27 unchanged sentences
Other Information
+Added: Trading Arrangements
+Added: During the three months ended December 31, 2023, 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.
+Added: Amendments to Code of Ethics
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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 regarding our directors, executive directors and corporate governance is incorporated into this section by reference to our Proxy Statement for our 2023 Annual Meeting of Shareholders or will be included in an amendment to this Annual Report on Form 10-K.
+Added: 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.
Executive Compensation
−Removed: The information required by this Item regarding executive compensation is incorporated into this section by reference to our Proxy Statement for our 2023 Annual Meeting of Shareholders or will be included in an amendment to this Annual Report on Form 10-K.
+Added: 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.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
−Removed: The information required by this Item regarding security ownership of certain beneficial owners, management and related stockholder matters, our equity compensation plans and securities under our equity compensation plans, is incorporated into this section by reference to our Proxy Statement for our 2023 Annual Meeting of Shareholders or will be included in an amendment to this Annual Report on Form 10-K.
+Added: 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.
Certain Relationships and Related Transactions, and Director Independence
−Removed: The information required by this Item regarding certain relationships and related transactions and director independence is incorporated into this section by reference to our Proxy Statement for our 2023 Annual Meeting of Shareholders or will be included in an amendment to this Annual Report on Form 10-K.
+Added: 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.
Principal Accounting Fees and Services
−Removed: The information required by this Item regarding our principal accountant fees and services is incorporated into this section by reference to our Proxy Statement for our 2023 Annual Meeting of Shareholders or will be included in an amendment to this Annual Report on Form 10-K.
+Added: 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.
Exhibits, Financial Statements Schedules
68 unchanged sentences
Accounts receivable and contract asset
+Added: Inventories, net
Prepaid expenses
17 unchanged sentences
Long-term debt
+Added: Liability from royalty financing agreement
Operating lease liabilities, net of current portion
14 unchanged sentences
The accompanying notes are an integral part of these consolidated financial statements.
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS AND INCOME
Year ended December 31,
1 unchanged sentence
License revenues
−Removed: License revenues from related parties
Contract manufacturing revenues
Collaboration revenues
−Removed: Collaboration revenues from related parties
Total revenues
9 unchanged sentences
Interest expense
−Removed: Foreign currency gains / (losses), net
+Added: Foreign currency (losses) / gains, net
Other non-operating gains / (losses), net
−Removed: (Loss) / income before income tax benefit / (expense)
−Removed: Income tax benefit / (expense)
+Added: (Loss) / income before income tax (expense) / benefit
+Added: Income tax (expense) / benefit
Net (loss) / income
−Removed: Other comprehensive loss:
−Removed: Foreign currency translation adjustments
−Removed: Total comprehensive (loss) / gain
+Added: Other comprehensive income / (loss):
+Added: Foreign currency translation gains / (losses), net
+Added: Defined benefit pension loss, net of taxes
+Added: Total comprehensive (loss) / income
Earnings per ordinary share - basic
12 unchanged sentences
Balance at December 31, 2020
−Removed: Loss for the period
−Removed: Other comprehensive income
+Added: Income for the period
+Added: Other comprehensive loss
+Added: Issuance of ordinary shares
+Added: Income tax benefit of past share issuance cost
Exercises of share options
3 unchanged sentences
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
−Removed: Exercise of share options
+Added: Other comprehensive income, net
+Added: Exercises of share options
Restricted and performance share units distributed during the period
9 unchanged sentences
Adjustments to reconcile net (loss) / income to net cash (used in) / generated from operating activities:
−Removed: Depreciation and amortization expense
+Added: Depreciation, amortization and impairment
+Added: Amortization of premium/discount on investment securities
Share-based compensation expense
−Removed: Deferred tax (income) / expense
+Added: Royalty financing agreement interest expense
+Added: Deferred tax expense / (income)
Changes in fair value of contingent consideration and derivative financial instrument, net
−Removed: Unrealized foreign exchange (gains) / losses, net
−Removed: Change in deferred revenue
−Removed: Other non-cash items, net
+Added: Unrealized foreign exchange gains, net
+Added: Other items, net
Changes in operating assets and liabilities:
3 unchanged sentences
Accrued expenses, other liabilities, and operating leases
+Added: Contingent consideration milestone payment
Net cash (used in) / generated from operating activities
Cash flows from investing activities
−Removed: Investment in investment securities
+Added: Investment in debt securities
+Added: Proceeds on maturity of debt securities
Purchases of property, plant, and equipment
−Removed: Acquisition of Corlieve, net of cash acquired
−Removed: Purchases of intangible assets
+Added: Acquisition of uniQure France SAS, net of cash acquired
Net cash used in investing activities
Cash flows from financing activities
−Removed: Proceeds from issuance of ordinary shares related to employee stock option and purchase plans
−Removed: Proceeds from loan increment, net of debt issuance costs
Proceeds from issuance of ordinary shares
Share issuance costs from issuance of ordinary shares
−Removed: Repayment of debt acquired through acquisition of Corlieve
+Added: Proceeds from royalty financing agreement
+Added: Payment of debt issuance costs
+Added: Repayment of debt acquired through acquisition of uniQure France SAS
+Added: Proceeds from loan increment, net of debt issuance costs
+Added: Proceeds from issuance of ordinary shares related to employee stock option and purchase plans
+Added: Contingent consideration milestone payment
Net cash generated from financing activities
Currency effect on cash, cash equivalents and restricted cash
−Removed: Net (decrease) / increase in cash, cash equivalents and restricted cash
+Added: Net increase / (decrease) in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash at beginning of period
5 unchanged sentences
Cash paid for interest
−Removed: Non-cash (decrease) / increase in accounts payables and accrued expenses and other current liabilities related to purchases of property, plant, and equipment
+Added: Non-cash decrease in accounts payables and accrued expenses and other current liabilities related to purchases of property, plant, and equipment
The accompanying notes are an integral part of these consolidated financial statements.
26 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 Corlieve Therapeutics SAS (“Corlieve”), the treatment of revenue to be recognized under the commercialization and license agreement entered into (“CSL Behring Agreement”) between the Company and CSL Behring LLC (“CSL Behring”), and the assessment of a valuation allowance on the Company’s deferred tax assets in the Netherlands and the U.S.
+Added: 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.
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.
46 unchanged sentences
Items measured at fair value on a recurring basis include financial instruments and contingent consideration (Note 7, “ Fair value measurement ”).
−Removed: The carrying amount of cash and cash equivalents, accounts receivable from collaborators, prepaid expenses, other assets, accounts payable, accrued expenses and other current liabilities reflected in the consolidated balance sheets approximate their fair values due to their short-term maturities.
−Removed: 2.3.5 Corlieve transaction
−Removed: On June 21, 2021, we entered into a share and purchase agreement (“SPA”) to acquire all of outstanding ordinary shares of Corlieve, a privately held French gene therapy company (“Corlieve Transaction”).
−Removed: On July 30, 2021 (“Acquisition Date”), the Company acquired Corlieve.
−Removed: The Company evaluated the Corlieve transaction as to whether or not the transaction should be accounted for as a business combination or asset acquisition.
−Removed: Refer to Note 3 “ Corlieve transaction ” for further detail.
+Added: 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.
+Added: 2.3.5 uniQure France SAS transaction
+Added: 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”).
+Added: On July 30, 2021 (“Acquisition Date”), the Company acquired uniQure France SAS.
+Added: 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.
+Added: Refer to Note 3 “ uniQure France SAS transaction ” for further detail.
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 we become aware of any events occurring or changes in circumstances that would more likely than not reduce the fair value of the reporting unit below its carrying amount.
+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.
As of December 31, 2023, 2022 and 2021, the Company has not recognized any impairment charges related to goodwill.
−Removed: Refer to Note 3 “ Corlieve transaction ” for further detail.
+Added: Refer to Note 3 “ uniQure France SAS transaction ” for further detail.
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 Corlieve in 2019 constitute an In-process research and development intangible asset (“IPR&D Intangible Asset”).
+Added: 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”).
The IPR&D Intangible Asset is considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts and is not amortized.
If and when development is completed, which generally occurs when regulatory approval to market a product is obtained, the associated asset would be deemed finite-lived and would then be amortized based on its respective useful life at that point in time.
−Removed: As of December 31, 2022 and 2021, the Company has not recognized any impairment charges related to the IPR&D Intangible Asset.
+Added: 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.
In case of abandonment, the IPR&D Intangible Asset will be written-off.
In accordance with ASC 350, Intangibles – Goodwill and Other, the Company tests indefinite-lived intangible assets for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate the fair value of the IPR&D Intangible Asset is below its carrying amount.
−Removed: Refer to Note 3 “ Corlieve transaction ” for further detail.
+Added: Refer to Note 3 “ uniQure France SAS transaction ” for further detail.
Contingent consideration
−Removed: Each reporting period, the Company revalues the contingent consideration obligations associated with the Corlieve transaction to their fair value and records changes in the fair value within research and development expenses.
−Removed: Changes in contingent consideration result from changes in assumptions regarding the probabilities of achieving the relevant milestones, or probability of success (“POS”), the estimated timing of achieving such milestones, and the interest rate to discount the payments.
−Removed: Payments made soon after the acquisition date are recorded as cash flows from financing activities, and payments, or the portion of the payments, not made soon after the acquisition date are recorded as cash flows from operating activities.
−Removed: Refer to Note 3 “ Corlieve transaction ” for further detail.
+Added: 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.
+Added: 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: 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.
+Added: Refer to Note 3 “ uniQure France SAS transaction ” for further detail.
2.3.6 Notes to the consolidated statements of cash flows
The consolidated statements of cash flows have been prepared using the indirect method.
−Removed: The cash disclosed in the consolidated statements of cash flows is comprised of cash and cash equivalents.
+Added: The cash disclosed in the consolidated statements of cash flows is comprised of cash and cash equivalents and restricted cash.
Cash and cash equivalents include bank balances, demand deposits and other short-term highly liquid investments (with maturities of less than three months at the time of purchase) that are readily convertible into a known amount of cash and are subject to an insignificant risk of fluctuation in value.
