Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 21, 2020 | Jun. 28, 2019 | |
Cover page. | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Transition Report | false | ||
Entity File Number | 001-36112 | ||
Entity Registrant Name | MACROGENICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 06-1591613 | ||
Entity Address, Address Line One | 9704 Medical Center Drive | ||
Entity Address, City or Town | Rockville | ||
Entity Address, State or Province | MD | ||
Entity Address, Postal Zip Code | 20850 | ||
City Area Code | 301 | ||
Local Phone Number | 251-5172 | ||
Title of 12(b) Security | Common stock, par value $0.01 per share | ||
Trading Symbol | MGNX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 829.7 | ||
Entity Common Stock, Shares Outstanding | 48,984,218 | ||
Documents Incorporated by Reference | Portions of MacroGenics, Inc.'s definitive proxy statement for the 2020 annual meeting of stockholders are incorporated by reference into Part III of this Annual Report. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001125345 | ||
Current Fiscal Year End Date | --12-31 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 126,472 | $ 220,128 |
Marketable securities | 89,284 | 12,735 |
Accounts receivable | 12,744 | 29,583 |
Prepaid expenses | 11,285 | 6,678 |
Total current assets | 239,785 | 269,124 |
Property, equipment and software, net | 48,211 | 56,712 |
Other assets | 24,505 | 6,294 |
Total assets | 312,501 | 332,130 |
Current liabilities: | ||
Accounts payable | 4,308 | 4,005 |
Accrued expenses | 27,139 | 33,196 |
Deferred revenue | 10,700 | 21,721 |
Deferred rent | 0 | 1,018 |
Lease Liabilities | 3,020 | 0 |
Total current liabilities | 45,167 | 59,940 |
Deferred revenue, net of current portion | 9,153 | 19,001 |
Lease liabilities, net of current portion | 27,553 | 0 |
Deferred rent, net of current portion | 0 | 10,312 |
Total liabilities | 81,873 | 89,253 |
Stockholders' equity: | ||
Common stock, $0.01 par value -- 125,000,000 shares authorized, 48,958,763 and 42,353,301 shares outstanding at December 31, 2019 and December 31, 2018, respectively | 490 | 424 |
Additional paid-in capital | 872,204 | 732,727 |
Accumulated other comprehensive loss | 16 | (3) |
Accumulated deficit | (642,082) | (490,271) |
Total stockholders' equity | 230,628 | 242,877 |
Total liabilities and stockholders' equity | $ 312,501 | $ 332,130 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 |
Common stock, shares outstanding (in shares) | 48,958,763 | 42,353,301 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | |||
Revenues | $ 64,188 | $ 60,121 | $ 157,742 |
Costs and expenses: | |||
Research and development | 195,309 | 190,827 | 147,232 |
General and administrative | 46,064 | 40,500 | 32,653 |
Total costs and expenses | 241,373 | 231,327 | 179,885 |
Loss from operations | (177,185) | (171,206) | (22,143) |
Other income | 25,374 | (247) | 2,517 |
Net loss | (151,811) | (171,453) | (19,626) |
Other comprehensive loss: | |||
Unrealized loss on investments | 19 | 58 | 21 |
Comprehensive loss | $ (151,792) | $ (171,395) | $ (19,605) |
Basic and diluted net loss per common share (in usd per share) | $ (3.16) | $ (4.19) | $ (0.54) |
Basic and diluted weighted average number of common shares | 48,082,728 | 40,925,318 | 36,095,080 |
Revenue from collaborative agreements | |||
Revenues: | |||
Revenues | $ 62,024 | $ 58,644 | $ 155,516 |
Revenue from government agreements | |||
Revenues: | |||
Revenues | $ 2,164 | $ 1,477 | $ 2,226 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Treasury Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Balance (in shares) at Dec. 31, 2016 | 34,870,607 | 0 | ||||
Balance at Dec. 31, 2016 | $ 268,751 | $ 349 | $ 0 | $ 561,198 | $ (292,714) | $ (82) |
Share-based compensation | 14,744 | 14,744 | ||||
Issuance of common stock, net of offering costs (in shares) | 1,699,284 | |||||
Issuance of common stock, net of offering costs | 34,244 | $ 17 | 34,227 | |||
Stock plan related activity (in shares) | 289,186 | 1,862 | ||||
Stock plan related activity | 1,104 | $ 3 | $ (40) | 1,141 | ||
Retirement of treasury stock (in shares) | (1,862) | |||||
Retirement of treasury stock | 0 | $ 40 | (40) | |||
Unrealized gain on investments | 21 | 21 | ||||
Net loss | (19,626) | (19,626) | ||||
Balance (in shares) at Dec. 31, 2017 | 36,859,077 | 0 | ||||
Balance at Dec. 31, 2017 | 299,238 | $ 369 | $ 0 | 611,270 | (312,340) | (61) |
Share-based compensation | 16,520 | 16,520 | ||||
Issuance of common stock, net of offering costs (in shares) | 5,175,000 | |||||
Issuance of common stock, net of offering costs | 103,259 | $ 52 | 103,207 | |||
Stock plan related activity (in shares) | 319,224 | 11,070 | ||||
Stock plan related activity | 1,733 | $ 3 | $ (260) | 1,990 | ||
Retirement of treasury stock (in shares) | (11,070) | |||||
Retirement of treasury stock | 0 | $ 260 | (260) | |||
Unrealized gain on investments | 58 | 58 | ||||
Net loss | (171,453) | (171,453) | ||||
Balance (in shares) at Dec. 31, 2018 | 42,353,301 | 0 | ||||
Balance at Dec. 31, 2018 | 242,877 | $ 424 | $ 0 | 732,727 | (490,271) | (3) |
Share-based compensation | 19,571 | 19,571 | ||||
Issuance of common stock, net of offering costs (in shares) | 6,325,000 | |||||
Issuance of common stock, net of offering costs | 118,657 | $ 63 | 118,594 | |||
Stock plan related activity (in shares) | 280,462 | 0 | ||||
Stock plan related activity | 1,315 | $ 3 | $ 0 | 1,312 | ||
Unrealized gain on investments | 19 | 19 | ||||
Net loss | (151,811) | (151,811) | ||||
Balance (in shares) at Dec. 31, 2019 | 48,958,763 | 0 | ||||
Balance at Dec. 31, 2019 | $ 230,628 | $ 490 | $ 0 | $ 872,204 | $ (642,082) | $ 16 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities | |||
Net loss | $ (151,811) | $ (171,453) | $ (19,626) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation and amortization expense | 10,845 | 8,279 | 7,228 |
Share-based compensation | 19,571 | 16,520 | 14,744 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 16,839 | (15,941) | (10,878) |
Prepaid expenses | (4,878) | (3,255) | 332 |
Other assets | (1,578) | (4,580) | 262 |
Accounts payable | 787 | 1,554 | (1,544) |
Accrued expenses | (6,057) | 3,506 | 12,832 |
Lease liabilities | 2,881 | 0 | 0 |
Deferred revenue | (20,869) | 13,405 | 6,533 |
Deferred rent | 0 | (971) | 6,115 |
Other liabilities | 0 | (298) | (1,593) |
Net cash provided by (used in) operating activities | (134,270) | (153,234) | 14,405 |
Cash flows from investing activities | |||
Purchases of marketable securities | (264,399) | (132,750) | (135,122) |
Proceeds from sales and maturities of marketable securities | 189,330 | 214,348 | 242,401 |
Purchases of property, equipment and software | (4,289) | (24,954) | (29,403) |
Net cash provided by (used in) investing activities | (79,358) | 56,644 | 77,876 |
Cash flows from financing activities | |||
Proceeds from issuance of common stock, net of offering costs | 118,657 | 103,259 | 34,244 |
Proceeds from stock option exercises and ESPP purchases | 1,315 | 1,992 | 1,144 |
Purchase of treasury stock | 0 | (260) | (40) |
Net cash provided by financing activities | 119,972 | 104,991 | 35,348 |
Net change in cash and cash equivalents | (93,656) | 8,401 | 127,629 |
Cash and cash equivalents at beginning of period | 220,128 | 211,727 | 84,098 |
Cash and cash equivalents at end of period | 126,472 | 220,128 | 211,727 |
Non-cash operating and investing activities: | |||
Right-of-use assets modified in exchange for operating lease obligation | 6,408 | 0 | 0 |
Fair value of warrants received | $ 0 | $ 6,130 | $ 0 |
Organization and Nature of Oper
Organization and Nature of Operations | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Nature of Operations | Organization and Nature of OperationsMacroGenics, Inc. (the Company) is incorporated in the state of Delaware. The Company is a biopharmaceutical company focused on discovering and developing innovative antibody-based therapeutics designed to modulate the human immune response for the treatment of cancer. The Company currently has a pipeline of investigational product candidates in human clinical testing that have been created primarily using its proprietary, antibody-based technology platforms. The Company believes its programs have the potential to have a meaningful effect on treating patients' unmet medical needs as monotherapy or, in some cases, in combination with other therapeutic agents. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, MacroGenics UK Limited and MacroGenics Limited. All intercompany accounts and transactions have been eliminated in consolidation. The Company currently operates in one operating segment. Operating segments are defined as components of an enterprise about which separate discrete information is available for the chief operating decision maker, or decision making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business in one segment, which is developing monoclonal antibody-based therapeutics for cancer, autoimmune and infectious diseases. Use of Estimates The preparation of the financial statements in accordance with generally accepted accounting principles (GAAP) requires the Company to make estimates and judgments in certain circumstances that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. In preparing these consolidated financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements, giving due consideration to materiality. On an ongoing basis, the Company evaluates its estimates, including those related to revenue recognition, fair values of assets, stock-based compensation, income taxes, preclinical study and clinical trial accruals and other contingencies. Management bases its estimates on historical experience or on various other assumptions that it believes to be reasonable under the circumstances. Actual results could differ from these estimates. Cash, Cash Equivalents and Marketable Securities The Company considers all investments in highly liquid financial instruments with a maturity of 90 days or less at the date of purchase to be cash equivalents. Cash and cash equivalents includes investments in money market funds with commercial banks and financial institutions, securities issued by the U.S. government and its agencies, Government Sponsored Enterprise agency debt obligations and corporate debt obligations. Cash equivalents are stated at amortized cost, plus accrued interest, which approximates fair value. The Company carries marketable securities classified as available-for-sale at fair value as determined by prices for identical or similar securities at the balance sheet date. Marketable securities consist of Level 2 financial instruments in the fair-value hierarchy. The Company records unrealized gains and losses as a component of other comprehensive loss within the statements of operations and comprehensive loss and as a separate component of stockholders' equity. Realized gains or losses on available-for-sale securities are determined using the specific identification method and the Company includes net realized gains and losses in other income (expense). At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the unrealized loss is other-than-temporary. The Company considers factors including: the significance of the decline in value compared to the cost basis, underlying factors contributing to a decline in the prices of securities in a single asset class, the length of time the market value of the security has been less than its cost basis, the security's relative performance versus its peers, sector or asset class, expected market volatility and the market and economy in general. The Company also evaluates whether it is more likely than not that it will be required to sell a security prior to recovery of its fair value. An impairment loss is recognized at the time the Company determines that a decline in the fair value below its cost basis is other-than-temporary. There were no unrealized losses at December 31, 2019 or 2018 that the Company determined to be other-than-temporary. Accounts Receivable Accounts receivable that management has the intent and ability to collect are reported in the consolidated balance sheets at outstanding amounts, less an allowance for doubtful accounts. The Company writes off uncollectible receivables when the likelihood of collection is remote. The Company evaluates the collectability of accounts receivable on a regular basis. The allowance, if any, is based upon various factors including the financial condition and payment history of customers, an overall review of collections experience on other accounts and economic factors or events expected to affect future collections experience. No allowance was recorded as of December 31, 2019 or 2018, as the Company has a history of collecting on all outstanding accounts. Fair Value of Financial Instruments The Company's financial instruments consist of cash and cash equivalents, marketable securities, accounts receivable, accounts payable and accrued expenses. The carrying amount of accounts receivable, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of their short-term nature. The Company accounts for recurring and non-recurring fair value measurements in accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 820, Fair Value Measurements and Disclosures (ASC 820). ASC 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value, and requires expanded disclosures about fair value measurements. The ASC 820 hierarchy ranks the quality of reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories: • Level 1 – Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. • Level 2 – Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. • Level 3 – Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity – e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC 820 hierarchy. Financial assets measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurement at December 31, 2019 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total Level 1 Level 2 Level 3 Assets: Money market funds $ 46,149 $ 46,149 $ — $ — Government-sponsored enterprises 13,222 — 13,222 — Corporate debt securities 103,135 — 103,135 — Total assets measured at fair value (a) $ 162,506 $ 46,149 $ 116,357 $ — Fair Value Measurement at December 31, 2018 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total Level 1 Level 2 Level 3 Assets: Money market funds $ 46,257 $ 46,257 $ — $ — U.S Treasury securities 12,488 — 12,488 — Corporate debt securities 100,214 — 100,214 — Common stock warrants 1,890 — — $ 1,890 Total assets measured at fair value (b) $ 160,849 $ 46,257 $ 112,702 $ 1,890 (a) Total assets measured at fair value at December 31, 2019 includes approximately $73.2 million reported in cash and cash equivalents on the balance sheet. (b) Total assets measured at fair value at December 31, 2018 includes approximately $146.2 million reported in cash and cash equivalents on the balance sheet. The fair value of Level 2 securities is determined from market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data. The fair value of Level 3 securities is determined using the Black-Scholes option-pricing model. There were no transfers between levels during the periods presented. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, marketable securities and accounts receivable. The Company maintains its cash and money market funds with financial institutions that are federally insured. While balances deposited in these institutions often exceed Federal Deposit Insurance Corporation limits, the Company has not experienced any losses on related accounts to date. The Company's investment policy limits investments to certain types of debt securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The counterparties are various corporations, financial institutions and government agencies of high credit standing. The Company's revenue relates to agreements with various collaborators and contracts and research grants received from U.S. government agencies. The following table includes those collaborators that represent more than 10% of total revenue earned in the periods indicated: Year Ended December 31, 2019 2018 2017 Incyte Corporation (Incyte) 35% 68% 96% Zai Lab Limited (Zai Lab) 29% * * Les Laboratoires Servier and Institut de Recherches Servier (Servier) 18% * * * Balance is less than 10% The following table includes those counterparties that represent more than 10% of accounts receivable at the date indicated: December 31, 2019 2018 Incyte 62% 16% Zai Lab 23% 76% Property, Equipment and Software Property, equipment and software are stated at cost. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation or amortization are removed from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Computer equipment 3 years Software 3 years Furniture 10 years Laboratory and office equipment 5 years Leasehold improvements Shorter of lease term or useful life Impairment of Long-Lived Assets The Company assesses the recoverability of its long-lived assets in accordance with the provisions of ASC 360, Property, Plant and Equipment (ASC 360). ASC 360 requires that long-lived assets be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset or asset group. If carrying value exceeds the sum of undiscounted cash flows, the Company then determines the fair value of the underlying asset group. Any impairment to be recognized is measured by the amount by which the carrying amount of the asset group exceeds the estimated fair value of the asset group. Assets to be disposed of are reported at the lower of the carrying amount or fair value, less costs to sell. For the years ended December 31, 2019, 2018 and 2017, the Company determined that there were no impaired assets. Income Taxes Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income in the period that such tax rate changes are enacted. The measurement of a deferred tax asset is reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured as the largest amount that is more likely than not to be realized upon ultimate settlement. The Company's policy is to record interest and penalties related to uncertain tax positions as a component of income tax expense. Revenues Beginning on January 1, 2018, the Company recognizes revenue under Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customer s and all related amendments (collectively ASC 606) 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. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company enters into licensing agreements that are within the scope of ASC 606, under which it may license rights to research, develop, manufacture and commercialize its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; reimbursement of certain costs; customer option exercise fees; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products. The Company may also enter into development and manufacturing service agreements with its collaborators. For each arrangement that results in revenues, the Company identifies all performance obligations, which may include a license to intellectual property and know-how, research and development activities, transition activities and/or manufacturing services. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required. Once the estimated transaction price is established, amounts are allocated to the performance obligations that have been identified. The transaction price is generally allocated to each separate performance obligation on a relative standalone selling price basis. The Company must develop assumptions that require judgment to determine the standalone selling price in order to account for these agreements. To determine the standalone selling price, the Company’s assumptions may include (i) the probability of obtaining marketing approval for the product candidate, (ii) estimates regarding the timing and the expected costs to develop and commercialize the product candidate, and (iii) estimates of future cash flows from potential product sales with respect to the product candidate. Standalone selling prices used to perform the initial allocation are not updated after contract inception. The Company does not include a financing component to its estimated transaction price at contract inception unless it estimates that certain performance obligations will not be satisfied within one year. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Licenses. If the license to the Company’s intellectual property is determined to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and when (or as) the customer is able to use and benefit from the license. In assessing whether a promise or performance obligation is distinct from the other promises, the Company considers factors such as the research, development, manufacturing and commercialization capabilities of the licensee and the availability of the associated expertise in the general marketplace. In addition, the Company considers whether the licensee can benefit from a promise for its intended purpose without the receipt of the remaining promise, whether the value of the promise is dependent on the unsatisfied promise, whether there are other vendors that could provide the remaining promise, and whether it is separately identifiable from the remaining promise. For licenses that are combined with other promises, the Company utilizes 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. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The measure of progress, and thereby periods over which revenue should be recognized, are subject to estimates by management and may change over the course of the research and development and licensing agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Research, Development and/or Manufacturing Services. The promises under the Company’s agreements may include research and development or manufacturing services to be performed by the Company on behalf of the counterparty. If these services are determined to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to these services as revenue over time based on an appropriate measure of progress when the performance by the Company does not create an asset with an alternative use and the Company has an enforceable right to payment for the performance completed to date. If these services are determined not to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the combined performance obligation as the related performance obligations are satisfied. Customer Options. If an arrangement contains customer options, the Company evaluates whether the options are material rights because they allow the customer to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. The Company allocates the transaction price to material rights based on the relative standalone selling price, which is determined based on the identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised. If the options are deemed not to be a material right, they are excluded as performance obligations at the outset of the arrangement. Milestone Payments. At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Royalties. For arrangements that include sales-based royalties which are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. The Company analyzes its collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties who are both active participants in the activities and are both exposed to significant risks and rewards dependent on the commercial success of such activities. Such arrangements generally are within the scope of ASC 808, Collaborative Arrangements (ASC 808). While ASC 808 defines collaborative arrangements and provides guidance on income statement presentation, classification, and disclosures related to such arrangements, it does not address recognition and measurement matters, such as (1) determining the appropriate unit of accounting or (2) when the recognition criteria are met. Therefore, the accounting for these arrangements is either based on an analogy to other accounting literature or an accounting policy election by the Company. The Company accounts for certain components of the collaboration agreement that are reflective of a vendor-customer relationship (e.g., licensing arrangement) based on an analogy to ASC 606. The Company accounts for other components based on a reasonable, rational and consistently applied accounting policy election. Reimbursements from the counter-party that are the result of a collaborative relationship with the counter-party, instead of a customer relationship, such as co-development activities, are recorded as a reduction to research and development expense as the services are performed. For a complete discussion of accounting for revenue from collaborative and other agreements, see Note 9, Collaboration and Other Agreements. Research and Development Costs, Including Clinical Trial Accruals/Expenses Research and development expenditures are expensed as incurred. Research and development costs primarily consist of employee related expenses, including salaries and benefits, expenses incurred under agreements with contract research organizations (CROs), investigative sites and consultants that conduct the Company's clinical trials, the cost of acquiring and manufacturing clinical trial materials, including costs incurred under agreements with contract manufacturing organizations (CMOs), and other allocated expenses, license fees for and milestone payments related to in-licensed products and technologies, stock-based compensation expense, and costs associated with non-clinical activities and regulatory approvals. Right-to-develop agreements may contain cost-sharing provisions whereby the Company and the collaborator share the cost of research and development activities. Reimbursement of research and development expenses received in connection with these agreements is recorded as a reduction of such expenses. Clinical trial expenses are a significant component of research and development expenses, and the Company outsources a significant portion of these costs to third parties. Third party clinical trial expenses include investigator fees, site and patient costs, clinical research organization (CRO) costs, costs for central laboratory testing, data management and CMO costs. The accrual for site and patient costs includes inputs such as estimates of patient enrollment, patient cycles incurred, clinical site activations, and other pass-through costs. These inputs are required to be estimated due to a lag in receiving the actual clinical information from third parties. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as a prepaid asset or accrued expenses. These third party agreements are generally cancellable, and related costs are recorded as research and development expenses as incurred . Non-refundable advance clinical payments for goods or services that will be used or rendered for future research and development activities are recorded as a prepaid asset and recognized as expense as the related goods are delivered or the related services are performed. When evaluating the adequacy of the accrued expenses, management analyzes progress of the studies, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the estimates made. The historical clinical accrual estimates have not been materially different from the actual costs. Stock-based Compensation Stock-based payments are accounted for in accordance with the provisions of ASC 718, Compensation – Stock Compensation . The fair value of stock-based payments is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. For awards that contain a performance condition, expense is amortized using the accelerated attribution method. Recognition of stock-based compensation expense is based on the value of the portion of stock-based awards that is ultimately expected to vest during the period. The Company utilizes the Black-Scholes model for estimating fair value of its stock options granted. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. Comprehensive Loss Comprehensive loss represents net loss adjusted for the change during the periods attributed to unrealized gains and losses on available-for-sale debt securities. Net Loss Per Share Basic and diluted loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. All stock options and restricted stock units (RSUs) are excluded from the per share calculations as such securities were anti-dilutive for all periods presented. The following table presents the number of stock options and RSUs that were excluded from the calculation of net loss per share: Year Ended December 31, 2019 2018 2017 Stock options and RSUs 7,159,494 5,273,964 4,504,642 Recently Adopted Accounting Standards In May 2014, the FASB issued ASC 606. The Company adopted ASC 606 on January 1, 2018 using the modified retrospective method for all contracts that were not completed as of January 1, 2018. For contracts that were modified before the effective date, the Company reflected the aggregate effect of all modifications when identifying performance obligations and allocating transaction price in accordance with available practical expedients. Comparative prior period information continues to be reported under the accounting standards in effect for the period presented. As a result of applying the modified retrospective method to adopt the new guidance, the following adjustments were made to accounts on the consolidated balance sheet as of January 1, 2018 (in thousands): Pre-Adoption ASC 606 Adjustment Post-Adoption Deferred revenue, current $ 7,202 $ 540 $ 7,742 Deferred revenue, net of current portion 13,637 5,939 19,576 Accumulated deficit (312,340) (6,478) (318,818) The transition adjustment resulted primarily from changes in the pattern of revenue recognition for upfront fees and license grant fees. The following table shows the impact of adoption to the consolidated statement of income and balance sheet (in thousands): Year Ended December 31, 2018 As Reported Balances Without Adoption of ASC 606 Effect of Change Higher/(Lower) Revenue from collaborative agreements $ 58,644 $ 58,104 $ 540 Net loss (171,453) (171,993) (540) Basic and diluted net loss per common share $ (4.19) $ (4.20) $ 0.01 As of December 31, 2018 As Reported Balances Without Adoption of ASC 606 Effect of Change Higher/(Lower) Deferred revenue, current $ 21,721 $ 22,210 $ (489) Deferred revenue, net of current portion 19,001 12,573 6,428 Accumulated deficit (490,271) $ (484,332) $ (5,939) The following table presents changes in the Company’s contract liabilities during the year ended December 31, 2018 (in thousands): Balance at Beginning of Period Additions Deductions Balance at End of Period Deferred revenue (current and non-current) $ 27,318 $ 22,992 $ (9,588) $ 40,722 During the year ended December 31, 2018, the Company recognized $9.6 million in revenue as a result of changes in the contract liability balance. In February 2016, the FASB issued ASU 2016-02, which requires lessees to recognize a right-of-use (ROU) asset and a lease liability for all leases with terms greater than 12 months and also requires disclosures by lessees and lessors about the amount, timing and uncertainty of cash flows arising from leases. Subsequent to the issuance of ASU 2016-02, the FASB clarified the guidance through several ASUs, with the resulting guidance collectively referred to as ASC 842. The Company adopted ASC 842 effective January 1, 2019, using the optional transition method provided under ASU 2018-11, which did not require adjustments to comparative periods nor require modified disclosures in those comparative periods. The Company has elected not to recognize leases with terms of one year or less on the ba |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities Available-for-sale marketable securities as of December 31, 2019 and 2018 were as follows (in thousands): December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Government-sponsored enterprises $ 13,216 $ 6 $ — $ 13,222 Corporate debt securities 76,052 20 (10) 76,062 Total $ 89,268 $ 26 $ (10) $ 89,284 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate debt securities $ 12,738 $ — $ (3) $ 12,735 All of the Company's available-for-sale securities held at December 31, 2019 and 2018 had maturity dates of less than one year. All available-for-sale securities in an unrealized loss position as of December 31, 2019 and 2018 were in a loss position for less than twelve months. There were no unrealized losses at December 31, 2019 or 2018 that the Company determined to be other-than-temporary. The Company recorded interest income of $3.4 million, $2.3 million and $2.4 million during the years ended December 31, 2019, 2018 and 2017, respectively, which is included in Other income (expense) on the consolidated statements of operations and comprehensive loss. |
Property, Equipment and Softwar
Property, Equipment and Software | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property, Equipment and Software | Property, Equipment and Software Property, equipment and software consists of the following (in thousands): December 31, 2019 2018 Computer equipment $ 2,430 $ 2,360 Software 7,513 7,011 Furniture and office equipment 713 668 Motor Vehicles 50 — Lab equipment 38,368 36,062 Leasehold improvements 48,675 48,328 Construction in progress 187 218 Property, equipment and software 97,936 94,647 Less accumulated depreciation and amortization (49,725) (37,935) Property, equipment and software, net $ 48,211 $ 56,712 There was $0.1 million in property, equipment and software at December 31, 2019 that was purchased in 2019 but was not paid for by year end. The property, equipment and software balance at December 31, 2018 includes approximately $0.6 million in assets that were purchased in 2018 but were not paid for by year end. Depreciation and amortization expense related to property, equipment and software for the years ended December 31, 2019, 2018 and 2017 was $12.3 million, $9.2 million and $7.0 million, respectively. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | Leases The Company has non-cancelable operating leases for manufacturing, laboratory and office space in Rockville, Maryland and a non-cancelable operating lease for laboratory and office space in Brisbane, California. A portion of the space under one of these leases is subleased to a third party. All but one of these leases include one or more options to renew, with those renewal periods ranging from five fourteen Upon adoption of ASC 842 on January 1, 2019, it was not reasonably certain that the Company would extend any of its operating leases, therefore the options to extend the lease terms were not recognized as part of the ROU assets or lease liabilities. During the year ended December 31, 2019, the Company exercised the options to extend two leases for an additional five year ended December 31, 2019 . As of December 31, 2019, the Company’s ROU assets were valued at $20.2 million and are included in Other assets on the consolidated balance sheet. The components of lease cost for the year ended December 31, 2019 were as follows (in thousands): Operating lease cost $ 5,463 Variable lease cost 1,366 Sublease income (942) Net lease cost $ 5,887 As of December 31, 2019 , the maturities of our operating lease liabilities were as follows (in thousands): 2020 5,913 2021 6,507 2022 6,688 2023 6,536 2024 5,588 Thereafter 11,068 Total lease payments 42,300 Present value adjustment (11,727) Lease liabilities $ 30,573 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity The Company's amended and restated certificate of incorporation authorizes 125,000,000 shares of common stock, and 5,000,000 shares of undesignated preferred stock, both with a par value of $.01 per share. There were no shares of undesignated preferred stock issued or outstanding as of December 31, 2019 or 2018. In April 2017, the Company entered into a definitive agreement with an institutional healthcare investor to purchase 1,100,000 shares of its common stock at a purchase price of $21.50 per share in a registered direct offering. Proceeds to the Company, before deducting estimated offering expenses, were $23.7 million. The shares were offered pursuant to the Company’s effective shelf registration on Form S-3 that was filed with the Securities and Exchange Commission (SEC) on November 2, 2016. In May 2017, the Company entered into a sales agreement with an agent to sell, from time to time, shares of its common stock having an aggregate sales price of up to $75.0 million through an “at the market offering” (ATM Offering) as defined in Rule 415 under the Securities Act of 1933, as amended. The shares that may be sold under the sales agreement would be issued and sold pursuant to the Company's shelf registration statement on Form S-3 that was filed with the SEC on November 2, 2016. During the year ended December 31, 2017, the Company sold 599,284 shares of common stock resulting in net proceeds of approximately $10.8 million related to the ATM Offering. In April 2018, the Company completed a firm-commitment underwritten public offering, in which the Company sold 4,500,000 shares of its common stock at a price of $21.25 per share. Additionally, the underwriters of the offering exercised the full amount of their over-allotment option resulting in the sale of an additional 675,000 shares of the Company's common stock at a price of $21.25 per share. Upon closing, the Company received net proceeds of approximately $103.3 million from this offering, net of underwriting discounts and commissions and other offering expenses. In February 2019, the Company completed a firm-commitment underwritten public offering, in which the Company sold 5,500,000 shares of its common stock at a price of $20.00 per share. Additionally, the underwriters of the offering exercised the full amount of their over-allotment option resulting in the sale of an additional 825,000 shares of the Company’s common stock at a price of $20.00 per share. The Company received net proceeds of approximately $118.7 million from this offering, net of underwriting discounts and commissions and other offering expenses. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | Stock-based Compensation Employee Stock Purchase Plan In May 2017, the Company’s stockholders approved the 2016 Employee Stock Purchase Plan (the 2016 ESPP). The 2016 ESPP is structured as a qualified employee stock purchase plan under Section 423 of the Internal Revenue Code of 1986, as amended, and is not subject to the provisions of the Employee Retirement Income Security Act of 1974. The Company reserved 800,000 shares of common stock for issuance under the 2016 ESPP. The 2016 ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 10% of their eligible compensation, subject to any plan limitations. The 2016 ESPP provides for six-month offering periods ending on May 31 and November 30 of each year. At the end of each offering period, employees are able to purchase shares at 85% of the fair market value of the Company’s common stock on the last day of the offering period. During the year ended December 31, 2019, employees purchased 61,417 shares of common stock under the 2016 ESPP for net proceeds to the Company of approximately $0.7 million. Employee Stock Incentive Plans Effective February 2003, the Company implemented the 2003 Equity Incentive Plan (2003 Plan), and it was amended and approved by the Company's stockholders in 2005. Stock options granted under the 2003 Plan may be either incentive stock options as defined by the Internal Revenue Code (IRC), or non-qualified stock options. In 2013, the 2003 Plan was terminated, and no further awards may be issued under the plan. Any shares of common stock subject to awards under the 2003 Plan that expire, terminate, or are otherwise surrendered, canceled, forfeited or repurchased without having been fully exercised, or resulting in any common stock being issued, will become available for issuance under the 2013 Stock Incentive Plan (2013 Plan), up to a specified number of shares. As of December 31, 2019, under the 2003 Plan, there were options to purchase an aggregate of 550,572 shares of common stock outstanding at a weighted average exercise price of $2.32 per share. In October 2013, the Company implemented the 2013 Plan. The 2013 Plan provides for the grant of stock options and other stock-based awards, as well as cash-based performance awards. The aggregate number of shares of common stock initially available for issuance pursuant to awards under the 2013 Plan was 1,960,168 shares. The number of shares of common stock reserved for issuance will automatically increase on January 1 of each year from January 1, 2014 through and including January 1, 2023, by the lesser of (a) 1,960,168 shares, (b) 4.0% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, or (c) the number of shares of common stock determined by the Board of Directors. During the year ended December 31, 2019, the maximum number of shares of common stock authorized to be issued by the Company under the 2013 Plan was increased to 9,932,263. If an option expires or terminates for any reason without having been fully exercised, if any shares of restricted stock are forfeited, or if any award terminates, expires or is settled without all or a portion of the shares of common stock covered by the award being issued, such shares are available for the grant of additional awards. However, any shares that are withheld (or delivered) to pay withholding taxes or to pay the exercise price of an option are not available for the grant of additional awards. As of December 31, 2019, under the 2013 Plan, there were options to purchase an aggregate of 6,156,422 shares of common stock outstanding at a weighted average exercise price of $24.12 per share. The following stock-based compensation amounts were recognized for the periods indicated (in thousands): Year Ended December 31, 2019 2018 2017 Research and development $ 10,023 $ 7,919 $ 7,388 General and administrative 9,548 8,601 7,356 Total stock-based compensation expense $ 19,571 $ 16,520 $ 14,744 Employee Stock Options The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions in the following table: Year Ended December 31, 2019 2018 2017 Expected dividend yield 0% 0% 0% Expected volatility 74% - 76% 68% - 72% 67% - 68% Risk-free interest rate 1.4% - 2.6% 2.4% - 3.1% 1.9% - 2.3% Expected term 6.25 years 6.25 years 6.25 years Expected Dividend Yield – The Company has never declared or paid dividends and has no plans to do so in the foreseeable future. Expected Volatility – Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. As the Company does not yet have sufficient history of its own volatility, the Company has identified several public entities of similar size, complexity and stage of development and estimates volatility based on the volatility of these companies. Risk-Free Interest Rate – This is the U.S. Treasury rate for the week of each option grant during the year, having a term that most closely resembles the expected life of the option. Expected Term – This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of ten years. The Company uses a simplified method to calculate the average expected term. In addition to the assumptions above, the Company estimates the forfeiture rate based on turnover data with further consideration given to the class of the employees to whom the options were granted. The forfeiture rate is the estimated percentage of options granted that is expected to be forfeited or canceled on an annual basis before becoming fully vested. The following table summarizes stock option activity for 2019: Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in thousands) Outstanding, December 31, 2018 5,273,964 $ 22.23 6.8 Granted 1,946,770 20.81 Exercised (219,045) 3.03 Forfeited or expired (294,695) 24.72 Outstanding, December 31, 2019 6,706,994 22.33 6.9 $ 4,749 December 31, 2019: Exercisable 4,298,178 22.21 5.9 4,712 Vested and expected to vest 6,446,218 22.31 6.9 4,746 During 2019, 2018 and 2017 the Company issued 219,045, 274,362 and 253,036 net shares of common stock, respectively, in conjunction with stock option exercises. The Company received cash proceeds from the exercise of stock options of approximately $0.7 million, $0.9 million and $0.5 million during 2019, 2018 and 2017, respectively. The weighted-average grant-date fair value of options granted during 2019, 2018 and 2017 was $13.98, $17.90 and $12.53 per share, respectively. The total intrinsic value of options exercised during 2019, 2018 and 2017 was approximately $2.9 million, $5.2 million and $4.2 million, respectively. The total fair value of stock options which vested during 2019, 2018 and 2017 was $17.7 million, $16.4 million and $14.6 million, respectively. As of December 31, 2019, the total unrecognized compensation expense related to non-vested stock options, net of related forfeiture estimates, was $30.2 million, which the Company expects to recognize over a weighted-average period of approximately 2.6 years. Restricted Stock Units During 2019, the Company awarded RSUs under the 2013 Plan to all employees except executive officers and employees with less than six months of service as of the grant date. Each RSU entitles the holder to receive one share of the Company's common stock when the RSU vests. The RSUs vest in two equal installments on the first and second anniversary of the grant date. Compensation expense is recognized on a straight-line basis. No RSUs were granted during the years ended December 31, 2018 and 2017. The following table summarizes RSU activity for 2019: Shares Weighted-Average Grant Date Fair Value Outstanding, December 31, 2018 — — Granted 467,600 $ 15.32 Exercised — — Forfeited or expired (15,100) 15.32 Outstanding, December 31, 2019 452,500 15.32 At December 31, 2019, there was $5.3 million of total unrecognized compensation cost related to unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of 1.6 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes For the years ended December 31, 2019, 2018 and 2017 there was no provision for income taxes due to taxable losses generated, fully offset by a valuation allowance. The significant components of the Company's deferred income tax assets (liabilities) were as follows (in thousands): December 31, 2019 2018 Deferred income tax assets: Federal U.S. net operating loss carryforward $ 116,436 $ 87,284 State net operating loss carryforward 31,110 22,809 Research and development credit, net 35,580 29,750 Orphan drug credit, net 22,881 22,580 Operating lease liabilities 8,413 — Deferred revenue 367 3,736 Other 9,123 9,972 Gross deferred income tax assets 223,910 176,131 Valuation allowance (214,893) (172,457) Net deferred income tax assets 9,017 3,674 Deferred income tax liabilities: Depreciation (438) (1,911) Operating lease ROU assets (5,547) — Prepaid expenditures (3,032) (1,763) Gross deferred income tax liabilities (9,017) (3,674) Net deferred income tax asset/(liability) $ — $ — The Company recognizes valuation allowances to reduce deferred tax assets to the amount that is more likely than not to be realized. In assessing the likelihood of realization, management considers (i) future reversals of existing taxable temporary differences; (ii) future taxable income exclusive of reversing temporary difference and carryforwards; (iii) taxable income in prior carryback years if carryback is permitted under applicable tax law; and (iv) tax planning strategies. The Company's net deferred income tax asset is not more likely than not to be utilized due to the lack of sufficient sources of future taxable income and cumulative book losses which have resulted over the years. As of December 31, 2019, the Company has U.S. federal and state net operating loss (NOL) carryforwards of approximately $554.5 million. Of these NOLs, $237.8 million will expire in various years beginning in 2025 through 2037. $316.7 million of NOLs were generated post December 31, 2017 and carryforward indefinitely. In addition, the Company has U.S. federal tax credits of $58.2 million which will expire in various years beginning in 2022 through 2039. The use of the Company's U.S. federal NOL and tax credit carryforwards in future years are restricted due to changes in the Company's ownership and tax attributes acquired through the Company's acquisitions. As of December 31, 2019, $13.5 million of the Company's U.S. Federal NOLs are limited for use over the years 2020 – 2028 in which a range of such amounts could be utilized on an annual basis of $0.2 million to $1.4 million. The remaining $541.0 million of NOLs is not limited and can be offset against future taxable income, subject to certain limitations for newly enacted tax legislation. The reconciliation of the reported estimated income tax benefit to the amount that would result by applying the U.S. federal statutory tax rate to the net income is as follows (in thousands): Year Ended December 31, 2019 2018 2017 United States federal tax at statutory rate $ (31,880) $ (36,005) $ (6,869) State taxes (net of federal benefit) (9,524) (11,133) (735) Deferred income tax adjustments 2,004 (4,435) 607 Deferred state blended rate adjustments — — (485) Deferred federal rate change reduction in corporate rate — — 39,447 Research credit, net (5,830) (8,466) (8,455) Orphan drug credit, net (301) (872) (1,853) Other permanent items 1,206 148 276 Equity-based compensation 1,889 758 2,067 Change in valuation allowance 42,436 60,005 (24,000) Income tax expense/(benefit) $ — $ — $ — A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2019 2018 2017 Beginning balance $ 4,318 $ 3,395 $ 2,465 Increases for current year tax positions 637 642 569 Increases/(decreases) for prior year tax positions (5) 281 361 Ending balance $ 4,950 $ 4,318 $ 3,395 As of December 31, 2019 and 2018, of the total gross unrecognized tax benefits, approximately $4.9 million and $4.3 million would favorably impact the Company's effective income tax rate, respectively. Although, due to the Company's determination that the deferred income tax asset would not more likely than not be realized, a valuation allowance would be recorded, therefore, zero net impact would result within the Company's effective income tax rate. The Company's uncertain income tax position liability has been recorded to deferred income taxes to offset the tax attribute carryforward amounts. For the years ended December 31, 2019, 2018 and 2017, the Company has not recognized any interest or penalties related to the uncertain income tax positions due to the fact such position is related to tax attribute carryforwards which have not yet been utilized. The Company does not expect its unrecognized income tax position to significantly decrease within the next twelve months. The Company's U.S. Federal and state income tax returns from 2001 forward remain open to examination due to the carryover of unused net operating losses and tax credits. |
Collaboration and Other Agreeme
Collaboration and Other Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Collaboration and License Agreements [Abstract] | |
Collaboration and Other Agreements | Collaboration and Other Agreements Incyte In October 2017, the Company entered into an exclusive global collaboration and license agreement with Incyte for MGA012 (also known as INCMGA0012), an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1) (Incyte License Agreement). Incyte has obtained exclusive worldwide rights for the development and commercialization of MGA012 in all indications, while the Company retains the right to develop its pipeline assets in combination with MGA012. Under the terms of the Incyte License Agreement, Incyte paid the Company an upfront payment of $150.0 million in 2017. Under the terms of the Incyte License Agreement, Incyte will lead global development of MGA012. Assuming successful development and commercialization by Incyte, the Company could receive up to approximately $420.0 million in development and regulatory milestones, and up to $330.0 million in commercial milestones. As of December 31, 2019, the Company has recognized $15.0 million in development milestones under this agreement. If commercialized, the Company would be eligible to receive tiered royalties of 15% to 24% on any global net sales. The Company retains the right to develop its pipeline assets in combination with MGA012, with Incyte commercializing MGA012 and the Company commercializing its asset(s), if any such potential combinations are approved. In addition, the Company retains the right to manufacture a portion of both companies' global commercial supply needs of MGA012, subject to a separate commercial supply agreement to be negotiated. Finally, Incyte funded the Company's activities related to the ongoing monotherapy clinical study and will continue to fund certain related clinical activities. Upon the adoption of ASC 606 on January 1, 2018, the Company evaluated the Incyte Agreement under the provisions of ASC 606 and identified the following two performance obligations under the agreement: (i) the license of MGA012 and (ii) the performance of certain clinical activities through a brief technology transfer period. The Company determined that the license and clinical activities are separate performance obligations because they are capable of being distinct, and are distinct in the context of the contract. The license has standalone functionality as it is sublicensable, Incyte has significant capabilities in performing clinical trials, and Incyte is capable of performing these activities without the Company's involvement; the Company performed the activities during the transfer period as a matter of convenience. The Company determined that the transaction price of the Incyte Agreement at inception was $154.0 million, consisting of the consideration to which the Company was entitled in exchange for the license and an estimate of the consideration for clinical activities to be performed. The transaction price was allocated to each performance obligation based on their relative standalone selling price. The standalone selling price of the license was determined using the adjusted market assessment approach considering similar collaboration and license agreements. The standalone selling price for agreed-upon clinical activities to be performed was determined using the expected cost approach based on similar arrangements the Company has with other parties. The potential development and regulatory milestone payments are fully constrained until the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods, and as such have been excluded from the transaction price. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur, as they were determined to relate predominantly to the license granted to Incyte and, therefore, have also been excluded from the transaction price. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. During the year ended December 31, 2018, it became probable that a significant reversal of cumulative revenue would not occur for three development milestones totaling $15.0 million related to MGA012 meeting certain clinical proof-of-concept criteria. Therefore the associated consideration was added to the estimated transaction price and was recognized as revenue. During the year ended December 31, 2019 there were no adjustments to the transaction price of the Incyte Agreement. The Company recognized the $150.0 million allocated to the license when it satisfied its performance obligation and transferred the license to Incyte in 2017. The $4.0 million allocated to the clinical activities was recognized over the period from the effective date of the agreement until such time as the clinical activities were transferred to Incyte using an input method according to research and development costs incurred to date compared to estimated total research and development costs. These clinical activities were substantially completed in 2018. Prior to the adoption of ASC 606 on January 1, 2018, the accounting for this agreement did not materially differ from the accounting under ASC 606. The Company recognized revenue of $0.1 million and $18.8 million under the Incyte Agreement during the years ended December 31, 2019 and 2018, respectively. The revenue recognized during the year ended December 31, 2018 included milestone revenue of $15.0 million. The Company also has an agreement with Incyte, which was entered into in 2018, under which the Company is to perform development and manufacturing services for Incyte’s clinical needs of MGA012 (Incyte Clinical Supply Agreement). The Company evaluated this agreement under ASC 606 and identified one performance obligation under the agreement: to perform services related to the development and manufacturing of the clinical supply of MGA012. The transaction price is based on the costs incurred to develop and manufacture drug product and drug substance, and is recognized over time as the services are provided, as the performance by the Company does not create an asset with an alternative use and the Company has an enforceable right to payment for the performance completed to date. During the years ended December 31, 2019 and 2018, the Company recognized revenue of $22.1 million and $22.2 million, respectively, for services performed under this agreement. Servier In September 2012, the Company entered into a collaboration agreement with Servier and granted it exclusive options to obtain three separate exclusive licenses to develop and commercialize DART molecules, consisting of those designated by the Company as flotetuzumab (also known as MGD006 or S80880) and MGD007, as well as a third DART molecule, in all countries other than the United States, Canada, Mexico, Japan, South Korea and India (Servier Agreement). In 2014, Servier exercised its exclusive option to develop and commercialize flotetuzumab. During the term of the agreement, Servier did not exercise its options for either MGD007 or the third DART molecule. In July 2019, Servier