring Program are expected to be largely completed by the end of 2027, with the exception of certain manufacturing actions, which are expected to be substantially completed by the end of 2029. The cumulative pretax costs to be incurred by the Company to implement the program are estimated to be approximately $3.0 billion, of which approximately 60% will be cash, relating primarily to employee separation expense and contractual termination costs. The remainder of the costs will be non-cash, relating primarily to the accelerated depreciation of facilities. The Company expects the actions under the 2025 Restructuring Program to result in annual cost savings of approximately $1.7 billion, which will be substantially realized by the end of 2027. The 2025 Restructuring Program is part of the Company’s multiyear optimization initiative anticipated to achieve $3.0 billion in annual cost savings by the end of 2027, which will be fully reinvested into strategic growth areas of the business.

 

Item 9.01. Financial Statements and Exhibits.

 

  (d) Exhibits  
     
  Exhibit 99.1 Press release issued July 29, 2025, regarding earnings for the second 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: July 29, 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 Second-Quarter 2025 Financial Results

 

-Total Worldwide Sales Were $15.8 Billion, a Decrease of 2% From Second Quarter 2024 Both Nominally and Excluding the Impact of Foreign Exchange
oKEYTRUDA Sales Were $8.0 Billion, Growth of 9% Both Nominally and Excluding the Impact of Foreign Exchange
oWINREVAIR Sales Were $336 Million
oAnimal Health Sales Were $1.6 Billion, Growth of 11% Both Nominally and Excluding the Impact of Foreign Exchange

oGARDASIL/GARDASIL 9 Sales Were $1.1 Billion, a Decline of 55% Both Nominally and Excluding the Impact of Foreign Exchange

-GAAP EPS Was $1.76; Non-GAAP EPS Was $2.13; GAAP and Non-GAAP EPS Include a Charge of $0.07 per Share for Closing of Hengrui Pharma License Agreement

-Announced Agreement To Acquire Verona Pharma and Its First-In-Class COPD Maintenance Treatment for Adults, Ohtuvayre®;1 Transaction Expected To Close in Fourth Quarter 2025

-Announced Positive Topline Results From First Two Phase 3 CORALreef Trials of Enlicitide Decanoate for Treatment of Adults With Hyperlipidemia

-Received FDA Approval of ENFLONSIA for Prevention of RSV Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season; CDC’s ACIP Recommended ENFLONSIA for Prevention of RSV in Infants Younger Than 8 Months of Age for Their First RSV Season

-Announced Multiyear Optimization Initiative Anticipated To Result in Approximately $3.0 Billion of Annual Cost Savings by the End of 2027, To Be Fully Reinvested Into Strategic Growth Areas

-Full-Year 2025 Financial Outlook

oNarrows Expected Worldwide Sales Range To Be Between $64.3 Billion and $65.3 Billion

oNarrows Expected Non-GAAP EPS Range To Be Between $8.87 and $8.97

oOutlook Does Not Include Anticipated Impact of the Announced Acquisition of Verona Pharma

 

RAHWAY, N.J., July 29, 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 second quarter of 2025.

 

 

1 All trademarks are property of their respective owners.

 

 

- 2 -

 

"Earlier this month, we were pleased to announce our pending acquisition of Verona Pharma, which augments our portfolio and pipeline and is another example of acting decisively when science and value align,” said Robert M. Davis, chairman and chief executive officer. “Today, we announced a multiyear optimization initiative that will redirect investment and resources from more mature areas of our business to our burgeoning array of new growth drivers, further enable the transformation of our portfolio, and drive our next chapter of productive, innovation-driven growth. With these actions, I am confident that we are well positioned to generate near- and long-term value for our shareholders and, most importantly, deliver for our patients.”

 

Financial Summary

  

   Second Quarter 
$ in millions, except EPS amounts  2025   2024   Change   Change
Ex-Exchange
 
Sales  $15,806   $16,112    -2%   -2%
GAAP net income2   4,427    5,455    -19%   -17%
Non-GAAP net income that excludes certain items2,3*   5,366    5,809    -8%   -6%
GAAP EPS   1.76    2.14    -18%   -16%
Non-GAAP EPS that excludes certain items3*   2.13    2.28    -7%   -5%

 

 *Refer to table on page 7.

 

For the second quarter of 2025, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.76 and non-GAAP EPS was $2.13. GAAP and non-GAAP EPS in the second quarter of 2025 include a charge of $0.07 per share for an upfront payment to Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) upon closing of a license agreement. 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 the second quarter of 2025 also excludes tax benefits primarily resulting from favorable audit adjustments. Non-GAAP EPS in the second quarter of 2024 also excludes a tax 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.

 

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

 

 

2 Net income attributable to the Company.

3 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 -

 

Second-Quarter Sales Performance

 

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

 

   Second Quarter 
$ in millions  2025   2024   Change   Change
Ex-Exchange
   Commentary
Total Sales  $15,806   $16,112    -2%   -2%   
Pharmaceutical   14,050    14,408    -2%   -3%  Decline primarily due to vaccines and immunology, partially offset by growth in oncology and cardiology.
KEYTRUDA   7,956    7,270    9%   9%  Growth driven by continued strong global demand from metastatic indications, including bladder, endometrial and gastric cancers, and increased global uptake in earlier-stage indications, including triple-negative breast cancer, renal cell carcinoma (RCC) and cervical cancer, as well as non-small cell lung cancer in the U.S.
GARDASIL/GARDASIL 9   1,126    2,478    -55%   -55%  Decline primarily due to lower demand in China. Excluding China, sales declined 3%, or 4% excluding impact of foreign exchange, reflecting lower demand in Japan following a national catch-up immunization program, as well as timing of public-sector purchases in certain international markets. U.S. sales increased 2% in the quarter.
JANUVIA/JANUMET   623    629    -1%   -   Decrease primarily attributable to lower demand in China, impacts of generic competition in most international markets, and lower demand in the U.S. due to competitive pressure, which were largely offset by higher net pricing in the U.S.
PROQUAD, M-M-R II and VARIVAX   609    617    -1%   -2%  Decrease primarily reflects lower U.S. sales due to unfavorable VARIVAX public-sector activity and M-M-R II private-sector buy-out, partially offset by partial replenishment of PROQUAD doses borrowed from the U.S. Centers for Disease Control and Prevention (CDC) Pediatric Vaccine Stockpile, and higher pricing.
BRIDION   461    455    1%   1%  Increase primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition.
Lynparza*   370    317    17%   15%  Growth primarily due to higher demand in the U.S. and certain international markets.
WINREVAIR   336    70    N/M    N/M   Growth reflects continued uptake since second-quarter 2024 launch in the U.S.

