Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 25, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Entity File Number | 0-17999 | |
Entity Registrant Name | ImmunoGen, Inc. | |
Entity Incorporation, State or Country Code | MA | |
Entity Tax Identification Number | 04-2726691 | |
Entity Address, Address Line One | 830 Winter Street | |
Entity Address, City or Town | Waltham | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02451 | |
City Area Code | 781 | |
Local Phone Number | 895-0600 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | IMGN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 266,264,274 | |
Entity Central Index Key | 0000855654 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
ASSETS | ||
Cash and cash equivalents | $ 605,535,000 | $ 275,138,000 |
Accounts receivable | 130,694,000 | 12,596,000 |
Unbilled receivable | 3,026,000 | 1,531,000 |
Non-cash royalty receivable | 3,438,000 | 3,851,000 |
Inventory | 5,495,000 | |
Prepaid and other current assets | 18,712,000 | 11,005,000 |
Total current assets | 766,900,000 | 304,121,000 |
Property and equipment, net of accumulated depreciation | 4,431,000 | 4,377,000 |
Operating lease right-of-use assets | 8,338,000 | 10,231,000 |
Long-term inventory | 28,273,000 | 16,196,000 |
Other assets | 14,159,000 | 14,011,000 |
Total assets | 822,101,000 | 348,936,000 |
LIABILITIES AND SHAREHOLDERS' EQUITY | ||
Accounts payable | 24,853,000 | 45,353,000 |
Accrued compensation | 15,155,000 | 11,111,000 |
Other accrued liabilities | 43,571,000 | 38,783,000 |
Current portion of liability related to the sale of future royalties, net of deferred financing costs of $128 and $162, respectively | 9,437,000 | 8,659,000 |
Current portion of operating lease liability | 4,458,000 | 4,096,000 |
Current portion of deferred revenue | 37,186,000 | 13,856,000 |
Total current liabilities | 134,660,000 | 121,858,000 |
Senior secured term loan, net | 72,113,000 | |
Deferred revenue, net of current portion | 26,718,000 | 36,355,000 |
Operating lease liability, net of current portion | 7,759,000 | 11,148,000 |
Liability related to the sale of future royalties, net of current portion and deferred financing costs of $111 and $205, respectively | 16,455,000 | 23,449,000 |
Other long-term liabilities | 2,800,000 | 300,000 |
Total liabilities | 260,505,000 | 193,110,000 |
Commitments and contingencies (Note K) | ||
Shareholders' equity: | ||
Preferred stock, $.01 par value; authorized 5,000 shares; 22 and 0 shares issued and outstanding as of each of September 30, 2023 and December 31, 2022, respectively | ||
Common stock, $.01 par value; authorized 600,000 shares; 265,842 and 220,046 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 2,435,000 | 2,260,000 |
Additional paid-in capital | 2,267,747,000 | 1,847,638,000 |
Accumulated deficit | (1,708,586,000) | (1,694,072,000) |
Total shareholders' equity | 561,596,000 | 155,826,000 |
Total liabilities and shareholders' equity | $ 822,101,000 | $ 348,936,000 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) shares in Thousands, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
CONSOLIDATED BALANCE SHEETS | ||
Sale of future royalties, current portion and deferred financing costs | $ 128 | $ 162 |
Sale of future royalties, noncurrent portion and deferred financing costs | $ 111 | $ 205 |
Preferred stock, par value (in dollars per share) | $ 0.01 | |
Preferred stock, authorized shares | 5,000 | 5,000 |
Preferred stock, shares issued | 22 | 0 |
Preferred stock, shares outstanding | 22 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | |
Common stock, authorized shares | 600,000 | 600,000 |
Common stock, issued shares | 265,842 | 226,046 |
Common stock, outstanding shares | 265,842 | 226,046 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Total revenues | $ 113,425 | $ 15,375 | $ 246,447 | $ 67,615 |
Cost and operating expenses: | ||||
Cost of sales | 2,155 | 3,690 | ||
Research and development | 47,570 | 59,181 | 149,267 | 154,885 |
Selling, general and administrative | 37,744 | 33,623 | 114,116 | 74,064 |
Total cost and operating expenses | 87,469 | 92,804 | 267,073 | 228,949 |
Income (loss) from operations | 25,956 | (77,429) | (20,626) | (161,334) |
Interest income | 7,383 | 1,539 | 14,775 | 2,183 |
Interest expense on term loan | (2,539) | (5,857) | ||
Non-cash interest expense on liability related to the sale of future royalties and term loan | (1,054) | (867) | (2,986) | (3,194) |
Other (expense) income, net | (164) | (998) | (109) | (1,576) |
Net loss before income taxes | 29,582 | (77,755) | (14,803) | (163,921) |
Income tax benefit | (1,166) | (289) | ||
Net loss | $ 30,748 | $ (77,755) | $ (14,514) | $ (163,921) |
Net income (loss) per common share - basic (Note B) | $ 0.10 | $ (0.31) | $ (0.05) | $ (0.65) |
Net income (loss) per common share - diluted (Note B) | $ 0.10 | $ (0.31) | $ (0.05) | $ (0.65) |
Basic weighted average common shares outstanding (in shares) | 273,341 | 253,511 | 265,265 | 253,371 |
Diluted weighted average common shares outstanding (in shares) | 287,590 | 253,511 | 265,265 | 253,371 |
License and milestone fees | ||||
Revenues: | ||||
Total revenues | $ 51 | $ 7,382 | $ 15,122 | $ 45,247 |
Non-cash royalty revenue related to the sale of future royalties | ||||
Revenues: | ||||
Total revenues | 7,355 | $ 7,993 | 17,936 | 21,537 |
Research and development support | ||||
Revenues: | ||||
Total revenues | 855 | 1,310 | $ 831 | |
Product revenue, net | ||||
Revenues: | ||||
Total revenues | $ 105,164 | $ 212,079 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Preferred Stock Series A Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2021 | $ 2,204 | $ 1,794,525 | $ (1,471,143) | $ 325,586 | |
Balance (in shares) at Dec. 31, 2021 | 220,361 | ||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Net loss | (24,145) | (24,145) | |||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | $ 1 | 619 | 620 | ||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan (in shares) | 173 | ||||
Restricted stock units vested (in shares) | 2 | ||||
Stock option and restricted stock compensation expense | 4,196 | 4,196 | |||
Directors' deferred share unit compensation | 211 | 211 | |||
Balance at Mar. 31, 2022 | $ 2,205 | 1,799,551 | (1,495,288) | 306,468 | |
Balance (in shares) at Mar. 31, 2022 | 220,536 | ||||
Balance at Dec. 31, 2021 | $ 2,204 | 1,794,525 | (1,471,143) | 325,586 | |
Balance (in shares) at Dec. 31, 2021 | 220,361 | ||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Net loss | (163,921) | ||||
Balance at Sep. 30, 2022 | $ 2,208 | 1,810,863 | (1,635,064) | 178,007 | |
Balance (in shares) at Sep. 30, 2022 | 220,751 | ||||
Balance at Mar. 31, 2022 | $ 2,205 | 1,799,551 | (1,495,288) | 306,468 | |
Balance (in shares) at Mar. 31, 2022 | 220,536 | ||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Net loss | (62,021) | (62,021) | |||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | $ 1 | 410 | 411 | ||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan (in shares) | 108 | ||||
Stock option and restricted stock compensation expense | 4,760 | 4,760 | |||
Directors' deferred share unit compensation | 213 | 213 | |||
Balance at Jun. 30, 2022 | $ 2,206 | 1,804,934 | (1,557,309) | 249,831 | |
Balance (in shares) at Jun. 30, 2022 | 220,644 | ||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Net loss | (77,755) | (77,755) | |||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | $ 2 | 447 | 449 | ||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan (in shares) | 107 | ||||
Stock option and restricted stock compensation expense | 5,336 | 5,336 | |||
Directors' deferred share unit compensation | 146 | 146 | |||
Balance at Sep. 30, 2022 | $ 2,208 | 1,810,863 | (1,635,064) | 178,007 | |
Balance (in shares) at Sep. 30, 2022 | 220,751 | ||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Net loss | (59,008) | (59,008) | |||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | $ 1 | 423 | 424 | ||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan (in shares) | 103 | ||||
Issuance of common stock, net of issuance costs | $ 51 | 25,596 | 25,647 | ||
Issuance of common stock, net of issuance costs (in shares) | 5,167 | ||||
Restricted stock units vested (in shares) | 25 | ||||
Stock option and restricted stock compensation expense | 10,610 | 10,610 | |||
Directors' deferred share unit compensation | 146 | 146 | |||
Balance at Dec. 31, 2022 | $ 2,260 | 1,847,638 | (1,694,072) | $ 155,826 | |
Balance (in shares) at Dec. 31, 2022 | 226,046 | 226,046 | |||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Issuance of Series A Preferred Stock in exchange for common stock | |||||
Issuance of Series A Preferred Stock in exchange for common stock (in shares) | 0 | ||||
Net loss | (41,014) | $ (41,014) | |||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | $ 1 | 38 | 39 | ||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan (in shares) | 16 | ||||
Stock option and restricted stock compensation expense | 6,916 | 6,916 | |||
Directors' deferred share unit compensation | 151 | 151 | |||
Directors' common stock compensation | 8 | ||||
Balance at Mar. 31, 2023 | $ 2,261 | 1,854,743 | (1,735,086) | 121,918 | |
Balance (in shares) at Mar. 31, 2023 | 226,070 | ||||
Balance at Dec. 31, 2022 | $ 2,260 | 1,847,638 | (1,694,072) | $ 155,826 | |
Balance (in shares) at Dec. 31, 2022 | 226,046 | 226,046 | |||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Net loss | $ (14,514) | ||||
Balance at Sep. 30, 2023 | $ 22 | $ 2,435 | 2,267,747 | (1,708,586) | $ 561,596 |
Balance (in shares) at Sep. 30, 2023 | 265,842 | 265,842 | |||
Balance at Mar. 31, 2023 | $ 2,261 | 1,854,743 | (1,735,086) | $ 121,918 | |
Balance (in shares) at Mar. 31, 2023 | 226,070 | ||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Net loss | (4,248) | (4,248) | |||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | $ 32 | 14,874 | 14,906 | ||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan (in shares) | 3,234 | ||||
Issuance of common stock, net of issuance costs | $ 299 | 350,534 | 350,833 | ||
Issuance of common stock, net of issuance costs (in shares) | 29,900 | ||||
Issuance of common stock pursuant to pre-funded warrant exchange | 11,357 | ||||
Issuance of Series A Preferred Stock in exchange for common stock (common stock) | (21,853) | ||||
Stock option and restricted stock compensation expense | 7,281 | 7,281 | |||
Directors' deferred share unit compensation | 152 | 152 | |||
Directors' common stock compensation | 4 | ||||
Balance at Jun. 30, 2023 | $ 22 | $ 2,374 | 2,227,802 | (1,739,334) | 490,842 |
Balance (in shares) at Jun. 30, 2023 | 248,712 | ||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Issuance of Series A Preferred Stock in exchange for common stock | $ (218) | 218 | |||
Issuance of Series A Preferred Stock in exchange for common stock (in shares) | 22 | ||||
Net loss | 30,748 | 30,748 | |||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | $ 61 | 32,105 | 32,166 | ||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan (in shares) | 6,136 | ||||
Issuance of common stock, net of issuance costs | (34) | (34) | |||
Issuance of common stock pursuant to pre-funded warrant exchange | 10,992 | ||||
Stock option and restricted stock compensation expense | 7,807 | 7,807 | |||
Directors' deferred share unit compensation | 67 | 67 | |||
Directors' common stock compensation | 2 | ||||
Balance at Sep. 30, 2023 | $ 22 | $ 2,435 | $ 2,267,747 | $ (1,708,586) | $ 561,596 |
Balance (in shares) at Sep. 30, 2023 | 265,842 | 265,842 | |||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||
Issuance of Series A Preferred Stock in exchange for common stock | |||||
Issuance of Series A Preferred Stock in exchange for common stock (in shares) | 22 |
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 loss | $ (14,514) | $ (163,921) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Non-cash royalty revenue related to sale of future royalties | (8,494) | (9,027) |
Non-cash interest expense on liability related to sale of future royalties and convertible senior notes | 2,691 | 3,194 |
Non-cash interest expense on amortization of debt discount and issuance costs | 295 | |
Depreciation and amortization | 1,298 | 1,355 |
Stock and deferred share unit compensation | 22,374 | 14,862 |
Change in operating assets and liabilities: | ||
Accounts receivable | (118,098) | 4,425 |
Unbilled receivable | (1,495) | 1,649 |
Inventory | (17,572) | |
Contract asset | 3,000 | |
Prepaid and other current assets | (7,707) | (9,392) |
Operating lease right-of-use assets | 1,893 | 1,583 |
Other assets | (148) | (4,389) |
Accounts payable | (20,395) | 1,689 |
Accrued compensation | 4,044 | 3,152 |
Other accrued liabilities | 7,472 | 23,057 |
Deferred revenue | 13,693 | (38,257) |
Operating lease liability | (3,027) | (2,583) |
Net cash used for operating activities | (137,690) | (169,603) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (1,641) | (1,116) |
Net cash used for investing activities | (1,641) | (1,116) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock under stock plans | 47,111 | 1,480 |
Proceeds from term loan, net of $3,182 of issuance costs | 71,818 | |
Proceeds from common stock issuance, net of $526 of transaction costs | 350,799 | |
Net cash provided by financing activities | 469,728 | 1,480 |
Net change in cash and cash equivalents | 330,397 | (169,239) |
Cash and cash equivalents, beginning of period | 275,138 | 478,750 |
Cash and cash equivalents, end of period | 605,535 | $ 309,511 |
Supplemental cash flow information: | ||
Cash paid during the year for interest | 4,857 | |
Cash paid during the year for taxes | $ 1,361 |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Term loan issuance costs | $ 3,182 |
Common Stock | |
Common stock issuance transaction costs | $ 526 |
Nature of Business and Plan of
Nature of Business and Plan of Operations | 9 Months Ended |
Sep. 30, 2023 | |
Nature of Business and Plan of Operations | |
Nature of Business and Plan of Operations | IMMUNOGEN, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS September 30, 2023 A. Nature of Business and Plan of Operations ImmunoGen, Inc. (the Company) was incorporated in Massachusetts in 1981 and is focused on the development and commercialization of antibody-drug conjugates (ADCs). On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval for ELAHERE ® The Company has generally incurred operating losses and negative cash flows from operations since inception, incurred a net loss of $14.5 million during the nine months ended September 30, 2023, and had an accumulated deficit of approximately $1.7 billion as of September 30, 2023. To date, the Company has funded these losses through payments received from its collaborations, equity, convertible debt, and other financings, such as royalty financing transactions and a term loan facility, and, more recently, through At September 30, 2023, the Company had $605.5 million of cash and cash equivalents on hand. The Company currently believes that its existing capital resources will be sufficient to fund its operating expenses and capital expenditures for more than twelve months after the date these financial statements were issued. The Company expects to generate additional funds through a combination of commercial sales of ELAHERE and revenues from collaborations, including upfront license payments, milestone payments, royalty payments, and research funding, to support its planned operating activities ; however, The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, the development by its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, manufacturing and marketing limitations, challenges entering into new collaborations, complexities associated with managing collaboration arrangements, third-party reimbursements, and compliance with governmental regulations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation and Significant Accounting Policies | B. Basis of Presentation and Significant Accounting Policies Basis of Presentation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated. The consolidated financial statements include all of the adjustments, consisting only of normal recurring adjustments, which management considers necessary for a fair presentation of the Company’s financial position in accordance with accounting principles generally accepted in the U.S. for interim financial information. The December 31, 2022 consolidated balance sheet presented for comparative purposes was derived from the Company’s audited financial statements, and certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. The preparation of interim financial statements requires the use of management’s estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements and the reported amounts of revenues and expenditures during the reported periods. The results of the interim periods are not necessarily indicative of the results for the entire year. Accordingly, the interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023. Significant Accounting Policies There were no changes to significant accounting policies used in preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2023, from those discussed in Note B to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Revenue Recognition Transaction Price Allocated to Future Performance Obligations Deferred revenue under Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC), Revenue from Contracts with Customers 13 61 ® Contract Balances from Contracts with Customers The following tables present changes in the Company’s contract assets and contract liabilities during the nine months ended September 30, 2023 and 2022 (in thousands): Balance at Balance at December 31, 2022 Additions Deductions Impact of Netting September 30, 2023 Contract liabilities (deferred revenue) $ 50,211 $ 23,227 $ (9,534) $ — $ 63,904 Balance at Balance at December 31, 2021 Additions Deductions Impact of Netting September 30, 2022 Contract asset $ 3,000 $ — $ (3,000) $ — $ — Contract liabilities (deferred revenue) $ 92,068 $ 5,704 $ (43,961) $ — $ 53,811 The Company recognized the following revenues as a result of changes in contract asset and contract liability balances in the respective periods (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Revenue recognized in the period from: Amounts included in contract liabilities at the beginning of the period $ 3,929 $ 7,337 $ 9,534 $ 43,961 The timing of revenue recognition, billings, and cash collections results in billed receivables, unbilled receivables, contract assets, and contract liabilities on the consolidated balance sheets. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded (under the caption deferred revenue). Contract liabilities are recognized as revenue after control of the products or services is transferred to the customer and all revenue recognition criteria have been met. During the nine months ended September 30, 2023, a $23.2 million upfront payment received pursuant to a collaboration and license agreement with Takeda Pharmaceutical Company Limited (Takeda) was recorded as deferred revenue and none of this amount was recognized as revenue during the nine months ended September 30, 2023. Additionally, the Company received an upfront payment of $15.0 million pursuant to a multi-target license and option agreement executed with Vertex Pharmaceuticals Incorporated (Vertex) which was recorded as license and milestone fee revenue in the nine months ended September 30, 2023. Further details of these agreements can be found in Note C, “Collaboration and License Agreements.” During the nine months ended September 30, 2023, the Company also recognized $9.4 million of previously deferred non-cash royalty revenue related to the sale of rights to KADCYLA During the nine months ended September 30, 2022, pursuant to the Company’s license agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Huadong), upon delivery of clinical materials in the nine months ended September 30, 2022, the Company recognized as license and milestone fee revenue the remaining $28.5 million of the deferred revenue balance as of December 31, 2021, related to the $45.0 million of upfront and development milestone payments previously received. Additionally, pursuant to a license agreement executed with Eli Lilly and Company (Lilly), during the nine months ended September 30, 2022, the Company received upfront payments of $19.5 million, of which $13.8 million was recognized as license and milestone fee revenue and the remainder deferred. The Company also recognized $12.5 million of previously deferred non-cash royalty revenue related to the sale of rights to KADCYLA $2.9 million of license and milestone fee revenue related to numerous collaborators’ rights to technological improvements that had been previously deferred, which includes $2.8 million related to Novartis Institutes for BioMedical Research, Inc.’s (Novartis) termination of certain of the license agreements between the Company and Novartis in August 2022. Financial Instruments and Concentration of Credit Risk Cash and cash equivalents are primarily maintained with three financial institutions in the U.S. Deposits with banks may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, the Company does not believe it is exposed to significant risk. The Company’s cash equivalents consist of money market funds with underlying investments primarily being U.S. Government-issued securities and high quality, short-term commercial paper. Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, and marketable securities. The Company held no marketable securities as of September 30, 2023 and December 31, 2022. The Company’s investment policy, approved by the Board of Directors, limits the amount it may invest in any one type of investment, thereby reducing credit risk concentrations. Cash and Cash Equivalents The Company considers all highly liquid financial instruments with maturities of three months or less when purchased to be cash equivalents. As of September 30, 2023 and December 31, 2022, the Company held $605.5 million and $275.1 million, respectively, in cash and money market funds, which were classified as cash and cash equivalents. Non-cash Investing and Financing Activities The Company had $0.3 million of accrued capital expenditures as of December 31, 2022, which has been treated as a non-cash investing activity and, accordingly, is not reflected in the consolidated statement of cash flows. There were no accrued capital expenditures as of September 30, 2023. Fair Value of Financial Instruments Fair value is defined under ASC 820, Fair Value Measurements and Disclosures ● Level 1 - Quoted prices in active markets for identical assets or liabilities. ● Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. As of September 30, 2023 and December 31, 2022, the Company held certain assets that are required to be measured at fair value on a recurring basis. The fair value of the Company’s cash equivalents is based on quoted prices from active markets (Level 1 inputs). The carrying amounts reflected in the consolidated balance sheets for accounts receivable, unbilled receivables, non-cash royalty receivable, prepaid and other current assets, accounts payable, accrued compensation, and other accrued liabilities approximate fair value due to their short-term nature. As of September 30, 2023, the estimated fair value and gross carrying amount of the term loan was $79.7 million and $75.0 million, respectively. The Company’s disclosed fair value of the term loan falls into the Level 2 category within the fair value level hierarchy and the fair value was determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability (other than quoted prices), such as interest rates that are observable at commonly quoted intervals. Accounts Receivable Accounts receivable arise from product sales and amounts due from the Company’s collaboration partners. The amount from product sales represents amounts due from specialty distributors and specialty pharmacy providers in the U.S. The Company monitors economic conditions and the financial performance and credit worthiness of its counterparties to identify facts or circumstances that may indicate that its receivables are at risk of collection. The Company provides reserves against accounts receivable for estimated losses that may result from a customer’s inability to pay based on the composition of its accounts receivable, considering past events, current economic conditions, and reasonable and supportable forecasts about the future economic conditions. The contractual life of accounts receivable is generally short-term. Amounts determined to be uncollectible are charged or written off against the reserve. For the three and nine months ended September 30, 2023 and 2022, the Company did not record any expected credit losses related to outstanding accounts receivable. Inventory Inventories are stated at the lower of cost or estimated net realizable value with cost based on the first-in first-out method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials. The Company classifies its inventory costs as long-term when it expects to utilize the inventory beyond its normal operating cycle based on forecasted levels of sales. Prior to the regulatory approval of its drug candidates, the Company incurs expenses for the manufacture of drug product to support clinical development that could potentially be available to support the commercial launch of those drugs. Until the date at which regulatory approval has been received or is otherwise considered probable, the Company records all such costs as research and development expenses. The Company performs an assessment of the recoverability of capitalized inventories during each reporting period and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded as a component of cost of sales in the consolidated statements of operations and comprehensive loss. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. There were no expenses recorded for excess inventory or other impairments during the three and nine months ended September 30, 2023. There was no inventory held by the Company during the three and nine months ended September 30, 2022. Debt issuance costs and debt discount Debt issuance costs and debt discounts are presented on the accompanying consolidated balance sheets as a direct reduction from the carrying value of the debt and are amortized to interest expense over the term of the related debt using the effective interest method. See Note G, “Senior Secured Term Loan” for further discussion related to long-term debt. Computation of Net Loss per Common Share Basic and diluted net loss per share is calculated based upon the weighted average number of shares of common stock outstanding during the period. Shares of the Company’s common stock, par value $.01 per share, underlying pre-funded warrants are included in the calculation of basic and diluted earnings per share. Shares of the Company’s Series A Convertible Preferred Stock participate in any dividends that may be declared by the Company and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of income, participating securities are allocated a proportional share of income determined by dividing total weighted-average participating securities by the sum of the total weighted average common shares and participating securities (the two-class method). During periods of loss, no loss is allocated to participating securities since they have no contractual obligation to share in the losses of the Company. Diluted loss per share is computed after giving consideration to the dilutive effect of stock options and restricted stock units that are outstanding during the period, except where such non-participating securities would be antidilutive. The dilutive effect of participating securities is calculated using the more dilutive of either (i) the treasury stock method (for stock options and restricted stock units) and “if-converted” method (for Series A Convertible Preferred Stock) or (ii) the two-class method assuming the Series A Convertible Preferred Stock is not converted and applying the treasury stock method (for stock options and restricted stock units). The following table sets forth the computation of basic and diluted earnings per share for the three months ended September 30, 2023. There was a net loss in all other periods presented, and as such, no loss was allocated to participating securities pursuant to the two class method for those periods. Three Months Ended September 30, 2023 Numerator: Net income $ 30,748 Allocation of earnings to participating securities (2,276) Numerator for basic EPS — income available to common stockholders (A) $ 28,472 Effect of dilutive securities: Add back allocation of earnings to participating securities $ 2,276 Reallocation of earnings to participating securities considering potentially dilutive securities (2,171) Numerator for diluted EPS — income available to common stockholders (C) $ 28,577 Denominator: Denominator for basic EPS — weighted average shares (B) 273,341 Effect of dilutive securities: Common stock equivalents 14,249 Denominator for diluted EPS — adjusted weighted average shares (D) 287,590 Basic EPS (A / B) $ 0.10 Diluted EPS (C / D) $ 0.10 The Company’s common stock equivalents, as calculated in accordance with the treasury-stock method for options and unvested restricted stock units and the if-converted method for the Series A Convertible Preferred Stock, are shown in the following table (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Options outstanding to purchase common stock, shares issuable under the employee stock purchase plan, and unvested restricted stock units at end of period 29,927 31,479 29,927 31,479 Common stock equivalents under treasury stock method for options, shares issuable under the employee stock purchase plan, and unvested restricted stock units 14,249 2,246 10,671 1,437 Common stock equivalents under if-converted method for Series A Convertible Preferred Stock 21,853 — 21,853 — Stock-Based Compensation As of September 30, 2023, the Company was authorized to grant future awards under three employee share-based compensation plans, which are the ImmunoGen, Inc. Amended and Restated 2018 Employee, Director and Consultant Equity Incentive Plan (the 2018 Plan), the Employee Stock Purchase Plan (the ESPP), and the ImmunoGen Inducement Equity Incentive Plan (the Inducement Plan). At the annual meeting of shareholders on June 15, 2022, the 2018 Plan was amended to provide for the issuance of stock grants, the grant of options, and the grant of stock-based awards for up to an additional 13,000,000 shares of the Company’s common stock, as well as up to 28,742,013 shares of common stock, which represent the number of shares of common stock remaining under the 2018 Plan as of April 1, 2022, and awards previously granted under the 2018 Plan and the Company’s former stock-based plans, including the ImmunoGen, Inc. 2016 and 2006 Employee, Director and Consultant Equity Incentive Plans, that forfeit, expire, or cancel without delivery of shares of common stock or which resulted in the forfeiture of shares of common stock back to the Company subsequent to April 1, 2022. The Inducement Plan was approved by the Board of Directors in December 2019, and pursuant to subsequent amendments, provides for the issuance of non-qualified option grants for up to 13,500,000 shares of the Company’s common stock. Options awarded under the two plans are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Options vest at various periods of up to four years and may be exercised within ten years of the date of grant under each of these plans. The stock-based awards are accounted for under ASC 718, Compensation—Stock Compensation Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Dividend None None None None Volatility 88.4% 83.3% 83.4% 83.2% Risk-free interest rate 4.52% 3.44% 3.78% 2.48% Expected life (years) 5.6 5.6 5.7 5.9 Using the Black-Scholes option-pricing model, the weighted-average grant date fair values of options granted during the three months ended September 30, 2023 and 2022 were $11.52 and $3.62 per share, respectively, and $4.85 and $3.58 for options granted during the nine months ended September 30, 2023 and 2022, respectively. A summary of option activity under the Company’s equity plans for the nine months ended September 30, 2023 is presented below (in thousands, except weighted-average data): Weighted- Number Average of Stock Exercise Options Price Outstanding at December 31, 2022 33,126 $ 5.76 Granted 6,316 6.71 Exercised (9,121) 5.05 Forfeited/Canceled (2,653) 6.30 Outstanding at September 30, 2023 27,668 $ 6.15 In 2020, the Company issued 2.6 million performance-based stock options to certain employees with vesting conditioned upon the achievement of specified performance goals. In 2022, 75% of the 2.6 million performance-based stock options vested