On April 30, 2026 Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, reported financial results for the first quarter of 2026.

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"We are moving with speed to transform our portfolio to one with a diversified set of growth drivers across a broad set of therapeutic areas," said Robert M. Davis, chairman and chief executive officer. "During the first quarter, we continued to strengthen our pipeline with science-led business development, including our planned acquisition of Terns. We also achieved several important milestones, such as the FDA approval of IDVYNSO – which marks a new chapter in our longstanding commitment to people living with HIV. I am pleased with our progress and excited for what’s ahead, as we enter a particularly robust period of Phase 3 data readouts and deliver on the promise of our pipeline for patients."

Financial Summary

$ in millions, except EPS amounts

First Quarter

2026

2025

Change

Change
Ex-
Exchange

Sales

$16,286

$15,529

5%

3%

GAAP net (loss) income2

(4,240)

5,079

N/M

N/M

Non-GAAP net (loss) income that excludes certain items2,3*

(3,156)

5,611

N/M

N/M

GAAP EPS

(1.72)

2.01

N/M

N/M

Non-GAAP EPS that excludes certain items3*

(1.28)

2.22

N/M

N/M

*Refer to table on page 7.

N/M – Not meaningful.

For the first quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $1.72 and non-GAAP loss per share was $1.28. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Cidara Therapeutics, Inc. (Cidara) of $3.62 per share.

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.

First-Quarter Sales Performance
The following table reflects sales of the Company’s top products and significant performance drivers.

First Quarter

$ in millions

2026

2025

Change

Change
Ex-
Exchange

Commentary

Total Sales

$16,286

$15,529

5%

3%

Pharmaceutical

14,349

13,638

5%

2%

Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by declines in vaccines, diabetes and infectious diseases.

KEYTRUDA/ KEYTRUDA QLEX

8,034

7,205

12%

8%

Growth primarily driven by higher global demand in metastatic indications including urothelial cancer, as well as strong global uptake in earlier-stage indications, including triple-negative breast cancer, cervical cancer and renal cell carcinoma (RCC). Sales growth benefited from the timing of wholesaler purchases in the U.S. Sales of KEYTRUDA QLEX were $128 million.

GARDASIL/
GARDASIL 9

1,069

1,327

-19%

-22%

Decline primarily due to lower demand in China as well as lower sales in Japan following the national catch-up immunization program. Decline also reflects lower sales in the U.S. primarily due to unfavorable public-sector purchasing patterns, partially offset by higher net pricing.

JANUVIA/JANUMET

574

796

-28%

-29%

Decline primarily due to lower demand and net pricing in the U.S., as well as lower demand in China and most other international markets due to generic competition.

PROQUAD, M-M-R II and VARIVAX

538

539

0%

-2%

Sales were flat, primarily driven by unfavorable private sector purchasing patterns for M-M-R II and lower demand for M-M-R II and VARIVAX in the U.S., offset by higher PROQUAD sales in the U.S. due to borrowing of doses in 2025 from a U.S. government stockpile, which lowered sales in that period.

WINREVAIR

525

280

88%

87%

Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe.

BRIDION

472

441

7%

7%

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

Lynparza*

341

312

9%

6%

Growth primarily due to higher demand in the U.S. and many international markets.

PREVYMIS

272

208

31%

26%

Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications.

Lenvima*

256

258

-1%

-2%

Relatively flat compared with prior year.

ROTATEQ

206

228

-10%

-11%

Decrease primarily driven by lower demand in China.

VAXNEUVANCE

202

230

-12%

-16%

Decrease primarily driven by lower demand in the U.S. and most international markets due to competitive pressure.

WELIREG

199

137

45%

43%

Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan and certain European markets.

CAPVAXIVE

142

107

33%

31%

Increase primarily driven by launch uptake in certain European markets and continued uptake in the U.S. U.S. sales growth was partially offset by a reduction in wholesaler inventory.

OHTUVAYRE

131

–

–

–

Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc (Verona Pharma).

LAGEVRIO

28

102

-73%

-73%

Decline largely due to lower demand in Japan and the U.S.

Animal Health

1,791

1,588

13%

6%

Growth attributable to performance in both Livestock and Companion Animal product portfolios.

Livestock

1,064

924

15%

8%

Growth primarily driven by higher demand for ruminant and poultry products as well as price.