informed the Company of its intention to terminate the Servier Agreement and the agreement was terminated effective January 15, 2020. As a result of this termination, the Company will regain full exclusive, worldwide commercialization rights to develop and market flotetuzumab. Upon execution of the agreement, Servier made a nonrefundable payment of $20.0 million to the Company. The Company evaluated the Servier Agreement under the provisions of ASC 606 and concluded that Servier is a customer prior to the exercise of any of the three options. The Company identified the following material promises under the arrangement for each of the three molecules: (i) a limited evaluation license to conduct activities under the research plan and (ii) research and development services concluding with an option trigger data package. The Servier Agreement also provided exclusive options for an exclusive license to research, develop, manufacture and commercialize each subject molecule. The Company evaluated these options and concluded that the options were not issued at a significant and incremental discount, and therefore do not provide material rights. As such, they are excluded as performance obligations at the outset of the arrangement. The Company determined that each license and the related research and development services were not distinct from one another, as the license has limited value without the performance of the research and development activities. As such, the Company determined that these promises should be combined into a single performance obligation for each molecule, resulting in a total of three performance obligations; one for flotetuzumab, one for MGD007, and one for the third DART molecule. The Company determined that the $20.0 million upfront payment from Servier constituted the entirety of the consideration to be included in the transaction price as of the outset of the arrangement, and the transaction price was allocated to the three performance obligations based on their relative standalone selling price. The milestone payments that the Company was eligible to receive prior to the exercise of the options were excluded from the transaction price, as all milestone amounts were fully constrained based on the probability of achievement. Two milestones were achieved in 2014 when the INDs for flotetuzumab and MGD007 were cleared by the Food and Drug Administration (FDA). Upon achievement of each milestone, the constraint related to the $5.0 million milestone payment was removed and the transaction price was re-assessed. This variable consideration was allocated to each specific performance obligation in accordance with ASC 606. Revenue associated with each performance obligation was recognized as the research and development services were provided using a cost-based input method according to research and development costs incurred to date compared to estimated total research and development costs. The transfer of control occurred over this time period and, in management’s judgment, was the best measure of progress towards satisfying the performance obligation. No revenue was recognized related to the MGD007 option during the year ended December 31, 2019. During the years ended December 31, 2018 and 2017, the Company recognized revenue of $1.9 million and $1.1 million, respectively, related to the MGD007 option. No revenue was deferred related to the MGD007 option at December 31, 2018. As discussed above, in 2014, Servier exercised its option to obtain a license to develop and commercialize flotetuzumab in its territories and paid the Company a $15.0 million license grant fee. Upon exercise, the Company's contractual obligations include (i) granting Servier an exclusive license to its intellectual property, (ii) technical, scientific and intellectual property support to the research plan and (iii) participation on an executive committee and a research and development committee. Under the terms of the Servier Agreement, the Company and Servier will share costs incurred to develop flotetuzumab during the license term. Due to the fact that both parties share costs and are exposed to significant risks and rewards dependent on the commercial success of the product, the Company determined that the arrangement is a collaborative arrangement within the scope of ASC 808. The arrangement consists of two components; the license of flotetuzumab and the research and development activities, including committee participation, to support the research plan. Under the provisions of ASC 808, the Company has determined that it will use ASC 606 by analogy to recognize the revenue related to the license. The Company evaluated its performance obligation to provide Servier with an exclusive license to develop and commercialize flotetuzumab and determined that its transaction price is equal to the license grant fee payment of $15.0 million and Servier consumes the benefits of the license over time as the research and development activities are performed. Therefore, the Company is recognizing the transaction price over the development period, using an input method according to research and development costs incurred to date compared to estimated total research and development costs. As noted above, in July 2019, Servier informed the Company of its intention to terminate the Servier Agreement and the agreement was terminated effective January 15, 2020. Therefore, the Company reassessed the end date of its performance obligations under the contract to be January 15, 2020. During the years ended December 31, 2019, 2018 and 2017 the Company recognized revenue of $11.6 million, $1.2 million, and $1.4 million, respectively, related to the flotetuzumab license grant fee. At December 31, 2019, $1.0 million of revenue related to the flotetuzumab license grant fee was deferred, all of which was current. The research and development activities component of the arrangement is not analogous to ASC 606, therefore the Company follows its policy to record expense incurred as research and development expense and record reimbursements received from Servier as an offset to research and development expense on the consolidated statement of operations and comprehensive loss during the development period. During the years ended December 31, 2019, 2018 and 2017, the Company recorded approximately $3.6 million, $6.0 million and $3.2 million, respectively, as an offset to research and development expense under this collaborative arrangement. Zai Lab In November 2018, the Company entered into a collaboration and license agreement with Zai Lab (Zai Lab Agreement) under which Zai Lab obtained regional development and commercialization rights in mainland China, Hong Kong, Macau and Taiwan (Zai Lab’s territory) for (i) margetuximab, an immune-optimized anti-HER2 monoclonal antibody, (ii) MGD013, a bispecific DART molecule designed to provide coordinate blockade of PD-1 and LAG-3 for the potential treatment of a range of solid tumors and hematological malignancies, and (iii) an undisclosed multi-specific TRIDENT molecule in preclinical development. Zai Lab will lead clinical development of these molecules in its territory. Under the terms of the Zai Lab Agreement, Zai Lab paid the Company an upfront payment of $25.0 million, less foreign withholding tax of $2.5 million. Assuming successful development and commercialization of margetuximab, MGD013 and the TRIDENT molecule, the Company could receive up to $140.0 million in development and regulatory milestones. In addition, Zai Lab would pay the Company tiered royalties at percentage rates of mid-teens to 20% for net sales of margetuximab in Zai Lab’s territory, mid-teens for net sales of MGD013 in Zai Lab’s territory and 10% for net sales of the TRIDENT molecule in Zai Lab’s territory, which may be subject to adjustment in specified circumstances. The Company evaluated the Zai Lab Agreement under the provisions of ASC 606 and identified the following material promises under the arrangement for each of the two product candidates, margetuximab and MGD013: (i) an exclusive license to develop and commercialize the product candidate in Zai Lab’s territory and (ii) certain research and development activities. The Company determined that each license and the related research and development activities were not distinct from one another, as the license has limited value without the performance of the research and development activities. As such, the Company determined that these promises should be combined into a single performance obligation for each product candidate. Activities related to margetuximab and MGD013 are separate performance obligations from each other because they are capable of being distinct, and are distinct in the context of the contract. The Company evaluated the promises related to the TRIDENT molecule and determined they were immaterial in context of the contract, therefore there is no performance obligation related to that molecule. The Company determined that the $25.0 million (less foreign withholding tax of $2.5 million) upfront payment from Zai Lab constituted the entirety of the consideration to be included in the transaction price as of the outset of the arrangement, and the transaction price was allocated to the two performance obligations based on their relative standalone selling price. The standalone selling price of the performance obligations was determined using the adjusted market assessment approach considering similar collaboration and license agreements. The potential development and regulatory milestone payments are fully constrained until the Company concludes that achievement of the milestone is probable, and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods, and as such have been excluded from the transaction price. Any consideration related to royalties will be recognized if and when the related sales occur, as they were determined to relate predominantly to the license granted to Zai Lab and, therefore, have also been excluded from the transaction price. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. Due to the relatively short-term nature of the recognition period, the revenue associated with the MGD013 performance obligation is being recognized on a straight-line basis as the Company performs research and development activities under the agreement. The fixed consideration related to the margetuximab performance obligation is also being recognized on a straight-line basis as the Company performs research and development activities under the agreement. Straight-line recognition is materially consistent with the pattern of performance of the research and development activities of each product candidate. The variable consideration related to the margetuximab performance obligation will be recognized upon certain regulatory achievements. During the years ended December 31, 2019 and 2018, the Company recognized revenue of $16.1 million and $1.3 million, respectively, related to the Zai Lab Agreement. At December 31, 2019, $5.0 million of revenue was deferred under this agreement, all of which was current. In February 2020, Zai Lab announced that the first patients were dosed in two separate clinical studies; one utilizing MGD013 and one utilizing margetuximab. The Company is entitled to a total of $4.0 million as a result of these milestones (less foreign withholding tax). During the year ended December 31, 2019, the Company entered into two agreements under which the Company is to perform manufacturing services for Zai Lab’s clinical needs of margetuximab and MGD013 (Zai Lab Clinical Supply Agreements). The Company evaluated the agreements under ASC 606 and determined that they should be accounted for as a single contract and identified two performance obligations within that contract: to perform services related to manufacturing the clinical supply of margetuximab and MGD013. The transaction price is based on the costs incurred to manufacture drug product and drug substance, and is recognized over time as the services are provided, as the performance by the Company does not create an asset with an alternative use and the Company has an enforceable right to payment for the performance completed to date. During the year ended December 31, 2019, the Company recognized revenue of $2.2 million related to the Zai Lab Clinical Supply Agreements. I-Mab Biopharma In July 2019, the Company entered into a collaboration and license agreement with I-Mab Biopharma (I-Mab) to develop and commercialize enoblituzumab, an immune-optimized, anti-B7-H3 monoclonal antibody that incorporates the Company's proprietary Fc Optimization technology platform (I-Mab Agreement). I-Mab obtained regional development and commercialization rights in mainland China, Hong Kong, Macau and Taiwan (I-Mab's territory), will lead clinical development of enoblituzumab in its territories, and will participate in global studies conducted by the Company. Under the terms of the I-Mab Agreement, I-Mab paid the Company an upfront payment of $15.0 million. Assuming successful development and commercialization of enoblituzumab, the Company could receive up to $135.0 million in development and regulatory milestones. In addition, I-Mab would pay the Company tiered royalties ranging from mid teens to twenty percent on annual net sales in I-Mab's territory. The Company evaluated the I-Mab Agreement under the provisions of ASC 606 and identified the following material promises under the arrangement: (i) an exclusive license to develop and commercialize enoblituzumab in I-Mab’s territories, (ii) perform certain research and development activities and (iii) conduct a chronic toxicology study. The Company determined that the license and the related research and development activities were not distinct from one another, as the license has limited value without the performance of the research and development activities. As such, the Company determined that the license and related research and development activities should be combined into a single performance obligation. The Company determined that the $15.0 million upfront payment from I-Mab constituted the entirety of the consideration to be included in the transaction price as of the outset of the arrangement for the license and related research and development activities. The Company has also determined that the chronic toxicology study is distinct from the other promises and has estimated the variable consideration of that performance obligation to be approximately $1.0 million. I-Mab will pay the Company for the cost of this study as the costs are incurred and I-Mab will be entitled to a one-time credit of eighty percent of the total amount of such costs against a future milestone, at which point the Company will reassess the transaction price for that milestone. The potential development and regulatory milestone payments are fully constrained until the Company concludes that achievement of the milestone is probable, and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods, and as such have been excluded from the transaction price. Any consideration related to royalties will be recognized if and when the related sales occur, as they were determined to relate predominantly to the license granted to I-Mab and, therefore, have also been excluded from the transaction price. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. Revenue under the I-Mab Agreement is being recognized using a cost-based input method according to costs incurred to date compared to estimated total costs. The transfer of control occurs over this time period and, in management’s judgment, is the best measure of progress towards satisfying the performance obligations. During the year ended December 31, 2019, the Company recognized revenue of $2.3 million related to the I-Mab Agreement. At December 31, 2019, $13.5 million in revenue was deferred under the I-Mab Agreement, $4.4 million of which was current and $9.1 million of which was non-current. Roche In December 2017, the Company entered into a research collaboration and license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche) to jointly discover and develop novel bispecific molecules to undisclosed targets (Roche Agreement). During the research term, both companies would leverage their respective platforms, including the Company's DART platform and Roche's CrossMAb and DutaFab technologies to select a bispecific format and lead product candidate. Roche would then further develop and commercialize any such product candidate. Each company would be responsible for their own expenses during the research period. In August 2019, Roche informed the Company of its intention to terminate the Roche Agreement, and the agreement was terminated effective November 21, 2019. Under the terms of the Roche Agreement, Roche received rights to use certain of the Company’s intellectual property rights to exploit collaboration compounds and products, and paid the Company an upfront payment of $10.0 million which was received in January 2018. The Company will also be eligible to receive up to $370.0 million in potential milestone payments and royalties on future sales. As of December 31, 2019, the Company has not recognized any milestone revenue under this agreement. The Company evaluated the Roche Agreement under the provisions of ASC 606 and identified the following promises under the agreement: (i) the non-exclusive, non-transferable, non-sublicensable license to the Company's intellectual property and (ii) the performance of certain activities during the research period. The Company determined that the license was capable of being distinct, but was not distinct in the context of the contract because it had limited value to Roche without the research activities required to be performed by the Company. Therefore, the Company concluded that there was one performance obligation under the agreement. The Company determined that the transaction price of the Roche Agreement was $10.0 million. The potential milestone payments were fully constrained and were excluded from the transaction price. Any consideration related to sales-based royalties would be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Roche and therefore were also excluded from the transaction price. The $10.0 million transaction price was being recognized over the expected research period, which was originally 30 months, using a cost-based input method to measure performance. Upon notice of Roche's intent to terminate the agreement in August 2019, the recognition period was adjusted to end in November 2019. The Company recognized revenue under this agreement of $6.0 million and $4.0 million, respectively, during the years ended December 31, 2019 and 2018. There was no revenue deferred under this agreement at December 31, 2019. At December 31, 2018, $6.0 million was deferred under this agreement, $4.0 million of which was current and $2.0 million of which was non-current. Provention Bio, Inc. In May 2018, the Company entered into a license agreement with Provention Bio, Inc. (Provention) pursuant to which the Company granted Provention exclusive global rights for the purpose of developing and commercializing MGD010 (renamed PRV-3279), a CD32B x CD79B DART molecule being developed for the treatment of autoimmune indications (Provention