29 unchanged sentences
During the three months ended December 31, 2024, none of our directors or officers informed us of the adoption , modification or termination of a “ Rule 10b5-1 trading arrangement ” or “ non-Rule 10b5-1 trading arrangement ,” as each term is defined in Item 408(a) of Regulation S-K.
−Removed: Amendments to Code of Ethics
−Removed: On February 27, 2024, our Board approved certain amendments to our Code of Business Conduct and Ethics (as amended, the “Code”) upon the recommendation of the Audit Committee of the Board.
−Removed: The Code was approved and adopted by the Board as part of its ordinary course and recurring review of our corporate codes and policies and applies to our employees, directors and officers.
−Removed: The amendments to the Code did not relate to or result in any waiver, explicit or implicit, of any provision of the Code in effect prior to the amendment.
−Removed: The amendments to the Code update, clarify and, in certain cases, enhance provisions of the Code including, but not limited to, the reporting of actual or possible violations of the Code, the scope of matters that are reportable under the Code, the scope of the Audit Committee’s oversight regarding concerns and complaints involving allegations of fraud or violations of applicable law or regulation, and enforcement and compliance procedures with respect to alleged violations of the Code.
−Removed: The above description of the Code does not purport to be complete and is qualified in its entirety by reference to the full text of the Code, a copy of which is filed as Exhibit 14.1 to this Annual Report on Form 10-K and available on the Investors & Media subpage of our website at www.uniqure.com under the “Corporate Governance” link.
−Removed: Information on our website shall not be deemed incorporated by reference into, or to be a part of, this Annual Report on Form 10-K.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Directors, Executive Officers and Corporate Governance
−Removed: The information required by this item is incorporated by reference from our Proxy Statement for our 2024 annual meeting of shareholders, which we will file within 120 days of December 31, 2023, or will be included in an amendment to this Annual Report on Form 10-K.
+Added: We maintain an insider trading policy governing the purchase, sale and/or other dispositions of our securities by our directors, officers, employees, consultants and contractors, as well as the Company itself.
+Added: We believe that the insider trading policy is reasonably designed to promote compliance with insider trading laws, rules and regulations, as well as the applicable laws and regulations of the Nasdaq listing standards.
+Added: A copy of our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
+Added: The remaining information required by Item 10 is incorporated by reference from our Proxy Statement for our 2025 annual meeting of shareholders, which we will file within 120 days of December 31, 2024, or will be included in an amendment to this Annual Report on Form 10-K.
Executive Compensation
14 unchanged sentences
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2024, 2023 and 2022
−Removed: Consolidated Statements of Shareholders’ Equity for the Years Ended December 31, 2023, 2022 and 2021
+Added: Consolidated Statements of Shareholders’ (Deficit) / Equity for the Years Ended December 31, 2024, 2023 and 2022
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024, 2023 and 2022
12 unchanged sentences
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2024, 2023 and 2022
−Removed: Consolidated Statements of Shareholders’ Equity for the Years Ended December 31, 2023, 2022 and 2021
+Added: Consolidated Statements of Shareholders’ (Deficit) / Equity for the Years Ended December 31, 2024, 2023 and 2022
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024, 2023 and 2022
5 unchanged sentences
We have audited the accompanying consolidated balance sheets of uniQure N.V.
−Removed: and subsidiaries (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, shareholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2023, and the related notes (collectively, the consolidated financial statements).
+Added: and subsidiaries (‘the Company’) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, shareholders’ (deficit) / equity, and cash flows for each of the years in the three-year period ended December 31, 2024, and the related notes (collectively, the consolidated financial statements).
We also have audited the Company’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
23 unchanged sentences
Critical Audit Matters
−Removed: Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the consolidated f inancial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: We determined that there are no critical audit matters.
+Added: The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Valuation of intangible asset at initial recognition arising from favorable terms in the Commercial Supply Agreement
+Added: As described in Notes 3 and 6 to the consolidated financial statements, the Company recorded an intangible asset valued at $16.7 million derived from the consideration received following the sale of the Lexington facility and based on the Commercial Supply Agreement entered into with Genezen.
+Added: This intangible asset represents the rights to purchase HEMGENIX® at terms considered favorable to market terms.
+Added: The valuation at initial recognition is based on the difference between the contractually agreed price under the Commercial Supply Agreement and the estimated commercial supply price for purchases to be made under the agreement.
+Added: We identified the valuation of the intangible asset at initial recognition arising from favorable terms in the Commercial Supply Agreement as a critical audit matter.
+Added: We performed a sensitivity analysis to identify the significant assumptions used to value the intangible asset, individually and in the aggregate, and determined this assumption to be the commercial supply price.
+Added: Minor changes in this assumption could have a significant impact on the valuation of the intangible asset at initial recognition A high degree of subjective auditor judgement was required to evaluate the commercial supply price assumption for the goods supplied under the agreement, due to the lack of direct observable commercial supply prices.
+Added: The following are the primary procedures we performed to address this critical audit matter:
+Added: • We evaluated the design and tested the operating effectiveness of certain internal controls related to the valuation of the intangible asset.
+Added: • We evaluated management’s methodology for determining the commercial supply price in the absence of comparable agreements, by comparing management’s estimate of commercial supply price to contracts in place with other suppliers and to the Company’s historical production costs to assess the reasonableness of management’s commercial supply price assumption.
/s/ KPMG Accountants N.V.
7 unchanged sentences
Current investment securities
−Removed: Accounts receivable and contract asset
+Added: Accounts receivable
Inventories, net
4 unchanged sentences
Property, plant and equipment, net
−Removed: Non-current investment securities
+Added: Other investments
Operating lease right-of-use assets
15 unchanged sentences
Deferred tax liability, net
−Removed: Other non-current liabilities
+Added: Other non-current liabilities, net of current portion
Total non-current liabilities
1 unchanged sentence
Commitments and contingencies
−Removed: Shareholders' equity
+Added: Shareholders' (deficit) / equity
Ordinary shares, € 0.05 par value:
3 unchanged sentences
Accumulated deficit
−Removed: Total shareholders' equity
−Removed: Total liabilities and shareholders' equity
+Added: ( 1,129,965 )
+Added: Total shareholders' (deficit) / equity
+Added: Total liabilities and shareholders' (deficit) / equity
The accompanying notes are an integral part of these consolidated financial statements.
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS AND INCOME
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Year ended December 31,
11 unchanged sentences
Other expense
−Removed: (Loss) / income from operations
+Added: Loss from operations
Interest income
1 unchanged sentence
Foreign currency (losses) / gains, net
−Removed: Other non-operating gains / (losses), net
−Removed: (Loss) / income before income tax (expense) / benefit
+Added: Other non-operating gains, net
+Added: Loss before income tax (expense) / benefit
Income tax (expense) / benefit
−Removed: Net (loss) / income
Other comprehensive income / (loss):
−Removed: Foreign currency translation gains / (losses), net
−Removed: Defined benefit pension loss, net of taxes
−Removed: Total comprehensive (loss) / income
−Removed: Earnings per ordinary share - basic
−Removed: Basic net (loss) / income per ordinary share
−Removed: Earnings per ordinary share - diluted
−Removed: Diluted net (loss) / income per ordinary share
−Removed: Weighted average shares - basic
−Removed: Weighted average shares - diluted
+Added: Foreign currency translation gain / (losses), net
+Added: Defined benefit pension gain / (loss), net of taxes
+Added: Total comprehensive loss
+Added: Earnings per ordinary share - basic and diluted
+Added: Basic and diluted net loss per ordinary share
+Added: Weighted average shares - basic and diluted
The accompanying notes are an integral part of these consolidated financial statements.
−Removed: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
+Added: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ (DEFICIT) / EQUITY
Ordinary shares
1 unchanged sentence
shareholders’
−Removed: income / (loss)
+Added: (deficit) / equity
(in thousands, except share and per share amounts)
Balance at December 31, 2021
−Removed: Income for the period
+Added: Loss for the period
Other comprehensive loss
−Removed: Issuance of ordinary shares
Income tax benefit of past share issuance cost
5 unchanged sentences
Loss for the period
−Removed: Other comprehensive loss
−Removed: Income tax benefit of past share issuance cost
+Added: Other comprehensive income, net
Exercises of share options
10 unchanged sentences
Balance at December 31, 2024
+Added: ( 1,129,965 )
The accompanying notes are an integral part of these consolidated financial statements
3 unchanged sentences
Cash flows from operating activities
−Removed: Net (loss) / income
−Removed: Adjustments to reconcile net (loss) / income to net cash (used in) / generated from operating activities:
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation, amortization and impairment
−Removed: Amortization of premium/discount on investment securities
+Added: Amortization of discount on investment securities
Share-based compensation expense
−Removed: Royalty financing agreement interest expense
+Added: Royalty financing agreement interest expense, net of interest paid
Deferred tax expense / (income)
Changes in fair value of contingent consideration and derivative financial instrument, net
−Removed: Unrealized foreign exchange gains, net
+Added: Unrealized foreign exchange losses / (gains), net
Other items, net
5 unchanged sentences
Contingent consideration milestone payment
−Removed: Net cash (used in) / generated from operating activities
+Added: Net cash used in operating activities
Cash flows from investing activities
−Removed: Investment in debt securities
Proceeds on maturity of debt securities
+Added: Investment in debt securities
+Added: Divestment of commercial manufacturing facility
Purchases of property, plant, and equipment
Acquisition of uniQure France SAS, net of cash acquired
−Removed: Net cash used in investing activities
+Added: Net cash generated from / (used in) investing activities
Cash flows from financing activities
−Removed: Proceeds from issuance of ordinary shares
−Removed: Share issuance costs from issuance of ordinary shares
Proceeds from royalty financing agreement
Payment of debt issuance costs
−Removed: Repayment of debt acquired through acquisition of uniQure France SAS
−Removed: Proceeds from loan increment, net of debt issuance costs
Proceeds from issuance of ordinary shares related to employee stock option and purchase plans
+Added: Repayment of long-term debt
Contingent consideration milestone payment
−Removed: Net cash generated from financing activities
+Added: Net cash (used in) / generated from financing activities
Currency effect on cash, cash equivalents and restricted cash
−Removed: Net increase / (decrease) in cash, cash equivalents and restricted cash
+Added: Net (decrease) / increase in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash at beginning of period
8 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: General business information
−Removed: uniQure (the “Company”) was incorporated on January 9, 2012 as a private company with limited liability ( besloten vennootschap met beperkte aansprakelijkheid ) under the laws of the Netherlands.
+Added: Corporate information
+Added: (the “Company”) was incorporated on January 9, 2012 as a private company with limited liability ( besloten vennootschap met beperkte aansprakelijkheid ) under the laws of the Netherlands.
The Company is a leader in the field of gene therapy and seeks to deliver to patients suffering from rare and other devastating diseases single treatments with potentially curative results.
22 unchanged sentences
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.
−Removed: Estimates and assumptions are primarily made in relation to contingent consideration related to the acquisition of uniQure France SAS, 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.
+Added: Estimates and assumptions are primarily made in relation to contingent consideration related to the acquisition of uniQure France SAS, the valuation of the intangible asset with favorable terms recorded as part of the sale the Company’s commercial manufacturing activities located in Lexington, MA (“Lexington Transaction”) in July 2024 and the date at which the Company expects to satisfy its commitment under the Royalty Financing Agreement (refer to definition in Note 2.3.27).
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.
5 unchanged sentences
Subsidiaries are all entities over which the Company has a controlling financial interest either through variable interest or through voting interest.
−Removed: Currently, the Company has no involvement with variable interest entities.
+Added: Currently, the Company is not involved with variable interest entities.
Inter-company transactions, balances, income, and expenses on transactions between uniQure entities are eliminated in consolidation.
39 unchanged sentences
The carrying amount of cash and cash equivalents, accounts receivable from licensing and collaboration partners, 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.
−Removed: 2.3.5 uniQure France SAS transaction
−Removed: On June 21, 2021, we entered into a share and purchase agreement (“SPA”) to acquire all of the outstanding ordinary shares of uniQure France SAS (formerly Corlieve Therapeutics SAS), a privately held French gene therapy company (“uniQure France SAS Transaction”).
−Removed: On July 30, 2021 (“Acquisition Date”), the Company acquired uniQure France SAS.
−Removed: The Company evaluated the uniQure France SAS transaction as to whether or not the transaction should be accounted for as a business combination or asset acquisition.
−Removed: Refer to Note 3 “ uniQure France SAS transaction ” for further detail.
−Removed: 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.
−Removed: Goodwill is not amortized but is evaluated 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 more likely than not reduce the fair value of the reporting unit below its carrying amount.
−Removed: As of December 31, 2023, 2022 and 2021, the Company has not recognized any impairment charges related to goodwill.
−Removed: Refer to Note 3 “ uniQure France SAS transaction ” for further detail.
−Removed: Acquired research and development
−Removed: 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 uniQure France SAS in 2019 constitute an In-process research and development intangible asset (“IPR&D Intangible Asset”).
−Removed: 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.
−Removed: 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.
−Removed: For the years ended December 31, 2023, 2022 and 2021, the Company has not recognized any impairment charges related to the IPR&D Intangible Asset.
−Removed: In case of abandonment, the IPR&D Intangible Asset will be written-off.
−Removed: 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.
−Removed: Refer to Note 3 “ uniQure France SAS transaction ” for further detail.
2.3.5 Contingent consideration
−Removed: Each reporting period, the Company revalues the contingent consideration obligations associated with the uniQure France SAS transaction to their fair value and records changes in the fair value within research and development expenses.
−Removed: Changes in contingent consideration obligations 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.
+Added: Each reporting period, the Company revalues the contingent consideration obligations associated with the acquisition of uniQure France SAS in 2021 to their fair value and records changes in the fair value within research and development expenses.
+Added: Changes in contingent consideration obligations result from changes in assumptions regarding the probabilities of achieving the relevant milestones, the estimated timing of achieving such milestones, and the interest rate to discount the milestone payments.
+Added: The probability-adjusted payments are discounted to present value using a discount rate representing the Company’s credit risk.
+Added: This discount rate is determined using the effective interest rate of the Company’s existing debt facility adjusted for difference in maturity dates based on market data on effective yields for U.S.
