Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 26, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | BLUE | |
Entity Registrant Name | bluebird bio, Inc. | |
Entity Central Index Key | 1,293,971 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 54,694,411 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current Assets: | ||
Cash and cash equivalents | $ 952,137 | $ 758,505 |
Marketable securities | 723,141 | 531,604 |
Other investment and investment receivable | 20,017 | |
Tenant improvement receivable | 19 | 3,112 |
Prepaid expenses | 24,133 | 21,171 |
Receivables and other current assets | 5,901 | 8,377 |
Total current assets | 1,725,348 | 1,322,769 |
Marketable securities | 323,772 | 324,193 |
Property, plant and equipment, net | 232,863 | 199,606 |
Intangible assets, net | 14,109 | 16,931 |
Goodwill | 13,128 | 13,128 |
Restricted cash and other non-current assets | 42,569 | 23,940 |
Total assets | 2,351,789 | 1,900,567 |
Current Liabilities: | ||
Accounts payable | 12,891 | 12,873 |
Accrued expenses and other current liabilities | 88,335 | 57,065 |
Deferred revenue, current portion | 22,575 | 25,674 |
Collaboration research advancement, current portion | 7,842 | |
Total current liabilities | 131,643 | 95,612 |
Deferred revenue, net of current portion | 22,256 | 21,763 |
Collaboration research advancement, net of current portion | 37,676 | |
Contingent consideration | 3,074 | 2,231 |
Financing lease obligation, net of current portion | 153,716 | 154,749 |
Other non-current liabilities | 2,634 | 2,780 |
Total liabilities | 350,999 | 277,135 |
Commitments and contingencies (Note 8) | ||
Stockholders’ Equity: | ||
Preferred stock, $0.01 par value, 5,000 shares authorized; 0 shares issued and outstanding at September 30, 2018 and December 31, 2017 | ||
Common stock, $0.01 par value, 125,000 shares authorized; 54,678 and 49,406 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 547 | 494 |
Additional paid-in capital | 3,355,491 | 2,540,951 |
Accumulated other comprehensive loss | (5,463) | (4,205) |
Accumulated deficit | (1,349,785) | (913,808) |
Total stockholders’ equity | 2,000,790 | 1,623,432 |
Total liabilities and stockholders’ equity | $ 2,351,789 | $ 1,900,567 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 |
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 | 54,678,000 | 49,406,000 |
Common stock, shares outstanding | 54,678,000 | 49,406,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue: | ||||
Total revenues | $ 11,528 | $ 7,711 | $ 35,336 | $ 31,259 |
Operating expenses: | ||||
Research and development | 116,744 | 61,545 | 328,867 | 180,464 |
General and administrative | 44,527 | 22,982 | 120,621 | 64,463 |
Cost of license and royalty revenue | $ 29 | $ 1,100 | $ 67 | $ 1,520 |
Type of cost, good or service [Extensible List] | blue:LicenseAndRoyaltyMember | blue:LicenseAndRoyaltyMember | blue:LicenseAndRoyaltyMember | blue:LicenseAndRoyaltyMember |
Change in fair value of contingent consideration | $ 47 | $ (258) | $ 843 | $ 205 |
Total operating expenses | 161,347 | 85,369 | 450,398 | 246,652 |
Loss from operations | (149,819) | (77,658) | (415,062) | (215,393) |
Interest income (expense), net | 4,591 | (1,155) | 8,415 | (1,842) |
Other income (expense), net | (252) | 8 | 45 | (1,180) |
Loss before income taxes | (145,480) | (78,805) | (406,602) | (218,415) |
Net loss | $ (145,480) | $ (78,805) | $ (406,602) | $ (218,415) |
Net loss per share - basic and diluted: | $ (2.73) | $ (1.73) | $ (7.95) | $ (5.14) |
Weighted-average number of common shares used in computing net loss per share - basic and diluted: | 53,277 | 45,648 | 51,130 | 42,524 |
Other comprehensive loss: | ||||
Other comprehensive loss, net of tax expense of $0.0 and $0.0 million for the three and nine months ended September 30, 2018 and 2017, respectively | $ (66) | $ (683) | $ (1,255) | $ (949) |
Total other comprehensive loss | (66) | (683) | (1,255) | (949) |
Comprehensive loss | (145,546) | (79,488) | (407,857) | (219,364) |
Collaboration [Member] | ||||
Revenue: | ||||
Total revenues | 10,926 | 5,211 | 33,971 | 18,189 |
License and Royalty [Member] | ||||
Revenue: | ||||
Total revenues | $ 602 | $ 2,500 | $ 1,365 | $ 13,070 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Income Statement [Abstract] | ||||
Other comprehensive (loss) tax expense | $ 0 | $ 0 | $ 0 | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (406,602) | $ (218,415) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Change in fair value of contingent consideration | 843 | (1,460) |
Depreciation and amortization | 12,613 | 9,899 |
Stock-based compensation expense | 80,849 | 38,953 |
Other non-cash items | 3,106 | 2,545 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (19,014) | (12,865) |
Accounts payable | (493) | (447) |
Accrued expenses and other liabilities | 31,466 | (6,468) |
Deferred revenue | (31,981) | 3,084 |
Collaboration research advancement | 45,518 | |
Net cash used in operating activities | (283,695) | (185,174) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment, including assets under financing lease obligation | (42,844) | (43,408) |
Purchases of marketable securities | (827,163) | (621,004) |
Proceeds from maturities of marketable securities | 631,680 | 320,190 |
Purchase of other investment and investment receivable | (20,017) | |
Net cash used in investing activities | (258,344) | (344,222) |
Cash flows from financing activities: | ||
Proceeds from public offering of common stock, net of issuance costs | 649,367 | 436,805 |
Cash paid for contingent purchase price consideration | (1,074) | |
Reimbursement of assets under financing lease obligation | 3,098 | 38,021 |
Payments on financing lease obligation | (728) | (315) |
Proceeds from issuance of common stock | 29,550 | 14,406 |
Net cash provided by financing activities | 735,771 | 487,843 |
Increase (decrease) in cash, cash equivalents and restricted cash | 193,732 | (41,553) |
Cash, cash equivalents and restricted cash at beginning of period | 772,268 | 293,277 |
Cash, cash equivalents and restricted cash at end of period | 966,000 | 251,724 |
Supplemental cash flow disclosures from investing and financing activities: | ||
Purchases of property, plant and equipment included in accounts payable and accrued expenses | 2,770 | 1,740 |
Assets acquired under financing lease obligation | 2,467 | |
Stock option exercise proceeds receivable | 49 | 845 |
Tenant improvements under financing lease included in tenant improvements receivable | 14 | $ 2,013 |
Regeneron Collaboration Agreement [Member] | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | $ 54,484 |
Description of the business
Description of the business | 9 Months Ended |
Sep. 30, 2018 | |
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 researches, develops, manufactures and plans to commercialize gene therapies for the treatment of 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 clinical programs in severe genetic diseases include its LentiGlobin ® TM Collaborative arrangements As of September 30, 2018, the Company had cash, cash equivalents and marketable securities of $2.0 billion. Although the Company has incurred recurring losses and expects to continue to incur losses for the foreseeable future, the Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund current operations for at least the next twelve months. |
Basis of presentation, principl
Basis of presentation, principles of consolidation and significant accounting policies | 9 Months Ended |
Sep. 30, 2018 | |
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 September 30, 2018 and 2017. 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 financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2017, 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, 2018. 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. Principles of consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to GAAP. The Company views its operations and manages its business in one operating segment. All material long-lived assets of the Company reside in the United States. Significant accounting policies The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2018 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s 2017 Annual Report on Form 10-K, except as noted below with respect to the Company’s revenue recognition, collaboration revenue and license and royalty revenue accounting policies and as noted within the “Recent accounting pronouncements – Recently adopted” Revenue recognition Effective January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue generating arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied, either at a point in time or over time, and if over time recognition is based on the use of an output or input method. Collaboration revenue To date, the Company’s collaboration revenue has been exclusively generated from its collaboration arrangement with Celgene, which was originally entered into in March 2013 and was subsequently amended in June 2015, as further described in Note 9, “ Collaborative arrangements The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements License and royalty revenue The Company enters into out-licensing agreements that are within the scope of Topic 606. The Company does not have any material license arrangements that contain more than one performance obligation. The terms of such out-license agreements include the license of functional intellectual property, given the functionality of the intellectual property is not expected to change substantially as a result of the licensor’s ongoing activities, and typically include payment of one or more of the following: non-refundable up-front license fees; development and regulatory milestone payments and milestone payments based on the level of sales; and royalties on net sales of licensed products. Nonrefundable up-front license fees are recognized as revenue at a point in time when the licensed intellectual property is made available for the customer’s use and benefit, which is generally at the inception of the arrangement. Milestone fees, which are a type of variable consideration, are recognized as revenue to the extent that it is probable that a significant reversal will not occur. For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied. For a complete discussion of accounting for collaboration and other revenue-generating arrangements, see Note 9, “Collaborative arrangements” “License and royalty revenue” Recent accounting pronouncements - Recently adopted Share-based compensation The Company’s share-based compensation programs grant awards that have included stock options, restricted stock units, restricted stock awards, and shares issued under its employee stock purchase plan. Grants are awarded to employees, including directors, and non-employees. As noted in the Company’s 2017 Annual Report on Form 10-K, the Company historically applied the guidance in FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees, to account for its awards to non-employees pursuant to which the measurement date for non-employee awards was generally the date the services are completed, resulting in financial reporting period adjustments to stock-based compensation during the vesting terms for changes in the fair value of the awards. As discussed below under “Recently Adopted Accounting Pronouncements”, in the third quarter of 2018 the Company adopted ASU No. 2018-07, “ Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting 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. 2014 -09, In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers Revenue Recognition Revenue from Contracts with Customers • For contracts that were modified prior to Topic 606 adoption, the Company has not retrospectively accounted for each contract modification in accordance with the contract modification guidance. Instead, the Company reflected the aggregate effect of all modifications occurring prior to Topic 606 adoption when identifying the sa tisfied and unsatisfied performance obligations, determining the transaction price and allocating the transaction price. As a result of adopting Topic 606, the Company recorded a $29.4 million adjustment to the opening balance of accumulated deficit in the first quarter of 2018 primarily as a result of the accounting for the up-front consideration received in March 2013 in connection with the collaboration arrangement with Celgene under ASC 605-25 versus Topic 606. Refer below for a summary of t he amount by which each financial statement line item was affected by Impact of Topic 606 adoption on condensed consolidated balance sheet as of January 1, 2018 (in thousands) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Deferred revenue, current portion $ 45,344 $ 19,670 $ 25,674 Deferred revenue, net of current portion $ 31,468 $ 9,705 $ 21,763 Accumulated deficit $ (943,183 ) $ (29,375 ) $ (913,808 ) The amount by which each financial statement line item is affected in the current reporting period by Topic 606 as compared with the guidance that was in effect prior to adoption is disclosed below. Impact of Topic 606 adoption on condensed consolidated balance sheet as of September 30, 2018 (in thousands) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Deferred revenue, current portion $ 22,575 $ 9,596 $ 12,979 Deferred revenue, net of current portion $ 22,256 $ 6,074 $ 16,182 Accumulated deficit $ (1,349,785 ) $ 15,670 $ (1,365,455 ) Impact of Topic 606 adoption on condensed consolidated statement of operations and comprehensive loss for the three months ended September 30, 2018 (in thousands, except per share data) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Collaboration revenue $ 10,926 $ 2,097 $ 8,829 Research and development expense $ 116,744 $ (2,789 ) $ 119,533 Net loss $ (145,480 ) $ 4,886 $ (150,366 ) Net loss per share - basic and diluted: $ (2.73 ) $ 0.09 $ (2.82 ) Impact of Topic 606 adoption on condensed consolidated statement of operations and comprehensive loss for the nine months ended September 30, 2018 (in thousands, except per share data) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Collaboration revenue $ 33,971 $ 9,116 $ 24,855 Research and development expense $ 328,867 $ (4,589 ) $ 333,456 Net loss $ (406,602 ) $ 13,705 $ (420,307 ) Net loss per share - basic and diluted: $ (7.95 ) $ 0.27 $ (8.22 ) Impact of Topic 606 adoption on condensed consolidated statement of cash flows for the nine months ended September 30, 2018 (in thousands) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Net loss $ (406,602 ) $ 13,705 $ (420,307 ) Changes