Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 26, 2019 | Jun. 30, 2018 | |
Document and Entity Information | |||
Entity Registrant Name | uniQure N.V. | ||
Entity Central Index Key | 1,590,560 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 1,403.4 | ||
Entity Common Stock, Shares Outstanding | 37,626,300 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 234,898 | $ 159,371 |
Accounts receivable and accrued income from related party | 233 | 1,586 |
Prepaid expenses | 1,116 | 1,139 |
Other current assets | 329 | 687 |
Total current assets | 236,576 | 162,783 |
Non-current assets | ||
Property, plant and equipment, net | 29,179 | 34,281 |
Intangible assets, net | 5,201 | 9,570 |
Goodwill | 506 | 530 |
Restricted cash | 2,444 | 2,480 |
Total non-current assets | 37,330 | 46,861 |
Total assets | 273,906 | 209,644 |
Current liabilities | ||
Accounts payable | 3,792 | 2,908 |
Accrued expenses and other current liabilities | 8,232 | 8,838 |
Current portion of long-term debt | 1,050 | |
Current portion of deferred rent | 311 | 737 |
Current portion of deferred revenue | 7,634 | 4,613 |
Current portion of contingent consideration | 1,084 | |
Total current liabilities | 19,969 | 19,230 |
Non-current liabilities | ||
Long-term debt, net of current portion | 35,471 | 19,741 |
Deferred rent, net of current portion | 8,761 | 9,114 |
Deferred revenue, net of current portion | 28,861 | 67,408 |
Contingent consideration, net of current portion | 2,880 | |
Derivative financial instruments related party | 803 | 1,298 |
Other non-current liabilities | 435 | 614 |
Total non-current liabilities | 74,331 | 101,055 |
Total liabilities | 94,300 | 120,285 |
Commitments and contingencies (see note 16) | ||
Shareholders' equity | ||
Ordinary shares, €0.05 par value: 60,000,000 shares authorized at December 31, 2018 and December 31, 2017 and 37,351,653 and 31,339,040 ordinary shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively. | 2,299 | 1,947 |
Additional paid-in-capital | 720,072 | 566,530 |
Accumulated other comprehensive loss | (7,259) | (3,800) |
Accumulated deficit | (535,506) | (475,318) |
Total shareholders' equity | 179,606 | 89,359 |
Total liabilities and shareholders' equity | $ 273,906 | $ 209,644 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - € / shares | Dec. 31, 2018 | Dec. 31, 2017 |
CONSOLIDATED BALANCE SHEETS | ||
Ordinary shares, par value (in euros per share) | € 0.05 | € 0.05 |
Ordinary shares, authorized | 60,000,000 | 60,000,000 |
Ordinary shares, issued | 37,351,653 | 31,339,040 |
Ordinary shares, outstanding | 37,351,653 | 31,339,040 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Total | $ 11,284 | $ 13,107 | $ 25,098 |
Operating expenses: | |||
Research and development expenses | (74,809) | (72,172) | (72,510) |
Selling, general and administrative expenses | (25,305) | (24,635) | (25,999) |
Total operating expenses | (100,114) | (96,807) | (98,509) |
Other income | 2,146 | 15,430 | 1,465 |
Other expense | (1,548) | (3,073) | |
Loss from operations | (88,232) | (71,343) | (71,946) |
Interest income | 2,729 | 117 | 70 |
Interest expense | (2,160) | (2,232) | (2,172) |
Foreign currency gains / (losses), net | 4,382 | (3,566) | 1,034 |
Other non-operating (loss) / income, net | 208 | (2,435) | 785 |
Loss before income tax expense | (83,073) | (79,459) | (72,229) |
Income tax benefit / (expense) | (231) | 199 | (1,145) |
Net loss | (83,304) | (79,260) | (73,374) |
Other comprehensive (loss) / income, net of income tax: | |||
Foreign currency translation adjustments net of tax impact of $(0.2) million for the year ended December 31, 2018 (2017: $0.2 million and 2016: $(1.1) million) | (5,261) | 2,757 | 271 |
Total comprehensive loss | $ (88,565) | $ (76,503) | $ (73,103) |
Basic and diluted net loss per ordinary share | $ (2.34) | $ (2.94) | $ (2.93) |
Weighted average shares used in computing basic and diluted net loss per ordinary share | 35,639,745 | 26,984,183 | 25,036,465 |
License revenues | |||
Total | $ 8 | $ 975 | |
License revenues from related party | |||
Total | $ 7,528 | 4,121 | 3,940 |
Collaboration revenues | |||
Total | 4,638 | 7,164 | |
Collaboration revenues from related party | |||
Total | $ 3,756 | $ 4,340 | $ 13,019 |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||
Foreign currency translation adjustments, tax | $ (0.2) | $ 0.2 | $ (1.1) |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Ordinary shares | Additional paid-in capital | Accumulated other comprehensive income/(loss) | Accumulated deficit | Total |
Beginning balance at Dec. 31, 2015 | $ 1,542 | $ 455,897 | $ (6,828) | $ (322,684) | $ 127,927 |
Beginning balance (in shares) at Dec. 31, 2015 | 24,327,944 | ||||
Increase (decrease) in shareholders' equity | |||||
Loss for the period | (73,374) | (73,374) | |||
Other comprehensive income (loss) | 271 | 271 | |||
Exercise of share options | $ 41 | 2,542 | 2,583 | ||
Exercise of share options (in shares) | 750,408 | ||||
Shares distributed during the period | $ 10 | 10 | |||
Shares distributed during the period (in shares) | 179,068 | ||||
Share-based compensation expense | 6,214 | 6,214 | |||
Ending balance at Dec. 31, 2016 | $ 1,593 | 464,653 | (6,557) | (396,058) | 63,631 |
Ending balance (in shares) at Dec. 31, 2016 | 25,257,420 | ||||
Increase (decrease) in shareholders' equity | |||||
Loss for the period | (79,260) | (79,260) | |||
Other comprehensive income (loss) | 2,757 | 2,757 | |||
Follow-on public offering | $ 294 | 84,996 | 85,290 | ||
Follow-on public offering (in shares) | 5,000,000 | ||||
Shares issued as consideration in a business combination | $ 4 | 584 | 588 | ||
Shares issued as consideration in a business combination (in shares) | 64,648 | ||||
Exercise of share options | $ 32 | 4,088 | 4,120 | ||
Exercise of share options (in shares) | 603,740 | ||||
Exercises of convertible loan warrants | $ 7 | 1,946 | 1,953 | ||
Exercises of convertible loan warrants (in shares) | 114,172 | ||||
Restricted and performance share units distributed during the period | $ 17 | (17) | |||
Restricted and performance share units distributed during the period (in shares) | 299,060 | ||||
Share-based compensation expense | 10,280 | 10,280 | |||
Ending balance at Dec. 31, 2017 | $ 1,947 | 566,530 | (3,800) | (475,318) | $ 89,359 |
Ending balance (in shares) at Dec. 31, 2017 | 31,339,040 | 31,339,040 | |||
Increase (decrease) in shareholders' equity | |||||
Cumulative effect of retroactive implementation of ASC 606 Revenue recognition | 1,802 | 23,116 | $ 24,918 | ||
Loss for the period | (83,304) | (83,304) | |||
Other comprehensive income (loss) | (5,261) | (5,261) | |||
Follow-on public offering | $ 309 | 138,052 | 138,361 | ||
Follow-on public offering (in shares) | 5,175,000 | ||||
Exercise of share options | $ 19 | 4,741 | 4,760 | ||
Exercise of share options (in shares) | 425,074 | ||||
Restricted and performance share units distributed during the period | $ 24 | (24) | |||
Restricted and performance share units distributed during the period (in shares) | 409,948 | ||||
Share-based compensation expense | 10,708 | 10,708 | |||
Issuance of ordinary shares relating to employee stock purchase plan | 65 | 65 | |||
Issuance of ordinary shares relating to employee stock purchase plan (in shares) | 2,591 | ||||
Ending balance at Dec. 31, 2018 | $ 2,299 | $ 720,072 | $ (7,259) | $ (535,506) | $ 179,606 |
Ending balance (in shares) at Dec. 31, 2018 | 37,351,653 | 37,351,653 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities | |||
Net loss | $ (83,304) | $ (79,260) | $ (73,374) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation, amortization and impairment losses | 12,415 | 7,543 | 6,089 |
Share-based compensation expense | 10,708 | 10,280 | 6,214 |
Change in fair value of derivative financial instruments and contingent consideration | (4,054) | 5,194 | (1,865) |
Unrealized foreign exchange (gains) / losses | (5,502) | 4,222 | (755) |
Change in deferred taxes | 231 | 209 | 1,145 |
Change in lease incentives | (330) | 2,215 | 649 |
Changes in operating assets and liabilities: | |||
Accounts receivable and accrued income, prepaid expenses and other current assets | 1,578 | 9,715 | (5,917) |
Inventories | 480 | ||
Accounts payable | 1,065 | (1,670) | 344 |
Accrued expenses and other liabilities | (382) | (1,640) | 499 |
Deferred revenue | (8,462) | (21,078) | (5,698) |
Net cash used in operating activities | (76,037) | (64,270) | (72,189) |
Cash flows from investing activities | |||
Purchases of intangible assets | (1,861) | (1,122) | (1,884) |
Purchase of property, plant and equipment | (2,384) | (4,461) | (15,288) |
Net cash used in investing activities | (4,245) | (5,583) | (17,172) |
Cash flows from financing activities | |||
Proceeds from issuance of shares related to employee stock option and purchase plans | 4,825 | 4,044 | 2,593 |
Proceeds from exercises of convertible loan warrants | 1,322 | ||
Proceeds from pubic offering of shares, net of issuance costs | 138,361 | 85,290 | |
Proceeds from loan increment | 14,775 | ||
Contingent consideration payment | (582) | ||
Repayment of capital lease obligations | (148) | ||
Net cash generated from financing activities | 157,961 | 90,074 | 2,445 |
Currency effect cash, cash equivalents and restricted cash | (2,187) | 7,306 | (1,629) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 75,491 | 27,527 | (88,545) |
Cash, cash equivalents and restricted cash at beginning of period | 161,851 | 134,324 | 222,869 |
Cash, cash equivalents and restricted cash at the end of period | 237,342 | 161,851 | 134,324 |
Supplemental cash flow disclosures: | |||
Total cash, cash equivalents and restricted cash | 161,851 | 134,324 | 222,869 |
Cash paid for interest | 2,141 | 1,624 | 2,345 |
Non-cash (decreases) / increases in accounts payables related to purchases of intangible assets and property, plant and equipment | $ (48) | $ (1,557) | $ 1,174 |
General business information
General business information | 12 Months Ended |
Dec. 31, 2018 | |
General business information | |
General business information | 1. uniQure (the “Company”) was incorporated on January 9, 2012 as a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) under the laws of the Netherlands. The Company is a leader in the field of gene therapy and seeks to deliver to patients suffering from rare and other devastating diseases single treatments with potentially curative results. The Company’s business was founded in 1998 and was initially operated through its predecessor company, Amsterdam Molecular Therapeutics (AMT) Holding N.V (“AMT”). In 2012, AMT undertook a corporate reorganization, pursuant to which uniQure B.V. acquired the entire business and assets of AMT and completed a share-for-share exchange with the shareholders of AMT. Effective February 10, 2014, in connection with its initial public offering, the Company converted into a public company with limited liability (naamloze vennootschap) and changed its legal name from uniQure B.V. to uniQure N.V. The Company is registered in the trade register of the Dutch Chamber of Commerce (Kamer van Koophandel) under number 54385229. The Company’s headquarters are in Amsterdam, the Netherlands, and its registered office is located at Paasheuvelweg 25a, Amsterdam 1105 BP, the Netherlands and its telephone number is +31 20 240 6000. The Company’s website address is www.uniqure.com. The Company’s ordinary shares are listed on the NASDAQ Global Select Market and trades under the symbol “QURE”. |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2018 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2. Summary of significant accounting policies 2.1 Basis of preparation The Company prepared its consolidated financial statements in compliance with generally accepted accounting principles in the U.S. (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The consolidated financial statements have been prepared under the historical cost convention, except for derivative financial instruments and contingent consideration, which are recorded at fair value through profit or loss. The consolidated financial statements are presented in U.S. dollars, except where otherwise indicated. Transactions denominated in currencies other than U.S. dollars are presented in the transaction currency with the U.S. dollar amount included in parenthesis, converted at the foreign exchange rate as of the transaction date. The consolidated financial statements presented have been prepared on a going concern basis based on the Company’s cash and cash equivalents as of December 31, 2018 and the Company’s budgeted cash flows for the twelve months following the issuance date. 2.2 Use of estimates The preparation of consolidated financial statements, in conformity with U.S. GAAP and SEC rules and regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period. Estimates and assumptions are primarily made in relation to revenue recognition in the determination and measurement of performance obligations and assessment of the performance period over which license revenue is recognized, income taxes, including the realization of deferred tax assets, fair value of derivative financial instruments, share-based compensation, measurement of accrued expenses which have not yet been invoiced as of the balance sheet date and business combinations including contingent consideration payable. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate. 2.3 Accounting policies The principal accounting policies applied in the preparation of these consolidated financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated. 2.3.1 Consolidation The consolidated financial statements comprise the financial statements of the Company and its subsidiaries. Subsidiaries are all entities over which the Company has a controlling financial interest either through variable interest or through voting interest. Currently, the Company has no involvement with variable interest entities. Inter-company transactions, balances, income and expenses on transactions between uniQure entities are eliminated in consolidation. Profits and losses resulting from inter-company transactions that are recognized in assets are also eliminated. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Company. 2.3.2 Current versus non-current classification The Company presents assets and liabilities in the consolidated balance sheets based on current and non-current classification. The term current assets is used to designate cash and other assets or resources commonly identified as those that are reasonably expected to be realized in cash or sold or consumed during the normal operating cycle of the business. The Company’s normal operating cycle is twelve months. All other assets are classified as non-current. The term current liabilities is used principally to designate obligations whose liquidation is reasonably expected to require the use of existing resources properly classifiable as current assets, or the creation of other current liabilities. Current liabilities are expected to be settled in the normal operating cycle. The Company classifies all other liabilities as non-current. Deferred tax assets and liabilities are classified as non-current assets and liabilities. 2.3.3 Foreign currency translation The functional currency of the Company and each of its entities (with the exception of uniQure Inc.) is the euro (€). This represents the currency of the primary economic environment in which the entities operate. The functional currency of uniQure Inc. is the U.S. dollar. The consolidated financial statements are presented in U.S. dollars. Foreign currency transactions are measured and recorded in the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the re-measurement of monetary assets and liabilities denominated in foreign currencies at exchange rates prevailing at balance sheet date are recognized in profit and loss. Upon consolidation, the assets and liabilities of foreign operations are translated into the functional currency of the shareholding entity at the exchange rates prevailing at the balance sheet date; items of income and expense are translated at monthly average exchange rates. The consolidated assets and liabilities are translated from uniQure N.V.’s functional currency, euro, into the reporting currency U.S. dollar at the exchange rates prevailing at the balance sheet date; items of income and expense are translated at monthly average exchange rates. Issued capital and additional paid-in capital are translated at historical rates with differences to the balance sheet date rate recorded as translation adjustments in other comprehensive income / loss. The exchange differences arising on translation for consolidation are recognized in “accumulated other comprehensive income / loss”. On disposal of a foreign operation, the component of other comprehensive income / loss relating to that particular foreign operation is recognized in profit or loss. As the intercompany funding of the Company’s Lexington operations is neither planned nor likely to be settled in the foreseeable future, the associated foreign exchange effect is presented as accumulated other comprehensive income / loss. 2.3.4 Fair value measurement The Company measures certain assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. ASC 820, Fair Value Measurements and Disclosures , requires disclosure of methodologies used in determining the reported fair values, and establishes a hierarchy of inputs used when available. The three levels of the fair value hierarchy are described below: · Level 1 - Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. · Level 2 - Valuations based on quoted prices for similar assets or liabilities in markets that are not active or models for which the inputs are observable, either directly or indirectly. · Level 3 - Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and are unobservable. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Items measured at fair value on a recurring basis include financial instruments and contingent consideration (note 3, “Fair value measurement”). The carrying amount of cash and cash equivalents, accounts receivable from collaborators, prepaid expenses, other assets, accounts payable, accrued expenses and other current liabilities reflected in the consolidated balance sheets approximate their fair values due to their short-term maturities. 2.3.5 Business combination On July 31, 2014, the Company closed its acquisition of InoCard GmbH (“InoCard”). This transaction was accounted for as a business combination under the acquisition method of accounting. Accordingly, the tangible and intangible assets acquired and liabilities assumed were recorded at fair value as of the date of acquisition, with the excess purchase price recorded as goodwill. The estimated fair values of the assets acquired and liabilities assumed were determined using the methods discussed in the following paragraphs and required significant judgment and estimates, which could materially differ from actual values and fair values determined using different methods or assumptions. a. Goodwill Goodwill represents the excess of the purchase price over the fair value of the net assets acquired when accounted for using the acquisition method of accounting for business combinations. Goodwill is not amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis in the fourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s reporting unit below its carrying amount. The Company has not recognized any impairment charges related to goodwill. b. Acquired research and development Acquired research and development (“Acquired R&D”) represents the fair value assigned to intangible assets in incomplete research projects that the Company acquires through business combinations. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion, abandonment of the projects or when the research findings are commercialized through a revenue-generating project. Upon successful completion or commercialization of a project, uniQure will make a determination as to the then useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization. In case of abandonment, the asset will be written-off. See note 6, “Intangible assets,” for additional information. c. Contingent consideration Each reporting period, the Company revalues the contingent consideration obligations associated with this business combination to their fair value and records changes in the fair value within research and development expenses. Changes in contingent consideration result from changes in assumptions regarding the probabilities of successful achievement of related milestones, the estimated timing in which milestones are achieved and the discount rate used to estimate the fair value of the liability. Payments made soon after the acquisition date are recorded as cash flows from financing activities, and payments, or the portion of the payments, not made soon after the acquisition date are recorded as cash flows from operating activities. See note 3, “Fair value measurement,” for additional information. 2.3.6 Notes to the consolidated statements of cash flows The consolidated statements of cash flows have been prepared using the indirect method. The cash disclosed in the consolidated statements of cash flows is comprised of cash and cash equivalents. Cash and cash equivalents include bank balances, demand deposits and other short-term highly liquid investments (with maturities of less than three months at the time of purchase) that are readily convertible into a known amount of cash and are subject to an insignificant risk of fluctuation in value. Cash flows denominated in foreign currencies have been translated at the average exchange rates. Exchange differences, if any, affecting cash and cash equivalents are shown separately in the consolidated statements of cash flows. Interest paid and received, and income taxes are included in net cash (used in) provided by operating activities. 2.3.7 Segment information Operating segments are identified as a component of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as one operating segment, which comprises the discovery, development and commercialization of innovative gene therapies. 2.3.8 Net loss per share The Company follows the provisions of ASC 260, Earnings Per Share . In accordance with these provisions, loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share reflects the dilution that would occur if share options or warrants to issue common stock were exercised, or performance or restricted share units were distributed. However, potential common shares are excluded if their effect is anti-dilutive. The Company currently has no dilutive securities due to the net loss position and as such, basic and diluted net loss per share are the same for the periods presented. 2.3.9 Impairment of long-lived assets Long-lived assets, which include property, plant, and equipment and finite-lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying value of an asset or asset group may not be recoverable. The recoverability of the carrying value of an asset or asset group depends on the successful execution of the Company’s business initiatives and its ability to earn sufficient returns on approved products and product candidates. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the future undiscounted cash flows are less than the carrying amount of these assets, the Company recognizes an impairment loss based on the excess of the carrying value over the fair value of the assets. Fair value is determined through various valuation techniques, including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary. Goodwill is not amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis, during the fourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s reporting unit below its carrying amount. The Company performs the same quantitative analysis discussed above for long-lived assets and finite-lived intangible assets. 2.3.10 Intangible assets Acquired licenses have a finite useful life and are carried at cost less accumulated amortization and impairment losses. Amortization is calculated using the straight-line method to allocate the cost of licenses over their estimated useful lives (generally 20 years unless a license expires prior to that date). 2.3.11 Property, plant and equipment Property, plant and equipment is comprised mainly of laboratory equipment, leasehold improvements, construction-in-progress (“CIP”) and office equipment. All property, plant and equipment is stated at cost less accumulated depreciation. CIP consists of capitalized expenses associated with construction of assets not yet placed into service. Depreciation commences on CIP once the asset is placed into service based on its useful life determined at that time. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed as incurred. Upon disposal, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss on the transaction is recognized in the consolidated statements of operations and comprehensive loss. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets (or in the case of leasehold improvements a shorter lease term), which are as follows: Leasehold improvements Between 10 – 15 years Laboratory equipment 5 years Office equipment Between 3 – 5 years 2.3.12 Other (non) current assets Deposit paid are either presented as other current assets or as other non-current assets based on duration of the underlying contractual arrangement. Deposits are classified as restricted cash and primarily relate to facility leases. 2.3.13 Accounts receivable Accounts receivables are amounts due from services provided to the Company’s collaboration partner and are purely trade receivables. 2.3.14 Prepaid expenses Prepaid expenses are amounts paid in the period, for which the benefit has not been realized, and include payments made for insurance and research contracts. The related expense will be recognized in the subsequent period as incurred. 2.3.15 Accounts payable and accrued expenses Accounts payables are invoiced amounts related to obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts payables are recognized at the amounts invoiced by suppliers. Accrued expenses are recognized for goods or services that have been acquired in the ordinary course of business. 2.3.16 Long-term debt Long-term debt is initially recognized at cost and presented net of original issue discount or premium and debt issuance costs on the consolidated balance sheets. Amortization of debt discount and debt issuance costs is recognized as interest expense in profit and loss over the period of the debt, using the effective interest rate method. 2.3.17 Pensions and other post-retirement benefit plans The Company has a defined contribution pension plan for all employees at its Amsterdam facility in the Netherlands, which is funded by the Company through payments to an insurance company, with individual accounts for each participants’ assets. The Company has no legal or constructive obligation to pay further contributions if the plan does not hold sufficient assets to pay all employees the benefits relating to services rendered in the current and prior periods. The contributions are expensed as incurred. Prepaid contributions are recognized as an asset to the extent that a cash refund or a reduction in the future payments is available. Starting in 2016, the Company adopted a qualified 401(k) Plan for all employees at its Lexington facility in the USA, which offers both a pre-tax and post-tax (Roth) component. Employees may contribute up to 50% of their pre-tax compensation, which is subject to IRS statutory limits for each calendar year. The Company matches $0.50 for every $1.00 contributed to the plan by participants up to 6% of base compensation. Employer contributions are recognized as they are contributed, as long as the employee is rendering services in that period. If employer contributions are made in periods after an individual retires or terminates, the estimated cost is accrued during the employee’s service period. 2.3.18 Share-based compensation The Company accounts for its share-based compensation awards in accordance with ASC 718, Compensation-Stock Compensation and ASC Subtopic 505-50, Equity-Based Payments to Non-Employees . All of the Company’s share-based compensation plans for employees are equity-classified. ASC 718 requires all share-based compensation to employees, including grants of employee options, restricted share units, performance share units and modifications to existing instruments, to be recognized in the consolidated statements of operations and comprehensive loss based on their grant-date fair values, net of an estimated forfeiture rate, over the requisite service period. Forfeitures of employee options are recognized as they occur. ASC 505-50 requires all share-based compensation to non-employees to be recognized in the consolidated statements of operations and comprehensive loss based on their fair values, with the fair values being re-measured until completion of performance. The Company uses a Hull & White option model to determine the fair value of option awards. The model captures early exercises by assuming that the likelihood of exercises will increase when the share-price reaches defined multiples of the strike price. This analysis is performed over the full contractual term. 2.3.19 Revenue recognition The Company primarily generates revenue from its collaboration, research and license agreements with its collaboration partners for the development and commercialization of its product candidates. Revenue recognition in accordance with ASC 606: On January 1, 2018 the Company adopted new revenue recognition policies in accordance with ASC 606 using the modified retrospective approach. The new revenue recognition policies replace the revenue recognition standards under ASC 605. The Company elected to implement ASC 606 by applying it to active collaboration arrangements as of the Initial Application Date and to record a cumulative adjustment of revenue previously recognized to accumulated loss as of December 31, 2017. See note 2.3.23 “Recently Adopted Accounting Pronouncements” and note 4 “Collaboration” for additional information. Revenue recognition for the years ended 2017 and 2016: During the years ended December 31, 2017 and 2016 the Company applied ASC 605. The Company recognized revenue when earned and realized or realizable. Accordingly, revenue was recognized for each unit of accounting when all of the following criteria were met: · Persuasive evidence of an arrangement exists; · Delivery has occurred or services have been rendered; · The seller´s price to the buyer is fixed or determinable; · Collectability is reasonably assured. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s consolidated balance sheets. Multiple element arrangements were analyzed to determine whether the deliverables within the agreement can be separated or whether they must be accounted for as a single unit of accounting. Deliverables under an agreement are required to be accounted for as separate units of accounting provided that (i) a delivered item has value to the customer on a stand-alone basis; and (ii) if the agreement includes a general right of return relative to the delivered item, the delivery or performance of the undelivered item is considered probable and substantially in the control of the vendor. The allocation of consideration amongst the deliverables under the agreement is derived using a “best estimate of selling price” if vendor specific objective evidence and third-party evidence of fair value are not available. If the delivered element does not have stand-alone value or if the fair value of any of the undelivered elements cannot be determined, the arrangement is accounted for as a single unit of accounting. a. License revenues under ASC 605 License revenues consisted of up-front payments, target selection payments, milestone payments and royalties. Up-front and target selection payments Up-front payments, target selection payments or similar non-refundable payments were initially reported as deferred revenue on the consolidated balance sheets and were recognized as revenue on a straight-line basis over the period of the performance obligation. The estimated period of the performance obligation is re-assessed at each balance sheet date. Milestone payments and royalties Research-based milestone payments were recognized as revenues either on achievement of such milestones if the milestones were considered substantive or over the period the Company has continuing performance obligations, if the milestones were not considered substantive. When determining if a milestone is substantive, the Company considered the following factors: · The degree of certainty in achieving the milestone; · The frequency of milestone payments; · The Company’s efforts, which result in achievement of the milestone; · The amount of the milestone payment relative to the other deliverables and payment terms; and · Whether the milestone payment is related to future performance or deliverables. Sales-based milestone payments and royalties were recognized in earnings when earned. b. Collaboration revenue under ASC 605 Collaboration revenue consists of revenue generated from collaborative research and development arrangements. Services may include the provision of Company staff, consultants or other third-party vendors engaged by the Company in relation to a collaboration program and the manufacturing of gene therapeutic products to the extent these were reimbursed through the respective collaborative research and development program. Collaboration revenues, which were related to reimbursements from collaborators for the Company’s performance of research and development services under the respective agreements, were recognized on the basis of labor hours valued at a contractually agreed rate. Collaboration revenues include reimbursements for related out-of-pocket expenses. Cost reimbursements to which the Company was entitled under agreements were recognized as collaboration revenues in the same quarter of the recorded cost they were intended to compensate. 2.3.20 Other income, other expense The Company receives certain government and regional grants, which support its research efforts in defined projects, and include contributions towards the cost of research and development. These grants generally provide for reimbursement of approved costs incurred as defined in the respective grants and are deferred and recognized in the statements of operations and comprehensive loss over the period necessary to match them with the costs they are intended to compensate, when it is probable that the Company has complied with any conditions attached to the grant and will receive the reimbursement. The Company’s other income also consists of income from the subleasing of the Amsterdam facility while other expense consists of expenses incurred in relation to the subleasing income. Income from releasing outstanding deferred revenue in relation to the termination of the collaboration with Chiesi Cost incurred in 2017 in relation to terminating the marketing of its Glybera program, as well as costs associated with exiting its prior Amsterdam facilities and its Heidelberg site are presented as other expenses 2.3.21 Research and development expenses Research and development costs are expensed as incurred. Research and development expenses generally consist of laboratory research, clinical trials, statistical analysis and report writing, regulatory compliance costs incurred with clinical research organizations and other third-party vendors (including post-approval commitments to conduct consistency and comparability studies). In addition, research and development expenses consist of start-up and validation costs related to the Company’s Lexington facility and the development and improvement of the Company’s manufacturing processes and methods. 2.3.22 Income taxes Income taxes are recorded in accordance with ASC 740, Income Taxes , which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more-likely-than-not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more-likely-than-not be realized. The determination as to whether the tax benefit will more-likely-than-not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2018, and 2017, the Company did not have any significant uncertain tax positions. 2.3.23 Recently Adopted Accounting Pronouncements ASU 2014-09: ASC 606 Revenue from Contracts with Customers Effective January 1, 2018 the Company adopted new revenue recognition policies in accordance with ASC 606 using the modified retrospective approach. The new revenue recognition policies replace the revenue recognition standards under ASC 605. The Company elected to implement ASC 606 by applying it to active collaboration arrangements as of January 1, 2018 and to record a cumulative adjustment of revenue previously recognized to the accumulated loss as of December 31, 2017. The impact of implementing ASC 606 is summarized below: - Recognized $7.5 million of license revenue during the twelve months ended December 31, 2018, related to the collaboration with BMS compared to $4.2 million that would have been recognized in accordance with the previous revenue recognition policies; - Continued to present revenue recognized during the twelve months ended December 31, 2017 and December 31, 2016, in accordance with the previous revenue recognition policies; - Decreased the accumulated loss by $24.9 million as of January 1, 2018 and decreased deferred revenue as of the same date by $24.9 million. In accordance with the previous revenue recognition policies the Company had concluded that the BMS collaboration agreement consisted of three performance obligations, (i) technology (license and target selections), know‑how and manufacturing in the field of gene therapy and development and active contribution to the development through the joint steering committee participations, (ii) provision of employees, goods and services for research, and (iii) clinical and commercial manufacturing. The Company determined that these three performance obligations are substantially identical with the performance obligations in accordance with its new revenue recognition policies: (i) Providing access to its technology and know-how in the field of gene therapy as well as actively contributing to the target selection, the collaboration as a whole, the development during the target selection, the pre-clinical and the clinical phase through participating in joint steering committee and other governing bodies (“License Revenue”); (ii) Providing pre-clinical research activities (“Collaboration Revenue”); and (iii) Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”). License Revenue The Company previously recognized License Revenue over the expected performance period on a straight-line basis commencing on May 21, 2015. The Company now recognizes License Revenue over the expected performance period based on its progress toward the completion of its services (see note 4 for a detailed discussion). Collaboration and Manufacturing Revenue The adoption of the new revenue recognition policies did not materially impact the recognition of Collaboration or Manufacturing Revenue. ASU 2016-01: ASC 825 Recognition and Measurement of Financial Assets and Financial Liabilities In January 2016, the FASB issued ASU 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”). ASU 2016-01 addresses certain aspects of recognition, measurement, presentation and disclosure of financial instruments. ASU 2016-01 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, which for the Company was January 1, 2018. ASU 2016-01 did not have a material impact on our consolidated financial statements. ASU 2016-05: Derivatives and Hedging: Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships In March 2016, the FASB issued ASU 2016-05, Derivatives and Hedging: Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships (“ASU 2016-05”) and ASU 2016-06, Derivatives and Hedging: Contingent Put and Call Options in Debt Instruments. Both AS |
Fair value measurement
Fair value measurement | 12 Months Ended |
Dec. 31, 2018 | |
Fair value measurement | |
Fair value measurement | 3. Fair value measurement The Company measures certain financial assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. The carrying amount of cash and cash equivalents, accounts receivable from collaborators, prepaid expenses, other assets, accounts payable, accrued expenses and other current liabilities reflected in the consolidated balance sheets approximate their fair values due to their short-term maturities. The Company’s only material financial assets measured at fair value using Level 1 inputs is cash and cash equivalents. Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration and derivative financial instruments. Changes in Level 3 items during the years ended December 31, 2018, 2017 and 2016 are as follows: Derivative Contingent financial consideration instruments Total in thousands Balance at December 31, 2015 $ 2,926 $ 837 $ 3,763 Gains recognized in profit or loss (1,080) (785) (1,865) Currency translation effects (8) 10 2 Balance at December 31, 2016 $ 1,838 $ 62 $ 1,900 Exercises of convertible loan warrants — (631) (631) Losses recognized in profit or loss 3,002 2,192 5,194 Contingent consideration paid (1,181) — (1,181) Currency translation effects 305 12 317 Balance at December 31, 2017 $ 3,964 $ 1,635 $ 5,599 Gains recognized in profit or loss (3,846) (208) (4,054) Currency translation effects (118) (52) (170) Balance at December 31, 2018 $ — $ 1,375 $ 1,375 Contingent consideration In connection with the Company’s acquisition of the InoCard business (“InoCard”) in 2014, the Company recorded contingent consideration related to amounts potentially payable to InoCard’s former shareholders. The amounts payable in accordance with the sale and purchase agreement (as amended in August 2017) are contingent upon realization of milestones associated with its S100A1 protein research program. As of December 31, 2018, the Company does not expect to realize those milestones and recorded a $3.8 million gain within research and development expenses for the year ended December 31, 2018, to release the liability to profit and loss. Accordingly, the fair value of the contingent liability as of December 31, 2018 amounted to nil (December 31, 2017: $4.0 million and December 31, 2016: $1.8 million). The Company made $1.2 million in milestone payments related to the liability during the year ended December 31, 2017, 50% of which were settled through the issuance of 64,648 restricted ordinary shares on October 2, 2017. In addition, in 2017, the parties modified the conditions of the agreed milestone payments, including a reduction of the percentage of any future milestone that can be settled in the form of Company ordinary shares from 100% to 50%. The Company recorded $2.3 million in research and development cost in the year ended December 31, 2017, related to the increase in fair value of the contingent consideration resulting from these modifications. Derivative financial instruments The Company issued derivative financial instruments related to its collaboration with BMS and in relation to the issuance of the Hercules Technology Growth Corp. (“Hercules”) loan facility. The fair value of these derivative financial instruments as of December 31, 2018, was $1.4 million (December 31, 2017: $1.6 million), and these derivative financial instruments are described in more detail below. BMS collaboration On April 6, 2015, the Company entered into several agreements with BMS (the “BMS Agreements”). Pursuant to the terms of the BMS Agreements the Company granted BMS two warrants: · a warrant allowing BMS to purchase a specific number of uniQure ordinary shares such that its ownership will equal 14.9% immediately after such purchase. The warrant can be exercised on the later of (i) the date on which the Company receives from BMS the Target Designation Fees (as defined in the collaboration agreements) associated with the first six New Targets (as defined in the collaboration agreements); and (ii) the date on which BMS designates the sixth New Target; and · a warrant allowing BMS to purchase a specific number of uniQure ordinary shares such that its ownership will equal 19.9% immediately after such purchase. The warrant can be exercised on the later of (i) the date on which uniQure receives from BMS the Target Designation Fees associated with the first nine New Targets; and (ii) the date on which BMS designates the ninth New Target. Pursuant to the terms of the BMS Agreements the exercise price, in respect of each warrant, is equal to the greater of (i) the product of (A) $33.84, multiplied by (B) a compounded annual growth rate of 10% and (ii) the product of (A) 1.10 multiplied by (B) the VWAP for the 20 trading days ending on the date that is five trading days prior to the date of a notice of exercise delivered by BMS. The fair value of the warrants as of December 31, 2018 is $0.8 million (December 31, 2017: $1.3 million). During the year ended December 31, 2018, the Company recognized a $0.5 million gain in non-operating income / expense (December 31, 2017: $1.2 million loss; December 31, 2016: $0.5 million gain) related to fair value changes of the BMS warrants. The exercise of the warrants is expected to occur within 2 and 4 years after the balance sheet date. The Company classified the derivative financial liabilities as non-current at the balance sheet date. The Company used Monte-Carlo simulations to determine the fair market value of the BMS warrants. The valuation model incorporates several inputs, the risk-free rate adjusted for the period affected, an expected volatility based on a peer group analysis, the expected yield on any dividends and management’s expectations on the timelines of reaching certain defined trigger events for the exercising of the warrants, as well as management’s expectations regarding the number of ordinary shares that would be issued upon exercise of the warrants. All of these represent Level 3 inputs. Additionally, the model assumes BMS will exercise the warrants only if it is financially rational to do so. The Company conducted a sensitivity analysis to assess the impact on changes in assumptions on the fair value. Specifically, the Company examined the impact on the fair market of the warrants by increasing the volatility by 10% to 85%. A further sensitivity analysis was performed assuming the exercise date of the warrants would occur one year later than what was assumed in the initial valuation. The table below illustrates the impact on the fair market valuation associated with these changes in assumptions as of December 31, 2018. Total warrants in thousands Base case $ 803 Increase volatility by 10% to 85% 236 Extend exercise dates by one year 55 Hercules loan facility On June 14, 2013, the Company entered into a venture debt loan facility (the “Original Facility”) with Hercules (see note 8, “Long-term debt”) pursuant to a Loan and Security Agreement (the “Loan Agreement”), which included a warrant maturing on February 5, 2019. The warrant was not closely related to the host contract and was accounted for separately as a derivative financial liability measured at fair value though profit or loss. The warrant included in the Original Facility remained in place following the 2014, 2016 and 2018 amendments of the loan. The fair value of this derivative, recorded in other current liabilities, as of December 31, 2018 is $0.6 million (December 31, 2017: $0.3 million). During the year ended December 31, 2018, uniQure recognized a $0.3 million loss in other non-operating income / (expense) (December 31, 2017: $0.3 million loss; December 31, 2016: $0.3 million gain) related to fair value changes of the Hercules warrants. |