License Agreement). As partial consideration for the Provention License Agreement, Provention granted the Company a warrant to purchase shares of Provention’s common stock at an exercise price of $2.50 per share. If Provention successfully develops, obtains regulatory approval for, and commercializes PRV-3279, the Company will be eligible to receive up to $65.0 million in development and regulatory milestones and up to $225.0 million in commercial milestones. As of December 31, 2019, the Company has not recognized any milestone revenue under this agreement. If commercialized, the Company would be eligible to receive single-digit royalties on net sales of the product. The license agreement may be terminated by either party upon a material breach or bankruptcy of the other party, by Provention without cause upon prior notice to the Company, and by the Company in the event that Provention challenges the validity of any licensed patent under the agreement, but only with respect to the challenged patent. Also in May 2018, the Company entered into an asset purchase agreement with Provention pursuant to which Provention acquired the Company’s interest in teplizumab (renamed PRV-031), a monoclonal antibody being developed for the treatment of type 1 diabetes (Asset Purchase Agreement). As partial consideration for the Asset Purchase Agreement, Provention granted the Company a warrant to purchase shares of Provention’s common stock at an exercise price of $2.50 per share. If Provention successfully develops, obtains regulatory approval for, and commercializes PRV-031, the Company will be eligible to receive up to $170.0 million in regulatory milestones and up to $225.0 million in commercial milestones. As of December 31, 2019, the Company has not recognized any milestone revenue under this agreement. If commercialized, the Company would be eligible to receive single-digit royalties on net sales of the product. Provention has also agreed to pay third-party obligations, including low single-digit royalties, a portion of which is creditable against royalties payable to the Company, aggregate milestone payments of up to approximately $1.3 million and other consideration, for certain third-party intellectual property under agreements Provention is assuming pursuant to the Asset Purchase Agreement. Further, Provention is required to pay the Company a low double-digit percentage of certain consideration to the extent it is received in connection with a future grant of rights to PRV-031 by Provention to a third party. The Company evaluated the Provention License Agreement and Asset Purchase Agreement under the provisions of ASC 606 and determined that they should be accounted for as a single contract and identified two performance obligations within that contract: (i) the license of MGD010 and (ii) the title to teplizumab. The Company determined that the transaction price of the Provention agreements was $6.1 million, based on the Black-Scholes valuation of the warrants to purchase a total of 2,432,688 shares of Provention's common stock. The transaction price was allocated to each performance obligation based on the number of shares of common stock the Company is entitled to purchase under each warrant. The potential development and regulatory milestone payments are fully constrained until the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods, and as such have been excluded from the transaction price. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur, therefore they have also been excluded from the transaction price. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. The Company recognized revenue of $6.1 million when it satisfied its performance obligations and transferred the MGD010 license and teplizumab assets to Provention in 2018. The warrants were revalued at each reporting period based on current Black-Scholes parameters until the warrants were exercised in July 2019. The resulting increase or decrease is reflected in Other income (expense) on the consolidated statement of operations and comprehensive loss. The warrants were valued at $1.9 million as of December 31, 2018, and were reported in Other assets on the consolidated balance sheet. During 2019, through the date that they were exercised, the Company recorded an increase in the valuation of the warrants of approximately $20.1 million. In July 2019, the Company exercised the warrants on a cashless basis, and subsequently sold all the shares of Provention common stock acquired through the exercise. No shares of Provention stock were held at December 31, 2019. NIAID Contract The Company entered into a contract with the National Institute of Allergy and Infectious Diseases (NIAID), effective as of September 15, 2015, to perform product development and to advance up to two DART molecules, including MGD014. Under this contract, the Company will develop these product candidates for Phase 1/2 clinical trials as therapeutic agents, in combination with latency reversing treatments, to deplete cells infected with human immunodeficiency virus (HIV) infection. NIAID does not receive goods or services from the Company under this contract, therefore the Company does not consider NIAID to be a customer and concluded this contract is outside the scope of ASC 606. This contract includes a base p |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies On September 13, 2019, a securities class action complaint was filed in the U.S. District Court for the District of Maryland by Todd Hill naming the Company, its Chief Executive Officer, Dr. Koenig, and its Chief Financial Officer, Mr. Karrels, as defendants for allegedly making false and materially misleading statements regarding the Company’s SOPHIA trial. The complaint asserts a putative class period stemming from February 6, 2019 to June 3, 2019. On November 12, 2019, the Employees’ Retirement System of the City of Baton Rouge and Parish of East Baton Rouge sought appointment as lead plaintiff, which motion remains pending. The Company intends to vigorously defend against this action. However, the outcome of this legal proceeding is uncertain at this time and the Company cannot reasonably estimate a range of loss, if any. Accordingly, the Company has not accrued any liability associated with this action. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2019 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | Employee Benefit Plan In 2002, the Company established the MacroGenics 401(k) Plan (the Plan) for its employees under Section 401(k) of the IRC. Under this Plan, all employees at least 21 years of age are eligible to participate in the Plan, starting on the first day of each month. Employees may contribute up to 100% of their salary, subject to government maximums. Employees are 100% vested in their contributions to the Plan. The Company's contribution to the Plan, as determined by the Board of Directors, is discretionary. The Company's contributions to the Plan totaled $1.4 million, $1.3 million and $1.1 million for the years ended December 31, 2019, 2018 and 2017, respectively. |
Quarterly Financial Information
Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information (Unaudited) | Quarterly Financial Information (unaudited) 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter (in thousands, except per share data) 2019 Revenue $ 9,662 $ 10,593 $ 18,741 $ 25,192 Net loss (45,017) (31,767) (44,631) (30,396) Net loss per share, basic and diluted $ (0.99) $ (0.65) $ (0.91) $ (0.62) 2018 Revenue $ 4,695 $ 18,834 $ 20,798 $ 15,794 Net loss (49,536) (43,244) (34,029) (44,644) Net loss per share, basic and diluted $ (1.34) $ (1.03) $ (0.81) $ (1.06) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, MacroGenics UK Limited and MacroGenics Limited. All intercompany accounts and transactions have been eliminated in consolidation. The Company currently operates in one operating segment. Operating segments are defined as components of an enterprise about which separate discrete information is available for the chief operating decision maker, or decision making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business in one segment, which is developing monoclonal antibody-based therapeutics for cancer, autoimmune and infectious diseases. |
Use of Estimates | Use of Estimates The preparation of the financial statements in accordance with generally accepted accounting principles (GAAP) requires the Company to make estimates and judgments in certain circumstances that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. In preparing these consolidated financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements, giving due consideration to materiality. On an ongoing basis, the Company evaluates its estimates, including those related to revenue recognition, fair values of assets, stock-based compensation, income taxes, preclinical study and clinical trial accruals and other contingencies. Management bases its estimates on historical experience or on various other assumptions that it believes to be reasonable under the circumstances. Actual results could differ from these estimates. |
Cash, Cash Equivalents and Marketable Securities | Cash, Cash Equivalents and Marketable Securities The Company considers all investments in highly liquid financial instruments with a maturity of 90 days or less at the date of purchase to be cash equivalents. Cash and cash equivalents includes investments in money market funds with commercial banks and financial institutions, securities issued by the U.S. government and its agencies, Government Sponsored Enterprise agency debt obligations and corporate debt obligations. Cash equivalents are stated at amortized cost, plus accrued interest, which approximates fair value. The Company carries marketable securities classified as available-for-sale at fair value as determined by prices for identical or similar securities at the balance sheet date. Marketable securities consist of Level 2 financial instruments in the fair-value hierarchy. The Company records unrealized gains and losses as a component of other comprehensive loss within the statements of operations and comprehensive loss and as a separate component of stockholders' equity. Realized gains or losses on available-for-sale securities are determined using the specific identification method and the Company includes net realized gains and losses in other income (expense). At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the unrealized loss is other-than-temporary. The Company considers factors including: the significance of the decline in value compared to the cost basis, underlying factors contributing to a decline in the prices of securities in a single asset class, the length of time the market value of the security has been less than its cost basis, the security's relative performance versus its peers, sector or asset class, expected market volatility and the market and economy in general. The Company also evaluates whether it is more likely than not that it will be required to sell a security prior to recovery of its fair value. An impairment loss is recognized at the time the Company determines that a decline in the fair value below its cost basis is other-than-temporary. There were no unrealized losses at December 31, 2019 or 2018 that the Company determined to be other-than-temporary. |
Accounts Receivable | Accounts Receivable Accounts receivable that management has the intent and ability to collect are reported in the consolidated balance sheets at outstanding amounts, less an allowance for doubtful accounts. The Company writes off uncollectible receivables when the likelihood of collection is remote. The Company evaluates the collectability of accounts receivable on a regular basis. The allowance, if any, is based upon various factors including the financial condition and payment history of customers, an overall review of collections experience on other accounts and economic factors or events expected to affect future collections experience. No allowance was recorded as of December 31, 2019 or 2018, as the Company has a history of collecting on all outstanding accounts. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company's financial instruments consist of cash and cash equivalents, marketable securities, accounts receivable, accounts payable and accrued expenses. The carrying amount of accounts receivable, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of their short-term nature. The Company accounts for recurring and non-recurring fair value measurements in accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 820, Fair Value Measurements and Disclosures (ASC 820). ASC 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value, and requires expanded disclosures about fair value measurements. The ASC 820 hierarchy ranks the quality of reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories: • Level 1 – Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. • Level 2 – Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. • Level 3 – Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity – e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC 820 hierarchy. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, marketable securities and accounts receivable. The Company maintains its cash and money market funds with financial institutions that are federally insured. While balances deposited in these institutions often exceed Federal Deposit Insurance Corporation limits, the Company has not experienced any losses on related accounts to date. The Company's investment policy limits investments to certain types of debt securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The counterparties are various corporations, financial institutions and government agencies of high credit standing. |
Property, Equipment and Software | Property, Equipment and SoftwareProperty, equipment and software are stated at cost. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation or amortization are removed from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company assesses the recoverability of its long-lived assets in accordance with the provisions of ASC 360, Property, Plant and Equipment (ASC 360). ASC 360 requires that long-lived assets be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset or asset group. If carrying value exceeds the sum of undiscounted cash flows, the Company then determines the fair value of the underlying asset group. Any impairment to be recognized is measured by the amount by which the carrying amount of the asset group exceeds the estimated fair value of the asset group. Assets to be disposed of are reported at the lower of the carrying amount or fair value, less costs to sell. For the years ended December 31, 2019, 2018 and 2017, the Company determined that there were no impaired assets. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income in the period that such tax rate changes are enacted. The measurement of a deferred tax asset is reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured as the largest amount that is more likely than not to be realized upon ultimate settlement. The Company's policy is to record interest and penalties related to uncertain tax positions as a component of income tax expense. |
Revenues | Revenues Beginning on January 1, 2018, the Company recognizes revenue under Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customer s and all related amendments (collectively ASC 606) 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. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company enters into licensing agreements that are within the scope of ASC 606, under which it may license rights to research, develop, manufacture and commercialize its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; reimbursement of certain costs; customer option exercise fees; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products. The Company may also enter into development and manufacturing service agreements with its collaborators. For each arrangement that results in revenues, the Company identifies all performance obligations, which may include a license to intellectual property and know-how, research and development activities, transition activities and/or manufacturing services. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required. Once the estimated transaction price is established, amounts are allocated to the performance obligations that have been identified. The transaction price is generally allocated to each separate performance obligation on a relative standalone selling price basis. The Company must develop assumptions that require judgment to determine the standalone selling price in order to account for these agreements. To determine the standalone selling price, the Company’s assumptions may include (i) the probability of obtaining marketing approval for the product candidate, (ii) estimates regarding the timing and the expected costs to develop and commercialize the product candidate, and (iii) estimates of future cash flows from potential product sales with respect to the product candidate. Standalone selling prices used to perform the initial allocation are not updated after contract inception. The Company does not include a financing component to its estimated transaction price at contract inception unless it estimates that certain performance obligations will not be satisfied within one year. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Licenses. If the license to the Company’s intellectual property is determined to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and when (or as) the customer is able to use and benefit from the license. In assessing whether a promise or performance obligation is distinct from the other promises, the Company considers factors such as the research, development, manufacturing and commercialization capabilities of the licensee and the availability of the associated expertise in the general marketplace. In addition, the Company considers whether the licensee can benefit from a promise for its intended purpose without the receipt of the remaining promise, whether the value of the promise is dependent on the unsatisfied promise, whether there are other vendors that could provide the remaining promise, and whether it is separately identifiable from the remaining promise. For licenses that are combined with other promises, the Company utilizes 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. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The measure of progress, and thereby periods over which revenue should be recognized, are subject to estimates by management and may change over the course of the research and development and licensing agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Research, Development and/or Manufacturing Services. The promises under the Company’s agreements may include research and development or manufacturing services to be performed by the Company on behalf of the counterparty. If these services are determined to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to these services as revenue over time based on an appropriate measure of progress when the performance by the Company does not create an asset with an alternative use and the Company has an enforceable right to payment for the performance completed to date. If these services are determined not to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the combined performance obligation as the related performance obligations are satisfied. Customer Options. If an arrangement contains customer options, the Company evaluates whether the options are material rights because they allow the customer to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. The Company allocates the transaction price to material rights based on the relative standalone selling price, which is determined based on the identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised. If the options are deemed not to be a material right, they are excluded as performance obligations at the outset of the arrangement. Milestone Payments. At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Royalties. For arrangements that include sales-based royalties which are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. The Company analyzes its collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties who are both active participants in the activities and are both exposed to significant risks and rewards dependent on the commercial success of such activities. Such arrangements generally are within the scope of ASC 808, Collaborative Arrangements (ASC 808). While ASC 808 defines collaborative arrangements and provides guidance on income statement presentation, classification, and disclosures related to such arrangements, it does not address recognition and measurement matters, such as (1) determining the appropriate unit of accounting or (2) when the recognition criteria are met. Therefore, the accounting for these arrangements is either based on an analogy to other accounting literature or an accounting policy election by the Company. The Company accounts for certain components of the collaboration agreement that are reflective of a vendor-customer relationship (e.g., licensing arrangement) based on an analogy to ASC 606. The Company accounts for other components based on a reasonable, rational and consistently applied accounting policy election. Reimbursements from the counter-party that are the result of a collaborative relationship with the counter-party, instead of a customer relationship, such as co-development activities, are recorded as a reduction to research and development expense as the services are performed. For a complete discussion of accounting for revenue from collaborative and other agreements, see Note 9, Collaboration and Other Agreements. |
