What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2022-05-02 compared with 2021-10-25 · 148 added, 371 removed, 238 unchanged (69% of the section changed)

1 unchanged sentence

UNAUDITED CONSOLIDATED BALANCE SHEETS

September 30,

(in thousands, except share and per share amounts)

1 unchanged sentence

Cash and cash equivalents

Accounts receivable

Accounts receivable and contract asset

Prepaid expenses

2 unchanged sentences

Non-current assets

Property, plant and equipment, net of accumulated depreciation of $ 35.9 million as of September 30, 2021 and $ 35.2 million as of December 31, 2020, respectively

Property, plant and equipment, net of accumulated depreciation of $ 38.5 million as of March 31, 2022 and $ 36.9 million as of December 31, 2021, respectively.

Operating lease right-of-use assets

Intangible assets, net

Intangible assets, net, including an in-process research and development asset of $ 59.5 million

Deferred tax assets, net

4 unchanged sentences

Accrued expenses and other current liabilities

Current portion of contingent consideration

Current portion of operating lease liabilities

3 unchanged sentences

Operating lease liabilities, net of current portion

Contingent consideration

Deferred tax liabilities, net

Contingent consideration, net of current portion

Deferred tax liability, net

Other non-current liabilities

4 unchanged sentences

Ordinary shares, € 0.05 par value:

80,000,000 shares authorized as of September 30, 2021 and 60,000,000 shares authorized as of December 31, 2020 and 46,207,776 and 44,777,799 ordinary shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

80,000,000 shares authorized as of March 31, 2022 and December 31, 2021 and 46,641,448 and 46,298,635 ordinary shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively

Additional paid-in-capital

Accumulated other comprehensive (loss) / income

Accumulated other comprehensive loss

Accumulated deficit

3 unchanged sentences

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND

COMPREHENSIVE INCOME (LOSS)

Three months ended September 30,

Nine months ended September 30,

(in thousands, except share and per share amounts)

COMPREHENSIVE LOSS

Three months ended March 31,

(in thousands, except share and per share amounts)

License revenues

License revenues from related party

Collaboration revenues

Collaboration revenues from related party

Total revenues

Operating expenses:

Cost of contract revenues

Research and development expenses

2 unchanged sentences

Other expense

(Loss) / income from operations

Loss from operations

Interest income

Interest expense

Foreign currency gains / (losses), net

Foreign currency gains, net

Other non-operating gains, net

(Loss) / income before income tax expense

Income tax expense

Net (loss) / income

Other comprehensive (loss) / gain:

Loss before income tax benefit / (expense)

Income tax benefit / (expense)

Other comprehensive loss:

Foreign currency translation adjustments

Total comprehensive (loss) / gain

Earnings per ordinary share - basic

Basic net (loss) / income per ordinary share

Earnings per ordinary share - diluted

Diluted net (loss) / income per ordinary share

Weighted average shares - basic

Weighted average shares - diluted

Total comprehensive loss

Basic and diluted net loss per ordinary share

Weighted average shares used in computing basic and diluted net loss per ordinary share

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

UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

FOR THE THREE-MONTH PERIOD ENDED SEPTEMBER 30

FOR THE THREE-MONTH PERIOD ENDED MARCH 31

Ordinary shares

1 unchanged sentence

shareholders’

income / (loss)

(in thousands, except share and per share amounts)

Balance at June 30, 2020

Loss for the period

Other comprehensive income

Exercise of share options

Restricted share units distributed during the period

Share-based compensation expense

Issuance of ordinary shares relating to employee stock purchase plan

Balance at September 30, 2020

Balance at June 30, 2021

Balance at December 31, 2020

Loss for the period

Other comprehensive loss

Issuance of ordinary shares

Exercise of share options

2 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at September 30, 2021

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

UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

FOR THE NINE-MONTH PERIOD ENDED SEPTEMBER 30

Ordinary shares

comprehensive

shareholders’

(in thousands, except share data)

Balance at March 31, 2021

Balance at December 31, 2021

Loss for the period

Other comprehensive income

Exercise of share options

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 September 30, 2020

Balance at December 31, 2020

Income for the period

Other comprehensive loss

Issuance of ordinary shares

Tax benefit past share issuance cost

Exercise of share options

Restricted and performance share units distributed during the period

Restricted share units and performance share units distributed during the period

Share-based compensation expense

Issuance of ordinary shares relating to employee stock purchase plan

Balance at September 30, 2021

Balance at March 31, 2022

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

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

Nine months ended September 30,

Three months ended March 31,

(in thousands)

Cash flows from operating activities

Net income / (loss)

Adjustments to reconcile net income / (loss) to net cash generated from / (used in) operating activities:

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization expense

Share-based compensation expense

Deferred tax expense

Changes in fair value of contingent consideration and derivative financial instruments

Unrealized foreign exchange (gains) / loss, net

Other non-cash items, net

Deferred tax (income) / expense

Changes in fair value of contingent consideration and derivative financial instrument, net

Unrealized foreign exchange gains, net

Changes in operating assets and liabilities:

Accounts receivable, prepaid expenses, and other current assets and receivables

Accounts receivable and contract asset, prepaid expenses, and other current assets and receivables

Accounts payable

Accrued expenses, other liabilities, and operating leases

Net cash generated from / (used in) operating activities

Net cash used in operating activities

Cash flows from investing activities

Acquisition of Corlieve, net of cash acquired

Purchases of intangible assets

Purchases of property, plant, and equipment

Acquisition of remaining outstanding ordinary shares related to Corlieve acquisition

Net cash used in investing activities

Cash flows from financing activities

Proceeds from loan increment, net of debt issuance costs

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

Proceeds from issuance of ordinary shares

Share issuance costs from issuance of ordinary shares

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

Repayment of debt acquired through acquisition of Corlieve

Proceeds from loan increment, net of debt issuance costs

Net cash generated from financing activities

Currency effect on cash, cash equivalents and restricted cash

Net increase / (decrease) in 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

5 unchanged sentences

Cash paid for interest

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

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

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

13 unchanged sentences

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

GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting.

GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting.

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

9 unchanged sentences

GAAP have been omitted.

The results of operations for the nine months ended September 30, 2021, are not necessarily indicative of the results to be expected for the full year ending December 31, 2021, or for any other future year or interim period.

