Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 30, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 000-30171 | |
Entity Registrant Name | SANGAMO THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 68-0359556 | |
Entity Address, Address Line One | 7000 Marina Blvd. | |
Entity Address, City or Town | Brisbane | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94005 | |
City Area Code | 510 | |
Local Phone Number | 970-6000 | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Trading Symbol | SGMO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 177,346,980 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001001233 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 56,514 | $ 100,444 |
Total marketable securities | 75,597 | 177,188 |
Interest receivable | 602 | 794 |
Accounts receivable | 1,148 | 3,678 |
Prepaid expenses and other current assets | 13,715 | 18,223 |
Total current assets | 147,576 | 300,327 |
Marketable securities, non-current | 0 | 29,845 |
Property and equipment, net | 28,436 | 63,531 |
Intangible assets | 0 | 50,729 |
Goodwill | 0 | 37,552 |
Operating lease right-of-use assets | 27,211 | 62,002 |
Other non-current assets | 14,974 | 17,023 |
Restricted cash | 1,500 | 1,500 |
Total assets | 219,697 | 562,509 |
Current liabilities: | ||
Accounts payable | 15,457 | 22,418 |
Accrued compensation and employee benefits | 17,306 | 21,506 |
Other accrued liabilities | 14,234 | 16,007 |
Deferred revenues | 1,485 | 51,780 |
Total current liabilities | 48,482 | 111,711 |
Deferred revenues, non-current | 0 | 109,377 |
Long-term portion of lease liabilities | 34,975 | 38,986 |
Deferred income tax | 0 | 6,270 |
Other non-current liabilities | 1,318 | 1,207 |
Total liabilities | 84,775 | 267,551 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Common stock | 1,773 | 1,668 |
Additional paid-in capital | 1,485,811 | 1,450,239 |
Accumulated deficit | (1,346,081) | (1,148,545) |
Accumulated other comprehensive loss | (6,581) | (8,404) |
Total stockholders’ equity | 134,922 | 294,958 |
Total liabilities and stockholders’ equity | $ 219,697 | $ 562,509 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Revenues | $ 9,398,000 | $ 26,460,000 | $ 174,190,000 | $ 84,069,000 |
Operating expenses: | ||||
Research and development | 57,089,000 | 65,116,000 | 183,351,000 | 183,719,000 |
General and administrative | 13,918,000 | 16,238,000 | 48,068,000 | 46,239,000 |
Impairment of goodwill and indefinite-lived intangible assets | 0 | 0 | 89,485,000 | 0 |
Impairment of long-lived assets | 44,799,000 | 0 | 65,232,000 | 0 |
Total operating expenses | 115,806,000 | 81,354,000 | 386,136,000 | 229,958,000 |
Loss from operations | (106,408,000) | (54,894,000) | (211,946,000) | (145,889,000) |
Interest and other income, net | 3,515,000 | 1,769,000 | 9,610,000 | 5,754,000 |
Loss before income taxes | (102,893,000) | (53,125,000) | (202,336,000) | (140,135,000) |
Income tax expense (benefit) | 1,270,000 | 30,000 | (4,800,000) | 170,000 |
Net loss | $ (104,163,000) | $ (53,155,000) | $ (197,536,000) | $ (140,305,000) |
Basic net loss per share (in dollars per share) | $ (0.59) | $ (0.34) | $ (1.14) | $ (0.93) |
Diluted net loss per share (in dollars per share) | $ (0.59) | $ (0.34) | $ (1.14) | $ (0.93) |
Shares used in computing basic net loss per share (in shares) | 177,171 | 158,042 | 173,375 | 150,850 |
Shares used in computing diluted net loss per share (in shares) | 177,171 | 158,042 | 173,375 | 150,850 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (104,163) | $ (53,155) | $ (197,536) | $ (140,305) |
Foreign currency translation adjustment | (1,144) | (6,028) | 981 | (14,040) |
Net pension gain | 5 | 55 | 2 | 130 |
Unrealized gain (loss) on marketable securities, net of tax | 494 | 135 | 840 | (1,101) |
Comprehensive loss | $ (104,808) | $ (58,993) | $ (195,713) | $ (155,316) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income |
Beginning balance (in shares) at Dec. 31, 2021 | 145,921,530 | ||||
Beginning balance at Dec. 31, 2021 | $ 375,343 | $ 1,459 | $ 1,334,138 | $ (956,267) | $ (3,987) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock in at-the-market offering, net of offering expenses (in shares) | 14,711,770 | ||||
Issuance of common stock in at-the-market offering, net of offering expenses | 66,448 | $ 147 | 66,301 | ||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units, net of tax (in shares) | 925,455 | ||||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units, net of tax | (1,838) | $ 9 | (1,847) | ||
Issuance of common stock under employee stock purchase plan (in shares) | 359,468 | ||||
Issuance of common stock under employee stock purchase plan | 1,115 | $ 4 | 1,111 | ||
Stock-based compensation | 23,402 | 23,402 | |||
Foreign currency translation adjustment | (14,040) | (14,040) | |||
Net pension gain | 130 | 130 | |||
Net unrealized (loss) gain on marketable securities, net of tax | (1,101) | (1,101) | |||
Net loss | (140,305) | (140,305) | |||
Ending balance (in shares) at Sep. 30, 2022 | 161,918,223 | ||||
Ending balance at Sep. 30, 2022 | 309,154 | $ 1,619 | 1,423,105 | (1,096,572) | (18,998) |
Beginning balance (in shares) at Jun. 30, 2022 | 153,352,502 | ||||
Beginning balance at Jun. 30, 2022 | 318,281 | $ 1,534 | 1,373,324 | (1,043,417) | (13,160) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock in at-the-market offering, net of offering expenses (in shares) | 8,483,104 | ||||
Issuance of common stock in at-the-market offering, net of offering expenses | 42,174 | $ 85 | 42,089 | ||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units, net of tax (in shares) | 82,617 | ||||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units, net of tax | (101) | $ 0 | (101) | ||
Stock-based compensation | 7,793 | 7,793 | |||
Foreign currency translation adjustment | (6,028) | (6,028) | |||
Net pension gain | 55 | 55 | |||
Net unrealized (loss) gain on marketable securities, net of tax | 135 | 135 | |||
Net loss | (53,155) | (53,155) | |||
Ending balance (in shares) at Sep. 30, 2022 | 161,918,223 | ||||
Ending balance at Sep. 30, 2022 | 309,154 | $ 1,619 | 1,423,105 | (1,096,572) | (18,998) |
Beginning balance (in shares) at Dec. 31, 2022 | 166,793,320 | ||||
Beginning balance at Dec. 31, 2022 | 294,958 | $ 1,668 | 1,450,239 | (1,148,545) | (8,404) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock in at-the-market offering, net of offering expenses (in shares) | 8,249,261 | ||||
Issuance of common stock in at-the-market offering, net of offering expenses | 15,106 | $ 83 | 15,023 | ||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units, net of tax (in shares) | 1,481,508 | ||||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units, net of tax | (1,404) | $ 15 | (1,419) | ||
Issuance of common stock under employee stock purchase plan (in shares) | 755,586 | ||||
Issuance of common stock under employee stock purchase plan | 719 | $ 7 | 712 | ||
Stock-based compensation | 21,256 | 21,256 | |||
Foreign currency translation adjustment | 981 | 981 | |||
Net pension gain | 2 | 2 | |||
Net unrealized (loss) gain on marketable securities, net of tax | 840 | 840 | |||
Net loss | (197,536) | (197,536) | |||
Ending balance (in shares) at Sep. 30, 2023 | 177,279,675 | ||||
Ending balance at Sep. 30, 2023 | 134,922 | $ 1,773 | 1,485,811 | (1,346,081) | (6,581) |
Beginning balance (in shares) at Jun. 30, 2023 | 177,074,546 | ||||
Beginning balance at Jun. 30, 2023 | 233,642 | $ 1,771 | 1,479,725 | (1,241,918) | (5,936) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units, net of tax (in shares) | 205,129 | ||||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units, net of tax | (101) | $ 2 | (103) | ||
Stock-based compensation | 6,189 | 6,189 | |||
Foreign currency translation adjustment | (1,144) | (1,144) | |||
Net pension gain | 5 | 5 | |||
Net unrealized (loss) gain on marketable securities, net of tax | 494 | 494 | |||
Net loss | (104,163) | (104,163) | |||
Ending balance (in shares) at Sep. 30, 2023 | 177,279,675 | ||||
Ending balance at Sep. 30, 2023 | $ 134,922 | $ 1,773 | $ 1,485,811 | $ (1,346,081) | $ (6,581) |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Activities: | ||
Net loss | $ (197,536,000) | $ (140,305,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Impairment of goodwill and indefinite-lived intangible assets | 89,485,000 | 0 |
Impairment of long-lived assets | 65,232,000 | 0 |
Depreciation and amortization | 13,238,000 | 8,765,000 |
Accretion of discounts and impairment on marketable securities | (2,031,000) | (324,000) |
Amortization in operating lease right-of-use assets | 5,945,000 | 6,357,000 |
Deferred income tax benefit | (6,195,000) | 0 |
Stock-based compensation | 21,256,000 | 23,402,000 |
Other non-cash adjustments | 1,119,000 | 0 |
Net changes in operating assets and liabilities: | ||
Interest receivable | 192,000 | (175,000) |
Accounts receivable | 2,530,000 | 1,491,000 |
Prepaid expenses and other assets | 5,159,000 | (5,848,000) |
Accounts payable and other accrued liabilities | (5,220,000) | 9,443,000 |
Accrued compensation and employee benefits | (4,182,000) | (1,225,000) |
Deferred revenues | (159,671,000) | (64,956,000) |
Lease liabilities | (3,737,000) | (3,298,000) |
Other non-current liabilities | 112,000 | 95,000 |
Net cash used in operating activities | (174,304,000) | (166,578,000) |
Investing Activities: | ||
Purchases of marketable securities | (59,551,000) | (225,621,000) |
Maturities of marketable securities | 193,858,000 | 254,990,000 |
Purchases of property and equipment | (18,484,000) | (12,697,000) |
Net cash provided by investing activities | 115,823,000 | 16,672,000 |
Financing Activities: | ||
Taxes paid related to net share settlement of equity awards | (1,404,000) | (1,962,000) |
Proceeds from exercise of stock options | 0 | 124,000 |
Net cash provided by financing activities | 14,421,000 | 65,125,000 |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | 130,000 | 479,000 |
Net decrease in cash, cash equivalents, and restricted cash | (43,930,000) | (84,302,000) |
Cash, cash equivalents, and restricted cash, beginning of period | 101,944,000 | 180,372,000 |
Cash, cash equivalents, and restricted cash, end of period | 58,014,000 | 96,070,000 |
Supplemental cash flow disclosures: | ||
Property and equipment included in unpaid liabilities | 2,757,000 | 3,927,000 |
Tenant improvement allowance included in contra-lease liability | 0 | 1,531,000 |
At the Market Offering | ||
Financing Activities: | ||
Proceeds from at-the-market offering/ issuance of common stock | 15,106,000 | 65,848,000 |
Employee Stock | ||
Financing Activities: | ||
Proceeds from at-the-market offering/ issuance of common stock | $ 719,000 | $ 1,115,000 |
ORGANIZATION, BASIS OF PRESENTA
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization and Description of Business Sangamo Therapeutics, Inc. (“Sangamo” or “the Company”) was incorporated in the State of Delaware in June 1995 and changed its name from Sangamo Biosciences, Inc. in January 2017. Sangamo is a clinical-stage genomic medicine company committed to translating ground-breaking science into medicines that transform the lives of patients with serious diseases. Basis of Presentation The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of these financial statements for the periods presented have been included. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. The Condensed Consolidated Balance Sheet data at December 31, 2022 was derived from the audited Consolidated Financial Statements included in Sangamo’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Annual Report”) as filed with the SEC on February 23, 2023. The accompanying Condensed Consolidated Financial Statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated in the Condensed Consolidated Financial Statements. The accompanying Condensed Consolidated Financial Statements and related financial information should be read together with the audited Consolidated Financial Statements and footnotes for the year ended December 31, 2022, included in the 2022 Annual Report. Liquidity, Going Concern, and Capital Resources Sangamo is currently working on a number of long-term development projects that involve experimental technologies. The projects will require several years and substantial expenditures to complete and ultimately may be unsuccessful. In recent years, the Company’s operations have been funded primarily through collaborations and strategic partnerships, research grants and from the issuance of equity securities. As of September 30, 2023, the Company had capital resources of $132.1 million consisting of cash, cash equivalents, and marketable securities. Under Accounting Standard Codification Topic 205-40, Presentation of Financial Statements—Going Concern (“ASC Topic 205-40”), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the Condensed Consolidated Financial Statements are issued. As required under ASC Topic 205-40, management’s evaluation should initially not take into consideration the potential mitigating effects of management’s plans that have not been fully implemented as of the date the Condensed Consolidated Financial Statements are issued. When substantial doubt exists, management evaluates whether the mitigating effects of its plans sufficiently alleviates the substantial doubt about the Company’s ability to continue as a going concern. The mitigating effects of management’s plans, however, are only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans must have been approved by the Company’s board of directors before the date that the financial statements are issued. The Company’s history of significant losses, its negative cash flows from operations, its limited liquidity resources currently on hand, and its dependence on additional financing to fund its operations after the current resources are exhausted raise substantial doubt about its ability to continue to operate as a going concern within one year after the date that the Condensed Consolidated Financial Statements are issued. The Company’s current operating plan, its cash, cash equivalents, and marketable securities as of September 30, 2023 are expected to allow the Company to meet its liquidity requirements only into the third quarter of 2024, which is less than one year following the date these Condensed Consolidated Financial Statements are issued. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent upon future events, including obtaining adequate financing to support the Company’s cost structure and operating plan. Management’s plans include, among other things, pursuing one or more of the following steps to raise additional capital and reduce costs, none of which can be guaranteed or are entirely within the Company’s control: • raise funding through the sale of the Company’s common stock; • raise funding through debt or royalty financing; and • establish collaborations with potential partners to advance the Company’s product pipeline. If the Company is unable to raise capital on acceptable terms, or at all, or if it is unable to procure collaboration arrangements or external direct investments to advance its programs, the Company would be required to discontinue some or all of its operations or develop and implement a plan to further extend payables, reduce overhead or scale back its current operating plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan would be successful. Additional capital may not be available to the Company on a timely basis, on terms that are acceptable or at all. In particular, the perception of the Company’s ability to continue to operate as a going concern may make it more difficult to obtain financing for the continuation of its operations, particularly in light of currently challenging macroeconomic and market conditions. Further, the Company may be unable to attract new investments as a result of the speculative nature of its newly reprioritized core neurology preclinical programs. If adequate funds are not available to the Company on a timely basis, or at all, the Company will be required to take additional actions to address its liquidity needs, including additional cost reduction measures such as further reducing operating expenses and delaying, reducing the scope of, discontinuing or altering its research and development activities, which would have a material adverse effect on its business and prospects, or the Company may be required to cease operations entirely, liquidate all or a portion of its assets, and/or or seek protection under applicable bankruptcy laws. The accompanying Condensed Consolidated Financial Statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. The Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern. Summary of Significant Accounting Policies Use of Estimates The preparation of Condensed Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the Condensed Consolidated Financial Statements and the accompanying notes. On an ongoing basis, management evaluates its estimates including critical accounting policies or estimates related to revenue recognition, clinical trial accruals, income taxes, fair value of assets and liabilities, including from acquisitions, useful lives and impairment of long-lived assets, and stock-based compensation. Estimates are based on historical experience and on various other market specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. In March 2023, the Company recorded additional revenue related to a change in estimate in connection with the collaboration agreement with Kite Pharma, Inc., a Gilead Sciences, Inc. subsidiary (“Kite”). This adjustment was driven by a reduction in the estimated future level of the Company’s research and development services and as a result, future project costs. This resulted in an increase in proportional cumulative performance on this collaboration and an increase in revenue of $8.9 million, a decrease in net loss of $8.9 million, and a decrease in the Company’s basic and diluted net loss per share of $0.05 for the nine months ended September 30, 2023. In September 2023, the Company recorded additional revenue related to a change in estimate in connection with the collaboration agreement with Kite. This adjustment was driven by a further reduction in the estimated future level of the Company’s research and development services and as a result, future project costs. This resulted in an increase in proportional cumulative performance on this collaboration and increased revenue by $4.9 million, decreased net loss by $4.9 million, and decreased the Company's basic and diluted net loss per share by $0.03 for the three and nine months ended September 30, 2023. Revenue Recognition The Company accounts for its revenues pursuant to the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”). The Company’s contract revenues are derived from collaboration agreements including licensing arrangements and research services. Research and licensing agreements typically include nonrefundable upfront signing or license fees, payments at negotiated rates for time incurred by Company researchers, third-party cost reimbursements, additional target selection fees, sublicense fees, milestone payments tied to ongoing development and product commercialization, and royalties on future licensees’ product sales. All funds received from the Company’s collaboration partners are generally not refundable. Non-refundable upfront fees are fixed at the commencement of the contract. All other fees represent variable consideration in contracts. One of the Company’s contracts also contains a provision where the Company reimburses its customer for certain costs they incur which is accounted for as a reduction to the contract transaction price as the Company does not acquire any distinct goods or services in exchange for such payments. Deferred revenue primarily represents the portion of nonrefundable upfront fees or milestone payments received but not earned. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Most of the Company’s performance obligations in its collaboration agreements represent distinct bundles of licenses of intellectual property and research and development services, with these components being individually non-distinct. Options to license the Company’s intellectual property and/or acquire research and development services also represent performance obligations when they grant customers a material right, e.g., a right to a discount the customer would not have received if they did not purchase the Company’s services under the existing contract. Revenues from bundles of licenses of intellectual property and research and development services are recognized over time using a proportional performance method. Under this method, revenue is recognized by measuring progress towards satisfaction of the relevant performance obligation using a measure that best depicts the progress towards satisfaction of the relevant performance obligation. For most of the Company’s agreements the measure of progress is an input measure based on a level of effort incurred, which includes the value of actual time by Company researchers plus third-party cost reimbursements. Consideration allocated to options that include material rights is deferred until the options are exercised or expire. The exercise of such options is accounted for as contract continuation, with target selection fees and estimated variable consideration included in the transaction price at that time and allocated specifically to the respective target’s performance obligation. Significant management judgment is required to determine the level of effort required under an arrangement, and the period over which the Company expects to complete its performance obligations under the arrangement. Changes in these estimates can have a material effect on revenue recognized. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. For variable consideration, the amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. A cumulative catch-up is then recorded in the current period to reflect the updated transaction price and the updated measure of progress. The estimated period of performance and level of effort, including the value of Company researchers’ time and third-party costs, are reviewed quarterly and adjusted, as needed, to reflect the Company’s current expectations. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, discount rates and probabilities of exercise of technical and regulatory success, and the expected level of effort for research and development services. Contract modifications occur when the price and/or scope of an arrangement changes. If the modification consists of adding new distinct goods or services in exchange for consideration that reflects standalone selling prices of these goods and services, the modification is accounted for as a separate contract with the customer. Otherwise, if the remaining goods and services are distinct from those previously provided, the existing contract is considered terminated, and the remaining consideration is allocated to the remaining goods and services as if this was a newly signed contract. If the remaining goods and services are not distinct from those previously provided, the effects of the modification are accounted for in a manner similar to the effect of a change in the estimated measure of progress, with cumulative catch-up in revenue recorded at the time of the modification. If some of the remaining goods and services are distinct from those previously provided and others are not, to account for the effects of the modification the Company applies principles consistent with the objectives of the modification accounting. Revenues from collaboration and licensing agreements as a percentage of total revenues were as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Kite Pharma, Inc. 58 % 26 % 11 % 23 % Biogen MA, Inc. 4 % 36 % 77 % 36 % Novartis Institutes for BioMedical Research, Inc. — % 36 % 7 % 35 % Other licensing agreements 38 % 2 % 5 % 6 % Impairment of Goodwill, Indefinite-lived Intangible Assets and Long-lived Assets Goodwill represents the excess of consideration transferred over the fair values of assets acquired and liabilities assumed in a business combination. Intangible assets with indefinite useful lives are related to acquired in-process research and development (“IPR&D”) projects and are initially measured at their respective fair values as of the acquisition date. Goodwill and indefinite-lived intangible assets are not amortized. Intangible assets related to IPR&D projects are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point in time. Goodwill and indefinite-lived intangible assets are assessed for impairment on an annual basis and whenever events and circumstances indicate that these assets may be impaired. The Company evaluates the carrying value of long-lived assets, which include property and equipment, leasehold improvements and right-of-use assets, for impairment whenever events or changes in circumstances indicate that the carrying amounts of the asset may not be fully recoverable. In testing for goodwill impairment, the Company has the option of first performing a qualitative assessment to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If the Company elects to bypass the qualitative assessment, or if a qualitative assessment indicates it is more likely than not that the carrying value exceeds its fair value, the Company performs a quantitative goodwill impairment test to compare the fair value of its reporting unit to its carrying value, including goodwill. If the carrying value, including goodwill, exceeds the reporting unit’s fair value, the Company will recognize an impairment loss for the amount by which the carrying amount exceeds the reporting unit’s fair value (but not in excess of the carrying value of goodwill). In performing each annual impairment assessment and any interim impairment assessment for its indefinite-lived intangible assets, the Company determines if it should qualitatively assess whether it is more likely than not the fair value of its IPR&D asset is less than its carrying amount (the qualitative impairment test). If the Company concludes that is the case, or elects not to use the qualitative impairment test, the Company will proceed with quantitatively determining the fair value of the IPR&D asset and comparing its fair value to its carrying value to determine the amount of impairment, if any (the quantitative impairment test). In performing the qualitative impairment test, the Company considers the results of the most recent quantitative impairment test and identifies the most relevant drivers of the fair value for the IPR&D asset. The most relevant drivers of fair value identified are consistent with the assumptions used in the quantitative estimate of the IPR&D asset. Using these drivers of fair value, the Company identifies events and circumstances which may have an effect on the fair value of the IPR&D asset since the last time the IPR&D’s fair value was quantitatively determined. The Company then weighs these factors to determine and conclude if it is not more likely than not the IPR&D asset is impaired. If it is more likely than not the IPR&D asset is impaired, the Company proceeds with quantitatively determining the fair value of the IPR&D asset. When performing the quantitative impairment test, the Company uses the income approach to determine the fair value of its IPR&D asset. This approach calculates fair value by estimating the after-tax cash flows attributable to an in-process project over its useful life and then discounting these after-tax cash flows back to a present value. This estimate includes judgmental assumptions regarding the estimates that market participants would make in evaluating the IPR&D asset, including the probability of successfully completing clinical trials and obtaining regulatory approval to market the IPR&D asset, the timing of and the expected costs to complete IPR&D projects, future net cash flows from potential drug sales, which are based on estimates of the sales price of the drug, the size of the patient population and cure rate, its competitive position in the marketplace, and appropriate discount and tax rates. Any impairment to be recorded is calculated as the difference between the estimated fair value and the carrying value of the IPR&D asset on the Company’s Condensed Consolidated Balance Sheet. If a change in circumstance occurs that indicates long-lived assets may be impaired, the Company performs a test of recoverability by comparing the carrying value of the asset or asset group to its undiscounted expected future cash flows. The long-lived asset evaluation is performed at the asset group level, i.e., the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities. If this review indicates that the carrying amount of the asset group is not recoverable, an impairment loss is measured as the amount by which the carrying amount of an asset group exceeds its fair value. Any impairment loss is allocated to the long-lived assets of the group on a pro rata basis using the relative carrying amounts of those assets, except that the carrying amount of an individual asset shall not be reduced below its fair value. Factors that may indicate potential impairment and trigger an impairment test include, but are not limited to, general macroeconomic conditions, conditions specific to the industry and market, an adverse change in legal factors, impairment of goodwill or indefinite-lived intangible assets, business climate or operational performance of the business, and sustained decline in the stock price and market capitalization compared to the net book value. Calculating the fair value of a reporting unit, an asset group and an individual asset involves significant estimates and assumptions. These estimates and assumptions include, among others, projected future cash flows, risk-adjusted discount rates, future economic and market conditions, and the determination of appropriate market comparables. Changes in these factors and assumptions used can materially affect the amount of impairment loss recognized in the period the asset was considered impaired. Cash, Cash Equivalents, and Restricted Cash Sangamo considers all highly liquid investments purchased with original maturities of three months or less at the purchase date to be cash equivalents. Cash and cash equivalents consist of cash, deposits in demand money market accounts and U.S. government-sponsored entity debt securities. Restricted cash consists of a letter of credit for $1.5 million, representing a deposit for the lease of the corporate headquarters in Brisbane, California. A reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets to the amounts reported within the accompanying Condensed Consolidated Statements of Cash Flows is as follows (in thousands): September 30, December 31, September 30, December 31, Cash and cash equivalents $ 56,514 $ 100,444 $ 94,570 $ 178,872 Non-current restricted cash 1,500 1,500 1,500 1,500 Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows $ 58,014 $ 101,944 $ 96,070 $ 180,372 Marketable Securities Sangamo classifies its marketable securities as available-for-sale and records its investments at estimated fair value based on quoted market prices or observable market inputs of almost identical assets, with the unrealized holding gains and losses included in accumulated other comprehensive income (loss) (“AOCI”). The Company classifies those investments that are not required for use in current operations and that mature in more than 12 months as non-current marketable securities in the accompanying Condensed Consolidated Balance Sheets. The Company’s investments are subject to a periodic impairment review. The Company considers various factors in determining whether to recognize an impairment charge, including the length of time and extent to which the fair value has been less than the cost basis, the Company's financial condition and its intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. Realized gains and losses on marketable securities are included in interest and other income, net, which are determined using the specific identification method. Credit losses related to the marketable securities are recorded in interest and other income, net in the Condensed Consolidated Statements of Operations through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. If the Company intends to sell, or if it is more likely than not that the Company will be required to sell, a security before recovery of its amortized cost basis, the allowance for credit losses is written off, and the amortized cost of the security is written down to its fair value, with an impairment charge recognized. This also results in a reversal of any unrealized gains and losses for this security that were previously included in AOCI. Impairment charges are included in interest and other income, net in the Condensed Consolidated Statements of Operations. Leases The Company determines if an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether it has the right to control the identified asset. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. Right-of-use assets are based on the measurement of the lease liability and also include any lease payments made prior to or on lease commencement and exclude lease incentives and initial direct costs incurred, as applicable. As the implicit rate in the Company’s leases is generally unknown, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of remaining lease payments. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease in a similar economic environment. The Company considers its credit risk, term of the lease, and total lease payments and adjusts for the impacts of collateral, as necessary, when calculating its incremental borrowing rates. The lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise any such options. Rent expense for the Company’s operating leases is recognized on a straight-line basis over the lease term. The Company will evaluate the lease arrangement for impairment whenever events or changes in circumstances indicate that the carrying amounts of the right-of-use asset may not be fully recoverable. To the extent an impairment of the right-of-use asset is recognized, the Company will recognize lease impairment and subsequently amortize the remaining lease asset on a straight-line basis (unless another systematic basis is more representative of the pattern in which the Company expects to consume the future economic benefits from the asset) from the date of impairment to the earlier of the end of the right-of-use asset’s useful life or the end of the lease term. The Company has elected not to separate lease and non-lease components for its real estate and copier leases and, as a result, accounts for any lease and non-lease components as a single lease component. The Company has also elected not to apply the recognition requirement to any leases with a term of 12 months or less and does not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. Recently Adopted Accounting Pronouncements None. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents and marketable securities. Fair value is determined based on a three-tier hierarchy under the authoritative guidance for fair value measurements and disclosures that prioritizes the inputs used in measuring fair value as follows: Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurements and unobservable (i.e., supported by little or no market activity). The fair value measurements of the Company’s cash equivalents and marketable securities are identified at the following levels within the fair value hierarchy (in thousands): September 30, 2023 Fair Value Measurements Total Level 1 Level 2 Level 3 Assets: Cash equivalents: Money market funds $ 3,417 $ 3,417 $ — $ — Total 3,417 3,417 — — Marketable securities: U.S. government-sponsored entity debt securities 28,637 — 28,637 — Commercial paper securities 18,891 — 18,891 — Corporate debt securities 1,379 — 1,379 — Asset-backed securities 8,429 — 8,429 — U.S. treasury bills 5,581 — 5,581 — Certificates of deposit 12,680 — 12,680 — Total 75,597 — 75,597 — Total cash equivalents and marketable securities $ 79,014 $ 3,417 $ 75,597 $ — December 31, 2022 Fair Value Measurements Total Level 1 Level 2 Level 3 Assets: Cash equivalents: Money market funds $ 50,820 $ 50,820 $ — $ — Total 50,820 50,820 — — Marketable securities: U.S. government-sponsored entity debt securities 18,417 — 18,417 — Commercial paper securities 101,165 — 101,165 — Corporate debt securities 11,670 — 11,670 — Asset-backed securities 24,792 — 24,792 — U.S. treasury bills 7,938 — 7,938 — Certificates of deposit 37,461 — 37,461 — Agency bonds 5,590 — 5,590 — Total 207,033 — 207,033 — Total cash equivalents and marketable securities $ 257,853 $ 50,820 $ 207,033 $ — Cash Equivalents and Marketable Securities The Company generally classifies its marketable securities as Level 2. Instruments are classified as Level 2 when observable market prices for identical securities that are traded in less active markets are used. When observable market prices for identical securities are not available, such instruments are priced using benchmark curves, benchmarking of like securities, sector groupings, matrix pricing and valuation models. These valuation models are proprietary to the pricing providers or brokers and incorporate a number of inputs, including in approximate order of priority: benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data including market research publications. For certain security types, additional inputs may be used, or some of the standard inputs may not be applicable. Evaluators may prioritize inputs differently on any given day for any security based on market conditions, and not all inputs listed are available for use in the evaluation process for each security evaluation on any given day. |
