In This Article:
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Total Operating Expenses (Q4 2024): $3.7 million
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Total Operating Expenses (Full Year 2024): $18.7 million
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R&D Costs (Q4 2024): $1.3 million
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R&D Costs (Full Year 2024): $10.5 million
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G&A Costs (Q4 2024): $2.1 million
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G&A Costs (Full Year 2024): $8 million
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Net Loss (GAAP, Q4 2024): $6.6 million
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Net Loss (GAAP, Full Year 2024): $24.8 million
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Net Loss (Non-GAAP, Q4 2024): $3.4 million
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Net Loss (Non-GAAP, Full Year 2024): $17.9 million
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Cash and Cash Equivalents (End of December 2024): $24.1 million
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Cash and Cash Equivalents (Including ATM Proceeds): Sufficient to fund operations into the second half of 2025
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Regulatory Milestone Payment to Pfizer: $20 million deferred, with 8% interest
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Ordinary Shares Outstanding (As of February 6, 2025): Approximately 34.6 million
Release Date: February 07, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Iterum Therapeutics PLC (NASDAQ:ITRM) received FDA approval for ORLYNVAH, the first and only oral penem approved in the United States.
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ORLYNVAH addresses a significant unmet need in the uncomplicated urinary tract infection market, which generates an estimated 40 million prescriptions annually in the US.
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The company has secured 10 years of market exclusivity for ORLYNVAH under the GAIN Act, with additional patent protection extending into 2039.
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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.
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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
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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.
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The company has a significant financial obligation to Pfizer, with a $20 million regulatory milestone payment deferred and accruing interest at 8% annually.
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Iterum Therapeutics PLC (NASDAQ:ITRM) reported a net loss of $24.8 million for the full year 2024, indicating ongoing financial challenges.
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There is uncertainty regarding the successful commercialization of ORLYNVAH, as it depends on raising sufficient capital and potentially finding a commercial partner.
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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.