Full Press Release Details
Ascendis Pharma Reports First Quarter 2024 Financial Results
Rollout of YORVIPATH initiated in Germany and Austria, with an
estimated 55 doctors writing prescriptions and ~100 patients receiving commercial product as of March 31
TransConTM PTH (palopegteriparatide) PDUFA date of
May 14, 2024, for adults with hypoparathyroidism. If approved, U.S. launch planned in Q3
CNP (navepegritide) pivotal ApproaCH Trial on track for topline results in Q4 2024
SKYTROFA Q1 revenue more than doubled year-over-year to 65 million; Q1 operating expenses fell by 20% year-over-year to
Ascendis remains on track for achieving full-year 2024 SKYTROFA revenue of
320 to 340 million and full year 2024 operating expenses of 600 million
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, May 2, 2024 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for
the first quarter ended March 31, 2024, and provided a business update.
With SKYTROFA revenue more than doubling in the U.S. compared to the
first quarter of 2023, and our successful initial launch of YORVIPATH in Germany and Austria, we believe Ascendis is on the path to achieving sustainable growth and operating cash flow breakeven on a quarterly basis by the end of 2024, said
Jan Mikkelsen, Ascendis Pharma s President and Chief Executive Officer. Our achievements this quarter give me further confidence that all elements are in place to deliver three independent Endocrinology Rare Disease blockbuster products
and a strong pipeline in larger therapeutic areas such as Oncology, Ophthalmology, and Metabolic Diseases as outlined in Vision 2030.
Highlights & Anticipated 2024 Milestones
(lonapegsomatropin, approved as SKYTROFA in the U.S., EU, European Economic Area (EEA) countries, and Great Britain)
(palopegteriparatide, approved as YORVIPATH in the EU, EEA countries, and Great Britain)
First Quarter 2024 Financial Results
Total revenue for the first quarter of 2024 was 95.9 million compared to 33.6 million during the same period for 2023. The increase was
primarily attributable to higher SKYTROFA revenue of 65.0 million compared to 31.6 million in the same period last year and non-cash license revenue of 24.8 million related to
the license agreement with Eyconis in January 2024.
| Total Revenue (In EUR 000s) | Three Months Ended March 31, | |||||||
| 2024 | 2023 | |||||||
| Revenue from external customers | ||||||||
| Commercial sale of products | 66,499 | 31,551 | ||||||
| Licenses | 24,770 | 614 | ||||||
| Other | 4,625 | 1,424 | ||||||
| Total revenue from external customers | 95,894 | 33,589 |
Research and development (R&D) costs for the first quarter of 2024 were 70.7 million compared to
106.1 million during the same period in 2023. The 33% decline was largely tied to lower external development costs for TransCon hGH, TransCon PTH (including a reversal of prior period write-downs of
pre-launch inventories) and Oncology programs, partially offset by an increase in TransCon CNP costs.
general, and administrative (SG&A) expenses for the first quarter of 2024 were 66.8 million compared to 66.5 million during the same period in 2023. Higher employee costs, including the impact from commercial expansion,
partly offset by lower external pre-launch and administrative expenses.
Total operating expenses for the first
quarter of 2024 were 137.5 million compared to 172.7 million during the same period in 2023.
Net finance expenses for the first
quarter of 2024 were 73.6 million compared to a net finance income of 35.3 million during the same period in 2023.
quarter of 2024, Ascendis Pharma reported a net loss of 131.0 million, or 2.30 per share (basic and diluted) compared to a net loss of 110.9 million, or 1.98 per share (basic and diluted) for the same period in
As of March 31, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling 320.2 million compared to
399.4 million as of December 31, 2023. As of March 31, 2024, Ascendis Pharma had 58,224,419 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 first 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) TransCon PTH s PDUFA date of May 14, 2024, (ii) the commercial launch of TransCon PTH in the U.S., if approved, (iii) the timing of topline results from the ApproaCH Trial, (iv) Ascendis expectations regarding full
year 2024 revenue for SKYTROFA, (v) Ascendis ability to fulfill its strategic goals to deliver three independent Endocrinology Rare Disease blockbuster products and a strong pipeline in larger therapeutic areas such as Oncology,
Ophthalmology, and Metabolic Diseases, (vi) Ascendis plan to submit a supplemental Biologics License Application for SKYTROFA for adult GHD in the third quarter of 2024, (vii) the timing of topline results from the Phase 2 trial in Turner
syndrome, (viii) the timing of topline data from the ApproaCH Trial, (ix) Ascendis plan to submit a New Drug Application for TransCon CNP for children with achondroplasia, (x) Ascendis ability to initiate and complete
enrollment in the COACH Trial, (xi) the timing of topline data from Week 26 of the COACH Trial, (xii) Ascendis plan to present initial data from the Phase 1/2 IL-Believe Trial,
(xiii) Ascendis plan to provide a clinical update from the Phase 2 portion of indication-specific, dose expansion cohorts of the IL Believe trial, (xiv) Ascendis expectations regarding its total operating expenses for 2024,
(xv) Ascendis expectation that it will be operating cash flow breakeven on a quarterly basis by the end of 2024, (xvi) Ascendis belief that it is on a path to achieving sustainable growth and that all elements are in place to deliver
three independent Endocrinology Rare Disease blockbuster products, (xvii) Ascendis ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xviii) 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. May 2024 Ascendis Pharma A/S.
