On August 7, 2025 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Ascendis Pharma, AUG 7, 2025, View Source [SID1234654962]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With the robust global uptake of YORVIPATH and with TransCon CNP under U.S. FDA priority review, Ascendis is on the verge of bringing our third high-value medicine to patients and substantially transforming our financial profile," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "We expect our engine for future innovation to drive continued momentum as we aim to address unmet medical need in endocrine rare diseases and other large indications for years to come on our path to fulfilling Vision 2030."

Select Highlights & Anticipated 2025 Milestones

TransCon PTH:
(palopegteriparatide, marketed as YORVIPATH)
YORVIPATH revenue for the second quarter of 2025 totaled €103.0 million, including a negative foreign currency impact of €5.8 million compared to the previous quarter.
Continued uptake from YORVIPATH in the U.S., with around 3,100 unique patient enrollments and more than 1,500 prescribing health care providers as of June 30, 2025.
Outside the U.S., YORVIPATH generated revenue from more than 30 countries.
Initiated PaTHway60, a single-arm safety and efficacy trial in patients to support U.S. label expansion to enable titration up to 60 µg dose.
Recent presentations at medical conferences in Europe and the U.S. of TransCon PTH data out to four years of treatment demonstrate that preserving the same mode of action and providing active PTH within the physiological range for 24 hours per day comparable to endogenous PTH can normalize key elements such as calcium, phosphate, kidney function, bone turnover, and quality of life.
TransCon hGH:
(lonapegsomatropin, marketed as SKYTROFA)
SKYTROFA revenue for the second quarter of 2025 totaled €50.7 million, including a negative foreign currency impact of €1.8 million compared to the previous quarter.
SKYTROFA approved by FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).
During the fourth quarter of 2025, plan to initiate basket trial for several established growth-hormone indications including: Idiopathic Short Stature (ISS), short stature homeobox-containing gene deficiency (SHOX deficiency), Turner syndrome, and Small for Gestational Age (SGA).
TransCon CNP:
(navepegritide, NDA filed)
FDA accepted for priority review the New Drug Application (NDA) for the treatment of children with achondroplasia, Prescription Drug User Fee Act (PDUFA) goal date of November 30, 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 and in combination with TransCon hGH for the treatment of hypochondroplasia.
TransCon CNP + TransCon hGH Combination Therapy
(navepegritide plus lonapegsomatropin)
Reported interim topline Week 26 data from COACH, the combination TransCon CNP and TransCon hGH trial. Week 26 data showed improved treatment benefits in children with achondroplasia (ages 2-11 years). Week 52 data expected in the fourth quarter of 2025.
Initiation of a Phase 3 combination trial expected in the fourth quarter of 2025.
Oncology Programs
Clinical development of TransCon IL-2 β/γ continues.
Financial Update
As of June 30, 2025, Ascendis Pharma had cash and cash equivalents totaling €494 million, compared to €560 million as of December 31, 2024.
Second Quarter 2025 Financial Results
Total revenue for the second quarter of 2025 was €158.0 million, compared to €36.0 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 €97.8 million from YORVIPATH.

Total Revenue
(In EUR’000s) Three Months Ended June 30, Six Months Ended June 30,
2025 2024 2025 2024
Revenue
Commercial products 153,663 31,389 249,690 97,888
Rendering of services and clinical supply 3,570 3,740 7,094 8,365
Licenses 812 869 2,214 25,639
Total revenue 158,045 35,998 258,998 131,892

Commercial Product Revenue
(In EUR’000s) Three Months Ended June 30, Six Months Ended June 30,
2025
2024 2025 2024
Revenue from commercial products
SKYTROFA 50,706 26,202 102,044 91,207
YORVIPATH 102,957 5,187 147,646 6,681
Total revenue from commercial products 153,663 31,389 249,690 97,888

Research and development costs for the second quarter of 2025 were €72.0 million, compared to €83.5 million during the same period in 2024. The decrease was driven by the maturity of clinical trials within our growth disorders portfolio.

Selling, general, and administrative expenses for the second quarter of 2025 were €107.6 million, compared to €74.3 million during the same period in 2024. The increase was primarily due to the continued impact from commercial expansion, including global launch activities for YORVIPATH.

Total operating expenses for the second quarter of 2025 were €179.5 million, compared to €157.8 million during the same period in 2024.

Net finance income for the second quarter of 2025 was €22.0 million, compared to €29.4 million during the same period in 2024. The decrease was primarily driven by non-cash items.

For the second quarter of 2025, Ascendis Pharma reported a net loss of €38.9 million, or €0.64 per share basic and €0.82 diluted compared to a net loss of €109.4 million, or €1.91 per share basic and €2.21 diluted for the same period in 2024.

As of June 30, 2025, Ascendis Pharma had cash and cash equivalents totaling €494 million compared to €560 million as of December 31, 2024. As of June 30, 2025, Ascendis Pharma had 61,151,463 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 second 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.