18 unchanged sentences
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 “ Corlieve transaction ” for information on impairment testing related to goodwill and acquired research and development intangible assets.
+Added: 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.
2.3.10 Investment securities
2 unchanged sentences
Held-to-maturity securities are those securities in which the Company has the ability and intent to hold the security until maturity.
−Removed: Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts.
+Added: Held-to-maturity securities are recorded at amortized cost, adjusted for applicable accrued interest and the amortization or accretion of premiums or discounts.
Premiums and discounts are amortized or accreted over the term of the related held-to-maturity security as an adjustment to yield using the effective interest rate method.
Investments securities with original maturities of less than three months when purchased are presented within cash and cash equivalents (December 31, 2023:
−Removed: $ 21.2 million, December 31, 2021:
+Added: nil , December 31, 2022:
+Added: $ 21.2 million).
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.
6 unchanged sentences
2.3.12 Inventories
−Removed: The Company started producing commercial materials in April 2022 to supply CSL Behring with the Product in accordance with the June 2020 Development and Commercial Supply Agreement between the Company and CSL Behring.
+Added: 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.
From this date onwards, the Company presents the costs associated with the aforementioned activities as cost of contract manufacturing.
1 unchanged sentence
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 the manufacturing of the Product.
+Added: The Company capitalizes raw materials to the extent these can be used in contract manufacturing for CSL Behring.
The Company uses standard costs, approximating average costs to determine its cost basis for work in progress and finished goods.
26 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 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 income / (loss).
The Company presents lease payments within cash flows from operations within the Consolidated statements of cash flows.
18 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.
+Added: The Company maintains defined benefit plans for its Swiss employees, including retirement benefit plans required by applicable local law.
+Added: 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.
+Added: 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.
+Added: 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: Service cost is reported in research and development and general and administrative expenses.
+Added: All other components of net period costs are reported in interest expense in the consolidated statement of operations and comprehensive loss.
+Added: Plan assets are recorded at their fair value.
+Added: Gains or losses arising from plan curtailments or settlements are accounted for at the time they occur.
+Added: Actuarial gains and losses arising from differences between the actual and the expected return on plan assets are recognized in accumulated other comprehensive income (loss).
2.3.20 Share-based compensation
9 unchanged sentences
2.3.21 Revenue recognition
−Removed: The Company primarily generates revenue from its commercialization and license agreement with CSL Behring and its collaboration, research, and license agreements with BMS for the development and commercialization of product candidates.
+Added: The Company primarily generates revenue from its commercialization and license agreement with CSL Behring.
+Added: The Company generated revenue from services provided to Bristol-Myers Squibb (“BMS”) until February 21, 2023 (“Termination Date”).
CSL Behring collaboration
On June 24, 2020 (“Signing Date”), the Company entered into a commercialization and license agreement pursuant to which CSL Behring received exclusive global rights to etranacogene dezaparvovec (“Product”).
+Added: On May 6, 2021, the CSL Behring Agreement became fully effective (“Closing”).
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, our investigational gene therapy for patients with hemophilia B (the “Product”) (“License Sale”);
+Added: (i) Sale of the exclusive global rights to etranacogene dezaparvovec, a gene therapy for patients with hemophilia B (the “Product”) (“License Sale”);
(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 are considered distinct from one another, as CSL Behring can benefit from the identified service either on its own or together with other resources that are readily available to CSL Behring, and as the performance obligations are separately identifiable from other performance obligations in the CSL Behring Agreement.
+Added: 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.
+Added: 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”).
+Added: 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.
Refer to Note 5 “ Collaboration arrangements and concentration of credit risk ” for further detail.
Bristol-Myers Squib collaboration
−Removed: The Company initially entered into collaboration, research, and license agreements with Bristol-Myers Squibb (“BMS”) in 2015 (“BMS CLA”) and amended them in 2020 (“amended BMS CLA”).
−Removed: The agreement terminated on February 21, 2023 (“Termination Date”).
−Removed: The Company evaluated the initial BMS CLA and determined that its performance obligations were as follows as of the amended BMS CLA:
−Removed: ● Providing pre-clinical research activities (“Collaboration Revenue”);
−Removed: ● Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”);
−Removed: ● Providing access to its technology and know-how in the field of gene therapy as well as actively contributing to the target selection, the collaboration as a whole, the development during the target selection, the pre-clinical and the clinical phase through participating in joint steering committee and other governing bodies (“License Revenue”).
−Removed: As further discussed in Note 4, “ Collaboration arrangements and concentration of credit risk ”, as a result of the December 2020 amended BMS CLA, the Company’s performance obligation related to License Revenues was materially completed as of the date of the amendment effective date of December 1, 2020.
−Removed: License Revenue
−Removed: Until the December 2020 amendment of the BMS CLA the Company recognized License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services.
−Removed: Following the December 2020 amendment of the BMS CLA the Company’s performance was materially completed and it had satisfied its performance obligation (see Note 4, “Collaboration arrangements and concentration of credit risk” , for a detailed discussion).
−Removed: Collaboration and Manufacturing Revenue
−Removed: The Company recognized Collaboration Revenue associated with optional work orders it received from BMS to provide analytical development and process development activities that were reimbursable by BMS in accordance with the BMS CLA as well as the amended BMS CLA.
+Added: The Company initially entered into collaboration, research, and license agreements with BMS in 2015 (“BMS CLA”) and amended them in 2020 (“amended BMS CLA”).
+Added: The agreement terminated on February 21, 2023.
+Added: The Company provided pre-clinical research activities ("Collaboration Revenue") under the amended BMS CLA.
2.3.22 Other income, other expense
20 unchanged sentences
As of December 31, 2023, and 2022, the Company did not have any significant unrecognized tax benefits.
+Added: 2.3.25 Royalty Financing Agreement
+Added: In May 2023, uniQure biopharma B.V.
+Added: (“uniQure biopharma”), a wholly-owned subsidiary of the Company entered into an agreement (the “Royalty Financing Agreement”) with the HemB SPV, L.P.
+Added: (the “Purchaser”) to sell certain current and future royalties due to uniQure biopharma from CSL Behring under the CSL Behring Agreement by and between uniQure biopharma and CSL Behring from the net sales of HEMGENIX®.
+Added: Refer to Note 14 “Royalty Financing Agreement” for further details of the Royalty Financing Agreement.
+Added: The Company determined that the Royalty Financing Agreement should be accounted for as debt in accordance with topic ASC 470, Debt.
+Added: The Company initially recognized the debt at fair value.
+Added: The Company subsequently records the debt at amortized cost and determines the effective interest rate based on its projection of contractual cash flows.
+Added: Interest expense (presented as “Interest Expense” in the consolidated statements of operations and comprehensive (loss) / income) is recorded over the projected repayment period using the effective interest method.
+Added: The Company periodically assesses and adjusts the effective interest rate to reflect changes in projected cash flows.
+Added: The Company prospectively applies the adjusted effective interest rate following the date of change.
+Added: In accordance with topic ASC 835, Interest, debt issuance costs incurred in relation to the Royalty Financing Agreement are presented as a reduction of carrying amount of the debt.
+Added: Debt issuance cost is amortized together with the interest expense recorded.
+Added: 2.3.26 Restructuring expenses
+Added: Restructuring charges principally consist of one-time termination benefits.
+Added: The Company records one-time termination benefits in accordance with ASC 420, Exit or Disposal Cost Obligations.
+Added: 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.
+Added: Other costs relate to the impairment of the Lexington facility that was closed as a result of a reorganization plan (the “Reorganization”).
+Added: 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.
2.3.27 Recently Adopted Accounting Pronouncements
−Removed: Government Assistance
−Removed: In November 2018, the FASB issued ASU 2021-10, Government Assistance (Topic 832) which discussed the requirements for disclosures, to be applied prospectively or retrospectively, related to transactions with a government.
−Removed: ASU 2021-10 is effective for fiscal years beginning after December 15, 2021.
−Removed: The new disclosure requirements required disclosures around 1) information about the nature of the transactions and the related accounting policy used to account for the transactions, 2) the line items on the balance sheet and income statement that are affected by the transactions, and the amounts applicable to each financial statement line item, and 3) significant terms and conditions of the transactions, including commitments and contingencies.
−Removed: The Company currently includes information on government grants and the adoption of ASU 2021-10 on January 1, 2022 has not had a material impact on the Company’s consolidated financial statements.
Recent Accounting Pronouncements Not Yet Effective
−Removed: Corlieve transaction
−Removed: At the Acquisition Date, the Company acquired Corlieve.
−Removed: Following Corlieve’s formation in November 2019, Corlieve obtained exclusive licenses to certain patents from two French research institutions that continue to collaborate with the Company.
−Removed: Corlieve also obtained an exclusive license from Regenxbio Inc.
−Removed: (“Regenxbio”) to use AAV9 to deliver any sequence that affects the expression of the Glutamate inotropic receptor kainate type subunit 2 (“GRIK2”) gene sequence in humans.
−Removed: Corlieve and Regenxbio simultaneously entered into a collaboration plan related to agreed joint preclinical research and development activities.
−Removed: At the Acquisition Date, Corlieve and its Swiss subsidiary, Corlieve Therapeutics AG, employed seven employees.
−Removed: Corlieve’s result for the full year 2021 was a $ 7.3 million loss of which $ 4.1 million was included in the Company’s consolidated results.
−Removed: The Company evaluated the Corlieve transaction as to whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets.
+Added: uniQure France SAS transaction
+Added: At the Acquisition Date, the Company acquired uniQure France SAS (formerly Corlieve Therapeutics SAS).
+Added: 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.
+Added: uniQure France SAS also obtained an exclusive license from Regenxbio Inc.
+Added: (“Regenxbio”).
+Added: uniQure France SAS and Regenxbio simultaneously entered into a collaboration plan related to agreed joint preclinical research and development activities.
+Added: At the Acquisition Date, uniQure France SAS and its Swiss subsidiary, Corlieve Therapeutics AG, employed seven employees.
+Added: 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.
Based on the fair values of the gross assets acquired, the Company determined the screen test was not met.
1 unchanged sentence
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 Corlieve, including identifiable intangible assets, were recorded at their fair values as of the Acquisition Date, when the Company obtained control.
