Iterum Therapeutics Plc (ITRM -0.34%), an infectious disease biopharma company preparing to launch a new oral antibiotic for urinary tract infections, reported its results for the second quarter of 2025 on August 5, 2025. The key news in the release was its continued lack of revenue as it gears up for the first commercial sales of ORLYNVAH™, coupled with a larger operating loss driven by a jump in general and administrative costs. Reported non-GAAP loss per share came in at ($0.13), which was $0.02 below analyst expectations for non-GAAP EPS, while revenue (GAAP) was in line with estimates at zero. Overall, the quarter marked a pivotal transition phase, with significant expense increases for launch readiness but progress made in manufacturing, patent protection, and financial runway extension.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (Non-GAAP) | ($0.13) | ($0.11) | ($0.23) | 43.5 % |
| Revenue (GAAP) | $0.0 million | $0.0 million | $0.0 million | N/A |
| Operating Expenses | $5.5 million | N/A | N/A | |
| R&D Expenses | $1.0 million | $2.1 million | (52.4 % decrease) | |
| General & Administrative Expenses | $4.2 million | $1.9 million | 121.1 % |
Source: Analyst estimates provided by FactSet. Management expectations based on management's guidance, as provided in Q1 2025 earnings report.
Company Overview and Recent Focus
Iterum Therapeutics focuses on bringing new solutions to patients with serious infectious diseases, especially those where antibiotic resistance limits treatment options. Its most advanced product is ORLYNVAH™, an oral antibiotic tablet aimed at treating uncomplicated urinary tract infections (uUTIs), particularly cases caused by bacteria resistant to existing drugs.
The company’s recent efforts have targeted three areas: preparing for the first commercial launch of ORLYNVAH™, reinforcing patent protection to secure long-term value, and managing its financial position. Key factors for success include establishing commercial and distribution partnerships, navigating the regulatory landscape, and balancing operating costs to extend cash resources through launch.
Highlights From the Quarter: Financial and Operational Developments
The company reported no revenue in the quarter, which matches its pre-launch status and analyst forecasts. Non-GAAP EPS was a loss of $0.13, steeper than the anticipated $0.11 non-GAAP loss, largely due to a substantial increase in general and administrative (G&A) spending. This rise in G&A costs—from $1.9 million in the prior-year quarter to $4.2 million (GAAP)—was linked to investments in pre-commercialization work, such as market research and promotional strategy development.
Research and development (R&D) expenses dropped sharply to $1.0 million (GAAP). Research and development expenses were $1.0 million compared to $2.1 million for the same period in 2024, as clinical trial activity wound down following the conclusion of the REASSURE Phase 3 trial for ORLYNVAH™. Total operating expenses (GAAP) climbed 39.1% year over year, to $5.5 million, with the G&A increase outweighing the R&D savings. The net loss, using Generally Accepted Accounting Principles (GAAP), was $6.5 million, greater than the $5.0 million GAAP net loss in Q2 2024.
Operationally, Iterum put in place agreements to ensure manufacturing supply for ORLYNVAH™’s launch and expanded its intellectual property portfolio, securing a Canadian patent for its core antibiotic combination. The appointment of a new chief commercial officer signaled increased focus on market entry and execution. Iterum also finalized a commercialization agreement with EVERSANA to support U.S. sales, marketing, and distribution.
The balance sheet reflected both ongoing cash burn and steps to strengthen the company's financial position. Cash and equivalents totaled $13.0 million as of June 30, 2025, and management indicated this is sufficient to support operations, including the commercial launch, into 2026, based on cash and cash equivalents as of March 31, 2025, together with amounts raised under the Registered Direct Offering and at-the-market offering program. Of note, a $20.0 million milestone payment due to Pfizer was deferred until October 2029, easing the company’s near-term liquidity needs. At the end of the quarter, the company reported approximately 44.7 million shares outstanding, up meaningfully as new shares were issued to fund operations.
About the Product Pipeline and Intellectual Property
ORLYNVAH™ is an oral antibiotic tablet, or penem, formulated specifically for treating uncomplicated urinary tract infections in adult women when other oral options are limited or ineffective. The product stands out as the only oral penem approved by the U.S. Food and Drug Administration (FDA) and the first branded oral antibiotic in over 25 years for this indication.
Iterum has built a robust patent portfolio, now extending to December 2039 in Canada, which helps protect its sulopenem/probenecid combination from generic competition.
Looking Ahead: Management Outlook and Investor Watchpoints
For FY2025 and beyond, management expects the existing cash balance, together with recent capital raises, to cover operational and commercialization activities into 2026. No detailed revenue or profit guidance was provided, as focus remains on completing the U.S. launch of ORLYNVAH™ in late August and laying the foundation for future sales.
Other areas to monitor include expense trends—particularly in G&A as launch operations build out—and potential further equity raises given heightened cash needs ahead of revenue generation. Competitive developments will also be important, especially as other new antibiotics, such as from GlaxoSmithKline, move closer to market entry. ITRM does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