Collaboration arrangements and
Collaboration arrangements and concentration of credit risk | 12 Months Ended |
Dec. 31, 2018 | |
Collaboration arrangements and concentration of credit risk | |
Collaboration arrangements and concentration of credit risk | 4. Collaboration arrangements and concentration of credit risk In the year ended December 31, 2018, the Company generated all collaboration and license revenues from its Collaboration and License Agreement with BMS. The Company and Chiesi Farmaceutici S.p.A. (“Chiesi”) terminated their collaboration in 2017. As a result, the Company is not required to provide any further services to Chiesi. Since June 2015, BMS has been considered a related party given the significance of its equity investment in the Company (December 31, 2018: 2.4 million ordinary shares or 6.4% of outstanding ordinary shares). Services to the Company’s collaboration partners are rendered by the Dutch operating entity. Total collaboration and license revenue generated from these partners are as follows: Years ended December 31, 2018 2017 2016 in thousands Bristol Myers Squibb $ 11,284 $ 8,461 $ 16,959 Chiesi Farmaceutici S.p.A (terminated in 2017) — 4,646 8,139 Total $ 11,284 $ 13,107 $ 25,098 Amounts owed by BMS in relation to the collaboration services are as follows: December 31, December 31, 2018 2017 in thousands Bristol Myers Squibb $ 233 $ 1,586 Total $ 233 $ 1,586 BMS collaboration In May 2015, the Company closed a Collaboration and License Agreement with BMS (the “BMS Collaboration Agreement”) that provides exclusive access to the Company’s gene therapy technology platform for multiple targets in cardiovascular (and other target specific) diseases. In total, the companies may collaborate on ten targets. Upon BMS request the Company is conducting discovery, non-clinical, analytical and process development activities and is responsible for manufacturing of clinical and commercial supplies using the Company’s vector technologies and industrial, proprietary insect-cell based manufacturing platform. BMS reimburses the Company for all its research and development efforts in support of the Collaboration, and will lead the clinical development and regulatory activities across all programs. BMS will also be solely responsible for commercialization of all products from the collaboration. The Company evaluated the BMS Collaboration Agreement and determined that its performance obligations in accordance with its adoption of ASC 606 on January 1, 2018, are as follows: (i) Providing access to its technology and know-how in the field of gene therapy as well as actively contributing to the target selection, the collaboration as a whole, the development during the target selection, the pre-clinical and the clinical phase through participating in joint steering committee and other governing bodies (“License Revenue”); (ii) Providing pre-clinical research activities (“Collaboration Revenue”); and (iii) Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”). License Revenue – BMS The Company recognized $7.5 million of License Revenue for the year ended December 31, 2018 (December 31, 2017: $4.1 million, December 31, 2016: $3.9 million) in relation to a $60.1 million upfront payment recorded on May 21, 2015, as well as $15.0 million received in relation to the designation of the second, third and fourth collaboration target in August 2015 (together “Consideration”). The Company will also be entitled to an aggregate of $16.5 million in target designation payments upon the selection of the fifth through tenth collaboration targets. The Company will also be eligible to receive research, development and regulatory milestone payments of up to $254.0 million for a lead target and up to $217.0 million for each of the other selected targets, if milestones are achieved. The Company will include the variable consideration related to the selection of the fifth to tenth collaboration target, or any of the milestones, in the transaction price once it is considered probable that including these payments in the transaction price would not result in the significant reversal of cumulative revenue recognized. The Company will recognize significant amounts of License Revenue for services performed in prior periods if and when the Company considers this probable. Due to the significant uncertainty surrounding the development of gene-therapy product candidates and the dependence on BMS’s performance and decisions the Company does not currently consider this probable. Additionally, the Company is eligible to receive net sales-based milestone payments and tiered mid-single to low double-digit royalties on product sales. The royalty term is determined on a licensed-product-by-licensed-product and country-by-country basis and begins on the first commercial sale of a licensed product in a country and ends on the expiration of the last to expire of specified patents or regulatory exclusivity covering such licensed product in such country or, with a customary royalty reduction, ten years after the first commercial sale if there is no such exclusivity. These revenues will be recognized when performance obligations are satisfied. Under the previous revenue standard, the Company recognized License Revenue over the expected performance period on a straight-line basis commencing on May 21, 2015. In accordance with the new revenue recognition standards, the Company recognizes License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services. The Company determines such progress by comparing activities performed at the end of each reporting period with total activities expected to be performed. The Company estimates total expected activities using a number of unobservable inputs, such as the probability of BMS designating additional targets, the probability of successfully completing each phase and estimated time required to provide services during the various development stages. If available, the Company uses product candidate-specific research and development plans. Alternatively, the Company assumes that completion of the pre-clinical phase requires an average of four years and that clinical development and commercial launch on average require 8.5 years. The estimation of total services at the end of each reporting period involves considerable judgement. The estimated number of product candidates that BMS will pursue significantly impacts the amount of License Revenue the Company recognizes. For example, if the Company would increase the probability of all additional targets being designated by 10% then the revenue for the annual period ended December 31, 2018 would have decreased by approximately $2.2 million to $5.3 million, as the Company would be required to render more services in relation to the Consideration received. Collaboration Revenue – BMS The Company provides target-specific research and development services to BMS. Collaboration Revenue related to these contracted services is recognized when performance obligations are satisfied. The Company generated $3.8 million collaboration revenue for the year ended December 31, 2018 (December 31, 2017: $4.3 million; December 31, 2016: $13.0 million). Manufacturing Revenue – BMS BMS and the Company also entered into Master Clinical Supply Agreement in April 2017 for the Company to supply gene therapy products during the clinical as well as into a binding term sheet to supply gene therapy products during the commercial phase to BMS. Revenues from product sales will be recognized when earned. To date the Company has not supplied any clinical and commercial gene therapy product to BMS. Chiesi collaboration In 2013, the Company entered into two agreements with Chiesi, one for the co-development and commercialization of the hemophilia B program (the “Hemophilia Collaboration Agreement”) and one for the commercialization of Glybera (the “Glybera Agreement”, and together with the Collaboration Agreement, the “Chiesi Agreements”) in Europe and selected territories. In April 2017, the parties agreed to terminate the Glybera Agreement. As of October 2017, the Company is not required to supply Glybera to Chiesi. In July 2017, the parties terminated the Hemophilia Collaboration Agreement and the Company reacquired rights associated with its hemophilia B program in Europe and selected territories. License Revenue – Chiesi Upon the closing of the Chiesi Agreements on June 30, 2013, the Company received €17.0 million ($22.1 million) in non-refundable up-front payments. The Company determined that the up-front payments constituted a single unit of accounting that should be amortized as License Revenue on a straight-line basis over the performance period of July 2013 through September 2032. In July 2017, the Company fully released the outstanding deferred revenue and recorded $13.8 million other income during the year ended December 31, 2017. The Company recognized no License Revenue for the year ended December 31, 2018 (December 31, 2017: $0.0 million; December 31, 2016: $1.0 million). The Company recognized the License Revenue for the year ended December 31, 2017, net of a $0.5 million reduction for amounts previously amortized and repaid by the Company in accordance with the Glybera Termination Agreement in 2017. Collaboration Revenue – Chiesi Prior to the termination of the Hemophilia Collaboration Agreement up to June 30, 2017, Chiesi reimbursed the Company for 50% of the agreed research and development efforts related to hemophilia B. These reimbursable amounts have been presented as Collaboration Revenue. The Company generated no Collaboration Revenue for the year ended December 31, 2018 (December 31, 2017: $4.6 million; December 31, 2016: $7.2 million) from the co-development of hemophilia B. |
Property, plant and equipment,
Property, plant and equipment, net | 12 Months Ended |
Dec. 31, 2018 | |
Property, plant and equipment, net | |
Property, plant and equipment, net | 5. Property, plant and equipment, net The following table presents the Company’s property, plant and equipment as of December 31: December 31, December 31, 2018 2017 in thousands Leasehold improvements $ 32,462 $ 32,297 Laboratory equipment 16,685 15,976 Office equipment 2,853 2,304 Construction-in-progress 73 745 Total property, plant, and equipment 52,073 51,322 Less accumulated depreciation (22,894) (17,041) Property, plant and equipment, net $ 29,179 $ 34,281 Total depreciation expense was $6.5 million for the year ended December 31, 2018 (December 31, 2017: $7.0 million, December 31, 2016: $5.5 million). Depreciation expense is allocated to research and development to the extent it relates to the Company’s manufacturing facility and equipment. All other depreciation expenses are allocated to selling, general and administrative expense. The following table summarizes property, plant and equipment by geographic region. December 31, December 31, 2018 2017 in thousands Lexington, Massachusetts (United States of America) $ 14,598 $ 17,177 Amsterdam (the Netherlands) 14,581 17,104 Total $ 29,179 $ 34,281 |
Intangible assets
Intangible assets | 12 Months Ended |
Dec. 31, 2018 | |
Intangible assets | |
Intangible assets | 6. Intangible assets a. Acquired licenses The following table presents the Company’s acquired licenses as of December 31: December 31, December 31, 2018 2017 in thousands Licenses $ 7,528 $ 9,551 Less accumulated amortization and impairment (2,327) (5,575) Licenses, net $ 5,201 $ 3,976 Acquired research and development — 5,594 Intangible assets, net $ 5,201 $ 9,570 All intangible assets are owned by uniQure biopharma B.V, a subsidiary of the Company. The acquired licenses have a weighted average remaining life of 12.6 years. During the year ended December 31, 2018, the Company capitalized $1.9 million of expenditures related to contractual milestone payments under existing license agreements as well as costs incurred in relation to entering into new license agreements. During the same period the Company disposed a number of fully amortized, expired licenses . As of December 31, 2018, the estimated future amortization expense for each of the five succeeding years and the period thereafter is as follows: Years Amount in thousands 2019 $ 471 2020 471 2021 462 2022 433 2023 433 Thereafter 2,931 Total $ 5,201 The carrying amount of the Company’s licenses by licensor is set out below. December 31, December 31, 2018 2017 in thousands Protein Sciences Corporation $ 2,084 $ 2,340 St. Jude Children’s Hospital 633 707 Other 2,484 929 Total $ 5,201 $ 3,976 The amortization expense related to licenses for the year ended December 31, 2018 was $0.4 million (December 31, 2017: $1.0 million; December 31, 2016: $0.3 million). All amortization was included in research and development expenses, except for $0.6 million related to the termination of the Chiesi collaboration, which was presented in other expense in the year ended December 31, 2017. b. Acquired research and development (“Acquired R&D”) The Company acquired research and development assets as part of its acquisition of InoCard in July 2014. Based on the review of pre-clinical data associated with those assets, the Company does not expect that it will pursue further research related to those assets. Accordingly, the Company recorded a $5.4 million impairment loss within research and development expenses in the year ended December 31, 2018, to reduce the asset’s carrying amount to its fair value of nil. The carrying amount as at December 31, 2017 was $5.6 million. |
Accrued expenses and other (non
Accrued expenses and other (non) current liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Accrued expenses and other (non) current liabilities | |
Accrued expenses and other (non) current liabilities | 7. Accrued expenses and other (non) current liabilities Accrued expenses and other current liabilities include the following items: December 31, December 31, 2018 2017 in thousands Accruals for services provided by vendors-not yet billed $ 1,999 $ 2,348 Personnel related accruals and liabilities 5,688 5,646 Other current liabilities 545 844 Total $ 8,232 $ 8,838 In December 2016, the Company and Extera Partners agreed to settle an arbitration case for a total amount of $2.9 million paid in December 2016 (including legal and related settlement costs). The expense is presented as selling, general and administrative expense in the consolidated statements of operations and comprehensive loss. Restructuring plan In November 2016, the Company announced a plan to restructure its activities with the aim of refocusing its pipeline, consolidating its manufacturing capabilities into its Lexington, Massachusetts site, reducing operating costs and enhancing overall execution. At various dates between December 2016 and February 2018, the Company entered into termination agreements with certain employees. Depending on the individual case pattern the Company accrues the related termination costs over the service period or at the date of communication to the employees. Changes in accrued termination benefits (included in research and development expenses) for the year ended December 31, 2018, are detailed in the table below: Accrued termination benefits in thousands Balance at December 31, 2017 $ 625 Accrued through operations 96 Payments (725) Currency translation effects 4 Balance at December 31, 2018 $ — |
Long-term debt
Long-term debt | 12 Months Ended |
Dec. 31, 2018 | |
Long-term debt | |
Long-term debt | 8. Long-term debt On June 14, 2013, the Company entered into a venture debt loan facility with Hercules, which was amended and restated on June 26, 2014, and again on May 6, 2016 (“2016 Amended Facility”). The 2016 Amended Facility extended the maturity date from June 30, 2018, to May 1, 2020. As of December 31, 2017, and December 31, 2016, $20.0 million was outstanding. The interest rate is adjustable and is the greater of (i) 8.25% or (ii) 8.25% plus the prime rate less 5.25%. Under the 2016 Amended Facility, the interest rate initially was 8.25% per annum. The interest-only payment period was extended by 12 months to November 2018 as a result of raising more than $50.0 million in equity financing in October 2017. On December 6, 2018, the Company signed an amendment to the Second Amended and Restated Loan and Security Agreement that both refinanced the existing $20 million 2016 Amended Facility and provided an additional commitment of $30 million (of which $15 million is subject to the discretion of Hercules) (the “2018 Amended Facility”). At signing, the Company drew down an additional $15 million for a total of $35 million outstanding. The Company has the right to draw another $15 million through June 30, 2020 subject to the terms of the 2018 Amended Facility. The 2018 Amended Facility extends the loan’s maturity date from May 1, 2020 until June 1, 2023. The interest-only period is extended from November 2018 to January 1, 2021, or in the event that specified conditions are met, the interest-only period may be extended to January 1, 2022. The Company is required to repay the facility in equal monthly installments of principal and interest between the end of the interest-only period and the maturity date. The interest rate continues to be adjustable and is the greater of (i) 8.85% or (ii) 8.85% plus the prime rate less 5.50% per annum. Under the 2018 Amended Facility, the Company paid a facility fee of 0.50% of the $35,000,000 outstanding as of signing and will owe a back-end fee of 4.95% of the outstanding debt. In addition, in May 2020 the Company owes a back-end fee of 4.85% of $20 million, which is the amount of debt raised under the 2016 Amended Facility. The amortized cost was $35.7 million as of December 31, 2018, compared to $20.8 million as of December 31, 2017, and is recorded net of discount and debt issuance costs. The foreign currency loss on the loan was $0.9 million in 2018 (December 31, 2017: gain of $2.6 million; December 31, 2016: loss of $0.9 million). The fair value of the loan approximates its carrying amount. Inputs to the fair value of the loan are considered Level 3 inputs. Interest expense recorded during the years ended December 31 was as follows: Years Amount in millions 2018 $ 2.0 2017 2.2 2016 2.2 As a covenant in the 2018 Amended Facility, the Company has periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the United States, equivalent to the lesser of the outstanding 65% balance of principal due and worldwide cash reserves. This restriction on the cash reserves only relates to the location of the cash reserves, and such cash reserves can be used at the discretion of the Company. In combination with other covenants, the 2018 Amended Facility restricts the Company’s ability to, among other things, incur future indebtedness and obtain additional debt financing, to make investments in securities or in other companies, to transfer assets, to perform certain corporate changes, to make loans to employees, officers and directors, and to make dividend payments and other distributions. The Company secured the facilities by pledging the shares in its subsidiaries, substantially all its receivables, moveable assets as well as the equipment, fixtures, inventory and cash of uniQure Inc. The 2018 Amended Facility contains provisions that include the occurrence of a material adverse effect, as defined therein, which would entitle Hercules to declare all principal, interest and other amounts owed by the Company immediately due and payable. As of December 31, 2018, the Company was in compliance with all covenants and provisions. The aggregate maturities of the loan, including $13.2 million of coupon interest payments and financing fees, for each of the 53 months subsequent to December 31, 2018, are as follows: Years Amount in thousands 2019 $ 3,119 2020 4,119 2021 15,657 2022 15,657 2023 9,625 Total $ 48,177 |
Shareholders' equity
Shareholders' equity | 12 Months Ended |
Dec. 31, 2018 | |
Shareholders’ equity | |
Shareholders' equity | 9. Shareholders’ e quity As of December 31, 2018, the Company’s authorized share capital is €3.0 million (exchange rate as of December 31, 2018, of 1.14449 $ / €; $3.4 million), divided into 60,000,000 ordinary shares, each with a nominal value of €0.05. Under Dutch law, the authorized share capital is the maximum capital that the Company may issue without amending its articles of association. All ordinary shares issued by the Company were fully paid. Besides the minimum amount of share capital to be held under Dutch law, there are no distribution restrictions applicable to the equity of the Company. As of December 31, 2018, and 2017 and 2016 the Company’s reserves were restricted for payment of dividends for accumulated foreign currency translation losses of $7.3 million, $3.8 million and $6.6 million, respectively. On May 7, 2018, the Company completed a follow-on public offering of 5,175,000 ordinary shares at $28.50 per ordinary share, resulting in gross proceeds to the Company of approximately $147.5 million. The net proceeds to the Company from this offering were approximately $138.4 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company capitalized $0.2 million of expenses related to this offering (which were deducted from additional paid-in capital in the accompanying consolidated balance sheet). On October 27, 2017, the Company completed its follow-on public offering announced on October 23, 2017. The Company issued and sold 5,000,000 ordinary shares at $18.25 per ordinary share, resulting in gross proceeds to the Company of approximately $91.3 million. The net proceeds to the Company from this offering were approximately $85.3 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company capitalized $0.5 million of expenses related to this offering (deducted from additional paid in capital in the accompanying consolidated balance sheet). In December 2017 the Company issued a total of 114,172 restricted ordinary shares in relation to the exercise of 128,710 warrants issued to former lenders of a loan, which was converted into equity in July 2013 prior to the Company’s initial public offering. The ordinary shares were issued at an exercise price of €10.10, or approximately $12.0 depending on the foreign exchange rate as of the date of warrant exercise. Certain of these lenders (Forbion and Coller) continue to qualify as related parties to the Company. On May 2, 2018, the Company and Leerink mutually terminated with immediate effect the September 2017 Sales Agreement with Leerink for an at-the-market offering program (“ATM program”). The ATM program allowed for the offer and sale of up to 5 million ordinary shares at prevailing market prices from time to time. The Company did not offer or sell any ordinary shares under the ATM program. |