+Added: 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.
The excess of the fair value of the consideration transferred over the fair value of the net assets acquired was recorded as goodwill.
Consideration
−Removed: On the Acquisition Date, the Company acquired 97.7 % of the outstanding ordinary shares of Corlieve in return for EUR 44.9 million ($ 53.3 million as of the Acquisition Date).
−Removed: The Company financed the Corlieve Transaction from its cash on hand.
+Added: 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).
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, Corlieve’s former shareholders are eligible to receive up to EUR 40.0 million ($ 42.8 million as of December 31, 2022) upon achievement of certain development milestones through Phase I/II and EUR 160.0 million ($ 171.3 million as of December 31, 2022) upon achievement of certain milestones associated with Phase III development and obtaining approval to commercialize Corlieve’s target candidate for the treatment of temporal lobe epilepsy (“AMT-260” or “TLE”) in the United States of America and the European Union.
+Added: 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.
The Company may elect to pay up to 25 % of such milestone payments through the issuance of the Company’s ordinary shares.
1 unchanged sentence
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 Corlieve in 2019 constitute an IPR&D Intangible Asset.
+Added: 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.
The Company determined the fair value of the IPR&D Intangible Asset using a present value model based on expected cash flows.
3 unchanged sentences
Deferred tax liability, net
−Removed: Corlieve’s deferred tax assets at the time of acquisition amounted to EUR 1.5 million ($ 1.7 million).
+Added: uniQure France SAS’s deferred tax assets at the time of acquisition amounted to EUR 1.5 million ($ 1.7 million).
Recognition of the IPR&D Intangible Asset gave rise to a deferred tax liability of EUR 13.4 million ($ 15.9 million) at the enacted French corporate income tax rate of 25.0 %.
The Company consequently recorded a net deferred tax liability of EUR 11.9 million ($ 14.2 million as of the Acquisition Date).
−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.
+Added: 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).
Goodwill represents the excess of total consideration over the estimated fair value of net assets acquired.
3 unchanged sentences
The Company does not expect any portion of this goodwill to be deductible for income tax purposes.
−Removed: As of the Acquisition Date, Corlieve held a loan with outstanding amount equal to EUR 1.0 million ($ 1.2 million), which loan was repaid in its entirety in September 2021.
−Removed: As of the Acquisition Date, Corlieve also held a loan with outstanding amount equal to EUR 0.4 million ($ 0.4 million), which was repaid in its entirety in December 2021.
+Added: 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.
+Added: 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.
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.
+Added: Reorganization
+Added: On October 5, 2023, the Company announced the Reorganization.
+Added: As a result, the Company recorded severance and other personnel related expenses for the impacted employees.
+Added: In 2023, as a part of the Reorganization, the Company decided to sublease one of its laboratories in Lexington.
+Added: The carrying amount of the right-of-use asset was determined not to be recoverable.
+Added: As a result, the Company recorded impairment charges for the related operating lease right-of-use assets and leasehold improvements.
+Added: A summary of the restructuring charges for the year ended December 31, 2023 by major activity type is as follows:
+Added: Severance and Other Personnel Costs
+Added: Impairment Charges
+Added: (in thousands)
+Added: Research and development
+Added: General and administrative
+Added: 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:
+Added: Amount of liability
+Added: (in thousands)
+Added: Balance as of January 1, 2023
+Added: Severance and other personnel costs
+Added: Cash payments during the period
+Added: Balance as of December 31, 2023
Collaboration arrangements and concentration of credit risk
CSL Behring collaboration
−Removed: On the Signing Date, uniQure biopharma B.V., a wholly-owned subsidiary of uniQure N.V., entered into the CSL Behring Agreement with CSL Behring, pursuant to which CSL Behring received exclusive global rights to the Product.
−Removed: On May 6, 2021, a day after the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the CSL Behring Agreement became fully effective (“Closing”).
−Removed: The Company concluded that CSL Behring is a customer in accordance with Topic 606.
−Removed: The Company identified two material performance obligations related to the CSL Behring Agreement:
−Removed: (i) License Sale;
−Removed: (ii) Manufacturing Development.
−Removed: These performance obligations are considered distinct from one another, as CSL Behring can benefit from the identified service either on its own or together with other resources that are readily available to CSL Behring, and as the performance obligations are separately identifiable from other performance obligations in the CSL Behring Agreement.
−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.
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.
8 unchanged sentences
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 considers the occurrence of this event to be probable following the November 2022 BLA approval of HEMGENIX™.
−Removed: Despite the approval of the MAA for HEMGENIX™ by the Europeans Medicines Agency (“EMA”) in February 2023, the Company did not record the $ 75.0 million variable milestone payment related to a first sale of HEMGENIX™ in the one of five major European countries, namely France, Germany, Italy, Spain, and the United Kingdom, as license revenue in the year ended December 31, 2022.
−Removed: The Company considers that the milestone is only owed if achieved prior to July 2, 2023, which is contingent on factors outside the Company’s control and thus the Company determined that occurrence was not probable as of December 31, 2022.
−Removed: The Company is also eligible to receive up to $ 1.3 billion in additional payments based on the achievement of commercial milestones.
−Removed: The CSL Behring Agreement also provides that the Company will be eligible to receive tiered double-digit royalties in a range of up to a low-twenties percent of net sales of the Product based on sales thresholds.
−Removed: The Company will include payments related to sales milestones in the transaction price when their achievement becomes probable, and it will include royalties on the sale of Product once these have been earned.
−Removed: The Company recognized $ 100.0 million and $ 517.4 million of revenues related to the License Sale in the years ended December 31, 2022 and December 31, 2021, respectively ( nil in 2020).
−Removed: The Company records expenses related to its existing license and other agreements as well as its financial advisor for a high single digit percentage of any such revenue recognized associated to meeting a milestone.
+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: 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.
+Added: Royalties on the sale of HEMGENIX® are recorded once earned and are presented as license revenue.
+Added: 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.
+Added: 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.
Manufacturing Development
−Removed: The Company determined that the $ 50.0 million variable milestone payment related to Manufacturing Development should be allocated to the Manufacturing Development performance obligation.
+Added: The Company determined that a $ 50.0 million variable milestone payment related to Manufacturing Development should be allocated to the Manufacturing Development performance obligation.
The Company concluded that this milestone payment represents the stand-alone selling price (“SSP”) of the services based on the estimated cost of providing the services including a reasonable margin.
1 unchanged sentence
CSL Behring did not request such services during the year ended December 31, 2023.
−Removed: The variable consideration will be reduced if the Company does not complete the development by pre-agreed dates following BLA, respectively MAA approval.
+Added: 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.
+Added: 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.
The Company utilized the most likely amount method to estimate the variable consideration to be included in the transaction price.
1 unchanged sentence
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 the Product to CSL Behring at an agreed-upon price commensurate with the SSP.
+Added: 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.
The Company will be responsible for supplying development and commercial Product until such time that these capabilities may be transferred to CSL Behring or a designated contract manufacturing organization.
On September 6, 2022, CSL Behring notified the Company of its intent to transfer manufacturing technology related to the Product in the coming years to a third-party contract manufacturer designated by CSL Behring.
−Removed: CSL Behring also requested that the Company continue to serve as a manufacturer of the Product after the Company completes the technology transfer to a third party.
−Removed: The Company and CSL Behring are in the process of negotiating the terms of the transfer of manufacturing responsibility pursuant to the CSL Behring Agreement.
−Removed: The Company generated $ 1.7 million contract manufacturing revenue from sales to CSL Behring.
−Removed: The Company recognizes contract manufacturing revenue when CSL Behring obtains control of the Product.
−Removed: The Company incurred $ 2.1 million of cost in relation to its contract manufacturing activities during the year ended December 31, 2022.
+Added: 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.
+Added: The Company recognizes contract manufacturing revenue when CSL Behring obtains control of HEMGENIX ®.
+Added: 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.
Collaboration services
Following Closing, the Company was facilitating the completion of the HOPE-B clinical trial on behalf of CSL Behring until CSL Behring took over the execution of the clinical trials in December 2022.
−Removed: Activities related to on-demand development services as well as activities related to the completing the HOPE-B clinical trial are reimbursed by CSL Behring at an agreed full-time-employee rate (“FTE-rate”) and CSL Behring also reimburses agreed third-party expenses incurred in relation to performing these activities.
−Removed: The Company concluded that these rights at Closing do not represent material rights.
−Removed: The Company recognized $ 3.0 million of collaboration revenue in the year ended December 31, 2022, compared to $ 2.4 million and nil in the same periods in 2021 and 2020.
+Added: 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.
+Added: The Company concluded that these rights at Closing did not represent material rights.
+Added: 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.
Accounts r eceivable and c ontract asset
−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 expected to be received from CSL Behring following the first sale of HEMGENIX™ in the U.S in 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™.
+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: 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.
+Added: 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.
Bristol-Myers Squibb collaboration
−Removed: 2015 agreement
−Removed: In May 2015, the Company entered into the BMS CLA and various related agreements with BMS, which the Company collectively refers to as the BMS CLA, which provided BMS with exclusive access to the Company’s gene therapy technology platform for the research, development and commercialization of therapeutics aimed at multiple Collaboration Targets.
−Removed: The initial four-year research term under the collaboration terminated on May 21, 2019.
−Removed: 2020 amendment
−Removed: On December 1, 2020, the Company and BMS entered into the amended BMS CLA.
−Removed: Under the amended BMS CLA, BMS was limited to four Collaboration Targets.
−Removed: For a period of one-year from the effective date of the amended BMS CLA, BMS was able to replace up to two of the four active Collaboration Targets with two new targets in the field of cardiovascular disease.
−Removed: The Company continued to be eligible to receive research, development, and regulatory milestone payments of up to $ 217.0 million for each Collaboration Target, if defined milestones had been achieved.
−Removed: Since the December 2020 amendment, BMS no longer was entitled to designate a fifth to tenth Collaboration Targets and as such the Company’s remaining obligations under the amended BMS CLA were substantially reduced.
−Removed: The Company also no longer was entitled to receive up to an aggregate $ 16.5 million in target designation payments for the research, development and regulatory milestone payments associated with the fifth to tenth Collaboration Targets.
