Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 2021 and 2020
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 )
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Consolidated Financial Statements:
Consolidated Balance Sheets
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Consolidated Statements of Operations and Comprehensive Loss
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Consolidated Statements of Stockholders’ Equity
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Consolidated Statements of Cash Flows
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Notes to Consolidated Financial Statements
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Allogene Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Allogene Therapeutics, Inc. (the Company) as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, statements of stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2021 and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2021, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 23, 2022 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
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Accrued Clinical Trial Expenses
Description of the Matter
As discussed in Note 1 liabilities are recorded for estimated unpaid costs of research and development activities conducted by the Company and its third-party service providers, which include the conduct of preclinical and clinical studies, and contract manufacturing activities. Accrued research and development expenses were $13.5 million as of December 31, 2021 and includes the estimated costs of accrued clinical trial expenses incurred but not yet invoiced under agreements with investigative clinical trial sites that conduct research and development activities on behalf of the Company (“Accrued Clinical Trial Expenses”). The accrual for these Accrued Clinical Trial Expenses is determined after consideration of several factors, including estimates of the work completed. Auditing these Accrued Clinical Trial Expenses was complex due to the required analysis of extensive data in determining the estimated unpaid expenses.
How We Addressed the Matter in Our Audit
We obtained an understanding, evaluated the design, and tested the operating effectiveness of relevant controls over the Company’s determination of Accrued Clinical Trial Expenses, including controls over the determination of significant assumptions and the completeness and accuracy of the data used in determining these accrued costs.
Our audit procedures included, among others, testing the accuracy and completeness of the inputs used in management’s analysis to determine Accrued Clinical Trial Expenses. We verified that the accrued amounts were in accordance the terms and conditions of the underlying agreements and the information provided by third-party service providers. We also evaluated management’s estimates of the progress of the clinical trials by making direct inquiries of the Company’s personnel that oversee the clinical trials.
/s/ Ernst & Young LLP
We have served as the Company's auditor since 2018.
Redwood City, California
February 23, 2022
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ALLOGENE THERAPEUTICS, INC.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
December 31,
2021 December 31,
2020
Assets
Current assets:
Cash and cash equivalents $ 173,314 $ 183,351
Short-term investments 283,988 644,559
Prepaid expenses and other current assets 14,021 17,220
Total current assets 471,323 845,130
Long-term investments 352,179 204,208
Operating lease right-of-use asset 58,030 41,295
Property and equipment, net 122,990 118,840
Restricted cash 10,292 9,449
Other long-term assets 5,815 5,169
Equity method investment 18,005 3,738
Total assets $ 1,038,634 $ 1,227,829
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 10,255 $ 10,390
Accrued and other current liabilities 37,496 44,938
Deferred revenue 423 38,992
Total current liabilities 48,174 94,320
Lease liability, noncurrent 69,929 50,809
Other long-term liabilities 4,125 3,083
Total liabilities 122,228 148,212
Commitments and Contingencies (Notes 6, 7 and 8)
Stockholders’ equity:
Preferred stock, $ 0.001 par value: 10,000,000 authorized as of December 31, 2021 and December 31, 2020; no shares were issued and outstanding as of December 31, 2021 and December 31, 2020
— —
Common stock, $ 0.001 par value: 200,000,000 authorized as of December 31, 2021 and December 31, 2020; 142,623,065 and 140,474,305 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively
142 140
Additional paid-in capital 1,822,179 1,725,552
Accumulated deficit ( 903,348 ) ( 646,343 )
Accumulated other comprehensive (loss) income ( 2,567 ) 268
Total stockholders’ equity 916,406 1,079,617
Total liabilities and stockholders’ equity $ 1,038,634 $ 1,227,829
The accompanying notes are an integral part of these consolidated financial statements.
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ALLOGENE THERAPEUTICS, INC.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Year Ended December 31,
2021 2020 2019
Collaboration revenue - related party $ 38,489 $ — $ —
Operating expenses:
Research and development 220,176 192,987 144,535
General and administrative 74,105 65,256 57,473
Total operating expenses 294,281 258,243 202,008
Loss from operations ( 255,792 ) ( 258,243 ) ( 202,008 )
Other income (expense), net:
Interest and other income, net 1,714 9,164 17,351
Other expenses ( 2,927 ) ( 1,142 ) ( 268 )
Total other income (expense), net ( 1,213 ) 8,022 17,083
Loss before income taxes ( 257,005 ) ( 250,221 ) ( 184,925 )
Benefit from income taxes — — 331
Net loss ( 257,005 ) ( 250,221 ) ( 184,594 )
Other comprehensive income:
Net unrealized (loss) gain on available-for-sale investments, net of tax ( 2,835 ) ( 877 ) 839
Net comprehensive loss $ ( 259,840 ) $ ( 251,098 ) $ ( 183,755 )
Net loss per share, basic and diluted $ ( 1.89 ) $ ( 2.08 ) $ ( 1.83 )
Weighted-average number of shares used in computing net loss per
share, basic and diluted 135,820,386 120,370,177 101,061,149
The accompanying notes are an integral part of these consolidated financial statements.
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ALLOGENE THERAPEUTICS, INC.
Consolidated Statements of Stockholders’ Equity
(In thousands, except share and per share data)
Common Stock Additional
Paid-in
Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income (Loss) Total
Stockholders’
Equity
Shares Amount
Balance — December 31, 2018 121,482,671 $ 121 $ 914,265 $ ( 211,528 ) $ 306 $ 703,164
Issuance of common stock upon exercise of stock options and vesting of RSU's
711,623 1 2,958 — — 2,959
Vesting of early exercised common stock — — 4,590 — — 4,590
Stock-based compensation — — 46,063 — — 46,063
Employee stock purchase plan 107,982 — 1,783 — — 1,783
Issuance of common stock from ATM offering, net of commissions and offering costs of $ 1.6 million
1,965,082 2 54,217 — — 54,219
Net loss — — — ( 184,594 ) — ( 184,594 )
Net unrealized gain on available-for-sale investments — — — — 839 839
Balance — December 31, 2019 124,267,358 124 1,023,876 ( 396,122 ) 1,145 629,023
Issuance of common stock upon exercise of stock options and vesting of RSU's
1,725,695 2 8,813 — — 8,815
Vesting of early exercised common stock
— — 2,840 — — 2,840
Stock-based compensation
— — 65,261 — — 65,261
Employee stock purchase plan
175,142 — 2,843 — — 2,843
Issuance of common stock from ATM offering, net of commissions and offering costs of $ 0.6 million
848,663 1 26,202 — — 26,203
Issuance of common stock from public offering, net of commissions and offering costs of $ 36.8 million
13,457,447 13 595,717 — — 595,730
Net loss
— — — ( 250,221 ) — ( 250,221 )
Net unrealized loss on available-for-sale investments
— — — — ( 877 ) ( 877 )
Balance — December 31, 2020 140,474,305 140 1,725,552 ( 646,343 ) $ 268 1,079,617
Issuance of common stock upon exercise of stock options and vesting of RSU's
1,961,554 2 8,344 — — 8,346
Vesting of early exercised common stock
— — 3,848 — — 3,848
Stock-based compensation
— — 80,818 — — 80,818
Employee stock purchase plan
187,206 — 3,617 — — 3,617
Net loss
— — — ( 257,005 ) — ( 257,005 )
Net unrealized loss on available-for-sale investments
— — — — ( 2,835 ) ( 2,835 )
Balance — December 31, 2021 142,623,065 $ 142 $ 1,822,179 $ ( 903,348 ) $ ( 2,567 ) $ 916,406
The accompanying notes are an integral part of these consolidated financial statements.
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ALLOGENE THERAPEUTICS, INC.
Consolidated Statements of Cash Flows
(in thousands)
Year Ended December 31,
2021 2020 2019
Cash flows from operating activities:
Net loss $ ( 257,005 ) $ ( 250,221 ) $ ( 184,594 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation 80,818 65,261 46,063
Amortization of other intangible assets acquired — 151 603
Depreciation and amortization 10,454 7,435 4,424
Net amortization/accretion on investment securities 6,955 3,250 ( 3,596 )
Non-cash rent expense 2,611 3,955 6,777
Income tax benefit — — ( 331 )
Share of losses from equity method investments 3,444 1,154 182
Changes in operating assets and liabilities:
Prepaid expenses and other current assets 3,199 ( 3,177 ) ( 5,445 )
Other long-term assets ( 646 ) 34 ( 4,374 )
Accounts payable ( 767 ) 615 ( 985 )
Accrued and other current liabilities 3,652 18,726 6,351
Deferred revenue ( 38,569 ) 38,992 —
Other long-term liabilities 1,042 ( 1,268 ) ( 2,425 )
Net cash used in operating activities ( 184,812 ) ( 115,093 ) ( 137,350 )
Cash flows from investing activities:
Purchases of property and equipment ( 21,446 ) ( 65,958 ) ( 50,791 )
Purchase of stock in equity method investment ( 17,710 ) — ( 5,075 )
Proceeds from sales of investments — 4,799 —
Proceeds from maturities of investments 728,394 593,627 472,578
Purchase of investments ( 525,583 ) ( 1,037,591 ) ( 252,628 )
Net cash provided by (used in) investing activities 163,655 ( 505,123 ) 164,084
Cash flows from financing activities:
Proceeds from issuance of common stock from ATM offering, net of commissions and issuance costs — 26,203 54,219
Proceeds from issuance of common stock from public offering, net of commissions and issuance costs — 595,730 —
Proceeds from issuance of common stock and upon exercise of stock options 8,346 8,815 2,958
Proceeds from issuance of common stock under the employee stock purchase plan 3,617 2,843 1,783
Net cash provided by financing activities 11,963 633,591 58,960
Net increase (decrease) in cash, cash equivalents and restricted cash ( 9,194 ) 13,375 85,694
Cash, cash equivalents and restricted cash — beginning of period 192,800 179,425 93,731
Cash, cash equivalents and restricted cash — end of period $ 183,606 $ 192,800 $ 179,425
Non-cash operating, investing and financing activities:
Right-of-use asset obtained in exchange for lease liability $ 20,079 $ — $ 13,827
Property and equipment purchases in accounts payable and accrued and other current liabilities $ 1,725 $ 8,567 $ 4,668
Capitalized cloud computing costs included in accounts payable and accrued and other current liabilities $ — $ 584 $ —
Deferred offering costs included in accounts payable and accrued and other current liabilities $ — $ — $ 135
Supplemental disclosure:
Cash paid for amounts included in the measurement of lease liabilities $ ( 6,013 ) $ ( 6,244 ) $ ( 3,563 )
Cash received for amounts related to tenant improvement allowances from lessors $ 1,111 $ 2,809 $ 4,473
The accompanying notes are an integral part of these consolidated financial statements.
