Full Press Release Details
Ascendis Pharma Reports Fourth Quarter and Full Year 2023 Results
Launch of TransConTM PTH underway with full commercial availability in Germany
and Austria; U.S. PDUFA date of May 14, 2024
TransCon CNP pivotal ApproaCH Trial on track for topline results in Q4 2024
Total Q4 revenue of 138 million including SKYTROFA
revenue of 64 million; Q4 operating expenses of 155 million
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, February 7, 2024 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND) today announced financial
results for the fourth quarter and full year ended December 31, 2023 and provided a business update.
In 2023, we streamlined Ascendis,
including our structure, processes, and operating expense allocation, and at the same time we believe we remain on track to achieve Vision 3x3, said Jan Mikkelsen, Ascendis Pharma s President and Chief Executive Officer. SKYTROFA is
the leading growth hormone product in value in the U.S., the launch of YORVIPATH in our Europe Direct and International Markets segments
is underway beginning with Germany and Austria, and our clinical program for TransCon CNP is advancing. Ascendis is a leaner, more efficient organization in 2024, well-positioned to fulfill the strategic goals outlined in our Vision 2030, including
achieving blockbuster status for each of our three independent Endocrinology Rare Disease products and expanding our engine for future innovation.
Select 2023 Highlights & Anticipated 2024 Milestones
(lonapegsomatropin, approved as SKYTROFA in the U.S. and EU)
| Q4-2022 | Q1-2023 | Q2-2023 | Q3-2023 | Q4-2023 | ||||||||||||||||
| SKYTROFA revenue (millions) | 17 | 32 | 36 | 47 | 64 |
(palopegteriparatide, approved as YORVIPATH in the EU)
(onvapegleukin alfa)
Fourth Quarter and Full Year 2023 Financial Results
Total revenue for the fourth quarter of 2023 was 137.7 million compared to 22.9 million during the same period for 2022. The increase was
primarily attributable to the $70.0 million upfront payment from Teijin, reported in license revenue and higher SKYTROFA revenue of 64.2 million compared to 17.1 million in the same period last year. Total revenue for 2023
was 266.7 million compared to 51.2 million in 2022. The increase was primarily attributable to higher SKYTROFA revenue of 178.7 million in 2023 compared to 35.7 million last year and the $70.0 million
upfront payment from Teijin, reported in license revenue.
Research and development (R&D) costs for the fourth quarter were 90.9 million compared to
108.6 million during the same period in 2022. The decrease was tied to lower external development costs for TransCon hGH and Oncology programs. R&D costs for 2023 were 413.5 million compared to 379.6 million in
2022. The higher R&D costs in 2023 reflect an increase in TransCon CNP, Oncology and Ophthalmology program development activities and an increase in employee related costs attributable to organizational growth, partially offset by lower TransCon
hGH program development costs.
Selling, general, and administrative (SG&A) expenses for the fourth quarter were 64.0 million compared to
56.6 million during the same period in 2022. This increase was primarily due to higher employee related expenses attributable to organizational growth. SG&A expenses for 2023 were 264.4 million compared to
221.2 million in 2022. Higher SG&A expenses were primarily due to organizational growth including commercial personnel to support existing SKYTROFA sales in the U.S. and Germany, and in preparation for future product launches.
Total operating expenses for the fourth quarter were 154.9 million compared to 165.2 million during the same period in 2022. Total
operating expenses for 2023 were 677.9 million compared to 600.9 million in 2022.
Net finance expenses were 41.6 million
in the fourth quarter compared to 46.7 million in the same period in 2022. Net finance expenses were 0.2 million in 2023 compared to a net finance income of 1.7 million in 2022.
For the fourth quarter of 2023, Ascendis Pharma reported a net loss of 86.9 million, or 1.54 per share (basic and diluted) compared to a net
loss of 207.4 million, or 3.71 per share (basic and diluted) for the same period in 2022. For the full year 2023, Ascendis Pharma reported a net loss of 481.4 million, or 8.55 per share (basic and diluted) compared
to a net loss of 583.2 million, or 10.40 per share (basic and diluted) in 2022.
As of December 31, 2023, Ascendis Pharma had cash,
cash equivalents, and marketable securities totaling 399.4 million compared to 742.9 million as of December 31, 2022. As of December 31, 2023, Ascendis Pharma had 57,707,439 ordinary shares outstanding, including
1,093,054 ordinary shares represented by ADSs held by the company.
Conference Call and Webcast Information
Ascendis Pharma will also host a conference call and webcast today at 4:30 p.m. Eastern Time (ET) to discuss 2023 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 Germany 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 timing of topline results from the ApproaCH Trial, (iii) Ascendis ability to achieve Vision 3x3, (iv) Ascendis ability to fulfill its strategic goals outlined in
Vision 2030, including achieving blockbuster status for each of its three independent Endocrinology Rare Disease products and expanding its engine for future innovation, (v) Ascendis expectations regarding full year 2024 revenue for
SKYTROFA, (vi) Ascendis plan to submit a Biologics License Application for SKYTROFA for adult GHD in the second quarter of 2024, (vii) the timing of topline results from the Phase 2 trial in Turner syndrome, (viii) the launch of
TransCon PTH in the U.S., if approved, (ix) the estimated total enrollment in the Phase 2 reACHin Trial, (x) the timing of topline data from the ApproaCH Trial, (xi) Ascendis plan to submit a New Drug Application for TransCon
CNP for children with achondroplasia, (xii) the timing of topline data from Week 26 of the COACH Trial, (xiii) Ascendis plan to submit an Investigational New Drug application or similar for TransCon CNP in adults with achondroplasia,
(xiv) Ascendis plan to provide a clinical update from the Phase 2 portion of indication-specific, dose expansion cohorts of the IL Believe trial, (xv) Ascendis plan to provide a clinical update from the Phase 2 portion of
indication-specific, dose expansion cohorts in the transcendIT-101 trial during the fourth quarter of 2024, (xvi) Eyconis, Inc. s ability to develop, manufacture, and commercialize TransCon ophthalmology
assets globally, (xvii) Ascendis expectations regarding its total operating expenses for 2024, (xviii) Ascendis expectation that it will be operating cash flow breakeven on a quarterly basis by the end of 2024, (xix) Ascendis
ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xx) 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.
