Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 23, 2023 | Jun. 30, 2022 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 001-36294 | ||
Entity Registrant Name | uniQure N.V. | ||
Entity Incorporation, State or Country Code | P7 | ||
Entity Tax Identification Number | 00-0000000 | ||
Entity Address, Address Line One | Paasheuvelweg 25 | ||
Entity Address, City or Town | Amsterdam | ||
Entity Address, Country | NL | ||
Entity Address, Postal Zip Code | 1105 BP | ||
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 | ||
ICFR Auditor Attestation Flag | true | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 870.2 | ||
Entity Common Stock, Shares Outstanding | 46,982,485 | ||
Auditor Name | KPMG Accountants N.V. | ||
Auditor Firm ID | 1012 | ||
Auditor Location | Amstelveen, The Netherlands | ||
Entity Central Index Key | 0001590560 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 228,012 | $ 556,256 |
Current investment securities | 124,831 | |
Accounts receivable and contract asset | 102,376 | 58,768 |
Inventories | 6,924 | |
Prepaid expenses | 11,817 | 10,540 |
Other current assets and receivables | 2,814 | 2,675 |
Total current assets | 476,774 | 628,239 |
Non-current assets | ||
Property, plant and equipment, net | 50,532 | 43,505 |
Non-current investment securities | 39,984 | |
Operating lease right-of-use assets | 32,726 | 25,573 |
Intangible assets, net | 58,778 | 62,686 |
Goodwill | 25,581 | 27,633 |
Deferred tax assets, net | 14,528 | 15,647 |
Other non-current assets | 6,061 | 5,897 |
Total non-current assets | 228,190 | 180,941 |
Total assets | 704,964 | 809,180 |
Current liabilities | ||
Accounts payable | 10,984 | 2,502 |
Accrued expenses and other current liabilities | 30,571 | 28,487 |
Current portion of contingent consideration | 25,982 | |
Current portion of operating lease liabilities | 8,382 | 5,774 |
Total current liabilities | 75,919 | 36,763 |
Non-current liabilities | ||
Long-term debt | 102,791 | 100,963 |
Operating lease liabilities, net of current portion | 31,719 | 28,987 |
Contingent consideration, net of current portion | 9,334 | 29,542 |
Deferred tax liability, net | 8,257 | 12,913 |
Other non-current liabilities | 935 | 4,236 |
Total non-current liabilities | 153,036 | 176,641 |
Total liabilities | 228,955 | 213,404 |
Commitments and contingencies | ||
Shareholders' equity | ||
Ordinary shares, €0.05 par value: 80,000,000 shares authorized as of December 31, 2022 and December 31, 2021 and 46,968,032 and 46,298,635 ordinary shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively | 2,838 | 2,802 |
Additional paid-in-capital | 1,113,393 | 1,076,972 |
Accumulated other comprehensive loss | (58,291) | (28,856) |
Accumulated deficit | (581,931) | (455,142) |
Total shareholders' equity | 476,009 | 595,776 |
Total liabilities and shareholders' equity | $ 704,964 | $ 809,180 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - € / shares | Dec. 31, 2022 | Dec. 31, 2021 |
CONSOLIDATED BALANCE SHEETS | ||
Ordinary shares, par value (in euros per share) | € 0.05 | € 0.05 |
Ordinary shares, authorized | 80,000,000 | 80,000,000 |
Ordinary shares, issued | 46,968,032 | 46,298,635 |
Ordinary shares, outstanding | 46,968,032 | 46,298,635 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Total revenues | $ 106,483 | $ 524,002 | $ 37,514 |
Operating expenses: | |||
Cost of license revenues | (1,254) | (24,976) | |
Cost of contract manufacturing revenues | (2,089) | ||
Research and development expenses | (197,591) | (143,548) | (122,400) |
Selling, general and administrative expenses | (55,059) | (56,290) | (42,580) |
Total operating expenses | (255,993) | (224,814) | (164,980) |
Other income | 7,171 | 12,306 | 3,342 |
Other expense | (820) | (876) | (1,302) |
(Loss) / income from operations | (143,159) | 310,618 | (125,426) |
Interest income | 609 | 162 | 938 |
Interest expense | (11,704) | (7,474) | (3,825) |
Foreign currency gains / (losses), net | 23,235 | 29,660 | (13,613) |
Other non-operating gains / (losses), net | 2,760 | (160) | 483 |
(Loss) / income before income tax benefit / (expense) | (128,259) | 332,806 | (141,443) |
Income tax benefit / (expense) | 1,470 | (3,217) | 16,419 |
Net (loss) / income | (126,789) | 329,589 | (125,024) |
Other comprehensive loss: | |||
Foreign currency translation adjustments | (29,435) | (38,763) | 16,596 |
Total comprehensive (loss) / gain | $ (156,224) | $ 290,826 | $ (108,428) |
Earnings per ordinary share - basic | |||
Basic net (loss) / income per ordinary share | $ (2.71) | $ 7.17 | $ (2.81) |
Earnings per ordinary share - diluted | |||
Diluted net (loss) / income per ordinary share | $ (2.71) | $ 7.04 | $ (2.81) |
Weighted average shares - basic | 46,735,045 | 45,986,467 | 44,466,365 |
Weighted average shares - diluted | 46,735,045 | 46,840,972 | 44,466,365 |
License revenues | |||
Total revenues | $ 100,000 | $ 517,400 | $ 4,352 |
License revenues from related parties | |||
Total revenues | 0 | 0 | 32,967 |
Contract manufacturing revenues | |||
Total revenues | 1,717 | ||
Collaboration revenues | |||
Total revenues | $ 4,766 | $ 6,602 | 59 |
Collaboration revenues from related parties | |||
Total revenues | $ 136 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Ordinary shares | Additional paid-in capital | Accumulated other comprehensive income / (loss) | Accumulated deficit | Total |
Beginning balance at Dec. 31, 2019 | $ 2,651 | $ 986,803 | $ (6,689) | $ (659,707) | $ 323,058 |
Beginning balance (in shares) at Dec. 31, 2019 | 43,711,954 | ||||
Increase (decrease) in shareholders' equity | |||||
Income / Loss for the period | (125,024) | (125,024) | |||
Other comprehensive Income / Loss | 16,596 | 16,596 | |||
Exercise of share options | $ 29 | 7,169 | 7,198 | ||
Exercise of share options (in shares) | 498,678 | ||||
Restricted and performance share units distributed during the period | $ 31 | (31) | |||
Restricted and performance share units distributed during the period (in shares) | 560,986 | ||||
Share-based compensation expense | 21,831 | 21,831 | |||
Issuance of ordinary shares relating to employee stock purchase plan | 246 | 246 | |||
Issuance of ordinary shares relating to employee stock purchase plan (in shares) | 6,181 | ||||
Ending balance at Dec. 31, 2020 | $ 2,711 | 1,016,018 | 9,907 | (784,731) | 243,905 |
Ending balance (in shares) at Dec. 31, 2020 | 44,777,799 | ||||
Increase (decrease) in shareholders' equity | |||||
Income / Loss for the period | 329,589 | 329,589 | |||
Other comprehensive Income / Loss | (38,763) | (38,763) | |||
Issuance of ordinary shares | $ 55 | 29,509 | 29,564 | ||
Issuance of ordinary shares (in shares) | 921,730 | ||||
Income tax benefit of past share issuance cost | 3,047 | 3,047 | |||
Exercise of share options | $ 15 | 2,638 | 2,653 | ||
Exercise of share options (in shares) | 241,496 | ||||
Restricted and performance share units distributed during the period | $ 21 | (21) | |||
Restricted and performance share units distributed during the period (in shares) | 352,886 | ||||
Share-based compensation expense | 25,635 | 25,635 | |||
Issuance of ordinary shares relating to employee stock purchase plan | 146 | 146 | |||
Issuance of ordinary shares relating to employee stock purchase plan (in shares) | 4,724 | ||||
Ending balance at Dec. 31, 2021 | $ 2,802 | 1,076,972 | (28,856) | (455,142) | $ 595,776 |
Ending balance (in shares) at Dec. 31, 2021 | 46,298,635 | 46,298,635 | |||
Increase (decrease) in shareholders' equity | |||||
Income / Loss for the period | (126,789) | $ (126,789) | |||
Other comprehensive Income / Loss | (29,435) | (29,435) | |||
Income tax benefit of past share issuance cost | 808 | 808 | |||
Exercise of share options | $ 8 | 1,272 | 1,280 | ||
Exercise of share options (in shares) | 152,356 | ||||
Restricted and performance share units distributed during the period | $ 27 | (27) | |||
Restricted and performance share units distributed during the period (in shares) | 505,799 | ||||
Share-based compensation expense | 34,204 | 34,204 | |||
Issuance of ordinary shares relating to employee stock purchase plan | $ 1 | 164 | 165 | ||
Issuance of ordinary shares relating to employee stock purchase plan (in shares) | 11,242 | ||||
Ending balance at Dec. 31, 2022 | $ 2,838 | $ 1,113,393 | $ (58,291) | $ (581,931) | $ 476,009 |
Ending balance (in shares) at Dec. 31, 2022 | 46,968,032 | 46,968,032 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | |||
Net (loss) / income | $ (126,789) | $ 329,589 | $ (125,024) |
Adjustments to reconcile net (loss) / income to net cash (used in) / generated from operating activities: | |||
Depreciation and amortization expense | 8,537 | 7,299 | 10,648 |
Share-based compensation expense | 34,204 | 25,635 | 21,831 |
Deferred tax (income) / expense | (1,470) | 3,210 | (16,419) |
Changes in fair value of contingent consideration and derivative financial instrument, net | 4,320 | 6,843 | (483) |
Unrealized foreign exchange (gains) / losses, net | (22,083) | (31,335) | 14,730 |
Change in deferred revenue | (33,642) | ||
Other non-cash items, net | 1,605 | (2,800) | |
Changes in operating assets and liabilities: | |||
Accounts receivable, prepaid expenses, and other current assets and receivables | (4,083) | (3,959) | (6,967) |
Contract asset related to CSL Behring milestone payments | (45,000) | (55,000) | |
Inventories | (6,924) | ||
Accounts payable | 9,238 | (727) | (2,701) |
Accrued expenses, other liabilities, and operating leases | 3,385 | 9,204 | 3,199 |
Net cash (used in) / generated from operating activities | (145,060) | 287,959 | (134,828) |
Cash flows from investing activities | |||
Investment in investment securities | (163,146) | 0 | |
Purchases of property, plant, and equipment | (17,688) | (17,438) | (7,271) |
Acquisition of Corlieve, net of cash acquired | (1,900) | (49,949) | |
Purchases of intangible assets | (2,213) | ||
Net cash used in investing activities | (182,734) | (67,387) | (9,484) |
Cash flows from financing activities | |||
Proceeds from issuance of ordinary shares related to employee stock option and purchase plans | 1,445 | 2,798 | 7,444 |
Proceeds from loan increment, net of debt issuance costs | 64,067 | ||
Proceeds from issuance of ordinary shares | 30,899 | ||
Share issuance costs from issuance of ordinary shares | (1,334) | ||
Repayment of debt acquired through acquisition of Corlieve | (1,572) | ||
Net cash generated from financing activities | 1,445 | 94,858 | 7,444 |
Currency effect on cash, cash equivalents and restricted cash | (1,831) | (3,757) | 3,822 |
Net (decrease) / increase in cash, cash equivalents and restricted cash | (328,180) | 311,673 | (133,046) |
Cash, cash equivalents and restricted cash at beginning of period | 559,353 | 247,680 | 380,726 |
Cash, cash equivalents and restricted cash at the end of period | 231,173 | 559,353 | 247,680 |
Cash and cash equivalents | 228,012 | 556,256 | 244,932 |
Restricted cash related to leasehold and other deposits | 3,161 | 3,097 | 2,748 |
Total cash, cash equivalents and restricted cash | 231,173 | 559,353 | 247,680 |
Supplemental cash flow disclosures: | |||
Cash paid for interest | (9,247) | (6,539) | (4,131) |
Non-cash (decrease) / increase in accounts payables and accrued expenses and other current liabilities related to purchases of property, plant, and equipment | $ (964) | $ 1,488 | $ 630 |
General business information
General business information | 12 Months Ended |
Dec. 31, 2022 | |
General business information | |
General business information | 1. uniQure (the “Company”) was incorporated on January 9, 2012 as a private company with limited liability ( besloten vennootschap met beperkte aansprakelijkheid naamloze vennootschap The Company is registered in the trade register of the Dutch Chamber of Commerce ( Kamer van Koophandel The Company’s ordinary shares are listed on the Nasdaq Global Select Market and trade under the symbol “QURE.” |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2. 2.1 Basis of preparation The Company prepared its consolidated financial statements in compliance with generally accepted accounting principles in the United States (“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 United States (“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, 2022 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 Securities and Exchange Commission (“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 contingent consideration related to the acquisition of Corlieve Therapeutics SAS (“Corlieve”), the treatment of revenue to be recognized under the commercialization and license agreement entered into (“CSL Behring Agreement”) between the Company and CSL Behring LLC (“CSL Behring”), and the assessment of a valuation allowance on the Company’s deferred tax assets in the Netherlands and the U.S. 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 (except for uniQure Inc. and Corlieve AG) 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 ($) and the functional currency of Corlieve AG is the Swiss Franc (CHF). 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 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 can 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 7, “ Fair value measurement 2.3.5 Corlieve transaction On June 21, 2021, we entered into a share and purchase agreement (“SPA”) to acquire all of outstanding ordinary shares of Corlieve, a privately held French gene therapy company (“Corlieve Transaction”). On July 30, 2021 (“Acquisition Date”), the Company acquired Corlieve. The Company evaluated the Corlieve transaction as to whether or not the transaction should be accounted for as a business combination or asset acquisition. Refer to Note 3 “ Corlieve transaction a. Goodwill Goodwill represents the excess of the fair value of the consideration transferred over the fair value of the net assets assumed in a business combination. Goodwill is not amortized but is evaluated for impairment on an annual basis and between annual tests if we become aware of any events occurring or changes in circumstances that would more likely than not reduce the fair value of the reporting unit below its carrying amount. As of December 31, 2022 and 2021, the Company has not recognized any impairment charges related to goodwill. Refer to Note 3 “ Corlieve transaction b. Acquired research and development The Company identified various licenses that combined with the results of the research and development activities conducted in relation to its target candidate for the treatment of temporal lobe epilepsy (“AMT-260”) since incorporation of Corlieve in 2019 constitute an In-process research and development intangible asset (“IPR&D Intangible Asset”). The IPR&D Intangible Asset is considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts and is not amortized. If and when development is completed, which generally occurs when regulatory approval to market a product is obtained, the associated asset would be deemed finite-lived and would then be amortized based on its respective useful life at that point in time. As of December 31, 2022 and 2021, the Company has not recognized any impairment charges related to the IPR&D Intangible Asset. In case of abandonment, the IPR&D Intangible Asset will be written-off. In accordance with ASC 350, Intangibles – Goodwill and Other, the Company tests indefinite-lived intangible assets for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate the fair value of the IPR&D Intangible Asset is below its carrying amount. Refer to Note 3 “ Corlieve transaction c. Contingent consideration Each reporting period, the Company revalues the contingent consideration obligations associated with the Corlieve transaction 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 achieving the relevant milestones, or probability of success (“POS”), the estimated timing of achieving such milestones, and the interest rate to discount the payments. 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. Refer to Note 3 “ Corlieve transaction 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) / income per share reflects the dilution that would occur if share options or warrants to issue ordinary shares were exercised, performance or restricted share units were distributed, or shares under the employee share purchase plan were issued. However, potential ordinary shares are excluded if their effect is anti-dilutive. Refer to Note 18 “ Basic and diluted earnings per share 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, Property, Plant, and Equipment Refer to Note 2.3.5 “ Corlieve transaction 2.3.10 Investment securities consist of sovereign debt with residual maturities of less than 12 months (presented as current) and beyond (presented as non-current). The Company classifies these securities as held-to-maturity. Held-to-maturity securities are those securities in which the Company has the ability and intent to hold the security until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortized or accreted over the term of the related held-to-maturity security as an adjustment to yield using the effective interest rate method. Investments securities with original maturities of less than three months when purchased are presented within cash and cash equivalents (December 13, 2022: $21.2 million, December 31, 2021: nil). A decline in the market value of any investment security below cost that is deemed to be other than temporary results in a reduction in the carrying amount to fair value. The impairment is charged to operations and a new cost base for the security is established. Other-than-temporary impairment charges are included in interest and other income (expense), net. Interest income is recognized when earned. Refer to Note 5 “ Investment securities 2.3.11 2.3.12 The Company started producing commercial materials in April 2022 to supply CSL Behring with the Product in accordance with the June 2020 Development and Commercial Supply Agreement between the Company and CSL Behring. From this date onwards, the Company presents the costs associated with the aforementioned activities as cost of contract manufacturing. Refer to Note 4, “Collaboration arrangements and concentration of credit risk” Per ASC 330, Inventory, inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out basis. The Company capitalizes raw materials to the extent these can be used in the manufacturing of the Product. The Company uses standard costs, approximating average costs to determine its cost basis for work in progress and finished goods. The Company’s assessment of recoverability value requires the use of estimates regarding the net realizable value of its inventory balances, including an assessment of excess or obsolete inventory. As applicable, write-downs resulting from adjustments to net realizable value will be recorded to cost of contract manufacturing. 2.3.13 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. 2.3.14 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. Contract assets are presented in current assets or as non-current assets based on the timing of the right to consideration. 2.3.15 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: · Between 10 – 15 years · 5 years · Between 3 – 5 years 2.3.16 The Company records leases in accordance with ASC 842, Leases 2.3.17 Accounts payable and accrued expenses Accounts payables are invoiced amounts related to obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts payables are recognized at the amounts invoiced by suppliers. Accrued expenses are recognized for goods or services that have been acquired in the ordinary course of business. Contract liabilities, if any, are presented in accrued expenses. 2.3.18 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. 2.3.19 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. In 2016, the Company adopted a qualified 401(k) Plan for all employees located in the United States. The 401(k) Plan offers both a pre-tax and post-tax (Roth) component. Employees may contribute up to the IRS statutory limit 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. 2.3.20 Share-based compensation The Company accounts for its share-based compensation awards in accordance with ASC 718, Compensation-Stock Compensation. All 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. Compensation expense related to Performance Share Units is recognized when the Company considers achievement of the milestones to be probable. 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. 