Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2022 | May 09, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-35006 | |
Entity Registrant Name | SPECTRUM PHARMACEUTICALS INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 93-0979187 | |
Entity Address, Address Line One | 11500 South Eastern Avenue | |
Entity Address, Address Line Two | Suite 220 | |
Entity Address, City or Town | Henderson | |
Entity Address, State or Province | NV | |
Entity Address, Postal Zip Code | 89052 | |
City Area Code | 702 | |
Local Phone Number | 835-6300 | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Trading Symbol | SPPI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 180,087,219 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0000831547 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 78,679 | $ 88,539 |
Marketable securities | 10,535 | 12,108 |
Other receivables | 639 | 1,028 |
Prepaid expenses and other current assets | 3,328 | 2,277 |
Total current assets | 93,181 | 103,952 |
Property and equipment, net | 418 | 455 |
Facility and equipment under lease | 2,107 | 2,505 |
Other assets | 4,348 | 4,636 |
Total assets | 100,054 | 111,548 |
Current liabilities: | ||
Accounts payable and other accrued liabilities | 32,575 | 41,258 |
Accrued payroll and benefits | 6,633 | 11,971 |
Total current liabilities | 39,208 | 53,229 |
Other long-term liabilities | 5,590 | 10,766 |
Total liabilities | 44,798 | 63,995 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value; 300,000,000 shares authorized; 178,827,485 and 164,502,013 issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 179 | 165 |
Additional paid-in capital | 1,117,350 | 1,094,353 |
Accumulated other comprehensive loss | (2,908) | (3,042) |
Accumulated deficit | (1,059,365) | (1,043,923) |
Total stockholders’ equity | 55,256 | 47,553 |
Total liabilities and stockholders’ equity | $ 100,054 | $ 111,548 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
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) | 178,827,485 | 164,502,013 |
Common stock, shares outstanding (in shares) | 178,827,485 | 164,502,013 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating costs and expenses: | ||
Selling, general and administrative | $ 9,870 | $ 14,315 |
Research and development | 4,193 | 19,371 |
Total operating costs and expenses | 14,063 | 33,686 |
Loss from continuing operations before other income (expense) and income taxes | (14,063) | (33,686) |
Other income (expense): | ||
Interest income, net | 11 | 84 |
Other expense, net | (1,334) | (2,081) |
Total other expense | (1,323) | (1,997) |
Loss from continuing operations before income taxes | (15,386) | (35,683) |
Benefit for income taxes from continuing operations | (16) | 7 |
Loss from continuing operations | (15,402) | (35,676) |
Loss from discontinued operations, net of income taxes | (40) | (21) |
Net loss | $ (15,442) | $ (35,697) |
Basic and diluted loss per share: | ||
Loss from continuing operations, basic (in dollars per shares) | $ (0.09) | $ (0.25) |
Loss from continuing operations, diluted (in dollars per shares) | (0.09) | (0.25) |
Loss from discontinued operations, basic (in dollars per shares) | 0 | 0 |
Loss from discontinued operations, diluted (in dollars per shares) | 0 | 0 |
Net loss per share, basic (in dollars per shares) | (0.09) | (0.25) |
Net loss per share, diluted (in dollars per shares) | $ (0.09) | $ (0.25) |
Weighted average shares outstanding, basic (in shares) | 169,735,019 | 145,371,657 |
Weighted average shares outstanding, diluted (in shares) | 169,735,019 | 145,371,657 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (15,442) | $ (35,697) |
Other comprehensive income (loss): | ||
Unrealized loss on available-for-sale securities, net of tax | 0 | (1,118) |
Foreign currency translation adjustments | 134 | (560) |
Other comprehensive income (loss) | 134 | (1,678) |
Total comprehensive loss | $ (15,308) | $ (37,375) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2020 | 146,083,110 | ||||
Beginning Balance at Dec. 31, 2020 | $ 134,243 | $ 146 | $ 1,021,221 | $ (1,829) | $ (885,295) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (35,697) | (35,697) | |||
Other comprehensive income, net | (1,678) | (1,678) | |||
Recognition of stock-based compensation expense | 4,212 | 4,212 | |||
Restricted stock award grants, net of forfeitures (in shares) | 1,966,333 | ||||
Restricted stock award grants, net of forfeitures | 2 | $ 2 | |||
Issuance of common shares (in shares) | 5,678,893 | ||||
Issuance of common shares | 21,357 | $ 6 | 21,351 | ||
Ending Balance (in shares) at Mar. 31, 2021 | 153,728,336 | ||||
Ending Balance at Mar. 31, 2021 | 122,439 | $ 154 | 1,046,784 | (3,507) | (920,992) |
Beginning Balance (in shares) at Dec. 31, 2020 | 146,083,110 | ||||
