Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 10, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 353.9 | ||
Entity Common Stock, Shares Outstanding | 177,151,513 | ||
Documents Incorporated by Reference | Certain information required by Parts II and III are omitted from this Annual Report on Form 10 K and incorporated by reference to our definitive proxy statement for our 2022 annual meeting of shareholders (“2022 Proxy Statement”), to be filed pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, or the Exchange Act. If our 2022 Proxy Statement is not filed within 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, the omitted information will be included in an amendment to this Annual Report on Form 10-K filed not later than the end of such 120-day period. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0000831547 |
Audit Information
Audit Information | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Auditor Information [Abstract] | ||
Auditor Name | RSM US LLP | Deloitte & Touche LLP |
Auditor Location | Los Angeles, California | Costa Mesa, California |
Auditor Firm ID | 49 | 34 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 88,539 | $ 46,009 |
Marketable securities | 12,108 | 134,016 |
Accounts receivable, net | 0 | 67 |
Other receivables | 1,028 | 2,394 |
Prepaid expenses and other current assets | 2,277 | 4,161 |
Total current assets | 103,952 | 186,647 |
Property and equipment, net | 455 | 3,577 |
Facility and equipment under lease | 2,505 | 2,247 |
Other assets | 4,636 | 4,327 |
Total assets | 111,548 | 196,798 |
Current liabilities: | ||
Accounts payable and other accrued liabilities | 41,258 | 43,771 |
Accrued payroll and benefits | 11,971 | 9,375 |
Total current liabilities | 53,229 | 53,146 |
Other long-term liabilities | 10,766 | 9,409 |
Total liabilities | 63,995 | 62,555 |
Commitments and contingencies (Note 7) | ||
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; 164,502,013 and 146,083,110 issued and outstanding at December 31, 2021 and 2020, respectively | 165 | 146 |
Additional paid-in capital | 1,094,353 | 1,021,221 |
Accumulated other comprehensive loss | (3,042) | (1,829) |
Accumulated deficit | (1,043,923) | (885,295) |
Total stockholders’ equity | 47,553 | 134,243 |
Total liabilities and stockholders’ equity | $ 111,548 | $ 196,798 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 164,502,013 | 146,083,110 |
Common stock, shares outstanding (in shares) | 164,502,013 | 146,083,110 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating costs and expenses: | ||
Selling, general and administrative | $ 60,406 | $ 60,357 |
Research and development | 87,297 | 109,377 |
Total operating costs and expenses | 147,703 | 169,734 |
Loss from continuing operations before other income (expense) and income taxes | (147,703) | (169,734) |
Other income (expense): | ||
Interest income, net | 163 | 1,342 |
Other expense, net | (10,892) | (2,940) |
Total other expense | (10,729) | (1,598) |
Loss from continuing operations before income taxes | (158,432) | (171,332) |
(Provision) benefit for income taxes from continuing operations | (4) | 60 |
Loss from continuing operations | (158,436) | (171,272) |
Income (loss) from discontinued operations, net of income taxes | (192) | 10,404 |
Net loss | $ (158,628) | $ (160,868) |
Basic and diluted loss per share: | ||
Loss per common share from continuing operations, basic (in dollars per share) | $ (1.02) | $ (1.38) |
Loss per common share from continuing operations, diluted (in dollars per share) | (1.02) | (1.38) |
Income per common share from discontinued operations, basic (in dollars per share) | 0 | 0.08 |
Income per common share from discontinued operations, diluted (in dollars per share) | 0 | 0.08 |
Net loss per common share, basic (in dollar per share) | (1.02) | (1.29) |
Net loss per common share, diluted (in dollar per share) | $ (1.02) | $ (1.29) |
Weighted average shares outstanding, basic (in shares) | 154,861,704 | 124,386,545 |
Weighted average shares outstanding, diluted (in shares) | 154,861,704 | 124,386,545 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (158,628) | $ (160,868) |
Other comprehensive (loss) income: | ||
Unrealized (loss) gain on available-for-sale securities, net of tax | (1,147) | 303 |
Foreign currency translation adjustments | (66) | 1,366 |
Other comprehensive (loss) income | (1,213) | 1,669 |
Total comprehensive loss | $ (159,841) | $ (159,199) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Public Offering | Common Stock | Common StockPublic Offering | Common StockAt-the-market Sales Agreement | Additional Paid-In Capital | Additional Paid-In CapitalPublic Offering | Additional Paid-In CapitalAt-the-market Sales Agreement | 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 | (160,868) | (160,868) | ||||||||
Other comprehensive (loss) income | 1,669 | 1,669 | ||||||||
Recognition of stock-based compensation expense | $ 17,554 | 17,554 | ||||||||
Issuance of common shares under an at-the-market sales agreement (in shares) | 3,950,398 | 24,916,667 | 3,950,398 | |||||||
Issuance of common shares under an at-the-market sales agreement | $ 14,902 | $ 69,665 | $ 25 | $ 4 | $ 69,640 | $ 14,898 | ||||
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 | ||||||||
Issuance of common stock for employee stock purchase plan (in shares) | 225,310 | |||||||||
Issuance of common stock for employee stock purchase plan | $ 650 | 650 | ||||||||
Issuance of common stock upon exercise of stock options (in shares) | 3,542 | 3,542 | ||||||||
Issuance of common stock upon exercise of stock options | $ 13 | 13 | ||||||||
Restricted stock award grants, net of forfeitures (in shares) | 3,589,761 | |||||||||
Restricted stock award grants, net of forfeitures | $ 0 | $ 4 | (4) | |||||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 861 | |||||||||
Ending Balance, (in shares) at Dec. 31, 2020 | 146,083,110 | 146,083,110 | ||||||||
Ending Balance at Dec. 31, 2020 | $ 134,243 | $ 146 | 1,021,221 | (1,829) | (885,295) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Net loss | (158,628) | (158,628) | ||||||||
Other comprehensive (loss) income | (1,213) | (1,213) | ||||||||
Recognition of stock-based compensation expense | $ 19,839 | 19,839 | ||||||||
Issuance of common shares under an at-the-market sales agreement (in shares) | 15,851,391 | 15,851,391 | ||||||||
Issuance of common shares under an at-the-market sales agreement | $ 52,621 | $ 16 | $ 52,605 | |||||||
Issuance of common stock for employee stock purchase plan (in shares) | 358,007 | |||||||||
Issuance of common stock for employee stock purchase plan | $ 685 | $ 1 | 684 | |||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,250 | 1,250 | ||||||||
Issuance of common stock upon exercise of stock options | $ 4 | 4 | ||||||||
Restricted stock award grants, net of forfeitures (in shares) | 2,206,869 | |||||||||
Restricted stock award grants, net of forfeitures | $ 2 | $ 2 | ||||||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 1,386 | |||||||||
Ending Balance, (in shares) at Dec. 31, 2021 | 164,502,013 | 164,502,013 | ||||||||
Ending Balance at Dec. 31, 2021 | $ 47,553 | $ 165 | $ 1,094,353 | $ (3,042) | $ (1,043,923) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash Flows From Operating Activities: | ||
Loss from continuing operations | $ (158,436) | $ (171,272) |
(Loss) income from discontinued operations, net of income taxes | (192) | 10,404 |
Net loss | (158,628) | (160,868) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 286 | 261 |
Stock-based compensation | 19,841 | 17,819 |
Impairment of second source manufacturer | 0 | 28,197 |
Loss on disposal of manufacturing equipment | 3,057 | 0 |
Non-cash lease expense | 1,624 | 1,540 |
Accretion (amortization) of premium (discount) on debt securities | 393 | 220 |
Realized gain on mutual funds | (630) | (232) |
Realized gain on sale of equity holdings | (5,722) | (1,408) |
Unrealized loss on equity holdings | 17,266 | 4,487 |
Unrealized loss (gain) from transactions denominated in foreign currency | 460 | 495 |
Bad debt expense (recovery) | (80) | 389 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 66 | 0 |
Other receivables | 1,444 | 7,165 |
Prepaid expenses and other current assets | 1,884 | 1,159 |
Other assets | (310) | (317) |
Accounts payable and other accrued liabilities | (3,513) | (22,053) |
Accrued payroll and benefits | 2,596 | 1,689 |
Other long-term liabilities | 480 | (172) |
Net cash used in operating activities | (119,486) | (121,629) |
Cash Flows From Investing Activities: | ||
Proceeds from maturities of investments | 119,814 | 109,035 |
Proceeds from sale of equity holdings | 5,974 | 3,954 |
Purchases of investments | (16,856) | (89,382) |
Purchases of property and equipment, net | (221) | (5,535) |
Net cash provided by investing activities | 108,711 | 18,072 |
Cash Flows From Financing Activities: | ||
Proceeds from employees for exercises of stock options | 4 | 13 |
Proceeds from sale of stock under our employee stock purchase plan | 685 | 650 |
Net cash provided by financing activities | 53,310 | 85,230 |
Effect of exchange rates on cash and cash equivalents | (5) | (82) |
Net increase (decrease) in cash and cash equivalents | 42,530 | (18,409) |
Cash and cash equivalents — beginning of year | 46,009 | 64,418 |
Cash and cash equivalents — end of year | 88,539 | 46,009 |
Supplemental Disclosure of Cash Flow Information: | ||
Cash paid for facility and equipment under operating leases | 2,116 | 2,401 |
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 | 10,066 |
Public Offering | ||
Cash Flows From Financing Activities: | ||
Proceeds from issuance of common stock | 0 | 69,665 |
At-the-market Sales Agreement | ||
Cash Flows From Financing Activities: | ||
Proceeds from issuance of common stock | $ 52,621 | $ 14,902 |
Description of Business, Basis
Description of Business, Basis of Presentation, and Operating Segment | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [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 two drugs in late-stage development: • Eflapegrastim, a novel long-acting granulocyte colony-stimulating factor (“G-CSF”) for the treatment of chemotherapy-induced neutropenia. On August 6, 2021, the Company announced the receipt of a complete response letter (“CRL”), that cited manufacturing deficiencies related both to the drug substance and drug product manufacturers. The Company believes it has completed the remediation of these deficiencies and resubmitted the Biologics License Application (“BLA”) on March 11, 2022; • Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations. On December 6, 2021, the Company announced it submitted its New Drug Application (“NDA”) for poziotinib to the FDA for use in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations. The NDA submission is based on the positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib. The product has received Fast Track designation and there is currently no treatment specifically approved by the FDA for this indication. On February 11, 2022, the Company announced that it had received notice that the NDA had been accepted and received a PDUFA action date of November 24, 2022. (b) Basis of Presentation Principles of Consolidation The accompanying Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and with the rules and regulations of the Securities and Exchange Commission (“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 December 31, 2021. Discontinued Operations - Sale of our Commercial Product Portfolio In March 2019, we completed the Commercial Product Portfolio Transaction (See Note 9 ). 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 Consolidated Statements of Operations. Liquidity and Capital Resources We believe that our $100.6 million in aggregate cash, cash equivalents, and marketable securities as of December 31, 2021 combined with $20 million of equity financing received from Hanmi in January 2022 is 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 We operate one reportable operating segment that is focused exclusively on developing (and eventually marketing) oncology and hematology drug products. For the years ended December 31, 2021 and 2020, all of our operating costs and |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 12 Months Ended |
