Financial Data and Key Metrics Changes - The company reported net product sales of $9.7 million for Q2 2025, representing a 33% increase year-over-year and a 10% increase sequentially, marking the highest quarterly net product sales in the company's history [14][20][24] - Total cash operating expenses for the quarter were approximately $11 million, an increase of roughly $2 million compared to Q1 2025, driven by ongoing investments in marketing and additional headcount [22][24] Business Line Data and Key Metrics Changes - The company achieved three consecutive quarters of growth in Pedmark sales, with the addition of 14 new accounts in Q2, including large community oncology groups [15][20] - The company is focused on establishing Pedmark as the standard of care for cisplatin-induced ototoxicity (CIO) prevention, with positive feedback from existing accounts strengthening confidence in clinical value [10][11] Market Data and Key Metrics Changes - The AYA (adolescent and young adult) market is identified as significantly larger than the pediatric market, with approximately 20,000 patients treated with cisplatin in that demographic [31] - The company is seeing strong momentum in both large community practices and academic centers, indicating a growing recognition of the need for Pedmark [9][10] Company Strategy and Development Direction - The company aims to stabilize the business and build a foundation for sustainable growth, focusing on increasing awareness and adoption of Pedmark [6][8] - The strategic imperatives include enhancing patient support services, cementing Pedmark as the standard of care, and expanding educational efforts beyond oncologists to other healthcare professionals [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the scalability of the business model and the growing demand for Pedmark, anticipating significant quarterly growth in 2025 [20][21] - The company is optimistic about the partnership with Norgene in the EU, expecting to provide updates on milestones and royalties in future quarters [21][40] Other Important Information - The company has made significant progress with payers and providers to ensure smoother coverage and fewer barriers for treatment sites [12] - The company plans to ring the closing bell at NASDAQ on September 5, 2025, symbolizing its mission to help patients [14] Q&A Session Summary Question: Can you share the active prescribers number, particularly within AYA? - The company does not disclose cumulative active prescriber numbers but acknowledges the importance of protecting relationships with accounts [28][30] Question: What is the mix of new and repeat customers? - Initially, the company focused on new customers, but there is now a shift towards a higher percentage of repeat customers as the business grows [44][46] Question: Can you elaborate on the Japanese market opportunity? - Japan represents about a third of the size of the U.S. and Europe in terms of CIO usage, with ongoing discussions about regulatory approaches and potential partnerships [49][50] Question: What are the expectations for operating expenses in the second half of the year? - The company expects cash operating expenses to decrease in the second half of the year, consistent with previous years [55][56] Question: How proactive has the FDA been regarding compliance with guidance on Pedmark? - The FDA has been supportive of the use of Pedmark and continues to emphasize its status as the only FDA-approved product for preventing cisplatin-induced hearing loss [70][71] Question: What is the timeline for the Norgene partnership in the EU? - The Norgene partnership has launched in the UK and is expected to expand to other EU markets early next year, with significant enthusiasm for the product [74][75]

Financial Data and Key Metrics Changes - The company reported $8.8 million in top-line revenue for the most recent quarter, showing growth from $8 million in the previous quarter [40][41] - To achieve cash flow breakeven, the company needs to reach a normalized revenue run rate of approximately $8.5 million to $9 million per quarter, aligning with annual cash operating expenses of roughly $33 million to $35 million [41][42] Business Line Data and Key Metrics Changes - The product Pedmark, sodium thiosulfate, is the first FDA-approved treatment for ototoxicity risk due to cisplatin in pediatric patients, with recent NCCN guidelines expanding its recommendation to patients aged 15 to 39 [5][6] - The company has seen two consecutive quarters of growth, attributed to improved marketing strategies and a focus on the adolescent and young adult (AYA) population [16][22] Market Data and Key Metrics Changes - The AYA segment presents a significant market opportunity, with approximately 20,000 patients in the AYA space receiving cisplatin, compared to about 3,000 pediatric patients [17][18] - The partnership with Norgene for European markets includes an upfront fee of approximately $43 million and royalties starting in the mid-teens, with potential milestones exceeding $200 million [44][45] Company Strategy and Development Direction - The company aims to enhance its commercial execution and has focused on increasing the competency of its medical team to engage with key opinion leaders [23][25] - Future growth strategies include targeting high prescribers of cisplatin and potentially introducing additional complementary products in oncology supportive care [56][58] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of increasing awareness of Pedmark among prescribers and improving execution in sales and marketing efforts [35][36] - The company is optimistic about achieving profitability and is exploring opportunities in Japan, where a trial for Pedmark has been completed and is under review [58][59] Other Important Information - The company has approximately $23 million in cash as of March 31, with a convertible note of $19.5 million remaining, which they plan to address as profitability increases [50][51] - Recent approvals for Pedmark in Scotland and ongoing efforts to expand into additional EU countries are part of the company's growth strategy [48][47] Q&A Session Summary Question: What is the revenue run rate needed for cash flow breakeven? - The company needs to achieve a revenue run rate of approximately $8.5 million to $9 million per quarter to reach cash flow breakeven [41][42] Question: Can you describe the partnership with Norgene? - The partnership includes an upfront fee of approximately $43 million, royalties starting in the mid-teens, and potential milestones exceeding $200 million [44][45] Question: What are the plans regarding the convertible debt? - The company has retired $13 million of the convertible note, which currently stands at $19.5 million, and plans to explore options for further retirement as profitability improves [51][52]