+Added: bonds with a CCC credit rating.
Payments of portions of contingent consideration initially recorded as of the acquisition date are recorded as cash flows from financing activities, and payments, or the portion of the milestone payments representing changes in the fair value of contingent consideration subsequent to the initial recognition, are recorded as cash flows from operating activities.
−Removed: Refer to Note 3 “ uniQure France SAS transaction ” for further detail.
+Added: Refer to Note 7 “ Fair value measurement ” for further information.
+Added: 2.3.6 Divestiture of commercial manufacturing activities
+Added: On June 29, 2024, affiliates of the Company entered into an Asset Purchase Agreement (“APA”) with Genezen Holdings Inc.
+Added: and its affiliate Genezen MA, Inc.
+Added: (together “Genezen”).
+Added: Pursuant to the APA, the Company sold its commercial manufacturing activities located in Lexington, MA (the “Lexington Transaction”) to Genezen.
+Added: The Lexington Transaction closed on July 22, 2024 (the “Closing”).
+Added: The Lexington Transaction was accounted for as a divestment of the Company’s commercial manufacturing activities in accordance with ASC 805, Business Combinations .
+Added: As consideration, the Company received (i) shares of newly issued Series C preferred stock of Genezen Holdings Inc.
+Added: which are convertible into Genezen common stock and will accrue an 8.0 % per annum cumulative dividend, (ii) a convertible promissory note with a nominal amount of $ 12.5 million, bearing interest at 8.0 % per annum and maturing 63 months following the date of issuance, (iii) a right to purchase HEMGENIX® at terms considered favorable to market terms and (iv) a firm purchase commitment liability for its customer contract with CSL Behring inherently related to the right to purchase HEMGENIX®.
+Added: Refer to Note 3 “ Divestiture of commercial manufacturing activities” for further detail.
+Added: Series C preferred stock
+Added: The Company recorded the Series C preferred stock in Genezen Holdings Inc.
+Added: issued to the Company at its fair value.
+Added: The Company subsequently measures these non-marketable equity securities at cost less any impairment, adjusted to fair value if there are observable price changes in orderly transactions for an identical or similar investment of the Genezen Holdings Inc., in accordance with topic ASC 321, Investments – Equity Securities.
+Added: The series C preferred stock is presented within Other investments on the consolidated balance sheets.
+Added: Convertible promissory note
+Added: The convertible promissory note was recognized at its fair value.
+Added: The convertible promissory note is classified as not held for sale and subsequently measured at amortized cost, net of allowance for credit losses in accordance with topic ASC 310, Receivables as it did not meet the definition of a debt security under topic ASC 320 , Investments – Debt Securities.
+Added: The Company accrues interest income on its convertible promissory note using the effective interest method over the convertible promissory note’s contractual term.
+Added: The convertible promissory note is presented within Other investments on the consolidated balance sheets.
+Added: Right to purchase
+Added: The Company entered into a Commercial Supply Agreement (“CSA”) with Genezen.
+Added: The CSA provides the Company with rights to purchase HEMGENIX® at terms considered favorable to market terms.
+Added: In accordance with ASC 805, Business Combinations, the Company recorded an intangible asset at its fair value with respect to these favorable terms at Closing.
+Added: The intangible asset is stated at historical cost less accumulated amortization.
+Added: The Company amortizes the intangible asset on a straight-line basis over a three-year term.
+Added: The Company presents the amortization expense within Other expense in the Consolidated Statement of Operations and Comprehensive Loss.
+Added: Firm purchase commitment liability
+Added: The CSA includes a minimum term of three years and minimum purchase commitments of HEMGENIX® over the first three years, unless certain contractual provisions are triggered.
+Added: The Company expects to resell HEMGENIX® purchased from Genezen via its minimum commitments to CSL Behring at a loss.
+Added: In accordance with ASC 330, Inventory, the Company recognized a liability related to the net losses expected from the purchase of these minimum commitments.
+Added: The Company presents the current portion of the firm purchase commitment liability within accrued expenses and other current liabilities and the non-current portion within other non-current liabilities on the consolidated balance sheets.
+Added: The Company subsequently adjusts the liability for any changes to the losses expected to be incurred.
+Added: The Company presents changes to the liability within other expenses.
2.3.7 Notes to the consolidated statements of cash flows
6 unchanged sentences
2.3.8 Segment information
−Removed: 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.
−Removed: The Company views its operations and manages its business as one operating segment, which comprises the discovery, development, and commercialization of innovative gene therapies.
−Removed: 2.3.8 Net (loss) / income per share
+Added: 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 (“CODM”), or decision-making group, in making decisions on how to allocate resources and assess performance.
+Added: The Company views its operations and manages its business as one operating segment, which comprises the discovery and development of innovative gene therapies.
+Added: 2.3.9 Net loss per ordinary share
The Company follows the provisions of ASC 260 , Earnings Per Share .
−Removed: In accordance with these provisions, net (loss) / income per share is calculated by dividing net (loss) / income by the weighted average number of ordinary shares outstanding during the period.
−Removed: 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.
+Added: In accordance with these provisions, net loss per ordinary share is calculated by dividing net (loss) / income by the weighted average number of ordinary shares outstanding during the period.
+Added: Diluted net loss per ordinary 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.
4 unchanged sentences
The recoverability of the carrying value of an asset or asset group depends on the successful execution of the Company’s business initiatives and its ability to earn sufficient returns on approved products and product candidates.
−Removed: When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows.
+Added: When events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows.
If the future undiscounted cash flows are less than the carrying amount of these assets, the Company recognizes an impairment loss based on the excess of the carrying value over the fair value of the assets.
Fair value is determined through various valuation techniques, including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary.
−Removed: Refer to Note 2.3.5 “ uniQure France SAS transaction ” for information on impairment testing related to goodwill and acquired research and development intangible assets.
+Added: 2.3.11 Goodwill and acquired research and development intangible asset
+Added: 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.
+Added: Goodwill is not amortized but is evaluated 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 more likely than not reduce the fair value of the reporting unit below its carrying amount.
+Added: A reporting unit is an operating segment or one level below an operating segment.
+Added: In the years ended December 31, 2024, 2023 and 2022, the Company has not recognized any impairment charges related to goodwill.
+Added: Acquired research and development
+Added: As part of the acquisition of uniQure France SAS in 2021 the Company recorded an In-process research and development intangible asset related to the AMT-260 program (“IPR&D Intangible Asset”).
+Added: 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.
+Added: If and when development is completed, which would occur when regulatory approval to market a candidate for the treatment of temporal lobe epilepsy 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.
+Added: For the years ended December 31, 2024, 2023 and 2022, the Company has not recognized any impairment charges related to the IPR&D Intangible Asset.
+Added: In case of abandonment, the IPR&D Intangible Asset will be written-off.
+Added: 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.
2.3.12 Investment securities
4 unchanged sentences
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.
−Removed: Investments securities with original maturities of less than three months when purchased are presented within cash and cash equivalents (December 31, 2023:
−Removed: nil , December 31, 2022:
−Removed: $ 21.2 million).
+Added: Investment securities with original maturities of 90 days or less when purchased are presented within cash and cash equivalents (December 31, 2024:
+Added: $ 15.3 million, December 31, 2023:
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.
4 unchanged sentences
2.3.13 Accounts receivable
−Removed: Accounts receivables include amounts due from services provided to the Company’s licensing and collaboration partners as well as unconditional rights to consideration from its licensing and collaboration partners.
+Added: Accounts receivables include amounts due from services provided to CSL Behring as well as unconditional rights to consideration from CSL Behring.
2.3.14 Inventories
−Removed: The Company started producing commercial materials in April 2022 to supply CSL Behring in accordance with the June 2020 Development and Commercial Supply Agreement between the Company and CSL Behring.
−Removed: From this date onwards, the Company presents the costs associated with the aforementioned activities as cost of contract manufacturing.
−Removed: Refer to Note 5 “Collaboration arrangements and concentration of credit risk” for further detail.
+Added: The Company started producing commercial materials in April 2022 to supply CSL Behring in accordance with a June 2020 Development and Commercial Supply Agreement between the Company and CSL Behring.
+Added: From this date until the Closing of the Lexington Transaction in July 2024, the Company presented the costs associated with the aforementioned activities as cost of contract manufacturing.
Per ASC 330 , Inventory , inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out basis.
−Removed: The Company capitalizes raw materials to the extent these can be used in contract manufacturing for CSL Behring.
−Removed: The Company uses standard costs, approximating average costs to determine its cost basis for work in progress and finished goods.
−Removed: 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.
−Removed: As applicable, write-downs resulting from adjustments to net realizable value will be recorded to cost of contract manufacturing.
+Added: The Company capitalized raw materials to the extent these were used in contract manufacturing for CSL Behring.
+Added: The Company used standard costs, approximating average costs to determine its cost basis for work in progress and finished goods.
+Added: The Company’s assessment of recoverability value required the use of estimates regarding the net realizable value of its inventory balances, including an assessment of excess or obsolete inventory.
+Added: As applicable, write-downs resulting from adjustments to net realizable value were recorded to cost of contract manufacturing.
2.3.15 Prepaid expenses
23 unchanged sentences
Leases with a term of twelve months or less are not recognized on the consolidated balance sheets.
−Removed: The Company recognizes lease cost on a straight-line basis and presents these costs as operating expenses within the Consolidated statements of operations and comprehensive income / (loss).
+Added: The Company recognizes lease cost on a straight-line basis and presents these costs as operating expenses within the Consolidated statements of operations and comprehensive loss.
The Company presents lease payments within cash flows from operations within the Consolidated statements of cash flows.
8 unchanged sentences
2.3.21 Pensions and other post-retirement benefit plans
−Removed: 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.
+Added: The Company maintains a defined contribution pension plan for all employees 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.
1 unchanged sentence
Prepaid contributions are recognized as an asset to the extent that a cash refund or a reduction in the future payments is available.
−Removed: In 2016, the Company adopted a qualified 401(k) Plan for all employees located in the United States.
+Added: The Company maintains 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.
3 unchanged sentences
If employer contributions are made in periods after an individual retires or terminates, the estimated cost is accrued during the employee’s service period.
−Removed: The Company maintains defined benefit plans for its Swiss employees, including retirement benefit plans required by applicable local law.
+Added: Expenses under the defined contribution plans were $ 2.7 million, $ 3.6 million and $ 2.7 million for the years ended December 31, 2024, 2023 and 2022, respectively.
+Added: The Company maintains a defined benefit plan for its Swiss employees, including retirement benefit plans required by applicable local law.
The Company accounts for pension assets and liabilities in accordance with ASC 715, Compensation - Retirement Benefits , which requires the recognition of the funded status of pension plans in the Company’s consolidated balance sheet.
−Removed: The liability in respect to defined benefit pension plans is the projected benefit obligation calculated annually by independent actuaries using the projected unit credit method.
−Removed: The projected benefit obligation as of December 31, 2023 represents the actuarial present value of the estimated future payments required to settle the obligation that is attributable to employee services rendered before that date.
+Added: The liability in respect to defined benefit pension plan is the projected benefit obligation calculated annually by independent actuaries using the projected unit credit method.
+Added: The projected benefit obligations as of December 31, 2024 and December 31, 2023 represents the actuarial present value of the estimated future payments required to settle the obligation that is attributable to employee services rendered before that date.
Service cost is reported in research and development and general and administrative expenses.
15 unchanged sentences
The Company primarily generates revenue from its commercialization and license agreement with CSL Behring.
−Removed: The Company generated revenue from services provided to Bristol-Myers Squibb (“BMS”) until February 21, 2023 (“Termination Date”).
−Removed: CSL Behring collaboration
−Removed: 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”).
−Removed: On May 6, 2021, the CSL Behring Agreement became fully effective (“Closing”).
−Removed: The Company concluded that CSL Behring is a customer in accordance with ASC 606, Revenue from Contracts with Customers and identified two material performance obligations related to the CSL Behring Agreement:
−Removed: (i) Sale of the exclusive global rights to etranacogene dezaparvovec, a gene therapy for patients with hemophilia B (the “Product”) (“License Sale”);
−Removed: (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”).
−Removed: These performance obligations were 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.
−Removed: 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”).
−Removed: 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.
+Added: The Company generated revenue from services provided to Bristol-Myers Squibb (“BMS”) until February 21, 2023.
+Added: License revenue
+Added: In June 2020 the Company entered into a commercialization and license agreement pursuant to which CSL Behring received exclusive global rights to HEMGENIX® which became fully effective in May 2021.
+Added: The Company concluded that CSL Behring is a customer in accordance with ASC 606 , Revenue from Contracts with Customers.
+Added: The Company recognized the revenue related to its performance obligation to sell the exclusive global rights to HEMGENIX® in May 2021.
+Added: The Company also allocated the following consideration to this performance obligation:
+Added: i) Variable milestone payments;
+Added: ii) Sales milestone payments and royalties
+Added: The Company recognizes license revenue in relation to the regulatory and sales milestone payments when it becomes probable that these be achieved as well as when royalties on sales of HEMGENIX® have been earned.
Refer to Note 18 “ Collaboration arrangements and concentration of credit risk ” for further detail.
−Removed: Bristol-Myers Squib collaboration
−Removed: The Company initially entered into collaboration, research, and license agreements with BMS in 2015 (“BMS CLA”) and amended them in 2020 (“amended BMS CLA”).
−Removed: The agreement terminated on February 21, 2023.
−Removed: The Company provided pre-clinical research activities ("Collaboration Revenue") under the amended BMS CLA.
+Added: Contract manufacturing revenue
+Added: The Company between April 2022 and July 2024 contract manufactured HEMGENIX® for CSL Behring in accordance with a June 2020 Development and Commercial Supply Agreement between the Company and CSL Behring.
+Added: Following the Closing of the Lexington Transaction in July 2024, title to HEMGENIX® drug product supply directly passes from the contract manufacturer, Genezen, to CSL Behring.
+Added: The Company does not control HEMGENIX® before it is transferred to CSL Behring.
+Added: The Company arranges for HEMGENIX® to be provided by Genezen to CSL Behring.
+Added: The Company determined that it is an agent in the sale of HEMGENIX® to CSL Behring with related accounts receivable presented in other receivables in the consolidated balance sheets.
