Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 08, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-35006 | |
Entity Registrant Name | SPECTRUM PHARMACEUTICALS INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 93-0979187 | |
Entity Address, Address Line One | 11500 South Eastern Avenue | |
Entity Address, Address Line Two | Suite 220 | |
Entity Address, City or Town | Henderson | |
Entity Address, State or Province | NV | |
Entity Address, Postal Zip Code | 89052 | |
City Area Code | 702 | |
Local Phone Number | 835-6300 | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Trading Symbol | SPPI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 163,956,341 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0000831547 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 107,435 | $ 46,009 |
Marketable securities | 26,160 | 134,016 |
Accounts receivable, net | 0 | 67 |
Other receivables | 3,863 | 2,394 |
Prepaid expenses and other current assets | 2,540 | 4,161 |
Total current assets | 139,998 | 186,647 |
Property and equipment, net | 507 | 3,577 |
Facility and equipment under lease | 2,881 | 2,247 |
Other assets | 4,415 | 4,327 |
Total assets | 147,801 | 196,798 |
Current liabilities: | ||
Accounts payable and other accrued liabilities | 48,982 | 43,771 |
Accrued payroll and benefits | 8,290 | 9,375 |
Total current liabilities | 57,272 | 53,146 |
Other long-term liabilities | 11,065 | 9,409 |
Total liabilities | 68,337 | 62,555 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value; 300,000,000 shares authorized; 163,957,900 and 146,083,110 issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 164 | 146 |
Additional paid-in capital | 1,086,989 | 1,021,221 |
Accumulated other comprehensive loss | (3,481) | (1,829) |
Accumulated deficit | (1,004,208) | (885,295) |
Total stockholders’ equity | 79,464 | 134,243 |
Total liabilities and stockholders’ equity | $ 147,801 | $ 196,798 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value ($ per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (shares) | 0 | 0 |
Preferred stock, shares outstanding (shares) | 0 | 0 |
Common stock, par value ($ per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (shares) | 163,957,900 | 146,083,110 |
Common stock, shares outstanding (shares) | 163,957,900 | 146,083,110 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating costs and expenses: | ||||
Selling, general and administrative | $ 12,243 | $ 15,116 | $ 41,515 | $ 44,654 |
Research and development | 20,850 | 24,453 | 69,335 | 62,192 |
Total operating costs and expenses | 33,093 | 39,569 | 110,850 | 106,846 |
Loss from continuing operations before other income (expense) and income taxes | (33,093) | (39,569) | (110,850) | (106,846) |
Other income (expense): | ||||
Interest income, net | 11 | 188 | 121 | 1,217 |
Other income (expense), net | 9 | (9,131) | (7,948) | (15,720) |
Total other income (expense) | 20 | (8,943) | (7,827) | (14,503) |
Loss from continuing operations before income taxes | (33,073) | (48,512) | (118,677) | (121,349) |
Provision for income taxes from continuing operations | 0 | (6) | (9) | (15) |
Loss from continuing operations | (33,073) | (48,518) | (118,686) | (121,364) |
Income (loss) from discontinued operations, net of income taxes | (11) | 66 | (227) | 255 |
Net loss | $ (33,084) | $ (48,452) | $ (118,913) | $ (121,109) |
Basic and diluted loss per share: | ||||
Loss from continuing operations, basic ($ per share) | $ (0.21) | $ (0.37) | $ (0.77) | $ (1.02) |
Loss from continuing operations, diluted ($ per share) | (0.21) | (0.37) | (0.77) | (1.02) |
Income (loss) from discontinued operations, basic ($ per share) | 0 | 0 | 0 | 0 |
Income (loss) from discontinued operations, diluted ($ per share) | 0 | 0 | 0 | 0 |
Net loss per share, basic ($ per share) | (0.21) | (0.37) | (0.78) | (1.02) |
Net loss per share, diluted ($ per share) | $ (0.21) | $ (0.37) | $ (0.78) | $ (1.02) |
Weighted average shares outstanding, basic (shares) | 159,261,818 | 131,455,727 | 153,341,854 | 118,664,914 |
Weighted average shares outstanding, diluted (shares) | 159,261,818 | 131,455,727 | 153,341,854 | 118,664,914 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (33,084) | $ (48,452) | $ (118,913) | $ (121,109) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities, net of tax | (1) | 73 | (1,130) | (61) |
Foreign currency translation adjustments | (153) | 457 | (522) | 835 |
Other comprehensive income (loss) | (154) | 530 | (1,652) | 774 |
Total comprehensive loss | $ (33,238) | $ (47,922) | $ (120,565) | $ (120,335) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Public offering | At-the-market sales offering | Common Stock | Common StockPublic offering | Common StockAt-the-market sales offering | Additional Paid-In Capital | Additional Paid-In CapitalPublic offering | Additional Paid-In CapitalAt-the-market sales offering | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2019 | 113,299,612 | ||||||||||
Beginning Balance at Dec. 31, 2019 | $ 190,393 | $ 113 | $ 918,205 | $ (3,498) | $ (724,427) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (40,572) | (40,572) | |||||||||
Other comprehensive loss, net | (1,329) | (1,329) | |||||||||
Recognition of stock-based compensation expense | 5,010 | 5,010 | |||||||||
Issuance of common stock to 401(k) plan for employees (in shares) | 96,959 | ||||||||||
Issuance of common stock to 401(k) plan for employees | 265 | 265 | |||||||||
Restricted stock award grants, net of forfeitures (in shares) | 1,377,508 | ||||||||||
Restricted stock award grants, net of forfeitures | 1 | $ 1 | |||||||||
Ending Balance (in shares) at Mar. 31, 2020 | 114,774,079 | ||||||||||
Ending Balance at Mar. 31, 2020 | 153,768 | $ 114 | 923,480 | (4,827) | (764,999) | ||||||
Beginning Balance (in shares) at Dec. 31, 2019 | 113,299,612 | ||||||||||
Beginning Balance at Dec. 31, 2019 | 190,393 | $ 113 | 918,205 | (3,498) | (724,427) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (121,109) | ||||||||||
Ending Balance (in shares) at Sep. 30, 2020 | 145,931,172 | ||||||||||
Ending Balance at Sep. 30, 2020 | 168,360 | $ 146 | 1,016,474 | (2,724) | (845,536) | ||||||
Beginning Balance (in shares) at Dec. 31, 2019 | 113,299,612 | ||||||||||
Beginning Balance at Dec. 31, 2019 | $ 190,393 | $ 113 | 918,205 | (3,498) | (724,427) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Issuance of common shares under an at-the-market sales agreement (in shares) | 3,950,398 | ||||||||||
Ending Balance (in shares) at Dec. 31, 2020 | 146,083,110 | ||||||||||
Ending Balance at Dec. 31, 2020 | $ 134,243 | $ 146 | 1,021,221 | (1,829) | (885,295) | ||||||
Beginning Balance (in shares) at Mar. 31, 2020 | 114,774,079 | ||||||||||
Beginning Balance at Mar. 31, 2020 | 153,768 | $ 114 | 923,480 | (4,827) | (764,999) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (32,085) | (32,085) | |||||||||
Other comprehensive loss, net | 1,573 | 1,573 | |||||||||
Recognition of stock-based compensation expense | 3,988 | 3,988 | |||||||||
Issuance of common shares under an at-the-market sales agreement (in shares) | 1,024,286 | ||||||||||
Issuance of common shares under an at-the-market sales agreement | 3,071 | $ 1 | 3,070 | ||||||||
Issuance of common stock for employee stock purchase plan (shares) | 98,362 | ||||||||||
Issuance of common stock for employee stock purchase plan | 282 | 282 | |||||||||
Restricted stock award grants, net of forfeitures (in shares) | 1,926,385 | ||||||||||
Restricted stock award grants, net of forfeitures | $ 3 | (3) | |||||||||
Issuance of common stock upon vesting of restricted stock units (shares) | 861 | ||||||||||
Ending Balance (in shares) at Jun. 30, 2020 | 117,823,973 | ||||||||||
Ending Balance at Jun. 30, 2020 | 130,597 | $ 118 | 930,817 | (3,254) | (797,084) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (48,452) | (48,452) | |||||||||
Other comprehensive loss, net | 530 | 530 | |||||||||
Recognition of stock-based compensation expense | 4,108 | 4,108 | |||||||||
Issuance of common shares under an at-the-market sales agreement (in shares) | 24,916,667 | 2,926,112 | |||||||||
Issuance of common shares under an at-the-market sales agreement | $ 69,733 | $ 11,831 | $ 69,708 | $ 11,828 | |||||||
Issuance of common stock upon exercise of stock options (in shares) | 3,542 | ||||||||||
Issuance of common stock upon exercise of stock options | 13 | 13 | |||||||||
Restricted stock award grants, net of forfeitures (in shares) | 260,878 | ||||||||||
Ending Balance (in shares) at Sep. 30, 2020 | 145,931,172 | ||||||||||
Ending Balance at Sep. 30, 2020 | 168,360 | $ 146 | 1,016,474 | (2,724) | (845,536) | ||||||
Beginning Balance (in shares) at Dec. 31, 2020 | 146,083,110 | ||||||||||
Beginning Balance at Dec. 31, 2020 | 134,243 | $ 146 | 1,021,221 | (1,829) | (885,295) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (35,697) | (35,697) | |||||||||
Other comprehensive loss, net | (1,678) | (1,678) | |||||||||
Recognition of stock-based compensation expense | $ 4,212 | 4,212 | |||||||||
Issuance of common shares under an at-the-market sales agreement (in shares) | 5,678,893 | 5,678,893 | |||||||||
Issuance of common shares under an at-the-market sales agreement | $ 21,357 | $ 6 | 21,351 | ||||||||
Restricted stock award grants, net of forfeitures (in shares) | 1,966,333 | ||||||||||
Restricted stock award grants, net of forfeitures | 2 | $ 2 | |||||||||
Ending Balance (in shares) at Mar. 31, 2021 | 153,728,336 | ||||||||||
Ending Balance at Mar. 31, 2021 | 122,439 | $ 154 | 1,046,784 | (3,507) | (920,992) | ||||||
Beginning Balance (in shares) at Dec. 31, 2020 | 146,083,110 | ||||||||||
Beginning Balance at Dec. 31, 2020 | 134,243 | $ 146 | 1,021,221 | (1,829) | (885,295) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (118,913) | ||||||||||
Ending Balance (in shares) at Sep. 30, 2021 | 163,957,900 | ||||||||||
Ending Balance at Sep. 30, 2021 | 79,464 | $ 164 | 1,086,989 | (3,481) | (1,004,208) | ||||||
Beginning Balance (in shares) at Mar. 31, 2021 | 153,728,336 | ||||||||||
Beginning Balance at Mar. 31, 2021 | 122,439 | $ 154 | 1,046,784 | (3,507) | (920,992) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (50,132) | (50,132) | |||||||||
Other comprehensive loss, net | 180 | 180 | |||||||||
Recognition of stock-based compensation expense | $ 4,360 | 4,360 | |||||||||
Issuance of common shares under an at-the-market sales agreement (in shares) | 10,172,498 | 10,172,498 | |||||||||
Issuance of common shares under an at-the-market sales agreement | $ 31,265 | $ 10 | 31,255 | ||||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,250 | ||||||||||
Issuance of common stock upon exercise of stock options | 2 | 2 | |||||||||
Issuance of common stock for employee stock purchase plan (shares) | 163,463 | ||||||||||
Issuance of common stock for employee stock purchase plan | 474 | 474 | |||||||||
Restricted stock award grants, net of forfeitures (in shares) | 39,127 | ||||||||||
Issuance of common stock upon vesting of restricted stock units (shares) | 1,386 | ||||||||||
Ending Balance (in shares) at Jun. 30, 2021 | 164,106,060 | ||||||||||
Ending Balance at Jun. 30, 2021 | 108,588 | $ 164 | 1,082,875 | (3,327) | (971,124) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (33,084) | (33,084) | |||||||||
Other comprehensive loss, net | (154) | (154) | |||||||||
Recognition of stock-based compensation expense | $ 4,114 | 4,114 | |||||||||
Issuance of common shares under an at-the-market sales agreement (in shares) | 0 | ||||||||||
Issuance of common shares under an at-the-market sales agreement | $ 25 | $ 3 | |||||||||
Restricted stock award grants, net of forfeitures (in shares) | (148,160) | ||||||||||
Ending Balance (in shares) at Sep. 30, 2021 | 163,957,900 | ||||||||||
Ending Balance at Sep. 30, 2021 | $ 79,464 | $ 164 | $ 1,086,989 | $ (3,481) | $ (1,004,208) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash Flows From Operating Activities: | ||||||||
Loss from continuing operations | $ (33,073) | $ (48,518) | $ (118,686) | $ (121,364) | ||||
Income (loss) from discontinued operations, net of income taxes | (11) | 66 | (227) | 255 | ||||
Net loss | (33,084) | $ (35,697) | (48,452) | $ (40,572) | (118,913) | (121,109) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 212 | (105) | ||||||
Stock-based compensation | 12,686 | 13,371 | ||||||
Loss on disposal of manufacturing equipment | 2,900 | 3,057 | 0 | |||||
Non-cash lease expense | 1,151 | 1,148 | ||||||
Other non-cash items | 281 | 585 | ||||||
Realized gain on sale of equity holdings | (4,580) | (678) | ||||||
Unrealized loss on equity holdings | 12,816 | 16,029 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable, net | 66 | 1 | ||||||
Other receivables | (1,391) | 6,370 | ||||||
Prepaid expenses and other current assets | 1,620 | (2,663) | ||||||
Other assets | (89) | 6 | ||||||
Accounts payable and other accrued liabilities | 4,376 | 426 | ||||||
Accrued payroll and benefits | (1,085) | 427 | ||||||
Other long-term liabilities | 654 | (2,134) | ||||||
Net cash used in operating activities | (89,139) | (88,326) | ||||||
Cash Flows From Investing Activities: | ||||||||
Proceeds from maturities of investments | 109,771 | 94,929 | ||||||
Proceeds from sale of equity holdings | 4,406 | 1,843 | ||||||
Purchases of investments | (16,568) | (73,581) | ||||||
Purchases of property and equipment, net | (140) | (6,991) | ||||||
Net cash provided by investing activities | 97,469 | 16,200 | ||||||
Cash Flows From Financing Activities: | ||||||||
