Novartis delivered high single-digit sales growth, achieved 40% core margin and further advanced the pipeline in 2025

On February 4, 2026 Novartis reported high single-digit sales growth, achieved 40% core margin and further advanced the pipeline in 2025.

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Commenting on Q4 2025 results, Vas Narasimhan, CEO of Novartis, said:
"Novartis delivered strong performance in 2025, with high single-digit sales growth and core margin expansion despite significant US generic entries. Growth drivers Kisqali, Kesimpta, Pluvicto, Scemblix and Cosentyx continued their strong trajectory. We advanced several potential multi-blockbusters in our pipeline, with FDA approvals and positive Phase III readouts across Rhapsido, Pluvicto, Itvisma and ianalumab. We also strengthened our pipeline through strategic deals, including the proposed acquisition of Avidity, which we expect to close in the first half. In 2026, we expect to grow through the largest patent expiry in Novartis history, underscoring the strength of our business, and remain well on track to deliver our mid-term guidance."

Key figures

Q4 2025 Q4 2024 % change FY 2025 FY 2024 % change

USD m3 USD m3 USD cc USD m3 USD m3 USD cc
Net sales 13 336 13 153 1 -1 54 532 50 317 8 8
Operating income 3 616 3 530 2 4 17 644 14 544 21 25
Net income 2 404 2 820 -15 -14 13 967 11 939 17 19
EPS (USD) 1.26 1.42 -11 -11 7.21 5.92 22 24
Free cash flow 1 655 3 635 -54
17 596 16 253 8
Core operating income 4 929 4 859 1 1 21 889 19 494 12 14
Core net income 3 889 3 933 -1 -2 17 411 15 755 11 12
Core EPS (USD) 2.03 1.98 3 2 8.98 7.81 15 17
1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 44 of the Condensed Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 6. 3. USD millions unless indicated otherwise.

Strategy
Our focus
Novartis is a "pure-play" innovative medicines company. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan.

Our priorities
Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.
Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.

Financials
Fourth quarter
Net sales were USD 13.3 billion (+1%, -1% cc), with volume contributing 18 percentage points to growth. Generic competition had a negative impact of 15 percentage points, including a negative impact of 3 percentage points from revenue deduction adjustments in the US, mainly related to Entresto and Promacta. Pricing had a negative impact of 4 percentage points. Currency had a positive impact of 2 percentage points.

Operating income was USD 3.6 billion (+2%, +4% cc), benefiting from higher government grant income and lower SG&A expenses, partly offset by higher R&D expenses.

Net income was USD 2.4 billion (-15%, -14% cc), impacted by higher income taxes. EPS was USD 1.26 (-11%, -11% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 4.9 billion (+1%, +1% cc), benefiting from higher government grant income and lower SG&A expenses, partly offset by higher R&D expenses. Core operating income margin was 37.0% of net sales, increasing 0.1 percentage points (0.7 percentage points in cc).

Core net income was USD 3.9 billion (-1%, -2% cc), mainly due to lower other financial income. Core EPS was USD 2.03 (+3%, +2% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 1.7 billion (-54%), driven by lower net cash flows from operating activities.

Full year
Net sales were USD 54.5 billion (+8%, +8% cc), with volume contributing 15 percentage points to growth. Generic competition had a negative impact of 6 percentage points, pricing had a negative impact of 1 percentage point and currency had no impact.

Operating income was USD 17.6 billion (+21%, +25% cc), mainly driven by higher net sales and lower impairments, partly offset by higher investments behind priority brands and launches.

Net income was USD 14.0 billion (+17%, +19% cc), mainly driven by higher operating income. EPS was USD 7.21 (+22%, +24% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 21.9 billion (+12%, +14% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Core operating income margin was 40.1% of net sales, increasing 1.4 percentage points (2.1 percentage points cc).

Core net income was USD 17.4 billion (+11%, +12% cc), mainly due to higher core operating income. Core EPS was USD 8.98 (+15%, +17% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 17.6 billion (+8%), driven by higher net cash flows from operating activities.

Q4 priority brands
Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q4 growth) including:

Kisqali (USD 1 321 million, +44% cc) sales grew strongly across all regions, with strong momentum from the early breast cancer indication as well as continued share gains in metastatic breast cancer. Strong volume growth in the US was partially offset by revenue deduction adjustments; underlying growth globally was +54% cc.
Kesimpta (USD 1 228 million, +27% cc) sales grew across all regions driven by increased demand and strong access.
Pluvicto (USD 605 million, +70% cc) sales reflect continued strong demand in the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) setting in the US, as well as access expansion ex-US in the post-taxane mCRPC setting.
Cosentyx (USD 1 807 million, +11% cc) sales grew across all regions, driven by volume, with continued demand for recent launches (including HS and IV in the US) and steady performance in core indications (PsO, PsA, AS and nr-AxSpA).
Scemblix (USD 391 million, +87% cc) sales grew across all regions, demonstrating the continued high unmet need in CML,with strong momentum from the early-line
indication in the US and Japan.
Leqvio (USD 335 million, +46% cc) continued steady growth across all regions, with a focus on increasing account and patient adoption and continuing medical education.
Fabhalta (USD 155 million, +167% cc) sales grew, reflecting continued launch execution in PNH as well as renal indications IgAN and C3G.
ZolgensmaGroup (USD 307 million, +12% cc) sales grew, reflecting strong demand for the IV formulation in the incident SMA population.
Lutathera (USD 203 million, +5% cc) sales grew mainly in the US, Europe and Japan due to increased demand and earlier-line adoption.

