Ascendis Pharma(ASND) - 2020 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a net loss of €63.3 million or €1.32 per share for Q1 2020, compared to a net loss of €53.6 million or €1.24 per share in Q1 2019, indicating an increase in loss year-over-year [22] - Research and development costs increased to €57.5 million in Q1 2020 from €51.3 million in Q1 2019, driven by higher personnel-related costs and oncology area build-out [22] - General and administrative expenses rose to €17.9 million in Q1 2020 from €10.4 million in Q1 2019, primarily due to increased personnel costs [23] Business Line Data and Key Metrics Changes - For TransCon PTH and TransCon CNP, costs remained relatively flat, with higher clinical trial costs offset by lower manufacturing costs [22] - Costs for TransCon growth hormone were lower compared to the same period last year due to reduced payments and activities related to validation batch preparations [22] Market Data and Key Metrics Changes - The company is on track to submit a Biologics License Application (BLA) in the U.S. in Q2 2020 and a Marketing Authorization Application (MAA) in Europe in Q3 2020 for TransCon growth hormone [23] - The company plans to initiate a Phase 3 trial for pediatric growth hormone deficiency in Japan in Q4 2020 and enroll subjects in the foresiGHt Trial for adult growth hormone deficiency [23] Company Strategy and Development Direction - The company aims to build a fully integrated biopharma company with a diverse pipeline of high-value product candidates across multiple therapeutic areas [25] - The Vision 3x3 strategic roadmap focuses on creating sustainable growth through global clinical REITS and pursuing new indications [10] - The company is preparing for the potential launch of TransCon growth hormone and has appointed Jesper Høiland as Global Chief Commercial Officer to strengthen its commercial capabilities [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in executing strategic goals despite the COVID-19 situation, noting that operations in Denmark and Germany have resumed [8] - The company is engaging with regulatory authorities for next steps, including preparing for an end of Phase 2 meeting for TransCon PTH [19] - Management highlighted the potential of TransCon PTH as a true hormone replacement therapy for hypoparathyroidism, aiming to improve patient quality of life [15][18] Other Important Information - The company has received orphan drug designation in both the U.S. and Europe for TransCon growth hormone, recognizing the need for long-acting growth hormone therapy [14] - The company is advancing multiple oncology programs and plans to submit its first IND for the TransCon TLR 7/8 agonist program in Q4 2020 [20][24] Q&A Session Summary Question: Can you provide insights on the oncology platform and the characteristics of the PLR molecule? - Management emphasized the importance of building a pipeline of oncology products, with plans to advance multiple candidates, including TransCon TLR 7/8 and a bias IL-2 compound [26][28] Question: What feedback are you receiving from investigators on TransCon PTH? - Management reported positive feedback from investigators, noting high retention rates in the trial and the transformative potential of TransCon PTH for patients [31] Question: What are the main barriers to making TransCon growth hormone a commercial success? - Management indicated that Jesper Høiland will provide insights on commercialization strategies during the next earnings call, leveraging his extensive experience in the growth hormone market [52] Question: How is the company managing the impact of COVID-19 on the launch strategy? - Management stated that they are adapting to changing circumstances and are committed to ensuring a successful launch of TransCon growth hormone [60] Question: Can you provide an update on the ACcomplisH trial for TransCon CNP? - Management confirmed that they are on track to initiate a second Phase 2 trial in China and are conducting safety and efficacy meetings for dose escalation [55][68]