Ascendis Pharma(ASND) - 2024 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Product revenues have significantly increased, with SKYTROFA volume rising over 60% year-over-year in Q3 2024, although reported revenue was EUR 47.2 million compared to EUR 47 million in Q3 2023 due to higher sales deductions [32][34] - Total revenue for Q3 was EUR 57.8 million, including EUR 2.1 million from services and license revenue [37] - Cash, cash equivalents, and marketable securities totaled EUR 626 million at the end of Q3 2024, up from EUR 399 million at the end of 2023 [41] Business Line Data and Key Metrics Changes - SKYTROFA's revenue for the first nine months of 2024 totaled EUR 138.5 million, a 21% increase year-over-year [34] - YORVIPATH revenue outside the US increased over 60% to EUR 8.5 million in Q3, driven by growing demand [36] - The company expects full-year 2024 SKYTROFA revenue to be between EUR 200 million and EUR 220 million, excluding prior year sales deductions [42] Market Data and Key Metrics Changes - SKYTROFA penetration in the overall treated growth hormone market was approximately 6% by the end of Q3 2024, with daily growth hormone products representing about 85% of total US prescriptions [35] - The market for YORVIPATH is estimated to have around 70,000 to 90,000 adults with hypoparathyroidism in the US [10] Company Strategy and Development Direction - The company aims to expand SKYTROFA's label to include adult growth hormone deficiency and to successfully launch YORVIPATH in the US and Europe [31] - A new partnership with Novo Nordisk is expected to enhance the TransCon technology platform, targeting obesity and type 2 diabetes [24][25] - The company is focused on achieving blockbuster status for its endocrinology programs and expanding its market share [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining patient retention for YORVIPATH due to its unique therapeutic profile and alignment with treatment guidelines [44][60] - The goal of achieving operating cash flow breakeven by the end of 2025 remains intact, supported by current cash reserves [48] - Management highlighted the strong position of SKYTROFA in a consolidating market, with expectations for continued growth [15][56] Other Important Information - The company has a robust supply chain for YORVIPATH, ensuring no patient will be unable to receive their prescription [111] - The company is preparing for the imminent launch of YORVIPATH in the US, with product availability expected in mid-January 2025 [16][42] Q&A Session Summary Question: Confidence in retaining patients for YORVIPATH amid competition - Management emphasized the unique replacement therapy characteristics of YORVIPATH, which are unmatched by competitors [44][45] Question: Expectation to reach operating cash flow breakeven by end of 2025 - Management confirmed that this remains the goal, supported by current cash and equivalents [48] Question: Update on CNP preparation for FDA meeting - Management stated that all necessary data for the submission is ready, with no missing information [51][52] Question: Progress with payers for SKYTROFA approval - Management indicated improvements in market access and a strong positioning strategy for SKYTROFA [55][56] Question: Timing for NATPARA inventory depletion affecting YORVIPATH - Management noted that the timing is outside their control but expects a transition to occur next year [65][66] Question: Uptake of PTH experienced patients onto YORVIPATH - Management believes that many patients will seek treatment quickly once YORVIPATH is available [71][72] Question: Revenue contribution from adult growth hormone market - Management highlighted the potential for significant growth in the adult market, which is currently underpenetrated [75][76] Question: Comparison of YORVIPATH launch in the US versus Europe - Management expects a faster uptake in the US due to a more unified market mindset [81][82] Question: Adjustments to 2024 revenue guidance for SKYTROFA - Management explained that lower volume and fewer selling days contributed to the adjustments [84] Question: Next milestones for oncology pipeline - Management expressed encouragement from recent results and plans to focus on creating value for patients [92]