The accompanying financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 1, 2021 .

The results of operations for the three months ended March 31, 2022, are not necessarily indicative of the results to be expected for the full year ending December 31, 2022, or for any other future year or interim period.

The accompanying financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report .

2.3 Use of estimates

3 unchanged sentences

2.4 Accounting policies

The principal accounting policies applied in the preparation of these unaudited consolidated financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2020, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 1, 2021 .

There have been no material changes in the Company’s significant accounting policies during the nine months ended September 30, 2021, except as noted below.

Revenue recognition – CSL Behring Agreement

The Company determined its revenue recognition policies related to the CSL Behring Agreement (defined below) when the CSL Behring Agreement became fully effective on May 6, 2021.

Refer to Note 4 “Collaboration arrangements and concentration of credit risk” for further detail.

Earnings per ordinary share

The Company recognized net income for the first time in 2021.

The Company had a net loss for the three months ended September 30, 2021.

Net income / (loss) per ordinary share was calculated in accordance with ASC 260, Earnings Per Share.

Refer to Note 13 “Basic and diluted earnings per share” for further detail.

Corlieve transaction

The Company acquired Corlieve Therapeutics SAS (“Corlieve”) on July 30, 2021.

The Company determined the accounting for this transaction in accordance with ASC 805, Business Combination.

Refer to Note 3 “Corlieve transaction” for further detail.

The principal accounting policies applied in the preparation of these unaudited consolidated financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2021, and the notes thereto, which are included in the Company’s Annual Report .

There have been no material changes in the Company’s significant accounting policies during the three months ended March 31, 2022.

2.5 Recent accounting pronouncements

There have been no new accounting pronouncements or changes to accounting pronouncements during the nine months ended September 30, 2021, as compared to the recent accounting pronouncements described in Note 2.3.22 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 , which could be expected to materially impact the Company’s unaudited consolidated financial statements.

3 Corlieve transaction

On July 30, 2021 (“Acquisition Date”), the Company acquired Corlieve.

Following Corlieve’s formation in November 2019, Corlieve obtained exclusive licenses to certain patents from two French research institutions that continue to collaborate with the Company.

At the same time Corlieve also obtained an exclusive license from Regenxbio Inc.

to use AAV9 to deliver any sequence that affects the expression of the Glutamate inotropic receptor kainate type subunit 2 (“GRIK 2”) gene sequence in humans.

Corlieve and Regenxbio Inc.

simultaneously entered into a collaboration plan related to agreed joint preclinical research and development activities.

At the Acquisition Date, Corlieve and its Swiss subsidiary, Corlieve Therapeutics AG, employed seven employees.

The Company evaluated the Corlieve transaction as to whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets.

Based on the provisional fair values of the gross assets acquired, the Company determined the screen test was not met.

The Company further analyzed whether or not the acquired inputs and processes that have the ability to create outputs would meet the definition of a business.

Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.

Identifiable assets and liabilities of Corlieve, including identifiable intangible assets, were recorded at their fair values as of the Acquisition Date, when the Company obtained control.

The excess of the fair value of the consideration transferred over the fair value of the net assets acquired was recorded as goodwill.

The following table summarizes the provisional fair values assigned to assets acquired and the liabilities assumed by the Company, along with the resulting goodwill, as of the Acquisition Date:

(in thousands)

Consideration

Contingent consideration

Liability related to mandatorily redeemable shares

Fair value of total consideration

Recognized amounts of identifiable assets acquired and liabilities assumed

Current assets including € 2.8 million of cash

Property, plant and equipment

Identifiable intangible asset

Current liabilities

Deferred tax liability, net

Other non-current liabilities

Fair value of net assets acquired

Consideration

On the Acquisition Date, the Company acquired 97.7 % of the outstanding ordinary shares of Corlieve for EUR 44.9 million ($ 53.3 million).

The Company is contractually required to acquire the remaining outstanding ordinary shares in February 2022 following the expiration of a minimum holding period.

The Company recorded a liability related to these mandatorily redeemable shares for an amount of EUR 0.7 million ($ 0.9 million) as of the Acquisition Date.

The Company financed the transaction from its cash on hand.

In addition, Corlieve’s former shareholders are eligible to receive up to EUR 35.8 million ($ 42.5 million) upon achievement of certain development milestones through Phase I/II and EUR 143.1 million ($ 169.9 million) upon achievement of certain milestones associated with Phase III development and obtaining approval to commercialize Corlieve’s target candidate for the treatment of temporal lobe epilepsy (“AMT-260” or “TLE”) in the United States of America and the European Union.

The Company may elect to pay up to 25 % of such milestone payments through the issuance of the Company’s ordinary shares.

As of the Acquisition Date, the Company recorded EUR 20.2 million ($ 24.0 million) as a contingent liability (presented as “Non-current liability”) for the fair value of these milestone payments.

The fair value of the liability for the contingent consideration was determined using unobservable inputs with respect to (i) the probability of achieving the relevant milestones, or probability of success (“POS”), (ii) the estimated timing of achieving such milestones, and (iii) the interest rate used to discount the payments.

The Company determined the fair market value of the contingent consideration by calculating the probability-adjusted payments based on each milestone’s probability of achievement.

The probability-adjusted payments were then discounted to present value using a discount rate representing the Company’s credit risk based on the estimated timing of achieving the milestones.

The unobservable inputs were estimated within a range of inputs.

Varying the inputs within the range of inputs considered by the Company would not result in a material change of the fair value of contingent consideration as of the Acquisition Date.

Increasing the POS of AMT-260 advancing into clinical development by 5 % would increase the fair value of contingent consideration by $ 1.9 million to $ 25.9 million as of the Acquisition Date.

Similarly reducing the estimated timing of achieving such milestones by six months would reduce the fair value of contingent consideration by $ 1.3 million to $ 25.3 million as of the Acquisition Date.

The Company subsequently measures the contingent liability at its fair value.

The fair value of the contingent liability as of September 30, 2021 amounted to EUR 20.5 million ($ 23.8 million).

Changes in fair value of the contingent liability are recognized within research and development expenses in the consolidated statements of operations.

