Idorsia (OTCPK:IDRS.F) FY Conference Transcript

Summary of Idorsia Conference Call Company Overview - Company Name: Idorsia - Founded: 2017, following the acquisition of Actelion by Johnson & Johnson - Pipeline History: The R&D pipeline dates back to 1997, with a legacy team from Actelion [3][4] Core Products and Pipeline - Approved Products: - Clazosentan: Approved in Asia for subarachnoid hemorrhage - Daridorexant (QUVIVIQ): Approved for insomnia disorder, available in 13 countries - Aprocitentan (Tryvio/Jeraygo): Approved for resistant hypertension in the US and Europe - Phase Three Assets: Three assets, two partnered with Viatris, and one (Lucerastat) for Fabry disease [4][5] Product Performance - QUVIVIQ: - Launched in 2023, recognized as best-in-class among dual orexin receptor antagonists (DORAs) due to its design and pharmacokinetics (80% clearance within 8 hours) [6][11] - Initially led in new prescriptions (NBRX) but faced challenges in the US market due to competition and payer negotiations [11][13] - Sales in Europe are strong, with expectations to reach CHF 130 million in 2025, doubling from the previous year [40][41] Market Challenges - Payer Positioning: Difficulty in negotiating payer positions as a late entrant in the DORA class, with commercial insurers favoring cheaper alternatives like trazodone and benzodiazepines [13][15] - Regulatory Status: QUVIVIQ is currently a Schedule IV product, impacting prescriber and pharmacy access. A class-wide descheduling application is in process [21][30] Future Outlook - Revenue Projections: Expected revenues of CHF 210 million to CHF 270 million over the next two years, contingent on reimbursement negotiations and expanding prescriber base [40][41] - Clinical Development: Active programs for both orexin antagonists and agonists, with an orexin agonist approaching phase one [36][39] - Aprocitentan: Approved but not yet launched; seeking partnerships to facilitate market entry [52][54] Additional Insights - Research and Development: Ongoing studies for QUVIVIQ in patients with psychiatric disorders, anxiety, and other comorbidities to broaden its prescriber base [42][43] - Partnerships: Excitement around partnerships with Viatris for innovative products like Selatogrel and Lupus programs, with milestone and royalty economics [44][45] - Renal Safety Profile: Aprocitentan shows a distinctive renal safety profile, making it suitable for patients with chronic kidney disease [55] Upcoming Clinical Events - Pediatric Daridorexant Study: Phase two readout expected in early 2026, targeting pediatric insomnia, including special populations like children with autism and ADHD [66][69] This summary encapsulates the key points discussed during the conference call, highlighting Idorsia's product pipeline, market challenges, and future outlook.