What is the revenue and EPS growth rate for Regeneron year over year?

What guidance did Regeneron's management provide for the next earnings period?

What is the market's earnings forecast for Regeneron next quarter?

What were the key takeaways from Regeneron’s earnings call?

What is Regeneron's latest dividend and current dividend yield?

What factors drove the changes in Regeneron's revenue and profit?

What is Regeneron's gross profit margin?

What does Regeneron do and what are its main business segments?

- **Revenue Growth**: Q3 net sales $3.8B (+1% YoY), driven by 26% Dupixent and 24% Libtayo growth.
- **Pipeline Breakthroughs**: 6 Phase III programs advancing; Lynozyfic shows 83% ORR in myeloma, Dupixent expands into AFRS.
- **Manufacturing Expansion**: $7B+ US investment; new filler plant coming online 2026 to resolve EYLEA HD supply chain issues.
- **Financial Strength**: $3.2B free cash flow (9M), $2.8B share buybacks YTD, 2026 R&D +15% YoY.
- **Strategic Focus**: Balancing US drug pricing reform with innovation; 2025 guidance narrowed, 2026 pipeline expansion.

**【CEO Summary Section】**
- **Q3 Financial Highlights**: Total revenues $3.8B (+1% YoY), driven by Dupixent (+26%), Libtayo (+24%), and EYLEA HD (+10%).
- **Product Performance**: Dupixent global sales $4.9B, EYLEA HD US sales $431M (all-time high), Libtayo US sales $219M (+12%).
- **Pipeline Progress**: 6 Phase III programs across immunology, oncology, and rare diseases; Dupixent expansion into AFRS, itepekimab for COPD, and Lynozyfic in myeloma.
- **Strategic Initiatives**: $7B+ investment in US manufacturing; discussions with US govt on drug pricing reform.

**【CFO Financial Commentary】**
- **Revenue Breakdown**: Sanofi collaboration $1.6B (+30%), Bayer $345M, other revenue $198M.
- **Expense Management**: R&D $1.3B (+19%), SG&A $541M (-12%) due to reduced charitable contributions.
- **Cash Flow**: $3.2B free cash flow (9M), $16B cash/marketables, $2.8B share buybacks YTD.
- **2025 Guidance**: Narrowed ranges for all metrics; 2026 R&D +15% YoY.

**【Q&A Highlights】**
- **EYLEA HD Strategy**: Focus on clinical efficacy, durability, and label enhancements (4wk dosing, RVO). Q4 demand growth expected 5-10%.
- **Manufacturing**: $7B+ US manufacturing expansion; new filler plant coming online 2026.
- **Pipeline Momentum**: Lynozyfic Phase III in myeloma, Factor XI anticoagulant trials, and siRNA programs in rare diseases.
- **Regulatory Challenges**: FDA delays on EYLEA HD sBLA; alternative filler approvals expected late 2025.
- **Innovation**: Gene therapy for FOP, hearing loss; CD3 antibody for uveitis/glaucoma; allergy monoclonal antibodies in Phase III.

Regeneron Pharmaceuticals, Inc. (REGN) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: Q2 2025 total revenues $3.7B (+4% YoY), driven by Dupixent (+21% CER), Libtayo (+25% CER), and EYLEA HD ($393M all-time high). Diluted EPS $12.89 (+12% YoY).
- **Pipeline Breakthroughs**: Lynozyfic achieves 100% CR in high-risk myeloma; odronextamab Phase III enrollment complete. C5 siRNA myasthenia gravis data expected Q3.
- **Capital Deployment**: $2.2B in share buybacks YTD; $7B+ invested in U.S. manufacturing and R&D.
- **EYLEA Challenges**: U.S. net sales down 39% YoY due to biosimilars; EYLEA HD enhancements delayed until Q4 2025 due to FDA inspection.
- **Strategic Focus**: Internal R&D ($>5B/year) prioritized over acquisitions, with 45+ pipeline programs targeting $30B+ markets.

**【CEO Summary Section】**
- **Q2 2025 Financial Highlights**: Total revenues of $3.7 billion, up 4% YoY, driven by Dupixent ($4.3 billion, +21% CER), Libtayo ($377 million, +25% CER), and EYLEA HD ($393 million, all-time high). Diluted EPS grew 12% to $12.89.
- **Pipeline Momentum**: 45+ R&D programs, including Lynozyfic (BCMAxCD3 bispecific) with 100% CR in high-risk smoldering myeloma and odronextamab (CD20xCD3) in first-line follicular lymphoma. Phase III data expected for C5 siRNA in myasthenia gravis (Q3 2025).
- **Capital Allocation**: $7 billion+ invested in U.S. manufacturing and R&D; $2.2 billion in share buybacks YTD, with $2.8 billion remaining under repurchase program.

