Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 03, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
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 $0.01 per share | |
Trading Symbol | MGNX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 62,029,447 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001125345 | |
Current Fiscal Year End Date | --12-31 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 89,898 | $ 108,884 |
Marketable securities | 166,534 | 45,462 |
Accounts receivable | 25,311 | 56,222 |
Inventory, net | 1,066 | 1,451 |
Prepaid expenses and other current assets | 8,510 | 10,161 |
Total current assets | 291,319 | 222,180 |
Property, equipment and software, net | 22,634 | 29,575 |
Right-of-use asset | 24,632 | 27,335 |
Other non current assets | 1,387 | 1,378 |
Total assets | 339,972 | 280,468 |
Current liabilities: | ||
Accounts payable | 3,303 | 4,899 |
Accrued expenses and other current liabilities | 25,478 | 28,998 |
Deferred revenue | 18,584 | 9,988 |
Lease liabilities | 3,926 | 4,726 |
Total current liabilities | 51,291 | 48,611 |
Deferred revenue, net of current portion | 64,260 | 59,480 |
Lease liabilities, net of current portion | 30,183 | 30,106 |
Other non current liabilities | 258 | 258 |
Total liabilities | 145,992 | 138,455 |
Stockholders' equity: | ||
Common stock, $0.01 par value -- 125,000,000 shares authorized, 62,028,904 and 61,701,467 shares outstanding at September 30, 2023 and December 31, 2022, respectively | 620 | 617 |
Additional paid-in capital | 1,250,074 | 1,235,095 |
Accumulated other comprehensive income (loss) | (34) | (5) |
Accumulated deficit | (1,056,680) | (1,093,694) |
Total stockholders' equity | 193,980 | 142,013 |
Total liabilities and stockholders' equity | $ 339,972 | $ 280,468 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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) | 62,028,904 | 61,701,467 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Revenues | $ 10,397 | $ 41,734 | $ 48,029 | $ 78,842 |
Costs and expenses: | ||||
Cost of product sales | 85 | 3,007 | 456 | 3,235 |
Cost of manufacturing services | 3,274 | 136 | 7,603 | 2,358 |
Research and development | 30,131 | 48,191 | 119,232 | 161,372 |
Selling, general and administrative | 12,409 | 15,355 | 39,628 | 45,277 |
Total costs and expenses | 45,899 | 66,689 | 166,919 | 212,242 |
Loss from operations | (35,502) | (24,955) | (118,890) | (133,401) |
Gain on modification of debt | 50,000 | 0 | 150,930 | 0 |
Interest and other income | 3,056 | 142 | 6,404 | 841 |
Interest expense | 0 | 0 | (1,430) | 0 |
Net loss | 17,554 | (24,813) | 37,014 | (132,560) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on investments | 38 | 213 | (30) | (52) |
Comprehensive income (loss) | $ 17,592 | $ (24,600) | $ 36,984 | $ (132,612) |
Net income (loss) per common share: | ||||
Basic net loss per common share (in usd per share) | $ 0.28 | $ (0.40) | $ 0.60 | $ (2.16) |
Diluted net loss per common share (in usd per share) | $ 0.28 | $ (0.40) | $ 0.60 | $ (2.16) |
Weighted average common shares outstanding: | ||||
Basic weighted average common shares outstanding (in shares) | 61,980,680 | 61,459,831 | 61,890,824 | 61,390,143 |
Diluted weighted average common shares outstanding (in shares) | 62,244,602 | 61,459,831 | 62,090,343 | 61,390,143 |
Collaborative and other agreements | ||||
Revenues: | ||||
Revenues | $ 885 | $ 35,674 | $ 23,593 | $ 59,630 |
Product sales, net | ||||
Revenues: | ||||
Revenues | 4,695 | 4,371 | 13,247 | 12,623 |
Government agreements | ||||
Revenues: | ||||
Revenues | 345 | 547 | 1,094 | 1,455 |
Contract Manufacturing | ||||
Revenues: | ||||
Revenues | 4,462 | 1,142 | 9,664 | 5,134 |
RevenueFromRoyalityAgreementsMember | ||||
Revenues: | ||||
Revenues | $ 10 | $ 0 | $ 431 | $ 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, 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] | |||||
Net loss | (132,560) | ||||
Ending balance (in shares) at Sep. 30, 2022 | 61,462,189 | ||||
Ending balance at Sep. 30, 2022 | 122,958 | $ 615 | 1,228,952 | (1,106,496) | (113) |
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 | |||
Stock plan related activity | 264 | $ 2 | 262 | ||
Shares, Granted (in shares) | 125,716 | ||||
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) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 5,077 | 5,077 | |||
Shares, Granted (in shares) | 3,399 | ||||
Unrealized gain (loss) on investments | 213 | 213 | |||
Net loss | (24,813) | (24,813) | |||
Ending balance (in shares) at Sep. 30, 2022 | 61,462,189 | ||||
Ending balance at Sep. 30, 2022 | 122,958 | $ 615 | 1,228,952 | (1,106,496) | (113) |
Beginning balance (in shares) at Dec. 31, 2022 | 61,701,467 | ||||
Beginning balance at Dec. 31, 2022 | 142,013 | $ 617 | 1,235,095 | (1,093,694) | (5) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 4,788 | 4,788 | |||
Stock plan activity (in shares) | 42,098 | ||||
Stock plan related activity | (154) | (154) | |||
Issuance of common stock, net of offering costs (in shares) | 95,000 | ||||
Issuance of common stock, net of offering costs | 617 | $ 1 | 616 | ||
Unrealized gain (loss) on investments | 13 | 13 | |||
Net loss | (38,009) | (38,009) | |||
Ending balance (in shares) at Mar. 31, 2023 | 61,838,565 | ||||
Ending balance at Mar. 31, 2023 | 109,268 | $ 618 | 1,240,345 | (1,131,703) | 8 |
Beginning balance (in shares) at Dec. 31, 2022 | 61,701,467 | ||||
Beginning balance at Dec. 31, 2022 | $ 142,013 | $ 617 | 1,235,095 | (1,093,694) | (5) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Shares, Granted (in shares) | 3,267,727 | ||||
Net loss | $ 37,014 | ||||
Ending balance (in shares) at Sep. 30, 2023 | 62,028,904 | ||||
Ending balance at Sep. 30, 2023 | 193,980 | $ 620 | 1,250,074 | (1,056,680) | (34) |
Beginning balance (in shares) at Mar. 31, 2023 | 61,838,565 | ||||
Beginning balance at Mar. 31, 2023 | 109,268 | $ 618 | 1,240,345 | (1,131,703) | 8 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 4,436 | 4,436 | |||
Stock plan related activity | 216 | $ 1 | 215 | ||
Shares, Granted (in shares) | 63,793 | ||||
Issuance of common stock, net of offering costs (in shares) | 36,135 | ||||
Issuance of common stock, net of offering costs | 235 | 235 | |||
Unrealized gain (loss) on investments | (80) | (80) | |||
Net loss | 57,469 | 57,469 | |||
Ending balance (in shares) at Jun. 30, 2023 | 61,938,493 | ||||
Ending balance at Jun. 30, 2023 | 171,544 | $ 619 | 1,245,231 | (1,074,234) | (72) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 4,746 | 4,746 | |||
Stock plan related activity | (89) | $ 1 | |||
Shares, Granted (in shares) | 54,276 | ||||
Stock plan related activity | (90) | ||||
Issuance of common stock, net of offering costs (in shares) | 36,135 | ||||
Issuance of common stock, net of offering costs | 187 | 187 | |||
Unrealized gain (loss) on investments | 38 | 38 | |||
Net loss | 17,554 | 17,554 | |||
Ending balance (in shares) at Sep. 30, 2023 | 62,028,904 | ||||
Ending balance at Sep. 30, 2023 | $ 193,980 | $ 620 | $ 1,250,074 | $ (1,056,680) | $ (34) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities | ||
Net income (loss) | $ 37,014 | $ (132,560) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization expense | 7,745 | 8,634 |
Amortization of premiums and discounts on marketable securities | (3,276) | 740 |
Stock-based compensation | 14,014 | 15,697 |
Gain on modification of debt | (150,930) | 0 |
Non-cash interest expense recognized | 1,430 | 0 |
Operating Lease, Noncash Expense | 2,703 | 2,468 |
Other non-cash items | 423 | 2,882 |
Loss on disposal of assets | 111 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 30,911 | (3,452) |
Inventory | 385 | 419 |
Prepaid expenses and other current assets | 1,651 | 11,898 |
Other non current assets | (7) | 0 |
Accounts payable | (1,607) | (10,897) |
Accrued expenses and other current liabilities | (3,388) | (184) |
Lease liabilities | (723) | (3,447) |
Deferred revenue | 13,376 | (8,477) |
Net cash used in operating activities | (50,168) | (116,279) |
Cash flows from investing activities | ||
Purchases of marketable securities | (217,216) | (75,457) |
Proceeds from sale and maturities of marketable securities | 99,390 | 155,190 |
Purchases of property, equipment and software | (1,144) | (3,230) |
Proceeds from Sale of Machinery and Equipment | 64 | 0 |
Net cash provided by (used in) investing activities | (118,906) | 76,503 |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of offering costs | 616 | 0 |
Proceeds from stock option exercises and ESPP purchases | 279 | 314 |
Taxes paid related to net share settlement of equity awards | (306) | (14) |
Principal payments on royalty monetization arrangement | (156) | 0 |
Net proceeds from sale of future royalties | 149,655 | 0 |
Net cash provided by financing activities | 150,088 | 300 |
Net change in cash and cash equivalents | (18,986) | (39,476) |
Cash and cash equivalents at beginning of period | 108,884 | 123,469 |
Cash and cash equivalents at end of period | 89,898 | 83,993 |
Supplemental Cash Flow Information | ||
Property, equipment and software included in accounts payable or accruals | $ 166 | $ 295 |
Nature of Operations
Nature of Operations | 9 Months Ended |
Sep. 30, 2023 | |
