What changed in this filing

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Item 9A. Controls and Procedures

2021-03-01 compared with 2020-03-02 · 429 added, 535 removed, 878 unchanged (52% of the section changed)

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Changes in internal control over financial reporting

During the fourth quarter of 2019, there was no change in our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

During the fourth quarter of 2020, there were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

We have not experienced any material impact to our internal controls over financial reporting even though a large group of our employees are working remotely due to the COVID-19 pandemic.

We are continually monitoring and assessing the impact COVID-19 has on the operating effectiveness of our internal controls.

Other Information

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Opinions on the Consolidated Financial Statements and Internal Control Over Financial Reporting

We have audited the accompanying consolidated balance sheet of uniQure N.V.

and subsidiaries (the Company) as of December 31, 2019, the related consolidated statements of operations and comprehensive loss, shareholders’ equity, and cash flows for the year then ended, and the related notes (collectively, the consolidated financial statements).

We have audited the accompanying consolidated balance sheets of uniQure N.V.

and subsidiaries (the Company) as of December 31, 2020 and 2019, the related consolidated statements of operations and comprehensive loss, shareholders’ equity, and cash flows for the years then ended, and the related notes (collectively, the consolidated financial statements).

We also have audited the Company’s internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2019, and the results of its operations and its cash flows for the year then ended, in conformity with U.S.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2020 and 2019, and the results of its operations and its cash flows for the years then ended, in conformity with U.S.

generally accepted accounting principles.

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Change in Accounting Principle

As discussed in Note 6 to the consolidated financial statements, the Company has changed its method of accounting for leases as of January 1, 2019 due to the adoption of ASC 842, Leases .

As discussed in Note 6, to the consolidated financial statements, the Company changed its method of accounting for leases as of January 1, 2019 due to the adoption of ASC 842, Leases .

Basis for Opinions

The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Controls Over Financial Reporting.

Our responsibility is to express an opinion on the Company’s consolidated financial statements and an opinion on the Company’s internal control over financial reporting based on our audits.

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Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.

Our audit of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.

Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk.

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(1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which they relate.

Assessment of progress made towards completion of the active targets as part of the performance obligation for license revenue

As described in Notes 2.3.19 and 2.3.23 to the consolidated financial statements, the Company primarily generates license revenue.

In 2015 uniQure entered into a collaboration agreement with BMS.

uniQure received substantial upfront and target designation payments in relation to the collaboration predominantly in 2015.

uniQure recognizes the above payments as license revenue in relation to progress made towards completion of the performance obligation.

We identified the assessment of progress made towards completion of the performance obligation as a critical audit matter due to the high degree of subjective auditor judgement required to evaluate the key assumptions used in the Company’s model to estimate progress made towards completion, which included the following:

– estimated time required to provide services during the different phases of preclinical and clinical development of the active target;

– probability of successfully completing each such phase;

– total expected performance period based on its measure of progress towards the completion of activities.

The primary procedures we performed to address this critical audit matter included the following:

- We tested certain internal controls over the Company’s process to estimate progress towards completion for license revenue, including controls over the development of the license revenue recognition model, estimated time to complete each phase, estimate of the probability of successfully completing each phase, and the estimate of total expected performance period to complete the development of the active targets.

- We assessed the Company’s estimated progress towards completion as per its internally developed model based on an industry wide study by reference to the Company’s progress to date and the steps still required to be completed as per the collaboration agreement.

- We performed sensitivity analyses over the progress measured and total expected performance period to assess the impact on the Company’s determination of license revenue recognized.

- We reviewed the Company’s joint steering committee communications and collaboration agreement provisions and performed inquiries of the Company on the progress made.

- We assessed the Company’s estimated probability of moving to the next phase as per its internally developed model based on an industry wide study by reference to the joint steering committee communications and inquiries of the Company.

The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Assessment of the satisfaction of the license revenue performance obligation within the BMS collaboration and license agreement

As discussed in Notes 2.3.18 and 3 to the consolidated financial statements, uniQure biopharma B.V., a subsidiary of uniQure N.V.

(the Company) entered into an amended collaboration and license agreement (CLA) with Bristol-Myers Squibb Company (BMS) on December 1, 2020.

Based on the terms of the amended agreement, the Company determined that it materially satisfied its performance obligation in relation to the license revenue as of December 1, 2020, and as such recorded the residual balance of unrecognized license revenue of $27.8 million in profit and loss as license revenues from related party.

We identified the assessment of the satisfaction of the license revenue performance obligation as a critical audit matter.

A high degree of subjective, complex auditor judgement was required in assessing if the remaining rights of the license revenue performance obligation were materially satisfied as of December 1, 2020.

The following are the primary procedures we performed to address this critical audit matter:

- We evaluated the design and tested the operating effectiveness of an internal control related to the evaluation of the performance obligation and when it was materially satisfied.

- In order to assess that the remaining rights of the license revenue performance obligation were materially satisfied, we examined the amended collaboration and license agreement between the Company and BMS.

- In order to assess the satisfaction of the performance obligation, we examined minutes of joint steering committee meetings between the Company and BMS, evaluated the services delivered and performed interviews with the Company’s finance and business operations department.

/s/ KPMG Accountants N.V.

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Opinion on the Financial Statements

We have audited the consolidated balance sheet of uniQure N.V.

and its subsidiaries (the “Company”) as of December 31, 2018, and the related consolidated statements of operations and comprehensive loss, of shareholders’ equity, and of cash flows for each of the two years in the period ended December 31, 2018, including the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2018, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018 in conformity with accounting principles generally accepted in the United States of America.

We have audited the consolidated statements of operations and comprehensive loss, of shareholders’ equity and of cash flows of uniQure N.V.

and its subsidiaries (the “Company”) for the year ended December 31, 2018, including the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the results of operations and cash flows of the Company for the year ended December 31, 2018 in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

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federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB.

We conducted our audit of these consolidated financial statements in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.

We believe that our audits provide a reasonable basis for our opinion.

Amsterdam, the Netherlands, February 28, 2019

We believe that our audit provides a reasonable basis for our opinion.

PricewaterhouseCoopers Accountants N.V.

We served as the Company’s auditor from 2006 to 2019, which includes periods before the Company became subject to SEC reporting requirements.

Amsterdam, the Netherlands

February 28, 2019

We served as the Company's auditor from 2006 to 2019.

CONSOLIDATED BALANCE SHEET S

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Cash and cash equivalents

Accounts receivable and accrued income from related party

Accounts receivables

Accounts receivable from related party

Prepaid expenses

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Restricted cash

Deferred tax asset

Total non-current assets

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Current portion of operating lease liabilities

Current portion of deferred rent (see note 2.3.23)

Current portion of deferred revenue

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Operating lease liabilities, net of current portion

Deferred rent, net of current portion (see note 2.3.23)

Deferred revenue, net of current portion

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Additional paid-in-capital

Accumulated other comprehensive loss

Accumulated other comprehensive income / (loss)

Accumulated deficit

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Foreign currency (losses) / gains, net

Other non-operating (losses) / gains, net

Loss before income tax expense

Income tax (expense) / benefit

Other comprehensive income / (loss), net of income tax:

Other non-operating gains / (losses), net

Loss before income tax income / (expense)

Income tax income / (expense)

Other comprehensive income / (loss):

Foreign currency translation adjustments net of tax impact of nil for the year ended December 31, 2020 (2019:

$( 0.2 ) million and 2017:

nil and 2018:

$( 0.2 ) million)

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(loss)/income

(in thousands, except share and per share amounts)

(in thousands, except share data)

Balance at December 31, 2017

Cumulative effect of retroactive implementation of ASC 606 Revenue recognition

Loss for the period

Other comprehensive income

Other comprehensive loss

Follow-on public offering

Shares issued as consideration in a business combination

Exercises of share options

Exercises of convertible loan warrants

Restricted and performance share units distributed during the period

Share-based compensation expense

Issuance of ordinary shares relating to employee stock purchase plan

Balance at December 31, 2018

Cumulative effect of retroactive implementation of ASC 606 Revenue recognition

Loss for the period

Other comprehensive loss

Other comprehensive income

Follow-on public offering

Hercules warrants exercise

Exercise of share options

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Other comprehensive income

Follow-on public offering

Hercules warrants exercise

Exercise of share options

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Unrealized foreign exchange losses / (gains)

Change in deferred tax expense

Deferred tax (income) / expense

Change in lease incentives

Change in deferred revenue

Changes in operating assets and liabilities:

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Accrued expenses, other liabilities, and operating leases

Deferred revenue

Net cash used in operating activities

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Proceeds from issuance of shares related to employee stock option and purchase plans

Proceeds from exercises of convertible loan warrants

Proceeds from public offering of shares, net of issuance costs

Proceeds from loan increment

Contingent consideration payment

Proceeds from exercise of warrants

Net cash generated from financing activities

Currency effect cash, cash equivalents and restricted cash

Net increase in cash, cash equivalents and restricted cash

Currency effect on cash, cash equivalents and restricted cash

Net (decrease) / increase in cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash at beginning of period

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Cash paid for interest

Non-cash increases (decreases) in accounts payables related to purchases of intangible assets and property, plant and equipment

Non-cash increase / (decrease) in accounts payables and accrued expenses and other current liabilities related to purchases of intangible assets and property, plant, and equipment

The accompanying notes are an integral part of these consolidated financial statements.

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The Company is a leader in the field of gene therapy and seeks to deliver to patients suffering from rare and other devastating diseases single treatments with potentially curative results.

The Company’s business was founded in 1998 and was initially operated through its predecessor company, Amsterdam Molecular Therapeutics (AMT) Holding N.V (“AMT”).

The Company’s business was founded in 1998 and was initially operated through its predecessor company, Amsterdam Molecular Therapeutics Holding N.V (“AMT”).

In 2012, AMT undertook a corporate reorganization, pursuant to which uniQure B.V.

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2.1 Basis of preparation

The Company prepared its consolidated financial statements in compliance with generally accepted accounting principles in the U.S.

The Company prepared its consolidated financial statements in compliance with generally accepted accounting principles in the United States (“U.S.

Any reference in these notes to applicable guidance is meant to refer to authoritative U.S.

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The preparation of consolidated financial statements, in conformity with U.S.

GAAP and SEC rules and regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period.

Estimates and assumptions are primarily made in relation to revenue recognition in the determination and measurement of performance obligations and assessment of the performance period over which license revenue is recognized, income taxes, including the realization of deferred tax assets, fair value of derivative financial instruments, share-based compensation, measurement of accrued expenses which have not yet been invoiced as of the balance sheet date and business combinations including contingent consideration payable.

GAAP and Securities and Exchange Commission (“SEC”) rules and regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period.

Estimates and assumptions are primarily made in relation to the treatment of the commercialization and license agreement entered into between the Company and CSL Behring LLC (“CSL Behring Agreement”), the December 1, 2020, amendment (“amended BMS CLA”) of the 2015 collaboration and license agreement (“BMS CLA”) between the Company and Bristol-Myers Squibb (“BMS”), share-based payments, valuation allowances for deferred tax assets, and accounting for operating leases under ASC 842.

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.

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2.3.3 Foreign currency translation

The functional currency of the Company and each of its entities (with the exception of uniQure Inc.) is the euro (€).

The functional currency of the Company and each of its entities (except for uniQure Inc.) is the euro (€).

This represents the currency of the primary economic environment in which the entities operate.

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The exchange differences arising on translation for consolidation are recognized in “accumulated other comprehensive income / loss”.

On disposal of a foreign operation, the component of other comprehensive income / loss relating to that particular foreign operation is recognized in profit or loss.

On disposal of a foreign operation, the component of other comprehensive income / loss relating to that foreign operation is recognized in profit or loss.

2.3.4 Fair value measurement

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The three levels of the fair value hierarchy are described below:

● Level 1 - Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

● Level 1 - Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company can access at the measurement date.

● Level 2 - Valuations based on quoted prices for similar assets or liabilities in markets that are not active or models for which the inputs are observable, either directly or indirectly.

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The carrying amount of cash and cash equivalents, accounts receivable from collaborators, prepaid expenses, other assets, accounts payable, accrued expenses and other current liabilities reflected in the consolidated balance sheets approximate their fair values due to their short-term maturities.

2.3.5 Business combination

On July 31, 2014, the Company closed its acquisition of InoCard GmbH (“InoCard”).

This transaction was accounted for as a business combination under the acquisition method of accounting.

Accordingly, the tangible and intangible assets acquired, and liabilities assumed were recorded at fair value as of the date of acquisition, with the excess purchase price recorded as goodwill.

The estimated fair values of the assets acquired, and liabilities assumed were determined using the methods discussed in the following paragraphs and required significant judgment and estimates, which could materially differ from actual values and fair values determined using different methods or assumptions.

Goodwill represents the excess of the purchase price over the fair value of the net assets acquired when accounted for using the acquisition method of accounting for business combinations.

Goodwill is not amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis in the fourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s reporting unit below its carrying amount.

The Company has not recognized any impairment charges related to goodwill.

