Ascendis Pharma A/S Reports Second Quarter 2015 Financial Results

COPENHAGEN, Denmark, Aug. 24, 2015 /PRNewswire/ -- Ascendis Pharma A/S (Nasdaq: ASND), a clinical stage biotechnology company that applies its innovative TransCon technology to address significant unmet medical needs, today announced financial results for the three and six months ended June 30, 2015.

Ascendis Pharma reported a cash balance of 137.9 million at June 30, 2015.

"The first half of 2015 has been marked by important milestones for Ascendis, including the successful completion of our IPO and the recent reporting of positive top-line data from our Phase 2 pediatric study of once-weekly TransCon Growth Hormone," stated Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma.  "With our strong balance sheet, we believe we are well positioned to complete a Pivotal Phase 3 pediatric study of TransCon Growth Hormone, and plan to initiate this study in mid-2016."

Mr. Mikkelsen continued, "Once-weekly TransCon Growth Hormone is unique among long-acting development programs in that it releases unmodified growth hormone into the blood stream, thus preserving the same mode-of-action as gold-standard daily growth hormone therapies.  We believe that replacement therapy with unmodified growth hormone is a key component to successfully demonstrating the favorable efficacy, safety, tolerability and immunogenic profile that we achieved in our Phase 2 pediatric study."

Three months ended June 30, 2015 financial results
Total revenue for the three months ended June 30, 2015 was 1.9 million, a decrease of 2.0 million, or 50%, compared to total revenue of 3.9 million for the three months ended June 30, 2014. This change was primarily driven by a decrease of 1.5 million in revenue from our collaboration with United Therapeutics as a result of the collaboration period ending at June 30, 2014. Revenue from our collaboration with Sanofi decreased by 0.4 million whereas revenue from our collaboration with Genentech was in line with the same period in 2014. 

Research and development costs were 12.6 million for the three months ended June 30, 2015, an increase of 7.9 million, or 170%, compared to research and development costs of 4.7 million for the three months ended June 30, 2014. The increase is primarily attributable to a 7.3 million increase in external costs related to our TransCon hGH project for which we reported positive top-line data for a Phase 2 pediatric study in July 2015, and a 0.6 million increase in external costs related to our TransCon Treprostinil project, which we assumed after the termination of our collaboration with United Therapeutics in 2014. Other research and development expenses were in line with the similar period in 2014. Research and development costs included non-cash share-based payment expenses of 0.1 million for the three months ended June 30, 2015 which was in line with the 0.1 million for the three months ended June 30, 2014.

General and administrative expenses were 2.1 million for the three months ended June 30, 2015, an increase of 0.7 million, or 52%, compared to general and administrative expenses of 1.4 million for the three months ended June 30, 2014. The increase is primarily due to an increase in administrative personnel costs of 0.9 million, partially offset by a decrease in professional fees of 0.7 million. Other general and administrative expenses increased by a net amount of 0.5 million, primarily due to additional costs of operating as a publicly listed company. General and administrative expenses included non-cash share-based payment expenses of 0.3 million for the three months ended June 30, 2015, and 0.2 million for the three months ended June 30, 2014.

Net loss for the three months ended June 30, 2015 was 15.0 million, or 0.63 per share (basic and diluted), compared to a net loss of 2.1 million, or 0.20 per share (basic and diluted), for the three months ended June 30, 2014.  The weighted average number of shares used to calculate basic and diluted net loss per share was 23,970,242 and 10,801,948, respectively, for the three months ended June 30, 2015 and 2014.  As of June 30, 2015, there were 24,196,826 ordinary shares and 2,638,778 warrants outstanding.  Each warrant entitles a warrant holder to subscribe for one ordinary share. As of June 30, 2015, the weighted average exercise price of all outstanding warrants was approximately 6.05.

Six months ended June 30, 2015 financial results
Total revenue for the six months ended June 30, 2015 was 4.0 million, a decrease of 3.9 million, or 49%, compared to total revenue of 7.9 million for the six months ended June 30, 2014. This change was primarily driven by a decrease of 3.2 million in revenue from our collaboration with United Therapeutics as a result of the collaboration period ending at June 30, 2014. Revenue from our collaboration with Sanofi decreased by 0.6 million whereas revenue from our collaboration with Genentech decreased by 0.1 million compared to the same period in 2014.

Research and development costs were 20.0 million for the six months ended June 30, 2015, an increase of 11.8 million, or 142%, compared to research and development costs of 8.2 million for the six months ended June 30, 2014. This increase is primarily attributable to a 9.9 million increase in external costs related to our TransCon hGH project for which we reported positive top-line data for a Phase 2 pediatric study in July 2015, and a 1.5 million increase in external costs related to our TransCon Treprostinil project, which we assumed after the termination of our collaboration with United Therapeutics in 2014. Costs related to basic research in support of new and existing development programs increased by 0.7 million, whereas other research and development expenses decreased by 0.3 million. Research and development costs included non-cash share-based payment expenses of 0.3 million for the six months ended June 30, 2015 and 0.2 million for the six months ended June 30, 2014.

General and administrative expenses were 4.5 million for the six months ended June 30, 2015, an increase of 2.1 million, or 93%, compared to general and administrative expenses of 2.4 million for the six months ended June 30, 2014. The increase is primarily due to an increase in administrative personnel costs of 1.4 million in support of our IPO and as part of operating as a publicly listed company. Other general and administrative expenses increased by a net amount of 0.7 million, primarily due to additional costs of operating as a publicly listed company. General and administrative expenses included non-cash share-based payment expenses of 0.7 million for the six months ended June 30, 2015, and 0.4 million for the six months ended June 30, 2014.

Net loss for the six months ended June 30, 2015 was 13.6 million, or 0.60 per share (basic and diluted), compared to a net loss of 2.6 million, or 0.24 per share (basic and diluted), for the six months ended June 30, 2014.  The weighted average number of shares used to calculate basic and diluted net loss per share was 22,683,493 and 10,801,948, respectively, for the six months ended June 30, 2015 and the six months ended June 30, 2014. 

About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology, which combines the benefits of prodrug and sustained release technologies, to develop a pipeline of best-in-class therapeutics that address significant unmet medical needs.  The TransCon technology can be applied to existing drug therapies, including proteins, peptides and small molecules, to create prodrugs that provide for the predictable and sustained release of an unmodified parent drug.   

The Ascendis Pharma pipeline includes TransCon Growth Hormone, a proprietary program that has completed Phase 2 studies in adults and children with growth hormone deficiency. 

To read full press release, please click here.

Help employers find you! Check out all the jobs and post your resume.