Companion Animal

727

664

9%

4%

Growth from new product launches and price was partially offset by lower demand for other products in portfolio, reflecting a reduction in veterinary visits. Sales of BRAVECTO line of products were $379 million and $327 million in current and prior-year quarters, respectively, which represents an increase of 16%, or 9% excluding impact of foreign exchange.

Other Revenues**

146

303

-52%

4%

Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements, partially offset by higher milestones received for out-licensing arrangements and higher royalty income.

*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.

In addition, Koselugo alliance revenue was $161 million for the first quarter of 2026 compared with $44 million for the first quarter of 2025. The increase was due to a $150 million payment received in the first quarter of 2026 in connection with an amendment to the collaboration agreement with AstraZeneca in 2025, which (subject to an annual election by AstraZeneca) discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure.

First-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

First Quarter 2026

Cost of sales

$4,195

$1,014

$237

$ –

$2,944

Selling, general and administrative

2,700

32

–

–

2,668

Research and development

12,592

–

34

–

12,558

Restructuring costs

195

–

195

–

–

Other (income) expense, net

138

–

–

(180)

318

First Quarter 2025

Cost of sales

$3,419

$620

$36

$-

$2,763

Selling, general and administrative

2,552

23

–

–

2,529

Research and development

3,621

7

–

–

3,614

Restructuring costs

69

–

69

–

–

Other (income) expense, net

(35)

(3)

–

(107)

75

GAAP Expense, EPS and Related Information
Gross margin was 74.2% for the first quarter of 2026 compared with 78.0% for the first quarter of 2025. The decrease was primarily due to higher amortization of intangible assets, higher restructuring costs, the recognition of inventory fair value step-up related to the 2025 Verona Pharma acquisition and the unfavorable impact of foreign exchange, partially offset by favorable product mix.

Selling, general and administrative (SG&A) expenses were $2.7 billion in the first quarter of 2026, an increase of 6% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange.

Research and development (R&D) expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending, the unfavorable impact of foreign exchange and restructuring costs, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone Life Sciences (Blackstone) and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBiotech Limited (EyeBio).

Other (income) expense, net, was $138 million of expense in the first quarter of 2026 compared with $35 million of income in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities.

The income tax provision for the first quarter of 2026 was $709 million on a pretax loss of $3.5 billion, resulting in an effective income tax rate of (20.1)%. This effective income tax rate includes a 33.1 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded.

GAAP loss per share was $1.72 for the first quarter of 2026 compared with earnings per share of $2.01 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara.

Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 81.9% for the first quarter of 2026 compared with 82.2% for the first quarter of 2025. The decrease was primarily due to the unfavorable impact of foreign exchange, partially offset by favorable product mix.

Non-GAAP SG&A expenses were $2.7 billion in the first quarter of 2026, an increase of 5% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange.

Non-GAAP R&D expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending and the unfavorable impact of foreign exchange, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBio.

Non-GAAP other (income) expense, net, was $318 million of expense in the first quarter of 2026 compared with $75 million of expense in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense.

The non-GAAP income tax provision for the first quarter of 2026 was $957 million on a pretax loss of $2.2 billion, resulting in a non-GAAP effective income tax rate of (43.5)%. This effective income tax rate includes a 57.6 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded.

Non-GAAP loss per share was $1.28 for the first quarter of 2026 compared with earnings per share of $2.22 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara.

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

First Quarter

$ in millions, except EPS amounts

2026

2025

EPS

GAAP EPS

$(1.72)

$2.01

Difference

0.44

0.21

Non-GAAP EPS that excludes items listed below3

$(1.28)

$2.22

Net (Loss) Income

GAAP net (loss) income2

$(4,240)

$5,079

Difference

1,084

532

Non-GAAP net (loss) income that excludes items listed below2,3

$(3,156)

$5,611

Excluded Items:

Acquisition- and divestiture-related costs4

$1,046

$647

Restructuring costs

466

105

Income from investments in equity securities

(180)

(107)

Increase to net loss / decrease to net income before taxes

1,332

645

Estimated income tax benefit5

(248)

(113)

Increase to net loss / decrease to net income

$1,084

$532

Pipeline and Portfolio Highlights
In the first quarter, the Company continued to advance its pipeline, achieving significant regulatory and clinical milestones across a broad range of therapeutic areas.

