What changed in this filing

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Item 1. Financial Statements

2023-08-01 compared with 2023-05-09 · 173 added, 79 removed, 285 unchanged (47% of the section changed)

10 unchanged sentences

Non-current assets

Property, plant and equipment, net of accumulated depreciation of $ 46.9 million as of March 31, 2023 and $ 44.1 million as of December 31, 2022

Property, plant and equipment, net of accumulated depreciation of $ 49.4 million as of June 30, 2023 and $ 44.1 million as of December 31, 2022

Non-current investment securities

Operating lease right-of-use assets

Intangible assets, net, including an in-process research and development asset of $ 58.3 million as of March 31, 2023 and $ 57.3 million as of December 31, 2022

Intangible assets, net, including in-process research and development asset of $ 58.3 million as of June 30, 2023 and $ 57.3 million as of December 31, 2022

Deferred tax assets, net

9 unchanged sentences

Long-term debt

Liability from royalty financing agreement

Operating lease liabilities, net of current portion

7 unchanged sentences

Ordinary shares, € 0.05 par value:

80,000,000 shares authorized as of March 31, 2023 and December 31, 2022 and 47,546,673 and 46,968,032 ordinary shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively

80,000,000 shares authorized as of June 30, 2023 and December 31, 2022 and 47,702,331 and 46,968,032 ordinary shares issued and outstanding as of June 30, 2023 and December 31, 2022, 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

Contract manufacturing revenues

10 unchanged sentences

Interest expense

Foreign currency (losses) / gains, net

Foreign currency gains / (losses), net

Other non-operating gains, net

Loss before income tax benefit

Income tax benefit

Income tax (expense )/ benefit

Other comprehensive loss:

5 unchanged sentences

UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022

FOR THE THREE MONTHS ENDED JUNE 30, 2023 AND 2022

Ordinary shares

1 unchanged sentence

shareholders’

(loss) / income

income / (loss)

(in thousands, except share and per share amounts)

Balance at March 31, 2022

Loss for the period

Other comprehensive loss

Exercises 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

Balance at March 31, 2023

Loss for the period

Other comprehensive gain

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, 2023

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

UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022

Ordinary shares

comprehensive

shareholders’

income / (loss)

(in thousands, except share and per share amounts)

Balance at December 31, 2021

5 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at March 31, 2022

Balance at June 30, 2022

Balance at December 31, 2022

5 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at March 31, 2023

Balance at June 30, 2023

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)

3 unchanged sentences

Share-based compensation expense

Royalty financing agreement interest expense

Deferred tax income

10 unchanged sentences

Proceeds on maturity of investment securities

Acquisition of Corlieve, net of cash acquired

Acquisition of uniQure France SAS, net of cash acquired

Net cash generated from / (used in) investing activities

Cash flows from financing activities

Proceeds from royalty financing agreement

Payment of debt issuance costs

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

14 unchanged sentences

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

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

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

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

11 unchanged sentences

GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

The unaudited consolidated financial statements are presented in U.S.

dollars, except where otherwise indicated.

The unaudited consolidated financial statements are presented in United States (“U.S.”) dollars, except where otherwise indicated.

Transactions denominated in currencies other than U.S.

5 unchanged sentences

GAAP have been omitted.

The results of operations for the three months ended March 31, 2023, are not necessarily indicative of the results to be expected for the full year ending December 31, 2023, 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 filed by the Company with the SEC on February 27, 2023 (the “Annual Report”).

The results of operations for the three and six months ended June 30, 2023, are not necessarily indicative of the results to be expected for the full year ending December 31, 2023, 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, 2022 filed by the Company with the SEC on February 27, 2023 (the “Annual Report”).

2.3 Use of estimates

5 unchanged sentences

statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Annual Report .

There have been no material changes in the Company’s significant accounting policies during the three months ended March 31, 2023.

There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2023, except as noted below.

Royalty Financing Agreement

In May 2023, uniQure biopharma B.V.

(“uniQure biopharma”), a wholly-owned subsidiary of the Company entered into an agreement (the “Royalty Financing Agreement”) with HemB SPV (the “Purchaser”) to sell certain current and future royalties due to uniQure biopharma from CSL Behring LLC (“CSL Behring”) under the Commercialization and License Agreement (“the CSL Behring Agreement”) by and between uniQure biopharma and CSL Behring from the net sales of HEMGENIX®.

Refer to Note 9 “Royalty Financing Agreement” for further details of the Royalty Financing Agreement.

