UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
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TABLE OF CONTENTS
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General information
In this Quarterly Report on Form 10-Q (“Quarterly Report”), “Adaptimmune,” the “Group,” the “Company,” “we,” “us” and “our” refer to Adaptimmune Therapeutics plc and its consolidated subsidiaries, except where the context otherwise requires.
Information Regarding Forward-Looking Statements
This Quarterly Report contains forward-looking statements that are based on our current expectations, assumptions, estimates and projections about us and our industry. All statements other than statements of historical fact in this Quarterly Report are forward-looking statements.
These forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause our actual results of operations, financial condition, liquidity, performance, prospects, opportunities, achievements or industry results, as well as those of the markets we serve or intend to serve, to differ materially from those expressed in, or suggested by, these forward-looking statements. These forward-looking statements are based on assumptions regarding our present and future business strategies and the environment in which we expect to operate in the future. Important factors that could cause those differences include, but are not limited to:
● | our ability to progress and continue with business operations as a result of the outbreak of coronavirus, SARS-CoV-2 (“COVID-19”) including our ability to treat and enroll patients in clinical trials, manufacture cell therapies for patients, obtain responses and approvals from regulatory authorities, progress third party relationships and collaborations, obtain and publish data from our clinical trials and source and procure resources and supplies needed for ongoing activities; |
● | our ability to successfully advance our ADP-A2M4 (MAGE-A4), ADP-A2M4CD8 (MAGE-A4CD8) and ADP-A2AFP (AFP) products through clinical development and the timing within which we can recruit and treat patients in all of our clinical trials; |
● | our ability to continue to fund our operations including as a result of the impact of the COVID-19 pandemic; |
● | our ability to successfully and reproducibly manufacture SPEAR T-cells and other cell therapies in order to meet patient demand; |
● | our ability to further develop our commercial manufacturing process for our SPEAR T-cells and other cell therapies, transfer such commercial process to third party contract manufacturers, if required, and for such third party contract manufacturers or ourselves to manufacture SPEAR T-cells to the quality and on the timescales we require; |
● | our ability to successfully advance our SPEAR T-cell technology platform, to improve the safety and effectiveness of our existing SPEAR T-cell candidates, to identify and develop new cell therapies and to submit Investigational New Drug Applications, or INDs, for new cell therapies; |
● | the rate and degree of market acceptance of cell therapy generally, and of our particular cell therapies including our SPEAR T-cells; |
● | government regulation and approval, including, but not limited to, the expected regulatory approval timelines for our SPEAR T-cells and the level of pricing and reimbursement for our SPEAR T-cells, if approved for marketing; |
● | our ability to successfully commercialize any products; |
● | the existence of any third-party patents preventing further development of any of our cell therapies, including, any inability to obtain appropriate third party licenses, or enforcement of patents against us or our collaborators; |
● | our ability to obtain granted patents covering our cell therapies and to enforce such patents against third parties; |
● | volatility in equity markets in general, and in the biopharmaceutical sector in particular; |
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● | fluctuations in the price of materials and bought-in components; |
● | the scope and timing of performance of our ongoing collaborations with GlaxoSmithKline (“GSK”) and with Astellas Pharma Inc. through its wholly-owned subsidiary Universal Cells Inc. (“Astellas”); |
● | our relationships with suppliers, contract manufacturing organizations or CROs and other third-party providers including fluctuations in the price of materials and services, ability to obtain reagents particularly where such reagents are only available from a single source, and performance of third party providers; |
● | increased competition from other companies in the biotechnology and pharmaceutical industries including where such competition impacts ability to recruit patients into clinical trials; |
● | claims for personal injury or death arising from the use of our cell therapies; |
● | our ability to attract and retain qualified personnel; and |
● | additional factors that are not known to us at this time. |
Additional factors that could cause actual results, financial condition, liquidity, performance, prospects, opportunities, achievements or industry results to differ materially include, but are not limited to, those discussed under “Risk Factors” in Part II, Item 1A in this Quarterly Report and in our other filings with the Securities and Exchange Commission (the “SEC”). Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this Quarterly Report not to occur. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar words are intended to identify estimates and forward-looking statements. Estimates and forward-looking statements speak only at the date they were made, and we undertake no obligation to update or to review any estimate and/or forward-looking statement because of new information, future events or other factors. Estimates and forward-looking statements involve risks and uncertainties and are not guarantees of future performance. Our future results may differ materially from those expressed in these estimates and forward-looking statements. In light of the risks and uncertainties described above, the estimates and forward-looking statements discussed in this Quarterly Report might not occur, and our future results and our performance may differ materially from those expressed in these forward-looking statements due to, inclusive of, but not limited to, the factors mentioned above. Because of these uncertainties, you should not make any investment decision based on these estimates and forward-looking statements.