in deferred revenue $ (31,981 ) $ (13,705 ) $ (18,276 ) The most significant change above relates to the Company’s collaboration revenue, which to date has been exclusively generated from its collaboration arrangement with Celgene. Under ASC 605, the Company accounted for contract modifications to the Celgene collaboration as they occurred and the accounting for those changes was prospective in nature. Through the application of the practical expedient discussed above in connection with the adoption of Topic 606, the Company reflected the aggregate effect of all modifications to the Celgene collaboration when identifying the satisfied and unsatisfied performance obligations, determining the transaction price, and allocating the transaction price. As a result, although the performance obligations identified under Topic 606 were generally consistent with the units of account identified under ASC 605, the timing of the allocation of the transaction price to the identified performance obligations under Topic 606 differed from the allocations of consideration under ASC 605. Accordingly, the transaction price ultimately allocated to each performance obligation under Topic 606 differed from the amounts allocated under ASC 605. As a result of adopting Topic 606, the Company established a deferred revenue deferred tax asset, and an offsetting valuation allowance, of $7.9 million through its accumulated deficit given it is not more likely than not that the deferred tax asset will be realized due to historical and expected future losses, such that there was no tax impact on the Company’s condensed consolidated financial statements as a result of adopting Topic 606. ASU 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments (“Topic 230”) ASU 2016-18, Statement of Cash Flows: Restricted Cash In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash (“ASU 2016-18”) (in thousands) As of September 30, 2018 As of September 30, 2017 Cash and cash equivalents $ 952,137 $ 237,962 Restricted cash included in receivables and other current assets 100 — Restricted cash included in restricted cash and other non-current assets 13,763 13,762 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 966,000 $ 251,724 ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope Modification Accounting In May 2017, the FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope Modification Accounting The new standard was effective beginning January 1, 2018. The adoption of this standard did not have a material impact on the Company’s ASU 2018-03, Technical Corrections and Improvements to Financial Instruments Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Liabilities In February 2018, the FASB issued ASU 2018-03, Technical Corrections and Improvements to Financial Instruments Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Liabilities (“ASU 2018-03”). The new standard amends the standard ASU 2016-01, Financial Instruments Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities , which was issued by the FASB in January 2016 and previously adopted by the Company. This amendment simplifies the impairment assessment of equity investments without readily determinable fair values by requiring a qualitative assessment to identify impairment. In addition, it requires enhanced disclosures about investments. The Company adopted ASU 2018-03 effective July 1, 2018. The adoption of this standard did not have an impact on the Company’s financial position or results of operations upon adoption. ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In June 2018, the FASB issued ASU 2018-07. The new standard simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new standard will be effective beginning January 1, 2019 and early adoption is permitted. The Company early adopted ASU 2018-07 effective July 1, 2018 using a cumulative-effect adjustment as of the date of adoption. The adoption of this standard did not have a material impact on the Company’s financial position or results of operations upon adoption. Not yet adopted ASU 2016-02, Leases and ASU 2018-11, Leases, Targeting Improvements In February 2016, the FASB issued ASU 2016-02, Leases, (“ASU 2016-02”) , which 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 12 months or less, as part of which a lessee can make an accounting policy election not to recognize lease assets and lease liabilities. 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. ASU 2016-02 will be effective beginning January 1, 2019 requiring the use of a modified retrospective transition approach applied at the beginning of the earliest comparative period presented in the financial statements. In July 2018, the FASB issued ASU 2018-11, Leases, Targeting Improvements , (“ASU 2018-11”), which contains certain amendments to ASU 2016-02 intended to provide relief in implementing the new standard. ASU 2018-11 provides registrants with an option to not restate comparative periods presented in the financial statements. The Company intends to elect this new transition approach using a cumulative-effect adjustment on the effective date of the standard, for which comparative periods will be presented in accordance with the previous guidance in ASC 840, Leases . The Company is currently evaluating the potential impact ASU 2016-02 may have on its financial position, results of operations, and related footnotes. The Company expects it will elect to utilize the available package of practical expedients permitted under the transition guidance within the new standard, which does not require the reassessment of the following: i) whether existing or expired arrangements are or contain a lease, ii) the lease classification of existing or expired leases, and iii) whether previous initial direct costs would qualify for capitalization under the new lease standard. Additionally, the Company expects it will make an accounting policy election to keep leases with an initial term of 12 months or less off of its balance sheet. The Company’s assessment will include, but is not limited to, evaluating the impact that this standard has on the lease of its corporate headquarters at 60 Binney Street in Cambridge, Massachusetts, its laboratory space in Seattle, Washington, its office space in Zug, Switzerland, its equipment leases, and its embedded leases. ASU 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 2017-08, Receivables – Nonrefundable Fees and Other Costs In April 2017, the FASB issued ASU 2017-08, Receivables – Nonrefundable Fees and Other Costs (“Subtopic 310-20”) Subtopic 310-20 calls for a modified retrospective application under which . The new standard will be effective beginning January 1, 2019 and early adoption is permitted for public entities. financial position or results of operations upon adoption. ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income The new standard will be effective beginning January 1, 2019 and early adoption is permitted. The adoption of this standard is not expected to have a material impact on the Company’s financial position and results of operations ASU 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 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”) |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Marketable securities | 3. Marketable securities The following table summarizes the available-for-sale securities held at September 30, 2018 and December 31, 2017 (in thousands): Description Amortized cost Unrealized gains Unrealized losses Fair value September 30, 2018 U.S. government agency securities and treasuries $ 1,042,297 $ 1 $ (4,705 ) $ 1,037,593 Certificates of deposit 9,320 — — 9,320 Total $ 1,051,617 $ 1 $ (4,705 ) $ 1,046,913 December 31, 2017 U.S. government agency securities and treasuries $ 841,895 $ — $ (3,579 ) $ 838,316 Certificates of deposit 17,480 1 — 17,481 Total $ 859,375 $ 1 $ (3,579 ) $ 855,797 The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity. At September 30, 2018 and December 31, 2017, the balance in the Company’s accumulated other comprehensive loss was composed primarily of activity related to the Company’s available-for-sale marketable 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 September 30, 2018 and December 31, 2017 was $640.1 million and $704.1 million, respectively. As of September 30, 2018 and December 31, 2017, there were $392.5 million and $134.4 million in securities held by the Company in an unrealized loss position for more than twelve months, respectively. No available-for-sale securities held as of September 30, 2018 or December 31, 2017 had remaining maturities greater than three years. |
Fair value measurements
Fair value measurements | 9 Months Ended |
Sep. 30, 2018 | |
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 September 30, 2018 and December 31, 2017 (in thousands): Description Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) September 30, 2018 Assets: Cash and cash equivalents $ 952,137 $ 936,168 $ 15,969 $ — Marketable securities: U.S. government agency securities and treasuries 1,037,593 — 1,037,593 — Certificates of deposit 9,320 — 9,320 — Total assets $ 1,999,050 $ 936,168 $ 1,062,882 $ — Liabilities: Contingent consideration $ 3,074 $ — $ — $ 3,074 Total liabilities $ 3,074 $ — $ — $ 3,074 December 31, 2017 Assets: Cash and cash equivalents $ 758,505 $ 758,505 $ — $ — Marketable securities: U.S. government agency securities and treasuries 838,316 — 838,316 — Certificates of deposit 17,481 — 17,481 — Total assets $ 1,614,302 $ 758,505 $ 855,797 $ — Liabilities: Contingent consideration $ 2,231 $ — $ — $ 2,231 Total liabilities $ 2,231 $ — $ — $ 2,231 Cash, cash equivalents and marketable securities 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 September 30, 2018 and December 31, 2017, cash and cash equivalents comprises cash, money market accounts, and U.S. treasury 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. 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. 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 nine months ended September 30, 2018 Beginning balance $ 2,231 Additions — Changes in fair value 843 Payments — Ending balance $ 3,074 Please refer to Note 8, “Commitments and contingencies” |
Other investment and investment
Other investment and investment receivable | 9 Months Ended |
Sep. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Other investment and investment receivable | 5. Other investment and investment receivable On August 20, 2018, the Company entered into a license and collaboration agreement with Gritstone Oncology, Inc. (“Gritstone”) to utilize Gritstone’s proprietary technology platform to identify and validate tumor-specific targets and provide TCRs directed to selected targets for use in the Company’s gene therapy products. Pursuant to this agreement, the Company paid Gritstone a non-refundable, non-creditable upfront payment of $20.0 million, which is inclusive of Gritstone’s costs to perform activities allocated to it under the research plan. The Company may also make, depending upon the resulting product, future payments of up to $129.0 million per therapy product and $27.5 million per target product for development, regulatory, and commercial milestones as well as low single-digit tiered royalty payments based on annual net sales. The Company accounted for $14.5 million of the $20.0 million upfront payment as prepaid research and development costs, $3.2 million of which is reflected within prepaid expenses and $11.3 million within restricted cash and other non-current assets on the Company’s condensed consolidated balance sheet as of September 30, 2018. In future periods, the Company will recognize expense on a quarterly basis as a proportion of effort incurred by Gritstone as a percentage of total effort expected to be expended. The remaining $5.5 million of the upfront payment was expensed within research and development expense on the Company’s condensed consolidated statement of operations and comprehensive loss for the quarter ending September 30, 2018, as this payment represented an access fee for technology that has no clear alternate future use under ASC 730-10, Research and Development The Company simultaneously entered into a stock purchase agreement with Gritstone, pursuant to which the Company purchased $10.0 million of Series C preferred shares. The Company will account for this investment as a marketable security as the Company does not have the power to control or significantly influence Gritstone’s operations. As the Series C preferred shares did not have a readily determinable fair value as of September 30, 2018, the Company elected the measurement alternative under ASC 321, Investments – Equity Securities On September 27, 2018, Gritstone announced the pricing of its initial public offering (“IPO”). In connection with Gritstone’s IPO, the Company initiated the purchase of 0.7 million common shares for $10.0 million. The purchase closed on September 28, 2018. Upon the closing of the IPO on October 2, 2018, the Company received its common shares and its Series C preferred shares were converted into common shares. As this transaction had not closed as of September 30, 2018, both the investment in Series C preferred shares of $10.0 million and the additional $10.0 million common stock investment receivable were recorded at cost within other investment and investment receivable as of September 30, 2018. In future periods, following Gritstone’s IPO, the Company will re-measure its combined $20.0 million investment in common shares at fair value at each reporting period, with subsequent changes in fair value reflected in earnings. |
Property, plant and equipment,
Property, plant and equipment, net | 9 Months Ended |
Sep. 30, 2018 | |
Property Plant And Equipment [Abstract] | |
Property, plant and equipment, net | 6. Property, plant and equipment, net Property, plant and equipment, net, consists of the following (in thousands): As of As of September 30, 2018 December 31, 2017 Land $ 1,210 $ 1,210 Building 179,754 164,414 Computer equipment and software 6,790 5,134 Office equipment 5,371 4,478 Laboratory equipment 32,159 24,914 Leasehold improvements 115 116 Construction-in-progress 33,103 15,189 Total property, plant and equipment 258,502 215,455 Less accumulated depreciation and amortization (25,639 ) (15,849 ) Property, plant and equipment, net $ 232,863 $ 199,606 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 September 30, 2018 and December 31, 2017 includes $27.3 million and $12.9 million, respectively, related to the North Carolina manufacturing facility. During the three months ended September 30, 2018, the Company placed $12.2 million of the North Carolina manufacturing facility into service and began to depreciate the assets. 60 Binney Street lease As of September 30, 2018, total property, plant and equipment, gross, includes $167.6 million related to the Company’s headquarters at 60 Binney Street in Cambridge, Massachusetts, of which $156.0 million was incurred by the landlord. As of December 31, 2017, total property, plant and equipment, gross, includes $164.4 million related to the Company’s headquarters at 60 Binney Street in Cambridge, Massachusetts, of which $156.0 million was incurred by the landlord. Please refer to Note 8, "Commitments and contingencies" |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 9 Months Ended |