−Removed: For as long as any of the four Collaboration Targets were being advanced, BMS might have placed a purchase order to be supplied with research, clinical and commercial supplies.
−Removed: The amended BMS CLA did not extend the initial four-year research term that expired in May 2019.
−Removed: BMS could place purchase orders to be provided with limited services primarily related to analytical and development efforts in respect of the four Collaboration Targets.
−Removed: BMS could have requested such services for a period not to exceed the earlier of (i) the completion of all activities under a Research Plan and (ii) November 30, 2023.
−Removed: BMS continued to reimburse the Company for these services.
−Removed: 2022 Termination
On November 21, 2022, the Company received written notice that BMS is terminating the BMS CLA as amended effective February 21, 2023.
−Removed: Services to BMS were rendered by the Dutch operating entity.
−Removed: Total collaboration and license revenue generated with BMS are as follows (presented as revenue from a related party up until the effective date of the amended BMS CLA and presented as revenue after the effective date):
+Added: 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.
+Added: Collaboration revenue related to these contracted services was recognized when performance obligations were satisfied.
+Added: Total collaboration revenue generated with BMS are as follows:
Years ended December 31,
1 unchanged sentence
Bristol Myers Squibb
−Removed: Amounts owed by BMS in relation to the Collaboration and License Revenue are as follows (presented as “Accounts receivables” as of December 31, 2022 and 2021:
+Added: Amounts owed by BMS in relation to the collaboration revenue are as follows (presented as “Accounts receivable”) as of December 31, 2023:
(in thousands)
Bristol Myers Squibb
−Removed: License Revenue
−Removed: The Company recognized no License Revenue for the year ended December 31, 2022 (December 31, 2021:
−Removed: nil million, December 31, 2020:
−Removed: $ 33.0 million).
−Removed: In 2015 the Company received $ 75.1 million of payments that it allocated to License Revenue.
−Removed: The Company recognized License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services.
−Removed: The Company did not identify any new distinct performance obligations and determined the amended BMS CLA did not represent a separate contract in accordance with ASC 606.
−Removed: The Company evaluated the effect the modification had on its measure of progress towards the completion of its performance obligation related to License Revenue and determined that its remaining performance obligation under the amended BMS CLA was immaterial and recognized the remaining balance of unrecognized License Revenue as of November 30, 2020 of $ 27.8 million in profit and loss during the year ended December 31, 2020 as License Revenue from a related party.
−Removed: The Company included variable consideration related to any research, development, and regulatory milestone payments, in the transaction price once it considered it probable that including these payments in the transaction price would not result in the reversal of cumulative revenue recognized.
−Removed: Due to the significant uncertainty surrounding the development of gene-therapy product candidates and the dependence on BMS’s performance and decisions, the Company with the exception of a $ 4.4 million research milestone payment received and recorded as License Revenue in December 2020 did not consider this probable as of December 31, 2021.
−Removed: No variable consideration became due prior to the termination of the amended BMS CLA on February 21, 2023.
−Removed: Under the amended BMS CLA, the Company would have recognized License Revenue related to product sales by BMS from any of the Collaboration Targets when the sales would have occurred.
−Removed: The Company was eligible to receive net sales-based milestone payments and tiered mid-single to low double-digit royalties on product sales.
−Removed: Collaboration Revenue
−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 BMS CLA and 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: The Company generated $ 1.8 million collaboration revenue for the year ended December 31, 2022 (December 31, 2021:
−Removed: $ 4.2 million;
−Removed: December 31, 2020:
−Removed: $ 0.2 million).
−Removed: Investment securities
−Removed: The following table summarizes the Company’s investments into sovereign debt as of December 31, 2022:
+Added: Investments securities
+Added: The following table summarizes the Company’s investments into sovereign debt as of December 31, 2023 and 2022:
At December 31, 2023
−Removed: Amortized cost, as adjusted
+Added: Amortized cost
Gross unrealized holding gains
3 unchanged sentences
Current investments:
−Removed: Obligations of governmental agencies (held-to-maturity)
+Added: Government debt securities (held-to-maturity)
+Added: At December 31, 2022
+Added: Amortized cost
+Added: Gross unrealized holding gains
+Added: Gross unrealized holding losses
+Added: Estimated fair value
+Added: (in thousands)
+Added: Current investments:
+Added: Government debt securities (held-to-maturity)
Non-current investments:
−Removed: Obligations of governmental agencies (held-to-maturity)
−Removed: No investments classified as held-to-maturity were purchased in the prior years.
+Added: Government debt securities (held-to-maturity)
+Added: The Company invests in short-term U.S.
+Added: and European government bonds with the highest investment credit rating.
+Added: and European government bonds are U.S.
+Added: dollar and euro denominated, respectively.
Inputs to the fair value of the investments are considered Level 2 inputs.
−Removed: The following table summarizes the inventory balances as of December 31, 2022:
+Added: The following table summarizes the inventory balances, net of reserves, as of December 31, 2023:
(in thousands)
2 unchanged sentences
Finished goods
+Added: The Company recorded write downs of $ 1.6 million and nil for the years ended December 31, 2023 and December 31, 2022.
+Added: The costs are recognized as Cost of Contract Manufacturing Revenues.
Fair value measurement and Other non-operating (losses) / gains
The Company measures certain financial assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting.
−Removed: The carrying amount of cash and cash equivalents, accounts receivable from licensing and collaboration partners, prepaid expenses, other assets, accounts payable, accrued expenses and other current liabilities reflected in the consolidated balance sheets approximate their fair values due to their short-term maturities.
+Added: 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.
The Company’s material financial assets include cash and cash equivalents, restricted cash and investment securities.
6 unchanged sentences
Balance at December 31, 2020
−Removed: Net gains recognized in profit or loss
−Removed: Derecognition of BMS warrants
−Removed: Recognition of derivative financial liability of CoC-payment
+Added: Amount recorded for contingent consideration on Acquisition Date of uniQure France SAS
+Added: Net losses recognized in profit or loss
Currency translation effects
Balance at December 31, 2021
−Removed: Amount recorded for contingent consideration on Acquisition Date of Corlieve
−Removed: Net losses recognized in profit or loss
+Added: Net losses / (gains) recognized in profit or loss
Currency translation effects
1 unchanged sentence
Net losses recognized in profit or loss
+Added: Contingent consideration milestone payment
Currency translation effects
1 unchanged sentence
Contingent consideration
−Removed: The Company is required to pay up to EUR 178.8 million ($ 191.4 million at the December 31, 2022 foreign exchange rate) to the former shareholders of Corlieve upon the achievement of contractually defined milestones in connection with the Company’s acquisition of Corlieve (refer to Note 3 “Corlieve transaction” ).
+Added: 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” ).
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.
4 unchanged sentences
bonds with a CCC credit rating.
−Removed: The fair value of the contingent consideration as of December 31, 2022 was $ 35.3 million (2021:
−Removed: $ 29.5 million) using discount rates ranging from 14.0 % to 14.4 % (December 31, 2021:
−Removed: 10.9 % to 11.9 %) as well as a 66.0 % (December 31, 2021:
−Removed: 55.0 %) likelihood of AMT-260 advancing into clinical development by no later than late 2023.
−Removed: If as of December 31, 2022 the Company had assumed a 100 % likelihood of AMT-260 advancing into clinical development, then the fair value of the contingent consideration would have increased to $ 48.8 million.
−Removed: If as of December 31, 2022 the Company assumed that it would discontinue development of the AMT-260 program, then the contingent consideration would be released to income.
−Removed: Changes in fair value of the contingent liability are recognized within research and development expenses in the consolidated statements of operations.
+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: The fair value of the contingent consideration as of December 31, 2023 was $ 43.0 million (December 31, 2022:
+Added: $ 35.3 million) using discount rates of approximately 15.3 % to 15.6 % (December 31, 2022:
+Added: 14.0 % to 14.4 %).
+Added: 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: This also resulted in an increase of the probability that AMT-260 may advance to late-stage development and commercialization.
+Added: 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: If as of December 31, 2023 the Company had assumed that it would discontinue development of the AMT-260 program, then the contingent consideration would have been released to income.
As of December 31, 2023, the Company classified $ 28.2 million of the total contingent consideration of $ 43.0 million as current liabilities.
9 unchanged sentences
Derivative losses
−Removed: Other non-operating (losses) / gains, net
+Added: Other non-operating gains / (losses), net
Derivative financial instruments BMS
−Removed: Pursuant to the BMS CLA, the Company in 2015 granted BMS two warrants that were subsequently terminated in connection with the amendment to the BMS CLA on December 1, 2020.
−Removed: The Company granted to BMS:
−Removed: ● A warrant that allowed BMS to purchase a specific number of the Company’s ordinary shares such that its ownership would have equaled 14.9 % immediately after such purchase (“1 st warrant”).
−Removed: The 1 st warrant could have been exercised on the later of (i) the date on which the Company received from BMS the Target Designation Fees (as defined in the BMS CLA) associated with the first six new targets (a total of seven Collaboration Targets);
−Removed: and (ii) the date on which BMS designated the sixth new target (the seventh Collaboration Target);
−Removed: ● A warrant that allowed BMS to purchase a specific number of the Company’s ordinary shares such that its ownership would have equaled 19.9 % immediately after such purchase (“2 nd warrant” and together with 1 st warrant, the “warrants”).
−Removed: The warrant could have been exercised on the later of (i) the date on which the Company received from BMS the Target Designation Fees associated with the first nine new targets (a total of ten Collaboration Targets);
−Removed: and (ii) the date on which BMS designated the ninth new target (the tenth Collaboration Target).
−Removed: On December 1, 2020, the Company derecognized the warrants when these were terminated in accordance with the amended BMS CLA.
−Removed: During the year ended December 31, 2020, the Company recognized a $ 3.1 million gain in non-operating (losses) / gains related to the fair value changes of the BMS warrants, which includes $ 0.8 million from the derecognition of the BMS warrants on December 1, 2020.
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”).
−Removed: The Company determined that the CoC-payment should be recorded as a derivative financial liability as of the December 1, 2020 initial recognition and that subsequent changes in the fair market value of this derivative financial liability should be recorded in profit and loss.
