What changed in this filing

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Item 1. Financial Statements

2022-11-02 compared with 2022-08-08 · 110 added, 98 removed, 359 unchanged (37% of the section changed)

1 unchanged sentence

UNAUDITED CONSOLIDATED BALANCE SHEETS

September 30,

(in thousands, except share and per share amounts)

6 unchanged sentences

Non-current assets

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

Property, plant and equipment, net of accumulated depreciation of $ 40.5 million as of September 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 $ 56.0 million as of June 30, 2022 and $ 60.8 million as of December 31, 2021

Intangible assets, net, including an in-process research and development asset of $ 52.5 million as of September 30, 2022 and $ 60.8 million as of December 31, 2021

Deferred tax assets, net

9 unchanged sentences

Long-term debt

Contingent consideration, net of current portion

Operating lease liabilities, net of current portion

Contingent consideration, net of current portion

Deferred tax liability, net

5 unchanged sentences

Ordinary shares, € 0.05 par value:

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

80,000,000 shares authorized as of September 30, 2022 and December 31, 2021 and 46,815,109 and 46,298,635 ordinary shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively

Additional paid-in-capital

5 unchanged sentences

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND

COMPREHENSIVE LOSS

Three months ended June 30,

Six months ended June 30,

COMPREHENSIVE (LOSS) INCOME

Three months ended September 30,

Nine months ended September 30,

(in thousands, except share and per share amounts)

29 unchanged sentences

UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

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

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

Ordinary shares

1 unchanged sentence

shareholders’

income / (loss)

(in thousands, except share and per share amounts)

Balance at March 31, 2021

Income for the period

Balance at June 30, 2021

Loss 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 September 30, 2021

Balance at June 30, 2022

Balance at March 31, 2022

Loss for the period

1 unchanged sentence

Exercise of share options

Restricted 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 June 30, 2022

Balance at September 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

FOR THE NINE-MONTH PERIOD ENDED SEPTEMBER 30, 2022 AND 2021

Ordinary shares

12 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at June 30, 2021

Balance at September 30, 2021

Balance at December 31, 2021

5 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at June 30, 2022

Balance at September 30, 2022

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

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six months ended June 30,

Nine months ended September 30,

(in thousands)

7 unchanged sentences

Unrealized foreign exchange gains, net

Other non-cash items, net

Other non-current assets, net

Changes in operating assets and liabilities:

5 unchanged sentences

Purchases of property, plant, and equipment

Acquisition of remaining outstanding ordinary shares related to Corlieve acquisition

Acquisition of Corlieve, net of cash acquired

Net cash used in investing activities

4 unchanged sentences

Share issuance costs from issuance of ordinary shares

Repayment of debt acquired through acquisition of Corlieve

Net cash generated from financing activities

36 unchanged sentences

GAAP have been omitted.

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 results of operations for the three and nine months ended September 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 six months ended June 30, 2022, except as noted below.

There have been no material changes in the Company’s significant accounting policies during the nine months ended September 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.

3 unchanged sentences

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.

The Company capitalizes raw materials to the extent these can be used in the manufacturing of the Product.

The Company uses standard costs, approximating average costs to determine its cost basis for work in progress and finished goods.

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

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 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.

There have been no new accounting pronouncements or changes to accounting pronouncements during the nine months ended September 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

1 unchanged sentence

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:

The Company, as of the effective date, identified two material performance obligations related to the CSL Behring Agreement:

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

10 unchanged sentences

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 recognized nil and $ 462.4 million of license revenue in the three and nine months ended September 30, 2021 related to the License Sale.

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

Collaboration Services

The Company recognized $ 0.7 million and $ 2.1 million of collaboration revenue in the three and nine months ended September 30, 2022, compared to $ 0.5 and $ 0.9 million in the three and nine months ended September 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.

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 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.

Contract Manufacturing

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.

On September 6, 2022, CSL Behring notified the Company of its intent to transfer manufacturing technology related to the Product to a third-party contract manufacturer designated by CSL Behring.

CSL Behring also requested that the Company continue to serve as a manufacturer of the Product after the Company completes the technology transfer to a third party.

The Company and CSL Behring are in the process of negotiating the terms of the transfer of manufacturing responsibility pursuant to the CSL Behring Agreement.

Accounts Receivable and Contract Asset

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

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

As of September 30, 2022, the Company had accounts receivable of $ 3.0 million from CSL Behring.

The Company commenced capitalizing inventory in April 2022 when the Company started producing commercial materials to supply the Product to CSL Behring.

The following table summarizes the inventory balances for the nine months ended September 30, 2022:

September 30,

(in thousands)

Raw materials

Work in progress

Finished goods

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 June 30, 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 September 30, 2022, and December 31, 2021:

Quoted prices

14 unchanged sentences

Total liabilities

At June 30, 2022

At September 30, 2022

Cash and cash equivalents

10 unchanged sentences

Total liabilities

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 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.

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

This probability represents an unobservable input.

The Company 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 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 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 ($ 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 Company is required to pay up to EUR 178.8 million ($ 175.2 million) at September 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 June 30, 2022 was $ 29.1 million (December 31, 2021:

The fair value of the contingent consideration as of September 30, 2022 was $ 32.7 million (December 31, 2021:

$ 29.5 million) using discount rates of approximately 11.9 % to 13.3 % (December 31, 2021:

10.9 % to 11.9 %) as well as a 66.0 % (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.