2.3.21 Revenue recognition The Company primarily generates revenue from its commercialization and license agreement with CSL Behring and its collaboration, research, and license agreements with BMS for the development and commercialization of product candidates. CSL Behring collaboration On June 24, 2020 (“Signing Date”), the Company entered into a commercialization and license agreement pursuant to which CSL Behring received exclusive global rights to etranacogene dezaparvovec (“Product”). The Company concluded that CSL Behring is a customer in accordance with ASC 606, Revenue from Contracts with Customers (i) Sale of the exclusive global rights to etranacogene dezaparvovec, our investigational gene therapy for patients with hemophilia B (the “Product”) (“License Sale”); and (ii) Generate information to support the regulatory approval of the current and next generation manufacturing process of the Product and to provide any such information generated to CSL Behring (“Manufacturing Development”). These performance obligations are considered distinct from one another, as CSL Behring can benefit from the identified service either on its own or together with other resources that are readily available to CSL Behring, and as the performance obligations are separately identifiable from other performance obligations in the CSL Behring Agreement. Refer to Note 4 “ Collaboration arrangements and concentration of credit risk Bristol-Myers Squib collaboration The Company initially entered into collaboration, research, and license agreements with Bristol-Myers Squibb (“BMS”) in 2015 (“BMS CLA”) and amended them in 2020 (“amended BMS CLA”). The agreement terminated on February 21, 2023 (“Termination Date”). The Company evaluated the initial BMS CLA and determined that its performance obligations were as follows as of the amended BMS CLA: ● Providing pre-clinical research activities (“Collaboration Revenue”); ● Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”); and ● 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”). As further discussed in Note 4, “ Collaboration arrangements and concentration of credit risk License Revenue Until the December 2020 amendment of the BMS CLA the Company recognized License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services. Following the December 2020 amendment of the BMS CLA the Company’s performance was materially completed and it had satisfied its performance obligation (see Note 4, “Collaboration arrangements and concentration of credit risk” Collaboration and Manufacturing Revenue The Company recognized Collaboration Revenue associated with optional work orders it received from BMS to provide analytical development and process development activities that were reimbursable by BMS in accordance with the BMS CLA as well as the amended BMS CLA. 2.3.22 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 employee retention credits received under the U.S. Coronavirus Aid, Relief, and Economic Security Act, income related to a settlement agreement that the Company and VectorY B.V. entered into in April 2021, as well as income from subleasing part of the Company’s Amsterdam facility. Other expense consists of expenses incurred in relation to the subleasing income. 2.3.23 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. Furthermore, research and development costs include costs of materials and costs of intangible assets purchased from others for use in research and development activities. The costs of intangibles that are purchased from others for a particular research and development project and that have no alternative future uses (in other research and development projects or otherwise) are expensed as research and development costs at the time the costs are incurred or at the time when no alternative future use is identified. 2.3.24 Income taxes are recorded in accordance with ASC 740, Income Taxes The benefits of tax positions are recognized only if those positions are more likely than not, based on the technical merits, to be sustained upon examination. 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, 2022, and 2021, the Company did not have any significant unrecognized tax benefits. 2.3.25 Recently Adopted Accounting Pronouncements ASU 2021-10: Government Assistance In November 2018, the FASB issued ASU 2021-10, Government Assistance (Topic 832) which discussed the requirements for disclosures, to be applied prospectively or retrospectively, related to transactions with a government. ASU 2021-10 is effective for fiscal years beginning after December 15, 2021. The new disclosure requirements required disclosures around 1) information about the nature of the transactions and the related accounting policy used to account for the transactions, 2) the line items on the balance sheet and income statement that are affected by the transactions, and the amounts applicable to each financial statement line item, and 3) significant terms and conditions of the transactions, including commitments and contingencies. The Company currently includes information on government grants and the adoption of ASU 2021-10 on January 1, 2022 has not had a material impact on the Company’s consolidated financial statements. Recent Accounting Pronouncements Not Yet Effective None. |
Corlieve transaction
Corlieve transaction | 12 Months Ended |
Dec. 31, 2022 | |
Corlieve transaction | |
Corlieve transaction | 3. Corlieve transaction At the Acquisition Date, the Company acquired Corlieve. Following Corlieve’s formation in November 2019, Corlieve obtained exclusive licenses to certain patents from two French research institutions that continue to collaborate with the Company. Corlieve also obtained an exclusive license from Regenxbio Inc. (“Regenxbio”) to use AAV9 to deliver any sequence that affects the expression of the Glutamate inotropic receptor kainate type subunit 2 (“GRIK2”) gene sequence in humans. Corlieve and Regenxbio simultaneously entered into a collaboration plan related to agreed joint preclinical research and development activities. At the Acquisition Date, Corlieve and its Swiss subsidiary, Corlieve Therapeutics AG, employed seven employees. Corlieve’s result for the full year 2021 was a $7.3 million loss of which $4.1 million was included in the Company’s consolidated results. The Company evaluated the Corlieve transaction as to whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. Based on the fair values of the gross assets acquired, the Company determined the screen test was not met. The Company further analyzed whether or not the acquired inputs and processes that have the ability to create outputs would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets. Identifiable assets and liabilities of Corlieve, including identifiable intangible assets, were recorded at their fair values as of the Acquisition Date, when the Company obtained control. The excess of the fair value of the consideration transferred over the fair value of the net assets acquired was recorded as goodwill. Consideration On the Acquisition Date, the Company acquired 97.7% of the outstanding ordinary shares of Corlieve in return for EUR 44.9 million ($53.3 million as of the Acquisition Date). The Company financed the Corlieve Transaction from its cash on hand. The Company acquired the remaining outstanding ordinary shares in February, July and September 2022 for a total of EUR 1.8 million ($1.9 million). In addition to the payments to acquire 100% of the outstanding ordinary shares, Corlieve’s former shareholders are eligible to receive up to EUR 40.0 million ($42.8 million as of December 31, 2022) upon achievement of certain development milestones through Phase I/II and EUR 160.0 million ($171.3 million as of December 31, 2022) upon achievement of certain milestones associated with Phase III development and obtaining approval to commercialize Corlieve’s target candidate for the treatment of temporal lobe epilepsy (“AMT-260” or “TLE”) in the United States of America and the European Union. The Company may elect to pay up to 25% of such milestone payments through the issuance of the Company’s ordinary shares. As of the Acquisition Date, the Company recorded EUR 20.2 million ($24.0 million) as a contingent liability (presented as “Non-current liability”) for the fair value of these milestone payments. Identified intangible assets The Company identified various licenses that combined with the results of the research and development activities conducted in relation to AMT-260 since incorporation of Corlieve in 2019 constitute an IPR&D Intangible Asset. The Company determined the fair value of the IPR&D Intangible Asset using a present value model based on expected cash flows. Estimating the amounts and timing of cash flows required to complete the development of AMT-260 as well as net sales, cost of goods sold, and sales and marketing costs involved considerable judgment and uncertainty. The expected cash flows are materially impacted by the probability of successfully completing the various stages of development (i.e., dosing of first patient in clinical trial, advancing into late-stage clinical development and obtaining approval to commercialize a product candidate) as well as the weighted average cost of capital of 10.4% used to discount the expected cash flows. Based on all such information and its judgment the Company estimated the fair value of the IPR&D Intangible Asset at EUR 53.6 million ($63.6 million) as of the Acquisition Date. Deferred tax liability, net Corlieve’s deferred tax assets at the time of acquisition amounted to EUR 1.5 million ($1.7 million). Recognition of the IPR&D Intangible Asset gave rise to a deferred tax liability of EUR 13.4 million ($15.9 million) at the enacted French corporate income tax rate of 25.0%. The Company consequently recorded a net deferred tax liability of EUR 11.9 million ($14.2 million as of the Acquisition Date). Changes in the net deferred tax liability after the Acquisition Date will be recorded in income tax expense in the consolidated statements of operations. Goodwill Goodwill represents the excess of total consideration over the estimated fair value of net assets acquired. The Company recorded EUR 23.9 million ($28.4 million) of goodwill in the consolidated balance sheet as of the Acquisition Date. The goodwill primarily relates to the recognition of a deferred tax liability recognized in association with the IPR&D Intangible asset of EUR 13.4 million ($15.9 million as of Acquisition Date) as well as the fair market value of the experienced workforce and potential synergies from the acquisition. The Company allocated the goodwill to its reporting unit. The Company does not expect any portion of this goodwill to be deductible for income tax purposes. Debt As of the Acquisition Date, Corlieve held a loan with outstanding amount equal to EUR 1.0 million ($1.2 million), which loan was repaid in its entirety in September 2021. As of the Acquisition Date, Corlieve also held a loan with outstanding amount equal to EUR 0.4 million ($0.4 million), which was repaid in its entirety in December 2021. Other As of the Acquisition Date, the Company also acquired other assets and assumed other liabilities, which included among others, EUR 2.9 million ($3.4 million) of current assets, which consisted of EUR 2.8 million ($3.3 million) of cash, and EUR 1.1 million ($1.3 million) of current liabilities. |
Collaboration arrangements and
Collaboration arrangements and concentration of credit risk | 12 Months Ended |
Dec. 31, 2022 | |
Collaboration arrangements and concentration of credit risk | |
Collaboration arrangements and concentration of credit risk | 4. Collaboration arrangements and concentration of credit risk CSL Behring collaboration On the Signing Date, uniQure biopharma B.V., a wholly-owned subsidiary of uniQure N.V., entered into the CSL Behring Agreement with CSL Behring, pursuant to which CSL Behring received exclusive global rights to the Product. On May 6, 2021, a day after the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the CSL Behring Agreement became fully effective (“Closing”). The Company concluded that CSL Behring is a customer in accordance with Topic 606. The Company identified two material performance obligations related to the CSL Behring Agreement: (i) License Sale; and (ii) Manufacturing Development. These performance obligations are considered distinct from one another, as CSL Behring can benefit from the identified service either on its own or together with other resources that are readily available to CSL Behring, and as the performance obligations are separately identifiable from other performance obligations in the CSL Behring Agreement. The Company continued to develop the Product between the Signing Date and Closing and performed certain reimbursable activities to fulfill the transfer of the global rights (“Additional Covenants” and together with the License the “License Sale”). The Additional Covenants are not considered distinct from the performance obligation to sell the license to CSL Behring as CSL Behring could not benefit from the Additional Covenants on their own, or have these activities be performed with readily available resources. License Sale The Company determined that the fixed upfront payment of $450.0 million and the $12.4 million that the Company received in May 2021 in relation to the Additional Covenants should be allocated to the License Sale. In addition, the Company concluded that variable milestone payments, sales milestone payments and royalties should be allocated to the License Sale performance obligation as well. The Company determined that the License Sale was completed on May 6, 2021, when it transferred the license and CSL Behring assumed full responsibility for the development and commercialization of the Product. At Closing, the Company evaluated the amounts of potential payments and the likelihood that the payments will be received. The Company utilized the most likely amount method to estimate the variable consideration to be included in the transaction price. Since the Company cannot control the achievement of regulatory and first commercial sales milestones, the Company concluded that the potential payments were constrained as of Closing. The Company determined that it would recognize revenue related to these payments only to the extent that it becomes probable that no significant reversal of recognized cumulative revenue will occur thereafter. The Company determined that achievement of a total of $55.0 million of milestone payments related to the submissions of a biologics license application (“BLA”) and market authorization application (“MAA”) was probable as of February 25, 2022, the time of filing the 2021 financial statements, and hence recorded these as license revenue in the year ended December 31, 2021. In March and April 2022, the global regulatory submissions were submitted and the Company received the $55.0 million owed to it from CSL Behring. The Company recorded $100.0 million in variable milestone revenue related to a first sale of HEMGENIX™ in the U.S. during the year ended December 31, 2022 as the Company considers the occurrence of this event to be probable following the November 2022 BLA approval of HEMGENIX™. Despite the approval of the MAA for HEMGENIX™ by the Europeans Medicines Agency (“EMA”) in February 2023, the Company did not record the $75.0 million variable milestone payment related to a first sale of HEMGENIX™ in the one of five major European countries, namely France, Germany, Italy, Spain, and the United Kingdom, as license revenue in the year ended December 31, 2022. The Company considers that the milestone is only owed if achieved prior to July 2, 2023, which is contingent on factors outside the Company’s control and thus the Company determined that occurrence was not probable as of December 31, 2022. The Company is also eligible to receive up to $1.3 billion in additional payments based on the achievement of commercial milestones. The CSL Behring Agreement also provides that the Company will be eligible to receive tiered double-digit royalties in a range of up to a low-twenties percent of net sales of the Product based on sales thresholds. The Company will include payments related to sales milestones in the transaction price when their achievement becomes probable, and it will include royalties on the sale of Product once these have been earned. The Company recognized $100.0 million and $517.4 million of revenues related to the License Sale in the years ended December 31, 2022 and December 31, 2021, respectively (nil in 2020). The Company records expenses related to its existing license and other agreements as well as its financial advisor for a high single digit percentage of any such revenue recognized associated to meeting a milestone. Manufacturing Development The Company determined that the $50.0 million variable milestone payment related to Manufacturing Development should be allocated to the Manufacturing Development performance obligation. The Company concluded that this milestone payment represents the stand-alone selling price (“SSP”) of the services based on the estimated cost of providing the services including a reasonable margin. Manufacturing Development includes providing information regarding a next generation manufacturing process of the Product to CSL Behring. CSL Behring did not request such services during the year ended December 31, 2022. The variable consideration will be reduced if the Company does not complete the development by pre-agreed dates following BLA, respectively MAA approval. The Company utilized the most likely amount method to estimate the variable consideration to be included in the transaction price. As of December 31, 2022, the Company has not recognized any revenue related to the Manufacturing Development milestone. Contract manufacturing On the Signing Date, the Company and CSL Behring entered into a development and commercial supply agreement, pursuant to which, among other things, the Company will supply the Product to CSL Behring at an agreed-upon price commensurate with the SSP. The Company will be responsible for supplying development and commercial Product until such time that these capabilities may be transferred to CSL Behring or a designated contract manufacturing organization. On September 6, 2022, CSL Behring notified the Company of its intent to transfer manufacturing technology related to the Product in the coming years to a third-party contract manufacturer designated by CSL Behring. CSL Behring also requested that the Company continue to serve as a manufacturer of the Product after the Company completes the technology transfer to a third party. The Company and CSL Behring are in the process of negotiating the terms of the transfer of manufacturing responsibility pursuant to the CSL Behring Agreement. The Company generated $1.7 million contract manufacturing revenue from sales to CSL Behring. The Company recognizes contract manufacturing revenue when CSL Behring obtains control of the Product. The Company incurred $2.1 million of cost in relation to its contract manufacturing activities during the year ended December 31, 2022. Collaboration services Following Closing, the Company was facilitating the completion of the HOPE-B clinical trial on behalf of CSL Behring until CSL Behring took over the execution of the clinical trials in December 2022. Activities related to on-demand development services as well as activities related to the completing the HOPE-B clinical trial are reimbursed by CSL Behring at an agreed full-time-employee rate (“FTE-rate”) and CSL Behring also reimburses agreed third-party expenses incurred in relation to performing these activities. The Company concluded that these rights at Closing do not represent material rights. The Company recognized $3.0 million of collaboration revenue in the year ended December 31, 2022, compared to $2.4 million and nil in the same periods in 2021 and 2020. Accounts eceivable and ontract asset As of December 31, 2022, the Company recorded accounts receivable of $2.2 million from CSL Behring related to collaboration services as well as a contract asset of $100.0 million expected to be received from CSL Behring following the first sale of HEMGENIX™ in the U.S in 2023. As of December 31, 2021, the Company recorded accounts receivable of $2.9 million from CSL Behring related to collaboration services as well as a contract asset of $55.0 million associated with milestone payments due upon CSL Behring’s global regulatory submissions for HEMGENIX™. Bristol-Myers Squibb collaboration 2015 agreement In May 2015, the Company entered into the BMS CLA and various related agreements with BMS, which the Company collectively refers to as the BMS CLA, which provided BMS with exclusive access to the Company’s gene therapy technology platform for the research, development and commercialization of therapeutics aimed at multiple Collaboration Targets. The initial four-year research term under the collaboration terminated on May 21, 2019. 2020 amendment On December 1, 2020, the Company and BMS entered into the amended BMS CLA. Under the amended BMS CLA, BMS was limited to four Collaboration Targets. For a period of one-year from the effective date of the amended BMS CLA, BMS was able to replace up to two of the four active Collaboration Targets with two new targets in the field of cardiovascular disease. The Company continued to be eligible to receive research, development, and regulatory milestone payments of up to $217.0 million for each Collaboration Target, if defined milestones had been achieved. Since the December 2020 amendment, BMS no longer was entitled to designate a fifth to tenth Collaboration Targets and as such the Company’s remaining obligations under the amended BMS CLA were substantially reduced. The Company also no longer was entitled to receive up to an aggregate $16.5 million in target designation payments for the research, development and regulatory milestone payments associated with the fifth to tenth Collaboration Targets. For as long as any of the four Collaboration Targets were being advanced, BMS might have placed a purchase order to be supplied with research, clinical and commercial supplies. The amended BMS CLA did not extend the initial four-year research term that expired in May 2019. BMS could place purchase orders to be provided with limited services primarily related to analytical and development efforts in respect of the four Collaboration Targets. BMS could have requested such services for a period not to exceed the earlier of (i) the completion of all activities under a Research Plan and (ii) November 30, 2023. BMS continued to reimburse the Company for these services. 2022 Termination On November 21, 2022, the Company received written notice that BMS is terminating the BMS CLA as amended effective February 21, 2023. Services to BMS were rendered by the Dutch operating entity. Total collaboration and license revenue generated with BMS are as follows (presented as revenue from a related party up until the effective date of the amended BMS CLA and presented as revenue after the effective date): Years ended December 31, 2022 2021 2020 (in thousands) Bristol Myers Squibb $ 1,752 $ 4,176 $ 37,514 $ 1,752 $ 4,176 $ 37,514 Amounts owed by BMS in relation to the Collaboration and License Revenue are as follows (presented as “Accounts receivables” as of December 31, 2022 and 2021: December 31, December 31, 2022 2021 (in thousands) Bristol Myers Squibb $ 136 $ 914 Total $ 136 $ 914 License Revenue The Company recognized no License Revenue for the year ended December 31, 2022 (December 31, 2021: nil million, December 31, 2020: $33.0 million). In 2015 the Company received $75.1 million of payments that it allocated to License Revenue. The Company recognized 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 included variable consideration related to any research, development, and regulatory milestone payments, in the transaction price once it considered it probable that including these payments in the transaction price would not result in the reversal of cumulative revenue recognized. Due to the significant uncertainty surrounding the development of gene-therapy product candidates and the dependence on BMS’s performance and decisions, the Company with the exception of a $4.4 million research milestone payment received and recorded as License Revenue in December 2020 did not consider this probable as of December 31, 2021. No variable consideration became due prior to the termination of the amended BMS CLA on February 21, 2023. Under the amended BMS CLA, the Company would have recognized License Revenue related to product sales by BMS from any of the Collaboration Targets when the sales would have occurred. The Company was eligible to receive net sales-based milestone payments and tiered mid-single to low double-digit royalties on product sales. Collaboration Revenue The Company recognized collaboration revenues associated with Collaboration Target-specific pre-clinical analytical development and process development activities that were reimbursable by BMS under the BMS CLA and the amended BMS CLA as well as other related agreements. Collaboration Revenue related to these contracted services was recognized when performance obligations were satisfied. The Company generated $1.8 million collaboration revenue for the year ended December 31, 2022 (December 31, 2021: $4.2 million; December 31, 2020: $0.2 million). |
