What changed in this filing

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Item 1. Financial Statements

2020-10-27 compared with 2020-07-30 · 87 added, 84 removed, 401 unchanged (30% of the section changed)

1 unchanged sentence

UNAUDITED CONSOLIDATED BALANCE SHEETS

September 30,

(in thousands, except share and per share amounts)

3 unchanged sentences

Prepaid expenses

Other current assets

Other current assets and receivables

Total current assets

Non-current assets

Property, plant and equipment, net of accumulated depreciation of $ 31.3 million as of June 30, 2020 and $ 28.6 million as of December 31, 2019, respectively

Property, plant and equipment, net of accumulated depreciation of $ 33.2 million as of September 30, 2020 and $ 28.6 million as of December 31, 2019, respectively

Operating lease right-of-use assets

19 unchanged sentences

Ordinary shares, € 0.05 par value:

60,000,000 shares authorized at June 30, 2020 and December 31, 2019 and 44,444,405 and 43,711,954 ordinary shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively

60,000,000 shares authorized at September 30, 2020 and December 31, 2019 and 44,487,510 and 43,711,954 ordinary shares issued and outstanding at September 30, 2020 and December 31, 2019, 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)

20 unchanged sentences

UNAUDITED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

FOR THE THREE-MONTH PERIOD ENDED JUNE 30

FOR THE THREE-MONTH PERIOD ENDED SEPTEMBER 30

Ordinary shares

3 unchanged sentences

(in thousands, except share and per share amounts)

Balance at March 31, 2019

Balance at June 30, 2019

Loss for the period

Other comprehensive income

Hercules warrants exercise

Other comprehensive loss

Follow-on public offering

Exercise of share options

2 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at September 30, 2019

Balance at June 30, 2020

Balance at March 31, 2020

Loss for the period

4 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at June 30, 2020

Balance at September 30, 2020

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

FOR THE NINE-MONTH PERIOD ENDED SEPTEMBER 30

Ordinary shares

6 unchanged sentences

Other comprehensive loss

Follow-on public offering

Hercules warrants exercise

3 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at June 30, 2019

Balance at September 30, 2019

Balance at December 31, 2019

Loss for the period

Other comprehensive loss

Other comprehensive income

Exercise of share options

2 unchanged sentences

Issuance of ordinary shares relating to employee stock purchase plan

Balance at June 30, 2020

Balance at September 30, 2020

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)

4 unchanged sentences

Change in fair value of derivative financial instruments

Unrealized foreign exchange gains

Unrealized foreign exchange losses / (gains)

Changes in operating assets and liabilities:

Accounts receivable and accrued income, prepaid expenses and other current assets

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

Accounts payable

8 unchanged sentences

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

Proceeds from public offering of shares, net of issuance costs

Proceeds from exercise of warrants

1 unchanged sentence

Currency effect on cash, cash equivalents and restricted cash

Net decrease in cash, cash equivalents and restricted cash

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

Cash, cash equivalents and restricted cash at beginning of period

33 unchanged sentences

GAAP have been omitted.

The results of operations for the six months ended June 30, 2020, are not necessarily indicative of the results to be expected for the full year ending December 31, 2020 or for any other future year or interim period.

The results of operations for the nine months ended September 30, 2020, are not necessarily indicative of the results to be expected for the full year ending December 31, 2020 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, 2019, filed with the SEC on March 2, 2020 .

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, 2019, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 2, 2020 .

There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2020.

There have been no material changes in the Company’s significant accounting policies during the nine months ended September 30, 2020.

2.5 Recent accounting pronouncements

There have been no new accounting pronouncements or changes to accounting pronouncements during the six months ended June 30, 2020, as compared to the recent accounting pronouncements described in Note 2.3.23 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 , 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, 2020, as compared to the recent accounting pronouncements described in Note 2.3.23 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 , which could be expected to materially impact the Company’s unaudited consolidated financial statements.