 

 

- 4 -

  

    Second Quarter  
$ in millions   2025     2024     Change     Change
Ex-Exchange
    Commentary
Lenvima*     265       249       6 %     5 %   Increase primarily due to higher sales in the U.S. reflecting higher demand, partially offset by lower pricing.
VAXNEUVANCE     229       189       21 %     20 %   Growth primarily due to favorable public-sector activity in the U.S. and increased demand in certain international markets, partially offset by lower demand in the U.S. and Japan due to competitive pressure.
PREVYMIS     228       188       21 %     20 %   Growth primarily due to higher demand in the U.S. and Europe, partially offset by lower demand in China due to generic competition.
WELIREG     162       126       29 %     29 %   Growth primarily driven by higher demand in the U.S. and early launch uptake in certain EU markets, partially offset by lower pricing in the U.S.
CAPVAXIVE     129       -       -       -     Represents continued uptake since third-quarter 2024 launch in the U.S.
SIMPONI     -       172       -100 %     -100 %   Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024.
Animal Health     1,646       1,482       11 %     11 %   Growth primarily due to higher demand for Livestock products, as well as inclusion of sales from Elanco aqua business acquired in July 2024, higher pricing and improved supply.
Livestock     961       837       15 %     16 %   Growth primarily driven by higher demand across all species, as well as inclusion of sales from Elanco aqua business acquired in July 2024.
Companion Animal     685       645       6 %     6 %   Increase primarily driven by higher pricing. Sales of BRAVECTO were $335 million and $331 million in current and prior year quarters, respectively, which represents an increase of 1%, both nominally and excluding impact of foreign exchange.
Other Revenues**     110       222       -50 %     -3 %   Primarily due to unfavorable impact of revenue-hedging activities.

 

*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 -

 

Second-Quarter Expense, EPS and Related Information

 

The table below presents selected expense information.

 

$ in millions  GAAP   Acquisition-
and
Divestiture-
Related Costs4
   Restructuring
Costs
   (Income)
Loss From
Investments
in Equity
Securities
   Non-
GAAP3
 
Second Quarter 2025                    
Cost of sales  $3,557   $576   $165   $-   $2,816 
Selling, general and administrative   2,649    15    1    -    2,633 
Research and development   4,048    3    53    -    3,992 
Restructuring costs   560    -    560    -    - 
Other (income) expense, net   (7)   -    -    (61)   54 
                          
Second Quarter 2024                         
Cost of sales  $3,745   $606   $66   $-   $3,073 
Selling, general and administrative   2,739    24    31    -    2,684 
Research and development   3,500    20    -    -    3,480 
Restructuring costs   80    -    80    -    - 
Other (income) expense, net   42    (17)   -    (49)   108 

 

GAAP Expense, EPS and Related Information

 

Gross margin was 77.5% for the second quarter of 2025 compared with 76.8% for the second quarter of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by higher restructuring costs and inventory write-offs.

 

Selling, general and administrative (SG&A) expenses were $2.6 billion in the second quarter of 2025, a decrease of 3% compared with the second quarter of 2024. The decrease was primarily due to lower administrative, restructuring and promotional costs.

 

Research and development (R&D) expenses were $4.0 billion in the second quarter of 2025, an increase of 16% compared with the second quarter of 2024. The increase was primarily due to a $200 million charge for an upfront payment made in the second quarter of 2025 for a license agreement with Hengrui Pharma, increased clinical development spending, higher compensation and benefit costs, and higher restructuring costs.

 

Other (income) expense, net, was $7 million of income in the second quarter of 2025 compared with $42 million of expense in the second quarter of 2024.

 

The effective tax rate of 11.4% for the second quarter of 2025 includes a 2.9 percentage point favorable impact due to tax benefits primarily resulting from favorable audit adjustments.

 

 

4 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 -

 

GAAP EPS was $1.76 for the second quarter of 2025 compared with $2.14 for the second quarter of 2024. The decrease reflects increased operating expenses driven by higher restructuring costs and research and development spending, a charge related to the closing of a license agreement with Hengrui Pharma, unfavorable tax impacts, and the unfavorable impact of foreign exchange.

 

Non-GAAP Expense, EPS and Related Information

 

Non-GAAP gross margin was 82.2% for the second quarter of 2025 compared with 80.9% for the second quarter of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by higher inventory write-offs.

 

Non-GAAP SG&A expenses were $2.6 billion in the second quarter of 2025, a decrease of 2% compared with the second quarter of 2024. The decrease was primarily due to lower administrative and promotional costs.

 

Non-GAAP R&D expenses were $4.0 billion in the second quarter of 2025, an increase of 15% compared with the second quarter of 2024. The increase was primarily due to a $200 million charge for an upfront payment made in the second quarter of 2025 for a license agreement with Hengrui Pharma, increased clinical development spending, and higher compensation and benefit costs.

