Ascendis Pharma A/S (Nasdaq: ASND) has released its financial results for the second quarter, which ended on June 30, 2024, alongside a business update.
“The recent FDA approval of YORVIPATH underscores our commitment to helping patients with hypoparathyroidism and other serious diseases with significant unmet needs,” said Jan Mikkelsen, President and CEO of Ascendis Pharma. “We’ve seen success with two of our three Endocrine Rare Disease TransCon products gaining approval from the FDA and European Commission. SKYTROFA, our first approved product, has achieved U.S. market leadership, and with expanded market access, we believe it is positioned to reach blockbuster status. Looking ahead, we’re preparing for our second U.S. launch with YORVIPATH and anticipate releasing pivotal data soon for our third TransCon product, TransCon CNP.”
Key Highlights & 2024 Milestones:
TransCon hGH (SKYTROFA)
- Q2 2024 revenue was €26.2 million, a 27% decrease from €35.9 million in Q2 2023, despite a 134% increase in volume. The decline was due to market access costs and adjustments to previous sales deductions.
- H1 2024 revenue reached €91.2 million, a 35% increase compared to €67.4 million in H1 2023.
- A supplemental Biologics License Application for adult growth hormone deficiency will be submitted to the FDA in Q3 2024.
- Phase 2 trial results for Turner syndrome expected in Q4 2024.
TransCon PTH (YORVIPATH)
- FDA approved YORVIPATH for treating adult hypoparathyroidism.
- Manufacturing is underway, with initial U.S. supply expected in Q1 2025. Discussions with the FDA could lead to early U.S. availability in Q4 2024.
- Q2 revenue for YORVIPATH was €5.2 million, driven by launches in Germany and Austria. Initial revenue from France is expected in Q4 2024.
TransCon CNP (navepegritide)
- Topline data from the pivotal ApproaCH trial for children with achondroplasia are expected soon, with plans to submit an NDA in Q1 2025.
- Enrollment in the combination trial of TransCon hGH and TransCon CNP is expected to be completed by Q3 2024, with data available in Q2 2025.
- A Phase 2 trial in adolescents with achondroplasia will begin in Q4 2024.
Oncology Programs
- Positive interim results from the Phase 1/2 IL-Believe trial for TransCon IL-2 β⁄γ were presented at ASCO 2024.
- Initial results from a Phase 2 trial in platinum-resistant ovarian cancer will be presented at ESMO 2024 in Barcelona, Spain.
Financial Summary for Q2 2024:
- Total Revenue: €36.0 million, down from €47.4 million in Q2 2023, impacted by a €27.1 million adjustment to prior sales estimates. Increased demand for SKYTROFA and YORVIPATH partially offset this decline.
- R&D Expenses: €83.5 million, down from €105.0 million in Q2 2023, reflecting lower external development costs and employee-related expenses after the Eyconis spin-off.
- SG&A Expenses: €74.3 million, up from €70.3 million in Q2 2023, due to higher employee costs and commercial expansion.
- Operating Expenses: €157.8 million, down from €175.3 million in Q2 2023.
- Net Finance Income: €29.4 million, up from €26.4 million in Q2 2023.
- Net Loss: €109.4 million (€1.91 per share), compared to €121.4 million (€2.16 per share) in Q2 2023.
As of June 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €258.7 million, down from €399.4 million as of December 31, 2023. The company also has 58,231,484 outstanding ordinary shares.
