AMSTERDAM, the Netherlands, Sept. 2, 2014 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced results for the second quarter of 2014 and an update on multiple gene therapy programs.
Corporate Highlights
Pipeline Program Updates
Glybera Updates
Jörn Aldag, uniQure Chief Executive Officer, commented: "uniQure is steadily executing its strategy of building a valuable clinical and pre-clinical pipeline from its gene therapy platform. We made major progress toward the achievement of preclinical, clinical, and corporate development goals, which we view to be essential to maintain our position at the forefront of gene therapy. In the second half of the year, we are focused on the start of the hemophilia B clinical trial."
Financial Highlights
As of June 30, 2014, the Company held cash and cash equivalents of €72.1 million. The numbers for the six months ended June 30, 2013 as presented below, have been restated; for further information please see the financial statements appearing at the end of this release.
Licensing and collaboration revenues for the three months ended June 30, 2014 were €1.0 million, compared with €0.8 million in the same period of 2013. For the six months ended June 30, 2014, total revenue was €2.2 million, compared to €0.8 million in the first six months in 2013. Collaboration revenues represent development activities that are reimbursable by Chiesi under the Company's co-development agreement for hemophilia B. License revenues represent the monthly amortization of the upfront payments received under the Chiesi agreements entered into in June 2013.
Research and development expenses were €8.0 million for the three months ended June 30, 2014, compared to a restated €2.9 million for the same period in 2013. Research and development expenses for the six months ended June 30, 2014 are €14.2 million compared to €6.4 million for the same period in 2013. The increase reflected the expansion of research and development activities to support the further development of the hemophilia B program, the further development of other pipeline product candidates, as well as the company's efforts to maintain its leadership position in the gene therapy field. The amount of research and development expenses is shown net of charges that were capitalized in relation to the development of the Company's approved product, Glybera.
Net loss for the three months ended June 30, 2014 was €9.0 million or €0.51 per share, compared to €7.8 million or €0.80 per share for the same period in 2013. Net loss for the six months ended June 30, 2014 was €16.8 million or €1.03 per share, compared to €13.0 million or €1.33 per share for the same period in 2013.
In the three months ended June 30, 2014 the Company signed an amended and restated loan agreement with Hercules Technology Growth Capital Inc. to increase its existing venture debt facility to $20.0 million (€14.6 million) and in May 2014 the Company rolled out the 2014 Option Plan granting a total of 926,000 options to staff and affiliates, with an exercise price of $9.35.
For further financial information for the period ending June 30, 2014, please refer to the financial statements appearing at the end of this release.
About uniQure
uniQure is delivering on the promise of gene therapy through single treatments with potentially curative results. We have developed a modular platform to rapidly bring new disease-modifying therapies to patients with severe disorders. We are engaged in multiple partnerships and have obtained regulatory approval of our lead product, Glybera, in the European Union for a subset of patients with LPLD. www.uniQure.com
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 commercial launch of Glybera in the EU, the risk of cessation or delay of any of the ongoing or planned clinical studies and/or development of our product candidates, the risk of delay or failure to successfully commercialize or obtain further regulatory approval of our products, and the risk that our collaborations or our other collaboration partners will not continue or will not be successful. 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, manufacturing processes and facilities regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors described under the heading "Risk Factors" in uniQure's Form 20-F filed with the Securities and Exchange Commission dated April 25, 2014. 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:
Aicha Diba
Investor Relations
Direct : +31 20 240 6100
Main: +31 20 566 7394
a.diba@uniQure.com
Media inquiries:
Gretchen Schweitzer
MacDougall Biomedical Communications
Direct: +49 172 861 8540
Main: +1 781 235 3060
gschweitzer@macbiocom.com
UNIQURE N.V.