−Removed: The fair market value of the derivative financial liability is materially impacted by the probability that market participants assign to the likelihood of the occurrence of a change of control transaction that would give rise to a CoC-payment.
−Removed: This probability represents an unobservable input.
−Removed: The Company determined the fair market value of the derivative financial liability by using a present value model based on expected cash flow.
−Removed: The expected cash flows are materially impacted by the probability that market participants assign to the likelihood of the occurrence of a change of control transaction within the biotechnology industry.
−Removed: The Company estimated this unobservable input using the best information available as of December 2021.
−Removed: The Company obtained reasonably available market information that it believed market participants would use in determining the likelihood of the occurrence of a change-of control transaction within the biotechnology industry.
−Removed: Selecting and evaluating market information involves considerable judgment and uncertainty.
−Removed: Based on all such information and its judgment, the Company estimated that the fair market value of the derivative financial liability (presented within “Other non-current liabilities”) as of December 31, 2021 was $ 2.8 million.
−Removed: The Company recorded a $ 0.2 million loss in the year ended December 31, 2021 related to an increase in the fair market value of the derivative financial liability and a $ 2.6 million loss in the year ended December 31, 2020 related to the initial recognition of this derivative financial liability
+Added: The amended BMS CLA was terminated on February 21, 2023.
+Added: 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.
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: The Company considered the probability of a change of control transaction occurring before the Termination Date to be remote.
This resulted in the derecognition of the derivative financial liability for the year ended December 31, 2022.
−Removed: Accordingly, the Company recorded a $ 2.8 million gain within “Other non-operating (losses) / gains” in the year ended December 31, 2022
−Removed: As of December 31, 2022, the Company recorded $ 0.3 million liability related to consideration for post-acquisition services, presented within Other non-current liabilities in connection with the Company’s acquisition of Corlieve (December 31, 2021:
+Added: 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.
+Added: 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:
$ 0.3 million).
1 unchanged sentence
Refer to Note 6 “ Investment securities ” for the fair value of the investment securities as of December 31, 2023.
+Added: Pension plan assets
+Added: Refer to Note 15 “ Retirement benefits ” for the fair value of the plan assets as of December 31, 2023.
Property, plant, and equipment, net
29 unchanged sentences
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, is set for seven years and is non-cancellable.
−Removed: The lease is renewable for one five-year term.
+Added: The lease commenced in May 2022.
+Added: 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.
+Added: This facility is intended to be subleased in 2024.
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.
7 unchanged sentences
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 $ 4.8 million (EUR 4.5 million) as of December 31, 2022.
+Added: 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.
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.
−Removed: The lease expires in October 2028 and includes an option to break the lease on October 31, 2023.
+Added: The lease expires in October 2028.
Operating lease liabilities
42 unchanged sentences
All acquired licenses are owned by uniQure biopharma B.V, a subsidiary of the Company.
−Removed: The remaining weighted average life is 11.5 years as of December 31, 2022.
−Removed: (December 31 , 2021 10.8 years.)
+Added: The remaining weighted average life is 10.5 years as of December 31, 2023 (December 31, 2022 11.5 years).
As of December 31, 2023, the estimated future amortization expense for each of the five succeeding years and the period thereafter is as follows:
4 unchanged sentences
$ 1.2 million).
−Removed: In 2020, the Company disposed of a number of licenses determined to have no alternative future use.
−Removed: The impairment expense related to licenses for the year ended December 31, 2022 was $ 0.0 million (December 31, 2021:
−Removed: $ 0.0 million;
−Removed: December 31, 2020 $ 0.3 million).
Acquired in-process research and development
−Removed: As part of its acquisition of Corlieve as of July 30, 2021, the Company identified certain intangible assets related to an IPR&D Intangible Asset.
−Removed: Refer to Note 3 “Corlieve transaction” .
−Removed: As part of its acquisition of Corlieve as of July 30, 2021, the Company recorded goodwill.
−Removed: Refer to Note 3 “Corlieve transaction” .
+Added: 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.
+Added: Refer to Note 3 “uniQure France SAS transaction” .
+Added: As part of its acquisition of uniQure France SAS as of July 30, 2021, the Company recorded goodwill.
+Added: Refer to Note 3 “uniQure France SAS transaction” .
Accrued expenses and other current liabilities
1 unchanged sentence
(in thousands)
−Removed: Accruals for goods received from and services provided by vendors-not yet billed
Personnel related accruals and liabilities
+Added: Accruals for goods received from and services provided by vendors-not yet billed
+Added: Liability owed to the Purchaser pursuant to the Royalty Financing Agreement
Accrued contract fulfillment costs and costs to obtain a contract
1 unchanged sentence
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, and again on May 6, 2016 (“2016 Amended Facility”).
−Removed: On December 6, 2018, the Company signed an amendment that both refinanced the then-existing $ 20.0 million 2016 Amended Facility and allowed the Company to draw down an additional $ 15.0 million (“2018 Amended Facility”).
−Removed: The 2018 Amended Facility extended the loan’s maturity date from May 1, 2020 until June 1, 2023.
−Removed: The interest rate was adjustable and was the greater of (i) 8.85 % and (ii) 8.85 % plus the prime rate less 5.50 % per annum.
−Removed: In May 2020 the Company paid a back-end fee of $ 1.0 million in relation to the 2016 Amended Facility.
+Added: (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”).
On January 29, 2021, the Company and Hercules amended the 2018 Amended Facility (“2021 Amended Facility”).
2 unchanged sentences
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 had been extended by the Company by up to two twelve-month periods.
−Removed: Advances under the 2021 Amended Facility could have been prepaid without charge after July 29, 2021.
−Removed: The back-end fee in respect of advances under the 2021 Amended Facility ranged from 1.65 % to 6.85 %, depending on the repayment date.
+Added: 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.
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.
3 unchanged sentences
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 is approved by the U.S.
−Removed: Food and Drug Administration (“FDA”) or (b) AMT-130 is advanced into a pivotal trial.
+Added: 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.
+Added: Food and Drug Administration (“FDA”) or (b) AMT-130 had advanced into a pivotal trial.
On November 22, 2022, the FDA approved the BLA for AMT-061 resulting in the extension of the interest-only period to December 1, 2025.
+Added: On May 12, 2023 the Company and Hercules amended the 2021 Restated Facility (the “2023 Amended Facility”).
+Added: The total principal outstanding under the 2023 Amended Facility remained $ 100.0 million.
+Added: The 2023 Amended Facility extended the maturity date and interest only period from December 1, 2025 to January 5, 2027 (the “Maturity Date”).
The Company is required to repay the entire principal balance on the Maturity Date.
The interest rate is adjustable and is the greater of (i) 7.95 % and (ii) 7.95 % plus the prime rate less 3.25 % per annum.
−Removed: Under the 2021 Restated Facility, the Company owes a back-end fee of $ 2.5 million on June 1, 2023 and a back-end fee of $ 4.85 million on the maturity date.
−Removed: The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2021 Restated Facility was $ 103.8 million as of December 31, 2022, compared to an amortized cost of $ 101.6 million for the 2021 Restated Facility as of December 31, 2021, and is recorded net of discount and debt issuance costs.
−Removed: The foreign currency loss on the loan was $ 5.8 million in 2022 (2021:
+Added: The Company paid a $ 2.5 million back-end fee in June 2023.
+Added: 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: The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2023 Amended Facility was $ 102.9 million as of December 31, 2023, compared to an amortized cost of $ 103.8 million as of December 31, 2022, and is recorded net of discount and debt issuance costs.
+Added: The foreign currency gain on the loan was $ 3.0 million in 2023 (2022:
loss of $ 5.8 million;
−Removed: gain of $ 3.1 million).
+Added: loss of $ 5.3 million).
The fair value of the loan approximates its carrying amount.
2 unchanged sentences
(in millions)
−Removed: As a covenant in the 2021 Restated Facility the Company has periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the United States, equivalent to the lesser of (i) 65 % of the outstanding balance of principal due or (ii) 100 % of worldwide cash and cash equivalents.
+Added: Under the 2023 Amended Facility the Company must remain current in its periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the United States, equivalent to the lesser of (i) 65 % of the outstanding balance of principal due or (ii) 100 % of worldwide cash and cash equivalents.
This restriction on cash and cash equivalents only relates to the location of the cash and cash equivalents, and such cash and cash equivalents can be used at the discretion of the Company.
−Removed: Following the approval of the BLA by the FDA for AMT-061 in November 2022, the Company, beginning on April 1, 2024, is required to keep a minimum of unrestricted cash of at least 30 % of the loan amount outstanding.
−Removed: In combination with other covenants, the 2021 Restated Facility restricts the Company’s ability to, among other things, incur future indebtedness and obtain additional debt financing, to make investments in securities or in other companies, to transfer assets, to perform certain corporate changes, to make loans to employees, officers, and directors, and to make dividend payments and other distributions to its shareholders.
−Removed: The Company secured the facilities by directly or indirectly pledging its total assets of $ 705.0 million with the exception of $ 63.7 million of cash and cash equivalents and other current assets held by uniQure N.V and $ 85.2 million of other current assets and investment held by Corlieve Therapeutics SAS.
−Removed: The 2021 Restated Facility contain provisions that include the occurrence of a material adverse effect, as defined therein, which would entitle Hercules to declare all principal, interest and other amounts owed by the Company immediately due and payable.
+Added: Beginning on April 1, 2024, the Company is required to keep a minimum of unrestricted cash of at least 30 % of the loan amount outstanding.
+Added: In combination with other covenants, the 2023 Amended Facility restricts the Company’s ability to, among other things, incur future indebtedness and obtain additional debt financing, to make investments in securities or in other companies, to transfer assets, to perform certain corporate changes, to make loans to employees, officers, and directors, and to make dividend payments and other distributions to its shareholders.
+Added: The Company secured the facilities by directly or indirectly pledging its total assets of $ 831.7 million, less $ 9.3 million of cash and cash equivalents and other current assets held by the Company and $ 90.4 million of other current assets and investment held by uniQure France SAS as well as receivables sold to the Purchaser.
