Savara (SVRA) Earnings Call Presentation

MOLBREEVI for aPAP - MOLBREEVI demonstrated statistically significant improvement in DLCO% (primary endpoint) at Week 24 (p=0.0007) and Week 48 (p=0.0008) compared to placebo[37] - MOLBREEVI showed nominally significant improvement in Exercise Capacity (Peak METs) at Week 48 (p=0.0234) compared to placebo[37] - MOLBREEVI significantly reduced pulmonary surfactant burden, as shown by Ground Glass Opacity (GGO) score at Week 24 (p=0.0004)[66] - 100% of patients who completed the double-blind period enrolled into the open-label period[37] - The treatment discontinuation rate in the double-blind period was low at 3%, with none due to drug-related adverse events[37] aPAP Disease and Market - Autoimmune PAP (aPAP) is a rare lung disease with no approved drugs in the U S or Europe, and the only treatment option is an invasive procedure[15] - Analysis of U S claims data identified approximately 3,600 aPAP patients[108] - Market development team of ~25 people will be responsible for profiling accounts to gain line of sight into currently diagnosed patients[117] - U S pulmonologists show overwhelming support for MOLBREEVI, with 83% likely to prescribe it regardless of disease severity[113] - The potential U S market opportunity for aPAP is estimated to be >$1 billion[135] Regulatory and Financial - Savara plans to resubmit the BLA for MOLBREEVI in Q4 2025[31] - The company has ~$172.5 million in cash and short-term investments as of March 31, 2025, and non-dilutive debt financing for up to $200 million[133]