Full Press Release Details
Ascendis Pharma Reports Third Quarter 2023 Financial Results
European Commission decision for TransCon PTH expected this
month; if approved, first
European Union launch planned in Germany in January 2024
TransCon PTH NDA resubmission to FDA expected before mid-November
Completed enrollment in the Phase 3 ApproaCH Trial; initiated TransCon CNP infant trial in the
third quarter 2023; expect to initiate combination trial of TransCon CNP and TransCon hGH in the fourth quarter 2023
SKYTROFA Q3 revenue of 47.0 million, increasing full year 2023 SKYTROFA revenue
expectations to 170 175 million
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, November 7, 2023 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results
for the third quarter ended September 30, 2023 and provided business updates.
This quarter marks an important milestone for Ascendis on our
path to become a leading, sustainable biopharma company, where we began our journey to extend our SKYTROFA U.S. market value leadership globally with our first EU product launch in Germany, said Jan Mikkelsen, Ascendis Pharma s President
and Chief Executive Officer. Expected approval in the EU for our second product, TransCon PTH, this month demonstrates the value of following our algorithm for product innovation.
Corporate Highlights
| Q3-2022 | Q4-2022 | Q1-2023 | Q2-2023 | Q3-2023 | ||||||||||||||||
| SKYTROFA revenue (millions) | 12.3 | 17.1 | 31.6 | 35.9 | 47.0 |
Third Quarter 2023 Financial Results
Total revenue for the third quarter of 2023 was 48.0 million compared to 15.3 million during the same period in 2022. The increase was
primarily attributable to higher SKYTROFA revenue of 47.0 million compared to 12.3 million in the same period last year.
and development (R&D) costs for the third quarter were 111.4 million compared to 97.4 million during the same period in 2022. This increase was primarily due to higher development costs for the Oncology and Ophthalmology
programs, increasing clinical trial activities for TransCon CNP, and higher employee-related costs, and was partly offset by lower development costs for TransCon hGH.
Selling, general, and administrative (SG&A) expenses for the third quarter were 63.6 million compared to 60.7 million during the
same period in 2022. This increase was primarily due to higher employee related expenses and other expenses attributable to organizational growth.
finance expenses were 20.4 million in the third quarter compared to 20.9 million in the same period in 2022.
For the third quarter
of 2023, Ascendis Pharma reported a net loss of 162.2 million, or 2.88 per share (basic and diluted) compared to a net loss of 169.0 million, or 3.03 per share (basic and diluted) for the same period in 2022.
As of September 30, 2023, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling 455.4 million compared to
742.9 million as of December 31, 2022. As of September 30, 2023, Ascendis Pharma had 57,656,568 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 third quarter 2023 financial results.
To participate in the
call, please dial (800) 445-7795 (domestic) or +1 (785) 424-1699 (international), and reference passcode ASNDQ323. The link to the live webcast will also be available on
the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of our 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 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 Germany (Heidelberg and Munich) and the United States (Palo
Alto and Redwood City, California, and Princeton, New Jersey). Please visit 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 the European Commission decision for TransCon PTH and the potential approval of TransCon PTH in the EU; (ii) Ascendis plan to resubmit an NDA for TransCon PTH before
mid-November; (iii) Ascendis plans to launch TransCon PTH, if approved, in Germany in January 2024; (iv) Ascendis expectations regarding the initiation of its combination trial of TransCon CNP
and TransCon hGH; (v) Ascendis expectations regarding 2023 SKYTROFA revenues; (vi) Ascendis ability to become a leading, sustainable biopharma company; (vii) Ascendis ability to extend its SKYTROFA U.S. market value
leadership globally; (viii) the timing of Topline results from Phase 3 foresiGHt trial and the potential for a label expansion opportunity; (ix) the timing of topline results from the ApproaCH trial; (x) the timing of one-year follow-up data from the OLE portion of the ACcomplisH trial; (xi) Ascendis plan to file an IND amendment or similar for COACH; (xii) the ability for a
combination therapy of TransCon CNP and TransCon hGH to provide greater annualized height velocity than CNP alone and address the comorbidities of achondroplasia; (xiii) the timing of initial data from indication-specific cohorts in the Phase 2
portion of the Phase 1/2 IL-Believe Trial; (xiv) the timing of initial data from the Phase 2 portion of transcendIT-101; (xv) Ascendis ability to apply its
