Merck : Icon 1Q26 Merck Earnings Presentation

MRK

Published on 04/30/2026 at 06:48 am EDT

‌First-Quarter 2026 Sales and Earnings

Merck & Co., Inc., Rahway, N.J., USA

April 30, 2026

‌Strategy and Business Update

Robert M. Davis

Chairman and Chief Executive Officer

Financial Results and Outlook

Caroline Litchfield

Agenda

Executive Vice President and Chief Financial Officer

Research Update

Dr. Dean Y. Li

Executive Vice President and President, Research Laboratories

Question & Answer Session

Agenda

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

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

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2025 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (https://www.sec.gov).

Forward-looking statement of Merck & Co., Inc., Rahway, N.J., USA

‌Strategy and Business Update

Robert M. Davis

Chairman and Chief Executive Officer

‌Achieved significant pipeline and regulatory progress:

Oncology

FDA accepted four filings across oncology portfolio including new BLA for ifinatamab deruxtecan1 for priority review in SCLC

Infectious Diseases

FDA approved once-daily IDVYNSO, a new, two-drug single-tablet regimen of doravirine and islatravir for certain adults with virologically suppressed HIV-1

Cardiometabolic & Respiratory

Presented results from new studies evaluating enlicitide and

WINREVAIR at ACC 2026

Ophthalmology

Initiated pivotal Phase 2b/3 studies evaluating MK-8748, a TIE-2/VEGF bispecific antibody, in NVAMD

Animal Health

¹Weber Shandwick/KCR Research, 2020 / AMO 2019

FDA approved NUMELVI, the first and only second-generation JAK inhibitor for allergic dermatitis in dogs

Q1 Worldwide Sales

$16.3B

+5% nominal

+3% ex-exchange

Strength in Oncology and Animal Health

Increasing contributions from new launches

‌Science-driven business development that strengthens and complements hematology pipeline

Adds TERN-701, an investigational next-generation, allosteric TKI

for treatment of certain patients with chronic myeloid leukemia

Potential best-in-class profile with opportunity to further improve depth and duration of response in certain patients

Multibillion dollar commercial opportunity and growth driver in the next decade, creating shareholder value

6

1. Transaction expected to close in May

Announced strategic acquisition1 of Terns Pharmaceuticals

‌Advancing Diverse & Expansive Pipeline

~80 Phase 3 studies ongoing

Launching New Growth Drivers

Expect >20 new growth drivers, almost all of which have blockbuster potential

Executing Business Development

Actively pursuing additional science-driven, value-creating transactions

Significant commercial opportunity

Potential commercial opportunity of >$70B1 from new growth drivers alone by the mid-2030s

1. Non-risk adjusted annual sales by the mid-2030s 7

Transforming our portfolio with next wave of innovation

‌Financial Results and Outlook

Caroline Litchfield

Executive Vice President and Chief Financial Officer

+5% nominal

+3% ex-exchange

+5% growth

+2% ex-exchange

+13% growth

+6% ex-exchange

Q1 worldwide performance driven by demand for our innovative portfolio

‌KEYTRUDA family1 sales of $8.0B increased 8%, driven by strong demand from metastatic indications and robust uptake in earlier-stage cancers

Growth driven by usage in tumors predominantly affecting women, including those with certain breast and cervical cancers

Increased use of KEYTRUDA in combination with enfortumab vedotin in locally advanced or metastatic urothelial cancer

In the U.S., growth benefitted by ~$250M due to timing of wholesaler purchases

KEYTRUDA QLEX sales of $128M in 1Q26 following launch in 3Q25; permanent J-code effective April 1st

$8.0B

+8%

$7.2B

+6%

$6.9B

+24%2

1Q24 1Q25 1Q26

Oncology: KEYTRUDA continues to benefit patients and drive growth

$199M

+43%

$137M

+63%

+102%

‌WELIREG sales grew 43%, driven by continued launch uptake in international markets and higher demand in the U.S.

