Ascendis Pharma A/S Reports First Quarter 2020 Financial Results
– On track for filing
– Expanded commercial organization to support planned global launch of TransCon hGH –
– Conference call today at
“We continue to execute on our vision to build a leading biopharma company. In addition to remaining on track to achieve our corporate milestones for 2020, we continue to expand our organization to support the planned global launch of our first commercial product, TransCon Growth Hormone,” said
He continued, “Additionally, we recently reported positive top-line data from the fixed dose, blinded portion of PaTH Forward evaluating TransCon PTH. This portion of the phase 2 trial met its key objectives, marking a major potential advance in helping hypoparathyroidism patients who are in urgent need of an effective PTH replacement therapy. And, with the appointment of
Corporate Highlights & Progress
- For TransCon hGH, an investigational long-acting prodrug of somatropin (human growth hormone or hGH), remain on track for planned submission of a Biologics License Application (BLA) to the
U.S. Food and Drug Administration(FDA) in the second quarter, and a Marketing Authorisation Application (MAA) to the European Medicines Agencynow in the third quarter, both for pediatric growth hormone deficiency (GHD).
- Submitted an Investigational New Drug (IND) amendment to initiate the global, phase 3 foresiGHt Trial evaluating TransCon hGH in adults with GHD. Enrollment is expected to begin later this year.
- Remain on track to initiate a phase 3 trial with TransCon hGH in pediatric GHD in
Japanin the fourth quarter.
- Received Orphan Drug Designation from the FDA for TransCon hGH as a treatment for GHD.
- Announced positive top-line results from the four-week fixed dose, blinded portion of PaTH Forward, a global phase 2 trial evaluating the safety, tolerability and efficacy of TransCon PTH, an investigational long-acting prodrug of parathyroid hormone (PTH), in adult subjects with hypoparathyroidism. Data showed that within only four weeks TransCon PTH replaced the current standard of care for 82 percent of patients with hypoparathyroidism.
- Remain on track to report six-month data from the open-label extension portion of the PaTH Forward Trial during the third quarter, and to initiate a global phase 3 trial of TransCon PTH in
North America, Europeand Asiain the fourth quarter.
- Remain on track to submit the first IND or equivalent in oncology in the fourth quarter for TransCon TLR7/8 Agonist.
- Announced the appointment of
Jesper Høilandas Global Chief Commercial Officer. Mr. Høilandhas over 25 years of global senior leadership experience in biopharma, including over 20 years of global commercial experience in growth hormone.
- Opened the company’s new facility in
Redwood City, Californiato advance its pipeline of oncology programs.
- Ended the first quarter 2020 with cash and cash equivalents of €534.4 million.
First Quarter 2020 Financial Results
For the first quarter,
Revenue for the first quarter was €2.2 million compared to €5.4 million in the same quarter of 2019. The decrease was due to a lower amount of license and service revenue being recognized, partly offset by sale of clinical supply to Visen.
Research and development (R&D) costs for the first quarter were €57.5 million compared to €51.3 million during the same period in 2019. Higher R&D costs in 2020 reflect an increase in personnel-related costs, overhead costs allocated to R&D, and the continued progress in development of the company’s product candidates.
General and administrative expenses for the first quarter were €17.9 million compared to €10.4 million during the same period in 2019. The increase is primarily due to additional personnel-related costs, higher IT and facility costs, and continued build out of the company’s commercial capabilities.
Conference Call and Webcast information
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About Ascendis Pharma’s Pipeline
- TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin (human growth hormone or hGH) that releases somatropin with the identical amino acid sequence and size as daily growth hormone, in phase 3 development as a once-weekly treatment for growth hormone deficiency (GHD).
- TransCon PTH, an investigational long-acting prodrug of parathyroid hormone (PTH) in phase 2 development as a once-daily replacement therapy for hypoparathyroidism (HP) designed to replace PTH at physiologic levels for 24 hours every day, and address both short-term symptoms and long-term complications of the disease.
- TransCon CNP, an investigational long-acting prodrug of C-type natriuretic peptide (CNP) in phase 2 development as a therapy for children with achondroplasia (ACH), the most common form of dwarfism, for which there is no FDA-approved treatment. TransCon CNP is designed to provide continuous exposure of CNP at safe, therapeutic levels via a single, weekly subcutaneous dose.
Additionally, the company has established oncology as its second therapeutic area of focus and plans to submit an IND or equivalent in the fourth quarter of 2020 for its first oncology product candidate.
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 progress to achieve our corporate milestones for 2020, (ii) our planned global launch of TransCon Growth Hormone, (iii) our plans to submit our marketing applications for TransCon hGH in
FINANCIAL TABLES FOLLOW
|Consolidated Statements of Profit or Loss and Other Comprehensive Income / (loss)|
|(In EUR'000s, except share and per share data)|
|Three Months Ended
|Research and development costs||(57,515||)||(51,259||)|
|General and administrative expenses||(17,915||)||(10,436||)|
|Operating profit / (loss)||(73,205||)||(56,281||)|
|Share of profit / (loss) of associate||(1,515||)||(1,852||)|
|Profit / (loss) before tax||(63,394||)||(53,707||)|
|Tax on profit / (loss) for the year||77||70|
|Net profit / (loss) for the year||(63,317||)||(53,637||)|
|Other comprehensive income / (loss)|
|Items that may be reclassified subsequently to profit or loss:|
|Exchange differences on translating foreign operations||86||559|
|Other comprehensive income / (loss) for the year, net of tax||86||559|
|Total comprehensive income / (loss) for the year, net of tax||(63,231||)||(53,078||)|
|Profit / (loss) for the year attributable to owners of the Company||(63,317||)||(53,637||)|
|Total comprehensive income / (loss) for the year attributable to owners of the Company||(63,231||)||(53,078||)|
|Basic and diluted earnings / (loss) per share||(1.32||)||(1.24||)|
|Number of shares used for calculation (basic and diluted)||47,985,837||43,371,559|
|Consolidated Statements of Financial Position|
|Property, plant and equipment||49,761||45,069|
|Investment in associate||15,307||15,538|
|Receivable from associate||1,312||804|
|Income taxes receivable||921||1,473|
|Cash and cash equivalents||534,381||598,106|
|Equity and liabilities|
|Income taxes payable||209||119|
|Total equity and liabilities||621,407||676,732|
|Investor contact:||Media contact:|
|(415) 513-1284||(650) 739-9952|
Source: Ascendis Pharma