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, manufacturing 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 MacroGenics or its collaborators. These product candidates include multiple 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. To date, three products originating from our pipeline of proprietary or partnered product candidates have received U.S. Food and Drug Administration (FDA) approval. 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. In November 2022, the FDA approved TZIELD ® (teplizumab-mzwv) to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D. Teplizumab was acquired from the Company by Provention Bio, Inc. (Provention) in May 2018, pursuant to an asset purchase agreement. In March 2023, the FDA approved ZYNYZ™ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1). Retifanlimab was previously developed by the Company and licensed to Incyte Corporation (Incyte) pursuant to an exclusive global collaboration and license agreement in October 2017. 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 and revenue from its multiple collaboration agreements. 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, product sales and royalties. 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. 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, geopolitical tensions and related global slowdown of economic activity, decades-high inflation, rising interest rates, adverse events involving financial institutions or the financial services industry 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. The accompanying unaudited interim consolidated financial statements include the accounts of MacroGenics, Inc. and its wholly owned subsidiaries, MacroGenics UK Limited and MacroGenics Limited. All intercompany accounts and transactions have been eliminated in consolidation. These consolidated financial statements and related notes should be read in conjunction with the financial statements and notes thereto included in the Company's 2022 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 15, 2023. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies During the nine months ended September 30, 2023, the Company adopted the following significant accounting policies in addition to those disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Liability related to the sale of future royalties and related interest expense The Company assesses the relevant accounting criteria under Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 470, Debt (ASC 470) to determine whether the upfront payment received from the purchaser should be accounted for as debt or deferred income depending on the facts and circumstances. If the criteria in ASC 470 is met, the Company accounts for net proceeds from sales of its rights to receive future royalty payments as a liability that is amortized using the effective interest method over the term of the arrangement. The liability related to future royalties is presented net of unamortized issuance costs on the consolidated balance sheets. Interest expense on the liability related to future royalties is recognized using the effective interest rate method over the life of the arrangement. The Company calculates an effective interest rate which will amortize its related obligation to zero over the anticipated repayment period. The liability related to future royalties and the related interest expense are based on the Company’s current estimates of future royalties expected to be received over the life of the arrangement, which the Company determines by using internal sales projections and external information from market data sources, which are considered Level 3 inputs. The Company periodically assesses the expected payments and to the extent the Company’s estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. Non-cash amortization is reflected as interest expense in the consolidated statements of operations and comprehensive income (loss). Upon changes in facts and circumstances, for example as a result of a modification to the existing agreements, the Company re-evaluates its rights and obligations and accounts for the change in accordance with the respective accounting guidance. Recent Accounting Pronouncements There were no new accounting pronouncements that were issued or became effective since the issuance of the Company’s 2022 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 | 9 Months Ended |
Sep. 30, 2023 | |
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 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 September 30, 2023 Total Level 1 Level 2 Assets: Money market funds $ 51,137 $ 51,137 $ — U.S. Treasury securities 26,038 26,038 — Government-sponsored enterprises 83,695 — 83,695 Corporate debt securities 56,801 — 56,801 Total assets measured at fair value (a) $ 217,671 $ 77,175 $ 140,496 Fair Value Measurements at December 31, 2022 Total Level 1 Level 2 Assets: Money market funds $ 41,564 $ 41,564 $ — Government-sponsored enterprises 32,811 — 32,811 Corporate debt securities 17,626 — 17,626 Total assets measured at fair value (b) $ 92,001 $ 41,564 $ 50,437 (a) Total assets measured at fair value at September 30, 2023 includes approximately $51.1 million reported in cash and cash equivalents on the consolidated balance sheet. (b) Total assets measured at fair value at December 31, 2022 includes approximately $46.5 million reported in cash and cash equivalents on the consolidated balance sheet. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities The following tables summarize the Company's marketable debt securities (in thousands): September 30, 2023 Amortized Gross Gross Fair U.S. Treasury securities $ 26,050 $ — $ (12) $ 26,038 Government-sponsored enterprises 83,671 40 (16) 83,695 Corporate debt securities 56,847 — (46) 56,801 Total $ 166,568 $ 40 $ (74) $ 166,534 December 31, 2022 Amortized Gross Gross Fair Government-sponsored enterprises $ 32,812 $ 5 $ (7) $ 32,810 Corporate debt securities 12,655 1 (4) 12,652 Total $ 45,467 $ 6 $ (11) $ 45,462 |
Inventory, Net
Inventory, Net | 9 Months Ended |
Sep. 30, 2023 | |
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): September 30, 2023 December 31, 2022 Work in process $ — $ 409 Finished goods 1,066 1,042 Total inventory, net $ 1,066 $ 1,451 |
Royalty Monetization Arrangemen
Royalty Monetization Arrangement | 9 Months Ended |
Sep. 30, 2023 | |
Liability related to future royalties [Abstract] | |
Royalty Monetization Arrangement | Royalty Monetization ArrangementIn March 2023, the Company entered into a Purchase and Sale Agreement (Royalty Purchase Agreement) with DRI Healthcare Acquisitions LP (DRI), a wholly owned subsidiary of DRI Healthcare Trust, for the sale to DRI of the Company’s single-digit royalty interest on global net sales of TZIELD (teplizumab-mzwv) under the Company’s Asset Purchase Agreement dated May 7, 2018, as amended (the Provention APA), with Provention. The Company retained its other economic interests related to TZIELD under the Provention APA, including future potential development, regulatory, and commercial milestones. Under the terms of the Royalty Purchase Agreement, the Company received $100.0 million from DRI for its single-digit royalty interest on global net sales of TZIELD under the Provention APA (the Royalty Interest). Additionally, the Company has the right to receive a 50% share of the royalty on global net sales above a certain annual threshold (the Retained Interest). In addition, the Company was eligible to receive up to $50.0 million upon the occurrence of pre-specified events tied to the advancement of TZIELD for the treatment of newly diagnosed type 1 diabetes. This milestone was achieved in July 2023 as described below. The Company is also eligible to receive an additional $50.0 million milestone if TZIELD achieves a certain level of net sales (Sales Milestone Payment). The $100.0 million proceeds received from DRI for the Royalty Interest were recorded as a liability related to future royalties, net of transaction costs of $0.3 million, which was to be amortized over the term of the arrangement using the effective interest rate method. At inception, the Company accounted for the Royalty Purchase Agreement as a financing arrangement because the Company had significant continuing involvement in the delivery of future royalty payments to DRI and other existing obligations under the Provention APA. In April 2023, the Company entered into an agreement (the Tripartite Agreement) with DRI and a subsidiary of Sanofi S.A. (Sanofi), whereby the Company consented to the sale of DRI’s Royalty Interest and related milestone payment obligations to Sanofi. The Tripartite Agreement eliminated the Company’s obligation to deliver payments to DRI related to the Royalty Interest and removed all of the Company’s other obligations under the Royalty Purchase Agreement. The Royalty Interest will be paid directly to Sanofi by Provention. As a result, the Company’s royalty rights are only for the Retained Interest. This change in rights and obligations resulted in a change in the terms of the liability related to future royalties which was evaluated by the Company in accordance with ASC 470-50, Debt — Modifications and Extinguishments . The Company concluded that the execution of the Tripartite Agreement resulted in a modification to the liability related to future royalties. The Company determined that the terms of the new liability related to the single-digit future royalties and the original liability related to future royalties were substantially different as the Company no longer receives payments for the Royalty Interest and therefore has a significantly reduced liability to make payments in accordance with the Royalty Purchase Agreement. The new liability related to future royalties was