Ascendis Pharma Reports Third Quarter 2024 Financial Results
Ascendis Pharma reported Q3 2024 financial results with total revenue of €57.8 million, including SKYTROFA revenue of €47.2 million and YORVIPATH ex-U.S. revenue of €8.5 million. The company plans U.S. YORVIPATH launch with product availability in mid-January 2025. TransCon CNP NDA submission for achondroplasia is planned for Q1 2025. A new collaboration with Novo Nordisk was announced for metabolic and cardiovascular diseases. Full-year 2024 SKYTROFA revenue guidance is €200-220 million, with operating expenses projected at €600 million. Cash position stands at €626 million as of September 30, 2024.
Ascendis Pharma ha riportato i risultati finanziari del terzo trimestre 2024 con un fatturato totale di 57,8 milioni di euro, inclusi i ricavi da SKYTROFA pari a 47,2 milioni di euro e i ricavi da YORVIPATH al di fuori degli Stati Uniti pari a 8,5 milioni di euro. L'azienda prevede il lancio di YORVIPATH negli Stati Uniti con disponibilità del prodotto a metà gennaio 2025. La presentazione della NDA per TransCon CNP per l'achondroplasia è pianificata per il primo trimestre del 2025. È stata annunciata una nuova collaborazione con Novo Nordisk per malattie metaboliche e cardiovascolari. La previsione di fatturato per l'anno intero 2024 per SKYTROFA è compresa tra 200 e 220 milioni di euro, con spese operative previste di 600 milioni di euro. La posizione di liquidità ammonta a 626 milioni di euro al 30 settembre 2024.
Ascendis Pharma reportó los resultados financieros del tercer trimestre de 2024 con ingresos totales de 57,8 millones de euros, incluyendo ingresos de SKYTROFA por 47,2 millones de euros y ingresos de YORVIPATH fuera de EE.UU. de 8,5 millones de euros. La compañía planea lanzar YORVIPATH en EE.UU. con disponibilidad del producto a mediados de enero de 2025. La presentación de la NDA para TransCon CNP para la acondroplasia está programada para el primer trimestre de 2025. Se anunció una nueva colaboración con Novo Nordisk para enfermedades metabólicas y cardiovasculares. La guía de ingresos de SKYTROFA para todo el año 2024 es de 200 a 220 millones de euros, con gastos operativos proyectados en 600 millones de euros. La posición de efectivo asciende a 626 millones de euros a partir del 30 de septiembre de 2024.
Ascendis Pharma는 2024년 3분기 재무 결과를 발표했으며, 총 수익은 5780만 유로로, SKYTROFA의 수익은 4720만 유로, 미국 외의 YORVIPATH 수익은 850만 유로에 달합니다. 이 회사는 2025년 1월 중순에 제품을 출시할 계획입니다. TransCon CNP의 사고증가증에 대한 NDA 제출은 2025년 1분기로 계획되어 있습니다. 대사 및 심혈관 질환에 대한 Novo Nordisk와의 새로운 협력도 발표되었습니다. 2024년 전체 연도에 대한 SKYTROFA의 수익 가이드는 2억에서 2억 2000만 유로로 예상되며, 운영 비용은 6억 유로로 예상됩니다. 2024년 9월 30일 기준 현금 보유액은 6억 2600만 유로입니다.
Ascendis Pharma a publié ses résultats financiers pour le troisième trimestre 2024, avec un chiffre d'affaires total de 57,8 millions d'euros, comprenant des revenus de SKYTROFA de 47,2 millions d'euros et des revenus de YORVIPATH hors des États-Unis de 8,5 millions d'euros. L'entreprise prévoit le lancement de YORVIPATH aux États-Unis avec une disponibilité du produit à la mi-janvier 2025. La soumission de la NDA pour TransCon CNP pour l'achondroplasie est prévue pour le premier trimestre 2025. Une nouvelle collaboration avec Novo Nordisk a été annoncée pour des maladies métaboliques et cardiovasculaires. Les prévisions de revenus pour l'année 2024 pour SKYTROFA se situent entre 200 et 220 millions d'euros, avec des dépenses d'exploitation prévues à 600 millions d'euros. La position de trésorerie s'élève à 626 millions d'euros au 30 septembre 2024.
Ascendis Pharma hat die Finanzzahlen für das dritte Quartal 2024 veröffentlicht, mit einem Gesamtumsatz von 57,8 Millionen Euro, einschließlich Einnahmen aus SKYTROFA in Höhe von 47,2 Millionen Euro und Einnahmen aus YORVIPATH außerhalb der USA von 8,5 Millionen Euro. Das Unternehmen plant die Einführung von YORVIPATH in den USA mit Produktverfügbarkeit Mitte Januar 2025. Die Einreichung des NDA für TransCon CNP zur Behandlung von Achondroplasie ist für das erste Quartal 2025 vorgesehen. Eine neue Zusammenarbeit mit Novo Nordisk wurde für Stoffwechsel- und Herz-Kreislauf-Erkrankungen angekündigt. Die Umsatzprognose für das Gesamtjahr 2024 für SKYTROFA liegt zwischen 200 und 220 Millionen Euro, mit geplanten Betriebskosten von 600 Millionen Euro. Die Liquiditätsposition beträgt zum 30. September 2024 626 Millionen Euro.