upon achievement of specified performance goals and 12.5% were forfeited. There was no stock-based compensation recorded during the three or nine months ended September 30, 2023 related to these stock options. The fair value of the remaining unvested performance-based stock options that could be expensed in future periods is $1.3 million. A summary of restricted stock unit activity under the Company’s equity plans for the nine months ended September 30, 2023 is presented below (in thousands, except weighted-average data): Number of Weighted- Restricted Average Grant Stock Shares Date Fair Value Unvested at December 31, 2022 138 $ 5.45 Granted 2,380 6.32 Forfeited (259) 4.66 Unvested at September 30, 2023 2,259 $ 7.11 In June 2018, the Company's Board of Directors, with shareholder approval, adopted the Employee Stock Purchase Plan (ESPP). Following the automatic share increase on January 1, 2021, pursuant to the ESPP’s “evergreen” provision, an aggregate of 2,000,000 shares of common stock have been reserved for issuance under the ESPP. ESPP purchase periods are six months and begin on January 1 and July 1 of each year, with purchase dates occurring on the final business day of the given purchase period. The fair value of each ESPP award is estimated on the first day of the offering period using the Black-Scholes option-pricing model. The Company recognizes share-based compensation expense equal to the fair value of the ESPP awards on a straight-line basis over the offering period. Stock compensation expense related to stock options and restricted stock unit awards granted under the stock plans and the ESPP was $7.8 million and $22.0 million during the three and nine months ended September 30, 2023, respectively, compared to $5.3 million and $14.3 million for the three and nine months ended September 30, 2022, respectively. The increase in stock compensation expense is primarily due to significant growth in personnel in the second half of 2022. As of September 30, 2023, the estimated fair value of unvested employee awards was $72.0 million. The weighted-average remaining vesting period for these awards is approximately three years. Segment Information During all periods presented, the Company continued to operate in one reportable business segment under the management approach of ASC 280, Segment Reporting During the three months ended September 30, 2023, 93% of revenues were generated from net U.S. sales of ELAHERE to four specialty distributors and specialty pharmacy providers, and 7% of revenues were generated from an agreement with Roche, compared to 52%, 30% and 18% of revenues from Roche, Lilly and Novartis, respectively, during the three months ended September 30, 2022. During the nine months ended September 30, 2023, 86% of revenues were generated from net U.S. sales of ELAHERE to four specialty distributors and specialty pharmacy providers, and 7% and 6% of revenues were generated from agreements with Roche and Vertex, respectively, compared to 43%, 32% and 20% from agreements with Huadong, Roche, and Lilly, respectively, during the nine months ended September 30, 2022. There were no other customers of the Company that generated significant revenues in the three and nine months ended September 30, 2023 and 2022. Recently Adopted Accounting Pronouncements There were no recently issued or effective FASB Accounting Standards Updates (ASUs) that had, or are expected to have, a material effect on the Company's results of operations, financial condition, or liquidity. |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Collaboration and License Agreements | |
Collaboration and License Agreements | C. Collaboration and License Agreements The Company has numerous collaboration and license agreements with third parties. These agreements typically provide the licensee with rights to use the Company’s ADC platform technology with the licensee’s antibodies or related targeting vehicles to a defined target to develop products. The licensee is generally responsible for the development, clinical testing, manufacturing, registration, and commercialization of any resulting product candidate. As part of these agreements, the Company is generally entitled to receive upfront fees, potential milestone payments, royalties on the sales of any resulting products, and research and development funding based on activities performed at our collaborative partner’s request. See below for details regarding the Company’s collaboration and license agreements with activity in the financial statement periods presented. Takeda On August 25, 2023, the Company entered into a collaboration and license agreement with Takeda. The collaboration and license agreement grants Takeda an exclusive, royalty-bearing right to develop and commercialize ELAHERE (mirvetuximab soravtansine-gynx) (the Licensed Product) in Japan. Under the terms of the collaboration and license agreement, the Company received a non-refundable upfront payment of $23.2 million, with the potential for up to ¥19.9 billion ( The Company evaluated the agreement and determined it was within the scope of ASC 606. The Company determined the promised goods and services included the license to intellectual property and know-how and the clinical supply of the Licensed Product to Takeda for a specified period. The Company concluded that the license to intellectual property and know-how is not distinct from the clinical supply of the Licensed Product because the clinical supply is essential to the use of the license and an alternative source of clinical supply is not readily available in the marketplace. Accordingly, these two promised goods and services are considered a single combined performance obligation. The Company determined there were no options in the agreement that represented material rights. The transaction price was determined to consist of the upfront payment of $23.2 million and estimated payments to be received for clinical supply of the Licensed Product. Future regulatory milestones have been fully constrained. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license granted to Takeda. The Company re-evaluates the transaction price, including its estimated variable consideration included in the transaction price and all constrained amounts, at each reporting period and as uncertain events are resolved or other changes in circumstances occur. The Company determined that revenue related to the agreement would be recognized as the clinical supply of the Licensed Product is delivered to Takeda, estimated to be completed over approximately 1.5 years. The Company has estimated the total clinical supply to be delivered during this time and will reassess the percentage of clinical supply that has been delivered on an ongoing basis. If a change in estimate is determined to be necessary, the Company will adjust revenue using a cumulative catch-up method. No revenue related to this agreement has been recognized in the three months ended September 30, 2023. Vertex (each, an Option and, collectively, the Options) before the end of the research term In addition, upon exercise of each Option by Vertex, the Company will be eligible to receive up to approximately $337.0 million per target in potential option exercise fees and milestone payments based on the achievement of pre-specified development, regulatory, and sales-based milestones. With respect to each target that Vertex exercises an Option, the Company will also be eligible to receive tiered royalties, on a product-by-product basis, as a percentage of worldwide annual net sales by Vertex, its affiliates and sublicensees, based on certain net sales thresholds. Vertex is responsible for all costs related to the research and development of the compounds during the research term and commercialization of any ensuing products. The Company evaluated the agreement and determined it was within the scope of ASC 606. The Company determined the promised goods and services included a license to use the Company’s intellectual property and know-how to research, manufacture, and evaluate products related to each of the initial research targets selected by Vertex during the research term. The Company determined that the agreement has a single performance obligation for these promised goods and services. The Options to obtain exclusive development and commercialization licenses and the right to select additional research targets during the research term do not represent a material right as the fees associated with each option are at or above the standalone selling price. Accordingly, upon exercise, these Options will be accounted for as a separate arrangement. The transaction price related to the single performance obligation was determined to consist of the upfront payment of $15.0 million. The transfer of intellectual property and know-how to Vertex to allow Vertex to derive benefit from the license over the research term was completed during the three months ended March 31, 2023. As such, the Company’s performance obligation was satisfied, and the Company recognized $15.0 million of license and milestone fee revenue during the nine months ended September 30, 2023. Lilly In February 2022, the Company entered into a license agreement with Lilly, pursuant to which the Company granted Lilly worldwide exclusive rights to research, develop, and commercialize antibody-drug conjugates based on the Company’s novel camptothecin technology. Under the terms of the license agreement, the Company received a non-refundable upfront payment of $13.0 million, reflecting initial targets selected by Lilly. During 2022, pursuant to the terms of the agreement, Lilly selected additional targets for which the Company received an additional $13.0 million in non-refundable payments. The transfer of intellectual property and know-how to Lilly to allow for Lilly to derive benefit from the initial and additional target licenses was completed during the three months ended March 31, 2022. As such, during 2022 the Company recognized $18.4 million of license and milestone fee revenue related to the portion of the transaction price allocated to the initial and additional target licenses, of which $13.8 million was recorded during the nine months ended September 30, 2022. The $7.6 million allocated to the material rights to obtain licenses to replacement targets is included in long-term deferred revenue as of September 30, 2023 and will be recognized when the right is either exercised or expires. Huadong In October 2020, the Company entered into a collaboration and license agreement with Huadong. The collaboration and license agreement grants Huadong an exclusive, royalty-bearing, and sublicensable right to develop and commercialize ELAHERE (the Licensed Product) in the People’s Republic of China, Hong Kong, Macau, and Taiwan (collectively, Greater China). The Company retains exclusive rights to the Licensed Product outside of Greater China. Under the terms of the collaboration and license agreement, the Company received a non-refundable upfront payment of $40.0 million with the potential for approximately $265.0 million in development, regulatory, and sales-based milestone payments. In addition, the Company is entitled to receive tiered royalties ranging from low double digits to high teens as a percentage of commercial net sales of the licensed product, if approved, by Huadong in Greater China, subject to adjustment in specified circumstances. To date, the Company has received $15.0 million in milestone payments. The Company determined that revenue related to the agreement would be recognized as the clinical supply of the Licensed Product is delivered to Huadong, estimated to be completed over approximately two years . Accordingly, based on clinical supply delivered to Huadong during the nine months ended September 30, 2022, the Company recorded the remaining $28.5 million of deferred revenue as of December 31, 2021 related to $45.0 million of upfront and development milestone payments previously received. Roche In 2000, the Company granted Genentech, now a unit of Roche, an exclusive development and commercialization license to use the Company’s maytansinoid ADC technology. Pursuant to this agreement, Roche developed and received marketing approval for its HER2-targeting ADC, KADCYLA, in the U.S., Japan, the European Union, and numerous other countries. In accordance with the Company’s revenue recognition policy, $17.9 million and $21.5 million of non-cash royalties on net sales of KADCYLA were recognized and included in non-cash royalty revenue for the nine months ended September 30, 2023 and 2022, respectively. The Company sold its rights to receive royalty payments on the net sales of KADCYLA through two separate transactions in 2015 and 2019. Following the 2019 transaction, OMERS, the defined benefit pension plan for municipal employees in the Province of Ontario, Canada, is entitled to receive all of these royalties. Novartis The Company previously granted Novartis exclusive development and commercialization licenses to the Company’s maytansinoid and IGN ADC technology for use with antibodies to specified targets under a now-expired right-to-test agreement established in 2010. In August 2022, Novartis terminated certain of the remaining development and commercialization licenses. The Company had $2.8 million of deferred revenue associated with the terminated licenses related to the portion of the transaction price previously allocated to rights to future technological improvements. In consideration that no technological improvements would be provided to Novartis and, therefore, no unsatisfied obligations remained related to such licenses, the $2.8 million was recorded as revenue and is included in license and milestone fees for the three and nine months ended September 30, 2022. With respect to the remaining license, $0.7 million of deferred revenue related to the portion of the transaction price previously allocated to rights to future technological improvements continues to be amortized over the remaining estimated term of the license agreement, and we are entitled to receive up to a total of $199.5 million in potential milestone payments, of which $5 million has been received to date, plus royalties on the commercial sales of any resulting products. For additional information related to these agreements, as well as the Company’s other collaboration and license agreements, please read Note C, “Collaboration and License Agreements,” to the audited financial statements included within the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023. |
Product Revenue Reserves and Al
Product Revenue Reserves and Allowances | 9 Months Ended |
Sep. 30, 2023 | |
Product Revenue Reserves and Allowances | |
Product Revenue Reserves and Allowances | D. Product Revenue Reserves and Allowances In November 2022, the FDA granted accelerated approval for ELAHERE for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The Company recorded net product revenue of $105.2 million and $212.1 million from U.S. sales of ELAHERE during the three and nine months ended September 30, 2023, respectively. The following table summarizes activity in each of the product revenue reserve and allowance categories as of September 30, 2023 and 2022, respectively. (in thousands): September 30, September 30, 2023 2022 Beginning balance at January 1 $ 313 $ — Provision related to sales in the current period 36,012 — Credits and payments made (28,223) — Ending balance at September 30 $ 8,102 $ — |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2023 | |
Inventory | |
Inventory | E. Inventory Capitalized inventory consists of the following at September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, 2023 2022 Raw materials $ 28,555 $ 15,952 Work in process 2,839 — Finished goods 2,374 244 Total inventory $ 33,768 $ 16,196 |
Liability Related to Sale of Fu
Liability Related to Sale of Future Royalties | 9 Months Ended |
Sep. 30, 2023 | |
Liability Related to Sale of Future Royalties | |
