Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 03, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36112 | |
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 $0.01 per share | |
Trading Symbol | MGNX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 61,458,790 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001125345 | |
Current Fiscal Year End Date | --12-31 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 21,469 | $ 123,469 |
Marketable securities | 112,271 | 120,147 |
Accounts receivable | 18,385 | 10,386 |
Inventory, net | 2,949 | 4,388 |
Prepaid expenses and other current assets | 12,559 | 21,170 |
Total current assets | 167,633 | 279,560 |
Property, equipment and software, net | 34,022 | 37,676 |
Other non current assets | 16,388 | 18,009 |
Total assets | 218,043 | 335,245 |
Current liabilities: | ||
Accounts payable | 2,609 | 15,500 |
Accrued expenses and other current liabilities | 31,763 | 33,755 |
Deferred revenue | 11,565 | 20,646 |
Lease liabilities | 4,940 | 4,677 |
Total current liabilities | 50,877 | 74,578 |
Deferred revenue, net of current portion | 6,163 | 0 |
Lease liabilities, net of current portion | 18,264 | 20,791 |
Other non current liabilities | 258 | 258 |
Total liabilities | 75,562 | 95,627 |
Stockholders' equity: | ||
Common stock, $0.01 par value -- 125,000,000 shares authorized, 61,458,790 and 61,307,428 shares outstanding at June 30, 2022 and December 31, 2021, respectively | 615 | 613 |
Additional paid-in capital | 1,223,875 | 1,213,002 |
Accumulated other comprehensive loss | (326) | (61) |
Accumulated deficit | (1,081,683) | (973,936) |
Total stockholders' equity | 142,481 | 239,618 |
Total liabilities and stockholders' equity | $ 218,043 | $ 335,245 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Stockholders' equity: | ||
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) | 61,458,790 | 61,307,428 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues: | ||||
Revenues | $ 26,007 | $ 30,757 | $ 37,108 | $ 47,638 |
Costs and expenses: | ||||
Cost of product sales | 180 | 22 | 228 | 39 |
Cost of manufacturing services | 2,222 | 0 | 2,222 | 0 |
Research and development | 51,744 | 55,780 | 113,182 | 108,901 |
Selling, general and administrative | 13,669 | 15,234 | 29,922 | 30,270 |
Total costs and expenses | 67,815 | 71,036 | 145,554 | 139,210 |
Loss from operations | (41,808) | (40,279) | (108,446) | (91,572) |
Other income | 504 | 344 | 699 | 365 |
Net loss | (41,304) | (39,935) | (107,747) | (91,207) |
Other comprehensive loss: | ||||
Unrealized gain (loss) on investments | (43) | (10) | (265) | 8 |
Comprehensive loss | $ (41,347) | $ (39,945) | $ (108,012) | $ (91,199) |
Basic net loss per common share (in usd per share) | $ (0.67) | $ (0.66) | $ (1.76) | $ (1.56) |
Diluted net loss per common share (in usd per share) | $ (0.67) | $ (0.66) | $ (1.76) | $ (1.56) |
Basic weighted average common shares outstanding (in shares) | 61,384,943 | 60,068,315 | 61,354,721 | 58,643,496 |
Diluted weighted average common shares outstanding (in shares) | 61,384,943 | 60,068,315 | 61,354,721 | 58,643,496 |
Collaborative and other agreements | ||||
Revenues: | ||||
Revenues | $ 16,863 | $ 27,168 | $ 23,956 | $ 42,352 |
Product sales, net | ||||
Revenues: | ||||
Revenues | 4,672 | 3,203 | 8,252 | 4,090 |
Government agreements | ||||
Revenues: | ||||
Revenues | 480 | 386 | 908 | 1,196 |
Contract Manufacturing | ||||
Revenues: | ||||
Revenues | $ 3,992 | $ 0 | $ 3,992 | $ 0 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) |
Beginning balance (in shares) at Dec. 31, 2020 | 56,244,771 | ||||
Beginning balance at Dec. 31, 2020 | $ 295,884 | $ 562 | $ 1,067,150 | $ (771,821) | $ (7) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 5,243 | 5,243 | |||
Stock plan activity (in shares) | 144,249 | ||||
Stock plan related activity | 2,458 | $ 2 | 2,456 | ||
Issuance of common stock, net of offering costs (in shares) | 3,622,186 | ||||
Issuance of common stock, net of offering costs | 98,200 | $ 36 | 98,164 | ||
Unrealized gain (loss) on investments | 18 | 18 | |||
Net loss | (51,272) | (51,272) | |||
Ending balance (in shares) at Mar. 31, 2021 | 60,011,206 | ||||
Ending balance at Mar. 31, 2021 | 350,531 | $ 600 | 1,173,013 | (823,093) | 11 |
Beginning balance (in shares) at Dec. 31, 2020 | 56,244,771 | ||||
Beginning balance at Dec. 31, 2020 | 295,884 | $ 562 | 1,067,150 | (771,821) | (7) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (91,207) | ||||
Ending balance (in shares) at Jun. 30, 2021 | 60,133,447 | ||||
Ending balance at Jun. 30, 2021 | 319,045 | $ 601 | 1,181,471 | (863,028) | 1 |
Beginning balance (in shares) at Mar. 31, 2021 | 60,011,206 | ||||
Beginning balance at Mar. 31, 2021 | 350,531 | $ 600 | 1,173,013 | (823,093) | 11 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 6,113 | 6,113 | |||
Shares, Granted (in shares) | 122,241 | ||||
Stock plan related activity | 2,346 | $ 1 | 2,345 | ||
Unrealized gain (loss) on investments | (10) | (10) | |||
Net loss | (39,935) | (39,935) | |||
Ending balance (in shares) at Jun. 30, 2021 | 60,133,447 | ||||
Ending balance at Jun. 30, 2021 | 319,045 | $ 601 | 1,181,471 | (863,028) | 1 |
Beginning balance (in shares) at Dec. 31, 2021 | 61,307,428 | ||||
Beginning balance at Dec. 31, 2021 | 239,618 | $ 613 | 1,213,002 | (973,936) | (61) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 5,224 | 5,224 | |||
Stock plan activity (in shares) | 25,646 | ||||
Stock plan related activity | 37 | 37 | |||
Unrealized gain (loss) on investments | (222) | (222) | |||
Net loss | (66,443) | (66,443) | |||
Ending balance (in shares) at Mar. 31, 2022 | 61,333,074 | ||||
Ending balance at Mar. 31, 2022 | 178,214 | $ 613 | 1,218,263 | (1,040,379) | (283) |
Beginning balance (in shares) at Dec. 31, 2021 | 61,307,428 | ||||
Beginning balance at Dec. 31, 2021 | $ 239,618 | $ 613 | 1,213,002 | (973,936) | (61) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Shares, Granted (in shares) | 2,685,197 | ||||
Net loss | $ (107,747) | ||||
Ending balance (in shares) at Jun. 30, 2022 | 61,458,790 | ||||
Ending balance at Jun. 30, 2022 | 142,481 | $ 615 | 1,223,875 | (1,081,683) | (326) |
Beginning balance (in shares) at Mar. 31, 2022 | 61,333,074 | ||||
Beginning balance at Mar. 31, 2022 | 178,214 | $ 613 | 1,218,263 | (1,040,379) | (283) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 5,350 | 5,350 | |||
Shares, Granted (in shares) | 125,716 | ||||
Stock plan related activity | 264 | $ 2 | 262 | ||
Unrealized gain (loss) on investments | (43) | (43) | |||
Net loss | (41,304) | (41,304) | |||
Ending balance (in shares) at Jun. 30, 2022 | 61,458,790 | ||||
Ending balance at Jun. 30, 2022 | $ 142,481 | $ 615 | $ 1,223,875 | $ (1,081,683) | $ (326) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (107,747) | $ (91,207) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 5,790 | 5,510 |
Amortization of premiums and discounts on marketable securities | 628 | 808 |
Stock-based compensation | 10,574 | 11,356 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (7,999) | (22,166) |
Inventory | 362 | (6,476) |
Prepaid expenses and other current assets | 8,611 | (974) |
Other non current assets | 1,622 | 4,404 |
Accounts payable | (12,896) | 1,668 |
Accrued expenses and other current liabilities | (1,697) | 5,365 |
Lease liabilities | (2,264) | (1,673) |
Deferred revenue | (2,918) | 18,659 |
Net cash used in operating activities | (106,857) | (74,726) |
Cash flows from investing activities | ||
Purchases of marketable securities | (75,457) | (117,546) |
Proceeds from sale and maturities of marketable securities | 82,440 | 99,800 |
Purchases of property, equipment and software | (2,426) | (2,693) |
Net cash provided by (used in) investing activities | 4,557 | (20,439) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of offering costs | 0 | 98,200 |
Proceeds from stock option exercises and ESPP Purchases | 300 | 4,804 |
Net cash provided by financing activities | 300 | 103,004 |
Net change in cash and cash equivalents | (102,000) | 7,839 |
Cash and cash equivalents at beginning of period | 123,469 | 181,131 |
Cash and cash equivalents at end of period | 21,469 | 188,970 |
Supplemental Cash Flow Information [Abstract] | ||
Property, equipment and software included in accounts payable or accruals | 295 | 118 |
Other non-cash items | $ 1,077 | $ 0 |
