• Total Operating Expenses: $4.9 million in Q3 2024, down from $16.7 million in Q3 2023.
• Research and Development Costs: $3.1 million in Q3 2024, compared to $14.9 million in Q3 2023.
• General and Administrative Costs: $1.8 million in Q3 2024, consistent with Q3 2023.
• Net Loss (GAAP): $6.1 million in Q3 2024, compared to $3.9 million in Q3 2023.
• Net Loss (Non-GAAP): $4.8 million in Q3 2024, compared to $15.7 million in Q3 2023.
• Cash, Cash Equivalents, and Short-term Investments: $14.5 million at the end of September 2024.
• Ordinary Shares Outstanding: Approximately 27.5 million as of November 4, 2024.
• Exchangeable Notes Outstanding: Approximately $11.1 million, exchangeable for about 1.9 million shares.
• Regulatory Milestone Payment to Pfizer: $20 million deferred for two years via promissory note.

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

Release Date: November 14, 2024

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 Arlinda, an oral sulopenem product, marking the first U.S. approval of an oral product in the penem class of drugs.
• Arlinda has been granted 10 years of market exclusivity under the GAIN Act, extending protection until October 25, 2034.
• The U.S. patent portfolio provides protection for oral sulopenem until 2039, with issued patents covering both method of use and composition of matter.
• The company has significantly reduced its operating expenses, with a decrease in R&D costs from $14.9 million in Q3 2023 to $3.1 million in Q3 2024.
• Iterum Therapeutics PLC (NASDAQ:ITRM) expects to fund operations into 2025, including through the repayment date of exchangeable notes due January 31, 2025.

Negative Points

• Iterum Therapeutics PLC (NASDAQ:ITRM) faces uncertainties regarding the completion of a strategic transaction to sell, license, or dispose of rights to Arlinda.
• The company has approximately $11.1 million of exchangeable notes outstanding, which could require repayment if not exchanged.
• A $20 million regulatory milestone payment to Pfizer has been deferred for two years, indicating potential financial obligations.
• Iterum Therapeutics PLC (NASDAQ:ITRM) has not yet been granted European patents, limiting its current patent protection to the U.S. and a few other territories.
• The company reported a net loss of $6.1 million for Q3 2024, compared to $3.9 million for the same period in 2023, indicating ongoing financial challenges.

Q & A Highlights

Q: With 10 years of market exclusivity up to 2034, how far does the patent portfolio provide coverage in the US and Europe? A: Corey Fishman, CEO: The Gain Act provides 10 years of market exclusivity from the date of approval, extending to 2034. Our US patents extend into 2039, and we have similar coverage in other territories like Japan and Australia. However, European patents have not yet been granted.

Q: Did the approved label for Arlinda meet your internal expectations in terms of breadth and restrictions? A: Corey Fishman, CEO: We are very pleased with the label, which aligns with our focus on treating at-risk patients. The label allows us to address the needs of patients with limited oral options due to resistance and safety profiles of existing drugs. There are no unusual restrictions or post-marketing requirements beyond standard pediatric studies and surveillance.

Q: What is your impression of the strategic options discussions to date? A: Corey Fishman, CEO: We have renewed our process with our financial adviser to explore strategic transactions. This effort is ongoing, and we are monitoring it closely following the recent approval.

Q: From a partnering perspective, would additional trials be needed in regions like the EU, China, or Japan to extend approvals beyond the US? A: Corey Fishman, CEO: In the EU, the current data package is sufficient for filing without additional trials. However, in China and Japan, a local study would be required for approval. Most other regions can use the FDA data.

Q: Could the data from the complicated UTI trial, despite missing the endpoint, make the product more attractive to partners? A: Corey Fishman, CEO: There is interest in using Arlinda as a step-down drug for complicated UTIs. Although we missed the endpoint, we believe a single additional study could achieve approval. This could be attractive to partners, especially for its potential use in hospitals to send patients home with an oral option.

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