Merck & Co., Inc. (MRK) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call summary indicates strong financial performance with a positive EPS, growth in key product areas, and a robust pipeline. The Q&A section shows confidence in future growth and product potential, despite some unclear responses. The company's guidance and strategic investments in R&D and manufacturing also suggest optimism. The overall sentiment leans positive, although the lack of clarity on some issues slightly tempers the enthusiasm.
Key Financial Performance
Total company revenues $16.4 billion, an increase of 5% or 4% excluding the impact of foreign exchange. Growth driven by oncology, Animal Health, and new product launches.
KEYTRUDA family of products sales $8.4 billion, increased by 5%. Growth driven by uptake in earlier-stage cancers and strong demand for metastatic indications. U.S. growth negatively impacted by $200 million due to timing of purchases.
WELIREG sales $220 million, increased by 37%. Growth driven by increased use in advanced renal cell carcinoma in the U.S. and international market uptake.
GARDASIL sales $1 billion, decreased by 35%. Decline driven by lower demand in China and Japan, partially offset by 8% growth in other international markets and 7% growth in the U.S. due to price.
CAPVAXIVE sales $279 million. Growth driven by demand from retail pharmacies and non-retail customers, including seasonal immunization activity in the U.S.
ENFLONSIA sales $21 million. Initial uptake constrained by lower-than-expected infant immunization rates and high levels of RSV monoclonal antibody inventory in the market.
WINREVAIR sales $467 million. Growth driven by strong demand for pulmonary arterial hypertension treatment, with over 1,500 new U.S. patients and international market progress.
OHTUVAYRE sales $178 million. Reflects revenues post-acquisition of Verona. Growth driven by new patient starts, increased prescribing physicians, and total patients treated.
Animal Health sales Increased by 6%. Livestock sales grew 9% due to higher demand across all species. Companion animal sales were flat due to reduced vet visits.
Gross margin 79.7%, decreased by 1.1 percentage points. Decline due to higher inventory reserves, partially offset by favorable product mix.
Operating expenses $6.8 billion. Decrease attributed to lower business development charges compared to the previous year, offset by increased investment in pipeline and growth drivers.
Earnings per share (EPS) $2.04. Reflects overall financial performance.
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Operating Highlights
New Product Launches: Successful launches in cardiometabolic, respiratory, and vaccines, including KEYTRUDA QLEX, OHTUVAYRE for COPD, and CAPVAXIVE for pneumococcal immunization.
Pipeline Advancements: Progress in over 20 potential new growth drivers, including enlicitide (oral PCSK9 inhibitor), WINREVAIR (pulmonary hypertension), and islatravir (HIV treatment).
Acquisitions: Acquired Verona Pharma and Cidara Therapeutics, expanding respiratory and infectious disease portfolios.
Market Expansion: Expanded presence in oncology, cardiometabolic, respiratory, and vaccines markets globally. Strong growth in Animal Health and new approvals in Europe for WINREVAIR.
Revenue Growth: 2025 revenues reached $16.4 billion in Q4, driven by oncology, new product launches, and Animal Health.
Operational Efficiency: Flat operating expenses despite increased investments in pipeline and product launches. Multiyear optimization initiatives contributed to cost management.
Revenue Management: KEYTRUDA family sales grew 5% to $8.4 billion, with strong demand in oncology and combination therapies.
Strategic Shifts: Focused on transforming the portfolio with over $70 billion in potential commercial opportunities by mid-2030s. Investments in new launches and pipeline advancements to sustain long-term growth.
Business Development: Prioritized acquisitions and partnerships, including Verona Pharma and Cidara Therapeutics, to enhance pipeline and market positioning.
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Risk or Challenges
Regulatory and Legal Risks: The company highlighted significant risks and uncertainties related to forward-looking statements, which are subject to regulatory and legal challenges. This includes risks identified in SEC filings and the potential for material differences in actual results.
Market and Competitive Pressures: The company faces competitive pressures in oncology, cardiometabolic, and respiratory markets. Additionally, there is a headwind of approximately $2.5 billion from generic competition, IRA price setting, and restructured agreements for certain products.
Supply Chain and Operational Challenges: Initial uptake of ENFLONSIA has been constrained by lower-than-expected infant immunization rates and high levels of RSV monoclonal antibody inventory in the market. This indicates potential supply chain and operational inefficiencies.
Economic and Financial Risks: The company expects significantly lower sales of LAGEVRIO due to continued soft demand. Additionally, there are financial risks associated with the $9 billion one-time charge for the acquisition of Cidara and ongoing costs to advance MK-1406.
Strategic Execution Risks: The company is making substantial investments in new product launches and pipeline development, which carry inherent risks of execution and return on investment. There is also a reliance on achieving clinical milestones and regulatory approvals for future growth.
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Guidance & Outlook
Revenue Expectations: Merck expects revenue for 2026 to be between $65.5 billion and $67 billion, representing growth of 1% to 3%, including a positive impact from foreign exchange of approximately 1 percentage point.
Gross Margin: The gross margin assumption for 2026 is approximately 82%.
Operating Expenses: Operating expenses are assumed to be between $35.9 billion and $36.9 billion, which includes a one-time charge of approximately $9 billion related to the acquisition of Cidara.
Earnings Per Share (EPS): Merck expects EPS of $5 to $5.15 with a midpoint of $5.08, including a positive impact from foreign exchange of approximately $0.10.
Animal Health Business: Strong growth is expected in the Animal Health business, contributing to long-term outlook.
Pipeline and Product Launches: Merck anticipates significant contributions from new product launches and a robust pipeline, including over 20 potential new growth drivers. Ten of these programs could be substantially clinically derisked over the next 2 years, representing the majority of $70 billion of non-risk-adjusted commercial opportunity by the mid-2030s.
