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Regeneron Pharmaceuticals, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 30 January 2026: press release. Guidance figures: 9 new. The quarter’s numbers.

Key takeaways

  • Revenue rose 3% in fourth quarter: The company reported fourth quarter revenue of $3.9 billion, up 3%, and full year revenue of $14.3 billion, up 1%. Net product sales fell 16% in the quarter, while collaboration revenue rose 23%. Source
  • Quarterly EPS fell on both bases: Fourth quarter GAAP diluted EPS was $7.86, down 2%, and non-GAAP diluted EPS was $11.44, down 5%. The quarter includes a $0.14 unfavorable impact from an acquired IPR&D charge. Source
  • Dupixent sales rose 26% for year: Sanofi recorded global Dupixent net sales of $4.9 billion in the fourth quarter, up 34%, and $17.8 billion for full year 2025. Regeneron books its share of profit as collaboration revenue. Source
  • EYLEA franchise sales fell 27% for year: Total EYLEA HD and EYLEA U.S. net sales fell 27% for full year 2025 to $4.4 billion. EYLEA HD U.S. rose 36% to $1.6 billion, while EYLEA U.S. fell 42% to $2.7 billion. Source
  • R&D spend rose 14% on pipeline: GAAP R&D rose 14% to $5.85 billion for full year 2025, and non-GAAP R&D rose 13% to $5.15 billion. Management attributed the increase to advancement of the late-stage pipeline. Source
  • EYLEA HD approved for RVO: The FDA approved EYLEA HD for retinal vein occlusion with up to every 8-week dosing after a monthly start. It also approved a monthly option across approved indications. Source
  • $2 billion Saratoga Springs plant planned: The company plans about $2 billion for a bulk manufacturing facility in Saratoga Springs, New York, expected to create 1,000 high-paying jobs, on top of more than $7 billion of domestic investment. Source

“Regeneron performed well in 2025, with financial strength driven by our four blockbuster medicines and future growth supported by our exciting late-stage clinical portfolio”

Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron

Guidance

AreaPeriodFigureAgainst last quarter
GAAP R&D Sourcefull year 2026$6.450 - $6.680 billion
Non-GAAP R&D Sourcefull year 2026$5.900 - $6.100 billionNew
GAAP SG&A Sourcefull year 2026$2.860 - $3.040 billionNew
Non-GAAP SG&A Sourcefull year 2026$2.500 - $2.650 billionNew
GAAP gross margin on net product sales Sourcefull year 202679% - 80%New
Non-GAAP gross margin on net product sales Sourcefull year 202683% - 84%New
Cost of collaboration and contract manufacturing (COCM) Sourcefull year 2026$940 million - $1.020 billionNew
Capital expenditures Sourcefull year 2026$1.100 - $1.300 billionNew
GAAP effective tax rate Sourcefull year 202612% - 14%New
Non-GAAP effective tax rate Sourcefull year 202613% - 15%New

What changed from last quarter

  • New guidance: Full year 2026 financial guidance was issued in this release. The January presentation had said formal guidance would follow Q4 2025 earnings. Source
  • New: The Tessera collaboration for TSRA-196 became effective in January 2026. Tessera will lead the first-in-human trial and Regeneron will lead later global development. Source
  • New: The company plans about $2 billion for a new bulk manufacturing facility in Saratoga Springs, New York, on top of previously announced domestic investment. Source
  • New: The company committed to matching Good Days donations of up to $200 million during 2026, after a matching program that ran quarterly through 2025. Source

Results and growth drivers

  • Revenue rose 3% in fourth quarter: The company reported fourth quarter revenue of $3.9 billion, up 3%, and full year revenue of $14.3 billion, up 1%. Net product sales fell 16% in the quarter, while collaboration revenue rose 23%. Source
  • Quarterly EPS fell on both bases: Fourth quarter GAAP diluted EPS was $7.86, down 2%, and non-GAAP diluted EPS was $11.44, down 5%. The quarter includes a $0.14 unfavorable impact from an acquired IPR&D charge. Source
  • Full-year non-GAAP EPS declined 3%: Full year non-GAAP diluted EPS was $44.31, down 3% from $45.62. Full year GAAP diluted EPS rose 8% to $41.48. Source
  • Free cash flow rose to $4.1 billion: Full year free cash flow was $4,080.5 million, up from $3,664.6 million. It followed operating cash flow of $4,978.9 million and capital expenditures of $898.4 million. Source
  • Securities gains lifted GAAP other income: GAAP other income included $946 million of net gains on marketable and other securities for full year 2025, against $118 million in 2024. Fourth quarter included $22 million of net losses. Source