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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements.
ADAPTIMMUNE THERAPEUTICS PLC
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
June 30, | December 31, | |||||
| 2020 |
| 2019 | |||
Assets | ||||||
Current assets | ||||||
Cash and cash equivalents | $ | | $ | | ||
Marketable securities - available-for-sale debt securities | | | ||||
Other current assets and prepaid expenses (including current portion of clinical materials) | | | ||||
Total current assets | | | ||||
Restricted cash | | | ||||
Clinical materials | | | ||||
Operating lease right-of-use assets, net of accumulated amortization | | | ||||
Property, plant and equipment, net of accumulated depreciation of $ | | | ||||
Intangibles, net of accumulated amortization | | | ||||
Total assets | $ | | $ | | ||
Liabilities and stockholders’ equity | ||||||
Current liabilities | ||||||
Accounts payable | $ | | $ | | ||
Operating lease liabilities, current | | | ||||
Accrued expenses and other accrued liabilities | | | ||||
Deferred revenue, current | | | ||||
Total current liabilities | | | ||||
Operating lease liabilities, non-current | | | ||||
Deferred revenue, non-current | | — | ||||
Other liabilities, non-current | | | ||||
Total liabilities | | | ||||
Stockholders’ equity | ||||||
Common stock - Ordinary shares par value £ | | | ||||
Additional paid in capital | | | ||||
Accumulated other comprehensive loss | ( | ( | ||||
Accumulated deficit | ( | ( | ||||
Total stockholders' equity | | | ||||
Total liabilities and stockholders’ equity | $ | | $ | |
See accompanying notes to unaudited condensed consolidated financial statements.
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ADAPTIMMUNE THERAPEUTICS PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
Three months ended |
| Six months ended | |||||||||||
June 30, | June 30, | ||||||||||||
| 2020 |
| 2019 |
| 2020 |
| 2019 | ||||||
Revenue | $ | | $ | | $ | | $ | | |||||
Operating expenses | |||||||||||||
Research and development | ( | ( |
| ( |
| ( | |||||||
General and administrative | ( | ( |
| ( |
| ( | |||||||
Total operating expenses | ( | ( | ( |
| ( | ||||||||
Operating loss | ( | ( |
| ( |
| ( | |||||||
Interest income | | |
| |
| | |||||||
Other (expense) income, net | ( | ( |
| |
| ( | |||||||
Loss before income taxes | ( | ( |
| ( |
| ( | |||||||
Income taxes | ( | ( |
| ( |
| ( | |||||||
Net loss attributable to ordinary shareholders | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Net loss per ordinary share | |||||||||||||
Basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Weighted average shares outstanding: | |||||||||||||
Basic and diluted | | |
| |
| | |||||||
See accompanying notes to unaudited condensed consolidated financial statements.
6
ADAPTIMMUNE THERAPEUTICS PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands)
Three months ended | Six months ended | ||||||||||||
June 30, | June 30, | ||||||||||||
| 2020 |
| 2019 | 2020 |
| 2019 | |||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Other comprehensive income (loss), net of tax | |||||||||||||
Foreign currency translation adjustments, net of tax of $ | | | | | |||||||||
Foreign currency losses on intercompany loan of a long-term investment nature, net of tax of $ | ( | — | ( | — | |||||||||
Unrealized gains on available-for-sale debt securities | |||||||||||||
Unrealized holding gains on available-for-sale debt securities, net of tax of $ | | | | | |||||||||
Reclassification adjustment for gains on available-for-sale debt securities included in net loss, net of tax of $ | — | ( | — | ( | |||||||||
Total comprehensive loss for the period | $ | ( | $ | ( | $ | ( | $ | ( |
See accompanying notes to unaudited condensed consolidated financial statements.