determined to be de minimis. As a result, the Company recorded $100.9 million within other income on the statement of operations and comprehensive income (loss) during the three months ended June 30, 2023. There was no modification to the Company's Retained Interest in the Tripartite Agreement. In July 2023, Sanofi reported achievement of the primary endpoint milestone event related to the $50.0 million milestone noted above. Given that the Company has no continuing obligation to pay the Royalty Interest to Sanofi, the Company recorded this milestone within other income on the statement of operations and comprehensive income (loss) during the three months ended September 30, 2023. Also in September 2023, the Company and Sanofi executed Amendment No. 2 to the Provention APA to incorporate the Sales Milestone Payment obligation from the Royalty Purchase Agreement into the Provention APA. In addition, the Company and Sanofi terminated the Royalty Purchase Agreement, which did not result in a material impact to the financial statements given the fair value of the liability related to future royalties was de minimis. Changes to the liability related to future royalties were as follows for the nine months ended September 30, 2023 (in thousands): Liability related to future royalties - beginning balance $ — Proceeds from sale of future royalties 150,000 Deferred transaction costs (344) Royalty revenue payable to DRI (156) Interest expense recognized 1,430 Gain on royalty monetization arrangement (150,930) Liability related to future royalties - ending balance $ — |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' EquityIn 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 Company sold 3,622,186 shares of common stock resulting in net proceeds of approximately $98.2 million through December 31, 2021 under the Sales Agreement. In April 2021, the Company entered into Amendment No. 1 to the Sales Agreement which increased 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. In March 2023, the Company terminated the Sales Agreement and entered into a new 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 ATM Offering. During the nine months ended September 30, 2023, the Company sold 95,000 shares of common stock at a weighted average price per share of $6.60, resulting in net proceeds of approximately $0.6 million, net of offering expenses. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
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 , which was amended in March 2018, April 2022 and July 2022, for retifanlimab, an investigational monoclonal antibody that inhibits 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. MacroGenics will manufacture a portion of Incyte’s global commercial supply of retifanlimab. In March 2023, the FDA approved Incyte's Biologics License Application (BLA) for ZYNYZ (retifanlimab-dlwr) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. Incyte has stated it is pursuing development of retifanlimab in potentially registration-enabling studies, including in patients with squamous cell carcinoma of the anal canal, MSI-high endometrial cancer and non-small cell lung cancer. Incyte is also pursuing development of retifanlimab in combination with multiple product candidates from its pipeline. Under the terms of the Incyte License Agreement, as amended, Incyte will lead global development of retifanlimab. Assuming successful development and commercialization by Incyte in multiple indications, the Company could receive up to a total of $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 September 30, 2023 , the Company has recognized $115.0 million in development milestones under the Incyte License Agreement, including $15.0 million received following the FDA approval of ZYNYZ. The Company is also eligible to receive tiered royalties of 15% to 24% on 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) at inception 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 September 30, 2023 , it became probable that a significant reversal of cumulative revenue would not occur for development milestones totaling $115.0 million related to clinical and regulatory activities related to the further advancement of retifanlimab . 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. The Company recognized the $15.0 million ZYNYZ approval milestone as revenue under the Incyte License Agreement during the nine months ended September 30, 2023. $30.0 million in revenue was recognized under the Incyte License Agreement during the three and nine months ended September 30, 2022. 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 September 30, 2023 and 2022, the Company recognized revenue of $0.2 million and $0.1 million, respectively, for services performed under the Incyte Clinical Supply Agreement. During the nine months ended September 30, 2023 and 2022, the Company recognized revenue of $1.7 million and $0.6 million, respectively, for services performed under the Incyte Clinical Supply Agreement. Gilead Sciences, Inc In October 2022, the Company and Gilead Sciences, Inc. (Gilead) entered into an exclusive option and collaboration agreement (Gilead Agreement) to develop and commercialize MGD024, an investigational, bispecific antibody that binds CD123 and CD3, and create bispecific cancer antibodies using the Company’s DART platform and undertake their early development under a maximum of two separate bispecific cancer target research programs. Under the agreement, the Company will continue the ongoing phase 1 trial for MGD024 accordi ng to a development plan , during which Gilead will have the right to exercise an option granted to Gilead to obtain an exclusive license under the Company’s intellectual property to develop and commercialize MGD024 and other bispecific antibodies of MacroGenics that bind CD123 and CD3 (CD123 Option). The agreement also grants Gilead the right, within its first two years, to nominate a bispecific cancer target set for up to two research programs conducted by the Company and to exercise separate options to obtain an exclusive license for the development, commercialization and exploitation of molecules created under each research program (Research Program Option). Gilead nominated the first of the two research programs in September 2023. Under the terms of the Gilead Agreement, in October 2022 Gilead paid the Company an upfront payment of $60.0 million . Assuming Gilead exercises the CD123 Option and Research Program Option and successfully develops and commercializes MGD024, or other CD123 products developed under the agreement, and products result from the two additional research programs, the Company would be eligible to receive up to $1.7 billion in target nomination, option fees, and development, regulatory and commercial milestones. Assuming exercise of the CD123 Option, the Company will also be eligible to receive tiered, low double-digit royalties on worldwide net sales of MGD024 (or other CD123 products developed under the agreement) and assuming exercise of the Research Program Option, a flat royalty on worldwide net sales of any products resulting from the two research programs. The Company evaluated the Gilead Agreement under the provisions of ASC 606 and identified the following material promises under the agreement: (i) a license to perform any activities allocated to Gilead under the MGD024 development plan ; (ii) development activities regarding MGD024, including manufacturing, research and early clinical development activities, necessary to deliver an informational package of development and clinical data, information and materials specified in the Gilead Agreement during the period in which Gilead can exercise the CD123 Option; (iii) the CD123 Option and (iv) the Research Program Option . The Company concluded that the license under the MGD024 developme nt plan and development activities are not distinct from one another, as the license has limited value without the Company’s performance of the development activities. Therefore, the Company determined that the development term license and development activities should be combined into a single performance obligation (Development Activities). The CD123 Option is considered a material right as the value of the exclusive license exceeds the payment to be made by Gilead if they exercise their option to obtain an exclusive license to develop and commercialize MGD024 or an alternative CD123 product, and is therefore a distinct performance obligation. The Company determined that the Research Program Option does not provide a material right, as there is no discount on its standalone selling price. In accordance with ASC 606, the Company determined that the initial transaction price under the Gilead Agreement was $60.0 million, consisting of the upfront, non-refundable payment paid by Gilead. The CD123 Option and Research Program Option payments are excluded from the initial transaction price at contract inception along with any future development, regulatory, and commercial milestone payments (including royalties) following the CD123 Option and Research Program Option exercise. The Company reassesses the amount of variable consideration included in the transaction price every reporting period. The Company allocated the $60.0 million upfront payment in the transaction price to the Development Activities and the CD123 Option based on each performance obligation’s relative standalone selling price. The standalone selling price for the Development Activities was