Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | May 04, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2021 | |
Document Transition Report | false | |
Document Quarterly Report | true | |
Entity File Number | 001-37368 | |
Entity Registrant Name | ADAPTIMMUNE THERAPEUTICS PLC | |
Entity Incorporation, State or Country Code | X0 | |
Entity Address, Address Line One | 60 Jubilee Avenue, Milton Park | |
Entity Address, City or Town | Abingdon, Oxfordshire | |
Entity Address, Country | GB | |
Entity Address, Postal Zip Code | OX14 4RX | |
City Area Code | 44 | |
Entity Tax Identification Number | 00-0000000 | |
Title of 12(b) Security | American Depositary Shares, each representing 6 Ordinary Shares, par value £0.001 per share | |
Local Phone Number | 1235 430000 | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Trading Symbol | ADAP | |
Entity Common Stock, Shares Outstanding | 932,984,520 | |
Entity Central Index Key | 0001621227 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
UNAUDITED CONDENSED CONSOLIDATE
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 32,432 | $ 56,882 |
Marketable securities - available-for-sale debt securities | 285,512 | 311,335 |
Other current assets and prepaid expenses | 41,349 | 29,935 |
Total current assets | 359,293 | 398,152 |
Restricted cash | 4,604 | 4,602 |
Operating lease right-of-use assets, net of accumulated amortization | 18,326 | 18,880 |
Property, plant and equipment, net of accumulated depreciation of $32,703 (2020: $31,097) | 27,739 | 27,778 |
Intangibles, net of accumulated amortization | 1,619 | 1,730 |
Total assets | 411,581 | 451,142 |
Current liabilities | ||
Accounts payable | 4,116 | 6,389 |
Operating lease liabilities, current | 2,845 | 2,773 |
Accrued expenses and other accrued liabilities | 22,263 | 27,079 |
Deferred revenue, current | 2,083 | 2,832 |
Total current liabilities | 31,307 | 39,073 |
Operating lease liabilities, non-current | 19,897 | 20,938 |
Deferred revenue, non-current | 50,565 | 49,260 |
Other liabilities, non-current | 655 | 644 |
Total liabilities | 102,424 | 109,915 |
Stockholders' equity | ||
Common stock - Ordinary shares par value ?0.001, 1,038,249,630 authorized and 932,817,168 issued and outstanding (2020: 1,038,249,630 authorized and 928,754,958 issued and outstanding) | 1,331 | 1,325 |
Additional paid in capital | 941,569 | 935,706 |
Accumulated other comprehensive loss | (10,224) | (10,048) |
Accumulated deficit | (623,519) | (585,756) |
Total stockholders' equity | 309,157 | 341,227 |
Total liabilities and stockholders' equity | $ 411,581 | $ 451,142 |
UNAUDITED CONDENSED CONSOLIDA_2
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) $ in Thousands | Mar. 31, 2021USD ($)shares | Mar. 31, 2021£ / shares | Dec. 31, 2020USD ($)shares |
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | |||
Property, plant and equipment, accumulated depreciation | $ | $ 32,703 | $ 31,097 | |
Common stock, par value | £ / shares | £ 0.001 | ||
Common stock, shares authorized | 1,038,249,630 | 1,038,249,630 | |
Common stock, shares issued | 932,817,168 | 928,754,958 | |
Common stock, shares outstanding | 932,817,168 | 928,754,958 |
UNAUDITED CONDENSED CONSOLIDA_3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||
Revenue | $ 434 | $ 761 |
Operating expenses | ||
Research and development | (24,506) | (21,264) |
General and administrative | (13,817) | (9,261) |
Total operating expenses | (38,323) | (30,525) |
Operating loss | (37,889) | (29,764) |
Interest income | 425 | 730 |
Other (expense) income, net | (1) | 937 |
Loss before income taxes | (37,465) | (28,097) |
Income taxes | (298) | (70) |
Net loss attributable to ordinary shareholders | $ (37,763) | $ (28,167) |
Net loss per ordinary share - Basic and diluted | ||
Basic and diluted (in dollars per share) | $ (0.04) | $ (0.04) |
Weighted average shares outstanding: | ||
Basic and diluted (in shares) | 931,088,810 | 739,753,371 |
UNAUDITED CONDENSED CONSOLIDA_4
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | $ (37,763) | $ (28,167) |
Other comprehensive (loss) income, net of tax | ||
Foreign currency translation adjustments, net of tax of $0, $0 and $0 | (3,001) | 17,911 |
Foreign currency gains (losses) on intercompany loan of a long-term investment nature, net of tax of $0 and $0 | 3,048 | (19,651) |
Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $0 and $0 | (223) | (586) |
Total comprehensive loss for the period | $ (37,939) | $ (30,493) |
UNAUDITED CONDENSED CONSOLIDA_5
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Foreign currency translation adjustments, tax | $ 0 | $ 0 |
Foreign currency gains (losses) on intercompany loan of a long-term investment nature, tax | 0 | 0 |
Unrealized holding gains (losses) on available-for-sale debt securities, tax | $ 0 | $ 0 |
UNAUDITED CONDENSED CONSOLIDA_6
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGE IN EQUITY - USD ($) $ in Thousands | Common stock | Additional paid in capital | Accumulated other comprehensive loss | Accumulated deficit | Total |
