
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]