Full Press Release Details
Ascendis Pharma Reports Second Quarter 2023 Financial Results
Expect to resubmit NDA to FDA for TransCon PTH in October 2023; EC decision
on MAA for TransCon PTH expected during the fourth quarter of 2023
U.S. and EU regulatory authorities endorsed ApproaCH as a
pivotal Phase 3 trial of TransCon CNP in children with achondroplasia; enrollment completed, and topline results expected in second half of 2024
Raising full year 2023 U.S. SKYTROFA * revenue expectations to
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, September 5, 2023 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results
for the second quarter ended June 30, 2023 and provided business updates.
We have built a fully integrated Endocrinology Rare Disease
franchise with a growing commercial reach and are on our way to achieving our Vision 3x3, including regulatory approval for three differentiated product candidates by 2025, said Jan Mikkelsen, Ascendis Pharma s President and Chief
Executive Officer. With a proven U.S. and expanding global commercial infrastructure positioned to capture the multi-billion-dollar opportunities that each represents, coupled with an R&D engine for label expansion and future innovation
for new patient populations, Ascendis has many routes to realize long-term profitability and sustainability.
Corporate Highlights
| Q2-2022 | Q3-2022 | Q4-2022 | Q1-2023 | Q2-2023 | ||||||||||||||||
| SKYTROFA revenue (millions) | 4.4 | 12.3 | 17.1 | 31.6 | 35.9 |
Second Quarter 2023 Financial Results
the second quarter of 2023 was 47.4 million compared to 6.2 million during the same period in 2022. The increase was primarily attributable to higher SKYTROFA revenue of 35.9 million compared to
4.4 million in the same period last year.
Research and development (R&D) costs for the second quarter were 105.0 million
compared to 90.4 million during the same period in 2022. This increase was primarily due to higher development costs for Ascendis Pharma Oncology programs (TransCon IL-2 and TransCon TLR7/8 Agonist), 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 second quarter were 70.3 million compared to 56.6 million during the
same period in 2022. This increase was primarily due to higher external commercial expenses related to SKYTROFA, pre-launch activities for SKYTROFA outside the U.S., global
pre-launch activities for TransCon PTH, higher employee related expenses, and an increase in other general and administrative expenses attributable to organizational growth.
Net finance income was 26.4 million in the second quarter compared to 61.7 million in the same period in 2022.
For the second quarter of 2023, Ascendis Pharma reported a net loss of 121.4 million, or 2.16 per share (basic and diluted) compared to a net
loss of 81.3 million, or 1.46 per share (basic and diluted) for the same period in 2022.
As of June 30, 2023, Ascendis Pharma had
cash, cash equivalents, and marketable securities totaling 431.1 million compared to 742.9 million as of December 31, 2022. As of June 30, 2023, Ascendis Pharma had 57,335,496 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 second quarter 2023 financial results.
Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. 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 TransCon technology platform 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, Berlin 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) Ascendis plan to resubmit an NDA for TransCon PTH in October 2023; (ii) the timing and results of the EC decision on the TransCon PTH MAA; (iii) the timing of topline results of the ApproaCH trial; (iv) Ascendis
expectations regarding 2023 SKYTROFA revenues in the United States; (v) Ascendis ability to achieve its Vision 3x3; (vi) Ascendis expectations regarding regulatory approval for three independent product candidates by 2025; (vii)
Ascendis ability to capture the opportunities presented by its product candidates and realize long-term profitability and sustainability; (viii) Ascendis SKYTROFA revenue expectations; (ix) Ascendis expectations regarding
the launch of SKYTROFA in Germany; (x) Ascendis expectations regarding EU approval at Lonza for a high-capacity drug substance manufacturing site; (xi) the timing of Topline results from Phase 3 foresiGHt trial and the potential for
the first label expansion opportunity; (xii) Ascendis expectations regarding the launch of TransCon PTH in Germany; (xiii) the timing of topline results from the ApproaCH trial; (xiv) the timing of