Liability Related to Sale of Future Royalties | F. Liability Related to Sale of Future Royalties In 2015, Immunity Royalty Holdings, L.P. (IRH) purchased the right to receive 100% of the royalty payments on commercial sales of KADCYLA arising under the Company’s development and commercialization license with Genentech, until IRH had received aggregate royalties equal to $235.0 million or $260.0 million, depending on when the aggregate royalties received by IRH reached a specified milestone. Once the applicable threshold was met, the Company would thereafter have received 85% and IRH would have received 15% of the KADCYLA royalties for the remaining royalty term. At consummation of the transaction, the Company received cash proceeds of $200.0 million. As part of this sale, the Company incurred $5.9 million of transaction costs, which are presented net of the liability in the accompanying consolidated balance sheet and are being amortized to interest expense over the estimated life of the royalty purchase agreement. Although the Company sold its rights to receive royalties from the sales of KADCYLA, as a result of its ongoing involvement in the cash flows related to these royalties, the Company continues to account for these royalties as revenue and recorded the $200.0 million in proceeds from this transaction as a liability related to sale of future royalties (Royalty Obligation) that is being amortized using the interest method over the estimated life of the royalty purchase agreement. In January 2019, the Company sold its residual rights to receive royalty payments on commercial sales of KADCYLA to OMERS for a payment of $65.2 million (amount is net of $1.5 million in broker fees). Simultaneously, OMERS purchased IRH’s right to the royalties the Company previously sold to IRH as described above, therefore obtaining the rights to 100% of the royalties received from that date on. Because the Company will not be involved with the cash flows related to the residual royalties, the $65.2 million of net proceeds received from the sale of its residual rights to receive royalty payments was recorded as deferred revenue and is being amortized as the royalty revenue related to the residual rights is earned using the units of revenue approach. During the second quarter of 2021, the aggregate royalty threshold was met and, in accordance with the Company’s revenue recognition policy, $9.4 million and $12.5 million of revenue related to the residual rights was recorded and is included in non-cash royalty revenue for the nine months ended September 30, 2023 and 2022, respectively. Additionally, the purchase of IRH’s interest by OMERS did not result in an extinguishment or modification of the original instrument and, accordingly, the Company continues to account for the remaining obligation as a liability as outlined above. The following table shows the activity within the liability account during the nine-month period ended September 30, 2023 (in thousands): Nine Months Ended September 30, 2023 Liability related to sale of future royalties, net — beginning balance $ 32,108 Proceeds from sale of future royalties, net — KADCYLA royalty payments received and paid (8,907) Non-cash interest expense recognized 2,691 Liability related to sale of future royalties, net — ending balance $ 25,892 The Company receives royalty reports and royalty payments related to sales of KADCYLA from Roche one |
Debt, Long-Term
Debt, Long-Term | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt, Long-Term | G. Senior Secured Term Loan Net proceeds from the initial tranche of the term loan, after deducting the lenders fees and transaction costs of $3.2 million, were $71.8 million. The loan agreement permits voluntary prepayment at any time, subject to a prepayment premium. The loan agreement also includes a make-whole premium in the event of a voluntary prepayment, a prepayment due to a change in control or acceleration following an Event of Default (as defined in the loan agreement) on or prior to the three-year anniversary of the closing date, in each case in an amount equal to foregone interest from the date of prepayment through the three-year anniversary of the closing date. A change of control also triggers a mandatory prepayment of the term loan. The loan agreement contains affirmative and negative covenants customary for transactions of this type and includes certain customary events of default. The Company was in compliance with all such covenants at September 30, 2023. The term loan is secured by a perfected security interest on substantially all of the Company’s assets, excluding certain products and related intellectual property and contracts that are not related to ELAHERE. The Company assessed all terms and features of the loan agreement in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the loan agreement, including put and call features. The Company determined that all features of the loan agreement were either clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's financial statements. The Company reassesses the features on a quarterly basis to determine if they require separate accounting. The following table presents the carrying value of the Company’s term loan balance as of September 30, 2023 (in thousands): September 30, 2023 Principal loan balance $ 75,000 Debt discount and issuance costs, unamortized (2,887) Term loan, net $ 72,113 During the three and nine months ended September 30, 2023, the Company recognized interest expense related to the term loan of $2.5 million and $4.9 million, respectively. Additionally, given the Company’s current capital and expected sales of ELAHERE, the Company determined the likelihood of drawing the second tranche of $50.0 million to be remote, and as such, recorded a $1.0 million facility fee that is owed to the lender regardless of whether the additional funding is drawn as interest expense for the nine months ended September 30, 2023. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Taxes | |
Income Taxes | H. Income Taxes The liability method is used in the Company’s accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse . The realization of deferred income tax assets is dependent on the generation of sufficient taxable income during future periods in which temporary differences are expected to reverse. Where the realization of such assets does not meet the more likely than not criterion, the Company applies a valuation allowance against the deferred income tax asset under consideration. The valuation allowance is reviewed periodically and if the assessment of the more likely than not criterion changes, the valuation allowance is adjusted accordingly. As of September 30, 2023, the Company has a full valuation allowance applied against its deferred tax assets. As part of the Tax Cuts and Jobs Act of 2017 (2017 Tax Act), beginning with the 2022 tax year, the Company is required to capitalize research and development expenses, as defined under Internal Revenue Code Section 174. For expenses that are incurred for research and development in the U.S., the amounts will be amortized over five years, and expenses that are incurred for research and experimentation outside the U.S. will be amortized over 15 years. Pursuant to additional Section 174 guidance issued by the Internal Revenue Service prior to finalizing the Company’s 2022 tax return but subsequent to the Company preparing its 2022 year-end tax provision, the Company recorded a $1.2 million favorable tax adjustment during the three months ended September 30, 2023. Partially offsetting this benefit, during the nine months ended September 30, 2023, the Company recorded income tax expense of $0.8 million as a provision for calendar 2023. |
Capital Stock
Capital Stock | 9 Months Ended |
Sep. 30, 2023 | |
Capital Stock | |
Capital Stock | I. Capital Stock Pre-Funded Warrants Pursuant to transactions completed in 2021, the Company issued pre-funded warrants to purchase up to an aggregate of 21,434,782 and 11,363,636 shares of the Company’s common stock to RA Capital Healthcare Fund, L.P. (RA Capital) Related Party Disclosures The pre-funded warrants’ fundamental transaction provision does not provide the warrant holders with the option to settle any unexercised warrants for cash in the event of any fundamental transactions; rather, in all fundamental transaction scenarios, the warrant holder will only be entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion) that is being offered and paid to the shareholders of the Company in connection with the fundamental transaction, whether that consideration be in the form of cash, stock, or any combination thereof. The pre-funded warrants also include a separate provision whereby the exercisability of the warrants may be limited if, upon exercise, the warrant holder or any of its affiliates would beneficially own more than 9.99% of the Company’s common stock. This threshold is subject to the holder’s rights under the pre-funded warrants to increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from the holder to the Company. The Company assessed the pre-funded warrants for appropriate equity or liability classification pursuant to the Company’s accounting policy described in Note B, “Summary of Significant Accounting Policies.” During this assessment, the Company determined the pre-funded warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815. The pre-funded warrants are indexed to the Company’s common stock and meet all other conditions for equity classification under ASC 480 and ASC 815. Based on the results of this assessment, the Company concluded that the pre-funded warrants are freestanding equity-linked financial instruments that meet the criteria for equity classification under ASC 480 and ASC 815. Accordingly, the pre-funded warrants were classified as equity and accounted for as a component of additional paid-in capital at the time of issuance and at each subsequent balance sheet date. The Company also determined that the pre-funded warrants should be included in the determination of basic and diluted earnings per share in accordance with ASC 260, Earnings per Share During the nine months ended September 30, 2023, Redmile completed a cashless exercise in full of its outstanding pre-funded warrant to purchase 11,357,272 shares of the Company’s common stock and RA Capital exercised 11,000,000 of its 21,434,872 pre-funded warrants outstanding, resulting in the issuance of 10,992,330 shares of the Company’s common stock. Series A Convertible Preferred Stock On May 1, 2023, the Company entered into an exchange agreement with RA Capital Each share of the Series A Preferred Stock is convertible into 1,000 shares of the Company’s common stock at the option of the holder at any time until the tenth anniversary of the issuance of the Series A Preferred Stock, at which time the Series A Preferred Stock will automatically convert to the Company’s common stock In addition, the Company has the right to request the conversion of the Series A Preferred Stock into the Company’s common stock in certain circumstances. The conversion of the Series A Preferred Stock into common stock is Shares of Series A Preferred Stock will have no voting rights, except as required by law and except that the affirmative vote of the holders of the then outstanding Series A Preferred Stock will be required to amend the terms of the Series A Preferred Stock, increase the number of authorized shares of Series A Preferred Stock, or enter into an agreement with respect to any of the foregoing The holders of the Series A Preferred Stock are entitled to receive a nominal preference of $0.001 per share of Series A Preferred Stock upon the liquidation, dissolution, or winding up of the Company (the Liquidation Preference) before any payments are made or any assets are distributed to holders of the Company’s common stock. However, if the amount payable to holders of the Company’s common stock upon the Company’s liquidation, dissolution, or winding up is greater than the Liquidation Preference on a per share basis, then the holders of the Series A Preferred Stock will instead receive, on a per-share and as-converted basis, the same assets that are distributed to holders of the Company’s common stock. In the event of certain fundamental transactions, including a merger, holders of the Series A Preferred Stock will automatically receive, as consideration for the Series A Preferred Stock, the same kind and amount of securities, cash, or property as the holders of the Series A Preferred Stock would have been entitled to receive had the holders of the Series A Preferred Stock instead held the Company’s common stock immediately prior to the occurrence of the fundamental transaction, subject to certain exceptions. The Company evaluated the Series A Preferred Stock for liability or equity classification under ASC 480, “ ,” and determined that equity treatment was appropriate because the Preferred Stock did not meet the definition of a liability under ASC 480. The Series A Preferred Stock is not redeemable for cash or other assets on a fixed or determinable date or at the option of the holder. Additionally, as noted above, upon the liquidation of the Company or in the event of a fundamental transaction, such as a merger or acquisition, the holders of the Series A Preferred Stock will receive the same assets that are distributed to the holders of the Company’s common stock. As such, the Company recorded the Series A Preferred Stock as permanent equity. Compensation Policy for Non-Employee Directors Pursuant to the Compensation Policy for Non-Employee Directors, as amended, non-employee directors are granted restricted stock units (RSUs) upon initial election to the Board of Directors and annually thereafter. Initial and annual RSUs vest annually over approximately three years and one year from the date of grant, respectively, contingent upon the individual remaining a director of ImmunoGen as of each vesting date. The number of RSUs awarded is fixed per the policy on the date of the award. All unvested RSUs will automatically vest immediately prior to the occurrence of a change of control or in the event a director ceases to serve as a member of the Board due to death or disability. Directors can elect to defer or re-defer RSU and/or deferred share unit (DSU) awards under the Company’s 2004 Non-Employee Director Compensation and Deferred Share Unit Plan, as amended. The directors received a total of approximately 105,000 RSUs in June 2023. Prior to 2023, non-employee directors were granted DSUs with similar vesting to the RSUs. Pursuant to the Compensation Policy for Non-Employee Directors, as amended, non-employee directors also receive stock option awards upon initial election to the Board of Directors and annually thereafter. The directors received a total of approximately 157,000 and 322,000 options in 2023 and 2022, respectively. Compensation expense related to stock options and RSUs for the three and nine months ended September 30, 2023 and 2022 is included in the amounts discussed in the “Stock-Based Compensation” section of Note B above. In addition, pursuant to the Compensation Policy for Non-Employee Directors, as amended, the Company may issue the Company’s common stock in lieu of cash to pay fees earned by the Company’s directors at each director’s election. The directors received a total of 14,112 shares of the Company’s common stock in lieu of cash in 2023. Prior to 2023, directors could not elect to receive the Company’s common stock in lieu of cash. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Leases | J. Leases The Company currently has one There have been no material changes in lease obligations from those disclosed in Note K, “Leases,” to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | K. Commitments and Contingencies Manufacturing Commitments As of September 30, 2023, the Company had noncancelable obligations under several agreements related to in-process and future manufacturing of antibody, drug substance, linker, and cytotoxic agents required for supply of the Company’s product candidates totaling $45.3 million. Additionally, pursuant to commercial agreements for future production of antibody, the Company’s noncancelable commitments total $47.3 million at September 30, 2023. Litigation The Company is not a party to any material litigation. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions | |
Related Party Transactions | L. Related Party Transactions entered into an exchange agreement with RA Capital pursuant to which RA Capital agreed to exchange 21,853,000 shares of the Company’s common stock for 21,853 shares of newly designated Series A Convertible Preferred Stock. No cash was exchanged related to the transaction. Further details of the agreement can be found in Note I, “Capital Stock.” Stuart A. Arbuckle serves as the chief operating officer at Vertex and has served as a member of the Company’s board of directors since 2018. In February 2023, the Company entered into a multi-target license and option agreement with Vertex, pursuant to which the Company granted Vertex rights to the Company’s ADC technology to research and evaluate ADCs to specified targets, further details of which can be found in Note C, “Collaboration and License Agreements.” The Company’s chief executive officer has served as a director on the board of directors of Ergomed PLC since June 2021. In 2022, the Company executed agreements with Ergomed Clinical Research, Inc. and PrimeVigilance USA, Inc., subsidiaries of Ergomed PLC, for clinical trial and pharmacovigilance-related services. Ergomed Clinical Research, Inc. and PrimeVigilance USA, Inc. are each considered related parties pursuant to ASC 850, Related Party Disclosures |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events | |
Subsequent Events | M. Subsequent Events The Company has evaluated all events or transactions that occurred after September 30, 2023, up through the date the Company issued these financial statements. The Company did not have any material subsequent events. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended | 9 Months Ended |
Jun. 30, 2023 | Sep. 30, 2023 | |
Summary of Significant Accounting Policies | ||
Basis of Presentation | Basis of Presentation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated. The consolidated financial statements include all of the adjustments, consisting only of normal recurring adjustments, which management considers necessary for a fair presentation of the Company’s financial position in accordance with accounting principles generally accepted in the U.S. for interim financial information. The December 31, 2022 consolidated balance sheet presented for comparative purposes was derived from the Company’s audited financial statements, and certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. The preparation of interim financial statements requires the use of management’s estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements and the reported amounts of revenues and expenditures during the reported periods. The results of the interim periods are not necessarily indicative of the results for the entire year. Accordingly, the interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023. | |
Significant Accounting Policies | Significant Accounting Policies There were no changes to significant accounting policies used in preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2023, from those discussed in Note B to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. | |
Revenue Recognition | Revenue Recognition Transaction Price Allocated to Future Performance Obligations Deferred revenue under Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC), Revenue from Contracts with Customers 13 61 ® Contract Balances from Contracts with Customers The following tables present changes in the Company’s contract assets and contract liabilities during the nine months ended September 30, 2023 and 2022 (in thousands): Balance at Balance at December 31, 2022 Additions Deductions Impact of Netting September 30, 2023 Contract liabilities (deferred revenue) $ 50,211 $ 23,227 $ (9,534) $ — $ 63,904 Balance at Balance at December 31, 2021 Additions Deductions Impact of Netting September 30, 2022 Contract asset $ 3,000 $ — $ (3,000) $ — $ — Contract liabilities (deferred revenue) $ 92,068 $ 5,704 $ (43,961) $ — $ 53,811 The Company recognized the following revenues as a result of changes in contract asset and contract liability balances in the respective periods (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Revenue recognized in the period from: Amounts included in contract liabilities at the beginning of the period $ 3,929 $ 7,337 $ 9,534 $ 43,961 The timing of revenue recognition, billings, and cash collections results in billed receivables, unbilled receivables, contract assets, and contract liabilities on the consolidated balance sheets. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded (under the caption deferred revenue). Contract liabilities are recognized as revenue after control of the products or services is transferred to the customer and all revenue recognition criteria have been met. During the nine months ended September 30, 2023, a $23.2 million upfront payment received pursuant to a collaboration and license agreement with Takeda Pharmaceutical Company Limited (Takeda) was recorded as deferred revenue and none of this amount was recognized as revenue during the nine months ended September 30, 2023. Additionally, the Company received an upfront payment of $15.0 million pursuant to a multi-target license and option agreement executed with Vertex Pharmaceuticals Incorporated (Vertex) which was recorded as license and milestone fee revenue in the nine months ended September 30, 2023. Further details of these agreements can be found in Note C, “Collaboration and License Agreements.” During the nine months ended September 30, 2023, the Company also recognized $9.4 million of previously deferred non-cash royalty revenue related to the sale of rights to KADCYLA During the nine months ended September 30, 2022, pursuant to the Company’s license agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Huadong), upon delivery of clinical materials in the nine months ended September 30, 2022, the Company recognized as license and milestone fee revenue the remaining $28.5 million of the deferred revenue balance as of December 31, 2021, related to the $45.0 million of upfront and development milestone payments previously received. Additionally, pursuant to a license agreement executed with Eli Lilly and Company (Lilly), during the nine months ended September 30, 2022, the Company received upfront payments of $19.5 million, of which $13.8 million was recognized as license and milestone fee revenue and the remainder deferred. The Company also recognized $12.5 million of previously deferred non-cash royalty revenue related to the sale of rights to KADCYLA $2.9 million of license and milestone fee revenue related to numerous collaborators’ rights to technological improvements that had been previously deferred, which includes $2.8 million related to Novartis Institutes for BioMedical Research, Inc.’s (Novartis) termination of certain of the license agreements between the Company and Novartis in August 2022. | |
Financial Instruments and Concentration of Credit Risk | Financial Instruments and Concentration of Credit Risk Cash and cash equivalents are primarily maintained with three financial institutions in the U.S. Deposits with banks may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, the Company does not believe it is exposed to significant risk. The Company’s cash equivalents consist of money market funds with underlying investments primarily being U.S. Government-issued securities and high quality, short-term commercial paper. Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, and marketable securities. The Company held no marketable securities as of September 30, 2023 and December 31, 2022. The Company’s investment policy, approved by the Board of Directors, limits the amount it may invest in any one type of investment, thereby reducing credit risk concentrations. | |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid financial instruments with maturities of three months or less when purchased to be cash equivalents. As of September 30, 2023 and December 31, 2022, the Company held $605.5 million and $275.1 million, respectively, in cash and money market funds, which were classified as cash and cash equivalents. | |
Non-cash Investing and Financing Activities | Non-cash Investing and Financing Activities The Company had $0.3 million of accrued capital expenditures as of December 31, 2022, which has been treated as a non-cash investing activity and, accordingly, is not reflected in the consolidated statement of cash flows. There were no accrued capital expenditures as of September 30, 2023. | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined under ASC 820, Fair Value Measurements and Disclosures ● Level 1 - Quoted prices in active markets for identical assets or liabilities. ● Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. As of September 30, 2023 and December 31, 2022, the Company held certain assets that are required to be measured at fair value on a recurring basis. The fair value of the Company’s cash equivalents is based on quoted prices from active markets (Level 1 inputs). The carrying amounts reflected in the consolidated balance sheets for accounts receivable, unbilled receivables, non-cash royalty receivable, prepaid and other current assets, accounts payable, accrued compensation, and other accrued liabilities approximate fair value due to their short-term nature. As of September 30, 2023, the estimated fair value and gross carrying amount of the term loan was $79.7 million and $75.0 million, respectively. The Company’s disclosed fair value of the term loan falls into the Level 2 category within the fair value level hierarchy and the fair value was determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability (other than quoted prices), such as interest rates that are observable at commonly quoted intervals. | |
Accounts Receivable | Accounts Receivable Accounts receivable arise from product sales and amounts due from the Company’s collaboration partners. The amount from product sales represents amounts due from specialty distributors and specialty pharmacy providers in the U.S. The Company monitors economic conditions and the financial performance and credit worthiness of its counterparties to identify facts or circumstances that may indicate that its receivables are at risk of collection. The Company provides reserves against accounts receivable for estimated losses that may result from a customer’s inability to pay based on the composition of its accounts receivable, considering past events, current economic conditions, and reasonable and supportable forecasts about the future economic conditions. The contractual life of accounts receivable is generally short-term. Amounts determined to be uncollectible are charged or written off against the reserve. For the three and nine months ended September 30, 2023 and 2022, the Company did not record any expected credit losses related to outstanding accounts receivable. | |
Inventory | Inventory Inventories are stated at the lower of cost or estimated net realizable value with cost based on the first-in first-out method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials. The Company classifies its inventory costs as long-term when it expects to utilize the inventory beyond its normal operating cycle based on forecasted levels of sales. Prior to the regulatory approval of its drug candidates, the Company incurs expenses for the manufacture of drug product to support clinical development that could potentially be available to support the commercial launch of those drugs. Until the date at which regulatory approval has been received or is otherwise considered probable, the Company records all such costs as research and development expenses. The Company performs an assessment of the recoverability of capitalized inventories during each reporting period and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded as a component of cost of sales in the consolidated statements of operations and comprehensive loss. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. There were no expenses recorded for excess inventory or other impairments during the three and nine months ended September 30, 2023. There was no inventory held by the Company during the three and nine months ended September 30, 2022. | |
Debt issuance costs and debt discount | Debt issuance costs and debt discount Debt issuance costs and debt discounts are presented on the accompanying consolidated balance sheets as a direct reduction from the carrying value of the debt and are amortized to interest expense over the term of the related debt using the effective interest method. See Note G, “Senior Secured Term Loan” for further discussion related to long-term debt. | |
Computation of Net Loss per Common Share | Computation of Net Loss per Common Share Basic and diluted net loss per share is calculated based upon the weighted average number of shares of common stock outstanding during the period. Shares of the Company’s common stock, par value $.01 per share, underlying pre-funded warrants are included in the calculation of basic and diluted earnings per share. Shares of the Company’s Series A Convertible Preferred Stock participate in any dividends that may be declared by the Company and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of income, participating securities are allocated a proportional share of income determined by dividing total weighted-average participating securities by the sum of the total weighted average common shares and participating securities (the two-class method). During periods of loss, no loss is allocated to participating securities since they have no contractual obligation to share in the losses of the Company. Diluted loss per share is computed after giving consideration to the dilutive effect of stock options and restricted stock units that are outstanding during the period, except where such non-participating securities would be antidilutive. The dilutive effect of participating securities is calculated using the more dilutive of either (i) the treasury stock method (for stock options and restricted stock units) and “if-converted” method (for Series A Convertible Preferred Stock) or (ii) the two-class method assuming the Series A Convertible Preferred Stock is not converted and applying the treasury stock method (for stock options and restricted stock units). The following table sets forth the computation of basic and diluted earnings per share for the three months ended September 30, 2023. There was a net loss in all other periods presented, and as such, no loss was allocated to participating securities pursuant to the two class method for those periods. Three Months Ended September 30, 2023 Numerator: Net income $ 30,748 Allocation of earnings to participating securities (2,276) Numerator for basic EPS — income available to common stockholders (A) $ 28,472 Effect of dilutive securities: Add back allocation of earnings to participating securities $ 2,276 Reallocation of earnings to participating securities considering potentially dilutive securities (2,171) Numerator for diluted EPS — income available to common stockholders (C) $ 28,577 Denominator: Denominator for basic EPS — weighted average shares (B) 273,341 Effect of dilutive securities: Common stock equivalents 14,249 Denominator for diluted EPS — adjusted weighted average shares (D) 287,590 Basic EPS (A / B) $ 0.10 Diluted EPS (C / D) $ 0.10 The Company’s common stock equivalents, as calculated in accordance with the treasury-stock method for options and unvested restricted stock units and the if-converted method for the Series A Convertible Preferred Stock, are shown in the following table (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Options outstanding to purchase common stock, shares issuable under the employee stock purchase plan, and unvested restricted stock units at end of period 29,927 31,479 29,927 31,479 Common stock equivalents under treasury stock method for options, shares issuable under the employee stock purchase plan, and unvested restricted stock units 14,249 2,246 10,671 1,437 Common stock equivalents under if-converted method for Series A Convertible Preferred Stock 21,853 — 21,853 — | |
