Regeneron Pharmaceuticals, Inc. (REGN) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call summary highlighted strong growth prospects for key products like Dupixent and EYLEA HD, along with robust financial metrics such as $4.1 billion in free cash flow and $3.8 billion returned to shareholders. Despite some unclear responses in the Q&A, the pipeline expansion and optimistic guidance on new product developments suggest positive momentum. The company's strategic focus on innovative therapies and shareholder returns further supports a positive outlook for the stock price over the next two weeks.
Key Financial Performance
Total Revenue Fourth quarter total revenue was $3.9 billion, up 3% year-over-year. The increase was driven by higher collaboration revenue, strong global DUPIXENT sales growth, continued growth in net sales of EYLEA HD and LIBTAYO, and higher other revenue. However, this was partially offset by lower net sales of EYLEA 2 milligrams.
DUPIXENT Global Net Sales Global net sales for DUPIXENT were $4.9 billion in the fourth quarter, representing a 32% year-over-year increase. For the full year 2025, sales reached $17.8 billion. The growth was attributed to its approval in 8 indications and its position as the most widely used innovative branded antibody medicine.
LIBTAYO Global Net Sales Global net product sales for LIBTAYO were $425 million in the fourth quarter, up 13% year-over-year at constant exchange rates. For the full year 2025, sales were $1.45 billion. Growth was driven by its market-leading position in advanced non-melanoma skin cancers and its increasing share in advanced non-small cell lung cancer.
EYLEA HD Net Sales (U.S.) EYLEA HD net product sales in the United States were $506 million in the fourth quarter, up 66% year-over-year. For the full year 2025, sales were $1.6 billion, up 36%. Growth was supported by recent FDA approvals for macular edema following retinal vein occlusion and monthly dosing across all approved indications.
EYLEA 2mg Net Sales (U.S.) EYLEA 2 milligrams net sales in the U.S. declined 15% sequentially in the fourth quarter to $577 million. The decline was attributed to competition and ongoing conversion to EYLEA HD.
Sanofi Collaboration Revenue Fourth quarter total Sanofi collaboration revenues were approximately $1.6 billion, with Regeneron's share of profits growing 42% year-over-year. This growth was primarily driven by DUPIXENT and improving collaboration margins.
Bayer Collaboration Revenue Fourth quarter net sales of EYLEA and EYLEA 8 milligrams outside the U.S. were $817 million, including $312 million from EYLEA 8 milligrams. Total Bayer collaboration revenue was $319 million, with $270 million related to Regeneron's share of net profits outside the U.S.
Other Revenue Other revenue grew 33% in the fourth quarter to $239 million. This included $179 million related to royalty income from Ilaris, which achieved net sales exceeding $1.5 billion in 2025.
R&D Expense R&D expense was $1.3 billion in the fourth quarter, reflecting continued investments in Regeneron's innovative pipeline, including multiple late-stage opportunities.
SG&A Expense SG&A expense was $691 million in the fourth quarter, including a $60 million matching contribution to the Good Days' Vascular and Neovascular Retinal Disease Fund.
Free Cash Flow Regeneron generated $4.1 billion in free cash flow in 2025.
Shareholder Returns In 2025, Regeneron returned $3.8 billion to shareholders, primarily through $3.4 billion in share repurchases. Additionally, nearly $400 million was paid in cash dividends.
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Operating Highlights
DUPIXENT: Global net sales reached $4.9 billion in Q4 and $17.8 billion for the full year 2025. Approved in 8 indications, it is the most widely used innovative branded antibody medicine with over 1.4 million patients globally.
LIBTAYO: Global net sales were $425 million in Q4 and $1.45 billion for the full year 2025. It is the market-leading immunotherapy for advanced non-melanoma skin cancers and has shown growth in advanced non-small cell lung cancer.
EYLEA HD: Net product sales in the U.S. were $506 million in Q4, up 66%, and $1.6 billion for the full year 2025. Recent FDA approval for macular edema following retinal vein occlusion and monthly dosing across all indications strengthens its profile.
LYNOZYFIC: Launched for relapsed/refractory multiple myeloma with a differentiated clinical profile, less burdensome hospitalization requirements, and convenient dosing regimen.
Geographic Expansion: DUPIXENT is approved in 8 indications globally, with significant under-penetration in most markets, indicating room for growth.
LIBTAYO Expansion: LIBTAYO is gaining market share in advanced non-small cell lung cancer in the U.S., now the second most prescribed immunotherapy in the first-line setting.
FDA Approvals: Anticipates at least 4 FDA approvals in 2026, including 3 for new molecular entities and EYLEA HD prefilled syringe.
