Full Press Release Details
Index to Unaudited Condensed Consolidated Financial Statements
| PAGE | |
| Unaudited Condensed Consolidated Balance Sheets as of December 31, 2013 and June 30, 2014 | F-2 |
| Unaudited Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended June 30, 2013 (as restated) and 2014 and the Six Months Ended June 30, 2013 (as restated) and 2014 | F-3 |
| Unaudited Condensed Consolidated Statements of Changes in Equity / Deficit for the Six Months Ended June 30, 2013 (as restated) and 2014 | F-4 |
| Unaudited Condensed Consolidated Statements of Cash Flow for the Full year 2013 (as restated) and the Six Months Ended June 30, 2014 | F-5 |
| Notes to Unaudited Condensed Consolidated Financial Statements | F-6 |
Unaudited Condensed Consolidated Balance Sheets
| NOTE | DECEMBER 31, 2013 | JUNE 30, 2014 | |||||
| Assets | |||||||
| Non-current assets | |||||||
| Intangible assets | 8 | 7,775 | 9,728 | ||||
| Property, plant and equipment | 7 | 2,614 | 14,614 | ||||
| Other non-current assets | 9 | 923 | 932 | ||||
| Total non-current assets | 11,312 | 25,274 | |||||
| Current assets | |||||||
| Receivables from related parties | 10 | 1,425 | 1,453 | ||||
| Trade and Other Receivables | 10 | 1,557 | 2,513 | ||||
| Inventories | 11 | 865 | 427 | ||||
| Cash and cash equivalents | 12 | 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 | 13 | 5,564 | 55,312 | ||||
| Liabilities | |||||||
| Non-current liabilities | |||||||
| Borrowings | 15 | 6,292 | 14,498 | ||||
| Financial lease liabilities | 23 | 302 | 219 | ||||
| Deferred rent | 23 | 680 | 5,247 | ||||
| Deferred revenue | 16 | 15,679 | 15,238 | ||||
| Total non-current liabilities | 22,953 | 35,202 | |||||
| Current liabilities | |||||||
| Trade and other payables | 14 | 7,601 | 9,178 | ||||
| Debt to related party - derivative | 15 | 722 | 516 | ||||
| Borrowings | 15 | 633 | |||||
| Borrowings - derivative | 15 | 217 | 170 | ||||
| Deferred rent | 23 | 3 | |||||
| Deferred revenue | 16 | 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 |
The notes are an integral part of these condensed consolidated financial statements.
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, | ||||||||||
| NOTE | 2013 (as restated) | 2014 | 2013 (as restated | 2014 | |||||||
| License revenues | 16 | 221 | 441 | ||||||||
| Collaboration revenues | 16 | 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 | 17 | (2,852 | ) | (8,008 | ) | (6,421 | ) | (14,226 | ) | ||
| Selling, general and administrative expenses | 18 | (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 | 19 | (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 | 21 | (0.80 | ) | (0.51 | ) | (1.33 | ) | (1.03 | ) |
* 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 | (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 | 13 | 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 | 13 | 880 | 204,142 | 11,162 | (160,872 | ) | 55,312 |
The notes are an integral part of these condensed consolidated financial statements.
Unaudited Condensed Consolidated Statement of Cash Flows
| SIX MONTHS ENDED JUNE 30, | |||||||
| NOTE | 2013 (as restated) | 2014 | |||||
| Cash flow from operating activities | |||||||
| Result before corporate income tax | (12,964 | ) | (16,820 | ) | |||
| Adjustments for: | |||||||
| Depreciation | 7 | 259 | 310 | ||||
| Lease Incentive | 3,876 | ||||||
| Derivative result | 3 | 1,954 | (253 | ) | |||
| Exchange result | (35 | ) | (64 | ) | |||
| Other non-cash items | 800 | (9 | ) | ||||
| Share-based payment expenses | 20 | 947 | 4,626 | ||||
| Changes in other non-current assets | |||||||
| Changes in trade and other receivables | (17,845 | ) | (292 | ) | |||
| Movement in inventories | 11 | (188 | ) | 438 | |||
| Changes in trade and other payables | 14 | 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 | 7 | (324 | ) | (9,787 | ) | ||
| Purchases of intangible assets | 8 | (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 | 13 | 278 | |||||
| Proceeds from shares issued | 13 | 62,621 | |||||
| Share issuance cost | 13 | (668 | ) | ||||
| Convertible loans drawn down | 15 | 11,999 | |||||
| Exchange result on Borrowings | 46 | ||||||
| Proceeds from borrowings | 15 | 7,492 | 7,184 | ||||
| Redemption of financial lease | 15 | (70 | ) | (77 | ) | ||
| Repayments of borrowings | 15 | ||||||
| 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 | 12 | 9,597 | 72,057 |
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 $91,800,000 ( 67,300,000) and net proceeds of $85,400,000 ( 62,600,000) after commissions but before expenses. At the time of the initial public offering all existing shareholders agreed to a 180 day lock-up that has expired on August 4, 2014.