Identified intangible assets

The Company identified various licenses that combined with the results of the research and development activities conducted in relation to AMT-260 since incorporation of Corlieve in 2019 constitute an In-process research and development intangible asset (“IPR&D intangible asset”).

The Company determined the fair value of the IPR&D intangible asset using a present value model based on expected cash flows.

Estimating the amounts and timing of cash flows required to complete the development of AMT-260 as well as net sales, cost of goods sold, and sales and marketing costs involved considerable judgment and uncertainty.

The expected cash flows are materially impacted by the probability of successfully completing the various stages of development (i.e., dosing of first patient in clinical trial, advancing into late-stage clinical development and obtaining approval to commercialize a product candidate) as well as the weighted average cost of capital of 10.4 % used to discount the expected cash flows.

Based on all such information and its judgment the Company estimated the fair value of the IPR&D intangible asset at EUR 53.3 million ($ 63.3 million) as of the Acquisition Date.

The IPR&D intangible asset is considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts and is not amortized.

If and when development is completed, which generally occurs when regulatory approval to market a product is obtained, the associated asset would be deemed finite-lived and would then be amortized based on its respective useful life at that point in time.

In case of abandonment, the IPR&D intangible asset will be written-off.

In accordance with ASC 350, Intangibles – Goodwill and Other, the Company tests indefinite-lived intangible assets for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate the fair value of the IPR&D intangible asset is below its carrying amount.

Deferred tax liability, net

Corlieve’s deferred tax assets at the time of acquisition amounted to EUR 1.8 million ($ 2.2 million).

Recognition of the IPR&D intangible asset gave rise to a deferred tax liability of EUR 13.3 million ($ 15.8 million) at the enacted French corporate income tax rate of 25.0 %.

The Company consequently recorded a net deferred tax liability of EUR 11.5 million ($ 13.6 million) as of the Acquisition Date.

Changes in the net deferred tax liability after the Acquisition Date will be recorded in income tax expense in the consolidated statements of operations.

Goodwill represents the excess of total consideration over the estimated fair value of net assets acquired.

The Company recorded EUR 23.8 million ($ 28.2 million) of goodwill in the consolidated balance sheet as of the Acquisition Date.

The Company allocated the goodwill to its only reporting unit.

The Company does not expect any portion of this goodwill to be deductible for tax purposes.

Goodwill is not amortized but is evaluated for impairment on an annual basis and between annual tests, in accordance with ASC 350, Intangibles – Goodwill and Other, if the Company becomes aware of any events occurring or changes in circumstances that would more likely than not reduce the fair value of the corporate reporting unit below its carrying amount.

Provisional fair values

The provisional determination of the fair value for the IPR&D intangible asset required considerable judgment.

As of September 30, 2021, the valuation of this item has not yet been finalized.

The Company will adjust the provisional valuation of identifiable assets and assumed liabilities for any material additional information regarding the fair values that becomes available until it finalized its valuation.

Any such adjustments might also impact the deferred tax liability as well as goodwill.

The finalization of the valuation might change the outcome of the screen test requiring the Company to treat the transaction as an asset acquisition.

In accordance with ASC 805, the Company in this case, among others, would not record any goodwill and expense all identifiable intangible assets without alternative future use.

As of the Acquisition Date, Corlieve held a loan with outstanding amount equal to EUR 1.0 million ($ 1.2 million), which loan was repaid in its entirety in September 2021.

There have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2022, as compared to the recent accounting pronouncements described in Note 2.3.23 of the Company’s Annual Report , which could be expected to materially impact the Company’s unaudited consolidated financial statements.

Collaboration arrangements and concentration of credit risk

1 unchanged sentence

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

On May 6, 2021, a day after the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the CSL Behring Agreement became fully effective (“Closing”).

Pursuant to the CSL Behring Agreement, the Company received a $ 450.0 million upfront cash payment and $ 12.4 million in other payments related to the Closing and the transfer of the license.

The Company is eligible to receive up to $ 1.6 billion in additional payments based on the achievement of 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.

On the Signing Date, the Company and CSL Behring entered into a development and commercial supply agreement, pursuant to which, among other things, the Company will supply the Product to CSL Behring at an agreed-upon price commensurate with the stand-alone selling price (“SSP”).

The Company will be responsible for supplying development and commercial Product until such time that these capabilities may be transferred to CSL Behring or a designated contract manufacturing organization.

The Company will be completing the HOPE-B clinical trial and the validation of the manufacturing process on behalf of CSL Behring, as well as provide further development services if requested by CSL Behring.

Activities related to on-demand development services as well as activities related to the completing the HOPE-B clinical trial will be reimbursed by CSL Behring at an agreed full-time-employee rate (“FTE-rate”) and CSL Behring will also reimburse agreed third-party expenses incurred in relation to performing these activities.

The validation of the manufacturing process as well as the development and validation of a next generation manufacturing process (“Manufacturing Development Services”) will be reimbursed through a future milestone payment.

If completed after certain contractually agreed upon dates, the milestone payment will be reduced in accordance with a pre-specified mechanism.

The Company concluded that CSL Behring is a customer in accordance with Topic 606.

The transaction became fully effective on May 6, 2021, one day after the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”) expired on May 5, 2021 (“Closing”).

The Company identified two material performance obligations related to the CSL Behring Agreement:

(i) Sale of the exclusive global rights to the Product (“License”);

(i) Sale of the exclusive global rights to the Product (“License Sale”);

(ii) Generate information to support the regulatory approval of the current and next generation manufacturing process of Product and to provide any such information generated to CSL Behring (“Manufacturing Development”).

These performance obligations are considered distinct from one another, as CSL Behring can benefit from the identified service either on its own or together with other resources that are readily available to CSL Behring, and as the performance obligations are separately identifiable from other performance obligations in the CSL Behring Agreement.

The Company continued to develop the Product between the Signing Date and Closing and performed certain reimbursable activities to fulfill the transfer of the global rights (“Additional Covenants” and together with the License the “License Sale”).

The Additional Covenants are not considered distinct from the performance obligation to sell the license to CSL Behring as CSL Behring could not benefit from the Additional Covenants on their own, or have these activities be performed with readily available resources.

The Company determined that the fixed upfront payment of $ 450.0 million and the $ 12.4 million that the Company received in relation to the Additional Covenants should be allocated to the License Sale.

