Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 31, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | Moderna, Inc. | |
Entity Central Index Key | 0001682852 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Small Business | false | |
Entity Common Stock, Shares Outstanding | 330,182,202 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 151,624 | $ 658,364 |
Investments | 918,722 | 863,063 |
Accounts receivable | 3,498 | 11,686 |
Accounts receivable from related party | 1,020 | 899 |
Prepaid expenses and other current assets | 22,492 | 28,399 |
Restricted cash | 62 | 595 |
Total current assets | 1,097,418 | 1,563,006 |
Investments, non-current | 365,032 | 172,990 |
Property and equipment, net | 208,509 | 211,977 |
Restricted cash, non-current | 11,762 | 11,532 |
Other non-current assets | 2,558 | 2,644 |
Total assets | 1,685,279 | 1,962,149 |
Current liabilities: | ||
Accounts payable | 29,609 | 31,210 |
Accrued liabilities | 44,589 | 79,073 |
Deferred revenue | 83,401 | 109,056 |
Other current liabilities | 4,388 | 3,464 |
Total current liabilities | 161,987 | 222,803 |
Deferred revenue, non-current | 139,923 | 165,352 |
Deferred lease obligation, non-current | 11,039 | 10,006 |
Lease financing obligation | 33,588 | 33,489 |
Other non-current liabilities | 188 | 258 |
Total liabilities | 346,725 | 431,908 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, par value $0.0001; 162,000,000 shares authorized as of June 30, 2019 and December 31, 2018; no shares issued or outstanding at June 30, 2019 and December 31, 2018 | 0 | 0 |
Common stock, par value $0.0001; 1,600,000,000 shares authorized as of June 30, 2019 and December 31, 2018; 329,958,172 and 328,798,904 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | 33 | 33 |
Additional paid-in capital | 2,582,134 | 2,538,155 |
Accumulated other comprehensive income (loss) | 2,741 | (1,320) |
Accumulated deficit | (1,246,354) | (1,006,627) |
Total stockholders’ equity | 1,338,554 | 1,530,241 |
Total liabilities and stockholders’ equity | $ 1,685,279 | $ 1,962,149 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 162,000,000 | 162,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 1,600,000,000 | 1,600,000,000 |
Common stock, shares issued | 329,958,172 | 328,798,904 |
Common stock, shares outstanding | 329,958,172 | 328,798,904 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenue: | ||||
Total revenue | $ 13,083 | $ 28,851 | $ 29,108 | $ 57,890 |
Operating expenses: | ||||
Research and development | 128,496 | 104,479 | 259,071 | 194,603 |
General and administrative | 28,523 | 21,387 | 55,806 | 37,704 |
Total operating expenses | 157,019 | 125,866 | 314,877 | 232,307 |
Loss from operations | (143,936) | (97,015) | (285,769) | (174,417) |
Interest income | 10,322 | 6,401 | 21,294 | 11,610 |
Other (expense) income, net | (1,764) | 171 | (3,584) | (12) |
Loss before income taxes | (135,378) | (90,443) | (268,059) | (162,819) |
(Benefit from) provision for income taxes | (324) | 158 | (348) | 158 |
Net loss | (135,054) | (90,601) | (267,711) | (162,977) |
Net loss attributable to common stockholders (Note 11) | $ (135,054) | $ (94,082) | $ (267,711) | $ (169,939) |
Net loss per share attributable to common stockholders, basic and diluted (usd per share) | $ (0.41) | $ (1.43) | $ (0.81) | $ (2.59) |
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted (in shares) | 329,176,107 | 65,938,939 | 328,994,058 | 65,686,290 |
Collaboration revenue | ||||
Revenue: | ||||
Total revenue | $ 9,842 | $ 19,742 | $ 23,143 | $ 39,852 |
Collaboration revenue from related party | ||||
Revenue: | ||||
Total revenue | 188 | 6,089 | 1,002 | 13,439 |
Grant revenue | ||||
Revenue: | ||||
Total revenue | $ 3,053 | $ 3,020 | $ 4,963 | $ 4,599 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (135,054) | $ (90,601) | $ (267,711) | $ (162,977) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale debt securities, net of tax, $608 and $0, for three months ended June 30, 2019 and 2018, respectively, and net of tax, $1,148 and $0, for six months ended June 30, 2019 and 2018, respectively | 2,167 | 1,738 | 4,075 | (261) |
Less: amounts recognized for net realized gains included in net loss | (17) | (597) | (14) | (591) |
Total other comprehensive income (loss) | 2,150 | 1,141 | 4,061 | (852) |
Comprehensive loss | $ (132,904) | $ (89,460) | $ (263,650) | $ (163,829) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Unrealized gain (loss) on available-for-sale debt securities, tax | $ 608 | $ 0 | $ 1,148 | $ 0 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Series G Preferred Stock | Series H Preferred Stock | Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred StockSeries G Preferred Stock | Redeemable Convertible Preferred StockSeries H Preferred Stock | Common Stock | Additional Paid-In Capital | Additional Paid-In CapitalSeries G Preferred Stock | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at beginning of period (in shares) at Dec. 31, 2017 | 448,686,791 | 65,206,999 | |||||||||
Balance at beginning of period at Dec. 31, 2017 | $ (551,365) | $ 1,176,661 | $ 6 | $ 71,679 | $ (1,157) | $ (621,893) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Vesting of restricted common stock (in shares) | 650,329 | ||||||||||
Vesting of restricted common stock | 0 | ||||||||||
Exercise of options to purchase common stock, net (in shares) | 347,468 | ||||||||||
Exercise of options to purchase common stock, net | 70 | 70 | |||||||||
Issuance of redeemable convertible preferred stock, net of issuance costs of (in shares) | 55,666,004 | 5,000,000 | |||||||||
Issuance of redeemable convertible preferred stock, net of issuance costs | 152 | $ 549,413 | $ 111,546 | $ 152 | |||||||
Payments of Stock Issuance Costs | $ 10,517 | $ 474 | |||||||||
Stock-based compensation | 26,204 | 26,204 | |||||||||
Unrealized gain (loss) on marketable securities | (852) | (852) | |||||||||
Net loss | (162,977) | (162,977) | |||||||||
Balance at end of period (in shares) at Jun. 30, 2018 | 509,352,795 | 66,204,796 | |||||||||
Balance at end of period at Jun. 30, 2018 | (688,768) | $ 1,837,620 | $ 6 | 98,105 | (2,009) | (784,870) | |||||
Balance at beginning of period (in shares) at Mar. 31, 2018 | 504,352,795 | 65,543,841 | |||||||||
Balance at beginning of period at Mar. 31, 2018 | (613,709) | $ 1,726,074 | $ 6 | 83,704 | (3,150) | (694,269) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Vesting of restricted common stock (in shares) | 315,276 | ||||||||||
Vesting of restricted common stock | 0 | ||||||||||
Exercise of options to purchase common stock, net (in shares) | 345,679 | ||||||||||
Exercise of options to purchase common stock, net | 48 | 48 | |||||||||
Issuance of redeemable convertible preferred stock, net of issuance costs of (in shares) | 5,000,000 | ||||||||||
Issuance of redeemable convertible preferred stock, net of issuance costs | $ 111,546 | ||||||||||
Payments of Stock Issuance Costs | 474 | ||||||||||
Stock-based compensation | 14,353 | 14,353 | |||||||||
Unrealized gain (loss) on marketable securities | 1,141 | 1,141 | |||||||||
Net loss | (90,601) | (90,601) | |||||||||
Balance at end of period (in shares) at Jun. 30, 2018 | 509,352,795 | 66,204,796 | |||||||||
Balance at end of period at Jun. 30, 2018 | (688,768) | $ 1,837,620 | $ 6 | 98,105 | (2,009) | (784,870) | |||||
Balance at beginning of period (in shares) at Dec. 31, 2018 | 328,798,904 | ||||||||||
Balance at beginning of period at Dec. 31, 2018 | 1,530,241 | $ 33 | 2,538,155 | (1,320) | (1,006,627) | ||||||
Balance at end of period (in shares) at Mar. 31, 2019 | 328,853,340 | ||||||||||
Balance at end of period at Mar. 31, 2019 | 1,446,033 | $ 33 | 2,556,709 | 591 | (1,111,300) | ||||||
Balance at beginning of period (in shares) at Dec. 31, 2018 | 328,798,904 | ||||||||||
Balance at beginning of period at Dec. 31, 2018 | 1,530,241 | $ 33 | 2,538,155 | (1,320) | (1,006,627) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Vesting of restricted common stock (in shares) | 107,475 | ||||||||||
Vesting of restricted common stock | $ 0 | ||||||||||
Exercise of options to purchase common stock, net (in shares) | 1,051,793 | 1,051,793 | |||||||||
Exercise of options to purchase common stock, net | $ 3,987 | 3,987 | |||||||||
Stock-based compensation | 39,992 | 39,992 | |||||||||
Unrealized gain (loss) on marketable securities | 4,061 | 4,061 | |||||||||
Net loss | (267,711) | (267,711) | |||||||||
Balance at end of period (in shares) at Jun. 30, 2019 | 329,958,172 | ||||||||||
Balance at end of period at Jun. 30, 2019 | 1,338,554 | $ 33 | 2,582,134 | 2,741 | (1,246,354) | ||||||
Balance at beginning of period (in shares) at Mar. 31, 2019 | 328,853,340 | ||||||||||
Balance at beginning of period at Mar. 31, 2019 | 1,446,033 | $ 33 | 2,556,709 | 591 | (1,111,300) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Vesting of restricted common stock (in shares) | 58,564 | ||||||||||
Vesting of restricted common stock | 0 | ||||||||||
Exercise of options to purchase common stock, net (in shares) | 1,046,268 | ||||||||||
Exercise of options to purchase common stock, net | 3,930 | 3,930 | |||||||||
Stock-based compensation | 21,495 | 21,495 | |||||||||
Unrealized gain (loss) on marketable securities | 2,150 | 2,150 | |||||||||
Net loss | (135,054) | (135,054) | |||||||||
Balance at end of period (in shares) at Jun. 30, 2019 | 329,958,172 | ||||||||||
Balance at end of period at Jun. 30, 2019 | $ 1,338,554 | $ 33 | $ 2,582,134 | $ 2,741 | $ (1,246,354) |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2018 | Jun. 30, 2018 | |
Issuance costs | $ 474 | |
Series G Preferred Stock | ||
Issuance costs | $ 10,517 | |
Series H Preferred Stock | ||
Issuance costs | $ 474 |
CONDENSED CONSOLIDATED STATEM_6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Operating activities | ||
Net loss | $ (267,711) | $ (162,977) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 39,992 | 26,204 |
Depreciation and amortization | 14,817 | 11,031 |
Amortization of investment premiums | (2,360) | (531) |
Loss on disposal of property and equipment | 14 | 0 |
Changes in assets and liabilities: | ||
Accounts receivable | 8,188 | 489 |
Accounts receivable from related party | (121) | 766 |
Prepaid expenses and other assets | 2,315 | (8,872) |
Accounts payable | (1,471) | (1,340) |
Accrued liabilities | (27,796) | (24,959) |
Deferred revenue | (23,100) | (2,283) |
Deferred lease obligation | 1,033 | 2,046 |
Other liabilities | 53 | 792 |
Net cash used in operating activities | (256,147) | (159,634) |
Investing activities | ||
Purchases of marketable securities | (843,313) | (837,984) |
Proceeds from maturities of marketable securities | 563,634 | 298,376 |
Proceeds from sales of marketable securities | 39,200 | 110,248 |
Purchases of property and equipment | (18,181) | (65,989) |
Net cash used in investing activities | (258,660) | (495,349) |
Financing activities | ||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | 0 | 661,111 |
Proceeds from issuance of common stock through equity plans | 3,987 | 70 |
Reimbursement of assets under lease financing obligation | 3,678 | 1,747 |
Payments on financing lease obligation | 99 | (2,571) |
Net cash provided by financing activities | 7,764 | 660,357 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (507,043) | 5,374 |
Cash, cash equivalents and restricted cash, beginning of year | 670,491 | 147,608 |
Cash, cash equivalents and restricted cash, end of period | 163,448 | 152,982 |
Non-cash investing and financing activities | ||
Purchases of property and equipment included in accounts payable and accrued liabilities | 6,074 | 28,181 |
Leasehold improvements included in prepaid and other current assets | 6,310 | 13,567 |
Lease financing obligation | $ 0 | $ 13,567 |
Description of the Business
Description of the Business | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of the Business | Description of the Business Moderna, Inc. is a Delaware corporation, incorporated under the laws of the State of Delaware on July 22, 2016 (collectively, with its consolidated subsidiaries, any of Moderna, Company, we, us or our). In August 2018, we changed our name from Moderna Therapeutics, Inc. to Moderna, Inc. We are the successor in interest to Moderna LLC, a limited liability company formed under the laws of the State of Delaware in 2013. We are creating a new generation of potentially transformative medicines based on messenger RNA (mRNA), to improve the lives of patients. Since inception, we have incurred significant net losses. We expect to continue to incur significant expenses and operating losses for the foreseeable future. In addition, we anticipate that our expenses will increase significantly in connection with our ongoing activities to support our platform research, drug discovery and clinical development, infrastructure and Research Engine and Early Development engine, digital infrastructure, creation of a portfolio of intellectual property, and administrative support. We do not expect to generate significant revenue from sales of potential mRNA medicines unless and until we successfully complete clinical development and obtain regulatory approval for one or more of our investigational medicines. If we seek to obtain regulatory approval for any of our investigational medicines, we expect to incur significant commercialization expenses. As a result, we will need substantial additional funding to support our continued operations and pursue our growth strategy. Until we can generate significant revenue from potential mRNA medicines, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings, government funding arrangements, strategic alliances and marketing, distribution and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our programs. We believe that our cash, cash equivalents, and investments as of June 30, 2019 will be sufficient to enable us to fund our projected operations through at least the next 12 months from the issuance of these financial statements. Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenues from the sale of our medicines, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations. |
Summary of Basis of Presentatio
Summary of Basis of Presentation and Recent Accounting Standards | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Basis of Presentation and Recent Accounting Standards | Summary of Basis of Presentation and Recent Accounting Standards Basis of Presentation and Principles of Consolidation The accompanying unaudited condensed consolidated financial statements that accompany these notes have been prepared in conformity with U.S. generally accepted accounting principles (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting, consistent in all material respects with those applied in our Annual Report on Form 10-K for the year ended December 31, 2018 (2018 Form 10-K), except for changes associated with recent accounting standards for revenue recognition as detailed in "Note 2 - Recent Accounting Standards and Accounting Policies." This report should be read in conjunction with the consolidated financial statements in our 2018 Form 10-K. We have made estimates and judgments affecting the amounts reported in our condensed consolidated financial statements and the accompanying notes. On an ongoing basis, we evaluate our estimates, including critical accounting policies or estimates related to revenue recognition, research and development expense, income tax provisions, stock-based compensation, and useful lives of long-lived assets. We base our estimates on historical experience and on various relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. The actual results that we experience may differ materially from our estimates. The condensed consolidated financial statements reflect all normal recurring adjustments necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, but are not necessarily indicative of the results of operations to be anticipated for the full year ending December 31, 2019. Recent Accounting Standards and Accounting Policies Revenue Recognition On January 1, 2019, we adopted Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers (ASC 606), using the modified retrospective transition method applied to those contracts which were not completed as of January 1, 2019. We recognized the cumulative effect of the adoption as an adjustment to the opening balance of accumulated deficit in the current period condensed consolidated balance sheet. Results for reporting periods beginning after January 1, 2019 are presented under ASC 606, while prior period amounts have not been adjusted and continue to be reported in accordance with our historic accounting under ASC Topic 605, Revenue Recognition (ASC 605). ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Our revenue is primarily generated through collaboration arrangements and grants from government-sponsored and private organizations. Our collaboration arrangements typically contain multiple promises, including licenses to our intellectual property, options to obtain development and commercialization rights, research and development services, and obligations to develop and manufacture preclinical and clinical material. Such arrangements provide for various types of payments to us, including upfront payments, funding of research and development activities, funding for the purchase of preclinical and clinical material, development, regulatory and commercial milestone payments, licensing fees, option exercise payments, and royalties based on product sales. We have received grants from various government-sponsored and private organizations for research and related activities that provide for payments for reimbursed costs, which may include overhead and general and administrative costs as well as a related profit margin. We analyze our collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, we assess whether aspects of the arrangement between us and our collaboration partner are within the scope of other accounting literature. If we conclude that some or all aspects of the arrangement represent a transaction with a customer, we account for those aspects of the arrangement within the scope of ASC 606 . If we conclude that some or all aspects of the arrangement are within the scope of ASC 808 and do not represent a transaction with a customer, we recognize our allocation of the shared costs incurred with respect to the jointly conducted activities as a component of the related expense in the period incurred. Pursuant to ASC 606, a customer is a party that has contracted with an entity to obtain goods or services that are an output of the entity’s ordinary activities in exchange for consideration. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. If we conclude a counter-party to a transaction is not a customer or otherwise not within the scope of ASC 606 or ASC 808, we consider the guidance in other accounting literature as applicable or by analogy to account for such transaction. We also consider the guidance in ASC 606 with respect to principal versus agent considerations, in determining the appropriate treatment for the transactions between us and the strategic collaborator and the transactions between us and other third parties. The classification of transactions under our arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. Any consideration related to activities in which we are considered the principal, which includes being in control of the good or service before such good or service is transferred to the customer, are accounted for as gross revenue. We receive payments from our customers based on billing schedules established in each contract. Upfront payments and fees are recorded as contract liabilities upon receipt or when due and may require deferral of revenue recognition to a future period when we perform our obligations under the arrangement. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current liabilities on our condensed consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as non-current liabilities on our condensed consolidated balance sheets. Amounts payable to us are recorded as accounts receivable when our right to consideration is unconditional. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less or the amount is immaterial. As of June 30, 2019 , we had not capitalized any costs to obtain any of our contracts. Collaboration Revenue To determine the appropriate amount of revenue to be recognized for arrangements that we determine are within the scope of ASC 606, we perform the following steps: (i) identify the contract(s) with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) each performance obligation is satisfied. We account for a contract with a customer that is within the scope of ASC 606 when all of the following criteria are met: (i) the arrangement has been approved by the parties and the parties are committed to perform their respective obligations; (ii) each party’s rights regarding the goods and/or services to be transferred can be identified; (iii) the payment terms for the goods and/or services to be transferred can be identified; (iv) the arrangement has commercial substance; and (v) collection of substantially all of the consideration to which we will be entitled in exchange for the goods and/or services that will be transferred to the customer is probable. We also determine the term of the contract based on the period in which we and our customer have present and enforceable rights and obligations for purposes of identifying the performance obligations and determining the transaction price. We evaluate contracts that contain multiple promises to determine which promises are distinct. Promises are considered to be distinct and therefore, accounted for as separate performance obligations, 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 and (ii) the promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. In assessing whether a promise is distinct, we consider factors such as whether: (i) we provide a significant service of integrating goods and/or services with other goods and/or services promised in the contract; (ii) one or more of the goods and/or services significantly modifies or customizes, or are significantly modified or customized by one or more of the other goods and/or services promised in the contract; and (iii) the goods and/or services are highly interdependent or highly interrelated. Individual goods or services (or bundles of goods and/or services) that meet both criteria for being distinct are accounted for as separate performance obligations. Promises that are not distinct at contract inception are combined and accounted for as a single performance obligation. Options to acquire additional goods and/or services are evaluated to determine if such option provides a material right to the customer that it would not have received without entering into the contract. If so, the option is accounted for as a separate performance obligation. If not, the option is considered a marketing offer which would be accounted for as a separate contract upon the customer’s election. The transaction price is generally comprised of an upfront payment due at contract inception and variable consideration in the form of payments for our services and materials and milestone payments due upon the achievement of specified events. Other payments the Company could be entitled to include tiered royalties earned when customers recognize net sales of licensed products. We consider the existence of any significant financing component within our arrangements and have determined that a significant financing component does not exist in our arrangements as substantive business purposes exist to support the payment structure other than to provide a significant benefit of financing. We measure the transaction price based on the amount of consideration we expect to be entitled in exchange for transferring the promised goods and/or services to the customer. We utilize either the expected value method or the most likely amount method to estimate the amount of variable consideration, depending on which method is expected to better predict the amount of consideration to which we will be entitled. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. With respect to arrangements that include payments for a development or regulatory milestone payment, we evaluate whether the associated event is considered probable of achievement and estimate the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within our control or the licensee, such as those dependent upon receipt of regulatory approval, are not considered to be probable of achievement until the triggering event occurs. At the end of each reporting period, we re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, wherein the license is deemed to be the sole or predominant item to which the payments relate, we recognize revenue upon the later of: (i) when the related sales occur or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception. We generally allocate the transaction price to each performance obligation based on a relative standalone selling price basis. We develop assumptions that require judgment to determine the standalone selling price for each performance obligation in consideration of applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated research and development costs. However, in certain instances, we allocate variable consideration entirely to one or more performance obligation if the terms of the variable consideration relate to the satisfaction of the respective performance obligation and the amount allocated is consistent with the amount we would expect to receive for the satisfaction of the respective performance obligation. We recognize revenue based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good or service to the customer. For performance obligations that are satisfied at a point in time, we recognize revenue when control of the goods and/or services is transferred to the customer. For performance obligations that are satisfied over time, we recognize revenue by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress which depicts the performance in transferring control of the associated goods and/or services to the customer. We generally use input methods to measure the progress toward the complete satisfaction of performance obligations satisfied over time. With respect to arrangements containing a license to our intellectual property that is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenue from amounts allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. Grant Revenue We have contracts with the U.S. government’s Defense Advanced Research Projects Agency (DARPA), Biomedical Advanced Research (BARDA), and the Bill & Melinda Gates Foundation (Gates Foundation). We recognize revenue from these contracts as we perform services under these arrangements when the funding is committed. Revenues and related expenses are presented gross in the condensed consolidated statements of operations as we have determined we are the primary obligor under the arrangements relative to the research and development services we perform as lead technical expert. Comprehensive Loss Comprehensive loss includes net loss and other comprehensive income (loss) for the period. Other comprehensive income (loss) consists of unrealized gains and losses on our investments. Total comprehensive loss for all periods presented has been disclosed in the condensed consolidated statements of comprehensive loss. The components of accumulated other comprehensive income for the three and six months ended June 30, 2019 are as follows (in thousands): Unrealized Gain on Available-for-Sale Debt Securities June 30, 2019 Accumulated other comprehensive loss, balance at December 31, 2018 $ (1,320 ) Other comprehensive income 1,911 Accumulated other comprehensive income, balance at March 31, 2019 591 Other comprehensive income 2,150 Accumulated other comprehensive income, balance at June 30, 2019 $ 2,741 Emerging Growth Company Status We are an “emerging growth company,” (EGC) as defined in the Jumpstart Our Business Startups Act, (JOBS Act), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. We may take advantage of these exemptions until we are no longer an EGC under Section 107 of the JOBS Act, which provides that an EGC can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. We have elected to use the extended transition period for complying with new or revised accounting standards, and as a result of this election, our condensed consolidated financial statements may not be comparable to companies that comply with public company FASB standards’ effective dates. As of June 30, 2019, we determined that we will become a large accelerated filer under the rules of the SEC and we will no longer be classified as an EGC as of December 31, 2019. Recently Adopted Accounting Standards ASU No. 2014-09, Revenue from Contracts with Customers In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) , which supersedes all existing revenue recognition requirements in ASC 605 and most industry specific guidance. ASC 606 provides a single comprehensive model for use in accounting for revenue arising from contracts with customers. We adopted the new revenue standard on January 1, 2019 using the modified retrospective transition method applied to those contracts which were not completed as of January 1, 2019. We recognized the cumulative effect of the adoption as an adjustment to the opening balance of accumulated deficit in the first quarter of 2019. We have elected to use the practical expedient to aggregate the impact of all contract modifications that occurred prior to the ASC 606 adoption with respect to (i) identification of the satisfied and unsatisfied performance obligations, (ii) determination of the transaction price and (iii) allocation of the transaction price to the satisfied and unsatisfied performance obligations. ASC 606 requires significant judgment and estimates and results in changes to, but not limited to: (i) the determination of the transaction price, including estimates of variable consideration, (ii) the allocation of the transaction price, including the determination of estimated selling price, and (iii) the pattern of recognition, including the application of proportional performance as a measure of progress on service-related promises and application of point-in-time recognition for supply-related promises. We recorded the cumulative-effect adjustment of $28.0 million to the opening balance of accumulated deficit as of January 1, 2019 with a corresponding decrease to deferred revenue. The effect of the adoption of ASC 606 on our condensed consolidated balance sheet is as follows (in thousands): Condensed Consolidated Balance Sheet Balance at December 31, 2018 Adjustments Balance at January 1, 2019 Deferred revenue, current $ 109,056 $ (27,281 ) $ 81,775 Deferred revenue, non-current 165,352 (3,441 ) 161,911 Accounts receivable 11,686 (2,738 ) 8,948 Accumulated deficit (1,006,627 ) 27,984 (978,643 ) The cumulative-effect adjustment is primarily due to the application of ASC 606 to our strategic collaboration agreements, particularly our Combined 2018 AZ Agreements, 2016 VEGF Exercise and Merck PCV/SAV Agreement (see Note 3). In addition, as a result of the cumulative decrease in deferred revenue, our corresponding deferred tax asset was decreased by $8.4 million , which was offset by a corresponding decrease to our valuation allowance. A substantial portion of the $28.0 million cumulative-effect adjustment is the result of the application of ASC 606 regarding the allocation of the transaction price and the measurement of progress in satisfying performance obligations. In particular, for the Combined 2018 AZ Agreements, the adoption of ASC 606 resulted in the decrease of previously deferred revenue of $39.9 million . For the Merck PCV/SAV Agreement, the adoption of ASC 606 resulted in a reversal of previously recognized revenue and an increase in deferred revenue of $13.9 million . These adjustments are due to the change in the way we allocate the transaction price to each performance obligation and measure our performance under each agreement from a straight-line method to a proportional performance model. In addition, the adoption of ASC 606 resulted in the decrease of $4.3 million of previously deferred revenue relating to the 2016 VEGF Exercise. Under ASC 605, the product option fee and the clinical milestone payment we received pursuant to the VEGF Exercise were deferred until the consideration pertaining to the clinical supply of mRNA can be reasonably estimated. Under ASC 606, we are required to estimate the total variable consideration to determine the total consideration and recognize the revenue as clinical supply is shipped to the customer based on the proportionate amount of the transaction price. As a result, the balance of remaining deferred revenues at January 1, 2019 was $75.7 million , $37.1 million and $125.2 million related to the Combined 2018 AZ Agreements, 2016 VEGF Exercise and the Merck PCV/SAV Agreement, respectively. The following tables summarize the effects of adopting ASC 606 on our condensed consolidated financial statements at June 30, 2019, and for the three and six months ended June 30, 2019 (in thousands, except per share data): June 30, 2019 Condensed Consolidated Balance Sheet As reported under ASC 606 Adjustments Balance without adoption of ASC 606 Deferred revenue, current $ 83,401 $ 3,266 $ 86,667 Deferred revenue, non-current 139,923 1,936 141,859 Accumulated deficit (1,246,354 ) (1,595 ) (1,247,949 ) Three Months Ended June 30, 2019 Condensed Consolidated Statement of Operations As reported under ASC 606 Adjustments Amount without adoption of ASC 606 Revenue: Collaboration revenue $ 9,842 $ 3,155 $ 12,997 Collaboration revenue from related party 188 642 830 Total revenue 13,083 3,797 16,880 Loss from operations (143,936 ) 3,797 (140,139 ) Loss before income taxes (135,378 ) 3,797 (131,581 ) Net loss (135,054 ) 3,797 (131,257 ) Net loss per share - basic and diluted (0.41 ) 0.01 (0.40 ) Six Months Ended June 30, 2019 Condensed Consolidated Statement of Operations As reported under ASC 606 Adjustments Amount without adoption of ASC 606 Revenue: Collaboration revenue $ 23,143 $ 1,369 $ 24,512 Collaboration revenue from related party 1,002 25,019 26,021 Total revenue 29,108 26,388 55,496 Loss from operations (285,769 ) 26,388 (259,381 ) Loss before income taxes (268,059 ) 26,388 (241,671 ) Net loss (267,711 ) 26,388 (241,323 ) Net loss per share - basic and diluted (0.81 ) 0.08 (0.73 ) ASU No. 2016-18, Statement of Cash Flows: Restricted Cash In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash , which requires the statement of cash flows to explain the change during the period in the total of cash, cash equivalents and restricted cash. When cash, cash equivalents and restricted cash are presented in more than one line item on the balance sheet, the new standard requires a reconciliation of the totals in the statement of cash flows to the related captions in the balance sheet. This reconciliation can be presented either on the face of the statement of cash flows or in the notes to the financial statements. The new standard became effective for us on January 1, 2019. As a result of adopting this new standard using a retrospective transition method for each period presented, we include our restricted cash balance in the cash, cash equivalents and restricted cash reconciliation of operating, investing and financing activities in the condensed consolidated statements of cash flows. The following table provides a reconciliation of cash, cash equivalents and restricted cash in the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands): As of June 30, 2019 2018 Cash and cash equivalents $ 151,624 $ 140,619 Restricted cash 62 831 Restricted cash, non-current 11,762 11,532 Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows $ 163,448 $ 152,982 ASU No. 2018-07, Compensation - Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance generally consistent with the accounting for employee share-based compensation. The new standard will be effective for us on January 1, 2020, with early adoption permitted. We early adopted this standard in the first quarter of 2019. The adoption of this standard did not have a material impact on our condensed consolidated financial statements and disclosure. ASU No. 2018-18, Collaborative Arrangements: Clarifying the Interaction between Topic 808 and Topic 606 In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808) : Clarifying the Interaction between Topic 808 and Topic 606, which clarifies the interaction between Topic 808 and Topic 606, Revenue from Contracts with Customers . Currently, Topic 808 does not provide comprehensive recognition or measurement guidance for collaborative arrangements, and the accounting for those arrangements is often based on an analogy to other accounting literature or an accounting policy election. Similarly, aspects of Topic 606 have resulted in diversity in practice on the effect of the revenue standard on the accounting for collaborative arrangements. The standard will become effective for us beginning on January 1, 2021, with early adoption permitted. We early adopted this standard in connection with the adoption of ASC 606 in the first quarter of 2019. The adoption of this standard did not have a material impact on our condensed consolidated financial statements and disclosure. Recently Issued Accounting Standards From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our condensed consolidated financial statements and disclosures. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which supersedes all existing lease guidance. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. The new standard requires lessees to recognize an operating lease with a term greater than one year on their balance sheets as a right-of-use asset and corresponding lease liability, measured at the present value of the lease payments. Lessees are required to classify leases as either finance or operating leases. If the lease is effectively a financed-purchase by the lessee, it is classified as a financing lease, otherwise it is classified as an operating lease. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. ASC 842 provides accounting guidance for transactions that meet specific criteria for a leaseback transaction. If the criteria are not met, the transaction is considered a “failed sale” and the transaction must be accounted for as a financing arrangement. The new standard will be effective for us on December 31, 2019. Upon adoption, the new standard, as amended, allows lessees to apply the transition requirements either (1) retrospectively to each prior reporting period presented in the financial statements with the cumulative effect of applying the new rules recognized at the beginning of the earliest comparative period presented, or (2) retrospectively at the beginning of the period of adoption with the cumulative effect of applying the new rules recognized then. We are currently evaluating the potential impact ASU 2016-02 may have on our financial position and results of operations. Our assessment will include, but is not limited to, evaluating the impact this standard has on the lease of our corporate headquarters at 200 Technology Square in Cambridge, MA, the lease of our office and laboratory space at 500 Technology Square, Cambridge, MA and our manufacturing and additional facilities in Norwood, MA, (see Note 7), and the identification of any embedded leases. In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (ASU 2016-13). ASU 2016-13 will change how companies account for credit losses for most financial assets and certain other instruments. For trade receivables, loans and held-to-maturity debt securities, companies will be required to recognize an allowance for credit losses rather than reducing the carrying value of the asset. ASU 2016-13 will be effective for us on January 1, 2020, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the potential impact that the adoption of ASU 2016-13 will have on the Company’s financial position and results of operations. In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Topic 350): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. This standard requires capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This standard should be applied either retrospectively or prospectively, and will be effective for us on January 1, 2020, with early adoption permitted. We are currently evaluating the potential impact this standard may have on our condensed consolidated financial statements and results of operations upon adoption. |
Collaboration Agreements
Collaboration Agreements | 6 Months Ended |
Jun. 30, 2019 | |
Research and Development [Abstract] | |
Collaboration Agreements | Collaboration Agreements The following table summarizes our total consolidated net revenue from our strategic collaborators for the periods presented (in thousands): Three Months Ended Collaboration Revenue by Strategic Collaborator: June 30, 2019 as reported (under ASU 606) June 30, 2019 without adoption of 606 (under ASC 605) June 30, 2018 as reported (under ASC 605) Merck $ 8,659 $ 8,802 $ 17,095 AstraZeneca 188 830 6,089 Vertex 1,183 4,195 2,390 Total collaboration revenue $ 10,030 $ 13,827 $ 25,574 Six Months Ended Collaboration Revenue by Strategic Collaborator: June 30, 2019 as reported (under ASU 606) June 30, 2019 without adoption of 606 (under ASC 605) June 30, 2018 as reported (under ASC 605) Merck $ 19,346 $ 20,317 $ 33,062 AstraZeneca 1,002 26,021 13,439 Vertex 3,797 4,195 6,533 Total collaboration revenue $ 24,145 $ 50,533 $ 53,034 The following table presents changes in the balances of our receivables and contract liabilities related to our strategic collaboration agreements during the six months ended June 30, 2019 (in thousands): January 1, 2019 Additions Deductions June 30, 2019 Contract Assets: Accounts receivable $ 4,612 $ 5,110 $ (5,204 ) $ 4,518 Contract Liabilities: Deferred revenue $ 240,924 $ 2,292 $ (25,165 ) $ 218,051 During the three and six months ended June 30, 2019 , we recognized the following revenue as a result of the change in the contract liability balances related to our collaboration agreements (in thousands): Revenue recognized in the period from: Three Months Ended June 30, 2019 Six Months Ended June 30, 2019 Amounts included in contract liabilities at the beginning of the period (1) $ 11,583 $ 25,165 (1) We first allocate revenue to the individual contract liability balance outstanding at the beginning of the period until the revenue exceeds that balance. If additional consideration is received on those contracts in subsequent periods, we assume all revenue recognized in the reporting period first applies to the beginning contract liability. As of June 30, 2019 , the aggregated amount of the transaction price allocated to performance obligations under our collaboration agreements that are unsatisfied or partially unsatisfied was $268.2 million . AstraZeneca – Strategic Alliances in Cardiovascular and Oncology 2013 Option Agreement and Services and Collaboration Agreement In March 2013, we entered into an Option Agreement, the AZ Option Agreement, and a related Services and Collaboration Agreement, the AZ Services Agreement, with AstraZeneca, which were amended and restated in June 2018. We refer to these agreements in the forms that existed prior to the 2018 amendment and restatement as the 2013 AZ Agreements. Under the 2013 AZ Agreements, we granted AstraZeneca certain exclusive rights and licenses, and options to obtain exclusive rights to develop and commercialize potential therapeutic mRNA medicines directed at certain targets for the treatment of cardiovascular and cardiometabolic diseases and cancer, and agreed to provide related services to AstraZeneca. Pursuant to the 2013 AZ Agreements, AstraZeneca was responsible for all research, development and commercialization activities, while we provided specified research and manufacturing services during a research and evaluation period, as described below, to further AstraZeneca’s activities pursuant to an agreed upon services plan. Under the 2013 AZ Agreements, AstraZeneca could have requested we provide additional services, at AstraZeneca’s expense. Subject to customary “back-up” supply rights granted to AstraZeneca, we exclusively manufactured (or had manufactured) mRNA for all research, development and commercialization purposes under the 2013 AZ Agreements until, on a product-by-product basis, the expiration of the time period for which we are entitled to receive earn-out payments with respect to such product pursuant to the 2013 AZ Agreements. As of the effective date of the 2013 AZ Agreements, AstraZeneca acquired forty options that it may exercise to obtain exclusive rights to clinically develop and commercialize identified development candidates (and related back-up candidates) directed to specified targets that arise during the research and evaluation period. During the research and evaluation period for research candidates under the 2013 AZ Agreements, AstraZeneca could have elected to designate a limited number of research candidates as development candidates in order to continue