What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2022-08-08 compared with 2022-05-02 · 163 added, 92 removed, 294 unchanged (46% of the section changed)

9 unchanged sentences

Non-current assets

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.

Property, plant and equipment, net of accumulated depreciation of $ 39.4 million as of June 30, 2022 and $ 36.9 million as of December 31, 2021

Operating lease right-of-use assets

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

Intangible assets, net, including an in-process research and development asset of $ 56.0 million as of June 30, 2022 and $ 60.8 million as of December 31, 2021

Deferred tax assets, net

9 unchanged sentences

Long-term debt

Operating lease liabilities, net of current portion

Contingent consideration, net of current portion

Operating lease liabilities, net of current portion

Deferred tax liability, net

5 unchanged sentences

Ordinary shares, € 0.05 par value:

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

80,000,000 shares authorized as of June 30, 2022 and December 31, 2021 and 46,684,583 and 46,298,635 ordinary shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

Additional paid-in-capital

6 unchanged sentences

COMPREHENSIVE LOSS

Three months ended March 31,

Three months ended June 30,

Six months ended June 30,

(in thousands, except share and per share amounts)

License revenues

Collaboration revenues

1 unchanged sentence

Operating expenses:

Cost of contract revenues

Cost of contract manufacturing

Research and development expenses

2 unchanged sentences

Other expense

Loss from operations

(Loss) / income from operations

Interest income

1 unchanged sentence

Foreign currency gains, net

Other non-operating gains, net

Loss before income tax benefit / (expense)

Other non-operating (losses) / gains, net

(Loss) / income before income tax benefit / (expense)

Income tax benefit / (expense)

Net (loss) / income

Other comprehensive loss:

Foreign currency translation adjustments

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

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

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 MARCH 31

FOR THE THREE-MONTH PERIOD ENDED JUNE 30, 2022 AND 2021

Ordinary shares

3 unchanged sentences

(in thousands, except share and per share amounts)

Balance at December 31, 2020

Loss for the period

Balance at March 31, 2021

Income for the period

Other comprehensive loss

Issuance of ordinary shares

Income tax benefit of past share issuance cost

Exercise of share options

1 unchanged sentence

Share-based compensation expense

Issuance of ordinary shares relating to employee stock purchase plan

Balance at June 30, 2021

Balance at March 31, 2022

Loss for the period

Other comprehensive loss

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 June 30, 2022

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

UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

FOR THE SIX-MONTH PERIOD ENDED JUNE 30, 2022 AND 2021

Ordinary shares

comprehensive

shareholders’

income / (loss)

(in thousands, except share and per share amounts)

Balance at December 31, 2020

Income for the period

Other comprehensive loss

Issuance of ordinary shares

Income tax benefit of past share issuance cost

Exercises 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 June 30, 2021

Balance at December 31, 2021

Loss for the period

1 unchanged sentence

Exercise of share options

Restricted share units and performance share units distributed during the period

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 March 31, 2022

Balance at June 30, 2022

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

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

Three months ended March 31,

Six months ended June 30,

(in thousands)

Cash flows from operating activities

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

Net (loss) / income

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

Depreciation and amortization expense

3 unchanged sentences

Unrealized foreign exchange gains, net

Other non-cash items, net

Changes in operating assets and liabilities:

2 unchanged sentences

Accrued expenses, other liabilities, and operating leases

Net cash used in operating activities

Net cash (used in) / generated from operating activities

Cash flows from investing activities

4 unchanged sentences

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

Proceeds from loan increment, net of debt issuance costs

Proceeds from issuance of ordinary shares

Share issuance costs from issuance of ordinary shares

Proceeds from loan increment, net of debt issuance costs

Net cash generated from financing activities

36 unchanged sentences

GAAP have been omitted.

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 results of operations for the three and six months ended June 30, 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 .

5 unchanged sentences

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.

There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2022, except as noted below.

The Company started producing commercial materials in April 2022 to supply CSL Behring LLC (“CSL Behring”) with etranacogene dezaparvovec (the “Product”) in accordance with the June 2020 Development and Commercial Supply Agreement between the Company and CSL Behring.

From this date onwards, the Company presents the costs associated with the aforementioned activities as cost of contract manufacturing.

The Company capitalizes inventory to be sold to CSL Behring to the extent it expects to generate probable future benefits from such sales.

Refer to Note 3, “CSL Behring collaboration” for further detail.

Per ASC 330, Inventory, inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out basis.

The Company uses standard costs, approximating average costs to determine its cost basis for inventories.

