Full Press Release Details
Ascendis Pharma A/S Reports Second Quarter 2021 Financial Results
Announced U.S. Food and Drug Administration Approval of SKYTROFA
(lonapegsomatropin-tcgd), the First Once-weekly Treatment for Pediatric Growth Hormone Deficiency
target enrollment in Phase 3 PaTHway Trial for TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism (HP); top-line results expected in Q1 2022
Initiated combination therapy arm in transcendIT-101; TransCon TLR7/8 Agonist used in
combination with a check point inhibitor (CPI)
Conference call today at 4:30 p.m. Eastern Time
COPENHAGEN, Denmark, August 25, 2021/ Globe Newswire/ Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical
company that utilizes its innovative TransCon technologies to potentially create new treatments that make a meaningful difference in patients lives, today announced financial results
for the second quarter ended June 30, 2021.
We are actively preparing for the U.S. commercial launch of SKYTROFA for the treatment of children
with GHD, which is now the first FDA-approved once-weekly treatment for pediatric GHD. SKTROFA is also the first FDA-approved product utilizing our innovative TransCon
technology. Our pivotal heiGHt Trial demonstrated that once-weekly TransCon hGH increased annualized height velocity in treatment-na ve subjects at 52 weeks compared to a daily growth hormone with
comparable safety and tolerability, said Jan Mikkelsen, Ascendis Pharma s President and Chief Executive Officer. We see this approval as the first step in creating a market leading product and building a fully integrated global
biopharmaceutical company guided by our values of patients, science, and passion.
Company Highlights & Progress
Second Quarter 2021 Financial Results
For the second quarter, Ascendis Pharma reported a net loss of 134.4 million, or 2.50 per share (basic and diluted) compared to a net loss of
94.9 million, or 1.97 per share (basic and diluted) for the same period in 2020.
Revenue for the second quarter was
1.0 million compared to 1.4 million in the same quarter of 2020. The decrease was due to a lower amount of license revenue being recognized, partly offset by higher sale of clinical supplies and services to VISEN and
recognition of revenue from services rendered to another collaboration partner.
Research and development (R&D) costs for the second quarter were
83.3 million compared to 63.6 million during the same period in 2020. Higher R&D costs in 2021 reflect an increase in external development costs of the company s product candidates and an increase in personnel-related
Selling, general and administrative expenses for the second quarter were 35.3 million compared to 20.8 million during the
same period in 2020. The increase is primarily due to higher personnel-related costs and an increase in IT costs.
Net loss of associate for the second quarter was 4.8 million compared to a net loss of
1.9 million in the same quarter of 2020. The net loss of associate represents our share of the net result from VISEN.
2021, Ascendis Pharma had cash, cash equivalents and marketable securities of 641.3 million compared to 771.1 million as of March 31, 2021. As of June 30, 2021, Ascendis Pharma had 53,900,990 ordinary shares
Conference Call Details
| Date | Wednesday, August 25, 2021 | |
| Time | 4:30 p.m. ET/1:30 p.m. Pacific Time | |
| Dial In (U.S.) | 844-290-3904 | |
| Dial In (International) | 574-990-1036 | |
| Access Code | 8553236 |
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at
www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.
Ascendis Pharma currently has three product candidates in clinical development in rare endocrine diseases and one oncology
product candidate in clinical development:
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 utilizes its TransCon technologies to create new and potentially
best-in-class therapies.
Ascendis Pharma currently has a pipeline of
multiple independent endocrinology rare disease and oncology product candidates in development. The company continues to expand into additional therapeutic areas to address unmet patient needs.
Ascendis is headquartered in Copenhagen, Denmark, with additional facilities in Heidelberg and Berlin, Germany, in Palo Alto and Redwood City, California, and
in Princeton, New Jersey.
Please visit www.ascendispharma.com (for global information) or www.ascendispharma.us (for U.S.
Forward-Looking Statements
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) Ascendis expectations regarding the U.S. commercial launch of SKYTROFA,
(ii) Ascendis planned IND submission for TransCon IL-2 /y in the third quarter of 2021, (iii) Ascendis expectations regarding the European Commission s decision on its Marketing
Authorisation Application in the fourth quarter of 2021, (iv) Ascendis expectations regarding the announcement of top line results from the OLE portion of the PaTH Forward Trial in the fourth quarter of 2021, (v) Ascendis expectations
regarding the announcement of top line results from the PaTHway Trial in the first quarter of 2022, (vi) Ascendis ability to apply its platform technology to build a leading, fully integrated biopharma company, (vii) Ascendis
product pipeline and expansion into additional therapeutic areas and (viii) Ascendis expectations regarding its ability to utilize 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 to supply SKYTROFA, the
SKYTROFA Auto-Injector and other study drug for commercial sales and clinical studies; unforeseen safety or efficacy results in its oncology programs, SKYTROFA, TransCon PTH and TransCon CNP
or other development programs; unforeseen expenses related to commercialization of SKYTROFA and the further development of SKYTROFA, expenses related to the development and potential commercialization of its oncology programs, 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, SKYTROFA, 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 in-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.