In addition, the Company concluded that variable milestone payments, sales milestone payments and royalties should be allocated to the License Sale performance obligation as well.

The Company determined that the sale of the License was completed on May 6, 2021, when it transferred the License and CSL Behring assumed full responsibility for the development and commercialization of the Product.

The Company determined that the License Sale was completed on May 6, 2021, when it transferred the license and CSL Behring assumed full responsibility for the development and commercialization of the Product.

At Closing, the Company evaluated the amounts of potential payments and the likelihood that the payments will be received.

2 unchanged sentences

The Company determined that it would recognize revenue related to these payments only to the extent that it becomes probable that no significant reversal of recognized cumulative revenue will occur thereafter.

Similarly, the Company will record expenses related to its existing license and other agreements as well as its financial advisor for a high single digit percentage of any such revenue recognized associated to meeting a milestone.

The Company will include payments related to sales milestones in the transaction price when their achievement becomes probable, and it will include royalties on the sale of Product once these have been earned.

The Company recognized nil and $ 462.4 million of revenues related to the License Sale in the three and nine months ended September 30, 2021, respectively, compared to nil in the same periods in the prior year.

The costs associated with fulfilling this performance obligation are presented as “Cost of contract revenue” with the exception of the cost incurred prior to the Closing, which had been presented as “Research and development expenses ”.

The Company determined that the variable milestone payment related to Manufacturing Development Services should be allocated to the Manufacturing Development performance obligation.

The Company concluded that this milestone payment represents the SSP of the services based on the estimated cost of providing the services including a reasonable margin.

The services related to Manufacturing Development will be provided between Closing and the completion of an agreed manufacturing development plan.

The variable consideration will be reduced if the Company does not complete the development by pre-agreed dates.

The Company utilized the most likely amount method to estimate the variable consideration to be included in the transaction price.

Completion of Manufacturing Development is partially dependent on the timing of regulatory submissions by CSL Behring as well as regulatory approvals of the developed manufacturing processes.

Since the Company cannot control the timing or outcome of any regulatory decisions, the Company concluded that it would recognize revenue related to this payment when it becomes probable that the milestone has been achieved.

The Company did not recognize any revenue related to Manufacturing Development during the three and nine months ended September 30, 2021.

The Company recognized $ 0.5 million and $ 0.9 million of collaboration revenue in the three and nine months ended September 30, 2021, respectively, compared to nil in the same periods in the prior year.

The Company generates such collaboration revenue from services rendered in relation to completing the HOPE-B clinical trial on behalf of CSL Behring.

CSL Behring may request additional development services or request the Company to support the transfer of manufacturing to a party designated by CSL Behring.

These collaboration services will be reimbursed at the pre-agreed FTE-rate.

The Company concluded that these rights at Closing do not represent material rights.

As of September 30, 2021, the Company has accounts receivable of $ 1.9 million from CSL Behring.

Following the Closing, the Company collected the $ 2.1 million of accounts receivable related to reimbursable contract fulfillment costs that was outstanding as of December 31, 2020.

Similarly, the Company records expenses related to its existing license and other agreements as well as its financial advisor for a mid-single digit percentage of any such revenue recognized associated to meeting a milestone.

The Company includes payments related to sales milestones in the transaction price when their achievement becomes probable, and it will include royalties on the sale of Product once these have been earned.

During the three months ended March 31, 2022, the Company did no t recognize any license revenue ( nil for same period in 2021).

The Company recognized $ 1.4 million of collaboration revenue in the three months ended March 31, 2022, compared to nil in the same period in 2021.

The Company generates such collaboration revenue from services rendered in relation to completing the HOPE-B clinical trial on behalf of CSL Behring as well as additional development services that CSL Behring requested.

These collaboration services are reimbursed at the pre-agreed full-time-employee rate (“FTE-rate”).

As of December 31, 2021, the Company recorded accounts receivable of $ 2.9 million from CSL Behring related to clinical development services as well as a contract asset of $ 55.0 million associated with milestone payments due upon CSL Behring’s global regulatory submissions for etranacogene dezaparvovec, which were deemed to be probable.

In March 2022, CSL Behring submitted the global regulatory submissions, and as of March 31, 2022, the Company collected $ 20.0 million of the total $ 55.0 million owed.

As of March 31, 2022, the Company had accounts receivable of $ 38.3 million from CSL Behring, $ 35.0 million of which were related to the uncollected milestone payment associated with the global regulatory submissions.

The remaining $ 35.0 million was received in April 2022.

Bristol-Myers Squibb collaboration

In May 2015, the Company and Bristol-Myers Squibb (“BMS”) entered into a collaboration and license agreement and various related agreements with BMS (“BMS CLA”).

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

On December 1, 2020, the Company and BMS amended the BMS CLA (“amended BMS CLA”).

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

BMS may until November 30, 2021 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.

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 four-year research term.

On December 1, 2020, the Company and BMS amended the BMS CLA (“amended BMS CLA”) to reduce the scope of the collaboration and license from potentially ten to then four collaboration targets (including a right to replace two of such targets by December 1, 2021).

The Company is eligible to receive research, development, and regulatory milestone payments of up to $ 217.0 million for each of the four collaboration targets if defined milestones are achieved.

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 ending on November 30, 2021, or (B) November 30, 2023, if no replacement targets are designated.

BMS continues to reimburse the Company for these services.

The Company evaluated the impact of the amended BMS CLA in relation to its performance obligation to provide access to BMS to its technology and know-how in the field of gene therapy and to participate in joint steering committee and other governing bodies (“License Revenue”).

The Company determined that its remaining performance obligation under the amended BMS CLA was immaterial and recognized the remaining balance of unrecognized License Revenue as of November 30, 2020.

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.

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 no t generally consider this probable and did not record any License Revenue during the three and nine months ended September 30, 2021.

5 Intangible assets, net and Goodwill

The following table presents the Company’s acquired licenses and acquired IPR&D intangible asset:

September 30,

(in thousands)

Acquired licenses

Less accumulated amortization

Acquired licenses, net

Acquired in-process research and development intangible asset

Intangibles, net

As part of its acquisition of Corlieve as of July 30, 2021, the Company identified certain intangible assets related to an IPR&D intangible asset.

Refer to Note 3 “Corlieve transaction.”

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) November 30, 2023.