Nature of Operations
Nature of Operations | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | Nature of Operations Description of the business MacroGenics, Inc. (the Company) is incorporated in the state of Delaware. The Company is a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics designed to modulate the human immune response for the treatment of cancer. The Company has a pipeline of product candidates being evaluated in clinical trials sponsored by the Company or its collaborators. These product candidates include multiple immuno-oncology programs, some of which were created primarily using the Company’s proprietary, antibody-based technology platforms. The Company believes its product candidates have the potential, if approved for marketing by regulatory authorities, to have a meaningful effect on treating patients' unmet medical needs as monotherapy or, in some cases, in combination with other therapeutic agents. In March 2021, the Company and its commercialization partner commenced U.S. marketing of MARGENZA (margetuximab-cmkb), a human epidermal growth factor receptor 2 (HER2) receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Liquidity The Company’s multiple product candidates currently under development will require significant additional research and development efforts that include extensive preclinical studies and clinical testing, and regulatory approval prior to commercial use. The future success of the Company is dependent on its ability to identify and develop its product candidates, and ultimately upon its ability to attain profitable operations. The Company has devoted substantially all of its financial resources and efforts to research and development and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on the Company’s stockholders’ equity and working capital, and accordingly, its ability to execute its future operating plans. As a biotechnology company, the Company has primarily funded its operations with proceeds from the sale of its common stock in equity offerings, revenue from its multiple collaboration agreements, and contracts and grants from the National Institute of Allergy and Infectious Diseases (NIAID). Management regularly reviews the Company’s available liquidity relative to its operating budget and forecast to monitor the sufficiency of the Company’s working capital. The Company plans to meet its future operating requirements by generating revenue from current and future strategic collaborations or other arrangements, and product sales. The Company anticipates continuing to draw upon available sources of capital, including equity and debt instruments, to support its product development activities. If the Company is unable to enter into new arrangements or to perform under current or future agreements or obtain additional capital, the Company will assess its capital resources and may be required to delay, reduce the scope of, or eliminate one or more of its product research and development programs or clinical studies, reduce other operating expenses, and/or downsize its organization. It is considered probable that the Company can successfully implement efforts to manage uncommitted spending and carry out necessary cost saving measures, including from our recently announced corporate restructuring plan. Therefore, based on the Company’s most recent cash flow forecast, the Company believes its current resources are sufficient to fund its operating plans for a minimum of twelve months from the date that this Quarterly Report on Form 10-Q was filed. Similar to the other risk factors pertinent to the Company's business, the COVID-19 pandemic and geopolitical tensions, including the ongoing military conflict between Russia and Ukraine and the related sanctions imposed against Russia, and related global slowdown of economic activity, decades-high inflation, rising interest rates and a potential recession in the United States might unfavorably impact the Company's ability to generate such additional funding. Given the uncertainty in the rapidly changing market and economic conditions related to these uncertainties, the Company will continue to evaluate the nature and extent of the impact of these uncertainties on its business and financial position. Basis of Presentation The accompanying unaudited interim consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that the management of the Company believes are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies During the six months ended June 30, 2022, there have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. Recent Accounting Pronouncements There were no new accounting pronouncements that were issued or became effective since the issuance of the Company’s 2021 Annual Report on Form 10-K that had, or are expected to have, a material impact on its consolidated financial position, results of operations or cash flows. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
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. There were no transfers between levels during the periods presented. Financial assets measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at June 30, 2022 Total Level 1 Level 2 Assets: Money market funds $ 8,162 $ 8,162 $ — U.S. Treasury securities 105,837 105,837 — Corporate debt securities 6,434 — 6,434 Total assets measured at fair value (a) $ 120,433 $ 113,999 $ 6,434 Fair Value Measurements at December 31, 2021 Total Level 1 Level 2 Assets: Money market funds $ 17,202 $ 17,202 $ — U.S. Treasury securities 81,132 81,132 — Government-sponsored enterprises 7,734 — 7,734 Corporate debt securities 37,280 — 37,280 Total assets measured at fair value (b) $ 143,348 $ 98,334 $ 45,014 (a) Total assets measured at fair value at June 30, 2022 includes approximately $8.2 million reported in cash and cash equivalents on the consolidated balance sheet. (b) Total assets measured at fair value at December 31, 2021 includes approximately $23.2 million reported in cash and cash equivalents on the consolidated balance sheet. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities The following tables summarize the Company's marketable debt securities (in thousands): June 30, 2022 Amortized Gross Gross Fair U.S. Treasury securities $ 106,147 $ — $ (310) $ 105,837 Corporate debt securities 6,449 — (15) 6,434 Total $ 112,596 $ — $ (325) $ 112,271 December 31, 2021 Amortized Gross Gross Fair U.S. Treasury securities $ 81,184 $ — $ (52) $ 81,132 Government-sponsored enterprises 7,739 — (5) 7,734 Corporate debt securities 31,285 — (4) 31,281 Total $ 120,208 $ — $ (61) $ 120,147 All available-for-sale marketable debt securities held as of June 30, 2022 and December 31, 2021 had contractual maturities of less than one year. All of the Company's available-for-sale marketable debt securities in an unrealized loss position as of June 30, 2022 and December 31, 2021 were in a loss position for less than twelve months. Unrealized losses on available-for-sale debt securities as of June 30, 2022 and December 31, 2021 were not significant and were primarily due to changes in interest rates, including market credit spreads, and not due to increased credit risks associated with specific securities. Accordingly, no allowance for credit losses related to the Company's available-for-sale debt securities was recorded |
Inventory, Net