Investment securities
Investment securities | 12 Months Ended |
Dec. 31, 2022 | |
Investment securities | |
Investment securities | 5. Investment securities The following table summarizes the Company’s investments into sovereign debt as of December 31, 2022: At December 31, 2022 Amortized cost, as adjusted Gross unrealized holding gains Gross unrealized holding losses Estimated fair value (in thousands) Current investments: Obligations of governmental agencies (held-to-maturity) $ 124,831 $ — $ (283) $ 124,548 Non-current investments: Obligations of governmental agencies (held-to-maturity) 39,984 — (43) 39,941 Total $ 164,815 $ — $ (326) $ 164,489 No investments classified as held-to-maturity were purchased in the prior years. Inputs to the fair value of the investments are considered Level 2 inputs. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2022 | |
Inventories | |
Inventories | 6. Inventories The following table summarizes the inventory balances as of December 31, 2022: December 31, December 31, 2022 2021 (in thousands) Raw materials $ 3,584 $ — Work in progress 1,874 — Finished goods 1,466 — Inventories $ 6,924 $ — |
Fair value measurement and Othe
Fair value measurement and Other non-operating (losses) / gains | 12 Months Ended |
Dec. 31, 2022 | |
Fair value measurement and Other non-operating (losses) / gains | |
Fair value measurement and Other non-operating (losses) / gains | 7. Fair value measurement and Other non-operating (losses) / gains 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 licensing and collaboration partners, 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 material financial assets include cash and cash equivalents, restricted cash and investment securities. Cash and cash equivalents and restricted cash are measured at fair value using Level 1 inputs. Restricted cash is included within “Other non-current assets” within the consolidated balance sheets. Investment securities are measured at amortized cost. The following table sets forth the balances and changes in fair values of liabilities that are measured at fair value using Level 3 inputs: Derivative Contingent financial consideration instruments Total (in thousands) Balance at December 31, 2019 $ — $ 3,075 $ 3,075 Net gains recognized in profit or loss — (2,300) (2,300) Derecognition of BMS warrants — (796) (796) Recognition of derivative financial liability of CoC-payment — 2,613 2,613 Currency translation effects — 53 53 Balance at December 31, 2020 $ — $ 2,645 $ 2,645 Amount recorded for contingent consideration on Acquisition Date of Corlieve 23,950 — 23,950 Net losses recognized in profit or loss 6,683 160 6,843 Currency translation effects (1,091) — (1,091) Balance at December 31, 2021 $ 29,542 $ 2,805 $ 32,347 Net losses recognized in profit or loss 7,080 (2,760) 4,320 Currency translation effects (1,306) (45) (1,351) Balance at December 31, 2022 $ 35,316 $ — $ 35,316 Contingent consideration The Company is required to pay up to EUR 178.8 million ($191.4 million at the December 31, 2022 foreign exchange rate) to the former shareholders of Corlieve upon the achievement of contractually defined milestones in connection with the Company’s acquisition of Corlieve (refer to Note 3 “Corlieve transaction” The fair value of the contingent consideration as of December 31, 2022 was $35.3 million (2021: $29.5 million) using discount rates ranging from 14.0% to 14.4% (December 31, 2021: 10.9% to 11.9%) as well as a 66.0% (December 31, 2021: 55.0%) likelihood of AMT-260 advancing into clinical development by no later than late 2023. If as of December 31, 2022 the Company had assumed a 100% likelihood of AMT-260 advancing into clinical development, then the fair value of the contingent consideration would have increased to $48.8 million. If as of December 31, 2022 the Company assumed that it would discontinue development of the AMT-260 program, then the contingent consideration would be released to income. Changes in fair value of the contingent liability are recognized within research and development expenses in the consolidated statements of operations. As of December 31, 2022, the Company classified $26.0 million of the total contingent consideration of $35.3 million as current liabilities. The balance sheet classification between current and non-current liabilities is based upon the Company’s best estimate of the timing of settlement of the remaining relevant milestones. Derivative financial instruments The Company recorded the following results in other non-operating (losses) / gains related to the changes in the fair value of derivative financial instruments. Years ended December 31, 2022 2021 2020 (in thousands) Other non-operating gains: Derivative gains $ 2,760 $ — $ 483 Total other non-operating gains: 2,760 — 483 Other non-operating losses: Derivative losses — (160) — Other non-operating (losses) / gains, net $ 2,760 $ (160) $ 483 Derivative financial instruments BMS Pursuant to the BMS CLA, the Company in 2015 granted BMS two warrants that were subsequently terminated in connection with the amendment to the BMS CLA on December 1, 2020. The Company granted to BMS: ● A warrant that allowed BMS to purchase a specific number of the Company’s ordinary shares such that its ownership would have equaled 14.9% immediately after such purchase (“1 st warrant”). The 1 st warrant could have been exercised on the later of (i) the date on which the Company received 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 designated the sixth new target (the seventh Collaboration Target); and ● A warrant that allowed BMS to purchase a specific number of the Company’s ordinary shares such that its ownership would have equaled 19.9% immediately after such purchase (“2 nd warrant” and together with 1 st warrant, the “warrants”). The warrant could have been exercised on the later of (i) the date on which the Company received 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 designated the ninth new target (the tenth Collaboration Target). On December 1, 2020, the Company derecognized the warrants when these were terminated in accordance with the amended BMS CLA. During the year ended December 31, 2020, the Company recognized a $3.1 million gain in non-operating (losses) / gains On December 1, 2020, as part of the amended BMS CLA, the Company and BMS agreed that upon the consummation of a change of control transaction of uniQure that occurs prior to December 1, 2026 or BMS’ delivery of a target cessation notice for all four Collaboration Targets, the Company (or its third party acquirer) shall pay to BMS a one-time, non-refundable, non-creditable cash payment of $70.0 million, provided that (x) if $70.0 million is greater than five percent (5.0%) of the net proceeds (as contractually defined) from such change of control transaction, the payment shall be an amount equal to five percent of such net proceeds, and (y) if $70.0 million is less than one percent of such net proceeds, the change of control payment shall be an amount equal to one percent of such net proceeds (“CoC-payment”). The Company determined that the CoC-payment should be recorded as a derivative financial liability as of the December 1, 2020 initial recognition and that subsequent changes in the fair market value of this derivative financial liability should be recorded in profit and loss. The fair market value of the derivative financial liability is materially impacted by the probability that market participants assign to the likelihood of the occurrence of a change of control transaction that would give rise to a CoC-payment. This probability represents an unobservable input. The Company determined the fair market value of the derivative financial liability by using a present value model based on expected cash flow. The expected cash flows are materially impacted by the probability that market participants assign to the likelihood of the occurrence of a change of control transaction within the biotechnology industry. The Company estimated this unobservable input using the best information available as of December 2021. The Company obtained reasonably available market information that it believed market participants would use in determining the likelihood of the occurrence of a change-of control transaction within the biotechnology industry. Selecting and evaluating market information involves considerable judgment and uncertainty. Based on all such information and its judgment, the Company estimated that the fair market value of the derivative financial liability (presented within “Other non-current liabilities”) as of December 31, 2021 was $2.8 million. The Company recorded a $0.2 million loss in the year ended December 31, 2021 related to an increase in the fair market value of the derivative financial liability and a $2.6 million loss in the year ended December 31, 2020 related to the initial recognition of this derivative financial liability The Company determined the fair market value of the derivative financial liability to be nil as of December 31, 2022 as no change of control transaction had been consummated prior to the termination of the amended BMS CLA on February 21, 2023. The Company considered the probability of a change of control transaction occurring before the Termination Date to be remote. This resulted in the derecognition of the derivative financial liability for the year ended December 31, 2022. Accordingly, the Company recorded a $2.8 million gain within “Other non-operating (losses) / gains” in the year ended December 31, 2022 Other As of December 31, 2022, the Company recorded $0.3 million liability related to consideration for post-acquisition services, presented within Other non-current liabilities in connection with the Company’s acquisition of Corlieve (December 31, 2021: $0.8 million). Investment securities Refer to Note 5 “ Investment securities Other |
Property, plant and equipment,
Property, plant and equipment, net | 12 Months Ended |
Dec. 31, 2022 | |
Property, plant and equipment, net | |
Property, plant and equipment, net | 8. Property, plant, and equipment, net The following table presents the Company’s property, plant, and equipment as of December 31: December 31, December 31, 2022 2021 (in thousands) Leasehold improvements $ 44,871 $ 45,372 Laboratory equipment 39,393 25,499 Office equipment 4,985 4,465 Construction-in-progress 5,409 5,069 Total property, plant, and equipment 94,658 80,405 Less accumulated depreciation (44,126) (36,900) Property, plant and equipment, net $ 50,532 $ 43,505 Total depreciation expense was $8.2 million for the year ended December 31, 2022 (December 31, 2021: $6.1 million, December 31, 2020: $5.7 million). Depreciation expense is allocated to research and development expenses and cost of contract manufacturing to the extent it relates to the Company’s manufacturing facility and equipment and laboratory 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, 2022 2021 (in thousands) Lexington, Massachusetts (United States of America) $ 20,258 $ 17,311 Amsterdam (the Netherlands) 30,252 26,160 Other 22 34 Total $ 50,532 $ 43,505 |
Right-of-use asset and lease li
Right-of-use asset and lease liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Right-of-use asset and lease liabilities | |
Right-of-use asset and lease liabilities | 9. Right-of-use asset and lease liabilities 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. In December 2021, the Company entered into a new lease for an additional facility in Lexington, Massachusetts, United States of approximately 13,501 square feet of space. The lease commenced in May 2022, is set for seven years and is non-cancellable. The lease is renewable for one five-year term. In February 2022, the Company also entered into a new lease for an additional facility in Lexington, Massachusetts, United States of approximately 12,716 square feet. The lease commenced in November 2022 and is set for a non-cancellable period of seven years and four months . The lease is renewable for one five-year term. 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 lease for the 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. In February 2020, the Company amended the agreement to sub-lease to take back one of the three floors effective March 1, 2020. The fixed lease payments to be received during the remaining term under the agreement to sub-lease amount to $4.8 million (EUR 4.5 million) as of December 31, 2022. In May 2021, the Company entered into a sublease agreement to let an additional approximately 1,080 square meters of office space to accommodate the hiring of additional full-time employees. The lease expires in October 2028 and includes an option to break the lease on October 31, 2023. Operating lease liabilities Year ended December 31, 2022 2021 2020 (in thousands) Operating lease cost $ 5,932 $ 5,306 $ 5,052 Variable lease cost 785 698 607 Sublease income (849) (907) (904) Total lease cost $ 5,868 $ 5,097 $ 4,755 The table below presents the lease-related assets and liabilities recorded on the Consolidated balance sheets. December 31, December 31, 2022 2021 (in thousands) Assets Operating lease right-of-use assets $ 32,726 25,573 Liabilities Current Current operating lease liabilities 8,382 5,774 Non-current Non-current operating lease liabilities 31,719 28,987 Total lease liabilities $ 40,101 34,761 Other information The weighted-average remaining lease term as of December 31, 2022, is 7.2 years, compared to 8.3 years as of December 31, 2021, and the weighted-average discount rate as of December 31, 2022 is 11.2% , compared to 11.3% as of December 31, 2021. The Company uses an incremental borrowing rate applicable to the lease asset. The table below presents supplemental cash flow and non-cash information related to leases. Year ended December 31, 2022 2021 2020 (in thousands) Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 7,532 $ 5,738 $ 5,769 Right-of-use asset obtained in exchange for lease obligation Operating lease $ 9,824 $ 1,699 $ — Undiscounted cash flows The table below reconciles the undiscounted cash flows as of December 31, 2022, 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, 2022. Lexington Amsterdam (1) Other Total (in thousands) 2023 $ 5,236 $ 3,042 $ 104 $ 8,382 2024 5,504 1,993 104 7,601 2025 5,859 1,993 104 7,956 2026 6,031 1,993 104 8,128 2027 6,207 1,997 104 8,308 Thereafter 9,343 7,190 469 17,002 Total lease payments $ 38,180 $ 18,208 $ 989 $ 57,377 Less: amount of lease payments representing interest payments (10,611) (6,268) (397) (17,276) Present value of lease payments 27,569 11,940 592 40,101 Less: current operating lease liabilities (5,236) (3,042) (104) (8,382) Non-current operating lease liabilities $ 22,333 $ 8,898 $ 488 $ 31,719 (1) Payments are due in EUR and have been translated at the foreign exchange rate as of December 31, 2022, of $1.07 / €1.00) |
Intangible assets, net and Good
Intangible assets, net and Goodwill | 12 Months Ended |
Dec. 31, 2022 | |
Intangible assets, net and Goodwill | |
Intangible assets, net and Goodwill | 10. Intangible assets, net and Goodwill The following table presents the Company’s acquired licenses and acquired IPR&D as of December 31: December 31, December 31, 2022 2021 (in thousands) Acquired licenses $ 2,346 $ 4,755 Less accumulated amortization (900) (2,827) Acquired licenses, net $ 1,446 $ 1,928 Acquired IPR&D Intangible Asset 57,332 60,758 Intangibles, net $ 58,778 $ 62,686 a. Acquired licenses All acquired licenses are owned by uniQure biopharma B.V, a subsidiary of the Company. The remaining weighted average life is 11.5 years as of December 31, 2022. (December 31 , 2021 10.8 years.) As of December 31, 2022, the estimated future amortization expense for each of the five succeeding years and the period thereafter is as follows: Years Amount (in thousands) 2023 $ 126 2024 126 2025 126 2026 126 2027 126 Thereafter 816 Total $ 1,446 The amortization expense related to licenses for the year ended December 31, 2022 was $0.4 million (December 31, 2021: $1.2 million; December 31, 2020: $4.6 million). In 2020, the Company disposed of a number of licenses determined to have no alternative future use. The impairment expense related to licenses for the year ended December 31, 2022 was $0.0 million (December 31, 2021: $0.0 million; December 31, 2020 $0.3 million). b. Acquired in-process research and development As part of its acquisition of Corlieve as of July 30, 2021, the Company identified certain intangible assets related to an IPR&D Intangible Asset. Refer to Note 3 “Corlieve transaction” c. Goodwill As part of its acquisition of Corlieve as of July 30, 2021, the Company recorded goodwill. Refer to Note 3 “Corlieve transaction” |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Accrued expenses and other current liabilities | |
Accrued expenses and other current liabilities | 11. Accrued expenses and other current liabilities Accrued expenses and other current liabilities include the following items: December 31, December 31, 2022 2021 (in thousands) Accruals for goods received from and services provided by vendors-not yet billed $ 11,120 $ 13,012 Personnel related accruals and liabilities 17,201 12,603 Accrued contract fulfillment costs and costs to obtain a contract 2,250 2,872 Total $ 30,571 $ 28,487 |
Long-term debt
Long-term debt | 12 Months Ended |
Dec. 31, 2022 | |
Long-term debt | |
