Ascendis Pharma Reports First Quarter 2025 Financial Results
- Revenue growth to €101.0 million in Q1 2025, up from €95.9 million in Q1 2024
- Strong YORVIPATH launch with €44.7 million revenue and 1,750+ prescriptions
- SKYTROFA revenue of €51.3 million showing commercial success
- Reduced net loss to €94.6 million from €131.0 million year-over-year
- Solid cash position of €518 million
- VISEN equity position valued at approximately €260 million
- Operating expenses increased to €187.6 million from €137.5 million year-over-year
- Cash position decreased from €560 million in December 2024 to €518 million
- Impairment charges recorded due to changes in U.S. site activities
Insights
Ascendis shows strong YORVIPATH launch but faces growing expenses and negative equity despite narrowed losses and substantial cash position.
Ascendis Pharma's Q1 2025 results paint a picture of a company at an inflection point, with growing commercial revenue counterbalanced by significant operational expenses. Total revenue reached
This growth has offset the decline in SKYTROFA revenue, which decreased to
The balance sheet shows
As highlighted by CEO Jan Mikkelsen, the company views 2025 as "an inflection point" with "growing revenue and a path to cashflow breakeven in the near term," though specific timeline projections for achieving profitability are not provided in the release.
Ascendis advances rare disease portfolio with promising YORVIPATH launch, TransCon CNP submission, and upcoming combination therapy data.
Ascendis Pharma continues to execute effectively on its TransCon technology platform across multiple rare disease indications. The commercial launch of YORVIPATH (TransCon PTH) for hypoparathyroidism shows promising early adoption with over 1,750 prescriptions and more than 1,000 unique prescribers. The company is expanding globally, with planned launches in five additional European countries and distribution agreements covering more than 75 countries internationally.
Pipeline advancement remains on track, with the submission of the New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia in Q1 2025 and plans to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency in Q3 2025. The upcoming topline data from the COACH combination trial evaluating TransCon CNP with TransCon hGH in children with achondroplasia, expected in Q2 2025, represents a significant catalyst that could potentially demonstrate improved growth outcomes compared to monotherapy.
TransCon hGH (SKYTROFA) continues its commercial presence, with a PDUFA date of July 27, 2025, for the FDA review of the supplemental Biologics License Application for adult growth hormone deficiency, which would expand the addressable patient population. The company also plans to explore additional indications through a basket trial with an IND submission expected in Q3 2025.
The oncology pipeline maintains a lower profile in the update, with ongoing clinical development of TransCon IL-2 β/γ, including investigation in platinum-resistant ovarian cancer, though detailed progress metrics were not provided. The company's integrated approach—spanning research, development, manufacturing, and commercialization—appears to be delivering on its rare disease strategy, with potential for additional value creation as pipeline candidates advance toward potential approval.
Ascendis' focus on rare diseases with its TransCon technology creates a differentiated portfolio addressing significant unmet needs. The progression of TransCon CNP for achondroplasia represents an important potential expansion into a new therapeutic area beyond endocrine disorders, demonstrating the platform's versatility.
- Q1 2025 revenue of
- TransCon™ 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
€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.
- YORVIPATH revenue for the first quarter of 2025 totaled
- 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.
- SKYTROFA revenue for the first quarter of 2025 totaled
- 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 .
- As of March 31, 2025, Ascendis Pharma had cash and cash equivalents totaling
First Quarter 2025 Financial Results
Total revenue for the first quarter of 2025 was
| 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
Selling, general, and administrative expenses for the first quarter of 2025 were
Total operating expenses for the first quarter of 2025 were
Net finance expenses for the first quarter of 2025 was
For the first quarter of 2025, Ascendis Pharma reported a net loss of
As of March 31, 2025, Ascendis Pharma had cash and cash equivalents totaling
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
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) Ascendis’ plans for the commercial launch of TransCon PTH in additional Europe Direct countries; (vii) Ascendis’ expectations regarding the PDUFA date for the supplemental BLA for TransCon hGH; (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.
