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UNIQURE N.V. Index to Consolidated Financial Statements PAGE Unaudited Condensed Consolidated Balance Sheets as of

Key Takeaway: Index to Consolidated Financial Statements PAGE Unaudited Condensed Consolidated Balance Sheets as of December 31, 2013 and March 31, 2014 F-2 Unaudited Condensed Consolidated Statements of Comprehensive Income for the Three Months Ended March 31, 2013 and 2014 F-3 Unaudited

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Index to Consolidated Financial Statements
PAGE
Unaudited Condensed Consolidated Balance Sheets as of December 31, 2013 and March 31, 2014 F-2
Unaudited Condensed Consolidated Statements of Comprehensive Income for the Three Months Ended March 31, 2013 and 2014 F-3
Unaudited Condensed Consolidated Statements of Changes in Equity for the Three Months Ended March 31, 2013 and 2014 F-4
Unaudited Condensed Consolidated Statements of Cash Flow for the Three Months Ended March 31, 2013 and 2014 F-5
Notes to Unaudited Condensed Consolidated Financial Statements F-6
Unaudited Condensed Consolidated Balance Sheets
NOTE DECEMBER 31, 2013 MARCH 31, 2014
Assets
Non-current assets
Intangible assets 8 7,775 8,923
Property, plant and equipment 7 2,614 9,362
Other non-current assets 9 923 925
Total non-current assets 11,312 19,210
Current assets
Receivables from related parties 10 1,425 233
Trade and Other Receivables 10 1,557 3,069
Inventories 11 865 948
Cash and cash equivalents 12 23,810 77,532
Total current assets 27,657 81,782
Total assets 38,969 100,992
Equity
Share capital 610 880
Share premium 142,459 204,142
Other reserves 6,536 8,878
Accumulated deficit (144,041 ) (151,869 )
Total equity 13 5,564 62,031
Liabilities
Non-current liabilities
Borrowings 15 6,292 5,683
Financial lease liabilities 23 302 261
Deferred rent 23 680 3,534
Deferred revenue 16 15,679 15,458
Total non-current liabilities 22,953 24,936
Current liabilities
Trade and other payables 14 7,601 10,524
Debt to related party embedded derivative 15 722 713
Borrowings 15 633 1,285
Borrowings embedded derivative 15 217 216
Deferred revenue 16 1,279 1,287
Total Current Liabilities 10,452 14,025
Total liabilities 33,405 38,961
Total equity and liabilities 38,969 100,992
The notes are an integral part of these condensed consolidated financial statements.
Unaudited Condensed Consolidated Statements of Comprehensive Income
( in thousands, except share and per share data)
THREE MONTHS ENDED MARCH 31,
NOTE 2013 2014
License revenues 16 220
Collaboration revenues 16 950
Total revenues 1,170
Cost of goods sold
Other income 188 238
Research and development expenses 17 (3,568 ) (6,218 )
Selling, general and administrative expenses 18 (1,720 ) (2,268 )
Other gains / losses, net 9 (519 )
Total Operating Costs (5,091 ) (8,767 )
Operating result (5,091 ) (7,597 )
Finance income 44 27
Finance expense (132 ) (259 )
Finance income/(expense) net (88 ) (232 )
Result before corporate income taxes (5,179 ) (7,829 )
Corporate income taxes
Net Loss (5,179 ) (7,829 )
Items that may be subsequently reclassified to profit or loss 19 2
Other comprehensive income 2
Total comprehensive loss* (5,179 ) (7,827 )
Loss per share attributable to the equity holders of the Company during the year
Basic and diluted loss per share 21 (0.53 ) (0.52 )
* Total comprehensive loss is fully attributable to equity holders of the group
The notes are an integral part of these condensed consolidated financial statements.
Unaudited Condensed Consolidated Statement of Changes in Equity/Deficit
Note 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 (5,179 ) (5,179 )
Capital contributions 3 211 214
Share based payment/expense 542 542
Balance at March 31, 2013 486 115,006 2,050 (122,413 ) (4,871 )
Result for the period (21,640 ) (21,640 )
Other Comprehensive Income 12 12
Capital contributions 124 27,453 27,577
Result on conversion of the Loan 3,005 3,005
Share-based payment/expense 1,481 1,481
Balance at December 31, 2013 13 610 142,459 6,536 (144,041 ) 5,564
Result for the period (7,829 ) (7,829 )
Other Comprehensive Income 2 2
Proceeds from shares issued 270 62,351 62,621
Share issuance cost (668 ) (668 )
Share-based payment/expense 2,342 2,342
Balance at March 31, 2014 13 880 204,142 8,878 (151,869 ) 62,031
The notes are an integral part of these condensed consolidated financial statements.
