Regeneron Pharmaceuticals Q4 Earnings Call Highlights

Regeneron Pharmaceuticals (NASDAQ:REGN) closed out 2025 with what executives described as another “solid quarter of commercial execution,” highlighted by continued growth in Dupixent, Libtayo, and EYLEA HD, as well as a slate of upcoming regulatory and clinical catalysts. On the company’s fourth-quarter 2025 earnings call, management also reiterated its intent to pursue multiple late-stage readouts in 2026 and expand investment in a broad pipeline spanning ophthalmology, immunology, oncology, complement-mediated diseases, anticoagulation, and obesity.

Fourth-quarter results and product performance

Chief Executive Officer Leonard Schleifer said fourth-quarter total revenue increased 3% year over year, driven by “double-digit net sales growth for three of our leading products,” partially offset by lower sales of EYLEA 2 mg.

Key commercial highlights discussed on the call included:

• Dupixent: Global net sales reported by partner Sanofi increased 32% year over year at constant exchange rates to $4.9 billion in the fourth quarter, and $17.8 billion for full-year 2025. Schleifer said more than 1.4 million patients are on therapy globally, with Dupixent approved in eight indications that he described as “significantly underpenetrated.”
• Libtayo: Global net product sales rose 13% at constant exchange rates to $425 million in the fourth quarter and $1.45 billion for the full year. Schleifer and Commercial EVP Marion McCourt emphasized the recent FDA and European Commission approvals for adjuvant cutaneous squamous cell carcinoma (CSCC), which they expect to be a meaningful growth driver starting in 2026. McCourt added that Libtayo has been added to NCCN guidelines as the only Category One preferred immunotherapy in the adjuvant CSCC setting.
• EYLEA HD: U.S. net product sales were $506 million in the fourth quarter, up 66%, and $1.6 billion for 2025, up 36%. Management attributed momentum to demand growth and label enhancements, despite broader category headwinds tied to patient affordability issues.

McCourt said the EYLEA HD and EYLEA franchise delivered combined U.S. net sales of $1.1 billion in the fourth quarter, while noting EYLEA 2 mg U.S. net sales declined 15% sequentially to $577 million. She also cited new real-world data suggesting patients switching to EYLEA HD extended treatment duration by nearly four weeks on average.

EYLEA HD label expansion, prefilled syringe timeline, and affordability initiatives

Management highlighted several developments intended to “fully unlock EYLEA HD’s commercial potential.” Schleifer noted the FDA’s approval of EYLEA HD for macular edema following retinal vein occlusion (RVO) and for monthly dosing across all approved indications, and said supporting data will be presented at an upcoming Angiogenesis meeting.

Regeneron’s FDA submission for an EYLEA HD prefilled syringe using a new manufacturer has been accepted for review, with a standard pre-licensing inspection scheduled and a regulatory decision expected in late April, according to Schleifer. As a backup, he said Catalent’s Indiana site is working with the FDA to resolve findings from a prior inspection.

On affordability, Schleifer said the company matched a $60 million donation to the Good Days Retinal Vascular and Neovascular Disease Fund in the fourth quarter and extended a matching program through the end of 2026 up to $200 million. McCourt also cautioned that first-quarter 2026 results are typically affected by patient reauthorizations and that wholesaler inventory levels were elevated by about $30 million at the end of the fourth quarter for both EYLEA HD and EYLEA, which is expected to pressure first-quarter net sales as inventory is absorbed.

Schleifer also warned that while EYLEA HD is expected to continue growing, EYLEA 2 mg will remain under competitive pressure that management expects to intensify in the second half of 2026 as multiple U.S. biosimilars launch.

Pipeline and upcoming catalysts: melanoma, myeloma, complement, and more

Looking ahead, Schleifer said Regeneron anticipates at least four FDA approvals over the next 12 months, including three new molecular entities across three modalities, plus approval for the EYLEA HD prefilled syringe. He also said 2026 will be a major execution year, with plans to initiate 18 additional Phase III studies and a cumulative target enrollment of about 35,000 patients over multiple years.