CASH EQUIVALENTS AND MARKETABLE
CASH EQUIVALENTS AND MARKETABLE SECURITIES | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
CASH EQUIVALENTS AND MARKETABLE SECURITIES | CASH EQUIVALENTS AND MARKETABLE SECURITIES The table below summarizes the Company’s cash equivalents and marketable securities (in thousands): Amortized Gross Gross Estimated September 30, 2023 Assets Cash equivalents: Money market funds $ 3,417 $ — $ — $ 3,417 Total 3,417 — — 3,417 Marketable securities: U.S. government-sponsored entity debt securities 28,655 — (18) 28,637 Commercial paper securities 18,901 — (10) 18,891 Corporate debt securities 1,379 — — 1,379 Asset-backed securities 8,429 — — 8,429 U.S. treasury bills 5,599 — (18) 5,581 Certificates of deposit 12,684 1 (5) 12,680 Total 75,647 1 (51) 75,597 Total cash equivalents and marketable securities $ 79,064 $ 1 $ (51) $ 79,014 December 31, 2022 Assets Cash equivalents: Money market funds $ 50,820 $ — $ — $ 50,820 Total 50,820 — — 50,820 Marketable securities: U.S. government-sponsored entity debt securities 18,710 — (293) 18,417 Commercial paper securities 101,336 22 (193) 101,165 Corporate debt securities 11,760 — (90) 11,670 Asset-backed securities 24,970 2 (180) 24,792 U.S. treasury bills 7,950 — (12) 7,938 Certificates of deposit 37,599 4 (142) 37,461 Agency bonds 5,598 — (8) 5,590 Total 207,923 28 (918) 207,033 Total cash equivalents and marketable securities $ 258,743 $ 28 $ (918) $ 257,853 The fair value of marketable securities by contractual maturity were as follows (in thousands): September 30, December 31, Maturing in one year or less $ 41,173 $ 177,188 Maturing after one year through five years 34,424 29,845 Total $ 75,597 $ 207,033 There were no realized gains and losses on the sales of investments during the three and nine months ended September 30, 2023 and 2022. Total unrealized gains for securities with net gains in accumulated other comprehensive income were not material for the three and nine months ended September 30, 2023. The Company manages credit risk associated with its investment portfolio through its investment policy, which limits purchases to high-quality issuers and also limits the amount of its portfolio that can be invested in a single issuer. The Company did not record an allowance for credit losses related to its marketable securities for the three and nine months ended September 30, 2023 and 2022. The Company had unrealized losses related to its marketable securities for the three and nine months ended September 30, 2023 and 2022. The Company had no material unrealized losses, individually and in the aggregate, for marketable securities that are in a continuous unrealized loss position for greater than 12 months as of September 30, 2023 and December 31, 2022. These unrealized losses were not attributed to credit risk and were associated with changes in market conditions. The Company periodically reviews its marketable securities for indications of credit losses. The Company considers factors such as the duration, the magnitude and the reason for the decline in value, the potential recovery period, creditworthiness of the issuers of the securities and its intent to sell. No significant facts or circumstances have arisen to indicate that there has been any significant deterioration in the creditworthiness of the issuers of the securities held by the Company. Based on the Company’s review of these securities, the Company determined that no allowance for credit losses related to its marketable securities was required at either September 30, 2023 or December 31, 2022. The Company also considers whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis. Based on the scheduled maturities of its investments and projection of its cash flows in accordance with the current operating plan as of September 30, 2023, the Company determined that it was more likely than not that it will be required to sell various securities before recovery of their amortized cost basis. As a result, the Company reclassified its non-current marketable securities investments of $34.4 million as current as of September 30, 2023 and recorded an impairment charge of $0.4 million related to those securities during the three and nine ended September 30, 2023. No impairment charges were recorded during the three and nine ended September 30, 2022, as the Company concluded at that time it had the ability and intent to hold the long-term investments until maturity. |
BASIC AND DILUTED NET LOSS PER
BASIC AND DILUTED NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
BASIC AND DILUTED NET LOSS PER SHARE | BASIC AND DILUTED NET LOSS PER SHARE Basic net loss per share has been computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration of any potential dilutive securities, as their effect would be anti-dilutive. The total number of shares subject to stock options and restricted stock units (“RSUs”) outstanding and the employee stock purchase plan (“ESPP”) shares reserved for issuance, which are all anti-dilutive, were excluded from consideration in the calculation of diluted net loss per share attributable to Sangamo Therapeutics, Inc. stockholders. Stock options and RSUs outstanding and ESPP shares reserved for issuance as of September 30, 2023 and 2022 totaled 22,131,291 and 18,524,016, respectively. |
MAJOR CUSTOMERS, PARTNERSHIPS A
MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES | MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES Pfizer Inc. Giroctocogene Fitelparvovec Global Collaboration and License Agreement In May 2017, the Company entered into an exclusive global collaboration and license agreement with Pfizer Inc. (“Pfizer”), pursuant to which it established a collaboration for the research, development and commercialization of giroctocogene fitelparvovec, its gene therapy product candidate for hemophilia A, and closely related products. Under this agreement, the Company is responsible for conducting the Phase 1/2 clinical trial and for certain manufacturing activities for giroctocogene fitelparvovec, while Pfizer is responsible for subsequent worldwide development, manufacturing, marketing and commercialization of giroctocogene fitelparvovec. Sangamo may also collaborate in the research and development of additional adeno-associated viruses (“AAV”) -based gene therapy products for hemophilia A. Subject to the terms of the agreement, the Company granted Pfizer an exclusive worldwide royalty-bearing license, with the right to grant sublicenses, to use certain technology controlled by the Company for the purpose of developing, manufacturing and commercializing giroctocogene fitelparvovec and related products. Pfizer granted the Company a non-exclusive, worldwide, royalty-free, fully paid license, with the right to grant sublicenses, to use certain manufacturing technology developed under the agreement and controlled by Pfizer to manufacture the Company’s products that utilize the AAV delivery system. During a specified period, neither the Company nor Pfizer is permitted to clinically develop or commercialize, outside of the collaboration, certain AAV-based gene therapy products for hemophilia A. Unless earlier terminated, the agreement has a term that continues on a per product and per country basis until the later of (i) the expiration of patent claims that cover the product in a country, (ii) the expiration of regulatory exclusivity for a product in a country, and (iii) fifteen years after the first commercial sale of a product in a country. Pfizer has the right to terminate the agreement without cause in its entirety or on a per product or per country basis. The agreement may also be terminated by either party based on an uncured material breach by the other party or the bankruptcy of the other party. Upon termination for any reason, the license granted by the Company to Pfizer to develop, manufacture and commercialize giroctocogene fitelparvovec and related products will automatically terminate. Upon termination by the Company for cause or by Pfizer in any country or countries, Pfizer will automatically grant the Company an exclusive, royalty-bearing license under certain technology controlled by Pfizer to develop, manufacture and commercialize giroctocogene fitelparvovec in the terminated country or countries. Upon execution of the agreement, the Company received an upfront fee of $70.0 million and was eligible to receive up to $208.5 million in payments upon the achievement of specified clinical development, intellectual property and regulatory milestones and up to $266.5 million in payments upon first commercial sale milestones for giroctocogene fitelparvovec and potentially other products. To date, two milestones of $55.0 million in aggregate have been achieved and paid. The Company is eligible to earn from Pfizer up to $220.0 million in remaining milestone payments for giroctocogene fitelparvovec and up to $175.0 million for other products that may be developed under the agreement, subject to reduction on account of payments made under certain licenses for third-party intellectual property. In addition, Pfizer agreed to pay the Company royalties for each potential licensed product developed under the agreement that are 14% - 20% of the annual worldwide net sales of such product and are subject to reduction due to patent expiration, entry of biosimilar products to the market and payment made under certain licenses for third-party intellectual property. The Company assessed the agreement with Pfizer in accordance with ASC Topic 606 and concluded that Pfizer was a customer. The total transaction price under this agreement was $134.0 million, which represented the upfront fee and research services fees of $79.0 million and fees related to two achieved milestones in an aggregate amount of $55.0 million. Sangamo was responsible for internal and external research costs as part of the upfront fee and had the ability to request additional reimbursement from Pfizer if certain conditions were met. None of the constrained clinical or regulatory milestones were included in the transaction price. As part of its evaluation of the constraint, the Company considered numerous factors, including the fact that achievement of the milestones at the time was uncertain and contingent upon future periods when the uncertainty related to the variable consideration is resolved. The Company has identified the performance obligations within the agreement as a license to the technology and ongoing research services. The Company concluded that the license was not discrete as it did not have stand-alone value to Pfizer apart from the research services to be performed by the Company pursuant to the agreement. As a result, the Company recognized revenue from the upfront payment based on proportional performance of the ongoing research services through 2020, the period during which the Company performed research services. The estimation of progress towards the satisfaction of its performance obligation and project cost was reviewed quarterly and adjusted, as needed, to reflect the Company’s assumptions regarding the timing of its deliverables. In December 2020, the Company satisfied the deliverables and research services responsibilities within the arrangement. As a result, the Company recognized the remaining deferred revenue from the upfront payment in December 2020. C9ORF72 Research Collaboration and License Agreement In December 2017, the Company entered into a separate exclusive, global collaboration and license agreement with Pfizer for the development and commercialization of potential gene therapy products that use zinc finger (“ZF”) transcriptional regulators (“ZF-TRs”) to treat amyotrophic lateral sclerosis and frontotemporal lobar degeneration linked to mutations of the C9ORF72 gene. Pursuant to this agreement, the Company agreed to work with Pfizer on a research program to identify, characterize and preclinically develop ZF-TRs that bind to and specifically reduce expression of the mutant form of the C9ORF72 gene. Subject to the terms of this agreement, the Company granted Pfizer an exclusive, royalty-bearing, worldwide license under the Company’s relevant patents and know-how to develop, manufacture and commercialize gene therapy products that use resulting ZF-TRs that satisfy pre-agreed criteria. During a specified period, neither the Company nor Pfizer will be permitted to research, develop, manufacture or commercialize outside of the collaboration any zinc finger proteins (“ZFPs”) that specifically bind to the C9ORF72 gene. Unless earlier terminated, the agreement has a term that continues on a per licensed product and per country basis until the later of (i) the expiration of patent claims that cover the licensed product in a country, (ii) the expiration of regulatory exclusivity for a licensed product in a country, and (iii) 15 years after the first commercial sale of a licensed product in a major market country. Pfizer also has the right to terminate the agreement without cause in its entirety or on a per product or per country basis. The agreement may also be terminated by either party based on an uncured material breach by the other party or the bankruptcy of the other party. The agreement will also terminate if the Company is unable to identify any lead candidates for development within a specified period of time or if Pfizer elects not to advance a lead candidate beyond a certain development milestone within a specified period of time. Upon termination for any reason, the license granted by the Company to Pfizer to develop, manufacture and commercialize licensed products under the agreement will automatically terminate. Upon termination by the Company for cause or by Pfizer without cause for any licensed product or licensed products in any country or countries, the Company will have the right to negotiate with Pfizer to obtain a non-exclusive, royalty-bearing license under certain technology controlled by Pfizer to develop, manufacture and commercialize the licensed product or licensed products in the terminated country or countries. Following termination by the Company for Pfizer’s material breach, Pfizer will not be permitted to research, develop, manufacture or commercialize ZFPs that specifically bind to the C9ORF72 gene for a period of time. Following termination by Pfizer for the Company’s material breach, the Company will not be permitted to research, develop, manufacture or commercialize ZFPs that specifically bind to the C9ORF72 gene for a period of time. The Company received a $12.0 million upfront payment from Pfizer and is eligible to receive up to $60.0 million in development milestone payments from Pfizer contingent on the achievement of specified preclinical development, clinical development and first commercial sale milestones, and up to $90.0 million in commercial milestone payments if annual worldwide net sales of the licensed products reach specified levels. In addition, Pfizer will pay the Company royalties of 14% - 20% of the annual worldwide net sales of the licensed products. These royalty payments are subject to reduction due to patent expiration, entry of biosimilar products to the market and payments made under certain licenses for third-party intellectual property. Each party will be responsible for the cost of its performance of the research program. Pfizer will be operationally and financially responsible for subsequent development, manufacturing and commercialization of the licensed products. To date, a milestone of $5.0 million has been achieved and paid, however no products have been approved and therefore no royalty fees have been earned under the C9ORF72 Pfizer agreement. The Company assessed the agreement with Pfizer in accordance with ASC Topic 606 and concluded that Pfizer was a customer. The Company concluded the total transaction price under this agreement was $17.0 million, which represented the upfront fees of $12.0 million and fees related to achievement of one milestone in the amount of $5.0 million. None of the constrained clinical or regulatory milestones were included in the transaction price. As part