Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 31, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-35966 | |
Entity Registrant Name | bluebird bio, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 13-3680878 | |
Entity Address, Address Line One | 60 Binney Street | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 339 | |
Local Phone Number | 499-9300 | |
Title of 12(b) Security | Common Stock, $0.01 par value per share | |
Trading Symbol | BLUE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 66,222,965 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001293971 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 1,198,768 | $ 327,214 |
Marketable securities | 350,614 | 779,246 |
Prepaid expenses | 39,358 | 32,888 |
Receivables and other current assets | 24,705 | 12,826 |
Total current assets | 1,613,445 | 1,152,174 |
Marketable securities | 49,411 | 131,506 |
Property, plant and equipment, net | 155,376 | 151,176 |
Intangible assets, net | 12,183 | 14,326 |
Goodwill | 13,128 | 13,128 |
Operating lease right-of-use assets | 189,464 | 185,885 |
Restricted cash and other non-current assets | 74,783 | 79,229 |
Total assets | 2,107,790 | 1,727,424 |
Current liabilities: | ||
Accounts payable | 26,181 | 42,995 |
Accrued expenses and other current liabilities | 135,612 | 141,556 |
Operating lease liability, current portion | 20,955 | 20,175 |
Deferred revenue, current portion | 3,915 | 8,474 |
Collaboration research advancement, current portion | 10,518 | 10,380 |
Total current liabilities | 197,181 | 223,580 |
Deferred revenue, net of current portion | 25,762 | 9,791 |
Collaboration research advancement, net of current portion | 23,917 | 27,834 |
Operating lease liability, net of current portion | 174,564 | 170,812 |
Other non-current liabilities | 4,335 | 10,414 |
Total liabilities | 425,759 | 442,431 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value, 5,000 shares authorized; 0 shares issued and outstanding at June 30, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.01 par value, 125,000 shares authorized; 66,196 and 55,368 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 662 | 554 |
Additional paid-in capital | 4,189,697 | 3,568,184 |
Accumulated other comprehensive loss | (2,400) | (1,893) |
Accumulated deficit | (2,505,928) | (2,281,852) |
Total stockholders’ equity | 1,682,031 | 1,284,993 |
Total liabilities and stockholders’ equity | $ 2,107,790 | $ 1,727,424 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
Stockholders’ equity: | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par or stated value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 |
Common stock, shares, issued (in shares) | 66,196,000 | 55,368,000 |
Common stock, shares, outstanding (in shares) | 66,196,000 | 55,368,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenue: | ||||
Collaborative arrangement revenue | $ 109,674 | $ 465 | $ 111,976 | $ 2,431 |
Total revenues | 198,890 | 13,296 | 220,753 | 25,767 |
Operating expenses: | ||||
Research and development | 156,308 | 146,540 | 310,431 | 269,180 |
Selling, general and administrative | 68,628 | 68,631 | 141,876 | 128,910 |
Cost of royalty and other revenue | 1,554 | 613 | 2,579 | 1,043 |
Change in fair value of contingent consideration | (1,655) | 214 | (4,763) | 510 |
Total operating expenses | 224,835 | 215,998 | 450,123 | 399,643 |
Loss from operations | (25,945) | (202,702) | (229,370) | (373,876) |
Interest income, net | 2,939 | 9,387 | 8,294 | 19,489 |
Other income (expense), net | 1,551 | (2,936) | (2,896) | (6,325) |
Loss before income taxes | (21,455) | (196,251) | (223,972) | (360,712) |
Income tax (expense) benefit | (10) | 469 | (104) | 484 |
Net loss | $ (21,465) | $ (195,782) | $ (224,076) | $ (360,228) |
Net loss per share - basic and diluted: (in dollars per share) | $ (0.36) | $ (3.55) | $ (3.86) | $ (6.54) |
Weighted-average number of common shares used in computing net loss per share - basic and diluted: (in shares) | 60,384 | 55,165 | 57,987 | 55,062 |
Other comprehensive income (loss): | ||||
Other comprehensive income (loss), net of tax expense of $0.1 million and $0.8 million for the three months ended June 30, 2020 and 2019, respectively, and $0.1 million and $1.3 million for the six months ended June 30, 2020 and 2019, respectively | $ 399 | $ 973 | $ (507) | $ 2,808 |
Comprehensive loss | (21,066) | (194,809) | (224,583) | (357,420) |
Service revenue | ||||
Revenue: | ||||
Revenue | 78,357 | 11,093 | 95,190 | 20,304 |
Royalty and other revenue | ||||
Revenue: | ||||
Revenue | $ 10,859 | $ 1,738 | $ 13,587 | $ 3,032 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Statement [Abstract] | ||||
Other comprehensive income (loss), tax | $ 0.1 | $ 0.8 | $ 0.1 | $ 1.3 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Cumulative Effect, Period of Adoption, Adjustment | Common stock | Additional paid-in capital | Accumulated other comprehensive loss | Accumulated deficit | Accumulated deficitCumulative Effect, Period of Adoption, Adjustment |
Beginning balance (in shares) at Dec. 31, 2018 | 54,738 | ||||||
Beginning balance at Dec. 31, 2018 | $ 1,885,070 | $ 6,564 | $ 547 | $ 3,386,958 | $ (3,627) | $ (1,498,808) | $ 6,564 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Vesting of restricted stock units (in shares) | 131 | ||||||
Vesting of restricted stock units | 0 | $ 2 | (2) | ||||
Exercise of stock options, shares (in shares) | 189 | ||||||
Exercise of stock options | 9,504 | $ 2 | 9,502 | ||||
Purchase of common stock under ESPP (in shares) | 11 | ||||||
Purchase of common stock under ESPP | 1,231 | 1,231 | |||||
Stock-based compensation | 32,341 | 32,341 | |||||
Other comprehensive loss | 1,835 | 1,835 | |||||
Net loss | (164,446) | (164,446) | |||||
Ending balance, shares (in shares) at Mar. 31, 2019 | 55,069 | ||||||
Ending balance at Mar. 31, 2019 | 1,772,099 | $ 551 | 3,430,030 | (1,792) | (1,656,690) | ||
Beginning balance (in shares) at Dec. 31, 2018 | 54,738 | ||||||
Beginning balance at Dec. 31, 2018 | 1,885,070 | $ 6,564 | $ 547 | 3,386,958 | (3,627) | (1,498,808) | $ 6,564 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Other comprehensive loss | 2,808 | ||||||
Net loss | (360,228) | ||||||
Ending balance, shares (in shares) at Jun. 30, 2019 | 55,228 | ||||||
Ending balance at Jun. 30, 2019 | 1,636,374 | $ 553 | 3,489,112 | (819) | (1,852,472) | ||
Beginning balance (in shares) at Mar. 31, 2019 | 55,069 | ||||||
Beginning balance at Mar. 31, 2019 | 1,772,099 | $ 551 | 3,430,030 | (1,792) | (1,656,690) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Vesting of restricted stock units (in shares) | 66 | ||||||
Vesting of restricted stock units | 0 | $ 1 | (1) | ||||
Exercise of stock options, shares (in shares) | 93 | ||||||
Exercise of stock options | 3,973 | $ 1 | 3,972 | ||||
Stock-based compensation | 55,111 | 55,111 | |||||
Other comprehensive loss | 973 | 973 | |||||
Net loss | (195,782) | (195,782) | |||||
Ending balance, shares (in shares) at Jun. 30, 2019 | 55,228 | ||||||
Ending balance at Jun. 30, 2019 | $ 1,636,374 | $ 553 | 3,489,112 | (819) | (1,852,472) | ||
Beginning balance (in shares) at Dec. 31, 2019 | 55,368 | 55,368 | |||||
Beginning balance at Dec. 31, 2019 | $ 1,284,993 | $ 554 | 3,568,184 | (1,893) | (2,281,852) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Vesting of restricted stock units (in shares) | 204 | ||||||
Vesting of restricted stock units | 0 | $ 2 | (2) | ||||
Exercise of stock options, shares (in shares) | 20 | ||||||
Exercise of stock options | 750 | 750 | |||||
Purchase of common stock under ESPP (in shares) | 28 | ||||||
Purchase of common stock under ESPP | 1,872 | 1,872 | |||||
Stock-based compensation | 36,335 | 36,335 | |||||
Other comprehensive loss | (906) | (906) | |||||
Net loss | (202,611) | (202,611) | |||||
Ending balance, shares (in shares) at Mar. 31, 2020 | 55,620 | ||||||
Ending balance at Mar. 31, 2020 | $ 1,120,433 | $ 556 | 3,607,139 | (2,799) | (2,484,463) | ||
Beginning balance (in shares) at Dec. 31, 2019 | 55,368 | 55,368 | |||||
Beginning balance at Dec. 31, 2019 | $ 1,284,993 | $ 554 | 3,568,184 | (1,893) | (2,281,852) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Exercise of stock options, shares (in shares) | 27 | ||||||
Other comprehensive loss | $ (507) | ||||||
Net loss | $ (224,076) | ||||||
Ending balance, shares (in shares) at Jun. 30, 2020 | 66,196 | 66,196 | |||||
Ending balance at Jun. 30, 2020 | $ 1,682,031 | $ 662 | 4,189,697 | (2,400) | (2,505,928) | ||
Beginning balance (in shares) at Mar. 31, 2020 | 55,620 | ||||||
Beginning balance at Mar. 31, 2020 | 1,120,433 | $ 556 | 3,607,139 | (2,799) | (2,484,463) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of common stock upon public offering, net of issuance costs (in shares) | 10,455 | ||||||
Issuance of common stock upon public offering, net of issuance costs of $33,465 | 541,536 | $ 105 | 541,431 | ||||
Vesting of restricted stock units (in shares) | 114 | ||||||
Vesting of restricted stock units | 0 | $ 1 | (1) | ||||
Exercise of stock options, shares (in shares) | 7 | ||||||
Exercise of stock options | 347 | 347 | |||||
Stock-based compensation | 40,781 | 40,781 | |||||
Other comprehensive loss | 399 | 399 | |||||
Net loss | $ (21,465) | (21,465) | |||||
Ending balance, shares (in shares) at Jun. 30, 2020 | 66,196 | 66,196 | |||||
Ending balance at Jun. 30, 2020 | $ 1,682,031 | $ 662 | $ 4,189,697 | $ (2,400) | $ (2,505,928) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) $ in Thousands, shares in Millions | 3 Months Ended |
Jun. 30, 2020USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Costs from initial public offering | $ 33,465 |
Issuance of common stock upon public offering, net of issuance costs of $33,465 | 541,536 |
Other comprehensive loss | 399 |
Vesting of restricted stock units | $ 0 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (224,076) | $ (360,228) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Change in fair value of contingent consideration | (4,763) | 510 |
Depreciation and amortization | 9,430 | 7,831 |
Stock-based compensation expense | 84,822 | 87,452 |
Unrealized loss on equity securities | 3,343 | 6,184 |
Other non-cash items | (1,841) | (7,064) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (13,813) | (20,694) |
Operating lease right-of-use assets | 11,085 | 11,037 |
Accounts payable | (14,042) | 6,652 |
Accrued expenses and other liabilities | (14,025) | (9,301) |
Operating lease liabilities | (10,131) | (259) |
Deferred revenue | 11,412 | (11,716) |
Collaboration research advancement | (3,779) | (2,431) |
Net cash used in operating activities | (166,378) | (292,027) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (15,478) | (37,925) |
Purchases of marketable securities | (101,421) | (471,365) |
Sales of marketable securities | 29,878 | 0 |
Proceeds from maturities of marketable securities | 580,875 | 704,803 |
Net cash provided by investing activities | 493,854 | 195,513 |
Cash flows from financing activities: | ||
Proceeds from public offering of common stock, net of issuance costs | 541,536 | 0 |
Proceeds from exercise of stock options and ESPP contributions | 2,549 | 15,004 |
Net cash provided by financing activities | 544,085 | 15,004 |
Increase (decrease) in cash, cash equivalents and restricted cash | 871,561 | (81,510) |
Cash, cash equivalents and restricted cash at beginning of period | 381,709 | 417,099 |
Cash, cash equivalents and restricted cash at end of period | 1,253,270 | 335,589 |
Reconciliation of cash, cash equivalents and restricted cash: | ||
Total cash, cash equivalents and restricted cash | 1,253,270 | 335,589 |
Supplemental cash flow disclosures from investing and financing activities: | ||
Purchases of property, plant and equipment included in accounts payable and accrued expenses | 1,257 | 8,869 |
Right-of-use assets obtained in exchange for operating lease liabilities | $ 14,663 | $ 17,489 |
Income taxes
Income taxes | 6 Months Ended |
Jun. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income taxes | Income taxes Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using statutory rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized. Due to the uncertainty surrounding the realization of the favorable tax attributes in future tax returns, the Company has recorded a full valuation allowance against the Company’s otherwise recognizable net deferred tax assets. The tax expense recognized during the three and six months ended June 30, 2020 is due to income taxes on foreign earnings, offset by a deferred tax benefit for which a corresponding tax expense is recognized in other comprehensive income (loss). In March 2020, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was enacted. This law temporarily suspended and adjusted certain law changes enacted in the Tax Cuts and Jobs Act in 2017. The Company has concluded that the provisions in the CARES Act have an immaterial impact on the Company’s income tax expense, net deferred tax assets and associated valuation allowance. |
Description of the business
Description of the business | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of the business | Description of the business bluebird bio, Inc. (the “Company” or “bluebird”) was incorporated in Delaware on April 16, 1992, and is headquartered in Cambridge, Massachusetts. The Company is a biotechnology company committed to researching, developing and commercializing potentially transformative gene therapies for severe genetic diseases and cancer. Since its inception, the Company has devoted substantially all of its resources to its research and development efforts relating to its product candidates, including activities to manufacture product candidates, conduct clinical studies of its product candidates, perform preclinical research to identify new product candidates and provide selling, general and administrative support for these operations, including commercial-readiness activities. The Company’s programs in severe genetic diseases include betibeglogene autotemcel (beti-cel; formerly LentiGlobin for β-thalassemia gene therapy) as a treatment for transfusion-dependent β-thalassemia, or TDT; its LentiGlobin ® product candidate as a treatment for sickle cell disease, or SCD; and elivaldogene autotemcel (eli-cel; formerly Lenti-D gene therapy) as a treatment for cerebral adrenoleukodystrophy, or CALD. The Company’s programs in oncology are focused on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR) and T cell receptor (TCR) T cell therapies. Idecabtagene vicleucel, or ide-cel, and bb21217, are product candidates in oncology under the Company’s collaboration arrangement with Bristol-Myers Squibb ("BMS"), formerly Celgene Corporation ("Celgene") prior to its acquisition by BMS in November 2019. ide-cel and bb21217 are CAR T cell product candidates for the treatment of multiple myeloma. Please refer to Note 9, Collaborative arrangements, for further discussion of the Company’s collaboration with BMS. In June 2019, the Company received conditional marketing authorization from the European Commission for beti-cel as a treatment of patients 12 years and older with TDT who do not have a β 0 /β 0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte-matched related HSC donor is not available. beti-cel is being marketed as ZYNTEGLO™ in the European Union. Through June 30, 2020, the Company had not generated any revenue from product sales of ZYNTEGLO. |
Basis of presentation, principl
