Biogen Inc (BIIB) Q1 2025 Earnings Call Highlights: Strong Revenue Growth Amidst MS Franchise ...

GuruFocus.com
02 May
  • Total Revenue: $2.4 billion, up 6% year-over-year.
  • Non-GAAP Diluted EPS: $3.02, down 18% year-over-year; adjusted EPS would have been $3.97, up 8% year-over-year excluding a $165 million charge.
  • Free Cash Flow: $222 million, including a $165 million upfront payment to Stoke.
  • Cash Position: $2.6 billion at the end of the quarter.
  • MS Franchise Revenue Decline: 11% year-over-year, primarily due to competition.
  • LEQEMBI Sales: $96 million, up approximately 11% sequentially.
  • SKYCLARYS Revenue: $124 million, up 59% year-over-year and 21% quarter-on-quarter.
  • ZURZUVAE Sales: $28 million in Q1.
  • VUMERITY Demand Increase: Remains the number 1 branded oral therapy.
  • Guidance for 2025: Non-GAAP diluted EPS expected between $14.50 and $15.50; total revenue expected to decline by a mid-single-digit percentage.
  • Warning! GuruFocus has detected 6 Warning Signs with BIIB.

Release Date: May 01, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Biogen Inc (NASDAQ:BIIB) reported a strong start to the year with a significant increase in revenue from new product launches, contributing to 45% of product revenue.
  • The company received FDA Fast Track designation for its ASO targeting BIIB080, indicating confidence in its potential for Alzheimer's treatment.
  • LEQEMBI received marketing authorization in the EU, marking a significant regulatory endorsement for its efficacy and safety profile.
  • Biogen Inc (NASDAQ:BIIB) has a robust pipeline with five Phase III studies initiating this year, indicating a maturation of its pipeline.
  • The company maintains a strong balance sheet, allowing for continued investment in internal and external growth opportunities.

Negative Points

  • Biogen Inc (NASDAQ:BIIB) faces declining revenue in its MS franchise due to competition from biosimilars and generics.
  • The launch of LEQEMBI has been challenging due to the workload it imposes on treating physicians.
  • The company anticipates a mid-single-digit percentage decline in total revenue for 2025, primarily driven by a decline in the MS business.
  • Biogen Inc (NASDAQ:BIIB) is experiencing impacts from the Medicare tax, affecting net sales growth.
  • The tariff landscape remains uncertain, posing potential risks to the company's financial outlook.

Q & A Highlights

Q: Congrats on the recent LEQEMBI approval in Europe. Can you talk about what the rollout strategy could look like there and your sense of what the reimbursement process and amenability could be? A: The rollout strategy in Europe will take some time due to the complexity of launching a first-in-class, disease-modifying agent. These products are incremental adds to the healthcare budget, making the process more challenging. However, the thorough examination by the EMA should aid in reimbursement discussions. We will approach this market by market with our partners, Eisai, focusing on expanding in Europe's aging population.

Q: I wanted to touch again on LEQEMBI, but this time with the subcutaneous formulation. Maybe remind us how that potential for at-home administration can help accelerate sales in the United States. A: The subcutaneous formulation for maintenance will simplify the treatment process for patients who have been undergoing biweekly infusions for 18 months. It will make long-term therapy more patient-friendly, potentially increasing adherence. In rural settings, subcutaneous administration might be preferred from the start, reducing the burden on infusion centers and caregivers.

Q: Could you speak to your thoughts on LEQEMBI uptick in growth on the forward, not only with subcutaneous maintenance dosing in the second half but also with Fujirebio's in-vitro diagnostic? A: The in-vitro diagnostic could facilitate earlier diagnosis and treatment, which is crucial for Alzheimer's patients. Early diagnosis allows for treatment before significant neuronal damage occurs. The diagnostic's approval and reimbursement processes are different from drugs, but they are expected to support the urgency of treating symptomatic early AD patients.

Q: On LEQEMBI, how are you seeing the market parse out between your product and Lilly's Kisunla? A: The market will likely split between LEQEMBI and Donanemab, depending on physician and patient preferences. Some physicians may prefer a finite dosing approach, while others will focus on long-term maintenance. The key is expanding the market to treat more patients, as both products have shown efficacy in treating Alzheimer's.

Q: I just would love a bit more elaboration on latest thoughts on business development in terms of the size and scopes of deals you're considering. A: The current market environment presents opportunities for business development, particularly as some companies face financing challenges. Biogen is well-positioned to engage in collaborations, especially in early research, due to our biotech roots and established West Coast hub. We remain disciplined in evaluating potential deals to ensure they align with our strategic goals.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.

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