Proceeds from sale of common stock under an at-the-market sales agreement, net | 0 | 21,357 | $ 14,902 | $ 1,814 | ||||
Proceeds from sale of stock under our employee stock purchase plan | 474 | 283 | ||||||
Proceeds from employees for exercises of stock options | 4 | 13 | ||||||
Net cash provided by financing activities | 53,100 | 84,931 | ||||||
Effect of exchange rates on cash and cash equivalents | (4) | (91) | ||||||
Net increase in cash and cash equivalents | 61,426 | 12,714 | ||||||
Cash and cash equivalents—beginning of period | $ 46,009 | $ 64,418 | 46,009 | 64,418 | 64,418 | |||
Cash and cash equivalents—end of period | $ 107,435 | $ 77,132 | 107,435 | 77,132 | $ 46,009 | $ 64,418 | ||
Supplemental disclosure of cash flow information: | ||||||||
Cash paid for facility and equipment under operating leases | 1,626 | 1,805 | ||||||
Cash paid for income taxes | 12 | 14 | ||||||
Noncash investing activities: | ||||||||
Additions of property and equipment that remain in accounts payable and other accrued liabilities | 0 | 6,017 | ||||||
Public offering | ||||||||
Cash Flows From Financing Activities: | ||||||||
Proceeds from sale of common stock under an at-the-market sales agreement, net | 0 | 69,733 | ||||||
At-the-market sales agreement, net | ||||||||
Cash Flows From Financing Activities: | ||||||||
Proceeds from sale of common stock under an at-the-market sales agreement, net | $ 52,622 | $ 14,902 |
Description of Business, Basis
Description of Business, Basis of Presentation, and Operating Segment | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business, Basis of Presentation, and Operating Segment | Description of Business, Basis of Presentation, And Operating Segment (a) Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharmaceutical company, with a primary strategy comprised of acquiring, developing, and commercializing novel and targeted oncology therapies. Our in-house development organization includes clinical development, regulatory, quality and data management. We have three drugs in development: • ROLONTIS, a novel long-acting granulocyte colony-stimulating factor (“G-CSF”) for chemotherapy-induced neutropenia. We submitted a Biologics License Application (“BLA”) for ROLONTIS in December 2019, and in August 2021, we received a Complete Response Letter from the U.S. Food and Drug Administration (the “FDA”) regarding our Biologics License Application (“BLA”), citing deficiencies related to manufacturing and indicating that a reinspection will be necessary. We are currently working on remediating the manufacturing deficiencies and expect that this work will be complete in the fourth quarter of 2021 and plan to resubmit thereafter; • Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations. A New Drug Application (“NDA”) based on data from Cohort 2 of ZENITH20, which evaluated previously treated patients with NSCLC with HER2 exon 20 insertion mutation, is expected to be filed with the FDA in 2021; and • Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma patients. Our business strategy is the development of our late-stage assets through commercialization and the sourcing of additional assets that are synergistic with our existing portfolio (through purchase acquisitions, in-licensing transactions, or co-development and marketing arrangements). (b) Basis of Presentation Interim Financial Statements The interim financial data for the three and nine months ended September 30, 2021 and 2020 is unaudited and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the three and nine months ended September 30, 2021 and 2020. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. Certain prior period amounts have been reclassified for consistency with the current year presentation. The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included within our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (filed with the SEC on March 31, 2021). Discontinued Operations - Sale of our Commercial Product Portfolio In March 2019, we completed the sale of our seven then-commercialized drugs, including FUSILEV, KHAPZORY, FOLOTYN, ZEVALIN , MARQIBO, BELEODAQ, and EVOMELA (the “Commercial Product Portfolio”) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). Upon closing, we received $158.8 million in an upfront cash payment. We are also entitled to receive up to an aggregate of $140 million upon Acrotech's future achievement of certain regulatory milestones (totaling $40 million) and sales-based milestones (totaling $100 million) relating to the Commercial Product Portfolio. Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with GAAP and with the rules and regulations of the SEC. These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. Substantially all of the accumulated other comprehensive loss is comprised of foreign currency translation adjustments at September 30, 2021. Liquidity and Capital Resources We believe that our $133.6 million in aggregate cash, cash equivalents and marketable securities as of September 30, 2021, are sufficient to fund our current and planned operations for at least the next twelve months. We may however, require additional liquidity as we continue to execute our business strategy, and in connection with opportunistic acquisitions or licensing arrangements. We anticipate that to the extent that we require additional liquidity, it will be funded through additional equity or debt financings, or out-licensing arrangements. However, we cannot provide assurance that we will be able to obtain this additional liquidity on terms favorable to us or our current stockholders, if at all. Additionally, our liquidity and our ability to fund our capital requirements are also dependent on our future financial performance which is subject to various market and economic factors that are beyond our control. (c) Operating Segment |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Use of Estimates | Summary of Significant Accounting Policies And Use of Estimates The preparation of financial statements in conformity with GAAP requires our management to make informed estimates and assumptions that affect our reported amounts of assets, liabilities, revenues, and expenses. These amounts may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. On an on-going basis, our management evaluates (as applicable) its most critical estimates and assumptions, including those related to: (i) the realization of our tax assets and estimates of our tax liabilities; (ii) the fair value of our investments; (iii) the valuation of our stock options and the periodic expense recognition of stock-based compensation; and (iv) the potential outcome of our ongoing or threatened litigation. Our accounting policies and estimates that most significantly impact the presented amounts within these Condensed Consolidated Financial Statements are further described below: (i) Revenue Recognition In March 2019, we completed the Commercial Product Portfolio Transaction. In accordance with applicable GAAP ( ASC 205-20, Presentation of Financial Statements ), the revenue-deriving activities of our sold commercial operation are separately classified as “discontinued” for all periods presented within the accompanying Condensed Consolidated Statements of Operations. Required Elements of Our Revenue Recognition : Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under Accounting Standards Update (“ ASU ”) No. 2014-09 , Revenue from Contracts with Customers ( “Topic 606” ) in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements: (1) we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable; (2) we identify the “performance obligations” in the respective contract; (3) we determine the “transaction price” for each performance obligation in the respective contract; (4) we allocate the transaction price to each performance obligation; and (5) we recognize revenue only when we satisfy each performance obligation. These five elements, as applied to each of our revenue categories, are summarized below: (a) Product Sales : We sell our products to pharmaceutical wholesalers/distributors or to our product licensees (i.e., our customers). Our wholesalers/distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration. Our gross product sales (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in reported “product sales, net” that reflects the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and group purchasing organization (“GPO”) administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales. These GTN estimate categories (that comprise our GTN liabilities) are each discussed below: Product Returns Allowances : Our customers are contractually permitted to return certain purchased products within the contractual allowable time before/after the applicable expiration date. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns using our historical return rates. Returned product is typically destroyed since substantially all are due to imminent expiry and cannot be resold. Government Chargebacks : Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers. Prompt Pay Discounts : Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage. Commercial Rebates : Commercial rebates are based on (i) our estimates of end-user purchases through a GPO, (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us. Medicaid Rebates : Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in our receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment. Distribution, Data, and GPO Administrative Fees : Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products for various commercial services including: contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales. (b) License Fees : Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (i) upfront license fees, (ii) sales royalties, (iii) sales milestone-achievement fees, and (iv) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows: (1) Upfront License Fees: We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer). (2) Royalties : Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt. (3) Sales Milestones : Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt. (4) Regulatory Milestones : Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee. • When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” (i.e., not recognized) until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. • When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. (c) Service Revenue : We receive fees under certain arrangements for (i) sales and marketing services, (ii) supply chain services, (iii) research and development services, and (iv) clinical trial management services. Our rights to receive payment for these services may be established by (1) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (2) our completion of product delivery in our capacity as a procurement agent, (3) the successful completion of a phase of drug development, (4) favorable results from a clinical trial, and/or (5) regulatory approval events. We consider whether revenue associated with these service arrangements is reportable each period, based on our completed services or deliverables (i.e., satisfied “performance obligations”) during the reporting period, and the terms of the arrangement that contractually result in fixed payments due to us. The promised service(s) within these arrangements are distinct and explicitly stated within each contract, and our customer benefits from the separable service(s) delivery/completion. Further, the nature of the promise to our customer as stated within the respective contract is to deliver each named service individually (not a transfer of combined items to which the promised goods or services are inputs), and thus are separable for revenue recognition. (ii) Cash and Cash Equivalents Cash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. (iii) Marketable Securities Marketable securities consist of our holdings in equity securities (including mutual funds), bank CDs, government-related debt securities, and corporate debt securities. For equity securities and mutual funds, any realized gains (losses) or unrealized gains (losses) are recognized in “other income (expense), net” within the Condensed Consolidated Statements of Operations. Debt securities and bank CDs are classified as “available-for-sale” investments and (1) realized gains (losses) are recognized in “other income (expense), net” within the Condensed Consolidated Statements of Operations and (2) unrealized gains (losses) are recognized as a component of “accumulated other comprehensive loss” within the Condensed Consolidated Statements of Stockholders’ Equity. (iv) Accounts Receivable, Net Our accounts receivable, net of allowance for credit losses, are derived from our product sales and license fees, and do not bear interest. The allowance for credit losses is management’s best estimate of the amount of expected credit losses in our existing accounts receivable and any anticipated discounts. The allowance for credit losses is adjusted each period through earnings to reflect expected credit losses over the remaining life of the asset. Account balances are written off against the allowance after appropriate collection efforts are exhausted. (v) Inventories We value our inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its net realizable value, which takes into account our sales forecast by product and corresponding expiry dates of each product lot. Manufacturing costs of drug products that are pending