Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 26, 2020 | Jun. 30, 2019 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Transition Report | false | ||
Entity File Number | 001-36294 | ||
Entity Registrant Name | uniQure N.V. | ||
Entity Incorporation, State or Country Code | P7 | ||
Entity Address, Address Line One | Paasheuvelweg 25a | ||
Entity Address, City or Town | 1105 BP Amsterdam | ||
Entity Address, Country | NL | ||
City Area Code | 31 | ||
Local Phone Number | 20-240-6000 | ||
Title of 12(b) Security | Ordinary shares, par value €0.05 per share | ||
Trading Symbol | QURE | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 2,957.2 | ||
Entity Common Stock, Shares Outstanding | 44,254,903 | ||
Entity Central Index Key | 0001590560 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 377,793 | $ 234,898 |
Accounts receivable and accrued income from related party | 947 | 233 |
Prepaid expenses | 4,718 | 1,116 |
Other current assets | 748 | 329 |
Total current assets | 384,206 | 236,576 |
Non-current assets | ||
Property, plant and equipment, net | 28,771 | 29,179 |
Operating lease right-of-use assets | 26,797 | |
Intangible assets, net | 5,427 | 5,201 |
Goodwill | 496 | 506 |
Restricted cash | 2,933 | 2,444 |
Total non-current assets | 64,424 | 37,330 |
Total assets | 448,630 | 273,906 |
Current liabilities | ||
Accounts payable | 5,681 | 3,792 |
Accrued expenses and other current liabilities | 12,457 | 8,232 |
Current portion of operating lease liabilities | 5,865 | |
Current portion of deferred rent (see note 2.3.23) | 311 | |
Current portion of deferred revenue | 7,627 | 7,634 |
Total current liabilities | 31,630 | 19,969 |
Non-current liabilities | ||
Long-term debt | 36,062 | 35,471 |
Operating lease liabilities, net of current portion | 31,133 | |
Deferred rent, net of current portion (see note 2.3.23) | 8,761 | |
Deferred revenue, net of current portion | 23,138 | 28,861 |
Derivative financial instruments related party | 3,075 | 803 |
Other non-current liabilities | 534 | 435 |
Total non-current liabilities | 93,942 | 74,331 |
Total liabilities | 125,572 | 94,300 |
Commitments and contingencies | ||
Shareholders' equity | ||
Ordinary shares, 0.05 par value: 60,000,000 shares authorized at December 31, 2019 and December 31, 2018 and 43,711,954 and 37,351,653 ordinary shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively. | 2,651 | 2,299 |
Additional paid-in-capital | 986,803 | 720,072 |
Accumulated other comprehensive loss | (6,689) | (7,259) |
Accumulated deficit | (659,707) | (535,506) |
Total shareholders' equity | 323,058 | 179,606 |
Total liabilities and shareholders' equity | $ 448,630 | $ 273,906 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - € / shares | Dec. 31, 2019 | Dec. 31, 2018 |
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 | 43,711,954 | 37,351,653 |
Ordinary shares, outstanding | 43,711,954 | 37,351,653 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Total revenues | $ 7,281 | $ 11,284 | $ 13,107 |
Operating expenses: | |||
Research and development expenses | (94,737) | (74,809) | (72,172) |
Selling, general and administrative expenses | (33,544) | (25,305) | (24,635) |
Total operating expenses | (128,281) | (100,114) | (96,807) |
Other income | 1,888 | 2,146 | 15,430 |
Other expense | (2,028) | (1,548) | (3,073) |
Loss from operations | (121,140) | (88,232) | (71,343) |
Interest income | 3,547 | 2,729 | 117 |
Interest expense | (3,810) | (2,160) | (2,232) |
Foreign currency (losses) / gains, net | (268) | 4,382 | (3,566) |
Other non-operating (losses) / gains, net | (2,530) | 208 | (2,435) |
Loss before income tax expense | (124,201) | (83,073) | (79,459) |
Income tax (expense) / benefit | (231) | 199 | |
Net loss | (124,201) | (83,304) | (79,260) |
Other comprehensive income (loss), net of income tax: | |||
Foreign currency translation adjustments net of tax impact of nil for the year ended December 31, 2019 (2018: $(0.2) million and 2017: $0.2 million) | 570 | (5,261) | 2,757 |
Total comprehensive loss | $ (123,631) | $ (88,565) | $ (76,503) |
Basic and diluted net loss per ordinary share | $ (3,110) | $ (2,340) | $ (2,940) |
Weighted average shares used in computing basic and diluted net loss per ordinary share | 39,999,450 | 35,639,745 | 26,984,183 |
License revenues | |||
Total revenues | $ 8 | ||
License revenues from related party | |||
Total revenues | $ 4,988 | $ 7,528 | 4,121 |
Collaboration revenues | |||
Total revenues | 4,638 | ||
Collaboration revenues from related party | |||
Total revenues | $ 2,293 | $ 3,756 | $ 4,340 |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||
Foreign currency translation adjustments, tax | $ 0 | $ (0.2) | $ 0.2 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Ordinary shares | Additional paid-in capital | Accumulated other comprehensive (loss)/income | Accumulated deficit | Total |
Beginning balance at Dec. 31, 2016 | $ 1,593 | $ 464,653 | $ (6,557) | $ (396,058) | $ 63,631 |
Beginning 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 | ||||
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 | |||
Increase (decrease) in shareholders' equity | |||||
Loss for the period | (124,201) | $ (124,201) | |||
Other comprehensive income (loss) | 570 | 570 | |||
Follow-on public offering | $ 311 | 242,363 | 242,674 | ||
Follow-on public offering (in shares) | 5,625,000 | ||||
Hercules warrants exercise | $ 2 | 1,271 | 1,273 | ||
Hercules warrants exercise (in shares) | 37,175 | ||||
Exercise of share options | $ 25 | 5,210 | 5,235 | ||
Exercise of share options (in shares) | 453,232 | ||||
Restricted and performance share units distributed during the period | $ 14 | (14) | |||
Restricted and performance share units distributed during the period (in shares) | 235,692 | ||||
Share-based compensation expense | 17,533 | 17,533 | |||
Issuance of ordinary shares relating to employee stock purchase plan | 368 | 368 | |||
Issuance of ordinary shares relating to employee stock purchase plan (in shares) | 9,202 | ||||
Ending balance at Dec. 31, 2019 | $ 2,651 | $ 986,803 | $ (6,689) | $ (659,707) | $ 323,058 |
Ending balance (in shares) at Dec. 31, 2019 | 43,711,954 | 43,711,954 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities | |||
Net loss | $ (124,201) | $ (83,304) | $ (79,260) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation, amortization and impairment losses | 6,669 | 12,415 | 7,543 |
Share-based compensation expense | 17,533 | 10,708 | 10,280 |
Change in fair value of derivative financial instruments and contingent consideration | 2,530 | (4,054) | 5,194 |
Unrealized foreign exchange losses / (gains) | 891 | (5,502) | 4,222 |
Change in deferred tax expense | 231 | 209 | |
Change in lease incentives | (330) | 2,215 | |
Changes in operating assets and liabilities: | |||
Accounts receivable and accrued income, prepaid expenses and other current assets | (4,769) | 1,578 | 9,715 |
Accounts payable | 1,652 | 1,065 | (1,670) |
Accrued expenses, other liabilities and operating leases | 6,010 | (382) | (1,640) |
Deferred revenue | (4,999) | (8,462) | (21,078) |
Net cash used in operating activities | (98,684) | (76,037) | (64,270) |
Cash flows from investing activities | |||
Purchases of intangible assets | (996) | (1,861) | (1,122) |
Purchases of property, plant and equipment | (5,651) | (2,384) | (4,461) |
Net cash used in investing activities | (6,647) | (4,245) | (5,583) |
Cash flows from financing activities | |||
Proceeds from issuance of shares related to employee stock option and purchase plans | 5,603 | 4,825 | 4,044 |
Proceeds from exercises of convertible loan warrants | 1,322 | ||
Proceeds from public offering of shares, net of issuance costs | 242,718 | 138,361 | 85,290 |
Proceeds from loan increment | 14,775 | ||
Contingent consideration payment | (582) | ||
Proceeds from exercise of warrants | 500 | ||
Net cash generated from financing activities | 248,821 | 157,961 | 90,074 |
Currency effect cash, cash equivalents and restricted cash | (106) | (2,187) | 7,306 |
Net increase in cash, cash equivalents and restricted cash | 143,384 | 75,491 | 27,527 |
Cash, cash equivalents and restricted cash at beginning of period | 237,342 | 161,851 | 134,324 |
Cash, cash equivalents and restricted cash at the end of period | 380,726 | 237,342 | 161,851 |
Total cash, cash equivalents and restricted cash | 380,726 | 237,342 | 134,324 |
Supplemental cash flow disclosures: | |||
Cash paid for interest | 2,141 | 1,624 | |
Cash paid for interest | (3,117) | ||
Non-cash increases (decreases) in accounts payables related to purchases of intangible assets and property, plant and equipment | $ 313 | $ (48) | $ (1,557) |
General business information
General business information | 12 Months Ended |
Dec. 31, 2019 | |
General business information | |
General business information | 1. General business information 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, 2019 | |
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, 2019 and the Company’s budgeted cash flows for the twelve months following the issuance date. 2.2 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 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 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 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, if any. 2.3.3 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. 2.3.4 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 ● 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 4, “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 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 4, “Fair value measurement,” for additional information. 2.3.6 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 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 The Company follows the provisions of ASC 260, Earnings Per Share 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 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. Right-of-use assets are also reviewed for impairment in accordance with ASC 360. 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 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 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 Deposits 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 receivables are amounts due from services provided to the Company’s collaboration partner and are purely trade receivables. 2.3.14 Prepaid expenses are amounts paid in the period, for which the benefit has not been realized, and include payments made for insurance and research and clinical contracts. The related expense will be recognized in the subsequent period as incurred. 2.3.15 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 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 The Company accounts for its share-based compensation awards in accordance with ASC 718, Compensation-Stock Compensation. 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. The requirements of ASC 718 are also applied to nonemployee share-based payment transactions except for specific guidance on certain inputs to an option-pricing model and the attribution of cost. 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 3 “Collaboration arrangements and concentration of credit risk” for additional information. Revenue recognition for the year ended December 31, 2017: During the year ended December 31, 2017 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 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 in 2017 is presented as other income in 2017 with no such income in 2018 and 2019. 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 with no such expenses in 2018 and 2019. 2.3.21 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 are recorded in accordance with ASC 740, Income Taxes 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. Recognized tax positions are measured at the largest amount of tax benefit that is greater than 50 percent likely of being realized upon settlement. 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, 2019, and 2018, the Company did not have any significant unrecognized tax benefits. 2.3.23 Recently Adopted Accounting Pronouncements ASC 842 - Leases (Topic 842) 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) – Target Improvements” (ASU 2018-11), which address implementation issues related to the new lease standard. The standard is effective for interim and annual reporting periods beginning after December 15, 2018. Under the new standard, lessees are required to recognize the right-of-use assets and lease liabilities that arise from operating leases on the Consolidated balance sheet. The Company adopted the standard using the modified retrospective approach with an effective date as of the beginning of the Company’s fiscal year, January 1, 2019, to operating leases that existed on that date. Prior year comparative financial information was not recast under the new standard and continues to be presented under ASC 840. The Company elected to utilize the package of practical expedients available for expired or existing contracts which allowed the Company to carryforward historical assessments of (1) whether contracts are or contain leases, (2) lease classification, and (3) initial direct costs. The Company performed an assessment and identified the lease facilities as leases to be accounted for under ASC 842 as of January 1, 2019. The Company elected to implement ASC 842 by applying the modified retrospective approach, which allows the Company to restrict the application of the new guidance to operating leases as of January 1, 2019. The impact of implementing ASC 842 is summarized below: - Recognized a $19.0 million operating right-of-use asset and a $28.1 million operating lease liability in relation to the facilities leased at the Amsterdam and Lexington sites in the Consolidated balance sheet as of January 1, 2019; - Presented deferred rent of $9.1 million as of December 31, 2018, as a reduction of the right-of-use asset as from January 1, 2019 onwards in the Consolidated balance sheet and as a change within operating cash flows within accrued expense, other liabilities and operating leases; The Company measured the lease liability at the present value of the future lease payments as of January 1, 2019. The Company used an incremental borrowing rate to discount the lease payments. The Company derived the discount rate, adjusted for differences such as in the term and payment patterns, from the Company’s loan from Hercules Capital, which was refinanced immediately prior to the January 1, 2019 adoption date in December 2018. The right-of-use asset is valued at the amount of the lease liability reduced by the remaining December 31, 2018 balance of lease incentives received. The lease liability is subsequently measured at the present value of the future lease payments as of the reporting date with a corresponding adjustment to the right-to-use asset. Absent a lease modification, the Company will continue to utilize the January 1, 2019, incremental borrowing rate. The Company will continue to recognize lease cost on a straight-line basis and will continue to present these costs as operating expenses within the Consolidated statements of operations and comprehensive loss. The Company will continue to present lease payments and landlord incentive payments within cash flows from operations within the Consolidated statements of cash flows. The financial results for year ended December 31, 2019, is presented under the new standard, while the comparative periods presented are not adjusted and continue to be reported in accordance with the Company’s historical accounting policy. Refer to note 6, “Right-of-use asset and lease liabilities” for further information. 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 thera |
Collaboration arrangements and
Collaboration arrangements and concentration of credit risk | 12 Months Ended |
Dec. 31, 2019 | |
Collaboration arrangements and concentration of credit risk | |
