Ascendis Pharma A/S (NASDAQ:ASND) reported third-quarter product revenue of EUR 366 million, up 89% from a year earlier, as sales of hypoparathyroidism treatment YORVIPATH and recently launched achondroplasia drug YUVIWEL grew.
The company also raised its expectation for 2026 operating cash flow to at least EUR 600 million. Chief Financial Officer Scott Smith said operating cash flow was EUR 189 million in the third quarter, while reported operating profit reached EUR 125 million.
Chief Executive Officer Jan Mikkelsen said Ascendis expects growth from its three marketed products, potential label expansions and new medicines developed with its TransCon technology. The company reiterated its goal of more than EUR 5 billion in annual product revenue in 2030; Smith also cited a EUR 10 billion revenue goal for 2035.
YORVIPATH Leads Sales Growth
YORVIPATH generated EUR 291 million in third-quarter revenue, up 103% from a year earlier and EUR 39 million above the second quarter. Mikkelsen said U.S. demand from new patients remained consistent with prior quarters, including during the summer months.
During the question-and-answer session, Mikkelsen said the company continues to expect more than 1,000 new U.S. patients per quarter. Jay Wu, president of the U.S. market, said Ascendis added about 300 new YORVIPATH prescribers in the third quarter and was seeing existing prescribers treat more patients.
Ascendis estimates that 70,000 to 90,000 adults in the United States have chronic hypoparathyroidism. It launched a U.S. disease-awareness campaign in September and expects its impact to build gradually, with additional campaigns planned for 2027.
Outside the United States, YORVIPATH was fully commercially available in 13 countries, with another 15 markets expected in 2027, Mikkelsen said. He described international growth as more gradual than in the United States because the company must establish reimbursement country by country.
YUVIWEL Launch and European Decision
YUVIWEL, a once-weekly treatment for children with achondroplasia, generated EUR 16 million in third-quarter revenue, double the EUR 8 million recorded in its first quarter on the U.S. market. Mikkelsen said approximately 340 patients had enrolled through October, with more than 80% already approved for reimbursement.
The company said it was seeing patients switch from daily therapy, return to treatment or start treatment for the first time. Ascendis estimates that around 70% of U.S. children with achondroplasia remain untreated.
In Europe, YUVIWEL received a positive opinion from the Committee for Medicinal Products for Human Use in October. Ascendis expects a European Commission decision before year-end and, if approved, plans to launch first in Germany in the first quarter of 2027.
SKYTROFA, the company’s growth hormone treatment, generated EUR 59 million in third-quarter revenue, up EUR 4 million from the prior quarter.
Clinical Programs and Pipeline
Ascendis is pursuing more than 20 ongoing or planned studies to expand the indications for its marketed products. For YUVIWEL’s active therapy, TransCon CNP, a fully enrolled infant trial is expected to produce top-line results in 2027. The company also plans to start a Phase 2 study in adults with achondroplasia before year-end and a Phase 3 study in children with hypochondroplasia during the fourth quarter.
Recruitment has begun for a Phase 3 trial combining TransCon CNP with TransCon growth hormone in children with achondroplasia. Mikkelsen said the trial was enlarged and delayed by a few months after regulatory feedback led the company to add a growth hormone-only arm, alongside CNP-only and combination arms.
Ascendis also expects to complete enrollment in the first half of 2027 for a SKYTROFA basket trial covering several growth disorders. Mikkelsen said the company plans to disclose a new therapeutic focus area in the coming year and provide a broader early-stage pipeline update in early 2027.
Cash Flow and Share Repurchases
Third-quarter operating expenses fell to EUR 217 million from EUR 249 million in the second quarter, primarily because of lower litigation costs and the timing of commercial initiatives, Smith said. Non-IFRS operating profit was EUR 156 million, representing a 42% margin.
Ascendis ended September with EUR 964 million in cash. Through Nov. 11, the company had repurchased 2 million shares for approximately $460 million year to date. Smith said about $330 million of a current $400 million buyback program had been used.
For the fourth quarter, Smith said Ascendis expects YORVIPATH growth consistent with prior quarters, relatively stable U.S. SKYTROFA revenue and continued U.S. demand growth and reimbursement approval trends for YUVIWEL.
About Ascendis Pharma A/S (NASDAQ:ASND)
Ascendis Pharma A/S is a biopharmaceutical company headquartered in Denmark that develops medicines for rare diseases, with a focus on endocrinology. Founded in 2006, the company uses its TransCon technology platform to design therapies intended to provide sustained delivery of medicines. Its commercial products include SKYTROFA (lonapegsomatropin), a once-weekly growth hormone treatment for children with growth hormone deficiency, and YORVIPATH (palopegteriparatide), a treatment for adults with hypoparathyroidism.