FDA approval during clinical development and trials, and at-risk inventory build in anticipation of commercialization, are exclusively recognized through “research and development” expense on the accompanying Condensed Consolidated Statements of Operations. (vi) Property and Equipment, Net Our property and equipment, net is stated at historical cost, and is depreciated on a straight-line basis over an estimated useful life that corresponds with its designated asset category. We evaluate the recoverability of “long-lived assets” (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable. Recoverability is measured by a comparison of the carrying amount to the net undiscounted cash flows expected to be generated by the asset group. An impairment loss would be recorded for the excess of net carrying value over the fair value of the asset impaired. The fair value is estimated based on expected discounted future cash flows or other methods such as orderly liquidation value based on assumptions of asset class and observed market data. An orderly liquidation value is the amount that could be realized upon liquidation, given a sufficient amount of time to find a purchaser for a sale of assets in their existing condition and location, as of a specific date, and assuming the sale is to market participants who can utilize such assets in their highest and best use. The orderly liquidation values are applied against the carrying values of the assets and the impairment loss is measured as the difference between the liquidation value and the carrying value of the assets. See Note 4(d) for further discussion related to an impairment that occurred during the year ended December 31, 2020. (vii) Stock-Based Compensation Stock-based compensation expense for equity awards granted to our employees and members of our Board of Directors is recognized on a straight-line basis over each award’s vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited prior to vesting, though is ultimately adjusted for actual forfeitures. We use the Black-Scholes option pricing model to determine the fair value of stock options and stock appreciation rights (as of the date of grant) that have service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) that have combined market conditions and service conditions for vesting. The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term that the stock option will remain outstanding, (c) our stock price volatility over the expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the prevailing risk-free interest rate for the period matching the expected term. With regard to (a)-(d) above: we estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on the historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option. (viii) Basic and Diluted Net Loss per Share We calculate basic and diluted net loss per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only stock options, warrants, and other common stock equivalents outstanding during the period to the extent that they are dilutive. There were 12,708,185 shares and 9,648,862 shares of outstanding securities (including stock options, restricted stock units, stock appreciation rights, and performance awards) as of September 30, 2021 and 2020, respectively, that were excluded from the calculation of diluted net loss per share because their inclusion would have been anti-dilutive. (ix) Income Taxes Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. We apply an estimated annual effective tax rate (“ETR”) approach for calculating a tax provision for interim periods. Our ETR differs from the U.S. federal statutory tax rate primarily as a result of nondeductible expenses and the impact of a valuation allowance on our deferred tax assets, which we record because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income in the period that such determination was made. In the event that we are assessed interest and/or penalties from taxing authorities that have not been previously accrued, such amounts would be included in “benefit for income taxes from continuing operations” within the accompanying Condensed Consolidated Statements of Operations for the period in which we received the notice. In March 2020, we elected to early adopt ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ,” which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. (x) Research and Development Expenses Our research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, benefits, and other staff-related costs including associated stock-based compensation, laboratory supplies, clinical trial and related clinical manufacturing costs, costs related to manufacturing preparations, fees paid to other entities that conduct certain research and development activities on our behalf and payments made pursuant to license agreements. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. We accrue for costs incurred as the services are being provided by monitoring the status of activities and the invoices received from our external service providers. We adjust our accruals as actual costs become known. Where contingent milestone payments are due to third parties under research and development or license agreements, the milestone payment obligations are expensed when the clinical or regulatory milestone results are achieved. (xi) Fair Value Measurements We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The table below summarizes certain asset and liability fair values that are included within our accompanying Condensed Consolidated Balance Sheets, and their designations among the three fair value measurement categories: September 30, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 92,172 $ — $ — $ 92,172 Equity securities 10,237 — — 10,237 Government-related debt securities 10,023 — — 10,023 Mutual funds 5,900 9 — 5,909 Key employee life insurance, cash surrender value (1) — 4,287 — 4,287 $ 118,332 $ 4,296 $ — $ 122,628 Liabilities: Deferred executive compensation liability (2) $ — $ 10,489 $ — $ 10,489 $ — $ 10,489 $ — $ 10,489 (1) Included within other assets on our Condensed Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $1.1 million within accounts payable and other accrued liabilities and $9.4 million within other long-term liabilities on our Condensed Consolidated Balance Sheets. The amounts are based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. December 31, 2020 Level 1 Level 2 Level 3 Total Assets: Government-related debt securities $ 92,928 $ — $ — $ 92,928 Corporate debt securities — 8,848 — 8,848 Money market funds 40,560 — — 40,560 Equity securities 24,946 — — 24,946 Bank CDs — 1,721 — 1,721 Mutual funds 5,573 9 — 5,582 Key employee life insurance, cash surrender value (1) — 3,963 — 3,963 $ 164,007 $ 14,541 $ — $ 178,548 Liabilities: Deferred executive compensation liability (2) $ — $ 9,783 $ — $ 9,783 $ — $ 9,783 $ — $ 9,783 (1) Included within other assets on our Condensed Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $1.3 million within accounts payable and other accrued liabilities and $8.5 million within other long-term liabilities on our Condensed Consolidated Balance Sheets. The amounts are based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. We did not have any transfers between “Level 1” and “Level 2” measurement categories for any periods presented. |
Balance Sheet Account Detail
Balance Sheet Account Detail | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Account Detail | Balance Sheet Account Detail The composition of selected financial statement captions that comprise the accompanying Condensed Consolidated Balance Sheets are summarized below: (a) Cash and Cash Equivalents and Marketable Securities We maintain cash balances with select major financial institutions. The Federal Deposit Insurance Corporation (FDIC) and other third parties insure a fraction of these deposits. Accordingly, these cash deposits are not insured against the possibility of a substantial or complete loss of principal and are inherently subject to the credit risk of the corresponding financial institution. There were no material unrealized losses on our investment securities at September 30, 2021 or December 31, 2020. Our investment policy requires that purchased investments may only be in highly-rated and liquid financial instruments and limits our holdings of any single issuer (excluding any debt or equity securities that may be received from our strategic partners in connection with an out-license arrangement). The carrying amount of our equity securities, money market funds, and bank CDs approximates their fair value (utilizing “Level 1” or “Level 2” inputs) because of our ability to immediately convert these instruments into cash with minimal expected change in value. As of September 30, 2021, our held securities that remain in an unrealized loss position for less than one year were insignificant and are presented in the table below. The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Fair Cash and Cash Marketable September 30, 2021 Money market funds $ 92,172 $ 92,172 $ 92,172 $ — Equity securities (1) 3,528 10,237 — 10,237 Government-related debt securities 10,023 10,023 — 10,023 Mutual funds 4,753 5,900 — 5,900 Bank deposits 15,263 15,263 15,263 — Total cash and cash equivalents and marketable securities $ 125,739 $ 133,595 $ 107,435 $ 26,160 December 31, 2020 Money market funds $ 40,560 $ 40,560 $ 40,560 $ — Equity securities 3,764 24,946 — 24,946 Government-related debt securities 92,881 92,928 — 92,928 Corporate debt securities 8,846 8,848 — 8,848 Mutual funds 4,497 5,573 — 5,573 Bank CDs 1,715 1,721 — 1,721 Bank deposits 5,449 5,449 5,449 — Total cash and cash equivalents and marketable securities $ 157,712 $ 180,025 $ 46,009 $ 134,016 (1) Our aggregate equity holdings consist of 6.7 million common shares of CASI Pharmaceuticals, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $7.9 million as of September 30, 2021. We completed the sale of 1.8 million shares of common stock and recognized a $4.2 million gain within “other expense, net” within the accompanying Condensed Consolidated Statements of Operations for the nine months ended September 30, 2021. Additionally, we hold 0.8 million common shares of Unicycive Therapeutics, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $2.3 million as of September 30, 2021. (b) Other Receivables “Other receivables” consists of the following: September 30, 2021 December 31, 2020 Other miscellaneous receivables $ 2,443 $ 901 Income tax receivable - current portion 1,297 1,297 Interest receivable from marketable securities 123 196 Other receivables $ 3,863 $ 2,394 (c) Prepaid Expenses and Other Current Assets “Prepaid expenses and other current assets” consists of the following: September 30, 2021 December 31, 2020 Prepaid expenses and deferred costs $ 2,370 $ 1,996 Prepaid insurance 170 2,165 Prepaid expenses and other current assets $ 2,540 $ 4,161 (d) Property and Equipment, net “Property and equipment, net” consists of the following: September 30, 2021 December 31, 2020 Manufacturing equipment $ — $ 3,245 Computer hardware and software 1,802 1,680 Laboratory equipment 5 5 Leasehold improvements 1,267 1,267 Office furniture 307 248 Property and equipment, at cost 3,381 6,445 (Less): Accumulated depreciation (2,874) (2,868) Property and equipment, net $ 507 $ 3,577 Depreciation expense was immaterial for the three and nine months ended September 30, 2021 and 2020, respectively. Manufacturing equipment was comprised of our owned ROLONTIS production equipment on location at our contract manufacturer. As of December 31, 2020, we determined that we would no longer proceed with the technology transfer and validation of a second manufacturing source for ROLONTIS and communicated this decision to the second source manufacturer. We had invested significant capital to prepare this facility for production. Due to the decision to halt this work, we determined that the value of certain ROLONTIS production equipment had a carrying amount in excess of the anticipated recoverable value as there would be no future cash flows from these assets other than through the sale of this equipment. We determined the fair value of these assets under an orderly liquidation value method, and based on the valuation performed we recorded an impairment of $19.7 million to our carrying value for this equipment, which was recorded as research and development expense for the year ended December 31, 2020 within the Consolidated Statements of Operations. During the three months ended September 30, 2021, this equipment was surrendered in connection with the termination of our agreement with our second source manufacturer and we recorded incremental research and development expense of $2.9 million. Fair value was based on observable market data (“Level 2”). Due to the specialized nature of this production equipment, adjustments to observable market data were applied (“Level 3”). (e) Accounts Payable and Other Accrued Liabilities “Accounts payable and other accrued liabilities” consists of the following : September 30, 2021 December 31, 2020 Trade accounts payable and other $ 40,914 $ 34,385 Lease liability - current portion 1,451 1,544 Commercial Product Portfolio accruals (Note 7) 6,617 7,842 Accounts payable and other accrued liabilities $ 48,982 $ 43,771 Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed Consolidated Balance Sheets for our categories of GTN estimates related to the Commercial Product Portfolio accruals were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, Data, Inventory and Product Return Allowances Total Balance as of December 31, 2019 $ 14,671 $ 1,138 $ 4,714 $ 20,523 (Less): Payments and credits against GTN accruals (12,070) (196) (415) (12,681) Balance as of December 31, 2020 $ 2,601 $ 942 $ 4,299 $ 7,842 (Less): Payments and credits against GTN accruals (1,160) — (65) (1,225) Balance as of September 30, 2021 $ 1,441 $ 942 $ 4,234 $ 6,617 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation In June 2018, we adopted the 2018 Long-Term Incentive Plan, which provided for the issuance of restricted stock awards and units, incentive and nonqualified stock options, performance unit awards, stock appreciation rights, and other stock-based awards to employees, consultants and members of our Board of Directors. We report our stock-based compensation expense (inclusive of our incentive stock plan and employee stock purchase plan) in the accompanying Condensed Consolidated Statements of Operations within “total operating costs and expenses” for the three and nine months ended September 30, 2021 and 2020, as follows: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Selling, general and administrative $ 2,927 $ 3,018 $ 8,730 $ 9,773 Research and development 1,187 1,090 3,956 3,598 Total stock-based compensation $ 4,114 $ 4,108 $ 12,686 $ 13,371 We granted 3.5 million stock options with a weighted average exercise price of $3.65 during the nine months ended September 30, 2021. At September 30, 2021 we had 12.4 million options outstanding with a weighted average exercise price of $5.87. Additionally, we granted 2.4 million restricted stock awards with a weighted average grant date fair value of $3.62 during the nine |