Lynparza1 alliance revenue grew 6%, primarily due to higher demand in the U.S. and many international markets

Lenvima2 alliance revenue declined 2%

$85M

1Q24 1Q25 1Q26

$341M

+6%

$312M

+8%

$292M

+7%

1Q24 1Q25 1Q26

$258M

+2%

$256M

-2%

$255M

+10%

Oncology: Continued impact for patients across broad portfolio

‌GARDASIL sales of $1.1B decreased 22%, driven by lower demand in China and Japan, consistent with expectations

In the U.S., sales declined 10% primarily due to the timing of CDC purchases, partially offset by price

CAPVAXIVE1 sales of $142M increased 31% driven by uptake from ongoing launches in certain international markets

In the U.S., growth was driven by increased demand from both retail pharmacies and non-retail customers, partially offset by a reduction in wholesaler inventory

$2.2B

+17%

$1.3B

-40%

$1.1B

-22%

1Q24 1Q25 1Q26

$142M

+31%

$107M

1Q24 1Q25 1Q26

Vaccines & Infectious Diseases: Protecting lives globally

‌WINREVAIR1 sales of $525M driven by continued growth in new patient starts and total prescriptions

In the U.S., >1,600 new patients prescribed and

>29,500 total prescriptions dispensed

Ex-U.S., making progress with approvals and reimbursement

OHTUVAYRE2 sales of $131M reflect strong growth in total prescriptions

Sequential sales decline due to Medicare deductible resets and CMS reimbursement change

$525M

+87%

$280M

1Q24 1Q25 1Q26

$71M3

$131M

1Q24 1Q25 1Q26

Cardiometabolic & Respiratory: Continuing to drive impact for patients with successful ongoing launches

‌Animal Health sales increased 6% to $1.8B

Livestock sales grew 8%, driven by higher demand for ruminant and poultry products as well as price

$1.8B

+6%

$1.6B

+10%

$1.5B

+4%1

Companion Animal sales grew 4% driven by new product launches and price, partially offset by lower demand for other products in portfolio due to lower vet visits

1Q24 1Q25 1Q26

Animal Health: Strong growth driven by livestock and companion animal

‌Q1 2026

Q1 2025

Change

Change Ex-FX

Sales

$16.3

$15.5

+5%

+3%

Non-GAAP Gross Margin

81.9%

82.2%

-0.3 pts

+0.1 pts

Non-GAAP Operating Expenses2

$15.2

$6.1

N/M

N/M

Non-GAAP Tax Rate

-43.5%

14.2%

N/M

N/A

Non-GAAP (Loss) / Earnings Per Share3,4

$(1.28)

$2.22

N/M

N/M

1. The company is providing certain 2026 and 2025 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors' understanding of the company's results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, annual employee compensation, including senior management's compensation, is derived in part using a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to the earnings release. 2. Q1 2026 non-GAAP results include a charge of

Q1 2026 non-GAAP financial results summary1

$ in billions, except LPS / EPS amounts

‌Prior Guidance

Updated Guidance

Key Assumptions

Revenue

$65.5B to $67.0B

$65.8B to $67.0B

Assumes ~1 percentage point positive impact from FX

Implies +1% to +3% nominal (+0% to +2% ex-FX)

Non-GAAP

Gross Margin Rate

~82.0%

~82.0%

Non-GAAP

Operating Expenses1, 2

$35.9B to $36.9B

$36.0B to $36.8B

Includes $9B charge related to acquisition of Cidara

Other (Income) / Expense

~$1.3B of expense

~$1.3B of expense

Includes financing costs related to acquisitions of Verona and Cidara

Tax Rate

~23.5% to 24.5%

~23.5% to 24.5%

Includes impact of non-tax deductible charge for Cidara

Shares Outstanding

~2.48B

~2.48B

Assumes ~3B of share repurchases

Non-GAAP EPS1,2

$5.00 to $5.15

$5.04 to $5.16

Includes ~$3.62 negative impact related to upfront charge for acquisition of Cidara

Assumes ~$0.10 positive impact from FX

Updated 2026 financial outlook

‌KEYTRUDA

ENFLONSIA

SG&A

In the U.S., expect headwind from timing of wholesaler purchases in 3Q

Anticipate minimal sales in 2Q given expected seasonality and continued high levels of RSV mAb inventory in marketplace

Expect expenses to increase over remainder of year due to investment in launches

Key modeling considerations

‌Capital allocation order of priority

$9.1

$3.1

$2.1

$1.0

$0.9

Augmented our pipeline and portfolio with value-enhancing business development while investing in our pipeline and business as well as returning cash to shareholders

2

After-Tax R&D

CapEx Dividends Paid

Business Development (ex-divestitures)

Share Repurchase

Remain committed to balanced capital allocation strategy

Q1 Spend ($ in billions)1

‌Research Update

Dr. Dean Y. Li

Executive Vice President and President, Research Laboratories

‌Enlicitide

Phase 3 results support ambition to bring first approved oral PCSK9i designed to have antibody-like

