Q3 2024 Earnings Summary
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
EYLEA HD | • Q2 2024: $1.53B (+2.3% YoY) combined sales, fastest-growing anti-VEGF launch since original EYLEA. • Q1 2024: $200M in net sales, significant sequential growth. • Q4 2023: $123M in first full quarter after launch. | • Combined U.S. net sales of $1.54B (up 3% YoY) and 44% total anti-VEGF market share. • Strong confidence in durability, efficacy, and future growth. | Consistently strong performance and positive sentiment across all periods. |
Biosimilar competition for EYLEA | • Q2 2024: Not mentioned. • Q1 2024: Not mentioned. • Q4 2023: Patent litigation success mentioned, potentially delaying biosimilars. | • Emphasized EYLEA HD differentiation (durability, efficacy, safety) to compete against biosimilars. Mentioned overall pricing pressure in anti-VEGF market. | Newly discussed in Q3 2024 (relative to Q2/Q1), continuing confidence in EYLEA HD. |
EYLEA price erosion | • Q2 2024: Noted lower volumes and lower price for EYLEA amid market dynamics. • Q1 2024: Not mentioned. • Q4 2023: Acknowledged price erosion and competitive market. | • Ongoing pricing pressure in anti-VEGF category, partially offset by product’s clinical advantages. | Consistent mention in Q3, Q2, and Q4, reflecting a challenging pricing environment. |
Prefilled syringe launch for EYLEA HD | • Q2 2024: Potential early 2025 launch mentioned. • Q1 2024: Not mentioned. • Q4 2023: Not mentioned. | • Expected mid-2025; described as a key differentiator to strengthen EYLEA HD’s competitive profile. | Ongoing development, first mentioned Q2, reaffirmed in Q3. |
Dupixent expansions (COPD, next-gen) | • Q2 2024: BOREAS & NOTUS COPD data positive, sBLA under review. • Q1 2024: Preparing for first COPD biologic launch. • Q4 2023: Emphasized as first major COPD advance in a decade. | • COPD: Approved in U.S., EU, China; positive physician interest. • Next-gen: CSU, bullous pemphigoid, pediatric EoE, etc. showing strong potential. | Consistently prominent, positive sentiment each quarter, large future impact anticipated. |
Food allergy therapy (Dupixent + Linv.) | • Q2 2024: Discussed pilot study and potential to eliminate severe food allergies. • Q1 2024: Proof-of-concept trial in progress. • Q4 2023: Mentioned novel approach using BCMAxCD3 + Dupixent. | • No mention. | No longer mentioned in Q3, previously highlighted in Q2/Q1/Q4. |
Linvoseltamab | • Q2 2024: FDA review delayed by third-party manufacturing issue, strong efficacy/safety profile. • Q1 2024: 71% ORR, best-in-class potential. • Q4 2023: FDA/EMA filings accepted, high excitement around launch. | • Multiple myeloma data: ~71% overall response, 50% complete response or better; exploring earlier-line settings. • Potential application in severe food allergies (combo with Dupixent). | Healthy momentum across all periods, remains a strategic focus. |
Odronextamab setbacks | • Q2 2024: Not mentioned. • Q1 2024: Not mentioned. • Q4 2023: BLA decision expected by March 31, 2024, no setbacks discussed. | • Not mentioned. | Not discussed this year, no setbacks reported. |
Weight loss + muscle preservation | • Q2 2024: Myostatin antibody + semaglutide combo to address muscle loss. • Q1 2024: Highlighted specificity vs. broader blockers, aiming to preserve functional muscle. • Q4 2023: Developing tethered GLP-1 with muscle-blocking antibodies. | • Emphasized preventing lean mass loss with rapid GLP-1-induced weight loss; exploring “unimolecular solutions” and expanded dosing arms. | Continues as a major R&D focus, positive sentiment on differentiation. |
C5 complement blockade (GA) | • Q2 2024: Phase III GA program set to start 2H24. • Q1 2024: Planning first pivotal study in GA. • Q4 2023: Systemic approach vs. local injection; positive PNH data supporting GA expansion. | • Not mentioned in Q3 2024. | No Q3 mention, but ongoing in prior quarters, significant future potential. |
2seventy bio cell therapy programs | • Q2 2024: Not mentioned. • Q1 2024: Acquired CAR-T programs for autoimmune diseases. • Q4 2023: Full rights acquired, employees integrated into Regeneron Cell Medicines. | • Not mentioned. | No current updates in Q3, previously mentioned in Q1/Q4. |
DOJ investigation (EYLEA marketing) | • Q2 2024: Investigation noted; Regeneron stated no changes to marketing practices, lawsuit vigorously contested. • Q1/Q4 2024: Not mentioned. | • Not mentioned. | No further discussion beyond Q2. |
Retinal disease market growth | • Q2 2024: Single-digit midrange growth. • Q1 2024: Healthy interest in EYLEA HD uptake. • Q4 2023: Slight slowdown vs. prior year but still healthy. | • Category growing in mid-single digits. | Consistent moderate growth references each quarter. |
Regulatory/PDUFA delays | • Q2 2024: Linvoseltamab approval delayed over third-party inspection issue. • Q1 2024: FDA additional data request could delay Dupixent COPD. • Q4 2023: EYLEA HD and odronextamab timelines discussed. | • No new updates on PDUFA delays in Q3. | No Q3 mention, significant in earlier quarters. |
Capital return initiatives | • Q2 2024: Not mentioned. • Q1 2024: $300M shares repurchased, new $3B authorization. • Q4 2023: Over $2.2B buybacks in 2023, $1.5B remaining, top priority is R&D funding. | • ~$1.6B in share repurchases through first nine months, $2.9B remaining authorization; possible future dividend after development balance to Sanofi is paid. | Resumed in Q3 after no Q2 mention; ongoing buybacks, dividend hinted. |
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EYLEA vs. Biosimilars
Q: How will biosimilars affect EYLEA, and plans for EYLEA HD?