The Company has adopted ASU 2018-13, Fair Value Measurement (Topic 820) and additional disclosures related to significant unobservable inputs have been included within footnote 4 Fair value measurement.

1 unchanged sentence

CSL Behring collaboration

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

Under the terms of the CSL Behring Agreement, the Company will receive a $ 450 million upfront cash payment upon the closing of the CSL Behring Agreement and be eligible to receive up to $ 1.6 billion in payments based on regulatory and commercial milestones.

The Company will also be eligible to receive tiered double-digit royalties in a range of up to a low-twenties percent of net sales of the Product based on sales thresholds.

Pursuant to the CSL Behring Agreement, the Company will be responsible for the completion of the HOPE-B clinical trial, manufacturing process validation, and the manufacturing supply of Product until such time that these capabilities may be transferred to CSL Behring or its designated contract manufacturing organization.

Pursuant to a development and commercial supply agreement, the Company will supply Product to CSL Behring at an agreed-upon price per the contract.

The Company and CSL Behring executed the development and commercial supply agreement simultaneously with the CSL Behring Agreement.

Certain provisions will not become effective until after the Company receives regulatory approval to close the transaction.

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

Under the terms of the CSL Behring Agreement, the Company will receive a $ 450 million upfront cash payment upon the closing of the CSL Behring Agreement and be eligible to receive up to $ 1.6 billion in additional payments based on regulatory and commercial milestones.

The CSL Behring Agreement also provides that the Company will be eligible to receive tiered double-digit royalties in a range of up to a low-twenties percent of net sales of the Product based on sales thresholds.

Pursuant to the CSL Behring Agreement, the Company will be responsible for the completion of the HOPE-B clinical trial, manufacturing process validation, and the manufacturing supply of the Product until such time that these capabilities may be transferred to CSL Behring or its designated contract manufacturing organization.

Concurrently with the execution of the CSL Behring Agreement, the Company and CSL Behring entered into a development and commercial supply agreement, pursuant to which, among other things, the Company will supply the Product to CSL Behring at an agreed-upon price.

Clinical development and regulatory activities performed by the Company pursuant to the CSL Behring Agreement will be reimbursed by CSL Behring.

CSL Behring will be responsible for global regulatory submissions and commercialization requirements for Product.

CSL Behring will be responsible for global regulatory submissions and commercialization requirements for the Product.

Closing of the CSL Behring Agreement is contingent on the successful completion of reviews under antitrust laws in the United States, Australia, and the United Kingdom, which has not occurred to date.

3 unchanged sentences

In accordance with its existing license and other agreements, the Company is contractually required to pay in total a low to high single digit percentage of any upfront payment to its licensors and financial advisor (“License Fees”).

As of June 30, 2020, the Company concluded it has no enforceable right to receive any of the upfront payment, the regulatory and sales milestone payments or the royalties (together “CSL License Revenue”) that it may receive in accordance with the CSL Behring Agreement, as all payments are contingent upon the successful completion of reviews under antitrust laws in the United States, Australia and the United Kingdom.

As of September 30, 2020, the Company concluded it has no enforceable right to receive any of the upfront payment, the regulatory and sales milestone payments or the royalties (together “CSL License Revenue”) that it may receive in accordance with the CSL Behring Agreement, as all payments are contingent upon the successful completion of reviews under antitrust laws in the United States, Australia and the United Kingdom.

Therefore, the Company determined it will not recognize any revenue in relation to the CSL License Revenue, in accordance with ASC 606.

The Company determined that in accordance with Dutch taw law it will recognize the CSL Behring License Revenue as well as the License Fees as taxable results as of the date on which the Company is contractually entitled to receive (or obligated to make) a payment under the CSL Behring Agreement.

The Company expects to continue to incur taxable losses in the Netherlands except for the period in which it receives the $ 450 million upfront payment.

In the event that the Company recognizes the $ 450 million upfront payment in 2020, such payment will be subject to Dutch corporate income tax at a rate of 25.0 %.