Net sales of the top 20 brands in the fourth quarter and full year

Q4 2025 % change FY 2025 % change

USD m USD cc USD m USD cc
Entresto
– excl. revenue deduction adjust.* 1 253

-43
-32 -45
-34 7 748 -1 -2

Cosentyx 1 807 13 11 6 668 9 8
Kisqali
– excl. revenue deduction adjust.* 1 321 46
57 44
54 4 783 58 57

Kesimpta 1 228 29 27 4 426 37 36
Tafinlar + Mekinist 540 2 -2 2 215 8 6
Jakavi 555 14 8 2 110 9 7
Pluvicto 605 72 70 1 994 43 42
Ilaris 514 24 22 1 883 25 24
Xolair 384 -4 -8 1 723 5 4
Promacta/Revolade
– excl. revenue deduction adjust.* 226 -61
-47 -63
-49 1 636 -26 -27

Scemblix 391 89 87 1 285 87 85
ZolgensmaGroup 307 17 12 1 232 1 0
SandostatinGroup 291 -5 -7 1 213 -5 -5
Leqvio 335 50 46 1 198 59 57
Tasigna 179 -56 -58 1 104 -34 -34
Lutathera 203 7 5 816 13 12
ExforgeGroup 181 14 11 727 3 4
Lucentis 133 -37 -40 643 -38 -40
DiovanGroup 157 12 9 604 2 2
Fabhalta 155 172 167 505 291 287
Top 20 brands total 10 765 2 -1 44 513 12 11
*Q4 sales growth impacted by US revenue deduction adjustments in the current and prior year. No significant impact on full year.

R&D update – key developments from the fourth quarter
New approvals
Itvisma
(OAV101 IT) FDA approvedItvismafor the treatment of children two years and older, teens and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene. It is the first and only gene replacement therapy available for this broad population.
Scemblix
(asciminib) EC approved an expanded indication forScemblix, which is now approved for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) in all lines of treatment.
Regulatory updates
Pluvicto
(lutetium Lu177
vipivotide
tetraxetan) FDA submission forPluvictoin PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC) was completed based on Phase III PSMAddition data.
Remibrutinib
(LOU064) FDA submission for remibrutinib in the symptomatic dermographism subtype of chronic inducible urticaria (CIndU) was completed, based on relevant cohort data from the ongoing Phase III REMIND study. Full study readout and submission for the remaining two subtypes of CINDU expected in 2026.
Results from ongoing trials and other highlights
Ianalumab
(VAY736) In the Phase III NEPTUNUS-1 and -2 trials, ianalumab demonstrated a clinically meaningful benefit in Sjögren’s disease, showing both improvement in disease activity and reductions in patient burden. Data presented at ACR. Novartis plans to submit to health authorities globally starting in early 2026. In January, ianalumab was awarded FDA breakthrough designation in Sjögren’s disease.

In the Phase III VAYHIT2 trial, ianalumab plus eltrombopag significantly extended disease control by 45% in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids. The median time to treatment failure (TTF) was 2.8 times longer than placebo plus eltrombopag. Data presented at ASH (Free ASH Whitepaper), simultaneously published in NEJM, and will be included in regulatory submissions in 2027.

Ianalumab is also in Phase III development for first-line ITP, warm autoimmune hemolytic anemia, systemic lupus erythematosus and lupus nephritis.
Pelabresib 96-week results from the Phase III MANIFEST-2 trial with pelabresib plus ruxolitinib continued to show deep and durable spleen volume reduction and sustained improvements in total symptom score and anemia. Data represent the longest follow-up of JAK-inhibitor-naive myelofibrosis patients in a randomized combination trial and showed a comparable safety profile versus ruxolitinib alone, including numerically fewer deaths and disease progressions in pelabresib arm. Data presented at ASH (Free ASH Whitepaper).
KLU156
(ganaplacide/ lumefantrine) In the Phase III KALUMA trial for malaria, KLU156 met its primary endpoint of non-inferiority to the standard of care (SoC), Coartem. The treatment achieved a 97.4% PCR-corrected cure rate using an estimand framework, compared to 94.0% with SoC. Data presented at the American Society of Tropical Medicine and Hygiene annual meeting 2025. If approved, KLU156 would represent the first major innovation in treatment of the deadliest form of malaria in 25 years.
Kisqali
(ribociclib) In a pooled, post-hoc exploratory analysis of first-line patients in the MONALEESA trials, one in four patients with HR+/HER2- advanced breast cancer (aBC) remained progression-free for four or more years following treatment with Kisqali plus endocrine therapy (ET). Data presented at SABCS.

The five-year analysis of the Phase III NATALEE trial in HR+/HER2- early breast cancer (eBC) showed the addition of Kisqali to endocrine therapy reduced the risk of recurrence by 28.4% compared to ET alone. Data also showed a 29.1% risk reduction in distant disease-free survival (DDFS), a positive trend in overall survival and no new safety signals. Data presented at ESMO (Free ESMO Whitepaper). A further sub-analysis was presented at SABCS, showing that Kisqali plus a nonsteroidal aromatase inhibitor (NSAI) continued to result in improved DDFS compared to NSAI alone. The benefit was consistent across subgroups, reinforcing Kisqali plus NSAI as a treatment option for the broadest population of eBC patients.
Pluvicto
(lutetium Lu177
vipivotide
tetraxetan) In the Phase III PSMAddition trial, Pluvicto plus SoC (ARPI + ADT) significantly reduced risk of radiographic progression or death by 28% versus SoC alone, with a positive trend in overall survival at interim analysis (follow-up ongoing), in patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC). Safety profile and tolerability remained consistent with PSMAfore and VISION trials. Data presented at ESMO (Free ESMO Whitepaper).
Cosentyx
(secukinumab) The Phase III REPLENISH study met its primary endpoint, with Cosentyx demonstrating statistically significant and clinically meaningful sustained remission compared to placebo at week 52 in adults with relapsing polymyalgia rheumatica (PMR). Full data will be presented at an upcoming medical congress and submitted to health authorities in H1 2026.
Fabhalta
(iptacopan) In the Phase III APPLAUSE-IgAN final analysis, Fabhalta demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of eGFR decline over two years. Full data will be presented at future medical meetings and included in regulatory submissions in 2026.
Selected transactions Novartis entered into an agreement to acquire Avidity Biosciences, a biopharmaceutical company focused on a new class of therapeutics enabling RNA delivery to muscle. The proposed acquisition will bring Avidity’s late-stage neuroscience programs into Novartis, including potential multi-billion-dollar opportunities for DM1 and FSHD, and provide access to a differentiated RNA-targeting delivery platform. Transaction expected to close in H1 2026, subject to completion of the separation of SpinCo from Avidity and other customary closing conditions.
Capital structure and net debt
Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority.