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ALLOGENE THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
Note 1. Description of Business and Summary of Significant Accounting Policies
Allogene Therapeutics, Inc. (the Company or Allogene) was incorporated on November 30, 2017 in the State of Delaware and is headquartered in South San Francisco, California. Allogene is a clinical-stage immuno-oncology company pioneering the development of genetically engineered allogeneic T cell therapies for the treatment of cancer. The Company is developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells.
Public Offerings
In November 2019, the Company entered into a sales agreement with Cowen and Company, LLC (Cowen), under which the Company may from time to time issue and sell shares of its common stock through Cowen in at-the-market (ATM) offerings for an aggregate offering price of up to $ 250.0 million. The aggregate compensation payable to Cowen as the Company's sales agent equals up to 3.0 % of the gross sales price of the shares sold through it pursuant to the sales agreement. During the year ended December 31, 2020, we sold an aggregate of 848,663 shares of common stock in ATM offerings resulting in net proceeds of $ 26.2 million.
In June 2020, the Company sold 13,457,447 shares of its common stock, which included 1,755,319 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares, in an underwritten public offering at a price of $ 47.00 per share, which resulted in gross proceeds of approximately $ 632.5 million. Net proceeds to the Company after deducting the underwriting discounts and commissions and other expenses were approximately $ 595.7 million.
Need for Additional Capital
The Company has sustained operating losses and expects to continue to generate operating losses for the foreseeable future. The Company’s ultimate success depends on the outcome of its research and development activities as well as the ability to commercialize the Company’s product candidates. The Company had cash, cash equivalents and investments of $ 809.5 million as of December 31, 2021. Since inception through December 31, 2021, the Company has incurred cumulative net losses of $ 903.3 million. Management expects to incur additional losses in the future to fund its operations and conduct product research and development and recognizes the need to raise additional capital to fully implement its business plan.
The Company intends to raise additional capital through the issuance of equity securities, debt financings or other sources in order to further implement its business plan. However, if such financing is not available at adequate levels, the Company will need to reevaluate its operating plan and may be required to delay the development of its product candidates. The Company expects that its cash and cash equivalents and investments will be sufficient to fund its operations for at least the next 12 months from the date the Company’s Annual Report on Form 10-K is filed with the Securities and Exchange Commission (SEC).
The Company cannot at this time predict the specific extent, duration, or full impact that the ongoing COVID-19 pandemic will have on its financial condition and operations, including ongoing and planned clinical trials. The impact of the COVID-19 pandemic on the financial performance of the Company will depend on future developments, including the duration and spread of the pandemic and related governmental advisories and restrictions. These developments and the impact of the COVID-19 pandemic on the financial markets and the overall economy are highly uncertain. If business conditions, financial markets and/or the overall economy are impacted for an extended period, the Company’s results may be adversely affected.
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP).
In June 2020, the Company formed a wholly-owned, Netherlands-based subsidiary, Allogene Therapeutics, B.V., to help prepare for and assist with the Company's activities in Europe. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All material intercompany balances and transactions have been eliminated during consolidation.
Use of Estimates
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The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include but are not limited to the fair value of common stock, the fair value of stock options, the fair value of investments, income tax uncertainties, and certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances change. Actual results could differ from those estimates.
Concentration of Credit and other Risks and Uncertainties
Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents and investments. The primary objectives for the Company’s investment portfolio are the preservation of capital and the maintenance of liquidity. The Company does not enter into any investment transaction for trading or speculative purposes.
The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, commercial paper, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. The Company maintains cash balances in excess of amounts insured by the FDIC and concentrated within a limited number of financial institutions. The accounts are monitored by management and management believes that the financial institutions are financially sound, and, accordingly, minimal credit risk exists with respect to these financial institutions. As of December 31, 2021 and 2020, the Company has not experienced any credit losses in such accounts or investments.
The Company is subject to a number of risks common for early-stage biopharmaceutical companies including, but not limited to, dependency on the clinical and commercial success of its product candidates, ability to obtain regulatory approval of its product candidates, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and patients, significant competition and untested manufacturing capabilities.
Segments
Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (CODM) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in a single operating segment and has one reportable segment.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in bank money market accounts and money market mutual funds.
The Company has issued letters of credit under separate lease and other agreements which have been collateralized by restricted cash. This cash is classified as long-term restricted cash on the accompanying consolidated balance sheets based on the terms of the underlying agreements.
Investments
Investments are available-for-sale and are carried at estimated fair value. The Company’s valuations of marketable securities are generally derived from independent pricing services based upon quoted prices in active markets for similar securities, with prices adjusted for yield and number of days to maturity, or based on industry models using data inputs, such as interest rates and prices that can be directly observed or corroborated in active markets. Management determines the appropriate classification of its investments in debt securities at the time of purchase and at the end of each reporting period. Investments with original maturities of less than three months at the date of purchase are classified as cash and cash equivalents. Investments with original maturities beyond three months at the date of purchase and which mature at, or less than twelve months from the consolidated balance sheet date are classified as current.
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Unrealized gains and losses are excluded from earnings and are reported as a component of other comprehensive income. The Company periodically evaluates whether declines in fair values of its available-for-sale securities below their book value are other-than-temporary. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale securities before recovery of its amortized cost basis. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income, net. The cost of investments sold is based on the specific-identification method. Interest income on investments is included in interest and other income, net.
Fair Value Measurement
Assets and liabilities recorded at fair value on a recurring basis in the consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3— Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Property and Equipment, Net
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed on a straight-line basis over the estimated useful lives of the related assets, generally three to seven years . Maintenance and repairs are charged to operations as incurred. Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the consolidated balance sheet and the resulting gain or loss is reflected in other expense.
The Company has determined the estimated life of assets to be as follows:
Laboratory equipment 5 years
Computer equipment and purchased software 3 - 5 years
Fixtures and furniture 7 years
Leasehold improvements Shorter of lease term or useful life
The Company adopted Accounting Standards Update ("ASU") No. 2018-15, Intangibles – Goodwill and other – Internal-Use Software (Subtopic 350-40) on January 1, 2020 on a prospective basis. The Company capitalizes implementation costs associated with internal use cloud computing arrangements in alignment with ASC 350-40 internal-use software. Costs incurred in preliminary project stage and post implementation stage are expensed as incurred. Costs incurred during the application development stage of implementation are capitalized in other long term assets on the consolidated balance sheet. Capitalized implementation costs from cloud computing arrangements are amortized over the term of the cloud-based service arrangement.
Leases
The Company early adopted ASU No. 2016-2, Leases on January 1, 2018. For its long-term operating leases, the Company recognizes a right-of-use asset and a lease liability on its consolidated balance sheets. The lease liability is determined as the present value of future lease payments using an estimated rate of interest that the Company would pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The right-of-use asset is based on the liability
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adjusted for any prepaid or deferred rent. The lease term at the commencement date is determined by considering whether renewal options and termination options are reasonably assured of exercise.
Rent expense for the operating lease is recognized on a straight-line basis over the lease term and is included in operating expenses on the consolidated statements of operations and comprehensive loss. Variable lease payments include lease operating expenses.
The Company elected to exclude from its consolidated balance sheets recognition of leases having a term of 12 months or less (short-term leases) and elected to not separate lease components and non-lease components for its long-term real-estate leases.
Equity Method Investments
The Company uses the equity method of accounting for equity investments in companies if the investment provides the ability to exercise significant influence, but not control, over operating and financial policies of the investee. The Company's proportionate share of the net income or loss of these companies is included in other expenses in the consolidated statement of operations. Judgment regarding the level of influence over each equity method investment includes considering key factors such as our ownership interest, representation on the board of directors, participation in policy-making decisions and material purchase and sale transactions.
The Company evaluates equity method investments for impairment whenever events or changes in circumstances indicate that the carrying amount of the investment might not be recoverable. Factors considered when reviewing an equity method investment for impairment include the length of time (duration) and the extent (severity) to which the fair value of the equity method investment has been less than cost, the investee’s financial condition and near-term prospects and the intent and ability to hold the investment for a period of time sufficient to allow for anticipated recovery. An impairment that is other-than-temporary is recognized in the period identified.
Variable Interest Entities
For entities in which the Company has variable interests, the Company focuses on identifying if one of the entities is the primary beneficiary through having the power to direct the activities that most significantly impact the variable interest entity’s economic performance and having the obligation to absorb losses or the right to receive benefits from the variable interest entity. If the Company is the primary beneficiary of a variable interest entity, the assets, liabilities, and results of operations of the variable interest entity will be included in the Company’s consolidated financial statements. The Company did not consolidate any variable interest entities in any of the periods presented because the Company determined that it was not the primary beneficiary.
Accrued Research and Development Costs
The Company records accrued liabilities for estimated costs of research and development activities conducted by collaboration partners and third-party service providers, which include the conduct of preclinical studies and clinical trials, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued and other current liabilities on the consolidated balance sheets and within research and development expenses on the consolidated statements of operations and comprehensive loss.
The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its collaboration partners and third-party service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance at the end of each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception.
Income Taxes
Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is
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more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and net losses, the net deferred tax assets have been fully offset by a valuation allowance.
The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Changes in recognition or measurement are reflected in the period in which judgment occurs. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of the provision for income taxes.
Stock-Based Compensation
The Company measures its stock-based awards granted to employees, consultants and directors based on the estimated fair values of the awards and recognizes the compensation over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of its stock-based awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive. Shares of common stock subject to repurchase are excluded from the weighted-average shares.
Comprehensive Loss
Comprehensive loss includes net loss and certain changes in stockholders’ equity that are excluded from net loss. For the years ended December 31, 2021, 2020 and 2019 this was comprised of unrealized gains and losses, net of tax, on the Company’s investments.