calculated using an expected cost-plus margin approach for the pre-option development timeline. For the standalone selling price of the CD123 Option, the Company utilized an income-based approach which included the following key assumptions: post-option development timeline and costs, forecasted revenues, discount rates and probabilities of technical and regulatory success. The Company is recognizing revenue related to the Development Activities performance obligation over the estimated period to complete the Development Activities using an input method reflecting the costs incurred (including resources consumed and labor hours expended) related to the Development Activities. The Company will defer revenue recognition related to the CD123 Option. If Gilead exercises the CD123 Option and obtains an exclusive license, the Company will recognize revenue as it fulfills its obligations under the Gilead Agreement. If the CD123 Option is not exercised, the Company will recognize the entirety of the revenue in the period when the CD123 Option expires. During the three and nine months ended September 30, 2023, the Company recorded revenue of $0.4 million and $1.0 million, respectively, related to the Gilead Agreement. As of September 30, 2023, $58.9 million in revenue was deferred under this agreement, $2.2 million of which was current and $56.7 million of which was non-current. As of December 31, 2022, $59.8 million in revenue was deferred under this agreement, $1.8 million of which was current and $58.0 million of which was non-current. During the three months ended September 30, 2023, the Company and Gilead executed a Letter Agreement through which Gilead nominated the first of the two research programs contemplated in the Gilead Agreement (First Research Program), the Company granted Gilead a research license, and the parties agreed on a research plan for the First Research Program under which the Company will provide research and development services. Gilead paid the Company a $15.7 million nomination fee, which was received by the Company in October 2023. The Company evaluated the Letter Agreement under the terms of ASC 606, and concluded that it is a modification to the Gilead Agreement that results in a separate contract since the modification is for additional goods and services that are distinct and at standalone selling price. 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 these should be combined into a single performance obligation. Gilead also has the exclusive option to pay the Company $10.0 million to obtain a license to exploit the research molecule and research product with respect to the First Research Program. The Company determined that this exclusive option does not provide a material right, as there is no discount on its standalone selling price. In accordance with ASC 606, the Company determined that the initial transaction price for the First Research Program agreement was $15.7 million, consisting of the non-refundable payment paid by Gilead. The Company is recognizing revenue over the estimated period to complete the services using the input method reflecting the costs incurred (including resources consumed and labor hours expended) related to the research and development services. During the three and nine months ended September 30, 2023, the Company recorded revenue of $0.1 million related to the First Research Program. As of September 30, 2023, $15.6 million in revenue was deferred under this agreement, $10.0 million of which was current and $5.6 million of which was non-current. 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 and received $9.0 million through September 30, 2023. 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 September 30, 2023 , 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, $8.1 million net of value-added tax withholdings, was added to the estimated transaction price and was recognized as revenue . No revenue was recognized under the 2018 Zai Lab Agreement during the three and nine months ended September 30, 2023. During the three months ended September 30, 2022, no revenue was recognized, and during the nine months ended September 30, 2022, the Company recognized revenue of $4.9 million under the 2018 Zai Lab Agreement. 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). In August 2022, the Company and Zai Lab agreed to discontinue research and development of the Lead Program. In August 2023, the parties mutually agreed to terminate the 2021 Zai Lab Agreement. 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 a 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. The Company evaluated the 2021 Zai Lab Agreement under the provisions of ASC 606 and identified four performance obligations included in the 2021 Zai Lab Agreement.The Company concluded that the estimated transaction price was $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 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 believed a market participant was 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 was recognized over time as the research and development activities were performed. The Company utilized a cost-based input method according to costs incurred to date compared to estimated total costs. The transfer of control occured over this time period and, in management’s judgment, was 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 2021. During the three and nine months ended September 30, 2023, no revenue was recognized under the 2021 Zai Lab Agreement. During the three and nine months ended September 30, 2022, the Company recognized revenue of $1.8 million and $16.8 million, respectively, under the 2021 Zai Lab Agreement. Provention Bio, Inc. In 2018, the Company entered into a license agreement with Provention pursuant to which the Company granted Provention exclusive global rights for the purpose of developing and commercializing MGD010 (renamed PRV-3279), a CD32B x CD79B DART molecule being developed for the treatment of autoimmune indications (Provention License Agreement). As partial consideration for the Provention License Agreement, Provention granted the Company a warrant to purchase shares of Provention’s common stock at an exercise price of $2.50 per share. If Provention successfully develops, obtains regulatory approval for, and commercializes PRV-3279, the Company will be eligible to receive up to $65.0 million in development and regulatory milestones and up to $225.0 million in commercial milestones. As of September 30, 2023, the Company has not recognized any milestone revenue under this agreement. If commercialized, the Company would be eligible to receive single-digit royalties on net sales of the product. The license agreement may be terminated by either party upon a material breach or bankruptcy of the other party, by Provention without cause upon prior notice to the Company, and by the Company in the event that Provention challenges the validity of any licensed patent under the agreement, but only with respect to the challenged patent. Also, in 2018, the Company entered into the Provention APA pursuant to which Provention acquired the Company’s interest in teplizumab (renamed PRV-031), a monoclonal antibody being developed for the treatment of type 1 diabetes. As partial consideration for the Provention APA, Provention granted the Company a warrant to purchase shares of Provention’s common stock at an exercise price of $2.50 per share. Under the Provention APA, Provention is obligated to pay the Company contingent milestone payments totaling $170.0 million upon the achievement of certain regulatory milestones. In addition, Provention is obligated to make contingent milestone payments to the Company totaling $225.0 million upon the achievement of certain commercial milestones as well as single-digit royalties on net sales of the product. In March 2023, the Company entered into a Royalty Purchase Agreement with DRI; see Note 6, Royalty Monetization Arrangement, for additional information. The FDA approved the BLA for TZIELD in November 2022, and the Company recognized $60.0 million in revenue related to this regulatory milestone during the year ended December 31, 2022. In November 2022, the Company and Provention amended the Provention APA. Under this amendment, the milestone for first approval was split into four equal payments, all of which were received prior to June 30, 2023. Provention has also agreed to pay third-party obligations, including low single-digit royalties of which a portion is creditable against royalties payable to the Company, aggregate milestone payments of up to approximately $1.3 million and other consideration, for certain third-party intellectual property under agreements Provention assumed pursuant to the Provention APA. Further, Provention is required to pay the Company a low double-digit percentage of certain consideration to the extent it is received in connection with a future grant of rights to PRV-031 by Provention to a third party. The Company evaluated the Provention License Agreement and Provention APA under the provisions of ASC 606 and determined that they should be accounted for as a single contract and identified two performance obligations within that contract: (i) the license of MGD010 and (ii) the title to teplizumab. The Company determined that the transaction price of the Provention agreements was $6.1 million, based on the Black-Scholes valuation of the warrants to purchase a total of 2,432,688 shares of Provention's common stock. The transaction price was allocated to each performance obligation based on the number of shares of common stock the Company is entitled to purchase under each warrant. The potential development and regulatory milestone payments are fully constrained until the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods, and as such were excluded from the initial transaction price. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur, therefore they have also been excluded from the transaction price. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. The Company recognized revenue of $6.1 million when it satisfied its performance obligations under the agreements and transferred the MGD010 license and teplizumab assets to Provention in 2018. In 2019, the Company exercised the warrants on a cashless basis, and subsequently sold all the shares of Provention common stock acquired through the exercise. No shares of Provention stock were held subsequent to the sale of stock in 2019. During the year ended December 31, 2022, it became probable that a significant reversal of cumulative revenue would not occur for a regulatory milestone of $60.0 million , t herefore the associated consideration was added to the estimated transaction price and was recognized as revenue. On April 27, 2023, Sanofi completed its acquisition of Provention. Concurrently on April 27, 2023, the Company entered into a Tripartite Agreement, as discussed in Note 6, Royalty Monetization Arrangement. Also on April 27, 2023, the Company and a subsidiary of Sanofi entered into a Side Letter Agreement which specified certain post-closing covenants and also accelerated certain payments due to the Company under the Provention APA upon the closing of the merger between Sanofi and Provention. The Company evaluated the Side Letter Agreement as a contract modification under the provisions of ASC 606. As a result, during the nine months ended September 30, 2023 , the Company recognized $5.5 million related to other consideration under the Provention APA and Side Letter Agreement. During the nine months ended September 30, 2023, the Company recognized $0.3 million in royalty revenue under the Provention APA based on sales of TZIELD. As discussed in Note 6, in September 2023, the Company and Sanofi executed Amendment No. 2 to the Provention APA and terminated the Royalty Purchase Agreement with DRI. As a result, the remaining $50.0 million milestone under the Royalty Purchase Agreement was incorporated into the Provention APA. The Company evaluated the amendment as a contract modification under the provisions of ASC 606 which did not result in any revenue being recognized during the three or nine months ended September 30, 2023. 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), lead clinical development of enoblituzumab in its territories, and will participate in global studies conducted by the Company. The I-Mab License Agreement was terminated effective as of February 25, 2023. Under the terms of the I-Mab License Agreement, I-Mab paid the Company an upfront payment of $15.0 million, and $5.0 million of milestone revenue has been earned from the inception of the I-Mab License Agreement through termination of the agreement. The Company evaluated the I-Mab License Agreement under the provisions of ASC 606 and identified 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 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. Revenue under the I-Mab License Agreement was 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, was the best measure of progress towards satisfying the performance obligations. During the three and nine months ended September 30, 2023, the Company recognized no revenue under the I-Mab License Agreement. During the three and nine months ended Sept |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
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 nine months ended September 30, 2023, 48,280 shares of common stock were purchased under the 2016 ESPP. Employee Stock Incentive Plans Effective February 2003, the Company implemented the 2003 Equity Incentive Plan (2003 Plan), and it was amended and approved by the Company's stockholders in 2005. Stock options granted under the 2003 Plan may be either incentive stock options as defined by the 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 Equity Incentive Plan (2013 Plan), up to a specified number of shares. 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. In May 2023, the 2013 Plan was terminated, and no further awards may be issued under the plan. If an option granted under the 2013 Plan 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 will become available for issuance under the 2023 Equity Incentive Plan (2023 Plan). The 2023 Plan was effective as of stockholder approval in May 2023. The 2023 Plan provides for grants of stock options and other stock-based awards, as well as cash-based performance awards. Initially, the maximum number of shares of the Company’s common stock that may be issued under the 2023 Plan will not exceed 4,850,000 shares. 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. The following stock-based compensation expense was recognized for the periods indicated (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 2,335 $ 2,571 $ 6,996 $ 7,621 Selling, general and administrative 2,455 2,552 7,018 8,076 Total stock-based compensation expense $ 4,790 $ 5,123 $ 14,014 $ 15,697 Employee stock options The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions in the following table for options issued during the period indicated: Nine Months Ended September 30, 2023 2022 Expected dividend yield 0% 0% Expected volatility 76.1% -94.9% 87.8% - 90.8% Risk-free interest rate 3.5% - 4.4% 1.4% - 3.6% Expected term 5.88 years 5.95 years The following table summarizes stock option activity during the nine months ended September 30, 2023: Shares Weighted- Weighted-Average Aggregate Outstanding, December 31, 2022 10,098,929 $ 18.58 6.5 Granted 3,267,727 4.91 Exercised (26,146) 3.34 Forfeited (293,161) 9.78 Expired (367,054) 19.77 Outstanding, September 30, 2023 12,680,295 15.26 6.7 $ 301 As of September 30, 2023: Exercisable 7,836,655 19.50 5.4 186 Vested and expected to vest 11,733,021 15.75 6.5 278 The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2023 and 2022 was $3.78 and $6.89, respectively. The total intrinsic value of options exercised during the nine months ended September 30, 2023 and 2022 was $0.1 million and $0.5 million, respectively. The total cash received for options exercised during the nine months ended September 30, 2023 and 2022 was $0.1 million and $0.3 million, respectively. The total fair value of shares vested in the nine months ended September 30, 2023 and 2022 was approximately $13.6 million and $15.1 million, respectively. As of September 30, 2023, the total unrecognized compensation expense related to unvested stock options, net of related forfeiture estimates, was approximately $22.6 million, which the Company expects to recognize over a weighted-average period of approximately 1.3 years. Restricted Stock Units The Company awards restricted stock units (RSUs) to employees. RSUs are valued based on the closing price of the Company’s common stock on the date of the grant. The fair value of RSUs is recognized and amortized on a straight-line basis over the requisite service period of the award . The following table summarizes RSU activity during the nine months ended September 30, 2023: Shares Weighted-Average Grant Date Fair Value Outstanding, December 31, 2022 415,084 $ 8.83 Granted 696,635 4.84 Vested (135,396) 8.32 Forfeited (68,046) 7.53 Outstanding, September 30, 2023 908,277 5.95 At September 30, 2023, there was $2.9 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. |
In-Licensing Arrangement
In-Licensing Arrangement | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
In-licensing arrangement | In-licensing arrangementIn January 2022, the Company entered into a non-exclusive license agreement with Synaffix B.V., a Lonza company, (Synaffix) to develop, manufacture and commercialize up to three antibody-drug conjugate targets using Synaffix’s proprietary technology. The Company made an upfront payment to Synaffix upon contract execution. In March 2023, the Company and Synaffix amended the agreement, adding four additional targets. Assuming all seven targets are successfully developed and commercialized, the Company would be obligated to pay up to $2.8 billion for development, regulatory and sales milestones. Finally, pursuant to the terms of this license agreement, as amended, upon commencement of commercial sales of any products developed from these targets, the Company would be required to pay Synaffix tiered royalties in the low‑single digit percentages on net sales of the respective products. The Company may terminate this agreement at any time with 30 days’ notice to Synaffix. Amounts paid to Synaffix under this agreement are recorded as research and development expense in the consolidated statement of operations. No expense was incurred under this agreement during the three months ended September 30, 2023 or 2022. The Company incurred $1.7 million and $1.0 million in expense under this agreement during the nine months ended September 30, 2023 and 2022, respectively. |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | Net Income (Loss) Per Share Basic income (loss) per common share is determined by dividing income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted income (loss) per share is computed by dividing the income (loss) attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company's stock option grants and RSUs. 12,607,056 and 12,514,638 stock options and RSUs (common stock equivalents) were excluded from the calculation of diluted income per share for the three and nine months ended September 30, 2023, respectively, because their inclusion would have been anti-dilutive. Basic and diluted income (loss) per common share is computed as follows (in thousands except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net income (loss) used for calculation of basic and diluted EPS $ 17,554 $ (24,813) $ 37,014 $ (132,560) Denominator: Weighted average shares outstanding, basic 61,980,680 61,459,831 61,890,824 61,390,143 Effect of dilutive securities: Stock options and restricted stock units 263,922 — 199,519 — Weighted average shares outstanding, diluted 62,244,602 61,459,831 62,090,343 61,390,143 Net income (loss) per share, basic $ 0.28 $ (0.40) $ 0.60 $ (2.16) Net income (loss) per share, diluted $ 0.28 $ (0.40) $ 0.60 $ (2.16) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