Any CSL License Revenue including the upfront payment that the Company recognizes thereafter will be subject to Dutch corporate income tax at a rate of 21.7 %.

The Company determined that in accordance with Dutch tax law it will recognize the CSL Behring License Revenue as well as the License Fees as taxable results as of the date on which the Company is contractually entitled to receive (or obligated to make) a payment under the CSL Behring Agreement.

The Company expects to continue to incur taxable losses in the Netherlands except for the period in which it receives the $ 450 million upfront payment under the CSL Behring Agreement.

In the event that the Company recognizes the $ 450 million upfront payment in 2020, such payment is expected to be subject to Dutch corporate income tax at a rate of 25.0 %.

However, the Company does not expect it will be required to pay any income taxes in the period in which it recognizes the $ 450 million upfront payment as taxable revenue, as such payment is not expected to exceed the net operating losses the Company has carried forward in the Netherlands.

1 unchanged sentence

Future taxable income or losses of the Company and a potential reversal of the valuation allowance will be impacted by a variety of factors, of which some are outside of the Company’s control.

Such factors include the outcome and timing of the reviews under antitrust laws in the United States, Australia, and the United Kingdom, the change in the Dutch corporate income tax rate in 2021, additional net operating losses the Company may generate in relation to the CSL Behring Agreement, and the amount of License Fees the Company is required to pay.

Such factors include the outcome and timing of the reviews under antitrust laws in the United States, Australia, and the United Kingdom, additional net operating losses the Company may generate in relation to the CSL Behring Agreement, and the amount of License Fees the Company is required to pay.

The Company recognizes deferred tax assets to the extent that it determines that these assets are more likely than not to be realized.

In making such a determination, the Company weighed all available positive and negative evidence, including future income projections from the CSL Behring Agreement, and concluded that it is more likely than not that the deferred tax assets will not be realized.

Accordingly, the Company continued to record a full valuation allowance as of June 30, 2020.

Accordingly, the Company continued to record a full valuation allowance as of September 30, 2020.

Bristol-Myers Squibb collaboration

5 unchanged sentences

The BMS CLA provides that the Company and BMS may collaborate on up to ten Collaboration Targets in total.

As of June 30, 2020, BMS has designated a total of four Collaboration Targets.

As of September 30, 2020, BMS has designated a total of four Collaboration Targets.

In February 2019, BMS requested a one-year extension of the research term.

12 unchanged sentences

Amounts owed by BMS in relation the collaboration services are as follows:

September 30,

(in thousands)

1 unchanged sentence

License Revenue

The Company recognized $ 1.5 million and $ 1.6 million of License Revenue for the three and six months ended June 30, 2020, respectively, compared to $ 2.1 million and $ 2.7 million during the same periods in 2019 in relation to a $ 60.1 million upfront payment recorded on May 21, 2015, as well as $ 15.0 million received in relation to the designation of the second, third and fourth Collaboration Targets in August 2015 (together “Consideration”).

The Company recognized $ 1.8 million and $ 3.4 million of License Revenue for the three and nine months ended September 30, 2020, respectively, compared to $ 0.8 million and $ 3.5 million during the same periods in 2019 in relation to a $ 60.1 million upfront payment recorded on May 21, 2015, as well as $ 15.0 million received in relation to the designation of the second, third and fourth Collaboration Targets in August 2015 (together “Consideration”).

The Company would be entitled to an aggregate $ 16.5 million in target designation payments upon the selection of the fifth through tenth Collaboration Targets.

The Company would also be eligible to receive research, development and regulatory milestone payments of up to $ 254.0 million for a lead Collaboration Target and up to $ 217.0 million for each of the other selected Collaboration Targets, if defined milestones are achieved.

The Company would also be eligible to receive research, development and regulatory milestone payments of up to $ 217.0 million for each Collaboration Target, if defined milestones are achieved.

