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Ascendis Pharma A/S Reports First Quarter 2022 Financial Results Phase 3 PaTHway Trial top-line results demonstrated potential of TransCon PTH to become the first parathyroid replacement therapy for adults

Key Takeaway: Ascendis Pharma A/S Reports First Quarter 2022 Financial Results Phase 3 PaTHway Trial top-line results demonstrated potential of TransCon PTH to become the first parathyroid replacement therapy for adults with hypoparathyroidism TransCon PTH U.S. FDA regulatory submission on t

Full Press Release Details

Ascendis Pharma A/S Reports First Quarter 2022 Financial Results
Phase 3 PaTHway Trial top-line results demonstrated potential of TransCon PTH to become the first parathyroid replacement therapy for adults with hypoparathyroidism
TransCon PTH U.S. FDA regulatory submission on track for Q3 and EU MAA for Q4 2022
Increasing uptake of SKYTROFA (lonapegsomatropin-tcgd), with
more than 1,200 unique patient prescriptions processed as of April 29, 2022
$575 million convertible notes offering strengthening balance sheet to build a sustainable leading global biopharma company
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, May 11, 2022 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for
the first quarter ended March 31, 2022 and provided a business update.
This continues to be a transformative time for Ascendis as we build on
positive Phase 3 data for our first two endocrinology rare disease programs TransCon hGH and TransCon PTH and our first product approval and launch, said Jan Mikkelsen, Ascendis Pharma s President and Chief Executive
Officer. 2022 marks a key transition point for Ascendis. We have all the elements of success in place a proven technology and algorithm for product innovation, the right capabilities, and a strong balance sheet that allows us to deliver
on all components of our Vision 3x3 as we work to achieve sustainable growth through multiple approaches and long-term profitability.
Highlights & Progress
First Quarter 2022 Financial Results
Total revenue for the first quarter was 6.8 million, an increase of 6.1 million compared to 0.7 million in the same quarter of
2021. Revenues for the first quarter include U.S. commercial SKYTROFA sales, sales of clinical supplies, rendering of services, and recognition of internal profit from the license agreements with VISEN. The increase in revenue was primarily
attributable to the 1.9 million commercial SKYTROFA sales, and 3.9 million higher sales of clinical supply to VISEN compared to the same period last year.
Research and development (R&D) costs for the first quarter were 83.2 million compared to 88.1 million during the same period in
2021. Following FDA approval of SKYTROFA (lonapegsomatropin-tcgd) in August 2021, commercial manufacturing is recognized as inventory while such costs were recognized as R&D costs prior to the FDA approval.
Selling, general, and administrative (SG&A) expenses for the first quarter were 47.4 million compared to 37.2 million during the
same period in 2021. Higher SG&A expenses were primarily due to an increase in commercial and administrative personnel costs as well as an increase in commercial costs.
Net loss of associate was 4.9 million in the first quarter, compared to a net profit of 28.1 million during the same period in 2021.
Net finance income was 7.6 million in the first quarter compared to 33.6 million in the same period in 2021.
For the first quarter of 2022, Ascendis Pharma reported a net loss of 125.5 million, or 2.21 per share (basic and diluted) compared to a net
loss of 62.8 million, or 1.17 per share (basic and diluted) for the same period in 2021.
As of March 31, 2022, Ascendis Pharma had
cash, cash equivalents, and marketable securities totaling 1,065 million compared to 790 million as of December 31, 2021. As of March 31, 2022, Ascendis Pharma had 56,958,391 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 first quarter 2022 financial results. Details include:
Date Wednesday, May 11, 2022
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 6876568
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
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 PaTHway Japan Trial, the ACcomplisH Trial, the transcendIT-101 Trial and the Phase 1/2
IL- elie e Trial, (ii) the timing of patient dosing in the combination dose-escalation arm of the IL- elie e Trial, (iii) Ascendis
expectations regarding the strength of 2022 and its ability to deliver on components of Vision 3x3, (iv) whether Ascendis is able to achieve sustainable growth and long-term profitability, (v) whether Ascendis has the elements of success in
place, including proven technology and algorithm for innovation, the right capabilities, and a strong balance sheet, (vi) Ascendis expectations regarding the timing of its regulatory submissions, applications, protocols, clinical trials
and the results thereof, (vii) Ascendis expectations regarding the regarding the potential for TransCon PTH to become the first parathyroid replacement therapy for adults with hypoparathyroidism, (viii) Ascendis expectations
regarding the ability of its immuno-oncology programs to transform care for cancer patients, (ix) Ascendis expectations regarding its ability to apply its technology platform and algorithm for product innovation to develop highly
differentiated product candidates for unmet medical needs, (x) Ascendis ability to apply its platform technology to build a leading, fully integrated biopharma company, and (xi) 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 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.
Pharma, the Ascendis Pharma logo, the company logo, TransCon, and SKYTROFA are trademarks owned by the Ascendis Pharma Group. May 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 March 31,
2022 2021
Revenue 6,828 746
Cost of sales 4,246
Gross profit / (loss) 2,582 746
Research and development costs 83,193 88,149
Selling, general and administrative expenses 47,418 37,247
Operating profit / (loss) (128,029 ) (124,650 )
Share of profit / (loss) of associate (4,873 ) 28,106
Finance income 13,044 34,430
Finance expenses 5,399 869
Profit / (loss) before tax (125,257 ) (62,983 )
Tax on profit / (loss) for the period (241 ) 191
Net profit / (loss) for the period (125,498 ) (62,792 )
Attributable to owners of the Company (125,498 ) (62,792 )
Basic and diluted earnings / (loss) per share (2.21 ) (1.17 )
Weighted average number of shares used for calculation (basic and diluted) 56,720,063 53,759,952
Net profit / (loss) for the period (125,498 ) (62,792 )
Other comprehensive income / (loss)
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translating foreign operations 425 1,842
Other comprehensive income / (loss) for the period, net of tax 425 1,842
Total comprehensive income / (loss) for the period, net of tax (125,073 ) (60,950 )
Attributable to owners of the Company (125,073 ) (60,950 )
Consolidated Statements of Financial Position
March 31, 2022 December 31, 2021
Assets
Non-current assets
Intangible assets 5,161 5,272
Property, plant and equipment 127,678 126,049
Investment in associate 35,023 38,345
Other receivables 1,822 1,808
Marketable securities 86,487 107,561
256,171 279,035
Current assets
Inventories 92,436 75,405
Trade receivables 5,808 2,200
Income tax receivable 1,072 893
Other receivables 15,071 20,093
Prepayments 27,994 25,231
Marketable securities 223,055 235,797
Cash and cash equivalents 755,643 446,267
1,121,079 805,886
Total assets 1,377,250 1,084,921
Equity and liabilities
Equity
Share capital 7,649 7,646
Distributable equity 665,167 875,989
Total equity 672,816 883,635
Non-current liabilities
Borrowings 464,736 97,966
Derivative liabilities 141,379
Contract liabilities 2,964 2,964
609,079 100,930
Current liabilities
Borrowings 8,926 6,995
Contract liabilities 265 2,601
Trade payables and accrued expenses 70,683 59,417
Other liabilities 12,536 29,952
Income taxes payable 499 198
Provisions 2,446 1,193
95,355 100,356
Total liabilities 704,434 201,286
Total equity and liabilities 1,377,250 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
Patti Bank
ICR Westwicke
+1 (415) 513-1284
patti.bank@westwicke.com
ir@ascendispharma.com
Last updated: Apr 29, 2022