The Company determined that the Royalty Financing Agreement should be accounted for as debt in accordance with topic ASC 470, Debt .

The Company initially recognized the debt at fair value.

The Company subsequently records the debt at amortized cost and determines the effective interest rate based on its projection of contractual cash flows.

Interest expense (presented as “Interest Expense” in the consolidated statements of operations and comprehensive loss) is recorded over the projected repayment period using the effective interest method.

The Company periodically assesses and adjusts the effective interest rate to reflect changes in projected cash flows.

The Company prospectively applies the adjusted effective interest rate following the date of change.

In accordance with topic ASC 835, Interest , debt issuance costs incurred in relation to the Royalty Financing Agreement are presented as a reduction of carrying amount of the debt.

Debt issuance cost is amortized together with the interest expense recorded.

2.5 Recent accounting pronouncements

There have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2023, as compared to the recent accounting pronouncements described in Note 2.3.25 of the 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 six months ended June 30, 2023, as compared to the recent accounting pronouncements described in Note 2.3.25 of the 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 the Company 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 HEMGENIX® (the “Product”).

The transaction became fully effective on May 6, 2021 (“Closing”).

On June 24, 2020, uniQure biopharma B.V.

entered into the CSL Behring Agreement with CSL Behring, pursuant to which CSL Behring received exclusive global rights to HEMGENIX® .

The transaction became fully effective on May 6, 2021.

License revenue

The Company recognized $ 0.8 million of royalty revenue in each of the three and six months ended June 30, 2023, compared to nil in the three and six months ended June 30, 2022.

Royalties on the sale of the HEMGENIX® are recorded once earned and are presented as license revenue.

Accounts receivable and contract asset

As of December 31, 2022, the Company recorded accounts receivable of $ 2.2 million from CSL Behring related to collaboration services as well as a contract asset of $ 100.0 million associated to a milestone due from CSL Behring following the first sale of HEMGENIX® in the U.S.

As of December 31, 2022, the Company recorded accounts receivable of $ 2.2 million from CSL Behring related to collaboration services as well as a contract asset of $ 100.0 million for a milestone due from CSL Behring following the first sale of HEMGENIX® in the U.S.

, which was deemed to be probable.

As of March 31, 2023, the Company had accounts receivable of $ 4.8 million from CSL Behring related to collaboration services and contract manufacturing revenue and as well as the contract asset of $ 100.0 million.

As of June 30, 2023, the Company had accounts receivable of $ 102.5 million from CSL Behring.

The $ 100.0 million milestone is included in accounts receivable as of June 30, 2023 following the achievement of the milestone event in June 2023.

The Company collected the $ 100.0 million in July 2023.

The remaining accounts receivable related to collaboration services, contract manufacturing revenue, and royalty revenue.

Investment securities

The following tables summarize the Company’s investments in sovereign debt as of March 31, 2023 and December 31, 2022:

At March 31, 2023

The following tables summarize the Company’s investments in sovereign debt as of June 30, 2023 and December 31, 2022:

At June 30, 2023

Amortized cost, as adjusted

16 unchanged sentences

Inputs to the fair value of the investments are considered Level 2 inputs.

The following table summarizes the inventory balances as of June 30, 2023 and December 31, 2022:

(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 from licensing and collaboration partners, prepaid expenses, other assets, accounts payable, accrued expenses and other current liabilities reflected in the Consolidated balance sheets approximate their fair values due to their short-term maturities.

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, 2023, and December 31, 2022:

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, 2023, and December 31, 2022:

Quoted prices

12 unchanged sentences

Total liabilities

At March 31, 2023

At June 30, 2023

Cash and cash equivalents

8 unchanged sentences

Contingent consideration

The Company is required to pay up to EUR 178.8 million ($ 194.5 million at March 31, 2023) at March 31, 2023 to the former shareholders of Corlieve Therapeutics SAS (“Corlieve”) upon the achievement of contractually defined milestones in connection with the Company’s acquisition of Corlieve.

The fair value of the contingent consideration as of March 31, 2023 was $ 36.9 million (December 31, 2022:

The Company is required to pay up to EUR 178.8 million (or $ 194.6 million based on the foreign exchange rate on June 30, 2023) to the former shareholders of Corlieve Therapeutics SAS (“uniQure France SAS”) upon the achievement of contractually defined milestones in connection with the Company’s July 2021 acquisition of uniQure France SAS.

The fair value of the contingent consideration as of June 30, 2023 was $ 37.2 million (December 31, 2022:

$ 35.3 million) using discount rates of approximately 15.0 % to 15.3 % (December 31, 2022:

14.0 % to 14.4 %) as well as a 66.0 % (December 31, 2022:

66.0 %) 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 March 31, 2023 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 $ 51.0 million.

