Biogen Inc. Q3 FY2025 earnings call

Management Statement and Operational Highlights:

• Launch Products: Strong growth seen in LEQEMBI, SKYCLARYS, and ZURZUVAE. LEQEMBI has sustained global demand growth, SKYCLARYS is available in 34 markets, and ZURZUVAE is driving significant revenue growth.
• Pipeline Progress: Litifilimab Phase III studies fully enrolled with expected readouts in H2 2026. BIIB142 Phase I study started for an IRAK4 degrader. Acquired Alcyone Therapeutics for ASO technology and licensed with Vanqua Bio for a C5aR1 antagonist.
• Commercial Execution: LEQEMBI's subcu maintenance launched with positive feedback. SKYCLARYS expanding globally, and ZURZUVAE's growth driven by increased demand.
• Efficiency: On track to deliver $1 billion gross savings, managing R&D and OpEx efficiently while growing the business.

Segment Performance:

• LEQEMBI: Global sales of $121 million in Q3 with strong sequential demand growth. Year-to-date, it has helped offset MS decline.
• SKYCLARYS: 30% year-over-year revenue growth, available in 34 markets globally.
• ZURZUVAE: 150% year-over-year revenue growth, revolutionizing perception of postpartum depression.
• MS Products: VUMERITY had ~$0.5 billion sales in the first 9 months of the year. TECFIDERA faces generic erosion in Europe, while TYSABRI's subcutaneous formulation grows, accounting for over 50% of branded and biosimilar natalizumab patients in Europe. SPINRAZA has consistent global demand, with ex-US impacted by inventory drawdown.

Guidance:

• Updated non-GAAP EPS guidance reflects a stronger business outlook.
• Sales expected to be flat to up 1% at constant currency.
• Competitive pressures on ex-US MS business, particularly TECFIDERA in Europe, expected to accelerate.
• Investments in pipeline expansion, prelaunch activities for late-stage pipeline, and direct-to-consumer advertising for launch products.

Risks:

• Generic erosion of TECFIDERA in Europe.
• Uncertainty in clinical trial outcomes for late-stage pipeline products.
• Challenges in market adoption and pricing of new products, including subcu formulations of LEQEMBI.

Q: How does the EVOKE trial impact the LEQEMBI franchise and portfolio offering?

A: Christopher Viehbacher noted to see trial results, if positive, may increase use in primary care; Priya Singhal emphasized neuroinflammation hypothesis and importance of disease awareness.

Q: Talk about immunology focus driving growth and pipeline expansion.

A: Christopher Viehbacher stated Biogen has always been in immunology, with experience in MS applicable to lupus, and plans to build immunology portfolio via BD.

Q: Early experience with LEQEMBI subcu maintenance uptake and access?

A: Alisha Alaimo said feedback positive, gradual uptake expected, working on non-formulary exemptions and Medicare Part D access.

Q: SKYCLARYS volume growth and reimbursement issues?

A: Alisha Alaimo mentioned ex-US growth, US impacted by channel mix, discon rates improved with education.

Q: Tau Phase II data and regulatory pathway?

A: Priya Singhal said need to see biomarker and clinical benefit impact, stepwise approach to portfolio if positive.

Q: Capital allocation balancing BD and new launches?

A: Christopher Viehbacher said focusing on long-term growth, efficient capital use, and disciplined BD to drive shareholder value.