REGENERON PHARMACEUTICALS (REGN) Company Report

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.

2 days ago

Morningstar

Regeneron highlights Eylea HD growth drivers and pipeline at Jefferies London Healthcare Conference

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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.

5 days ago

Transcript

Regeneron outlines Eylea HD growth, patient funding program, and pipeline at Jefferies London Healthcare Conference 2025

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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.

5 days ago

Transcript

Regeneron outlines melanoma trial readout, CSCC and pipeline updates

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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.

5 days ago

Transcript

Regeneron outlines late-stage oncology pipeline and Libtayo expansion

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Phase III melanoma trial of fianlimab (anti-LAG-3) plus cemiplimab vs pembrolizumab includes two fianlimab doses (400 mg and 1,600 mg Q3W) and a cemiplimab calibrator arm to satisfy FDA Optimus dosing requirements; PFS is powered even if control arm PFS reaches mid-teens, with top-line readout by H1 2026.
Libtayo annual sales are running at ~$1.2 billion, with ~60% from non-melanoma skin cancer and the balance in lung cancer; adjuvant CSCC approval based on a 68% risk reduction in recurrence for ~10,000 U.S. patients, dosing options of 48 weeks Q3W or switching to Q6W after four doses.
In NSCLC, Libtayo holds an NCCN category 1 or co-preferred status, capturing ~15% new patient share in the U.S. and up to 25-40% in high-expressing cohorts, with notably strong squamous disease data.
The immuno-oncology pipeline includes pioneering co-stimulatory bispecifics (e.g., PSMA-CD28, MUC16-CD28), a MUC16-CD3 T-cell engager in platinum-resistant ovarian cancer, a PD-1–directed IL-2 fusion in dose escalation, and a novel MET-targeting ADC platform.
Linvoseltamab in relapsed/refractory multiple myeloma has launched successfully, supported by up to 10 ongoing Phase III studies aiming to establish it as a backbone therapy across earlier lines and precursor conditions.

5 days ago

Transcript

Regeneron presents hematology data at ASH 2025

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Regeneron will share 14 abstracts at the ASH 2025 Annual Meeting, covering blood cancers and disorders from December 6-9 in Orlando, FL.
Oral presentations include data on Lynozyfic (linvoseltamab-gcpt) monotherapy in newly diagnosed multiple myeloma (LINKER-MM4) and odronextamab plus chemotherapy as frontline treatment for diffuse large B-cell lymphoma (OLYMPIA-3).
Additional abstracts feature the cemdisiran + pozelimab combination versus ravulizumab in paroxysmal nocturnal hemoglobinuria and first-in-human results of REGN7257 in severe aplastic anemia.
Regeneron will host a virtual “Regeneron Roundtable” investor event on December 10 at 8:30 a.m. ET to discuss its multiple myeloma program.

Nov 13, 2025, 12:00 PM

Press Release

Immuneering reports Q3 2025 financial results and clinical progress

REGN

Earnings

Guidance Update

New Projects/Investments

86 % overall survival at 9 months in first-line pancreatic cancer patients treated with atebimetinib + mGnP (Phase 2a; N=34).
Raised $225 million of financing, including a $25 million private placement with Sanofi, extending cash runway into 2029.
Cash and cash equivalents of $227.6 million as of September 30, 2025 (vs. $36.1 million at December 31, 2024) and net loss of $15.0 million ($0.38 per share) in Q3 2025.
Key upcoming milestones: regulatory feedback and Phase 3 dosing in Q4 2025; updated survival data in 1H 2026; first pivotal Phase 3 patient dosed by mid-2026.

Nov 12, 2025, 9:05 PM

Press Release

Regeneron reports Q3 2025 results

REGN

Earnings

Share Buyback

Guidance Update

Regeneron's Q3 non-GAAP total revenues were $3.8 billion, up 1% YoY; diluted EPS was $11.83.
Top products: Dupixent global net sales $4.9 billion (+26% cc YoY), EYLEA HD U.S. net sales $431 million (+10% QoQ), and Libtayo global net sales $365 million (+24% cc YoY).
R&D investment continues with six positive Phase III data readouts across immunology, neurology, allergy, and rare diseases, and 2026 R&D expense expected to rise mid-teens %.
Generated $3.2 billion free cash flow YTD, repurchased $2.8 billion of shares thus far, and anticipates ~$4 billion in returns (dividends and buybacks) in 2025.

Oct 28, 2025, 12:30 PM

Transcript

Regeneron reports Q3 2025 results

REGN

Earnings

Guidance Update

Share Buyback

Regeneron’s Q3 revenues were $3.8 billion, up 1% year-over-year, with non-GAAP diluted EPS of $11.83.
Dupixent net sales reached $4.9 billion globally (up 26% at constant currency), including $3.6 billion in the U.S. (up 28%).
EYLEA HD U.S. net sales hit a record $431 million (up 10% sequentially), contributing to combined EYLEA sales of $1.11 billion in the quarter.
LIBTAYO delivered $365 million in worldwide net sales (24% cc growth), with U.S. sales of $219 million (12% growth).
The company generated $3.2 billion in free cash flow year-to-date, repurchased $2.8 billion of shares, and expects a mid-teens % increase in R&D expense in 2026 to support its robust pipeline.

Oct 28, 2025, 12:30 PM

Transcript

Regeneron reports Q3 2025 results

REGN

Earnings

Revenue Acceleration/Inflection

Regeneron delivered Q3 2025 total revenues of $3.75 billion and Non-GAAP EPS of $11.83.
Dupixent global net sales reached $4.9 billion (up 26% YoY), with over 1.3 million patients on therapy.
LIBTAYO posted Q3 WW net sales of $365 million (+24% YoY), including $219 million in the U.S. (+13% YoY), and exceeded $1 billion in YTD sales.
Pipeline highlights include a positive CHMP opinion for Dupixent in CSU, FDA approval for LIBTAYO in adjuvant CSCC, and upcoming Phase 3 readouts such as fianlimab in 1L metastatic melanoma expected in 1H 2026.

Oct 28, 2025, 12:30 PM

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