of its evaluation of the constraint, the Company considered numerous factors, including the fact that achievement of the milestones at the time was uncertain and contingent upon future periods when the uncertainty related to the variable consideration is resolved. The Company had identified the performance obligations within this agreement as a license to the technology and ongoing research services. The Company concluded that the license is not discrete as it does not have stand-alone value to Pfizer apart from the services to be performed by the Company pursuant to the agreement. As a result, the Company recognized revenue from the upfront payment based on proportional performance of the ongoing research services through 2020, the period the Company performed research services. The Company satisfied the deliverables and research services responsibilities within the arrangement in September 2020, and as a result, earned a $5.0 million milestone, which the Company recognized on a cumulative basis during the year ended December 31, 2020. In addition, the Company recognized the remaining deferred revenue from the upfront payment in September 2020. In October 2023, Pfizer notified the Company of Pfizer’s assignment of the collaboration and license agreement to Alexion, AstraZeneca Rare Disease, pursuant to a definitive purchase and license agreement for preclinical gene therapy assets and enabling technologies that closed on September 20, 2023. Kite Pharma, Inc. In February 2018, the Company entered into a global collaboration and license agreement with Kite which became effective on April 5, 2018 (“Effective Date”), and was amended and restated in September 2019, for the research, development, and commercialization of potential engineered cell therapies for cancer. The collaboration and license agreement relates to the design of zinc finger nucleases (“ZFNs”) and viral vectors to disrupt and insert certain genes in T-cells and natural killer cells (“NK-cells”) including the insertion of genes that encode chimeric antigen receptors (“CARs”), T-cell receptors (“TCRs”), and NK-cell receptors (“NKRs”) directed to mutually agreed targets. Under the agreement, Kite is responsible for all clinical development, manufacturing and commercialization of any resulting products. Subject to the terms of this agreement, the Company granted Kite an exclusive, royalty-bearing, worldwide sublicensable license under the Company’s relevant patents and know-how to develop, manufacture and commercialize, for the purpose of treating cancer, specific cell therapy products that may result from the research program and that are engineered ex vivo using selected ZFNs and viral vectors developed under the research program to express CARs, TCRs or NKRs directed to candidate targets. Following the Effective Date, the Company received a $150.0 million upfront payment from Kite. In addition, Kite reimburses the Company’s direct costs to conduct the joint research program. Under the terms of the agreement, Sangamo is also eligible to receive contingent development- and sales-based milestone payments that could total up to $3.0 billion if all of the specified milestones set forth in this agreement are achieved. Of this amount, approximately $1.3 billion relates to the achievement of specified research, clinical development, regulatory and first commercial sale milestones, and approximately $1.8 billion relates to the achievement of specified sales-based milestones if annual worldwide net sales of licensed products reach specified levels. Each development- and sales-based milestone payment is payable (i) only once for each licensed product, regardless of the number of times that the associated milestone event is achieved by such licensed product, and (ii) only for the first 10 times that the associated milestone event is achieved regardless of the number of licensed products that may achieve such milestone event. In addition, the Company is entitled to receive escalating, tiered royalty payments with a percentage in the single digits based on future annual worldwide net sales of licensed products. These royalty payments are subject to reduction due to patent expiration, entry of biosimilar products to the market and payments made under certain licenses for third-party intellectual property. The initial research term in the agreement is six years from the Effective Date and will expire in April 2024. Kite has an option to extend the research term for up to two additional one-year periods for a separate upfront fee of $10.0 million per year. All contingent payments under the agreement, when earned, will be non-refundable and non-creditable. Through the amendment and restatement of the agreement in September 2019, the Company and Kite agreed to expand the scope of the collaboration program to incorporate the use of lentiviral or retroviral vectors provided by Kite. Kite has the right to terminate this agreement in its entirety or on a per licensed product or per candidate target basis for any reason after a specified notice period. Each party has the right to terminate this agreement on account of the other party’s bankruptcy or material, uncured breach. The Company assessed the agreement with Kite in accordance with ASC Topic 606 and concluded that Kite is a customer. The transaction price includes the upfront license fee of $150.0 million and estimated reimbursable service costs for the research projects over the estimated performance period. None of the clinical or regulatory milestones have been included in the transaction price, as none of the milestones have yet been achieved, and all amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including the fact that achievement of the milestones at this time is uncertain and contingent upon future periods when the uncertainty related to the variable consideration is resolved. The transaction price also includes actual and estimated payments by Kite for the work by Company researchers and reimbursement of the Company’s costs incurred with third parties. The Company uses the expected value method to estimate payments related to the Company’s researchers’ work, taking into account the impact of constraint. Variable consideration is included in the transaction price only to the extent it is probable a significant reversal of cumulative revenues recognized would not occur. The Company will re-evaluate 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 Company has identified four performance obligations within the Kite agreement as follows: (1) a license to the technology combined with the obligation to perform research and development services to apply the Company’s technology to Kite-selected targets; (2) production of research materials; and (3-4) two material rights, each for an extension of the research period for an additional one-year term. Such extensions contain material rights because their exercise does not require payment of a fee that is commensurate with the value of the incremental research term. The license to the Company’s intellectual property is not distinct from the related research and development activities as the licensed technology is not shared with and cannot be utilized by Kite without the research services performed by the Company. The Company allocated variable consideration (payments by Kite for the work performed by the Company’s researchers and third-party costs, as well as any future milestones and royalties) to the specific performance obligations to which they relate, as such allocation would meet the allocation objective in ASC Topic 606. The Company allocated the fixed consideration of $150.0 million to the performance obligations based on their relative standalone selling prices. Standalone selling prices of optional research years are similar to those of the initial year, but additionally take into account the intrinsic value of the discount upon exercise and the likelihood of exercise. Fees allocated to options with material rights are deferred until the options are exercised or expire. The exercise of options is accounted for as contract continuation, with target selection fees and estimated variable consideration included in the transaction price at that time and allocated specifically to the respective target’s performance obligation. Revenue for the combined license and research services performance obligations is recognized over time, as Kite consumes the benefit of such services as they are being performed by the Company. For the license combined with research and development services performance obligation, the Company recognizes revenue based on proportional performance of the ongoing research services over the period during which the Company performs the services. The estimation of progress towards the satisfaction of this performance obligation and project costs are reviewed quarterly and adjusted, as needed, to reflect the Company’s assumptions regarding the estimated volume of required activities. The production of research materials performance obligation is accounted for under the right to invoice practical expedient, as the Company has the right to invoice Kite for these services in an amount that corresponds directly with the value of the services. As of September 30, 2023 and December 31, 2022, the Company had a receivable of $0.2 million and $0.7 million, respectively, and deferred revenue of $1.5 million and $19.4 million, respectively, related to this agreement. Changes in deferred revenue balances during the three and nine months ended September 30, 2023 relate to a reduction in the estimated future level of the Company's research and development services under the collaboration agreement with Kite, as well as ongoing normal progress in the delivery of the performance obligations. The amounts of transaction price (excluding the amounts recognized as invoiced for the production of research materials performance obligation) remaining to be recognized were $1.5 million and $21.2 million, of which $1.5 million relates to fees allocated to options with material rights, as of September 30, 2023 and December 31, 2022, respectively. These amounts are expected to be recognized within the next 12 months. The timing of recognition will be affected by whether and when Kite exercises options for additional years of services and could be subject to significant changes. Revenues recognized under the agreement were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Revenue related to Kite agreement: Recognition of license fee fixed consideration $ 5,388 $ 6,296 $ 17,938 $ 18,682 Research services variable consideration 108 619 1,097 875 Total $ 5,496 $ 6,915 $ 19,035 $ 19,557 In March 2023, the Company recorded additional revenue related to a change in estimate in connection with the collaboration agreement with Kite Pharma, Inc. This adjustment was driven by a reduction in the estimated future level of the Company’s research and development services and as a result, future project costs. This resulted in an increase in proportional cumulative performance on this collaboration and an increase in revenue of $8.9 million, a decrease in net loss of $8.9 million, and a decrease in the Company’s basic and diluted net loss per share of $0.05 for the nine months ended September 30, 2023. In September 2023, the Company recorded additional revenue related to a change in estimate in connection with the collaboration agreement with Kite. This adjustment was driven by a further reduction in the estimated future level of the Company’s research and development services and as a result, future project costs. This resulted in an increase in proportional cumulative performance on this collaboration and increased revenue by $4.9 million, decreased net loss by $4.9 million, and decreased the Company's basic and diluted net loss per share by $0.03 for the three and nine months ended September 30, 2023. Novartis Institutes for BioMedical Research, Inc. On July 27, 2020, the Company entered into a collaboration and license agreement with Novartis Institutes for BioMedical Research, Inc. (“Novartis”) for the research, development and commercialization of gene regulation therapies to treat three neurodevelopmental disorders. Under the agreement, which was effective upon execution, the Company granted Novartis an exclusive, royalty bearing and worldwide license, under its relevant patents and know-how, to develop, manufacture and commercialize certain of its ZF-TRs targeted to three undisclosed genes that are associated with certain neurodevelopmental disorders, including autism spectrum disorder and intellectual disability. The Company was performing early research activities over the collaboration period for each gene target and manufacture the ZF-TRs required for such research, costs of which are funded by Novartis. Novartis was responsible for additional research activities, studies enabling INDs, clinical development, regulatory approvals, manufacturing of preclinical, clinical and approved products, and global commercialization. Subject to certain exceptions set forth in the agreement, the Company was prohibited from developing, manufacturing or commercializing any therapeutic product targeting any of the three genes that are the subject of the collaboration. Novartis also had the option to license certain of the Company’s proprietary AAVs for the sole purpose of developing, manufacturing and commercializing licensed products arising from the collaboration. In March 2023, Novartis notified the Company of its termination for convenience, effective June 11, 2023 (the “Novartis Termination Date”), of the collaboration agreement. Novartis had indicated to the Company that the termination relates to a recent strategic review. As of the Novartis Termination Date, the collaboration agreement was terminated in its entirety and following the Novartis Termination Date the Company is not entitled to receive any further milestone payments or royalties from Novartis. As of the Novartis Termination Date, the parties have no further obligations to develop or to fund the development of any collaboration research programs under the collaboration agreement. Upon entering the agreement, Novartis paid the Company a $75.0 million upfront license fee. Novartis was also obligated to pay the Company for the use of its resources and reimburse third-party costs incurred in the Company’s conduct of early research activities. The Company was also eligible to earn from Novartis development and commercial milestones and royalties on potential commercial sales of licensed products arising from the collaboration, none of which were triggered or earned. The agreement was going to continue, on a product-by-product and country-by-country basis, until the expiration of the applicable royalty term. All payments received under the agreement were non-refundable and non-creditable. The transaction price of $95.1 million included the upfront license fee of $75.0 million and research costs of $20.1 million. All clinical or regulatory milestone amounts were considered fully constrained throughout the term of the agreement. The Company assessed the agreement with Novartis in accordance with ASC Topic 606 and concluded that Novartis was a customer. The Company had identified a single performance obligation within this arrangement as a license to the technology and ongoing research services. The Company concluded that the license was not discrete as it did not have stand-alone value to Novartis apart from the research services to be performed pursuant to the agreement. As a result, the Company recognized revenue from the upfront payment based on proportional performance of the ongoing research services through the estimated research period. The estimation of progress towards the satisfaction of performance obligation and project cost was reviewed quarterly and adjusted, as needed, to reflect the Company’s current assumptions regarding the timing of its performance obligation. The notice of termination was accounted for as a modification of the contract, as it changed both the scope of the Company’s remaining services and the consideration to which the Company was entitled. The effect of the modification was not material, as the Company was nearing the completion of its assigned early research activities, and consequently, of its sole performance obligation. As of September 30, 2023 and December 31, 2022, the Company had a receivable of zero and $2.2 million, respectively, and deferred revenue of zero and $9.6 million, respectively, related to this agreement. Revenues recognized under the agreement were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Revenue related to Novartis agreement: Recognition of upfront license fee $ — $ 7,582 $ 9,568 $ 23,222 Research services — 2,028 2,611 6,211 Total $ — $ 9,610 $ 12,179 $ 29,433 Biogen MA, Inc. In February 2020, the Company entered into a collaboration and license agreement with Biogen MA, Inc. (“BIMA”) and Biogen International GmbH (together with BIMA, “Biogen”) for the research, development and commercialization of gene regulation therapies for the treatment of neurological diseases. The companies planned to leverage the Company’s proprietary ZF technology delivered via AAV to modulate expression of key genes involved in neurological diseases. Concurrently with the execution of the collaboration agreement, the Company entered into a stock purchase agreement with BIMA, pursuant to which BIMA agreed to purchase 24,420,157 shares of the Company’s common stock (the “Biogen Shares”), at a price per share of $9.2137, for an aggregate purchase price of approximately $225.0 million. The collaboration agreement became effective in April 2020. In March 2023, Biogen notified the Company of its termination for convenience, effective June 15, 2023 (the “Biogen Termination Date”), of the collaboration agreement. Biogen had indicated to the Company that the termination relates to a recent strategic review. As of the Biogen Termination Date, the collaboration