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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) August 4, 2026 (August 4, 2026)

 

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 August 4, 2026, regarding earnings for the second quarter of 2026, 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 August 4, 2026, regarding earnings for the second quarter of 2026
   
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: August 4, 2026 By: /s/ Kelly E. W. Grez
    Kelly E. W. Grez
    Corporate Secretary

 

 

 

EX-99.1 2 tm2621496d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

- 1 -

 

News Release
   

 

Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2026 Financial Results; Highlights Key Regulatory and Clinical Milestones Across Broad, Diverse Pipeline

 

Sales Growth Reflects Continued Strength in Oncology, Including Initial Uptake of KEYTRUDA QLEX, and Animal Health, Plus Contributions From Launches Such as WINREVAIR

 

Financial Highlights

 

- Total Worldwide Sales Were $16.6 Billion (5% Growth; 4% Growth ex-FX)
o KEYTRUDA/KEYTRUDA QLEX1 Sales Were $8.4 Billion (5% Growth; 4% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $463 Million
o WINREVAIR Sales Were $588 Million (75% Growth; 75% Growth ex-FX)
o Animal Health Sales Were $1.8 Billion (8% Growth; 5% Growth ex-FX)
- GAAP Loss per Share Was $0.54; Non-GAAP Loss per Share Was $0.13; GAAP and Non-GAAP Loss per Share Include a Charge of $2.31 per Share for the Acquisition of Terns

 

Pipeline & Portfolio Highlights

 

- Received U.S. FDA Approval for LIPFENDRA (enlicitide), the First and Only Once-Daily Oral PCSK9 Inhibitor To Reduce LDL-C in Adults With Hypercholesterolemia
- Announced Positive Data From TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (sac-TMT) in Certain Patients With Advanced or Recurrent Endometrial Cancer
- Announced Positive Phase 3 Results From Once-Weekly Investigational Oral HIV Treatment Regimen of Islatravir and Lenacapavir, in Collaboration With Gilead

 

Full-Year 2026 Financial Outlook

 

- Narrows and Raises Expected Worldwide Sales Range To Be Between $66.3 Billion and $67.3 Billion
- Now Expects Non-GAAP EPS To Be Between $2.66 and $2.76; Outlook Includes Charges of $2.43 per Share for the Acquisition of Terns, Comprised of a One-Time Charge of $2.31 per Share as Well as Costs of Approximately $0.12 per Share To Finance the Acquisition and Advance MK-4208 (Formerly TERN-701)

 

 

1 Available in some markets as KEYTRUDA SC.

 

 

- 2 -

 

RAHWAY, N.J., Aug. 4, 2026 – 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 2026.

 

“We continued to make substantial progress across our business this quarter, driven by strong execution and growing contributions from new product launches,” said Robert M. Davis, chairman and chief executive officer. “The FDA approval of LIPFENDRA is an exciting moment for our company and for patients, marking the latest milestone in our nearly 70-year legacy in cardiovascular disease. Together with key regulatory and clinical advances across oncology, HIV and immunology, this achievement reflects the strength of our pipeline and portfolio transformation as we bring forward the next wave of innovation. I am confident in the ongoing execution of our strategy as we deliver for patients and further enhance our long-term growth trajectory.”

 

Financial Summary

 

      Second Quarter  
$ in millions, except EPS amounts     2026       2025       Change       Change Ex-
Exchange
 
Sales   $ 16,607     $ 15,806       5 %     4 %
GAAP net (loss) income2     (1,335 )     4,427       N/M       N/M  
Non-GAAP net (loss) income that excludes certain items2,3*     (330 )     5,366       N/M       N/M  
GAAP EPS     (0.54 )     1.76       N/M       N/M  
Non-GAAP EPS that excludes certain items3*     (0.13 )     2.13       N/M       N/M  

 

*Refer to table on page 7.

N/M - Not meaningful

 

For the second quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $0.54 and non-GAAP loss per share was $0.13. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Terns Pharmaceuticals, Inc. (Terns) of $2.31 per share. Both GAAP and non-GAAP EPS in the second quarter of 2025 include a charge of $0.07 per share for an upfront payment related to a license agreement with Jiangsu Hengrui Pharmaceutical Co., Ltd. (Hengrui Pharma).

 

Non-GAAP EPS excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as 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 reserve adjustments.

 

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

 

 

2 Net (loss) income attributable to the Company.

3 The Company is providing certain 2026 and 2025 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     2026       2025       Change       Change Ex-
Exchange
    Commentary
Total Sales   $ 16,607     $ 15,806       5 %     4 %    
Pharmaceutical     14,760       14,050       5 %     4 %   Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by a decline in diabetes.
KEYTRUDA/ KEYTRUDA QLEX     8,366       7,956       5 %     4 %   Growth primarily driven by strong global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC), cervical cancer, head and neck cancer and bladder cancer, as well as higher global demand in metastatic indications, including urothelial cancer. Sales of KEYTRUDA QLEX were $463 million.
GARDASIL/GARDASIL 9     1,169       1,126       4 %     3 %   Increase primarily due to higher demand in Asia Pacific and Europe, as well as favorable timing of tenders in Europe, partially offset by lower demand in certain other international markets.
PROQUAD, M-M-R II and VARIVAX     592       609       -3 %     -3 %   Decrease primarily reflects lower demand in the U.S., partially offset by higher net pricing in the U.S., higher demand in Europe and favorable private-sector purchasing patterns for M-M-R II in the U.S.
WINREVAIR     588       336       75 %     75 %   Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe.
BRIDION     497       461       8 %     8 %   Growth primarily due to higher demand and net pricing in the U.S.
JANUVIA/JANUMET     429       623       -31 %     -31 %   Decline primarily due to lower demand and net pricing in the U.S. due to competition, as well as lower demand in China and most other international markets due to ongoing generic competition.
Lynparza*     365       370       -1 %     -2 %   Relatively flat compared with prior year.
PREVYMIS     295       228       29 %     28 %   Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications.
Lenvima*     283       265       7 %     6 %   Growth primarily due to higher demand in the U.S., partially offset by lower net pricing.

