AMSTERDAM, The Netherlands, March 26, 2014 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced unaudited results for the financial year ended December 31, 2013. As of December 31, 2013, the Company held cash and cash equivalents of €23.8 million.
Corporate Highlights
2013 represented an important year for uniQure, with a substantially strengthened financial position and encouraging advances in the Company's development programs. This was in advance of the successful completion in February 2014 of uniQure's IPO on NASDAQ, placing 5,400,000 shares at $17 per share, raising a total of gross $91.8 million (€67.3 million) and after commissions but before expenses a net of $85.4 million (€62.6 million).
The following key achievements were completed during 2013:
- Two collaboration agreements signed with Chiesi Farmaceutici S.p.A. (Chiesi), one for the commercialization in the EU and selected additional territories of Glybera® for LPLD and the second for the co-development and commercialization of uniQure's hemophilia B program in the EU and additional territories (uniQure retains full rights for both programs in North America, Japan and certain other territories)
- Investment by Chiesi of €14 million in new uniQure equity
- Initial development of a 55,000 square foot (5,100 m(2)) manufacturing facility in Lexington, Massachusetts, USA
- Additional 2013 financings that included the extension and conversion of a €13.5 million convertible loan facility and a new $10 million (€7.4 million) venture debt facility
- Advanced preparations to initiate a Phase 1/2 clinical study for hemophilia B with Chiesi
- Initiation by collaborator Institut Pasteur of a Phase 1/2 clinical study for Sanfilippo B Syndrome
- Announcement by collaborator UCSF together with the NIH of a Phase 1 clinical study in Parkinson's disease
- Completion of recruitment for a Phase 1 clinical study for acute intermittent porphyria with collaborator Digna Biotech
Commenting on these achievements, Jörn Aldag, uniQure Chief Executive Officer, said: "We have successfully transformed uniQure over the last 18 months into a leader in the field of gene therapy. The business is now well positioned to continue delivering on the promise of gene therapy through the commercial launch of our first product, Glybera, advance of our clinical pipeline, and continued progress with our research activities. We look forward to key events expected in the next several months, including full analysis of the long-term Glybera data, launch of Glybera in the EU and further progress for our pipeline."
Regarding webcast of company results and expectations, uniQure management will conduct biannual investor conference calls/webcasts, the first of which will occur mid-2014.
Financial Highlights
Licensing and collaboration revenues for the 12 months ended December 31, 2013 were €2.9 million, compared with zero revenues in 2012. The majority of 2013 revenues are related to development activities that were reimbursable by Chiesi under the Company's co-development agreement for hemophilia B.
Research and development expenses were €13.2 million for the 12 months ended December 31, 2013, compared to €10.2 million for the comparable period in 2012. The increase reflected the expansion of research and development activities to support the further development of the hemophilia B program as well as the further development of other pipeline product candidates. 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.
Selling, general and administrative expenses were €11.6 million for the 12 months ended December 31, 2013, compared to €4.6 million in 2012. The increase resulted principally from increased headcount in 2013 as the Company continued to ramp up operations following a strategic restructuring at the end of 2011 and increased commercial, legal and other advisory fees.
Net loss for the full year 2013 was €26.8 million or €2.48 per share, compared to €14.7 million or €1.70 per share for the full year 2012.
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 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 Glybera, and the risk that our collaborations with Chiesi 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, regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors described under the heading "Risk Factors" in uniQure's prospectus filed with the Securities and Exchange Commission dated February 5, 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 20 566 8014
Main: +31 20 566 7394
IR@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.
Consolidated Statements of Comprehensive Income
(€ in thousands, except share and per share data)
| Years Ended December 31 | |||||
| 2012 | 2013 (unaudited) | ||||
| License revenues | - | 440 | |||
| Collaboration revenues | - | 2,503 | |||
| Total revenues | - | 2,943 | |||
| Cost of goods sold | - | (800) | |||
| Gross profit | - | 2,143 | |||
| Other income | 649 | 585 | |||
| Research and development expenses | (10,231) | (13,182) | |||
| Selling, general and administrative expenses | (4,564) | (11,628) | |||
| Other losses, net | (45) | (453) | |||
| Total operating costs | (14,840) | (25,263) | |||
| Operating result | (14,191) | (22,535) | |||
| Finance income | 22 | 102 | |||
| Finance expense | (547) | (4,387) | |||
| Finance income/(expense)-net | (525) | (4,285) | |||
| Result before corporate income taxes | (14,716) | (26,820) | |||
| Corporate income taxes | - | - | |||
| Net loss | (14,716) | (26,820) | |||
| Other comprehensive income | - | 12 | |||
| Total comprehensive loss* | (14,716) | (26,808) | |||
| Loss per share attributable to the equity holders of the Company during the year | |||||
| Basic and diluted loss per share | (1.70) | (2.48) | |||
* Total comprehensive loss is fully attributable to equity holders of the group
UNIQURE N.V.
Consolidated Balance Sheets
(€ in thousands)
| As of December 31, | |||||
| 2012 | 2013 (unaudited) | ||||
| Assets | |||||
| Non-current assets | |||||
| Intangible assets | 3,278 | 7,775 | |||
| Property, plant and equipment | 1,185 | 2,614 | |||
| Other non-current assets | - | 923 | |||
| Total non-current assets | 4,463 | 11,312 | |||
| Current assets | |||||
| Receivables from related parties | 26 | 1,425 | |||
| Trade and other receivables | 815 | 1,557 | |||
| Inventories | - | 865 | |||
| Cash and cash equivalents | 263 | 23,810 | |||
| Total current assets | 1,104 | 27,657 | |||
| Total assets | 5,567 | 38,969 | |||
| Equity | |||||
| Share capital | 483 | 610 | |||
| Share premium | 114,795 | 142,459 | |||
| Other reserves | 1,508 | 6,536 | |||
| Accumulated deficit | (117,234) | (144,041) | |||
| Total equity | (448) | 5,564 | |||
| Liabilities | |||||
| Non-current liabilities | |||||
| Borrowings | - | 6,292 | |||
| Financial lease liabilities | 450 | 302 | |||
| Deferred rent | - | 680 | |||
| Deferred revenue | - | 15,679 | |||
| Total non-current liabilities | 450 | 22,953 | |||
| Current liabilities | |||||
| Trade and other payables | 4,067 | 7,601 | |||
| Debt to related party-financial liability | 1,366 | 633 | |||
| Debt to related party-embedded derivative | 132 | 722 | |||
| Borrowings-embedded derivative | - | 217 | |||
| Deferred revenue | - | 1,279 | |||
| Total current liabilities | 5,565 | 10,452 | |||
| Total liabilities | 6,015 | 33,405 | |||
| Total equity and liabilities | 5,567 | 38,969 | |||
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