Fennec Pharma(US:FENC)2023-05-14 03:34Financial Data and Key Metrics Changes - The company reported gross PEDMARK sales of $1.9 million, translating into net product sales of $1.7 million in Q1 2023, indicating a solid start for the product launch [84] - General and administrative expenses for Q1 2023 were $4.3 million, up from $2.1 million in Q1 2022, reflecting ongoing support for PEDMARK and increased professional and legal expenses [85] - GAAP net loss for Q1 2023 was $6 million, or a loss of $0.23 per share, compared to a GAAP net loss of $3.7 million, or a loss of $0.14 per share in Q1 2022 [88] Business Line Data and Key Metrics Changes - Selling and marketing expenses amounted to $2.5 million in Q1 2023, reflecting the expansion of the internal sales force for PEDMARK's launch [87] - R&D expenses decreased by $1.4 million compared to Q1 2022, as most traditional R&D costs are now recorded as general and administrative expenses or capitalized into inventory [86] Market Data and Key Metrics Changes - Approximately 50% of pediatric oncology patients are commercially insured, with the other 50% covered by government-sponsored programs [75] - The company anticipates that larger academic institutions, which have not yet prescribed PEDMARK, will begin to do so as they gain formulary approval [76] Company Strategy and Development Direction - The commercial strategy focuses on establishing PEDMARK as a necessary complement to cisplatin-based therapy, minimizing access barriers, and ensuring rapid responses to product inquiries [11] - The company is evaluating the best commercial pathway for Europe, considering options to go it alone or partner with other companies [81] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum building in Q2 as large centers gain formulary access and the recent issuance of a J-Code streamlines reimbursement [84] - The company is confident in its disciplined approach to building market share within the U.S. and expects significant growth as larger centers begin prescribing PEDMARK [77] Other Important Information - The FDA granted orphan drug exclusivity for PEDMARK, providing seven years of market exclusivity starting from the approval date [79] - The European Medicines Agency issued a positive opinion for PEDMARK, which is expected to be marketed as PEDMARQSI in Europe [80] Q&A Session Summary Question: What are the dynamics between Q4 and Q1 regarding revenue? - Management clarified that there were no stocking issues in either quarter and emphasized the gradual increase in revenue as larger centers gain access [91] Question: What is the expected penetration rate in the 200 centers? - Management indicated that they do not provide specific guidance but noted that they are starting to win P&T committee approvals in larger centers [94] Question: How many hospitals and prescriptions do current numbers represent? - Management discussed the bureaucratic challenges physicians face in prescribing PEDMARK and the importance of overcoming these barriers for repeat orders [45]