Full Press Release Details
Ascendis Pharma Reports Third Quarter 2024 Financial Results
YORVIPATH launching in U.S. with product availability expected mid-January 2025; ex-U.S. YORVIPATH revenue of 8.5 million in Q3
TransCon CNP NDA submission for
achondroplasia planned for Q1 2025 followed by MAA submission planned for Q3 2025
SKYTROFA Q3 revenue of
47.2 million 60%+ year-over-year volume growth offset by current and prior period sales deductions
year 2024 SKYTROFA revenue excluding sales deductions related to prior years expected to be 200 - 220 million, and full year 2024 operating expenses of approximately 600 million
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, November 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
Select Highlights & Anticipated 2024 Milestones
(lonapegsomatropin, marketed as SKYTROFA)
(palopegteriparatide, marketed as YORVIPATH)
Third Quarter 2024 Financial Results
Total revenue for the third quarter of 2024 was 57.8 million, compared to 48.0 million during the same period for 2023. The
year-over-year increase in total revenue was primarily attributable to revenue contribution of 8.5 million from YORVIPATH following commercial launch in the first quarter of 2024. Non-product
revenue was 2.1 million in the third quarter of 2024, compared to 1.1 million for the same period for 2023.
| 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 73.5 million, compared to
111.4 million during the same period in 2023. The decline was largely tied to lower external development costs across for TransCon hGH, TransCon PTH, and TransCon CNP as well as the Eyconis
Selling, general, and administrative (SG&A) expenses for the third quarter of 2024 were
69.8 million, compared to 63.6 million during the same period in 2023. The increase was primarily due to higher employee costs, including the impact from commercial expansion.
Total operating expenses for the third quarter of 2024 were 143.4 million compared to 175.1 million during the same period in 2023.
Net finance income for the third quarter of 2024 was 2.9 million compared to a net finance expense
of 20.4 million during the same period in 2023. The change was primarily tied the impact of currency fluctuations.
For the third quarter of
2024, Ascendis Pharma reported a net loss of 99.2 million, or 1.72 per share (basic and diluted) compared to a net loss of 162.2 million, or 2.88 per share (basic and diluted) for the same period in 2023.
As of September 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling 625.5 million compared to
399.4 million as of December 31, 2023. As of September 30, 2024, Ascendis Pharma had 60,642,144 ordinary shares outstanding, including 881,730 ordinary shares represented by ADSs held by the company.
Conference Call and Webcast Information
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.
| Investor Contacts: | Media Contact: | |||
| Scott Smith | Melinda Baker | |||
| Ascendis Pharma | Ascendis Pharma | |||
| ir@ascendispharma.com | +1 (650) 709-8875 | |||
| media@ascendispharma.com |
FINANCIAL TABLES FOLLOW
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 | ) |
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 |