SKYTROFA, Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks
owned by the Ascendis Pharma Group. August 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | 1,022 | 1,436 | 1,767 | 3,661 | ||||||||||||
| Research and development costs | (83,306 | ) | (63,578 | ) | (171,455 | ) | (121,093 | ) | ||||||||
| Selling, general and administrative expenses | (35,345 | ) | (20,805 | ) | (72,591 | ) | (38,720 | ) | ||||||||
| Operating profit / (loss) | (117,629 | ) | (82,947 | ) | (242,279 | ) | (156,152 | ) | ||||||||
| Share of profit / (loss) of associate | (4,817 | ) | (1,885 | ) | 23,289 | (3,400 | ) | |||||||||
| Finance income | 145 | 86 | 23,268 | 1,996 | ||||||||||||
| Finance expenses | (12,141 | ) | (10,292 | ) | (1,703 | ) | (876 | ) | ||||||||
| Profit / (loss) before tax | (134,442 | ) | (95,038 | ) | (197,425 | ) | (158,432 | ) | ||||||||
| Tax on profit / (loss) for the period | 68 | 106 | 259 | 183 | ||||||||||||
| Net profit / (loss) for the period | (134,374 | ) | (94,932 | ) | (197,166 | ) | (158,249 | ) | ||||||||
| Attributable to owners of the Company | (134,374 | ) | (94,932 | ) | (197,166 | ) | (158,249 | ) | ||||||||
| Basic and diluted earnings / (loss) per share | (2.50 | ) | (1.97 | ) | (3.66 | ) | (3.29 | ) | ||||||||
| Number of shares used for calculation (basic and diluted) | 53,848,166 | 48,207,661 | 53,804,300 | 48,096,749 | ||||||||||||
| Net profit / (loss) for the period | (134,374 | ) | (94,932 | ) | (197,166 | ) | (158,249 | ) | ||||||||
| Other comprehensive income / (loss) | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Exchange differences on translating foreign operations | 77 | (147 | ) | 1,765 | (61 | ) | ||||||||||
| Other comprehensive income / (loss) for the period, net of tax | 77 | (147 | ) | 1,765 | (61 | ) | ||||||||||
| Total comprehensive income / (loss) for the period, net of tax | (134,297 | ) | (95,079 | ) | (195,401 | ) | (158,310 | ) | ||||||||
| Attributable to owners of the Company | (134,297 | ) | (95,079 | ) | (195,401 | ) | (158,310 | ) |
Consolidated Statements of Financial Position
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 5,495 | 5,717 | ||||||
| Property, plant and equipment | 123,924 | 108,112 | ||||||
| Investment in associate | 45,783 | 9,176 | ||||||
| Deposits | 1,702 | 1,375 | ||||||
| Marketable securities | 90,693 | 115,280 | ||||||
| 267,597 | 239,660 | |||||||
| Current assets | ||||||||
| Trade receivables | 394 | 387 | ||||||
| Other receivables | 11,398 | 6,957 | ||||||
| Prepayments | 21,826 | 13,994 | ||||||
| Marketable securities | 166,094 | 134,278 | ||||||
| Cash and cash equivalents | 384,539 | 584,517 | ||||||
| 584,251 | 740,133 | |||||||
| Total assets | 851,848 | 979,793 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 7,237 | 7,217 | ||||||
| Distributable equity | 680,250 | 831,494 | ||||||
| Total equity | 687,487 | 838,711 | ||||||
| Non-current liabilities | ||||||||
| Lease liabilities | 94,059 | 85,116 | ||||||
| Other liabilities | 3,162 | |||||||
| 94,059 | 88,278 | |||||||
| Current liabilities | ||||||||
| Lease liabilities | 6,950 | 6,859 | ||||||
| Contract liabilities | 145 | 363 | ||||||
| Trade payables and accrued expenses | 44,207 | 21,897 | ||||||
| Other payables | 18,623 | 23,384 | ||||||
| Income taxes payable | 377 | 301 | ||||||
| 70,302 | 52,804 | |||||||
| Total liabilities | 164,361 | 141,082 | ||||||
| Total equity and liabilities | 851,848 | 979,793 |
| Investor contacts: | Media contact: | |
| Tim Lee | Melinda Baker | |
| Ascendis Pharma | Ascendis Pharma | |
| (650) 374-6343 | (650) 709-8875 | |
| tle@ascendispharma.com | media@ascendispharma.com | |
| Patti Bank | ||
| Westwicke Partners | ||
| (415) 513-1284 | ||
| patti.bank@westwicke.com | ||
| ir@ascendispharma.com |