Share-based compensation
Share-based compensation | 12 Months Ended |
Dec. 31, 2018 | |
Share-based compensation | |
Share-based compensation | 10. Share-based compensation Share-based compensation expense recognized by classification included in the consolidated statements of operations and comprehensive loss was as follows: Years ended December 31, 2018 2017 2016 Research and development - employees $ 3,994 $ 3,945 $ 3,302 Selling, general and administrative - employees 6,699 6,335 2,242 Research and development - non-employees — — 670 Total $ 10,693 $ 10,280 $ 6,214 Share-based compensation expense recognized by award type was as follows: Years ended December 31, 2018 2017 2016 Award type Share options $ 4,766 $ 3,246 $ 5,187 Restricted share units (“RSUs”) 3,020 2,588 528 Performance share units (“PSUs”) 2,907 4,446 499 Total $ 10,693 $ 10,280 $ 6,214 As of December 31, 2018, the unrecognized compensation cost related to unvested awards under the various share-based compensation plans were: Weighted-average Unrecognized remaining compensation period for costs recognition Award type in thousands in years Share options $ 14,489 3.13 Restricted share units 4,055 2.12 Performance share units 4,934 1.62 Total $ 23,478 2.64 The Company satisfies the exercise of share options and vesting of RSUs and PSUs through newly issued shares. The Company’s share-based compensation plans include the 2014 Amended and Restated Share Option Plan (the “2014 Plan”) and inducement grants under Rule 5653(c)(4) of the NASDAQ Global Select Market with characteristics similar to the 2014 Plan. The Company previously had a 2012 Equity Incentive Plan (the “2012 Plan”). As of December 31, 2018, 32,567 fully vested share options are outstanding (December 31, 2017: 72,818). At the general meeting of shareholders on January 9, 2014, the Company’s shareholders approved the adoption of the 2014 Plan. At the annual general meetings of shareholders in June 2015, 2016 and 2018, uniQure shareholders approved amendments of the 2014 Plan, increasing the shares authorized for issuance by 1,070,000 shares in 2015, 3,000,000 in 2016 and 3,000,000 shares in 2018, for a total of 8,601,471 shares. Share options Share options are granted on the date of grant and, except for certain grants made to non-executive directors, vest over a period of four years. The first 25% vests after one year from the initial grant date and the remainder vests in equal quarterly installments over the remaining three years. Certain grants to non-executive directors vest in full after one year. Any options that vest must be exercised by the tenth anniversary of the initial grant date. The following table summarizes option activity under the Company’s 2014 Plan for the year ended December 31, 2018: Weighted average Weighted average Aggregate intrinsic Options exercise price remaining contractual life value in years in thousands Outstanding at December 31, 2017 2,456,433 $ 10.06 7.98 $ 24,213 Granted 937,832 $ 26.18 Forfeited (315,342) $ 13.27 Expired (17,008) $ 17.87 Exercised (388,203) $ 11.48 Outstanding at December 31, 2018 2,673,712 $ 15.09 7.98 39,616 Fully vested and exercisable at December 31, 2018 1,073,915 $ 10.80 6.90 19,348 Outstanding and expected to vest at December 31, 2018 1,599,797 $ 17.96 8.70 20,268 Outstanding and expected to vest at December 31, 2017 1,680,491 $ 8.62 Total weighted average grant date fair value of options issued during 2018 (in $ millions) $ 14.9 Granted to directors and officers during 2018 (options, $ in millions) 315,156 $ 4.7 Proceeds from option sales during 2018 (in $ millions) $ 4.5 The following table summarizes information about the weighted average grant-date fair value of options during the years ended December 31: Weighted average Options grant‑date fair value Granted, 2018 937,832 $ 15.90 Granted, 2017 1,295,350 3.87 Granted, 2016 1,024,178 6.67 Vested, 2018 689,892 5.08 Forfeited, 2018 (315,342) 7.96 The following table summarizes information about the weighted average grant-date fair value of options at December 31: Weighted average Options grant‑date fair value Outstanding and expected to vest, 2018 1,599,797 $ 10.83 Outstanding and expected to vest, 2017 1,680,491 5.06 The fair value of each option issued was estimated at the date of grant using the Hull & White option pricing model with the following weighted-average assumptions: Years ended December 31, Assumptions 2018 2017 2016 Expected volatility 75%-80% 75%-80% 75% Expected terms (in years) 10 years 10 years 10 years Risk free interest rate 2.67% - 3.20% 2.39% - 2.81% 0.16% - 2.67% Expected dividends 0% 0% 0% The Hull & White option model captures early exercises by assuming that the likelihood of exercises will increase when the share price reaches defined multiples of the strike price. This analysis is performed over the full contractual term. The following table summarizes information about options exercised during the years ended December 31: Exercised during the year Intrinsic value in thousands 2018 388,203 $ 7,515 2017 198,552 1,291 2016 239,861 3,039 Restricted Share Units The following table summarizes the RSU activity for the year ended December 31, 2018: RSU Weighted average grant-date fair Number of shares value Non-vested at December 31, 2017 683,663 $ 6.38 Granted 262,599 $ 23.61 Vested (341,833) $ 6.43 Forfeited (192,108) $ 8.15 Non-vested at December 31, 2018 412,321 $ 16.49 Total weighted average grant date fair value of RSUs granted during 2018 (in millions) $ 6.2 Granted to directors and officers during 2018 (shares, $ in millions) 133,808 $ 3.3 The following table summarizes information about the weighted average grant-date fair value of RSUs granted during the years ended December 31: Granted Weighted average during the year grant‑date fair value 2018 262,599 $ 23.61 2017 603,350 5.86 2016 358,678 9.05 The following table summarizes information about the total fair value of RSUs that vested during the years ended December 31: Total fair value in thousands 2018 $ 8,546 2017 2,917 2016 2,296 Performance Share Units (PSUs) The following table summarizes the PSU activity for the year ended December 31, 2018: PSU Weighted average grant-date fair Number of shares value Non-vested at December 31, 2017 511,074 $ 16.73 Granted — $ — Vested (68,115) $ 15.79 Forfeited (65,790) $ 17.44 Non-vested at December 31, 2018 377,169 $ 16.73 PSUs awarded but not yet earned 136,982 $ 28.82 Total non-vested and discretionary PSUs 514,151 $ 19.95 Total weighted average grant date fair value of PSUs awarded during the period (in millions) $ 3.9 In January 2018, the Company awarded PSUs to its executives and other members of senior management. These PSUs were earned in February 2019 based on the Board’s assessment of the level of achievement of agreed upon performance targets through December 31, 2018. The PSUs awarded for the year ended December 31, 2018 will vest on the third anniversary of the grant, subject to the grantee’s continued employment. The following table summarizes information about the weighted average grant-date fair value, determined at of the date these were earned, of PSUs granted during the years ended December 31: Granted Weighted average during the year grant‑date fair value 2018 — $ — 2017 550,570 $ 17.15 2016 111,564 $ 5.76 The following table summarizes information about the total fair value of PSUs that vested during the years ended December 31: Total fair value in thousands 2018 $ 1,350 2017 1,730 2016 N/A Employee Share Purchase Plan (“ESPP”) In June 2018 the Company’s shareholders adopted and approved an ESPP allowing the Company to issue up to 150,000 ordinary shares. The ESPP is intended to qualify under Section 423 of the Internal Revenue Code of 1986. Under the ESPP, employees are eligible to purchase ordinary shares through payroll deductions, subject to any plan limitations. The purchase price of the shares on each purchase date is equal to 85% of the lower of the closing market price on the offering date or the closing market price on the purchase date of each three-month offering period. For the current year ended December 31, 2018, 2,591 shares have been issued. 2012 Plan The following table summarizes option activity under the Company’s 2012 Plan for the year ended December 31, 2018: 2012 plan Weighted average Weighted average Aggregate intrinsic Options exercise price remaining contractual life value in years in thousands Outstanding at December 31, 2017 72,818 € 5.77 3.00 $ 922 Exercised (40,251) € 6.21 Forfeited — € — Expired — € — Outstanding, fully vested and exercisable at December 31, 2018 32,567 € 5.23 3.62 939 Proceeds from option sales (in million) $ 0.3 The following table summarizes information about options exercised during the years ended December 31: Exercised during the year Intrinsic value in thousands 2018 40,251 $ 964 2017 405,188 1,176 2016 510,547 4,381 |
Expenses by nature
Expenses by nature | 12 Months Ended |
Dec. 31, 2018 | |
Expenses by nature | |
Expenses by nature | 11. Expenses by nature Operating expenses excluding expenses presented in other expenses included the following expenses by nature: Years ended December 31, 2018 2017 2016 in thousands Employee-related expenses $ 46,254 $ 46,373 $ 42,260 Laboratory and development expenses 23,596 17,737 21,054 Office and housing expenses 7,281 9,327 10,384 Legal and advisory expenses 7,748 8,121 11,715 Depreciation, amortization and impairment expenses 12,415 6,779 6,089 Patent and license expenses 1,202 817 1,348 Non-employee share-based compensation expenses — — 670 Other operating expenses 1,618 7,653 4,989 Total $ 100,114 $ 96,807 $ 98,509 Details of employee-related expenses for the year ended December 31 are as follows: Years ended December 31, 2018 2017 2016 in thousands, except for employee numbers Wages and salaries $ 26,646 $ 25,131 $ 24,999 Share-based compensation expenses 10,708 10,280 5,544 Consultant expenses 2,974 4,758 5,873 Social security costs 2,231 2,077 1,824 Health insurance 1,750 1,536 1,099 Pension costs-defined contribution plans 628 802 1,088 Other employee expenses 1,317 1,789 1,833 Total $ 46,254 $ 46,373 $ 42,260 Number of employees at the end of the period 212 202 251 |
Other non-operating income _ (e
Other non-operating income / (expense) | 12 Months Ended |
Dec. 31, 2018 | |
Other non-operating income / (expense) | |
Other non-operating income / (expense) | 12. Other non-operating income / (expense) Other non-operating income / (expense) consists of changes in the fair value of derivative financial instruments. Years ended December 31, 2018 2017 2016 in thousands Other non-operating income: Derivative gains $ 208 $ — $ 785 Total other non-operating income: 208 — 785 Other non-operating expense: Derivative losses — (2,192) — Finance expenses — (243) — Total other non-operating expense: — (2,435) — Other non-operating income / (expense), net $ 208 $ (2,435) $ 785 The Company recorded a net gain of $0.5 million for the year ended December 31, 2018, compared to a net loss of $1.2 million and a net gain of $0.5 million for the years ended December 31, 2017 and December 31, 2016, respectively, related to the derivative financial instruments issued as part of its collaboration with BMS and a net loss of $0.3 million for the year ended December 31, 2018 (December 31, 2017: $0.3 million net loss; December 31, 2016: $0.3 million net gain) related to warrants issued to Hercules (see note 3, “Fair value measurement”). |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income taxes | |
Income taxes | 13. Income taxes a. Income tax benefit / (expense) No current tax charges or liabilities were recorded in 2018, 2017 and 2016 by the Company’s Dutch and U.S entities since these entities generated losses. Due to the uncertainty surrounding the realization of favorable tax attributes in future tax returns, the Company has recorded a full valuation allowance against the Company’s otherwise recognizable net deferred tax assets. For the years ended December 31, 2018, 2017 and 2016, loss before income taxes consists of the following: Years ended December 31, 2018 2017 2016 in thousands Dutch operations $ (85,721) $ (60,966) $ (51,107) U.S. operations 2,646 (18,493) (21,221) Foreign operations 3 — 99 Total $ (83,073) $ (79,459) $ (72,229) The income tax benefit / (expense) for the years ended December 31, 2018, 2017 and 2016, consists of the following: Years ended December 31, 2018 2017 2016 in thousands Current benefit / (expense) Dutch operations $ — $ — $ — U.S. operations — — — Foreign operations (22) (10) (51) Deferred benefit / (expense) Dutch operations (209) 209 (1,094) U.S. operations — — — Foreign operations — — — Total income tax benefit / (expense) $ (231) $ 199 $ (1,145) b. Tax rate reconciliation The reconciliation of the Dutch statutory income tax rate to the Company’s effective tax rate for the years ended December 31, 2018, 2017 and 2016, is as follows: Years ended December 31, 2018 2017 2016 in thousands Net loss before tax for the period $ (83,073) $ (79,459) $ (72,229) Expected tax benefit / (expense) at the tax rate enacted in the Netherlands (25%) 20,768 19,865 18,057 Difference in tax rates between the Netherlands and foreign countries (106) 1,664 1,905 Net change in valuation allowance (19,207) (17,358) (20,054) Non-deductible expenses (2,648) (3,248) (1,323) Change in fair value of contingent consideration 962 (724) 270 Income tax benefit / (expense) $ (231) $ 199 $ (1,145) Non-deductible expenses predominantly relate to share-based compensation expenses for an amount of $2.7 million in 2018 (2017: $2.5 million; 2016: $1.6 million) and non-deductible results on derivative financial instruments of $0.0 million (2017: $0.5 million; 2016: $0.0 million). c. Significant components of deferred taxes The tax effects of temporary differences that give rise to significant portions of deferred tax assets and deferred tax liabilities at December 31, 2018 and 2017 are as follows: Years ended December 31, 2018 2017 in thousands Deferred tax assets: Net operating loss carryforwards $ 74,529 $ 73,207 Intangible assets 847 924 Property, plant and equipment 561 173 Deferred revenue 7,481 17,930 Accrued expenses and other current liabilities 1,682 1,657 Gross deferred tax asset $ 85,100 $ 93,891 Less valuation allowance (85,100) (93,682) Net deferred tax asset $ — $ 209 Long-term loan to foreign operations — (209) Net deferred tax liability $ — $ (209) Net deferred tax asset / (liability) $ — $ — Changes in the valuation allowance were as follows: Years ended December 31, 2018 2017 2016 in thousands January 1, $ 93,682 $ 82,642 $ 65,593 Changes related to reduction of deferred revenue recorded in equity upon implementation of ASC 606 Revenue recognition as of January 1, 2018 (6,229) — — Changes recorded in profit and loss 19,207 19,080 20,054 Reduction related to 2018 Dutch tax reform (15,670) — — Reduction related to 2017 US tax reform — (1,722) — Other changes including currency translation effects (5,890) (6,318) (3,005) December 31, $ 85,100 $ 93,682 $ 82,642 The valuation allowance at December 31, 2018 was primarily related to net operating loss carryforwards that, in the judgment of management, are not more-likely than-not to be realized. Management considered projected future taxable income and tax-planning strategies in making this assessment. In the Netherlands, changes to corporate taxes were enacted in December 2018. The changes reduce the corporate tax rate from 25% to 22.55% for the fiscal year 2020 and to 20.5%, effective January 1, 2021. The Company remeasured its temporary difference using a rate of 20.5% instead of the 25% rate effective in 2018 as it does not expect to utilize any of its loss carryforwards prior to 2021. This resulted in a $15.6 million reduction of both the gross deferred tax asset and the valuation allowance in the year ended December 31, 2018. The December 2018 tax reform also limits the carryforward of tax losses arising from January 1, 2019, to six years after the end of the respective period. Tax losses incurred prior to this date continue to expire nine years after the end of the respective period. The Dutch fiscal unity has as of December 31, 2018 an estimated $311.7 million (2017: $246 .0 million; 2016: $182.0 million) of taxable losses that can be offset in the following nine years. The expiration dates of these Dutch losses is summarized in the following table. In the year ended December 31, 2018 unused tax losses of $20.0 million (December 31, 2017: $24.5 million) expired. 2019 2020 2021 2022 2023 in thousands Loss expiring $ 20,746 18,857 14,189 24,148 23,518 In the U.S., the tax act known as the Tax Cuts and Jobs Act (“the Act”) was enacted on December 22, 2017. The Act reduced the corporate tax rate from 35% to 21%, effective January 1, 2018. As a foreign domiciled entity, the most significant impact of the Act related to the tax rate applicable to the Company’s U.S. operating entity, resulting in a $1.7 million reduction of both the gross deferred tax asset and the valuation allowance in the year ended December 2017. In addition, the Act limits the utilization of tax losses incurred after January 1, 2018, to 80% of taxable income. The Company did not identify any further significant impacts related to the Act during 2018. The tax losses incurred prior to January 1, 2018 are approximately $55.1 million. As of December 31, 2018, the estimated remaining tax losses available for carry forward are $50.6 million. These losses will expire between 2034 and 2037. Under the provision of the Internal Revenue Code, the net operating loss may become subject to an annual limitation in the event of certain cumulative exchange in the ownership interest of significant shareholders over a three-year period in excess of 50 percent, as defined under Section 382 and 383 of the Internal Revenue Code. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation. There are no unrecognized tax benefits for the years ended December 31, 2018, 2017 and 2016. |
Basic and diluted earnings per
Basic and diluted earnings per share | 12 Months Ended |
Dec. 31, 2018 | |
Basic and diluted earnings per share | |
Basic and diluted earnings per share | 14. Basic and diluted earnings per share Diluted earnings per share is calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potentially dilutive ordinary shares. As the Company has incurred a loss in the years presented, all potentially dilutive ordinary shares would have an antidilutive effect, if converted, and thus have been excluded from the computation of loss per share. The potentially dilutive ordinary shares are summarized below: Years ended December 31, 2018 2017 2016 ordinary shares BMS warrants 8,575,000 6,800,000 3,587,333 Stock options under 2014 Plan and Nasdaq inducement rules 2,673,712 2,456,433 2,000,266 Non-vested RSUs and earned PSUs 789,490 1,194,737 418,627 Stock options under 2012 Plan 32,567 72,818 483,006 Warrants 37,175 37,175 37,175 Employee share purchase plan 1,012 — — Total potential dilutive ordinary shares 12,108,956 10,561,163 6,526,407 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2018 | |
Leases | |
Leases | 15. Leases The Company leases various office space and laboratory space under operating lease agreements: Lexington, Massachusetts / United States In July 2013, uniQure entered into a lease for a facility in Lexington, Massachusetts, United States. The term of the lease commenced in November 2013, was set for 10 years and is non-cancellable. Originally, the lease for this facility had a termination date of 2024. In November 2018, the term was expanded by five years to June 2029. The lease continues to be renewable for two subsequent five-year terms. Additionally, the lease was expanded to include an additional 30,655 square feet within the same facility and for the same term. The original lease provides for annual minimum increases in rent through 2024, based on a consumer price index. The lease then resets to the same rate schedule as the expansion space. Amsterdam / The Netherlands In March 2016, the Company entered into a 16-year lease for a facility in Amsterdam, the Netherlands and amended this agreement in June 2016. The Company consolidated its three Amsterdam sites into the new site at the end of May 2017. The lease for the new facility terminates in 2032, with an option to extend in increments of five-year periods. The lease contract provides for annual minimum increases in rent, based on a consumer price index On December 1, 2017, the Company entered into an agreement to sub-lease three of the seven floors of its Amsterdam facility for a ten-year term ending on December 31, 2027, with an option for the sub-lessee to extend until December 31, 2031. The minimum rentals to be received during the remaining nine-year term amount to $9.5 million as of December 31, 2018. As of December 31, 2018, aggregate minimum lease payments (excluding payments from the sub-lease agreement) for the calendar years and lease incentives received were as follows: Lexington Amsterdam Total in thousands 2019 $ 2,707 $ 1,963 $ 4,670 2020 3,360 1,970 5,330 2021 3,455 1,970 5,425 2022 3,552 1,970 5,522 2023 3,650 1,970 5,620 Thereafter 24,892 16,085 40,977 Total minimum lease payments $ 41,616 $ 25,926 $ 67,544 Deferred rent related to lease incentives-non current $ 4,974 $ 3,787 $ 8,761 Deferred rent related to lease incentives-current — 311 311 Rent expense is calculated on a straight-line basis over the term of the lease, and considers $12.2 million of lease incentives received. Aggregate rent expense was as follows: Years ended December 31, 2018 2017 2016 Rent expense-Lexington $ 1,583 $ 1,103 $ 1,103 Rent expense-Amsterdam 1,667 2,503 2,871 Total rent expense $ 3,250 $ 3,606 $ 3,974 |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and contingencies | |
Commitments and contingencies | 16. Commitments and contingencies In the course of its business, the Company enters as a licensee into contracts with other parties with regard to the development and marketing of its pipeline products. Among other payment obligations, the Company is obligated to pay royalties to the licensors based on future sales levels and milestone payments whenever specified development, regulatory and commercial milestones are met. As both future sales levels and the timing and achievement of milestones are uncertain, the financial effect of these agreements cannot be estimated reliably. |
Related party transaction
Related party transaction | 12 Months Ended |
Dec. 31, 2018 | |
Related party transaction | |
