Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 25, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | BLUE | |
Entity Registrant Name | bluebird bio, Inc. | |
Entity Central Index Key | 0001293971 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 55,269,239 | |
Entity File Number | 001-35966 | |
Entity Tax Identification Number | 133680878 | |
Entity Address, Address Line One | 60 Binney Street | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | Massachusetts | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 339 | |
Local Phone Number | 499-9300 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and cash equivalents | $ 280,995 | $ 402,579 |
Marketable securities | 972,885 | 982,725 |
Prepaid expenses | 25,427 | 19,762 |
Receivables and other current assets | 21,473 | 13,931 |
Total current assets | 1,300,780 | 1,418,997 |
Marketable securities | 287,922 | 506,123 |
Property, plant and equipment, net | 129,135 | 246,622 |
Intangible assets, net | 16,480 | 13,169 |
Goodwill | 13,128 | 13,128 |
Operating lease right-of-use assets | 190,979 | |
Restricted cash and other non-current assets | 84,920 | 44,805 |
Total assets | 2,023,344 | 2,242,844 |
Current Liabilities: | ||
Accounts payable | 29,458 | 17,831 |
Accrued expenses and other current liabilities | 91,105 | 99,393 |
Operating lease liability, current portion | 18,872 | |
Deferred revenue, current portion | 9,484 | 18,602 |
Collaboration research advancement, current portion | 13,190 | 10,605 |
Total current liabilities | 162,109 | 146,431 |
Deferred revenue, net of current portion | 13,739 | 16,338 |
Collaboration research advancement, net of current portion | 28,333 | 33,349 |
Contingent consideration | 5,740 | 5,230 |
Operating lease liability, net of current portion | 175,350 | |
Financing lease obligation, net of current portion | 153,319 | |
Other non-current liabilities | 1,699 | 3,107 |
Total liabilities | 386,970 | 357,774 |
Commitments and contingencies (Note 8) | ||
Stockholders’ Equity: | ||
Preferred stock, $0.01 par value, 5,000 shares authorized; 0 shares issued and outstanding at June 30, 2019 and December 31, 2018 | ||
Common stock, $0.01 par value, 125,000 shares authorized; 55,228 and 54,738 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 553 | 547 |
Additional paid-in capital | 3,489,112 | 3,386,958 |
Accumulated other comprehensive loss | (819) | (3,627) |
Accumulated deficit | (1,852,472) | (1,498,808) |
Total stockholders’ equity | 1,636,374 | 1,885,070 |
Total liabilities and stockholders’ equity | $ 2,023,344 | $ 2,242,844 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 55,228,000 | 54,738,000 |
Common stock, shares outstanding | 55,228,000 | 54,738,000 |
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, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenue: | ||||
Total revenues | $ 13,296 | $ 7,851 | $ 25,767 | $ 23,808 |
Operating expenses: | ||||
Research and development | 146,540 | 115,014 | 269,180 | 212,123 |
General and administrative | 68,631 | 41,168 | 128,910 | 76,094 |
Cost of license and royalty revenue | $ 613 | $ 21 | $ 1,043 | $ 36 |
Type of cost, good or service [Extensible List] | blue:LicenseAndRoyaltyMember | blue:LicenseAndRoyaltyMember | blue:LicenseAndRoyaltyMember | blue:LicenseAndRoyaltyMember |
Change in fair value of contingent consideration | $ 214 | $ 262 | $ 510 | $ 796 |
Total operating expenses | 215,998 | 156,465 | 399,643 | 289,049 |
Loss from operations | (202,702) | (148,614) | (373,876) | (265,241) |
Interest income, net | 9,387 | 2,436 | 19,489 | 3,824 |
Other (expense) income, net | (2,936) | 182 | (6,325) | 297 |
Loss before income taxes | (196,251) | (145,996) | (360,712) | (261,120) |
Income tax benefit | 469 | 484 | ||
Net loss | $ (195,782) | $ (145,996) | $ (360,228) | $ (261,120) |
Net loss per share - basic and diluted: | $ (3.55) | $ (2.91) | $ (6.54) | $ (5.22) |
Weighted-average number of common shares used in computing net loss per share - basic and diluted: | 55,165 | 50,153 | 55,062 | 50,038 |
Other comprehensive income (loss): | ||||
Other comprehensive income (loss), net of tax expense of $0.8 million and $0.0 million for the three months ended June 30, 2019 and 2018, respectively, and $1.3 million and $0.0 million for the six months ended June 30, 2019 and 2018, respectively | $ 973 | $ (345) | $ 2,808 | $ (1,189) |
Total other comprehensive income (loss) | 973 | (345) | 2,808 | (1,189) |
Comprehensive loss | (194,809) | (146,341) | (357,420) | (262,309) |
Collaboration [Member] | ||||
Revenue: | ||||
Total revenues | 11,558 | 7,437 | 22,735 | 23,045 |
License and Royalty [Member] | ||||
Revenue: | ||||
Total revenues | $ 1,738 | $ 414 | $ 3,032 | $ 763 |
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, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Income Statement [Abstract] | ||||
Other comprehensive income (loss) tax expense | $ 0.8 | $ 0 | $ 1.3 | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2017 | $ 1,623,432 | $ 494 | $ 2,540,951 | $ (4,205) | $ (913,808) |
Beginning balance, shares at Dec. 31, 2017 | 49,406 | ||||
Adjustment to beginning accumulated deficit from adoption of accounting standard update | ASU 2014-09 [Member] | (29,375) | (29,375) | |||
Vesting of restricted stock units | $ 1 | (1) | |||
Vesting of restricted stock units, shares | 74 | ||||
Issuance of common stock upon public offering, net of issuance costs | 48,701 | $ 3 | 48,698 | ||
Issuance of common stock upon public offering, net of issuance costs, shares | 277 | ||||
Exercise of stock options | 19,730 | $ 3 | 19,727 | ||
Exercise of stock options, shares | 301 | ||||
Purchase of common stock under ESPP | 687 | 687 | |||
Purchase of common stock under ESPP, shares | 9 | ||||
Stock-based compensation | 22,995 | 22,995 | |||
Other comprehensive income (loss) | (844) | (844) | |||
Net loss | (115,126) | (115,126) | |||
Ending balance at Mar. 31, 2018 | 1,570,201 | $ 501 | 2,633,057 | (5,049) | (1,058,308) |
Ending balance, shares at Mar. 31, 2018 | 50,067 | ||||
Beginning balance at Dec. 31, 2017 | 1,623,432 | $ 494 | 2,540,951 | (4,205) | (913,808) |
Beginning balance, shares at Dec. 31, 2017 | 49,406 | ||||
Other comprehensive income (loss) | (1,189) | ||||
Net loss | (261,120) | ||||
Ending balance at Jun. 30, 2018 | 1,457,534 | $ 502 | 2,666,729 | (5,394) | (1,204,303) |
Ending balance, shares at Jun. 30, 2018 | 50,225 | ||||
Beginning balance at Mar. 31, 2018 | 1,570,201 | $ 501 | 2,633,057 | (5,049) | (1,058,308) |
Beginning balance, shares at Mar. 31, 2018 | 50,067 | ||||
Vesting of restricted stock units, shares | 33 | ||||
Exercise of stock options | 5,617 | $ 1 | 5,616 | ||
Exercise of stock options, shares | 125 | ||||
Stock-based compensation | 28,056 | 28,056 | |||
Other comprehensive income (loss) | (345) | (345) | |||
Net loss | (145,996) | (145,996) | |||
Ending balance at Jun. 30, 2018 | 1,457,534 | $ 502 | 2,666,729 | (5,394) | (1,204,303) |
Ending balance, shares at Jun. 30, 2018 | 50,225 | ||||
Beginning balance at Dec. 31, 2018 | $ 1,885,070 | $ 547 | 3,386,958 | (3,627) | (1,498,808) |
Beginning balance, shares at Dec. 31, 2018 | 54,738 | 54,738 | |||
Adjustment to beginning accumulated deficit from adoption of accounting standard update | ASU 2016-02 [Member] | $ 6,564 | 6,564 | |||
Vesting of restricted stock units | $ 2 | (2) | |||
Vesting of restricted stock units, shares | 131 | ||||
Exercise of stock options | 9,504 | $ 2 | 9,502 | ||
Exercise of stock options, shares | 189 | ||||
Purchase of common stock under ESPP | 1,231 | 1,231 | |||
Purchase of common stock under ESPP, shares | 11 | ||||
Stock-based compensation | 32,341 | 32,341 | |||
Other comprehensive income (loss) | 1,835 | 1,835 | |||
Net loss | (164,446) | (164,446) | |||
Ending balance at Mar. 31, 2019 | 1,772,099 | $ 551 | 3,430,030 | (1,792) | (1,656,690) |
Ending balance, shares at Mar. 31, 2019 | 55,069 | ||||
Beginning balance at Dec. 31, 2018 | $ 1,885,070 | $ 547 | 3,386,958 | (3,627) | (1,498,808) |
Beginning balance, shares at Dec. 31, 2018 | 54,738 | 54,738 | |||
Exercise of stock options, shares | 282 | ||||
Other comprehensive income (loss) | $ 2,808 | ||||
Net loss | (360,228) | ||||
Ending balance at Jun. 30, 2019 | $ 1,636,374 | $ 553 | 3,489,112 | (819) | (1,852,472) |
Ending balance, shares at Jun. 30, 2019 | 55,228 | 55,228 | |||
Beginning balance at Mar. 31, 2019 | $ 1,772,099 | $ 551 | 3,430,030 | (1,792) | (1,656,690) |
Beginning balance, shares at Mar. 31, 2019 | 55,069 | ||||
Vesting of restricted stock units | $ 1 | (1) | |||
Vesting of restricted stock units, shares | 66 | ||||
Exercise of stock options | 3,973 | $ 1 | 3,972 | ||
Exercise of stock options, shares | 93 | ||||
Stock-based compensation | 55,111 | 55,111 | |||
Other comprehensive income (loss) | 973 | 973 | |||
Net loss | (195,782) | (195,782) | |||
Ending balance at Jun. 30, 2019 | $ 1,636,374 | $ 553 | $ 3,489,112 | $ (819) | $ (1,852,472) |
Ending balance, shares at Jun. 30, 2019 | 55,228 | 55,228 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Statement Of Stockholders Equity [Abstract] | |
Costs from IPO | $ 2,563 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Cash flows from operating activities: | ||||
Net loss | $ (360,228) | $ (261,120) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Change in fair value of contingent consideration | 510 | 796 | ||
Depreciation and amortization | 7,831 | 8,199 | ||
Stock-based compensation expense | 87,452 | 51,051 | ||
Unrealized loss on equity securities | 6,184 | |||
Other non-cash items | (7,064) | 2,834 | ||
Changes in operating assets and liabilities: | ||||
Prepaid expenses and other assets | (20,694) | (3,279) | ||
Operating lease right-of-use assets | 11,037 | |||
Accounts payable | 6,652 | 4,097 | ||
Accrued expenses and other liabilities | (9,301) | 9,789 | ||
Operating lease liabilities | (259) | |||
Deferred revenue | (11,716) | (21,589) | ||
Collaboration research advancement | (2,431) | |||
Net cash used in operating activities | (292,027) | (209,222) | ||
Cash flows from investing activities: | ||||
Purchase of property, plant and equipment | (37,925) | (20,689) | ||
Purchases of marketable securities | (471,365) | (689,163) | ||
Proceeds from maturities of marketable securities | 704,803 | 417,640 | ||
Net cash provided by (used in) investing activities | 195,513 | (292,212) | ||
Cash flows from financing activities: | ||||
Proceeds from public offering of common stock, net of issuance costs | 48,702 | |||
Reimbursement of assets under financing lease obligation | 3,098 | |||
Payments on financing lease obligation | (446) | |||
Proceeds from exercise of stock options and ESPP contributions | 15,004 | 25,624 | ||
Net cash provided by financing activities | 15,004 | 76,978 | ||
Decrease in cash, cash equivalents and restricted cash | (81,510) | (424,456) | ||
Cash, cash equivalents and restricted cash at beginning of period | 417,099 | 772,268 | ||
Cash, cash equivalents and restricted cash at end of period | 335,589 | 347,812 | ||
Reconciliation of cash, cash equivalents and restricted cash: | ||||
Cash and cash equivalents | $ 280,995 | $ 333,949 | ||
Restricted cash included in receivables and other current assets | $ 100 | $ 100 | ||
Restricted Cash, Current, Asset, Statement of Financial Position [Extensible List] | blue:ReceivablesAndOtherCurrentAssets | blue:ReceivablesAndOtherCurrentAssets | ||
Restricted cash included in restricted cash and other non-current assets | $ 54,494 | $ 13,763 | ||
Restricted Cash, Noncurrent, Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | us-gaap:OtherAssetsNoncurrent | ||
Total cash, cash equivalents and restricted cash | 417,099 | 772,268 | $ 335,589 | $ 347,812 |
Supplemental cash flow disclosures from investing and financing activities: | ||||
Purchases of property, plant and equipment included in accounts payable and accrued expenses | 8,869 | $ 7,815 | ||
Assets acquired under operating lease obligation | $ 17,489 |
Description of the business
Description of the business | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of the business | 1. Description of the business bluebird bio, Inc. (the “Company” or “bluebird”) was incorporated in Delaware on April 16, 1992, and is headquartered in Cambridge, Massachusetts. The Company is a biotechnology company committed to researching, developing and commercializing potentially transformative gene therapies for severe genetic diseases and cancer. Since its inception, the Company has devoted substantially all of its resources to its research and development efforts relating to its product candidates, including activities to manufacture product candidates, conduct clinical studies of its product candidates, perform preclinical research to identify new product candidates and provide general and administrative support for these operations. The Company’s programs in severe genetic diseases include ZYNTEGLO TM A-T87Q ® TM refer Collaborative arrangements . In June 2019, the Company received conditional marketing authorization from the European Commission for ZYNTEGLO (formerly referred to as LentiGlobin for TDT) for the treatment of patients 12 years and older with TDT who do not have a β 0 0 hrough June 30, 2019, the Company had not generated any revenue from product sales and had not capitalized any inventory costs related to the production of ZYNTEGLO. As of June 30, 2019, the Company had cash, cash equivalents and marketable securities of $1.54 billion. Although the Company has incurred recurring losses and expects to continue to incur losses for the foreseeable future, the Company expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund current planned operations for at least the next twelve months. |
Basis of presentation, principl
Basis of presentation, principles of consolidation and significant accounting policies | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of presentation, principles of consolidation and significant accounting policies | 2. Basis of presentation, principles of consolidation and significant accounting policies Basis of presentation The accompanying condensed consolidated financial statements are unaudited and have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These interim 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, 2019 and 2018. 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 interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2018, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 21, 2019. Certain items in the prior year’s condensed consolidated financial statements have been reclassified to conform to the current presentation. As a result, no subtotals in the prior year condensed consolidated financial statements were impacted. Amounts reported are computed based on thousands. As a result, certain totals may not sum due to rounding. The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to GAAP. The Company views its operations and manages its business in one operating segment. Significant accounting policies The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and six months ended June 30, 2019 are consistent with those discussed in Note 2 to the consolidated financial statements included in the Company’s 2018 Annual Report on Form 10-K, except as noted below with respect to the Company’s lease accounting policies and as noted within the “Recent accounting pronouncements – Recently adopted” Leases Effective January 1, 2019, the Company adopted ASU 2016-02, Leases (Topic 842), At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable. The Company does not have material financing leases. Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. To estimate its incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have a rating agency-based credit rating. Prospectively, the Company will adjust the right-of-use assets for straight-line rent expense or any incentives received and remeasure the lease liability at the net present value using the same incremental borrowing rate that was in effect as of the lease commencement or transition date. The Company has elected not to recognize leases with an original term of one year or less on the balance sheet. The Company typically only includes an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. ASC 842 transition practical expedients and application of transition provisions to leases at the transition date The Company elected the following practical expedients, which must be elected as a package and applied consistently to all of its leases at the transition date (including those for which the entity is a lessee or a lessor): i) the Company did not reassess whether any expired or existing contracts are or contain leases; ii) the Company did not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with ASC 840 are classified as operating leases, and all existing leases that were classified as capital leases in accordance with ASC 840 are classified as finance leases); and iii) the Company did not reassess initial direct costs for any existing leases. For leases that existed prior to the date of initial application of ASC 842 (which were previously classified as operating leases), a lessee may elect to use either the total lease term measured at lease inception under ASC 840 or the remaining lease term as of the date of initial application of ASC 842 in determining the period for which to measure its incremental borrowing rate. In transition to ASC 842, the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates. Application of ASC 842 policy elections to leases post adoption The Company has made certain policy elections to apply to its leases executed post adoption, or subsequent to January 1, 2019, as further described below. In accordance with ASC 842, components of a lease should be split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. Entities may elect not to separate lease and non-lease components. Rather, entities would account for each lease component and related non-lease component together as a single lease component. