Ascendis Pharma(US:ASND)2023-04-28 02:34Financial Data and Key Metrics Changes - SKYTROFA revenue for Q1 2023 was €31.6 million, with total revenue reaching €33.6 million, including other services [18][19] - Operating loss for Q1 2023 decreased by 3% sequentially to €144 million from €147 million in Q4 2022 [19] - Cash, cash equivalents, and marketable securities totaled €586 million at the end of Q1 2023 [20] Business Line Data and Key Metrics Changes - SKYTROFA revenue is projected to reach between €150 million and €160 million for the full year 2023, based on Q1 performance and patient addition goals [13][20] - The company is on track to launch SKYTROFA in Germany in Q3 2023 and expects top-line results from the Phase 3 foresiGHt trial in adult growth hormone deficiency in Q4 2023 [21] Market Data and Key Metrics Changes - The U.S. market for growth hormone is experiencing consolidation, with daily growth hormone companies reducing investment as they phase out existing products [12][14] - The company anticipates that the current supply challenges of daily growth hormone products will further support the uptake of SKYTROFA [12] Company Strategy and Development Direction - The company is focused on executing its Vision 3x3 strategy to build a sustainable and profitable biopharma company [9] - Ascendis Pharma aims to expand its geographic and label reach for SKYTROFA while also advancing TransCon PTH and TransCon CNP in their respective markets [14][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the approval of TransCon PTH, citing positive clinical data and feedback from patients and physicians [9] - The company is managing its business for long-term value creation and aims to achieve cash flow break-even without additional dilutive equity financing [17][20] Other Important Information - The company is preparing for an R&D event focused on oncology in May 2023, where updates on TransCon TLR7/8 agonist and TransCon IL-2 beta/gamma will be shared [17][22] - The open-label extension of the Phase 2 path forward and Phase 3 PaTHway trials for TransCon PTH continues, with a significant number of original trial patients still on treatment [15] Q&A Session Summary Question: Can you comment on the deficiencies that the FDA has regarding the PTH NDA? - Management stated they cannot comment on the deficiencies and have no further comments [24] Question: What are your expectations for PTH that are embedded in the breakeven assumption? - Management indicated they are considering various scenarios and expect to launch SKYTROFA in Germany and TransCon PTH in early 2024 [26] Question: What changed during the quarter to make you confident in your sales guidance? - Management expressed confidence based on solid Q1 sales data and the experience with SKYTROFA, stating they are not losing patients [29] Question: How should we look at SKYTROFA growth in the U.S. versus Europe? - Management clarified that the guidance provided reflects only U.S. sales, with European sales expected to be additional [32] Question: Can you provide guidance on OpEx going forward? - Management emphasized a focus on optimizing business operations and maintaining a solid financial position without needing to increase expenses significantly [42][45] Question: What is the competitive landscape for TransCon CNP? - Management highlighted the potential for TransCon CNP to address not only linear growth but also comorbidities associated with achondroplasia [69]