**【CFO Financial Commentary】**
- **Revenue Breakdown**: Sanofi collaboration ($1.4B, +30% YoY), Bayer ($415M, +11% YoY), and other revenue ($184M, +70% YoY). Gross margin 86%, lower due to inventory write-offs and manufacturing investments.
- **Expense Management**: R&D ($1.3B) and SG&A ($542M, -19% YoY) reflect focus on pipeline and cost control. Free cash flow $1.7B for H1, ending Q2 with $17.5B in cash.
- **Guidance Update**: Adjusted gross margin guidance to 84-86% (from 85-87%) due to manufacturing costs; no immediate impact from U.S.-EU trade agreement tariffs.

**【Q&A Highlights】**
- **EYLEA Dynamics**: U.S. net sales down 39% YoY due to biosimilar competition and EYLEA HD switch; EYLEA HD unit demand +16% QoQ. FDA delays for EYLEA HD enhancements (e.g., 4-week dosing) due to Catalent site inspection; resolution expected by Q4 2025.
- **Pipeline Confidence**: Lynozyfic (myeloma) and odronextamab (lymphoma) Phase III trials fully enrolled; C5 siRNA in myasthenia gravis expected to read out Q3. Dupixent expansion into allergies (birch, cat) and COPD shows strong patient demand.
- **MFN Policy Impact**: Management agrees with U.S. government on need for Europe to pay fair share for innovation but warns against U.S. price cuts without reciprocal changes. EYLEA's global branded share remains >60% despite Avastin affordability gains.
- **Business Development**: Open to later-stage acquisitions in high unmet need areas (e.g., NASH, neurodegenerative diseases), but prioritizes internal R&D (>$5B annual spend).

Regeneron Pharmaceuticals, Inc. (REGN) Q2 2025 Earnings Call Transcript

- **EYLEA HD Growth**: 54% YoY sales growth, despite CRL delay for pre-filled syringe tied to third-party component.
- **Dupixent Dominance**: 20% global sales growth, leading in new-to-brand prescriptions across all indications.
- **Pipeline Momentum**: 45 clinical candidates with 4 approvals and 9 submissions in 2025, including linvoseltamab and odronextamab launches.
- **Financial Strength**: $3B revenue, $8.22 EPS, $816M free cash flow, and $1.1B share buybacks.
- **Regulatory Challenges**: FDA delays linked to third-party suppliers, but pipeline progress remains robust.

**【CEO Opening Remarks】**
- **EYLEA/EYLEA HD Performance**: U.S. net sales for EYLEA dropped 39% YoY due to competitive pressures, while EYLEA HD grew 54% YoY. Regulatory delays for the pre-filled syringe (CRL) are being addressed, with the FDA focusing on a third-party component supplier's data submission.
- **Dupixent Growth**: Global net sales rose 20% YoY, driven by strong performance across all approved indications. COPD launch momentum is accelerating, with broad payer coverage and a direct-to-consumer campaign.
- **Pipeline Progress**: 45 clinical candidates in development, including 4 regulatory approvals and 9 submissions. Key 2025 milestones include linvoseltamab (multiple myeloma), odronextamab (follicular lymphoma), and EYLEA HD label enhancements.

**【CFO Financial Highlights】**
- **Q1 2025 Financials**: Total revenue $3B, diluted EPS $8.22. Collaboration revenue with Sanofi grew 27% YoY, driven by Dupixent volume. Bayer collaboration revenue was $344M, reflecting EYLEA 8mg sales growth.
- **Expense Management**: R&D expenses $1.2B (modest YoY growth), SG&A down 8% YoY due to lower G&A costs. Gross margin on net product sales was 85%, impacted by inventory write-offs and product mix.
- **Cash Flow & Capital Return**: Free cash flow $816M. Share repurchases $1.1B (remaining $3.9B), with a new quarterly dividend ($0.88 per share) initiated.

**【Q&A Key Takeaways】**
- **EYLEA HD Syringe CRL**: FDA's focus on a third-party component supplier's data; resolution could take months. Europe-approved design and components add confidence in eventual approval.
- **Patient Assistance Funding**: $400M+ annually supported via independent foundations. A proposed matching program aims to engage other stakeholders, but reopening depends on external contributions.
- **Pipeline Prioritization**: Factor XI antibodies target anticoagulation with lower bleeding risk. Phase 3 trials expected to enroll this year in both large and niche patient populations.
- **Regulatory Environment**: FDA scrutiny of third-party suppliers is causing delays, but Regeneron's regulatory team is proactive in resolving issues.


