On May 1, 2025 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Ascendis Pharma, MAY 1, 2025, View Source [SID1234652424]).
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"The strong global launch of YORVIPATH positions 2025 to be an inflection point for Ascendis with growing revenue and a path to cashflow breakeven in the near term," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "We look forward to potential approvals of our third product, TransCon CNP, as a monotherapy in children with achondroplasia, and we believe the upcoming topline COACH combination trial data may demonstrate improved outcomes, including growth, compared to TransCon CNP alone. With our diversified pipeline, robust supply chain, and strong global commercial capabilities we are well-positioned to deliver on our commitment to provide patients with highly differentiated medicines."
Select Highlights & Anticipated 2025 Milestones
TransCon PTH:
(palopegteriparatide, marketed as YORVIPATH)
YORVIPATH revenue for the first quarter of 2025 totaled €44.7 million.
Continued strong start to U.S. YORVIPATH launch, with more than 1,750 prescriptions as of March 31, 2025, and more than 1,000 unique prescribing health care providers.
On track for commercial launch in at least five additional Europe Direct countries in 2025.
International Markets exclusive distribution agreements covering 75+ countries.
TransCon hGH:
(lonapegsomatropin, marketed as SKYTROFA)
SKYTROFA revenue for the first quarter of 2025 totaled €51.3 million.
Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025, for Food & Drug Administration (FDA) review of supplemental Biologics License Application (BLA) for the treatment of adults with growth hormone deficiency.
During the third quarter of 2025, plan to submit an Investigational New Drug (IND) application or similar for a basket trial evaluating TransCon hGH in additional indications.
TransCon CNP
(navepegritide)
Submitted New Drug Application (NDA) to the FDA for the treatment of children with achondroplasia in the first quarter of 2025; expect to submit Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) during the third quarter of 2025.
During the fourth quarter of 2025, plan to submit an IND or similar to investigate TransCon CNP alone or in combination with TransCon hGH for the treatment of hypochondroplasia.
TransCon CNP + TransCon hGH Combination Therapy
(navepegritide plus lonapegsomatropin, marketed as SKYTROFA)
Topline Week 26 data from COACH, the combination TransCon CNP and TransCon hGH trial of children with achondroplasia (ages 2-11 years) expected in the second quarter of 2025.
Oncology Programs
Clinical development of TransCon IL-2 β/γ continues, including ongoing investigation of clinical activity in platinum-resistant ovarian cancer.
Financial Update
As of March 31, 2025, Ascendis Pharma had cash and cash equivalents totaling €518 million which includes the completion of previously announced share repurchase program and the net settlement of certain Restricted Stock Units for €29 million, compared to €560 million as of December 31, 2024.
On March 21, 2025, VISEN Pharmaceuticals ("VISEN") closed its initial public offering on the Hong Kong Stock Exchange and began trading under the stock code 2561.HK. Ascendis Pharma holds 41,136,364 shares in VISEN. As of March 31, 2025, the total market value of our equity position in VISEN was approximately €260 million.
First Quarter 2025 Financial Results
Total revenue for the first quarter of 2025 was €101.0 million, compared to €95.9 million during the same period in 2024. The year-over-year increase in revenue was primarily attributable to an increase in product revenue which reflected a contribution of €44.7 million from YORVIPATH, following its commercial launch. Non-product revenue decreased to €4.9 million in the first quarter of 2025, compared to €29.4 million for the same period for 2024.
Total Revenue
(In EUR’000s) Three Months Ended
March 31,
2025 2024
Revenue
Commercial products 96,028 66,499
Rendering of services and clinical supply 3,524 4,625
Licenses 1,402 24,770
Total revenue 100,954 95,894
Commercial Product Revenue
(In EUR’000s) Three Months Ended
March 31,
2025 2024
Revenue from commercial products
SKYTROFA 51,340 65,005
YORVIPATH 44,688 1,494
Total revenue from commercial products 96,028 66,499
Research and development costs for the first quarter of 2025 were €86.6 million, compared to €70.7 million during the same period in 2024. The first quarter of 2024 was positively impacted by a reversal of prior period write-downs of pre-launch inventories related to TransCon PTH. The first quarter of 2025 was negatively impacted by an impairment charge related to property, plant and equipment due to change in activities at one of our sites in the U.S.
Selling, general, and administrative expenses for the first quarter of 2025 were €101.0 million, compared to €66.8 million during the same period in 2024. The increase was primarily due to the impact from commercial expansion including global launch activities for YORVIPATH, as well as an impairment charge related to property, plant and equipment due to change in activities at one of our sites in the U.S.
Total operating expenses for the first quarter of 2025 were €187.6 million compared to €137.5 million during the same period in 2024.
Net finance expenses for the first quarter of 2025 was €15.9 million compared to €73.6 million during the same period in 2024. The decrease was primarily driven by non-cash items.
For the first quarter of 2025, Ascendis Pharma reported a net loss of €94.6 million, or €1.58 per share (basic and diluted) compared to a net loss of €131.0 million, or €2.30 per share (basic and diluted) for the same period in 2024.
As of March 31, 2025, Ascendis Pharma had cash and cash equivalents totaling €518 million compared to €560 million as of December 31, 2024. As of March 31, 2025, Ascendis Pharma had 60,970,565 ordinary shares outstanding, including 597,055 ordinary shares represented by ADSs held by the company.
Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its first quarter 2025 financial results.
Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available in this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days.