+Added: Under the 2023 Amended Facility, the occurrence of a material adverse effect, as defined therein, would entitle Hercules to declare all principal, interest and other amounts owed by the Company immediately due and payable.
As of December 31, 2023, the Company was in material compliance with all covenants and provisions.
1 unchanged sentence
(in thousands)
+Added: Royalty Financing Agreement
+Added: On May 12, 2023, the Company entered into the Royalty Financing Agreement with the Purchaser.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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 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.
+Added: Net proceeds from the Royalty Financing Agreement, after deducting professional and financial advisory fees related to the transaction of $ 4.9 million, were $ 370.1 million.
+Added: The Company initially recorded these net proceeds as “Liability from royalty financing agreement” at their fair market value on its balance sheet as of closing of the transaction on June 5, 2023.
+Added: Following the initial recognition, the Company records the debt at amortized cost.
+Added: The Company expects to satisfy its commitment to the Purchaser prior to the First Hard Cap Date.
+Added: The Company will record the difference of $ 323.7 million between the total expected payments of $ 693.8 million to the Purchaser and the $ 370.1 million net proceeds as interest expense using the effective interest rate method.
+Added: The Company determined the effective interest rate based on the projected cash flows up to the First 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.
+Added: 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).
+Added: The Company will prospectively update the effective interest rate at each reporting date based on updated projections.
+Added: The liability was initially recognized at fair value and inputs were considered Level 3 inputs.
+Added: 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: Amount of liability
+Added: (in thousands)
+Added: Gross proceeds from royalty financing agreement on June 5, 2023
+Added: Debt issuance costs paid
+Added: Royalty payments to Purchaser
+Added: Liability owed to the Purchaser (presented as "Accrued expense and other current liabilities")
+Added: Interest expense for the period June 5, 2023 to December 31, 2023
+Added: Liability related to the royalty financing agreement
+Added: Retirement benefits
+Added: Defined benefit pension plan
+Added: The Company operates a defined benefit pension plan for its Swiss employees (the “Swiss Plan”) in accordance with local regulations and practices.
+Added: The normal retirement age under the Swiss Plan is 65 for men and women.
+Added: All benefits are immediately vested.
+Added: Under the Swiss Plan, a percentage of pensionable salary is contributed as a retirement credit with additional contributions being made for death and disability benefits.
+Added: Under Swiss pension law, participants who are covered by the pension plan of another employer are required to transfer the termination benefit of that pension plan into the plan of the Company.
+Added: When employment at the Company ends before reaching retirement, the termination benefit is transferred out of the defined benefit pension plan.
+Added: At time of retirement the accumulated retirement credit can be converted into a life-long annuity or be paid-out as a lump-sum.
+Added: 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.
+Added: 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.
+Added: The funded status of the Swiss Plan as of December 31, 2023 is as follows:
+Added: (in thousands)
+Added: Fair value of plan assets
+Added: Present value of projected benefit obligation
+Added: Funded status:
+Added: (net liability)
+Added: Accumulated benefit obligation as of December 31, 2023
+Added: 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: The assumptions related to the Swiss Plan are as follows:
+Added: Actuarial assumptions (% p.a.)
+Added: Discount rate
+Added: Expected return on plan assets
+Added: Expected inflation rate
+Added: Interest credit rate
+Added: Long-term expected rate of salary increases
+Added: Pension increase
+Added: Future benefits expected to be paid are as follows:
+Added: Other disclosure items:
+Added: Next year's expected employer contribution
+Added: The Company's investment strategy for its pension plan is to optimize the long-term investment return on plan assets in relation to the liability structure to maintain an acceptable level of risk while minimizing the cost of providing pension benefits and maintaining adequate funding levels in accordance with the applicable rules in each jurisdiction.
+Added: The Company does not manage any assets internally.
+Added: The plan assets relate to assets being held by the Swiss pension foundations in which the Company's pension plan is set-up.
+Added: The allocation of plan assets is presented below:
+Added: The fair value of the plan assets is determined based on Level 2 inputs.
Shareholders’ equity
3 unchanged sentences
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.
−Removed: As of December 31, 2022, and 2021 and 2020 the Company’s other comprehensive result was restricted for payment of dividends for an accumulated other comprehensive loss of $ 58.3 million in 2022, an accumulated other comprehensive loss of $ 28.9 million in 2021, and an accumulated other comprehensive gain of $ 9.9 million in 2020.
+Added: As of December 31, 2023, and 2022 and 2021 the Company’s other comprehensive result was restricted for payment of dividends for an accumulated other comprehensive loss of $ 53.6 million in 2023, an accumulated other comprehensive loss of $ 58.3 million in 2022, and an accumulated other comprehensive loss of $ 28.9 million in 2021.
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.
2 unchanged sentences
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 year ended December 31, 2022).
+Added: 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).
Following the Closing of the CSL Behring transaction, the Company consumed its tax net operating loss carryforwards from the years 2011 to 2018.
1 unchanged sentence
This resulted is an increase of additional paid-in capital of $ 3.0 million in 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 within the Netherlands.
+Added: 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 was as follows:
+Added: Share-based compensation expense recognized by classification included in the consolidated statements of operations and comprehensive (loss) / income was as follows:
Year ended December 31,
21 unchanged sentences
As of December 31, 2023, no fully vested share options are outstanding (December 31, 2022:
−Removed: 14,000 ) under the 2012 Plan.
+Added: nil ) under the 2012 Plan.
At the general meeting of shareholders on January 9, 2014, the Company’s shareholders approved the adoption of the 2014 Plan.
−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 and 4,000,000 shares in 2021 for a total of 12,601,471 shares.
+Added: 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.
+Added: 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.
Share options
38 unchanged sentences
2.1 % - 4.2 %
−Removed: 0.76 % - 1.44 %
Expected dividend yield
32 unchanged sentences
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 one year or three years , or the achievement of defined milestones, subject to the grantee’s continued employment.
+Added: 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.
In addition, portions of the December 2021 granted to executives and other members of senior management are subject to achieving a minimum total shareholder return relative to the Nasdaq biotechnology index.
The Company recognizes the compensation cost related to these grants to the extent it considers achievement of the milestones to be probable.
−Removed: Achievement of one of the total five defined milestones was met and one of the five defined milestones was considered probable as of December 31, 2022.
+Added: As of December 31, 2023, two milestones had been achieved and vested in either 2022 or 2023.
+Added: Additionally, another two milestones are considered probable as of December 31, 2023.
In January 2018 and January and February 2019, the Company awarded PSUs to its executives and other members of senior management.
1 unchanged sentence
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 those were earned for the 2019 PSUs, and the date of the grant for the 2021 and 2022 PSUs:
+Added: 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:
Weighted average
9 unchanged sentences
The purchase price of the shares on each purchase date is equal to 85 % of the lower of the closing market price on the offering date or the closing market price on the purchase date of each three-month offering period.
−Removed: During the year ended December 31, 2022, 11,242 shares have been issued (December 31, 2021:
+Added: During the year ended December 31, 2023, 19,198 ordinary shares have been issued (December 31, 2022:
11,242 and December 31, 2021:
8 unchanged sentences
Legal and advisory expenses
+Added: Fair value loss - uniQure France SAS contingent consideration
Other operating expenses
−Removed: Patent and license expenses
Depreciation and amortization expenses
−Removed: Fair value loss - Corlieve contingent consideration
+Added: Patent and license expenses
+Added: Impairment related to the Reorganization
Details of employee-related expenses for the years ended December 31 are as follows:
3 unchanged sentences
Share-based compensation expenses
+Added: Contractor expenses
Social security costs
Health insurance
−Removed: Contractor expenses
+Added: Costs related to pension plans
+Added: Severance costs related to the Reorganization (refer to Note 4 " Reorganization ")
Other employee expenses
−Removed: Pension costs - defined contribution plans
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.
7 unchanged sentences
entered into in April 2021.
−Removed: In the year ended December 31, 2022, the Company recognized $ 0.3 million of other income related to the equity stake received in VectorY.
−Removed: No such income was recorded in the year ending December 31, 2020.
+Added: 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.
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.
Income tax (benefit) / expense
−Removed: 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.
−Removed: The Company released a full valuation allowance against the Company’s net deferred tax assets in the United States as of December 31, 2020.
−Removed: In connection with the Corlieve acquisition, the Company recognized a deferred tax liability related to acquired identifiable intangible assets and a deferred tax asset for net operating tax loss carryforwards for a net of EUR 11.9 million ($ 14.2 million) as of the Acquisition Date.
+Added: 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.
+Added: 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, 2023 and 2022.
3 unchanged sentences
Dutch operations
−Removed: The income tax benefit / (expense) for the years ended December 31, 2022, 2021 and 2020, consists of the following:
+Added: The income tax (expense) / benefit for the years ended December 31, 2023, 2022 and 2021, consists of the following:
Years ended December 31,
1 unchanged sentence
Current tax expense
−Removed: Total current tax (expense)
−Removed: Deferred tax benefit / (expense)
+Added: Total current income tax expense
+Added: Deferred tax (expense) / benefit
Dutch operations
−Removed: Total deferred tax benefit / (expense)
−Removed: Total income tax benefit / (expense)
+Added: Total deferred tax (expense) / benefit
+Added: Total income tax (expense) / benefit
+Added: Tax benefit recognized in other comprehensive income
+Added: 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: Year ended December 31, 2023
+Added: (in thousands)
+Added: Unrecognized gain related to defined benefit pension plan liability
+Added: No income tax benefit or expense has been recognized in Other Comprehensive Income for the years ended December 31, 2022 and 2021.
Tax rate reconciliation
−Removed: The reconciliation of the amount of income tax benefit / (expense) that would result from applying the Dutch statutory income tax rate to the Company’s reported amount of (loss) / income before income tax benefit / (expense) for the years ended December 31, 2022, 2021 and 2020, is as follows:
+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) / income before income tax (expense) / benefit for the years ended December 31, 2023, 2022 and 2021, is as follows:
Years ended December 31,
(in thousands)
−Removed: (Loss) / income before income tax benefit / (expense) for the period
+Added: (Loss) / income before income tax (expense) / benefit for the period
Expected income tax benefit / (expense) at the tax rate enacted in the Netherlands (2023:
1 unchanged sentence
25.8 %, 2021:
−Removed: Non-deductible expenses
−Removed: Other net change in valuation allowance
Difference in tax rates between the Netherlands and the U.S.
as well as other foreign countries
−Removed: Release of valuation allowance related to expected future taxable income of U.S.