Research and Development Costs, Including Clinical Trial Accruals/Expenses | Research and Development Costs, Including Clinical Trial Accruals/Expenses Research and development expenditures are expensed as incurred. Research and development costs primarily consist of employee related expenses, including salaries and benefits, expenses incurred under agreements with contract research organizations (CROs), investigative sites and consultants that conduct the Company's clinical trials, the cost of acquiring and manufacturing clinical trial materials, including costs incurred under agreements with contract manufacturing organizations (CMOs), and other allocated expenses, license fees for and milestone payments related to in-licensed products and technologies, stock-based compensation expense, and costs associated with non-clinical activities and regulatory approvals. Right-to-develop agreements may contain cost-sharing provisions whereby the Company and the collaborator share the cost of research and development activities. Reimbursement of research and development expenses received in connection with these agreements is recorded as a reduction of such expenses. Clinical trial expenses are a significant component of research and development expenses, and the Company outsources a significant portion of these costs to third parties. Third party clinical trial expenses include investigator fees, site and patient costs, clinical research organization (CRO) costs, costs for central laboratory testing, data management and CMO costs. The accrual for site and patient costs includes inputs such as estimates of patient enrollment, patient cycles incurred, clinical site activations, and other pass-through costs. These inputs are required to be estimated due to a lag in receiving the actual clinical information from third parties. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as a prepaid asset or accrued expenses. These third party agreements are generally cancellable, and related costs are recorded as research and development expenses as incurred . Non-refundable advance clinical payments for goods or services that will be used or rendered for future research and development activities are recorded as a prepaid asset and recognized as expense as the related goods are delivered or the related services are performed. When evaluating the adequacy of the accrued expenses, management analyzes progress of the studies, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be made in determining the accrued balances at the end of any reporting period. |
Stock-based Compensation | Stock-based Compensation Stock-based payments are accounted for in accordance with the provisions of ASC 718, Compensation – Stock Compensation . The fair value of stock-based payments is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. For awards that contain a performance condition, expense is amortized using the accelerated attribution method. Recognition of stock-based compensation expense is based on the value of the portion of stock-based awards that is ultimately expected to vest during the period. The Company utilizes the Black-Scholes model for estimating fair value of its stock options granted. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss represents net loss adjusted for the change during the periods attributed to unrealized gains and losses on available-for-sale debt securities. |
Net Loss Per Share | Net Loss Per ShareBasic and diluted loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. All stock options and restricted stock units (RSUs) are excluded from the per share calculations as such securities were anti-dilutive for all periods presented. |
Recently Adopted and Issued Accounting Standards | Recently Adopted Accounting Standards In May 2014, the FASB issued ASC 606. The Company adopted ASC 606 on January 1, 2018 using the modified retrospective method for all contracts that were not completed as of January 1, 2018. For contracts that were modified before the effective date, the Company reflected the aggregate effect of all modifications when identifying performance obligations and allocating transaction price in accordance with available practical expedients. Comparative prior period information continues to be reported under the accounting standards in effect for the period presented. As a result of applying the modified retrospective method to adopt the new guidance, the following adjustments were made to accounts on the consolidated balance sheet as of January 1, 2018 (in thousands): Pre-Adoption ASC 606 Adjustment Post-Adoption Deferred revenue, current $ 7,202 $ 540 $ 7,742 Deferred revenue, net of current portion 13,637 5,939 19,576 Accumulated deficit (312,340) (6,478) (318,818) The transition adjustment resulted primarily from changes in the pattern of revenue recognition for upfront fees and license grant fees. The following table shows the impact of adoption to the consolidated statement of income and balance sheet (in thousands): Year Ended December 31, 2018 As Reported Balances Without Adoption of ASC 606 Effect of Change Higher/(Lower) Revenue from collaborative agreements $ 58,644 $ 58,104 $ 540 Net loss (171,453) (171,993) (540) Basic and diluted net loss per common share $ (4.19) $ (4.20) $ 0.01 As of December 31, 2018 As Reported Balances Without Adoption of ASC 606 Effect of Change Higher/(Lower) Deferred revenue, current $ 21,721 $ 22,210 $ (489) Deferred revenue, net of current portion 19,001 12,573 6,428 Accumulated deficit (490,271) $ (484,332) $ (5,939) The following table presents changes in the Company’s contract liabilities during the year ended December 31, 2018 (in thousands): Balance at Beginning of Period Additions Deductions Balance at End of Period Deferred revenue (current and non-current) $ 27,318 $ 22,992 $ (9,588) $ 40,722 During the year ended December 31, 2018, the Company recognized $9.6 million in revenue as a result of changes in the contract liability balance. In February 2016, the FASB issued ASU 2016-02, which requires lessees to recognize a right-of-use (ROU) asset and a lease liability for all leases with terms greater than 12 months and also requires disclosures by lessees and lessors about the amount, timing and uncertainty of cash flows arising from leases. Subsequent to the issuance of ASU 2016-02, the FASB clarified the guidance through several ASUs, with the resulting guidance collectively referred to as ASC 842. The Company adopted ASC 842 effective January 1, 2019, using the optional transition method provided under ASU 2018-11, which did not require adjustments to comparative periods nor require modified disclosures in those comparative periods. The Company has elected not to recognize leases with terms of one year or less on the balance sheet. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances. For leases where the Company is the lessee, ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term of the lease for which the rate is estimated. Certain adjustments to the ROU asset may be required for items such as initial direct costs paid or incentives received. The lease terms used to calculate the ROU asset and related lease liabilities include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while the expense for finance leases is recognized as depreciation expense and interest expense using the accelerated interest method of recognition. The Company has lease agreements which require payments for lease and non-lease components and has elected the practical expedient not to separate non-lease components from lease components for all classes of underlying assets. As a result of the cumulative impact of adopting ASC 842, the Company recorded operating lease ROU assets of $16.4 million and operating lease liabilities of $27.7 million as of January 1, 2019, primarily related to real estate leases, based on the present value of the future lease payments on the date of adoption. The ROU asset is included in Other assets on the consolidated balance sheets. Refer to Note 5, Leases, for additional disclosures required by ASC 842. Recently Issued Accounting Standards In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326) (ASU 2016-13), which modifies the measurement of expected credit losses on certain financial instruments. In addition, for available-for-sale debt securities, the standard eliminates the concept of other-than-temporary impairment and requires the recognition of an allowance for credit losses rather than reductions in the amortized cost of the securities. The standard is effective for interim and annual periods beginning after December 15, 2019 and requires a modified-retrospective approach with a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period. Based on the composition of the Company's investment portfolio, current market conditions and historical credit loss activity, the adoption of ASU 2016-13 is not expected to have a material impact on its consolidated financial position, results of operations or the related disclosures. In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (ASU 2018-15). This new standard requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in ASC 350-40, Accounting for Internal-Use Software , to determine which implementation costs to capitalize as assets and amortize over the term of the hosting arrangement or expense as incurred. This standard is effective for interim and annual periods beginning after December 15, 2019. Entities have the option to apply this standard prospectively to all implementation costs incurred after the date of adoption or retrospectively. The Company is evaluating this new standard, but does not expect it to have a significant impact on its financial statement presentation or results. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808)—Clarifying the interaction between Topic 808 and Topic 606 (ASU 2018-18). The amendments provide guidance on whether certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606. It also specifically (i) addresses when the participant should be considered a customer in the context of a unit of account, (ii) adds unit-of-account guidance in ASC 808 to align with guidance in ASC 606, and (iii) precludes presenting revenue from a collaborative arrangement together with revenue recognized under ASC 606 if the collaborative arrangement participant is not a customer. The guidance will be effective for fiscal years beginning after December 15, 2019. Early adoption is permitted and should be applied retrospectively. The Company does not anticipate the adoption of this standard will have a material impact on its consolidated financial statements. The Company has evaluated all other ASUs issued through the date the consolidated financials were issued and believes that the adoption of these will not have a material impact on the Company's consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Fair Value Measurement Financial Assets | Financial assets measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurement at December 31, 2019 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total Level 1 Level 2 Level 3 Assets: Money market funds $ 46,149 $ 46,149 $ — $ — Government-sponsored enterprises 13,222 — 13,222 — Corporate debt securities 103,135 — 103,135 — Total assets measured at fair value (a) $ 162,506 $ 46,149 $ 116,357 $ — Fair Value Measurement at December 31, 2018 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total Level 1 Level 2 Level 3 Assets: Money market funds $ 46,257 $ 46,257 $ — $ — U.S Treasury securities 12,488 — 12,488 — Corporate debt securities 100,214 — 100,214 — Common stock warrants 1,890 — — $ 1,890 Total assets measured at fair value (b) $ 160,849 $ 46,257 $ 112,702 $ 1,890 (a) Total assets measured at fair value at December 31, 2019 includes approximately $73.2 million reported in cash and cash equivalents on the balance sheet. (b) Total assets measured at fair value at December 31, 2018 includes approximately $146.2 million reported in cash and cash equivalents on the balance sheet. |
Summary of Percentage of Customer Concentration | The following table includes those collaborators that represent more than 10% of total revenue earned in the periods indicated: Year Ended December 31, 2019 2018 2017 Incyte Corporation (Incyte) 35% 68% 96% Zai Lab Limited (Zai Lab) 29% * * Les Laboratoires Servier and Institut de Recherches Servier (Servier) 18% * * * Balance is less than 10% The following table includes those counterparties that represent more than 10% of accounts receivable at the date indicated: December 31, 2019 2018 Incyte 62% 16% Zai Lab 23% 76% |
Estimated Useful Lives | Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Computer equipment 3 years Software 3 years Furniture 10 years Laboratory and office equipment 5 years Leasehold improvements Shorter of lease term or useful life |
Schedule of Stock Options and RSUs Excluded from the Calculation of Net Loss Per Share | The following table presents the number of stock options and RSUs that were excluded from the calculation of net loss per share: Year Ended December 31, 2019 2018 2017 Stock options and RSUs 7,159,494 5,273,964 4,504,642 |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | As a result of applying the modified retrospective method to adopt the new guidance, the following adjustments were made to accounts on the consolidated balance sheet as of January 1, 2018 (in thousands): Pre-Adoption ASC 606 Adjustment Post-Adoption Deferred revenue, current $ 7,202 $ 540 $ 7,742 Deferred revenue, net of current portion 13,637 5,939 19,576 Accumulated deficit (312,340) (6,478) (318,818) The transition adjustment resulted primarily from changes in the pattern of revenue recognition for upfront fees and license grant fees. The following table shows the impact of adoption to the consolidated statement of income and balance sheet (in thousands): Year Ended December 31, 2018 As Reported Balances Without Adoption of ASC 606 Effect of Change Higher/(Lower) Revenue from collaborative agreements $ 58,644 $ 58,104 $ 540 Net loss (171,453) (171,993) (540) Basic and diluted net loss per common share $ (4.19) $ (4.20) $ 0.01 As of December 31, 2018 As Reported Balances Without Adoption of ASC 606 Effect of Change Higher/(Lower) Deferred revenue, current $ 21,721 $ 22,210 $ (489) Deferred revenue, net of current portion 19,001 12,573 6,428 Accumulated deficit (490,271) $ (484,332) $ (5,939) |
Rollforward of Contract Liabilities | The following table presents changes in the Company’s contract liabilities during the year ended December 31, 2018 (in thousands): Balance at Beginning of Period Additions Deductions Balance at End of Period Deferred revenue (current and non-current) $ 27,318 $ 22,992 $ (9,588) $ 40,722 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-For-Sale Securities | Available-for-sale marketable securities as of December 31, 2019 and 2018 were as follows (in thousands): December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Government-sponsored enterprises $ 13,216 $ 6 $ — $ 13,222 Corporate debt securities 76,052 20 (10) 76,062 Total $ 89,268 $ 26 $ (10) $ 89,284 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate debt securities $ 12,738 $ — $ (3) $ 12,735 All of the Company's available-for-sale securities held at December 31, 2019 and 2018 had maturity dates of less than one year. |
Property, Equipment and Softw_2
Property, Equipment and Software (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property, equipment and software consists of the following (in thousands): December 31, 2019 2018 Computer equipment $ 2,430 $ 2,360 Software 7,513 7,011 Furniture and office equipment 713 668 Motor Vehicles 50 — Lab equipment 38,368 36,062 Leasehold improvements 48,675 48,328 Construction in progress 187 218 Property, equipment and software 97,936 94,647 Less accumulated depreciation and amortization (49,725) (37,935) Property, equipment and software, net $ 48,211 $ 56,712 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Lease, Cost | The components of lease cost for the year ended December 31, 2019 were as follows (in thousands): Operating lease cost $ 5,463 Variable lease cost 1,366 Sublease income (942) Net lease cost $ 5,887 |
Lessee, Operating Lease, Liability, Maturity | As of December 31, 2019 , the maturities of our operating lease liabilities were as follows (in thousands): 2020 5,913 2021 6,507 2022 6,688 2023 6,536 2024 5,588 Thereafter 11,068 Total lease payments 42,300 Present value adjustment (11,727) Lease liabilities $ 30,573 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense | The following stock-based compensation amounts were recognized for the periods indicated (in thousands): Year Ended December 31, 2019 2018 2017 Research and development $ 10,023 $ 7,919 $ 7,388 General and administrative 9,548 8,601 7,356 Total stock-based compensation expense $ 19,571 $ 16,520 $ 14,744 |