Clinical Trials: Plans to initiate 18 additional Phase III studies in 2026, targeting enrollment of approximately 35,000 patients.
Manufacturing Enhancements: Investments in expanding bulk manufacturing capacity and fill/finish capabilities to support growing portfolio.
Cost Reduction Negotiations: Engaging with U.S. government to reduce drug costs while ensuring access to medical advancements and maintaining U.S. leadership in biotechnology.
Capital Deployment: Continues share repurchases, dividends, and complementary business development to drive long-term shareholder value.
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Risk or Challenges
EYLEA HD and EYLEA 2mg: EYLEA 2mg is facing competitive pressure, which is expected to intensify in the second half of 2026 due to the launch of multiple biosimilar products in the U.S. This could impact revenue and market share.
Patient affordability issues: Continued patient co-pay affordability issues have dampened growth in the branded anti-VEGF category, potentially limiting access and sales.
Regulatory and manufacturing challenges: The FDA's pre-licensing inspection for EYLEA HD prefilled syringe and Catalent's efforts to resolve previous inspection findings pose risks to timely product approval and launch.
Drug cost negotiations with U.S. government: Ongoing negotiations with the U.S. government to reduce drug costs could impact pricing and profitability, depending on the outcome.
Late-stage pipeline expansion: The company plans to initiate 18 additional Phase III studies in 2026, which could strain resources and increase R&D expenses, potentially impacting financial performance if outcomes are delayed or unsuccessful.
LIBTAYO competition: LIBTAYO faces competition in the advanced non-small cell lung cancer market, which could affect its market share and growth.
Obesity program differentiation: The obesity program, including olatorepatide and its combination with PRALUENT, faces challenges in differentiating itself in a competitive market.
Economic uncertainties: General economic uncertainties could impact patient access, pricing, and overall market conditions, affecting revenue and growth.
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Guidance & Outlook
LIBTAYO growth: LIBTAYO is expected to be a significant growth driver in 2026 and beyond, particularly with its new indication for adjuvant CSCC.
EYLEA HD growth: EYLEA HD is anticipated to continue growing in 2026, supported by recent FDA approvals for macular edema following RVO and monthly dosing. However, EYLEA 2 milligrams will face intensified competitive pressure in the second half of 2026 due to biosimilar launches.
FDA approvals and regulatory submissions: Regeneron anticipates at least 4 FDA approvals in 2026, including 3 for new molecular entities and one for the EYLEA HD prefilled syringe. Several additional regulatory submissions are also expected.
Clinical development and trials: Regeneron plans to initiate 18 additional Phase III studies in 2026, targeting approximately 35,000 patients over multiple years. This includes pivotal studies in areas such as myeloma, anticoagulation, and complement-mediated diseases.
New product development: The company plans to begin clinical development of at least 3 first-in-class antibodies addressing novel targets, including a long-acting IL-13 antibody for atopic dermatitis.
Commercial execution: Regeneron expects strong commercial execution to maximize the potential of its leading brands across key therapeutic areas.
Capital deployment: The company plans to continue share repurchases, dividends, and complementary business development to drive long-term shareholder value.
Pipeline advancements: Regeneron aims to advance its pipeline in areas such as oncology, hematology, complement-mediated diseases, anticoagulation, and obesity, with multiple pivotal readouts and regulatory milestones expected in 2026.
Obesity program: The company is pursuing a differentiated strategy in obesity, including pivotal monotherapy studies for olatorepatide in 2026 and a co-formulation with PRALUENT for combined weight loss and LDL cholesterol reduction.
Rare diseases: Regeneron is awaiting regulatory decisions for DB-OTO gene therapy and garetosmab for fibrodysplasia ossificans progressiva in 2026.
Financial guidance: 2026 R&D spend is expected to be $5.9 billion to $6.1 billion, SG&A spend $2.5 billion to $2.65 billion, gross margin on net product sales 83%-84%, capital expenditures $1.1 billion to $1.3 billion, and effective tax rate 13%-15%.
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Shareholder Return Plan
Quarterly Dividend: The Board of Directors authorized a quarterly dividend of $0.94 per share payable in March, equivalent to $3.76 on an annual basis.
Dividend Initiation: In 2025, Regeneron initiated a quarterly dividend, paying nearly $400 million in cash dividends.
Dividend Purpose: The dividend is aimed at expanding the pool of potential shareholders to include funds with a dividend mandate.
Share Repurchase Program: Regeneron returned $3.4 billion to shareholders in 2025 through share repurchases.
Remaining Authorization: As of December 31, $1.5 billion remains authorized for share repurchases.
