Ascendis Pharma Reports First Quarter 2025 Financial Results

- Q1 2025 revenue of EUR44.7 million for YORVIPATH$(R)$ and EUR51.3 million for SKYTROFA(R)

- TransCon$(TM)$ CNP NDA submitted in Q1 2025; MAA submission planned in Q3 2025

- Topline COACH combination trial (TransCon CNP + TransCon hGH) data expected in Q2 2025

- Conference call today at 4:30 pm ET

COPENHAGEN, Denmark, May 01, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the first quarter ended March 31, 2025, and provided a business update.

"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 EUR44.7 
             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 EUR51.3 
             million. 
 
          -- Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025, 
             for Food & Drug Administration (FDA) review of supplemental 
             Biologics License Application $(BLA.AU)$ for the treatment of adults 
             with growth hormone deficiency. 
 
          -- During the third quarter of 2025, plan to submit an 
             Investigational New Drug $(IND.AU)$ 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 <BETA>/<GAMMA> 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 EUR518 million which includes the completion 
             of previously announced share repurchase program and the net 
             settlement of certain Restricted Stock Units for EUR29 million, 
             compared to EUR560 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 EUR260 
             million. 

First Quarter 2025 Financial Results

Total revenue for the first quarter of 2025 was EUR101.0 million, compared to EUR95.9 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 EUR44.7 million from YORVIPATH, following its commercial launch. Non-product revenue decreased to EUR4.9 million in the first quarter of 2025, compared to EUR29.4 million for the same period for 2024.

 
Total Revenue                                  Three Months Ended 
 (In EUR'000s)                                      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                 Three Months Ended 
 (In EUR'000s)                                  March 31, 
                                          -------------------- 
                                            2025       2024 
Revenue from commercial products 
SKYTROFA(R)                                  51,340     65,005 
YORVIPATH(R)                                 44,688      1,494 
                                          ---------  --------- 
Total revenue from commercial products       96,028     66,499 
                                          ---------  --------- 
 
 

Research and development costs for the first quarter of 2025 were EUR86.6 million, compared to EUR70.7 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 EUR101.0 million, compared to EUR66.8 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 EUR187.6 million compared to EUR137.5 million during the same period in 2024.

Net finance expenses for the first quarter of 2025 was EUR15.9 million compared to EUR73.6 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 EUR94.6 million, or EUR1.58 per share (basic and diluted) compared to a net loss of EUR131.0 million, or EUR2.30 per share (basic and diluted) for the same period in 2024.

As of March 31, 2025, Ascendis Pharma had cash and cash equivalents totaling EUR518 million compared to EUR560 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 https://investors.ascendispharma.com. 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.

About Ascendis Pharma A/S

Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.

Forward-Looking Statements

(MORE TO FOLLOW) Dow Jones Newswires

May 01, 2025 16:01 ET (20:01 GMT)