 

Non-GAAP other (income) expense, net, was $54 million of expense in the second quarter of 2025 compared with $108 million of expense in the second quarter of 2024.

 

The non-GAAP effective tax rate was 15.0% for the second quarter of 2025.

 

Non-GAAP EPS was $2.13 for the second quarter of 2025 compared with $2.28 for the second quarter of 2024. The decrease reflects increased operating expenses driven by higher research and development spending, a charge related to the closing of a license agreement with Hengrui Pharma, and the unfavorable impact of foreign exchange.

 

 

- 7 -

 

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

 

   Second Quarter 
$ in millions, except EPS amounts  2025   2024 
EPS          
GAAP EPS  $1.76   $2.14 
Difference   0.37    0.14 
Non-GAAP EPS that excludes items listed below3  $2.13   $2.28 
           
Net Income          
GAAP net income2  $4,427   $5,455 
Difference   939    354 
Non-GAAP net income that excludes items listed below2,3  $5,366   $5,809 
           
Excluded Items:          
Acquisition- and divestiture-related costs4  $594   $633 
Restructuring costs   779    177 
Income from investments in equity securities   (61)   (49)
Decrease to net income before taxes   1,312    761 
Estimated income tax (benefit) expense5   (373)   (407)
Decrease to net income  $939   $354 

 

Planned Acquisition of Verona Pharma

 

On July 9, 2025, the Company furthered its science-led business development strategy by announcing an agreement under which the Company, through a subsidiary, will acquire Verona Pharma plc (Verona Pharma) for $107 per American Depository Share, each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately $10 billion. Through the acquisition, the Company will add Ohtuvayre, a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), to its growing cardio-pulmonary pipeline and portfolio.

 

The U.S. Food and Drug Administration (FDA) approved Ohtuvayre in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is the first novel inhaled mechanism for the treatment of COPD in more than 20 years. The transaction is anticipated to close in the fourth quarter of 2025.

 

Pipeline and Portfolio Highlights

 

In the second quarter, the Company continued to advance its broad and diverse pipeline with multiple regulatory and clinical milestones.

 

In oncology, the FDA approved KEYTRUDA as part of a therapy regimen for the treatment of certain adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC), based on results from the Phase 3 KEYNOTE-689 trial. This approval is the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced HNSCC whose tumors express PD-L1 (CPS ≥1). In addition, the Ministry of Health, Labor and Welfare (MHLW) in Japan approved WELIREG as monotherapy for the treatment of adults with von Hippel-Lindau (VHL) disease-associated tumors, and for adults with unresectable or metastatic RCC that has progressed after chemotherapy.

 

 

5 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 second quarter of 2025 also includes a $146 million benefit primarily resulting from favorable audit adjustments. Amount in the second quarter of 2024 also includes a $259 million 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.

 

 

- 8 -

 

At the 2025 American Society of Clinical Oncology Annual Meeting, the Company announced new research across more than 25 types of cancer in multiple treatment settings. Data were presented for several candidates, including MK-1084, an investigational oral selective KRAS G12C inhibitor, and from the Company’s pipeline of antibody-drug conjugates (ADCs). The Company also presented data from Phase 3 trials evaluating new combination regimens with KEYTRUDA, and longer-term data for studies of KEYTRUDA and WELIREG, with the KEYTRUDA studies including people with earlier stages of cancer.

 

The Company announced results from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65) evaluating KEYTRUDA plus chemotherapy, which met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 and in all comers, as well as a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. In addition, a pre-specified interim analysis of the Phase 3 KEYNOTE-937 study found that compared to placebo, KEYTRUDA did not show a statistically significant improvement in the primary endpoint of recurrence-free survival for certain patients with hepatocellular carcinoma. Also, a pre-specified interim analysis of the Phase 3 LEAP-014 trial found that KEYTRUDA plus Lenvima, in combination with platinum-based chemotherapy, did not show a statistically significant improvement in its primary endpoint of OS compared to KEYTRUDA plus chemotherapy for the first-line treatment of patients with metastatic esophageal squamous cell carcinoma (ESCC).

 

In vaccines and infectious diseases, the Company received FDA approval of ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. ENFLONSIA is the first and only RSV preventive option administered to infants using the same dose regardless of weight. The CDC’s Advisory Committee on Immunization Practices (ACIP) also recommended ENFLONSIA for the prevention of RSV in infants younger than 8 months of age born during or entering their first RSV season. In addition, the Company announced initiation of the MOBILIZE-1 Phase 3 trial evaluating V181, an investigational single-dose quadrivalent vaccine for the prevention of dengue disease.

 

In addition, the FDA accepted a New Drug Application (NDA) for doravirine/islatravir, an investigational, once-daily, oral, two-drug regimen for the treatment of adults with virologically suppressed HIV-1 based on the Phase 3 MK-8591A-051 and MK-8591A-052 trials. The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026. The Company also announced the initiation of the EXPrESSIVE Phase 3 trials for MK-8527, its investigational once-monthly oral candidate for HIV pre-exposure prophylaxis (PrEP).

 

 

- 9 -

 

In cardiovascular disease, the Company announced positive topline results from Phase 3 CORALreef HeFH and CORALreef AddOn, the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia already on lipid-lowering therapies, including at least a statin. In both trials, enlicitide demonstrated statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol. If approved, it would be the first marketed oral PCSK9 inhibitor.

 

In addition, the FDA granted priority review for a new supplemental Biologics License Application for WINREVAIR seeking approval to update the U.S. product label based on compelling results from the Phase 3 ZENITH trial. The FDA has set a PDUFA date of Oct. 25, 2025. The Company also provided an update on the Phase 3 HYPERION study evaluating WINREVAIR in recently diagnosed adults with pulmonary arterial hypertension (PAH). In the study, WINREVAIR added on top of background therapy within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo. Further, the MHLW in Japan approved sotatercept for the treatment of adults with PAH under the trademark AIRWIN. It is the first activin signaling inhibitor therapy for PAH approved in Japan.