The Company’s assessment of market value requires the use of estimates regarding the net realizable value of its inventory balances, including an assessment of excess or obsolete inventory.

As applicable, write-downs resulting from adjustments to net realizable value will be recorded to cost of contract manufacturing.

2.5 Recent accounting pronouncements

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

There have been no new accounting pronouncements or changes to accounting pronouncements during the six months ended June 30, 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.

CSL Behring collaboration

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 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, pursuant to which CSL Behring received exclusive global rights to etranacogene dezaparvovec, the Company’s investigational gene therapy for patients with hemophilia B.

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”).

1 unchanged sentence

(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”).

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

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” that are included as part of 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.

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.

4 unchanged sentences

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

The Company recognized $ 462.4 million of license revenue in the three and six months ended June 30, 2021 related to the License Sale.

During the three and six months ended June 30, 2022, the Company did no t recognize any license revenue.

The Company recognized nil and $ 1.4 million of collaboration revenue in the three and six months ended June 30, 2022, compared to $ 0.4 million in the three and six months ended June 30, 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.

1 unchanged sentence

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”).

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) 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).

In March and April 2022, CSL Behring submitted marketing applications in the United States and European Union, and as of June 30, 2022, the Company had collected the $ 55.0 million owed.

As of June 30, 2022, the Company had accounts receivable of $ 2.7 million from CSL Behring.

The Company commenced capitalizing inventory in April 2022 for the Product to be sold to CSL Behring.

The inventory balance consisted of $ 2.0 million of work in progress and $ 1.0 million of raw materials as of June 30, 2022.

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 March 31, 2022, and December 31, 2021:

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 June 30, 2022, and December 31, 2021:

Quoted prices

14 unchanged sentences

Total liabilities

At March 31, 2022

At June 30, 2022

Cash and cash equivalents

13 unchanged sentences

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 March 31, 2022 that would obligate it to make a CoC-payment.

The Company has not consummated any change of control transaction as of June 30, 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.

3 unchanged sentences

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 March 31, 2022 and December 31, 2021.

The Company estimated this unobservable input using the best information available as of June 30, 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 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).

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 June 30, 2022 was $ 2.2 million and as of December 31, 2021 was $ 2.8 million.

The increase of the fair market value of the derivative financial liability of $ 0.1 million for the three month period ended June 30, 2022 was recorded as a loss and the decrease of the fair market value of $ 0.6 million for the six months ended June 30, 2022 was recorded as a gain within Other non-operating (losses) / gains ( nil in the same periods in 2021).

Contingent consideration

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 Company is required to pay up to EUR 178.8 million ($ 186.9 million) at June 30, 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.

2 unchanged sentences

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.

The fair value of the contingent consideration as of June 30, 2022 was $ 29.1 million (December 31, 2021:

$ 29.5 million) using discount rates of approximately 11.3 % to 11.7 % (December 31, 2021:

10.9 % to 11.9 %) as well as a 55.0 % (December 31, 2021:

55.0 %) likelihood of AMT-260 advancing into clinical development by no later than early 2024.

If as of June 30, 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 $ 46.1 million.

If as of June 30, 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:

The following table presents the changes in fair value of contingent consideration between December 31, 2021 and June 30, 2022:

consideration

3 unchanged sentences

Currency translation effects

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.

Balance at June 30, 2022

As of June 30, 2022, the Company classified $ 8.7 million of the total contingent consideration of $ 29.1 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.

11 unchanged sentences

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 Company drew down an additional $ 30.0 million at the time of the December 2021 amendment, resulting in total principal outstanding as of June 30, 2022 of $ 100.0 million.

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

5 unchanged sentences

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.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2021 Restated Facility was $ 102.6 million as of June 30, 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 and six months ended June 30, 2022 was $ 6.3 million and $ 8.4 million, respectively compared to a foreign currency gain of $ 0.9 million and loss of $ 2.2 million during the same periods in 2021 for the 2018 Amended Facility and the 2021 Amended Facility.

Interest expense associated with the 2021 Restated Facility during the three and six months ended June 30, 2022 was $ 2.6 million and $ 5.0 million, respectively compared to $ 1.8 million and $ 3.4 million, respectively, during the same periods in 2021 for the 2018 Amended Facility and the 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.

4 unchanged sentences

The Company secured the facilities by directly or indirectly pledging its total assets of $ 701.2 million, with the exception of $ 89.2 million of cash and cash equivalents and other current assets held by uniQure N.V.

and $ 85.1 million of other current assets and investment held by Corlieve Therapeutics SAS.

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.

As of June 30, 2022, the Company was in material compliance with all covenants and provisions.

