Ascendis Pharma A/S Reports Second Quarter 2018 Financial Results
- Continued advancement of endocrinology rare disease pipeline, paving way for application of TransCon™ technology in a new therapeutic area -
- Conference Call Today at
“We continue to execute on our strategic goals, advancing towards our vision to build a fully integrated biopharma company,” said
Recent Corporate Highlights
- Continued execution of the TransCon Growth Hormone (hGH) phase 3 program, with the observed aggregate data from the heiGHt Trial continuing to demonstrate a safety profile consistent with the published safety profile of the active comparator, Genotropin. TransCon hGH is in development as a once-weekly therapy for pediatric growth hormone deficiency.
- Completing enrollment in the fliGHt (switch) Trial, which evaluates TransCon hGH in 150 subjects who have previously been treated with daily growth hormone.
- Provided development update on TransCon PTH, a long-acting prodrug of parathyroid hormone. Following ongoing review of the global regulatory and commercial landscape, the company plans to conduct a phase 2 trial to provide experience with dosing regimens of TransCon PTH, and with titration of standard of care, and to conduct a global phase 3 pivotal trial.
- Continued execution, as planned, of the ongoing phase 1 trial for TransCon CNP, a long-acting prodrug of C-type natriuretic peptide.
- Granted Orphan Drug Designation (ODD) by the
U.S. Food and Drug Administrationfor TransCon PTH. ODD is provided to drugs that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.
- Presented research posters on TransCon PTH and the TransCon technology at the
European Congress of Endocrinologyin May and the annual Controlled Release Societymeeting, respectively.
- Ended the quarter with cash and cash equivalents of €352.6 million.
Second Quarter 2018 Financial Results
For the second quarter,
Research and development (R&D) costs for the second quarter were €40.2 million compared to €21.9 million in the same quarter of 2017. Increased R&D costs in the 2018 quarter reflect costs for preparation of the manufacturing of validation batches for TransCon Growth Hormone, and increasing costs of the ongoing clinical trials for this product candidate, as well the ongoing project costs for TransCon PTH and TransCon CNP.
General and administrative expenses for the second quarter of 2018 were €5.2 million compared to €3.2 million in the same quarter of 2017. The increase is primarily due to an increase in personnel costs.
Conference Call and Webcast information
|Date||Wednesday, August 29, 2018|
|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 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™ technology to create new and potentially best-in-class therapies.
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 development plan for TransCon PTH, (ii) our ability to apply our platform technology to build a leading, fully integrated biopharma company, (iii) our expectations regarding our ability to create potentially best-in-class therapies and (iv) our product pipeline. 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 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 (
FINANCIAL TABLES TO FOLLOW
|Ascendis Pharma A/S|
|Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income / (loss)|
|(In EUR'000s, except share and per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development costs||(40,235)||(21,880)||(70,775)||(42,488)|
|General and administrative expenses||(5,226)||(3,231)||(9,888)||(6,556)|
|Operating profit / (loss)||(45,443)||(24,667)||(80,617)||(48,228)|
|Profit / (loss) before tax||(22,876)||(30,743)||(64,358)||(55,896)|
|Tax on profit / (loss) for the period||99||37||206||51|
|Net profit / (loss) for the period||(22,777)||(30,706)||(64,152)||(55,845)|
|Other comprehensive income / (loss)|
|Items that may be reclassified subsequently to profit or loss:|
|Exchange differences on translating foreign operations||2||42||(7)||46|
|Other comprehensive income / (loss) for the period, net of tax||2||42||(7)||46|
|Total comprehensive income / (loss) for the period, net of tax||(22,775)||(30,664)||(64,159)||(55,799)|
|Profit / (loss) for the period attributable to owners of the Company||(22,777)||(30,706)||(64,152)||(55,845)|
|Total comprehensive income / (loss) for the period attributable to owners of the Company||(22,775)||(30,664)||(64,159)||(55,799)|
|Basic and diluted earnings / (loss) per share||(0.55)||(0.94)||(1.60)||(1.72)|
|Number of shares used for calculation (basic and diluted)||41,650,907||32,502,555||40,182,701||32,465,935|
|Ascendis Pharma A/S|
|Unaudited Condensed Consolidated Interim Statements of Financial Position|
|June 30,||December 31,|
|Property, plant and equipment||2,597||2,557|
|Income taxes receivable||1,279||778|
|Cash and cash equivalents||352,601||195,351|
|Equity and liabilities|
|Trade payables and other payables||36,614||23,768|
|Income taxes payable||25||-|
|Total equity and liabilities||368,864||210,979|
Chief Financial Officer
Head of Global Communications