Unaudited Condensed Consolidated Statement of Cash Flows
THREE MONTHS ENDED MARCH 31,
NOTE 2013 2014
Cash flow from operating activities
Result before corporate income tax (5,179 ) (7,829 )
Adjustments for:
Depreciation 7 116 144
Lease Incentive 2.854
Derivative result 3 (10 )
Exchange result (9 ) 7
Share-based payment expenses 20 542 2,342
Changes in other non-current assets
Changes in trade and other receivables 267 (320 )
Movement in inventories 11 (135 ) (83 )
Changes in trade and other payables 14 115 (1,062 )
Changes in deferred revenue and provisions 41 (213 )
Movement in other liabilities 346 (909 )
Interest (income)/expense 88 235
Cash used in operations (3,808 ) (4,844 )
Interest paid (225 )
Net cash used in operating activities (3,808 ) (5,069 )
Cash flow from investing activities
Purchases of property, plant and equipment 7 (40 ) (2,025 )
Purchases of intangible assets 8 (133 ) (1,148 )
Interest received 47
Net cash used in investing activities (173 ) (3,126 )
Cash flow from financing activities
Capital contribution from shareholders 13 214
Proceeds from shares issued 13 62,621
Share issuance cost 13 (668 )
Convertible loans drawn down 15 11,999
Proceeds from borrowings 15
Redemption of financial lease 15 (35 ) (38 )
Repayments of borrowings 15
Net cash generated from financing activities 12,178 61,915
Net increase in cash, cash equivalents, and other bank overdrafts 8,197 53,720
Currency effect cash and cash equivalents 2
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 12 8,460 77,532
The notes are an integral part of these condensed consolidated financial statements.
Notes to Unaudited Condensed Consolidated Financial Statements
1. General information
uniQure N.V. ( uniQure or the Company ) is a biopharmaceutical company domiciled in The Netherlands with headquarters at Meibergdreef 61, 1105 BA, Amsterdam, The Netherlands.
The Company is a leader in the field of gene therapy, and has developed the first product to receive regulatory approval in the European Union and as well as multiple collaborations designed to accelerate the development of a broad pipeline of additional product candidates. The Company was incorporated in January 2012 to acquire and continue the gene therapy business ( AMT Business ) of Amsterdam Molecular Therapeutics (AMT) Holding N.V. ( AMT ) and its subsidiaries (collectively, the AMT Group ) and to facilitate additional financing, as described further below. As used in these condensed consolidated interim financial statements, unless the context indicates otherwise, all references to uniQure or the Company refer to uniQure and its consolidated subsidiaries.
Organizational structure of the uniQure Group
uniQure N.V. is the ultimate parent of the following group of entities:
Company name
uniQure biopharma B.V.
uniQure IP B.V.
uniQure Manufacturing B.V.
uniQure Assay Development B.V.
uniQure Research B.V.
uniQure non clinical B.V.
uniQure QA B.V.
uniQure Process Development B.V.
uniQure clinical B.V.
Stichting participatie AMT(1)
uniQure Inc.(2)
(1) Stichting participatie AMT is a Trust, not a company, but met the conditions for consolidation within uniQure s consolidated financial statements. Stichting participatie AMT was established to facilitate AMT s employee incentive schemes for the period up to 2010.
(2) In May 2013 the Company incorporated uniQure Inc., a Delaware corporation and wholly owned subsidiary of uniQure biopharma B.V.
In January 2014, the Company entered into a collaboration and license agreement with 4D for the discovery and optimization of next-generation AAV vectors. Under this agreement, the Company has an exclusive license to 4D s existing and certain future know-how and other intellectual property for the delivery of AAV vectors to CNS or liver cells for the diagnosis, treatment, palliation or prevention of all diseases or medical conditions. Under this collaboration, the 4D team, including Dr. David Schaffer, 4D s co-founder and Professor of Chemical and Biomolecular Engineering at the University of California, Berkeley, will establish a laboratory, which the Company will fund, at a cost of approximately $3.0 million in aggregate over the next three years, to identify next generation AAV vectors. The Company is also required to make payments for pre-clinical, clinical and regulatory milestones under the collaboration as well as to pay single-digit royalties. In addition, the Company has granted options to purchase an aggregate of 609,744 ordinary shares in connection with this
collaboration, and will recognize resulting share-based payment expense over the next three years. To the extent that the collaboration is successful, the Company may also incur additional third party costs in developing any product candidates and also in preparing, filing and prosecuting additional patent applications
On January 20, 2014, the shareholders of the Company approved, and on January 21, 2014 the supervisory board of the Company confirmed, a 5-for-1 consolidation of shares, which had the effect of a reverse share split, that became effective on January 31, 2014. All share, per-share and related information presented in these unaudited condensed consolidated financial statements and accompanying footnotes has been retroactively adjusted, where applicable, to reflect the impact of the reverse share split.
