Omeros(OMER) - 2024 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The net loss for Q3 2024 was $32.2 million or$0.56 per share, a decrease from a net loss of $56 million or$0.97 per share in Q2 2024, primarily due to a $17.6 million expense related to narsoplimab in Q2 [7][49] - Cash and investments as of September 30, 2024, totaled$123.2 million, a decrease of $35.8 million from June 30, 2024 [8][49] - Operating costs from continuing operations for Q3 were$35.4 million, down 23.8 million from Q2, driven by reduced R&D expenses [49] Business Line Data and Key Metrics Changes - OMIDRIA royalties for Q3 were 9.3 million, with net sales of $31 million, compared to royalties of$10.9 million and net sales of $36.4 million in Q2, indicating a decrease in both metrics [54] - The company expects to initiate HOPD sales for OMIDRIA starting January 1, 2025, which is anticipated to significantly increase sales in the U.S. [9][10] Market Data and Key Metrics Changes - The market size for PNH is reported to be$3.9 billion in 2023 and projected to exceed $10 billion by 2032, indicating a growing opportunity for zaltenibart [32] Company Strategy and Development Direction - The company is focused on the resubmission of the Biologics License Application (BLA) for narsoplimab in TA-TMA, with expectations for a quick turnaround following FDA feedback [11][15] - Omeros is advancing its zaltenibart program with plans for Phase 3 trials in PNH and C3G, with a clear path established through discussions with FDA and European regulators [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for commercial sales of narsoplimab in 2025, contingent on successful BLA resubmission [60] - The company is preparing for the initiation of Phase 3 trials for zaltenibart, with a focus on patient enrollment and leveraging previous positive data [75] Other Important Information - The FDA has established a rare disease innovation hub to facilitate the development of treatments for rare diseases, which may benefit Omeros' programs [17] - The company is also exploring additional indications for its MASP-3 inhibitor, zaltenibart, and has received a rare pediatric disease designation for C3G [33][34] Q&A Session Summary Question: Expectations for narsoplimab commercial sales - Management hopes to have narsoplimab commercially available in 2025, pending alignment on the statistical analysis plan with the FDA [60] Question: Phase 3 trial designs for zaltenibart - The Phase 3 trials will include a switch-over trial for patients not responding to ravulizumab and a trial for treatment-naive patients, with positive feedback received from regulatory agencies [66][68] Question: Strategy for the priority review voucher for pediatric C3G - Management indicated it is premature to discuss strategy regarding the voucher, considering market interest and potential internal use [69] Question: Size and cost estimates for OMS906 Phase 3 program - The Phase 3 studies are expected to be relatively small, with around 100 patients per trial, and management is confident in moving forward independently while exploring partnership opportunities [74][75]