 

In the Animal Health business, the FDA approved BRAVECTO QUANTUM, an injectable formulation of BRAVECTO for dogs for the treatment and persistent killing of fleas and ticks. In addition, the European Commission (EC) approved NUMELVI tablets for dogs, a once-daily, second-generation Janus kinase (JAK) inhibitor, indicated for the treatment of pruritus associated with allergic dermatitis including atopic dermatitis and treatment of clinical manifestations of atopic dermatitis.

 

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 for PD-L1+ Resectable Locally Advanced HNSCC as Neoadjuvant Treatment, Continued as Adjuvant Treatment Combined With Radiotherapy With or Without Cisplatin Then as a Single Agent; Based on Results From Phase 3 KEYNOTE-689 Trial
FDA Approved WELIREG for Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma; Based on Results From Phase 2 LITESPARK-015 Clinical Trial
Phase 3 KEYNOTE-B96 Trial Met Primary Endpoint of PFS in Patients With Platinum-Resistant Recurrent Ovarian Cancer Whose Tumors Expressed PD-L1 and in All Comers
KEYTRUDA Plus Trodelvy Reduced Risk of Disease Progression or Death by 35% Versus KEYTRUDA Plus Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer; Based on Results From Phase 3 ASCENT-04/KEYNOTE-D19 Trial
MK-1084, an Investigational KRAS G12C Inhibitor, Showed Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations
Investigational Zilovertamab Vedotin at 1.75 mg/kg Dose Plus Standard of Care Showed Promising Antitumor Activity, Including Complete Response Rate, in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma; Based on Results From Phase 2 WaveLINE-003 Trial
IDeate-Prostate01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Patients With Pretreated Metastatic Castration-Resistant Prostate Cancer
IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients With Pretreated Advanced or Metastatic ESCC

 

 

- 10 -

 

Vaccines and Infectious Diseases FDA Approved ENFLONSIA for Prevention of RSV Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season; Based on Results From Phase 2b/3 CLEVER Trial
ACIP Recommended Use of ENFLONSIA for Prevention of RSV Lower Respiratory Tract Disease in Infants Younger Than 8 Months of Age Born During or Entering Their First RSV Season
FDA Accepted NDA for Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults With Virologically Suppressed HIV-1; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials; FDA Set PDUFA Date of April 28, 2026
EXPrESSIVE Phase 3 Trials Initiated for Investigational Once-Monthly HIV Prevention Pill, MK-8527
The Company Initiated MOBILIZE-1 Phase 3 Study Evaluating Dengue Vaccine Candidate
Cardiovascular FDA Granted Priority Review for WINREVAIR to Update Label Based on Results From ZENITH Trial; FDA Set PDUFA Date of Oct. 25, 2025
The Company Announced Positive Topline Results From First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia
Phase 3 HYPERION Study of WINREVAIR Met Primary Endpoint in Recently Diagnosed Adults With PAH
Animal Health FDA Approved BRAVECTO QUANTUM
EC Approved NUMELVI Tablets for Dogs

 

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

 

New Multiyear Optimization Initiative, Which Includes a Restructuring Program

 

The Company launched a new multiyear optimization initiative to enable the transformation of its portfolio by generating an expected $3.0 billion in annual cost savings from productivity actions, which will be fully reinvested to support new product launches and its pipeline across multiple therapeutic areas.

 

In July 2025, as part of this initiative, the Company approved a new restructuring program, in which it expects to eliminate certain administrative, sales and R&D positions. The Company will, however, continue to hire employees into new roles across strategic growth areas of the business. In addition, the Company will reduce its global real estate footprint and continue to optimize its manufacturing network, aligning the geography of its global manufacturing to its customers and reflecting changes in the Company’s business.

 

The Company anticipates cumulative pretax costs related to the program to be approximately $3.0 billion. For the second quarter of 2025, the Company recorded charges in its GAAP results of $649 million related to this restructuring program.

 

The Company expects the actions under the restructuring program to result in annual cost savings of approximately $1.7 billion, which will be substantially realized by the end of 2027. This restructuring program is part of the multiyear optimization initiative expected to achieve $3.0 billion in annual cost savings by the end of 2027.

 

 

- 11 -

 

Manufacturing and R&D Investment

 

The Company continued to make long-term investments in its U.S. manufacturing and R&D capabilities. This includes the start of construction for a $1.0 billion, 470,000-square-foot state-of-the-art biologics center of excellence in Wilmington, Delaware, which will serve as a launch and commercial production facility and the primary U.S. manufacturing site for KEYTRUDA. In addition, the Company announced an $895 million expansion of its Animal Health manufacturing facility in De Soto, Kansas; the 200,000-square-foot facility will increase capacity for Animal Health vaccines and biologic products.

 

Full-Year 2025 Financial Outlook

 

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

 

   Full Year 2025
   Updated  Prior
Sales*  $64.3 billion to $65.3 billion  $64.1 billion to $65.6 billion
Non-GAAP Gross margin3  Approximately 82%  Approximately 82%
Non-GAAP Operating expenses3**  $25.6 billion to $26.4 billion  $25.6 billion to $26.6 billion
Non-GAAP Other (income) expense, net3  $300 million to $400 million expense  $300 million to $400 million expense
Non-GAAP Effective tax rate3  15.0% to 16.0%  15.5% to 16.5%
Non-GAAP EPS3***  $8.87 to $8.97  $8.82 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.

**Includes one-time R&D charges of $300 million for a milestone payment to LaNova Medicines Ltd. (LaNova) associated with the technology transfer for MK-2010 expected to be recorded in the third quarter of 2025 and $200 million for the upfront payment for the license agreement completed with Hengrui Pharma in the second quarter of 2025.