Keytruda and Oncology Portfolio: Continued strength in oncology, including Keytruda, is expected to drive growth despite headwinds from generic competition and IRA price setting.
HIV Treatment: Phase III data for islatravir combined with lenacapavir, potentially the first once-weekly oral treatment regimen for people living with HIV, is expected in 2026.
Cardiometabolic and Respiratory Pipeline: Phase III data readouts for enlicitide, a potential new oral PCSK9 inhibitor, and other cardiometabolic and respiratory candidates are expected in 2026.
Ophthalmology Pipeline: Phase III data for MK-3000, a novel Wnt agonist for diabetic macular edema, is expected in 2026.
Influenza Prevention: MK-1406, a potentially first-in-class long-acting antiviral candidate for influenza prevention, has greater than $5 billion in revenue potential and is expected to be a meaningful growth driver later this decade.
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Shareholder Return Plan
Dividend Commitment: The company remains committed to the dividend with the goal of increasing it over time.
Share Repurchase Program: The company assumes approximately $3 billion of share repurchases in 2026.
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Key Q&A
Q:Can you elaborate on the CD388 asset and the potential for interim results in the ANCHOR trial?
A:Dean Li explained that the trial is event-driven and emphasized the importance of having robust data across subpopulations for future labeling. Enrollment in the Northern Hemisphere is complete, and recruitment is ongoing in the Southern Hemisphere. Communication plans following the interim analysis have not been disclosed yet.
Q:Are there plans to explore sac-TMT in a first-line NSCLC setting or head-to-head against the KEYNOTE-189 regimen?
A:Dean Li stated that sac-TMT is considered a workhorse ADC with potential to be best-in-class. He highlighted the 16 Phase III studies underway, with 11 being first-in-class and 5 differentiated. He challenged the notion that the program is conservative, emphasizing its robust and ambitious nature.
Q:How should we model the IP run rate for KEYTRUDA and the timing of QLEX's ramp prior to KEYTRUDA's IV biosimilar introduction?
A:Robert Davis clarified that KEYTRUDA's compound patent expires in December 2028, with two additional patents extending to May and November 2029. For planning, 2028 is assumed as the conservative expiration date. QLEX adoption is expected to reach 30%-40% by 2028, with pricing strategies aimed at driving adoption.
Q:Can you contextualize the importance of a dual regimen versus the standard of care in HIV treatment?
A:Dean Li highlighted the potential of islatravir as a next-generation nucleoside analog with high potency and resistance. He emphasized the importance of offering a two-drug regimen without an INSTI backbone for metabolic and long-term issues. He also mentioned the development of weekly and monthly oral options.
Q:What is Merck's growth outlook given recent challenges and future opportunities?
A:Robert Davis expressed confidence in Merck's ability to achieve sustainable growth, citing a $70 billion potential pipeline. He emphasized the broad pipeline, early-stage assets, and business development as drivers of growth. He also noted that the company expects to derisk most of the portfolio by 2027.
Q:What should we expect from the CADENCE Phase II data and potential endpoints for Phase III?
A:Dean Li stated that the Phase II data will include primary and secondary endpoints. Discussions with the FDA are ongoing to define outcomes and endpoints for the Phase III trial, focusing on functional activity, clinical events, and biomarkers for an orphan indication population.
Q:How does Merck view the importance of pursuing combinations in the TL1A program?
A:Dean Li emphasized the ambition to be first and best-in-class in TL1A. He acknowledged the potential for combinations, bispecifics, and orals in the future but refrained from providing specific details on a public call.
Q:Can you provide updates on WINREVAIR's market performance and potential future indications?
A:Dean Li and Robert Davis highlighted WINREVAIR's differentiation in PAH treatment, with over 110,000 prescriptions and 9,100 patients. They noted its potential in reshaping standard care and exploring related pulmonary indications, including pulmonary hypertension and connective tissue disorders.
Q:What gives Merck confidence in MK-3000, and how large is the opportunity?
A:Dean Li and Robert Davis emphasized MK-3000's novel mechanism targeting vascular stability in the eye, addressing unmet needs in DME and wet AMD. They highlighted the $15 billion market potential and the opportunity to treat patients unresponsive to VEGF therapies.
Q:What is Merck's biomarker strategy for sac-TMT in light of competitor developments?
A:Dean Li stated that the biomarker strategy depends on the tumor type and the comparator's efficacy. He emphasized the importance of context in determining the need for biomarkers.
Q:Review of Unclear Management Responses
A:Management avoided providing direct answers or lacked clarity on the following: 1. Communication plans following the interim analysis for the CD388 asset. 2. Specific details on pursuing combinations in the TL1A program. 3. Detailed biomarker strategies for sac-TMT in specific tumor types.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
American
Animal Health
CD
CORALreef
Cidara
HIV
III result
III study
III trial
KEYNOTE
KEYTRUDA QLEX
MK
Phase II
Phase III
WINREVAIR
acquisition
adult
antibody
bladder cancer
candidate
cardiometabolic respiratory
cell
charge
cisplatin
disease
drug
inhibitor
oncology
patient
portfolio
product launch
program
rate
regimen
risk
treatment
value
MRK Transcript
Merck & Co., Inc. (MRK) Q4 2025 Earnings Call Transcript
Positive2-3
The earnings call summary indicates strong financial performance with a positive EPS, growth in key product areas, and a robust pipeline. The Q&A section shows confidence in future growth and product potential, despite some unclear responses. The company's guidance and strategic investments in R&D and manufacturing also suggest optimism. The overall sentiment leans positive, although the lack of clarity on some issues slightly tempers the enthusiasm.
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Frequently Asked Questions
Where does this earnings call transcript come from?
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