agreement was terminated in its entirety and following the Biogen Termination Date the Company is not entitled to receive any further milestone payments or royalties from Biogen. As of the Biogen Termination Date, the parties have no further obligations to develop or to fund the development of any collaboration research programs under the collaboration agreement. Under the collaboration agreement, Biogen paid the Company an upfront license fee of $125.0 million in May 2020. The Company was also eligible to receive target selection, research, development, regulatory and commercial milestone payments and royalties on potential net commercial sales of licensed products arising from the collaboration, none of which were triggered or earned. Under the collaboration agreement, the Company granted to Biogen an exclusive, royalty bearing and worldwide license, under its relevant patents and know-how, to develop, manufacture and commercialize ZF and/or AAV-based products directed to certain neurological disease gene targets selected by Biogen. Biogen had selected four targets over the course of the collaboration and had exclusive rights to nominate up to seven additional targets. These rights expired upon the Biogen Termination Date. For each gene target selected by Biogen, the Company performed early research activities, costs of which were shared by the companies, aimed at the development of the combination of proprietary central nervous system delivery vectors and ZF-TRs (or potential other ZF products) targeting therapeutically relevant genes. The Company assessed the collaboration agreement with Biogen in accordance with ASC Topic 606 and concluded that Biogen is a customer. The transaction price included the upfront license fee of $125.0 million and the excess consideration from the stock purchase of $79.6 million, which represented the difference between the $225.0 million received for the purchase of the Biogen Shares and the $145.4 million estimated fair value of the equity issued. The equity issued to Biogen was valued using an option pricing model to reflect certain holding period restrictions. None of the clinical or regulatory milestones were included in the transaction price, as all such amounts were fully constrained throughout the term of the collaboration agreement. The transaction price also included actual and estimated cost-sharing payments by Biogen for the work by Company researchers and reimbursement of the Company’s costs incurred with third parties. The amounts paid and expected to be paid to Biogen for the use of Biogen’s resources and its expenses were consideration paid to a customer. Since the Company did not acquire distinct goods or services in exchange for these payments, they reduced the transaction price and were recorded as a reduction in revenue. The Company used the expected value method to estimate cost sharing payments, taking into account the impact of the constraint. Variable consideration was included in the transaction price only to the extent it was probable a significant reversal of cumulative revenues recognized would not occur. The Company re-evaluated the transaction price as uncertain events were resolved or other changes in circumstances occurred. The Company concluded that the licenses to its intellectual property for each target were not distinct from the related research and development activities, as the licensed technology was not shared with and could not be utilized by Biogen without the research services to be performed by the C |
IMPAIRMENT OF GOODWILL, INDEFIN
IMPAIRMENT OF GOODWILL, INDEFINITE-LIVED INTANGIBLE ASSETS AND OTHER LONG-LIVED ASSETS | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
IMPAIRMENT OF GOODWILL, INDEFINITE-LIVED INTANGIBLE ASSETS AND OTHER LONG-LIVED ASSETS | IMPAIRMENT OF GOODWILL, INDEFINITE-LIVED INTANGIBLE ASSETS AND OTHER LONG-LIVED ASSETS Three months ended March 31, 2023 During the three months ended March 31, 2023, as a result of the sustained decline in the Company’s stock price and related market capitalization, termination of the collaboration agreements with Biogen and Novartis, and a general decline in equity values in the biotechnology industry, the Company performed an impairment assessment of goodwill, indefinite-lived intangible assets, and long-lived assets. The Company operates as a single reporting unit based on its business and reporting structure. For goodwill, a quantitative impairment assessment was performed using a market approach, whereby the Company’s fair value of equity was compared to its carrying value. The fair value of equity was derived using both the market capitalization of the Company and an estimate of a reasonable range of values of a control premium applied to the Company’s implied business enterprise value. The control premium was estimated based upon control premiums observed in comparable market transactions. This represents a level 2 nonrecurring fair value measurement. Based on this analysis, the Company recognized a pre-tax goodwill impairment charge of $38.1 million during the three months ended March 31, 2023. As a result, the goodwill was fully impaired as of March 31, 2023. Before completing the goodwill impairment assessment, the Company also tested its indefinite-lived intangible assets and then its long-lived assets for impairment. Based on the qualitative assessment, the Company determined it was more likely than not that its indefinite-lived intangible assets were not impaired. The Company determined all of its long-lived assets represent one asset group for purposes of long-lived asset impairment assessment. The Company concluded that the carrying value of the asset group was not recoverable as it exceeded the future undiscounted cash flows the assets are expected to generate from the use and eventual disposition. To allocate and recognize the impairment loss, the Company determined individual fair values of its long-lived assets. The Company applied a discounted cash flow method to estimate fair values of its leasehold improvements and right-of-use assets, including leasehold improvements in the process of construction and a cost replacement method to estimate the fair value of its furniture, fixtures and laboratory and manufacturing equipment. These represented level 3 nonrecurring fair value measurements. Based on this analysis, the Company recognized pre-tax long-lived asset impairment charges of $11.2 million on the right-of-use assets, $5.0 million on the related leasehold improvements, and $4.2 million on construction-in-progress, during the three months ended March 31, 2023. No impairment was recognized on the remaining long-lived assets as their carrying values were not in excess of their fair values. Three months ended June 30, 2023 During the three months ended June 30, 2023, the Company’s stock price and the related market capitalization continued to decline. In April 2023, the Company announced a restructuring of operations and a corresponding reduction in force, see Note 9 – Restructuring Charges . The Company also initiated discussions around several actions aimed at reducing costs, preserving liquidity and improving operational performance metrics. These actions include but are not limited to deferral and reprioritization of certain research and development programs, further reduction in force, and closing or downsizing its facilities. The Company reassessed its indefinite-lived and long-lived assets for impairment as of June 30, 2023. Given the actions contemplated above, the Company determined that it was more likely than not that its indefinite-lived intangible assets were impaired. Accordingly, the Company developed an estimate of the fair value of its indefinite-lived intangible assets using the multi-period excess earnings model (income approach) and concluded the carrying value of its indefinite-lived intangible assets were fully impaired. This represents a level 3 nonrecurring fair value measurement. As a result, an indefinite-lived intangible assets impairment charge of $51.3 million, as well as the related income tax benefit of $6.3 million due to the reversal of a deferred tax liability associated with the indefinite-lived intangible assets was recognized during the three months ended June 30, 2023. The impairment charge was primarily driven by a higher discount rate applied to future cash flows based on market participants’ view of increased risk related to the asset. The Company determined that there were indicators of impairment in its long-lived asset group as of June 30, 2023, based on the same factors above as well as the impairment of its indefinite-lived intangible assets. As the estimated fair value of this asset group, based on a market approach, exceeded its carrying value, no impairment loss was recognized. This represented a level 3 nonrecurring fair value measurement. Three months ended September 30, 2023 During the three months ended September 30, 2023, the Company’s stock price and the related market capitalization continued to decline, and as such, the Company reassessed its long-lived assets for impairment as of September 30, 2023. The Company determined all of its long-lived assets continued to represent one asset group for purposes of long-lived asset impairment assessment. The Company concluded that the carrying value of the asset group was not recoverable and the estimated fair value of this asset group was below its carrying value. The lower fair value of the asset group was mainly driven by the sustained decline in the Company's stock price and the related market capitalization. To recognize the impairment loss, the Company determined individual fair values of its long-lived assets. The Company applied a discounted cash flow method to estimate fair values of its leasehold improvements and right-of-use assets, including leasehold improvements in the process of construction, and a market approach to estimate the fair value of its furniture, fixtures and laboratory and manufacturing equipment. These represented level 3 nonrecurring fair value measurements. Based on this analysis, the Company concluded the fair values of the long-lived assets were lower than their net book values due to declines in the market prices for leases, furniture, fixtures, and equipment. The Company recognized pre-tax long-lived asset impairment charges of $17.6 million on the right-of-use assets, $13.7 million on the related leasehold improvements and construction-in-progress, and $13.5 million on furniture, fixtures, and laboratory and manufacturing equipment during the three months ended September 30, 2023. The Company will continue to assess whether its long-lived assets are impaired in future periods. As the Company finalizes and implements its plans related to cost reductions and liquidity preservation, it is reasonably possible that additional impairment charges will be recognized if the Company changes how it uses various long-lived assets or elects to dispose of them, and the cash flows associated with these assets become separately identifiable. In this case, such assets will be tested for impairment separately from the remaining long-lived assets of the Company. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION The following table shows total stock-based compensation expense recognized in the accompanying Condensed Consolidated Statements of Operations (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 3,236 $ 4,395 $ 11,996 $ 13,656 General and administrative 2,953 3,398 9,260 9,746 Total stock-based compensation expense $ 6,189 $ 7,793 $ 21,256 $ 23,402 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
STOCKHOLDERS' EQUITY | STOCKHOLDERS’ EQUITYAt-the-Market Offering AgreementIn August 2020, the Company entered into an Open Market Sale Agreement℠ with Jefferies LLC (“Jefferies”) with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of the Company’s common stock having an aggregate offering price of up to $150.0 million through Jefferies as the Company’s sales agent or principal. In December 2022, the Company entered into Amendment No. 2 to the Open Market Sale Agreement℠ which increased the aggregate offering price under the at-the-market offering program by an additional $175.0 million. The Company is not obligated to sell any shares under the sales agreement. No shares were sold under the sales agreement during the three months ended September 30, 2023. During the nine months ended September 30, 2023, the Company sold 8,249,261 shares of its common stock for net proceeds of approximately $15.1 million. During the three and nine months ended September 30, 2022, the Company sold 8,483,104 and 14,711,770 shares of its common stock for net proceeds of approximately $42.2 million and $66.4 million, respectively |
RESTRUCTURING CHARGES
RESTRUCTURING CHARGES | 9 Months Ended |
Sep. 30, 2023 | |
Restructuring and Related Activities [Abstract] | |
RESTRUCTURING CHARGES | RESTRUCTURING CHARGESOn April 26, 2023, the Company executed a restructuring of operations and a corresponding reduction in workforce (the “April Restructuring”), designed to reduce costs and increase focus on certain strategic priorities. The April Restructuring resulted in the elimination of approximately 110 roles, including 55 full-time employees and 55 contracted employees and eliminated open positions, in the United States, or approximately 23% of the total United States workforce as of April 26, 2023, and included one-time severance payments and other employee-related costs, including additional vesting of service-based stock compensation awards. No expenses related to the April Restructuring were incurred during the three months ended September 30, 2023. The Company incurred approximately $5.3 million of expenses related to the April Restructuring in the nine months ended September 30, 2023, of which $4.1 million is included in research and development expense and $1.2 million is included in general and administrative expense in the accompanying Condensed Consolidated Statements of Operations. The Company expects the April Restructuring and the cash payments related to the April Restructuring to be complete by the third quarter of 2024. The following table is a summary of accrued April Restructuring costs included within other accrued liabilities on the Company’s Condensed Consolidated Balance Sheet as of September 30, 2023 (in thousands): Nine Months Ended September 30, 2023 Balance at December 31, 2022 $ — Restructuring charges 5,337 Cash payments (3,033) Non-cash adjustments (305) Balance at September 30, 2023 $ 1,999 |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES The Company’s provision for income taxes for interim periods is determined using an estimate of its annual effective tax rate, adjusted for discrete items, if any, that arise during the period. Each quarter, the Company updates its estimate of the annual effective tax rate, and if the estimated annual effective tax rate changes, the Company makes a cumulative adjustment in such period. During the three months ended September 30, 2023 and 2022 the Company recorded an income tax expense of $1.3 million and $0.1 million, respectively. During the nine months ended September 30, 2023 and 2022, the Company recorded income tax benefit of $4.8 million and income tax expense of $0.2 million, respectively. The Company continues to maintain a full valuation allowance on its U.S. federal and state, Sangamo France, and Sangamo United Kingdom net deferred tax assets, as the Company believes it is not more likely than not that these benefits will be realized. The net tax benefit for the nine months ended September 30, 2023 was primarily related to the impairment of the IPR&D asset, which was offset by the reduction of its United Kingdom’s deferred tax asset. The tax expense for the nine months ended September 30, 2022 was primarily due to foreign income tax expense. On August 16, 2022, the Inflation Reduction Act of 2022 was signed into law, and became effective in 2023, with tax provisions primarily focused on implementing a 15% minimum tax on global adjusted financial statement income and a 1% excise tax on share repurchases. The Company has evaluated the provisions of the tax law and noted that the law change would not have a material impact on the Condensed Consolidated Financial Statements. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS November Restructuring On October 11, 2023, the Board of Directors of the Company approved a restructuring of operations and a corresponding reduction in workforce (the “November Restructuring”), designed to reduce costs and advance its strategic transformation into a neurology-focused genomic medicine company. The Company notified employees affected by the November Restructuring on November 1, 2023. The Company expects the November Restructuring to result in the elimination of approximately 162 roles in the United States, or approximately 40% of its United States workforce. The Company estimates that it will incur approximately $8 million to $10 million in cash-based expenses related to employee severance and notice period payments, benefits and related restructuring costs. The Company expects that the majority of the restructuring charges will be incurred in the fourth quarter of 2023 and that the execution of the November Restructuring will be substantially complete by the second quarter of 2024. The Company may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the November Restructuring. Departure of Certain Officers In connection with the November Restructuring, the employment of each of D. Mark McClung, Executive Vice President, Chief Operating Officer, and Jason Fontenot, Ph.D., Senior Vice President, Chief Scientific Officer, will terminate, effective as of January 2, 2024. In connection with the termination of their employment, pursuant to the Amended Severance Plan (as defined below), Mr. McClung and Dr. Fontenot are entitled to certain severance benefits in exchange for the execution of a general settlement and release agreement. Approval of Amended and Restated Executive Severance Plan On October 28, 2023, the Compensation Committee of the Board of Directors of the Company approved an amendment and restatement of the Company’s Amended and Restated Executive Severance Plan (as so amended and restated, the “Amended Severance Plan”). The purpose of such amendment and restatement is to provide for the payment of certain severance benefits in the form of a lump sum (instead of in installments or monthly reimbursements) following termination. Specifically, if an Eligible Employee (as defined in the Amended Severance Plan and which includes all of the Company’s executive officers) becomes entitled to severance benefits under the Amended Severance Plan, (i) cash severance payments will be made in the form of a lump sum within 60 days following the Eligible Employee’s termination (instead of in the form of installments over the applicable severance period, which may range from 9 to 18 months following such termination depending on the Eligible Employee’s position) and (ii) cash payments intended to replace COBRA premium reimbursements may be made in the form of a lump sum within 60 days following the Eligible Employee’s termination (instead of in the form of monthly reimbursements over the applicable severance period), in the Company’s discretion, in each case to the extent that such payments (a) are exempt from Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), as determined by the Company in its discretion at the time of the Eligible Employee’s termination, or (ii) may otherwise be made in a lump sum upon such termination without causing adverse tax consequences under Section 409A of the Code. The changes regarding the timing and form of payment of certain severance benefits under the Amended Severance Plan, as described above, were the only material changes made under the Amended Severance Plan. No other material changes (including changes regarding eligibility for, or the amount or type of, severance benefits) were made under the Amended Severance Plan. Change of Company Headquarters On November 1, 2023, the Company announced that it expects to close its Brisbane, California facility in early 2024 to conserve cash resources, and intends to transition Company headquarters to its Richmond, California facility as of January 1, 2024. The Company may incur charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the closure of its Brisbane, California facility and the transition of company headquarters to its Richmond, California facility. Nasdaq Deficiency Notice |