Dec. 31, 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 Consolidated Financial Statements are further described below: (i) 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. (ii) 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 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 Consolidated Statements of Operations and (2) unrealized gains (losses) are recognized as a component of “accumulated other comprehensive loss” within the Consolidated Statements of Stockholders’ Equity. (iii) 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 impairments that occurred during the year ended December 31, 2020. There were no impairments recorded during the year ended December 31, 2021. (iv) 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. (v) 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 13.5 million shares and 9.6 million shares of outstanding securities (including stock options, restricted stock units, stock appreciation rights, and performance awards) as of December 31, 2021 and 2020, respectively, that were excluded from the calculation of diluted net loss per share because their inclusion would have been anti-dilutive. (vi) 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 Consolidated Statements of Operations for the period in which we received the notice. (vii) 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. (viii) 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. Level 3: Unobservable inputs are used when little or no market data is available. (ix) Recently Issued Accounting Standards There are several new accounting pronouncements issued by the FASB, which we don’t believe had or will have a material impact on our consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 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 Consolidated Balance Sheets, and their designations among the three fair value measurement categories: December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 66,322 $ — $ — $ 66,322 Equity securities 5,718 — — 5,718 Mutual funds 6,390 9 — 6,399 Key employee life insurance, cash surrender value (1) — 4,507 — 4,507 $ 78,430 $ 4,516 $ — $ 82,946 Liabilities: Deferred executive compensation liability (2) $ — $ 11,243 $ — $ 11,243 $ — $ 11,243 $ — $ 11,243 (1) Included within other assets on our 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 $2.0 million within accounts payable and other accrued liabilities and $9.2 million within other long-term liabilities on our Consolidated Balance Sheets. December 31, 2020 Level 1 Level 2 Level 3 Total Assets: Equity securities $ 24,946 $ — $ — $ 24,946 Money market funds 40,560 — — 40,560 Government-related debt securities 92,928 — — 92,928 Corporate debt securities — 8,848 — 8,848 Mutual funds 5,573 9 — 5,582 Bank CDs — 1,721 — 1,721 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 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 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 | 12 Months Ended |
Dec. 31, 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 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. 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. There were no material unrealized losses on our investment securities at December 31, 2021 or 2020. The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Fair Value Cash and Cash Marketable Securities December 31, 2021 Money market funds $ 66,322 $ 66,322 $ 66,322 $ — Equity securities (1) 3,512 5,718 — 5,718 Mutual funds 5,218 6,390 — 6,390 Bank deposits 22,217 22,217 22,217 — Total cash and cash equivalents and marketable securities $ 97,269 $ 100,647 $ 88,539 $ 12,108 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 5.1 million common shares of CASI Pharmaceuticals, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $4.0 million as of December 31, 2021. We completed the sale of 3.4 million shares of common stock and recognized a $5.7 million gain within “other expense, net” within the accompanying Consolidated Statements of Operations for the year ended December 31, 2021. Additionally, we hold 0.8 million common shares of Unicycive Therapeutics, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $1.7 million as of December 31, 2021. (b) Other Receivables “Other receivables” consists of the following: December 31, 2021 2020 Other miscellaneous receivables $ 685 $ 901 Employee receivable 341 — Income tax receivable - current portion — 1,297 Interest receivable from marketable securities 2 196 Other receivables $ 1,028 $ 2,394 (c) Prepaid Expenses and Other Current Assets “Prepaid expenses and other current assets” consists of the following: December 31, 2021 2020 Prepaid expenses and deferred costs $ 1,550 $ 1,996 Prepaid insurance 727 2,165 Prepaid expenses and other current assets $ 2,277 $ 4,161 (d) Property and Equipment, net “Property and equipment, net” consists of the following: December 31, 2021 2020 Manufacturing equipment $ — $ 3,245 Computer hardware and software 1,803 1,680 Laboratory equipment 5 5 Office furniture 317 248 Leasehold improvements 1,278 1,267 Property and equipment, at cost 3,403 6,445 (Less): Accumulated depreciation (2,948) (2,868) Property and equipment, net $ 455 $ 3,577 Depreciation expense was immaterial for the years ended December 31, 2021 and 2020, respectively. Manufacturing equipment was comprised of our owned eflapegrastim 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 eflapegrastim 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 eflapegrastim 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 year ended December 31, 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: December 31, 2021 2020 Trade accounts payable and other $ 33,408 $ 34,385 Lease liability - current portion 1,282 1,544 Commercial Product Portfolio accruals (Note 9) 6,568 7,842 Accounts payable and other accrued liabilities $ 41,258 $ 43,771 Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Consolidated Balance Sheets for our categories of gross-to-net (“GTN”) estimates related to the Commercial Product Portfolio accruals were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, 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 (1,159) — (115) (1,274) Balance as of December 31, 2021 $ 1,442 $ 942 $ 4,184 $ 6,568 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION 2018 Long-Term Incentive Plan We have one active stockholder-approved stock-based compensation plan, the 2018 Long-Term Incentive Plan (the “2018 Plan”). In June 2018, the 2018 Plan replaced our former 2009 Incentive Award Plan (the “2009 Plan”). Under the 2018 Plan, we may grant 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. Stock-based awards generally vest one-third on the first anniversary of the date of grant, and in equal annual installments thereafter over the remaining two years vesting period. Stock options must generally be exercised, if at all, no later than 10 years from the date of grant. In the event of a change in control, all award types with the exception of performance unit awards, will vest in full effective immediately prior to the consummation of the change in control. For performance unit awards, if a change in control occurs prior to the end date and the participant remains employed prior to the change in control, the shares vest based on the achievement of the performance goals as of the date of which the change in control occurs. The stated maximum availability of common stock under the 2018 Plan is 18 million shares, except for additional availability provided on a one-for-one basis for awards formerly issued under the 2009 Plan that are terminated, forfeited, cancelled or expire unexercised. Awards issued under the 2018 Plan reduce share availability on a one-to-one basis for stock options and on a 1.5-to-one basis for restricted stock awards and restricted stock units. Accordingly, as of December 31, 2021, 4.4 million awards were available for grant under the 2018 Plan, assuming all were issued in the form of stock options, but would be reduced to 3.0 million awards available for grant if all were issued in the form of restricted stock. It is our policy that before stock is issued through the exercise of stock options, we must first receive all required cash payment for such shares (whether through an upfront cash exercise or net-settlement exercise). At the time of vesting of restricted stock, by our policy, requisite shares are automatically sold on the open market by our designated broker to the extent required to cover the employee’s federal and state taxes due. Stock-based awards are governed by agreements between us and the recipients. Incentive stock options and nonqualified stock options may be granted under the 2018 Plan at an exercise price of not less than 100% of the fair market value of our common stock on the respective date of grant and for certain recipients may not be less than 110% of such fair market value. The grant date is generally the date the terms of the award are approved by the Compensation Committee of our Board of Directors. Employee Stock Purchase Plan Under the terms of our 2009 Employee Stock Purchase Plan (the “ESPP”), eligible employees can purchase common stock through scheduled payroll deductions. The purchase price is equal to the closing price of our common stock on the first or last day of the offering period (whichever is less), minus a 15% discount. We use the Black-Scholes option-pricing model, in combination with the discounted employee price, in determining the value of ESPP expense to be recognized during each offering period. A participant may purchase a maximum of 50,000 shares of common stock during a six-month offering period, not to exceed $25,000 at full market value on the offering date during each plan year. As of December 31, 2021, a total of 8.2 million shares of common stock are authorized and remain available for issuance under the ESPP. Beginning on January 1, 2010, and each January 1st thereafter, the number of shares of common stock available for issuance under the ESPP shall automatically increase by an amount equal to the lesser of (i) one million shares or (ii) an amount determined by the ESPP administrator. However, in no event shall the number of shares of common stock available for future sale under the ESPP exceed 10 million shares, subject to capitalization adjustments occurring due to dividends, splits, dissolution, liquidation, mergers, or changes in control. Stock-Based Compensation Expense Summary We report our stock-based compensation expense (inclusive of our incentive stock plan and employee stock purchase plan) in the accompanying Consolidated Statements of Operations within “total operating costs and expenses” for the years ended December 31, 2021 and 2020, as follows: Year Ended December 31, 2021 2020 Selling, general and administrative $ 14,642 $ 13,127 Research and development 5,197 4,692 Total stock-based compensation $ 19,839 $ 17,819 Employee stock-based compensation expense for the years ended December 31, 2021 and 2020 was recognized (reduced for estimated forfeitures) on a straight-line basis over the vesting period. Forfeitures are estimated at the time of grant and are prospectively revised if actual forfeitures differ from those estimates. We estimate forfeitures of stock options using the historical exercise behavior of our employees. For purposes of this estimate, we have applied an estimated forfeiture rate of 11% and 15% for the years ended December 31, 2021 and 2020, respectively. Valuation Assumptions The grant-date fair value per share for restricted stock awards was based upon the closing market price of our common stock on the award grant-date. The fair value of stock options granted was estimated at the date of grant using the Black-Scholes option-pricing model. The following assumptions were used to determine fair value for the stock awards granted in the applicable year: Year Ended December 31, 2021 2020 Expected option life (in years) (a) 5.57 5.46 Risk-free interest rate (b) 0.56% - 1.32% 0.34% - 1.61% Volatility (c) 80.0% - 82.7% 74.5% - 81.4% Dividend yield (d) 0% 0% Weighted-average grant-date fair value per stock option $1.78 $1.63 (a) Determined by the historical stock option exercise behavior of our employees (maximum term is 10 years). (b) Based upon the U.S. Treasury yields in effect during the period which the options were granted (for a period equaling the stock options’ expected term). (c) Measured using our historical stock price for a period equal to stock options’ expected term. (d) We do not expect to declare any cash dividends in the foreseeable future. Stock Option Activity Stock option activity during the years ended December 31, 2021 and 2020 was as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2019 6,439,936 $ 9.61 Granted 2,032,000 2.34 Exercised (3,542) 3.70 $ 708 (1) Forfeited (170,187) 8.29 Expired (641,584) 8.55 Outstanding — December 31, 2020 7,656,623 $ 7.80 Granted 2,397,684 2.66 Exercised (1,250) 3.04 $ 1.5 (1) Forfeited (34,565) 10.05 Expired (513,031) 9.29 Outstanding — December 31, 2021 9,505,461 $ 6.42 5.86 $ — (2) Vested (exercisable) — December 