−Removed: Income tax benefit / (expense)
+Added: Other net change in valuation allowance
+Added: Non-deductible expenses
+Added: Income tax (expense) / benefit
Non-deductible expenses predominantly relate to share-based compensation expenses.
2 unchanged sentences
$ 6.7 million).
−Removed: The fair value loss on contingent consideration affected the effective tax rate by an amount of $ 1.9 million in 2022 ($ 2.0 million and nil in 2021 and 2020, respectively).
+Added: 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).
Significant components of deferred taxes
6 unchanged sentences
Intangible assets
+Added: Liability from Royalty Financing Agreement
+Added: Interest carryforwards
Accrued expenses and other current liabilities
+Added: Defined benefit pension plan liability
Property, plant and equipment
Research and development tax credit carryforwards
−Removed: Interest carryforwards
Total deferred tax assets
3 unchanged sentences
Operating lease right-of-use assets
+Added: Property, plant and equipment
Other current assets and receivables
6 unchanged sentences
Changes recorded in equity
−Removed: Increase related to 2021 and 2020 Dutch tax reforms
−Removed: Valuation allowance assumed in Corlieve acquisition
−Removed: Release of valuation allowance related to expected current year and future periods recorded in profit and loss
+Added: Increase related to 2021 Dutch tax reforms
+Added: Valuation allowance assumed in uniQure France SAS acquisition
Other changes including currency translation adjustments
−Removed: The Company released the full valuation allowance against the Company’s net deferred assets in the United States as of December 31, 2020.
−Removed: Included within changes recorded in the statement of operations for the year ended December 31, 2020 are benefits of $ 1.2 million from the utilization of U.S.
−Removed: net operating loss carryforwards.
−Removed: The valuation allowance as of December 31, 2022 is primarily related to net operating loss carryforwards in the Netherlands.
+Added: 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.
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:
2 unchanged sentences
The Company has historically recorded a full valuation allowance.
−Removed: The Company evaluates all positive and negative evidence including future income from the CSL Behring Agreement in assessing the need for such a full valuation allowance.
−Removed: Management considered reversing taxable temporary differences, projected future taxable income and tax-planning strategies in making this assessment.
+Added: The Company evaluates all positive and negative evidence in assessing the need for a full valuation allowance.
+Added: Management considers reversing taxable temporary differences, projected future taxable income and tax-planning strategies in making this assessment.
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.
+Added: As of December 31, 2023, the tax treatment of the Royalty Agreement has not yet been agreed with the Dutch tax authorities.
+Added: A different tax treatment could result in a different categorization of temporary differences and an offsetting deferred tax asset.
The Company recorded $ 462.4 million of license revenue in May 2021 after the Closing of the CSL Behring transaction.
8 unchanged sentences
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 years 2020 and 2021 was 25.0 %.
−Removed: In December 2021, further changes were enacted that raised the corporate income tax rate from 25.0 % to 25.8 % from 2022 onwards.
+Added: The Dutch corporate tax rate for fiscal year 2021 was 25.0 %.
+Added: In December 2021, changes were enacted that raised the corporate income tax rate from 25.0 % to 25.8 % from 2022 onwards.
In June 2021 legislation was enacted allowing for an indefinite carryforward from fiscal year 2022 onwards of existing and future net operating loss carryforwards subject to a limit of offsetting taxable profit in excess of EUR 1.0 million to 50% of the taxable profit.
4 unchanged sentences
As of December 31, 2023, an estimated $ 31.1 million of net operating losses remain to be carried forward.
−Removed: These losses will expire between 2035 and 2037.
+Added: These net operating losses carried forward will expire in 2036 and 2037 except for $ 0.7 million which can be carried forward indefinitely with a deduction limited to 80% of taxable income in a given year.
The Company’s U.S.
−Removed: operations generated taxable income in the fiscal years 2018 to 2022.
+Added: operations generated taxable income in the fiscal years 2018 to 2021 and 2023.
The Company expects to continue to generate taxable income in the U.S.
1 unchanged sentence
Under the provision of the Internal Revenue Code, the U.S.
−Removed: net operating losses may become subject to an annual limitation in the event of certain cumulative exchange in the ownership interest of significant shareholders over a three-year period in excess of 50 percent, as defined under Section 382 and 383 of the Internal Revenue Code.
+Added: net operating losses carried forward may become subject to an annual limitation in the event of certain cumulative exchange in the ownership interest of significant shareholders over a three-year period in excess of 50 percent, as defined under Section 382 and 383 of the Internal Revenue Code.
This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities.
6 unchanged sentences
In addition, the Company is subject to a surcharge of 3.3 % of the 25.0 % standard corporate tax rate resulting in a combined rate of 25.8 %.
−Removed: The Company’s French operation has incurred losses since incorporation and is expected to continue incurring tax losses for the foreseeable future.
−Removed: The French operation as of December 31, 2022 has an estimated $ 23.3 million of taxable losses that are available for carry forward indefinitely.
+Added: The Company’s French operations have incurred losses since incorporation and are expected to continue incurring tax losses for the foreseeable future.
+Added: 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.
+Added: The Company recorded a partial valuation allowance during the year ended December 31, 2023.
+Added: No such valuation allowance was recorded in the years ended December 31, 2022 and 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 and tax-planning strategies in making this assessment.
Basic and diluted earnings per share
17 unchanged sentences
Non-vested RSUs and PSUs
−Removed: Employee share purchase plan
Total anti-dilutive ordinary share equivalents
6 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 “ Corlieve transaction ” and Note 4 “ 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 “ uniQure France SAS transaction ” and Note 5 “ Collaboration arrangements and concentration of credit risk ”, amongst others.
Related party transaction
−Removed: Between June 2015 and December 2020, BMS was considered a related party due to the combination of its equity investment in the Company, the warrants as well as the potential obligations arising from the expansion of collaboration targets.
−Removed: On December 1, 2020, the Company entered into the amended BMS CLA.
−Removed: All transactions subsequent to the effective date of the amended BMS CLA are considered to no longer be with a related party due to the elimination of the potential obligations related to additional Collaboration Targets (see Note 4 “Collaboration arrangements and concentration of credit risk” ) as well as the elimination of the BMS warrants (see Note 7, “Fair value measurement” ).
Subsequent events
−Removed: On January 31, 2023, the Company announced that it had entered into a global licensing agreement for a gene therapy for amyotrophic lateral sclerosis caused by mutations in superoxide dismutase 1 with Apic Bio.
−Removed: The Company made an initial cash payment of $ 10.0 million.
−Removed: In addition, the Company will pay Apic Bio up to $ 43.0 million in milestones upon achievement of regulatory approvals in the U.S.
−Removed: and Europe and pre-specified annual net sales, and a tiered royalty on net sales ranging from the mid-single digits to low double digits.
EXHIBIT INDEX
1 unchanged sentence
and Corlieve Therapeutics SAS (incorporated by reference to Exhibit 2.1 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ending on June 30, 2021 filed with the Securities and Exchange Commission).
+Added: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
Amended Articles of Association of the Company (incorporated by reference to Exhibit 3.1 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ending on June 30, 2021 filed with the Securities and Exchange Commission).
+Added: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934.
2014 Share Incentive Plan (incorporated by reference to Exhibit 4.3 of the Company's registration statement on Form S-8 (file no.
−Removed: 333-225629) filed with the Securities and Exchange Commission).
−Removed: Form of Inducement Share Option Agreement under 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.2 of the Company's annual report on Form 10-K (file no.
−Removed: 001-36294) for the period ending December 31, 2016 filed with the Securities and Exchange Commission).
−Removed: Form of Share Option Agreement under 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.3 of the Company's annual report on Form 10-K (file no.
−Removed: 001-36294) for the period ending December 31, 2016 filed with the Securities and Exchange Commission).
−Removed: Form of Restricted Stock Unit Award under the 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.4 of the Company's annual report on Form 10-K (file no.
−Removed: 001-36294) for the period ending December 31, 2017 filed with the Securities and Exchange Commission).
+Added: 333-225629) filed with the SEC on June 14, 2018).
Employment Agreement dated December 9, 2014 between uniQure, Inc.
and Matthew Kapusta (incorporated by reference to Exhibit 10.6 of the Company's annual report on Form 10-K (file no.
−Removed: 001-36294) for the period ending December 31, 2016 filed with the Securities and Exchange Commission).
+Added: 001-36294) for the year ended December 31, 2016 filed with the SEC on March 15, 2017).
Amendment to the Employment Agreement between uniQure, Inc.
and Matthew Kapusta, dated March 14, 2017 (incorporated by reference to Exhibit 10.7 of the Company's annual report on Form 10-K (file no.
−Removed: 001-36294) for the period ending December 31, 2016 filed with the Securities and Exchange Commission).
+Added: 001-36294) for the year ended December 31, 2016 filed with the SEC on March 15, 2017).
Amendment to the Employment Agreement between uniQure, Inc.
and Matthew Kapusta, dated October 26, 2017 (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 ending on September 31, 2017 filed with the Securities and Exchange Commission).
−Removed: 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 10.28 of the Company's registration statement on Form F-1 (file no.
−Removed: 333-193158) filed with the Securities and Exchange Commission).
+Added: 001-36294) for the period ended September 30, 2017 filed with the SEC on November 1, 2017).
+Added: Lease relating to 113 Hartwell Avenue, Lexington, Massachusetts, dated as of July 24, 2013, by and between uniQure Inc.
+Added: and King 113 Hartwell LLC (incorporated by reference to Exhibit 10.28 of the Company's registration statement on Form F-1 (file no.
+Added: 333-193158) filed with the SEC on January 2, 2014).
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.
−Removed: 333-193158) filed with the Securities and Exchange Commission).
+Added: 333-193158) filed with the SEC on January 2, 2014).