Long-term debt | 12. Long-term debt On June 14, 2013, the Company entered into a venture debt loan facility with Hercules Capital, Inc. (formerly known as Hercules Technology Growth Capital, Inc.) (“Hercules”), which was amended and restated on June 26, 2014, and again on May 6, 2016 (“2016 Amended Facility”). On December 6, 2018, the Company signed an amendment that both refinanced the then-existing $20.0 million 2016 Amended Facility and allowed the Company to draw down an additional $15.0 million (“2018 Amended Facility”). The 2018 Amended Facility extended the loan’s maturity date from May 1, 2020 until June 1, 2023. The interest rate was adjustable and was the greater of (i) 8.85% and (ii) 8.85% plus the prime rate less 5.50% per annum. In May 2020 the Company paid a back-end fee of $1.0 million in relation to the 2016 Amended Facility. On January 29, 2021, the Company and Hercules amended the 2018 Amended Facility (“2021 Amended Facility”). Pursuant to the 2021 Amended Facility, Hercules agreed to an additional Facility of $100.0 million (“Tranche B”) increasing the aggregate principal amount of the term loan facilities from $35.0 million to up to $135.0 million. On January 29, 2021, the Company drew down $35.0 million of the Tranche B. Advances under Tranche B bore interest at a rate equal to the greater of (i) 8.25% or (ii) 8.25% plus the prime rate, less 3.25% per annum. The principal balance of $70.0 million and all accrued but unpaid interest on advances under Tranche B was due on June 1, 2023, which date could had been extended by the Company by up to two twelve-month periods. Advances under the 2021 Amended Facility could have been prepaid without charge after July 29, 2021. The back-end fee in respect of advances under the 2021 Amended Facility ranged from 1.65% to 6.85%, depending on the repayment date. In addition to Tranche B, the 2021 Amended Facility had also extended the interest only payment period of the previously funded $35.0 million term loan (“Tranche A”) from January 1, 2022 to June l, 2023. On December 15, 2021, the Company and Hercules amended and restated the 2021 Amended Facility (“2021 Restated Facility”). Pursuant to the 2021 Restated Facility, Tranche A and Tranche B of the 2021 Amended Facility with a total outstanding balance of $70.0 million were consolidated into one tranche with a total commitment of $100.0 million. The Company drew down an additional $30.0 million, resulting in total principal outstanding as of December 31, 2021 of $100.0 million. The 2021 Restated Facility extended the loan’s maturity date from June 1, 2023 until December 1, 2025. The interest-only period was extended from January 1, 2023 to December 1, 2024, or December 1, 2025 if, prior to June 30, 2024, either (a) the BLA for AMT-061 is approved by the U.S. Food and Drug Administration (“FDA”) or (b) AMT-130 is advanced into a pivotal trial. On November 22, 2022, the FDA approved the BLA for AMT-061 resulting in the extension of the interest-only period to December 1, 2025. The Company is required to repay the entire principal balance on the maturity date. The interest rate is adjustable and is the greater of (i) 7.95% and (ii) 7.95% plus the prime rate less 3.25% per annum. Under the 2021 Restated Facility, the Company owes a back-end fee of $2.5 million on June 1, 2023 and a back-end fee of $4.85 million on the maturity date. The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2021 Restated Facility was $103.8 million as of December 31, 2022, compared to an amortized cost of $101.6 million for the 2021 Restated Facility as of December 31, 2021, and is recorded net of discount and debt issuance costs. The foreign currency loss on the loan was $5.8 million in 2022 (2021: loss of $5.3 million; 2020: gain of $3.1 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) 2022 $ 11.5 2021 7.2 2020 3.7 As a covenant in the 2021 Restated 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 (i) 65% of the outstanding balance of principal due or (ii) 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. Following the approval of the BLA by the FDA for AMT-061 in November 2022, the Company, beginning on April 1, 2024, is required to keep a minimum of unrestricted cash of at least 30% of the loan amount outstanding. In combination with other covenants, the 2021 Restated 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 to its shareholders. The Company secured the facilities by directly or indirectly pledging its total assets of $705.0 million with the exception of $63.7 million of cash and cash equivalents and other current assets held by uniQure N.V and $85.2 million of other current assets and investment held by Corlieve Therapeutics SAS. The 2021 Restated Facility contain 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, 2022, the Company was in material compliance with all covenants and provisions. The aggregate maturities of the loans, including $44.5 million of coupon interest payments and financing fees, for each of the 35 months after December 31, 2022, are as follows: Years Amount (in thousands) 2023 $ 14,870 2024 12,403 2025 117,219 Total $ 144,492 |
Shareholders' equity
Shareholders' equity | 12 Months Ended |
Dec. 31, 2022 | |
Shareholders' equity | |
Shareholders' equity | 13. Shareholders’ equity As of December 31, 2022, the Company’s authorized share capital is €4.0 million (or $4.3 million when translated at an exchange rate as of December 31, 2022, of $1.07 / €1.00), divided into 80,000,000 ordinary shares, each with a nominal value of €0.05. The Company’s shareholders, at the 2021 Annual General Meeting of Stockholders held on June 16, 2021, approved an increase in the number of authorized ordinary shares by 20,000,000 to 80,000,000. 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, 2022, and 2021 and 2020 the Company’s other comprehensive result was restricted for payment of dividends for an accumulated other comprehensive loss of $58.3 million in 2022, an accumulated other comprehensive loss of $28.9 million in 2021, and an accumulated other comprehensive gain of $9.9 million in 2020. On March 1, 2021, the Company entered into a Sales Agreement with SVB Leerink LLC (“SVB Leerink”) with respect to an at-the-market (“ATM”) offering program, under which the Company may, from time to time in its sole discretion, offer and sell through SVB Leerink, acting as agent, its ordinary shares, up to an aggregate offering price of $200.0 million. The Company will pay SVB Leerink a commission equal to 3% of the gross proceeds of the sales price of all ordinary shares sold through it as sales agent under the Sales Agreement. In March and April 2021, the Company issued an aggregate of 921,730 ordinary shares at a weighted average price of $33.52 per ordinary share, with net proceeds of $29.6 million, after deducting underwriting discounts and net of offering expenses. The Company defers direct, incremental costs associated to this offering, except for the commission costs to SVB Leerink, which are a reduction to additional paid-in capital, and will deduct these costs from additional paid-in capital in the consolidated balance sheets proportionately to the amount of proceeds raised. During the year ended December 31, 2021, $1.3 million of direct, incremental costs were deducted from additional paid-in capital (nil for the year ended December 31, 2022). Following the Closing of the CSL Behring transaction, the Company consumed its tax net operating loss carryforwards from the years 2011 to 2018. The Company allocated the tax benefit from the release of the valuation allowance related to net operating loss carryforwards generated by share issuance costs incurred in 2014, 2015, 2017 and 2018 to additional paid-in capital. This resulted is an increase of additional paid-in capital of $3.0 million in the year ended December 31, 2021. The Company recorded $0.8 million increase of additional paid-in capital in the year ended December 31, 2022 resulting from the release of valuation allowance for the tax benefit of share issuance costs incurred in 2018, 2019 and 2021 within the Netherlands. |
Share-based compensation
Share-based compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-based compensation | |
Share-based compensation | 14. 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, 2022 2021 2020 (in thousands) Cost of manufacturing services revenue $ 323 $ — $ — Research and development 18,402 12,834 11,995 Selling, general and administrative 15,479 12,801 9,836 Total $ 34,204 $ 25,635 $ 21,831 Share-based compensation expense recognized by award type was as follows: Year ended December 31, 2022 2021 2020 (in thousands) Award type/ESPP Share options $ 13,425 $ 12,477 $ 11,434 Restricted share units 15,486 11,347 7,364 Performance share units 5,267 1,783 2,990 Employee share purchase plan 26 28 43 Total $ 34,204 $ 25,635 $ 21,831 As of December 31, 2022, 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 $ 24,420 2.48 Restricted share units 24,924 1.90 Performance share units 184 0.14 Total $ 49,528 2.18 The Company satisfies the exercise of share options and vesting of Restricted Share Units (“RSUs”) and Performance Share Units (“PSUs”) through newly issued ordinary 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”). As of December 31, 2022, no fully vested share options are outstanding (December 31, 2021: 14,000) under 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, 2018 and 2021, 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, 3,000,000 shares in 2018 and 4,000,000 shares in 2021 for a total of 12,601,471 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, 2022: 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, 2021 3,308,325 $ 31.02 7.05 $ 8,660 Granted 1,426,966 $ 15.90 Forfeited (204,224) $ 38.29 Expired (154,794) $ 36.86 Exercised (138,356) $ 7.81 Outstanding at December 31, 2022 4,237,917 $ 26.13 7.14 17,848 Thereof, fully vested and exercisable on December 31, 2022 2,139,360 $ 28.82 5.45 8,339 Thereof, outstanding and expected to vest after December 31, 2022 2,098,557 $ 23.38 8.86 9,509 Outstanding and expected to vest after December 31, 2021 1,521,500 $ 38.71 Total weighted average grant date fair value of options issued during the period (in $ millions) $ 12.9 Granted to directors and officers during the period (options, grant date fair value $ in millions) 672,908 $ 5.9 Proceeds from option sales during the period (in $ millions) $ 1.3 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, 2022 1,426,966 $ 9.04 Granted, 2021 1,174,893 20.95 Granted, 2020 653,852 28.08 Vested, 2022 652,635 22.27 Forfeited, 2022 (204,224) 22.17 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, 2022 2,098,557 $ 13.46 Outstanding and expected to vest, 2021 1,521,500 22.52 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 2022 2021 2020 Expected volatility 70% 75% 70% Expected terms 10 years 10 years 10 years Risk free interest rate 2.12% - 4.16% 1.21 - 1.86% 0.76% - 1.44% 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) 2022 138,356 $ 1,848 2021 241,496 5,046 2020 498,678 11,927 Restricted Share Units The following table summarizes the RSU activity for the year ended December 31, 2022: RSU Weighted average Number of grant-date fair ordinary shares value Non-vested at December 31, 2021 710,617 $ 38.89 Granted 1,604,533 $ 16.10 Vested (292,688) $ 39.31 Forfeited (203,688) $ 23.39 Non-vested at December 31, 2022 1,818,774 $ 20.46 Total weighted average grant date fair value of RSUs granted during the period (in $ millions) $ 25.8 Granted to directors and officers during the period (shares, $ in millions) 380,288 $ 6.0 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 2022 1,604,533 $ 16.10 2021 574,921 36.14 2020 376,799 48.18 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) 2022 $ 5,104 2021 8,063 2020 12,156 RSUs generally vest over one to three years . RSUs granted to non-executive directors will vest one year from the date of grant. Performance Share Units The following table summarizes the PSU activity for the year ended December 31, 2022: PSU Weighted average Number of grant-date fair ordinary shares value Non-vested at December 31, 2021 632,930 $ 33.54 Granted 34,700 $ 15.11 Vested (213,145) $ 40.46 Forfeited (53,795) $ 29.35 Non-vested at December 31, 2022 400,690 $ 28.82 Total weighted average grant date fair value of PSUs granted during the period (in $ millions) $ 0.5 The Company granted shares to certain employees in September and December 2021 and various dates during the year ended December 31, 2022 that will be earned upon achievement of defined milestones. Earned shares will vest upon the later of a minimum service period of one year or three years , or the achievement of defined milestones, subject to the grantee’s continued employment. In addition, portions of the December 2021 granted to executives and other members of senior management are subject to achieving a minimum total shareholder return relative to the Nasdaq biotechnology index. The Company recognizes the compensation cost related to these grants to the extent it considers achievement of the milestones to be probable. Achievement of one of the total five defined milestones was met and one of the five defined milestones was considered probable as of December 31, 2022. In January 2018 and January and February 2019, the Company awarded PSUs to its executives and other members of senior management. These PSUs were earned in January 2019 and January 2020, based on the Board of Directors’ (the “Board”) assessment of the level of achievement of agreed upon performance targets through December 31, 2018, and December 31, 2019, respectively. The PSUs awarded for the year ended December 31, 2018 vested in February 2021 and the PSUs awarded for the year ended December 31, 2019 vested in January 2022. The following table summarizes information about the weighted average grant-date fair value of the PSUs determined as of the date those were earned for the 2019 PSUs, and the date of the grant for the 2021 and 2022 PSUs: Granted Weighted average during the year grant ‑ date fair value 2022 34,700 $ 15.11 2021 555,600 $ 30.19 2020 91,003 $ 57.56 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) 2022 $ 4,450 2021 5,074 2020 21,852 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, 2022, 11,242 shares have been issued (December 31, 2021: 4,724 and December 31, 2020: 6,181). As of December 31, 2022, a total of 116,060 ordinary shares remain available for issuance under the ESPP plan. |
Expenses by nature
Expenses by nature | 12 Months Ended |
Dec. 31, 2022 | |
Expenses by nature | |
Expenses by nature | 15. Expenses by nature Operating expenses excluding expenses presented in other expenses included the following expenses by nature: Years ended December 31, 2022 2021 2020 (in thousands) Employee-related expenses $ 119,903 $ 96,161 $ 75,926 Laboratory and development expenses 65,964 36,014 35,977 Office and housing expenses 17,612 14,638 13,388 Legal and advisory expenses 15,782 24,767 17,370 Other operating expenses 8,510 10,528 8,772 Patent and license expenses 9,548 3,748 2,899 Depreciation and amortization expenses 8,250 7,299 10,648 Fair value loss - Corlieve contingent consideration 7,081 6,683 - Total $ 252,650 $ 199,838 $ 164,980 Details of employee-related expenses for the years ended December 31 are as follows: Years ended December 31, 2022 2021 2020 (in thousands) Wages and salaries $ 63,704 $ 53,078 $ 40,919 Share-based compensation expenses 33,881 25,635 21,831 Social security costs 5,179 4,496 4,068 Health insurance 4,148 3,161 2,271 Contractor expenses 3,959 3,170 2,423 Other employee expenses 6,365 4,570 2,635 Pension costs - defined contribution plans 2,667 2,051 1,779 Total $ 119,903 $ 96,161 $ 75,926 |
Other income
Other income | 12 Months Ended |
Dec. 31, 2022 | |
Other income. | |
Other income | 16. Other income Other income during the year ended December 31, 2022 was $7.2 million compared to $12.3 million and $3.3 million during the same periods in 2021 and 2020, respectively. Other income in 2022, 2021 and 2020 includes income from payments received from European authorities to subsidize the Company’s research and development efforts in the Netherlands. The amount recognized in the year ended December 31, 2022 was $5.6 million compared to $5.3 million in 2021 and $1.9 million in 2020. In addition, other income included $2.6 million of employee retention credits received under the U.S. Coronavirus Aid, Relief, and Economic Security Act, during the year ended December 31, 2021. No such income was received in the years ended December 31, 2022 or December 31, 2020. An additional $3.0 million of other income was recorded in the year ended December 31, 2021, related to the receipt by the Company of 69,899 shares of VectorY B.V. in conjunction with a settlement agreement that the Company and VectorY B.V. entered into in April 2021. In the year ended December 31, 2022, the Company recognized $0.3 million of other income related to the equity stake received in VectorY. No such income was recorded in the year ending December 31, 2020. In 2022, 2021 and 2020 the Company’s other income also consisted of income from the subleasing of a portion of the Amsterdam facility while other expense consists of expenses incurred in relation to the subleasing income. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income taxes | |
Income taxes | 17. Income taxes a. Income tax (benefit) / expense Due to the uncertainty surrounding the realization of favorable tax attributes in future tax returns, the Company has recorded a valuation allowance against the Company’s net deferred tax assets in the Netherlands. The Company released a full valuation allowance against the Company’s net deferred tax assets in the United States as of December 31, 2020. In connection with the Corlieve acquisition, the Company recognized a deferred tax liability related to acquired identifiable intangible assets and a deferred tax asset for net operating tax loss carryforwards for a net of EUR 11.9 million ($14.2 million) as of the Acquisition Date. There are no significant unrecognized tax benefits as of December 31, 2022 and 2021. For the years ended December 31, 2022, 2021 and 2020, (loss) / income before income tax benefit / (expense) consists of the following: Years ended December 31, 2022 2021 2020 (in thousands) Dutch operations $ (96,872) $ 348,400 $ (130,493) U.S. operations (14,934) (12,737) (10,950) Other (16,453) (2,857) — Total $ (128,259) $ 332,806 $ (141,443) The income tax benefit / (expense) for the years ended December 31, 2022, 2021 and 2020, consists of the following: Years ended December 31, 2022 2021 2020 (in thousands) Current tax (expense) Other $ (24) $ (7) $ — Total current tax (expense) $ (24) $ (7) $ — Deferred tax benefit / (expense) Dutch operations $ (808) $ (3,047) $ — U.S. operations (1,075) (771) 16,419 Other 3,377 608 — Total deferred tax benefit / (expense) $ 1,494 $ (3,210) $ 16,419 Total income tax benefit / (expense) $ 1,470 $ (3,217) $ 16,419 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 (loss) / income before income tax benefit / (expense) for the years ended December 31, 2022, 2021 and 2020, is as follows: Years ended December 31, 2022 2021 2020 (in thousands) (Loss) / income before income tax benefit / (expense) for the period $ (128,259) $ 332,806 $ (141,443) Expected income tax benefit / (expense) at the tax rate enacted in the Netherlands (2022: 25.8%, 2021: 25.0%, 2020: 25.0%) 33,091 (83,201) 35,361 Non-deductible expenses (11,129) (9,182) (5,041) Other net change in valuation allowance (20,591) 88,857 (30,568) Difference in tax rates between the Netherlands and the U.S. as well as other foreign countries 99 309 247 Release of valuation allowance related to expected future taxable income of U.S. operations — — 16,419 Income tax benefit / (expense) $ 1,470 $ (3,217) $ 16,419 Non-deductible expenses predominantly relate to share-based compensation expenses. These expenses affected the effective tax rate by an amount of $8.5 million in 2022 (2021: $6.7 million; 2020: $5.8 million). The fair value loss on contingent consideration affected the effective tax rate by an amount of $1.9 million in 2022 ($2.0 million and nil in 2021 and 2020, respectively). c. The tax effects of temporary differences and carryforwards that give rise to significant portions of deferred tax assets and deferred tax liabilities as of December 31, 2022 and 2021 are as follows: Years ended December 31, 2022 2021 (in thousands) Deferred tax assets: Net operating loss carryforwards $ 84,633 $ 71,917 Operating lease liabilities 10,612 9,300 Intangible assets 3,826 2,039 Accrued expenses and other current liabilities 1,862 1,312 Property, plant and equipment 510 971 Inventory — 148 Research and development tax credit carryforwards 144 105 Interest carryforwards 3,697 — Total deferred tax assets $ 105,284 $ 85,792 Less valuation allowance (74,547) (60,289) Deferred tax assets, net of valuation allowance $ 30,737 $ 25,503 Acquired IPR&D Intangible Asset (15,033) (15,189) Operating lease right-of-use assets (9,323) (7,493) Other current assets and receivables (110) (87) Deferred tax liability $ (24,466) $ (22,769) Net deferred tax asset $ 6,271 $ 2,734 Changes in the valuation allowance were as follows: Years ended December 31, 2022 2021 2020 (in thousands) January 1, $ 60,289 $ 150,113 $ 109,856 Changes recorded in the statement of operations 20,593 (88,858) 30,568 Changes recorded in equity (972) — — Increase related to 2021 and 2020 Dutch tax reforms — 1,897 18,287 Valuation allowance assumed in Corlieve acquisition — 545 — Release of valuation allowance related to expected current year and future periods recorded in profit and loss — — (16,419) Other changes including currency translation adjustments (5,363) (3,408) 7,821 December 31, $ 74,547 $ 60,289 $ 150,113 The Company released the full valuation allowance against the Company’s net deferred assets in the United States as of December 31, 2020. Included within changes recorded in the statement of operations for the year ended December 31, 2020 are benefits of $1.2 million from the utilization of U.S. net operating loss carryforwards. The valuation allowance as of December 31, 2022 is primarily related to net operating loss carryforwards in the Netherlands. Netherlands As of December 31, 2022, the total amount of net operating losses carried forward under the Dutch tax regime was $264.0 million (December 31, 2021: $228.5 million, 2020: $588.2 million). The Company has historically recorded a full valuation allowance. The Company evaluates all positive and negative evidence including future income from the CSL Behring Agreement in assessing the need for such a full valuation allowance. Management considered reversing taxable temporary differences, projected future taxable income and tax-planning strategies in making this assessment. The Company concluded that as of December 31, 2022, December 31, 2021 and December 31, 2020 it is more likely than not that the remaining deferred tax assets will not be realized. The Company recorded $462.4 million of license revenue in May 2021 after the Closing of the CSL Behring transaction. The Company recorded such revenue in its Dutch tax return related to the 12-month period ended December 31, 2020, which it filed on February 10, 2022. As such, the Company filed a return showing a taxable profit in the Netherlands in 2020, which resulted in the consumption of substantially all of its Dutch net operating losses for the years 2011 to 2018. The Company’s remaining Dutch net operating tax losses carried forward relate to 2019 and 2022. The Company allocated the tax benefit from the release of the valuation allowance related to net operating loss carryforwards generated by share issuance cost incurred in 2014, 2015, 2017 and 2018 to additional paid-in capital. This resulted in an increase of additional paid-in capital as well as deferred tax expenses of $3.0 million during the year ended December 31, 2021. The Company recorded $0.8 million increase of additional paid-in capital in the year ended December 31, 2022 resulting from the release of valuation allowance for the tax benefit of share issuance costs incurred in 2018, 2019 and 2021. A portion of the valuation allowance for deferred tax assets recorded as of December 31, 2022 continues to relate to follow-on offering costs incurred in 2019. Any subsequently recognized tax benefits will be credited directly to contributed capital. As of December 31, 2022, that amount was $3.3 million ($4.5 million as of December 31, 2021). The Dutch corporate tax rate for fiscal years 2020 and 2021 was 25.0%. In December 2021, further changes were enacted that raised the corporate income tax rate from 25.0% to 25.8% from 2022 onwards. In June 2021 legislation was enacted allowing for an indefinite carryforward from fiscal year 2022 onwards of existing and future net operating loss carryforwards subject to a limit of offsetting taxable profit in excess of EUR 1.0 million to 50% of the taxable profit. The fiscal periods from 2020 onwards are still open for inspection by the Dutch tax authorities. United States of America The federal corporate tax rate in the U.S. is 21.0%. In addition, the Company is subject to state income taxes resulting in a combined tax rate of 27.32% for its U.S. operation. As of December 31, 2022, an estimated $38.5 million of net operating losses remain to be carried forward. These losses will expire between 2035 and 2037. The Company’s U.S. operations generated taxable income in the fiscal years 2018 to 2022. The Company expects to continue to generate taxable income in the U.S. during the foreseeable future. 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. The fiscal periods from 2019 are still open for inspection by the Internal Revenue Service (“IRS”). To the extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the IRS or Massachusetts Department of Revenue to the extent utilized in a future period. The Company is currently not under examination by the IRS for any tax years. France The French corporate tax rate for fiscal year 2022 was 25%. In addition, the Company is subject to a surcharge of 3.3% of the 25.0% standard corporate tax rate resulting in a combined rate of 25.8%. The Company’s French operation has incurred losses since incorporation and is expected to continue incurring tax losses for the foreseeable future. The French operation as of December 31, 2022 has an estimated $23.3 million of taxable losses that are available for carry forward indefinitely. |