Impairment of Long-Lived Assets
Long-lived assets are reviewed annually for impairment or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amount of an asset group to the future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. There were impairment losses related to equipment disposals of less than $ 0.1 million and $ 0.2 million for the years ended December 31, 2021 and 2019, respectively. There were no impairment losses related to equipment disposals for the year ended December 31, 2020.
Revenue Recognition
The Company’s revenue has been generated through collaboration research and license agreements. The terms of these agreements may contain multiple deliverables which may include (i) grant of licenses, (ii) transfer of know-how, (iii) research and development activities, (iii) clinical manufacturing and, (iv) product supply. The payment terms of these agreements may include nonrefundable upfront fees, payments for research and development activities, payments based upon the achievement of certain milestones, royalty payments based on product sales derived from the collaboration, and payments for supplying product.
The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (ASC 808) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606, Revenue
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from Contracts with Customers (ASC 606). For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to Topic 606.
For elements of those arrangements that the Company determines should be accounted for under ASC 606, the Company assesses which activities in the collaboration agreements are performance obligations that should be accounted for separately and determine the transaction price of the arrangement, which includes the assessment of the probability of achievement of future milestones and other potential consideration. A performance obligation represents a promise in a contract to transfer a distinct good or service to a customer, which represents a unit of accounting in accordance with ASC 606. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. The Company considers a performance obligation satisfied once the Company has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. A portion of the consideration should be allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. The total consideration which the Company expects to collect in exchange for the Company’s products is an estimate and may be fixed or variable. The Company constrains the estimated variable consideration when it assesses it is probable that a significant reversal in the amount of cumulative revenue recognized may occur in future periods. The transaction price is re-evaluated, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The allocation of the transaction price is performed based on standalone selling prices, which are based on estimated amounts that the Company would charge for a performance obligation if it were sold separately. Revenue is recognized when, or as, performance obligations in the contracts are satisfied, in the amount reflecting the expected consideration to be received from the goods or services transferred to the customers. Funds received in advance are recorded as deferred revenue and are recognized as the related performance obligation is satisfied.
Research and Development Expenses
Research and development costs are expensed as incurred and consist of salaries and benefits, including associated stock-based compensation, and laboratory supplies and facility costs, as well as fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Research and development expenses also include costs incurred for internal and sponsored collaborative research and development activities. Costs associated with co-development activities performed under the various license and collaboration agreements are included in research and development expenses.
Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized and then expensed as the related goods are delivered or the services are performed.
Note 2. Recent Accounting Guidance
Recently Adopted Accounting Pronouncements
In January 2020, the FASB issued Accounting Standard Update No. 2020-01, Investments – Equity Securities (Topic 321), Investments – Equity Method and Joint Ventures (Topic 323), which clarifies the interactions between Topics 321 and 323 in applying or discontinuing the equity method of accounting for investments. This guidance is effective for fiscal years beginning after December 15, 2020, with early adoption permitted. The Company adopted this standard on January 1, 2021 on a prospective basis. Adoption of the new guidance had no significant impact on the Company's consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted
The Company continues to monitor new accounting pronouncements issued by the FASB and does not believe any accounting pronouncements issued through the date of this report will have a material impact on the Company's consolidated financial statements.
Note 3. Fair Value Measurements
The Company follows authoritative accounting guidance, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.
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The Company measures and reports its cash equivalents, restricted cash, and investments at fair value.
Money market funds are measured at fair value on a recurring basis using quoted prices and are classified as Level 1. Investments are measured at fair value based on inputs other than quoted prices that are derived from observable market data and are classified as Level 2 inputs, except for investments in U.S. treasury securities which are classified as Level 1.
There were no Level 3 assets or liabilities at December 31, 2021 or 2020.
Financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type as of December 31, 2021 are presented in the following table:
December 31, 2021
Level 1 Level 2 Level 3 Fair Value
(in thousands)
Financial Assets:
Money market funds ¹ $ 115,867 $ — $ — $ 115,867
Commercial paper — 58,976 — 58,976
Corporate bonds — 223,474 — 223,474
U.S. treasury securities 303,016 — — 303,016
U.S. agency securities — 50,701 — 50,701
Total financial assets $ 418,883 $ 333,151 $ — $ 752,034
¹ Included within cash and cash equivalents on the Company’s consolidated balance sheet
Financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type as of December 31, 2020 are presented in the following table:
December 31, 2020
Level 1 Level 2 Level 3 Fair Value
(in thousands)
Financial Assets:
Money market funds ¹ $ 102,039 $ — $ — $ 102,039
Commercial paper — 58,975 — 58,975
Corporate bonds — 262,757 — 262,757
U.S. treasury securities 446,996 — — 446,996
U.S. agency securities — 80,039 — 80,039
Total financial assets $ 549,035 $ 401,771 $ — $ 950,806
¹ Included within cash and cash equivalents on the Company’s consolidated balance sheet
The carrying amounts of accounts payable and accrued liabilities approximate their fair values due to their short-term maturities. The Company’s Level 2 securities are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly.
There were no transfers of assets between the fair value measurement levels during the years ended December 31, 2021 or 2020.
Note 4. Investments
The fair value and amortized cost of cash equivalents and available-for-sale securities by major security type as of December 31, 2021 are presented in the following table:
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December 31, 2021
Amortized Cost Unrealized Gains Unrealized Losses Fair Value
(in thousands)
Money market funds $ 115,867 $ — $ — $ 115,867
Commercial paper 58,981 2 ( 7 ) 58,976
Corporate bonds 224,092 29 ( 647 ) 223,474
U.S. treasury securities 304,142 2 ( 1,128 ) 303,016
U.S. agency securities 51,075 — ( 374 ) 50,701
Total cash equivalents and investments $ 754,157 $ 33 $ ( 2,156 ) $ 752,034
Classified as:
Cash equivalents $ 115,867
Short-term investments 283,988
Long-term investments 352,179
Total cash equivalents, and investments $ 752,034
The fair value and amortized cost of cash equivalents and available-for-sale securities by major security type as of December 31, 2020 are presented in the following table:
December 31, 2020
Amortized Cost Unrealized Gains Unrealized Losses Fair Value
(in thousands)
Money market funds $ 102,039 $ — $ — $ 102,039
Commercial paper 58,969 8 ( 2 ) 58,975
Corporate bonds 262,349 444 ( 36 ) 262,757
U.S. treasury securities 446,726 282 ( 12 ) 446,996
U.S. agency securities 80,012 30 ( 3 ) 80,039
Total cash equivalents and investments $ 950,095 $ 764 $ ( 53 ) $ 950,806
Classified as:
Cash equivalents $ 102,039
Short-term investments 644,559
Long-term investments 204,208
Total cash equivalents, and investments $ 950,806
The Company believes that it is more likely than not that investments in an unrealized loss position will be held until maturity and all interest and principal will be received. The Company does not intend to sell these investments and it is more likely than not that the Company will not be required to sell the investment before recovery of its amortized cost basis.
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The fair values of available-for-sale debt investments by contractual maturity as of December 31, 2021 and 2020 were as follows:
December 31,
2021 2020
(in thousands)
Due in 1 year or less $ 283,988 $ 644,559
Due in 1 - 2 years 314,130 148,211
Due in 3 years 38,049 55,997
Instruments not due at a single maturity date 115,867 102,039
Total cash equivalents and investments $ 752,034 $ 950,806
As of December 31, 2021 and 2020, the remaining contractual maturities of available-for-sale securities were less than three years . There have been no significant realized losses on available-for-sale securities for the years ended December 31, 2021, 2020 and 2019. As of December 31, 2021 and 2020, unrealized losses on available-for-sale securities are not attributed to credit risk. The Company believes that it is more likely than not that investments in an unrealized loss position will be held until maturity and all interest and principal will be received. The Company believes that an allowance for credit losses is unnecessary because the unrealized losses on certain of the Company’s available-for-sale securities are due to market factors. As of December 31, 2021 and 2020, securities with a fair value of zero and $ 5.0 million, respectively, were in a continuous net unrealized loss position for more than 12 months. To date, the Company has not recorded any impairment charges on available-for-sale securities.
As of December 31, 2021 and 2020, the Company recognized $ 1.9 million and $ 2.8 million of accrued interest receivable from available-for-sale securities within prepaid expenses and other current assets on the consolidated balance sheets.
Note 5. Balance Sheet Components
Property and Equipment, Net
December 31,
2021 2020
(in thousands)
Leasehold improvements $ 108,353 $ 31,518
Laboratory equipment 29,666 23,810
Computers equipment and purchased software 4,373 4,088
Furniture and fixtures 3,920 3,388
Construction in progress 39 68,944
Total 146,351 131,748
Less: accumulated depreciation ( 23,361 ) ( 12,908 )
Total property and equipment, net $ 122,990 $ 118,840
Depreciation expense for the years ended December 31, 2021, 2020 and 2019 was $ 10.5 million, $ 7.4 million and $ 4.6 million respectively. Disposals of property and equipment were less than $ 0.1 million, zero and $ 0.2 million for the years ended December 31, 2021, 2020 and 2019, respectively.
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Accrued Liabilities
Accrued liabilities consist of the following:
December 31,
2021 2020
(in thousands)
Accrued compensation and related benefits $ 16,126 $ 15,943
Accrued research and development expenses 13,521 13,887
Accrued property and equipment — 7,475
Unvested shares liability 2,904 2,842
Other 4,945 4,791
Total accrued and other current liabilities $ 37,496 $ 44,938
Note 6. License and Collaboration Agreements
Asset Contribution Agreement with Pfizer
In April 2018, the Company entered into an Asset Contribution Agreement (the Pfizer Agreement) with Pfizer pursuant to which the Company acquired certain assets, including certain contracts and intellectual property for the development and administration of chimeric antigen receptor (CAR) T cells for the treatment of cancer. The Company is required to make milestone payments upon successful completion of regulatory and sales milestones on a target-by-target basis for the targets including CD19 and B-cell maturation antigen (BCMA), covered by the Pfizer Agreement. The aggregate potential milestone payments upon successful completion of various regulatory milestones in the United States and the European Union are $ 30.0 million or $ 60.0 million, depending on the target, with aggregate potential regulatory and development milestones of up to $ 840.0 million, provided that the Company is not obligated to pay a milestone for regulatory approval in the European Union for an anti-CD19 allogeneic CAR T cell product, to the extent Servier has commercial rights to such territory. The aggregate potential milestone payments upon reaching certain annual net sales thresholds in North America, Europe, Asia, Australia and Oceania (the Territory) for a certain number of targets covered by the Pfizer Agreement are $ 325.0 million per target. The sales milestones in the foregoing sentence are payable on a country-by-country basis until the last to expire of any Pfizer Royalty Term, as described below, for any product in such country in the Territory. In October 2019, the Territory was expanded to all countries in the world. No milestone or royalty payments were made in the years ended December 31, 2021, 2020 and 2019.
