Iterum Therapeutics(ITRM) - 2022 Q3 - Earnings Call Presentation

Sulopenem Development and Clinical Trials - Iterum is developing sulopenem, an oral and IV penem antibiotic, for serious bacterial infections[1] - Oral sulopenem demonstrated superiority to ciprofloxacin in uUTI patients with quinolone non-susceptible pathogens (p-value < 0001)[5] - Iterum is conducting an additional Phase 3 clinical trial in uUTI under SPA agreement with the FDA, with topline data expected in the first half of 2024[6] - Over 3,700 patients have been enrolled in Phase 3 studies, with over 1,800 treated with sulopenem[21] Market Opportunity and Commercialization - Approximately 33 million annual prescriptions (TRx) are written for uUTIs in the US, with an estimated addressable market for sulopenem > 10 million TRxs[10] - The three leading uUTI antibiotics have an estimated market share of ~75% but each demonstrates severe limitations[16] - Macrobid has an estimated market share of ~33%[16] - Ciprofloxacin has an estimated market share of ~20%[17] - Bactrim has an estimated market share of ~20%[17] Financial Status - As of June 30, 2022, Iterum had $689 million in cash, cash equivalents, and short-term investments[46] - The company has $126 million in 6500% Exchangeable Senior Subordinated Notes due 2025[47]