Stock-Based Compensation | Stock-Based Compensation As of September 30, 2023, the Company was authorized to grant future awards under three employee share-based compensation plans, which are the ImmunoGen, Inc. Amended and Restated 2018 Employee, Director and Consultant Equity Incentive Plan (the 2018 Plan), the Employee Stock Purchase Plan (the ESPP), and the ImmunoGen Inducement Equity Incentive Plan (the Inducement Plan). At the annual meeting of shareholders on June 15, 2022, the 2018 Plan was amended to provide for the issuance of stock grants, the grant of options, and the grant of stock-based awards for up to an additional 13,000,000 shares of the Company’s common stock, as well as up to 28,742,013 shares of common stock, which represent the number of shares of common stock remaining under the 2018 Plan as of April 1, 2022, and awards previously granted under the 2018 Plan and the Company’s former stock-based plans, including the ImmunoGen, Inc. 2016 and 2006 Employee, Director and Consultant Equity Incentive Plans, that forfeit, expire, or cancel without delivery of shares of common stock or which resulted in the forfeiture of shares of common stock back to the Company subsequent to April 1, 2022. The Inducement Plan was approved by the Board of Directors in December 2019, and pursuant to subsequent amendments, provides for the issuance of non-qualified option grants for up to 13,500,000 shares of the Company’s common stock. Options awarded under the two plans are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Options vest at various periods of up to four years and may be exercised within ten years of the date of grant under each of these plans. The stock-based awards are accounted for under ASC 718, Compensation—Stock Compensation Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Dividend None None None None Volatility 88.4% 83.3% 83.4% 83.2% Risk-free interest rate 4.52% 3.44% 3.78% 2.48% Expected life (years) 5.6 5.6 5.7 5.9 Using the Black-Scholes option-pricing model, the weighted-average grant date fair values of options granted during the three months ended September 30, 2023 and 2022 were $11.52 and $3.62 per share, respectively, and $4.85 and $3.58 for options granted during the nine months ended September 30, 2023 and 2022, respectively. A summary of option activity under the Company’s equity plans for the nine months ended September 30, 2023 is presented below (in thousands, except weighted-average data): Weighted- Number Average of Stock Exercise Options Price Outstanding at December 31, 2022 33,126 $ 5.76 Granted 6,316 6.71 Exercised (9,121) 5.05 Forfeited/Canceled (2,653) 6.30 Outstanding at September 30, 2023 27,668 $ 6.15 In 2020, the Company issued 2.6 million performance-based stock options to certain employees with vesting conditioned upon the achievement of specified performance goals. In 2022, 75% of the 2.6 million performance-based stock options vested upon achievement of specified performance goals and 12.5% were forfeited. There was no stock-based compensation recorded during the three or nine months ended September 30, 2023 related to these stock options. The fair value of the remaining unvested performance-based stock options that could be expensed in future periods is $1.3 million. A summary of restricted stock unit activity under the Company’s equity plans for the nine months ended September 30, 2023 is presented below (in thousands, except weighted-average data): Number of Weighted- Restricted Average Grant Stock Shares Date Fair Value Unvested at December 31, 2022 138 $ 5.45 Granted 2,380 6.32 Forfeited (259) 4.66 Unvested at September 30, 2023 2,259 $ 7.11 In June 2018, the Company's Board of Directors, with shareholder approval, adopted the Employee Stock Purchase Plan (ESPP). Following the automatic share increase on January 1, 2021, pursuant to the ESPP’s “evergreen” provision, an aggregate of 2,000,000 shares of common stock have been reserved for issuance under the ESPP. ESPP purchase periods are six months and begin on January 1 and July 1 of each year, with purchase dates occurring on the final business day of the given purchase period. The fair value of each ESPP award is estimated on the first day of the offering period using the Black-Scholes option-pricing model. The Company recognizes share-based compensation expense equal to the fair value of the ESPP awards on a straight-line basis over the offering period. Stock compensation expense related to stock options and restricted stock unit awards granted under the stock plans and the ESPP was $7.8 million and $22.0 million during the three and nine months ended September 30, 2023, respectively, compared to $5.3 million and $14.3 million for the three and nine months ended September 30, 2022, respectively. The increase in stock compensation expense is primarily due to significant growth in personnel in the second half of 2022. As of September 30, 2023, the estimated fair value of unvested employee awards was $72.0 million. The weighted-average remaining vesting period for these awards is approximately three years. | |
Segment Information | During all periods presented, the Company continued to operate in one reportable business segment under the management approach of ASC 280, Segment Reporting During the three months ended September 30, 2023, 93% of revenues were generated from net U.S. sales of ELAHERE to four specialty distributors and specialty pharmacy providers, and 7% of revenues were generated from an agreement with Roche, compared to 52%, 30% and 18% of revenues from Roche, Lilly and Novartis, respectively, during the three months ended September 30, 2022. During the nine months ended September 30, 2023, 86% of revenues were generated from net U.S. sales of ELAHERE to four specialty distributors and specialty pharmacy providers, and 7% and 6% of revenues were generated from agreements with Roche and Vertex, respectively, compared to 43%, 32% and 20% from agreements with Huadong, Roche, and Lilly, respectively, during the nine months ended September 30, 2022. There were no other customers of the Company that generated significant revenues in the three and nine months ended September 30, 2023 and 2022. | |
Pending Accounting Pronouncements | Recently Adopted Accounting Pronouncements There were no recently issued or effective FASB Accounting Standards Updates (ASUs) that had, or are expected to have, a material effect on the Company's results of operations, financial condition, or liquidity. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Contract assets and contract liabilities | The following tables present changes in the Company’s contract assets and contract liabilities during the nine months ended September 30, 2023 and 2022 (in thousands): Balance at Balance at December 31, 2022 Additions Deductions Impact of Netting September 30, 2023 Contract liabilities (deferred revenue) $ 50,211 $ 23,227 $ (9,534) $ — $ 63,904 Balance at Balance at December 31, 2021 Additions Deductions Impact of Netting September 30, 2022 Contract asset $ 3,000 $ — $ (3,000) $ — $ — Contract liabilities (deferred revenue) $ 92,068 $ 5,704 $ (43,961) $ — $ 53,811 The Company recognized the following revenues as a result of changes in contract asset and contract liability balances in the respective periods (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Revenue recognized in the period from: Amounts included in contract liabilities at the beginning of the period $ 3,929 $ 7,337 $ 9,534 $ 43,961 |
Schedule of common stock equivalents, as calculated in accordance with the treasury-stock method | The following table sets forth the computation of basic and diluted earnings per share for the three months ended September 30, 2023. There was a net loss in all other periods presented, and as such, no loss was allocated to participating securities pursuant to the two class method for those periods. Three Months Ended September 30, 2023 Numerator: Net income $ 30,748 Allocation of earnings to participating securities (2,276) Numerator for basic EPS — income available to common stockholders (A) $ 28,472 Effect of dilutive securities: Add back allocation of earnings to participating securities $ 2,276 Reallocation of earnings to participating securities considering potentially dilutive securities (2,171) Numerator for diluted EPS — income available to common stockholders (C) $ 28,577 Denominator: Denominator for basic EPS — weighted average shares (B) 273,341 Effect of dilutive securities: Common stock equivalents 14,249 Denominator for diluted EPS — adjusted weighted average shares (D) 287,590 Basic EPS (A / B) $ 0.10 Diluted EPS (C / D) $ 0.10 The Company’s common stock equivalents, as calculated in accordance with the treasury-stock method for options and unvested restricted stock units and the if-converted method for the Series A Convertible Preferred Stock, are shown in the following table (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Options outstanding to purchase common stock, shares issuable under the employee stock purchase plan, and unvested restricted stock units at end of period 29,927 31,479 29,927 31,479 Common stock equivalents under treasury stock method for options, shares issuable under the employee stock purchase plan, and unvested restricted stock units 14,249 2,246 10,671 1,437 Common stock equivalents under if-converted method for Series A Convertible Preferred Stock 21,853 — 21,853 — |
Schedule of risk-free rate of the stock options based on US Treasury rate | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Dividend None None None None Volatility 88.4% 83.3% 83.4% 83.2% Risk-free interest rate 4.52% 3.44% 3.78% 2.48% Expected life (years) 5.6 5.6 5.7 5.9 |
Summary of stock option activity | A summary of option activity under the Company’s equity plans for the nine months ended September 30, 2023 is presented below (in thousands, except weighted-average data): Weighted- Number Average of Stock Exercise Options Price Outstanding at December 31, 2022 33,126 $ 5.76 Granted 6,316 6.71 Exercised (9,121) 5.05 Forfeited/Canceled (2,653) 6.30 Outstanding at September 30, 2023 27,668 $ 6.15 |
Summary of restricted stock activity | A summary of restricted stock unit activity under the Company’s equity plans for the nine months ended September 30, 2023 is presented below (in thousands, except weighted-average data): Number of Weighted- Restricted Average Grant Stock Shares Date Fair Value Unvested at December 31, 2022 138 $ 5.45 Granted 2,380 6.32 Forfeited (259) 4.66 Unvested at September 30, 2023 2,259 $ 7.11 |
Product Revenue Reserves and _2
Product Revenue Reserves and Allowances (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Product Revenue Reserves and Allowances | |
Schedule of product revenue allowance and reserve categories | The following table summarizes activity in each of the product revenue reserve and allowance categories as of September 30, 2023 and 2022, respectively. (in thousands): September 30, September 30, 2023 2022 Beginning balance at January 1 $ 313 $ — Provision related to sales in the current period 36,012 — Credits and payments made (28,223) — Ending balance at September 30 $ 8,102 $ — |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory | |
Schedule of capitalized inventory | Capitalized inventory consists of the following at September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, 2023 2022 Raw materials $ 28,555 $ 15,952 Work in process 2,839 — Finished goods 2,374 244 Total inventory $ 33,768 $ 16,196 |
Liability Related to Sale of _2
Liability Related to Sale of Future Royalties (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Liability Related to Sale of Future Royalties | |
Schedule of Liability account during the period from the inception of the royalty transaction | The following table shows the activity within the liability account during the nine-month period ended September 30, 2023 (in thousands): Nine Months Ended September 30, 2023 Liability related to sale of future royalties, net — beginning balance $ 32,108 Proceeds from sale of future royalties, net — KADCYLA royalty payments received and paid (8,907) Non-cash interest expense recognized 2,691 Liability related to sale of future royalties, net — ending balance $ 25,892 |
Nature of Business and Plan o_2
Nature of Business and Plan of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Apr. 06, 2023 | Dec. 31, 2022 | |
Net loss | $ (14,514) | $ (163,921) | ||||
Accumulated deficit | $ (1,708,586) | (1,708,586) | $ (1,694,072) | |||
Total revenues | 113,425 | $ 15,375 | 246,447 | $ 67,615 | ||
Cash and cash equivalents | 605,535 | 605,535 | $ 275,138 | |||
Senior Secured Term Loan, Tranche One [Member] | ||||||
Senior secured term loan | $ 75,000 | |||||
Secured Debt [Member] | ||||||
Senior secured term loan | 175,000 | |||||
Secured Debt [Member] | Senior Secured Term Loan, Tranche One [Member] | ||||||
Senior secured term loan | 75,000 | 75,000 | ||||
Secured Debt [Member] | Senior Secured Term Loan, Tranche Two [Member] | Minimum | ||||||
Senior secured term loan | $ 50,000 | $ 50,000 | 50,000 | |||
Secured Debt [Member] | Senior Secured Term Loan, Tranche Two [Member] | Maximum | ||||||
Senior secured term loan | $ 100,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Significant Account Policies (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Apr. 06, 2023 |
Senior Secured Term Loan, Tranche One [Member] | ||
Debt Instrument [Line Items] | ||
Senior secured term loan | $ 75,000 | |
Secured Debt [Member] | ||
Debt Instrument [Line Items] | ||
Senior secured term loan | 175,000 | |
Secured Debt [Member] | Senior Secured Term Loan, Tranche One [Member] | ||
Debt Instrument [Line Items] | ||
Senior secured term loan | $ 75,000 | |
Secured Debt [Member] | Senior Secured Term Loan, Tranche Two [Member] | Minimum | ||
Debt Instrument [Line Items] | ||
Senior secured term loan | $ 50,000 | 50,000 |
Secured Debt [Member] | Senior Secured Term Loan, Tranche Two [Member] | Maximum | ||
Debt Instrument [Line Items] | ||
Senior secured term loan | $ 100,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Revenue Recognition (Details) | 1 Months Ended |
Aug. 31, 2023 | |
Takeda | |
Summary of Significant Accounting Policies | |
Term of agreement | 1 year 6 months |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Performance Obligations (Details) $ in Millions | Sep. 30, 2023 USD ($) |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Revenue, Remaining Performance Obligation | $ 63.9 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-07-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Remaining performance obligations, percent | 0.58% |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-07-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Remaining performance obligations, percent | 0.41% |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2032-07-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Remaining performance obligations, percent | 0.01% |
Minimum | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-07-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Remaining performance obligation, expected timing of satisfaction | 12 months |
Minimum | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-07-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Remaining performance obligation, expected timing of satisfaction | 13 months |
Minimum | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2032-07-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Remaining performance obligation, expected timing of satisfaction | 61 months |
Maximum | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-07-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Remaining performance obligation, expected timing of satisfaction | 60 months |
Maximum | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2032-07-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Remaining performance obligation, expected timing of satisfaction | 120 months |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Contract Balances (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Changes in the Company's contract assets and contract liabilities | ||
Contract asset, Beginning balance | $ 3,000 | |
Contract asset, Additions | 0 | |
Contract asset, Deductions | 3,000 | |
Contract liabilities: | ||
Contract liabilities (deferred revenue), Beginning balance | $ 50,211 | 92,068 |
Contract liabilities (deferred revenue), Additions | 23,227 | 5,704 |
Contract liabilities (deferred revenue), Deductions | (9,534) | (43,961) |
Contract liabilities (deferred revenue), Ending balance | $ 63,904 | $ 53,811 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Revenues Recognized as a Result of Changes in Contract Asset and Liability Balances (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue recognized in the period from: | ||||
Amounts included in contract liabilities at the beginning of the period | $ 3,929 | $ 7,337 | $ 9,534 | $ 43,961 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Contract Balances from Contracts with Customers - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Aug. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Feb. 28, 2023 | Dec. 31, 2022 | Feb. 28, 2022 | Dec. 31, 2021 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Contract with customer liability | $ 63,904 | $ 53,811 | $ 63,904 | $ 53,811 | $ 50,211 | $ 92,068 | |||
