Biogen FY Conference Summary Company Overview - **Company**: Biogen (NasdaqGS:BIIB) - **Date of Conference**: September 24, 2025 Key Points Alzheimer's Disease and LEQEMBI - Biogen is experiencing positive momentum with the launch of LEQEMBI, particularly following the approval for subcutaneous maintenance therapy, which offers patients the option to self-administer at home [2][10] - The company is also pursuing a rolling submission for subcutaneous initiation therapy, expected to provide patients with more treatment options [2][10] - The approval of blood-based biomarkers by the FDA is seen as a significant advancement, increasing testing and potentially improving patient outcomes [3] Revenue Growth and R&D Focus - Year-on-year revenue growth from new products is offsetting declines from multiple sclerosis (MS) products, indicating a strategic shift towards growth products [4] - Biogen is focusing on high-value, high-probability success programs in its R&D pipeline, with several late-stage programs expected to yield registrational data soon [4][5] Pipeline Developments - Biogen is advancing several programs into Phase 3 trials, including treatments for lupus and rare nephrology conditions [5][6] - The company is also exploring new modalities and collaborations, such as with Stoke Therapeutics for Dravet syndrome [6][7] TAU ASO and CELIA Study - The TAU ASO (BIIB080) is in Phase 2 trials, with hopes to demonstrate significant reductions in TAU levels and clinical benefits [11][12] - The CELIA study aims to evaluate the impact of reducing all TAU isoforms on biomarkers and clinical outcomes [12] GLP-1 and Alzheimer's - Biogen acknowledges the potential of GLP-1 therapies in addressing neuroinflammatory pathways in Alzheimer's, despite mixed results from other trials [15] AHEAD Trials - The AHEAD 3 and AHEAD 4, 5 trials are designed to address pre-symptomatic stages of Alzheimer's, focusing on preventing further amyloid accumulation and cognitive decline [17][18] SMA and SPINRAZA - Biogen continues to focus on spinal muscular atrophy (SMA) with SPINRAZA, which remains a critical therapy despite competition from gene therapies [22][23] - The company is pursuing a high-dose version of SPINRAZA and a new antisense oligonucleotide, Salinursin, with promising early data [24][25] Lupus Opportunities - Lupus is identified as a significant market opportunity, with only two biologics currently available and a high unmet need [27][28] - Biogen is advancing Dapirolizumab pegol and litifilimab through multiple Phase 3 trials, targeting different lupus manifestations [29][30] Felsardimab and Rare Kidney Indications - Felsardimab is being explored for several rare kidney conditions, with ongoing Phase 3 trials and a focus on addressing unmet needs in these areas [39][40] - The company is optimistic about the potential of Felsardimab in conditions like AMR and IgAN, despite a crowded competitive landscape [41][42] IRAK4 Program - The IRAK4 program is in early development stages, with plans for a Phase 2 program to explore its potential in various inflammatory conditions [48] Overall R&D Strategy - Biogen's R&D strategy emphasizes a diversified pipeline with multiple high-value programs, aiming for significant market impact across various therapeutic areas [50] - The company is committed to innovation and disciplined cost management while expanding its portfolio through both internal and external collaborations [50] Conclusion - Biogen is positioned for growth with a robust pipeline across neurology, immunology, and rare diseases, focusing on high unmet needs and innovative therapies [50]

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. announced the approval of LEQEMBI (lecanemab) by the Therapeutic Goods Administration (TGA) of Australia for treating mild cognitive impairment or mild dementia due to Alzheimer's disease in specific adult populations [1][2]. Group 1: Product Approval and Clinical Data - The approval of LEQEMBI was based on Phase 3 data from the Clarity AD clinical trial, which demonstrated a 33% reduction in clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale at 18 months compared to placebo [9]. - The Clarity AD trial involved 1,795 patients with early Alzheimer's disease, with 1,521 patients in the Australian indicated population [9]. - LEQEMBI has been approved in 50 countries and is under regulatory review in 8 countries, with significant results from the global Clarity AD clinical trial [8]. Group 2: Alzheimer's Disease Context - In Australia, the number of people living with dementia is estimated to rise from approximately 425,000 in 2024 to nearly 1,100,000 by 2065, with Alzheimer's disease accounting for 60-70% of dementia cases [3]. - Alzheimer's disease is characterized by a progressive neurotoxic process involving amyloid beta (Aβ) and tau, with LEQEMBI targeting both toxic protofibrils and amyloid plaques [3][8]. Group 3: Collaboration and Development - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing and co-promoting the product [4][12]. - Eisai and BioArctic have collaborated since 2005 on the development and commercialization of Alzheimer's disease treatments, with Eisai obtaining global rights for lecanemab in 2007 [13].

