Executive Summary

Q3 2025 was a clean beat: revenue $3.75B (+1% YoY) and non-GAAP diluted EPS $11.83, both above Street; GAAP diluted EPS was $13.62, with a $0.68 headwind from acquired IPR&D charges . Versus S&P Global consensus, revenue beat by ~$0.17B (+4.6%)* and EPS by ~$2.19 (+22.7%)*.
Mix dynamics: Dupixent strength (Sanofi collaboration profit share +34% YoY) and Libtayo growth offset U.S. EYLEA 2mg declines; EYLEA HD demand remained strong but pricing pressured gross margin (non-GAAP GM on product sales 86% vs 89% in 3Q24) .
2025 guidance was tightened: GAAP GM lowered (to ~82%), GAAP/Non-GAAP SG&A reduced, COCM and Capex lowered, GAAP ETR raised to ~14%; Non-GAAP ETR narrowed to ~12% .
Near-term catalysts: FDA decisions on EYLEA HD every-4-week/RVO sBLA (late Nov/Dec); remediation of prefilled syringe CRL via alternate filler in 1Q26; Libtayo adjuvant CSCC launch; investor “Roundtable” data drops (Factor XI Nov 10; oncology/obesity later) .

What Went Well and What Went Wrong

What Went Well
- Dupixent momentum: Regeneron’s share of antibody collaboration profits rose to $1.46B (from $1.09B), driven by higher Dupixent sales; global Dupixent net sales (Sanofi) grew 27% YoY to $4.86B .
- Libtayo execution: Global net sales $365M (+26% YoY), with U.S. +12% and ROW +55% YoY; now approved as first/only immunotherapy in high-risk adjuvant CSCC; early launch traction and up to 10,000 addressable U.S. patients highlighted .
- Pipeline/regulatory progress: Positive Phase 3 data across multiple programs (GMG, FOP, allergen-blocking antibodies) and DB-OTO voucher; CEO: “solid financial quarter” with progress across late-stage portfolio .
What Went Wrong
- EYLEA 2mg headwinds: U.S. EYLEA net sales fell 41% YoY to $681M due to competition, affordability (shift to compounded bevacizumab), and conversion to EYLEA HD; total EYLEA franchise U.S. -28% YoY to $1.11B .
- Manufacturing/filler bottlenecks: CRL for EYLEA HD prefilled syringe tied to Catalent OAI; alternate vial filler submitted (PDUFA late Dec) and alternate PFS filler submission planned by Jan 2026; label enhancements’ timing remains a gating factor .
- Margin/tax drag: Non-GAAP product GM down to 86% (from 89% 3Q24) on manufacturing investments; GAAP ETR rose to 17.2% (from 10.2%) on the OBBBA deferred tax charge and lower option-exercise tax benefits .

Financial Results

Overall P&L vs prior quarters and YoY (all $USD billions unless noted)

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Total Revenues	$3.721	$3.029	$3.676	$3.754
GAAP Diluted EPS ($)	$11.54	$7.27	$12.81	$13.62
Non-GAAP Diluted EPS ($)	$12.46	$8.22	$12.89	$11.83
GAAP GM on Net Product Sales	87%	81%	83%	82%
Non-GAAP GM on Net Product Sales	89%	85%	86%	86%

Estimate comparison (S&P Global consensus vs actual)

Metric	Q1 2025	Q2 2025	Q3 2025
Revenue Consensus Mean ($B)	$3.239*	$3.278*	$3.589*
Revenue Actual ($B)	$3.029	$3.676	$3.754
Primary EPS Consensus Mean ($)	8.48*	8.44*	9.64*
Non-GAAP Diluted EPS Actual ($)	8.22	12.89	11.83

Values retrieved from S&P Global.*

Key revenue drivers and mix (Q3 2025)