ORGANIZATION, BASIS OF PRESEN_2
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of these financial statements for the periods presented have been included. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. The Condensed Consolidated Balance Sheet data at December 31, 2022 was derived from the audited Consolidated Financial Statements included in Sangamo’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Annual Report”) as filed with the SEC on February 23, 2023. |
Consolidation | The accompanying Condensed Consolidated Financial Statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated in the Condensed Consolidated Financial Statements. |
Use of Estimates | Use of Estimates The preparation of Condensed Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the Condensed Consolidated Financial Statements and the accompanying notes. On an ongoing basis, management evaluates its estimates including critical accounting policies or estimates related to revenue recognition, clinical trial accruals, income taxes, fair value of assets and liabilities, including from acquisitions, useful lives and impairment of long-lived assets, and stock-based compensation. Estimates are based on historical experience and on various other market specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. |
Revenue Recognition | Revenue Recognition The Company accounts for its revenues pursuant to the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”). The Company’s contract revenues are derived from collaboration agreements including licensing arrangements and research services. Research and licensing agreements typically include nonrefundable upfront signing or license fees, payments at negotiated rates for time incurred by Company researchers, third-party cost reimbursements, additional target selection fees, sublicense fees, milestone payments tied to ongoing development and product commercialization, and royalties on future licensees’ product sales. All funds received from the Company’s collaboration partners are generally not refundable. Non-refundable upfront fees are fixed at the commencement of the contract. All other fees represent variable consideration in contracts. One of the Company’s contracts also contains a provision where the Company reimburses its customer for certain costs they incur which is accounted for as a reduction to the contract transaction price as the Company does not acquire any distinct goods or services in exchange for such payments. Deferred revenue primarily represents the portion of nonrefundable upfront fees or milestone payments received but not earned. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Most of the Company’s performance obligations in its collaboration agreements represent distinct bundles of licenses of intellectual property and research and development services, with these components being individually non-distinct. Options to license the Company’s intellectual property and/or acquire research and development services also represent performance obligations when they grant customers a material right, e.g., a right to a discount the customer would not have received if they did not purchase the Company’s services under the existing contract. Revenues from bundles of licenses of intellectual property and research and development services are recognized over time using a proportional performance method. Under this method, revenue is recognized by measuring progress towards satisfaction of the relevant performance obligation using a measure that best depicts the progress towards satisfaction of the relevant performance obligation. For most of the Company’s agreements the measure of progress is an input measure based on a level of effort incurred, which includes the value of actual time by Company researchers plus third-party cost reimbursements. Consideration allocated to options that include material rights is deferred until the options are exercised or expire. The exercise of such options is accounted for as contract continuation, with target selection fees and estimated variable consideration included in the transaction price at that time and allocated specifically to the respective target’s performance obligation. Significant management judgment is required to determine the level of effort required under an arrangement, and the period over which the Company expects to complete its performance obligations under the arrangement. Changes in these estimates can have a material effect on revenue recognized. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. For variable consideration, the amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. A cumulative catch-up is then recorded in the current period to reflect the updated transaction price and the updated measure of progress. The estimated period of performance and level of effort, including the value of Company researchers’ time and third-party costs, are reviewed quarterly and adjusted, as needed, to reflect the Company’s current expectations. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, discount rates and probabilities of exercise of technical and regulatory success, and the expected level of effort for research and development services. Contract modifications occur when the price and/or scope of an arrangement changes. If the modification consists of adding new distinct goods or services in exchange for consideration that reflects standalone selling prices of these goods and services, the modification is accounted for as a separate contract with the customer. Otherwise, if the remaining goods and services are distinct from those previously provided, the existing contract is considered terminated, and the remaining consideration is allocated to the remaining goods and services as if this was a newly signed contract. If the remaining goods and services are not distinct from those previously provided, the effects of the modification are accounted for in a manner similar to the effect of a change in the estimated measure of progress, with cumulative catch-up in revenue recorded at the time of the modification. If some of the remaining goods and services are distinct from those previously provided and others are not, to account for the effects of the modification the Company applies principles consistent with the objectives of the modification accounting. Revenues from collaboration and licensing agreements as a percentage of total revenues were as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Kite Pharma, Inc. 58 % 26 % 11 % 23 % Biogen MA, Inc. 4 % 36 % 77 % 36 % Novartis Institutes for BioMedical Research, Inc. — % 36 % 7 % 35 % Other licensing agreements 38 % 2 % 5 % 6 % |
Impairment of Goodwill, Indefinite-lived Intangible Assets and Long-lived Assets | Impairment of Goodwill, Indefinite-lived Intangible Assets and Long-lived Assets Goodwill represents the excess of consideration transferred over the fair values of assets acquired and liabilities assumed in a business combination. Intangible assets with indefinite useful lives are related to acquired in-process research and development (“IPR&D”) projects and are initially measured at their respective fair values as of the acquisition date. Goodwill and indefinite-lived intangible assets are not amortized. Intangible assets related to IPR&D projects are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point in time. Goodwill and indefinite-lived intangible assets are assessed for impairment on an annual basis and whenever events and circumstances indicate that these assets may be impaired. The Company evaluates the carrying value of long-lived assets, which include property and equipment, leasehold improvements and right-of-use assets, for impairment whenever events or changes in circumstances indicate that the carrying amounts of the asset may not be fully recoverable. In testing for goodwill impairment, the Company has the option of first performing a qualitative assessment to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If the Company elects to bypass the qualitative assessment, or if a qualitative assessment indicates it is more likely than not that the carrying value exceeds its fair value, the Company performs a quantitative goodwill impairment test to compare the fair value of its reporting unit to its carrying value, including goodwill. If the carrying value, including goodwill, exceeds the reporting unit’s fair value, the Company will recognize an impairment loss for the amount by which the carrying amount exceeds the reporting unit’s fair value (but not in excess of the carrying value of goodwill). In performing each annual impairment assessment and any interim impairment assessment for its indefinite-lived intangible assets, the Company determines if it should qualitatively assess whether it is more likely than not the fair value of its IPR&D asset is less than its carrying amount (the qualitative impairment test). If the Company concludes that is the case, or elects not to use the qualitative impairment test, the Company will proceed with quantitatively determining the fair value of the IPR&D asset and comparing its fair value to its carrying value to determine the amount of impairment, if any (the quantitative impairment test). In performing the qualitative impairment test, the Company considers the results of the most recent quantitative impairment test and identifies the most relevant drivers of the fair value for the IPR&D asset. The most relevant drivers of fair value identified are consistent with the assumptions used in the quantitative estimate of the IPR&D asset. Using these drivers of fair value, the Company identifies events and circumstances which may have an effect on the fair value of the IPR&D asset since the last time the IPR&D’s fair value was quantitatively determined. The Company then weighs these factors to determine and conclude if it is not more likely than not the IPR&D asset is impaired. If it is more likely than not the IPR&D asset is impaired, the Company proceeds with quantitatively determining the fair value of the IPR&D asset. When performing the quantitative impairment test, the Company uses the income approach to determine the fair value of its IPR&D asset. This approach calculates fair value by estimating the after-tax cash flows attributable to an in-process project over its useful life and then discounting these after-tax cash flows back to a present value. This estimate includes judgmental assumptions regarding the estimates that market participants would make in evaluating the IPR&D asset, including the probability of successfully completing clinical trials and obtaining regulatory approval to market the IPR&D asset, the timing of and the expected costs to complete IPR&D projects, future net cash flows from potential drug sales, which are based on estimates of the sales price of the drug, the size of the patient population and cure rate, its competitive position in the marketplace, and appropriate discount and tax rates. Any impairment to be recorded is calculated as the difference between the estimated fair value and the carrying value of the IPR&D asset on the Company’s Condensed Consolidated Balance Sheet. If a change in circumstance occurs that indicates long-lived assets may be impaired, the Company performs a test of recoverability by comparing the carrying value of the asset or asset group to its undiscounted expected future cash flows. The long-lived asset evaluation is performed at the asset group level, i.e., the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities. If this review indicates that the carrying amount of the asset group is not recoverable, an impairment loss is measured as the amount by which the carrying amount of an asset group exceeds its fair value. Any impairment loss is allocated to the long-lived assets of the group on a pro rata basis using the relative carrying amounts of those assets, except that the carrying amount of an individual asset shall not be reduced below its fair value. Factors that may indicate potential impairment and trigger an impairment test include, but are not limited to, general macroeconomic conditions, conditions specific to the industry and market, an adverse change in legal factors, impairment of goodwill or indefinite-lived intangible assets, business climate or operational performance of the business, and sustained decline in the stock price and market capitalization compared to the net book value. Calculating the fair value of a reporting unit, an asset group and an individual asset involves significant estimates and assumptions. These estimates and assumptions include, among others, projected future cash flows, risk-adjusted discount rates, future economic and market conditions, and the determination of appropriate market comparables. Changes in these factors and assumptions used can materially affect the amount of impairment loss recognized in the period the asset was considered impaired. |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash Sangamo considers all highly liquid investments purchased with original maturities of three months or less at the purchase date to be cash equivalents. Cash and cash equivalents consist of cash, deposits in demand money market accounts and U.S. government-sponsored entity debt securities. Restricted cash consists of a letter of credit for $1.5 million, representing a deposit for the lease of the corporate headquarters in Brisbane, California. |
Marketable Securities | Marketable Securities Sangamo classifies its marketable securities as available-for-sale and records its investments at estimated fair value based on quoted market prices or observable market inputs of almost identical assets, with the unrealized holding gains and losses included in accumulated other comprehensive income (loss) (“AOCI”). The Company classifies those investments that are not required for use in current operations and that mature in more than 12 months as non-current marketable securities in the accompanying Condensed Consolidated Balance Sheets. The Company’s investments are subject to a periodic impairment review. The Company considers various factors in determining whether to recognize an impairment charge, including the length of time and extent to which the fair value has been less than the cost basis, the Company's financial condition and its intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. Realized gains and losses on marketable securities are included in interest and other income, net, which are determined using the specific identification method. Credit losses related to the marketable securities are recorded in interest and other income, net in the Condensed Consolidated Statements of Operations through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. |