Product sales by brand

  • Dupixent sales rose 26% for year: Sanofi recorded global Dupixent net sales of $4.9 billion in the fourth quarter, up 34%, and $17.8 billion for full year 2025. Regeneron books its share of profit as collaboration revenue. Source
  • EYLEA franchise sales fell 27% for year: Total EYLEA HD and EYLEA U.S. net sales fell 27% for full year 2025 to $4.4 billion. EYLEA HD U.S. rose 36% to $1.6 billion, while EYLEA U.S. fell 42% to $2.7 billion. Source
  • Libtayo global sales rose 19%: Libtayo global net product sales were $425 million in the fourth quarter, up 16%, and $1.45 billion for full year 2025, up 19%. U.S. Libtayo rose 14% in the quarter to $285 million. Source
  • Praluent U.S. sales grew 8%: Praluent U.S. net sales rose 8% to $262 million for full year 2025. Evkeeza U.S. sales rose 29% to $162 million, and Inmazeb U.S. sales fell 51% to $37 million. Source

“As we look ahead to 2026, our focus remains on prioritizing internal investments”

Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron

Collaboration and other revenue

  • Sanofi collaboration revenue rose 30%: Sanofi collaboration revenue was $5.9 billion for full year 2025, up 30%. The company's share of antibody profits rose to $5.2 billion, driven by higher Dupixent sales. Source
  • Bayer collaboration revenue declined 5%: Bayer collaboration revenue was $1.42 billion for full year 2025, down 5%, and $319 million in the fourth quarter, down 15%, on lower profit share from EYLEA sales outside the U.S. Source
  • Other revenue rose 37% on royalties: Other revenue was $703 million for full year 2025, up 37%. Royalties on Ilaris and share of profits from ARCALYST totaled $506 million, against $293 million a year earlier. Source

Costs, margins and pricing

  • R&D spend rose 14% on pipeline: GAAP R&D rose 14% to $5.85 billion for full year 2025, and non-GAAP R&D rose 13% to $5.15 billion. Management attributed the increase to advancement of the late-stage pipeline. Source
  • Priority review voucher added $155 million: Fourth quarter and full year GAAP R&D included $155 million for a previously purchased priority review voucher, which the company decided to use for a regulatory submission. Source
  • SG&A fell 9% on lower donations: GAAP SG&A fell 9% to $2.70 billion for full year 2025. Fourth quarter SG&A included about $60 million for matching donations to Good Days. Source
  • Product gross margin fell to 82%: GAAP gross margin on net product sales was 82% for full year 2025, down from 86%. Non-GAAP was 85%, down from 88%. Fourth quarter GAAP margin was 81%, against 84%. Source
  • Manufacturing partner cost rose 9%: Cost of collaboration and contract manufacturing rose 9% to $960 million for full year 2025. Fourth quarter cost was $266 million, up 11%. Source
  • GAAP tax rate rose to 13.9%: The GAAP effective tax rate was 19.1% in the fourth quarter and 13.9% for full year 2025, against 4.2% and 7.7% a year earlier. Source

“Dupixent received new approvals in Japan and Europe and is currently the most widely used innovative branded antibody medicine, with over 1.4 million active patients worldwide”

Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron

Pipeline and regulatory milestones

  • About 45 candidates in development: The company reported about 45 product candidates in clinical development, including several marketed products being tested in additional indications. Source
  • EYLEA HD approved for RVO: The FDA approved EYLEA HD for retinal vein occlusion with up to every 8-week dosing after a monthly start. It also approved a monthly option across approved indications. Source
  • Libtayo approved in adjuvant skin cancer: The FDA and EC approved Libtayo as adjuvant treatment for high-risk cutaneous squamous cell carcinoma in October and November 2025, beyond metastatic or locally advanced disease. Source
  • Dupixent AFRS Phase 3 results positive: The company and Sanofi reported positive Phase 3 results in allergic fungal rhinosinusitis in November 2025. Dupixent was approved in Japan for asthma in children aged 6 to 11 in December. Source
  • DB-OTO gene therapy submitted: A BLA for DB-OTO, an AAV-based gene therapy for otoferlin-related hearing loss in children, was submitted in December 2025. Garetosmab filings for FOP were also made in the U.S. and EU. Source
  • New EYLEA HD vial filler approved: In December 2025 the FDA approved a new manufacturer to fill EYLEA HD vials. A regulatory application adding a new manufacturer for pre-filled syringes was submitted in the same month. Source

