Ascendis Pharma A/S Q1 FY2025 earnings call

• YORVIPATH's US launch was an inflection point, with over 1,000 prescribers and 1,750 patients in the first full quarter. It's the first FDA-approved treatment for adult hypoparathyroidism.
• SKYTROFA is a key pillar, with steady revenue and potential for label expansion, including a BLA submission for adult growth hormone deficiency with a PDUFA goal date of July 27, 2025.
• TransCon CNP showed significant linear growth improvement in the ApproaCH Trial, with NDA submitted to FDA in March and MAA planned for EU Q3 2025. The COACH Trial is ongoing to evaluate the combination with TransCon Growth Hormone.
• Utilizes Ascendis' proprietary TransCon technology platform, which is fundamental to the development of its product portfolio.

YORVIPATH: First quarter revenue increased to €44.7 million, up from €13.6 million in Q4 2024. As of March 31, over 1,000 unique prescribers in the US had prescribed YORVIPATH for over 1,750 patients. SKYTROFA: Q1 revenue was €51.3 million. It holds 7% market share of the US growth hormone market and 43% of the US long acting growth hormone market. TransCon CNP: NDA submitted to FDA in March for treatment of achondroplasia, with an MAA planned for the EU in Q3 2025. Revenue contribution details: YORVIPATH's Q1 revenue was €44.7M, SKYTROFA's was €51.3M, and total first quarter revenue was €101M including non-product revenue.

• Substantial revenue growth is expected driven by YORVIPATH's global launch and SKYTROFA's contribution.
• No specific revenue guidance for SKYTROFA or YORVIPATH at present.
• SKYTROFA's prescription growth is expected to track sequential revenue growth with normal seasonality.
• YORVIPATH is seeing steady revenue growth outside the US and strong progress in the US launch.

• Uncertainty in reimbursement rates for YORVIPATH.
• Challenges in commercial expansion and payer negotiations.
• Dependence on regulatory approvals for product candidates like TransCon CNP.

Q: Jessica Fye asked about YORVIPATH's reimbursement expectations and channel inventory.

A: Jan Mikkelsen and Scott Smith responded, with Jan discussing reimbursement guesses and Scott talking about channel inventory averaging 1-2 weeks.

Q: Tazeen Ahmad inquired about the US vs ex-US revenue split for YORVIPATH and the time from script to therapy.

A: Jan Mikkelsen provided insights on ex-US revenue growth and expected acceleration.

Q: Gavin Clark Gartner asked about payer negotiations and new prescriptions.

A: Jan Mikkelsen, Jay Wu, and Sherrie Glass responded on payer negotiations and the majority of patients coming from conventional therapy.

Q: Joseph Schwartz asked about clinical benefit from TransCon CNP and hGH combination and follow-up on YORVIPATH.

A: Jan Mikkelsen discussed expectations from the COACH Trial and Jay Wu addressed YORVIPATH resource support.

Q: Li Watsek asked about YORVIPATH contracting and Phase 2 COACH trial.

A: Scott Smith and Aimee Shu responded on gross to net and trial titration.

Q: Ellie Merle asked about YORVIPATH patient feedback.

A: Jan Mikkelsen discussed high adherence and low dropout rates.

Q: Luca Issi asked about competition and SG&A.

A: Jan Mikkelsen and Sherrie Glass responded on competition and SG&A trends.

Q: David Lebowitz asked about NATPARA patients and YORVIPATH benefit.

A: Jan Mikkelsen responded on NATPARA patient transition and clinical benefit difference.

Q: Leland Gershell asked about YORVIPATH reimbursement for renal impairment and COACH data.

A: Jan Mikkelsen and Aimee Shu responded on reimbursement and COACH trial expectations.