BMS reimburses the Company for these services.

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

The Company generated $ 0.4 million collaboration revenue for the three months ended March 31, 2022 ($ 0.5 million for the three months ended March 31, 2021).

Fair value measurement

9 unchanged sentences

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

The following table sets forth the Company’s assets and liabilities that are required to be measured at fair value on a recurring basis as of September 30, 2021, and December 31, 2020:

The following table sets forth the Company’s assets and liabilities that are required to be measured at fair value on a recurring basis as of March 31, 2022, and December 31, 2021:

Quoted prices

3 unchanged sentences

At December 31, 2021

Cash, cash equivalents and restricted cash

Cash and cash equivalents

Restricted cash

Other non-current assets

Derivative financial instruments

Contingent consideration

Derivative financial instrument

Other non-current liabilities

Consideration for post-acquisition services

Other non-current liabilities

Total liabilities

At September 30, 2021

Cash, cash equivalents and restricted cash

At March 31, 2022

Cash and cash equivalents

Restricted cash

Other non-current assets

Contingent consideration

Derivative financial instruments

Current portion of contingent consideration;

contingent consideration, net of current portion

Derivative financial instrument

Other non-current liabilities

2 unchanged sentences

Total liabilities

Derivative financial instruments

The Company issued derivative financial instruments related to its collaboration with BMS.

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

Derivative financial instrument

The Company issued a derivative financial instrument related to its collaboration with BMS.

On December 1, 2020, the Company and BMS agreed that upon the consummation of a change of control transaction of uniQure that occurs prior to December 1, 2026 or BMS’ delivery of a target cessation notice for all four collaboration targets, the Company (or its third party acquirer) shall pay to BMS a one-time, non-refundable, non-creditable cash payment of $ 70.0 million, provided that (x) if $ 70.0 million is greater than five percent ( 5.0 %) of the net proceeds (as contractually defined) from such change of control transaction, the payment shall be an amount equal to five percent of such net proceeds, and (y) if $ 70.0 million is less than one percent of such net proceeds, the change of control payment shall be an amount equal to one percent of such net proceeds (“CoC-payment”).

The Company has not consummated any change of control transaction as of September 30, 2021 that would obligate it to make a CoC-payment.

The Company has not consummated any change of control transaction as of March 31, 2022 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.

1 unchanged sentence

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

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

The Company estimated this unobservable input using the best information available as of September 30, 2021 and December 31, 2020.

The Company estimated this unobservable input using the best information available as of March 31, 2022 and December 31, 2021.

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

Selecting and evaluating market information involves considerable 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 September 30, 2021 and December 31, 2020 was $ 2.6 million.

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 March 31, 2022 was $ 2.1 million and as of December 31, 2021 was $ 2.8 million.

The decrease of the fair value market value of the derivative financial liability of $ 0.7 million for the three months ended March 31, 2022 was recorded as a gain within Other non-operating (losses) / gains ( nil in same period 2021).

Contingent consideration

The Company is required to pay up to EUR 178.8 million ($ 212.4 million) to the former shareholders of Corlieve upon the achievement of contractually defined milestones in connection with the Company’s acquisition of Corlieve (refer to Note 3 “Corlieve transaction” ).

The Company recorded a liability for the fair market value of the contingent consideration of EUR 20.2 million ($ 24.0 million).

The fair market value was determined using unobservable initial inputs with respect to (i) the probability of achieving the relevant milestones, or POS, (ii) the estimated timing of achieving such milestones, and (iii) the interest rate used to discount the payments.

The Company is required to pay up to EUR 178.8 million ($ 198.8 million at March 31, 2022) to the former shareholders of Corlieve upon the achievement of contractually defined milestones in connection with the Company’s acquisition of Corlieve.

The fair market value of the contingent consideration was determined using unobservable initial inputs with respect to (i) the probability of achieving the relevant milestones, or POS, (ii) the estimated timing of achieving such milestones, and (iii) the interest rate used to discount the payments.

The Company determined the fair market value of the contingent consideration by calculating the probability-adjusted payments based on each milestone’s probability of achievement.

The probability-adjusted payments were then discounted to present value using a discount rate representing the Company’s credit risk.

The unobservable inputs were estimated within a range of inputs.

Varying the inputs within the range of inputs considered by the Company would not result in a material change of the fair value of contingent consideration as of September 30, 2021.

Increasing the POS of AMT-260 advancing into clinical development by 5 % would increase the fair value of contingent consideration by $ 1.9 million to $ 25.7 million as of September 30, 2021.

Similarly reducing the estimated timing of achieving such milestones by six months would reduce would increase the fair value of contingent consideration by $ 1.3 million to $ 25.1 million as of September 30, 2021.

The following table presents the changes in fair value of contingent consideration between the July 30, 2021 Acquisition Date and September 30, 2021:

The discount rate was determined using the effective interest rate of the Company’s existing debt facility adjusted for difference in maturity dates based on market data on effective yields for US bonds with a CCC credit rating.

The fair value of the contingent consideration as of March 31, 2022 was $ 31.1 million using discount rates of approximately 10.3 % as well as a 55.0 % likelihood of AMT-260 advancing into clinical development by no later than early 2024.

If as of March 31, 2022 the Company had assumed a 100 % likelihood of AMT-260 advancing into clinical development, then the fair value of the contingent consideration would have increased to $ 51.7 million.

If as of March 31, 2022 the Company assumed that it would discontinue development of the AMT-260 program, then the contingent consideration would be released to income.

Changes in fair value of the contingent consideration are recognized within research and development expenses in the consolidated statements of operations.

The following table presents the changes in fair value of contingent consideration between December 31, 2021 and March 31, 2022:

consideration

(in thousands)

Amount recorded on Acquisition Date

Change in fair value (included within research and development expenses)

Balance at December 31, 2021

Change in fair value (presented within research and development expenses)

Currency translation effects

Balance at September 30, 2021

Balance at March 31, 2022

As of March 31, 2022, the Company classified $ 9.1 million of the total contingent consideration of $ 31.1 million as current liabilities.

The balance sheet classification between current and non-current liabilities is based upon the Company’s best estimate of the timing of settlement of the remaining relevant milestones.

