Core Insights - Fennec Pharmaceuticals reported total net revenues of $9.7 million for Q2 2025, reflecting a 33% increase compared to the same quarter in 2024, driven by growth in large community practices and academic centers [1][3][9] - The company has seen a successful uptake of its product PEDMARQSI in the UK and Germany, with plans for additional EU launches [1][3] - The management anticipates results from a clinical trial in Japan (STS-J01) in the second half of 2025, which may lead to registration and potential licensing opportunities [1][3] Financial Performance - Net product sales for Q2 2025 were approximately $9.7 million, up from $7.3 million in Q2 2024, attributed to growth in the adolescent and young adult (AYA) population [9][11] - Selling and marketing expenses decreased to $4.4 million in Q2 2025 from $4.6 million in Q2 2024, while general and administrative expenses increased slightly to $7.0 million from $6.9 million [9][11] - The company reported a net loss of $3.2 million for Q2 2025, compared to a net loss of $5.6 million in Q2 2024 [11] Business Highlights - Fennec's segmentation model and data-driven targeting have led to significant growth in both new and repeat customers, particularly in large community and academic practices [6] - A large national oncology group has added PEDMARK to its formulary for patients under 40, indicating growing recognition of the need to protect younger patients from cisplatin-induced hearing loss [6] - The NCODA PQI issued for PEDMARK aims to provide clinical data and guidance for healthcare professionals managing patients on cancer therapies [6] Upcoming Events - Fennec will ring the NASDAQ closing bell on September 5, 2025, alongside PEDMARK patients and their families [10] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City [10] Product Information - PEDMARK is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients [15][19] - The product has received Orphan Drug Exclusivity in the U.S. and is commercially available in the U.K. and Germany under the brand name PEDMARQSI [28][30]

Core Insights - Fennec Pharmaceuticals reported first quarter 2025 total net revenues of $8.8 million, representing an 18% increase year over year from $7.4 million in the first quarter of 2024 [1][5][10] - The company has successfully launched PEDMARQSI in Germany and the United Kingdom, enhancing access to its product for cancer patients at risk of hearing loss [1][6][29] - The revamped Fennec HEARS™ patient support program aims to improve the experience for adolescent and young adult cancer patients [2][6] Financial Results - Net product sales for the first quarter of 2025 were approximately $8.8 million, up from $7.4 million in the same period last year [5][10] - Total revenue for the first quarter was $8.8 million, with no licensing revenue recorded compared to $17.96 million in the first quarter of 2024 [10] - Operating expenses totaled $9.56 million, down from $11.63 million in the previous year, with selling and marketing expenses decreasing to $2.95 million from $5.21 million [11][10] Business Highlights - The company has strengthened its segmentation model and data-driven target lists, leading to the addition of multiple new accounts across academic and community providers [6][7] - The commercial launch of PEDMARQSI in Europe marks a significant step in expanding access to the product [6][29] - Fennec will participate in the ASCO 2025 Annual Meeting and other investor conferences, indicating ongoing engagement with the medical and investment communities [6][4] Upcoming Events - Fennec will host a conference call on May 13, 2025, at 8:30 a.m. ET to discuss its financial results and business updates [1][8] - The Annual General Meeting is scheduled for June 3, 2025, in New York, providing an opportunity for shareholder engagement [6][4]

Core Viewpoint - Fennec Pharmaceuticals Inc. is set to release its first quarter 2025 financial results on May 13, 2025, and will host a conference call to discuss these results [1] Group 1: Financial Results Announcement - The company will announce its first quarter 2025 financial results before the U.S. financial markets open on May 13, 2025 [1] - A conference call and webcast will be held on the same day to discuss the financial and business results [1] Group 2: Conference Call & Webcast Details - The conference call is scheduled for 8:30 a.m. ET on May 13, 2025 [2] - Links for the webcast and participant registration are provided, with a recommendation to connect at least 15 minutes prior to the call [2] Group 3: Company Overview - Fennec Pharmaceuticals focuses on developing and commercializing PEDMARK, aimed at reducing platinum-induced ototoxicity in pediatric patients [3] - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI [3] - The product has Orphan Drug Exclusivity in the U.S. and Pediatric Use Marketing Authorization in Europe, providing significant market protection [3]

