Ascendis Pharma A/S Reports Full Year 2018 Financial Results
– Rare disease endocrinology pipeline continues to advance, with
significant 2019 milestones anticipated –
– Phase 3 heiGHt Trial results showcase potential of TransCon™ technologies and
support company algorithm for product innovation –
– Conference call today at
“We have achieved clinical validation for all three of our rare disease endocrinology programs, showing we can translate product concepts into therapeutic candidates that make a meaningful difference for patients,” said
Corporate Highlights &
- Presented positive top-line data from the phase 3 heiGHt Trial for TransCon Growth Hormone (hGH), a once-weekly growth hormone therapy for the treatment of pediatric growth hormone deficiency (GHD). Results of the trial demonstrated that TransCon hGH has comparable safety and tolerability with superior efficacy to a daily hGH (Genotropin®). These data were highlighted as an oral presentation at
ENDO2019, the annual meeting of the Endocrine Society.
- Completed last patient visit in the fliGHt Trial, which is evaluating TransCon hGH in subjects who switch from daily hGH; on track to report top-line data in the second quarter of 2019. Including long-term safety data from the ongoing enliGHten Trial, the company plans a clinical database lock for the TransCon hGH phase 3 program in the third quarter of 2019, and intends to submit a Biologics License Application (BLA) with the
U.S. Food and Drug Administration( FDA) for TransCon hGH to treat pediatric GHD in the first half of 2020.
- Initiated PaTH Forward, a global phase 2 trial designed to evaluate the safety, tolerability and efficacy of TransCon PTH in adult subjects with hypoparathyroidism (HP). The trial is also evaluating a titration regimen for the complete withdrawal of standard of care (i.e., active vitamin D and calcium supplements). TransCon PTH is a long-acting prodrug of parathyroid hormone (PTH) in development as a potential replacement therapy for HP designed to achieve and maintain a steady concentration of PTH within the normal range for 24 hours a day. The company expects to report top-line results from PaTH Forward in the fourth quarter of 2019.
- Reported preliminary phase 1 data for TransCon CNP, a long-acting prodrug of C-type natriuretic peptide (CNP). Ascendis expects to initiate a phase 2 trial in children with achondroplasia in the third quarter of this year. In addition, the company is conducting the ACHieve Study, a natural history study that aims to provide important observational insights into the experience of children living with achondroplasia.
- Introduced Vision 3x3, the company’s strategic roadmap through 2025 to achieve sustainable growth through multiple approaches and established oncology as a second independent therapeutic area of focus.
- Appointed Sigurd Okkels, Ph.D., as Senior Vice President of Product Development. Dr. Okkels brings more than 20 years of experience in international leadership positions at
Novo Nordisk, Profound Pharma/Maxygen, Nycomed, Takeda and, most recently, as an independent consultant. He has been responsible for numerous pharmaceutical projects at all stages of development, from preclinical and launch to life cycle management. Dr. Okkels holds a Ph.D. in Biochemistry and Molecular Biology.
- Subsequent to year-end 2018, Ascendis completed an underwritten public offering of 4,791,667 American Depositary Shares (“ADSs”), each of which represents one ordinary share of Ascendis, at a price to the public of
$120.00per ADS. The company received net proceeds from the offering of approximately $539.8 million, or €476.9 million at the date of closing, after deducting the underwriters’ commissions and the company’s estimated offering expenses.
- Ended 2018 with cash and cash equivalents of €277.9 million.
Full Year 2018 Financial Results
For the full year 2018,
Revenue for 2018 was €10.6 million compared to €1.5 million during 2017. The increase in revenue reflects the sale of licenses recognized as part of forming the strategic investment in
Research and development (R&D) costs for 2018 were €140.3 million compared to €99.6 million during 2017. Higher R&D costs in 2018 reflect an increase in clinical trial costs for the phase 3 clinical program for TransCon hGH, costs for preparation of the manufacturing of validation batches required as part of the regulatory approval process, ongoing development of our proprietary auto-injector for use with TransCon hGH, costs associated with the company’s phase 1 clinical trials of TransCon PTH and TransCon CNP, phase 2 enabling activities for both programs, and increased headcount in R&D functions.
General and administrative expenses for the 2018 year were €25.1 million compared to €13.5 million during 2017. The increase is primarily due to higher personnel costs and site costs, increased professional fees, recruitment costs and initial costs of building out a commercial organization.
Conference Call and Webcast information
|Date||Wednesday, April 3, 2019|
|Time||4:30 p.m. ET|
|Dial In (U.S.)||844-290-3904|
|Dial In (International)||574-990-1036|
A live audio webcast of the event will be available in the Investors and News section of the
Ascendis is headquartered in
For more information, please visit www.ascendispharma.com.
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
FINANCIAL TABLES FOLLOW
|Ascendis Pharma A/S|
|Consolidated Statements of Profit or Loss and Other Comprehensive Income / (loss)|
|(In EUR'000s, except share and per share data)|
|Year ended December 31,|
|Research and development costs||(140,281||)||(99,589||)|
|General and administrative expenses||(25,057||)||(13,482||)|
|Operating profit / (loss)||(154,757||)||(111,541||)|
|Share of profit / (loss) of associate||(321||)||-|
|Profit / (loss) before tax||(130,491||)||(124,374||)|
|Tax on profit / (loss) for the year||394||477|
|Net profit / (loss) for the year||(130,097||)||(123,897||)|
|Other comprehensive income / (loss)|
|Items that may be reclassified subsequently to profit or loss:|
|Exchange differences on translating foreign operations||17||65|
|Other comprehensive income / (loss) for the year, net of tax||17||65|
|Total comprehensive income / (loss) for the year, net of tax||(130,080||)||(123,832||)|
|Profit / (loss) for the year attributable to owners of the Company||(130,097||)||(123,897||)|
|Total comprehensive income / (loss) for the year attributable to owners of the Company||(130,080||)||(123,832||)|
|Basic and diluted earnings / (loss) per share||(3.17||)||(3.68||)|
|Number of shares used for calculation (basic and diluted)||41,085,237||33,626,305|
|Ascendis Pharma A/S|
|Consolidated Statements of Financial Position|
|December 31,||December 31,|
|Property, plant and equipment||4,325||2,557|
|Investment in associate||17,083||-|
|Income taxes receivable||849||778|
|Cash and cash equivalents||277,862||195,351|
|Equity and liabilities|
|Income taxes payable||9||-|
|Total equity and liabilities||318,968||210,979|
Scott T. SmithChief Financial Officer (650) 352-8389 firstname.lastname@example.org Media contact: Ami KnoeflerHead of Global Communications(650) 739-9952 email@example.com Investor contact: Patti Bank Westwicke Partners(415) 513-1284 firstname.lastname@example.org
Source: Ascendis Pharma A/S