Ascendis Pharma A/S Reports First Quarter 2017 Financial Results
"We are on track with all three of our development programs, according to our Vision 20/20 strategic plan to establish Ascendis as a leading, integrated rare disease company," said
Recent Corporate Highlights
- Continued to enroll subjects in the Phase 3 heiGHt Trial for TransCon Growth Hormone in pediatric growth hormone deficiency; the company remains on track to complete enrollment in the fourth quarter of 2017
- Presented data on all three rare disease endocrinology pipeline programs at
ENDO 2017, including four posters supporting the differentiated product profiles for TransCon PTH in hypoparathyroidism and TransCon CNP in achondroplasia, as well as four posters summarizing the phase 3 clinical program and auto-injector development for TransCon Growth Hormone - Announced data with TransCon CNP demonstrating potential reversal of the achondroplasia phenotype in a mouse disease model, and repeat dosing studies demonstrating the potential of TransCon PTH to be delivered with an infusion-like profile which may lead to a highly differentiated treatment for hypoparathyroidism
- Announced receipt of a letter from the
U.S. Food and Drug Administration indicating the Agency's concurrence with the company's proposed Pediatric Study Plan for the TransCon Growth Hormone development program - Ended the quarter with cash and cash equivalents of €157.6 million
First Quarter 2017 Financial Results
For the first quarter,
Research and development (R&D) costs for the quarter were €20.6 million compared to €16.2 million in the same quarter during 2016. Higher R&D costs in the 2017 quarter reflect an increase in development costs for TransCon PTH and TransCon CNP due to the continued development and progress with these two product candidates. This increase was partly offset by lower manufacturing costs for TransCon Growth Hormone in the first quarter of 2017 compared to the 2016 quarter.
General and administrative expenses for the first quarter of 2017 were €3.3 million compared to €2.9 million during the same quarter of 2016. The increase is primarily due to an increase in personnel costs, partly offset by a decrease in professional fees.
As of
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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 potential to become a leading, integrated rare disease company; (ii) our product pipeline; (iii) our expectations about when we will complete enrollment in the Phase 3 heiGHt Trial for TransCon Growth Hormone; (iv) our expectations regarding the potential of TransCon CNP and TransCon PTH; (v) our ability to apply the TransCon technology platform to build a leading rare disease commercial company and (vi) our expectations regarding our ability to create therapies with potential for best-in-class efficacy, safety and/or convenience. 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 Growth Hormone, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development of TransCon Growth Hormone, 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 Growth Hormone, 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
FINANCIAL TABLES FOLLOW
Ascendis Pharma A/S |
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Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income / (loss) |
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(In EUR'000s, except share and per share data) |
|||
Three Months Ended March 31, |
|||
2017 |
2016 |
||
Revenue |
372 |
1,258 |
|
Research and development costs |
(20,608) |
(16,242) |
|
General and administrative expenses |
(3,325) |
(2,908) |
|
Operating profit / (loss) |
(23,561) |
(17,892) |
|
Finance income |
130 |
20 |
|
Finance expenses |
(1,722) |
(2,764) |
|
Profit / (loss) before tax |
(25,153) |
(20,636) |
|
Tax on profit / (loss) for the period |
14 |
118 |
|
Net profit / (loss) for the period |
(25,139) |
(20,518) |
|
Other comprehensive income / (loss) |
|||
Items that may be reclassified subsequently to profit or loss: |
|||
Exchange differences on translating foreign operations |
4 |
21 |
|
Other comprehensive income / (loss) for the period, net of tax |
4 |
21 |
|
Total comprehensive income / (loss) for the period, net of tax |
(25,135) |
(20,497) |
|
Profit / (loss) for the period attributable to owners of the Company |
(25,139) |
(20,518) |
|
Total comprehensive income / (loss) for the period attributable to owners of the Company |
(25,135) |
(20,497) |
|
EUR |
EUR |
||
Basic earnings / (loss) per share |
(0.78) |
(0.82) |
|
Diluted earnings / (loss) per share |
(0.78) |
(0.82) |
|
Number of shares used for calculation (basic and diluted) |
32,428,908 |
25,128,242 |
|
Ascendis Pharma A/S |
|||
Unaudited Condensed Consolidated Interim Statements of Financial Position |
|||
(In EUR'000s) |
|||
March 31, |
December 31, |
||
2017 |
2016 |
||
Assets |
|||
Non-current assets |
|||
Intangible assets |
3,495 |
3,495 |
|
Property, plant and equipment |
2,559 |
2,350 |
|
Deposits |
267 |
268 |
|
6,321 |
6,113 |
||
Current assets |
|||
Trade receivables |
378 |
287 |
|
Other receivables |
1,921 |
640 |
|
Prepayments |
5,624 |
1,962 |
|
Income taxes receivable |
872 |
740 |
|
Cash and cash equivalents |
157,648 |
180,329 |
|
166,443 |
183,958 |
||
Total assets |
172,764 |
190,071 |
|
Equity and liabilities |
|||
Equity |
|||
Share capital |
4,365 |
4,354 |
|
Other reserves |
15,714 |
13,005 |
|
Retained earnings |
134,748 |
159,254 |
|
Total equity |
154,827 |
176,613 |
|
Current liabilities |
|||
Trade payables and other payables |
17,494 |
13,078 |
|
Deferred income |
94 |
94 |
|
Income taxes payable |
349 |
286 |
|
17,937 |
13,458 |
||
Total liabilities |
17,937 |
13,458 |
|
Total equity and liabilities |
172,764 |
190,071 |
|
Internal contact: |
Investor contact: |
Media contact: |
Scott T. Smith |
Patti Bank |
Ami Knoefler |
Chief Financial Officer |
Westwicke Partners |
SparkBioComm |
(650) 352-8389 |
(415) 513-1284 |
(650) 739-9952 |
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