Collaboration arrangements and concentration of credit risk | 3. Collaboration arrangements and concentration of credit risk In the years ended December 31, 2019, and 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 due to the combination of its equity investment in the Company (December 31, 2019: 2.4 million ordinary shares or 5.5% of outstanding ordinary shares), the warrants as well as the obligations arising from the collaboration and license agreement the Company and BMS entered into in May 2015. 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, 2019 2018 2017 (in thousands) Bristol Myers Squibb $ 7,281 $ 11,284 $ 8,461 Chiesi Farmaceutici S.p.A (terminated in 2017) — — 4,646 Total $ 7,281 $ 11,284 $ 13,107 Amounts owed by BMS in relation to the collaboration services are as follows: December 31, December 31, 2019 2018 (in thousands) Bristol Myers Squibb $ 947 $ 233 Total $ 947 $ 233 BMS collaboration In May 2015, the Company entered into a collaboration and license agreement (the “BMS CLA”) and various related agreements with BMS that provide BMS with exclusive access to the Company’s gene therapy technology platform for the research, development and commercialization of therapeutics aimed at multiple targets in cardiovascular and other diseases (“Collaboration Targets”). During the initial research term of the BMS CLA, the Company supported BMS in discovery, non-clinical, analytical and process development efforts in respect of the Collaboration Targets. For any Collaboration Targets that may be advanced, the Company will be responsible for manufacturing of clinical and commercial supplies using the Company’s vector technologies and industrial, proprietary insect-cell based manufacturing platform. BMS reimburse the Company for all its research and development costs in support of the collaboration during the initial research term, and will lead development, regulatory and commercial activities for any Collaboration Targets that may be advanced. The BMS CLA provides that the companies may collaborate on up to ten Collaboration Targets in total. The Company has agreed to certain restrictions on its ability to work independently of the collaboration, either directly or indirectly through any affiliate or third party, on certain programs that would be competitive with the collaboration programs. BMS initially designated four Collaboration Targets, including S100A1 for congestive heart failure (“AMT-126”). In October 2018, the Company and BMS completed a heart function proof-of-concept study of AMT-126 in a pre-clinical, diseased animal model. The study demonstrated deoxyribonucleic acid delivery and expression of S100A1 in the myocardium, thereby validating the Company’s vector delivery platform in the animal model. The data did not show a benefit on heart function at six months and, consequently, the Joint Steering Committee for the collaboration decided to discontinue work on S100A1. The Company impaired a $5.4 million acquired research and development asset associated with the program and released a contingent liability of $3.8 million related to the acquisition of the asset to income in the year ended December 31, 2018. In April 2019, BMS designated a new cardiovascular Collaboration Target to replace S100A1. As a result, BMS has designated a total of four Collaboration Targets as of December 31, 2019. The initial four-year research term under the collaboration terminated on May 21, 2019. In February 2019, BMS requested a one-year extension of the research term. In April 2019, following an assessment of the progress of this collaboration and the Company’s expanding proprietary programs, the Company notified BMS that the Company did not intend to agree to an extension of the research term but rather preferred to restructure or amend the collaboration to reduce or eliminate certain of the Company’s obligations under it. Accordingly, the Company is currently in discussions with BMS potentially to restructure or amend the BMS CLA and other related agreements. It is currently uncertain whether a change to the BMS CLA will be agreed and, if agreed, what the specific terms of any such change may be. As a consequence, the Company has not taken into account the impact of such change, if any, on the timing of recognition of the prepaid License Revenue if and when the BMS CLA and other related agreements have been restructured or amended. The final resolution of these discussion may or may not result in material changes to the Company’s collaboration with BMS. The Company evaluated the BMS CLA 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 Collaboration Target specific, non-clinical, analytical and process development services during the initial research term, which ended on May 21, 2019 (“Collaboration Revenue”); and (iii) Providing clinical and commercial manufacturing services for Collaboration Targets (“Manufacturing Revenue”). To date the Company has not generated any Manufacturing Revenue. During the aforementioned discussions with BMS potentially to restructure or amend the BMS CLA and other related agreements, which may be terminated by the Company or BMS at any time, the Company agreed, subject to certain conditions, to continue providing support of the pre-clinical Collaboration Targets, and any related costs will be reimbursed by BMS. License Revenue – BMS The Company recognized $5.0 million of License Revenue for the year ended December 31, 2019 (December 31, 2018: $7.5 million, December 31, 2017: $4.1 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 Targets in August 2015 (together “Consideration”). The Company would be entitled to an aggregate $16.5 million in target designation payments upon the selection of the fifth through tenth Collaboration Targets. The Company would also be eligible to receive research, development and regulatory milestone payments of up to $254.0 million for a lead Collaboration Target and up to $217.0 million for each of the other selected Collaboration Targets, if defined milestones are achieved. The Company would 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 reversal of cumulative revenue recognized. The Company would 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 Collaboration Targets 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 Collaboration Targets being designated by 10% then the revenue for the annual period ended December 31, 2019 would have decreased by approximately $1.9 million, as the Company would be required to render more services in relation to the Consideration received. Collaboration Revenue – BMS The Company recognizes Collaboration Revenues associated with pre-clinical Collaboration Target specific, non-clinical, analytical and process development activities that are reimbursable by BMS under its collaboration agreement during the initial research term (that ended on May 21, 2019). The Company is currently in discussions with BMS potentially to restructure or amend the collaboration and license agreement and other related agreements following the expiration of the research term. During these discussions, which may be terminated by the Company or BMS at any time, the Company has agreed to continue providing support of the pre-clinical Collaboration Targets, and any related costs will be reimbursed by BMS. The Company has provided target-specific research and development services to BMS, and, subject to the outcome of the discussions with BMS, may continue to do so. Collaboration Revenue related to these contracted services is recognized when performance obligations are satisfied. The Company generated $2.3 million collaboration revenue for the year ended December 31, 2019 (December 31, 2018: $3.8 million; December 31, 2017: $4.3 million). Manufacturing Revenue – BMS BMS and the Company also entered into a Master Clinical Supply Agreement in April 2017 for the Company to supply gene therapy products during the clinical phase 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, 2019 (December 31, 2018: nil; December 31, 2017: $0.0 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, 2019 (December 31, 2018: nil; December 31, 2017: $4.6 million) from the co-development of hemophilia B. |
Fair value measurement
Fair value measurement | 12 Months Ended |
Dec. 31, 2019 | |
Fair value measurement | |
Fair value measurement | 4. 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 as of December 31, 2019 inputs consisted of derivative financial instruments. Changes in Level 3 items during the years ended December 31, 2019, 2018 and 2017 are as follows: Derivative Contingent financial consideration instruments Total (in thousands) Balance at December 31, 2016 $ 1,838 $ 62 $ 1,900 Exercises of convertible loan warrants — (631) (631) Net 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 Net 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 Net losses recognized in profit or loss — 2,530 2,530 Exercise of warrants — (770) (770) Currency translation effects — (60) (60) Balance at December 31, 2019 $ — $ 3,075 $ 3,075 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. BMS warrants Pursuant to the BMS CLA, 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 BMS CLA) associated with the first six new targets (a total of seven Collaboration Targets); and (ii) the date on which BMS designates the sixth new target (the seventh Collaboration 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 the Company receives from BMS the Target Designation Fees associated with the first nine new targets (a total of ten Collaboration Targets); and (ii) the date on which BMS designates the ninth new target (the tenth Collaboration Target). As of December 31, 2019, BMS had designated a total of four Collaboration Targets, and as such, the warrants were not exercisable. Pursuant to the terms of the BMS CLA 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% (or approximately $52.39 as of December 31, 2019) 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, 2019 is $3.1 million (December 31, 2018: $0.8 million). During the year ended December 31, 2019, the Company recognized a $2.3 million loss in non-operating income / expense (December 31, 2018: $0.5 million gain; December 31, 2017: $1.2 million loss) related to fair value changes of the BMS warrants. As of December 31, 2019, BMS had designated a total of four Collaboration Targets, and as such, the warrants were not exercisable. The Company estimated the exercise of the warrants to occur within two 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 historical Company volatility, 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 value of the warrants by increasing the volatility by 10% to 82.5%. A further sensitivity analysis was performed assuming the warrants would be exercised a year later than currently estimated. The table below illustrates the impact on the fair market valuation associated with these changes in assumptions as of December 31, 2019. Total warrants in thousands Base case $ 3,075 Increase volatility by 10% to 82.5% 680 Extend exercise dates by one year (31) 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 Hercules warrants were exercised as of February 1, 2019. The Company issued 37,175 ordinary shares at $34.25 following the exercise of all Hercules warrants and receipt of $0.5 million from Hercules. As a result, the fair value of this derivative, recorded in other current liabilities, as of December 31, 2019 is nil (December 31, 2018: $0.6 million). During the year ended December 31, 2019, the Company recognized a $0.2 million loss in other non-operating income / (expense) (December 31, 2018: $0.3 million loss; December 31, 2017: $0.3 million loss) related to fair value changes of the Hercules warrants. 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. Following the discontinuation of the research program the Company since 2018 no longer expects 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, 2019 amounted to nil (December 31, 2018: nil). 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 expenses 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. |
Property, plant and equipment,
Property, plant and equipment, net | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019 2018 in thousands Leasehold improvements $ 34,611 $ 32,462 Laboratory equipment 18,232 16,685 Office equipment 4,212 2,853 Construction-in-progress 341 73 Total property, plant, and equipment 57,396 52,073 Less accumulated depreciation (28,625) (22,894) Property, plant and equipment, net $ 28,771 $ 29,179 Total depreciation expense was $6.0 million for the year ended December 31, 2019 (December 31, 2018: $6.5 million, December 31, 2017: $7.0 million). Depreciation expense is allocated to research and development expenses 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, 2019 2018 in thousands Lexington, Massachusetts (United States of America) $ 15,490 $ 14,598 Amsterdam (the Netherlands) 13,281 14,581 Total $ 28,771 $ 29,179 |
Right-of-use asset and lease li
Right-of-use asset and lease liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Right-of-use asset and lease liabilities | |
Right-of-use asset and lease liabilities | 6. Right-of-use asset and lease liabilities The Company adopted ASU 2016-02 “Leases (Topic 842)” as well as ASU 2018-10 and ASU 2018-11, which both relate to improvements to ASC 842. The Company adopted the standard using the modified retrospective approach with an effective date as of the beginning of the Company’s fiscal year, January 1, 2019 (“new lease accounting standard”). The standard requires the balance sheet recognition for leases. Prior years were not recast under the new standard and therefore, those amounts are presented in accordance with the requirements of the previously effective lease standard ASC 840 (“historic lease accounting standard”). The Company elected to utilize practical expedients available for expired or existing contracts which allowed the Company to carryforward historical assessments of (1) whether contracts are or contain leases, (2) lease classification, and (3) initial direct costs. The Company’s most significant leases relate to office and laboratory space under the following operating lease agreements: Lexington, Massachusetts / United States In July 2013, the Company 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 starting from the 2014 rent commencement date 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 lease of the expansion space commenced on June 1, 2019. The contractually fixed annual increase of lease payments through 2029 for both the extension and expansion lease have been included in the lease payments. 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 includes variable lease payments related to annual increases in payments 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 fixed lease payments to be received during the remaining eight-year term amount to $8.9 million (EUR 7.9 million) as of December 31, 2019. Operating lease liabilities The components of lease cost in accordance with the new lease accounting standard were as follows: Year ended December 31, 2019 (in thousands) Operating lease cost $ 4,474 Variable lease cost 507 Sublease income (1,053) Total lease cost $ 3,928 The rent expense in accordance with the historical lease accounting standard for the years ended December 31, 2018, and December 31, 2017 was 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: Year ended December 31, 2018 2017 Rent expense-Lexington $ 1,583 $ 1,103 Rent expense-Amsterdam 1,667 2,503 Total rent expense $ 3,250 $ 3,606 The table below presents the lease-related assets and liabilities recorded on the Consolidate balance sheet in accordance with the new lease accounting standard. December 31, 2019 (in thousands) Assets Operating lease right-of-use assets $ 26,797 Liabilities Current Current operating lease liabilities 5,865 Non-current Non-current operating lease liabilities 31,133 Total lease liabilities $ 36,998 Other information The weighted-average remaining lease term as of December 31, 2019 is 10.3 years and the weighted-average discount rate as of this date is 11.33% . The table below presents supplemental cash flow and non-cash information related to leases required in accordance with the new lease accounting standard. Year ended December 31, 2019 (in thousands) Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases 1) $ 4,717 Right-of-use asset obtained in exchange for lease obligation Operating lease 2) $ 9,002 ( 1) ( 2) Undiscounted cash flows The table below reconciles the undiscounted cash flows as of December 31, 2019, for each of the first five years and the total of the remaining years to the operating lease liabilities recorded on the Consolidated balance sheet as of December 31, 2019 in accordance with the new lease accounting standard. Lexington Amsterdam 1) Other 1) Total (in thousands) 2020 $ 3,360 $ 2,365 $ 141 $ 5,866 2021 3,455 1,892 141 5,488 2022 3,552 1,892 — 5,444 2023 3,650 1,892 — 5,542 2024 4,146 1,892 — 6,038 Thereafter 20,745 13,084 — 33,829 Total lease payments $ 38,908 $ 23,017 $ 282 $ 62,207 Less: amount of lease payments representing interest payments (15,014) (10,178) (17) (25,209) Present value of lease payments 23,894 12,839 265 36,998 Less: current operating lease liabilities (3,360) (2,364) (141) (5,865) Non-current operating lease liabilities $ 20,534 $ 10,475 $ 124 $ 31,133 (1) Payments are due in EUR and have been translated at the foreign exchange rate as of December 31, 2019, of $1.12 / €1.00) As of December 31, 2018, aggregate minimum lease payments under the historical accounting standard ASC 840 (excluding payments from the sub-lease agreement) for the calendar years and lease incentives received were as follows: Lexington Amsterdam 1) 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 |
