Savara(US:SVRA)2026-02-11 18:32Summary of Savara's Conference Call Company Overview - Company: Savara - Focus: Single asset company specializing in orphan rare pulmonary diseases - Key Asset: MOLBREEVI, targeting autoimmune pulmonary alveolar proteinosis (APAP) [3][4] Core Points and Arguments - Regulatory Progress: - Resubmitted Biologics License Application (BLA) for MOLBREEVI in December, expecting FDA acceptance soon [3][4] - Anticipates priority review due to Breakthrough Therapy Designation, with PDUFA date projected for August [4] - Plans to file Marketing Authorization Applications (MAAs) in Europe and the UK by the end of Q1 [4] - Manufacturing Changes: - Shifted to Fujifilm as the primary drug substance manufacturer after a refusal to file due to manufacturing data issues [5][6] - Alignment achieved with FDA on analytical comparability protocol with Fujifilm [6][8] - Clinical Data: - Strong Phase 3 results published in the New England Journal, with DLCO as the primary endpoint showing statistical significance at 24 weeks [9][10] - Key secondary endpoints also demonstrated clinical benefit, including SGRQ and exercise tolerance tests [10][11] - Market Potential: - Identified approximately 5,500 diagnosed patients in the U.S., with a goal to confirm 1,000 patients by the end of 2025 [18][19] - Market is concentrated, with top 500 accounts representing about two-thirds of the market [19][20] - Commercial Strategy: - Partnering with PANTHERx, a specialty pharmacy, to facilitate product launch and patient access [21] - Ongoing disease awareness campaigns targeting both physicians and patients to increase diagnosis and treatment uptake [24][25] - Pricing Strategy: - Pricing corridor established between $400,000 and $500,000 per patient per year, with payers showing willingness to cover under typical prior authorization criteria [32] - International Plans: - Plans to commercialize in Europe and the UK independently, with a similar market opportunity as the U.S. [33] - Japan's market strategy remains under evaluation, with potential differences in approach compared to Europe and the UK [35] Additional Important Information - Patient Awareness: - Disease awareness campaigns have successfully identified newly diagnosed patients, indicating a potential for higher prevalence than previously estimated [25][27] - Financial Position: - Well-funded with $264 million on the balance sheet and potential for $75 million in royalties upon FDA approval [39] - Restructured debt facility allows for up to $150 million in non-dilutive capital upon FDA approval [39] - Upcoming Catalysts: - Anticipated updates regarding FDA decision by the end of January, with a focus on maintaining communication with stakeholders [38]