Iterum Therapeutics plc
Iterum Therapeutics plc Q4 FY2024 earnings call
February 7, 2025 · fiscal period ended 2024-12
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2025-02-07
Management highlights
• 2024 was a pivotal year with FDA approval of ORLYNVAH in October 2024. ORLYNVAH is the first oral penem approved in the US for uncomplicated urinary tract infections. • Uncomplicated UTI market in US is large (40M prescriptions annually) with rising resistance and safety concerns for existing treatments. • ORLYNVAH has 10 years of marketing exclusivity under GAIN Act and patent protection into 2039. • In 2024, operating expenses were $3.7M in Q4 and $18.7M full year; R&D costs decreased due to completion of REASSURE trial. • Net loss on US GAAP was $6.6M Q4 2024 and $24.8M full year; non-GAAP net loss also decreased. • Cash and cash equivalents at end of Dec 2024 were $24.1M, expected to fund operations into second half of 2025.
Segment performance
No distinct product segments discussed; focus is on ORLYNVAH which received FDA approval in Oct 2024 for uncomplicated urinary tract infections.
Guidance
• Ongoing strategic process to sell, license, or dispose of rights to ORLYNVAH to maximize value. • Engaging in pre-commercial activities for ORLYNVAH. • Cash and cash equivalents, including net proceeds from ATM, expected to fund operations into second half of 2025.
Risks
• Forward-looking statements may differ due to factors like outcome of strategic alternatives, ability to complete transactions, market acceptance of ORLYNVAH, going concern, and accuracy of cash funding expectations. • Risks discussed in annual report filed with SEC including evaluation of strategic alternatives, ability to complete transactions, capital raising, and commercialization plans.
Q&A highlights
Q: Discuss feedback on ongoing discussions with potential partners and types of entities being engaged with.
A: Can't discuss detailed ongoing conversations, but outreach to dozens of companies including pharma and financial investors is ongoing.
Q: Highlight commercial preparations activities.
A: Engaging with payers, physicians, doing analytics on targeting and geographies to lay foundation for potential commercial launch if strategic transaction doesn't occur
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.12 | $-0.24 | +50.0% | — |
| Revenue | — | $1.3M | — | — |
Transcript
February 7, 2025Full transcript unavailable for redistribution
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