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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% | 4.68 | 4.50 | 5.57 | 0 | 09:00:00 |
~ Strategic Review Completed to Refocus Pipeline, Reduce Operating Costs and Deliver Long-Term Shareholder Value
"With the completion of our company-wide strategic review, we have focused our pipeline, streamlined operations and improved our financial position," stated Matthew Kapusta, interim chief executive officer of uniQure. "Our near-term priorities are to aggressively prepare for a pivotal study in hemophilia B and to complete IND-enabling studies for our programs in Huntington's disease and congestive heart failure. We look forward to the presentation of updated Phase I/II data on AMT-060 in a couple of weeks at ASH, and discussing our late-stage development plans."
Recent Highlights
Financial Highlights for Q3 2016
Revenues for the three months ended September 30, 2016 were €6.5 million, compared with €3.1 million for the comparable period in 2015. The increase relates to increased research activity associated with S100A1 for heart failure, the expenses of which are fully reimbursed by BMS in accordance with the Company's collaboration agreement.
Research and development expenses were €15.3 million for the three months ended September 30, 2016, compared with €11.9 million for the comparable period in 2015. The increase is mainly due to increased activity in support of our collaboration agreement with BMS, validation and scale-up activities related to AMT-060 in the Company's Lexington facility, increased facility costs in Amsterdam and the continued progression of our clinical program for AMT-060 in hemophilia B and preclinical candidate AMT-130 in Huntington's disease.
Selling, general and administrative expenses were €4.1 million for the three months ended September 30, 2016, compared with €4.8 million for the comparable period in 2015. The decrease results from a reduction in professional fees and a reversal of share based payment expenses for unvested equity grants to our former CEO upon his resignation in September 2016, offset in part by expenses associated with the Glybera Phase IV study and global registry, which in prior years were capitalized.
Losses related to foreign currency effects on U.S. dollar-denominated deposits were €0.6 million for the three months ended September 30, 2016, compared to €1.6 million for the comparable period in 2015. Net finance costs were €0.2 million for the three months ended September 30, 2016, compared to a gain of €1.2 million for the comparable period in 2015.
The net loss for the third quarter 2016 was €13.5 million, or €0.54 per share, compared with €25.8 million, or €1.08 per share, for the third quarter of 2015.
As of September 30, 2016, the Company held cash and cash equivalents of €140.3 million and had 25,143,760 ordinary shares outstanding. Cash used in operating and investing activities in the third quarter of 2016 includes approximately €6.6 million of one-time capital expenditures related to the refurbishment of a new R&D facility in Amsterdam, the Netherlands. Excluding these one-time expenditures related to the new facility, cash used in operating and investing activities in the third quarter of 2016 would have been €18.0 million.
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 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, 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. 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:
Maria E. Cantor | Tom Malone |
Direct: 339-970-7536 | Direct: 339-970-7558 |
Mobile: 617-680-9452 | Mobile: 339-223-8541 |
m.cantor@uniQure.com | t.malone@uniQure.com |
Eva M. Mulder | |
Direct: +31 20 240 6103 | |
Mobile: +31 6 52 33 15 79 | |
e.mulder@uniQure.com |
UNIQURE N.V.Unaudited Condensed Consolidated Statements of Financial Position(€ in thousands)
December 31, | September 30, | |||||||
