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Ascendis Pharma(ASND) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:32
Financial Data and Key Metrics Changes - For Q2 2025, total product revenue was €153.7 million, with a negative foreign currency exchange impact of €7.6 million [27] - Skytrofa revenue for the quarter was €50.7 million, including a €1.8 million negative currency impact [27] - Eurvipath revenue more than doubled to €103 million from €44.7 million in Q1 2025, despite a negative currency headwind of €5.8 million [27] Business Line Data and Key Metrics Changes - Skytrofa continues to see growth in the number of patients treated, with Q2 revenue at €51 million [22] - The U.S. launch of Eurvipath has seen over 1,500 prescribers write prescriptions for around 3,100 unique patients [11][27] - The company expects to become cash flow positive on a quarterly basis this year [27] Market Data and Key Metrics Changes - In the U.S., the majority of patients receiving prescriptions for Eurvipath have received payer approval within three months [11] - Outside the U.S., steady revenue growth for Eurvipath is expected, with further acceleration anticipated as reimbursement becomes available in additional countries [12] Company Strategy and Development Direction - The company aims to achieve blockbuster status for multiple products and expand its innovation engine [9] - Focus on building long-term leadership in the treatment of hypoparathyroidism and growth disorders [32] - Ongoing collaboration with Novo Nordisk for the development of TransCon-based products in metabolic and cardiovascular diseases [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong global launch of Eurvipath and its potential to achieve multiple billions in peak sales [32] - The company is focused on improving patient access and reimbursement processes to enhance treatment uptake [50] - Management highlighted the importance of ongoing clinical programs to support label expansion and the potential for future growth [12][22] Other Important Information - TransCon Growth Hormone is now approved in the U.S. for adult growth hormone deficiency, with further label expansions planned [6] - The company is preparing for a Phase 3 study of combination therapy in children with achondroplasia by 2025 [22] Q&A Session Summary Question: Continuation of enrollment trends and unique patients - Management confirmed that unique patients enrolled grew from approximately 1,750 at the end of Q1 to 3,100 at the end of Q2, indicating steady state growth [36][37] Question: Improving the time from enrollment to treatment - Management acknowledged ongoing efforts to improve the time from enrollment to treatment, with expectations for improvements in the second half of the year [46][50] Question: Patient demographics and severity - Management clarified that there is no medical definition for severity in hyperparathyroidism, and they are focusing on addressing physicians who see a high number of patients [53][56] Question: Revenue expectations and patient growth - Management indicated that revenue growth in Europe is expected to continue, with a strong launch in the U.S. [61][62] Question: Conversion rates from enrollment to treatment - Management expressed that while they aim for high conversion rates, some patients may still face challenges in reimbursement [66][68] Question: Reporting enrollment forms in future quarters - Management confirmed they will continue to report necessary KPIs until a steady state is reached [70] Question: Compliance and patient retention - Management reported low discontinuation rates in Europe, indicating strong patient retention [75] Question: Titration period and costs - Management stated that the titration period is successful, but specifics on costs post-titration are still being evaluated [100][102] Question: Harmonizing U.S. and EU labels - Management is working on trials to potentially harmonize the U.S. label with the EU label for higher doses [108]
Ascendis Pharma(ASND) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Financial Data and Key Metrics Changes - Total product revenue for Q2 2025 was €153,700,000, with a negative foreign currency exchange impact of €7,600,000 [27] - Skytrofa revenue for the quarter was €50,700,000, including a €1,800,000 negative currency impact [27] - Eurvipath revenue more than doubled to €103,000,000, up from €44,700,000 in Q1 2025, despite a negative currency headwind of €5,800,000 [27] - R&D costs decreased to €72,000,000 from €83,500,000 year-over-year, while SG&A expenses increased to €107,600,000 from €74,300,000 [29] - The company ended Q2 2025 with cash and cash equivalents totaling €494,000,000, down from €518,000,000 as of March 31 [30] Business Line Data and Key Metrics Changes - Revenues for Europad in Q2 reached €103,000,000, more than double that of Q1 [10] - Skytrofa revenues were €51,000,000, with growth driven by new patient starts and recent label expansion for adult growth hormone deficiency [24] - The company expects continued revenue growth driven by the strength of the global launch of Europad [30] Market Data and Key Metrics Changes - In the U.S., over 1,500 prescribers wrote prescriptions for around 3,100 unique patients for Europad, reflecting strong demand [11] - The company has recognized revenue from more than 30 countries and has commercial agreements covering over 75 countries [15] - The U.S. launch of Europad is progressing well, with expectations for additional commercial launches in Europe and Japan [16][32] Company Strategy and Development Direction - The company aims to achieve blockbuster status for multiple products and expand its innovation engine [8] - Focus on building long-term leadership in the treatment of hypoparathyroidism and growth disorders through differentiation, demand, and access [13] - The company is preparing for future growth opportunities and ongoing collaborations with Novo Nordisk for TransCon-based products in metabolic and cardiovascular diseases [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued strong demand for Europad and the potential for it to become a blockbuster product [10] - The company anticipates becoming cash flow positive on a quarterly basis this year [29] - Management highlighted the importance of payer approvals and the ongoing efforts to improve the patient experience and access to treatment [34] Other Important Information - TransCon Growth Hormone is now approved in the U.S. for adults with growth hormone deficiency, and the company plans further label expansions [5] - The FDA granted priority review for TransCon CNP, recognizing its potential to improve treatment for achondroplasia [9] - The company is advancing new clinical data and preparing for additional key label expansions [25] Q&A Session Summary Question: Continuation of enrollment trends - Management confirmed that the number of unique patients enrolled grew to 3,100 by the end of Q2, indicating steady state growth [36][38] Question: Improving conversion from enrollment to treatment - Management acknowledged ongoing efforts to improve the time from enrollment to treatment, with expectations for better results in the second half of the year [45][49] Question: Patient demographics and severity - Management clarified that there is no medical definition for severity in hyperparathyroidism, and they are focusing on addressing physicians who see a high number of patients [53][55] Question: Future revenue expectations - Management indicated that they expect continued strong revenue growth in the U.S. and Europe, with a focus on expanding commercial launches [61][62] Question: Compliance and patient retention - Management reported low discontinuation rates in Europe, indicating strong patient retention and satisfaction with the therapy [72][73] Question: Reporting enrollment forms - Management confirmed that they will continue to report necessary KPIs related to enrollment and treatment until a steady state is achieved [69][70] Question: Titration period and costs - Management noted that the titration period is successful, but they are still assessing real-world data on costs post-titration [98][101]