Capital Deployment Strategy: Share repurchases remain the primary means of returning capital to shareholders, complemented by dividends.
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Key Q&A
Q:When can we expect data readouts for LIBTAYO plus fianlimab in metastatic melanoma and adjuvant?
A:The timing for the advanced melanoma readout is estimated to be in the first half of the year. The adjuvant timing is also in the first half, and the two may or may not coincide. Data will be read out shortly after it is available.
Q:What is the company's response to Sanofi's commentary on extending DUPIXENT IP runway?
A:The company did not provide additional comments on Sanofi's commentary but highlighted follow-on opportunities in the space, including long-acting IL-13, IL-4, and IL-4/IL-13 bispecifics, as well as a new version of DUPIXENT with potentially improved properties.
Q:What is the bar for hazard ratio in the frontline metastatic melanoma data, and what about PD-L1 expression levels?
A:The study is powered to achieve an effect on the primary endpoint (PFS) analogous to the current combination standard of care, with hopes for better results. PD-L1 expression levels are not used as inclusion or exclusion criteria, and the population represents a true first-line advanced melanoma population.
Q:Will the company focus more on I&I, ophthalmology, and oncology compared to other therapeutic areas?
A:The company takes an agnostic approach guided by genetics and focuses on innovative approaches across all therapeutic areas. While I&I, ophthalmology, and oncology are significant, the company remains committed to balanced efforts across all six areas.
Q:What is the status and potential of the 'souped-up' version of DUPIXENT?
A:The new version of DUPIXENT may be longer-acting and have other advantages. It is moving forward in clinical trials and is covered under the alliance with Sanofi.
Q:What differentiates the company's geographic atrophy (GA) program from existing therapies?
A:The program explores both systemic and local blockade, aiming for better efficacy and safety. Systemic approaches may avoid risks like retinal vasculitis and address bilateral disease more effectively. The primary endpoint is growth rate in GA lesion area, with a secondary endpoint measuring visual acuity.
Q:What are the growth trends and impact of the prefilled syringe for EYLEA HD?
A:EYLEA HD is making good progress, and the prefilled syringe, if approved, will enhance convenience for offices and potentially increase usage.
Q:What is the company's approach to the PCSK9 and GIP/GLP combo?
A:The company has developed a formulation that combines both drugs in a single auto-injector. This combination offers weight loss benefits along with significant LDL cholesterol reduction, addressing both obesity and cardiovascular risk.
Q:What is the company's perspective on Bayer's oral Factor XI inhibitor data and its relevance to their Factor XI antibody program?
A:The company believes their antibody offers better specificity and efficacy compared to small molecules, potentially providing better anticoagulation with less bleeding risk. The antibody may allow for occasional shots rather than continuous medication.
Q:What gives the company confidence in moving their GLP-1/GIP into Phase III trials, and how is it differentiated?
A:The GLP-1/GIP has shown tirzepatide-like efficacy and safety in China and is in advanced Phase III trials there. The differentiation lies in combining it with a PCSK9 inhibitor, offering both weight loss and significant LDL cholesterol reduction, addressing broader health benefits.
Q:Review of Unclear Management Responses
A:Management avoided providing direct answers or lacked clarity on the timing of LIBTAYO plus fianlimab data readouts, the specifics of Sanofi's DUPIXENT IP commentary, and potential partnerships for the PCSK9 and GIP/GLP combo development.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
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DUPIXENT LIBTAYO
DUPIXENT sale
Disease Fund
EYLEA milligram
HD DUPIXENT
HD profile
III study
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JPMorgan conference
LIBTAYO CSCC
LIBTAYO sale
LIBTAYO treatment
LYNOZYFIC treatment
PNH
Phase III
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Regeneron
allergy
area
birch
cat
cell lung
cemdisiran
class profile
clinic
complement disease
development plan
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ophthalmology
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REGN Transcript
Regeneron Pharmaceuticals, Inc. (REGN) Q4 2025 Earnings Call Transcript
Positive1-30
The earnings call summary highlighted strong growth prospects for key products like Dupixent and EYLEA HD, along with robust financial metrics such as $4.1 billion in free cash flow and $3.8 billion returned to shareholders. Despite some unclear responses in the Q&A, the pipeline expansion and optimistic guidance on new product developments suggest positive momentum. The company's strategic focus on innovative therapies and shareholder returns further supports a positive outlook for the stock price over the next two weeks.
Regeneron Pharmaceuticals, Inc. (REGN) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Neutral1-12
Regeneron Pharmaceuticals, Inc. (REGN) Presents at Citi Annual Global Healthcare Conference 2025 Transcript
Neutral12-3
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Neutral12-2
REGN Slides
REGN Report
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