Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 03, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
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 | 455 Grand Union Boulevard | |
Entity Address, City or Town | Somerville | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02145 | |
City Area Code | 339 | |
Local Phone Number | 499-9300 | |
Title of 12(b) Security | Common Stock, $0.01 par value per share | |
Trading Symbol | BLUE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 77,121,751 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001293971 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 81,499 | $ 161,160 |
Marketable securities | 51,010 | 138,343 |
Prepaid expenses | 24,473 | 25,628 |
Receivables and other current assets | 10,476 | 11,389 |
Total current assets | 167,458 | 336,520 |
Marketable securities | 40,641 | 97,114 |
Property, plant and equipment, net | 14,566 | 9,706 |
Goodwill | 5,646 | 5,646 |
Operating lease right-of-use assets | 292,731 | 91,532 |
Restricted cash and other non-current assets | 52,550 | 53,277 |
Total assets | 573,592 | 593,795 |
Current liabilities: | ||
Accounts payable | 24,865 | 25,883 |
Accrued expenses and other current liabilities | 75,550 | 103,958 |
Operating lease liability, current portion | 48,446 | 23,152 |
Total current liabilities | 148,861 | 152,993 |
Operating lease liability, net of current portion | 244,522 | 66,432 |
Other non-current liabilities | 93 | 93 |
Total liabilities | 393,476 | 219,518 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value, 5,000 shares authorized; 0 shares issued and outstanding at June 30, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.01 par value, 125,000 shares authorized; 73,551 and 71,115 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 735 | 711 |
Additional paid-in capital | 4,126,012 | 4,096,402 |
Accumulated other comprehensive loss | (4,416) | (2,911) |
Accumulated deficit | (3,942,215) | (3,719,925) |
Total stockholders’ equity | 180,116 | 374,277 |
Total liabilities and stockholders’ equity | $ 573,592 | $ 593,795 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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 value (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) | 73,551,000 | 71,115,000 |
Common stock, shares outstanding (in shares) | 73,551,000 | 71,115,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue: | ||||
Total revenues | $ 1,519 | $ 143 | $ 3,464 | $ 1,037 |
Operating expenses: | ||||
Research and development | 63,841 | 84,645 | 141,716 | 167,488 |
Selling, general and administrative | 36,694 | 54,984 | 72,800 | 118,553 |
Cost of product revenue | 1,745 | 15,215 | 10,055 | 15,791 |
Restructuring expenses | 6,639 | 0 | 6,639 | 0 |
Total operating expenses | 108,919 | 154,844 | 231,210 | 301,832 |
Loss from operations | (107,400) | (154,701) | (227,746) | (300,795) |
Interest income, net | 174 | 218 | 280 | 573 |
Other (expense) income, net | 7,088 | (1,274) | 5,176 | 23,027 |
Loss before income taxes | (100,138) | (155,757) | (222,290) | (277,195) |
Income tax (expense) benefit | 0 | (216) | 0 | (282) |
Net loss from continuing operations | (100,138) | (155,973) | (222,290) | (277,477) |
Net loss from discontinued operations | 0 | (85,729) | 0 | (170,033) |
Net loss | $ (100,138) | $ (241,702) | $ (222,290) | $ (447,510) |
Net loss per share from continuing operations - basic (in dollars per share) | $ (1.36) | $ (2.31) | $ (3.02) | $ (4.13) |
Net loss per share from continuing operations - diluted (in dollars per share) | (1.36) | (2.31) | (3.02) | (4.13) |
Net loss per share from discontinued operations - basic (in dollars per share) | 0 | (1.27) | 0 | (2.53) |
Net loss per share from discontinued operations - diluted (in dollars per share) | 0 | (1.27) | 0 | (2.53) |
Net loss per share - basic (in dollars per share) | (1.36) | (3.58) | (3.02) | (6.66) |
Net loss per share - diluted (in dollars per share) | $ (1.36) | $ (3.58) | $ (3.02) | $ (6.66) |
Weighted-average number of common shares used in computing net loss per share - basic (in shares) | 73,767 | 67,487 | 73,727 | 67,233 |
Weighted-average number of common shares used in computing net loss per share - diluted (in shares) | 73,767 | 67,487 | 73,727 | 67,233 |
Other comprehensive (loss) income: | ||||
Other comprehensive income | $ 43 | $ (328) | $ (1,505) | $ (272) |
Comprehensive loss | (100,095) | (242,030) | (223,795) | (447,782) |
Product revenue | ||||
Revenue: | ||||
Revenue | 1,331 | 0 | 2,739 | 724 |
Other revenue | ||||
Revenue: | ||||
Revenue | $ 188 | $ 143 | $ 725 | $ 313 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Other comprehensive income (loss), tax | $ 0 | $ 0 | $ 0 | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (unaudited) - USD ($) shares in Thousands, $ in Thousands | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive loss | Accumulated deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 66,432 | ||||
Beginning balance at Dec. 31, 2020 | $ 1,355,056 | $ 665 | $ 4,260,443 | $ (5,505) | $ (2,900,547) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Vesting of restricted stock units (in shares) | 294 | ||||
Vesting of restricted stock units | 0 | $ 3 | (3) | ||
Exercise of stock options (in shares) | 207 | ||||
Exercise of stock options | 1,219 | $ 2 | 1,217 | ||
Purchase of common stock under ESPP (in shares) | 67 | ||||
Purchase of common stock under ESPP | 1,707 | $ 1 | 1,706 | ||
Stock-based compensation | 36,090 | 36,090 | |||
Issuance of unrestricted stock awards to settle accrued employee compensation (in shares) | 422 | ||||
Issuance of unrestricted stock awards to settle accrued employee compensation | 12,013 | $ 4 | 12,009 | ||
Other comprehensive income | 56 | 56 | |||
Net loss | (205,808) | (205,808) | |||
Ending balance, shares (in shares) at Mar. 31, 2021 | 67,422 | ||||
Ending balance at Mar. 31, 2021 | 1,200,333 | $ 675 | 4,311,462 | (5,449) | (3,106,355) |
Beginning balance (in shares) at Dec. 31, 2020 | 66,432 | ||||
Beginning balance at Dec. 31, 2020 | 1,355,056 | $ 665 | 4,260,443 | (5,505) | (2,900,547) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Other comprehensive income | (272) | ||||
Net loss | (447,510) | ||||
Ending balance, shares (in shares) at Jun. 30, 2021 | 67,551 | ||||
Ending balance at Jun. 30, 2021 | 984,561 | $ 676 | 4,337,719 | (5,777) | (3,348,057) |
Beginning balance (in shares) at Mar. 31, 2021 | 67,422 | ||||
Beginning balance at Mar. 31, 2021 | 1,200,333 | $ 675 | 4,311,462 | (5,449) | (3,106,355) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Vesting of restricted stock units (in shares) | 127 | ||||
Vesting of restricted stock units | 0 | $ 1 | (1) | ||
Exercise of stock options (in shares) | 2 | ||||
Exercise of stock options | 36 | 36 | |||
Stock-based compensation | 26,222 | 26,222 | |||
Other comprehensive income | (328) | (328) | |||
Net loss | (241,702) | (241,702) | |||
Ending balance, shares (in shares) at Jun. 30, 2021 | 67,551 | ||||
Ending balance at Jun. 30, 2021 | $ 984,561 | $ 676 | 4,337,719 | (5,777) | (3,348,057) |
Beginning balance (in shares) at Dec. 31, 2021 | 71,115 | 71,115 | |||
Beginning balance at Dec. 31, 2021 | $ 374,277 | $ 711 | 4,096,402 | (2,911) | (3,719,925) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Vesting of restricted stock units (in shares) | 310 | ||||
Vesting of restricted stock units | 0 | $ 3 | (3) | ||
Exercise of stock options (in shares) | 1 | ||||
Exercise of stock options | 1 | 1 | |||
Stock-based compensation | 12,681 | 12,681 | |||
Issuance of unrestricted stock awards to settle accrued employee compensation (in shares) | 12 | ||||
Other comprehensive income | (1,548) | (1,548) | |||
Net loss | (122,152) | (122,152) | |||
Ending balance, shares (in shares) at Mar. 31, 2022 | 71,438 | ||||
Ending balance at Mar. 31, 2022 | $ 263,259 | $ 714 | 4,109,081 | (4,459) | (3,842,077) |
Beginning balance (in shares) at Dec. 31, 2021 | 71,115 | 71,115 | |||
Beginning balance at Dec. 31, 2021 | $ 374,277 | $ 711 | 4,096,402 | (2,911) | (3,719,925) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 2 | ||||
Other comprehensive income | $ (1,505) | ||||
Net loss | $ (222,290) | ||||
Ending balance, shares (in shares) at Jun. 30, 2022 | 73,551 | 73,551 | |||
Ending balance at Jun. 30, 2022 | $ 180,116 | $ 735 | 4,126,012 | (4,416) | (3,942,215) |
Beginning balance (in shares) at Mar. 31, 2022 | 71,438 | ||||
Beginning balance at Mar. 31, 2022 | 263,259 | $ 714 | 4,109,081 | (4,459) | (3,842,077) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Vesting of restricted stock units (in shares) | 60 | ||||
Vesting of restricted stock units | 0 | $ 1 | (1) | ||
Exercise of stock options (in shares) | 1 | ||||
Exercise of stock options | 1 | 1 | |||
Stock-based compensation | 8,908 | 8,908 | |||
Issuance of unrestricted stock awards to settle accrued employee compensation (in shares) | 2,052 | ||||
Issuance of unrestricted stock awards to settle accrued employee compensation | 8,043 | $ 20 | 8,023 | ||
Other comprehensive income | 43 | 43 | |||
Net loss | $ (100,138) | (100,138) | |||
Ending balance, shares (in shares) at Jun. 30, 2022 | 73,551 | 73,551 | |||
Ending balance at Jun. 30, 2022 | $ 180,116 | $ 735 | $ 4,126,012 | $ (4,416) | $ (3,942,215) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (222,290) | $ (447,510) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Change in fair value of contingent consideration | 0 | 416 |