Balance at the beginning of the period, shares at Dec. 31, 2019 | 631,003,568 | ||||
Balance at the beginning of the period at Dec. 31, 2019 | $ 943 | $ 585,623 | $ (7,264) | $ (455,664) | $ 123,638 |
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of shares upon exercise of stock options | $ 6 | 888 | 894 | ||
Issuance of shares upon exercise of stock options (in shares) | 4,610,772 | ||||
Issuance of shares upon completion of public offering, net of issuance costs | $ 190 | 90,360 | 90,550 | ||
Issuance of shares upon completion of public offering, net of issuance costs (in shares) | 144,900,000 | ||||
Other comprehensive loss | (2,326) | (2,326) | |||
Share-based compensation expense | 1,448 | 1,448 | |||
Net loss | (28,167) | (28,167) | |||
Balance at the end of the period at Mar. 31, 2020 | $ 1,139 | 678,319 | (9,590) | (483,831) | $ 186,037 |
Balance at the end of the period, shares at Mar. 31, 2020 | 780,514,340 | ||||
Balance at the beginning of the period, shares at Dec. 31, 2020 | 928,754,958 | 928,754,958 | |||
Balance at the beginning of the period at Dec. 31, 2020 | $ 1,325 | 935,706 | (10,048) | (585,756) | $ 341,227 |
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of shares upon exercise of stock options | $ 6 | 529 | 535 | ||
Issuance of shares upon exercise of stock options (in shares) | 4,062,210 | ||||
Other comprehensive loss | (176) | (176) | |||
Share-based compensation expense | 5,334 | 5,334 | |||
Net loss | (37,763) | (37,763) | |||
Balance at the end of the period at Mar. 31, 2021 | $ 1,331 | $ 941,569 | $ (10,224) | $ (623,519) | $ 309,157 |
Balance at the end of the period, shares at Mar. 31, 2021 | 932,817,168 | 932,817,168 |
UNAUDITED CONDENSED CONSOLIDA_7
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (37,763) | $ (28,167) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,436 | 1,711 |
Share-based compensation expense | 5,334 | 1,448 |
Unrealized foreign exchange (gains) losses | 1,249 | (1,745) |
Amortization (accretion) on available-for-sale debt securities | 1,499 | 150 |
Other | 1,299 | 175 |
Changes in operating assets and liabilities: | ||
Increase in receivables and other operating assets | (11,155) | (3,193) |
Increase in non-current operating assets | (259) | |
Decrease in payables and other current liabilities | (8,601) | (2,708) |
Increase in deferred revenue | 162 | 49,445 |
Net cash (used in) provided by operating activities | (46,540) | 16,857 |
Cash flows from investing activities | ||
Acquisition of property, plant and equipment | (1,152) | (192) |
Acquisition of intangibles | (133) | (152) |
Maturity or redemption of marketable securities | 84,646 | 26,364 |
Investment in marketable securities | (61,599) | (97,967) |
Net cash provided by (used in) investing activities | 21,762 | (71,947) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 90,550 | |
Proceeds from exercise of stock options | 534 | 894 |
Net cash provided by financing activities | 534 | 91,444 |
Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (204) | (502) |
Net increase (decrease) in cash, cash equivalents and restricted cash | (24,448) | 35,852 |
Cash, cash equivalents and restricted cash at start of period | 61,484 | 54,908 |
Cash, cash equivalents and restricted cash at end of period | $ 37,036 | $ 90,760 |
General
General | 3 Months Ended |
Mar. 31, 2021 | |
General | |
General | Note 1 — General Adaptimmune Therapeutics plc is registered in England and Wales. Its registered office is 60 Jubilee Avenue, Milton Park, Abingdon, Oxfordshire, OX14 4RX, United Kingdom. Adaptimmune Therapeutics plc and its subsidiaries (collectively “Adaptimmune” or the “Company”) is a clinical-stage biopharmaceutical company primarily focused on providing novel cell therapies to people with cancer. We are a leader in the development of T-cell therapies for solid tumors. The Company’s The Company is subject to a number of risks similar to other biopharmaceutical companies in the early stage of clinical development including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical programs or clinical programs, the need to obtain marketing approval for its cell therapies, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of its cell therapies, the need to develop a reliable commercial manufacturing process, the need to commercialize any cell therapies that may be approved for marketing, and protection of proprietary technology. If the Company does not successfully commercialize any of its cell therapies, it will be unable to generate product revenue or achieve profitability. The Company had an accumulated deficit of |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2 — Summary of Significant Accounting Policies (a) Basis of presentation The condensed consolidated financial statements of Adaptimmune Therapeutics plc and its subsidiaries and other financial information included in this Quarterly Report are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation. The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on February 25, 2021 (the “Annual Report”). The balance sheet as of December 31, 2020 was derived from audited consolidated financial statements included in the Company’s Annual Report but does not include all disclosures required by U.S. GAAP. The Company’s significant accounting policies are described in Note 2 to those consolidated financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year. (b) Use of estimates in interim financial statements The preparation of interim financial statements, in conformity with U.S. GAAP and SEC regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the interim financial statements and reported amounts of revenues and expenses during the reporting period. Estimates and assumptions are primarily made in relation to valuation allowances relating to deferred tax assets, revenue recognition, and estimation of the incremental borrowing rate for operating leases. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate. (c) Fair value measurements The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The hierarchy defines three levels of valuation inputs: Level 1 - Quoted prices in active markets for identical assets or liabilities Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly Level 3 - Unobservable inputs that reflect the Company's own assumptions about the assumptions market participants would use in pricing the asset or liability The carrying amounts of the Company’s cash and cash equivalents, restricted cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the short-term nature of these instruments. The fair value of marketable securities, which are measured at fair value on a recurring basis is detailed in Note 6, Fair value measurements. (d ) New accounting pronouncements Adopted in the period Convertible instruments and contracts in an entity’s own stock On January 1, 2021, the Company adopted ASU 2020-06 - Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity's Own Equity (Subtopic 815-40)—Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, To be adopted in future periods Measurement of credit losses on financial instruments In June 2016, the FASB issued ASU 2016-13 - Financial Instruments - Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance is effective for the fiscal year beginning January 1, 2020, including interim periods within that fiscal year. In November 2019, the FASB issued ASU 2019-10 which resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies (as defined by the SEC), including the Company, at that time to the fiscal year beginning January 1, 2023; however, earlier adoption is permitted, and the Company may choose to implement the guidance in an earlier fiscal year. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its condensed consolidated financial statements. |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2021 | |
Revenue | |
Revenue | Note 3 — Revenue The Company has two contracts with customers: a collaboration and license agreement with GSK and a collaboration agreement with Astellas. Revenue comprises the following categories (in thousands): Three months ended March 31, 2021 2020 Development revenue $ 434 $ 761 $ 434 $ 761 The amount of the transaction price that is allocated to performance obligations that are unsatisfied or partially satisfied under the agreement as of March 31, 2021 was $64,137,000. Of this, $15,300,000 is allocated to the rights granted for each of the two independent Astellas targets, $7,400,000 is allocated to research services and rights second third Future development, regulatory and sales milestones under both agreements are not considered probable as of March 31, 2021 and have not been included in the transaction price. Reimbursement of the research funding over the co-development period under the Astellas agreement is variable consideration and included in the transaction price as of March 31, 2021 to the extent that a significant reversal of revenue is not probable. The Company expects to recognize revenue for the two independent Astellas targets at a point-in-time upon commencement of the licenses in the event of nomination of the targets, while revenue for the remaining performance obligations will be recognized as development progresses. |
Loss per share
Loss per share | 3 Months Ended |
Mar. 31, 2021 | |
Loss per share | |
Loss per share | Note 4 — Loss per share The dilutive effect of 113,556,283 and 93,106,607 stock options outstanding as of March 31, 2021 and 2020 respectively have been excluded from the diluted loss per share calculation for the three months ended March 31, 2021 and 2020, because they would have an antidilutive effect on the loss per share for the period. |
Fair value measurements
Fair value measurements | 3 Months Ended |
Mar. 31, 2021 | |
Fair value measurements | |
