Earnings summaries and quarterly performance for REGENERON PHARMACEUTICALS.
Executive leadership at REGENERON PHARMACEUTICALS.
Leonard Schleifer
President and Chief Executive Officer
Andrew Murphy
Executive Vice President, Research
Christopher Fenimore
Executive Vice President, Finance and Chief Financial Officer
Daniel Van Plew
Executive Vice President and General Manager, Industrial Operations and Product Supply
George Yancopoulos
President and Chief Scientific Officer
Jason Pitofsky
Vice President, Controller
Joseph LaRosa
Executive Vice President, General Counsel and Secretary
Marion McCourt
Executive Vice President, Commercial
Board of directors at REGENERON PHARMACEUTICALS.
Arthur Ryan
Director
Bonnie Bassler
Director
Christine Poon
Lead Independent Director
Craig Thompson
Director
David Schenkein
Director
George Sing
Director
Huda Zoghbi
Director
Joseph Goldstein
Director
Kathryn Guarini
Director
Michael Brown
Director
N. Anthony Coles
Director
Research analysts who have asked questions during REGENERON PHARMACEUTICALS earnings calls.
Brian Abrahams
RBC Capital Markets
7 questions for REGN
Salveen Richter
Goldman Sachs
7 questions for REGN
Tyler Van Buren
TD Cowen
7 questions for REGN
Akash Tewari
Jefferies
6 questions for REGN
Carter L. Gould
Barclays
6 questions for REGN
Cory Kasimov
Evercore ISI
6 questions for REGN
Evan Seigerman
BMO Capital Markets
6 questions for REGN
Terence Flynn
Morgan Stanley
6 questions for REGN
Alexandria Hammond
Wolfe Research
5 questions for REGN
Christopher Schott
JPMorgan Chase & Co.
5 questions for REGN
David Risinger
Leerink Partners
5 questions for REGN
Christopher Raymond
Piper Sandler
3 questions for REGN
William Pickering
Sanford C. Bernstein & Co.
3 questions for REGN
Geoff Meacham
Citigroup Inc.
2 questions for REGN
Jeffrey Meacham
Citi
2 questions for REGN
Mohit Bansal
Wells Fargo & Company
2 questions for REGN
Simon Goodwin
Rothschild & Co. Redburn
2 questions for REGN
Taylor Hanley
JPMorgan Chase & Co.
2 questions for REGN
Tim Anderson
Bank of America
2 questions for REGN
Alice Natelton
Bank of America
1 question for REGN
Chris
Morgan Stanley
1 question for REGN
Trung Huynh
UBS Group AG
1 question for REGN
Recent press releases and 8-K filings for REGN.
- Leveraged $7 billion domestic manufacturing and R&D investment commitment in 2025, partnering with FUJIFILM Diosynth to expand capacities in Tarrytown and Saratoga, NY, while in active MFN drug‐pricing negotiations with the administration.
- Prioritized internal R&D and selective external collaborations, exemplified by the Tessera contract announced in early December, and remains open to strategic M&A for late‐stage assets.
- Eylea HD received FDA approvals for RVO and four-week dosing ahead of the 2026 commercial inflection, with a prefilled syringe NDA submission in Q1 2026 and anticipated Q2 2026 approval.
- Dupixent continues robust growth in atopic dermatitis (20–25% biologic penetration vs. ~40% in psoriasis), leads new-to-brand share in asthma, and has launched in COPD with highest new-to-brand share and superior exacerbation reduction; CSU and BP indications drive further market expansion.
- Late-stage pipeline milestones include the Phase III fianlimab+Libtayo melanoma PFS readout in H1 2026 , Linvoseltamab’s BCMA bispecific with ~70% ORR in rrMM and favorable CRS profile , and obesity programs on a Hansoh GIP/GLP-1 backbone with myostatin combo data expected in 2026.
- Regeneron announced a $7 billion commitment to expand U.S. R&D and manufacturing, including new facilities in New York and a contract manufacturing arrangement with FUJIFILM Diosynth Biotechnologies.
- The company remains open to M&A and external collaborations, but prioritizes internal investment and evaluates opportunities based on scientific and commercial potential.
- Recent Eylea HD label enhancements (RVO and Q4 dosing) were approved, with commercial impact expected to begin in 2026; a prefilled syringe submission is planned for Q2 2026.
- Dupixent continues robust growth, now treating over 1.3 million patients globally, with significant runway in atopic dermatitis and strong momentum in asthma and COPD indications.
- Regeneron highlighted promising pipeline assets, including fianlimab plus Libtayo in melanoma (phase 3 data expected H1 2026) and Linvoseltamab in myeloma, with best-in-class efficacy and safety data.
- Regeneron commits $7 billion to U.S. R&D and domestic manufacturing expansions, including partnerships with FUJIFILM Diosynth and new facilities in Tarrytown and Saratoga, NY.
- Capital allocation will prioritize internal R&D, with an active BD group open to M&A or collaborations for late-stage assets despite high valuations.
- Eylea HD enhancements (Q4 dosing and RVO approval) launched late 2025 with 2026 inflection expected; prefilled syringe submission planned for Q2 2026.
- Dupixent treats 1.3 million patients globally, benefits from underpenetrated AD (20–25% biologic uptake) and a strong COPD launch (30–35% exacerbation reduction).
- Pipeline updates include LAG-3/Libtayo combo Phase 3 melanoma PFS readout in H1 2026 and Phase 2 lung cancer results H1 2026, plus advancing bispecific oncology and obesity combination programs.
- Regeneron returned ~$4 billion to shareholders in 2025 via dividends and share repurchases and committed >$7 billion to U.S. manufacturing and R&D investment.
- EYLEA HD secured label enhancements (weekly dosing and RVO indication, ~17–18% of the market) with a prefilled syringe submission planned for Jan 2026 and expected approval by Q2 2026, with uptake accelerating in 2026.
- Dupixent expanded to eight indications, including COPD (~300k eligible patients), chronic spontaneous urticaria (~300k) and bullous pemphigoid (~27k), sustaining its trajectory toward $20 billion in sales.
- Pipeline milestones include positive Phase 3 data for Cemdisiran in generalized myasthenia gravis, U.S. and EU approvals of Linvoseltamab, EU approval of Ordspono, DB-OTO gene therapy successes and garetosmab in FOP reducing lesions by 99%.
- Expanded key products: Eylea HD secured weekly dosing and RVO label enhancements; Dupixent now covers 8 indications including COPD, CSU and bullous pemphigoid; Libtayo launched in adjuvant CSCC; Linvoseltamab approved in the US and Europe for relapsed/refractory multiple myeloma.
- Advanced pipeline: positive phase 3 results for Cemdisiran in generalized myasthenia gravis; DB-OTO gene therapy restoring hearing; garetosmab achieved 99% reduction in FOP lesion formation; Odronextimab approved in Europe; birch and cat allergy programs progressing to phase 3.
- Capital allocation: initiated a dividend and increased share repurchases by ~$1 billion (from $2.6 billion in 2024), targeting ~$4 billion in total shareholder returns in 2025.
- US investments: committed >$7 billion to expand domestic manufacturing and R&D infrastructure.
- The European Commission approved Dupixent (dupilumab) for moderate-to-severe chronic spontaneous urticaria in patients aged 12+ who are antihistamine-refractory and naïve to anti-IgE therapy, marking the first targeted CSU therapy in Europe in over a decade.
- The approval expands Dupixent’s label to seven chronic inflammatory diseases within the EU, broadening its market opportunity.
- Decision based on Phase 3 trials showing significant reductions in itch and hives at 24 weeks versus placebo.
- Regeneron and Sanofi continue global marketing of Dupixent, which achieved over $14 billion in net sales last year.
- The FDA approved EYLEA HD (aflibercept) 8 mg for macular edema following retinal vein occlusion, with dosing every eight weeks after an initial monthly phase and an alternative monthly option.
- Approval is based on Phase 3 QUASAR trial data showing non-inferior visual acuity gains with eight-week dosing compared to standard EYLEA 2 mg.
- The flexible regimen may halve the number of injections versus existing therapies and offers a monthly dosing option across all four EYLEA HD indications.
- Regeneron’s strong financials include a $73.86 billion market capitalization, 0.09 debt-to-equity ratio, 4.06 current ratio, and 90.44 interest coverage ratio.
- Regeneron’s Eylea HD unit demand grew 5% in Q1, 16% in Q2 and 18% in Q3, with Q4 expected to deliver high single-digit growth amid ongoing pricing pressure (~8% ASP headwind in Q3) and competitive dynamics, supported by four-week dosing, RVO label expansion and a 95% prefilled syringe preference.
- The company’s patient support strategy includes a dollar-for-dollar matching program (up to $200 million), but contributions to foundations were under $1 million in Q3; Regeneron remains committed to patient affordability and will define its 2026 approach later.
- Label enhancements for Eylea HD—RVO indication and Q4 dosing—face a November PDUFA likely leading to a CRL due to filler issues; a compliant filler resubmission is planned for late December, with prefilled syringe approval anticipated in H2 2026 after a January sBLA filing.
- Regeneron is investing $2 billion in a new New York manufacturing facility and expanding R&D in Tarrytown, while maintaining an active business development pipeline, share repurchase program and initiated dividend to deploy its strong cash flow.
- Pipeline updates include the Hanmi GLP-1 asset as a backbone for combination therapies, with phase 3 China readout in February and monotherapy potential; Myostatin maintenance data in H1 2026 and leptin add-on results next year; and two Factor XI antibodies targeting distinct domains, prioritizing venous clot and stroke prevention indications over ACS.
- Eylea HD unit demand accelerated sequentially with 5% in Q1, 16% in Q2, and 18% in Q3 growth; Q4 volumes are expected to moderate to high single digits amidst continued pricing pressure.
- Label enhancements for Q4 dosing and RVO face a late-November PDUFA likely yielding a CRL, with an alternative filler review in December and a prefilled syringe sBLA filing in January targeting H1 2026 approval.
- A mid-year patient assistance matching program (up to $200 million) has yielded under $1 million in Q3 contributions; Regeneron remains committed to supporting foundation funding and will finalize its 2026 strategy pending broader participation.
- Capital deployment includes a $2 billion manufacturing expansion in New York, ongoing share repurchases and dividend initiation, and selective M&A evaluated against high return thresholds.
- Pipeline priorities feature the in-licensed Hanmi GLP-1 as a backbone for combo therapies, Myostatin COURAGE maintenance readout in H1 2026, and dual Factor XI antibodies offering differentiated anticoagulation profiles for venous and AFib indications.
- Regeneron expects a Phase 3 melanoma PFS readout for fianlimab + cemiplimab by H1 2026, with the study powered to show benefit even if control PFS is in the mid-teens and an interim OS analysis planned.
- Adjuvant CSCC approval of Libtayo delivers a 68% reduction in recurrence risk and targets ~10,000 US patients, bolstering non-melanoma skin cancer leadership.
- Global Libtayo sales annualize at $1.2 billion, split ~60% non-melanoma skin cancer/40% lung; Linvoseltamab launch in relapsed multiple myeloma is progressing with 10 Phase III studies underway.
- Pipeline advances include an FC-silent LAG-3 antibody, bispecific co-stimulatory mAbs (e.g., CD28 bispecifics), anti-MUC16 CD3 in ovarian cancer, a MET-targeted ADC, and a PD-1-directed IL-2 in early clinical development.
Quarterly earnings call transcripts for REGENERON PHARMACEUTICALS.
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more