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ADAPTIMMUNE THERAPEUTICS PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGE IN EQUITY
(In thousands, except share data)
Accumulated other | ||||||||||||||||||||
comprehensive loss | ||||||||||||||||||||
Accumulated | ||||||||||||||||||||
unrealized | ||||||||||||||||||||
Accumulated | (losses) | |||||||||||||||||||
foreign | gains on | |||||||||||||||||||
Additional | currency | available-for- | Total | |||||||||||||||||
Common | Common | paid in | translation | sale debt | Accumulated | stockholders' | ||||||||||||||
| stock |
| stock |
| capital |
| adjustments |
| securities |
| deficit |
| equity | |||||||
Balance as of 1 January 2020 | | $ | | $ | | $ | ( | $ | | $ | ( | $ | | |||||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Issuance of shares upon exercise of stock options |
| |
| |
| |
| — |
| — |
| — |
| | ||||||
Issuance of shares upon completion of public offering, net of issuance costs | | | | — | — | — | | |||||||||||||
Other comprehensive loss | ||||||||||||||||||||
Foreign currency translation adjustments |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
Foreign currency losses on intercompany loan of a long-term investment nature, net of tax of $- | — | — | — | ( | — | — | ( | |||||||||||||
Unrealized holding losses on available-for-sale debt securities, net of tax of $- |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
Share-based compensation expense |
| — |
| — |
| |
| — |
| — |
| — |
| | ||||||
Balance as of March 31, 2020 |
| | $ | | $ | | $ | ( | $ | ( | $ | ( | $ | | ||||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Issuance of shares upon exercise of stock options |
| |
| |
| |
| — |
| — |
| — |
| | ||||||
Issuance of shares upon completion of public offering, net of issuance costs | | | | — | — | — | | |||||||||||||
Other comprehensive income | ||||||||||||||||||||
Foreign currency translation adjustments |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
Foreign currency losses on intercompany loan of a long-term investment nature, net of tax of $- | — | — | — | ( | — | — | ( | |||||||||||||
Unrealized holding gains on available-for-sale debt securities, net of tax of $- |
| — |
| — |
| — |
| — |
| |
| — |
| | ||||||
Share-based compensation expense |
| — |
| — |
| |
| — |
| — |
| — |
| | ||||||
Balance as of June 30, 2020 |
| | $ | | $ | | $ | ( | $ | | $ | ( | $ | |
See accompanying notes to unaudited condensed consolidated financial statements.
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ADAPTIMMUNE THERAPEUTICS PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGE IN EQUITY
(In thousands, except share data)
Accumulated other | ||||||||||||||||||||
comprehensive loss | ||||||||||||||||||||
Accumulated | ||||||||||||||||||||
Accumulated | unrealized | |||||||||||||||||||
foreign | gains (losses) on | |||||||||||||||||||
Additional | currency | available-for- | Total | |||||||||||||||||
Common | Common | paid in | translation | sale debt | Accumulated | stockholders’ | ||||||||||||||
stock | stock | capital | adjustments | securities | deficit | equity | ||||||||||||||
Balance as of 1 January 2019 |
| |
| |
| |
| ( |
| ( |
| ( |
| | ||||||
Net loss |
|
|
|
|
|
|
|
|
|
|
| ( |
| ( | ||||||
Issuance of shares upon exercise of stock options |
| |
| |
| |
| — |
| — |
| — |
| | ||||||
Other comprehensive loss | ||||||||||||||||||||
Foreign currency translation adjustments |
| — |
| — |
| — |
| ( |
| — |
| — |
| ( | ||||||
Unrealized holding gains on available-for-sale debt securities, net of tax of $- |
| — |
| — |
| — |
| — |
| |
| — |
| | ||||||
Share-based compensation expense |
| — |
| — |
| |
| — |
| — |
| — |
| | ||||||
Balance as of March 31, 2019 |
| | $ | | $ | | $ | ( | $ | | $ | ( | $ | | ||||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Issuance of shares upon exercise of stock options |
| |
| |
| |
| — |
| — |
| — |
| | ||||||
Other comprehensive income before reclassifications | ||||||||||||||||||||
Foreign currency translation adjustments |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
Unrealized holding gains on available-for-sale debt securities, net of tax of $- |
| — |
| — |
| — |
| — |
| |
| — |
| | ||||||
Reclassification from accumulated other comprehensive loss of gains on available-for-sale debt securities included in net income, net of tax of $- | — | — | — | — | ( | — | ( | |||||||||||||
Share-based compensation expense |
| — |
| — |
| |
| — |
| — |
| — |
| | ||||||
Balance as of June 30, 2019 |
| | $ | | $ | | $ | ( | $ | | $ | ( | $ | |
See accompanying notes to unaudited condensed consolidated financial statements.