Depreciation and amortization | 2,358 | 11,353 |
Stock-based compensation expense | 21,298 | 73,687 |
Loss (gain) on equity securities | 3,135 | (28,286) |
Excess inventory reserve | 7,519 | 15,084 |
Other non-cash items | 661 | 6,228 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (9,629) | (3,481) |
Operating lease right-of-use assets | 17,636 | 15,074 |
Accounts payable | (1,175) | 7,475 |
Accrued expenses and other liabilities | (28,565) | 17,453 |
Operating lease liabilities | (10,602) | (16,468) |
Net cash used in operating activities | (219,654) | (348,975) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (6,836) | (9,204) |
Purchases of marketable securities | 0 | (196,145) |
Proceeds from maturities of marketable securities | 108,225 | 557,751 |
Proceeds from sales of marketable securities | 30,213 | 31,318 |
Purchase of intangible assets | 0 | (2,000) |
Net cash provided by investing activities | 131,602 | 381,720 |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options and ESPP contributions | 0 | 4,192 |
Proceeds from the secondary public offering, net of issuance costs | 8,043 | 0 |
Net cash provided by financing activities | 8,043 | 4,192 |
(Decrease) increase in cash, cash equivalents and restricted cash | (80,009) | 36,937 |
Cash, cash equivalents and restricted cash at beginning of period | 206,693 | 373,728 |
Cash, cash equivalents and restricted cash at end of period | 126,684 | 410,665 |
Reconciliation of cash, cash equivalents and restricted cash: | ||
Cash and cash equivalents | 81,499 | 353,468 |
Restricted cash included in receivables and other current assets | 1,635 | 2,687 |
Restricted cash included in restricted cash and other non-current assets | 43,550 | 54,510 |
Total cash, cash equivalents and restricted cash | 126,684 | 410,665 |
Supplemental cash flow disclosures from investing and financing activities: | ||
Purchases of property, plant and equipment included in accounts payable and accrued expenses | 842 | 1,508 |
Right-of-use assets obtained in exchange for operating lease liabilities | 218,836 | 22,049 |
Issuance of unrestricted stock awards to settle accrued employee compensation | 0 | 12,013 |
Purchases of intangible assets included in accounts payable and accrued expenses, net of reimbursement receivable from collaboration partner | $ 0 | $ 6,500 |
Description of the business
Description of the business | 6 Months Ended |
Jun. 30, 2022 | |
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. 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") being developed as a treatment for β-thalassemia; lovotibeglogene autotemcel ("lovo-cel", formerly "LentiGlobin for SCD") being developed as a treatment for sickle cell disease ("SCD"); and elivaldogene autotemcel ("eli-cel", formerly "Lenti-D gene therapy") being developed as a treatment for cerebral adrenoleukodystrophy ("CALD"). In August 2021, the Company announced its intent to focus its severe genetic disease business on the U.S. market and further invest in research and development for its core programs in β-thalassemia, SCD, and CALD. As part of the strategy to focus on the U.S. market, it began executing an orderly wind down of its European operations, which will result in a reduction of selling, general and administrative costs and had an impact on the Company's excess inventory analysis, which is based on sales forecasts and projected inventory consumption levels. In November 2021, the Company completed the separation of its severe genetic disease and oncology programs into two separate, independent publicly traded companies, bluebird bio, Inc. and 2seventy bio, Inc. (“2seventy bio”), a Delaware corporation and wholly-owned subsidiary of the Company prior to the separation. bluebird retained its severe genetic disease programs, including programs for β-thalassemia, SCD, and CALD, with a focus on the U.S. market. In April 2022, the Board of Directors approved a comprehensive restructuring plan intended to reduce operating expenses and enhance the Company’s focus on achieving U.S. Food and Drug Administration ("FDA") approval for its programs in the U.S. The Company intends to maintain targeted research efforts focused on in-vivo lentiviral vector ("LVV") gene therapy and to deprioritize direct investments in reduced toxicity conditioning and cryopreserved apheresis. As part of the restructuring, bluebird plans to reduce its workforce by approximately 30% across the second and third quarters of 2022. Refer to Note 14, Reduction in workforce, for more information on this restructuring. On June 22, 2022, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Goldman Sachs & Co. LLC (“Goldman”) to sell shares of the Company’s common stock up to $75.0 million, from time to time, through an “at the market” equity offering program under which Goldman will act as manager. The Equity Distribution Agreement also provides for the sale of shares to Goldman directly as principal, in which case the Company and Goldman will enter into a separate terms agreement. The Company will pay Goldman a commission equal to up to 3.0% of the gross proceeds of any Common Stock sold through Goldman under the Equity Distribution Agreement. In the three months ended June 30, 2022, the Company sold 2.1 million shares of common stock at-the-market under the Equity Distribution Agreement, resulting in gross proceeds of approximately $8.3 million ($8.0 million net of offering costs). Refer to Note 10, Equity , for more information. As of June 30, 2022, the Company had cash, cash equivalents and marketable securities of approximately $173.2 million. The Company has incurred losses since inception and to date has financed its operations primarily through the sale of equity securities and, to a lesser extent, through collaboration agreements and grants from charitable foundations. As of June 30, 2022, the Company had an accumulated deficit of $3.94 billion. During the six months ended June 30, 2022, the Company incurred a loss of $222.3 million and used $219.7 million of cash in operations. The Company expects to continue to generate operating losses and negative operating cash flows for the next few years and will need additional funding to support its planned operating activities through profitability. The transition to profitability is dependent upon the successful development, approval, and commercialization of beti-cel, eli-cel, and lovo-cel, and the achievement of a level of revenues adequate to support its cost structure. In accordance with Accounting Standards Codification 205-40, Going Concern ("ASC 205-40"), the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from future equity or debt issuances, the release of restricted cash related to the Company’s 50 Binney Street lease, and the potential sale of priority review vouchers cannot be considered probable at this time because these plans are not entirely within the Company’s control nor have been approved by the Board of Directors as of the date of these condensed consolidated financial statements. The restructuring plan described above was approved by the Board of Directors in April 2022 and therefore was incorporated into the Company's assessment of its ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. The Company's expectation to generate operating losses and negative operating cash flows in the future and the need for additional funding to support its planned operations raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date that these condensed consolidated financial statements are issued. Management's plans to alleviate the conditions that raise substantial doubt include implementing reduced 2022 spending, including projected savings through the move of the Company's headquarters to Assembly Row in Somerville, Massachusetts, the completion of its orderly wind down of European operations, the completion of its April 2022 restructuring plans, the potential sale of priority review vouchers that would be issued with the potential U.S. regulatory approvals of BLAs for beti-cel and/or eli-cel, and the pursuit of additional cash resources through public or private equity or debt financings. Management has concluded the likelihood that its plan to successfully obtain sufficient funding from one or more of these sources, or adequately reduce expenditures, while reasonably possible, is less than probable. In accordance with ASC 205-40, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of these condensed consolidated financial statements. |
Basis of presentation, principl
Basis of presentation, principles of consolidation and significant accounting policies | 6 Months Ended |
Jun. 30, 2022 | |
