Ascendis Pharma A/S (NASDAQ: ASND) stock lost over 1.7% on 28th August, 2020 (as of 9:47 am GMT-4; Source: Google finance) after the company posted lower than expected results for the second quarter of FY 20. For the second quarter, Ascendis Pharma has reported a net loss of €94.9 million compared to a net loss of €58.9 million, for the same period in 2019. At the end of June, 2020, Ascendis Pharma had cash, cash equivalents and marketable securities of total €471.6 million compared to €534.4 million as of March 31, 2020.
Meanwhile, the company is executing across the globe on all elements of their Vision 3×3, that includes preparation for the expected U.S. launch for TransCon hGH following submission of our Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in June, and preparing to submit the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TransCon hGH in Europe planned for third quarter.
ASND in the second quarter of FY 20 has reported the adjusted loss per share of $2.17, missing the analysts’ estimates for the adjusted loss per share of $1.70. The company had reported 55.64% fall in the adjusted revenue to $1,581,000 in the second quarter of FY 20, missing the analysts’ estimates for revenue of $2,530,000. The decline in the revenue was driven by a lower amount of license and service revenue being recognized from the company’s strategic investment in VISEN Pharmaceuticals. Research and development (R&D) costs for the second quarter rose to €63.6 million compared to €43.8 million during the same period in 2019. Higher R&D costs in 2020 was on back of an increase in personnel-related costs, overhead costs allocated to R&D, and the continued progress in development of the company’s product candidates. Selling, general and administrative (SG&A) expenses for the second quarter had increased to €20.8 million compared to €11.0 million during the same period in 2019. The increase is mainly due to additional personnel-related costs, higher IT and other site costs, and continued build out of the company’s commercial capabilities.
Additionally, the company has submitted a BLA for TransCon hGH for pediatric growth hormone deficiency to the FDA on June 25, 2020. In July, the company had received approval of its proposed Paediatric Investigation Plan covering ages 6 months to less than 18 years of age from EMA for TransCon hGH and is on track for a planned third quarter 2020 MAA submission to the EMA for pediatric growth hormone deficiency.