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ADAPTIMMUNE THERAPEUTICS PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Six months ended |
| ||||||
June 30, | |||||||
| 2020 |
| 2019 |
| |||
Cash flows from operating activities | |||||||
Net loss | $ | ( | $ | ( | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation | | | |||||
Amortization | | | |||||
Share-based compensation expense | | | |||||
Unrealized foreign exchange (gains) losses | ( | | |||||
Other | | ( | |||||
Changes in operating assets and liabilities: | |||||||
Increase in receivables and other operating assets | ( | ( | |||||
Decrease in non-current operating assets | | | |||||
Increase (decrease) in payables and other current liabilities | | ( | |||||
Increase in deferred revenue | | | |||||
Net cash used in operating activities | ( | ( | |||||
Cash flows from investing activities | |||||||
Acquisition of property, plant and equipment | ( | ( | |||||
Acquisition of intangibles | ( | ( | |||||
Maturity or redemption of marketable securities | | | |||||
Investment in marketable securities | ( | ( | |||||
Net cash (used in) provided by investing activities | ( | | |||||
Cash flows from financing activities | |||||||
Proceeds from issuance of common stock, net of issuance costs | | — | |||||
Proceeds from exercise of stock options | | | |||||
Net cash provided by financing activities | | | |||||
Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | ( | | |||||
Net increase (decrease) in cash, cash equivalents and restricted cash | | ( | |||||
Cash, cash equivalents and restricted cash at start of period | | | |||||
Cash, cash equivalents and restricted cash at end of period | $ | | $ | | |||
See accompanying notes to unaudited condensed consolidated financial statements.
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ADAPTIMMUNE THERAPEUTICS PLC
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 proprietary SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables it to identify cancer targets, find and genetically engineer T-cell receptors (“TCRs”) against those targets, and produce therapeutic candidates (“SPEAR T-cells”) for administration to patients.
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 SPEAR T-cells, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s SPEAR T-cells, the need to develop a reliable commercial manufacturing process, the need to commercialize any T-cell therapies that may be approved for marketing, and protection of proprietary technology. If the Company does not successfully commercialize any of its SPEAR T-cells, it will be unable to generate product revenue or achieve profitability. The Company had an accumulated deficit of $
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 27, 2020 (the “Annual Report”). The balance sheet as of December 31, 2019 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.
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(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 the valuation of share options, valuation allowances relating to deferred tax assets, revenue recognition, estimation of the incremental borrowing rate for operating leases, estimating clinical trial expenses and estimating R&D tax and expenditure credits. 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
Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract
On January 1, 2020, the Company adopted ASU 2018-15 – Intangibles — Goodwill and Other — Internal-Use Software (Subtopic 350-40) Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The guidance aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal use software license). The Company elected to apply the guidance prospectively to all implementation costs incurred after the date of adoption. The guidance has not had a material effect on the condensed consolidated financial statements.
Simplifying the Accounting for Income Taxes
On January 1, 2020, the Company adopted ASU 2019-12 – Simplifying the Accounting for Income Taxes (Topic 740). The simplifications to accounting for income taxes cover a variety of areas, including the removal of the exception to the incremental approach for intraperiod tax allocation when there is a loss from continuing operations and income or a gain from other items (for example, discontinued operations or other comprehensive income). The changes also add a requirement for an entity to reflect the effect of an enacted change in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date. Most of the amendments should be applied on a prospective basis. The guidance has not had a material effect on the condensed consolidated financial statements.
