Iterum Therapeutics plc Q2 FY2025 earnings call

• Hired Chief Commercial Officer Christine Coyne with extensive pharma/biotech experience to lead ORLYNVAH launch. - Expect to launch ORLYNVAH around August 20, 2025, ahead of previous timeline. - Target 20 geographic territories with sales resources, covering 2,300 high-value physicians (primary care, OB/GYN, urologists) who write 1-2 million annual uncomplicated UTI prescriptions. - Market access efforts ongoing with payers to gain coverage. - Pricing set between $1,400-$4,700 per course, similar to other oral antibiotic launches. - Executed commercial supply agreement with ACS Dobfar for ORLYNVAH manufacturing. - ORLYNVAH has 10 years market exclusivity in US (expiring 2034) and patents expiring 2039-2041. - Second quarter 2025 operating expenses $5.5M vs $4M in 2024; R&D $1M vs $2.1M in 2024 (due to REASSURE trial cost decrease); G&A $4.2M vs $1.9M in 2024 (due to pre-commercialization). - Cash and cash equivalents $13M at end of June; expects to fund operations into 2026 with additional proceeds from at-the-market offering. - Requested authorization of 80 million additional shares at AGM for financial flexibility.

There are no distinct product segments detailed; the focus is on the commercialization of ORLYNVAH. No absolute financial performance by segments provided as it's a single product focus.

• Expect to launch ORLYNVAH in US around August 20, 2025. - Cash and cash equivalents plus proceeds from at-the-market offering sufficient to fund operations into 2026. - Plan to expand commercial resources if initial launch successful, including adding geographies and physician targets. - Aim to have ORLYNVAH accessible in majority of key plans through payer discussions.

• Factors outside control that could affect forward-looking statements: ability to implement commercialization plans with EVERSANA, build sales force, market acceptance of ORLYNVAH, actions of third-party suppliers/manufacturers, going concern status, cash funding duration, and risks in Form 10-Q risk factors.

Q: Are there any registered questions?

A: There are no questions registered at this moment.