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Can BIIB's New Drugs Revive Growth as Multiple Sclerosis Sales Fall?
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Sales of Biogen’s (BIIB - Free Report) key multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and spinal muscular atrophy (SMA) treatment, Spinraza, are being hurt due to competitive pressure, which is resulting in declining total revenues. Biogen’s total revenues declined 2% in 2024. In 2025, total revenues are expected to decline by a mid-single-digit percentage in constant currency terms.
Biogen believes that some of its new drugs, Eisai-partnered Leqembi for Alzheimer’s disease, Skyclarys for Friedreich’s ataxia and Zurzuvae for depression, have the potential to revive long-term growth. Can Biogen achieve this goal? Let us discuss this in detail.
Key Multiple Sclerosis Drugs, Spinraza Face Increased Competition
Sales of MS drugs and Spinraza are declining due to competitive pressure. Tecfidera revenues are declining as multiple generic versions have been launched in North America, Brazil and certain European countries. Regulatory applications seeking approval for a biosimilar referencing Tysabri have been approved in the United States and Europe. Regulatory applications seeking approval for a biosimilar referencing Tysabri have been approved in both the United States and Europe. A Tysabri biosimilar is now available in some European countries and this is hurting growth. Additional launches in other EU countries and in the United States are expected in 2025.
Biogen’s global MS revenues declined 7% in 2024. The decline in MS revenues is expected to be steeper in 2025 than in 2024 due to the potential biosimilar entry of Tysabri in the United States this year and the potential generic entry of Tecfidera in some European markets.
Spinraza sales declined almost 10% in 2024 due to increased competitive pressure and a decrease in demand. Spinraza’s demand trends are not expected to improve much in 2025.
Other than competitive pressure on MS drugs and Spinraza, Biogen’s other troubles include the FDA approval of Eli Lilly’s (LLY - Free Report) Alzheimer’s drug Kisunla (donanemab) in July 2024, which poses significant competition to Leqembi. Biogen faced several pipeline setbacks in 2024. In November, Biogen and partner Sage Therapeutics (SAGE - Free Report) discontinued further development of Zurzuvae in major depressive disorder indication, which represented a much larger market opportunity than the currently approved postpartum depression (PPD) indication.
Foreign exchange headwinds are expected to hurt 2025 revenues by 1%, while the negative impact of the Medicare Part D redesign is expected to be between approximately $50 million and $100 million. Roughly one-third of the negative impact of the Medicare Part D redesign is expected to be related to Skyclarys, with the balance coming from MS drugs.
BIIB’s New Drug Contributing to Top-Line Growth: Is it Enough?
Biogen and partner Eisai’s Leqembi/lecanemab gained full approval from the FDA for early Alzheimer’s disease in the United States in July 2023. Though the Leqembi launch was slow, it picked up in 2024, showing sequential improvement. The positive trend is expected to continue in 2025.
Biogen believes it has the potential to generate blockbuster sales as there remains a massive unmet need for Alzheimer's disease. Regulatory applications seeking approval of Leqembi are under review in Europe. Leqembi has been launched in China and Japan. A less frequent maintenance intravenous dosing version of Leqembi was approved by the FDA in January 2025. A regulatory application for the subcutaneous autoinjector is under review, with a decision from the FDA expected on Aug. 31, 2025. Biogen and Eisai believe that the introduction of blood-based diagnostics (which can help earlier detection of Alzheimer’s) and subcutaneous autoinjector for maintenance and initiation (expected to be launched in 2026) should drive Leqembi’s growth.
Biogen and partner Sage’s Zurzuvae (zuranolone) was approved by the FDA to treat women with PPD in August 2023. The acquisition of Reata Pharmaceuticals in September 2023 added its newly approved rare disease drug, Skyclarys, for the treatment of Friedreich’s ataxia to Biogen’s portfolio. Skyclarys is seeing strong launch trends in the United States as well as EU, with ex-U.S. sales expected to be a more important driver of growth in 2025. Zurzuvae’s launch also exceeded the company’s internal expectations.
However, the new drugs are not generating enough sales yet to make up for the declining revenues of MS drugs and Spinraza. Unfavorable channel inventory and some Medicare discount dynamics hurt Skyclarys’ sales in the United States in the fourth quarter. It remains to be seen if the negative impact continues in 2025.
