Full Press Release Details
Ascendis Pharma A/S Reports Third Quarter 2021 Financial Results
SKYTROFA (lonapegsomatropin-tcgd) approved by the FDA in the U.S. as a
once-weekly treatment for pediatric growth hormone deficiency (GHD); commercially launched in October 2021.
enrollment in Phase 3 PaTHway Trial of TransCon PTH. Topline results expected Q1 2022 and 84-week topline results from Phase 2 PaTH Forward Trial
expected later this quarter.
Company to hold a virtual R&D update on TransCon PTH, TransCon CNP, and TransCon TLR7/8
Agonist in mid-December to review continued pipeline progress.
Strengthened balance
sheet with a successful public offering of American Depositary Shares raising net proceeds of approximately $436 million.
Denmark, November 10, 2021/ Globe Newswire/ Ascendis Pharma A/S (Nasdaq: ASND), today announced financial results for the third quarter ended September 30, 2021.
We are at a defining moment on our way to fulfilling Vision 3x3, our strategy to build a leading global biopharma company. In late August, we received
U.S. FDA approval for TransCon hGH, and in mid-October we launched in the U.S., said Jan Mikkelsen, Ascendis Pharma s President and Chief Executive Officer. We believe this first FDA-approval for a TransCon product validates our technology platform, product innovation algorithm, and product development capabilities. Our robust, diverse pipeline, which today includes five unique clinical
stage product candidates across endocrinology rare diseases and oncology, demonstrates our passion for following the science to address important unmet patient needs.
Company Highlights & Progress
Third Quarter 2021 Financial Results
For the third quarter, Ascendis Pharma reported a net loss of 80.3 million, or 1.47 per share (basic and diluted) compared to a net loss of
121.7 million, or 2.31 per share (basic and diluted) for the same period in 2020.
Revenue for the third quarter was
1.1 million compared to 2.8 million in the same quarter of 2020. The decrease was due to lower sale of clinical supplies to VISEN Pharmaceuticals compared to the same period last year.
Research and development (R&D) costs for the third quarter were 58.8 million compared to 64.1 million during the same period in
2020. The decline in R&D costs in 2021 reflect a one-time reversal of pre-launch inventories, which had been recognized as research and development costs in current
and previous periods. The reversal of pre-launch inventories followed the U.S. FDA approval of SKYTROFA (lonapegsomatropin-tcgd) on August 25, 2021.
Selling, general and administrative expenses for the third quarter were 39.3 million compared to
17.5 million during the same period in 2020. The increase is primarily due to higher personnel-related and IT costs.
Net loss of associate for
the third quarter was 3.9 million compared to a net loss of 3.1 million in the same quarter of 2020. The net loss of associate represents our share of the net result from VISEN Pharmaceuticals.
As of September 30, 2021, Ascendis Pharma had cash, cash equivalents and marketable securities of 929.9 million compared to
641.3 million as of June 30, 2021. As of September 30, 2021, Ascendis Pharma had 56,877,723 ordinary shares outstanding.
Conference Call Details
| Date | Wednesday, November 10, 2021 | |
| Time | 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time | |
| Dial In (U.S.) | 1 844-290-3904 | |
| Dial In (International) | +1 574-990-1036 | |
| Access Code | 2357838 |
A live webcast of the conference call will be available on the Investors & News section of the Ascendis Pharma
website at https://ascendispharma.com. A webcast replay will be available on the site shortly after conclusion of the event and will stay available for 30 days.
