Full Press Release Details
Ascendis Pharma A/S Reports Full Year 2021 Financial Results and
Provides a Business Update
Top-line results from PaTHway, a Phase 3 randomized study evaluating the safety, tolerability,
and efficacy of TransCon PTH in adult hypoparathyroidism (HP) patients on track for this
(lonapegsomatropin-tcgd), the only FDA-approved once-weekly
somatropin, continues to grow in the U.S.
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, March 2, 2022 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for
the full year ended December 31, 2021 and provided a business update.
2021 was an extraordinary year for Ascendis, and we expect that 2022
will be even stronger. The regulatory approvals of TransCon hGH in the U.S. and Europe were key milestones in achieving our Vision 3x3, said Jan Mikkelsen, Ascendis Pharma s President and Chief Executive Officer.
By progressing towards our Vision 3x3, we believe we are moving towards becoming a viable, sustainable, and profitable biopharmaceutical company. We
estimate that our first therapeutic area of endocrinology rare disease alone represents a combined US$10 billion global market potential. On top of that, we have a highly differentiated oncology pipeline, and we plan to add a third therapeutic
area, continued Mr. Mikkelsen.
Corporate 2021 Highlights & Anticipated 2022 Milestones
Full Year 2021 Financial Results
Total revenue for 2021 was 7.8 million compared to 7.0 million in 2020. Revenues for 2021 include U.S. SKYTROFA sales, and license,
clinical supply and services provided to third parties, primarily VISEN Pharmaceuticals.
Research and development (R&D) costs for 2021 were
295.9 million compared to 260.9 million in 2020. Higher R&D costs in 2021 reflect continued advancement of development programs and an increase in personnel-related costs to support them.
Selling, general, and administrative (SG&A) expenses for 2021 were 160.2 million compared to 76.7 million in 2020. Higher SG&A
expenses were primarily due to an increase in commercial and administrative personnel as well as an increase in commercial and IT costs.
associate was 12.0 million for 2021, compared to a net loss of 9.5 million for 2020. For 2021, the net profit of associate included a non-cash gain of 42.3 million as a result
of a financing round in VISEN.
Net finance income was 55.8 million in 2021 compared to a net expense of 79.0 million in 2020.
For the full year 2021, Ascendis Pharma reported a net loss of 383.6 million, or 7.00 per share (basic and diluted) compared to a net loss of
419.0 million, or 8.28 per share (basic and diluted) for the same period in 2020.
As of December 31, 2021, Ascendis Pharma had cash,
cash equivalents, and marketable securities totaling 789.6 million compared to 834.1 million as of December 31, 2020. As of December 31, 2021, Ascendis Pharma had 56,937,682 ordinary shares outstanding.
Conference Call and Webcast Information
will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its full year 2021 financial results. Details include:
| Time | 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time | |
| Dial In (U.S.) | 844-290-3904 | |
| Dial In (International) | 574-990-1036 | |
| Access Code | 2009938 |
A live webcast of the conference call will be accessible from the Investors and News section of the Ascendis Pharma website at
www.ascendispharma.com. A replay of the webcast will be available on this website shortly after conclusion of the event for 30 days.
About Ascendis Pharma A/S
applying its innovative platform technology to build a leading, fully integrated, global biopharmaceutical company focused on making a meaningful difference in patients lives. Guided by its core values of patients, science and passion, the
company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark, and has additional
facilities in Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit www.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 top-line results from PaTHway, (ii) the demand for SKYTROFA, (iii) Ascendis expectations regarding the strength of 2022, (iv) whether Ascendis is moving towards becoming a viable,
sustainable, and profitable biopharmaceutical company, (v) the estimated market potential of Ascendis first therapeutic area of endocrinology rare disease, (vi) Ascendis plan to add a third therapeutic area,
(vii) Ascendis plan to submit a protocol to FDA to evaluate TransCon hGH for Turner Syndrome in the second quarter of 2022, (viii) Ascendis expectations to evaluate higher doses of TransCon hGH and daily growth hormone for Turner
Syndrome compared to those doses for pediatric or adult GHD, (ix) Ascendis expectations regarding the timing of its applications, protocols, clinical trials and the results thereof, (x) Ascendis ability to apply its platform
technology to build a leading, fully integrated biopharma company, and (xii) 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 and distributors to supply TransCon hGH, the
SKYTROFA Auto-Injector and other study drug for commercial sales in the U.S. and clinical studies; unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH
and TransCon CNP or other development programs; unforeseen expenses related to commercialization of lonapegsomatropin-tcgd in the U.S. and the further development of TransCon hGH,
expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen selling,
general and administrative expenses, other research and development expenses and Ascendis business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related
to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; uncertainty regarding market-size estimates, Ascendis profitability, and consumer demand for
Ascendis current or future products and product candidates; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis ability to obtain additional funding, if needed, to support its business
activities and the effects on its business from the worldwide COVID-19 pandemic. 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
March 10, 2021 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, and SKYTROFA are trademarks owned by the Ascendis Pharma Group.