Financial Commitments and Conti
Financial Commitments and Contingencies and Key License Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Financial Commitments and Contingencies and Key License Agreements | Financial Commitments and Contingencies and Key License Agreements (a) Facility and Equipment Leases Overview In the ordinary course of our business, we enter into leases with unaffiliated parties for the use of (i) office and research facilities and (ii) office equipment. Our current leases have remaining terms ranging from less than one We lease our principal executive office in Henderson, Nevada under a non-cancelable operating lease expiring October 31, 2021 which has been extended through October 31, 2022. We also lease our research and development facility in Irvine, California under a non-cancelable operating lease expiring July 31, 2022, in addition to other administrative office leases. We entered into a new office facility lease in Boston under a non-cancelable operating lease expiring in December 31, 2024. We recognize lease expense on a straight-line basis over the expected term of these operating leases, as reported within “selling, general and administrative” expense on the accompanying Condensed Consolidated Statements of Operations. Our facility leases have minimum annual rents, payable monthly, and some carry fixed annual rent increases. Under some of these arrangements, real estate taxes, insurance, certain operating expenses, and common area maintenance are reimbursable to the lessor. These amounts are expensed as incurred, as they are variable in nature and therefore excluded from the measurement of our reported lease asset and liability discussed below. As of September 30, 2021 and 2020, we had no sublease arrangements with us as lessor, and no finance leases, as defined in ASU 2016-02, Leases (“Topic 842”). The reported asset and liability, respectively, represents (i) the economic benefit of our use of leased facilities and equipment and (ii) the present-value of our contractual minimum lease payments, applying our estimated incremental borrowing rate as of the lease commencement date (since an implicit interest rate is not readily determinable in any of our leases). The recorded asset and liability associated with each lease is amortized over the respective lease term using the effective interest rate method. During the three and nine months ended September 30, 2021, we recognized $1.8 million of additional right-of-use assets in exchange for $1.8 million lease liabilities. We elected to not separate “lease components” from “non-lease components” in our measurement of minimum payments for our facility leases and office equipment leases. Additionally, we elected to not recognize a lease asset and liability for a term of 12 months or less. Financial Reporting Captions The below table summarizes the lease asset and liability accounts presented on our accompanying Condensed Consolidated Balance Sheets: Operating Leases Condensed Consolidated Balance Sheet Caption September 30, 2021 December 31, 2020 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 2,881 $ 2,247 Operating lease liabilities - current Accounts payable and other accrued liabilities 1,451 1,544 Operating lease liabilities - non-current Other long-term liabilities 1,593 883 Total operating lease liabilities $ 3,044 $ 2,427 As of September 30, 2021 and December 31, 2020, our “facility and equipment under lease” consisted of office and research facilities of $2.5 million and $1.9 million, respectively, and office equipment of $0.4 million and $0.3 million, respectively. Components of Lease Expense We recognize lease expense on a straight-line basis over the term of our operating leases, as reported within “selling, general and administrative” expense on the accompanying Condensed Consolidated Statements of Operations. The components of our aggregate lease expense is summarized below: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Operating lease cost $ 381 $ 466 $ 1,274 $ 1,398 Variable lease cost 79 86 280 314 Short-term lease cost 13 17 46 46 Total lease cost $ 473 $ 569 $ 1,600 $ 1,758 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of September 30, 2021 2.7 years 4.2% Operating leases as of December 31, 2020 1.6 years 7.8% Future Contractual Lease Payments The below table summarizes our (i) minimum lease payments over the next five years, (ii) lease arrangement implied interest, and (iii) present value of future lease payments: Operating Leases - future payments September 30, 2021 2021 (remaining) $ 382 2022 1,301 2023 657 2024 669 2025 98 2026 73 Total future lease payments, undiscounted $ 3,180 (Less): Implied interest (136) Present value of operating lease payments $ 3,044 (b) In/Out Licensing Agreements and Co-Development Arrangements Overview The in-license agreements for our development-stage drug products provide us with territory-specific rights to their manufacture and distribution (including further sub-licensing/out-licensing rights). We are generally responsible for all related clinical development costs, patent filings and maintenance costs, marketing costs, and liability insurance costs. We also may enter into out-license agreements for territory-specific rights to these drug products which include one or more of: upfront license fees, royalties from our licensees’ sales, and/or milestone payments from our licensees’ sales or regulatory achievements. For certain drug products, we may enter into cost-sharing arrangements with licensees and licensors. We are also obligated to make specified milestone payments to our licensors upon the achievement of certain regulatory and sales milestones, and to pay royalties based on our net sales of all in-licensed products. Depending on the milestone achievement type and whether the product has been approved, we will either (a) capitalize the value to “intangible assets” in the Consolidated Balance Sheets or (b) recognize the payment value within “research and development” or “cost of sales” on the Consolidated Statements of Operations. The liability relating to the payment due to the licensor will be recognized in the earliest period that we determine the respective milestone achievement is probable or occurs. Impact of Commercial Product Portfolio Transaction In March 2019, we completed the Commercial Product Portfolio Transaction and substantially all of the contractual rights and obligations associated with the Commercial Product Portfolio were transferred to Acrotech at the closing of the Commercial Product Portfolio Transaction. However, under the terms of this transaction we retained our trade “accounts receivable, net” and GTN liabilities included within “accounts payable and other accrued liabilities” associated with our product sales made on and prior to February 28, 2019. Accordingly, these Condensed Consolidated Financial Statements reflect the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations”. The most significant remaining agreements associated with our continuing operations are listed below, along with the key financial terms and our corresponding accounting and reporting conventions for each: (i) ROLONTIS: Co-Development and Commercialization Agreement with Hanmi In October 2014, we exercised our option under a License Option and Research Collaboration Agreement dated January 2012 (as amended) with Hanmi Pharmaceutical Co. Ltd. (“Hanmi”) for ROLONTIS, a drug based on Hanmi’s proprietary LAPSCOVERY™ technology for the treatment of chemotherapy induced neutropenia. Under the terms of this agreement, as amended, we have primary financial responsibility for the ROLONTIS development plan and hold its worldwide rights (except for Korea, China, and Japan). We are contractually obligated to pay Hanmi tiered royalties that range from the low double-digits to mid-teens on our annual net sales of ROLONTIS. We are responsible for regulatory milestone payments to Hanmi of $10 million upon approval of ROLONTIS, and sales milestone payments of up to $120 million per calendar year based on our annual net sales of ROLONTIS. (ii) Poziotinib: In-License Agreement with Hanmi and Exclusive Patent and Technology License Agreement with MD Anderson In February 2015, we executed an in-license agreement with Hanmi for poziotinib, a pan-HER inhibitor in Phase 2 clinical trials, (which has also shown single agent activity in the treatment of various cancer types during Phase 1 studies, including breast, gastric, colorectal, and lung cancers) and made an upfront payment to Hanmi for these distribution rights. Under the terms of this agreement, we received the exclusive global rights to commercialize poziotinib, except for Korea and China. Hanmi and its development partners are fully responsible for the completion of on-going Phase 2 trials in Korea. We are financially responsible for all other clinical studies. We are obligated to make contractual payments to Hanmi upon our achievement of various regulatory milestones that aggregate to $33 million. We are also obligated to pay Hanmi net sales milestones of up to $325 million annually and pay royalties in the low to mid-teen digits on our net sales of poziotinib, potentially reduced by royalties due to other third parties. In April 2018, we executed an exclusive patent and technology agreement for the use of poziotinib in treating patients with EGFR and HER2 exon 20 mutations in cancer and HER2 exon 19 mutations in cancer with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”). MD Anderson discovered poziotinib’s use in treating these patient-types. We made an upfront payment to MD Anderson of $0.5 million upon the execution of this agreement. We are contractually obligated to pay nominal fixed annual license maintenance fees to MD Anderson and pay additional fees upon our achievement of various regulatory and sales milestones. These regulatory milestones aggregate $6 million and the sales milestones aggregate $24 million. We are also contractually obligated to pay MD Anderson royalties in the low single-digits on our net sales of poziotinib. (iii) In-License Agreement with ImmunGene for FIT Drug Delivery Platform In April 2019, we executed an asset transfer, license, and sublicense agreement with ImmunGene, Inc. (“ImmunGene”) for an exclusive license for the intellectual property related to (a) Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma patients, representing a considerable unmet medical need, and (b) an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies that have the potential for treating both solid and hematologic malignancies. Both molecules are based on the Focused Interferon Therapeutics (“FIT”) drug delivery platform. We made upfront payments aggregating $2.8 million to ImmunGene and to several other third parties. We will make further payments to ImmunGene upon our achievement of various regulatory milestones that aggregate to $26.1 million, plus an additional $5 million milestone payment for each new indication (beyond those described above) approved for either drug in the U.S., Europe, or Japan. Our contractual royalties to ImmunGene are in the high-single digits on our net sales of each drug, potentially reduced by our royalties due to other third parties. We are also contractually obligated to pay nominal fixed annual license maintenance fees to two licensors. (iv) In-License Agreement with Therapyx In December 2020, we executed an asset transfer and license agreement with Therapyx, Inc. (“Therapyx”) for an exclusive worldwide license for the intellectual property related to any pharmaceutical or biological product for use in human oncology containing, whether as its sole active or in combination with other active ingredients, an encapsulated IL-12, in any