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Can BIIB's New Drugs Revive Growth as Multiple Sclerosis Sales Fall?
Sales of Biogen’s (BIIB - Free Report) key multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and spinal muscular atrophy (SMA) treatment, Spinraza, are being hurt due to competitive pressure, which is resulting in declining total revenues. Biogen’s total revenues declined 2% in 2024. In 2025, total revenues are expected to decline by a mid-single-digit percentage in constant currency terms.
Biogen believes that some of its new drugs, Eisai-partnered Leqembi for Alzheimer’s disease, Skyclarys for Friedreich’s ataxia and Zurzuvae for depression, have the potential to revive long-term growth. Can Biogen achieve this goal? Let us discuss this in detail.
Key Multiple Sclerosis Drugs, Spinraza Face Increased Competition
Sales of MS drugs and Spinraza are declining due to competitive pressure. Tecfidera revenues are declining as multiple generic versions have been launched in North America, Brazil and certain European countries. Regulatory applications seeking approval for a biosimilar referencing Tysabri have been approved in the United States and Europe. Regulatory applications seeking approval for a biosimilar referencing Tysabri have been approved in both the United States and Europe. A Tysabri biosimilar is now available in some European countries and this is hurting growth. Additional launches in other EU countries and in the United States are expected in 2025.
Biogen’s global MS revenues declined 7% in 2024. The decline in MS revenues is expected to be steeper in 2025 than in 2024 due to the potential biosimilar entry of Tysabri in the United States this year and the potential generic entry of Tecfidera in some European markets.
Spinraza sales declined almost 10% in 2024 due to increased competitive pressure and a decrease in demand. Spinraza’s demand trends are not expected to improve much in 2025.
Other than competitive pressure on MS drugs and Spinraza, Biogen’s other troubles include the FDA approval of Eli Lilly’s (LLY - Free Report) Alzheimer’s drug Kisunla (donanemab) in July 2024, which poses significant competition to Leqembi. Biogen faced several pipeline setbacks in 2024. In November, Biogen and partner Sage Therapeutics (SAGE - Free Report) discontinued further development of Zurzuvae in major depressive disorder indication, which represented a much larger market opportunity than the currently approved postpartum depression (PPD) indication.
Foreign exchange headwinds are expected to hurt 2025 revenues by 1%, while the negative impact of the Medicare Part D redesign is expected to be between approximately $50 million and $100 million. Roughly one-third of the negative impact of the Medicare Part D redesign is expected to be related to Skyclarys, with the balance coming from MS drugs.
BIIB’s New Drug Contributing to Top-Line Growth: Is it Enough?
Biogen and partner Eisai’s Leqembi/lecanemab gained full approval from the FDA for early Alzheimer’s disease in the United States in July 2023. Though the Leqembi launch was slow, it picked up in 2024, showing sequential improvement. The positive trend is expected to continue in 2025.
Biogen believes it has the potential to generate blockbuster sales as there remains a massive unmet need for Alzheimer's disease. Regulatory applications seeking approval of Leqembi are under review in Europe. Leqembi has been launched in China and Japan. A less frequent maintenance intravenous dosing version of Leqembi was approved by the FDA in January 2025. A regulatory application for the subcutaneous autoinjector is under review, with a decision from the FDA expected on Aug. 31, 2025. Biogen and Eisai believe that the introduction of blood-based diagnostics (which can help earlier detection of Alzheimer’s) and subcutaneous autoinjector for maintenance and initiation (expected to be launched in 2026) should drive Leqembi’s growth.
Biogen and partner Sage’s Zurzuvae (zuranolone) was approved by the FDA to treat women with PPD in August 2023. The acquisition of Reata Pharmaceuticals in September 2023 added its newly approved rare disease drug, Skyclarys, for the treatment of Friedreich’s ataxia to Biogen’s portfolio. Skyclarys is seeing strong launch trends in the United States as well as EU, with ex-U.S. sales expected to be a more important driver of growth in 2025. Zurzuvae’s launch also exceeded the company’s internal expectations.
However, the new drugs are not generating enough sales yet to make up for the declining revenues of MS drugs and Spinraza. Unfavorable channel inventory and some Medicare discount dynamics hurt Skyclarys’ sales in the United States in the fourth quarter. It remains to be seen if the negative impact continues in 2025.