LDL-C lowering to a broad population globally

-58.2

Percent LDL-C reduction from baseline as demonstrated:

-57.11

-59.62

2026 AHA/ACC Multisociety Guidelines3

Updated guidelines support early and aggressive treatment to reduce lifetime cumulative LDL-C exposure and restore concrete targets

Key goals include:

<55 mg/dL for very high risk ASCVD

<70 mg/dL for high risk ASCVD and primary prevention patients with PREVENT score >10

Most patients with ASCVD will qualify for an LDL-C goal of <55 mg/dL

WINREVAIR

Totality of evidence from Phase 2 CADENCE study provides strong rationale for Phase 3 development in CpcPH-HFpEF

Robust primary endpoint4 results at 0.3mg/kg dose:

PVR

-1.02 Wood units

6MWD5

+20.3 meters

TTCW5

Prolonged TTCW (HR: 0.18)

Additional findings from exploratory secondary endpoints at 0.3mg/kg dose include:

-64.6

1. Per statistical analysis plan 2. Reanalysis (post-hoc) conducted to remove imputed biologically impossible baseline values 3. Blumentahl, et al., (2026) Circulation, 153. Published online March 13, 2026.

Important updates across cardiometabolic and respiratory portfolio

‌KEYTRUDA

KEYNOTE-B96: FDA and EC

approved KEYTRUDA in combination with paclitaxel, with or without bevacizumab, for treatment of PD-L1+ cisplatin-resistant ovarian cancer

KEYNOTE-B151: Findings showed perioperative KEYTRUDA in combination with enfortumab vedotin reduced risk of EFS events by 47% and risk of death by 35% vs neoadjuvant chemotherapy2 for treatment of cisplatin-eligible MIBC

- Sixth study of KEYTRUDA-based regimen to demonstrate OS in earlier stage cancer

PDUFA date August 17, 2026

WELIREG

LITESPARK-022: WELIREG plus

KEYTRUDA demonstrated a 28% reduction in the risk of disease recurrence or death compared to KEYTRUDA alone in adjuvant RCC setting

PDUFA date June 19, 2026

LITESPARK-011: WELIREG plus

Lenvima3 demonstrated a 30% reduction in the risk of disease progression or death versus cabozantinib in previously treated advanced RCC with disease progression on or after anti PD-1/PD-L1 therapy

PDUFA date October 4, 2026

I-DXd4

Announced priority review for BLA filing based on Phase 2 IDeate-Lung01 and Phase 1/2 IDeate-Pan Tumor01 trials for extensive-stage SCLC with disease progression on or after platinum-based chemotherapy

PDUFA date October 10, 2026

Continuing to advance cancer care with broad portfolio and pipeline

‌Chronic myeloid leukemia

Bone marrow cancer driven by BCR::ABL fusion gene

Advances in treatment have transformed CML to chronic disease that can require life-long treatment

Significant unmet need remains for improved efficacy, safety and convenience

Quality of life and long-term tolerability increasingly important goals as treatment duration extends

TERN-701

Potent, oral, next-generation allosteric BCR::ABL TKI

Highly selective, with a novel binding site

Potential best-in-class efficacy

Terns Pharmaceuticals acquisition1 expands hematology pipeline

‌HIV

FDA and MHLW approved IDVYNSO for treatment of HIV-1 infection in adults who are virologically suppressed

First two-drug regimen without an HIV integrase strand inhibitor to demonstrate non-inferior efficacy and a generally comparable safety profile versus bictegravir / emtricitabine / tenofovir alafenamide

Important new treatment option as health needs of adults living with HIV change over time

RSV

Presented positive top line results for ENFLONSIA for prevention of RSV disease in infants and children under two years of age at increased risk over two seasons based on Phase 3 SMART study at RSV-VW-26

EC approved for newborns and infants during their first season

Building on our strong legacy in combatting infectious diseases

‌MK-8748

Potential first-in-class bispecific inhibiting VEGF and directly activating Tie2 pathway

Initial Phase 1/2a RIOJA data demonstrated MK-8748 was well tolerated with no drug-related AEs or SAEs and rapid, sustained structural and functional responses

Initiated two Phase 2b/3 studies, MALBEC and

TORRONTES, for treatment of NVAMD

Mechanism of action

Antibody binds Tie2 and VEGF aiming to stabilize blood retinal barrier and reduce free VEGF