Financial Data and Key Metrics Changes - In 2024, the company reported a revenue growth of approximately 40% year-over-year, with net product sales of $29.6 million compared to $21.3 million in 2023 [28][30] - For Q4 2024, net product sales were $7.9 million, reflecting a quarterly growth rate of approximately 13% [28] - The company managed to burn only approximately $0.6 million in cash for Q4 2024, demonstrating operational efficiency [34] Business Line Data and Key Metrics Changes - The pediatric segment continued to show growth, while the adolescent and young adult (AYA) segment emerged as a significant opportunity [38] - Selling and marketing expenses for Q4 2024 were $3.9 million, down from $4.6 million in Q3 2024, while full-year expenses increased to $18.4 million from $12.1 million in 2023 [29][30] Market Data and Key Metrics Changes - The U.S. AYA oncology landscape is estimated to have approximately 20,000 cisplatin chemotherapy patients treated annually, with significant market potential [11][12] - The product PEDMARK is gaining traction in major academic centers, which is critical for broader market acceptance [14] Company Strategy and Development Direction - The company is focused on expanding awareness of the unmet need for preventing cisplatin-induced ototoxicity and establishing PEDMARK as the standard of care [9][10] - The PEDMARK strategy will be utilized throughout 2025 to drive growth, with a focus on both pediatric and AYA populations [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential for 2025, particularly in the second half of the year as foundational initiatives take effect [29][41] - The company anticipates additional compendia listings and is actively engaging with stakeholders to support positive outcomes for PEDMARK's inclusion in guidelines [17][18] Other Important Information - The company has launched PEDMARQSI in Germany and the U.K., with pricing set at £8277 in the U.K. and over €10,500 per vial in Germany [20][21] - The company reported a cash position of $26.6 million as of December 31, 2024, following a significant debt repayment [33] Q&A Session Summary Question: Did the pediatric business return to sequential growth in Q4, and what was the AYA contribution? - Management confirmed continued growth in the pediatric segment and highlighted the AYA segment as an incredible opportunity, though specific breakdowns were not provided [38] Question: What is the expected inflection in the AYA segment for 2025? - Management indicated significant opportunities in the AYA segment and expected accelerated growth in the second half of 2025 [41] Question: What progress has Norgine made in Europe? - Management noted that the product is commercially available in the U.K. and Germany, with ongoing updates expected as more countries get approved [48][49] Question: What is the competitive landscape for PEDMARK in the U.S.? - Management acknowledged the presence of compounded products but emphasized the adoption of PEDMARK in major institutions, indicating progress despite competition [72] Question: Will clinical trials be run for potential label expansions? - Management indicated openness to discussions regarding label expansions and will provide updates as developments occur [75] Question: How does the company prioritize commercial efforts between community centers and academic institutions? - Management emphasized the importance of both settings and noted that awareness levels in the AYA space present a significant opportunity for growth [90]

Core Insights - Fennec Pharmaceuticals reported a significant increase in net product sales for PEDMARK, achieving $29.6 million for the full fiscal year 2024, which is a 40% increase year-over-year, and $7.9 million in Q4 2024, reflecting a 13% increase from the previous quarter [1][11][32] - The company has strengthened its leadership team and is focused on expanding the adoption of PEDMARK in academic institutions and new patient segments, particularly in the adolescent and young adult (AYA) market [3][32] - Fennec has successfully launched PEDMARQSI in the UK and Germany, enhancing global access to its product aimed at preventing cisplatin-induced hearing loss in pediatric patients [1][6][32] Financial Performance - For the fiscal year 2024, total revenue reached $47.5 million, with net product sales contributing $29.6 million, compared to $21.3 million in 2023 [11][12] - The company reported a cash position of $26.6 million as of December 31, 2024, with a notable increase in cash and cash equivalents of $13.4 million from the previous year [11][14] - Selling and marketing expenses increased to $18.4 million for FY 2024, up from $12.1 million in FY 2023, reflecting the company's efforts to expand outreach [11][12] Strategic Developments - Fennec completed an early repayment of $13 million of its convertible debt facility, optimizing its balance sheet and saving approximately $1.5 million in future interest payments [1][6] - The company is advancing its efforts to include PEDMARK in the NCCN Drug and Biologics Compendium, which is crucial for expanding access and reimbursement pathways [6][32] - A clinical trial in Japan (STS-J01) is fully enrolled, with results expected in the second half of 2025, potentially leading to registration of PEDMARK in Japan [1][6]