Ascendis Pharma A/S Q4 FY2025 earnings call

Ascendis transforming into leading global biopharma. Strong execution in 2025. Yorvipath global launch strong, Skytrofa and TransCon CNP showing progress. Advancing development of Yorvipath label expansion, Skytrofa Phase III trial, TransCon CNP combination therapy. Partnerships advancing, like collaboration with Novo Nordisk for once-monthly TransCon semaglutide.

Yorvipath: Q4 2025 revenue was €187,000,000, full-year 2025 revenue was €477,000,000. In US, over 5,300 patients prescribed by nearly 2,400 providers, less than 5% of US patients on treatment, insurance approval rate ~70%, majority approvals within 8 weeks. Outside US, available in over 30 countries, full commercial reimbursement in 4 Europe direct and 2 international markets, expect 10 new country launches in 2026. Skytrofa: Q4 2025 revenue €53,000,000, full-year €206,000,000. Market share ~7% in US. Initiated Phase III basket trial for additional growth hormone indications. TransCon CNP: Pivotal trial showed significant improvement vs placebo, NDA for children with achondroplasia in US under review, MAA in EU underway, Phase II combination trial data shows dual therapy potential with TransCon Growth Hormone.

Expect continued strong revenue growth for Yorvipath in 2026 based on steady patient uptake with seasonality. Skytrofa expected to follow seasonal pattern with revenue growth tracking prescriptions. Aim to achieve operating cash flow of around €500,000,000 in 2026 and at least €5,000,000,000 in annual product revenue by 2030. TransCon CNP approval in US later this month excluded from 2026 outlook.

Actual results may differ from forward-looking statements due to factors like regulatory decisions, clinical trial outcomes, exchange rate impacts, competition, etc. As investigational products, safety and effectiveness not reviewed/approved. Potential issues with competitive agents and regulatory uncertainties.

Q: What is your confidence level heading into the TransCon CNP PDUFA?

A: Jan Moller Mikkelsen says confident, believes issue leading to review extension resolved to FDA's satisfaction.

Q: When might Yorvipath get to 100% insurance approval in US?

A: Likely infinity, but 70% now, some states have staggered reviews, ex-US system different with nearly 100% approval on prescription.

Q: How will TransCon CNP launch factor into 2026 operating cash flow?

A: Not incorporated yet, initial uptake expected high in US and ex-US, will provide better guidance after seeing launch.

Q: Thoughts on competitive landscape for TransCon CNP?

A: Jan Moller Mikkelsen discusses differences with other agents, importance of PK profile and unique benefits of TransCon CNP