31, 2021 6,371,266 $ 8.04 4.26 $ — (2) Unvested (unexercisable) — December 31, 2021 3,134,195 $ 3.13 9.10 $ — (2) (1) Represents the total difference between our closing stock price at the time of exercise and the stock option exercise price, multiplied by the number of options exercised. (2) Represents the total difference between our closing stock price on the last trading day of 2021 and the stock option exercise price, multiplied by the number of in-the-money options as of December 31, 2021. The amount of intrinsic value will change based on the fair market value of our stock. The following table summarizes information with respect to stock option grants as of December 31, 2021: Outstanding Exercisable Exercise Price Granted Stock Weighted- Weighted- Granted Weighted- $1.29 - 4.96 4,397,491 7.6 $ 2.52 1,507,886 $ 2.58 $4.97 - 6.91 1,854,119 4.33 6.00 1,854,119 6.00 $6.92 - 9.00 1,376,034 3.41 7.80 1,300,617 7.77 $9.01 - 12.00 925,709 4.17 11.17 769,707 11.17 $12.01 - 22.64 952,108 5.99 18.61 938,937 18.63 9,505,461 5.86 $ 6.42 6,371,266 $ 8.04 As of December 31, 2021 , there was unrecognized compensation expense of $4.2 million related to unvested stock options, which we expect to recognize over a weighted average period of 2.1 years. For the year ended December 31, 2021 , we recorded stock option expense of $4.5 million related to issued stock options. Restricted Stock Award Activity A summary of restricted stock award activity is as follows: Number of Weighted Average Unvested — December 31, 2019 1,659,759 $ 11.67 Granted 4,026,518 2.68 Vested (753,475) 11.23 Forfeited (436,757) 6.03 Unvested — December 31, 2020 4,496,045 4.29 Granted 2,820,259 3.33 Vested (2,272,064) 5.06 Forfeited (608,233) 3.85 Unvested — December 31, 2021 4,436,007 $ 3.33 For the years ended December 31, 2021 and 2020, we recorded stock-based compensation expense on our issued restricted share awards of $9.6 million and $9.4 million, respectively. As of December 31, 2021, there was approximately $9.7 million of unrecorded expense that will be recognized over an estimated weighted average period of 1.9 years. These unvested shares are included in our reported issued and outstanding common stock as of December 31, 2021. Restricted Stock Unit Activity Our outstanding restricted stock units substantially relate to awards that contain “market-based” vesting conditions that are issued to our executive officers. These conditions are specified in each award agreement and result in a variable number of shares that become issuable at the assessment date, after review and approval by our Compensation Committee. A summary of restricted stock unit activity is as follows: Number of Weighted Average Outstanding — December 31, 2019 385,919 $ 18.00 Granted 6,800 2.36 Market-based achievement adjustment at vesting (128,334) — Share issuance (861) 10.69 Outstanding — December 31, 2020 263,524 26.39 Granted 2,125 3.61 Market-based achievement adjustment at vesting 75,000 — Share issuance (151,386) 28.09 Forfeited (4,751) 4.03 Outstanding — December 31, 2021 184,512 $ 23.53 For the years ended December 31, 2021 and 2020, we recorded stock-based compensation expense on our issued restricted stock units of $1.1 million and $1.1 million, respectively. As of December 31, 2021, there was an immaterial amount of unrecorded expense to be recognized. Stock Appreciation Rights During the years ended December 31, 2021 and 2020, we granted 2.1 million and 1.7 million stock appreciation rights (“SARs”), respectively, to our Named Executive Officers. On the date of grant, the fair value of these SARs were estimated using the Black-Scholes option-pricing model and 25% immediately vested. There were no forfeitures made during the year. We recognized stock-based compensation expense of $4.2 million and $1.5 million, respectively, within our Consolidated Statements of Operations for the years ended December 31, 2021 and 2020. As of December 31, 2021, there was approximately $1.9 million of unrecorded expense that will be recognized over an estimated weighted average period of 2.0 years. 401(k) Plan – Stock Matching Contribution Beginning in March 2020, employee 401(k) matching contributions were made with cash rather than stock on a prospective basis. As a result of this change, the shares issued to participants 401(k) accounts were substantially lower in the current year period compared to prior year periods. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Authorized Stock In June 2018, our stockholders approved an amendment and restatement of our Certificate of Incorporation to reflect an increase in the number of authorized shares of our common stock from 175 million shares to 300 million shares. In addition to the increase in the authorized number of shares of common stock, the amendment eliminates designated series of preferred stock that are obsolete and are no longer outstanding or issuable, including Series B Junior Participating Preferred Stock and Series E Convertible Voting Preferred Stock. As of December 31, 2021, we had five million shares of preferred stock authorized and no shares of preferred stock outstanding. Stockholder Rights Agreement On November 29, 2010, our Board of Directors approved a stockholder rights agreement (the “Stockholder Rights Agreement”), effective December 13, 2010. A stockholder rights agreement is designed to deter coercive, unfair, or inadequate takeovers and other abusive tactics that might be used in an attempt to gain control of our company. A stockholder rights agreement will not prevent takeovers at a full and fair price, but rather is designed to deter coercive takeover tactics and to encourage anyone attempting to acquire our company to first negotiate with our Board of Directors. On March 27, 2018, we entered into a Second Amendment to Rights Agreement which had the effect of suspending the Stockholders Rights Agreement as of March 30, 2018. On December 13, 2020, the Stockholder Rights Agreement expired under its terms. Share Grants Subject to Shareholder Approval In December 2021, we announced that Tom Riga would be our next President and Chief Executive Officer effective December 31, 2021 and join the Company’s Board of Directors upon assuming his new role. Prior to this appointment, he served as our Chief Commercial Officer and Chief Operating Officer. As a result of this announcement in January 2022, Mr. Riga was granted 1,078,500 stock options and 239,500 restricted stock units vesting one third on each of January 14, 2023, 2024, and 2025. These share grants are contingent upon shareholder approval during the next Annual Shareholder’s Meeting. Common Stock Issuable Upon Exercise of Stock Options and Vesting of Restricted Stock Units As of December 31, 2021, (i) 6.4 million shares of our common stock are issuable upon the exercise of outstanding stock options (regardless of whether in or out-of-the-money) and (ii) 0.4 million shares of our common stock are issuable if the maximum market conditions of our outstanding restricted stock unit agreements are met. Public Offering of Common Stock On July 30, 2020, we announced the pricing of an underwritten public offering of 21,666,667 shares of our common stock at a public offering price of $3.00 per share. The net proceeds from the offering were approximately $61.1 million, after deducting underwriting discounts and commissions. In addition, we granted the underwriters a 30-day option to purchase up to an additional 3,250,000 shares of common stock. On August 3, 2020, the underwriters fully exercised their option to purchase an additional 3,250,000 shares of our common stock at the public offering price of $3.00 per share, less underwriting discounts and commissions, for additional net proceeds of approximately $9.2 million. After giving effect to the exercise in full of the underwriters’ option, the total number of shares sold in the public offering was 24,916,667 shares and net proceeds were approximately $69.7 million, net of underwriting discounts and offering expenses of $5.0 million. Sale of Common Stock Under ATM Agreements On April 5, 2019, we entered into a new collective at-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: Description of Financing Transaction No. of Common Shares Issued Proceeds Received (Net of Broker Commissions and Fees ) Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2020 3,950,398 $ 14,902 Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2021 15,851,391 $ 52,621 These proceeds and any future proceeds raised will support the advancement of our in-development drug candidates, activities in connection with the launch of these drugs (including the hiring of personnel, building inventory supply and equipment purchases), completing acquisitions of assets, businesses, or securities, and for all other working capital purposes. |
Financial Commitments & Conting
Financial Commitments & Contingencies and Key License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Financial Commitments & Contingencies and Key License Agreements | FINANCIAL COMMITMENTS & 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 which expired on October 31, 2021 and was 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. 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 December 31, 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 year ended December 31, 2021 and 2020, we recognized $1.8 million and $0, respectively, of additional right-of-use assets in exchange for 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 Consolidated Balance Sheets: Operating Leases Consolidated Balance Sheet Caption December 31, 2021 December 31, 2020 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 2,505 $ 2,247 Operating lease liabilities - current Accounts payable and other accrued liabilities $ 1,282 $ 1,544 Operating lease liabilities - non-current Other long-term liabilities 1,452 883 Total operating lease liabilities $ 2,734 $ 2,427 As of December 31, 2021 and 2020, our “facility and equipment under lease” consisted of office and research faciliti es of $2.1 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 Consolidated Statements of Operations. The components of our aggregate lease expense is summarized below: Year Ended December 31, 2021 Year Ended December 31, 2020 Operating lease cost $ 1,711 $ 1,865 Variable lease cost 378 411 Short-term lease cost 63 61 Total lease cost $ 2,152 $ 2,337 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of December 31, 2021 2.7 years 3.8% 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 December 31, 2021 2022 $ 1,344 2023 657 2024 669 2025 98 2026 73 Total future lease payments, undiscounted $ 2,841 (Less): Implied interest (107) Present value of operating lease payments $ 2,734 (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. The most significant remaining agreements associated with our operations, along with the key financial terms and our corresponding accounting and reporting conventions for each, are as follows: (i) Eflapegrastim: 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 for eflapegrastim, 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 eflapegrastim development plan and hold its worldwide rights (except for Korea, China, and Japan). Effective January 1, 2022, we executed an amendment to this license agreement, whereby we are contractually obligated to pay Hanmi a flat mid-single digit royalty on our aggregate annual net sales of eflapegrastim. In addition, beginning from year three, we are responsible for a supplemental mid-single digit royalty on aggregate annual net sales. This supplemental royalty will terminate once the aggregate payments made to Hanmi meet the milestone limit of $10 million, based on the supplemental royalty. There were no obligations to Hanmi for the twelve months ended December 31, 2021. (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. Effective January 1, 2022, we executed an amendment to this in-license agreement, whereby the payments to Hanmi upon our achievement of various regulatory milestones now aggregate to $18 million, which includes eliminating the first approval milestone payment in return for a supplemental mid-single digit royalty on aggregate annual net sales beginning in year three after the commercial launch. This supplemental royalty will terminate once the aggregate payments made to Hanmi meet the milestone limit of $15 million, based on the supplemental royalty. There were no contractual obligations to Hanmi under the previous agreement for the twelve months ended December 31, 2021. 