Basis of presentation, principles of consolidation and significant accounting policies | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Basis of presentation, principles of consolidation and significant accounting policies | Basis of presentation, principles of consolidation and significant accounting policies Basis of presentation The accompanying condensed consolidated financial statements are unaudited and have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) as found in the Accounting Standards Codification ("ASC") and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These condensed consolidated financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position and results of operations for the interim periods ended June 30, 2020 and 2019. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2019, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 18, 2020. Certain items in the prior year’s condensed consolidated financial statements have been reclassified to conform to the current presentation. However, no subtotals in the prior year condensed consolidated financial statements were impacted as a result. Amounts reported are computed based on thousands. As a result, certain totals may not sum due to rounding. The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to GAAP. The Company views its operations and manages its business in one operating segment. Significant accounting policies The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and six months ended June 30, 2020 are consistent with those discussed in Note 2 to the consolidated financial statements included in the Company’s 2019 Annual Report on Form 10-K, except as noted immediately below and as noted within the "Recent accounting pronouncements - Recently adopted" section. Marketable securities Effective January 1, 2020, the Company adopted ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements ("ASU 2016-13" or "ASC 326"), using the effective date method. As the Company had never recorded any other-than-temporary-impairment adjustments to its available-for-sale debt securities prior to the effective date, no transition provisions are applicable to the Company. The Company assesses its available-for-sale debt securities under the available-for-sale debt security impairment model in ASC 326 as of each reporting date in order to determine if a portion of any decline in fair value below carrying value recognized on its available-for-sale debt securities is the result of a credit loss. The Company records credit losses in the condensed consolidated statements of operations and comprehensive loss as credit loss expense within other expense, net, which is limited to the difference between the fair value and the amortized cost of the security. To date, the Company has not recorded any credit losses on its available-for-sale debt securities. Accrued interest receivable related to the Company's available-for-sale debt securities is presented within receivables and other current assets on the Company's condensed consolidated balance sheets. The Company has elected the practical expedient available to exclude accrued interest receivable from both the fair value and the amortized cost basis of available-for-sale debt securities for the purposes of identifying and measuring any impairment. The Company writes off accrued interest receivable once it has determined that the asset is not realizable. Any write offs of accrued interest receivable are recorded by reversing interest income, recognizing credit loss expense, or a combination of both. To date, the Company has not written off any accrued interest receivables associated with its marketable securities. Stock-based compensation The Company estimates the fair value of its option awards using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate, and (iv) expected dividends. Effective January 1, 2020, the Company eliminated the use of a representative peer group and uses only its own historical volatility data in its estimate of expected volatility given that there is now a sufficient amount of historical information regarding the volatility of its own stock price. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements. Estimates are used in the following areas, among others: future undiscounted cash flows and subsequent fair value estimates used to assess potential and measure any impairment of long-lived assets, including goodwill and intangible assets, and the measurement of right-of-use assets and lease liabilities, contingent consideration, stock-based compensation expense, accrued expenses, revenue, income taxes, and the assessment of the Company's ability to fund its operations for at least the next twelve months from the date of issuance of these financial statements. Recent accounting pronouncements Recently adopted ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements, ASU No. 2019-5 Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief, ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments - Credit Losses In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements . The new standard, as amended, requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. The targeted transition relief standard allows filers an option to irrevocably elect the fair value option of ASC 825-10, Financial Instruments-Overall , applied on an instrument-by-instrument basis for eligible instruments. The Company adopted this standard on January 1, 2020 on a prospective basis and the adoption did not have a material impact on its financial position and results of operations. ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement. The new standard removes certain disclosures, modifies certain disclosures, and adds additional disclosures related to fair value measurement. The Company adopted this standard on January 1, 2020, and it did not have a material impact on its financial position and results of operations upon adoption. ASU No. 2018-15, Intangibles-Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . The amendments in this update align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). The accounting for the service element of a hosting arrangement that is a service contract is not affected by the amendments in this update. The Company adopted this standard on a prospective basis as of January 1, 2020, and it did not have a material impact on its financial position and results of operations upon adoption. ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 , (“ASU 2018-18”). The amendments in this update clarify that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606 , Revenue from Contracts with Customers (“Topic 606” or "ASC 606") when the counter party is a customer in the context of a unit of account. ASU 2018-18 also precludes companies from presenting transactions with collaborative partners that are outside the scope of Topic 606 together with revenue within the scope of Topic 606. The Company adopted this standard on a retrospective basis on January 1, 2020. As a result, revenue for prior periods are presented in accordance with the new standard. Prior to the adoption of ASU 2018-18, the Company presented all revenue recognized under its collaborative arrangements as collaboration revenue on its condensed consolidated statement of operations and comprehensive loss. However, as the Company recognizes revenue under its collaborative arrangements both within and outside the scope of Topic 606, the Company has revised its presentation of revenue on its condensed consolidated statement of operations and comprehensive loss as follows: service revenue includes revenue from collaborative partners recognized within the scope of Topic 606 and collaborative arrangement revenue includes revenue from collaborative partners recognized outside the scope of Topic 606. The disaggregation of revenue recognized under Topic 606 and outside of Topic 606 had previously otherwise been disclosed in the Notes to Condensed Consolidated Financial Statements. ASU No. 2019-4, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments In April 2019, the FASB issued ASU 2019-4, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments. This update provides clarifications for three topics related to financial instruments accounting, some of which apply to the Company. The Company adopted this standard on January 1, 2020 on a prospective basis, and it did not have a material impact on its financial position and results of operations upon adoption. Not yet adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ("ASU 2019-12"), which is intended to simplify the accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The new standard will be effective beginning January 1, 2021. The Company is currently evaluating the potential impact ASU 2019-12 may have on its financial position and results of operations upon adoption. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable securities | Marketable securities The following table summarizes the marketable securities held at June 30, 2020 and December 31, 2019 (in thousands): Description Amortized cost / Cost Unrealized gains Unrealized losses Fair value June 30, 2020 U.S. government agency securities and treasuries $ 201,362 $ 1,294 $ (5) $ 202,651 Corporate bonds 151,305 1,620 — 152,925 Commercial paper 34,922 — — 34,922 Equity securities 20,017 — (10,490) 9,527 Total $ 407,606 $ 2,914 $ (10,495) $ 400,025 December 31, 2019 U.S. government agency securities and treasuries $ 633,970 $ 2,014 $ (48) $ 635,936 Certificates of deposit 960 — — 960 Corporate bonds 185,827 824 (43) 186,608 Commercial paper 74,378 — — 74,378 Equity securities 20,017 — (7,147) 12,870 Total $ 915,152 $ 2,838 $ (7,238) $ 910,752 No available-for-sale debt securities held as of June 30, 2020 or December 31, 2019 had remaining maturities greater than five years. |
Fair value measurements
Fair value measurements | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Fair value measurements The following table sets forth the Company’s assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2020 and December 31, 2019 (in thousands): Description Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) June 30, 2020 Assets: Cash and cash equivalents $ 1,198,768 $ 1,198,768 $ — $ — Marketable securities: U.S. government agency securities and treasuries 202,651 — 202,651 — Corporate bonds 152,925 — 152,925 — Commercial paper 34,922 — 34,922 — Equity securities 9,527 9,527 — — Total $ 1,598,793 $ 1,208,295 $ 390,498 $ — Liabilities: Contingent consideration $ 3,214 $ — $ — $ 3,214 Total $ 3,214 $ — $ — $ 3,214 December 31, 2019 Assets: Cash and cash equivalents $ 327,214 $ 311,245 $ 15,969 $ — Marketable securities: U.S. government agency securities and treasuries 635,936 — 635,936 — Certificates of deposit 960 — 960 — Corporate bonds 186,608 — 186,608 — Commercial paper 74,378 — 74,378 — Equity securities 12,870 12,870 — — Total $ 1,237,966 $ 324,115 $ 913,851 $ — Liabilities: Contingent consideration $ 7,977 $ — $ — $ 7,977 Total $ 7,977 $ — $ — $ 7,977 Cash and cash equivalents The Company considers all highly liquid securities with original final maturities of 90 days or less from the date of purchase to be cash equivalents. As of June 30, 2020, cash and cash equivalents comprise funds in cash and money market accounts. As of December 31, 2019, cash and cash equivalents comprise funds in cash, money market accounts, and commercial paper. Marketable securities Marketable securities classified as Level 2 within the valuation hierarchy generally consist of certificates of deposit, U.S. treasury securities and government agency securities, corporate bonds, and commercial paper. The Company estimates the fair values of these marketable securities by taking into consideration valuations obtained from third-party pricing sources. These pricing sources utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include market pricing based on real-time trade data for the same or similar securities, issuer credit spreads, benchmark yields, and other observable inputs. The Company validates the prices provided by its third-party pricing sources by understanding the models used, obtaining market values from other pricing sources and analyzing pricing data in certain instances. The amortized cost of available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to the earliest call date for premiums or to maturity for discounts. At June 30, 2020 and December 31, 2019, the balance in the Company’s accumulated other comprehensive loss includes activity related to the Company’s available-for-sale debt securities. There were no material realized gains or losses recognized on the sale or maturity of available-for-sale securities during the three and six months ended June 30, 2020 or 2019. Accrued interest receivable on the Company's available-for-sale debt securities totaled $1.7 million and $3.6 million as of June 30, 2020 and December 31, 2019, respectively. No accrued interest receivable was written off during the three and six months ended June 30, 2020 or 2019. The following table summarizes available-for-sale debt securities in a continuous unrealized loss position for less than and greater than twelve months, and for which an allowance for credit losses has not been recorded at June 30, 2020 and December 31, 2019 (in thousands): Less than 12 months 12 months or greater Total Description Fair value Unrealized losses Fair value Unrealized losses Fair value Unrealized losses June 30, 2020 U.S. government agency securities $ — $ — $ 10,498 $ (5) $ 10,498 $ (5) Total $ — $ — $ 10,498 $ (5) $ 10,498 $ (5) December 31, 2019 U.S. government agency securities $ 13,234 $ (3) $ 79,618 $ (45) $ 92,852 $ (48) Corporate bonds 53,983 (43) — — 53,983 (43) Total $ 67,217 $ (46) $ 79,618 $ (45) $ 146,835 $ (91) The Company determined that there was no material change in the credit risk of the above investments during the six months ended June 30, 2020. As such, an allowance for credit losses was not recognized. As of June 30, 2020, the Company does not intend to sell such securities and it is not more likely than not that the Company will be required to sell the securities before recovery of their amortized cost bases. The Company holds equity securities with an aggregate fair value of $9.5 million and $12.9 million as of June 30, 2020 and December 31, 2019, respectively, within short-term marketable securities on its condensed consolidated balance sheets. The Company has recorded an unrealized gain of $1.2 million and an unrealized loss of $3.3 million during the three and six months ended June 30, 2020, respectively, and unrealized losses of $3.1 million and $6.2 million during the three and six months ended June 30, 2019, respectively, related to its equity securities, which is included in other income (expense), net on the condensed consolidated statements of operations and comprehensive loss. Contingent consideration In connection with its prior acquisition of Precision Genome Engineering, Inc. (“Pregenen”), the Company may be required to pay future consideration that is contingent upon the achievement of specified development, regulatory approvals or sales-based milestone events. Contingent consideration is measured at fair value and is based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The valuation of contingent consideration uses assumptions the Company believes would be made by a market participant. The Company assesses these estimates on an on-going basis as additional data impacting the assumptions is obtained. Future changes in the fair value of contingent consideration related to updated assumptions and estimates are recognized within the condensed consolidated statements of operations and comprehensive loss. In the absence of new information, changes in fair value will reflect changing discount rates and the passage of time. Contingent consideration is included in accrued expenses and other current liabilities and other non-current liabilities on the condensed consolidated balance sheets. Please refer to Note 8, Commitments and contingencies, for further information. |
Property, plant and equipment,
Property, plant and equipment, net | 6 Months Ended |
