Ascendis Pharma(ASND) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Ascendis Pharma reported a significant increase in first quarter revenue for Europath, reaching €44.7 million, up from €13.6 million in the previous quarter [28] - Total revenue for the first quarter was €101 million, which includes non-product revenue from collaboration partners [30] - R&D costs for the first quarter totaled €86.6 million, compared to €70.7 million in the same quarter of the previous year [30] - SG&A expenses increased to €101 million from €66.8 million year-over-year, primarily due to global commercial expansion [31] Business Line Data and Key Metrics Changes - Europath's first quarter global revenue grew to €45 million, reflecting strong U.S. demand and a growing patient base [13][28] - Skytrofa revenue for the quarter was €51.3 million, with stable pricing and market share, although impacted by seasonal dynamics [29][18] - The company expects Europath to significantly contribute to revenue in 2025, with ongoing growth in both U.S. and international markets [16][28] Market Data and Key Metrics Changes - As of March 31, Europath was prescribed by over 1,000 unique prescribers for more than 1,750 patients in the U.S. [11] - The company estimates over 400,000 patients globally and around 70,000 in the U.S. are living with chronic hypoparathyroidism, with a significant portion being candidates for treatment with Europath [17] - Skytrofa holds approximately 7% market share in the total growth hormone market in the U.S. and around 43% in the non-active growth hormone market [18] Company Strategy and Development Direction - Ascendis Pharma aims to be a leading biopharma company, focusing on the global launch of Europath and the development of TransCon CNP for growth disorders [10][12] - The company is committed to expanding its product portfolio and addressing unmet medical needs in endocrinology and rare diseases [25] - Ascendis Pharma plans to submit an MAA for TransCon CNP in the EU in Q3 2025, with ongoing clinical trials to support its growth strategy [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong launch performance of Europath and its potential to become a multi-billion euro product [17] - The company anticipates substantial revenue growth driven by the global launch of Europath and continued contributions from Skytrofa [32] - Management highlighted the importance of favorable reimbursement dynamics and ongoing patient adherence as key factors for future success [41][42] Other Important Information - Ascendis Pharma recognized a non-cash gain of €33.6 million from its share of profit loss of associates due to the Visa IPO [31] - The company ended the first quarter with cash and cash equivalents totaling €518 million, down from €560 million at the end of 2024 [32] Q&A Session Summary Question: Expectations for reimbursement of Yorvapath - Management estimates that 17% to 18% of patients prescribed Yorvapath will ultimately get reimbursed, with ongoing positive trends in payer policies [39][40] Question: Split between U.S. and ex-U.S. revenue for Yorvapath - Management indicated steady growth in ex-U.S. markets, with expectations for acceleration in the second half of the year as more countries achieve full reimbursement [48] Question: Status of negotiations with commercial payers - Conversations with payers have been positive, with multiple favorable policies in place, and the company expects to continue gaining traction [54] Question: Proportion of new prescriptions from NATPARA or PTH naive patients - The majority of new patients are coming from conventional therapy, with about 10% to 15% having been on some form of PTH previously [58][62] Question: Depth of prescribing for Yorvapath - Management noted that they cannot definitively categorize patients as well-controlled or uncontrolled, but they are focusing on those frequently seeing endocrinologists [66][70] Question: Feedback on the titration process for Yorvapath - Adherence rates are consistent with clinical trials, and dropout rates are under 1%, indicating strong patient retention [100][101] Question: Plans for clinical utility trials for milder patients - Management is evaluating the long-term benefits of treatment for society and considering how to demonstrate the economic value of Yorvapath [108]