On February 5, 2014 the Company successfully completed its initial public offering, placing 5,400,000 shares at $17 per share, raising total gross proceeds of $91.8 million ( 67.3 million) and net proceeds of $85.4 million ( 62.6 million) after commissions but before expenses. At the time of the initial public offering all existing shareholders agreed to a 180 day lock-up that will expire on August 4, 2014.
The unaudited condensed consolidated financial statements were authorized for issue by the supervisory board on May 27, 2014.
2. Summary of Significant Accounting Policies
2.1 Basis of Preparation
These unaudited condensed consolidated financial statements of the Company were prepared in accordance with International Accounting Standard 34, Interim Financial Reporting . Certain information and disclosures normally included in consolidated financial statements prepared in accordance with IFRS have been condensed or omitted. Accordingly, these condensed consolidated financial statements should be read in conjunction with the Company s annual consolidated financial statements for the year ended December 31, 2013 which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board. These consolidated financial statements for the year ended December 31, 2013 were filed with the SEC on April 25, 2014 as part of Form 20-F.
The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Company s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to these condensed consolidated financials are disclosed in Note 4.
2.2 Changes in Accounting Policy and Disclosures
The accounting policies adopted are consistent with those of the previous financial year, except as described below.
a) New and amended standards adopted by the Company
The following standards and amendments to standards became effective for annual periods on January 1, 2014 and have been adopted by the Company in the preparation of the condensed consolidated financial statements:
IFRS 10 Amended / Consolidated Financial Statements
IFRS 12 Amended / Disclosures of Interest in Other Entities
IAS 27 Amended / Consolidated and Separate Financial Statements
IAS 32 Amended / Financial Instruments: Presentation
IAS 36 Amended / Impairment of Assets
IAS 39 Amended / Financial Instruments: Recognition and Measurement
IFRIC 21 Levies
The adoption of these new standards and amendments did not materially impact the Company s financial position or results of operations.
b) New and amended standards not yet adopted by the Company
There are no standards which are currently available for early adoption which are expected to have a significant effect on the condensed consolidated financial statements of the Company.
3. Financial risk management
3.1 Financial risk factors
The Company s activities expose it to a variety of financial risks: market risk (including currency risk, fair value interest rate risk, cash flow interest rate risk and price risk), credit risk and liquidity risk.
The condensed consolidated financial statements do not include all financial risk management information and disclosures required in the annual consolidated financial statements, and should be read in conjunction with the Company s annual consolidated financial statements for the period ended December 31, 2013.
There have been no changes in the Company s finance department, which is responsible for financial risk management, or in the Company s financial risk management policies, since December 31, 2013.
The table below analyzes the Company s financial liabilities in relevant maturity groupings based on the length of time until the contractual maturity date, as at the balance sheet date. The amounts disclosed in the table are the contractual undiscounted cash flows. Balances due within 12 months equal their carrying value balances as the impact of discounting is not significant.
LESS THAN 1 YEAR BETWEEN 1 AND 2 YEARS BETWEEN 2 AND 5 YEARS OVER 5 YEARS
( in thousands)
At December 31, 2013
Borrowings (excl. finance lease liabilities) 633 2,722 3,911
Financial lease liabilities 156 168 134
Debt to related party
Trade and other payables 7,445
Total 8,234 2,890 4,045
At March 31, 2014
Borrowings (excl. finance lease liabilities) 1,285 2,805 2,878
Financial lease liabilities 159 171 90
Debt to related party
Trade and other payables 10,363
Total 11,807 2,976 2,968
For financial instruments that are measured on the balance sheet at fair value, IFRS 7 requires disclosure of fair value measurements by level of the following fair value measurement hierarchy:
Quoted prices (unadjusted) in active markets for identical assets or liabilities (level 1);
Inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices) (level 2); and
Inputs for the asset or liability that are not based on observable market data (that is, unobservable inputs) (level 3).
The fair value of financial instruments that are not traded in an active market (for example, over-the-counter derivatives) is determined by using valuation techniques. These valuation techniques maximize the use of observable market data where it is available and rely as little as possible on entity specific estimates. If all significant inputs required to ascertain the fair value of an instrument are observable, the instrument is included in level 2. If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3
Following the Initial Public Offering in February 2014, the measurement for the warrants is now a level 2 valuation, as our shares are traded on NASDAQ under the symbol QURE and the valuation of the warrants is derived from the quoted share price..