Inventory, Net | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory, Net | Inventory, Net All of the Company's inventory relates to the manufacturing of MARGENZA. The following table sets forth the Company's net inventory (in thousands): June 30, 2022 December 31, 2021 Work in process $ 2,231 $ 3,929 Finished goods 718 459 Total inventory, net $ 2,949 $ 4,388 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity In November 2020, the Company entered into a sales agreement (Sales Agreement) with an agent to sell, from time to time, shares of its common stock having an aggregate sales price of up to $100.0 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 were sold under the Sales Agreement were issued and sold pursuant to the Company's shelf registration statement on Form S-3 that was filed with the SEC on November 4, 2020. During the six months ended June 30, 2021, the Company sold 3,622,186 shares of common stock at a weighted average price per share of $27.60, resulting in net proceeds of approximately $98.2 million, net of underwriting discounts and commissions and other offering expenses. In April 2021, the Company entered into Amendment No. 1 to the Sales Agreement which increases the amount of the Company’s common stock that can be sold by the Company through its agent under the ATM Offering, from an aggregate offering price of up to $100.0 million to an aggregate offering price of up to $300.0 million. The Company has not sold any shares of common stock related to Amendment No. 1 to the Sales Agreement as of June 30, 2022. As part of the consideration for the rights granted to Zai Lab US LLC under the collaboration and license agreement described more fully in Note 7, Revenue, the Company and Zai Lab US LLC entered into a separate stock purchase agreement (Stock Purchase Agreement) in June 2021. Under this Stock Purchase Agreement, Zai Lab US LLC paid the Company approximately $30.0 million to purchase 958,467 newly issued shares of the Company's common stock, par value $0.01, at a fixed price of $31.30 which represented a $10.4 million premium over the share price on the Stock Purchase Agreement date. |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2022 | |
Collaboration and License Agreements [Abstract] | |
Revenue | Revenue Collaborative and Other Agreements Incyte Corporation Incyte License Agreement In 2017, the Company entered into an exclusive global collaboration and license agreement with Incyte Corporation (Incyte) for retifanlimab, 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 retifanlimab in all indications, while the Company retains the right to develop its pipeline assets in combination with retifanlimab. Under the terms of the Incyte License Agreement, Incyte paid the Company an upfront payment of $150.0 million in 2017. In July 2021, Incyte announced that the FDA had issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal. Incyte’s announcement indicated that the FDA determined that additional data are needed to demonstrate the clinical benefit of retifanlimab for the submitted indication, and that Incyte was reviewing the CRL and would discuss next steps with the FDA. Incyte subsequently withdrew its European application for marketing authorization of retifanlimab for the treatment of squamous carcinoma of the anal canal. Incyte has stated it is pursuing development of retifanlimab in potentially registration-enabling studies beyond squamous cell carcinoma of the anal canal, including in patients with MSI-high endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer. Incyte is also pursuing development of retifanlimab in combination with multiple product candidates from its pipeline. In April 2022, the Company and Incyte executed an amendment to the Incyte License Agreement to add a milestone for U.S. approval of retifanlimab in a specific indication and to exclude certain other regulatory and development achievements with retifanlimab in this same indication from the milestone events of the Incyte License Agreement. Under the terms of the Incyte License Agreement, as amended, Incyte will lead global development of retifanlimab. Assuming successful development and commercialization by Incyte, the Company could receive up to $435.0 million in development and regulatory milestones and up to $330.0 million in commercial milestones. From the inception of the Incyte License Agreement through June 30, 2022 , the Company has recognized $70.0 million in development milestones under the Incyte License Agreement. In July 2022, the Company and Incyte further amended the Incyte License Agreement to reflect changes related to the payment of certain milestones and the Company received $30.0 million in milestone payments from Incyte. If retifanlimab is approved and 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 retifanlimab, with Incyte commercializing retifanlimab 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 retifanlimab, subject to the separate commercial supply agreement. The Company evaluated the Incyte License Agreement under the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606) and identified the following two performance obligations under the agreement: (i) the license of retifanlimab 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 License 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 the 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. From 2018 through June 30, 2022 , it became probable that a significant reversal of cumulative revenue would not occur for development milestones totaling $70.0 million related to clinical and regulatory activities related to the further advancement of retifanlimab, including Incyte’s initiation of a Phase 3 clinical trial . Therefore, the associated consideration was added to the estimated transaction price and was recognized as revenue . 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 ratably as services were performed during 2017 and 2018. No revenue was recognized under the Incyte License Agreement during the three and six months ended June 30, 2022. $5.0 million and $15.0 million in milestone revenue was recognized under the Incyte License Agreement during the three and six months ended June 30, 2021, respectively. Incyte Clinical Supply Agreement In 2018, the Company entered into an agreement with Incyte, under which the Company is to perform development and manufacturing services for Incyte’s clinical needs of retifanlimab (Incyte Clinical Supply Agreement). The Company evaluated the Incyte Clinical Supply 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 retifanlimab. 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. The transaction price is being recognized using the input method reflecting the costs incurred (including resources consumed and labor hours expended) related to the manufacturing services. During the three months ended June 30, 2022 and 2021, the Company recognized revenue of $0.2 million and $0.7 million, respectively, for services performed under the Incyte Clinical Supply Agreement. During the six months ended June 30, 2022 and 2021, the Company recognized revenue of $0.5 million and $0.8 million, respectively, for services performed under the Incyte Clinical Supply Agreement. Incyte Commercial Supply Agreement In 2020, the Company entered into an agreement with Incyte pursuant to which the Company is entitled to manufacture a portion of the global commercial supply needs for retifanlimab (Incyte Commercial Supply Agreement). Unless terminated earlier, the term of the Incyte Commercial Supply Agreement will expire upon the expiration of Incyte’s obligation to pay royalties under the Incyte License Agreement. The Company evaluated the Incyte Commercial Supply Agreement under ASC 606 and identified one performance obligation under the agreement: to perform services related to manufacturing the commercial supply of retifanlimab. The transaction price is based on a fixed price per batch of bulk drug substance to be manufactured 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. The transaction price will be recognized using the input method reflecting the costs incurred (including resources consumed and labor costs incurred) related to the manufacturing services. During the three months ended June 30, 2022 and 2021, the Company recognized $0.3 million and $2.8 million, respectively, for services performed under the Incyte Commercial Supply Agreement. During the six months ended June 30, 2022 and 2021, the Company recognized $0.3 million and $5.9 million, respectively, for services performed under the Incyte Commercial Supply Agreement. Zai Lab Limited 2018 Zai Lab Agreement In 2018, the Company entered into a collaboration and license agreement with Zai Lab Limited (Zai Lab) 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) tebotelimab, 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 (2018 Zai Lab Agreement). Zai Lab will lead clinical development of these molecules in its territory. Zai Lab has informed the Company that they have decided to discontinue development of tebotelimab for indications they were enrolling in their territory and is evaluating future development plans in other indications. Under the terms of the 2018 Zai Lab Agreement, Zai Lab paid the Company an upfront payment of $25.0 million ($22.5 million after netting value-added tax withholdings of $2.5 million). Assuming successful development and commercialization of margetuximab, tebotelimab and the TRIDENT molecule, the Company could receive up to $140.0 million in development and regulatory milestones, of which the Company has earned $9.0 million through June 30, 2022. 