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. In November 2021, we provided notice to terminate the asset transfer, license, and sublicense agreement with ImmunGene, Inc. Pursuant to the agreement, we will transfer the rights, title or interest with respect to the transferred product back to ImmunGene. There were no contractual obligations to ImmunGene for the twelve months ended December 31, 2021. 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. (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. We previously entered into an employment agreement with our former Chief Executive Officer, Joseph Turgeon, under which cash compensation and benefits would become payable in the event of termination by us for any reason other than cause, his resignation for good reason, or upon a change in control of our Company. Effective December 31, 2021, Mr. Turgeon’s employment with the Company was terminated without cause in accordance with his employment agreement. We have accrued for all contractual amounts due and unpaid to Mr. Turgeon as of December 31, 2021 within "accrued payroll and benefits" on the accompanying Consolidated Balance Sheets. (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 December 31, 2021 and 2020, the aggregate value of this DC Plan liability was $11.2 million and $9.8 million, respectively, and is included within “accounts payable and other accrued liabilities” and “other long-term liabilities” in the accompanying 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 eflapegrastim would, if approved, infringe claims of three patents owned by Bioverativ (the “Subject Patents”). Bioverativ sought an unspecified amount of damages and injunctive relief. Pursuant to our agreements with Hanmi, we hold worldwide rights (except for Korea, China, and Japan) to develop and commercialize eflapegrastim. 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. Related to the Bioverativ litigation, on December 20, 2021, we were named as respondents in an International Trade Commission (ITC) action filed in the ITC. The complaint alleged importation into the United States, the sale for importation, and the sale within the United States after importation of certain monomer-dimer hybrid immunoconjugates in violation of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337). On February 18, 2022, Spectrum, Hanmi and Bioverativ entered into a license and settlement agreement which included a stipulation to dismiss the Bioverativ litigation and withdraw the ITC complaint. On February 18, 2022, the ITC action against us was withdrawn, and on March 2, 2022, the Bioverativ case was dismissed by the U.S. District Court. Luo v. Spectrum Pharmaceuticals, Inc., et al. . 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 eflapegrastim 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. Csaba v. Spectrum Pharmaceuticals, Inc., et al. On December 15, 2021, a stockholder derivative complaint was filed against us, certain of our executive officers, and certain of our past and present members of the board of directors. The stockholder derivative complaint alleges that certain of our executive officers are liable to Spectrum, pursuant to Section 10(b) and 21(d) of the Securities Exchange Act of 1934, as amended, for contribution and indemnification, if they are deemed (in the Luo class action), to have 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 eflapegrastim. The complaint further alleges that certain of our executive officers and certain of our past and present directors breached their fiduciary duties, and certain of our present directors negligently violated Section 14(a) of the Exchange Act, by allegedly causing such false or misleading statements to be issued and/or failing to disclose material facts about our business and the prospects of approval for our BLA to the FDA for eflapegrastim. The allegations state that as a result of the violations, certain of our executive officers and past and present board members were unjustly enriched. The plaintiffs seek corporate reforms, 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. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES The components of loss before benefit for income taxes from continuing operations are as follows: Year Ended December 31, 2021 2020 United States $ (158,552) $ (173,398) Foreign 120 2,066 Total $ (158,432) $ (171,332) The benefit for income taxes from continuing operations consist of the following: Year Ended December 31, 2021 2020 Current: Federal $ — $ — State — (76) Foreign 4 16 $ 4 $ (60) Deferred: Federal — — State — — — — Total income tax expense (benefit) $ 4 $ (60) For the fiscal year ended December 31, 2021, we generated losses from continuing operations and recognized $4 of tax expense from our foreign continuing operations during the year ended December 31, 2021. The intraperiod allocation is not applicable for the years ended December 31, 2021 and 2020 as a result of the early adoption of ASU 2019-12 . The income tax benefit differs from that computed using the applicable federal statutory rate, as applied to our income before taxes in each year as follows: Year Ended December 31, 2021 2020 Tax provision computed at the federal statutory rate $ (33,210) $ (35,980) State tax, net of federal benefit (11,050) (5,142) Research and development expense tax credits (1,838) (2,686) Change in uncertain tax benefit reserve — (27) Change in tax credit carryforwards — 109 Officers compensation 1,988 2,497 Stock based compensation 1,234 1,619 Permanent items and other (173) (37) Tax differential on foreign earnings — (1) Change in tax rate (6,671) (1,091) Change in prior year deferred taxes (353) (998) Valuation allowance 50,077 41,677 Income tax expense (benefit) $ 4 $ (60) Significant components of our deferred tax assets and liabilities as of December 31, 2021 and 2020 are presented below. A valuation allowance has been recognized to offset the net deferred tax assets as realization of such deferred tax assets did not meet our “more-likely-than-not” assessment threshold, as required under GAAP. December 31, 2021 2020 Deferred tax assets: Net operating loss carry forwards $ 187,129 $ 143,045 Research and development expense tax credits 27,341 25,424 Stock based compensation 5,470 4,037 Lease obligation 783 599 Development costs 286 487 Returns and allowances 1,198 1,061 Amortization differences 1,749 1,479 Depreciation 57 4,746 Other, net 20,267 17,420 Total deferred tax assets before valuation allowance 244,280 198,298 Valuation allowance (242,590) (192,513) Total deferred tax assets 1,690 5,785 Deferred tax liabilities, net: Unrealized gains (973) (5,230) Right-of-use asset (717) (555) Net deferred tax liabilities $ — $ — At December 31, 2021 and 2020, we recorded a valuation allowance of $242.6 million and $192.5 million, respectively. The valuation allowance increased by $50.1 million and $39.5 million during 2021 and 2020, respectively. The increases in the valuation allowance in 2021 and 2020 were mostly due to an increase in net operating loss carryforwards. We had federal and state net operating loss carryforwards of approximately $746.6 million and $545.5 million, at December 31, 2021, respectively. We have approximately $0.5 million of foreign loss carryforwards that will begin to expire in 2039. The federal and state loss carry forwards began to expire in 2022 unless previously utilized, of which approximately $93.1 million of federal loss carryforwards expire in the next five years. Federal loss carryforwards generated in 2018 and beyond will be carried forward indefinitely. At December 31, 2021, we had federal and state tax credits of approximately $19.0 million and $10.6 million, respectively. The federal tax credit carryovers begin to expire in 2027 unless previously utilized. The state research and development credit carryforwards have an indefinite carryover period. Our utilization of certain net operating loss and research and development expense tax credit carryforwards, including those acquired in connection with the acquisition of Allos Therapeutics, Inc. in April 2012 and Talon Therapeutics, Inc. in July 2016, are subject to annual limitations under Sections 382 and 383 of the Internal Revenue Code of 1986 and similar state provisions. Any net operating losses or credits that would expire unutilized as a result of Section 382 and 383 limitations have been removed from the table of deferred tax assets and the accompanying disclosures of net operating loss and research and development carryforwards. The following tabular reconciliation summarizes the activity related to our unrecognized tax benefits: Year Ended December 31, 2021 2020 Balance at beginning of year $ 3,336 $ 3,473 Adjustments related to prior year tax positions (318) (689) Increases related to current year tax positions 506 579 Decreases due to expiration of tax statutes — (27) Balance at end of year $ 3,524 $ 3,336 We continue to believe that our tax positions meet the “more-likely-than-not” standard and as part of that analysis, we considered the amounts and probabilities from ultimate settlement with the tax authorities. Approximately $0.0 million and $0.1 million of the total unrecognized tax benefits as of December 31, 2021 and 2020, respectively, would reduce our annual effective tax rate if recognized. Additional amounts in the summary rollforward could impact our effective tax rate if we did not maintain a full valuation allowance on our net deferred tax assets. We do not expect our unrecognized tax benefits to change significantly over the next 12 months. With a few exceptions, we are no longer subject to U.S. federal, state and local income tax examinations for years before 2017. Our policy is to recognize interest and/or penalties related to unrecognized tax benefits in income tax expense in the Consolidated Statements of Operations. On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, a $2 trillion relief package comprised of a combination of tax provisions and other stimulus measures. The CARES Act broadly provides entities tax payment relief and significant business incentives and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act, or the Tax Act. The tax relief measures for entities include a five-year net operating loss carry back, increased interest expense deduction limits, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property. The CARES Act also provides other non-income tax benefits, including federal funding for a range of stabilization measures and emergency funding to assist those impacted by the COVID-19 pandemic. Similar legislation is being enacted in other jurisdictions in which the Company operates. ASC Topic 740, Income Taxes, requires the effect of changes in tax law be recognized in the period in which new legislation is enacted. The enactment of the CARES Act and similar legislation in other jurisdictions in which the Company operates is not expected to have a material impact on its consolidated financial position and results of operations as of December 31, 2021. Early Adoption of ASU 2019-12 — Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes 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 |
Discontinued Operations
Discontinued Operations | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | DISCONTINUED OPERATIONS Overview 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. 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 Consolidated Financial Statements reflect the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations”. 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 Consolidated Statements of Operations: Year ended December 31, 2021 2020 Revenues: Product sales, net $ — $ 10,668 Total revenues $ — $ 10,668 Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) 133 88 Selling, general and administrative — 219 Research and development 59 (43) Total operating costs and expenses $ 192 $ 264 Income (loss) from discontinued operations before income taxes (192) 10,404 Provision for income taxes from discontinued operations — — Income (loss) from discontinued operations, net of income taxes $ (192) $ 10,404 For the year ended December 31, 2018, management identified certain immaterial errors aggregating to $12.0 million that substantially relates to ZEVALIN rebates owed to qualifying Public Health Service (“PHS”) hospitals from 2009 through the first quarter of 2019. On July 3, 2020, pursuant to communications we had with the Health Resources and Services Administration (“HRSA”), we posted a notification on the HRSA website with instructions for PHS customers on how to make claims with the Company for refunds for the additional rebate amounts they may be eligible for and no claims were made by customers. Accordingly, we recorded a reduction to government chargebacks liability of $10.8 million in 2020, which was recognized within the “Product sales, net” caption of the Consolidated Statements of Operations for discontinued operations. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 10. SUBSEQUENT EVENTS During January 2022, the Company entered into a Securities Purchase Agreement with Hanmi, pursuant to which Hanmi purchased 12,500,000 shares of our common shares at a purchase price of $1.60 per share, for an aggregate purchase price equal to $20 million. In addition, the Company entered into amendments to the licensing agreements for both eflapegrastim and poziotinib, which resulted in the conversion of the upfront milestone payments for both products to deferred royalties. The royalty obligation for eflapegrastim changed to mid-single digits as a percent of sales for a specified period. The amended agreement eliminated poziotinib’s approval milestone payment in return for a supplemental royalty that will continue until the milestone is fully paid, based on the supplemental royalty. The companies also agreed to an amended supply arrangement that is expected to result in a lower cost of goods sold for Spectrum (See Note 7 Commitments and Contingencies for further discussion). In addition, Hanmi has agreed to release the Company from a prior purchase obligation for eflapegrastim drug substance which will result in a reduction in accrued liabilities of $11.2 million with a corresponding reduction in research and development expense. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2021 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts |
Description of Business, Basi_2
Description of Business, Basis of Presentation, and Operating Segment (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [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 two drugs in late-stage development: • Eflapegrastim, a novel long-acting granulocyte colony-stimulating factor (“G-CSF”) for the treatment of chemotherapy-induced neutropenia. On August 6, 2021, the Company announced the receipt of a complete response letter (“CRL”), that cited manufacturing deficiencies related both to the drug substance and drug product manufacturers. The Company believes it has completed the remediation of these deficiencies and resubmitted the Biologics License Application (“BLA”) on March 11, 2022; • Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations. On December 6, 2021, the Company announced it submitted its New Drug Application (“NDA”) for poziotinib to the FDA for use in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations. The NDA submission is based on the positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib. The product has received Fast Track designation and there is currently no treatment specifically approved by the FDA for this indication. On February 11, 2022, the Company announced that it had received notice that the NDA had been accepted and received a PDUFA action date of November 24, 2022. |
Basis of Presentation | Basis of Presentation Principles of Consolidation The accompanying Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and with the rules and regulations of the Securities and Exchange Commission (“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 December 31, 2021. Discontinued Operations - Sale of our Commercial Product Portfolio In March 2019, we completed the Commercial Product Portfolio Transaction (See Note 9 ). 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 Consolidated Statements of Operations. Liquidity and Capital Resources |
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 years ended December 31, 2021 and 2020, all of our operating costs and expenses were solely attributable to these activities (and as applicable, classified as “discontinued” within the accompanying Consolidated Statements of Operations). |
Use of Estimates and Assumptions | 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 Consolidated Financial Statements are further described below: |
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 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 Consolidated Statements of Operations and (2) unrealized gains (losses) are recognized as a component of “accumulated other comprehensive loss” within the Consolidated Statements of Stockholders’ Equity. |
Property and Equipment, Net | 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 impairments that occurred during the year ended December 31, 2020. There were no impairments recorded during the year ended December 31, 2021. |
Stock-Based Compensation | Stock-Based CompensationStock-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 Consolidated Statements of Operations for the period in which we received the notice. |
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 MeasurementsWe 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. Level 3: Unobservable inputs are used when little or no market data is available. |
Recently Issued Accounting Standards | Recently Issued Accounting StandardsThere are several new accounting pronouncements issued by the FASB, which we don’t believe had or will have a material impact on our consolidated financial statements.Early Adoption of ASU 2019-12 — Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes 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 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 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 Consolidated Balance Sheets, and their designations among the three fair value measurement categories: December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 66,322 $ — $ — $ 66,322 Equity securities 5,718 — — 5,718 Mutual funds 6,390 9 — 6,399 Key employee life insurance, cash surrender value (1) — 4,507 — 4,507 $ 78,430 $ 4,516 $ — $ 82,946 Liabilities: Deferred executive compensation liability (2) $ — $ 11,243 $ — $ 11,243 $ — $ 11,243 $ — $ 11,243 (1) Included within other assets on our 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 $2.0 million within accounts payable and other accrued liabilities and $9.2 million within other long-term liabilities on our Consolidated Balance Sheets. December 31, 2020 Level 1 Level 2 Level 3 Total Assets: Equity securities $ 24,946 $ — $ — $ 24,946 Money market funds 40,560 — — 40,560 Government-related debt securities 92,928 — — 92,928 Corporate debt securities — 8,848 — 8,848 Mutual funds 5,573 9 — 5,582 Bank CDs — 1,721 — 1,721 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 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 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) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule 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 Value Cash and Cash Marketable Securities December 31, 2021 Money market funds $ 66,322 $ 66,322 $ 66,322 $ — Equity securities (1) 3,512 5,718 — 5,718 Mutual funds 5,218 6,390 — 6,390 Bank deposits 22,217 22,217 22,217 — Total cash and cash equivalents and marketable securities $ 97,269 $ 100,647 $ 88,539 $ 12,108 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 5.1 million common shares of CASI Pharmaceuticals, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $4.0 million as of December 31, 2021. We completed the sale of 3.4 million shares of common stock and recognized a $5.7 million |
Schedule of Other Receivables | “Other receivables” consists of the following: December 31, 2021 2020 Other miscellaneous receivables $ 685 $ 901 Employee receivable 341 — Income tax receivable - current portion — 1,297 Interest receivable from marketable securities 2 196 Other receivables $ 1,028 $ 2,394 |
Schedule of Prepaid Expenses and Other Assets | “Prepaid expenses and other current assets” consists of the following: December 31, 2021 2020 Prepaid expenses and deferred costs $ 1,550 $ 1,996 Prepaid insurance 727 2,165 Prepaid expenses and other current assets $ 2,277 $ 4,161 |
Schedule of Property and Equipment, net | “Property and equipment, net” consists of the following: December 31, 2021 2020 Manufacturing equipment $ — $ 3,245 Computer hardware and software 1,803 1,680 Laboratory equipment 5 5 Office furniture 317 248 Leasehold improvements 1,278 1,267 Property and equipment, at cost 3,403 6,445 (Less): Accumulated depreciation (2,948) (2,868) Property and equipment, net $ 455 $ 3,577 Depreciation expense was immaterial for the years ended December 31, 2021 and 2020, respectively. |
Schedule of Accounts Payable and Other Accrued Liabilities | “Accounts payable and other accrued liabilities” consists of the following: December 31, 2021 2020 Trade accounts payable and other $ 33,408 $ 34,385 Lease liability - current portion 1,282 1,544 Commercial Product Portfolio accruals (Note 9) 6,568 7,842 Accounts payable and other accrued liabilities $ 41,258 $ 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 Consolidated Balance Sheets for our categories of gross-to-net (“GTN”) estimates related to the Commercial Product Portfolio accruals were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, 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 (1,159) — (115) (1,274) Balance as of December 31, 2021 $ 1,442 $ 942 $ 4,184 $ 6,568 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule 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 Consolidated Statements of Operations within “total operating costs and expenses” for the years ended December 31, 2021 and 2020, as follows: Year Ended December 31, 2021 2020 Selling, general and administrative $ 14,642 $ 13,127 Research and development 5,197 4,692 Total stock-based compensation $ 19,839 $ 17,819 |
Schedule of Fair Value of Stock Options Granted Using Black-Scholes Option Pricing Model | The fair value of stock options granted was estimated at the date of grant using the Black-Scholes option-pricing model. The following assumptions were used to determine fair value for the stock awards granted in the applicable year: Year Ended December 31, 2021 2020 Expected option life (in years) (a) 5.57 5.46 Risk-free interest rate (b) 0.56% - 1.32% 0.34% - 1.61% Volatility (c) 80.0% - 82.7% 74.5% - 81.4% Dividend yield (d) 0% 0% Weighted-average grant-date fair value per stock option $1.78 $1.63 (a) Determined by the historical stock option exercise behavior of our employees (maximum term is 10 years). (b) Based upon the U.S. Treasury yields in effect during the period which the options were granted (for a period equaling the stock options’ expected term). (c) Measured using our historical stock price for a period equal to stock options’ expected term. (d) We do not expect to declare any cash dividends in the foreseeable future. |
Schedule of Stock Option Activity | Stock option activity during the years ended December 31, 2021 and 2020 was as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2019 6,439,936 $ 9.61 Granted 2,032,000 2.34 Exercised (3,542) 3.70 $ 708 (1) Forfeited (170,187) 8.29 Expired (641,584) 8.55 Outstanding — December 31, 2020 7,656,623 $ 7.80 Granted 2,397,684 2.66 Exercised (1,250) 3.04 $ 1.5 (1) Forfeited (34,565) 10.05 Expired (513,031) 9.29 Outstanding — December 31, 2021 9,505,461 $ 6.42 5.86 $ — (2) Vested (exercisable) — December 31, 2021 6,371,266 $ 8.04 4.26 $ — (2) Unvested (unexercisable) — December 31, 2021 3,134,195 $ 3.13 9.10 $ — (2) (1) Represents the total difference between our closing stock price at the time of exercise and the stock option exercise price, multiplied by the number of options exercised. |
Schedule of Stock Option Grants | The following table summarizes information with respect to stock option grants as of December 31, 2021: Outstanding Exercisable Exercise Price Granted Stock Weighted- Weighted- Granted Weighted- $1.29 - 4.96 4,397,491 7.6 $ 2.52 1,507,886 $ 2.58 $4.97 - 6.91 1,854,119 4.33 6.00 1,854,119 6.00 $6.92 - 9.00 1,376,034 3.41 7.80 1,300,617 7.77 $9.01 - 12.00 925,709 4.17 11.17 769,707 11.17 $12.01 - 22.64 952,108 5.99 18.61 938,937 18.63 9,505,461 5.86 $ 6.42 6,371,266 $ 8.04 |
Schedule of Restricted Stock Award and Restricted Stock Units Activity | A summary of restricted stock award activity is as follows: Number of Weighted Average Unvested — December 31, 2019 1,659,759 $ 11.67 Granted 4,026,518 2.68 Vested (753,475) 11.23 Forfeited (436,757) 6.03 Unvested — December 31, 2020 4,496,045 4.29 Granted 2,820,259 3.33 Vested (2,272,064) 5.06 Forfeited (608,233) 3.85 Unvested — December 31, 2021 4,436,007 $ 3.33 Number of Weighted Average Outstanding — December 31, 2019 385,919 $ 18.00 Granted 6,800 2.36 Market-based achievement adjustment at vesting (128,334) — Share issuance (861) 10.69 Outstanding — December 31, 2020 263,524 26.39 Granted 2,125 3.61 Market-based achievement adjustment at vesting 75,000 — Share issuance (151,386) 28.09 Forfeited (4,751) 4.03 Outstanding — December 31, 2021 184,512 $ 23.53 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Schedule of Stock by Class | We sold and issued common shares under the April 2019 ATM Agreement as follows: Description of Financing Transaction No. of Common Shares Issued Proceeds Received (Net of Broker Commissions and Fees ) Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2020 3,950,398 $ 14,902 Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2021 15,851,391 $ 52,621 |
