Full Press Release Details
Ascendis Pharma Reports Second Quarter 2024 Financial Results
YORVIPATH approved by U.S. Food & Drug Administration (FDA) as the first and only treatment of
hypoparathyroidism in adults
TransCon CNP (navepegritide) pivotal ApproaCH Trial topline results expected in the coming
SKYTROFA Q2 revenue of 26 million 134%
year-over-year volume growth offset by negative adjustment of 27 million, resetting market access for continued growth
Revising full year 2024 SKYTROFA revenue outlook to 220 - 240 million
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, September 3, 2024 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results
for the second quarter ended June 30, 2024, and provided a business update.
The recent FDA approval of YORVIPATH demonstrates why our
unrelenting focus on helping patients suffering from hypoparathyroidism and other serious diseases with considerable unmet need is so important for Ascendis, said Jan Mikkelsen, Ascendis Pharma s President and Chief Executive Officer.
Already, two out of our three Endocrine Rare Disease TransCon product candidates have been approved by the FDA and European Commission. Our first, SKYTROFA, has achieved U.S. market value leadership, and, we believe, now with broader market
access, remains well positioned to reach blockbuster status in the U.S. alone. Looking forward, we are preparing for our second U.S. launch with YORVIPATH and are on track to report pivotal data in the coming weeks for our third TransCon product
candidate, TransCon CNP.
Select Highlights & Anticipated 2024 Milestones
(lonapegsomatropin, marketed as SKYTROFA)
(palopegteriparatide, marketed as YORVIPATH)
Second Quarter 2024 Financial Results
Total revenue for the second quarter of 2024 was 36.0 million, compared to 47.4 million during the same period for 2023. Results in the
quarter were primarily impacted by a negative adjustment to prior periods estimates and assumptions for sales deductions of 27.1 million, where 19.5 million and 7.6 million were attributable to the three months
ended March 31, 2024, and periods prior to January 1, 2024, respectively. This was partially offset by increased demand for SKYTROFA in the U.S. and revenue contribution from YORVIPATH. In addition,
non-product revenue was 4.6 million in the second quarter of 2024, compared to 11.5 million during the same period for 2023.
| Total Revenue (In EUR 000s) | Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue from external customers | ||||||||||||||||
| Commercial sale of products | 31,389 | 35,895 | 97,888 | 67,446 | ||||||||||||
| Licenses | 869 | 589 | 25,639 | 1,203 | ||||||||||||
| Other | 3,740 | 10,909 | 8,365 | 12,333 | ||||||||||||
| Total revenue from external customers | 35,998 | 47,393 | 131,892 | 80,982 |
Research and development (R&D) costs for the second quarter of 2024 were 83.5 million, compared to
105.0 million during the same period in 2023. The decline was largely tied to lower external development costs for TransCon TLR 7/8 Agonist and lower costs for TransCon PTH, as well as lower employee costs as a result of the Eyconis spin-off.
Selling, general, and administrative (SG&A) expenses for the second quarter of 2024 were
74.3 million, compared to 70.3 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 second quarter of 2024 were 157.8 million compared to
175.3 million during the same period in 2023.
Net finance income for the second quarter of 2024 was 29.4 million compared to
a net finance income of 26.4 million during the same period in 2023.
For the second quarter of 2024, Ascendis Pharma reported a net loss of
109.4 million, or 1.91 per share (basic and diluted) compared to a net loss of 121.4 million, or 2.16 per share (basic and diluted) for the same period in 2023.
As of June 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling 258.7 million compared to
399.4 million as of December 31, 2023. As of June 30, 2024, Ascendis Pharma had 58,231,484 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 second 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
timing of topline results from the ApproaCH Trial, (ii) Ascendis expectations regarding full year 2024 SKYTROFA revenue, (iii) Ascendis expectations regarding SKYTROFA s potential to reach blockbuster status,
(iv) Ascendis plan to submit a supplemental Biologics License Application for SKYTROFA for adult growth hormone deficiency in the third quarter of 2024, (v) the timing of topline results from the Phase 2 trial of TransCon hGH in Turner
syndrome, (vi) Ascendis plan to submit a New Drug Application for TransCon CNP for children with achondroplasia, (vii) Ascendis expectations regarding completing manufacturing of YORVIPATH commercial product for the U.S. market
and the timing of initial supply, (viii) dialogue with FDA regarding commercialization of existing YORVIPATH manufactured product and, if agreed,
the potential timing of introduction, (ix) Ascendis expectations regarding initial revenue in France from YORVIPATH, (x) Ascendis plan to complete enrollment in the COACH
Trial, (xi) the timing of topline Week 26 data from the COACH Trial, (xii) the timing of initiating the teACH Phase 2 trial in adolescents, (xiii) Ascendis plan to present initial results from the Phase 2 dose expansion cohort
of the IL-Believe Trial, (xiv) Ascendis expectations regarding its total operating expenses for 2024, (xv) Ascendis expectation to be operating cash flow breakeven on a quarterly basis in 2024
or 2025, (xvi) Ascendis ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xvii) 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.
Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA , and YORVIPATH are trademarks owned by the Ascendis Pharma
group. September 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
Consolidated Statements of Profit
or Loss and Comprehensive Income / (Loss)
| (In EUR 000s, except share and per share data) | Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Consolidated Statement of Profit or Loss | ||||||||||||||||
| Revenue | 35,998 | 47,393 | 131,892 | 80,982 | ||||||||||||
| Cost of sales | 11,465 | 12,929 | 19,034 | 17,551 | ||||||||||||
| Gross profit | 24,533 | 34,464 | 112,858 | 63,431 | ||||||||||||
| Research and development costs | 83,478 | 105,021 | 154,165 | 211,134 | ||||||||||||
| Selling, general and administrative expenses | 74,312 | 70,281 | 141,095 | 136,820 | ||||||||||||
| Operating profit/(loss) | (133,257 | ) | (140,838 | ) | (182,402 | ) | (284,523 | ) | ||||||||
| Share of profit/(loss) of associate | (5,322 | ) | (7,451 | ) | (11,118 | ) | (8,677 | ) | ||||||||
| Finance income | 49,052 | 35,761 | 14,395 | 80,374 | ||||||||||||
| Finance expenses | 19,624 | 9,334 | 58,553 | 18,652 | ||||||||||||
| Profit/(loss) before tax | (109,151 | ) | (121,862 | ) | (237,678 | ) | (231,478 | ) | ||||||||
| Income taxes/(expenses) | (229 | ) | 429 | (2,737 | ) | (868 | ) | |||||||||
| Net profit/(loss) for the period | (109,380 | ) | (121,433 | ) | (240,415 | ) | (232,346 | ) | ||||||||
| Attributable to owners of the Company | (109,380 | ) | (121,433 | ) | (240,415 | ) | (232,346 | ) | ||||||||
| Basic and diluted earnings/(loss) per share | (1.91 | ) | (2.16 | ) | (4.21 | ) | (4.14 | ) | ||||||||
| Number of shares used for calculation (basic and diluted) | 57,345,613 | 56,218,257 | 57,114,435 | 56,155,441 | ||||||||||||
| (EUR 000) | ||||||||||||||||
| Consolidated Statement of Comprehensive Income or (Loss) | ||||||||||||||||
| Net profit/(loss) for the period | (109,380 | ) | (121,433 | ) | (240,415 | ) | (232,346 | ) | ||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Exchange differences on translating foreign operations | 15 | (1,016 | ) | 78 | (1,803 | ) | ||||||||||
| Other comprehensive income/(loss) for the period, net of tax | 15 | (1,016 | ) | 78 | (1,803 | ) | ||||||||||
| Total comprehensive income/(loss) for the period, net of tax | (109,365 | ) | (122,449 | ) | (240,337 | ) | (234,149 | ) | ||||||||
| Attributable to owners of the Company | (109,365 | ) | (122,449 | ) | (240,337 | ) | (234,149 | ) |
Consolidated Statements of Financial Position
| (In EUR 000s) | June 30, 2024 | December 31, 2023 | ||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 4,186 | 4,419 | ||||||
| Property, plant and equipment | 104,041 | 110,634 | ||||||
| Investment in associates | 20,564 | 5,686 | ||||||
| Other receivables | 2,186 | 2,127 | ||||||
| 130,977 | 122,866 | |||||||
| Current assets | ||||||||
| Inventories | 251,199 | 208,931 | ||||||
| Trade receivables | 49,163 | 35,874 | ||||||
| Income tax receivables | 1,841 | 802 | ||||||
| Other receivables | 29,679 | 19,097 | ||||||
| Prepayments | 36,743 | 38,578 | ||||||
| Marketable securities | 7,275 | |||||||
| Cash and cash equivalents | 258,696 | 392,164 | ||||||
| 627,321 | 702,721 | |||||||
| Total assets | 758,298 | 825,587 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 7,819 | 7,749 | ||||||
| Distributable equity | (328,952 | ) | (153,446 | ) | ||||
| Total equity | (321,133 | ) | (145,697 | ) | ||||
| Non-current liabilities | ||||||||
| Borrowings | 219,052 | 222,996 | ||||||
| Contract liabilities | 5,000 | 5,949 | ||||||
| Deferred tax liabilities | 7,644 | 5,830 | ||||||
| 231,696 | 234,775 | |||||||
| Current liabilities | ||||||||
| Convertible notes, matures in April 2028 | ||||||||
| Borrowings | 432,190 | 407,095 | ||||||
| Derivative liabilities | 159,059 | 143,296 | ||||||
| 591,249 | 550,391 | |||||||
| Other current liabilities | ||||||||
| Borrowings | 21,397 | 14,174 | ||||||
| Contract liabilities | 1,293 | 1,184 | ||||||
| Trade payables and accrued expenses | 99,527 | 94,566 | ||||||
| Other liabilities | 26,411 | 41,176 | ||||||
| Income tax payables | 1,090 | 2,299 | ||||||
| Provisions | 106,768 | 32,719 | ||||||
| 256,486 | 186,118 | |||||||
| 847,735 | 736,509 | |||||||
| Total liabilities | 1,079,431 | 971,284 | ||||||
| Total equity and liabilities | 758,298 | 825,587 |