Fennec Pharma(US:FENC)2025-11-13 21:02Financial Performance - PEDMARK® recorded net product sales of $12,462,000 in Q3 2025, a 78% increase from $6,974,000 in Q3 2024, driven by increased market penetration and focus on the adolescent and young adult population [163]. - Net product sales for the first three quarters of 2025 reached $30,865, a 42.5% increase from $21,655 in 2024, driven by increased market penetration and focus on the adolescent and young adult population [167]. - Total revenue for the nine months ended September 30, 2025, was $30,865, down from $39,613 in 2024, reflecting a decrease of $8,748 [165]. - The net loss for the nine months ended September 30, 2025, was $4,954, compared to a net income of $1,549 in 2024, representing a decline of $6,503 [165]. Expenses - Selling and marketing expenses rose to $5,210,000 in Q3 2025 from $4,601,000 in Q3 2024, reflecting enhanced commercial and marketing efforts in the U.S. [163]. - General and administrative expenses increased by $631,000 in Q3 2025 compared to the same period in 2024 [164]. - Operating expenses totaled $34,593 for the nine months ended September 30, 2025, a decrease of $1,518 compared to $36,111 in 2024 [165]. - Selling and marketing expenses decreased to $12,510 in 2025 from $14,482 in 2024, primarily due to the completion of European pre-commercial activities [167]. Cash Flow and Liabilities - Cash and equivalents decreased to $21,947 as of September 30, 2025, from $26,634 as of December 31, 2024, a net decrease of $4,687 [169]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $(6,511), compared to $28,454 provided in 2024 [170]. - Current liabilities increased to $9,815 as of September 30, 2025, from $6,919 as of December 31, 2024, an increase of $2,896 [169]. Product Development and Approvals - The company received European Commission Marketing Authorization for PEDMARQSI® in June 2023, with U.K. approval following in October 2023 [156]. - An exclusive licensing agreement with Norgine was established in March 2024, providing approximately $43,200,000 upfront and potential future milestone and royalty payments of up to $230,000,000 [141]. - PEDMARK® is the first and only FDA- and EMA-approved therapy to reduce the risk of cisplatin-induced hearing loss in pediatric patients aged one month and older [146]. - The company received Orphan Drug Exclusivity for PEDMARK® in January 2023, granting seven years of market exclusivity until September 20, 2029 [143]. - Norgine plans to launch PEDMARQSI® in Germany and the U.K. in early 2025 [159]. Market Potential - It is estimated that over 10,000 pediatric patients receive platinum-based chemotherapy annually in the U.S. and Europe, with more than 50% potentially suffering permanent hearing loss due to cisplatin [149][155]. - The company has six patents listed for PEDMARK® in the FDA Orange Book, with expiration dates extending to 2039 [143]. Shareholder Information - Outstanding common shares increased to 28,062 as of September 30, 2025, from 27,527 as of December 31, 2024, an increase of 535 shares [174]. - Common shares are recorded as net proceeds after deducting share issuance costs and the fair value of investor warrants, which are recorded as additional paid-in capital [193]. Stock Options and Performance Units - The fair value of stock options is estimated using the Black-Scholes model with a risk-free rate of 3.93-4.19% and expected volatility ranging from 71.04% to 161.67% [191]. - Performance-based units (PSUs) were granted in May and August 2025, with vesting dependent on revenue performance milestones, which are deemed probable as of September 30, 2025 [192].