Jun. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property, plant and equipment, net | Property, plant and equipment, net Property, plant and equipment, net, consists of the following (in thousands): As of June 30, 2020 As of December 31, 2019 Land $ 1,210 $ 1,210 Building 15,745 15,664 Computer equipment and software 6,837 6,947 Office equipment 7,611 7,599 Laboratory equipment 47,496 44,560 Leasehold improvements 34,019 33,788 Construction-in-progress 86,260 77,981 Total property, plant and equipment 199,178 187,749 Less accumulated depreciation and amortization (43,802) (36,573) Property, plant and equipment, net $ 155,376 $ 151,176 North Carolina manufacturing facility In November 2017, the Company acquired a manufacturing facility, which is in the process of construction, in Durham, North Carolina for the future manufacture of lentiviral vector for the Company’s gene therapies. As of June 30, 2020, a portion of the facility has been placed into service, and the remainder of the facility is still in process of construction. Construction-in-progress as of June 30, 2020 and December 31, 2019 includes $81.7 million and $74.2 million, respectively, related to the North Carolina manufacturing facility. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Accrued expenses and other current liabilities | Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following (in thousands): As of June 30, 2020 As of December 31, 2019 Employee compensation $ 39,018 $ 44,679 Manufacturing costs 33,171 23,126 Clinical and contract research organization costs 21,577 16,799 Collaboration research costs 7,886 27,142 Property, plant, and equipment 685 2,354 License and milestone fees 771 300 Professional fees 1,847 1,827 Other 30,657 25,329 Total accrued expenses and other current liabilities $ 135,612 $ 141,556 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2020 | |
Leases [Abstract] | |
Leases | Leases The Company leases certain office and laboratory space. Additionally, the Company has embedded leases at contract manufacturing organizations. Effective January 1, 2019, the Company adopted ASU 2016-02, Leases (Topic 842), (“ASC 842”), using the required modified retrospective approach and utilizing the effective date as the date of initial application. 60 Binney Street Lease In September 2015, the Company entered into a lease agreement for office and laboratory space located in a building (the “Building”) at 60 Binney Street, Cambridge, Massachusetts (the “60 Binney Street Lease”), which is now the Company’s corporate headquarters. Under the terms of the 60 Binney Street Lease, starting on October 1, 2016, the Company leases approximately 253,108 square feet of office and laboratory space at $72.50 per square foot per year, or $18.4 million per year in base rent, which is subject to scheduled annual rent increases of 1.75% plus certain operating expenses and taxes. The Company currently maintains a $13.8 million collateralized letter of credit and, subject to the terms of the lease and certain reduction requirements specified therein, including market capitalization requirements, this amount may decrease to $9.2 million over time. Pursuant to a work letter entered into in connection with the 60 Binney Street Lease, the landlord contributed an aggregate of $42.4 million toward the cost of construction and tenant improvements for the Building. The Company occupied the Building beginning in March 2017 and the 60 Binney Street Lease will continue until March 31, 2027. The Company has the option to extend the 60 Binney Street Lease for two successive five s. I n applying the ASC 842 transition guidance, the Company classified this lease as an operating lease and recorded a right-of-use asset and lease liability on the effective date. The Company is recognizing rent expense on a straight-line basis throughout the remaining term of the lease. 50 Binney Street Sublease In April 2019, the Company entered into a sublease agreement for office space located at 50 Binney Street in Cambridge, Massachusetts (the “50 Binney Street Sublease”) to supplement the Company’s corporate headquarters located at 60 Binney Street in Cambridge, Massachusetts. Under the terms of the 50 Binney Street Sublease, the Company will lease 267,278 square feet of office space for $99.95 per square foot, or $26.7 million per year in base rent subject to certain operating expenses, taxes and annual rent increases of approximately 3%. The lease will commence when the space is available for use by the Company, which is anticipated to be in the second half of 2021, and end on December 31, 2030, unless the Company earlier occupies the premises or other conditions specified in the 50 Binney Street Sublease occur. The sublessor has the right to postpone the commencement date until January 1, 2022 by providing not less than nine Seattle, Washington leases In July 2018, the Company entered into a lease agreement for office and laboratory space located in a portion of a building in Seattle, Washington. The lease was amended in October 2018 to increase the total rentable space to approximately 36,126 square feet at $54.00 per square foot in base rent per year, which is subject to scheduled annual rent increases of 2.5% plus certain operating expenses and taxes. The lease commenced on January 1, 2019, and the lease term will continue through January 31, 2027. The Company moved into the facility in June 2019. The Company determined the classification of this lease to be an operating lease and recorded a right-of-use asset and lease liability at lease commencement. In September 2019, the Company entered into a second amendment to the lease (the “Second Amendment”). The Second Amendment added approximately 22,188 square feet to the existing space and extended the lease term of the entire premises by 16 months, or until April 2028. Fixed monthly rent for the expanded space will be incurred at a rate of $62.80 per square foot per year beginning in January 2021, subject to annual increases of 2.5%. The Second Amendment includes a five Upon the execution of the Second Amendment, which was deemed to be a lease modification, the Company re-evaluated the assumptions made at the original lease commencement date. The Company determined the Second Amendment consists of two separate contracts under ASC 842. One contract is related to a new right-of-use for the expanded 22,188 square feet of space, which is to be accounted for as a new lease, and the other is related to the modification of term for the original 36,126 square feet of space. The Company recorded an additional right-of-use asset and lease liability upon lease commencement of the expanded space. The Company is recognizing rent expense on a straight-line basis through the remaining extended term of the respective leases. Embedded operating leases In June 2016, the Company entered into a manufacturing agreement for the future commercial production of the Company’s beti-cel, and eli-cel drug products with a contract manufacturing organization. Under this 12-year agreement, the contract manufacturing organization will complete the design, construction, validation, and process validation of the leased suites prior to anticipated commercial launch of the product candidates. During construction, the Company paid $12.0 million upon the achievement of certain contractual milestones and may pay up to $8.0 million in additional contractual milestones if the Company elects its option to lease additional suites. Construction was completed in March 2018 and beginning in April 2018, the Company pays $5.1 million per year in fixed suite fees, as well as certain fixed labor, raw materials, testing and shipping costs for manufacturing services, and may pay additional suite fees if it elects its option to reserve or lease additional suites. The Company may terminate this agreement at any time upon payment of a one-time termination fee and up to 24 months of fixed suite and labor fees. The Company determined that this agreement contains an embedded lease as the suites are designated for the Company’s exclusive use during the term of the agreement. The Company recorded a right-of-use asset and lease liability for this operating lease on the effective date of ASC 842 and is recognizing rent expense on a straight-line basis throughout the remaining term of the embedded lease. In November 2016, the Company entered into an agreement for clinical and commercial production of the Company’s ZYNTEGLO, LentiGlobin for SCD, and eli-cel drug products with a contract manufacturing organization at an existing facility. The Company concluded that this agreement contains an embedded operating lease as the clean rooms are designated for the Company’s exclusive use during the term of the agreement. The term of the agreement is five years with subsequent three estimated |
Commitments and contingencies
Commitments and contingencies | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies Contingent consideration related to business combinations In June 2014, the Company acquired Pregenen. The Company may be required to make up to $120.0 million in remaining future contingent cash payments to the former equityholders of Pregenen upon the achievement of certain clinical and commercial milestones related to the Pregenen technology, of which $20.1 million relates to clinical milestones and $99.9 million relates to commercial milestones. In accordance with accounting guidance for business combinations, contingent consideration liabilities are required to be recognized on the consolidated balance sheets at fair value. Estimating the fair value of contingent consideration requires the use of significant assumptions primarily relating to probabilities of successful achievement of certain clinical and commercial milestones, the expected timing in which these milestones will be achieved, and discount rates. The use of different assumptions could result in materially different estimates of fair value. Please refer to Note 4, Fair value measurements, for additional information. Other funding commitments The Company is party to various agreements, principally relating to licensed technology, that require future payments relating to milestones that may be met in subsequent periods or royalties on future sales of specified products, which includes the collaboration agreement entered into with Regeneron Pharmaceuticals, Inc. (“Regeneron”) in August 2018. Please refer to Note 9, Collaborative arrangements, for further information on the collaboration agreement with Regeneron. Additionally, the Company is party to various contracts with contract research organizations and contract manufacturers that generally provide for termination on notice, with the exact amounts in the event of termination to be based on the timing of the termination and the terms of the agreement. As compared to the contractual obligations and commitments as disclosed in the Company’s Annual Report on Form 10-K filed with the SEC on February 18, 2020, the Company’s future minimum purchase commitments as of the period ended June 30, 2020 decreased by $89.2 million primarily related to the Company's assignment of a contract manufacturing agreement to BMS; refer to Note 9, Collaborative arrangements , for discussion of the May 2020 amendments to the BMS arrangement for further discussion. The Company may be obligated to make future development, regulatory, and commercial milestone payments, and royalty payments on future sales of specified products associated with its collaboration and license agreements. Payments under these agreements generally become due and payable upon achievement of such milestones or sales. When the achievement of these milestones or sales have occurred, the corresponding amounts are recognized in the Company’s financial statements. As further discussed in Note 9, Collaborative arrangements , BMS assumed responsibility for amounts due to licensors as a result of any future ex-U.S. sales of ide-cel and bb21217. While there are no material legal proceedings the Company is aware of, the Company may become party to various claims and complaints arising in the ordinary course of business. The Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to the agreements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified party for losses suffered or incurred by the indemnified party, generally the Company’s business partners. The term of these indemnification agreements is generally perpetual any time after execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. Management does not believe that any ultimate liability resulting from any of these claims will have a material adverse effect on its results of operations, financial position, or liquidity. However, management cannot give any assurance regarding the ultimate outcome of any claims, and their resolution could be material to operating results for any particular period. The Company also indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company's request in such capacity, as permitted under Delaware law and in accordance with its certificate of incorporation and by-laws. The term of the indemnification period lasts as long as a director may be subject to any proceeding arising out of acts or omissions of such director or officer in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director and officer liability insurance. This insurance allows the transfer of risk associated with the Company's exposure and may enable it to recover a portion of any future amounts paid. The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, it has not recognized any liabilities relating to these obligations. |
Collaborative arrangements
Collaborative arrangements | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative arrangements | Collaborative arrangements To date, the Company’s revenue has been primarily generated from its collaboration arrangements with BMS, formerly Celgene prior to its acquisition by BMS in November 2019, and Regeneron Pharmaceuticals, Inc. ("Regeneron"), each as further described below. Bristol-Myers Squibb BMS Original Collaboration Agreement In March 2013, the Company entered into a Master Collaboration Agreement (the “BMS Collaboration Agreement”) with Celgene (now BMS following its acquisition of Celgene in November 2019) to discover, develop and commercialize potentially disease-altering gene therapies in oncology. The collaboration is focused on applying gene therapy technology to genetically modify a patient’s own T cells, known as chimeric antigen receptor, or CAR T cells, to target and destroy cancer cells. Additionally, in March 2013, the Company entered into a Platform Technology Sublicense Agreement (the “Sublicense Agreement”) with BMS pursuant to which the Company obtained a sublicense to certain intellectual property from BMS, originating under BMS’s license from Baylor College of Medicine, for use in the collaboration. Under the terms of the BMS Collaboration Agreement, the Company received an up-front, non-refundable, non-creditable payment of $75.0 million. The Company was responsible for conducting discovery, research and development activities through completion of phase 1 clinical studies, if any, during the initial term of the BMS Collaboration Agreement, or three years. BMS Amended Collaboration Agreement In June 2015, the Company and BMS amended and restated the BMS Collaboration Agreement (the “Amended BMS Collaboration Agreement”). Under the Amended BMS Collaboration Agreement, the parties narrowed the focus of the collaboration to exclusively work on anti- B-cell maturation antigen (“BCMA”) product candidates for a new three On a product candidate-by-product candidate basis, up through a specified period following enrollment of the first patient in an initial phase 1 clinical study for such product candidate, the Company had granted BMS an option to obtain an exclusive worldwide license to develop and commercialize such product. Following BMS’s license of each product candidate, the Company is entitled to elect to co-develop and co-promote each product candidate in the U.S. BMS Ide-cel License Agreement In February 2016, BMS exercised its option to obtain an exclusive worldwide license to develop and commercialize ide-cel, the first product candidate under the Amended BMS Collaboration Agreement, pursuant to an executed license agreement (“Ide-cel License Agreement”) entered into by the parties in February 2016 and paid to the Company the associated $10.0 million option fee. Pursuant to the Ide-cel License Agreement, BMS was responsible for development and related funding of ide-cel after the substantial completion of the phase 1 clinical trial. The Company was responsible for the manufacture of vector and associated payload throughout development and upon BMS’s request, throughout commercialization, the costs of which were reimbursable by BMS in accordance with the terms of the Amended and Restated Co-Development, Co-Promote and Profit Share Agreement, as further described below. BMS was responsible for the manufacture of drug product throughout development and commercialization. Under the Ide-cel License Agreement, the Company was eligible to receive U.S. milestones