Financial Commitments & Conti_2
Financial Commitments & Contingencies and Key License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Lease Assets and Liabilities | The below table summarizes the lease asset and liability accounts presented on our accompanying Consolidated Balance Sheets: Operating Leases Consolidated Balance Sheet Caption December 31, 2021 December 31, 2020 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 2,505 $ 2,247 Operating lease liabilities - current Accounts payable and other accrued liabilities $ 1,282 $ 1,544 Operating lease liabilities - non-current Other long-term liabilities 1,452 883 Total operating lease liabilities $ 2,734 $ 2,427 |
Schedule of Aggregate Lease Expense | The components of our aggregate lease expense is summarized below: Year Ended December 31, 2021 Year Ended December 31, 2020 Operating lease cost $ 1,711 $ 1,865 Variable lease cost 378 411 Short-term lease cost 63 61 Total lease cost $ 2,152 $ 2,337 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of December 31, 2021 2.7 years 3.8% Operating leases as of December 31, 2020 1.6 years 7.8% |
Schedule of 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 December 31, 2021 2022 $ 1,344 2023 657 2024 669 2025 98 2026 73 Total future lease payments, undiscounted $ 2,841 (Less): Implied interest (107) Present value of operating lease payments $ 2,734 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Loss before Benefit for Income Taxes | The components of loss before benefit for income taxes from continuing operations are as follows: Year Ended December 31, 2021 2020 United States $ (158,552) $ (173,398) Foreign 120 2,066 Total $ (158,432) $ (171,332) |
Schedule of Benefit from Income Taxes | The benefit for income taxes from continuing operations consist of the following: Year Ended December 31, 2021 2020 Current: Federal $ — $ — State — (76) Foreign 4 16 $ 4 $ (60) Deferred: Federal — — State — — — — Total income tax expense (benefit) $ 4 $ (60) |
Schedule of Income Tax Benefit Differs from Computed Using Federal Statutory Rate Applied to Income before Taxes | The income tax benefit differs from that computed using the applicable federal statutory rate, as applied to our income before taxes in each year as follows: Year Ended December 31, 2021 2020 Tax provision computed at the federal statutory rate $ (33,210) $ (35,980) State tax, net of federal benefit (11,050) (5,142) Research and development expense tax credits (1,838) (2,686) Change in uncertain tax benefit reserve — (27) Change in tax credit carryforwards — 109 Officers compensation 1,988 2,497 Stock based compensation 1,234 1,619 Permanent items and other (173) (37) Tax differential on foreign earnings — (1) Change in tax rate (6,671) (1,091) Change in prior year deferred taxes (353) (998) Valuation allowance 50,077 41,677 Income tax expense (benefit) $ 4 $ (60) |
Schedule of Components of Company's Deferred Tax Assets | Significant components of our deferred tax assets and liabilities as of December 31, 2021 and 2020 are presented below. A valuation allowance has been recognized to offset the net deferred tax assets as realization of such deferred tax assets did not meet our “more-likely-than-not” assessment threshold, as required under GAAP. December 31, 2021 2020 Deferred tax assets: Net operating loss carry forwards $ 187,129 $ 143,045 Research and development expense tax credits 27,341 25,424 Stock based compensation 5,470 4,037 Lease obligation 783 599 Development costs 286 487 Returns and allowances 1,198 1,061 Amortization differences 1,749 1,479 Depreciation 57 4,746 Other, net 20,267 17,420 Total deferred tax assets before valuation allowance 244,280 198,298 Valuation allowance (242,590) (192,513) Total deferred tax assets 1,690 5,785 Deferred tax liabilities, net: Unrealized gains (973) (5,230) Right-of-use asset (717) (555) Net deferred tax liabilities $ — $ — |
Schedule of Unrecognized Tax Benefits | The following tabular reconciliation summarizes the activity related to our unrecognized tax benefits: Year Ended December 31, 2021 2020 Balance at beginning of year $ 3,336 $ 3,473 Adjustments related to prior year tax positions (318) (689) Increases related to current year tax positions 506 579 Decreases due to expiration of tax statutes — (27) Balance at end of year $ 3,524 $ 3,336 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of 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 Consolidated Statements of Operations: Year ended December 31, 2021 2020 Revenues: Product sales, net $ — $ 10,668 Total revenues $ — $ 10,668 Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) 133 88 Selling, general and administrative — 219 Research and development 59 (43) Total operating costs and expenses $ 192 $ 264 Income (loss) from discontinued operations before income taxes (192) 10,404 Provision for income taxes from discontinued operations — — Income (loss) from discontinued operations, net of income taxes $ (192) $ 10,404 |
Description of Business, Basi_3
Description of Business, Basis of Presentation, and Operating Segment (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Jan. 31, 2022USD ($) | Dec. 31, 2021USD ($)segmentproduct | Dec. 31, 2020USD ($) | |
Subsidiary, Sale of Stock [Line Items] | |||
Number of late stage development drugs | product | 2 | ||
Cash, cash equivalents, and short-term investments | $ 100,647 | $ 180,025 | |
Number of reportable operating segment | segment | 1 | ||
Hanmi | Subsequent Event | |||
Subsidiary, Sale of Stock [Line Items] | |||
Equity financing received | $ 20,000 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Use of Estimates - (Details) - shares shares in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | ||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 13.5 | 9.6 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Asset and Liability Fair Values (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets: | ||
Equity securities | $ 5,718 | $ 24,946 |
Key employee life insurance, cash surrender value | 4,507 | 3,963 |
Total Assets | 82,946 | 178,548 |
Liabilities: | ||
Deferred executive compensation liability | 11,243 | 9,783 |
Total Liabilities | 11,243 | 9,783 |
Money market funds | ||
Assets: | ||
Available-for-sale | 66,322 | 40,560 |
Government-related debt securities | ||
Assets: | ||
Available-for-sale | 92,928 | |
Corporate debt securities | ||
Assets: | ||
Available-for-sale | 8,848 | |
Mutual funds | ||
Assets: | ||
Available-for-sale | 6,399 | 5,582 |
Bank CDs | ||
Assets: | ||
Available-for-sale | 1,721 | |
Level 1 | ||
Assets: | ||
Equity securities | 5,718 | 24,946 |
Key employee life insurance, cash surrender value | 0 | 0 |
Total Assets | 78,430 | 164,007 |
Liabilities: | ||
Deferred executive compensation liability | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 1 | Money market funds | ||
Assets: | ||
Available-for-sale | 66,322 | 40,560 |
Level 1 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 92,928 | |
Level 1 | Corporate debt securities | ||
Assets: | ||
Available-for-sale | 0 | |
Level 1 | Mutual funds | ||
Assets: | ||
Available-for-sale | 6,390 | 5,573 |
Level 1 | Bank CDs | ||
Assets: | ||
Available-for-sale | 0 | |
Level 2 | ||
Assets: | ||
Equity securities | 0 | 0 |
Key employee life insurance, cash surrender value | 4,507 | 3,963 |
Total Assets | 4,516 | 14,541 |
Liabilities: | ||
Deferred executive compensation liability | 11,243 | 9,783 |
Total Liabilities | 11,243 | 9,783 |
Level 2 | Accounts Payable and Accrued Liabilities | ||
Liabilities: | ||
Deferred executive compensation liability | 2,000 | 1,300 |
Level 2 | Other long-term liabilities | ||
Liabilities: | ||
Deferred executive compensation liability | 9,200 | 8,500 |
Level 2 | Money market funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 2 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 0 | |
Level 2 | Corporate debt securities | ||
Assets: | ||
Available-for-sale | 8,848 | |
Level 2 | Mutual funds | ||
Assets: | ||
Available-for-sale | 9 | 9 |
Level 2 | Bank CDs | ||
Assets: | ||
Available-for-sale | 1,721 | |
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 | |
Level 3 | Corporate debt securities | ||
Assets: | ||
Available-for-sale | 0 | |
Level 3 | Mutual funds | ||
Assets: | ||
Available-for-sale | $ 0 | 0 |
Level 3 | Bank CDs | ||
Assets: | ||
Available-for-sale | $ 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 | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | $ 3,512 | $ 3,764 |
Historical or Amortized Cost | 97,269 | 157,712 |
Equity securities | 5,718 | 24,946 |
Cash, cash equivalents, and short-term investments | 100,647 | 180,025 |
Level 1 | ||
Schedule of Investments [Line Items] | ||
Equity securities | $ 5,718 | 24,946 |
CASI Common Stock | ||
Schedule of Investments [Line Items] | ||
Number of shares held in investment (in shares) | 5.1 | |
Number of common shares sale in investments (in shares) | 3.4 | |
Realized gain on equity securities | $ 5,700 | |
CASI Common Stock | Level 1 | ||
Schedule of Investments [Line Items] | ||
Equity securities | 4,000 | |
Unicycive Therapeutics, Inc. | ||
Schedule of Investments [Line Items] | ||
Equity securities | $ 1,700 | |
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 | 88,539 | 46,009 |
Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Equity securities | 5,718 | 24,946 |
Cash, cash equivalents, and short-term investments | 12,108 | 134,016 |
Money market funds | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 66,322 | 40,560 |
Available-for-sale | 66,322 | 40,560 |
Money market funds | Cash and Cash Equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 66,322 | 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 | 92,881 | |
Available-for-sale | 92,928 | |
Government-related debt securities | Cash and Cash Equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 0 | |
Government-related debt securities | Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 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 | 5,218 | 4,497 |
Available-for-sale | 6,390 | 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 | 6,390 | 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 | 22,217 | 5,449 |
Available-for-sale | 22,217 | 5,449 |
Bank deposits | Cash and Cash Equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 22,217 | 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 | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Other miscellaneous receivables | $ 685 | $ 901 |
Employee receivable | 341 | 0 |
Income tax receivable - current portion | 0 | 1,297 |
Interest receivable from marketable securities | 2 | 196 |
Other receivables | $ 1,028 | $ 2,394 |
Balance Sheet Account Detail _3
Balance Sheet Account Detail - Prepaid Expenses and Other Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Prepaid expenses and deferred costs | $ 1,550 | $ 1,996 |
Prepaid insurance | 727 | 2,165 |
Prepaid expenses and other current assets | $ 2,277 | $ 4,161 |
Balance Sheet Account Detail _4
Balance Sheet Account Detail - Schedule of Property and Equipment Net of Accumulated Depreciation (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 3,403 | $ 6,445 |
(Less): Accumulated depreciation | (2,948) | (2,868) |
Property and equipment, net | 455 | 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 | 1,803 | 1,680 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 5 | 5 |
Office furniture | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 317 | 248 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 1,278 | $ 1,267 |
Balance Sheet Account Detail _5
Balance Sheet Account Detail - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Impairment of second source manufacturer | $ 2.9 | $ 19.7 |
Balance Sheet Account Detail _6
Balance Sheet Account Detail - Schedule of Accounts Payable and Other Accrued Obligations (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other | $ 33,408 | $ 34,385 |
Lease liability - current portion | 1,282 | 1,544 |
Commercial Product Portfolio accruals (Note 9) | 6,568 | 7,842 |
Accounts payable and other accrued liabilities | $ 41,258 | $ 43,771 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accounts payable and other accrued liabilities | Accounts payable and other accrued liabilities |