Basic and diluted earnings per
Basic and diluted earnings per share | 12 Months Ended |
Dec. 31, 2022 | |
Basic and diluted earnings per share | |
Basic and diluted earnings per share | 18. Basic and diluted earnings per share Basic net (loss) / income per ordinary share is computed by dividing net (loss) / income for the period by the weighted average number of ordinary shares outstanding during the period. Diluted earnings per ordinary share are calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potentially dilutive ordinary shares. For the year ended December 31, 2021, dilutive net income / (loss) per ordinary share is computed using the treasury method. As the Company has incurred a loss in the years ended December 31, 2022 and December 31, 2020, all potentially dilutive ordinary shares for these years would have an antidilutive effect, if converted, and thus have been excluded from the computation of loss per share for the years ended December 31, 2022 and December 31, 2020. Year ended December 31, 2022 2021 2020 (in thousands, except share amounts) Numerator: Net (loss) / income attributable to ordinary shares $ (126,789) $ 329,589 $ (125,024) (126,789) 329,589 Denominator: Weighted-average number of ordinary shares outstanding - basic 46,735,045 45,986,467 44,466,365 Stock options under 2014 Plans and previous plan — 746,044 — Non-vested RSUs and PSUs — 107,162 — Employee share purchase plan — 1,299 — Weighted-average number of ordinary shares outstanding - diluted 46,735,045 46,840,972 44,466,365 The following table presents ordinary share equivalents that were excluded from the calculation of diluted net income / (loss) per ordinary share for the years ended December 31, 2022, 2021 and 2020 as the effect of their inclusion would have been anti-dilutive: Year ended December 31, 2022 2021 2020 Anti-dilutive ordinary share equivalents Stock options under 2014 Plans and previous plan 4,237,917 2,576,281 2,673,279 Non-vested RSUs and PSUs 2,219,464 1,236,385 679,958 Employee share purchase plan 1,048 1,842 560 Total anti-dilutive ordinary share equivalents 6,458,429 3,814,508 3,353,797 The anti-dilutive ordinary shares are presented without giving effect to the application of the treasury method or exercise prices that exceeded the price of the Company’s ordinary shares as of December 31, 2022 and December 31, 2020. |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and contingencies | |
Commitments and contingencies | 19. In the course of its business, the Company enters as a licensee into contracts with other parties regarding 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. The Company also has obligations to make future payments that become due and payable upon the collection of milestone payments from CSL Behring. The achievement and timing of these milestones is not fixed and determinable. Relevant commitments and contingencies are further discussed in other sections of this form 10-K, such as, Corlieve transaction and Note 4 “ Collaboration arrangements and concentration of credit risk ”, amongst others. |
Related party transaction
Related party transaction | 12 Months Ended |
Dec. 31, 2022 | |
Related party transaction | |
Related party transaction | 20. Related party transaction Between June 2015 and December 2020, BMS was considered a related party due to the combination of its equity investment in the Company, the warrants as well as the potential obligations arising from the expansion of collaboration targets. On December 1, 2020, the Company entered into the amended BMS CLA. All transactions subsequent to the effective date of the amended BMS CLA are considered to no longer be with a related party due to the elimination of the potential obligations related to additional Collaboration Targets (see Note 4 “Collaboration arrangements and concentration of credit risk” “Fair value measurement” |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent events | |
Subsequent events | 21. Subsequent events On January 31, 2023, the Company announced that it had entered into a global licensing agreement for a gene therapy for amyotrophic lateral sclerosis caused by mutations in superoxide dismutase 1 with Apic Bio. The Company made an initial cash payment of $10.0 million. In addition, the Company will pay Apic Bio up to $43.0 million in milestones upon achievement of regulatory approvals in the U.S. and Europe and pre-specified annual net sales, and a tiered royalty on net sales ranging from the mid-single digits to low double digits. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of significant accounting policies | |
Basis of preparation | 2.1 Basis of preparation The Company prepared its consolidated financial statements in compliance with generally accepted accounting principles in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The consolidated financial statements have been prepared under the historical cost convention, except for derivative financial instruments and contingent consideration, which are recorded at fair value through profit or loss. The consolidated financial statements are presented in United States (“U.S.”) dollars ($), 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, 2022 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 Securities and Exchange Commission (“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 contingent consideration related to the acquisition of Corlieve Therapeutics SAS (“Corlieve”), the treatment of revenue to be recognized under the commercialization and license agreement entered into (“CSL Behring Agreement”) between the Company and CSL Behring LLC (“CSL Behring”), and the assessment of a valuation allowance on the Company’s deferred tax assets in the Netherlands and the U.S. 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 (except for uniQure Inc. and Corlieve AG) 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 ($) and the functional currency of Corlieve AG is the Swiss Franc (CHF). 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 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 can 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 7, “ Fair value measurement |
Corlieve transaction | 2.3.5 Corlieve transaction On June 21, 2021, we entered into a share and purchase agreement (“SPA”) to acquire all of outstanding ordinary shares of Corlieve, a privately held French gene therapy company (“Corlieve Transaction”). On July 30, 2021 (“Acquisition Date”), the Company acquired Corlieve. The Company evaluated the Corlieve transaction as to whether or not the transaction should be accounted for as a business combination or asset acquisition. Refer to Note 3 “ Corlieve transaction a. Goodwill Goodwill represents the excess of the fair value of the consideration transferred over the fair value of the net assets assumed in a business combination. Goodwill is not amortized but is evaluated for impairment on an annual basis and between annual tests if we become aware of any events occurring or changes in circumstances that would more likely than not reduce the fair value of the reporting unit below its carrying amount. As of December 31, 2022 and 2021, the Company has not recognized any impairment charges related to goodwill. Refer to Note 3 “ Corlieve transaction b. Acquired research and development The Company identified various licenses that combined with the results of the research and development activities conducted in relation to its target candidate for the treatment of temporal lobe epilepsy (“AMT-260”) since incorporation of Corlieve in 2019 constitute an In-process research and development intangible asset (“IPR&D Intangible Asset”). The IPR&D Intangible Asset is considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts and is not amortized. If and when development is completed, which generally occurs when regulatory approval to market a product is obtained, the associated asset would be deemed finite-lived and would then be amortized based on its respective useful life at that point in time. As of December 31, 2022 and 2021, the Company has not recognized any impairment charges related to the IPR&D Intangible Asset. In case of abandonment, the IPR&D Intangible Asset will be written-off. In accordance with ASC 350, Intangibles – Goodwill and Other, the Company tests indefinite-lived intangible assets for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate the fair value of the IPR&D Intangible Asset is below its carrying amount. Refer to Note 3 “ Corlieve transaction c. Contingent consideration Each reporting period, the Company revalues the contingent consideration obligations associated with the Corlieve transaction 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 achieving the relevant milestones, or probability of success (“POS”), the estimated timing of achieving such milestones, and the interest rate to discount the payments. 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. Refer to Note 3 “ Corlieve transaction |
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) / income per share | 2.3.8 The Company follows the provisions of ASC 260, Earnings Per Share Diluted net (loss) / income per share reflects the dilution that would occur if share options or warrants to issue ordinary shares were exercised, performance or restricted share units were distributed, or shares under the employee share purchase plan were issued. However, potential ordinary shares are excluded if their effect is anti-dilutive. Refer to Note 18 “ Basic and diluted earnings per share |
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, Property, Plant, and Equipment Refer to Note 2.3.5 “ Corlieve transaction |
Investment securities | 2.3.10 Investment securities consist of sovereign debt with residual maturities of less than 12 months (presented as current) and beyond (presented as non-current). The Company classifies these securities as held-to-maturity. Held-to-maturity securities are those securities in which the Company has the ability and intent to hold the security until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortized or accreted over the term of the related held-to-maturity security as an adjustment to yield using the effective interest rate method. Investments securities with original maturities of less than three months when purchased are presented within cash and cash equivalents (December 13, 2022: $21.2 million, December 31, 2021: nil). A decline in the market value of any investment security below cost that is deemed to be other than temporary results in a reduction in the carrying amount to fair value. The impairment is charged to operations and a new cost base for the security is established. Other-than-temporary impairment charges are included in interest and other income (expense), net. Interest income is recognized when earned. Refer to Note 5 “ Investment securities |
Accounts receivable | 2.3.11 |
Inventories | 2.3.12 The Company started producing commercial materials in April 2022 to supply CSL Behring with the Product in accordance with the June 2020 Development and Commercial Supply Agreement between the Company and CSL Behring. From this date onwards, the Company presents the costs associated with the aforementioned activities as cost of contract manufacturing. Refer to Note 4, “Collaboration arrangements and concentration of credit risk” Per ASC 330, Inventory, inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out basis. The Company capitalizes raw materials to the extent these can be used in the manufacturing of the Product. The Company uses standard costs, approximating average costs to determine its cost basis for work in progress and finished goods. The Company’s assessment of recoverability value requires the use of estimates regarding the net realizable value of its inventory balances, including an assessment of excess or obsolete inventory. As applicable, write-downs resulting from adjustments to net realizable value will be recorded to cost of contract manufacturing. |
Prepaid expenses | 2.3.13 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. |
Other (non) current assets | 2.3.14 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. Contract assets are presented in current assets or as non-current assets based on the timing of the right to consideration. |
Property, plant, and equipment | 2.3.15 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: · Between 10 – 15 years · 5 years · Between 3 – 5 years |
Leases | 2.3.16 The Company records leases in accordance with ASC 842, Leases |
Accounts payable and accrued expenses | 2.3.17 Accounts payable and accrued expenses Accounts payables are invoiced amounts related to obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts payables are recognized at the amounts invoiced by suppliers. Accrued expenses are recognized for goods or services that have been acquired in the ordinary course of business. Contract liabilities, if any, are presented in accrued expenses. |
Long-term debt | 2.3.18 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 | 2.3.19 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. In 2016, the Company adopted a qualified 401(k) Plan for all employees located in the United States. The 401(k) Plan offers both a pre-tax and post-tax (Roth) component. Employees may contribute up to the IRS statutory limit 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 | 2.3.20 Share-based compensation The Company accounts for its share-based compensation awards in accordance with ASC 718, Compensation-Stock Compensation. All 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. Compensation expense related to Performance Share Units is recognized when the Company considers achievement of the milestones to be probable. 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 | 2.3.21 Revenue recognition The Company primarily generates revenue from its commercialization and license agreement with CSL Behring and its collaboration, research, and license agreements with BMS for the development and commercialization of product candidates. CSL Behring collaboration On June 24, 2020 (“Signing Date”), the Company entered into a commercialization and license agreement pursuant to which CSL Behring received exclusive global rights to etranacogene dezaparvovec (“Product”). The Company concluded that CSL Behring is a customer in accordance with ASC 606, Revenue from Contracts with Customers (i) Sale of the exclusive global rights to etranacogene dezaparvovec, our investigational gene therapy for patients with hemophilia B (the “Product”) (“License Sale”); and (ii) Generate information to support the regulatory approval of the current and next generation manufacturing process of the Product and to provide any such information generated to CSL Behring (“Manufacturing Development”). These performance obligations are considered distinct from one another, as CSL Behring can benefit from the identified service either on its own or together with other resources that are readily available to CSL Behring, and as the performance obligations are separately identifiable from other performance obligations in the CSL Behring Agreement. Refer to Note 4 “ Collaboration arrangements and concentration of credit risk Bristol-Myers Squib collaboration The Company initially entered into collaboration, research, and license agreements with Bristol-Myers Squibb (“BMS”) in 2015 (“BMS CLA”) and amended them in 2020 (“amended BMS CLA”). The agreement terminated on February 21, 2023 (“Termination Date”). The Company evaluated the initial BMS CLA and determined that its performance obligations were as follows as of the amended BMS CLA: ● Providing pre-clinical research activities (“Collaboration Revenue”); ● Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”); and ● 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”). As further discussed in Note 4, “ Collaboration arrangements and concentration of credit risk License Revenue Until the December 2020 amendment of the BMS CLA the Company recognized License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services. Following the December 2020 amendment of the BMS CLA the Company’s performance was materially completed and it had satisfied its performance obligation (see Note 4, “Collaboration arrangements and concentration of credit risk” Collaboration and Manufacturing Revenue The Company recognized Collaboration Revenue associated with optional work orders it received from BMS to provide analytical development and process development activities that were reimbursable by BMS in accordance with the BMS CLA as well as the amended BMS CLA. |
Other income, other expense | 2.3.22 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 employee retention credits received under the U.S. Coronavirus Aid, Relief, and Economic Security Act, income related to a settlement agreement that the Company and VectorY B.V. entered into in April 2021, as well as income from subleasing part of the Company’s Amsterdam facility. Other expense consists of expenses incurred in relation to the subleasing income. |
Research and development expenses | 2.3.23 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. Furthermore, research and development costs include costs of materials and costs of intangible assets purchased from others for use in research and development activities. The costs of intangibles that are purchased from others for a particular research and development project and that have no alternative future uses (in other research and development projects or otherwise) are expensed as research and development costs at the time the costs are incurred or at the time when no alternative future use is identified. |
Income taxes | 2.3.24 Income taxes are recorded in accordance with ASC 740, Income Taxes The benefits of tax positions are recognized only if those positions are more likely than not, based on the technical merits, to be sustained upon examination. 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, 2022, and 2021, the Company did not have any significant unrecognized tax benefits. |
Recently Adopted Accounting Pronouncements | 2.3.25 Recently Adopted Accounting Pronouncements ASU 2021-10: Government Assistance In November 2018, the FASB issued ASU 2021-10, Government Assistance (Topic 832) which discussed the requirements for disclosures, to be applied prospectively or retrospectively, related to transactions with a government. ASU 2021-10 is effective for fiscal years beginning after December 15, 2021. The new disclosure requirements required disclosures around 1) information about the nature of the transactions and the related accounting policy used to account for the transactions, 2) the line items on the balance sheet and income statement that are affected by the transactions, and the amounts applicable to each financial statement line item, and 3) significant terms and conditions of the transactions, including commitments and contingencies. The Company currently includes information on government grants and the adoption of ASU 2021-10 on January 1, 2022 has not had a material impact on the Company’s consolidated financial statements. Recent Accounting Pronouncements Not Yet Effective None. |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of significant accounting policies | |