Pfizer is also eligible to receive, on a product-by-product and country-by-country basis, royalties in single-digit percentages on annual net sales for products covered by the Pfizer Agreement or that use certain Pfizer intellectual property and for which an IND is first filed on or before April 6, 2023. The Company’s royalty obligation with respect to a given product in a given country begins upon the first sale of such product in such country and ends on the later of (i) expiration of the last claim of any applicable patent or (ii) 12 years from the first sale of such product in such country.
Research Collaboration and License Agreement with Cellectis
As part of the Pfizer Agreement, Pfizer assigned to the Company a Research Collaboration and License Agreement (the Original Cellectis Agreement) with Cellectis S.A. (Cellectis). On March 8, 2019, the Company entered into a License Agreement (the Cellectis Agreement) with Cellectis. In connection with the execution of the Cellectis Agreement, on March 8, 2019, the Company and Cellectis also entered into a letter agreement (the Letter Agreement), pursuant to which the Company and Cellectis agreed to terminate the Original Cellectis Agreement. The Original Cellectis Agreement included a research collaboration to conduct discovery and pre-clinical development activities to generate CAR T cells directed at targets selected by each party, which was completed in June 2018.
Pursuant to the Cellectis Agreement, Cellectis granted to the Company an exclusive, worldwide, royalty-bearing license, on a target-by-target basis, with sublicensing rights under certain conditions, under certain of Cellectis’s intellectual property, including its TALEN and electroporation technology, to make, use, sell, import, and otherwise exploit and commercialize CAR T products directed at certain targets, including BCMA, FLT3, DLL3 and CD70 (the Allogene Targets), for human oncologic therapeutic, diagnostic, prophylactic and prognostic purposes. In addition, certain Cellectis intellectual property rights granted by Cellectis to the Company and to Servier pursuant to the Exclusive License and Collaboration
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Agreement by and between Servier and Pfizer, dated October 30, 2016, which Pfizer assigned to the Company in April 2018, will survive the termination of the Original Cellectis Agreement.
Pursuant to the Cellectis Agreement, the Company granted Cellectis a non-exclusive, worldwide, royalty-free, perpetual and irrevocable license, with sublicensing rights under certain conditions, under certain of the Company's intellectual property, to make, use, sell, import and otherwise commercialize CAR T products directed at certain targets (the Cellectis Targets).
The Cellectis Agreement provides for development and sales milestone payments by the Company of up to $ 185.0 million per product that is directed against an Allogene Target, with aggregate potential development and sales milestone payments totaling up to $ 2.8 billion. Cellectis is also eligible to receive tiered royalties on annual worldwide net sales of any products that are commercialized by the Company that contain or incorporate, are made using or are claimed or covered by, Cellectis intellectual property licensed to the Company under the Cellectis Agreement (the Allogene Products), at rates in the high single-digit percentages. Such royalties may be reduced, on a licensed product-by-licensed product and country-by-country basis, for generic entry and for payments due under licenses of third party patents. Pursuant to the Cellectis Agreement, and subject to certain exceptions, the Company is required to indemnify Cellectis against all third party claims related to the development, manufacturing, commercialization or use of any Allogene Product or arising out of the Company’s material breach of the representations, warranties or covenants set forth in the Cellectis Agreement, and Cellectis is required, subject to certain exceptions, to indemnify the Company against all third party claims related to the development, manufacturing, commercialization or use of CAR T products directed at Cellectis Targets or arising out of Cellectis’s material breach of the representations, warranties or covenants set forth in the Cellectis Agreement.
The royalties are payable, on a licensed product-by-licensed product and country-by-country basis, until the later of (i) the expiration of the last to expire of the licensed patents covering such product; (ii) the loss of regulatory exclusivity afforded such product in such country, and (iii) the tenth anniversary of the date of the first commercial sale of such product in such country; however, in no event shall such royalties be payable, with respect to a particular licensed product, past the twentieth anniversary of the first commercial sale for such product.
Depending on the Cellectis Target, the Company has a right of first refusal or right of first negotiation to purchase or license from Cellectis rights to develop and commercialize products against such Cellectis Targets.
Under the Cellectis Agreement, the Company has certain diligence obligations to progress the development of CAR T product candidates and to commercialize one CAR T product per Allogene Target in one major market country where the Company has received regulatory approval. If the Company materially breaches any of its diligence obligations and fails to cure within 90 days, then with respect to certain targets, such target will cease to be an Allogene Target and instead will become a Cellectis Target.
Unless earlier terminated in accordance with its terms, the Cellectis Agreement will expire on a product-by-product and country-by-country basis, upon expiration of all royalty payment obligations with respect to such licensed product in such country. The Company has the right to terminate the Cellectis Agreement at will upon 60 days’ prior written notice, either in its entirety or on a target-by-target basis. Either party may terminate the Cellectis Agreement, in its entirety or on a target-by-target basis, upon 90 days’ prior written notice in the event of the other party’s uncured material breach. The Cellectis Agreement may also be terminated by the Company upon written notice at any time in the event that Cellectis becomes bankrupt or insolvent or upon written notice within 60 days of a consummation of a change of control of Cellectis.
All costs the Company incurred in connection with this agreement were recognized as research and development expenses in the consolidated statement of operations. For the years ended December 31, 2021 and 2019, $ 10 million and $ 5 million, respectively, of costs were incurred related to the achievement of clinical development milestones under this agreement. Zero clinical development milestones were achieved for the year ended December 31, 2020.
License and Collaboration Agreement with Servier
As part of the Pfizer Agreement, Pfizer assigned to the Company an Exclusive License and Collaboration Agreement (the Servier Agreement), with Les Laboratoires Servier SAS and Institut de Recherches Internationales Servier SAS (collectively, Servier) to develop, manufacture and commercialize certain allogeneic anti-CD19 CAR T cell product candidates, including UCART19, in the United States with the option to obtain the rights over additional anti-CD19 product candidates and for allogeneic CAR T cell product candidates directed against one additional target. In October 2019, the Company agreed to waive its rights to the one additional target.
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Under the Servier Agreement, the Company has an exclusive license to develop, manufacture and commercialize UCART19 in the field of anti-tumor adoptive immunotherapy in the United States, with an exclusive option to obtain the same rights for additional product candidates in the United States and, if Servier does not elect to pursue development or commercialization of those product candidates in certain markets outside of the United States pursuant to its license, outside of the United States as well. The Company is not required to make any additional payments to Servier to exercise an option. If the Company opts-in to another product candidate, Servier has the right to obtain rights to such product candidate outside the United States and to share development costs for such product candidate.
Under the Servier Agreement, the Company is required to use commercially reasonable efforts to develop and obtain marketing approval in the United States in the field of anti-tumor adoptive immunotherapy for at least one product directed against CD19, and Servier is required to use commercially reasonable efforts to develop and obtain marketing approval in the European Union, and one other country in a group of specified countries outside of the European Union and the United States, in the field of anti-tumor adoptive immunotherapy for at least one allogeneic adaptive T cell product directed against a certain Company-selected target.
For product candidates that the Company is co-developing with Servier, including UCART19, ALLO-501 and ALLO-501A, the Company is responsible for 60 % of the specified development costs and Servier is responsible for the remaining 40 % of the specified development costs under the applicable global research and development plan. Subject to certain restrictions, each party has the right to conduct activities that are specific to its territory outside the global research and development plan at such party’s sole expense. In addition, each party is solely responsible for commercialization activities in its territory at such party’s sole expense.
The Company is required to make milestone payments to Servier upon successful completion of regulatory and sales milestones. The Servier Agreement provides for aggregate potential payments by the Company to Servier of up to $ 137.5 million upon successful completion of various regulatory milestones, and aggregate potential payments by the Company to Servier of up to $ 78.0 million upon successful completion of various sales milestones. Similarly, Servier is required to make milestone payments upon successful completion of regulatory and sales milestones for products directed at the Allogene-target covered by the Servier Agreement that achieves such milestones. The total potential payments that Servier is obligated to make to the Company under the Servier Agreement upon successful completion of regulatory and sales milestones are $ 42 million and € 70.5 million ($ 79.8 million), respectively. The foregoing milestones are subject to certain adjustments if the Company obtains rights for certain products outside of the United States upon Servier’s election not to pursue such rights.
Each party is also eligible to receive tiered royalties on annual net sales in countries within the paying party’s respective territory of any licensed products that are commercialized by such party that are directed at the targets licensed by such party under the Servier Agreement. The royalty rates are in a range from the low tens to the high teen percentages. Such royalties may be reduced for interchangeable drug entry, expiration of patent rights and amounts paid pursuant to licenses of third-party patents. The royalty obligation for each party with respect to a given licensed product in a given country in each party’s respective territory (the Servier Royalty Term) begins upon the first commercial sale of such product in such country and ends after a defined number of years.
Unless earlier terminated in accordance with the Servier Agreement, the Servier Agreement will continue, on a licensed product-by-licensed product and country-by-country basis, until the Servier Royalty Term with respect to the sale of such licensed product in such country expires.
For the years ended December 31, 2021 and 2020, the Company recorded $ 17.1 million and $ 8.5 million, respectively, of net cost recoveries under the cost-sharing terms as a reduction to research and development expenses. For the year ended December 31, 2019, the Company recorded $ 7.3 million of costs incurred under the collaboration agreement with Servier as research and development expenses. As of December 31, 2021 and 2020, amounts due from Servier of $ 4.1 million and $ 3.8 million, respectively, were recorded in other current assets in the accompanying consolidated balance sheets.