Fair value measurements | Note 6 — Fair value measurements Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of March 31, 2021 are as follows (in thousands): Fair value measurements using March 31, Level 1 Level 2 Level 3 2021 Assets: Corporate debt securities $ 279,507 $ 279,507 — — Agency bonds 6,005 — 6,005 — $ 285,512 $ 279,507 $ 6,005 $ — The Company estimates the fair value of available-for-sale debt securities with the aid of a third party valuation service, which uses actual trade and indicative prices sourced from third-party providers on a daily basis to estimate the fair value. If observed market prices are not available (for example securities with short maturities and infrequent secondary market trades), the securities are priced using a valuation model maximizing observable inputs, including market interest rates. |
Marketable securities - availab
Marketable securities - available-for-sale debt securities | 3 Months Ended |
Mar. 31, 2021 | |
Marketable securities - available-for-sale debt securities | |
Marketable securities - available-for-sale debt securities | Note 7 — Marketable securities – available-for-sale debt securities As of March 31, 2021, the Company has the following investments in marketable securities (in thousands): Gross Gross Aggregate Remaining Amortized Unrealized Unrealized Estimated Contractual Maturity Cost Gains Losses Fair Value Available-for-sale debt securities: Corporate debt securities Less than 3 months $ 54,372 $ 15 $ (11) $ 54,376 Corporate debt securities 3 months to 1 year 114,136 35 (39) 114,132 Agency bonds 1 year to 2 years 5,999 6 — 6,005 Corporate debt securities 1 year to 2 years 111,119 53 (173) 110,999 $ 285,626 $ 109 $ (223) $ 285,512 The aggregate fair value (in thousands) and number of securities held by the Company (including those classified as cash equivalents) in an unrealized loss position as of March 31, 2021 and 31 December, 2020 are as follows: March 31, 2021 December 31, 2020 Fair market value of investments in an unrealized loss position Number of investments in an unrealized loss position Unrealized losses Fair market value of investments in an unrealized loss position Number of investments in an unrealized loss position Unrealized losses Marketable securities: Corporate debt securities $ 199,148 37 $ (223) $ 157,985 30 $ (158) As of March 31, 2021, the securities in an unrealized loss position are not considered to be other than temporarily impaired because the impairments are not severe and have been for a short duration. No securities have been in an unrealized loss position for more than one year. The Company does not intend to sell the debt securities in an unrealized loss position and believes that it has the ability to hold the debt securities to maturity. |
Other current assets
Other current assets | 3 Months Ended |
Mar. 31, 2021 | |
Other current assets | |
Other current assets | Note 8 — Other current assets Other current assets consisted of the following (in thousands): March 31, December 31, 2021 2020 Corporate tax receivable $ 31,141 $ 20,585 Prepayments 5,689 6,314 Clinical materials 1,576 2,086 Other current assets 2,943 950 $ 41,349 $ 29,935 |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 3 Months Ended |
Mar. 31, 2021 | |
Accrued expenses and other current liabilities | |
Accrued expenses and other current liabilities | Note 9 — Accrued expenses and other current liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): March 31, December 31, 2021 2020 Accrued clinical and development expenditure $ 13,577 $ 13,081 Accrued employee expenses 5,836 11,825 Other accrued expenditure 2,459 2,126 Other 391 47 $ 22,263 $ 27,079 |
Contingencies and commitments
Contingencies and commitments | 3 Months Ended |
Mar. 31, 2021 | |
Contingencies and commitments | |
Contingencies and commitments | Note 10 — Contingencies and commitments On January 7, 2021, the Company entered into an agreement with a third party, whereby the third party is responsible for the development, manufacture, submission of regulatory filings and commercialization of a companion diagnostic for the detection of the MAGE-A4 biomarker. The Company shall compensate the third party for its performance of activities under the agreement based on milestone payments and reimbursement of direct expenses. The agreement is non-exclusive and the third party can sell the companion diagnostic to other parties. Once the companion diagnostic is approved and launched, the Company guarantees a minimum revenue to the third party. The agreement can be terminated by the Company and the third party upon 60 days’ notice, if certain conditions are met. |
Share-based compensation
Share-based compensation | 3 Months Ended |
Mar. 31, 2021 | |
Share-based compensation | |
Share-based compensation | Note 11 — Share-based compensation The following table shows the total share-based compensation expense included in the unaudited consolidated statements of operations (in thousands): Three months ended March 31, 2021 2020 Research and development $ 2,375 $ 978 General and administrative 2,959 470 $ 5,334 $ 1,448 The following table shows information about share options and options which have a nominal exercise price (similar to restricted stock units (RSUs)) granted: Three months ended March 31, 2021 2020 Number of options over ordinary shares granted 14,803,056 10,229,280 Weighted average fair value of ordinary shares options $ 0.75 $ 0.51 Number of additional options with a nominal exercise price granted 12,663,792 6,060,696 Weighted average fair value of options with a nominal exercise price $ 1.03 $ 0.74 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Summary of Significant Accounting Policies | |
