Ascendis Pharma Reports Second Quarter 2024 Financial Results

Core Insights - Ascendis Pharma has received FDA approval for YORVIPATH, the first and only treatment for hypoparathyroidism in adults, highlighting the company's commitment to addressing unmet medical needs [2][4] - The company reported a second quarter revenue of €36 million, a decrease from €47.4 million in the same period last year, primarily due to negative adjustments in sales deductions [9][10] - SKYTROFA revenue for Q2 2024 was €26 million, reflecting a 27% year-over-year decrease, although there was a 134% increase in volume [3][9] - The company anticipates full-year 2024 SKYTROFA revenue to be between €220 million and €240 million [8] Financial Performance - Total revenue for Q2 2024 was €36 million, down from €47.4 million in Q2 2023, impacted by a negative adjustment of €27.1 million in sales deductions [9][10] - YORVIPATH generated €5.2 million in revenue during its first full quarter of commercial launch in Germany and Austria [4] - Research and development costs for Q2 2024 were €83.5 million, a decrease from €105 million in Q2 2023, attributed to lower external development costs [11][12] - The 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 [12][19] Product Development and Pipeline - The company is preparing for the U.S. launch of YORVIPATH and expects initial supply to be available in Q1 2025, with potential earlier introduction in Q4 2024 [4][8] - Topline results from the pivotal ApproaCH Trial for TransCon CNP are expected in the coming weeks, with plans to submit a New Drug Application to the FDA for children with achondroplasia in Q1 2025 [5][6] - Ascendis Pharma is on track to submit a supplemental Biologics License Application for adult growth hormone deficiency for SKYTROFA in Q3 2024 [3][8] Market Position and Strategy - Ascendis Pharma's focus on rare endocrine diseases is underscored by the approval of two out of three of its TransCon product candidates, positioning the company for potential blockbuster status in the U.S. market [2][4] - The company has entered into a $150 million capped synthetic royalty funding agreement with Royalty Pharma related to YORVIPATH sales in the U.S. [8]