In 2025, Novartis repurchased a total of 77.6 million shares for USD 8.9 billion on the SIX Swiss Exchange second trading line. These repurchases included 49.1 million shares (USD 5.4 billion) under the USD 15 billion share buyback (announced in July 2023 and completed in July 2025) and 17.8 million shares (USD 2.3 billion) under the new up-to USD 10 billion share buyback announced in July 2025. In addition, 10.7 million shares (USD 1.3 billion) were repurchased to mitigate the full-year dilution related to equity-based compensation plans of employees. Furthermore, 1.7 million shares (equity value of USD 0.2 billion) were repurchased from employees. In the same period, 12.4 million shares (equity value of USD 1.2 billion) were delivered to employees related to equity-based compensation plans. Consequently, the total number of shares outstanding decreased by 66.9 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 8.0 billion and a net cash outflow of USD 9.2 billion.

Net debt increased to USD 21.9 billion at December 31, 2025, compared to USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 17.6 billion being more than offset by the cash outflows for treasury share transactions of USD 9.2 billion, the USD 7.8 billion annual dividend payment, and net cash outflow for M&A, intangible assets transactions and other acquisitions of USD 5.2 billion.

On December 31, 2025, Novartis reached the 2025 Patient Access Targets under its sustainability-linked bond issued in 2020 and therefore, no interest rate adjustment will be applied, and the bond will continue to pay 0.000% interest until its Maturity Date on September 23, 2028.

As of Q4 2025, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings.

2026 outlook

Barring unforeseen events; growth vs. prior year in cc
Net sales Expected to grow low single-digit
Core operating income Expected to decline low single-digit
Foreign exchange impact
If late-January exchange rates prevail for the remainder of 2026, the foreign exchange impact for the year would be positive 2 to positive 3 percentage points on net sales and positive 1 percentage point on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Agreement with US government on lowering drug prices in the US
On December 19, 2025, Novartis reached an agreement with the US government that aims to lower the price of innovative medicines in the US and support continued US investment in manufacturing, and research and development. The implications of that agreement are reflected in our 2026 guidance and in our 5-6% five-year sales CAGR guidance for 2025-2030. We will continue to monitor the longer-term implications as the agreement is implemented.

Annual General Meeting
Dividend proposal
The Novartis Board of Directors proposes a dividend payment of CHF 3.70 per share for 2025, up 5.7% from CHF 3.50 per share in the prior year, representing the 29th consecutive dividend increase since the creation of Novartis in December 1996. Shareholders will vote on this proposal at the Annual General Meeting on March 6, 2026.

Reduction of share capital
The Novartis Board of Directors proposes to cancel 77 602 358 shares (36 725 440 shares repurchased under the authorization of March 7, 2023, and 40 876 918 shares repurchased under the authorization of March 7, 2025) and to reduce the share capital accordingly by CHF 38 025 155.42, from CHF 1 035 086 714.83 to CHF 997 061 559.41.

Elections of the Board Chair and members of the Board of Directors
Mr. Daniel Hochstrasser will not stand for re-election to the Board of Directors. The Board and Executive Committee of Novartis thank him for his years of dedicated service as a member of the Board.

The Board of Directors proposes the re-election of all other current members of the Board, including the Board Chair.

In addition, the Board proposes the election of Dr. Charles Swanton, a distinguished physician-scientist in oncology, to the Board of Directors.

Key figures1

Q4 2025 Q4 2024 % change FY 2025 FY 2024 % change

USD m2 USD m2 USD cc
USD m2 USD m2 USD cc
Net sales 13 336 13 153 1 -1
54 532 50 317 8 8
Operating income 3 616 3 530 2 4
17 644 14 544 21 25
As a % of sales 27.1 26.8

32.4 28.9

Net income 2 404 2 820 -15 -14
13 967 11 939 17 19
EPS (USD) 1.26 1.42 -11 -11
7.21 5.92 22 24
Net cash flows from
operating activities 2 264 4 193 -46

19 144 17 619 9

Non-IFRS measures

Free cash flow 1 655 3 635 -54

17 596 16 253 8
Core operating income 4 929 4 859 1 1
21 889 19 494 12 14
As a % of sales 37.0 36.9

40.1 38.7

Core net income 3 889 3 933 -1 -2
17 411 15 755 11 12
Core EPS (USD) 2.03 1.98 3 2
8.98 7.81 15 17
1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 44 of the Condensed Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. USD millions unless indicated otherwise.

(Press release, Novartis, FEB 4, 2026, View Source [SID1234662472])

Immunome to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026

On February 4, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that Immunome management will present at Guggenheim’s Emerging Outlook: Biotech Summit on February 11, 2026, at 9 a.m. ET.