Oncology:
U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX plus paclitaxel, with or without bevacizumab, for the treatment of certain adults with PD-L1+ (combined positive score [CPS] ≥1) platinum-resistant ovarian cancer, based on Phase 3 KEYNOTE-B96 trial.
The European Commission (EC) also approved this KEYTRUDA regimen for this population.
In April, FDA approved a label update for KEYTRUDA QLEX based on results from Phase 2 MK-3475A-F11 trial, which evaluated patient-reported preference for subcutaneous administration of KEYTRUDA QLEX over intravenous administration of KEYTRUDA in participants with multiple tumor types.
In April, FDA granted priority review for ifinatamab deruxtecan (I-DXd) for certain adults with previously treated extensive-stage small cell lung cancer, based on Phase 2 Ideate-Lung01 trial. I-DXd is part of the Company’s collaboration with Daiichi Sankyo.
FDA set Prescription Drug User Fee Act (PDUFA) date of Oct. 10, 2026.
FDA accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX for the adjuvant treatment of certain patients with RCC, based on the Phase 3 LITESPARK-022 trial.
FDA set PDUFA date of June 19, 2026.
FDA accepted supplemental applications for WELIREG plus Lenvima in certain previously treated patients with advanced RCC, based on the Phase 3 LITESPARK-011 trial. Lenvima is being developed as part of a collaboration with Eisai Co., Ltd (Eisai).
FDA set PDUFA date of Oct. 4, 2026.
Announced positive results from Phase 3 KEYNOTE-B15 trial (also known as EV-304) demonstrating KEYTRUDA plus Padcev reduced the risk of event-free survival (EFS) events by 47% and reduced the risk of death by 35% in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC) when given before and after surgery.
KEYNOTE-B15 is the sixth study demonstrating overall survival (OS) with a KEYTRUDA-based regimen in an earlier-stage cancer.
In April, FDA granted priority review for KEYTRUDA and KEYTRUDA QLEX, each with Padcev, for cisplatin-eligible patients with MIBC, based on the Phase 3 KEYNOTE-B15 trial.
FDA set PDUFA date of Aug. 17, 2026.
In a pre-specified interim analysis of the Phase 3 LITESPARK-012 study, compared to KEYTRUDA plus Lenvima, the triplet combination therapy of KEYTRUDA plus Lenvima plus WELIREG, as well as the combination of MK-1308A (an investigational fixed dose coformulation of KEYTRUDA and the anti-CTLA-4 antibody quavonlimab) plus Lenvima, did not show a statistically significant improvement in the primary endpoints of progression-free survival and OS in patients with advanced clear cell RCC.
In the Phase 3 KEYNOTE-975 study, compared to placebo plus definitive chemoradiotherapy (dCRT), KEYTRUDA plus dCRT did not show a statistically significant improvement in the primary endpoint of EFS in certain patients with locally advanced unresectable esophageal carcinoma.
In a prespecified interim analysis of the Phase 3 KEYNOTE-866 study, compared to perioperative placebo plus neoadjuvant chemotherapy, perioperative KEYTRUDA plus neoadjuvant chemotherapy did not show a statistically significant improvement in the primary endpoint of EFS in patients with cisplatin-eligible MIBC who underwent radical cystectomy and pelvic lymph node dissection.
Vaccines and Infectious Diseases:
In April, FDA approved once-daily IDVYNSO, an oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of certain adults with virologically suppressed HIV-1, based on Phase 3 MK-8591A-051 and MK-8591A-052 trials. IDVYNSO was also approved in Japan for these patients in March.
Presented data from three Phase 3 trials evaluating DOR/ISL at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI), including:
Results from Phase 3 MK-8591A-053 trial demonstrated that DOR/ISL is the first two-drug regimen that does not include an integrase strand transfer inhibitor to demonstrate non-inferiority and similar safety profile at Week 48 versus bictegravir/emtricitabine/tenofovir alafenamide6 [(50 mg/200 mg/25 mg) (BIC/FTC/TAF)] in adults living with HIV-1 who had not previously received antiretroviral treatment.
Results from the Phase 3 MK-8591A-052 and MK-8591A-051 trials demonstrated that DOR/ISL maintained virologic suppression at Week 96 in adults with virologically suppressed HIV-1 who switched from other antiretroviral therapies, including BIC/FTC/TAF.
In April, EC approved ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season, based on Phase 2b/3 CLEVER and Phase 3 SMART trials.
Announced positive second RSV season results from Phase 3 SMART trial evaluating the safety, efficacy and pharmacokinetics of ENFLONSIA in infants and children at increased risk for severe RSV disease over two RSV seasons.
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinion for an expanded indication for CAPVAXIVE for active immunization against invasive pneumococcal disease and pneumococcal pneumonia in certain children and adolescents at increased risk of pneumococcal disease.
Cardiometabolic and Respiratory:
Presented new data at the American College of Cardiology’s Annual Scientific Session and Expo (ACC.26) including:
Positive results from Phase 3 CORALreef AddOn trial demonstrated significantly greater LDL-C reductions at eight weeks compared to guideline-recommended oral non-statin therapies when added to background statins. This is the third positive Phase 3 study of enlicitide.
Positive data from Phase 2 CADENCE trial provided definitive proof-of-concept for WINREVAIR in adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF). Totality of evidence supports advancing development of WINREVAIR for this distinct patient population into a registrational Phase 3 study.
Animal Health:
FDA approved NUMELVI for dogs, the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older.
Business Development:
Announced an agreement to acquire Terns Pharmaceuticals, Inc. (Terns) through a subsidiary.
Expands hematology pipeline with the addition of TERN-701, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor currently in Phase 1/2 development for certain patients with chronic myeloid leukemia (CML).
Transaction expected to close in May.
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