12
Changes to the Disclosure Requirements for Fair Value Measurement
On January 1, 2020, the Company adopted ASU 2018-13 – Fair Value Measurement (Topic 820) - Disclosure Framework— Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement. Certain amendments apply prospectively with all other amendments applied retrospectively to all periods presented upon their effective date. The guidance has not had a material effect on the condensed consolidated financial statements.
Revenue Recognition in Collaborative Arrangements
On January 1, 2020, the Company adopted ASU 2018-18 – Collaborative Arrangements — Clarifying the Interaction between Topic 808 and Topic 606, which clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements. The guidance has been applied retrospectively to all contracts that were not completed at the date of initial application of Topic 606. The guidance has not had a material effect on the condensed consolidated financial statements because it did not change the Company’s accounting for existing or previous collaborative arrangements.
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 to the fiscal year beginning January 1, 2023. The Company currently intends to adopt the guidance in the fiscal year beginning January 1, 2023. 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.
Note 3 — Revenue
The Company has
Development revenue from contracts with customers in the three and six months ended June 30, 2020 comprises the following (in thousands):
Three months ended |
| Six months ended | ||||||||||
| June 30, | June 30, | ||||||||||
| 2020 |
| 2019 | 2020 |
| 2019 | ||||||
Development revenue |
| $ | |
| $ | | $ | |
| $ | | |
| $ | |
| $ | | $ | |
| $ | |
13
Deferred revenue increased by $
The Astellas Collaboration Agreement
On January 13, 2020, the Company entered into the Astellas Collaboration Agreement. The Company received $
Upon successful completion of the Phase 1 trial for a product, Astellas and Adaptimmune will elect whether to progress with co-development and co-commercialization of such product, or to allow the other party to pursue the candidate independently. If the parties progress with co-development and co-commercialization of a product, then each party will grant the other party a co-exclusive license to co-develop and co-commercialize such product in the field of T-cell therapy. If a product is developed solely by one party, then the other party will grant to the continuing party an exclusive license to develop and commercialize such product in the field of T-cell therapy.
In the three months ended June 30, 2020, the parties nominated the target for the first collaboration program and the Company has commenced development of this target under the agreement and has begun recognizing revenue for this performance obligation.
In addition, Astellas was also granted the right to develop, independently of Adaptimmune, allogeneic T-cell therapy candidates directed to
Under the terms of the agreement, Adaptimmune could be entitled to receive up to $
● | Development milestones of up to $ |
● | Development milestones of up to $ |
In addition, Adaptimmune is entitled to receive research funding of up to $
In consideration for rights under certain contributed Astellas technology for a product unilaterally developed by Adaptimmune, Astellas could be eligible to receive up to $
To the extent that Astellas and Adaptimmune co-develop and co-commercialize any product, the parties would share equally all worldwide costs and profits.
Either party can terminate the agreement in the event of material breach or insolvency of the other party. Astellas can terminate the Agreement for convenience in its entirety or partly in relation to any targets and products directed to such targets. Adaptimmune can terminate the Agreement for convenience in relation to any target it is unilaterally developing and to products directed to such target.
The Company has assessed the agreement under the provisions of ASC 606, Revenue from Contracts with Customers and ASC 808, Collaborative Arrangements. The Company determined that Astellas is a customer and has applied the provisions of ASC 606 to the contract and related performance obligations. The Company identified the following performance obligations under the agreement: (i) research services and rights granted under the co-exclusive for each of the
The aggregate transaction price at inception of the agreement was the $
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consideration and included in the transaction price as of June 30, 2020 to the extent that a significant reversal of revenue is not probable. The Company may also receive sales milestones upon the achievement of specified levels of annual net sales by Astellas under an independent Astellas program. These amounts have not been included within the transaction price as of June 30, 2020 because they are sales-based and would be recognized when the subsequent sales occur.
The aggregate transaction price is allocated to the performance obligations depending on the relative standalone selling price of the performance obligations. In determining the best estimate of the standalone selling price, the Company considered internal pricing objectives it used in negotiating the contract, together with internal data regarding the cost and margin of providing research services and adjusted-market data from comparable arrangements. The variable consideration is allocated to the performance obligation to which it relates.