About Ascendis Pharma A/S
Ascendis Pharma is applying
its innovative platform technology 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, 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 expected timing of topline results from the Phase 3 Phase 3 PaTHway Trial and
84-week topline results from Phase 2 PaTH Forward Trial, (ii) Ascendis believe that the FDA-approval for a TransCon product validates its technology platform,
product innovation algorithm, and product development capabilities, (iii) the anticipated timing of a decision from the European Commission on Ascendis Marketing Authorisation Application, for TransCon hGH in pediatric GHD,
(iv) Ascendis ability to apply its platform technology to build a leading, fully integrated biopharma company, and (v) 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., the co-pay program, 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, 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; 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. November 2021 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)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | 1,113 | 2,757 | 2,881 | 6,418 | ||||||||||||
| Research and development costs | (58,761 | ) | (64,059 | ) | (230,216 | ) | (185,152 | ) | ||||||||
| Selling, general and administrative expenses | (39,284 | ) | (17,523 | ) | (111,876 | ) | (56,243 | ) | ||||||||
| Operating profit / (loss) | (96,932 | ) | (78,825 | ) | (339,211 | ) | (234,977 | ) | ||||||||
| Share of profit / (loss) of associate | (3,855 | ) | (3,101 | ) | 19,434 | (6,501 | ) | |||||||||
| Finance income | 21,321 | 136 | 44,589 | 1,677 | ||||||||||||
| Finance expenses | (877 | ) | (39,970 | ) | (2,580 | ) | (40,391 | ) | ||||||||
| Profit / (loss) before tax | (80,343 | ) | (121,760 | ) | (277,768 | ) | (280,192 | ) | ||||||||
| Tax on profit / (loss) for the period | (5 | ) | 19 | 253 | 202 | |||||||||||
| Net profit / (loss) for the period | (80,348 | ) | (121,741 | ) | (277,515 | ) | (279,990 | ) | ||||||||
| Attributable to owners of the Company | (80,348 | ) | (121,741 | ) | (277,515 | ) | (279,990 | ) | ||||||||
| Basic and diluted earnings / (loss) per share | (1.47 | ) | (2.31 | ) | (5.13 | ) | (5.64 | ) | ||||||||
| Number of shares used for calculation (basic and diluted) | 54,639,597 | 52,715,204 | 54,085,793 | 49,647,471 | ||||||||||||
| Net profit / (loss) for the period | (80,348 | ) | (121,741 | ) | (277,515 | ) | (279,990 | ) | ||||||||
| Other comprehensive income / (loss) | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Exchange differences on translating foreign operations | 1,016 | (75 | ) | 2,781 | (136 | ) | ||||||||||
| Other comprehensive income / (loss) for the period, net of tax | 1,016 | (75 | ) | 2,781 | (136 | ) | ||||||||||
| Total comprehensive income / (loss) for the period, net of tax | (79,332 | ) | (121,816 | ) | (274,734 | ) | (280,126 | ) | ||||||||
| Attributable to owners of the Company | (79,332 | ) | (121,816 | ) | (274,734 | ) | (280,126 | ) |
Consolidated Statements of Financial Position
| September 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 5,384 | 5,717 | ||||||
| Property, plant and equipment | 126,295 | 108,112 | ||||||
| Investment in associate | 43,639 | 9,176 | ||||||
| Deposits | 1,713 | 1,375 | ||||||
| Marketable securities | 71,614 | 115,280 | ||||||
| 248,645 | 239,660 | |||||||
| Current assets | ||||||||
| Inventories | 55,270 | |||||||
| Trade receivables | 533 | 387 | ||||||
| Other receivables | 20,258 | 6,957 | ||||||
| Prepayments | 22,239 | 13,994 | ||||||
| Marketable securities | 165,347 | 134,278 | ||||||
| Cash and cash equivalents | 692,941 | 584,517 | ||||||
| 956,588 | 740,133 | |||||||
| Total assets | 1,205,233 | 979,793 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 7,638 | 7,217 | ||||||
| Distributable equity | 985,924 | 831,494 | ||||||
| Total equity | 993,562 | 838,711 | ||||||
| Non-current liabilities | ||||||||
| Lease liabilities | 95,553 | 85,116 | ||||||
| Other liabilities | 3,162 | |||||||
| 95,553 | 88,278 | |||||||
| Current liabilities | ||||||||
| Lease liabilities | 6,748 | 6,859 | ||||||
| Contract liabilities | 36 | 363 | ||||||
| Trade payables and accrued expenses | 76,471 | 21,897 | ||||||
| Other payables | 32,362 | 23,384 | ||||||
| Income taxes payable | 501 | 301 | ||||||
| 116,118 | 52,804 | |||||||
| Total liabilities | 211,671 | 141,082 | ||||||
| Total equity and liabilities | 1,205,233 | 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 |