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Biogen Gets EU Nod for First Postpartum Depression Drug
ZACKSยท 2025-09-18 14:21
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]
Supernus Pharmaceuticals(SUPN) - 2025 FY - Earnings Call Transcript
2025-09-04 13:47
Financial Data and Key Metrics Changes - The company continues to be profitable even through the transition from legacy products to new growth products [4] - KELBRE has shown a 25% growth in prescriptions year-over-year and a 23% growth in the first half of the current year [16] - GOCOVRI has seen a significant increase in patient retention due to Medicare redesign, with 97% of patients having less than $25 co-pay by June [24] Business Line Data and Key Metrics Changes - KELBRE has grown to 35% of the business, with an 80% satisfaction rate among adult users, significantly higher than Strattera's 53% [13] - ZERZUVEY, the first oral treatment for postpartum depression, is expected to set the standard of care, with 80% of women receiving it as a first-line treatment [7] - Anapco, the new infusion device for Parkinson's, is performing well, with demand matching that of AbbVie's product [30] Market Data and Key Metrics Changes - The back-to-school season has shown a 26% growth in the last four-week rolling average for KELBRE, indicating strong momentum [17] - The company has seen a 36% growth in unit shipments of ZERZUVEY quarter-over-quarter, reflecting a healthy brand performance [36] Company Strategy and Development Direction - The acquisition of Sage allows the company to enter women's health while maintaining its CNS focus, indicating a strategic expansion [5] - The company is prioritizing M&A to fill its portfolio with post-Phase II assets, aiming for launches between 2026 and 2030 [58][59] - The company is taking a pause to reevaluate the Sage pipeline while integrating it with its own discovery programs [40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of ZERZUVEY to become the standard of care for postpartum depression [8] - The company anticipates a strong second half of the year, driven by back-to-school momentum and continued growth in its product portfolio [19] - Management is confident that the increased demand from Medicare redesign will offset the mandatory rebates on manufacturers [26] Other Important Information - The company is exploring the potential of its pipeline, particularly focusing on SPN-817 for seizures, which has shown promising results [41] - The company is also considering the future of XERZUVEY and its potential new indications in collaboration with Biogen [39] Q&A Session Summary Question: Can you discuss the acquisition rationale for Sage? - The acquisition allows entry into women's health while maintaining CNS focus, addressing a significant unmet need in postpartum depression [5] Question: What are the expectations for the collaboration with Biogen? - The collaboration is expected to be mutually beneficial, with both companies learning from each other across various functions [10] Question: How is KELBRE performing in the adult ADHD market? - KELBRE has achieved 35% of the business in adults, with an 80% satisfaction rate, indicating strong market acceptance [13] Question: What is the outlook for GOCOVRI following Medicare redesign? - The redesign has improved patient retention, with 97% of patients having low co-pays, which is expected to continue [24] Question: How is Anapco performing compared to AbbVie's product? - Anapco's performance is in line with AbbVie's product, with both addressing a significant need in the market for advanced Parkinson's treatment [30] Question: What is the company's approach to M&A? - The company remains focused on acquiring post-Phase II assets to enhance its portfolio and ensure future growth [58][59]
Supernus Pharmaceuticals (SUPN) 2025 Conference Transcript
2025-09-03 13:02
Summary of Supernus Pharmaceuticals (SUPN) Conference Call Company Overview - Supernus Pharmaceuticals is a CNS-focused biopharmaceutical company with a portfolio of about eight to nine products on the market [2][3] - The company is profitable and has a clean balance sheet, recently completing the acquisition of Sage Therapeutics [2][3] - Supernus has transitioned from the loss of exclusivity on two legacy products and is now in a re-accelerated growth phase driven by key products like Qelbree, Gocovri, Onapgo, and ZURZUVAE [3] Key Products and Market Insights Qelbree (ADHD Treatment) - Qelbree is a novel non-stimulant ADHD medication that works as early as week one, addressing a significant market need for effective non-stimulant options [7][8] - The ADHD market consists of approximately 100 million prescriptions annually, with Supernus currently holding less than 2% market share, indicating substantial growth potential [8][19] - The adult segment represents 67% of the ADHD market, and Supernus has seen growth in this segment, with 35% of their business coming from adults [18][19] - Qelbree has shown a growth rate of 20% plus, with recent data indicating a 25-26% growth during the back-to-school season [18][19] Onapgo (Parkinson's Treatment) - Onapgo is a new continuous infusion device for apomorphine, launched in April, aimed at treating off episodes in Parkinson's patients [23][24] - The device has received positive initial responses, and its market potential is still being evaluated, with estimates ranging from $200 to $300 million [29][30] - The product is designed for advanced patients but may also be used for earlier-stage patients, which could expand its market opportunity [29][30] ZURZUVAE (Postpartum Depression) - ZURZUVAE is the first oral medication approved for postpartum depression (PPD), a condition affecting 1 in 7 women [31] - There is a significant lack of awareness and education regarding PPD, with only about 40% of women diagnosed over the years [31][32] - Supernus is actively working on educating healthcare providers and patients about PPD, emphasizing the importance of screening and diagnosis [32][38] Industry Dynamics and Challenges - The ADHD treatment landscape has historically relied on stimulants, which do not work for 15-30% of patients, creating a demand for effective non-stimulant alternatives [9][10] - In the Parkinson's space, approximately 90-95% of patients experience off episodes after five years of diagnosis, highlighting the need for effective treatments [22][25] - The company is addressing the stigma around ADHD and PPD through influencer partnerships and educational initiatives [21][38] Conclusion - Supernus Pharmaceuticals is positioned for significant growth with its innovative product offerings in ADHD, Parkinson's, and postpartum depression - The company is focused on expanding its market share and improving patient outcomes through education and effective treatment options, indicating a strong potential for future success in the biopharmaceutical industry [3][19][31]