Leases | Leases The Company determines if an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether it has the right to control the identified asset. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. Right-of-use assets are based on the measurement of the lease liability and also include any lease payments made prior to or on lease commencement and exclude lease incentives and initial direct costs incurred, as applicable. As the implicit rate in the Company’s leases is generally unknown, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of remaining lease payments. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease in a similar economic environment. The Company considers its credit risk, term of the lease, and total lease payments and adjusts for the impacts of collateral, as necessary, when calculating its incremental borrowing rates. The lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise any such options. Rent expense for the Company’s operating leases is recognized on a straight-line basis over the lease term. The Company will evaluate the lease arrangement for impairment whenever events or changes in circumstances indicate that the carrying amounts of the right-of-use asset may not be fully recoverable. To the extent an impairment of the right-of-use asset is recognized, the Company will recognize lease impairment and subsequently amortize the remaining lease asset on a straight-line basis (unless another systematic basis is more representative of the pattern in which the Company expects to consume the future economic benefits from the asset) from the date of impairment to the earlier of the end of the right-of-use asset’s useful life or the end of the lease term. The Company has elected not to separate lease and non-lease components for its real estate and copier leases and, as a result, accounts for any lease and non-lease components as a single lease component. The Company has also elected not to apply the recognition requirement to any leases with a term of 12 months or less and does not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements None. |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents and marketable securities. Fair value is determined based on a three-tier hierarchy under the authoritative guidance for fair value measurements and disclosures that prioritizes the inputs used in measuring fair value as follows: Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurements and unobservable (i.e., supported by little or no market activity). |
ORGANIZATION, BASIS OF PRESEN_3
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Revenue from Strategic Partnering Collaboration Agreements and Research Activity Grants as a Percentage of Total Revenues | Revenues from collaboration and licensing agreements as a percentage of total revenues were as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Kite Pharma, Inc. 58 % 26 % 11 % 23 % Biogen MA, Inc. 4 % 36 % 77 % 36 % Novartis Institutes for BioMedical Research, Inc. — % 36 % 7 % 35 % Other licensing agreements 38 % 2 % 5 % 6 % |
Schedule of Cash and Cash Equivalents | A reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets to the amounts reported within the accompanying Condensed Consolidated Statements of Cash Flows is as follows (in thousands): September 30, December 31, September 30, December 31, Cash and cash equivalents $ 56,514 $ 100,444 $ 94,570 $ 178,872 Non-current restricted cash 1,500 1,500 1,500 1,500 Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows $ 58,014 $ 101,944 $ 96,070 $ 180,372 |
Restrictions on Cash and Cash Equivalents | A reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets to the amounts reported within the accompanying Condensed Consolidated Statements of Cash Flows is as follows (in thousands): September 30, December 31, September 30, December 31, Cash and cash equivalents $ 56,514 $ 100,444 $ 94,570 $ 178,872 Non-current restricted cash 1,500 1,500 1,500 1,500 Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows $ 58,014 $ 101,944 $ 96,070 $ 180,372 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value Measurements of Cash Equivalents and Marketable Securities | The fair value measurements of the Company’s cash equivalents and marketable securities are identified at the following levels within the fair value hierarchy (in thousands): September 30, 2023 Fair Value Measurements Total Level 1 Level 2 Level 3 Assets: Cash equivalents: Money market funds $ 3,417 $ 3,417 $ — $ — Total 3,417 3,417 — — Marketable securities: U.S. government-sponsored entity debt securities 28,637 — 28,637 — Commercial paper securities 18,891 — 18,891 — Corporate debt securities 1,379 — 1,379 — Asset-backed securities 8,429 — 8,429 — U.S. treasury bills 5,581 — 5,581 — Certificates of deposit 12,680 — 12,680 — Total 75,597 — 75,597 — Total cash equivalents and marketable securities $ 79,014 $ 3,417 $ 75,597 $ — December 31, 2022 Fair Value Measurements Total Level 1 Level 2 Level 3 Assets: Cash equivalents: Money market funds $ 50,820 $ 50,820 $ — $ — Total 50,820 50,820 — — Marketable securities: U.S. government-sponsored entity debt securities 18,417 — 18,417 — Commercial paper securities 101,165 — 101,165 — Corporate debt securities 11,670 — 11,670 — Asset-backed securities 24,792 — 24,792 — U.S. treasury bills 7,938 — 7,938 — Certificates of deposit 37,461 — 37,461 — Agency bonds 5,590 — 5,590 — Total 207,033 — 207,033 — Total cash equivalents and marketable securities $ 257,853 $ 50,820 $ 207,033 $ — |
CASH EQUIVALENTS AND MARKETAB_2
CASH EQUIVALENTS AND MARKETABLE SECURITIES - (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | The table below summarizes the Company’s cash equivalents and marketable securities (in thousands): Amortized Gross Gross Estimated September 30, 2023 Assets Cash equivalents: Money market funds $ 3,417 $ — $ — $ 3,417 Total 3,417 — — 3,417 Marketable securities: U.S. government-sponsored entity debt securities 28,655 — (18) 28,637 Commercial paper securities 18,901 — (10) 18,891 Corporate debt securities 1,379 — — 1,379 Asset-backed securities 8,429 — — 8,429 U.S. treasury bills 5,599 — (18) 5,581 Certificates of deposit 12,684 1 (5) 12,680 Total 75,647 1 (51) 75,597 Total cash equivalents and marketable securities $ 79,064 $ 1 $ (51) $ 79,014 December 31, 2022 Assets Cash equivalents: Money market funds $ 50,820 $ — $ — $ 50,820 Total 50,820 — — 50,820 Marketable securities: U.S. government-sponsored entity debt securities 18,710 — (293) 18,417 Commercial paper securities 101,336 22 (193) 101,165 Corporate debt securities 11,760 — (90) 11,670 Asset-backed securities 24,970 2 (180) 24,792 U.S. treasury bills 7,950 — (12) 7,938 Certificates of deposit 37,599 4 (142) 37,461 Agency bonds 5,598 — (8) 5,590 Total 207,923 28 (918) 207,033 Total cash equivalents and marketable securities $ 258,743 $ 28 $ (918) $ 257,853 |
Fair value of investments available-for-sale | The fair value of marketable securities by contractual maturity were as follows (in thousands): September 30, December 31, Maturing in one year or less $ 41,173 $ 177,188 Maturing after one year through five years 34,424 29,845 Total $ 75,597 $ 207,033 |
MAJOR CUSTOMERS, PARTNERSHIPS_2
MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Disaggregation of Revenue | Revenues recognized under the agreement were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Revenue related to Kite agreement: Recognition of license fee fixed consideration $ 5,388 $ 6,296 $ 17,938 $ 18,682 Research services variable consideration 108 619 1,097 875 Total $ 5,496 $ 6,915 $ 19,035 $ 19,557 Revenues recognized under the agreement were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Revenue related to Novartis agreement: Recognition of upfront license fee $ — $ 7,582 $ 9,568 $ 23,222 Research services — 2,028 2,611 6,211 Total $ — $ 9,610 $ 12,179 $ 29,433 Revenues recognized under the agreement were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Revenue related to Biogen agreement: Recognition of license and other fixed consideration $ — $ 7,306 $ 132,165 $ 21,918 Cost-sharing payments for research services, net variable consideration — 2,107 2,684 8,740 Total $ — $ 9,413 $ 134,849 $ 30,658 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation Expense | The following table shows total stock-based compensation expense recognized in the accompanying Condensed Consolidated Statements of Operations (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 3,236 $ 4,395 $ 11,996 $ 13,656 General and administrative 2,953 3,398 9,260 9,746 Total stock-based compensation expense $ 6,189 $ 7,793 $ 21,256 $ 23,402 |
RESTRUCTURING CHARGES (Tables)
RESTRUCTURING CHARGES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Restructuring and Related Activities [Abstract] | |
Accrued Restructuring Costs | The following table is a summary of accrued April Restructuring costs included within other accrued liabilities on the Company’s Condensed Consolidated Balance Sheet as of September 30, 2023 (in thousands): Nine Months Ended September 30, 2023 Balance at December 31, 2022 $ — Restructuring charges 5,337 Cash payments (3,033) Non-cash adjustments (305) Balance at September 30, 2023 $ 1,999 |
ORGANIZATION, BASIS OF PRESEN_4
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2023 USD ($) $ / shares | |
Change in Accounting Estimate [Line Items] | ||
Capital resources | $ 132.1 | $ 132.1 |
Letter of credit established as a deposit | 1.5 | 1.5 |
Kite Pharma, Inc. | Change In Agreement Estimate, March 2023 | ||
Change in Accounting Estimate [Line Items] | ||
Increase in revenue | 8.9 | |
Decrease in net loss | $ 8.9 | |
Decreased net loss per share, basic (in dollars per share) | $ / shares | $ 0.05 | |
Decreased net loss per share, diluted (in dollars per share) | $ / shares | $ 0.05 | |
Kite Pharma, Inc. | Change In Estimate, September 2023 | ||
Change in Accounting Estimate [Line Items] | ||
Increase in revenue | 4.9 | $ 4.9 |
Decrease in net loss | $ 4.9 | $ 4.9 |
Decreased net loss per share, basic (in dollars per share) | $ / shares | $ 0.03 | $ 0.03 |
Decreased net loss per share, diluted (in dollars per share) | $ / shares | $ 0.03 | $ 0.03 |
ORGANIZATION, BASIS OF PRESEN_5
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenues from Strategic Partnering Collaboration And Licensing Agreements (Details) - Revenue from contract with customer - Customer concentration risk | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Kite Pharma, Inc. | ||||
Concentration Risk [Line Items] | ||||
Percentage of revenues | 58% | 26% | 11% | 23% |
Biogen MA, Inc. | ||||
Concentration Risk [Line Items] | ||||
Percentage of revenues | 4% | 36% | 77% | 36% |
Novartis Institutes for BioMedical Research, Inc. | ||||
Concentration Risk [Line Items] | ||||
Percentage of revenues | 0% | 36% | 7% | 35% |
Other licensing agreements | ||||
Concentration Risk [Line Items] | ||||
Percentage of revenues | 38% | 2% | 5% | 6% |
ORGANIZATION, BASIS OF PRESEN_6
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Reconciliation of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Cash and cash equivalents | $ 56,514 | $ 100,444 | $ 94,570 | $ 178,872 |
Non-current restricted cash | 1,500 | 1,500 | 1,500 | 1,500 |
Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows | $ 58,014 | $ 101,944 | $ 96,070 | $ 180,372 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | $ 75,597 | $ 207,033 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 3,417 | 50,820 |
U.S. government-sponsored entity debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 28,637 | 18,417 |
Commercial paper securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 18,891 | 101,165 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 1,379 | 11,670 |
Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 8,429 | 24,792 |
U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 5,581 | 7,938 |
Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 12,680 | 37,461 |
Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 5,590 | |
Fair value on recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 3,417 | 50,820 |
Total marketable securities | 75,597 | 207,033 |
Total cash equivalents and marketable securities | 79,014 | 257,853 |
Fair value on recurring basis | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 3,417 | 50,820 |
Fair value on recurring basis | U.S. government-sponsored entity debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 28,637 | 18,417 |
Fair value on recurring basis | Commercial paper securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 18,891 | 101,165 |
Fair value on recurring basis | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 1,379 | 11,670 |
Fair value on recurring basis | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 8,429 | 24,792 |
Fair value on recurring basis | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 5,581 | 7,938 |
Fair value on recurring basis | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 12,680 | 37,461 |
Fair value on recurring basis | Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 5,590 | |
Fair value on recurring basis | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 3,417 | 50,820 |
Total marketable securities | 0 | 0 |
Total cash equivalents and marketable securities | 3,417 | 50,820 |
Fair value on recurring basis | Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 3,417 | 50,820 |
Fair value on recurring basis | Level 1 | U.S. government-sponsored entity debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 1 | Commercial paper securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 1 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 1 | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 1 | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 1 | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 1 | Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | |
Fair value on recurring basis | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 0 | 0 |
Total marketable securities | 75,597 | 207,033 |
Total cash equivalents and marketable securities | 75,597 | 207,033 |
Fair value on recurring basis | Level 2 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 0 | 0 |
Fair value on recurring basis | Level 2 | U.S. government-sponsored entity debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 28,637 | 18,417 |
Fair value on recurring basis | Level 2 | Commercial paper securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 18,891 | 101,165 |
Fair value on recurring basis | Level 2 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 1,379 | 11,670 |
Fair value on recurring basis | Level 2 | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 8,429 | 24,792 |
Fair value on recurring basis | Level 2 | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 5,581 | 7,938 |
Fair value on recurring basis | Level 2 | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 12,680 | 37,461 |
Fair value on recurring basis | Level 2 | Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 5,590 | |
Fair value on recurring basis | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 0 | 0 |
Total marketable securities | 0 | 0 |
Total cash equivalents and marketable securities | 0 | 0 |
Fair value on recurring basis | Level 3 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 0 | 0 |
Fair value on recurring basis | Level 3 | U.S. government-sponsored entity debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 3 | Commercial paper securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 3 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 3 | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 3 | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 0 | 0 |
Fair value on recurring basis | Level 3 | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | $ 0 | 0 |
Fair value on recurring basis | Level 3 | Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | $ 0 |
CASH EQUIVALENTS AND MARKETAB_3
CASH EQUIVALENTS AND MARKETABLE SECURITIES - Summary of Cash Equivalents and Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Assets | ||||
Cash equivalents, amortized cost | $ 56,514 | $ 100,444 | $ 94,570 | $ 178,872 |
Marketable securities, amortized cost | 75,647 | 207,923 | ||
Marketable securities, gross unrealized gains | 1 | 28 | ||
Marketable securities, gross unrealized losses | (51) | (918) | ||
Marketable securities, estimated fair value | 75,597 | 207,033 | ||
Total cash equivalents and marketable securities, amortized cost | 79,064 | 258,743 | ||
Total cash equivalents and marketable securities, gross unrealized gains | 1 | 28 | ||
Total cash equivalents and marketable securities, gross unrealized losses | (51) | (918) | ||
Total cash equivalents and marketable securities, estimated fair value | 79,014 | 257,853 | ||
Money market funds | ||||
Assets | ||||
Cash equivalents, amortized cost | 3,417 | 50,820 | ||
Cash equivalents, gross unrealized gains | 0 | 0 | ||
Cash equivalents, gross unrealized losses | 0 | 0 | ||
Cash equivalents, estimated fair value | 3,417 | 50,820 | ||
Cash equivalents: | ||||
Assets | ||||
Cash equivalents, amortized cost | 3,417 | 50,820 | ||
Cash equivalents, gross unrealized gains | 0 | 0 | ||
Cash equivalents, gross unrealized losses | 0 | 0 | ||
Cash equivalents, estimated fair value | 3,417 | 50,820 | ||
U.S. government-sponsored entity debt securities | ||||
Assets | ||||
Marketable securities, amortized cost | 28,655 | 18,710 | ||
Marketable securities, gross unrealized gains | 0 | 0 | ||
Marketable securities, gross unrealized losses | (18) | (293) | ||
Marketable securities, estimated fair value | 28,637 | 18,417 | ||
Commercial paper securities | ||||
Assets | ||||
Marketable securities, amortized cost | 18,901 | 101,336 | ||
Marketable securities, gross unrealized gains | 0 | 22 | ||
Marketable securities, gross unrealized losses | (10) | (193) | ||
Marketable securities, estimated fair value | 18,891 | 101,165 | ||
Corporate debt securities | ||||
Assets | ||||
Marketable securities, amortized cost | 1,379 | 11,760 | ||
Marketable securities, gross unrealized gains | 0 | 0 | ||
Marketable securities, gross unrealized losses | 0 | (90) | ||
Marketable securities, estimated fair value | 1,379 | 11,670 | ||
Asset-backed securities | ||||
Assets | ||||
Marketable securities, amortized cost | 8,429 | 24,970 | ||
Marketable securities, gross unrealized gains | 0 | 2 | ||
Marketable securities, gross unrealized losses | 0 | (180) | ||
Marketable securities, estimated fair value | 8,429 | 24,792 | ||
U.S. treasury bills | ||||
Assets | ||||
Marketable securities, amortized cost | 5,599 | 7,950 | ||
Marketable securities, gross unrealized gains | 0 | 0 | ||