of up to $85.0 million for the first indication to be addressed by ide-cel and royalties for U.S. sales of ide-cel. Additionally, the Company was eligible to receive ex-U.S. milestones of up to $55.0 million and royalties for ex-U.S. sales of ide-cel. BMS Ide-cel Co-Development, Co-Promote and Profit Share Agreement In March 2018, the Company elected to co-develop and co-promote ide-cel within the U.S. pursuant to the execution of the Amended and Restated Co-Development, Co-Promote and Profit Share Agreement (“Ide-cel CCPS”), which replaced the Ide-cel License Agreement. As a result of executing the Ide-cel CCPS, the responsibilities of the parties remained unchanged from those under the Ide-cel License Agreement, however, the Company will share equally in all profits and losses relating to developing, commercializing and manufacturing ide-cel within the U.S. and has the right to participate in the development and promotion of ide-cel in the U.S. BMS is responsible for the costs incurred to manufacture vector and associated payload for use outside of the U.S., plus a mark-up. As a result of electing to co-develop and co-promote ide-cel within the U.S., the milestones and royalties payable under the Ide-cel License Agreement were adjusted. Under the Ide-cel CCPS, the Company was eligible to receive a $10.0 million milestone related to the development of ide-cel in the U.S. and, for the first indication to be addressed by ide-cel, ex-U.S. regulatory and commercial milestones of up to $60.0 million. Additionally, the Company was eligible to receive royalties for ex-U.S. sales of ide-cel, but not for U.S. sales of ide-cel. Under the Ide-cel CCPS, the $10.0 million development milestone was achieved in the second quarter of 2019 and subsequently paid by BMS. In May 2020, the First Amendment to the Amended and Restated Co-Development, Co-Promote and Profit Share Agreement (as amended, the "Amended Ide-cel CCPS") was executed, which amended the Ide-cel CCPS. Under the Amended Ide-cel CCPS, the parties will continue to share equally in all profits and losses relating to developing, commercializing and manufacturing ide-cel within the U.S. Under the Amended Ide-cel CCPS and the Amended bb21217 License Agreement, described further below, BMS was relieved of its obligations to pay the Company for future ex-U.S. milestones and royalties on ex-U.S. sales for each of ide-cel and bb21217 in exchange for an up-front, non-refundable, non-creditable payment of $200.0 million, which represents the aggregate of the probability-weighted, net present value of the future ex-U.S. milestones and royalties on ex-U.S. sales for each of ide-cel and bb21217. In connection with these amendments, BMS assumed a contract manufacturing agreement relating to ide-cel lentiviral vector. Over time, BMS will assume responsibility for manufacturing ide-cel lentiviral vector for use outside of the U.S., with bluebird retaining responsibility for manufacturing ide-cel lentiviral vector for use within the U.S. during development and, upon request, throughout commercialization. In addition, under the Amended Ide-cel CCPS and the Amended bb21217 License Agreement, described further below, the parties are released from future exclusivity related to BCMA-directed T cell therapies. There are no remaining milestones or royalties under the Amended Ide-cel CCPS. BMS bb21217 License Agreement In September 2017, BMS exercised its option to obtain an exclusive worldwide license to develop and commercialize bb21217, the second product candidate under the Amended BMS Collaboration Agreement, pursuant to an executed license agreement (“bb21217 License Agreement”) entered into by the parties in September 2017 and paid the Company an option fee of $15.0 million. Pursuant to the bb21217 License Agreement, BMS is responsible for development and related funding of bb21217 after the substantial completion of the ongoing phase 1 clinical trial. In 2019, the parties amended the protocol for the ongoing phase 1 clinical trial to enroll additional patients for which the Company will be reimbursed based upon an agreed-upon amount per patient. Under the bb21217 License Agreement, the Company is eligible to receive U.S. milestones of up to $85.0 million for the first indication to be addressed by bb21217 and royalties for U.S. sales of bb21217. Additionally, the Company was eligible to receive ex-U.S. milestones of up to $55.0 million and royalties for ex-U.S. sales of bb21217. In May 2020, the Second Amended and Restated License Agreement ("Amended bb21217 License Agreement") was executed, which replaced the bb21217 License Agreement. Under the Amended bb21217 License Agreement, over time, BMS will assume responsibility for manufacturing bb21217 lentiviral vector for use outside of the U.S., with bluebird retaining responsibility for manufacturing bb21217 lentiviral vector for use within the U.S. during development and, upon request, throughout commercialization. Under the Amended bb21217 License Agreement, expenses incurred by the Company associated with these activities are fully reimbursable by BMS at cost plus a mark-up. Throughout both development and commercialization, BMS is responsible for the manufacture of drug product. There are no remaining milestones and royalties related to the ex-U.S. development or commercialization of bb21217 following execution of the Amended bb21217 License Agreement. The Company currently expects it will exercise its option to co-develop and co-promote bb21217 within the U.S. The Company’s election to co-develop and co-promote bb21217 must be made by the substantial completion of the on-going phase 1 clinical trial of bb21217. If elected, the Company expects the responsibilities of the parties to remain largely unchanged, however, the Company expects it will share equally in all profits and losses relating to developing, commercializing and manufacturing bb21217 within the U.S. and to have the right to participate in the development and promotion of bb21217 in the U.S. Under this scenario, the U.S. milestones and royalties payable under the bb21217 License Agreement would be adjusted and the Company would be eligible to receive a $10.0 million development milestone payment related to the development of bb21217 within the U.S. The Company would not be eligible for royalties on U.S. sales of bb21217 under this scenario. In the event the Company does not exercise its option to co-develop and co-promote bb21217, the Company will receive an additional fee in the amount of $10.0 million. Under this scenario, there would be no change to the U.S. milestones and royalties for U.S. sales of bb21217, as previously described above, for which the Company would be eligible to receive. Accounting Analysis – Amended Ide-cel CCPS and Amended bb21217 License Agreement In accordance with the Company’s accounting policies related to variable consideration, as further described in the Company’s Annual Report on Form 10-K filed with the SEC on February 18, 2020, if an arrangement includes variable consideration, including milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price of an arrangement. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied. Prior to the May 2020 amendments, the Company had constrained all variable consideration related to the remaining ex-U.S. milestones and royalties for ex-U.S. sales under the Ide-cel CCPS and bb21217 License Agreement. As a result of the May 2020 amendments, the uncertainty associated with the previously constrained variable consideration for future ex-U.S. milestones and royalties on ex-U.S. sales for each of ide-cel and bb21217 was resolved in exchange for an up-front, non-refundable, non-creditable payment of $200.0 million. While the Ide-cel CCPS and bb21217 License Agreement were historically accounted for as separate contracts, the May 2020 amendments to each agreement were negotiated as a package with a single commercial objective and, as such, the Amended Ide-cel CCPS and Amended bb21217 License Agreement were combined for accounting purposes and treated as a single arrangement. At the time of the May 2020 amendments, there was one remaining performance obligation under each of the Ide-cel CCPS and bb21217 License Agreement, neither of which were fully satisfied: a combined performance obligation of the ide-cel license and ide-cel vector manufacturing through development; and a combined performance obligation of the bb21217 license and bb21217 vector manufacturing through development. Subsequent to the May 2020 amendments, the Company concluded the two performance obligations are distinct from each other as BMS can benefit from each license and associated manufacturing services separately and the respective licenses and manufacturing services do not modify one another and are not interdependent. Accordingly, the Company will continue to account for each performance obligation separately. The Company allocated the $200.0 million up-front payment received in connection with the May 2020 amendments to the remaining performance obligations described above based on the general allocation principles of Topic 606. In applying these principles, the Company considered the $200.0 million up-front payment is representative of previously constrained variable consideration that has been changed and the related uncertainties resolved by the May 2020 amendments. Moreover, the Company considered that a portion of the $200.0 million was specifically attributable to each remaining performance obligation as the amount represents the aggregate of the probability-weighted, net present value of the future ex-U.S. milestones and royalties on ex-U.S. sales for each of ide-cel and bb21217 and that each respective portion therefore (i) relates specifically to the Company's satisfaction of each of its remaining performance obligations and (ii) is representative of the amount of consideration the Company expects to be entitled to in exchange for satisfying the respective performance obligations. As such, the Company concluded that the portion of the $200.0 million up-front payment specifically attributable to each of ide-cel and bb21217 should be allocated to each respective performance obligation pursuant to the variable consideration allocation exception. The Amended Ide-cel CCPS and Amended bb21217 License Agreement represent a contract modification to an existing contract under Topic 606 given the May 2020 amendments resulted in a reduction in scope of the Company's responsibilities under each performance obligation described above. Specifically, the May 2020 amendments reduced the scope of the Company's obligation to provide ex-U.S. vector manufacturing services through development for both ide-cel and bb21217 as those activities will transition to BMS over time. In addition, the May 2020 amendments resulted in a change in the overall transaction price under the arrangement. The May 2020 amendments did not include any additional promised goods and services. The remaining goods and services to be provided in order to fully satisfy each performance obligation described above are not distinct from those previously provided with respect to each performance obligation. Therefore, for each performance obligation, the remaining goods and services are part of a single performance obligation that is partially satisfied at the date of the contract modification. Accordingly, the effect that the contract modification had on the transaction price and the measure of progress toward complete satisfaction of each respective performance obligation has been recognized on a cumulative catch-up basis. The accounting for any previously satisfied performance obligations as of the contract modification date are not affected by the modification. Ide-cel transaction price The following tables summarize the total transaction price, the allocation of the total transaction price to the identified performance obligations under the arrangement (including those performance obligations that were completed as of the May 2020 contract modification date), and the amount of the transaction price unsatisfied as of June 30, 2020 (in thousands): Ide-cel transaction price as of June 30, Up-front non-refundable payments, option fee and milestone payments received prior to May 2020 $ 120,000 Allocated portion of the up-front non-refundable payment received in connection with the Amended Ide-cel CCPS and bb21217 License Agreement (2) 184,029 Estimated variable consideration (3) 83,083 $ 387,112 (1) Composed of all up-front payments and option fee and milestone payments received under the BMS Collaboration Agreement, Amended BMS Collaboration Agreement, Ide-cel License Agreement, and Ide-cel CCPS. This consideration was allocated to the performance obligations under the Ide-cel CCPS based on a relative standalone selling price (“SSP”) basis. The Company estimated the SSP of the ide-cel license after considering potential future cash flows under the license. The Company then discounted these probability-weighted cash flows to their present value. The Company estimated the SSP of each of the ide-cel research and development services and ide-cel manufacturing services to be provided based on the Company’s estimated cost of providing the services plus an applicable profit margin commensurate with observable market data for similar services. (2) This represents the portion of the $200.0 million up-front payment received under the Amended Ide-cel CCPS and Amended bb21217 License Agreement which was allocated to ide-cel. (3) Estimated variable consideration represents the estimated reimbursement from BMS for the manufacture of vectors and associated payload through development. Allocation of Transaction price unsatisfied as of June 30, 2020 Ide-cel research and development services $ 40,912 $ — Ide-cel license and manufacturing services 346,200 5,151 $ 387,112 $ 5,151 Ide-cel research and development services The Company satisfied this performance obligation as the research and development services were performed. The Company determined that the period of performance of the research and development services was three years through projected initial phase 1 clinical study substantial completion, or through May 2018. The research and development performance obligation was satisfied prior to the May 2020 amendments and, as a result, the accounting for this previously satisfied performance obligation was not affected by the modification. The Company recognized revenue related to ide-cel research and development services of $0.0 million for the three and six months ended June 30, 2020 and $2.5 million and $2.3 million for the three and six months ended June 30, 2019, respectively. Ide-cel license and manufacturing services The Company accounts for its vector manufacturing services for development in the U.S. and BMS’s U.S. development efforts within the scope of ASC 808, Collaborative Arrangements ("ASC 808") given that both parties are active participants in the activities and both parties are exposed to significant risks and rewards dependent on the commercial success of the activities. The Company recognizes revenue for its U.S. manufacturing services by analogy to Topic 606. The portion of BMS’s U.S. development costs that the Company is responsible for are recognized as a reduction to its collaborative arrangement revenues, or, if in excess of such revenues in a given quarter, the excess is recorded as research and development expense. The Company recognizes revenue associated with the combined performance obligation using the proportional performance method, as the Company will satisfy this performance obligation as the manufacturing services are performed through development. In using this method, the Company estimated its development plan for ide-cel, including expected demand from BMS, and the costs associated with the manufacture of vectors and associated payload for incorporation into ide-cel. On a quarterly basis, the Company determines the proportion of effort incurred as a percentage of total effort it expects to expend. This ratio is applied to the transaction price, which includes variable consideration, allocated to the combined performance obligation consisting of the ide-cel license and manufacturing services. Management