Schedule of Employee Stock Options Award Valuation Assumptions | The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions in the following table: Year Ended December 31, 2019 2018 2017 Expected dividend yield 0% 0% 0% Expected volatility 74% - 76% 68% - 72% 67% - 68% Risk-free interest rate 1.4% - 2.6% 2.4% - 3.1% 1.9% - 2.3% Expected term 6.25 years 6.25 years 6.25 years |
Schedule of Stock Option Activity | The following table summarizes stock option activity for 2019: Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in thousands) Outstanding, December 31, 2018 5,273,964 $ 22.23 6.8 Granted 1,946,770 20.81 Exercised (219,045) 3.03 Forfeited or expired (294,695) 24.72 Outstanding, December 31, 2019 6,706,994 22.33 6.9 $ 4,749 December 31, 2019: Exercisable 4,298,178 22.21 5.9 4,712 Vested and expected to vest 6,446,218 22.31 6.9 4,746 |
Schedule of RSU Activity | The following table summarizes RSU activity for 2019: Shares Weighted-Average Grant Date Fair Value Outstanding, December 31, 2018 — — Granted 467,600 $ 15.32 Exercised — — Forfeited or expired (15,100) 15.32 Outstanding, December 31, 2019 452,500 15.32 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Components of the Company's Deferred Income Tax Assets (Liabilities) | The significant components of the Company's deferred income tax assets (liabilities) were as follows (in thousands): December 31, 2019 2018 Deferred income tax assets: Federal U.S. net operating loss carryforward $ 116,436 $ 87,284 State net operating loss carryforward 31,110 22,809 Research and development credit, net 35,580 29,750 Orphan drug credit, net 22,881 22,580 Operating lease liabilities 8,413 — Deferred revenue 367 3,736 Other 9,123 9,972 Gross deferred income tax assets 223,910 176,131 Valuation allowance (214,893) (172,457) Net deferred income tax assets 9,017 3,674 Deferred income tax liabilities: Depreciation (438) (1,911) Operating lease ROU assets (5,547) — Prepaid expenditures (3,032) (1,763) Gross deferred income tax liabilities (9,017) (3,674) Net deferred income tax asset/(liability) $ — $ — |
Reconciliation of Reported Estimated Income Tax Benefit | The reconciliation of the reported estimated income tax benefit to the amount that would result by applying the U.S. federal statutory tax rate to the net income is as follows (in thousands): Year Ended December 31, 2019 2018 2017 United States federal tax at statutory rate $ (31,880) $ (36,005) $ (6,869) State taxes (net of federal benefit) (9,524) (11,133) (735) Deferred income tax adjustments 2,004 (4,435) 607 Deferred state blended rate adjustments — — (485) Deferred federal rate change reduction in corporate rate — — 39,447 Research credit, net (5,830) (8,466) (8,455) Orphan drug credit, net (301) (872) (1,853) Other permanent items 1,206 148 276 Equity-based compensation 1,889 758 2,067 Change in valuation allowance 42,436 60,005 (24,000) Income tax expense/(benefit) $ — $ — $ — |
Reconciliation of the Beginning and Ending Amount of Gross Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2019 2018 2017 Beginning balance $ 4,318 $ 3,395 $ 2,465 Increases for current year tax positions 637 642 569 Increases/(decreases) for prior year tax positions (5) 281 361 Ending balance $ 4,950 $ 4,318 $ 3,395 |
Quarterly Financial Informati_2
Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Company's Consolidated Quarterly Results of Operations | 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter (in thousands, except per share data) 2019 Revenue $ 9,662 $ 10,593 $ 18,741 $ 25,192 Net loss (45,017) (31,767) (44,631) (30,396) Net loss per share, basic and diluted $ (0.99) $ (0.65) $ (0.91) $ (0.62) 2018 Revenue $ 4,695 $ 18,834 $ 20,798 $ 15,794 Net loss (49,536) (43,244) (34,029) (44,644) Net loss per share, basic and diluted $ (1.34) $ (1.03) $ (0.81) $ (1.06) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 12 Months Ended | |||
Dec. 31, 2019USD ($)Segment | Dec. 31, 2018USD ($) | Jan. 01, 2019USD ($) | Dec. 31, 2017USD ($) | |
Accounting Policies [Abstract] | ||||
Number of operating segments | Segment | 1 | |||
Available-for-sale securities, other than temporary impairment losses | $ 0 | $ 0 | ||
Allowance recorded | 0 | 0 | ||
Impaired assets | 0 | $ 0 | $ 0 | |
Operating lease, ROU Assets | 20,200,000 | $ 16,400,000 | ||
Operating lease liabilities | $ 30,573,000 | $ 27,700,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Fair Value Measurement Financial Asset and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Assets [Abstract] | ||
Cash and cash equivalents | $ 73,200 | $ 146,200 |
Securities | 89,284 | |
Total assets measured at fair value | 162,506 | 160,849 |
Money market funds | ||
Assets [Abstract] | ||
Cash and cash equivalents | 46,149 | 46,257 |
Government-sponsored enterprises | ||
Assets [Abstract] | ||
Marketable securities | 13,222 | |
U.S Treasury securities | ||
Assets [Abstract] | ||
Marketable securities | 12,488 | |
Corporate debt securities | ||
Assets [Abstract] | ||
Marketable securities | 100,214 | |
Securities | 103,135 | |
Common stock warrants | ||
Assets [Abstract] | ||
Common stock warrants | 1,890 | |
Quoted Prices in Active Markets for Identical Assets, Level 1 | ||
Assets [Abstract] | ||
Total assets measured at fair value | 46,149 | 46,257 |
Quoted Prices in Active Markets for Identical Assets, Level 1 | Money market funds | ||
Assets [Abstract] | ||
Cash and cash equivalents | 46,149 | 46,257 |
Quoted Prices in Active Markets for Identical Assets, Level 1 | Government-sponsored enterprises | ||
Assets [Abstract] | ||
Marketable securities | 0 | |
Quoted Prices in Active Markets for Identical Assets, Level 1 | U.S Treasury securities | ||
Assets [Abstract] | ||
Marketable securities | 0 | |
Quoted Prices in Active Markets for Identical Assets, Level 1 | Corporate debt securities | ||
Assets [Abstract] | ||
Marketable securities | 0 | |
Securities | 0 | |
Quoted Prices in Active Markets for Identical Assets, Level 1 | Common stock warrants | ||
Assets [Abstract] | ||
Common stock warrants | 0 | |
Significant Other Observable Inputs, Level 2 | ||
Assets [Abstract] | ||
Total assets measured at fair value | 116,357 | 112,702 |
Significant Other Observable Inputs, Level 2 | Money market funds | ||
Assets [Abstract] | ||
Cash and cash equivalents | 0 | 0 |
Significant Other Observable Inputs, Level 2 | Government-sponsored enterprises | ||
Assets [Abstract] | ||
Marketable securities | 13,222 | |
Significant Other Observable Inputs, Level 2 | U.S Treasury securities | ||
Assets [Abstract] | ||
Marketable securities | 12,488 | |
Significant Other Observable Inputs, Level 2 | Corporate debt securities | ||
Assets [Abstract] | ||
Marketable securities | 100,214 | |
Securities | 103,135 | |
Significant Other Observable Inputs, Level 2 | Common stock warrants | ||
Assets [Abstract] | ||
Common stock warrants | 0 | |
Significant Unobservable Inputs, Level 3 | ||
Assets [Abstract] | ||
Total assets measured at fair value | 0 | 1,890 |
Significant Unobservable Inputs, Level 3 | Money market funds | ||
Assets [Abstract] | ||
Cash and cash equivalents | 0 | 0 |
Significant Unobservable Inputs, Level 3 | Government-sponsored enterprises | ||
Assets [Abstract] | ||
Marketable securities | 0 | |
Significant Unobservable Inputs, Level 3 | U.S Treasury securities | ||
Assets [Abstract] | ||
Marketable securities | 0 | |
Significant Unobservable Inputs, Level 3 | Corporate debt securities | ||
Assets [Abstract] | ||
Marketable securities | 0 | |
Securities | $ 0 | |
Significant Unobservable Inputs, Level 3 | Common stock warrants | ||
Assets [Abstract] | ||
Common stock warrants | $ 1,890 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Collaborators that Represent More Than 10% of Total Revenue Earned and Accounts Receivable (Details) - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Sales revenue, net | Incyte Corporation (Incyte) | |||
Concentration Risk [Line Items] | |||
Percentage of significant accounts receivable | 35.00% | 68.00% | 96.00% |
Sales revenue, net | Zai Lab Limited (Zai Lab) | |||
Concentration Risk [Line Items] | |||
Percentage of significant accounts receivable | 29.00% | ||
Sales revenue, net | Les Laboratoires Servier and Institut de Recherches Servier (Servier) | |||
Concentration Risk [Line Items] | |||
Percentage of significant accounts receivable | 18.00% | ||
Accounts receivable | Incyte Corporation (Incyte) | |||
Concentration Risk [Line Items] | |||
Percentage of significant accounts receivable | 62.00% | 16.00% | |
Accounts receivable | Zai Lab Limited (Zai Lab) | |||
Concentration Risk [Line Items] | |||
Percentage of significant accounts receivable | 23.00% | 76.00% |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Estimated Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Software | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Furniture | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 10 years |
Laboratory and office equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Antidilutive Securities Excluded from the Calculation of Diluted Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock options and RSUs | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive stock options | 7,159,494 | 5,273,964 | 4,504,642 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Adoption of 606 (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 01, 2018 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Deferred revenue, current | $ 10,700 | $ 21,721 | $ 10,700 | $ 21,721 | ||||||||
Deferred revenue, net of current portion | 9,153 | 19,001 | 9,153 | 19,001 | ||||||||
Accumulated deficit | (642,082) | (490,271) | (642,082) | (490,271) | ||||||||
Revenues | 25,192 | $ 18,741 | $ 10,593 | $ 9,662 | 15,794 | $ 20,798 | $ 18,834 | $ 4,695 | 64,188 | 60,121 | $ 157,742 | |
Net loss | $ (30,396) | $ (44,631) | $ (31,767) | $ (45,017) | (44,644) | $ (34,029) | $ (43,244) | $ (49,536) | $ (151,811) | $ (171,453) | $ (19,626) | |
Basic and diluted net loss per common share (in usd per share) | $ (3.16) | $ (4.19) | $ (0.54) | |||||||||
Accounting Standards Update 2014-09 | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Deferred revenue, current | 21,721 | $ 21,721 | $ 7,742 | |||||||||
Deferred revenue, net of current portion | 19,001 | 19,001 | 19,576 | |||||||||
Accumulated deficit | (490,271) | (490,271) | (318,818) | |||||||||
Net loss | $ (171,453) | |||||||||||
Basic and diluted net loss per common share (in usd per share) | $ (4.19) | |||||||||||
Accounting Standards Update 2014-09 | Pre-Adoption | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Deferred revenue, current | 22,210 | $ 22,210 | 7,202 | |||||||||
Deferred revenue, net of current portion | 12,573 | 12,573 | 13,637 | |||||||||
Accumulated deficit | (484,332) | (484,332) | (312,340) | |||||||||
Net loss | $ (171,993) | |||||||||||
Basic and diluted net loss per common share (in usd per share) | $ (4.20) | |||||||||||
Accounting Standards Update 2014-09 | ASC 606 Adjustment | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Deferred revenue, current | (489) | $ (489) | 540 | |||||||||
Deferred revenue, net of current portion | 6,428 | 6,428 | 5,939 | |||||||||
Accumulated deficit | $ (5,939) | (5,939) | $ (6,478) | |||||||||
Net loss | $ (540) | |||||||||||
Basic and diluted net loss per common share (in usd per share) | $ 0.01 | |||||||||||
Revenue from collaborative agreements | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Revenues | $ 62,024 | $ 58,644 | $ 155,516 | |||||||||
Revenue from collaborative agreements | Accounting Standards Update 2014-09 | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Revenues | 58,644 | |||||||||||
Revenue from collaborative agreements | Accounting Standards Update 2014-09 | Pre-Adoption | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Revenues | 58,104 | |||||||||||
Revenue from collaborative agreements | Accounting Standards Update 2014-09 | ASC 606 Adjustment | ||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||
Revenues | $ 540 |
Summary of Signficant Accountin
Summary of Signficant Accounting Policies - Contract With Customer Liability (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Accounting Policies [Abstract] | |
Beginning balance | $ 27,318 |
Additions | 22,992 |
Deductions | (9,588) |
Ending balance | 40,722 |
Increase in revenue recognized from ASC 606 adoption | $ 9,588 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 89,268 | |
Gross Unrealized Gains | 26 | |
Gross Unrealized Losses | (10) | |
Fair Value | 89,284 | |
Government-sponsored enterprises | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 13,216 | |
Gross Unrealized Gains | 6 | |
Gross Unrealized Losses | 0 | |
Fair Value | 13,222 | |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 76,052 | $ 12,738 |
Gross Unrealized Gains | 20 | 0 |
Gross Unrealized Losses | (10) | (3) |
Fair Value | $ 76,062 | $ 12,735 |
Marketable Securities - Availab
Marketable Securities - Available-For-Sale Securities (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |||
Available-for-sale securities, other than temporary impairment losses | $ 0 | $ 0 | |
Interest Income, Other | $ 3,400,000 | $ 2,300,000 | $ 2,400,000 |
Property, Equipment and Softw_3
Property, Equipment and Software (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Line Items] | |||
Property, equipment and software | $ 97,936,000 | $ 94,647,000 | |
Construction in progress | 187,000 | 218,000 | |
Less accumulated depreciation and amortization | (49,725,000) | (37,935,000) | |
Property, equipment and software, net | 48,211,000 | 56,712,000 | |
Property and equipment purchased but not yet paid | 100,000 | 600,000 | |
Depreciation expense | 12,300,000 | 9,200,000 | $ 7,000,000 |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, equipment and software | 2,430,000 | 2,360,000 | |
Software | |||
Property, Plant and Equipment [Line Items] | |||
Property, equipment and software | 7,513,000 | 7,011,000 | |
Furniture and office equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, equipment and software | 713,000 | 668,000 | |
Motor Vehicles | |||
Property, Plant and Equipment [Line Items] | |||
Property, equipment and software | 50,000 | 0 | |
Lab equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, equipment and software | 38,368,000 | 36,062,000 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property, equipment and software | $ 48,675,000 | $ 48,328,000 |
Leases Narrative (Details)
Leases Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Jan. 01, 2019 | |
Lessee, Lease, Description [Line Items] | ||
Lease renewal term (in years) | 5 years | |
Weighted average lease term (in years) | 5 years 7 months 6 days | |
Discount rate | 9.90% | |
Operating lease payments | $ 6.4 | |
Operating lease, ROU Assets | $ 20.2 | $ 16.4 |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Lease renewal term (in years) | 5 years | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Lease renewal term (in years) | 14 years |
Lease Costs (Details)
Lease Costs (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 5,463 |
Variable lease cost | 1,366 |
Sublease income | (942) |
Net lease cost | $ 5,887 |
Maturities of Operating Lease L
Maturities of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
Leases [Abstract] | ||
2020 | $ 5,913 | |
2021 | 6,507 | |
2022 | 6,688 | |
2023 | 6,536 | |
2024 | 5,588 | |
Thereafter | 11,068 | |
Total lease payments | 42,300 | |
Present value adjustment | (11,727) | |
Lease liabilities | $ 30,573 | $ 27,700 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 02, 2018 | May 03, 2017 | Apr. 26, 2017 | Feb. 28, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Class of Stock [Line Items] | |||||||
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 | |||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | |||||
Proceeds from issuance of common stock, net of offering costs | $ 118,657 | $ 103,259 | $ 34,244 | ||||
Undesignated Preferred Stock | |||||||
Class of Stock [Line Items] | |||||||
Undesignated preferred stock, shares authorized (in shares) | 5,000,000 | ||||||
Undesignated preferred stock, par value (in dollars per share) | $ 0.01 | ||||||
Undesignated preferred stock, shares issued (in shares) | 0 | 0 | |||||
Undesignated preferred stock, shares outstanding (in shares) | 0 | 0 | |||||
Registered Direct Offering | |||||||
Class of Stock [Line Items] | |||||||
Issuance of common stock, net of offering costs (in shares) | 1,100,000 | ||||||
Number of shares issued or sold (in shares) | 1,100,000 | ||||||
Common stock purchase price (in dollars per share) | $ 21.50 | ||||||
Proceeds from issuance of common stock, net of offering costs | $ 23,700 | ||||||
At The Market Offering | |||||||
Class of Stock [Line Items] | |||||||
Issuance of common stock, net of offering costs (in shares) | 599,284 | ||||||
Number of shares issued or sold (in shares) | 599,284 | ||||||
Common stock maximum amount available for issuance | $ 75,000 | ||||||
Proceeds of stock sale | $ 10,800 | ||||||
Firm Commitment Public Underwritten Offer | |||||||
Class of Stock [Line Items] | |||||||
Sale of common stock (in shares) | 4,500,000 | ||||||
Sale of common stock (in dollars per share) | $ 21.25 | ||||||
Proceeds of stock sale | $ 103,300 | ||||||
Over-Allotment Option | |||||||
Class of Stock [Line Items] | |||||||
Issuance of common stock, net of offering costs (in shares) | 825,000 | ||||||
Number of shares issued or sold (in shares) | 825,000 | ||||||
Common stock purchase price (in dollars per share) | $ 20 | ||||||
Sale of common stock (in shares) | 675,000 | ||||||
Sale of common stock (in dollars per share) | $ 21.25 | ||||||
Follow-On Equity Offering | |||||||
Class of Stock [Line Items] | |||||||
Issuance of common stock, net of offering costs (in shares) | 5,500,000 | ||||||
Number of shares issued or sold (in shares) | 5,500,000 | ||||||
Common stock purchase price (in dollars per share) | $ 20 | ||||||
Proceeds from issuance of common stock, net of offering costs | $ 118,700 |
Stock-based Compensation - Empl
Stock-based Compensation - Employee Stock Purchase Plan (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
May 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | May 18, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Proceeds from issuance of common stock, net of offering costs | $ 118,657 | $ 103,259 | $ 34,244 | ||
2016 Employee Stock Purchase Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based compensation, number of shares authorized (in shares) | 800,000 | ||||
Maximum employee contribution percent | 10.00% | ||||
Percent of fair market value to purchase shares | 85.00% | ||||
Common stock purchased by employees (in shares) | 61,417 | ||||
Proceeds from issuance of common stock, net of offering costs | $ 700 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Oct. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation arrangement by share-based payment award, options, outstanding, number (in shares) | 6,706,994 | 5,273,964 | ||
Weighted average exercise price (in dollars per share) | $ 22.33 | $ 22.23 | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 19,571 | $ 16,520 | $ 14,744 | |