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”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as included in the ASC and Accounting Standards Updates (“ASUs”) 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, 2022 and 2021. 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, 2021, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission (the “SEC”) on March 4, 2022 (the "2021 Annual Report on Form 10-K"). Certain items in the prior year’s condensed consolidated financial statements have been reclassified to conform to the current presentation. The Company has presented its oncology business together with its manufacturing facility in Durham, North Carolina as discontinued operations in its consolidated financial statements for the three and six months ended June 30, 2021 (see Note 3, Discontinued operation s). The historical financial statements and footnotes have been recast accordingly. Amounts reported are computed based on thousands, except percentages, per share amounts or as otherwise noted. 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. 2seventy bio was a wholly-owned subsidiary until it became an independent publicly-traded company on November 4, 2021. All intercompany balances and transactions have been eliminated in consolidation. The Company views its operations and manages its business in one operating segment. Discontinued operations The Company determined that the separation of its oncology business in November 2021 and the sale of its manufacturing facility in Durham, North Carolina in September 2021 represented multiple components of a single disposal plan that met the criteria for classification as a discontinued operation in accordance with ASC Subtopic 205-20, Discontinued Operations (“ASC 205-20”). Accordingly, the accompanying condensed consolidated financial statements for the three and six months ended June 30, 2021 have been updated to present the results of all discontinued operations reported as a separate component of loss in the consolidated statements of operations and comprehensive loss (see Note 3, Discontinued operations ). 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, 2022 are consistent with those discussed in Note 2 to the consolidated financial statements included in the Company’s 2021 Annual Report on Form 10-K, except as noted in the "Recent accounting pronouncements - Not yet adopted" section below. 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 and judgments 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, stock-based compensation expense, accrued expenses, income taxes, the assets and liabilities and losses related to discontinued operations 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 Not yet adopted ASU No. 2022-02, Financial Instruments – Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures In March 2022, the FASB issued ASU 2022-02, Financial Instruments – Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures (“ASU 2022-02”), which eliminates the recognition and measurement guidance on troubled debt restructurings for creditors that have adopted ASC 326 and requires enhanced disclosure of loan modifications for borrowers experiencing financial difficulty. ASU 2022-02 amends the guidance on vintage disclosures to require disclosure of current-period gross write-offs by year of origination. The new standard will be effective beginning January 1, 2023. The adoption of ASU 2022-02 is not expected to have a material impact on the Company's financial position or results of operations. |
Discontinued operations
Discontinued operations | 6 Months Ended |
Jun. 30, 2022 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued operations | Discontinued operations Sale of bluebird Research Triangle manufacturing facility In November 2017, the Company acquired a manufacturing facility in Durham, North Carolina ("bRT") for the future manufacture of LVV for the Company’s therapies related to its oncology programs. In July 2021, the Company and Resilience US, Inc., an affiliate of National Resilience, Inc. ("Resilience"), signed an Asset Purchase Agreement (the “Agreement”). As part of the Agreement, and upon the closing of the transaction in September 2021, Resilience acquired the Company's LVV manufacturing facility located in Durham, North Carolina and retained staff currently employed at the site. As a result of the transaction, the Company disposed of $111.2 million of net assets, primarily consisting of the building and laboratory equipment associated with the Company's oncology programs. The Company recognized a loss on disposal of assets of $2.0 million during the year ended December 31, 2021. As the sale of the bRT manufacturing facility and the separation of 2seventy bio (as described below) were deemed to represent multiple components of a single disposal plan, the results of operations related to bRT have been included as a component of discontinued operations. 2seventy bio Separation On November 4, 2021, the Company completed the previously announced separation of its oncology programs and portfolio, and the certain related assets and liabilities, into a separate, independent publicly traded company (the “Separation”). The Separation was effected by means of a distribution of all of the outstanding shares of common stock of 2seventy bio in which each bluebird stockholder received one share of common stock, par value $0.0001 per share, of 2seventy bio for every three shares of common stock, par value $0.01 per share, of bluebird held as of the close of business on October 19, 2021 (the “Distribution”). In connection with the Separation, bluebird entered into a separation agreement (the “Separation Agreement”) with 2seventy bio, dated as of November 3, 2021, that, among other things, set forth bluebird’s agreements with 2seventy bio regarding the principal actions to be taken in connection with the Separation, including the Distribution. The effective time of the Distribution was 12:01 a.m. on November 4, 2021. The Separation Agreement identified assets transferred to, liabilities assumed by and contracts assigned to 2seventy bio as part of the Separation, and it provided for when and how these transfers, assumptions and assignments occurred. The purpose of the Separation Agreement was to provide 2seventy bio and bluebird with assets to operate their respective businesses and retain or assume liabilities related to those assets. Each of 2seventy bio and bluebird agreed to releases, with respect to pre-Separation claims, and cross indemnities, with respect to post-Separation claims, that were principally designed to place financial responsibility for the obligations and liabilities allocated to 2seventy bio under the Separation Agreement with 2seventy bio and financial responsibility for the obligations and liabilities allocated to bluebird under the Separation Agreement with bluebird. bluebird and 2seventy bio are also each subject to mutual 12-month employee non-solicit and non-hire restrictions, subject to certain customary exceptions. bluebird and 2seventy bio also entered into a tax matters agreement, an employee matters agreement and an intellectual property agreement. Additionally, bluebird entered into two transition services agreements with 2seventy bio, whose President is a member of the Company’s Board of Directors. Pursuant to the transition service agreements, bluebird is obligated to provide and is entitled to receive certain transition services related to corporate functions, such as finance, human resources, internal audit, research and development, financial reporting, and information technology. Services provided by bluebird to 2seventy bio will continue for an initial term of up to two years, unless earlier terminated or extended according to the terms of the transition services agreement. Services received and performed are paid at a mutually agreed upon rate. Amounts received for services provided to 2seventy bio are recorded as other income and amounts paid for services provided by 2seventy bio are recorded as selling, general and administrative expense and research and development expense, as applicable. In addition, the Company entered into a sublease agreement with 2seventy bio for office, laboratory and storage space located at 60 Binney Street (the "60 Binney Street Sublease") while it constructs and outfits its new office and laboratory space. During the three and six months ended June 30, 2022, the Company incurred $2.5 million and $5.5 million, respectively of net expense for transactions with 2seventy bio within research and development and selling, general and administrative expense in the condensed consolidated statements of operations and comprehensive loss, including $1.1 million and $2.3 million, respectively of net expense related to the 60 Binney Street Sublease. As of June 30, 2022, the Company had $0.4 million of accounts receivable due from and $2.9 million of accounts payable due to 2seventy bio. As of December 31, 2021, the Company had an immaterial amount of accounts receivable and accounts payable due from and due to 2seventy bio. Discontinued operations In connection with the Separation, the Company determined its oncology business, together with the bRT manufacturing facility, qualified for discontinued operations accounting treatment in accordance with ASC 205-20. The following table summarizes revenue and expenses of the discontinued operations for the three and six months ended June 30, 2021 (in thousands): Three months ended June 30, 2021 Six months ended June 30, 2021 Revenue: Service revenue $ 5,314 $ 11,232 Collaborative arrangement revenue 1,670 3,190 Royalty and other revenue 345 4,808 Total revenues 7,329 19,230 Operating expenses: Research and development 59,670 131,305 Selling, general and administrative 23,592 46,898 Share of collaboration loss 10,071 10,071 Cost of royalty and other revenue 86 1,791 Change in fair value of contingent consideration 47 416 Total operating expenses 93,466 190,481 Loss from operations (86,137) (171,251) Interest income, net 220 576 Other income, net 188 642 Loss before income taxes (85,729) (170,033) Income tax benefit (expense) — — Net loss $ (85,729) $ (170,033) There were no revenue and expenses of the discontinued operations for the three and six months ended June 30, 2022, as all operations were transferred to 2seventy bio upon the Separation. There were no assets and liabilities related to discontinued operations as of June 30, 2022 or December 31, 2021, as all balances were transferred to 2seventy bio upon the Separation. The following table summarizes the significant non-cash items and capital expenditures of the discontinued operations that are included in the condensed consolidated statements of cash flows for the six months ended June 30, 2021 (in thousands): Six months ended June 30, 2021 Operating activities: Change in fair value of contingent consideration $ 416 Depreciation and amortization 8,300 Stock-based compensation expense 19,104 Loss on fixed asset disposal 254 Investing activities: Purchase of property, plant and equipment $ (7,675) Purchase of intangible assets (2,000) Supplemental cash flow disclosures: Purchases of property, plant and equipment included in accounts payable and accrued expenses $ 1,345 Purchases of intangible assets included in accounts payable and accrued expenses, net of reimbursement receivable from collaboration partner 6,500 |