Sep. 30, 2018 | |
Payables And Accruals [Abstract] | |
Accrued expenses and other current liabilities | 7. Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following (in thousands): As of As of September 30, 2018 December 31, 2017 Accrued goods and services $ 62,466 $ 29,533 Employee compensation 21,139 19,657 Accrued professional fees 2,177 1,402 Financing lease obligation, current portion 1,318 1,051 Accrued license and milestone fees 608 4,584 Other 627 838 Total accrued expenses and other current liabilities $ 88,335 $ 57,065 Accrued goods and services primarily include clinical manufacturing costs, contract research organization costs, and costs incurred related to the Company’s collaboration partnerships. |
Commitments and contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and contingencies | 8. Commitments and contingencies Operating lease commitments On June 3, 2016, the Company entered into a manufacturing agreement for the future commercial production of the Company’s Lenti-D and LentiGlobin product candidates 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 was required to pay $12.5 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. The Company paid $5.0 million for the achievement of the first and second contractual milestones during 2016 and paid $5.5 million for the third and fourth contractual milestones achieved during 2017. In March 2018, $1.5 million of the possible $2.0 million related to the fifth contractual milestone was achieved and was paid in the second quarter of 2018. Given that construction was completed in March 2018, beginning in April 2018 the Company will pay $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 that this agreement contains an embedded lease as the suites are designated for the Company’s exclusive use during the term of the agreement. The Company concluded that it is not the deemed owner during construction nor is it a capital lease under ASC 840-10, Leases – Overall On November 18, 2016, the Company entered into an agreement for future clinical and commercial production of the Company’s LentiGlobin and Lenti-D gene therapy drug products with a contract manufacturing organization at an existing facility. The term of the agreement is five years with a three year renewal at the mutual option of each party. Under the agreement, the Company is required to pay an up-front fee of €3.0 million, €2.0 million of which was paid in the fourth quarter of 2016 and €1.0 million of which was paid in the third quarter of 2018, and annual maintenance and production fees of up to €9.8 million, depending on its production needs. The Company may terminate this agreement with twelve months’ notice and a one-time termination fee. The Company concluded that this agreement contains an embedded lease as the clean rooms are designated for the Company’s exclusive use during the term of the agreement and determined that it is not a capital lease under ASC 840-10, Leases – Overall non-cancellable 60 Binney Street Lease commitments 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”) for its corporate headquarters with a term through March 31, 2027. Although the Company does not legally own the premises, it is deemed to be the owner of the building for accounting purposes because the Company was involved 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 during the construction period. Accordingly, construction costs that were incurred by the landlord directly or indirectly through reimbursement to the Company as part of its tenant improvement allowance have been recorded as an asset in property, plant and equipment, net with a related financing obligation in accrued expenses and other current liabilities and f on the Company’s condensed 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. 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 building over a useful life of 40 years and incurred interest expense related to the financing obligation of $3.9 million and $11.6 million for the three and nine months ended September 30, 2018, respectively. The Company incurred interest expense related to the financing obligation of $4.1 million and $7.8 million for the three and nine months ended September 30, 2017, respectively. The Company currently maintains a $13.8 million letter of credit as required under the terms of the lease. 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. 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 not met at September 30, 2018 and December 31, 2017 or royalties on future sales of specified products. 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 due in the event of termination to be based on the timing of the termination and the terms of the agreement. In each of 2018 and 2019, the Company expects to make payments of approximately $4.0 million and $23.0 million, respectively, under an agreement with a contract manufacturer. |
Collaborative arrangements
Collaborative arrangements | 9 Months Ended |
Sep. 30, 2018 | |
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 arrangement with Celgene Corporation (“Celgene”), which was originally entered into in March 2013 and was subsequently amended in June 2015, as further described below. During the three months ended September 30, 2018, the Company entered into a collaboration agreement with Regeneron Pharmaceuticals, Inc. (“Regeneron”), as further described below. Celgene Celgene Original Collaboration Agreement On March 19, 2013, the Company entered into a Master Celgene 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 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 is responsible for conducting discovery, research and development activities through completion of Phase I clinical studies during the initial term of the Celgene Collaboration Agreement, or three years. The collaboration was governed by a joint steering committee (“JSC”) formed by an equal number of representatives from the Company and Celgene. The JSC, among other activities, reviewed the collaboration program, reviewed and evaluated product candidates and approved regulatory plans. In addition to the JSC, the Celgene Collaboration Agreement provided that the Company and Celgene each appoint representatives to a patent committee, which was 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 exclusively to 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 upfront, one-time, non-refundable, non-creditable payment of $25.0 million. The collaboration continued to be 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 I 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 I clinical study for such product candidate (the “Option Period”), the Company 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 bb2121 License Agreement On February 10, 2016, Celgene exercised its option to obtain an exclusive worldwide license to develop and commercialize bb2121, the first product candidate under the Amended Celgene Collaboration Agreement, pursuant to an executed license agreement (“bb2121 License Agreement”) entered into by the parties on February 16, 2016 and paid the Company an option fee of $10.0 million. Pursuant to the bb2121 License Agreement, Celgene was responsible for development and related funding of bb2121 after the substantial completion of the on-going Phase I clinical trial. The Company was responsible for the manufacture of vector and associated payload throughout development and, upon Celgene’s request, commercialization, which is fully reimbursed by Celgene, and Celgene was responsible for the manufacture of drug product throughout development and commercialization. Celgene bb2121 Co-Development, Co-Promote and Profit Share Agreement On March 28, 2018, the Company elected to co-develop and co-promote bb2121 within the U.S. pursuant to the execution of the Amended and Restated Co-Development, Co-Promote and Profit Share Agreement (“bb2121 CCPS”). The responsibilities of the parties remain unchanged from those under the bb2121 License Agreement, however, the Company will share equally in all profits and losses relating to developing, commercializing and manufacturing bb2121 within the U.S. and has the right to participate in the development and promotion of bb2121 in the U.S. Under the bb2121 CCPS, the Company may receive up to $70.0 million in development milestone payments for the first indication to be addressed by the bb2121 product candidate, with the ability to obtain additional milestone payments for a second indication and modified licensed products. In addition, to the extent bb2121 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 I clinical trial. The Company is responsible for the manufacture of vector and associated payload throughout development and, upon Celgene’s request, commercialization, which is fully reimbursed by Celgene, and Celgene is responsible for the manufacture of drug product throughout development and commercialization. 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 ongoing Phase I 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. 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 – bb2121 The Company has elected to use a practical expedient within Topic 606 that allow entities to reflect the aggregate effect of all contract modifications when identifying the satisfied and unsatisfied performance obligations for contracts that were modified prior to Topic 606 adoption. Celgene’s option to in-license the first product candidate, bb2121, under the arrangement was considered a material right at the time the Amended Celgene Collaboration Agreement was executed in June 2015 given the product candidate had been formally nominated by the JSC and that substantially all investigational new drug application, or IND, enabling activities had been completed by that time. Therefore, Celgene’s February 2016 exercise of its option that was considered a material right to obtain an exclusive worldwide license to develop and commercialize the first product candidate, bb2121, under the collaboration represented a contract modification. As a result, the Celgene Collaboration Agreement, Amended Celgene Collaboration Agreement, and bb2121 CCPS are combined for accounting purposes and treated as a single arrangement. As of February 2016, Celgene’s option to license an additional product candidate under the collaboration did not represent a material right. Therefore, the license to the Company’s second product candidate, bb21217, which was executed in September 2017, is accounted for as a separate contract. Refer below for discussion of the bb21217 accounting analysis. 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 the first product candidate, bb2121, and (iii) manufacture of vectors and associated payload for incorporation into bb2121 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 and thus such services are considered to be a separate performance obligation. The Company concluded that the license to bb2121 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. As of September 30, 2018, the total transaction price of $185.5 million comprises the up-front non-refundable fees of $100.0 million, the option fee of $10.0 million, and the estimated variable consideration of $75.5 million related 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 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. None of the clinical or regulatory milestones have been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including the fact that achievement of the milestones is outside the control of the Company and contingent upon the future success of its clinical trials, the licensee’s efforts, and 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 will re-evaluate the transaction price, including its estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur. bb2121 research and development services The Company allocated $36.6 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 I 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 has fully satisfied this performance obligation during the second quarter of 2018, any future changes to the total transaction price allocated to the performance obligations under the arrangement may impact the revenue recognized for this performance obligation in the period of change. The Company recognized revenue related to bb2121 research and development services of $0.6 million and $3.7 million for the three and nine months ended September 30, 2018, respectively. The Company recognized revenue related to bb2121 research and development services of $1.6 million and $4.7 million for the three and nine months ended September 30, 2017, respectively. bb2121 license and manufacturing services The Company allocated $148.9 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 bb2121. 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 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 bb2121, including expected demand from Celgene, and the costs associated with the manufacture of vectors and associated payload for incorporation into bb2121. 