Outlook does not assume any additional significant potential business development transactions.

***Includes one-time charges totaling $0.16 per share associated with the payment for the LaNova technology transfer for MK-2010 and upfront payment to Hengrui 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 $64.3 billion and $65.3 billion, including a revised negative impact of foreign exchange of approximately 0.5% at mid-July 2025 exchange rates.

 

The Company now expects its full-year non-GAAP effective income tax rate to be between 15.0% and 16.0%.

 

 

- 12 -

 

The Company now expects its full-year non-GAAP EPS to be between $8.87 and $8.97, including a revised negative impact of foreign exchange of approximately $0.15 per share. This revised non-GAAP EPS range continues to reflect the impacts of a one-time charge of $200 million (recorded in the second quarter of 2025) for an upfront payment made in connection with the closing of a license agreement with Hengrui Pharma and the one-time charge of $300 million (to be recorded in the third quarter of 2025) related to a payment to LaNova for the completion of the technology transfer for MK-2010, which will 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.

 

The financial outlook does not include the anticipated impact of the announced acquisition of Verona Pharma.

 

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

 

The $200 million of costs previously included in the Company’s financial outlook related to the impact of tariffs is unchanged pending the outcome of additional potential government actions.

 

Earnings Conference Call

 

Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, July 29, 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) 

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) 

Lenvima (lenvatinib) 

Lynparza (olaparib) 

M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live) 

PREVYMIS (letermovir

PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) 

SIMPONI (golimumab) 

VARIVAX (Varicella Virus Vaccine Live) 

VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine

WELIREG (belzutifan

WINREVAIR (sotatercept-csrk) 

 

 

- 14 -

 

Animal Health 

BRAVECTO (fluralaner) 

BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension) 

NUMELVI (atinvicitinib)

 

### 

 

 

Media Contacts: Investor Contacts:

 

Michael Levey

michael.levey@msd.com

 

Johanna Herrmann

johanna.herrmann@msd.com

 

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      
    2Q25   2Q24    % Change    June YTD 2025    June YTD 2024    % Change 
Sales  $15,806  $16,112    -2%  $31,335   $31,887    -2%
                              
Costs, Expenses and Other                             
Cost of sales   3,557   3,745    -5%   6,976    7,285    -4%
Selling, general and administrative   2,649   2,739    -3%   5,202    5,221    0%
Research and development   4,048   3,500    16%   7,669    7,492    2%
Restructuring costs   560   80    *     629    202    *  
Other (income) expense, net   (7)  42    *     (43)   12    *  
Income Before Taxes   4,999   6,006    -17%   10,902    11,675    -7%
Income Tax Provision   571   545         1,388    1,447      
Net Income   4,428   5,461    -19%   9,514    10,228    -7%
Less: Net Income Attributable to Noncontrolling Interests   1   6         8    11      
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA  $4,427  $5,455    -19%  $9,506   $10,217    -7%
                              
Earnings per Common Share Assuming Dilution  $1.76  $2.14    -18%  $3.77   $4.02    -6%
                              
Average Shares Outstanding Assuming Dilution   2,513   2,544         2,522    2,544      
Tax Rate   11.4%  9.1%        12.7%   12.4%     
                              
* 100% or greater                             

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA
THREE AND SIX MONTHS ENDED JUNE 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 
Second Quarter                             
Cost of sales  $3,557   576   165           741  $2,816 
Selling, general and administrative   2,649   15   1           16   2,633 
Research and development   4,048   3   53           56   3,992 
Restructuring costs   560       560           560    
Other (income) expense, net   (7)          (61)      (61)  54 
Income Before Taxes   4,999   (594)  (779)  61       (1,312)  6,311 
Income Tax Provision (Benefit)   571   (102)(3)  (139)(3)  14(3)  (146)(4)  (373)  944 
Net Income   4,428   (492)  (640)  47   146   (939)  5,367 
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   4,427   (492)  (640)  47   146   (939)  5,366 
Earnings per Common Share Assuming Dilution  $1.76   (0.20)  (0.25)  0.02   0.06   (0.37) $2.13 
                              
Tax Rate   11.4%                      15.0%
                              
June YTD                             
Cost of sales  $6,976   1,196   201           1,397  $5,579 
Selling, general and administrative   5,202   38   1           39   5,163 
Research and development   7,669   10   53           63   7,606 
Restructuring costs   629       629           629    
Other (income) expense, net   (43)  (3)      (168)      (171)  128 
Income Before Taxes   10,902   (1,241)  (884)  168       (1,957)  12,859 
Income Tax Provision (Benefit)   1,388   (219)(3)  (157)(3)  36(3)  (146)(4)  (486)  1,874 
Net Income   9,514   (1,022)  (727)  132   146   (1,471)  10,985 
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   9,506   (1,022)  (727)  132   146   (1,471)  10,977 
Earnings per Common Share Assuming Dilution  $3.77   (0.40)  (0.29)  0.05   0.06   (0.58) $4.35 
                              
Tax Rate   12.7%                      14.6%

  

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 reflect expenses for 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 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 tax benefits primarily resulting from favorable audit adjustments.