Progressing late-stage ophthalmology pipeline

‌Oncology

ASCO Investor Event

Monday, June 1st

KEYTRUDA Family1

KEYNOTE-B152 PDUFA date August 17th

WELIREG

LITESPARK-022 PDUFA date June 19th

LITESPARK-011 PDUFA date October 4th

DXd3

IDeate-Lung013 PDUFA date October 10th

HIV

Islatravir/Lenacapavir4

Readout of Phase 3 ISLEND-1 and ISLEND-2 trials for HIV treatment

Cardiometabolic & respiratory

WINREVAIR

HYPERION PDUFA date September 21st

Enlicitide

CNPV process progressing

Immunology

Tulisokibart

PCD in August for Phase 3 ATLAS trial in UC

PCD in May for Phase 2 ATHENA trial in SSc-ILD

Ophthalmology

MK-3000

PCD in September for Phase 3 BRUNELLO trial in DME

MK-8748

Readout of Phase 2a RIOJA trial in NVAMD, DME, and RVO

Significant late-stage pipeline milestones over next six months

‌Q&A

Robert M. Davis

Chairman and Chief Executive Officer

Caroline Litchfield

Executive Vice President and Chief Financial Officer

Dr. Dean Y. Li

Executive Vice President and President, Research Laboratories

Peter Dannenbaum

Senior Vice President, Investor Relations

‌Appendix

27

‌Q1 2026

Q1 2025

Change

Change Ex-FX

Sales

$16.3

$15.5

+5%

+3%

Operating Expenses (SG&A and R&D)1

$15.3

$6.2

N/M

N/M

Tax Rate

-20.1%

13.9%

N/M

N/A

GAAP (Loss) / Earnings per Share2

$(1.72)

$2.01

N/M

N/M

Q1 2026 GAAP financial results summary

$ in billions, except LPS / EPS amounts

Capital allocation order of priority

‌Over the past 12 months

$24

$21

$18

$15

$12

$9

$6

$3

$0

$20.5

$12.7

$8.2

$4.8

$3.8

1

After-Tax R&D CapEx Dividends Paid Business

2

Development

Share Repurchase

Well-positioned balance sheet with capacity to fund additional value-enhancing business development opportunities

(ex-divestitures)

Capital investments

2025 to 2029

Committed to the dividend

+5%

+5%

Dollars per Share

Over 5 years, including more than $12B in the U.S.

+6%

+5%

+11%

+7%

+6%

+15%

+2% +2%

2017 2018 2019 2020 2021 2022 2023 2024 2025 2026E

Executing upon balanced capital allocation strategy

‌Phase 2

Phase 3

Under regulatory review

Oncology

MK-1022 (patritumab deruxtecan)1

Biliary Bladder Cervical Endometrial Esophageal Gastric

HCC

Melanoma NSCLC

Ovarian Pancreatic Prostate

MK-1084 (calderasib)1 Solid Tumors

MK-2400 (ifinatamab deruxtecan)1

Biliary Bladder Breast Cervical Endometrial HCC

HNSCC

Melanoma NSCLC

Ovarian Pancreatic Solid Tumors

MK-2870 (sacituzumab tirumotecan)1

Biliary Esophageal

Neoplasm Malignant Pancreatic

MK-3120

Bladder

KEYTRUDA (MK-3475)

Prostate

KEYTRUDA QLEX (MK-3475A)

Hematological Malignancies (U.S.)

MK-5684 (opevesostat) Breast

Endometrial Ovarian

MK-5909 (raludotatug deruxtecan)1

Cervical Endometrial Gastric NSCLC

RCC SCLC

MK-6070 (gocatamig)1 SCLC

WELIREG (MK-6482)

Breast

V940 (intismeran autogene)1 Bladder

RCC

Neuroscience

MK-1167

Alzheimer's Disease

MK-2214

Alzheimer's Disease

Cardiometabolic & Respiratory

MK-5475 PH-COPD

MK-5884A (ensifentrine + glycopyrrolate)

COPD

MK-6024 (efinopegdutide) MASH

MK-7262

Atherosclerosis

WINREVAIR (MK-7962)

Pulmonary Hypertension due to Left Heart Disease

Immunology

MK-7240 (tulisokibart) Axial Spondyloarthritis Hidradenitis Suppurativa Psoriatic Arthritis Rheumatoid Arthritis Systemic Sclerosis

MK-8690

Ulcerative Colitis

Infectious Diseases

MK-8591B (islatravir + ulonivirine)