Intangible assets
Intangible assets | 12 Months Ended |
Dec. 31, 2019 | |
Intangible assets | |
Intangible assets | 7. Intangible assets a. Acquired licenses The following table presents the Company’s acquired licenses as of December 31: December 31, December 31, 2019 2018 (in thousands) Licenses $ 8,317 $ 7,528 Less accumulated amortization and impairment (2,890) (2,327) Licenses, net $ 5,427 $ 5,201 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 10.7 years as of December 31, 2019. During the year ended December 31, 2019, the Company capitalized $1.0 million of expenditures related to contractual milestone payments under existing license agreements. During the year ended December 31, 2018, the Company capitalized $1.9 million of expenditures related to . As of December 31, 2019, the estimated future amortization expense for each of the five succeeding years and the period thereafter is as follows: Years Amount in thousands 2020 $ 582 2021 573 2022 545 2023 545 2024 515 Thereafter 2,667 Total $ 5,427 The carrying amount of the Company’s licenses by licensor is set out below. December 31, December 31, 2019 2018 in thousands Protein Sciences Corporation $ 1,911 $ 2,084 St. Jude Children’s Hospital 1,404 633 Other 2,112 2,484 Total $ 5,427 $ 5,201 The amortization expense related to licenses for the year ended December 31, 2019 was $0.6 million (December 31, 2018: $0.4 million; December 31, 2017: $1.0 million). b. 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. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Accrued expenses and other current liabilities | |
Accrued expenses and other current liabilities | 8. Accrued expenses and other current liabilities Accrued expenses and other current liabilities include the following items: December 31, December 31, 2019 2018 (in thousands) Accruals for services provided by vendors-not yet billed $ 5,425 $ 1,999 Personnel related accruals and liabilities 7,032 5,688 Derivative financial liability warrants (see note 4) — 545 Total $ 12,457 $ 8,232 |
Long-term debt
Long-term debt | 12 Months Ended |
Dec. 31, 2019 | |
Long-term debt | |
Long-term debt | 9. 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 was adjustable and was 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 30, 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 was initially extended from November 2018 to January 1, 2021. The interest-only period was further extended to January 1, 2022 as a result of meeting the provision in the 2018 Amended Facility of raising more than $90.0 million in equity financing. The Company met this provision as a result of the follow-on public offering completed in September 2019. 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 million 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 (including interest due presented as part of accrued expenses and other current liabilities) of the 2018 Amended Facility was $36.3 million as of December 31, 2019, compared to $35.7 million as of December 31, 2018, and is recorded net of discount and debt issuance costs. The foreign currency loss on the loan was $0.7 million in 2019 (2018: loss of $0.9 million; 2017: gain of $2.6 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 2019 $ 3.7 2018 2.0 2017 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 65% of the outstanding balance of principal due or 100% of worldwide cash and cash equivalents. This restriction on cash and cash equivalents only relates to the location of the cash and cash equivalents, and such cash and cash equivalents 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, 2019, the Company was in compliance with all covenants and provisions. The aggregate maturities of the loan, including $11.5 million of coupon interest payments and financing fees, for each of the 41 months subsequent to December 31, 2019, are as follows: Years Amount in thousands 2020 $ 4,119 2021 3,141 2022 25,002 2023 14,269 Total $ 46,531 |
Shareholders' equity
Shareholders' equity | 12 Months Ended |
Dec. 31, 2019 | |
Shareholders' equity | |
Shareholders' equity | 10. Shareholders’ equity As of December 31, 2019, the Company’s authorized share capital is €3.0 million (exchange rate as of December 31, 2019, of $1.12 / €1.00; $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, 2019, and 2018 and 2017 the Company’s reserves were restricted for payment of dividends for accumulated foreign currency translation losses of $6.7 million, $7.3 million and $3.8 million, respectively. On May 7, 2018, the Company completed a follow-on public offering of 5,175,000 ordinary shares at a public offering price of $28.50 per ordinary share, resulting in gross proceeds to the Company of $147.5 million. The net proceeds to the Company from this offering were $138.4 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. The Company deducted $0.2 million of expenses incurred related to this offering from additional paid-in capital in the accompanying consolidated balance sheet and reflected this within the proceeds from public offering of shares, net of issuance costs within the cash flows from financing activities. On October 27, 2017, the Company completed a follow-on public offering of 5,000,000 ordinary shares at a public offering price of $18.25 per ordinary share, resulting in gross proceeds to the Company of $91.3 million. The net proceeds to the Company from this offering were $85.3 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. The Company deducted $0.5 million of expenses incurred related to this from additional paid in capital in the accompanying consolidated balance sheet and reflected this within the proceeds from public offering of shares, net of issuance costs within the cash flows from financing activities. In February 2019 the Company issued 37,175 ordinary shares to Hercules pursuant to exercised warrants for $0.5 million in aggregate cash consideration. The Company deemed the sale and issuance of these shares to be exempt from registration under the Securities Act in reliance on Regulation S of the Securities Act, as an offshore offering of securities and such shares were issued as restricted shares. Hercules represented to us that they were in compliance with the requirements of Regulation S. 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. In 2017, certain of these lenders (Forbion and Coller) qualified as related parties to the Company at the time of the transaction. On October 2, 2017, the Company issued 64,648 ordinary shares to the sellers of the Inocard business in connection with the amended purchase agreement by which the Company acquired the Inocard business. No cash consideration was paid for the shares, as such shares were issued as amended consideration for the previous acquisition of the Inocard business. The Company deemed the offer and issuance of these shares to be exempt from registration under the Securities Act in reliance on Regulation S of the Securities Act, as an offshore offering of securities and such shares were issued as restricted shares. The sellers of the Inocard business represented to the Company that they were in compliance with the requirements of Regulation S. 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, 2019 | |
Share-based compensation | |
Share-based compensation | 11. Share-based compensation Share-based compensation expense recognized by classification included in the consolidated statements of operations and comprehensive loss was as follows: Year ended December 31, 2019 2018 2017 (in thousands) Research and development $ 8,029 $ 3,994 $ 3,945 Selling, general and administrative 9,439 6,699 6,335 Total $ 17,468 $ 10,693 $ 10,280 Share-based compensation expense recognized by award type was as follows: Year ended December 31, 2019 2018 2017 (in thousands) Award type Share options $ 7,896 $ 4,766 $ 3,246 Restricted share units (“RSUs”) 4,117 3,020 2,588 Performance share units (“PSUs”) 5,455 2,907 4,446 Total $ 17,468 $ 10,693 $ 10,280 As of December 31, 2019, the unrecognized compensation cost related to unvested awards under the various share-based compensation plans were: Unrecognized Weighted average share-based remaining compensation period for expense recognition (in thousands) (in years) Award type Share options $ 19,750 2.90 Restricted share units 7,035 1.90 Performance share units 5,711 1.78 Total $ 32,496 2.49 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 terms similar to the 2014 Plan (together the “2014 Plans”). The Company previously had a 2012 Equity Incentive Plan (the “2012 Plan”). 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 priced 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 years two, three and four. 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. 2014 Plan The following tables summarize option activity under the Company’s 2014 Plans for the year ended December 31, 2019: Options Number of Weighted average Weighted average Aggregate intrinsic ordinary shares exercise price remaining contractual life value in years (in thousands) Outstanding at December 31, 2018 2,673,712 $ 15.09 7.98 $ 39,616 Granted 647,526 $ 40.31 Forfeited (202,926) $ 20.09 Expired (543) $ 12.26 Exercised (434,665) $ 11.91 Outstanding at December 31, 2019 2,683,104 $ 21.29 7.46 135,238 Thereof, fully vested and exercisable at December 31, 2019 1,336,767 $ 13.76 6.62 77,394 Thereof, outstanding and expected to vest at December 31, 2019 1,346,337 $ 28.76 8.29 57,844 Outstanding and expected to vest at December 31, 2018 1,599,797 $ 17.96 Total weighted average grant date fair value of options issued during the period (in $ millions) $ 15.3 Granted to directors and officers during the period (options, grant date fair value $ in millions) 223,097 $ 4.1 Proceeds from option sales during the period (in $ millions) $ 5.2 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, 2019 647,526 $ 23.57 Granted, 2018 937,832 15.90 Granted, 2017 1,295,350 3.87 Vested, 2019 698,127 10.38 Forfeited, 2019 (202,926) 12.09 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, 2019 1,346,337 $ 17.05 Outstanding and expected to vest, 2018 1,599,797 10.83 The fair value of each option issued is estimated at the respective grant date using the Hull & White option pricing model with the following weighted-average assumptions: Year ended December 31, Assumptions 2019 2018 2017 Expected volatility 70%-75% 75%-80% 75%-80% Expected terms 10 years 10 years 10 years Risk free interest rate 1.92% - 2.87% 2.67% - 3.20% 2.39% - 2.81% Expected dividend yield 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 2019 434,665 $ 17,700 2018 388,203 7,515 2017 198,552 1,291 Restricted Share Units (RSUs) The following table summarizes the RSU activity for the year ended December 31, 2019: RSU Weighted average Number of grant-date fair ordinary shares value Non-vested at December 31, 2018 412,321 $ 16.49 Granted 198,504 $ 38.63 Vested (205,583) $ 15.31 Forfeited (34,412) $ 20.62 Non-vested at December 31, 2019 370,830 $ 28.62 Total weighted average grant date fair value of RSUs granted during the period (in $ millions) $ 7.7 Granted to directors and officers during the period (shares, $ in millions) 109,349 $ 4.0 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 2019 198,504 $ 38.63 2018 262,599 23.61 2017 603,350 5.86 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) 2019 $ 10,152 2018 8,546 2017 2,917 RSUs vest over one to three years . RSUs granted to non-executive directors will vest one year from the date of grant. Performance Share Units (PSUs) The following table summarizes the PSU activity for the year ended December 31, 2019: PSU Weighted average Number of grant-date fair ordinary shares value Non-vested at December 31, 2018 377,169 $ 16.73 Granted 132,362 $ 31.71 Vested (30,109) $ 11.83 Non-vested at December 31, 2019 479,422 $ 21.17 PSUs awarded but not yet earned 83,489 $ 71.66 Total non-vested and discretionary PSUs 562,911 $ 28.66 Total weighted average grant date fair value of PSUs granted and awarded during the period (in $ millions) $ 10.2 In January 2019, the Company awarded PSUs to its executives and other members of senior management. These PSUs were earned in January 2020 based on the Board’s assessment of the level of achievement of agreed upon performance targets through December 31, 2019. The PSUs awarded for the year ended December 31, 2019 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 2019 132,362 $ 31.71 2018 — $ — 2017 550,570 $ 17.15 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) 2019 $ 1,056 2018 1,350 2017 1,730 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. During the year ended December 31, 2019, 9,202 shares have been issued (December 31, 2018: 2,591). As of December 31, 2019, a total of 138,207 ordinary shares remains available for issuance under the ESPP plan. 2012 Plan The following table summarizes option activity under the Company’s 2012 Plan for the year ended December 31, 2019: 2012 plan Weighted average Weighted average Aggregate intrinsic Options exercise price remaining contractual life value in years (in thousands) Outstanding at December 31, 2018 32,567 € 5.23 3.62 $ 939 Exercised (18,567) € 3.07 Forfeited — € — Expired — € — Outstanding, fully vested and exercisable at December 31, 2019 14,000 € 8.09 3.10 876 Proceeds from option sales (in million) $ 0.1 The following table summarizes information about options exercised during the years ended December 31: Exercised during the year Intrinsic value (in thousands) 2019 18,567 $ 1,014 2018 40,251 964 2017 405,188 1,176 |
Expenses by nature
Expenses by nature | 12 Months Ended |
Dec. 31, 2019 | |
Expenses by nature | |
Expenses by nature | 12. Expenses by nature Operating expenses excluding expenses presented in other expenses included the following expenses by nature: Years ended December 31, 2019 2018 2017 (in thousands) Employee-related expenses $ 59,130 $ 46,254 $ 46,373 Laboratory and development expenses 30,130 23,596 17,737 Office and housing expenses 10,588 7,281 9,327 Legal and advisory expenses 11,297 7,748 8,121 Depreciation, amortization and impairment expenses 6,669 12,415 6,779 Patent and license expenses 1,654 1,202 817 Other operating expenses 8,813 1,618 7,653 Total $ 128,281 $ 100,114 $ 96,807 Details of employee-related expenses for the years ended December 31 are as follows: Years ended December 31, 2019 2018 2017 in thousands, except for employee numbers Wages and salaries $ 32,029 $ 26,646 $ 25,131 Share-based compensation expenses 17,533 10,708 10,280 Consultant expenses 2,464 2,974 4,758 Social security costs 2,727 2,231 2,077 Health insurance 1,933 1,750 1,536 Pension costs-defined contribution plans 650 628 802 Other employee expenses 1,794 1,317 1,789 Total $ 59,130 $ 46,254 $ 46,373 Number of employees at the end of the period 248 212 202 |
Other non-operating income _ (e
Other non-operating income / (expense) | 12 Months Ended |
Dec. 31, 2019 | |
Other non-operating income / (expense) | |
