Tue, May 13, 11:32 AM (62 days ago)
**Summary of Iterum Therapeutics plc (ITRM) Q1 2025 Financial Performance** **Revenue and Profit Margins:** - **Revenue:** Iterum Therapeutics reported no revenue for the quarter, consistent with previous quarters. - **Gross Profit Margin:** The company reported a gross loss of $342,000, primarily due to amortization associated with the regulatory milestone payable to Pfizer upon approval of ORLYNVAH™. - **Operating Profit Margin:** The operating loss was $3.71 million, reflecting costs related to research and development, general and administrative expenses, and other operating expenses. - **Net Profit Margin:** The net loss for the quarter was $4.89 million, after accounting for interest expenses, adjustments to fair value of derivatives, and other expenses. **Cash Flow:** - **Operating Cash Flow:** The company used $3.06 million in cash from operating activities, primarily due to the net loss and changes in operating assets and liabilities. - **Investing Cash Flow:** The company used a nominal amount of cash for investing activities, primarily for the purchase of computer equipment. - **Financing Cash Flow:** The company used $8.39 million in cash from financing activities, primarily due to the repayment of exchangeable notes. **Earnings Changes:** - **Year-over-Year Change:** The net loss increased by $1.20 million compared to the same quarter last year, primarily due to higher research and development expenses and other operating costs. - **Quarter-over-Quarter Change:** The net loss decreased by $2.22 million compared to the previous quarter, primarily due to lower research and development expenses. **Quarterly Performance Discussion:** - **Research and Development (R&D) Expenses:** R&D expenses decreased by $3.39 million compared to the same quarter last year, primarily due to lower costs incurred in connection with the completion of the REASSURE trial. - **General and Administrative (G&A) Expenses:** G&A expenses increased by $591,000 compared to the same quarter last year, primarily due to higher consulting fees related to pre-commercialization activities. - **Interest Expense:** Interest expense increased by $47,000 compared to the same quarter last year, primarily due to higher interest accrued on the Pfizer Promissory Note. **Trends and Uncertainties:** - **Cash Usage:** The company expects to continue to incur significant expenses and increasing operating losses in connection with its ongoing activities, including any expenses that may be incurred in preparation for and the potential commercial launch of ORLYNVAH™. - **Funding Requirements:** The company's future viability is dependent on its ability to raise additional capital to finance its operations. Without additional external funding, the company does not believe that its existing cash and cash equivalents will enable it to fund its operating expenses for the next 12 months. - **Strategic Alternatives:** The company is evaluating its corporate, strategic, financial, and financing alternatives, with the goal of maximizing value for its stakeholders while prudently managing its resources. **Future Operations Impact:** - **Commercialization:** The company is preparing for the potential commercialization of ORLYNVAH™ in the United States with a commercial partner and/or on its own with a targeted sales force in the community setting. - **Strategic Transaction:** The company continues to pursue a strategic transaction to sell, license, or otherwise dispose of its rights to sulopenem with the goal of maximizing value for its stakeholders. - **Regulatory Approval:** The company received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for ORLYNVAH™ for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options.