Research Collaboration and License Agreement with Notch Therapeutics
On November 1, 2019, the Company entered into a Collaboration and License Agreement (the Notch Agreement) with Notch Therapeutics Inc. (Notch), pursuant to which Notch granted to Allogene an exclusive, worldwide, royalty-bearing, sublicensable license under certain of Notch’s intellectual property to develop, make, use, sell, import, and otherwise commercialize therapeutic gene-edited T cell and/or natural killer (NK) cell products from induced pluripotent stem cells directed at certain CAR targets for initial application in non-Hodgkin lymphoma, acute lymphoblastic leukemia and multiple myeloma. In addition, Notch has granted Allogene an option to add certain specified targets to its exclusive license in exchange for an agreed per-target option fee.
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The Notch Agreement includes a research collaboration to conduct research and pre-clinical development activities to generate engineered cells directed to Allogene’s exclusive targets, which will be conducted in accordance with an agreed research plan and budget under the oversight of a joint development committee. Allogene will reimburse Notch’s costs incurred in accordance with such plan and budget. The term of the research collaboration will expire upon the earlier of (i) the fifth anniversary of the date of the Notch Agreement, (ii) at Allogene’s election, following the joint development committee’s determination that for each exclusive target, Notch has met certain success criteria, or (iii) the joint development committee’s determination that the research collaboration cannot be reasonably pursued against any exclusive target due to technical infeasibility or safety issues.
In connection with the execution of the Notch Agreement, Allogene made an upfront payment to Notch of $ 10.0 million in return for a license to access Notch's technology in order to conduct research pursuant to the Notch Agreement. The Company recognized a research and development expense of $ 10 million during the year ended December 31, 2020 as the license had no foreseeable alternative future use. In addition, Allogene made a $ 5.0 million investment in Notch’s series seed convertible preferred stock, resulting in Allogene having a 25 % ownership interest in Notch’s outstanding capital stock on a fully diluted basis immediately following the investment. In connection with this investment, an Allogene representative serves on the Notch Board of Directors. In February 2021, the Company made an additional $ 15.9 million investment in Notch's Series A preferred stock. In October 2021, the Company made an additional $ 1.8 million investment in Notch's common stock. Immediately following this transaction, the Company's share in Notch was 23.0 % on a voting interest basis. The Company did not have a controlling interest in Notch as of December 31, 2021, and continued to account for its investment in Notch as an equity method investment.
Under the Notch Agreement, Notch will be eligible to receive up to $ 7.25 million upon achieving certain agreed research milestones, up to $ 4.0 million per exclusive target upon achieving certain pre-clinical development milestones, and up to $ 283.0 million per exclusive target and cell type (i.e., T cell or NK cell) upon achieving certain clinical, regulatory and commercial milestones. Notch is also entitled to receive tiered royalties in the mid to high single digit range on Allogene’s sales of licensed products, subject to certain reductions, for a term, on a country-by-country and product-by-product basis, commencing on first commercial sale of such product in such country and continuing until the latest of (i) the date upon which there is no valid claim of the licensed patents in such country of sale that covers such product, (ii) the expiration of applicable data or other regulatory exclusivity in such country of sale or (iii) a defined period from the first commercial sale of such product in such country.
The terms of the Notch Agreement will continue on a product-by-product and country-by-country basis until Allogene’s payment obligations with respect to such product in such country have expired. Following such expiration, Allogene’s license with respect to such product and country shall be perpetual, irrevocable, fully paid up and royalty-free. Allogene may terminate the Collaboration Agreement in whole or on a product-by-product basis upon ninety days’ prior written notice to Notch. Either party may also terminate the Collaboration Agreement with written notice upon material breach by the other party, if such breach has not been cured within a defined period of receiving such notice, or in the event of the other party’s insolvency.
For the years ended December 31, 2021, 2020, and 2019, the Company recorded $ 4.3 million, $ 3.2 million, and $ 0.1 million, respectively, in collaboration costs as research and development expenses. For the year ended December 31, 2021, $ 0.3 million in costs were incurred related to the achievement of a research milestone under this agreement.
Strategic Alliance with The University of Texas MD Anderson Cancer Center
On October 6, 2020, the Company entered into a strategic five-year collaboration agreement with The University of Texas MD Anderson Cancer Center (MD Anderson) for the preclinical and clinical investigation of allogeneic CAR T cell product candidates. The Company and MD Anderson are collaborating on the design and conduct of preclinical and clinical studies with oversight from a joint steering committee.
Under the terms of the agreement, the Company has committed up to $ 15.0 million of funding for the duration of the agreement. Payment of this funding is contingent on mutual agreement to study orders in order for any study to be included under the alliance. The Company made an upfront payment of $ 3.0 million to MD Anderson in the year ended December 31, 2020. The Company is obligated to make further payments to MD Anderson each year upon the anniversary of the agreement effective date through the duration of the agreement term. These costs are expensed to research and development as MD Anderson renders the services under the strategic alliance.
The agreement may be terminated by either party for material breach by the other party. Individual studies may be terminated for, among other things, material breach, health and safety concerns or where the institutional review board, the
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review board at the clinical site with oversight of the clinical study, requests termination of any study. Where any legal or regulatory authorization is finally withdrawn or terminated, the relevant study will also terminate automatically.
For the years ended December 31, 2021 and 2020, the Company recorded $ 1.0 million and zero , respectively, in collaboration costs as research and development expenses.
Joint Venture and License Agreement with Allogene Overland Biopharm (CY) Limited
On December 14, 2020, the Company entered into a License Agreement with Allogene Overland Biopharm (CY) Limited (Allogene Overland), a joint venture established by the Company and Overland Pharmaceuticals (CY) Inc. (Overland), pursuant to a Share Purchase Agreement, dated December 14, 2020, for the purpose of developing, manufacturing and commercializing certain allogeneic CAR T cell therapies for patients in greater China, Taiwan, South Korea and Singapore (the JV Territory).
Pursuant to the Share Purchase Agreement, the Company acquired Seed Preferred Shares in Allogene Overland representing 49 % of Allogene Overland's outstanding stock as partial consideration for the License Agreement, and Overland acquired Seed Preferred Shares representing 51 % of Allogene Overland's outstanding stock for $ 117.0 million in upfront and certain quarterly cash payments, to support operations of Allogene Overland. As of December 31, 2021, the Company and Overland are the sole equity holders in Allogene Overland. The Company received $ 40 million from Allogene Overland as partial consideration for the License Agreement.
Pursuant to the License Agreement, the Company granted Allogene Overland an exclusive license to develop, manufacture and commercialize certain allogeneic CAR T cell candidates directed at four targets, BCMA, CD70, FLT3, and DLL3, in the JV Territory. As consideration, the Company would also be entitled to additional regulatory milestone payments of up to $ 40.0 million and, subject to certain conditions, tiered low-to-mid single-digit sales royalties. Subsequent to entering into the License Agreement, Allogene Overland assigned the License Agreement to a wholly-owned subsidiary, Allogene Overland BioPharm (HK) Limited.
Promises that the Company concluded were distinct performance obligations in the License Agreement included: (1) the license of intellectual property and delivery of know-how, (2) the manufacturing license, related know-how and support, (3) if and when available know-how developed in future periods, and (4) participation in the joint steering committee.
In order to determine the transaction price, the Company evaluated all the payments to be received during the duration of the contract. Fixed consideration exists in the form of the upfront payment. Regulatory milestones and royalties were considered variable consideration. The Company constrains the estimated variable consideration when it assesses it is probable that a significant reversal in the amount of cumulative revenue recognized may occur in future periods. Milestone fees were constrained and not included in the transaction price due to the uncertainties of research and development. The Company re-evaluates the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The shares of Series Seed Preferred Stock were accounted for as part of the Company’s joint venture and equity method accounting upon formation of the joint venture, and as such, were excluded from the transaction price. The Company determined that the initial transaction price consists of the upfront payment of $ 40.0 million. The allocation of the transaction price is performed based on standalone selling prices, which are based on estimated amounts that the Company would charge for a performance obligation if it were sold separately . The transaction price allocated to the license of intellectual property and delivery of know-how will be recognized upon grant of license and delivery of know-how. The transaction price allocated to (i) the manufacturing license, related know-how and support services, (ii) if and when available know-how developed in future periods, and (iii) participation in the joint steering committee, will be recognized over time as the services are delivered. Funds received in advance are recorded as deferred revenue and will be recognized as the performance obligations are satisfied.
The Company has determined that Allogene Overland is a variable interest entity as of December 31, 2021 and 2020, respectively. The Company does not have the power to independently direct the activities which most significantly affect Allogene Overland's economic performance. Accordingly, for the years ended December 31, 2021 and 2020, the Company did not consolidate Allogene Overland because the Company determined that it was not the primary beneficiary.
For the years ended December 31, 2021 and 2020, the Company recognized $ 38.5 million and zero , respectively, of collaboration revenue, primarily related to the delivery of a performance obligation consisting of a license of intellectual property and related know-how which was delivered in the first quarter of 2021. For the year ended December 31, 2020, the Company recorded the $ 40.0 million upfront cash payment received from Allogene Overland as deferred revenue, of which $ 39.0 million was current, on the consolidated balance sheet.
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Note 7. Commitments and Contingencies
Leases
In August 2018, the Company entered into an operating lease agreement (HQ Lease) for new office and laboratory space which consists of approximately 68,000 square feet located in South San Francisco, California. The lease term was 127 months beginning August 2018 through February 2029 with an option to extend the term for seven years which was not reasonably assured of exercise. The Company has made certain tenant improvements, including the addition of laboratory space, and has received $ 5.0 million of tenant improvement allowances up to December 31, 2021. The rent payments began on March 1, 2019 after an abatement period. In December 2021, the Company amended its lease agreement to lease an additional 47,566 square feet of office and laboratory space in South San Francisco, California, as part of the same building as the Company’s current headquarters. The lease term is 120 months and is expected to commence in April 2022. The rent payments for the expansion premises are expected to begin in August 2022 after an abatement period. The lease term for the existing premises was also extended and the lease for both the existing and expansion premises will expire on March 31, 2032 with an option to extend the term for eight years which is not reasonably assured of exercise.