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 tebotelimab 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 2018 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 tebotelimab: (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 tebotelimab 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 net $22.5 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. From 2020 through June 30, 2022 , it became probable that a significant reversal of cumulative revenue would not occur for development and regulatory milestones totaling $9.0 million. Therefore, the associated consideration was added to the estimated transaction price and was recognized as revenue . Of this $9.0 million , $5.0 million was recognized as revenue during the six months ended June 30, 2022. During the three and six months ended June 30, 2022, the Company recognized $0.4 million and $5.4 million, respectively, under the 2018 Zai Lab Agreement. No revenue was recognized during the three and six months ended June 30, 2021 under the 2018 Zai Lab Agreement. Zai Lab Clinical Supply Agreements During 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 tebotelimab (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 each of margetuximab and tebotelimab. 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. The transaction price is being recognized using the input method reflecting the costs incurred (including resources consumed and labor hours expended) related to the manufacturing service. During the three months ended June 30, 2022 and 2021, the Company recognized revenue of $0.1 million and $0.5 million, respectively, related to the Zai Lab Clinical Supply Agreements. During the six months ended June 30, 2022 and 2021, the Company recognized revenue of $0.3 million and $1.6 million, respectively, related to the Zai Lab Clinical Supply Agreements. 2021 Zai Lab Agreement In June 2021, the Company entered into a collaboration and license agreement with Zai Lab US LLC (collectively with Zai Lab Limited referred herein as Zai Lab) involving collaboration programs and license-only programs (collectively, the Programs) encompassing four separate immuno-oncology molecules (2021 Zai Lab Agreement). The first program covers a lead research molecule that incorporates the Company’s DART platform and binds CD3 and an undisclosed target that is expressed in multiple solid tumors (Lead Program). The second program covers a target to be designated by the Company. For these programs, Zai Lab receives commercial rights in Greater China, Japan, and Korea while the Company receives commercial rights in all other territories. Under the Lead Program, Zai Lab received an option upon reaching a predefined clinical milestone to convert the regional arrangement into a global 50/50 profit share. If Zai Lab elects such option, Zai Lab is to pay the Company $85.0 million plus any research costs incurred by both parties as of the option election date. Zai Lab also obtained exclusive, global licenses from the Company to develop, manufacture and commercialize two additional molecules. Zai Lab granted the Company a worldwide, royalty-free, co-exclusive license to conduct the development activities allocated to the Company. Under the terms of the 2021 Zai Lab Agreement, the Lead Program includes joint research and development services by both the Company and Zai Lab. For the other programs, Zai Lab can separately negotiate and agree with the Company to perform research and development services in the future. In connection with the execution of the 2021 Zai Lab Agreement, Zai Lab paid the Company an upfront payment of $25.0 million. Additionally, as part of the consideration for the rights granted to Zai Lab under the 2021 Zai Lab Agreement, the Company and Zai Lab entered into the Stock Purchase Agreement whereby Zai Lab paid the Company approximately $30.0 million to purchase shares of the Company’s common stock, par value $0.01, at a fixed price of $31.30 which represented a $10.4 million premium over the share price on the Stock Purchase Agreement date. Assuming successful development and commercialization of the Programs, the Company could receive up to approximately $800.0 million in development and regulatory milestones and $600.0 million in commercial milestones. In addition, Zai Lab would pay the Company tiered royalties at percentage rates of low double digit teens on annual net sales of certain specified products and of mid-single digits to low double digit teens on annual net sales of other specified products in Zai Lab’s territory, which may be subject to specified royalty reduction pursuant to the 2021 Zai Lab Agreement. Per the terms of the 2021 Zai Lab Agreement, the Company may also receive reimbursements from Zai Lab for certain research and development costs incurred by the Company. The Company evaluated the 2021 Zai Lab Agreement under the provisions of ASC 606 and identified the following material promises: (i) exclusive licenses to develop, manufacture and commercialize the products in Zai Lab’s territory for each Program and (ii) certain research and development activities for the Lead Program. The Company determined that for the Lead Program, the license is not distinct from the related research and development activities, considering the early stage of development of the molecule and the Company’s significant expertise in this area and as such, the research and development services are expected to significantly modify and customize the license. Therefore, for the Lead Program, the license and the services were combined into a single performance obligation. Since the other programs each represent distinct intellectual property and there are no other services included in the 2021 Zai Lab Agreement related to these licenses, each license is considered to be a distinct performance obligation. As such, there are four performance obligations included in the 2021 Zai Lab Agreement. The Company concluded that the estimated transaction price is $40.4 million, consisting of the $25.0 million upfront payment, the $10.4 million premium related to the purchase of the Company’s common stock, and the $5.0 million estimated reimbursement by Zai Lab for research and development activities for the Lead Program. The potential milestone payments were deemed to be 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 will re-assess the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. The transaction price of $40.4 million was then allocated to the four performance obligations based on their relative standalone selling price. The standalone selling price of the performance obligations was not directly observable; therefore, the Company estimated the standalone selling price using an adjusted market assessment approach, representing the amount that the Company believes a market participant is willing to pay for the product or service. The estimate was based on consideration of observable inputs, such as, values of other preclinical collaboration arrangements adjusted for the Company’s estimate of the probability of success for each Program. Revenue related to the Lead Program license and related research and development services performance obligation is being recognized over time as the research and development activities are performed. The Company will utilize 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. The Company recognized revenue allocated to the other programs at a point in time upon transfer of the licenses to Zai Lab in June 2021. During the three months ended June 30, 2022 and 2021, the Company recognized revenue of $14.7 million and $14.4 million, respectively, under the 2021 Zai Lab Agreement. During the six months ended June 30, 2022 and 2021, the Company recognized revenue of $15.0 million and $14.4 million, respectively, under the 2021 Zai Lab Agreement. As of June 30, 2022, $1.8 million in revenue was deferred under the agreement, all of which was current. As of December 31, 2021, $16.1 million in revenue was deferred, all of which was current. Janssen Biotech, Inc. In December 2020, the Company entered into a research collaboration