• Total Revenue: EUR101 million for the first quarter.
• YORVIPATH Revenue: EUR44.7 million in Q1, up from EUR13.6 million in Q4 2024.
• SKYTROFA Revenue: EUR51.3 million for the quarter.
• R&D Expenses: EUR86.6 million in Q1 2025, compared to EUR70.7 million in Q1 2024.
• SG&A Expenses: EUR101 million in Q1 2025, up from EUR66.8 million in Q1 2024.
• Total Operating Expenses: EUR188 million for the first quarter of 2025.
• Net Finance Expenses: EUR15.9 million for Q1 2025.
• Net Cash Financial Income: EUR3.3 million for Q1 2025.
• Cash and Cash Equivalents: EUR518 million as of March 31, 2025.

• Warning! GuruFocus has detected 4 Warning Sign with ASND.

Release Date: May 01, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Ascendis Pharma AS (NASDAQ:ASND) reported strong revenue growth for YORVIPATH, with first-quarter revenue increasing significantly to EUR 44.7 million, driven by a successful US launch.
• SKYTROFA achieved EUR 51 million in revenue for Q1, maintaining a stable market share and pricing, with expectations for continued growth.
• The company has made significant progress in regulatory approvals, with TransCon PTH approved in the US and Europe for hypoparathyroidism, and TransCon CNP submitted for FDA review.
• YORVIPATH has been prescribed by over 1,000 unique healthcare providers in the US, indicating strong market penetration and acceptance.
• Ascendis Pharma AS (NASDAQ:ASND) is on track to become cash flow positive, supported by a growing revenue base and strategic product launches.

Negative Points

• R&D expenses increased to EUR 86.6 million in Q1, up from EUR 70.7 million in the same period last year, impacting overall profitability.
• SG&A expenses rose significantly to EUR 101 million, primarily due to global commercial expansion, which may pressure margins.
• The company faces challenges in achieving 100% reimbursement approval for YORVIPATH, with expectations of 70-80% reimbursement success.
• Revenue for SKYTROFA in the US was negatively impacted by seasonal factors, including channel inventory reductions and higher co-pay assistance.
• The company is not providing specific revenue guidance for SKYTROFA or YORVIPATH, creating uncertainty for investors regarding future financial performance.

Q & A Highlights

Q: Can you discuss your expectations for the proportion of patients who will ultimately get reimbursed for YORVIPATH once it reaches a steady state? A: Jan Moller Mikkelsen, CEO, mentioned that while it's difficult to predict exact numbers, they are optimistic about achieving a 70% to 80% reimbursement rate. Jay Wu, President of Ascendis US, added that favorable policies are being put in place, and many patients are getting approved even without formal policies, indicating strong clinical value recognition.

Q: Can you provide a breakdown of YORVIPATH revenue between the US and ex-US markets for the quarter? A: Jan Moller Mikkelsen, CEO, explained that while they don't disclose exact numbers, the US market saw significant growth, contributing to the increase from EUR14 million to EUR45 million. The ex-US market showed steady growth, with an expected acceleration in the second half of the year as more countries achieve full reimbursement.

Q: Have you completed negotiations with most commercial payers, and do you expect future policies to be similar to existing ones? A: Jay Wu, President of Ascendis US, stated that negotiations are progressing well, with multiple favorable commercial policies in place. The gross-to-net arrangements are consistent with the clinical value proposition of YORVIPATH, reflecting its status as the first and only approved product in a rare-disease setting.

Q: What proportion of new YORVIPATH prescriptions are from patients who are naive to Natpara or PTH versus those with prior experience? A: Sherrie Glass, Chief Business Officer, noted that the majority of patients are transitioning from conventional therapy, with about 10% to 15% having prior PTH experience. A subset of these were previously on Natpara, but overall, most patients are coming from conventional therapy.

Q: How are you managing the potential bottleneck of physician offices handling reimbursement processes for YORVIPATH? A: Jay Wu, President of Ascendis US, emphasized that their hub is well-equipped to handle volume and speed, supported by a strong field reimbursement manager team. They are ensuring that office burden does not become a bottleneck, leveraging experience from managing growth hormone deficiency cases.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.