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. The accompanying unaudited interim consolidated financial statements include the accounts of MacroGenics, Inc. and its wholly owned subsidiaries, MacroGenics UK Limited and MacroGenics Limited. All intercompany accounts and transactions have been eliminated in consolidation. These consolidated financial statements and related notes should be read in conjunction with the financial statements and notes thereto included in the Company's 2022 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 15, 2023. |
Liability related to the sale of future royalties and related interest expense | Liability related to the sale of future royalties and related interest expense The Company assesses the relevant accounting criteria under Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 470, Debt (ASC 470) to determine whether the upfront payment received from the purchaser should be accounted for as debt or deferred income depending on the facts and circumstances. If the criteria in ASC 470 is met, the Company accounts for net proceeds from sales of its rights to receive future royalty payments as a liability that is amortized using the effective interest method over the term of the arrangement. The liability related to future royalties is presented net of unamortized issuance costs on the consolidated balance sheets. Interest expense on the liability related to future royalties is recognized using the effective interest rate method over the life of the arrangement. The Company calculates an effective interest rate which will amortize its related obligation to zero over the anticipated repayment period. The liability related to future royalties and the related interest expense are based on the Company’s current estimates of future royalties expected to be received over the life of the arrangement, which the Company determines by using internal sales projections and external information from market data sources, which are considered Level 3 inputs. The Company periodically assesses the expected payments and to the extent the Company’s estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. Non-cash amortization is reflected as interest expense in the consolidated statements of operations and comprehensive income (loss). Upon changes in facts and circumstances, for example as a result of a modification to the existing agreements, the Company re-evaluates its rights and obligations and accounts for the change in accordance with the respective accounting guidance. |
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 2022 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 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) | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, 2023 Total Level 1 Level 2 Assets: Money market funds $ 51,137 $ 51,137 $ — U.S. Treasury securities 26,038 26,038 — Government-sponsored enterprises 83,695 — 83,695 Corporate debt securities 56,801 — 56,801 Total assets measured at fair value (a) $ 217,671 $ 77,175 $ 140,496 Fair Value Measurements at December 31, 2022 Total Level 1 Level 2 Assets: Money market funds $ 41,564 $ 41,564 $ — Government-sponsored enterprises 32,811 — 32,811 Corporate debt securities 17,626 — 17,626 Total assets measured at fair value (b) $ 92,001 $ 41,564 $ 50,437 (a) Total assets measured at fair value at September 30, 2023 includes approximately $51.1 million reported in cash and cash equivalents on the consolidated balance sheet. (b) Total assets measured at fair value at December 31, 2022 includes approximately $46.5 million reported in cash and cash equivalents on the consolidated balance sheet. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-sale Marketable Securities | The following tables summarize the Company's marketable debt securities (in thousands): September 30, 2023 Amortized Gross Gross Fair U.S. Treasury securities $ 26,050 $ — $ (12) $ 26,038 Government-sponsored enterprises 83,671 40 (16) 83,695 Corporate debt securities 56,847 — (46) 56,801 Total $ 166,568 $ 40 $ (74) $ 166,534 December 31, 2022 Amortized Gross Gross Fair Government-sponsored enterprises $ 32,812 $ 5 $ (7) $ 32,810 Corporate debt securities 12,655 1 (4) 12,652 Total $ 45,467 $ 6 $ (11) $ 45,462 |
Inventory, Net (Tables)
Inventory, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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): September 30, 2023 December 31, 2022 Work in process $ — $ 409 Finished goods 1,066 1,042 Total inventory, net $ 1,066 $ 1,451 |
Royalty Monetization Arrangem_2
Royalty Monetization Arrangement (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Liability related to future royalties [Abstract] | |
Liability Related to Future Royalty | Changes to the liability related to future royalties were as follows for the nine months ended September 30, 2023 (in thousands): Liability related to future royalties - beginning balance $ — Proceeds from sale of future royalties 150,000 Deferred transaction costs (344) Royalty revenue payable to DRI (156) Interest expense recognized 1,430 Gain on royalty monetization arrangement (150,930) Liability related to future royalties - ending balance $ — |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 2,335 $ 2,571 $ 6,996 $ 7,621 Selling, general and administrative 2,455 2,552 7,018 8,076 Total stock-based compensation expense $ 4,790 $ 5,123 $ 14,014 $ 15,697 |
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: Nine Months Ended September 30, 2023 2022 Expected dividend yield 0% 0% Expected volatility 76.1% -94.9% 87.8% - 90.8% Risk-free interest rate 3.5% - 4.4% 1.4% - 3.6% Expected term 5.88 years 5.95 years |
Schedule of Stock Options Roll Forward | The following table summarizes stock option activity during the nine months ended September 30, 2023: Shares Weighted- Weighted-Average Aggregate Outstanding, December 31, 2022 10,098,929 $ 18.58 6.5 Granted 3,267,727 4.91 Exercised (26,146) 3.34 Forfeited (293,161) 9.78 Expired (367,054) 19.77 Outstanding, September 30, 2023 12,680,295 15.26 6.7 $ 301 As of September 30, 2023: Exercisable 7,836,655 19.50 5.4 186 Vested and expected to vest 11,733,021 15.75 6.5 278 |
Schedule of RSU Activity | The following table summarizes RSU activity during the nine months ended September 30, 2023: Shares Weighted-Average Grant Date Fair Value Outstanding, December 31, 2022 415,084 $ 8.83 Granted 696,635 4.84 Vested (135,396) 8.32 Forfeited (68,046) 7.53 Outstanding, September 30, 2023 908,277 5.95 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Loss Per Common Share Computation | Basic and diluted income (loss) per common share is computed as follows (in thousands except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net income (loss) used for calculation of basic and diluted EPS $ 17,554 $ (24,813) $ 37,014 $ (132,560) Denominator: Weighted average shares outstanding, basic 61,980,680 61,459,831 61,890,824 61,390,143 Effect of dilutive securities: Stock options and restricted stock units 263,922 — 199,519 — Weighted average shares outstanding, diluted 62,244,602 61,459,831 62,090,343 61,390,143 Net income (loss) per share, basic $ 0.28 $ (0.40) $ 0.60 $ (2.16) Net income (loss) per share, diluted $ 0.28 $ (0.40) $ 0.60 $ (2.16) |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Assets: | ||
Securities | $ 166,534 | $ 45,462 |
Fair Value Measurements, Recurring Basis | ||
Assets: | ||
Cash and cash equivalents | 51,100 | 46,500 |
Total assets measured at fair value | 217,671 | 92,001 |
Fair Value Measurements, Recurring Basis | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 77,175 | 41,564 |
Fair Value Measurements, Recurring Basis | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 140,496 | 50,437 |
Fair Value Measurements, Recurring Basis | Money market funds | ||
Assets: | ||
Cash and cash equivalents | 51,137 | 41,564 |
Fair Value Measurements, Recurring Basis | Money market funds | Level 1 | ||
Assets: | ||
Cash and cash equivalents | 51,137 | 41,564 |
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 | 26,038 | |
Fair Value Measurements, Recurring Basis | U.S. Treasury securities | Level 1 | ||
Assets: | ||
Securities | 26,038 | |
Fair Value Measurements, Recurring Basis | U.S. Treasury securities | Level 2 | ||
Assets: | ||
Securities | 0 | |
Fair Value Measurements, Recurring Basis | Government-sponsored enterprises | ||
Assets: | ||
Securities | 83,695 | 32,811 |