has applied significant judgment in the process of developing its budget estimates and any changes to these estimates will be recognized in the period in which they change as a cumulative catch-up. The following table summarizes the net collaborative arrangement revenue recognized or expense incurred for the joint ide-cel development efforts in the U.S. under ASC 808 related to the combined performance obligation for the license and vector manufacturing of ide-cel in the U.S. for the three and six months ended June 30, 2020, and 2019 (in thousands): For the three months ended June 30, For the six months ended June 30, 2020 2019 2020 2019 ASC 808 ide-cel license and manufacturing revenue - U.S. (1) $ 108,196 $ — $ 108,196 $ — ASC 808 ide-cel research and development expense - U.S. (1) $ — $ (1,065) $ (5,080) $ (4,309) (1) As noted above, the calculation of collaborative arrangement revenue or research and development expense to be recognized for joint ide-cel development efforts in the U.S. is performed on a quarterly basis. The calculation is independent of previous activity, which may result in fluctuations between revenue and expense recognition period over period, depending on the varying extent of effort performed by each party during the period. Revenue related to the combined unit of accounting for the ex-U.S. license and vector manufacturing services is accounted for in accordance with Topic 606. The following table summarizes the revenue recognized related to the combined unit of accounting for the ide-cel ex-U.S. license and vector manufacturing services for the three and six months ended June 30, 2020, and 2019 (in thousands): For the three months ended June 30, For the six months ended June 30, 2020 2019 2020 2019 ASC 606 ide-cel license and manufacturing revenue - ex-U.S. $ 73,850 $ 7,899 $ 87,820 $ 16,963 As of June 30, 2020, the aggregate amount of the transaction price allocated to the combined performance obligation, which consists of the ide-cel license and manufacturing services, that is unsatisfied, or partially unsatisfied, is $5.2 million, which the Company expects to recognize as revenue as manufacturing services are provided through the remaining development period which is estimated to be completed following the successful transition of the contract manufacturing agreement relating to ide-cel lentiviral vector. As of June 30, 2020 and December 31, 2019, the Company had $3.9 million and $8.5 million, respectively, of deferred revenue associated with the combined performance obligation consisting of the ide-cel license and manufacturing services. bb21217 transaction price The following tables summarize the total transaction price, the allocation of the total transaction price to the identified performance obligations under the arrangement (including those performance obligations that were completed as of the May 2020 contract modification date), and the amount of the transaction price unsatisfied as of June 30, 2020 (in thousands): bb21217 transaction price as of June 30, 2020 Up-front non-refundable payment received prior to May 2020 contract modification (1) $ 15,000 Allocated portion of the up-front non-refundable payment received in connection with the Amended Ide-cel CCPS and bb21217 License Agreement (2) 15,971 Estimated variable consideration (3) 1,803 $ 32,774 (1) Composed of the up-front non-refundable payment received under the bb21217 License Agreement. This consideration was allocated to the performance obligations under the bb21217 License Agreement based on a relative SSP basis. The Company estimated the SSP of the bb21217 license after considering potential future cash flows under the license. The Company then discounted these probability-weighted cash flows to their present value. The Company estimated the SSP of each of the bb21217 research and development services and bb21217 manufacturing services to be provided based on the Company’s estimated cost of providing the services plus an applicable profit margin commensurate with observable market data for similar services. (2) This represents the portion of the $200.0 million up-front payment received under the Amended Ide-cel CCPS and Amended bb21217 License Agreement which was allocated to bb21217. (3) Estimated variable consideration represents the estimated reimbursement from BMS for the manufacture of vectors and associated payload through development. Allocation of transaction Transaction price unsatisfied as of June 30, 2020 bb21217 research and development services $ 5,444 $ — bb21217 license and manufacturing services 27,330 27,330 $ 32,774 $ 27,330 All of the remaining development, regulatory, and commercial milestones under the Amended bb21217 License Agreement are related to U.S. development, regulatory and commercialization activities and are fully constrained and are therefore excluded from the transaction price. As part of its evaluation of the constraint, the Company considered numerous factors, including the fact that achievement of the milestones is outside the control of the Company and contingent upon the future success of its clinical trials, the licensee’s efforts, or the receipt of regulatory approval. Any consideration related to U.S. sales-based milestones (including royalties) will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license granted to BMS and therefore are recognized at the later of when the performance obligation is satisfied, or the related sales occur. The Company re-evaluates the transaction price, including its estimated variable consideration included in the transaction price and all constrained amounts, each reporting period and as uncertain events are resolved or other changes in circumstances occur. bb21217 research and development services The Company satisfied this performance obligation as the research and development services were performed. The Company determined that the period of performance of the research and development services was two years through projected substantial completion of the initial phase 1 clinical study, or through September 2019. The research and development performance obligation was satisfied prior to the May 2020 amendments, and as a result, the accounting for this previously satisfied performance obligation was not affected by the modification. As part of performing its initial obligation to complete a phase 1 trial as originally contemplated, the Company recognized revenue of $0.0 million for the three and six months ended June 30, 2020 and $0.7 million and $1.4 million for the three and six months ended June 30, 2019, respectively. The agreement to expand the bb21217 phase 1 trial that occurred in 2019 was previously treated as a separate contract for accounting purposes, because the trial expansion was for the addition of a promised good or service that is distinct and the associated consideration reflected the standalone selling price of the additional promised good or service. This contract was not affected by the May 2020 amendments and, accordingly, the accounting for this agreement was not impacted by the May 2020 amendments. The transaction price associated with these additional patients consists of variable consideration and is based upon an agreed-upon amount per patient which will be recognized as revenue as the patients are treated. The Company began fulfilling the performance obligation in the fourth quarter of 2019 and it remained partially unsatisfied as of June 30, 2020. In connection with treating additional patients in the phase 1 trial, the Company recognized revenue of $4.0 million and $6.4 million for the three and six months ended June 30, 2020, respectively. bb21217 license and manufacturing services The Company will satisfy its performance obligation related to the manufacture of vectors and associated payload for incorporation into bb21217 through development as the bb21217 manufacturing services are performed. As of June 30, 2020, the manufacturing services for bb21217 had not yet commenced. Therefore, no amounts have been recognized for the combined performance obligation in the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2020, and 2019. The aggregate amount of the transaction price allocated to the combined performance obligation, which consists of the bb21217 license and manufacturing services, is $27.3 million. The Company does not expect that recognition will begin in the next twelve months and has therefore classified deferred revenue associated with the combined performance obligation as deferred revenue, net of current portion on its consolidated balance sheets. The Company had $25.8 million and $9.8 million of remaining deferred revenue as of June 30, 2020 and December 31, 2019, respectively, associated with the combined performance obligation consisting of the bb21217 license and manufacturing services. Contract assets and liabilities – ide-cel and bb21217 The Company receives payments from its collaborative partners based on billing schedules established in each contract. Up-front payments and fees are recorded as deferred revenue upon receipt or when due until such time as the Company satisfies its performance obligations under these arrangements. A contract asset is a conditional right to consideration in exchange for goods or services that the Company has transferred to a customer. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The following table presents changes in the balances of the Company’s BMS receivables and contract liabilities during the six months ended June 30, 2020 (in thousands): Balance at December 31, Additions Deductions Balance at Receivables $ 400 $ 6,400 $ (2,800) $ 4,000 Contract liabilities: Deferred revenue $ 18,265 $ 200,000 $ (188,588) $ 29,677 The change in the receivables balance for the six months ended June 30, 2020 is primarily driven by amounts owed to the Company for bb21217 research and development services provided in the first half of 2020 (expanded phase 1 clinical trial), offset by amounts collected from BMS in the period. The increase in deferred revenue during the six months ended June 30, 2020 is driven by the $200.0 million consideration received in connection with the May 2020 amendments, offset by revenue recognized in the year-to-date period related to the combined unit of accounting for ide-cel license and vector manufacturing services. A total of $188.6 million was released from deferred revenue during the year-to-date period, of which $169.2 million is related to a cumulative catch-up adjustment to revenue recorded in connection with the May 2020 contract modification described further above. As of December 31, 2019, the Company had $8.5 million of deferred revenue associated with the combined performance obligation consisting of the ide-cel license and manufacturing services, of which $7.3 million was released during the six months ended June 30, 2020. Regeneron Regeneron Collaboration Agreement In August 2018, the Company entered into a Collaboration Agreement (the “Regeneron Collaboration Agreement”) with Regeneron pursuant to which the parties will apply their respective technology platforms to the discovery, development, and commercialization of novel immune cell therapies for cancer. In August 2018, following the completion of required regulatory reviews, the Regeneron Collaboration Agreement became effective. Under the terms of the agreement, the parties will leverage Regeneron’s proprietary platform technologies for the discovery and characterization of fully human antibodies, as well as T cell receptors directed against tumor-specific proteins and peptides and the Company will contribute its field-leading expertise in gene therapy. In accordance with the Regeneron Collaboration Agreement, the parties jointly selected six initial targets and intend to equally share the costs of research up to the point of submitting an IND application for a potential gene therapy product directed to a particular target. Additional targets may be selected to add to or replace any of the initial targets during the five Regeneron will accrue a certain number of option |
Equity
Equity | 6 Months Ended |
Jun. 30, 2020 | |
Equity [Abstract] | |
Equity | EquityIn May 2020, the Company sold 10.5 million shares of common stock (inclusive of shares sold pursuant to an option granted to the underwriters in connection with the offering) through an underwritten public offering at a price of $55.00 per share for aggregate net proceeds of $541.5 million. |
Stock-based compensation
Stock-based compensation | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based compensation | Stock-based compensation In January 2020 and 2019, the number of shares of common stock available for issuance under the 2013 Stock Option and Incentive Plan (“2013 Plan”) was increased by approximately 2.2 million and 2.2 million shares, respectively, as a result of the automatic increase provision of the 2013 Plan. As of June 30, 2020, the total number of shares of common stock available for issuance under the 2013 Plan was approximately 2.4 million. Stock-based compensation expense The Company recognized stock-based compensation expense totaling $48.5 million and $84.8 million for the three and six months ended June 30, 2020, respectively. The Company recognized stock-based compensation expense totaling $55.1 million and $87.5 million for the three and six months ended June 30, 2019, respectively. Stock-based compensation expense by award type included within the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): For the three months ended June 30, For the six months ended June 30, 2020 2019 2020 2019 Stock options $ 26,073 $ 24,800 $ 50,513 $ 47,983 Restricted stock units 14,143 30,012 25,996 38,893 Employee stock purchase plan and other 8,313 299 8,313 576 $ 48,529 $ 55,111 $ 84,822 $ 87,452 Stock-based compensation expense by classification included within the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): For the three months ended June 30, For the six months ended June 30, 2020 2019 2020 2019 Research and development $ 23,098 $ 29,694 $ 39,367 $ 45,210 Selling, general and administrative 25,431 25,417 45,455 42,242 $ 48,529 $ 55,111 $ 84,822 $ 87,452 As of June 30, 2020, the Company had approximately $332.0 million of unrecognized stock-based compensation expense, which is expected to be recognized over a weighted-average period of approximately 2.5 years. Stock option activity The following table summarizes the stock option activity under the Company’s equity award plans: Shares (in thousands) Weighted- average exercise price per share Outstanding at December 31, 2019 5,483 $ 116.30 Granted 1,306 $ 72.50 Exercised (27) $ 40.91 Canceled, forfeited, or expired (296) $ 135.10 Outstanding at June 30, 2020 6,466 $ 106.90 Exercisable at June 30, 2020 3,442 $ 102.07 Vested and expected to vest at June 30, 2020 6,466 $ 106.90 During the six months ended June 30, 2020, less than 0.1 million stock options were exercised, resulting in total proceeds to the Company of $1.1 million. Restricted stock unit activity The following table summarizes the restricted stock unit activity under the Company’s equity award plans: Shares Weighted- Unvested balance at December 31, 2019 1,127 $ 146.10 Granted 879 $ 72.59 Vested (318) $ 143.73 Forfeited (95) $ 132.84 Unvested balance at June 30, 2020 1,593 $ 106.81 Employee stock purchase plan In June 2013, the Company adopted its 2013 Employee Stock Purchase Plan (“2013 ESPP”), which authorized the initial issuance of up to a total of 0.2 million shares of the Company’s common stock to participating employees. During each of the six months ended June 30, 2020 and 2019, less than 0.1 million shares of common stock were issued under the 2013 ESPP. |
Net loss per share
Net loss per share | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
Net loss per share | Net loss per share The following common stock equivalents were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect (in thousands): For the three and six months ended June 30, 2020 2019 Outstanding stock options 6,466 5,393 Restricted stock units 1,593 1,103 ESPP shares and other 323 15 8,382 6,511 |
Basis of presentation, princi_2