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Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

(Press release, Immunome, FEB 4, 2026, View Source [SID1234662488])

IN8bio to Present at Upcoming Investor and Scientific Conferences in February

On February 3, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ ) T cell therapies for cancer and autoimmune diseases, reported that William Ho, CEO and co-founder, will be presenting the following investor and scientific conferences in February.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference participation details are as follows:

Noble Emerging Growth Virtual Equity Conference
Date: Thursday, February 5, 2026
Time: 3:00 p.m. ET
Location: Virtual
Investor Registration

IO360° Conference
Date: Thursday, February 12, 2026
Time: 1:20 p.m. – 1:40 p.m. ET
Session: IO Clinical Advancements Plenary
Presentation title: IN8bio’s Unique DeltEx Drug Resistant Immunotherapy (DRI) Approach to Solid Tumors & Results from Phase 1/2 Study in Newly Diagnosed GBM

Additional details, including any available webcast information, will be posted on the Events & Presentations section of the Company’s website at www.in8bio.com.

(Press release, In8bio, FEB 3, 2026, View Source [SID1234662427])

CareDx to Present AlloHeme™ Pivotal Clinical Validation Data in Hematologic Cancer Relapse Detection at 2026 Tandem Meetings

On February 3, 2026 CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high‑value healthcare solutions for transplant patients and caregivers, reported that pivotal clinical validation data from the ACROBAT study (NCT04635384) will be presented at the 2026 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, held February 4-7, 2026, in Salt Lake City, Utah.

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The ACROBAT study is a prospective, multi-center, blinded clinical trial evaluating AlloHeme, CareDx’s AI-powered next-generation sequencing (NGS)-based peripheral blood test for monitoring relapse after allogeneic hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. AlloHeme identifies cancer relapse ahead of traditional detection methods, potentially enabling timely clinical interventions. The ACROBAT study includes patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) monitored with AlloHeme for cancer relapse at 11 hematopoietic stem cell transplant centers across the U.S.

The oral presentation will feature the complete 24-month follow-up results, building upon 18-month interim results published in the conference abstract, available online here.

In addition, on February 12, 2025, CareDx will host an investor webcast and conference call to discuss the study findings and commercial launch timeline.

Tandem Presentation Details:

Presentation ID 61: Acrobat Interim Results: Peripheral Blood-Based AlloHeme Test Enables Robust Relapse Surveillance in Post-HCT AML and MDS Patients
Presenter: Dr. Ran Reshef, Professor of Medicine at Columbia University and Director of Translational Research, Blood and Marrow Transplantation Program at Herbert Irving Comprehensive Cancer Center
Date & Time: Friday, February 6, 3:15 p.m. MT
Location: Ballroom I, Salt Palace Convention Center
Investor Webcast Details:

Presentation: AlloHeme Clinical Validation Data Review and Launch Timeline
Date & Time: Thursday, February 12, 7 a.m. PT / 10 a.m. ET
The one-hour event will feature presentations by members of the CareDx’s leadership team and ACROBAT study site Principal Investigator, Dr. Ran Reshef.
A live and archived webcast can be accessed on the Events & Presentations section of CareDx’s Investor Relations website at investors.caredx.com. To participate in the live conference call via telephone, register here. Upon registering, a dial-in number and unique PIN will be provided.

(Press release, CareDx, FEB 3, 2026, View Source [SID1234662443])

Merck & Co., Inc., Rahway, N.J., USA Announces Fourth-Quarter and Full-Year 2025 Financial Results; Highlights Progress Advancing Broad, Diverse Pipeline

On February 3, 2026 Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, reported financial results for the fourth quarter and full year of 2025.

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"In 2025, we continued to advance leading-edge science to deliver transformative medicines and vaccines that are improving health outcomes for patients around the world," said Robert M. Davis, chairman and chief executive officer. "Our business benefited from demand for our innovative portfolio, including for KEYTRUDA, increasing contributions from new launches in cardiometabolic and respiratory as well as vaccines, and strong performance of Animal Health. The transformation of our portfolio, bolstered by the acquisitions of Verona Pharma and Cidara Therapeutics, is well underway, and momentum is building as we continue to execute on our strategy. Our progress positions us to continue delivering on our purpose for patients and creating durable value for shareholders."

Financial Summary

$ in millions, except EPS amounts

Fourth Quarter

Year Ended

2025

2024

Change

Change Ex-Exchange

Dec. 31, 2025

Dec. 31, 2024

Change

Change Ex-Exchange

Sales

$16,400

$15,624

5%

4%

$65,011

$64,168

1%

2%

GAAP net income1

2,963

3,743

-21%

-20%

18,254

17,117

7%

9%

Non-GAAP net income that excludes certain items1,2*

5,088

4,372

16%

17%

22,513

19,444

16%

18%

GAAP EPS

1.19

1.48

-20%

-18%

7.28

6.74

8%

10%

Non-GAAP EPS that excludes certain items2*

2.04

1.72

19%

19%

8.98

7.65

17%

19%

*Refer to table on page 9.

Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.19 for the fourth quarter and $7.28 for the full year of 2025. Non-GAAP EPS was $2.04 for the fourth quarter and $8.98 for the full year of 2025. GAAP and non-GAAP EPS in the fourth quarter of 2025 include a charge of $0.05 per share related to an agreement with Dr. Falk Pharma GmbH (Falk) pursuant to which the Company secured the sole global rights to MK-8690. GAAP and non-GAAP EPS in the fourth quarter of 2024 include a charge of $0.23 per share related to the execution of licensing agreements with LaNova Medicines Ltd. (acquired by Sino Pharmaceutical Limited) and Hansoh Pharma. GAAP and non-GAAP EPS for the full years of 2025 and 2024 include charges of $0.20 and $1.28 per share, respectively, related to certain licensing agreements and asset acquisitions.

Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in 2025 also excludes a net tax benefit, which reflects a net benefit related to favorable audit reserve adjustments. Non-GAAP EPS in the fourth quarter and full year of 2024 also exclude a benefit due to a reduction in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years.

Fourth-Quarter Sales Performance

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

Fourth Quarter

$ in millions

2025

2024

Change

Change Ex-Exchange

Commentary

Total Sales

$16,400

$15,624

5%

4%

Pharmaceutical

14,843

14,042

6%

4%

Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by a decline in vaccines.

KEYTRUDA/ KEYTRUDA QLEX

8,372

7,836

7%

5%

Growth driven by strong global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), renal cell carcinoma, cervical and head and neck cancers, as well as continued global demand in metastatic indications, including urothelial, gastric and endometrial cancers. Sales growth was partially offset by timing of purchases in the U.S. Sales of KEYTRUDA QLEX were $35 million.

GARDASIL/
GARDASIL 9

1,031

1,550

-34%

-35%

Decline primarily due to lower demand in China, as well as lower sales in Japan following the national catch-up immunization program, partially offset by higher sales in the U.S. and timing in certain international markets.

PROQUAD, M-M-R II and VARIVAX

619

594

4%

3%

Increase primarily reflects higher sales of PROQUAD, which largely resulted from both the replenishment of doses borrowed from the U.S. Centers for Disease Control and Prevention Pediatric Vaccine Stockpile and from higher demand in Europe, partially offset by lower demand for M-M-R II in certain international markets and lower demand for VARIVAX in the U.S.

JANUVIA/JANUMET

501

487

3%

3%

Growth driven by higher net pricing in the U.S., partially offset by lower demand in China as well as in most other international markets due to generic competition.

BRIDION

499

449

11%

11%

Growth primarily due to higher demand and net pricing in the U.S., partially offset by lower demand in several international markets due to ongoing generic competition.

WINREVAIR

467

200

133%

133%

Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, partially offset by lower net pricing in the U.S. largely due to Medicare Part D redesign.

Lynparza*

389

365

7%

4%

Growth primarily due to higher demand in several international markets.

CAPVAXIVE

279

50

N/M

N/M

Growth largely due to continued uptake in the U.S.

PREVYMIS

275

215

28%

26%

Increase primarily due to higher demand in the U.S. as well as in most international markets, reflecting in part the launch of new indications.

Lenvima*

272

255

7%

6%

Increase due to higher sales in the U.S., primarily reflecting higher demand, partially offset by lower pricing.

WELIREG

220

160

37%

37%

Growth primarily due to higher demand in the U.S. and continued launch uptake in several international markets, partially offset by lower net pricing in the U.S.

OHTUVAYRE

178

Represents sales following the Company’s Oct. 7, 2025 acquisition of Verona Pharma plc (Verona Pharma).

Animal Health

1,505

1,397

8%

6%

Growth primarily due to higher demand of livestock products.

Livestock

987

889

11%

9%

Growth primarily driven by higher demand across all species, as well as improved supply and new product launches.

Companion Animal

518

508

2%

0%

Growth from new product launches was partially offset by lower demand for other products in portfolio, reflecting a reduction in veterinary visits. Sales of BRAVECTO line of products were $222 million and $209 million in current and prior-year quarters, respectively, which represents an increase of 6%, or 5% excluding impact of foreign exchange.

Other Revenues**

52

185

-71%

-15%

Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements.

*Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

N/M – Not meaningful.

Full-Year Sales Performance

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

Year Ended

$ in millions

Dec. 31, 2025

Dec. 31, 2024

Change

Change Ex-Exchange

Total Sales

$65,011

$64,168

1%

2%

Pharmaceutical

58,142

57,400

1%

1%

KEYTRUDA/KEYTRUDA QLEX

31,680

29,482

7%

7%

GARDASIL/GARDASIL 9

5,233

8,583

-39%

-39%

JANUVIA/JANUMET

2,544

2,268

12%

13%

PROQUAD, M-M-R II and VARIVAX

2,451

2,485

-1%

-2%

BRIDION

1,841

1,764

4%

4%

Lynparza*

1,450

1,311

11%

10%

WINREVAIR

1,443

419

N/M

N/M

Lenvima*

1,053

1,010

4%

4%

PREVYMIS

978

785

25%

23%

VAXNEUVANCE

825

808

2%

1%

CAPVAXIVE

759

97

N/M

N/M

WELIREG

716

509

41%

41%

ROTATEQ

673

711

-5%

-5%

Reblozyl*

525

371

41%

41%

LAGEVRIO

380

964

-61%

-61%

Simponi**

543

-100%

-100%

Animal Health

6,354

5,877

8%

9%

Livestock

3,896

3,462

13%

14%

Companion Animal

2,458

2,415

2%

2%

Other Revenues***

515

891

-42%

-6%

*Alliance revenue for Lynparza and Lenvima represent the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. Alliance revenue for Reblozyl represents royalties.

**Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024.

***Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

N/M – Not meaningful.

In addition, Koselugo alliance revenue was $436 million for the full year of 2025 compared with $170 million for the full year of 2024. The increase was due to an amendment to the collaboration agreement with AstraZeneca in 2025, which discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure, resulting in the Company’s recognition of a $150 million upfront payment and $175 million of regulatory milestones.