Basis of presentation | (a) Basis of presentation The condensed consolidated financial statements of Adaptimmune Therapeutics plc and its subsidiaries and other financial information included in this Quarterly Report are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation. The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on February 25, 2021 (the “Annual Report”). The balance sheet as of December 31, 2020 was derived from audited consolidated financial statements included in the Company’s Annual Report but does not include all disclosures required by U.S. GAAP. The Company’s significant accounting policies are described in Note 2 to those consolidated financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year. |
Use of estimates in financial statements | (b) Use of estimates in interim financial statements The preparation of interim financial statements, in conformity with U.S. GAAP and SEC regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the interim financial statements and reported amounts of revenues and expenses during the reporting period. Estimates and assumptions are primarily made in relation to valuation allowances relating to deferred tax assets, revenue recognition, and estimation of the incremental borrowing rate for operating leases. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate. |
Fair value measurements | (c) Fair value measurements The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The hierarchy defines three levels of valuation inputs: Level 1 - Quoted prices in active markets for identical assets or liabilities Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly Level 3 - Unobservable inputs that reflect the Company's own assumptions about the assumptions market participants would use in pricing the asset or liability The carrying amounts of the Company’s cash and cash equivalents, restricted cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the short-term nature of these instruments. The fair value of marketable securities, which are measured at fair value on a recurring basis is detailed in Note 6, Fair value measurements. |
New accounting pronouncements | (d ) New accounting pronouncements Adopted in the period Convertible instruments and contracts in an entity’s own stock On January 1, 2021, the Company adopted ASU 2020-06 - Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity's Own Equity (Subtopic 815-40)—Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, To be adopted in future periods Measurement of credit losses on financial instruments In June 2016, the FASB issued ASU 2016-13 - Financial Instruments - Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance is effective for the fiscal year beginning January 1, 2020, including interim periods within that fiscal year. In November 2019, the FASB issued ASU 2019-10 which resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies (as defined by the SEC), including the Company, at that time to the fiscal year beginning January 1, 2023; however, earlier adoption is permitted, and the Company may choose to implement the guidance in an earlier fiscal year. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its condensed consolidated financial statements. |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Revenue | |
Summary of revenue categories | Revenue comprises the following categories (in thousands): Three months ended March 31, 2021 2020 Development revenue $ 434 $ 761 $ 434 $ 761 |
Accumulated other comprehensive
Accumulated other comprehensive income (loss) (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accumulated other comprehensive income (loss) | |
Schedule of changes in Accumulated other comprehensive (loss) income | The following table shows the changes in Accumulated other comprehensive (loss) income (in thousands): Accumulated Accumulated Total foreign unrealized accumulated currency gains (losses) on other translation available-for-sale comprehensive adjustments debt securities (loss) income Balance at January 1, 2021 $ (10,158) $ 110 $ (10,048) Foreign currency translation adjustments (3,001) — (3,001) Foreign currency gains on intercompany loan of a long-term investment nature, net of tax of $0 3,048 — 3,048 Unrealized holding losses on available-for-sale debt securities, net of tax of $0 — (223) (223) Balance at March 31, 2021 $ (10,111) $ (113) $ (10,224) Accumulated Accumulated Total foreign unrealized accumulated currency gains (losses) on other translation available-for-sale comprehensive adjustments debt securities (loss) income Balance at January 1, 2020 $ (7,302) $ 38 $ (7,264) Foreign currency translation adjustments 17,911 — 17,911 Foreign currency losses on intercompany loan of a long-term investment nature, net of tax of $0 (19,651) — (19,651) Unrealized holding losses on available-for-sale debt securities, net of tax of $0 — (586) (586) Balance at March 31, 2020 $ (9,042) $ (548) $ (9,590) |