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 bb2121 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. In developing the SSP for the combined performance obligation, management assumed that the Company would exercise its option to co-develop and co-promote bb2121, and therefore will recognize revenue related to 67.5% of worldwide development costs incurred, which represents the percentage the Company is contractually entitled to bill Celgene under the cost share provisions of the co-development and co-promotion agreement, upon its execution. The Company exercised its option to co-develop and co-promote bb2121 in March 2018. The period of performance and pattern of revenue recognition remained unchanged upon its execution and will be revisited as the development plan changes or if other events occur. As noted above, the calculation of revenue or research and development expense to be recognized for the Company’s U.S. manufacturing services 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. For the three months ended March 31, 2018, the Company recognized revenue of $3.9 million (representative of gross revenue of $11.8 million offset by approximately $7.9 million of cost reimbursement to Celgene) related to the combined unit of accounting for its license and vector manufacturing of bb2121 in the U.S. For the three months ended June 30, 2018, the portion of Celgene’s U.S. development costs that the Company is responsible for were in excess of the Company’s corresponding U.S. development costs, and, as such, the Company recognized research and development expense of $3.3 million (which is representative of gross revenue of $8.5 million offset by approximately $11.8 million of cost reimbursement to Celgene) related to the combined unit of accounting. For the three months ended September 30, 2018, the portion of Celgene’s U.S. development costs that the Company is responsible for are in excess of the Company’s corresponding U.S. development costs, and, as such, the Company recorded research and development expense of $5.3 million (which is representative of gross revenue of $11.2 million offset by approximately $16.6 million of cost reimbursement to Celgene) related to the combined unit of accounting. Revenue related to the combined unit of accounting for its rest of world license and vector manufacturing services is accounted for in accordance with Topic 606 and is recognized as collaboration revenue. The Company recognized $9.6 million and $24.3 million of revenue related to the combined unit of accounting for its rest of world license and vector manufacturing services for the three and nine months ended September 30, 2018, respectively. The Company recognized $7.7 million and $18.6 million of revenue related to the combined unit of accounting of accounting for its license and vector manufacturing services for the three and nine months ended September 30, 2017, respectively, in accordance with ASC 605. As of September 30, 2018, the aggregate amount of the transaction price allocated to the combined performance obligation, which consists of the bb2121 license and manufacturing services, that is unsatisfied, or partially unsatisfied, is $63.1 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. The Company had $32.1 million remaining deferred revenue as of September 30, 2018 associated with the combined performance obligation consisting of the bb2121 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 and thus is considered to be a performance obligation. Similar to bb2121, the Company concluded that the license to bb21217 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. As of September 30, 2018, the total transaction price of $41.7 million comprises the option fee of $15.0 million and the estimated variable consideration of $26.7 million related 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. None of the clinical or regulatory milestones have been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including the fact that achievement of the milestones is outside the control of the Company and contingent upon the future success of its clinical trials, the licensee’s efforts, and 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 will re-evaluate the transaction price, including is estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur. 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 I 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 Company recognized revenue related to bb21217 research and development services for Celgene of $0.7 million and $2.2 million for the three and nine months ended September 30, 2018, respectively. During the three and nine months ended September 30, 2017, the Company did not recognize any revenue under the bb21217 License Agreement. As of September 30, 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 $2.9 million, 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 September 30, 2018, the manufacturing services for bb21217 had not yet commenced. Therefore, no revenue has been recognized for the combined unit of accounting for the three and nine months ended September 30, 2018 and 2017. 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 remaining deferred revenue as of September 30, 2018 associated with the combined performance obligation consisting of the bb21217 license and manufacturing services. Contract assets and liabilities 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 nine months ended September 30, 2018: (in thousands) Balance at beginning of period under Topic 606 Additions Deductions Balance at end of period under Topic 606 Receivables $ 4,635 $ 1,641 (6,276 ) $ — Contract liabilities: Payable included in accrued expenses — $ 8,031 $ (2,824 ) $ 5,207 Deferred revenue $ 76,812 — $ (31,981 ) $ 44,831 The change in the receivables balance for the nine months ended September 30, 2018 is primarily driven by cash collected from Celgene for the amounts owed to the Company for the satisfaction of vector manufacturing services performed under the collaboration to date. As of September 30, 2018, the Company does not have a receivable given that any amounts owed to the Company through September 30, 2018 were collected in the period and Celgene’s U.S. development costs incurred in the second and third quarters of 2018 for which the Company is responsible are in excess of the Company’s U.S. development costs for which Celgene is responsible. The decrease in deferred revenue during the nine months ended September 30, 2018 is primarily driven by revenue recognized for the combined performance obligation consisting of the bb2121 license and manufacturing services. During the nine months ended September 30, 2018, $32.0 million of the deferred revenue balance at the beginning of the period was recognized as gross revenues. 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. Where Regeneron does not exercise its option, or does not have an option to a target, the target would also become a licensed 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 420,000 of the Company’s common shares and joint research activities during the five year research collaboration term. The Company determined the total transaction price to |
License and royalty revenue
License and royalty revenue | 9 Months Ended |
Sep. 30, 2018 | |
License And Royalty Revenue [Abstract] | |
License and royalty revenue | 10. License and royalty revenue Novartis Pharma AG On April 26, 2017, the Company entered into a worldwide license agreement with Novartis Pharma AG (“Novartis”). Under the terms of the agreement, Novartis non-exclusively licensed certain patent rights related to lentiviral vector technology to develop and commercialize CAR T cell therapies for oncology, including Kymriah (formerly known as CTL019), Novartis’s anti-CD19 CAR T therapy. At contract inception, financial terms of the agreement included a $7.5 million payment upon execution, $7.5 million of potential future milestone payments associated with regulatory approvals, and $1.1 million of payments for each subsequently licensed product, as well as low single digit royalty payments on net sales of covered products. In August 2017, Novartis received FDA approval for Kymriah and paid the Company $2.5 million as a result of the achievement of a related milestone. Given this arrangement is within the scope of Topic 606, the Company assessed this arrangement in accordance with Topic 606 and concluded that at the date of contract inception, only one performance obligation, consisting of the license which was satisfied at contract inception, was identified. Accordingly, the nonrefundable license fee of $7.5 million was recognized as revenue upon contract execution in the second quarter of 2017 and the $2.5 million regulatory milestone was recognized as revenue upon milestone achievement, also in the second quarter of 2017, given there were no other unsatisfied performance obligations in the arrangement. This accounting conclusion was unchanged from its historical treatment under ASC 605. Because the single performance obligation was previously satisfied, all regulatory milestones will be recognized as revenue in full in the period in which the associated milestone is achieved. Regulatory approvals are not within the Company’s control or the licensee’s control and are generally not considered probable of being achieved until those approvals are received. As such, these milestones are constrained and excluded from the transaction price until such time as regulatory approvals are received. The Company began recognizing royalty revenue from sales of Kymriah in the fourth quarter of 2017. As the license was deemed to be the predominant item to which the royalties relate, the Company recognizes royalties from the sales of Kymriah when the related sales occur. For the three and nine months ended September 30, 2018, the Company recognized royalty revenue of $0.6 million and $1.4 million, respectively. The Company did not recognize royalty revenue in the comparative periods in the prior year given that Kymriah was first approved for commercial sale in the second half of 2017. The associated cost of license and royalty revenue for the three and nine months ended September 30, 2018 was less than $0.1 million in both periods. For the three and nine months ended September 30, 2017, the cost of license and royalty revenue was $1.1 million and $1.4 million, respectively. Orchard Therapeutics Limited (formerly GlaxoSmithKline Intellectual Property Development Limited) On April 28, 2017, the Company entered into a worldwide license agreement with GlaxoSmithKline Intellectual Property Development Limited (“GSK”). Under the terms of the agreement, GSK non-exclusively licensed certain patent rights related to lentiviral vector technology to develop and commercialize gene therapies for Wiscott-Aldrich syndrome and metachromatic leukodystrophy, two rare genetic diseases. Financial terms of the agreement include a nonrefundable upfront payment of $3.0 million as well as $1.3 million of potential milestone payments for each marketing authorization for each indication in any country as well as low single digit royalties on net sales of covered products. This license agreement was assigned by GSK to Orchard Therapeutics Limited, effective as of April 11, 2018. Given this arrangement is within the scope of Topic 606, the Company assessed this arrangement in accordance with Topic 606 and concluded that at the date of contract inception, only one performance obligation, consisting of the license which was satisfied at contract inception, was identified. Accordingly, the entire nonrefundable license fee of $3.0 million was recognized as revenue upon contract execution in the second quarter of 2017 given there were no other unsatisfied performance obligations in the arrangement. This accounting conclusion was unchanged from its historical treatment under ASC 605. Because the single performance obligation was previously satisfied, all regulatory milestones will be recognized as revenue in full in the period in which the associated milestone is achieved. Regulatory approvals are not within the Company’s control or the licensee’s control and are generally not considered probable of being achieved until those approvals are received. As such, these milestones are constrained and excluded from the transaction price until such time as regulatory approvals are received. During the three and nine months ended September 30, 2017, the Company recognized revenue of $3.0 million upon delivery of the license, as there were no other undelivered elements in the arrangements. There was no revenue recognized under this arrangement in the three and nine months ended September 30, 2018. For the three and nine months ended September 30, 2017 the cost of license and royalty revenue was $0.1 million. Given there was no revenue recognized under this arrangement in the three and nine months ended September 30, 2018, there was no associated cost of license and royalty revenue. |
Equity
Equity | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Equity | 11. Equity On December 15, 2017, the Company sold 3.2 million shares of common stock through an underwritten public offering at a price of $185.00 per share for aggregate net proceeds of $569.8 million. In January 2018, the Company sold an additional 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 | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based compensation | 12. Stock-based compensation In January 2018 and 2017, the number of shares of common stock available for issuance under the 2013 Stock Option and Incentive Plan (“2013 Plan”) was increased by approximately 2.0 million and 1.6 million shares, respectively, as a result of the automatic increase provision of the 2013 Plan. As of September 30, 2018, the total number of shares of common stock available for issuance under the 2013 Plan was approximately 1.6 million. Stock-based compensation expense The Company recognized stock-based compensation expense totaling $29.8 million and $80.8 million for the three and nine months ended September 30, 2018, respectively. The Company recognized stock-based compensation expense totaling $14.0 million and $39.0 million for the three and nine months ended September 30, 2017, respectively. Stock-based compensation expense by award type included within the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): For the For the three months ended September 30, nine months ended September 30, 2018 2017 2018 2017 Stock options $ 22,663 $ 10,786 $ 60,890 $ 30,892 Restricted stock units 6,918 3,067 19,413 7,659 Employee stock purchase plan 216 130 546 402 $ 29,797 $ 13,983 $ 80,849 $ 38,953 Stock-based compensation expense by classification included within the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): For the For the three months ended September 30, nine months ended September 30, 2018 2017 2018 2017 Research and development $ 14,445 $ 7,049 $ 40,265 $ 19,500 General and administrative 15,352 6,934 40,584 19,453 $ 29,797 $ 13,983 $ 80,849 $ 38,953 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 September 30, 2018 and none of which vested during the three or nine months ended September 30, 2018. Vesting of these awards is contingent on the occurrence of a certain regulatory milestone event and fulfillment of any remaining service condition. As a result, the related compensation cost will be first recognized as expense if and when achievement of the regulatory milestone is considered probable. These awards were modified in the second quarter of 2018 as a result of the adoption of a broad-based employee plan. The Company did not recognize any expense during the three or nine months ended September 30, 2018 related to these awards and may recognize up to $38.8 million in stock-based compensation expense related to these awards upon achievement of the performance condition and subject to the service based condition. As of September 30, 2018, the Company had $286.4 million of unrecognized stock-based compensation expense related to unvested stock options, restricted stock units and the employee stock purchase plan, which is expected to be recognized over a weighted-average period of 3.0 years, exclusive of any potential future stock-based compensation expense that may be recognized on any of the Company’s outstanding performance-based awards for which the performance conditions were deemed not probable of achievement as of September 30, 2018. 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, 2017 3,755 $ 67.91 Granted 1,416 $ 193.00 Exercised (535 ) $ 52.87 Canceled or forfeited (97 ) $ 134.63 Outstanding at September 30, 2018 4,539 $ 107.28 Exercisable at September 30, 2018 2,035 $ 60.91 Vested and expected to vest at September 30, 2018 4,507 $ 107.32 During the nine months ended September 30, 2018, 0.5 million shares of common stock were exercised, resulting in total proceeds to the Company of $28.3 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, 2017 477 $ 80.72 Granted 626 $ 197.79 Vested (132 ) $ 81.80 Forfeited (37 ) $ 159.04 Unvested balance at September 30, 2018 934 $ 155.94 Refer above for discussion of the performance-based restricted stock units granted in February 2018, which are included in the table above. 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 238,000 shares 2017, 16,026 and shares |
