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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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 4.69 | 4.50 | 5.57 | 0 | 09:00:00 |
"In the second quarter of 2019, we continued to make substantial progress across our pipeline. Patient enrollment in our ongoing Phase III HOPE-B pivotal study of AMT-061 continues to advance, and we remain on track to complete patient enrollment by the end of this year,” stated Matt Kapusta, chief executive of uniQure. “We are particularly encouraged by the Phase IIb data on AMT-061 and the long-term Phase I/II data on our first-generation AMT-060 presented earlier this month, which we believe demonstrate the potential of AMT-061 to provide durable increases of FIX activity into the normal range for people living with hemophilia B. In addition, significant efforts and progress have been made to initiate our Phase I/II study of AMT-130 in Huntington’s disease. There is considerable patient and investigator enthusiasm for a potential one-time administered treatment of this devastating disease, and we look forward to our planned initiation of patient dosing in this landmark study this year.”
Recent Company Progress
Upcoming Investor Events
Financial Highlights
Cash Position: As of June 30, 2019, the Company held cash and cash equivalents of $184.1 million, compared to $208.8 million as of March 31, 2019. The Company currently expects cash and cash equivalents will be sufficient to fund operations into 2021.
Revenues: Revenue for the three months ended June 30, 2019 was $2.5 million, compared to $3.1 million during the same period 2018. The decrease reflects the October 2018 termination of the development of S100A1 under our collaboration with Bristol-Myers Squibb.
R&D Expenses: Research and development expenses were $24.2 million for the three months ended June 30, 2019, compared to $18.5 million during the same period 2018. The change was primarily related to increased activities associated with our ongoing clinical studies of AMT-061, the planned Phase I/II study of AMT-130, increased share-based compensation and the hiring of additional clinical and operations staff at our Lexington site.
SG&A Expenses: Selling, general and administrative expenses were $7.9 million for three months ended June 30, 2019, compared to $5.9 million during the same period 2018. The change was primarily related to increases in personnel and consulting expenses, professional fees and share-based compensation expenses.
Net Loss: The net loss for the three months ended June 30, 2019 was $31.4 million, or $0.83 per share, compared to $20.6 million, or $0.57 per share during the same period 2018.
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 gene therapies to treat patients with hemophilia B, hemophilia A, Huntington's disease, Fabry disease, spinocerebellar ataxia Type 3 and other diseases. www.uniQure.com
uniQure Forward-Looking StatementsThis 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 achievement of any of our planned near term or other milestones, our ability to provide further clinical updates on the Phase IIb study in 2019 or at any time, our ability to complete enrollment in our pivotal Phase III trial of AMT-061 this year or ever, the ability of AMT-061 to provide durable increases of FIX activity into the normal range for people living with hemophilia B, the risk of cessation, delay or lack of success of any of our ongoing or planned clinical studies, our ability to initiate dosing of a Phase I/II study of AMT-130 this year or ever, our ability to open additional clinical sites for the Phase I/II study in the United States, and whether AMT-190 becomes a one-time treatment option, improves upon the enzyme replacement standard of care, has more efficient uptake in the kidney and heart, or has an improved immunogenicity profile. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities, clinical results, collaboration arrangements, 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 April 29, 2019. 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.canto@uniQure.com | e.mulder@uniQure.com | t.malone@uniQure.com |
uniQure N.V.
UNAUDITED CONSOLIDATED BALANCE SHEETS
June 30, | December 31, | ||||
2019 | 2018 | ||||
in thousands | |||||
Current assets | |||||
Cash and cash equivalents | $ | 184,095 | $ | 234,898 | |
Accounts receivable and accrued income from related party | 355 | 233 | |||
Prepaid expenses | 3,511 | 1,116 | |||
Other current assets | 580 | 329 | |||
Total current assets | 188,541 | 236,576 | |||
Non-current assets | |||||
Property, plant and equipment, net of accumulated depreciation of $25.8 million as of June 30, 2019, and $22.9 million as of December 31, 2018, respectively. | 28,057 | 29,179 | |||
Operating lease right-of-use assets | 27,173 | - | |||
Intangible assets, net | 5,864 | 5,201 | |||
Goodwill | 503 | 506 | |||
Restricted cash | 2,940 | 2,444 | |||
Total non-current assets | 64,537 | 37,330 | |||
Total assets | $ | 253,078 | $ | 273,906 | |
Current liabilities | |||||
Accounts payable | $ | 4,523 | $ | 3,792 | |
Accrued expenses and other current liabilities | 7,366 | 8,232 | |||
Current portion of operating lease liabilities | 4,256 | - | |||
Current portion of deferred rent | - | 311 | |||
Current portion of deferred revenue | 7,223 | 7,634 | |||
Total current liabilities | 23,368 | 19,969 | |||
Non-current liabilities | |||||
Long-term debt | 35,784 | 35,471 | |||
Operating lease liabilities, net of current portion | 31,870 | - | |||
Deferred rent, net of current portion | - | 8,761 | |||
Deferred revenue, net of current portion | 26,354 | 28,861 | |||
Derivative financial instruments related party | 3,251 | 803 | |||
Other non-current liabilities | 395 | 435 | |||
Total non-current liabilities | 97,654 | 74,331 | |||
Total liabilities | $ | 121,022 | $ | 94,300 | |
Total shareholders' equity | 132,056 | 179,606 | |||
Total liabilities and shareholders' equity | $ | 253,078 | $ | 273,906 | |
uniQure N.V.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
Three months ended June 30, | |||||||
2019 | 2018 | ||||||
in thousands, except share and per share amounts | |||||||
Total revenues | $ | 2,474 | $ | 3,050 | |||
Operating expenses: | |||||||
Research and development expenses | (24,154 | ) | (18,493 | ) | |||
Selling, general and administrative expenses | (7,870 | ) | (5,896 | ) | |||
Total operating expenses | (32,024 | ) | (24,389 | ) | |||
Other income | 566 | 565 | |||||
Other expense | (347 | ) | (429 | ) | |||
Loss from operations | (29,331 | ) | (21,203 | ) | |||
Non operating items, net | (2,068 | ) | 972 | ||||
Loss before income tax expense | (31,399 | ) | (20,231 | ) | |||
Income tax expense | - | (361 | ) | ||||
Net loss | $ | (31,399 | ) | $ | (20,592 | ) | |
Basic and diluted net loss per ordinary share | $ | (0.83 | ) | $ | (0.57 | ) | |
Weighted average shares used in computing basic and diluted net loss per ordinary share | 37,824,928 | 36,205,061 | |||||
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