Related party transaction | 17. Related party transaction On June 13, 2018, the Company shareholders voted to approve the appointment of Robert Gut, M.D., Ph.D. as a non-executive director on our Board of Directors. On August 20, 2018, Dr. Gut was appointed as the Company’s Chief Medical Officer following his resignation as a non-executive director. On October 24, 2018, at an extraordinary general meeting, the Company’s shareholders voted to approve the appointment of Dr. Gut as executive director on the Board of Directors. Dr. Gut’s annual base salary will be $425,000 and he will be eligible for an annual bonus of 40% of his base salary. Dr. Gut was granted 35,000 restricted stock units vesting in equal installments over three years as well as an option to purchase 70,000 ordinary shares of the Company that will vest over a period of four years. In addition, Dr. Gut retains his option to purchase 10,000 ordinary shares vesting over three years, which he was granted upon his appointment as a non-executive director in June 2018. On August 7, 2017, the Company appointed Dr. Sander van Deventer as its Chief Scientific Officer and General Manager of its Amsterdam site. Dr. van Deventer served on the Company’s Board of Directors until September 14, 2017. Dr. van Deventer has resigned as Managing Partner of Forbion Capital Partners, and became an Operating Partner with Forbion Capital Partners for up to 50% of his time. Dr. van Deventer is entitled to €200,000 gross annual salary (“Base Salary”), including an 8% holiday allowance to be paid annually in May based upon the previous year’s gross annual salary. Dr. van Deventer will also be eligible for a bonus amounting to a maximum of 40% of his annual gross salary, such amount to be determined by the Board of Directors. On September 20, 2017, Dr. van Deventer was granted an option to purchase 150,000 shares with an exercise price of $8.49, in accordance with the Company’s Amended and Restated 2014 Share Incentive Plan. |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent events | |
Subsequent events | 18. Subsequent events None. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Summary of significant accounting policies | |
Basis of preparation | 2.1 Basis of preparation The Company prepared its consolidated financial statements in compliance with generally accepted accounting principles in the U.S. (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The consolidated financial statements have been prepared under the historical cost convention, except for derivative financial instruments and contingent consideration, which are recorded at fair value through profit or loss. The consolidated financial statements are presented in U.S. dollars, except where otherwise indicated. Transactions denominated in currencies other than U.S. dollars are presented in the transaction currency with the U.S. dollar amount included in parenthesis, converted at the foreign exchange rate as of the transaction date. The consolidated financial statements presented have been prepared on a going concern basis based on the Company’s cash and cash equivalents as of December 31, 2018 and the Company’s budgeted cash flows for the twelve months following the issuance date. |
Use of estimates | 2.2 Use of estimates The preparation of consolidated financial statements, in conformity with U.S. GAAP and SEC rules and regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period. Estimates and assumptions are primarily made in relation to revenue recognition in the determination and measurement of performance obligations and assessment of the performance period over which license revenue is recognized, income taxes, including the realization of deferred tax assets, fair value of derivative financial instruments, share-based compensation, measurement of accrued expenses which have not yet been invoiced as of the balance sheet date and business combinations including contingent consideration payable. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate. |
Accounting policies | 2.3 Accounting policies The principal accounting policies applied in the preparation of these consolidated financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated. |
Consolidation | 2.3.1 Consolidation The consolidated financial statements comprise the financial statements of the Company and its subsidiaries. Subsidiaries are all entities over which the Company has a controlling financial interest either through variable interest or through voting interest. Currently, the Company has no involvement with variable interest entities. Inter-company transactions, balances, income and expenses on transactions between uniQure entities are eliminated in consolidation. Profits and losses resulting from inter-company transactions that are recognized in assets are also eliminated. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Company. |
Current versus non-current classification | 2.3.2 Current versus non-current classification The Company presents assets and liabilities in the consolidated balance sheets based on current and non-current classification. The term current assets is used to designate cash and other assets or resources commonly identified as those that are reasonably expected to be realized in cash or sold or consumed during the normal operating cycle of the business. The Company’s normal operating cycle is twelve months. All other assets are classified as non-current. The term current liabilities is used principally to designate obligations whose liquidation is reasonably expected to require the use of existing resources properly classifiable as current assets, or the creation of other current liabilities. Current liabilities are expected to be settled in the normal operating cycle. The Company classifies all other liabilities as non-current. Deferred tax assets and liabilities are classified as non-current assets and liabilities. |
Foreign currency translation | 2.3.3 Foreign currency translation The functional currency of the Company and each of its entities (with the exception of uniQure Inc.) is the euro (€). This represents the currency of the primary economic environment in which the entities operate. The functional currency of uniQure Inc. is the U.S. dollar. The consolidated financial statements are presented in U.S. dollars. Foreign currency transactions are measured and recorded in the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the re-measurement of monetary assets and liabilities denominated in foreign currencies at exchange rates prevailing at balance sheet date are recognized in profit and loss. Upon consolidation, the assets and liabilities of foreign operations are translated into the functional currency of the shareholding entity at the exchange rates prevailing at the balance sheet date; items of income and expense are translated at monthly average exchange rates. The consolidated assets and liabilities are translated from uniQure N.V.’s functional currency, euro, into the reporting currency U.S. dollar at the exchange rates prevailing at the balance sheet date; items of income and expense are translated at monthly average exchange rates. Issued capital and additional paid-in capital are translated at historical rates with differences to the balance sheet date rate recorded as translation adjustments in other comprehensive income / loss. The exchange differences arising on translation for consolidation are recognized in “accumulated other comprehensive income / loss”. On disposal of a foreign operation, the component of other comprehensive income / loss relating to that particular foreign operation is recognized in profit or loss. As the intercompany funding of the Company’s Lexington operations is neither planned nor likely to be settled in the foreseeable future, the associated foreign exchange effect is presented as accumulated other comprehensive income / loss. |
Fair value measurement | 2.3.4 Fair value measurement The Company measures certain assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. ASC 820, Fair Value Measurements and Disclosures , requires disclosure of methodologies used in determining the reported fair values, and establishes a hierarchy of inputs used when available. The three levels of the fair value hierarchy are described below: · Level 1 - Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. · Level 2 - Valuations based on quoted prices for similar assets or liabilities in markets that are not active or models for which the inputs are observable, either directly or indirectly. · Level 3 - Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and are unobservable. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Items measured at fair value on a recurring basis include financial instruments and contingent consideration (note 3, “Fair value measurement”). The carrying amount of cash and cash equivalents, accounts receivable from collaborators, prepaid expenses, other assets, accounts payable, accrued expenses and other current liabilities reflected in the consolidated balance sheets approximate their fair values due to their short-term maturities. |
Business combinations | 2.3.5 Business combination On July 31, 2014, the Company closed its acquisition of InoCard GmbH (“InoCard”). This transaction was accounted for as a business combination under the acquisition method of accounting. Accordingly, the tangible and intangible assets acquired and liabilities assumed were recorded at fair value as of the date of acquisition, with the excess purchase price recorded as goodwill. The estimated fair values of the assets acquired and liabilities assumed were determined using the methods discussed in the following paragraphs and required significant judgment and estimates, which could materially differ from actual values and fair values determined using different methods or assumptions. a. Goodwill Goodwill represents the excess of the purchase price over the fair value of the net assets acquired when accounted for using the acquisition method of accounting for business combinations. Goodwill is not amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis in the fourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s reporting unit below its carrying amount. The Company has not recognized any impairment charges related to goodwill. b. Acquired research and development Acquired research and development (“Acquired R&D”) represents the fair value assigned to intangible assets in incomplete research projects that the Company acquires through business combinations. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion, abandonment of the projects or when the research findings are commercialized through a revenue-generating project. Upon successful completion or commercialization of a project, uniQure will make a determination as to the then useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization. In case of abandonment, the asset will be written-off. See note 6, “Intangible assets,” for additional information. c. Contingent consideration Each reporting period, the Company revalues the contingent consideration obligations associated with this business combination to their fair value and records changes in the fair value within research and development expenses. Changes in contingent consideration result from changes in assumptions regarding the probabilities of successful achievement of related milestones, the estimated timing in which milestones are achieved and the discount rate used to estimate the fair value of the liability. Payments made soon after the acquisition date are recorded as cash flows from financing activities, and payments, or the portion of the payments, not made soon after the acquisition date are recorded as cash flows from operating activities. See note 3, “Fair value measurement,” for additional information. |
Notes to the consolidated statements of cash flows | 2.3.6 Notes to the consolidated statements of cash flows The consolidated statements of cash flows have been prepared using the indirect method. The cash disclosed in the consolidated statements of cash flows is comprised of cash and cash equivalents. Cash and cash equivalents include bank balances, demand deposits and other short-term highly liquid investments (with maturities of less than three months at the time of purchase) that are readily convertible into a known amount of cash and are subject to an insignificant risk of fluctuation in value. Cash flows denominated in foreign currencies have been translated at the average exchange rates. Exchange differences, if any, affecting cash and cash equivalents are shown separately in the consolidated statements of cash flows. Interest paid and received, and income taxes are included in net cash (used in) provided by operating activities. |
Segment information | 2.3.7 Segment information Operating segments are identified as a component of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as one operating segment, which comprises the discovery, development and commercialization of innovative gene therapies. |
Net loss per share | 2.3.8 Net loss per share The Company follows the provisions of ASC 260, Earnings Per Share . In accordance with these provisions, loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share reflects the dilution that would occur if share options or warrants to issue common stock were exercised, or performance or restricted share units were distributed. However, potential common shares are excluded if their effect is anti-dilutive. The Company currently has no dilutive securities due to the net loss position and as such, basic and diluted net loss per share are the same for the periods presented. |
Impairment of long-lived assets | 2.3.9 Impairment of long-lived assets Long-lived assets, which include property, plant, and equipment and finite-lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying value of an asset or asset group may not be recoverable. The recoverability of the carrying value of an asset or asset group depends on the successful execution of the Company’s business initiatives and its ability to earn sufficient returns on approved products and product candidates. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the future undiscounted cash flows are less than the carrying amount of these assets, the Company recognizes an impairment loss based on the excess of the carrying value over the fair value of the assets. Fair value is determined through various valuation techniques, including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary. Goodwill is not amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis, during the fourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s reporting unit below its carrying amount. The Company performs the same quantitative analysis discussed above for long-lived assets and finite-lived intangible assets. |
Intangible assets | 2.3.10 Intangible assets Acquired licenses have a finite useful life and are carried at cost less accumulated amortization and impairment losses. Amortization is calculated using the straight-line method to allocate the cost of licenses over their estimated useful lives (generally 20 years unless a license expires prior to that date). |
Property, plant and equipment | 2.3.11 Property, plant and equipment Property, plant and equipment is comprised mainly of laboratory equipment, leasehold improvements, construction-in-progress (“CIP”) and office equipment. All property, plant and equipment is stated at cost less accumulated depreciation. CIP consists of capitalized expenses associated with construction of assets not yet placed into service. Depreciation commences on CIP once the asset is placed into service based on its useful life determined at that time. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed as incurred. Upon disposal, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss on the transaction is recognized in the consolidated statements of operations and comprehensive loss. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets (or in the case of leasehold improvements a shorter lease term), which are as follows: Leasehold improvements Between 10 – 15 years Laboratory equipment 5 years Office equipment Between 3 – 5 years |
Other (non) current assets | 2.3.12 Other (non) current assets Deposit paid are either presented as other current assets or as other non-current assets based on duration of the underlying contractual arrangement. Deposits are classified as restricted cash and primarily relate to facility leases. |
Accounts receivables | 2.3.13 Accounts receivable Accounts receivables are amounts due from services provided to the Company’s collaboration partner and are purely trade receivables. |
Prepaid expenses | 2.3.14 Prepaid expenses Prepaid expenses are amounts paid in the period, for which the benefit has not been realized, and include payments made for insurance and research contracts. The related expense will be recognized in the subsequent period as incurred. |
Accounts payable and accrued expenses | 2.3.15 Accounts payable and accrued expenses Accounts payables are invoiced amounts related to obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts payables are recognized at the amounts invoiced by suppliers. Accrued expenses are recognized for goods or services that have been acquired in the ordinary course of business. |
Long-term debt | 2.3.16 Long-term debt Long-term debt is initially recognized at cost and presented net of original issue discount or premium and debt issuance costs on the consolidated balance sheets. Amortization of debt discount and debt issuance costs is recognized as interest expense in profit and loss over the period of the debt, using the effective interest rate method. |
Pensions and other post-retirement benefit plans | 2.3.17 Pensions and other post-retirement benefit plans The Company has a defined contribution pension plan for all employees at its Amsterdam facility in the Netherlands, which is funded by the Company through payments to an insurance company, with individual accounts for each participants’ assets. The Company has no legal or constructive obligation to pay further contributions if the plan does not hold sufficient assets to pay all employees the benefits relating to services rendered in the current and prior periods. The contributions are expensed as incurred. Prepaid contributions are recognized as an asset to the extent that a cash refund or a reduction in the future payments is available. Starting in 2016, the Company adopted a qualified 401(k) Plan for all employees at its Lexington facility in the USA, which offers both a pre-tax and post-tax (Roth) component. Employees may contribute up to 50% of their pre-tax compensation, which is subject to IRS statutory limits for each calendar year. The Company matches $0.50 for every $1.00 contributed to the plan by participants up to 6% of base compensation. Employer contributions are recognized as they are contributed, as long as the employee is rendering services in that period. If employer contributions are made in periods after an individual retires or terminates, the estimated cost is accrued during the employee’s service period. |
Share-based compensation | 2.3.18 Share-based compensation The Company accounts for its share-based compensation awards in accordance with ASC 718, Compensation-Stock Compensation and ASC Subtopic 505-50, Equity-Based Payments to Non-Employees . All of the Company’s share-based compensation plans for employees are equity-classified. ASC 718 requires all share-based compensation to employees, including grants of employee options, restricted share units, performance share units and modifications to existing instruments, to be recognized in the consolidated statements of operations and comprehensive loss based on their grant-date fair values, net of an estimated forfeiture rate, over the requisite service period. Forfeitures of employee options are recognized as they occur. ASC 505-50 requires all share-based compensation to non-employees to be recognized in the consolidated statements of operations and comprehensive loss based on their fair values, with the fair values being re-measured until completion of performance. The Company uses a Hull & White option model to determine the fair value of option awards. The model captures early exercises by assuming that the likelihood of exercises will increase when the share-price reaches defined multiples of the strike price. This analysis is performed over the full contractual term. |
Revenue recognition | 2.3.19 Revenue recognition The Company primarily generates revenue from its collaboration, research and license agreements with its collaboration partners for the development and commercialization of its product candidates. Revenue recognition in accordance with ASC 606: On January 1, 2018 the Company adopted new revenue recognition policies in accordance with ASC 606 using the modified retrospective approach. The new revenue recognition policies replace the revenue recognition standards under ASC 605. The Company elected to implement ASC 606 by applying it to active collaboration arrangements as of the Initial Application Date and to record a cumulative adjustment of revenue previously recognized to accumulated loss as of December 31, 2017. See note 2.3.23 “Recently Adopted Accounting Pronouncements” and note 4 “Collaboration” for additional information. Revenue recognition for the years ended 2017 and 2016: During the years ended December 31, 2017 and 2016 the Company applied ASC 605. The Company recognized revenue when earned and realized or realizable. Accordingly, revenue was recognized for each unit of accounting when all of the following criteria were met: · Persuasive evidence of an arrangement exists; · Delivery has occurred or services have been rendered; · The seller´s price to the buyer is fixed or determinable; · Collectability is reasonably assured. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s consolidated balance sheets. Multiple element arrangements were analyzed to determine whether the deliverables within the agreement can be separated or whether they must be accounted for as a single unit of accounting. Deliverables under an agreement are required to be accounted for as separate units of accounting provided that (i) a delivered item has value to the customer on a stand-alone basis; and (ii) if the agreement includes a general right of return relative to the delivered item, the delivery or performance of the undelivered item is considered probable and substantially in the control of the vendor. The allocation of consideration amongst the deliverables under the agreement is derived using a “best estimate of selling price” if vendor specific objective evidence and third-party evidence of fair value are not available. If the delivered element does not have stand-alone value or if the fair value of any of the undelivered elements cannot be determined, the arrangement is accounted for as a single unit of accounting. a. License revenues under ASC 605 License revenues consisted of up-front payments, target selection payments, milestone payments and royalties. Up-front and target selection payments Up-front payments, target selection payments or similar non-refundable payments were initially reported as deferred revenue on the consolidated balance sheets and were recognized as revenue on a straight-line basis over the period of the performance obligation. The estimated period of the performance obligation is re-assessed at each balance sheet date. Milestone payments and royalties Research-based milestone payments were recognized as revenues either on achievement of such milestones if the milestones were considered substantive or over the period the Company has continuing performance obligations, if the milestones were not considered substantive. When determining if a milestone is substantive, the Company considered the following factors: · The degree of certainty in achieving the milestone; · The frequency of milestone payments; · The Company’s efforts, which result in achievement of the milestone; · The amount of the milestone payment relative to the other deliverables and payment terms; and · Whether the milestone payment is related to future performance or deliverables. Sales-based milestone payments and royalties were recognized in earnings when earned. b. Collaboration revenue under ASC 605 Collaboration revenue consists of revenue generated from collaborative research and development arrangements. Services may include the provision of Company staff, consultants or other third-party vendors engaged by the Company in relation to a collaboration program and the manufacturing of gene therapeutic products to the extent these were reimbursed through the respective collaborative research and development program. Collaboration revenues, which were related to reimbursements from collaborators for the Company’s performance of research and development services under the respective agreements, were recognized on the basis of labor hours valued at a contractually agreed rate. Collaboration revenues include reimbursements for related out-of-pocket expenses. Cost reimbursements to which the Company was entitled under agreements were recognized as collaboration revenues in the same quarter of the recorded cost they were intended to compensate. |