one-year follow-up data from the OLE portion of the Phase 2 ACcomplisH trials; (xv) the timing of topline/interim analysis from Phase 2 dose-expansion cohorts of transcendIT-101 and IL-Believe trials; (xvi) the ability of the new TransCon technology carrier platform to unlock large market opportunities where high volume and low-cost manufacturing is required; (xvii) the potential best-in-class weekly and monthly administration profiles of
Ascendis new TransCon technology carrier platform; (xviii) Ascendis ability to apply its TransCon technology platform to build a leading, fully integrated global biopharma company; and (xix) 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, TransCon, and SKYTROFA are trademarks owned by the Ascendis Pharma group. September 2023 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, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | 47,393 | 6,160 | 80,982 | 12,988 | ||||||||||||
| Cost of sales | 12,929 | 1,086 | 17,551 | 5,332 | ||||||||||||
| Gross profit | 34,464 | 5,074 | 63,431 | 7,656 | ||||||||||||
| Research and development costs | 105,021 | 90,383 | 211,134 | 173,576 | ||||||||||||
| Selling, general and administrative expenses | 70,281 | 56,584 | 136,820 | 104,002 | ||||||||||||
| Operating profit / (loss) | (140,838 | ) | (141,893 | ) | (284,523 | ) | (269,922 | ) | ||||||||
| Share of profit / (loss) of associate | (7,451 | ) | (1,166 | ) | (8,677 | ) | (6,039 | ) | ||||||||
| Finance income | 35,761 | 71,127 | 80,374 | 84,171 | ||||||||||||
| Finance expenses | 9,334 | 9,434 | 18,652 | 14,833 | ||||||||||||
| Profit / (loss) before tax | (121,862 | ) | (81,366 | ) | (231,478 | ) | (206,623 | ) | ||||||||
| Income taxes (expenses) | 429 | 47 | (868 | ) | (195 | ) | ||||||||||
| Net profit / (loss) for the period | (121,433 | ) | (81,319 | ) | (232,346 | ) | (206,818 | ) | ||||||||
| Attributable to owners of the Company | (121,433 | ) | (81,319 | ) | (232,346 | ) | (206,818 | ) | ||||||||
| Basic and diluted earnings / (loss) per share | (2.16 | ) | (1.46 | ) | (4.14 | ) | (3.68 | ) | ||||||||
| Number of shares used for calculation (basic and diluted) | 56,218,257 | 55,805,486 | 56,155,441 | 56,260,248 | ||||||||||||
| Net profit / (loss) for the period | (121,433 | ) | (81,319 | ) | (232,346 | ) | (206,818 | ) | ||||||||
| Other comprehensive income / (loss) | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Exchange differences on translating foreign operations | (1,016 | ) | (757 | ) | (1,803 | ) | (332 | ) | ||||||||
| Other comprehensive income / (loss) for the period, net of tax | (1,016 | ) | (757 | ) | (1,803 | ) | (332 | ) | ||||||||
| Total comprehensive income / (loss) for the period, net of tax | (122,449 | ) | (82,076 | ) | (234,149 | ) | (207,150 | ) | ||||||||
| Attributable to owners of the Company | (122,449 | ) | (82,076 | ) | (234,149 | ) | (207,150 | ) |
Consolidated Statements of Financial Position
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 4,606 | 4,828 | ||||||
| Property, plant and equipment | 125,362 | 129,095 | ||||||
| Investment in associate | 14,111 | 22,932 | ||||||
| Other receivables | 2,066 | 1,920 | ||||||
| Marketable securities | 7,492 | |||||||
| 146,145 | 166,267 | |||||||
| Current assets | ||||||||
| Inventories | 167,919 | 130,673 | ||||||
| Trade receivables | 20,212 | 11,910 | ||||||
| Income tax receivable | 1,360 | 883 | ||||||
| Other receivables | 14,127 | 12,833 | ||||||
| Prepayments | 42,958 | 31,717 | ||||||
| Marketable securities | 36,880 | 290,688 | ||||||
| Cash and cash equivalents | 394,222 | 444,767 | ||||||
| 677,678 | 923,471 | |||||||
| Total assets | 823,823 | 1,089,738 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 7,699 | 7,675 | ||||||
| Distributable equity | 57,142 | 255,673 | ||||||
| Total equity | 64,841 | 263,348 | ||||||
| Non-current liabilities | ||||||||
| Borrowings | 479,374 | 482,956 | ||||||
| Derivative liabilities | 86,385 | 157,950 | ||||||
| Contract liabilities | 949 | 14,213 | ||||||
| 566,708 | 655,119 | |||||||
| Current liabilities | ||||||||
| Borrowings | 26,564 | 25,421 | ||||||
| Contract liabilities | 4,146 | |||||||
| Trade payables and accrued expenses | 122,120 | 101,032 | ||||||
| Other liabilities | 22,860 | 31,989 | ||||||
| Income tax payables | 5,773 | 5,490 | ||||||
| Provisions | 10,811 | 7,339 | ||||||
| 192,274 | 171,271 | |||||||
| Total liabilities | 758,982 | 826,390 | ||||||
| Total equity and liabilities | 823,823 | 1,089,738 |
| 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 |