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities include the following items:

September 30,

(in thousands)

Accruals for services provided by vendors-not yet billed

Accruals for goods received from and services provided by vendors-not yet billed

Personnel related accruals and liabilities

Contract liability

Accrued contract fulfillment costs and costs to obtain a contract

6 Long-term debt

On June 14, 2013, the Company entered into a venture debt loan facility with Hercules Capital, Inc.

(formerly known as Hercules Technology Growth Capital, Inc.) (“Hercules”), which was amended and restated on June 26, 2014, and again on May 6, 2016 (“2016 Amended Facility”).

On December 6, 2018, the Company signed an amendment that both refinanced the then-existing $ 20.0 million 2016 Amended Facility and allowed the Company to draw down an additional $ 15.0 million (“2018 Amended Facility”).

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

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

The interest only period was again further extended to June 1, 2023 as a result of the January 2021 amendment (see below).

(formerly known as Hercules Technology Growth Capital, Inc.) (“Hercules”).

The facility was amended and restated in 2014, 2016, 2018 (“2018 Amended Facility”), January 2021 (“2021 Amended Facility”) and in December 2021 (“2021 Restated Facility”).

On January 29, 2021, the Company drew down $ 35.0 million as part of the amendment of the facility at that time.

Pursuant to the 2021 Restated Facility, Tranche A and Tranche B of the 2021 Amended Facility with a total outstanding balance of $ 70.0 million were consolidated into one tranche with a total commitment of $ 100.0 million.

The Company drew down an additional $ 30.0 million at the time of the December 2021 amendment, resulting in total principal outstanding as of March 31, 2022 of $ 100.0 million.

The 2021 Restated Facility extended the loan’s maturity date from June 1, 2023 until December 1, 2025.

The interest-only period was extended from January 1, 2023 to December 1, 2024, or December 1, 2025 if, prior to June 30, 2024, either (a) the Biologics License Application (“BLA”) for AMT-061 is approved by the U.S.

Food and Drug Administration (“FDA”) or (b) AMT-130 is advanced into a pivotal trial.

The interest rate is adjustable and is the greater of (i) 7.95 % and (ii) 7.95 % plus the prime rate less 3.25 % per annum.

Under the 2018 Amended Facility, the Company 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.

On January 29, 2021, the Company and Hercules amended the 2018 Amended Facility (“2021 Amended Facility”).

Pursuant to the 2021 Amended Facility, Hercules agreed to an additional Facility of $ 100.0 million (“Tranche B”), increasing the aggregate principal amount of the term loan facilities from $ 35.0 million to up to $ 135.0 million.

On January 29, 2021, the Company drew down $ 35.0 million of the Tranche B.

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

Advances under Tranche B 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 Tranche B is due on June 1, 2023, which date may be extended by the Company by up to two twelve-month periods.

Advances under Tranche B may now be prepaid without charge as six months have passed since the Company drew down the $ 35.0 million of Tranche B.

The Company owes a back-end fee of 4.85 % of amounts outstanding under Tranche B.

The back-end fee is reduced if prepayment occurs at an earlier date.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2018 Amended Facility and 2021 Amended Facility was $ 71.6 million as of September 30, 2021, compared to $ 35.9 million amortized cost for the 2018 Amended Facility as of December 31, 2020, and is recorded net of discount and debt issuance costs.

The foreign currency loss on the facilities in the three months ended September 30, 2021, was $ 1.8 million and the foreign currency loss on the facilities in the nine months ended September 30, 2021, was $ 4.0 million, compared to a foreign currency gain of $ 1.5 million and $ 1.5 million during the same periods in 2020 for the 2018 Amended Facility.

Interest expense associated with the 2018 Amended Facility and 2021 Amended Facility during the three and nine months ended September 30, 2021, was $ 1.9 million and $ 5.2 million, compared to $ 0.9 million and $ 2.7 million, respectively, during the same periods in 2020 for the 2018 Amended Facility.

As a covenant in the 2018 Amended Facility and 2021 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.

Under the 2021 Restated Facility, the Company owes a back-end fee of 4.85 % of the outstanding debt.

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 Company continues to owe a $ 2.5 million back-end fee related to the 2021 Amended Facility which is due on June 1, 2023.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2021 Restated Facility was $ 102.1 million as of March 31, 2022, compared to $ 101.6 million as of December 31, 2021, and is recorded net of discount and debt issuance costs.

The foreign currency loss on the facility in the three months ended March 31, 2022, was $ 2.1 million compared to a foreign currency loss of $ 3.2 million during the same period in 2021 for the 2018 Amended Facility and 2021 Amended Facility.

Interest expense associated with the 2021 Restated Facility during the three months ended March 31, 2022, was $ 2.4 million compared to $ 1.5 million during the same period in 2021 for the 2018 Amended Facility and 2021 Amended Facility.

As a covenant in the 2021 Restated Facility the Company has periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the United States equivalent to the lesser of (i) 65 % of the outstanding balance of principal due or (ii) 100% of worldwide cash and cash equivalents.

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

In combination with other covenants, the 2018 Amended Facility and 2021 Amended Facility restricts the Company’s ability to, among other things, incur future indebtedness and obtain additional debt financing, to make investments in securities or in other companies, to transfer assets, to perform certain corporate changes, to make loans to employees, officers, and directors, and to make dividend payments and other distributions to its shareholders.

The Company, beginning on April 1, 2023, is also required to keep a minimum of unrestricted cash of at least 50 % of the loan amount outstanding.

If, prior to June 30, 2024, either (a) the BLA for AMT-061 is approved by the FDA or (b) AMT-130 is advanced into a pivotal trial, the minimum cash covenant will be lowered to at least 30 % of the loan amount outstanding and its effectiveness will be deferred to April 1, 2024.

In combination with other covenants, the 2021 Restated Facility restricts the Company’s ability to, among other things, incur future indebtedness and obtain additional debt financing, to make investments in securities or in other companies, to transfer assets, to perform certain corporate changes, to make loans to employees, officers, and directors, and to make dividend payments and other distributions to its shareholders.

The Company secured the facilities by directly or indirectly pledging its total assets of $ 757.2 million, with the exception of $ 101.4 million of cash and cash equivalents and other current assets held by uniQure N.V.

