Ascendis Pharma (ASND) Q2 2024 earnings summary

Executive summary

• Achieved US FDA approval for Yorvipath, the first and only treatment for adult hypoparathyroidism, with commercial launch preparations underway and initial US supply expected in early 2025; continued strong launches in Europe, with over 250 patients on therapy and 98% retention rate in Germany and Austria.

• Skytrofa volume more than doubled year-over-year (134% growth in Q2), but reported Q2 revenue declined 27% due to higher sales deductions and a €27 million negative adjustment related to broader market access reset.

• Pivotal ApproaCH trial topline results for TransCon CNP in achondroplasia expected soon, with potential US NDA submission in Q1 2025 and the goal of approval for all three endocrinology rare disease candidates by end of 2025.

Financial highlights

• Q2 2024 total revenue was €36 million, including €26.2 million from Skytrofa (down 27% year-over-year) and €5.2 million from Yorvipath.

• Skytrofa H1 2024 revenue reached €91.2 million, up 35% year-over-year, with volume more than doubling.

• Q2 revenue was reduced by a €27.1 million true-up, mainly related to prior period sales deductions.

• R&D expenses fell 21% to €83.5 million, and total operating expenses dropped 10% to €157.8 million in Q2.

• Net finance income was €29.4 million, and cash, cash equivalents, and marketable securities totaled €259 million at quarter-end, down from €399 million at year-end 2023.

Outlook and guidance

• Full-year 2024 Skytrofa revenue expected between €220 million and €240 million.

• Total 2024 operating expenses projected at approximately €600 million, including Yorvipath US launch activities.

• Operating cash flow breakeven anticipated on a quarterly basis in 2024 or 2025, depending on Yorvipath US launch timing.