Other non-operating income / (expense) | 13. 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, 2019 2018 2017 (in thousands) Other non-operating income: Derivative gains $ — $ 208 $ — Total other non-operating income: — 208 — Other non-operating expense: Derivative losses (2,530) — (2,192) Finance expenses — — (243) Total other non-operating expense: (2,530) — (2,435) Other non-operating income / (expense), net $ (2,530) $ 208 $ (2,435) The Company recorded a net loss of $2.3 million for the year ended December 31, 2019, compared to a net gain of $0.5 million and a net loss of $1.2 million for the years ended December 31, 2018 and December 31, 2017, respectively, related to the derivative financial instruments issued as part of its collaboration with BMS and a net loss of $0.2 million for the year ended December 31, 2019 (December 31, 2018: $0.3 million net loss; December 31, 2017: $0.3 million net loss) related to warrants issued to Hercules (see note 4, “Fair value measurement”). Also, the Company recognized a $0.7 million loss for the year ended December 31, 2017, related to warrants issued in connected with the 2013 convertible loan. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income taxes | |
Income taxes | 14. Income taxes a. Income tax benefit / (expense) No current For the years ended December 31, 2019, 2018 and 2017, loss before income taxes consists of the following: Years ended December 31, 2019 2018 2017 (in thousands) Dutch operations $ (111,820) $ (85,721) $ (60,966) U.S. operations (12,381) 2,646 (18,493) Foreign operations — 3 — Total $ (124,201) $ (83,073) $ (79,459) The income tax benefit / (expense) for the years ended December 31, 2019, 2018 and 2017, consists of the following: Years ended December 31, 2019 2018 2017 (in thousands) Current tax (expense) / benefit Dutch operations $ — $ — $ — U.S. operations — — — Foreign operations — (22) (10) Total current income tax (expense) / benefit $ — $ (22) $ (10) Deferred tax (expense) / benefit Dutch operations $ — $ (209) $ 209 U.S. operations — — — Foreign operations — — — Total deferred income tax (expense) / benefit $ — $ (209) $ 209 Total income tax (expense) / benefit $ — $ (231) $ 199 b. Tax rate reconciliation The reconciliation of the amount of income tax benefit / (expense) that would result from applying the Dutch statutory income tax rate to the Company’s reported amount of income tax benefit / (expense) for the years ended December 31, 2019, 2018 and 2017, is as follows: Years ended December 31, 2019 2018 2017 (in thousands) Loss before income tax expense for the period $ (124,201) $ (83,073) $ (79,459) Expected income tax benefit at the tax rate enacted in the Netherlands (25%) 31,050 20,768 19,865 Difference in tax rates between the Netherlands and foreign countries (495) (106) 1,664 Net change in valuation allowance (25,583) (19,207) (17,358) Non-deductible expenses (4,972) (2,648) (3,248) Change in fair value of contingent consideration — 962 (724) Income tax (expense) / benefit $ — $ (231) $ 199 Non-deductible expenses predominantly relate to share-based compensation expenses for an amount of $4.4 million in 2019 (2018: $2.7 million; 2017: $2.5 million) and non-deductible results on derivative financial instruments of $0.6 million (2018: $0.0 million; 2017: $0.5 million). c. The tax effects of temporary differences and carryforwards that give rise to significant portions of deferred tax assets and deferred tax liabilities at December 31, 2019 and 2018 are as follows: Years ended December 31, 2019 2018 (in thousands) Deferred tax assets: Net operating loss carryforwards $ 99,644 $ 74,529 Intangible assets 770 847 Lease liabilities 7,861 — Property, plant and equipment 761 561 Deferred revenue 6,676 7,481 Accrued expenses and other current liabilities 628 1,682 Gross deferred tax asset $ 116,340 $ 85,100 Less valuation allowance (109,856) (85,100) Net deferred tax asset $ 6,484 $ — Right-of-use asset (6,484) — Net deferred tax liability $ (6,484) $ — Net deferred tax asset / (liability) $ — $ — Changes in the valuation allowance were as follows: Years ended December 31, 2019 2018 2017 (in thousands) January 1, $ 85,100 $ 93,682 $ 82,642 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 25,583 19,207 19,080 Increase/(Reduction) related to 2019 and 2018, respectively, Dutch tax reforms 4,059 (15,670) — Reduction related to 2017 US tax reform — — (1,722) Other changes including currency translation effects (4,886) (5,890) (6,318) December 31, $ 109,856 $ 85,100 $ 93,682 Included within changes recorded in profit and loss for the year ended December 31, 2019 is the utilization of $3.7 million of U.S. net operating loss carryforwards ($4.5 million utilization for the year ended December 31, 2018 and $0.0 for the year ended December 31, 2017). The valuation allowance at December 31, 2019 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. There is also a portion of the valuation allowance for deferred tax assets for which subsequently measured tax benefits will be credited directly to contributed capital as it relates to follow-on offering costs. As of December 31, 2019, that amount was $6.9 million ($3.3 million as of December 31, 2018). In the Netherlands, changes to corporate taxes were enacted in December 2019. The changes increase the corporate tax rate from 22.55% to 25.00% for the fiscal year 2020 and decrease the corporate tax rate to 21.7%, effective January 1, 2021. The Company remeasured its deferred tax assets and liabilities using a rate of 21.7% instead of the 20.5% rate effective in 2019 as it does not expect to utilize any of its loss carryforwards prior to 2021. This resulted in a $4.1 million increase of both the gross deferred tax asset and the valuation allowance in the year ended December 31, 2019. A tax reform in December 2018 limited 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 2018 Dutch tax reform had initially lowered the tax rate from 25.0% to 20.5%. This rate reduction was partially reversed through the 2019 Dutch tax reform. The Dutch fiscal unity has as of December 31, 2019 an estimated $414.0 million (2018: $311.7 million; 2017: $246.0 million) of taxable losses that can be offset in the following six losses are summarized in the following table. In the year ended December 31, 2019 unused tax losses of $20.7 million (December 31, 2018: $20.0 million) expired. 2020 2021 2022 2023 2024-2027 (in thousands) Loss expiring $ 18,479 $ 13,905 $ 23,664 $ 23,047 $ 334,859 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, 2019, the estimated remaining tax losses available for carry forward are $46.7 million. These losses will expire between 2035 and 2037. Under the provision of the Internal Revenue Code, the U.S. net operating losses 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 significant unrecognized tax benefits as of December 31, 2019 and 2018. |
Basic and diluted earnings per
Basic and diluted earnings per share | 12 Months Ended |
Dec. 31, 2019 | |
Basic and diluted earnings per share | |
Basic and diluted earnings per share | 15. 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, 2019 2018 2017 (ordinary shares) BMS warrants 8,893,000 8,575,000 6,800,000 Stock options under 2014 Plans 2,683,104 2,673,712 2,456,433 Non-vested RSUs and earned PSUs 850,252 789,490 1,194,737 Stock options under 2012 Plan 14,000 32,567 72,818 Hercules warrants (exercised February 1, 2019) — 37,175 37,175 Employee share purchase plan 485 1,012 — Total potential dilutive ordinary shares 12,440,841 12,108,956 10,561,163 |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and contingencies | |
Commitments and contingencies | 16. 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, 2019 | |
Related party transaction | |
Related party transaction | 17. Related party transaction On August 20, 2019, the Company promoted Sander van Deventer, M.D., Ph.D., to Executive Vice President, Research and Product Development, and Alex Kuta, Ph.D., to Executive Vice President, Operations. Dr. van Deventer, in addition to his responsibilities for research, will now also be responsible for the Company’s product development. Dr. Kuta, in addition to regulatory affairs, will now also be responsible for global quality as well as GMP manufacturing at uniQure’s state-of-the-art facility in Lexington, Massachusetts. As a result of these changes, the Company eliminated the Chief Operating Officer role, and Scott McMillan, Ph.D. retired from uniQure. In August 2019, the Company entered into an Amended and Restated Agreement Collaboration and License Agreement (“Amended CLA”) as well as an additional new Collaboration and License Agreement (“New CLA”) with its related party 4DMT Molecular Therapeutics, Inc. (“4DMT”). In the Amended CLA, the Company received from 4DMT an exclusive, sublicensable, worldwide license under certain 4DMT intellectual property rights to research, develop, make, use, and commercialize previously selected AAV capsid variants and certain associated products using 4DMT proprietary AAV technology for delivery of gene therapy constructs to cells in the central nervous system and the liver (“the Field”). In the New CLA, the parties agreed to research and develop, at 4DMT’s cost, new AAV capsid variants using 4DMT proprietary AAV technology for delivery of up to six additional transgene constructs in the Field that will be selected by the Company. 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, 2019 | |
Subsequent events | |
Subsequent events | 18. Subsequent events None. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019 and the Company’s budgeted cash flows for the twelve months following the issuance date. |
Use of estimates | 2.2 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 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 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 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, if any. |
Foreign currency translation | 2.3.3 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. |
Fair value measurement | 2.3.4 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 ● 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 4, “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 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 4, “Fair value measurement,” for additional information. |
Notes to the consolidated statements of cash flows | 2.3.6 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 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 The Company follows the provisions of ASC 260, Earnings Per Share 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 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. Right-of-use assets are also reviewed for impairment in accordance with ASC 360. 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 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 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 Deposits 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 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 are amounts paid in the period, for which the benefit has not been realized, and include payments made for insurance and research and clinical contracts. The related expense will be recognized in the subsequent period as incurred. |
Accounts payable and accrued expenses | 2.3.15 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 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 The Company accounts for its share-based compensation awards in accordance with ASC 718, Compensation-Stock Compensation. 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. The requirements of ASC 718 are also applied to nonemployee share-based payment transactions except for specific guidance on certain inputs to an option-pricing model and the attribution of cost. 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 3 “Collaboration arrangements and concentration of credit risk” for additional information. Revenue recognition for the year ended December 31, 2017: During the year ended December 31, 2017 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 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 in 2017 is presented as other income in 2017 with no such income in 2018 and 2019. 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 with no such expenses in 2018 and 2019. |
Research and development expenses | 2.3.21 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 are recorded in accordance with ASC 740, Income Taxes 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. Recognized tax positions are measured at the largest amount of tax benefit that is greater than 50 percent likely of being realized upon settlement. 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, 2019, and 2018, the Company did not have any significant unrecognized tax benefits. |
Recent accounting pronouncements | 2.3.23 Recently Adopted Accounting Pronouncements ASC 842 - Leases (Topic 842) 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) – Target Improvements” (ASU 2018-11), which address implementation issues related to the new lease standard. The standard is effective for interim and annual reporting periods beginning after December 15, 2018. Under the new standard, lessees are required to recognize the right-of-use assets and lease liabilities that arise from operating leases on the Consolidated balance sheet. The Company adopted the standard using the modified retrospective approach with an effective date as of the beginning of the Company’s fiscal year, January 1, 2019, to operating leases that existed on that date. Prior year comparative financial information was not recast under the new standard and continues to be presented under ASC 840. The Company elected to utilize the package of practical expedients available for expired or existing contracts which allowed the Company to carryforward historical assessments of (1) whether contracts are or contain leases, (2) lease classification, and (3) initial direct costs. The Company performed an assessment and identified the lease facilities as leases to be accounted for under ASC 842 as of January 1, 2019. The Company elected to implement ASC 842 by applying the modified retrospective approach, which allows the Company to restrict the application of the new guidance to operating leases as of January 1, 2019. The impact of implementing ASC 842 is summarized below: - Recognized a $19.0 million operating right-of-use asset and a $28.1 million operating lease liability in relation to the facilities leased at the Amsterdam and Lexington sites in the Consolidated balance sheet as of January 1, 2019; - Presented deferred rent of $9.1 million as of December 31, 2018, as a reduction of the right-of-use asset as from January 1, 2019 onwards in the Consolidated balance sheet and as a change within operating cash flows within accrued expense, other liabilities and operating leases; The Company measured the lease liability at the present value of the future lease payments as of January 1, 2019. The Company used an incremental borrowing rate to discount the lease payments. The Company derived the discount rate, adjusted for differences such as in the term and payment patterns, from the Company’s loan from Hercules Capital, which was refinanced immediately prior to the January 1, 2019 adoption date in December 2018. The right-of-use asset is valued at the amount of the lease liability reduced by the remaining December 31, 2018 balance of lease incentives received. The lease liability is subsequently measured at the present value of the future lease payments as of the reporting date with a corresponding adjustment to the right-to-use asset. Absent a lease modification, the Company will continue to utilize the January 1, 2019, incremental borrowing rate. The Company will continue to recognize lease cost on a straight-line basis and will continue to present these costs as operating expenses within the Consolidated statements of operations and comprehensive loss. The Company will continue to present lease payments and landlord incentive payments within cash flows from operations within the Consolidated statements of cash flows. The financial results for year ended December 31, 2019, is presented under the new standard, while the comparative periods presented are not adjusted and continue to be reported in accordance with the Company’s historical accounting policy. Refer to note 6, “Right-of-use asset and lease liabilities” for further information. 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 3 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 the Company’s 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 the Company’s 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 the Company’s consolidated financial statements. ASU 2019-07: Codification Updates to SEC Sections In July 2019, the FASB issued ASU 2019-07, Codification Updates to SEC Sections (“ASU 2019-07”), which provides amendments to SEC Paragraphs Pursuant to SEC Final Rule Releases No. 33-10532, Disclosure Update and Simplification, and Nos. 33-10231 and 33-10442, Investment Company Reporting Modernization, and Miscellaneous Updates. The effective date for the standard is upon issuance. ASU 2017-09 did not have a material impact on the Company’s consolidated financial statements. Recent Accounting Pronouncements Not Yet Effective 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 its consolidated financial statements except for the inclusion of potentially additional disclosures for Level 3 inputs. |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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 |
