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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 4:30 p.m. Eastern Time -

COPENHAGEN, Denmark, Aug. 29, 2018 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq:ASND), a biopharmaceutical company that utilizes its innovative TransCon technology to address significant unmet medical needs, today announced financial results for the quarter ended June 30, 2018.

“We continue to execute on our strategic goals, advancing towards our vision to build a fully integrated biopharma company,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “We intend to provide sustainable growth from multiple sources, both from our three independent rare disease endocrinology product opportunities, and by applying our TransCon technology platform in new therapeutic areas. Our proprietary platform technologies and our mindset for innovation are the foundations of this ability to develop differentiated products that address major unmet medical needs.”

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 Administration for 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 Endocrinology in May and the annual Controlled Release Society meeting, respectively.
  • Ended the quarter with cash and cash equivalents of €352.6 million.

Second Quarter 2018 Financial Results

For the second quarter, Ascendis Pharma reported a net loss of €22.8 million, or €0.55 per share (basic and diluted) compared to a net loss of €30.7 million, or €0.94 per share (basic and diluted) for the same period in 2017.

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.

As of June 30, 2018, the company had cash and cash equivalents of €352.6 million compared to €348.4 million as of March 31, 2018. As of June 30, 2018, Ascendis had 41,841,590 ordinary shares outstanding.

Conference Call and Webcast information

Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. Eastern Time (ET) to discuss its second quarter 2018 financial results. Details include:

DateWednesday, August 29, 2018
Time4:30 p.m. ET
Dial In (U.S.)844-290-3904
Dial In (International)574-990-1036
Access Code4777928

A live audio webcast of the event will be available in 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.

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 utilizes its TransCon technology to create new and potentially best-in-class therapies.

Ascendis Pharma currently has a pipeline of three wholly-owned, independent rare disease endocrinology product candidates in clinical development. Additionally, Ascendis Pharma has multi-product collaborations with Sanofi in diabetes and Genentech in the field of ophthalmology and continues to expand into additional therapeutic areas for both internal and external development.

Ascendis is headquartered in Copenhagen, Denmark, with 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 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 (SEC), including our Annual Report on Form 20-F for the year ended December 31, 2017, which we filed with the SEC on March 28, 2018. 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.© August 2018 Ascendis Pharma A/S.

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,
         
  2018  2017  2018  2017 
         
 Revenue18  444  46  816 
 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) 
         
 Finance income22,573  158  16,270  288 
 Finance expenses(6)  (6,234)  (11)  (7,956) 
 Profit / (loss) before tax  (22,876)    (30,743)    (64,358)    (55,896) 
         
 Tax on profit / (loss) for the period99  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 operations2  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) 
         
         
   EUR    EUR    EUR    EUR  
 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   
 (In EUR'000s)   
     
  June 30, December 31,
  2018 2017
 Assets   
 Non-current assets   
 Intangible assets3,495 3,495
 Property, plant and equipment2,597 2,557
 Deposits1,115 293
  7,207  6,345
     
 Current assets   
 Trade receivables17 188
 Other receivables1,826 1,410
 Prepayments5,934 6,907
 Income taxes receivable1,279 778
 Cash and cash equivalents352,601 195,351
  361,657  204,634
 Total assets368,864  210,979
     
 Equity and liabilities   
 Equity   
 Share capital5,619 4,967
 Distributable equity326,606 182,244
 Total equity332,225  187,211
     
 Current liabilities   
 Trade payables and other payables36,614 23,768
 Income taxes payable25 -
 Total liabilities36,639  23,768
     
 Total equity and liabilities368,864  210,979
     

Internal contact:
Scott T. Smith      
Chief Financial Officer      
(650) 352-8389    
ir@ascendispharma.com    

Media contact:
Ami Knoefler
Head of Global Communications 
(650) 739-9952  
ack@ascendispharma.com

Investor contact:
Patti Bank
Westwicke Partners
(415) 513-1284
patti.bank@westwicke.com 

Wednesday, August 29, 2018 - 16:01