preclinical development on such development candidates (and related back-up candidates). From such pool of development candidates designated by AstraZeneca, during a specified option exercise period, AstraZeneca could have then exercised one of its options to obtain exclusive rights to clinically develop and commercialize an identified development candidate (and related back-up candidates). If AstraZeneca did not exercise one of its options to acquire exclusive rights to clinically develop and commercialize a particular development candidate during the defined option exercise period for such development candidate, AstraZeneca’s rights to exercise an option and other rights granted under the 2013 AZ Agreements with respect to such development candidate (and related back-up candidates) would terminate, all rights to exploit such development candidate (and related back-up candidates) would be returned to us and all data and results generated by AstraZeneca with respect to such development candidate (and related back-up candidates) would be either assigned or licensed to us. Upon the earlier of termination of the 2013 AZ Agreements for any reason and a specified anniversary of the effective date of the 2013 AZ Agreements, all unexercised options, and the right to exercise any and all options if not previously exercised by AstraZeneca, would automatically terminate. On a target-by-target basis, we and AstraZeneca agreed to certain defined exclusivity obligations under the 2013 AZ Agreements with respect to the research, development and commercialization of mRNA medicines for such target. As of the effective date of the 2013 AZ Agreements, AstraZeneca made upfront cash payments to us totaling $240.0 million . Under the 2013 AZ Agreements, we were entitled to receive payments that are not related to any specific program of up to $180.0 million in the aggregate for the achievement of three technical milestones relating to toxicity, delivery, and competition criteria. We achieved the toxicity and competition milestones in the year ended December 31, 2015. The delivery milestone has expired. Under the 2013 AZ Agreements, AstraZeneca was obligated to pay us a $10.0 million option exercise fee with respect to each development candidate (and related back-up candidates) for which it exercised an option. In addition, upon AstraZeneca’s exercise of each option, we were eligible to receive certain payments contingent upon the achievement of specified clinical, regulatory, and commercial events. For any product candidate optioned by AstraZeneca, we were eligible to receive, per product candidate, up to $100.0 million in payments for achievement of development milestones, up to $100.0 million payments for achievement of regulatory milestones, and up to $200.0 million payments for achievement of commercial milestones. Additionally, under the 2013 AZ Agreements, we were entitled to receive, on a product-by-product basis, earn-out payments on worldwide net sales of products ranging from a high-single digit percentage to 12% , subject to certain reductions, with an aggregate minimum floor. We received from AstraZeneca under the 2013 AZ Agreements an option exercise payment of $10.0 million in the year ended December 31, 2016, and a clinical milestone payment of $30.0 million with respect to AstraZeneca’s VEGF-A product (AZD8601) during the year ended December 31, 2018, that is currently being developed in a Phase 2 clinical trial in certain fields. Unless earlier terminated, the 2013 AZ Agreements would have continued until the expiration of AstraZeneca’s earn-out and contingent option exercise payment obligations for optioned product candidates. Either party had the right to terminate the 2013 AZ Agreements upon the other party’s material breach, either in its entirety or in certain circumstances, with respect to relevant candidates, subject to a defined materiality threshold and specified notice and cure provisions. If AstraZeneca had the right to terminate the 2013 AZ Agreements for our material breach, then AstraZeneca could have elected, in lieu of terminating the 2013 AZ Agreements, in their entirety or with respect to such candidates, to have the 2013 AZ Agreements remain in effect, subject to reductions in certain payments we were eligible to receive and certain adjustments to AstraZeneca’s obligations under the 2013 AZ Agreements. AstraZeneca had the right to terminate the 2013 AZ Agreements in full, without cause, upon 90 -days’ prior notice to us. 2016 Strategic Alliance with AstraZeneca – IL12 In January 2016, we entered into a new Strategic Drug Development Collaboration and License Agreement, which we refer to as the 2016 AZ Agreement, with AstraZeneca to discover, develop and commercialize potential mRNA medicines for the treatment of a range of cancers. Under the terms of the 2016 AZ Agreement, we and AstraZeneca have agreed to work together on an immuno-oncology program focused on the intratumoral delivery of a potential mRNA medicine to make the IL12 protein. The 2016 AZ Agreement initially included research activities with respect to a second discovery program. During a limited period of time, each party had an opportunity to propose additional discovery programs to be conducted under the 2016 AZ Agreement. We are responsible for conducting and funding all discovery and preclinical development activities under the 2016 AZ Agreement in accordance with an agreed upon discovery program plan for the IL12 program and any other discovery program the parties agree to conduct under the 2016 AZ Agreement. For the IL12 program and any other discovery program the parties agree to conduct under the 2016 AZ Agreement, during a defined election period that commenced as of the effective date of the 2016 AZ Agreement (for the IL12 program) and otherwise will commence on initiation of any such new discovery program, AstraZeneca may elect to participate in the clinical development of a development candidate arising under the 2016 AZ Agreement from such program. If AstraZeneca so elects (as it has for the IL12 program), AstraZeneca will lead clinical development activities worldwide and we will be responsible for certain activities, including being solely responsible for manufacturing activities, all in accordance with an agreed upon development plan. AstraZeneca will be responsible for funding all Phase 1 clinical development activities (including costs associated with our manufacture of clinical materials in accordance with the development plan), and Phase 2 clinical development activities (including costs associated with our manufacture of clinical materials in accordance with the development plan) up to a defined dollar threshold. We and AstraZeneca will equally share the costs of Phase 2 clinical development activities in excess of such dollar threshold, all Phase 3 clinical development activities and certain other costs of late-stage clinical development activities, unless we elect not to participate in further development and commercialization activities and instead receive tiered royalties, as described below. We and AstraZeneca will co-commercialize products in the U.S. in accordance with an agreed upon commercialization plan and budget, and on a product-by-product basis will equally share the U.S. profits or losses arising from such commercialization. Notwithstanding, on a product-by-product basis, prior to a specified stage of development of a given product, we have the right to elect not to participate in the further development and commercialization activities for such product. If we make such election, instead of participating in the U.S. profits and losses share with respect to such product, we are obligated to discuss future financial terms with AstraZeneca. If we are unable to agree on future financial terms within a short, defined period of time, we are entitled to receive tiered royalties at default rates set forth in the 2016 AZ Agreement, ranging from percentages in the mid-single digits to 20% on worldwide net sales of products, subject to certain reductions with an aggregate minimum floor. AstraZeneca has sole and exclusive responsibility for all ex-U.S. commercialization efforts. Unless we have elected to not to participate in further development (in which case royalties on ex-U.S. net sales will be at the default rates as described above, unless otherwise agreed by the parties), we are entitled to tiered royalties at rates ranging from 10% to 30% on ex-U.S. net sales of the products, subject to certain reductions with an aggregate minimum floor. Subject to customary “back-up” supply rights granted to AstraZeneca, we exclusively manufacture (or have manufactured) products for all development and commercialization purposes. We and AstraZeneca have agreed to certain defined exclusivity obligations with each other under the 2016 AZ Agreement with respect to the development and commercialization of mRNA medicines for IL12. Unless earlier terminated, our strategic alliance under the 2016 AZ Agreement will continue on a product-by-product basis (i) until both parties cease developing and commercializing such product without the intention to resume, if we have not elected our right not to participate in further development and commercialization of such product or (ii) on a country-by-country basis, until the end of the applicable royalty term for such product in such country, if we have elected our right not to participate in further development and commercialization of such product. Either party may terminate the 2016 AZ Agreement upon the other party’s material breach, subject to specified notice and cure provisions. Each party may also terminate the 2016 AZ Agreement in the event the other party challenges such party’s patent rights, subject to certain defined exceptions. AstraZeneca has the right to terminate the 2016 AZ Agreement in full or with respect to any program for scientific, technical, regulatory or commercial reasons at any time upon 90 days’ prior written notice to us. On a product-by-product basis, we have the right to terminate the 2016 AZ Agreement in certain cases if AstraZeneca has suspended or is no longer proceeding with the development or commercialization of such product for a period of twelve consecutive months, subject to specified exceptions, including tolling for events outside of AstraZeneca’s control. On a product-by-product basis, if the 2016 AZ Agreement is terminated with respect to a given product, AstraZeneca’s rights in such product will terminate and, to the extent we terminated for AstraZeneca’s breach, patent challenge or cessation of development or AstraZeneca terminated in its discretion, AstraZeneca will grant us reversion licenses and take certain other actions so as to enable us to continue developing and commercializing such product in the oncology field. If we continue developing and commercializing a given product following termination of the 2016 AZ Agreement by AstraZeneca in its discretion with respect to such product, AstraZeneca is entitled to receive a mid-single digit royalty on our worldwide net sales of such product and a high-single digit percentage of the amounts received by us from a third party in consideration of a license to such third party to exploit such product, in each case, until AstraZeneca recovers an amount equal to specified development costs incurred by AstraZeneca under the 2016 AZ Agreement with respect to such product prior to such termination. Such percentages increase by a low to mid-single digit amount to the extent such termination occurs after such product achieves a specified stage of development. 2017 Strategic Alliance with AstraZeneca – Relaxin In October 2017, we entered a new Collaboration and License Agreement, which we refer to as the 2017 AZ Agreement, under which AstraZeneca may clinically develop and commercialize a development candidate, now known as AZD7970, which is comprised of an mRNA construct for the relaxin protein designed by us and encapsulated in one of our proprietary lipid nanoparticles ("LNP"). We discovered and performed preclinical development activities for AZD7970 prior to the initiation of the strategic alliance with AstraZeneca under the 2017 AZ Agreement. Under the terms of the 2017 AZ Agreement, we will fund and be responsible for conducting preclinical development activities for AZD7970 through completion of IND-enabling GLP toxicology studies and AstraZeneca will lead pharmacological studies, each in accordance with an agreed upon discovery program plan. During a defined election period that commences as of the effective date of the 2017 AZ Agreement, AstraZeneca may elect to participate in further development and commercialization of AZD7970. Upon such election, AstraZeneca will lead clinical development activities for AZD7970 worldwide and we will be responsible for manufacturing AZD7970, certain regulatory matters and any other development activities that we agree to perform and that are set forth in an agreed upon development plan. AstraZeneca will be responsible for funding Phase 1 clinical development activities (including costs associated with our manufacture of clinical materials in accordance with the development plan, up to a cap above which such costs are shared), and Phase 2 clinical development activities (including costs associated with our manufacture of clinical materials in accordance with the development plan, up to a cap above which such costs are shared) up to a defined dollar threshold. Thereafter, we and AstraZeneca will equally share the costs of Phase 2 clinical development activities in excess of such defined dollar threshold, all Phase 3 clinical development activities and certain other costs of late-stage clinical development activities, unless we elect not to participate in further development and co-commercialization activities and instead receive tiered royalties as described below. If the development candidate is determined to be IND-ready, and AstraZeneca does not timely elect to participate in the clinical development of AZD7970, AstraZeneca is obligated to reimburse us for certain costs we incurred in the manufacture and development of AZD7970, since execution of the 2017 AZ Agreement. We and AstraZeneca will co-commercialize AZD7970 in the United States in accordance with an agreed upon commercialization plan and budget, and will equally share U.S. profits or losses arising from such commercialization. Notwithstanding, prior to a specified stage of development of AZD7970, we have the right to elect not to participate in the further development and commercialization activities for AZD7970. If we make such election, instead of participating in the U.S. profits and losses share with respect to AZD7970, we are obligated to discuss future financial terms with AstraZeneca. If we are unable to agree on future financial terms within a short, defined period of time, we are entitled to receive tiered royalties at default rates set forth in the 2017 AZ Agreement, ranging from percentages in the mid-single digits to the low 20s on worldwide net sales by AstraZeneca of AZD7970, subject to certain reductions, with an aggregate minimum floor. AstraZeneca has sole and exclusive responsibility for all ex-U.S. commercialization efforts. Unless we have elected not to participate in further development (in which case royalties on ex-U.S. net sales will be at the default rates as described above, unless otherwise agreed by the parties), we are entitled to receive tiered royalties at rates ranging from 10% to 30% on annual ex-U.S. net sales of AZD7970, subject to certain reductions with an aggregate minimum floor. Subject to customary “back-up” supply rights granted to AstraZeneca, we exclusively manufacture (or have manufactured) products for all development and commercialization purposes. Additionally, we and AstraZeneca have agreed to certain defined exclusivity obligations under the 2017 AZ Agreement with respect to the development and commercialization of mRNA medicines for Relaxin. Unless earlier terminated, our strategic alliance under the 2017 AZ Agreement will continue (i) until the expiration of AstraZeneca’s election period, if it does not elect to participate in the clinical development of AZD7970, (ii) until both parties cease developing and commercializing AZD7970 without the intention to resume, if we have not elected our right not to participate in further development and commercialization of AZD7970, (iii) on a country-by-country basis, until the end of the applicable royalty term for AZD7970 in such country, if we have elected our right not to participate in further development and commercialization of AZD7970 or (iv) following completion of IND-enabling studies with respect to AZD7970, if we provide AstraZeneca with written notice that we do not reasonably believe that the product is IND-ready. Either party may terminate the 2017 AZ Agreement upon the other party’s material breach, subject to specified notice and cure provisions. Each party may also terminate the 2017 AZ Agreement in the event the other party challenges the validity or enforceability of such party’s patent rights, subject to certain defined exceptions. AstraZeneca has the right to terminate the 2017 AZ Agreement in full for scientific, technical, regulatory or commercial reasons at any time upon 90 days’ prior written notice to us. We have the right to terminate the 2017 AZ Agreement in certain cases if AstraZeneca has suspended or is no longer proceeding with the development or commercialization of AZD7970 for a period of twelve consecutive months, subject to specified exceptions, including tolling for events outside of AstraZeneca’s control. If AstraZeneca does not timely elect to participate in clinical development of AZD7970, or the Agreement is terminated, AstraZeneca’s rights in AZD7970 will terminate and, to the extent we terminated for AstraZeneca’s breach, patent challenge or cessation of development or AstraZeneca terminated in its discretion, AstraZeneca will grant us reversion licenses and take certain other actions so as to enable us to continue developing and commercializing AZD7970 in the cardiovascular and cardiometabolic fields. If we continue developing and commercializing AZD7970 following a termination of the 2017 AZ Agreement by AstraZeneca in its discretion, AstraZeneca is entitled to receive a mid-single digit royalty on our worldwide net sales of AZD7970 and a high-single digit percentage of the amounts received by us from a third party in consideration for a license to such third party to exploit AZD7970, in each case until AstraZeneca recovers an amount equal to specified development costs incurred by AstraZeneca under the 2017 AZ Agreement with respect to AZD7970 prior to such termination. Such percentages increase by a low to mid-single digit amount to the extent such termination occurs after such product achieves a specified stage of development. 2013 Agreements with AstraZeneca, amended and restated in 2018 In June 2018, we entered into an Amended and Restated Option Agreement and a related Amended and Restated Services and Collaboration Agreement with AstraZeneca, or the 2018 A&R Agreements, which amended and restated the 2013 AZ Agreements. Under the 2018 A&R Agreements, we granted AstraZeneca certain exclusive rights and licenses to research, develop and commercialize potential therapeutic mRNA medicines directed at certain targets for the treatment of cardiovascular and cardiometabolic diseases and cancer, and agreed to provide related services to AstraZeneca. The activities to be performed by the parties under the 2018 A&R Agreements are limited to defined biological targets in the cardiovascular and cardiometabolic fields and one defined target in the cancer field. Pursuant to the 2018 A&R Agreements, AstraZeneca is responsible for all research, development and commercialization activities and associated costs, while we provide specified research and manufacturing services during a research and evaluation period, as described below, to further AstraZeneca’s activities conducted pursuant to an agreed upon services plan. During this research and evaluation period, these research services, and manufacturing services in excess of a specified threshold, are provided at AstraZeneca’s expense, and manufacturing services below the specified threshold are provided at no additional expense to AstraZeneca. AstraZeneca may request we provide additional research and manufacturing services, at AstraZeneca’s expense, following the end of the research and evaluation period. Subject to customary “back-up” supply rights granted to AstraZeneca, we exclusively manufacture (or have manufactured) mRNA for all research, development and commercialization purposes under the 2018 A&R Agreements until, on a product-by-product basis, the expiration of the time period for which we are entitled to receive earn-out payments with respect to such product pursuant to the 2018 A&R Agreements. As of the effective date of the 2013 AZ Agreements, and as further reflected in the 2018 A&R Agreements, AstraZeneca acquired forty options that it may exercise to obtain exclusive rights to clinically develop and commercialize identified development candidates (and related back-up candidates) directed to specified targets that arise during the research and evaluation period. During the research and evaluation period for research candidates, AstraZeneca may elect to designate a limited number of research candidates as development candidates in order to continue preclinical development on such development candidates (and related back-up candidates). From such pool of development candidates designated by AstraZeneca, during a specified option exercise period, AstraZeneca may then exercise one of its options to obtain exclusive rights to clinically develop and commercialize an identified development candidate (and related back-up candidates) in certain fields. If AstraZeneca does not exercise one of its options to acquire exclusive rights to clinically develop and commercialize a particular development candidate during the defined option exercise period for such development candidate, AstraZeneca’s rights to exercise an option and other rights granted under the 2018 A&R Agreements with respect to such development candidate (and related back-up candidates) will terminate, all rights to exploit such development candidate (and related back-up candidates) will be returned to us and all data and results generated by AstraZeneca with respect to such development candidate (and related back-up candidates) will be either assigned or licensed to us. Upon the earlier of termination of the 2018 A&R