If as of March 31, 2023 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, 2022 and March 31, 2023:

66.0 %) likelihood of the target candidate for treatment of temporal lobe epilepsy (“AMT-260”) advancing into clinical development by no later than late 2023.

If as of June 30, 2023 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 $ 51.5 million.

If as of June 30, 2023 the Company had 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 and comprehensive loss.

The following table presents the changes in fair value of contingent consideration between December 31, 2022 and June 30, 2023:

consideration

3 unchanged sentences

Currency translation effects

Balance at March 31, 2023

As of March 31, 2023, the Company classified $ 27.3 million of the total contingent consideration of $ 36.9 million as current liabilities.

Balance at June 30, 2023

As of June 30, 2023, the Company classified $ 27.7 million of the total contingent consideration of $ 37.2 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.

Investment securities

Refer to Note 4 “ Investment securities ” for the fair value of the investment securities as of March 31, 2023 and December 31, 2022.

Refer to Note 4 “ Investment securities ” for the fair value of the investment securities as of June 30, 2023 and December 31, 2022.

Accrued expenses and other current liabilities

3 unchanged sentences

Personnel related accruals and liabilities

Liability owed to the Purchaser pursuant to the Royalty Financing Agreement

Accrued contract fulfillment costs and costs to obtain a contract

2 unchanged sentences

(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”).

The Company drew down an additional $ 30.0 million at the time of the 2021 Restated Facility, resulting in total principal outstanding $ 100.0 million.

The 2021 Restated Facility matures on December 1, 2025.

The facility was amended and restated in 2014, 2016, 2018, January 2021, December 2021 (the “2021 Restated Facility”) and on May 12, 2023 (the “2023 Amended Facility”).

Upon entering into the 2021 Restated Facility, the Company drew down an additional $ 30.0 million, resulting in total principal outstanding of $ 100.0 million.

The 2023 Amended Facility extends the maturity date and interest-only period from December 1, 2025 to January 5, 2027 (the “Maturity Date”).

The Company is required to repay the entire principal balance on the Maturity Date.

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

Under the 2021 Restated Facility, the Company owes a back-end fee of $ 2.5 million on June 1, 2023 and a back-end fee of $ 4.9 million on the maturity date.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2021 Restated Facility was $ 104.3 million as of March 31, 2023, compared to $ 103.8 million as of December 31, 2022, and is recorded net of discount and debt issuance costs.

The foreign currency gain on the facility in the three ended March 31, 2023 was $ 0.7 million compared to a foreign currency loss of $ 2.1 million during the same period in 2022.

Interest expense associated with the 2021 Restated Facility during the three months ended March 31, 2023 was $ 3.6 million, compared to $ 2.4 million during the same period in 2022.

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

The Company paid a $ 2.5 million back-end fee in June 2023.

Under the 2023 Amended Facility, the Company owes a back-end fee of $ 4.9 million on December 1, 2025 and a back-end fee of $ 1.3 million on the Maturity Date.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2023 Amended Facility was $ 102.2 million as of June 30, 2023, compared to $ 103.8 million as of December 31, 2022, and is recorded net of discount and debt issuance costs.

The foreign currency gain on the facility in the three and six months ended June 30, 2023 was $ 0.8 million and $ 1.6 million, respectively, compared to a foreign currency loss of $ 6.3 million and $ 8.4 million during the same period in 2022.

Interest expense associated with the 2023 Amended Facility during the three and six months ended June 30, 2023 was $ 3.7 million and $ 7.3 million, respectively, compared to $ 2.6 million and $ 5.0 million during the same period in 2022.

Under the 2023 Amended Facility the Company must remain current in its periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the U.S.

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.

Beginning on April 1, 2024, the Company is required to keep a minimum of unrestricted cash equal to at least 30 % of the loan amount outstanding.

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 $ 631.0 million, less $ 26.0 million of cash and cash equivalents and other current assets held by uniQure N.V.

and $ 85.7 million of other current assets and investment held by Corlieve.

Under the 2021 Restated Facility, the occurrence of a material adverse effect, as defined therein, would entitle Hercules to declare all principal, interest and other amounts owed by the Company immediately due and payable.

As of March 31, 2023, the Company was in material compliance with all covenants and provisions.