Fair value measurements (Tables
Fair value measurements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Fair value measurements | |
Summary of fair value of assets and liabilities on a recurring basis based on fair value measurement criteria | Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of March 31, 2021 are as follows (in thousands): Fair value measurements using March 31, Level 1 Level 2 Level 3 2021 Assets: Corporate debt securities $ 279,507 $ 279,507 — — Agency bonds 6,005 — 6,005 — $ 285,512 $ 279,507 $ 6,005 $ — |
Marketable securities - avail_2
Marketable securities - available-for-sale debt securities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Marketable securities - available-for-sale debt securities | |
Schedule of investments in marketable securities | As of March 31, 2021, the Company has the following investments in marketable securities (in thousands): Gross Gross Aggregate Remaining Amortized Unrealized Unrealized Estimated Contractual Maturity Cost Gains Losses Fair Value Available-for-sale debt securities: Corporate debt securities Less than 3 months $ 54,372 $ 15 $ (11) $ 54,376 Corporate debt securities 3 months to 1 year 114,136 35 (39) 114,132 Agency bonds 1 year to 2 years 5,999 6 — 6,005 Corporate debt securities 1 year to 2 years 111,119 53 (173) 110,999 $ 285,626 $ 109 $ (223) $ 285,512 |
Schedule of aggregate fair value | The aggregate fair value (in thousands) and number of securities held by the Company (including those classified as cash equivalents) in an unrealized loss position as of March 31, 2021 and 31 December, 2020 are as follows: March 31, 2021 December 31, 2020 Fair market value of investments in an unrealized loss position Number of investments in an unrealized loss position Unrealized losses Fair market value of investments in an unrealized loss position Number of investments in an unrealized loss position Unrealized losses Marketable securities: Corporate debt securities $ 199,148 37 $ (223) $ 157,985 30 $ (158) |
Other current assets (Tables)
Other current assets (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Other current assets | |
Summary of other current assets | Other current assets consisted of the following (in thousands): March 31, December 31, 2021 2020 Corporate tax receivable $ 31,141 $ 20,585 Prepayments 5,689 6,314 Clinical materials 1,576 2,086 Other current assets 2,943 950 $ 41,349 $ 29,935 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accrued expenses and other current liabilities | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): March 31, December 31, 2021 2020 Accrued clinical and development expenditure $ 13,577 $ 13,081 Accrued employee expenses 5,836 11,825 Other accrued expenditure 2,459 2,126 Other 391 47 $ 22,263 $ 27,079 |
Share-based compensation (Table
Share-based compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share-based compensation | |
Summary of share-based compensation expense included in the consolidated statements of operations | The following table shows the total share-based compensation expense included in the unaudited consolidated statements of operations (in thousands): Three months ended March 31, 2021 2020 Research and development $ 2,375 $ 978 General and administrative 2,959 470 $ 5,334 $ 1,448 |
Summary of all stock option activity | The following table shows information about share options and options which have a nominal exercise price (similar to restricted stock units (RSUs)) granted: Three months ended March 31, 2021 2020 Number of options over ordinary shares granted 14,803,056 10,229,280 Weighted average fair value of ordinary shares options $ 0.75 $ 0.51 Number of additional options with a nominal exercise price granted 12,663,792 6,060,696 Weighted average fair value of options with a nominal exercise price $ 1.03 $ 0.74 |
General (Details)
General (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
General | ||
Accumulated deficit | $ 623,519 | $ 585,756 |
Revenue - Revenue from contract
Revenue - Revenue from contracts with customers (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021USD ($)customer | Mar. 31, 2020USD ($) | |
Revenue | ||
Revenue | $ 434 | $ 761 |
Number of contracts with customers | customer | 2 | |
Increase in deferred revenue | $ 162 | 49,445 |
Development revenue | ||
Revenue | ||
Revenue | $ 434 | $ 761 |
Revenue - Collaboration Agreeme
Revenue - Collaboration Agreement - Performance obligations (Details) | 3 Months Ended |
Mar. 31, 2021USD ($)item | |
Astellas Collaboration Agreement | |
Performance obligations | |
Number of co-development targets | 3 |
Number of independent targets | item | 2 |
Amount of transaction price allocated to performance obligation that has not been recognized as revenue | $ 64,137,000 |