| Investor Contacts: | Media Contact: | |
| Tim Lee | Melinda Baker | |
| Ascendis Pharma | Ascendis Pharma | |
| +1 (650) 374-6343 | +1 (650) 709-8875 | |
| tle@ascendispharma.com | media@ascendispharma.com | |
| ir@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, | ||||||||
| 2024 | 2023 | |||||||
| Consolidated Statement of Profit or Loss | ||||||||
| Revenue | 95,894 | 33,589 | ||||||
| Cost of sales | 7,569 | 4,621 | ||||||
| Gross profit | 88,325 | 28,968 | ||||||
| Research and development costs | 70,687 | 106,114 | ||||||
| Selling, general and administrative expenses | 66,783 | 66,539 | ||||||
| Operating profit/(loss) | (49,145 | ) | (143,685 | ) | ||||
| Share of profit/(loss) of associate | (5,796 | ) | (1,227 | ) | ||||
| Finance income | 3,575 | 45,135 | ||||||
| Finance expenses | 77,161 | 9,840 | ||||||
| Profit/(loss) before tax | (128,527 | ) | (109,617 | ) | ||||
| Income taxes/(expenses) | (2,508 | ) | (1,297 | ) | ||||
| Net profit/(loss) for the period | (131,035 | ) | (110,914 | ) | ||||
| Attributable to owners of the Company | (131,035 | ) | (110,914 | ) | ||||
| Basic and diluted earnings/(loss) per share | (2.30 | ) | (1.98 | ) | ||||
| Number of shares used for calculation (basic and diluted) | 56,883,257 | 56,091,927 | ||||||
| Consolidated Statement of Comprehensive Income or (Loss) | ||||||||
| Net profit/(loss) for the period | (131,035 | ) | (110,914 | ) | ||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||
| Exchange differences on translating foreign operations | 63 | (787 | ) | |||||
| Other comprehensive income/(loss) for the period, net of tax | 63 | (787 | ) | |||||
| Total comprehensive income/(loss) for the period, net of tax | (130,972 | ) | (111,701 | ) | ||||
| Attributable to owners of the Company | (130,972 | ) | (111,701 | ) |
Consolidated Statements of Financial Position
| March 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 4,301 | 4,419 | ||||||
| Property, plant and equipment | 107,164 | 110,634 | ||||||
| Investment in associates | 24,797 | 5,686 | ||||||
| Other receivables | 2,129 | 2,127 | ||||||
| 138,391 | 122,866 | |||||||
| Current assets | ||||||||
| Inventories | 232,681 | 208,931 | ||||||
| Trade receivables | 41,092 | 35,874 | ||||||
| Income tax receivables | 742 | 802 | ||||||
| Other receivables | 26,857 | 19,097 | ||||||
| Prepayments | 42,502 | 38,578 | ||||||
| Marketable securities | 7,275 | |||||||
| Cash and cash equivalents | 320,239 | 392,164 | ||||||
| 664,113 | 702,721 | |||||||
| Total assets | 802,504 | 825,587 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 7,818 | 7,749 | ||||||
| Distributable equity | (245,997 | ) | (153,446 | ) | ||||
| Total equity | (238,179 | ) | (145,697 | ) | ||||
| Non-current liabilities | ||||||||
| Borrowings | 229,627 | 222,996 | ||||||
| Contract liabilities | 5,000 | 5,949 | ||||||
| Deferred tax liabilities | 7,085 | 5,830 | ||||||
| 241,712 | 234,775 | |||||||
| Current liabilities | ||||||||
| Convertible notes, matures in April 2028 | ||||||||
| Borrowings | 424,984 | 407,095 | ||||||
| Derivative liabilities | 197,291 | 143,296 | ||||||
| 622,275 | 550,391 | |||||||
| Other current liabilities | ||||||||
| Borrowings | 14,403 | 14,174 | ||||||
| Contract liabilities | 1,183 | 1,184 | ||||||
| Trade payables and accrued expenses | 94,526 | 94,566 | ||||||
| Other liabilities | 22,698 | 41,176 | ||||||
| Income tax payables | 3,336 | 2,299 | ||||||
| Provisions | 40,550 | 32,719 | ||||||
| 176,696 | 186,118 | |||||||
| 798,971 | 736,509 | |||||||
| Total liabilities | 1,040,683 | 971,284 | ||||||
| Total equity and liabilities | 802,504 | 825,587 |