Summary of Fennec Pharmaceuticals FY Conference Call Company Overview - **Company**: Fennec Pharmaceuticals (NasdaqCM:FENC) - **Product**: PEDMARK, the first and only FDA-approved product to prevent cisplatin-induced ototoxicity [1][3] Industry Context - **Target Market**: Pediatric patients aged 1-18 and adolescents/young adults (AYA) aged 15-39 receiving cisplatin for localized non-metastatic tumors [4][6] - **Cisplatin Usage**: Approximately 2,000 pediatric patients and 20,000 AYA patients treated annually with cisplatin in the U.S. [5][29] Core Product Insights - **Efficacy**: PEDMARK has proven efficacy and safety data established through two phase three trials, with recent positive results from a trial in Japan [3][46] - **Administration**: PEDMARK is administered as a 15-minute IV infusion six hours after cisplatin treatment [25] - **Market Segmentation**: The product targets two segments: pediatric (2,000 patients) and AYA (20,000 patients), with a focus on germ cell/testicular cancer patients [5][13] Commercial Strategy - **Sales Infrastructure**: Fennec has approximately 40 employees, with half in customer-facing roles, including traditional sales reps and medical science liaisons (MSLs) [20][21] - **Growth in Awareness**: The company has doubled its MSL presence and established key account directors to enhance awareness in larger oncology networks [21][22] - **Home Health Administration**: About 33-40% of PEDMARK patients are now receiving infusions at home, reflecting growth in this area [27] Financial Performance - **Sales Growth**: Quarterly sales increased from approximately $7 million to $12.5 million, primarily driven by the AYA market [29] - **Pricing**: The wholesale acquisition cost (WAC) for PEDMARK is $11,000 per vial, with a gross-to-net discount of about 20% [39][40] Regulatory and Market Access - **Payer Reimbursement**: 100% reimbursement achieved across major carriers, indicating strong payer support for PEDMARK [38] - **Intellectual Property**: Fennec holds orphan drug exclusivity until September 2029 and six Orange Book patents extending to July 2039 [44] International Expansion - **Japan**: Positive trial results in Japan are expected to facilitate approval and market entry, with plans to partner with local entities [46][47] - **Europe**: Fennec has partnered with Norgine for European distribution, with initial launches in the UK and Germany [50][51] Challenges and Considerations - **Awareness Among Practitioners**: There is a need to increase awareness of PEDMARK among oncologists and nurses, particularly in community settings [32][33] - **Ototoxicity Management**: Education is crucial as once hearing loss occurs, it is irreversible, emphasizing the importance of prophylactic use of PEDMARK [35][36] Future Outlook - **Potential for Expansion**: Interest in conducting trials for PEDMARK in metastatic disease and adult populations is being explored [48] - **Continued Growth**: The company aims to build awareness and expand its market presence, particularly in the AYA segment [33][39]