Balance Sheet Account Detail _7
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Obligations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounts Payable And Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | $ 7,842 | $ 20,523 |
(Less): Payments and credits against GTN accruals | (1,274) | (12,681) |
Ending balance | 6,568 | 7,842 |
Commercial/Medicaid Rebates and Government Chargebacks | ||
Accounts Payable And Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | 2,601 | 14,671 |
(Less): Payments and credits against GTN accruals | (1,159) | (12,070) |
Ending balance | 1,442 | 2,601 |
Distribution, Data, Inventory, and GPO Administrative Fees | ||
Accounts Payable And Other Accrued 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 Accrued Liabilities [Roll Forward] | ||
Beginning balance | 4,299 | 4,714 |
(Less): Payments and credits against GTN accruals | (115) | (415) |
Ending balance | $ 4,184 | $ 4,299 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2021USD ($)planshares | Dec. 31, 2020USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of stock incentive plans | plan | 1 | |
Vesting period | 3 years | |
Estimated forfeiture rate | 11.00% | 15.00% |
Forfeited (in shares) | 34,565 | 170,187 |
Total stock-based compensation | $ | $ 19,839,000 | $ 17,819,000 |
401(k) Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock issued (in shares) | 0 | 96,959 |
Stock-based compensation expense | $ | $ 300,000 | |
Vesting percent year one | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting percent | 33.333% | |
Vesting percent year two | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting percent | 33.333% | |
Vesting percent year three | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting percent | 33.333% | |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense | $ | $ 4,200,000 | $ 4,500,000 |
Weighted average period to recognize compensation expense | 2 years 1 month 6 days | 2 years 1 month 6 days |
Restricted Share Awards | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares available (in percent) | 1.5 | |
Unrecognized compensation expense | $ | $ 9,700,000 | |
Weighted average period to recognize compensation expense | 1 year 10 months 24 days | |
Restricted stock or unit expense | $ | $ 9,600,000 | $ 9,400,000 |
Granted (in shares) | 2,820,259 | 4,026,518 |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares available (in percent) | 1.5 | |
Restricted stock or unit expense | $ | $ 1,100,000 | $ 1,100,000 |
Granted (in shares) | 2,125 | 6,800 |
SARs | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting percent | 25.00% | |
Unrecognized compensation expense | $ | $ 1,900,000 | |
Weighted average period to recognize compensation expense | 2 years | |
Granted (in shares) | 2,100,000 | 1,700,000 |
Forfeited (in shares) | 0 | |
Total stock-based compensation | $ | $ 4,200,000 | $ 1,500,000 |
2018 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expiration period | 10 years | |
Common stock authorized for issuance under incentive plan (in shares) | 18,000,000 | |
Incentive awards available for grant (in shares) | 4,400,000 | |
Exercise price fair value | 100.00% | |
2018 Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise price fair value | 110.00% | |
2018 Plan | Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares available (in percent) | 0.01 | |
2018 Plan | Restricted Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Incentive awards available for grant (in shares) | 3,000,000 | |
2009 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares available (in percent) | 0.01 | |
ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock authorized for issuance under incentive plan (in shares) | 8,200,000 | |
Incentive awards available for grant (in shares) | 10,000,000 | |
Percentage of common stock purchase price | 15.00% | |
Maximum number of common stock shares available for purchase per participant (in shares) | 50,000 | |
Purchase plan offering period | 6 months | |
Maximum number of common stock value available for purchase per participant | $ | $ 25,000 | |
Increase in number of shares of common stock available for issuance under the purchase plan (in shares) | 1,000,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 19,839 | $ 17,819 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | 14,642 | 13,127 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 5,197 | $ 4,692 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Granted Using Black-Scholes Option Pricing Model (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected option life (in years) | 5 years 6 months 25 days | 5 years 5 months 15 days |
Risk-free interest rate, Minimum | 0.56% | 0.34% |
Risk-free interest rate, Maximum | 1.32% | 1.61% |
Volatility, Minimum | 80.00% | 74.50% |
Volatility, Maximum | 82.70% | 81.40% |
Dividend yield | 0.00% | 0.00% |
Weighted-average grant-date fair value per stock option (in dollars per share) | $ 1.78 | $ 1.63 |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected option life (in years) | 10 years | 10 years |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Shares | ||
Outstanding, beginning (in shares) | 7,656,623 | 6,439,936 |
Granted (in shares) | 2,397,684 | 2,032,000 |
Exercised (in shares) | (1,250) | (3,542) |
Forfeited (in shares) | (34,565) | (170,187) |
Expired (in shares) | (513,031) | (641,584) |
Outstanding, ending (in shares) | 9,505,461 | 7,656,623 |
Vested (exercisable) (in shares) | 6,371,266 | |
Unvested (unexercisable) (in shares) | 3,134,195 | |
Weighted- Average Exercise Price/Share | ||
Outstanding, beginning (in dollars per share) | $ 7.80 | $ 9.61 |
Granted (in dollars per share) | 2.66 | 2.34 |
Exercised (in dollars per share) | 3.04 | 3.70 |
Forfeited (in dollars per share) | 10.05 | 8.29 |
Expired (in dollars per share) | 9.29 | 8.55 |
Outstanding, ending (in dollars per share) | 6.42 | $ 7.80 |
Vested (exercisable) (in dollars per share) | 8.04 | |
Unvested (unexercisable) (in dollars per share) | $ 3.13 | |
Weighted-Average Remaining Contractual Term (in years), outstanding | 5 years 10 months 9 days | |
Weighted-Average Remaining Contractual Term (in years), vested (exercisable) | 4 years 3 months 3 days | |
Weighted-Average Remaining Contractual Term (in years), unvested (unexercisable) | 9 years 1 month 6 days | |
Exercised, Aggregate Intrinsic Value | $ 1,500 | $ 708,000 |
Aggregate Intrinsic Value, outstanding (exercisable) | 0 | |
Aggregate Intrinsic Value, vested (exercisable) | 0 | |
Aggregate Intrinsic Value, unvested (unexercisable) | $ 0 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Grants (Details) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Granted Stock Options Outstanding (in shares) | shares | 9,505,461 |
Weighted- Average Remaining Contractual Life (in years) | 5 years 10 months 9 days |
Weighted-Average Exercise Price (in dollars per share) | $ 6.42 |
Granted Stock Options Exercisable (in shares) | shares | 6,371,266 |
Weighted-Average Exercise Price (in dollars per share) | $ 8.04 |
$1.29 - 4.96 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 1.29 |
Exercise price, range upper limit (in dollars per share) | $ 4.96 |
Granted Stock Options Outstanding (in shares) | shares | 4,397,491 |
Weighted- Average Remaining Contractual Life (in years) | 7 years 7 months 6 days |
Weighted-Average Exercise Price (in dollars per share) | $ 2.52 |
Granted Stock Options Exercisable (in shares) | shares | 1,507,886 |
Weighted-Average Exercise Price (in dollars per share) | $ 2.58 |
$4.97 - 6.91 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 4.97 |
Exercise price, range upper limit (in dollars per share) | $ 6.91 |
Granted Stock Options Outstanding (in shares) | shares | 1,854,119 |
Weighted- Average Remaining Contractual Life (in years) | 4 years 3 months 29 days |
Weighted-Average Exercise Price (in dollars per share) | $ 6 |
Granted Stock Options Exercisable (in shares) | shares | 1,854,119 |
Weighted-Average Exercise Price (in dollars per share) | $ 6 |
$6.92 - 9.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 6.92 |
Exercise price, range upper limit (in dollars per share) | $ 9 |
Granted Stock Options Outstanding (in shares) | shares | 1,376,034 |
Weighted- Average Remaining Contractual Life (in years) | 3 years 4 months 28 days |
Weighted-Average Exercise Price (in dollars per share) | $ 7.80 |
Granted Stock Options Exercisable (in shares) | shares | 1,300,617 |
Weighted-Average Exercise Price (in dollars per share) | $ 7.77 |
$9.01 - 12.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 9.01 |
Exercise price, range upper limit (in dollars per share) | $ 12 |
Granted Stock Options Outstanding (in shares) | shares | 925,709 |
Weighted- Average Remaining Contractual Life (in years) | 4 years 2 months 1 day |
Weighted-Average Exercise Price (in dollars per share) | $ 11.17 |
Granted Stock Options Exercisable (in shares) | shares | 769,707 |
Weighted-Average Exercise Price (in dollars per share) | $ 11.17 |
$12.01 - 22.64 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 12.01 |
Exercise price, range upper limit (in dollars per share) | $ 22.64 |
Granted Stock Options Outstanding (in shares) | shares | 952,108 |
Weighted- Average Remaining Contractual Life (in years) | 5 years 11 months 26 days |
Weighted-Average Exercise Price (in dollars per share) | $ 18.61 |
Granted Stock Options Exercisable (in shares) | shares | 938,937 |
Weighted-Average Exercise Price (in dollars per share) | $ 18.63 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Restricted Stock and Restricted Stock Unit Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Restricted Share Awards | ||
Number of Restricted Stock Awards | ||
Unvested, Beginning Balance (in shares) | 4,496,045 | 1,659,759 |
Granted (in shares) | 2,820,259 | 4,026,518 |
Share issuance upon approved achievement date (in shares) | (2,272,064) | (753,475) |
Forfeited (in shares) | (608,233) | (436,757) |
Unvested, Ending Balance (in shares) | 4,436,007 | 4,496,045 |
Weighted Average Fair Value per Share at Grant Date | ||
Beginning Balance (in dollars per share) | $ 4.29 | $ 11.67 |
Granted (in dollars per share) | 3.33 | 2.68 |
Share issuance upon approved achievement date (in dollars per share) | 5.06 | 11.23 |
Forfeited (in dollars per share) | 3.85 | 6.03 |
Ending Balance (in dollars per share) | $ 3.33 | $ 4.29 |
Restricted Stock Units | ||
Number of Restricted Stock Awards | ||
Unvested, Beginning Balance (in shares) | 263,524 | 385,919 |
Granted (in shares) | 2,125 | 6,800 |
Market-based achievement adjustment at vesting (in shares) | 75,000 | (128,334) |
Share issuance upon approved achievement date (in shares) | (151,386) | (861) |
Forfeited (in shares) | (4,751) | |
Unvested, Ending Balance (in shares) | 184,512 | 263,524 |
Weighted Average Fair Value per Share at Grant Date | ||
Beginning Balance (in dollars per share) | $ 26.39 | $ 18 |
Granted (in dollars per share) | 3.61 | 2.36 |
Market-based achievement adjustment at vesting (in dollars per share) | 0 | 0 |
Share issuance upon approved achievement date (in dollars per share) | 28.09 | 10.69 |
Forfeited (in dollars per share) | 4.03 | |
Ending Balance (in dollars per share) | $ 23.53 | $ 26.39 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | Jul. 21, 2021 | Nov. 06, 2020 | Aug. 03, 2020 | Aug. 03, 2020 | Jul. 30, 2020 | Apr. 05, 2019 | Jan. 31, 2022 | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2018 | May 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of common shares authorized (in shares) | 300,000,000 | 300,000,000 | 300,000,000 | 175,000,000 | ||||||||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | ||||||||||
Granted (in shares) | 2,397,684 | 2,032,000 | ||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||||
Shares sold in public offering (in shares) | 24,916,667 | |||||||||||
Net proceeds | $ 69,700,000 | |||||||||||
Underwriting discounts and offering expenses | $ 5,000,000 | |||||||||||
Tom Riga | Subsequent Event | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Granted (in shares) | 1,078,500 | |||||||||||
Public Offering | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Shares sold in public offering (in shares) | 21,666,667 | |||||||||||
Shares sold in public offering (in dollars per share) | $ 3 | |||||||||||
Net proceeds | $ 61,100,000 | |||||||||||
Over-Allotment Option | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Shares sold in public offering (in shares) | 3,250,000 | 3,250,000 | ||||||||||
Shares sold in public offering (in dollars per share) | $ 3 | $ 3 | ||||||||||
Net proceeds | $ 9,200,000 | |||||||||||
