LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Nov. 06, 2018 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the third quarter of 2018 and highlighted recent progress across its business.
"We achieved a number of important milestones so far this year, including the initiation of our global HOPE-B pivotal trial in hemophilia B, the dosing of three patients in our dose-confirmation study of AMT-061 and the finalization of our toxicology study for AMT-130 in Huntington’s disease,” stated Matt Kapusta, chief executive officer of uniQure. “In the new year, we look forward to commencing patient dosing in the treatment phase of our HOPE-B pivotal study, as well as initiating a first-in-human study in Huntington’s disease. We also are excited to host a Research & Development Day on November 19, 2018 featuring our newest gene therapy research programs and our recent progress advancing important new technologies.”
Recent Company Progress
Expected Near-Term Company Milestones
Financial Highlights
Cash Position: As of September 30, 2018, the Company held cash and cash equivalents of $239.5 million, compared to $159.4 million as of December 31, 2017. The Company currently expects cash and cash equivalents will be sufficient to fund operations into 2021.
Revenues: Revenue for the three months ended September 30, 2018 was $3.1 million, compared to $2.3 million for the comparable period in 2017.
R&D Expenses: Research and development expenses were $20.5 million for the three months ended September 30, 2018, compared to $20.1 million for the comparable period in 2017. The increase was primarily related to costs incurred preparing for the initiation of the AMT-061 pivotal study and continued IND-enabling nonclinical studies of AMT-130. Research and development expenses for the three months ended September 30, 2018, include a $5.4 million noncash impairment loss on an in-process research asset acquired in the 2014 acquisition of the InoCard business, as well as $3.8 million of noncash income from the full release of contingent consideration recorded in relation to that acquisition.
SG&A Expenses: Selling, general and administrative expenses were $5.9 million for the three months ended September 30, 2018, compared to $5.6 million for the comparable period in 2017.
Other income, net: Other income, net was an income of $0.1 million for the three months ended September 30, 2018, compared to an expense of $14.2 million for the comparable period in 2017. The decrease was primarily related to income of $13.8 million recorded in 2017 from the July 2017 termination of the collaboration with Chiesi.
Net Loss: The net loss was $22.0 million, or $0.59 per share, for the three months ended September 30, 2018, compared to $10.2 million, or $0.40 per share, for the comparable period in 2017.
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, the completion of our Phase IIb study or the confirmation of the dose in that study, the release of top-line clinical data, dosing patients with AMT-061 in our Phase III clinical trial in the first quarter of 2019, any replacement by BMS of the S100A1 therapeutic target or the continued collaboration by BMS on other therapeutic targets pursuant to our collaboration agreement, the filing of an Investigational New Drug (IND) application for AMT-130 by the end of this year or its acceptance by regulatory authorities, initiating a Huntington’s Disease clinical program or other program, trial or study that is the first-in-patient or that otherwise begins in 2019, the achievement of any of our planned near term or other milestones, 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 our and our collaborators’ clinical development activities, collaboration arrangements, corporate reorganizations and strategic shifts, 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 Annual Report on Form 10-K filed on March 14, 2018 and Quarterly Report on Form 10-Q filed on November 6, 2018. 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 Contacts:
FOR INVESTORS: | FOR MEDIA: | |
Maria E. Cantor | Eva M. Mulder | Tom Malone |
Direct: 339-970-7536 | Direct: +31 20 240 6103 | Direct: 339-970-7558 |
Mobile: 617-680-9452 | Mobile: +31 6 52 33 15 79 | Mobile: 339-223-8541 |
m.cantor@uniQure.com | e.mulder@uniQure.com | t.malone@uniQure.com |
uniQure N.V. | |||||
UNAUDITED CONSOLIDATED BALANCE SHEETS | |||||
September 30, | December 31, | ||||
2018 | 2017 | ||||
in thousands, except share and per share amounts | |||||
Current assets | |||||
Cash and cash equivalents | $ | 239,546 | $ | 159,371 | |
Accounts receivables and accrued income | 552 | 1,586 | |||
Prepaid assets and other current assets | 1,982 | 1,826 | |||
Total current assets | 242,080 | 162,783 | |||
Non-current assets | |||||
Property, plant and equipment, net | 30,802 | 34,281 | |||
Intangible assets and goodwill | 5,724 | 10,100 | |||
Restricted cash | 2,454 | 2,480 | |||
Total non-current assets | 38,980 | 46,861 | |||
Total assets | $ | 281,060 | $ | 209,644 | |
Current liabilities | |||||
Accounts payable | $ | 4,115 | $ | 2,908 | |
Accrued expenses and other current liabilities | 7,098 | 8,838 | |||
Current portion of long-term debt | 11,111 | 1,050 | |||
Current portion of deferred rent | 1,093 | 737 | |||
Current portion of deferred revenue | 8,594 | 4,613 | |||
Current portion of contingent consideration | 1,084 | ||||
Total current liabilities | 32,011 | 19,230 | |||
Non-current liabilities | |||||
Long-term debt, net of current portion | 9,597 | 19,741 | |||
Deferred rent, net of current portion | 8,156 | 9,114 | |||
Deferred revenue, net of current portion | 29,849 | 67,408 | |||
Contingent consideration, net of current portion | 2,880 | ||||
Derivative financial instruments related party | 1,085 | 1,298 | |||
Other non-current liabilities | 510 | 614 | |||
Total non-current liabilities | 49,197 | 101,055 | |||
Total liabilities | 81,208 | 120,285 | |||
Total shareholders' equity | 199,852 | 89,359 | |||
Total liabilities and shareholders' equity | $ | 281,060 | $ | 209,644 | |
uniQure N.V. | ||||||||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
Three months ended September 30, | ||||||||
2018 | 2017 | |||||||
in thousands, except share and per share amounts | ||||||||
Total revenues | $ | 3,148 | $ | 2,260 | ||||
Operating expenses: | ||||||||
Research and development expenses | (20,541 | ) | (20,103 | ) | ||||
Selling, general and administrative expenses | (5,898 | ) | (5,584 | ) | ||||
Total operating expenses | (26,439 | ) | (25,687 | ) | ||||
Other income | 557 | 14,413 | ||||||
Other expense | (490 | ) | (261 | ) | ||||
Loss from operations | (23,224 | ) | (9,275 | ) | ||||
Non operating items, net | 1,157 | (1,248 | ) | |||||
Loss before income tax expense | (22,067 | ) | (10,523 | ) | ||||
Income tax benefit | 32 | 278 | ||||||
Net loss | $ | (22,035 | ) | $ | (10,245 | ) | ||
Basic and diluted net loss per common share | $ | (0.59 | ) | $ | (0.40 | ) | ||
Weighted average shares used in computing basic and diluted net loss per common share | 37,247,193 | 25,632,642 | ||||||