Schedule of estimated useful lives of depreciable property, plant and equipment | · Between 10 – 15 years · 5 years · Between 3 – 5 years |
Collaboration arrangements an_2
Collaboration arrangements and concentration of credit risk (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Collaboration arrangements and concentration of credit risk | |
Schedule of collaboration and license revenue | Years ended December 31, 2022 2021 2020 (in thousands) Bristol Myers Squibb $ 1,752 $ 4,176 $ 37,514 $ 1,752 $ 4,176 $ 37,514 |
Schedule of amounts owed in relation to collaboration | December 31, December 31, 2022 2021 (in thousands) Bristol Myers Squibb $ 136 $ 914 Total $ 136 $ 914 |
Investment securities (Tables)
Investment securities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investment securities | |
Schedule of investments into sovereign debt | At December 31, 2022 Amortized cost, as adjusted Gross unrealized holding gains Gross unrealized holding losses Estimated fair value (in thousands) Current investments: Obligations of governmental agencies (held-to-maturity) $ 124,831 $ — $ (283) $ 124,548 Non-current investments: Obligations of governmental agencies (held-to-maturity) 39,984 — (43) 39,941 Total $ 164,815 $ — $ (326) $ 164,489 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventories | |
Schedule of inventory balances | December 31, December 31, 2022 2021 (in thousands) Raw materials $ 3,584 $ — Work in progress 1,874 — Finished goods 1,466 — Inventories $ 6,924 $ — |
Fair value measurement and Ot_2
Fair value measurement and Other non-operating (losses) / gains (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair value measurement and Other non-operating (losses) / gains | |
Schedule of changes in Level 3 items | Derivative Contingent financial consideration instruments Total (in thousands) Balance at December 31, 2019 $ — $ 3,075 $ 3,075 Net gains recognized in profit or loss — (2,300) (2,300) Derecognition of BMS warrants — (796) (796) Recognition of derivative financial liability of CoC-payment — 2,613 2,613 Currency translation effects — 53 53 Balance at December 31, 2020 $ — $ 2,645 $ 2,645 Amount recorded for contingent consideration on Acquisition Date of Corlieve 23,950 — 23,950 Net losses recognized in profit or loss 6,683 160 6,843 Currency translation effects (1,091) — (1,091) Balance at December 31, 2021 $ 29,542 $ 2,805 $ 32,347 Net losses recognized in profit or loss 7,080 (2,760) 4,320 Currency translation effects (1,306) (45) (1,351) Balance at December 31, 2022 $ 35,316 $ — $ 35,316 |
Schedule of other non-operating (losses) / gains | Years ended December 31, 2022 2021 2020 (in thousands) Other non-operating gains: Derivative gains $ 2,760 $ — $ 483 Total other non-operating gains: 2,760 — 483 Other non-operating losses: Derivative losses — (160) — Other non-operating (losses) / gains, net $ 2,760 $ (160) $ 483 |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, plant and equipment, net | |
Schedule of property, plant and equipment | December 31, December 31, 2022 2021 (in thousands) Leasehold improvements $ 44,871 $ 45,372 Laboratory equipment 39,393 25,499 Office equipment 4,985 4,465 Construction-in-progress 5,409 5,069 Total property, plant, and equipment 94,658 80,405 Less accumulated depreciation (44,126) (36,900) Property, plant and equipment, net $ 50,532 $ 43,505 |
Summary of long-lived assets by geographic region | December 31, December 31, 2022 2021 (in thousands) Lexington, Massachusetts (United States of America) $ 20,258 $ 17,311 Amsterdam (the Netherlands) 30,252 26,160 Other 22 34 Total $ 50,532 $ 43,505 |
Right-of-use asset and lease _2
Right-of-use asset and lease liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Right-of-use asset and lease liabilities | |
Schedule of lease cost, balance sheet and cash flow information | Year ended December 31, 2022 2021 2020 (in thousands) Operating lease cost $ 5,932 $ 5,306 $ 5,052 Variable lease cost 785 698 607 Sublease income (849) (907) (904) Total lease cost $ 5,868 $ 5,097 $ 4,755 December 31, December 31, 2022 2021 (in thousands) Assets Operating lease right-of-use assets $ 32,726 25,573 Liabilities Current Current operating lease liabilities 8,382 5,774 Non-current Non-current operating lease liabilities 31,719 28,987 Total lease liabilities $ 40,101 34,761 Year ended December 31, 2022 2021 2020 (in thousands) Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 7,532 $ 5,738 $ 5,769 Right-of-use asset obtained in exchange for lease obligation Operating lease $ 9,824 $ 1,699 $ — |
Schedule of undiscounted cash flows and minimum lease payments | Lexington Amsterdam (1) Other Total (in thousands) 2023 $ 5,236 $ 3,042 $ 104 $ 8,382 2024 5,504 1,993 104 7,601 2025 5,859 1,993 104 7,956 2026 6,031 1,993 104 8,128 2027 6,207 1,997 104 8,308 Thereafter 9,343 7,190 469 17,002 Total lease payments $ 38,180 $ 18,208 $ 989 $ 57,377 Less: amount of lease payments representing interest payments (10,611) (6,268) (397) (17,276) Present value of lease payments 27,569 11,940 592 40,101 Less: current operating lease liabilities (5,236) (3,042) (104) (8,382) Non-current operating lease liabilities $ 22,333 $ 8,898 $ 488 $ 31,719 (1) Payments are due in EUR and have been translated at the foreign exchange rate as of December 31, 2022, of $1.07 / €1.00) |
Intangible assets, net and Go_2
Intangible assets, net and Goodwill (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Intangible assets, net and Goodwill | |
Schedule of acquired licenses and acquired IPR&D intangible asset | December 31, December 31, 2022 2021 (in thousands) Acquired licenses $ 2,346 $ 4,755 Less accumulated amortization (900) (2,827) Acquired licenses, net $ 1,446 $ 1,928 Acquired IPR&D Intangible Asset 57,332 60,758 Intangibles, net $ 58,778 $ 62,686 |
Schedule of estimated future amortization expense | Years Amount (in thousands) 2023 $ 126 2024 126 2025 126 2026 126 2027 126 Thereafter 816 Total $ 1,446 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued expenses and other current liabilities | |
Schedule of accrued expenses and other current liabilities | December 31, December 31, 2022 2021 (in thousands) Accruals for goods received from and services provided by vendors-not yet billed $ 11,120 $ 13,012 Personnel related accruals and liabilities 17,201 12,603 Accrued contract fulfillment costs and costs to obtain a contract 2,250 2,872 Total $ 30,571 $ 28,487 |
Long-term debt (Tables)
Long-term debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Long-term debt | |
Schedule of interest expense | Years Amount (in millions) 2022 $ 11.5 2021 7.2 2020 3.7 |
Schedule of aggregate maturities of the loan | Years Amount (in thousands) 2023 $ 14,870 2024 12,403 2025 117,219 Total $ 144,492 |
Share-based compensation (Table
Share-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-based compensation | |
Schedule of share-based compensation expense by classification included in consolidated statements of operations and comprehensive loss | Year ended December 31, 2022 2021 2020 (in thousands) Cost of manufacturing services revenue $ 323 $ — $ — Research and development 18,402 12,834 11,995 Selling, general and administrative 15,479 12,801 9,836 Total $ 34,204 $ 25,635 $ 21,831 |
Schedule of share-based compensation expense | Year ended December 31, 2022 2021 2020 (in thousands) Award type/ESPP Share options $ 13,425 $ 12,477 $ 11,434 Restricted share units 15,486 11,347 7,364 Performance share units 5,267 1,783 2,990 Employee share purchase plan 26 28 43 Total $ 34,204 $ 25,635 $ 21,831 |
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 $ 24,420 2.48 Restricted share units 24,924 1.90 Performance share units 184 0.14 Total $ 49,528 2.18 |
Schedule of weighted-average assumptions for fair value of option issued | Year ended December 31, Assumptions 2022 2021 2020 Expected volatility 70% 75% 70% Expected terms 10 years 10 years 10 years Risk free interest rate 2.12% - 4.16% 1.21 - 1.86% 0.76% - 1.44% 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, 2021 710,617 $ 38.89 Granted 1,604,533 $ 16.10 Vested (292,688) $ 39.31 Forfeited (203,688) $ 23.39 Non-vested at December 31, 2022 1,818,774 $ 20.46 Total weighted average grant date fair value of RSUs granted during the period (in $ millions) $ 25.8 Granted to directors and officers during the period (shares, $ in millions) 380,288 $ 6.0 |
Summary of PSUs activity | PSU Weighted average Number of grant-date fair ordinary shares value Non-vested at December 31, 2021 632,930 $ 33.54 Granted 34,700 $ 15.11 Vested (213,145) $ 40.46 Forfeited (53,795) $ 29.35 Non-vested at December 31, 2022 400,690 $ 28.82 Total weighted average grant date fair value of PSUs granted during the period (in $ millions) $ 0.5 |
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, 2021 3,308,325 $ 31.02 7.05 $ 8,660 Granted 1,426,966 $ 15.90 Forfeited (204,224) $ 38.29 Expired (154,794) $ 36.86 Exercised (138,356) $ 7.81 Outstanding at December 31, 2022 4,237,917 $ 26.13 7.14 17,848 Thereof, fully vested and exercisable on December 31, 2022 2,139,360 $ 28.82 5.45 8,339 Thereof, outstanding and expected to vest after December 31, 2022 2,098,557 $ 23.38 8.86 9,509 Outstanding and expected to vest after December 31, 2021 1,521,500 $ 38.71 Total weighted average grant date fair value of options issued during the period (in $ millions) $ 12.9 Granted to directors and officers during the period (options, grant date fair value $ in millions) 672,908 $ 5.9 Proceeds from option sales during the period (in $ millions) $ 1.3 |
Summary of information about weighted average grant-date fair value of options granted | Weighted average Options grant ‑ date fair value Granted, 2022 1,426,966 $ 9.04 Granted, 2021 1,174,893 20.95 Granted, 2020 653,852 28.08 Vested, 2022 652,635 22.27 Forfeited, 2022 (204,224) 22.17 |
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, 2022 2,098,557 $ 13.46 Outstanding and expected to vest, 2021 1,521,500 22.52 |
Summary of information about options exercised | Exercised during the year Intrinsic value (in thousands) 2022 138,356 $ 1,848 2021 241,496 5,046 2020 498,678 11,927 |
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 2022 1,604,533 $ 16.10 2021 574,921 36.14 2020 376,799 48.18 |
Summary of information about the total fair value of stock that vested | Total fair value (in thousands) 2022 $ 5,104 2021 8,063 2020 12,156 |
Performance Share Awards | |
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 2022 34,700 $ 15.11 2021 555,600 $ 30.19 2020 91,003 $ 57.56 |
Summary of information about the total fair value of stock that vested | Total fair value (in thousands) 2022 $ 4,450 2021 5,074 2020 21,852 |
Expenses by nature (Tables)
Expenses by nature (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Expenses by nature | |
Schedule of operating expenses | Years ended December 31, 2022 2021 2020 (in thousands) Employee-related expenses $ 119,903 $ 96,161 $ 75,926 Laboratory and development expenses 65,964 36,014 35,977 Office and housing expenses 17,612 14,638 13,388 Legal and advisory expenses 15,782 24,767 17,370 Other operating expenses 8,510 10,528 8,772 Patent and license expenses 9,548 3,748 2,899 Depreciation and amortization expenses 8,250 7,299 10,648 Fair value loss - Corlieve contingent consideration 7,081 6,683 - Total $ 252,650 $ 199,838 $ 164,980 |
Schedule of employee-related expenses | Years ended December 31, 2022 2021 2020 (in thousands) Wages and salaries $ 63,704 $ 53,078 $ 40,919 Share-based compensation expenses 33,881 25,635 21,831 Social security costs 5,179 4,496 4,068 Health insurance 4,148 3,161 2,271 Contractor expenses 3,959 3,170 2,423 Other employee expenses 6,365 4,570 2,635 Pension costs - defined contribution plans 2,667 2,051 1,779 Total $ 119,903 $ 96,161 $ 75,926 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income taxes | |
Schedule of Income / (loss) before income tax (expense) / benefit | Years ended December 31, 2022 2021 2020 (in thousands) Dutch operations $ (96,872) $ 348,400 $ (130,493) U.S. operations (14,934) (12,737) (10,950) Other (16,453) (2,857) — Total $ (128,259) $ 332,806 $ (141,443) |
Schedule of income tax benefit / (expense) | Years ended December 31, 2022 2021 2020 (in thousands) Current tax (expense) Other $ (24) $ (7) $ — Total current tax (expense) $ (24) $ (7) $ — Deferred tax benefit / (expense) Dutch operations $ (808) $ (3,047) $ — U.S. operations (1,075) (771) 16,419 Other 3,377 608 — Total deferred tax benefit / (expense) $ 1,494 $ (3,210) $ 16,419 Total income tax benefit / (expense) $ 1,470 $ (3,217) $ 16,419 |
Schedule of reconciliation of statutory income tax rate to effective tax rate | Years ended December 31, 2022 2021 2020 (in thousands) (Loss) / income before income tax benefit / (expense) for the period $ (128,259) $ 332,806 $ (141,443) Expected income tax benefit / (expense) at the tax rate enacted in the Netherlands (2022: 25.8%, 2021: 25.0%, 2020: 25.0%) 33,091 (83,201) 35,361 Non-deductible expenses (11,129) (9,182) (5,041) Other net change in valuation allowance (20,591) 88,857 (30,568) Difference in tax rates between the Netherlands and the U.S. as well as other foreign countries 99 309 247 Release of valuation allowance related to expected future taxable income of U.S. operations — — 16,419 Income tax benefit / (expense) $ 1,470 $ (3,217) $ 16,419 |
Schedule of significant portions of deferred tax assets and deferred tax liabilities | Years ended December 31, 2022 2021 (in thousands) Deferred tax assets: Net operating loss carryforwards $ 84,633 $ 71,917 Operating lease liabilities 10,612 9,300 Intangible assets 3,826 2,039 Accrued expenses and other current liabilities 1,862 1,312 Property, plant and equipment 510 971 Inventory — 148 Research and development tax credit carryforwards 144 105 Interest carryforwards 3,697 — Total deferred tax assets $ 105,284 $ 85,792 Less valuation allowance (74,547) (60,289) Deferred tax assets, net of valuation allowance $ 30,737 $ 25,503 Acquired IPR&D Intangible Asset (15,033) (15,189) Operating lease right-of-use assets (9,323) (7,493) Other current assets and receivables (110) (87) Deferred tax liability $ (24,466) $ (22,769) Net deferred tax asset $ 6,271 $ 2,734 |
Summary of Changes in the valuation allowance | Years ended December 31, 2022 2021 2020 (in thousands) January 1, $ 60,289 $ 150,113 $ 109,856 Changes recorded in the statement of operations 20,593 (88,858) 30,568 Changes recorded in equity (972) — — Increase related to 2021 and 2020 Dutch tax reforms — 1,897 18,287 Valuation allowance assumed in Corlieve acquisition — 545 — Release of valuation allowance related to expected current year and future periods recorded in profit and loss — — (16,419) Other changes including currency translation adjustments (5,363) (3,408) 7,821 December 31, $ 74,547 $ 60,289 $ 150,113 |
Basic and diluted earnings pe_2
Basic and diluted earnings per share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Basic and diluted earnings per share | |
Schedule of basic and diluted earnings per share | Year ended December 31, 2022 2021 2020 (in thousands, except share amounts) Numerator: Net (loss) / income attributable to ordinary shares $ (126,789) $ 329,589 $ (125,024) (126,789) 329,589 Denominator: Weighted-average number of ordinary shares outstanding - basic 46,735,045 45,986,467 44,466,365 Stock options under 2014 Plans and previous plan — 746,044 — Non-vested RSUs and PSUs — 107,162 — Employee share purchase plan — 1,299 — Weighted-average number of ordinary shares outstanding - diluted 46,735,045 46,840,972 44,466,365 |
Schedule of potential dilutive common shares | Year ended December 31, 2022 2021 2020 Anti-dilutive ordinary share equivalents Stock options under 2014 Plans and previous plan 4,237,917 2,576,281 2,673,279 Non-vested RSUs and PSUs 2,219,464 1,236,385 679,958 Employee share purchase plan 1,048 1,842 560 Total anti-dilutive ordinary share equivalents 6,458,429 3,814,508 3,353,797 |
Summary of significant accoun_4
Summary of significant accounting policies (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) segment $ / shares | Dec. 31, 2021 USD ($) | |
Segment information | ||
Number of operating segments | segment | 1 | |
Pensions | ||
Current investment securities | $ 124,831,000 | |
Current and non-current classification | ||
Operating cycle period | 12 months | |
Pension benefits | Lexington | ||
Pensions | ||
Amount of employer matching contribution for every employee dollar contributed | $ 0.50 | |
Lexington. | Pension benefits | ||
Pensions | ||
Amount contributed to plan (in dollars per share) | $ / shares | $ 1 | |
Cash and Cash Equivalents | ||
Pensions | ||
Current investment securities | $ 21,200,000 | $ 0 |
Maximum | Pension benefits | Lexington | ||
Pensions | ||
Percent of employee gross pay for which the employer makes a matching contribution | 6% | |
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 |
Corlieve transaction - Provisio
Corlieve transaction - Provisional Fair Values to Contingent Consideration, Assets Acquired and Liabilities Assumed (Details) $ in Thousands, € in Millions | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jul. 30, 2021 USD ($) | Jul. 30, 2021 EUR (€) |
Consideration | ||||
Contingent consideration | $ 35,300 | |||
Recognized amounts of identifiable assets acquired and liabilities assumed | ||||
Goodwill | $ 25,581 | $ 27,633 | ||
Acquisition of Corlieve | ||||
Recognized amounts of identifiable assets acquired and liabilities assumed | ||||
Current assets including €2.8 million of cash | $ 3,400 | € 2.9 | ||
Current liabilities | (1,300) | (1.1) | ||
Deferred tax liability, net | (14,200) | (11.9) | ||
Goodwill | 28,400 | 23.9 | ||
Current assets of cash | $ 3,300 | € 2.8 |
Corlieve transaction - Narrativ
Corlieve transaction - Narrative (Details) $ in Thousands, € in Millions | 12 Months Ended | |||||||||
Sep. 30, 2021 USD ($) | Sep. 30, 2021 EUR (€) | Jul. 30, 2021 USD ($) employee Institution | Jul. 30, 2021 EUR (€) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 EUR (€) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 | Dec. 31, 2022 EUR (€) | Jul. 30, 2021 EUR (€) employee Institution | |
Business Acquisition [Line Items] | ||||||||||
Contingent consideration, net of current portion | $ 9,334 | $ 29,542 | ||||||||
Enacted tax rate | 25.80% | 25.80% | 25% | 25% | ||||||
Goodwill | $ 25,581 | $ 27,633 | ||||||||
Repayment of debt acquired through acquisition of Corlieve | 1,572 | |||||||||
Acquisition of Corlieve | ||||||||||
Business Acquisition [Line Items] | ||||||||||
Number of institutions | Institution | 2 | 2 | ||||||||
Number of employees employed | employee | 7 | 7 | ||||||||
Net loss of Corlieve and its Swiss subsidiary | 7,300 | |||||||||
Net loss from Corlieve and its Swiss subsidiary included in the consolidated results | 4,100 | |||||||||
Percentage of outstanding ordinary shares | 97.70% | 100% | 100% | 97.70% | ||||||
Value of shares issued | $ 53,300 | € 44.9 | ||||||||
Contingent consideration, net of current portion | $ 24,000 | $ 35,300 | $ 29,500 | € 20.2 | ||||||
Weighted average cost of capital | 10.40% | 10.40% | ||||||||
Provisional fair value of IPR&D intangible asset | $ 63,600 | € 53.6 | ||||||||
Deferred tax assets | 1,700 | 1.5 | ||||||||
Intangible assets | $ 15,900 | 13.4 | ||||||||
Enacted tax rate | 25% | 25% | ||||||||
Deferred tax liability, net | $ 14,200 | 11.9 | ||||||||
Goodwill | 28,400 | 23.9 | ||||||||
Repayment of debt acquired through acquisition of Corlieve | $ 1,200 | € 1 | 400 | € 0.4 | ||||||
Current assets | 3,400 | 2.9 | ||||||||
Cash | 3,300 | 2.8 | ||||||||
Current liabilities | $ 1,300 | € 1.1 | ||||||||
Acquisition of remaining outstanding ordinary shares | 1,900 | € 1.8 | ||||||||
Acquisition of Corlieve | Maximum | ||||||||||
Business Acquisition [Line Items] | ||||||||||
Consideration payable in development milestones through phase I or II | 42,800 | € 40 | ||||||||
Consideration payable in development milestones through phase III | $ (171,300) | € 160 | ||||||||
Percentage of milestones payable through the issuance of shares | 25% | 25% |
Collaboration arrangements an_3
Collaboration arrangements and concentration of credit risk - CSL Behring and Bristol-Myers Squibb collaboration - Narrative (Details) $ in Thousands | 12 Months Ended | |||||
Dec. 01, 2020 USD ($) item | Jun. 24, 2020 USD ($) | Dec. 31, 2022 USD ($) item | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2015 USD ($) | |
Collaboration arrangements | ||||||
Number of collaboration targets | item | 4 | |||||
License revenues from related party | $ 27,800 | $ 75,100 | ||||
Revenue | $ 106,483 | $ 524,002 | 37,514 | |||
Maximum | ||||||
Collaboration arrangements | ||||||
Collaboration agreement, additional payments receivable on achievement of commercial milestones | 1,300 | |||||
CSL Behring collaboration. | ||||||
Collaboration arrangements | ||||||
Revenue | 100,000 | |||||
Collaboration arrangement, variable milestone revenue not recorded | 75,000 | |||||
Upfront cash to receive upon the closing of the agreement | $ 450,000 | |||||
Other payments received | 12,400 | |||||
Accounts receivable | 2,200 | 2,900 | ||||
Contract asset | 100,000 | 55,000 | ||||
Milestone payments to be received upon achievement | $ 55,000 | |||||
Collaboration revenues from related party | $ 55,000 | |||||
Number of major European Countries, Variable Milestone Revenue Not Recorded | item | 1 | |||||
Number of Major European Countries | item | 5 | |||||
Bristol Myers Squibb | ||||||
Collaboration arrangements | ||||||
Initial research term | 4 years | |||||
License revenues from related parties | ||||||
Collaboration arrangements | ||||||
Revenue | $ 0 | 0 | 32,967 | |||
Collaboration revenues from related parties | ||||||
Collaboration arrangements | ||||||