Acquired research and development

Acquired research and development (“Acquired R&D”) represents the fair value assigned to intangible assets in incomplete research projects that the Company acquires through business combinations.

The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion, abandonment of the projects or when the research findings are commercialized through a revenue-generating project.

Upon successful completion or commercialization of a project, uniQure will make a determination as to the then useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization.

In case of abandonment, the asset will be written-off.

See note 6, “Intangible assets,” for additional information.

Contingent consideration

Each reporting period, the Company revalues the contingent consideration obligations associated with this business combination to their fair value and records changes in the fair value within research and development expenses.

Changes in contingent consideration result from changes in assumptions regarding the probabilities of successful achievement of related milestones, the estimated timing in which milestones are achieved and the discount rate used to estimate the fair value of the liability.

Payments made soon after the acquisition date are recorded as cash flows from financing activities, and payments, or the portion of the payments, not made soon after the acquisition date are recorded as cash flows from operating activities.

See note 4, “Fair value measurement,” for additional information.

2.3.5 Notes to the consolidated statements of cash flows

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The Company follows the provisions of ASC 260, Earnings Per Share .

In accordance with these provisions, loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding during the period.

Diluted net loss per share reflects the dilution that would occur if share options or warrants to issue common stock were exercised, or performance or restricted share units were distributed.

However, potential common shares are excluded if their effect is anti-dilutive.

In accordance with these provisions, loss per share is calculated by dividing net loss by the weighted average number of ordinary shares outstanding during the period.

Diluted net loss per share reflects the dilution that would occur if share options or warrants to issue ordinary shares were exercised, or performance or restricted share units were distributed.

However, potential ordinary shares are excluded if their effect is anti-dilutive.

The Company currently has no dilutive securities due to the net loss position and as such, basic and diluted net loss per share are the same for the periods presented.

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The Company performs the same quantitative analysis discussed above for long-lived assets and finite-lived intangible assets.

2.3.10 Intangible assets

Acquired licenses have a finite useful life and are carried at cost less accumulated amortization and impairment losses.

Amortization is calculated using the straight-line method to allocate the cost of licenses over their estimated useful lives (generally 20 years unless a license expires prior to that date).

2.3.9 Property, plant, and equipment

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Between 3 – 5 years

2.3.10 Leases

The Company adopted ASC 842 using the modified retrospective approach with an effective date as of the beginning of the Company’s fiscal year, January 1, 2019, to operating leases that existed on that date.

Comparative financial information related to profit and loss and cash flows for the twelve-month period ended December 31, 2018, was not recast under the new standard, and continues to be presented under ASC 840.

The Company measured lease liabilities at the present value of the future lease payments as of January 1, 2019.

The Company used an incremental borrowing rate to discount the lease payments.

The Company derived the discount rate, adjusted for differences such as in the term and payment patterns, from the Company’s loan from Hercules Technology Growth Capital, Inc (“Hercules Capital”), which was refinanced immediately prior to the January 1, 2019 adoption date in December 2018.

The right-of-use asset is valued at the amount of the lease liability reduced by the remaining December 31, 2018 balance of lease incentives received.

The lease liability is subsequently measured at the present value of the future lease payments as of the reporting date with a corresponding adjustment to the right-to-use asset.

Absent a lease modification, the Company will continue to utilize the January 1, 2019, incremental borrowing rate.

The Company recognizes lease cost on a straight-line basis and presents these costs as operating expenses within the Consolidated statements of operations and comprehensive loss.

The Company presents lease payments and landlord incentive payments within cash flows from operations within the Consolidated statements of cash flows.

The financial results for the years ended December 31, 2020 and 2019 are presented in accordance with ASC 842, while the financial results for the year ended December 31, 2018 are presented in accordance with the Company’s historical accounting policy based on ASC 840.

2.3.11 Other (non) current assets

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Deposits are classified as restricted cash and primarily relate to facility leases.

2.3.13 Accounts receivable

Accounts receivables are amounts due from services provided to the Company’s collaboration partner and are purely trade receivables.

Contract assets are presented in other current assets or as other non-current assets based on the timing of the right to consideration.

2.3.12 Prepaid expenses

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The related expense will be recognized in the subsequent period as incurred.

2.3.13 Accounts receivable

Accounts receivables include amounts due from services provided to the Company’s collaboration partner as well as unconditional rights to consideration from its collaboration partners.

2.3.14 Accounts payable and accrued expenses

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Accrued expenses are recognized for goods or services that have been acquired in the ordinary course of business.

Contract liabilities are presented in accounts payable and accrued expenses.

2.3.15 Long-term debt

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The Company accounts for its share-based compensation awards in accordance with ASC 718, Compensation-Stock Compensation.

All of the Company’s share-based compensation plans for employees are equity-classified.

All the Company’s share-based compensation plans for employees are equity-classified.

ASC 718 requires all share-based compensation to employees, including grants of employee options, restricted share units, performance share units and modifications to existing instruments, to be recognized in the consolidated statements of operations and comprehensive loss based on their grant-date fair values, net of an estimated forfeiture rate, over the requisite service period.

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2.3.18 Revenue recognition

The Company primarily generates revenue from its collaboration, research and license agreements with its collaboration partners for the development and commercialization of its product candidates.

Revenue recognition in accordance with ASC 606:

The Company primarily generates revenue from its collaboration, research, and license agreements with its collaboration partner BMS for the development and commercialization of product candidates.

The Company initially entered into these agreements in 2015 and amended them in 2020.

On January 1, 2018, the Company adopted new revenue recognition policies in accordance with ASC 606 using the modified retrospective approach.

The new revenue recognition policies replace the revenue recognition standards under ASC 605.

The Company elected to implement ASC 606 by applying it to active collaboration arrangements as of the Initial Application Date and to record a cumulative adjustment of revenue previously recognized to accumulated loss as of December 31, 2017.

See note 2.3.23 “Recently Adopted Accounting Pronouncements” and note 3 “Collaboration arrangements and concentration of credit risk” for additional information.

Revenue recognition for the year ended December 31, 2017:

During the year ended December 31, 2017 the Company applied ASC 605.

The Company recognized revenue when earned and realized or realizable.

Accordingly, revenue was recognized for each unit of accounting when all of the following criteria were met:

● Persuasive evidence of an arrangement exists;

● Delivery has occurred or services have been rendered;

● The seller´s price to the buyer is fixed or determinable;

● Collectability is reasonably assured.

Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s consolidated balance sheets.

Multiple element arrangements were analyzed to determine whether the deliverables within the agreement can be separated or whether they must be accounted for as a single unit of accounting.

Deliverables under an agreement are required to be accounted for as separate units of accounting provided that (i) a delivered item has value to the customer on a stand-alone basis;

and (ii) if the agreement includes a general right of return relative to the delivered item, the delivery or performance of the undelivered item is considered probable and substantially in the control of the vendor.

The allocation of consideration amongst the deliverables under the agreement is derived using a “best estimate of selling price” if vendor specific objective evidence and third-party evidence of fair value are not available.

If the delivered element does not have stand-alone value or if the fair value of any of the undelivered elements cannot be determined, the arrangement is accounted for as a single unit of accounting.

License revenues under ASC 605

License revenues consisted of up-front payments, target selection payments, milestone payments and royalties.

Up-front and target selection payments

Up-front payments, target selection payments or similar non-refundable payments were initially reported as deferred revenue on the consolidated balance sheets and were recognized as revenue on a straight-line basis over the period of the performance obligation.

The estimated period of the performance obligation is re-assessed at each balance sheet date.

Milestone payments and royalties

Research-based milestone payments were recognized as revenues either on achievement of such milestones if the milestones were considered substantive or over the period the Company has continuing performance obligations, if the milestones were not considered substantive.

When determining if a milestone is substantive, the Company considered the following factors:

● The degree of certainty in achieving the milestone;

● The frequency of milestone payments;

● The Company’s efforts, which result in achievement of the milestone;

● The amount of the milestone payment relative to the other deliverables and payment terms;

● Whether the milestone payment is related to future performance or deliverables.

Sales-based milestone payments and royalties were recognized in earnings when earned.

Collaboration revenue under ASC 605

Collaboration revenue consists of revenue generated from collaborative research and development arrangements.

Services may include the provision of Company staff, consultants or other third-party vendors engaged by the Company in relation to a collaboration program and the manufacturing of gene therapeutic products to the extent these were reimbursed through the respective collaborative research and development program.

Collaboration revenues, which were related to reimbursements from collaborators for the Company’s performance of research and development services under the respective agreements, were recognized on the basis of labor hours valued at a contractually agreed rate.

Collaboration revenues include reimbursements for related out-of-pocket expenses.

Cost reimbursements to which the Company was entitled under agreements were recognized as collaboration revenues in the same quarter of the recorded cost they were intended to compensate.

The Company evaluated the initial BMS CLA and determined that its performance obligations were as follows:

● Providing pre-clinical research activities (“Collaboration Revenue”);

● Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”);

● Providing access to its technology and know-how in the field of gene therapy as well as actively contributing to the target selection, the collaboration as a whole, the development during the target selection, the pre-clinical and the clinical phase through participating in joint steering committee and other governing bodies (“License Revenue”).

As further discussed in Note 3, “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.

The Company may still be required to provide pre-clinical research activities or clinical and commercial manufacturing services when BMS exercises its options for those services.

License Revenue

Until the December 2020 amendment of the BMS CLA the Company recognized License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services.

Following the December 2020 amendment of the BMS CLA the Company’s performance was materially completed and it had satisfied its performance obligation (see Note 3, “Collaboration arrangements and concentration of credit risk”, for a detailed discussion).

Collaboration and Manufacturing Revenue

The Company recognizes Collaboration Revenues associated to optional work orders it receives from BMS to provide analytical development and process development activities that are reimbursable by BMS in accordance with the BMS CLA as well as the amended BMS CLA.

BMS and the Company entered into a Master Clinical Supply Agreement in April 2017 for the Company to supply gene therapy products during the clinical phase as well as into a binding term sheet to supply gene therapy products during the commercial phase to BMS.

In December 2020, BMS and the Company also entered into a Research Supply Agreement.

Revenues from product sales will be recognized when earned.

The Company will provide these services as it receives optional work orders from BMS in relation to such services.

2.3.19 Other income, other expense

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The Company’s other income also consists of income from the subleasing of the Amsterdam facility while other expense consists of expenses incurred in relation to the subleasing income.

Income from releasing outstanding deferred revenue in relation to the termination of the collaboration with Chiesi in 2017 is presented as other income in 2017 with no such income in 2018 and 2019.

Cost incurred in 2017 in relation to terminating the marketing of its Glybera program, as well as costs associated with exiting its prior Amsterdam facilities and its Heidelberg site are presented as other expenses with no such expenses in 2018 and 2019.

2.3.20 Research and development expenses

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In addition, research and development expenses consist of start-up and validation costs related to the Company’s Lexington facility and the development and improvement of the Company’s manufacturing processes and methods.

Furthermore, research and development costs include costs of materials and costs of intangible assets purchased from others for use in research and development activities.

The costs of intangibles that are purchased from others for a particular research and development project and that have no alternative future uses (in other research and development projects or otherwise) are expensed as research and development costs at the time the costs are incurred or at the time when no alternative future use is identified.

2.3.21 Income taxes

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Deferred tax assets and liabilities are determined based on the difference between the financial statement carrying amount and the tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.

Valuation allowances are provided, if based upon the weight of available evidence, it is more-likely-than-not that some or all of the deferred tax assets will not be realized.

Valuation allowances are provided, if based upon the weight of available evidence, it is more-likely-than-not that some or all the deferred tax assets will not be realized.

The benefits of tax positions are recognized only if those positions are more likely than not, based on the technical merits, to be sustained upon examination.

Recognized tax positions are measured at the largest amount of tax benefit that is greater than 50 percent likely of being realized upon settlement.

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2.3.22 Recently Adopted Accounting Pronouncements

ASC 842 - Leases (Topic 842)

In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)”.

In July 2018, the FASB issued ASU No.

2018-10, “Codification Improvements to Topic 842, Leases” (ASU 2018-10), which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU No.

2018-11, “Leases (Topic 842) – Target Improvements” (ASU 2018-11), which address implementation issues related to the new lease standard.

The standard is effective for interim and annual reporting periods beginning after December 15, 2018.

Under the new standard, lessees are required to recognize the right-of-use assets and lease liabilities that arise from operating leases on the Consolidated balance sheet.

The Company adopted the standard using the modified retrospective approach with an effective date as of the beginning of the Company’s fiscal year, January 1, 2019, to operating leases that existed on that date.

Prior year comparative financial information was not recast under the new standard and continues to be presented under ASC 840.

The Company elected to utilize the package of practical expedients available for expired or existing contracts which allowed the Company to carryforward historical assessments of (1) whether contracts are or contain leases, (2) lease classification, and (3) initial direct costs.

The Company performed an assessment and identified the lease facilities as leases to be accounted for under ASC 842 as of January 1, 2019.

The Company elected to implement ASC 842 by applying the modified retrospective approach, which allows the Company to restrict the application of the new guidance to operating leases as of January 1, 2019.