The Company would include the variable consideration related to the selection of the fifth to tenth Collaboration Target, or any of the milestones, in the transaction price once it is considered probable that including these payments in the transaction price would not result in the reversal of cumulative revenue recognized.

20 unchanged sentences

The carrying amount of cash and cash equivalents, accrued income from the related party, 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, 2020, and December 31, 2019:

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, 2020, and December 31, 2019:

Quoted prices

8 unchanged sentences

Total liabilities

At June 30, 2020

At September 30, 2020

Cash, cash equivalents and restricted cash

3 unchanged sentences

Total liabilities

Changes in Level 3 items during the six months ended June 30, 2020, are as follows:

Changes in Level 3 items during the nine months ended September 30, 2020, are as follows:

(in thousands)

2 unchanged sentences

Currency translation effects

Balance at June 30, 2020

Balance at September 30, 2020

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

The fair value of the BMS derivative financial instruments (“BMS warrants”) as of June 30, 2020, was $ 0.8 million compared to a fair value of $ 3.1 million as of December 31, 2019.

The fair value of the BMS derivative financial instruments (“BMS warrants”) as of September 30, 2020, was $ 0.5 million compared to a fair value of $ 3.1 million as of December 31, 2019.

Changes in the fair value of the BMS warrants are primarily impacted by changes in the Company’s share price, whereby a decrease in share price generally results in a decrease of the fair value.

8 unchanged sentences

and (ii) the date on which BMS designates the ninth new target (the tenth Collaboration Target).

Pursuant to the terms of the BMS CLA, the exercise price in respect of each warrant is equal to the greater of (i) the product of (A) $ 33.84 and (B) a compounded annual growth rate of 10 % (or approximately $ 55.07 as of June 30, 2020) and (ii) the product of (A) 1.10 and (B) the VWAP for the 20 trading days ending on the date that is five trading days prior to the date of a notice of exercise delivered by BMS.

As of June 30, 2020, BMS had designated a total of four Collaboration Targets, and as such, the warrants were not exercisable.

The Company estimated the exercise of warrants to occur within four and five years after the balance sheet date.

Pursuant to the terms of the BMS CLA, the exercise price in respect of each warrant is equal to the greater of (i) the product of (A) $ 33.84 and (B) a compounded annual growth rate of 10 % (or approximately $ 56.41 as of September 30, 2020) and (ii) the product of (A) 1.10 and (B) the VWAP for the 20 trading days ending on the date that is five trading days prior to the date of a notice of exercise delivered by BMS.

As of September 30, 2020, BMS had designated a total of four Collaboration Targets, and as such, the warrants were not exercisable.

The Company estimated the exercise of warrants to occur within three and five years after the balance sheet date.

The significant unobservable inputs that the Company uses to develop Level 3 fair value measurements include the number of ordinary shares outstanding at the time of BMS’s warrant exercises.

18 unchanged sentences

In February 2020, the Company amended the agreement to sub-lease to take back one of the three floors effective March 1, 2020.

The fixed lease payments to be received during the remaining term under the agreement to sub-lease amount to $ 6.4 million (EUR 5.7 million) as of June 30, 2020.

The fixed lease payments to be received during the remaining term under the agreement to sub-lease amount to $ 6.4 million (EUR 5.5 million) as of September 30, 2020.

The table below presents the components of the Company’s lease costs for the periods indicated:

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

The table below presents the lease-related assets and liabilities recorded on the Consolidated balance sheets for the periods indicated.

September 30,

(in thousands)

4 unchanged sentences

Other information

The weighted-average remaining lease term as of June 30, 2020 is 9.8 years, compared to 10.3 years as of December 31, 2019 and the weighted-average discount rate as of June 30, 2020 is 11.33 %, compared to 11.33 % as of December 31, 2019.

The weighted-average remaining lease term as of September 30, 2020 is 9.6 years, compared to 10.3 years as of December 31, 2019 and the weighted-average discount rate as of September 30, 2020 is 11.35 %, compared to 11.33 % as of December 31, 2019.

