Ascendis Pharma A/S Reports Second Quarter 2019 Financial Results
– TransCon hGH moves towards Biologics License Application submission following completion of heiGHt and fliGHt Trials –
– Global reach of endocrinology rare disease programs expands –
– Conference call today at
“The achievements across our three rare disease endocrinology product candidates during the first half of 2019 show we are on track to fulfill our ’Vision 3x3’ to become a leading biopharma company,” said
Corporate Highlights &
- On track for a planned Biologics License Application (BLA) in the first half of 2020 and a marketing application (MAA) in
Europein the second half of 2020 for TransCon hGH, a long-acting prodrug of human growth hormone (hGH) in development as a once-weekly therapy for pediatric growth hormone deficiency (GHD). Results from the phase 3 program demonstrated statistically significantly greater efficacy (heiGHt Trial) and comparable safety and tolerability to a daily hGH (heiGHt Trial and fliGHt Trial). Additionally, Ascendis is working in collaboration with VISEN Pharmaceuticalsto initiate a phase 3 trial later this year in subjects with pediatric GHD in China, and plans to initiate a global program for adult GHD in 2020.
- Introduced the TransCon hGH Auto-Injector and dual-chamber cartridge (DCC) combination product as planned into the enliGHten Trial, a long-term extension trial for TransCon hGH. Data from the enliGHten Trial, including long-term safety data, will support the planned BLA and planned MAA for TransCon hGH.
- Ongoing enrollment in the PaTH Forward Trial, a global, phase 2 trial designed to evaluate the safety and efficacy of TransCon PTH in adult subjects with hypoparathyroidism. TransCon PTH is a long-acting prodrug of parathyroid hormone (PTH) in development for the treatment of adult hypoparathyroidism. TransCon PTH has been designed to provide physiologic levels of PTH for 24 hours a day, seven days a week.
- Completed filing of an Investigational New Drug (IND) application with the
U.S. Food and Drug Administration( FDA) for initiation of the ACcomplisH Trial, a global, phase 2, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of TransCon CNP at escalating doses in children with achondroplasia (ACH). TransCon CNP is a long-acting prodrug of C-type natriuretic peptide (CNP) that has been designed to provide continuous exposure to CNP at therapeutic levels with once-weekly dosing. All subjects who complete the ACcomplisH Trial will have the opportunity to receive TransCon CNP in a long-term safety extension trial.
- Introduced the company’s oncology vision and programs.
- Ended the second quarter of 2019 with cash and cash equivalents of €690.4 million.
Second Quarter 2019 Financial Results
For the second quarter,
Revenue for the second quarter was €3.2 million compared to €18 thousand in the same quarter of 2018. The increase reflects recognition of revenue related to our strategic investment in
Research and development (R&D) costs for the second quarter were €43.8 million compared to €40.2 million during the same period in 2018. Higher R&D costs in 2019 primarily reflect an increase in personnel-related costs to support development and manufacturing of TransCon hGH, TransCon PTH and TransCon CNP, as well as increased costs for other research programs, partly offset by a decrease in costs associated with TransCon hGH due to completion of the phase 3 heiGHt Trial.
General and administrative expenses for the second quarter were €11.0 million compared to €5.2 million during the same period in 2018. The increase is primarily due to higher personnel-related costs and other increasing costs of preparing to become a commercial organization.
Conference Call and Webcast information
|Date||Wednesday, August 28, 2019|
|Time||4:30 p.m. ET|
|Dial In (U.S.)||844-290-3904|
|Dial In (International)||574-990-1036|
A live webcast of the conference call will be available on 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|
|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||(43,826||)||(40,235||)||(95,085||)||(70,775||)|
|General and administrative expenses||(10,960||)||(5,226||)||(21,396||)||(9,888||)|
|Operating profit / (loss)||(51,575||)||(45,443||)||(107,856||)||(80,617||)|
|Share of profit / (loss) of associate||(2,262||)||-||(4,114||)||-|
|Profit / (loss) before tax||(58,969||)||(22,876||)||(112,676||)||(64,358||)|
|Tax on profit / (loss) for the period||65||99||135||206|
|Net profit / (loss) for the period||(58,904||)||(22,777||)||(112,541||)||(64,152||)|
|Other comprehensive income / (loss)|
|Items that may be reclassified subsequently to profit or loss:|
|Exchange differences on translating foreign operations||(594||)||2||(35||)||(7||)|
|Other comprehensive income / (loss) for the period, net of tax||(594||)||2||(35||)||(7||)|
|Total comprehensive income / (loss) for the period, net of tax||(59,498||)||(22,775||)||(112,576||)||(64,159||)|
|Profit / (loss) for the period attributable to owners of the Company||(58,904||)||(22,777||)||(112,541||)||(64,152||)|
|Total comprehensive income / (loss) for the period attributable to owners of the Company||(59,498||)||(22,775||)||(112,576||)||(64,159||)|
|Basic and diluted earnings / (loss) per share||(1.25||)||(0.55||)||(2.48||)||(1.60||)|
|Number of shares used for calculation (basic and diluted)||47,190,717||41,650,907||45,291,688||40,182,701|
|Ascendis Pharma A/S|
|Unaudited Condensed Consolidated Interim Statements of Financial Position|
|June 30,||December 31,|
|Property, plant and equipment||42,537||4,325|
|Investment in associate||16,885||17,083|
|Income taxes receivable||1,133||849|
|Cash and cash equivalents||690,355||277,862|
|Equity and liabilities|
|Income taxes payable||52||9|
|Total equity and liabilities||767,157||318,968|
Internal contact: Scott T. Smith Chief Financial Officer (650) 352-8389 firstname.lastname@example.org Media contact: Ami Knoefler Head 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