 

 

- 4 -

 

      Second Quarter      
$ in millions     2026       2025       Change       Change Ex-
Exchange
    Commentary
WELIREG     271       162       67 %     67 %   Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan, as well as favorable wholesaler purchasing patterns in the U.S.
OHTUVAYRE     204       -       -       -     Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc. Includes a benefit from the timing of specialty pharmacy purchases in the U.S.
CAPVAXIVE     184       129       42 %     40 %   Increase primarily driven by launch uptake in several international markets, particularly in Asia Pacific and Europe, as well as in the U.S.
VAXNEUVANCE     148       229       -35 %     -36 %   Decline primarily due to favorable prior period public-sector activity in the U.S., which increased sales in that period, as well as lower demand in the U.S. and in most international markets in the current period due to competitive pressure.
LAGEVRIO     5       83       -95 %     -95 %   Decline largely due to lower demand in Japan and the U.S.
Animal Health     1,775       1,646       8 %     5 %   Growth attributable to both Livestock and Companion Animal product portfolios.
Livestock     1,041       961       8 %     6 %   Growth primarily driven by higher demand for ruminant and poultry products.
Companion Animal     734       685       7 %     5 %   Growth primarily due to new product launches. Sales of BRAVECTO line of products were $359 million and $335 million in the current and prior-year quarters, respectively, which represents an increase of 7%, or 4% excluding impact of foreign exchange.
Other Revenues**     72       110       -35 %     -34 %   Decline primarily due to 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.

 

 

- 5 -

 

Second-Quarter Expense 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 2026                              
Cost of sales   $ 4,395     $ 1,067     $ 184     $ -     $ 3,144  
Selling, general and administrative     2,904       17       -       -       2,887  
Research and development     9,741       6       (1 )     -       9,736  
Restructuring costs     151       -       151       -       -  
Other (income) expense, net     99       -       -       (191 )     290  
                                         
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  

 

GAAP Expense, EPS and Related Information

 

Gross margin was 73.5% for the second quarter of 2026 compared with 77.5% for the second quarter of 2025. The decrease was primarily due to higher amortization of intangible assets and inventory write-downs.

 

Selling, general and administrative (SG&A) expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches.

 

Research and development (R&D) expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone Life Sciences (Blackstone). R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma.

 

Other (income) expense, net, was $99 million of expense in the second quarter of 2026 compared with $7 million of income in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities.

 

 

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, licensing arrangements and asset acquisitions, and recognition of fair value step-up to inventories for asset acquisitions.

 

 

- 6 -

 

The income tax provision for the second quarter of 2026 was $654 million on a pretax loss of $683 million, resulting in an effective income tax rate of (95.9)%. This effective income tax rate includes a 108.9 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded.

 

GAAP loss per share was $0.54 for the second quarter of 2026 compared with earnings per share of $1.76 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma.

 

Non-GAAP Expense, EPS and Related Information

 

Non-GAAP gross margin was 81.1% for the second quarter of 2026 compared with 82.2% for the second quarter of 2025. The decrease was primarily due to higher inventory write-downs.

 

Non-GAAP SG&A expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches.

 

Non-GAAP R&D expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone. R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma.

 

Non-GAAP other (income) expense, net, was $290 million of expense in the second quarter of 2026 compared with $54 million of expense in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense.

 

The non-GAAP income tax provision for the second quarter of 2026 was $882 million on pretax income of $550 million, resulting in a non-GAAP effective income tax rate of 160.3%. This effective income tax rate includes a 146.2 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded.

 

Non-GAAP loss per share was $0.13 for the second quarter of 2026 compared with earnings per share of $2.13 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma.

 

 

- 7 -

 

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

      Second Quarter  
$ in millions, except EPS amounts     2026       2025  
EPS                
GAAP EPS   $ (0.54 )   $ 1.76  
Difference     0.41       0.37  
Non-GAAP EPS that excludes items listed below3   $ (0.13 )   $ 2.13  
                 
Net (Loss) Income                
GAAP net (loss) income2   $ (1,335 )   $ 4,427  
Difference     1,005       939  
Non-GAAP net (loss) income that excludes items listed below2,3   $ (330 )   $ 5,366  
                 
Excluded Items:                
Acquisition- and divestiture-related costs4   $ 1,090     $ 594  
Restructuring costs     334       779  
Income from investments in equity securities     (191 )     (61 )
Increase to net loss / decrease to net income before taxes     1,233       1,312  
Estimated income tax benefit5     (228 )     (373 )
Increase to net loss / decrease to net income   $ 1,005     $ 939  

 

Pipeline and Portfolio Highlights

 

In the second quarter, the Company achieved key regulatory milestones across the portfolio while continuing to advance its broad and diverse pipeline.