Capital, cash and shareholder returns

  • Buybacks totaled $3.5 billion: The company repurchased shares for $671 million in the fourth quarter and $3.5 billion for full year 2025, recorded as treasury stock. Source
  • $1.5 billion repurchase capacity remains: As of December 31, 2025, $1.5 billion remained available under the company's share repurchase programs. Source
  • Quarterly dividend set at $0.94: In January 2026 the board declared a $0.94 per share cash dividend, payable March 5, 2026 to holders of record on February 20, 2026. The January presentation cited a $0.88 quarterly dividend started in 2025. Source
  • Cash and securities near $18.9 billion: Cash and marketable securities were $18,865.8 million at December 31, 2025, up from $17,912.6 million a year earlier. Source

Strategy, manufacturing and business development

  • $2 billion Saratoga Springs plant planned: The company plans about $2 billion for a bulk manufacturing facility in Saratoga Springs, New York, expected to create 1,000 high-paying jobs, on top of more than $7 billion of domestic investment. Source
  • Tessera alpha-1 collaboration effective: The Tessera collaboration for TSRA-196, a program for alpha-1 antitrypsin deficiency, became effective in January 2026. Tessera leads the first-in-human trial; Regeneron leads later development. Source
  • Good Days matching capped for 2026: The company committed to match donations to Good Days for up to $200 million during 2026, following a quarterly matching program launched in July 2025. Source
  • Hansoh license up-front payment: Full year 2025 acquired IPR&D included an $80 million up-front payment under the Hansoh license agreement. Full year 2024 included a $45 million milestone under the Sonoma Biotherapeutics collaboration. Source

2026 guidance basis

  • Guidance excludes unclosed deals: The 2026 guidance does not assume completion of any business development transaction not completed as of the release date. Source
  • Non-GAAP R&D excludes stock compensation: Non-GAAP guidance excludes stock-based compensation. For 2026 that adjustment is projected at $550 million to $580 million for R&D. Source

Coming up, as management said on 30 January 2026

  • Fianlimab melanoma Phase 3 results: Phase 3 results for fianlimab with Libtayo versus pembrolizumab in first-line melanoma are due in the first half of 2026. Source
  • Dupixent AFRS FDA decision: The FDA decision on the Dupixent sBLA for allergic fungal rhinosinusitis is due in February 2026. Source
  • DB-OTO FDA decision timing: The FDA decision on the DB-OTO gene therapy BLA is expected in the first half of 2026. Source
  • EYLEA HD syringe FDA decision: The FDA decision on the EYLEA HD pre-filled syringe, including the new manufacturer, is expected in the second quarter of 2026. Source
  • Garetosmab FOP decisions: The FDA decision on the garetosmab BLA and the EC decision on its MAA for FOP are expected in the second half of 2026. Source
  • Olatorepatide obesity Phase 3 start: The company plans to start a Phase 3 olatorepatide program in obesity, with and without type 2 diabetes, during 2026. Source
  • Factor XI Phase 3 studies to start: Additional Phase 3 studies for two Factor XI antibodies in anticoagulation are planned to start in the first half of 2026. Source
  • PNH Phase 3 readout timing: Phase 3 results for pozelimab with cemdisiran in PNH are expected in the fourth quarter of 2026 or first quarter of 2027. Source
  • Geographic atrophy interim results: Initial results from the lead-in cohort of a cemdisiran Phase 3 study in geographic atrophy are planned for the second half of 2026. Source

Figures management reported

FigureReported
Dupixent global net sales (recorded by Sanofi), full year 2025 Source$17.8 billion
EYLEA HD U.S. net sales, full year 2025 Source$1.6 billion
Total EYLEA HD and EYLEA U.S. net sales, full year 2025 Source$4.4 billion
Libtayo global net product sales, full year 2025 Source$1.45 billion
Praluent U.S. net product sales, full year 2025 Source$262 million
GAAP R&D expense, full year 2025 Source$5.85 billion
Product candidates in clinical development Sourceapproximately 45
Phase 3 readout: allergic fungal rhinosinusitis (Dupixent) Sourcepositive results, November 2025

Risks management discussed

  • Demand: Management cited continued competitive pressure on EYLEA, share lost to compounded bevacizumab over patient affordability limits, and a lower net selling price. Source
  • Operational: Gross margin fell partly due to ongoing investment in manufacturing operations and higher inventory write-offs and reserves. Source
  • Financial: Amortization of the Libtayo intangible asset lowered GAAP gross margin on net product sales. Source
  • Operational: Year-end wholesaler stock added about $30 million to each of EYLEA HD and EYLEA fourth quarter net sales. Source
  • Financial: A stock-based compensation shortfall and fewer option exercises raised the tax expense for the period. Source

Earlier plans management reported on

  • On track: The January presentation described the gMG FDA submission as on track for the first quarter of 2026.
  • Not stated: The January presentation said formal guidance would be provided with Q4 2025 earnings. This release contains the 2026 guidance table.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.