Unaudited Condensed Consolidated Balance Sheets
(€ in thousands)
DECEMBER 31, 2013 |
JUNE 30, 2014 | ||||||
Assets | |||||||
Non-current assets | |||||||
Intangible assets | 7,775 | 9,728 | |||||
Property, plant and equipment | 2,614 | 14,614 | |||||
Other non-current assets | 923 | 932 | |||||
Total non-current assets | 11,312 | 25,274 | |||||
Current assets | |||||||
Receivables from related parties | 1,425 | 1,453 | |||||
Trade and Other Receivables | 1,557 | 2,513 | |||||
Inventories | 865 | 427 | |||||
Cash and cash equivalents | 23,810 | 72,057 | |||||
Total current assets | 27,657 | 76,450 | |||||
Total assets | 38,969 | 101,724 | |||||
Equity | |||||||
Share capital | 610 | 880 | |||||
Share premium | 142,459 | 204,142 | |||||
Other reserves | 6,536 | 11,162 | |||||
Accumulated deficit | (144,041 | ) | (160,872 | ) | |||
Total equity | 5,564 | 55,312 | |||||
Liabilities | |||||||
Non-current liabilities | |||||||
Borrowings | 6,292 | 14,498 | |||||
Financial lease liabilities | 302 | 219 | |||||
Deferred rent | 680 | 5,247 | |||||
Deferred revenue | 15,679 | 15,238 | |||||
Total non-current liabilities | 22,953 | 35,202 | |||||
Current liabilities | |||||||
Trade and other payables | 7,601 | 9,178 | |||||
Debt to related party - derivative | 722 | 516 | |||||
Borrowings | 633 | - | |||||
Borrowings - derivative | 217 | 170 | |||||
Deferred rent | - | 3 | |||||
Deferred revenue | 1,279 | 1,343 | |||||
Total Current Liabilities | 10,452 | 11,210 | |||||
Total liabilities | 33,405 | 46,412 | |||||
Total equity and liabilities | 38,969 | 101,724 |
UNIQURE N.V.
Unaudited Condensed Consolidated Statements of Comprehensive Loss
(€ in thousands, except share and per share data)
THREE MONTHS ENDED JUNE 30, |
SIX MONTHS ENDED JUNE 30, |
||||||||||
2013 (as restated) |
2014 |
2013 (as restated |
2014 | ||||||||
License revenues | - | 221 | - | 441 | |||||||
Collaboration revenues | 758 | 821 | 758 | 1,771 | |||||||
Total revenues | 758 | 1,042 | 758 | 2,212 | |||||||
Cost of goods sold | (800 | ) | - | (800 | ) | - | |||||
Other income | 203 | 152 | 391 | 390 | |||||||
Research and development expenses | (2,852 | ) | (8,008 | ) | (6,421 | ) | (14,226 | ) | |||
Selling, general and administrative expenses | (2,437 | ) | (2,548 | ) | (4,157 | ) | (4,817 | ) | |||
Other gains / losses, net | 26 | 583 | 35 | 64 | |||||||
Total Operating Costs | (5,060 | ) | (9,821 | ) | (10,152 | ) | (18,589 | ) | |||
Operating result | (5,102 | ) | (8,779 | ) | (10,194 | ) | (16,377 | ) | |||
Finance income | - | 44 | 44 | 71 | |||||||
Finance expense | (2,682 | ) | (255 | ) | (2,814 | ) | (514 | ) | |||
Finance income/(expense)-net | (2,682 | ) | (211 | ) | (2,770 | ) | (443 | ) | |||
Result before corporate income taxes | (7,784 | ) | (8,990 | ) | (12,964 | ) | (16,820 | ) | |||
Corporate income taxes | - | - | - | - | |||||||
Net Loss | (7,784 | ) | (8,990 | ) | (12,964 | ) | (16,820 | ) | |||
Items that may be subsequently reclassified to profit or loss | - | (11 | ) | - | (10 | ) | |||||
Other comprehensive income | - | - | - | (10 | ) | ||||||
Total comprehensive loss* | (7,784 | ) | (9,001 | ) | (12,964 | ) | (16,830 | ) | |||
Loss per share attributable to the equity holders of the Company during the year | |||||||||||
Basic and diluted loss per share | (0.80 | ) | (0.51 | ) | (1.33 | ) | (1.03 | ) |
* Total comprehensive loss is fully attributable to equity holders of the group
UNIQURE N.V.