and license agreement with Janssen Biotech, Inc. (Janssen) to develop a novel DART molecule (Janssen Agreement). The research collaboration will incorporate the Company’s proprietary DART platform to enable simultaneous targeting of two undisclosed targets in a therapeutic area outside oncology. Under the terms of the Janssen Agreement, Janssen paid the Company an upfront payment of $20.0 million and will be responsible for funding all research and development expenses. The Company will also be eligible to receive up to $312.0 million in potential milestone payments and tiered royalties of up to 10% on worldwide product sales. Subject to the terms of this agreement, the Company granted Janssen an exclusive, royalty-bearing license to develop, manufacture and commercialize the preclinical bispecific molecule and the Company will perform certain research and development activities during a specified research term. The Company evaluated the Janssen Agreement under the provisions of ASC 606 and identified the following material promises under the arrangement: (i) a license to develop the preclinical bispecific molecule and (ii) performing certain research and development activities during the research term. The Company determined that the license and research and development 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 Janssen could benefit from the license on its own without the Company’s involvement during the research term. The Company determined that the transaction price of the Janssen Agreement at inception was $22.2 million, consisting of the consideration to which the Company was entitled in exchange for the license and an estimate of the consideration for research and development 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 as well as current market conditions. The standalone selling price for agreed-upon research and development activities to be performed was determined using the expected cost approach based on similar arrangements the Company has with other parties. This variable consideration is fully constrained until the Company begins its work under the performance obligation. The potential 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 Janssen 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. The Company recognized the $20.0 million allocated to the license when it satisfied its performance obligation and transferred the license to Janssen in December 2020. The $2.2 million allocated to the research and development activities is being recognized over the Company’s involvement in the research term, which is estimated to be less than two years. During the three months ended June 30, 2022 and 2021, the Company recognized revenue of $0.2 million and $0.6 million, respectively, for research and development activities performed under the Janssen Agreement. During the six months ended June 30, 2022, and 2021 the Company recognized revenue of $0.6 million and $0.9 million, respectively, for research and development activities performed under the Janssen Agreement. I-Mab Biopharma I-Mab License Agreement In 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 License 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 License 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, of which $5.0 million has been earned from the inception of the I-Mab License Agreement through June 30, 2022. In addition, I-Mab would pay the Company tiered royalties ranging from mid-teens to 20% on annual net sales in I-Mab's territory. The Company evaluated the I-Mab License 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 paid the Company for the cost of this study as the costs were incurred and I-Mab received a one-time credit of eighty percent of the total amount of such costs against the milestone achieved during 2021. The Company reassessed the transaction price as it became probable that a significant reversal of cumulative revenue would not occur for a $5.0 million milestone ($4.5 million after netting a one-time credit as described above) related to development progress of enoblituzumab, therefore the associated consideration was added to the estimated transaction price and was recognized as revenue during 2021. 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 License 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 three months ended June 30, 2022 and 2021, the Company recognized revenue of $0.6 million and $1.9 million, respectively, under the I-Mab License Agreement. During the six months ended June 30, 2022 and 2021, the Company recognized revenue of $0.7 million and $2.5 million, respectively, under the I-Mab License Agreement. As of June 30, 2022, $3.8 million in revenue was deferred under the I-Mab License Agreement, all of which was current. As of December 31, 2021, $4.5 million in revenue was deferred under the I-Mab License Agreement, all of which was current. I-Mab Clinical Supply Agreement In October 2021, the Company entered into an agreement under which the Company is to perform development and manufacturing services for I-Mab’s clinical needs of enoblituzumab (I-Mab 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 enoblituzumab. 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. The transaction price will be recognized using the input method reflecting the costs incurred (including resources consumed and labor hours expended) relate |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
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 (IRC), 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 six months ended June 30, 2022, 65,125 shares of common stock were purchased under the 2016 ESPP. Employee Stock Option 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 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 June 30, 2022, under the 2003 Plan, there were options to purchase an aggregate of 105,282 shares of common stock outstanding. 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 number of shares of common stock reserved for issuance under the 2013 Plan 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 Company's Board of Directors. During the six months ended June 30, 2022, the maximum number of shares of common stock authorized to be issued by the Company under the 2013 Plan was increased to 15,816,949. 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 June 30, 2022, there were options to purchase an aggregate of 10,395,473 shares of common stock outstanding. The following stock-based compensation expense was recognized for the periods indicated (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 2,658 $ 3,058 $ 5,050 $ 5,785 Selling, general and administrative 2,642 3,012 5,524 5,571 Total stock-based compensation expense $ 5,300 $ 6,070 $ 10,574 $ 11,356 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 for options issued during the period indicated: Six Months Ended June 30, 2022 2021 Expected dividend yield 0% 0% Expected volatility 87.8% -89.7% 86.2% - 86.7% Risk-free interest rate 1.4% - 3.6% 0.6% - 1.4% Expected term 5.95 years 6.25 years The following table summarizes stock option activity during the six months ended June 30, 2022: Shares Weighted- Weighted-Average Aggregate Outstanding, December 31, 2021 8,373,921 $ 21.47 6.6 Granted 2,685,197 9.50 Exercised (80,721) 1.48 Forfeited (267,563) 16.32 Expired (210,079) 23.08 Outstanding, June 30, 2022 10,500,755 $ 18.66 7.0 $ 80 As of June 30, 2022: Exercisable 5,930,958 $ 22.57 5.4 74 Vested and expected to vest 9,719,165 $ 19.00 6.8 79 The weighted-average grant-date fair value of options granted during the six months ended June 30, 2022 and 2021 was $6.96 and $15.11, respectively. The total intrinsic value of options exercised during the six months ended June 30, 2022 and 2021 was approximately $0.5 million and $1.8 million, respectively. The total cash received for options exercised during the six months ended June 30, 2022 and 2021 was $0.3 million and $4.6 million, respectively. The total fair value of shares vested in the six months ended June 30, 2022 and 2021 was approximately $9.4 million and $8.1 million, respectively. As of June 30, 2022, the total unrecognized compensation expense related to unvested stock options, net of related forfeiture estimates, was approximately $33.9 million, which the Company expects to recognize over a weighted-average period of approximately 1.5 years. Restricted Stock Units The Company grants restricted stock units (RSUs) under the 2013 Plan to employees from time to time as a component of their compensation. During the six months ended June 30, 2022, the Company awarded RSUs to employees in conjunction with the annual performance review process. Each RSU vests over a two-year period and entitles the holder to receive one share of the Company's common stock when the RSU vests. Compensation expense is recognized on a straight-line basis over the vesting period. The following table summarizes RSU activity during the six months ended June 30, 2022: Shares Weighted-Average Grant Date Fair Value Outstanding, December 31, 2021 21,500 $ 25.97 Granted 314,372 10.13 Exercised (8,465) 26.69 Forfeited (20,099) 10.15 Outstanding, June 30, 2022 307,308 10.78 At June 30, 2022, there was $2.4 million of total unrecognized compensation cost related to unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of approximately 1.3 years. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and ContingenciesOn September 13, 2019, a securities class action complaint was filed in the U.S. District Court for the District of Maryland (District Court) 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. On August 17, 2020, the Employees’ Retirement System of the City of Baton Rouge and Parish of East Baton Rouge was appointed as Lead Plaintiff, and on October 16, 2020, the Lead Plaintiff filed an amended complaint. The amended complaint asserts a putative class period stemming from February 6, 2019 to June 4, 2019. The Company filed a Motion to Dismiss on November 30, 2020. On September 29, 2021, the District Court issued an Order dismissing the case, with prejudice. On October 28, 2021 the Lead Plaintiff filed a Notice of Appeal. The appeal is now pending in the Fourth Circuit. 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited interim consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that the management of the Company believes are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There were no new accounting pronouncements that were issued or became effective since the issuance of the Company’s 2021 Annual Report on Form 10-K that had, or are expected to have, a material impact on its consolidated financial position, results of operations or cash flows. |
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. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Financial Assets Measured at Fair Value on a Recurring Basis | Financial assets measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at June 30, 2022 Total Level 1 Level 2 Assets: Money market funds $ 8,162 $ 8,162 $ — U.S. Treasury securities 105,837 105,837 — Corporate debt securities 6,434 — 6,434 Total assets measured at fair value (a) $ 120,433 $ 113,999 $ 6,434 Fair Value Measurements at December 31, 2021 Total Level 1 Level 2 Assets: Money market funds $ 17,202 $ 17,202 $ — U.S. Treasury securities 81,132 81,132 — Government-sponsored enterprises 7,734 — 7,734 Corporate debt securities 37,280 — 37,280 Total assets measured at fair value (b) $ 143,348 $ 98,334 $ 45,014 (a) Total assets measured at fair value at June 30, 2022 includes approximately $8.2 million reported in cash and cash equivalents on the consolidated balance sheet. (b) Total assets measured at fair value at December 31, 2021 includes approximately $23.2 million reported in cash and cash equivalents on the consolidated balance sheet. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-sale Marketable Securities | The following tables summarize the Company's marketable debt securities (in thousands): June 30, 2022 Amortized Gross Gross Fair U.S. Treasury securities $ 106,147 $ — $ (310) $ 105,837 Corporate debt securities 6,449 — (15) 6,434 Total $ 112,596 $ — $ (325) $ 112,271 December 31, 2021 Amortized Gross Gross Fair U.S. Treasury securities $ 81,184 $ — $ (52) $ 81,132 Government-sponsored enterprises 7,739 — (5) 7,734 Corporate debt securities 31,285 — (4) 31,281 Total $ 120,208 $ — $ (61) $ 120,147 |
Inventory, Net (Tables)
Inventory, Net (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | All of the Company's inventory relates to the manufacturing of MARGENZA. The following table sets forth the Company's net inventory (in thousands): June 30, 2022 December 31, 2021 Work in process $ 2,231 $ 3,929 Finished goods 718 459 Total inventory, net $ 2,949 $ 4,388 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation Expense | The following stock-based compensation expense was recognized for the periods indicated (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 2,658 $ 3,058 $ 5,050 $ 5,785 Selling, general and administrative 2,642 3,012 5,524 5,571 Total stock-based compensation expense $ 5,300 $ 6,070 $ 10,574 $ 11,356 |
Valuation Assumptions Using the Black-Scholes Option-Pricing Model | 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 for options issued during the period indicated: Six Months Ended June 30, 2022 2021 Expected dividend yield 0% 0% Expected volatility 87.8% -89.7% 86.2% - 86.7% Risk-free interest rate 1.4% - 3.6% 0.6% - 1.4% Expected term 5.95 years 6.25 years |
Schedule of Stock Options Roll Forward | The following table summarizes stock option activity during the six months ended June 30, 2022: Shares Weighted- Weighted-Average Aggregate Outstanding, December 31, 2021 8,373,921 $ 21.47 6.6 Granted 2,685,197 9.50 Exercised (80,721) 1.48 Forfeited (267,563) 16.32 Expired (210,079) 23.08 Outstanding, June 30, 2022 10,500,755 $ 18.66 7.0 $ 80 As of June 30, 2022: Exercisable 5,930,958 $ 22.57 5.4 74 Vested and expected to vest 9,719,165 $ 19.00 6.8 79 |
Schedule of RSU Activity | The following table summarizes RSU activity during the six months ended June 30, 2022: Shares Weighted-Average Grant Date Fair Value Outstanding, December 31, 2021 21,500 $ 25.97 Granted 314,372 10.13 Exercised (8,465) 26.69 Forfeited (20,099) 10.15 Outstanding, June 30, 2022 307,308 10.78 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Assets: | ||
Securities | $ 112,271 | $ 120,147 |
Fair Value Measurements, Recurring Basis | ||
Assets: | ||
Cash and cash equivalents | 8,200 | 23,200 |
Total assets measured at fair value | 120,433 | 143,348 |
Fair Value Measurements, Recurring Basis | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 113,999 | 98,334 |
Fair Value Measurements, Recurring Basis | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 6,434 | 45,014 |
Fair Value Measurements, Recurring Basis | Money market funds | ||
Assets: | ||
Cash and cash equivalents | 8,162 | 17,202 |
Fair Value Measurements, Recurring Basis | Money market funds | Level 1 | ||
Assets: | ||
Cash and cash equivalents | 8,162 | 17,202 |
Fair Value Measurements, Recurring Basis | Money market funds | Level 2 | ||
Assets: | ||
Cash and cash equivalents | 0 | 0 |
Fair Value Measurements, Recurring Basis | U.S. Treasury securities | ||
Assets: | ||
Securities | 105,837 | 81,132 |
Fair Value Measurements, Recurring Basis | U.S. Treasury securities | Level 1 | ||
Assets: | ||
Securities | 105,837 | 81,132 |
Fair Value Measurements, Recurring Basis | U.S. Treasury securities | Level 2 | ||
Assets: | ||
Securities | 0 | 0 |
Fair Value Measurements, Recurring Basis | Government-sponsored enterprises | ||
Assets: | ||
Securities | 7,734 | |
Fair Value Measurements, Recurring Basis | Government-sponsored enterprises | Level 1 | ||
Assets: | ||
Securities | 0 | |
Fair Value Measurements, Recurring Basis | Government-sponsored enterprises | Level 2 | ||
Assets: | ||
Securities | 7,734 | |
Fair Value Measurements, Recurring Basis | Corporate debt securities | ||
Assets: | ||
Securities | 6,434 | 37,280 |
Fair Value Measurements, Recurring Basis | Corporate debt securities | Level 1 | ||
Assets: | ||
Securities | 0 | 0 |
Fair Value Measurements, Recurring Basis | Corporate debt securities | Level 2 | ||
Assets: | ||
Securities | $ 6,434 | $ 37,280 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 112,596,000 | $ 120,208,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (325,000) | (61,000) |
Fair Value | 112,271,000 | 120,147,000 |
Allowance for credit loss related to available-for-sale debt securities | 0 | 0 |
U.S. Treasury securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 106,147,000 | 81,184,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (310,000) | (52,000) |