Basis of presentation, principles of consolidation and significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The accompanying condensed consolidated financial statements are unaudited and have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) as found in the Accounting Standards Codification ("ASC") and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These condensed consolidated financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position and results of operations for the interim periods ended June 30, 2020 and 2019. |
Consolidation | The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to GAAP. The Company views its operations and manages its business in one operating segment. |
Marketable securities | Marketable securities Effective January 1, 2020, the Company adopted ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements ("ASU 2016-13" or "ASC 326"), using the effective date method. As the Company had never recorded any other-than-temporary-impairment adjustments to its available-for-sale debt securities prior to the effective date, no transition provisions are applicable to the Company. The Company assesses its available-for-sale debt securities under the available-for-sale debt security impairment model in ASC 326 as of each reporting date in order to determine if a portion of any decline in fair value below carrying value recognized on its available-for-sale debt securities is the result of a credit loss. The Company records credit losses in the condensed consolidated statements of operations and comprehensive loss as credit loss expense within other expense, net, which is limited to the difference between the fair value and the amortized cost of the security. To date, the Company has not recorded any credit losses on its available-for-sale debt securities. Accrued interest receivable related to the Company's available-for-sale debt securities is presented within receivables and other current assets on the Company's condensed consolidated balance sheets. The Company has elected the practical expedient available to exclude accrued interest receivable from both the fair value and the amortized cost basis of available-for-sale debt securities for the purposes of identifying and measuring any impairment. The Company writes off accrued interest receivable once it has determined that the asset is not realizable. Any write offs of accrued interest receivable are recorded by reversing interest income, recognizing credit loss expense, or a combination of both. To date, the Company has not written off any accrued interest receivables associated with its marketable securities. |
Stock-based compensation | Stock-based compensation The Company estimates the fair value of its option awards using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate, and (iv) expected dividends. Effective January 1, 2020, the Company eliminated the use of a representative peer group and uses only its own historical volatility data in its estimate of expected volatility given that there is now a sufficient amount of historical information regarding the volatility of its own stock price. |
Use of estimates | Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements. Estimates are used in the following areas, among others: future undiscounted cash flows and subsequent fair value estimates used to assess potential and measure any impairment of long-lived assets, including goodwill and intangible assets, and the measurement of right-of-use assets and lease liabilities, contingent consideration, stock-based compensation expense, accrued expenses, revenue, income taxes, and the assessment of the Company's ability to fund its operations for at least the next twelve months from the date of issuance of these financial statements. |
Recent accounting pronouncements | Recent accounting pronouncements Recently adopted ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements, ASU No. 2019-5 Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief, ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments - Credit Losses In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements . The new standard, as amended, requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. The targeted transition relief standard allows filers an option to irrevocably elect the fair value option of ASC 825-10, Financial Instruments-Overall , applied on an instrument-by-instrument basis for eligible instruments. The Company adopted this standard on January 1, 2020 on a prospective basis and the adoption did not have a material impact on its financial position and results of operations. ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement. The new standard removes certain disclosures, modifies certain disclosures, and adds additional disclosures related to fair value measurement. The Company adopted this standard on January 1, 2020, and it did not have a material impact on its financial position and results of operations upon adoption. ASU No. 2018-15, Intangibles-Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . The amendments in this update align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). The accounting for the service element of a hosting arrangement that is a service contract is not affected by the amendments in this update. The Company adopted this standard on a prospective basis as of January 1, 2020, and it did not have a material impact on its financial position and results of operations upon adoption. ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 , (“ASU 2018-18”). The amendments in this update clarify that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606 , Revenue from Contracts with Customers (“Topic 606” or "ASC 606") when the counter party is a customer in the context of a unit of account. ASU 2018-18 also precludes companies from presenting transactions with collaborative partners that are outside the scope of Topic 606 together with revenue within the scope of Topic 606. The Company adopted this standard on a retrospective basis on January 1, 2020. As a result, revenue for prior periods are presented in accordance with the new standard. Prior to the adoption of ASU 2018-18, the Company presented all revenue recognized under its collaborative arrangements as collaboration revenue on its condensed consolidated statement of operations and comprehensive loss. However, as the Company recognizes revenue under its collaborative arrangements both within and outside the scope of Topic 606, the Company has revised its presentation of revenue on its condensed consolidated statement of operations and comprehensive loss as follows: service revenue includes revenue from collaborative partners recognized within the scope of Topic 606 and collaborative arrangement revenue includes revenue from collaborative partners recognized outside the scope of Topic 606. The disaggregation of revenue recognized under Topic 606 and outside of Topic 606 had previously otherwise been disclosed in the Notes to Condensed Consolidated Financial Statements. ASU No. 2019-4, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments In April 2019, the FASB issued ASU 2019-4, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments. This update provides clarifications for three topics related to financial instruments accounting, some of which apply to the Company. The Company adopted this standard on January 1, 2020 on a prospective basis, and it did not have a material impact on its financial position and results of operations upon adoption. Not yet adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ("ASU 2019-12"), which is intended to simplify the accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The new standard will be effective beginning January 1, 2021. The Company is currently evaluating the potential impact ASU 2019-12 may have on its financial position and results of operations upon adoption. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Marketable Securities Held | The following table summarizes the marketable securities held at June 30, 2020 and December 31, 2019 (in thousands): Description Amortized cost / Cost Unrealized gains Unrealized losses Fair value June 30, 2020 U.S. government agency securities and treasuries $ 201,362 $ 1,294 $ (5) $ 202,651 Corporate bonds 151,305 1,620 — 152,925 Commercial paper 34,922 — — 34,922 Equity securities 20,017 — (10,490) 9,527 Total $ 407,606 $ 2,914 $ (10,495) $ 400,025 December 31, 2019 U.S. government agency securities and treasuries $ 633,970 $ 2,014 $ (48) $ 635,936 Certificates of deposit 960 — — 960 Corporate bonds 185,827 824 (43) 186,608 Commercial paper 74,378 — — 74,378 Equity securities 20,017 — (7,147) 12,870 Total $ 915,152 $ 2,838 $ (7,238) $ 910,752 |
Fair value measurements (Tables
Fair value measurements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Recorded Amount of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table sets forth the Company’s assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2020 and December 31, 2019 (in thousands): Description Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) June 30, 2020 Assets: Cash and cash equivalents $ 1,198,768 $ 1,198,768 $ — $ — Marketable securities: U.S. government agency securities and treasuries 202,651 — 202,651 — Corporate bonds 152,925 — 152,925 — Commercial paper 34,922 — 34,922 — Equity securities 9,527 9,527 — — Total $ 1,598,793 $ 1,208,295 $ 390,498 $ — Liabilities: Contingent consideration $ 3,214 $ — $ — $ 3,214 Total $ 3,214 $ — $ — $ 3,214 December 31, 2019 Assets: Cash and cash equivalents $ 327,214 $ 311,245 $ 15,969 $ — Marketable securities: U.S. government agency securities and treasuries 635,936 — 635,936 — Certificates of deposit 960 — 960 — Corporate bonds 186,608 — 186,608 — Commercial paper 74,378 — 74,378 — Equity securities 12,870 12,870 — — Total $ 1,237,966 $ 324,115 $ 913,851 $ — Liabilities: Contingent consideration $ 7,977 $ — $ — $ 7,977 Total $ 7,977 $ — $ — $ 7,977 |
Debt Securities, Available-for-sale, Unrealized Loss Position, Fair Value | The following table summarizes available-for-sale debt securities in a continuous unrealized loss position for less than and greater than twelve months, and for which an allowance for credit losses has not been recorded at June 30, 2020 and December 31, 2019 (in thousands): Less than 12 months 12 months or greater Total Description Fair value Unrealized losses Fair value Unrealized losses Fair value Unrealized losses June 30, 2020 U.S. government agency securities $ — $ — $ 10,498 $ (5) $ 10,498 $ (5) Total $ — $ — $ 10,498 $ (5) $ 10,498 $ (5) December 31, 2019 U.S. government agency securities $ 13,234 $ (3) $ 79,618 $ (45) $ 92,852 $ (48) Corporate bonds 53,983 (43) — — 53,983 (43) Total $ 67,217 $ (46) $ 79,618 $ (45) $ 146,835 $ (91) |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property, Plant and Equipment Net | Property, plant and equipment, net, consists of the following (in thousands): As of June 30, 2020 As of December 31, 2019 Land $ 1,210 $ 1,210 Building 15,745 15,664 Computer equipment and software 6,837 6,947 Office equipment 7,611 7,599 Laboratory equipment 47,496 44,560 Leasehold improvements 34,019 33,788 Construction-in-progress 86,260 77,981 Total property, plant and equipment 199,178 187,749 Less accumulated depreciation and amortization (43,802) (36,573) Property, plant and equipment, net $ 155,376 $ 151,176 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following (in thousands): As of June 30, 2020 As of December 31, 2019 Employee compensation $ 39,018 $ 44,679 Manufacturing costs 33,171 23,126 Clinical and contract research organization costs 21,577 16,799 Collaboration research costs 7,886 27,142 Property, plant, and equipment 685 2,354 License and milestone fees 771 300 Professional fees 1,847 1,827 Other 30,657 25,329 Total accrued expenses and other current liabilities $ 135,612 $ 141,556 |
Collaborative arrangements (Tab
Collaborative arrangements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Agreement Transaction Price | The following tables summarize the total transaction price, the allocation of the total transaction price to the identified performance obligations under the arrangement (including those performance obligations that were completed as of the May 2020 contract modification date), and the amount of the transaction price unsatisfied as of June 30, 2020 (in thousands): Ide-cel transaction price as of June 30, Up-front non-refundable payments, option fee and milestone payments received prior to May 2020 $ 120,000 Allocated portion of the up-front non-refundable payment received in connection with the Amended Ide-cel CCPS and bb21217 License Agreement (2) 184,029 Estimated variable consideration (3) 83,083 $ 387,112 (1) Composed of all up-front payments and option fee and milestone payments received under the BMS Collaboration Agreement, Amended BMS Collaboration Agreement, Ide-cel License Agreement, and Ide-cel CCPS. This consideration was allocated to the performance obligations under the Ide-cel CCPS based on a relative standalone selling price (“SSP”) basis. The Company estimated the SSP of the ide-cel license after considering potential future cash flows under the license. The Company then discounted these probability-weighted cash flows to their present value. The Company estimated the SSP of each of the ide-cel research and development services and ide-cel manufacturing services to be provided based on the Company’s estimated cost of providing the services plus an applicable profit margin commensurate with observable market data for similar services. (2) This represents the portion of the $200.0 million up-front payment received under the Amended Ide-cel CCPS and Amended bb21217 License Agreement which was allocated to ide-cel. (3) Estimated variable consideration represents the estimated reimbursement from BMS for the manufacture of vectors and associated payload through development. Allocation of Transaction price unsatisfied as of June 30, 2020 Ide-cel research and development services $ 40,912 $ — Ide-cel license and manufacturing services 346,200 5,151 $ 387,112 $ 5,151 The following table summarizes the net collaborative arrangement revenue recognized or expense incurred for the joint ide-cel development efforts in the U.S. under ASC 808 related to the combined performance obligation for the license and vector manufacturing of ide-cel in the U.S. for the three and six months ended June 30, 2020, and 2019 (in thousands): For the three months ended June 30, For the six months ended June 30, 2020 2019 2020 2019 ASC 808 ide-cel license and manufacturing revenue - U.S. (1) $ 108,196 $ — $ 108,196 $ — ASC 808 ide-cel research and development expense - U.S. (1) $ — $ (1,065) $ (5,080) $ (4,309) (1) As noted above, the calculation of collaborative arrangement revenue or research and development expense to be recognized for joint ide-cel development efforts in the U.S. is performed on a quarterly basis. The calculation is independent of previous activity, which may result in fluctuations between revenue and expense recognition period over period, depending on the varying extent of effort performed by each party during the period. Revenue related to the combined unit of accounting for the ex-U.S. license and vector manufacturing services is accounted for in accordance with Topic 606. The following table summarizes the revenue recognized related to the combined unit of accounting for the ide-cel ex-U.S. license and vector manufacturing services for the three and six months ended June 30, 2020, and 2019 (in thousands): For the three months ended June 30, For the six months ended June 30, 2020 2019 2020 2019 ASC 606 ide-cel license and manufacturing revenue - ex-U.S. $ 73,850 $ 7,899 $ 87,820 $ 16,963 The following tables summarize the total transaction price, the allocation of the total transaction price to the identified performance obligations under the arrangement (including those performance obligations that were completed as of the May 2020 contract modification date), and the amount of the transaction price unsatisfied as of June 30, 2020 (in thousands): bb21217 transaction price as of June 30, 2020 Up-front non-refundable payment received prior to May 2020 contract modification (1) $ 15,000 Allocated portion of the up-front non-refundable payment received in connection with the Amended Ide-cel CCPS and bb21217 License Agreement (2) 15,971 Estimated variable consideration (3) 1,803 $ 32,774 (1) Composed of the up-front non-refundable payment received under the bb21217 License Agreement. This consideration was allocated to the performance obligations under the bb21217 License Agreement based on a relative SSP basis. The Company estimated the SSP of the bb21217 license after considering potential future cash flows under the license. The Company then discounted these probability-weighted cash flows to their present value. The Company estimated the SSP of each of the bb21217 research and development services and bb21217 manufacturing services to be provided based on the Company’s estimated cost of providing the services plus an applicable profit margin commensurate with observable market data for similar services. (2) This represents the portion of the $200.0 million up-front payment received under the Amended Ide-cel CCPS and Amended bb21217 License Agreement which was allocated to bb21217. (3) Estimated variable consideration represents the estimated reimbursement from BMS for the manufacture of vectors and associated payload through development. Allocation of transaction Transaction price unsatisfied as of June 30, 2020 bb21217 research and development services $ 5,444 $ — bb21217 license and manufacturing services 27,330 27,330 $ 32,774 $ 27,330 |
