Full Press Release Details
Ascendis Pharma A/S Reports Second Quarter 2022 Financial Results
U.S. regulatory submission for TransCon PTH, designed to be the first parathyroid hormone replacement therapy, on track for Q3 2022;
EU submission planned for Q4 2022
SKYTROFA revenue continued to double quarter-to-quarter, reaching 4.4 million in the second quarter
With anticipated growth in U.S. revenues and approximately 1 billion of cash, cash
equivalents, and marketable securities on hand, Ascendis is positioned to fulfill Vision 3x3 and become cash flow positive
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, August 10, 2022 (GLOBE NEWSWIRE) Ascendis Pharma A/S
(Nasdaq: ASND) today announced financial results for the second quarter ended June 30, 2022, and provided a business update.
launch of TransCon PTH in the U.S. next year, combined with our progress towards making SKYTROFA the leading product in a growing growth hormone market, moves us closer to fulfilling our Vision 3x3 and becoming a sustainable, profitable, leading
biopharma company, said Jan Mikkelsen, Ascendis Pharma s President and Chief Executive Officer.
Company Highlights & Progress
| U.S. SKYTROFA Launch Metrics | Q4-2021 | Q1-2022 | Q2-2022 | |||||||||
| SKYTROFA revenue (millions) | 0.9 | 1.9 | 4.4 | |||||||||
| Cumulative number of new patient SKYTROFA prescriptions | 369 | 976 | 1,707 | |||||||||
| Total number of prescribers to date | 139 | 349 | 505 | |||||||||
| Percent of prescribers to date who have written prescriptions for more than one patient | 42 | % | 46 | % | 53 | % | ||||||
| % of U.S. lives covered* | 34 | % | 45 | % | 57 | % |
Second Quarter 2022 Financial Results
Total revenue for the second quarter was 6.2 million compared to 1.0 million in the same quarter of 2021. Revenue included U.S. revenue
from SKYTROFA, as well as license, clinical supply and services provided to third parties, primarily VISEN Pharmaceuticals. The increase in revenue compared to the same period the prior year was primarily attributable to the 4.4 million
commercial revenue from SKYTROFA (lonapegsomatropin-tcgd) in the second quarter following U.S. commercial launch in October 2021.
development (R&D) costs for the second quarter were 90.4 million compared to 83.3 million during the same period in 2021, reflecting primarily higher employee costs resulting from an increase in the number of R&D
Selling, general, and administrative (SG&A) expenses for the second quarter were 56.6 million compared to
35.3 million during the same period in 2021. Higher SG&A expenses were primarily due to an increase in commercial and administrative personnel following the launch of SKYTROFA.
Our share of net loss of associate was 1.2 million in the second quarter, compared to a net loss of 4.8 million during the same period
Net finance income was 61.7 million in the second quarter compared to a net finance expense of 12.0 million in the same
For the second quarter of 2022, Ascendis Pharma reported a net loss of 81.3 million, or 1.46 per share (basic and
diluted) compared to a net loss of 134.4 million, or 2.50 per share (basic and diluted) for the same period in 2021.
2022, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling 994.9 million compared to 789.6 million as of December 31, 2021. As of June 30, 2022, Ascendis Pharma had 56,965,058 ordinary shares
Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its second quarter 2022 financial results.
Those who would like to listen to the live webcast can access it through the following link. To access the live teleconference, register online
here. Participants are encouraged to register at least 15 minutes prior to the call.
A replay of the webcast will be available on the
Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com shortly after conclusion of the event for 30 days.