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only. ASC 842 allows for the use of judgment in determining whether the assumed lease term is for a major part of the remaining economic life of the underlying asset and whether the present value of lease payments represents substantially all of the fair value of the underlying asset. The Company applies the bright line thresholds referenced in ASC 842-10-55-2 to assist in evaluating leases for appropriate classification. The aforementioned bright lines are applied consistently to the Company’s entire portfolio of leases. 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 Recent accounting pronouncements Recently adopted ASU No. 2016-02, Leases (Topic 842), ASU No. 2018-10 Codification Improvements to Topic 842, Leases, ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, and ASU No. 2019-01 Leases (Topic 842): Codification Improvements In February 2016, the FASB issued ASU 2016-02, as amended, which superseded the lease accounting requirements in ASC 840 and created ASC 842. ASC 842 requires a lessee to recognize assets and liabilities on the balance sheet for most leases and changes many key definitions, including the definition of a lease. The new standard includes a short-term lease exception for leases with a term of one year or less, as part of which a lessee can make an accounting policy election not to recognize lease assets and lease liabilities for those leases. Lessees will continue to differentiate between finance leases (previously referred to as capital leases) and operating leases using classification criteria that are substantially similar to the previous guidance. Effective January 1, 2019, the Company adopted ASU 2016-02, using the required modified retrospective approach and utilizing the effective date as its date of initial application. As a result, prior periods are presented in accordance with the previous guidance in ASC 840. The adoption of this standard resulted in the recognition of operating lease right-of-use assets and operating lease liabilities of $184.4 million and $177.0 million, respectively, on the Company’s condensed consolidated balance sheet at adoption relating to its leases for its corporate headquarters at 60 Binney Street in Cambridge, Massachusetts (the “60 Binney Street Lease”), its office and laboratory space in Seattle, Washington, its office space in Zug, Switzerland, and its embedded leases associated with certain of the Company’s contract manufacturing agreements. The application of the standard’s transition guidance required the de-recognition of the 60 Binney Street Lease building asset, financing lease obligation, current portion, and financing lease obligation, net of current portion in the amounts of $149.3 million, $1.4 million, and $153.3 million, respectively, as well as certain other adjustments to related account balances. In adopting ASU 2016-02, the Company recorded a total one-time adjustment of $6.6 million to the opening balance of accumulated deficit as of January 1, 2019 primarily relating to the de-recognition of the 60 Binney Street Lease building asset and related finance lease obligation. As a result of adopting ASU 2016-02, the Company recorded an increase to deferred tax assets and deferred tax liabilities of $5.3 million and $7.1 million, respectively. The $1.8 million net increase to deferred tax liabilities and an offsetting valuation allowance adjustment was recorded through the accumulated deficit as of January 1, 2019, such that there was no tax impact on the Company’s condensed consolidated financial statements as a result of adoption. ASU No. 2017-08, Receivables – Nonrefundable Fees and Other Costs (Topic 310-20): Premium Amortization on Purchased Callable Debt Securities In April 2017, the FASB issued ASU 2017-08, Receivables – Nonrefundable Fees and Other Costs (Topic 310-20): Premium Amortization on Purchased Callable Debt Securities (“Subtopic 310-20”) Subtopic 310-20 calls for a modified retrospective application under which . The Company adopted this standard on January 1, 2019 and it did not financial position or results of operations upon adoption. ASU No. 2018-02, Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income In February 2018, the FASB issued ASU 2018-02, Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income The Company adopted this standard on January 1, 2019 and it did not have a material impact on the Company’s financial position and results of operations Not yet adopted ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 362): Measurement of Credit Losses on Financial Statements, ASU No. 2019-05 Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 362): Measurement of Credit Losses on Financial Statements ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment In January 2017, the FASB issued ASU 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, (“ASU 2018-13”). ASU No. 2018-15, Intangibles-Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract, (“ASU 2018-15”) ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”) ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments In April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, (“ASU 2019-04”). financial position or results of operations upon adoption. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Marketable securities | 3. Marketable securities The following table summarizes the marketable securities held at June 30, 2019 and December 31, 2018 (in thousands): Description Amortized cost / Cost Unrealized gains Unrealized losses Fair value June 30, 2019 U.S. government agency securities and treasuries $ 1,060,606 $ 3,084 $ (519 ) $ 1,063,171 Certificates of deposit 4,520 — — 4,520 Corporate bonds 113,820 633 (12 ) 114,441 Commercial paper 62,692 — — 62,692 Equity securities 20,017 — (4,034 ) 15,983 Total $ 1,261,655 $ 3,717 $ (4,565 ) $ 1,260,807 December 31, 2018 U.S. government agency securities and treasuries $ 1,459,649 $ 963 $ (3,011 ) $ 1,457,601 Certificates of deposit 9,080 — — 9,080 Equity securities 20,017 2,150 — 22,167 Total $ 1,488,746 $ 3,113 $ (3,011 ) $ 1,488,848 No available-for-sale debt securities held as of June 30, 2019 or December 31, 2018 had remaining maturities greater than three years. |
Fair value measurements
Fair value measurements | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | 4. 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, 2019 and December 31, 2018 (in thousands): Description Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) June 30, 2019 Assets: Cash and cash equivalents $ 280,995 $ 280,995 $ — $ — Marketable securities: U.S. government agency securities and treasuries 1,063,171 — 1,063,171 — Certificates of deposit 4,520 — 4,520 — Commercial paper 62,692 — 62,692 — Corporate bonds 114,441 — 114,441 — Equity securities 15,983 15,983 — — Total assets $ 1,541,802 $ 296,978 $ 1,244,824 $ — Liabilities: Contingent consideration $ 5,740 $ — $ — $ 5,740 Total liabilities $ 5,740 $ — $ — $ 5,740 December 31, 2018 Assets: Cash and cash equivalents $ 402,579 $ 348,638 $ 53,941 $ — Marketable securities: U.S. government agency securities and treasuries 1,457,601 — 1,457,601 — Certificates of deposit 9,080 — 9,080 — Equity securities 22,167 22,167 — — Total assets $ 1,891,427 $ 370,805 $ 1,520,622 $ — Liabilities: Contingent consideration $ 5,230 $ — $ — $ 5,230 Total liabilities $ 5,230 $ — $ — $ 5,230 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, 2019, cash and cash equivalents comprise funds in cash and money market accounts. As of December 31, 2018, cash and cash equivalents comprise funds in cash, U.S. treasury securities, U.S. government agency securities, and money market accounts. Marketable securities Marketable securities classified as Level 2 within the valuation hierarchy generally consist of certificates of deposit, U.S. treasury securities and government agency securities, corporate bonds, and commercial paper. The Company estimates the fair values of these marketable securities by taking into consideration valuations obtained from third-party pricing sources. These pricing sources utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include market pricing based on real-time trade data for the same or similar securities, issuer credit spreads, benchmark yields, and other observable inputs. The Company validates the prices provided by its third-party pricing sources by understanding the models used, obtaining market values from other pricing sources and analyzing pricing data in certain instances. The amortized cost of available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to the earliest call date for premiums or to maturity for discounts. At June 30, 2019 and December 31, 2018, 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 The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of June 30, 2019 and December 31, 2018 was $52.4 million and $787.5 million, respectively. As of June 30, 2019 and December 31, 2018, there were $229.2 million and $315.3 million in securities held by the Company in an unrealized loss position for more than twelve months, respectively. The aggregate unrealized loss on securities held by the Company for less than twelve months as of June 30, 2019 and December 31, 2018 was $0.1 million and $0.9 million, respectively. The aggregate unrealized loss on securities held by the Company for more than twelve months as of June 30, 2019 and December 31, 2018 was $0.5 million and $2.1 million, respectively. The Company has the intent and ability to hold such securities until recovery. The Company determined that there was no material change in the credit risk of the above investments. As a result, the Company determined it did not hold any investments with any other-than-temporary impairment as of June 30, 2019 and December 31, 2018. The Company holds equity securities with an aggregate fair value of $16.0 million and $22.2 million as of June 30, 2019 and December 31, 2018, respectively, within short-term marketable securities on its condensed consolidated balance sheet. The Company has recorded a $3.1 million and $6.2 million unrealized loss during the three and six months ended June 30, 2019, respectively, related to its equity securities, which is included in other (expense) income, net on the condensed consolidated statements of operations and comprehensive loss. Contingent consideration In connection with its prior acquisition of Precision Genome Engineering, Inc. (“Pregenen”), the Company may be required to pay future consideration that is contingent upon the achievement of specified development, regulatory approvals or sales-based milestone events. Contingent consideration is measured at fair value and is based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The valuation of contingent consideration uses assumptions the Company believes would be made by a market participant. The Company assesses these estimates on an on-going basis as additional data impacting the assumptions is obtained. Future changes in the fair value of contingent consideration related to updated assumptions and estimates are recognized within the condensed consolidated statements of operations and comprehensive loss. In the absence of new information, changes in fair value will reflect changing discount rates and the passage of time. The significant unobservable inputs used in the measurement of fair value of the Company’s contingent consideration are probabilities of successful achievement of clinical and commercial milestones, the period in which these milestones are expected to be achieved ranging from The table below provides a roll-forward of fair value of the Company’s contingent consideration obligations, which include Level 3 inputs (in thousands): For the six months ended June 30, 2019 Beginning balance $ 5,230 Additions — Changes in fair value 510 Payments — Ending balance $ 5,740 Please refer to Note 8, “Commitments and contingencies” |
Property, plant and equipment,
Property, plant and equipment, net | 6 Months Ended |
Jun. 30, 2019 | |
Property Plant And Equipment [Abstract] | |
Property, plant and equipment, net | 5. Property, plant and equipment, net Property, plant and equipment, net, consists of the following (in thousands): As of As of June 30, 2019 December 31, 2018 Land $ 1,210 $ 1,210 Building 14,913 180,094 Computer equipment and software 6,518 6,365 Office equipment 6,308 5,584 Laboratory equipment 40,953 35,693 Leasehold improvements 21,598 183 Construction-in-progress 67,470 46,669 Total property, plant and equipment 158,970 275,798 Less accumulated depreciation and amortization (29,835 ) (29,176 ) Property, plant and equipment, net $ 129,135 $ 246,622 North Carolina manufacturing facility In November 2017, the Company acquired a manufacturing facility, which is in the process of construction, in Durham, North Carolina for the future manufacture of lentiviral vector for the Company’s gene therapies. Construction-in-progress as of June 30, 2019 and December 31, 2018 includes $63.7 million and $40.4 million, respectively, related to the North Carolina manufacturing facility. 60 Binney Street Lease As a result of the adoption of ASU 2016-02, the Company de-recognized $156.0 million of the building asset and $6.7 million of accumulated depreciation related to its corporate headquarters at 60 Binney Street. Prior to the adoption of ASU 2016-02, the Company classified leasehold improvements associated with the 60 Binney Street building as building assets. Subsequent to the adoption of ASU 2016-02, the leasehold improvements owned by the Company associated with the 60 Binney Street building are classified as leasehold improvements. Please refer to Note 2, “Basis of presentation, principles of consolidation and significant accounting policies” “Leases” |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 6 Months Ended |
Jun. 30, 2019 | |
Payables And Accruals [Abstract] | |
