Ascendis Pharma A/S Reports Full Year 2015 Financial Results
"2015 was a transformative year for Ascendis highlighted by our positive results from our TransCon Growth Hormone Phase 2 pediatric study last July," commented
Mr. Mikkelsen continued, "TransCon Growth Hormone is the only long-acting growth hormone in development that has been shown to provide sustained-release of native growth hormone into the bloodstream at the same peak and total exposure levels as approved daily growth hormone, differentiating its mode-of-action from other long-acting growth hormone programs in development. Preparations remain on track to support the initiation of our TransCon Growth Hormone pivotal Phase 3 heiGHt pediatric trial, which we expect to begin in mid-2016."
2015 and Recent Highlights
- Reported positive top-line results in
July 2015 in a Phase 2 study of TransCon Growth Hormone in pediatric growth-hormone deficient (GHD) patients - Presented positive final Phase 2 pediatric GHD data at the 54th Annual Meeting of the
European Society for Paediatric Endocrinology (ESPE) inOctober 2015 - An oral presentation and two poster abstracts on TransCon Growth Hormone were presented at the
Endocrine Society's 98th Annual Meeting & Expo (ENDO 2016) held inApril 2016 - Completed successful IPO in
February 2015 , with$111.5 million in net proceeds raised - Several key additions made to Ascendis' executive management team in 2015 and early 2016
Jonathan A. Leff , M.D. joined as Senior Vice President and CMO- Kennett Sprogøe, Ph.D. promoted to Senior Vice President, Product Innovation
Flemming Steen Jensen joined as Senior Vice President, Product Supply
Full Year 2015 Consolidated Financial Results
Revenue for the year ended
Research and development costs were €40.5 million for the year ended
General and administrative expenses were €9.4 million for the year ended
Net finance income increased by €6.7 million to €8.3 million for the year ended
Net loss for the year ended
As of
About
Additionally,
The TransCon technology combines the benefits of prodrug and sustained-release technologies, and is the key driver of
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 our product pipeline, including our plans to initiate our global Phase 3 heiGHt trial in GHD children in mid-2016. 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 lead development program TransCon Growth Hormone or other development programs; unforeseen expenses related to the development of TransCon Growth Hormone or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of TransCon Growth Hormone 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
FINANCIAL TABLES FOLLOW
Ascendis Pharma A/S |
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Consolidated Statements of Profit or Loss and Other Comprehensive Income |
|||
(In EUR'000s, except share and per share data) |
|||
Year ended December 31, |
|||
2015 |
2014 |
||
Revenue |
8,118 |
13,983 |
|
Research and development costs |
(40,528) |
(19,698) |
|
General and administrative expenses |
(9,415) |
(6,274) |
|
Operating profit / (loss) |
(41,825) |
(11,989) |
|
Finance income |
11,048 |
1,877 |
|
Finance expenses |
(2,797) |
(228) |
|
Profit / (loss) before tax |
(33,574) |
(10,340) |
|
Tax on profit / (loss) for the year |
652 |
682 |
|
Net profit / (loss) for the year |
(32,922) |
(9,658) |
|
Other comprehensive income |
|||
Items that may be reclassified subsequently to profit or loss: |
|||
Exchange differences on translating foreign operations |
(14) |
(14) |
|
Other comprehensive income / (loss) for the year, net of tax |
(14) |
(14) |
|
Total comprehensive income / (loss) for the year, net of tax |
(32,936) |
(9,672) |
|
Profit / (loss) for the year attributable to owners of the Company |
(32,922) |
(9,658) |
|
Total comprehensive income / (loss) for the year attributable to owners of the Company |
(32,936) |
(9,672) |
|
Basic earnings / (loss) per share |
(1.39) |
(0.85) |
|
Diluted earnings / (loss) per share |
(1.39) |
(0.85) |
|
Number of shares used for calculation (basic) |
23,766,783 |
11,406,929 |
|
Number of shares used for calculation (diluted) |
23,766,783 |
11,406,929 |
Ascendis Pharma A/S |
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Consolidated Statements of Financial Position |
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(In EUR'000s) |
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December 31, |
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2015 |
2014 |
||
Assets |
|||
Non-current assets |
|||
Intangible assets |
3,495 |
3,495 |
|
Property, plant and equipment |
2,355 |
1,874 |
|
Deposits |
270 |
140 |
|
6,120 |
5,509 |
||
Current assets |
|||
Trade receivables |
1,064 |
1,292 |
|
Other receivables |
338 |
210 |
|
Prepayments |
3,819 |
620 |
|
Income taxes receivable |
784 |
873 |
|
Cash and cash equivalents |
119,649 |
50,167 |
|
125,654 |
53,162 |
||
Total assets |
131,774 |
58,671 |
|
Equity and liabilities |
|||
Equity |
|||
Share capital |
3,374 |
2,272 |
|
Other reserves |
5,678 |
3,979 |
|
Retained earnings / (accumulated deficit) |
111,277 |
39,559 |
|
Total equity |
120,329 |
45,810 |
|
Current liabilities |
|||
Trade payables and other payables |
8,373 |
4,956 |
|
Deferred income |
3,072 |
7,905 |
|
11,445 |
12,861 |
||
Total liabilities |
11,445 |
12,861 |
|
Total equity and liabilities |
131,774 |
58,671 |
Investor contact:
Chief Business Officer
(650) 352-8389
ir@ascendispharma.com
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