 

 

 

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

FRANCHISE / KEY PRODUCT SALES

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3

 

  2025  2024  2Q  June YTD 
  1Q  2Q  June YTD  1Q  2Q  June YTD  3Q  4Q  Full Year  Nom %  Ex-Exch %  Nom %  Ex-Exch % 
TOTAL SALES (1)  $15,529  $15,806  $31,335  $15,775  $16,112  $31,887  $16,657  $15,624  $64,168  -2  -2  -2  0 
PHARMACEUTICAL  13,638   14,050   27,688   14,006   14,408   28,415   14,943   14,042   57,400  -2  -3  -3  -2 
Oncology                                                
Keytruda  7,205   7,956   15,161   6,947   7,270   14,217   7,429   7,836   29,482  9  9  7  8 
Alliance Revenue – Lynparza (2)  312   370   682   292   317   609   337   365   1,311  17  15  12  12 
Alliance Revenue – Lenvima (2)  258   265   523   255   249   504   251   255   1,010  6  5  4  4 
Welireg  137   162   300   85   126   211   139   160   509  29  29  42  43 
Alliance Revenue – Reblozyl (3)  119   107   226   71   90   161   100   110   371  19  19  40  40 
Vaccines (4)                                                
Gardasil/Gardasil 9  1,327   1,126   2,453   2,249   2,478   4,727   2,306   1,550   8,583  -55  -55  -48  -48 
ProQuad/M-M-R II/Varivax  539   609   1,148   570   617   1,187   703   594   2,485  -1  -2  -3  -3 
Vaxneuvance  230   229   459   219   189   408   239   161   808  21  20  13  13 
RotaTeq  228   121   349   216   163   379   193   139   711  -26  -26  -8  -7 
Capvaxive  107   129   236               47   50   97  -  -  -  - 
Pneumovax 23  41   38   79   61   59   120   68   74   263  -36  -37  -35  -33 
Hospital Acute Care                                                
Bridion  441   461   902   440   455   895   420   449   1,764  1  1  1  1 
Prevymis  208   228   436   174   188   362   208   215   785  21  20  20  21 
Dificid  83   96   179   73   92   165   96   79   340  5  5  8  9 
Zerbaxa  70   74   145   56   62   118   64   70   252  21  21  23  24 
Cardiovascular                                                
Winrevair  280   336   615       70   70   149   200   419  *  *  *  * 
Alliance Revenue - Adempas/Verquvo (5)  106   123   229   98   106   203   102   109   415  16  16  12  12 
Adempas (6)  68   80   147   70   72   142   72   73   287  10  6  4  4 
Virology                                                
Lagevrio  102   83   185   350   110   460   383   121   964  -25  -27  -60  -59 
Isentress/Isentress HD  90   86   176   111   89   200   102   92   394  -3  -4  -12  -11 
Delstrigo  67   83   150   56   60   116   65   69   249  40  35  30  30 
Pifeltro  45   41   86   42   39   81   42   40   163  5  4  6  6 
Neuroscience                                                
Belsomra  50   40   90   46   53   99   78   45   222  -24  -26  -9  -8 
Immunology                                                
Simponi              184   172   356   189       543  -100  -100  -100  -100 
Remicade              39   35   74   41       114  -100  -100  -100  -100 
Diabetes (7)                                                
Januvia  549   372   921   419   405   824   278   232   1,334  -8  -8  12  13 
Janumet  247   251   498   251   224   475   204   255   935  12  14  5  8 
Other Pharmaceutical (8)  729   584   1,313   632   618   1,252   638   699   2,590  -6  -7  5  6 
ANIMAL HEALTH  1,588   1,646   3,234   1,511   1,482   2,993   1,487   1,397   5,877  11  11  8  11 
Livestock  924   961   1,885   850   837   1,686   886   889   3,462  15  16  12  16 
Companion Animal  664   685   1,349   661   645   1,307   601   508   2,415  6  6  3  4 
Other Revenues (9)  303   110   413   258   222   479   227   185   891  -50  -3  -14  7 

 

*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 and $2,370 million in the first and second quarter of 2025, respectively, and $3,424 million and $3,656 million in the first and second 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 and $704 million in the first and second quarter of 2025, respectively, and $745 million and $715 million in the first and second quarter of 2024. 

(8) Includes Pharmaceutical products not individually shown above. 

(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 and $5 million in the first and second quarter of 2025, respectively, and $61 million and $15 million in the first and second 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  June
YTD
  1Q  2Q  June
YTD
  3Q  4Q  Full
Year
  2Q  June
YTD
 
Sales $15,529  $15,806  $31,335  $15,775  $16,112  $31,887  $16,657  $15,624  $64,168   -2%  -2%
                                             
Costs, Expenses and Other                                            
Cost of sales  3,419   3,557   6,976   3,540   3,745   7,285   4,080   3,828   15,193   -5%  -4%
Selling, general and administrative  2,552   2,649   5,202   2,483   2,739   5,221   2,731   2,864   10,816   -3%  0%
Research and development  3,621   4,048   7,669   3,992   3,500   7,492   5,862   4,585   17,938   16%  2%
Restructuring costs  69   560   629   123   80   202   56   51   309   *   * 
Other (income) expense, net  (35)  (7)  (43)  (33)  42   12   (162)  126   (24)  *   * 
Income Before Taxes  5,903   4,999   10,902   5,670   6,006   11,675   4,090   4,170   19,936   -17%  -7%
Income Tax Provision  818   571   1,388   903   545   1,447   929   425   2,803         
Net Income  5,085   4,428   9,514   4,767   5,461   10,228   3,161   3,745   17,133   -19%  -7%
Less: Net Income Attributable to Noncontrolling Interests  6   1   8   5   6   11   4   2   16         
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA $5,079  $4,427  $9,506  $4,762  $5,455  $10,217  $3,157  $3,743  $17,117   -19%  -7%
                                             
Earnings per Common Share Assuming Dilution $2.01  $1.76  $3.77  $1.87  $2.14  $4.02  $1.24  $1.48  $6.74   -18%  -6%
                                             