Accrued expenses and other current liabilities | 6. Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following (in thousands): As of As of June 30, 2019 December 31, 2018 Employee compensation $ 22,638 $ 28,567 Accrued manufacturing costs 20,497 21,618 Accrued clinical and contract research organization costs 16,035 11,891 Accrued property, plant, and equipment 6,113 5,451 Accrued license and milestone fees 1,690 7,739 Accrued professional fees 1,497 1,830 Financing lease obligation, current portion — 1,424 Other 22,635 20,873 Total accrued expenses and other current liabilities $ 91,105 $ 99,393 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Leases | 7. Leases The Company leases certain office and laboratory space. Additionally, the Company has embedded leases at contract manufacturing organizations. Embedded operating leases On June 3, 2016, the Company entered into a manufacturing agreement for the future commercial production of the Company’s ZYNTEGLO, LentiGlobin, and Lenti-D drug products with a contract manufacturing organization. Under this 12-year agreement, the contract manufacturing organization will complete the design, construction, validation and process validation of the leased suites prior to anticipated commercial launch of the product candidates. During construction, the Company paid $12.0 million upon the achievement of certain contractual milestones, and may pay up to $8.0 million in additional contractual milestones if the Company elects its option to lease additional suites. Construction was completed in March 2018 and beginning in April 2018 the Company pays $5.1 million per year in fixed suite fees as well as certain fixed labor, raw materials, testing and shipping costs for manufacturing services, and may pay additional suite fees if it elects its option to reserve or lease additional suites. The Company may terminate this agreement at any time upon payment of a one-time termination fee and up to 24 months of fixed suite and labor fees. The Company concluded in prior periods that this agreement contained an embedded lease under ASC 840 as the suites are designated for the Company’s exclusive use during the term of the agreement. The Company concluded that it was not the deemed owner during construction nor was it a capital lease under ASC 840. As a result, in prior periods the Company accounted for the agreement as an operating lease under ASC 840 and recognized straight-line rent expense over the non-cancellable term of the embedded lease. As part of its adoption of ASC 842, effective January 1, 2019, the Company carried forward its existing lease classification under ASC 840. Additionally, the Company recorded a right-of-use asset and lease liability for this operating lease on the effective date and is recognizing rent expense on a straight-line basis throughout the remaining term of the embedded lease. The Company’s other embedded leases are not material to the condensed consolidated financial statements. 60 Binney Street Lease On September 21, 2015, the Company entered into a lease agreement for office and laboratory space located in a building (the “Building”) at 60 Binney Street, Cambridge, Massachusetts (the “60 Binney Street Lease”), which is now the Company’s corporate headquarters. Under the terms of the 60 Binney Street Lease, starting on October 1, 2016, the Company leases approximately 253,108 square feet of office and laboratory space at $72.50 per square foot per year, or $18.4 million per year in base rent, which is subject to scheduled annual rent increases of 1.75% plus certain operating expenses and taxes. The Company currently maintains a $13.8 million collateralized letter of credit and, subject to the terms of the lease and certain reduction requirements specified therein, including market capitalization requirements, this amount may decrease to $9.2 million over time. Pursuant to a work letter entered into in connection with the 60 Binney Street Lease, the landlord contributed an aggregate of $42.4 million toward the cost of construction and tenant improvements for the Building. The Company occupied the Building beginning on March 27, 2017 and the 60 Binney Street Lease will continue until March 31, 2027. The Company has the option to extend the 60 Binney Street Lease for two successive five-year terms. The Company is accounting for this lease under ASC 842 using its initial 10-year term through March 31, 2027 and will reassess the lease term on a quarterly basis. Due to the Company’s involvement in the construction project, including having responsibility to pay for a portion of the costs of finish work and mechanical, electrical, and plumbing elements of the Building, among other items, the Company was deemed for accounting purposes to be the owner of the Building during the construction period, per ASC 840. Accordingly, under ASC 840, construction costs that were incurred by the landlord directly or indirectly through reimbursement to the Company as part of its tenant improvement allowance were recorded as an asset in Property, plant and equipment, net on the Company’s consolidated balance sheets. The Company evaluated the 60 Binney Street Lease upon occupancy on March 27, 2017 and determined that the 60 Binney Street Lease did not meet the criteria for “sale-leaseback” treatment under ASC 840. This determination was based on, among other things, the Company's continuing involvement with the property in the form of non-recourse financing to the lessor. Accordingly, upon occupancy, the Company commenced depreciating the portion of the building in service over a useful life of 40 years and incurred interest expense related to the financing obligation. As part of its adoption of ASC 842, the Company de-recognized the building asset and corresponding financing obligation recorded on the Company’s consolidated balance sheets as of December 31, 2018, in accordance with the ASC 842 transition guidance. In applying the ASC 842 transition guidance, the Company classified this lease as an operating lease and recorded a right-of-use asset of $127.3 million and lease liability of $125.8 million on the effective date. The Company is recognizing rent expense on a straight-line basis throughout the remaining term of the lease. 50 Binney Street Sublease In April 2019, the Company entered into a sublease agreement for office space located at 50 Binney Street in Cambridge, Massachusetts (the “50 Binney Street Sublease”) to supplement the Company’s corporate headquarters located at 60 Binney Street in Cambridge, Massachusetts. Under the terms of the 50 Binney Street Sublease, the Company will lease 267,278 square feet of office space for $99.95 per square foot, or $26.7 million per year in base rent subject to certain operating expenses, taxes and annual rent increases of approximately 3%. The lease will commence when the space is available for use by the Company, which is anticipated to be July 1, 2021, and end on December 31, 2030, unless the Company earlier occupies the premises or other conditions specified in the 50 Binney Street Sublease occur. The sublessor has the right to postpone the commencement date until January 1, 2022 by providing not less than nine months’ prior written notice to the Company. Upon signing the 50 Binney Street Sublease, the Company executed a $40.1 million cash-collateralized letter of credit, which may be reduced in the future subject to the terms of the 50 Binney Street Sublease and certain reduction requirements specified therein. The $40.1 million of cash collateralizing the letter of credit is classified as Restricted cash and other non-current assets on the Company’s condensed consolidated balance sheets. Payments will commence at the earlier of (i) the date which is 90 days following the commencement date and (ii) the date the Company takes occupancy of all or any portion of the premises. In connection with the execution of the 50 Binney Street Sublease, the Company also entered into a Purchase Agreement 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, all of which was recorded within Restricted cash and other non-current assets on the Company’s condensed consolidated balance sheets as of June 30, 2019. The Company will assess the lease classification of the 50 Binney Street Sublease and commence recognition of the associated rent expense upon lease commencement. Summary of all lease costs recognized under ASC 842 The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases for the three and six months ended June 30, 2019: Operating leases For the three months ended For the six months ended (in thousands) June 30, 2019 June 30, 2019 Lease cost (1) Operating lease cost $ 8,917 $ 17,400 Total lease cost $ 8,917 $ 17,400 Other information Operating cash flows used for operating leases $ 13,237 Weighted average remaining lease term 7.7 years Weighted average discount rate 6.17 % (1) Short-term lease costs and variable lease costs incurred by the Company for the three and six months ended June 30, 2019 were immaterial. As of June 30, 2019, future minimum commitments under ASC 842 under the Company’s operating leases were as follows: Maturity of lease liabilities As of (in thousands) June 30, 2019 2019 (excluding the six months ended June 30, 2019) $ 17,031 2020 33,780 2021 34,215 2022 29,417 2023 29,869 2024 and thereafter 108,687 Total lease payments 252,999 Less: imputed interest (58,777 ) Total operating lease liabilities $ 194,222 The above table excludes legally binding minimum lease payments for leases executed but not yet commenced as of June 30, 2019. |
Commitments and contingencies
Commitments and contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and contingencies | 8. Commitments and contingencies Contingent consideration related to business combinations On June 30, 2014, the Company acquired Pregenen. The Company may be required to make up to $120.0 million in remaining future contingent cash payments to the former equityholders of Pregenen upon the achievement of certain clinical and commercial milestones related to the Pregenen technology, of which $20.1 million relates to clinical milestones and $99.9 million relates to commercial milestones. In accordance with accounting guidance for business combinations, contingent consideration liabilities are required to be recognized on the consolidated balance sheets at fair value. Estimating the fair value of contingent consideration requires the use of significant assumptions primarily relating to probabilities of successful achievement of certain clinical and commercial milestones, the expected timing in which these milestones will be achieved and discount rates. The use of different assumptions could result in materially different estimates of fair value. Please refer to Note 4, “Fair value measurements” Other funding commitments The Company is party to various agreements, principally relating to licensed technology, that require future payments relating to milestones that may be met in subsequent periods or royalties on future sales of specified products, which includes the collaboration agreement entered into with Regeneron Pharmaceuticals, Inc. (“Regeneron”) in August 2018. 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 “Collaborative arrangements,” The Company may be obligated to make future development, regulatory and commercial milestone payments and royalty payments on future sales of specified products associated with its collaboration and license agreements. Payments under these agreements generally become due and payable upon achievement of such milestones or sales. When the achievement of these milestones or sales have occurred, the corresponding amounts are recognized in the Company’s financial statements. 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 indemnified |
Collaborative Arrangements
Collaborative Arrangements | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborative Arrangements | 9. Collaborative arrangements To date, the Company’s collaboration revenue has been exclusively generated from its collaboration arrangements with Celgene Corporation and Regeneron, each as further described below. Celgene Celgene Original Collaboration Agreement On March 19, 2013, the Company entered into a Master Collaboration Agreement (the “Celgene Collaboration Agreement”) with Celgene to discover, develop and commercialize potentially disease-altering gene therapies in oncology. The collaboration is focused on applying gene therapy technology to genetically modify a patient’s own T cells, known as chimeric antigen receptor, or CAR T cells, to target and destroy cancer cells. Additionally, on March 19, 2013, the Company entered into a Platform Technology Sublicense Agreement (the “Sublicense Agreement”) with Celgene pursuant to which the Company obtained a sublicense to certain intellectual property from Celgene, originating under Celgene’s license from Baylor College of Medicine, for use in the collaboration. Under the terms of the Celgene Collaboration Agreement, the Company received a $75.0 million up-front, non-refundable cash payment. The Company was responsible for conducting discovery, research and development activities through completion of phase 1 clinical studies, if any, during the initial term of the Celgene Collaboration Agreement, or three years. The collaboration is governed by a joint steering committee (“JSC”) formed by an equal number of representatives from the Company and Celgene. The JSC, among other activities, reviews the collaboration program, reviews and evaluates product candidates and approves regulatory plans. In addition to the JSC, the Celgene Collaboration Agreement provides that the Company and Celgene each appoint representatives to a patent committee, which is responsible for managing the intellectual property developed and used during the collaboration. Celgene Amended Collaboration Agreement On June 3, 2015, the Company and Celgene amended and restated the Celgene Collaboration Agreement (the “Amended Celgene Collaboration Agreement”). Under the Amended Celgene Collaboration Agreement, the parties narrowed the focus of the collaboration to exclusively work on anti- B-cell maturation antigen (“BCMA”) product candidates for a new three-year term that ended in June 2018. In connection with the Amended Celgene Collaboration Agreement, the Company received an up-front, one-time, non-refundable, non-creditable payment of $25.0 million to fund research and development under the collaboration. The collaboration is governed by the JSC. Under the terms of the Amended Celgene Collaboration Agreement, for up to two product candidates selected for development under the collaboration, the Company was responsible for conducting and funding all research and development activities performed up through completion of the initial phase 1 clinical study of such product candidates. On a product candidate-by-product candidate basis, up through a specified period following enrollment of the first patient in an initial phase 1 clinical study for such product candidate (the “Option Period”), the Company had granted Celgene an option to obtain an exclusive worldwide license to develop and commercialize such product. Following Celgene’s license of each product candidate, the Company is entitled to elect to co-develop and co-promote each product candidate in the U.S. Celgene Ide-cel On February 10, 2016, Celgene exercised its option to obtain an exclusive worldwide license to develop and commercialize ide-cel, the first product candidate under the Amended Celgene Collaboration Agreement, pursuant to an executed license agreement (“Ide-cel License Agreement”) entered into by the parties on February 16, 2016 and paid to the Company the associated $10.0 million option fee. Pursuant to the Ide-cel License Agreement, Celgene was responsible for development and related funding of ide-cel after the substantial completion of the phase 1 clinical trial. The Company was responsible for the manufacture of vector and associated payload throughout development and upon Celgene’s request, throughout commercialization, the costs of which were reimbursable by Celgene in accordance with the terms of the Amended and Restated Co-Development, Co-Promote and Profit Share Agreement, as further described below. Celgene was responsible for the manufacture of drug product throughout development and commercialization. Celgene Ide-cel Co-Development, Co-Promote and Profit Share Agreement On March 28, 2018, the Company elected to co-develop and co-promote ide-cel within the U.S. pursuant to the execution of the Amended and Restated Co-Development, Co-Promote and Profit Share Agreement (“Ide-cel CCPS”), which replaced the Ide-cel License Agreement. The responsibilities of the parties remain unchanged from those under the Ide-cel License Agreement, however, the Company will share equally in all profits and losses relating to developing, commercializing and manufacturing ide-cel within the U.S. and has the right to participate in the development and promotion of ide-cel in the U.S. Celgene is responsible for the costs incurred to manufacture vector and associated payload for use outside of the U.S., plus a markup. Under the Ide-cel CCPS, the Company may receive up to a total of $70.0 million in development milestone payments for the first indication to be addressed by ide-cel, with the ability to obtain additional milestone payments for a second indication and modified licensed products. In the second quarter of 2019, a $10.0 million development milestone was achieved such that as of June 30, 2019, the total remaining potential development milestones on the first indication of ide-cel is $60.0 million. In addition, to the extent ide-cel is commercialized, the Company is entitled to receive tiered royalty payments ranging from the mid-single digits to low-teens based on a percentage of net sales generated outside of the U.S., subject to certain reductions. Celgene bb21217 License Agreement On September 22, 2017, Celgene exercised its option to obtain an exclusive worldwide license to develop and commercialize bb21217, the second product candidate under the Amended Celgene Collaboration Agreement, pursuant to an executed license agreement (“bb21217 License Agreement”) entered into by the parties on September 28, 2017 and paid the Company an option fee of $15.0 million. Pursuant to the bb21217 License Agreement, Celgene is responsible for development and related funding of bb21217 after the substantial completion of the on-going phase 1 clinical trial. The Company is responsible for the manufacture of vector and associated payload throughout development and upon Celgene’s request, throughout commercialization. Expenses incurred by the Company associated with these activities are fully reimbursable by Celgene at cost plus a mark-up. Throughout both development and commercialization, Celgene is responsible for the manufacture of drug product. The Company currently expects it will exercise its option to co-develop and co-promote bb21217 within the U.S. The Company’s election to co-develop and co-promote bb21217 must be made by the substantial completion of the on-going phase 1 clinical trial of bb21217. If elected, the Company expects the responsibilities of the parties to remain largely unchanged, however, the Company expects it will share equally in all profits and losses relating to developing, commercializing and manufacturing bb21217 within the U.S. and to have the right to participate in the development and promotion of bb21217 in the U.S. Celgene would be responsible for the costs incurred to manufacture vector and associated payload for use outside of the