TransCon technology platform to build a leading, fully integrated global biopharma company; and (xvi) 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, distributors and service providers for
Ascendis products and product candidates; unforeseen safety or efficacy results in Ascendis development programs or on-market products; unforeseen expenses related to commercialization of any
approved Ascendis products; unforeseen expenses related to Ascendis development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis business generally; delays in the
development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; 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, the effects on its business from the worldwide COVID-19 pandemic and ongoing conflicts such as that 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 February 16, 2023 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, and TransCon are trademarks owned by the Ascendis Pharma group. November 2023 Ascendis Pharma
| 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 |
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, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | 48,034 | 15,290 | 129,016 | 28,278 | ||||||||||||
| Cost of sales | 7,388 | 1,693 | 24,938 | 7,025 | ||||||||||||
| Gross profit | 40,646 | 13,597 | 104,078 | 21,253 | ||||||||||||
| Research and development costs | 111,439 | 97,431 | 322,573 | 271,006 | ||||||||||||
| Selling, general and administrative expenses | 63,614 | 60,671 | 200,435 | 164,675 | ||||||||||||
| Operating profit / (loss) | (134,407 | ) | (144,505 | ) | (418,930 | ) | (414,428 | ) | ||||||||
| Share of profit / (loss) of associate | (6,794 | ) | (3,696 | ) | (15,471 | ) | (9,736 | ) | ||||||||
| Finance income | 4,142 | 20,326 | 76,985 | 73,797 | ||||||||||||
| Finance expenses | 24,519 | 41,247 | 35,640 | 25,381 | ||||||||||||
| Profit / (loss) before tax | (161,578 | ) | (169,122 | ) | (393,056 | ) | (375,748 | ) | ||||||||
| Income taxes (expenses) | (645 | ) | 167 | (1,513 | ) | (28 | ) | |||||||||
| Net profit / (loss) for the period | (162,223 | ) | (168,955 | ) | (394,569 | ) | (375,776 | ) | ||||||||
| Attributable to owners of the Company | (162,223 | ) | (168,955 | ) | (394,569 | ) | (375,776 | ) | ||||||||
| Basic and diluted earnings / (loss) per share | (2.88 | ) | (3.03 | ) | (7.02 | ) | (6.70 | ) | ||||||||
| Number of shares used for calculation (basic and diluted) | 56,272,698 | 55,831,561 | 56,194,956 | 56,115,782 | ||||||||||||
| Net profit / (loss) for the period | (162,223 | ) | (168,955 | ) | (394,569 | ) | (375,776 | ) | ||||||||
| Other comprehensive income / (loss) | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Exchange differences on translating foreign operations | 571 | (2,207 | ) | (1,232 | ) | (2,538 | ) | |||||||||
| Other comprehensive income / (loss) for the period, net of tax | 571 | (2,207 | ) | (1,232 | ) | (2,538 | ) | |||||||||
| Total comprehensive income / (loss) for the period, net of tax | (161,652 | ) | (171,162 | ) | (395,801 | ) | (378,314 | ) | ||||||||
| Attributable to owners of the Company | (161,652 | ) | (171,162 | ) | (395,801 | ) | (378,314 | ) |
Consolidated Statements of Financial Position
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 4,495 | 4,828 | ||||||
| Property, plant and equipment | 125,535 | 129,095 | ||||||
| Investment in associate | 8,116 | 22,932 | ||||||
| Other receivables | 2,142 | 1,920 | ||||||
| Marketable securities | 7,492 | |||||||
| 140,288 | 166,267 | |||||||
| Current assets | ||||||||
| Inventories | 189,132 | 130,673 | ||||||
| Trade receivables | 26,794 | 11,910 | ||||||
| Income tax receivables | 1,644 | 883 | ||||||
| Other receivables | 21,595 | 12,833 | ||||||
| Prepayments | 38,327 | 31,717 | ||||||
| Marketable securities | 14,165 | 290,688 | ||||||
| Cash and cash equivalents | 441,268 | 444,767 | ||||||
| 732,925 | 923,471 | |||||||
| Total assets | 873,213 | 1,089,738 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 7,742 | 7,675 | ||||||
| Distributable equity | (81,175 | ) | 255,673 | |||||
| Total equity | (73,433 | ) | 263,348 | |||||
| Non-current liabilities | ||||||||
| Borrowings | 549,483 | 387,555 | ||||||
| Lease liabilities | 90,103 | 95,401 | ||||||
| Derivative liabilities | 93,353 | 157,950 | ||||||
| Contract liabilities | 949 | 14,213 | ||||||
| 733,888 | 655,119 | |||||||
| Current liabilities | ||||||||
| Borrowings | 11,824 | 11,630 | ||||||
| Lease liabilities | 14,433 | 13,791 | ||||||
| Contract liabilities | 4,030 | |||||||
| Trade payables and accrued expenses | 121,552 | 101,032 | ||||||
| Other liabilities | 33,660 | 31,989 | ||||||
| Income tax payables | 6,478 | 5,490 | ||||||
| Provisions | 20,781 | 7,339 | ||||||
| 212,758 | 171,271 | |||||||
| Total liabilities | 946,646 | 826,390 | ||||||
| Total equity and liabilities | 873,213 | 1,089,738 |