2015 | 2016 | |||||||
Assets | ||||||||
Non-current assets | ||||||||
Goodwill | 442 | 442 | ||||||
Intangible assets other than Goodwill | 7,209 | 8,771 | ||||||
Property, plant and equipment | 23,820 | 29,730 | ||||||
Other non-current assets | 1,142 | 1,663 | ||||||
Total non-current assets | 32,613 | 40,606 | ||||||
Current assets | ||||||||
Receivables from related parties | 3,792 | 3,591 | ||||||
Trade and other receivables | 1,730 | 6,142 | ||||||
Inventories | 435 | 70 | ||||||
Cash and cash equivalents | 203,532 | 140,331 | ||||||
Total current assets | 209,489 | 150,134 | ||||||
Total assets | 242,102 | 190,740 | ||||||
Equity | ||||||||
Share capital | 1,216 | 1,257 | ||||||
Share premium | 344,803 | 346,753 | ||||||
Other reserves | 26,026 | 30,361 | ||||||
Accumulated deficit | (252,561 | ) | (305,989 | ) | ||||
Total equity | 119,484 | 72,382 | ||||||
Liabilities | ||||||||
Non-current liabilities | ||||||||
Borrowings | 13,434 | 18,246 | ||||||
Derivative financial instruments - related party | 530 | 98 | ||||||
Deferred rent | 5,737 | 5,922 | ||||||
Deferred revenue | 75,852 | 72,335 | ||||||
Contingent consideration | 2,687 | 1,286 | ||||||
Total non-current liabilities | 98,240 | 97,887 | ||||||
Current liabilities | ||||||||
Trade and other payables | 11,220 | 11,678 | ||||||
Derivative financial instruments - related parties | 992 | 182 | ||||||
Borrowings | 5,124 | - | ||||||
Borrowings - derivative | 238 | 41 | ||||||
Deferred rent | 579 | 597 | ||||||
Deferred revenue | 6,225 | 5,573 | ||||||
Provisions | - | 2,400 | ||||||
Total current liabilities | 24,378 | 20,471 | ||||||
Total liabilities | 122,618 | 118,358 | ||||||
Total equity and liabilities | 242,102 | 190,740 |
UNIQURE N.V.Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss(€ in thousands except share and per share data)
Three months ended | Nine months ended | ||||||||||||||
September 30, | September 30, | ||||||||||||||
2015 | 2016 | 2015 | 2016 | ||||||||||||
License revenues | 1,041 | 1,100 | 1,754 | 3,302 | |||||||||||
Collaboration revenues | 1,809 | 5,366 | 3,818 | 11,007 | |||||||||||
Product sales | 300 | - | 300 | - | |||||||||||
Total revenues | 3,150 | 6,466 | 5,872 | 14,309 | |||||||||||
Cost of goods sold | (428 | ) | (75 | ) | (428 | ) | (227 | ) | |||||||
Other income | 186 | 302 | 532 | 1,126 | |||||||||||
Research and development expenses | (11,933 | ) | (15,281 | ) | (32,652 | ) | (47,744 | ) | |||||||
Selling, general and administrative expenses | (4,835 | ) | (4,140 | ) | (13,503 | ) | (16,248 | ) | |||||||
Impairment of intangible assets | (11,640 | ) | - | (11,640 | ) | - | |||||||||
Other gains/(losses), net | (1,552 | ) | (623 | ) | (2,548 | ) | (5,002 | ) | |||||||
Total operating costs | (30,202 | ) | (19,817 | ) | (60,239 | ) | (68,095 | ) | |||||||
Operating loss | (27,052 | ) | (13,351 | ) | (54,367 | ) | (53,786 | ) | |||||||
Finance income | 5 | 280 | 70 | 1,864 | |||||||||||
Finance expense | 1,173 | (450 | ) | (3,102 | ) | (1,506 | ) | ||||||||
Finance income/(expense), net | 1,178 | (170 | ) | (3,032 | ) | 358 | |||||||||
Result before corporate income tax | (25,874 | ) | (13,521 | ) | (57,399 | ) | (53,428 | ) | |||||||
Corporate income taxes | 30 | - | 30 | - | |||||||||||
Net loss | (25,844 | ) | (13,521 | ) | (57,369 | ) | (53,428 | ) | |||||||
Items that may be subsequently reclassified to profit or loss: | |||||||||||||||
Currency translation differences on foreign operations | (159 | ) | (132 | ) | 927 | (433 | ) | ||||||||
Other comprehensive income/(loss) | (159 | ) | (132 | ) | 927 | (433 | ) | ||||||||
Total comprehensive loss | (26,003 | ) | (13,653 | ) | (56,442 | ) | (53,861 | ) | |||||||
Loss per share attributable to the equity holders of the | |||||||||||||||
Company during the period: | |||||||||||||||
Basic and diluted loss per share | (1.08 | ) | (0.54 | ) | (2.69 | ) | (2.14 | ) |