The carrying amount of a financial asset or financial liability is a reasonable approximation of the fair value and therefore information about the fair values of each class has not been disclosed.
LEVEL 1 LEVEL 2 LEVEL 3 TOTAL
At December 31, 2013
Debt to related party embedded derivative (warrants) 722 722
Borrowings embedded derivative (warrants) 217 217
939 939
LEVEL 1 LEVEL 2 LEVEL 3 TOTAL
At March 31, 2014
Debt to related party embedded derivative (warrants) 713 713
Borrowings embedded derivative (warrants) 216 216
929 929
LEVEL 3
Opening Balance at January 1, 2014 939
Transfers to/(from) level 3 (929 )
Losses recognized in Profit and Loss during the three months ended March 31, 2014 (10 )
Closing balance at March 31, 2014
Total losses for the period included in P&L for assets held at the end of the reporting period, under Finance expenses 10
Group valuation processes
The fair value of the level 2 liabilities as of March 31, 2014 has been determined using a Black-Scholes option pricing model. Key inputs include the risk-free rate, volatility, term, exercise price, and fair value of ordinary shares. The values are included within the tables presented above. Changes in the fair values are analyzed at each reporting date during the quarterly review process. The fair value of ordinary share is the quoted price as of March 31, 2014.
4. Critical Accounting Estimates and Judgments
The preparation of financial statements in conformity with IFRS requires the Company to make estimates and assumptions that affect the reported amounts and classifications of assets and liabilities, revenues and expenses
in the condensed consolidated financial statements. The estimates that have a significant risk of causing a material adjustment to the financial statements are utilized for share-based compensation, income taxes, research and development expenditures and borrowings. Actual results could differ materially from those estimates and assumptions.
The preparation of financial statements in conformity with IFRS also requires the Company to exercise judgment in applying the accounting policies. Critical judgments in the application of the Company s accounting policies relate to research and development expenditures, revenues and the cost of license revenues.
The condensed consolidated financial statements do not include all disclosures for critical accounting estimates and judgments that are required in the annual consolidated financial statements, and should be read in conjunction with the Company s annual consolidated financial statements for the period ended December 31, 2013.
The Company has not generated any revenues from royalties or product sales through March 31, 2014.
In July 2013, the Company received upfront payments in connection with the Glybera commercialization agreement and hemophilia B co- development agreements. Revenues from such non-refundable, up-front payments are initially reported as deferred revenues on the consolidated balance sheet and are recognized in revenues as earned over the period of the development, commercialization, collaboration or manufacturing obligation.
The Company also generates revenues from collaborative research and development arrangements. Such agreements may consist of multiple elements and provide for varying consideration terms, such as up-front, milestone and similar payments, which require significant analysis by management in order to determine the appropriate method of revenue recognition.
Where such arrangements can be divided into separate units of accounting (each unit constituting a separate earnings process), the arrangement consideration is allocated to the different units based on their relative fair values and recognized over the respective performance period. Where the arrangement cannot be divided into separate units, the individual deliverables are combined as a single unit of accounting and the total arrangement consideration is recognized over the estimated collaboration period. Such analysis requires considerable estimates and judgments to be made by us, including the relative fair values of the various elements included in such agreements and the estimated length of the respective performance periods.
Management has concluded that the up-front payments constitute a single unit of accounting, and accordingly, the up-front payments will be recognized over the estimated remaining period of the related manufacturing technologies.
5. Seasonality of Operations
The Company s financial results have varied substantially, and are expected to continue to vary, from quarter to quarter. The Company therefore believes that period-to-period comparisons should not be relied upon as indicative of future financial results. The Company believes that its ordinary activities are not linked to any particular seasonal factors.
6. Segment Information
Operating segments are identified on the basis of whether the allocation of resources and/or the assessment of performance of a particular component of uniQure s activities are regularly reviewed by uniQure s chief operating decision maker as a separate operating segment. By these criteria, the activities of uniQure are considered to be one segment, which comprises the discovery, development and commercialization of innovative gene therapies, and the segmental analysis is the same as the analysis for uniQure as a whole. The Management Board is the chief operating decision maker, and it reviews the consolidated operating results regularly to make decisions about the Company s resources, and to assess overall performance.
The Company currently, and in the near future, is expected to derive the substantial majority of its revenues from a single party, Chiesi, based in Italy. The Company and Chiesi have entered into an exclusive collaboration for
the development and commercialization of the Company s Glybera and Hemophilia B programs in Europe and certain additional territories, pursuant to agreements which were entered into in April 2013, and which became effective in June 2013.