February 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 December 31, | Twelve Months ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | 137,703 | 22,895 | 266,718 | 51,174 | ||||||||||||
| Cost of sales | 19,457 | 5,111 | 44,395 | 12,137 | ||||||||||||
| Gross profit | 118,246 | 17,784 | 222,323 | 39,037 | ||||||||||||
| Research and development costs | 90,881 | 108,618 | 413,454 | 379,624 | ||||||||||||
| Selling, general and administrative expenses | 63,975 | 56,553 | 264,410 | 221,227 | ||||||||||||
| Operating profit / (loss) | (36,610 | ) | (147,387 | ) | (455,541 | ) | (561,814 | ) | ||||||||
| Share of profit / (loss) of associate | (2,924 | ) | (7,962 | ) | (18,395 | ) | (17,697 | ) | ||||||||
| Finance income | 22,727 | 3,305 | 43,857 | 52,181 | ||||||||||||
| Finance expenses | 64,280 | 50,027 | 44,065 | 50,487 | ||||||||||||
| Profit / (loss) before tax | (81,087 | ) | (202,071 | ) | (474,144 | ) | (577,817 | ) | ||||||||
| Income taxes (expenses) | (5,791 | ) | (5,348 | ) | (7,303 | ) | (5,377 | ) | ||||||||
| Net profit / (loss) for the period | (86,878 | ) | (207,419 | ) | (481,447 | ) | (583,194 | ) | ||||||||
| Attributable to owners of the Company | (86,878 | ) | (207,419 | ) | (481,447 | ) | (583,194 | ) | ||||||||
| Basic and diluted earnings / (loss) per share | (1.54 | ) | (3.71 | ) | (8.55 | ) | (10.40 | ) | ||||||||
| Number of shares used for calculation (basic and diluted) | 56,560,368 | 55,941,261 | 56,287,060 | 56,071,793 | ||||||||||||
| Net profit / (loss) for the period | (86,878 | ) | (207,419 | ) | (481,447 | ) | (583,194 | ) | ||||||||
| Other comprehensive income / (loss) | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Exchange differences on translating foreign operations | (1,498 | ) | 2,211 | (2,731 | ) | (327 | ) | |||||||||
| Other comprehensive income / (loss) for the period, net of tax | (1,498 | ) | 2,211 | (2,731 | ) | (327 | ) | |||||||||
| Total comprehensive income / (loss) for the period, net of tax | (88,376 | ) | (205,208 | ) | (484,178 | ) | (583,521 | ) | ||||||||
| Attributable to owners of the Company | (88,376 | ) | (205,208 | ) | (484,178 | ) | (583,521 | ) |
Consolidated Statements of Financial Position
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 4,419 | 4,828 | ||||||
| Property, plant and equipment | 110,634 | 129,095 | ||||||
| Investment in associate | 5,686 | 22,932 | ||||||
| Other receivables | 2,127 | 1,920 | ||||||
| Marketable securities | 7,492 | |||||||
| 122,866 | 166,267 | |||||||
| Current assets | ||||||||
| Inventories | 208,931 | 130,673 | ||||||
| Trade receivables | 35,874 | 11,910 | ||||||
| Income tax receivables | 802 | 883 | ||||||
| Other receivables | 19,097 | 12,833 | ||||||
| Prepayments | 38,578 | 31,717 | ||||||
| Marketable securities | 7,275 | 290,688 | ||||||
| Cash and cash equivalents | 392,164 | 444,767 | ||||||
| 702,721 | 923,471 | |||||||
| Total assets | 825,587 | 1,089,738 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 7,749 | 7,675 | ||||||
| Distributable equity | (153,446 | ) | 255,673 | |||||
| Total equity | (145,697 | ) | 263,348 | |||||
| Non-current liabilities | ||||||||
| Borrowings | 534,246 | 387,556 | ||||||
| Lease liabilities | 84,619 | 95,400 | ||||||
| Derivative liabilities | 143,296 | 157,950 | ||||||
| Contract liabilities | 5,949 | 14,213 | ||||||
| Deferred tax liabilities | 5,830 | |||||||
| 773,940 | 655,119 | |||||||
| Current liabilities | ||||||||
| Borrowings | 11,226 | 11,630 | ||||||
| Lease liabilities | 14,174 | 13,791 | ||||||
| Contract liabilities | 1,184 | |||||||
| Trade payables and accrued expenses | 94,566 | 101,032 | ||||||
| Other liabilities | 41,176 | 31,989 | ||||||
| Income tax payables | 2,299 | 5,490 | ||||||
| Provisions | 32,719 | 7,339 | ||||||
| 197,344 | 171,271 | |||||||
| Total liabilities | 971,284 | 826,390 | ||||||
| Total equity and liabilities | 825,587 | 1,089,738 |