The amount of the transaction price allocated to the performance obligation is recognized as or when the Company satisfies the performance obligation. The Company expects to satisfy the performance obligations relating to the three co-development targets as development progresses and recognizes revenue based on an estimate of the percentage of completion of the project determined based on the costs incurred on the project as a percentage of the total expected costs. The Company considers that this depicts the progress of the project, where the significant inputs would be internal project resources and third-party costs. The determination of the percentage of completion requires the Company to estimate the costs-to-complete the project. The Company makes a detailed estimate of the costs-to-complete, which is re-assessed every reporting period based on the latest project plan and discussions with project teams. If a change in facts or circumstances occurs, the estimate will be adjusted and the revenue will be recognized based on the revised estimate. The difference between the cumulative revenue recognized based on the previous estimate and the revenue recognized based on the revised estimate would be recognized as an adjustment to revenue in the period in which the change in estimate occurs. The revenue allocated to the research services will be recognized as development of products directed to the target progresses up until completion of a Phase 1 trial.
The Company has determined that the performance obligations relating to the
The amount of the transaction price that is allocated to performance obligations that are unsatisfied or partially satisfied under the agreement as of June 30, 2020 was $
Note 4 — Other (expense) income, net
Other (expense) income, net consisted of the following (in thousands):
Three months ended | Six months ended | |||||||||||
June 30, | June 30, | |||||||||||
| 2020 |
| 2019 |
| 2020 |
| 2019 | |||||
Foreign exchange (losses) gains |
| $ | ( |
| $ | ( |
| $ | |
| $ | ( |
Other |
| ( |
| |
|
| ( |
| | |||
| $ | ( |
| $ | ( | $ | |
| $ | ( |
Note 5 — Loss per share
The dilutive effect of
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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 June 30, 2020 are as follows (in thousands):
Fair value measurements using | ||||||||||||
June 30, | Level 1 | Level 2 | Level 3 | |||||||||
| 2020 |
|
|
| ||||||||
Assets: | ||||||||||||
Corporate debt securities |
| $ | |
| $ | |
| — |
| — | ||
Agency bonds | | | — | |||||||||
Treasury bills | | — | | — | ||||||||
| $ | |
| $ | |
| $ | |
| $ | — |
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.
Note 7 — Marketable securities
As of June 30, 2020, 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 | $ | | $ | | $ | — | $ | | ||||
Treasury bills | Less than 3 months | | | — | | |||||||||
Corporate debt securities | 3 months to 1 year | | | ( | | |||||||||
Agency bonds | 1 year to 2 years | | | — | | |||||||||
Corporate debt securities | 1 year to 2 years | | | ( | | |||||||||
|
| $ | | $ | | $ | ( | $ | |
As of June 30, 2020 and December 31, 2019, the aggregate fair value of securities held by the Company in an unrealized loss position was $
As of June 30, 2020, 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. 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.
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Note 8 — Other current assets
Other current assets consisted of the following (in thousands):
June 30, | December 31, | |||||
| 2020 |
| 2019 | |||
Corporate tax receivable |
| $ | |
| $ | |
Prepayments |
| |
| | ||
Clinical materials |
| |
| | ||
Other current assets |
| |
| | ||
$ | | $ | |
In July 2020, the Company received $
Note 9 — Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
June 30, | December 31, | |||||
| 2020 |
| 2019 | |||
Accrued clinical and development expenditures | $ | | $ | | ||
Accrued employee expenses | | | ||||
Other accrued expenditures | | | ||||
Accrued purchase commitments | | | ||||
Other |
| |
| | ||
$ | | $ | |
In 2016, the Company entered into a supply agreement with ThermoFisher for the supply of the Dynabeads® CD3/CD28 technology. The supply agreement runs until December 31, 2025. Under the supply agreement, the Company is required to purchase its requirements for CD3/CD28 magnetic bead product exclusively from ThermoFisher for a period of
Note 10 — 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 | Six months ended | |||||||||||||
June 30, | June 30, | |||||||||||||
| 2020 |
| 2019 |
| 2020 |
| 2019 | |||||||
Research and development | $ | | $ | | $ | | $ | |