Unaudited Condensed Consolidated Statement of Changes in Equity/Deficit
(€ in thousands)
TOTAL SHARE CAPITAL |
SHARE PREMIUM |
OTHER RESERVES |
ACCUMULATED DEFICIT |
TOTAL EQUITY/DEFICIT |
|||||||||
Balance at January 1, 2013 | 483 | 114,795 | 1,508 | (117,234 | ) | (448 | ) | ||||||
Result for the period | (12,964 | ) | (12,964 | ) | |||||||||
Capital contributions | 4 | 274 | 278 | ||||||||||
Share based payment/expense |
947 | 947 | |||||||||||
Balance at June 30, 2013 (as restated) |
487 | 115,069 | 2,455 | (130,198 | ) | (12,187 | ) | ||||||
Result for the period | (13,856 | ) | (13,856 | ) | |||||||||
Other Comprehensive Income |
13 | 13 | |||||||||||
Capital contributions | 123 | 27,390 | 27,513 | ||||||||||
Result on conversion of the Loan |
3,005 | 3,005 | |||||||||||
Share-based payment/expense |
1,076 | 1,076 | |||||||||||
Balance at December 31, 2013 |
610 | 142,459 | 6,536 | (144,041 | ) | 5,564 | |||||||
Result for the period | (16,820 | ) | (16,820 | ) | |||||||||
Other Comprehensive Income |
(10 | ) | (10 | ) | |||||||||
Proceeds from shares issued | 270 | 62,351 | 62,621 | ||||||||||
Share issuance cost | (668 | ) | (668 | ) | |||||||||
Share-based payment/expense |
4,626 | 4,626 | |||||||||||
Balance at June 30, 2014 | 880 | 204,142 | 11,162 | (160,872 | ) | 55,312 |
UNIQURE N.V.
Unaudited Condensed Consolidated Statement of Cash Flows
(€ in thousands)
SIX MONTHS ENDED JUNE 30, |
|||||||
2013 (as restated) | 2014 | ||||||
Cash flow from operating activities | |||||||
Result before corporate income tax | (12,964 | ) | (16,820 | ) | |||
Adjustments for: | |||||||
-Depreciation | 259 | 310 | |||||
-Lease Incentive | - | 3,876 | |||||
-Derivative result | 1,954 | (253 | ) | ||||
-Exchange result | (35 | ) | (64 | ) | |||
-Other non-cash items | 800 | (9 | ) | ||||
-Share-based payment expenses | 947 | 4,626 | |||||
-Changes in other non-current assets | - | - | |||||
-Changes in trade and other receivables | (17,845 | ) | (292 | ) | |||
-Movement in inventories | (188 | ) | 438 | ||||
-Changes in trade and other payables | 97 | (1,240 | ) | ||||
-Changes in deferred revenue and provisions | 17,083 | (377 | ) | ||||
-Movement in other liabilities | 469 | 448 | |||||
-Interest (income)/expense | 613 | 650 | |||||
Cash used in operations | (8,810 | ) | (8,707 | ) | |||
Interest paid | (6 | ) | (461 | ) | |||
Net cash used in operating activities | (8,816 | ) | (9,168 | ) | |||
Cash flow from investing activities | |||||||
Purchases of property, plant and equipment | (324 | ) | (9,787 | ) | |||
Purchases of intangible assets | (1,225 | ) | (1,953 | ) | |||
Interest received | - | 59 | |||||
Net cash used in investing activities | (1,549 | ) | (11,681 | ) | |||
Cash flow from financing activities | |||||||
Capital contribution from shareholders | 278 | ||||||
Proceeds from shares issued | - | 62,621 | |||||
Share issuance cost | - | (668 | ) | ||||
Convertible loans drawn down | 11,999 | - | |||||
Exchange result on Borrowings | - | 46 | |||||
Proceeds from borrowings | 7,492 | 7,184 | |||||
Redemption of financial lease | (70 | ) | (77 | ) | |||
Repayments of borrowings | - | - | |||||
Net cash generated from financing activities | 19,699 | 69,106 | |||||
Net increase in cash, cash equivalents, and other bank overdrafts | 9,334 | 48,257 | |||||
Currency effect cash and cash equivalents | - | (10 | ) | ||||
Cash, cash equivalents, and other bank overdrafts at beginning of the period |
263 | 23,810 | |||||
Cash, cash equivalents, and other bank overdrafts cash at end of the period |
9,597 | 72,057 |
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