March 2022 Ascendis Pharma A/S.
FINANCIAL TABLES FOLLOW
Consolidated Statements of Profit
or Loss and Comprehensive Income / (loss)
(In EUR 000s, except share and per share data)
| Year Ended December 31, | ||||||||||||
| 2021 | 2020 | |||||||||||
| Revenue | 7,778 | 6,953 | ||||||||||
| Cost of sales | 3,523 | - | ||||||||||
| Gross profit | 4,255 | 6,953 | ||||||||||
| Research and development costs | 295,867 | 260,904 | ||||||||||
| Selling, general and administrative expenses | 160,180 | 76,669 | ||||||||||
| Operating profit / (loss) | (451,792 | ) | (330,620 | ) | ||||||||
| Share of profit / (loss) of associate | 12,041 | (9,524 | ) | |||||||||
| Finance income | 59,718 | 1,812 | ||||||||||
| Finance expenses | 3,911 | 80,842 | ||||||||||
| Profit / (loss) before tax | (383,944 | ) | (419,174 | ) | ||||||||
| Tax on profit / (loss) for the year | 367 | 219 | ||||||||||
| Net profit / (loss) for the year | (383,577 | ) | (418,955 | ) | ||||||||
| Attributable to owners of the Company | (383,577 | ) | (418,955 | ) | ||||||||
| Basic and diluted earnings / (loss) per share | (7.00 | ) | (8.28 | ) | ||||||||
| Weighted average number of shares used for calculation (basic and diluted) | 54,771,763 | 50,616,528 | ||||||||||
| Net profit / (loss) for the period | (383,577 | ) | (418,955 | ) | ||||||||
| Other comprehensive income / (loss) | ||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||
| Exchange differences on translating foreign operations | 3,855 | (42 | ) | |||||||||
| Other comprehensive income / (loss) for the year, net of tax | 3,855 | (42 | ) | |||||||||
| Total comprehensive income / (loss) for the year, net of tax | (379,722 | ) | (418,997 | ) | ||||||||
| Attributable to owners of the Company | (379,722 | ) | (418,997 | ) |
Consolidated Statements of Financial Position
| December 31, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 5,272 | 5,717 | ||||||
| Property, plant and equipment | 126,049 | 108,112 | ||||||
| Investment in associate | 38,345 | 9,176 | ||||||
| Other receivables | 1,808 | 1,375 | ||||||
| Marketable securities | 107,561 | 115,280 | ||||||
| 279,035 | 239,660 | |||||||
| Current assets | ||||||||
| Inventories | 75,405 | - | ||||||
| Trade receivables | 2,200 | 387 | ||||||
| Income tax receivable | 893 | - | ||||||
| Other receivables | 20,093 | 6,957 | ||||||
| Prepayments | 25,231 | 13,994 | ||||||
| Marketable securities | 235,797 | 134,278 | ||||||
| Cash and cash equivalents | 446,267 | 584,517 | ||||||
| 805,886 | 740,133 | |||||||
| Total assets | 1,084,921 | 979,793 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 7,646 | 7,217 | ||||||
| Distributable equity | 875,989 | 831,494 | ||||||
| Total equity | 883,635 | 838,711 | ||||||
| Non-current liabilities | ||||||||
| Lease liabilities | 97,966 | 85,116 | ||||||
| Contract liabilities | 2,964 | - | ||||||
| Other liabilities | - | 3,162 | ||||||
| 100,930 | 88,278 | |||||||
| Current liabilities | ||||||||
| Lease liabilities | 6,995 | 6,859 | ||||||
| Contract liabilities | 2,601 | 363 | ||||||
| Trade payables and accrued expenses | 59,417 | 21,897 | ||||||
| Other liabilities | 29,952 | 23,384 | ||||||
| Income tax payables | 198 | 301 | ||||||
| Provisions | 1,193 | - | ||||||
| 100,356 | 52,804 | |||||||
| Total liabilities | 201,286 | 141,082 | ||||||
| Total equity and liabilities | 1,084,921 | 979,793 |
| 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 | |
| Patti Bank | ||
| ICR Westwicke | ||
| +1 (415) 513-1284 | ||
| patti.bank@westwicke.com | ||
| ir@ascendispharma.com |