Human gene therapy uniQure announced audited results for the fourth quarter and year ending December 31, 2015. Revenue for 2015 was €9.4 million.
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As of December 31, 2015, uniQure held cash and cash equivalents of €203.5 million, compared with €53.2 million as of December 31, 2014.
The increase was due to the consideration received from BMS during the period and uniQure’s follow-on offering in April 2015, offset in part by cash used in research, development and general corporate activities.
Revenue for 2015 was €9.4 million, compared with €4.7 million in 2014. These revenues are primarily related to uniQure’s collaboration agreements with Bristol-Myers Squibb and Chiesi, as well as Glybera product sales, which commenced in the third quarter of 2015.
Cost of goods sold in 2015 was €0.6 million, compared with zero in 2014. Cost of goods sold includes the cost of Glybera product sales and amortization of specific Glybera-related license agreements, which were required to be expensed upon the initiation of commercialization in the third quarter of 2015.
Research and development expenses were €46.8 million in 2015, compared to €33.9 million in 2014.
The increase is related to the continuation of uniQure’s Phase I/II clinical study of AMT-060 in hemophilia B, the continued progression of uniQure’s other product candidates and increased activity in uniQure’s U.S. facility.
Selling, general and administrative expenses were €19.3 million in 2015, compared with €11.2 million in 2014. The increase was primarily due to expenses related to consultants and professional fees associated with business development, expenses related to uniQure’s follow-on offering conducted in April 2015 and other general and administrative activities.
Other gains/losses were a loss of €0.2 million for 2015, compared to a gain of €5.8 million in 2014. The loss was primarily attributable to the impact of foreign currency exchange rates on uniQure’s dollar-denominated deposits.
In the third quarter of 2015, uniQure incurred a one-time, non-recurring impairment charge on certain Glybera-related intangible assets of €11.6 million related to the revision of uniQure’s forecasted number of patients treated with Glybera and certain reimbursement-related developments in Europe.
The net loss for the fourth quarter of 2015 was €14.1 million, or €0.58 per share, compared with €11.2 million, or €0.62 per share, for the fourth quarter of 2014. The net loss for the full years 2015 and 2014 was €71.5 million, or €3.24 per share and €37.0 million, or €2.16 per share, respectively. ■