Marketable securities
Marketable securities | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable securities | Marketable securities The following table summarizes the marketable securities held at June 30, 2022 and December 31, 2021 (in thousands): Description Amortized cost / Cost Unrealized gains Unrealized losses Fair value June 30, 2022 U.S. government agency securities and treasuries $ 77,943 $ — $ (1,980) $ 75,963 Corporate bonds 13,294 (105) 13,189 Commercial paper 2,499 — — 2,499 Equity securities — — — — Total $ 93,736 $ — $ (2,085) $ 91,651 December 31, 2021 U.S. government agency securities and treasuries $ 128,902 $ — $ (509) $ 128,393 Corporate bonds 49,366 — (59) 49,307 Commercial paper 54,065 — — 54,065 Equity securities 4,305 — (614) 3,691 Total $ 236,638 $ — $ (1,182) $ 235,456 No available-for-sale debt securities held as of June 30, 2022 or December 31, 2021 had remaining maturities greater than five years. |
Fair value measurements
Fair value measurements | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 and December 31, 2021 (in thousands): Description Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) June 30, 2022 Assets: Cash and cash equivalents $ 81,499 $ 81,499 $ — $ — Marketable securities: U.S. government agency securities and treasuries 75,963 — 75,963 — Corporate bonds 13,189 — 13,189 — Commercial paper 2,499 — 2,499 — Equity securities — — — — Total $ 173,150 $ 81,499 $ 91,651 $ — December 31, 2021 Assets: Cash and cash equivalents $ 161,160 $ 161,146 $ 14 $ — Marketable securities: U.S. government agency securities and treasuries 128,393 — 128,393 — Corporate bonds 49,308 — 49,308 — Commercial paper 54,065 — 54,065 — Equity securities 3,691 3,691 — — Total $ 396,617 $ 164,837 $ 231,780 $ — 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, 2022 and December 31, 2021, cash and cash equivalents comprise funds in cash and money market accounts. Marketable securities Marketable securities classified as Level 2 within the valuation hierarchy generally consist of U.S. government agency securities and treasuries, 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, 2022 and December 31, 2021, the balance in the Company’s accumulated other comprehensive loss was composed primarily of 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 debt securities during the three and six months ended June 30, 2022 or 2021. Accrued interest receivable on the Company's available-for-sale debt securities totaled $0.1 million and $0.3 million as of June 30, 2022 and December 31, 2021, respectively. No accrued interest receivable was written off during the three and six months ended June 30, 2022 or 2021. 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, 2022 and December 31, 2021 (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, 2022 U.S. government agency securities $ 68,129 $ (1,814) $ 7,834 $ (166) $ 75,963 $ (1,980) Corporate bonds 6,672 (79) 6,517 (26) 13,189 (105) Total $ 74,801 $ (1,893) $ 14,351 $ (192) $ 89,152 $ (2,085) December 31, 2021 U.S. government agency securities $ 108,695 $ (505) $ 2,496 $ (4) $ 111,191 $ (509) Corporate bonds 45,042 (56) 3,896 (2) 48,938 (58) Total $ 153,737 $ (561) $ 6,392 $ (6) $ 160,129 $ (567) The Company determined that there was no material change in the credit risk of the above investments during the six months ended June 30, 2022. As such, an allowance for credit losses was not recognized. In April 2022, the Company sold securities with a carrying value of $29.7 million and realized net aggregate losses of $0.4 million. As of June 30, 2022, the Company does not intend to sell such securities before recovery of their amortized cost bases. |
Property, plant and equipment,
Property, plant and equipment, net | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 As of December 31, 2021 Laboratory equipment $ 28,838 $ 29,061 Computer equipment and software 1,733 421 Office equipment 5,679 117 Leasehold improvements — 12 Construction-in-progress 817 501 Total property, plant and equipment 37,067 30,112 Less accumulated depreciation and amortization (22,501) (20,406) Property, plant and equipment, net $ 14,566 $ 9,706 |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 As of December 31, 2021 Accrued manufacturing costs $ 18,530 $ 15,722 Accrued goods and services 14,567 24,273 Accrued clinical and contract research organization costs 18,069 17,769 Accrued employee compensation 19,853 41,095 Accrued professional fees 1,226 1,665 Deferred revenue, current portion 1,635 2,282 Other 1,670 1,152 Total accrued expenses and other current liabilities $ 75,550 $ 103,958 Accrued employee compensation as of December 31, 2021 includes severance costs associated with the Company's orderly wind down of its European operations. In April 2022, the Company announced a restructuring which included a reduction in force. As of June 30, 2022, the Company had $2.7 million of accrued employee compensation related to the April 2022 restructuring. Please refer to Note 14, Reduction in workforce, for further information. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | Leases The Company leases certain office and laboratory space, primarily located in Cambridge, Massachusetts and Somerville, Massachusetts. Additionally, the Company has embedded leases through its agreements with contract manufacturing organizations in both the United States and internationally. Except as described below, there have been no material changes in lease obligations from those disclosed in Note 10 to the consolidated financial statements included in the Company's 2021 Annual Report on Form 10-K. Assembly Row lease In November 2021, the Company entered into a lease agreement with Assembly Row 5B, LLC ("Landlord") for office space located at 455 Grand Union Boulevard in Somerville, Massachusetts to serve as the Company's future corporate headquarters (the “Assembly Row Lease”). Upon signing the Assembly Row Lease, the Company executed a $2.8 million letter of credit for the Landlord’s benefit, which is classified as restricted cash and other non-current assets on the Company’s condensed consolidated balance sheets. In March 2022, the Assembly Row Lease commenced upon the Landlord granting the Company control of the leased premises. The Assembly Row Lease will continue until December 31, 2032, with an option to extend for two additional five-year terms. The Company classified the Assembly Row Lease as an operating lease and recognized a right-of-use asset and lease liability upon lease commencement. The Company will recognize rent expense on a straight-line basis throughout the remaining term of the Assembly Row Lease. 50 Binney Street lease & sublease In April 2019, the Company entered into an agreement to lease office space located at 50 Binney Street in Cambridge, Massachusetts (the “50 Binney Street Lease”). In December 2021, the Company entered into an agreement to sublease the entire office space to Meta Platforms, Inc. (“Meta”) (the "Sublease"). In April 2022, both the 50 Binney Street Lease and the Sublease commenced upon the landlord granting access to the leased premises. In connection with the execution of the 50 Binney Street Lease, the Company also entered into a purchase agreement with the landlord for furniture and equipment (the “Furniture Purchase Agreement”) located on the premises upon lease commencement. Upon execution of the Furniture Purchase Agreement, the Company made an upfront payment of $7.5 million. Upon lease commencement, the Company paid the remaining $7.25 million due under the Furniture Purchase Agreement. The fair value of the furniture is $2.4 million, and the remaining excess of the $7.25 million payment over fair value will be recognized as expense over the life of the lease. The Company classified the 50 Binney Street Lease as an operating lease and recognized the right-of-use asset and lease liability upon lease commencement. The Company will recognize rent expense on a straight-line basis throughout the remaining term of the 50 Binney Street Lease. The Sublease will continue until December 31, 2030. The Company classified the 50 Binney Street Sub-lease as an operating lease. The Company will earn rental income through its role as a lessor throughout the term of the Sublease. The |