The impact of implementing ASC 842 is summarized below:

- Recognized a $ 19.0 million operating right-of-use asset and a $ 28.1 million operating lease liability in relation to the facilities leased at the Amsterdam and Lexington sites in the Consolidated balance sheet as of January 1, 2019;

- Presented deferred rent of $ 9.1 million as of December 31, 2018, as a reduction of the right-of-use asset as from January 1, 2019 onwards in the Consolidated balance sheet and as a change within operating cash flows within accrued expense, other liabilities and operating leases;

The Company measured the lease liability at the present value of the future lease payments as of January 1, 2019.

The Company used an incremental borrowing rate to discount the lease payments.

The Company derived the discount rate, adjusted for differences such as in the term and payment patterns, from the Company’s loan from Hercules Capital, which was refinanced immediately prior to the January 1, 2019 adoption date in December 2018.

The right-of-use asset is valued at the amount of the lease liability reduced by the remaining December 31, 2018 balance of lease incentives received.

The lease liability is subsequently measured at the present value of the future lease payments as of the reporting date with a corresponding adjustment to the right-to-use asset.

Absent a lease modification, the Company will continue to utilize the January 1, 2019, incremental borrowing rate.

The Company will continue to recognize lease cost on a straight-line basis and will continue to present these costs as operating expenses within the Consolidated statements of operations and comprehensive loss.

The Company will continue to present lease payments and landlord incentive payments within cash flows from operations within the Consolidated statements of cash flows.

The financial results for year ended December 31, 2019, is presented under the new standard, while the comparative periods presented are not adjusted and continue to be reported in accordance with the Company’s historical accounting policy.

Refer to note 6, “Right-of-use asset and lease liabilities” for further information.

ASC 606 Revenue from Contracts with Customers

Effective January 1, 2018 the Company adopted new revenue recognition policies in accordance with ASC 606 using the modified retrospective approach.

The new revenue recognition policies replace the revenue recognition standards under ASC 605.

The Company elected to implement ASC 606 by applying it to active collaboration arrangements as of January 1, 2018 and to record a cumulative adjustment of revenue previously recognized to the accumulated loss as of December 31, 2017.

The impact of implementing ASC 606 is summarized below:

- Recognized $ 7.5 million of license revenue during the twelve months ended December 31, 2018, related to the collaboration with BMS compared to $ 4.2 million that would have been recognized in accordance with the previous revenue recognition policies;

- Continued to present revenue recognized during the twelve months ended December 31, 2017 and December 31, 2016, in accordance with the previous revenue recognition policies;

- Decreased the accumulated loss by $ 24.9 million as of January 1, 2018 and decreased deferred revenue as of the same date by $ 24.9 million.

In accordance with the previous revenue recognition policies the Company had concluded that the BMS collaboration agreement consisted of three performance obligations, (i) technology (license and target selections), know-how and manufacturing in the field of gene therapy and development and active contribution to the development through the joint steering committee participations, (ii) provision of employees, goods and services for research, and (iii) clinical and commercial manufacturing.

The Company determined that these three performance obligations are substantially identical with the performance obligations in accordance with its new revenue recognition policies:

(i) Providing access to its technology and know-how in the field of gene therapy as well as actively contributing to the target selection, the collaboration as a whole, the development during the target selection, the pre-clinical and the clinical phase through participating in joint steering committee and other governing bodies (“License Revenue”);

(ii) Providing pre-clinical research activities (“Collaboration Revenue”);

(iii) Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”).

License Revenue

The Company previously recognized License Revenue over the expected performance period on a straight-line basis commencing on May 21, 2015.

The Company now recognizes License Revenue over the expected performance period based on its progress toward the completion of its services (see note 3 for a detailed discussion).

Collaboration and Manufacturing Revenue

The adoption of the new revenue recognition policies did not materially impact the recognition of Collaboration or Manufacturing Revenue.

ASC 825 Recognition and Measurement of Financial Assets and Financial Liabilities

In January 2016, the FASB issued ASU 2016-01, Financial Instruments—Overall (Subtopic 825-10):

Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”).

ASU 2016-01 addresses certain aspects of recognition, measurement, presentation and disclosure of financial instruments.

ASU 2016-01 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, which for the Company was January 1, 2018.

ASU 2016-01 did not have a material impact on the Company’s consolidated financial statements.

Derivatives and Hedging:

Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships

In March 2016, the FASB issued ASU 2016-05, Derivatives and Hedging:

Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships (“ASU 2016-05”) and ASU 2016-06, Derivatives and Hedging:

Contingent Put and Call Options in Debt Instruments.

Both ASUs address issues regarding hedge accounting.

The ASUs are effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, which for the Company was January 1, 2018.

Neither ASU 2016-05 nor ASU 2016-06 had a material impact on the Company’s consolidated financial statements.

Compensation (topic 718)- scope of modification accounting

In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (topic 718)- Scope of Modification Accounting (“ASU 2017-09”), which provides clarity regarding the applicability of modification accounting in relation to share-based payment awards.

Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions.

The effective date for the standard is for fiscal years beginning after December 15, 2017, which for the Company was January 1, 2018.

The new standard was to be applied prospectively.

ASU 2017-09 did not have a material impact on the Company’s consolidated financial statements.

Codification Updates to SEC Sections

In July 2019, the FASB issued ASU 2019-07, Codification Updates to SEC Sections (“ASU 2019-07”), which provides amendments to SEC Paragraphs Pursuant to SEC Final Rule Releases No.

33-10532, Disclosure Update and Simplification, and Nos.

33-10231 and 33-10442, Investment Company Reporting Modernization, and Miscellaneous Updates.

The effective date for the standard is upon issuance.

ASU 2017-09 did not have a material impact on the Company’s consolidated financial statements.

Recent Accounting Pronouncements Not Yet Effective

Fair Value Measurement

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) which modifies the disclosure requirements on fair value measurements.

The effective date for the standard is fiscal years beginning after December 15, 2019, which for the Company is January 1, 2020.

Early adoption is permitted.

ASU 2018-13 is effective for fiscal years beginning after December 15, 2019, which for the Company was January 1, 2020.

The new disclosure requirements for changes in unrealized gains and losses in other comprehensive income for recurring Level 3 measurements, the range and weighted average of significant unobservable inputs and the amended requirements for the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption.

All other amendments should be applied retrospectively.

The Company does not expect ASU 2018-13 to have a material impact on its consolidated financial statements except for the inclusion of potentially additional disclosures for Level 3 inputs.

ASU 2018-13 did not have a material impact on the Company’s consolidated financial statements.

Recent Accounting Pronouncements Not Yet Effective

Collaboration arrangements and concentration of credit risk

In the years ended December 31, 2019, and December 31, 2018, the Company generated all collaboration and license revenues from its collaboration and license agreement with BMS.

The Company and Chiesi Farmaceutici S.p.A.

(“Chiesi”) terminated their collaboration in 2017.

As a result, the Company is not required to provide any further services to Chiesi.

Since June 2015, BMS has been considered a related party due to the combination of its equity investment in the Company (December 31, 2019:

2.4 million ordinary shares or 5.5 % of outstanding ordinary shares), the warrants as well as the obligations arising from the collaboration and license agreement the Company and BMS entered into in May 2015.

Services to the Company’s collaboration partners are rendered by the Dutch operating entity.

Total collaboration and license revenue generated from these partners are as follows:

Years ended December 31,

(in thousands)

Bristol Myers Squibb

Chiesi Farmaceutici S.p.A (terminated in 2017)

Amounts owed by BMS in relation to the collaboration services are as follows:

(in thousands)

Bristol Myers Squibb

BMS collaboration

In May 2015, the Company entered into a collaboration and license agreement (the “BMS CLA”) and various related agreements with BMS that provide BMS with exclusive access to the Company’s gene therapy technology platform for the research, development and commercialization of therapeutics aimed at multiple targets in cardiovascular and other diseases (“Collaboration Targets”).

CSL Behring collaboration

On June 24, 2020, uniQure biopharma B.V., a wholly-owned subsidiary of uniQure N.V., entered into the CSL Behring Agreement with CSL Behring LLC, (“CSL Behring”), pursuant to which CSL Behring will receive exclusive global rights to etranacogene dezaparvovec, the Company’s investigational gene therapy for patients with hemophilia B, (the “Product”).

Under the terms of the CSL Behring Agreement, the Company will receive a $ 450.0 million upfront cash payment upon the closing of the CSL Behring Agreement and be eligible to receive up to $ 1.6 billion in additional payments based on regulatory and commercial milestones.

The CSL Behring Agreement also provides that the Company will be eligible to receive tiered double-digit royalties in a range of up to a low-twenties percent of net sales of the Product based on sales thresholds.

Pursuant to the CSL Behring Agreement, the Company will be responsible for the completion of the HOPE-B clinical trial, manufacturing process validation, and the manufacturing supply of the Product until such time that these capabilities may be transferred to CSL Behring or its designated contract manufacturing organization.

Concurrently with the execution of the CSL Behring Agreement, 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.

Clinical development and regulatory activities performed by the Company pursuant to the CSL Behring Agreement will be reimbursed by CSL Behring.

CSL Behring will be responsible for global regulatory submissions and commercialization requirements for the Product.

The effectiveness of the transactions contemplated by the CSL Behring Agreement is contingent on completion of review under antitrust laws in the United States, Australia, and the United Kingdom, and certain provisions of the CSL Behring Agreement will not become effective until after we receive all such regulatory approvals.

As of December 31, 2020, such regulatory approvals had not been received in all jurisdictions.

As of December 31, 2020, the Company concluded it has no enforceable right to the upfront payment, the regulatory and sale milestone payments, or the royalties (together “CSL Behring License Revenue”) that the Company may receive in accordance with the CSL Behring Agreement, as all payments are contingent upon the successful completion of reviews under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Therefore, the Company determined it will not recognize any revenue in relation to the CSL Behring License Revenue, in accordance with ASC 606 during the year ended December 31, 2020.

In accordance with its existing license and other agreements, the Company is contractually required to pay in total a low to high single digit percentage of any upfront payment to its licensors and financial advisor (“License Fees”).

The Company did not record any License Fees in the year ended December 31, 2020, as the Company had not recognized the upfront payment as this date.

The Company incurred $ 2.1 million of expenses related to the obligations related to the CSL Behring Agreement that had not been satisfied as of December 31, 2020.

The Company capitalized these expenses as contract fulfillment costs (presented within Other current assets).

As of December 31, 2020, the Company also recognized a $ 2.1 million receivable (presented within Accounts receivable) from CSL Behring for expenses for which it has a right of reimbursement as well as a contract liability (presented within Accrued expenses and other current liabilities) for the same amount.

In accordance with ASC 606 it cannot recognize any CSL Behring License Revenue as of this date.

Bristol-Myers Squibb collaboration

2015 Agreement

In May 2015, the Company entered into the BMS CLA and various related agreements with BMS, which the Company collectively refers to as the BMS CLA, which provided BMS with exclusive access to the Company’s gene therapy technology platform for the research, development and commercialization of therapeutics aimed at multiple Collaboration Targets.

The initial four-year research term under the collaboration terminated on May 21, 2019.

During the initial research term of the BMS CLA, the Company supported BMS in discovery, non-clinical, analytical and process development efforts in respect of the Collaboration Targets.

For any Collaboration Targets that may be advanced, the Company will be responsible for manufacturing of clinical and commercial supplies using the Company’s vector technologies and industrial, proprietary insect-cell based manufacturing platform.

BMS reimburse the Company for all its research and development costs in support of the collaboration during the initial research term, and will lead development, regulatory and commercial activities for any Collaboration Targets that may be advanced.

The BMS CLA provides that the companies may collaborate on up to ten Collaboration Targets in total.

The Company has agreed to certain restrictions on its ability to work independently of the collaboration, either directly or indirectly through any affiliate or third party, on certain programs that would be competitive with the collaboration programs.

For any Collaboration Targets that may be advanced, the Company will be responsible for manufacturing of clinical and commercial supplies.

BMS reimbursed the Company for all its research and development costs in support of the collaboration, and will lead development, regulatory and commercial activities for any Collaboration Targets that may be advanced.

The BMS CLA initially provided that the Company and BMS could potentially have collaborated on up to ten Collaboration Targets in total.

BMS initially designated four Collaboration Targets, including S100A1 for congestive heart failure (“AMT-126”).

In October 2018, the Company and BMS completed a heart function proof-of-concept study of AMT-126 in a pre-clinical, diseased animal model.

The study demonstrated deoxyribonucleic acid delivery and expression of S100A1 in the myocardium, thereby validating the Company’s vector delivery platform in the animal model.

The data did not show a benefit on heart function at six months and, consequently, the Joint Steering Committee for the collaboration decided to discontinue work on S100A1.

The data did not show a benefit on heart function at six months and, consequently, work on S100A1 was discontinued.

The Company impaired a $ 5.4 million acquired research and development asset associated with the program and released a contingent liability of $ 3.8 million related to the acquisition of the asset to income in the year ended December 31, 2018.

In April 2019, BMS designated a new cardiovascular Collaboration Target to replace S100A1.