+Added: The Company recognized contract manufacturing revenue when ownership transferred to CSL Behring.
+Added: Collaboration revenue
+Added: Collaboration revenue related to contracted services is recognized when performance obligations are satisfied.
2.3.24 Other income, other expense
1 unchanged sentence
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.
−Removed: The Company’s other income also consists of employee retention credits received under the U.S.
−Removed: Coronavirus Aid, Relief, and Economic Security Act, income related to a settlement agreement that the Company and VectorY B.V.
−Removed: entered into in April 2021, as well as income from subleasing part of the Company’s Amsterdam facility.
−Removed: Other expense consists of expenses incurred in relation to the subleasing income.
2.3.25 Research and development expenses
1 unchanged sentence
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).
−Removed: 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.
+Added: In addition, research and development expenses consisted 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.
22 unchanged sentences
Debt issuance cost is amortized together with the interest expense recorded.
+Added: Interest expense, net of interest paid is presented as an adjustment to reconcile net loss to net cash used in operating activities in the consolidated statement of cash flows.
2.3.28 Restructuring expenses
−Removed: Restructuring charges principally consist of one-time termination benefits.
+Added: Restructuring charges consist of one-time termination benefits.
The Company records one-time termination benefits in accordance with ASC 420, Exit or Disposal Cost Obligations .
One-time termination benefits are expensed at the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period.
−Removed: Other costs relate to the impairment of the Lexington facility that was closed as a result of a reorganization plan (the “Reorganization”).
−Removed: The Company has recognized an impairment loss of the right-of-use asset and corresponding leasehold improvements in accordance with ASC 360, Property, Plant and Equipment.
+Added: The Company recorded restructuring charges in accordance with ASC 712, Compensation—Nonretirement Postemployment Benefits when the terms offered were substantially similar to the terms recently offered.
+Added: Under this standard, the Company recognizes a liability when the obligation is probable and can be estimated.
+Added: The Company estimates the cost of these benefits and records a liability for the expected future payments.
+Added: The liability is adjusted periodically to reflect changes in estimates, and related costs are recognized in the period incurred.
+Added: Other costs relate to the impairment of the Company’s research and development laboratory in Lexington that was closed as a result of an October 2023 reorganization.
+Added: The Company recognized an impairment loss of the right-of-use asset and corresponding leasehold improvements in accordance with ASC 360 , Property, Plant and Equipment .
2.3.29 Recently Adopted Accounting Pronouncements
−Removed: Recent Accounting Pronouncements Not Yet Effective
−Removed: uniQure France SAS transaction
−Removed: At the Acquisition Date, the Company acquired uniQure France SAS (formerly Corlieve Therapeutics SAS).
−Removed: Following uniQure France SAS’s formation in November 2019, uniQure France SAS obtained exclusive licenses to certain patents from two French research institutions that continue to collaborate with the Company.
−Removed: uniQure France SAS also obtained an exclusive license from Regenxbio Inc.
−Removed: (“Regenxbio”).
−Removed: uniQure France SAS and Regenxbio simultaneously entered into a collaboration plan related to agreed joint preclinical research and development activities.
−Removed: At the Acquisition Date, uniQure France SAS and its Swiss subsidiary, Corlieve Therapeutics AG, employed seven employees.
−Removed: The Company evaluated the uniQure France SAS 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.
−Removed: Based on the fair values of the gross assets acquired, the Company determined the screen test was not met.
−Removed: 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.
−Removed: 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.
−Removed: Identifiable assets and liabilities of uniQure France SAS, including identifiable intangible assets, were recorded at their fair values as of the Acquisition Date, when the Company obtained control.
−Removed: The excess of the fair value of the consideration transferred over the fair value of the net assets acquired was recorded as goodwill.
−Removed: Consideration
−Removed: On the Acquisition Date, the Company acquired 97.7 % of the outstanding ordinary shares of uniQure France SAS in return for EUR 44.9 million ($ 53.3 million as of the Acquisition Date).
−Removed: 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).
−Removed: In addition to the payments to acquire 100 % of the outstanding ordinary shares, uniQure France SAS’s former shareholders are eligible to receive up to EUR 40.0 million ($ 44.1 million as of December 31, 2023) upon achievement of certain development milestones through Phase I/II, of which EUR 10.0 million ($ 10.6 million) was paid in September 2023, and EUR 160.0 million ($ 176.6 million as of December 31, 2023) upon achievement of certain milestones associated with Phase III development and obtaining approval to commercialize uniQure France SAS’s target candidate for the treatment of mesial temporal lobe epilepsy (“AMT-260” or “MTLE”) in the United States of America and the European Union.
−Removed: The Company may elect to pay up to 25 % of such milestone payments through the issuance of the Company’s ordinary shares.
−Removed: 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.
−Removed: Identified intangible assets
−Removed: 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 uniQure France SAS in 2019 constitute an IPR&D Intangible Asset.
−Removed: The Company determined the fair value of the IPR&D Intangible Asset using a present value model based on expected cash flows.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Deferred tax liability, net
−Removed: uniQure France SAS’s deferred tax assets at the time of acquisition amounted to EUR 1.5 million ($ 1.7 million).
−Removed: 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 %.
−Removed: The Company consequently recorded a net deferred tax liability of EUR 11.9 million ($ 14.2 million as of the Acquisition Date).
−Removed: Changes in the net deferred tax liability after the Acquisition Date will be recorded in income tax expense in the Consolidated statements of operations and comprehensive income / (loss).
−Removed: Goodwill represents the excess of total consideration over the estimated fair value of net assets acquired.
−Removed: The Company recorded EUR 23.9 million ($ 28.4 million) of goodwill in the consolidated balance sheet as of the Acquisition Date.
−Removed: 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.
−Removed: The Company allocated the goodwill to its reporting unit.
−Removed: The Company does not expect any portion of this goodwill to be deductible for income tax purposes.
−Removed: As of the Acquisition Date, uniQure France SAS 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.
−Removed: As of the Acquisition Date, uniQure France SAS 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.
−Removed: 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.
−Removed: Reorganization
−Removed: On October 5, 2023, the Company announced the Reorganization.
−Removed: As a result, the Company recorded severance and other personnel related expenses for the impacted employees.
−Removed: In 2023, as a part of the Reorganization, the Company decided to sublease one of its laboratories in Lexington.
−Removed: The carrying amount of the right-of-use asset was determined not to be recoverable.
−Removed: As a result, the Company recorded impairment charges for the related operating lease right-of-use assets and leasehold improvements.
−Removed: A summary of the restructuring charges for the year ended December 31, 2023 by major activity type is as follows:
+Added: In the year ended December 31, 2024, the Company adopted Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280):
+Added: Improvements to Reportable Segment Disclosures (“ASU 2023-07”).
+Added: This update requires the Company to disclose segment expenses that are significant and regularly provided to the Company’s chief operating decision maker (“CODM”).
+Added: In addition, ASU 2023-07 requires the Company to disclose the title and position of its CODM and how the CODM uses segment profit or loss information in assessing segment performance and deciding how to allocate resources.
+Added: The adoption of this update did not have a material impact on the Company’s financial position or results of operations but resulted in expanded disclosures in the segment reporting section of the consolidated financial statements.
+Added: The Company adopted ASU 2023-07 using a retrospective transition method.
+Added: There are no other recently issued accounting pronouncements pending adoption that are applicable or expected to have a material impact on the Company.
+Added: Divestiture of commercial manufacturing activities
+Added: Description of transaction
+Added: On June 29, 2024, affiliates of the Company agreed with Genezen to sell the Company’s commercial manufacturing activities located in Lexington, MA.
+Added: The Lexington Transaction closed on July 22, 2024.
+Added: Genezen extended offers of employment to a significant majority of the Company’s employees located at the Lexington facility (the “Lexington Facility”), with the remaining employees terminated effective August 30, 2024.
+Added: and uniQure B.V., both wholly owned subsidiaries of the Company, entered into an APA with Genezen on June 29, 2024.
+Added: Pursuant to the APA, Genezen agreed to acquire the manufacturing facility including equipment and related manufacturing operations with a carrying value of $ 15.2 million, inventory with a carrying value of $ 8.8 million and certain other assets (including allocated goodwill) with a carrying value of $ 2.8 million associated with the Lexington Facility on Closing.
+Added: As consideration, the Company received (i) shares of newly issued Series C preferred stock of Genezen Holdings Inc.
+Added: which are convertible into Genezen common stock and will accrue an 8.0 % per annum cumulative dividend, (ii) a convertible promissory note with a nominal amount of $ 12.5 million, bearing interest at 8.0 % per annum and maturing 63 months following the date of issuance and (iii) a right to purchase HEMGENIX® at terms considered favorable to market terms.
+Added: The Company also included a firm purchase commitment liability for its customer contract with CSL Behring inherently related to the right to purchase HEMGENIX® in the consideration received.
+Added: The Company recorded the Series C preferred stock in Genezen Holdings Inc.
+Added: issued to the Company at Closing at its fair market value of $ 12.5 million.
+Added: The Series C preferred stock had a carrying value of $ 11.8 million as of December 31, 2024.
+Added: The convertible promissory note was recognized at its fair value of $ 13.3 million at Closing.
+Added: The convertible promissory note had a balance of $ 13.7 million as of December 31, 2024.
+Added: During the year ended December 31, 2024, the Company recognized $ 0.4 million of interest income.
+Added: As of December 31, 2024, the Company has not recorded an allowance for credit losses related to the convertible promissory note.
+Added: uniQure Inc., Genezen and the landlord of the Lexington Facility entered into an agreement for uniQure to assign and Genezen to assume the existing lease agreement between uniQure and the landlord at Closing.
+Added: The Company also amended its original July 2013 guarantee to continue guaranteeing rental payments owed by Genezen until the end of the current term on May 31, 2029.
+Added: In the event of Genezen’s default related to rental payments owed to the landlord, uniQure is entitled to terminate the assignment agreement and step into the original lease agreement.
+Added: On Closing, the Company de-recognized its right of use asset with a carrying amount of $ 11.8 million and related lease liability for the facility of $ 17.7 million.
+Added: Following the Closing, $ 1.7 million of deposits were released and reclassified from restricted cash into cash.
+Added: At Closing, uniQure Inc.
+Added: entered into a CSA with Genezen.
+Added: Pursuant to the terms of the CSA, the parties agreed to subcontract the manufacturing of HEMGENIX® to Genezen.
+Added: The CSA includes a minimum term of three years and minimum purchase commitments of HEMGENIX® commercial supplies of $ 43.3 million over the first three years , unless certain contractual provisions are triggered.
+Added: The CSA provides the Company with rights to purchase HEMGENIX® at terms considered favorable to market terms.
+Added: In accordance with ASC 805 Business Combinations , the Company recorded an intangible asset valued at $ 16.7 million with respect to these favorable terms.
+Added: The intangible asset will be amortized on a straight-line basis over a three-year term, commencing at Closing.
+Added: Amortization expense of $ 2.5 million (presented within Other expense in the Consolidated Statement of Operations and Comprehensive Loss) was recorded during the year ended December 31, 2024.
+Added: The Company’s obligations with respect to the supply of HEMGENIX® to CSL Behring pursuant to the Development and Commercial Supply Agreement between uniQure biopharma and CSL Behring Inc (the “DCSA”) remain in effect notwithstanding the subcontracting to Genezen.
+Added: The Company expects to resell HEMGENIX® material purchased from Genezen via its minimum commitments to CSL Behring at a loss.
+Added: In accordance with ASC 330 Inventory , the Company, at Closing, recognized a liability of $ 8.8 million related to the net losses expected from the purchase of these minimum commitments.
+Added: The liability was accounted for as a reduction of the consideration received.
+Added: As of December 31, 2024, the Company classified $ 1.6 million of the liability as Accrued expenses and other current liabilities and $ 4.8 million within Other non-current liabilities in the Consolidated Balance Sheets.
+Added: The Lexington Transaction was accounted for as a divestment of the Company’s commercial manufacturing activities.
+Added: The total net consideration received of $ 25.4 million, less costs associated with the sale of $ 3.3 million, exceeded the $ 20.9 million fair market value of the net assets transferred (including allocated goodwill) by $ 1.2 million.
+Added: The excess over the fair market value was recognized as a net gain in Other income in the Consolidated Statement of Operations and Comprehensive Loss.
+Added: At Closing, the Company paid a total of $ 8.3 million to Genezen and CSL related to adjustments of working capital and to obtain consent to proceed with the divestiture.
+Added: Additionally, uniQure biopharma entered into a development and other manufacturing services agreement (“DMSA”) with Genezen at Closing.
+Added: Pursuant to the DMSA, the Company is entitled to receive, as a preferred customer, manufacturing and development services to support the Company’s investigational gene therapy programs and other services related to HEMGENIX® (other than its manufacturing and supply obligations under the CSA).
+Added: The DMSA has a minimum term of three years and requires the Company to purchase services for a total minimum of $ 14.0 million.
+Added: Restructuring
+Added: In 2024, as part of the Lexington Transaction, the Company terminated certain employees that did not transfer to Genezen.
+Added: The Company incurred $ 1.4 million of expenses related to termination benefits offered to these employees, which were recorded as Research and Development Expense and Selling, General and Administrative Expense during the year ended December 31, 2024.
+Added: On August 1, 2024, the Company announced a global organizational restructuring.
+Added: As a result, the Company recorded $ 3.8 million of severance and other personnel-related expenses during the year ended December 31, 2024.
+Added: On October 5, 2023, the Company announced a reorganization plan.
+Added: As a result, the Company recorded $ 2.5 million of severance and other personnel related expenses for the impacted employees.
+Added: A summary of the restructuring charges for the years ended December 31, 2024 and December 31, 2023 are as follows:
+Added: Year ended December 31,
+Added: Year ended December 31,
Severance and other personnel costs
−Removed: Impairment Charges
(in thousands)
Research and development
−Removed: General and administrative
+Added: Selling, general and administrative
A summary of the changes in the severance and other personnel liabilities, included within accrued expenses and other current liabilities on the consolidated balance sheets, related to the workforce reduction is as follows:
−Removed: Amount of liability
(in thousands)
−Removed: Balance as of January 1, 2023
+Added: (in thousands)
+Added: Amount of liability at beginning of period
Severance and other personnel costs
Cash payments during the period
−Removed: Balance as of December 31, 2023
−Removed: Collaboration arrangements and concentration of credit risk
−Removed: CSL Behring collaboration
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: At Closing, the Company evaluated the amounts of potential payments and the likelihood that the payments will be received.