The Company derived the weighted-average discount rate, adjusted for differences such as in the term and payment patterns, from the Company’s loan from Hercules Capital which was refinanced immediately prior to the January 1, 2019 adoption date in December 2018.

Cash paid for amounts included in the measurement of lease liabilities 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)

1 unchanged sentence

Operating cash flows for operating leases 1)

The Company did not obtain any right-of-use assets in exchange for lease obligations in the three and six months ended June 30, 2020.

Besides the initial recognition of operating right-of-use assets of $ 19.0 million upon adoption of the new lease standards on January 1, 2019, the Company obtained $ 8.6 million of additional right-of-use assets in exchange for lease obligations in the three and six months ended June 30, 2019.

( 1) The Company has received $ 0.5 million of landlord incentive payments in the three months ended September 30, 2019, which are not included in the cash paid amounts for the three and nine months ended September 30, 2019.)

The Company did not obtain any right-of-use assets in exchange for lease obligations in the three and nine months ended September 30, 2020.

Besides the initial recognition of operating right-of-use assets of $ 19.0 million upon adoption of the new lease standards on January 1, 2019, the Company obtained $ 0.4 million and $ 9.0 million of additional right-of-use assets in exchange for lease obligations in the three and nine months ended September 30, 2019, respectively.

Undiscounted cash flows

The table below reconciles the undiscounted cash flows as of June 30, 2020, for each of the first five years and the total of the remaining years to the operating lease liabilities recorded on the Consolidated balance sheet as of June 30, 2020.

The table below reconciles the undiscounted cash flows as of September 30, 2020, for each of the first five years and the total of the remaining years to the operating lease liabilities recorded on the Consolidated balance sheet as of September 30, 2020.

(in thousands)

2020 (six months remaining)

2020 (three months remaining)

Total lease payments

3 unchanged sentences

Non-current operating lease liabilities

( 1) Payments are due in EUR and have been translated at the foreign exchange rate as of June 30, 2020, of $ 1.12 / €1.00).

( 1) Payments are due in EUR and have been translated at the foreign exchange rate as of September 30, 2020, of $ 1.17 / €1.00).

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities include the following items:

September 30,

(in thousands)

12 unchanged sentences

In addition, in May 2020 the Company paid a back-end fee of $ 1.0 million in relation to the 2016 Amended Facility.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2018 Amended Facility was $ 35.6 million as of June 30, 2020, compared to $ 36.3 million as of December 31, 2019, and is recorded net of discount and debt issuance costs.

The foreign currency gain on the loan in the three and six months ended June 30, 2020, was $ 0.7 million and $ 0.0 million compared to a foreign currency gain of $ 0.5 million during the three months ended June 30, 2019, and a foreign currency loss of $ 0.2 million during the six months ended June 30, 2019.

Interest expense associated with the 2018 Amended Facility during the three and six months ended June 30, 2020 was $ 0.9 million and $ 1.8 million, respectively, compared to $ 0.9 million and $ 1.9 million during the same periods in 2019.

The amortized cost (including interest due presented as part of accrued expenses and other current liabilities) of the 2018 Amended Facility was $ 35.8 million as of September 30, 2020, compared to $ 36.3 million as of December 31, 2019, and is recorded net of discount and debt issuance costs.

The foreign currency gain on the loan in the three and nine months ended September 30, 2020, was $ 1.5 million and $ 1.5 million compared to a foreign currency loss of $ 1.5 million and $ 1.7 million during the same periods in 2019.

Interest expense associated with the 2018 Amended Facility during the three and nine months ended September 30, 2020 was $ 0.9 million and $ 2.7 million, respectively, compared to $ 0.9 million and $ 2.8 million during the same periods in 2019.

As a covenant in the 2018 Amended Facility, the Company has periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the United States, equivalent to the lesser of (i) 65 % of the outstanding balance of principal due or (ii) 100% of worldwide cash and cash equivalents.

