Full Press Release Details
Ascendis Pharma A/S Reports Full-Year 2019 Financial Results
On track with 2020 corporate milestones
Top-line data from PaTH Forward phase 2 trial on track for
Conference call today at 4:30 p.m. Eastern Time
COPENHAGEN, Denmark, April 1, 2020 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its
innovative TransCon technologies to address unmet medical needs, today announced financial results for the full year ended December 31, 2019.
Following a transformative 2019, Ascendis remains on track with our corporate milestones for an even stronger 2020, said Jan Mikkelsen, Ascendis
Pharma s President and Chief Executive Officer. Our flexible, global workforce, corporate structure and supply chain, supported by our information technology infrastructure, have allowed our teams to continue work unabated, guided by our
corporate values and vision, and adapt to the global pandemic. We look forward to reporting our top-line results for the TransCon PTH PaTH Forward Trial mid-April, and
submitting our marketing applications for TransCon hGH in the United States (U.S.) and Europe, as planned, in the second and fourth quarters, respectively. I would like to acknowledge the extraordinary commitment of our employees, the patients in
our clinical trials, and the teams at our investigator sites to move forward during this time.
Corporate Highlights & Progress
Full Year 2019 Financial Results
For the full year 2019,
Ascendis Pharma reported a net loss of 218.0 million, or 4.69 per share (basic and diluted) compared to a net loss of 130.1 million, or 3.17 per share (basic and diluted) for the same period in 2018.
Revenue for 2019 was 13.4 million compared to 10.6 million during 2018. The increase reflects recognition of revenue related to our
strategic investment in VISEN Pharmaceuticals.
Research and development (R&D) costs for 2019 were 191.6 million compared to
140.3 million during 2018. Higher R&D costs in 2019 reflect an increase in personnel and external costs for development and manufacturing of TransCon hGH, TransCon PTH and TransCon CNP, and other research programs, including oncology.
General and administrative expenses for 2019 were 48.5 million compared to 25.1 million during 2018. The increase is primarily due
to higher personnel-related costs and other increasing costs of preparing to become a commercial organization.
As of December 31, 2019, Ascendis had
cash and cash equivalents of 598.1 million compared to 277.9 million as of December 31, 2018. As of December 31, 2019, Ascendis Pharma had 47,985,837 ordinary shares outstanding.
Conference Call and Webcast information
will host a conference call and webcast today at 4:30 p.m. Eastern Time (ET) to discuss its full year 2019 financial results. Details include:
| Date | April 1, 2020 | |
| Time | 4:30 p.m. ET | |
| Dial In (U.S.) | 844-290-3904 | |
| Dial In (International) | 574-990-1036 | |
| Access Code | 7387576 |
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at
www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.
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 utilizes its TransCon technologies to create new and
potentially best-in-class therapies.
Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates
in clinical development and is advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs.
Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg, Germany and Palo Alto, California.
For more information, please visit www.ascendispharma.com.
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 our 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) our plans to submit a BLA with the FDA in the second quarter of 2020 and a MAA in Europe in the fourth quarter of 2020 for
TransCon hGH, (ii) our phase 2 ACcomplisH Trial of TransCon CNP in children with achondroplasia, (iii) our ability to apply our TransCon platform to build a leading, fully integrated biopharma company, (iv) our expectations regarding
our ability to create new and potentially best-in-class therapies and (v) our product pipeline and expansion into additional therapeutic areas. We 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 we make,
including the following: unforeseen safety or efficacy results in our TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of TransCon hGH, TransCon
PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of 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; and our ability to obtain
additional funding, if needed, to support our business activities. 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 our business in general, see our current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including our most recent Annual Report on Form 20-F,
which we have filed with the SEC. Forward-looking statements do not reflect the potential impact of any future in-
licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do 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. April 2020 Ascendis Pharma A/S.
FINANCIAL TABLES FOLLOW
Consolidated Statements of Profit or Loss and Other Comprehensive Income / (loss)
(In EUR 000s, except share and per share data)
| Year ended December 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenue | 13,375 | 10,581 | ||||||
| Research and development costs | (191,621 | ) | (140,281 | ) | ||||
| General and administrative expenses | (48,473 | ) | (25,057 | ) | ||||
| Operating profit / (loss) | (226,719 | ) | (154,757 | ) | ||||
| Share of profit / (loss) of associate | (8,113 | ) | (321 | ) | ||||
| Finance income | 17,803 | 24,714 | ||||||
| Finance expenses | (1,221 | ) | (127 | ) | ||||
| Profit / (loss) before tax | (218,250 | ) | (130,491 | ) | ||||
| Tax on profit / (loss) for the year | 234 | 394 | ||||||
| Net profit / (loss) for the year | (218,016 | ) | (130,097 | ) | ||||
| Other comprehensive income / (loss) | ||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||
| Exchange differences on translating foreign operations | (37 | ) | 17 | |||||
| Other comprehensive income / (loss) for the year, net of tax | (37 | ) | 17 | |||||
| Total comprehensive income / (loss) for the year, net of tax | (218,053 | ) | (130,080 | ) | ||||
| Profit / (loss) for the year attributable to owners of the Company | (218,016 | ) | (130,097 | ) | ||||
| Total comprehensive income / (loss) for the year attributable to owners of the Company | (218,053 | ) | (130,080 | ) | ||||
| EUR | EUR | |||||||
| Basic and diluted earnings / (loss) per share | (4.69 | ) | (3.17 | ) | ||||
| Number of shares used for calculation (basic and diluted) | 46,506,862 | 41,085,237 |
Consolidated Statements of Financial Position
| December 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 3,495 | 3,495 | ||||||
| Property, plant and equipment | 45,069 | 4,325 | ||||||
| Investment in associate | 15,538 | 17,083 | ||||||
| Deposits | 1,463 | 1,158 | ||||||
| 65,565 | 26,061 | |||||||
| Current assets | ||||||||
| Receivable from associate | 804 | |||||||
| Trade receivables | 6 | |||||||
| Other receivables | 3,136 | 1,775 | ||||||
| Prepayments | 7,648 | 12,415 | ||||||
| Income taxes receivable | 1,473 | 849 | ||||||
| Cash and cash equivalents | 598,106 | 277,862 | ||||||
| 611,167 | 292,907 | |||||||
| Total assets | 676,732 | 318,968 | ||||||
| Equity and liabilities | ||||||||
| Equity | ||||||||
| Share capital | 6,443 | 5,659 | ||||||
| Distributable equity | 590,671 | 274,391 | ||||||
| Total equity | 597,114 | 280,050 | ||||||
| Non-current liabilities | ||||||||
| Lease liabilities | 30,720 | |||||||
| Other payables | 908 | |||||||
| 31,628 | ||||||||
| Current liabilities | ||||||||
| Lease liabilities | 5,899 | |||||||
| Contract liabilities | 858 | 6,902 | ||||||
| Trade payables | 27,765 | 19,740 | ||||||
| Other payables | 13,349 | 12,267 | ||||||
| Income taxes payable | 119 | 9 | ||||||
| 47,990 | 38,918 | |||||||
| Total liabilities | 79,618 | 38,918 | ||||||
| Total equity and liabilities | 676,732 | 318,968 |