Ascendis Pharma A/S Reports Third Quarter 2021 Financial Results
– SKYTROFA® (lonapegsomatropin-tcgd) approved by the FDA in the
– Completed 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
“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
Company Highlights & Progress
- TransCon hGH
- Now commercially available in the
U.S. for the treatment of pediatric GHD. Sales in theU.S. will be reported under the brand name. - In
Europe , final decision anticipated from theEuropean Commission on our Marketing Authorisation Application, for TransCon hGH in pediatric GHD by the end of 2021 or early 2022. - Enrollment continues in our foresiGHt Trial, a global Phase 3 trial in adult GHD and in the riGHt Trial, a Phase 3 trial in
Japan in pediatric GHD.
- Now commercially available in the
- TransCon PTH
- Completed enrollment in the Phase 3 PaTHway Trial of TransCon PTH in adults with hypoparathyroidism, with topline results expected in Q1 2022.
- 58 subjects continue in the PaTH Forward Trial open-label extension as of
November 7, 2021 , with 84-week topline results expected in Q4 2021. - Enrollment continues in the PaTHway Japan Trial, a single-arm Phase 3 trial of TransCon PTH designed to enroll a minimum of 12 adult Japanese subjects.
- TransCon CNP
- Continued execution in the ongoing Phase 2 ACcomplisH Trial and ACcomplisH China Trial (through
VISEN Pharmaceuticals ) to evaluate the safety and efficacy of TransCon CNP in children ages 2-10 years with achondroplasia.
- Continued execution in the ongoing Phase 2 ACcomplisH Trial and ACcomplisH China Trial (through
- TransCon TLR7/8 Agonist
- Patient enrollment continues in transcendIT-101, a Phase 1/2 study of TransCon TLR7/8 Agonist with or without pembrolizumab in patients with advanced or metastatic solid tumors.
- Presenting new non-clinical data at this week’s SITC 2021 (
Society for Immunotherapy of Cancer’s 36th annual meeting) inWashington D.C.
- TransCon IL-2 β/γ
- Initiated IL βelieγe (“I’ll Believe”) Trial, a Phase 1/2 clinical trial to evaluate TransCon IL-2 β/γ in patients with advanced cancer.
- Ended the third quarter of 2021 with cash, cash equivalents and marketable securities totaling €929.9 million.
- Completed a successful public offering of American Depositary Shares raising net proceeds of approximately
$436 million . - Completed
$25 million share repurchase program of Ascendis’ American Depositary Shares in connection with the Company’s planned share-based incentive program. In total, 154,837 shares were repurchased with a weighted average purchase price of$161.43 . - Virtual R&D update on Ascendis’ pipeline planned for mid-December.
Third Quarter 2021 Financial Results
For the third quarter,
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
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
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
As of
Conference Call Details
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Time | |
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Access Code | 2357838 |
A live webcast of the conference call will be available on the Investors & News section of the
About
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
Ascendis,
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 |
Nine Months Ended |
||||||||||
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 | ||||
(In EUR'000s) | ||||
2021 | 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: +1 (650) 374-6343 tle@ascendispharma.com |
Media Contact: +1 (650) 709-8875 media@ascendispharma.com |
ICR Westwicke +1 (415) 513-1284 patti.bank@westwicke.com ir@ascendispharma.com |
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Source: Ascendis Pharma