−Removed: The Company utilized the most likely amount method to estimate the variable consideration to be included in the transaction price.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The Company recorded $ 100.0 million in variable milestone revenue related to a first sale of HEMGENIX ® in the U.S.
−Removed: during the year ended December 31, 2022 as the Company considered the occurrence of this event to be probable following the November 2022 BLA approval of HEMGENIX ® .
−Removed: The Company collected the $ 100.0 million payment from CSL Behring in July 2023 following the first sale of the Product in the U.S in June 2023.
−Removed: The Company is also eligible to receive up to $ 1.3 billion in additional payments based on the achievement of commercial milestones, which are not subject to the Royalty Financing Agreement.
−Removed: Royalties on the sale of HEMGENIX® are recorded once earned and are presented as license revenue.
−Removed: The Company recognized $ 2.8 million (of which all related to royalty revenue), $ 100.0 million ( nil related to royalty revenue) and $ 517.4 million ( nil related to royalty revenue) of revenues related to the License Sale in the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: The Company recorded 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.
−Removed: Manufacturing Development
−Removed: The Company determined that a $ 50.0 million variable milestone payment related to Manufacturing Development should be allocated to the Manufacturing Development performance obligation.
−Removed: 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.
−Removed: Manufacturing Development includes providing information regarding a next generation manufacturing process of the Product to CSL Behring.
−Removed: CSL Behring did not request such services during the year ended December 31, 2023.
−Removed: The variable consideration will be reduced based on a formula linked to quantities supplied using the currently approved manufacturing process following the one year anniversaries of the BLA and MAA approvals.
−Removed: In conjunction with the ongoing technology transfer (see below), the Company is not actively generating information with respect to a next generation manufacturing process of the Product.
−Removed: The Company utilized the most likely amount method to estimate the variable consideration to be included in the transaction price.
−Removed: As of December 31, 2023, the Company has not recognized any revenue related to the Manufacturing Development milestone.
−Removed: Contract manufacturing
−Removed: 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 HEMGENIX ® to CSL Behring at an agreed-upon price commensurate with the SSP.
−Removed: 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.
−Removed: 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.
−Removed: The Company generated $ 10.8 million, $ 1.7 million and nil contract manufacturing revenue from sales to CSL Behring during the years ended December 31, 2023, 2022 and 2021.
−Removed: The Company recognizes contract manufacturing revenue when CSL Behring obtains control of HEMGENIX ®.
−Removed: The Company incurred $ 13.6 million, $ 2.1 million and nil of cost in relation to its contract manufacturing activities during the years ended December 31, 2023, 2022 and 2021.
−Removed: Collaboration services
−Removed: 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.
−Removed: Activities related to on-demand development services and other services in accordance with the CSL Behring Agreement 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 reimbursed agreed third-party expenses incurred in relation to performing these activities.
−Removed: The Company concluded that these rights at Closing did not represent material rights.
−Removed: The Company recognized $ 2.3 million of collaboration revenue in the year ended December 31, 2023, compared to $ 3.0 million and $ 2.4 million in the same periods in 2022 and 2021.
−Removed: Accounts r eceivable and c ontract asset
−Removed: As of December 31, 2023, the Company recorded accounts receivable of $ 4.0 million from CSL Behring related to collaboration services, contract manufacturing revenue and royalty revenue.
−Removed: 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 for a milestone due from CSL Behring following the first sale of HEMGENIX ® in the U.S., which was collected in July 2023.
−Removed: 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™ which were collected in March and April 2022.
−Removed: Bristol-Myers Squibb collaboration
−Removed: On November 21, 2022, the Company received written notice that BMS is terminating the BMS CLA as amended effective February 21, 2023.
−Removed: 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 amended BMS CLA as well as other related agreements.
−Removed: Collaboration revenue related to these contracted services was recognized when performance obligations were satisfied.
−Removed: Total collaboration revenue generated with BMS are as follows:
−Removed: Years ended December 31,
−Removed: (in thousands)
−Removed: Bristol Myers Squibb
−Removed: Amounts owed by BMS in relation to the collaboration revenue are as follows (presented as “Accounts receivable”) as of December 31, 2023:
−Removed: (in thousands)
−Removed: Bristol Myers Squibb
−Removed: Investments securities
−Removed: The following table summarizes the Company’s investments into sovereign debt as of December 31, 2023 and 2022:
+Added: Amount of liability at end of period
+Added: Investment securities
+Added: The following table summarizes the Company’s investments into government debt securities as of December 31, 2024 and 2023:
At December 31, 2024
14 unchanged sentences
Government debt securities (held-to-maturity)
−Removed: Non-current investments:
−Removed: Government debt securities (held-to-maturity)
The Company invests in short-term U.S.
−Removed: and European government bonds with the highest investment credit rating.
+Added: and European government debt securities with the highest investment credit rating.
and European government bonds are U.S.
dollar and euro denominated, respectively.
+Added: Investment securities with original maturities of 90 days or less when purchased are presented within cash and cash equivalents and measured at amortized cost (December 31, 2024:
+Added: $ 15.3 million, December 31, 2023:
Inputs to the fair value of the investments are considered Level 2 inputs.
−Removed: The following table summarizes the inventory balances, net of reserves, as of December 31, 2023:
+Added: The following table summarizes the inventories, net balances as of December 31, 2024 and December 31, 2023:
(in thousands)
2 unchanged sentences
Finished goods
−Removed: The Company recorded write downs of $ 1.6 million and nil for the years ended December 31, 2023 and December 31, 2022.
−Removed: The costs are recognized as Cost of Contract Manufacturing Revenues.
−Removed: Fair value measurement and Other non-operating (losses) / gains
+Added: The Company recorded write downs to net realizable value of $ 6.3 million and $ 1.6 million for the years ended December 31, 2024 and December 31, 2023.
+Added: The costs were recognized as Cost of Contract Manufacturing Revenues.
+Added: At December 31, 2023, the Company recorded an allowance for inventory of $ 1.6 million.
+Added: The Company sold its inventories as part of the Lexington Transaction (refer to Note 3 “Divestiture of commercial manufacturing activities” and Note 4 “Restructuring” ).
+Added: Fair value measurement
The Company measures certain financial assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting.
8 unchanged sentences
Balance at December 31, 2021
−Removed: Amount recorded for contingent consideration on Acquisition Date of uniQure France SAS
−Removed: Net losses recognized in profit or loss
−Removed: Currency translation effects
−Removed: Balance at December 31, 2021
Net losses / (gains) recognized in profit or loss
5 unchanged sentences
Balance at December 31, 2023
+Added: Net (gain) recognized in profit or loss
+Added: Contingent consideration milestone payment
+Added: Currency translation effects
+Added: Balance at December 31, 2024
Contingent consideration
−Removed: The Company is required to pay up to EUR 178.8 million ($ 197.3 million at the December 31, 2023 foreign exchange rate) to the former shareholders of uniQure France SAS (formerly Corlieve Therapeutics SAS) upon the achievement of contractually defined milestones in connection with the Company’s acquisition of uniQure France (refer to Note 3 “uniQure France SAS transaction” ).
−Removed: The Company recorded a liability for the fair market value of the contingent consideration of EUR 20.2 million ($ 24.0 million) at the Acquisition Date.
−Removed: The fair market value was determined using unobservable initial inputs with respect to (i) the probability of achieving the relevant milestones, or POS, (ii) the estimated timing of achieving such milestones, and (iii) the interest rate used to discount the payments.
−Removed: The Company determined the fair market value of the contingent consideration by calculating the probability-adjusted payments based on each milestone’s probability of achievement.
−Removed: The probability-adjusted payments were then discounted to present value using a discount rate representing the Company’s credit risk.
−Removed: This discount rate was determined using the effective interest rate of the Company’s existing debt facility adjusted for difference in maturity dates based on market data on effective yields for U.S.
−Removed: bonds with a CCC credit rating.
−Removed: In September 2023, a milestone payment of EUR 10.0 million ($ 10.6 million) was paid, of which EUR 8.9 million ($ 9.6 million) related to contingent consideration.
−Removed: The fair value of the contingent consideration as of December 31, 2023 was $ 43.0 million (December 31, 2022:
+Added: The Company is required to pay up to EUR 143.1 million ($ 148.6 million at the December 31, 2024 foreign exchange rate) to the former shareholders of uniQure France SAS (formerly Corlieve Therapeutics SAS) upon the achievement of the remaining contractually defined milestones in connection with the Company’s acquisition of uniQure France in 2021 .
+Added: The fair value of the contingent consideration liability related to this acquisition as of December 31, 2024 was $ 10.9 million (December 31, 2023:
$ 43.0 million) using discount rates of approximately 15.3 % to 16.2 % (December 31, 2023:
15.3 % to 15.6 %).
−Removed: Following the clearance of an Investigational New Drug (“IND”) application for AMT-260 in August 2023, the Company increased the probability of achieving a EUR 30.0 million ($ 33.1 million) milestone payment following the dosing of the first patient in Phase I/II clinical trial from 66.0 % to 100.0 %.
+Added: Following the clearance of an Investigational New Drug (“IND”) application for AMT-260 in August 2023, the Company had increased the probability of achieving a EUR 30.0 million ($ 33.1 million) milestone payment following the dosing of the first patient in Phase I/II clinical trial from 66.0 % to 100.0 %.
This also resulted in an increase of the probability that AMT-260 may advance to late-stage development and commercialization.
−Removed: If as of December 31, 2023 the Company had assumed a 100 % likelihood of AMT-260 advancing into a Phase III clinical study, then the fair value of the contingent consideration would have increased to $ 75.9 million.
+Added: In December 2024, a milestone payment of EUR 30.0 million ($ 31.5 million) was paid, of which EUR 26.8 million ($ 28.2 million) related to contingent consideration.
+Added: In September 2023, a milestone payment of EUR 10.0 million ($ 10.6 million) was paid, of which EUR 8.9 million ($ 9.6 million) related to contingent consideration.
+Added: If as of December 31, 2024 the Company had assumed a 100 % likelihood of AMT-260 advancing into a Phase III clinical study, then the fair value of the contingent consideration would have increased to EUR 33.7 million ($ 35.0 million).
If as of December 31, 2024 the Company had assumed that it would discontinue development of the AMT-260 program, then the contingent consideration would have been released to income.
−Removed: As of December 31, 2023, the Company classified $ 28.2 million of the total contingent consideration of $ 43.0 million as current liabilities.
+Added: As of December 31, 2024, the Company classified no ne of the total contingent consideration of $ 10.9 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
−Removed: The Company recorded the following results in other non-operating (losses) / gains related to the changes in the fair value of derivative financial instruments.
−Removed: Years ended December 31,
−Removed: (in thousands)
−Removed: Other non-operating gains:
−Removed: Derivative gains
−Removed: Total other non-operating gains:
−Removed: Other non-operating losses:
−Removed: Derivative losses
−Removed: Other non-operating gains / (losses), net
Derivative financial instruments BMS
−Removed: 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”).
+Added: In December 2020, as part of the amended BMS CLA, the Company and BMS had agreed that upon the consummation of a change of control transaction of uniQure occurring prior to December 2026 or BMS’ delivery of a cessation notice (as contractually defined) the Company (or its third party acquirer) should have paid to BMS a one-time, non-refundable, non-creditable contractually defined payment (“CoC-payment”).
The amended BMS CLA was terminated on February 21, 2023.
−Removed: The Company had previously 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.
−Removed: 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.
−Removed: This resulted in the derecognition of the derivative financial liability for the year ended December 31, 2022.
−Removed: Accordingly, the Company recorded a $ 2.8 million gain within “Other non-operating (losses) / gains” in the year ended December 31, 2022 and no such gains or losses were recorded in the year ended December 31, 2023.
−Removed: As of December 31, 2023, the Company recorded $ 0.5 million liability related to consideration for post-acquisition services, presented within Other non-current liabilities in connection with the Company’s acquisition of uniQure France SAS (December 31, 2022:
+Added: The Company had previously determined that the CoC-payment should be recorded as a derivative financial liability upon initial recognition and that subsequent changes in the fair market value of this derivative financial liability should be recorded in profit and loss.
+Added: As a result of the derecognition of the derivative financial liability in the year ended December 31, 2022, the Company recorded a $ 2.8 million gain within “Other non-operating (losses) / gains”.
+Added: As of December 31, 2024, the Company recorded $ 0.4 million liabilities related to consideration for post-acquisition services, presented within Other non-current liabilities in connection with the Company’s acquisition of uniQure France SAS (December 31, 2023:
$ 0.5 million).
16 unchanged sentences
$ 8.2 million).
−Removed: 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.
+Added: Depreciation expense is allocated to research and development expenses and cost of contract manufacturing to the extent it related to the Company’s commercial manufacturing facility and equipment and laboratory equipment.
All other depreciation expenses are allocated to selling, general and administrative expense.
+Added: The Company sold property, plant and equipment with a carrying value of $ 15.2 million, including leasehold improvements with a carrying value of $ 6.4 million, laboratory and office equipment with a carrying value of $ 6.0 million as well as assets under construction with a carrying value of $ 2.8 million as part of the Lexington Transaction (refer to Note 3 “ Divestment of commercial manufacturing activities” ).
The following table summarizes property, plant, and equipment by geographic region.
1 unchanged sentence
Lexington, Massachusetts (United States of America)
−Removed: Amsterdam (the Netherlands)
Right-of-use asset and lease liabilities
2 unchanged sentences
In July 2013, the Company entered into a lease for a facility in Lexington, Massachusetts, United States.
−Removed: 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.
−Removed: Originally, the lease for this facility had a termination date of 2024.
−Removed: In November 2018, the term was expanded by five years to June 2029.
−Removed: The lease continues to be renewable for two subsequent five-year terms.
−Removed: Additionally, the lease was expanded to include an additional 30,655 square feet within the same facility and for the same term.