Financial Data and Key Metrics Changes - The company recorded net product sales of approximately $8.8 million in Q1 2025, reflecting an 18% growth compared to $7.4 million in Q1 2024 and an 11% increase over Q4 2024 [16][17] - Selling and marketing expenses decreased to $2.9 million in Q1 2025 from $5.2 million in Q1 2024, primarily due to the elimination of European pre-commercialization expenses [17] - General and administrative expenses were $6.1 million in Q1 2025, consistent year-over-year but increased from $4.1 million in Q4 2024 [18] - Cash and cash equivalents stood at $22.6 million as of March 31, 2025, with a cash burn of approximately $4 million in Q1 2025 [18] Business Line Data and Key Metrics Changes - The company focused on enhancing field execution and supporting sustainable growth across key PedMark segments, particularly expanding into the adolescent and young adult (AYA) patient population [5][6] - The targeting model implemented in Q1 2025 allowed for better engagement with high-volume cisplatin prescribers, leading to early traction in key accounts [7][8] - The AYA segment is estimated to have a market potential greater than the pediatric market, with approximately 20,000 cisplatin chemotherapy patients treated annually in the U.S. [9] Market Data and Key Metrics Changes - The product Pedmark has launched commercially in Germany and the UK, with recent acceptance for use in Scotland [12] - The investigator-initiated trial in Japan evaluating Pedmark was fully enrolled as of October 2024, with results expected in the second half of 2025 [13] Company Strategy and Development Direction - The company aims to deepen relationships with key accounts and expand adoption with existing customers while generating evidence-based data through investigator-sponsored trials [14] - A focus on enhancing the FENIC HEAR's patient support program is intended to improve access and streamline reimbursement processes [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving significant quarterly growth in 2025, particularly in Q2 and Q3, as foundational initiatives take effect [17][19] - The company does not anticipate proposed tariffs to materially impact gross margins or overall financial performance [19] Other Important Information - The company is focused on increasing patient adherence through the PhenicHERS program, which has been redesigned to support home administration of the product [24][27] - Management is exploring strategic opportunities in oncology supportive care, with potential synergies identified [69] Q&A Session Summary Question: Average number of vials per patient in the AYA segment - The average is about 30 vials per patient, with approximately 50% adherence to the full treatment course [22][24] Question: Capabilities driving adherence improvement in the PhenicHERS program - The program has been redesigned to focus on home administration and patient education to improve adherence [25][27] Question: Operating expenses and future revenue growth expectations - Operating expenses are front-end loaded, with expectations for a decrease in the second half of the year, aiming for revenue growth to reach breakeven [29][49] Question: Initial inroads into the AYA settings - The company is making progress in both NCI centers and community settings, with a focus on large academic centers and community practices [57] Question: Future opportunities for Pedmark in ex-U.S. territories - The company is targeting Spain, Italy, and France for future introductions of Pedmark, following recent launches in Germany and the UK [66] Question: Strategic opportunities in oncology supportive care - The company is open to exploring strategic opportunities as sales grow and the organization stabilizes [69]

Financial Data and Key Metrics Changes - The company recorded net product sales of approximately $8.8 million in Q1 2025, reflecting an 18% growth compared to $7.4 million in Q1 2024 and an 11% increase over Q4 2024 [15][16] - Selling and marketing expenses decreased to $2.9 million in Q1 2025 from $5.2 million in Q1 2024, primarily due to the elimination of European pre-commercialization expenses [17] - General and administrative expenses were $6.1 million in Q1 2025, consistent year-over-year but increased from $4.1 million in Q4 2024 [18] - Cash and cash equivalents stood at $22.6 million as of March 31, 2025, with a cash burn of approximately $4 million in Q1 2025 [18] Business Line Data and Key Metrics Changes - The company has made significant progress in targeting prescribers for Pedmark, particularly in the adolescent and young adult (AYA) patient population, which is expected to have a larger market potential than the pediatric market [9][10] - The targeting model implemented has shown early traction, with tier one targets prescribing Pedmark and integrating it into treatment plans [7][10] Market Data and Key Metrics Changes - The AYA segment is estimated to have approximately 20,000 cisplatin chemotherapy patients treated annually in the U.S., with a favorable reimbursement profile [9] - The product has launched commercially in Germany and the UK, with recent acceptance for use in Scotland [12] Company Strategy and Development Direction - The company is focused on enhancing field execution and supporting sustainable growth across key segments, particularly through a data-driven targeting model [5][6] - There is a strategic emphasis on deepening relationships with key accounts and expanding adoption among existing customers [14] - The company is exploring additional strategic opportunities in oncology supportive care, with ongoing discussions about potential synergies [66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, anticipating significant quarterly growth in net product sales as foundational initiatives take effect [17] - The company remains optimistic about the impact of its strategic focus and disciplined execution, expecting continued progress throughout the year [14][71] Other Important Information - The company does not anticipate that proposed tariffs will materially impact gross margins or overall financial performance, as Pedmark is manufactured in the U.S. [19] Q&A Session Summary Question: Average number of vials per patient and adherence rates - The average is about 30 vials per patient, with approximately 50% adherence to the full treatment course [21][23] Question: Improvements in the FENICHERS program - The program has been redesigned to enhance home administration capabilities, which is critical for improving adherence [26][27] Question: Operating expenses and future revenue expectations - Operating expenses are expected to be front-end loaded, with a potential decrease in the second half of the year [30][31] - The company aims for revenue growth to reach breakeven, targeting approximately $8.5 to $9 million in sales [47][48] Question: Expansion into ex-U.S. markets - The company is focusing on major European markets, with Spain, Italy, and France as potential future opportunities for Pedmark [62][63] Question: Strategic opportunities in oncology supportive care - The company is open to exploring strategic opportunities and partnerships that could enhance its offerings in supportive care [66]