As a result, BMS has designated a total of four Collaboration Targets as of December 31, 2019.

The initial four-year research term under the collaboration terminated on May 21, 2019.

In February 2019, BMS requested a one-year extension of the research term.

In April 2019, following an assessment of the progress of this collaboration and the Company’s expanding proprietary programs, the Company notified BMS that the Company did not intend to agree to an extension of the research term but rather preferred to restructure or amend the collaboration to reduce or eliminate certain of the Company’s obligations under it.

Accordingly, the Company is currently in discussions with BMS potentially to restructure or amend the BMS CLA and other related agreements.

It is currently uncertain whether a change to the BMS CLA will be agreed and, if agreed, what the specific terms of any such change may be.

As a consequence, the Company has not taken into account the impact of such change, if any, on the timing of recognition of the prepaid License Revenue if and when the BMS CLA and other related agreements have been restructured or amended.

The final resolution of these discussion may or may not result in material changes to the Company’s collaboration with BMS.

The Company evaluated the BMS CLA and determined that its performance obligations in accordance with its adoption of ASC 606 on January 1, 2018, are as follows:

(ii) Providing pre-clinical Collaboration Target specific, non-clinical, analytical and process development services during the initial research term, which ended on May 21, 2019 (“Collaboration Revenue”);

(iii) Providing clinical and commercial manufacturing services for Collaboration Targets (“Manufacturing Revenue”).

To date the Company has not generated any Manufacturing Revenue.

During the aforementioned discussions with BMS potentially to restructure or amend the BMS CLA and other related agreements, which may be terminated by the Company or BMS at any time, the Company agreed, subject to certain conditions, to continue providing support of the pre-clinical Collaboration Targets, and any related costs will be reimbursed by BMS.

License Revenue – BMS

The Company recognized $ 5.0 million of License Revenue for the year ended December 31, 2019 (December 31, 2018:

$ 7.5 million, December 31, 2017:

$ 4.1 million) in relation to a $ 60.1 million upfront payment recorded on May 21, 2015, as well as $ 15.0 million received in relation to the designation of the second, third and fourth Collaboration Targets in August 2015 (together “Consideration”).

The Company would be entitled to an aggregate $ 16.5 million in target designation payments upon the selection of the fifth through tenth Collaboration Targets.

The Company would also be eligible to receive research, development and regulatory milestone payments of up to $ 254.0 million for a lead Collaboration Target and up to $ 217.0 million for each of the other selected Collaboration Targets, if defined milestones are achieved.

The Company would include the variable consideration related to the selection of the fifth to tenth Collaboration Target, or any of the milestones, in the transaction price once it is considered probable that including these payments in the transaction price would not result in the reversal of cumulative revenue recognized.

The Company would recognize significant amounts of License Revenue for services performed in prior periods if and when the Company considers this probable.

Due to the significant uncertainty surrounding the development of gene-therapy product candidates and the dependence on BMS’s performance and decisions, the Company does not currently consider this probable.

Additionally, the Company is eligible to receive net sales-based milestone payments and tiered mid-single to low double-digit royalties on product sales.

The royalty term is determined on a licensed-product-by-licensed-product and country-by-country basis and begins on the first commercial sale of a licensed product in a country and ends on the expiration of the last to expire of specified patents or regulatory exclusivity covering such licensed product in such country or, with a customary royalty reduction, ten years after the first commercial sale if there is no such exclusivity.

These revenues will be recognized when performance obligations are satisfied.

Under the previous revenue standard, the Company recognized License Revenue over the expected performance period on a straight-line basis commencing on May 21, 2015.

In accordance with the new revenue recognition standards, the Company recognizes License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services.

The Company determines such progress by comparing activities performed at the end of each reporting period with total activities expected to be performed.

The Company estimates total expected activities using a number of unobservable inputs, such as the probability of BMS designating additional targets, the probability of successfully completing each phase and estimated time required to provide services during the various development stages.

If available, the Company uses product candidate-specific research and development plans.

Alternatively, the Company assumes that completion of the pre-clinical phase requires an average of four years and that clinical development and commercial launch on average require 8.5 years.

The estimation of total services at the end of each reporting period involves considerable judgement.

The estimated number of Collaboration Targets that BMS will pursue significantly impacts the amount of License Revenue the Company recognizes.

For example, if the Company would increase the probability of all additional Collaboration Targets being designated by 10 % then the revenue for the annual period ended December 31, 2019 would have decreased by approximately $ 1.9 million, as the Company would be required to render more services in relation to the Consideration received.

Collaboration Revenue – BMS

The Company recognizes Collaboration Revenues associated with pre-clinical Collaboration Target specific, non-clinical, analytical and process development activities that are reimbursable by BMS under its collaboration agreement during the initial research term (that ended on May 21, 2019).

The Company is currently in discussions with BMS potentially to restructure or amend the collaboration and license agreement and other related agreements following the expiration of the research term.

During these discussions, which may be terminated by the Company or BMS at any time, the Company has agreed to continue providing support of the pre-clinical Collaboration Targets, and any related costs will be reimbursed by BMS.

The Company has provided target-specific research and development services to BMS, and, subject to the outcome of the discussions with BMS, may continue to do so.

As a result, BMS had designated a total of four Collaboration Targets as of December 31, 2019.

2020 Amendment

In February 2019, BMS requested a one-year extension of the initial research term.

In April 2019, following an assessment of the progress of the collaboration and the Company’s expanding proprietary programs, the Company notified BMS that the Company did not intend to agree to an extension of the initial research term but rather preferred to restructure or amend the collaboration to reduce or eliminate certain of the Company’s obligations under it.

On December 1, 2020, the Company and BMS entered into the amended BMS CLA.

Under the amended BMS CLA, BMS is limited to four Collaboration Targets.

For a period of one-year from the effective date of the amended BMS CLA, BMS may replace up to two of these four Collaboration Targets with up to two new targets in the field of cardiovascular disease.

The Company continues to be eligible to receive research, development, and regulatory milestone payments of up to $ 217.0 million for each Collaboration Target, if defined milestones are achieved.

BMS is no longer entitled to designate the fifth to tenth Collaboration Targets and as such the Company’s remaining obligations under the amended BMS CLA are substantially reduced.

The Company is no longer entitled to receive up to an aggregate $ 16.5 million in target designation payments for the research, development and regulatory milestone payments associated with the fifth to tenth Collaboration Targets.

For as long as any of the four Collaboration Targets are being advanced, BMS may place a purchase order to be supplied with research, clinical and commercial supplies.

Subject to the terms of the amended BMS CLA, BMS has the right to terminate the research, clinical and commercial supply relationships, and has certain remedies for failures of supply, up to and including technology transfer for any such failure that otherwise cannot be reasonably resolved.

Both BMS and the Company may agree to a technology transfer of manufacturing capabilities pursuant to the terms of the amended BMS CLA.

The amended BMS CLA does not extend the initial research term.

BMS may place purchase orders to provide limited services primarily related to analytical and development efforts in respect of the four Collaboration Targets.

BMS may request such services for a period not to exceed the earlier of (i) the completion of all activities under a Research Plan and (ii) either (A) three years after the last replacement target has been designated by BMS during the one year replacement period following the amended BMS CLA effective date or (B) three years if no replacement targets are designated during this one year period and BMS continues to reimburse the Company for these services.

The Company evaluated the impact of the amendment of the BMS CLA in relation to its performance obligation related to:

– Providing access to its technology and know-how in the field of gene therapy and participating in joint steering committee and other governing bodies (materially satisfied as of December 1, 2020) (“License Revenue”).

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.

The Company evaluated the effect the modification has on its measure of progress towards the completion of its performance obligation related to License Revenue and recorded an adjustment to License Revenue as of December 1, 2020.

Services to BMS are rendered by the Dutch operating entity.

Total collaboration and license revenue generated with BMS are as follows (presented as revenue from a related party until November 30, 2020, and as revenue from December 1, 2020 onwards):

Years ended December 31,

(in thousands)

Bristol Myers Squibb

Amounts owed by BMS in relation to the Collaboration and License Revenue are as follows (presented as “Accounts receivables” as of December 31, 2020 and as “Accounts receivable from related party” as of December 31, 2019):

(in thousands)

Bristol Myers Squibb

Collaboration Revenue

The Company recognizes collaboration revenues associated with Collaboration Target-specific pre-clinical analytical development and process development activities that are reimbursable by BMS under the BMS CLA and the amended BMS CLA as well as other related agreements.

Collaboration Revenue related to these contracted services is recognized when performance obligations are satisfied.

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$ 3.8 million).

Manufacturing Revenue – BMS

BMS and the Company also entered into a Master Clinical Supply Agreement in April 2017 for the Company to supply gene therapy products during the clinical phase as well as into a binding term sheet to supply gene therapy products during the commercial phase to BMS.

Revenues from product sales will be recognized when earned.

To date the Company has not supplied any clinical and commercial gene therapy product to BMS.

Chiesi collaboration

In 2013, the Company entered into two agreements with Chiesi, one for the co-development and commercialization of the hemophilia B program (the “Hemophilia Collaboration Agreement”) and one for the commercialization of Glybera (the “Glybera Agreement”, and together with the Collaboration Agreement, the “Chiesi Agreements”) in Europe and selected territories.

In April 2017, the parties agreed to terminate the Glybera Agreement.

As of October 2017, the Company is not required to supply Glybera to Chiesi.

In July 2017, the parties terminated the Hemophilia Collaboration Agreement and the Company reacquired rights associated with its hemophilia B program in Europe and selected territories.

License Revenue – Chiesi

Upon the closing of the Chiesi Agreements on June 30, 2013, the Company received € 17.0 million ($ 22.1 million) in non-refundable up-front payments.

The Company determined that the up-front payments constituted a single unit of accounting that should be amortized as License Revenue on a straight-line basis over the performance period of July 2013 through September 2032.

In July 2017, the Company fully released the outstanding deferred revenue and recorded $ 13.8 million other income during the year ended December 31, 2017.

The Company recognized no License Revenue for the year ended December 31, 2019 (December 31, 2018:

December 31, 2017:

License Revenue

The Company recognized $ 33.0 million of License Revenue for the year ended December 31, 2020 (December 31, 2019:

$ 5.0 million, December 31, 2018:

$ 7.5 million).

The Company recognized the License Revenue for the year ended December 31, 2017, net of a $ 0.5 million reduction for amounts previously amortized and repaid by the Company in accordance with the Glybera Termination Agreement in 2017.

Collaboration Revenue – Chiesi

Prior to the termination of the Hemophilia Collaboration Agreement up to June 30, 2017, Chiesi reimbursed the Company for 50 % of the agreed research and development efforts related to hemophilia B.

These reimbursable amounts have been presented as Collaboration Revenue.

The Company generated no Collaboration Revenue for the year ended December 31, 2019 (December 31, 2018:

December 31, 2017:

$ 4.6 million) from the co-development of hemophilia B.

On May 21, 2015, the Company recorded a $ 60.1 million upfront payment and in August 2015 it recorded a $ 15.0 million payment it received from BMS in relation to the designation of the second, third and fourth Collaboration Targets.

The Company recognizes License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services.

The Company determines such progress by comparing activities performed at the end of each reporting period with total activities expected to be performed.

The Company estimates total expected activities using several unobservable inputs, such as the probability of BMS designating additional targets, the probability of successfully completing each phase and estimated time required to provide services during the various development stages.

The estimation of total services at the end of each reporting period involves considerable judgement.

The amount of services the Company expects to provide is significantly impacted by the number of Collaboration Targets that it estimates BMS would pursue.

As a result of the December 1, 2020 amendment of the BMS CLA the Company no longer is required to potentially provide any services in relation to six additional targets that BMS might have designated.

The Company determined its remaining performance obligation is immaterial.

The Company adjusted its measure of progress towards the completion of its activities related to its services as of the December 1, 2020 modification date accordingly.

The Company 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.

The Company includes variable consideration related to any research, development, and regulatory milestone payments, in the transaction price once it is considered probable that including these payments in the transaction price would not result in the reversal of cumulative revenue recognized.

On December 17, 2020 BMS designated one of the four Collaboration Targets as a candidate to advance into IND-enabling studies entitling the Company to receive a $ 4.4 million research milestone payment.

The Company recorded the $ 4.4 million as License Revenue in the twelve-month period ended December 31, 2020.

The Company recognizes License Revenue related to product sales by BMS from any of the Collaboration Targets when the sales occur.

The Company is eligible to receive net sales-based milestone payments and tiered mid-single to low double-digit royalties on product sales.

Fair value measurement

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The Company’s only material financial assets measured at fair value using Level 1 inputs is cash and cash equivalents.

Liabilities measured at fair value using Level 3 as of December 31, 2019 inputs consisted of derivative financial instruments.

The liability measured at fair value using Level 3 inputs as of December 31, 2020 was the derivative financial instrument.

The Company had recorded derivative financial instruments as of December 31, 2019, that were measured at fair value using Level 3 inputs.

