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Share Name | Share Symbol | Market | Type |
---|---|---|---|
uniQure NV | NASDAQ:QURE | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.13 | 2.78% | 4.81 | 4.46 | 4.80 | 4.965 | 4.66 | 4.78 | 452,909 | 23:41:32 |
LEXINGTON, Mass. and AMSTERDAM, the Netherlands, March 15, 2017 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company developing transformative therapies for patients with severe medical needs, today announces its financial results for the year 2016 and provides an update on company progress.
"In 2016, we made significant progress across all of our core programs and implemented strategic changes that have strengthened our organization and enhanced focus on our key priorities," stated Matthew Kapusta, chief executive officer of uniQure. "We enter 2017 with a solid financial position and strong clinical data to advance our hemophilia B program into a Phase III study, as well as to progress our gene therapy candidates in Huntington's disease and congestive heart failure towards IND filings. We believe the achievement of these objectives will deliver meaningful value to shareholders."
Recent Highlights from 2016
Financial Highlights
Cash Position: As of December 31, 2016, the Company held cash and cash equivalents of $132.5 million, compared with $221.6 million as of December 31, 2015. 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 state-of-the-art manufacturing facility in Lexington, Massachusetts and the build-out of its new research facility in Amsterdam, the Netherlands. 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. As a result of these initiatives, the Company expects its cash on hand will be sufficient to fund operations into 2019.
Revenues: Revenue for 2016 was $25.1 million, compared with $10.6 million in 2015 and $6.1 million in 2014. The increases are driven by research activity associated with S100A1 for heart failure, which are fully reimbursed by BMS in accordance with the Company's collaboration agreement.
R&D Expenses: Research and development expenses were $72.5 million in 2016, compared with $59.1 million in 2015 and $43.8 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 intensification of the Company's activities to support the research of S100A1, the continued progression of uniQure's preclinical candidate for Huntington's disease, increased activity in the Company's U.S. facility and ongoing studies associated with the Company's collaboration with 4D Molecular Therapeutics to develop next-generation vector serotypes.
SG&A Expenses: Selling, general and administrative expenses were $26.0 million in 2016, compared with $23.4 million in 2015 and $17.1 million in 2014.
Other income, generated from research and development subsidies, was $1.5 million in 2016 compared with $0.8 million in 2015 and $1.0 million in 2014.
Net Loss: The net loss for the fourth quarter of 2016 was $14.7 million, or $0.58 per share, compared with $16.9 million, or $0.69 per share, for the fourth quarter of 2015. The net loss for the full years 2016, 2015 and 2014 was $73.4 million, or $2.93 per share, $82.1 million, or $3.72 per share, and $49.8 million, or $2.91 per share, respectively.
Form S-3 registration: In March 2015, the Company filed a "shelf registration statement" on Form F-3 with the Securities and Exchange Commission. Now that the Company reports as a domestic issuer, the F-3 registration statement is no longer effective, and therefore the Company today will file a new shelf registration statement on Form S-3. This will provide the Company with important financial flexibility for advancing its programs in the future. The Company has no immediate plans for any financing transaction.
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 reorganizations and strategic shifts, 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 2015 Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2016 and its 2016 Annual Report on Form 10-K filed on or about the date hereof. 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 CONSOLIDATED BALANCE SHEETS | |||||||||
December 31, | December 31, | ||||||||
2016 | 2015 | ||||||||
in thousands, except share and per share amounts | |||||||||
Current assets | |||||||||
Cash and cash equivalents | $ | 132,496 | $ | 221,626 | |||||
Accounts receivable and accrued income | 3,680 | - | |||||||
Accounts receivable and accrued income from related parties | 5,500 | 4,129 | |||||||
Inventories | - | 474 | |||||||
Prepaid expenses | 996 | 690 | |||||||
Other current assets | 1,274 | 1,194 | |||||||
Total current assets | 143,946 | 228,113 | |||||||
Non-current assets | |||||||||
Property, plant and equipment, net | 35,702 | 26,011 | |||||||
Intangible assets, net | 8,324 | 6,815 | |||||||
Goodwill | 465 | 481 | |||||||
Other non-current assets | 1,828 | 1,243 | |||||||
Total non-current assets | 46,319 | 34,550 | |||||||
Total assets | $ | 190,265 | $ | 262,663 | |||||
Current liabilities | |||||||||
Accounts payable | $ | 5,524 | $ | 4,059 | |||||
Accrued expenses and other current liabilities | 9,766 | 9,863 | |||||||
Current portion of long-term debt | 605 | 5,579 | |||||||
Current portion of deferred rent | 684 | 630 | |||||||
Current portion of deferred revenue | 6,142 | 6,778 | |||||||
Total current liabilities | 22,721 | 26,909 | |||||||
Non-current liabilities | |||||||||
Long-term debt, net of current portion | 19,631 | 14,631 | |||||||
Deferred rent, net of current portion | 6,781 | 6,247 | |||||||
Deferred revenue, net of current portion | 75,612 | 83,445 | |||||||
Contingent consideration | 1,838 | 2,926 | |||||||
Other non-current liabilities | 51 | 578 | |||||||
Total non-current liabilities | 103,913 | 107,827 | |||||||
Total liabilities | 126,634 | 134,736 | |||||||
Commitments and contingencies | |||||||||
Shareholders' equity | |||||||||
Ordinary shares, €0.05 par value: 60,000,000 shares authorized at December 31, 2016 and 2015 and 25,257,420 and 24,327,944 shares issued and outstanding at December 31, 2016 and 2015, respectively. | 1,593 | 1,542 | |||||||
Additional paid-in-capital | 464,653 | 455,897 | |||||||
Accumulated other comprehensive loss | (6,557 | ) | (6,828 | ) | |||||
Accumulated deficit | (396,058 | ) | (322,684 | ) | |||||
Total shareholders' equity | 63,631 | 127,927 | |||||||
Total liabilities and shareholders' equity | $ | 190,265 | $ | 262,663 |
uniQure N.V. UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||
Years ended December 31, | |||||||||||||
2016 | 2015 | 2014 | |||||||||||
in thousands, except share and per share amounts | |||||||||||||
Total revenues | $ | 25,098 | 10,578 | 6,141 | |||||||||
Operating expenses: | |||||||||||||
Research and development expenses | (72,510 | ) | (59,125 | ) | (43,772 | ) | |||||||
Selling, general and administrative expenses | (25,999 | ) | (23,383 | ) | (17,073 | ) | |||||||
Total operating expenses | (98,509 | ) | (82,508 | ) | (60,845 | ) | |||||||
Other income | 1,465 | 779 | 1,022 | ||||||||||
Loss from operations | (71,946 | ) | (71,151 | ) | (53,682 | ) | |||||||
Non operating items, net | (283 | ) | (12,111 | ) | 3,370 | ||||||||
Loss before income tax benefit / (expense) | (72,229 | ) | (83,262 | ) | (50,312 | ) | |||||||
Income tax benefit / (expense) | (1,145 | ) | 1,179 | 535 | |||||||||
Net loss | $ | (73,374 | ) | $ | (82,083 | ) | $ | (49,777 | ) | ||||
Basic and diluted net loss per common share | $ | (2.93 | ) | $ | (3.72 | ) | $ | (2.91 | ) | ||||
Weighted average shares used in computing basic and diluted net loss per common share | 25,036,465 | 22,082,345 | 17,121,328 |
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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