 

· Oncology:
o U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX, each with WELIREG, for the adjuvant treatment of certain patients with clear cell renal cell carcinoma (ccRCC), based on Phase 3 LITESPARK-022 trial.
§ Approvals represent first approved combination of a PD-1 and hypoxia-inducible factor-2 alpha inhibitor for these patients.
o In July, FDA approved expanded use of KEYTRUDA and KEYTRUDA QLEX, each with Padcev, as treatment before and after surgery for adult patients with muscle-invasive bladder cancer (MIBC), including cisplatin eligible patients based on Phase 3 KEYNOTE-B15 trial; the expansion builds upon prior approval of this regimen for cisplatin ineligible patients based on Phase 3 KEYNOTE-905 trial.
o FDA approved KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of PD-L1 positive (Combined Positive Score [CPS] ≥10) advanced TNBC, based on Phase 3 KEYNOTE-D19/ASCENT-04 trial.
o FDA granted Breakthrough Therapy designation (BTD) for calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA, for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1 (tumor proportion score [TPS] ≥1%).

 

 

5 Includes the estimated income tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments for all periods presented. Amount in the second quarter of 2025 also includes a $146 million benefit primarily resulting from favorable audit reserve adjustments.

 

 

- 8 -

 

o Announced that Phase 3 TroFuse-005 trial evaluating sac-TMT, an investigational anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. 
§ First Phase 3 results from the Company’s broad sac-TMT clinical development program, which includes 17 ongoing global Phase 3 trials across multiple tumor types.
o At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, new research was presented across over 25 types of cancer, reinforcing long-term impact of KEYTRUDA and momentum in the Company’s rapidly advancing oncology pipeline, including:
§ Five-year follow-up data from Phase 2b KEYNOTE-942 trial, in collaboration with Moderna, underscoring continued potential of intismeran autogene (mRNA-4157/V940) in combination with KEYTRUDA for patients with stage III/IV melanoma following complete resection.
§ Data from Phase 3 OptiTROP-Lung05 trial, led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA in China, adding to ongoing research of novel treatment approaches for patients with NSCLC.
§ Results from final analysis of KEYNOTE-522 evaluating KEYTRUDA in combination with chemotherapy, reporting a continued survival benefit for patients with high-risk early-stage TNBC.

 

· Vaccines and Infectious Diseases:
o In July, presented new data for daily and weekly options across HIV treatment and prevention pipeline at 26th International AIDS Conference (AIDS 2026). Hosted HIV investor event to highlight these data.
§ In collaboration with Gilead, presented first Phase 3 results for islatravir/lenacapavir (ISL/LEN), an investigational oral once-weekly single-tablet HIV treatment regimen, which maintained virological suppression in adults with HIV who switched antiretroviral therapy. ISL/LEN has the potential to be the first approved oral, once-weekly HIV treatment.
§ Presented first results from a Phase 2b study evaluating switch to investigational once-weekly oral islatravir and ulonivirine (ISL/ULO) in adults with virologically suppressed HIV-1.
o Received regulatory approvals in Japan and China for ENFLONSIA for the prevention of RSV lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season.

 

 

- 9 -

 

· Cardiometabolic and Respiratory:
o In July, FDA approved LIPFENDRA (enlicitide), the first and only once-daily oral PCSK9 inhibitor, as an adjunct to diet and exercise, to reduce LDL-C in adults with hypercholesterolemia, based on two Phase 3 trials from the CORALreef clinical program: CORALreef Lipids and CORALreef HeFH.
§ At week 24, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively.

 

· Immunology:
Announced positive topline results from Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active ulcerative colitis (UC).
o Initial topline results from primary analyses of two Phase 2 studies evaluating tulisokibart:
§ In hidradenitis suppurativa (HS), the study met its primary and key secondary endpoints. Full results will be shared at an upcoming medical meeting.
§ In systemic sclerosis-associated interstitial lung disease (SSc-ILD), the study did not meet its primary endpoint and will be discontinued. No new safety concerns were identified.

 

· Business Development:
o Completed acquisition of Terns for $6.8 billion.
§ Added MK-4208, a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor recently granted BTD by the FDA for the treatment of certain adults with Philadelphia chromosome-positive chronic myeloid leukemia.

 

 

- 10 -

 

Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.*

 

