World News: 21:02 GMT Thursday 30th May 2019. [Ascendis Pharma A/S via Globe Newswire via SPi World News]
COPENHAGEN, Denmark, May 30, 2019 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced financial results for the quarter ended March 31, 2019.
“In my view, 2019 has been the most transformative period in Ascendis history as we validated our TransCon platform with clinical evidence from the phase 3 heiGHt and fliGHt Trials for TransCon Growth Hormone, while continuing to execute on all three of our global endocrinology rare disease programs,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “Our long-term commitment to science and addressing unmet medical needs where we can make a difference for patients has never been stronger. I am pleased with our progress in endocrinology rare diseases and look forward to providing detailed data, as well as introducing our oncology programs, at the upcoming R&D Day on June 26 in New York City.”
For the first quarter, Ascendis Pharma reported a net loss of €53.6 million, or €1.24 per share (basic and diluted) compared to a net loss of €41.4 million, or €1.07 per share (basic and diluted) for the same period in 2018.
Revenue for the first quarter was €5.4 million compared to €28 thousand in the same quarter of 2018. The increase reflects recognition of revenue from the sale of licenses in connection with the formation of the strategic investment in VISEN Pharmaceuticals.
Research and development (R&D) costs for the first quarter were €51.3 million compared to €30.5 million during the same period in 2018. Higher R&D costs in 2019 reflect an increase in costs for the manufacturing of validation batches of TransCon hGH required as part of the regulatory approval process, partly offset by decreasing costs for the phase 3 clinical program; for TransCon PTH, an increase in costs associated with continued development and progress, including manufacturing of clinical material and pen device, and initiation of the phase 2 PaTH Forward clinical trial; for TransCon CNP, lower manufacturing and preclinical costs, partly offset by phase 2 enabling activities; and increased headcount in R&D functions.
General and administrative expenses for the first quarter were €10.4 million compared to €4.7 million during the same period in 2018. The increase is primarily due to higher personnel costs and other increasing costs of preparing to become a commercial organization.
As of March 31, 2019, the company had cash and cash equivalents of €696.7 million compared to €277.9 million as of December 31, 2018. This includes net proceeds to the company of $539.4 million, or €480.3 million, after deducting the underwriters’ commissions and the company’s estimated offering expenses, from an underwritten public offering of 4,791,667 American Depositary Shares (“ADSs”), completed in March 2019. As of March 31, 2019, Ascendis Pharma had 46,927,115 ordinary shares outstanding.
Ascendis Pharma is hosting an R&D Day for investors in New York City on June 26, 2019 from 9:00 a.m. to 1:00 p.m. Eastern Time (ET). The company will provide an update on its endocrinology rare disease and oncology research and development activities.
Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. ET to discuss its first quarter 2019 financial results. Details include:
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at . A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.
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 technologies to create new and potentially best-in-class therapies.
Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and has established oncology as its second therapeutic area of focus. 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 .
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 FDA for TransCon hGH to treat pediatric GHD in the first half of 2020, (ii) our plans to initiate a phase 2 trial of TransCon CNP in children with achondroplasia in the third quarter of 2019, (iii) our ability to apply our TransCon platform to build a leading, fully integrated biopharma company, (iv) our expectations regarding our ability to create potentially best-in-class therapies and (v) 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 and potential commercialization 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, 2018, which we filed with the SEC on April 3, 2019. 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.
FINANCIAL TABLES FOLLOW
Scott T. Smith
Chief Financial Officer
Head of Global Communications
Globe Newswire: 21:02 GMT Thursday 30th May 2019
SPi News is published by Sector Publishing Intelligence Ltd.
© Sector Publishing Intelligence Ltd 2019. [Admin Only]
Sector Publishing Intelligence Ltd.
Agriculture House, Acland Road, DORCHESTER, Dorset DT1 1EF United Kingdom
Registered in England and Wales number 07519380.