Astellas Collaboration Agreement | Rights granted, first independent target | |
Performance obligations | |
Amount of transaction price allocated to performance obligation that has not been recognized as revenue | 15,300,000 |
Astellas Collaboration Agreement | Rights granted, second independent target | |
Performance obligations | |
Amount of transaction price allocated to performance obligation that has not been recognized as revenue | 15,300,000 |
Astellas Collaboration Agreement | Research services and rights granted under the co-exclusive license, first co-development target | |
Performance obligations | |
Amount of transaction price allocated to performance obligation that has not been recognized as revenue | 18,500,000 |
Astellas Collaboration Agreement | Research services and rights under the co-exclusive license, second co-development target | |
Performance obligations | |
Amount of transaction price allocated to performance obligation that has not been recognized as revenue | 7,400,000 |
Astellas Collaboration Agreement | Research services and rights under the co-exclusive license, third co-development target | |
Performance obligations | |
Amount of transaction price allocated to performance obligation that has not been recognized as revenue | 7,400,000 |
GSK Collaboration And License Agreement | Research services for the third target under the agreement with GSK | |
Performance obligations | |
Amount of transaction price allocated to performance obligation that has not been recognized as revenue | $ 237,000 |
Loss per share - Antidilutive s
Loss per share - Antidilutive shares (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share options | ||
Antidilutive securities | ||
Potentially dilutive equity instruments excluded from the diluted loss per share (in shares) | 113,556,283 | 93,106,607 |
Accumulated other comprehensi_2
Accumulated other comprehensive income (loss) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Accumulated other comprehensive loss | ||
Total accumulated other comprehensive (loss) income | $ (10,048) | |
Foreign currency translation adjustments, net of tax of $0, $0 and $0 | (3,001) | $ 17,911 |
Foreign currency gains (losses) on intercompany loan of a long-term investment nature, net of tax of $0 and $0 | 3,048 | (19,651) |
Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $0 and $0 | (223) | (586) |
Total accumulated other comprehensive (loss) income | (10,224) | |
Accumulated other comprehensive loss (paranthetical) | ||
Foreign currency gains (losses) on intercompany loan of a long-term investment nature, tax | 0 | 0 |
Unrealized holding gains (losses) on available-for-sale debt securities, tax | 0 | 0 |
Accumulated foreign currency translation adjustments | ||
Accumulated other comprehensive loss | ||
Total accumulated other comprehensive (loss) income | (10,158) | (7,302) |
Foreign currency translation adjustments, net of tax of $0, $0 and $0 | (3,001) | 17,911 |
Foreign currency gains (losses) on intercompany loan of a long-term investment nature, net of tax of $0 and $0 | 3,048 | (19,651) |
Total accumulated other comprehensive (loss) income | (10,111) | (9,042) |
Accumulated unrealized gains (losses) on available-for-sale debt securities | ||
Accumulated other comprehensive loss | ||
Total accumulated other comprehensive (loss) income | 110 | 38 |
Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $0 and $0 | (223) | (586) |
Total accumulated other comprehensive (loss) income | (113) | (548) |
Accumulated other comprehensive loss | ||
Accumulated other comprehensive loss | ||
Total accumulated other comprehensive (loss) income | (10,048) | (7,264) |
Foreign currency translation adjustments, net of tax of $0, $0 and $0 | (3,001) | 17,911 |
Foreign currency gains (losses) on intercompany loan of a long-term investment nature, net of tax of $0 and $0 | 3,048 | (19,651) |
Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $0 and $0 | (223) | (586) |
Total accumulated other comprehensive (loss) income | $ (10,224) | $ (9,590) |
Fair value measurements (Detail
Fair value measurements (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Marketable securities: | ||
Available-for-sale securities, Debt Securities, Current, Total | $ 285,512 | $ 311,335 |
Recurring basis | ||
Marketable securities: | ||
Available-for-sale securities, Debt Securities, Current, Total | 285,512 | |
Recurring basis | Corporate debt securities | ||
Marketable securities: | ||
Available-for-sale securities, Debt Securities, Current, Total | 279,507 | |
Recurring basis | Agency bonds | ||
Marketable securities: | ||
Available-for-sale securities, Debt Securities, Current, Total | 6,005 | |
Recurring basis | Level 1 | ||
Marketable securities: | ||
Available-for-sale securities, Debt Securities, Current, Total | 279,507 | |
Recurring basis | Level 1 | Corporate debt securities | ||
Marketable securities: | ||
Available-for-sale securities, Debt Securities, Current, Total | 279,507 | |
Recurring basis | Level 2 | ||
Marketable securities: | ||