Oncology FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With WELIREG, for Adjuvant Treatment of Certain Patients With ccRCC; Based on Results From Phase 3 LITESPARK-022 Trial
FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Treatment Before and After Surgery for Adults With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial, Combined With Previous Approvals Based on Phase 3 KEYNOTE-905 Trial
FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Trodelvy, as First-Line Treatment of PD-L1+ Advanced TNBC; Based on Results From Phase 3 KEYNOTE-D19/ASCENT-04 Trial
European Commission Approved KEYTRUDA Plus Padcev as First PD-1 Inhibitor Plus ADC Regimen for Adults With Cisplatin-Ineligible Resectable MIBC; Based on Results From Phase 3 KEYNOTE-905 Trial
FDA Granted BTD for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients With Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC
The Company Announced TroFuse-005 Trial Evaluating Sac-TMT Met Primary Endpoints of OS and PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer  
The Company and Moderna Presented 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection at ASCO 2026
KEYTRUDA as Monotherapy Significantly Improved PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient Tumors Compared to Chemotherapy; Results From Phase 3 KEYNOTE-C93 Trial
The Company Highlighted New Long-Term Data and Advancements Across Broad Oncology Portfolio and Pipeline Research at ASCO 2026
The Company Completed Acquisition of Terns
Vaccines and Infectious Diseases The Company, in Collaboration With Gilead, Announced That the Once-Weekly Investigational Oral HIV Treatment Regimen of Islatravir and Lenacapavir (ISL/LEN) Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy
The Company Presented New Data on Daily, Weekly and Monthly Options Across its HIV Treatment and Prevention Pipeline at AIDS 2026
The Company Announced Initial Access Plans for Alimatravir (MK-8527), Its Investigational Once-Monthly Oral Pre-Exposure Prophylaxis in Phase 3 Development; Multi-Faceted Strategy Aims To Enable Rapid, Broad and Sustainable Access to Alimatravir, if Approved, in Low- And Middle-Income Countries
The Company Announced New Agreement With AIDS Drug Assistance Program Crisis Task Force To Improve Access and Care for People Living With HIV
FDA Approved an Additional Indication for CAPVAXIVE in Children and Adolescents Aged 2 Through 17 at Increased Risk for Pneumococcal Disease; Based on Results From Phase 3 STRIDE-13 Trial
Cardiometabolic and Respiratory FDA Approved LIPFENDRA, the First and Only Once-Daily Oral PCSK9 Inhibitor To Reduce LDL-C in Adults With Hypercholesterolemia; Based on Results From CORALreef Lipids and CORALreef HeFH Trials
Immunology Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active UC
Animal Health The Company’s Animal Health Business Completed Acquisition of TARGAN, Broadening Its Commercial Poultry Portfolio Through TARGAN’s Innovative High-Speed Biodevice Technology

*References in the above news release titles have been modified for the purpose of this announcement.

 

 

- 11 -

 

Upcoming Investor Event

 

The Company will hold an Oncology Investor Event to coincide with the European Society for Medical Oncology Congress 2026 on Monday, Oct. 26, 2026, at 6 p.m. CET / 1 p.m. EDT, during which senior management will provide an update on the Company’s oncology strategy and program. The event will take place in Madrid, Spain, and will be accessible via live audio webcast at this weblink.

 

Full-Year 2026 Financial Outlook

 

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

 

    Full Year 2026
    Updated   Prior
Sales*   $66.3 billion to $67.3 billion   $65.8 billion to $67.0 billion
Non-GAAP Gross margin3   Approximately 81%   Approximately 82%
Non-GAAP Operating expenses3**   $42.0 billion to $42.7 billion   $36.0 billion to $36.8 billion
Non-GAAP Other (income) expense, net3   Approximately $1.4 billion expense   Approximately $1.3 billion expense
Non-GAAP Effective income tax rate3   35.0% to 36.0%   23.5% to 24.5%
Non-GAAP EPS3***   $2.66 to $2.76   $5.04 to $5.16
Share count (assuming dilution)   Approximately 2.48 billion   Approximately 2.48 billion

 

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

**Includes one-time R&D charges of $9.0 billion for the acquisition of Cidara Therapeutics, Inc. (Cidara) and $5.7 billion for the acquisition of Terns. Outlook does not assume any additional significant potential business development transactions.

***Includes one-time charges of $3.62 per share for the acquisition of Cidara and $2.31 per share for the acquisition of Terns.

 

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 income 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 is raising and narrowing the range for its full-year sales outlook and now anticipates full-year 2026 sales to be between $66.3 billion and $67.3 billion, including a positive impact from foreign exchange of approximately 1% at mid-July 2026 exchange rates.

 

The Company now expects the full-year non-GAAP effective income tax rate to be between 35.0% and 36.0%, including the impact of the non-tax deductible one-time charges for the acquisitions of Cidara and Terns.

 

The Company now expects full-year 2026 non-GAAP EPS to be between $2.66 and $2.76, including a positive impact from foreign exchange of approximately $0.15 per share at mid-July 2026 exchange rates. This range includes one-time charges of $9.0 billion, or $3.62 per share, related to the acquisition of Cidara and $5.7 billion, or $2.31 per share, related to the acquisition of Terns. This range also includes costs of approximately $0.12 per share to finance the Terns acquisition and advance MK-4208. The charges related to Terns were not previously included in the outlook. In 2025, non-GAAP EPS of $8.98 was negatively impacted by one-time charges of $0.20 per share in the aggregate related to certain business development transactions.

 

 

- 12 -

 

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 Tuesday, Aug. 4, at 9 a.m. EDT 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.

 

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.

 

 

- 13 -

 

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, 2025 and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

Appendix

 

Generic product names are provided below.

 

Pharmaceutical
BRIDION 
(sugammadex)
CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine)

ENFLONSIA (clesrovimab-cfor)

GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant)
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

JANUMET (sitagliptin and metformin HCl)
JANUVIA (sitagliptin)
KEYTRUDA (pembrolizumab)
KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)

LAGEVRIO (molnupiravir)
Lenvima (lenvatinib)

LIPFENDRA (enlicitide)
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)

VARIVAX (Varicella Virus Vaccine Live)

VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)

WELIREG (belzutifan)
WINREVAIR (sotatercept-csrk)

 

 

- 14 -

 

Animal Health
BRAVECTO
(fluralaner)

 

###

 

 

Media Contacts: Investor Contacts:
   
Michael Levey Peter Dannenbaum
michael.levey@msd.com (732) 594-1579
   
John Cummins Steven Graziano
john.cummins2@msd.com (732) 594-1583

 

 

 

 

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

CONSOLIDATED STATEMENT OF OPERATIONS - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1

 

    GAAP           GAAP        
    2Q26     2Q25     % Change     June YTD
2026
    June YTD
2025
    % Change  
Sales   $ 16,607     $ 15,806       5 %   $ 32,893     $ 31,335       5 %
                                                 
