Disc Medicine(US:IRON)2026-01-15 00:02Summary of Disc Medicine Conference Call Company Overview - Company: Disc Medicine - Focus: Red blood cell biology, specifically manipulating heme and iron metabolism to address various diseases, including rare and common anemias [3][4] Core Programs - Lead Program: Bitopertin for Erythropoietic Protoporphyria (EPP) - Patient Population: Estimated 14,000 patients in the U.S. with EPP [6] - NDA Status: Submitted and under accelerated review, with anticipated approval by late January or early February [7][14] - Clinical Data: - Reduction of protoporphyrin IX (PP-9) by 50%-60% in trials [10] - 75% reduction in phototoxic reactions in the Aurora study [12] - High patient satisfaction with reported improvements in disease state [13] - Pipeline Programs: - DISC-0974: Targets hemojuvelin, in late-stage Phase 2 development for myelofibrosis anemia [7][26] - DISC-3405: Targets TMPRSS6, designed to restrict iron for conditions like polycythemia vera and sickle cell disease [8][38] Market Opportunities - EPP Market: Potential market size of over $2 billion if all diagnosed patients are treated [46] - Myelofibrosis Anemia: Estimated 25,000 patients in the U.S., with a potential market exceeding $4 billion [29][47] - Polycythemia Vera: Approximately 75,000 patients, with significant unmet needs and potential for iron restriction therapy [39][40] Launch Strategy - Sales Team: 24 representatives ready for launch, focusing on top 120 accounts [19][22] - Patient Engagement: Strategies to identify and engage the 8,000 patients who are currently undiagnosed or untreated [48][49] - Payer Mix: Favorable payer landscape with 16% commercial, 25% Medicare, and 15% Medicaid [25] Regulatory and Clinical Milestones - Upcoming Milestones: - Anticipated FDA action date for bitopertin in late January or early February [46] - Top-line data from the confirmatory Apollo trial expected by late this year or early next year [15][43] - Plans to initiate pivotal trials for myelofibrosis and polycythemia vera in 2027 [42][44] Financial Position - Capital: Approximately $791 million available, providing runway into 2029 without assuming revenue from bitopertin [44][45] Conclusion - Disc Medicine is positioned for a significant year with the potential approval of bitopertin and a robust pipeline addressing critical unmet needs in hematology-oncology, with a strong financial foundation to support its growth strategy [46][47]