In combination with other covenants, the 2023 Amended Facility restricts the Company’s ability to, among other things, incur future indebtedness and obtain additional debt financing, to make investments in securities or in other companies, to transfer assets, to perform certain corporate changes, to make loans to employees, officers, and directors, and to make dividend payments and other distributions to its shareholders.

The Company secured the facilities by directly or indirectly pledging its total assets of $ 942.8 million, less $ 3.9 million of cash and cash equivalents and other current assets held by the Company, $ 86.7 million of other current assets and investment held by uniQure France SAS as well as receivables sold to the Purchaser.

Under the 2023 Amended Facility, the occurrence of a material adverse effect, as defined therein, would entitle Hercules to declare all principal, interest and other amounts owed by the Company immediately due and payable.

As of June 30, 2023, the Company was in material compliance with all covenants and provisions.

9 Royalty Financing Agreement

On May 12, 2023, the Company entered into the Royalty Financing Agreement with the Purchaser.

Under the terms of the Royalty Financing Agreement the Company received an upfront payment of $ 375.0 million in exchange for its rights to the lowest royalty tier on CSL Behring’s worldwide net sales of HEMGENIX® for certain current and future royalties due to us.

The Company is also eligible to receive an additional $ 25.0 million milestone payment under the Royalty Financing Agreement if 2024 net sales of HEMGENIX® exceed certain thresholds, as set forth in the Royalty Financing Agreement.

The Purchaser will receive 1.85 times the upfront payment (or $ 693.8 million) and 1.85 times the $ 25.0 million milestone payment (if paid) until June 30, 2032 (“First Hard Cap Date”) if such thresholds are met or, if such cap is not met by June 30, 2032, up to 2.25 times of the upfront and milestone payment (if paid) through December 31, 2038.

If 2024 net sales do not exceed the pre-specified threshold, the Company will be obligated to pay $ 25.0 million to the Purchaser but only to the extent that the Company achieves a future sales milestone under the CSL Behring Agreement.

If such milestone payment is not due from CSL Behring, the Company is not obligated to pay any amounts to the Purchaser.

The Company has retained the rights to all other royalties, as well as contractual milestones totaling up to $ 1.5 billion, under the terms of the CSL Behring Agreement.

Net proceeds from the Royalty Financing Agreement, after deducting professional and financial advisory fees related to the transaction of $ 4.9 million, were $ 370.1 million.

The Company initially recorded these net proceeds as “Liability from royalty financing agreement” on its balance sheet as of closing of the transaction on June 5, 2023.

Following the initial recognition, the Company records the debt at amortized cost.

The Company expects to satisfy its commitment to Purchaser prior to the First Hard Cap Date.

The Company will record the difference of $ 323.7 million between the total expected payments of $ 693.8 million to the Purchaser and the $ 370.1 million net proceeds as interest expense using the effective interest rate method.

The Company determined the effective interest rate based on the projected cash flows up to the First Hard Cap Date.

Based on the Company’s projections the effective interest rate is expected to be within a range of 12.0 % per annum to 13.5 % per annum.

The Company would have recorded $ 3.1 million and $ 3.5 million of interest expense, with a rate of 12.0 % and 13.5 % respectively, for the three and six months ended June 30, 2023.

The Company will prospectively update the effective interest rate at each reporting date based on updated projections.

The liability was initially recognized at fair value and inputs were considered Level 3 inputs.

The following table presents the movement in the liability related to the Royalty Financing Agreement between the closing of the transaction on June 5, 2023 and June 30, 2023:

Amount of liability

(in thousands)

Gross proceeds from royalty financing agreement on June 5, 2023

Debt issuance costs paid

Liability owed to the Purchaser (presented as "Accrued expense and other current liabilities")

Interest expense for the period June 5, 2023 to June 30, 2023

Liability related to the royalty financing agreement

10 Share-based compensation

1 unchanged sentence

The number of shares authorized for issuance under the 2014 Plan is 12,601,471 .

On April 28, 2023, the Company filed a definitive proxy statement with the SEC, seeking shareholder approval to, among other things, amend and restate the 2014 Plan to increase the shares available thereunder.

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 2014 Plan expires on January 9, 2024.

In June 2018, the Company’s shareholders adopted and approved an employee share purchase plan (the “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.

3 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 March 31,

Three months ended June 30,

Six months ended June 30,

(in thousands)

Cost of manufacturing services revenue

1 unchanged sentence

Selling, general and administrative

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

Three months ended March 31,

Share-based compensation expense recognized by award type for 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

3 unchanged sentences

Employee share purchase plan

As of March 31, 2023, the unrecognized share-based compensation expense related to unvested awards under the 2014 Plans were:

As of June 30, 2023, the unrecognized share-based compensation expense related to unvested awards under the 2014 Plans were:

Weighted average

6 unchanged sentences

Share options are priced on the date of grant and, except for certain grants made to non-executive directors, vest over a period of four years .