Costs, Expenses and Other                                                
Cost of sales     4,395       3,557       24 %     8,590       6,976       23 %
Selling, general and administrative     2,904       2,649       10 %     5,604       5,202       8 %
Research and development     9,741       4,048       *       22,333       7,669       *  
Restructuring costs     151       560       -73 %     346       629       -45 %
Other (income) expense, net     99       (7 )     *       237       (43 )     *  
(Loss) Income Before Taxes     (683 )     4,999       *       (4,217 )     10,902       *  
Income Tax Provision     654       571               1,363       1,388          
Net (Loss) Income     (1,337 )     4,428       *       (5,580 )     9,514       *  
Less: Net (Loss) Income Attributable to Noncontrolling Interests     (2 )     1               (5 )     8          
Net (Loss) Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   $ (1,335 )   $ 4,427       *     $ (5,575 )   $ 9,506       *  
                                                 
(Loss) Earnings per Common Share Assuming Dilution (1)   $ (0.54 )   $ 1.76       *     $ (2.26 )   $ 3.77       *  
                                                 
Average Shares Outstanding Assuming Dilution (1)     2,470       2,513               2,471       2,522          
Tax Rate     -95.9 %     11.4 %             -32.3 %     12.7 %        

 

* 100% or greater

 

(1) Because the Company recorded a net loss in both the second quarter and first six months of 2026, no potential dilutive common shares were used in the computations of loss per common share assuming dilution as the effects would have been anti-dilutive. 

 

 

 

 

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

THREE AND SIX MONTHS ENDED JUNE 30, 2026 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
    Adjustment
Subtotal
    Non-GAAP  
Second Quarter                                                
Cost of sales   $ 4,395       1,067       184               1,251     $ 3,144  
Selling, general and administrative     2,904       17                       17       2,887  
Research and development     9,741       6       (1 )             5       9,736  
Restructuring costs     151               151               151        
Other (income) expense, net     99                       (191 )     (191 )     290  
Loss Before Taxes     (683 )     (1,090 )     (334 )     191       (1,233 )     550  
Income Tax Provision (Benefit)     654       (219 )(3)     (50 )(3)     41 (3)     (228 )     882  
Net Loss     (1,337 )     (871 )     (284 )     150       (1,005 )     (332 )
Net Loss Attributable to Merck & Co., Inc., Rahway, N.J., USA     (1,335 )     (871 )     (284 )     150       (1,005 )     (330 )
Loss per Common Share Assuming Dilution (4)   $ (0.54 )     (0.35 )     (0.12 )     0.06       (0.41 )   $ (0.13 )
                                                 
Tax Rate     -95.9 %                                     160.3 %
                                                 
June YTD                                                
Cost of sales   $ 8,590       2,081       421               2,502     $ 6,088  
Selling, general and administrative     5,604       49                       49       5,555  
Research and development     22,333       6       33               39       22,294  
Restructuring costs     346               346               346        
Other (income) expense, net     237                       (371 )     (371 )     608  
Loss Before Taxes     (4,217 )     (2,136 )     (800 )     371       (2,565 )     (1,652 )
Income Tax Provision (Benefit)     1,363       (421 )(3)     (135 )(3)     80 (3)     (476 )     1,839  
Net Loss     (5,580 )     (1,715 )     (665 )     291       (2,089 )     (3,491 )
Net Loss Attributable to Merck & Co., Inc., Rahway, N.J., USA     (5,575 )     (1,715 )     (665 )     291       (2,089 )     (3,486 )
Loss per Common Share Assuming Dilution (4)   $ (2.26 )     (0.70 )     (0.27 )     0.12       (0.85 )   $ (1.41 )
                                                 
Tax Rate     -32.3 %                                     -111.3 %

 

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, as well as the recognition of fair value step-up of inventories related to the 2025 Verona Pharma plc acquisition. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. 

 

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

 

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

 

(4) Because the Company recorded a net loss in both the second quarter and first six months of 2026, no potential dilutive common shares were used in the computations of loss per common share assuming dilution as the effects would have been anti-dilutive.  

 

 

 

 

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

FRANCHISE / KEY PRODUCT SALES

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3

 