In October 2018, the Company entered into an operating lease agreement for new office and laboratory space which consists of 14,943 square feet located in South San Francisco, California. The lease term was 124 months beginning November 2018 through February 2029, with an option to extend the term for another seven years which was not reasonably assured of exercise. The Company has made certain tenant improvements, including the upgrading of current office and laboratory space with a lease incentive allowance of $ 0.8 million. Rent payments began in November 2018. In December 2021, the Company amended its lease agreement to extend the term of the lease to be co-terminus with the HQ Lease. The lease term will expire March 31, 2032 with an option to extend the term for eight years which is not reasonably assured of exercise.
In February 2019, the Company entered into a lease agreement for approximately 118,000 square feet of space to develop a cell therapy manufacturing facility in Newark, California. The lease term is 188 months beginning November 2020 through July 2036. Upon certain conditions, the Company has two ten-year options to extend the lease, both of which are not reasonably assured of exercise. The Company received $ 2.7 million of tenant improvement allowances.
The Company maintains letters of credit for the benefit of landlords which is disclosed as restricted cash in the consolidated balance sheet. Restricted cash related to letters of credit due to landlords was $ 6.0 million and $ 5.2 million as of December 31, 2021 and 2020, respectively.
The balance sheet classification of our lease liabilities were as follows (in thousands):
December 31, 2021 December 31, 2020
Operating lease liabilities
Current portion included in accrued and other current liabilities $ 3,200 $ 2,974
Long-term portion of lease liabilities 69,929 50,809
Total operating lease liabilities $ 73,129 $ 53,783
The components of lease costs for operating leases, which were recognized in operating expenses, were as follows (in thousands):
Twelve Months Ended December 31,
2021 2020 2018
Operating lease cost $ 7,513 $ 7,390 $ 5,945
Variable lease cost 1,629 1,382 1,087
Total lease costs $ 9,142 $ 8,771 $ 7,033
Cash paid for amounts included in the measurement of lease liabilities for the twelve months ended December 31, 2021 was $ 6.0 million and was included in net cash used in operating activities in our consolidated statements of cash flows.
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The undiscounted future non-cancellable lease payments under our operating leases as of December 31, 2021 is as follows:
Year ending December 31: (in thousands)
2022 $ 8,004
2023 8,257
2024 8,523
2025 8,557
2026 and thereafter 74,396
Total undiscounted lease payments 107,737
Less: Present value adjustment ( 34,283 )
Less: Tenant improvement allowance ( 325 )
Total $ 73,129
Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, we use our estimated incremental borrowing rate. The weighted average discount rate used to determine the operating lease liability was 6.34 %. As of December 31, 2021, the weighted average remaining lease term for our operating leases is 11.21 years.
Rent expense for short-term leases was $ 0.3 million, $ 0.2 million and $ 2.4 million for the years ended December 31, 2021, 2020 and 2019 respectively.
Certain lease agreements require the Company to return designated areas of leased space to its original condition upon termination of the lease agreement. At the inception of such leases, the Company records an asset retirement obligation and a corresponding capital asset in an amount equal to the estimated fair value of the obligation. To determine the fair value of the obligation, we estimate the cost for a third-party to perform the restoration work. In subsequent periods, for each asset retirement obligation, the Company records interest expense to accrete the asset retirement obligation liability to full value and depreciate each capitalized asset retirement obligation asset, both over the term of the associated lease agreement. Asset retirement obligations were $ 0.5 million and $ 0.5 million as of December 31, 2021 and 2020 respectively.
Other Commitments
Solar Power Purchase and Energy Services Agreement
In July 2020, the Company entered into a Solar Power Purchase and Energy Services Agreement for the installation and operation of a solar photovoltaic generating system and battery energy storage system at the Company's cell therapy manufacturing facility in Newark, California. The agreement has a term of 20 years and is expected to commence in the first half of 2022. The Company is obligated to pay for electricity generated from the system at an agreed rate for the duration of the agreement term. Termination of the agreement by the Company will result in a termination payment due of approximately $ 4.3 million. In connection with the agreement, the Company maintains a letter of credit for the benefit of the service provider in the amount of $ 4.3 million which is disclosed as restricted cash in the consolidated balance sheets as of December 31, 2021 and 2020.
License Agreements for Intellectual Property
The Company has entered into certain license agreements for intellectual property which is used as part of our development and manufacturing processes. Each of these respective agreements are generally cancellable by the Company. These agreements require payment of annual license fees and may include conditional milestone payments for achievement of specific research, clinical and commercial events, and royalty payments. The timing and likelihood of any significant conditional milestone payments or royalty payments becoming due was not probable as of December 31, 2021.
Purchase Commitments
In the normal course of business, the Company enters into various purchase commitments with third-party contract manufacturers for the manufacture and processing of our product candidates and related raw materials, and we have entered into other contracts in the normal course of business with contract research organizations for clinical trials and other vendors for other services and products for operating purposes. These agreements generally provide for termination or cancellation, other
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than for costs already incurred. As of December 31, 2021, the Company had non-cancellable purchase commitments of $ 3.7 million.
Contingencies
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown, because it involves claims that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
Indemnification
In accordance with the Company’s amended and restated certificate of incorporation and amended and restated bylaws, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims.
Note 8. Equity Method Investments
Notch Therapeutics
In conjunction with the execution of the Notch Agreement (see Note 6), the Company also entered into a Share Purchase Agreement with the Company acquiring shares of Notch’s Series Seed convertible preferred stock for a total investment cost of $ 5.1 million which includes transaction costs of $ 0.1 million, resulting in a 25 % ownership interest in Notch. In February 2021, the Company made a $ 15.9 million investment in Notch's Series A preferred stock. Immediately following this transaction, the Company's share in Notch was 20.7 % on a voting interest basis. In October 2021, the Company made an additional $ 1.8 million investment in Notch's common stock. Immediately following this transaction, the Company's share in Notch was 23.0 % on a voting interest basis.
The Company’s total equity investment in Notch as of December 31, 2021 and 2020 was $ 18.0 million and $ 3.7 million, respectively, based on the cost method of accounting. During the years ended December 31, 2021, 2020 and 2019, the Company recognized its share of Notch's net loss under the other expenses caption within the consolidated statement of operations.
Allogene Overland Biopharm (CY) Limited
In conjunction with the execution of the License Agreement with Allogene Overland (see Note 6), the Company also entered into a Share Purchase Agreement and Shareholders' Agreement with the joint venture company acquiring shares of Allogene Overland’s Seed Preferred Shares representing a 49 % ownership interest in exchange for entering into a License Agreement which had a carrying value of zero . The Company accounts for its investment in Allogene Overland as an equity method investment at carrying value. The Company's total equity investment in Allogene Overland was zero as of December 31, 2021.
The Company’s equity investment in Allogene Overland as of December 31, 2021 had a zero carryover basis. Therefore, the Company did not account for its share of losses incurred by Allogene Overland. See Note 6 for further details.
Note 9. Stockholders’ Equity
Preferred Stock
Pursuant to the Amended and Restated Certificate of Incorporation filed on October 15, 2018, as amended, the Company is authorized to issue a total of 10,000,000 shares of preferred stock, of which no shares were issued and outstanding at December 31, 2021 and 2020.
Common Stock
Pursuant to the Amended and Restated Certificate of Incorporation filed on October 15, 2018, as amended, the Company is authorized to issue a total of 200,000,000 shares of common stock, of which 142,623,065 and 140,474,305 shares were issued and outstanding at December 31, 2021 and 2020, respectively.
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Common stockholders are entitled to dividends if and when declared by the Company’s Board of Directors subject to the prior rights of the preferred stockholders. As of December 31, 2021 and 2020, no dividends on common stock had been declared by the Company’s Board of Directors.
Note 10. Stock-Based Compensation
2018 Equity Incentive Plan
In June 2018, the Company adopted its 2018 Equity Incentive Plan (Prior 2018 Plan). The 2018 Plan provided for the Company to sell or issue common stock or restricted common stock, or to grant incentive stock options or nonqualified stock options for the purchase of common stock, to employees, members of the Company’s Board of Directors and consultants of the Company under terms and provisions established by the Company’s Board of Directors. In September 2018, the Board of Directors adopted a new amended and restated 2018 Equity Incentive Plan as a successor to and continuation of the Prior 2018 Plan, which became effective in October 2018 (the 2018 Plan), which authorized additional shares for issuance and provided for an automatic annual increase to the number of shares issuable under the 2018 Plan by an amount equal to 5 % of the total number of shares of common stock outstanding on December 31 st of the preceding calendar year. The term of any stock option granted under the 2018 Plan cannot exceed 10 years. The Company generally grants stock-based awards with service conditions only. Options granted typically vest over a four-year period but may be granted with different vesting terms. Restricted Stock Units granted typically vest annually over a four-year period but may be granted with different vesting terms. Options shall not have an exercise price less than 100 % of the fair market value of the Company’s common stock on the grant date. If the individual possesses more than 10 % of the combined voting power of all classes of stock of the Company, the exercise price shall not be less than 110 % of the fair market value of a common share of stock on the date of grant. This requirement is applicable to incentive stock options only.
As of December 31, 2021 and 2020, there were 15,801,927 and 12,308,848 shares reserved by the Company under the 2018 Plan for the future issuance of equity awards.
Stock Option Activity
The following summarizes option activity under the 2018 Plan:
Outstanding Options
Number of
Options
Weighted-
Average
Exercise Price
Weighted-
Average
Remaining
Contract
Term
Aggregate
Intrinsic
Value
(in years) (in thousands)
Balance, December 31, 2020 10,434,034 $ 17.73 8.29 $ 93,149
Options granted 2,427,013 29.98
Options exercised ( 1,268,840 ) 10.78 $ 21,917
Options forfeited ( 1,353,040 ) 20.74
Balance, December 31, 2021 10,239,167 $ 21.10 7.68 $ 26,223
Exercisable, December 31, 2021 7,646,675 $ 19.86 7.43 $ 23,819
Vested and expected to vest, December 31, 2021 10,239,167 $ 21.10 7.68 $ 26,223
The aggregate intrinsic values of options exercised, outstanding, exercisable, vested and expected to vest were calculated as the difference between the exercise price of the options and the closing price of the Company’s common stock on the Nasdaq Global Select Market on December 31, 2021. During the years ended December 31, 2021 and 2020, the estimated weighted-average grant-date fair value of employee options granted was $ 18.79 per share and $ 13.79 per share, respectively. As of December 31, 2021 and 2020, there was $ 75.5 million and $ 81.1 million, respectively, of unrecognized stock-based compensation related to unvested stock options, which is expected to be recognized over a weighted-average period of 2 years, 176 days and 2 years, 222 days , respectively.