KEYTRUDA and KEYTRUDA QLEX, Plus Paclitaxel ± Bevacizumab, FDA Approved for Certain Adults With PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma as Second- or Third-Line Treatment; Based on Results From Phase 3 KEYNOTE-B96 Trial

EC Approved KEYTRUDA Plus Paclitaxel ± Bevacizumab for Treatment of Adults With PD-L1 (CPS ≥1) Platinum-Resistant Recurrent Ovarian Carcinoma Who Have Received One or Two Prior Systemic Treatment Regimens; Based on Results From Phase 3 KEYNOTE-B96 Trial

I-DXd Granted Priority Review in U.S. for Adult Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer Who Experienced Disease Progression on or After Platinum-Based Chemotherapy; Based on Results From Phase 2 Ideate-Lung01 Trial; FDA Set PDUFA Date of Oct. 10, 2026

FDA Granted Priority Review for KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, for Cisplatin-Eligible Patients With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial; FDA Set PDUFA Date of Aug. 17, 2026

KEYTRUDA Plus Padcev Reduced Risk of EFS Events by 47% and Risk of Death by 35% for Cisplatin-Eligible Patients With MIBC When Given Before and After Surgery; Results From Phase 3 KEYNOTE-B15 Trial

KEYTRUDA Plus Paclitaxel With or Without Bevacizumab Significantly Improved Key Secondary Endpoint of OS Versus Paclitaxel With or Without Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer; Results From Phase 3 KEYNOTE-B96 Trial

KEYTRUDA Plus WELIREG Given as Adjuvant Therapy Reduced Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Patients With Earlier-Stage RCC; Results From Phase 3 LITESPARK-022 Trial; FDA Set PDUFA Date of June 19, 2026 for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX

WELIREG Plus Lenvima Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With RCC; Results From Phase 3 LITESPARK-011 Trial; FDA Set PDUFA Date of Oct. 4, 2026

The Company and Eisai Provided Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced RCC

Vaccines and
Infectious Diseases

FDA Approved the Company’s Once-Daily IDVYNSO for Adults With Virologically Suppressed HIV-1; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials

The Company Announced Late-Breaking Data From Three Phase 3 Trials Evaluating DOR/ISL, an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults Living With HIV-1, at CROI 2026

EC Approved ENFLONSIA for the Prevention of RSV Lower Respiratory Tract Disease in Infants During Their First RSV Season; Based on Results From Phase 2b/3 CLEVER and Phase 3 SMART Trials

The Company Announced Positive New Data for ENFLONSIA for Infants and Children Under 2 Years of Age at Increased Risk for Severe RSV Disease Over Two RSV Seasons; Results From Phase 3 SMART Trial

