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Iterum Therapeutics (ITRM) investor relations material
Iterum Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary14 Nov, 2025
Executive summary
Orlynvah (oral sulopenem) launched in the U.S. in August 2025 for uncomplicated urinary tract infections, marking the first new branded launch in this space in over 25 years and targeting adult women with limited treatment options.
Over 280 prescriptions were generated by more than 100 unique prescribers through November 12, with nearly half prescribing to multiple patients, indicating growing physician comfort and repeat use.
Commercial efforts include both in-person and virtual sales representatives, with a reduction in field team size offset by virtual augmentation to maintain or exceed coverage in at least 20 target geographies.
Customer feedback highlights Orlynvah’s value in treating resistant infections and keeping patients out of the hospital, with strong interest from infectious disease specialists.
FDA approval was received in October 2024, and the company is focused on maximizing Orlynvah’s commercial potential and expanding its sulopenem program.
Financial highlights
Net product revenue for Q3 2025 was $0.4 million, reflecting initial stocking and early sales post-launch.
Net loss (GAAP) was $9 million in Q3 2025, compared to $6.1 million in Q3 2024; non-GAAP net loss was $7.3 million versus $4.8 million year-over-year.
Operating expenses rose to $8.1 million in Q3 2025 from $4.9 million in Q3 2024, driven by commercialization activities.
Cash and cash equivalents stood at $11 million at the end of September 2025, with an additional $2.6 million raised post-quarter.
Accumulated deficit reached $506.5 million as of September 30, 2025.
Outlook and guidance
Full-year 2026 net product revenue is expected to be between $5 million and $15 million, with operating expenses projected at $25–$30 million.
Cash runway is expected to last into Q2 2026, including proceeds from recent fundraising.
Additional capital will be required to continue commercialization through 2026, with plans to seek shareholder approval for further share issuance.
Management expects continued significant operating losses as commercialization and development activities expand.
Substantial doubt exists about the ability to continue as a going concern without additional funding.
Payer coverage outlook for ORLYNVAH?
Plan to extend cash runway past Q2 2026?
Value of new China/Mexico patents?
Detail capital raise strategy for 2026 operations
How does the new sales model drive 2026 revenue?
PBM coverage: What's the Q1 2026 outlook?
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Next Iterum Therapeutics earnings date
Q4 202520 Mar, 2026
Next Iterum Therapeutics earnings date
Q4 202520 Mar, 2026
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Frequently asked questions
Iterum Therapeutics plc is a clinical-stage pharmaceutical company focused on developing novel anti-infective therapies. The company is working on next-generation oral and intravenous antibiotics designed to combat infections caused by multi-drug resistant pathogens, which are a growing global health concern. Iterum's lead product candidate, sulopenem, is a novel penem antibiotic that has shown potent activity against a broad spectrum of bacteria, including strains that are resistant to other antibiotics. Iterum Therapeutics is headquartered in Dublin, Ireland, and its shares are listed on the NASDAQ.
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