Income taxes
Income taxes | 9 Months Ended |
Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income taxes | 13. 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. On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (“SAB 118”), which allows the recording of provisional amounts during a measurement period not to extend beyond one year of the enactment date. In accordance with SAB 118, the Company determined a provisional amount for the impact on its prior year deferred tax assets and valuation allowance in its prior year financial statements. The Company has not updated the provisional amounts and expects to complete the final assessment of the impact within the measurement period. |
Net loss per share
Net loss per share | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net loss per share | 14. Net loss per share The following common stock equivalents were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect (in thousands): For the three and nine months ended September 30, 2018 2017 Outstanding stock options 4,539 4,016 Restricted stock units 934 456 ESPP shares 10 10 5,483 4,482 |
Subsequent events
Subsequent events | 9 Months Ended |
Sep. 30, 2018 | |
Subsequent Events [Abstract] | |
Subsequent events | 15. Subsequent events On October 11, 2018, the Company entered into a manufacturing agreement for the production of vector for the Company’s BCMA product candidate with a contract manufacturing organization that generally provides for termination on notice, with the exact amounts due in the event of termination to be based on the timing of the termination and the terms of the agreement. Under this agreement, the Company will be required to pay a minimum of approximately $197.7 million. |
Basis of presentation, princi_2
Basis of presentation, principles of consolidation and significant accounting policies (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
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 September 30, 2018 and 2017. 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 financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2017, 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, 2018. 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. |
Principles of consolidation | Principles of consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to GAAP. The Company views its operations and manages its business in one operating segment. All material long-lived assets of the Company reside in the United States. |
Significant accounting policies | Significant accounting policies The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2018 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s 2017 Annual Report on Form 10-K, except as noted below with respect to the Company’s revenue recognition, collaboration revenue and license and royalty revenue accounting policies and as noted within the “Recent accounting pronouncements – Recently adopted” |
Revenue Recognition | Revenue recognition Effective January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue generating arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied, either at a point in time or over time, and if over time recognition is based on the use of an output or input method. Collaboration revenue To date, the Company’s collaboration revenue has been exclusively generated from its collaboration arrangement with Celgene, which was originally entered into in March 2013 and was subsequently amended in June 2015, as further described in Note 9, “ Collaborative arrangements The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements License and royalty revenue The Company enters into out-licensing agreements that are within the scope of Topic 606. The Company does not have any material license arrangements that contain more than one performance obligation. The terms of such out-license agreements include the license of functional intellectual property, given the functionality of the intellectual property is not expected to change substantially as a result of the licensor’s ongoing activities, and typically include payment of one or more of the following: non-refundable up-front license fees; development and regulatory milestone payments and milestone payments based on the level of sales; and royalties on net sales of licensed products. Nonrefundable up-front license fees are recognized as revenue at a point in time when the licensed intellectual property is made available for the customer’s use and benefit, which is generally at the inception of the arrangement. Milestone fees, which are a type of variable consideration, are recognized as revenue to the extent that it is probable that a significant reversal will not occur. For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied. For a complete discussion of accounting for collaboration and other revenue-generating arrangements, see Note 9, “Collaborative arrangements” “License and royalty revenue” Recent accounting pronouncements - Recently adopted |
Share-based Compensation | Share-based compensation The Company’s share-based compensation programs grant awards that have included stock options, restricted stock units, restricted stock awards, and shares issued under its employee stock purchase plan. Grants are awarded to employees, including directors, and non-employees. As noted in the Company’s 2017 Annual Report on Form 10-K, the Company historically applied the guidance in FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees, to account for its awards to non-employees pursuant to which the measurement date for non-employee awards was generally the date the services are completed, resulting in financial reporting period adjustments to stock-based compensation during the vesting terms for changes in the fair value of the awards. As discussed below under “Recently Adopted Accounting Pronouncements”, in the third quarter of 2018 the Company adopted ASU No. 2018-07, “ Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting |
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. 2014 -09, In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers Revenue Recognition Revenue from Contracts with Customers • For contracts that were modified prior to Topic 606 adoption, the Company has not retrospectively accounted for each contract modification in accordance with the contract modification guidance. Instead, the Company reflected the aggregate effect of all modifications occurring prior to Topic 606 adoption when identifying the sa tisfied and unsatisfied performance obligations, determining the transaction price and allocating the transaction price. As a result of adopting Topic 606, the Company recorded a $29.4 million adjustment to the opening balance of accumulated deficit in the first quarter of 2018 primarily as a result of the accounting for the up-front consideration received in March 2013 in connection with the collaboration arrangement with Celgene under ASC 605-25 versus Topic 606. Refer below for a summary of t he amount by which each financial statement line item was affected by Impact of Topic 606 adoption on condensed consolidated balance sheet as of January 1, 2018 (in thousands) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Deferred revenue, current portion $ 45,344 $ 19,670 $ 25,674 Deferred revenue, net of current portion $ 31,468 $ 9,705 $ 21,763 Accumulated deficit $ (943,183 ) $ (29,375 ) $ (913,808 ) The amount by which each financial statement line item is affected in the current reporting period by Topic 606 as compared with the guidance that was in effect prior to adoption is disclosed below. Impact of Topic 606 adoption on condensed consolidated balance sheet as of September 30, 2018 (in thousands) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Deferred revenue, current portion $ 22,575 $ 9,596 $ 12,979 Deferred revenue, net of current portion $ 22,256 $ 6,074 $ 16,182 Accumulated deficit $ (1,349,785 ) $ 15,670 $ (1,365,455 ) Impact of Topic 606 adoption on condensed consolidated statement of operations and comprehensive loss for the three months ended September 30, 2018 (in thousands, except per share data) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Collaboration revenue $ 10,926 $ 2,097 $ 8,829 Research and development expense $ 116,744 $ (2,789 ) $ 119,533 Net loss $ (145,480 ) $ 4,886 $ (150,366 ) Net loss per share - basic and diluted: $ (2.73 ) $ 0.09 $ (2.82 ) Impact of Topic 606 adoption on condensed consolidated statement of operations and comprehensive loss for the nine months ended September 30, 2018 (in thousands, except per share data) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Collaboration revenue $ 33,971 $ 9,116 $ 24,855 Research and development expense $ 328,867 $ (4,589 ) $ 333,456 Net loss $ (406,602 ) $ 13,705 $ (420,307 ) Net loss per share - basic and diluted: $ (7.95 ) $ 0.27 $ (8.22 ) Impact of Topic 606 adoption on condensed consolidated statement of cash flows for the nine months ended September 30, 2018 (in thousands) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Net loss $ (406,602 ) $ 13,705 $ (420,307 ) Changes in deferred revenue $ (31,981 ) $ (13,705 ) $ (18,276 ) The most significant change above relates to the Company’s collaboration revenue, which to date has been exclusively generated from its collaboration arrangement with Celgene. Under ASC 605, the Company accounted for contract modifications to the Celgene collaboration as they occurred and the accounting for those changes was prospective in nature. Through the application of the practical expedient discussed above in connection with the adoption of Topic 606, the Company reflected the aggregate effect of all modifications to the Celgene collaboration when identifying the satisfied and unsatisfied performance obligations, determining the transaction price, and allocating the transaction price. As a result, although the performance obligations identified under Topic 606 were generally consistent with the units of account identified under ASC 605, the timing of the allocation of the transaction price to the identified performance obligations under Topic 606 differed from the allocations of consideration under ASC 605. Accordingly, the transaction price ultimately allocated to each performance obligation under Topic 606 differed from the amounts allocated under ASC 605. As a result of adopting Topic 606, the Company established a deferred revenue deferred tax asset, and an offsetting valuation allowance, of $7.9 million through its accumulated deficit given it is not more likely than not that the deferred tax asset will be realized due to historical and expected future losses, such that there was no tax impact on the Company’s condensed consolidated financial statements as a result of adopting Topic 606. ASU 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments (“Topic 230”) ASU 2016-18, Statement of Cash Flows: Restricted Cash In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash (“ASU 2016-18”) (in thousands) As of September 30, 2018 As of September 30, 2017 Cash and cash equivalents $ 952,137 $ 237,962 Restricted cash included in receivables and other current assets 100 — Restricted cash included in restricted cash and other non-current assets 13,763 13,762 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 966,000 $ 251,724 ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope Modification Accounting In May 2017, the FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope Modification Accounting The new standard was effective beginning January 1, 2018. The adoption of this standard did not have a material impact on the Company’s ASU 2018-03, Technical Corrections and Improvements to Financial Instruments Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Liabilities In February 2018, the FASB issued ASU 2018-03, Technical Corrections and Improvements to Financial Instruments Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Liabilities (“ASU 2018-03”). The new standard amends the standard ASU 2016-01, Financial Instruments Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities , which was issued by the FASB in January 2016 and previously adopted by the Company. This amendment simplifies the impairment assessment of equity investments without readily determinable fair values by requiring a qualitative assessment to identify impairment. In addition, it requires enhanced disclosures about investments. The Company adopted ASU 2018-03 effective July 1, 2018. The adoption of this standard did not have an impact on the Company’s financial position or results of operations upon adoption. ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In June 2018, the FASB issued ASU 2018-07. The new standard simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new standard will be effective beginning January 1, 2019 and early adoption is permitted. The Company early adopted ASU 2018-07 effective July 1, 2018 using a cumulative-effect adjustment as of the date of adoption. The adoption of this standard did not have a material impact on the Company’s financial position or results of operations upon adoption. Not yet adopted ASU 2016-02, Leases and ASU 2018-11, Leases, Targeting Improvements In February 2016, the FASB issued ASU 2016-02, Leases, (“ASU 2016-02”) , which 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 12 months or less, as part of which a lessee can make an accounting policy election not to recognize lease assets and lease liabilities. 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. ASU 2016-02 will be effective beginning January 1, 2019 requiring the use of a modified retrospective transition approach applied at the beginning of the earliest comparative period presented in the financial statements. In July 2018, the FASB issued ASU 2018-11, Leases, Targeting Improvements , (“ASU 2018-11”), which contains certain amendments to ASU 2016-02 intended to provide relief in implementing the new standard. ASU 2018-11 provides registrants with an option to not restate comparative periods presented in the financial statements. The Company intends to elect this new transition approach using a cumulative-effect adjustment on the effective date of the standard, for which comparative periods will be presented in accordance with the previous guidance in ASC 840, Leases . The Company is currently evaluating the potential impact ASU 2016-02 may have on its financial position, results of operations, and related footnotes. The Company expects it will elect to utilize the available package of practical expedients permitted under the transition guidance within the new standard, which does not require the reassessment of the following: i) whether existing or expired arrangements are or contain a lease, ii) the lease classification of existing or expired leases, and iii) whether previous initial direct costs would qualify for capitalization under the new lease standard. Additionally, the Company expects it will make an accounting policy election to keep leases with an initial term of 12 months or less off of its balance sheet. The Company’s assessment will include, but is not limited to, evaluating the impact that this standard has on the lease of its corporate headquarters at 60 Binney Street in Cambridge, Massachusetts, its laboratory space in Seattle, Washington, its office space in Zug, Switzerland, its equipment leases, and its embedded leases. ASU 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 2017-08, Receivables – Nonrefundable Fees and Other Costs In April 2017, the FASB issued ASU 2017-08, Receivables – Nonrefundable Fees and Other Costs (“Subtopic 310-20”) Subtopic 310-20 calls for a modified retrospective application under which . The new standard will be effective beginning January 1, 2019 and early adoption is permitted for public entities. financial position or results of operations upon adoption. ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income The new standard will be effective beginning January 1, 2019 and early adoption is permitted. The adoption of this standard is not expected to have a material impact on the Company’s financial position and results of operations ASU 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 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”) |
Basis of presentation, princi_3
Basis of presentation, principles of consolidation and significant accounting policies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Statement of Reconciliation of Cash Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the statement of financial position that sum to the total of the same such amounts shown in the statement of cash flows: (in thousands) As of September 30, 2018 As of September 30, 2017 Cash and cash equivalents $ 952,137 $ 237,962 Restricted cash included in receivables and other current assets 100 — Restricted cash included in restricted cash and other non-current assets 13,763 13,762 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 966,000 $ 251,724 |
ASU 2014-09 [Member] | |
Summary of Impact of Topic 606 Adoption on Financial Statement | Refer below for a summary of t he amount by which each financial statement line item was affected by Impact of Topic 606 adoption on condensed consolidated balance sheet as of January 1, 2018 (in thousands) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Deferred revenue, current portion $ 45,344 $ 19,670 $ 25,674 Deferred revenue, net of current portion $ 31,468 $ 9,705 $ 21,763 Accumulated deficit $ (943,183 ) $ (29,375 ) $ (913,808 ) The amount by which each financial statement line item is affected in the current reporting period by Topic 606 as compared with the guidance that was in effect prior to adoption is disclosed below. Impact of Topic 606 adoption on condensed consolidated balance sheet as of September 30, 2018 (in thousands) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Deferred revenue, current portion $ 22,575 $ 9,596 $ 12,979 Deferred revenue, net of current portion $ 22,256 $ 6,074 $ 16,182 Accumulated deficit $ (1,349,785 ) $ 15,670 $ (1,365,455 ) Impact of Topic 606 adoption on condensed consolidated statement of operations and comprehensive loss for the three months ended September 30, 2018 (in thousands, except per share data) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Collaboration revenue $ 10,926 $ 2,097 $ 8,829 Research and development expense $ 116,744 $ (2,789 ) $ 119,533 Net loss $ (145,480 ) $ 4,886 $ (150,366 ) Net loss per share - basic and diluted: $ (2.73 ) $ 0.09 $ (2.82 ) Impact of Topic 606 adoption on condensed consolidated statement of operations and comprehensive loss for the nine months ended September 30, 2018 (in thousands, except per share data) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Collaboration revenue $ 33,971 $ 9,116 $ 24,855 Research and development expense $ 328,867 $ (4,589 ) $ 333,456 Net loss $ (406,602 ) $ 13,705 $ (420,307 ) Net loss per share - basic and diluted: $ (7.95 ) $ 0.27 $ (8.22 ) Impact of Topic 606 adoption on condensed consolidated statement of cash flows for the nine months ended September 30, 2018 (in thousands) As reported under Topic 606 Adjustments Balances without adoption of Topic 606 Net loss $ (406,602 ) $ 13,705 $ (420,307 ) Changes in deferred revenue $ (31,981 ) $ (13,705 ) $ (18,276 ) |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Available for Sale Securities Held | The following table summarizes the available-for-sale securities held at September 30, 2018 and December 31, 2017 (in thousands): Description Amortized cost Unrealized gains Unrealized losses Fair value September 30, 2018 U.S. government agency securities and treasuries $ 1,042,297 $ 1 $ (4,705 ) $ 1,037,593 Certificates of deposit 9,320 — — 9,320 Total $ 1,051,617 $ 1 $ (4,705 ) $ 1,046,913 December 31, 2017 U.S. government agency securities and treasuries $ 841,895 $ — $ (3,579 ) $ 838,316 Certificates of deposit 17,480 1 — 17,481 Total $ 859,375 $ 1 $ (3,579 ) $ 855,797 |
Fair value measurements (Tables
Fair value measurements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
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 September 30, 2018 and December 31, 2017 (in thousands): Description Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) September 30, 2018 Assets: Cash and cash equivalents $ 952,137 $ 936,168 $ 15,969 $ — Marketable securities: U.S. government agency securities and treasuries 1,037,593 — 1,037,593 — Certificates of deposit 9,320 — 9,320 — Total assets $ 1,999,050 $ 936,168 $ 1,062,882 $ — Liabilities: Contingent consideration $ 3,074 $ — $ — $ 3,074 Total liabilities $ 3,074 $ — $ — $ 3,074 December 31, 2017 Assets: Cash and cash equivalents $ 758,505 $ 758,505 $ — $ — Marketable securities: U.S. government agency securities and treasuries 838,316 — 838,316 — Certificates of deposit 17,481 — 17,481 — Total assets $ 1,614,302 $ 758,505 $ 855,797 $ — Liabilities: Contingent consideration $ 2,231 $ — $ — $ 2,231 Total liabilities $ 2,231 $ — $ — $ 2,231 |
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 nine months ended September 30, 2018 Beginning balance $ 2,231 Additions — Changes in fair value 843 Payments — Ending balance $ 3,074 |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
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 September 30, 2018 December 31, 2017 Land $ 1,210 $ 1,210 Building 179,754 164,414 Computer equipment and software 6,790 5,134 Office equipment 5,371 4,478 Laboratory equipment 32,159 24,914 Leasehold improvements 115 116 Construction-in-progress 33,103 15,189 Total property, plant and equipment 258,502 215,455 Less accumulated depreciation and amortization (25,639 ) (15,849 ) Property, plant and equipment, net $ 232,863 $ 199,606 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
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 September 30, 2018 December 31, 2017 Accrued goods and services $ 62,466 $ 29,533 Employee compensation 21,139 19,657 Accrued professional fees 2,177 1,402 Financing lease obligation, current portion 1,318 1,051 Accrued license and milestone fees 608 4,584 Other 627 838 Total accrued expenses and other current liabilities $ 88,335 $ 57,065 |
Collaborative arrangements (Tab
Collaborative arrangements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Celgene Corporation [Member] | |
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 nine months ended September 30, 2018: (in thousands) Balance at beginning of period under Topic 606 Additions Deductions Balance at end of period under Topic 606 Receivables $ 4,635 $ 1,641 (6,276 ) $ — Contract liabilities: Payable included in accrued expenses — $ 8,031 $ (2,824 ) $ 5,207 Deferred revenue $ 76,812 — $ (31,981 ) $ 44,831 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
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 (in thousands): For the For the three months ended September 30, nine months ended September 30, 2018 2017 2018 2017 Stock options $ 22,663 $ 10,786 $ 60,890 $ 30,892 Restricted stock units 6,918 3,067 19,413 7,659 Employee stock purchase plan 216 130 546 402 $ 29,797 $ 13,983 $ 80,849 $ 38,953 |
Schedule of Stock-Based Compensation Expense by Classification | Stock-based compensation expense by classification included within the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): For the For the three months ended September 30, nine months ended September 30, 2018 2017 2018 2017 Research and development $ 14,445 $ 7,049 $ 40,265 $ 19,500 General and administrative 15,352 6,934 40,584 19,453 $ 29,797 $ 13,983 $ 80,849 $ 38,953 |
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, 2017 3,755 $ 67.91 Granted 1,416 $ 193.00 Exercised (535 ) $ 52.87 Canceled or forfeited (97 ) $ 134.63 Outstanding at September 30, 2018 4,539 $ 107.28 Exercisable at September 30, 2018 2,035 $ 60.91 Vested and expected to vest at September 30, 2018 4,507 $ 107.32 |
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, 2017 477 $ 80.72 Granted 626 $ 197.79 Vested (132 ) $ 81.80 Forfeited (37 ) $ 159.04 Unvested balance at September 30, 2018 934 $ 155.94 |
Net loss per share (Tables)
Net loss per share (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share | The following common stock equivalents were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect (in thousands): For the three and nine months ended September 30, 2018 2017 Outstanding stock options 4,539 4,016 Restricted stock units 934 456 ESPP shares 10 10 5,483 4,482 |
Description of the business - A
Description of the business - Additional Information (Detail) $ in Billions | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Date of incorporation | Apr. 16, 1992 |
Cash, cash equivalents and marketable securities | $ 2 |
Basis of presentation, princi_4
Basis of presentation, principles of consolidation and significant accounting policies - Additional Information (Detail) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2018USD ($)Segment | Jan. 01, 2018USD ($) | Dec. 31, 2017USD ($) | |
Basis Of Presentation And Significant Accounting Policies [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Accumulated deficit | $ 1,349,785 | $ 943,183 | $ 913,808 |
Description of performance obligations | Under ASC 605, the Company accounted for contract modifications to the Celgene collaboration as they occurred and the accounting for those changes was prospective in nature. Through the application of the practical expedient discussed above in connection with the adoption of Topic 606, the Company reflected the aggregate effect of all modifications to the Celgene collaboration when identifying the satisfied and unsatisfied performance obligations, determining the transaction price, and allocating the transaction price. As a result, although the performance obligations identified under Topic 606 were generally consistent with the units of account identified under ASC 605, the timing of the allocation of the transaction price to the identified performance obligations under Topic 606 differed from the allocations of consideration under ASC 605. Accordingly, the transaction price ultimately allocated to each performance obligation under Topic 606 differed from the amounts allocated under ASC 605. | ||
Deferred tax assets, valuation allowance | $ 7,900 | ||
ASU 2014-09 [Member] | Adjustments [Member] | |||
Basis Of Presentation And Significant Accounting Policies [Line Items] | |||
Accumulated deficit | $ (15,670) | $ 29,375 |
Basis of presentation, princi_5
Basis of presentation, principles of consolidation and significant accounting policies - Impact of Topic 606 Adoption on Condensed Consolidated Balance Sheets (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Basis Of Presentation And Significant Accounting Policies [Line Items] | |||
Deferred revenue, current portion | $ 22,575 | $ 45,344 | $ 25,674 |
Deferred revenue, net of current portion | 22,256 | 31,468 | 21,763 |
Accumulated deficit | (1,349,785) | (943,183) | $ (913,808) |
ASU 2014-09 [Member] | Adjustments [Member] | |||
Basis Of Presentation And Significant Accounting Policies [Line Items] | |||
Deferred revenue, current portion | 9,596 | 19,670 | |
Deferred revenue, net of current portion | 6,074 | 9,705 | |