−Removed: The lease of the expansion space commenced on June 1, 2019.
−Removed: The contractually fixed annual increase of lease payments through 2029 for both the extension and expansion lease have been included in the lease payments.
−Removed: 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.
−Removed: The lease commenced in May 2022.
−Removed: Following the Company’s announcement of the Reorganization, the Company incurred costs amounting to $ 1.4 million associated with the impairment of the right-of-use asset and its associated leasehold improvements’ carrying value that was determined not be recoverable as of the cease-use date in late 2023.
−Removed: This facility is intended to be subleased in 2024.
−Removed: 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.
−Removed: The lease commenced in November 2022 and is set for a non-cancellable period of seven years and four months .
+Added: In November 2018, the term was expanded by five years to June 2029 and include an additional 30,655 square feet within the same facility and for the same term.
+Added: The Company in July 2024 assigned the leases to Genezen as part of its divestment of its commercial manufacturing activities and as a result de-recognized its right of use asset and related lease liability.
+Added: Refer to Note 3 “ Divestment of commercial manufacturing activities”.
+Added: In December 2021, the Company entered into a lease for an research and development facility in Lexington, Massachusetts, United States of approximately 13,501 square feet of space.
+Added: The lease commenced in May 2022 and is set for a non-cancellable period ending March 2029.
+Added: Following the Company’s announcement of a reorganization in 2023, the Company incurred costs amounting to $ 1.4 million for the year ended December 31, 2023, associated with the impairment of the right-of-use asset and its associated leasehold improvements’ carrying value that was determined not be recoverable as of the cease-use date in late 2023.
+Added: Commencing August 2024 the Company subleased this facility for the residual term.
+Added: The fixed lease payments to be received during the remaining term under the agreement to sub-lease amount to $ 3.2 million as of December 31, 2024.
+Added: In February 2022, the Company entered into a new lease for an additional facility in Lexington, Massachusetts, United States of approximately 12,716 square feet.
+Added: The lease commenced in November 2022 and is set for a non-cancellable period ending March 2030.
The lease is renewable for one five-year term.
1 unchanged sentence
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.
−Removed: The lease for the facility terminates in 2032, with an option to extend in increments of five-year periods.
+Added: The lease for the facility terminates in February 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.
−Removed: 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.
−Removed: In February 2020, the Company amended the agreement to sub-lease to take back one of the three floors effective March 1, 2020.
−Removed: The fixed lease payments to be received during the remaining term under the agreement to sub-lease amount to EUR 3.6 million ($ 4.0 million) as of December 31, 2023.
−Removed: 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.
+Added: In May 2021 the Company leased an additional approximately 1,080 square meters of office space.
The lease expires in October 2028.
+Added: As of December 31, 2024 the Company is sub-leasing two 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.
+Added: The sublessee has informed the Company during 2024 of its intention to terminate the sub-lease.
+Added: The fixed lease payments to be received during the remaining term under the agreement to sub-lease amount to EUR 2.7 million ($ 2.8 million) as of December 31, 2024.
Operating lease liabilities
23 unchanged sentences
Undiscounted cash flows
−Removed: The table below reconciles the undiscounted cash flows as of December 31, 2023, 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, 2023.
+Added: The table below reconciles the undiscounted cash flows as of December 31, 2024, for each of the first five following years and the total of the remaining years to the operating lease liabilities recorded on the Consolidated balance sheet as of December 31, 2024.
Amsterdam (1)
6 unchanged sentences
(1) Payments are due in EUR and have been translated at the foreign exchange rate as of December 31, 2024, of $ 1.04 / €1.00
+Added: (2) Payments are due in CHF and have been translated at the foreign exchange rate as of December 31, 2024, of $ 1.10 / CHF1.00
Intangible assets, net and Goodwill
−Removed: The following table presents the Company’s acquired licenses and acquired IPR&D as of December 31:
+Added: The following table presents the Company’s acquired licenses, intangible asset related to the favorable supply terms under the CSA and acquired IPR&D as of December 31:
+Added: At December 31, 2024
+Added: Gross Carrying Amount
+Added: Accumulated Amortization
(in thousands)
Acquired licenses
−Removed: Less accumulated amortization
−Removed: Acquired licenses, net
+Added: Favorable supply terms under CSA
+Added: Total amortizable intangible assets
Acquired IPR&D intangible asset
−Removed: Intangibles, net
+Added: Total intangible assets
+Added: At December 31, 2023
+Added: Gross Carrying Amount
+Added: Accumulated Amortization
+Added: (in thousands)
Acquired licenses
−Removed: All acquired licenses are owned by uniQure biopharma B.V, a subsidiary of the Company.
−Removed: The remaining weighted average life is 10.5 years as of December 31, 2023 (December 31, 2022 11.5 years).
+Added: Total amortizable intangible assets
+Added: Acquired IPR&D intangible asset
+Added: Total intangible assets
As of December 31, 2024, the estimated future amortization expense for each of the five succeeding years and the period thereafter is as follows:
(in thousands)
−Removed: The amortization expense related to licenses for the year ended December 31, 2023 was $ 0.1 million (December 31, 2022:
+Added: Acquired licenses
+Added: All acquired licenses are owned by uniQure biopharma B.V, a subsidiary of the Company.
+Added: The remaining weighted average life is 9.5 years as of December 31, 2024 (December 31, 2023 10.5 years).
+Added: The amortization expense related to acquired licenses for the year ended December 31, 2024 was $ 0.1 million (December 31, 2023:
$ 0.1 million;
1 unchanged sentence
$ 0.4 million).
+Added: Favorable supply terms under CSA
+Added: As part of the Lexington Transaction, the Company recognized an intangible asset related to its rights to purchase HEMGENIX® at terms considered favorable to market terms.
+Added: Refer to Note 3 “ Divestment of commercial manufacturing activities”.
+Added: The intangible asset is amortized on a straight line basis over a three year period that commenced in July 2024.
+Added: The amortization expense related to the intangible asset for the year ended December 31, 2024 was $ 2.5 million (December 31, 2023 and 2022:
Acquired in-process research and development
−Removed: As part of its acquisition of uniQure France SAS as of July 30, 2021, the Company identified certain intangible assets related to an IPR&D Intangible Asset.
−Removed: Refer to Note 3 “uniQure France SAS transaction” .
−Removed: As part of its acquisition of uniQure France SAS as of July 30, 2021, the Company recorded goodwill.
−Removed: Refer to Note 3 “uniQure France SAS transaction” .
+Added: The IPR&D Intangible Asset was recorded as part of the Company’s July 2021 acquisition of uniQure France SAS.
+Added: Refer to Note 2.3.11.
+Added: The goodwill was recorded as part of the Company’s July 2021 acquisition of uniQure France SAS.
+Added: Refer to Note 2.3.11.
Accrued expenses and other current liabilities
3 unchanged sentences
Accruals for goods received from and services provided by vendors-not yet billed
+Added: Current portion of firm purchase commitment liability (refer to Note 3 "Divestiture of commercial manufacturing activities")
Liability owed to the Purchaser pursuant to the Royalty Financing Agreement
−Removed: Accrued contract fulfillment costs and costs to obtain a contract
Long-term debt
On June 14, 2013, the Company entered into a venture debt loan facility with Hercules Capital, Inc.
−Removed: (formerly known as Hercules Technology Growth Capital, Inc.) (“Hercules”), which was amended and restated on June 26, 2014, on May 6, 2016 (“2016 Amended Facility”) and on December 6, 2018 (“2018 Amended Facility”).
−Removed: On January 29, 2021, the Company and Hercules amended the 2018 Amended Facility (“2021 Amended Facility”).
−Removed: 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.
−Removed: On January 29, 2021, the Company drew down $ 35.0 million of the Tranche B.
−Removed: 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.
−Removed: 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 have been extended by the Company by up to two twelve-month periods.
−Removed: 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.
−Removed: On December 15, 2021, the Company and Hercules amended and restated the 2021 Amended Facility (“2021 Restated Facility”).
−Removed: 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.
−Removed: The Company drew down an additional $ 30.0 million, resulting in total principal outstanding as of December 31, 2021 of $ 100.0 million.
−Removed: The 2021 Restated Facility extended the loan’s maturity date from June 1, 2023 until December 1, 2025.
−Removed: 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 had been approved by the U.S.
−Removed: Food and Drug Administration (“FDA”) or (b) AMT-130 had advanced into a pivotal trial.
−Removed: 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.
−Removed: On May 12, 2023 the Company and Hercules amended the 2021 Restated Facility (the “2023 Amended Facility”).
−Removed: The total principal outstanding under the 2023 Amended Facility remained $ 100.0 million.
+Added: (formerly known as Hercules Technology Growth Capital, Inc.) (“Hercules”).
+Added: The facility was amended and restated in 2014, 2016, 2018, January 2021, December 2021 (the “2021 Restated Facility”), and on May 12, 2023 (the “2023 Amended Facility”) and July 22, 2024 (the “2024 Amended Facility”).
+Added: On July 19, 2024, in connection with the Closing of the Lexington Transaction and the amendment of the 2023 Amended Facility, the Company prepaid $ 50.0 million of the $ 100.0 million of principal outstanding as well as $ 3.1 million in end-of-term fees.
The 2023 Amended Facility extended the maturity date and interest-only period from December 1, 2025 to January 5, 2027 (the “Maturity Date”).
−Removed: The Company is required to repay the entire principal balance on the Maturity Date.
+Added: The total principal outstanding as of December 31, 2024 under the 2024 Amended Facility was $ 50.0 million.
+Added: The Company is required to repay the residual 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.
−Removed: The Company paid a $ 2.5 million back-end fee in June 2023.
−Removed: Under the 2023 Amended Facility, the Company owes a back-end fee of $ 4.9 million on December 1, 2025 and a back-end fee of $ 1.3 million on the Maturity Date.
+Added: Pursuant to the terms of the 2024 Amended Facility, the Company owes a back-end fee of $ 2.4 million on December 1, 2025 and a back-end fee of $ 0.6 million on the Maturity Date.
The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2024 Amended Facility was $ 51.9 million as of December 31, 2024, compared to an amortized cost of $ 102.9 million as of December 31, 2023, and is recorded net of discount and debt issuance costs.
−Removed: The foreign currency gain on the loan was $ 3.0 million in 2023 (2022:
−Removed: loss of $ 5.8 million;
+Added: The foreign currency loss on the loan was $ 4.1 million in 2024 (2023:
+Added: gain of $ 3.0 million;
loss of $ 5.8 million).
15 unchanged sentences
Under the terms of the Royalty Financing Agreement the Company received an upfront payment of $ 375.0 million in exchange for its rights to the lowest royalty tier on CSL Behring’s worldwide net sales of HEMGENIX® for certain current and future royalties due to the Company.
−Removed: The Company is also eligible to receive an additional $ 25.0 million milestone payment under the Royalty Financing Agreement if 2024 net sales of HEMGENIX® exceed a pre-specified threshold, as set forth in the Royalty Financing Agreement.
−Removed: The Purchaser will receive 1.85 times the upfront payment (or $ 693.8 million) and 1.85 times the $ 25.0 million milestone payment (if paid) until June 30, 2032 (“First Hard Cap Date”) if such thresholds are met or, if such cap is not met by June 30, 2032, up to 2.25 times of the upfront and milestone payment (if paid) through December 31, 2038.
−Removed: If 2024 net sales do not exceed a pre-specified threshold, the Company will be obligated to pay $ 25.0 million to the Purchaser but only to the extent that the Company achieves a future sales milestone under the CSL Behring Agreement.
−Removed: If such milestone payment is not due from CSL Behring, the Company is not obligated to pay any amounts to the Purchaser.
+Added: The Company will be obligated to pay $ 25.0 million of the first worldwide sales milestone payment from CSL Behring, if received, to the Purchaser.
+Added: The Purchaser will receive 1.85 times the upfront payment (or $ 693.8 million) until June 30, 2032 (“First Hard Cap Date”) if such thresholds are met or, if such cap is not met by June 30, 2032, up to 2.25 times of the upfront payment through December 31, 2038 (“Second Hard Cap Date”).
+Added: If, on or prior to the defined dates for each cap amount, the total amount of royalty payments received by the Purchaser equals or exceeds the cap amount applicable to such date, the Royalty Financing Agreement will automatically terminate and all rights to the HEMGENIX® royalty payments will revert back to the Company.
+Added: The Company has no obligation to repay any amounts received from the Purchaser in the event that the applicable cap amount is not reached during the term of the Royalty Financing Agreement.
The Company has retained the rights to all other royalties, as well as commercial milestones totaling up to $ 1.3 billion, under the terms of the CSL Behring Agreement.
2 unchanged sentences
Following the initial recognition, the Company records the debt at amortized cost.
−Removed: The Company expects to satisfy its commitment to the Purchaser prior to the First Hard Cap Date.
+Added: As of December 31, 2024 the Company expects to satisfy its commitment to the Purchaser prior to the Second Hard Cap Date.
+Added: The Company until December 2024 assumed that it would satisfy the commitments to the Purchaser prior to the First Hard Cap Date.
+Added: This change in assumption did not have a material impact on the amount of debt or interest expense recorded for the year ended December 31, 2024.
The Company will record the difference of $ 473.7 million between the total expected payments of $ 843.8 million to the Purchaser and the $ 370.1 million net proceeds as interest expense using the effective interest rate method.
−Removed: The Company determined the effective interest rate based on the projected cash flows up to the First Hard Cap Date.
−Removed: Based on the Company’s projections the effective interest rate is expected to be within a range of 12.0 % to 13.5 % per annum.
−Removed: The Company would have recorded between $ 26.5 million and $ 29.9 million of interest expense during the year ended December 31, 2023 ( nil for the year ended December 31, 2022 and 2021) if it had used effective interest rates of 12.0 % or 13.5 %, instead of the $ 26.9 million recorded in the during the year ended December 31, 2023 ( nil for the year ended December 31, 2022 and 2021).
−Removed: The Company will prospectively update the effective interest rate at each reporting date based on updated projections.
+Added: The Company determined the effective interest rate based on the projected cash flows up to the Second Hard Cap Date.