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The fair value of employee, consultant and director stock option awards was estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions:
Year Ended December 31,
2021 2020
Fair value of common stock $ 15.37 - $ 39.02
$ 18.22 - $ 48.94
Expected term in years 5.27 - 6.25
5.31 - 6.09
Expected volatility 69.73 % - 71.69 %
71.42 % - 72.14 %
Expected risk-free interest rate 0.60 % - 1.40 %
0.31 % - 1.65 %
Expected dividend 0 % 0 %
The Black-Scholes option-pricing model requires the use of subjective assumptions which determine the fair value of stock-based awards. These assumptions include:
Fair value of common stock —For grants before October 2018 when the Company was private and there was no public market for the Company’s common stock, the fair value of the Company’s common stock underlying share-based awards was estimated on each grant date by the Company’s Board of Directors. In order to determine the fair value of the Company’s common stock underlying option grants, the Company’s Board of Directors considered, among other things, valuations of the Company’s common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation . For all grants subsequent to the Company’s IPO in October 2018, the fair value of common stock was determined by taking the closing price per share of common stock per Nasdaq.
Expected term — The expected term represents the period that stock-based awards are expected to be outstanding. The expected term for option grants is determined using the simplified method. The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the stock-based awards.
Expected volatility — The Company uses an average historical stock price volatility of comparable public companies within the biotechnology and pharmaceutical industry that were deemed to be representative of future stock price trends as the Company does not have sufficient trading history for its common stock. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available.
Risk-free interest rate —The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of option.
Expected dividend —The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero.
For the years ended December 31, 2021 and 2020, total stock-based compensation expense related to stock options was $ 38.2 million and $ 31.8 million, respectively.
Restricted Stock Unit Activity
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The following summarizes restricted stock unit activity under the 2018 Plan:
Outstanding Restricted Stock Units
Restricted Stock Units Weighted- Average Grant Date Fair Value per Share Weighted Average Remaining Vesting Life Aggregate Intrinsic Value
(in years) (in thousands)
Unvested December 31, 2020 2,493,920 $ 26.14 1.66 $ 62,947
Granted 3,028,477 26.88 1.87
Vested ( 689,475 ) 26.81
Forfeited ( 571,814 ) 27.54
Unvested December 31, 2021 4,261,108 $ 26.37 1.72 $ 63,576
Vested and expected to vest, December 31, 2021 4,261,108 $ 26.37 1.72 $ 63,576
For the year ended December 31, 2019, the Company granted 57,361 performance based restricted stock units to a certain executive officer pursuant to the 2018 Plan. These performance awards are subject to the holder's continued service to the Company through each applicable vesting event. During the year ended December 31, 2021, the Company determined that the achievement of the first requisite performance condition for these awards was probable, and as a result, recognized $ 0.5 million in stock-based compensation expense related to these awards as of December 31, 2021.
For the years ended December 31, 2021 and 2020, total stock-based compensation expense related to restricted stock units and performance based restricted stock units was $ 26.6 million and $ 17.2 million, respectively. As of December 31, 2021 and 2020, there was $ 90.7 million and $ 51.1 million, respectively, of unrecognized stock-based compensation which is expected to be recognized over a weighted average period of 2.92 years.
Employee Stock Purchase Plan
In October 2018, the shareholders approved the 2018 Employee Stock Purchase Plan (ESPP), which initially reserved 1,160,000 shares of our common stock for employee purchases under terms and provisions established by the Board of Directors. Effective January 1, 2020 and 2019, the number of shares authorized under the ESPP for employee purchases increased by 1,242,673 and 1,214,826 shares respectively. The ESPP is intended to qualify as an ‘employee stock purchase plan’ under Section 423 of the Internal Revenue Code. Under the current offering adopted pursuant to the ESPP, each offering period is approximately 24 months, which is generally divided into four purchase periods of approximately six months.
Employees are eligible to participate if they are employed by the Company. Under the ESPP, employees may purchase common stock through payroll deductions at a price equal to 85 % of the lower of the fair market value of common stock on the first trading day of each offering period or on the purchase date. The ESPP provides for consecutive, overlapping 24 -month offering periods. The offering periods are scheduled to start on the first trading day on or after March 16 or September 16 of each year, except for the first offering period which commenced on October 11, 2018, the first trading day after the effective date of the Company’s registration statement. Contributions under the ESPP are limited to a maximum of 15 % of an employee’s eligible compensation.
The fair values of the rights granted under the ESPP were calculated using the following assumptions:
Year ended December 31,
2021 2020
Expected term (in years) 0.50 – 2.00
0.50 – 2.00
Volatility 59.35 % - 80.00 %
63.88 % - 72.75 %
Risk-free interest rate 0.05 %- 0.23 %
0.12 % - 0.36 %
Dividend yield — —
For the years ended December 31, 2021 and 2020, total stock-based compensation expense related to ESPP was $ 2.3 million and $ 2.5 million, respectively.
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Founders’ Stock
In 2018, the Company’s founders agreed to modify their common shares outstanding to include vesting provisions that require continued service to the Company in order to vest in those shares. Stock-based compensation expense is recognized for shares of founders’ stock as vesting conditions are met. In relation to the modification, 24,230,750 shares of founders’ stock remained unvested at the modification date in April 2018. For the years ended December 31, 2021, 2020 and 2019, $ 13.7 million, $ 13.7 million, and $ 13.7 million of stock-based compensation expense was recognized related to the vesting of 6,057,695 , 6,057,684 , and 6,057,684 shares, respectively, of founders' stock. At December 31, 2021 and 2020, there was $ 3.4 million and $ 17.1 million of unrecognized stock-based compensation expense related to 1,514,424 and 7,572,119 shares of unvested founders’ stock which is expected to be recognized over 3 months and 15 months, respectively. The weighted-average fair value at grant date for founders’ stock was $ 2.27 per share.
Total stock-based compensation expense related to stock options, restricted stock units, employee stock purchase plans and vesting of the founders’ common stock was as follows:
Year Ended December 31,
2021 2020 2019
(in thousands)
Research and development $ 39,611 $ 31,309 $ 19,429
General and administrative 41,207 33,952 26,634
Total stock-based compensation expense $ 80,818 $ 65,261 $ 46,063
Early Exercised Options
The Company allows certain of its employees and its directors to exercise options granted under the Prior 2018 Plan and the 2018 Plan prior to vesting. The shares related to early exercised stock options are subject to the Company’s lapsing repurchase right upon termination of employment or service on the Company’s Board of Directors at the lesser of the original purchase price or fair market value at the time of repurchase. In order to vest, the holders are required to provide continued service to the Company. The proceeds are initially recorded in accrued and other liabilities and other long-term liabilities for the noncurrent portion. The proceeds are reclassified to paid-in capital as the repurchase right lapses. During the years ended December 31, 2021 and 2020, 293,594 and zero options were early exercised. As of December 31, 2021 and 2020, there was $ 2.9 million and $ 2.8 million recorded in accrued and other liabilities and $ 2.5 million and $ 1.1 million recorded in other long-term liabilities related to shares held by employees and directors that were subject to repurchase. The underlying shares are shown as outstanding in the consolidated financial statements since the exercise date but the shares which are subject to future vesting conditions are not included in the calculation of earnings per share.
Note 11. Related Party Transactions
Pfizer Inc.
PF Equity Holdings 2 B.V. held 22,032,040 shares of Common Stock based on the Schedule 13D/A filed on September 17, 2021 with the SEC. According to the Schedule 13D/A filing, PF Equity Holdings 2 B.V. is a wholly-owned subsidiary of Pfizer formed for the purpose of holding certain assets owned or controlled by Pfizer or its direct or indirect subsidiaries.
In April 2018, the Company and Pfizer entered into a transition services agreement (the Pfizer TSA) for Pfizer to provide professional services to the Company related to research and development, project management, and other administrative functions. In September 2019, the Company and Pfizer terminated the Pfizer TSA. For the years ended December 31, 2021 and 2020, zero costs were incurred under the Pfizer TSA. For the year ended December 31, 2019, the costs incurred under the Pfizer TSA were $ 4.5 million.
The Company also purchased certain lab supplies and services from Pfizer in connection with its research and development activities. For the years ended December 31, 2021 and 2020, zero lab supplies and services were purchased from Pfizer. For the year ended December 31, 2019, total lab supplies and services purchased from Pfizer were $ 1.4 million.
During the year ended December 31, 2021, the Company sold $ 0.1 million in excess raw materials to Pfizer.
Collaboration Revenue
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In December 2020, the Company entered into a license agreement with Allogene Overland, a corporate joint venture entity and related party (see Note 6). The license agreement was subsequently assigned to a wholly-owned subsidiary of Allogene Overland, Allogene Overland BioPharm (HK) Limited. During the years ended December 31, 2021 and 2020, the Company recognized $ 38.5 million and zero , respectively, of collaboration revenue under this arrangement.
For the years ended December 31, 2021 and 2020, the Company recorded $ 0.2 million and zero , respectively, of net cost recoveries under the terms of the license agreement as a reduction to research and development expenses.
Consulting Agreements
In June 2018, the Company entered into a services agreement with Two River Consulting LLC (Two River) a firm affiliated with the Company’s President and Chief Executive Officer, the Company’s Executive Chair of the board of directors, and a director of the Company to provide various managerial, clinical development, administrative, accounting and financial services to the Company. The costs incurred for services provided under this agreement were $ 0.6 million, $ 0.4 million and $ 0.6 million for the years ended December 31, 2021, 2020 and 2019, respectively.
