SECsense Logo

Ascendis Pharma A/S 6-K Filing: 2025 Milestones & Financial Insights Revealed

$ASND
Form 6-K
Filed on: 2025-01-13
Source
Ascendis Pharma A/S 6-K Filing: 2025 Milestones & Financial Insights Revealed

Key Information and Insights from Ascendis Pharma A/S 6-K Filing:

  1. Company Overview:
  • Name: Ascendis Pharma A/S
  • Location: Tuborg Boulevard 12, DK-2900 Hellerup, Denmark
  • Filing Date: January 13, 2025
  • Commission File Number: 001-36815
  1. Business and Strategic Roadmap Update:
  • A business update was provided by President and CEO Jan Mikkelsen during the J.P. Morgan Healthcare Conference on January 13, 2025.
  1. Key Updates and Milestones for 2025:
  • SKYTROFA (TransCon hGH):
    • Full-year 2024 revenue expected at ~€202 million, with a single indication in pediatric growth hormone deficiency.
    • U.S. market share estimated at 6.5% for 2024, with an 84% increase in volume year-over-year.
    • PDUFA goal date for FDA review of supplemental BLA for adult growth hormone deficiency set for July 27, 2025, with a potential launch in Q4 2025.
  • YORVIPATH (TransCon PTH):
    • Expected full-year 2024 revenue of ~€29 million.
    • Available in Germany and Austria since January 2024, with plans for broader availability in 2025.
  • TransCon CNP:
    • NDA submission planned in Q1 2025 for children with achondroplasia.
    • Marketing authorization application expected in Q3 2025 in Europe.
  • TransCon Protein Degrader Platform:
    • A new platform for developing protein degraders, starting with a candidate targeting FGF-23 for X-linked hypophosphatemia.
  1. Financial Update:
  • Preliminary total revenue estimate for 2024 is ~€364 million, including a $100 million milestone payment from Novo Nordisk.
  • Breakdown of revenue:
    • SKYTROFA: ~€202 million
    • YORVIPATH: ~€29 million
  • Pro forma cash balance as of December 31, 2024, is expected to be ~€655 million.
  1. Forward-Looking Statements:
  • The report contains various forward-looking statements regarding anticipated revenues, regulatory submissions, and product launches. However, actual results may differ due to risks such as reliance on third parties, unforeseen development issues, and market conditions.

This summary encapsulates the critical elements of the 6-K filing, providing insights into the company's performance, strategic initiatives, and future outlook.