Chief Scientific Officer George Yancopoulos detailed several programs management expects to drive near-term news flow:

• Fianlimab plus Libtayo in melanoma: The pivotal first-line metastatic melanoma study remains on track for a first-half readout. In Q&A, management said it did not have more specific timing and noted an interim analysis for adjuvant melanoma is also expected in the first half; the two may or may not coincide.
• Linvoseltamab in multiple myeloma: Yancopoulos said the BCMA x CD3 bispecific is showing strong activity across settings, citing results from a phase II study in newly diagnosed multiple myeloma where all nine evaluable patients on monotherapy at the planned Phase III dose achieved MRD negativity. He also described early signals in high-risk smoldering myeloma and light chain amyloidosis.
• C5 program (cemdisiran and pozelimab): In generalized myasthenia gravis, Yancopoulos said cemdisiran achieved a placebo-adjusted improvement of 2.3 points on the MG-ADL score at 24 weeks with every-three-month subcutaneous dosing, and the company remains on track to submit a U.S. application in the first quarter. In PNH, he said the cemdisiran and pozelimab strategy aims for best-in-class disease control, with pivotal data expected late 2026 or early 2027.
• Geographic atrophy: Interim phase III data for a GA program is expected in the second half of 2026. In Q&A, executives emphasized exploring both systemic and intravitreal approaches to address efficacy and safety concerns seen with current therapies, and said the initial pivotal study’s primary endpoint is GA lesion growth with a prospective secondary endpoint measuring 15-letter visual acuity loss.

Yancopoulos also described plans in immunology to develop long-acting antibodies targeting IL-4R? (the Dupixent target), IL-13, IL-4, and an IL-4/IL-13 bispecific, with a long-acting IL-13 antibody expected to enter the clinic in the coming months. Separately, he said a “souped-up” Dupixent-like molecule may offer longer acting properties and could advance with Sanofi under the alliance if developed further.

Financial highlights and 2026 guidance

Chief Financial Officer Christopher Fenimore said fourth-quarter 2025 total revenue was $3.9 billion. On a non-GAAP basis, diluted earnings per share were $11.44 on net income of $1.2 billion. He attributed growth to higher collaboration revenue tied to Dupixent, continued growth in EYLEA HD and Libtayo, and higher other revenue, offset by lower EYLEA 2 mg net sales.

Fenimore reported fourth-quarter Sanofi collaboration revenue of about $1.6 billion, including $1.5 billion related to Regeneron’s share of collaboration profits, which grew 42% year over year. He said the Sanofi development balance was just below $600 million at year-end and is now expected to be fully reimbursed by mid-2026.

For 2026, Fenimore reiterated guidance previously provided at the J.P. Morgan conference, including:

• R&D: $5.9 billion to $6.1 billion
• SG&A: $2.5 billion to $2.65 billion
• Gross margin on net product sales: 83% to 84%
• Capital expenditures: $1.1 billion to $1.3 billion
• Effective tax rate: 13% to 15%

The company also highlighted capital return actions, including $3.8 billion returned to shareholders in 2025 (primarily through share repurchases) and a newly authorized quarterly dividend of $0.94 per share payable in March.

About Regeneron Pharmaceuticals (NASDAQ:REGN)

Regeneron Pharmaceuticals, Inc (NASDAQ: REGN) is a U.S.-based biotechnology company founded in 1988 and headquartered in Tarrytown, New York. It focuses on discovering, developing, manufacturing and commercializing medicines for serious medical conditions. The company combines laboratory research, clinical development and in-house manufacturing to advance a pipeline of biologic therapies across multiple therapeutic areas.

Regeneron is known for its proprietary drug discovery technologies, including its VelocImmune platform, which is used to generate fully human monoclonal antibodies.