The Company Presented New Data Reinforcing Long-Term Efficacy of GARDASIL 9 and GARDASIL at the EUROGIN International Multidisciplinary HPV Congress 2026

Cardiometabolic and
Respiratory

Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins; Results From Phase 3 CORALreef AddOn Trial

Positive Data From Phase 2 CADENCE Trial Provided Definitive Proof-of-Concept for WINREVAIR in Adults With the Syndrome of CpcPH-HFpEF

Ophthalmology

The Company Initiated Pivotal Phase 2b/3 Trial Evaluating MK-8748, an Investigational Bispecific Tie2 Agonist/VEGF Inhibitor, for the Treatment of Neovascular Age-Related Macular Degeneration

Animal Health

FDA Approved NUMELVI for Dogs – First and Only Second-Generation JAK Inhibitor for the Control of Pruritus Associated With Allergic Dermatitis

Research

The Company and Mayo Clinic Announced New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine

The Company and Google Cloud Partnered To Accelerate Agentic AI Enterprise Transformation

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

Upcoming Investor Event
The Company will hold an Oncology Investor Event to coincide with the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Monday, June 1, 2026, 6 p.m. CT, during which senior management will provide an update on the Company’s oncology strategy and program. The event will take place in Chicago 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*

$65.8 billion to $67.0 billion

$65.5 billion to $67.0 billion

Non-GAAP Gross margin3

Approximately 82%

Approximately 82%

Non-GAAP Operating expenses3**

$36.0 billion to $36.8 billion

$35.9 billion to $36.9 billion

Non-GAAP Other (income) expense, net3

Approximately $1.3 billion expense

Approximately $1.3 billion expense

Non-GAAP Effective income tax rate3

23.5% to 24.5%

23.5% to 24.5%

Non-GAAP EPS3***

$5.04 to $5.16

$5.00 to $5.15

Share count (assuming dilution)

Approximately 2.48 billion

Approximately 2.48 billion

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

**Includes a one-time charge of $9.0 billion for the acquisition of Cidara. Outlook does not reflect the proposed acquisition of Terns or assume any additional significant potential business development transactions.

***Includes a one-time charge of $3.62 per share for 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 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 now anticipates full-year 2026 sales to be between $65.8 billion and $67.0 billion, including a positive impact from foreign exchange of approximately 1% at mid-April 2026 exchange rates.

The Company continues to expect the full-year non-GAAP effective income tax rate 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 now expects full-year 2026 non-GAAP EPS to be between $5.04 and $5.16, including a positive impact from foreign exchange of approximately $0.10 per share at mid-April 2026 exchange rates. This range includes a one-time charge of $9.0 billion, or $3.62 per share, 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 in the aggregate related to certain business development transactions.

In April 2026, the Company announced a tender offer to acquire Terns. The Company’s financial outlook does not reflect this transaction, which is expected to be accounted for as an asset acquisition and result in a one-time charge of approximately $5.8 billion, or approximately $2.35 per share. In addition, taking into consideration operational investment to advance TERN-701, as well as the cost of financing the transaction, the Company also anticipates EPS will be negatively impacted by approximately $0.12 over the remainder of 2026 following the close, which is expected in May.

The financial outlook does not assume additional significant potential business development transactions.

Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call on Thursday, April 30, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website.

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

(Press release, Merck & Co, APR 30, 2026, View Source [SID1234664972])

On April 30, 2026 Agendia, Inc., a leader in precision oncology for breast cancer, reported it will present new data at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress on Breast Cancer, taking place May 6-8 in Berlin, Germany. The company will present two posters featuring data from the prospective FLEX Study and an independent post hoc analysis of the landmark MINDACT trial that underscore the prognostic value of MammaPrint + BluePrint in early-stage breast cancer (EBC).

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Poster #65P | Thursday, May 7, 13:15 – 14:15 p.m. CEST | Presenter: Elena Shagisultanova

Prognostic Performance of MammaPrint in Patients with Small T1a, b, and c Node-Negative Early Breast Cancer

A retrospective analysis from the FLEX Study involving 4,349 patients highlights the biological heterogeneity within small, node-negative (T1a, b, and c) tumors – a group that typically has favorable outcomes.