Available-for-sale securities, Debt Securities, Current, Total | 6,005 | |
Recurring basis | Level 2 | Agency bonds | ||
Marketable securities: | ||
Available-for-sale securities, Debt Securities, Current, Total | $ 6,005 |
Marketable securities - Avail_3
Marketable securities - Available-for-sale debt securities (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Debt Securities | |
Marketable securities | |
Amortized cost | $ 285,626 |
Gross unrealized gains | 109 |
Gross unrealized losses | (223) |
Aggregate estimated fair value | 285,512 |
Corporate Debt Securities Maturity Period Less Than Three Months | Debt Securities | |
Marketable securities | |
Amortized cost | 54,372 |
Gross unrealized gains | 15 |
Gross unrealized losses | (11) |
Aggregate estimated fair value | 54,376 |
Corporate Debt Securities Maturity Period Three Months To One Year | |
Marketable securities | |
Amortized cost | 114,136 |
Gross unrealized gains | 35 |
Gross unrealized losses | (39) |
Aggregate estimated fair value | 114,132 |
Corporate Debt Securities Maturity Period One Year To Two Years | Debt Securities | |
Marketable securities | |
Amortized cost | 111,119 |
Gross unrealized gains | 53 |
Gross unrealized losses | (173) |
Aggregate estimated fair value | 110,999 |
Agency Bond Maturity Period One Year To Two Years | Marketable securities | |
Marketable securities | |
Amortized cost | 5,999 |
Gross unrealized gains | 6 |
Aggregate estimated fair value | $ 6,005 |
Minimum | Corporate Debt Securities Maturity Period One Year or Less | Debt Securities | |
Marketable securities | |
Available For Sale Securities Debt Maturity Period | 3 months |
Minimum | Corporate Debt Securities Maturity Period One Year To Two Years | Debt Securities | |
Marketable securities | |
Available For Sale Securities Debt Maturity Period | 1 year |
Minimum | Agency Bond Maturity Period One Year To Two Years | Marketable securities | |
Marketable securities | |
Available For Sale Securities Debt Maturity Period | 1 year |
Maximum | Corporate Debt Securities Maturity Period Less Than Three Months | Debt Securities | |
Marketable securities | |
Available For Sale Securities Debt Maturity Period | 3 months |
Maximum | Corporate Debt Securities Maturity Period One Year or Less | Debt Securities | |
Marketable securities | |
Available For Sale Securities Debt Maturity Period | 1 year |
Maximum | Corporate Debt Securities Maturity Period One Year To Two Years | Debt Securities | |
Marketable securities | |
Available For Sale Securities Debt Maturity Period | 2 years |
Maximum | Agency Bond Maturity Period One Year To Two Years | Marketable securities | |
Marketable securities | |
Available For Sale Securities Debt Maturity Period | 2 years |
Marketable securities - Avail_4
Marketable securities - Available-for-sale debt securities - Unrealized loss position (Details) $ in Thousands | Mar. 31, 2021USD ($)security | Dec. 31, 2020USD ($) |
Marketable securities | ||
Number of available-for-sale securities in an unrealized loss position for more than one year | security | 0 | |
Corporate debt securities | Debt Securities | ||
Marketable securities | ||
Fair market value of investments in an unrealized loss position | $ 199,148 | $ 157,985 |
Number of investments in an unrealized loss position | 37 | 30 |
Unrealized losses | $ (223) | $ (158) |
Other current assets (Details)
Other current assets (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Other current assets | ||
Corporate tax receivable | $ 31,141 | $ 20,585 |
Prepayments | 5,689 | 6,314 |
Clinical materials | 1,576 | 2,086 |
Other current assets | 2,943 | 950 |
Total | $ 41,349 | $ 29,935 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Accrued expenses and other current liabilities | ||
Accrued clinical and development expenditure | $ 13,577 | $ 13,081 |
Accrued employee expenses | 5,836 | 11,825 |
Other accrued expenditure | 2,459 | 2,126 |
Other | 391 | 47 |
Total | $ 22,263 | $ 27,079 |
Share-based compensation - Shar
Share-based compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Total share-based compensation expense included in the consolidated statements of operations | ||
Total share-based compensation expense | $ 5,334 | $ 1,448 |
Research and development | ||
Total share-based compensation expense included in the consolidated statements of operations | ||
Total share-based compensation expense | 2,375 | 978 |
General and administrative | ||
Total share-based compensation expense included in the consolidated statements of operations | ||
Total share-based compensation expense | $ 2,959 | $ 470 |
Share-based compensation - Opti
Share-based compensation - Options (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based compensation | ||
Number of options granted (in shares) | 14,803,056 | 10,229,280 |
Weighted average fair value (in dollars per share) | $ 0.75 | $ 0.51 |
Number of additional options with a nominal exercise price granted | 12,663,792 | 6,060,696 |
Weighted average fair value of RSU-style options granted | $ 1.03 | $ 0.74 |