Savara(US:SVRA)2025-09-09 18:02Summary of Savara FY Conference Call - September 09, 2025 Company Overview - Company: Savara (NasdaqGS:SVRA) - Focus: Single-asset rare disease company targeting rare pulmonary diseases - Key Asset: Mobrevi (morgamostim inhalation solution) for autoimmune pulmonary alveolar proteinosis (autoimmune PAP) [1][2] Core Points and Arguments - Disease Description: Autoimmune PAP is a chronic lung disease caused by GMCSF autoantibodies leading to surfactant accumulation, resulting in symptoms like progressive shortness of breath, chronic cough, and fatigue [2][3] - Current Treatment Landscape: No approved drugs for autoimmune PAP in the U.S. or Europe; the only procedure available is whole lung lavage, which is invasive and does not address the underlying disease [3][4] - Mobrevi Details: - A novel inhaled biologic delivered via a proprietary eFlow nebulizer - Dosage: 300 micrograms inhaled once daily, with a nebulization time of approximately five minutes [4][5] - Clinical Trial Results: - Positive results from the global phase 3 trial (Impala 2) with statistically significant improvements in DLCO (gas exchange measurement) at both 24 and 48 weeks [5][6] - High patient retention with a 100% roll-over into the open-label extension phase [6][7] - Regulatory Timeline: - BLA resubmission in the U.S. expected in December 2025, with potential PDUFA date in August 2026 if priority review is granted [7][8] - MAA submission in the EU and UK planned for Q1 2026, with potential approval in Q1 2027 [8] Market Opportunity - Patient Population: - Revised analysis indicates approximately 5,500 identified autoimmune PAP patients in the U.S., a significant increase from previous estimates [11][12] - Estimated total addressable market in the EU and UK is over 5,000 patients [14] - Pricing Strategy: - Expected annual pricing for Mobrevi in the U.S. is between $400,000 to $500,000 per patient, indicating strong pricing power [10][15] - Market Development Initiatives: - Launch of APAP ClearPath, a no-charge testing program to increase disease awareness and facilitate diagnosis [9][10] Financial Position - Cash Position: As of Q2 2025, Savara reported $146 million on the balance sheet, with guidance indicating cash availability into Q1 2027 [14] - Investor Support: The company is well-covered and has strong investor backing [14][15] Additional Insights - Regulatory Designations: Mobrevi has received orphan drug, fast track, and breakthrough therapy designations in the U.S., along with similar designations in Europe [8] - Long-term Revenue Potential: The combination of regulatory exclusivity, patent prosecution, and a sizable patient population presents a robust opportunity for durable revenue generation upon approval [15]