Revenue | 136 | |||||
Collaborative Revenue Including Revenue From Related Party | ||||||
Collaboration arrangements | ||||||
Revenue | 1,800 | 4,200 | 200 | |||
Contract manufacturing revenues | ||||||
Collaboration arrangements | ||||||
Revenue | 1,717 | |||||
Contract manufacturing revenues | CSL Behring collaboration. | ||||||
Collaboration arrangements | ||||||
Revenue | $ 2,100 | |||||
BMS arrangement | ||||||
Collaboration arrangements | ||||||
Number of collaboration targets | item | 4 | |||||
Revenue | $ 1,752 | 4,176 | 37,514 | |||
BMS arrangement | CSL Behring collaboration. | ||||||
Collaboration arrangements | ||||||
Number of collaboration targets | item | 4 | |||||
Collaboration Agreement, Period From Effective Date Collaboration Targets Can Be Replaced | 1 year | |||||
Threshold Number Of New Collaboration Targets In The Field Of Cardiovascular Disease | item | 2 | |||||
BMS arrangement | Bristol Myers Squibb | ||||||
Collaboration arrangements | ||||||
Initial research term | 4 years | |||||
Number of collaboration targets | item | 4 | |||||
Collaboration Agreement, Threshold Number Of Collaboration Targets That Can Be Replaced | item | 2 | |||||
Revenue | $ 1,752 | 4,176 | 37,514 | |||
Collaboration Agreement, Threshold Research, Development And Regulatory Milestone Payments Receivable | $ 217,000 | |||||
BMS arrangement | Bristol Myers Squibb | Maximum | ||||||
Collaboration arrangements | ||||||
Number of collaboration targets | item | 4 | |||||
Collaborative revenue | CSL Behring collaboration. | ||||||
Collaboration arrangements | ||||||
Revenue | 3,000 | 2,400 | 0 | |||
Collaborative revenue | Bristol Myers Squibb | ||||||
Collaboration arrangements | ||||||
Upfront cash to receive upon the closing of the agreement | 4,400 | |||||
Variable Consideration Due | 0 | |||||
License revenue | CSL Behring collaboration. | ||||||
Collaboration arrangements | ||||||
Revenue | 100,000 | $ 517,400 | $ 0 | |||
License revenue | Bristol Myers Squibb | ||||||
Collaboration arrangements | ||||||
Maximum target designation payments to which entitled per agreement | 16,500 | |||||
Manufacturing Development [Member] | ||||||
Collaboration arrangements | ||||||
Revenue | $ 50,000 |
Collaboration arrangements an_4
Collaboration arrangements and concentration of credit risk - Amounts owed by BMS (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenues | $ 106,483 | $ 524,002 | $ 37,514 |
BMS arrangement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Amounts owed in relation to the collaboration services | 136 | 914 | |
Total revenues | 1,752 | 4,176 | 37,514 |
BMS arrangement | Bristol Myers Squibb | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Amounts owed in relation to the collaboration services | 136 | 914 | |
Total revenues | $ 1,752 | $ 4,176 | $ 37,514 |
Investment securities (Details)
Investment securities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current investments: | ||
Amortized cost, as adjusted | $ 124,831 | |
Non-current investments: | ||
Amortized cost, as adjusted | 39,984 | |
Investment securities | ||
Amortized cost, as adjusted | 164,815 | |
Gross unrealized holding losses | (326) | |
Estimated fair value | 164,489 | |
Investment purchased | 163,146 | $ 0 |
Obligations of governmental agencies | ||
Current investments: | ||
Amortized cost, as adjusted | 124,831 | |
Gross unrealized holding losses | (283) | |
Estimated fair value | 124,548 | |
Non-current investments: | ||
Amortized cost, as adjusted | 39,984 | |
Gross unrealized holding losses | (43) | |
Estimated fair value | $ 39,941 |
Inventories (Details)
Inventories (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Inventories | |
Raw materials | $ 3,584 |
Work in progress | 1,874 |
Finished goods | 1,466 |
Inventories | $ 6,924 |
Fair value measurement and Ot_3
Fair value measurement and Other non-operating (losses) / gains - Changes in Level 3 items (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Changes in Level 3 liabilities | |||
Beginning Balance | $ 32,347 | $ 2,645 | $ 3,075 |
Amount recorded for contingent consideration on Acquisition Date of Corlieve | 23,950 | ||
Net (gains) losses recognized in profit or loss | $ 4,320 | $ 6,843 | $ (2,300) |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Other Nonoperating Income (Expense). | Other Nonoperating Income (Expense). | Other Nonoperating Income (Expense). |
Derecognition of BMS warrants | $ (796) | ||
Recognition of derivative financial liability of CoC-payment | 2,613 | ||
Currency translation effects | $ (1,351) | $ (1,091) | 53 |
Ending Balance | 35,316 | 32,347 | 2,645 |
Contingent consideration. | |||
Changes in Level 3 liabilities | |||
Beginning Balance | 29,542 | ||
Amount recorded for contingent consideration on Acquisition Date of Corlieve | 23,950 | ||
Net (gains) losses recognized in profit or loss | 7,080 | 6,683 | |
Currency translation effects | (1,306) | (1,091) | |
Ending Balance | 35,316 | 29,542 | |
Derivative financial instruments | |||
Changes in Level 3 liabilities | |||
Beginning Balance | 2,805 | 2,645 | 3,075 |
Net (gains) losses recognized in profit or loss | (2,760) | 160 | (2,300) |
Derecognition of BMS warrants | (796) | ||
Recognition of derivative financial liability of CoC-payment | 2,613 | ||
Currency translation effects | $ (45) | 53 | |
Ending Balance | $ 2,805 | $ 2,645 |
Fair value measurement and Ot_4
Fair value measurement and Other non-operating (losses) / gains - Contingent Consideration (Details) $ in Thousands, € in Millions | 12 Months Ended | ||||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2022 EUR (€) | Jul. 30, 2021 USD ($) | Jul. 30, 2021 EUR (€) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Contingent consideration, net of current portion | $ 9,334 | $ 29,542 | |||
Contingent consideration | 35,300 | ||||
Current portion of contingent consideration | 25,982 | ||||
Liability related to post acquisition services | $ 300 | $ 800 | |||
Maximum | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Contingent consideration discount rate percentage | 11.90% | ||||
Minimum | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Contingent consideration discount rate percentage | 10.90% | ||||
One hundred percent likelihood of AMT-260 advancing into clinical development | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Percentage of increase in Probability of Success | 100% | ||||
Change in fair value (presented within research and development expenses) | $ 48,800 | ||||
Acquisition of Corlieve | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Contingent consideration, net of current portion | $ 35,300 | $ 29,500 | $ 24,000 | € 20.2 | |
Percentage of increase in Probability of Success | 66% | 55% | |||
Acquisition of Corlieve | Maximum | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Contingent consideration payable upon achievement of contractually defined milestones | $ 191,400 | € 178.8 | |||
Contingent consideration discount rate percentage | 14.40% | ||||
Acquisition of Corlieve | Minimum | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Contingent consideration discount rate percentage | 14% |
Fair value measurement and Ot_5
Fair value measurement and Other non-operating (losses) / gains - Derivative financial instruments (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Other non-operating gains | |||
Derivative gains | $ 2,760 | $ 483 | |
Total other non-operating gains: | 2,760 | 483 | |
Other non-operating losses | |||
Derivative losses | $ (160) | ||
Other non-operating (losses) / gains , net | $ 2,760 | $ (160) | $ 483 |
Fair value measurement and Ot_6
Fair value measurement and Other non-operating (losses) / gains - BMS warrants (Details) $ in Thousands | 12 Months Ended | ||||
Dec. 01, 2020 USD ($) item | Dec. 31, 2022 USD ($) item | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2019 USD ($) | |
Collaboration arrangements | |||||
Number of warrant types | 2 | ||||
Number of collaboration targets | 4 | ||||
Collaboration agreement, cash payable | $ | $ 70,000 | ||||
Fair value of derivative financial instruments | $ | $ 35,316 | $ 32,347 | $ 2,645 | $ 3,075 | |
Fair value of the derivative financial liability | $ | 0 | ||||
CoC-payment | |||||
Collaboration arrangements | |||||
Gain (Loss) from the recognition of the derivative financial liability | $ | (200) | (2,600) | |||
Other nonoperating (losses) / gains | CoC-payment | |||||
Collaboration arrangements | |||||
Gain (Loss) from the recognition of the derivative financial liability | $ | $ 2,800 | ||||
Non-current liabilities | |||||
Collaboration arrangements | |||||
Fair value of the derivative financial liability | $ | $ 2,800 | ||||
BMS arrangement | |||||
Collaboration arrangements | |||||
Number of collaboration targets | 4 | ||||
BMS arrangement | Bristol Myers Squibb | |||||
Collaboration arrangements | |||||
Number of collaboration targets | 4 | ||||
BMS arrangement | Bristol Myers Squibb | Maximum | |||||
Collaboration arrangements | |||||
Number of collaboration targets | 4 | ||||
BMS Warrants | Fair value hierarchy Level 3 | |||||
Collaboration arrangements | |||||
Gain (Loss) recorded due to changes in fair value of derivative asset | $ | $ 3,100 | ||||
Fair Value, Asset, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Other Nonoperating Income (Expense). | ||||
BMS Warrants | BMS arrangement | |||||
Collaboration arrangements | |||||
Gain (Loss) recorded due to changes in fair value of derivative asset | $ | $ 800 | ||||
Collaboration Agreement, If 70 Million Is Greater Than Five Percent Of Net Proceeds | Derecognition Of Warrants | |||||
Collaboration arrangements | |||||
Threshold percentage of net proceeds | 5 | ||||
Percentage Of net proceeds payable | 5 | ||||
Collaboration Agreement, If 70 Million Is Lesser Than One Percent Of Net Proceeds | Derecognition Of Warrants | |||||
Collaboration arrangements | |||||
Threshold percentage of net proceeds | 1 | ||||
Percentage Of net proceeds payable | 1 | ||||
Bristol Myers Squibb | uniQure N.V. | First Six New Targets Or Designation Of Sixth Target | BMS Warrants | |||||
Collaboration arrangements | |||||
Ownership percentage required per agreement | 14.90% | ||||
Bristol Myers Squibb | uniQure N.V. | First Six New Targets Or Designation Of Sixth Target | BMS Warrants | Minimum | |||||
Collaboration arrangements | |||||
Number of collaboration targets | 6 | ||||
Bristol Myers Squibb | uniQure N.V. | First Six New Targets Or Designation Of Sixth Target | BMS Warrants | Maximum | |||||
Collaboration arrangements | |||||
Number of collaboration targets | 7 | ||||
Bristol Myers Squibb | uniQure N.V. | First Nine New Targets Or Designation Of Ninth Target | BMS Warrants | |||||
Collaboration arrangements | |||||
Ownership percentage required per agreement | 19.90% | ||||
Bristol Myers Squibb | uniQure N.V. | First Nine New Targets Or Designation Of Ninth Target | BMS Warrants | Minimum | |||||
Collaboration arrangements | |||||
Number of collaboration targets | 9 | ||||
Bristol Myers Squibb | uniQure N.V. | First Nine New Targets Or Designation Of Ninth Target | BMS Warrants | Maximum | |||||
Collaboration arrangements | |||||
Number of collaboration targets | 10 |
Property, plant and equipment_3
Property, plant and equipment, net - Summary of PP&E (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, plant and equipment, net | |||
Total property, plant, and equipment | $ 94,658 | $ 80,405 | |
Less accumulated depreciation | (44,126) | (36,900) | |
Property, plant and equipment, net | 50,532 | 43,505 | |
Depreciation | 8,200 | 6,100 | $ 5,700 |
Leasehold improvements | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | 44,871 | 45,372 | |
Laboratory equipment | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | 39,393 | 25,499 | |
Office equipment | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | 4,985 | 4,465 | |
Construction-in-progress | |||
Property, plant and equipment, net | |||
Total property, plant, and equipment | $ 5,409 | $ 5,069 |
Property, plant and equipment_4
Property, plant and equipment, net - PP&E by geographic region (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Long-lived assets | ||
Long-lived assets | $ 50,532 | $ 43,505 |
Lexington. | ||
Long-lived assets | ||
Long-lived assets | 20,258 | 17,311 |
Amsterdam | ||
Long-lived assets | ||
Long-lived assets | 30,252 | 26,160 |
Other | ||
Long-lived assets | ||
Long-lived assets | $ 22 | $ 34 |
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 | ||||||||
Feb. 28, 2022 ft² item | Dec. 31, 2021 ft² item | Nov. 30, 2018 ft² item | Dec. 31, 2022 USD ($) | Dec. 31, 2022 EUR (€) | May 31, 2021 m² | Dec. 01, 2017 | Jun. 30, 2016 | Mar. 31, 2016 | Nov. 30, 2013 | |
Leases | ||||||||||
Area of facility (in square feet) | 30,655 | 1,080 | ||||||||
Weighted-average remaining lease term, Operating leases | 8 years 3 months 18 days | 7 years 2 months 12 days | 7 years 2 months 12 days | |||||||
Weighted-average discount rate, Operating leases | 11.30% | 11.20% | 11.20% | |||||||
Lexington. | ||||||||||
Leases | ||||||||||
Lease term (in years) | 7 years 4 months | 7 years | 5 years | 10 years | ||||||
Area of facility (in square feet) | ft² | 12,716 | 13,501 | ||||||||
Number of subsequent renewals | item | 1 | 1 | 2 | |||||||
Renewal term (in years) | 5 years | 5 years | 5 years | |||||||
Amsterdam | ||||||||||
Leases | ||||||||||
Lease term (in years) | 10 years | 16 years | ||||||||
Renewal term (in years) | 5 years | |||||||||
Minimum rentals to be received | $ 4.8 | € 4.5 |
Right-of-use asset and lease _4
Right-of-use asset and lease liabilities - Operating lease liabilities (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Dec. 01, 2017 floor | Feb. 29, 2020 floor | Dec. 31, 2022 USD ($) $ / € | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Components of lease cost | |||||
Operating lease cost | $ 5,932 | $ 5,306 | $ 5,052 | ||
Variable lease cost | 785 | 698 | 607 | ||
Sublease income | (849) | (907) | (904) | ||
Total lease cost | 5,868 | 5,097 | 4,755 | ||
Assets | |||||
Operating lease right-of-use assets | 32,726 | 25,573 | |||
Current liabilities | |||||
Current operating lease liabilities | 8,382 | 5,774 | |||
Non-current liabilities | |||||
Non-current operating lease liabilities | 31,719 | 28,987 | |||
Total lease liabilities | 40,101 | 34,761 | |||
Supplemental cash flow information related to leases | |||||
Cash paid for amounts included in the measurement of lease liabilities, Operating cash flows for operating leases | 7,532 | 5,738 | $ 5,769 | ||
Right-of-use asset obtained in exchange for lease obligation | |||||
Operating lease | 9,824 | 1,699 | |||
Undiscounted Cash Flows | |||||
2023 | 8,382 | ||||
2024 | 7,601 | ||||
2025 | 7,956 | ||||
2026 | 8,128 | ||||
2027 | 8,308 | ||||
Thereafter | 17,002 | ||||
Total lease payments | 57,377 | ||||
Less: amount of lease payments representing interest payments | (17,276) | ||||
Total lease liabilities | 40,101 | 34,761 | |||
Less: current operating lease liabilities | (8,382) | (5,774) | |||
Non-current operating lease liabilities | $ 31,719 | $ 28,987 | |||
Exchange rate (in USD per Euro) | $ / € | 1.07 | ||||
Lexington. | |||||
Current liabilities | |||||
Current operating lease liabilities | $ 5,236 | ||||
Non-current liabilities | |||||
Non-current operating lease liabilities | 22,333 | ||||
Total lease liabilities | 27,569 | ||||
Undiscounted Cash Flows | |||||
2023 | 5,236 | ||||
2024 | 5,504 | ||||
2025 | 5,859 | ||||
2026 | 6,031 | ||||
2027 | 6,207 | ||||
Thereafter | 9,343 | ||||
Total lease payments | 38,180 | ||||
Less: amount of lease payments representing interest payments | (10,611) | ||||
Total lease liabilities | 27,569 | ||||
Less: current operating lease liabilities | (5,236) | ||||
Non-current operating lease liabilities | 22,333 | ||||
Amsterdam | |||||
Components of lease cost | |||||
Number of floor of the facility | floor | 7 | ||||
Number of floors to sub-lease | floor | 3 | ||||
Number of floor to take back from the sub-lease | floor | 1 | ||||
Current liabilities | |||||
Current operating lease liabilities | 3,042 | ||||
Non-current liabilities | |||||
Non-current operating lease liabilities | 8,898 | ||||
Total lease liabilities | 11,940 | ||||
Undiscounted Cash Flows | |||||
2023 | 3,042 | ||||
2024 | 1,993 | ||||
2025 | 1,993 | ||||
2026 | 1,993 | ||||
2027 | 1,997 | ||||
Thereafter | 7,190 | ||||
Total lease payments | 18,208 | ||||
Less: amount of lease payments representing interest payments | (6,268) | ||||
Total lease liabilities | 11,940 | ||||
Less: current operating lease liabilities | (3,042) | ||||
Non-current operating lease liabilities | 8,898 | ||||
Other | |||||
Current liabilities | |||||
Current operating lease liabilities | 104 | ||||
Non-current liabilities | |||||
Non-current operating lease liabilities | 488 | ||||
Total lease liabilities | 592 | ||||
Undiscounted Cash Flows | |||||
2023 | 104 | ||||
2024 | 104 | ||||
2025 | 104 | ||||
2026 | 104 | ||||
2027 | 104 | ||||
Thereafter | 469 | ||||
Total lease payments | 989 | ||||
Less: amount of lease payments representing interest payments | (397) | ||||
Total lease liabilities | 592 | ||||
Less: current operating lease liabilities | (104) | ||||
Non-current operating lease liabilities | $ 488 |
Intangible assets, net and Go_3
Intangible assets, net and Goodwill (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite Lived And Indefinite Lived Intangible Assets By Major Class [Line Items] | ||
Acquired licenses, net | $ 58,778 | $ 62,686 |
Intangibles, net | $ 58,778 | $ 62,686 |
Weighted average remaining life | 11 years 6 months | 10 years 9 months 18 days |
Licenses | ||
Finite Lived And Indefinite Lived Intangible Assets By Major Class [Line Items] | ||
Acquired licenses | $ 2,346 | $ 4,755 |
Less accumulated amortization | (900) | (2,827) |
Acquired licenses, net | 1,446 | 1,928 |
In-process research & development | ||
Finite Lived And Indefinite Lived Intangible Assets By Major Class [Line Items] | ||
Acquired IPR&D Intangible Asset | $ 57,332 | $ 60,758 |
Intangible assets - Future amor
Intangible assets - Future amortization expense (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Estimated amortization expense for the next five years | ||
Acquired licenses, net | $ 58,778 | $ 62,686 |
Licenses | ||
Estimated amortization expense for the next five years | ||
2023 | 126 | |
2024 | 126 | |
2025 | 126 | |
2026 | 126 | |
2027 | 126 | |
Thereafter | 816 | |
Acquired licenses, net | $ 1,446 | $ 1,928 |
Intangible assets - Carrying am
Intangible assets - Carrying amount of Licenses (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Intangible assets | |||
Impairment Of Intangible Asset Finite Lived Statement Of Income Or Comprehensive Income Extensible Enumeration Not Disclosed Flag | true | true | true |
Licenses | |||
Intangible assets | |||
Amortization of Intangible Assets | $ 0.4 | $ 1.2 | $ 4.6 |
Impairment expense related to licenses | $ 0 | $ 0 | $ 0.3 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued expenses and other current liabilities | ||
Accruals for goods received from and services provided by vendors-not yet billed | $ 11,120 | $ 13,012 |
Personnel related accruals and liabilities | 17,201 | 12,603 |
Accrued contract fulfillment costs and costs to obtain a contract | 2,250 | 2,872 |
Total | $ 30,571 | $ 28,487 |
Long-term debt (Details)
Long-term debt (Details) - USD ($) $ in Thousands | 12 Months Ended | |||||||
Apr. 01, 2024 | Dec. 15, 2021 | Jan. 29, 2021 | Dec. 06, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | May 31, 2020 | |
Aggregate maturities of loan | ||||||||
Coupon interest payments and financing fees | $ 44,500 | |||||||
2023 | 14,870 | |||||||
2024 | 12,403 | |||||||
2025 | 117,219 | |||||||
Total | 144,492 | |||||||
Prime Rate | ||||||||
Long-term Debt | ||||||||
Variable interest rate basis | 8.25% | |||||||
2016 Amended Facility | Hercules | Second Amended and Restated Loan and Security Agreement [Member] | ||||||||
Long-term Debt | ||||||||
Outstanding debt | $ 20,000 | |||||||
Proceed from drew down | $ 15,000 | |||||||
Interest rate (as a percent) | 8.85% | |||||||
Back-end fees due | $ 1,000 | |||||||
2016 Amended Facility | Prime Rate | Hercules | Second Amended and Restated Loan and Security Agreement [Member] | ||||||||
Long-term Debt | ||||||||
Variable interest rate basis | 8.85% | |||||||
Discount rate (as a percent) | 5.50% | |||||||
2018 Amended Facility | ||||||||
Long-term Debt | ||||||||
Amortized cost net of discount and debt issuance costs | $ 101,600 | |||||||
2021 Amended Facility | ||||||||
Long-term Debt | ||||||||
Outstanding debt | $ 35,000 | |||||||
Proceed from drew down | $ 35,000 | |||||||
Interest rate (as a percent) | 8.25% | |||||||
Maximum borrowing capacity | $ 135,000 | |||||||
Additional unconditional borrowing capacity | $ 100,000 | |||||||
2021 Amended Facility | Minimum | ||||||||
Long-term Debt | ||||||||
Back-end fee (as a percent) | 1.65% | |||||||
2021 Amended Facility | Maximum | ||||||||
Long-term Debt | ||||||||
Back-end fee (as a percent) | 6.85% | |||||||
2021 Amended Facility | Prime Rate | ||||||||
Long-term Debt | ||||||||
Discount rate (as a percent) | 3.25% | |||||||
2018 and 2021 Amended Facility | ||||||||
Long-term Debt | ||||||||
Outstanding debt | $ 70,000 | $ 70,000 | ||||||
Foreign currency loss | 5,800 | $ 3,100 | ||||||
Foreign currency gain | 5,300 | |||||||
Restated Facility 2021 | ||||||||
Long-term Debt | ||||||||
Outstanding debt | 100,000 | 100,000 | ||||||
Proceed from drew down | $ 30,000 | |||||||
Interest rate (as a percent) | 7.95% | |||||||
Back-end fees due | $ 4,850 | 2,500 | ||||||
Amortized cost net of discount and debt issuance costs | 103,800 | |||||||
Restated Facility 2021 | Prime Rate | ||||||||
Long-term Debt | ||||||||
Variable interest rate basis | 7.95% | |||||||