Component	Q3 2024	Q3 2025	YoY
EYLEA HD – U.S. ($M)	$392	$431	+10%
EYLEA – U.S. ($M)	$1,145	$681	-41%
Total EYLEA HD + EYLEA – U.S. ($M)	$1,537	$1,112	-28%
Libtayo – Global ($M)	$289	$365	+26%
Sanofi Collaboration Revenue ($M)	$1,263	$1,617	+28%
Bayer Collaboration Revenue ($M)	$391	$345	-12%
Other Revenue ($M)	$114	$198	+74%
Total Revenues ($M)	$3,721	$3,754	+1%

Operating expenses and tax (Q3 2025)

Metric	Q3 2024	Q3 2025
GAAP R&D ($M)	$1,272	$1,475
Non-GAAP R&D ($M)	$1,146	$1,350
GAAP SG&A ($M)	$714	$658
Non-GAAP SG&A ($M)	$613	$541
GAAP ETR	10.2%	17.2%
Non-GAAP ETR	10.7%	13.1%

KPI/Drivers (Q3 2025)

KPI	Value
Dupixent Global Net Sales (Sanofi) ($M)	$4,857
Regeneron share of antibody profits – Sanofi ($M)	$1,455.5
Regeneron share of Bayer EYLEA/EYLEA HD OUS profits ($M)	$311.9
EYLEA HD U.S. unit demand QoQ	+18%
EYLEA U.S. net sales QoQ	-10%

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
GAAP R&D	FY2025	$5.660–$5.790B	$5.680–$5.750B	Narrowed; slightly lower midpoint
Non-GAAP R&D	FY2025	$5.100–$5.200B	$5.150–$5.200B	Narrowed; raised low end
GAAP SG&A	FY2025	$2.810–$2.940B	$2.775–$2.845B	Lowered
Non-GAAP SG&A	FY2025	$2.450–$2.550B	$2.400–$2.450B	Lowered
GAAP Gross Margin on Net Product Sales	FY2025	~83%	~82%	Lowered
Non-GAAP Gross Margin on Net Product Sales	FY2025	~86%	~86%	Maintained
COCM	FY2025	$1.000–$1.050B	$0.95–$1.00B	Lowered
Capital Expenditures	FY2025	$880–$950M	$850–$890M	Lowered
GAAP ETR	FY2025	11%–13%	~14%	Raised
Non-GAAP ETR	FY2025	11%–13%	~12%	Narrowed

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3 2025)	Trend
EYLEA HD label/fillers	Q1: PFS CRL; monthly/RVO priority review accepted . Q2: anticipated delays from Catalent OAI; alternates progressing .	FDA CRL for PFS tied to Catalent OAI; alternate vial filler filed (PDUFA late Dec); alternate PFS filler filing by Jan 2026; label enhancements a key demand unlock .	Bottleneck being worked; path to resolution defined
Dupixent growth/indications	Q1 CSU approval U.S.; COPD Japan . Q2 BP approval U.S.; continued growth .	27% YoY net sales growth; CHMP positive for CSU; 1.3M+ patients; new AFRS submission planned .	Strengthening
Libtayo	Q2: sBLA priority review adjuvant CSCC .	FDA approval adjuvant CSCC; early launch traction; NSCLC 5-year survival data; U.S./ROW growth .	Expanding
Bispecifics (Lynozyfic/undronextimab)	Q2: Lynozyfic FDA/EC approvals; confirmatory trial progress .	Early U.S. launch signals; aggressive earlier-line programs; plan up to 10 registrational trials .	Broadening
Factor XI anticoagulation	Q2: Phase 3 initiated in VTE post-TKR; more Phase 3 planned .	Roundtable Nov 10 to share new data; tailoring benefit-risk across settings .	Readouts ahead
Affordability/patient assistance	Q1: Affordability weighed on EYLEA; compounded bevacizumab uptake . Q2: Launched $200M matching program .	Matching under $1M in Q3; will reassess best strategy next year .	Ongoing headwind
Tax/ETR	—	GAAP ETR up on OBBBA $45M deferred tax remeasurement; non-GAAP ETR 13.1% .	One-time headwind