Collaboration arrangements an_2
Collaboration arrangements and concentration of credit risk (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Collaboration arrangements and concentration of credit risk | |
Schedule of collaboration and license revenue | Years ended December 31, 2019 2018 2017 (in thousands) Bristol Myers Squibb $ 7,281 $ 11,284 $ 8,461 Chiesi Farmaceutici S.p.A (terminated in 2017) — — 4,646 Total $ 7,281 $ 11,284 $ 13,107 |
Schedule of amounts owed in relation to collaboration | December 31, December 31, 2019 2018 (in thousands) Bristol Myers Squibb $ 947 $ 233 Total $ 947 $ 233 |
Fair value measurement (Tables)
Fair value measurement (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair value measurement | |
Schedule of changes in Level 3 items | Derivative Contingent financial consideration instruments Total (in thousands) Balance at December 31, 2016 $ 1,838 $ 62 $ 1,900 Exercises of convertible loan warrants — (631) (631) Net 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 Net 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 Net losses recognized in profit or loss — 2,530 2,530 Exercise of warrants — (770) (770) Currency translation effects — (60) (60) Balance at December 31, 2019 $ — $ 3,075 $ 3,075 |
Schedule of changes in fair value of unobservable inputs related to collaboration arrangement | Total warrants in thousands Base case $ 3,075 Increase volatility by 10% to 82.5% 680 Extend exercise dates by one year (31) |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, plant and equipment, net | |
Schedule of property, plant and equipment | December 31, December 31, 2019 2018 in thousands Leasehold improvements $ 34,611 $ 32,462 Laboratory equipment 18,232 16,685 Office equipment 4,212 2,853 Construction-in-progress 341 73 Total property, plant, and equipment 57,396 52,073 Less accumulated depreciation (28,625) (22,894) Property, plant and equipment, net $ 28,771 $ 29,179 |
Summary of long-lived assets by geographic region | December 31, December 31, 2019 2018 in thousands Lexington, Massachusetts (United States of America) $ 15,490 $ 14,598 Amsterdam (the Netherlands) 13,281 14,581 Total $ 28,771 $ 29,179 |
Right-of-use asset and lease _2
Right-of-use asset and lease liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Right-of-use asset and lease liabilities | |
Schedule of lease cost, balance sheet and cash flow information | Year ended December 31, 2019 (in thousands) Operating lease cost $ 4,474 Variable lease cost 507 Sublease income (1,053) Total lease cost $ 3,928 The table below presents the lease-related assets and liabilities recorded on the Consolidate balance sheet in accordance with the new lease accounting standard. December 31, 2019 (in thousands) Assets Operating lease right-of-use assets $ 26,797 Liabilities Current Current operating lease liabilities 5,865 Non-current Non-current operating lease liabilities 31,133 Total lease liabilities $ 36,998 Other information The weighted-average remaining lease term as of December 31, 2019 is 10.3 years and the weighted-average discount rate as of this date is 11.33% . The table below presents supplemental cash flow and non-cash information related to leases required in accordance with the new lease accounting standard. Year ended December 31, 2019 (in thousands) Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases 1) $ 4,717 Right-of-use asset obtained in exchange for lease obligation Operating lease 2) $ 9,002 ( 1) ( 2) |
Summary of aggregate rent expense | Year ended December 31, 2018 2017 Rent expense-Lexington $ 1,583 $ 1,103 Rent expense-Amsterdam 1,667 2,503 Total rent expense $ 3,250 $ 3,606 |
Schedule of undiscounted cash flows and minimum lease payments | Lexington Amsterdam 1) Other 1) Total (in thousands) 2020 $ 3,360 $ 2,365 $ 141 $ 5,866 2021 3,455 1,892 141 5,488 2022 3,552 1,892 — 5,444 2023 3,650 1,892 — 5,542 2024 4,146 1,892 — 6,038 Thereafter 20,745 13,084 — 33,829 Total lease payments $ 38,908 $ 23,017 $ 282 $ 62,207 Less: amount of lease payments representing interest payments (15,014) (10,178) (17) (25,209) Present value of lease payments 23,894 12,839 265 36,998 Less: current operating lease liabilities (3,360) (2,364) (141) (5,865) Non-current operating lease liabilities $ 20,534 $ 10,475 $ 124 $ 31,133 (1) Payments are due in EUR and have been translated at the foreign exchange rate as of December 31, 2019, of $1.12 / €1.00) |
Schedule of minimum lease payments | As of December 31, 2018, aggregate minimum lease payments under the historical accounting standard ASC 840 (excluding payments from the sub-lease agreement) for the calendar years and lease incentives received were as follows: Lexington Amsterdam 1) 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 |
Intangible assets (Tables)
Intangible assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Intangible assets | |
Schedule of finite-lived intangible assets | December 31, December 31, 2019 2018 (in thousands) Licenses $ 8,317 $ 7,528 Less accumulated amortization and impairment (2,890) (2,327) Licenses, net $ 5,427 $ 5,201 |
Schedule of estimated future amortization expense | Years Amount in thousands 2020 $ 582 2021 573 2022 545 2023 545 2024 515 Thereafter 2,667 Total $ 5,427 |
Schedule of acquired licenses | December 31, December 31, 2019 2018 in thousands Protein Sciences Corporation $ 1,911 $ 2,084 St. Jude Children’s Hospital 1,404 633 Other 2,112 2,484 Total $ 5,427 $ 5,201 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accrued expenses and other current liabilities | |
Schedule of accrued expenses and other current liabilities | December 31, December 31, 2019 2018 (in thousands) Accruals for services provided by vendors-not yet billed $ 5,425 $ 1,999 Personnel related accruals and liabilities 7,032 5,688 Derivative financial liability warrants (see note 4) — 545 Total $ 12,457 $ 8,232 |
Long-term debt (Tables)
Long-term debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Long-term debt | |
Schedule of interest expense | Years Amount in millions 2019 $ 3.7 2018 2.0 2017 2.2 |
Schedule of aggregate maturities of the loan | Years Amount in thousands 2020 $ 4,119 2021 3,141 2022 25,002 2023 14,269 Total $ 46,531 |
Share-based compensation (Table
Share-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based compensation | |
Schedule of share-based compensation expense by classification included in consolidated statements of operations and comprehensive loss | Year ended December 31, 2019 2018 2017 (in thousands) Research and development $ 8,029 $ 3,994 $ 3,945 Selling, general and administrative 9,439 6,699 6,335 Total $ 17,468 $ 10,693 $ 10,280 |
Schedule of share-based compensation expense | Year ended December 31, 2019 2018 2017 (in thousands) Award type Share options $ 7,896 $ 4,766 $ 3,246 Restricted share units (“RSUs”) 4,117 3,020 2,588 Performance share units (“PSUs”) 5,455 2,907 4,446 Total $ 17,468 $ 10,693 $ 10,280 |
Schedule of unrecognized compensation cost related to unvested awards | Unrecognized Weighted average share-based remaining compensation period for expense recognition (in thousands) (in years) Award type Share options $ 19,750 2.90 Restricted share units 7,035 1.90 Performance share units 5,711 1.78 Total $ 32,496 2.49 |
Schedule of weighted-average assumptions for fair value of option issued | Year ended December 31, Assumptions 2019 2018 2017 Expected volatility 70%-75% 75%-80% 75%-80% Expected terms 10 years 10 years 10 years Risk free interest rate 1.92% - 2.87% 2.67% - 3.20% 2.39% - 2.81% Expected dividend yield 0% 0% 0% |
Summary of RSUs activity | RSU Weighted average Number of grant-date fair ordinary shares value Non-vested at December 31, 2018 412,321 $ 16.49 Granted 198,504 $ 38.63 Vested (205,583) $ 15.31 Forfeited (34,412) $ 20.62 Non-vested at December 31, 2019 370,830 $ 28.62 Total weighted average grant date fair value of RSUs granted during the period (in $ millions) $ 7.7 Granted to directors and officers during the period (shares, $ in millions) 109,349 $ 4.0 |
Summary of PSUs activity | PSU Weighted average Number of grant-date fair ordinary shares value Non-vested at December 31, 2018 377,169 $ 16.73 Granted 132,362 $ 31.71 Vested (30,109) $ 11.83 Non-vested at December 31, 2019 479,422 $ 21.17 PSUs awarded but not yet earned 83,489 $ 71.66 Total non-vested and discretionary PSUs 562,911 $ 28.66 Total weighted average grant date fair value of PSUs granted and awarded during the period (in $ millions) $ 10.2 |
2014 Plan | |
Share-based compensation | |
Summary of option activity | Options Number of Weighted average Weighted average Aggregate intrinsic ordinary shares exercise price remaining contractual life value in years (in thousands) Outstanding at December 31, 2018 2,673,712 $ 15.09 7.98 $ 39,616 Granted 647,526 $ 40.31 Forfeited (202,926) $ 20.09 Expired (543) $ 12.26 Exercised (434,665) $ 11.91 Outstanding at December 31, 2019 2,683,104 $ 21.29 7.46 135,238 Thereof, fully vested and exercisable at December 31, 2019 1,336,767 $ 13.76 6.62 77,394 Thereof, outstanding and expected to vest at December 31, 2019 1,346,337 $ 28.76 8.29 57,844 Outstanding and expected to vest at December 31, 2018 1,599,797 $ 17.96 Total weighted average grant date fair value of options issued during the period (in $ millions) $ 15.3 Granted to directors and officers during the period (options, grant date fair value $ in millions) 223,097 $ 4.1 Proceeds from option sales during the period (in $ millions) $ 5.2 |
Summary of information about weighted average grant-date fair value of options granted | Weighted average Options grant ‑ date fair value Granted, 2019 647,526 $ 23.57 Granted, 2018 937,832 15.90 Granted, 2017 1,295,350 3.87 Vested, 2019 698,127 10.38 Forfeited, 2019 (202,926) 12.09 |
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, 2019 1,346,337 $ 17.05 Outstanding and expected to vest, 2018 1,599,797 10.83 |
Summary of information about options exercised | Exercised during the year Intrinsic value in thousands 2019 434,665 $ 17,700 2018 388,203 7,515 2017 198,552 1,291 |
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, 2018 32,567 € 5.23 3.62 $ 939 Exercised (18,567) € 3.07 Forfeited — € — Expired — € — Outstanding, fully vested and exercisable at December 31, 2019 14,000 € 8.09 3.10 876 Proceeds from option sales (in million) $ 0.1 |
Summary of information about options exercised | Exercised during the year Intrinsic value (in thousands) 2019 18,567 $ 1,014 2018 40,251 964 2017 405,188 1,176 |
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 2019 198,504 $ 38.63 2018 262,599 23.61 2017 603,350 5.86 |
Summary of information about the total fair value of stock that vested | Total fair value (in thousands) 2019 $ 10,152 2018 8,546 2017 2,917 |
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 2019 132,362 $ 31.71 2018 — $ — 2017 550,570 $ 17.15 |
Summary of information about the total fair value of stock that vested | Total fair value (in thousands) 2019 $ 1,056 2018 1,350 2017 1,730 |
Expenses by nature (Tables)
Expenses by nature (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Expenses by nature | |
Schedule of operating expenses | Years ended December 31, 2019 2018 2017 (in thousands) Employee-related expenses $ 59,130 $ 46,254 $ 46,373 Laboratory and development expenses 30,130 23,596 17,737 Office and housing expenses 10,588 7,281 9,327 Legal and advisory expenses 11,297 7,748 8,121 Depreciation, amortization and impairment expenses 6,669 12,415 6,779 Patent and license expenses 1,654 1,202 817 Other operating expenses 8,813 1,618 7,653 Total $ 128,281 $ 100,114 $ 96,807 |
Schedule of employee-related expenses | Years ended December 31, 2019 2018 2017 in thousands, except for employee numbers Wages and salaries $ 32,029 $ 26,646 $ 25,131 Share-based compensation expenses 17,533 10,708 10,280 Consultant expenses 2,464 2,974 4,758 Social security costs 2,727 2,231 2,077 Health insurance 1,933 1,750 1,536 Pension costs-defined contribution plans 650 628 802 Other employee expenses 1,794 1,317 1,789 Total $ 59,130 $ 46,254 $ 46,373 Number of employees at the end of the period 248 212 202 |
Other non-operating income _ _2
Other non-operating income / (expense) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Other non-operating income / (expense) | |
Schedule of other non-operating income / (expense) | Years ended December 31, 2019 2018 2017 (in thousands) Other non-operating income: Derivative gains $ — $ 208 $ — Total other non-operating income: — 208 — Other non-operating expense: Derivative losses (2,530) — (2,192) Finance expenses — — (243) Total other non-operating expense: (2,530) — (2,435) Other non-operating income / (expense), net $ (2,530) $ 208 $ (2,435) |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income taxes | |
Schedule of loss before income taxes | Years ended December 31, 2019 2018 2017 (in thousands) Dutch operations $ (111,820) $ (85,721) $ (60,966) U.S. operations (12,381) 2,646 (18,493) Foreign operations — 3 — Total $ (124,201) $ (83,073) $ (79,459) |
Schedule of income tax benefit / (expense) | Years ended December 31, 2019 2018 2017 (in thousands) Current tax (expense) / benefit Dutch operations $ — $ — $ — U.S. operations — — — Foreign operations — (22) (10) Total current income tax (expense) / benefit $ — $ (22) $ (10) Deferred tax (expense) / benefit Dutch operations $ — $ (209) $ 209 U.S. operations — — — Foreign operations — — — Total deferred income tax (expense) / benefit $ — $ (209) $ 209 Total income tax (expense) / benefit $ — $ (231) $ 199 |
Schedule of reconciliation of statutory income tax rate to effective tax rate | Years ended December 31, 2019 2018 2017 (in thousands) Loss before income tax expense for the period $ (124,201) $ (83,073) $ (79,459) Expected income tax benefit at the tax rate enacted in the Netherlands (25%) 31,050 20,768 19,865 Difference in tax rates between the Netherlands and foreign countries (495) (106) 1,664 Net change in valuation allowance (25,583) (19,207) (17,358) Non-deductible expenses (4,972) (2,648) (3,248) Change in fair value of contingent consideration — 962 (724) Income tax (expense) / benefit $ — $ (231) $ 199 |
Schedule of significant portions of deferred tax assets and deferred tax liabilities | Years ended December 31, 2019 2018 (in thousands) Deferred tax assets: Net operating loss carryforwards $ 99,644 $ 74,529 Intangible assets 770 847 Lease liabilities 7,861 — Property, plant and equipment 761 561 Deferred revenue 6,676 7,481 Accrued expenses and other current liabilities 628 1,682 Gross deferred tax asset $ 116,340 $ 85,100 Less valuation allowance (109,856) (85,100) Net deferred tax asset $ 6,484 $ — Right-of-use asset (6,484) — Net deferred tax liability $ (6,484) $ — Net deferred tax asset / (liability) $ — $ — |