7 Share-based compensation

1 unchanged sentence

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 March 31,

In June 2018, the Company’s shareholders adopted and approved an employee share purchase plan (“ESPP”) allowing the Company to issue up to 150,000 ordinary shares.

The ESPP is intended to qualify under Section 423 of the Internal Revenue Code of 1986.

Under the ESPP, employees are eligible to purchase ordinary shares through payroll deductions, subject to any plan limitations.

The purchase price of the 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.

2014 Plans and ESPP

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

Three months ended June 30,

Six months ended June 30,

(in thousands)

Research and development

Selling, general and administrative

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

Three months ended March 31,

Cost of contract manufacturing

Share-based compensation expense recognized by award type of the 2014 Plans as well as the ESPP was as follows:

Three months ended June 30,

Six months ended June 30,

(in thousands)

Award type/ESPP

Share options

1 unchanged sentence

Performance share units

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

As of June 30, 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 three months ended March 31, 2022:

The following tables summarize option activity under the Company’s 2014 Plans for the six months ended June 30, 2022:

Weighted average

2 unchanged sentences

Outstanding at December 31, 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

Outstanding at June 30, 2022

Thereof, fully vested and exercisable on June 30, 2022

Thereof, outstanding and expected to vest after June 30, 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 March 31,

Three months ended June 30,

Six months ended June 30,

Expected volatility

2 unchanged sentences

3.03 % - 3.44 %

1.72 - 1.85 %

2.12 % - 3.44 %

1.21 - 1.85 %

Expected dividend yield

Restricted share units (“RSUs”)

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

The following table summarizes the RSUs activity for the six months ended June 30, 2022:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2021

Non-vested at March 31, 2022

Non-vested at June 30, 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 three months ended March 31, 2022:

The following table summarizes the PSUs activity for the six months ended June 30, 2022:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2021

Non-vested at March 31, 2022

Non-vested at June 30, 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.

The Company granted shares to certain employees in September and December 2021 and at various dates during the six months ended June 30, 2022 that will be earned upon achievement of defined milestones.

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

1 unchanged sentence

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”)

In June 2018, the Company’s shareholders adopted and approved an ESPP allowing the Company to issue up to 150,000 ordinary shares.

The ESPP is intended to qualify under Section 423 of the Internal Revenue Code of 1986.

Under the ESPP, employees are eligible to purchase ordinary shares through payroll deductions, subject to any plan limitations.

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.

During the six months ended June 30, 2022, 5,890 ordinary shares were issued under the ESPP compared to 1,174 during the same period in 2021.

As of June 30, 2022, a total of 121,414 ordinary shares remain available for issuance under the ESPP plan compared to a total of 130,852 as of June 30, 2021.

The Company recorded $ 0.3 and $ 0.9 million deferred tax benefit in relation to its operations in the United States and France during the three and six months ended June 30, 2022, respectively.

The Company recorded $ 3.3 million and $ 3.5 million in deferred income tax expense in the prior year in the United States and the Netherlands for the three and six months ended June 30, 2021, respectively, of which $ 3.0 million in the three and six months periods related to the Netherlands.

The effective income tax rate of - 0.8 % and - 1.1 % during the three and six months ended June 30, 2022 is substantially lower than the enacted rated of 25.8 % in the Netherlands as the Company records a valuation allowance against its net deferred tax assets in the Netherlands.

The effective income tax rate during the three and six months ended June 30, 2021 was - 0.8 % and - 1.0 %, respectively, 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

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.

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 and six months ended June 30, 2021, dilutive net income per ordinary share is computed using the treasury method.

As the Company has incurred a loss in the three and six months ended June 30, 2022, all potentially dilutive ordinary shares for these periods would have an antidilutive effect, if converted, and thus have been excluded from the computation of loss per share for the three and six months ended June 30, 2022.

The potentially dilutive ordinary shares are summarized below:

(ordinary shares)

Three months ended June 30,

Six months ended June 30,

(in thousands, except

share amounts)

(in thousands, except

share amounts)

Net (loss) / income attributable to ordinary shares

Weighted-average number of ordinary shares outstanding - basic

Stock options under 2014 Plans and previous plan

1 unchanged sentence

Employee share purchase plan

Total potential dilutive ordinary shares

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 six months ended June 30, 2022 and 2021 as the effect of their inclusion would have been anti-dilutive:

Three months ended June 30,

Six months ended June 30,

Anti-dilutive ordinary share equivalents

Stock options under 2014 Plans and previous plan

Non-vested RSUs and PSUs

Employee share purchase plan

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 the three and six months ended June 30, 2022.

10 Subsequent events

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