- Q3 revenue increased to €57.8M from €48.0M YoY
- YORVIPATH ex-U.S. revenue grew 60% QoQ to €8.5M
- Strategic collaboration with Novo Nordisk includes potential payments up to €285M plus royalties
- Cash position strengthened to €626M from €399M at end of 2023
- R&D costs decreased to €73.5M from €111.4M YoY
- Net loss of €99.2M in Q3 2024
- SKYTROFA revenue growth impacted by higher sales deductions
- Operating expenses expected to reach €600M for 2024
- SG&A expenses increased to €69.8M from €63.6M YoY
Insights
The Q3 results show mixed performance.
Operating expenses decreased to
The pipeline progress is significant with three key developments: 1) YORVIPATH's imminent U.S. launch in January 2025, 2) TransCon CNP's planned NDA submission for achondroplasia in Q1 2025 and 3) positive data from the pivotal ApproaCH Trial. The Novo Nordisk collaboration for metabolic diseases, particularly the once-monthly GLP-1 receptor agonist, represents major validation of the TransCon platform technology.
The company now has three endocrinology rare disease programs with demonstrated clinical differentiation and blockbuster potential. The expansion into metabolic diseases through the Novo partnership could significantly broaden the platform's commercial potential.
– YORVIPATH launching in U.S. with product availability expected mid-January 2025; ex-U.S. YORVIPATH revenue of
– TransCon CNP NDA submission for achondroplasia planned for Q1 2025 followed by MAA submission planned for Q3 2025
– SKYTROFA Q3 revenue of
– Full year 2024 SKYTROFA revenue excluding sales deductions related to prior years expected to be
– Novo Nordisk collaboration for the development of product candidates in metabolic and cardiovascular diseases, including a once-monthly GLP-1 receptor agonist, signed last week, seeking to close before the end of 2024
– Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the third quarter ended September 30, 2024, and provided a business update.
“2024 has been another transformative year for Ascendis. Now, all three of our three endocrinology rare disease programs have delivered clinically differentiated pivotal data, each demonstrating potential ability to address major unmet medical needs and the potential for each to achieve blockbuster status. We are ready and very excited about launching YORVIPATH in the U.S. with product availability expected in mid-January of 2025,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “In addition, our new partnership with Novo Nordisk highlights our ability to extend the success of our TransCon platform and positions Ascendis to benefit patients and capture significant value in this large, high volume therapeutic areas.”
Select Highlights & Anticipated 2024 Milestones
- TransCon hGH:
(lonapegsomatropin, marketed as SKYTROFA)- SKYTROFA revenue for the third quarter of 2024 totaled
€47.2 million compared to€47.0 million during the same period in 2023. Volume growth was offset by higher sales deductions and a negative adjustment to prior period sales deductions of€2.5 million . - SKYTROFA revenue for the first nine months of 2024 totaled
€138.5 million , a21% year-over-year increase compared to€114.4 million during the same period of 2023. Volume growth was partially offset by higher sales deductions. In addition, sales deductions attributable to periods prior to January 1, 2024 totaled€9.3 million . - Submitted U.S. Food & Drug Administration (FDA) supplemental Biologics License Application for TransCon hGH for the treatment of adults with growth hormone deficiency.
- Topline results from Phase 2 New InsiGHTS Trial in Turner syndrome expected in the fourth quarter of 2024.
- Expect to initiate a basket trial evaluating SKYTROFA in other established daily growth hormone indications in the first half of 2025.
- SKYTROFA revenue for the third quarter of 2024 totaled
- TransCon PTH:
(palopegteriparatide, marketed as YORVIPATH)- YORVIPATH launching in U.S. with our expanded U.S. field teams engaging with health care providers, our Ascendis Signature Access Program accepting prescriptions and enrolling patients starting in December in preparation for product availability in mid-January 2025
- Third quarter YORVIPATH revenue outside the U.S. totaled
€8.5 million , a sequential quarter-over-quarter revenue increase of more than60% , reflecting growing physician and patient demand with now over 600 patients on treatment, partially offset by accruals reflecting the end of the free pricing period in the third quarter. Final pricing in Germany is expected to be completed next year.
- TransCon CNP
(navepegritide)- Announced positive topline data from pivotal ApproaCH Trial with children with achondroplasia (ages 2-11 years) treated with once-weekly TransCon CNP.