Revenue from contract with customer | 113,425 | 15,375 | 246,447 | 67,615 | |||||
Revenue recognized, previously deferred | 3,929 | 7,337 | 9,534 | 43,961 | |||||
Current portion of deferred revenue | 37,186 | 37,186 | 13,856 | ||||||
Deferred revenue, net of current portion | 26,718 | 26,718 | $ 36,355 | ||||||
License and milestone fees | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Revenue from contract with customer | 51 | 7,382 | 15,122 | 45,247 | |||||
Future Technological Improvements | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Revenue from contract with customer | 100 | ||||||||
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd | License and milestone fees | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Revenue recognized, previously deferred | 28,500 | ||||||||
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd | Upfront payment | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
License agreement upfront payment receivable | 45,000 | 45,000 | |||||||
Lilly | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
License agreement upfront payment receivable | $ 13,000 | ||||||||
Lilly | License and milestone fees | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Revenue from contract with customer | 13,800 | ||||||||
Lilly | Upfront payment | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
License agreement upfront payment receivable | $ 19,500 | 19,500 | |||||||
KADCYLA | License and milestone fees | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Revenue recognized, previously deferred | 2,900 | ||||||||
KADCYLA | Royalty revenue | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Net proceeds from sale of residual rights to receive royalty payments | 9,400 | ||||||||
Revenue recognized, previously deferred | 12,500 | ||||||||
Novartis | License and milestone fees | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Revenue recognized, previously deferred | $ 2,800 | ||||||||
Vertex | License and milestone fees | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Revenue from contract with customer | 15,000 | ||||||||
Vertex | Upfront payment | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
License agreement upfront payment receivable | $ 15,000 | ||||||||
Revenue from contract with customer | 15,000 | ||||||||
Takeda | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Revenue from contract with customer | 0 | ||||||||
Takeda | Upfront payment | |||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||
Revenue from contract with customer | $ 23,200 | ||||||||
Deferred revenue, net of current portion | $ 23,200 | $ 23,200 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Financial Instruments and Concentration of Credit Risk (Details) | 9 Months Ended | |
Sep. 30, 2023 USD ($) item | Dec. 31, 2022 USD ($) | |
Financial Instruments and Concentration of Credit Risk | ||
Number of financial institutions in the U.S. in which cash and cash equivalents are primarily maintained | item | 3 | |
Marketable securities held by entity | $ | $ 0 | $ 0 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Summary of Significant Accounting Policies | ||
Cash and cash equivalents | $ 605,535 | $ 275,138 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Non-cash Investing and Financing Activities (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Sep. 30, 2023 | |
Summary of Significant Accounting Policies | ||
Accrued capital expenditures | $ 0.3 | |
Gross carrying amount | $ 75 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies - Fair Value of Financial Instruments (Details) $ / shares in Units, $ in Millions | Sep. 30, 2023 USD ($) $ / shares |
Summary of Significant Accounting Policies | |
Estimated fair value | $ 79.7 |
Gross carrying amount | $ 75 |
Common stock, par value (in dollars per share) | $ / shares | $ 0.01 |
Summary of Significant Accou_14
Summary of Significant Accounting Policies - Accounts Receivable (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Summary of Significant Accounting Policies | ||
Expected credit losses | $ 8,102 | $ 313 |
Summary of Significant Accou_15
Summary of Significant Accounting Policies - Inventory (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Summary of Significant Accounting Policies | ||
Inventory | $ 5,495,000 | $ 0 |
Inventory impairment | $ 0 |
Summary of Significant Accou_16
Summary of Significant Accounting Policies - Computation of Net Loss per Common Share (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Computation of Net Loss per Common Share | ||||
Options outstanding to purchase common stock, shares issuable under the employee stock purchase plan, and unvested restricted stock/units at end of period | 29,927 | 31,479 | 29,927 | 31,479 |
Common stock equivalents under treasury stock method for options, shares issuable under the employee stock purchase plan, and unvested restricted stock/units | 14,249 | 2,246 | 10,671 | 1,437 |
Common stock equivalents under if-converted method for Series A Convertible Preferred Stock | 21,853 | 21,853 |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies - Schedule of two class method (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |||||||||
Net loss | $ 30,748 | $ (4,248) | $ (41,014) | $ (59,008) | $ (77,755) | $ (62,021) | $ (24,145) | $ (14,514) | $ (163,921) |
Allocation of earnings to participating securities | (2,276) | ||||||||
Numerator for basic EPS - income available to common stockholders (A) | 28,472 | ||||||||
Add back allocation of earnings to participating securities | 2,276 | ||||||||
Reallocation of earnings to participating securities considering potentially dilutive securities | (2,171) | ||||||||
Numerator for diluted EPS - income available to common stockholders (C) | $ 28,577 | ||||||||
Denominator for basic EPS - weighted average shares (B) | 273,341 | 253,511 | 265,265 | 253,371 | |||||
Common stock equivalents | 14,249 | 2,246 | 10,671 | 1,437 | |||||
Denominator for diluted EPS - adjusted weighted average shares (D) | 287,590 | 253,511 | 265,265 | 253,371 | |||||
Basic EPS (A/B) | $ 0.10 | $ (0.31) | $ (0.05) | $ (0.65) | |||||
Diluted EPS (C/D) | $ 0.10 | $ (0.31) | $ (0.05) | $ (0.65) |
Summary of Significant Accou_17
Summary of Significant Accounting Policies - Segment Information (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 item | Sep. 30, 2022 | Sep. 30, 2023 item segment | Sep. 30, 2022 | Dec. 31, 2022 segment | |
Segment Information | |||||
Number of operating segments | segment | 1 | 1 | |||
Other customers | Revenue | Customer concentration | |||||
Segment Information | |||||
Percentages of revenue recognized | 0% | 0% | 0% | 0% | |
Specialty distributors and pharmacy providers | Revenue | Customer concentration | |||||
Segment Information | |||||
Number of operating segments | item | 4 | 4 | |||
Percentages of revenue recognized | 93% | 86% | |||
Roche | Revenue | Customer concentration | |||||
Segment Information | |||||
Percentages of revenue recognized | 7% | 52% | 7% | 32% | |
Huadong | Revenue | Customer concentration | |||||
Segment Information | |||||
Percentages of revenue recognized | 43% | ||||
Lilly | Revenue | Customer concentration | |||||
Segment Information | |||||
Percentages of revenue recognized | 30% | 20% | |||
Novartis | Revenue | Customer concentration | |||||
Segment Information | |||||
Percentages of revenue recognized | 18% | ||||
Vertex Pharmaceuticals Incorporated [Member] | Revenue | Customer concentration | |||||
Segment Information | |||||
Percentages of revenue recognized | 6% |
Summary of Significant Accou_18
Summary of Significant Accounting Policies - Stock-Based Compensation (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Sep. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) shares | Mar. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) plan $ / shares shares | Sep. 30, 2022 USD ($) $ / shares | Dec. 31, 2022 $ / shares shares | Dec. 31, 2020 shares | Jun. 30, 2018 shares | |
Stock-Based Compensation | ||||||||||||
Number of employee share-based compensation plans | plan | 3 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | 0 | |||||||||||
Weighted-average assumptions used to estimate the fair value of each stock option | ||||||||||||
Dividend (as a percent) | 0% | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||||||||||||
Directors' deferred share unit compensation | $ | $ 67 | $ 152 | $ 151 | $ 146 | $ 146 | $ 213 | $ 211 | |||||
ESPP | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||||||||||||
Aggregate number of common shares reserved for future issuance | 2,000,000 | |||||||||||
Stock options and restricted stock awards | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||||||||||||
Stock compensation expense | $ | 7,800 | $ 5,300 | $ 22,000 | $ 14,300 | ||||||||
Estimated fair value that could be expensed | $ | $ 72,000 | $ 72,000 | ||||||||||
Stock options | ||||||||||||
Weighted-average assumptions used to estimate the fair value of each stock option | ||||||||||||
Dividend (as a percent) | 0% | 0% | 0% | 0% | ||||||||
Volatility (as a percent) | 88.40% | 83.30% | 83.40% | 83.20% | ||||||||
Risk-free interest rate (as a percent) | 4.52% | 3.44% | 3.78% | 2.48% | ||||||||
Expected life | 5 years 7 months 6 days | 5 years 7 months 6 days | 5 years 8 months 12 days | 5 years 10 months 24 days | ||||||||
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 11.52 | $ 3.62 | $ 4.85 | $ 3.58 | ||||||||
Number of Stock Options | ||||||||||||
Outstanding at the beginning of the period (in shares) | 33,126,000 | 33,126,000 | ||||||||||
Granted (in shares) | 6,316,000 | |||||||||||
Exercised (in shares) | (9,121,000) | |||||||||||
Forfeited/Canceled (in shares) | (2,653,000) | |||||||||||
Outstanding at the end of the period (in shares) | 27,668,000 | 33,126,000 | 27,668,000 | 33,126,000 | ||||||||
Weighted-Average Exercise Price | ||||||||||||
Outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 5.76 | $ 5.76 | ||||||||||
Granted (in dollars per share) | $ / shares | 6.71 | |||||||||||
Exercised (in dollars per share) | $ / shares | 5.05 | |||||||||||
Forfeited/Canceled (in dollars per share) | $ / shares | 6.30 | |||||||||||
Outstanding at the end of the period (in dollars per share) | $ / shares | $ 6.15 | $ 5.76 | $ 6.15 | $ 5.76 | ||||||||
Performance shares | ||||||||||||
Stock-Based Compensation | ||||||||||||
Vesting percentage | 75% | |||||||||||
Forfeited percentage | 12.50% | |||||||||||
Number of Stock Options | ||||||||||||
Granted (in shares) | 2,600,000 | 2,600,000 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||||||||||||
Estimated fair value that could be expensed | $ | $ 1,300 | $ 1,300 | ||||||||||
Restricted stock | ||||||||||||
Number of Restricted Stock Shares | ||||||||||||
Unvested at the beginning of the period (in shares) | 138,000 | 138,000 | ||||||||||
Granted (in shares) | 2,380,000 | |||||||||||
Forfeited (in shares) | (259,000) | |||||||||||
Unvested at the end of the period (in shares) | 2,259,000 | 138,000 | 2,259,000 | 138,000 | ||||||||
Weighted-Average Grant Date Fair Value | ||||||||||||
Unvested at the beginning of the period (in dollars per share) | $ / shares | $ 5.45 | $ 5.45 | ||||||||||
Granted (in dollars per share) | $ / shares | 6.32 | |||||||||||
Forfeited (in dollars per share) | $ / shares | 4.66 | |||||||||||
Unvested at the end of the period (in dollars per share) | $ / shares | $ 7.11 | $ 5.45 | $ 7.11 | $ 5.45 | ||||||||
Immunogen Inc Restated Stock Option Plan | ||||||||||||
Stock-Based Compensation | ||||||||||||
Common stock authorized for issuance (in shares) | 28,742,013 | 28,742,013 | ||||||||||
2018 Plan | ||||||||||||
Stock-Based Compensation | ||||||||||||
Common stock authorized for issuance (in shares) | 13,000,000 | 13,000,000 | ||||||||||
Inducement Plan | ||||||||||||
Stock-Based Compensation | ||||||||||||
Number of employee share-based compensation plans | plan | 2 | |||||||||||
Common stock authorized for issuance (in shares) | 13,500,000 | 13,500,000 | ||||||||||
2018 Plan and Inducement Plan | ||||||||||||
Stock-Based Compensation | ||||||||||||
Exercise period | 10 years | |||||||||||
2018 Plan and Inducement Plan | Maximum | ||||||||||||
Stock-Based Compensation | ||||||||||||
Vesting period | 4 years |
Collaboration and License Agr_2
Collaboration and License Agreements - Roche (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborative Agreements disclosures | ||||
Revenue from contract with customer | $ 113,425 | $ 15,375 | $ 246,447 | $ 67,615 |
Non-cash royalty revenue related to sale of future royalties | (8,494) | (9,027) | ||
License and milestone fees | ||||
Collaborative Agreements disclosures | ||||
Revenue from contract with customer | $ 51 | $ 7,382 | $ 15,122 | 45,247 |
Roche | ||||
Collaborative Agreements disclosures | ||||
Period in arrears to receive royalty reports and payments related to sales of kadcyla | 3 months | |||
Roche | KADCYLA | ||||
Collaborative Agreements disclosures | ||||
Non-cash royalty revenue related to sale of future royalties | $ (17,900) | $ (21,500) |
Collaboration and License Agr_3
Collaboration and License Agreements - Novartis (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Aug. 31, 2022 | Dec. 31, 2021 | |
Collaborative Agreements disclosures | |||||||
Revenue from contract with customer | $ 113,425 | $ 15,375 | $ 246,447 | $ 67,615 | |||
Contract with customer liability | 63,904 | 53,811 | 63,904 | 53,811 | $ 50,211 | $ 92,068 | |
Revenue recognized, previously deferred | 3,929 | 7,337 | 9,534 | 43,961 | |||
Milestone payments plus royalties on the commercial sales | Novartis | |||||||
Collaborative Agreements disclosures | |||||||
Potential milestone payment | 199,500 | 199,500 | |||||
Revenue recognized, previously deferred | 5,000 | ||||||
License and milestone fees | |||||||
Collaborative Agreements disclosures | |||||||
Revenue from contract with customer | 51 | $ 7,382 | 15,122 | 45,247 | |||
License and milestone fees | Novartis | |||||||
Collaborative Agreements disclosures | |||||||
Deferred revenue | 700 | 700 | |||||
Revenue recognized, previously deferred | 2,800 | ||||||
Research and development support | |||||||
Collaborative Agreements disclosures | |||||||
Revenue from contract with customer | $ 855 | $ 1,310 | 831 | ||||
Research and development support | Novartis | |||||||
Collaborative Agreements disclosures | |||||||
Revenue from contract with customer | $ 2,800 | ||||||
Deferred revenue | $ 2,800 |
Collaboration and License Agr_4
Collaboration and License Agreements - Viridian (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborative Agreements disclosures | ||||
Revenue from contract with customer | $ 113,425 | $ 15,375 | $ 246,447 | $ 67,615 |
License and milestone fees | ||||
Collaborative Agreements disclosures | ||||
Revenue from contract with customer | $ 51 | $ 7,382 | $ 15,122 | $ 45,247 |
Collaboration and License Agr_5
Collaboration and License Agreements - Huadong (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Oct. 31, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | |
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 113,425 | $ 15,375 | $ 246,447 | $ 67,615 | ||
Revenue recognized, previously deferred | 3,929 | 7,337 | 9,534 | 43,961 | ||
Upfront payment | Huadong | ||||||
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 40,000 | |||||
Upfront payment | Huadong | Development milestones | ||||||
Collaborative Agreements disclosures | ||||||
Revenue recognized, previously deferred | $ 45,000 | |||||
Deferred revenue | 28,500 | 28,500 | ||||
License and milestone fees | ||||||
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 51 | $ 7,382 | 15,122 | $ 45,247 | ||
License and milestone fees | Huadong | Development milestones | ||||||
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 15,000 | |||||
License and milestone fees | Huadong | Sales milestones | ||||||
Collaborative Agreements disclosures | ||||||
Potential milestone payment | $ 265,000 | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-07-01 | License and milestone fees | Huadong | Development milestones | ||||||
Collaborative Agreements disclosures | ||||||
Remaining performance obligation, expected timing of satisfaction | 2 years | 2 years |
Collaboration and License Agr_6