Summary of Contract Assets and Liabilities | The following table presents changes in the balances of the Company’s BMS receivables and contract liabilities during the six months ended June 30, 2020 (in thousands): Balance at December 31, Additions Deductions Balance at Receivables $ 400 $ 6,400 $ (2,800) $ 4,000 Contract liabilities: Deferred revenue $ 18,265 $ 200,000 $ (188,588) $ 29,677 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock-Based Compensation Expense by Award Type | Stock-based compensation expense by award type included within the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): For the three months ended June 30, For the six months ended June 30, 2020 2019 2020 2019 Stock options $ 26,073 $ 24,800 $ 50,513 $ 47,983 Restricted stock units 14,143 30,012 25,996 38,893 Employee stock purchase plan and other 8,313 299 8,313 576 $ 48,529 $ 55,111 $ 84,822 $ 87,452 |
Schedule of Stock-Based Compensation Expense by Classification | Stock-based compensation expense by classification included within the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): For the three months ended June 30, For the six months ended June 30, 2020 2019 2020 2019 Research and development $ 23,098 $ 29,694 $ 39,367 $ 45,210 Selling, general and administrative 25,431 25,417 45,455 42,242 $ 48,529 $ 55,111 $ 84,822 $ 87,452 |
Summary of Stock Option Activity Under Plan | The following table summarizes the stock option activity under the Company’s equity award plans: Shares (in thousands) Weighted- average exercise price per share Outstanding at December 31, 2019 5,483 $ 116.30 Granted 1,306 $ 72.50 Exercised (27) $ 40.91 Canceled, forfeited, or expired (296) $ 135.10 Outstanding at June 30, 2020 6,466 $ 106.90 Exercisable at June 30, 2020 3,442 $ 102.07 Vested and expected to vest at June 30, 2020 6,466 $ 106.90 |
Summary of Restricted Common Stock Awards | The following table summarizes the restricted stock unit activity under the Company’s equity award plans: Shares Weighted- Unvested balance at December 31, 2019 1,127 $ 146.10 Granted 879 $ 72.59 Vested (318) $ 143.73 Forfeited (95) $ 132.84 Unvested balance at June 30, 2020 1,593 $ 106.81 |
Net loss per share (Tables)
Net loss per share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share | The following common stock equivalents were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect (in thousands): For the three and six months ended June 30, 2020 2019 Outstanding stock options 6,466 5,393 Restricted stock units 1,593 1,103 ESPP shares and other 323 15 8,382 6,511 |
Description of the business - A
Description of the business - Additional Information (Detail) $ in Millions | Jun. 30, 2020USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash, cash equivalents and marketable securities | $ 1,600 |
Basis of presentation, princi_3
Basis of presentation, principles of consolidation and significant accounting policies - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2020segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities Held (Detail) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Amortized cost / Cost | ||
Equity securities | $ 20,017,000 | $ 20,017,000 |
Marketable securities | 407,606,000 | 915,152,000 |
Unrealized gains | ||
Equity securities | 0 | 0 |
Marketable securities | 2,914,000 | 2,838,000 |
Unrealized losses | ||
Equity securities | (10,490,000) | (7,147,000) |
Marketable securities | (10,495,000) | (7,238,000) |
Fair value | ||
Equity securities | 9,527,000 | 12,870,000 |
Marketable securities: | 400,025,000 | 910,752,000 |
Debt securities, available-for-sale, noncurrent | 0 | 0 |
U.S. government agency securities and treasuries | ||
Amortized cost / Cost | ||
Debt securities | 201,362,000 | 633,970,000 |
Unrealized gains | ||
Debt securities | 1,294,000 | 2,014,000 |
Unrealized losses | ||
Debt securities | (5,000) | (48,000) |
Fair value | ||
Debt securities | 202,651,000 | 635,936,000 |
Certificates of deposit | ||
Amortized cost / Cost | ||
Debt securities | 960,000 | |
Unrealized gains | ||
Debt securities | 0 | |
Unrealized losses | ||
Debt securities | 0 | |
Fair value | ||
Debt securities | 960,000 | |
Corporate bonds | ||
Amortized cost / Cost | ||
Debt securities | 151,305,000 | 185,827,000 |
Unrealized gains | ||
Debt securities | 1,620,000 | 824,000 |
Unrealized losses | ||
Debt securities | 0 | (43,000) |
Fair value | ||
Debt securities | 152,925,000 | 186,608,000 |
Commercial paper | ||
Amortized cost / Cost | ||
Debt securities | 34,922,000 | 74,378,000 |
Unrealized gains | ||
Debt securities | 0 | 0 |
Unrealized losses | ||
Debt securities | 0 | 0 |
Fair value | ||
Debt securities | $ 34,922,000 | $ 74,378,000 |
Fair value measurements - Recor
Fair value measurements - Recorded Amount of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Assets: | ||
Marketable securities: | $ 400,025 | $ 910,752 |
Equity securities | 9,527 | 12,870 |
Fair Value, Measurements, Recurring | ||
Assets: | ||
Cash and cash equivalents | 1,198,768 | 327,214 |
Equity securities | 9,527 | 12,870 |
Total | 1,598,793 | 1,237,966 |
Liabilities: | ||
Contingent consideration | 3,214 | 7,977 |
Total | 3,214 | 7,977 |
Fair Value, Measurements, Recurring | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 202,651 | 635,936 |
Fair Value, Measurements, Recurring | Certificates of deposit | ||
Assets: | ||
Marketable securities: | 960 | |
Fair Value, Measurements, Recurring | Corporate bonds | ||
Assets: | ||
Marketable securities: | 152,925 | 186,608 |
Fair Value, Measurements, Recurring | Commercial paper | ||
Assets: | ||
Marketable securities: | 34,922 | 74,378 |
Fair Value, Measurements, Recurring | Quoted prices in active markets (Level 1) | ||
Assets: | ||
Cash and cash equivalents | 1,198,768 | 311,245 |
Equity securities | 9,527 | 12,870 |
Total | 1,208,295 | 324,115 |
Liabilities: | ||
Contingent consideration | 0 | 0 |
Total | 0 | 0 |
Fair Value, Measurements, Recurring | Quoted prices in active markets (Level 1) | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Fair Value, Measurements, Recurring | Quoted prices in active markets (Level 1) | Certificates of deposit | ||
Assets: | ||
Marketable securities: | 0 | |
Fair Value, Measurements, Recurring | Quoted prices in active markets (Level 1) | Corporate bonds | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Fair Value, Measurements, Recurring | Quoted prices in active markets (Level 1) | Commercial paper | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | ||
Assets: | ||
Cash and cash equivalents | 0 | 15,969 |
Equity securities | 0 | 0 |
Total | 390,498 | 913,851 |
Liabilities: | ||
Contingent consideration | 0 | 0 |
Total | 0 | 0 |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 202,651 | 635,936 |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | Certificates of deposit | ||
Assets: | ||
Marketable securities: | 960 | |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | Corporate bonds | ||
Assets: | ||
Marketable securities: | 152,925 | 186,608 |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | Commercial paper | ||
Assets: | ||
Marketable securities: | 34,922 | 74,378 |
Fair Value, Measurements, Recurring | Significant unobservable inputs (Level 3) | ||
Assets: | ||
Cash and cash equivalents | 0 | 0 |
Equity securities | 0 | 0 |
Total | 0 | 0 |
Liabilities: | ||
Contingent consideration | 3,214 | 7,977 |
Total | 3,214 | 7,977 |
Fair Value, Measurements, Recurring | Significant unobservable inputs (Level 3) | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Fair Value, Measurements, Recurring | Significant unobservable inputs (Level 3) | Certificates of deposit | ||
Assets: | ||
Marketable securities: | 0 | |
Fair Value, Measurements, Recurring | Significant unobservable inputs (Level 3) | Corporate bonds | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Fair Value, Measurements, Recurring | Significant unobservable inputs (Level 3) | Commercial paper | ||
Assets: | ||
Marketable securities: | $ 0 | $ 0 |
Fair value measurements - Narra
Fair value measurements - Narrative (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Realized gain (loss) on available-for-sale securities | $ 0 | $ 0 | |||
Interest receivable | $ 1,700,000 | 1,700,000 | $ 3,600,000 | ||
Interest receivable, write-offs | 0 | $ 0 | 0 | 0 | |
Investment at fair value | 9,527,000 | 9,527,000 | $ 12,870,000 | ||
Other (Expense) Income, Net | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Unrealized gain (loss) on equity securities | $ 1,200,000 | $ (3,100,000) | $ (3,300,000) | $ (6,200,000) |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Unrealized Loss on Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Fair value | ||
Less than 12 months | $ 0 | $ 67,217 |
12 months or greater | 10,498 | 79,618 |
Total | 10,498 | 146,835 |
Unrealized losses | ||
Less than 12 months | 0 | (46) |
12 months or greater | (5) | (45) |
Total | (5) | (91) |
U.S. government agency securities and treasuries | ||
Fair value | ||
Less than 12 months | 0 | 13,234 |
12 months or greater | 10,498 | 79,618 |
Total | 10,498 | 92,852 |
Unrealized losses | ||
Less than 12 months | 0 | (3) |
12 months or greater | (5) | (45) |
Total | $ (5) | (48) |
Corporate bonds | ||
Fair value | ||
Less than 12 months | 53,983 | |
12 months or greater | 0 | |
Total | 53,983 | |
Unrealized losses | ||
Less than 12 months | (43) | |
12 months or greater | 0 | |
Total | $ (43) |
Property, plant and equipment_3
Property, plant and equipment, net - Summary of Property, Plant and Equipment Net (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | $ 199,178 | $ 187,749 |
Less accumulated depreciation and amortization | (43,802) | (36,573) |
Property, plant and equipment, net | 155,376 | 151,176 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 1,210 | 1,210 |
Building | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 15,745 | 15,664 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 6,837 | 6,947 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 7,611 | 7,599 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 47,496 | 44,560 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 34,019 | 33,788 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | $ 86,260 | $ 77,981 |
Property, plant and equipment_4
Property, plant and equipment, net - Narrative (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 199,178 | $ 187,749 |
Remaining Construction In Progress North Carolina Manufacturing Facility | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 81,700 | $ 74,200 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Employee compensation | $ 39,018 | $ 44,679 |
Manufacturing costs | 33,171 | 23,126 |
Clinical and contract research organization costs | 21,577 | 16,799 |
Collaboration research costs | 7,886 | 27,142 |
Property, plant, and equipment | 685 | 2,354 |
License and milestone fees | 771 | 300 |
Professional fees | 1,847 | 1,827 |
Other | 30,657 | 25,329 |
Total accrued expenses and other current liabilities | $ 135,612 | $ 141,556 |
Leases - Narrative (Detail)
Leases - Narrative (Detail) € in Millions | 1 Months Ended | 6 Months Ended | 22 Months Ended | |||||||
Sep. 30, 2019ft²$ / ft² | Apr. 30, 2019USD ($)ft²$ / ft² | Jul. 31, 2018ft²$ / ft² | Sep. 30, 2015USD ($)ft²$ / ft² | Jun. 30, 2020USD ($)lease_term | Mar. 31, 2018USD ($) | Mar. 31, 2020EUR (€) | Dec. 31, 2019lease_term | Nov. 30, 2016 | Jun. 30, 2016 | |
Seattle, Washington | ||||||||||
Lessee, Lease, Description [Line Items] | ||||||||||
Lease building space (in sq ft) | ft² | 22,188 | 36,126 | ||||||||
Annual lease rent per square foot (in dollars per sq ft) | $ / ft² | 62.80 | 54 | ||||||||
Renewal term | 5 years | |||||||||
Lease arrangements annual increase percentage | 2.50% | 2.50% | ||||||||
Operating lease, term of contract extension | 16 months | |||||||||
Number of contracts | lease_term | 2 | |||||||||
60 Binney Street Lease | ||||||||||
Lessee, Lease, Description [Line Items] | ||||||||||
Lease building space (in sq ft) | ft² | 253,108 | |||||||||
Annual lease rent per square foot (in dollars per sq ft) | $ / ft² | 72.50 | |||||||||
Lease payments base annual rent | $ 18,400,000 | |||||||||
Lease rent, annual increase percentage | 1.75% | |||||||||
Collateralized letter of credit | $ 13,800,000 | |||||||||
Decrease in letter of credit under the terms of the lease | 9,200,000 | |||||||||
Landlord contribution for cost of construction and tenant improvements | $ 42,400,000 | |||||||||
Number of terms | lease_term | 2 | |||||||||
Renewal term | 5 years | |||||||||
50 Binney Street Sublease | ||||||||||
Lessee, Lease, Description [Line Items] | ||||||||||
Collateralized letter of credit | $ 40,100,000 | |||||||||
Area of office space for sublease | ft² | 267,278 | |||||||||
Rate of area for sublease per square feet | $ / ft² | 99.95 | |||||||||
Annual expense | $ 26,700,000 | |||||||||
Annual rent increase percentage | 3.00% | |||||||||
Payment commencement, term | 90 days | |||||||||
Upfront payment for purchase of furniture and equipment | $ 7,500,000 | |||||||||
50 Binney Street Sublease | Minimum | ||||||||||
Lessee, Lease, Description [Line Items] | ||||||||||
Option to postpone commencement, term | 9 months | |||||||||
Manufacturing Facility | ||||||||||
Lessee, Lease, Description [Line Items] | ||||||||||
Renewal term | 3 years | |||||||||
Annual expense | 5,100,000 | |||||||||
Lease period | 5 years | 12 years | ||||||||
Milestone paid | $ 12,000,000 | |||||||||
Lease not yet commenced, amount | $ 8,000,000 | |||||||||
Termination fees, term | 24 months | |||||||||
Annual maintenance and production fees | € | € 16.5 | |||||||||
Lease notice period | 12 months |
Commitments and contingencies -
Commitments and contingencies - Additional Information (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Commitments And Contingencies Disclosure [Line Items] | |
Decrease in expected future minimum purchase commitments | $ 89.2 |
Pregenen | |
Commitments And Contingencies Disclosure [Line Items] | |
Contingent cash payments | 120 |
Pregenen | Clinical Milestone Payments | |
Commitments And Contingencies Disclosure [Line Items] | |
Contingent cash payments | 20.1 |
Pregenen | Commercial Milestones Payments | |
Commitments And Contingencies Disclosure [Line Items] | |
Contingent cash payments | $ 99.9 |
Collaborative arrangements - Ad
Collaborative arrangements - Additional Information (Detail) | Aug. 24, 2018USD ($)target$ / sharesshares | May 31, 2020USD ($) | Sep. 30, 2017USD ($) | Feb. 29, 2016USD ($) | Jun. 30, 2015USD ($)product | Mar. 31, 2013USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Sep. 28, 2017USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Deferred revenue | $ (11,412,000) | $ 11,716,000 | |||||||||||
Investment in common stock | $ 541,500,000 | 541,536,000 | 0 | ||||||||||
Bristol-Myers Squibb | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Contract with customer liability | $ 29,677,000 | 29,677,000 | $ 18,265,000 | ||||||||||
