Ascendis Pharma Announces Q1 2024 Financial Results
Ascendis Pharma A/S, headquartered in Copenhagen, Denmark, recently reported its financial results for the first quarter of 2024 and provided a business update. Ascendis Pharma's President and CEO, Jan Mikkelsen, highlighted significant achievements in the quarter, including a substantial increase in SKYTROFA revenue in the U.S. and the successful initial roll-out of YORVIPATH in Germany and Austria. These developments, according to Mikkelsen, position the company for sustainable growth and operating cash flow breakeven by late 2024.
Key Highlights and Future Milestones
TransCon hGH (SKYTROFA):
- First-quarter 2024 SKYTROFA revenue reached €65 million, marking a 106% year-over-year increase.
- Ascendis anticipates full-year 2024 SKYTROFA revenue to be between €320 million and €340 million.
- Plans include submitting a supplemental Biologics License Application to the FDA for adult growth hormone deficiency in Q3 2024.
- Topline results from a Phase 2 trial in Turner syndrome are expected in Q4 2024.
TransCon PTH (YORVIPATH):
- The commercial rollout of YORVIPATH in Germany and Austria saw around 55 doctors writing prescriptions and approximately 100 patients receiving the product by March 31.
- First-quarter YORVIPATH revenue amounted to €1.5 million, reflecting its initial market delivery phase.
- In the U.S., the Prescription Drug User Fee Act (PDUFA) date is scheduled for May 14, 2024. If approved, the U.S. commercial launch is set for Q3 2024.
- YORVIPATH has received marketing authorization and orphan drug status in Great Britain for treating adults with chronic hypoparathyroidism.
TransCon CNP:
- Topline data from the pivotal ApproaCH Trial is anticipated in Q4 2024. Following this, a New Drug Application for children with achondroplasia is planned.
- The company expects to complete enrollment for the TransCon hGH and TransCon CNP COACH trial by Q2 2024, with Week 26 topline data expected by Q4 2024.
Oncology Programs:
- New data from the ongoing Phase 1/2 IL-Believe Trial will be presented at the American Society for Clinical Oncology (ASCO) between May 31 and June 4, highlighting initial data from a combination of TransCon IL-2 β/γ and TransCon TLR7/8 Agonists in melanoma patients.
- A clinical update on Phase 2 expansion cohorts for TransCon IL-2 β/γ and TransCon TLR7/8 Agonist trials is planned for Q4 2024.
Financial Overview
Q1 2024 Financial Results:
- Total revenue for Q1 2024 was €95.9 million, a significant increase from €33.6 million in Q1 2023. The rise was primarily due to higher SKYTROFA revenue and non-cash license revenue from a deal with Eyconis.
- Research and development (R&D) expenses dropped to €70.7 million from €106.1 million in Q1 2023.
- Selling, general, and administrative (SG&A) expenses were €66.8 million, slightly up from €66.5 million in Q1 2023.
- Total operating expenses for Q1 2024 were €137.5 million, down from €172.7 million in Q1 2023.
- Net finance expenses rose to €73.6 million compared to net finance income of €35.3 million in Q1 2023.
- The net loss for Q1 2024 was €131.0 million, or €2.30 per share, compared to a net loss of €110.9 million, or €1.98 per share, in Q1 2023.
- Ascendis Pharma's cash, cash equivalents, and marketable securities totaled €320.2 million as of March 31, 2024, down from €399.4 million as of December 31, 2023.
Future Outlook
Ascendis Pharma remains on track to achieve its full-year 2024 SKYTROFA revenue target of €320 million to €340 million. The company expects total operating expenses for 2024 to be around €600 million and aims to achieve operating cash flow breakeven on a quarterly basis by the end of 2024.
Ascendis Pharma continues to leverage its innovative TransCon technology platform to develop treatments in endocrinology rare diseases and expand into larger therapeutic areas such as oncology, ophthalmology, and metabolic diseases. With a robust pipeline and strategic goals outlined in Vision 2030, the company is poised for significant growth and development in the coming years.
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