Core Insights - Biogen's request for supplemental marketing authorization for a higher dose of Spinraza has been declined by the U.S. FDA, indicating regulatory challenges for the company in expanding its treatment options for spinal muscular atrophy [5] Company Summary - The FDA's complete response letter to Biogen highlighted that the company needs to address specific concerns before any further consideration of the higher dose of Spinraza can occur [5]

Core Viewpoint - The U.S. Food and Drug Administration (FDA) has rejected the approval of a higher dose version of Biogen's drug aimed at treating a rare genetic disorder that leads to progressive muscle weakness, representing a significant setback for the company [1] Company Summary - Biogen's drug was intended to address a rare genetic disorder, but the FDA's decision indicates challenges in gaining regulatory approval for higher dosage formulations [1] - The rejection may impact Biogen's market position and future revenue projections related to this specific treatment [1] Industry Summary - The FDA's decision highlights the regulatory hurdles faced by pharmaceutical companies in bringing new treatments to market, particularly for rare diseases [1] - This event may influence investor sentiment and market dynamics within the biotech sector, especially for companies developing similar therapies [1]

Core Viewpoint - Biogen Inc. received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for a high dose regimen of nusinersen for spinal muscular atrophy (SMA), requesting updates to the technical information in the Chemistry Manufacturing and Controls (CMC) module [1][2] Group 1: FDA Response and Company Actions - The FDA's letter did not indicate any deficiencies in the clinical data for the high dose regimen [2] - Biogen plans to promptly resubmit the application based on readily available information [2] - The company is collaborating with global regulatory authorities to advance the high dose regimen as an additional option for SMA patients [2] Group 2: Product Information - SPINRAZA (nusinersen) is approved in over 71 countries for treating SMA in infants, children, and adults, with more than 14,000 individuals treated worldwide [3] - The drug has demonstrated efficacy across various ages and SMA types, supported by a well-established safety profile from data in patients treated for up to 10 years [4] Group 3: Company Background - Biogen, founded in 1978, is a leading biotechnology company focused on innovative science to develop new medicines and create value for shareholders and communities [6]

Group 1 - Biogen Inc. shares are currently trading at $145.60, reflecting a 0.50% increase in the current session, with a 4.28% rise over the past month, but a decline of 27.23% over the past year [1] - The P/E ratio is a critical metric for long-term shareholders to evaluate the company's market performance against historical earnings and industry standards [5] - Biogen's P/E ratio stands at 13.86, which is significantly lower than the biotechnology industry's aggregate P/E ratio of 29.8, suggesting potential undervaluation or weaker future performance expectations [6] Group 2 - A low P/E ratio can indicate undervaluation but may also reflect weak growth prospects or financial instability, necessitating cautious interpretation [9] - The P/E ratio should be considered alongside other financial metrics, industry trends, and qualitative factors for a comprehensive analysis of the company's financial health [9]

