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Ascendis Pharma Reports Third Quarter 2022 Financial Results SKYTROFA U.S. revenue more than doubled quarter-to-quarter again, reaching 12.3 million in the third quarter FDA accepted for Priority Review TransCon PTH NDA

Key Takeaway: Ascendis Pharma Reports Third Quarter 2022 Financial Results SKYTROFA U.S. revenue more than doubled quarter-to-quarter again, reaching 12.3 million in the third quarter FDA accepted for Priority Review TransCon PTH NDA in adult patients with hypoparathyroidism; target action

Full Press Release Details

Ascendis Pharma Reports Third Quarter 2022 Financial Results
SKYTROFA U.S. revenue more than doubled quarter-to-quarter again, reaching 12.3 million in the third quarter
FDA accepted for Priority Review TransCon PTH NDA in adult
patients with hypoparathyroidism; target action PDUFA date is April 30, 2023
Announced selection of Phase
2 recommended dose of TransCon TLR7/8 Agonist; first-in-human data accepted for oral presentation at SITC 2022
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, November 2, 2022 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results
for the third quarter ended September 30, 2022 and provided a business update.
With our improved commercial execution and emphasis on
SKYTROFA s unique patient-focused product strengths, I believe we are advancing our goal to build SKYTROFA into the leading brand and expand the pediatric growth hormone market, said Jan Mikkelsen, Ascendis Pharma s President and
Chief Executive Officer. With our expanding global commercial activities, potential U.S. approval of TransCon PTH in April 2023, and new data expected in achondroplasia and oncology, I am confident in our ability to deliver multiple high-value
products to drive long-term sustainable growth.
Third Quarter 2022 Financial Results
Total revenue for the third quarter was 15.3 million compared to 1.1 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 last year was primarily attributable to the 12.3 million
commercial revenue from SKYTROFA.
Research and development (R&D) costs for the third quarter were 97.4 million compared to
58.8 million during the same period in 2021. Lower R&D costs in the third quarter of 2021 reflect a one-time 53.7 million reversal of
pre-launch inventories, which had previously been recognized as research and development costs. The third quarter 2022 R&D costs also reflect the manufacturing of
pre-launch inventories for TransCon PTH and an increase in employee and other costs attributable to organizational growth.
Selling, general, and administrative (SG&A) expenses for the third quarter were 60.7 million
compared to 39.3 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 in the U.S. and preparation for future product
Our share of net loss of associate was 3.7 million in the third quarter, compared to a net loss of 3.9 million during the
same period in 2021.
Net finance loss was 20.9 million in the third quarter compared to a net finance income of 20.4 million in the
same period in 2021.
For the third quarter of 2022, Ascendis Pharma reported a net loss of 169.0 million, or 3.03 per share (basic and
diluted) compared to a net loss of 80.3 million, or 1.47 per share (basic and diluted) for the same period in 2021.
September 30, 2022, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling 935.1 million compared to 789.6 million as of December 31, 2021. As of September 30, 2022, Ascendis Pharma had
57,027,240 ordinary shares outstanding.
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 third quarter 2022 financial results.
Those who would like to listen to the live webcast can access it through the following link here. 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 TransCon platform to build a leading, fully integrated, global 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 timing and announcement of top-line results from the PaTHway Japan Trial, 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, ApproaCH
Trial and the IL- elie e Trial, (iii) Ascendis ability to deliver multiple high-value products and drive long-term sustainable growth, (iv) the expected launch of TransCon PTH in the
U.S. in 2023, (v) the expected launch of TransCon hGH in Europe in 2023, (vi) Ascendis expectations regarding the timing of its regulatory approvals, submissions, applications, protocols, clinical trials and the results thereof,
(vii) Ascendis ability to make SKYTROFA the leading brand and expand the growth hormone market, (viii)
Ascendis ability to apply its TransCon platform to build a leading, fully integrated global biopharma company, and (ix) 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 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;
the impact of international economic, political, legal, compliance, social and business factors, including inflation, 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. November 2022 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 September 30, Nine Months ended September 30,
2022 2021 2022 2021
Revenue 15,290 1,113 28,278 2,881
Cost of sales 1,693 7,025
Gross profit / (loss) 13,597 1,113 21,253 2,881
Research and development costs 97,431 58,761 271,006 230,216
Selling, general and administrative expenses 60,671 39,284 164,675 111,876
Operating profit / (loss) (144,505 ) (96,932 ) (414,428 ) (339,211 )
Share of profit / (loss) of associate (3,696 ) (3,855 ) (9,736 ) 19,434
Finance income 20,326 21,321 73,797 44,589
Finance expenses 41,247 877 25,381 2,580
Profit / (loss) before tax (169,122 ) (80,343 ) (375,748 ) (277,768 )
Tax on profit / (loss) for the period 167 (5 ) (28 ) 253
Net profit / (loss) for the period (168,955 ) (80,348 ) (375,776 ) (277,515 )
Attributable to owners of the Company (168,955 ) (80,348 ) (375,776 ) (277,515 )
Basic and diluted earnings / (loss) per share (3.03 ) (1.47 ) (6.70 ) (5.13 )
Number of shares used for calculation (basic and diluted) 55,831,561 54,639,597 56,115,782 54,085,793
Net profit / (loss) for the period (168,955 ) (80,348 ) (375,776 ) (277,515 )
Other comprehensive income / (loss)
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translating foreign operations (2,207 ) 1,016 (2,538 ) 2,781
Other comprehensive income / (loss) for the period, net of tax (2,207 ) 1,016 (2,538 ) 2,781
Total comprehensive income / (loss) for the period, net of tax (171,162 ) (79,332 ) (378,314 ) (274,734 )
Attributable to owners of the Company (171,162 ) (79,332 ) (378,314 ) (274,734 )
Consolidated Statements of Financial Position
September 30, December 31,
2022 2021
Assets
Non-current assets
Intangible assets 4,939 5,272
Property, plant and equipment 139,345 126,049
Investment in associate 32,001 38,345
Other receivables 1,895 1,808
Marketable securities 15,338 107,561
193,518 279,035
Current assets
Inventories 103,975 75,405
Trade receivables 6,655 2,200
Income tax receivable 1,630 893
Other receivables 13,264 20,093
Prepayments 34,568 25,231
Marketable securities 311,480 235,797
Cash and cash equivalents 608,330 446,267
1,079,902 805,886
Total assets 1,273,420 1,084,921
Equity and liabilities
Equity
Share capital 7,658 7,646
Distributable equity 443,894 875,989
Total equity 451,552 883,635
Non-current liabilities
Borrowings 533,145 97,966
Derivative liabilities 132,731
Contract liabilities 13,154 2,964
679,030 100,930
Current liabilities
Borrowings 20,096 6,995
Contract liabilities 3,137 2,601
Trade payables and accrued expenses 86,102 59,417
Other liabilities 26,578 29,952
Income taxes payable 126 198
Provisions 6,799 1,193
142,838 100,356
Total liabilities 821,868 201,286
Total equity and liabilities 1,273,420 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
ir@ascendispharma.com
Patti Bank
ICR Westwicke
+1 (415) 513-1284
patti.bank@westwicke.com
Last updated: Nov 2, 2022