Fair Value | 105,837,000 | 81,132,000 |
Government-sponsored enterprises | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 7,739,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (5,000) | |
Fair Value | 7,734,000 | |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 6,449,000 | 31,285,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (15,000) | (4,000) |
Fair Value | $ 6,434,000 | $ 31,281,000 |
Inventory, Net (Details)
Inventory, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Work in process | $ 2,231 | $ 3,929 |
Finished goods | 718 | 459 |
Total inventory, net | 2,949 | 4,388 |
Inventory valuation reserves | $ 3,100 | $ 2,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | ||||
Jun. 30, 2021 | Apr. 30, 2021 | Nov. 30, 2020 | Dec. 31, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | |
Class of Stock [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Number of shares issued or sold (in shares) | 958,467 | 3,622,186 | ||||
At the Market Offering | ||||||
Class of Stock [Line Items] | ||||||
Maximum amount available for issuance | $ 100 | |||||
Number of shares sold (in shares) | 3,622,186 | |||||
Sales of stock purchase price (in dollars per share) | $ 27.6 | |||||
Proceeds of stock sale | $ 98.2 | |||||
Maximum amount available for issuance, increase | $ 300 |
Collaboration and Other Agreeme
Collaboration and Other Agreements - Incyte Corporation (Details) | 3 Months Ended | 6 Months Ended | 7 Months Ended | 9 Months Ended | 24 Months Ended | 54 Months Ended | |||||||
Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jul. 31, 2022 USD ($) | Sep. 30, 2020 USD ($) | Sep. 30, 2018 USD ($) | Dec. 31, 2018 USD ($) performanceObligation | Jun. 30, 2022 USD ($) | Jul. 01, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenues | $ 26,007,000 | $ 30,757,000 | $ 37,108,000 | $ 47,638,000 | |||||||||
Deferred revenue, current | 11,565,000 | 11,565,000 | $ 11,565,000 | $ 20,646,000 | |||||||||
Deferred revenue, net of current portion | 6,163,000 | 6,163,000 | 6,163,000 | 0 | |||||||||
Incyte Corporation | Incyte MGA012 Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Non-refundable upfront payment | $ 150,000,000 | ||||||||||||
Potential development and regulatory milestone payments under agreement | $ 435,000,000 | ||||||||||||
Potential commercial milestone payments under agreement | $ 330,000,000 | ||||||||||||
Development and regulatory milestones recognized | 15,000,000 | 70,000,000 | |||||||||||
Number of performance obligations | performanceObligation | 2 | ||||||||||||
Collaborative agreement transaction price | $ 154,000,000 | ||||||||||||
Variable consideration recognized | $ 4,000,000 | ||||||||||||
Incyte Corporation | Incyte MGA012 Agreement | Subsequent Event | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Two Additional Incyte License Agreement Milestone | $ 30,000,000 | ||||||||||||
I-Mab | I-Mab Biopharma Collaboration and License Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Non-refundable upfront payment | $ 15,000,000 | ||||||||||||
Potential development and regulatory milestone payments under agreement | $ 135,000,000 | ||||||||||||
Development and regulatory milestones recognized | $ 5,000,000 | 5,000,000 | |||||||||||
Revenues | 600,000 | 1,900,000 | 700,000 | 2,500,000 | |||||||||
Deferred revenue | 3,800,000 | 3,800,000 | 3,800,000 | $ 4,500,000 | |||||||||
Minimum | Incyte Corporation | Incyte MGA012 Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Potential proceeds from royalties (percent) | 15% | ||||||||||||
Maximum | Incyte Corporation | Incyte MGA012 Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Potential proceeds from royalties (percent) | 24% | ||||||||||||
Maximum | I-Mab | I-Mab Biopharma Collaboration and License Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Potential proceeds from royalties (percent) | 20% | ||||||||||||
Revenues From License Agreements | Incyte Corporation | Incyte MGA012 Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenues | $ 150,000,000 | ||||||||||||
Revenues From License Agreements | Incyte Corporation | Incyte MGA012 Agreement - Clinical activities | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenues | 0 | 5,000,000 | 0 | ||||||||||
Revenues From License Agreements | Incyte Corporation | Incyte MGA012 Clinical Services | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenues | 200,000 | 700,000 | 500,000 | 800,000 | |||||||||
Revenues From License Agreements | Incyte Corporation | Incyte MGA012 Supply Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenues | 300,000 | $ 2,800,000 | 300,000 | $ 5,900,000 | |||||||||
RevenuesFromCMOAgreementsMember | Incyte Corporation | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenues | 4,000,000 | ||||||||||||
Deferred revenue | 9,500,000 | 9,500,000 | 9,500,000 | ||||||||||
Deferred revenue, current | 3,300,000 | 3,300,000 | 3,300,000 | ||||||||||
Deferred revenue, net of current portion | 6,200,000 | 6,200,000 | 6,200,000 | ||||||||||
Annual Fixed Payments | $ 14,400,000 | $ 14,400,000 | $ 14,400,000 | ||||||||||
RevenuesFromCMOAgreementsMember | Incyte Corporation | Subsequent Event | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Non-refundable upfront payment | $ 10,000,000 |
Collaboration and Other Agree_2
Collaboration and Other Agreements - Zai Lab (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | 24 Months Ended | |||||
Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2018 | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 15, 2021 | Dec. 31, 2020 | |
Collaboration And Other Agreements [Line Items] | ||||||||||
Revenues | $ 26,007 | $ 30,757 | $ 37,108 | $ 47,638 | ||||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||
Deferred revenue, current | $ 11,565 | $ 11,565 | $ 11,565 | $ 20,646 | ||||||
Deferred revenue, net of current portion | 6,163 | 6,163 | 6,163 | 0 | ||||||
2018 Zai Lab Agreement | Zai Labs | ||||||||||
Collaboration And Other Agreements [Line Items] | ||||||||||
Non-refundable upfront payment | $ 25,000 | |||||||||
Non-refundable upfront payment, net of tax withholding | 22,500 | |||||||||
Nonrefundable payment tax withholding | $ 2,500 | |||||||||
Potential development and regulatory milestone payments under agreement | $ 140,000 | |||||||||
Development and regulatory milestones recognized | 9,000 | |||||||||
Revenues | 400 | 0 | 5,400 | 0 | ||||||
Millstone Revenue Recognized | 5,000 | |||||||||
Zai Lab Agreement, Margetuximab | Zai Labs | Maximum | ||||||||||
Collaboration And Other Agreements [Line Items] | ||||||||||
Potential proceeds from royalties (percent) | 20% | |||||||||
Zai Lab Agreement, TRIDENT molecule | Zai Labs | ||||||||||
Collaboration And Other Agreements [Line Items] | ||||||||||
Potential proceeds from royalties (percent) | 10% | |||||||||
Zai Lab Clinical Supply Agreements | Zai Labs | ||||||||||
Collaboration And Other Agreements [Line Items] | ||||||||||
Revenues | 100 | 500 | 300 | 1,600 | ||||||
2021 Zai Lab Agreements | Zai Labs | ||||||||||
Collaboration And Other Agreements [Line Items] | ||||||||||
Non-refundable upfront payment | $ 25,000 | |||||||||
Potential development and regulatory milestone payments under agreement | $ 800,000 | |||||||||
Deferred revenue | 1,800 | 1,800 | $ 1,800 | $ 16,100 | ||||||
Revenues | $ 14,700 | $ 14,400 | $ 15,000 | $ 14,400 | ||||||
Opt-in fee | $ 85,000 | |||||||||
Proceeds of stock sale | 30,000 | |||||||||
Sales of stock purchase price (in dollars per share) | $ 31.3 | |||||||||
Potential commercial milestone payments under agreement | $ 600,000 | |||||||||
Collaborative agreement transaction price | $ 40,400 | |||||||||
Variable consideration recognized | 5,000 | |||||||||
2021 Zai Lab Agreements | Zai Labs | Additional Paid-In Capital | ||||||||||
Collaboration And Other Agreements [Line Items] | ||||||||||
Premium received on stock purchase | $ 10,400 |
Collaboration and Other Agree_3
Collaboration and Other Agreements - Janssen (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Dec. 31, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Collaboration And Other Agreements [Line Items] | ||||||
Revenues | $ 26,007 | $ 30,757 | $ 37,108 | $ 47,638 | ||
Janssen Biotech Inc | Janssen Collaboration and License Agreement | ||||||
Collaboration And Other Agreements [Line Items] | ||||||
Non-refundable upfront payment | $ 20,000 | |||||