In August 2018, the Company entered into a consulting agreement with Bellco Capital LLC (Bellco). Pursuant to the consulting agreement, Bellco provides certain services for the Company, which are performed by Dr. Belldegrun and include without limitation, providing advice and analysis with respect to the Company’s business, business strategy and potential opportunities in the field of allogeneic CAR T cell therapy and any other aspect of the CAR T cell therapy business as the Company may agree. In consideration for these services, the Company paid Bellco $ 33,333 per month in arrears commencing January 2019, $ 37,000 per month in arrears commencing January 2020, and $ 38,583 per month in arrears commencing January 2021. The Company may also, at its discretion, pay Bellco an annual performance award in an amount up to 60 % of the aggregate compensation payable to Bellco in a calendar year. The Company also reimburses Bellco for out of pocket expenses incurred in performing the services. The costs incurred for services provided, bonus and out-of-pocket expenses incurred under this consulting agreement were $ 0.7 million, $ 0.9 million and $ 0.8 million for the years ended December 31, 2021, 2020 and 2019, respectively.
As of December 31, 2021 and 2020, amounts due to Bellco of $ 0.3 million and $ 0.3 million, respectively, were recorded in accrued and other current liabilities in the accompanying consolidated balance sheets.
Sublease Agreements
In December 2018, the Company entered into a sublease with Bellco for 1,293 square feet of office space in Los Angeles, California for a three year term. On April 1, 2020, Bellco Capital Advisors Inc. assumed all rights, title, interests and obligations under the sublease from Bellco Capital LLC. In November 2021, the sublease was extended to June 30, 2025. The Company’s executive chair, Arie Belldegrun, M.D., FACS, is a trustee of the Belldegrun Family Trust, which controls Bellco Capital Advisors Inc. The total right of use asset and associated liability recorded related to this related party lease was $ 0.3 million and $ 0.1 million at December 31, 2021 and 2020, respectively.
In February 2019, the Company subleased 2,180 square feet of its office space in New York, New York, to ByHeart, Inc., formerly known as Second Science, Inc. (ByHeart). ByHeart is a development-stage infant formula company. Certain of the Company’s board members and executive officers have beneficial ownership in ByHeart and two serve on the board of directors of ByHeart. In September 2019, the Company entered into an amendment to the sublease agreement and increased the subleased space to 2,907 square feet. In October 2020, the sublease agreement between the Company and ByHeart was terminated. Sublease income for the years ended December 31, 2021 and 2020 was zero and $ 0.3 million, respectively, and was recognized as other income.
Note 12. 401(k) Plan
In April 2018, the Company began to sponsor a 401(k) retirement savings plan for the benefit of its employees. All employees are eligible to participate, provided they meet the requirements of the plan. The Company made contributions to the plan for eligible participants, and recorded contribution expenses of $ 1.8 million, $ 1.4 million and $ 0.9 million related to matched contributions for the years ended December 31, 2021, 2020 and 2019, respectively.
Note 13. Income Taxes
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The Company has incurred net operating losses for all the periods presented. The Company has not reflected any benefit of such net operating loss carryforwards in the accompanying consolidated financial statements.
The Company has established a full valuation allowance against its deferred tax assets due to the uncertainty surrounding the realization of such assets.
Year Ended December 31,
2021 2020 2019
Current: (in thousands)
Federal $ — $ — $ —
State — — 1
— — 1
Deferred:
Federal — — ( 251 )
State — — ( 81 )
— — ( 332 )
Benefit for income taxes $ — $ — $ ( 331 )
Reconciliation of the benefit for income taxes calculated at the statutory rate to our benefit for income taxes is as follows:
Year Ended December 31,
2021 2020 2019
(in thousands)
Tax benefit at federal statutory rate $ ( 53,971 ) $ ( 52,546 ) $ ( 38,834 )
State taxes, net of federal benefit 806 ( 18,656 ) ( 12,951 )
Stock-based compensation 4,534 997 2,037
Research tax credits ( 2,942 ) ( 2,319 ) ( 1,714 )
Change in valuation allowance 52,265 72,538 49,989
Other ( 692 ) ( 14 ) 1,142
Benefit for incomes taxes $ — $ — $ ( 331 )
Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards.
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Significant components of our deferred tax assets and liabilities are as follows:
Year Ended December 31,
2021 2020 2019
(in thousands)
Deferred tax assets:
Net operating loss carryforwards $ 162,996 $ 115,199 $ 54,018
Tax credit carryforwards 15,595 8,297 4,239
Intangibles 14,648 20,582 22,770
Accrued expenses 3,213 3,888 2,375
Lease liabilities 16,344 15,050 14,839
Stock based compensation 15,273 12,970 6,870
Investments 1,543 175 —
Other 358 12 —
Total deferred tax assets 229,970 176,173 105,111
Deferred tax liabilities:
Fixed assets ( 219 ) ( 172 ) ( 361 )
Right of use leased assets ( 12,969 ) ( 11,556 ) ( 12,453 )
Investments — — ( 393 )
Other ( 71 ) — —
Total deferred tax liabilities ( 13,259 ) ( 11,728 ) ( 13,207 )
Net deferred tax assets 216,711 164,445 91,904
Valuation allowance ( 216,711 ) ( 164,445 ) ( 91,904 )
Net deferred tax assets $ — $ — $ —
Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Due to the lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by approximately $ 52.3 million, $ 72.5 million and $ 50.0 million during the years ended December 31, 2021, 2020 and 2019, respectively.
The following table sets forth our federal and state NOL carryforwards and federal research and development tax credits as of December 31, 2021:
Amount Expiration
(in thousands)
Net operating losses, federal $ 628,232 Indefinite
Net operating losses, federal $ 2 2037
Net operating losses, state $ 444,859 2037-2041
Tax credits, federal $ 12,805 2038-2041
Tax credits, state $ 11,691 Indefinite
California Competes Tax credits, state $ 3,000 2026
Current federal and California tax laws include substantial restrictions on the utilization of NOLs and tax credit carryforwards in the event of an ownership change of a corporation. Accordingly, the Company's ability to utilize NOLs and tax credit carryforwards may be limited as a result of such ownership changes. Such a limitation could result in the expiration of carryforwards before they are utilized.
In December 2019, the FASB issued Accounting Standards Update No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (ASU 2019-12), which simplifies the accounting for income taxes, eliminates certain exceptions within ASC 740, Income Taxes, and clarifies certain aspects of the current guidance to promote consistency among reporting entities. This guidance was effective for the Company in the first quarter of 2021 on a prospective basis, and early adoption was permitted. The Company early adopted this standard as of January 1, 2020 on a prospective basis in accordance with ASC 250, Accounting Changes and Error Corrections. The adoption resulted in the Company no longer
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needing to determine the tax effect from unrealized gains on available for sale securities, which previously had been disclosed in the consolidated statement of operations as a benefit from income taxes. The impact of the adoption is that the benefit from income taxes in the consolidated statement of operations and comprehensive loss is zero. For the years ended December 31, 2021 and 2020, the Company recorded a tax benefit of zero . For the year ended December 31, 2019, the Company recorded a tax benefit of $ 0.3 million, in other comprehensive income, related to available-for-sale securities.
We apply the provisions of ASC Topic 740 to account for uncertain income tax positions. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows:
December 31,
2021 2020 2019
(in thousands)
Balance at beginning of the year: $ 6,161 $ 3,148 $ 920
Additions based on tax positions related to current year 3,637 3,013 2,228
Additions to tax position of prior year — — —
Reductions to tax position of prior years — — —
Lapse of the applicable statute of limitations — — —
Balance at end of the year $ 9,798 $ 6,161 $ 3,148
It is the Company’s policy to include penalties and interest expense related to income taxes as a component of interest and other income, net, as necessary. As of December 31, 2021, 2020 and 2019, there were no accrued interest and penalties related to uncertain tax positions. The reversal of the uncertain tax benefits would not affect the effective tax rate to the extent that the Company continues to maintain a full valuation allowance against its deferred tax assets. Unrecognized tax benefits may change during the next 12 months for items that arise in the ordinary course of business. We are subject to examination by U.S. federal or state tax authorities for all years since inception.
Note 14. Net Loss and Net Loss Per Share
The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share data):
Year Ended December 31,
2021 2020 2019
Numerator:
Net loss $ ( 257,005 ) $ ( 250,221 ) $ ( 184,594 )
Denominator:
Weighted average common shares outstanding 135,820,386 120,370,177 101,061,149
Net loss per share, basic and diluted $ ( 1.89 ) $ ( 2.08 ) $ ( 1.83 )
Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive securities would have been anti-dilutive. Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows:
Year Ended December 31,
2021 2020 2019
Stock options to purchase common stock 10,239,167 10,434,034 9,190,522
Restricted stock units subject to vesting 4,261,108 2,493,920 1,941
Expected shares purchased under Employee Stock Purchase Plan 474,966 312,750 195,161
Founder shares subject to future vesting 1,514,424 7,572,119 13,629,803
Early exercised stock options subject to future vesting 720,321 1,737,137 2,992,290
Total 17,209,986 22,549,960 27,948,931
Note 15. Subsequent Events
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On January 5, 2022, the Company entered into an exclusive collaboration and global license agreement (Antion Collaboration and License Agreement) with Antion Biosciences SA (Antion) for Antion’s miRNA technology (miCAR), to advance multiplex gene silencing as an additional tool to develop next generation allogeneic CAR T products. Pursuant to the agreement, Antion will exclusively collaborate with the Company on oncology products for a defined period. The Company will also have exclusive worldwide rights to commercialize products incorporating Antion technology developed during the collaboration.
The Antion Collaboration and License Agreement includes an exclusive research collaboration to conduct research and development of the use of Antion’s proprietary technologies to produce certain products for a defined period, which will be conducted in accordance with an agreed research plan and budget under the oversight of a joint steering committee. The Company will reimburse Antion's costs incurred in accordance with such plan and budget.
In connection with the execution of the Antion Collaboration and License Agreement, the Company made an upfront payment to Antion of $ 3.3 million. In addition, the Company made a $ 3.0 million investment in Antion's preferred stock. In connection with this investment, a Company representative was appointed to Antion’s Board of Directors.
Under the Antion Collaboration and License Agreement, Antion will be eligible to receive up to $ 35.3 million for four products upon achievement of certain development and regulatory milestones. For each additional product, Antion will be eligible to receive $ 2.0 million upon achievement of a regulatory milestone. Antion is also entitled to receive a low single-digit royalty on the Company’s sales of licensed products, subject to certain reductions .
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.