Summary of Changes in the valuation allowance | Years ended December 31, 2019 2018 2017 (in thousands) January 1, $ 85,100 $ 93,682 $ 82,642 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 25,583 19,207 19,080 Increase/(Reduction) related to 2019 and 2018, respectively, Dutch tax reforms 4,059 (15,670) — Reduction related to 2017 US tax reform — — (1,722) Other changes including currency translation effects (4,886) (5,890) (6,318) December 31, $ 109,856 $ 85,100 $ 93,682 |
Summary of expiration dates for losses | 2020 2021 2022 2023 2024-2027 (in thousands) Loss expiring $ 18,479 $ 13,905 $ 23,664 $ 23,047 $ 334,859 |
Basic and diluted earnings pe_2
Basic and diluted earnings per share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Basic and diluted earnings per share | |
Schedule of potential dilutive common shares | Years ended December 31, 2019 2018 2017 (ordinary shares) BMS warrants 8,893,000 8,575,000 6,800,000 Stock options under 2014 Plans 2,683,104 2,673,712 2,456,433 Non-vested RSUs and earned PSUs 850,252 789,490 1,194,737 Stock options under 2012 Plan 14,000 32,567 72,818 Hercules warrants (exercised February 1, 2019) — 37,175 37,175 Employee share purchase plan 485 1,012 — Total potential dilutive ordinary shares 12,440,841 12,108,956 10,561,163 |
Summary of significant accoun_4
Summary of significant accounting policies (Details) | 12 Months Ended |
Dec. 31, 2019USD ($)segment$ / sharesshares | |
Segment information | |
Number of operating segments | segment | 1 |
Earnings Per Common Share | |
Dilutive securities (in shares) | shares | 0 |
Current and non-current classification | |
Operating cycle period | 12 months |
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 |
Lexington | 401(k) Plan | |
Pensions | |
Amount contributed to plan (in dollars per share) | $ / shares | $ 1 |
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) | 10 years |
Leasehold improvements | Maximum | |
Property, plant and equipment, net | |
Estimated useful life (in years) | 15 years |
Laboratory equipment | |
Property, plant and equipment, net | |
Estimated useful life (in years) | 5 years |
Office equipment | Minimum | |
Property, plant and equipment, net | |
Estimated useful life (in years) | 3 years |
Office equipment | Maximum | |
Property, plant and equipment, net | |
Estimated useful life (in years) | 5 years |
Licenses | |
Intangible assets | |
Estimated useful life (in years) | 20 years |
Summary of significant accoun_5
Summary of significant accounting policies - Recently adopted Accounting Pronouncements (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 01, 2019 | Jan. 01, 2018 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Operating lease right-of-use assets | $ 26,797 | ||||
Operating lease liability | 36,998 | ||||
Deferred rent | $ 9,100 | ||||
Revenue | 7,281 | 11,284 | $ 13,107 | ||
Retained Earnings (Accumulated Deficit) | (659,707) | (535,506) | |||
ASU 2016-02 | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Operating lease right-of-use assets | $ 19,000 | ||||
Operating lease liability | $ 28,100 | ||||
ASU 2014-09 | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Deferred revenue | $ (24,900) | ||||
Retained Earnings (Accumulated Deficit) | $ (24,900) | ||||
License revenues | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Revenue | 8 | ||||
License revenues from related party | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Revenue | $ 4,988 | 7,528 | $ 4,121 | ||
Before Topic 606 | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Revenue | $ 4,200 |
Collaboration arrangements an_3
Collaboration arrangements and concentration of credit risk - BMS collaboration - Narrative (Details) $ in Thousands | May 21, 2015USD ($) | Aug. 31, 2015USD ($) | May 31, 2015item | Dec. 31, 2019USD ($)item | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Collaboration arrangements | ||||||
Revenue | $ 7,281 | $ 11,284 | $ 13,107 | |||
Restricted share units ("RSUs") | ||||||
Collaboration arrangements | ||||||
Upfront payment recorded | 1,200 | |||||
Minimum | ||||||
Collaboration arrangements | ||||||
Decrease in revenue | 1,900 | |||||
License revenues from related party | ||||||
Collaboration arrangements | ||||||
Revenue | 4,988 | 7,528 | 4,121 | |||
Collaboration revenues from related party | ||||||
Collaboration arrangements | ||||||
Revenue | 2,293 | 3,756 | 4,340 | |||
BMS arrangement | ||||||
Collaboration arrangements | ||||||
Revenue | $ 7,281 | 11,284 | 13,107 | |||
BMS arrangement | Bristol Myers Squibb | ||||||
Collaboration arrangements | ||||||
Number of collaboration targets | item | 4 | 4 | ||||
Contingent liability | 3,800 | |||||
Revenue | $ 7,281 | 11,284 | $ 8,461 | |||
BMS arrangement | Bristol Myers Squibb | Maximum | ||||||
Collaboration arrangements | ||||||
Number of collaboration targets | item | 10 | |||||
License revenue | Bristol Myers Squibb | ||||||
Collaboration arrangements | ||||||
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 | |||||
Percentage of increase in probability of all additional targets | 10 | |||||
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 | Fifth through Tenth Targets Selection | ||||||
Collaboration arrangements | ||||||
Maximum target designation payments to which entitled per agreement | 16,500 | |||||
License revenue | Bristol Myers Squibb | Other Selected Targets | ||||||
Collaboration arrangements | ||||||
Milestone payments to be received upon achievement | $ 217,000 | |||||
Before Topic 606 | ||||||
Collaboration arrangements | ||||||
Revenue | 4,200 | |||||
Acquired research & development | ||||||
Collaboration arrangements | ||||||
Impairment recorded within R&D | 5,400 | |||||
Acquired research & development | BMS arrangement | Bristol Myers Squibb | ||||||
Collaboration arrangements | ||||||
Impairment recorded within R&D | $ 5,400 |
Collaboration arrangements an_4
Collaboration arrangements and concentration of credit risk - Amounts owed by BMS (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Number of ordinary shares held | 43,711,954 | 37,351,653 | |
Amounts owed in relation to the collaboration services | $ 947 | $ 233 | |
Total revenues | $ 7,281 | 11,284 | $ 13,107 |
Bristol Myers Squibb | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Minority interest | 5.50% | ||
Bristol Myers Squibb | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Number of ordinary shares held | 2,400,000 | ||
Before Topic 606 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Total revenues | 4,200 | ||
BMS arrangement | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Amounts owed in relation to the collaboration services | $ 947 | 233 | |
Total revenues | 7,281 | 11,284 | 13,107 |
BMS arrangement | Bristol Myers Squibb | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Amounts owed in relation to the collaboration services | 947 | 233 | |
Total revenues | 7,281 | 11,284 | 8,461 |
BMS arrangement | Chiesi Pharmaceutical | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Total revenues | $ 0 | $ 0 | $ 4,646 |
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 ($) | Jun. 30, 2013USD ($) | Jun. 30, 2013EUR (€) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Collaboration arrangements | ||||||
Revenue | $ 7,281 | $ 11,284 | $ 13,107 | |||
Percentage of costs to be paid by counterparty | 50.00% | |||||
BMS arrangement | ||||||
Collaboration arrangements | ||||||
Revenue | $ 7,281 | 11,284 | 13,107 | |||
BMS arrangement | Chiesi Pharmaceutical | ||||||
Collaboration arrangements | ||||||
Revenue | 0 | 0 | 4,646 | |||
License revenue | Chiesi Pharmaceutical | ||||||
Collaboration arrangements | ||||||
Up-front payment received | $ 22,100 | € 17 | ||||
Revenue | 0 | $ 0 | $ 0 | |||
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 |
Fair value measurement - Change
Fair value measurement - Changes in Level 3 items (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Changes in Level 3 liabilities | |||
Beginning Balance | $ 1,375 | $ 5,599 | $ 1,900 |
Exercises of convertible loan warrants | (631) | ||
Net losses recognized in profit or loss | 2,530 | (4,054) | 5,194 |
Contingent consideration paid | (1,181) | ||
Exercise of warrants | (770) | ||
Currency translation effects | (60) | (170) | (317) |
Ending Balance | 3,075 | 1,375 | 5,599 |
Contingent consideration | |||
Changes in Level 3 liabilities | |||
Beginning Balance | 3,964 | 1,838 | |
Net losses recognized in profit or loss | (3,846) | 3,002 | |
Contingent consideration paid | (1,181) | ||
Currency translation effects | (118) | (305) | |
Ending Balance | 3,964 | ||
Derivative financial instruments | |||
Changes in Level 3 liabilities | |||
Beginning Balance | 1,375 | 1,635 | 62 |
Exercises of convertible loan warrants | (631) | ||
Net losses recognized in profit or loss | 2,530 | (208) | 2,192 |
Exercise of warrants | (770) | ||
Currency translation effects | (60) | (52) | (12) |
Ending Balance | $ 3,075 | $ 1,375 | $ 1,635 |
Fair value measurement - BMS wa
Fair value measurement - BMS warrants - Narrative (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
May 31, 2015item | Dec. 31, 2019USD ($)item$ / shares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($)$ / shares | Dec. 31, 2017€ / shares | Dec. 31, 2016USD ($) | Apr. 06, 2015$ / shares | |
Collaboration arrangements | |||||||
Number of warrant types | 2 | ||||||
Fair value of derivative financial instruments | $ | $ 3,075 | $ 1,375 | $ 5,599 | $ 1,900 | |||
Exercise price in respect of each warrant | (per share) | $ 12 | € 10.10 | |||||
BMS Warrants | |||||||
Collaboration arrangements | |||||||
Exercise price in respect of each warrant | $ / shares | $ 52.39 | $ 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 | 82.50% | ||||||
BMS Warrants | Recurring | |||||||
Collaboration arrangements | |||||||
Derivative Asset | $ | $ 3,100 | $ 800 | |||||
BMS arrangement | Bristol Myers Squibb | |||||||
Collaboration arrangements | |||||||
Number of Collaboration Targets | 4 | 4 | |||||
BMS arrangement | Bristol Myers Squibb | Maximum | |||||||
Collaboration arrangements | |||||||
Number of Collaboration Targets | 10 | ||||||
Bristol Myers Squibb | uniQure N.V. | BMS Warrants | |||||||
Collaboration arrangements | |||||||
Number of Collaboration Targets actually are designated | 4 | ||||||
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 Six New Targets Or Designation Of Sixth Target | Minimum | |||||||
Collaboration arrangements | |||||||
Number of Collaboration Targets | 6 | ||||||
Bristol Myers Squibb | uniQure N.V. | BMS Warrants | First Six New Targets Or Designation Of Sixth Target | Maximum | |||||||
Collaboration arrangements | |||||||
Number of Collaboration Targets | 7 | ||||||
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% | ||||||
Bristol Myers Squibb | uniQure N.V. | BMS Warrants | First Nine New Targets Or Designation Of Ninth Target | Minimum | |||||||
Collaboration arrangements | |||||||
Number of Collaboration Targets | 9 | ||||||
Bristol Myers Squibb | uniQure N.V. | BMS Warrants | First Nine New Targets Or Designation Of Ninth Target | Maximum | |||||||
Collaboration arrangements | |||||||
Number of Collaboration Targets | 10 |
Fair value measurement - Sensit
Fair value measurement - Sensitivity analysis on warrants (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
BMS Warrants | |||
Fair value measurements | |||
Increase in volatility rate | 10.00% | ||
Volatility rate | 82.50% | ||
Level 3 | BMS Warrants | Other nonoperating income (expense) | |||
Fair value measurements | |||
Gain (Loss) recorded due to changes in fair value of derivative asset | $ 2,300 | $ 500 | $ 1,200 |
Level 3 | Recurring | Maximum | |||
Fair value measurements | |||
Expected exercise period | 4 years | ||
Level 3 | Recurring | Minimum | |||
Fair value measurements | |||
Expected exercise period | 2 years | ||
Level 3 | Recurring | BMS Warrants | |||
Fair value measurements | |||
Base case | $ 3,075 | ||
Increase volatility by 10% to 82.5% | 680 | ||
Extend exercise dates by one year | $ (31) |
Fair value measurement - Hercul
Fair value measurement - Hercules loan facility and Contingent consideration (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 01, 2019 | Oct. 02, 2017 | Aug. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2014 | Sep. 13, 2019 | Sep. 10, 2019 | May 07, 2018 | Oct. 27, 2017 | Dec. 31, 2016 |
Fair value measurements | ||||||||||||
Issue price per share | $ 46 | $ 46 | $ 28.50 | $ 18.25 | ||||||||
Proceeds from exercise of warrants | $ 500 | |||||||||||
Net losses recognized in profit or loss | 2,530 | $ (4,054) | $ 5,194 | |||||||||
Contingent consideration | ||||||||||||
Fair value of contingent liability | 3,075 | 1,375 | 5,599 | $ 1,900 | ||||||||
Percentage of future milestones that can be settled with ordinary shares, reduced rate | 50.00% | |||||||||||
Number of shares issued | 64,648 | |||||||||||
Percentage of future milestones that can be settled with ordinary shares | 100.00% | |||||||||||
Increase in fair value of the contingent consideration | 2,300 | |||||||||||
Restricted share units ("RSUs") | ||||||||||||
Contingent consideration | ||||||||||||
Up-front payment received | $ 1,200 | |||||||||||
Percentage of future milestones that can be settled with ordinary shares, reduced rate | 50.00% | |||||||||||
Recurring | Level 3 | Hercules Loan Facility Warrant | ||||||||||||
Fair value measurements | ||||||||||||
Fair value of derivative liability | 0 | 600 | ||||||||||
Recurring | Level 3 | Hercules Loan Facility Warrant | Other nonoperating income (expense) | ||||||||||||
Fair value measurements | ||||||||||||
Net losses recognized in profit or loss | (200) | (300) | $ (300) | |||||||||
Bristol Myers Squibb | BMS arrangement | Hercules Warrants | ||||||||||||
Fair value measurements | ||||||||||||
Number of shares issued for exercise of warrants | 37,175 | |||||||||||
Issue price per share | $ 34.25 | |||||||||||
Proceeds from exercise of warrants | $ 500 | |||||||||||
Contingent consideration | ||||||||||||
Fair value measurements | ||||||||||||
Net losses recognized in profit or loss | (3,846) | 3,002 | ||||||||||
Contingent consideration | ||||||||||||
Fair value of contingent liability | $ 3,964 | $ 1,838 | ||||||||||
InoCard | ||||||||||||
Contingent consideration | ||||||||||||
Number of shares issued | 64,648 | |||||||||||
InoCard | Contingent consideration | ||||||||||||
Contingent consideration | ||||||||||||
Change in contingent consideration | 3,800 | |||||||||||
Fair value of contingent liability | $ 0 | $ 0 |
Property, plant and equipment_3
Property, plant and equipment, net - Summary of PP&E (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property, plant and equipment, net | |||
Total property, plant, and equipment | $ 57,396 | $ 52,073 | |
Less accumulated depreciation | (28,625) | (22,894) | |
Property, plant and equipment, net | 28,771 | 29,179 | |
Depreciation | 6,000 | 6,500 | $ 7,000 |
Leasehold improvements | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | 34,611 | 32,462 | |
Laboratory equipment | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | 18,232 | 16,685 | |
Office equipment | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | 4,212 | 2,853 | |
Construction-in-progress | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | $ 341 | $ 73 |
Property, plant and equipment_4
Property, plant and equipment, net - PP&E by geographic region (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Long-lived assets | ||
Long-lived assets | $ 28,771 | $ 29,179 |
Lexington | ||
Long-lived assets | ||
Long-lived assets | 15,490 | 14,598 |
Amsterdam | ||
Long-lived assets | ||
Long-lived assets | $ 13,281 | $ 14,581 |
Right-of-use asset and lease _3
Right-of-use asset and lease liabilities - Narrative (Details) € in Millions, $ in Millions | 1 Months Ended | 12 Months Ended | ||||||||
Nov. 30, 2018ft²item | May 31, 2017facility | Dec. 31, 2019USD ($) | Dec. 31, 2019EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 01, 2017 | Jun. 30, 2016 | Mar. 31, 2016 | Nov. 30, 2013 | |
Leases | ||||||||||
Area of facility (in square feet) | ft² | 30,655 | |||||||||
Lease incentives | $ | $ 12.2 | $ 12.2 | ||||||||
Weighted-average remaining lease term, Operating leases | 10 years 3 months 18 days | 10 years 3 months 18 days | ||||||||
Weighted-average discount rate, Operating leases | 11.33% | 11.33% | ||||||||
Lexington | ||||||||||
Leases | ||||||||||
