• Ascendis Pharma Reports Second Quarter 2025 Financial Results

    Источник: Nasdaq GlobeNewswire / 07 авг 2025 13:01:00   America/Los_Angeles

    – Q2 2025 revenue of €103.0 million for YORVIPATH® and €50.7 million for SKYTROFA®

    – TransCon® CNP (navepegritide) NDA under Priority Review for the treatment of children with achondroplasia with PDUFA date of November 30, 2025

    – SKYTROFA® (lonapegsomatropin-tcgd) approved in the U.S. for treatment of adults with growth hormone deficiency; first of many planned label expansions 

    – Week 26 Interim Results for COACH trial highlight the unique portfolio of once-weekly TransCon CNP and once-weekly TransCon hGH, with complementary modes of action, to potentially further transform the treatment landscape for growth disorders and physical functioning

    –Conference call today at 4:30 pm ET

    COPENHAGEN, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the second quarter ended June 30, 2025, and provided a business update.

    “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 products153,663 31,389 249,690 97,888
    Rendering of services and clinical supply3,570 3,740 7,094 8,365
    Licenses812 869 2,214 25,639
    Total revenue158,045 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 products153,663 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 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
    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ planned MAA submission for TransCon CNP; (ii) the timing and results of clinical trials; (iii) Ascendis’ expectations with respect to its revenue base and path to cashflow breakeven; (iv) the potential approval of TransCon CNP as a monotherapy in children with achondroplasia; (v) Ascendis’ ability to provide patients with highly differentiated medicines; (vi) the planned label expansions of SKYTROFA; (vii) Ascendis’ expectations regarding the PDUFA date for TransCon CNP; (viii) Ascendis’ plans to submit IND applications or similar for a basket trial evaluating TransCon hGH in additional indications and to investigate TransCon CNP alone or in combination with TransCon hGH for the treatment of hypochondroplasia; (ix) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients, and (x) Ascendis’ application of its TransCon technologies to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors, including tariffs and trade policies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

    Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA®, and YORVIPATH® are trademarks owned by the Ascendis Pharma group.
    © August 2025 Ascendis Pharma A/S.

      
    Investor Contacts:Media Contact:
    Sarada WeerasingheMelinda Baker
    Ascendis PharmaAscendis Pharma
    ir@ascendispharma.commedia@ascendispharma.com
      
    Patti Bank 
    ICR Healthcare 
    +1 (415) 513-1284 
    patti.bank@icrhealthcare.com 
      


    FINANCIAL TABLES FOLLOW

     
    Ascendis Pharma A/S
    Consolidated Statements of Profit or (Loss) and Comprehensive Income / (Loss)
    (In EUR'000s, except per share data)    		Three Months Ended
    June 30,    		 Six Months Ended
    June 30,
     2025
    		 2024
    		 2025
    		 2024
    Consolidated Statement of Profit or (Loss)       
    Revenue158,045  35,998  258,998  131,892 
    Cost of sales31,447  11,465  48,963  19,034 
    Gross profit126,598  24,533  210,035  112,858 
    Research and development expenses71,988  83,478  158,591  154,165 
    Selling, general, and administrative expenses107,561  74,312  208,608  141,095 
    Operating profit/(loss)(52,951) (133,257) (157,164) (182,402)
    Share of profit/(loss) of associates(4,097) (5,322) 22,482  (11,118)
    Finance income55,059  49,052  83,912  14,395 
    Finance expenses33,018  19,624  77,803  58,553 
    Profit/(loss) before tax(35,007) (109,151) (128,573) (237,678)
    Income taxes (expenses)(3,848) (229) (4,909) (2,737)
    Net profit/(loss) for the period(38,855) (109,380) (133,482) (240,415)
    Attributable to owners of the Company(38,855) (109,380) (133,482) (240,415)
    Basic earnings/(loss) per share€ (0.64) € (1.91) € (2.22) € (4.21)
    Diluted earnings/(loss) per share€ (0.82) € (2.21) (1) € (2.22) € (4.21)
    (1)Dilutive earnings per share for the three months ended June 30, 2024, has been restated. Refer to Note 6, “Earnings Per Share” for further information.  
        
    Consolidated Statement of Comprehensive Income or (Loss)       
    Net profit/(loss) for the period(38,855) (109,380) (133,482) (240,415)
    Other comprehensive income/(loss)       
    Items that may be reclassified subsequently to profit or (loss):       
    Exchange differences on translating foreign operations(1,399) 15  (1,474) 78 
    Other comprehensive income/(loss) for the period, net of tax(1,399) 15  (1,474) 78 
    Total comprehensive income/(loss) for the period, net of tax(40,254) (109,365) (134,956) (240,337)
    Attributable to owners of the Company(40,254) (109,365) (134,956) (240,337)
            



     
    Ascendis Pharma A/S
    Consolidated Statements of Financial Position
    (In EUR'000s)    		June 30, 2025 December 31, 2024
    Assets   
    Non-current assets   
    Intangible assets3,790  4,028 
    Property, plant and equipment93,542  98,714 
    Investments in associates34,902  13,575 
    Other receivables2,711  2,317 
     134,945  118,634 
    Current assets   
    Inventories303,381  295,609 
    Trade receivables110,452  166,280 
    Income tax receivables2,738  1,775 
    Other receivables8,029  9,385 
    Prepayments34,311  28,269 
    Cash and cash equivalents494,046  559,543 
     952,957  1,060,861 
    Total assets1,087,902  1,179,495 
        
    Equity and liabilities   
    Equity   
    Share capital8,211  8,149 
    Distributable equity(195,783) (113,855)
    Total equity(187,572) (105,706)
        
    Non-current liabilities   
    Borrowings330,186  365,080 
    Contract liabilities692  5,000 
    Deferred tax liabilities9,596  7,258 
     340,474  377,338 
    Current liabilities   
    Convertible notes, matures in April 2028   
    Borrowings418,073  458,207 
    Derivative liabilities186,579  150,670 
     604,652  608,877 
    Other current liabilities   
    Borrowings44,275  33,329 
    Contract liabilities1,789  936 
    Trade payables and accrued expenses93,718  96,394 
    Other liabilities39,924  67,956 
    Income tax payables711  1,222 
    Provisions149,931  99,149 
     330,348  298,986 
     935,000  907,863 
    Total liabilities1,275,474  1,285,201 
    Total equity and liabilities1,087,902  1,179,495 
        

    Primary Logo

Опубликовать