Commitments and contingencies
Commitments and contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies 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. 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. 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 2021 Annual Report on Form 10-K, the Company's future minimum purchase commitments as of the six months ended June 30, 2022 decreased by $23.0 million. 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, including securities class action litigation. 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 generally 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 officers and directors 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 such officer or director may be subject to any proceeding arising out of acts or omissions of such officer or director 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. |
Equity
Equity | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Equity | Equity On June 22, 2022, the Company entered into the Equity Distribution Agreement with Goldman to sell shares of the Company’s common stock, with aggregate gross sales proceeds of up to $75.0 million, from time to time, through an “at the market” equity offering program under which Goldman will act as manager. The Equity Distribution Agreement also provides for the sale of shares to Goldman directly as principal, in which case the Company and Goldman will enter into a separate term agreement. Under the Equity Distribution Agreement, the Company will set the parameters for the sale of shares, including any price, time or size limits or other customary parameters or conditions. The Company intends to sell shares pursuant to the Equity Distribution Agreement from time to time in varying amounts, which may be limited, based upon factors including (among others) market conditions, trading liquidity, the trading price of the Company’s common stock, and determinations by the Company of its need for, and appropriate sources of, additional capital. Subject to the terms and conditions of the Equity Distribution Agreement, Goldman may sell the shares by any method permitted by law, including without limitation (i) by means of ordinary brokers’ transactions (whether or not solicited), (ii) to or through a market maker, (iii) directly on or through any national securities exchange or facility thereof, a trading facility of a national securities association, an alternative trading system, or any other market venue, (iv) in the over-the-counter market, (v) in privately negotiated transactions, or (vi) through a combination of any such methods. The Company will pay Goldman a commission equal to up to 3.0% of the gross proceeds of any common stock sold through Goldman under the Equity Distribution Agreement, and also has provided Goldman with customary representations, warranties, covenants and indemnification rights. The Equity Distribution Agreement may be terminated by the Company upon written notice to Goldman or by Goldman upon written notice to the Company. In the case of any purchase of shares by Goldman directly as principal pursuant to a Terms Agreement, such Terms Agreement may be terminated by Goldman upon notice to the Company under certain circumstances, including but not limited to the occurrence of a material adverse effect in the Company. In the three months ended June 30, 2022, the Company has sold 2.1 million shares of common stock for gross proceeds of $8.3 million ($8.0 million net of offering costs). |
Stock-based compensation
Stock-based compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based compensation | Stock-based compensation In January 2022 and 2021, the number of shares of common stock available for issuance under the 2013 Stock Option and Incentive Plan (“2013 Plan”) was increased by approximately 2.8 million and 2.7 million shares, respectively, as a result of the automatic increase provision of the 2013 Plan. As of June 30, 2022, the total number of shares of common stock available for issuance under the 2013 Plan was approximately 4.7 million. Stock-based compensation expense The Company recognized stock-based compensation expense totaling $8.9 million and $23.1 million during the three months ended June 30, 2022 and 2021, respectively. The Company recognized stock based compensation expense totaling $21.3 million and $54.4 million on for the six months ended June 30, 2022 and 2021, respectively. Stock-based compensation expense recognized by award type is included within the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): For the three months ended June 30, For six months ended June 30, 2022 2021 (1) 2022 2021 (1) Stock options $ 3,685 $ 13,863 $ 8,945 $ 30,289 Restricted stock units 4,850 5,956 11,884 16,173 Employee stock purchase plan and other 372 3,307 469 7,958 $ 8,907 $ 23,126 $ 21,298 $ 54,420 (1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation. 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 six months ended June 30, 2022 2021 (1) 2022 2021 (1) Research and development $ 5,255 $ 10,336 $ 11,810 $ 22,726 Selling, general and administrative 3,652 12,790 9,488 31,694 $ 8,907 $ 23,126 $ 21,298 $ 54,420 (1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation. Stock options The following table summarizes the stock option activity under the Company’s equity award plans and have been adjusted to reflect the effects of the Separation: Shares (in thousands) Weighted- average exercise price per share Outstanding at December 31, 2021 3,586 $ 39.23 Granted 967 $ 7.48 Exercised (2) $ 1.04 Canceled or forfeited (1,482) $ 41.11 Outstanding at June 30, 2022 3,069 $ 29.48 Exercisable at June 30, 2022 1,296 $ 51.24 Vested and expected to vest at June 30, 2022 3,069 $ 29.48 During the six months ended June 30, 2022, less than 0.1 million stock options were exercised, resulting in total proceeds to the Company of less than $0.1 million. Restricted stock units The following table summarizes the restricted stock unit activity under the Company’s equity award plans and have been adjusted to reflect the effects of the Separation: Shares Weighted- Unvested at December 31, 2021 3,193 $ 16.21 Granted 1,451 $ 7.51 Vested (293) $ 25.65 Forfeited (1,076) $ 12.67 Unvested at June 30, 2022 3,275 $ 12.70 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. In June 2021, the Company amended the 2013 ESPP to authorize an additional 1.4 million shares of the Company’s common stock available to participating employees. During each of the six months ended June 30, 2022 and 2021, no shares and less than 0.1 million shares, respectively, of common stock were issued under the 2013 ESPP. |
Income taxes
Income taxes | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 is immaterial due to the wind down of our operations in Europe. In March 2021, the American Rescue Plan Act (“ARPA”) was enacted and contained extenders to the refundable employee retention credit and provided further limitations to executive compensation effective for tax years beginning after 2026. The Company has concluded that the provisions in the CARES Act, Consolidated Appropriations Act, and ARPA have an immaterial impact on the Company’s income tax expense due to its cumulative losses and full valuation allowance position. |
Net loss per share
Net loss per share | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 Outstanding stock options (1) 4,958 6,099 Restricted stock units (1) 3,408 1,865 ESPP shares and other 264 746 8,630 8,710 |
Restructuring
Restructuring | 6 Months Ended |
Jun. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | Restructuring In April 2022, the Board of Directors of the Company approved a comprehensive restructuring plan intended to reduce operating expenses. The Company intends to maintain targeted research efforts focused on in-vivo LVV gene therapy and to deprioritize direct investments in reduced toxicity conditioning and cryopreserved apheresis. As part of the restructuring, the Company plans to reduce its workforce by 30% across the second and third quarters of 2022. The Company estimates that it will incur approximately $6.6 million in costs to implement the restructuring, comprised primarily of severance payments and continuing health care coverage over the severance period. The restructuring actions associated with these charges commenced in April 2022, and are expected to be substantially completed by the end of 2022. The following table summarizes the accrued liabilities activity recorded in connection with the restructuring for the three and six months ended June 30, 2022: As of June 30, 2022 Beginning balance $ — Total expense $ 6,639 Payments made from inception through June 30, 2022 $ 3,989 Remaining accrual at June 30, 2022 $ 2,650 |
Subsequent events
Subsequent events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent events | Subsequent events The Company has raised approximately additional gross proceeds of $24.7 million and issued 5.5 million shares of common stock under the Equity Distribution Agreement through the date of this report. Of this $24.7 million, $8.0 million in net proceeds were realized in the second quarter of 2022 and are reflected in the restricted cash, cash and cash equivalents and marketable securities balances as of June 30, 2022. Please refer to Note 10, Equity, for further information. |
Basis of presentation, princi_2
Basis of presentation, principles of consolidation and significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