Average Shares Outstanding Assuming Dilution  2,531   2,513   2,522   2,544   2,544   2,544   2,541   2,537   2,541         
Tax Rate  13.9%  11.4%  12.7%  15.9%  9.1%  12.4%  22.7%  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 SIX MONTHS ENDED JUNE 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 
Second Quarter                            
Cost of sales  $3,745    606    66              672   $3,073 
Selling, general and administrative   2,739    24    31              55    2,684 
Research and development   3,500    20                   20    3,480 
Restructuring costs   80         80              80     
Other (income) expense, net   42    (17)        (49)        (66)   108 
Income Before Taxes   6,006    (633)   (177)   49         (761)   6,767 
Income Tax Provision (Benefit)   545    (129)(3)    (30)(3)    11(3)    (259)(4)    (407)   952 
Net Income   5,461    (504)   (147)   38    259    (354)   5,815 
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   5,455    (504)   (147)   38    259    (354)   5,809 
Earnings per Common Share Assuming Dilution  $2.14    (0.20)   (0.06)   0.02    0.10    (0.14)  $2.28 
                                    
Tax Rate   9.1%                            14.1%
                                    
June YTD                                   
Cost of sales  $7,285    1,069    182              1,251   $6,034 
Selling, general and administrative   5,221    45    36              81    5,140 
Research and development   7,492    36    2              38    7,454 
Restructuring costs   202         202              202     
Other (income) expense, net   12    (21)        (165)        (186)   198 
Income Before Taxes   11,675    (1,129)   (422)   165         (1,386)   13,061 
Income Tax Provision (Benefit)   1,447    (221)(3)    (72)(3)    36(3)    (259)(4)    (516)   1,963 
Net Income   10,228    (908)   (350)   129    259    (870)   11,098 
Net Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   10,217    (908)   (350)   129    259    (870)   11,087 
Earnings per Common Share Assuming Dilution   $4.02    (0.35)   (0.14)   0.05    0.10    (0.34)  $4.36 
                                    
Tax Rate   12.4%                            15.0%

 

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. 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 and accelerated depreciation 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

SECOND QUARTER 2025

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3a

 

   Global   U.S.   International 
   2Q 2025   2Q 2024   % Change   2Q 2025   2Q 2024   % Change   2Q 2025   2Q 2024   % Change 
TOTAL SALES (1)   $15,806   $16,112    -2   $8,836   $7,876    12   $6,969   $8,236    -15 
PHARMACEUTICAL   14,050    14,408    -2    8,328    7,399    13    5,722    7,009    -18 
Oncology                                             
Keytruda   7,956    7,270    9    4,749    4,412    8    3,207    2,858    12 
Alliance Revenue – Lynparza (2)    370    317    17    174    153    14    195    165    19 
Alliance Revenue – Lenvima (2)    265    249    6    183    177    3    83    73    14 
Welireg   162    126    29    138    116    19    24    10    155 
Alliance Revenue – Reblozyl (3)    107    90    19    88    75    18    19    15    24 
Vaccines (4)                                             
Gardasil/Gardasil 9   1,126    2,478    -55    545    536    2    581    1,941    -70 
ProQuad/M-M-R II/Varivax   609    617    -1    481    490    -2    128    127    1 
Vaxneuvance   229    189    21    136    99    38    93    90    3 
Capvaxive   129         -    129         -                
RotaTeq   121    163    -26    60    107    -44    61    56    9 
Pneumovax 23   38    59    -36    5    11    -57    33    48    -31 
Hospital Acute Care                                             
Bridion   461    455    1    411    351    17    50    104    -52 
Prevymis   228    188    21    115    90    27    113    98    16 
Dificid   96    92    5    83    79    4    13    12    8 
Zerbaxa   74    62    21    45    33    35    29    28    5 
Cardiovascular                                             
Winrevair   336    70    *    323    70    *    12         - 
Alliance Revenue - Adempas/Verquvo (5)    123    106    16    108    98    10    15    8    89 
Adempas (6)    80    72    10                   80    72    10 
Virology                                             
Isentress/Isentress HD   86    89    -3    48    43    13    38    46    -18 
Delstrigo   83    60    40    14    14    -5    70    45    55 
Lagevrio   83    110    -25    30    15    103    52    95    -45 
Pifeltro   41    39    5    25    27    -4    16    12    26 
Neuroscience                                             
Belsomra   40    53    -24    18    19    -1    21    34    -37 
Immunology                                             
Simponi        172    -100                        172    -100 
Remicade        35    -100                        35    -100 
Diabetes (7)                                             
Januvia   372    405    -8    216    177    22    155    227    -32 
Janumet   251    224    12    68    17    *    184    208    -12 
Other Pharmaceutical (8)   584    618    -6    136    190    -28    450    430    5 
ANIMAL HEALTH   1,646    1,482    11    499    455    9    1,147    1,027    12 
Livestock   961    837    15    190    168    13    771    669    15 
Companion Animal   685    645    6    309    287    8    376    358    5 
Other Revenues (9)   110    222    -50    9    22    -59    100    200    -50 

 

*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 $2,370 million and $3,656 million on a global basis in the second 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 $704 million and $715 million on a global basis in the second quarter of 2025 and 2024, respectively.

 

(8) Includes Pharmaceutical products not individually shown above.

 

(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 $5 million and $15 million in the second quarter of 2025 and 2024, respectively.        