U.S., plus a markup. In the event the Company does not exercise its option to co-develop and co-promote bb21217, the Company will receive an additional fee in the amount of $10.0 million. Under this scenario, the Company may be eligible to receive up to $10.0 million in clinical milestone payments, up to $117.0 million in regulatory milestone payments, and up to $78.0 million in commercial milestone payments. In addition, to the extent bb21217 is commercialized, the Company would be entitled to receive tiered royalty payments ranging from the mid-single digits to low-teens based on a percentage of net sales, subject to certain reductions. Accounting Analysis – Ide-cel ASC Topic 606, Revenue From Contracts With Customers (“Topic 606”) As of the February 2016 contract modification date, the Company concluded the arrangement contained the following promised goods and services: (i) research and development services, (ii) a license to ide-cel, and (iii) manufacture of vectors and associated payload for incorporation into ide-cel through development. The Company determined that the manufacture of commercial vector represented an option to acquire additional goods and services that is not representative of a material right. In addition, as of the February 2016 contract modification date, Celgene had not exercised its option to purchase any commercial vector. Accordingly, the manufacture of commercial vector was not considered to be a performance obligation at that time. The Company concluded that the research and development services are distinct from the other promised goods and services under the arrangement given that Celgene can benefit from the research and development services on their own and such services are distinct within the context of the contract. Thus, such services are considered to be a separate performance obligation. The Company concluded that the license to ide-cel is not distinct from the vector manufacturing services because the manufacturing is essential to the use of the license. Accordingly, these two promised goods and services are considered a single combined performance obligation. Ide-cel transaction price The following tables summarize the total transaction price, the allocation of the total transaction price to the identified performance obligations under the arrangement, and the amount of the transaction price unsatisfied as of June 30, 2019: (in thousands) Ide-cel transaction price as of June 30, 2019 Up-front non-refundable payment - Celgene Collaboration Agreement $ 75,000 Up-front non-refundable payment - Amended Celgene Collaboration Agreement 25,000 Ide-cel license fee - Ide-cel License Agreement 10,000 Ide-cel development milestone 10,000 Estimated variable consideration 87,189 $ 207,189 (in thousands) Allocation of transaction price to performance obligations Transaction price unsatisfied as of June 30, 2019 Ide-cel research and development services $ 40,912 $ — Ide-cel license and manufacturing services 166,277 26,723 $ 207,189 $ 26,723 The estimated variable consideration of $87.2 million relates to the estimated reimbursement from Celgene for the manufacture of vectors and associated payload through development. The total transaction price has been allocated to the performance obligations identified based on a relative standalone selling price (“SSP”) basis. The Company estimated the SSP of the license after considering potential future cash flows under the license. The Company then discounted these probability-weighted cash flows to their present value. The Company estimated the SSP of each of the research and development services and manufacturing services to be provided based on the Company’s estimated cost of providing the services plus an applicable profit margin commensurate with observable market data for similar services. All of the clinical and regulatory milestones which have not been met as of period end are fully constrained and are excluded from the transaction price. As part of its evaluation of the constraint, the Company considered numerous factors, including the fact that achievement of the milestones is outside the control of the Company and contingent upon the future success of clinical trials, the licensee’s efforts, or the receipt of regulatory approval. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license granted to Celgene and therefore are recognized at the later of when the performance obligation is satisfied, or the related sales occur. The Company re-evaluates the transaction price, including its estimated variable consideration included in the transaction price and all constrained amounts, at each reporting period and as uncertain events are resolved or other changes in circumstances occur. Ide-cel research and development services The Company allocated $40.9 million of the transaction price to the research and development services. The Company satisfied this performance obligation as the research and development services were performed. The Company determined that the period of performance of the research and development services was three years through projected initial phase 1 clinical study substantial completion, or through May 2018. The Company recognized revenue related to research and development services performed using an input method by calculating costs incurred at each period end relative to total costs expected to be incurred. Although the Company fully satisfied this performance obligation during the second quarter of 2018, any changes to the total transaction price following the completion of this performance obligation in May 2018 will be allocated to the performance obligations under the arrangement based on a relative SSP basis and therefore the allocation of any changes to the total transaction price may impact the revenue recognized for this performance obligation in the period of change. The following table summarizes the revenue recognized, or revenue adjustment recorded, related to the ide-cel research and development services for the three and six months ended June 30, 2019 and 2018: For the three months ended June 30, For the six months ended June 30, (in thousands) 2019 2018 2019 2018 Ide-cel research and development services revenue $ 2,473 $ 953 $ 2,264 $ 3,136 $ 2,473 $ 953 $ 2,264 $ 3,136 Ide-cel license and manufacturing services The Company allocated $166.3 million of the transaction price to the combined unit of accounting which consists of the license and manufacture of vectors and associated payload for incorporation into ide-cel. The Company accounts for its vector manufacturing services for development in the U.S. and Celgene’s U.S. development efforts within the scope of ASC 808 given that both parties are active participants in the activities and both parties are exposed to significant risks and rewards dependent on the commercial success of the activities. The Company recognizes collaboration revenue for its U.S. manufacturing services by analogy to Topic 606. The portion of Celgene’s U.S. development costs that the Company is responsible for are recognized as a reduction to its collaboration revenues, or, if in excess of such revenues in a given quarter, the excess is recorded as research and development expense. Revenue recognition for the combined unit of accounting commenced during the first quarter of 2017. The Company recognizes revenue associated with the combined unit of accounting using the proportional performance method, as the Company will satisfy this performance obligation as the manufacturing services are performed through development. In using this method, the Company estimated its development plan for ide-cel, including expected demand from Celgene, and the costs associated with the manufacture of vectors and associated payload for incorporation into ide-cel. On a quarterly basis, the Company determines the proportion of effort incurred as a percentage of total effort it expects to expend. This ratio is applied to the transaction price, which includes variable consideration, allocated to the combined performance obligation consisting of the ide-cel license and manufacturing services. Management has applied significant judgment in the process of developing its budget estimates and any changes to these estimates will be recognized in the period in which they change as a cumulative catch up. The following table summarizes the net collaboration revenue recognized or expense incurred for the joint ide-cel development efforts in the U.S. under ASC 808, including revenue or expense related to the combined performance obligation for the license and vector manufacturing of ide-cel for development in the U.S., for the three and six months ended June 30, 2019, and 2018: For the three months ended June 30, For the six months ended June 30, (in thousands) 2019 2018 2019 2018 ASC 808 ide-cel revenue - U.S. (1) $ — $ — $ — $ 3,761 ASC 808 ide-cel research and development expense - U.S. (1) $ (1,065 ) $ (3,349 ) $ (4,309 ) $ (3,349 ) (1) As noted above, the calculation of collaboration revenue or research and development expense to be recognized for joint ide-cel development efforts in the U.S. is performed on a quarterly basis. The calculation is independent of previous activity, which may result in fluctuations between revenue and expense recognition period over period, depending on the varying extent of effort performed by each party during the period. Revenue related to the combined unit of accounting for the non-US license and vector manufacturing services is accounted for in accordance with Topic 606. The following table summarizes the revenue recognized related to the combined unit of accounting for the ide-cel non-US license and vector manufacturing services for the three and six months ended June 30, 2019, and 2018: For the three months ended June 30, For the six months ended June 30, (in thousands) 2019 2018 2019 2018 ASC 606 ide-cel license and manufacturing revenue - outside of U.S. $ 7,899 $ 5,764 $ 16,963 $ 14,706 As of June 30, 2019, the aggregate amount of the transaction price allocated to the combined performance obligation, which consists of the ide-cel license and manufacturing services, that is unsatisfied, or partially unsatisfied, is $26.7 million, which the Company expects to recognize as revenue as manufacturing services are provided through the remaining development period which is estimated to be through 2020. As of June 30, 2019 and December 31, 2018, the Company had $12.7 million and $23.0 million, respectively, of deferred revenue associated with the combined performance obligation consisting of the ide-cel license and manufacturing services. Accounting Analysis – bb21217 On September 22, 2017, Celgene exercised its option to obtain an exclusive worldwide license to develop and commercialize bb21217, the second optioned product candidate, pursuant to the bb21217 License Agreement entered into by the parties on September 28, 2017. The bb21217 License Agreement is considered a separate contract for accounting purposes as the option to obtain an exclusive worldwide license to develop and commercialize bb21217, or any other product candidate, was not considered a material right to Celgene at the time the practical expedient was applied. The Company made this evaluation after considering the significant uncertainty at that time regarding whether any additional product candidates would be identified under the Amended Celgene Collaboration Agreement. In particular, the Company considered that bb21217 had not been formally nominated as a product candidate under the collaboration at that time, primarily due to a lack of pre-clinical data as well as uncertainty surrounding the ability to successfully complete various IND-enabling activities. At contract inception, the Company concluded that the arrangement contained the following promised goods and services: (i) research and development services, (ii) a license to the second product candidate, bb21217, and (iii) manufacture of vectors and associated payload for incorporation into bb21217 through development. The Company determined that the manufacture of commercial vector represents an option to acquire additional goods and services that is not representative of a material right. In addition, at this time Celgene has not exercised its option to purchase any commercial vector. Accordingly, the manufacture of commercial vector is not considered to be a performance obligation at this time. The Company concluded that the research and development services are distinct from the other promised goods and services under the arrangement given that Celgene can benefit from the research and development services on their own and such services are distinct within the context of the contract . bb21217 transaction price The following tables summarize the total transaction price, the allocation of the total transaction price to the identified performance obligations under the arrangement, and the amount of the transaction price unsatisfied as of June 30, 2019: (in thousands) bb21217 transaction price as of June 30, 2019 bb21217 license fee - bb21217 License Agreement $ 15,000 Estimated variable consideration 26,687 $ 41,687 (in thousands) Allocation of transaction price to performance obligations Transaction price unsatisfied as of June 30, 2019 bb21217 research and development services $ 5,444 $ 721 bb21217 license and manufacturing services 36,243 36,243 $ 41,687 $ 36,964 The estimated variable consideration of $26.7 million relates to reimbursement from Celgene for the manufacturing services during development. The total transaction price has been allocated to the performance obligations identified based on a relative SSP basis. The Company estimated the SSP of the license after considering potential future cash flows under the license. The Company then discounted these probability-weighted cash flows to their present value. The Company estimated the SSP of each of the research and development services and manufacturing services to be provided based on the Company’s estimated cost of providing the services plus an applicable profit margin commensurate with observable market data for similar services. All of the clinical and regulatory milestones are fully constrained and are excluded from the transaction price. As part of its evaluation of the constraint, the Company considered numerous factors, including the fact that achievement of the milestones is outside the control of the Company and contingent upon the future success of its clinical trials, the licensee’s efforts, or the receipt of regulatory approval. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license granted to Celgene and therefore are recognized at the later of when the performance obligation is satisfied, or the related sales occur. The Company re-evaluates the transaction price, including its estimated variable consideration included in the transaction price and all constrained amounts, each reporting period and as uncertain events are resolved or other changes in circumstances occur. bb21217 research and development services The Company allocated $5.4 million of the transaction price to the research and development services. The Company will satisfy this performance obligation as the research and development services are performed. The Company determined that the period of performance of the research and development services was two years through projected initial phase 1 clinical study substantial completion, or through September 2019. The Company recognizes revenue related to research and development services performed using an input method by calculating costs incurred at each period end relative to total costs expected to be incurred. The following table summarizes the revenue recognized related to the bb21217 research and development services for the three and six months ended June 30, 2019, and 2018: For the three months ended June 30, For the six months ended June 30, (in thousands) 2019 2018 2019 2018 bb21217 research and development services revenue $ 721 $ 721 $ 1,442 $ 1,442 $ 721 $ 721 $ 1,442 $ 1,442 As of June 30, 2019, and December 31, 2018, the aggregate amount of the transaction price allocated to the bb21217 research and development services performance obligation that are unsatisfied, or partially unsatisfied, and deferred is $0.7 million and $1.8 million, respectively, which the Company expects to recognize through September 2019 as research and development services are performed. bb21217 license and manufacturing services The Company will satisfy its performance obligation related to the manufacture of vectors and associated payload for incorporation into bb21217 through development as the bb21217 manufacturing services are performed. As of June 30, 2019, the manufacturing services for bb21217 had not yet commenced. Therefore, no amounts have been recognized for the combined performance obligation in the consolidate statement of operations for the three and six months ended June 30, 2019, and 2018. The aggregate amount of the transaction price allocated to the combined performance obligation, which consists of the bb21217 license and manufacturing services, is $36.2 million. The Company does not expect that recognition will begin in the next twelve months and has therefore classified deferred revenue associated with the combined performance obligation as deferred revenue, net of current portion on its consolidated balance sheet. The Company had $9.8 million of remaining deferred revenue as of June 30, 2019 and December 31, 2018 associated with the combined performance obligation consisting of the bb21217 license and manufacturing services. Contract assets and liabilities – ide-cel and bb21217 The Company receives payments from its collaborative partners based on billing schedules established in each contract. Up-front payments and fees are recorded as deferred revenue upon receipt or when due until such time as the Company satisfies its performance obligations under these arrangements. A contract asset is a conditional right to consideration in exchange for goods or services that the Company has transferred to a customer. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The following table presents changes in the balances of the Company’s Celgene receivables and contract liabilities during the six months ended June 30, 2019: (in thousands) Balance at beginning of period Additions Deductions Balance at end of period Receivables $ 6,528 $ 10,450 $ (6,528 ) $ 10,450 Contract liabilities: Payable included in accrued expenses $ — $ 3,781 $ — $ 3,781 Deferred revenue $ 34,939 $ 10,000 $ (21,716 ) $ 23,223 The increase in the receivables balance for the six months ended June 30, 2019 is primarily driven by amounts owed to the Company for a development milestone that was achieved in the second quarter of 2019, offset by amounts collected from Celgene in the period and amounts owed to Celgene under the Ide-cel CCPS. The decrease in deferred revenue during the six months ended June 30, 2019 is primarily driven by amounts recognized for the combined performance obligation consisting of the ide-cel license and manufacturing services. During the six months ended June 30, 2019, $21.7 million of the deferred revenue balance at the beginning of the period was released from deferred revenue, of which $10.0 million was recognized as collaboration revenue and $11.7 million was recorded as contra-research and development expense. Regeneron Regeneron Collaboration Agreement On August 3, 2018, the Company entered into a Collaboration Agreement (the “Regeneron Collaboration Agreement”) with Regeneron pursuant to which the parties will apply their respective technology platforms to the discovery, development, and commercialization of novel immune cell therapies for cancer. On August 24, 2018, following the completion of required regulatory reviews, the Regeneron Collaboration Agreement became effective. Under the terms of the agreement, the parties will leverage Regeneron’s proprietary platform technologies for the discovery and characterization of fully human antibodies, as well as T cell receptors directed against tumor-specific proteins and peptides and the Company will contribute its field-leading expertise in gene therapy. In accordance with the Regeneron Collaboration Agreement, the parties jointly selected six initial targets and intend to equally share the costs of research up to the point of submitting an IND application for a potential gene therapy product directed to a particular target. Additional targets may be selected during the five-year research collaboration term as agreed to by the parties. Regeneron will accrue a certain number of option rights exercisable against targets as the parties reach certain milestones under the terms of the agreement. Upon the acceptance of an IND for the first product candidate directed to a target, Regeneron will have the right to exercise an option for co-development/co-commercialization of product candidates directed to such target on a worldwide or applicable opt-in territory basis, with certain exceptions. Where Regeneron chooses to opt-in, the parties will share equally in the costs of development and commercialization, and will share equally in any profits or losses therefrom in applicable opt-in territories. Outside of the applicable opt-in territories, the target becomes a licensed target and Regeneron would be eligible to receive, with respect to any resulting product, milestone payments of up to $130.0 million per product and royalties on net sales outside of the applicable opt-in territories at a rate ranging from the mid-single digits to low-double digits. A target would also become a licensed target in the event Regeneron does not have an option to such target, or Regeneron does not exercise its option with respect to such target. Either party may terminate a given research program directed to a particular target for convenience, and the other party may elect to continue such research program at its expense, receiving applicable cross-licenses. The terminating party will receive licensed product royalties and milestone payments on the potential applicable gene therapy products. Where the Company terminates a given research program for convenience, and Regeneron elects to continue such research program, the parties will enter into a transitional services agreement. Under certain conditions, following its opt-in, Regeneron may terminate a given collaboration program and the Company may elect to continue the development and commercialization of the applicable potential gene therapy products as licensed products. Regeneron Share Purchase Agreement A Share Purchase Agreement (“SPA”) was entered into by the parties on August 3, 2018. On August 24, 2018, the closing date of the transaction, the Company issued Regeneron 0.4 million shares of the Company’s common stock, subject to certain restrictions, for $238.10 per share, or $100.0 million in the aggregate. The purchase price represents $63.0 million worth of common stock plus a $37.0 million premium, which represents a collaboration research advancement, or credit to be applied to Regeneron’s initial 50 percent funding obligation for collaboration research, after which the collaborators will continue to fund ongoing research equally. The collaboration research advancement only applies to pre-IND research activities and is not refundable or creditable against post-IND research activities for any programs where Regeneron exercises their opt-in rights. Accounting analysis – Regeneron At the commencement of the arrangement, two units of accounting were identified, which are the issuance of 0.4 million shares of the Company’s common stock and joint research activities during the five-year research collaboration term. The Company determined the total transaction price to be $100.0 million, which comprises $54.5 million attributed to the equity sold to Regeneron and $45.5 million attributed to the joint research activities. In determining the fair value of the common stock at closing, the Company considered the closing price of the common stock on the closing date of the transaction and included a lack of marketability discount because Regeneron received shares subject to certain restrictions. The Company analyzed the joint research activities to assess whether they fall within the scope of ASC 808, and will reassess this throughout the life of the arrangement based on changes in the roles and responsibilities of the parties. Based o |
Equity
Equity | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Equity | 10. Equity In January 2018, the Company sold 0.3 million shares of common stock pursuant to the partial exercise of an overallotment option granted to the underwriters in connection with the December 2017 underwritten public offering at a price of $185.00 per share for aggregate net proceeds of $48.7 million. In July 2018, the Company sold 3.9 million shares of common stock (inclusive of shares sold pursuant to an overallotment option granted to the underwriters in connection with the offering) through an underwritten public offering at a price of $162.50 per share for aggregate net proceeds of $600.6 million. |
Stock-based compensation
Stock-based compensation | 6 Months Ended |
Jun. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based compensation | 11. Stock-based compensation In January 2019 and 2018, the number of shares of common stock available for issuance under the 2013 Stock Option and Incentive Plan (“2013 Plan”) was increased by approximately 2.2 million and 2.0 million shares, respectively, as a result of the automatic increase provision of the 2013 Plan. As of June 30, 2019, the total number of shares of common stock available for issuance under the 2013 Plan was approximately 2.2 million. Stock-based compensation expense The Company recognized stock-based compensation expense totaling $55.1 million and $87.5 million for the three and six months ended June 30, 2019, respectively. The Company recognized stock-based compensation expense totaling $28.1 million and $51.1 million for the three and six months ended June 30, 2018, respectively. Stock-based compensation expense by award type included within the condensed consolidated statements of operations and comprehensive loss was as follows: For the For the three months ended June 30, six months ended June 30, (in thousands) 2019 2018 2019 2018 Stock options $ 24,800 $ 20,932 $ 47,983 $ 38,227 Restricted stock units 30,012 6,953 38,893 12,494 Employee stock purchase plan 299 171 576 330 $ 55,111 $ 28,056 $ 87,452 $ 51,051 Stock-based compensation expense by classification included within the condensed consolidated statements of operations and comprehensive loss was as follows: For the For the three months ended June 30, six months ended June 30, (in thousands) 2019 2018 2019 2018 Research and development $ 29,694 $ 14,196 $ 45,210 $ 25,820 General and administrative 25,417 13,860 42,242 25,231 $ 55,111 $ 28,056 $ 87,452 $ 51,051 In February 2018, the Company issued restricted stock units with service and performance conditions to employees, approximately 0.2 million of which are outstanding as of June 30, 2019. Vesting of these awards is contingent on the occurrence of a certain regulatory milestone event which was achieved in June 2019 and fulfillment of any remaining service condition. The Company began recognizing expense for these awards in the second quarter of 2019 when achievement of the regulatory milestone was deemed probable. The Company recognized $20.1 million of expense related to these awards in the second quarter of 2019 and will continue to recognize As of June 30, 2019, the Company had $372.4 million of unrecognized stock-based compensation expense related to unvested stock options, restricted stock units, performance-based restricted stock units, and the employee stock purchase plan, which is expected to be recognized over a weighted-average period of 2.8 years Stock option activity The following table summarizes the stock option activity under the Company’s equity award plans: Shares (in thousands) Weighted- average exercise price per share Outstanding at December 31, 2018 4,643 $ 108.56 Granted 1,266 $ 136.17 Exercised (282 ) $ 47.80 Canceled, forfeited, or expired (234 ) $ 129.85 Outstanding at June 30, 2019 5,393 $ 117.30 Exercisable at June 30, 2019 2,520 $ 88.94 Vested and expected to vest at June 30, 2019 5,393 $ 117.30 During the six months ended June 30, 2019, 0.3 million shares of common stock were exercised, resulting in total proceeds to the Company of $13.5 million. In accordance with the Company’s equity award plans, the shares were issued from a pool of shares reserved for issuance under the equity award plans. Restricted stock unit activity The following table summarizes the restricted stock unit activity under the Company’s equity award plans: Shares (in thousands) Weighted- average grant date fair value Unvested balance at December 31, 2018 931 $ 155.99 Granted 438 $ 136.32 Vested (197 ) $ 142.82 Forfeited (69 ) $ 153.94 Unvested balance at June 30, 2019 1,103 $ 150.67 Employee stock purchase plan On June 3, 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 2018, less than 0.1 million shares |
Income taxes
Income taxes | 6 Months Ended |
Jun. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income taxes | 12. 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 benefit recorded during the three and six months ended June 30, 2019 is due to the deferred tax benefit for which an offsetting tax expense is recognized in other comprehensive income (loss), partially reduced by state and foreign income taxes. |
Net loss per share
Net loss per share | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net loss per share | 13. 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: For the three and six months ended June 30, (in thousands) 2019 2018 Outstanding stock options 5,393 4,505 Restricted stock units 1,103 931 ESPP shares 15 5 6,511 5,441 |
Basis of presentation, princi_2
Basis of presentation, principles of consolidation and significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The accompanying condensed consolidated financial statements are unaudited and have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These interim 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, 2019 and 2018. 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 interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2018, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 21, 2019. Certain items in the prior year’s condensed consolidated financial statements have been reclassified to conform to the current presentation. As a result, no subtotals in the prior year condensed consolidated financial statements were impacted. Amounts reported are computed based on thousands. As a result, certain totals may not sum due to rounding. The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to GAAP. The Company views its operations and manages its business in one operating segment. |
Significant accounting policies | 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, 2019 are consistent with those discussed in Note 2 to the consolidated financial statements included in the Company’s 2018 Annual Report on Form 10-K, except as noted below with respect to the Company’s lease accounting policies and as noted within the “Recent accounting pronouncements – Recently adopted” |
Leases | Leases Effective January 1, 2019, the Company adopted ASU 2016-02, Leases (Topic 842), At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable. The Company does not have material financing leases. Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. To estimate its incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have a rating agency-based credit rating. Prospectively, the Company will adjust the right-of-use assets for straight-line rent expense or any incentives received and remeasure the lease liability at the net present value using the same incremental borrowing rate that was in effect as of the lease commencement or transition date. The Company has elected not to recognize leases with an original term of one year or less on the balance sheet. The Company typically only includes an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. ASC 842 transition practical expedients and application of transition provisions to leases at the transition date The Company elected the following practical expedients, which must be elected as a package and applied consistently to all of its leases at the transition date (including those for which the entity is a lessee or a lessor): i) the Company did not reassess whether any expired or existing contracts are or contain leases; ii) the Company did not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with ASC 840 are classified as operating leases, and all existing leases that were classified as capital leases in accordance with ASC 840 are classified as finance leases); and iii) the Company did not reassess initial direct costs for any existing leases. For leases that existed prior to the date of initial application of ASC 842 (which were previously classified as operating leases), a lessee may elect to use either the total lease term measured at lease inception under ASC 840 or the remaining lease term as of the date of initial application of ASC 842 in determining the period for which to measure its incremental borrowing rate. In transition to ASC 842, the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates. Application of ASC 842 policy elections to leases post adoption The Company has made certain policy elections to apply to its leases executed post adoption, or subsequent to January 1, 2019, as further described below. In accordance with ASC 842, components of a lease should be split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. Entities may elect not to separate lease and non-lease components. Rather, entities would account for each lease component and related non-lease component together as a single lease component. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only. ASC 842 allows for the use of judgment in determining whether the assumed lease term is for a major part of the remaining economic life of the underlying asset and whether the present value of lease payments represents substantially all of the fair value of the underlying asset. The Company applies the bright line thresholds referenced in ASC 842-10-55-2 to assist in evaluating leases for appropriate classification. The aforementioned bright lines are applied consistently to the Company’s entire portfolio of leases. |