Fair Value Measurements, Recurring Basis | Government-sponsored enterprises | Level 1 | ||
Assets: | ||
Securities | 0 | 0 |
Fair Value Measurements, Recurring Basis | Government-sponsored enterprises | Level 2 | ||
Assets: | ||
Securities | 83,695 | 32,811 |
Fair Value Measurements, Recurring Basis | Corporate debt securities | ||
Assets: | ||
Securities | 56,801 | 17,626 |
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 | $ 56,801 | $ 17,626 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 166,568,000 | $ 45,467,000 |
Gross Unrealized Gains | 40,000 | 6,000 |
Gross Unrealized Losses | (74,000) | (11,000) |
Fair Value | 166,534,000 | 45,462,000 |
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 | 26,050,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (12,000) | |
Fair Value | 26,038,000 | |
Government-sponsored enterprises | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 83,671,000 | 32,812,000 |
Gross Unrealized Gains | 40,000 | 5,000 |
Gross Unrealized Losses | (16,000) | (7,000) |
Fair Value | 83,695,000 | 32,810,000 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 56,847,000 | 12,655,000 |
Gross Unrealized Gains | 0 | 1,000 |
Gross Unrealized Losses | (46,000) | (4,000) |
Fair Value | $ 56,801,000 | $ 12,652,000 |
Inventory, Net (Details)
Inventory, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Work in process | $ 0 | $ 409 |
Finished goods | 1,066 | 1,042 |
Total inventory, net | 1,066 | 1,451 |
Inventory valuation reserves | $ 4,900 | $ 4,900 |
Royalty Monetization Arrangem_3
Royalty Monetization Arrangement - Narrative (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Mar. 08, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Liability related to future royalty [Line Items] | |||
Net proceeds from sale of future royalties | $ 149,655 | $ 0 | |
DRI Healthcare Acquisitions LP (DRI) | |||
Liability related to future royalty [Line Items] | |||
Upfront Payment | $ 100,000 | ||
Transaction Cost | $ 300 | ||
Potential proceeds from royalties (percent) | 50% | ||
Future Revenue | $ 50,000 |
Royalty Monetization Arrangem_4
Royalty Monetization Arrangement - Rollforward (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Liability related to future royalties [Roll Forward] | ||||||
Proceeds from sale of future royalties | $ 150,000 | |||||
Deferred transaction costs | (344) | |||||
Principal payments on royalty monetization arrangement | (156) | $ 0 | ||||
Non-cash interest expense recognized | 1,430 | 0 | ||||
Gain on modification of debt | $ 50,000 | $ 100,900 | $ 0 | 150,930 | $ 0 | |
Liability related to future royalties [Abstract] | $ 0 | $ 0 | $ 0 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||||||
Apr. 30, 2021 | Nov. 30, 2020 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Jun. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Class of Stock [Line Items] | ||||||||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | |||||||
Options outstanding (in shares) | 12,680,295 | 12,680,295 | 10,098,929 | |||||||
Cash received for options exercised | $ 0.1 | $ 0.3 | ||||||||
Common Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued or sold (in shares) | 36,135 | 36,135 | 95,000 | |||||||
At the Market Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Maximum amount available for issuance | $ 100 | |||||||||
Number of shares sold (in shares) | 3,622,186 | 95,000 | ||||||||
Sales of stock purchase price (in dollars per share) | $ 6.6 | $ 6.6 | ||||||||
Proceeds of stock sale | $ 98.2 | $ 0.6 | ||||||||
Maximum amount available for issuance, increase | $ 300 |
Revenue- Incyte Corporation (De
Revenue- Incyte Corporation (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 7 Months Ended | 9 Months Ended | 12 Months Ended | 24 Months Ended | 69 Months Ended | ||||||
Mar. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Jul. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2018 USD ($) performanceObligation | Dec. 31, 2018 USD ($) performanceObligation | Sep. 30, 2023 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jan. 31, 2022 | |
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenues | $ 10,397 | $ 41,734 | $ 48,029 | $ 78,842 | |||||||||
Deferred revenue, current | 18,584 | 18,584 | $ 18,584 | $ 9,988 | |||||||||
Deferred revenue, net of current portion | 64,260 | 64,260 | 64,260 | $ 59,480 | |||||||||
Incyte Corporation | Incyte MGA012 Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Non-refundable upfront payment | $ 150,000 | ||||||||||||
Potential commercial milestone payments under agreement | 330,000 | $ 330,000 | |||||||||||
Potential development and regulatory milestone payments under agreement | 435,000 | 435,000 | |||||||||||
Development and regulatory milestones recognized | $ 15,000 | 115,000 | |||||||||||
Collaborative agreement transaction price | $ 154,000 | 154,000 | |||||||||||
Variable consideration recognized | $ 4,000 | ||||||||||||
Number of performance obligations | performanceObligation | 2 | 2 | |||||||||||
I-Mab | I-Mab Biopharma Collaboration and License Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Non-refundable upfront payment | $ 15,000 | ||||||||||||
Revenues | 0 | 3,800 | 0 | 4,500 | |||||||||
Development and regulatory milestones recognized | 5,000 | ||||||||||||
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% | ||||||||||||
Revenues From License Agreements | Incyte Corporation | Incyte MGA012 Agreement | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenues | 30,000 | 15,000 | 30,000 | $ 150,000 | |||||||||
Revenues From License Agreements | Incyte Corporation | Incyte MGA012 Clinical Services | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenues | 200 | 100 | 1,700 | 600 | |||||||||
RevenuesFromCMOAgreementsMember | Incyte Corporation | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Non-refundable upfront payment | $ 10,000 | ||||||||||||
Annual Fixed Payments | 14,400 | 14,400 | 14,400 | ||||||||||
Revenues | 4,500 | $ 1,100 | 9,600 | $ 5,100 | |||||||||
Deferred revenue | 7,000 | 7,000 | 7,000 | ||||||||||
Deferred revenue, current | 6,400 | 6,400 | 6,400 | ||||||||||
Deferred revenue, net of current portion | 600 | 600 | 600 | ||||||||||
RevenuesFromCMOAmendmentAgreement | Incyte Corporation | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Annual Fixed Payments | $ 19,500 | ||||||||||||
Additional Payments | $ 5,100 | $ 5,100 | $ 5,100 | ||||||||||
Manufacturing Services | Incyte Corporation | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Extension term | 1 year | ||||||||||||
Manufacturing Services | Incyte Corporation | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-02-01 | |||||||||||||
Collaboration And Other Agreements [Line Items] | |||||||||||||
Revenue, remaining performance obligation, expected timing of satisfaction | 3 years |
Revenue- Gilead Science Inc (De
Revenue- Gilead Science Inc (Details) - USD ($) $ in Thousands | 3 Months Ended | 7 Months Ended | 9 Months Ended | ||||
Oct. 14, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jul. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Collaboration And Other Agreements [Line Items] | |||||||
Revenues | $ 10,397 | $ 41,734 | $ 48,029 | $ 78,842 | |||
Deferred revenue, current | 18,584 | 18,584 | $ 9,988 | ||||
Deferred revenue, net of current portion | 64,260 | 64,260 | 59,480 | ||||
Gilead | 2022 Gilead Collaboration And License Agreement | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Non-refundable upfront payment | $ 60,000 | ||||||
Revenues | 400 | 1,000 | |||||
Deferred revenue | 58,900 | 58,900 | 59,800 | ||||
Deferred revenue, current | 2,200 | 2,200 | 1,800 | ||||
Deferred revenue, net of current portion | $ 56,700 | $ 56,700 | $ 58,000 | ||||
Potential target nomination, option fees and milestone payments | $ 1,700,000 | ||||||
Gilead | Gilead First Research Program | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Revenues | 100 | 100 | |||||
Deferred revenue | 15,600 | 15,600 | |||||
Deferred revenue, current | 10,000 | 10,000 | |||||
Deferred revenue, net of current portion | 5,600 | 5,600 | |||||
Revenue, Remaining Performance Obligation, Amount | 15,700 | 15,700 | |||||
Potential option fees | $ 10,000 | $ 10,000 |
Revenue - Zai Lab (Details)
Revenue - Zai Lab (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 27 Months Ended | ||||||
Jun. 30, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Mar. 31, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2022 | Mar. 31, 2022 | Jun. 15, 2021 | |
Collaboration And Other Agreements [Line Items] | ||||||||||
Revenues | $ 10,397 | $ 41,734 | $ 48,029 | $ 78,842 | ||||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | |||||||
Deferred revenue, current | $ 18,584 | $ 18,584 | $ 9,988 | |||||||
Deferred revenue, net of current portion | 64,260 | 64,260 | $ 59,480 | |||||||
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 | 0 | 0 | 0 | 4,900 | ||||||
Milestones Value Added Tax | $ 8,100 | |||||||||
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% | |||||||||
2021 Zai Lab Agreements | Zai Labs | ||||||||||
Collaboration And Other Agreements [Line Items] | ||||||||||
Non-refundable upfront payment | $ 25,000 | |||||||||
Revenues | $ 0 | $ 1,800 | $ 0 | $ 16,800 | ||||||
Proceeds of stock sale | 30,000 | |||||||||
Sales of stock purchase price (in dollars per share) | $ 31.3 | |||||||||
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 |
Revenue - I-Mab Biopharma (Deta
