Financial Data and Key Metrics Changes - For the first nine months of 2024, the company recorded approximately $22 million in net product sales, surpassing all of 2023's net product sales [23] - In Q3 2024, net product sales were $7.0 million, compared to $6.5 million in the same quarter of 2023 [24] - General and administrative expenses for Q3 2024 were $6.1 million, up from $3.8 million in Q3 2023 and down from $6.9 million in Q2 2024 [24] - Selling and marketing expenses were $4.6 million in Q3 2024, compared to $4.7 million in Q2 2024 and $3.4 million in Q3 2023 [25] - The company ended Q3 2024 with approximately $40.3 million in cash, cash equivalents, and investment securities, a decrease of approximately $2 million for the quarter [26] Business Line Data and Key Metrics Changes - The company is focusing on increasing awareness and adoption of PEDMARK, particularly in the Adolescent and Young Adult (AYA) market segment, which has significant potential with at least 10,000 patients treated annually with cisplatin [11][13] - The AYA segment has achieved over 90% reimbursement for PEDMARK, indicating strong market acceptance [13] - The company has seen an increase in PEDMARK vials per patient, with some centers ordering as many as 40 vials per patient [16] Market Data and Key Metrics Changes - The AYA market is expected to be larger than the pediatric market, with favorable reimbursement profiles [11][13] - The company is expanding its market presence in Germany and the U.K. through a licensing agreement with Norgine, with product launches expected in 2025 [19] Company Strategy and Development Direction - The company aims to position PEDMARK as the standard of care for preventing cisplatin-induced ototoxicity, with strategic imperatives focused on awareness, adoption, and advocacy [9][10] - The leadership team has been strengthened with new appointments, which are expected to enhance operational efficiency and execution of the commercial strategy for PEDMARK [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of PEDMARK, particularly in the AYA market, and highlighted the importance of recent progress and new talent in driving this opportunity [32][33] - The company anticipates that its cash position will be sufficient to fund operations into at least 2026, reflecting operational efficiency and a growing revenue base [27] Other Important Information - The company is actively working on strategic initiatives to raise awareness of the risks associated with cisplatin treatment and to drive adoption of PEDMARK [18] - The investigator-initiated trial in Japan evaluating PEDMARK has been fully enrolled, with results expected in 2025 [20] Q&A Session Summary Question: Update on AYA market growth potential - Management believes the commercial opportunity for PEDMARK in the AYA market is significant and is confident in the progress made [32][33] Question: Revenue per patient and Q4 expectations - Management indicated that significant reimbursement and awareness in the AYA market provide a strong foundation for growth in Q4 [35][37] Question: Changes in purchasing behavior towards PEDMARK - There is a noticeable shift towards PEDMARK from compounded versions of sodium thiosulfate, driven by safety concerns and institutional conversations [40][41] Question: Business development priorities - The company is evaluating open territories, including Japan, and is optimistic about future business development opportunities [43] Question: Status of ongoing IP litigation - The IP litigation is ongoing, and the company has strengthened its IP portfolio significantly over the past two years [45]
Fennec Pharma(FENC) - 2024 Q3 - Earnings Call Transcript