 

 

 

 

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

FRANCHISE / KEY PRODUCT SALES

JUNE YEAR-TO-DATE 2025

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3b

 

   Global   U.S.   International 
   June YTD
2025
   June YTD
2024
   % Change   June YTD
2025
   June YTD
2024
   % Change   June YTD
2025
   June YTD
2024
   % Change 
TOTAL SALES (1)   $31,335   $31,887    -2   $17,359   $15,354    13   $13,977   $16,533    -15 
PHARMACEUTICAL   27,688    28,415    -3    16,254    14,336    13    11,434    14,079    -19 
Oncology                                             
Keytruda   15,161    14,217    7    9,057    8,531    6    6,104    5,686    7 
Alliance Revenue – Lynparza (2)   682    609    12    319    288    11    363    321    13 
Alliance Revenue – Lenvima (2)   523    504    4    368    349    5    155    155    - 
Welireg   300    211    42    261    194    35    39    17    130 
Alliance Revenue – Reblozyl (3)   226    161    40    189    133    42    37    28    34 
Vaccines (4)                                             
Gardasil/Gardasil 9   2,453    4,727    -48    1,082    1,024    6    1,371    3,702    -63 
ProQuad/M-M-R II/Varivax   1,148    1,187    -3    903    928    -3    245    259    -6 
Vaxneuvance   459    408    13    275    260    6    184    148    25 
RotaTeq   349    379    -8    225    257    -12    125    123    2 
Capvaxive   236         -    235         -    1         - 
Pneumovax 23   79    120    -35    3    17    -82    76    103    -27 
Hospital Acute Care                                             
Bridion   902    895    1    789    680    16    113    215    -47 
Prevymis   436    362    20    217    165    32    219    197    11 
Dificid   179    165    8    155    147    5    24    17    39 
Zerbaxa   145    118    23    87    67    31    57    51    12 
Cardiovascular                                             
Winrevair   615    70    *    591    70    *    24         - 
Alliance Revenue - Adempas/Verquvo (5)   229    203    12    205    188    9    23    16    50 
Adempas (6)   147    142    4                   147    142    4 
Virology                                             
Lagevrio   185    460    -60    66    60    10    119    400    -70 
Isentress/Isentress HD   176    200    -12    99    93    7    77    107    -28 
Delstrigo   150    116    30    29    26    10    121    89    36 
Pifeltro   86    81    6    57    56    2    29    25    14 
Neuroscience                                             
Belsomra   90    99    -9    31    33    -5    58    66    -12 
Immunology                                             
Simponi        356    -100                        356    -100 
Remicade        74    -100                        74    -100 
Diabetes (7)                                             
Januvia   921    824    12    561    361    55    360    463    -22 
Janumet   498    475    5    133    55    140    366    420    -13 
Other Pharmaceutical (8)   1,313    1,252    5    317    354    -10    997    899    11 
ANIMAL HEALTH   3,234    2,993    8    1,001    929    8    2,233    2,064    8 
Livestock   1,885    1,686    12    384    334    15    1,501    1,352    11 
Companion Animal   1,349    1,307    3    617    595    4    732    712    3 
Other Revenues (9)   413    479    -14    104    89    17    310    390    -21 

 

*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 $4,977 million and $7,080 million on a global basis for June 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 $1,580 million and $1,461 million on a global basis for June YTD 2025 and 2024, respectively.

 

(8) Includes Pharmaceutical products not individually shown above.

 

(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 $100 million and $76 million on a global basis for June 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   June YTD   1Q   2Q   June YTD   3Q   4Q   Full Year   2Q   June YTD 
TOTAL PHARMACEUTICAL  $13,638   $14,050   $27,688   $14,006   $14,408   $28,415   $14,943   $14,042   $57,400    -2    -3 
United States   7,927    8,328    16,254    6,936    7,399    14,336    8,227    7,728    30,290    13    13 
% Pharmaceutical Sales   58.1%   59.3%   58.7%   49.5%   51.4%   50.5%   55.1%   55.0%   52.8%          
Europe (1)   2,384    2,551    4,935    2,555    2,572    5,128    2,620    2,498    10,246    -1    -4 
% Pharmaceutical Sales   17.5%   18.2%   17.8%   18.2%   17.9%   18.0%   17.5%   17.8%   17.9%          
Japan   651    604    1,255    802    664    1,466    919    813    3,199    -9    -14 
% Pharmaceutical Sales   4.8%   4.3%   4.5%   5.7%   4.6%   5.2%   6.2%   5.8%   5.6%          
Latin America   589    654    1,243    601    661    1,262    730    680    2,672    -1    -2 
% Pharmaceutical Sales   4.3%   4.7%   4.5%   4.3%   4.6%   4.4%   4.9%   4.8%   4.7%          
Asia Pacific (other than China and Japan)   535    609    1,144    580    595    1,175    669    612    2,457    2    -3 
% Pharmaceutical Sales   3.9%   4.3%   4.1%   4.1%   4.1%   4.1%   4.5%   4.4%   4.3%          
China (2)   668    407    1,075    1,744    1,790    3,534    996    864    5,394    -77    -70 
% Pharmaceutical Sales   4.9%   2.9%   3.9%   12.5%   12.4%   12.4%   6.7%   6.2%   9.4%          
Eastern Europe/Middle East/Africa   435    451    886    395    353    747    400    348    1,495    28    19 
% Pharmaceutical Sales   3.2%   3.2%   3.2%   2.8%   2.4%   2.6%   2.7%   2.5%   2.6%          
Canada   125    135    261    138    143    281    133    144    558    -6    -7 
% Pharmaceutical Sales   0.9%   1.0%   0.9%   1.0%   1.0%   1.0%   0.9%   1.0%   1.0%          
Other   324    311    635    255    231    486    249    355    1,089    35    31 
% Pharmaceutical Sales   2.4%   2.1%   2.4%   1.9%   1.6%   1.8%   1.5%   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 and $0 in the first and second 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

 

   2Q25   2Q24   June YTD
2025
   June YTD
2024
 
Interest income  $(69)  $(69)  $(178)  $(141)
Interest expense   305    310    618    613 
Exchange losses   78    60    167    144 
Income from investments in equity securities, net (1)    (100)   (56)   (189)   (200)
Net periodic defined benefit plan (credit) cost other than service cost   (152)   (159)   (300)   (319)
Other, net   (69)   (44)   (161)   (85)
Total  $(7)  $42   $(43)  $12 

 

(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.