injectable dosage form or formulation. We made an upfront payment of $0.8 million to Therapyx upon contract execution, which was recorded to “research and development” expense within our Consolidated Statements of Operations for the year ended December 31, 2020. We will make an additional payment of $2.2 million upon our acceptance of certain transferred materials from Therapyx. We will make further payments to Therapyx upon our achievement of various (i) regulatory milestones aggregating up to $30 million for the first approved IL-12 product, plus an additional $2.5 million milestone payment for each new indication approved for each product in the U.S., Europe, or Japan; and (ii) sales milestones aggregating up to $167.5 million based on worldwide annual net sales. We are contractually obligated to pay royalties in the mid-single digits on our net sales of all IL-12 products, potentially reduced by royalties due to third parties, the loss of IP protection within one or more countries, or the introduction of a competing product within one or more countries. Depending on the nature of the milestone achievement type we will either (a) capitalize the payment value to “intangible assets” in the Consolidated Balance Sheets or (b) recognize the payment value within “research and development” or “cost of sales” within the Consolidated Statements of Operations. The corresponding liability for the payment due to this licensor will be recognized in the Consolidated Balance Sheets within “accounts payable and other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or occurs. (c) Service Agreements for Research and Development Activities We have entered into various contracts with numerous third-party service providers for the execution of our research and development initiatives. These vendors include raw material suppliers, clinical trial sites, clinical research organizations, and data monitoring centers, among others. The financial terms of these agreements are varied and generally obligate us to pay in stages, depending on the achievement of certain events specified in the agreements - such as contract execution, progress of service completion, delivery of drug supply, and the dosing of patients in clinical studies. We recognize these “research and development” expenses and corresponding “accounts payable and other accrued liabilities” in the accompanying financial statements based on estimates of our vendors’ progress of performed services, patient enrollments and dosing, completion of clinical studies, and other events. Should we decide to discontinue and/or slow-down the work on any project, the associated costs for those projects would typically be limited to the extent of the work completed, as we are generally able to terminate these contracts with adequate notice. (d) Supply and Service Agreements Associated with Product Production We have various product supply agreements and/or have issued vendor purchase orders that obligate us to agreed-upon raw material purchases from certain vendors. We also have certain drug production service agreements with select contract manufacturers that obligate us to service fees during the contractual period. These collective commitments do not exceed our planned commercial requirements; the corresponding contracted prices do not exceed their current fair market values. (e) Employment Agreements We entered into revised employment agreements with each of our named executive officers (chief executive officer, chief operating officer, chief financial officer, chief legal officer, and chief medical officer) in April/June 2018 and June 2019, which supersede any prior change in control severance agreements with such individuals. These agreements provide for the payment of certain benefits to each executive upon his separation of employment under specified circumstances. These arrangements are designed to encourage each to act in the best interests of our stockholders at all times during the course of a change in control event or other significant transaction. (f) Deferred Compensation Plan The Spectrum Pharmaceuticals, Inc. Deferred Compensation Plan (the “DC Plan”) is administered by the Compensation Committee of our Board of Directors and is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended. The DC Plan is maintained to provide special deferred benefits for a select group of our employees (the “DC Participants”). DC Participants make annual elections to defer a portion of their eligible cash compensation which is then placed into their DC Plan accounts. We match a fixed percentage of these deferrals, and may make additional discretionary contributions. At September 30, 2021 and December 31, 2020, the aggregate value of this DC Plan liability was $10.5 million and $9.8 million, respectively, and is included within “accounts payable and other accrued liabilities” and “other long-term liabilities” in the accompanying Condensed Consolidated Balance Sheets. (g) Litigation We are involved from time-to-time with various legal matters arising in the ordinary course of business. These claims and legal proceedings are of a nature we believe are normal and incidental to a pharmaceutical business, and may include product liability, intellectual property, employment matters, and other general claims. We may also be subject to derivative lawsuits from time to time. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are assessed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. Although the ultimate resolution of these various matters cannot be determined at this time, we do not believe that such matters, individually or in the aggregate, will have a material adverse effect on our consolidated results of operations, cash flows, or financial condition. Bioverativ Patent Litigation On May 28, 2021, Bioverativ Therapeutics Inc. (“Bioverativ”) filed a complaint against us in the U.S. District Court for the District of Delaware, which alleges that our proposed manufacture, use and sale of ROLONTIS would, if approved, infringe claims of three patents owned by Bioverativ (the “Subject Patents”). Bioverativ is seeking an unspecified amount of damages and injunctive relief. We believe that our manufacture, use and sale of ROLONTIS would not infringe the Subject Patents and intend to vigorously defend our right to develop and commercialize ROLONTIS in accordance with the terms of our agreements with Hanmi. Pursuant to our agreements with Hanmi, we hold worldwide rights (except for Korea, China, and Japan) to develop and commercialize ROLONTIS. The agreements with Hanmi contain typical license terms including, without limitation, indemnification rights in favor of the Company with respect to any claims of infringement from a third party with respect to our use of a licensed technology, product or compound pursuant to such agreements. Shareholder Litigation On August 31, 2021, a shareholder lawsuit was filed against us in the U.S. District Court for the District of Nevada, which alleges that we and certain of our executive officers made false or misleading statements and failed to disclose material facts about our business and the prospects of approval for our BLA to the FDA for ROLONTIS in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934, as amended. On November 1, 2021, four individuals and one entity filed competing motions to be appointed lead plaintiff and for approval of counsel in this putative securities class action. The plaintiffs seek damages, interest, costs, attorneys’ fees, and other unspecified equitable relief. We believe that these claims are without merit, and intend to vigorously defend against these claims. |
Discontinued Operations
Discontinued Operations | 9 Months Ended |
Sep. 30, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | Discontinued Operations Overview In March 2019, we completed the Commercial Product Portfolio Transaction. In accordance with applicable GAAP ( ASC 205-20, Presentation of Financial Statements ), the revenue-deriving activities and allocable expenses of our sold commercial operation, connected to the Commercial Product Portfolio, are separately classified as “discontinued” for all periods presented within the accompanying Condensed Consolidated Statements of Operations. Condensed Consolidated Statements of Operations The following table presents the various elements of “income (loss) from discontinued operations, net of income taxes” as reported in the accompanying Condensed Consolidated Statements of Operations: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Revenues: Product sales, net $ — $ (1) $ — $ (101) Total revenues — (1) — (101) Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) 6 — 133 (229) Selling, general and administrative — — — (1) Research and development 5 (67) 94 (126) Total operating costs and expenses 11 (67) 227 (356) Income (loss) from discontinued operations before income taxes (11) 66 (227) 255 Provision for income taxes from discontinued operations — — — — Income (loss) from discontinued operations, net of income taxes $ (11) $ 66 $ (227) $ 255 Condensed Consolidated Balance Sheets Accounts receivable derived from our product sales on and prior to February 28, 2019 were not transferred to Acrotech as part of Commercial Product Portfolio Transaction, nor were our GTN liabilities and trade accounts payable assumed by Acrotech that were associated with our commercial activities on and prior to February 28, 2019. Accordingly, these specific assets and liabilities remain presented within “accounts receivable, net and “accounts payable and other accrued liabilities” on the accompanying Condensed Consolidated Balance Sheets. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Sale of Common Stock Under ATM Agreement On April 5, 2019, we entered into a collective at-the-market-issuance (“ATM”) sales agreement with Cantor Fitzgerald & Co., H.C. Wainwright & Co., LLC and B. Riley FBR, Inc. (the “April 2019 ATM Agreement”), pursuant to which we may offer and sell shares of our common stock by any method deemed to be an “at the market” offering (the “ATM Offering”). From April 5, 2019 to March 2, 2020, the ATM Offering was conducted pursuant to a sales agreement prospectus filed with our automatic shelf registration statement on Form S-3ASR, filed with the SEC on April 5, 2019, which registered an aggregate offering price of $150 million under the April 2019 ATM Agreement. From May 8, 2020 to June 30, 2020, the ATM Offering was conducted pursuant to a sales agreement prospectus (the “Initial Sales Agreement Prospectus”) filed with our shelf registration statement on Form S-3, filed with the SEC on March 20, 2020, as amended by Pre-Effective Amendment No. 1 thereto, and declared effective by the SEC on May 8, 2020 (the “Registration Statement”), which registered an aggregate offering price of up to $75 million under the April 2019 ATM Agreement. On July 29, 2020, we terminated the Initial Sales Agreement Prospectus, but left the April 2019 ATM Agreement in full force and effect. On November 6, 2020, we filed a new sales agreement prospectus to the Registration Statement, which registered an aggregate offering price of up to $60 million under the April 2019 ATM Agreement. On July 13, 2021, we filed a shelf registration statement with the SEC on Form S-3, which was declared effective by the SEC on July 21, 2021 (the “Registration Statement”). The Registration Statement registered an aggregate offering price of up to $300 million of securities that may be issued and sold by us from time to time, including up to an aggregate offering price of $150 million of common stock (which amount is included in the $300 million aggregate offering price set forth in the base prospectus) that may be issued and sold pursuant to the April 2019 ATM Agreement. We sold and issued common shares under the April 2019 ATM Agreement as follows: Period in Which Issued No. of Common Shares Issued Proceeds Received Year ended December 31, 2019 221,529 $ 1,814 Year ended December 31, 2020 3,950,398 $ 14,902 Quarter ended March 31, 2021 5,678,893 $ 21,357 Quarter ended June 30, 2021 10,172,498 $ 31,265 Quarter ended September 30, 2021 — $ — |
Description of Business, Basi_2
Description of Business, Basis of Presentation, and Operating Segment (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharmaceutical company, with a primary strategy comprised of acquiring, developing, and commercializing novel and targeted oncology therapies. Our in-house development organization includes clinical development, regulatory, quality and data management. We have three drugs in development: • ROLONTIS, a novel long-acting granulocyte colony-stimulating factor (“G-CSF”) for chemotherapy-induced neutropenia. We submitted a Biologics License Application (“BLA”) for ROLONTIS in December 2019, and in August 2021, we received a Complete Response Letter from the U.S. Food and Drug Administration (the “FDA”) regarding our Biologics License Application (“BLA”), citing deficiencies related to manufacturing and indicating that a reinspection will be necessary. We are currently working on remediating the manufacturing deficiencies and expect that this work will be complete in the fourth quarter of 2021 and plan to resubmit thereafter; • Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations. A New Drug Application (“NDA”) based on data from Cohort 2 of ZENITH20, which evaluated previously treated patients with NSCLC with HER2 exon 20 insertion mutation, is expected to be filed with the FDA in 2021; and • Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma patients. |