Changes in Level 3 items during the years ended December 31, 2020, 2019 and 2018 are as follows:

2 unchanged sentences

Balance at December 31, 2017

Exercises of convertible loan warrants

Net losses recognized in profit or loss

Contingent consideration paid

Currency translation effects

Balance at December 31, 2017

Net gains recognized in profit or loss

2 unchanged sentences

Net losses recognized in profit or loss

Exercise of warrants

Exercise of Hercules warrants

Currency translation effects

Balance at December 31, 2019

Net gains recognized in profit or loss

Derecognition of warrants

Recognition of derivative financial liability of CoC-payment

Currency translation effects

Balance at December 31, 2020

Derivative financial instruments

The Company issued derivative financial instruments related to its collaboration with BMS and in relation to the issuance of the Hercules Technology Growth Corp.

(“Hercules”) loan facility.

Pursuant to the BMS CLA, the Company granted BMS two warrants:

● A warrant allowing BMS to purchase a specific number of uniQure ordinary shares such that its ownership will equal 14.9 % immediately after such purchase.

The warrant can be exercised on the later of (i) the date on which the Company receives from BMS the Target Designation Fees (as defined in the BMS CLA) associated with the first six new targets (a total of seven Collaboration Targets);

and (ii) the date on which BMS designates the sixth new target (the seventh Collaboration Target);

● A warrant allowing BMS to purchase a specific number of uniQure ordinary shares such that its ownership will equal 19.9 % immediately after such purchase.

The warrant can be exercised on the later of (i) the date on which the Company receives from BMS the Target Designation Fees associated with the first nine new targets (a total of ten Collaboration Targets);

and (ii) the date on which BMS designates the ninth new target (the tenth Collaboration Target).

As of December 31, 2019, BMS had designated a total of four Collaboration Targets, and as such, the warrants were not exercisable.

Pursuant to the terms of the BMS CLA the exercise price in respect of each warrant is equal to the greater of (i) the product of (A) $ 33.84 , multiplied by (B) a compounded annual growth rate of 10 % (or approximately $ 52.39 as of December 31, 2019) and (ii) the product of (A) 1.10 multiplied by (B) the VWAP for the 20 trading days ending on the date that is five trading days prior to the date of a notice of exercise delivered by BMS.

The fair value of the warrants as of December 31, 2019 is $ 3.1 million (December 31, 2018:

$ 0.8 million).

During the year ended December 31, 2019, the Company recognized a $ 2.3 million loss in non-operating income / expense (December 31, 2018:

$ 0.5 million gain;

The Company issued derivative financial instruments related to its collaboration with BMS and in relation to the issuance of the Hercules loan facility.

Derivative financial instruments BMS

Pursuant to the BMS CLA, the Company in 2015 granted BMS two warrants that were subsequently terminated in connection with the amendment to the BMS CLA on December 1, 2020.

The Company granted to BMS:

● A warrant that allowed BMS to purchase a specific number of the Company’s ordinary shares such that its ownership would have equaled 14.9 % immediately after such purchase (“1 st warrant”).

The 1 st warrant could have been exercised on the later of (i) the date on which the Company received from BMS the Target Designation Fees (as defined in the BMS CLA) associated with the first six new targets (a total of seven Collaboration Targets);

and (ii) the date on which BMS designated the sixth new target (the seventh Collaboration Target);

● A warrant that allowed BMS to purchase a specific number of the Company’s ordinary shares such that its ownership would have equaled 19.9 % immediately after such purchase (“2 nd warrant” and together with 1 st warrant, the “warrants”).

The warrant could have been exercised on the later of (i) the date on which the Company received from BMS the Target Designation Fees associated with the first nine new targets (a total of ten Collaboration Targets);

and (ii) the date on which BMS designated the ninth new target (the tenth Collaboration Target).

On December 1, 2020, the Company derecognized the warrants when these were terminated in accordance with the amended BMS CLA.

Pursuant to the terms of the BMS CLA the exercise price in respect of each warrant was equal to the greater of (i) the product of (A) $ 33.84 , multiplied by (B) a compounded annual growth rate of 10 % (or approximately $ 57.32 as of November 30, 2020) and (ii) the product of (A) 1.10 multiplied by (B) the weighted average volume price (“VWAP”) for the 20 trading days ending on the date that is five trading days prior to the date of a notice of exercise delivered by BMS.

The fair value of the warrants as of December 31, 2019 was $ 3.1 million.

During the year ended December 31, 2020, the Company recognized a $ 3.1 million gain in non-operating income / expense (December 31, 2019:

$ 2.3 million loss;

December 31, 2018:

$ 1.2 million loss) related to fair value changes of the BMS warrants.

As of December 31, 2019, BMS had designated a total of four Collaboration Targets, and as such, the warrants were not exercisable.

The Company estimated the exercise of the warrants to occur within two and four years after the balance sheet date.

The Company classified the derivative financial liabilities as non-current at the balance sheet date.

$ 0.5 million gain) related to fair value changes of the BMS warrants.

The gain recognized in the year ended December 31, 2020 includes $ 0.8 million from the derecognition of the BMS warrants on December 1, 2020.

The Company used Monte-Carlo simulations to determine the fair market value of the BMS warrants.

The valuation model incorporates several inputs, the risk-free rate adjusted for the period affected, an expected volatility based on historical Company volatility, the expected yield on any dividends and management’s expectations on the timelines of reaching certain defined trigger events for the exercising of the warrants, as well as management’s expectations regarding the number of ordinary shares that would be issued upon exercise of the warrants.

The valuation model incorporated several inputs, the risk-free rate adjusted for the period affected, an expected volatility based on historical Company volatility, the expected yield on any dividends and management’s expectations on the timelines of reaching certain defined trigger events for the exercising of the warrants, as well as management’s expectations regarding the number of ordinary shares that would be issued upon exercise of the warrants.

All of these represent Level 3 inputs.

Additionally, the model assumes BMS will exercise the warrants only if it is financially rational to do so.

The Company conducted a sensitivity analysis to assess the impact on changes in assumptions on the fair value.

Specifically, the Company examined the impact on the fair market value of the warrants by increasing the volatility by 10 % to 82.5 %.

A further sensitivity analysis was performed assuming the warrants would be exercised a year later than currently estimated.

The table below illustrates the impact on the fair market valuation associated with these changes in assumptions as of December 31, 2019.

Total warrants

Increase volatility by 10 % to 82.5 %

Extend exercise dates by one year

Additionally, the model assumed BMS would exercise the warrants only if it was financially rational to do so.

The warrants could only have been exercised following the occurrence of events contractually defined in the warrant agreements.

The probability of the occurrence of these events represented another significant unobservable input used in the calculation of the fair value of the warrants.

On December 1, 2020, the Company and BMS terminated the BMS warrants and 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, uniQure (or its third party acquirer) shall pay to BMS a one-time, non-refundable, non-creditable cash payment of $ 70.0 million, provided that (x) if $ 70.0 million is greater than five percent ( 5.0 %) of the net proceeds (as contractually defined) from such change of control transaction, the payment shall be an amount equal to five percent of such net proceeds, and (y) if $ 70.0 million is less than one percent of such net proceeds, the change of control payment shall be an amount equal to one percent of such net proceeds (“CoC-payment”).

The Company has not consummated any change of control transaction as of December 31, 2020 that would obligate it to make a CoC-payment.

The Company determined that the CoC-payment should be recorded as a derivative financial liability as of December 1, 2020 and that subsequent changes in the fair market value of this derivative financial liability should be recorded in profit and loss.

The fair market value of the derivative financial liability is materially impacted by probability that market participants assign to the likelihood of the occurrence of a change of control transaction that would give rise to a CoC-payment.

This probability represents an unobservable input.

The Company determined the fair market value of the derivative financial liability by using a present value model based on expected cash flow.

The expected cash flows are materially impacted by the probability that market participants assign to the likelihood of the occurrence of a change of control event within the biotechnology industry.

The Company estimated this unobservable input using the best information available as of December 1, 2020 and December 31, 2020.

The Company obtained reasonably available market information that it believed market participants would use in determining the likelihood of the occurrence of a change-of control transaction within the biotechnology industry.

Selecting and evaluating market information involves considerable judgement and uncertainty.

Based on all such information and its judgment the Company estimated that the fair market value of the derivative financial liability (presented within “Other non-current liabilities”) as of December 1, 2020 and December 31, 2020 was $ 2.6 million.

The Company recorded a $ 2.6 million loss within “Other non-operating expenses” in the twelve-month period ended December 31, 2020 related to the initial recognition of this derivative financial liability.

Hercules loan facility

4 unchanged sentences

The Company issued 37,175 ordinary shares at $ 34.25 following the exercise of all Hercules warrants and receipt of $ 0.5 million from Hercules.

As a result, the fair value of this derivative, recorded in other current liabilities, as of December 31, 2019 is nil (December 31, 2018:

$ 0.6 million).

During the year ended December 31, 2019, the Company recognized a $ 0.2 million loss in other non-operating income / (expense) (December 31, 2018:

During the year ended December 31, 2020, the Company recognized no more gains or losses in other non-operating income / (expense) (December 31, 2019:

$ 0.2 million loss;

3 unchanged sentences

In connection with the Company’s acquisition of the InoCard business (“InoCard”) in 2014, the Company recorded contingent consideration related to amounts potentially payable to InoCard’s former shareholders.

The amounts payable in accordance with the sale and purchase agreement (as amended in August 2017) are contingent upon realization of milestones associated with its S100A1 protein research program.

The amounts payable in accordance with the sale and purchase agreement (as amended in August 2017) were contingent upon realization of milestones associated with its S100A1 protein research program.

Following the discontinuation of the research program the Company since 2018 no longer expects to realize those milestones and recorded a $ 3.8 million gain within research and development expenses for the year ended December 31, 2018, to release the liability to profit and loss.

Accordingly, the fair value of the contingent liability as of December 31, 2019 amounted to nil (December 31, 2018:

The Company made $ 1.2 million in milestone payments related to the liability during the year ended December 31, 2017, 50 % of which were settled through the issuance of 64,648 restricted ordinary shares on October 2, 2017.

In addition, in 2017, the parties modified the conditions of the agreed milestone payments, including a reduction of the percentage of any future milestone that can be settled in the form of Company ordinary shares from 100 % to 50 %.

The Company recorded $ 2.3 million expenses in research and development cost in the year ended December 31, 2017, related to the increase in fair value of the contingent consideration resulting from these modifications.

Property, plant, and equipment, net

The following table presents the Company’s property, plant, and equipment as of December 31:

(in thousands)

Leasehold improvements

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$ 6.5 million).

Depreciation expense is allocated to research and development expenses to the extent it relates to the Company’s manufacturing facility and equipment.

Depreciation expense is allocated to research and development expenses to the extent it relates to the Company’s manufacturing facility and equipment and laboratory equipment.

All other depreciation expenses are allocated to selling, general and administrative expense.

The following table summarizes property, plant, and equipment by geographic region.

(in thousands)

Lexington, Massachusetts (United States of America)

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Amsterdam / The Netherlands

In March 2016, the Company entered into a 16-year lease for a facility in Amsterdam, the Netherlands and

amended this agreement in June 2016.

In March 2016, the Company entered into a 16-year lease for a facility in Amsterdam, the Netherlands and amended this agreement in June 2016.

The Company consolidated its three Amsterdam sites into the new site at the end of May 2017.

2 unchanged sentences

On December 1, 2017, the Company entered into an agreement to sub-lease three of the seven floors of its Amsterdam facility for a ten-year term ending on December 31, 2027, with an option for the sub-lessee to extend until December 31, 2031.

The fixed lease payments to be received during the remaining eight-year term amount to $ 8.9 million (EUR 7.9 million) as of December 31, 2019.

In February 2020, the Company amended the agreement to sub-lease to take back one of the three floors effective March 1, 2020.

The fixed lease payments to be received during the remaining term under the agreement to sub-lease amount to $ 6.6 million (EUR 5.4 million) as of December 31, 2020.

Operating lease liabilities

As no implicit rate in relation to the three above facility leases and other equipment leases was readily available, the Company used an incremental borrowing rate to discount the lease payments.

The Company derived the discount rates, adjusted for differences such as in the term and payment patterns, from the Company’s loan from Hercules Capital, which was refinanced in December 2018.

The components of lease cost in accordance with the new lease accounting standard were as follows:

December 31, 2019

Year ended December 31,

(in thousands)

3 unchanged sentences

Total lease cost

The rent expense in accordance with the historical lease accounting standard for the years ended December 31, 2018, and December 31, 2017 was calculated on a straight-line basis over the term of the lease and considers $ 12.2 million of lease incentives received.

The rent expense in accordance with the historical lease accounting standard for the year ended December 31, 2018, was calculated on a straight-line basis over the term of the lease and considered $ 12.2 million of lease incentives received.

Aggregate rent expense was as follows:

Year ended December 31,

(in thousands)

Rent expense - Lexington

Rent expense - Amsterdam

Total rent expense

The table below presents the lease-related assets and liabilities recorded on the Consolidate balance sheet in accordance with the new lease accounting standard.