MammaPrint (MP) identified a High Risk 2 (H2) subset, representing 10% of all patients and 5% of those with HR+HER2- disease who experienced significantly worse recurrence-free survival (RFS) compared to those with High-Risk 1 (H1) or Low/UltraLow Risk (LR/UL) tumors.
Among all patients, the 3-year RFS was 93% for MP H2 versus 98% for the LR/UL group, while in the HR+HER2- subgroup, MP H2 tumors had a 3-year RFS of 91% compared to 98% for the LR/UL group.
These findings highlight the prognostic value of MP in clinically small EBC, suggesting that a subset of T1N0 patients may benefit from escalated therapy or biology-informed treatment approaches.
"These findings highlight the prognostic value of MammaPrint in small, node-negative breast cancers," said William Audeh, MD, Chief Medical Officer of Agendia. "While this group of patients are generally regarded as having a favorable prognosis, our data reveal a distinct subset with high-risk biology who may benefit from escalated therapy and biology-informed treatment approaches that might have otherwise been overlooked based on tumor size alone."

Poster #71P | Thursday, May 7, 13:15 – 14:15 p.m. CEST | Presenter: Giacomo Biganzoli

Associations of body mass index with distant recurrence dynamics in the MINDACT trial

This exploratory analysis from the MINDACT trial, co-authored by Agendia co-founder and MammaPrint inventor Laura van ‘t Veer, PhD, analyzed the relationship between body mass index (BMI) and distant metastasis risk (DMR) dynamics in ER+/HER2- breast cancer.

Higher BMI was not linearly associated with worse outcomes in this cohort; patients with obesity showed a lower DMR (HR 0.36) compared to those with normal weight.
For patients with a BMI between 24–28, DMR dynamics showed a peak at 6 years, followed by a rapid decline.
The non-monotonic relationship between DMR and BMI warrants further investigation in large trials to optimize time-dependent management strategies.

(Press release, Agendia, APR 30, 2026, View Source [SID1234664990])

On April 30, 2026 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, reported financial and corporate updates for the quarter ended March 31, 2026.

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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "The progress in our collaborations with Takeda and Eli Lilly reflect great confidence in our anti-Abeta active immunotherapy and Tau aggregation inhibitor small molecules, respectively. These have the potential to change the way we target the proteinopathies that drive Alzheimer’s and other neurodegenerative diseases (NDDs). This is further exemplified by the presentation of the interim results for ACI-7104 at AD/PD 2026 showing that our active immunotherapy targeting a-synuclein (a-syn) has the potential to modify disease pathology in Parkinson’s disease (PD). We also advanced our NLRP3 inhibitor ACI-19764 into clinical development, further demonstrating the power of AC Immune’s technology to target the key pathways that contribute to neurodegeneration.

"We are now moving towards multiple value inflection points during 2026. These include Phase 2 data readouts on our active immunotherapies ACI-7104 and ACI-24, and initial results from the Phase 1 trial of ACI-19764 also anticipated this year."

Q1 2026 and Subsequent Highlights:

ACI-24 anti-Abeta active immunotherapy

· As announced separately today, AC Immune has initiated the final cohort, AD4, in the ongoing Phase 1b/2 ABATE trial of ACI-24 to treat Alzheimer’s Disease

· Treatment of the first patient in cohort AD4 triggers a $12 million milestone payment from Takeda

Morphomer-Tau small molecule program

· Amended agreement with Eli Lilly and Co. (Lilly) reflects growing excitement for targeting intracellular Tau and significant progress with our Morphomer small molecules

· The amendment continues the research and collaboration to cover development of new lead Tau Morphomer candidates and potential back-up compounds.

· Under this amendment, AC Immune receives a CHF10 million upfront payment (Q2 2026 event) and a subsequent milestone payment subject to Phase 1 dosing, in addition to milestones announced in a prior amendment. AC Immune is eligible for further development, regulatory and commercial milestones of over CHF1.7 billion, plus tiered percentage royalty payments in the low double digits, as previously disclosed.

· Investigational New Drug (IND)-enabling studies are expected to be initiated imminently.

ACI-7104, anti-a-syn active immunotherapy

· Presented updated interim results from Part 1 of the Phase 2 VacSYn clinical trial in early-stage Parkinson’s disease at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2026), including promising biomarker data.