- Plan to submit New Drug Application (NDA) to the FDA for TransCon CNP for the treatment of children with achondroplasia during the first quarter of 2025 and a Marketing Authorisation Application (MAA) for the treatment of children with achondroplasia to the European Medicines Agency during the third quarter of 2025.
- Expect topline Week 26 data from COACH, the combination TransCon hGH and TransCon CNP trial of children with achondroplasia (ages 2-11 years) in the second quarter of 2025.
- Oncology Programs
- Presented first results from platinum-resistant ovarian cancer (PROC) cohort of the Phase 1/2 IL-Believe Trial at ESMO 2024. Initial data suggest clinical activity in heavily pre-treated PROC patients and that TransCon IL-2 β/γ in combination with chemotherapy was generally well-tolerated.
- Recently, we closed enrollment to dose expansion cohorts involving TransCon TLR7/8 Agonist in the transcendIT-101 and IL Believe trials to prioritize our efforts on TransCon IL-2 b/g.
- Strategic Collaboration
- In November, granted Novo Nordisk A/S an exclusive, multi-product, worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary products in metabolic diseases and a product-by-product exclusive license in cardiovascular diseases. The lead program in the collaboration is a once-monthly GLP-1 receptor agonist product candidate that will initially target obesity and type 2 diabetes.
- For the lead program, Ascendis will be eligible to receive total payments of up to
$285 million in upfront, development, and regulatory milestone payments, plus sales-based milestone payments and escalating tiered, mid-single digit royalties on global net sales. - Novo Nordisk will be responsible for Ascendis’ early development costs as well as for clinical development, regulatory, commercial manufacturing, and commercialization activities.
- Financial Update and Outlook Based on Current Plans
- As of September 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities, totaling
€626 million , compared to€399 million as of December 31, 2023. - Full year 2024 SKYTROFA revenue excluding sales deductions related to prior years expected to be
€200 -€220 million . - Expect total operating expenses (SG&A and R&D) to be approximately
€600 million for 2024.
- As of September 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities, totaling
Third Quarter 2024 Financial Results
Total revenue for the third quarter of 2024 was
| Total Revenue (In EUR'000s) | Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||
| Revenue from external customers | ||||||||||
| Commercial sale of products | 55,710 | 46,968 | 153,598 | 114,414 | ||||||
| Licenses | 851 | 571 | 26,490 | 1,774 | ||||||
| Other | 1,272 | 495 | 9,637 | 12,828 | ||||||
| Total revenue from external customers | 57,833 | 48,034 | 189,725 | 129,016 | ||||||
Research and development (R&D) costs for the third quarter of 2024 were
Selling, general, and administrative (SG&A) expenses for the third quarter of 2024 were
Total operating expenses for the third quarter of 2024 were
Net finance income for the third quarter of 2024 was
For the third quarter of 2024, Ascendis Pharma reported a net loss of
As of September 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities 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 third quarter 2024 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 on this section of the Ascendis Pharma website shortly after conclusion of the event for 30 days.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. 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) the U.S. launch of YORVIPATH; (ii) the timing of NDA and MAA submissions for TransCon CNP; (iii) projections for full year 2024 SKYTROFA revenue and operating expenses; (iv) the closing of the Novo Nordisk collaboration; (v) the ability of Ascendis’ three endocrinology rare disease programs to address major unmet medical needs and achieve blockbuster status; (vi) Ascendis’ ability to extend the success of its TransCon platform and capture significant value in the areas of metabolic and cardiovascular disease; (vii) the timing of topline results from Phase 2 New InsiGHTS Trial in Turner syndrome; (viii) the initiation of a basket trial evaluating SKYTROFA in other daily growth hormone indications; (ix) the timing by which the Ascendis Signature Access Program will begin accepting prescriptions and enrolling patients; (x) the timing of final YORVIPATH pricing in Germany; (xi) the timing of topline Week 26 data from COACH, the combination TransCon hGH and TransCon CNP trial of children with achondroplasia; (xii) Ascendis’ revenues from the Novo Nordisk collaboration; (xiii) Novo Nordisk’s responsibilities under the collaboration; (xiv) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xv) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. 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. 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 7, 2024, 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.
© November 2024 Ascendis Pharma A/S.
