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REGENERON PHARMACEUTICALS, INC. (REGN)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 came in below Street: revenue $3.03B vs $3.24B consensus, and non-GAAP diluted EPS $8.22 vs $8.48 consensus; GAAP diluted EPS was $7.27. The miss was driven by a 30% sequential decline in total EYLEA/EYLEA HD net product sales and lower gross margin from higher inventory write-offs .
  • Dupixent momentum remained strong: global net sales rose 19% to $3.67B (recorded by Sanofi), lifting collaboration profits; Libtayo global sales grew 8% YoY to $285M .
  • Guidance: gross margin on net product sales was lowered by ~100 bps (GAAP to 83–84%, non-GAAP to 86–87%) and CapEx trimmed to $850–$950M; all other guidance items unchanged .
  • Catalysts: EYLEA HD sBLAs accepted for RVO and monthly dosing (PDUFA Aug 19, 2025), Dupixent CSU approved in the U.S., and EU approval of Lynozyfic (linvoseltamab) in R/R multiple myeloma; EYLEA HD pre-filled syringe received a CRL with a third-party component issue, which management expects to resolve expeditiously .

What Went Well and What Went Wrong

What Went Well

  • Dupixent execution: global net sales +19% YoY to $3.67B; CSU approval in the U.S. adds a seventh type-2 indication, and Japan approved COPD .
  • Libtayo progress: global sales +8% YoY to $285M, with U.S. +21% YoY; adjuvant CSCC filings in U.S./EU following Phase 3 DFS benefit and upcoming ASCO oral presentation .
  • Pipeline and manufacturing capacity: multiple regulatory submissions/approvals across oncology and immunology; 10-year FUJIFILM Diosynth agreement to nearly double U.S. large-scale manufacturing capacity and >$7B planned investments in NY/NC .

Quotes:

  • “We are laser focused on fulfilling the promise of this pipeline… and expect several important data readouts this year” — CEO Leonard Schleifer .
  • “We continue to deploy capital… through opportunistic share repurchases and our dividend program, which we initiated earlier this year” — CFO Christopher Fenimore .

What Went Wrong

  • EYLEA/EYLEA HD sequential decline: combined U.S. net product sales fell 30% QoQ due to lower wholesaler inventories and affordability-driven share loss to compounded bevacizumab; physician demand declined 11% sequentially .
  • Gross margin compression: GAAP gross margin on net product sales fell to 81% from 86% YoY, largely on higher inventory write-offs and reserves .
  • Regulatory speed bumps: FDA CRLs for EYLEA HD pre-filled syringe and extended dosing >16 weeks; pre-filled syringe CRL tied to a third-party component supplier’s DMF responses, adding timing uncertainty .

Financial Results

Revenue and EPS vs Prior Quarters

MetricQ3 2024Q4 2024Q1 2025
Total Revenues ($USD Millions)$3,720.7 $3,789.2 $3,028.7
GAAP Diluted EPS ($)$11.54 $8.06 $7.27
Non-GAAP Diluted EPS ($)$12.46 $12.07 $8.22

Margins YoY

MetricQ1 2024Q1 2025
GAAP Gross Margin on Net Product Sales (%)86% 81%
Non-GAAP Gross Margin on Net Product Sales (%)89% 85%

Product and Collaboration Breakdown (Q1 2025)

Metric ($USD Millions)Q1 2024Q1 2025YoY Change
EYLEA HD – U.S. Net Sales$200 $307 +54%
EYLEA – U.S. Net Sales$1,202 $736 -39%
Total EYLEA HD + EYLEA – U.S.$1,402 $1,043 -26%
Libtayo – Global Net Sales$264 $285 +8%
Total Net Product Sales$1,761 $1,416 -20%
Sanofi Collaboration Revenue$910 $1,183 +30%
Bayer Collaboration Revenue$356 $344 -3%
Other Revenue$117 $81.9 -30%
Total Revenues$3,145 $3,028.7 -4%

KPIs (Commercial Signals, Q1 2025)