Basis of Presentation | Basis of Presentation Interim Financial Statements The interim financial data for the three and nine months ended September 30, 2021 and 2020 is unaudited and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the three and nine months ended September 30, 2021 and 2020. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. Certain prior period amounts have been reclassified for consistency with the current year presentation. The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included within our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (filed with the SEC on March 31, 2021). Discontinued Operations - Sale of our Commercial Product Portfolio In March 2019, we completed the sale of our seven then-commercialized drugs, including FUSILEV, KHAPZORY, FOLOTYN, ZEVALIN , MARQIBO, BELEODAQ, and EVOMELA (the “Commercial Product Portfolio”) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). Upon closing, we received $158.8 million in an upfront cash payment. We are also entitled to receive up to an aggregate of $140 million upon Acrotech's future achievement of certain regulatory milestones (totaling $40 million) and sales-based milestones (totaling $100 million) relating to the Commercial Product Portfolio. Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with GAAP and with the rules and regulations of the SEC. These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. Substantially all of the accumulated other comprehensive loss is comprised of foreign currency translation adjustments at September 30, 2021. Liquidity and Capital Resources We believe that our $133.6 million in aggregate cash, cash equivalents and marketable securities as of September 30, 2021, are sufficient to fund our current and planned operations for at least the next twelve months. We may however, require additional liquidity as we continue to execute our business strategy, and in connection with opportunistic acquisitions or licensing arrangements. We anticipate that to the extent that we require additional liquidity, it will be funded through additional equity or debt financings, or out-licensing arrangements. However, we cannot provide assurance that we will be able to obtain this additional liquidity on terms favorable to us or our current stockholders, if at all. Additionally, our liquidity and our ability to fund our capital requirements are also dependent on our future financial performance which is subject to various market and economic factors that are beyond our control. |
Operating Segment | Operating SegmentWe operate one reportable operating segment that is focused exclusively on developing (and eventually marketing) oncology and hematology drug products. For the three and nine months ended September 30, 2021 and 2020, all of our revenues and operating costs and expenses were solely attributable to these activities (and as applicable, classified as “discontinued” within the accompanying Condensed Consolidated Statements of Operations). |
Revenue Recognition | Revenue Recognition In March 2019, we completed the Commercial Product Portfolio Transaction. In accordance with applicable GAAP ( ASC 205-20, Presentation of Financial Statements ), the revenue-deriving activities of our sold commercial operation are separately classified as “discontinued” for all periods presented within the accompanying Condensed Consolidated Statements of Operations. Required Elements of Our Revenue Recognition : Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under Accounting Standards Update (“ ASU ”) No. 2014-09 , Revenue from Contracts with Customers ( “Topic 606” ) in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements: (1) we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable; (2) we identify the “performance obligations” in the respective contract; (3) we determine the “transaction price” for each performance obligation in the respective contract; (4) we allocate the transaction price to each performance obligation; and (5) we recognize revenue only when we satisfy each performance obligation. These five elements, as applied to each of our revenue categories, are summarized below: (a) Product Sales : We sell our products to pharmaceutical wholesalers/distributors or to our product licensees (i.e., our customers). Our wholesalers/distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration. Our gross product sales (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in reported “product sales, net” that reflects the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and group purchasing organization (“GPO”) administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales. These GTN estimate categories (that comprise our GTN liabilities) are each discussed below: Product Returns Allowances : Our customers are contractually permitted to return certain purchased products within the contractual allowable time before/after the applicable expiration date. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns using our historical return rates. Returned product is typically destroyed since substantially all are due to imminent expiry and cannot be resold. Government Chargebacks : Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers. Prompt Pay Discounts : Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage. Commercial Rebates : Commercial rebates are based on (i) our estimates of end-user purchases through a GPO, (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us. Medicaid Rebates : Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in our receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment. Distribution, Data, and GPO Administrative Fees : Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products for various commercial services including: contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales. (b) License Fees : Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (i) upfront license fees, (ii) sales royalties, (iii) sales milestone-achievement fees, and (iv) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows: (1) Upfront License Fees: We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer). (2) Royalties : Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt. (3) Sales Milestones : Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt. (4) Regulatory Milestones : Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee. • When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” (i.e., not recognized) until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. • When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. (c) Service Revenue : We receive fees under certain arrangements for (i) sales and marketing services, (ii) supply chain services, (iii) research and development services, and (iv) clinical trial management services. Our rights to receive payment for these services may be established by (1) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (2) our completion of product delivery in our capacity as a procurement agent, (3) the successful completion of a phase of drug development, (4) favorable results from a clinical trial, and/or (5) regulatory approval events. |
Cash and Cash Equivalents | Cash and Cash EquivalentsCash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. |
Marketable Securities | Marketable SecuritiesMarketable securities consist of our holdings in equity securities (including mutual funds), bank CDs, government-related debt securities, and corporate debt securities. For equity securities and mutual funds, any realized gains (losses) or unrealized gains (losses) are recognized in “other income (expense), net” within the Condensed Consolidated Statements of Operations. Debt securities and bank CDs are classified as “available-for-sale” investments and (1) realized gains (losses) are recognized in “other income (expense), net” within the Condensed Consolidated Statements of Operations and (2) unrealized gains (losses) are recognized as a component of “accumulated other comprehensive loss” within the Condensed Consolidated Statements of Stockholders’ Equity. |
Accounts Receivable, Net | Accounts Receivable, NetOur accounts receivable, net of allowance for credit losses, are derived from our product sales and license fees, and do not bear interest. The allowance for credit losses is management’s best estimate of the amount of expected credit losses in our existing accounts receivable and any anticipated discounts. The allowance for credit losses is adjusted each period through earnings to reflect expected credit losses over the remaining life of the asset. Account balances are written off against the allowance after appropriate collection efforts are exhausted. |
Inventories | Inventories We value our inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its net realizable value, which takes into account our sales forecast by product and corresponding expiry dates of each product lot. Manufacturing costs of drug products that are pending FDA approval during clinical development and trials, and at-risk inventory build in anticipation of commercialization, are exclusively recognized through “research and development” expense on the accompanying Condensed Consolidated Statements of Operations. |
Property and Equipment, Net | Property and Equipment, NetOur property and equipment, net is stated at historical cost, and is depreciated on a straight-line basis over an estimated useful life that corresponds with its designated asset category. We evaluate the recoverability of “long-lived assets” (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable. Recoverability is measured by a comparison of the carrying amount to the net undiscounted cash flows expected to be generated by the asset group. An impairment loss would be recorded for the excess of net carrying value over the fair value of the asset impaired. The fair value is estimated based on expected discounted future cash flows or other methods such as orderly liquidation value based on assumptions of asset class and observed market data. An orderly liquidation value is the amount that could be realized upon liquidation, given a sufficient amount of time to find a purchaser for a sale of assets in their existing condition and location, as of a specific date, and assuming the sale is to market participants who can utilize such assets in their highest and best use. The orderly liquidation values are applied against the carrying values of the assets and the impairment loss is measured as the difference between the liquidation value and the carrying value of the assets. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for equity awards granted to our employees and members of our Board of Directors is recognized on a straight-line basis over each award’s vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited prior to vesting, though is ultimately adjusted for actual forfeitures. We use the Black-Scholes option pricing model to determine the fair value of stock options and stock appreciation rights (as of the date of grant) that have service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) that have combined market conditions and service conditions for vesting. The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term that the stock option will remain outstanding, (c) our stock price volatility over the expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the prevailing risk-free interest rate for the period matching the expected term. With regard to (a)-(d) above: we estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on the historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option. |
Basic and Diluted Net Loss per Share | Basic and Diluted Net Loss per ShareWe calculate basic and diluted net loss per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only stock options, warrants, and other common stock equivalents outstanding during the period to the extent that they are dilutive. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. We apply an estimated annual effective tax rate (“ETR”) approach for calculating a tax provision for interim periods. Our ETR differs from the U.S. federal statutory tax rate primarily as a result of nondeductible expenses and the impact of a valuation allowance on our deferred tax assets, which we record because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income in the period that such determination was made. In the event that we are assessed interest and/or penalties from taxing authorities that have not been previously accrued, such amounts would be included in “benefit for income taxes from continuing operations” within the accompanying Condensed Consolidated Statements of Operations for the period in which we received the notice. In March 2020, we elected to early adopt ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ,” which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. |
Research and Development Expenses | Research and Development ExpensesOur research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, benefits, and other staff-related costs including associated stock-based compensation, laboratory supplies, clinical trial and related clinical manufacturing costs, costs related to manufacturing preparations, fees paid to other entities that conduct certain research and development activities on our behalf and payments made pursuant to license agreements. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. We accrue for costs incurred as the services are being provided by monitoring the status of activities and the invoices received from our external service providers. We adjust our accruals as actual costs become known. Where contingent milestone payments are due to third parties under research and development or license agreements, the milestone payment obligations are expensed when the clinical or regulatory milestone results are achieved. |
