What changed in this filing

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Item 1. Financial Statements

2023-11-07 compared with 2023-08-01 · 104 added, 89 removed, 369 unchanged (34% of the section changed)

1 unchanged sentence

UNAUDITED CONSOLIDATED BALANCE SHEETS

September 30,

(in thousands, except share and per share amounts)

7 unchanged sentences

Non-current assets

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

Property, plant and equipment, net of accumulated depreciation of $ 51.6 million as of September 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 in-process research and development asset of $ 58.3 million as of June 30, 2023 and $ 57.3 million as of December 31, 2022

Intangible assets, net, including in-process research and development asset of $ 56.6 million as of September 30, 2023 and $ 57.3 million as of December 31, 2022

Deferred tax assets, net

19 unchanged sentences

Ordinary shares, € 0.05 par value:

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

80,000,000 shares authorized as of September 30, 2023 and December 31, 2022 and 47,810,291 and 46,968,032 ordinary shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

Additional paid-in-capital

6 unchanged sentences

COMPREHENSIVE LOSS

Three months ended June 30,

Six months ended June 30,

Three months ended September 30,

Nine months ended September 30,

(in thousands, except share and per share amounts)

16 unchanged sentences

Loss before income tax benefit

Income tax (expense )/ benefit

Income tax benefit

Other comprehensive loss:

5 unchanged sentences

UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

FOR THE THREE MONTHS ENDED JUNE 30, 2023 AND 2022

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022

Ordinary shares

1 unchanged sentence

shareholders’

income / (loss)

(in thousands, except share and per share amounts)

Balance at March 31, 2022

Balance at June 30, 2022

Loss for the period

4 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at September 30, 2022

Balance at June 30, 2023

Balance at March 31, 2023

Loss for the period

Other comprehensive gain

Other comprehensive loss

Exercises of share options

2 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at June 30, 2023

Balance at September 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

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022

Ordinary shares

1 unchanged sentence

shareholders’

income / (loss)

(in thousands, except share and per share amounts)

6 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at June 30, 2022

Balance at September 30, 2022

Balance at December 31, 2022

Loss for the period

Other comprehensive gain

Other comprehensive loss

Exercises of share options

2 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at June 30, 2023

Balance at September 30, 2023

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)

2 unchanged sentences

Depreciation and amortization expense

Amortization of premium/discount on investment securities

Share-based compensation expense

8 unchanged sentences

Accrued expenses, other liabilities, and operating leases

Contingent consideration milestone payment

Net cash used in operating activities

Cash flows from investing activities

Purchases of property, plant, and equipment

Investment in investment securities

Proceeds on maturity of investment securities

Acquisition of uniQure France SAS, net of cash acquired

Net cash generated from / (used in) investing activities

Purchases of property, plant, and equipment

Acquisition of uniQure France SAS (formerly Corlieve Therapeutics SAS), net of cash acquired

Net cash used in investing activities

Cash flows from financing activities

2 unchanged sentences

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

Contingent consideration milestone payment

Net cash generated from financing activities

Currency effect on cash, cash equivalents and restricted cash

Net decrease in cash, cash equivalents and restricted cash

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

Cash, cash equivalents and restricted cash at beginning of period

5 unchanged sentences

Cash paid for interest

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

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

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

24 unchanged sentences

GAAP have been omitted.

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 results of operations for the three and nine months ended September 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”).

6 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 six months ended June 30, 2023, except as noted below.

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

Royalty Financing Agreement

11 unchanged sentences

2.5 Recent accounting pronouncements

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.

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

3 unchanged sentences

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.

The Company recognized $ 0.5 million and $ 1.3 million of royalty revenue in each of the three and nine months ended September 30, 2023, compared to nil in the three and nine months ended September 30, 2022.

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

1 unchanged sentence

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 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.

, which was collected in July 2023.

As of September 30, 2023, the Company had accounts receivable of $ 1.6 million from CSL Behring 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 June 30, 2023 and December 31, 2022:

At June 30, 2023

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

At September 30, 2023

Amortized cost, as adjusted

15 unchanged sentences

Government debt securities (held-to-maturity)

The Company invests in short-term U.S.

and European government bonds with the highest investment credit rating.

and European government bonds are U.S.

dollar and euro denominated, respectively.

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:

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

September 30,

(in thousands)

12 unchanged sentences

A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

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 June 30, 2023, and December 31, 2022:

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

The following table sets forth the Company’s assets and liabilities that are required to be measured at fair value on a recurring basis as of September 30, 2023, and December 31, 2022:

Quoted prices

12 unchanged sentences

Total liabilities

At June 30, 2023

At September 30, 2023

Cash and cash equivalents

8 unchanged sentences

Contingent consideration

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:

The Company is required to pay up to EUR 178.8 million (or $ 189.1 million based on the foreign exchange rate on September 30, 2023) to the former shareholders of uniQure France SAS (formerly Corlieve Therapeutics SAS) upon the achievement of contractually defined milestones in connection with the Company’s July 2021 acquisition of uniQure France SAS.

In September 2023, a milestone payment of EUR 10.0 million ($ 10.6 million) was paid, of which EUR 8.9 million ($ 9.6 million) related to contingent consideration.

The fair value of the contingent consideration as of September 30, 2023 was $ 40.7 million (December 31, 2022:

$ 35.3 million) using discount rates of approximately 15.0 % to 15.5 % (December 31, 2022:

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

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.