Full-year 2025 Pharmaceutical sales were $58.1 billion, representing growth of 1% both nominally and excluding the impact of foreign exchange. Sales growth was primarily driven by higher sales in oncology, particularly KEYTRUDA and WELIREG, as well as increased alliance revenue from Koselugo (resulting from the amendment to the collaboration agreement noted above), Reblozyl and Lynparza. Also contributing to sales growth were higher sales in the cardiometabolic and respiratory franchise largely attributable to the ongoing launch of WINREVAIR, as well as the inclusion of OHTUVAYRE sales resulting from the acquisition of Verona Pharma, which closed on Oct. 7, 2025. Growth in the diabetes franchise, largely attributable to higher net pricing of JANUVIA in the U.S., also contributed to sales growth. Sales growth in 2025 was partially offset by lower sales in the vaccines franchise reflecting lower sales of GARDASIL/GARDASIL 9, which were offset in part by the ongoing launch of CAPVAXIVE and the U.S. launch of ENFLONSIA. Lower sales in the immunology franchise (due to the return of the marketing rights for Simponi and Remicade in former Company territories to Johnson & Johnson on Oct. 1, 2024) and lower sales in the virology franchise (largely attributable to LAGEVRIO) also offset Pharmaceutical sales growth in 2025.

Full-year 2025 Animal Health sales were $6.4 billion, representing growth of 8%, or 9% excluding the impact of foreign exchange. Sales growth was primarily driven by the performance of Livestock products across all species and new product launches in Companion Animal. Sales of the BRAVECTO line of products were $1.1 billion in 2025, representing growth of 1% both nominally and excluding the impact of foreign exchange.

Fourth-Quarter and Full-Year Expense and Related Information

The table below presents selected expense information.

$ in millions

GAAP

Acquisition-
and
Divestiture-
Related Costs3

Restructuring
Costs

(Income)
Loss From
Investments
in Equity
Securities

Non-
GAAP2

Fourth Quarter 2025

Cost of sales

$5,551

$1,054

$1,173

$-

$3,324

Selling, general and administrative

2,898

48

2

2,848

Research and development

3,886

5

(111)

3,992

Restructuring costs

213

213

Other (income) expense, net

432

206

226

Fourth Quarter 2024

Cost of sales

$3,828

$701

$121

$-

$3,006

Selling, general and administrative

2,864

29

16

2,819

Research and development

4,585

12

(1)

4,574

Restructuring costs

51

51

Other (income) expense, net

126

(31)

152

5

$ in millions

GAAP

Acquisition-
and
Divestiture-
Related Costs3

Restructuring
Costs

(Income)
Loss From
Investments
in Equity
Securities

Non-
GAAP2

Year Ended Dec. 31, 2025

Cost of sales

$16,382

$2,871

$1,484

$-

$12,027

Selling, general and administrative

10,733

120

3

10,610

Research and development

15,789

19

175

15,595

Restructuring costs

889

889

Other (income) expense, net

151

(3)

(306)

460

Year Ended Dec. 31, 2024

Cost of sales

$15,193

$2,409

$495

$-

$12,289

Selling, general and administrative

10,816

117

83

10,616

Research and development

17,938

72

1

17,865

Restructuring costs

309

309

Other (income) expense, net

(24)

(79)

45

10

GAAP Expense, EPS and Related Information

Gross margin was 66.2% for the fourth quarter of 2025 compared with 75.5% for the fourth quarter of 2024. Gross margin was 74.8% for the full year of 2025 compared with 76.3% for the full year of 2024. The gross margin decline in both periods was primarily due to the unfavorable impacts of higher restructuring costs (primarily related to the accelerated depreciation of manufacturing lines at two sites under the 2025 Restructuring Program), inventory write-offs and amortization of intangible assets, as well as the recognition of inventory fair value step-up related to the Verona Pharma acquisition, partially offset by the favorable impact of product mix.

Selling, general and administrative (SG&A) expenses were $2.9 billion in the fourth quarter of 2025, an increase of 1% compared with the fourth quarter of 2024. The increase was primarily due to higher administrative costs, partially offset by lower promotional costs. Full-year 2025 SG&A expenses were $10.7 billion, a decrease of 1% compared with the full year of 2024. The decrease was primarily due to lower restructuring and promotional costs, partially offset by increased administrative costs.

Research and development (R&D) expenses were $3.9 billion in the fourth quarter of 2025, a decrease of 15% compared with the fourth quarter of 2024. The decrease was primarily due to lower charges for business development activity and a reduction to estimated contractual termination costs associated with restructuring actions, partially offset by higher clinical development costs. R&D expenses were $15.8 billion for the full year of 2025, a decrease of 12% compared with the full year of 2024. The decrease was primarily due to lower charges for business development activity, partially offset by higher clinical development spending and higher restructuring costs.

Other (income) expense, net, was $432 million of expense in the fourth quarter of 2025 compared with $126 million of expense in the fourth quarter of 2024 primarily due to higher net interest expense, higher foreign exchange losses and increased net losses from investments in equity securities. Other (income) expense, net, was $151 million of expense in the full year of 2025 compared with $24 million of income in the full year of 2024. The unfavorable year-over-year change primarily reflects $170 million of income in 2024 related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as higher net interest expense and higher foreign exchange losses in 2025, partially offset by higher net income from investments in equity securities in 2025.

The effective tax rate was 13.4% for the fourth quarter of 2025 and 13.3% for the full year of 2025.

GAAP EPS was $1.19 for the fourth quarter of 2025 compared with $1.48 for the fourth quarter of 2024. The decrease was primarily driven by higher restructuring costs and amortization of intangible assets, partially offset by favorability from lower charges for business development transactions, as well as operational strength in the business driven in part by the benefits of the previously announced multiyear optimization initiative. GAAP EPS was $7.28 for the full year of 2025 compared with $6.74 for the full year of 2024. The increase was primarily driven by favorability from lower charges for business development transactions and operational strength in the business, partially offset by higher restructuring costs and amortization of intangible assets.