3 unchanged sentences

The 2018 Amended 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, 2020, the Company was in compliance with all covenants and provisions.

As of September 30, 2020, the Company was in compliance with all covenants and provisions.

8 Share-based compensation

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 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)

3 unchanged sentences

Share-based compensation expense recognized by award type 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)

3 unchanged sentences

Performance share units (“PSUs”)

As of June 30, 2020, the unrecognized share-based compensation expense related to unvested awards under the 2014 Plans were:

As of September 30, 2020, the unrecognized share-based compensation expense related to unvested awards under the 2014 Plans were:

Weighted average

5 unchanged sentences

Share options

The following table summarizes option activity for the six months ended June 30, 2020:

The following table summarizes option activity for the nine months ended September 30, 2020:

Weighted average

2 unchanged sentences

Outstanding at December 31, 2019

Outstanding at June 30, 2020

Thereof, fully vested and exercisable at June 30, 2020

Thereof, outstanding and expected to vest after June 30, 2020

Outstanding at September 30, 2020

Thereof, fully vested and exercisable at September 30, 2020

Thereof, outstanding and expected to vest after September 30, 2020

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

3 unchanged sentences

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

1.92 % - 2.87 %

0.76 % - 1.44 %

2.17 % - 2.87 %

Expected dividend yield

Restricted share units (“RSUs”)

The following table summarizes the RSUs activity for the six months ended June 30, 2020:

The following table summarizes the RSUs activity for the nine months ended September 30, 2020:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2019

Non-vested at June 30, 2020

Non-vested at September 30, 2020

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, 2020:

The following table summarizes the PSUs activity for the nine months ended September 30, 2020:

Weighted average

2 unchanged sentences

Non-vested at December 31, 2019

Non-vested at June 30, 2020

Non-vested at September 30, 2020

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

7 unchanged sentences

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

During the six months ended June 30, 2020, 3,005 ordinary shares were issued under the ESPP compared to 4,870 during the same period in 2019.

As of June 30, 2020, a total of 135,202 ordinary shares remains available for issuance under the ESPP plan compared to a total of 142,539 as of June 30, 2019.

During the nine months ended September 30, 2020, 3,282 ordinary shares were issued under the ESPP compared to 7,018 during the same period in 2019.

As of September 30, 2020, a total of 134,925 ordinary shares remains available for issuance under the ESPP plan compared to a total of 140,391 as of September 30, 2019.

Deferred tax assets and deferred tax liabilities are recognized based on the expected future tax consequences of temporary differences between the financial statement carrying amounts and the income tax basis of assets and liabilities, using current statutory rates.

4 unchanged sentences

In its assessment of whether or not it was more likely than not that the Company’s deferred tax assets will be realized, the Company considered all relevant facts and circumstances, including in particular similar regulatory reviews as well as the three-year cumulative losses reported by the Company.

The Company concluded that it should continue to record a full valuation allowance as of June 30, 2020.

The Company concluded that it should continue to record a full valuation allowance as of September 30, 2020.

As of December 31, 2019, the Company’s valuation allowance amounted to $ 109.9 million.

2 unchanged sentences

As the Company has incurred a loss, all potentially dilutive ordinary shares would have an antidilutive effect, if converted, and thus have been excluded from the computation of loss per share.

The shares are presented without giving effect to the application of the treasury method or exercise prices that would be above the share price as of June 30, 2020 and June 30, 2019, respectively.

The shares are presented without giving effect to the application of the treasury method or exercise prices that would be above the share price as of September 30, 2020 and September 30, 2019, respectively.

In addition, the BMS warrants were not exercisable as of these dates since this would have required the prior designation of Collaboration Targets by BMS.

1 unchanged sentence

The potentially dilutive ordinary shares are summarized below:

September 30,

(ordinary shares)

6 unchanged sentences

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