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”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as included in the ASC and Accounting Standards Updates (“ASUs”) 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, 2022 and 2021. |
Consolidation | The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. 2seventy bio was a wholly-owned subsidiary until it became an independent publicly-traded company on November 4, 2021. All intercompany balances and transactions have been eliminated in consolidation. The Company views its operations and manages its business in one operating segment. |
Discontinued operations | Discontinued operations The Company determined that the separation of its oncology business in November 2021 and the sale of its manufacturing facility in Durham, North Carolina in September 2021 represented multiple components of a single disposal plan that met the criteria for classification as a discontinued operation in accordance with ASC Subtopic 205-20, Discontinued Operations (“ASC 205-20”). Accordingly, the accompanying condensed consolidated financial statements for the three and six months ended June 30, 2021 have been updated to present the results of all discontinued operations reported as a separate component of loss in the consolidated statements of operations and comprehensive loss (see Note 3, Discontinued operations ). |
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 and judgments 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, stock-based compensation expense, accrued expenses, income taxes, the assets and liabilities and losses related to discontinued operations 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 Not yet adopted ASU No. 2022-02, Financial Instruments – Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures In March 2022, the FASB issued ASU 2022-02, Financial Instruments – Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures (“ASU 2022-02”), which eliminates the recognition and measurement guidance on troubled debt restructurings for creditors that have adopted ASC 326 and requires enhanced disclosure of loan modifications for borrowers experiencing financial difficulty. ASU 2022-02 amends the guidance on vintage disclosures to require disclosure of current-period gross write-offs by year of origination. The new standard will be effective beginning January 1, 2023. The adoption of ASU 2022-02 is not expected to have a material impact on the Company's financial position or results of operations. |
Discontinued operations (Tables
Discontinued operations (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Summary of Revenues , Expenses, Non-cash Items and Capital Expenditures for Discontinued Operations | The following table summarizes revenue and expenses of the discontinued operations for the three and six months ended June 30, 2021 (in thousands): Three months ended June 30, 2021 Six months ended June 30, 2021 Revenue: Service revenue $ 5,314 $ 11,232 Collaborative arrangement revenue 1,670 3,190 Royalty and other revenue 345 4,808 Total revenues 7,329 19,230 Operating expenses: Research and development 59,670 131,305 Selling, general and administrative 23,592 46,898 Share of collaboration loss 10,071 10,071 Cost of royalty and other revenue 86 1,791 Change in fair value of contingent consideration 47 416 Total operating expenses 93,466 190,481 Loss from operations (86,137) (171,251) Interest income, net 220 576 Other income, net 188 642 Loss before income taxes (85,729) (170,033) Income tax benefit (expense) — — Net loss $ (85,729) $ (170,033) Six months ended June 30, 2021 Operating activities: Change in fair value of contingent consideration $ 416 Depreciation and amortization 8,300 Stock-based compensation expense 19,104 Loss on fixed asset disposal 254 Investing activities: Purchase of property, plant and equipment $ (7,675) Purchase of intangible assets (2,000) Supplemental cash flow disclosures: Purchases of property, plant and equipment included in accounts payable and accrued expenses $ 1,345 Purchases of intangible assets included in accounts payable and accrued expenses, net of reimbursement receivable from collaboration partner 6,500 |
Marketable securities (Tables)
Marketable securities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Marketable Securities Held | The following table summarizes the marketable securities held at June 30, 2022 and December 31, 2021 (in thousands): Description Amortized cost / Cost Unrealized gains Unrealized losses Fair value June 30, 2022 U.S. government agency securities and treasuries $ 77,943 $ — $ (1,980) $ 75,963 Corporate bonds 13,294 (105) 13,189 Commercial paper 2,499 — — 2,499 Equity securities — — — — Total $ 93,736 $ — $ (2,085) $ 91,651 December 31, 2021 U.S. government agency securities and treasuries $ 128,902 $ — $ (509) $ 128,393 Corporate bonds 49,366 — (59) 49,307 Commercial paper 54,065 — — 54,065 Equity securities 4,305 — (614) 3,691 Total $ 236,638 $ — $ (1,182) $ 235,456 |
Fair value measurements (Tables
Fair value measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 and December 31, 2021 (in thousands): Description Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) June 30, 2022 Assets: Cash and cash equivalents $ 81,499 $ 81,499 $ — $ — Marketable securities: U.S. government agency securities and treasuries 75,963 — 75,963 — Corporate bonds 13,189 — 13,189 — Commercial paper 2,499 — 2,499 — Equity securities — — — — Total $ 173,150 $ 81,499 $ 91,651 $ — December 31, 2021 Assets: Cash and cash equivalents $ 161,160 $ 161,146 $ 14 $ — Marketable securities: U.S. government agency securities and treasuries 128,393 — 128,393 — Corporate bonds 49,308 — 49,308 — Commercial paper 54,065 — 54,065 — Equity securities 3,691 3,691 — — Total $ 396,617 $ 164,837 $ 231,780 $ — |
Summary of Available-for-sale Debt Securities in Continuous Unrealized Loss Position | 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, 2022 and December 31, 2021 (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, 2022 U.S. government agency securities $ 68,129 $ (1,814) $ 7,834 $ (166) $ 75,963 $ (1,980) Corporate bonds 6,672 (79) 6,517 (26) 13,189 (105) Total $ 74,801 $ (1,893) $ 14,351 $ (192) $ 89,152 $ (2,085) December 31, 2021 U.S. government agency securities $ 108,695 $ (505) $ 2,496 $ (4) $ 111,191 $ (509) Corporate bonds 45,042 (56) 3,896 (2) 48,938 (58) Total $ 153,737 $ (561) $ 6,392 $ (6) $ 160,129 $ (567) |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 As of December 31, 2021 Laboratory equipment $ 28,838 $ 29,061 Computer equipment and software 1,733 421 Office equipment 5,679 117 Leasehold improvements — 12 Construction-in-progress 817 501 Total property, plant and equipment 37,067 30,112 Less accumulated depreciation and amortization (22,501) (20,406) Property, plant and equipment, net $ 14,566 $ 9,706 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 As of December 31, 2021 Accrued manufacturing costs $ 18,530 $ 15,722 Accrued goods and services 14,567 24,273 Accrued clinical and contract research organization costs 18,069 17,769 Accrued employee compensation 19,853 41,095 Accrued professional fees 1,226 1,665 Deferred revenue, current portion 1,635 2,282 Other 1,670 1,152 Total accrued expenses and other current liabilities $ 75,550 $ 103,958 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock-Based Compensation Expense by Award Type | Stock-based compensation expense recognized by award type is included within the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): For the three months ended June 30, For six months ended June 30, 2022 2021 (1) 2022 2021 (1) Stock options $ 3,685 $ 13,863 $ 8,945 $ 30,289 Restricted stock units 4,850 5,956 11,884 16,173 Employee stock purchase plan and other 372 3,307 469 7,958 $ 8,907 $ 23,126 $ 21,298 $ 54,420 |
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 six months ended June 30, 2022 2021 (1) 2022 2021 (1) Research and development $ 5,255 $ 10,336 $ 11,810 $ 22,726 Selling, general and administrative 3,652 12,790 9,488 31,694 $ 8,907 $ 23,126 $ 21,298 $ 54,420 |
Summary of Stock Option Activity Under Plan | The following table summarizes the stock option activity under the Company’s equity award plans and have been adjusted to reflect the effects of the Separation: Shares (in thousands) Weighted- average exercise price per share Outstanding at December 31, 2021 3,586 $ 39.23 Granted 967 $ 7.48 Exercised (2) $ 1.04 Canceled or forfeited (1,482) $ 41.11 Outstanding at June 30, 2022 3,069 $ 29.48 Exercisable at June 30, 2022 1,296 $ 51.24 Vested and expected to vest at June 30, 2022 3,069 $ 29.48 |
Summary of Restricted Common Stock Awards | The following table summarizes the restricted stock unit activity under the Company’s equity award plans and have been adjusted to reflect the effects of the Separation: Shares Weighted- Unvested at December 31, 2021 3,193 $ 16.21 Granted 1,451 $ 7.51 Vested (293) $ 25.65 Forfeited (1,076) $ 12.67 Unvested at June 30, 2022 3,275 $ 12.70 |
Net loss per share (Tables)
Net loss per share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 Outstanding stock options (1) 4,958 6,099 Restricted stock units (1) 3,408 1,865 ESPP shares and other 264 746 8,630 8,710 |
Restructuring (Tables)