The 2018 Amended Facility and 2021 Amended Facility contain provisions that include the occurrence of a material adverse effect, as defined therein, which would entitle Hercules to declare all principal, interest and other amounts owed by the Company immediately due and payable.

As of September 30, 2021, the Company was in material compliance with all covenants and provisions.

9 Shareholders’ equity

On March 1, 2021, the Company entered into a Sales Agreement with SVB Leerink LLC (“SVB Leerink”) with respect to an at-the-market (“ATM”) offering program, under which the Company may, from time to time in its sole discretion, offer and sell through SVB Leerink, acting as agent, its ordinary shares, up to an aggregate offering price of $ 200.0 million.

The Company will pay SVB Leerink a commission equal to 3 % of the gross proceeds of the sales price of all ordinary shares sold through it as sales agent under the Sales Agreement.

In March and April 2021, the Company issued an aggregate of 921,730 ordinary shares at a weighted average price of $ 33.52 per share, with net proceeds of $ 29.6 million, after deducting underwriting discounts and net of offering expenses.

The Company defers direct, incremental costs associated to this offering, except for the commission costs to SVB Leerink, which are a reduction to additional paid-in capital, and will deduct these costs from additional paid-in capital in the consolidated balance sheets proportionately to the amount of proceeds raised.

During the three and nine months ended September 30, 2021, nil and $ 1.3 million, respectively, of direct, incremental costs were deducted from additional paid-in capital.

Following the Closing of the CSL Behring transaction, the Company released and consumed its prior year net operating tax losses carry forward for the years 2011 to 2018.

The Company allocated a part of the release to the tax benefit of share issuance costs incurred in 2014, 2015, 2017 and 2018.

This resulted in an increase of additional paid-in capital of nil and $ 3.0 million in the three and nine months ended September 30, 2021, respectively.

The 2021 Restated 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 March 31, 2022, the Company was in material compliance with all covenants and provisions.

7 Share-based compensation

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”).

At the annual general meeting of shareholders in June 2021, the Company’s shareholders approved an increase in the number of shares authorized for issuance under the 2014 Plan from 8,601,471 to 12,601,471 .

At the annual general meeting of shareholders in June 2021, the Company’s shareholders approved an increase in the number of ordinary shares authorized for issuance under the 2014 Plan from 8,601,471 to 12,601,471 .

a) 2014 Plans

Share-based compensation expense recognized by classification included in the Consolidated statements of operations and comprehensive loss in relation to the 2014 Plans for the periods indicated below was as follows:

Three months ended September 30,

Nine months ended September 30,

(in thousands)

Three months ended March 31,

(in thousands)

2 unchanged sentences

Share-based compensation expense recognized by award type was as follows:

Three months ended September 30,

Nine months ended September 30,

(in thousands)

Three months ended March 31,

(in thousands)

2 unchanged sentences

Performance share units

As of September 30, 2021, the unrecognized share-based compensation expense related to unvested awards under the 2014 Plans were:

As of March 31, 2022, the unrecognized share-based compensation expense related to unvested awards under the 2014 Plans were:

Weighted average

9 unchanged sentences

Any options that vest must be exercised by the tenth anniversary of the initial grant date.

The following tables summarize option activity under the Company’s 2014 Plans for the nine months ended September 30, 2021:

The following tables summarize option activity under the Company’s 2014 Plans for the three months ended March 31, 2022:

Weighted average

2 unchanged sentences

Outstanding at December 31, 2021

Outstanding at September 30, 2021

Thereof, fully vested and exercisable at September 30, 2021

Thereof, outstanding and expected to vest after September 30, 2021

Outstanding at March 31, 2022

Thereof, fully vested and exercisable on March 31, 2022

Thereof, outstanding and expected to vest after March 31, 2022

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

1 unchanged sentence

The fair value of each option issued is estimated at the respective grant date using the Hull & White option pricing model with the following weighted-average assumptions:

Three months ended September 30,

Nine months ended September 30,

Three months ended March 31,

Expected volatility

2 unchanged sentences

1.21 - 1.71 %

0.76 % - 1.44 %

Expected dividend yield

Restricted share units (“RSUs”)

The following table summarizes the RSUs activity for the nine months ended September 30, 2021:

The following table summarizes the RSUs activity for the three months ended March 31, 2022:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2021

Non-vested at September 30, 2021

Non-vested at March 31, 2022

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

2 unchanged sentences

Performance share units (“PSUs”)

The following table summarizes the PSUs activity for the nine months ended September 30, 2021:

The following table summarizes the PSUs activity for the three months ended March 31, 2022:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2021

Non-vested at September 30, 2021

The PSUs granted in 2019 vest on the third anniversary of the grant, subject to the grantee’s continued employment.

The Company granted shares to certain employees in September 2021 that will be earned upon the later of one year of service period or the achievement of certain defined milestones, subject to the grantee’s continued employment.

The Company recognized the compensation cost related to these grants to the extent it considers achievement of the milestones to be probable.

Non-vested at March 31, 2022

PSUs granted in 2019 vested on the third anniversary of the grant, subject to the grantee’s continued employment.

The Company granted shares to certain employees in September and December 2021 that will be earned upon achievement of defined milestones.

Earned shares will vest upon the later of a minimum service period of one year or three years , or the achievement of defined milestones, subject to the grantee’s continued employment.

In addition, portions of the December 2021 shares granted to executives and other members of senior management are subject to achieving a minimum total shareholder return relative to the Nasdaq biotechnology index.

The Company recognizes the compensation cost related to these grants to the extent it considers achievement of the milestones to be probable.

b) Employee share purchase plan (“ESPP”)

3 unchanged sentences

The purchase price of the ordinary shares on each purchase date is equal to 85 % of the lower of the closing market price on the offering date and the closing market price on the purchase date of each three-month offering period.

During the nine months ended September 30, 2021, 4,724 ordinary shares were issued under the ESPP compared to 3,282 during the same period in 2020.

As of September 30, 2021, a total of 127,302 ordinary shares remain available for issuance under the ESPP plan compared to a total of 134,925 as of September 30, 2020.

Other income during the three and nine months ended September 30, 2021, was $ 1.7 million and $ 9.6 million, respectively, compared to $ 1.0 million and $ 2.6 million during the same periods in 2020.

Other income in 2020 and 2021 includes income from payments received from European authorities to subsidize the Company’s research and development efforts in the Netherlands as well as income from subleasing part of the Amsterdam facility.