© May 2025 Ascendis Pharma A/S.
| Investor Contacts: Scott Smith Ascendis Pharma ir@ascendispharma.com Patti Bank ICR Healthcare +1 (415) 513-1284 patti.bank@icrhealthcare.com | Media Contact: Melinda Baker Ascendis Pharma media@ascendispharma.com |
FINANCIAL TABLES FOLLOW
| Ascendis Pharma A/S Consolidated Statements of Profit or (Loss) and Comprehensive Income / (Loss) (In EUR'000s, except share and per share data) | Three Months Ended March 31, | |||||||
| 2025 | 2024 | |||||||
| Consolidated Statement of Profit or (Loss) | ||||||||
| Revenue | 100,954 | 95,894 | ||||||
| Cost of sales | 17,517 | 7,569 | ||||||
| Gross profit | 83,437 | 88,325 | ||||||
| Research and development expenses | 86,603 | 70,687 | ||||||
| Selling, general, and administrative expenses | 101,046 | 66,783 | ||||||
| Operating profit/(loss) | (104,212 | ) | (49,145 | ) | ||||
| Share of profit/(loss) of associates | 26,579 | (5,796 | ) | |||||
| Finance income | 28,854 | 3,575 | ||||||
| Finance expenses | 44,786 | 77,161 | ||||||
| Profit/(loss) before tax | (93,565 | ) | (128,527 | ) | ||||
| Income taxes (expenses) | (1,061 | ) | (2,508 | ) | ||||
| Net profit/(loss) for the period | (94,626 | ) | (131,035 | ) | ||||
| Attributable to owners of the Company | (94,626 | ) | (131,035 | ) | ||||
| Basic and diluted earnings/(loss) per share | ||||||||
| Number of shares used for calculation (basic and diluted) | 60,018,550 | 56,883,257 | ||||||
| Consolidated Statement of Comprehensive Income or (Loss) | ||||||||
| Net profit/(loss) for the period | (94,626 | ) | (131,035 | ) | ||||
| Other comprehensive income/(loss) | ||||||||
| Items that may be reclassified subsequently to profit or (loss): | ||||||||
| Exchange differences on translating foreign operations | (75 | ) | 63 | |||||
| Other comprehensive income/(loss) for the period, net of tax | (75 | ) | 63 | |||||
| Total comprehensive income/(loss) for the period, net of tax | (94,701 | ) | (130,972 | ) | ||||
| Attributable to owners of the Company | (94,701 | ) | (130,972 | ) | ||||
| Ascendis Pharma A/S Consolidated Statements of Financial Position (In EUR'000s) | March 31, 2025 | December 31, 2024 | ||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 3,909 | 4,028 | ||||||
| Property, plant and equipment | 92,447 | 98,714 | ||||||
| Investments in associates | 40,938 | 13,575 | ||||||
| Other receivables | 2,657 | 2,317 | ||||||
| 139,951 | 118,634 | |||||||
| Current assets | ||||||||
| Inventories | 293,071 | 295,609 | ||||||
| Trade receivables | 66,685 | 166,280 | ||||||
| Income tax receivables | 1,614 | 1,775 | ||||||
| Other receivables | 8,522 | 9,385 | ||||||
| Prepayments | 33,672 | 28,269 | ||||||
| Cash and cash equivalents | 517,923 | 559,543 | ||||||
| 921,487 | 1,060,861 | |||||||
| Total assets | 1,061,438 | 1,179,495 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 8,187 | 8,149 | ||||||
| Distributable equity | (197,994 | ) | (113,855 | ) | ||||
| Total equity | (189,807 | ) | (105,706 | ) | ||||
| Non-current liabilities | ||||||||
| Borrowings | 357,312 | 365,080 | ||||||
| Contract liabilities | 692 | 5,000 | ||||||
| Deferred tax liabilities | 7,733 | 7,258 | ||||||
| 365,737 | 377,338 | |||||||
| Current liabilities | ||||||||
| Convertible notes, matures in April 2028 | ||||||||
| Borrowings | 449,562 | 458,207 | ||||||
| Derivative liabilities | 174,581 | 150,670 | ||||||
| 624,143 | 608,877 | |||||||
| Other current liabilities | ||||||||
| Borrowings | 40,398 | 33,329 | ||||||
| Contract liabilities | 1,190 | 936 | ||||||
| Trade payables and accrued expenses | 84,370 | 96,394 | ||||||
| Other liabilities | 38,062 | 67,956 | ||||||
| Income tax payables | 1,573 | 1,222 | ||||||
| Provisions | 95,772 | 99,149 | ||||||
| 261,365 | 298,986 | |||||||
| 885,508 | 907,863 | |||||||
| Total liabilities | 1,251,245 | 1,285,201 | ||||||
| Total equity and liabilities | 1,061,438 | 1,179,495 | ||||||
FAQ
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