About Ascendis Pharma A/S
Ascendis Pharma is 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 the ACcomplisH Trial, the transcendIT-101 Trial and the Phase 1/2 IL- elie e Trial,
(ii) the timing of completion of patient enrollment in the foresiGHt Trial and the riGHt Trial, (iii) Ascendis expectations regarding the strength of 2022, the growth of U.S. revenues and its ability to fulfill Vision 3x3 and become
cash flow positive, (iv) whether Ascendis is able to become a sustainable, profitable, leading biopharma company, (v) the expected launch of TransCon PTH in the U.S. in 2023, (vi) the expected launch of TransCon hGH in Europe in 2023,
(vii) Ascendis expectations regarding the timing of its regulatory submissions, applications, protocols, clinical trials and the results thereof, (viii) Ascendis expectations regarding the potential for TransCon PTH to become the
first parathyroid replacement therapy, (ix) Ascendis ability to make SKYTROFA the leading product in the growth hormone market, (x) Ascendis ability to apply its platform technology to build a leading, fully integrated
biopharma company, (xi) Ascendis use of its TransCon technologies to create new and potentially best-in-class therapies and (xii) Ascendis intent
to nominate Bill Fairey and Siham Imani to its Board of Directors and the timing of the Extraordinary General Meeting. 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 and the SKYTROFA Auto-Injector for commercial sales in the U.S. and other study drug for 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 TransCon hGH 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; 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; 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 and the ongoing conflict in the region surrounding Ukraine and Russia. 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 2, 2022 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. August 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)
| Three Months ended June 30, | Six Months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | 6,160 | 1,022 | 12,988 | 1,767 | ||||||||||||
| Cost of sales | 1,086 | 5,332 | ||||||||||||||
| Gross profit / (loss) | 5,074 | 1,022 | 7,656 | 1,767 | ||||||||||||
| Research and development costs | 90,383 | 83,306 | 173,576 | 171,455 | ||||||||||||
| Selling, general and administrative expenses | 56,584 | 35,345 | 104,002 | 72,591 | ||||||||||||
| Operating profit / (loss) | (141,893 | ) | (117,629 | ) | (269,922 | ) | (242,279 | ) | ||||||||
| Share of profit / (loss) of associate | (1,166 | ) | (4,817 | ) | (6,039 | ) | 23,289 | |||||||||
| Finance income | 71,127 | 145 | 84,171 | 23,268 | ||||||||||||
| Finance expenses | 9,434 | 12,141 | 14,833 | 1,703 | ||||||||||||
| Profit / (loss) before tax | (81,366 | ) | (134,442 | ) | (206,623 | ) | (197,425 | ) | ||||||||
| Tax on profit / (loss) for the period | 47 | 68 | (195 | ) | 259 | |||||||||||
| Net profit / (loss) for the period | (81,319 | ) | (134,374 | ) | (206,818 | ) | (197,166 | ) | ||||||||
| Attributable to owners of the Company | (81,319 | ) | (134,374 | ) | (206,818 | ) | (197,166 | ) | ||||||||
| Basic and diluted earnings / (loss) per share | (1.46 | ) | (2.50 | ) | (3.68 | ) | (3.66 | ) | ||||||||
| Number of shares used for calculation (basic and diluted) | 55,805,486 | 53,848,166 | 56,260,248 | 53,804,300 | ||||||||||||
| Net profit / (loss) for the period | (81,319 | ) | (134,374 | ) | (206,818 | ) | (197,166 | ) | ||||||||
| Other comprehensive income / (loss) | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Exchange differences on translating foreign operations | (757 | ) | 77 | (332 | ) | 1,765 | ||||||||||
| Other comprehensive income / (loss) for the period, net of tax | (757 | ) | 77 | (332 | ) | 1,765 | ||||||||||
| Total comprehensive income / (loss) for the period, net of tax | (82,076 | ) | (134,297 | ) | (207,150 | ) | (195,401 | ) | ||||||||
| Attributable to owners of the Company | (82,076 | ) | (134,297 | ) | (207,150 | ) | (195,401 | ) |
Consolidated Statements of Financial Position
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 5,050 | 5,272 | ||||||
| Property, plant and equipment | 133,224 | 126,049 | ||||||
| Investment in associate | 34,905 | 38,345 | ||||||
| Other receivables | 1,836 | 1,808 | ||||||
| Marketable securities | 39,721 | 107,561 | ||||||
| 214,736 | 279,035 | |||||||
| Current assets | ||||||||
| Inventories | 101,322 | 75,405 | ||||||
| Trade receivables | 4,369 | 2,200 | ||||||
| Income tax receivable | 1,128 | 893 | ||||||
| Other receivables | 15,055 | 20,093 | ||||||
| Prepayments | 35,067 | 25,231 | ||||||
| Marketable securities | 282,767 | 235,797 | ||||||
| Cash and cash equivalents | 672,387 | 446,267 | ||||||
| 1,112,095 | 805,886 | |||||||
| Total assets | 1,326,831 | 1,084,921 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 7,649 | 7,646 | ||||||
| Distributable equity | 600,193 | 875,989 | ||||||
| Total equity | 607,842 | 883,635 | ||||||
| Non-current liabilities | ||||||||
| Borrowings | 498,130 | 97,966 | ||||||
| Derivative liabilities | 102,031 | |||||||
| Contract liabilities | 3,700 | 2,964 | ||||||
| 603,861 | 100,930 | |||||||
| Current liabilities | ||||||||
| Borrowings | 14,079 | 6,995 | ||||||
| Contract liabilities | 2,601 | |||||||
| Trade payables and accrued expenses | 74,984 | 59,417 | ||||||
| Other liabilities | 20,957 | 29,952 | ||||||
| Income taxes payable | 90 | 198 | ||||||
| Provisions | 5,018 | 1,193 | ||||||
| 115,128 | 100,356 | |||||||
| Total liabilities | 718,989 | 201,286 | ||||||
| Total equity and liabilities | 1,326,831 | 1,084,921 |
| 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 |