Lease term (in years) | 5 years | 10 years | ||||||||
Number of subsequent renewals | item | 2 | |||||||||
Renewal term (in years) | 5 years | |||||||||
Amsterdam | ||||||||||
Leases | ||||||||||
Lease term (in years) | 8 years | 8 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 | $ 8.9 | € 7.9 |
Right-of-use asset and lease _4
Right-of-use asset and lease liabilities - Operating lease liabilities (Details) $ in Thousands | 12 Months Ended | ||||||
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2019 | Dec. 31, 2019$ / € | Jan. 01, 2019USD ($) | |
Components of lease cost | |||||||
Operating lease cost | $ 4,474 | ||||||
Variable lease cost | 507 | ||||||
Sublease income | (1,053) | ||||||
Total lease cost | $ 3,928 | ||||||
Operating Leases, Rent Expense, Net | $ 3,250 | $ 3,606 | |||||
Assets | |||||||
Operating lease right-of-use assets | $ 26,797 | ||||||
Current liabilities | |||||||
Current operating lease liability | 5,865 | ||||||
Non-current liabilities | |||||||
Non-current operating lease liability | 31,133 | ||||||
Total lease liabilities | 36,998 | ||||||
Weighted-average remaining lease term, Operating leases | 10 years 3 months 18 days | ||||||
Weighted-average discount rate, Operating leases | 11.33% | ||||||
Supplemental cash flow information related to leases | |||||||
Cash paid for amounts included in the measurement of lease liabilities, Operating cash flows for operating leases | $ 4,717 | ||||||
Right-of-use asset obtained in exchange for lease obligation | |||||||
Operating lease | 9,002 | ||||||
Landlord incentive payments | 1,500 | ||||||
Amount capitalized of right-of-use assets | $ 19,000 | ||||||
Undiscounted Cash Flows | |||||||
2020 | 5,866 | ||||||
2021 | 5,488 | ||||||
2022 | 5,444 | ||||||
2023 | 5,542 | ||||||
2024 | 6,038 | ||||||
Thereafter | 33,829 | ||||||
Total minimum lease payments | 62,207 | ||||||
Less: amount of lease payments representing interest | (25,209) | ||||||
Total lease liabilities | 36,998 | ||||||
Less: current obligations under operating leases | (5,865) | ||||||
Non-current operating lease liability | 31,133 | ||||||
Exchange rate (in USD per Euro) | 1.12 | 1.12 | |||||
ASU 2016-02 | |||||||
Assets | |||||||
Operating lease right-of-use assets | $ 19,000 | ||||||
Non-current liabilities | |||||||
Total lease liabilities | 28,100 | ||||||
Undiscounted Cash Flows | |||||||
2019 | 4,670 | ||||||
2020 | 5,330 | ||||||
2021 | 5,425 | ||||||
2022 | 5,522 | ||||||
2023 | 5,620 | ||||||
Thereafter | 40,977 | ||||||
Total minimum lease payments | 67,544 | ||||||
Total lease liabilities | $ 28,100 | ||||||
Lexington | |||||||
Components of lease cost | |||||||
Operating Leases, Rent Expense, Net | 1,583 | 1,103 | |||||
Current liabilities | |||||||
Current operating lease liability | 3,360 | ||||||
Non-current liabilities | |||||||
Non-current operating lease liability | 20,534 | ||||||
Total lease liabilities | 23,894 | ||||||
Undiscounted Cash Flows | |||||||
2020 | 3,360 | ||||||
2021 | 3,455 | ||||||
2022 | 3,552 | ||||||
2023 | 3,650 | ||||||
2024 | 4,146 | ||||||
Thereafter | 20,745 | ||||||
Total minimum lease payments | 38,908 | ||||||
Less: amount of lease payments representing interest | (15,014) | ||||||
Total lease liabilities | 23,894 | ||||||
Less: current obligations under operating leases | (3,360) | ||||||
Non-current operating lease liability | 20,534 | ||||||
Lexington | ASU 2016-02 | |||||||
Undiscounted Cash Flows | |||||||
2019 | 2,707 | ||||||
2020 | 3,360 | ||||||
2021 | 3,455 | ||||||
2022 | 3,552 | ||||||
2023 | 3,650 | ||||||
Thereafter | 24,892 | ||||||
Total minimum lease payments | 41,616 | ||||||
Amsterdam | |||||||
Components of lease cost | |||||||
Operating Leases, Rent Expense, Net | 1,667 | $ 2,503 | |||||
Current liabilities | |||||||
Current operating lease liability | 2,364 | ||||||
Non-current liabilities | |||||||
Non-current operating lease liability | 10,475 | ||||||
Total lease liabilities | 12,839 | ||||||
Undiscounted Cash Flows | |||||||
2020 | 2,365 | ||||||
2021 | 1,892 | ||||||
2022 | 1,892 | ||||||
2023 | 1,892 | ||||||
2024 | 1,892 | ||||||
Thereafter | 13,084 | ||||||
Total minimum lease payments | 23,017 | ||||||
Less: amount of lease payments representing interest | (10,178) | ||||||
Total lease liabilities | 12,839 | ||||||
Less: current obligations under operating leases | (2,364) | ||||||
Non-current operating lease liability | 10,475 | ||||||
Amsterdam | ASU 2016-02 | |||||||
Undiscounted Cash Flows | |||||||
2019 | 1,963 | ||||||
2020 | 1,970 | ||||||
2021 | 1,970 | ||||||
2022 | 1,970 | ||||||
2023 | 1,970 | ||||||
Thereafter | 16,085 | ||||||
Total minimum lease payments | $ 25,926 | ||||||
Other | |||||||
Current liabilities | |||||||
Current operating lease liability | 141 | ||||||
Non-current liabilities | |||||||
Non-current operating lease liability | 124 | ||||||
Total lease liabilities | 265 | ||||||
Undiscounted Cash Flows | |||||||
2020 | 141 | ||||||
2021 | 141 | ||||||
Total minimum lease payments | 282 | ||||||
Less: amount of lease payments representing interest | (17) | ||||||
Total lease liabilities | 265 | ||||||
Less: current obligations under operating leases | (141) | ||||||
Non-current operating lease liability | $ 124 |
Intangible assets - Summary of
Intangible assets - Summary of acquired licenses (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Intangible assets | ||
Intangible assets, net | $ 5,427 | $ 5,201 |
Weighted average remaining life | 10 years 8 months 12 days | |
Capitalized expenditures related to milestone payments | $ 1,000 | 1,900 |
Licenses | ||
Intangible assets | ||
Total intangible assets | 8,317 | 7,528 |
Less accumulated amortization | (2,890) | (2,327) |
Intangible assets, net | $ 5,427 | 5,201 |
Acquired research & development | ||
Intangible assets | ||
Intangible assets, net | $ 0 |
Intangible assets - Future amor
Intangible assets - Future amortization expense (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Estimated amortization expense for the next five years | ||
Intangible assets, net | $ 5,427 | $ 5,201 |
Licenses | ||
Estimated amortization expense for the next five years | ||
2020 | 582 | |
2021 | 573 | |
2022 | 545 | |
2023 | 545 | |
2024 | 515 | |
Thereafter | 2,667 | |
Intangible assets, net | $ 5,427 | $ 5,201 |
Intangible assets - Carrying am
Intangible assets - Carrying amount of Licenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Intangible assets | |||
Carrying amount | $ 5,427 | $ 5,201 | |
Licenses | |||
Intangible assets | |||
Carrying amount | $ 5,427 | 5,201 | |
Amortization period (in years) | 20 years | ||
Licenses | Research and development expenses | |||
Intangible assets | |||
Amortization of Intangible Assets | $ 600 | 400 | $ 1,000 |
Licenses | Protein Sciences Corporation | |||
Intangible assets | |||
Carrying amount | 1,911 | 2,084 | |
Licenses | St. Jude Children's Hospital | |||
Intangible assets | |||
Carrying amount | 1,404 | 633 | |
Licenses | Other | |||
Intangible assets | |||
Carrying amount | $ 2,112 | 2,484 | |
Acquired research & development | |||
Intangible assets | |||
Carrying amount | 0 | ||
Impairment recorded within R&D | $ 5,400 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued expenses and other current liabilities | ||
Accruals for services provided by vendors-not yet billed | $ 5,425 | $ 1,999 |
Personnel related accruals and liabilities | 7,032 | 5,688 |
Derivative financial liability warrants (see note 4) | 545 | |
Total | $ 12,457 | $ 8,232 |
Long-term debt (Details)
Long-term debt (Details) - USD ($) $ in Thousands | Dec. 06, 2018 | May 06, 2016 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Long-term Debt | ||||||
Maximum borrowing capacity | $ 50,000 | |||||
Proceeds from loan increment | $ 14,775 | |||||
Aggregate maturities of loan | ||||||
Coupon interest payments and financing fees | 11,500 | |||||
2020 | 4,119 | |||||
2021 | 3,141 | |||||
2022 | 25,002 | |||||
2023 | 14,269 | |||||
Total | $ 46,531 | |||||
2016 Amended Facility | Hercules | ||||||
Long-term Debt | ||||||
Interest rate (as a percent) | 8.25% | 8.25% | ||||
2016 Amended Facility | Hercules | Second Amended and Restated Loan and Security Agreement [Member] | ||||||
Long-term Debt | ||||||
Outstanding debt | $ 20,000 | |||||
Back-end fee (as a percent) | 4.85% | |||||
2016 Amended Facility | Prime Rate | Hercules | ||||||
Long-term Debt | ||||||
Variable interest rate basis | 8.25% | 8.25% | ||||
2018 Amended Facility | Hercules | ||||||
Long-term Debt | ||||||
Aggregate amount of Equity Financing | $ 90,000 | |||||
Foreign currency gain | 700 | 900 | $ 2,600 | |||
2018 Amended Facility | Hercules | Second Amended and Restated Loan and Security Agreement [Member] | ||||||
Long-term Debt | ||||||
Outstanding debt | $ 35,000 | $ 35,000 | ||||
Proceed from drew down | $ 15,000 | |||||
Interest rate (as a percent) | 8.85% | 8.85% | ||||
Back-end fee (as a percent) | 4.95% | |||||
Maximum borrowing capacity | $ 30,000 | |||||
Borrowing capacity subject to discretion | 15,000 | |||||
Amount the company has right to draw | $ 15,000 | |||||
Facility fee (as a percent) | 0.50% | 0.50% | ||||
2018 Amended Facility | Prime Rate | Hercules | Second Amended and Restated Loan and Security Agreement [Member] | ||||||
Long-term Debt | ||||||
Variable interest rate basis | 8.85% | 8.85% | ||||
Discount rate (as a percent) | 5.50% | 5.50% | ||||
Venture debt loan facility | ||||||
Long-term Debt | ||||||
Outstanding debt | 20,000 | $ 20,000 | ||||
Venture debt loan facility | 2016 Amended Facility | Prime Rate | Hercules | ||||||
Long-term Debt | ||||||
Discount rate (as a percent) | 5.25% | |||||
Venture debt loan facility | 2018 Amended Facility | ||||||
Long-term Debt | ||||||
Amortized cost net of discount and debt issuance costs | $ 36,300 | 35,700 | ||||
Minimum cash and cash equivalents in U.S. bank accounts | 65.00% | |||||
Venture debt loan facility | 2018 Amended Facility | Hercules | ||||||
Long-term Debt | ||||||
Interest expense recorded | $ 3,700 | $ 2,000 | $ 2,200 |
Shareholders' equity (Details)
Shareholders' equity (Details) € / shares in Units, $ / shares in Units, $ in Thousands, € in Millions | Sep. 13, 2019USD ($)$ / sharesshares | Sep. 10, 2019$ / sharesshares | Feb. 01, 2019USD ($)$ / sharesshares | May 07, 2018USD ($)$ / sharesshares | May 02, 2018shares | Oct. 27, 2017USD ($)$ / sharesshares | Oct. 02, 2017USD ($)shares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)$ / shares | Dec. 31, 2019USD ($) | Dec. 31, 2019$ / € | Dec. 31, 2019€ / shares | Dec. 31, 2019EUR (€) | Dec. 31, 2019shares | Dec. 31, 2018€ / shares | Dec. 31, 2017€ / shares |
Authorized share capital | $ 3,400 | € 3 | ||||||||||||||||
Exchange rate (in USD per Euro) | 1.12 | 1.12 | ||||||||||||||||
Shares authorized | shares | 60,000,000 | 60,000,000 | ||||||||||||||||
Ordinary shares, par value (in euros per share) | € / shares | € 0.05 | € 0.05 | ||||||||||||||||
Reserves for foreign currency translation effects | $ | $ 3,800 | $ 7,300 | $ 3,800 | $ 6,700 | ||||||||||||||
Shares issued in connection with offering | shares | 733,695 | 4,891,305 | 5,175,000 | 5,000,000 | ||||||||||||||
Offering price per share of shares issued | $ / shares | $ 46 | $ 46 | $ 28.50 | $ 18.25 | ||||||||||||||
Gross Proceeds From Issuance Initial Public Offering | $ | $ 258,800 | $ 147,500 | $ 91,300 | |||||||||||||||
Proceeds from issuance initial public offering | $ | $ 242,718 | $ 138,361 | $ 85,290 | |||||||||||||||
Net proceeds from issuance of common stock | $ | 242,700 | 85,300 | ||||||||||||||||
Expenses capitalized related to offering | $ | $ 600 | $ 200 | $ 500 | |||||||||||||||
Proceeds from exercise of warrants | $ | $ 500 | |||||||||||||||||
Shares authorized under offering program | shares | 5,000,000 | |||||||||||||||||
Restricted share units distributed during the period (in shares) | shares | 114,172 | |||||||||||||||||
Warrants converted | shares | 128,710 | |||||||||||||||||
Warrants exercise price | (per share) | $ 12 | $ 12 | € 10.10 | |||||||||||||||
Number of shares issued | shares | 64,648 | |||||||||||||||||
InoCard | ||||||||||||||||||
Number of shares issued | shares | 64,648 | |||||||||||||||||
Cash consideration paid | $ | $ 0 | |||||||||||||||||
Hercules Warrants | BMS arrangement | Bristol Myers Squibb | ||||||||||||||||||
Offering price per share of shares issued | $ / shares | $ 34.25 | |||||||||||||||||
Number of shares issued for exercise of warrants | shares | 37,175 | |||||||||||||||||
Proceeds from exercise of warrants | $ | $ 500 |
Share-based compensation - Summ
Share-based compensation - Summary of share-based compensation expense and unrecognized costs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based compensation | |||
Share-based compensation expense | $ 17,468 | $ 10,693 | $ 10,280 |
Unrecognized compensation costs | $ 32,496 | ||
Weighted-average remaining period for recognition (in years) | 2 years 5 months 26 days | ||
2014 Plan | |||
Share-based compensation | |||
Authorized shares | 8,601,471 | 3,000,000 | |
Outstanding of fully vested share options | 2,683,104 | 2,673,712 | |
Research and development expenses | Employees | |||
Share-based compensation | |||
Share-based compensation expense | $ 8,029 | $ 3,994 | 3,945 |
Selling, general and administrative expense | Employees | |||
Share-based compensation | |||
Share-based compensation expense | 9,439 | 6,699 | 6,335 |
Share options | |||
Share-based compensation | |||
Share-based compensation expense | 7,896 | 4,766 | 3,246 |
Unrecognized compensation costs | $ 19,750 | ||
Weighted-average remaining period for recognition (in years) | 2 years 10 months 24 days | ||
Restricted share units ("RSUs") | |||
Share-based compensation | |||
Share-based compensation expense | $ 4,117 | 3,020 | 2,588 |
Unrecognized compensation costs | $ 7,035 | ||
Weighted-average remaining period for recognition (in years) | 1 year 10 months 24 days | ||
Performance share units ("PSUs") | |||
Share-based compensation | |||
Share-based compensation expense | $ 5,455 | $ 2,907 | $ 4,446 |
Unrecognized compensation costs | $ 5,711 | ||
Weighted-average remaining period for recognition (in years) | 1 year 9 months 10 days |
Share-based compensation - Opti
Share-based compensation - Option activity and weighted-average assumptions (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 24, 2018 | Sep. 20, 2017 | Jun. 30, 2018 | Dec. 31, 2019 | 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 terms (in years) | 10 years | 10 years | 10 years | |||||
Risk free interest rate, minimum (as a percent) | 1.92% | 2.67% | 2.39% | |||||
Risk free interest rate, maximum (as a percent) | 2.87% | 3.20% | 2.81% | |||||
Expected dividend (as a percent) | 0.00% | 0.00% | 0.00% | |||||
Minimum | ||||||||
Weighted-average assumptions used to estimate fair value of share options granted during year | ||||||||
Expected volatility (as a percent) | 70.00% | 75.00% | 75.00% | |||||
Maximum | ||||||||
Weighted-average assumptions used to estimate fair value of share options granted during year | ||||||||
Expected volatility (as a percent) | 75.00% | 80.00% | 80.00% | |||||
Share options | ||||||||
Weighted average remaining contractual life (in years) | ||||||||
Exercised (in dollars) | $ 17,700 | $ 7,515 | $ 1,291 | |||||
Aggregate intrinsic value | ||||||||
Exercised (in dollars) | $ 17,700 | $ 7,515 | $ 1,291 | |||||
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 | ||||||
2014 Plan | ||||||||
Options | ||||||||
Outstanding at beginning of year (in shares) | 2,673,712 | |||||||
Granted (in shares) | 647,526 | |||||||
Forfeited (in shares) | (202,926) | |||||||
Expired (in shares) | (543) | |||||||
Exercised (in shares) | (434,665) | (388,203) | (198,552) | |||||
Outstanding at end of year (in shares) | 2,683,104 | 2,673,712 | ||||||
Thereof, fully vested and exercisable at end of year (in shares) | 1,336,767 | |||||||
Outstanding and expected to vest at end of year (in shares) | 1,346,337 | 1,599,797 | ||||||
Weighted average exercise price | ||||||||
Outstanding at beginning of year (in dollars per share) | $ 15.09 | |||||||
Granted (in dollars per share) | 40.31 | |||||||
Forfeited (in dollars per share) | 20.09 | |||||||
Expired (in dollars per share) | 12.26 | |||||||
Exercised (in dollars per share) | 11.91 | |||||||
