Iterum Therapeutics plc Q3 FY2024 earnings call

• FDA approved ORLYNVAH for uncomplicated urinary tract infections in adult women with limited alternatives; it's the first U.S. oral penem.
• ORLYNVAH has 10 years of market exclusivity under the GAIN Act (until 2034) and U.S. patent protection into 2039.
• The uncomplicated UTI market had limited innovation for decades with rising resistance and safety issues.
• ORLYNVAH targets at-risk patients and those with resistant pathogens.
• Financial results for Q3 2024 showed lower expenses and net loss compared to the prior year.

In the third quarter of 2024, total operating expenses were $4.9 million, down from $16.7 million in the same period of 2023. R&D costs were $3.1 million in Q3 2024 vs. $14.9 million in Q3 2023. GAAP net loss was $6.1 million in Q3 2024 vs. $3.9 million in Q3 2023. Non-GAAP net loss was $4.8 million in Q3 2024 vs. $15.7 million in Q3 2023. At the end of September, cash, cash equivalents, and short-term investments were $14.5 million. There are $11.1 million of exchangeable notes outstanding, and a $20 million regulatory milestone to Pfizer is deferred for two years.

• Expect to fund operations into 2025 including repayment of exchangeable notes due January 31, 2025.
• $11.1 million exchangeable notes can be exchanged for shares or repaid with interest in January 2025.
• $20 million regulatory milestone to Pfizer is deferred for two years via promissory note.

• Uncertainty around strategic alternatives, including terms, timing, and ability to complete transactions.
• Market acceptance of ORLYNVAH.
• Cash runway and ability to fund operations.
• Maintaining NASDAQ listing.
• Risks related to patent protection in Europe and other territories.

Q: Discuss how far out the sulopenem portfolio provides coverage in U.S. and Europe?

A: GAIN Act gives 10 years exclusivity until 2034. U.S. patents cover until 2039, but Europe has not yet granted patents.

Q: Did ORLYNVAH label meet internal expectations in terms of breadth and restrictions?

A: Pleased with the label, it's broad for at-risk patients with no unusual restrictions.

Q: Regarding strategic options and approvals in EU, China, Japan?

A: EU can use current data; China and Japan may need local trials; complicated UTI could be a potential area of interest for partners.