Iterum Therapeutics(US:ITRM)2025-11-14 12:30Commercialization of ORLYNVAH™ - ORLYNVAH™ was commercially launched in the United States in August 2025, with modest sales expected during the early stages of commercialization efforts[166]. - The commercialization partner EVERSANA will provide sales and commercial operations services for ORLYNVAH™ under a five-year agreement[168][169]. - The company plans to continue commercialization efforts for ORLYNVAH™ and expand its research and development programs, which will require additional capital[243][246]. - The company has limited net product sales to date since the launch of ORLYNVAH™ in August 2025, with revenues expected to fluctuate in future periods[182]. - Product revenue for the three months ended September 30, 2025, was $0.4 million, compared to $0.0 million for the same period in 2024, reflecting the launch of ORLYNVAH™ in August 2025[198]. - For the nine months ended September 30, 2025, product revenue was $0.4 million, up from $0.0 million in 2024, driven by ORLYNVAH™ sales[208]. Financial Performance and Losses - The company incurred net losses of $20.4 million and $18.2 million for the nine months ended September 30, 2025 and 2024, respectively, and an accumulated deficit of $506.5 million as of September 30, 2025[172]. - The company expects to continue incurring significant expenses and increased operating losses as it focuses on maximizing the commercial potential of ORLYNVAH™[167]. - The operating loss for the three months ended September 30, 2025, was $7.7 million, compared to a loss of $4.9 million in 2024, an increase of $2.8 million[197]. - Loss before income taxes for the nine months ended September 30, 2025, was $20.1 million, compared to a loss of $18.0 million in 2024, an increase of $2.1 million[207]. - Total operating expenses for the three months ended September 30, 2025, were $8.1 million, an increase of $3.2 million from $4.9 million in 2024[197]. - Total operating expenses for the nine months ended September 30, 2025, were $17.4 million, an increase of $2.3 million from $15.0 million in 2024[207]. Cash Position and Funding - As of September 30, 2025, the company had cash and cash equivalents of $11.0 million, raising substantial doubt about its ability to continue as a going concern[176]. - The company had cash and cash equivalents of $11.0 million as of September 30, 2025, but does not believe this will cover operating expenses for the next 12 months, raising substantial doubt about its ability to continue as a going concern[243][244]. - The company sold 11,875,589 ordinary shares under the Sales Agreement at an average net price of $1.07 per share, generating net proceeds of $12.7 million[220]. - The company registered for sale up to $150.0 million of various securities under the 2025 Shelf Registration Statement, effective February 19, 2025[219]. - During the nine months ended September 30, 2025, net cash provided by financing activities was $2.2 million, primarily from the sale of ordinary shares and the April 2025 Registered Direct Offering[241]. - The company generated net proceeds of approximately $42.1 million from the February 2021 Underwritten Offering, which included the sale of 2,666,666 ordinary shares[233]. Expenses and Cost Management - Selling, general and administrative expenses increased significantly to $6.5 million for the three months ended September 30, 2025, compared to $1.8 million in 2024, an increase of $4.7 million[202]. - Research and development expenses decreased to $1.3 million for the three months ended September 30, 2025, from $3.1 million in 2024, a reduction of $1.8 million[201]. - Research and development expenses for the nine months ended September 30, 2025, were $2.9 million, down from $9.2 million in 2024, a decrease of $6.3 million[211]. - Personnel related costs decreased by $0.3 million due to a reduction in accrued bonuses, while professional and consulting fees increased by $8.2 million, primarily for pre-commercialization and commercialization activities[212]. - The company anticipates increased expenses due to inflation and a competitive wage environment, which may affect future operating costs[245]. Strategic Planning and Future Outlook - The company is continuously evaluating corporate, strategic, financial, and financing alternatives to maximize value for stakeholders[178]. - The company is actively considering contingency plans, including alternative sourcing strategies, to mitigate potential future impacts from increased tariffs and trade tensions[249]. - The company is evaluating corporate, strategic, financial, and financing alternatives to maximize shareholder value while managing resources prudently[251]. Regulatory and Market Considerations - The company received FDA approval for ORLYNVAH™ on October 25, 2024, for the treatment of uncomplicated urinary tract infections[225]. - The company is obligated to pay Pfizer sales milestones upon achievement of net sales ranging from $250.0 million to $1.0 billion for each product type, as well as royalties ranging from single-digit to mid-teens percentage based on marginal net sales of each licensed product[252]. - Payments to holders of RLNs will be due within 75 days of the end of each six-month payment measuring period, with a payment rate of 15% based on specified net revenues from U.S. sales of sulopenem products[254]. - The company has agreements with contract service providers that represent significant costs in research and development and commercial activities[253]. - The new reciprocal tariff rates range from 10% to 41%, with imports from Switzerland receiving a 39% rate, while the baseline tariff on China remains at 10%[248]. - The company may face a 100% tariff on all branded or patented drugs imported into the U.S. starting October 1, 2025, unless manufacturing facilities are built in the U.S.[248]. Foreign Currency and Inflation Impact - The company has not engaged in any hedging activities against foreign currency exchange rate risk, and realized net foreign currency gains and losses did not materially affect operations[257]. - Inflation has not had a material effect on the company's financial statements to date, but future operations may be adversely affected by inflation[258]. - The company experienced a net cash decrease of $13.1 million for the nine months ended September 30, 2025, compared to an increase of $7.3 million in the same period of 2024[237].