In addition, other income includes $ 1.3 million and $ 2.6 million of employee retention credits received under the U.S.

Coronavirus Aid, Relief, and Economic Security Act, during the three and nine months ended September 30, 2021, respectively.

Additionally, $ 3.0 million related to the acquisition by the Company of 69,899 shares of VectorY B.V.

in conjunction with a settlement agreement that the Company and VectorY B.V.

entered into in April 2021.

This $ 3.0 million was recorded in other income for the nine months ended September 30, 2021 ( nil for three months ended September 30, 2021).

No such income was recorded in 2020.

The Company recorded $ 0.1 million in income tax expense in the three months ended September 30, 2021, and $ 3.6 million in the nine months ended September 30, 2021.

The Company recorded no income tax expense during the same periods in 2020.

As of December 31, 2020, the Company had recorded a full valuation allowance against its Dutch net deferred tax assets.

On May 6, 2021, the CSL Behring Agreement became effective (refer to Note 4 “Collaboration arrangements and concentration of credit risk” ).

The Company recorded $ 462.4 million of license revenue related to closing the transaction.

The Company intends to record such revenue in its Dutch tax return related to the 12-month period ended December 31, 2020.

As such, the Company expects to file a return showing a taxable profit in the Netherlands in 2020, which would result in the consumption of substantially all of its Dutch net operating losses for the years 2011 to 2018.

The Company’s remaining Dutch net operating tax losses carried forward would relate to 2019.

The Dutch government on June 4, 2021 enacted legislation, whereby such net operating tax losses can be carried forward indefinitely.

The Company expects to continue incurring tax losses for the foreseeable future including 2021.

As such, the Company retained its full valuation allowance related to the net deferred assets as of September 30, 2021.

The adjustment to the Company’s 2020 filing position resulting in the release and consumption of prior year net operating tax losses carried forward was treated as a discrete event in the nine months ended September 30, 2021.

The Company allocated part of the release to the tax benefit of share issuance cost incurred in 2014, 2015, 2017 and 2018.

This resulted in an increase of additional paid-in capital as well as deferred tax expenses of $ 3.0 million.

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

The Company recorded $ 0.2 million and $ 0.7 million deferred tax expense in relation to its operations in the United States during the three and nine months ended September 30, 2021, respectively.

The Company recorded a nil net deferred tax expense in the prior year as it had recorded a valuation allowance against its net deferred tax assets in the United States as of September 30, 2020.

In connection with the Corlieve acquisition, the Company recognized a deferred tax liability related to acquired identifiable intangible assets net of net operating tax losses carried forward of EUR 11.5 million ($ 13.6 million) as of the Acquisition Date.

The Company recorded deferred tax income of $ 0.2 million related to reduction of the net deferred tax liability between the Acquisition Date and September 30, 2021 as a result of incurring net operating losses in France.

The effective income tax rates of 0.2 % and - 1.1 % during the three and nine months ended September 30, 2021, respectively, are substantially lower than the enacted rate of 25 % in the Netherlands.

This is a result of the Company recording a valuation allowance against its remaining net deferred tax assets in the Netherlands as of December 31, 2020 and September 30, 2021.

During the three months ended March 31, 2022, 3,558 ordinary shares were issued under the ESPP compared to 1,174 during the same period in 2021.

As of March 31, 2022, a total of 123,744 ordinary shares remain available for issuance under the ESPP plan compared to a total of 130,852 as of March 31, 2021.

The Company recorded $ 0.6 million deferred tax benefit in relation to its operations in the United States, France and Switzerland during the three-month period ended March 31, 2022.

The Company recorded $ 0.2 million net deferred tax expense in the prior year in the United States as of March 31, 2021.

The effective income tax rate of ( 1.3 )% during the three months ended March 31, 2022 is substantially lower than the enacted rated of 25.8 % in the Netherlands as the Company recorded a valuation allowance against its net deferred tax assets in the Netherlands.

The effective income tax rate during the three months ended March 31, 2021 was 0.5 % as the Company had recorded a valuation allowance against all its net deferred tax assets in the Netherlands.

9 Basic and diluted earnings per share

Basic net (loss) / income per ordinary share is computed by dividing net (loss) / income for the period by the weighted average number of ordinary shares outstanding during the period.

Diluted earnings per ordinary share are calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potentially dilutive ordinary shares.

For the three months and nine months ended September 30, 2021, dilutive net (loss) / income per ordinary share is computed using the treasury method.

The following table provides the calculation of basic and diluted earnings per ordinary share:

Three months ended September 30,

Nine months ended September 30,

(in thousands)

Net (loss) / income attributable to ordinary shares

Weighted-average number of ordinary shares outstanding - basic

Stock options under 2014 Plans and previous plan

Non-vested RSUs and PSUs

Employee share purchase plan

Weighted-average number of ordinary shares outstanding - diluted

The following table presents ordinary share equivalents that were excluded from the calculation of diluted net (loss) / income per ordinary share for the three and nine months ended September 30, 2021 and 2020 as the effect of their inclusion would have been anti-dilutive.

Three months ended September 30,

Nine months ended September 30,

(in thousands)

Anti-dilutive ordinary share equivalents

Diluted earnings per share are calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potentially dilutive ordinary shares.

As the Company has incurred a loss, 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 March 31, 2022 and March 31, 2021, respectively.

The potentially dilutive ordinary shares are summarized below:

(ordinary shares)

Stock options under 2014 Plans and previous plan

1 unchanged sentence

Employee share purchase plan

BMS warrants (derecognized as of December 1, 2020 - refer to Note 6, "Fair value measurement"

Total anti-dilutive ordinary share equivalents

The anti-dilutive ordinary shares are presented without giving effect to the application of the treasury method or exercise prices that exceeded the price of the Company’s ordinary shares as of September 30, 2020.

In addition, the BMS warrants were not exercisable as of September 30, 2020.

This would 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.

Total potential dilutive ordinary shares

10 Subsequent events

On October 21, 2021, the Company held an Extraordinary General Meeting of its shareholders and Rachelle Jacques was appointed to the Board of Directors (the “Board”).

Jacques will also serve as a member of the Audit Committee of the Board effective as of October 21, 2021.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements