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.
- Regeneron highlighted the complex multiple myeloma treatment paradigm and its strategy to simplify care with linvoseltamab, now approved in the late-line setting and launched with over 300 REMS-certified institutions and 35 formulary wins.
- Phase II data for linvoseltamab + carfilzomib in second-line patients showed a 90% overall response rate and 76% complete response rate, with 87% of responses durable at 12 months.
- In newly diagnosed first-line multiple myeloma (LINKER-MM4), linvoseltamab monotherapy at 200 mg achieved an 86% overall response rate and 43% complete response rate at nine months, with all evaluable patients achieving MRD negativity at 10^-5 sensitivity.
- Early data in high-risk smoldering multiple myeloma (LINKER-SMM1) reported a 100% overall response rate and ~40% complete response rate at four months, leading to a pivotal LINKER-SMM2 study planned for H1 2026.
- Regeneron plans to initiate eight registrational studies across multiple myeloma lines and related conditions by mid-2026, with key readouts through 2029 to establish linvoseltamab as a BCMA bispecific backbone.
- Late-line LINKER-MM1 showed ORR 71%, CR 52%, and median DOR 29 months (median follow-up 20 months); received accelerated approval in July 2025 and confirmatory phase III LINKER-MM3 is fully enrolled (~410 pts; data expected 2027).
- Second-line Linvoseltamab + Carfilzomib achieved ORR 90%, CR 76%, with 87% of patients maintaining response at 12 months; phase III LINKER-MM5 will start in early 2026 (readout 2028).
- First-line monotherapy (LINKER-MM4) in newly diagnosed MM yielded ORR 86%, CR 43%, and MRD negativity in all nine evaluable patients at 200 mg (9 months follow-up); supports three phase III first-line trials to initiate in 2026.
- Precursor MM (high-risk SMM) saw ORR 100% and CR ~40% at <4 months follow-up; pivotal LINKER-SMM2 begins H1 2026; amyloidosis patients achieved normalization of involved free light chain in 15 days.
- In late-line relapsed/refractory multiple myeloma, linvoseltamab achieved 71% ORR and 52% CR at 20-month median follow-up, with median DOR of 29 months and time to response <1 month.
- The U.S. FDA granted accelerated approval in July 2025 for LINKER-MM1 trial data; confirmatory phase III LINKER-MM3 (≈410 patients) versus EloPd is fully enrolled, with results expected in 2027.
- Emerging first- and second-line data show 95% MRD negativity and rapid median time to PR (~1 month); safety remains manageable with only grade I CRS during step-up dosing.
- Eight registrational studies are underway or initiating by H1 2026 across front-line (LINKER-MM6/7/8), precursor conditions (LINKER-SMM1/2, MGUS), and amyloidosis (LINKER-AL2), with pivotal readouts through 2029.
- Commercial launch momentum includes >300 REMS-certified centers and addition to 35+ formularies; first- and second-line markets each represent >$10 billion opportunities.
- 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.
Quarterly earnings call transcripts for REGENERON PHARMACEUTICALS.
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