7. Property, Plant and Equipment
LEASEHOLD IMPROVEMENTS CONSTRUCTION IN PROCESS LAB EQUIPMENT OFFICE EQUIPMENT TOTAL
( in thousands)
Period ended March 31, 2014
Opening net book amount 413 1,285 321 595 2,614
Additions 6.722 81 89 6,892
Depreciation charge (38 ) (34 ) (72 ) (144 )
Closing net book amount 375 8,007 368 612 9,362
At March 31, 2014
Cost 1,264 8,007 3,215 1,472 13,958
Accumulated depreciation (889 ) (2,847 ) (860 ) (4,596 )
Net book amount 375 8,007 368 612 9,362
Construction in Process ( CIP ) at March 31, 2014 relates to the continued build-out of the manufacturing facility in Lexington, Massachusetts.
Depreciation expense of 144,000 for the three months ended March 31, 2014 (three months ended March 31, 2013: 116,000) has been charged in research and development expense.
8. Intangible Assets
INTANGIBLE ASSETS
( in thousands)
Period ended March 31, 2014
Opening net book amount 7,775
Additions 1,148
Reductions
Amortization charge
Closing net book amount 8,923
At March 31, 2014
Cost 8,923
Accumulated amortization and impairment
Net book amount 8,923
Additions to intangible assets for the three months ended March 31, 2014 include the continued capitalization of Glybera development expenses, in accordance with IAS 38, for a total amount of 1,002,000 compared with 133,000 for the three months ended March 31, 2013. Capitalization of Glybera costs commenced on March 21, 2013 and had a balance of 3,108,000 as of December 31, 2013. Other additions relate to the capitalization of license amendment fees following the agreements entered into with 4D Molecular Therapeutics, for a total amount of 146,000 compared with nil for the three months ended March 31, 2013.
9. Other Non-Current Assets
As of December 31, 2013 and March 31, 2014, the amount represents a refundable security deposit for the Lexington, Massachusetts facility, paid in September 2013.
10. Trade and Other Receivables
DECEMBER 31, 2013 MARCH 31, 2014
( in thousands)
Receivables from related parties 1,425 233
Other receivables 764 2,047
Prepaid Expenses 391 652
Social security and other taxes 402 370
Trade and other receivables 2,982 3,302
The fair value of trade and other receivables approximates their carrying value. As of March 31, 2014 and December 31, 2013, all trade and other receivables were assessed as fully recoverable. The carrying amount of the Company s trade receivables are denominated in Euro and US Dollars.
The receivables from related parties as of March 31, 2014 relate to invoiced amounts to Chiesi based on our Commercialization and Co-development agreements of 210,000. The remaining element of receivables from related parties relate to certain wage tax liabilities settled by AMT on behalf of senior management in connection with purchases of AMT depositary receipts in 2007; these amounts are repayable to uniQure on sale of the related depositary receipts or on the respective employee ceasing to be employed by the Company of 23,000.
The other classes within trade and other receivables do not contain impaired assets. The maximum exposure to credit risk at the reporting date is the carrying value of each class of receivable mentioned above.
The other receivables primarily relate to prepaid rent, insurance and certain annual license fees for software and Intellectual Property.
DECEMBER 31, 2013 MARCH 31, 2014
( in thousands)
Raw materials 103 163
Work in Process / Intermediate Products 762 785
Inventories 865 948
Inventories as of March 31, 2014 were 948,000 (March 31,2013: nil). The amount includes the raw materials that are capitalized in connection with the manufacturing of Glybera for commercial sale, which is expected to commence mid-2014. Also included in inventories are amounts assigned to work in progress and intermediate products following the initial production batches of Glybera. Only Glybera-related material that could not be used for commercial purposes is expensed.
12. Cash and Cash Equivalents
DECEMBER 31, 2013 MARCH 31, 2014
( in thousands)
Cash at bank and on hand 23,810 77,532
The cash balance as of March 31, 2014 reflects the net receipt of 62.6 million related to the net proceeds from the Initial Public Offering in February 2014.
Supplemental information relating to the cash flow statement
Purchases of fixed assets and changes in trade and other payables exclude a non-cash item of 4,723,000 largely related to the purchase of fixed assets, which have not yet been paid as of March 31, 2014 (March 31, 2013: 190,000). Refer to Note 7 above.
Following a general meeting of shareholders of uniQure on July 22, 2013, the Company s authorized share capital was increased from 1,900,000 or 190,000,000 shares to 2,000,000 or 200,000,000 shares by the creation of a new sub-denomination of class C Ordinary Shares, on the following basis:
Last updated: Jun 6, 2014