Summary of Milestone Pharmaceuticals' CARDAMYST FDA Approval Call Company and Product Overview - **Company**: Milestone Pharmaceuticals (NasdaqGS: MIST) - **Product**: CARDAMYST nasal spray - **Indication**: Treatment of Paroxysmal Supraventricular Tachycardia (PSVT) - **FDA Approval Date**: December 15, 2025 - **Market Size**: Over 2 million Americans suffer from PSVT, costing the healthcare system at least $5 billion annually due to emergency visits and hospitalizations [4][22] Key Points and Arguments FDA Approval and Product Significance - CARDAMYST is the first new therapeutic option for PSVT in over 30 years, providing rapid-acting treatment outside healthcare settings [4][11] - The product label received from the FDA met or exceeded expectations, with no major surprises in clinical efficacy and safety data [5][7] - Clinical trials demonstrated that CARDAMYST converts twice as many patients by 30 minutes and three times faster than existing treatments [6][19] Clinical Efficacy and Safety - The primary efficacy endpoint showed a significant p-value at 30 minutes, indicating rapid conversion [5] - Safety profile: Only 0.4% of patients experienced hypotension, and 0.1% experienced syncope, with no significant adverse events reported [7][8] - The product is designed to empower patients to manage their PSVT episodes, reducing reliance on emergency departments [11][19] Commercialization Strategy - The vision for commercial success includes making CARDAMYST easy to use for patients and prescribers, and pricing it to minimize payer restrictions [9][10] - The initial sales force will consist of 60 representatives targeting 10,000 healthcare providers managing 500,000 PSVT patients [24][25] - The wholesale acquisition cost (WAC) is set at $1,649 per prescription, with expected net revenues between $500 and $1,000 [30][57] Market Access and Payer Strategy - Payers are currently not managing PSVT actively, and Milestone aims to secure tier two or three formulary positions with rational pricing [27][29] - The company plans to offer reimbursement support and a copay mitigation program for commercially insured patients [29][30] - The split of patients with PSVT is approximately 45% commercially insured, 45% Medicare, and 10% Medicaid [40] Physician Engagement and Adoption - Physicians have expressed a low barrier to prescribing CARDAMYST due to familiarity with calcium channel blockers [23][26] - The product is expected to be used as an add-on therapy for patients on chronic prophylaxis or as a bridge therapy for those awaiting ablation [26][80] - Early adopters among electrophysiologists are anticipated to drive initial prescriptions, with broader adoption expected over time [61][63] Additional Important Insights - The approval marks a significant transition for Milestone Pharmaceuticals into a commercial organization [34] - The company emphasizes the importance of patient-centric design in the development of CARDAMYST, aiming to alleviate the anxiety associated with PSVT episodes [11][19] - The launch year goals focus on driving provider awareness, trial, and usage, while establishing broad access and affordability [31][32] This summary encapsulates the critical aspects of Milestone Pharmaceuticals' conference call regarding the FDA approval of CARDAMYST, highlighting its significance in the treatment of PSVT, commercialization strategies, and market dynamics.