The first 25 % vests after one year from the initial grant date and the remainder vests in equal quarterly installments over years two, three and four.

The first 25 % of each grant vests after one year from the initial grant date and the remainder vests in equal quarterly installments over years two, three and four.

Certain grants to non-executive directors vest in full after one year .

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

The following tables summarize share option activity under the 2014 Plans for the three months ended March 31, 2023:

All share options must be exercised by the tenth anniversary of the initial grant date.

The following tables summarize share option activity under the 2014 Plans for the six months ended June 30, 2023:

Weighted average

2 unchanged sentences

Outstanding at December 31, 2022

Outstanding at March 31, 2023

Thereof, fully vested and exercisable on March 31, 2023

Thereof, outstanding and expected to vest after March 31, 2023

Outstanding at June 30, 2023

Thereof, fully vested, and exercisable on June 30, 2023

Thereof, outstanding and expected to vest after June 30, 2023

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

1 unchanged sentence

The fair value of each share 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

1 unchanged sentence

Risk free interest rate

3.71 % - 4.00 %

3.03 % - 3.44 %

3.71 % - 4.10 %

2.12 % - 3.44 %

Expected dividend yield

The following table summarizes the RSU activity for the three months ended March 31, 2023:

The following table summarizes the RSU activity for the six months ended June 30, 2023:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2022

Non-vested at March 31, 2023

Non-vested at June 30, 2023

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

RSUs vest over one to three years .

RSUs vest over one to three years , as specified when granted.

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

The following table summarizes the PSU activity for the three months ended March 31, 2023:

The following table summarizes the PSU activity for the six months ended June 30, 2023:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2022

Non-vested at March 31, 2023

Non-vested at June 30, 2023

The Company granted ordinary shares to certain employees in September and December 2021 and at various dates during the year ended December 31, 2022 that will be earned upon the achievement of defined milestones.

2 unchanged sentences

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

Achievement of one of the total five defined milestones was met as of December 31, 2022 and another one of the total five defined milestones was met as of March 31, 2023.

During the three months ended March 31, 2023, 2,495 ordinary shares were issued under the ESPP compared to 3,558 during the same period in 2022.

As of March 31, 2023, a total of 113,565 ordinary shares remains available for issuance under the ESPP plan compared to a total of 123,744 as of March 31, 2022.

The Company recorded $ 1.2 million deferred tax benefit in relation to its operations in the United States and France during the three months ended March 31, 2023.

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

The effective income tax rate of ( 1.5 %) during the three months ended March 31, 2023 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 months ended March 31, 2022 was ( 1.3 %) as the Company had recorded a valuation allowance against its net deferred tax assets in the Netherlands.

Achievement of one of the total five defined milestones was met as of December 31, 2022 and another one of the total five defined milestones was met as of June 30, 2023.

The remaining three milestones have not yet been met.

During the six months ended June 30, 2023, 5,006 ordinary shares were issued under the ESPP compared to 5,890 during the same period in 2022.

As of June 30, 2023, 111,054 ordinary shares remain available for issuance under the ESPP compared to a total of 121,414 as of June 30, 2022.

The Company recorded $ 0.2 million deferred tax loss and $ 1.0 million deferred tax benefit in relation to its operations in the U.S.

and France during the three and six months ended June 30, 2023, respectively.

The Company recorded $ 0.3 million and $ 0.9 million deferred tax benefit in relation to its operations in the U.S.

and France during the three and six months ended June 30, 2022, respectively.

The effective income tax rate of 0.2 % and ( 0.7 %) during the three and six months ended June 30, 2023 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 six months ended June 30, 2022 was ( 0.8 %) and ( 1.1 %), respectively, as the Company had recorded a valuation allowance against its net deferred tax assets in the Netherlands.

12 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 ordinary 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, 2023 and March 31, 2022, respectively.

As the Company has incurred a loss in the three and six months ended June 30, 2023, all potentially dilutive ordinary shares 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, 2023.

The ordinary 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 June 30, 2023 and June 30, 2022, respectively.

The potentially dilutive ordinary shares are summarized below:

Three months ended March 31,

Three months ended June 30,

Six months ended June 30,

Anti-dilutive ordinary share equivalents

4 unchanged sentences

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What changed 10-Q

Item 1. Financial Statements