Restructuring (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Summary of Accrued Liability Activity Recorded in Connection with Reduction in Workforce | The following table summarizes the accrued liabilities activity recorded in connection with the restructuring for the three and six months ended June 30, 2022: As of June 30, 2022 Beginning balance $ — Total expense $ 6,639 Payments made from inception through June 30, 2022 $ 3,989 Remaining accrual at June 30, 2022 $ 2,650 |
Description of the business (De
Description of the business (Detail) - USD ($) $ in Thousands, shares in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||
Jun. 30, 2022 | Jun. 22, 2022 | Apr. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | ||||||||||
Cash, cash equivalents and marketable securities | $ 173,200 | $ 173,200 | $ 173,200 | |||||||
Accumulated deficit | 3,942,215 | 3,942,215 | 3,942,215 | $ 3,719,925 | ||||||
Net loss | 100,138 | $ 122,152 | $ 241,702 | $ 205,808 | 222,290 | $ 447,510 | ||||
Net cash used in operating activities | $ (219,654) | $ (348,975) | ||||||||
Private Placement | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Proceeds from stock offering | $ 8,300 | $ 8,300 | ||||||||
Commission fee, percentage of gross proceeds (up to) | 3% | |||||||||
Shares of common stock sold (in shares) | 2.1 | 2.1 | ||||||||
Offering costs | $ 8,000 | $ 8,000 | ||||||||
Maximum | Private Placement | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Proceeds from stock offering | $ 75,000 | |||||||||
April 2022 Reduction | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Plans to reduce workforce, as a percent | 30% |
Basis of presentation, princi_3
Basis of presentation, principles of consolidation and significant accounting policies (Detail) | 6 Months Ended |
Jun. 30, 2022 segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Discontinued operations - Narra
Discontinued operations - Narrative (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2022 USD ($) $ / shares | Jun. 30, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) $ / shares | Nov. 04, 2021 $ / shares | Nov. 03, 2021 agreement | Sep. 30, 2021 USD ($) | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Conversion ratio | 0.3333 | |||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||
Number of transition services agreements | agreement | 2 | |||||
Initial term of transition services agreement | 2 years | |||||
Lentiviral Vector Manufacturing Facility | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Net assets transferred to 2seventy bio | $ 111.2 | |||||
Loss on fixed assets disposal | $ 2 | |||||
2seventy bio | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||
Selling, general and administrative expense related to transition services agreement | $ 2.5 | $ 5.5 | ||||
Accounts receivable due from related party | 0.4 | 0.4 | ||||
Accounts payable to related party | 2.9 | 2.9 | ||||
2seventy bio | 60 Binney Street Lease | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Related party expense | $ 1.1 | $ 2.3 |
Discontinued operations - Reven
Discontinued operations - Revenue and Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Net loss | $ 0 | $ (85,729) | $ 0 | $ (170,033) |
2seventy bio | Discontinued Operations, Disposed of by Means Other than Sale, Spinoff | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | 7,329 | 19,230 | ||
Research and development | 59,670 | 131,305 | ||
Selling, general and administrative | 23,592 | 46,898 | ||
Share of collaboration loss | 10,071 | 10,071 | ||
Change in fair value of contingent consideration | 47 | 416 | ||
Total operating expenses | 93,466 | 190,481 | ||
Loss from operations | (86,137) | (171,251) | ||
Interest income, net | 220 | 576 | ||
Other income, net | 188 | 642 | ||
Loss before income taxes | (85,729) | (170,033) | ||
Income tax benefit (expense) | 0 | 0 | ||
Net loss | (85,729) | (170,033) | ||
2seventy bio | Discontinued Operations, Disposed of by Means Other than Sale, Spinoff | Service revenue | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | 5,314 | 11,232 | ||
2seventy bio | Discontinued Operations, Disposed of by Means Other than Sale, Spinoff | Collaborative arrangement revenue | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | 1,670 | 3,190 | ||
2seventy bio | Discontinued Operations, Disposed of by Means Other than Sale, Spinoff | Other revenue | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | 345 | 4,808 | ||
Cost of royalty and other revenue | $ 86 | $ 1,791 |
Discontinued operations - Signi
Discontinued operations - Significant Non-Cash Items and Capital Expenditures (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities: | ||
Change in fair value of contingent consideration | $ 0 | $ 416 |
Stock-based compensation expense | 21,298 | 73,687 |
Investing activities: | ||
Purchase of property, plant and equipment | (6,836) | (9,204) |
Purchase of intangible assets | 0 | (2,000) |
Supplemental cash flow disclosures: | ||
Purchases of property, plant and equipment included in accounts payable and accrued expenses | $ 842 | 1,508 |
Discontinued Operations, Disposed of by Means Other than Sale, Spinoff | 2seventy bio | ||
Operating activities: | ||
Change in fair value of contingent consideration | 416 | |
Depreciation and amortization | 8,300 | |
Stock-based compensation expense | 19,104 | |
Loss on fixed assets disposal | 254 | |
Investing activities: | ||
Purchase of property, plant and equipment | (7,675) | |
Purchase of intangible assets | (2,000) | |
Supplemental cash flow disclosures: | ||
Purchases of property, plant and equipment included in accounts payable and accrued expenses | 1,345 | |
Purchases of intangible assets included in accounts payable and accrued expenses, net of reimbursement receivable from collaboration partner | $ 6,500 |
Marketable securities (Detail)
Marketable securities (Detail) - USD ($) | Jun. 30, 2022 | Apr. 30, 2022 | Dec. 31, 2021 |
Amortized cost / Cost | |||
Equity securities | $ 0 | $ 4,305,000 | |
Marketable securities | 93,736,000 | 236,638,000 | |
Unrealized gains | |||
Equity securities | 0 | 0 | |
Marketable securities | 0 | 0 | |
Unrealized losses | |||
Equity securities | 0 | (614,000) | |
Marketable securities | (2,085,000) | (1,182,000) | |
Fair value | |||
Debt securities | $ 29,700,000 | ||
Equity securities | 0 | 3,691,000 | |
Marketable securities | 91,651,000 | 235,456,000 | |
Debt securities, available-for-sale, noncurrent | 0 | 0 | |
U.S. government agency securities and treasuries | |||
Amortized cost / Cost | |||
Debt securities | 77,943,000 | 128,902,000 | |
Unrealized gains | |||
Debt securities | 0 | 0 | |
Unrealized losses | |||
Debt securities | (1,980,000) | (509,000) | |
Fair value | |||
Debt securities | 75,963,000 | 128,393,000 | |
Corporate bonds | |||
Amortized cost / Cost | |||
Debt securities | 13,294,000 | 49,366,000 | |
Unrealized gains | |||
Debt securities | 0 | ||
Unrealized losses | |||
Debt securities | (105,000) | (59,000) | |
Fair value | |||
Debt securities | 13,189,000 | 49,307,000 | |
Commercial paper | |||
Amortized cost / Cost | |||
Debt securities | 2,499,000 | 54,065,000 | |
Unrealized gains | |||
Debt securities | 0 | 0 | |
Unrealized losses | |||
Debt securities | 0 | 0 | |
Fair value | |||
Debt securities | $ 2,499,000 | $ 54,065,000 |
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, 2022 | Dec. 31, 2021 |
Assets: | ||
Marketable securities: | $ 91,651 | $ 235,456 |
Equity securities | 0 | 3,691 |
Fair Value, Measurements, Recurring | ||
Assets: | ||
Cash and cash equivalents | 81,499 | 161,160 |
Equity securities | 0 | 3,691 |
Total | 173,150 | 396,617 |
Fair Value, Measurements, Recurring | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 75,963 | 128,393 |
Fair Value, Measurements, Recurring | Corporate bonds | ||
Assets: | ||
Marketable securities: | 13,189 | 49,308 |
Fair Value, Measurements, Recurring | Commercial paper | ||
Assets: | ||
Marketable securities: | 2,499 | 54,065 |
Fair Value, Measurements, Recurring | Quoted prices in active markets (Level 1) | ||
Assets: | ||
Cash and cash equivalents | 81,499 | 161,146 |
Equity securities | 0 | 3,691 |
Total | 81,499 | 164,837 |
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) | 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 | 14 |
Equity securities | 0 | 0 |
Total | 91,651 | 231,780 |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 75,963 | 128,393 |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | Corporate bonds | ||
Assets: | ||
Marketable securities: | 13,189 | 49,308 |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | Commercial paper | ||
Assets: | ||
Marketable securities: | 2,499 | 54,065 |
Fair Value, Measurements, Recurring | Significant unobservable inputs (Level 3) | ||
Assets: | ||
Cash and cash equivalents | 0 | 0 |
Equity securities | 0 | 0 |
Total | 0 | 0 |
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) | 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 ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
May 31, 2022 | Apr. 30, 2022 | Jan. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Realized gain (loss) on available-for-sale securities | $ 400,000 | $ 0 | $ 0 | $ 0 | $ 0 | |||
Interest receivable | 100,000 | 100,000 | $ 300,000 | |||||
Interest receivable, write-offs | 0 | 0 | 0 | 0 | ||||
Debt securities | $ 29,700,000 | |||||||
Investment at fair value | 0 | 0 | $ 3,691,000 | |||||
Proceeds from sale of equity securities | $ 600,000 | $ 31,300,000 | ||||||
Equity securities, gain (loss) | (3,135,000) | 28,286,000 | ||||||