December 31, 2019

Total lease cost

The table below presents the lease-related assets and liabilities recorded on the Consolidate balance sheets in accordance with the new lease accounting standard.

(in thousands)

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Other information

The weighted-average remaining lease term as of December 31, 2019 is 10.3 years and the weighted-average discount rate as of this date is 11.33 % .

The weighted-average remaining lease term as of December 31, 2020, is 9.4 years, compared to 10.3 years as of December 31, 2019, and the weighted-average discount rate as of December 31, 2020, is 11.37 % , compared to 11.33 % as of December 31, 2019.

The Company derived the weighted-average discount rate, adjusted for differences such as in the term and payment patterns, from the Company’s loan from Hercules capital which was refinanced immediately prior to the January 1, 2019, adoption date in December 2018.

The table below presents supplemental cash flow and non-cash information related to leases required in accordance with the new lease accounting standard.

December 31, 2019

Year ended December 31,

(in thousands)

Cash paid for amounts included in the measurement of lease liabilities

Operating cash flows for operating leases (1)

Right-of-use asset obtained in exchange for lease obligation

Operating lease 2)

( 1) The Company has received $ 1.5 million of landlord incentive payments as of December 31, 2019, which are not included in the cash paid amounts.)

( 2) The Company capitalized $ 19.0 million of operating right-of-use assets upon adoption of the new lease standard on January 1, 2019 that are not included in the movement for the year ended December 31, 2019.)

(1) The Company has received $ 1.5 million of landlord incentive payments for the year ended December 31, 2019, which are not included in the cash paid amounts.)

The Company did not obtain any right-of-use assets in exchange for the lease obligations during the year ended December 31, 2020.

Besides the initial recognition of operating right-of-use assets of $ 19.0 million upon adoption of the new lease standards on January 1, 2019, the Company obtained $ 9.0 million of additional right-of-use assets in exchange for lease obligations during the year ended December 31, 2019.

Undiscounted cash flows

The table below reconciles the undiscounted cash flows as of December 31, 2020, for each of the first five years and the total of the remaining years to the operating lease liabilities recorded on the Consolidated balance sheet as of December 31, 2020 in accordance with the new lease accounting standard.

Amsterdam (1)

(in thousands)

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(1) Payments are due in EUR and have been translated at the foreign exchange rate as of December 31, 2020, of $ 1.23 / €1.00)

As of December 31, 2018, aggregate minimum lease payments under the historical accounting standard ASC 840 (excluding payments from the sub-lease agreement) for the calendar years and lease incentives received were as follows:

(in thousands)

Total minimum lease payments

Intangible assets

6 unchanged sentences

The acquired licenses have a weighted average remaining life of 8.5 years as of December 31, 2020.

During the year ended December 31, 2020, the Company capitalized $ 2.2 million of expenditures related to costs incurred in relation to rights to exclusively evaluate certain technologies during a two-year period that commenced on February 1, 2020.

During the same period, the Company disposed of a number of licenses determined to have no alternative future use.

During the year ended December 31, 2019, the Company capitalized $ 1.0 million of expenditures related to contractual milestone payments under existing license agreements.

During the year ended December 31, 2018, the Company capitalized $ 1.9 million of expenditures related to contractual milestone payments under existing license agreements as well as costs incurred in relation to entering into new license agreements.

During the year ended December 31, 2018, the Company disposed a number of fully amortized, expired licenses .

As of December 31, 2020, the estimated future amortization expense for each of the five succeeding years and the period thereafter is as follows:

The carrying amount of the Company’s licenses by licensor is set out below.

Protein Sciences Corporation

Jude Children’s Hospital

(in thousands)

The amortization expense related to licenses for the year ended December 31, 2020 was $ 4.6 million (December 31, 2019:

2 unchanged sentences

$ 0.4 million).

Acquired research and development (“Acquired R&D”)

The impairment expense related to licenses for the year ended December 31, 2020 was $ 0.3 million (December 31, 2019:

$ 0.0 million;

December 31, 2018 $ 0.1 million).

Acquired research and development

The Company acquired research and development assets as part of its acquisition of InoCard in July 2014.

6 unchanged sentences

Personnel related accruals and liabilities

Derivative financial liability warrants (see note 4)

Contract liability (see Note 3.

Collaboration arrangements)

Long-term debt

On June 14, 2013, the Company entered into a venture debt loan facility with Hercules, which was amended and restated on June 26, 2014, and again on May 6, 2016 (“2016 Amended Facility”).

The 2016 Amended Facility extended the maturity date from June 30, 2018, to May 1, 2020.

As of December 31, 2017, and December 31, 2016, $ 20.0 million was outstanding.

The interest rate was adjustable and was the greater of (i) 8.25 % or (ii) 8.25 % plus the prime rate less 5.25 %.

Under the 2016 Amended Facility, the interest rate initially was 8.25 % per annum.

The interest-only payment period was extended by 12 months to November 30, 2018 as a result of raising more than $ 50.0 million in equity financing in October 2017.

On December 6, 2018, the Company signed an amendment to the Second Amended and Restated Loan and Security Agreement that both refinanced the existing $ 20 million 2016 Amended Facility and provided an additional commitment of $ 30 million (of which $ 15 million is subject to the discretion of Hercules) (the “2018 Amended Facility”).

At signing, the Company drew down an additional $ 15 million for a total of $ 35 million outstanding.

The Company has the right to draw another $ 15 million through June 30, 2020 subject to the terms of the 2018 Amended Facility.

The 2018 Amended Facility extends the loan’s maturity date from May 1, 2020 until June 1, 2023.

The interest-only period was initially extended from November 2018 to January 1, 2021.

The interest-only period was further extended to January 1, 2022 as a result of meeting the provision in the 2018 Amended Facility of raising more than $ 90.0 million in equity financing.

The Company met this provision as a result of the follow-on public offering completed in September 2019.

On December 6, 2018, the Company signed an amendment to the Second Amended and Restated Loan and Security Agreement that both refinanced the then-existing $ 20.0 million 2016 Amended Facility and provided an additional unconditional commitment of $ 15.0 million as well as a conditional commitment of $ 15.0 million that expired on June 30, 2020 (the “2018 Amended Facility”).

At signing of the 2018 Amended Facility, the Company drew down an additional $ 15.0 million for a total of $ 35.0 million outstanding.

The 2018 Amended Facility extended the loan’s maturity date from May 1, 2020 until June 1, 2023.

The interest-only period was initially extended from November 2018 to January 1, 2021, and was further extended to January 1, 2022, as a result of meeting the provision in the 2018 Amended Facility of raising more than $ 90.0 million in equity financing in September 2019.

The Company is required to repay the facility in equal monthly installments of principal and interest between the end of the interest-only period and the maturity date.

The interest rate continues to be adjustable and is the greater of (i) 8.85 % or (ii) 8.85 % plus the prime rate less 5.50 % per annum.

Under the 2018 Amended Facility, the Company paid a facility fee of 0.50 % of the $ 35 million outstanding as of signing and will owe a back-end fee of 4.95 % of the outstanding debt.

In addition, in May 2020 the Company owes a back-end fee of 4.85 % of $ 20 million, which is the amount of debt raised under the 2016 Amended Facility.

Under the 2018 Amended Facility, the Company paid a facility fee of 0.50 % of the $ 35.0 million outstanding as of signing and owes a back-end fee of 4.95 % of the outstanding debt.

In addition, in May 2020 the Company paid a back-end fee of $ 1.0 million in relation to the 2016 Amended Facility.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2018 Amended Facility was $ 35.9 million as of December 31, 2020, compared to $ 36.3 million as of December 31, 2019, and is recorded net of discount and debt issuance costs.

The foreign currency loss on the loan was $ 0.7 million in 2019 (2018:

The foreign currency gain on the loan was $ 3.1 million in 2020 (2019:

loss of $ 0.7 million;

gain of $ 2.6 million).

loss of $ 0.9 million).

The fair value of the loan approximates its carrying amount.

1 unchanged sentence

Interest expense recorded during the years ended December 31 was as follows:

As a covenant in the 2018 Amended Facility, the Company has periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the United States, equivalent to the lesser of 65 % of the outstanding balance of principal due or 100% of worldwide cash and cash equivalents.

This restriction on cash and cash equivalents only relates to the location of the cash and cash equivalents, and such cash and cash equivalents can be used

at the discretion of the Company.

(in millions)

As a covenant in the 2018 Amended Facility, the Company has periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the United States, equivalent to the lesser of (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.

In combination with other covenants, the 2018 Amended Facility restricts the Company’s ability to, among other things, incur future indebtedness and obtain additional debt financing, to make investments in securities or in other companies, to transfer assets, to perform certain corporate changes, to make loans to employees, officers, and directors, and to make dividend payments and other distributions.

The Company secured the facilities by pledging the shares in its subsidiaries, substantially all its receivables, moveable assets as well as the equipment, fixtures, inventory and cash of uniQure Inc.

The Company secured the facilities by directly or indirectly pledging its total assets of $ 340.4 million with the exception of $ 115.2 million of cash and cash equivalents and other current assets held by uniQure N.V.

The 2018 Amended Facility contains provisions that include the occurrence of a material adverse effect, as defined therein, which would entitle Hercules to declare all principal, interest and other amounts owed by the Company immediately due and payable.

As of December 31, 2020, the Company was in compliance with all covenants and provisions.

The aggregate maturities of the loan, including $ 11.5 million of coupon interest payments and financing fees, for each of the 41 months subsequent to December 31, 2019, are as follows:

The aggregate maturities of the loan, including $ 7.4 million of coupon interest payments and financing fees, for each of the 29 months after December 31, 2020, are as follows (prior to the January 2021 loan amendment – see Note 18, “Subsequent events”):

(in thousands)

Shareholders’ equity

As of December 31, 2019, the Company’s authorized share capital is € 3.0 million (exchange rate as of December 31, 2019, of $ 1.12 / €1.00;

$ 3.4 million), divided into 60,000,000 ordinary shares, each with a nominal value of € 0.05 .

As of December 31, 2020, the Company’s authorized share capital is € 3.0 million (or $ 3.7 million when translated at an exchange rate as of December 31, 2020, of $ 1.23 / €1.00), divided into 60,000,000 ordinary shares, each with a nominal value of € 0.05 .

Under Dutch law, the authorized share capital is the maximum capital that the Company may issue without amending its articles of association.

1 unchanged sentence

Besides the minimum amount of share capital to be held under Dutch law, there are no distribution restrictions applicable to the equity of the Company.

As of December 31, 2019, and 2018 and 2017 the Company’s reserves were restricted for payment of dividends for accumulated foreign currency translation losses of $ 6.7 million, $ 7.3 million and $ 3.8 million, respectively.

As of December 31, 2020, and 2019 and 2018 the Company’s reserves were restricted for payment of dividends for an accumulated foreign currency translation gain of $ 9.9 million in 2020 and accumulated foreign currency translation losses of $ 6.7 million and $ 7.3 million in 2019 and 2018, respectively.

On September 10, 2019, the Company completed a follow-on public offering of 4,891,305 ordinary shares at a public offering price of $ 46.00 per ordinary share, and on September 13, 2019, the Company completed the sale of an additional 733,695 ordinary shares at a public offering price of $ 46.00 per ordinary share pursuant to the exercise by the underwriters of the option to purchase additional ordinary shares, resulting in total gross proceeds to the Company of $ 258.8 million.

4 unchanged sentences

The Company deducted $ 0.2 million of expenses incurred related to this offering from additional paid-in capital in the accompanying consolidated balance sheet and reflected this within the proceeds from public offering of shares, net of issuance costs within the cash flows from financing activities.

On October 27, 2017, the Company completed a follow-on public offering of 5,000,000 ordinary shares at a public offering price of $ 18.25 per ordinary share, resulting in gross proceeds to the Company of $ 91.3 million.

The net proceeds to the Company from this offering were $ 85.3 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

The Company deducted $ 0.5 million of expenses incurred related to this from additional paid in capital in the accompanying consolidated balance sheet and reflected this within the proceeds from public offering of shares, net of issuance costs within the cash flows from financing activities.

In February 2019, the Company issued 37,175 ordinary shares to Hercules pursuant to exercised warrants for $ 0.5 million in aggregate cash consideration.

1 unchanged sentence

Hercules represented to us that they were in compliance with the requirements of Regulation S.

In December 2017 the Company issued a total of 114,172 restricted ordinary shares in relation to the exercise of 128,710 warrants issued to former lenders of a loan, which was converted into equity in July 2013 prior to the Company’s initial public offering.

The ordinary shares were issued at an exercise price of € 10.10 , or approximately $ 12.0 depending on the foreign exchange rate as of the date of warrant exercise.

In 2017, certain of these lenders (Forbion and Coller) qualified as related parties to the Company at the time of the transaction.

On October 2, 2017, the Company issued 64,648 ordinary shares to the sellers of the Inocard business in connection with the amended purchase agreement by which the Company acquired the Inocard business.

No cash consideration was paid for the shares, as such shares were issued as amended consideration for the previous acquisition of the Inocard business.