· Interim results previously presented include changes in biomarkers and clinical measures all suggesting potential disease modification through treatment with ACI-7104

· Final results for the week 104 full data set from Part 1 of the VacSYn trial expected to be reported in H2 2026.

NLRP3 inhibitor, ACI-19764, small molecule program

· Dosed the first subjects in a Phase 1 clinical trial of ACI-19764, a brain-penetrant Morphomer small molecule targeting the NLRP3 inflammasome.

· Morphomer NLRP3 inhibitors have potential to intervene at the earliest stages of disease in neurodegenerative conditions, including AD, PD, amyotrophic lateral sclerosis (ALS) and frontotemporal dementia.

· Potential additional indications include inflammatory disorders, cardiovascular disease, metabolic disorders, skin inflammatory diseases, and certain rare diseases, among others.

ACI-35 (JNJ-2056) anti-pTau active immunotherapy

· AC Immune’s partner Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, is seeking a protocol amendment for the ReTain study to enable earlier insights into the biological activity of JNJ-2056 and its potential for clinical benefit. Submissions to all relevant health authorities are ongoing.

· The study remains active, with enrollment paused, and there is no change for enrolled participants at this time.

· The study is ongoing based on ~60 enrolled patients with a minimum of 12 months and up to 24 months of treatment and follow-up.

TDP-43 PET tracer

· Presented Phase 1 data including the first in vivo images of TDP-43 pathology in the human brain, detected using its first-in-class positron emission tomography (PET) tracer ACI-19626, at the International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD 2026).

· Initial Phase 1 data (PET scans) with ACI-19626 showed that tracer uptake was significantly higher in key regions of the brain in patients with frontotemporal dementia (FTD) and we are currently evaluating the tracer in ALS patients.

· Clinical data indicate a pharmacokinetic (PK) profile suitable for human brain imaging and potentially pharmacodynamic analysis of therapeutics targeting TDP-43 pathology.

AC Immune AD/PDTM 2026 symposium

· Hosted an industry symposium on achieving precision prevention in Parkinson’s disease, highlighting Phase 2 clinical data on our ACI-7104 active immunotherapy, our small molecule programs targeting intracellular alpha-synuclein, and innovative diagnostic approaches to identifying at-risk individuals.

Anticipated 2026 Milestones

Program Milestone Expected in
ACI-7104.056
anti-a-syn active immunotherapy Final data from Part 1 of the Phase 2 VacSYn trial in PD H2 2026
ACI-24.060
anti-Abeta active immunotherapy Interim results from ABATE Phase 2 trial after reaching 12-month treatment timepoint in the AD3 cohort H1 2026
ACI-19764
NLRP3 inhibitor Results from Phase 1 trial in healthy volunteers H2 2026
Morphomer-Tau aggregation inhibitors Initiation of IND-enabling studies H1 2026
Morphomer a-syn aggregation inhibitor Lead declaration H1 2026

Analysis of Financial Statements for the Quarter Ended March 31, 2026

· Cash Position: The Company had total cash resources of CHF 74.8 million (CHF 91.4 million as of December 31, 2025), composed of CHF 19.2 million in cash and cash equivalents and CHF 55.6 million in short-term financial assets. The Company’s cash resources are expected to provide sufficient capital to last into Q4 2027, excluding potential milestone payments.

· R&D expenditures: R&D expenses for the three months ended March 31, 2026, were CHF 11.8 million, compared with CHF 15.9 million for the comparable period in 2025. The decrease was partly due to lower personnel and operational spend of approximately CHF 1.7 million as a result of our pipeline focus initiatives announced in Q3 2025, as well as lower spend associated with our active immunotherapy programs, particularly in the upfront CMC costs prior to initiation of phase 2 studies.

· G&A expenditures: G&A expenses in the period were CHF 4.2 million in the period ended March 31, 2026, compared to CHF 4.4 million for same period in 2025.

· Financial result: The financial result was a loss of less than CHF 0.1 million for the period, compared with a gain of CHF 0.3 million for the comparable period. The change was primarily driven by a decrease in interest income earned on short-term financial assets, partially offset by lower foreign exchange losses.

· IFRS loss for the period: The Company had a net loss of CHF 14.8 million for the period ended March 31, 2026, compared to CHF 19.0 million for the same period in 2025.