The unaudited condensed consolidated financial statements were authorized for issue by the supervisory board on August 26, 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 International Financial Reporting Standards ( 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.
The Unaudited Condensed Consolidated Statements of Comprehensive Income for the Six Months Ended June 30, 2013 have been restated to correct certain errors in a number of line items that became apparent in subsequent reviews, which are described below. As a result of the adjustments listed below; the overall result for the six month period ending June 30, 2013, is a reduction of the comprehensive loss of 529,000 and a subsequent reduction of the basic and diluted loss per share of 0.06.
| SIX MONTHS ENDED JUNE 30 (unaudited) | |||||||
| As reported | As restated | ||||||
| ( in thousands, except per share data) | |||||||
| 2013 | 2013 | Adjustments | |||||
| License revenues | |||||||
| Collaboration revenues | 475 | 758 | 283 | ||||
| Total revenues | 475 | 758 | 283 | ||||
| Cost of goods sold | (800 | ) | (800 | ) | |||
| Other income | 474 | 391 | (83 | ) | |||
| Research and development expenses | (6,800 | ) | (6,421 | ) | 379 | ||
| Selling, general and administrative expenses | (4,394 | ) | (4,157 | ) | 237 | ||
| Other gains / losses, net | 35 | 35 | |||||
| Total Operating Costs | (10,685 | ) | (10,152 | ) | 533 | ||
| Operating result | (11,010 | ) | (10,194 | ) | 816 | ||
| Finance income | 44 | 44 | |||||
| Finance expense | (2,483 | ) | (2,814 | ) | (331 | ) | |
| Finance income/(expense) net | (2,483 | ) | (2,770 | ) | (287 | ) | |
| Result before corporate income taxes | (13,493 | ) | (12,964 | ) | 529 | ||
| Corporate income taxes | |||||||
| Net Loss | (13,493 | ) | (12,964 | ) | 529 | ||
| Items that may be subsequently reclassified to profit or loss | |||||||
| Other comprehensive income | |||||||
| Total comprehensive loss* | (13,493 | ) | (12,964 | ) | 529 | ||
| Loss per share attributable to the equity holders of the Company during the year | |||||||
| Basic and diluted loss per share | (1.39 | ) | (1.33 | ) | 0.06 |
The adjustment made to collaboration revenue for the amount of 283,000 relates to recharges of operating expenses that, as per the the agreements with Chiesi, were rechargeable to Chiesi for the period up to June 30, 2013, and that were not included in the earlier reported numbers. The
adjustment made to on the Other Income line of (83,000) reflected a different quarterly allocation of a government grant, where recognition of the Other Income is now based on the progress of the program. Changes in the operating expenses, for a total of 616,000, related to attributing expenses more accurately over the quarters for an amount of 304,000 and to revised calculations leading to a reduced expense of 312,000 on share based expenses reflecting forfeitures on non-vested options for staff that was no longer employed at June 30, 2013. This amount of 312,000 also effected the Other Reserves as presented in the consolidated statement of changes in Equity / Deficit. The adjustment made to finance expense line of (287,000) reflected the correction of an error in the calculation of the conversion right of the convertible loan.
| June 30, 2013 Consolidated Statement of | Total Share | Share | Other | Accumulated | Total Equity / | ||||||
| changes in Equity / Deficit | Capital | Premium | reserves | deficit | deficit | ||||||
| ( of thousands) | |||||||||||
| As reported | 487 | 115,069 | 2,767 | (130,727 | ) | (12,404 | ) | ||||
| As restated | 487 | 115,069 | 2,455 | (130,198 | ) | (12,187 | ) | ||||
| Adjustments | (312 | ) | 529 | 217 |
As a result of these cumulative adjustments, as of June 30, 2013, the accumulated deficit decreased by 529,000 and the total equity / deficit improved by 217,000.
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
The standard that could have a significant effect on the consolidated financial statements of the Company is IFRS 15 Revenue from contracts with customers . IFRS 15 is effective from January 1, 2017 with a retrospective effect. The Company has not early adopted IFRS 15 and has yet to assess its full impact. 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.
Since December 31, 2013, other than the departure of the Company s CFO in May 2014, there have been no changes in the Company s finance department, which is responsible for financial risk management, nor in the Company s financial risk management policies.