UNIQURE N.V.Unaudited Condensed Consolidated Statements of Changes in Equity/Deficit(€ in thousands)
Share | Share | Other | Accumulated | Total | ||||||||||||||
capital | premium | reserves | deficit | equity | ||||||||||||||
Balance at January 1, 2015 | 905 | 206,111 | 17,149 | (181,081 | ) | 43,084 | ||||||||||||
Loss for the period | - | - | - | (57,369 | ) | (57,369 | ) | |||||||||||
Other comprehensive income/(loss) | - | - | 927 | - | 927 | |||||||||||||
Total comprehensive income/(loss) | - | - | 927 | (57,369 | ) | (56,442 | ) | |||||||||||
Capital contributions | 306 | 138,877 | - | - | 139,183 | |||||||||||||
Share issuance costs | - | (612 | ) | - | - | (612 | ) | |||||||||||
Share based payment expense | - | - | 5,242 | - | 5,242 | |||||||||||||
Balance at September 30, 2015 | 1,211 | 344,376 | 23,318 | (238,450 | ) | 130,455 | ||||||||||||
Loss for the period | - | - | - | (14,111 | ) | (14,111 | ) | |||||||||||
Other comprehensive income/(loss) | - | - | 323 | - | 323 | |||||||||||||
Total comprehensive income/(loss) | - | - | 323 | (14,111 | ) | (13,788 | ) | |||||||||||
Capital contributions | 5 | 427 | - | - | 432 | |||||||||||||
Share based payment expense | - | - | 2,385 | - | 2,385 | |||||||||||||
Balance at December 31, 2015 | 1,216 | 344,803 | 26,026 | (252,561 | ) | 119,484 | ||||||||||||
Loss for the period | - | - | - | (53,428 | ) | (53,428 | ) | |||||||||||
Other comprehensive income/(loss) | - | - | (433 | ) | - | (433 | ) | |||||||||||
Total comprehensive income/(loss) | - | - | (433 | ) | (53,428 | ) | (53,861 | ) | ||||||||||
Capital contributions | 41 | 1,950 | - | - | 1,991 | |||||||||||||
Share based payment expense | - | - | 4,768 | - | 4,768 | |||||||||||||
Balance at September 30, 2016 | 1,257 | 346,753 | 30,361 | (305,989 | ) | 72,382 |
UNIQURE N.V.Unaudited Condensed Consolidated Statements of Cash Flows(€ in thousands)
Nine months ended | |||||||
September 30, | |||||||
2015 | 2016 | ||||||
Cash flow from operating activities | |||||||
Net loss | (57,369 | ) | (53,428 | ) | |||
Adjustments for: | |||||||
Amortization on intangible assets | 274 | 600 | |||||
Impairment of intangible assets | 11,640 | - | |||||
Depreciation | 2,872 | 3,718 | |||||
Lease incentive | 129 | (607 | ) | ||||
Loss/(gain) on derivatives | 164 | (1,439 | ) | ||||
Loss/(gain) on foreign exchanges | 3,160 | 1,829 | |||||
Share-based payment expenses | 5,242 | 4,768 | |||||
Changes in provisions | - | 2,400 | |||||
Changes in trade and other receivables | (3,339 | ) | (4,211 | ) | |||
Changes in inventories | (210 | ) | 365 | ||||
Changes in other current liabilities | 1,933 | 429 | |||||
Changes in deferred revenue | 65,407 | (4,169 | ) | ||||
Cash generated from/(used in) operations | 29,903 | (49,745 | ) | ||||
Interest paid | (1,404 | ) | (1,434 | ) | |||
Net cash generated from/(used in) operating activities | 28,499 | (51,179 | ) | ||||
Cash used in investing activities | |||||||
Purchases of property, plant and equipment | (3,289 | ) | (9,502 | ) | |||
Purchases of intangible assets | (2,908 | ) | (1,716 | ) | |||
Changes in restricted cash | - | (555 | ) | ||||
Interest received | 70 | 61 | |||||
Net cash used in investing activities | (6,127 | ) | (11,712 | ) | |||
Cash flow from financing activities | |||||||
Proceeds from shares issued | 137,297 | 1,982 | |||||
Payments of finance lease | (125 | ) | (134 | ) | |||
Net cash generated from financing activities | 137,172 | 1,848 | |||||
Net increase/(decrease) in cash and cash equivalents | 159,544 | (61,043 | ) | ||||
Currency effect cash and cash equivalents | 1,731 | (2,158 | ) | ||||
Cash and cash equivalents at January 1 | 53,219 | 203,532 | |||||
Cash and cash equivalents at September 30 | 214,494 | 140,331 |
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/3df3f4cc-f25b-4687-9b5f-4d5bf1d9559d
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