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 |
Recent accounting pronouncements | Recent accounting pronouncements Recently adopted ASU No. 2016-02, Leases (Topic 842), ASU No. 2018-10 Codification Improvements to Topic 842, Leases, ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, and ASU No. 2019-01 Leases (Topic 842): Codification Improvements In February 2016, the FASB issued ASU 2016-02, as amended, which superseded the lease accounting requirements in ASC 840 and created ASC 842. ASC 842 requires a lessee to recognize assets and liabilities on the balance sheet for most leases and changes many key definitions, including the definition of a lease. The new standard includes a short-term lease exception for leases with a term of one year or less, as part of which a lessee can make an accounting policy election not to recognize lease assets and lease liabilities for those leases. Lessees will continue to differentiate between finance leases (previously referred to as capital leases) and operating leases using classification criteria that are substantially similar to the previous guidance. Effective January 1, 2019, the Company adopted ASU 2016-02, using the required modified retrospective approach and utilizing the effective date as its date of initial application. As a result, prior periods are presented in accordance with the previous guidance in ASC 840. The adoption of this standard resulted in the recognition of operating lease right-of-use assets and operating lease liabilities of $184.4 million and $177.0 million, respectively, on the Company’s condensed consolidated balance sheet at adoption relating to its leases for its corporate headquarters at 60 Binney Street in Cambridge, Massachusetts (the “60 Binney Street Lease”), its office and laboratory space in Seattle, Washington, its office space in Zug, Switzerland, and its embedded leases associated with certain of the Company’s contract manufacturing agreements. The application of the standard’s transition guidance required the de-recognition of the 60 Binney Street Lease building asset, financing lease obligation, current portion, and financing lease obligation, net of current portion in the amounts of $149.3 million, $1.4 million, and $153.3 million, respectively, as well as certain other adjustments to related account balances. In adopting ASU 2016-02, the Company recorded a total one-time adjustment of $6.6 million to the opening balance of accumulated deficit as of January 1, 2019 primarily relating to the de-recognition of the 60 Binney Street Lease building asset and related finance lease obligation. As a result of adopting ASU 2016-02, the Company recorded an increase to deferred tax assets and deferred tax liabilities of $5.3 million and $7.1 million, respectively. The $1.8 million net increase to deferred tax liabilities and an offsetting valuation allowance adjustment was recorded through the accumulated deficit as of January 1, 2019, such that there was no tax impact on the Company’s condensed consolidated financial statements as a result of adoption. ASU No. 2017-08, Receivables – Nonrefundable Fees and Other Costs (Topic 310-20): Premium Amortization on Purchased Callable Debt Securities In April 2017, the FASB issued ASU 2017-08, Receivables – Nonrefundable Fees and Other Costs (Topic 310-20): Premium Amortization on Purchased Callable Debt Securities (“Subtopic 310-20”) Subtopic 310-20 calls for a modified retrospective application under which . The Company adopted this standard on January 1, 2019 and it did not financial position or results of operations upon adoption. ASU No. 2018-02, Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income In February 2018, the FASB issued ASU 2018-02, Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income The Company adopted this standard on January 1, 2019 and it did not have a material impact on the Company’s financial position and results of operations Not yet adopted ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 362): Measurement of Credit Losses on Financial Statements, ASU No. 2019-05 Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 362): Measurement of Credit Losses on Financial Statements ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment In January 2017, the FASB issued ASU 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, (“ASU 2018-13”). ASU No. 2018-15, Intangibles-Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract, (“ASU 2018-15”) ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”) ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments In April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, (“ASU 2019-04”). financial position or results of operations upon adoption. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Marketable Securities Held | The following table summarizes the marketable securities held at June 30, 2019 and December 31, 2018 (in thousands): Description Amortized cost / Cost Unrealized gains Unrealized losses Fair value June 30, 2019 U.S. government agency securities and treasuries $ 1,060,606 $ 3,084 $ (519 ) $ 1,063,171 Certificates of deposit 4,520 — — 4,520 Corporate bonds 113,820 633 (12 ) 114,441 Commercial paper 62,692 — — 62,692 Equity securities 20,017 — (4,034 ) 15,983 Total $ 1,261,655 $ 3,717 $ (4,565 ) $ 1,260,807 December 31, 2018 U.S. government agency securities and treasuries $ 1,459,649 $ 963 $ (3,011 ) $ 1,457,601 Certificates of deposit 9,080 — — 9,080 Equity securities 20,017 2,150 — 22,167 Total $ 1,488,746 $ 3,113 $ (3,011 ) $ 1,488,848 |
Fair value measurements (Tables
Fair value measurements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
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, 2019 and December 31, 2018 (in thousands): Description Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) June 30, 2019 Assets: Cash and cash equivalents $ 280,995 $ 280,995 $ — $ — Marketable securities: U.S. government agency securities and treasuries 1,063,171 — 1,063,171 — Certificates of deposit 4,520 — 4,520 — Commercial paper 62,692 — 62,692 — Corporate bonds 114,441 — 114,441 — Equity securities 15,983 15,983 — — Total assets $ 1,541,802 $ 296,978 $ 1,244,824 $ — Liabilities: Contingent consideration $ 5,740 $ — $ — $ 5,740 Total liabilities $ 5,740 $ — $ — $ 5,740 December 31, 2018 Assets: Cash and cash equivalents $ 402,579 $ 348,638 $ 53,941 $ — Marketable securities: U.S. government agency securities and treasuries 1,457,601 — 1,457,601 — Certificates of deposit 9,080 — 9,080 — Equity securities 22,167 22,167 — — Total assets $ 1,891,427 $ 370,805 $ 1,520,622 $ — Liabilities: Contingent consideration $ 5,230 $ — $ — $ 5,230 Total liabilities $ 5,230 $ — $ — $ 5,230 |
Roll-Forward of Fair Value of the Company's Contingent Consideration Obligations | The table below provides a roll-forward of fair value of the Company’s contingent consideration obligations, which include Level 3 inputs (in thousands): For the six months ended June 30, 2019 Beginning balance $ 5,230 Additions — Changes in fair value 510 Payments — Ending balance $ 5,740 |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
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 As of June 30, 2019 December 31, 2018 Land $ 1,210 $ 1,210 Building 14,913 180,094 Computer equipment and software 6,518 6,365 Office equipment 6,308 5,584 Laboratory equipment 40,953 35,693 Leasehold improvements 21,598 183 Construction-in-progress 67,470 46,669 Total property, plant and equipment 158,970 275,798 Less accumulated depreciation and amortization (29,835 ) (29,176 ) Property, plant and equipment, net $ 129,135 $ 246,622 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
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 As of June 30, 2019 December 31, 2018 Employee compensation $ 22,638 $ 28,567 Accrued manufacturing costs 20,497 21,618 Accrued clinical and contract research organization costs 16,035 11,891 Accrued property, plant, and equipment 6,113 5,451 Accrued license and milestone fees 1,690 7,739 Accrued professional fees 1,497 1,830 Financing lease obligation, current portion — 1,424 Other 22,635 20,873 Total accrued expenses and other current liabilities $ 91,105 $ 99,393 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Summary of Lease Costs and Other Information Pertaining to Operating Leases | The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases for the three and six months ended June 30, 2019: Operating leases For the three months ended For the six months ended (in thousands) June 30, 2019 June 30, 2019 Lease cost (1) Operating lease cost $ 8,917 $ 17,400 Total lease cost $ 8,917 $ 17,400 Other information Operating cash flows used for operating leases $ 13,237 Weighted average remaining lease term 7.7 years Weighted average discount rate 6.17 % (1) Short-term lease costs and variable lease costs incurred by the Company for the three and six months ended June 30, 2019 were immaterial. |
Schedule of Future Minimum Commitments Under Operating Leases | As of June 30, 2019, future minimum commitments under ASC 842 under the Company’s operating leases were as follows: Maturity of lease liabilities As of (in thousands) June 30, 2019 2019 (excluding the six months ended June 30, 2019) $ 17,031 2020 33,780 2021 34,215 2022 29,417 2023 29,869 2024 and thereafter 108,687 Total lease payments 252,999 Less: imputed interest (58,777 ) Total operating lease liabilities $ 194,222 |
Collaborative arrangements (Tab
Collaborative arrangements (Tables) - Celgene Corporation [Member] | 6 Months Ended |
Jun. 30, 2019 | |
Changes in Balances of Company's Receivables and Contract Liabilities | The following table presents changes in the balances of the Company’s Celgene receivables and contract liabilities during the six months ended June 30, 2019: (in thousands) Balance at beginning of period Additions Deductions Balance at end of period Receivables $ 6,528 $ 10,450 $ (6,528 ) $ 10,450 Contract liabilities: Payable included in accrued expenses $ — $ 3,781 $ — $ 3,781 Deferred revenue $ 34,939 $ 10,000 $ (21,716 ) $ 23,223 |
U.S. [Member] | |
Summary of Revenue Recognized or Expense Incurred for Joint Ide-cel Development Efforts Related to Combined Unit of Accounting for its License and Vector Manufacturing of bb2121 | The following table summarizes the net collaboration revenue recognized or expense incurred for the joint ide-cel development efforts in the U.S. under ASC 808, including revenue or expense related to the combined performance obligation for the license and vector manufacturing of ide-cel for development in the U.S., for the three and six months ended June 30, 2019, and 2018: For the three months ended June 30, For the six months ended June 30, (in thousands) 2019 2018 2019 2018 ASC 808 ide-cel revenue - U.S. (1) $ — $ — $ — $ 3,761 ASC 808 ide-cel research and development expense - U.S. (1) $ (1,065 ) $ (3,349 ) $ (4,309 ) $ (3,349 ) (1) As noted above, the calculation of collaboration revenue or research and development expense to be recognized for joint ide-cel development efforts in the U.S. is performed on a quarterly basis. The calculation is independent of previous activity, which may result in fluctuations between revenue and expense recognition period over period, depending on the varying extent of effort performed by each party during the period. |
Outside of U.S. [Member] | |
Summary of Revenue Recognized or Expense Incurred for Joint Ide-cel Development Efforts Related to Combined Unit of Accounting for its License and Vector Manufacturing of bb2121 | The following table summarizes the revenue recognized related to the combined unit of accounting for the ide-cel non-US license and vector manufacturing services for the three and six months ended June 30, 2019, and 2018: For the three months ended June 30, For the six months ended June 30, (in thousands) 2019 2018 2019 2018 ASC 606 ide-cel license and manufacturing revenue - outside of U.S. $ 7,899 $ 5,764 $ 16,963 $ 14,706 |
Ide-cel Transaction Price [Member] | |
Summary of Total Transaction Price, Allocation of Total Transaction Price to Identified Performance Obligations Under Arrangement and Amount of Transaction Price Unsatisfied | The following tables summarize the total transaction price, the allocation of the total transaction price to the identified performance obligations under the arrangement, and the amount of the transaction price unsatisfied as of June 30, 2019: (in thousands) Ide-cel transaction price as of June 30, 2019 Up-front non-refundable payment - Celgene Collaboration Agreement $ 75,000 Up-front non-refundable payment - Amended Celgene Collaboration Agreement 25,000 Ide-cel license fee - Ide-cel License Agreement 10,000 Ide-cel development milestone 10,000 Estimated variable consideration 87,189 $ 207,189 (in thousands) Allocation of transaction price to performance obligations Transaction price unsatisfied as of June 30, 2019 Ide-cel research and development services $ 40,912 $ — Ide-cel license and manufacturing services 166,277 26,723 $ 207,189 $ 26,723 |
Ide-cel Research and Development Services [Member] | |
Summary of Revenue Recognized or Revenue Adjustment Recorded Related to Research and Development Services | The following table summarizes the revenue recognized, or revenue adjustment recorded, related to the ide-cel research and development services for the three and six months ended June 30, 2019 and 2018: For the three months ended June 30, For the six months ended June 30, (in thousands) 2019 2018 2019 2018 Ide-cel research and development services revenue $ 2,473 $ 953 $ 2,264 $ 3,136 $ 2,473 $ 953 $ 2,264 $ 3,136 |
bb21217 Transaction Price [Member] | |
Summary of Total Transaction Price, Allocation of Total Transaction Price to Identified Performance Obligations Under Arrangement and Amount of Transaction Price Unsatisfied | The following tables summarize the total transaction price, the allocation of the total transaction price to the identified performance obligations under the arrangement, and the amount of the transaction price unsatisfied as of June 30, 2019: (in thousands) bb21217 transaction price as of June 30, 2019 bb21217 license fee - bb21217 License Agreement $ 15,000 Estimated variable consideration 26,687 $ 41,687 (in thousands) Allocation of transaction price to performance obligations Transaction price unsatisfied as of June 30, 2019 bb21217 research and development services $ 5,444 $ 721 bb21217 license and manufacturing services 36,243 36,243 $ 41,687 $ 36,964 |
bb21217 Research and Development Services [Member] | |
Summary of Revenue Recognized or Revenue Adjustment Recorded Related to Research and Development Services | The following table summarizes the revenue recognized related to the bb21217 research and development services for the three and six months ended June 30, 2019, and 2018: For the three months ended June 30, For the six months ended June 30, (in thousands) 2019 2018 2019 2018 bb21217 research and development services revenue $ 721 $ 721 $ 1,442 $ 1,442 $ 721 $ 721 $ 1,442 $ 1,442 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Stock-Based Compensation Expense by Award Type | Stock-based compensation expense by award type included within the condensed consolidated statements of operations and comprehensive loss was as follows: For the For the three months ended June 30, six months ended June 30, (in thousands) 2019 2018 2019 2018 Stock options $ 24,800 $ 20,932 $ 47,983 $ 38,227 Restricted stock units 30,012 6,953 38,893 12,494 Employee stock purchase plan 299 171 576 330 $ 55,111 $ 28,056 $ 87,452 $ 51,051 |
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: For the For the three months ended June 30, six months ended June 30, (in thousands) 2019 2018 2019 2018 Research and development $ 29,694 $ 14,196 $ 45,210 $ 25,820 General and administrative 25,417 13,860 42,242 25,231 $ 55,111 $ 28,056 $ 87,452 $ 51,051 |
Summary of Stock Option Activity Under Plan | The following table summarizes the stock option activity under the Company’s equity award plans: Shares (in thousands) Weighted- average exercise price per share Outstanding at December 31, 2018 4,643 $ 108.56 Granted 1,266 $ 136.17 Exercised (282 ) $ 47.80 Canceled, forfeited, or expired (234 ) $ 129.85 Outstanding at June 30, 2019 5,393 $ 117.30 Exercisable at June 30, 2019 2,520 $ 88.94 Vested and expected to vest at June 30, 2019 5,393 $ 117.30 |
Restricted Stock Units [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Restricted Common Stock Awards | The following table summarizes the restricted stock unit activity under the Company’s equity award plans: Shares (in thousands) Weighted- average grant date fair value Unvested balance at December 31, 2018 931 $ 155.99 Granted 438 $ 136.32 Vested (197 ) $ 142.82 Forfeited (69 ) $ 153.94 Unvested balance at June 30, 2019 1,103 $ 150.67 |
Net loss per share (Tables)
Net loss per share (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