55.0 %) likelihood of Corlieve’s target candidate for treatment of temporal lobe epilepsy (“AMT-260”) advancing into clinical development by no later than late 2023.

If as of September 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 $ 45.4 million.

If as of September 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 June 30, 2022:

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

consideration

3 unchanged sentences

Currency translation effects

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.

Balance at September 30, 2022

As of September 30, 2022, the Company classified $ 23.5 million of the total contingent consideration of $ 32.7 million as current liabilities.

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

Derivative financial instrument

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

The Company has not consummated any change of control transaction as of September 30, 2022 that would obligate it to make a CoC-payment.

This probability represents an unobservable input.

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

The Company estimated this unobservable input using the best information available as of September 30, 2022 and December 31, 2021.

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

The change in the fair market value of the derivative financial liability was nil for the three months ended September 30, 2022 and was $ 0.6 million for the nine months ended September 30, 2022 related to a decrease in the fair market value ( nil in the same periods in 2021).

The decrease in fair market value for the nine months ended September 30, 2022 was recorded as a gain within Other non-operating (losses) / gains .

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities include the following items:

September 30,

(in thousands)

8 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 June 30, 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 September 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 $ 102.6 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.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2021 Restated Facility was $ 103.3 million as of September 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 nine months ended September 30, 2022 was $ 6.6 million and $ 15.0 million, respectively compared to a foreign currency loss of $ 1.8 million and $ 4.0 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 nine months ended September 30, 2022 was $ 3.0 million and $ 8.1 million, respectively compared to $ 1.9 million and $ 5.2 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.

3 unchanged sentences

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 $ 701.2 million, with the exception of $ 89.2 million of cash and cash equivalents and other current assets held by uniQure N.V.

The Company secured the facilities by directly or indirectly pledging its total assets of $ 638.2 million, less $ 75.3 million of cash and cash equivalents and other current assets held by uniQure N.V.

and $ 80.2 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 June 30, 2022, the Company was in material compliance with all covenants and provisions.

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

8 Share-based compensation

7 unchanged sentences

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,

Three months ended September 30,

Nine months ended September 30,

(in thousands)

4 unchanged sentences

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,

Three months ended September 30,

Nine months ended September 30,

(in thousands)

4 unchanged sentences

Performance share units

As of June 30, 2022, the unrecognized share-based compensation expense related to unvested awards under the 2014 Plans were:

As of September 30, 2022, the unrecognized share-based compensation expense related to unvested awards under the 2014 Plans were:

Weighted average

2 unchanged sentences

Restricted share units

Performance share units

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

4 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 six months ended June 30, 2022:

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

Weighted average

2 unchanged sentences

Outstanding at December 31, 2021

Outstanding at June 30, 2022

Thereof, fully vested and exercisable on June 30, 2022

Thereof, outstanding and expected to vest after June 30, 2022

Outstanding at September 30, 2022

Thereof, fully vested and exercisable on September 30, 2022

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

Six months ended June 30,

Three months ended September 30,

Nine months ended September 30,

Expected volatility

3 unchanged sentences

1.21 - 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 six months ended June 30, 2022:

The following table summarizes the RSUs activity for the nine months ended September 30, 2022:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2021

Non-vested at June 30, 2022

Non-vested at September 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 six months ended June 30, 2022:

The following table summarizes the PSUs activity for the nine months ended September 30, 2022:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2021

Non-vested at June 30, 2022

Non-vested at September 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 and at various dates during the six months ended June 30, 2022 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 nine months ended September 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.

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.

During the nine months ended September 30, 2022, 9,305 ordinary shares were issued under the ESPP compared to 4,724 during the same period in 2021.

As of September 30, 2022, a total of 117,997 ordinary shares remain available for issuance under the ESPP plan compared to a total of 127,302 as of September 30, 2021.

The Company recorded $ 0.3 and $ 1.3 million deferred tax benefit in relation to its operations in the United States and France during the three and nine months ended September 30, 2022, respectively.

The Company recorded $ 0.1 million and $ 3.6 million in deferred income tax expense in the prior year in the United States and the Netherlands for the three and nine months ended September 30, 2021, respectively, of which nil and $ 3.0 million in the three and nine months periods related to the Netherlands, respectively.

The effective income tax rate of - 0.7 % and - 0.9 % during the three and nine months ended September 30, 2022 is substantially lower than the enacted rate 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 nine months ended September 30, 2021 was 0.2 % and - 1.1 %, respectively, as the Company had recorded a valuation allowance against all its net deferred tax assets in the Netherlands.

10 Basic and diluted earnings per share

1 unchanged sentence

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.

For the three and nine months ended September 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 nine months ended September 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 nine months ended September 30, 2022.

The potentially dilutive ordinary shares are summarized below:

Three months ended June 30,

Six months ended June 30,

Three months ended September 30,

Nine months ended September 30,

(in thousands, except

8 unchanged sentences

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,

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, 2022 and 2021 as the effect of their inclusion would have been anti-dilutive:

Three months ended September 30,

Nine months ended September 30,

Anti-dilutive ordinary share equivalents

3 unchanged sentences

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.

11 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