Regeneron Pharmaceuticals (REGN)-29 Apr 25-2025 Q1 Earnings call transcript

- **Topline Growth**: 10% Q4 revenue growth driven by Dupixent (+15%), Libtayo ($1.2B global sales), and EYLEA/EYLEA HD ($1.5B U.S. sales)
- **Pipeline Catalysts**: 
  - EYLEA HD 24-week dosing FDA submission Q3 2025
  - Libtayo melanoma Phase 3 data H2 2025
  - Dupixent COPD 90% Medicare coverage
- **Capital Return**: $3B share buyback + $0.88 quarterly dividend
- **Key Risks**: EYLEA biosimilar competition, $1.6B Sanofi development balance
- **Pipeline Momentum**: 40+ clinical programs, including Factor XI Phase 3 starts in 2025

**【CEO Summary Section】**
- Regeneron reported 10% year-over-year revenue growth in Q4 2024, driven by key franchises: Dupixent (+15% U.S. net sales), Libtayo (blockbuster status with $1.2B global sales), and EYLEA/EYLEA HD ($1.5B U.S. net sales). 
- Pipeline highlights include: 
  - Dupixent COPD launch with 85% U.S. commercial coverage
  - EYLEA HD Q3 2025 FDA submissions for RVO and 24-week dosing
  - Libtayo adjuvant CSCC Phase 3 data showing 68% DFS improvement vs. placebo
  - $3B share repurchase authorization and first quarterly dividend ($0.88/share)

**【CSO Pipeline Update】**
- **EYLEA HD**: Phase 3 QUASAR study shows non-inferiority to EYLEA at 8-week dosing; 90% of patients maintained 8-week intervals
- **Dupixent**: 
  - COPD U.S. launch with 90% Medicare coverage
  - CSU FDA approval target April 2025
  - Bullous pemphigoid BLA submission
- **Oncology**: 
  - Libtayo Phase 3 melanoma data expected H2 2025
  - Linvoseltamab (BCMAxCD3) BLA resubmission
  - Odronextamab (CD20xCD3) follicular lymphoma Phase 3 enrollment >40%
- **Factor XI**: 
  - REGN7508 superior to enoxaparin in VTE prevention
  - REGN9933 lower bleeding risk profile

**【Commercial Performance】**
- **EYLEA/EYLEA HD**: 
  - 46% U.S. anti-VEGF category share
  - EYLEA HD net sales $1.2B (20% of total)
  - Q4 2024 EYLEA HD syringe launch
- **Dupixent**: 
  - 1M+ patients globally
  - 24% U.S. prescription growth
  - COPD 30+ country approvals
- **Libtayo**: 
  - 50% YoY growth in U.S. net sales
  - Lung cancer expansion

**【Financial Highlights】**
- Q4 2024: 
  - Total revenue $3.8B (+10% YoY)
  - Non-GAAP EPS $12.07
  - Free cash flow $3.7B
- 2025 Guidance: 
  - R&D spend $5-5.2B
  - SG&A $2.55-2.7B
  - Gross margin 87-88%
  - Tax rate 11-13%


Regeneron Pharmaceuticals, Inc. (REGN) Q4 2024 Earnings Call Transcript

Regeneron Pharmaceuticals (REGN)-31 Oct 24-2024 Q3 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-1 Aug 24-2024 Q2 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-2 May 24-2024 Q1 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-2 Feb 24-2023 Q4 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-2 Nov 23-2023 Q3 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-3 Aug 23-2023 Q2 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-4 May 23-2023 Q1 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-3 Feb 23-2022 Q4 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-3 Nov 22-2022 Q3 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-3 Aug 22-2022 Q2 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-4 May 22-2022 Q1 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-4 Feb 22-2021 Q4 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-4 Nov 21-2021 Q3 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-5 Aug 21-2021 Q2 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-6 May 21-2021 Q1 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-5 Feb 21-2020 Q4 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-5 Nov 20-2020 Q3 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-5 Aug 20-2020 Q2 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-5 May 20-2020 Q1 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-6 Feb 20-2019 Q4 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-5 Nov 19-2019 Q3 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-6 Aug 19-2019 Q2 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-7 May 19-2019 Q1 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-6 Feb 19-2018 Q4 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-6 Nov 18-2018 Q3 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-2 Aug 18-2018 Q2 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-3 May 18-2018 Q1 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-8 Feb 18-2017 Q4 Earnings call transcript

Regeneron Pharmaceuticals (REGN)-8 Nov 17-2017 Q3 Earnings call transcript

REGN

REGN fundamentals

Earnings Call

You can ask Aime