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: For the three and six months ended June 30, (in thousands) 2019 2018 Outstanding stock options 5,393 4,505 Restricted stock units 1,103 931 ESPP shares 15 5 6,511 5,441 |
Description of the business - A
Description of the business - Additional Information (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Date of incorporation | Apr. 16, 1992 |
Cash, cash equivalents and marketable securities | $ 1,540 |
Basis of presentation, princi_3
Basis of presentation, principles of consolidation and significant accounting policies - Additional Information (Detail) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2019USD ($)Segment | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | |
Basis Of Presentation And Significant Accounting Policies [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Operating lease liabilities | $ 194,222 | $ 125,800 | |
Operating lease right-of-use assets | 190,979 | $ 127,300 | |
Financing lease obligation, current portion | $ 1,424 | ||
ASU 2016-02 [Member] | |||
Basis Of Presentation And Significant Accounting Policies [Line Items] | |||
Increase to deferred tax assets | 5,300 | ||
Increase to deferred tax liabilities | 7,100 | ||
Net increase to deferred tax liabilities | 1,800 | ||
ASU 2016-02 [Member] | 60 Binney Street [Member] | |||
Basis Of Presentation And Significant Accounting Policies [Line Items] | |||
Operating lease liabilities | 177,000 | ||
Operating lease right-of-use assets | 184,400 | ||
Financing lease obligation | 149,300 | ||
Financing lease obligation, current portion | 1,400 | ||
Financing lease obligation, net of current portion | 153,300 | ||
Adjustment on accumulated deficit | $ 6,600 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities Held (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Schedule Of Available For Sale Securities [Line Items] | ||
Equity Securities, Amortized cost / Cost | $ 20,017 | $ 20,017 |
Equity Securities, Unrealized gains | 2,150 | |
Equity Securities, Unrealized losses | (4,034) | |
Equity Securities, Fair value | 15,983 | 22,167 |
Marketable Securities, Amortized cost / Cost | 1,261,655 | 1,488,746 |
Marketable Securities, Unrealized gains | 3,717 | 3,113 |
Marketable Securities, Unrealized losses | (4,565) | (3,011) |
Marketable Securities, Fair value | 1,260,807 | 1,488,848 |
U.S. Government Agency Securities and Treasuries [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Debt Securities. Amortized cost / Cost | 1,060,606 | 1,459,649 |
Debt Securities, Unrealized gains | 3,084 | 963 |
Debt Securities, Unrealized losses | (519) | (3,011) |
Debt Securities, Fair value | 1,063,171 | 1,457,601 |
Certificates of Deposit [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Debt Securities. Amortized cost / Cost | 4,520 | 9,080 |
Debt Securities, Fair value | 4,520 | $ 9,080 |
Corporate Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Debt Securities. Amortized cost / Cost | 113,820 | |
Debt Securities, Unrealized gains | 633 | |
Debt Securities, Unrealized losses | (12) | |
Debt Securities, Fair value | 114,441 | |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Debt Securities. Amortized cost / Cost | 62,692 | |
Debt Securities, Fair value | $ 62,692 |
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, 2019 | Dec. 31, 2018 |
Assets: | ||
Marketable Securities, Fair value | $ 1,260,807 | $ 1,488,848 |
Equity Securities, Fair value | 15,983 | 22,167 |
Liabilities: | ||
Contingent consideration | 5,740 | 5,230 |
Fair Value, Measurements, Recurring [Member] | ||
Assets: | ||
Cash and cash equivalents | 280,995 | 402,579 |
Equity Securities, Fair value | 15,983 | 22,167 |
Total assets | 1,541,802 | 1,891,427 |
Liabilities: | ||
Contingent consideration | 5,740 | 5,230 |
Total liabilities | 5,740 | 5,230 |
Fair Value, Measurements, Recurring [Member] | U.S. Government Agency Securities and Treasuries [Member] | ||
Assets: | ||
Marketable Securities, Fair value | 1,063,171 | 1,457,601 |
Fair Value, Measurements, Recurring [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Marketable Securities, Fair value | 4,520 | 9,080 |
Fair Value, Measurements, Recurring [Member] | Commercial Paper [Member] | ||
Assets: | ||
Marketable Securities, Fair value | 62,692 | |
Fair Value, Measurements, Recurring [Member] | Corporate Bonds [Member] | ||
Assets: | ||
Marketable Securities, Fair value | 114,441 | |
Fair Value, Measurements, Recurring [Member] | Quoted prices in active markets (Level 1) [Member] | ||
Assets: | ||
Cash and cash equivalents | 280,995 | 348,638 |
Equity Securities, Fair value | 15,983 | 22,167 |
Total assets | 296,978 | 370,805 |
Fair Value, Measurements, Recurring [Member] | Significant other observable inputs (Level 2) [Member] | ||
Assets: | ||
Cash and cash equivalents | 53,941 | |
Total assets | 1,244,824 | 1,520,622 |
Fair Value, Measurements, Recurring [Member] | Significant other observable inputs (Level 2) [Member] | U.S. Government Agency Securities and Treasuries [Member] | ||
Assets: | ||
Marketable Securities, Fair value | 1,063,171 | 1,457,601 |
Fair Value, Measurements, Recurring [Member] | Significant other observable inputs (Level 2) [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Marketable Securities, Fair value | 4,520 | 9,080 |
Fair Value, Measurements, Recurring [Member] | Significant other observable inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Assets: | ||
Marketable Securities, Fair value | 62,692 | |
Fair Value, Measurements, Recurring [Member] | Significant other observable inputs (Level 2) [Member] | Corporate Bonds [Member] | ||
Assets: | ||
Marketable Securities, Fair value | 114,441 | |
Fair Value, Measurements, Recurring [Member] | Significant unobservable inputs (Level 3) [Member] | ||
Liabilities: | ||
Contingent consideration | 5,740 | 5,230 |
Total liabilities | $ 5,740 | $ 5,230 |
Fair value measurements - Addit
Fair value measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Cash equivalents maturities | 90 days or less | ||||
Realized gain (loss) on available-for-sale securities | $ 0 | $ 0 | $ 0 | $ 0 | |
Reclassification out of accumulated other comprehensive loss | 0 | $ 0 | 0 | $ 0 | |
Unrealized loss on securities, less than twelve months | 52,400,000 | 52,400,000 | $ 787,500,000 | ||
Unrealized loss on securities, more than twelve months | 229,200,000 | 229,200,000 | 315,300,000 | ||
Unrealized loss on securities for less than twelve months | 100,000 | 100,000 | 900,000 | ||
Unrealized loss on securities for more than twelve months | 500,000 | 500,000 | 2,100,000 | ||
Investments with other-than-temporary impairment | 0 | 0 | 0 | ||
Investment at fair value | 15,983,000 | $ 15,983,000 | $ 22,167,000 | ||
Minimum [Member] | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Milestone achievement period | 2021 | ||||
Milestone discount rates | 14.20% | ||||
Maximum [Member] | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Milestone achievement period | 2028 | ||||
Milestone discount rates | 15.00% | ||||
Other (Expense) Income, Net [Member] | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Unrealized loss on equity securities | $ 3,100,000 | $ 6,200,000 |
Fair value measurements - Roll-
Fair value measurements - Roll-Forward of Fair Value of the Company's Contingent Consideration Obligations (Detail) - Significant unobservable inputs (Level 3) [Member] - Contingent consideration obligations [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Beginning balance | $ 5,230 |
Changes in fair value | 510 |
Ending balance | $ 5,740 |
Property, plant and equipment_3
Property, plant and equipment, net - Summary of Property, Plant and Equipment Net (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | $ 158,970 | $ 275,798 |
Less accumulated depreciation and amortization | (29,835) | (29,176) |
Property, plant and equipment, net | 129,135 | 246,622 |
Land [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 1,210 | 1,210 |
Building [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 14,913 | 180,094 |
Computer Equipment and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 6,518 | 6,365 |
Office Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 6,308 | 5,584 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 40,953 | 35,693 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 21,598 | 183 |
Construction in Progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | $ 67,470 | $ 46,669 |
Property, plant and equipment_4
Property, plant and equipment, net - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 158,970 | $ 275,798 |
Accumulated depreciation | 29,835 | 29,176 |
Construction In Progress North Carolina Manufacturing Facility [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 63,700 | $ 40,400 |
60 Binney Street [Member] | ASU 2016-02 [Member] | ||
Property Plant And Equipment [Line Items] | ||
De-recognized of building asset | 156,000 | |
Accumulated depreciation | $ 6,700 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Employee compensation | $ 22,638 | $ 28,567 |
Accrued manufacturing costs | 20,497 | 21,618 |
Accrued clinical and contract research organization costs | 16,035 | 11,891 |
Accrued property, plant, and equipment | 6,113 | 5,451 |
Accrued license and milestone fees | 1,690 | 7,739 |
Accrued professional fees | 1,497 | 1,830 |
Financing lease obligation, current portion | 1,424 | |
Other | 22,635 | 20,873 |
Total accrued expenses and other current liabilities | $ 91,105 | $ 99,393 |
Leases - Additional Information
Leases - Additional Information (Detail) | Jun. 03, 2016USD ($) | Sep. 21, 2015USD ($)ft²$ / ft² | Apr. 30, 2019USD ($)ft²$ / ft² | Jun. 30, 2019USD ($) | Jan. 01, 2019USD ($) |
Lessee Lease Description [Line Items] | |||||
Operating lease, right-of-use asset | $ 190,979,000 | $ 127,300,000 | |||
Operating lease, liability | $ 194,222,000 | $ 125,800,000 | |||
Building [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Useful life of asset | 40 years | ||||
50 Binney Street Sublease [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lease rent, annual increase percentage | 3.00% | ||||
Sublease rent description | Under the terms of the 50 Binney Street Sublease, the Company will lease 267,278 square feet of office space for $99.95 per square foot, or $26.7 million per year in base rent subject to certain operating expenses, taxes and annual rent increases of approximately 3%. The lease will commence when the space is available for use by the Company, which is anticipated to be July 1, 2021, and end on December 31, 2030, unless the Company earlier occupies the premises or other conditions specified in the 50 Binney Street Sublease occur. The sublessor has the right to postpone the commencement date until January 1, 2022 by providing not less than nine months’ prior written notice to the Company. | ||||
Area of office space for sublease | ft² | 267,278 | ||||
Rate of area for sublease per square feet | $ / ft² | 99.95 | ||||
Sublease annual base rent | $ 26,700,000 | ||||
Sublease rent payments | Payments will commence at the earlier of (i) the date which is 90 days following the commencement date and (ii) the date the Company takes occupancy of all or any portion of the premises | ||||
50 Binney Street Sublease [Member] | Cash-Collateralized Letter of Credit [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Collateralized letter of credit | 40,100,000 | ||||
50 Binney Street Sublease [Member] | Cash-Collateralized Letter of Credit [Member] | Restricted Cash and Other Non-current Assets [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Collateralized letter of credit | $ 40,100,000 | ||||
Furniture Purchase Agreement [Member] | Restricted Cash and Other Non-current Assets [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Upfront payment for purchase of furniture and equipment | $ 7,500,000 | ||||
Manufacturing Agreement [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lease period | 12 years | ||||
Milestone paid | $ 12,000,000 | ||||
Lease payments | $ 5,100,000 | ||||
Agreement termination description | The Company may terminate this agreement at any time upon payment of a one-time termination fee and up to 24 months of fixed suite and labor fees. | ||||
Early termination lease term | 24 months | ||||
Manufacturing Agreement [Member] | Maximum [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Additional contractual payables to milestones | $ 8,000,000 | ||||
Lease starting on October 1, 2016 [Member] | 60 Binney Street Lease [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lease period | 10 years | ||||
Lease starting date | Oct. 1, 2016 | ||||
Lease building space | ft² | 253,108 | ||||
Annual lease rent per square foot | $ / ft² | 72.50 | ||||
Lease payments base annual rent | $ 18,400,000 | ||||
Operating lease description | Under the terms of the 60 Binney Street Lease, starting on October 1, 2016, the Company leases approximately 253,108 square feet of office and laboratory space at $72.50 per square foot per year, or $18.4 million per year in base rent, which is subject to scheduled annual rent increases of 1.75% plus certain operating expenses and taxes. | ||||
Lease rent, annual increase percentage | 1.75% | ||||
Collateralized letter of credit | $ 13,800,000 | ||||
Landlord contribution for cost of construction and tenant improvements | 42,400,000 | ||||
Decrease in letter of credit under the terms of the lease | $ 9,200,000 | ||||
Lease expiration date | Mar. 31, 2027 | ||||
Lease extension terms | two successive five-year terms |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs and Other Information Pertaining to Operating Leases (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) | |
Lease cost | ||
Operating lease cost | $ 8,917 | $ 17,400 |
Total lease cost | $ 8,917 | 17,400 |
Operating cash flows used for operating leases | $ 13,237 | |
Weighted average remaining lease term | 7 years 8 months 12 days | 7 years 8 months 12 days |
Weighted average discount rate | 6.17% | 6.17% |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Commitments Under Operating Leases (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 |
Leases [Abstract] | ||
2019 (excluding the six months ended June 30, 2019) | $ 17,031 | |
2020 | 33,780 | |
2021 | 34,215 | |
2022 | 29,417 | |
2023 | 29,869 | |
2024 and thereafter | 108,687 | |
Total lease payments | 252,999 | |
Less: imputed interest | (58,777) | |
Total operating lease liabilities | $ 194,222 | $ 125,800 |
Commitments and contingencies -
Commitments and contingencies - Additional Information (Detail) - Pregenen [Member] $ in Millions | Jun. 30, 2019USD ($) |
Commitments And Contingencies Disclosure [Line Items] | |
Contingent cash payments | $ 120 |
Clinical Milestone Payments [Member] | |
Commitments And Contingencies Disclosure [Line Items] | |
Contingent cash payments | 20.1 |
Commercial Milestones Payments [Member] | |
Commitments And Contingencies Disclosure [Line Items] | |
Contingent cash payments | $ 99.9 |
Collaborative arrangements - Ad
Collaborative arrangements - Additional Information (Detail) | Aug. 24, 2018USD ($)Target$ / sharesshares | Sep. 28, 2017USD ($) | Feb. 16, 2016USD ($) | Mar. 19, 2013USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($)shares | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Aug. 03, 2018USD ($) | Mar. 28, 2018USD ($) | Jun. 03, 2015USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Deferred revenue released | $ 21,700,000 | |||||||||||
Investment in common stock | $ 48,702,000 | |||||||||||
Research and Development Services [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Deferred revenue balance recognized as gross revenues | 11,700,000 | |||||||||||
Research and Development Services [Member] | Collaboration [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Deferred revenue balance recognized as gross revenues | 10,000,000 | |||||||||||
Celgene Corporation [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Contract with customer liability | $ 23,223,000 | 23,223,000 | $ 34,939,000 | |||||||||
Term of collaboration agreement | 3 years | |||||||||||
Deferred revenue balance recognized as gross revenues | 21,716,000 | |||||||||||
Celgene Corporation [Member] | Collaborative Arrangement [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Contract with customer liability | $ 75,000,000 | |||||||||||
Celgene Corporation [Member] | Amended Collaborative Arrangement [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Contract with customer liability | $ 25,000,000 | |||||||||||
Estimated variable consideration | 87,200,000 | $ 87,200,000 | ||||||||||
Deferred revenue recognition period | 3 years | |||||||||||
Celgene Corporation [Member] | Amended Collaborative Arrangement [Member] | Research and Development Services [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Collaboration agreement, transaction price | 40,900,000 | $ 40,900,000 | ||||||||||
Celgene Corporation [Member] | Ide-cel License Agreement [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Collaboration agreement, option fee received | 10,000,000 | |||||||||||