    2026    2025   2Q    June YTD  
    1Q   2Q   June YTD   1Q   2Q   June YTD   3Q   4Q   Full Year   Nom %   Ex-Exch %   Nom %   Ex-Exch %  
TOTAL SALES (1)   $ 16,286   $ 16,607   $ 32,893   $ 15,529   $ 15,806   $ 31,335   $ 17,276   $ 16,400   $ 65,011     5     4     5     3  
PHARMACEUTICAL     14,349     14,760     29,109     13,638     14,050     27,688     15,611     14,843     58,142     5     4     5     3  
Oncology                                                                                
Keytruda     7,906     7,904     15,810     7,205     7,956     15,161     8,142     8,337     31,641     -1     -2     4     2  
Keytruda Qlex     128     463     590                       5     35     40     -     -     -     -  
Alliance Revenue – Lynparza (2)     341     365     706     312     370     682     379     389     1,450     -1     -2     4     2  
Alliance Revenue – Lenvima (2)     256     283     539     258     265     523     258     272     1,053     7     6     3     2  
Welireg     199     271     470     137     162     300     196     220     716     67     67     57     56  
Alliance Revenue – Reblozyl (3)     148     122     270     119     107     226     136     164     525     15     15     20     20  
Vaccines (4)                                                                                
Gardasil/Gardasil 9     1,069     1,169     2,238     1,327     1,126     2,453     1,749     1,031     5,233     4     3     -9     -10  
ProQuad/M-M-R II/Varivax     538     592     1,130     539     609     1,148     684     619     2,451     -3     -3     -2     -3  
Vaxneuvance     202     148     350     230     229     459     226     140     825     -35     -36     -24     -26  
RotaTeq     206     134     340     228     121     349     204     119     673     10     9     -3     -4  
Capvaxive     142     184     325     107     129     236     244     279     759     42     40     38     36  
Enflonsia     1     2     3                       79     21     100     -     -     -     -  
Cardiometabolic & Respiratory                                                                                
Winrevair     525     588     1,114     280     336     615     360     467     1,443     75     75     81     81  
Ohtuvayre     131     204     335                             178     178     -     -     -     -  
Alliance Revenue - Adempas/Verquvo (5)     109     126     235     106     123     229     112     129     470     3     3     3     3  
Adempas (6)     78     78     156     68     80     147     82     83     312     -2     -4     6     1  
Infectious Diseases                                                                                
Bridion     472     497     969     441     461     902     439     499     1,841     8     8     7     7  
Prevymis     272     295     568     208     228     436     266     275     978     29     28     30     27  
Delstrigo     75     101     176     67     83     150     77     79     306     21     17     17     10  
Zerbaxa     82     77     159     70     74     145     81     87     312     4     2     10     8  
Isentress/Isentress HD     59     60     119     90     86     176     82     67     325     -30     -31     -32     -33  
Dificid     34     22     56     83     96     179     43     25     247     -77     -77     -69     -69  
Lagevrio     28     5     32     102     83     185     138     57     380     -95     -95     -82     -83  
Diabetes                                                                                
Januvia     367     258     625     549     372     921     382     302     1,604     -31     -30     -32     -32  
Janumet     207     171     378     247     251     498     243     199     940     -32     -33     -24     -25  
Other Pharmaceutical (7)     774     641     1,416     865     703     1,568     1,004     770     3,340     -9     -9     -10     -11  
ANIMAL HEALTH     1,791     1,775     3,566     1,588     1,646     3,234     1,615     1,505     6,354     8     5     10     6  
Livestock     1,064     1,041     2,105     924     961     1,885     1,023     987     3,896     8     6     12     7  
Companion Animal     727     734     1,461     664     685     1,349     592     518     2,458     7     5     8     4  
Other Revenues (8)     146     72     218     303     110     413     50     52     515     -35     -34     -47     -6  

 

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.
(1) Only select products are shown.          
(2) Alliance Revenue represents the Company's share of profits, which are product sales net of cost of sales and commercialization costs.          
(3) Alliance Revenue represents royalties.
(4) Total Vaccines sales were $2,314 million and $2,361 million in the first and second quarter of 2026, respectively, and $2,607 million and $2,370 million in the first and second quarter of 2025, 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) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $161 million and $10 million in the first and second quarter of 2026, respectively, and $44 million and $43 million in the first and second quarter of 2025, respectively.
(8) 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 milestone payments for out-licensed products were $132 million and $0 million in the first and second quarter of 2026, respectively, and $95 million and $5 million in the first and second quarter of 2025, respectively.

 

 

EX-99.2 3 tm2621496d1_ex99-2.htm EXHIBIT 99.2

 

Exhibit 99.2

 

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

CONSOLIDATED STATEMENT OF OPERATIONS - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1a

 

    2026     2025     % Change  
    1Q     2Q     June YTD     1Q     2Q     June YTD     3Q     4Q     Full Year     2Q     Full Year  
Sales   $ 16,286     $ 16,607     $ 32,893     $ 15,529     $ 15,806     $ 31,335     $ 17,276     $ 16,400     $ 65,011       5 %     5 %
                                                                                         
Costs, Expenses and Other                                                                                        
Cost of sales     4,195       4,395       8,590       3,419       3,557       6,976       3,855       5,551       16,382       24 %     23 %
Selling, general and administrative     2,700       2,904       5,604       2,552       2,649       5,202       2,633       2,898       10,733       10 %     8 %
Research and development     12,592       9,741       22,333       3,621       4,048       7,669       4,234       3,886       15,789       *       *  
Restructuring costs     195       151       346       69       560       629       47       213       889       -73 %     -45 %
Other (income) expense, net     138       99       237       (35 )     (7 )     (43 )     (238 )     432       151       *       *  
(Loss) Income Before Taxes     (3,534 )     (683 )     (4,217 )     5,903       4,999       10,902       6,745       3,420       21,067       *       *  
Income Tax Provision     709       654       1,363       818       571       1,388       958       458       2,804                  
Net (Loss) Income     (4,243 )     (1,337 )     (5,580 )     5,085       4,428       9,514       5,787       2,962       18,263       *       *  
Less: Net (Loss) Income Attributable to Noncontrolling Interests     (3 )     (2 )     (5 )     6       1       8       2       (1 )     9                  
Net (Loss) Income Attributable to Merck & Co., Inc., Rahway, N.J., USA   $ (4,240 )   $ (1,335 )   $ (5,575 )   $ 5,079     $ 4,427     $ 9,506     $ 5,785     $ 2,963     $ 18,254       *       *  
                                                                                         
(Loss) Earnings per Common Share Assuming Dilution (1)   $ (1.72 )   $ (0.54 )   $ (2.26 )   $ 2.01     $ 1.76     $ 3.77     $ 2.32     $ 1.19     $ 7.28       *       *  
                                                                                         
Average Shares Outstanding Assuming Dilution (1)     2,472       2,470       2,471       2,531       2,513       2,522       2,498       2,488       2,507                  
Tax Rate     -20.1 %     -95.9 %     -32.3 %     13.9 %     11.4 %     12.7 %     14.2 %     13.4 %     13.3 %                

 

* 100% or greater

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

 

(1) Because the Company recorded a net loss in both the second quarter and first six months of 2026, no potential dilutive common shares were used in the computations of loss per common share assuming dilution as the effects would have been anti-dilutive.  

