Ascendis Pharma Announces Q2 2024 Financial Results

Ascendis Pharma A/S (Nasdaq: ASND), based in Copenhagen, Denmark, has reported its financial results for the second quarter ending June 30, 2024, and provided significant business updates. Highlighting the quarter was the U.S. FDA approval of YORVIPATH, a new treatment for hypoparathyroidism in adults, marking a major milestone for the company.

Jan Mikkelsen, President and CEO of Ascendis Pharma, emphasized the importance of the FDA approval for YORVIPATH, asserting that it underscores the company's dedication to addressing unmet medical needs in serious diseases. The company's first product, SKYTROFA, has already achieved market leadership in the U.S. With YORVIPATH, Ascendis is well-prepared for its second U.S. product launch. Additionally, the company is anticipating pivotal trial results for TransCon CNP (navepegritide) in children with achondroplasia.

Financial Performance

The second quarter of 2024 saw Ascendis Pharma generate total revenue of €36.0 million, down from €47.4 million in the same period in 2023. This decline was mainly due to a negative adjustment of €27.1 million for prior periods' sales deductions. However, increased demand for SKYTROFA and the introduction of YORVIPATH contributed positively to the revenue. Non-product revenue also decreased from €11.5 million to €4.6 million year-over-year.

Revenue from SKYTROFA in Q2 2024 was €26.2 million, a significant drop from the €35.9 million in Q2 2023 due to adjustments related to broader market access costs. However, for the first half of 2024, SKYTROFA revenue increased by 35% to €91.2 million compared to €67.4 million in the first half of 2023. Ascendis plans to submit a supplemental Biologics License Application for SKYTROFA for adult growth hormone deficiency in Q3 2024 and expects topline results from Phase 2 of the New InsiGHTS Trial in Turner syndrome by Q4 2024.

Product Developments

TransCon PTH (YORVIPATH):
- Recently approved by the U.S. FDA for treating adult hypoparathyroidism.
- Initial supply for the U.S. market is expected in Q1 2025, with possible earlier commercialization in Q4 2024.
- Q2 2024 revenue for YORVIPATH was €5.2 million, reflecting the first full quarter of its commercial launch in Germany, Austria, and initial revenue from other international markets. Revenue from France is anticipated to begin in Q4 2024.

TransCon CNP:
- Topline data from the pivotal ApproaCH Trial is expected soon, with plans to submit a New Drug Application to the FDA for children with achondroplasia in Q1 2025.
- Recruitment completion for the COACH trial and initial results from the teACH Phase 2 trial in adolescents with achondroplasia are expected in the third and fourth quarters of 2024, respectively.

Oncology Programs:
- New and updated results from the Phase 1/2 IL-Believe Trial involving TransCon IL-2 β⁄γ were presented at the ASCO 2024 conference, showing promising clinical responses in patients with anti-PD-1 refractory melanoma.
- Results from the Phase 2 dose expansion cohort of the IL-Believe Trial in patients with platinum-resistant ovarian cancer (PROC) will be presented at the ESMO 2024 Congress.

Financial Position

As of June 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €259 million, a decrease from €399 million as of December 31, 2023. The company's net loss for Q2 2024 was €109.4 million, or €1.91 per share, compared to a net loss of €121.4 million, or €2.16 per share, in Q2 2023.

Outlook

Ascendis expects full-year 2024 SKYTROFA revenue to be between €220 million and €240 million. Total operating expenses for 2024 are projected to be around €600 million. The timing of YORVIPATH's U.S. launch will be a key factor in achieving cash flow breakeven on a quarterly basis in 2024 or 2025.

In summary, Ascendis Pharma continues to advance its pipeline products, with significant progress in regulatory approvals and clinical trials, while managing financial challenges and preparing for future growth in the biopharma market.

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