A: Management expressed confidence in EYLEA's strong performance and safety record, noting it has delivered around 100 million injections. They acknowledge the entry of a biosimilar but believe EYLEA HD is a differentiated product that will compete well. They plan to continue educating doctors about its benefits and are providing more data, including long-term results that are "rather striking". -
EYLEA HD Prefilled Syringe Launch
Q: What impact will the EYLEA HD prefilled syringe have?
A: They anticipate launching the EYLEA HD prefilled syringe by mid-next year, expecting it to be a catalyst for acceleration. Doctors prefer prefilled syringes, and they believe their product will be differentiated due to its design to withstand millions of injections without causing inflammation, an issue seen with competitors. -
Pricing Pressure on EYLEA HD
Q: Explain the pricing pressures on EYLEA HD and future outlook.
A: Management acknowledges pricing pressure in the anti-VEGF category affecting all products, including EYLEA HD. They attribute this to competitive factors consistent with other markets but believe EYLEA HD's clinical profile, safety, and durability position it well to compete successfully despite these pressures. -
Capital Allocation Amid Biosimilar Entry
Q: How will biosimilar competition influence capital allocation?
A: They will not adjust spending based on biosimilar entry. The company intends to continue investing appropriately based on opportunities, emphasizing their strong balance sheet and commitment to bringing innovative products to market rather than focusing on biosimilars. -
Obesity Program Trial Expansion
Q: Why expand the obesity trial with new arms?
A: They added additional dosing arms to explore different doses aimed at muscle preservation, intending to find the right mix to maximize the quality of weight loss. This expansion allows for broader information on dosing and effects. -
Regulatory Path for Muscle Preservation
Q: Discuss the regulatory path for muscle-preserving obesity treatments.
A: Management aims to maintain muscle while increasing weight loss, recognizing the significant loss of lean body mass with current GLP treatments. The simplest regulatory path is demonstrating increased weight loss with better composition, supported by metabolic and functional improvements. -
Factor XI Program Expectations
Q: What are the expectations for the upcoming Factor XI readouts?
A: They are excited about their Factor XI program, which they believe is different from competitors' approaches. With two distinct antibodies offering different efficacy and safety profiles, they see potential for multiple indications, considering it a pipeline in itself. -
Next-Generation DUPIXENT Efforts
Q: Are there efforts to develop a next-gen DUPIXENT?
A: The company is constantly working on improving existing products like DUPIXENT and developing entirely new approaches, aiming to improve current treatments and offer next-generation solutions. -
Impact of Avastin Supply Issues
Q: How does the Avastin supply issue affect EYLEA?
A: They are aware of supply issues with Avastin but have not yet seen a material uptake in EYLEA HD or EYLEA. They believe physicians' confidence in EYLEA's clinical profile will position it well if Avastin plays a lesser role. -
Rate of Biosimilar Erosion Comparison
Q: Is Lucentis' biosimilar erosion a proxy for EYLEA's future?
A: Management believes it's too early to compare and that the situation is different due to EYLEA HD's differentiated profile and physicians' experience with EYLEA. They emphasize the significant differences in commercial dynamics. -
Capital Allocation Priorities (Dividend)
Q: Thoughts on share repurchases or dividends?
A: While they discuss capital allocation internally, they have nothing more to add publicly. They consider that the best time to think about a dividend might be after paying off the development balance to Sanofi, expected around the end of 2026.