KPIQ1 2024Q1 2025YoY Change
Dupixent Global Net Sales (Sanofi)$3,076.8 $3,665.6 +19%
EYLEA HD + EYLEA Global Net Sales$2,251.0 $1,900.6 -16%
Libtayo Global Net Sales$263.9 $285.1 +8%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
GAAP Gross Margin on Net Product SalesFY 202584%–85% 83%–84% Lowered
Non-GAAP Gross Margin on Net Product SalesFY 202587%–88% 86%–87% Lowered
Capital ExpendituresFY 2025$850–$975M $850–$950M Lowered top end
GAAP R&DFY 2025$5.560–$5.795B Unchanged Maintained
Non-GAAP R&DFY 2025$5.000–$5.200B Unchanged Maintained
GAAP SG&AFY 2025$2.910–$3.095B Unchanged Maintained
Non-GAAP SG&AFY 2025$2.550–$2.700B Unchanged Maintained
COCMFY 2025$1.000–$1.150B Unchanged Maintained
GAAP ETRFY 20259%–11% Unchanged Maintained
Non-GAAP ETRFY 202511%–13% Unchanged Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
EYLEA HD pre-filled syringeExpected mid-2025 decision; emphasized label enhancements incl. RVO and dosing flexibility FDA CRL tied to third-party DMF component; no safety/efficacy issues; aiming to resolve quickly Near-term delay; resolution expected
Anti-VEGF market dynamics & copayCategory leadership; competitive pressures; wholesaler inventory swings Funding gap at charitable copay foundations drove share to Avastin; Regeneron exploring donation matching program Affordability headwind intensified
Dupixent growth & new indicationsCOPD approvals in U.S./EU/China; CSU and BP pivotal data; sBLAs in flight CSU approved in U.S.; COPD momentum and payer coverage strong; DTC campaign underway Expanding label and uptake
Libtayo strategy (adjuvant CSCC, melanoma combo)Adjuvant CSCC DFS win; Phase 3 LAG-3 combo data anticipated 2H 2025 Adjuvant CSCC filings submitted; U.S. demand rising; combo programs continue Building toward launches
Tariffs & U.S. manufacturingMonitoring sector tariffs; large investments in U.S. facilities; dividend/share buybacks Tariff impact uncertain; FUJIFILM Diosynth agreement to nearly double U.S. capacity; >$7B NY/NC investments Capacity expansion offsets macro risk
Regulatory operationsMultiple submissions and approvals across pipeline mgmt addressed heightened FDA scrutiny of third-party manufacturers; accepted responsibility while defending team Navigating scrutiny; process discipline

Management Commentary

  • CEO on pipeline and commercial focus: “We are laser focused on fulfilling the promise of this pipeline… and expect several important data readouts this year… ensure our four blockbuster medicines reach even more patients” .
  • CEO on pre-filled syringe CRL: “We believe the key outstanding issue relates to a question posed by the FDA to a third-party component supplier… the supplier has expeditiously responded… the FDA will move expeditiously” .
  • CFO on guidance change: “We have updated our 2025 gross margin guidance to be in the range of 86% to 87%. This change is primarily driven by higher-than-expected inventory write-offs in the first quarter” .
  • Commercial lead on anti-VEGF market: “Low-cost off-label repackaged Avastin increased its anti-VEGF category share by ~6pp to 32%… EYLEA HD and EYLEA captured 41% of the category” .

Q&A Highlights

  • Pre-filled syringe timing: Management explained DMF process constraints and third-party data exchange, aiming for quick resolution; no reinspection expected .
  • Charitable copay support: Regeneron explored a donation matching program to broaden funding beyond Regeneron as foundations reopen; reiterated inability to correlate funding to product usage .
  • Regulatory performance: CEO acknowledged responsibility, citing post-COVID FDA scrutiny of contract manufacturers as a driver of CRLs/delays; reaffirmed team strength .
  • Tariffs and policy: CFO noted uncertainty around sector-specific tariffs; CEO emphasized engagement with Washington and the importance of science-based policy continuity .

Estimates Context

MetricQ1 2025 ConsensusQ1 2025 Actual
Revenue ($USD Millions)3,239.3*3,028.7
Primary EPS ($)8.48*8.22
  • Both revenue and EPS missed consensus; Street models likely need to reflect lower near-term anti-VEGF category demand and reduced gross margin trajectory due to inventory write-offs .
  • Values with * were retrieved from S&P Global.

Key Takeaways for Investors

  • Expect near-term pressure from affordability-driven Avastin share and EYLEA/EYLEA HD inventory normalization; gross margin headwinds already reflected in updated guidance .
  • Dupixent remains the core growth engine with expanding indications (CSU U.S. approval, COPD momentum), sustaining Sanofi collaboration profit share uplift .
  • EYLEA HD catalysts (RVO label, monthly dosing) and eventual resolution of pre-filled syringe CRL can re-accelerate HD adoption; watch the August 19 PDUFA and CRL remediation updates .
  • Oncology optionality increasing: Libtayo adjuvant CSCC filing and melanoma combo readout (2H 2025) can add new revenue streams; Lynozyfic EU approval provides hematology foothold .
  • Capital deployment remains supportive (dividend, buybacks) while U.S. manufacturing expansion mitigates supply/capacity risks amid tariff uncertainty .
  • Estimates likely drift down for Q2 on gross margin/product mix and anti-VEGF dynamics; focus on second-half pipeline readouts and EYLEA HD label actions as inflection points .

Additional Data and Document Citations:

  • Q1 2025 press release and detailed financial tables .
  • Q1 2025 8-K including exhibit and guidance reconciliation .
  • Q1 2025 earnings call transcript prepared remarks and Q&A .
  • Q4 2024 press release/8-K and earnings call for prior-quarter comparisons .
  • Q3 2024 press release for prior two quarters’ trend context .

S&P Global Disclaimer: Consensus estimates marked with an asterisk (*) were retrieved from S&P Global.