Core Insights - Biogen's Zurzuvae (zuranolone) has received approval from the European Commission for the treatment of postpartum depression (PPD) in adults, making it the first and only approved treatment for this indication in the European Union [1][7] - The approval is based on the successful phase III SKYLARK study, which demonstrated rapid and sustained relief from depressive symptoms [2][7] - Biogen's stock has underperformed this year, with a 5% decline compared to a 3% growth in the industry [3] Product Performance - Zurzuvae was launched in the United States in December 2023, and sales reached $46.4 million in Q2 2025, reflecting a 68% increase sequentially due to rising demand [6][7] - The drug's launch exceeded Biogen's internal expectations, indicating strong market acceptance [6][7] Strategic Partnerships - Zurzuvae was developed in collaboration with Sage Therapeutics, which has been acquired by Supernus Pharmaceuticals. Biogen and Supernus share profits and losses from the commercialization of Zurzuvae in the U.S. [5] Future Growth Potential - Zurzuvae is one of four new product launches by Biogen, alongside Leqembi for Alzheimer's disease, Skyclarys for Friedreich's Ataxia, and Qalsody for ALS, which are expected to drive long-term growth [8]

Core Viewpoint - Biogen (BIIB.US) has agreed to acquire Alcyone Therapeutics, expanding its drug delivery solutions portfolio for key products and pipeline candidates [1] Group 1: Acquisition Details - The acquisition includes an upfront payment of $85 million and additional milestone payments related to the development and regulatory approval of ThecaFlex DRx [1] - Biogen will gain full rights to ThecaFlex DRx, an experimental implantable device for intrathecal delivery of antisense oligonucleotides (ASO) [1] Group 2: Product Development - Biogen plans to drive end-to-end research and commercialization of ThecaFlex DRx, which aims to provide a new convenient delivery method for patients with neurological diseases [1] - The ThecaFlex DRx system is currently undergoing clinical testing in conjunction with Spinraza (nusinersen) for patients with spinal muscular atrophy, which will provide important guidance for Biogen's future experimental therapies [1] Group 3: Integration and Team Enhancement - Following the completion of the transaction, Alcyone employees will be integrated into Biogen's product delivery solutions team, enhancing the company's capabilities in drug-device combination products [1]

Group 1 - Biogen has agreed to acquire Alcyone Therapeutics for an upfront payment of $85 million [5] - The acquisition includes additional milestone payments linked to the development and regulatory approval of ThecaFlex DRx [5]

Core Viewpoint - Biogen Inc. has entered into a definitive agreement to acquire Alcyone Therapeutics, focusing on the development of ThecaFlex DRx™, an implantable device for the intrathecal delivery of antisense oligonucleotides (ASOs) aimed at improving patient experience for those with neurological disorders [1][2][3]. Company Overview - Biogen is a leading biotechnology company founded in 1978, specializing in innovative science to deliver new medicines and create value for shareholders and communities [13]. - Alcyone Therapeutics is a clinical-stage biotechnology company focused on precision CNS therapeutics and has been collaborating with Biogen since 2023 [15]. Acquisition Details - Biogen will acquire Alcyone Therapeutics for an upfront cash payment of $85 million, with additional milestone payments related to the development and regulatory approval of ThecaFlex DRx™ [5]. - The acquisition will allow Biogen to oversee the end-to-end development, manufacturing, and commercialization of ThecaFlex DRx™, while Alcyone's remaining assets will be divested into a new independent company, Neela Therapeutics, Inc. [6]. Product Development - ThecaFlex DRx™ is designed to provide an alternative to repeated lumbar punctures for chronic intrathecal administration of medicines, potentially easing patient experience and accessibility [1][8]. - The device has received a CE Mark in Europe and an Investigational Device Exemption (IDE) from the FDA, but has not yet been approved for commercial use in the U.S. [8]. Clinical Studies - ThecaFlex DRx™ is currently being evaluated with SPINRAZA® (nusinersen) in clinical studies for spinal muscular atrophy (SMA), which will inform pathways for Biogen's broader portfolio of investigational therapies [2][3]. - SPINRAZA is already approved in over 71 countries and has treated more than 14,000 individuals worldwide [9]. Strategic Importance - The acquisition is seen as a strategic opportunity for Biogen to expand its capabilities and enhance the value proposition of its medicines by providing a patient-centered solution [3]. - Biogen's expertise in ASOs and drug delivery innovations positions it as an ideal partner to advance ThecaFlex DRx™ technology [3].