The Company deemed the offer and issuance of these shares to be exempt from registration under the Securities Act in reliance on Regulation S of the Securities Act, as an offshore offering of securities and such shares were issued as restricted shares.

The sellers of the Inocard business represented to the Company that they were in compliance with the requirements of Regulation S.

On May 2, 2018, the Company and Leerink mutually terminated with immediate effect the September 2017 Sales Agreement with Leerink for an at-the-market offering program (“ATM program”).

The ATM program allowed for the offer and sale of up to 5 million ordinary shares at prevailing market prices from time to time.

The Company did not offer or sell any ordinary shares under the ATM program.

Share-based compensation

8 unchanged sentences

Share options

Restricted share units (“RSUs”)

Performance share units (“PSUs”)

Restricted share units

Performance share units

As of December 31, 2020, the unrecognized compensation cost related to unvested awards under the various share-based compensation plans were:

4 unchanged sentences

Performance share units

The Company satisfies the exercise of share options and vesting of RSUs and PSUs through newly issued shares.

The Company satisfies the exercise of share options and vesting of Restricted Share Units (“RSUs”) and Performance Share Units (“PSUs”) through newly issued shares.

The Company’s share-based compensation plans include the 2014 Amended and Restated Share Option Plan (the “2014 Plan”) and inducement grants under Rule 5653(c)(4) of The Nasdaq Global Select Market with terms similar to the 2014 Plan (together the “2014 Plans”).

The Company previously had a 2012 Equity Incentive Plan (the “2012 Plan”).

As of December 31, 2020, 14,000 fully vested share options are outstanding (December 31, 2019:

14,000 ) under the 2012 Plan.

At the general meeting of shareholders on January 9, 2014, the Company’s shareholders approved the adoption of the 2014 Plan.

16 unchanged sentences

Thereof, fully vested and exercisable at December 31, 2020

Thereof, outstanding and expected to vest at December 31, 2019

Thereof, outstanding and expected to vest after December 31, 2020

Outstanding and expected to vest at December 31, 2019

28 unchanged sentences

Intrinsic value

Restricted Share Units (RSUs)

(in thousands)

Restricted Share Units

The following table summarizes the RSU activity for the year ended December 31, 2020:

13 unchanged sentences

(in thousands)

RSUs vest over one to three years .

RSUs generally vest over one to three years .

RSUs granted to non-executive directors will vest one year from the date of grant.

Performance Share Units (PSUs)

Performance Share Units

The following table summarizes the PSU activity for the year ended December 31, 2020:

4 unchanged sentences

Non-vested at December 31, 2020

PSUs awarded but not yet earned

Total non-vested and discretionary PSUs

Total weighted average grant date fair value of PSUs granted and awarded during the period (in $ millions)

Total weighted average grant date fair value of PSUs granted during the period (in $ millions)

In January 2019, the Company awarded PSUs to its executives and other members of senior management.

14 unchanged sentences

During the year ended December 31, 2020, 6,181 shares have been issued (December 31, 2019:

9,202 and December 31, 2018:

As of December 31, 2020, a total of 132,026 ordinary shares remains available for issuance under the ESPP plan.

The following table summarizes option activity under the Company’s 2012 Plan for the year ended December 31, 2019:

Weighted average

Aggregate intrinsic

exercise price

remaining contractual life

(in thousands)

Outstanding at December 31, 2018

Outstanding, fully vested and exercisable at December 31, 2019

Proceeds from option sales (in million)

The following table summarizes information about options exercised during the years ended December 31:

during the year

Intrinsic value

(in thousands)

Expenses by nature

11 unchanged sentences

Years ended December 31,

in thousands, except for employee numbers

(in thousands)

Wages and salaries

5 unchanged sentences

Other employee expenses

Number of employees at the end of the period

Other non-operating income / (expense)

Other non-operating income / (expense) consists of changes in the fair value of derivative financial instruments.

Other non-operating income / (expense) consists of changes in the fair value of derivative financial instruments (see Note 4, “Fair value measurement”).

Years ended December 31,

5 unchanged sentences

Derivative losses

Finance expenses

Total other non-operating expense:

Other non-operating income / (expense), net

The Company recorded a net loss of $ 2.3 million for the year ended December 31, 2019, compared to a net gain of $ 0.5 million and a net loss of $ 1.2 million for the years ended December 31, 2018 and December 31, 2017, respectively, related to the derivative financial instruments issued as part of its collaboration with BMS and a net loss of $ 0.2 million for the year ended December 31, 2019 (December 31, 2018:

$ 0.3 million net loss;

December 31, 2017:

$ 0.3 million net loss) related to warrants issued to Hercules (see note 4, “Fair value measurement”).

Also, the Company recognized a $ 0.7 million loss for the year ended December 31, 2017, related to warrants issued in connected with the 2013 convertible loan.

The Company recorded a net gain of $ 0.5 million for the year ended December 31, 2020, compared to a net loss of $ 2.3 million and a net gain of $ 0.5 million for the years ended December 31, 2019 and December 31, 2018, respectively, related to the derivative financial instruments issued as part of its collaboration with BMS.

The $ 0.5 million gain for the year ended December 31, 2020 includes a $ 2.3 million gain related to the reduction of the fair market value of the BMS warrants, a $ 0.8 million gain related to the derecognition of the BMS warrants on December 1, 2020 and a $ 2.6 million loss related to the initial recognition of the derivative financial liability related to the CoC-payment.

The Company recorded a net loss of $ 0.2 million and $ 0.3 million for the years ended December 31, 2019 and December 31, 2018, respectively, related to warrants issued to Hercules.

Income tax benefit / (expense)

No current tax charges or liabilities were recorded in 2019 by the Company’s Dutch and U.S entities.

Due to the uncertainty surrounding the realization of favorable tax attributes in future tax returns, the Company has recorded a full valuation allowance against the Company’s net deferred tax assets.

No current tax expense or liabilities were recorded in 2020 by the Company’s Dutch and U.S entities.

The Company released the full valuation allowance against the Company’s net deferred tax assets in the United States as of December 31, 2020.

There are no significant unrecognized tax benefits as of December 31, 2020 and 2019.

For the years ended December 31, 2020, 2019 and 2018, loss before income taxes consists of the following:

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(in thousands)

Current tax (expense) / benefit

Current tax expense

Dutch operations

Foreign operations

Total current income tax (expense) / benefit

Deferred tax (expense) / benefit

Total current tax expense

Deferred tax benefit / (expense)

Dutch operations

Foreign operations

Total deferred income tax (expense) / benefit

Total income tax (expense) / benefit

Total deferred tax benefit / (expense)

Total income tax benefit / (expense)

Tax rate reconciliation

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(in thousands)

Loss before income tax expense for the period

Loss before income tax income / (expense) for the period

Expected income tax benefit at the tax rate enacted in the Netherlands (25%)

Difference in tax rates between the Netherlands and foreign countries

Net change in valuation allowance

Non-deductible expenses

Difference in tax rates between the Netherlands and the U.S.

as well as other foreign countries

Release of valuation allowance related to expected future taxable income of U.S.

Other net change in valuation allowance

Nondeductible expenses

Change in fair value of contingent consideration

Income tax (expense) / benefit

Non-deductible expenses predominantly relate to share-based compensation expenses for an amount of $ 4.4 million in 2019 (2018:

$ 2.7 million;

$ 2.5 million) and non-deductible results on derivative financial instruments of $ 0.6 million (2018:

Income tax benefit / (expense)

Nondeductible expenses predominantly relate to share-based compensation expenses and affected the effective tax rate by an amount of $ 5.8 million in 2020 (2019:

$ 4.4 million;

$ 2.7 million).

Derivative financial instruments affected the effective tax rate by income of $ 0.8 million in 2020 (expense of $ 0.6 million in 2019;

$ 0.0 million in 2018), which reduced the nondeductible expenses resulting from share-based compensation expenses.

Significant components of deferred taxes

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Net operating loss carryforwards

Intangible assets

Lease liabilities

Intangible assets

Interest carryforwards

Accrued expenses and other current liabilities

Property, plant and equipment

Derivative financial instrument

Deferred revenue

Accrued expenses and other current liabilities

Gross deferred tax asset

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Right-of-use asset

Net deferred tax liability

Net deferred tax asset / (liability)

Prepaid expenses

Deferred tax liability

Net deferred tax asset

Changes in the valuation allowance were as follows:

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Changes recorded in profit and loss

Increase/(Reduction) related to 2019 and 2018, respectively, Dutch tax reforms

Reduction related to 2017 US tax reform

Increase/(reduction) related to 2020, 2019 and 2018 Dutch tax reforms

Release of valuation allowance related to expected current year and future periods recorded in profit and loss

Other changes including currency translation effects

Included within changes recorded in profit and loss for the year ended December 31, 2019 is the utilization of $ 3.7 million of U.S.

net operating loss carryforwards ($ 4.5 million utilization for the year ended December 31, 2018 and $ 0.0 for the year ended December 31, 2017).

The valuation allowance at December 31, 2019 was primarily related to net operating loss carryforwards that, in the judgment of management, are not more-likely than-not to be realized.

Included within changes recorded in profit and loss for the year ended December 31, 2020 are benefits of $ 1.2 million from the utilization of U.S.

net operating loss carryforwards ($ 0.8 million for the year ended December 31, 2019 and $ 0.9 million for the year ended December 31, 2018).

The valuation allowance as of December 31, 2020 is primarily related to net operating loss carryforwards in the Netherlands that, in the judgment of management, are not more-likely than-not to be realized.

In addition, the valuation allowance as of December 31, 2019 included deferred tax assets for net operating loss carryforwards and temporary differences in the United States of America.

Management considered projected future taxable income and tax-planning strategies in making this assessment.

There is also a portion of the valuation allowance for deferred tax assets for which subsequently measured tax benefits will be credited directly to contributed capital as it relates to follow-on offering costs.

A valuation allowance will be recorded against deferred tax assets if it is more likely than not that some or all the deferred tax assets will not be realized.

The Company determined that in accordance with Dutch tax law it would recognize the CSL Behring License Revenue as well as the License Fees as taxable results as of the date on which the Company is contractually entitled to receive (or obligated to make) a payment under the CSL Behring Agreement.

The Company expects to continue to incur taxable losses in the Netherlands except for the period in which it would receive the $ 450.0 million upfront payment under the CSL Behring Agreement.

In the event that the Company recognizes the $ 450.0 million upfront payment in 2021, such payment is expected to be subject to Dutch corporate income tax at a rate of 25.0 %.

However, the Company does not expect that it will be required to pay any income taxes in the period in which it recognizes the $ 450.0 million upfront payment as taxable revenue, as such payment is not expected to exceed the net operating losses that it carries forward in the Netherlands.

The Company specifically assessed the impact of the CSL Behring agreement with respect to retaining a full valuation allowance as of December 31, 2020.

Closing of the CSL Behring Agreement is contingent on the successful completion of reviews under the antitrust laws in the United States, Australia, and the United Kingdom.

The transactions have not closed as of December 31, 2020 as the Company received a Second Request from the United States Federal Trade Commission, on January 4, 2021.

Closing of the transaction is dependent on the timing, extent, and result of the Second Request.

In its assessment of whether or not it was more likely than not that the Company’s deferred tax assets in the Netherlands will be realized, the Company considered all relevant facts and circumstances, including similar regulatory reviews as well as the five-year cumulative losses reported by the Company in the Netherlands.

The Company concluded that it should continue to record a full valuation allowance as of December 31, 2020 in relation to its Dutch net operating loss carryforwards.

A portion of the valuation allowance for deferred tax assets relates to follow-on offering costs.

Any subsequently recognized tax benefits will be credited directly to contributed capital.

As of December 31, 2020, that amount was $ 7.7 million ($ 6.9 million as of December 31, 2019).

In the Netherlands, changes to corporate taxes were enacted in December 2019.

The changes increase the corporate tax rate from 22.55 % to 25.00 % for the fiscal year 2020 and decrease the corporate tax rate to 21.7 %, effective January 1, 2021.

The Company remeasured its deferred tax assets and liabilities using a rate of 21.7 % instead of the 20.5 % rate effective in 2019 as it does not expect to utilize any of its loss carryforwards prior to 2021.

This resulted in a $ 4.1 million increase of both the gross deferred tax asset and the valuation allowance in the year ended December 31, 2019.

The change is attributable to changes in the foreign currency rate.

The Dutch corporate tax rate for fiscal years 2018, 2019 and 2020 was 25 %.

During the years 2018 and 2019, the Dutch government enacted various changes to the corporate income tax rate applicable to future fiscal years.

In September 2020, further changes were enacted that retain the corporate rate at 25 % from 2021 onwards.

A tax reform in December 2018 limited the carryforward of tax losses arising from January 1, 2019, to six years after the end of the respective period.

Tax losses incurred prior to this date continue to expire nine years after the end of the respective period.

The 2018 Dutch tax reform had initially lowered the tax rate from 25.0 % to 20.5 %.

This rate reduction was partially reversed through the 2019 Dutch tax reform.

The Dutch fiscal unity has as of December 31, 2019 an estimated $ 414.0 million (2018:

As of December 31, 2020, new loss compensation rules were accepted by the Dutch Senate.