+Added: Based on the Company’s projections the effective interest rate is expected to be within a range of 12.0 % to 13.5 % per annum, which is consistent with the range that was used prior to the change in assumption in December 2024.
+Added: The Company would have recorded the following amounts:
+Added: Year ended December 31,
+Added: (in millions)
+Added: Interest expenses at effective interest rate of 12.0 % per annum
+Added: Interest recorded in the statement of operations and comprehensive loss and income
+Added: Interest expenses at effective interest rate of 13.5 % per annum
+Added: The Company prospectively updates the effective interest rate at each reporting date based on updated cash flow projections.
The liability was initially recognized at fair value and inputs were considered Level 3 inputs.
−Removed: The following table presents the movement in the liability related to the Royalty Financing Agreement between the closing of the transaction on June 5, 2023 and December 31, 2023:
+Added: The following table presents the movement in the liability related to the Royalty Financing Agreement between the year ended December 31, 2024 and December 31, 2023:
Amount of liability
3 unchanged sentences
Royalty payments to Purchaser
−Removed: Liability owed to the Purchaser (presented as "Accrued expense and other current liabilities")
−Removed: Interest expense for the period June 5, 2023 to December 31, 2023
−Removed: Liability related to the royalty financing agreement
+Added: Interest expense for the period
+Added: Balance as of December 31, 2023 (includes $ 1.4 million presented as "Accrued expenses and other current liabilities)
+Added: Royalty payments to Purchaser
+Added: Interest expense for the period
+Added: Balance as of December 31, 2024 (includes $ 5.0 million presented as "Accrued expenses and other current liabilities)
Retirement benefits
1 unchanged sentence
The Company operates a defined benefit pension plan for its Swiss employees (the “Swiss Plan”) in accordance with local regulations and practices.
−Removed: The normal retirement age under the Swiss Plan is 65 for men and women.
+Added: The normal retirement age under the Swiss Plan is 65 years.
All benefits are immediately vested.
4 unchanged sentences
Participants are also permitted to withdraw a part of the accumulated termination benefit in special circumstances before reaching retirement age for example for payments related to obtain home ownership.
−Removed: The Company recognized its net projected benefit obligation as of December 31, 2023 at a carrying amount of $ 2.5 million, presented within other non-current liabilities in the consolidated balance sheets.
−Removed: The funded status of the Swiss Plan as of December 31, 2023 is as follows:
+Added: The Company initially recognized its net projected benefit obligation as of December 31, 2023 at a carrying amount of CHF 2.1 million ($ 2.6 million), presented within other non-current liabilities in the consolidated balance sheets.
+Added: A summary of the changes in the projected benefit obligation (“PBO”) and plan assets is presented below:
(in thousands)
+Added: Beginning projected benefit obligation
+Added: Interest cost
+Added: Liabilities assumed from participants joining the plan
+Added: Actuarial losses
+Added: Liabilities extinguished through participants leaving the plan
+Added: Foreign currency exchange rate changes
+Added: Ending projected benefit obligation
+Added: (in thousands)
+Added: Beginning fair value of plan assets
+Added: Return on plan assets
+Added: Interest income
+Added: Contributions by the employer
+Added: Assets contributed to the plan from participants joining the plan
+Added: Assets distributed to participants leaving the plan
+Added: Foreign currency exchange rate changes
+Added: Ending fair value of plan assets
+Added: Amounts recognized on the consolidated balance sheet, presented within other non-current liabilities, were as follows:
+Added: (in thousands)
Fair value of plan assets
3 unchanged sentences
Accumulated benefit obligation as of December 31
−Removed: Actuarial losses of $ 2.1 million, net of $ 0.4 million deferred tax income, were recorded in other comprehensive income, net, during the year ended December 31, 2023.
+Added: Amounts recorded in accumulated other comprehensive (income) / loss:
+Added: (in thousands)
+Added: Actuarial loss - beginning of year
+Added: Actuarial (gain) of current year
+Added: Amortization of prior service costs
+Added: Net pension expense related to the defined benefit plans included the following components:
+Added: (in thousands)
+Added: Interest cost
+Added: Interest income
+Added: Amortization of net loss
+Added: Net pension expense
The assumptions related to the Swiss Plan are as follows:
7 unchanged sentences
Future benefits expected to be paid are as follows:
+Added: (in thousands)
Other disclosure items:
5 unchanged sentences
The fair value of the plan assets is determined based on Level 2 inputs.
−Removed: Shareholders’ equity
+Added: Shareholders’ (deficit) / equity
As of December 31, 2024, the Company’s authorized share capital is € 4.0 million (or $ 4.2 million when translated at an exchange rate as of December 31, 2024, of $ 1.04 / €1.00), divided into 80,000,000 ordinary shares, each with a nominal value of € 0.05 .
−Removed: 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.
−Removed: 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.
+Added: The minimum amount of share capital to be held under Dutch law is EUR 0.0 million.
+Added: Under the Company’s Articles of Association, the Company is required to maintain a minimum amount of share capital in reserve.
+Added: In addition, the Company is only permitted to make distributions on its ordinary shares to the extent that its shareholders’ (deficit) / equity exceeds the sum of the paid-up and called-up capital and the reserves it is required to maintain under Dutch law.
+Added: There are no other distribution restrictions applicable to the Company’s shares.
+Added: As the Company’s equity is negative as of December 31, 2024 the Company cannot distribute any equity.
As of December 31, 2024, and 2023 and 2022 the Company’s other comprehensive result was restricted for payment of dividends for an accumulated other comprehensive loss of $ 52.8 million in 2024, an accumulated other comprehensive loss of $ 53.6 million in 2023, and an accumulated other comprehensive loss of $ 58.3 million in 2022.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: During the year ended December 31, 2021, $ 1.3 million of direct, incremental costs were deducted from additional paid-in capital ( nil for the years ended December 31, 2022 and 2023).
−Removed: Following the Closing of the CSL Behring transaction, the Company consumed its tax net operating loss carryforwards from the years 2011 to 2018.
−Removed: 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.
−Removed: This resulted is an increase of additional paid-in capital of $ 3.0 million in the year ended December 31, 2021.
The Company recorded a $ 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
−Removed: Share-based compensation expense recognized by classification included in the consolidated statements of operations and comprehensive (loss) / income was as follows:
+Added: Share-based compensation expense recognized by classification included in the consolidated statements of operations and comprehensive loss was as follows:
Year ended December 31,
18 unchanged sentences
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.
−Removed: 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”).
−Removed: The Company previously had a 2012 Equity Incentive Plan (the “2012 Plan”).
−Removed: As of December 31, 2023, no fully vested share options are outstanding (December 31, 2022:
−Removed: nil ) under the 2012 Plan.
−Removed: At the general meeting of shareholders on January 9, 2014, the Company’s shareholders approved the adoption of the 2014 Plan.
−Removed: 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, 4,000,000 shares in 2021.
−Removed: At an extraordinary general meeting of shareholders in November 2023, an additional 1,750,000 shares were authorized for issuance, increasing the total to 14,351,471 shares.
+Added: The Company’s share-based compensation plans include the 2014 Amended and Restated Share Option Plan as approved by the shareholders in 2014, (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”).
+Added: The shareholders have approved amendment to the 2014 Plan from time to time to increase the shares authorized for issuance.
+Added: At an extraordinary general meeting of shareholders in November 2023, an additional 1,750,000 shares were authorized for issuance.
+Added: At the annual general meeting of shareholders in June 2024, the Company’s shareholders authorized an additional 1,500,000 shares for issuance.
+Added: As of December 31, 2024, a total of 3,912,283 ordinary shares remain available for issuance under the 2014 Plan.
Share options
38 unchanged sentences
3.7 % - 4.8 %
+Added: 2.1 % - 4.2 %
Expected dividend yield
30 unchanged sentences
Non-vested at December 31, 2024
+Added: PSUs awarded but not yet earned
+Added: Total non-vested and discretionary PSUs
Total weighted average grant date fair value of PSUs granted during the period (in $ millions)
−Removed: 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.
−Removed: Earned shares will vest upon the later of a minimum service period of three years , or the achievement of defined milestones, subject to the grantee’s continued employment.
−Removed: 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.
+Added: The Company granted shares to certain employees in September and December 2021 and various dates during the year ended December 31, 2022 and December 31, 2024 that will be earned upon achievement of defined milestones.
+Added: Earned shares vested upon the later of a minimum service period of three years , or the achievement of defined milestones, subject to the grantee’s continued employment.
+Added: In addition, portions of the December 2021 granted to executives and other members of senior management were subject to achieving a minimum total shareholder return relative to the Nasdaq biotechnology index.
+Added: As of December 31, 2024, four milestones had been achieved and vested in either 2022, 2023 or 2024.
+Added: As of December 31, 2024, two milestones were considered probable.
The Company recognizes the compensation cost related to these grants to the extent it considers achievement of the milestones to be probable.
−Removed: As of December 31, 2023, two milestones had been achieved and vested in either 2022 or 2023.
−Removed: Additionally, another two milestones are considered probable as of December 31, 2023.
−Removed: In January 2018 and January and February 2019, the Company awarded PSUs to its executives and other members of senior management.
−Removed: 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.
−Removed: 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.
−Removed: The following table summarizes information about the weighted average grant-date fair value of the PSUs determined as of the date of the grant for the 2021 and 2022 PSUs:
+Added: The Company awarded PSUs to certain employees in December 2024 that will be earned upon the Board of Directors’ (the “Board”) assessment of the level of achievement of agreed upon performance targets through December January 2, 2026
+Added: The following table summarizes information about the weighted average grant-date fair value of the PSUs determined as of the grant date for the years ended December 31:
Weighted average
12 unchanged sentences
As of December 31, 2024, a total of 86,712 ordinary shares remain available for issuance under the ESPP plan.
−Removed: Expenses by nature
−Removed: Operating expenses excluding expenses presented in other expenses included the following expenses by nature:
+Added: Segment reporting
+Added: The Company is advancing a pipeline of innovative gene therapies seeking to deliver to patients suffering from rare and other devastating diseases single treatments with potentially curative results.
+Added: The Company manages the operations related to these research and development activities within one operating segment because they rely on a common set of infrastructure, resources and technology of the products and production processes, types of customers, distribution methods and regulatory environment.
+Added: The leadership team is identified as the CODM.
+Added: The CODM allocates resources to research projects and clinical candidates based on scientific data as well as quantitative and qualitative expected risk adjusted returns on investment.
+Added: The CODM uses segment operating loss to monitor that cash operating losses remain within the approved budget.
+Added: The Company does not evaluate performance or allocate resources based on segment asset data and therefore such information is not presented.
+Added: Refer to Note 8 “ Property, plant and equipment, net ” and Note 9 “ Right-of-use asset and lease liabilities ” for geographic information related to long-lived assets.
+Added: The accounting policies of the operating segment are the same as those described in the summary of significant accounting policies.
Years ended December 31,
2 unchanged sentences
Laboratory and development expenses
−Removed: Office and housing expenses
−Removed: Legal and advisory expenses
−Removed: Fair value loss - uniQure France SAS contingent consideration
−Removed: Other operating expenses
−Removed: Depreciation and amortization expenses
−Removed: Patent and license expenses
−Removed: Impairment related to the Reorganization
−Removed: Details of employee-related expenses for the years ended December 31 are as follows:
+Added: Professional fees
+Added: Facility expenses
+Added: Other segment items (a) (b)
+Added: Segment operating loss
+Added: Reconciliation
+Added: Depreciation, amortization and impairment expense
+Added: Share-based compensation expense
+Added: Fair value gain / (loss) - contingent consideration and derivative financial instrument
+Added: Foreign currency (losses) / gains, net
+Added: Interest income
+Added: Interest expense - Royalty Financing Agreement
+Added: Interest expense - Hercules debt facility
+Added: Other reconciling items (c) (d)
+Added: Consolidated loss before income tax (expense) / benefit
+Added: (a) Other segments items included in segment operating loss include costs related to intellectual property, information technology and insurance offset by income related to payments received from European authorities to subsidize the Company’s research and development in the Netherlands and France.
+Added: (b) For the year ended December 31, 2023, other segment items include $ 10.0 million related to the upfront consideration paid to Apic Bio for the global licensing agreement for AMT-162.
+Added: (c) For the year ended December 31, 2024, other reconciling items include costs related to the divestment of the Company’s commercial manufacturing activities and the August 2024 reorganization.
+Added: (d) For the year ended December 31, 2023, other reconciling items include costs related to the October 2023 reorganization and professional fees related to the Apic Bio transaction.
+Added: Collaboration arrangements and concentration of credit risk
+Added: Revenues recorded for the years ended December 31, are as follows:
Years ended December 31,
(in thousands)
−Removed: Wages and salaries
−Removed: Share-based compensation expenses
−Removed: Contractor expenses
−Removed: Social security costs
−Removed: Health insurance
−Removed: Costs related to pension plans
−Removed: Severance costs related to the Reorganization (refer to Note 4 " Reorganization ")
−Removed: Other employee expenses
−Removed: Other income during the year ended December 31, 2023 was $ 6.1 million compared to $ 7.2 million and $ 12.3 million during the same periods in 2022 and 2021, respectively.
−Removed: Other income in 2023, 2022 and 2021 includes income from payments received from European authorities to subsidize the Company’s research and development efforts in the Netherlands.
−Removed: The amount recognized in the year ended December 31, 2023 was $ 5.0 million compared to $ 5.6 million in 2022 and $ 5.3 million in 2021.
−Removed: In addition, other income included $ 2.6 million of employee retention credits received under the U.S.
−Removed: Coronavirus Aid, Relief, and Economic Security Act, during the year ended December 31, 2021.
−Removed: No such income was received in the years ended December 31, 2023 or December 31, 2022.
−Removed: 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.
−Removed: in conjunction with a settlement agreement that the Company and VectorY B.V.
−Removed: entered into in April 2021.
−Removed: In the year ended December 31, 2023 and 2022, the Company recognized nil and $ 0.3 million, respectively, of other income related to the equity stake received in VectorY.
−Removed: In 2023, 2022 and 2021 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.
