LEXINGTON, Mass. and AMSTERDAM, the Netherlands, May 09, 2017 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company developing transformative therapies for patients with severe medical needs, today reported its financial results for the first quarter of 2017 and highlighted recent progress in advancing its pipeline.
"In early 2017, we continued to make progress across our strategic priorities, including our gene therapy programs in hemophilia B, Huntington's disease and congestive heart failure," stated Matthew Kapusta, chief executive officer of uniQure. "Over the past few months, AMT-060 received Breakthrough Therapy and PRIME designation based on the promising data from our ongoing Phase I/II study, and we look forward to presenting updated data from the study in July at ISTH. We also initiated discussions with the FDA regarding planning for a pivotal study, and expect additional interactions with regulators in 2017 as we prepare for late-stage development."
"In addition, we recently presented promising, new preclinical data in Huntington's disease from a large animal model, and remain on track to initiate an IND-enabling toxicology study in the second half of 2017," added Mr. Kapusta. "We also continue to advance, in collaboration with BMS, our preclinical studies of S100A1 in heart failure, as well as other early stage product candidates targeting CNS and liver-directed diseases, and we look forward to providing an update on our progress this year."
First Quarter 2017 and Recent Significant Corporate Highlights
Upcoming Events in Second-Quarter and Mid-2017
Financial Highlights
Cash Position: As of March 31, 2017, the Company held cash and cash equivalents of $120.3 million, compared with $132.5 million as of December 31, 2016. The decrease in cash was primarily related to the advancement of its clinical and preclinical gene therapy targets, general corporate activities and capital expenditures related to its facilities in Lexington, MA and Amsterdam. The Company intends to significantly reduce capital expenditures in 2017 and 2018 and realize operational cost savings from the strategic restructuring initiated in November 2016 and the withdrawal of Glybera in October 2017. As a result of these initiatives, the Company expects its cash on hand will be sufficient to fund operations into 2019.
Revenues: Revenue for the first quarter of 2017 was $3.3 million compared with $4.3 million in the first quarter of 2016. The reduction in the current year period was driven by a decrease in collaboration revenue compared to the prior year period. The reduction was primarily due to the timing of various reimbursable activities, including the production of preclinical material for the Company's S100A1 gene therapy that occurred in the prior year period.
R&D Expenses: Research and development expenses for the first quarter of 2017 were $17.0 million compared with $16.7 million in the first quarter of 2016. The increase was primarily related to higher operating expenses and depreciation related to our Amsterdam facilities.
SG&A Expenses: Selling, general and administrative expenses for the first quarter of 2017 were $6.4 million compared with $7.3 million in the first quarter of 2016. The decrease was primarily related to one-time costs related to our CEO transition incurred in the prior year period.
Net Loss: The net loss for the first quarter of 2017 was $20.3 million, or $0.80 per share, compared with $22.3 million, or $0.90 per share, for the first quarter of 2016.
About uniQure
uniQure is delivering on the promise of gene therapy - single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary and partnered gene therapies to treat patients with liver/metabolic, central nervous system and cardiovascular diseases. www.uniQure.com
uniQure Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the implementation and effects of the Company's new strategic and organizational changes, the development of our gene therapy product candidates, the success of our collaborations and the risk of cessation, delay or lack of success of any of our ongoing or planned clinical studies and/or development of our product candidates. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with corporate restructuring, collaboration arrangements, our and our collaborators' clinical development activities, regulatory oversight, product commercialization and intellectual property claims, as well as the risks, uncertainties and other factors described under the heading "Risk Factors" in uniQure's 2016 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2017. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
uniQure N.V. UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
March 31, | December 31, | ||||||
2017 | 2016 | ||||||
in thousands, except share and per share amounts | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 120,271 | $ | 132,496 | |||
Accounts receivable and accrued income | 1,233 | 3,680 | |||||
Accounts receivable and accrued income from related party | 517 | 5,500 | |||||
Prepaid expenses | 1,129 | 996 | |||||
Other current assets | 579 | 1,274 | |||||
Total current assets | 123,729 | 143,946 | |||||
Non-current assets | |||||||
Property, plant and equipment, net | 35,241 | 35,702 | |||||
Intangible assets, net | 8,357 | 8,324 | |||||
Goodwill | 471 | 465 | |||||
Other non-current assets | 1,837 | 1,828 | |||||
Total non-current assets | 45,906 | 46,319 | |||||
Total assets | $ | 169,635 | $ | 190,265 | |||
Current liabilities | |||||||
Accounts payable | $ | 3,954 | $ | 5,524 | |||
Accrued expenses and other current liabilities | 7,154 | 9,766 | |||||
Current portion of long-term debt | 2,443 | 605 | |||||
Current portion of deferred rent | 697 | 684 | |||||
Current portion of deferred revenue | 6,225 | 6,142 | |||||
Total current liabilities | 20,473 | 22,721 | |||||
Non-current liabilities | |||||||
Long-term debt, net of current portion | 17,920 | 19,631 | |||||
Deferred rent, net of current portion | 8,090 | 6,781 | |||||
Deferred revenue, net of current portion | 75,404 | 75,612 | |||||
Contingent consideration | 1,989 | 1,838 | |||||
Other non-current liabilities | 32 | 51 | |||||
Total non-current liabilities | 103,435 | 103,913 | |||||
Total liabilities | 123,908 | 126,634 | |||||
Commitments and contingencies (see note 13) | |||||||
Shareholders' equity | |||||||
Ordinary shares, €0.05 par value: 60,000,000 shares authorized at March 31, 2017, and December 31, 2016, and 25,475,894 and 25,257,420 shares issued and outstanding at March 31, 2017, and December 31, 2016, respectively. | 1,604 | 1,593 | |||||
Additional paid-in-capital | 466,688 | 464,653 | |||||
Accumulated other comprehensive loss | (6,235 | ) | (6,557 | ) | |||
Accumulated deficit | (416,330 | ) | (396,058 | ) | |||
Total shareholders' equity | 45,727 | 63,631 | |||||
Total liabilities and shareholders' equity | $ | 169,635 | $ | 190,265 |
uniQure N.V. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
Three months ended March 31, | |||||||||
2017 | 2016 | ||||||||
in thousands, except share and per share amounts | |||||||||
Total revenues | $ | 3,321 | 4,295 | ||||||
Operating expenses: | |||||||||
Research and development expenses | (16,994 | ) | (16,706 | ) | |||||
Selling, general and administrative expenses | (6,358 | ) | (7,298 | ) | |||||
Total operating expenses | (23,352 | ) | (24,004 | ) | |||||
Other income | 316 | 445 | |||||||
Loss from operations | (19,715 | ) | (19,264 | ) | |||||
Non operating items, net | (557 | ) | (2,478 | ) | |||||
Loss before income tax benefit / (expense) | (20,272 | ) | (21,742 | ) | |||||
Income tax benefit / (expense) | - | (557 | ) | ||||||
Net loss | $ | (20,272 | ) | $ | (22,299 | ) | |||
Basic and diluted net loss per common share | $ | (0.80 | ) | $ | (0.90 | ) | |||
Weighted average shares used in computing basic and diluted net loss per common share | 25,443,609 | 24,696,643 | |||||||
uniQure Contacts: Maria E. Cantor Direct: 339-970-7536 Mobile: 617-680-9452 m.cantor@uniQure.com Tom Malone Direct: 339-970-7558 Mobile: 339-223-8541 t.malone@uniQure.com Eva M. Mulder Direct: +31 20 240 6103 Mobile: +31 6 52 33 15 79 e.mulder@uniQure.com
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