However, the bill includes a provision that the new compensation rules will be effective by a separate Governmental Decree, which has not been introduced as of December 31, 2020.

Hence, the new loss compensation rules are not enacted as of December 31, 2020.

If enacted, the rules allow losses to be carried forward indefinitely, but from fiscal year 2022 onwards would limit offsetting taxable profit in excess of EUR 1.0 million to 50% of the taxable profit.

The Dutch fiscal unity as of December 31, 2020 has an estimated $ 588.2 million (2019:

$ 414.0 million;

$ 246.0 million) of taxable losses that can be offset in the following six to eight years .

The expiration dates of these Dutch

losses are summarized in the following table.

$ 311.7 million) of taxable losses that can be offset in the following six to seven years .

The expiration dates of these Dutch losses are summarized in the following table.

In the year ended December 31, 2020 unused tax losses of $ 18.5 million (December 31, 2019:

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Loss expiring

In the U.S., the tax act known as the Tax Cuts and Jobs Act (“the Act”) was enacted on December 22, 2017.

The Act reduced the corporate tax rate from 35 % to 21 %, effective January 1, 2018.

As a foreign domiciled entity, the most significant impact of the Act related to the tax rate applicable to the Company’s U.S.

operating entity, resulting in a $ 1.7 million reduction of both the gross deferred tax asset and the valuation allowance in the year ended December 2017.

In addition, the Act limits the utilization of tax losses incurred after January 1, 2018, to 80 % of taxable income.

The Company did not identify any further significant impacts related to the Act during 2018.

The tax losses incurred prior to January 1, 2018 are approximately $ 55.1 million.

As of December 31, 2019, the estimated remaining tax losses available for carry forward are $ 46.7 million.

The fiscal periods after 2017 are still open for inspection by the Dutch tax authorities.

United States of America

The federal corporate tax rate in the U.S.

In addition, the Company is subject to state taxes resulting in a combined tax rate of 27.32 % for its U.S.

As of December 31, 2020, an estimated $ 42.3 million of net operating losses remain to be carried forward.

These losses will expire between 2035 and 2037.

The Company’s U.S.

operations generated taxable income in the fiscal years 2018, 2019 and 2020.

Based on the current design of the Company’s worldwide operations, the Company expects to continue to generate taxable income in the U.S.

during the foreseeable future.

As of December 31, 2020, the Company considers it more likely than not that it will utilize its net deferred tax assets in the U.S.

and therefore released the remaining valuation allowance of $ 16.4 million through profit and loss as of this date.

Under the provision of the Internal Revenue Code, the U.S.

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Subsequent ownership changes may further affect the limitation.

There are no significant unrecognized tax benefits as of December 31, 2019 and 2018.

The fiscal periods after 2017 are still open for inspection by the Internal Revenue Service.

The Company is currently not under examination by the IRS for any tax years.

Basic and diluted earnings per share

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As the Company has incurred a loss in the years presented, all potentially dilutive ordinary shares would have an antidilutive effect, if converted, and thus have been excluded from the computation of loss per share.

The shares are presented without giving effect to the application of the treasury method or exercise prices that would be above the share price as of December 31, 2020, December 31, 2019, and December 31, 2018, respectively.

In addition, the BMS warrants were not exercisable as of December 31, 2019, and December 31, 2018, since this would have required the prior designation of Collaboration Targets by BMS.

This would generally have resulted in a lower number of potentially dilutive ordinary shares as some stock option grants as well as the BMS warrants would have been excluded.

The potentially dilutive ordinary shares are summarized below:

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(ordinary shares)

BMS warrants (derecognized as of December 1, 2020 - see Note 4, "Fair value measurement")

Stock options under 2014 Plans

Non-vested RSUs and earned PSUs

Stock options under 2012 Plan

Stock options under previous option plan

Hercules warrants (exercised February 1, 2019)

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Commitments and contingencies

In the course of its business, the Company enters as a licensee into contracts with other parties with regard to the development and marketing of its pipeline products.

In the course of its business, the Company enters as a licensee into contracts with other parties regarding the development and marketing of its pipeline products.

Among other payment obligations, the Company is obligated to pay royalties to the licensors based on future sales levels and milestone payments whenever specified development, regulatory and commercial milestones are met.

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Related party transaction

On August 20, 2019, the Company promoted Sander van Deventer, M.D., Ph.D., to Executive Vice President, Research and Product Development, and Alex Kuta, Ph.D., to Executive Vice President, Operations.

van Deventer, in addition to his responsibilities for research, will now also be responsible for the Company’s product development.

Kuta, in addition to regulatory affairs, will now also be responsible for global quality as well as GMP manufacturing at uniQure’s state-of-the-art facility in Lexington, Massachusetts.

As a result of these changes, the Company eliminated the Chief Operating Officer role, and Scott McMillan, Ph.D.

Between June 2015 and December 2020, BMS was considered a related party due to the combination of its equity investment in the Company (December 31, 2020:

2.4 million ordinary shares or 5.3 % of outstanding ordinary shares), the warrants as well as the potential obligations arising from the expansion of collaboration targets.

On December 1, 2020, the Company entered into the amended BMS CLA.

All transactions subsequent to the effective date of the amended BMS CLA are considered to no longer be with a related party due to the elimination of the potential obligations related to additional Collaboration Targets (see Note 3 “Collaboration arrangements and concentration of credit risk”) as well as the elimination of the BMS warrants (see Note 4, “Fair value measurement”).

On September 14, 2020, the Company appointed Ricardo Dolmetsch, Ph.D.

as President, Research and Development.

Dolmetsch succeeded Sander van Deventer, M.D., Ph.D., the former Executive Vice President, Research and Product Development.

On August 25, 2020, the Company entered into a separation agreement with Robert Gut, M.D., Ph.D., pursuant to which Dr.

Gut transitioned from his role as Chief Medical Officer on October 14, 2020, to be appointed a non-executive director of the Board of Directors.

On December 1, 2020, at an extraordinary general meeting, the Company’s shareholders voted to approve the appointment of Dr.

Gut as a non-executive director on the Board of Directors.

Gut had previously been appointed as a non-executive director on the Board of Directors on June 13, 2018 by the Company’s shareholders and had resigned as a non-executive director on August 20, 2018, to be appointed as the Company’s Chief Medical Officer.

On October 24, 2018, at an extraordinary general meeting, the Company’s shareholders voted to approve the appointment of Dr.

Gut as an executive director on the Board of Directors.

On June 17, 2020, the Company’s shareholders voted to approve the appointment of Leonard E.

Post, Ph.D., as a non-executive director of the Board of Directors.

Post replaced Dr.

David Schaffer, whose term as a non-executive director of the Board of Directors ended on the same date.

Post has also assumed the role of chair of the Company’s Research and Development Committee of the Board of Directors.

On August 20, 2019, the Company promoted Alex Kuta, Ph.D., to Executive Vice President, Operations.

Kuta, in addition to regulatory affairs, became responsible for global quality as well as GMP manufacturing at the Company’s facility in Lexington, Massachusetts.

As of the same date Sander van Deventer, M.D., Ph.D., was promoted to Executive Vice President, Research and Product Development, and Dr.

van Deventer, in addition to his responsibilities for research, also became responsible for the Company’s product development.

As a result of these changes Scott McMillan, Ph.D.

retired from uniQure.

The employment of Dr.

van Deventer terminated on September 14, 2020.

In August 2019, the Company entered into an Amended and Restated Agreement Collaboration and License Agreement (“Amended CLA”) as well as an additional new Collaboration and License Agreement (“New CLA”) with its related party 4DMT Molecular Therapeutics, Inc.

In the Amended CLA, the Company received from 4DMT an exclusive, sublicensable, worldwide license under certain 4DMT intellectual property rights to research, develop, make, use, and commercialize previously selected AAV capsid variants and certain associated products using 4DMT proprietary AAV technology for delivery of gene therapy constructs to cells in the central nervous system and the liver (“the Field”).

In the Amended CLA, the Company received from 4DMT an exclusive, sublicensable, worldwide license under certain 4DMT intellectual property rights to research, develop, make, use, and commercialize previously selected Adeno-associated virus (“AAV”) capsid variants and certain associated products using 4DMT proprietary AAV technology for delivery of gene therapy constructs to cells in the central nervous system and the liver (“the Field”).

In the New CLA, the parties agreed to research and develop, at 4DMT’s cost, new AAV capsid variants using 4DMT proprietary AAV technology for delivery of up to six additional transgene constructs in the Field that will be selected by the Company.

On June 13, 2018, the Company shareholders voted to approve the appointment of Robert Gut, M.D., Ph.D.

as a non-executive director on our Board of Directors.

On August 20, 2018, Dr.

Gut was appointed as the Company’s Chief Medical Officer following his resignation as a non-executive director.

On October 24, 2018, at an extraordinary general meeting, the Company’s shareholders voted to approve the appointment of Dr.

Gut as executive director on the Board of Directors.

Gut’s annual base salary will be $ 425,000 and he will be eligible for an annual bonus of 40 % of his base salary.

Gut was granted 35,000 restricted stock units vesting in equal installments over three years as well as an option to purchase 70,000 ordinary shares of the Company that will vest over a period of four years .

In addition, Dr.

Gut retains his option to purchase 10,000 ordinary shares vesting over three years , which he was granted upon his appointment as a non-executive director in June 2018.

On August 7, 2017, the Company appointed Dr.

Sander van Deventer as its Chief Scientific Officer and General Manager of its Amsterdam site.

van Deventer served on the Company’s Board of Directors until September 14, 2017.

van Deventer has resigned as Managing Partner of Forbion Capital Partners and became an Operating Partner with Forbion Capital Partners for up to 50% of his time.

van Deventer is entitled to € 200,000 gross annual salary (“Base Salary”), including an 8 % holiday allowance to be paid annually in May based upon the previous year’s gross annual salary.

van Deventer will also be eligible for a bonus amounting to a maximum of 40 % of his annual gross salary, such amount to be determined by the Board of Directors.

On September 20, 2017, Dr.

van Deventer was granted an option to purchase 150,000 shares with an exercise price of $ 8.49 , in accordance with the Company’s Amended and Restated 2014 Share Incentive Plan.

As of June 2020, 4DMT is no longer considered a related party as a result of David Schaffer no longer being a non-executive member of the Company’s Board of Directors.

Subsequent events

Amendment Loan Facility

As of December 31, 2020, a $ 35.0 million term loan was outstanding in accordance with the 2018 Amended Facility between the Company and Hercules.

On January 29, 2021, the Company and Hercules amended the Company’s loan facility with Hercules Capital Inc.

entered, (“2021 Amended Facility”).

Pursuant to the 2021 Amended Facility, Hercules agreed to the 2021 Term Loan, increasing the aggregate principal amount of the term loan facility from $ 35.0 million to $ 135.0 million.

On January 29, 2021, the Company drew down $ 35.0 million of the 2021 Term Loan.

The Company may draw down the remaining $ 65.0 million under the 2021 Term Loan in a series of one or more advances of not less than $ 20.0 million each until December 15, 2021.

Advances under the 2021 Term Loan bear interest at a rate equal to the greater of (i) 8.25 % or (ii) 8.25 % plus the prime rate, less 3.25 % per annum.

The principal balance and all accrued but unpaid interest on advances under 2021 Term Loan is due on June 1, 2023, which date may be extended by the Company by up to two twelve-month periods.

Advances under the 2021 Term Loan may not be prepaid until six months after the Closing Date, following which the Company may prepay all such advances without charge.

In addition to the 2021 Term Loan, the amendment also extends the interest-only payment period of the previously funded $ 35.0 million term loan from January 1, 2022 to June 1, 2023.

The Company paid a $ 0.4 million facility charge on January 29, 2021.

End of term charges in respect of advances under the 2021 Term Loan range from 1.65 % to 6.85 % depending on the maturity date.

EXHIBIT INDEX

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001-36294) for the period ending on March 31, 2017 filed with the Securities and Exchange Commission).

Warrant Agreement, dated as of September 20, 2013, by and among the Company, uniQure Biopharma B.V.

and Hercules Technology Growth Capital, Inc.

(incorporated by reference to Exhibit 10.18 of the Company's registration statement on Form F-1 (file no.

333-193158) filed with the Securities and Exchange Commission).

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.

10 unchanged sentences

333-193158) filed with the Securities and Exchange Commission).

Collaboration and License Agreement, dated January 17, 2014, by and between uniQure biopharma B.V.

and 4D Molecular Therapeutics, LLC (incorporated by reference to Exhibit 10.32 of the Company's registration statement on Form F-1 (file no.

333-193158) filed with the Securities and Exchange Commission).

Second Amended and Restated Loan and Security Agreement, dated as of May 6, 2016 by and among uniQure Biopharma B.V., uniQure, Inc., uniQure IP B.V., the Company's subsidiaries listed therein, and Hercules Technology Growth Capital, Inc (incorporated by reference to Exhibit 10.30 of the Company's annual report on Form 10-K (file no.

3 unchanged sentences