Other income, other expense | 2.3.20 Other income, other expense The Company receives certain government and regional grants, which support its research efforts in defined projects, and include contributions towards the cost of research and development. These grants generally provide for reimbursement of approved costs incurred as defined in the respective grants and are deferred and recognized in the statements of operations and comprehensive loss over the period necessary to match them with the costs they are intended to compensate, when it is probable that the Company has complied with any conditions attached to the grant and will receive the reimbursement. The Company’s other income also consists of income from the subleasing of the Amsterdam facility while other expense consists of expenses incurred in relation to the subleasing income. Income from releasing outstanding deferred revenue in relation to the termination of the collaboration with Chiesi Cost incurred in 2017 in relation to terminating the marketing of its Glybera program, as well as costs associated with exiting its prior Amsterdam facilities and its Heidelberg site are presented as other expenses |
Research and development expenses | 2.3.21 Research and development expenses Research and development costs are expensed as incurred. Research and development expenses generally consist of laboratory research, clinical trials, statistical analysis and report writing, regulatory compliance costs incurred with clinical research organizations and other third-party vendors (including post-approval commitments to conduct consistency and comparability studies). In addition, research and development expenses consist of start-up and validation costs related to the Company’s Lexington facility and the development and improvement of the Company’s manufacturing processes and methods. |
Income taxes | 2.3.22 Income taxes Income taxes are recorded in accordance with ASC 740, Income Taxes , which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more-likely-than-not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more-likely-than-not be realized. The determination as to whether the tax benefit will more-likely-than-not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2018, and 2017, the Company did not have any significant uncertain tax positions. |
Recent accounting pronouncements | 2.3.23 Recently Adopted Accounting Pronouncements ASU 2014-09: ASC 606 Revenue from Contracts with Customers Effective January 1, 2018 the Company adopted new revenue recognition policies in accordance with ASC 606 using the modified retrospective approach. The new revenue recognition policies replace the revenue recognition standards under ASC 605. The Company elected to implement ASC 606 by applying it to active collaboration arrangements as of January 1, 2018 and to record a cumulative adjustment of revenue previously recognized to the accumulated loss as of December 31, 2017. The impact of implementing ASC 606 is summarized below: - Recognized $7.5 million of license revenue during the twelve months ended December 31, 2018, related to the collaboration with BMS compared to $4.2 million that would have been recognized in accordance with the previous revenue recognition policies; - Continued to present revenue recognized during the twelve months ended December 31, 2017 and December 31, 2016, in accordance with the previous revenue recognition policies; - Decreased the accumulated loss by $24.9 million as of January 1, 2018 and decreased deferred revenue as of the same date by $24.9 million. In accordance with the previous revenue recognition policies the Company had concluded that the BMS collaboration agreement consisted of three performance obligations, (i) technology (license and target selections), know‑how and manufacturing in the field of gene therapy and development and active contribution to the development through the joint steering committee participations, (ii) provision of employees, goods and services for research, and (iii) clinical and commercial manufacturing. The Company determined that these three performance obligations are substantially identical with the performance obligations in accordance with its new revenue recognition policies: (i) Providing access to its technology and know-how in the field of gene therapy as well as actively contributing to the target selection, the collaboration as a whole, the development during the target selection, the pre-clinical and the clinical phase through participating in joint steering committee and other governing bodies (“License Revenue”); (ii) Providing pre-clinical research activities (“Collaboration Revenue”); and (iii) Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”). License Revenue The Company previously recognized License Revenue over the expected performance period on a straight-line basis commencing on May 21, 2015. The Company now recognizes License Revenue over the expected performance period based on its progress toward the completion of its services (see note 4 for a detailed discussion). Collaboration and Manufacturing Revenue The adoption of the new revenue recognition policies did not materially impact the recognition of Collaboration or Manufacturing Revenue. ASU 2016-01: ASC 825 Recognition and Measurement of Financial Assets and Financial Liabilities In January 2016, the FASB issued ASU 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”). ASU 2016-01 addresses certain aspects of recognition, measurement, presentation and disclosure of financial instruments. ASU 2016-01 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, which for the Company was January 1, 2018. ASU 2016-01 did not have a material impact on our consolidated financial statements. ASU 2016-05: Derivatives and Hedging: Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships In March 2016, the FASB issued ASU 2016-05, Derivatives and Hedging: Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships (“ASU 2016-05”) and ASU 2016-06, Derivatives and Hedging: Contingent Put and Call Options in Debt Instruments. Both ASUs address issues regarding hedge accounting. The ASUs are effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, which for the Company was January 1, 2018. Neither ASU 2016-05 nor ASU 2016-06 had a material impact on our consolidated financial statements. ASU 2017-09: Compensation (topic 718)- scope of modification accounting In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (topic 718)- Scope of Modification Accounting (“ASU 2017-09”), which provides clarity regarding the applicability of modification accounting in relation to share-based payment awards. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The effective date for the standard is for fiscal years beginning after December 15, 2017, which for the Company was January 1, 2018. The new standard was to be applied prospectively. ASU 2017-09 did not have a material impact on our consolidated financial statements. Recent Accounting Pronouncements Not Yet Effective ASU 2016-02: Leases In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). In July 2018, the FASB issued ASU No. 2018-10, “Codification Improvements to Topic 842, Leases” (ASU 2018-10), which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU No. 2018-11, “Leases (Topic 842) - Targeted Improvements” (ASU 2018-11), which addresses implementation issues related to the new lease standard. Under the new guidance, lessees will be required to recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. Lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. ASU 2016-02 will be effective for the Company beginning in the first quarter of 2019 and early application is permitted. The Company is finalizing its evaluation of the impact of adopting this standard including finalizing the population of leases which mainly consist of the lease agreements for the buildings. The Company expects ASU 2016-02 to have a material impact on its consolidated financial statements, primarily from recognition of a right-of-use asset and lease liability in the balance sheet. The lease liability will be measured at the present value of the lease payments not yet paid discounted using the discount rate for the lease established at commencement date. The right-of-use asset will be valued at the amount of the lease liability adjusted for prepaid or accrued lease payments and the remaining balance of any lease incentives received. See Note 15, “Leases,” for current leases identified that will be impacted by the standard. Lease cost will continue to be recognized on a straight-line basis within income from continuing operations. Payments arising from operating leases will be classified within operating activities. ASU 2018-13: Fair Value Measurement In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) which modifies the disclosure requirements on fair value measurements. The effective date for the standard is fiscal years beginning after December 15, 2019, which for the Company is January 1, 2020. Early adoption is permitted. The new disclosure requirements for changes in unrealized gains and losses in other comprehensive income for recurring Level 3 measurements, the range and weighted average of significant unobservable inputs and the amended requirements for the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively. The Company does not expect ASU 2018-13 to have a material impact on our consolidated financial statements |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Summary of significant accounting policies | |
Schedule of estimated useful lives of depreciable property, plant and equipment | Leasehold improvements Between 10 – 15 years Laboratory equipment 5 years Office equipment Between 3 – 5 years |
Fair value measurement (Tables)
Fair value measurement (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair value measurement | |
Schedule of changes in Level 3 items | Derivative Contingent financial consideration instruments Total in thousands Balance at December 31, 2015 $ 2,926 $ 837 $ 3,763 Gains recognized in profit or loss (1,080) (785) (1,865) Currency translation effects (8) 10 2 Balance at December 31, 2016 $ 1,838 $ 62 $ 1,900 Exercises of convertible loan warrants — (631) (631) Losses recognized in profit or loss 3,002 2,192 5,194 Contingent consideration paid (1,181) — (1,181) Currency translation effects 305 12 317 Balance at December 31, 2017 $ 3,964 $ 1,635 $ 5,599 Gains recognized in profit or loss (3,846) (208) (4,054) Currency translation effects (118) (52) (170) Balance at December 31, 2018 $ — $ 1,375 $ 1,375 |
Schedule of changes in fair value of unobservable inputs related to collaboration arrangement | Total warrants in thousands Base case $ 803 Increase volatility by 10% to 85% 236 Extend exercise dates by one year 55 |
Collaboration arrangements an_2
Collaboration arrangements and concentration of credit risk (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Collaboration arrangements and concentration of credit risk | |
Schedule of collaboration and license revenue | Years ended December 31, 2018 2017 2016 in thousands Bristol Myers Squibb $ 11,284 $ 8,461 $ 16,959 Chiesi Farmaceutici S.p.A (terminated in 2017) — 4,646 8,139 Total $ 11,284 $ 13,107 $ 25,098 |
Schedule of amounts owed in relation to collaboration | December 31, December 31, 2018 2017 in thousands Bristol Myers Squibb $ 233 $ 1,586 Total $ 233 $ 1,586 |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, plant and equipment, net | |
Schedule of property, plant and equipment | December 31, December 31, 2018 2017 in thousands Leasehold improvements $ 32,462 $ 32,297 Laboratory equipment 16,685 15,976 Office equipment 2,853 2,304 Construction-in-progress 73 745 Total property, plant, and equipment 52,073 51,322 Less accumulated depreciation (22,894) (17,041) Property, plant and equipment, net $ 29,179 $ 34,281 |
Summary of long-lived assets by geographic region | December 31, December 31, 2018 2017 in thousands Lexington, Massachusetts (United States of America) $ 14,598 $ 17,177 Amsterdam (the Netherlands) 14,581 17,104 Total $ 29,179 $ 34,281 |
Intangible assets (Tables)
Intangible assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Intangible assets | |
Schedule of finite-lived intangible assets | December 31, December 31, 2018 2017 in thousands Licenses $ 7,528 $ 9,551 Less accumulated amortization and impairment (2,327) (5,575) Licenses, net $ 5,201 $ 3,976 Acquired research and development — 5,594 Intangible assets, net $ 5,201 $ 9,570 |
Schedule of estimated future amortization expense | Years Amount in thousands 2019 $ 471 2020 471 2021 462 2022 433 2023 433 Thereafter 2,931 Total $ 5,201 |
Schedule of acquired licenses | December 31, December 31, 2018 2017 in thousands Protein Sciences Corporation $ 2,084 $ 2,340 St. Jude Children’s Hospital 633 707 Other 2,484 929 Total $ 5,201 $ 3,976 |
Accrued expenses and other (n_2
Accrued expenses and other (non) current liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accrued expenses and other (non) current liabilities | |
Schedule of accrued expenses and other current liabilities | December 31, December 31, 2018 2017 in thousands Accruals for services provided by vendors-not yet billed $ 1,999 $ 2,348 Personnel related accruals and liabilities 5,688 5,646 Other current liabilities 545 844 Total $ 8,232 $ 8,838 |
Schedule of change in accrual of termination benefits | Accrued termination benefits in thousands Balance at December 31, 2017 $ 625 Accrued through operations 96 Payments (725) Currency translation effects 4 Balance at December 31, 2018 $ — |
Long-term debt (Tables)
Long-term debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Long-term debt | |
Schedule of interest expense | Years Amount in millions 2018 $ 2.0 2017 2.2 2016 2.2 |
Schedule of aggregate maturities of the loan | Years Amount in thousands 2019 $ 3,119 2020 4,119 2021 15,657 2022 15,657 2023 9,625 Total $ 48,177 |
Share-based compensation (Table
Share-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Share-based compensation | |
Schedule of share-based compensation expense by classification included in consolidated statements of operations and comprehensive loss | Years ended December 31, 2018 2017 2016 Research and development - employees $ 3,994 $ 3,945 $ 3,302 Selling, general and administrative - employees 6,699 6,335 2,242 Research and development - non-employees — — 670 Total $ 10,693 $ 10,280 $ 6,214 |
Schedule of share-based compensation expense | Years ended December 31, 2018 2017 2016 Award type Share options $ 4,766 $ 3,246 $ 5,187 Restricted share units (“RSUs”) 3,020 2,588 528 Performance share units (“PSUs”) 2,907 4,446 499 Total $ 10,693 $ 10,280 $ 6,214 |
Schedule of unrecognized compensation cost related to unvested awards | Weighted-average Unrecognized remaining compensation period for costs recognition Award type in thousands in years Share options $ 14,489 3.13 Restricted share units 4,055 2.12 Performance share units 4,934 1.62 Total $ 23,478 2.64 |
Schedule of weighted-average assumptions for fair value of option issued | Years ended December 31, Assumptions 2018 2017 2016 Expected volatility 75%-80% 75%-80% 75% Expected terms (in years) 10 years 10 years 10 years Risk free interest rate 2.67% - 3.20% 2.39% - 2.81% 0.16% - 2.67% Expected dividends 0% 0% 0% |
Summary of RSUs activity | RSU Weighted average grant-date fair Number of shares value Non-vested at December 31, 2017 683,663 $ 6.38 Granted 262,599 $ 23.61 Vested (341,833) $ 6.43 Forfeited (192,108) $ 8.15 Non-vested at December 31, 2018 412,321 $ 16.49 Total weighted average grant date fair value of RSUs granted during 2018 (in millions) $ 6.2 Granted to directors and officers during 2018 (shares, $ in millions) 133,808 $ 3.3 |
Summary of PSUs activity | PSU Weighted average grant-date fair Number of shares value Non-vested at December 31, 2017 511,074 $ 16.73 Granted — $ — Vested (68,115) $ 15.79 Forfeited (65,790) $ 17.44 Non-vested at December 31, 2018 377,169 $ 16.73 PSUs awarded but not yet earned 136,982 $ 28.82 Total non-vested and discretionary PSUs 514,151 $ 19.95 Total weighted average grant date fair value of PSUs awarded during the period (in millions) $ 3.9 |
2014 Plan | |
Share-based compensation | |
Summary of option activity | Weighted average Weighted average Aggregate intrinsic Options exercise price remaining contractual life value in years in thousands Outstanding at December 31, 2017 2,456,433 $ 10.06 7.98 $ 24,213 Granted 937,832 $ 26.18 Forfeited (315,342) $ 13.27 Expired (17,008) $ 17.87 Exercised (388,203) $ 11.48 Outstanding at December 31, 2018 2,673,712 $ 15.09 7.98 39,616 Fully vested and exercisable at December 31, 2018 1,073,915 $ 10.80 6.90 19,348 Outstanding and expected to vest at December 31, 2018 1,599,797 $ 17.96 8.70 20,268 Outstanding and expected to vest at December 31, 2017 1,680,491 $ 8.62 Total weighted average grant date fair value of options issued during 2018 (in $ millions) $ 14.9 Granted to directors and officers during 2018 (options, $ in millions) 315,156 $ 4.7 Proceeds from option sales during 2018 (in $ millions) $ 4.5 |
Summary of information about weighted average grant-date fair value of options granted | Weighted average Options grant‑date fair value Granted, 2018 937,832 $ 15.90 Granted, 2017 1,295,350 3.87 Granted, 2016 1,024,178 6.67 Vested, 2018 689,892 5.08 Forfeited, 2018 (315,342) 7.96 |
Summary of summarizes information about the weighted average grant-date fair value of options outstanding and expected to vest | Weighted average Options grant‑date fair value Outstanding and expected to vest, 2018 1,599,797 $ 10.83 Outstanding and expected to vest, 2017 1,680,491 5.06 |
Summary of information about options exercised | Exercised during the year Intrinsic value in thousands 2018 388,203 $ 7,515 2017 198,552 1,291 2016 239,861 3,039 |
2012 Plan | |
Share-based compensation | |
Summary of option activity | 2012 plan Weighted average Weighted average Aggregate intrinsic Options exercise price remaining contractual life value in years in thousands Outstanding at December 31, 2017 72,818 € 5.77 3.00 $ 922 Exercised (40,251) € 6.21 Forfeited — € — Expired — € — Outstanding, fully vested and exercisable at December 31, 2018 32,567 € 5.23 3.62 939 Proceeds from option sales (in million) $ 0.3 |
Summary of information about options exercised | Exercised during the year Intrinsic value in thousands 2018 40,251 $ 964 2017 405,188 1,176 2016 510,547 4,381 |
Restricted share units ("RSUs") | |
Share-based compensation | |
Summary of information about weighted average grant-date fair value of options granted | Granted Weighted average during the year grant‑date fair value 2018 262,599 $ 23.61 2017 603,350 5.86 2016 358,678 9.05 |
Summary of information about the total fair value of stock that vested | Total fair value in thousands 2018 $ 8,546 2017 2,917 2016 2,296 |
Performance share units ("PSUs") | |
Share-based compensation | |
Summary of information about weighted average grant-date fair value of options granted | Granted Weighted average during the year grant‑date fair value 2018 — $ — 2017 550,570 $ 17.15 2016 111,564 $ 5.76 |
Summary of information about the total fair value of stock that vested | Total fair value in thousands 2018 $ 1,350 2017 1,730 2016 N/A |
Expenses by nature (Tables)
Expenses by nature (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Expenses by nature | |
Schedule of operating expenses | Years ended December 31, 2018 2017 2016 in thousands Employee-related expenses $ 46,254 $ 46,373 $ 42,260 Laboratory and development expenses 23,596 17,737 21,054 Office and housing expenses 7,281 9,327 10,384 Legal and advisory expenses 7,748 8,121 11,715 Depreciation, amortization and impairment expenses 12,415 6,779 6,089 Patent and license expenses 1,202 817 1,348 Non-employee share-based compensation expenses — — 670 Other operating expenses 1,618 7,653 4,989 Total $ 100,114 $ 96,807 $ 98,509 |
Schedule of employee-related expenses | Years ended December 31, 2018 2017 2016 in thousands, except for employee numbers Wages and salaries $ 26,646 $ 25,131 $ 24,999 Share-based compensation expenses 10,708 10,280 5,544 Consultant expenses 2,974 4,758 5,873 Social security costs 2,231 2,077 1,824 Health insurance 1,750 1,536 1,099 Pension costs-defined contribution plans 628 802 1,088 Other employee expenses 1,317 1,789 1,833 Total $ 46,254 $ 46,373 $ 42,260 Number of employees at the end of the period 212 202 251 |
Other non-operating income _ _2
Other non-operating income / (expense) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Other non-operating income / (expense) | |
Schedule of other non-operating income / (expense) | Years ended December 31, 2018 2017 2016 in thousands Other non-operating income: Derivative gains $ 208 $ — $ 785 Total other non-operating income: 208 — 785 Other non-operating expense: Derivative losses — (2,192) — Finance expenses — (243) — Total other non-operating expense: — (2,435) — Other non-operating income / (expense), net $ 208 $ (2,435) $ 785 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income taxes | |
Schedule of loss before income taxes | Years ended December 31, 2018 2017 2016 in thousands Dutch operations $ (85,721) $ (60,966) $ (51,107) U.S. operations 2,646 (18,493) (21,221) Foreign operations 3 — 99 Total $ (83,073) $ (79,459) $ (72,229) |