Agreements for any reason and a specified anniversary of the effective date of the 2013 AZ Agreements, all unexercised options, and the right to exercise any and all options if not previously exercised by AstraZeneca, will automatically terminate. On a target-by-target basis, we and AstraZeneca have agreed to certain defined exclusivity obligations under the 2018 A&R Agreements with respect to the research, development and commercialization of mRNA medicines for such target in certain fields. In addition, we and AstraZeneca have agreed to certain defined exclusivity obligations with respect to the research, development and commercialization of mRNA medicines coding for the same polypeptide as any development candidate being developed under the 2018 A&R Agreements. Unless earlier terminated, the 2018 A&R Agreements will continue until the expiration of AstraZeneca’s earn-out and contingent option exercise payment obligations for optioned product candidates. Either party may terminate the 2018 A&R Agreements upon the other party’s material breach, either in its entirety or in certain circumstances, with respect to relevant candidates, subject to a defined materiality threshold and specified notice and cure provisions. If AstraZeneca has the right to terminate the 2018 A&R Agreements for our material breach, then AstraZeneca may elect, in lieu of terminating the 2018 A&R Agreements, in their entirety or with respect to such candidates, to have the 2018 A&R Agreements remain in effect, subject to reductions in certain payments we are eligible to receive and certain adjustments to AstraZeneca’s obligations under the 2018 A&R Agreements. AstraZeneca may terminate the 2018 A&R Agreements in full, without cause, upon 90 days’ prior notice to us. Accounting Treatment For periods prior to January 1, 2019, we applied the provisions of ASC 605 in accounting for these arrangements, except for the 2017 AZ Agreement which was accounted for under ASC 808. In August 2016, AstraZeneca exercised a product option available pursuant to the 2013 AZ Agreements to obtain exclusive rights to clinically develop and commercialize the VEGF-A product (AZD8601). This option exercise is referred to as the 2016 VEGF Exercise. Consistent with our conclusions under ASC 605 and pursuant to ASC 606, we determined that the 2016 VEGF Exercise and the 2017 AZ Agreement should be accounted for as separate transactions as the agreements are not interrelated or interdependent. Conversely, the 2013 Agreements, as amended by the 2018 A&R Agreements, and the 2016 AZ Agreement, were combined for accounting purposes and treated as a single agreement, as these agreements were negotiated in contemplation of each other. As of the date of our initial application of ASC 606, we applied the practical expedient to include the aggregate effect of all modifications to the arrangement that occurred before January 1, 2019 with respect to (i) identification of the satisfied and unsatisfied performance obligations, (ii) determination of the transaction price and (iii) allocation of the transaction price to the satisfied and unsatisfied performance obligations. Therefore, we aggregated effects of all the modifications prior to January 1, 2019 to the 2013 Agreements, including the effects of the 2018 A&R Agreements, and the 2016 AZ Agreement were combined into one transaction for accounting purposes. We will refer to this combined transaction as the Combined 2018 AZ Agreements. We determined that all aspects of Combined 2018 AZ Agreements and the 2016 VEGF Exercise represent a transaction with a customer and therefore is accounted for in accordance with ASC 606 as of the date of the initial application. Combined 2018 AZ Agreements We identified the following performance obligations in the Combined 2018 AZ Agreements: (i) a combined performance obligation that includes a research license, research and development pool services, and manufacturing obligations related to the 2013 AZ Agreements, as amended by the 2018 A&R Agreements, collectively referred to as the Combined 2018 AZ Agreement Performance Obligation, (ii) preclinical development services for IL12, (iii) preclinical development services for an oncology development target, (iv) a combined performance obligation for a development and commercialization license and manufacturing obligations for IL12, and (v) a material right to receive development and commercialization rights and manufacturing services for an oncology development target. We concluded that the research license is not distinct from the research and development pool services or the manufacturing obligations related to the 2018 A&R Agreements, as AstraZeneca cannot fully exploit the value of the research license without receipt of such services and supply. Our services and supply involve specialized expertise, particularly as it relates to mRNA technology that is not available in the marketplace. Any supply requested by AstraZeneca in excess of the minimum quantities specified in the agreement are considered customer options and treated as separate contracts for accounting purposes. Further, we concluded that AstraZeneca cannot exploit the value of the development and commercialization license for IL12 without receipt of supply as the development and commercialization license does not convey to AstraZeneca the right to manufacture and therefore combined the development and commercialization license and the manufacturi |
Grants
Grants | 6 Months Ended |
Jun. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Grants | Grants Biomedical Advanced Research and Development Authority (BARDA) In September 2016, we received an award of up to $125.8 million under Agreement No. HHSO100201600029C from BARDA, a component of the Office of the Assistant Secretary for Preparedness and Response, or ASPR within the U.S. Department of Health and Human Services, or HHS, to help fund our Zika vaccine program. Under the terms of the agreement with BARDA, an initial base award of $8.2 million supported toxicology studies, a Phase 1 clinical trial, and associated manufacturing activities. Contract options were available, for $117.6 million to support an additional Phase 1 study of an improved Zika vaccine candidate, Phase 2 and Phase 3 clinical studies, as well as large-scale manufacturing for the Zika vaccine. As of June 30, 2019 , three of the four contract options had been exercised resulting in $117.3 million of available funding with an additional $8.5 million available if the final contract option is exercised. For the three months ended June 30, 2019 and 2018 , we recognized revenue of $1.9 million and $1.6 million , respectively, relating to the BARDA agreement. For the six months ended June 30, 2019 and 2018 , we recognized revenue of $3.4 million and $2.6 million , respectively, relating to the BARDA agreement. The Bill & Melinda Gates Foundation (Gates Foundation) In January 2016, we entered a global health project framework agreement with the Gates Foundation to advance mRNA-based development projects for various infectious diseases. The Gates Foundation has committed up to $20.0 million in grant funding to support our initial project related to the evaluation of antibody combinations in a preclinical setting as well as the conduct of a first-in-human Phase 1 clinical trial of a potential mRNA medicine to help prevent human immunodeficiency virus, or HIV, infections. Follow-on projects which could bring total potential funding under the framework agreement up to $100.0 million (including the HIV antibody project) to support the development of additional mRNA-based projects for various infectious diseases can be proposed and approved until the sixth anniversary of the framework agreement, subject to the terms of the framework agreement, including our obligation to grant to the Gates Foundation certain non-exclusive licenses. In March 2019, the Gates Foundation provided an additional funding commitment up to $1.1 million to support a follow-on project. As of June 30, 2019 , up to $21.1 million has been committed for funding with up to an additional $80 million available, if additional follow-on projects are approved. For the three months ended June 30, 2019 and 2018 , we recognized $1.0 million and $0.1 million , respectively, relating to the Gates Foundation agreement. For the six months ended June 30, 2019 and 2018 , we recognized revenue of $1.3 million and $0.4 million , respectively, relating to the Gates Foundation agreement. We had deferred revenue of $3.7 million and $0.8 million as of June 30, 2019 and December 31, 2018 , respectively, related to the Gates Foundation agreement. Defense Advanced Research Projects Agency (DARPA) In October 2013, DARPA awarded us up to $24.6 million under Agreement No. W911NF-13-1-0417, which was subsequently adjusted to $19.7 million , to research and develop potential mRNA medicines as a part of DARPA’s Autonomous Diagnostics to Enable Prevention and Therapeutics, or ADEPT, program, which is focused on assisting with the development of technologies to rapidly identify and respond to threats posed by natural and engineered diseases and toxins. The DARPA awards have been deployed primarily in support of our vaccine and antibody programs to protect against chikungunya infection. As of June 30, 2019 and December 31, 2018 , $19.7 million has been committed by DARPA. There was no revenue recognized for the three or six months ended June 30, 2019 , related to the DARPA agreement. We recognized revenue of $1.3 million and $1.5 million for the three and six months ended June 30, 2018 , respectively, related to the DARPA agreement. |
Financial Instruments
Financial Instruments | 6 Months Ended |
Jun. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Financial Instruments | Financial Instruments Cash and Cash Equivalents and Investments The following tables summarize our cash and available-for-sale securities by significant investment category at June 30, 2019 and December 31, 2018 (in thousands): June 30, 2019 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Current Marketable Securities Non- Current Marketable Securities Cash and cash equivalents $ 151,624 $ — $ — $ 151,624 $ 151,624 $ — $ — Available-for-sale: Level 2: Certificates of deposit 136,011 160 (1 ) 136,170 — 132,469 3,701 U.S. treasury securities 153,651 507 — 154,158 — 129,985 24,173 Debt securities of U.S. government agencies and corporate entities 990,203 3,275 (52 ) 993,426 — 656,268 337,158 $ 1,431,489 $ 3,942 $ (53 ) $ 1,435,378 $ 151,624 $ 918,722 $ 365,032 December 31, 2018 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Current Marketable Securities Non- Current Marketable Securities Cash and cash equivalents $ 658,365 $ 20 $ (21 ) $ 658,364 $ 658,364 $ — $ — Available-for-sale: Level 2: Certificates of deposit 173,102 42 (36 ) 173,108 — 157,920 15,188 U.S. treasury securities 152,205 18 (48 ) 152,175 — 152,175 — Debt securities of U.S. government agencies and corporate entities 712,065 40 (1,335 ) 710,770 — 552,968 157,802 $ 1,695,737 $ 120 $ (1,440 ) $ 1,694,417 $ 658,364 $ 863,063 $ 172,990 The amortized cost and estimated fair value of marketable securities by contractual maturity at June 30, 2019 are as follows (in thousands): June 30, 2019 Amortized Cost Estimated Fair Value Due in one year or less $ 916,905 $ 918,722 Due after one year through five years 362,960 365,032 Total $ 1,279,865 $ 1,283,754 At June 30, 2019 , we held 11 available-for-sale securities, or an estimated fair value of $36.5 million , out of our total investment portfolio that were in a continuous unrealized loss position for more than 12 months with a gross unrealized loss of $0.1 million . At December 31, 2018, we held 25 available-for-sale securities, or an estimated fair value of $82.8 million , out of our total investment portfolio that were in a continuous unrealized loss position for more than 12 months with a gross unrealized loss of $0.4 million . We concluded that the net declines in market value of our available-for-sale securities investment portfolio were temporary in nature and did not consider any of our investments to be other-than-temporarily impaired. In accordance with our investment policy, we place investments in investment grade securities with high credit quality issuers, and generally limit the amount of credit exposure to any one issuer. We evaluate securities for other-than-temporary impairment at the end of each reporting period. Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation. Factors considered include the length of time and extent to which fair value has been less than the cost basis, the financial condition and near-term prospects of the issuer, and our intent and ability to hold the investment to allow for an anticipated recovery in fair value. Furthermore, the aggregate of individual unrealized losses that had been outstanding for 12 months or less was not significant as of June 30, 2019 and December 31, 2018 . We neither intend to sell these investments nor conclude that we are more-likely-than-not that we will have to sell them before recovery of their carrying values. We also believe that we will be able to collect both principal and interest amounts due to us at maturity. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | Balance Sheet Components Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets, as of June 30, 2019 and December 31, 2018 consists of the following (in thousands): June 30, December 31, 2019 2018 Prepaid expenses $ 9,138 $ 10,401 Tenant incentives receivables 6,310 10,089 Interest receivable on marketable securities 7,044 7,909 Prepaid expenses and other current assets $ 22,492 $ 28,399 Property and Equipment, Net Property and equipment, net, as of June 30, 2019 and December 31, 2018 consists of the following (in thousands): June 30, December 31, 2019 2018 Building $ 140,442 $ 140,442 Laboratory equipment 102,006 96,907 Leasehold improvements 13,632 13,741 Furniture, fixtures and other 2,142 2,122 Computer equipment and software 11,665 11,513 Internally developed software 7,020 7,020 Construction in progress 10,829 4,688 287,736 276,433 Less: Accumulated depreciation (79,227 ) (64,456 ) Property and equipment, net $ 208,509 $ 211,977 Depreciation and amortization expense for the three months ended June 30, 2019 and 2018 was $7.5 million and $5.9 million , respectively. Depreciation and amortization expense for the six months ended June 30, 2019 and 2018 was $14.8 million and $11.0 million , respectively. Accrued Liabilities Accrued liabilities, as of June 30, 2019 and December 31, 2018 consists of the following (in thousands): June 30, December 31, 2019 2018 In-licenses $ — $ 22,000 Property and equipment 5,402 12,089 Compensation-related 16,001 23,406 External goods and services 23,186 21,578 Accrued liabilities $ 44,589 $ 79,073 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Lease Obligations We have entered into various long-term non-cancelable operating lease arrangements for our facilities and equipment expiring at various times through 2032. Certain of these arrangements have free rent periods or escalating rent payment provisions, which we recognize rent expense under such arrangements on a straight-line basis over the life of the leases. We have two campuses in Massachusetts. We occupy a multi-building campus in Technology Square in Cambridge, MA with a mix of offices and research laboratory space totaling approximately 200,000 square feet. Our Cambridge facility leases have expiry ranges from 2020 to 2027. We have approximately 200,000 square feet of a manufacturing facility in Norwood, MA. This facility is leased through 2032 with options for two extension periods of ten years . In February 2019, we entered into a new lease agreement for office and laboratory space of approximately 200,000 square feet, located in Norwood, MA. The lease commenced in the second quarter of 2019, and expires in early 2031. We have the option to extend the lease for up to four additional five -year terms. Contemporaneously, we entered into an agreement to sublease approximately 64 percent of the leased space to a third party. We have no rent obligations to the landlord for the space occupied by the third party. All sublease payments from the third party are paid directly to the landlord. The sublease can expire between May 2020 and February 2021 at the third party's option. Total rent expense for the three months ended June 30, 2019 and 2018 was $5.4 million and $4.8 million , respectively. Total rent expense for the six months ended June 30, 2019 and 2018 was $10.2 million and $10.0 million , respectively. Future minimum lease payments under non-cancelable operating lease agreements at June 30, 2019 , are as follows (in thousands): Fiscal Year Minimum Lease Payments 2019 (remainder of the year) $ 10,206 2020 22,481 2021 24,253 2022 23,697 2023 20,586 Thereafter 137,948 Total $ 239,171 Strategic Collaborations Under our strategic collaboration agreements, we are committed to perform certain research, development, and manufacturing activities. As part of our PCV Agreement and PCV/SAV Agreement with Merck, we are committed to perform certain research, development and manufacturing activities related to PCV products through an initial Phase 2 clinical trial up to a budgeted amount of $243.0 million for both periods as of June 30, 2019 and December 31, 2018 (see Note 3). Purchase Commitments and Purchase Orders We have agreements with third parties for various services, including manufacturing and services related clinical operations and support, for which we are not contractually able to terminate for convenience and avoid any and all future obligations to these vendors. Certain agreements provide for termination rights subject to termination fees or wind down costs. Under such agreements, we are contractually obligated to make certain payments to vendors, mainly, to reimburse them for their unrecoverable outlays incurred prior to cancellation. At June 30, 2019 and December 31, 2018 , we had cancelable open purchase orders of $83.9 million and $64.2 million , respectively, in total under such agreements for our significant clinical operations and support. These amounts represent only our estimate of those items for which we had a contractual commitment to pay at June 30, 2019 and December 31, 2018 , assuming we would not cancel these agreements. The actual amounts we pay in the future to the vendors under such agreements may differ from the purchase order amounts. Legal Proceedings We are not currently a party to any material legal proceedings. |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders' Equity On February 28, 2018 and May 7, 2018, the Board of Directors approved an amendment to our Certificate of Incorporation resulting in a total of 775,000,000 shares of common stock and a total of 509,352,795 shares of redeemable convertible preferred stock being authorized, respectively. Upon completion of our IPO, our authorized capital stock consists of 1,600,000,000 shares of common stock, par value $0.0001 per share, and 162,000,000 shares of preferred stock, par value $0.0001 per share, all of which shares of preferred stock are undesignated. On December 11, 2018, we completed our IPO, whereby we sold 26,275,993 shares of common stock at a price of $23.00 per share. The aggregate net proceeds received by us from the IPO were $563.0 million , net of underwriting discounts and commissions of $33.2 million and offering expenses of $8.1 million payable by us. Upon the closing of the IPO, all of the outstanding shares of our redeemable convertible preferred stock were converted into 236,012,913 shares of the common stock. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Equity Plans In connection with the IPO, we adopted our 2018 Stock Option and Incentive Plan (the 2018 Equity Plan) in November 2018. The 2018 Equity Plan became effective on the date immediately prior to the effective date of the IPO and replaced our 2016 Stock Option and Grant Plan (the 2016 Equity Plan). On January 1, 2019, the number of shares of common stock available for issuance under the 2018 Equity Plan increased by 13.2 million shares as a result of the automatic increase provision of the 2018 Equity Plan. As of June 30, 2019 , we had a total of 71.3 million shares reserved for future issuance under our Equity Plans, of which 18.1 million shares were available for future grants. Options We have granted options generally through the 2018 Equity Plan and 2016 Equity Plan. The following table summarizes our option activity as of June 30, 2019 : Number of Options Weighted- Average Exercise Price per Share Weighted- Average Grant Date Fair Value per Share Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value (1) (in thousands) Outstanding at December 31, 2018 50,821,132 $ 12.16 $ 6.59 7.1 years $ 220,434 Granted 6,280,966 20.24 11.87 Exercised (1,051,793 ) 3.86 3.89 Canceled/forfeited (4,067,618 ) 14.57 8.69 Outstanding at June 30, 2019 51,982,687 13.14 7.05 7.2 years 181,371 Exercisable at June 30, 2019 25,559,777 9.10 4.34 5.5 years 161,093 Vested and expected to vest at June 30, 2019 26,422,410 17.04 9.68 8.9 years 20,278 _______ (1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of common stock for those options in the money as of June 30, 2019 . For the six months ended June 30, 2019 , 1.1 million stock options were exercised. The total intrinsic value of options exercised was $14.8 million for the six months ended June 30, 2019. The aggregate intrinsic value represents the difference between the exercise price and the selling price received by option holders upon the exercise of stock options during the period. The total consideration recorded as a result of stock option exercises was approximately $4.1 million for the six months ended June 30, 2019 . Restricted Common Stock We have granted restricted stock awards generally through the 2016 Equity Plan. The following table summarizes our restricted stock activity for the six months ended June 30, 2019 : Number of Weighted Average Fair Value per Share Outstanding, non-vested at December 31, 2018 198,597 $ 12.15 Issued — — Vested (107,475 ) 12.15 Canceled, forfeited and adjustments, net (314 ) 12.15 Outstanding, non-vested at June 30, 2019 90,808 12.15 Restricted Common Stock Units We have granted restricted stock awards generally through the 2018 Equity Plan and 2016 Equity Plan. The following table summarizes our restricted stock unit activity during the six months ended June 30, 2019 : Units Weighted-Average per Unit Outstanding, non-vested at December 31, 2018 458,715 $ 11.93 Issued 636,808 20.93 Vested (1) 28,668 11.93 Canceled/forfeited (21,629 ) 20.93 Pending settlement (1) (28,668 ) 11.93 Outstanding, non-vested at June 30, 2019 1,073,894 17.08 _________ (1) The vested restricted stock units will be settled for common stock on the date which is 360 days after the consummation of the IPO. 2018 Employee Stock Purchase Plan In November 2018, we adopted our 2018 Employee Stock Purchase Plan (ESPP), which became effective on December 5, 2018. The ESPP initially reserves and authorizes the issuance of up to a total of 810,000 shares of common stock to participating employees. Our ESPP has a six -month offering period, with a new period commencing on the first business day on or after June 1 and December 1 of each year. The purchase price at which shares are sold under the ESPP will be equal to 85% of the lower of the fair market value of the shares on the first business day of the offering period or the last business day of the purchase period. Employees are generally eligible to participate through payroll deductions of between 1% to 50% of their compensation and may not purchase more than 3,000 shares of common stock during each purchase period or $25,000 worth of shares of common stock in any calendar year. We began our first ESPP offering on June 1, 2019. There were no shares sold under the ESPP during the six months ended June 30, 2019 . Valuation and Stock-Based Compensation Expense Stock-based compensation for options granted under our Equity Plans and share purchases under our ESPP is determined using the Black-Scholes option pricing model. The weighted-average assumptions used to estimate the fair value of options granted and ESPP for the six months ended June 30, 2019 and 2018 are as follows: Weighted Average Six Months Ended June 30, 2019 2018 Options: Risk-free interest rate 2.42 % 2.71 % Expected term 6.07 years 6.06 years Expected volatility 62 % 64 % Expected dividends — % — % Weighted average fair value per share $ 11.87 $ 8.63 ESPP: Risk-free interest rate 2.31 % Expected term 0.50 years Expected volatility 50 % Expected dividends — % Weighted average fair value per share 19.85 The following table presents the components and classification of stock-based compensation expense for the three and six months ended June 30, 2019 and 2018 as follows (in thousands): Three Months Ended Six Months Ended June 30, 2019 2018 2019 2018 Options $ 19,994 $ 13,263 $ 37,481 $ 23,311 Restricted common stock and units 1,327 1,090 2,337 2,893 ESPP 174 — 174 — Total $ 21,495 $ 14,353 $ 39,992 $ 26,204 Research and development $ 12,869 $ 8,428 $ 23,652 $ 15,784 General and administrative 8,626 5,925 16,340 10,420 Total $ 21,495 $ 14,353 $ 39,992 $ 26,204 As of June 30, 2019 , there was $231.7 million of total unrecognized compensation cost related to unvested stock-based compensation with respect to options and restricted stock granted. That cost is expected to be recognized over a weighted-average period of 3.36 years at June 30, 2019 . |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes We recognize deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting and tax bases of assets and liabilities. These differences are measured using the enacted statutory tax rates that are expected to be in effect for the years in which differences are expected to reverse. Valuation allowances are provided when the expected realization of deferred tax assets does not meet a “more likely than not” criterion. Realization of our deferred tax assets is dependent upon the generation of future taxable income, the amount and timing of which are uncertain. We continued to maintain a full valuation allowance against all of our deferred tax assets based on management’s evaluation of all available evidence. There were no significant income tax provisions or benefits for the three or six months ended June 30, 2019 and 2018. Upon adoption of ASC 606 (see Note 2), we recorded a cumulative-effect adjustment of $28.0 million to the opening balance of accumulated deficit as of January 1, 2019 with a decrease in deferred revenue of $30.7 million and a decrease in accounts receivable of $2.7 million . As a result of the cumulative decrease in deferred revenue, our corresponding deferred tax asset decreased by $8.4 million , which was offset by a corresponding decrease to our valuation allowance. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Net Loss per Share Net Loss per Share Attributable to Common Stockholders Basic and diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2019 and 2018 are calculated as follows (in thousands, except share and per share data): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Numerator: Net loss $ (135,054 ) $ (90,601 ) $ (267,711 ) $ (162,977 ) Cumulative dividends on redeemable convertible preferred stock — (3,481 ) — (6,962 ) Net loss attributable to common stockholders $ (135,054 ) $ (94,082 ) $ (267,711 ) $ (169,939 ) Denominator: Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted 329,176,107 65,938,939 328,994,058 65,686,290 Net loss per share attributable to common stockholders, basic and diluted $ (0.41 ) $ (1.43 ) $ (0.81 ) $ (2.59 ) The following common stock equivalents, presented based on amounts outstanding as of June 30, 2019 and 2018 were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated because their inclusion would have been anti-dilutive: June 30, 2019 2018 Redeemable convertible preferred stock — 236,120,492 Stock options 51,982,687 44,269,380 Restricted common stock 90,808 410,607 Restricted common stock units 1,073,894 458,715 53,147,389 281,259,194 |
Summary of Basis of Presentat_2
Summary of Basis of Presentation and Recent Accounting Standards (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | The accompanying unaudited condensed consolidated financial statements that accompany these notes have been prepared in conformity with U.S. generally accepted accounting principles (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting, consistent in all material respects with those applied in our Annual Report on Form 10-K for the year ended December 31, 2018 (2018 Form 10-K), except for changes associated with recent accounting standards for revenue recognition as detailed in "Note 2 - Recent Accounting Standards and Accounting Policies." This report should be read in conjunction with the consolidated financial statements in our 2018 Form 10-K. We have made estimates and judgments affecting the amounts reported in our condensed consolidated financial statements and the accompanying notes. On an ongoing basis, we evaluate our estimates, including critical accounting policies or estimates related to revenue recognition, research and development expense, income tax provisions, stock-based compensation, and useful lives of long-lived assets. We base our estimates on historical experience and on various relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. The actual results that we experience may differ materially from our estimates. The condensed consolidated financial statements reflect all normal recurring adjustments necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, but are not necessarily indicative of the results of operations to be anticipated for the full year ending December 31, 2019. |
Revenue Recognition | On January 1, 2019, we adopted Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers (ASC 606), using the modified retrospective transition method applied to those contracts which were not completed as of January 1, 2019. We recognized the cumulative effect of the adoption as an adjustment to the opening balance of accumulated deficit in the current period condensed consolidated balance sheet. Results for reporting periods beginning after January 1, 2019 are presented under ASC 606, while prior period amounts have not been adjusted and continue to be reported in accordance with our historic accounting under ASC Topic 605, Revenue Recognition (ASC 605). ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Our revenue is primarily generated through collaboration arrangements and grants from government-sponsored and private organizations. Our collaboration arrangements typically contain multiple promises, including licenses to our intellectual property, options to obtain development and commercialization rights, research and development services, and obligations to develop and manufacture preclinical and clinical material. Such arrangements provide for various types of payments to us, including upfront payments, funding of research and development activities, funding for the purchase of preclinical and clinical material, development, regulatory and commercial milestone payments, licensing fees, option exercise payments, and royalties based on product sales. We have received grants from various government-sponsored and private organizations for research and related activities that provide for payments for reimbursed costs, which may include overhead and general and administrative costs as well as a related profit margin. We analyze our collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, we assess whether aspects of the arrangement between us and our collaboration partner are within the scope of other accounting literature. If we conclude that some or all aspects of the arrangement represent a transaction with a customer, we account for those aspects of the arrangement within the scope of ASC 606 . If we conclude that some or all aspects of the arrangement are within the scope of ASC 808 and do not represent a transaction with a customer, we recognize our allocation of the shared costs incurred with respect to the jointly conducted activities as a component of the related expense in the period incurred. Pursuant to ASC 606, a customer is a party that has contracted with an entity to obtain goods or services that are an output of the entity’s ordinary activities in exchange for consideration. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. If we conclude a counter-party to a transaction is not a customer or otherwise not within the scope of ASC 606 or ASC 808, we consider the guidance in other accounting literature as applicable or by analogy to account for such transaction. We also consider the guidance in ASC 606 with respect to principal versus agent considerations, in determining the appropriate treatment for the transactions between us and the strategic collaborator and the transactions between us and other third parties. The classification of transactions under our arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. Any consideration related to activities in which we are considered the principal, which includes being in control of the good or service before such good or service is transferred to the customer, are accounted for as gross revenue. We receive payments from our customers based on billing schedules established in each contract. Upfront payments and fees are recorded as contract liabilities upon receipt or when due and may require deferral of revenue recognition to a future period when we perform our obligations under the arrangement. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current liabilities on our condensed consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as non-current liabilities on our condensed consolidated balance sheets. Amounts payable to us are recorded as accounts receivable when our right to consideration is unconditional. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less or the amount is immaterial. As of June 30, 2019 , we had not capitalized any costs to obtain any of our contracts. Collaboration Revenue To determine the appropriate amount of revenue to be recognized for arrangements that we determine are within the scope of ASC 606, we perform the following steps: (i) identify the contract(s) with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) each performance obligation is satisfied. We account for a contract with a customer that is within the scope of ASC 606 when all of the following criteria are met: (i) the arrangement has been approved by the parties and the parties are committed to perform their respective obligations; (ii) each party’s rights regarding the goods and/or services to be transferred can be identified; (iii) the payment terms for the goods and/or services to be transferred can be identified; (iv) the arrangement has commercial substance; and (v) collection of substantially all of the consideration to which we will be entitled in exchange for the goods and/or services that will be transferred to the customer is probable. We also determine the term of the contract based on the period in which we and our customer have present and enforceable rights and obligations for purposes of identifying the performance obligations and determining the transaction price. We evaluate contracts that contain multiple promises to determine which promises are distinct. Promises are considered to be distinct and therefore, accounted for as separate performance obligations, 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 and (ii) the promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. In assessing whether a promise is distinct, we consider factors such as whether: (i) we provide a significant service of integrating goods and/or services with other goods and/or services promised in the contract; (ii) one or more of the goods and/or services significantly modifies or customizes, or are significantly modified or customized by one or more of the other goods and/or services promised in the contract; and (iii) the goods and/or services are highly interdependent or highly interrelated. Individual goods or services (or bundles of goods and/or services) that meet both criteria for being distinct are accounted for as separate performance obligations. Promises that are not distinct at contract inception are combined and accounted for as a single performance obligation. Options to acquire additional goods and/or services are evaluated to determine if such option provides a material right to the customer that it would not have received without entering into the contract. If so, the option is accounted for as a separate performance obligation. If not, the option is considered a marketing offer which would be accounted for as a separate contract upon the customer’s election. The transaction price is generally comprised of an upfront payment due at contract inception and variable consideration in the form of payments for our services and materials and milestone payments due upon the achievement of specified events. Other payments the Company could be entitled to include tiered royalties earned when customers recognize net sales of licensed products. We consider the existence of any significant financing component within our arrangements and have determined that a significant financing component does not exist in our arrangements as substantive business purposes exist to support the payment structure other than to provide a significant benefit of financing. We measure the transaction price based on the amount of consideration we expect to be entitled in exchange for transferring the promised goods and/or services to the customer. We utilize either the expected value method or the most likely amount method to estimate the amount of variable consideration, depending on which method is expected to better predict the amount of consideration to which we will be entitled. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. With respect to arrangements that include payments for a development or regulatory milestone payment, we evaluate whether the associated event is considered probable of achievement and estimate the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within our control or the licensee, such as those dependent upon receipt of regulatory approval, are not considered to be probable of achievement until the triggering event occurs. At the end of each reporting period, we re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, wherein the license is deemed to be the sole or predominant item to which the payments relate, we recognize revenue upon the later of: (i) when the related sales occur or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception. We generally allocate the transaction price to each performance obligation based on a relative standalone selling price basis. We develop assumptions that require judgment to determine the standalone selling price for each performance obligation in consideration of applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated research and development costs. However, in certain instances, we allocate variable consideration entirely to one or more performance obligation if the terms of the variable consideration relate to the satisfaction of the respective performance obligation and the amount allocated is consistent with the amount we would expect to receive for the satisfaction of the respective performance obligation. We recognize revenue based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good or service to the customer. For performance obligations that are satisfied at a point in time, we recognize revenue when control of the goods and/or services is transferred to the customer. For performance obligations that are satisfied over time, we recognize revenue by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress which depicts the performance in transferring control of the associated goods and/or services to the customer. We generally use input methods to measure the progress toward the complete satisfaction of performance obligations satisfied over time. With respect to arrangements containing a license to our intellectual property that is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenue from amounts allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. Grant Revenue We have contracts with the U.S. government’s Defense Advanced Research Projects Agency (DARPA), Biomedical Advanced Research (BARDA), and the Bill & Melinda Gates Foundation (Gates Foundation). We recognize revenue from these contracts as we perform services under these arrangements when the funding is committed. Revenues and related expenses are presented gross in the condensed consolidated statements of operations as we have determined we are the primary obligor under the arrangements relative to the research and development services we perform as lead technical expert. |
Collaboration Revenue | To determine the appropriate amount of revenue to be recognized for arrangements that we determine are within the scope of ASC 606, we perform the following steps: (i) identify the contract(s) with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) each performance obligation is satisfied. We account for a contract with a customer that is within the scope of ASC 606 when all of the following criteria are met: (i) the arrangement has been approved by the parties and the parties are committed to perform their respective obligations; (ii) each party’s rights regarding the goods and/or services to be transferred can be identified; (iii) the payment terms for the goods and/or services to be transferred can be identified; (iv) the arrangement has commercial substance; and (v) collection of substantially all of the consideration to which we will be entitled in exchange for the goods and/or services that will be transferred to the customer is probable. We also determine the term of the contract based on the period in which we and our customer have present and enforceable rights and obligations for purposes of identifying the performance obligations and determining the transaction price. We evaluate contracts that contain multiple promises to determine which promises are distinct. Promises are considered to be distinct and therefore, accounted for as separate performance obligations, 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 and (ii) the promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. In assessing whether a promise is distinct, we consider factors such as whether: (i) we provide a significant service of integrating goods and/or services with other goods and/or services promised in the contract; (ii) one or more of the goods and/or services significantly modifies or customizes, or are significantly modified or customized by one or more of the other goods and/or services promised in the contract; and (iii) the goods and/or services are highly interdependent or highly interrelated. Individual goods or services (or bundles of goods and/or services) that meet both criteria for being distinct are accounted for as separate performance obligations. Promises that are not distinct at contract inception are combined and accounted for as a single performance obligation. Options to acquire additional goods and/or services are evaluated to determine if such option provides a material right to the customer that it would not have received without entering into the contract. If so, the option is accounted for as a separate performance obligation. If not, the option is considered a marketing offer which would be accounted for as a separate contract upon the customer’s election. The transaction price is generally comprised of an upfront payment due at contract inception and variable consideration in the form of payments for our services and materials and milestone payments due upon the achievement of specified events. Other payments the Company could be entitled to include tiered royalties earned when customers recognize net sales of licensed products. We consider the existence of any significant financing component within our arrangements and have determined that a significant financing component does not exist in our arrangements as substantive business purposes exist to support the payment structure other than to provide a significant benefit of financing. We measure the transaction price based on the amount of consideration we expect to be entitled in exchange for transferring the promised goods and/or services to the customer. We utilize either the expected value method or the most likely amount method to estimate the amount of variable consideration, depending on which method is expected to better predict the amount of consideration to which we will be entitled. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. With respect to arrangements that include payments for a development or regulatory milestone payment, we evaluate whether the associated event is considered probable of achievement and estimate the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within our control or the licensee, such as those dependent upon receipt of regulatory approval, are not considered to be probable of achievement until the triggering event occurs. At the end of each reporting period, we re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, wherein the license is deemed to be the sole or predominant item to which the payments relate, we recognize revenue upon the later of: (i) when the related sales occur or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception. We generally allocate the transaction price to each performance obligation based on a relative standalone selling price basis. We develop assumptions that require judgment to determine the standalone selling price for each performance obligation in consideration of applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated research and development costs. However, in certain instances, we allocate variable consideration entirely to one or more performance obligation if the terms of the variable consideration relate to the satisfaction of the respective performance obligation and the amount allocated is consistent with the amount we would expect to receive for the satisfaction of the respective performance obligation. We recognize revenue based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good or service to the customer. For performance obligations that are satisfied at a point in time, we recognize revenue when control of the goods and/or services is transferred to the customer. For performance obligations that are satisfied over time, we recognize revenue by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress which depicts the performance in transferring control of the associated goods and/or services to the customer. We generally use input methods to measure the progress toward the complete satisfaction of performance obligations satisfied over time. With respect to arrangements containing a license to our intellectual property that is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenue from amounts allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. |