+Added: License revenue (royalty payments) from CSL Behring
+Added: License revenue (milestone payments) from CSL Behring
+Added: Contract manufacturing revenue from CSL Behring
+Added: Collaboration revenue from CSL Behring
+Added: Collaboration revenue from BMS
+Added: License revenue (milestone payments) from CSL Behring
+Added: The Company recorded $ 100.0 million in variable milestone revenue related to a first sale of HEMGENIX ® in the U.S.
+Added: during the year ended December 31, 2022 as the Company considered the occurrence of this event to be probable following the November 2022 BLA approval of HEMGENIX ® .
+Added: The Company collected the $ 100.0 million payment from CSL Behring in July 2023 following the first sale of the Product in the U.S in June 2023.
+Added: Contract manufacturing revenue from CSL Behring
+Added: The Company provided contract manufacturing services to CSL Behring from April 2022 until the July 2024 divestment of the commercial manufacturing activities to Genezen.
+Added: Following the Closing of the Lexington Transaction, title to HEMGENIX® supply directly passes from the contract manufacturer, Genezen, to CSL Behring.
+Added: The Company does not control HEMGENIX® before it is transferred to CSL Behring.
+Added: The Company arranges for HEMGENIX® to be provided by Genezen to CSL Behring.
+Added: The Company determined that it is an agent in the sale of HEMGENIX® to CSL Behring.
+Added: The Company’s development and commercial supply agreement requires the Company to supply HEMGENIX ® to CSL Behring until such time that these capabilities are transferred to CSL Behring or a contract manufacturing organization designated by CSL Behring.
+Added: On September 6, 2022, CSL Behring notified the Company of its intent to transfer manufacturing technology related to HEMGENIX ® in the coming years to a third-party contract manufacturer designated by CSL Behring.
+Added: The Company generated $ 6.1 million, $ 10.8 million and $ 1.7 million contract manufacturing revenue from sales to CSL Behring during the years ended December 31, 2024, 2023 and 2022.
+Added: The Company incurred $ 17.1 million, $ 13.6 million and $ 2.1 million of costs in relation to its contract manufacturing activities during the years ended December 2024, 2023 and 2022.
+Added: As a result of the Company being an agent, the Company recognizes corresponding costs related to the purchase of HEMGENIX® from Genezen net of income from the sales of HEMGENIX® to CSL Behring as well as income related to the release of liabilities associated with expected net losses in Other expense within the Company’s Consolidated Statements of Operations and Comprehensive Loss.
+Added: Collaboration revenue from CSL Behring
+Added: The Company provides on-demand development services and other services to CSL Behring.
+Added: These activities are reimbursed at an agreed full-time-employee rate and CSL Behring also reimbursed agreed third-party expenses incurred in relation to performing these activities.
+Added: The Company recognized $ 10.9 million of collaboration revenue in the year ended December 31, 2024, compared to $ 2.3 million and $ 3.0 million in the same periods in 2023 and 2022.
+Added: Accounts r eceivable
+Added: As of December 31, 2024, the Company had accounts receivable of $ 5.7 million related to collaboration services and royalty revenue.
+Added: As of December 31, 2023, the Company recorded accounts receivable of $ 4.0 million from CSL Behring related to collaboration services, contract manufacturing revenue and royalty revenue.
+Added: Other income during the year ended December 31, 2024 was $ 7.9 million compared to $ 6.1 million and $ 7.2 million during the same periods in 2023 and 2022.
+Added: Years ended December 31,
+Added: (in thousands)
+Added: Research and development grants from Dutch and French authorities
+Added: Gain on sale of commercial manufacturing facility
+Added: Sublease income
+Added: Other expense
+Added: Other expense during the year ended December 31, 2024 was $ 4.6 million compared to $ 1.7 million and $ 0.8 million during the same periods in 2023 and 2022, respectively.
+Added: Years ended December 31,
+Added: (in thousands)
+Added: Supply of HEMGENIX® to CSL Behring
+Added: Sublease expense
+Added: Fair value loss related to equity stake in VectorY B.V.
+Added: In the year ended December 31, 2024, the Company recognized $ 3.2 million net ( nil in periods ended December 31, 2023 and 2022) in other expense related to the purchase of HEMGENIX® from Genezen net of income from the sales of HEMGENIX® to CSL Behring, amortization of the intangible asset for the favorable supply terms under the CSA and credits from the release of liabilities related to expected net losses associated with the minimum purchase commitments under the CSA.
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 and a partial valuation allowance against the Company’s net deferred tax assets in France.
−Removed: In connection with the acquisition of uniQure France SAS, 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, 2024 and 2023.
13 unchanged sentences
Tax benefit recognized in other comprehensive income
−Removed: The reconciliation of the amount of income tax benefit recognized in other comprehensive income for the year ended December 31, 2023 is as follows:
+Added: The reconciliation of the amount of income tax (loss) / benefit recognized in Other comprehensive income / (loss) for the years ended December 31, 2024 and December 31, 2023 is as follows:
Year ended December 31, 2024
+Added: Year ended December 31, 2023
(in thousands)
−Removed: Unrecognized gain related to defined benefit pension plan liability
−Removed: No income tax benefit or expense has been recognized in Other Comprehensive Income for the years ended December 31, 2022 and 2021.
+Added: (in thousands)
+Added: Unrecognized (loss) / gain related to defined benefit pension plan liability
+Added: No income tax benefit or expense has been recognized in Other Comprehensive Loss for the year ended December 31, 2022.
Tax rate reconciliation
−Removed: The reconciliation of the amount of income tax (expense) / benefit that would result from applying the Dutch statutory income tax rate to the Company’s reported amount of (loss) / income before income tax (expense) / benefit for the years ended December 31, 2023, 2022 and 2021, is as follows:
+Added: The reconciliation of the amount of income tax (expense) / benefit that would result from applying the Dutch statutory income tax rate to the Company’s reported amount of loss before income tax (expense) / benefit for the years ended December 31, 2024, 2023 and 2022, is as follows:
Years ended December 31,
(in thousands)
−Removed: (Loss) / income before income tax (expense) / benefit for the period
−Removed: Expected income tax benefit / (expense) at the tax rate enacted in the Netherlands (2023:
−Removed: 25.8 %, 2022:
−Removed: 25.8 %, 2021:
−Removed: Difference in tax rates between the Netherlands and the U.S.
−Removed: as well as other foreign countries
+Added: Loss before income tax (expense) / benefit for the period
+Added: Expected income tax benefit at the 25.8 % tax rate enacted in the Netherlands
+Added: Difference in tax rates between the Netherlands and other foreign countries
Other net change in valuation allowance
5 unchanged sentences
$ 8.5 million).
−Removed: The fair value loss on contingent consideration affected the effective tax rate by an amount of $ 4.1 million in 2023 ($ 1.9 million and $ 2.0 million in 2022 and 2021, respectively).
+Added: The fair value gain on contingent consideration affected the effective tax rate by an amount of $ 0.5 million in 2024 ($ 4.1 million and $ 1.9 million in 2023 and 2022, respectively).
Significant components of deferred taxes
4 unchanged sentences
Net operating loss carryforwards
−Removed: Operating lease liabilities
−Removed: Intangible assets
Liability from Royalty Financing agreement
−Removed: Interest carryforwards
+Added: Operating lease liabilities
Accrued expenses and other current liabilities
−Removed: Defined benefit pension plan liability
+Added: Interest carryforwards
Property, plant and equipment
−Removed: Research and development tax credit carryforwards
+Added: Defined benefit pension plan liability
Total deferred tax assets
12 unchanged sentences
Changes recorded in equity
−Removed: Increase related to 2021 Dutch tax reforms
−Removed: Valuation allowance assumed in uniQure France SAS acquisition
Other changes including currency translation adjustments
−Removed: The valuation allowance as of December 31, of $ 145.2 million as of December 31,2023 is primarily related to $ 142.4 million deferred tax assets in the Netherlands resulting from net operating loss carryforwards of $ 127.1 million, intangibles assets of $ 5.5 million, liability from Royalty Financing Agreement of $ 6.2 million and interest carryforwards of $ 3.7 million.
−Removed: As of December 31, 2023, the total amount of net operating losses carried forward under the Dutch tax regime was $ 492.7 million (December 31, 2022:
−Removed: $ 264.0 million, 2021:
−Removed: $ 228.5 million).
+Added: The valuation allowance of $ 191.9 million as of December 31, 2024 is primarily related to EUR 178.7 million ($ 185.6 million) deferred tax assets in the Netherlands resulting from net operating loss carryforwards of EUR 153.1 million ($ 159.1 million), liability from Royalty Financing Agreement of EUR 18.8 million ( $ 19.5 million), intangible assets of EUR 3.6 million ($ 3.8 million), interest carryforwards of EUR 2.8 million ($ 3.0 million) and property, plant and equipment of EUR 0.4 million ($ 0.4 million).
+Added: As of December 31, 2024, the total amount of net operating losses carried forward under the Dutch tax regime was EUR 593.6 million ($ 616.5 million) (December 31, 2023:
+Added: EUR 446.4 million ($ 492.7 million)).
The Company has historically recorded a full valuation allowance.
1 unchanged sentence
Management considers reversing taxable temporary differences, projected future taxable income and tax-planning strategies in making this assessment.
−Removed: The Company concluded that as of December 31, 2023, December 31, 2022 and December 31, 2021 it is more likely than not that the remaining deferred tax assets will not be realized.
−Removed: As of December 31, 2023, the tax treatment of the Royalty Agreement has not yet been agreed with the Dutch tax authorities.
+Added: The Company concluded that as of December 31, 2024, and December 31, 2023 it is more likely than not that the remaining deferred tax assets will not be realized.
+Added: The Company’s Dutch net operating tax losses carried forward relate to 2019, 2022, 2023 and 2024.
+Added: As of December 31, 2024, the tax treatment of the Royalty Agreement has not been agreed with the Dutch tax authorities.
A different tax treatment could result in a different categorization of temporary differences and an offsetting deferred tax asset.
−Removed: The Company recorded $ 462.4 million of license revenue in May 2021 after the Closing of the CSL Behring transaction.
−Removed: 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.
−Removed: 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.
−Removed: The Company’s remaining Dutch net operating tax losses carried forward relate to 2019, 2022 and 2023.
−Removed: 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.
−Removed: 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.
−Removed: 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, 2024 continues to relate to follow-on offering costs incurred in 2019.
Any subsequently recognized tax benefits will be credited directly to contributed capital.
−Removed: As of December 31, 2023, that amount was $ 3.4 million ($ 3.3 million as of December 31, 2022).
−Removed: The Dutch corporate tax rate for fiscal year 2021 was 25.0 %.
−Removed: In December 2021, changes were enacted that raised the corporate income tax rate from 25.0 % to 25.8 % from 2022 onwards.
−Removed: 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.
+Added: As of December 31, 2024, that amount was EUR 3.0 million ($ 3.2 million) and EUR 3.0 million ($ 3.4 million) as of December 31, 2023.
+Added: The Dutch corporate tax rate is 25.8 % from 2022 onwards.
+Added: 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 can be carried forward indefinitely.
The fiscal periods from 2022 onwards are still open for inspection by the Dutch tax authorities.
5 unchanged sentences
The Company’s U.S.
−Removed: operations generated taxable income in the fiscal years 2018 to 2021 and 2023.
+Added: operations have been generating taxable income since 2018 with the exception of 2022.
The Company expects to continue to generate taxable income in the U.S.
11 unchanged sentences
The Company’s French operations have incurred losses since incorporation and are expected to continue incurring tax losses for the foreseeable future.
−Removed: The French operations as of December 31, 2023 have an estimated $ 39.6 million ($ 23.3 million as of December 31, 2022) of net operating losses that are available for carry forward indefinitely.
−Removed: The Company recorded a partial valuation allowance during the year ended December 31, 2023.
−Removed: No such valuation allowance was recorded in the years ended December 31, 2022 and 2021.
−Removed: The Company evaluates all positive and negative evidence including future income from reversing taxable temporary differences (particularly from reversing the deferred tax liability related to the acquired IPR&D intangible asset), projected future taxable income and tax-planning strategies in making this assessment.
−Removed: Basic and diluted earnings per share
−Removed: 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.
+Added: The French operations as of December 31, 2024 have an estimated EUR 48.9 million ($ 50.8 million) (December 31, 2023:
+Added: EUR 35.9 million ($ 39.6 million)) of net operating losses that are available for carry forward indefinitely.
+Added: The Company recorded a partial valuation allowance during the years ended December 31, 2024 and 2023.
+Added: No such valuation allowance was recorded in the years ended December 31, 2022 or 2021.
+Added: The Company evaluates all positive and negative evidence including future income from reversing taxable temporary differences (particularly from reversing the deferred tax liability related to the acquired IPR&D intangible asset), projected future taxable income subject to the loss limitation rules applicable in France and tax-planning strategies in making this assessment.
+Added: Basic and diluted earnings per ordinary share
+Added: Basic net loss per ordinary share is computed by dividing net loss 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.
−Removed: For the year ended December 31, 2021, dilutive net income / (loss) per ordinary share is computed using the treasury method.
−Removed: As the Company has incurred a loss in the years ended December 31, 2023 and December 31, 2022, 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, 2023 and December 31, 2022.
+Added: As the Company has incurred a loss in the years presented, 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.
Year ended December 31,
1 unchanged sentence
share amounts)
−Removed: Net (loss) / income attributable to ordinary shares
−Removed: Weighted-average number of ordinary shares outstanding - basic
−Removed: Stock options under 2014 Plans and previous plan
−Removed: Non-vested RSUs and PSUs
−Removed: Employee share purchase plan
−Removed: Weighted-average number of ordinary shares outstanding - diluted
−Removed: 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, 2023, 2022 and 2021 as the effect of their inclusion would have been anti-dilutive:
+Added: Net loss attributable to ordinary shares
+Added: Weighted-average number of ordinary shares outstanding - basic and diluted
+Added: The following table presents ordinary share equivalents that were excluded from the calculation of diluted net loss per ordinary share for the years presented as the effect of their inclusion would have been anti-dilutive:
Year ended December 31,
3 unchanged sentences
Total anti-dilutive ordinary share equivalents
−Removed: 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, 2023 and December 31, 2022.
+Added: 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, 2024, December 31, 2023 and December 31, 2022.