Schedule of income tax benefit / (expense) | Years ended December 31, 2018 2017 2016 in thousands Current benefit / (expense) Dutch operations $ — $ — $ — U.S. operations — — — Foreign operations (22) (10) (51) Deferred benefit / (expense) Dutch operations (209) 209 (1,094) U.S. operations — — — Foreign operations — — — Total income tax benefit / (expense) $ (231) $ 199 $ (1,145) |
Schedule of reconciliation of statutory income tax rate to effective tax rate | Years ended December 31, 2018 2017 2016 in thousands Net loss before tax for the period $ (83,073) $ (79,459) $ (72,229) Expected tax benefit / (expense) at the tax rate enacted in the Netherlands (25%) 20,768 19,865 18,057 Difference in tax rates between the Netherlands and foreign countries (106) 1,664 1,905 Net change in valuation allowance (19,207) (17,358) (20,054) Non-deductible expenses (2,648) (3,248) (1,323) Change in fair value of contingent consideration 962 (724) 270 Income tax benefit / (expense) $ (231) $ 199 $ (1,145) |
Schedule of significant portions of deferred tax assets and deferred tax liabilities | Years ended December 31, 2018 2017 in thousands Deferred tax assets: Net operating loss carryforwards $ 74,529 $ 73,207 Intangible assets 847 924 Property, plant and equipment 561 173 Deferred revenue 7,481 17,930 Accrued expenses and other current liabilities 1,682 1,657 Gross deferred tax asset $ 85,100 $ 93,891 Less valuation allowance (85,100) (93,682) Net deferred tax asset $ — $ 209 Long-term loan to foreign operations — (209) Net deferred tax liability $ — $ (209) Net deferred tax asset / (liability) $ — $ — |
Summary of Changes in the valuation allowance | Years ended December 31, 2018 2017 2016 in thousands January 1, $ 93,682 $ 82,642 $ 65,593 Changes related to reduction of deferred revenue recorded in equity upon implementation of ASC 606 Revenue recognition as of January 1, 2018 (6,229) — — Changes recorded in profit and loss 19,207 19,080 20,054 Reduction related to 2018 Dutch tax reform (15,670) — — Reduction related to 2017 US tax reform — (1,722) — Other changes including currency translation effects (5,890) (6,318) (3,005) December 31, $ 85,100 $ 93,682 $ 82,642 |
Summary of expiration dates for losses | 2019 2020 2021 2022 2023 in thousands Loss expiring $ 20,746 18,857 14,189 24,148 23,518 |
Basic and diluted earnings pe_2
Basic and diluted earnings per share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Basic and diluted earnings per share | |
Schedule of potential dilutive common shares | Years ended December 31, 2018 2017 2016 ordinary shares BMS warrants 8,575,000 6,800,000 3,587,333 Stock options under 2014 Plan and Nasdaq inducement rules 2,673,712 2,456,433 2,000,266 Non-vested RSUs and earned PSUs 789,490 1,194,737 418,627 Stock options under 2012 Plan 32,567 72,818 483,006 Warrants 37,175 37,175 37,175 Employee share purchase plan 1,012 — — Total potential dilutive ordinary shares 12,108,956 10,561,163 6,526,407 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Leases | |
Schedule of minimum lease payments | Lexington Amsterdam Total in thousands 2019 $ 2,707 $ 1,963 $ 4,670 2020 3,360 1,970 5,330 2021 3,455 1,970 5,425 2022 3,552 1,970 5,522 2023 3,650 1,970 5,620 Thereafter 24,892 16,085 40,977 Total minimum lease payments $ 41,616 $ 25,926 $ 67,544 Deferred rent related to lease incentives-non current $ 4,974 $ 3,787 $ 8,761 Deferred rent related to lease incentives-current — 311 311 |
Summary of aggregate rent expense | Years ended December 31, 2018 2017 2016 Rent expense-Lexington $ 1,583 $ 1,103 $ 1,103 Rent expense-Amsterdam 1,667 2,503 2,871 Total rent expense $ 3,250 $ 3,606 $ 3,974 |
Summary of significant accoun_4
Summary of significant accounting policies (Details) | 12 Months Ended | |||
Dec. 31, 2018USD ($)segment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Segment information | ||||
Number of operating segments | segment | 1 | |||
Other (non) current assets | ||||
Cash and cash equivalents | $ 234,898,000 | $ 159,371,000 | $ 132,496,000 | |
Restricted Cash | 2,444,000 | 2,480,000 | 1,828,000 | |
Total cash, cash equivalents and restricted cash | $ 237,342,000 | $ 161,851,000 | $ 134,324,000 | $ 222,869,000 |
401(k) Plan | Lexington | ||||
Pensions | ||||
Maximum annual employee contribution as a percent of pre-tax compensation | 50.00% | |||
Amount of employer matching contribution for every employee dollar contributed | $ 0.50 | |||
Minimum | ||||
Property, plant and equipment, net | ||||
Estimated useful life (in years) | P3Y | |||
Maximum | ||||
Property, plant and equipment, net | ||||
Estimated useful life (in years) | P5Y | |||
Maximum | 401(k) Plan | Lexington | ||||
Pensions | ||||
Percent of employee gross pay for which the employer makes a matching contribution | 6.00% | |||
Leasehold improvements | Minimum | ||||
Property, plant and equipment, net | ||||
Estimated useful life (in years) | P10Y | |||
Leasehold improvements | Maximum | ||||
Property, plant and equipment, net | ||||
Estimated useful life (in years) | P15Y | |||
Laboratory equipment | ||||
Property, plant and equipment, net | ||||
Estimated useful life (in years) | P5Y | |||
Licenses | ||||
Property, plant and equipment, net | ||||
Estimated useful life (in years) | P20Y |
Summary of significant accoun_5
Summary of significant accounting policies - Recently Adopted Accounting Pronouncements (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Revenue | $ 11,284 | $ 13,107 | $ 25,098 |
Accumulated loss | (535,506) | (475,318) | |
ASU 2014-09 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Accumulated loss | (24,900) | ||
Deferred Revenue | (24,900) | ||
License revenues | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Revenue | $ 8 | $ 975 | |
Before Topic 606 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Revenue | $ 4,200 |
Fair value measurement - Change
Fair value measurement - Changes in Level 3 Liabilities and Contingent Consideration (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Aug. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 | |
Changes in Level 3 liabilities | |||||
Beginning Balance | $ 5,599 | $ 5,194 | $ 3,763 | ||
(Gains) / losses recognized in profit or loss | (1,181) | 1,900 | |||
Currency translation effects | (170) | 317 | (631) | ||
Ending Balance | 1,375 | 5,599 | 5,194 | ||
Issuance of financial instruments | (1,865) | ||||
Exercises of convertible loan warrants | (4,054) | ||||
Allocation to shareholder's equity | 2 | ||||
Contingent consideration | |||||
Percentage of future milestones that can be settled with ordinary shares | 100.00% | ||||
Percentage of future milestones that can be settled with ordinary shares, reduced rate | 50.00% | ||||
Increase in fair value of the contingent consideration | $ 2,300 | ||||
Number of shares issued | 64,648 | ||||
Fair value of derivative financial instruments | 5,599 | $ 5,194 | 3,763 | ||
Contingent consideration | |||||
Changes in Level 3 liabilities | |||||
Beginning Balance | 3,964 | 3,002 | 2,926 | ||
(Gains) / losses recognized in profit or loss | (1,181) | 1,838 | |||
Currency translation effects | (118) | 305 | |||
Ending Balance | 3,964 | 3,002 | |||
Issuance of financial instruments | (1,080) | ||||
Exercises of convertible loan warrants | (3,846) | ||||
Allocation to shareholder's equity | (8) | ||||
Contingent consideration | |||||
Fair value of derivative financial instruments | 3,964 | 3,002 | 2,926 | ||
Contingent consideration | InoCard | |||||
Changes in Level 3 liabilities | |||||
Beginning Balance | 4,000 | 1,800 | |||
Ending Balance | 0 | 4,000 | 1,800 | ||
Contingent consideration | |||||
Gain within research and development expenses | 3,800 | ||||
Fair value of derivative financial instruments | 4,000 | 1,800 | 1,800 | ||
Derivative financial instruments | |||||
Changes in Level 3 liabilities | |||||
Beginning Balance | 1,635 | 2,192 | 837 | ||
(Gains) / losses recognized in profit or loss | 62 | ||||
Currency translation effects | (52) | 12 | (631) | ||
Ending Balance | 1,375 | 1,635 | 2,192 | ||
Issuance of financial instruments | (785) | ||||
Exercises of convertible loan warrants | (208) | ||||
Allocation to shareholder's equity | 10 | ||||
Contingent consideration | |||||
Fair value of derivative financial instruments | $ 1,635 | $ 2,192 | $ 837 | ||
Restricted share units ("RSUs") | |||||
Contingent consideration | |||||
Percentage of future milestones that can be settled with ordinary shares, reduced rate | 50.00% | ||||
Upfront Payment Received | $ 1,200 |
Fair value measurement - BMS co
Fair value measurement - BMS collaboration (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Collaboration arrangements | ||
Derivative Asset | $ 1.4 | $ 1.6 |
BMS Warrants | ||
Collaboration arrangements | ||
Exercise price in respect of each warrant | $ 33.84 | |
Number of trading days used to calculate Volume Weighted Average Price ("VWAP") | 20 days | |
Number of days prior to purchase or exercise used to calculate Volume Weighted Average Price ("VWAP") | 5 days | |
Compounded annual growth rate used to determine fair value of exercise price | 10.00% | |
Increase in volatility rate | 10.00% | |
Volatility rate | 85.00% | |
BMS Warrants | Recurring | ||
Collaboration arrangements | ||
Derivative Asset | $ 0.8 | $ 1.3 |
Bristol Myers Squibb | uniQure N.V. | BMS Warrants | First Six New Targets Or Designation Of Sixth Target | ||
Collaboration arrangements | ||
Ownership percentage required per agreement | 14.90% | |
Bristol Myers Squibb | uniQure N.V. | BMS Warrants | First Nine New Targets Or Designation Of Ninth Target | ||
Collaboration arrangements | ||
Ownership percentage required per agreement | 19.90% |
Fair value measurement - Sensit
Fair value measurement - Sensitivity analysis on warrants (Details) - Level 3 - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
BMS Warrants | Other nonoperating income (expense) | |||
Fair value measurements | |||
Gain (Loss) recorded due to changes in fair value of derivative asset | $ 500 | $ 1,200 | $ 500 |
Recurring | Maximum | |||
Fair value measurements | |||
Expected exercise period | 4 years | ||
Recurring | Minimum | |||
Fair value measurements | |||
Expected exercise period | 2 years | ||
Recurring | BMS Warrants | |||
Fair value measurements | |||
Base case | $ 803 | ||
Increase volatility by 10% to 82.5% | 236 | ||
Extend exercise dates by one year | $ 55 |
Fair value measurement - Hercul
Fair value measurement - Hercules loan facility (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Fair value measurements | |||
(Gains) / losses recognized in profit or loss | $ (1,181) | $ 1,900 | |
Recurring | Level 3 | Hercules Loan Facility Warrant | |||
Fair value measurements | |||
Fair value of derivative liability | $ 600 | 300 | |
Recurring | Level 3 | Hercules Loan Facility Warrant | Other nonoperating income (expense) | |||
Fair value measurements | |||
(Gains) / losses recognized in profit or loss | $ (300) | $ (300) | $ 300 |
Collaboration arrangements an_3
Collaboration arrangements and concentration of credit risk - Revenues and amounts owed by collaboration partners (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Common Stock, Shares, Outstanding | 37,351,653 | 31,339,040 | |
Total | $ 11,284 | $ 13,107 | $ 25,098 |
Amounts owed in relation to the collaboration services | $ 233 | 1,586 | |
Bristol Myers Squibb | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Common Stock, Shares, Outstanding | 2,400,000 | ||
Amounts owed in relation to the collaboration services | $ 233 | $ 1,586 | |
Bristol Myers Squibb | Bristol Myers Squibb | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Minority interest | 6.40% | ||
Before Topic 606 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Total | $ 4,200 |
Collaboration arrangements an_4
Collaboration arrangements and concentration of credit risk - BMS collaboration - Narrative (Details) $ in Thousands | May 21, 2015USD ($) | Aug. 31, 2015USD ($) | Dec. 31, 2018USD ($)item | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Collaboration arrangements | |||||
Revenue | $ 11,284 | $ 13,107 | $ 25,098 | ||
Minimum | |||||
Collaboration arrangements | |||||
Decrease in revenue | 2,200 | ||||
Maximum | |||||
Collaboration arrangements | |||||
Decrease in revenue | 5,300 | ||||
License revenues from related party | |||||
Collaboration arrangements | |||||
Revenue | 7,528 | 4,121 | 3,940 | ||
Collaboration revenues from related party | |||||
Collaboration arrangements | |||||
Revenue | 3,756 | 4,340 | 13,019 | ||
Collaboration arrangement | Bristol Myers Squibb | |||||
Collaboration arrangements | |||||
Revenue | $ 11,284 | $ 8,461 | $ 16,959 | ||
License revenue | Bristol Myers Squibb | |||||
Collaboration arrangements | |||||
Number of potential targets included in collaborative agreement | item | 10 | ||||
Upfront payment recorded | $ 60,100 | ||||
Royalty term after the first commercial sale | 10 years | ||||
Average period for completion of pre-clinical phase | 4 years | ||||
Average period for completion of clinical development and commercial launch | 8 years 6 months | ||||
License revenue | Bristol Myers Squibb | First Target Selection | |||||
Collaboration arrangements | |||||
Milestone payments to be received upon achievement | $ 254,000 | ||||
License revenue | Bristol Myers Squibb | Second, Third, and Fourth Targets Selection | |||||
Collaboration arrangements | |||||
Target designation payment received | $ 15,000 | ||||
License revenue | Bristol Myers Squibb | Other Selected Targets | |||||
Collaboration arrangements | |||||
Maximum target designation payments to which entitled per agreement | 16,500 | ||||
Milestone payments to be received upon achievement | 217,000 | ||||
Before Topic 606 | |||||
Collaboration arrangements | |||||
Revenue | $ 4,200 |
Collaboration arrangements an_5
Collaboration arrangements and concentration of credit risk - Chiesi collaboration (Details) $ in Thousands, € in Millions | 1 Months Ended | 12 Months Ended | ||||
Jul. 31, 2017USD ($) | Jun. 30, 2013EUR (€) | Jun. 30, 2013USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Collaboration arrangements | ||||||
Revenue | $ 11,284 | $ 13,107 | $ 25,098 | |||
Percentage of costs to be paid by counterparty | 50.00% | |||||
Collaboration arrangement | Chiesi Pharmaceutical | ||||||
Collaboration arrangements | ||||||
Revenue | 4,646 | 8,139 | ||||
License revenue | Chiesi Pharmaceutical | ||||||
Collaboration arrangements | ||||||
Up-front payment received | € 17 | $ 22,100 | ||||
Revenue | $ 0 | $ 0 | $ 1,000 | |||
Deferred Revenue, Revenue Recognized | $ 13,800 | |||||
Glybera | License revenue | Chiesi Pharmaceutical | ||||||
Collaboration arrangements | ||||||
Reduction to license revenue that was previously amortized and repaid by the Company in accordance with the Termination Agreement | $ 500 |
Property, plant and equipment_3
Property, plant and equipment, net - Summary of PP&E (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property, plant and equipment, net | |||
Total property, plant, and equipment | $ 52,073 | $ 51,322 | |
Less accumulated depreciation | (22,894) | (17,041) | |
Property, plant and equipment, net | 29,179 | 34,281 | |
Depreciation | 6,500 | 7,000 | $ 5,500 |
Leasehold improvements | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | 32,462 | 32,297 | |
Laboratory equipment | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | 16,685 | 15,976 | |
Office equipment | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | 2,853 | 2,304 | |
Construction-in-progress | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | $ 73 | $ 745 |
Property, plant and equipment_4
Property, plant and equipment, net - PP&E by geographic region (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Long-lived assets | ||
Long-lived assets | $ 29,179 | $ 34,281 |
Lexington | ||
Long-lived assets | ||
Long-lived assets | 14,598 | 17,177 |
Amsterdam | ||
Long-lived assets | ||
Long-lived assets | $ 14,581 | $ 17,104 |
Intangible assets - Summary of
Intangible assets - Summary of acquired licenses (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Intangible assets | ||
Intangible assets, net | $ 5,201 | $ 9,570 |
Weighted average remaining life | 12 years 7 months 6 days | |
Capitalized expenditures related to milestone payments | $ 1,900 | |
Licenses | ||
Intangible assets | ||
Total intangible assets | 7,528 | 9,551 |
Less accumulated amortization | (2,327) | (5,575) |
Intangible assets, net | $ 5,201 | 3,976 |
Acquired research & development | ||
Intangible assets | ||
Intangible assets, net | $ 5,594 |
Intangible assets - Future amor
Intangible assets - Future amortization expense (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Estimated amortization expense for the next five years | ||
Intangible assets, net | $ 5,201 | $ 9,570 |
Licenses | ||
Estimated amortization expense for the next five years | ||
2,019 | 471 | |
2,020 | 471 | |
2,021 | 462 | |
2,022 | 433 | |
2,023 | 433 | |
Thereafter | 2,931 | |
Intangible assets, net | $ 5,201 | $ 3,976 |
Intangible assets - Carrying am
Intangible assets - Carrying amount of Licenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Intangible assets | |||
Carrying amount | $ 5,201 | $ 9,570 | |
Chiesi Pharmaceutical | |||
Intangible assets | |||
Amortization of Intangible Assets | 600 | ||
Licenses | |||
Intangible assets | |||
Carrying amount | 5,201 | 3,976 | |
Licenses | Research and development expenses | |||
Intangible assets | |||
Amortization of Intangible Assets | 400 | 1,000 | $ 300 |
Licenses | Protein Sciences Corporation | |||
Intangible assets | |||
Carrying amount | 2,084 | 2,340 | |
Licenses | St. Jude Children's Hospital | |||
Intangible assets | |||
Carrying amount | 633 | 707 | |
Licenses | Other | |||
Intangible assets | |||
Carrying amount | 2,484 | 929 | |
Acquired research & development | |||
Intangible assets | |||
Carrying amount | $ 5,594 | ||
Impairment loss recorded within R&D expense | $ 5,400 |
Accrued expenses and other (n_3
Accrued expenses and other (non) current liabilities - Breakdown of accrued expenses (Details) - USD ($) $ in Thousands | 1 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | |
Accrued expenses and other current liabilities | |||
Accruals for services provided by vendors-not yet billed | $ 1,999 | $ 2,348 | |
Personnel related accruals and liabilities | 5,688 | 5,646 | |
Other current liabilities | 545 | 844 | |
Total | $ 8,232 | $ 8,838 | |
Arbitration proceedings with Extera Partners LLC ("Extera") | Selling, general and administrative expense | |||
Accrued expenses and other current liabilities | |||
Arbitration settlement expenses | $ 2,900 |
Accrued expenses and other (n_4
Accrued expenses and other (non) current liabilities - Restructuring plan (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Restructuring Reserve | |
Beginning Balance | $ 625 |
Accrued through profit and loss | 96 |
Payments | (725) |
Currency translation effects | $ 4 |
Long-term debt (Details)
Long-term debt (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 06, 2018 | May 06, 2016 | |
Long-term Debt | |||||
Interest rate (as a percent) | 8.85% | 8.25% | |||
Discount rate (as a percent) | 5.50% | ||||
Back-end fee (as a percent) | 4.95% | ||||
Net cash inflow associated with increase in debt loan facility | $ 14,775,000 | ||||
Maximum borrowing capacity | 50,000,000 | $ 30,000,000 | |||
Amount drawn | 15,000,000 | ||||
Amount the company has right to draw | 15,000,000 | ||||
Back-end fees due | $ 35,000,000 | ||||
Facility fee (as a percent) | 0.50% | ||||
Foreign currency gain | $ 900,000 | $ 2,600,000 | $ 900,000 | ||
Interest expense recorded | 2,000,000 | 2,200,000 | 2,200,000 | ||
Aggregate maturities of loan | |||||
Coupon interest payments and financing fees | 13,200,000 | ||||
2,019 | 3,119,000 | ||||
2,020 | 4,119,000 | ||||
2,021 | 15,657,000 | ||||
2,022 | 15,657,000 | ||||
2,023 | 9,625,000 | ||||
Total | $ 48,177,000 | ||||
Venture debt loan facility with Hercules | |||||
Long-term Debt | |||||
Outstanding debt | 20,000,000 | $ 20,000,000 | $ 35,000,000 | ||
Discount rate (as a percent) | 5.25% | ||||
Back-end fee (as a percent) | 4.85% | ||||
Maximum borrowing capacity | $ 15,000,000 | ||||
Back-end fees due | 20,000,000 | ||||
Aggregate maturities of loan | |||||
Total | $ 35,700,000 | $ 20,800,000 |
Shareholders_ equity (Details)
Shareholders’ equity (Details) € / shares in Units, $ / shares in Units, $ in Thousands, € in Millions | May 07, 2018USD ($)$ / sharesshares | May 02, 2018shares | Oct. 27, 2017USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2017USD ($)€ / sharesshares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2018EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2016USD ($) |
Shareholders’ equity | ||||||||||
Authorized share capital | € 3 | $ 3,400 | ||||||||
Exchange rate (in USD per Euro) | 1.14449 | 1.14449 | ||||||||
Reserves for foreign currency translation effects | $ 3,800 | $ 3,800 | $ 3,800 | $ 7,300 | $ 6,600 | |||||
Shares issued in connection with offering | shares | 5,175,000 | 5,000,000 | ||||||||
Offering price per share of shares issued | $ / shares | $ 28.50 | $ 18.25 | ||||||||
Gross Proceeds From Issuance Initial Public Offering | $ 147,500 | |||||||||
Proceeds from issuance initial public offering | $ 138,361 | $ 85,290 | ||||||||
Net proceeds from issuance of common stock | $ 85,300 | |||||||||
Expenses capitalized related to offering | $ 200 | $ 500 | ||||||||
Shares authorized under offering program | shares | 5,000,000 | |||||||||
Restricted share units distributed during the period (in shares) | shares | 114,172 | 114,172 | ||||||||
Warrants converted | shares | 128,710 | 128,710 | ||||||||
Warrants exercise price | (per share) | $ 12 | $ 10.10 |
Share-based compensation - Summ
Share-based compensation - Summary of share-based compensation expense and unrecognized cost (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based compensation | |||
Share-based compensation expense | $ 10,693 | $ 10,280 | $ 6,214 |
Unrecognized compensation costs | $ 23,478 | ||
Weighted-average remaining period for recognition (in years) | 2 years 7 months 21 days | ||
Research and development expenses | Employees | |||
Share-based compensation | |||
Share-based compensation expense | $ 3,994 | 3,945 | 3,302 |
Research and development expenses | Non-employees | |||
Share-based compensation | |||
Share-based compensation expense | 670 | ||
Selling, general and administrative expense | Employees | |||
Share-based compensation | |||
Share-based compensation expense | 6,699 | 6,335 | 2,242 |
Share options | |||
Share-based compensation | |||
Share-based compensation expense | 4,766 | 3,246 | 5,187 |
Unrecognized compensation costs | $ 14,489 | ||
Weighted-average remaining period for recognition (in years) | 3 years 1 month 17 days | ||
Restricted share units ("RSUs") | |||
Share-based compensation | |||
Share-based compensation expense | $ 3,020 | 2,588 | 528 |
Unrecognized compensation costs | $ 4,055 | ||
Weighted-average remaining period for recognition (in years) | 2 years 1 month 13 days | ||
Performance share units ("PSUs") | |||
Share-based compensation | |||
Share-based compensation expense | $ 2,907 | $ 4,446 | $ 499 |
Unrecognized compensation costs | $ 4,934 | ||
Weighted-average remaining period for recognition (in years) | 1 year 7 months 13 days |
Share-based compensation - 2014