Comprehensive Loss | Comprehensive loss includes net loss and other comprehensive income (loss) for the period. Other comprehensive income (loss) consists of unrealized gains and losses on our investments. Total comprehensive loss for all periods presented has been disclosed in the condensed consolidated statements of comprehensive loss. |
Recently Adopted Accounting Standards and Recently Issued Accounting Standards | ASU No. 2014-09, Revenue from Contracts with Customers In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) , which supersedes all existing revenue recognition requirements in ASC 605 and most industry specific guidance. ASC 606 provides a single comprehensive model for use in accounting for revenue arising from contracts with customers. We adopted the new revenue standard on January 1, 2019 using the modified retrospective transition method applied to those contracts which were not completed as of January 1, 2019. We recognized the cumulative effect of the adoption as an adjustment to the opening balance of accumulated deficit in the first quarter of 2019. We have elected to use the practical expedient to aggregate the impact of all contract modifications that occurred prior to the ASC 606 adoption with respect to (i) identification of the satisfied and unsatisfied performance obligations, (ii) determination of the transaction price and (iii) allocation of the transaction price to the satisfied and unsatisfied performance obligations. ASC 606 requires significant judgment and estimates and results in changes to, but not limited to: (i) the determination of the transaction price, including estimates of variable consideration, (ii) the allocation of the transaction price, including the determination of estimated selling price, and (iii) the pattern of recognition, including the application of proportional performance as a measure of progress on service-related promises and application of point-in-time recognition for supply-related promises. We recorded the cumulative-effect adjustment of $28.0 million to the opening balance of accumulated deficit as of January 1, 2019 with a corresponding decrease to deferred revenue. ASU No. 2018-07, Compensation - Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance generally consistent with the accounting for employee share-based compensation. The new standard will be effective for us on January 1, 2020, with early adoption permitted. We early adopted this standard in the first quarter of 2019. The adoption of this standard did not have a material impact on our condensed consolidated financial statements and disclosure. ASU No. 2018-18, Collaborative Arrangements: Clarifying the Interaction between Topic 808 and Topic 606 In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808) : Clarifying the Interaction between Topic 808 and Topic 606, which clarifies the interaction between Topic 808 and Topic 606, Revenue from Contracts with Customers . Currently, Topic 808 does not provide comprehensive recognition or measurement guidance for collaborative arrangements, and the accounting for those arrangements is often based on an analogy to other accounting literature or an accounting policy election. Similarly, aspects of Topic 606 have resulted in diversity in practice on the effect of the revenue standard on the accounting for collaborative arrangements. The standard will become effective for us beginning on January 1, 2021, with early adoption permitted. We early adopted this standard in connection with the adoption of ASC 606 in the first quarter of 2019. The adoption of this standard did not have a material impact on our condensed consolidated financial statements and disclosure. Recently Issued Accounting Standards From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our condensed consolidated financial statements and disclosures. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which supersedes all existing lease guidance. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. The new standard requires lessees to recognize an operating lease with a term greater than one year on their balance sheets as a right-of-use asset and corresponding lease liability, measured at the present value of the lease payments. Lessees are required to classify leases as either finance or operating leases. If the lease is effectively a financed-purchase by the lessee, it is classified as a financing lease, otherwise it is classified as an operating lease. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. ASC 842 provides accounting guidance for transactions that meet specific criteria for a leaseback transaction. If the criteria are not met, the transaction is considered a “failed sale” and the transaction must be accounted for as a financing arrangement. The new standard will be effective for us on December 31, 2019. Upon adoption, the new standard, as amended, allows lessees to apply the transition requirements either (1) retrospectively to each prior reporting period presented in the financial statements with the cumulative effect of applying the new rules recognized at the beginning of the earliest comparative period presented, or (2) retrospectively at the beginning of the period of adoption with the cumulative effect of applying the new rules recognized then. We are currently evaluating the potential impact ASU 2016-02 may have on our financial position and results of operations. Our assessment will include, but is not limited to, evaluating the impact this standard has on the lease of our corporate headquarters at 200 Technology Square in Cambridge, MA, the lease of our office and laboratory space at 500 Technology Square, Cambridge, MA and our manufacturing and additional facilities in Norwood, MA, (see Note 7), and the identification of any embedded leases. In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (ASU 2016-13). ASU 2016-13 will change how companies account for credit losses for most financial assets and certain other instruments. For trade receivables, loans and held-to-maturity debt securities, companies will be required to recognize an allowance for credit losses rather than reducing the carrying value of the asset. ASU 2016-13 will be effective for us on January 1, 2020, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the potential impact that the adoption of ASU 2016-13 will have on the Company’s financial position and results of operations. In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Topic 350): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. This standard requires capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This standard should be applied either retrospectively or prospectively, and will be effective for us on January 1, 2020, with early adoption permitted. We are currently evaluating the potential impact this standard may have on our condensed consolidated financial statements and results of operations upon adoption. ASU No. 2016-18, Statement of Cash Flows: Restricted Cash In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash , which requires the statement of cash flows to explain the change during the period in the total of cash, cash equivalents and restricted cash. When cash, cash equivalents and restricted cash are presented in more than one line item on the balance sheet, the new standard requires a reconciliation of the totals in the statement of cash flows to the related captions in the balance sheet. This reconciliation can be presented either on the face of the statement of cash flows or in the notes to the financial statements. The new standard became effective for us on January 1, 2019. As a result of adopting this new standard using a retrospective transition method for each period presented, we include our restricted cash balance in the cash, cash equivalents and restricted cash reconciliation of operating, investing and financing activities in the condensed consolidated statements of cash flows. |
Summary of Basis of Presentat_3
Summary of Basis of Presentation and Recent Accounting Standards (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Components of Accumulated Other Comprehensive Income | The components of accumulated other comprehensive income for the three and six months ended June 30, 2019 are as follows (in thousands): Unrealized Gain on Available-for-Sale Debt Securities June 30, 2019 Accumulated other comprehensive loss, balance at December 31, 2018 $ (1,320 ) Other comprehensive income 1,911 Accumulated other comprehensive income, balance at March 31, 2019 591 Other comprehensive income 2,150 Accumulated other comprehensive income, balance at June 30, 2019 $ 2,741 |
Effect of Adoption of ASC 606 on Condensed Financial Statements | The following tables summarize the effects of adopting ASC 606 on our condensed consolidated financial statements at June 30, 2019, and for the three and six months ended June 30, 2019 (in thousands, except per share data): June 30, 2019 Condensed Consolidated Balance Sheet As reported under ASC 606 Adjustments Balance without adoption of ASC 606 Deferred revenue, current $ 83,401 $ 3,266 $ 86,667 Deferred revenue, non-current 139,923 1,936 141,859 Accumulated deficit (1,246,354 ) (1,595 ) (1,247,949 ) Three Months Ended June 30, 2019 Condensed Consolidated Statement of Operations As reported under ASC 606 Adjustments Amount without adoption of ASC 606 Revenue: Collaboration revenue $ 9,842 $ 3,155 $ 12,997 Collaboration revenue from related party 188 642 830 Total revenue 13,083 3,797 16,880 Loss from operations (143,936 ) 3,797 (140,139 ) Loss before income taxes (135,378 ) 3,797 (131,581 ) Net loss (135,054 ) 3,797 (131,257 ) Net loss per share - basic and diluted (0.41 ) 0.01 (0.40 ) Six Months Ended June 30, 2019 Condensed Consolidated Statement of Operations As reported under ASC 606 Adjustments Amount without adoption of ASC 606 Revenue: Collaboration revenue $ 23,143 $ 1,369 $ 24,512 Collaboration revenue from related party 1,002 25,019 26,021 Total revenue 29,108 26,388 55,496 Loss from operations (285,769 ) 26,388 (259,381 ) Loss before income taxes (268,059 ) 26,388 (241,671 ) Net loss (267,711 ) 26,388 (241,323 ) Net loss per share - basic and diluted (0.81 ) 0.08 (0.73 ) The effect of the adoption of ASC 606 on our condensed consolidated balance sheet is as follows (in thousands): Condensed Consolidated Balance Sheet Balance at December 31, 2018 Adjustments Balance at January 1, 2019 Deferred revenue, current $ 109,056 $ (27,281 ) $ 81,775 Deferred revenue, non-current 165,352 (3,441 ) 161,911 Accounts receivable 11,686 (2,738 ) 8,948 Accumulated deficit (1,006,627 ) 27,984 (978,643 ) The following table summarizes our total consolidated net revenue from our strategic collaborators for the periods presented (in thousands): Three Months Ended Collaboration Revenue by Strategic Collaborator: June 30, 2019 as reported (under ASU 606) June 30, 2019 without adoption of 606 (under ASC 605) June 30, 2018 as reported (under ASC 605) Merck $ 8,659 $ 8,802 $ 17,095 AstraZeneca 188 830 6,089 Vertex 1,183 4,195 2,390 Total collaboration revenue $ 10,030 $ 13,827 $ 25,574 Six Months Ended Collaboration Revenue by Strategic Collaborator: June 30, 2019 as reported (under ASU 606) June 30, 2019 without adoption of 606 (under ASC 605) June 30, 2018 as reported (under ASC 605) Merck $ 19,346 $ 20,317 $ 33,062 AstraZeneca 1,002 26,021 13,439 Vertex 3,797 4,195 6,533 Total collaboration revenue $ 24,145 $ 50,533 $ 53,034 |
Reconciliation of Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents and restricted cash in the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands): As of June 30, 2019 2018 Cash and cash equivalents $ 151,624 $ 140,619 Restricted cash 62 831 Restricted cash, non-current 11,762 11,532 Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows $ 163,448 $ 152,982 |
Reconciliation of Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash in the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands): As of June 30, 2019 2018 Cash and cash equivalents $ 151,624 $ 140,619 Restricted cash 62 831 Restricted cash, non-current 11,762 11,532 Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows $ 163,448 $ 152,982 |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Research and Development [Abstract] | |
Summary of Total Consolidated Net Revenues from Strategic Collaborators | The following tables summarize the effects of adopting ASC 606 on our condensed consolidated financial statements at June 30, 2019, and for the three and six months ended June 30, 2019 (in thousands, except per share data): June 30, 2019 Condensed Consolidated Balance Sheet As reported under ASC 606 Adjustments Balance without adoption of ASC 606 Deferred revenue, current $ 83,401 $ 3,266 $ 86,667 Deferred revenue, non-current 139,923 1,936 141,859 Accumulated deficit (1,246,354 ) (1,595 ) (1,247,949 ) Three Months Ended June 30, 2019 Condensed Consolidated Statement of Operations As reported under ASC 606 Adjustments Amount without adoption of ASC 606 Revenue: Collaboration revenue $ 9,842 $ 3,155 $ 12,997 Collaboration revenue from related party 188 642 830 Total revenue 13,083 3,797 16,880 Loss from operations (143,936 ) 3,797 (140,139 ) Loss before income taxes (135,378 ) 3,797 (131,581 ) Net loss (135,054 ) 3,797 (131,257 ) Net loss per share - basic and diluted (0.41 ) 0.01 (0.40 ) Six Months Ended June 30, 2019 Condensed Consolidated Statement of Operations As reported under ASC 606 Adjustments Amount without adoption of ASC 606 Revenue: Collaboration revenue $ 23,143 $ 1,369 $ 24,512 Collaboration revenue from related party 1,002 25,019 26,021 Total revenue 29,108 26,388 55,496 Loss from operations (285,769 ) 26,388 (259,381 ) Loss before income taxes (268,059 ) 26,388 (241,671 ) Net loss (267,711 ) 26,388 (241,323 ) Net loss per share - basic and diluted (0.81 ) 0.08 (0.73 ) The effect of the adoption of ASC 606 on our condensed consolidated balance sheet is as follows (in thousands): Condensed Consolidated Balance Sheet Balance at December 31, 2018 Adjustments Balance at January 1, 2019 Deferred revenue, current $ 109,056 $ (27,281 ) $ 81,775 Deferred revenue, non-current 165,352 (3,441 ) 161,911 Accounts receivable 11,686 (2,738 ) 8,948 Accumulated deficit (1,006,627 ) 27,984 (978,643 ) The following table summarizes our total consolidated net revenue from our strategic collaborators for the periods presented (in thousands): Three Months Ended Collaboration Revenue by Strategic Collaborator: June 30, 2019 as reported (under ASU 606) June 30, 2019 without adoption of 606 (under ASC 605) June 30, 2018 as reported (under ASC 605) Merck $ 8,659 $ 8,802 $ 17,095 AstraZeneca 188 830 6,089 Vertex 1,183 4,195 2,390 Total collaboration revenue $ 10,030 $ 13,827 $ 25,574 Six Months Ended Collaboration Revenue by Strategic Collaborator: June 30, 2019 as reported (under ASU 606) June 30, 2019 without adoption of 606 (under ASC 605) June 30, 2018 as reported (under ASC 605) Merck $ 19,346 $ 20,317 $ 33,062 AstraZeneca 1,002 26,021 13,439 Vertex 3,797 4,195 6,533 Total collaboration revenue $ 24,145 $ 50,533 $ 53,034 |
Changes in Balances of Receivables and Contract Liabilities | The following table presents changes in the balances of our receivables and contract liabilities related to our strategic collaboration agreements during the six months ended June 30, 2019 (in thousands): January 1, 2019 Additions Deductions June 30, 2019 Contract Assets: Accounts receivable $ 4,612 $ 5,110 $ (5,204 ) $ 4,518 Contract Liabilities: Deferred revenue $ 240,924 $ 2,292 $ (25,165 ) $ 218,051 During the three and six months ended June 30, 2019 , we recognized the following revenue as a result of the change in the contract liability balances related to our collaboration agreements (in thousands): Revenue recognized in the period from: Three Months Ended June 30, 2019 Six Months Ended June 30, 2019 Amounts included in contract liabilities at the beginning of the period (1) $ 11,583 $ 25,165 (1) We first allocate revenue to the individual contract liability balance outstanding at the beginning of the period until the revenue exceeds that balance. If additional consideration is received on those contracts in subsequent periods, we assume all revenue recognized in the reporting period first applies to the beginning contract liability. |
Financial Instruments (Tables)
Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Cash and Available-for-Sale Securities by Significant Investment Category | The following tables summarize our cash and available-for-sale securities by significant investment category at June 30, 2019 and December 31, 2018 (in thousands): June 30, 2019 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Current Marketable Securities Non- Current Marketable Securities Cash and cash equivalents $ 151,624 $ — $ — $ 151,624 $ 151,624 $ — $ — Available-for-sale: Level 2: Certificates of deposit 136,011 160 (1 ) 136,170 — 132,469 3,701 U.S. treasury securities 153,651 507 — 154,158 — 129,985 24,173 Debt securities of U.S. government agencies and corporate entities 990,203 3,275 (52 ) 993,426 — 656,268 337,158 $ 1,431,489 $ 3,942 $ (53 ) $ 1,435,378 $ 151,624 $ 918,722 $ 365,032 December 31, 2018 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Current Marketable Securities Non- Current Marketable Securities Cash and cash equivalents $ 658,365 $ 20 $ (21 ) $ 658,364 $ 658,364 $ — $ — Available-for-sale: Level 2: Certificates of deposit 173,102 42 (36 ) 173,108 — 157,920 15,188 U.S. treasury securities 152,205 18 (48 ) 152,175 — 152,175 — Debt securities of U.S. government agencies and corporate entities 712,065 40 (1,335 ) 710,770 — 552,968 157,802 $ 1,695,737 $ 120 $ (1,440 ) $ 1,694,417 $ 658,364 $ 863,063 $ 172,990 |
Amortized Cost and Estimated Fair Value of Marketable Securities, by Contractual Maturity | The amortized cost and estimated fair value of marketable securities by contractual maturity at June 30, 2019 are as follows (in thousands): June 30, 2019 Amortized Cost Estimated Fair Value Due in one year or less $ 916,905 $ 918,722 Due after one year through five years 362,960 365,032 Total $ 1,279,865 $ 1,283,754 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets, as of June 30, 2019 and December 31, 2018 consists of the following (in thousands): June 30, December 31, 2019 2018 Prepaid expenses $ 9,138 $ 10,401 Tenant incentives receivables 6,310 10,089 Interest receivable on marketable securities 7,044 7,909 Prepaid expenses and other current assets $ 22,492 $ 28,399 |
Schedule of Property and Equipment, Net | Property and equipment, net, as of June 30, 2019 and December 31, 2018 consists of the following (in thousands): June 30, December 31, 2019 2018 Building $ 140,442 $ 140,442 Laboratory equipment 102,006 96,907 Leasehold improvements 13,632 13,741 Furniture, fixtures and other 2,142 2,122 Computer equipment and software 11,665 11,513 Internally developed software 7,020 7,020 Construction in progress 10,829 4,688 287,736 276,433 Less: Accumulated depreciation (79,227 ) (64,456 ) Property and equipment, net $ 208,509 $ 211,977 |
Schedule of Accrued Liabilities | Accrued liabilities, as of June 30, 2019 and December 31, 2018 consists of the following (in thousands): June 30, December 31, 2019 2018 In-licenses $ — $ 22,000 Property and equipment 5,402 12,089 Compensation-related 16,001 23,406 External goods and services 23,186 21,578 Accrued liabilities $ 44,589 $ 79,073 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments Under Non-Cancelable Operating Lease Agreements | Future minimum lease payments under non-cancelable operating lease agreements at June 30, 2019 , are as follows (in thousands): Fiscal Year Minimum Lease Payments 2019 (remainder of the year) $ 10,206 2020 22,481 2021 24,253 2022 23,697 2023 20,586 Thereafter 137,948 Total $ 239,171 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Options Activity | The following table summarizes our option activity as of June 30, 2019 : Number of Options Weighted- Average Exercise Price per Share Weighted- Average Grant Date Fair Value per Share Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value (1) (in thousands) Outstanding at December 31, 2018 50,821,132 $ 12.16 $ 6.59 7.1 years $ 220,434 Granted 6,280,966 20.24 11.87 Exercised (1,051,793 ) 3.86 3.89 Canceled/forfeited (4,067,618 ) 14.57 8.69 Outstanding at June 30, 2019 51,982,687 13.14 7.05 7.2 years 181,371 Exercisable at June 30, 2019 25,559,777 9.10 4.34 5.5 years 161,093 Vested and expected to vest at June 30, 2019 26,422,410 17.04 9.68 8.9 years 20,278 _______ (1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of common stock for those options in the money as of June 30, 2019 . |