Other (Expense) Income, Net | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Equity securities, gain (loss) | $ (600,000) | $ (100,000) | $ (3,100,000) | $ (28,300,000) |
Fair value measurements - Sched
Fair value measurements - Schedule of Unrealized Loss on Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair value | ||
Less than 12 months | $ 74,801 | $ 153,737 |
12 months or greater | 14,351 | 6,392 |
Total | 89,152 | 160,129 |
Unrealized losses | ||
Less than 12 months | (1,893) | (561) |
12 months or greater | (192) | (6) |
Total | (2,085) | (567) |
U.S. government agency securities and treasuries | ||
Fair value | ||
Less than 12 months | 68,129 | 108,695 |
12 months or greater | 7,834 | 2,496 |
Total | 75,963 | 111,191 |
Unrealized losses | ||
Less than 12 months | (1,814) | (505) |
12 months or greater | (166) | (4) |
Total | (1,980) | (509) |
Corporate bonds | ||
Fair value | ||
Less than 12 months | 6,672 | 45,042 |
12 months or greater | 6,517 | 3,896 |
Total | 13,189 | 48,938 |
Unrealized losses | ||
Less than 12 months | (79) | (56) |
12 months or greater | (26) | (2) |
Total | $ (105) | $ (58) |
Property, plant and equipment_3
Property, plant and equipment, net - Summary of Property, Plant and Equipment Net (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | $ 37,067 | $ 30,112 |
Less accumulated depreciation and amortization | (22,501) | (20,406) |
Property, plant and equipment, net | 14,566 | 9,706 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 28,838 | 29,061 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 1,733 | 421 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 5,679 | 117 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | 0 | 12 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | $ 817 | $ 501 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued manufacturing costs | $ 18,530 | $ 15,722 |
Accrued goods and services | 14,567 | 24,273 |
Accrued clinical and contract research organization costs | 18,069 | 17,769 |
Accrued employee compensation | 19,853 | 41,095 |
Accrued professional fees | 1,226 | 1,665 |
Deferred revenue, current portion | 1,635 | 2,282 |
Other | 1,670 | 1,152 |
Total accrued expenses and other current liabilities | $ 75,550 | $ 103,958 |
Accrued expenses and other cu_4
Accrued expenses and other current liabilities - Narrative (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Restructuring Cost and Reserve [Line Items] | ||
Accrued employee compensation | $ 19,853 | $ 41,095 |
April 2022 Restructuring | ||
Restructuring Cost and Reserve [Line Items] | ||
Accrued employee compensation | $ 2,700 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands | 1 Months Ended | 6 Months Ended | |||
Mar. 31, 2022 renewalOption | Nov. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Apr. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Lessee, Lease, Description [Line Items] | |||||
Fair value of furniture | $ 14,566 | $ 9,706 | |||
Sublease income | $ 7,500 | ||||
Assembly Row Lease | |||||
Lessee, Lease, Description [Line Items] | |||||
Number of lease renewal options | renewalOption | 2 | ||||
Lease renewal term | 5 years | ||||
Collateralized letter of credit | $ 2,800 | ||||
50 Binney Street Sublease | |||||
Lessee, Lease, Description [Line Items] | |||||
Upfront payment for purchase of furniture and equipment | $ 7,500 | ||||
Payment for purchase of furniture and equipment, upon lease commencement | 7,250 | ||||
Fair value of furniture | $ 2,400 |
Commitments and contingencies (
Commitments and contingencies (Detail) $ in Millions | Jun. 30, 2022 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Decrease in purchase commitments | $ 23 |
Equity (Details)
Equity (Details) - Private Placement - USD ($) shares in Millions, $ in Millions | 3 Months Ended | ||
Jun. 30, 2022 | Jun. 22, 2022 | Jun. 30, 2022 | |
Subsidiary, Sale of Stock [Line Items] | |||
Proceeds from stock offering (up to) | $ 8.3 | $ 8.3 | |
Commission fee, percentage of gross proceeds (up to) | 3% | ||
Shares of common stock sold (in shares) | 2.1 | 2.1 | |
Offering costs | $ 8 | $ 8 | |
Maximum | |||
Subsidiary, Sale of Stock [Line Items] | |||
Proceeds from stock offering (up to) | $ 75 |
Stock-based compensation - Narr
Stock-based compensation - Narrative (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jan. 31, 2022 | Jan. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | 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) | 2,800,000 | 2,700,000 | |||||
Number of shares available for issuance (in shares) | 4,700,000 | 4,700,000 | |||||
Stock-based compensation expense | $ 8,907 | $ 23,126 | $ 21,298 | $ 54,420 | |||
Stock option share exercised (in shares) | 2,000 | ||||||
Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock option share exercised (in shares) | 100,000 | ||||||
Proceed from option share exercised | $ 100 | ||||||
Stock options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation expense | 3,685 | 13,863 | 8,945 | 30,289 | |||
ESPP shares and other | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation expense | $ 372 | $ 3,307 | $ 469 | $ 7,958 | |||
Common shares reserved for future issuance (in shares) | 200,000 | ||||||
Increase in shares authorized (in shares) | 1,400,000 | 1,400,000 | |||||
ESPP shares and other | Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock issued under plan (in shares) | 0 | 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, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 8,907 | $ 23,126 | $ 21,298 | $ 54,420 |
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 3,685 | 13,863 | 8,945 | 30,289 |
Restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 4,850 | 5,956 | 11,884 | 16,173 |
Employee stock purchase plan and other | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 372 | $ 3,307 | $ 469 | $ 7,958 |
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, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 8,907 | $ 23,126 | $ 21,298 | $ 54,420 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 5,255 | 10,336 | 11,810 | 22,726 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 3,652 | $ 12,790 | $ 9,488 | $ 31,694 |
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, 2022 | |
Shares (in thousands) | |
Outstanding at beginning of period (in shares) | 3,586 |
Granted (in shares) | 967 |
Exercised (in shares) | (2) |
Canceled or forfeited (in shares) | (1,482) |
Outstanding at end of period (in shares) | 3,069 |
Exercisable at end of period (in shares) | 1,296 |
Vested and expected to vest at end of period (in shares) | 3,069 |
Weighted- average exercise price per share | |
Outstanding at beginning of period (in dollars per share) | $ 39.23 |
Granted (in dollars per share) | 7.48 |
Exercised (in dollars per share) | 1.04 |
Canceled or forfeited (in dollars per share) | 41.11 |
Outstanding at end of period (in dollars per share) | 29.48 |
Exercisable at end of period (in dollars per share) | 51.24 |
Vested and expected to vest at end of period (in dollars per share) | $ 29.48 |
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, 2022 $ / shares shares | |
Shares (in thousands) | |
Unvested balance at beginning of period (in shares) | shares | 3,193 |
Granted (in shares) | shares | 1,451 |
Vested (in shares) | shares | (293) |
Forfeited (in shares) | shares | (1,076) |
Unvested balance at end of period (in shares) | shares | 3,275 |
Weighted- average grant date fair value | |
Unvested balance at beginning of period (in dollars per share) | $ / shares | $ 16.21 |
Granted (in dollars per share) | $ / shares | 7.51 |
Vested (in dollars per share) | $ / shares | 25.65 |
Forfeited (in dollars per share) | $ / shares | 12.67 |
Unvested balance at end of period (in dollars per share) | $ / shares | $ 12.70 |
Net loss per share (Detail)
Net loss per share (Detail) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
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) | 8,630 | 8,710 |
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) | 4,958 | 6,099 |
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) | 3,408 | 1,865 |
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) | 264 | 746 |
Restructuring - Narrative (Deta
Restructuring - Narrative (Details) - April 2022 Reduction $ in Millions | 1 Months Ended |
Apr. 30, 2022 USD ($) | |
Restructuring Cost and Reserve [Line Items] | |
Plans to reduce workforce, as a percent | 30% |
Anticipated cost savings associated with restructuring | $ 6.6 |
Restructuring - Accrued Liabili
Restructuring - Accrued Liabilities Activity (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Restructuring Reserve [Roll Forward] | ||||
Total expense | $ 6,639 | $ 0 | $ 6,639 | $ 0 |
April 2022 Reduction | ||||
Restructuring Reserve [Roll Forward] | ||||
Beginning balance | 0 | 0 | ||
Total expense | 6,639 | 6,639 | ||
Expenses paid from inception through current period | 3,989 | 3,989 | ||
Remaining accrual at June 30, 2022 | $ 2,650 | $ 2,650 |
Subsequent Events (Details)
Subsequent Events (Details) - Private Placement - USD ($) shares in Millions, $ in Millions | 1 Months Ended | 3 Months Ended | |
Jun. 30, 2022 | Aug. 04, 2022 | Jun. 30, 2022 | |
Subsequent Event [Line Items] | |||
Proceeds from stock offering | $ 8.3 | $ 8.3 | |
Shares of common stock sold (in shares) | 2.1 | 2.1 | |
Offering costs | $ 8 | $ 8 | |
Subsequent Event | |||
Subsequent Event [Line Items] | |||
Proceeds from stock offering | $ 24.7 | ||
Shares of common stock sold (in shares) | 5.5 |