Celgene Corporation [Member] | Ide-cel License Agreement [Member] | First Product Candidates [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Collaboration agreement, option fee received | $ 10,000,000 | |||||||||||
Celgene Corporation [Member] | Ide-cel Co-Development, Co-Promote and Profit Share Agreement [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Development milestone payments achieved | 10,000,000 | |||||||||||
Remaining potential development milestone payment receivable | 60,000,000 | 60,000,000 | ||||||||||
Celgene Corporation [Member] | Ide-cel Co-Development, Co-Promote and Profit Share Agreement [Member] | Maximum [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Development milestone payments receivable | $ 70,000,000 | |||||||||||
Celgene Corporation [Member] | bb21217 License Agreement [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Collaboration agreement, option fee received | $ 15,000,000 | 15,000,000 | ||||||||||
Additional fee receivable if option to co-develop and co-promote is not exercised | $ 10,000,000 | |||||||||||
Estimated variable consideration | 26,700,000 | $ 26,700,000 | ||||||||||
Deferred revenue recognition period | 2 years | |||||||||||
Celgene Corporation [Member] | bb21217 License Agreement [Member] | Maximum [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Clinical milestone payments receivable | 10,000,000 | $ 10,000,000 | ||||||||||
Regulatory milestone payments receivable | 117,000,000 | 117,000,000 | ||||||||||
Commercial milestone payments receivable | 78,000,000 | 78,000,000 | ||||||||||
Celgene Corporation [Member] | bb21217 License Agreement [Member] | Research and Development Services [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Contract with customer liability | 700,000 | 700,000 | 1,800,000 | |||||||||
Collaboration agreement, transaction price | 5,400,000 | 5,400,000 | ||||||||||
Remaining performance obligation revenue | 700,000 | 700,000 | 1,800,000 | |||||||||
Celgene Corporation [Member] | bb21217 License Agreement [Member] | License and Manufacturing Services [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Contract with customer liability | 9,800,000 | 9,800,000 | 9,800,000 | |||||||||
Remaining performance obligation revenue | 36,200,000 | 36,200,000 | ||||||||||
Deferred revenue balance recognized as gross revenues | 0 | $ 0 | 0 | $ 0 | ||||||||
Celgene Corporation [Member] | bb21217 License Agreement, Co-promotion and Development [Member] | Maximum [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Development milestone payments receivable | 70,000,000 | 70,000,000 | ||||||||||
Celgene Corporation [Member] | Ide-cel License and Manufacturing Services [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Collaboration agreement, transaction price | 166,277,000 | 166,277,000 | ||||||||||
Remaining performance obligation revenue | 26,723,000 | 26,723,000 | ||||||||||
Celgene Corporation [Member] | Ide-cel License and Manufacturing Services [Member] | License and Manufacturing Services [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Contract with customer liability | 12,700,000 | 12,700,000 | 23,000,000 | |||||||||
Remaining performance obligation revenue | $ 26,700,000 | $ 26,700,000 | ||||||||||
Remaining performance obligation expected to be recognize as revenue, year | 2020 | 2020 | ||||||||||
Regeneron Collaboration Agreement [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Number of initial collaboration targets | Target | 6 | |||||||||||
Research collaboration term | 5 years | |||||||||||
Collaboration agreements costs and profits share description | Regeneron chooses to opt-in, the parties will share equally in the costs of development and commercialization, and will share equally in any profits or losses therefrom in applicable opt-in territories. | |||||||||||
Purchase price premium | $ 37,000,000 | |||||||||||
Collaboration research advancement remaining to be recognized | $ 41,500,000 | $ 41,500,000 | $ 44,000,000 | |||||||||
Regeneron Collaboration Agreement [Member] | Collaboration [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Deferred revenue balance recognized as gross revenues | 500,000 | $ 0 | 2,500,000 | $ 0 | ||||||||
Regeneron Collaboration Agreement [Member] | Maximum [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Milestone payments receivable | $ 130,000,000 | |||||||||||
Regeneron Collaboration Agreement [Member] | Research and Development Services [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Collaboration agreement, transaction price | 100,000,000 | 100,000,000 | ||||||||||
Purchase price premium | 37,000,000 | |||||||||||
Collaborative arrangement amount attributed to equity sold | 54,500,000 | 54,500,000 | ||||||||||
Collaborative arrangement amount attributed to joint research activities | $ 45,500,000 | $ 45,500,000 | ||||||||||
Collaborative arrangement amortization period | 5 years | |||||||||||
Regeneron Collaboration Agreement [Member] | Share Purchase Agreement [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Common stock shares issued | shares | 400,000 | 0.4 | ||||||||||
Investment in common stock | $ 100,000,000 | |||||||||||
Common stock price per share | $ / shares | $ 238.10 | |||||||||||
Purchase price premium | $ 37,000,000 | |||||||||||
Collaborative arrangement research initial funding obligation, percentage | 50.00% | |||||||||||
Regeneron Collaboration Agreement [Member] | Share Purchase Agreement [Member] | Common Shares [Member] | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Investment in common stock | $ 63,000,000 |
Collaborative arrangements - Su
Collaborative arrangements - Summary of Total Transaction Price, Allocation of Total Transaction Price to Identified Performance Obligations Under Arrangement and Amount of Transaction Price Unsatisfied (Detail) - Celgene Corporation [Member] - USD ($) $ in Thousands | Sep. 28, 2017 | Jun. 30, 2019 |
Collaborative Arrangement [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Up-front non-refundable payment | $ 75,000 | |
Amended Celgene Collaboration Agreement [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Up-front non-refundable payment | 25,000 | |
Ide-cel License Agreement [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration agreement, license fee | 10,000 | |
Ide-cel Co-Development, Co-Promote and Profit Share Agreement [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration agreement, development milestone | 10,000 | |
Vectors and Associated Payload [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Estimated variable consideration | 87,189 | |
Ide-cel Transaction Price [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration agreement, transaction price | 207,189 | |
Transaction price unsatisfied | 26,723 | |
Ide-cel Research and Development Services [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration agreement, transaction price | 40,912 | |
Ide-cel License and Manufacturing Services [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration agreement, transaction price | 166,277 | |
Transaction price unsatisfied | 26,723 | |
bb21217 License Agreement [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration agreement, license fee | $ 15,000 | 15,000 |
Estimated variable consideration | 26,700 | |
Manufacturing Services [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Estimated variable consideration | 26,687 | |
bb21217 Transaction Price [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration agreement, transaction price | 41,687 | |
Transaction price unsatisfied | 36,964 | |
bb21217 Research and Development Services [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration agreement, transaction price | 5,444 | |
Transaction price unsatisfied | 721 | |
bb21217 License and Manufacturing Services [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration agreement, transaction price | 36,243 | |
Transaction price unsatisfied | $ 36,243 |
Collaborative arrangements - _2
Collaborative arrangements - Summary of Revenue Recognized or Revenue Adjustment Recorded Related to Research and Development Services (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenue | $ 13,296 | $ 7,851 | $ 25,767 | $ 23,808 |
Celgene Corporation [Member] | Ide-cel Research and Development Services Revenue [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenue | $ 2,473 | $ 953 | $ 2,264 | $ 3,136 |
Collaborative arrangements - _3
Collaborative arrangements - Summary of Revenue Recognized or Expense Incurred for Joint Ide-cel Development Efforts Related to Combined Unit of Accounting for its License and Vector Manufacturing of Ide-cel (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenue | $ 13,296 | $ 7,851 | $ 25,767 | $ 23,808 |
Celgene Corporation [Member] | Ide-cel Research and Development Services [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenue | 2,473 | 953 | 2,264 | 3,136 |
Celgene Corporation [Member] | U.S. [Member] | Ide-cel Revenue Services [Member] | ASU 2014-09 [Member] | License and Manufacturing Services [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenue | 3,761 | |||
Celgene Corporation [Member] | U.S. [Member] | Ide-cel Research and Development Services [Member] | ASU 2014-09 [Member] | License and Manufacturing Services [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
License and manufacturing revenue (expense) | (1,065) | (3,349) | (4,309) | (3,349) |
Celgene Corporation [Member] | Outside of U.S. [Member] | Ide-cel License and Manufacturing Services [Member] | ASU 2014-09 [Member] | License and Manufacturing Services [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenue | $ 7,899 | $ 5,764 | $ 16,963 | $ 14,706 |
Collaborative arrangements - _4
Collaborative arrangements - Summary of Revenue Recognized Related to Research and Development Services (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenue | $ 13,296 | $ 7,851 | $ 25,767 | $ 23,808 |
Celgene Corporation [Member] | bb21217 Research and Development Services [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenue | $ 721 | $ 721 | $ 1,442 | $ 1,442 |
Collaborative arrangements - Ch
Collaborative arrangements - Changes in Balances of Company's Receivables and Contract Liabilities (Detail) - Celgene Corporation [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Receivables | |
Balance at beginning of period | $ 6,528 |
Additions | 10,450 |
Deductions | (6,528) |
Balance at end of period | 10,450 |
Contract liabilities: | |
Balance at beginning of period | 34,939 |
Additions | 10,000 |
Deductions | (21,716) |
Balance at end of period | 23,223 |
Accrued Expenses [Member] | |
Contract liabilities: | |
Additions | 3,781 |
Balance at end of period | $ 3,781 |
Equity - Additional Information
Equity - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 1 Months Ended | |
Jul. 31, 2018 | Jan. 31, 2018 | |
Subsidiary Sale Of Stock [Line Items] | ||
Number of shares issued in public offering | 0.3 | |
Shares issued, price per share | $ 185 | |
Proceeds from public offering of common stock, net of issuance costs | $ 48.7 | |
Inclusive of Shares Pursuant to Over Allotment Option Granted [Member] | ||
Subsidiary Sale Of Stock [Line Items] | ||
Number of shares issued in public offering | 3.9 | |
Shares issued, price per share | $ 162.50 | |
Proceeds from public offering of common stock, net of issuance costs | $ 600.6 |
Stock-based compensation - Addi
Stock-based compensation - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jan. 31, 2019 | Jan. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Jun. 03, 2013 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Increased number of issuance of awards under the 2013 Plan | 2,200,000 | 2,000,000 | ||||||
Number of shares available for issuance | 2,200,000 | 2,200,000 | ||||||
Stock-based compensation expense | $ 55,111 | $ 28,056 | $ 87,452 | $ 51,051 | ||||
Stock option share exercised | 282,000 | |||||||
Proceed from option share exercised | $ 13,500 | |||||||
Performance And Service Condition Based Restricted Stock Unit [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 20,100 | |||||||
Unvested restricted stock awards outstanding | 200,000 | 200,000 | ||||||
Performance And Service Condition Based Restricted Stock Unit [Member] | Tranche One [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Award vest, month and year | 2021-06 | |||||||
Stock Options [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 24,800 | 20,932 | $ 47,983 | 38,227 | ||||
Unrecognized stock- based compensation expense related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | 372,400 | $ 372,400 | ||||||
Expected weighted-average period related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | 2 years 9 months 18 days | |||||||
Restricted Stock Units [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 30,012 | 6,953 | $ 38,893 | 12,494 | ||||
Unvested restricted stock awards outstanding | 1,103,000 | 1,103,000 | 931,000 | |||||
Unrecognized stock- based compensation expense related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | $ 372,400 | $ 372,400 | ||||||
Expected weighted-average period related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | 2 years 9 months 18 days | |||||||
Performance-based Restricted Stock Units [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unrecognized stock- based compensation expense related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | 372,400 | $ 372,400 | ||||||
Expected weighted-average period related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | 2 years 9 months 18 days | |||||||
Employee Stock Purchase Plan [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | 299 | $ 171 | $ 576 | $ 330 | ||||
Unrecognized stock- based compensation expense related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | $ 372,400 | $ 372,400 | ||||||
Expected weighted-average period related to unvested stock options, restricted stock units, performance-based restricted stock units and employee stock purchase plan | 2 years 9 months 18 days | |||||||
Common shares reserved for future issuance | 200,000 | |||||||
Employee Stock Purchase Plan [Member] | Maximum [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares of common stock issued under plan | 100,000 | 100,000 |
Stock-based compensation - Summ
Stock-based compensation - Summary of Stock-Based Compensation Expense by Award Type (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 55,111 | $ 28,056 | $ 87,452 | $ 51,051 |
Stock Options [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 24,800 | 20,932 | 47,983 | 38,227 |
Restricted Stock Units [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 30,012 | 6,953 | 38,893 | 12,494 |
Employee Stock Purchase Plan [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 299 | $ 171 | $ 576 | $ 330 |
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, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 55,111 | $ 28,056 | $ 87,452 | $ 51,051 |
Research And Development [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 29,694 | 14,196 | 45,210 | 25,820 |
General And Administrative [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 25,417 | $ 13,860 | $ 42,242 | $ 25,231 |
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, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Outstanding at beginning of period | 4,643 |
Granted | 1,266 |
Exercised | (282) |
Canceled, forfeited, or expired | (234) |
Outstanding at end of period | 5,393 |
Exercisable at end of period | 2,520 |
Vested and expected to vest at end of period | 5,393 |
Outstanding at beginning of period | $ 108.56 |
Granted | 136.17 |
Exercised | 47.80 |
Canceled, forfeited, or expired | 129.85 |
Outstanding at end of period | 117.30 |
Exercisable at end of period | 88.94 |
Vested and expected to vest at end of period | $ 117.30 |
Stock-based compensation - Su_3
Stock-based compensation - Summary of Restricted Stock Units (Detail) - Restricted Stock Units [Member] shares in Thousands | 6 Months Ended |
Jun. 30, 2019$ / sharesshares | |
Shares | |
Unvested balance at beginning of period | shares | 931 |
Granted | shares | 438 |
Vested | shares | (197) |
Forfeited | shares | (69) |
Unvested balance at end of period | shares | 1,103 |
Weighted-average grant date fair value | |
Unvested balance at beginning of period | $ / shares | $ 155.99 |
Granted | $ / shares | 136.32 |
Vested | $ / shares | 142.82 |
Forfeited | $ / shares | 153.94 |
Unvested balance at end of period | $ / shares | $ 150.67 |
Net loss per share - Common Sto
Net loss per share - Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Common stock equivalents excluded from the calculation of diluted net loss per share | 6,511 | 5,441 | 6,511 | 5,441 |
Outstanding Stock Options [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Common stock equivalents excluded from the calculation of diluted net loss per share | 5,393 | 4,505 | 5,393 | 4,505 |
Restricted Stock Units [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Common stock equivalents excluded from the calculation of diluted net loss per share | 1,103 | 931 | 1,103 | 931 |
ESPP Shares [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Common stock equivalents excluded from the calculation of diluted net loss per share | 15 | 5 | 15 | 5 |