Iterum Therapeutics (ITRM) Investor presentation summary

Product overview and market need

• ORLYNVAH™ is the first and only FDA-approved oral penem antibiotic for uncomplicated urinary tract infections (UUTIs), launched in August 2025 and indicated for adult women with limited or no alternative oral antibacterial options.

• The product targets a significant U.S. market with approximately 40 million UUTI prescriptions annually, with about 26 million for at-risk patients such as the elderly, diabetics, or those with recurrent infections.

• ORLYNVAH™ addresses the growing threat of multi-drug resistant bacteria and offers a novel solution for at-risk patients who previously relied on IV therapies.

• The tablet combines sulopenem etzadroxil and probenecid, is patent-protected, and offers protection into 2039 in the U.S. and key international markets.

• High resistance rates to existing oral therapies and safety concerns highlight the need for new options like ORLYNVAH™.

Clinical efficacy and safety

• ORLYNVAH™ demonstrated non-inferiority and statistical superiority to Augmentin® in certain populations and higher response rates compared to ciprofloxacin in quinolone-resistant infections.

• In pivotal Phase 3 trials, ORLYNVAH™ showed favorable safety, with most adverse events being mild and low rates of serious adverse events.

• The product is administered as one tablet twice daily for five days.

• Clinical experience post-launch has been positive, especially for women with recurrent infections and those seeking to avoid hospital admissions.

Commercial performance and market access

• Q3 2025 product sales reached $0.4M, with over 250 unique physician prescribers and a 40% prescription fill rate expected to rise as payer coverage expands.

• Two major commercial contracts and two top Medicare Part D rebate agreements have been secured, providing coverage opportunities for over 81 million lives starting January 2026.

• The sales force targets the top decile of UUTI prescribers, representing about 8 million prescriptions annually, and specialty distribution is in place for broader access.

• High interest from key opinion leaders and group practices is driving follow-up discussions and early adoption.