Collaboration and License Agreements - Takeda (Details) $ in Thousands, ¥ in Billions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Aug. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Aug. 25, 2023 JPY (¥) | |
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 113,425 | $ 15,375 | $ 246,447 | $ 67,615 | ||
Takeda | ||||||
Collaborative Agreements disclosures | ||||||
Term of agreement | 1 year 6 months | |||||
Revenue from contract with customer | 0 | |||||
Takeda | Sales milestones | ||||||
Collaborative Agreements disclosures | ||||||
Potential milestone payment | $ 135,000 | ¥ 19.9 | ||||
License and milestone fees | ||||||
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | 51 | $ 7,382 | 15,122 | 45,247 | ||
Upfront payment | Takeda | ||||||
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 23,200 | |||||
Research and development support | ||||||
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 855 | $ 1,310 | $ 831 |
Collaboration and License Agr_7
Collaboration and License Agreements - Magenta (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Revenue from contract with customer | $ 113,425 | $ 15,375 | $ 246,447 | $ 67,615 |
License and milestone fees | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Revenue from contract with customer | $ 51 | $ 7,382 | $ 15,122 | $ 45,247 |
Collaboration and License Agr_8
Collaboration and License Agreements - Lilly (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Feb. 28, 2022 | |
Collaborative Agreements disclosures | ||||||
Aggregate amount of transaction price allocated to remaining performance obligations | $ 63,900 | $ 63,900 | ||||
Revenue from contract with customer | 113,425 | $ 15,375 | 246,447 | $ 67,615 | ||
Amount of obligation included in long-term deferred revenue | 26,718 | 26,718 | $ 36,355 | |||
Lilly | ||||||
Collaborative Agreements disclosures | ||||||
License agreement upfront payment receivable | $ 13,000 | |||||
License agreement additional payment receivable | 19,500 | |||||
License agreement, target selection fees and development, regulatory and commercial milestone payments receivable | $ 1,700,000 | |||||
Lilly | Upfront payment | ||||||
Collaborative Agreements disclosures | ||||||
License agreement upfront payment receivable | $ 19,500 | 19,500 | ||||
Lilly | Initial targets | ||||||
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 13,800 | 18,400 | ||||
Lilly | Additional targets | ||||||
Collaborative Agreements disclosures | ||||||
License agreement additional payment receivable | $ 13,000 | |||||
Lilly | Material rights to obtain licenses to replacement targets | ||||||
Collaborative Agreements disclosures | ||||||
Amount of obligation included in long-term deferred revenue | $ 7,600 | $ 7,600 |
Collaboration and License Agr_9
Collaboration and License Agreements - Vertex (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Feb. 28, 2023 | Dec. 31, 2022 | |
Collaborative Agreements disclosures | ||||||
Aggregate amount of transaction price allocated to remaining performance obligations | $ 63,900 | $ 63,900 | ||||
Revenue from contract with customer | 113,425 | $ 15,375 | 246,447 | $ 67,615 | ||
Amount of obligation included in long-term deferred revenue | 26,718 | 26,718 | $ 36,355 | |||
License and milestone fees | ||||||
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 51 | $ 7,382 | 15,122 | $ 45,247 | ||
Vertex | Upfront payment | ||||||
Collaborative Agreements disclosures | ||||||
License agreement upfront payment receivable | $ 15,000 | |||||
License agreement, target selection fees and development, regulatory and commercial milestone payments receivable | $ 337,000 | |||||
Revenue from contract with customer | 15,000 | |||||
Vertex | License and milestone fees | ||||||
Collaborative Agreements disclosures | ||||||
Revenue from contract with customer | $ 15,000 |
Product Revenue Reserves and _3
Product Revenue Reserves and Allowances (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Product Revenue Reserves and Allowances | ||||
Beginning balance at January 1 | $ 313 | |||
Provision related to sales in the current period | 36,012 | |||
Credits and payments made | (28,223) | |||
Ending balance at December 31 | $ 8,102 | 8,102 | ||
Revenue from contract with customer | 113,425 | $ 15,375 | 246,447 | $ 67,615 |
Product revenue, net | ||||
Product Revenue Reserves and Allowances | ||||
Revenue from contract with customer | $ 105,164 | $ 212,079 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory | ||
Raw materials | $ 28,555 | $ 15,952 |
Work in process | 2,839 | |
Finished goods | 2,374 | 244 |
Total Inventory | $ 33,768 | $ 16,196 |
Liability Related to Sale of _3
Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Jan. 31, 2019 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2015 | |
Liability Related to Sale of Future Royalties | ||||
Non-cash royalty revenue related to the sale of future royalties | $ 8,494 | $ 9,027 | ||
Change in liability related to sale of future royalties | ||||
Liability related to sale of future royalties, net - beginning balance | 32,108 | |||
KADCYLA royalty payments received and paid | (8,907) | |||
Non-cash interest expense recognized | 2,691 | |||
Liability related to sale of future royalties, net - ending balance | 25,892 | |||
Kadcyla | ||||
Liability Related to Sale of Future Royalties | ||||
Percentage of royalty payments if applicable threshold is met | 85% | |||
IRH | Kadcyla | ||||
Liability Related to Sale of Future Royalties | ||||
Percentage of royalty payments | 100% | |||
Percentage of royalty payments if applicable threshold is met | 15% | |||
Transaction costs for royalty agreements | $ 5,900 | |||
Change in liability related to sale of future royalties | ||||
Proceeds from sale of future royalties, net | $ 200,000 | 200,000 | ||
Effective annual interest rate | 10.50% | |||
Current effective interest rate | 12.2 | |||
IRH | Kadcyla | Maximum | ||||
Liability Related to Sale of Future Royalties | ||||
Royalties threshold | 260,000 | |||
IRH | Kadcyla | Minimum | ||||
Liability Related to Sale of Future Royalties | ||||
Royalties threshold | $ 235,000 | |||
OMERS | Kadcyla | ||||
Liability Related to Sale of Future Royalties | ||||
Percentage of royalty payments | 100% | |||
Non-cash royalty revenue related to the sale of future royalties | $ 65,200 | 12,500 | ||
Contingent broker fees | 1,500 | |||
Net proceeds from sale of residual rights to receive royalty payments | $ 65,200 | $ 9,400 | ||
Roche | ||||
Liability Related to Sale of Future Royalties | ||||
Period in arrears to receive royalty reports and payments related to sales of kadcyla | 3 months | |||
Roche | Kadcyla | ||||
Liability Related to Sale of Future Royalties | ||||
Non-cash royalty revenue related to the sale of future royalties | $ 17,900 | $ 21,500 |
Senior Secured Term Loan (Detai
Senior Secured Term Loan (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Apr. 06, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | |
Debt Instrument [Line Items] | |||
Lenders fee and deal expenses | $ 3,200 | ||
Net proceeds from the term loan | $ 71,800 | ||
Interest expense | $ 2,500 | $ 4,900 | |
Facility fee | 1,000 | ||
SOFR | |||
Debt Instrument [Line Items] | |||
Interest rate (as a percent) | 2.75% | ||
Plus per annum | 8% | ||
Senior Secured Term Loan, Tranche One [Member] | |||
Debt Instrument [Line Items] | |||
Senior secured term loan | $ 75,000 | ||
Secured Debt [Member] | |||
Debt Instrument [Line Items] | |||
Senior secured term loan | 175,000 | ||
Secured Debt [Member] | Senior Secured Term Loan, Tranche One [Member] | |||
Debt Instrument [Line Items] | |||
Senior secured term loan | 75,000 | 75,000 | |
Secured Debt [Member] | Senior Secured Term Loan, Tranche Two [Member] | Minimum | |||
Debt Instrument [Line Items] | |||
Senior secured term loan | 50,000 | $ 50,000 | $ 50,000 |
Secured Debt [Member] | Senior Secured Term Loan, Tranche Two [Member] | Maximum | |||
Debt Instrument [Line Items] | |||
Senior secured term loan | $ 100,000 |
Senior Secured Term Loan - Carr
Senior Secured Term Loan - Carrying value of term loan (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Apr. 06, 2023 | |
Debt Instrument [Line Items] | ||
Debt discount and issuance costs, unamortized | $ (2,887) | |
Term loan, net | 72,113 | |
Senior Secured Term Loan, Tranche One [Member] | ||
Debt Instrument [Line Items] | ||
Senior secured term loan | $ 75,000 | |
Secured Debt [Member] | ||
Debt Instrument [Line Items] | ||
Senior secured term loan | $ 175,000 | |
Secured Debt [Member] | Senior Secured Term Loan, Tranche One [Member] | ||
Debt Instrument [Line Items] | ||
Senior secured term loan | $ 75,000 |
Income Taxes - Loss before prov
Income Taxes - Loss before provision for income taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Reconciliation of the expected statutory tax benefit to the actual income taxes | ||||
Loss before income tax expense | $ 29,582 | $ (77,755) | $ (14,803) | $ (163,921) |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Income Tax Uncertainties | ||
Capitalize research and development amortization period | 5 years | |
Capitalize research and experimentation expenses, amortization period | 15 years | |
Income tax expense | $ (1.2) | $ 0.8 |
Capital Stock (Details)
Capital Stock (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
May 01, 2023 $ / shares shares | Jun. 30, 2023 shares | Sep. 30, 2023 $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) shares | Dec. 31, 2022 shares | Dec. 31, 2021 $ / shares shares | Aug. 11, 2021 | Jun. 30, 2018 shares | |
Stock-based compensation disclosure | |||||||||
Proceeds from issuance of common stock under stock plans | $ | $ 47,111 | $ 1,480 | |||||||
Common stock, issued shares | 265,842,000 | 265,842,000 | 226,046,000 | ||||||
Stock received in exchange | 21,853,000 | 21,853,000 | |||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||||
Conversion of stock ratio | 1,000 | ||||||||
Conversion Blocker | 9.99 | 9.99 | |||||||
Maximum amount of increase or decrease to Conversion Blocker | 19.99 | 19.99 | |||||||
Liquidation preference per share | $ / shares | $ 0.001 | $ 0.001 | |||||||
ESPP | |||||||||
Stock-based compensation disclosure | |||||||||
Aggregate number of common shares reserved for future issuance | 2,000,000 | ||||||||
Series A Convertible Preferred Stock | |||||||||
Stock-based compensation disclosure | |||||||||
Stock exchanged | 21,853 | ||||||||
Common Stock | |||||||||
Stock-based compensation disclosure | |||||||||
Stock received in exchange | 21,853,000 | ||||||||
Pre-Funded Warrants | |||||||||
Stock-based compensation disclosure | |||||||||
Warrant exercise price | $ / shares | $ 0.01 | ||||||||
Threshold percentage of common stock owned that limits the number of warrants exercised | 9.99 | ||||||||
Maximum percentage of increase or decrease to amount of common stock owned | 19.99 | ||||||||
RA Capital Healthcare Fund, L.P. | Pre-Funded Warrants | |||||||||
Stock-based compensation disclosure | |||||||||
Warrants exercised (in shares) | 11,000,000 | ||||||||
RA Capital Healthcare Fund, L.P. | Pre-Funded Warrants | Common Stock | |||||||||
Stock-based compensation disclosure | |||||||||
Common stock, issued shares | 10,992,330 | 10,992,330 | |||||||
Redmile Group LLC | Pre-Funded Warrants | |||||||||
Stock-based compensation disclosure | |||||||||
Warrants exercised (in shares) | 11,357,272 | ||||||||
Stock options | |||||||||
Stock-based compensation disclosure | |||||||||
Stock options granted to directors (in shares) | 6,316,000 | ||||||||
Options exercised (in shares) | 9,121,000 | ||||||||
Securities Purchase Agreement | RA Capital Healthcare Fund, L.P. | Pre-Funded Warrants | |||||||||
Stock-based compensation disclosure | |||||||||
Pre-Funded warrants issued to purchase shares | 21,434,872 | 21,434,872 | 21,434,782 | ||||||
Securities Purchase Agreement | Redmile Group LLC | Pre-Funded Warrants | |||||||||
Stock-based compensation disclosure | |||||||||
Pre-Funded warrants issued to purchase shares | 11,363,636 | ||||||||
Compensation Policy for Non-Employee Directors | Common Stock | |||||||||
Stock-based compensation disclosure | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 14,112 | ||||||||
Compensation Policy for Non-Employee Directors | Stock options | |||||||||
Stock-based compensation disclosure | |||||||||
Stock options granted to directors (in shares) | 157,000 | 322,000 | |||||||
Compensation Policy for Non-Employee Directors | Restricted stock units | |||||||||
Stock-based compensation disclosure | |||||||||
Stock options granted to directors (in shares) | 105,000 |
Leases (Details)
Leases (Details) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2023 USD ($) ft² lease | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Lessee, Lease, Description [Line Items] | |||
Number of real estate leases | lease | 1 | ||
Right-of-use assets | $ | $ 8,338 | $ 10,231 | |
Sublease income | $ | $ 2,300 | $ 2,400 | |
830 Winter Street, Waltham, MA | |||
Lessee, Lease, Description [Line Items] | |||
Area of space leased | ft² | 120,000 | ||
Number of executed sub-lease spaces | lease | 4 | ||
Area of executed sublease space | ft² | 65,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborations and Manufacturing Commitments | ||||
Research and development | $ 47,570 | $ 59,181 | $ 149,267 | $ 154,885 |
In-process and future manufacturing of antibody, drug substance, and cytotoxic agents | ||||
Collaborations and Manufacturing Commitments | ||||
Noncancelable obligations under several agreements | 45,300 | 45,300 | ||
Minimum | ||||
Collaborations and Manufacturing Commitments | ||||
Manufacturing commitment | $ 47,300 | $ 47,300 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
May 31, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | May 01, 2023 | |
Related Party Transaction | |||||
Stock received in exchange | 21,853,000 | 21,853,000 | |||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | |||
Related Party [Member] | RA Capital Healthcare Fund, L.P. | |||||
Related Party Transaction | |||||
Stock received in exchange | 21,853,000 | ||||
Stock exchanged | 21,853 | ||||
Related Party [Member] | Ergomed PLC [Member] | |||||
Related Party Transaction | |||||
Payments to related party | $ 4.8 | $ 3.9 | |||
Related Party [Member] | PrimeVigilance USA, Inc [Member] | |||||
Related Party Transaction | |||||
Payments to related party | $ 1.1 | $ 0.2 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands | Apr. 06, 2023 | Sep. 30, 2023 |
SOFR | ||
Subsequent Event [Line Items] | ||
Interest rate (as a percent) | 2.75% | |
Plus per annum | 8% | |
Senior Secured Term Loan, Tranche One [Member] | ||
Subsequent Event [Line Items] | ||
Senior secured term loan | $ 75,000 | |
Secured Debt [Member] | ||
Subsequent Event [Line Items] | ||
Senior secured term loan | 175,000 | |
Secured Debt [Member] | Senior Secured Term Loan, Tranche One [Member] | ||
Subsequent Event [Line Items] | ||
Senior secured term loan | $ 75,000 | |
Secured Debt [Member] | Senior Secured Term Loan, Tranche Two [Member] | Minimum | ||
Subsequent Event [Line Items] | ||
Senior secured term loan | 50,000 | $ 50,000 |
Secured Debt [Member] | Senior Secured Term Loan, Tranche Two [Member] | Maximum | ||
Subsequent Event [Line Items] | ||
Senior secured term loan | $ 100,000 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | |||||||||
Net Income (Loss) | $ 30,748 | $ (4,248) | $ (41,014) | $ (59,008) | $ (77,755) | $ (62,021) | $ (24,145) | $ (14,514) | $ (163,921) |
Insider Trading Arrangements
Insider Trading Arrangements - shares | 3 Months Ended | |||
Aug. 10, 2023 | Aug. 04, 2023 | Jun. 08, 2023 | Sep. 30, 2023 | |
Rule10b5-1 Trading Plan | Anna Berkenblit | ||||
Trading Arrangements, by Individual | ||||
Name | Dr. Anna Berkenblit | |||
Title | Senior Vice President, Chief Medical Officer | |||
Adoption Date | June 8, 2023 | |||
Rule 10b5-1 Arrangement Terminated | true | |||
Termination Date | August 4, 2023 | |||
Rule10b5-1 Trading Plan | Stacy A Coen | ||||
Trading Arrangements, by Individual | ||||
Name | Ms. Stacy A. Coen | |||
Title | Senior Vice President, Chief Business Officer | |||
Rule 10b5-1 Arrangement Adopted | true | |||
Adoption Date | August 10, 2023 | |||
Aggregate Available | 219,185 | |||
Separate Rule10b5-1 Trading Plan | Anna Berkenblit | ||||
Trading Arrangements, by Individual | ||||
Name | Dr. Anna Berkenblit | |||
Adoption Date | June 8, 2023 | |||
Rule 10b5-1 Arrangement Terminated | true | |||
Termination Date | August 4, 2023 | |||
Aggregate Available | 1,172,876 |