Restricted Common Stock Activity | The following table summarizes our restricted stock activity for the six months ended June 30, 2019 : Number of Weighted Average Fair Value per Share Outstanding, non-vested at December 31, 2018 198,597 $ 12.15 Issued — — Vested (107,475 ) 12.15 Canceled, forfeited and adjustments, net (314 ) 12.15 Outstanding, non-vested at June 30, 2019 90,808 12.15 |
Restricted Common Stock Units Activity | The following table summarizes our restricted stock unit activity during the six months ended June 30, 2019 : Units Weighted-Average per Unit Outstanding, non-vested at December 31, 2018 458,715 $ 11.93 Issued 636,808 20.93 Vested (1) 28,668 11.93 Canceled/forfeited (21,629 ) 20.93 Pending settlement (1) (28,668 ) 11.93 Outstanding, non-vested at June 30, 2019 1,073,894 17.08 _________ (1) The vested restricted stock units will be settled for common stock on the date which is 360 days after the consummation of the IPO. |
Weighted-Average Assumptions Used to Estimate the Fair Value of Options Granted | The weighted-average assumptions used to estimate the fair value of options granted and ESPP for the six months ended June 30, 2019 and 2018 are as follows: Weighted Average Six Months Ended June 30, 2019 2018 Options: Risk-free interest rate 2.42 % 2.71 % Expected term 6.07 years 6.06 years Expected volatility 62 % 64 % Expected dividends — % — % Weighted average fair value per share $ 11.87 $ 8.63 ESPP: Risk-free interest rate 2.31 % Expected term 0.50 years Expected volatility 50 % Expected dividends — % Weighted average fair value per share 19.85 |
Stock-Based Compensation Expense | The following table presents the components and classification of stock-based compensation expense for the three and six months ended June 30, 2019 and 2018 as follows (in thousands): Three Months Ended Six Months Ended June 30, 2019 2018 2019 2018 Options $ 19,994 $ 13,263 $ 37,481 $ 23,311 Restricted common stock and units 1,327 1,090 2,337 2,893 ESPP 174 — 174 — Total $ 21,495 $ 14,353 $ 39,992 $ 26,204 Research and development $ 12,869 $ 8,428 $ 23,652 $ 15,784 General and administrative 8,626 5,925 16,340 10,420 Total $ 21,495 $ 14,353 $ 39,992 $ 26,204 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Loss per Share Attributable to Common Stockholders | Basic and diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2019 and 2018 are calculated as follows (in thousands, except share and per share data): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Numerator: Net loss $ (135,054 ) $ (90,601 ) $ (267,711 ) $ (162,977 ) Cumulative dividends on redeemable convertible preferred stock — (3,481 ) — (6,962 ) Net loss attributable to common stockholders $ (135,054 ) $ (94,082 ) $ (267,711 ) $ (169,939 ) Denominator: Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted 329,176,107 65,938,939 328,994,058 65,686,290 Net loss per share attributable to common stockholders, basic and diluted $ (0.41 ) $ (1.43 ) $ (0.81 ) $ (2.59 ) |
Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share | The following common stock equivalents, presented based on amounts outstanding as of June 30, 2019 and 2018 were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated because their inclusion would have been anti-dilutive: June 30, 2019 2018 Redeemable convertible preferred stock — 236,120,492 Stock options 51,982,687 44,269,380 Restricted common stock 90,808 410,607 Restricted common stock units 1,073,894 458,715 53,147,389 281,259,194 |
Summary of Basis of Presentat_4
Summary of Basis of Presentation and Recent Accounting Standards - Components of Accumulated Other Comprehensive Income (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | |
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||||
Balance at beginning of period | $ 1,338,554 | $ 1,446,033 | $ (688,768) | $ 1,338,554 | $ (688,768) | $ 1,530,241 | $ (613,709) | $ (551,365) |
Other comprehensive income | 2,150 | 1,141 | 4,061 | (852) | ||||
Balance at end of period | 1,338,554 | 1,446,033 | (688,768) | 1,338,554 | (688,768) | |||
Accumulated Other Comprehensive Income | ||||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||||
Balance at beginning of period | 2,741 | 591 | (2,009) | 2,741 | (2,009) | $ (1,320) | $ (3,150) | $ (1,157) |
Other comprehensive income | 2,150 | 1,141 | 4,061 | (852) | ||||
Balance at end of period | 2,741 | 591 | $ (2,009) | $ 2,741 | $ (2,009) | |||
Unrealized Gain on Available-for-Sale Debt Securities | ||||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||||
Other comprehensive income | $ 2,150 | $ 1,911 |
Summary of Basis of Presentat_5
Summary of Basis of Presentation and Recent Accounting Standards - Narrative (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Cumulative-effect adjustment | $ 27,984 | ||
Remaining deferred revenues | $ 218,051 | $ 240,924 | |
Combined 2018 AZ Agreements | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Remaining deferred revenues | 75,800 | 75,700 | 115,600 |
PCV/SAV Agreement | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Remaining deferred revenues | 104,500 | 125,200 | 111,300 |
2016 VEGF Exercise | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Remaining deferred revenues | $ 37,400 | 37,100 | $ 41,200 |
Accumulated Deficit | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Cumulative-effect adjustment | 27,984 | ||
Accounting Standards Update 2014-09 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Decrease in deferred tax asset | 8,400 | ||
Increase (decrease) in deferred revenue | (30,700) | ||
Decrease in valuation allowance | 8,400 | ||
Accounting Standards Update 2014-09 | Combined 2018 AZ Agreements | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Increase (decrease) in deferred revenue | (39,900) | ||
Accounting Standards Update 2014-09 | PCV/SAV Agreement | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Increase (decrease) in deferred revenue | 13,900 | ||
Accounting Standards Update 2014-09 | 2016 VEGF Exercise | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Increase (decrease) in deferred revenue | (4,300) | ||
Accounting Standards Update 2014-09 | Accumulated Deficit | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Cumulative-effect adjustment | $ 28,000 |
Summary of Basis of Presentat_6
Summary of Basis of Presentation and Recent Accounting Standards - Effect of Adoption of ASC 606 on Condensed Consolidated Financial Statements (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jan. 01, 2019 | Dec. 31, 2018 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Deferred revenue, current | $ 83,401 | $ 83,401 | $ 81,775 | $ 109,056 | ||
Deferred revenue, non-current | 139,923 | 139,923 | 161,911 | 165,352 | ||
Accounts receivable | 3,498 | 3,498 | 8,948 | 11,686 | ||
Accumulated deficit | (1,246,354) | (1,246,354) | (978,643) | (1,006,627) | ||
Total revenue | 13,083 | 29,108 | ||||
Loss from operations | (143,936) | $ (97,015) | (285,769) | $ (174,417) | ||
Loss before income taxes | (135,378) | (90,443) | (268,059) | (162,819) | ||
Net loss | $ (135,054) | $ (90,601) | $ (267,711) | $ (162,977) | ||
Net loss per share - basic and diluted (usd per share) | $ (0.41) | $ (1.43) | $ (0.81) | $ (2.59) | ||
Collaboration revenue | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Total revenue | $ 9,842 | $ 23,143 | ||||
Collaboration revenue from related party | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Total revenue | 188 | 1,002 | ||||
Accounting Standards Update 2014-09 | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Accounts receivable | (2,700) | |||||
Balance without adoption of ASC 606 | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Deferred revenue, current | 86,667 | 86,667 | 109,056 | |||
Deferred revenue, non-current | 141,859 | 141,859 | 165,352 | |||
Accounts receivable | 11,686 | |||||
Accumulated deficit | (1,247,949) | (1,247,949) | $ (1,006,627) | |||
Total revenue | 16,880 | 55,496 | ||||
Loss from operations | (140,139) | (259,381) | ||||
Loss before income taxes | (131,581) | (241,671) | ||||
Net loss | $ (131,257) | $ (241,323) | ||||
Net loss per share - basic and diluted (usd per share) | $ (0.40) | $ (0.73) | ||||
Balance without adoption of ASC 606 | Collaboration revenue | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Total revenue | $ 12,997 | $ 24,512 | ||||
Balance without adoption of ASC 606 | Collaboration revenue from related party | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Total revenue | 830 | 26,021 | ||||
Adjustments | Accounting Standards Update 2014-09 | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Deferred revenue, current | 3,266 | 3,266 | (27,281) | |||
Deferred revenue, non-current | 1,936 | 1,936 | (3,441) | |||
Accounts receivable | (2,738) | |||||
Accumulated deficit | (1,595) | (1,595) | $ 27,984 | |||
Total revenue | 3,797 | 26,388 | ||||
Loss from operations | 3,797 | 26,388 | ||||
Loss before income taxes | 3,797 | 26,388 | ||||
Net loss | $ 3,797 | $ 26,388 | ||||
Net loss per share - basic and diluted (usd per share) | $ 0.01 | $ 0.08 | ||||
Adjustments | Accounting Standards Update 2014-09 | Collaboration revenue | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Total revenue | $ 3,155 | $ 1,369 | ||||
Adjustments | Accounting Standards Update 2014-09 | Collaboration revenue from related party | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Total revenue | $ 642 | $ 25,019 |
Summary of Basis of Presentat_7
Summary of Basis of Presentation and Recent Accounting Standards - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 151,624 | $ 658,364 | $ 140,619 | |
Restricted cash | 62 | 595 | 831 | |
Restricted cash, non-current | 11,762 | 11,532 | 11,532 | |
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows | $ 163,448 | $ 670,491 | $ 152,982 | $ 147,608 |
Collaboration Agreements - Summ
Collaboration Agreements - Summary of Total Consolidated Net Revenues from Strategic Collaborators (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | $ 13,083 | $ 29,108 | ||
Balance without adoption of ASC 606 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | 16,880 | 55,496 | ||
Collaboration Revenue by Strategic Collaborator | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | 10,030 | 24,145 | ||
Collaboration Revenue by Strategic Collaborator | Merck | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | 8,659 | 19,346 | ||
Collaboration Revenue by Strategic Collaborator | AstraZeneca | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | 188 | 1,002 | ||
Collaboration Revenue by Strategic Collaborator | Vertex | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | 1,183 | 3,797 | ||
Collaboration Revenue by Strategic Collaborator | Balance without adoption of ASC 606 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | 13,827 | $ 25,574 | 50,533 | $ 53,034 |
Collaboration Revenue by Strategic Collaborator | Balance without adoption of ASC 606 | Merck | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | 8,802 | 17,095 | 20,317 | 33,062 |
Collaboration Revenue by Strategic Collaborator | Balance without adoption of ASC 606 | AstraZeneca | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | 830 | 6,089 | 26,021 | 13,439 |
Collaboration Revenue by Strategic Collaborator | Balance without adoption of ASC 606 | Vertex | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total collaboration revenue | $ 4,195 | $ 2,390 | $ 4,195 | $ 6,533 |
Collaboration Agreements - Chan
Collaboration Agreements - Changes in Balances of Receivables and Contract Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Contract Assets: | ||
Beginning balance | $ 4,612 | |
Additions | 5,110 | |
Deductions | (5,204) | |
Ending balance | $ 4,518 | 4,518 |
Contract Liabilities: | ||
Beginning balance | 240,924 | |
Additions | 2,292 | |
Deductions | (25,165) | |
Ending balance | 218,051 | 218,051 |
Amounts included in contract liabilities at the beginning of the period | $ 11,583 | $ 25,165 |
Collaboration Agreements - Rema
Collaboration Agreements - Remaining Performance Obligation (Details) - USD ($) $ in Millions | Jun. 30, 2019 | Jan. 01, 2019 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | $ 268.2 | |
PCV/SAV Agreement | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | $ 213 | |
PCV/SAV Agreement | Upfront Payment | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 200 | |
PCV/SAV Agreement | Upfront Payment, Premium Associated With Contemporaneous Sale Of Preferred Stock | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 13 | |
PCV/SAV Agreement | PCV Performance Obligation | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 206.3 | |
PCV/SAV Agreement | KRAS Performance Obligation | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 6.7 | |
2015 Merck Agreement | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 65 | |
2015 Merck Agreement | Milestone Payments | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 5 | |
2015 Merck Agreement | Upfront Payment | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 60 | |
2015 Merck Agreement | Upfront Payment, Research And Development | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 50 | |
2015 Merck Agreement | Upfront Payment, Funding From 2016 Amendment | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 10 | |
2016 VEGF Exercise | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 55.1 | |
2016 VEGF Exercise | Fixed Payments | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 40 | |
2016 VEGF Exercise | Option Exercise Fee | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 10 | |
2016 VEGF Exercise | Variable Consideration | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 15.1 | |
2016 VEGF Exercise | Milestone Payments | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 30 | |
2013 AZ Agreements | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 240 | |
Combined 2018 AZ Agreements | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 400 | |
Combined 2018 AZ Agreements | Variable Consideration | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 160 | |
Combined 2018 AZ Agreements | Estimated Reimbursement | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 40 | |
Combined 2018 AZ Agreements | Milestone Payments | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 120 | |
Combined 2018 AZ Agreements | Milestone Payments | Toxicity Milestone | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 60 | |
Combined 2018 AZ Agreements | Milestone Payments | Competition Milestone | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 60 | |
Combined 2018 AZ Agreements | Combined 2018 AZ Agreement Performance Obligation | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 292.4 | |
Combined 2018 AZ Agreements | IL12 Performance Obligation | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 8.1 | |
Combined 2018 AZ Agreements | Oncology Development Target Performance Obligation | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 8.1 | |
Combined 2018 AZ Agreements | Development And Commercialization License And Manufacturing Obligations For IL12 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 90.1 | |
Combined 2018 AZ Agreements | Development And Commercialization Rights And Manufacturing Services For An Oncology Development Target | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 1.6 | |
Vertex Agreement | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 24.4 | |
Vertex Agreement | Upfront Payment | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 20 | |
Vertex Agreement | Research And Development Funding | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | $ 4.4 |
Collaboration Agreements - Astr
Collaboration Agreements - AstraZeneca - Strategic Alliances in Cardiovascular and Oncology (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Jun. 30, 2018option | Oct. 31, 2017 | Jan. 31, 2016 | Mar. 31, 2013USD ($)milestoneoption | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($)option | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($)option | Dec. 31, 2018USD ($) | Dec. 31, 2016USD ($) | Jan. 01, 2019USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Transaction price | $ 268,200,000 | $ 268,200,000 | |||||||||
Total collaboration revenue | 13,083,000 | 29,108,000 | |||||||||
Deferred revenue | 218,051,000 | 218,051,000 | $ 240,924,000 | ||||||||
Revenue | 13,083,000 | $ 28,851,000 | 29,108,000 | $ 57,890,000 | |||||||
Collaboration revenue | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Total collaboration revenue | 9,842,000 | 23,143,000 | |||||||||
Revenue | 9,842,000 | $ 19,742,000 | 23,143,000 | 39,852,000 | |||||||
2013 AZ Agreements | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Number of options | option | 40 | ||||||||||
Upfront cash payments | $ 240,000,000 | $ 10,000,000 | |||||||||
Estimated arrangement consideration | $ 180,000,000 | ||||||||||
Number of milestones | milestone | 3 | ||||||||||
Option exercise fee | $ 10,000,000 | ||||||||||
Termination period | 90 days | ||||||||||
Transaction price | $ 240,000,000 | ||||||||||
2013 AZ Agreements | VEGF-A product (AZD8601) | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Upfront cash payments | 30,000,000 | ||||||||||
2013 AZ Agreements | Development Milestones | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Estimated arrangement consideration | $ 100,000,000 | ||||||||||
2013 AZ Agreements | Regulatory Milestones | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Estimated arrangement consideration | 100,000,000 | ||||||||||
2013 AZ Agreements | Commercial Milestones | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Estimated arrangement consideration | $ 200,000,000 | ||||||||||
2013 AZ Agreements | Maximum | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Earn-out payments | 12.00% | ||||||||||
2016 AZ Agreement | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Termination period | 90 days | ||||||||||
Suspension period | 12 months | ||||||||||
2016 AZ Agreement | Maximum | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Tiered royalties at default rate | 20.00% | ||||||||||
Tiered royalties | 30.00% | ||||||||||
2016 AZ Agreement | Minimum | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Tiered royalties | 10.00% | ||||||||||
2017 AZ Agreement | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Termination period | 90 days | ||||||||||
Suspension period | 12 months | ||||||||||
2017 AZ Agreement | Collaboration revenue | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Revenue | 0 | 0 | $ 0 | ||||||||
2017 AZ Agreement | Maximum | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Tiered royalties | 30.00% | ||||||||||
2017 AZ Agreement | Minimum | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Tiered royalties | 10.00% | ||||||||||
2018 A&R Agreements | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Number of options | option | 40 | 40 | 40 | ||||||||
Termination period | 90 days | ||||||||||
Combined 2018 AZ Agreements | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Increase to the transaction price | 300,000 | ||||||||||
Transaction price | 400,000,000 | ||||||||||
Deferred revenue | 75,800,000 | 75,800,000 | 115,600,000 | 75,700,000 | |||||||
Combined 2018 AZ Agreements | Collaboration revenue | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Total collaboration revenue | 0 | $ 6,000,000 | 800,000 | $ 13,400,000 | |||||||
2016 VEGF Exercise | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Transaction price | 55,100,000 | ||||||||||
Deferred revenue | 37,400,000 | 37,400,000 | $ 41,200,000 | 37,100,000 | |||||||
2016 VEGF Exercise | Collaboration revenue | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Total collaboration revenue | $ 0 | $ 0 | $ 0 | ||||||||
IL12 Performance Obligation | Combined 2018 AZ Agreements | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Transaction price | $ 8,100,000 |
Collaboration Agreements - Merc
Collaboration Agreements - Merck – Strategic Alliances in Infectious Diseases and Cancer Vaccines (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 34 Months Ended | 53 Months Ended | ||||||||
Jan. 31, 2019 | Apr. 30, 2018USD ($) | Jun. 30, 2016USD ($) | Jan. 31, 2016USD ($) | Jan. 31, 2015USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2015 | May 31, 2019USD ($)candidate | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Upfront payment | $ (23,100,000) | $ (2,283,000) | |||||||||||
Total collaboration revenue (contra-revenue) | $ 13,083,000 | 29,108,000 | |||||||||||
Deferred revenue | 218,051,000 | 218,051,000 | $ 240,924,000 | ||||||||||
Amortization of deferred revenue due to the satisfaction of our performance obligation during the period | 11,583,000 | 25,165,000 | |||||||||||
Collaboration revenue | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Total collaboration revenue (contra-revenue) | 9,842,000 | 23,143,000 | |||||||||||
2015 Merck Agreement | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Performance period | 3 years | 3 years | 3 years | ||||||||||
Research period | 4 years | 4 years | |||||||||||
Number of product candidates | candidate | 5 | ||||||||||||
Upfront payment | $ 50,000,000 | ||||||||||||
Estimated arrangement consideration | 300,000,000 | ||||||||||||
Total collaboration revenue (contra-revenue) | $ 6,800,000 | 12,700,000 | |||||||||||
Proceeds from equity investment | $ 50,000,000 | ||||||||||||
Upfront cash payments | $ 10,000,000 | ||||||||||||
Decrease to the transaction price | 2,100,000 | ||||||||||||
Deferred revenue | 0 | 0 | 0 | ||||||||||
2015 Merck Agreement | Milestone Payments | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Total collaboration revenue (contra-revenue) | $ 5,000,000 | ||||||||||||
Separate Agreements With Merck | Collaboration revenue | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Total collaboration revenue (contra-revenue) | (1,800,000) | (1,300,000) | |||||||||||
PCV Agreement | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Estimated arrangement consideration | $ 250,000,000 | ||||||||||||
Upfront cash payments | $ 200,000,000 | ||||||||||||
PCV Agreement | Series H Redeemable Convertible Preferred Stock | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Aggregate net proceeds from the offering | $ 125,000,000 | ||||||||||||
Premium recorded to deferred revenue | 13,000,000 | ||||||||||||
PCV Agreement | PCV products | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Estimated arrangement consideration | 243,000,000 | 243,000,000 | 243,000,000 | ||||||||||
PCV/SAV Agreement | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Decrease to the transaction price | 0 | ||||||||||||
Deferred revenue | 104,500,000 | 104,500,000 | $ 125,200,000 | $ 111,300,000 | |||||||||