Commitments and contingencies
4 unchanged sentences
The achievement and timing of these milestones is not fixed and determinable.
−Removed: Relevant commitments and contingencies are further discussed in other sections of this form 10-K, such as, Note 3 “ uniQure France SAS transaction ” and Note 5 “ Collaboration arrangements and concentration of credit risk ”, amongst others.
+Added: Relevant commitments and contingencies are further discussed in other sections of this form 10-K, such as, Note 3 “ Divestiture of manufacturing facility ” and Note 18 “ Collaboration arrangements and concentration of credit risk ”, amongst others.
Related party transaction
Subsequent events
+Added: In January 2025, the Company received net proceeds of $ 70.1 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company, through a follow-on public offering of 4.4 million ordinary shares at a public offering price of $ 17.00 per ordinary share.
+Added: In February 2025, the Company received an additional $ 10.6 million in net proceeds upon the underwriters’ exercise of their option to purchase an additional 0.7 million ordinary shares at the public offering price.
EXHIBIT INDEX
7 unchanged sentences
333-225629) filed with the SEC on June 14, 2018).
−Removed: Employment Agreement dated December 9, 2014 between uniQure, Inc.
−Removed: and Matthew Kapusta (incorporated by reference to Exhibit 10.6 of the Company's annual report on Form 10-K (file no.
+Added: Amended and Restated 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K (file no.
+Added: 001-36294) filed with the SEC on November 17, 2023).
+Added: Amended and Restated 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K (file no.
+Added: 001-36294) filed with the SEC on June 20, 2024).
+Added: Form of Share Option Agreement, effective December 8, 2021, under the 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.65 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (file no.
+Added: 001-36294) filed with the SEC on February 25, 2022).
+Added: Form of Restricted Stock Unit Award, effective December 8, 2021, under the 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.66 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (file no.
+Added: 001-36294) filed with the SEC on February 25, 2022).
+Added: Form of Performance Stock Unit Award, effective December 8, 2021 under the 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.67 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (file no.
+Added: 001-36294) filed with the SEC on February 25, 2022).
+Added: Employee Share Purchase Plan (incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S-8 (file no.
+Added: 333-225629) filed with the SEC on June 14, 2018).
+Added: Employment Agreement between uniQure, Inc.
+Added: and Matthew Kapusta, dated December 9, 2014 (incorporated by reference to Exhibit 10.6 of the Company's Annual Report on Form 10-K (file no.
001-36294) for the year ended December 31, 2016 filed with the SEC on March 15, 2017).
5 unchanged sentences
001-36294) for the period ended September 30, 2017 filed with the SEC on November 1, 2017).
+Added: Amended and Restated Employment Agreement, effective June 15, 2021, by and between uniQure biopharma B.V.
+Added: and Christian Klemt (incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q (file no.
+Added: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
+Added: Employment Agreement, effective May 17, 2021, by and between uniQure biopharma B.V.
+Added: and Pierre Caloz (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q (file no.
+Added: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
+Added: Equity Side Letter, effective May 17, 2021, by and between uniQure N.V.
+Added: and Pierre Caloz (incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q (file no.
+Added: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
+Added: Termination Agreement, dated July 22, 2024, by and between uniQure biopharma B.V.
+Added: and Pierre Caloz (incorporated by reference to Exhibit 10.5 of the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2024 (file no.
+Added: 001-36294) filed with the SEC on August 1, 2024).
+Added: Employment Agreement dated June 13, 2023 between uniQure, Inc.
+Added: and Jeannette Potts (incorporated by reference to Exhibit 10.77 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (file no.
+Added: 001-36294) filed with the SEC on February 28, 2024).
+Added: Employment Agreement dated June 26, 2023 between Corlieve Therapeutics AG and Walid Abi-Saab.
Lease relating to 113 Hartwell Avenue, Lexington, Massachusetts, dated as of July 24, 2013, by and between uniQure Inc.
1 unchanged sentence
333-193158) filed with the SEC on January 2, 2014).
+Added: First Amendment Lease relating to 113 Hartwell Avenue, Lexington, Massachusetts, dated as of July 24, 2013, by and between the Company and King113 Hartwell LLC (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K (file no.
+Added: 001-36294) filed with the SEC on November 15, 2018).
+Added: Second Amendment Lease relating to 113 Hartwell Avenue, Lexington Massachusetts, dated as of June 17, 2019, by and between the Company and King 113 Hartwell LLC (incorporated by reference to Exhibit 10.42 of the Company’s Quarterly Report on Form 10-Q (file no.
+Added: 001-36294) for the period ended June 30, 2019 filed with the SEC on July 29, 2019).
+Added: Landlord Consent to Assignment and Assumption of Lease and Third Amendment to Lease, dated June 28, 2024, by and among Hartwell Innovation Campus, LLC, uniQure, Inc.
+Added: and Genezen MA, Inc.
+Added: (incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q (file no.
+Added: 001-36294) for the period ending June 30, 2024 filed with the SEC on August 1, 2024).
+Added: Assignment and Assumption of Lease, dated July 22, 2024, by and between uniQure, Inc.
+Added: and Genezen MA, Inc.
+Added: (incorporated by reference to Exhibit 10.4 of the Company’s Quarterly Report on Form 10-Q (file no.
+Added: 001-36294) for the period ending June 30, 2024 filed with the SEC on August 1, 2024).
+Added: Lease relating to Paasheuvelweg 25, dated as of March 7, 2016, by and between 52 IFH GmbH & Co.
+Added: KG and uniQure biopharma B.V.
+Added: (incorporated by reference to Exhibit 10.36 of the Company’s Annual Report on Form 10-K (file no.
+Added: 001-36294) for the year ended December 31, 2016 filed with the SEC on March 15, 2017).
+Added: Lease Agreement relating to 91 Hartwell Avenue, Lexington, Massachusetts, dated as of February 1, 2022, by and between uniQure Inc.
+Added: and NRL 91 Hartwell LLC (incorporated by reference to Exhibit 10.70 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (file no.
+Added: 001-36294) filed with the SEC on February 25, 2022).
+Added: Lease Agreement relating to Peter Merian-Weg 4, 4052 Basel, Switzerland, dated as of November 1, 2023, by and between Corlieve Therapeutics AG and Stiftung Sympany.
Business Acquisition Agreement, dated as of February 16, 2012, by and among Amsterdam Molecular Therapeutics (AMT) Holding N.V., the Company and the other Parties listed therein (incorporated by reference to Exhibit 10.29 of the Company’s Registration Statement on Form F-1 (file no.
8 unchanged sentences
333-193158) filed with the SEC on January 2, 2014).
−Removed: Investor Agreement by and between uniQure Biopharma B.V.
−Removed: and Bristol-Myers Squibb Company dated April 6, 2015 (incorporated by reference to Exhibit 4.32 of the Company's annual report on Form 20-F for the year ended December 31, 2014 (file no.
−Removed: 001-36294) filed with the SEC on April 7, 2015).
−Removed: Lease relating to Paasheuvelweg 25, dated as of March 7, 2016, by and between 52 IFH GmbH & Co.
−Removed: KG and uniQure biopharma B.V.
−Removed: (incorporated by reference to Exhibit 10.36 of the Company's annual report on Form 10-K (file no.
−Removed: 001-36294) for the year ended December 31, 2016 filed with the SEC on March 15, 2017).
Assignment and License Agreement dated April 17, 2017 between Professor Paolo Simioni and uniQure biopharma B.V.
1 unchanged sentence
001-36294) filed with the SEC on October 19, 2017).
−Removed: First Amendment Lease relating to 113 Hartwell Avenue, Lexington, Massachusetts, dated as of July 24, 2013, by and between the Company and King113 Hartwell LLC (incorporated by reference to Exhibit 10.1 of the Company's current report on form 8-K (file no.
−Removed: 001-36294) filed with the SEC on November 15, 2018).
−Removed: Employee Share Purchase Plan (incorporated by reference to Exhibit 4.2 of the Company's registration statement on Form S-8 (file no.
−Removed: 333-225629) filed with the SEC on June 14, 2018).
−Removed: Second Amendment Lease relating to 113 Hartwell Avenue, Lexington Massachusetts, dated as of June 17, 2019, by and between the Company and King 113 Hartwell LLC (incorporated by reference to Exhibit 10.42 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ended June 30, 2019 filed with the SEC on July 29, 2019).
Commercialization and License Agreement by and between uniQure biopharma B.V.
1 unchanged sentence
001-36294) for the period ended June 30, 2020 filed with the SEC on July 30, 2020).
−Removed: Employment Agreement, executed September 14, 2020, by and between uniQure Inc.
−Removed: and Ricardo Dolmetsch (incorporated by reference to Exhibit 10.3 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ended September 30, 2020 filed with the SEC on October 27, 2020).
−Removed: Amended and Restated 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K (file no.
−Removed: 001-36294) filed with the SEC on November 17, 2023).
−Removed: Employment Agreement, effective May 17, 2021, by and between uniQure biopharma B.V.
−Removed: and Pierre Caloz (incorporated by reference to Exhibit 10.1 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
−Removed: Equity Side Letter, effective May 17, 2021, by and between uniQure N.V.
−Removed: and Pierre Caloz (incorporated by reference to Exhibit 10.2 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
−Removed: Amended and Restated Employment Agreement, effective June 15, 2021, by and between uniQure biopharma B.V.
−Removed: and Christian Klemt (incorporated by reference to Exhibit 10.3 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
−Removed: Form of Share Option Agreement, effective December 8, 2021, under the 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.65 of the Company’s annual report on Form 10-K for the year ended December 31, 2021 (file no.
−Removed: 001-36294) filed with the SEC on February 25, 2022).
−Removed: Form of Restricted Stock Unit Award, effective December 8, 2021, under the 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.66 of the Company’s annual report on Form 10-K for the year ended December 31, 2021 (file no.
−Removed: 001-36294) filed with the SEC on February 25, 2022).
−Removed: Form of Performance Stock Unit Award, effective December 8, 2021 under the 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.67 of the Company’s annual report on Form 10-K for the year ended December 31, 2021 (file no.
−Removed: 001-36294) filed with the SEC on February 25, 2022).
Third Amended and Restated Loan and Security Agreement as of December 15, 2021, by and among uniQure biopharma B.V., uniQure Inc., uniQure IP B.V., the Company and Hercules Capital Inc (incorporated by reference to Exhibit 10.68 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (file no.
001-36294) filed with the SEC on February 25, 2022).
−Removed: Lease Agreement relating to 20 Maguire Road, Lexington, Massachusetts, dated as of December 22, 2021, by and between uniQure Inc.
−Removed: and G&I IX/GP4 20 Maguire LLC (incorporated by reference to Exhibit 10.69 of the Company’s annual report on Form 10-K for the year ended December 31, 2021 (file no.
−Removed: 001-36294) filed with the SEC on February 25, 2022).
−Removed: Lease Agreement relating to 91 Hartwell Avenue, Lexington, Massachusetts, dated as of February 1, 2022, by and between uniQure Inc.
−Removed: and NRL 91 Hartwell LLC (incorporated by reference to Exhibit 10.70 of the Company’s annual report on Form 10-K for the year ended December 31, 2021 (file no.
−Removed: 001-36294) filed with the SEC on February 25, 2022).
Amendment No.
2 unchanged sentences
001-36294) filed with the SEC on August 1, 2023).
+Added: Consent and Amendment No.
+Added: 2 to Third Amended and Restated Loan and Security Agreement, dated June 28, 2024, by and among uniQure biopharma B.V., uniQure, Inc., uniQure IP B.V., the Company and Hercules Capital, Inc.
+Added: (incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2024 (file no.
+Added: 001-36294) filed with the SEC on August 1, 2024).
Royalty Purchase Agreement, dated May 12, 2023, by and between uniQure biopharma B.V.
2 unchanged sentences
001-36294) filed with the SEC on August 1, 2023).
−Removed: Termination and Consulting Agreement, effective October 4, 2023, by and between uniQure Inc.
−Removed: and Ricardo Dolmetsch, Ph.D.
−Removed: (incorporated by reference to Exhibit 10.1 of the Company’s quarterly report on Form 10-Q for the period ended September 30, 2023 (file no.
−Removed: 001-36294) filed with the SEC on November 7, 2023).
−Removed: Employment Agreement dated July 30, 2021 between Corlieve Therapeutics AG and Richard Porter.
−Removed: First Amended Employment Agreement dated April 1, 2022 between Corlieve Therapeutics AG and Richard Porter.
−Removed: Letter Agreement dated October 5, 2023, by and between Richard Porter and Corlieve Therapeutics AG.
−Removed: Employment Agreement dated June 13, 2023 between uniQure, Inc.
−Removed: and Jeannette Potts.
+Added: Asset Purchase Agreement, by and among uniQure, Inc., uniQure biopharma B.V., Genezen Holdings Inc.
+Added: and Genezen MA, Inc., dated as of June 29, 2024 (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2024 (file no.
+Added: 001-36294) filed with the SEC on August 1, 2024).
Code of Ethics.
+Added: Insider Trading Policy.
Subsidiaries of the Company.
5 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
−Removed: Compensation Clawback Policy.
+Added: Compensation Clawback Policy (incorporated by reference to Exhibit 97.1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (file no.
+Added: 001-36294) filed with the SEC on February 28, 2024).
The following materials from the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, formatted in Inline XBRL (eXtensible Business Reporting Language):
−Removed: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations and Comprehensive Income (Loss), (iii) Consolidated Statements of Shareholders’ Equity, (iv) Consolidated Statements of Cash Flows and (v) Notes to Consolidated Financial Statements.
+Added: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations and Comprehensive Income (Loss), (iii) Consolidated Statements of Shareholders’ (Deficit) / Equity, (iv) Consolidated Statements of Cash Flows and (v) Notes to Consolidated Financial Statements.
The cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 has been formatted in Inline XBRL.
1 unchanged sentence
Filed herewith.
+Added: ** Furnished herewith.
Indicates a management contract or compensatory plan or arrangement.
33 unchanged sentences
February 27, 2025
−Removed: /s/ PAULA SOTEROPOULOS
−Removed: February 28, 2024
−Removed: Paula Soteropoulos
/s/ JEREMY P.
1 unchanged sentence
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.