Non-GAAP Expense, EPS and Related Information

Non-GAAP gross margin was 79.7% for the fourth quarter of 2025 compared with 80.8% for the fourth quarter of 2024. The decrease was primarily due to higher inventory write-offs, partially offset by the favorable impact of product mix. Non-GAAP gross margin was 81.5% for the full year of 2025 compared with 80.8% for the full year 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 $2.8 billion in the fourth quarter of 2025, an increase of 1% compared with the fourth quarter of 2024. The increase was primarily due to higher administrative costs, partially offset by lower promotional costs. Non-GAAP SG&A expenses were $10.6 billion for the full year of 2025, flat compared with the full year of 2024 as lower promotional costs were largely offset by higher administrative costs.

Non-GAAP R&D expenses were $4.0 billion in the fourth quarter of 2025, a decrease of 13% compared with the fourth quarter of 2024. Non-GAAP R&D expenses were $15.6 billion for the full year of 2025, a decrease of 13% compared with the full year of 2024. The decrease in both periods was primarily due to lower charges for business development activity, partially offset by higher clinical development costs.

Non-GAAP other (income) expense, net, was $226 million of expense in the fourth quarter of 2025 compared with $5 million of expense in the fourth quarter of 2024 primarily due to higher net interest expense and higher foreign exchange losses. Non-GAAP other (income) expense, net, was $460 million of expense in the full year of 2025 compared with $10 million of expense in the full year of 2024. The unfavorable year-over-year change primarily reflects $170 million of income in 2024 related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as higher net interest expense and higher foreign exchange losses in 2025.

The non-GAAP effective tax rate was 15.4% for the fourth quarter of 2025 and 14.4% for the full year of 2025.

Non-GAAP EPS was $2.04 for the fourth quarter of 2025 compared with $1.72 for the fourth quarter of 2024. Non-GAAP EPS was $8.98 for the full year of 2025 compared with $7.65 for the full year of 2024. The increase in both periods was primarily driven by favorability from lower charges for business development transactions, as well as operational strength in the business driven in part by the benefits of the previously announced multiyear optimization initiative.

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

Fourth Quarter

Year Ended

$ in millions, except EPS amounts

2025

2024

Dec. 31, 2025

Dec. 31, 2024

EPS

GAAP EPS

$1.19

$1.48

$7.28

$6.74

Difference

0.85

0.24

1.70

0.91

Non-GAAP EPS that excludes items listed below2

$2.04

$1.72

$8.98

$7.65

Net Income

GAAP net income1

$2,963

$3,743

$18,254

$17,117

Difference

2,125

629

4,259

2,327

Non-GAAP net income that excludes items listed below1,2

$5,088

$4,372

$22,513

$19,444

Excluded Items:

Acquisition- and divestiture-related costs3

$1,107

$711

$3,007

$2,519

Restructuring costs

1,277

187

2,551

888

Loss (income) from investments in equity securities

206

152

(306)

45

Decrease to net income before taxes

2,590

1,050

5,252

3,452

Estimated income tax (benefit) expense4

(465)

(421)

(993)

(1,125)

Decrease to net income

$2,125

$629

$4,259

$2,327

Pipeline and Portfolio Highlights

In 2025, the Company announced positive late-stage trial results from 18 Phase 3 trials and began enrolling patients in 21 new Phase 3 studies evaluating multiple indications and therapeutic areas, with approximately 80 Phase 3 studies currently underway.

Throughout the fourth quarter, the Company made important progress to advance its broad, diverse pipeline, meeting significant regulatory and clinical milestones.

Oncology:
U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, for the perioperative treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy based on Phase 3 KEYNOTE-905 trial.
Approvals represent the first PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens for this patient population.
FDA awarded a priority review voucher under the Commissioner’s National Priority Voucher (CNPV) pilot program for sac-TMT, an investigational anti-TROP2 ADC being developed in collaboration with Kelun-Biotech.
European Commission (EC) approved the subcutaneous route of administration and new pharmaceutical formulation of KEYTRUDA for use across all KEYTRUDA indications for adult patients in Europe.
FDA accepted two supplemental Biologics License Applications (sBLAs) for KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of certain patients with PD-L1+ inoperable (unresectable) locally advanced or metastatic TNBC based on Phase 3 KEYNOTE-D19/ASCENT-04 trial.
FDA set Prescription Drug User Fee Act (PDUFA) dates in the second half of 2026 for these applications.
Announced positive topline results from Phase 3 KEYNOTE-B15 trial in patients with MIBC who are eligible for cisplatin-based chemotherapy showing KEYTRUDA plus Padcev significantly improved event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates versus neoadjuvant chemotherapy and surgery when given before and after surgery.
In collaboration with Moderna, Inc. (Moderna), announced median five-year follow-up data from Phase 2b KEYNOTE-942/mRNA-4157-P201 study for intismeran autogene, an investigational mRNA-based individualized neoantigen therapy, in combination with KEYTRUDA in patients with high-risk melanoma (stage III/IV) following complete resection.

Infectious Diseases:
Announced positive topline results from the Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of adults with HIV-1 infection who had not previously received antiretroviral treatment (treatment-naïve).

Cardiometabolic and Respiratory:
Presented new data at the American Heart Association Scientific Sessions 2025, including results from the Phase 3 CORALreef Lipids and heterozygous familial hypercholesterolemia (HeFH) trials, demonstrating that enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hypercholesterolemia, significantly reduced low-density lipoprotein cholesterol (LDL-C) with a safety profile comparable to placebo.
FDA awarded a priority review voucher under the CNPV pilot program for enlicitide decanoate.
In January 2026, EC approved an expanded indication for WINREVAIR, in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH (Group 1 pulmonary hypertension) in adult patients with World Health Organization (WHO) Functional Class II, III and IV based on Phase 3 ZENITH trial.
In February 2026, FDA accepted a new sBLA for WINREVAIR seeking approval to update the U.S. product label based on Phase 3 HYPERION trial.
FDA set PDUFA date of September 21, 2026.
Announced that Phase 2, proof-of-concept CADENCE study evaluating WINREVAIR in adults for the treatment of combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF) met its primary endpoint.

