Ascendis Pharma Showcases 2025 Strategy And Financial Highlights At J.P. Morgan Conference
Ascendis Pharma reveals 2025 plans, pipeline updates, and financial growth at J.P. Morgan Conference.
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Jan 13, 2025
Simantini Singh Deo
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Ascendis Pharma Showcases 2025 Strategy And Financial Highlights At J.P. Morgan Conference
Ascendis Pharma A/S has shared an update on its business and strategic plans, including key corporate milestones for 2025. The company's President and CEO, Jan Mikkelsen, will present these updates on January 13 at the 43rd Annual J.P. Morgan Healthcare Conference.
Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer, said in a statement, “Ascendis is well-positioned for rapid revenue growth with the launch of our first two Endocrinology Rare Disease medicines, SKYTROFA and YORVIPATH, and, following our pre-NDA meeting, planned filings for our third, TransCon CNP for achondroplasia. Our expanding TransCon technology platform and partnerships demonstrate that our business model built on fast, successful drug development can create substantial stakeholder value.”
Some of the Key Updates are as follows:
Updates On Therapy Pipeline
SKYTROFA® (lonapegsomatropin) volume increased by 84% in 2024; this results in an estimated 6.5% market share of the total U.S. growth hormone market for 2024. The Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025, is for the FDA to review supplemental BLA for treating adults with growth hormone deficiency. The commercial launch is planned for the fourth quarter of 2025. SKYTROFA's full-year 2024 revenue, with a single indication in pediatric GHD, is expected to be ~€202 million
YORVIPATH® (palopegteriparatide) ~€29 million is the estimated preliminary revenue for 2024. The drug is commercially available for prescription in Germany and Austria. Three hundred twenty-four patients enrolled in the Ascendis Signature Access Program or were directly with speciality pharmacies, with over half of the prescriptions for patients new to YORVIPATH.
Ascendis Pharma plans to submit a New Drug Application (NDA) for treating children with achondroplasia during the first quarter of 2025. Topline Week 26 results from Phase 2 COACH Trial (TransCon CNP in combination with TransCon hGH) are expected in the second quarter of 2025.
Updates On Expanding Pipeline
One significant development is the expansion of Ascendis’ TransCon platform and pipeline. The company introduced a new protein degrader platform designed to efficiently clear hormones, cytokines, and other targets. This platform's first planned product candidate aims to address excess FGF-23 hormone levels in patients with X-linked hypophosphatemia.
Financial Performance
Additionally, Ascendis expects its total revenue for 2024 to be about €364 million, of which €100 million is non-product revenue in the form of a milestone payment from Novo Nordisk. When this study was prepared for 31 December 2024, the estimates of cash make up the Novo Nordisk payment of approximately €655 million.
Ascendis reported an unaudited preliminary estimate of approximately €226 million in total product revenue in 2024. This includes an expected €202 million from SKYTROFA, excluding sales deductions from previous years. The company also estimates €29 million in revenue from YORVIPATH.
About Presentation
The presentation will be available via a live webcast on Ascendis Pharma’s website, beginning at 11:15 a.m. Eastern Time / 8:15 a.m. Pacific Time. A replay will be accessible for 30 days after the event.