Term of collaboration agreement | 3 years | ||||||||||||
Deferred revenue | (7,300,000) | ||||||||||||
Bristol-Myers Squibb | Collaborative Arrangement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Contract with customer liability | $ 75,000,000 | ||||||||||||
Bristol-Myers Squibb | Amended Collaborative Arrangement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Contract with customer liability | $ 25,000,000 | ||||||||||||
Term of collaboration agreement | 3 years | ||||||||||||
Number of product candidates | product | 2 | ||||||||||||
Bristol-Myers Squibb | Ide-cel License Agreement | First Product Candidates | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Collaboration agreement, option fee received | $ 10,000,000 | ||||||||||||
Bristol-Myers Squibb | Ide-cel License Agreement | First Product Candidates | U.S. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments receivable | 85,000,000 | ||||||||||||
Bristol-Myers Squibb | Ide-cel License Agreement | First Product Candidates | Outside of U.S. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments receivable | $ 55,000,000 | ||||||||||||
Bristol-Myers Squibb | Ide-cel Co-Development, Co-Promote and Profit Share Agreement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payment achieved | $ 10,000,000 | ||||||||||||
Bristol-Myers Squibb | Ide-cel Co-Development, Co-Promote and Profit Share Agreement | U.S. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments receivable | $ 10,000,000 | ||||||||||||
Bristol-Myers Squibb | Ide-cel Co-Development, Co-Promote and Profit Share Agreement | Outside of U.S. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments receivable | $ 60,000,000 | ||||||||||||
Bristol-Myers Squibb | Amended Ide Cel Co Development, Co-Promote And Profit Share Agreement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone and royalty obligation buy-out | $ 200,000,000 | 184,029,000 | 184,029,000 | ||||||||||
Deferred revenue | 188,600,000 | ||||||||||||
Catch-up adjustment to revenue | 169,200,000 | ||||||||||||
Bristol-Myers Squibb | bb21217 License Agreement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Collaboration agreement, option fee received | $ 15,000,000 | 15,000,000 | |||||||||||
Milestone payment achieved | 10,000,000 | ||||||||||||
Milestone and royalty obligation buy-out | 15,971,000 | $ 15,971,000 | |||||||||||
Additional fee receivable if option to co-develop and co-promote is not exercised | $ 10,000,000 | ||||||||||||
Deferred revenue recognition period | 2 years | ||||||||||||
Bristol-Myers Squibb | bb21217 License Agreement | U.S. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments receivable | 85,000,000 | ||||||||||||
Bristol-Myers Squibb | bb21217 License Agreement | Outside of U.S. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments receivable | $ 55,000,000 | ||||||||||||
Bristol-Myers Squibb | Ide-cel License and Manufacturing Services | License and Manufacturing Services | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Contract with customer liability | 3,900,000 | $ 3,900,000 | 8,500,000 | ||||||||||
Remaining performance obligation revenue | 5,200,000 | 5,200,000 | |||||||||||
Bristol-Myers Squibb | Ide-cel License and Manufacturing Services | License and Manufacturing Services | Outside of U.S. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Revenue | 73,850,000 | 7,899,000 | 87,820,000 | 16,963,000 | |||||||||
Bristol-Myers Squibb | Ide-cel Research and Development | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Revenue | 0 | 2,500,000 | 0 | 2,300,000 | |||||||||
Bristol-Myers Squibb | bb21217 Research and Development Services | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Collaboration agreement, transaction price | 5,444,000 | 5,444,000 | |||||||||||
Remaining performance obligation revenue | 0 | 0 | |||||||||||
Bristol-Myers Squibb | bb21217 Research and Development Services | Phase I, Initial Obligation | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Revenue | 0 | 700,000 | 0 | 1,400,000 | |||||||||
Bristol-Myers Squibb | bb21217 Research and Development Services | Phase I, Additional Obligation | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Revenue | 4,000,000 | 6,400,000 | |||||||||||
Bristol-Myers Squibb | bb21217 license and manufacturing services | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Collaboration agreement, transaction price | 27,330,000 | 27,330,000 | |||||||||||
Remaining performance obligation revenue | 27,330,000 | 27,330,000 | |||||||||||
Bristol-Myers Squibb | bb21217 license and manufacturing services | License and Manufacturing Services | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Contract with customer liability | 25,800,000 | 25,800,000 | 9,800,000 | ||||||||||
Liability, revenue recognized | 0 | 0 | 0 | 0 | |||||||||
Remaining performance obligation revenue | 27,300,000 | 27,300,000 | |||||||||||
Regeneron Collaboration Agreement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Number of initial collaboration targets | target | 6 | ||||||||||||
Research collaboration term | 5 years | ||||||||||||
Joint research activities remaining to be recognized | 34,400,000 | 34,400,000 | $ 38,200,000 | ||||||||||
Regeneron Collaboration Agreement | Collaboration | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Liability, revenue recognized | $ 1,500,000 | $ 500,000 | $ 3,800,000 | $ 2,500,000 | |||||||||
Regeneron Collaboration Agreement | Maximum | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments receivable | $ 130,000,000 | ||||||||||||
Regeneron Collaboration Agreement | Research and Development Services | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Collaboration agreement, transaction price | 100,000,000 | ||||||||||||
Purchase price premium | $ 37,000,000 | ||||||||||||
Collaborative arrangement amortization period | 5 years | ||||||||||||
Collaborative arrangement amount attributed to equity sold | $ 54,500,000 | ||||||||||||
Collaborative arrangement amount attributed to joint research activities | $ 45,500,000 | ||||||||||||
Regeneron Collaboration Agreement | Share Purchase Agreement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Common stock shares issued (in shares) | shares | 400,000 | ||||||||||||
Common stock price per share | $ / shares | $ 238.10 | ||||||||||||
Investment in common stock | $ 100,000,000 | ||||||||||||
Purchase price premium | $ 37,000,000 | ||||||||||||
Collaborative arrangement research initial funding obligation, percentage | 50.00% | ||||||||||||
Regeneron Collaboration Agreement | Share Purchase Agreement | Common Shares | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Common stock shares issued (in shares) | shares | 400,000 | ||||||||||||
Investment in common stock | $ 63,000,000 |
Collaborative arrangements - Su
Collaborative arrangements - Summary of Total Transaction Price, Allocation of Total Transaction Price to Identified Performance Obligations Under Arrangement and Amount of Transaction Price Unsatisfied (Detail) - Bristol-Myers Squibb - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | |
Sep. 30, 2017 | Jun. 30, 2020 | May 31, 2020 | |
Collaborative Arrangement | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Up-front non-refundable payment | $ 120,000 | ||
Amended Ide Cel Co Development, Co-Promote And Profit Share Agreement | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Milestone and royalty obligation buy-out | 184,029 | $ 200,000 | |
Vectors and Associated Payload | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Estimated variable consideration | 83,083 | ||
Ide-cel Research and Development Services | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaboration agreement, transaction price | 40,912 | ||
Transaction price unsatisfied | 0 | ||
Ide-cel Manufacturing Services | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaboration agreement, transaction price | 346,200 | ||
Transaction price unsatisfied | 5,151 | ||
Ide-cel Transaction Price | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaboration agreement, transaction price | 387,112 | ||
Transaction price unsatisfied | 5,151 | ||
bb21217 License Agreement | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Milestone and royalty obligation buy-out | 15,971 | ||
Collaboration agreement, license fee | $ 15,000 | 15,000 | |
Manufacturing Services | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Estimated variable consideration | 1,803 | ||
bb21217 Transaction Price | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaboration agreement, transaction price | 32,774 | ||
Transaction price unsatisfied | 27,330 | ||
bb21217 Research and Development Services | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaboration agreement, transaction price | 5,444 | ||
Transaction price unsatisfied | 0 | ||
bb21217 license and manufacturing services | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaboration agreement, transaction price | 27,330 | ||
Transaction price unsatisfied | $ 27,330 |
Collaborative arrangements - _2
Collaborative arrangements - Summary of Revenue Recognized or Expense Incurred for Joint Ide-cel Development Efforts Related to Combined Unit of Accounting for its License and Vector Manufacturing of Ide-cel (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Research and Development Expense | $ (156,308) | $ (146,540) | $ (310,431) | $ (269,180) |
Bristol-Myers Squibb | U.S. | Ide-cel Research and Development Services | License and Manufacturing Services | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Research and Development Expense | 0 | (1,065) | (5,080) | (4,309) |
Bristol-Myers Squibb | U.S. | Ide Cel Revenue Services [Member] | License and Manufacturing Services | Accounting Standards Update 2014-09 [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue | 108,196 | 0 | 108,196 | 0 |
Bristol-Myers Squibb | Outside of U.S. | Ide-cel License and Manufacturing Services | License and Manufacturing Services | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue | $ 73,850 | $ 7,899 | $ 87,820 | $ 16,963 |
Collaborative arrangements - Ch
Collaborative arrangements - Changes in Balances of Company's Receivables and Contract Liabilities (Detail) - Bristol-Myers Squibb $ in Thousands | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Receivables | |
Balance at beginning of period | $ 400 |
Additions | 6,400 |
Deductions | (2,800) |
Balance at end of period | 4,000 |
Contract liabilities: | |
Balance at beginning of period | 18,265 |
Additions | 200,000 |
Deductions | (188,588) |
Balance at end of period | $ 29,677 |
Equity - Narrative (Detail)
Equity - Narrative (Detail) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 1 Months Ended | 6 Months Ended | |
May 31, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | |
Equity [Abstract] | |||
Number of shares issued in public offering (in shares) | 10.5 | ||
Shares issued, price per share (in dollars per share) | $ 55 | ||
Proceeds from public offering of common stock, net of issuance costs | $ 541,500 | $ 541,536 | $ 0 |
Stock-based compensation - Narr
Stock-based compensation - Narrative (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jan. 31, 2020 | Jan. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Increased number of issuance of awards under the 2013 Plan (in shares) | 2,200,000 | 2,200,000 | |||||
Number of shares available for issuance (in shares) | 2,400,000 | 2,400,000 | |||||
Stock-based compensation expense | $ 48,529 | $ 55,111 | $ 84,822 | $ 87,452 | |||
Unrecognized stock- based compensation expense related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | 332,000 | $ 332,000 | |||||
Expected weighted-average period related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | 2 years 6 months | ||||||
Stock option share exercised (in shares) | 27,000 | ||||||
Proceed from option share exercised | $ 1,100 | ||||||
Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock option share exercised (in shares) | 100,000 | ||||||
Employee stock purchase plan and other | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation expense | $ 8,313 | $ 299 | $ 8,313 | $ 576 | |||
Common shares reserved for future issuance (in shares) | 200,000 | ||||||
Employee stock purchase plan and other | Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock issued under plan (in shares) | 100,000 | 100,000 |
Stock-based compensation - Summ
Stock-based compensation - Summary of Stock-Based Compensation Expense by Award Type (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 48,529 | $ 55,111 | $ 84,822 | $ 87,452 |
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 26,073 | 24,800 | 50,513 | 47,983 |
Restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 14,143 | 30,012 | 25,996 | 38,893 |
Employee stock purchase plan and other | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 8,313 | $ 299 | $ 8,313 | $ 576 |
Stock-based compensation - Sche
Stock-based compensation - Schedule of Stock-Based Compensation Expense by Classification (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 48,529 | $ 55,111 | $ 84,822 | $ 87,452 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 23,098 | 29,694 | 39,367 | 45,210 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 25,431 | $ 25,417 | $ 45,455 | $ 42,242 |
Stock-based compensation - Su_2
Stock-based compensation - Summary of Stock Option Activity Under Plan (Detail) - $ / shares shares in Thousands | 6 Months Ended |
Jun. 30, 2020 | |
Shares (in thousands) | |
Outstanding at beginning of period (in shares) | 5,483 |
Granted (in shares) | 1,306 |
Exercised (in shares) | (27) |
Canceled, forfeited, or expired (in shares) | (296) |
Outstanding at end of period (in shares) | 6,466 |
Exercisable at end of period (in shares) | 3,442 |
Vested and expected to vest at end of period (in shares) | 6,466 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |
Outstanding at beginning of period (in dollars per share) | $ 116.30 |
Granted (in dollars per share) | 72.50 |
Exercised (in dollars per share) | 40.91 |
Canceled, forfeited, or expired (in dollars per share) | 135.10 |
Outstanding at end of period (in dollars per share) | 106.90 |
Exercisable at end of period (in dollars per share) | 102.07 |
Vested and expected to vest at end of period (in dollars per share) | $ 106.90 |
Stock-based compensation - Su_3
Stock-based compensation - Summary of Restricted Stock Units (Detail) - Restricted stock units shares in Thousands | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Shares (in thousands) | |
Unvested balance at beginning of period (in shares) | shares | 1,127 |
Granted (in shares) | shares | 879 |
Vested (in shares) | shares | (318) |
Forfeited (in shares) | shares | (95) |
Unvested balance at end of period (in shares) | shares | 1,593 |
Weighted- average grant date fair value | |
Unvested balance at beginning of period (in dollars per share) | $ / shares | $ 146.10 |
Granted (in dollars per share) | $ / shares | 72.59 |
Vested (in dollars per share) | $ / shares | 143.73 |
Forfeited (in dollars per share) | $ / shares | 132.84 |
Unvested balance at end of period (in dollars per share) | $ / shares | $ 106.81 |
Net loss per share - Common Sto
Net loss per share - Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from the calculation of diluted net loss per share (in shares) | 8,382 | 6,511 |
Outstanding stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from the calculation of diluted net loss per share (in shares) | 6,466 | 5,393 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from the calculation of diluted net loss per share (in shares) | 1,593 | 1,103 |
ESPP shares and other | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from the calculation of diluted net loss per share (in shares) | 323 | 15 |
Uncategorized Items - blue-2020
Label | Element | Value |
Restricted Cash, Current | us-gaap_RestrictedCashCurrent | $ 100,000 |
Restricted Cash, Current | us-gaap_RestrictedCashCurrent | 0 |
Restricted Cash, Noncurrent | us-gaap_RestrictedCashNoncurrent | 54,494,000 |
Restricted Cash, Noncurrent | us-gaap_RestrictedCashNoncurrent | $ 54,502,000 |
Accounting Standards Update [Extensible List] | us-gaap_AccountingStandardsUpdateExtensibleList | us-gaap:AccountingStandardsUpdate201602Member |