HIV-1 Infection

Oncology

MK-1022 (patritumab deruxtecan)1

Breast

MK-1026 (nemtabrutinib) Hematological Malignancies

MK-1084 (calderasib)1 CRC

NSCLC

MK-2140 (zilovertamab vedotin)

Hematological Malignancies

MK-2400 (ifinatamab deruxtecan)1 Esophageal

Prostate SCLC (EU)

MK-2870 (sacituzumab tirumotecan)1

Bladder Breast Cervical Endometrial Gastric NSCLC

Ovarian

KEYTRUDA (MK-3475) SCLC

MK-3543 (bomedemstat) Myeloproliferative Disorders

MK-5684 (opevesostat) Prostate

MK-5909 (raludotatug deruxtecan)1

Ovarian

LYNPARZA (MK-7339)1 NSCLC

SCLC

V940 (intismeran autogene)1 Melanoma

NSCLC

Ophthalmology

MK-30004

Diabetic Macular Edema

MK-87484

Neovascular Age-Related Macular Degeneration

Vaccines

V181

Dengue Fever Virus

Cardiometabolic & Respiratory

MK-0616 (enlicitide decanoate) Hypercholesterolemia (U.S.)

Immunology

MK-7240 (tulisokibart) Crohn's Disease Ulcerative Colitis

Infectious Diseases

MK-1406

Influenza

LAGEVRIO (MK-4482)1,3 COVID-19 (U.S.)

MK-8527 HIV-1 PrEP

MK-8591A (doravirine + islatravir)

HIV-1 Infection (EU)

MK-8591D (islatravir + lenacapavir)1,2

HIV-1 Infection

Oncology

MK-2400 (ifinatamab deruxtecan)1 SCLC (U.S.)

KEYTRUDA (MK-3475)

Breast (U.S.)

Cisplatin Eligible MIBC (U.S.) Cisplatin Ineligible MIBC (EU, JPN) Ovarian (JPN)

KEYTRUDA QLEX (MK-3475A)

Breast (U.S.)

Cisplatin Eligible MIBC (U.S.)

WELIREG (MK-6482)

Clear Cell RCC Following Nephrectomy (U.S.) 1,5

Previously Treated Advanced RCC (U.S., JPN) 1

Cardiometabolic & Respiratory

MK-0616 (enlicitide decanoate)

Primary Hypercholesterolaemia or Mixed Dyslipidaemia (EU)

WINREVAIR (MK-7962)

Pulmonary arterial hypertension (U.S.)

Infectious Diseases

ENFLONSIA (MK-1654)

Respiratory Syncytial Virus (JPN)

As of April 30, 2026

Broad and innovative pipeline to address significant unmet medical needs

‌6MWD = 6-minute walk distance

AE = Adverse event

AHA/ACC = American Heart Association/American College of Cardiology

ASCVD = Atherosclerotic cardiovascular disease

BCR::ABL = Breakpoint Cluster Region - Abelson murine leukemia viral oncogene homolog

BLA = Biologics license application

CML = Chronic myeloid leukemia

CNPV = Commissioner's National Priority Voucher

CpcPH-HFpEF = Combined post- and pre-capillary pulmonary hypertension in heart failure with preserved ejection fraction

DME = Diabetic macular edema

EFS = Event free survival

HeFH = Heterozygous familial hypercholesterolemia

HIV-1 = Human Immunodeficiency Virus Type 1

I-DXd = Ifinatamab deruxtecan

JAK = Janus kinase

LDL-C = Low-density lipoprotein cholesterol

MAb = Monoclonal antibody

MIBC = Muscle invasive bladder cancer

NVAMD = Neovascular age-related macular degeneration

OS = Overall survival

PCD = Primary completion date

PCSK9i = Proprotein convertase subtilisin/kexin type 9 inhibitor

PD-1/PD-L1 = Programmed cell death protein-1/Programmed cell death ligand-1

PVR = Pulmonary vascular resistance

RCC = Renal cell carcinoma

RSV = Respiratory syncytial virus RVO = Retinal vein occlusion SAE = Serious adverse event SCLC = Small cell lung cancer

SSc-ILD = Systemic sclerosis associated interstitial lung disease

TIE-2 = Tyrosine kinase with immunoglobulin-like and EGF-like domains 2

TKI = Tyrosine kinase inhibitor TTCW = Time to clinical worsening UC = Ulcerative colitis

VEGF = Vascular endothelial growth factor

Acronyms

Disclaimer

Merck & Co. Inc. published this content on April 30, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 30, 2026 at 10:47 UTC.