 

 

 

 

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 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   $ 3,557       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 reserve adjustments.

 

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA
FRANCHISE / KEY PRODUCT SALES
SECOND QUARTER 2026

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3a

 

    Global   U.S.   International  
    2Q 2026   2Q 2025   % Change   2Q 2026   2Q 2025   % Change   2Q 2026   2Q 2025   % Change  
TOTAL SALES (1)   $ 16,607   $ 15,806     5   $ 9,367   $ 8,836     6   $ 7,240   $ 6,969     4  
PHARMACEUTICAL     14,760     14,050     5     8,827     8,328     6     5,933     5,722     4  
Oncology                                                        
Keytruda     7,904     7,956     -1     4,611     4,749     -3     3,293     3,207     3  
Keytruda Qlex     463           -     395           -     68           -  
Alliance Revenue – Lynparza (2)     365     370     -1     167     174     -4     198     195     2  
Alliance Revenue – Lenvima (2)     283     265     7     194     183     6     90     83     8  
Welireg     271     162     67     214     138     55     57     24     133  
Alliance Revenue – Reblozyl (3)     122     107     15     98     88     11     25     19     31  
Vaccines (4)                                                        
Gardasil/Gardasil 9     1,169     1,126     4     542     545     -1     626     581     8  
ProQuad/M-M-R II/Varivax     592     609     -3     438     481     -9     154     128     20  
Capvaxive     184     129     42     138     129     7     45           -  
Vaxneuvance     148     229     -35     69     136     -50     80     93     -14  
RotaTeq     134     121     10     84     60     39     50     61     -18  
Enflonsia     2           -                       2           -  
Cardiometabolic & Respiratory                                                        
Winrevair     588     336     75     522     323     61     66     12     *  
Ohtuvayre     204           -     204           -                    
Alliance Revenue - Adempas/Verquvo (5)     126     123     3     112     108     4     14     15     -1  
Adempas (6)     78     80     -2                       78     80     -2  
Infectious Diseases                                                        
Bridion     497     461     8     460     411     12     37     50     -25  
Prevymis     295     228     29     147     115     28     148     113     31  
Delstrigo     101     83     21     13     14     -7     88     70     27  
Zerbaxa     77     74     4     44     45     -3     34     29     14  
Isentress/Isentress HD     60     86     -30     36     48     -26     24     38     -36  
Dificid     22     96     -77     11     83     -87     12     13     -11  
Lagevrio     5     83     -95     1     30     -96     3     52     -94  
Diabetes                                                        
Januvia     258     372     -31     149     216     -31     109     155     -30  
Janumet     171     251     -32     28     68     -59     143     184     -22  
Other Pharmaceutical (7)     641     703     -9     150     184     -18     489     520     -6  
ANIMAL HEALTH     1,775     1,646     8     535     499     7     1,240     1,147     8  
Livestock     1,041     961     8     202     190     6     838     771     9  
Companion Animal     734     685     7     333     309     8     402     376     7  
Other Revenues (8)     72     110     -35     5     9     -44     67     100     -33  

 

*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 $2,361 million and $2,370 million on a global basis in the second quarter of 2026 and 2025, 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) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $10 million and $43 million on a global basis in the second quarter of 2026 and 2025, respectively.
(8) 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 milestone payments for out-licensed products were $0 million and $5 million on a global basis in the second quarter of 2026 and 2025, respectively.

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA
FRANCHISE / KEY PRODUCT SALES
JUNE YEAR-TO-DATE 2026

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3b

 