(Press release, AC Immune, APR 30, 2026, View Source [SID1234664957])

On April 30, 2026 Oxcia AB reported that the abstract "Interim results of the phase I/II study investigating karonudib in patients with refractory hematological malignancies paired with ex-vivo precision screen drug sensitivity screening" has been selected by the European Hematological Association (EHA) (Free EHA Whitepaper) Scientific Program Committee for a poster presentation during the EHA (Free EHA Whitepaper)2026 Congress. The congress takes place in Stockholm this year, June 11-14th. Stefan Deneberg, Principal Investigator of the clinical study and Austin Smith, Oxcia’s Chief Medical Officer, will present the interim results.

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The overall aim of the clinical study is to build on early encouraging signals of clinical activity and generate the data required to support a pivotal Phase II program in Acute Myeloid Leukemia. The on-going expansion group in the OXC-101 and idarubicin combination has expanded to Denmark and Serbia to facilitate timely recruitment.

OXC-101 (karonudib) has, as previously communicated, been granted ODD status by both the EMA and the FDA for Acute Myeloid Leukemia.

(Press release, Oxcia, APR 30, 2026, View Source;utm_medium=rss&utm_campaign=oxc-101-for-aml-accepted-to-be-presented-at-eha [SID1234664973])

On April 30, 2026 Curocell (KOSDAQ: 372320) reported that RIMQARTO Inj. (anbalcabtagene autoleucel), South Korea’s first domestically developed CAR T-cell therapy, has secured full regulatory approval from the Ministry of Food and Drug Safety (MFDS) on April 29. With this approval, RIMQARTO becomes the 42nd drug domestically developed under the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products for manufacture and sale. This represents the first commercialization of CAR T-cell therapy by a Korean company.

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The CAR T-cell therapy is a personalized autologous T-cell immunotherapy in which a patient’s immune cells are genetically modified to selectively target cancer cells. RIMQARTO has drawn attention as a next-generation CD19 CAR T-cell therapy powered by Curocell’s proprietary OVIS (Overcome Immune Suppression) technology. This technology is designed to regulate immunosuppressive signals in the tumor microenvironment, addressing "T-cell exhaustion," and enabling more sustained anticancer activity over the long term.

RIMQARTO is indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adults following two or more lines of systemic therapy.

In the pivotal Phase 2 trial supporting the approval, RIMQARTO achieved an objective response rate (ORR) of 75.3% and a complete response (CR) rate of 67.1%. The therapy also showed its safety profile, with cytokine release syndrome (CRS), a key adverse event associated with CAR T-cell therapy, reported in 10% of patients, and immune effector cell-associated neurotoxicity syndrome (ICANS) reported in 5%.

Although RIMQARTO was initially submitted for conditional approval, the MFDS waived the requirement for Phase 3 trial data during the review process, taking into account its use as a third-line treatment for lymphoma and its classification as a novel CAR T-cell therapy. As with other global CAR T-cell therapies, the approval is subject to long-term follow-up studies and risk management plans to monitor the therapy’s safety and efficacy.

The approval reflects the combined impact of the MFDS’s expedited review framework and full-cycle support from government R&D programs. RIMQARTO was developed with support from the Ministry of Health and Welfare (MOHW) R&D program and the Korea Drug Development Fund. In addition, the MFDS’s "Bio-Challenger Program" for advanced biopharmaceuticals and RIMQARTO’s "Global Innovative Products on Fast Track" (GIFT) and fast-track processing designations enhanced both efficiency and speed throughout the development and approval review processes.

RIMQARTO was also selected for the MOHW’s "Concurrent Pilot Program for Approval-Evaluation-Negotiation," which is expected to shorten the timeline from its approval to national health insurance reimbursement listing.

Curocell CEO Kim Gun-soo said, "The latest approval is a milestone in Korea’s new drug development history. We would like to express our gratitude to everyone who has worked tirelessly to make this achievement possible. We have been researching because CAR T-cell technology was not available in Korea. We have now secured our first new drug approval. With the capabilities and experience accumulated so far, we are committed to advancing the global success of Korea’s CAR-T technology."

Building on RIMQARTO, Curocell plans to pursue indication expansion, global market entry, and the development of next-generation pipelines, while further demonstrating the scalability of its CAR-T platform by expanding into solid tumors and autoimmune diseases.

(Press release, Curocell, APR 30, 2026, View Source [SID1234664991])