Revenue - I-Mab Biopharma (Details) - USD ($) $ in Thousands | 3 Months Ended | 7 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Jul. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Collaboration And Other Agreements [Line Items] | |||||||
Revenues | $ 10,397 | $ 41,734 | $ 48,029 | $ 78,842 | |||
Deferred revenue, current | 18,584 | 18,584 | $ 9,988 | ||||
Deferred revenue, net of current portion | 64,260 | 64,260 | 59,480 | ||||
I-Mab | I-Mab Biopharma Collaboration and License Agreement | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Non-refundable upfront payment | $ 15,000 | ||||||
Development and regulatory milestones recognized | 5,000 | ||||||
Revenues | 0 | 3,800 | 0 | 4,500 | |||
One Time Millstone Credit | $ 4,500 | ||||||
Incyte Corporation | RevenuesFromCMOAgreementsMember | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Non-refundable upfront payment | $ 10,000 | ||||||
Revenues | 4,500 | $ 1,100 | 9,600 | $ 5,100 | |||
Deferred revenue | 7,000 | 7,000 | |||||
Deferred revenue, current | 6,400 | 6,400 | |||||
Deferred revenue, net of current portion | $ 600 | $ 600 |
Revenue - NIAID Contract (Detai
Revenue - NIAID Contract (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 15, 2015 Molecule | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | |
Collaboration And Other Agreements [Line Items] | |||||
Revenues | $ 10,397 | $ 41,734 | $ 48,029 | $ 78,842 | |
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 | $ 300 | $ 500 | $ 1,100 | $ 1,500 |
Revenue - Provention (Details)
Revenue - Provention (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Mar. 08, 2023 | Nov. 30, 2022 | May 31, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaboration And Other Agreements [Line Items] | |||||||
Revenues | $ 10,397 | $ 41,734 | $ 48,029 | $ 78,842 | |||
Provention Bio | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Collaborative agreement transaction price | $ 6,100 | ||||||
Collaborative Agreement Consideration Received Common Stock Warrants Number Of Shares | 2,432,688 | ||||||
Provention Bio | Revenues From License Agreements | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Revenues | $ 6,100 | ||||||
Provention Bio | Asset Purchase Agreement | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Revenues | $ 5,500 | 5,500 | |||||
Provention Bio | Royalty | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Revenues | $ 300 | ||||||
Provention Bio | Provention PRV3279 | Provention License Agreement | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Collaborative Agreement Consideration Received Common Stock Warrant Exercise Price Per Share | $ 2.5 | ||||||
Potential development and regulatory milestone payments under agreement | $ 65,000 | ||||||
Potential commercial milestone payments under agreement | $ 225,000 | ||||||
Provention Bio | Provention PRV031 | Asset Purchase Agreement | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Collaborative Agreement Consideration Received Common Stock Warrant Exercise Price Per Share | $ 2.5 | ||||||
Potential development and regulatory milestone payments under agreement | $ 170,000 | ||||||
Potential commercial milestone payments under agreement | 225,000 | ||||||
Development and regulatory milestones recognized | $ 60,000 | ||||||
Potential Milestone Payment To Third Parties For Intellectual Property Under Agreement | $ 1,300 | ||||||
DRI Healthcare Acquisitions LP (DRI) | |||||||
Collaboration And Other Agreements [Line Items] | |||||||
Future Revenue | $ 50,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
May 31, 2017 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | May 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Offering period | 6 months | ||||||
Options outstanding (in shares) | 12,680,295 | 12,680,295 | 10,098,929 | ||||
Weighted-average exercise price of stock options outstanding (in dollars per share) | $ 15.26 | $ 15.26 | $ 18.58 | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Stock-based compensation expense | $ 4,790 | $ 5,123 | $ 14,014 | $ 15,697 | |||
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) | 48,280 | ||||||
StockIncentivePlan2023Member | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based compensation, number of shares authorized (in shares) | 4,850,000 | ||||||
Research and Development | |||||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Stock-based compensation expense | 2,335 | 2,571 | $ 6,996 | 7,621 | |||
General and Administrative | |||||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Stock-based compensation expense | $ 2,455 | $ 2,552 | $ 7,018 | $ 8,076 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option Pricing Assumptions (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Expected term (in years) | 5 years 10 months 17 days | 5 years 11 months 12 days |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 76.10% | 87.80% |
Risk-free interest rate | 3.50% | 1.40% |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 94.90% | 90.80% |
Risk-free interest rate | 4.40% | 3.60% |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Shares | |||
Shares, Outstanding, Beginning Balance (in shares) | 10,098,929 | ||
Shares, Granted (in shares) | 3,267,727 | ||
Shares, Exercised (in shares) | (26,146) | ||
Shares, Forfeited or expired (in shares) | (293,161) | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period | (367,054) | ||
Shares, Outstanding, Ending Balance (in shares) | 12,680,295 | 10,098,929 | |
Shares, Exercisable (in shares) | 7,836,655 | ||
Shares, Vested and expected to vest (in shares) | 11,733,021 | ||
Weighted- Average Exercise Price | |||
Weighted- Average Exercise Price, Outstanding, Beginning Balance (in dollars per share) | $ 18.58 | ||
Weighted- Average Exercise Price, Granted (in dollars per share) | 4.91 | ||
Weighted- Average Exercise Price, Exercised (in dollars per share) | 3.34 | ||
Weighted- Average Exercise Price, Forfeited (in dollars per share) | 9.78 | ||
Weighted- Average Exercise Price, Expired (in dollars per share) | 19.77 | ||
Weighted- Average Exercise Price, Outstanding, Ending Balance (in dollars per share) | 15.26 | $ 18.58 | |
Weighted- Average Exercise Price, Exercisable (in dollars per share) | 19.50 | ||
Weighted- Average Exercise Price, Vested and expected to vest (in dollars per share) | $ 15.75 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Weighted- Average Remaining Contractual Term, Outstanding (in years) | 6 years 8 months 12 days | 6 years 6 months | |
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 6 months | ||
Aggregate Intrinsic Value, Outstanding, Ending Balance | $ 301 | ||
Aggregate Intrinsic Value, Exercisable | 186 | ||
Aggregate Intrinsic Value, Vested and expected to vest | $ 278 | ||
Weighted-average grant-date fair value of options granted (in dollars per share) | $ 3.78 | $ 6.89 | |
Intrinsic value of options exercised | $ 100 | $ 500 | |
Fair value of shares vested | 13,600 | $ 15,100 | |
Unrecognized compensation expense related to non-vested stock-options, net of related forfeiture estimates | $ 22,600 | ||
Unrecognized compensation expense recognition period (in years) | 1 year 3 months 18 days |
Stock-based Compensation - Rest
Stock-based Compensation - Restricted Stock Unit Activity (Details) $ / shares in Units, $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Weighted-Average Grant Date Fair Value | |
Unrecognized compensation expense recognition period (in years) | 1 year 3 months 18 days |
Restricted Stock Units | |
Shares | |
Beginning Balance (in shares) | shares | 415,084 |
Granted (in shares) | shares | 696,635 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Exercised | shares | (135,396) |
Exercised (in dollars per share) | $ / shares | $ 8.32 |
Forfeited or expired (in shares) | shares | (68,046) |
Ending Balance (in shares) | shares | 908,277 |
Weighted-Average Grant Date Fair Value | |
Beginning Balance (in dollars per share) | $ / shares | $ 8.83 |
Granted (in dollars per share) | $ / shares | 4.84 |
Forfeited or expired (in dollars per share) | $ / shares | 7.53 |
Ending Balance (in dollars per share) | $ / shares | $ 5.95 |
Total unrecognized compensation cost | $ | $ 2.9 |
Unrecognized compensation expense recognition period (in years) | 1 year 3 months 18 days |
In-Licensing Arrangement (Detai
In-Licensing Arrangement (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Mar. 31, 2022 | |
In-Licensing arrangement [Line Items] | |||||
Research and development | $ 30,131 | $ 48,191 | $ 119,232 | $ 161,372 | |
Synaffix B.V. | |||||
In-Licensing arrangement [Line Items] | |||||
Potential development and regulatory milestone payments under agreement | $ 2,800,000 | ||||
Research and development | $ 0 | $ 0 | $ 1,700 | $ 1,000 |
Net Income (Loss) Per Share (De
Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Earnings Per Share [Abstract] | ||||||||
Stock options excluded from computation of earnings per share (in shares) | 12,607,056 | 12,514,638 | ||||||
Net loss | $ 17,554 | $ 57,469 | $ (38,009) | $ (24,813) | $ (41,304) | $ (66,443) | $ 37,014 | $ (132,560) |
Basic weighted average common shares outstanding (in shares) | 61,980,680 | 61,459,831 | 61,890,824 | 61,390,143 | ||||
Stock options and restricted stock units | 263,922 | 0 | 199,519 | 0 | ||||
Diluted weighted average common shares outstanding (in shares) | 62,244,602 | 61,459,831 | 62,090,343 | 61,390,143 | ||||
Basic net loss per common share (in usd per share) | $ 0.28 | $ (0.40) | $ 0.60 | $ (2.16) | ||||
Diluted net loss per common share (in usd per share) | $ 0.28 | $ (0.40) | $ 0.60 | $ (2.16) |