Equity Incentive Plan 2003 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation arrangement by share-based payment award, options, outstanding, number (in shares) | 550,572 | |||
Weighted average exercise price (in dollars per share) | $ 2.32 | |||
Stock Incentive Plan 2013 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation, number of shares authorized (in shares) | 1,960,168 | |||
Increased number of shares authorized (in shares) | 9,932,263 | |||
Share-based compensation arrangement by share-based payment award, options, outstanding, number (in shares) | 6,156,422 | |||
Weighted average exercise price (in dollars per share) | $ 24.12 | |||
Minimum annual increase (in shares) | 1,960,168 | |||
Percentage of common stock share outstanding | 4.00% | |||
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 10,023 | 7,919 | 7,388 | |
General and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 9,548 | $ 8,601 | $ 7,356 |
Stock-based Compensation - Opti
Stock-based Compensation - Option Pricing Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected term | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 74.00% | 68.00% | 67.00% |
Risk-free interest rate | 1.40% | 2.40% | 1.90% |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 76.00% | 72.00% | 68.00% |
Risk-free interest rate | 2.60% | 3.10% | 2.30% |
Options granted, maximum term | 10 years |
Stock-based Compensation - St_2
Stock-based Compensation - Stock Option and Restricted Stock Unit Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Shares | |||
Beginning Balance (in shares) | 5,273,964 | ||
Granted (in shares) | 1,946,770 | ||
Exercised (in shares) | (219,045) | ||
Forfeited or expired (in shares) | (294,695) | ||
Ending Balance (in shares) | 6,706,994 | 5,273,964 | |
Exercisable (in shares) | 4,298,178 | ||
Vested and expected to vest (in shares) | 6,446,218 | ||
Weighted-Average Exercise Price | |||
Beginning Balance (in dollars per share) | $ 22.23 | ||
Granted (in dollars per share) | 20.81 | ||
Exercised (in dollars per share) | 3.03 | ||
Forfeited or expired (in dollars per share) | 24.72 | ||
Ending Balance (in dollars per share) | 22.33 | $ 22.23 | |
Exercisable (in dollars per share) | 22.21 | ||
Vested and expected to vest (in dollars per share) | $ 22.31 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Weighted-average remaining contractual term, Outstanding | 6 years 10 months 24 days | 6 years 9 months 18 days | |
Weighted-average remaining contractual term, Exercisable | 5 years 10 months 24 days | ||
Weighted-average remaining contractual term, Vested and expected to vest | 6 years 10 months 24 days | ||
Aggregate intrinsic value, Outstanding | $ 4,749 | ||
Aggregate intrinsic value, Exercisable | 4,712 | ||
Aggregate intrinsic value, Vested and expected to vest | $ 4,746 | ||
Weighted-Average Grant Date Fair Value | |||
Common stock, shares issued (in shares) | 219,045 | 274,362 | 253,036 |
Cash proceeds from exercise of stock options | $ 700 | $ 900 | $ 500 |
Weighted-average grant-date fair value of options granted (in dollars per share) | $ 13.98 | $ 17.90 | $ 12.53 |
Share-based compensation arrangement by share-based payment award, options, exercises in period, intrinsic value | $ 2,900 | $ 5,200 | $ 4,200 |
Fair value of shares vested | 17,700 | $ 16,400 | $ 14,600 |
Unrecognized compensation cost related to non-vested stock-based compensation arrangements | $ 30,200 | ||
Unrecognized compensation expense recognition period | 2 years 7 months 6 days | ||
Stock Incentive Plan 2013 | |||
Shares | |||
Ending Balance (in shares) | 6,156,422 | ||
Weighted-Average Exercise Price | |||
Ending Balance (in dollars per share) | $ 24.12 | ||
Restricted Stock Units | |||
Shares | |||
Beginning Balance (in shares) | 0 | ||
Granted (in shares) | 467,600 | ||
Exercised (in shares) | 0 | ||
Forfeited (in shares) | (15,100) | ||
Ending Balance (in shares) | 452,500 | 0 | |
Weighted-Average Grant Date Fair Value | |||
Beginning Balance (in dollars per share) | $ 0 | ||
Granted (in dollars per share) | 15.32 | ||
Exercised (in dollars per share) | 0 | ||
Forfeited or expired (in dollars per share) | 15.32 | ||
Ending Balance (in dollars per share) | $ 15.32 | $ 0 | |
Unrecognized compensation expense recognition period | 1 year 7 months 6 days | ||
Awards granted in period (in shares) | 467,600 | ||
Total unrecognized compensation cost | $ 5,300 | ||
Restricted Stock Units | Stock Incentive Plan 2013 | |||
Shares | |||
Granted (in shares) | 0 | 0 | |
Weighted-Average Grant Date Fair Value | |||
Awards granted in period (in shares) | 0 | 0 |
Income Taxes - Components of th
Income Taxes - Components of the Company's Deferred Tax Assets (Liabilities) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Provision for federal or state income taxes | $ 0 | $ 0 | $ 0 |
Deferred income tax assets: | |||
Federal U.S. net operating loss carryforward | 116,436,000 | 87,284,000 | |
State net operating loss carryforward | 31,110,000 | 22,809,000 | |
Research and development credit, net | 35,580,000 | 29,750,000 | |
Orphan drug credit, net | 22,881,000 | 22,580,000 | |
Operating lease liabilities | 8,413,000 | 0 | |
Deferred revenue | 367,000 | 3,736,000 | |
Other | 9,123,000 | 9,972,000 | |
Gross deferred income tax assets | 223,910,000 | 176,131,000 | |
Valuation allowance | (214,893,000) | (172,457,000) | |
Net deferred income tax assets | 9,017,000 | 3,674,000 | |
Deferred income tax liabilities: | |||
Depreciation | (438,000) | (1,911,000) | |
Operating lease ROU assets | (5,547,000) | 0 | |
Prepaid expenditures | (3,032,000) | (1,763,000) | |
Gross deferred income tax liabilities | (9,017,000) | (3,674,000) | |
Net deferred income tax asset/(liability) | 0 | $ 0 | |
Operating Loss Carryforwards [Line Items] | |||
Remaining portion of net operating losses | 541,000,000 | ||
U.S. Federal and State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 554,500,000 | ||
U.S. Federal Government | |||
Operating Loss Carryforwards [Line Items] | |||
US Federal tax credits carry forward | 58,200,000 | ||
Net operating loss for limited use | 13,500,000 | ||
U.S. Federal Government | Minimum | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating losses limited for use utilized on an annual basis | 200,000 | ||
U.S. Federal Government | Maximum | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating losses limited for use utilized on an annual basis | 1,400,000 | ||
Tax Year 2025 To 2037 | U.S. Federal and State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 237,800,000 | ||
Indefinite | U.S. Federal and State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 316,700,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Reported Estimated Income Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
United States federal tax at statutory rate | $ (31,880) | $ (36,005) | $ (6,869) |
State taxes (net of federal benefit) | (9,524) | (11,133) | (735) |
Deferred income tax adjustments | 2,004 | (4,435) | 607 |
Deferred state blended rate adjustments | 0 | 0 | (485) |
Deferred federal rate change reduction in corporate rate | 0 | 0 | 39,447 |
Research credit, net | (5,830) | (8,466) | (8,455) |
Orphan drug credit, net | (301) | (872) | (1,853) |
Other permanent items | 1,206 | 148 | 276 |
Equity-based compensation | 1,889 | 758 | 2,067 |
Change in valuation allowance | 42,436 | 60,005 | (24,000) |
Income tax expense/(benefit) | $ 0 | $ 0 | $ 0 |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of the Beginning and Ending Amount of Gross Unrecognized Tax Benefits (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Beginning balance | $ 4,318,000 | $ 3,395,000 | $ 2,465,000 |
Increases for current year tax positions | 637,000 | 642,000 | 569,000 |
Decreases for prior year tax positions | (5,000) | ||
Increases for prior year tax positions | 281,000 | 361,000 | |
Ending balance | 4,950,000 | 4,318,000 | 3,395,000 |
Gross unrecognized tax benefits | 4,900,000 | 4,300,000 | |
Unrecognized interest or penalties | $ 0 | $ 0 | $ 0 |
Collaboration and Other Agree_2
Collaboration and Other Agreements, Incyte Corporation (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Oct. 31, 2017USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Jan. 01, 2018performance_obligation | |
Collaboration and Other Agreements [Line Items] | |||||||||||||
Revenues | $ 25,192 | $ 18,741 | $ 10,593 | $ 9,662 | $ 15,794 | $ 20,798 | $ 18,834 | $ 4,695 | $ 64,188 | $ 60,121 | $ 157,742 | ||
Incyte MGA012 Agreement | Incyte Corporation (Incyte) | |||||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||||
Non-refundable upfront payment | $ 150,000 | ||||||||||||
Amounts recognized | 15,000 | ||||||||||||
Number of performance obligations | performance_obligation | 2 | ||||||||||||
Transaction price | $ 154,000 | ||||||||||||
Clinical trial activities selling price amount | 4,000 | ||||||||||||
Maximum | Incyte MGA012 Agreement | Incyte Corporation (Incyte) | |||||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||||
Potential development and regulatory milestone payments | 420,000 | ||||||||||||
Potential commercial milestone payments | $ 330,000 | ||||||||||||
Potential proceeds from royalties percent | 24.00% | ||||||||||||
Minimum | Incyte MGA012 Agreement | Incyte Corporation (Incyte) | |||||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||||
Potential proceeds from royalties percent | 15.00% | ||||||||||||
Revenues From License Agreements | Incyte MGA012 Agreement | Incyte Corporation (Incyte) | |||||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||||
Revenues | 100 | 18,800 | |||||||||||
Revenues From License Agreements | Incyte MGA012 Clinical Services | Incyte Corporation (Incyte) | |||||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||||
Revenues | $ 22,100 | $ 22,200 |
Collaboration and Other Agree_3
Collaboration and Other Agreements, Servier (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Sep. 30, 2012 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Collaboration and Other Agreements [Line Items] | |||||||||||||
Revenues | $ 25,192 | $ 18,741 | $ 10,593 | $ 9,662 | $ 15,794 | $ 20,798 | $ 18,834 | $ 4,695 | $ 64,188 | $ 60,121 | $ 157,742 | ||
Deferred revenue | 40,722 | 40,722 | 27,318 | ||||||||||
Servier | Servier DART | |||||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||||
Non-refundable upfront payment | $ 20,000 | ||||||||||||
Milestone payment removed | $ 5,000 | ||||||||||||
Deferred revenue | 1,000 | 1,000 | |||||||||||
Deferred revenue, current | $ 1,000 | 1,000 | |||||||||||
Option exercise fee | $ 15,000 | ||||||||||||
Offset to research and development costs under collaboration arrangement | 3,600 | 6,000 | 3,200 | ||||||||||
Revenues From License Agreements | Servier | Servier DART | |||||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||||
Revenues | 11,600 | 1,200 | 1,400 | ||||||||||
Revenues From License Agreements | Servier | Servier Agreement - MGD007 Option | |||||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||||
Revenues | $ 0 | 1,900 | $ 1,100 | ||||||||||
Deferred revenue | $ 0 | $ 0 |
Collaboration and Other Agree_4
Collaboration and Other Agreements, Zai Lab (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||
Nov. 30, 2018 | Oct. 31, 2017 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Feb. 29, 2020 | |
Collaboration and Other Agreements [Line Items] | ||||||||||||||
Revenues | $ 25,192 | $ 18,741 | $ 10,593 | $ 9,662 | $ 15,794 | $ 20,798 | $ 18,834 | $ 4,695 | $ 64,188 | $ 60,121 | $ 157,742 | |||
Deferred revenue | $ 40,722 | 40,722 | $ 27,318 | |||||||||||
Zai Lab Agreement | Zai Lab | ||||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||||
Non-refundable upfront payment | $ 25,000 | |||||||||||||
Tax withholding | $ 2,500 | |||||||||||||
Potential development and regulatory milestone payments | 140,000 | 140,000 | ||||||||||||
Revenues | 16,100 | $ 1,300 | ||||||||||||
Deferred revenue | $ 5,000 | 5,000 | ||||||||||||
Zai Lab Agreement | Zai Lab | Subsequent Event | ||||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||||
Entitled milestone payments | $ 4,000 | |||||||||||||
Zai Lab Agreement, Margetuximab | Zai Lab | Maximum | ||||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||||
Potential proceeds from royalties percent | 20.00% | |||||||||||||
Zai Lab Agreement, TRIDENT molecule | Zai Lab | ||||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||||
Potential proceeds from royalties percent | 10.00% | |||||||||||||
Zai Lab Clinical Supply Agreements | Zai Lab | ||||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||||
Revenues | $ 2,200 |
Collaboration and Other Agree_5
Collaboration and Other Agreements, I-Mab Biopharma (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Collaboration and Other Agreements [Line Items] | |||||||||||
Revenues | $ 25,192 | $ 18,741 | $ 10,593 | $ 9,662 | $ 15,794 | $ 20,798 | $ 18,834 | $ 4,695 | $ 64,188 | $ 60,121 | $ 157,742 |
Deferred revenue | $ 40,722 | $ 40,722 | $ 27,318 | ||||||||
I-Mab Biopharma Collaboration And License Agreement | I-Mab | |||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||
Non-refundable upfront payment | 15,000 | ||||||||||
Potential development and regulatory milestone payments | 135,000 | 135,000 | |||||||||
Estimated variable consideration | 1,000 | ||||||||||
Revenues | 2,300 | ||||||||||
Deferred revenue | 13,500 | 13,500 | |||||||||
Deferred revenue, current | 4,400 | 4,400 | |||||||||
Deferred revenue, noncurrent | $ 9,100 | $ 9,100 |
Collaboration and Other Agree_6
Collaboration and Other Agreements, Roche (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Jan. 31, 2018USD ($) | Dec. 31, 2017USD ($)performance_obligation | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($)performance_obligation | |
Collaboration and Other Agreements [Line Items] | |||||||||||||
Revenues | $ 25,192,000 | $ 18,741,000 | $ 10,593,000 | $ 9,662,000 | $ 15,794,000 | $ 20,798,000 | $ 18,834,000 | $ 4,695,000 | $ 64,188,000 | $ 60,121,000 | $ 157,742,000 | ||
Deferred revenue | $ 27,318,000 | 40,722,000 | 40,722,000 | $ 27,318,000 | |||||||||
Deferred revenue, current | 10,700,000 | 21,721,000 | 10,700,000 | 21,721,000 | |||||||||
Deferred revenue included in long-term liabilities | 9,153,000 | 19,001,000 | 9,153,000 | 19,001,000 | |||||||||
Roche | |||||||||||||
Collaboration and Other Agreements [Line Items] | |||||||||||||
Non-refundable upfront payment | $ 10,000,000 | ||||||||||||
Potential milestone payments and royalties on future sales | 370,000,000 | 370,000,000 | |||||||||||
Number of performance obligations | performance_obligation | 1 | 1 | |||||||||||
Transaction price | $ 10,000,000 | $ 10,000,000 | |||||||||||
Expected period of development | 30 months | ||||||||||||
Revenues | 6,000,000 | 4,000,000 | |||||||||||
Deferred revenue | $ 0 | $ 0 | |||||||||||
Deferred revenue | 6,000,000 | 6,000,000 | |||||||||||
Deferred revenue, current | 4,000,000 | 4,000,000 | |||||||||||
Deferred revenue included in long-term liabilities | $ 2,000,000 | $ 2,000,000 |
Collaboration and Other Agree_7
Collaboration and Other Agreements, Provention (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
May 31, 2018USD ($)performance_obligation$ / sharesshares | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Collaboration and Other Agreements [Line Items] | ||||||||||||
Revenues | $ 25,192 | $ 18,741 | $ 10,593 | $ 9,662 | $ 15,794 | $ 20,798 | $ 18,834 | $ 4,695 | $ 64,188 | $ 60,121 | $ 157,742 | |
Deferred revenue | 10,700 | 21,721 | 10,700 | 21,721 | ||||||||
Deferred revenue included in long-term liabilities | 9,153 | 19,001 | 9,153 | 19,001 | ||||||||
Provention Bio, Inc. (Provention) | ||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||
Number of performance obligations | performance_obligation | 2 | |||||||||||
Transaction price | $ 6,100 | |||||||||||
Stock warrants (in shares) | shares | 2,432,688 | |||||||||||
Green Cross | ||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||
Deferred revenue | $ 1,900 | $ 1,900 | ||||||||||
Deferred revenue included in long-term liabilities | $ 20,100 | $ 20,100 | ||||||||||
Provention License Agreement | Provention PRV3279 | Provention Bio, Inc. (Provention) | ||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||
Consideration received common stock warrant exercise price (in usd per share) | $ / shares | $ 2.50 | |||||||||||
Potential development and regulatory milestone payments | $ 65,000 | |||||||||||
Potential commercial milestone payments | $ 225,000 | |||||||||||
Asset Purchase Agreement | Provention PRV031 | Provention Bio, Inc. (Provention) | ||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||
Consideration received common stock warrant exercise price (in usd per share) | $ / shares | $ 2.50 | |||||||||||
Potential development and regulatory milestone payments | $ 170,000 | |||||||||||
Potential commercial milestone payments | 225,000 | |||||||||||
Potential milestone payment to third parties for intellectual property under agreement | 1,300 | |||||||||||
Revenues From License Agreements | Provention Bio, Inc. (Provention) | ||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||
Revenues | $ 6,100 |
Collaboration and Other Agree_8
Collaboration and Other Agreements, NIAID Contract (Details) | Sep. 15, 2015USD ($)Molecule | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Collaboration and Other Agreements [Line Items] | ||||||||||||
Revenues | $ 25,192,000 | $ 18,741,000 | $ 10,593,000 | $ 9,662,000 | $ 15,794,000 | $ 20,798,000 | $ 18,834,000 | $ 4,695,000 | $ 64,188,000 | $ 60,121,000 | $ 157,742,000 | |
NIAID | ||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||
Commercialization of molecules | Molecule | 2 | |||||||||||
Base period value | $ 7,500,000 | |||||||||||
Proceeds from additional development funding options under agreement | 10,800,000 | |||||||||||
NIAID | Maximum | ||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||
Additional development funding options | 17,000,000 | |||||||||||
Total potential value | $ 24,500,000 | |||||||||||
Revenues From License Agreements | NIAID | ||||||||||||
Collaboration and Other Agreements [Line Items] | ||||||||||||
Revenues | $ 2,200,000 | $ 1,300,000 | $ 1,700,000 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2013 | |
Retirement Benefits [Abstract] | ||||
Eligible age to participate in plan | 21 years | |||
Percentage of employee contribution to salary | 100.00% | |||
Percentage of employee vested contribution | 100.00% | |||
Defined contribution plan, employer discretionary contribution amount | $ 1.4 | $ 1.3 | $ 1.1 |
Quarterly Financial Informati_3
Quarterly Financial Information (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 25,192 | $ 18,741 | $ 10,593 | $ 9,662 | $ 15,794 | $ 20,798 | $ 18,834 | $ 4,695 | $ 64,188 | $ 60,121 | $ 157,742 |
Net loss | $ (30,396) | $ (44,631) | $ (31,767) | $ (45,017) | $ (44,644) | $ (34,029) | $ (43,244) | $ (49,536) | $ (151,811) | $ (171,453) | $ (19,626) |
Net loss per share, basic and diluted (in usd per share) | $ (0.62) | $ (0.91) | $ (0.65) | $ (0.99) | $ (1.06) | $ (0.81) | $ (1.03) | $ (1.34) |
Uncategorized Items - mgnx-2019
Label | Element | Value |
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ (6,478,000) |
Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ (6,478,000) |