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| 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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Consolidated Statement of Profit or (Loss) | |||||||||||||||||
| Revenue | 57,833 | 48,034 | 189,725 | 129,016 | |||||||||||||
| Cost of sales | 11,201 | 7,388 | 30,235 | 24,938 | |||||||||||||
| Gross profit | 46,632 | 40,646 | 159,490 | 104,078 | |||||||||||||
| Research and development costs | 73,544 | 111,439 | 227,708 | 322,573 | |||||||||||||
| Selling, general and administrative expenses | 69,831 | 63,614 | 210,928 | 200,435 | |||||||||||||
| Operating profit/(loss) | (96,743 | ) | (134,407 | ) | (279,146 | ) | (418,930 | ) | |||||||||
| Share of profit/(loss) of associate | (4,367 | ) | (6,794 | ) | (15,485 | ) | (15,471 | ) | |||||||||
| Finance income | 28,279 | 4,142 | 29,262 | 76,985 | |||||||||||||
| Finance expenses | 25,347 | 24,519 | 70,488 | 35,640 | |||||||||||||
| Profit/(loss) before tax | (98,178 | ) | (161,578 | ) | (335,857 | ) | (393,056 | ) | |||||||||
| Income taxes/(expenses) | (1,020 | ) | (645 | ) | (3,758 | ) | (1,513 | ) | |||||||||
| Net profit/(loss) for the period | (99,198 | ) | (162,223 | ) | (339,615 | ) | (394,569 | ) | |||||||||
| Attributable to owners of the Company | (99,198 | ) | (162,223 | ) | (339,615 | ) | (394,569 | ) | |||||||||
| Basic and diluted earnings/(loss) per share | € | (1.72 | ) | € | (2.88 | ) | € | (5.93 | ) | € | (7.02 | ) | |||||
| Number of shares used for calculation (basic and diluted) | 57,535,349 | 56,272,698 | 57,255,764 | 56,194,956 | |||||||||||||
| Consolidated Statement of Comprehensive Income or (Loss) | |||||||||||||||||
| Net profit/(loss) for the period | (99,198 | ) | (162,223 | ) | (339,615 | ) | (394,569 | ) | |||||||||
| Items that may be reclassified subsequently to profit or (loss): | |||||||||||||||||
| Exchange differences on translating foreign operations | 154 | 571 | 232 | (1,232 | ) | ||||||||||||
| Other comprehensive income/(loss) for the period, net of tax | 154 | 571 | 232 | (1,232 | ) | ||||||||||||
| Total comprehensive income/(loss) for the period, net of tax | (99,044 | ) | (161,652 | ) | (339,383 | ) | (395,801 | ) | |||||||||
| Attributable to owners of the Company | (99,044 | ) | (161,652 | ) | (339,383 | ) | (395,801 | ) | |||||||||
| Ascendis Pharma A/S Consolidated Statements of Financial Position (In EUR'000s) | September 30, 2024 | December 31, 2023 | |||||
Assets | |||||||
| Non-current assets | |||||||
| Intangible assets | 4,106 | 4,419 | |||||
| Property, plant and equipment | 97,522 | 110,634 | |||||
| Investment in associates | 16,213 | 5,686 | |||||
| Other receivables | 2,202 | 2,127 | |||||
| 120,043 | 122,866 | ||||||
| Current assets | |||||||
| Inventories | 265,433 | 208,931 | |||||
| Trade receivables | 33,098 | 35,874 | |||||
| Income tax receivables | 1,995 | 802 | |||||
| Other receivables | 15,259 | 19,097 | |||||
| Prepayments | 32,440 | 38,578 | |||||
| Marketable securities | — | 7,275 | |||||
| Cash and cash equivalents | 625,515 | 392,164 | |||||
| 973,740 | 702,721 | ||||||
| Total assets | 1,093,783 | 825,587 | |||||
| Equity and liabilities | |||||||
| Equity | |||||||
| Share capital | 8,143 | 7,749 | |||||
| Distributable equity | (105,463 | ) | (153,446 | ) | |||
| Total equity | (97,320 | ) | (145,697 | ) | |||
| Non-current liabilities | |||||||
| Borrowings | 338,930 | 222,996 | |||||
| Contract liabilities | 5,000 | 5,949 | |||||
| Deferred tax liabilities | 8,716 | 5,830 | |||||
| 352,646 | 234,775 | ||||||
| Current liabilities | |||||||
| Convertible notes, matures in April 2028 | |||||||
| Borrowings | 422,064 | 407,095 | |||||
| Derivative liabilities | 168,346 | 143,296 | |||||
| 590,410 | 550,391 | ||||||
| Other current liabilities | |||||||
| Borrowings | 27,668 | 14,174 | |||||
| Contract liabilities | 1,586 | 1,184 | |||||
| Trade payables and accrued expenses | 75,268 | 94,566 | |||||
| Other liabilities | 42,241 | 41,176 | |||||
| Income tax payables | 1,016 | 2,299 | |||||
| Provisions | 100,268 | 32,719 | |||||
| 248,047 | 186,118 | ||||||
| 838,457 | 736,509 | ||||||
| Total liabilities | 1,191,103 | 971,284 | |||||
| Total equity and liabilities | 1,093,783 | 825,587 | |||||
FAQ
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