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REGENERON PHARMACEUTICALS (REGN)

Earnings summaries and quarterly performance for REGENERON PHARMACEUTICALS.

Research analysts who have asked questions during REGENERON PHARMACEUTICALS earnings calls.

Brian Abrahams

RBC Capital Markets

7 questions for REGN

Also covers: ACAD, ATAI, BCRX +17 more

Salveen Richter

Goldman Sachs

7 questions for REGN

Also covers: ACAD, AGIO, ALLO +20 more

Tyler Van Buren

TD Cowen

7 questions for REGN

Also covers: ADVM, ALLO, ARQT +12 more

Akash Tewari

Jefferies

6 questions for REGN

Also covers: ALKS, APLS, ARGX +15 more

Carter L. Gould

Barclays

6 questions for REGN

Also covers: ABBV, ALEC, AMGN +7 more

Cory Kasimov

Evercore ISI

6 questions for REGN

Also covers: BBIO, BMRN, BNTX +5 more

Evan Seigerman

BMO Capital Markets

6 questions for REGN

Also covers: ABBV, AMGN, ARVN +15 more

Terence Flynn

Morgan Stanley

6 questions for REGN

Also covers: ABBV, AMGN, ARVN +17 more

Alexandria Hammond

Wolfe Research

5 questions for REGN

Also covers: ABBV, AMGN, BMRN +6 more

Christopher Schott

JPMorgan Chase & Co.

5 questions for REGN

Also covers: ABBV, AMGN, AMRX +15 more

David Risinger

Leerink Partners

5 questions for REGN

Also covers: ABBV, AMGN, BMY +9 more

Christopher Raymond

Piper Sandler

3 questions for REGN

Also covers: ABBV, AGIO, AMGN +7 more

William Pickering

Sanford C. Bernstein & Co.

3 questions for REGN

Also covers: ALLO, ARWR, NTLA +1 more

Geoff Meacham

Citigroup Inc.

2 questions for REGN

Also covers: ABBV, AMGN, BMY +8 more

Jeffrey Meacham

Citi

2 questions for REGN

Mohit Bansal

Wells Fargo & Company

2 questions for REGN

Also covers: ABBV, AMGN, BMRN +16 more

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

Also covers: ABBV, AMLX, BIIB +4 more

Alice Natelton

Bank of America

1 question for REGN

Chris

Morgan Stanley

1 question for REGN

Also covers: GILD, MRNA, VRTX

Trung Huynh

UBS Group AG

1 question for REGN

Also covers: ABBV, ABOS, AMGN +5 more

Recent press releases and 8-K filings for REGN.

Regeneron details manufacturing expansion and pipeline updates
REGN
New Projects/Investments
Product Launch
  • 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.
4 days ago
Regeneron discusses FY 2025 strategy and pipeline at Citi Global Healthcare Conference
REGN
New Projects/Investments
Product Launch
M&A
  • 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.
4 days ago
Regeneron outlines manufacturing, commercial, and pipeline strategy at Citi Healthcare Conference
REGN
New Projects/Investments
M&A
Product Launch
  • 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.
4 days ago
Regeneron details 2025 product performance and 2026 outlook at HealthCONx
REGN
  • 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%.
5 days ago
Regeneron highlights 2025 portfolio expansions and $4 billion capital return plan
REGN
Dividends
Share Buyback
New Projects/Investments
  • 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.
5 days ago
Regeneron obtains EU approval for Dupixent in chronic spontaneous urticaria
REGN
Product Launch
  • 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.
Nov 25, 2025, 6:09 AM
Regeneron approves EYLEA HD for retinal vein occlusion
REGN
Product Launch
  • 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.
Nov 20, 2025, 2:03 AM
Regeneron highlights Eylea HD growth drivers and pipeline at Jefferies London Healthcare Conference
REGN
Revenue Acceleration/Inflection
New Projects/Investments
  • 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.
Nov 17, 2025, 3:30 PM
Regeneron outlines Eylea HD growth, patient funding program, and pipeline at Jefferies London Healthcare Conference 2025
REGN
New Projects/Investments
Share Buyback
M&A
  • 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.
Nov 17, 2025, 3:30 PM
Regeneron outlines melanoma trial readout, CSCC and pipeline updates
REGN
Product Launch
New Projects/Investments
  • 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.
Nov 17, 2025, 2:20 PM