Management Commentary

CEO tone: “Regeneron had a solid financial quarter and made progress across our late-stage portfolio…” .
Commercial focus: “EYLEA HD unit demand grew 18% QoQ… we anticipate sequential demand growth to moderate to high single digits as we await label enhancements.” – Marion McCourt .
Manufacturing self-sufficiency: “We expect our filling plant… to come online during the coming year,” to control biologics manufacturing end-to-end – Leonard Schleifer .
2026 investment: “We currently expect a mid-teens % increase in R&D expense in 2026 relative to 2025.” – CFO Chris Fenimore .

Q&A Highlights

EYLEA HD strategy: Management avoided detailing pricing tactics but reiterated demand strength for HD and that material upswing awaits label enhancements; EYLEA 2mg demand expected to decline similarly in 4Q .
Filler remediation timeline: Alternate vial filler could enable approval alongside late-Nov/Dec PDUFAs; alternate PFS filler filing targeted by Jan 2026; nothing else outstanding on application per discussions with FDA .
Internal fill/finish: Company’s own filling capacity to come online next year, improving control over a past bottleneck .
Factor XI program: Focus on optimizing benefit–risk; see broader opportunities beyond SPAF where bleeding risk constrains anticoagulant use .
Lynozyfic expansion: Planning up to 10 registrational trials and pushing into earlier lines/pre-malignant settings; aiming to work with FDA on acceleration .

Estimates Context

Q3 2025: Revenue $3.75B vs $3.59B consensus (+4.6%); non-GAAP diluted EPS $11.83 vs $9.64 consensus (+22.7%), driven by Dupixent profit share and Libtayo growth offsetting U.S. EYLEA declines .
Q2 2025: Revenue $3.68B vs $3.28B (+12.1%); EPS $12.89 vs $8.44 (+52.7%) .
Q1 2025: Revenue $3.03B vs $3.24B (-6.5%); EPS $8.22 vs $8.48 (-3.0%); sequential recovery through Q2–Q3 .
Values retrieved from S&P Global.*

Where estimates may adjust: modest upward revisions likely to EPS and revenue trajectories for 2H25–2026 tied to Dupixent profit share and Libtayo launch progression; margin expectations may embed sustained manufacturing investment and a higher GAAP ETR (~14%) .

Key Takeaways for Investors

Dupixent remains the engine: collaboration profit share hit $1.46B in Q3; durability across new indications (CSU, BP) underpins continued upside .
EYLEA HD afloat amid affordability pressure: unit demand is robust, but price mix caps revenue; label enhancements (every-4-week, RVO, prefilled syringe) are the near-term swing factor (late Nov/Dec/Jan timeline) .
Libtayo is a tangible second growth pillar: adjuvant CSCC approval with early traction plus lung expansion and 5-year OS data support sustained growth .
2025 guidance mix shift: lower SG&A, COCM, and Capex offset lower GAAP GM and higher GAAP ETR—net implies disciplined OpEx with portfolio investment intact .
2026 investment ramp: plan for mid-teens % R&D increase—pipeline catalysts (bispecifics, Factor XI, ophthalmology gene/immune targets) warrant longer-term capital deployment .
Manufacturing risk mitigation: internal filling capacity coming online in 2026 should reduce third-party filler risk exposure evident in recent CRLs .
Trading setup: into year-end, watch FDA timing on EYLEA HD filings (late Nov/Dec) and Roundtable data events; positive outcomes could re-accelerate HD adoption and support multiple expansion on pipeline visibility .

Citations: All document figures and statements are sourced from Regeneron’s Q3 2025 8-K/press release and earnings call transcript, Q1–Q2 2025 8-Ks, and relevant press releases as cited inline. Estimates are from S&P Global, as marked with an asterisk.

REGENERON PHARMACEUTICALS, INC. (REGN)·Q3 2025 Earnings Summary