Accumulated deficit | 15,670 | (29,375) | |
ASU 2014-09 [Member] | Balances Without Adoption of Topic 606 [Member] | |||
Basis Of Presentation And Significant Accounting Policies [Line Items] | |||
Deferred revenue, current portion | 12,979 | 25,674 | |
Deferred revenue, net of current portion | 16,182 | 21,763 | |
Accumulated deficit | $ (1,365,455) | $ (913,808) |
Basis of presentation, princi_6
Basis of presentation, principles of consolidation and significant accounting policies - Impact of Topic 606 Adoption on Condensed Consolidated Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||
Revenue | $ 11,528 | $ 7,711 | $ 35,336 | $ 31,259 |
Research and development expense | 116,744 | 61,545 | 328,867 | 180,464 |
Net loss | $ (145,480) | $ (78,805) | $ (406,602) | $ (218,415) |
Net loss per share - basic and diluted: | $ (2.73) | $ (1.73) | $ (7.95) | $ (5.14) |
Collaboration [Member] | ||||
Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||
Revenue | $ 10,926 | $ 5,211 | $ 33,971 | $ 18,189 |
ASU 2014-09 [Member] | Adjustments [Member] | ||||
Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||
Research and development expense | (2,789) | (4,589) | ||
Net loss | $ 4,886 | $ 13,705 | ||
Net loss per share - basic and diluted: | $ 0.09 | $ 0.27 | ||
ASU 2014-09 [Member] | Balances Without Adoption of Topic 606 [Member] | ||||
Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||
Research and development expense | $ 119,533 | $ 333,456 | ||
Net loss | $ (150,366) | $ (420,307) | ||
Net loss per share - basic and diluted: | $ (2.82) | $ (8.22) | ||
ASU 2014-09 [Member] | Collaboration [Member] | Adjustments [Member] | ||||
Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||
Revenue | $ 2,097 | $ 9,116 | ||
ASU 2014-09 [Member] | Collaboration [Member] | Balances Without Adoption of Topic 606 [Member] | ||||
Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||
Revenue | $ 8,829 | $ 24,855 |
Basis of presentation, princi_7
Basis of presentation, principles of consolidation and significant accounting policies - Impact of Topic 606 Adoption on Condensed Consolidated Statement of Cash Flows (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||
Net loss | $ (145,480) | $ (78,805) | $ (406,602) | $ (218,415) |
Changes in deferred revenue | (31,981) | $ 3,084 | ||
ASU 2014-09 [Member] | Adjustments [Member] | ||||
Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||
Net loss | 4,886 | 13,705 | ||
Changes in deferred revenue | (13,705) | |||
ASU 2014-09 [Member] | Balances Without Adoption of Topic 606 [Member] | ||||
Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||
Net loss | $ (150,366) | (420,307) | ||
Changes in deferred revenue | $ (18,276) |
Basis of presentation, princi_8
Basis of presentation, principles of consolidation and significant accounting policies - Statement of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 952,137 | $ 758,505 | $ 237,962 | |
Restricted cash included in receivables and other current assets | 100 | |||
Restricted cash included in restricted cash and other non-current assets | 13,763 | 13,762 | ||
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ 966,000 | $ 772,268 | $ 251,724 | $ 293,277 |
Marketable securities - Summary
Marketable securities - Summary of Available for Sale Securities Held (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized cost | $ 1,051,617 | $ 859,375 |
Unrealized gains | 1 | 1 |
Unrealized losses | (4,705) | (3,579) |
Fair value | 1,046,913 | 855,797 |
U.S. Government Agency Securities and Treasuries [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized cost | 1,042,297 | 841,895 |
Unrealized gains | 1 | |
Unrealized losses | (4,705) | (3,579) |
Fair value | 1,037,593 | 838,316 |
Certificates of Deposit [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized cost | 9,320 | 17,480 |
Unrealized gains | 1 | |
Fair value | $ 9,320 | $ 17,481 |
Marketable securities - Additio
Marketable securities - Additional Information (Detail) - USD ($) | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Investments Debt And Equity Securities [Abstract] | |||
Realized gain (loss) on available-for-sale securities | $ 0 | $ 0 | |
Reclassification out of accumulated other comprehensive income (loss) | 0 | $ 0 | |
Unrealized Loss on Securities | 640,100,000 | $ 704,100,000 | |
Unrealized loss on securities, more than twelve months | 392,500,000 | 134,400,000 | |
Unrealized loss on securities for less than twelve months | 1,800,000 | 3,300,000 | |
Unrealized loss on securities for more than twelve months | 2,900,000 | 300,000 | |
Investments with other-than-temporary impairment | $ 0 | $ 0 |
Fair value measurements - Recor
Fair value measurements - Recorded Amount of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Liabilities: | ||
Contingent consideration | $ 3,074 | $ 2,231 |
Fair Value, Measurements, Recurring [Member] | ||
Liabilities: | ||
Contingent consideration | 3,074 | 2,231 |
Total liabilities | 3,074 | 2,231 |
Assets: | ||
Cash and cash equivalents | 952,137 | 758,505 |
Total assets | 1,999,050 | 1,614,302 |
Fair Value, Measurements, Recurring [Member] | U.S. Government Agency Securities and Treasuries [Member] | ||
Assets: | ||
Marketable securities | 1,037,593 | 838,316 |
Fair Value, Measurements, Recurring [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Marketable securities | 9,320 | 17,481 |
Fair Value, Measurements, Recurring [Member] | Quoted prices in active markets (Level 1) [Member] | ||
Assets: | ||
Cash and cash equivalents | 936,168 | 758,505 |
Total assets | 936,168 | 758,505 |
Fair Value, Measurements, Recurring [Member] | Significant other observable inputs (Level 2) [Member] | ||
Assets: | ||
Cash and cash equivalents | 15,969 | |
Total assets | 1,062,882 | 855,797 |
Fair Value, Measurements, Recurring [Member] | Significant other observable inputs (Level 2) [Member] | U.S. Government Agency Securities and Treasuries [Member] | ||
Assets: | ||
Marketable securities | 1,037,593 | 838,316 |
Fair Value, Measurements, Recurring [Member] | Significant other observable inputs (Level 2) [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Marketable securities | 9,320 | 17,481 |
Fair Value, Measurements, Recurring [Member] | Significant unobservable inputs (Level 3) [Member] | ||
Liabilities: | ||
Contingent consideration | 3,074 | 2,231 |
Total liabilities | $ 3,074 | $ 2,231 |
Fair value measurements - Addit
Fair value measurements - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Cash equivalents maturities | 90 days or less |
Minimum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Milestone achievement period | 2,021 |
Milestone discount rates | 16.20% |
Maximum [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Milestone achievement period | 2,028 |
Milestone discount rates | 17.00% |
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 | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Beginning balance | $ 2,231 |
Changes in fair value | 843 |
Ending balance | $ 3,074 |
Other investments and investmen
Other investments and investment receivable - Additional Information (Detail) - USD ($) shares in Millions | Sep. 28, 2018 | Aug. 20, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 |
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Research and development expense | $ 116,744,000 | $ 61,545,000 | $ 328,867,000 | $ 180,464,000 | ||
Other investment and investment receivable | 20,017,000 | 20,017,000 | ||||
Gritstone Oncology, Inc. [Member] | ||||||
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Other investment and investment receivable | 20,000,000 | 20,000,000 | ||||
Gritstone Oncology, Inc. [Member] | Series C Preferred Shares [Member] | ||||||
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Payments to purchase investments | $ 10,000,000 | |||||
Gritstone Oncology, Inc. [Member] | Common Shares [Member] | Initial Public Offering [Member] | ||||||
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Payments to purchase investments | $ 10,000,000 | |||||
Number of securities purchased | 0.7 | |||||
Gritstone Oncology, Inc. [Member] | Other Investment and Investment Receivable [Member] | Series C Preferred Shares [Member] | ||||||
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Investment recorded at cost | 10,000,000 | 10,000,000 | ||||
Gritstone Oncology, Inc. [Member] | Other Investment and Investment Receivable [Member] | Common Shares [Member] | ||||||
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Investment recorded at cost | 10,000,000 | 10,000,000 | ||||
License and Collaboration Agreement [Member] | Gritstone Oncology, Inc. [Member] | ||||||
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Upfront payment | 20,000,000 | |||||
Upfront future payment | 27,500,000 | |||||
Prepaid research and development costs | 14,500,000 | 14,500,000 | ||||
Research and development expense | 5,500,000 | |||||
License and Collaboration Agreement [Member] | Gritstone Oncology, Inc. [Member] | Prepaid Expenses [Member] | ||||||
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Prepaid research and development costs | 3,200,000 | 3,200,000 | ||||
License and Collaboration Agreement [Member] | Gritstone Oncology, Inc. [Member] | Restricted Cash and Other Non-current Assets [Member] | ||||||
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Prepaid research and development costs | $ 11,300,000 | $ 11,300,000 | ||||
License and Collaboration Agreement [Member] | Gritstone Oncology, Inc. [Member] | Maximum [Member] | Therapy Product [Member] | ||||||
Schedule Of Trading Securities And Other Trading Assets [Line Items] | ||||||
Upfront future payment | $ 129,000,000 |
Property, plant and equipment_3
Property, plant and equipment, net - Summary of Property, Plant and Equipment Net (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | $ 258,502 | $ 215,455 |
Less accumulated depreciation and amortization | (25,639) | (15,849) |
Property, plant and equipment, net | 232,863 | 199,606 |
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 | 179,754 | 164,414 |
Computer Equipment and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 6,790 | 5,134 |
Office Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 5,371 | 4,478 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 32,159 | 24,914 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | 115 | 116 |
Construction in Progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Total property, plant and equipment | $ 33,103 | $ 15,189 |
Property, plant and equipment_4
Property, plant and equipment, net - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 258,502 | $ 215,455 |
Construction In Progress North Carolina Manufacturing Facility [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 27,300 | 12,900 |
60 Binney Street [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 167,600 | 164,400 |
Construction cost incurred by landlord | 156,000 | $ 156,000 |
North Carolina Manufacturing Facility [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 12,200 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Accrued goods and services | $ 62,466 | $ 29,533 |
Employee compensation | 21,139 | 19,657 |
Accrued professional fees | 2,177 | 1,402 |
Financing lease obligation, current portion | 1,318 | 1,051 |
Accrued license and milestone fees | 608 | 4,584 |
Other | 627 | 838 |
Total accrued expenses and other current liabilities | $ 88,335 | $ 57,065 |
Commitments and contingencies -
Commitments and contingencies - Additional Information (Detail) € in Millions | Nov. 18, 2016EUR (€) | Jun. 03, 2016USD ($) | Sep. 21, 2015 | Mar. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2018EUR (€) | Jun. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2016EUR (€) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Commitments And Contingencies Disclosure [Line Items] | |||||||||||||
Term of agreement | 5 years | ||||||||||||
Renewal period of agreement | 3 years | ||||||||||||
Up-front fee | € | € 3 | ||||||||||||
Up-front fee paid | € | € 1 | € 2 | |||||||||||
Annual fees | $ 29,000 | $ 1,100,000 | $ 67,000 | $ 1,520,000 | |||||||||
Termination description | The Company may terminate this agreement with twelve months’ notice and a one-time termination fee. | ||||||||||||
Decrease in letter of credit under the terms of the lease | $ 9,200,000 | ||||||||||||
Estimated future payments for 2018 | 4,000,000 | 4,000,000 | |||||||||||
Estimated future payments for 2019 | 23,000,000 | 23,000,000 | |||||||||||
Pregenen [Member] | |||||||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||||||
Contingent cash payments | 120,000,000 | 120,000,000 | |||||||||||
Pregenen [Member] | Clinical Milestone Payments [Member] | |||||||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||||||
Contingent cash payments | 20,100,000 | 20,100,000 | |||||||||||
Pregenen [Member] | Commercial Milestones Payments [Member] | |||||||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||||||
Contingent cash payments | 99,900,000 | $ 99,900,000 | |||||||||||
Building [Member] | |||||||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||||||
Useful life of asset | 40 years | ||||||||||||
Interest expense related to financing obligation | $ 3,900,000 | $ 4,100,000 | $ 11,600,000 | $ 7,800,000 | |||||||||
Letter of credit under the terms of lease | $ 13,800,000 | ||||||||||||
Maintenance and Production [Member] | |||||||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||||||
Annual fees | € | € 9.8 | ||||||||||||
Manufacturing Agreement [Member] | |||||||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||||||
Lease period | 12 years | ||||||||||||
Amount payable upon achievement of certain contractual milestones | $ 12,500,000 | ||||||||||||
Milestone payments | $ 1,500,000 | $ 2,000,000 | $ 5,500,000 | $ 5,000,000 | |||||||||
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] | |||||||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||||||
Additional contractual payables to milestones | $ 8,000,000 | ||||||||||||
Lease starting on October 1, 2016 [Member] | 60 Binney Street Lease [Member] | |||||||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||||||
Lease expiration date | Mar. 31, 2027 |
Collaborative arrangements - Ad
Collaborative arrangements - Additional Information (Detail) | Aug. 24, 2018USD ($)Target$ / sharesshares | Aug. 03, 2018USD ($) | Sep. 28, 2017USD ($) | Feb. 16, 2016USD ($) | Mar. 19, 2013USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Mar. 28, 2018USD ($) | Dec. 31, 2017USD ($) | Jun. 03, 2015USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Revenue | $ 11,528,000 | $ 7,711,000 | $ 35,336,000 | $ 31,259,000 | ||||||||||
