Iterum Therapeutics(US:ITRM)2025-11-14 12:15Product Launch and Sales - Iterum Therapeutics launched ORLYNVAH™ in the United States in August 2025 for the treatment of uncomplicated urinary tract infections (uUTIs) after over 25 years without new branded launches in this space[3] - Net product revenues for the third quarter of 2025 were $0.4 million, reflecting initial sales of ORLYNVAH™[7] - The company expects net product sales of ORLYNVAH™ to range between $5 million and $15 million in 2026, depending on market uptake and payer coverage[3] Financial Performance - The net loss for the third quarter of 2025 was $9.0 million, compared to a net loss of $6.1 million for the same period in 2024[13] - Product revenue for the three months ended September 30, 2025, was $390 million, with no revenue reported for the same period in 2024[25] - The net loss for the three months ended September 30, 2025, was $8,979 million, compared to a net loss of $6,094 million for the same period in 2024, indicating a 47% increase in losses[25] - Non-GAAP net loss for the three months ended September 30, 2025, was $7,342 million, compared to $4,837 million for the same period in 2024, reflecting a 52% increase[25] Expenses - Research and development expenses decreased to $1.3 million in Q3 2025 from $3.1 million in Q3 2024, primarily due to lower chemistry, manufacturing, and control expenses[10] - Selling, general, and administrative expenses increased to $6.5 million in Q3 2025 from $1.8 million in Q3 2024, attributed to the commercialization of ORLYNVAH™[11] - Total operating expenses for the three months ended September 30, 2025, were $8,121 million, compared to $4,887 million for the same period in 2024, representing a 66% increase[25] - Research and development expenses for the three months ended September 30, 2025, were $1,261 million, compared to $3,107 million for the same period in 2024, showing a decrease of 59%[25] Cash and Assets - Cash and cash equivalents were $11.0 million as of September 30, 2025, with an extended cash runway projected into Q2 2026[6] - Cash, cash equivalents, and short-term investments decreased to $11,002 million as of September 30, 2025, down from $24,125 million as of December 31, 2024[27] - Total assets decreased to $32,503 million as of September 30, 2025, from $44,595 million as of December 31, 2024[27] - Total liabilities decreased to $39,884 million as of September 30, 2025, from $48,676 million as of December 31, 2024[27] Shareholder Information - The company reported a weighted average of 45,801,927 ordinary shares outstanding for the three months ended September 30, 2025, compared to 20,044,270 for the same period in 2024[25] Intellectual Property and Research - Iterum has been granted a patent in China for a combination treatment related to sulopenem, projected to expire in March 2041[4] - The company presented two posters at the IDWeek 2025 conference, highlighting its focus on urinary tract infections[5] Derivatives and Amortization - Adjustments to the fair value of derivatives for Q3 2025 were $0.7 million, compared to $0.4 million for the same period in 2024[12] - The amortization of intangible assets for the three months ended September 30, 2025, was $349 million, with no amortization reported for the same period in 2024[25]