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 | ||||||
| Trade and other payables | 7,445 | ||||||||
| Total | 8,234 | 2,890 | 4,045 | ||||||
| At June 30, 2014 | |||||||||
| Borrowings (excl. finance lease liabilities) | 2,206 | 12,292 | |||||||
| Financial lease liabilities | 162 | 174 | 45 | ||||||
| Trade and other payables | 9,016 | ||||||||
| Total | 9,178 | 2,380 | 12,337 |
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 derivative (warrants) | 722 | 722 | |||||||
| Borrowings derivative (warrants) | 217 | 217 | |||||||
| 939 | 939 |
| LEVEL 1 | LEVEL 2 | LEVEL 3 | TOTAL | ||||||
| At June 30, 2014 | |||||||||
| Debt to related party derivative (warrants) | 516 | 516 | |||||||
| Borrowings derivative (warrants) | 170 | 170 | |||||||
| 686 | 686 |
| LEVEL 3 | |||
| Opening Balance at January 1, 2014 | 939 | ||
| Transfers to/(from) level 3 | (686 | ) | |
| Losses recognized in Profit and Loss during the six months ended June 30, 2014 | (253 | ) | |
| Closing balance at June 30, 2014 | |||
| Total losses for the period included in P&L for assets held at the end of the reporting period, under Finance expenses | 253 |
Group valuation processes
The fair value of the level 2 liabilities as of June 30, 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 June 30, 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 interim 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 June 30, 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 June 2014 | |||||||||||
| Opening net book amount | 413 | 1,285 | 321 | 595 | 2,614 | ||||||
| Additions | 11,767 | 282 | 261 | 12,310 | |||||||
| Depreciation charge | (74 | ) | (74 | ) | (162 | ) | (310 | ) | |||
| Closing net book amount | 339 | 13,052 | 529 | 694 | 14,614 | ||||||
| At June 30, 2014 | |||||||||||
| Cost | 1,264 | 13,052 | 3,417 | 1,643 | 19,376 | ||||||
| Accumulated depreciation | (925 | ) | (2,888 | ) | (949 | ) | (4,762 | ) | |||
| Net book amount | 339 | 13,052 | 529 | 694 | 14,614 |
Construction in Process ( CIP ) at June 30, 2014 relates to the continued build-out of the manufacturing facility in Lexington, Massachusetts.
Depreciation expense of 310,000 for the six months ended June 30, 2014 (six months ended June 30, 2013: 259,000) has been charged in research and development expense.
8. Intangible Assets
| INTANGIBLE ASSETS | |||
| ( in thousands) | |||
| Period ended June 30, 2014 | |||
| Opening net book amount | 7,775 | ||
| Additions | 1,953 | ||
| Reductions | |||
| Amortization charge | |||
| Closing net book amount | 9,728 | ||
| At June 30, 2014 | |||
| Cost | 9,728 | ||
| Accumulated amortization and impairment | |||
| Net book amount | 9,728 |
Additions to intangible assets for the six months ended June 30, 2014 include the continued capitalization of Glybera development expenses, in accordance with IAS 38, for a total amount of 1,807,000 compared with a restated 1,226,000 for the six months ended June 30, 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 1,542,000 for the six months ended June 30, 2013. The June 2013 addition related to the capitalization of sub-license amendments following the Chiesi transaction in June 2013.
9. Other Non-Current Assets
As of December 31, 2013 and June 30, 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 | JUNE 30, 2014 | ||||
| ( in thousands) | |||||
| Receivables from related parties | 1,425 | 1,453 | |||
| Other receivables | 764 | 1,187 | |||
| Prepaid Expenses | 391 | 656 | |||
| Social security and other taxes | 402 | 670 | |||
| Trade and other receivables | 2,982 | 3,966 |
The fair value of trade and other receivables approximates their carrying value. As of June 30, 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 June 30, 2014 relate to invoiced amounts to Chiesi of 1,430,000. 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 | JUNE 30, 2014 | ||||
| ( in thousands) | |||||
| Raw materials | 103 | 230 | |||
| Work in Process / Intermediate Products | 762 | 197 | |||
| Inventories | 865 | 427 |
Inventories as of June 30, 2014 were 427,000 (June 30, 2013: 188,000). The amount includes the raw materials that are capitalized in connection with the manufacturing of Glybera for commercial sale, which is expected to commence in the fourth quarter of 2014 / first quarter of 2015. 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.
The reduction in the inventories over the course of 2014 related to a number of batches, manufactured in 2013, that were in 2014 considered to be out of specifications and could not be put forward for commercial sale; the reduction was accordingly booked into research and development expenses.
12. Cash and Cash Equivalents
| DECEMBER 31, 2013 | JUNE 30, 2014 | ||||
| ( in thousands) | |||||
| Cash at bank and on hand | 23,810 | 72,057 |