Business Development:
In 2026, completed acquisition of Cidara Therapeutics, Inc. (Cidara) for a total transaction value of approximately $9.2 billion.
Added MK-1406 (formerly CD388), an investigational long-acting, strain-agnostic antiviral agent designed to prevent influenza infection in individuals at higher risk of complications, to the Company’s portfolio.
MK-1406 is currently being evaluated in the Phase 3 ANCHOR study.
Entered into strategic financing agreement with Blackstone Life Sciences to partially fund the development of sac-TMT in 2026.
Entered into an agreement with Falk for certain development and commercialization rights to MK-8690, an investigational anti-CD30 ligand monoclonal antibody.
Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.*

Oncology

FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Perioperative Treatment for Adults With Cisplatin-Ineligible MIBC; Based on Results From Phase 3 KEYNOTE-905 Trial

EC Approved Subcutaneous Administration of KEYTRUDA for All Adult Indications Approved in EU; Based on Results From Phase 3 3475A-D77 Trial

KEYTRUDA Plus Padcev Significantly Improved EFS, OS and pCR Rates for Cisplatin-Eligible Patients With MIBC When Given Before and After Surgery; Based on Results From Phase 3 KEYNOTE-B15 Trial

The Company and Moderna Announced 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA Demonstrated Sustained Improvement in the Primary Endpoint of Recurrence-Free Survival in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection; Based on Follow-up Analysis From Phase 2b KEYNOTE-942/mRNA-4157-P201 Trial

The Company Initiated Phase 3 KANDLELIT-007 Trial Evaluating Calderasib (MK-1084),

an Investigational Oral KRAS G12C Inhibitor, in Combination With KEYTRUDA QLEX in Certain Patients With Advanced NSCLC

The Company Presented Data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2025 That Showcased Continued Advancements in Hematology Pipeline and Novel Therapeutic Approaches

Vaccines and Infectious Diseases

The Company Announced Positive Topline Results From Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of DOR/ISL in Treatment-Naïve Adults With HIV-1 Infection

Cardiometabolic and Respiratory

Enlicitide Decanoate Significantly Reduced LDL-C in Phase 3 CORALreef Lipids Trial

Enlicitide Decanoate Significantly Reduced LDL-C in Adults With HeFH in Phase 3 CORALreef HeFH Trial

WINREVAIR Met Primary Endpoint in Phase 2, Proof-Of-Concept CADENCE Study in Adults With CpcPH Due to HFpEF

Neuroscience

The Company Showcased Data for Alzheimer’s Disease Candidates MK-2214 and MK-1167 at Clinical Trials on Alzheimer’s Disease 2025

Animal Health

FDA Conditionally Approved EXZOLT CATTLE-CA1 for Prevention and Treatment of New World Screwworm (Cochliomyia Hominivorax) Larvae (Myiasis)

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

U.S. Government Agreement

The Company reached an agreement with the U.S. government that is intended to lower medicine costs for Americans. This agreement enables the Company to continue its long-standing commitment to advancing breakthrough scientific discoveries for patients and helps ensure Americans can access the medicines they need at lower costs. The voluntary agreement addresses all four components of the President’s July letter.

Under the agreement, among other things, the Company plans to provide key products through a direct-to-patient program at affordable prices for eligible patients in the U.S. In addition, the Company reached an understanding with the U.S. Department of Commerce to delay Section 232 tariffs for three years, enabling the Company to make investments in the U.S. to reshore manufacturing for American patients. The Company has committed more than $70 billion in capital and R&D spending to strengthen U.S. production and innovation.

Full-Year 2026 Financial Outlook

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

Full Year 2026

Sales*

$65.5 billion to $67.0 billion

Non-GAAP Gross margin2

Approximately 82%

Non-GAAP Operating expenses2**

$35.9 billion to $36.9 billion

Non-GAAP Other (income) expense, net2

Approximately $1.3 billion expense

Non-GAAP Effective tax rate2

23.5% to 24.5%

Non-GAAP EPS2***

$5.00 to $5.15

Share count (assuming dilution)

Approximately 2.48 billion

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

**Includes a one-time charge of approximately $9.0 billion associated with the acquisition of Cidara. Outlook does not assume any additional significant potential business development transactions.

***Includes a one-time charge of approximately $3.65 per share associated with the acquisition of Cidara.

The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results.

The Company anticipates full-year 2026 sales to be between $65.5 billion and $67.0 billion, including a positive impact from foreign exchange of approximately 1% at mid-January 2026 exchange rates.

The Company’s full-year non-GAAP effective income tax rate is expected to be between 23.5% and 24.5% including the impact of the non-tax deductible one-time charge for the acquisition of Cidara.

The Company expects full-year 2026 non-GAAP EPS to be between $5.00 and $5.15, including a positive impact from foreign exchange of approximately $0.10 per share at mid-January 2026 exchange rates. This range includes a one-time charge of approximately $9.0 billion, or approximately $3.65 per share, as well as approximately $0.30 per share of related financing and operational costs, related to the acquisition of Cidara. In 2025, non-GAAP EPS of $8.98 was negatively impacted by one-time charges of $0.20 per share related to certain business development transactions.

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

Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, as well as income and losses from investments in equity securities.

Earnings Conference Call

Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, Feb. 3, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.

(Press release, Merck & Co, FEB 3, 2026, View Source [SID1234662428])