    Global   U.S.   International  
    June YTD
2026
  June YTD
2025
  % Change   June YTD
2026
  June YTD
2025
  % Change   June YTD
2026
  June YTD
2025
  % Change  
TOTAL SALES (1)   $ 32,893   $ 31,335     5   $ 18,532   $ 17,359     7   $ 14,361   $ 13,977     3  
PHARMACEUTICAL     29,109     27,688     5     17,338     16,254     7     11,771     11,434     3  
Oncology                                                        
Keytruda     15,810     15,161     4     9,210     9,057     2     6,600     6,104     8  
Keytruda Qlex     590           -     501           -     89           -  
Alliance Revenue – Lynparza (2)     706     682     4     315     319     -1     391     363     8  
Alliance Revenue – Lenvima (2)     539     523     3     369     368     0     170     155     9  
Welireg     470     300     57     366     261     40     103     39     166  
Alliance Revenue – Reblozyl (3)     270     226     20     226     189     20     45     37     21  
Vaccines (4)                                                        
Gardasil/Gardasil 9     2,238     2,453     -9     1,027     1,082     -5     1,211     1,371     -12  
ProQuad/M-M-R II/Varivax     1,130     1,148     -2     847     903     -6     283     245     16  
Capvaxive     325     236     38     256     235     9     69     1     *  
Vaxneuvance     350     459     -24     192     275     -30     158     184     -14  
RotaTeq     340     349     -3     249     225     11     91     125     -27  
Enflonsia     3           -     -1           -     4           -  
Cardiometabolic & Respiratory                                                        
Winrevair     1,114     615     81     999     591     69     114     24     *  
Ohtuvayre     335           -     335           -                    
Alliance Revenue - Adempas/Verquvo (5)     235     229     3     221     205     8     14     23     -40  
Adempas (6)     156     147     6                       156     147     6  
Infectious Diseases                                                        
Bridion     969     902     7     887     789     12     82     113     -27  
Prevymis     568     436     30     282     217     30     285     219     30  
Delstrigo     176     150     17     23     29     -21     153     121     26  
Zerbaxa     159     145     10     95     87     9     64     57     12  
Isentress/Isentress HD     119     176     -32     71     99     -29     49     77     -37  
Dificid     56     179     -69     35     155     -77     21     24     -10  
Lagevrio     32     185     -82     18     66     -73     15     119     -87  
Diabetes                                                        
Januvia     625     921     -32     401     561     -29     224     360     -38  
Janumet     378     498     -24     96     133     -28     283     366     -23  
Other Pharmaceutical (7)     1,416     1,568     -10     318     408     -22     1,097     1,160     -5  
ANIMAL HEALTH     3,566     3,234     10     1,054     1,001     5     2,512     2,233     12  
Livestock     2,105     1,885     12     414     384     8     1,691     1,501     13  
Companion Animal     1,461     1,349     8     640     617     4     821     732     12  
Other Revenues (8)     218     413     -47     140     104     35     78     310     -75  

 

*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 $4,675 million and $4,977 million on a global basis for June YTD 2026 and 2025, 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) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $171 million and $87 million on a global basis for June YTD 2026 and 2025, respectively.
(8) 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 milestone payments for out-licensed products were $132 million and $100 million on a global basis for June YTD 2026 and 2025, respectively.

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA
PHARMACEUTICAL GEOGRAPHIC SALES
(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3c

 

    2026   2025   % Change  
    1Q   2Q   June YTD   1Q   2Q     June YTD   3Q     4Q   Full Year   2Q   June YTD  
TOTAL PHARMACEUTICAL   $ 14,349   $ 14,760   $ 29,109   $ 13,638   $ 14,050     $ 27,688   $ 15,611     $ 14,843   $ 58,142     5     5  
                                                                         
United States     8,512     8,827     17,338     7,927     8,328       16,254     9,493       8,662     34,409     6     7  
% Pharmaceutical Sales     59.3 %   59.8 %   59.6 %   58.1 %   59.3 %     58.7 %   60.8 %     58.4 %   59.2 %            
Europe (1)     2,725     2,801     5,525     2,384     2,551       4,935     2,675       2,839     10,449     10     12  
% Pharmaceutical Sales     19.0 %   19.0 %   19.0 %   17.5 %   18.2 %     17.8 %   17.1 %     19.1 %   18.0 %            
Latin America     624     636     1,260     589     654       1,243     691       644     2,578     -3     1  
% Pharmaceutical Sales     4.3 %   4.3 %   4.3 %   4.3 %   4.7 %     4.5 %   4.4 %     4.3 %   4.4 %            
Asia Pacific (other than China and Japan)     569     636     1,205     535     609       1,144     593       586     2,323     5     5  
% Pharmaceutical Sales     4.0 %   4.3 %   4.1 %   3.9 %   4.3 %     4.1 %   3.8 %     4.0 %   4.0 %            
Japan     535     558     1,093     651     604       1,255     693       684     2,632     -8     -13  
% Pharmaceutical Sales     3.7 %   3.8 %   3.8 %   4.8 %   4.3 %     4.5 %   4.4 %     4.6 %   4.5 %            
Eastern Europe/Middle East/Africa     413     408     821     435     451       886     365       348     1,598     -10     -7  
% Pharmaceutical Sales     2.9 %   2.8 %   2.8 %   3.2 %   3.2 %     3.2 %   2.3 %     2.3 %   2.7 %            
China     353     368     721     668     407       1,075     377       364     1,816     -9     -33  
% Pharmaceutical Sales     2.5 %   2.5 %   2.5 %   4.9 %   2.9 %     3.9 %   2.4 %     2.5 %   3.1 %            
Canada     137     154     291     125     135       261     134       153     547     14     12  
% Pharmaceutical Sales     1.0 %   1.0 %   1.0 %   0.9 %   1.0 %     0.9 %   0.9 %     1.0 %   0.9 %            
Other     481     372     855     324     311       635     590       563     1,790     20     35  
% Pharmaceutical Sales     3.3 %   2.5 %   2.9 %   2.4 %   2.1 %     2.4 %   3.9 %     3.8 %   3.2 %            

 

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.

 

 

 

 

MERCK & CO., INC., RAHWAY, N.J., USA
OTHER (INCOME) EXPENSE, NET - GAAP
(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 4

 

OTHER (INCOME) EXPENSE, NET          

 

    2Q26     2Q25     June
YTD 2026
    June
YTD 2025
 
Interest income   $ (35 )   $ (69 )   $ (70 )   $ (178 )
Interest expense     525       305       1,004       618  
Exchange losses     37       78       75       167  
Income from investments in equity securities, net (1)     (242 )     (100 )     (411 )     (189 )
Net periodic defined benefit plan (credit) cost other than service cost     (127 )     (152 )     (262 )     (300 )
Other, net     (59 )     (69 )     (99 )     (161 )
Total   $ 99     $ (7 )   $ 237     $ (43 )

 

(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.