Marketable securities, gross unrealized losses | (18) | (12) | ||
Marketable securities, estimated fair value | 5,581 | 7,938 | ||
Certificates of deposit | ||||
Assets | ||||
Marketable securities, amortized cost | 12,684 | 37,599 | ||
Marketable securities, gross unrealized gains | 1 | 4 | ||
Marketable securities, gross unrealized losses | (5) | (142) | ||
Marketable securities, estimated fair value | $ 12,680 | 37,461 | ||
Agency bonds | ||||
Assets | ||||
Marketable securities, amortized cost | 5,598 | |||
Marketable securities, gross unrealized gains | 0 | |||
Marketable securities, gross unrealized losses | (8) | |||
Marketable securities, estimated fair value | $ 5,590 |
CASH EQUIVALENTS AND MARKETAB_4
CASH EQUIVALENTS AND MARKETABLE SECURITIES - Summary of Available-for-Sale Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Maturing in one year or less | $ 41,173 | $ 177,188 |
Maturing after one year through five years | 34,424 | 29,845 |
Total | $ 75,597 | $ 207,033 |
CASH EQUIVALENTS AND MARKETAB_5
CASH EQUIVALENTS AND MARKETABLE SECURITIES - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |||||
Realized investment gains (losses) | $ 0 | $ 0 | $ 0 | $ 0 | |
Allowance for credit loss related to marketable securities, not previously recorded | 0 | 0 | 0 | 0 | |
Allowance for credit loss related to marketable securities | 0 | 0 | $ 0 | ||
Non-current marketable securities investments reclassified to current | 34,400,000 | 34,400,000 | |||
Impairment charges | $ 400,000 | $ 0 | $ 400,000 | $ 0 |
BASIC AND DILUTED NET LOSS PE_2
BASIC AND DILUTED NET LOSS PER SHARE (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Earnings Per Share [Abstract] | ||
Antidilutive securities (in shares) | 22,131,291 | 18,524,016 |
MAJOR CUSTOMERS, PARTNERSHIPS_3
MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES - Pfizer Inc. (Details) $ in Millions | 1 Months Ended | 12 Months Ended | 70 Months Ended | 77 Months Ended | ||
Sep. 30, 2020 USD ($) | Dec. 31, 2017 USD ($) | May 31, 2017 USD ($) milestone | Dec. 31, 2020 USD ($) | Sep. 30, 2023 USD ($) milestone product | Sep. 30, 2023 USD ($) milestone | |
Pfizer Inc. | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Agreement termination, term | 15 years | |||||
Pfizer Inc. | S B Five Two Five And Other Products | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Revenues under agreement | $ 70 | |||||
Potential amount to be funded for achievement of specified commercialized and sales milestones | 266.5 | |||||
Pfizer Inc. | S B Five Two Five And Other Products | Achievement of specified clinical development intellectual property and regulatory milestones | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Development and sales-based milestone payments to be received | 208.5 | |||||
Pfizer Inc. | S B Five Two Five | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Milestone revenue receivable | 220 | |||||
Pfizer Inc. | Other products | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Milestone revenue receivable | $ 175 | |||||
Pfizer Inc. | License | Minimum | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Percentage of net sales per developed licensed product which will trigger royalties by counterparty | 14% | 14% | ||||
Pfizer Inc. | License | Maximum | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Percentage of net sales per developed licensed product which will trigger royalties by counterparty | 20% | 20% | ||||
Pfizer Inc. | C9ORF72 | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Revenues under agreement | $ 5 | $ 5 | ||||
Development and sales-based milestone payments to be received | $ 5 | |||||
Collaborative arrangement transaction price | $ 17 | |||||
Pfizer SB-525 | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Revenues under agreement | $ 55 | |||||
Collaborative arrangement transaction price | 134 | |||||
Research service fees | $ 79 | |||||
Pfizer SB-525 | S B Five Two Five And Other Products | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Collaborative arrangement, number of milestones achieved | milestone | 2 | 2 | ||||
Milestone payments received | $ 55 | |||||
Pfizer C9ORF72 | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Agreement termination, term | 15 years | |||||
Pfizer C9ORF72 | C9ORF72 | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Revenues under agreement | $ 12 | |||||
Milestone payments received | 12 | $ 5 | ||||
Number of products approved | product | 0 | |||||
Number of milestones included in transaction price | milestone | 0 | |||||
Pfizer C9ORF72 | C9ORF72 | Achievement Of Specified Preclinical Development Clinical Development And First Commercial Sale Milestones | Maximum | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Development and sales-based milestone payments to be received | 60 | |||||
Pfizer C9ORF72 | C9ORF72 | Achievement Of Commercial Milestones | Maximum | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Development and sales-based milestone payments to be received | $ 90 |
MAJOR CUSTOMERS, PARTNERSHIPS_4
MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES - Kite Pharma, Inc. (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 USD ($) performance_obligation material_right | Apr. 30, 2018 USD ($) option milestone | Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Accounts receivable | $ 1,148 | $ 1,148 | $ 3,678 | ||
Kite Pharma, Inc. | Change In Agreement Estimate, March 2023 | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Increase in revenue | 8,900 | ||||
Decrease in net loss | $ 8,900 | ||||
Increased earnings per share, basic (in dollars per share) | $ / shares | $ (0.05) | ||||
Increased earnings per share, diluted (in dollars per share) | $ / shares | $ (0.05) | ||||
Kite Pharma, Inc. | Change In Estimate, September 2023 | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Increase in revenue | 4,900 | $ 4,900 | |||
Decrease in net loss | $ 4,900 | $ 4,900 | |||
Increased earnings per share, basic (in dollars per share) | $ / shares | $ (0.03) | $ (0.03) | |||
Increased earnings per share, diluted (in dollars per share) | $ / shares | $ (0.03) | $ (0.03) | |||
Kite Pharma, Inc. | License and Service | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Remaining performance obligation amount, related to material rights | $ 1,500 | $ 1,500 | 1,500 | ||
Kite Pharma, Inc. | License and Service | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-01-01 | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Remaining performance obligation amount | $ 21,200 | ||||
Remaining performance obligation, expected timing of satisfaction period | 12 months | ||||
Kite Pharma, Inc. | License and Service | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01 | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Remaining performance obligation amount | $ 1,500 | $ 1,500 | |||
Remaining performance obligation, expected timing of satisfaction period | 12 months | 12 months | |||
Kite Pharma, Inc. | License | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Contract with customer liability | $ 150,000 | ||||
Number of remaining performance obligations | performance_obligation | 4 | ||||
Number of material rights for renewal of research period | material_right | 2 | ||||
Renewal period | 1 year | ||||
Fixed consideration | $ 150,000 | ||||
Kite Pharma, Inc. | Collaboration And License Agreement | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Milestone payments received | $ 150,000 | ||||
Initial research term of agreement | 6 years | ||||
Number of options to extend initial research term | option | 2 | ||||
Extended research term of agreement | 1 year | ||||
Separate fee for additional term | $ 10,000 | ||||
Contract with customer liability | $ 1,500 | $ 1,500 | $ 19,400 | ||
Accounts receivable | $ 200 | $ 200 | $ 700 | ||
Kite Pharma, Inc. | Collaboration And License Agreement | Achievement of specified research, clinical development, regulatory and first commercial sale milestones | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Contingent development and sales-based milestone payments to be received | 1,300,000 | ||||
Kite Pharma, Inc. | Collaboration And License Agreement | Achievement of specified sales-based milestones if annual worldwide net sales of licensed products reach specified levels | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Contingent development and sales-based milestone payments to be received | $ 1,800,000 | ||||
Maximum amount of achieved milestones to receive payment | milestone | 10 | ||||
Kite Pharma, Inc. | Collaboration And License Agreement | Maximum | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Development and sales-based milestone payments to be received | $ 3,000,000 |
MAJOR CUSTOMERS, PARTNERSHIPS_5
MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES - Revenues Recognized under Agreement (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue related to Sanofi agreement: | ||||
Revenues | $ 9,398 | $ 26,460 | $ 174,190 | $ 84,069 |
Kite Pharma, Inc. | ||||
Revenue related to Sanofi agreement: | ||||
Revenues | 5,496 | 6,915 | 19,035 | 19,557 |
Kite Pharma, Inc. | License | ||||
Revenue related to Sanofi agreement: | ||||
Revenues | 5,388 | 6,296 | 17,938 | 18,682 |
Kite Pharma, Inc. | Service | ||||
Revenue related to Sanofi agreement: | ||||
Revenues | 108 | 619 | 1,097 | 875 |
Novartis Institutes for BioMedical Research, Inc. | ||||
Revenue related to Sanofi agreement: | ||||
Revenues | 0 | 9,610 | 12,179 | 29,433 |
Novartis Institutes for BioMedical Research, Inc. | License | ||||
Revenue related to Sanofi agreement: | ||||
Revenues | 0 | 7,582 | 9,568 | 23,222 |
Novartis Institutes for BioMedical Research, Inc. | Service | ||||
Revenue related to Sanofi agreement: | ||||
Revenues | 0 | 2,028 | 2,611 | 6,211 |
Biogen MA, Inc. | ||||
Revenue related to Sanofi agreement: | ||||
Revenues | 0 | 9,413 | 134,849 | 30,658 |
Biogen MA, Inc. | License | ||||
Revenue related to Sanofi agreement: | ||||
Revenues | 0 | 7,306 | 132,165 | 21,918 |
Biogen MA, Inc. | Service | ||||
Revenue related to Sanofi agreement: | ||||
Revenues | $ 0 | $ 2,107 | $ 2,684 | $ 8,740 |
MAJOR CUSTOMERS, PARTNERSHIPS_6
MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES - Novartis Institutes for BioMedical Research, Inc. (Details) - USD ($) | Jul. 27, 2020 | Sep. 30, 2023 | Dec. 31, 2022 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Accounts receivable | $ 1,148,000 | $ 3,678,000 | |
Novartis Institutes for BioMedical Research, Inc. | Collaboration And License Agreement | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Proceeds from collaborators | $ 75,000,000 | ||
Collaborative arrangement transaction price | 95,100,000 | ||
Collaborative arrangement, license fee | 75,000,000 | ||
Collaborative arrangement estimated reimbursable service costs | $ 20,100,000 | ||
Accounts receivable | 0 | 2,200,000 | |
Deferred revenue | $ 0 | $ 9,600,000 |
MAJOR CUSTOMERS, PARTNERSHIPS_7
MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES - Biogen MA, Inc. (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Jun. 15, 2023 USD ($) | Mar. 31, 2023 USD ($) | May 31, 2020 USD ($) | Apr. 30, 2020 USD ($) product_target $ / shares shares | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2020 USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Number of additional neurological disease gene targets (in product targets) | product_target | 7 | |||||||||
Accounts receivable | $ 1,148,000 | $ 1,148,000 | $ 3,678,000 | |||||||
General and administrative expense | 13,918,000 | $ 16,238,000 | 48,068,000 | $ 46,239,000 | ||||||
Biogen MA, Inc. | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Change in estimate of transaction price, increase in revenue | $ 127,100,000 | |||||||||
Biogen MA, Inc. | License and Service | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Fixed consideration | $ 204,600,000 | |||||||||
Remaining performance obligation amount | 0 | 0 | 151,300,000 | |||||||
Cumulative catch-up to expense | $ 2,500,000 | |||||||||
General and administrative expense | 0 | $ 100,000 | 2,600,000 | $ 400,000 | ||||||
Biogen MA, Inc. | Stock Purchase Agreement | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Sale of stock, number of shares issued in transaction (in shares) | shares | 24,420,157 | |||||||||
Sale of stock, price per share (in dollars per share) | $ / shares | $ 9.2137 | |||||||||
Consideration received on transaction | $ 225,000,000 | |||||||||
Sale of stock, excess consideration received on transaction | 79,600,000 | |||||||||
Collaboration agreement, equity issued | 145,400,000 | |||||||||
Accounts receivable | 0 | 0 | 500,000 | |||||||
Deferred revenue | 0 | 0 | $ 132,200,000 | |||||||
Biogen MA, Inc. | Collaboration And License Agreement | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Proceeds from collaborators | $ 125,000,000 | $ 125,000,000 | ||||||||
Number of neurological disease gene targets selected by counterparty (in product targets) | product_target | 4 | |||||||||
Financial advisory fees | $ 7,000,000 | |||||||||
Percent of initial recognition | 2% | |||||||||
Contract with customer, asset, after allowance for credit Loss | $ 4,100,000 | $ 4,100,000 |
IMPAIRMENT OF GOODWILL, INDEF_2
IMPAIRMENT OF GOODWILL, INDEFINITE-LIVED INTANGIBLE ASSETS AND OTHER LONG-LIVED ASSETS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Impaired Long-Lived Assets Held and Used [Line Items] | ||||||
Goodwill impairment | $ 38,100,000 | |||||
Impairment on right-of-use assets | $ 17,600,000 | 11,200,000 | ||||
Impairment of long-lived assets | 44,799,000 | $ 0 | $ 0 | $ 65,232,000 | $ 0 | |
Impairment of intangible assets, indefinite-lived | 51,300,000 | |||||
Reduction in deferred tax liabilities | $ 6,300,000 | |||||
Leasehold Improvements | ||||||
Impaired Long-Lived Assets Held and Used [Line Items] | ||||||
Impairment of long-lived assets | 5,000,000 | |||||
Construction in Progress | ||||||
Impaired Long-Lived Assets Held and Used [Line Items] | ||||||
Impairment of long-lived assets | $ 4,200,000 | |||||
Leasehold Improvements and Construction-in-Progress | ||||||
Impaired Long-Lived Assets Held and Used [Line Items] | ||||||
Impairment of long-lived assets | 13,700,000 | |||||
Furniture, Fixtures and Laboratory and Manufacturing Equipment | ||||||
Impaired Long-Lived Assets Held and Used [Line Items] | ||||||
Impairment of long-lived assets | $ 13,500,000 |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 6,189 | $ 7,793 | $ 21,256 | $ 23,402 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 3,236 | 4,395 | 11,996 | 13,656 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 2,953 | $ 3,398 | $ 9,260 | $ 9,746 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - Jefferies LLC - At-The-Market Offering Agreement - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Dec. 31, 2022 | Aug. 31, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock offering program, maximum value | $ 150 | |||||
Stock offering program, increase to aggregate offering price | $ 175 | |||||
Issuance of common stock in at-the-market offering, net of offering expenses (in shares) | 0 | 8,483,104 | 8,249,261 | 14,711,770 | ||
Consideration received on transaction | $ 42.2 | $ 15.1 | $ 66.4 |
RESTRUCTURING CHARGES - Narrati
RESTRUCTURING CHARGES - Narrative (Details) | 3 Months Ended | 9 Months Ended | |
Apr. 26, 2023 employee | Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | |
Restructuring Cost and Reserve [Line Items] | |||
Restructuring charges | $ 5,337,000 | ||
April 2023 Restructuring Plan | |||
Restructuring Cost and Reserve [Line Items] | |||
Number of employees eliminated in restructuring | employee | 110 | ||
Percentage of positions eliminated in restructuring | 23% | ||
Restructuring charges | $ 0 | 5,300,000 | |
Research and development | April 2023 Restructuring Plan | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring charges | 4,100,000 | ||
General and administrative | April 2023 Restructuring Plan | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring charges | $ 1,200,000 | ||
Full-Time Employees | April 2023 Restructuring Plan | |||
Restructuring Cost and Reserve [Line Items] | |||
Number of employees eliminated in restructuring | employee | 55 | ||
Contracted Employees | April 2023 Restructuring Plan | |||
Restructuring Cost and Reserve [Line Items] | |||
Number of employees eliminated in restructuring | employee | 55 |
RESTRUCTURING CHARGES - Accrued
RESTRUCTURING CHARGES - Accrued Restructuring Costs (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Restructuring Reserve [Roll Forward] | |
Balance at December 31, 2022 | $ 0 |
Restructuring charges | 5,337 |
Cash payments | (3,033) |
Non-cash adjustments | (305) |
Balance at September 30, 2023 | $ 1,999 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Income tax expense (benefit) | $ 1,270 | $ 30 | $ (4,800) | $ 170 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - Subsequent Event $ in Millions | Oct. 28, 2023 | Oct. 11, 2023 USD ($) employee |
Approval Of Amended And Restated Executive Severance Plan | ||
Subsequent Event [Line Items] | ||
Executive severance plan, severance benefits, lump sum, payment period | 60 days | |
Minimum | Approval Of Amended And Restated Executive Severance Plan | ||
Subsequent Event [Line Items] | ||
Executive severance plan, severance benefits, termination period | 9 months | |
Maximum | Approval Of Amended And Restated Executive Severance Plan | ||
Subsequent Event [Line Items] | ||
Executive severance plan, severance benefits, termination period | 18 months | |
November 2023 Restructuring Plan | ||
Subsequent Event [Line Items] | ||
Number of employees eliminated in restructuring | employee | 162 | |
Percentage of positions eliminated in restructuring | 40% | |
November 2023 Restructuring Plan | Minimum | ||
Subsequent Event [Line Items] | ||
Restructuring expected cost | $ 8 | |
November 2023 Restructuring Plan | Maximum | ||
Subsequent Event [Line Items] | ||
Restructuring expected cost | $ 10 |