Outstanding at end of year (in dollars per share) | 21.29 | $ 15.09 | ||||||
Thereof, fully vested and exercisable at end of year (in dollars per share) | 13.76 | |||||||
Outstanding and expected to vest at end of year (in dollars per share) | $ 28.76 | $ 17.96 | ||||||
Total weighted average grant date fair value of options issued during the period (in $ millions) | $ 15,300 | |||||||
Proceeds from option sales | $ 5,200 | |||||||
Vesting period (in years) | 4 years | |||||||
Weighted-average assumptions used to estimate fair value of share options granted during year | ||||||||
Increase in authorized shares | 3,000,000 | 1,070,000 | ||||||
Weighted average remaining contractual life (in years) | ||||||||
Outstanding | 7 years 5 months 15 days | 7 years 11 months 23 days | ||||||
Thereof, fully vested and exercisable at end of year | 6 years 7 months 13 days | |||||||
Outstanding and expected to vest at end of year | 8 years 3 months 14 days | |||||||
Aggregate intrinsic value | ||||||||
Outstanding (in dollars) | $ 135,238 | $ 39,616 | ||||||
Thereof, fully vested and exercisable | 77,394 | |||||||
Outstanding and expected to vest | $ 57,844 | |||||||
2014 Plan | Share options | ||||||||
Options | ||||||||
Granted (in shares) | 150,000 | 647,526 | 937,832 | 1,295,350 | ||||
Forfeited (in shares) | (202,926) | |||||||
Outstanding and expected to vest at end of year (in shares) | 1,346,337 | 1,599,797 | ||||||
Weighted average exercise price | ||||||||
Granted (in dollars per share) | $ 8.49 | |||||||
Outstanding and expected to vest at end of year (in dollars per share) | $ 17.05 | $ 10.83 | ||||||
Weighted average grant-date fair value | ||||||||
Vested (in shares) | 698,127 | |||||||
Vested (in dollar per share) | $ 10.38 | |||||||
Forfeited (in dollar per share) | $ 12.09 | |||||||
2014 Plan | Non-executive directors | ||||||||
Weighted average exercise price | ||||||||
Vesting period (in years) | 1 year | |||||||
2014 Plan | Directors and Officers | ||||||||
Options | ||||||||
Granted (in shares) | 223,097 | |||||||
Weighted average exercise price | ||||||||
Granted (in dollars per share) | $ 4.1 | |||||||
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 - RSU
Share-based compensation - RSU activity (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 24, 2018 | Jun. 30, 2018 | Mar. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
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) | 412,321 | |||||
Restricted stock granted (in shares) | 198,504 | |||||
Vested (in shares) | (205,583) | |||||
Forfeited (in shares) | (34,412) | |||||
Non-vested at end of year (in shares) | 370,830 | 412,321 | ||||
Weighted average grant-date fair value | ||||||
Non-vested at beginning of year (in dollars per share) | $ 16.49 | |||||
Granted (in dollars per share) | 38.63 | |||||
Vested (in dollars per share) | 15.31 | |||||
Forfeited (in dollars per share) | 20.62 | |||||
Non-vested at end of year (in dollars per share) | $ 28.62 | $ 16.49 | ||||
Other disclosure | ||||||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 7,700 | |||||
Restricted share units ("RSUs") | Non-executive directors | ||||||
Other disclosure | ||||||
Vesting period (in years) | 1 year | |||||
Restricted share units ("RSUs") | Directors and Officers | ||||||
Number of shares | ||||||
Restricted stock granted (in shares) | 109,349 | |||||
Weighted average grant-date fair value | ||||||
Granted (in dollars per share) | $ 4 | |||||
Restricted share units ("RSUs") | 2014 Plan | ||||||
Number of shares | ||||||
Restricted stock granted (in shares) | 198,504 | 262,599 | 603,350 | |||
Weighted average grant-date fair value | ||||||
Granted (in dollars per share) | $ 38.63 | $ 23.61 | $ 5.86 | |||
Other disclosure | ||||||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 10,152 | $ 8,546 | $ 2,917 | |||
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) | $ 23.57 | $ 15.90 | $ 3.87 | |||
Minimum | Restricted share units ("RSUs") | ||||||
Other disclosure | ||||||
Vesting period (in years) | 1 year | |||||
Maximum | Restricted share units ("RSUs") | ||||||
Other disclosure | ||||||
Vesting period (in years) | 3 years |
Share-based compensation - PSU
Share-based compensation - PSU activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Performance share units ("PSUs") | |||
Number of shares | |||
Non-vested at beginning of year (in shares) | 377,169 | ||
Restricted stock granted (in shares) | 132,362 | ||
Forfeited (in shares) | (30,109) | ||
Non-vested at end of year (in shares) | 479,422 | 377,169 | |
PSUs awarded but not yet earned | 83,489 | ||
Total non-vested and discretionary PSUs | 562,911 | ||
Weighted average grant-date fair value | |||
Non-vested at beginning of year (in dollars per share) | $ 16.73 | ||
Granted (in dollars per share) | 31.71 | ||
Forfeited (in dollars per share) | 11.83 | ||
Non-vested at end of year (in dollars per share) | 21.17 | $ 16.73 | |
PSUs awarded but not yet earned (in dollars per share) | 71.66 | ||
Total non-vested and discretionary PSUs (in dollars per share) | $ 28.66 | ||
Other disclosure | |||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 10,200 | ||
Performance share units ("PSUs") | 2014 Plan | |||
Number of shares | |||
Restricted stock granted (in shares) | 132,362 | 550,570 | |
Weighted average grant-date fair value | |||
Granted (in dollars per share) | $ 31.71 | $ 17.15 | |
Other disclosure | |||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 1,056 | $ 1,350 | $ 1,730 |
Share options | 2014 Plan | |||
Weighted average grant-date fair value | |||
Granted (in dollars per share) | $ 23.57 | $ 15.90 | $ 3.87 |
Share-based compensation - Empl
Share-based compensation - Employee Share Purchase Plan - Narrative (Details) - shares | Oct. 02, 2017 | Jun. 30, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Share-based compensation | ||||
Number of shares issued | 64,648 | |||
ESPP | Employee Stock [Member] | ||||
Share-based compensation | ||||
Ordinary shares available for issue | 150,000 | 138,207 | ||
Discounted rate for purchase of shares | 85.00% | |||
Number of shares issued | 9,202 | 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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share options | |||
Weighted average remaining contractual life (in years) | |||
Exercised (in dollars) | $ 17,700 | $ 7,515 | $ 1,291 |
Aggregate intrinsic value | |||
Exercised (in dollars) | $ 17,700 | $ 7,515 | $ 1,291 |
2012 Plan | |||
Options | |||
Outstanding at beginning of year (in shares) | 32,567 | ||
Exercised (in shares) | (18,567) | ||
Outstanding at end of year (in shares) | 14,000 | 32,567 | |
Weighted average exercise price | |||
Outstanding at beginning of year (in dollars per share) | $ 5.23 | ||
Exercised (in dollars per share) | 3.07 | ||
Outstanding at end of year (in dollars per share) | $ 8.09 | $ 5.23 | |
Proceeds from option sales | $ 100 | ||
Weighted average remaining contractual life (in years) | |||
Outstanding | 3 years 1 month 6 days | 3 years 7 months 13 days | |
Aggregate intrinsic value | |||
Outstanding (in dollars) | $ 876 | $ 939 | |
2012 Plan | Share options | |||
Options | |||
Exercised (in shares) | (18,567) | (40,251) | (405,188) |
Weighted average remaining contractual life (in years) | |||
Exercised (in dollars) | $ 1,014 | $ 964 | $ 1,176 |
Aggregate intrinsic value | |||
Exercised (in dollars) | $ 1,014 | $ 964 | $ 1,176 |
Expenses by nature - Operating
Expenses by nature - Operating expenses excluding expenses presented in other expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating expenses: | |||
Employee-related expenses | $ 59,130 | $ 46,254 | $ 46,373 |
Laboratory and development expenses | 30,130 | 23,596 | 17,737 |
Office and housing expenses | 10,588 | 7,281 | 9,327 |
Legal and advisory expenses | 11,297 | 7,748 | 8,121 |
Depreciation, amortization and impairment expenses | 6,669 | 12,415 | 6,779 |
Patent and license expenses | 1,654 | 1,202 | 817 |
Other operating expenses | 8,813 | 1,618 | 7,653 |
Total | $ 128,281 | $ 100,114 | $ 96,807 |
Expenses by nature - Employee-r
Expenses by nature - Employee-related expenses (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019USD ($)employee | Dec. 31, 2018USD ($)employee | Dec. 31, 2017USD ($)employee | |
Employee-related expenses | |||
Wages and salaries | $ 32,029 | $ 26,646 | $ 25,131 |
Share-based compensation expenses | 17,533 | 10,708 | 10,280 |
Consultant expenses | 2,464 | 2,974 | 4,758 |
Social security costs | 2,727 | 2,231 | 2,077 |
Health insurance | 1,933 | 1,750 | 1,536 |
Pension costs - defined contribution plans | 650 | 628 | 802 |
Other employee expenses | 1,794 | 1,317 | 1,789 |
Total | $ 59,130 | $ 46,254 | $ 46,373 |
Number of employees at the end of the period | employee | 248 | 212 | 202 |
Other non-operating income _ _3
Other non-operating income / (expense) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Other non-operating income | |||
Derivative gains | $ 208 | ||
Total other non-operating income: | 208 | ||
Other non-operating expense | |||
Derivative losses | $ (2,530) | $ (2,192) | |
Finance expenses | (243) | ||
Total other non-operating expense: | (2,530) | (2,435) | |
Other non-operating (expense) / income, net | (2,530) | 208 | (2,435) |
Gain (Loss) recorded due to changes in fair value of derivative liability | 2,530 | (4,054) | 5,194 |
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 | (200) | (300) | (300) |
Recurring | Level 3 | Hercules Loan Facility Warrant | Other nonoperating income (expense) | 2013 Convertible Loan | |||
Other non-operating expense | |||
Gain (Loss) recorded due to changes in fair value of derivative liability | 700 | ||
Bristol Myers Squibb | |||
Other non-operating income | |||
Derivative gains | $ 500 | ||
Other non-operating expense | |||
Derivative losses | $ (2,300) | $ (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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Loss before income taxes | |||
Dutch operations | $ (111,820) | $ (85,721) | $ (60,966) |
Loss before income tax expense | (124,201) | (83,073) | (79,459) |
Current tax (expense) / benefit | |||
Dutch operations | 0 | ||
Total current income tax (expense) / benefit | (22) | (10) | |
Deferred tax (expense) / benefit | |||
Dutch operations | (209) | 209 | |
Total deferred income tax (expense) / benefit | (209) | 209 | |
Income tax (expense) / benefit | (231) | 199 | |
U.S. operations | |||
Loss before income taxes | |||
Loss before income tax benefit / (expense) | (12,381) | 2,646 | (18,493) |
Current tax (expense) / benefit | |||
Current benefit / (expense) | $ 0 | ||
Foreign operations | |||
Loss before income taxes | |||
Loss before income tax benefit / (expense) | 3 | ||
Current tax (expense) / benefit | |||
Current benefit / (expense) | $ (22) | $ (10) |
Income taxes - Tax rate reconci
Income taxes - Tax rate reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Tax rate reconciliation | |||
Loss before income tax expense for the perio | $ (124,201) | $ (83,073) | $ (79,459) |
Expected income tax benefit / (expense) at the tax rate enacted in the Netherlands (25%) | 31,050 | 20,768 | 19,865 |
Difference in tax rates between the Netherlands and foreign countries | (495) | (106) | 1,664 |
Net change in valuation allowance | (25,583) | (19,207) | (17,358) |
Non deductible expenses | (4,972) | (2,648) | (3,248) |
Change in fair value of contingent consideration | 962 | (724) | |
Income tax (expense) / benefit | (231) | 199 | |
Non-deductible expenses, Share-based compensation | 4,400 | 2,700 | 2,500 |
Non-deductible expenses, Derivatives | $ 600 | $ 0 | $ 500 |
Income taxes - Significant comp
Income taxes - Significant components of deferred taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||||
Deferred tax asset attributable to carryforward losses | $ 99,644 | $ 74,529 | ||
Intangible assets | 770 | 847 | ||
Lease liabilities | 7,861 | |||
Property, plant and equipment | 761 | 561 | ||
Deferred revenue | 6,676 | 7,481 | ||
Accrued expenses and other current liabilities | 628 | 1,682 | ||
Gross deferred tax asset | 116,340 | 85,100 | ||
Less valuation allowance | (109,856) | (85,100) | $ (93,682) | $ (82,642) |
Net deferred tax asset | 6,484 | |||
Deferred tax liabilities: | ||||
Right-of-use asset | (6,484) | |||
Net deferred tax liability | (6,484) | |||
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Opening balance | $ 85,100 | $ 93,682 | $ 82,642 |
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 | 25,583 | 19,207 | 19,080 |
Reduction related to tax reform | 4,059 | (15,670) | |
Currency translation effects | (4,886) | (5,890) | (6,318) |
Ending balance | 109,856 | 85,100 | 93,682 |
Amount of valuation allowance for deferred tax assets within contributed capital as it relates to follow on offering costs. | $ 6,900 | $ 3,300 | |
U.S. operations | |||
Reduction related to 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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Net operating loss carryforwards utilization | $ 3.7 | $ 4.5 | $ 0 | |||
Reduction of gross deferred tax asset | $ 4.1 | $ (1.7) | ||||
Operating loss carryforwards period (in years) | 6 years | 9 years | ||||
Maximum | ||||||
U.S. corporate statutory income tax rate (as a percent) | 21.70% | |||||
Dutch tax reform | 25.00% | |||||
Minimum | ||||||
U.S. corporate statutory income tax rate (as a percent) | 20.50% | |||||
Dutch tax reform | 20.50% | |||||
Forecast | ||||||
U.S. corporate statutory income tax rate (as a percent) | 21.70% | |||||
Forecast | Maximum | ||||||
U.S. corporate statutory income tax rate (as a percent) | 25.00% | |||||
Forecast | Minimum | ||||||
U.S. corporate statutory income tax rate (as a percent) | 22.55% | |||||
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Tax loss carry-forwards | |||
Tax loss carry-forwards | $ 414,000 | $ 311,700 | $ 246,000 |
Unrecognized Tax Benefits | $ 0 | $ 0 | |
Maximum Utilization Percentage Of Taxable Income | 80.00% | ||
Maximum | |||
Tax loss carry-forwards | |||
Tax loss carry-forward expiration (in years) | 8 years | ||
Minimum | |||
Tax loss carry-forwards | |||
Tax loss carry-forward expiration (in years) | 6 years | ||
2018 | |||
Tax loss carry-forwards | |||
Loss expiring | $ 20,000 | ||
2019 | |||
Tax loss carry-forwards | |||
Loss expiring | $ 20,700 | ||
2020 | |||
Tax loss carry-forwards | |||
Loss expiring | 18,479 | ||
2021 | |||
Tax loss carry-forwards | |||
Loss expiring | 13,905 | ||
2022 | |||
Tax loss carry-forwards | |||
Loss expiring | 23,664 | ||
2023 | |||
Tax loss carry-forwards | |||
Loss expiring | 23,047 | ||
2020-2027 | |||
Tax loss carry-forwards | |||
Loss expiring | 334,859 | ||
U.S. operations | 2018 | |||
Tax loss carry-forwards | |||
Loss expiring | $ 55,100 | ||
U.S. operations | 2019 | |||
Tax loss carry-forwards | |||
Tax loss carry-forwards | $ 46,700 |
Basic and diluted earnings pe_3
Basic and diluted earnings per share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 12,440,841 | 12,108,956 | 10,561,163 |
BMS Warrants | |||
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 8,893,000 | 8,575,000 | 6,800,000 |
Stock options | 2014 Plan | |||
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 2,683,104 | 2,673,712 | 2,456,433 |
Stock options | 2012 Plan | |||
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 14,000 | 32,567 | 72,818 |
Stock options | ESPP | |||
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 485 | 1,012 | |
Non-vested and earned RSUs and PSUs | |||
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 850,252 | 789,490 | 1,194,737 |
Hercules Warrants | |||
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 37,175 | 37,175 |
Related party transaction (Deta
Related party transaction (Details) | Oct. 24, 2018USD ($)shares | Sep. 20, 2017$ / sharesshares | Aug. 07, 2017EUR (€) | Jun. 30, 2018shares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2018shares | Dec. 31, 2017shares |
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) | 647,526 | ||||||
Vesting period (in years) | 4 years | ||||||
Granted (in dollars per share) | $ / shares | $ 40.31 | ||||||
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 | 647,526 | 937,832 | 1,295,350 | |||
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 |