Fair Value Measurements | Fair Value Measurements We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Asset and Liability Fair Values | The table below summarizes certain asset and liability fair values that are included within our accompanying Condensed Consolidated Balance Sheets, and their designations among the three fair value measurement categories: September 30, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 92,172 $ — $ — $ 92,172 Equity securities 10,237 — — 10,237 Government-related debt securities 10,023 — — 10,023 Mutual funds 5,900 9 — 5,909 Key employee life insurance, cash surrender value (1) — 4,287 — 4,287 $ 118,332 $ 4,296 $ — $ 122,628 Liabilities: Deferred executive compensation liability (2) $ — $ 10,489 $ — $ 10,489 $ — $ 10,489 $ — $ 10,489 (1) Included within other assets on our Condensed Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $1.1 million within accounts payable and other accrued liabilities and $9.4 million within other long-term liabilities on our Condensed Consolidated Balance Sheets. The amounts are based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. December 31, 2020 Level 1 Level 2 Level 3 Total Assets: Government-related debt securities $ 92,928 $ — $ — $ 92,928 Corporate debt securities — 8,848 — 8,848 Money market funds 40,560 — — 40,560 Equity securities 24,946 — — 24,946 Bank CDs — 1,721 — 1,721 Mutual funds 5,573 9 — 5,582 Key employee life insurance, cash surrender value (1) — 3,963 — 3,963 $ 164,007 $ 14,541 $ — $ 178,548 Liabilities: Deferred executive compensation liability (2) $ — $ 9,783 $ — $ 9,783 $ — $ 9,783 $ — $ 9,783 (1) Included within other assets on our Condensed Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $1.3 million within accounts payable and other accrued liabilities and $8.5 million within other long-term liabilities on our Condensed Consolidated Balance Sheets. The amounts are based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. |
Balance Sheet Account Detail (T
Balance Sheet Account Detail (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Cash and Cash Equivalents and Marketable Securities | The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Fair Cash and Cash Marketable September 30, 2021 Money market funds $ 92,172 $ 92,172 $ 92,172 $ — Equity securities (1) 3,528 10,237 — 10,237 Government-related debt securities 10,023 10,023 — 10,023 Mutual funds 4,753 5,900 — 5,900 Bank deposits 15,263 15,263 15,263 — Total cash and cash equivalents and marketable securities $ 125,739 $ 133,595 $ 107,435 $ 26,160 December 31, 2020 Money market funds $ 40,560 $ 40,560 $ 40,560 $ — Equity securities 3,764 24,946 — 24,946 Government-related debt securities 92,881 92,928 — 92,928 Corporate debt securities 8,846 8,848 — 8,848 Mutual funds 4,497 5,573 — 5,573 Bank CDs 1,715 1,721 — 1,721 Bank deposits 5,449 5,449 5,449 — Total cash and cash equivalents and marketable securities $ 157,712 $ 180,025 $ 46,009 $ 134,016 |
Schedule of Other Receivables | “Other receivables” consists of the following: September 30, 2021 December 31, 2020 Other miscellaneous receivables $ 2,443 $ 901 Income tax receivable - current portion 1,297 1,297 Interest receivable from marketable securities 123 196 Other receivables $ 3,863 $ 2,394 |
Schedule of Prepaid Expenses and Other Current Assets | “Prepaid expenses and other current assets” consists of the following: September 30, 2021 December 31, 2020 Prepaid expenses and deferred costs $ 2,370 $ 1,996 Prepaid insurance 170 2,165 Prepaid expenses and other current assets $ 2,540 $ 4,161 |
Schedule of Property and Equipment, net | “Property and equipment, net” consists of the following: September 30, 2021 December 31, 2020 Manufacturing equipment $ — $ 3,245 Computer hardware and software 1,802 1,680 Laboratory equipment 5 5 Leasehold improvements 1,267 1,267 Office furniture 307 248 Property and equipment, at cost 3,381 6,445 (Less): Accumulated depreciation (2,874) (2,868) Property and equipment, net $ 507 $ 3,577 |
Schedule of Accounts Payable and Other Accrued Liabilities | “Accounts payable and other accrued liabilities” consists of the following : September 30, 2021 December 31, 2020 Trade accounts payable and other $ 40,914 $ 34,385 Lease liability - current portion 1,451 1,544 Commercial Product Portfolio accruals (Note 7) 6,617 7,842 Accounts payable and other accrued liabilities $ 48,982 $ 43,771 |
Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities | Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed Consolidated Balance Sheets for our categories of GTN estimates related to the Commercial Product Portfolio accruals were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, Data, Inventory and Product Return Allowances Total Balance as of December 31, 2019 $ 14,671 $ 1,138 $ 4,714 $ 20,523 (Less): Payments and credits against GTN accruals (12,070) (196) (415) (12,681) Balance as of December 31, 2020 $ 2,601 $ 942 $ 4,299 $ 7,842 (Less): Payments and credits against GTN accruals (1,160) — (65) (1,225) Balance as of September 30, 2021 $ 1,441 $ 942 $ 4,234 $ 6,617 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock-Based Compensation Expense | We report our stock-based compensation expense (inclusive of our incentive stock plan and employee stock purchase plan) in the accompanying Condensed Consolidated Statements of Operations within “total operating costs and expenses” for the three and nine months ended September 30, 2021 and 2020, as follows: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Selling, general and administrative $ 2,927 $ 3,018 $ 8,730 $ 9,773 Research and development 1,187 1,090 3,956 3,598 Total stock-based compensation $ 4,114 $ 4,108 $ 12,686 $ 13,371 |
Financial Commitments and Con_2
Financial Commitments and Contingencies and Key License Agreements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Lease Assets and Liabilities | The below table summarizes the lease asset and liability accounts presented on our accompanying Condensed Consolidated Balance Sheets: Operating Leases Condensed Consolidated Balance Sheet Caption September 30, 2021 December 31, 2020 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 2,881 $ 2,247 Operating lease liabilities - current Accounts payable and other accrued liabilities 1,451 1,544 Operating lease liabilities - non-current Other long-term liabilities 1,593 883 Total operating lease liabilities $ 3,044 $ 2,427 |
Components of Aggregate Lease Expense | The components of our aggregate lease expense is summarized below: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Operating lease cost $ 381 $ 466 $ 1,274 $ 1,398 Variable lease cost 79 86 280 314 Short-term lease cost 13 17 46 46 Total lease cost $ 473 $ 569 $ 1,600 $ 1,758 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of September 30, 2021 2.7 years 4.2% Operating leases as of December 31, 2020 1.6 years 7.8% |
Future Contractual Lease Payments | The below table summarizes our (i) minimum lease payments over the next five years, (ii) lease arrangement implied interest, and (iii) present value of future lease payments: Operating Leases - future payments September 30, 2021 2021 (remaining) $ 382 2022 1,301 2023 657 2024 669 2025 98 2026 73 Total future lease payments, undiscounted $ 3,180 (Less): Implied interest (136) Present value of operating lease payments $ 3,044 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Condensed Consolidated Statements of Operations and Cash Flows | The following table presents the various elements of “income (loss) from discontinued operations, net of income taxes” as reported in the accompanying Condensed Consolidated Statements of Operations: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Revenues: Product sales, net $ — $ (1) $ — $ (101) Total revenues — (1) — (101) Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) 6 — 133 (229) Selling, general and administrative — — — (1) Research and development 5 (67) 94 (126) Total operating costs and expenses 11 (67) 227 (356) Income (loss) from discontinued operations before income taxes (11) 66 (227) 255 Provision for income taxes from discontinued operations — — — — Income (loss) from discontinued operations, net of income taxes $ (11) $ 66 $ (227) $ 255 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Schedule of Stock by Class | We sold and issued common shares under the April 2019 ATM Agreement as follows: Period in Which Issued No. of Common Shares Issued Proceeds Received Year ended December 31, 2019 221,529 $ 1,814 Year ended December 31, 2020 3,950,398 $ 14,902 Quarter ended March 31, 2021 5,678,893 $ 21,357 Quarter ended June 30, 2021 10,172,498 $ 31,265 Quarter ended September 30, 2021 — $ — |
Description of Business, Basi_3
Description of Business, Basis of Presentation, and Operating Segment (Details) $ in Millions | 1 Months Ended | 9 Months Ended |
Mar. 31, 2019USD ($)product | Sep. 30, 2021USD ($)productsegment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of drugs in development | product | 3 | |
Segment Reporting Information [Line Items] | ||
Aggregate cash, cash equivalents and marketable securities | $ 133.6 | |
Number of reportable operating segment | segment | 1 | |
Sale | Commercial Product Portfolio | ||
Segment Reporting Information [Line Items] | ||
Number of products | product | 7 | |
Consideration | $ 158.8 | |
Aggregate amount receivable based on achievement of milestones | 140 | |
Payments receivable based on achievement of regulatory milestones | 40 | |
Potential payments based on achievement of sales milestones | $ 100 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Use of Estimates - Schedule of Outstanding Securities Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Accounting Policies [Abstract] | ||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 12,708,185 | 9,648,862 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Asset and Liability Fair Values (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Assets: | ||
Equity securities | $ 10,237 | $ 24,946 |
Key employee life insurance, cash surrender value | 4,287 | 3,963 |
Total Assets | 122,628 | 178,548 |
Liabilities: | ||
Deferred executive compensation liability | 10,489 | 9,783 |
Total Liabilities | 10,489 | 9,783 |
Money market funds | ||
Assets: | ||
Available-for-sale | 92,172 | 40,560 |
Government-related debt securities | ||
Assets: | ||
Available-for-sale | 10,023 | 92,928 |
Corporate debt securities | ||
Assets: | ||
Available-for-sale | 8,848 | |
Bank CDs | ||
Assets: | ||
Available-for-sale | 1,721 | |
Mutual funds | ||
Assets: | ||
Available-for-sale | 5,909 | 5,582 |
Level 1 | ||
Assets: | ||
Equity securities | 10,237 | 24,946 |
Key employee life insurance, cash surrender value | 0 | 0 |
Total Assets | 118,332 | 164,007 |
Liabilities: | ||
Deferred executive compensation liability | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 1 | Money market funds | ||
Assets: | ||
Available-for-sale | 92,172 | 40,560 |
Level 1 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 10,023 | 92,928 |
Level 1 | Corporate debt securities | ||
Assets: | ||
Available-for-sale | 0 | |
Level 1 | Bank CDs | ||
Assets: | ||
Available-for-sale | 0 | |
Level 1 | Mutual funds | ||
Assets: | ||
Available-for-sale | 5,900 | 5,573 |
Level 2 | ||
Assets: | ||
Equity securities | 0 | 0 |
Key employee life insurance, cash surrender value | 4,287 | 3,963 |
Total Assets | 4,296 | 14,541 |
Liabilities: | ||
Deferred executive compensation liability | 10,489 | 9,783 |
Total Liabilities | 10,489 | 9,783 |
Deferred executive compensation in accounts payable and other accrued liabilities | 1,100 | 1,300 |
Deferred executive compensation in other long-term liabilities | 9,400 | 8,500 |
Level 2 | Money market funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 2 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 2 | Corporate debt securities | ||
Assets: | ||
Available-for-sale | 8,848 | |
Level 2 | Bank CDs | ||
Assets: | ||
Available-for-sale | 1,721 | |
Level 2 | Mutual funds | ||
Assets: | ||
Available-for-sale | 9 | 9 |
Level 3 | ||
Assets: | ||
Equity securities | 0 | 0 |
Key employee life insurance, cash surrender value | 0 | 0 |
Total Assets | 0 | 0 |
Liabilities: | ||
Deferred executive compensation liability | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 3 | Money market funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 | Corporate debt securities | ||
Assets: | ||
Available-for-sale | 0 | |
Level 3 | Bank CDs | ||
Assets: | ||
Available-for-sale | 0 | |
Level 3 | Mutual funds | ||
Assets: | ||
Available-for-sale | $ 0 | $ 0 |
Balance Sheet Account Detail -
Balance Sheet Account Detail - Summary of Cash and Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands, shares in Millions | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | $ 3,528 | $ 3,764 | |
Equity securities | 10,237 | 24,946 | |
Historical or Amortized Cost | 125,739 | 157,712 | |
Cash, cash equivalents, and short-term investments | 133,595 | 180,025 | |
Realized gain on sale of equity holdings | 4,580 | $ 678 | |
CASI Common Stock | |||
Schedule of Investments [Line Items] | |||
Equity securities | $ 7,900 | ||
Number of shares held in investment (in shares) | 6.7 | ||
Number of common shares sale in investments (shares) | 1.8 | ||
Realized gain on sale of equity holdings | $ 4,200 | ||
Unicycive Therapeutics, Inc. | |||
Schedule of Investments [Line Items] | |||
Equity securities | $ 2,300 | ||
Number of shares held in investment (in shares) | 0.8 | ||
Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Equity securities | $ 0 | 0 | |
Cash, cash equivalents, and short-term investments | 107,435 | 46,009 | |
Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Equity securities | 10,237 | 24,946 | |
Cash, cash equivalents, and short-term investments | 26,160 | 134,016 | |
Money market funds | |||
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | 92,172 | 40,560 | |
Available-for-sale | 92,172 | 40,560 | |
Money market funds | Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 92,172 | 40,560 | |
Money market funds | Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 0 | 0 | |
Government-related debt securities | |||
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | 10,023 | 92,881 | |
Available-for-sale | 10,023 | 92,928 | |
Government-related debt securities | Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 0 | 0 | |
Government-related debt securities | Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 10,023 | 92,928 | |
Corporate debt securities | |||
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | 8,846 | ||
Available-for-sale | 8,848 | ||
Corporate debt securities | Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 0 | ||
Corporate debt securities | Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 8,848 | ||
Mutual funds | |||
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | 4,753 | 4,497 | |
Available-for-sale | 5,900 | 5,573 | |
Mutual funds | Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 0 | 0 | |
Mutual funds | Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 5,900 | 5,573 | |
Bank CDs | |||
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | 1,715 | ||
Available-for-sale | 1,721 | ||
Bank CDs | Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 0 | ||
Bank CDs | Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 1,721 | ||
Bank deposits | |||
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | 15,263 | 5,449 | |
Available-for-sale | 15,263 | 5,449 | |
Bank deposits | Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 15,263 | 5,449 | |
Bank deposits | Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | $ 0 | $ 0 |
Balance Sheet Account Detail _2
Balance Sheet Account Detail - Schedule of Other Receivables (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Other miscellaneous receivables | $ 2,443 | $ 901 |
Income tax receivable - current portion | 1,297 | 1,297 |
Interest receivable from marketable securities | 123 | 196 |
Other receivables | $ 3,863 | $ 2,394 |
Balance Sheet Account Detail _3
Balance Sheet Account Detail - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Prepaid expenses and deferred costs | $ 2,370 | $ 1,996 |
Prepaid insurance | 170 | 2,165 |
Prepaid expenses and other current assets | $ 2,540 | $ 4,161 |
Balance Sheet Account Detail _4
Balance Sheet Account Detail - Schedule of Property and Equipment Net of Accumulated Depreciation (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 3,381 | $ 6,445 |
(Less): Accumulated depreciation | (2,874) | (2,868) |
Property and equipment, net | 507 | 3,577 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 0 | 3,245 |
Computer hardware and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 1,802 | 1,680 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 5 | 5 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 1,267 | 1,267 |
Office furniture | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 307 | $ 248 |
Balance Sheet Account Detail _5
Balance Sheet Account Detail - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Impairment of second source manufacturer | $ 19,700 | |||
Incremental research and development expense | $ 2,900 | $ 3,057 | $ 0 |
Balance Sheet Account Detail _6
Balance Sheet Account Detail - Schedule of Accounts Payable and Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other | $ 40,914 | $ 34,385 |
Lease liability - current portion | 1,451 | 1,544 |
Commercial Product Portfolio accruals (Note 7) | 6,617 | 7,842 |
Accounts payable and other accrued liabilities | $ 48,982 | $ 43,771 |
Balance Sheet Account Detail _7
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | $ 7,842 | $ 20,523 |
(Less): Payments and credits against GTN accruals | (1,225) | (12,681) |
Ending balance | 6,617 | 7,842 |
Commercial/Medicaid Rebates and Government Chargebacks | ||
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | 2,601 | 14,671 |
(Less): Payments and credits against GTN accruals | (1,160) | (12,070) |
Ending balance | 1,441 | 2,601 |
Distribution, Data, Inventory and GPO Administrative Fees | ||
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | 942 | 1,138 |
(Less): Payments and credits against GTN accruals | 0 | (196) |
Ending balance | 942 | 942 |
Product Return Allowances | ||
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | 4,299 | 4,714 |
(Less): Payments and credits against GTN accruals | (65) | (415) |
Ending balance | $ 4,234 | $ 4,299 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 4,114 | $ 4,108 | $ 12,686 | $ 13,371 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | 2,927 | 3,018 | 8,730 | 9,773 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 1,187 | $ 1,090 | $ 3,956 | $ 3,598 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) shares in Millions | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock options granted (shares) | shares | 3.5 |
Stock options weighted average exercise price ($ per share) | $ / shares | $ 3.65 |
Stock options outstanding (shares) | shares | 12.4 |
Stock options outstanding weighted average exercise price ($ per share) | $ / shares | $ 5.87 |
Restricted Stock | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Awards granted (shares) | shares | 2.4 |
Awards weighted average grant date fair value($ per share) | $ / shares | $ 3.62 |
Awards outstanding (shares) | shares | 4.9 |
Awards outstanding weighted average grant date fair value ($ per share) | $ / shares | $ 4.70 |
Financial Commitments and Con_3
Financial Commitments and Contingencies and Key License Agreements - Additional Information (Details) $ in Thousands | Aug. 31, 2021plaintiff | May 28, 2021patent | Dec. 31, 2020USD ($) | Apr. 30, 2019USD ($)product | Apr. 30, 2018USD ($) | Feb. 28, 2015USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2021USD ($) |
Long-term Purchase Commitment [Line Items] | ||||||||
Right-of-use assets in exchange for lease liabilities | $ 1,800 | $ 1,800 | ||||||
Lease liabilities in exchange for right-of-use assets | 1,800 | 1,800 | ||||||
Facility and equipment under lease | $ 2,247 | 2,881 | 2,881 | |||||
Licensors | product | 2 | |||||||
Deferred executive compensation liability | 9,783 | 10,489 | 10,489 | |||||
Bioverativ Therapeutics Inc., Subject Patents | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Patents allegedly infringed | patent | 3 | |||||||
ImmunGene | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Potential payments based on achievement of regulatory milestones | $ 26,100 | |||||||
Asset purchase agreement, upfront payment | 2,800 | |||||||
Potential payments based on additional achievements of regulatory milestones | $ 5,000 | |||||||
Therapyx | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Asset purchase agreement, upfront payment | 800 | |||||||
Potential payments based on additional achievements of regulatory milestones | 2,200 | |||||||
Potential payments based on worldwide annual net sales | 167,500 | |||||||
Therapyx | I L12 Product | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Potential payments based on additional achievements of regulatory milestones | 30,000 | |||||||
Therapyx | Each new indication approved | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Potential payments based on additional achievements of regulatory milestones | 2,500 | |||||||
Individual | Shareholder Litigation | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Number of plaintiffs | plaintiff | 4 | |||||||
Entity | Shareholder Litigation | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Number of plaintiffs | plaintiff | 1 | |||||||
MD Anderson | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Potential payments based on achievement of regulatory milestones | $ 6,000 | |||||||
Potential payments based on achievement of sales milestones | 24,000 | |||||||
Upfront payment | $ 500 | |||||||
SPI-2012 | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Potential payments based on achievement of regulatory milestones | 10,000 | |||||||
Potential payments based on achievement of sales milestones | 120,000 | |||||||
Poziotinib | In-license agreement | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Potential payments based on achievement of regulatory milestones | $ 33,000 | |||||||
Potential payments based on achievement of sales milestones | $ 325,000 | |||||||
Office and research facilities | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Facility and equipment under lease | 1,900 | 2,500 | 2,500 | |||||
Office equipment | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Facility and equipment under lease | $ 300 | $ 400 | $ 400 | |||||
Minimum | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Remaining lease term | 1 year | 1 year | ||||||
Maximum | ||||||||
Long-term Purchase Commitment [Line Items] | ||||||||
Remaining lease term | 5 years | 5 years |
Financial Commitments and Con_4
Financial Commitments and Contingencies and Key License Agreements - Operating Lease Balance Sheet Information (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use assets - non-current | $ 2,881 | $ 2,247 |
Operating lease liabilities - current | 1,451 | 1,544 |
Operating lease liabilities - non-current | 1,593 | 883 |
Total operating lease liabilities | $ 3,044 | $ 2,427 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accounts payable and other accrued liabilities | Accounts payable and other accrued liabilities |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other long-term liabilities | Other long-term liabilities |
Financial Commitments and Con_5
Financial Commitments and Contingencies and Key License Agreements - Components of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease cost | $ 381 | $ 466 | $ 1,274 | $ 1,398 |
Variable lease cost | 79 | 86 | 280 | 314 |
Short-term lease cost | 13 | 17 | 46 | 46 |
Total lease cost | $ 473 | $ 569 | $ 1,600 | $ 1,758 |
Financial Commitments and Con_6
Financial Commitments and Contingencies and Key License Agreements - Summary of Operating Lease Term and Discount Rate (Details) | Sep. 30, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted Average Remaining Lease Term | 2 years 8 months 12 days | 1 year 7 months 6 days |
Weighted Average Discount Rate | 4.20% | 7.80% |
Financial Commitments and Con_7
Financial Commitments and Contingencies and Key License Agreements - Contractual Lease Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
2021 (remaining) | $ 382 | |
2022 | 1,301 | |
2023 | 657 | |
2024 | 669 | |
2025 | 98 | |
2026 | 73 | |
Total future lease payments, undiscounted | 3,180 | |
(Less): Implied interest | (136) | |
Present value of operating lease payments | $ 3,044 | $ 2,427 |
Discontinued Operations - Conde
Discontinued Operations - Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating costs and expenses: | ||||
Income (loss) from discontinued operations, net of income taxes | $ (11) | $ 66 | $ (227) | $ 255 |
Sale | Commercial Product Portfolio | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | 0 | (1) | 0 | (101) |
Operating costs and expenses: | ||||
Cost of sales (excluding amortization of intangible assets) | 6 | 0 | 133 | (229) |
Selling, general and administrative | 0 | 0 | 0 | (1) |
Research and development | 5 | (67) | 94 | (126) |
Total operating costs and expenses | 11 | (67) | 227 | (356) |
Income (loss) from discontinued operations before income taxes | (11) | 66 | (227) | 255 |
Provision for income taxes from discontinued operations | 0 | 0 | 0 | 0 |
Income (loss) from discontinued operations, net of income taxes | (11) | 66 | (227) | 255 |
Sale | Commercial Product Portfolio | Product sales, net | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | $ 0 | $ (1) | $ 0 | $ (101) |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | Jul. 21, 2021 | Nov. 06, 2020 | May 08, 2020 | Apr. 05, 2019 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Subsidiary, Sale of Stock [Line Items] | |||||||||
Common stock issued (in shares) | 0 | 10,172,498 | 5,678,893 | 3,950,398 | 221,529 | ||||
Proceeds Received (Net of Broker Commissions and Fees ) | $ 0 | $ 31,265,000 | $ 21,357,000 | $ 14,902,000 | $ 1,814,000 | ||||
April 2019 ATM Agreement | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Maximum proceeds | $ 60,000,000 | $ 75,000,000 | $ 150,000,000 | ||||||
Registration Statement | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Maximum proceeds | $ 300,000,000 | ||||||||
Registration Statement | Common Stock | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Maximum proceeds | $ 150,000,000 |