Potential milestone payments and royalties on product sales | $ 312,000 | |||||
Potential proceeds from royalties (percent) | 10% | |||||
Collaborative agreement transaction price | $ 22,200 | |||||
Clinical trial activities selling price amount | $ 2,200 | |||||
Janssen Biotech Inc | Janssen Collaboration and License Agreement | Revenues From License Agreements | ||||||
Collaboration And Other Agreements [Line Items] | ||||||
Revenues | $ 20,000 | |||||
Janssen Biotech Inc | Janssen Collaboration and License Agreement | Revenue From Performance of the Research and Development Activities | ||||||
Collaboration And Other Agreements [Line Items] | ||||||
Revenues | $ 200 | $ 600 | $ 600 | $ 900 |
Collaboration and Other Agree_4
Collaboration and Other Agreements - I-Mab Biopharma (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | |||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaboration And Other Agreements [Line Items] | ||||||||
Revenues | $ 26,007 | $ 30,757 | $ 37,108 | $ 47,638 | ||||
Deferred revenue, current | 11,565 | 11,565 | $ 20,646 | |||||
Deferred revenue, net of current portion | 6,163 | 6,163 | 0 | |||||
I-Mab | I-Mab Biopharma Collaboration and License Agreement | ||||||||
Collaboration And Other Agreements [Line Items] | ||||||||
Non-refundable upfront payment | $ 15,000 | |||||||
Potential development and regulatory milestone payments under agreement | $ 135,000 | |||||||
Development and regulatory milestones recognized | $ 5,000 | 5,000 | ||||||
Estimated variable consideration | $ 1,000 | |||||||
Revenues | 600 | $ 1,900 | 700 | $ 2,500 | ||||
Deferred revenue | 3,800 | 3,800 | 4,500 | |||||
One Time Millstone Credit | $ 4,500 | |||||||
I-Mab | I-Mab Biopharma Collaboration and License Agreement | Maximum | ||||||||
Collaboration And Other Agreements [Line Items] | ||||||||
Potential proceeds from royalties (percent) | 20% | |||||||
I-Mab | I-Mab Biopharma Collaboration And License Agreement Clinical Supply | ||||||||
Collaboration And Other Agreements [Line Items] | ||||||||
Revenues | $ 300 | $ 1,100 |
Collaboration and Other Agree_5
Collaboration and Other Agreements - NIAID Contract (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Sep. 15, 2015 Molecule | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | |
Collaboration And Other Agreements [Line Items] | |||||
Revenues | $ 26,007 | $ 30,757 | $ 37,108 | $ 47,638 | |
NIAID | |||||
Collaboration And Other Agreements [Line Items] | |||||
Number of commercialized molecules | Molecule | 2 | ||||
Total potential value | 25,100 | ||||
Revenues From Grants | NIAID | |||||
Collaboration And Other Agreements [Line Items] | |||||
Revenues | $ 500 | $ 400 | $ 900 | $ 1,200 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
May 31, 2017 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Oct. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Offering period | 6 months | ||||||
Options outstanding (in shares) | 10,500,755 | 10,500,755 | 8,373,921 | ||||
Weighted-average exercise price of stock options outstanding (in dollars per share) | $ 18.66 | $ 18.66 | $ 21.47 | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Stock-based compensation expense | $ 5,300 | $ 6,070 | $ 10,574 | $ 11,356 | |||
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 | ||||||
Payroll deduction percentage | 10% | ||||||
Purchase price of common stock percent of the fair market value | 85% | ||||||
Common stock purchased (in shares) | 65,125 | ||||||
2003 Stock Incentive Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Options outstanding (in shares) | 105,282 | 105,282 | |||||
Stock Incentive Plan 2013 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based compensation, number of shares authorized (in shares) | 15,816,949 | 15,816,949 | |||||
Options outstanding (in shares) | 10,395,473 | 10,395,473 | |||||
Potential annual increase in shares reserved for future issuance (in shares) | 1,960,168 | ||||||
Potential annual increase in shares reserved for future issuance as percentage of outstanding share | 4% | ||||||
Research and Development | |||||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Stock-based compensation expense | $ 2,658 | 3,058 | $ 5,050 | 5,785 | |||
General and Administrative | |||||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Stock-based compensation expense | $ 2,642 | $ 3,012 | $ 5,524 | $ 5,571 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option Pricing Assumptions (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Expected term (in years) | 5 years 11 months 12 days | 6 years 3 months |
Weighted- Average Exercise Price, Expired (in dollars per share) | $ 23.08 | |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 87.80% | 86.20% |
Risk-free interest rate | 1.40% | 0.60% |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 89.70% | 86.70% |
Risk-free interest rate | 3.60% | 1.40% |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 9 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | Sep. 30, 2021 | |
Shares | |||
Shares, Outstanding, Beginning Balance (in shares) | 8,373,921 | ||
Shares, Granted (in shares) | 2,685,197 | ||
Shares, Exercised (in shares) | (80,721) | ||
Shares, Forfeited or expired (in shares) | (267,563) | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period | (210,079) | ||
Shares, Outstanding, Ending Balance (in shares) | 10,500,755 | ||
Shares, Exercisable (in shares) | 5,930,958 | ||
Shares, Vested and expected to vest (in shares) | 9,719,165 | ||
Weighted- Average Exercise Price | |||
Weighted- Average Exercise Price, Outstanding, Beginning Balance (in dollars per share) | $ 21.47 | ||
Weighted- Average Exercise Price, Granted (in dollars per share) | 9.50 | ||
Weighted- Average Exercise Price, Exercised (in dollars per share) | 1.48 | ||
Weighted- Average Exercise Price, Forfeited (in dollars per share) | 16.32 | ||
Weighted- Average Exercise Price, Expired (in dollars per share) | 23.08 | ||
Weighted- Average Exercise Price, Outstanding, Ending Balance (in dollars per share) | 18.66 | ||
Weighted- Average Exercise Price, Exercisable (in dollars per share) | 22.57 | ||
Weighted- Average Exercise Price, Vested and expected to vest (in dollars per share) | $ 19 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Weighted- Average Remaining Contractual Term, Outstanding (in years) | 7 years | 6 years 7 months 6 days | |
Weighted- Average Remaining Contractual Term, Exercisable (in years) | 5 years 4 months 24 days | ||
Weighted- Average Remaining Contractual Term, Vested and expected to vest (in years) | 6 years 9 months 18 days | ||
Aggregate Intrinsic Value, Outstanding, Ending Balance | $ 80 | ||
Aggregate Intrinsic Value, Exercisable | 74 | ||
Aggregate Intrinsic Value, Vested and expected to vest | $ 79 | ||
Weighted-average grant-date fair value of options granted (in dollars per share) | $ 6.96 | $ 15.11 | |
Intrinsic value of options exercised | $ 500 | $ 1,800 | |
Cash received for options exercised | 300 | 4,600 | |
Fair value of shares vested | 9,400 | $ 8,100 | |
Unrecognized compensation expense related to non-vested stock-options, net of related forfeiture estimates | $ 33,900 | ||
Unrecognized compensation expense recognition period (in years) | 1 year 6 months |
Stock-based Compensation - Rest
Stock-based Compensation - Restricted Stock Unit Activity (Details) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) shares $ / shares | |
Weighted-Average Grant Date Fair Value | |
Unrecognized compensation expense recognition period (in years) | 1 year 6 months |
Restricted Stock Units | |
Shares | |
Beginning Balance (in shares) | 21,500 |
Granted (in shares) | 314,372 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Exercised | (8,465) |
Exercised (in dollars per share) | $ / shares | $ 26.69 |
Forfeited or expired (in shares) | (20,099) |
Ending Balance (in shares) | 307,308 |
Weighted-Average Grant Date Fair Value | |
Beginning Balance (in dollars per share) | $ / shares | $ 25.97 |
Granted (in dollars per share) | $ / shares | 10.13 |
Forfeited or expired (in dollars per share) | $ / shares | 10.15 |
Ending Balance (in dollars per share) | $ / shares | $ 10.78 |
Award vesting period | 2 years |
Number of shares per employee | 1 |
Total unrecognized compensation cost | $ | $ 2.4 |
Unrecognized compensation expense recognition period (in years) | 1 year 3 months 18 days |