Share-based compensation - 2014 Plan option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 24, 2018 | Sep. 20, 2017 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Weighted-average assumptions used to estimate fair value of share options granted during year | |||||||
Expected volatility (as a percent) | 75.00% | ||||||
Expected terms (in years) | 10 years | 10 years | |||||
Risk free interest rate, minimum (as a percent) | 2.67% | 2.39% | 0.16% | ||||
Risk free interest rate, maximum (as a percent) | 3.20% | 2.81% | 2.67% | ||||
Expected dividend (as a percent) | 0.00% | 0.00% | 0.00% | ||||
Increase in authorized shares | 3,000,000 | 3,000,000 | 1,070,000 | ||||
Minimum | |||||||
Weighted-average assumptions used to estimate fair value of share options granted during year | |||||||
Expected volatility (as a percent) | 75.00% | 75.00% | |||||
Maximum | |||||||
Weighted-average assumptions used to estimate fair value of share options granted during year | |||||||
Expected volatility (as a percent) | 80.00% | 80.00% | |||||
Expected terms (in years) | 10 years | ||||||
Share options | |||||||
Weighted average remaining contractual life (in years) | |||||||
Exercised (in dollars) | $ 7,515 | $ 1,291 | $ 3,039 | ||||
Aggregate intrinsic value | |||||||
Exercised (in dollars) | 7,515 | $ 1,291 | $ 3,039 | ||||
Non-executive directors | Share options | |||||||
Options | |||||||
Granted (in shares) | 70,000 | 10,000 | |||||
Weighted average exercise price | |||||||
Vesting period (in years) | 4 years | 3 years | |||||
2012 Plan | |||||||
Share-based compensation | |||||||
Proceeds from options exercised | $ 300 | ||||||
Options | |||||||
Outstanding at beginning of year (in shares) | 72,818 | ||||||
Exercised (in shares) | (40,251) | ||||||
Outstanding at end of year (in shares) | 32,567 | 72,818 | |||||
Weighted average exercise price | |||||||
Outstanding at beginning of year (in dollars per share) | $ 5.77 | ||||||
Exercised (in dollars per share) | 6.21 | ||||||
Outstanding at end of year (in dollars per share) | $ 5.23 | $ 5.77 | |||||
Weighted average remaining contractual life (in years) | |||||||
Outstanding | 3 years 7 months 13 days | 3 years | |||||
Aggregate intrinsic value | |||||||
Outstanding (in dollars) | $ 939 | $ 922 | |||||
2012 Plan | Share options | |||||||
Options | |||||||
Exercised (in shares) | (40,251) | (405,188) | (510,547) | ||||
Weighted average remaining contractual life (in years) | |||||||
Exercised (in dollars) | $ 964 | $ 1,176 | $ 4,381 | ||||
Aggregate intrinsic value | |||||||
Exercised (in dollars) | 964 | $ 1,176 | $ 4,381 | ||||
2014 Plan | |||||||
Share-based compensation | |||||||
Proceeds from options exercised | $ 4,500 | ||||||
Options | |||||||
Outstanding at beginning of year (in shares) | 2,456,433 | ||||||
Granted (in shares) | 937,832 | ||||||
Forfeited (in shares) | (315,342) | ||||||
Expired (in shares) | (17,008) | ||||||
Exercised (in shares) | (388,203) | (198,552) | (239,861) | ||||
Outstanding at end of year (in shares) | 2,673,712 | 2,456,433 | |||||
Fully vested and exercisable at end of year (in shares) | 1,073,915 | ||||||
Outstanding and expected to vest at end of year (in shares) | 1,599,797 | 1,680,491 | |||||
Weighted average exercise price | |||||||
Outstanding at beginning of year (in dollars per share) | $ 10.06 | ||||||
Granted (in dollars per share) | 26.18 | ||||||
Forfeited (in dollars per share) | 13.27 | ||||||
Expired (in dollars per share) | 17.87 | ||||||
Exercised (in dollars per share) | 11.48 | ||||||
Outstanding at end of year (in dollars per share) | 15.09 | $ 10.06 | |||||
Fully vested and exercisable at end of year (in dollars per share) | 10.80 | ||||||
Outstanding and expected to vest at end of year (in dollars per share) | $ 17.96 | $ 8.62 | |||||
Total weighted average grant date fair value of options issued during the period (in $ millions) | $ 14,900 | ||||||
Vesting period (in years) | 4 years | ||||||
Weighted-average assumptions used to estimate fair value of share options granted during year | |||||||
Authorized shares | 8,601,471 | ||||||
Weighted average remaining contractual life (in years) | |||||||
Outstanding | 7 years 11 months 23 days | 7 years 11 months 1 day | |||||
Fully vested and exercisable at end of year | 6 years 10 months 24 days | ||||||
Outstanding and expected to vest at end of year | 8 years 8 months 12 days | ||||||
Aggregate intrinsic value | |||||||
Outstanding (in dollars) | $ 39,616 | $ 24,213 | |||||
Fully vested and exercisable | 19,348 | ||||||
Outstanding and expected to vest | $ 20,268 | ||||||
2014 Plan | Share options | |||||||
Options | |||||||
Granted (in shares) | 150,000 | 937,832 | 1,295,350 | 1,024,178 | |||
Forfeited (in shares) | (315,342) | ||||||
Outstanding and expected to vest at end of year (in shares) | 1,599,797 | 1,680,491 | |||||
Weighted average exercise price | |||||||
Granted (in dollars per share) | $ 8.49 | ||||||
Outstanding and expected to vest at end of year (in dollars per share) | $ 10.83 | $ 5.06 | |||||
Weighted average grant-date fair value | |||||||
Vested (in shares) | 689,892 | ||||||
Vested (in dollar per share) | $ 5.08 | ||||||
Forfeited (in dollar per share) | $ 7.96 | ||||||
2014 Plan | Non-executive directors | |||||||
Weighted average exercise price | |||||||
Vesting period (in years) | 1 year | ||||||
2014 Plan | Directors and Officers | |||||||
Options | |||||||
Granted (in shares) | 315,156 | ||||||
Weighted average exercise price | |||||||
Granted (in dollars per share) | $ 4.7 | ||||||
2014 Plan | One year from grant date | |||||||
Weighted average exercise price | |||||||
Vesting percentage per year | 25.00% | ||||||
Vesting period (in years) | 1 year |
Share-based compensation - 20_2
Share-based compensation - 2014 Plan RSU activity (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 24, 2018 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Weighted average grant-date fair value | |||||
Granted (in dollars per share) | $ 9.05 | ||||
Other disclosure | |||||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 1,730 | ||||
2014 Plan | |||||
Other disclosure | |||||
Vesting period (in years) | 4 years | ||||
2014 Plan | Non-executive directors | |||||
Other disclosure | |||||
Vesting period (in years) | 1 year | ||||
Restricted share units ("RSUs") | |||||
Number of shares | |||||
Non-vested at beginning of year (in shares) | 683,663 | ||||
Restricted stock granted (in shares) | 262,599 | ||||
Vested (in shares) | (341,833) | ||||
Forfeited (in shares) | (192,108) | ||||
Non-vested at end of year (in shares) | 412,321 | 683,663 | |||
Weighted average grant-date fair value | |||||
Non-vested at beginning of year (in dollars per share) | $ 6.38 | ||||
Granted (in dollars per share) | 23.61 | ||||
Vested (in dollars per share) | 6.43 | ||||
Forfeited (in dollars per share) | 8.15 | ||||
Non-vested at end of year (in dollars per share) | $ 16.49 | $ 6.38 | |||
Other disclosure | |||||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 6,200 | ||||
Restricted share units ("RSUs") | Directors and Officers | |||||
Number of shares | |||||
Restricted stock granted (in shares) | 133,808 | ||||
Weighted average grant-date fair value | |||||
Granted (in dollars per share) | $ 3.3 | ||||
Restricted share units ("RSUs") | 2014 Plan | |||||
Number of shares | |||||
Restricted stock granted (in shares) | 262,599 | 603,350 | 358,678 | ||
Weighted average grant-date fair value | |||||
Granted (in dollars per share) | $ 23.61 | $ 5.86 | |||
Other disclosure | |||||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 8,546 | $ 2,917 | $ 2,296 | ||
Share options | Non-executive directors | |||||
Other disclosure | |||||
Vesting period (in years) | 4 years | 3 years | |||
Share options | 2014 Plan | |||||
Weighted average grant-date fair value | |||||
Granted (in dollars per share) | $ 15.90 | $ 3.87 | $ 6.67 |
Share-based compensation - 20_3
Share-based compensation - 2014 Plan PSU activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Weighted average grant-date fair value | |||
Granted (in dollars per share) | $ 9.05 | ||
Other disclosure | |||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 1,730 | ||
Performance share units ("PSUs") | |||
Number of shares | |||
Non-vested at beginning of year (in shares) | 511,074 | ||
Vested (in shares) | (68,115) | ||
Forfeited (in shares) | (65,790) | ||
Non-vested at end of year (in shares) | 377,169 | 511,074 | |
PSUs awarded but not yet earned | 136,982 | ||
Total non-vested and discretionary PSUs | 514,151 | ||
Weighted average grant-date fair value | |||
Non-vested at beginning of year (in dollars per share) | $ 16.73 | ||
Vested (in dollars per share) | 15.79 | ||
Forfeited (in dollars per share) | 17.44 | ||
Non-vested at end of year (in dollars per share) | 16.73 | $ 16.73 | |
PSUs awarded but not yet earned (in dollars per share) | 28.82 | ||
Total non-vested and discretionary PSUs (in dollars per share) | $ 19.95 | ||
Other disclosure | |||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 3,900 | ||
Performance share units ("PSUs") | 2014 Plan | |||
Number of shares | |||
Restricted stock granted (in shares) | 550,570 | 111,564 | |
Weighted average grant-date fair value | |||
Granted (in dollars per share) | $ 17.15 | $ 5.76 | |
Other disclosure | |||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 1,350 | ||
Share options | 2014 Plan | |||
Weighted average grant-date fair value | |||
Granted (in dollars per share) | $ 15.90 | $ 3.87 | $ 6.67 |
Share-based compensation - Empl
Share-based compensation - Employee Share Purchase Plan (Details) - shares | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based compensation | |||
Number of shares issued | 64,648 | ||
Employee Stock [Member] | |||
Share-based compensation | |||
Ordinary shares available for issue | 150,000 | ||
Discounted rate for purchase of shares | 85.00% | ||
Number of shares issued | 2,591 |
Share-based compensation - 2012
Share-based compensation - 2012 Plan option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share options | |||
Weighted average remaining contractual life (in years) | |||
Exercised (in dollars) | $ 7,515 | $ 1,291 | $ 3,039 |
Aggregate intrinsic value | |||
Exercised (in dollars) | 7,515 | $ 1,291 | $ 3,039 |
2012 Plan | |||
Share-based compensation | |||
Proceeds from options exercised | $ 300 | ||
Options | |||
Outstanding at beginning of year (in shares) | 72,818 | ||
Exercised (in shares) | (40,251) | ||
Outstanding at end of year (in shares) | 32,567 | 72,818 | |
Weighted average exercise price | |||
Outstanding at beginning of year (in dollars per share) | $ 5.77 | ||
Exercised (in dollars per share) | 6.21 | ||
Outstanding at end of year (in dollars per share) | $ 5.23 | $ 5.77 | |
Weighted average remaining contractual life (in years) | |||
Outstanding | 3 years 7 months 13 days | 3 years | |
Aggregate intrinsic value | |||
Outstanding (in dollars) | $ 939 | $ 922 | |
2012 Plan | Share options | |||
Options | |||
Exercised (in shares) | (40,251) | (405,188) | (510,547) |
Weighted average remaining contractual life (in years) | |||
Exercised (in dollars) | $ 964 | $ 1,176 | $ 4,381 |
Aggregate intrinsic value | |||
Exercised (in dollars) | $ 964 | $ 1,176 | $ 4,381 |
Expenses by nature - Operating
Expenses by nature - Operating expenses excluding expenses presented in other expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating expenses: | |||
Employee-related expenses | $ 46,254 | $ 46,373 | $ 42,260 |
Laboratory and development expenses | 23,596 | 17,737 | 21,054 |
Office and housing expenses | 7,281 | 9,327 | 10,384 |
Legal and advisory expenses | 7,748 | 8,121 | 11,715 |
Depreciation, amortization and impairment expenses | 12,415 | 6,779 | 6,089 |
Patent and license expenses | 1,202 | 817 | 1,348 |
Non-employee share-based compensation expenses | 670 | ||
Other operating expenses | 1,618 | 7,653 | 4,989 |
Total | $ 100,114 | $ 96,807 | $ 98,509 |
Expenses by nature - Employee-r
Expenses by nature - Employee-related expenses (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018USD ($)employee | Dec. 31, 2017USD ($)employee | Dec. 31, 2016USD ($)employee | |
Employee-related expenses | |||
Wages and salaries | $ 26,646 | $ 25,131 | $ 24,999 |
Share-based compensation expenses | 10,708 | 10,280 | 5,544 |
Consultant expenses | 2,974 | 4,758 | 5,873 |
Social security costs | 2,231 | 2,077 | 1,824 |
Health insurance | 1,750 | 1,536 | 1,099 |
Pension costs - defined contribution plans | 628 | 802 | 1,088 |
Other employee expenses | 1,317 | 1,789 | 1,833 |
Total | $ 46,254 | $ 46,373 | $ 42,260 |
Number of employees at the end of the period | employee | 212 | 202 | 251 |
Other non-operating income _ _3
Other non-operating income / (expense) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Other non-operating income | |||
Derivative gains | $ 208 | $ 785 | |
Total other non-operating income: | 208 | 785 | |
Other non-operating expense | |||
Derivative losses | $ (2,192) | ||
Finance expenses | (243) | ||
Total other non-operating expense: | (2,435) | ||
Other non-operating (expense) / income, net | 208 | (2,435) | 785 |
Gain (Loss) recorded due to changes in fair value of derivative liability | (1,181) | 1,900 | |
Recurring | Level 3 | Hercules Loan Facility Warrant | Other nonoperating income (expense) | |||
Other non-operating expense | |||
Gain (Loss) recorded due to changes in fair value of derivative liability | (300) | (300) | 300 |
Bristol Myers Squibb | |||
Other non-operating income | |||
Derivative gains | $ 500 | $ 500 | |
Other non-operating expense | |||
Derivative losses | $ (1,200) |
Income taxes - Loss before inco
Income taxes - Loss before income taxes and income tax benefit / (expense) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Loss before income taxes | |||
Dutch operations | $ (85,721) | $ (60,966) | $ (51,107) |
Loss before income tax expense | (83,073) | (79,459) | (72,229) |
Deferred benefit / (expense) | |||
Dutch operations | (209) | 209 | (1,094) |
Income tax benefit / (expense) | (231) | 199 | (1,145) |
U.S. operations | |||
Loss before income taxes | |||
Loss before income tax benefit / (expense) | 2,646 | (18,493) | (21,221) |
Foreign operations | |||
Loss before income taxes | |||
Loss before income tax benefit / (expense) | 3 | 99 | |
Current benefit / (expense) | |||
Current benefit / (expense) | $ (22) | $ (10) | $ (51) |
Income taxes - Tax rate reconci
Income taxes - Tax rate reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Tax rate reconciliation | |||
Net loss before tax for the period | $ (83,073) | $ (79,459) | $ (72,229) |
Expected tax benefit / (expense) at the tax rate enacted in the Netherlands (25%) | 20,768 | 19,865 | 18,057 |
Difference in tax rates between the Netherlands and foreign countries | (106) | 1,664 | 1,905 |
Net change in valuation allowance | (19,207) | (17,358) | (20,054) |
Non deductible expenses | (2,648) | (3,248) | (1,323) |
Change in fair value of contingent consideration | 962 | (724) | 270 |
Income tax benefit / (expense) | $ (231) | 199 | (1,145) |
Tax rate enacted in the Netherlands | 25.00% | ||
Non-deductible expenses, Share-based compensation | $ 2,700 | 2,500 | 1,600 |
Non-deductible expenses, Derivatives | $ 0 | $ 500 | $ 0 |
Income taxes - Significant comp
Income taxes - Significant components of deferred taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||||
Deferred tax asset attributable to carryforward losses | $ 74,529 | $ 73,207 | ||
Intangible assets | 847 | 924 | ||
Property, plant and equipment | 561 | 173 | ||
Deferred revenue | 7,481 | 17,930 | ||
Accrued expenses and other current liabilities | 1,682 | 1,657 | ||
Gross deferred tax asset | 85,100 | 93,891 | ||
Less valuation allowance | (85,100) | (93,682) | $ (82,642) | $ (65,593) |
Net deferred tax asset | 209 | |||
Deferred tax liabilities: | ||||
Long-term loan to foreign operation | (209) | |||
Net deferred tax liability | (209) | |||
Total net deferred income tax liabilities |
Income taxes - Changes in valua
Income taxes - Changes in valuation allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Opening balance | $ 93,682 | $ 82,642 | $ 65,593 |
Changes related to reduction of deferred revenue recorded in equity upon implementation of ASC 606 Revenue recognition as of January 1, 2018 | (6,229) | ||
Changes recorded in profit and loss | 19,207 | 19,080 | 20,054 |
Reduction related to tax reform | (15,670) | ||
Changes recorded in profit and loss related to US tax reform | (15,670) | ||
Currency translation effects | (5,890) | (6,318) | (3,005) |
Ending balance | $ 85,100 | 93,682 | $ 82,642 |
U.S. operations | |||
Reduction related to tax reform | (1,722) | ||
Changes recorded in profit and loss related to US tax reform | $ (1,722) |
Income taxes - Effective Tax Ra
Income taxes - Effective Tax Rate (Details) - USD ($) $ in Millions | Jan. 01, 2021 | Jan. 01, 2019 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2017 |
U.S. corporate statutory income tax rate (as a percent) | 25.00% | ||||
Reduction of gross deferred tax asset | $ (15.6) | $ (1.7) | |||
Operating loss carryforwards period (in years) | 9 years | ||||
Utilization of tax losses, percent of taxable income | 80.00% | ||||
Forecast | |||||
U.S. corporate statutory income tax rate (as a percent) | 20.50% | 22.55% | |||
Operating loss carryforwards period (in years) | 6 years | ||||
U.S. operations | |||||
U.S. corporate statutory income tax rate (as a percent) | 21.00% | ||||
U.S. operations | Maximum | |||||
U.S. corporate statutory income tax rate (as a percent) | 35.00% |
Income taxes - Tax losses expir
Income taxes - Tax losses expiring (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Tax loss carry-forwards | |||
Tax loss carry-forward expiration (in years) | 9 years | ||
Tax loss carry-forwards | $ 311,700 | $ 246,000 | $ 182,000 |
Unrecognized Tax Benefits | 0 | 0 | $ 0 |
2,017 | |||
Tax loss carry-forwards | |||
Loss expiring | 20,000 | $ 24,500 | |
2,019 | |||
Tax loss carry-forwards | |||
Loss expiring | 20,746 | ||
2,020 | |||
Tax loss carry-forwards | |||
Loss expiring | 18,857 | ||
2,021 | |||
Tax loss carry-forwards | |||
Loss expiring | 14,189 | ||
2,022 | |||
Tax loss carry-forwards | |||
Loss expiring | 24,148 | ||
2,023 | |||
Tax loss carry-forwards | |||
Loss expiring | 23,518 | ||
U.S. operations | 2017 | |||
Tax loss carry-forwards | |||
Loss expiring | 55,100 | ||
U.S. operations | 2018 | |||
Tax loss carry-forwards | |||
Tax loss carry-forwards | $ 50,600 |
Basic and diluted earnings pe_3
Basic and diluted earnings per share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Basic and diluted earnings per share | |||
Total potential dilutive common shares | 12,108,956 | 10,561,163 | 6,526,407 |
Warrants | |||
Basic and diluted earnings per share | |||
Total potential dilutive common shares | 37,175 | 37,175 | 37,175 |
Warrants | Bristol Myers Squibb | |||
Basic and diluted earnings per share | |||
Total potential dilutive common shares | 8,575,000 | 6,800,000 | 3,587,333 |
Stock options | 2014 Plan | |||
Basic and diluted earnings per share | |||
Total potential dilutive common shares | 2,673,712 | 2,456,433 | 2,000,266 |
Stock options | 2012 Plan | |||
Basic and diluted earnings per share | |||
Total potential dilutive common shares | 32,567 | 72,818 | 483,006 |
Stock options | Employee Share Purchase Plan | |||
Basic and diluted earnings per share | |||
Total potential dilutive common shares | 1,012 | ||
Non-vested and earned RSUs and PSUs | |||
Basic and diluted earnings per share | |||
Total potential dilutive common shares | 789,490 | 1,194,737 | 418,627 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Millions | Nov. 30, 2013item | May 31, 2017facility | Dec. 31, 2018USD ($)ft² | Nov. 30, 2018 | Dec. 01, 2017 | Jun. 30, 2016 | Mar. 31, 2016 |
Leases | |||||||
Lease incentives | $ 12.2 | ||||||
Lexington | |||||||
Leases | |||||||
Lease term (in years) | 10 years | 5 years | |||||
Area of facility (in square feet) | ft² | 30,655 | ||||||
Number of subsequent renewals | item | 2 | ||||||
Renewal term (in years) | 5 years | ||||||
Amsterdam | |||||||
Leases | |||||||
Lease term (in years) | 10 years | 16 years | |||||
Renewal term (in years) | 5 years | ||||||
Number of facility sites consolidated into new site | facility | 3 | ||||||
Minimum rentals to be received | $ 9.5 |
Leases - Minimum Lease Payments
Leases - Minimum Lease Payments and Rent Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Minimum lease payments | |||
2,019 | $ 4,670 | ||
2,020 | 5,330 | ||
2,021 | 5,425 | ||
2,022 | 5,522 | ||
2,023 | 5,620 | ||
Thereafter | 40,977 | ||
Total minimum lease payments | 67,544 | ||
Deferred rent related to lease incentives-non current | 8,761 | ||
Deferred rent related to lease incentives-current | 311 | ||
Aggregate rent expense | |||
Rent expense | 3,250 | $ 3,606 | $ 3,974 |
Lexington | |||
Minimum lease payments | |||
2,019 | 2,707 | ||
2,020 | 3,360 | ||
2,021 | 3,455 | ||
2,022 | 3,552 | ||
2,023 | 3,650 | ||
Thereafter | 24,892 | ||
Total minimum lease payments | 41,616 | ||
Deferred rent related to lease incentives-non current | 4,974 | ||
Aggregate rent expense | |||
Rent expense | 1,583 | 1,103 | 1,103 |
Amsterdam | |||
Minimum lease payments | |||
2,019 | 1,963 | ||
2,020 | 1,970 | ||
2,021 | 1,970 | ||
2,022 | 1,970 | ||
2,023 | 1,970 | ||
Thereafter | 16,085 | ||
Total minimum lease payments | 25,926 | ||
Deferred rent related to lease incentives-non current | 3,787 | ||
Deferred rent related to lease incentives-current | 311 | ||
Aggregate rent expense | |||
Rent expense | $ 1,667 | $ 2,503 | $ 2,871 |
Related party transaction (Deta
Related party transaction (Details) | Oct. 24, 2018USD ($)shares | Sep. 20, 2017$ / sharesshares | Aug. 07, 2017EUR (€) | Jun. 30, 2018shares | Dec. 31, 2018$ / sharesshares | Dec. 31, 2017shares | Dec. 31, 2016shares |
Related Party Transaction [Line Items] | |||||||
Base salary | € | € 200,000 | ||||||
Holiday allowance, as a percent | 8.00% | ||||||
Maximum bonus, as a percent | 40.00% | ||||||
Non-executive directors | |||||||
Related Party Transaction [Line Items] | |||||||
Base salary | $ | $ 425,000 | ||||||
Maximum bonus, as a percent | 40.00% | ||||||
2014 Plan | |||||||
Related Party Transaction [Line Items] | |||||||
Granted (in shares) | 937,832 | ||||||
Vesting period (in years) | 4 years | ||||||
Granted (in dollars per share) | $ / shares | $ 26.18 | ||||||
2014 Plan | Non-executive directors | |||||||
Related Party Transaction [Line Items] | |||||||
Vesting period (in years) | 1 year | ||||||
Share options | Non-executive directors | |||||||
Related Party Transaction [Line Items] | |||||||
Granted (in shares) | 70,000 | 10,000 | |||||
Vesting period (in years) | 4 years | 3 years | |||||
Share options | 2014 Plan | |||||||
Related Party Transaction [Line Items] | |||||||
Granted (in shares) | 150,000 | 937,832 | 1,295,350 | 1,024,178 | |||
Granted (in dollars per share) | $ / shares | $ 8.49 | ||||||
Restricted Stock Units | Non-executive directors | |||||||
Related Party Transaction [Line Items] | |||||||
Restricted stock granted (in shares) | 35,000 | ||||||
Vesting period (in years) | 3 years |
Uncategorized Items - qure-2018
Label | Element | Value |
Proceeds from Issuance of Common Stock | us-gaap_ProceedsFromIssuanceOfCommonStock | $ 91,300,000 |