Fennec Pharma(FENC) - 2024 Q4 - Annual Results

Financial Performance - Full-Year PEDMARK® net product sales reached $29.6 million, a 40% increase year-over-year, with Q4 2024 net product sales of $7.9 million[1] - The company reported a Q4 2024 EBITDA loss of $0.6 million and had $26.6 million in cash, cash equivalents, and short-term investments[1] - Cash flow from operations decreased by $0.6 million in Q4 2024, but there was a $13.4 million increase in cash and cash equivalents from December 31, 2023, to December 31, 2024[7] - Selling and marketing expenses for FY 2024 were $18.4 million, up from $12.1 million in FY 2023, primarily due to increased payroll and marketing efforts[7] - General and administrative expenses for FY 2024 were $23.1 million, compared to $20.6 million in FY 2023, influenced by European pre-commercialization expenses and costs associated with the Norgine transaction[8] Debt Management - Early repayment of $13 million of the company's convertible debt facility was completed, optimizing the balance sheet and saving approximately $1.5 million in future annual interest payments[7] Product Development and Approval - PEDMARK® is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors[18] - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023[31] - The Japan clinical trial (STS-J01) for PEDMARK® is fully enrolled, with results expected in the second half of 2025, potentially leading to registration in Japan[7] - PEDMARQSI® is now commercially available in the United Kingdom and Germany, expanding global access to the product[2] Clinical Efficacy and Safety - PEDMARK has proven efficacy and safety data established through two Phase 3 clinical studies, COG ACCL0431 and SIOPEL 6[21] - The COG ACCL0431 protocol enrolled patients with various childhood cancers treated with intensive cisplatin therapy, while SIOPEL 6 focused on hepatoblastoma patients[21] - Hypersensitivity reactions occurred in 8% to 13% of patients during clinical trials, necessitating monitoring for such reactions[25] - Hypernatremia occurred in 12% to 26% of patients, while hypokalemia occurred in 15% to 27% of patients during clinical trials[27] - The most common adverse reactions in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia, while hypokalemia was most common in COG ACCL0431[29] Market Potential and Strategy - Over 10,000 children in the U.S. and Europe may receive platinum-based chemotherapy annually, with many requiring lifelong hearing aids due to ototoxicity[20] - Fennec Pharmaceuticals emphasizes the potential market impact and commercialization plans for PEDMARK, alongside anticipated regulatory milestones and funding opportunities[32] - The company is focused on expanding access to PEDMARQSI® for cancer patients at risk of hearing loss, with significant milestones achieved in Europe[5]