Research and development expense | 116,744,000 | 61,545,000 | 328,867,000 | 180,464,000 | ||||||||||
Deferred revenue balance recognized as gross revenues | 32,000,000 | |||||||||||||
Investment in common stock | 29,550,000 | 14,406,000 | ||||||||||||
Collaboration [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Revenue | 10,926,000 | 5,211,000 | 33,971,000 | 18,189,000 | ||||||||||
Celgene Corporation [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Contract with customer liability | 44,831,000 | 44,831,000 | $ 76,812,000 | |||||||||||
Term of collaboration agreement | 3 years | |||||||||||||
Deferred revenue balance recognized as gross revenues | 31,981,000 | |||||||||||||
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 | |||||||||||||
Collaboration agreement, option fee received | 10,000,000 | |||||||||||||
Collaboration agreement, transaction price | 185,500,000 | 185,500,000 | ||||||||||||
Estimated variable consideration | 75,500 | 75,500 | ||||||||||||
Up-front non-refundable fees | $ 100,000,000 | |||||||||||||
Deferred revenue recognition period | 3 years | |||||||||||||
Percentage of revenue related to worldwide development cost | 67.50% | |||||||||||||
Celgene Corporation [Member] | Amended Collaborative Arrangement [Member] | Research and Development Services [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration agreement, transaction price | 36,600,000 | $ 36,600,000 | ||||||||||||
Revenue | 600,000 | 1,600,000 | 3,700,000 | 4,700,000 | ||||||||||
Celgene Corporation [Member] | bb2121 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] | bb2121 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 | |||||||||||||
Collaboration agreement, transaction price | 41,700,000 | 41,700,000 | ||||||||||||
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 | 2,900,000 | 2,900,000 | ||||||||||||
Collaboration agreement, transaction price | 5,400,000 | 5,400,000 | ||||||||||||
Revenue | 700,000 | 0 | 2,200,000 | 0 | ||||||||||
Remaining performance obligation revenue | 2,900,000 | 2,900,000 | ||||||||||||
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 | ||||||||||||
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] | bb2121 License and Manufacturing Services [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration agreement, transaction price | 148,900,000 | 148,900,000 | ||||||||||||
Revenue | $ 3,900,000 | |||||||||||||
Research and development expense | 5,300,000 | $ 3,300,000 | ||||||||||||
Gross revenue | 11,200,000 | 8,500,000 | 11,800,000 | |||||||||||
Cost reimbursement | 16,600,000 | $ 11,800,000 | $ 7,900,000 | |||||||||||
Celgene Corporation [Member] | bb2121 License and Manufacturing Services [Member] | Rest of the World [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Revenue | 9,600,000 | 24,300,000 | ||||||||||||
Celgene Corporation [Member] | bb2121 License and Manufacturing Services [Member] | ASC 605 [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Revenue | $ 7,700,000 | $ 18,600,000 | ||||||||||||
Celgene Corporation [Member] | bb2121 License and Manufacturing Services [Member] | License and Manufacturing Services [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Contract with customer liability | 32,100,000 | 32,100,000 | ||||||||||||
Remaining performance obligation revenue | $ 63,100,000 | $ 63,100,000 | ||||||||||||
Remaining performance obligation expected to be recognize as revenue, year | 2,020 | 2,020 | ||||||||||||
Regeneron Collaboration Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Research and development expense | $ 0 | $ 0 | ||||||||||||
Number of initial collaboration targets | Target | 6 | |||||||||||||
Research collaboration term | 5 years | |||||||||||||
Colloaboration 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. | |||||||||||||
Investment in common stock | 54,484,000 | |||||||||||||
Purchase price premium | $ 37,000,000 | |||||||||||||
Regeneron Collaboration Agreement [Member] | Collaboration [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Deferred revenue balance recognized as gross revenues | 0 | 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 | |||||||||||||
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 - Ch
Collaborative arrangements - Changes in Balances of Company's Receivables and Contract Liabilities (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Contract liabilities: | |
Deductions | $ (32,000) |
Celgene Corporation [Member] | |
Receivables | |
Balance at beginning of period under Topic 606 | 4,635 |
Additions | 1,641 |
Deductions | (6,276) |
Contract liabilities: | |
Balance at beginning of period under Topic 606 | 76,812 |
Deductions | (31,981) |
Balance at end of period under Topic 606 | 44,831 |
Celgene Corporation [Member] | Accrued Expenses [Member] | |
Contract liabilities: | |
Additions | 8,031 |
Deductions | (2,824) |
Balance at end of period under Topic 606 | $ 5,207 |
License and royalty revenue - A
License and royalty revenue - Additional Information (Detail) | Apr. 28, 2017USD ($)PerformanceObligation | Apr. 26, 2017USD ($)PerformanceObligation | Aug. 31, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) |
License And Royalty Revenue [Line Items] | |||||||||
Revenue | $ 11,528,000 | $ 7,711,000 | $ 35,336,000 | $ 31,259,000 | |||||
Cost of license and royalty revenue | 29,000 | 1,100,000 | 67,000 | 1,520,000 | |||||
License and Royalty [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Revenue | 602,000 | 2,500,000 | 1,365,000 | 13,070,000 | |||||
Novartis Pharma AG [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
License agreement upfront payment | $ 7,500,000 | ||||||||
Revenue recognized upon achievement of a related milestone | $ 2,500,000 | ||||||||
Novartis Pharma AG [Member] | Royalty [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Revenue | 600,000 | $ 0 | $ 0 | 1,400,000 | |||||
Novartis Pharma AG [Member] | License and Royalty [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Cost of license and royalty revenue | 1,100,000 | 1,400,000 | |||||||
Novartis Pharma AG [Member] | License and Royalty [Member] | Maximum [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Cost of license and royalty revenue | 100,000 | 100,000 | |||||||
Novartis Pharma AG [Member] | Topic 606 [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Number of performance obligation identified at the date of contract inception | PerformanceObligation | 1 | ||||||||
Revenue | 7,500,000 | ||||||||
Novartis Pharma AG [Member] | Topic 606 [Member] | Regulatory Milestones Payments [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Revenue | 2,500,000 | ||||||||
Orchard Therapeutics Limited [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
License agreement upfront payment | $ 3,000,000 | ||||||||
Orchard Therapeutics Limited [Member] | License and Royalty [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Revenue | 0 | 0 | |||||||
Cost of license and royalty revenue | 0 | 100,000 | 0 | 100,000 | |||||
Orchard Therapeutics Limited [Member] | Topic 606 [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Number of performance obligation identified at the date of contract inception | PerformanceObligation | 1 | ||||||||
Revenue | $ 3,000,000 | ||||||||
Number of unsatisfied performance obligation identified at date of contract inception | PerformanceObligation | 0 | ||||||||
Orchard Therapeutics Limited [Member] | Topic 606 [Member] | License [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Revenue | $ 0 | $ 3,000,000 | $ 0 | $ 3,000,000 | |||||
Regulatory Milestones Payments [Member] | Novartis Pharma AG [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Amount per product eligible to be received upon achievement of specified event | $ 7,500,000 | ||||||||
Each Subsequently Licensed Product [Member] | Novartis Pharma AG [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Amount per product eligible to be received upon achievement of specified event | $ 1,100,000 | ||||||||
Potential Milestones Payments [Member] | Orchard Therapeutics Limited [Member] | |||||||||
License And Royalty Revenue [Line Items] | |||||||||
Amount per product eligible to be received upon achievement of specified event | $ 1,300,000 |
Equity - Additional Information
Equity - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | Dec. 15, 2017 | Jul. 31, 2018 | Jan. 31, 2018 |
Subsidiary Sale Of Stock [Line Items] | |||
Number of shares issued in public offering | 3.2 | 0.3 | |
Shares issued, price per share | $ 185 | $ 185 | |
Proceeds from public offering of common stock, net of issuance costs | $ 569.8 | $ 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 ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Jan. 31, 2018 | Jan. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Jun. 03, 2013 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Increased number of issuance of awards under the 2013 Plan | 2,000,000 | 1,600,000 | ||||||
Number of shares available for issuance | 1,600,000 | 1,600,000 | ||||||
Stock-based compensation expense | $ 29,797,000 | $ 13,983,000 | $ 80,849,000 | $ 38,953,000 | ||||
Stock option share exercised | 535,000 | |||||||
Proceed from option share exercised | $ 28,300,000 | |||||||
Performance And Service Condition Based Restricted Stock Unit [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 0 | $ 0 | ||||||
Vested during period | 0 | 0 | ||||||
Unvested restricted stock awards outstanding | 200,000 | 200,000 | ||||||
Performance And Service Condition Based Restricted Stock Unit [Member] | Maximum [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense yet to recognize | $ 38,800,000 | $ 38,800,000 | ||||||
Stock Options [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | 22,663,000 | 10,786,000 | 60,890,000 | 30,892,000 | ||||
Unrecognized stock- based compensation expense related to unvested stock options, restricted stock awards and employee stock purchase plan | 286,400,000 | $ 286,400,000 | ||||||
Expected weighted-average period related to unvested stock options, restricted stock awards and employee stock purchase plan | 3 years | |||||||
Restricted Stock Units [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 6,918,000 | 3,067,000 | $ 19,413,000 | 7,659,000 | ||||
Vested during period | 132,000 | |||||||
Unvested restricted stock awards outstanding | 934,000 | 934,000 | 477,000 | |||||
Unrecognized stock- based compensation expense related to unvested stock options, restricted stock awards and employee stock purchase plan | $ 286,400,000 | $ 286,400,000 | ||||||
Expected weighted-average period related to unvested stock options, restricted stock awards and employee stock purchase plan | 3 years | |||||||
Employee Stock Purchase Plan [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | 216,000 | $ 130,000 | $ 546,000 | $ 402,000 | ||||
Unrecognized stock- based compensation expense related to unvested stock options, restricted stock awards and employee stock purchase plan | $ 286,400,000 | $ 286,400,000 | ||||||
Expected weighted-average period related to unvested stock options, restricted stock awards and employee stock purchase plan | 3 years | |||||||
Common shares reserved for future issuance | 238,000 | |||||||
Shares of common stock issued under plan | 16,026 | 20,773 |
Stock-based compensation - Summ
Stock-based compensation - Summary of Stock-Based Compensation Expense by Award Type (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 29,797 | $ 13,983 | $ 80,849 | $ 38,953 |
Stock Options [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 22,663 | 10,786 | 60,890 | 30,892 |
Restricted Stock Units [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 6,918 | 3,067 | 19,413 | 7,659 |
Employee Stock Purchase Plan [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 216 | $ 130 | $ 546 | $ 402 |
Stock-based compensation - Sche
Stock-based compensation - Schedule of Stock-Based Compensation Expense by Classification (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 29,797 | $ 13,983 | $ 80,849 | $ 38,953 |
Research And Development [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 14,445 | 7,049 | 40,265 | 19,500 |
General And Administrative [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 15,352 | $ 6,934 | $ 40,584 | $ 19,453 |
Stock-based compensation - Su_2
Stock-based compensation - Summary of Stock Option Activity Under Plan (Detail) shares in Thousands | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Shares | |
Outstanding at beginning of period | shares | 3,755 |
Granted | shares | 1,416 |
Exercised | shares | (535) |
Canceled or forfeited | shares | (97) |
Outstanding at end of period | shares | 4,539 |
Exercisable at end of period | shares | 2,035 |
Vested and expected to vest at end of period | shares | 4,507 |
Weighted-average exercise price per share | |
Outstanding at beginning of period | $ / shares | $ 67.91 |
Granted | $ / shares | 193 |
Exercised | $ / shares | 52.87 |
Canceled or forfeited | $ / shares | 134.63 |
Outstanding at end of period | $ / shares | 107.28 |
Exercisable at end of period | $ / shares | 60.91 |
Vested and expected to vest at end of period | $ / shares | $ 107.32 |
Stock-based compensation - Su_3
Stock-based compensation - Summary of Restricted Stock Units (Detail) - Restricted Stock Units [Member] shares in Thousands | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Shares | |
Unvested balance at beginning of period | shares | 477 |
Granted | shares | 626 |
Vested | shares | (132) |
Forfeited | shares | (37) |
Unvested balance at end of period | shares | 934 |
Weighted-average grant date fair value | |
Unvested balance at beginning of period | $ / shares | $ 80.72 |
Granted | $ / shares | 197.79 |
Vested | $ / shares | 81.80 |
Forfeited | $ / shares | 159.04 |
Unvested balance at end of period | $ / shares | $ 155.94 |
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 | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from the calculation of diluted net loss per share | 5,483 | 4,482 |
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 | 4,539 | 4,016 |
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 | 934 | 456 |
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 | 10 | 10 |
Subsequent events - Additional
Subsequent events - Additional Information (Detail) $ in Millions | Oct. 11, 2018USD ($) |
Subsequent Event | Manufacturing Agreement [Member] | Minimum [Member] | |
Subsequent Event [Line Items] | |
Amount payable upon achievement of certain contractual milestones | $ 197.7 |