• Total Operating Expenses (Q4 2024): $3.7 million
• Total Operating Expenses (Full Year 2024): $18.7 million
• R&D Costs (Q4 2024): $1.3 million
• R&D Costs (Full Year 2024): $10.5 million
• G&A Costs (Q4 2024): $2.1 million
• G&A Costs (Full Year 2024): $8 million
• Net Loss (GAAP, Q4 2024): $6.6 million
• Net Loss (GAAP, Full Year 2024): $24.8 million
• Net Loss (Non-GAAP, Q4 2024): $3.4 million
• Net Loss (Non-GAAP, Full Year 2024): $17.9 million
• Cash and Cash Equivalents (End of December 2024): $24.1 million
• Cash and Cash Equivalents (Including ATM Proceeds): Sufficient to fund operations into the second half of 2025
• Regulatory Milestone Payment to Pfizer: $20 million deferred, with 8% interest
• Ordinary Shares Outstanding (As of February 6, 2025): Approximately 34.6 million

• Warning! GuruFocus has detected 2 Warning Signs with ITRM.

Release Date: February 07, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Iterum Therapeutics PLC (NASDAQ:ITRM) received FDA approval for ORLYNVAH, the first and only oral penem approved in the United States.
• ORLYNVAH addresses a significant unmet need in the uncomplicated urinary tract infection market, which generates an estimated 40 million prescriptions annually in the US.
• The company has secured 10 years of market exclusivity for ORLYNVAH under the GAIN Act, with additional patent protection extending into 2039.
• Iterum Therapeutics PLC (NASDAQ:ITRM) has reduced its operating expenses significantly, with a notable decrease in R&D costs due to the completion of the REASSURE trial.
• The company has sufficient cash resources to fund operations into the second half of 2025, providing a stable financial outlook for the near future.

Negative Points

• Iterum Therapeutics PLC (NASDAQ:ITRM) faces challenges in securing a strategic transaction to sell, license, or dispose of ORLYNVAH, with no definitive offers yet received.
• The company has a significant financial obligation to Pfizer, with a $20 million regulatory milestone payment deferred and accruing interest at 8% annually.
• Iterum Therapeutics PLC (NASDAQ:ITRM) reported a net loss of $24.8 million for the full year 2024, indicating ongoing financial challenges.
• There is uncertainty regarding the successful commercialization of ORLYNVAH, as it depends on raising sufficient capital and potentially finding a commercial partner.
• The market for uncomplicated urinary tract infections is highly competitive, with existing products having established resistance rates, posing a challenge for ORLYNVAH's market penetration.

Q & A Highlights

Q: Can you discuss any feedback or details on your ongoing discussions with potential partners? What type of entities are you having discussions with, such as pharma companies or financial organizations? A: Corey Fishman, President, CEO, and Director: We can't discuss ongoing conversations in detail, but we've reached out to dozens of companies, including both pharma companies and financial investors. The process is ongoing.

Q: Can you highlight some activities related to your commercial preparations? A: Corey Fishman, President, CEO, and Director: We are engaging in research with payers and physicians and conducting analytics around targeting geographies. This is to lay the foundation for a potential commercial launch, either by us or with a partner, if a strategic transaction does not occur or is insufficient.

Q: What are the key priorities for Iterum Therapeutics in 2025? A: Corey Fishman, President, CEO, and Director: Our key priority is the strategic process to sell, license, or dispose of our rights to ORLYNVAH to maximize stakeholder value. We are also evaluating other options, including raising capital for commercialization.

Q: What is the financial outlook for Iterum Therapeutics? A: Judith Matthews, Chief Financial Officer: Based on our current operating plan, we expect our cash and cash equivalents, including recent proceeds, to fund operations into the second half of 2025. We have deferred a $20 million milestone payment to Pfizer for two years.

Q: What is the significance of ORLYNVAH's FDA approval for Iterum Therapeutics? A: Corey Fishman, President, CEO, and Director: ORLYNVAH is the first and only oral penem approved in the US, addressing an underserved market with substantial unmet needs for effective treatment options for uncomplicated urinary tract infections.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.