April 2019 ATM Agreement | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Maximum proceeds to be raised | $ 60,000,000 | $ 150,000,000 | $ 75,000,000 | |||||||||
Registration Statement, July 2021 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Maximum proceeds to be raised | $ 300,000,000 | |||||||||||
Registration Statement, July 2021 | Common Stock | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Maximum proceeds to be raised | $ 150,000,000 | |||||||||||
Stock options | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Shares of common stock issuable upon conversion or exercise of rights granted (in shares) | 6,400,000 | |||||||||||
Stock options | Subsequent Event | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Vesting percent | 33.333% | |||||||||||
Restricted Stock Units | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Granted (in shares) | 2,125 | 6,800 | ||||||||||
Shares of common stock issuable upon conversion or exercise of rights granted (in shares) | 400,000 | |||||||||||
Restricted Stock Units | Subsequent Event | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Vesting percent | 33.333% | |||||||||||
Restricted Stock Units | Tom Riga | Subsequent Event | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Granted (in shares) | 239,500 |
Stockholders' Equity - Sales Ag
Stockholders' Equity - Sales Agreement (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Equity [Abstract] | ||
Stock issued (in shares) | 15,851,391 | 3,950,398 |
Proceeds Received (Net of Broker Commissions and Fees ) | $ 52,621 | $ 14,902 |
Financial Commitments & Conti_3
Financial Commitments & Contingencies and Key License Agreements - Additional Information (Details) | Jan. 01, 2022USD ($) | Aug. 31, 2021plaintiff | May 28, 2021patent | Dec. 31, 2020USD ($) | Apr. 30, 2018USD ($) | Dec. 31, 2021USD ($)licensor | Dec. 31, 2020USD ($) |
Long-term Purchase Commitment [Line Items] | |||||||
Right-of-use assets in exchange for lease liabilities | $ 1,800,000 | $ 0 | |||||
Facility and equipment under lease | $ 2,247,000 | $ 2,505,000 | 2,247,000 | ||||
Licensors | licensor | 2 | ||||||
Deferred compensation liability, current and noncurrent | 9,800,000 | $ 11,200,000 | 9,800,000 | ||||
Bioverativ Therapeutics Inc., Subject Patents | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Patents allegedly infringed | patent | 3 | ||||||
Therapyx | In-License Agreement with Therapyx | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Asset purchase agreement, upfront payment | 800,000 | ||||||
Potential payments based on worldwide annual net sales | 167,500,000 | ||||||
Therapyx | In-License Agreement with Therapyx | Acceptance of certain transferred materials | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Potential payments based on additional achievements of regulatory milestones | 2,200,000 | ||||||
Therapyx | In-License Agreement with Therapyx | First approved IL-12 product | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Potential payments based on additional achievements of regulatory milestones | 30,000,000 | ||||||
Therapyx | In-License Agreement with Therapyx | Each new indication approved for each product in the U.S., Europe, or Japan | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Potential payments based on additional achievements of regulatory milestones | 2,500,000 | ||||||
Hanmi | Eflapegrastim: Co-Development and Commercialization Agreement with Hanmi | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Potential payments based on additional achievements of regulatory milestones | $ 10,000,000 | ||||||
Hanmi | Poziotinib: In-License Agreement with Hanmi and Exclusive Patent and Technology License Agreement with MD Anderson | Subsequent Event | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Achievement of regulatory milestones potential payments | $ 18,000,000 | ||||||
Supplemental royalty milestone limit | $ 15,000,000 | ||||||
MD Anderson | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Achievement of regulatory milestones potential payments | 6,000,000 | ||||||
Payment of upfront fee | 500,000 | ||||||
Potential payments based on achievement of sales milestones | $ 24,000,000 | ||||||
Plaintiffs, Individuals | Shareholder Litigation | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Number of plaintiffs | plaintiff | 4 | ||||||
Plaintiff, Entity | Shareholder Litigation | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Number of plaintiffs | plaintiff | 1 | ||||||
Office and research facilities | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Facility and equipment under lease | 1,900,000 | 2,100,000 | 1,900,000 | ||||
Office equipment | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Facility and equipment under lease | $ 300,000 | $ 400,000 | $ 300,000 | ||||
Minimum | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Remaining term | 1 year | ||||||
Maximum | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Remaining term | 5 years |
Financial Commitments & Conti_4
Financial Commitments & Contingencies and Key License Agreements - Operating Lease Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Operating lease right-of-use assets - non-current | $ 2,505 | $ 2,247 |
Operating lease liabilities - current | 1,282 | 1,544 |
Operating lease liabilities - non-current | 1,452 | 883 |
Total operating lease liabilities | $ 2,734 | $ 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 |
Office and research facilities | ||
Property, Plant and Equipment [Line Items] | ||
Operating lease right-of-use assets - non-current | $ 2,100 | $ 1,900 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Operating lease right-of-use assets - non-current | $ 400 | $ 300 |
Financial Commitments & Conti_5
Financial Commitments & Contingencies and Key License Agreements - Components of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 1,711 | $ 1,865 |
Variable lease cost | 378 | 411 |
Short-term lease cost | 63 | 61 |
Total lease cost | $ 2,152 | $ 2,337 |
Financial Commitments & Conti_6
Financial Commitments & Contingencies and Key License Agreements - Summary of Operating Lease Term and Discount Rate (Details) | Dec. 31, 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 | 3.80% | 7.80% |
Financial Commitments & Conti_7
Financial Commitments & Contingencies and Key License Agreements - Operating Lease Minimum Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
2022 | $ 1,344 | |
2023 | 657 | |
2024 | 669 | |
2025 | 98 | |
2026 | 73 | |
Total future lease payments, undiscounted | 2,841 | |
(Less): Implied interest | (107) | |
Present value of operating lease payments | $ 2,734 | $ 2,427 |
Income Taxes - Components of (L
Income Taxes - Components of (Loss) Income before (Provision) Benefit for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (158,552) | $ (173,398) |
Foreign | 120 | 2,066 |
Loss from continuing operations before income taxes | $ (158,432) | $ (171,332) |
Income Taxes - Provision (Benef
Income Taxes - Provision (Benefit) for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | ||
Federal | $ 0 | $ 0 |
State | 0 | (76) |
Foreign | 4 | 16 |
Current, total | 4 | (60) |
Deferred: | ||
Federal | 0 | 0 |
State | 0 | 0 |
Deferred, total | 0 | 0 |
Total income tax expense (benefit) | $ 4 | $ (60) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes [Line Items] | ||
Foreign | $ 4 | $ 16 |
Valuation allowance | (242,590) | (192,513) |
Increase in valuation allowance due to deferred tax assets | 50,100 | 39,500 |
Federal net operating loss carryforwards | 746,600 | |
State net operating loss carryforwards | 545,500 | |
Foreign loss carryforwards | 500 | |
Research and development tax credits | 27,341 | 25,424 |
Unrecognized tax benefits, if recognized, would affect the effective tax rate | 0 | $ 100 |
Federal loss carryforwards expire in the next five years | 93,100 | |
Federal | ||
Income Taxes [Line Items] | ||
Research and development tax credits | 19,000 | |
State | ||
Income Taxes [Line Items] | ||
Research and development tax credits | $ 10,600 |
Income Taxes - Income Tax Provi
Income Taxes - Income Tax Provision (Benefit) Differs from Computed Using Federal Statutory Rate Applied to Income before Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Tax provision computed at the federal statutory rate | $ (33,210) | $ (35,980) |
State tax, net of federal benefit | (11,050) | (5,142) |
Research and development expense tax credits | (1,838) | (2,686) |
Change in uncertain tax benefit reserve | 0 | (27) |
Change in tax credit carryforwards | 0 | 109 |
Officers compensation | 1,988 | 2,497 |
Stock based compensation | 1,234 | 1,619 |
Permanent items and other | (173) | (37) |
Tax differential on foreign earnings | 0 | (1) |
Change in tax rate | (6,671) | (1,091) |
Change in prior year deferred taxes | (353) | (998) |
Valuation allowance | 50,077 | 41,677 |
Total income tax expense (benefit) | $ 4 | $ (60) |
Income Taxes - Components of Co
Income Taxes - Components of Company's Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 187,129 | $ 143,045 |
Research and development expense tax credits | 27,341 | 25,424 |
Stock based compensation | 5,470 | 4,037 |
Lease obligation | 783 | 599 |
Development costs | 286 | 487 |
Returns and allowances | 1,198 | 1,061 |
Amortization differences | 1,749 | 1,479 |
Depreciation | 57 | 4,746 |
Other, net | 20,267 | 17,420 |
Total deferred tax assets before valuation allowance | 244,280 | 198,298 |
Valuation allowance | (242,590) | (192,513) |
Total deferred tax assets | 1,690 | 5,785 |
Deferred tax liabilities, net: | ||
Unrealized gains | (973) | (5,230) |
Right-of-use asset | (717) | (555) |
Net deferred tax liabilities | $ 0 | $ 0 |
Income Taxes - Summary of Unrec
Income Taxes - Summary of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 3,336 | $ 3,473 |
Adjustments related to prior year tax positions | (318) | (689) |
Increases related to current year tax positions | 506 | 579 |
Decreases due to expiration of tax statutes | 0 | (27) |
Balance at end of year | $ 3,524 | $ 3,336 |
Discontinued Operations - Addit
Discontinued Operations - Additional Information (Details) $ in Thousands | Jul. 03, 2020USD ($) | Mar. 31, 2019USD ($)product | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Error correction amount | $ 6,568 | $ 7,842 | $ 20,523 | |||
Commercial Product Portfolio | Sale | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Number of products | product | 7 | |||||
Upfront payment expected to be received | $ 158,800 | |||||
Aggregate amount receivable based on achievement of milestones | 140,000 | |||||
Payments receivable based on achievement of regulatory milestones | 40,000 | |||||
Potential payments based on achievement of sales milestones | $ 100,000 | |||||
Pricing Of ZEVALIN To Qualifying Public Health Services | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Reduction to government chargebacks liability | $ 10,800 | |||||
Pricing Of ZEVALIN To Qualifying Public Health Services | Revision of Prior Period, Error Correction, Adjustment | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Error correction amount | $ 12,000 |
Discontinued Operations - Conso
Discontinued Operations - Consolidated Statement of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating costs and expenses: | ||
Income (loss) from discontinued operations, net of income taxes | $ (192) | $ 10,404 |
Commercial Product Portfolio | Sale | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Total revenues | 0 | 10,668 |
Operating costs and expenses: | ||
Selling, general and administrative | 0 | 219 |
Research and development | 59 | (43) |
Total operating costs and expenses | 192 | 264 |
Income (loss) from discontinued operations before income taxes | (192) | 10,404 |
Provision for income taxes from discontinued operations | 0 | 0 |
Income (loss) from discontinued operations, net of income taxes | (192) | 10,404 |
Commercial Product Portfolio | Sale | Product sales, net | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Total revenues | 0 | 10,668 |
Operating costs and expenses: | ||
Cost of sales (excluding amortization of intangible assets) | $ 133 | $ 88 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Millions | Aug. 03, 2020 | Jan. 31, 2022 |
Subsequent Event [Line Items] | ||
Number of shares issued in transaction (in shares) | 24,916,667 | |
Subsequent Event | Amendments to licensing agreements for eflapegrastim and poziotinib | ||
Subsequent Event [Line Items] | ||
Release from prior purchase obligation | $ 11.2 | |
Subsequent Event | Hanmi | ||
Subsequent Event [Line Items] | ||
Number of shares issued in transaction (in shares) | 12,500,000 | |
Shares sold in public offering (in dollars per share) | $ 1.60 | |
Equity financing received | $ 20 |