Iterum Therapeutics plc Q3 FY2025 earnings call

• Orlynda was launched on August 20, 2025. Through November 12, more than 280 prescriptions were generated by over 100 unique prescribers, with nearly half of those prescribers having prescribed to more than one patient.
• Field operations: Reduced in-person field team to 10 from an original plan of 20, and are augmenting efforts with in-person and virtual sales representatives to cover at least initial 20 target geographies efficiently.
• Managed care and market access: Signed a rebate agreement with one of the top three Medicare Part D pharmacy benefit managers, and submitted bids for formulary inclusion across commercial, Medicare Part D, and government segments, aiming to secure long-term formulary positioning by late 2025 into Q1 2026. Coverage for Orlynda reaches 16% of insured lives.
• Patent updates: Granted a patent in China covering a combination of probenecid and valproic acid, expiring in March 2041, and a patent in Mexico covering a bilayer tablet, expiring in December 2039.

In the third quarter of 2025, Iterum Therapeutics generated net product sales of $400,000, primarily from the launch of Orlynda. For the fourth quarter of 2025, modest sales are expected. Looking ahead to 2026, the company currently expects full-year net product revenue to be in the range of $5 million to $15 million. Total operating expenses for 2026 are estimated to be between $25 million and $30 million.

• Full-year 2026 net product revenue is expected to be between $5 million and $15 million.
• Total operating expenses for 2026 are estimated to be between $25 million and $30 million.
• Existing cash and cash equivalents, along with proceeds from the at-the-market offering program, provide operating runway into 2026, but additional capital will likely be needed to continue commercialization in 2026.

• Ability to build and maintain a sales force and continue commercialization of Orlynda in the U.S.
• Market opportunity and acceptance of Orlynda.
• Actions of third-party suppliers, manufacturers, and contract sales organizations.
• Uncertainty regarding the company's ability to continue as a going concern.
• Accuracy of expectations regarding cash runway to fund ongoing operations, as discussed in the Form 10-K and 10-Q.

Q: Ed Arce from WestPark Capital asked about metrics reporting, physician details, and territories.

A: Corey N. Fishman stated they plan to report launch metrics, will be more specific in first couple of quarters, and started with 20 high-value territories, adjusting field organization with in-person and virtual reps to cover at least 20 territories efficiently.

Q: Jason McCarthy from Maxim Group asked about formulary submission, advertising, patient data.

A: Corey N. Fishman said bids were submitted to PBMs and Medicare Part D plans, they consider social media but have invested mostly in field organization, and will have anecdotal information from prescribing physicians on patient types but not specific confidential details.

Q: Ed Arce from WestPark Capital asked about virtual reps and marketing channels.

A: Corey N. Fishman said they will use a combination of in-field and virtual reps, virtual reps are efficient, and they consider other marketing channels but focus on field organization for now with plans to optimize if additional capital is raised.