PCV/SAV Agreement | PCV products | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Estimated arrangement consideration | $ 243,000,000 | ||||||||||||
PCV/SAV Agreement | Collaboration revenue | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Total collaboration revenue (contra-revenue) | $ 10,400,000 | $ 10,300,000 | $ 20,600,000 | $ 20,300,000 |
Collaboration Agreements - Vert
Collaboration Agreements - Vertex – 2016 Strategic Alliance in Cystic Fibrosis (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jul. 31, 2019 | Jul. 31, 2016USD ($)extension_period | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Total collaboration revenue | $ 13,083,000 | $ 29,108,000 | |||||
Amortization of deferred revenue due to the satisfaction of our performance obligation during the period | 11,583,000 | 25,165,000 | |||||
Deferred revenue | 218,051,000 | 218,051,000 | $ 240,924,000 | ||||
Collaboration revenue | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Total collaboration revenue | 9,842,000 | 23,143,000 | |||||
Vertex Agreement | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Upfront cash payments | $ 20,000,000 | ||||||
Research period | 3 years | ||||||
Research extension period | 1 year | ||||||
Payment received, research extension period | 18 months | ||||||
Number of extension periods | extension_period | 2 | ||||||
Proceeds from equity investment | $ 20,000,000 | ||||||
Termination period | 90 days | ||||||
Written notice period | 180 days | ||||||
Increase to the transaction price | 0 | ||||||
Deferred revenue | 0 | 0 | $ 3,300,000 | ||||
Vertex Agreement | Subsequent Event | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Research extension period | 6 months | ||||||
Vertex Agreement | Collaboration revenue | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Total collaboration revenue | $ 1,200,000 | $ 2,400,000 | $ 3,800,000 | $ 6,500,000 | |||
Vertex Agreement | Development Milestones | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Estimated arrangement consideration | $ 55,000,000 | ||||||
Vertex Agreement | Regulatory Milestones | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Estimated arrangement consideration | 220,000,000 | ||||||
Vertex Agreement | Regulatory Milestones, Subsequent Products | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Estimated arrangement consideration | $ 3,000,000 |
Collaboration Agreements - Timi
Collaboration Agreements - Timing of Satisfaction (Details) - USD ($) $ in Millions | Jun. 30, 2019 | Jan. 01, 2019 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | $ 268.2 | |
Combined 2018 AZ Agreements | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | $ 400 | |
Combined 2018 AZ Agreements | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-04-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 9.7 | |
Combined 2018 AZ Agreements | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: (nil) | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 112.5 | |
2016 VEGF Exercise | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 55.1 | |
2016 VEGF Exercise | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-04-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 51.1 | |
PCV/SAV Agreement | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | 213 | |
PCV/SAV Agreement | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-04-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | $ 104.5 | |
Vertex Agreement | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Transaction price | $ 24.4 |
Grants (Details)
Grants (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Mar. 31, 2019USD ($) | Sep. 30, 2016USD ($) | Jan. 31, 2016USD ($) | Oct. 31, 2013USD ($) | Jun. 30, 2019USD ($)contract_option | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($)contract_option | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) | |
Disaggregation of Revenue [Line Items] | |||||||||
Total revenue | $ 13,083,000 | $ 29,108,000 | |||||||
Deferred revenue | 218,051,000 | 218,051,000 | $ 240,924,000 | ||||||
BARDA | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Award amount | $ 125,800,000 | ||||||||
Amount committed for funding | 117,300,000 | 117,300,000 | |||||||
Available funding | $ 8,500,000 | $ 8,500,000 | |||||||
BARDA | Initial base award | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Award amount | 8,200,000 | ||||||||
BARDA | Contract options | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Award amount | $ 117,600,000 | ||||||||
Number of contract options exercised | contract_option | 3 | 3 | |||||||
Number of contract options | contract_option | 4 | 4 | |||||||
BARDA | Grant revenue | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Total revenue | $ 1,900,000 | $ 1,600,000 | $ 3,400,000 | $ 2,600,000 | |||||
The Bill & Melinda Gates Foundation | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Award amount | $ 100,000,000 | ||||||||
Available funding | 80,000,000 | 80,000,000 | |||||||
Deferred revenue | 3,700,000 | 3,700,000 | $ 800,000 | ||||||
The Bill & Melinda Gates Foundation | Initial project | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Award amount | $ 20,000,000 | ||||||||
Amount committed for funding | 21,100,000 | 21,100,000 | |||||||
The Bill & Melinda Gates Foundation | Follow-on project | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Award amount | $ 1,100,000 | ||||||||
The Bill & Melinda Gates Foundation | Grant revenue | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Total revenue | 1,000,000 | 100,000 | 1,300,000 | 400,000 | |||||
DARPA | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Award amount | $ 24,600,000 | 19,700,000 | |||||||
Amount committed for funding | 19,700,000 | 19,700,000 | $ 19,700,000 | 19,700,000 | |||||
DARPA | Grant revenue | |||||||||
Disaggregation of Revenue [Line Items] | |||||||||
Total revenue | $ 0 | $ 1,300,000 | $ 1,500,000 |
Financial Instruments - Summary
Financial Instruments - Summary of Cash and Available-for-Sale Securities by Significant Investment Category (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 1,279,865 | |
Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 1,431,489 | $ 1,695,737 |
Unrealized Gains | 3,942 | 120 |
Unrealized Losses | (53) | (1,440) |
Fair Value | 1,435,378 | 1,694,417 |
Level 2 | Cash and Cash Equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 151,624 | 658,364 |
Level 2 | Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 918,722 | 863,063 |
Level 2 | Non- Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 365,032 | 172,990 |
Cash and Cash Equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 151,624 | 658,365 |
Unrealized Gains | 0 | 20 |
Unrealized Losses | 0 | (21) |
Fair Value | 151,624 | 658,364 |
Cash and Cash Equivalents | Cash and Cash Equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 151,624 | 658,364 |
Cash and Cash Equivalents | Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 0 | 0 |
Cash and Cash Equivalents | Non- Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 0 | 0 |
Certificates of deposit | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 136,011 | 173,102 |
Unrealized Gains | 160 | 42 |
Unrealized Losses | (1) | (36) |
Fair Value | 136,170 | 173,108 |
Certificates of deposit | Level 2 | Cash and Cash Equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 0 | 0 |
Certificates of deposit | Level 2 | Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 132,469 | 157,920 |
Certificates of deposit | Level 2 | Non- Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 3,701 | 15,188 |
U.S. treasury securities | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 153,651 | 152,205 |
Unrealized Gains | 507 | 18 |
Unrealized Losses | 0 | (48) |
Fair Value | 154,158 | 152,175 |
U.S. treasury securities | Level 2 | Cash and Cash Equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 0 | 0 |
U.S. treasury securities | Level 2 | Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 129,985 | 152,175 |
U.S. treasury securities | Level 2 | Non- Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 24,173 | 0 |
Debt securities of U.S. government agencies and corporate entities | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 990,203 | 712,065 |
Unrealized Gains | 3,275 | 40 |
Unrealized Losses | (52) | (1,335) |
Fair Value | 993,426 | 710,770 |
Debt securities of U.S. government agencies and corporate entities | Level 2 | Cash and Cash Equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 0 | 0 |
Debt securities of U.S. government agencies and corporate entities | Level 2 | Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 656,268 | 552,968 |
Debt securities of U.S. government agencies and corporate entities | Level 2 | Non- Current Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | $ 337,158 | $ 157,802 |
Financial Instruments - Amortiz
Financial Instruments - Amortized Cost and Estimated Fair Value of Marketable Securities, by Contractual Maturity (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Amortized Cost | |
Due in one year or less | $ 916,905 |
Due after one year through five years | 362,960 |
Amortized Cost | 1,279,865 |
Estimated Fair Value | |
Due in one year or less | 918,722 |
Due after one year through five years | 365,032 |
Total | $ 1,283,754 |
Financial Instruments - Narrati
Financial Instruments - Narrative (Details) $ in Millions | Jun. 30, 2019USD ($)security | Dec. 31, 2018USD ($)security |
Investments, Debt and Equity Securities [Abstract] | ||
Number of available-for-sale securities in a continuous unrealized loss position for more than 12 months | security | 11 | 25 |
Estimated fair value of total investment portfolio in a continuous unrealized loss position for more than 12 months | $ 36.5 | $ 82.8 |
Gross unrealized loss of total investment portfolio in a continuous unrealized loss position for more than 12 months | $ 0.1 | $ 0.4 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Prepaid expenses | $ 9,138 | $ 10,401 |
Tenant incentives receivables | 6,310 | 10,089 |
Interest receivable on marketable securities | 7,044 | 7,909 |
Prepaid expenses and other current assets | $ 22,492 | $ 28,399 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | $ 287,736 | $ 287,736 | $ 276,433 | ||
Less: Accumulated depreciation | (79,227) | (79,227) | (64,456) | ||
Property and equipment, net | 208,509 | 208,509 | 211,977 | ||
Depreciation and amortization | 7,500 | $ 5,900 | 14,817 | $ 11,031 | |
Building | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 140,442 | 140,442 | 140,442 | ||
Laboratory equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 102,006 | 102,006 | 96,907 | ||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 13,632 | 13,632 | 13,741 | ||
Furniture, fixtures and other | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 2,142 | 2,142 | 2,122 | ||
Computer equipment and software | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 11,665 | 11,665 | 11,513 | ||
Internally developed software | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 7,020 | 7,020 | 7,020 | ||
Construction in progress | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | $ 10,829 | $ 10,829 | $ 4,688 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
In-licenses | $ 0 | $ 22,000 |
Property and equipment | 5,402 | 12,089 |
Compensation-related | 16,001 | 23,406 |
External goods and services | 23,186 | 21,578 |
Accrued liabilities | $ 44,589 | $ 79,073 |
Commitments and Contingencies -
Commitments and Contingencies - Lease Obligations (Details) ft² in Thousands, $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019USD ($)ft²campusextension_period | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($)ft²campusextension_period | Jun. 30, 2018USD ($) | Feb. 28, 2019ft²extension_period | |
Operating Leased Assets [Line Items] | |||||
Number of campuses | campus | 2 | 2 | |||
Rent expense | $ | $ 5.4 | $ 4.8 | $ 10.2 | $ 10 | |
Cambridge, MA | |||||
Operating Leased Assets [Line Items] | |||||
Area of office space (in sqft) | 200 | 200 | |||
Norwood, MA | |||||
Operating Leased Assets [Line Items] | |||||
Area of office space (in sqft) | 200 | 200 | 200 | ||
Number of extension terms | extension_period | 2 | 2 | 4 | ||
Extension period | 10 years | 10 years | 5 years | ||
Percentage subleased to third party | 64.00% |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Lease Payments Under Non-Cancelable Operating Lease Agreements (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Minimum Lease Payments | |
2019 (remainder of the year) | $ 10,206 |
2020 | 22,481 |
2021 | 24,253 |
2022 | 23,697 |
2023 | 20,586 |
Thereafter | 137,948 |
Total | $ 239,171 |
Commitments and Contingencies_3
Commitments and Contingencies - Strategic Collaborations (Details) - PCV Agreement - USD ($) $ in Millions | Jun. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2016 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Budgeted amount | $ 250 | ||
PCV products | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Budgeted amount | $ 243 | $ 243 |
Commitments and Contingencies_4
Commitments and Contingencies - Purchase Commitments and Purchase Orders (Details) - USD ($) $ in Millions | Jun. 30, 2019 | Dec. 31, 2018 |
Clinical Operations And Support Commitment | ||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||
Cancelable open purchase orders | $ 83.9 | $ 64.2 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 11, 2018 | Jun. 30, 2018 | Jun. 30, 2019 | Dec. 31, 2018 | May 07, 2018 | Feb. 28, 2018 |
Subsidiary, Sale of Stock [Line Items] | ||||||
Common stock, shares authorized | 1,600,000,000 | 1,600,000,000 | 1,600,000,000 | 775,000,000 | ||
Redeemable convertible preferred stock, shares authorized | 509,352,795 | |||||
Common stock, par value (usd per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Preferred stock, shares authorized (in shares) | 162,000,000 | 162,000,000 | 162,000,000 | |||
Preferred stock, par value (usd per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Offering expenses | $ 474 | |||||
IPO | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Shares of common stock issued (in shares) | 26,275,993 | |||||
Price per share (usd per share) | $ 23 | |||||
Aggregate net proceeds from the offering | $ 563,000 | |||||
Underwriting discounts | 33,200 | |||||
Offering expenses | $ 8,100 | |||||
IPO | Common Stock | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Preferred stock converted into common stock (in shares) | 236,012,913 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Dec. 05, 2018 | Jun. 30, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Aggregate number of shares authorized for issuance (in shares) | 71,300,000 | ||
Stock options exercised (in shares) | 1,051,793 | ||
Total intrinsic value of options exercised (less than for the year ended December 31, 2017) | $ 14,800 | ||
Total consideration recorded as a result of stock option exercises | 4,100 | ||
Total unrecognized compensation cost related to non-vested stock-based compensation | $ 231,700 | ||
Weighted-average period of cost expected to be recognized | 3 years 4 months 10 days | ||
Stock Option And Incentive Plan 2018 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of additional shares of common stock authorized for issuance (in shares) | 13,200,000 | ||
Shares available for future grant (in shares) | 18,100,000 | ||
ESPP | Employee Stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Aggregate number of shares authorized for issuance (in shares) | 810,000 | ||
Offering period | 6 years | ||
Purchase price at which shares are sold, percent | 85.00% | ||
Minimum percentage of compensation through payroll deductions | 1.00% | ||
Maximum percentage of compensation through payroll deductions | 50.00% | ||
Maximum shares to be purchased during purchase period (in shares) | 3,000 | ||
Maximum value of shares to be purchased during purchase period | $ 25 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Options Activity (Details) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | |
Number of Options | ||
Outstanding at beginning of period (in shares) | shares | 50,821,132 | |
Granted (in shares) | shares | 6,280,966 | |
Exercised (in shares) | shares | (1,051,793) | |
Cancelled/forfeited (in shares) | shares | (4,067,618) | |
Outstanding at end of period (in shares) | shares | 51,982,687 | 50,821,132 |
Weighted- Average Exercise Price per Share | ||
Outstanding at beginning of period (usd per share) | $ 12.16 | |
Granted (usd per share) | 20.24 | |
Exercised (usd per share) | 3.86 | |
Cancelled/forfeited (usd per share) | 14.57 | |
Outstanding at end of period (usd per share) | 13.14 | $ 12.16 |
Weighted- Average Grant Date Fair Value per Share | ||
Outstanding at beginning of period (usd per share) | 6.59 | |
Granted (usd per share) | 11.87 | |
Exercised (usd per share) | 3.89 | |
Cancelled/forfeited (usd per share) | 8.69 | |
Outstanding at end of period (usd per share) | $ 7.05 | $ 6.59 |
Outstanding and Exercisable | ||
Number of Options, Exercisable (in shares) | shares | 25,559,777 | |
Weighted- Average Exercise Price per Share, Exercisable (usd per share) | $ 9.10 | |
Weighted- Average Grant Date Fair Value per Share, Exercisable (usd per share) | $ 4.34 | |
Weighted- Average Remaining Contractual Term, Outstanding | 7 years 2 months 15 days | 7 years 1 month |
Weighted- Average Remaining Contractual Term, Exercisable | 5 years 6 months | |
Aggregate Intrinsic Value, Outstanding | $ | $ 181,371 | $ 220,434 |
Aggregate Intrinsic Value, Exercisable | $ | $ 161,093 | |
Vested and expected to vest | ||
Number of Options (in shares) | shares | 26,422,410 | |
Weighted- Average Exercise Price per Share (usd per share) | $ 17.04 | |
Weighted- Average Grant Date Fair Value per Share | $ 9.68 | |
Weighted- Average Remaining Contractual Term | 8 years 11 months | |
Aggregate Intrinsic Value | $ | $ 20,278 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Common Stock and Common Stock Units Activity (Details) | 6 Months Ended |
Jun. 30, 2019$ / sharesshares | |
Restricted Common Stock | |
Number of Shares/Units | |
Outstanding, non-vested at beginning of period (in shares) | shares | 198,597 |
Issued (in shares) | shares | 0 |
Vested (in shares) | shares | 107,475 |
Canceled, forfeited and adjustments, net (in shares) | shares | (314) |
Outstanding, non-vested at end of period (in shares) | shares | 90,808 |
Weighted-Average Fair Value per Share/Unit | |
Outstanding, non-vested at beginning of period (usd per share) | $ / shares | $ 12.15 |
Issued (usd per share) | $ / shares | 0 |
Vested (usd per share) | $ / shares | 12.15 |
Canceled, forfeited and adjustments, net (usd per share) | $ / shares | 12.15 |
Outstanding, non-vested at end of period (usd per share) | $ / shares | $ 12.15 |
Restricted Common Stock Units | |
Number of Shares/Units | |
Outstanding, non-vested at beginning of period (in shares) | shares | 458,715 |
Issued (in shares) | shares | 636,808 |
Vested (in shares) | shares | 28,668 |
Canceled, forfeited and adjustments, net (in shares) | shares | (21,629) |
Pending settlement (in shares) | shares | (28,668) |
Outstanding, non-vested at end of period (in shares) | shares | 1,073,894 |
Weighted-Average Fair Value per Share/Unit | |
Outstanding, non-vested at beginning of period (usd per share) | $ / shares | $ 11.93 |
Issued (usd per share) | $ / shares | 20.93 |
Vested (usd per share) | $ / shares | 11.93 |
Canceled, forfeited and adjustments, net (usd per share) | $ / shares | 20.93 |
Pending settlement (usd per share) | $ / shares | 11.93 |
Outstanding, non-vested at end of period (usd per share) | $ / shares | $ 17.08 |
Settlement period after consummation of IPO | 360 days |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted-Average Assumptions Used to Estimate the Fair Value of Options Granted (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.42% | 2.71% |
Expected term | 6 years 25 days | 6 years 22 days |
Expected volatility | 62.00% | 64.00% |
Expected dividends | 0.00% | 0.00% |
Options | Weighted average | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value per share (usd per share) | $ 11.87 | $ 8.63 |
ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.31% | |
Expected term | 6 months | |
Expected volatility | 50.00% | |
Expected dividends | 0.00% | |
ESPP | Weighted average | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value per share (usd per share) | $ 19.85 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 21,495 | $ 14,353 | $ 39,992 | $ 26,204 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 12,869 | 8,428 | 23,652 | 15,784 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 8,626 | 5,925 | 16,340 | 10,420 |
Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 19,994 | 13,263 | 37,481 | 23,311 |
Restricted common stock and units | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 1,327 | 1,090 | 2,337 | 2,893 |
ESPP | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 174 | $ 0 | $ 174 | $ 0 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Cumulative-effect adjustment | $ 27,984 | ||
Decrease in accounts receivable | $ (3,498) | (8,948) | $ (11,686) |
Accumulated Deficit | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Cumulative-effect adjustment | 27,984 | ||
Accounting Standards Update 2014-09 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | 8,400 | ||
Decrease in deferred revenue | 30,700 | ||
Decrease in accounts receivable | 2,700 | ||
Decrease in deferred tax asset | 8,400 | ||
Accounting Standards Update 2014-09 | Accumulated Deficit | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Cumulative-effect adjustment | $ 28,000 |
Net Loss per Share - Basic and
Net Loss per Share - Basic and Diluted Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Numerator: | ||||
Net loss | $ (135,054) | $ (90,601) | $ (267,711) | $ (162,977) |
Cumulative dividends on redeemable convertible preferred stock | 0 | (3,481) | 0 | (6,962) |
Net loss | $ (135,054) | $ (94,082) | $ (267,711) | $ (169,939) |
Denominator: | ||||
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted | 329,176,107 | 65,938,939 | 328,994,058 | 65,686,290 |
Net loss per share attributable to common stockholders, basic and diluted (usd per share) | $ (0.41) | $ (1.43) | $ (0.81) | $ (2.59) |
Net Loss per Share - Common Sto
Net Loss per Share - Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 53,147,389 | 281,259,194 |
Redeemable convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 0 | 236,120,492 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 51,982,687 | 44,269,380 |
Restricted common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 90,808 | 410,607 |
Restricted common stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 1,073,894 | 458,715 |