14.0 % to 14.4 %).

Following the clearance of an Investigational New Drug (“IND”) application for AMT-260 in August 2023, the Company increased the probability of achieving a EUR 30.0 million ($ 31.7 million) milestone payment due to the first patient dosed in Phase I/II clinical trial from 66.0 % to 100.0 %.

This also resulted in an increase of, the probability that AMT-260 may advance to late-stage development and commercialization.

The Company recorded $ 14.2 million and $ 15.4 million in expenses related to the changes in the fair value of the contingent consideration in the three and nine months ended September 30, 2023, respectively, compared to $ 5.5 million and $ 7.5 million during the same period in 2022.

If as of September 30, 2023 the Company had assumed a 100 % likelihood of AMT-260 advancing into a Phase III clinical study, then the fair value of the contingent consideration would have increased to $ 72.0 million.

If as of September 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:

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

consideration

2 unchanged sentences

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

Contingent consideration milestone payment

Currency translation effects

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.

Balance at September 30, 2023

As of September 30, 2023, the Company classified $ 26.7 million of the total contingent consideration of $ 40.7 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.

Investment securities

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

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

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities include the following items:

September 30,

(in thousands)

7 unchanged sentences

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 total principal outstanding under the 2023 Amended Facility is $ 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.

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

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.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2023 Amended Facility was $ 102.5 million as of September 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 loss on the facility in the three and nine months ended September 30, 2023 was $ 3.0 million and $ 1.4 million, respectively, compared to a foreign currency loss of $ 6.6 million and $ 15.0 million during the same period in 2022.

Interest expense associated with the 2023 Amended Facility during the three and nine months ended September 30, 2023 was $ 3.7 million and $ 10.9 million, respectively, compared to $ 3.0 million and $ 8.1 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.

5 unchanged sentences

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.

As of September 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.

6 unchanged sentences

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 expects to satisfy its commitment to the 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.

1 unchanged sentence

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 would have recorded between $ 14.6 million and $ 16.5 million of interest expense through the nine months ended September 30, 2023 ($ 11.5 million and $ 13.0 million, respectively, for the three months ended September 30, 2023) if it had used 12.0 % or 13.5 %, instead of the $ 14.9 million recorded in the nine months ended September 30, 2023 ($ 11.8 million recorded through the three months ended September 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:

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 September 30, 2023:

Amount of liability

2 unchanged sentences

Debt issuance costs paid

Royalty payments to Purchaser

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

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

Liability related to the royalty financing agreement

4 unchanged sentences

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.

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

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

2 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 for 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)

5 unchanged sentences

Employee share purchase plan

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

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

Weighted average

9 unchanged sentences

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:

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

Weighted average

2 unchanged sentences

Outstanding at December 31, 2022

Outstanding at June 30, 2023

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

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

Outstanding at September 30, 2023

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

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

Six months ended June 30,

Three months ended September 30,

Nine months ended September 30,

Expected volatility

4 unchanged sentences

2.12 % - 4.16 %

2.12 % - 3.44 %

Expected dividend yield

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

The following table summarizes the RSU activity for the nine months ended September 30, 2023:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2022

Non-vested at June 30, 2023

Non-vested at September 30, 2023

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

1 unchanged sentence

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

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

The following table summarizes the PSU activity for the nine months ended September 30, 2023:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2022

Non-vested at June 30, 2023

Non-vested at September 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 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.

As of September 30, 2023, two milestones had been achieved.

Additionally, another milestone is considered probable as of September 30, 2023.

During the nine months ended September 30, 2023, 12,270 ordinary shares were issued under the ESPP compared to 9,305 during the same period in 2022.

As of September 30, 2023, 103,790 ordinary shares remain available for issuance under the ESPP compared to a total of 117,997 as of September 30, 2022.

The Company recorded $ 0.1 million and $ 1.1 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.

and France during the three and nine months ended September 30, 2023, respectively.

The Company recorded $ 0.3 million and $ 1.3 million deferred tax benefit in relation to its operations in the U.S.

and France during the three and nine months ended September 30, 2022, respectively.

The effective income tax rate of ( 0.1 %) and ( 0.5 %) during the three and nine months ended September 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 nine months ended September 30, 2022 was ( 0.7 %) and ( 0.9 %), 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 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.

As the Company has incurred a loss in the three and nine months ended September 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 nine months ended September 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 September 30, 2023 and September 30, 2022, respectively.

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,

Anti-dilutive ordinary share equivalents

3 unchanged sentences

13 Subsequent events

On October 5, 2023, the Company announced a reorganization plan (the “Reorganization”) pursuant to which the Company’s global workforce will be reduced by approximately 20 %.

As part of the Reorganization, more than half of the Company’s research and technology projects will be discontinued and a research lab in Lexington, Massachusetts will be closed.

The Company estimated that it will incur charges of approximately $ 2.3 million in connection with the reorganization related to cash expenditures for employee severance costs.

The Company also anticipates that there could be costs associated with the lab to be closed in Lexington and associated fixed assets if the carrying value is determined to not be recoverable as of the cease-use date, which is expected to be later in the fourth quarter of 2023.

The Company anticipates the costs associated with the reorganization will be incurred in the fourth quarter of 2023.

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