Discount rate (as a percent) | 3.25% | |||||||
Venture debt loan facility | 2018 and 2021 Amended Facility | Hercules | ||||||||
Long-term Debt | ||||||||
Interest expense recorded | $ 11,500 | $ 7,200 | $ 3,700 | |||||
Venture debt loan facility | Restated Facility 2021 | ||||||||
Long-term Debt | ||||||||
Minimum cash and cash equivalents in U.S. bank accounts | 65% | 100% | ||||||
Assets pledged to secure facilities by directly or indirectly | $ 705,000 | |||||||
Assets not being pledged to secure facilities by directly or indirectly | 63,700 | |||||||
Venture debt loan facility | Restated Facility 2021 | Corlieve Therapeutics SAS | ||||||||
Long-term Debt | ||||||||
Assets not being pledged to secure facilities by directly or indirectly | $ 85,200 | |||||||
Subsequent events. | Venture debt loan facility | Restated Facility 2021 | ||||||||
Long-term Debt | ||||||||
Minimum cash and cash equivalents in U.S. bank accounts | 30% |
Shareholder's equity (Details)
Shareholder's equity (Details) € / shares in Units, $ / shares in Units, € in Millions | 2 Months Ended | 12 Months Ended | |||||||
Mar. 01, 2021 USD ($) | Apr. 30, 2021 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / € shares | Dec. 31, 2021 USD ($) | Dec. 31, 2022 EUR (€) € / shares $ / € shares | Dec. 31, 2021 € / shares | Dec. 31, 2021 USD ($) shares | Jun. 16, 2021 shares | Dec. 31, 2020 USD ($) | |
Authorized share capital | $ 4,300,000 | € 4 | |||||||
Common stock, additional shares authorized | shares | 20,000,000 | ||||||||
Exchange rate (in USD per Euro) | $ / € | 1.07 | 1.07 | |||||||
Ordinary shares, authorized | shares | 80,000,000 | 80,000,000 | 80,000,000 | ||||||
Ordinary shares, par value (in euros per share) | € / shares | € 0.05 | € 0.05 | |||||||
Accumulated other comprehensive loss | $ (58,291,000) | $ (28,856,000) | $ (9,900,000) | ||||||
Aggregate offering price | $ 29,564,000 | ||||||||
Income tax benefit of past share issuance cost | 808,000 | 3,047,000 | |||||||
Increase of additional paid in capital | 800,000 | ||||||||
Sales Agreement with SVB Leerink LLC | |||||||||
Percentage of gross proceeds | 3% | ||||||||
Sales Agreement with SVB Leerink LLC | Direct Incremental Labor | |||||||||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 0 | $ 1,300,000 | |||||||
Sales Agreement with SVB Leerink LLC | Ordinary shares | |||||||||
Shares issued in connection with offering | shares | 921,730 | ||||||||
Share price (in dollars per share) | $ / shares | $ 33.52 | ||||||||
Net proceeds | $ 29,600,000 | ||||||||
Sales Agreement with SVB Leerink LLC | Maximum | |||||||||
Aggregate offering price | $ 200,000,000 |
Share-based compensation - Summ
Share-based compensation - Summary of share-based compensation expense and unrecognized costs (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Jun. 30, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based compensation | |||||||
Share-based compensation expense | $ 34,204 | $ 25,635 | $ 21,831 | ||||
Unrecognized compensation costs | $ 49,528 | ||||||
Weighted-average remaining period for recognition (in years) | 2 years 2 months 4 days | ||||||
2014 Plan | |||||||
Share-based compensation | |||||||
Increase in authorized shares | 4,000,000 | 3,000,000 | 3,000,000 | 1,070,000 | |||
Authorized shares | 12,601,471 | ||||||
Employee share purchase plan (ESPP) | |||||||
Share-based compensation | |||||||
Share-based compensation expense | $ 26 | $ 28 | 43 | ||||
Research and development expenses | |||||||
Share-based compensation | |||||||
Share-based compensation expense | 18,402 | 12,834 | 11,995 | ||||
Selling, general and administrative expense | |||||||
Share-based compensation | |||||||
Share-based compensation expense | 15,479 | 12,801 | 9,836 | ||||
Cost of manufacturing services revenues | |||||||
Share-based compensation | |||||||
Share-based compensation expense | 323 | ||||||
Share options | |||||||
Share-based compensation | |||||||
Share-based compensation expense | 13,425 | 12,477 | 11,434 | ||||
Unrecognized compensation costs | $ 24,420 | ||||||
Weighted-average remaining period for recognition (in years) | 2 years 5 months 23 days | ||||||
Restricted share units ("RSUs") | |||||||
Share-based compensation | |||||||
Share-based compensation expense | $ 15,486 | 11,347 | 7,364 | ||||
Unrecognized compensation costs | $ 24,924 | ||||||
Weighted-average remaining period for recognition (in years) | 1 year 10 months 24 days | ||||||
Performance Share Awards | |||||||
Share-based compensation | |||||||
Share-based compensation expense | $ 5,267 | $ 1,783 | $ 2,990 | ||||
Unrecognized compensation costs | $ 184 | ||||||
Weighted-average remaining period for recognition (in years) | 1 month 20 days | ||||||
Employee Stock | Employee share purchase plan (ESPP) | |||||||
Share-based compensation | |||||||
Ordinary shares available for issue | 150,000 | 116,060 | |||||
Discounted rate for purchase of shares | 85% |
Share-based compensation - Opti
Share-based compensation - Option activity and weighted-average assumptions (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Weighted average exercise price | |||
Proceeds from Issuance of Shares under Incentive and Share-based Compensation Plans, Including Stock Options | $ 1,445 | $ 2,798 | $ 7,444 |
2014 Plan | |||
Options | |||
Thereof, outstanding and expected to vest after at end of period (in shares) | 2,098,557 | 1,521,500 | |
Weighted average exercise price | |||
Outstanding and expected to vest after at end of the period (in dollars per share) | $ 13.46 | $ 22.52 | |
Total weighted average grant date fair value of options issued during the period (in $ millions) | $ 12,900 | ||
Proceeds from Issuance of Shares under Incentive and Share-based Compensation Plans, Including Stock Options | $ 1,300 | ||
Vesting period (in years) | 4 years | ||
Weighted-average assumptions used to estimate fair value of share options granted during year | |||
Expected volatility (as a percent) | 70% | 75% | 70% |
Expected terms (in years) | 10 years | 10 years | 10 years |
Risk free interest rate, minimum (as a percent) | 2.12% | 1.21% | 0.76% |
Risk free interest rate, maximum (as a percent) | 4.16% | 1.86% | 1.44% |
Expected dividend (as a percent) | 0% | 0% | 0% |
2014 Plan | Minimum | |||
Weighted-average assumptions used to estimate fair value of share options granted during year | |||
Expected volatility (as a percent) | 70% | ||
2014 Plan | Share options | |||
Options | |||
Outstanding at beginning of the period (in shares) | 3,308,325 | ||
Granted (in shares) | 1,426,966 | 1,174,893 | 653,852 |
Forfeited (in shares) | (204,224) | ||
Expired (in shares) | (154,794) | ||
Exercised (in shares) | (138,356) | (241,496) | (498,678) |
Outstanding at end of the period (in shares) | 4,237,917 | 3,308,325 | |
Thereof, fully vested and exercisable at end of period (in shares) | 2,139,360 | ||
Thereof, outstanding and expected to vest after at end of period (in shares) | 2,098,557 | 1,521,500 | |
Weighted average exercise price | |||
Outstanding at beginning of the period (in dollars per share) | $ 31.02 | ||
Granted (in dollars per share) | 15.90 | ||
Forfeited (in dollars per share) | 38.29 | ||
Expired (in dollars per share) | 36.86 | ||
Exercised (in dollars per share) | 7.81 | ||
Outstanding at end of period (in dollars per share) | 26.13 | $ 31.02 | |
Thereof, fully vested and exercisable at end of period (in dollars per share) | 28.82 | ||
Outstanding and expected to vest after at end of the period (in dollars per share) | $ 23.38 | $ 38.71 | |
Weighted average remaining contractual life (in years) | |||
Outstanding | 7 years 1 month 20 days | 7 years 18 days | |
Thereof, fully vested and exercisable at end of year | 5 years 5 months 12 days | ||
Outstanding and expected to vest at end of year | 8 years 10 months 9 days | ||
Aggregate intrinsic value | |||
Outstanding (in dollars) | $ 17,848 | $ 8,660 | |
Thereof, fully vested and exercisable | 8,339 | ||
Outstanding and expected to vest | 9,509 | ||
Exercised (in dollars) | $ 1,848 | $ 5,046 | $ 11,927 |
Weighted average grant-date fair value | |||
Vested (in shares) | 652,635 | ||
Forfeited (in dollar per share) | $ 22.17 | ||
2014 Plan | Non-executive directors | |||
Weighted average exercise price | |||
Vesting period (in years) | 1 year | ||
2014 Plan | Directors and Officers | |||
Options | |||
Granted (in shares) | 672,908 | ||
Weighted average exercise price | |||
Granted (in dollars per share) | $ 5.9 | ||
2014 Plan | One year from grant date | |||
Weighted average exercise price | |||
Vesting percentage per year | 25% | ||
Vesting period (in years) | 1 year | ||
2012 Plan | |||
Options | |||
Outstanding at beginning of the period (in shares) | 14,000 | ||
Outstanding at end of the period (in shares) | 0 | 14,000 |
Share-based compensation - RSU
Share-based compensation - RSU activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
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 period (in shares) | 710,617 | ||
Granted (in shares) | 1,604,533 | ||
Vested (in shares) | (292,688) | ||
Forfeited (in shares) | (203,688) | ||
Non-vested at end of period (in shares) | 1,818,774 | 710,617 | |
Weighted average grant-date fair value | |||
Non-vested at beginning of period (in dollars per share) | $ 38.89 | ||
Granted (in dollars per share) | 16.10 | ||
Vested (in dollars per share) | 39.31 | ||
Forfeited (in dollars per share) | 23.39 | ||
Non-vested at end of period (in dollars per share) | $ 20.46 | $ 38.89 | |
Other disclosure | |||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 25,800 | ||
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 | |||
Granted (in shares) | 380,288 | ||
Weighted average grant-date fair value | |||
Granted (in dollars per share) | $ 6 | ||
Restricted share units ("RSUs") | 2014 Plan | |||
Number of shares | |||
Granted (in shares) | 1,604,533 | 574,921 | 376,799 |
Weighted average grant-date fair value | |||
Granted (in dollars per share) | $ 16.10 | $ 36.14 | $ 48.18 |
Other disclosure | |||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ 5,104 | $ 8,063 | $ 12,156 |
Share options | 2014 Plan | |||
Weighted average grant-date fair value | |||
Granted (in dollars per share) | $ 9.04 | $ 20.95 | $ 28.08 |
Vested (in dollars per share) | $ 22.27 | ||
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) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Dec. 31, 2022 USD ($) Milestone $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2020 USD ($) $ / shares shares | |
Other disclosure | ||||
Service period | 1 year | 3 years | ||
Performance Share Awards | ||||
Number of shares | ||||
Non-vested at beginning of period (in shares) | shares | 632,930 | |||
Granted (in shares) | shares | 34,700 | |||
Vested (in shares) | shares | (213,145) | |||
Forfeited (in shares) | shares | (53,795) | |||
Non-vested at end of period (in shares) | shares | 400,690 | 632,930 | ||
Weighted average grant-date fair value | ||||
Non-vested at beginning of period (in dollars per share) | $ 33.54 | |||
Granted (in dollars per share) | 15.11 | |||
Vested (in dollars per share) | 40.46 | |||
Forfeited (in dollars per share) | 29.35 | |||
Non-vested at end of period (in dollars per share) | $ 28.82 | $ 33.54 | ||
Other disclosure | ||||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ | $ 500 | |||
Number of Milestones Achieved | Milestone | 1 | |||
Number of Defined Milestones | Milestone | 5 | |||
Number of Milestones Achievement Considered Probable | Milestone | 1 | |||
Performance Share Awards | 2014 Plan | ||||
Number of shares | ||||
Granted (in shares) | shares | 34,700 | 555,600 | 91,003 | |
Weighted average grant-date fair value | ||||
Granted (in dollars per share) | $ 15.11 | $ 30.19 | $ 57.56 | |
Other disclosure | ||||
Total weighted average grant date fair value of RSUs granted during the period (in millions) | $ | $ 4,450 | $ 5,074 | $ 21,852 | |
Share options | 2014 Plan | ||||
Weighted average grant-date fair value | ||||
Granted (in dollars per share) | $ 9.04 | $ 20.95 | $ 28.08 | |
Vested (in dollars per share) | $ 22.27 |
Share-based compensation - Empl
Share-based compensation - Employee Share Purchase Plan (Details) - Employee share purchase plan (ESPP) - Employee Stock - shares | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2018 | |
Share-based compensation | ||||
Number of shares issued | 11,242 | 4,724 | 6,181 | |
Ordinary shares available for issue | 116,060 | 150,000 |
Expenses by nature - Operating
Expenses by nature - Operating expenses excluding expenses presented in other expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating expenses: | |||
Employee-related expenses | $ 119,903 | $ 96,161 | $ 75,926 |
Laboratory and development expenses | 65,964 | 36,014 | 35,977 |
Office and housing expenses | 17,612 | 14,638 | 13,388 |
Legal and advisory expenses | 15,782 | 24,767 | 17,370 |
Other operating expenses | 8,510 | 10,528 | 8,772 |
Patent and license expenses | 9,548 | 3,748 | 2,899 |
Depreciation and amortization expenses | 8,250 | 7,299 | 10,648 |
Fair value loss - Corlieve contingent consideration | 7,081 | 6,683 | |
Total | $ 252,650 | $ 199,838 | $ 164,980 |
Expenses by nature - Employee-r
Expenses by nature - Employee-related expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Employee-related expenses | |||
Wages and salaries | $ 63,704 | $ 53,078 | $ 40,919 |
Share-based compensation expenses | 33,881 | 25,635 | 21,831 |
Social security costs | 5,179 | 4,496 | 4,068 |
Health insurance | 4,148 | 3,161 | 2,271 |
Contractor expenses | 3,959 | 3,170 | 2,423 |
Other employee expenses | 6,365 | 4,570 | 2,635 |
Pension costs - defined contribution plans | 2,667 | 2,051 | 1,779 |
Total | $ 119,903 | $ 96,161 | $ 75,926 |
Other income (Details)
Other income (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Equity Method Investments [Line Items] | |||
Other Income | $ 7,171 | $ 12,306 | $ 3,342 |
Income from payments received from European authorities | 5,600 | 5,300 | 1,900 |
Employee retention income | 0 | 2,600 | $ 0 |
VectorY B.V | |||
Schedule of Equity Method Investments [Line Items] | |||
Settlement Income | $ 300 | $ 3,000 | |
Number of shares acquired in conjunction with settlement agreement | 69,899 |
Income taxes - Income (loss) be
Income taxes - Income (loss) before income tax (expense) benefit (Details) $ in Thousands, € in Millions | 12 Months Ended | ||||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Jul. 30, 2021 USD ($) | Jul. 30, 2021 EUR (€) | |
Loss before income taxes | |||||
Unrecognized Tax Benefits | $ 0 | $ 0 | |||
Dutch operations | (96,872) | 348,400 | $ (130,493) | ||
(Loss) / income before income tax benefit / (expense) | (128,259) | 332,806 | (141,443) | ||
Current tax expense | |||||
Total current tax (expense) | (24) | (7) | |||
Deferred tax benefit / (expense) | |||||
Dutch operations | (808) | (3,047) | |||
Total deferred tax benefit / (expense) | 1,494 | (3,210) | 16,419 | ||
Total income tax benefit / (expense) | 1,470 | (3,217) | 16,419 | ||
Acquisition of Corlieve | |||||
Loss before income taxes | |||||
Deferred tax liability, net | $ 14,200 | € 11.9 | |||
U.S. operations | |||||
Loss before income taxes | |||||
Loss before income tax benefit / (expense) | (14,934) | (12,737) | (10,950) | ||
Deferred tax benefit / (expense) | |||||
Deferred tax benefit / (expense) | (1,075) | (771) | $ 16,419 | ||
Other | |||||
Loss before income taxes | |||||
Loss before income tax benefit / (expense) | (16,453) | (2,857) | |||
Current tax expense | |||||
Current tax (expense) | (24) | (7) | |||
Deferred tax benefit / (expense) | |||||
Deferred tax benefit / (expense) | $ 3,377 | $ 608 |
Income taxes - Tax rate reconci
Income taxes - Tax rate reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Tax rate reconciliation | |||
(Loss) / income before income tax benefit / (expense) for the period | $ (128,259) | $ 332,806 | $ (141,443) |
Expected income tax benefit / (expense) at the tax rate enacted in the Netherlands (2022: 25.8%, 2021: 25.0%, 2020: 25.0%) | 33,091 | (83,201) | 35,361 |
Non-deductible expenses | (11,129) | (9,182) | (5,041) |
Other net change in valuation allowance | (20,591) | 88,857 | (30,568) |
Difference in tax rates between the Netherlands and the U.S. as well as other foreign countries | 99 | 309 | 247 |
Release of valuation allowance related to expected future taxable income of U.S. operations | (20,593) | 88,858 | (30,568) |
Total income tax benefit / (expense) | $ 1,470 | $ (3,217) | $ 16,419 |
Enacted tax rate | 25.80% | 25% | 25% |
Non-deductible expenses, Share-based compensation | $ 8,500 | $ 6,700 | $ 5,800 |
Fair value loss on contingent consideration | $ 1,900 | $ 2,000 | 0 |
U.S. operations | |||
Tax rate reconciliation | |||
Release of valuation allowance related to expected future taxable income of U.S. operations | $ 16,419 | ||
Enacted tax rate | 21% |
Income taxes - Significant comp
Income taxes - Significant components of deferred taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||||
Net operating loss carryforwards | $ 84,633 | $ 71,917 | ||
Operating lease liabilities | 10,612 | 9,300 | ||
Intangible assets | 3,826 | 2,039 | ||
Accrued expenses and other current liabilities | 1,862 | 1,312 | ||
Property, plant and equipment | 510 | 971 | ||
Inventory | 148 | |||
Research and development tax credit carryforwards | 144 | 105 | ||
Interest carryforwards | 3,697 | |||
Total deferred tax assets | 105,284 | 85,792 | ||
Less valuation allowance | (74,547) | (60,289) | $ (150,113) | $ (109,856) |
Deferred tax assets, net of valuation allowance | 30,737 | 25,503 | ||
Deferred tax liabilities: | ||||
Acquired IPR&D Intangible Asset (see Note 3, "Corlieve transaction") | (15,033) | (15,189) | ||
Operating lease right-of-use assets | (9,323) | (7,493) | ||
Other current assets and receivables | (110) | (87) | ||
Deferred tax liability | (24,466) | (22,769) | ||
Net deferred tax asset | $ 6,271 | $ 2,734 |
Income taxes - Changes in valua
Income taxes - Changes in valuation allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Opening balance | $ 60,289 | $ 150,113 | $ 109,856 |
Changes recorded in the statement of operations | 20,593 | (88,858) | 30,568 |
Changes recorded in equity | (972) | ||
Increase related to 2021 and 2020 Dutch tax reforms | 1,897 | 18,287 | |
Valuation allowance assumed in Corlieve acquisition | 545 | ||
Other changes including currency translation adjustments | (5,363) | (3,408) | 7,821 |
Ending balance | 74,547 | 60,289 | 150,113 |
Amount of valuation allowance for deferred tax assets within contributed capital as it relates to follow on offering costs. | $ 3,300 | $ 4,500 | |
U.S. operations | |||
Changes recorded in the statement of operations | (16,419) | ||
Release of valuation allowance related to expected current year and future periods recorded in profit and loss | $ (16,419) |
Income taxes - Effective Tax Ra
Income taxes - Effective Tax Rate (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Jul. 30, 2021 | May 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Net operating loss carryforwards utilization | $ 1,200 | ||||
Enacted tax rate | 25.80% | 25% | 25% | ||
Deferred tax (benefit) expense | $ (1,494) | $ 3,210 | $ (16,419) | ||
Income tax benefit of past share issuance cost | 808 | 3,047 | |||
Revenue | 106,483 | 524,002 | 37,514 | ||
License revenues | |||||
Revenue | $ 462,400 | $ 100,000 | $ 517,400 | $ 4,352 | |
U.S. operations | |||||
Effective income tax rate | 27.32% | ||||
Enacted tax rate | 21% | ||||
France | |||||
Effective income tax rate | 25% | ||||
Operating Loss Carryforwards, Not Subject to Expiration | $ 23,300 | ||||
Percentage of corporate tax rate | 3.30% | ||||
Effective income tax rate continuing operations | 25.80% | ||||
CSL Behring collaboration. | |||||
Revenue | $ 100,000 | ||||
Acquisition of Corlieve | |||||
Enacted tax rate | 25% |
Income taxes - Tax losses expir
Income taxes - Tax losses expiring (Details) - USD ($) $ in Millions | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Tax loss carry-forwards | |||
Tax loss carry-forwards | $ 264 | $ 228.5 | $ 588.2 |
U.S. operations | 2021 | |||
Tax loss carry-forwards | |||
Tax loss carry-forwards | $ 38.5 |
Basic and diluted earnings pe_3
Basic and diluted earnings per share - Ordinary share (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Net (loss) / income attributable to ordinary shares | $ (126,789) | $ 329,589 | $ (125,024) |
Weighted-average number of ordinary shares outstanding - basic | 46,735,045 | 45,986,467 | 44,466,365 |
Weighted-average number of ordinary shares outstanding - diluted | 46,735,045 | 46,840,972 | 44,466,365 |
Employee share purchase plan (ESPP) | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based payment arrangements | 1,299 | ||
Stock options | Previous plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based payment arrangements | 746,044 | ||
Non-vested RSUs and PSUs | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based payment arrangements | 107,162 |
Basic and diluted earnings pe_4
Basic and diluted earnings per share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 6,458,429 | 3,814,508 | 3,353,797 |
Employee share purchase plan (ESPP) | |||
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 1,048 | 1,842 | 560 |
Stock options | |||
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 4,237,917 | 2,576,281 | 2,673,279 |
Non-vested RSUs and PSUs | |||
Basic and diluted earnings per share | |||
Total potential dilutive ordinary shares | 2,219,464 | 1,236,385 | 679,958 |
Subsequent events (Details)
Subsequent events (Details) - Subsequent events. $ in Millions | Jan. 13, 2023 USD ($) |
Global licensing agreement | |
Subsequent events | |
Initial cash payment | $ 10 |
Regulatory approvals in the U.S. and Europe | |
Subsequent events | |
Maximum amount of milestone payments payable | $ 43 |