Deed of Assignment of Certain Assets and Liabilities of Amsterdam Molecular Therapeutics (AMT) Holding N.V., dated as of April 5, 2012, by and among Amsterdam Molecular Therapeutics (AMT) Holding B.V., Amsterdam Molecular Therapeutics (AMT) Holding IP B.V.
1 unchanged sentence
(incorporated by reference to Exhibit 10.30 of the Company's registration statement on Form F-1 (file no.
−Removed: 333-193158) filed with the Securities and Exchange Commission).
+Added: 333-193158) filed with the SEC on January 2, 2014).
Agreement for Transfer of Certain Assets and Liabilities of Amsterdam Molecular Therapeutics (AMT) Holding N.V., dated as of February 16, 2012, by and among Amsterdam Molecular Therapeutics (AMT) Holding B.V., Amsterdam Molecular Therapeutics (AMT) Holding IP B.V.
1 unchanged sentence
(incorporated by reference to Exhibit 10.31 of the Company's registration statement on Form F-1 (file no.
−Removed: 333-193158) filed with the Securities and Exchange Commission).
−Removed: Collaboration and License Agreement by and between uniQure Biopharma B.V.
−Removed: and Bristol-Myers Squibb Company dated April 6, 2015 (incorporated by reference to Exhibit 4.30 of the Company's annual report on Form 20-F (file no.
−Removed: 001-36294) filed with the Securities and Exchange Commission).
+Added: 333-193158) filed with the SEC on January 2, 2014).
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 (file no.
−Removed: 001-36294) filed with the Securities and Exchange Commission).
+Added: 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.
+Added: 001-36294) filed with the SEC on April 7, 2015).
Lease relating to Paasheuvelweg 25, dated as of March 7, 2016, by and between 52 IFH GmbH & Co.
1 unchanged sentence
(incorporated by reference to Exhibit 10.36 of the Company's annual report on Form 10-K (file no.
−Removed: 001-36294) for the period ending December 31, 2016 filed with the Securities and Exchange Commission).
−Removed: Employment Agreement dated July 15, 2017 between uniQure biopharma B.V.
−Removed: and Christian Klemt (incorporated by reference to Exhibit 10.4 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ending on June 30, 2017 filed with the Securities and Exchange Commission).
+Added: 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.
−Removed: (incorporated by reference to Exhibit 10.1 of the Company’s periodic report on Form 8-K (file no.
−Removed: 001-36294) filed on October 19, 2017 with the Securities and Exchange Commission).
+Added: (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 October 19, 2017).
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 Securities and Exchange Commission) filed on November 15, 2018.
+Added: 001-36294) filed with the SEC on November 15, 2018).
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 Securities and Exchange Commission) filed on June 14, 2018.
+Added: 333-225629) filed with the SEC on June 14, 2018).
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 ending on June 30, 2019 filed with the Securities and Exchange Commission).
−Removed: Form of Share Option Agreement, effective June 18, 2019, under the 2014 Share Incentive Plan (incorporated by reference to Exhibit 10.43 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ending on June 30, 2019 filed with the Securities and Exchange Commission).
−Removed: Amended and Restated Employment Agreement, executed September 17, 2019, by and between the Company and Dr.
−Removed: Kuta (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 Securities and Exchange Commission) filed on September 20, 2019.
−Removed: Amended and Restated Employment Agreement, executed March 1, 2020 by and between uniQure biopharma B.V.
−Removed: and Christian Klemt (incorporated by reference to Exhibit 10.49 of the Company’s annual report on Form 10-K for the year ended December 31, 2019 (file no.
−Removed: 0001-36294) filed with the Securities and Exchange commission).
−Removed: Amended and Restated Employment Agreement, executed March 1, 2020 by and between uniQure Inc.
−Removed: Robert Gut (incorporated by reference to Exhibit 10.50 of the Company’s annual report on Form 10-K for the year ended December 31, 2019 (file no.
−Removed: 0001-36294) filed with the Securities and Exchange commission).
+Added: 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.
and CSL Behring LLC dated June 24, 2020 (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 ending on June 30, 2020 filed with the Securities and Exchange Commission).
−Removed: Separation agreement, executed August 25, 2020, by and between uniQure biopharma B.V.
−Removed: and Sander van Deventer (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 ending on September 30, 2020 filed with the Securities and Exchange Commission).
−Removed: Separation agreement, executed August 25, 2020, by and between uniQure Inc.
−Removed: and Robert Gut (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 ending on September 30, 2020 filed with the Securities and Exchange Commission).
+Added: 001-36294) for the period ended June 30, 2020 filed with the SEC on July 30, 2020).
Employment Agreement, executed September 14, 2020, by and between uniQure Inc.
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 ending on September 30, 2020 filed with the Securities and Exchange Commission).
−Removed: Amendment to Collaboration and License Agreement by and between uniQure biopharma B.V.
−Removed: and Bristol-Myers Squibb Company dated December 1, 2020 (incorporated by reference to Exhibit 10.57 of the Company’s annual report on Form 10-K for the year ended December 31, 2020 (file no.
−Removed: 0001-36294) filed with the Securities and Exchange commission).
−Removed: Amendment No.
−Removed: 2 to Second Amended and Restated Loan and Security Agreement as of January 29, 2021, by and among uniQure biopharma B.V., uniQure Inc., uniQure IP B.V., the Company and Hercules Capital Inc.
−Removed: (incorporated by reference to Exhibit 10.58 of the Company’s annual report on Form 10-K for the year ended December 31, 2020 (file no.
−Removed: 0001-36294) filed with the Securities and Exchange commission).
−Removed: Cooperation Agreement, dated as of April 16, 2021, by and among uniQure N.V., ForUniqure B.V., Forbion 1 Management B.V., Forbion International Management B.V., and Forbion Capital Partners Management Holding B.V.
−Removed: (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 ending on March 31, 2021 filed with the Securities and Exchange Commission).
−Removed: 2014 Share Incentive Plan, Amended and Restated, effective as of June 16, 2021 (incorporated by reference to Exhibit 4.1 of the Company’s quarterly report on Form 10-Q (file no.
−Removed: 001-36294) for the period ending on June 30, 2021 filed with the Securities and Exchange Commission).
+Added: 001-36294) for the period ended September 30, 2020 filed with the SEC on October 27, 2020).
+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).
Employment Agreement, effective May 17, 2021, by and between uniQure biopharma B.V.
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 ending on June 30, 2021 filed with the Securities and Exchange Commission).
+Added: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
Equity Side Letter, effective May 17, 2021, by and between uniQure N.V.
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 ending on June 30, 2021 filed with the Securities and Exchange Commission).
+Added: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
Amended and Restated Employment Agreement, effective June 15, 2021, by and between uniQure biopharma B.V.
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 ending on June 30, 2021 filed with the Securities and Exchange Commission).
−Removed: Consent and Amendment No.
−Removed: 3 to Second Amended and Restated Loan and Security Agreement, dated July 30, 2021, by and among the Registrant, Hercules Capital Inc., and the other parties named therein (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 ending on September 30, 2021 filed with the Securities and Exchange Commission).
+Added: 001-36294) for the period ended June 30, 2021 filed with the SEC on July 26, 2021).
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 Securities and Exchange Commission).
+Added: 001-36294) filed with the SEC on February 25, 2022).
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 Securities and Exchange Commission).
+Added: 001-36294) filed with the SEC on February 25, 2022).
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 Securities and Exchange Commission).
+Added: 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.
−Removed: 001-36294) filed with the Securities and Exchange Commission).
+Added: 001-36294) filed with the SEC on February 25, 2022).
Lease Agreement relating to 20 Maguire Road, Lexington, Massachusetts, dated as of December 22, 2021, by and between uniQure Inc.
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 Securities and Exchange Commission).
+Added: 001-36294) filed with the SEC on February 25, 2022).
Lease Agreement relating to 91 Hartwell Avenue, Lexington, Massachusetts, dated as of February 1, 2022, by and between uniQure Inc.
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 Securities and Exchange Commission).
−Removed: Code of Ethics (incorporated by reference to Exhibit 14.1 of the Company's annual report on Form 10-K (file no.
−Removed: 001-36294) for the period ending December 31, 2016 filed with the Securities and Exchange Commission).
+Added: 001-36294) filed with the SEC on February 25, 2022).
+Added: Amendment No.
+Added: 1 to Third Amended and Restated Loan and Security Agreement, dated of May 12, 2023, 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 10.1 of the Company’s quarterly report on Form 10-Q for the period ended June 30, 2023 (file no.
+Added: 001-36294) filed with the SEC on August 1, 2023).
+Added: Royalty Purchase Agreement, dated May 12, 2023, by and between uniQure biopharma B.V.
+Added: and HemB SPV, L.P.
+Added: (incorporated by reference to Exhibit 10.2 of the Company’s quarterly report on Form 10-Q for the period ended June 30, 2023 (file no.
+Added: 001-36294) filed with the SEC on August 1, 2023).
+Added: Termination and Consulting Agreement, effective October 4, 2023, by and between uniQure Inc.
+Added: and Ricardo Dolmetsch, Ph.D.
+Added: (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.
+Added: 001-36294) filed with the SEC on November 7, 2023).
+Added: Employment Agreement dated July 30, 2021 between Corlieve Therapeutics AG and Richard Porter.
+Added: First Amended Employment Agreement dated April 1, 2022 between Corlieve Therapeutics AG and Richard Porter.
+Added: Letter Agreement dated October 5, 2023, by and between Richard Porter and Corlieve Therapeutics AG.
+Added: Employment Agreement dated June 13, 2023 between uniQure, Inc.
+Added: and Jeannette Potts.
+Added: Code of Ethics.
Subsidiaries of the Company.
5 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
+Added: Compensation Clawback Policy.
The following materials from the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, formatted in Inline XBRL (eXtensible Business Reporting Language):
5 unchanged sentences
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
−Removed: UNIQURE, N.V.
February 28, 2024
5 unchanged sentences
Christian Klemt
−Removed: Chief Financial Officer (Principal Financial Officer)
+Added: Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
POWER OF ATTORNEY
6 unchanged sentences
/s/ CHRISTIAN KLEMT
−Removed: Chief Financial Officer (Principal Financial Officer)
+Added: Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
February 28, 2024
20 unchanged sentences
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.