Beginning Balance at Dec. 31, 2020 | 134,243 | $ 146 | 1,021,221 | (1,829) | (885,295) |
Ending Balance (in shares) at Dec. 31, 2021 | 164,502,013 | ||||
Ending Balance at Dec. 31, 2021 | 47,553 | $ 165 | 1,094,353 | (3,042) | (1,043,923) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (15,442) | (15,442) | |||
Other comprehensive income, net | 134 | 134 | |||
Recognition of stock-based compensation expense | 3,011 | 3,011 | |||
Restricted stock award grants, net of forfeitures (in shares) | 1,675,472 | ||||
Restricted stock award grants, net of forfeitures | 0 | $ 2 | (2) | ||
Issuance of common shares (in shares) | 12,500,000 | ||||
Issuance of common shares | 20,000 | $ 12 | 19,988 | ||
Issuance of common stock upon vesting of performance units (in shares) | 150,000 | ||||
Ending Balance (in shares) at Mar. 31, 2022 | 178,827,485 | ||||
Ending Balance at Mar. 31, 2022 | $ 55,256 | $ 179 | $ 1,117,350 | $ (2,908) | $ (1,059,365) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash Flows From Operating Activities: | ||
Loss from continuing operations | $ (15,402) | $ (35,676) |
Loss from discontinued operations, net of income taxes | (40) | (21) |
Net loss | (15,442) | (35,697) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 73 | 65 |
Stock-based compensation | 3,011 | 4,212 |
Non-cash lease expense | 358 | 401 |
Other non-cash items | 462 | 68 |
Loss on disposal of assets | 3 | 0 |
Realized gain on sale of equity holdings | (645) | (2,856) |
Unrealized loss on equity holdings | 1,538 | 4,999 |
Changes in operating assets and liabilities: | ||
Other receivables | 387 | (324) |
Prepaid expenses and other current assets | (1,051) | 670 |
Other assets | 288 | (36) |
Accounts payable and other accrued liabilities | (9,944) | (1,681) |
Accrued payroll and benefits | (5,338) | (4,408) |
Other long-term liabilities | (3,996) | 96 |
Net cash used in operating activities | (30,296) | (34,491) |
Cash Flows From Investing Activities: | ||
Proceeds from maturities of investments | 805 | 49,823 |
Proceeds from sale of equity holdings | 287 | 2,858 |
Purchases of investments | (625) | (15,964) |
Purchases of property and equipment, net | (39) | (73) |
Net cash provided by investing activities | 428 | 36,644 |
Cash Flows From Financing Activities: | ||
Issuance of common shares to Hanmi Pharmaceutical Co., Ltd. | 20,000 | 0 |
Proceeds from sale of common stock under an at-the-market sales agreement, net | 0 | 21,357 |
Net cash provided by financing activities | 20,000 | 21,357 |
Effect of exchange rates on cash and cash equivalents | 8 | 2 |
Net (decrease) increase in cash and cash equivalents | (9,860) | 23,512 |
Cash and cash equivalents—beginning of period | 88,539 | 46,009 |
Cash and cash equivalents—end of period | 78,679 | 69,521 |
Supplemental disclosure of cash flow information: | ||
Cash paid for facility and equipment under operating leases | 584 | 620 |
Cash paid for income taxes | 0 | 4 |
Noncash investing activities: | ||
Additions of property and equipment that remain in accounts payable and other accrued liabilities | $ 0 | $ 27 |
Description of Business, Basis
Description of Business, Basis of Presentation, and Operating Segment | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business, Basis of Presentation, and Operating Segment | Description of Business, Basis of Presentation, And Operating Segment (a) Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharmaceutical company, with a strategy 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. On April 11, 2022, the Company announced that it had received notice that the BLA had been accepted and received a PDUFA date of September 9, 2022; and • 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. Our business strategy is the development of late-stage assets through commercialization and the sourcing of additional assets that are synergistic with our existing portfolio (through purchase acquisitions, in-licensing transactions, or co-development and marketing arrangements). (b) Basis of Presentation Interim Financial Statements The interim financial data for the three months ended March 31, 2022 and 2021 is unaudited and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the three months ended March 31, 2022 and 2021. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. Certain prior period amounts have been reclassified for consistency with the current year presentation. The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included within our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (filed with the SEC on March 17, 2022). Discontinued Operations - Sale of our Commercial Product Portfolio In March 2019, we completed the Commercial Product Portfolio Transaction (see Note 7) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). In accordance with applicable GAAP ( ASC 205-20, Presentation of Financial Statements ), the revenue-deriving activities and allocable expenses of our sold commercial operation, connected to the Commercial Product Portfolio, are separately classified as “discontinued” for all periods presented within the accompanying Consolidated Statements of Operations. Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with GAAP and with the rules and regulations of the SEC. These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. Substantially all of the accumulated other comprehensive loss is comprised of foreign currency translation adjustments at March 31, 2022. Liquidity and Capital Resources The Company expects to incur future net losses as it continues to fund the advancement and commercialization of its product candidates. Based upon our current projections, including our intention to continue to place a disciplined focus on streamlining our business operations, we believe that our $89.2 million in aggregate cash, cash equivalents and marketable securities as of March 31, 2022, will be sufficient to fund our current and planned operations for at least the next twelve months. However, should our costs and expenses prove to be greater than we currently anticipate, or should we change our current business plan in a manner that increases or accelerates our anticipated costs and expenses, we may require additional liquidity earlier than expected. To the extent it becomes necessary to raise additional cash in the future, we will seek to raise it through the public or private sale of debt or equity securities, out-licensing arrangements, funding from joint-venture or strategic partners, debt financing or short-term loans, or a combination of the foregoing. However, we do not currently have any binding commitments for additional financing. Accordingly, we cannot provide any assurance that we will be able to obtain this additional liquidity on terms favorable to us or our current stockholders, or at all. Our liquidity and our ability to fund our capital requirements going forward are dependent, in part, on market and economic factors that are beyond our control. The Company may never achieve profitability or generate positive cash flows, and unless and until it does, the Company will continue to need to raise additional capital. (c) Operating Segment |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Use of Estimates | Summary of Significant Accounting Policies And Use of Estimates The preparation of financial statements in conformity with GAAP requires our management to make informed estimates and assumptions that affect our reported amounts of assets, liabilities, revenues, and expenses. These amounts may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. On an on-going basis, our management evaluates (as applicable) its most critical estimates and assumptions, including those related to: (i) the realization of our tax assets and estimates of our tax liabilities; (ii) the fair value of our investments; (iii) the valuation of our stock options and the periodic expense recognition of stock-based compensation; and (iv) the potential outcome of our ongoing or threatened litigation. Our accounting policies and estimates that most significantly impact the presented amounts within these Condensed Consolidated Financial Statements are further described below: (i) 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 Condensed Consolidated Statements of Operations. Debt securities and bank CDs are classified as “available-for-sale” investments and (1) realized gains (losses) are recognized in “other income (expense), net” within the Condensed Consolidated Statements of Operations and (2) unrealized gains (losses) are recognized as a component of “accumulated other comprehensive loss” within the Condensed Consolidated Statements of Stockholders’ Equity. (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. (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 11.5 million shares and 12.6 million shares of outstanding securities (including stock options, restricted stock units, stock appreciation rights, and performance awards) as of March 31, 2022 and 2021, 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 Condensed 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 | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The table below summarizes certain asset and liability fair values that are included within our accompanying Condensed Consolidated Balance Sheets, and their designations among the three fair value measurement categories: March 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 56,326 $ — $ — $ 56,326 Equity securities 4,655 — — 4,655 Mutual funds 5,880 9 — 5,889 Key employee life insurance, cash surrender value (1) — 4,219 — 4,219 $ 66,861 $ 4,228 $ — $ 71,089 Liabilities: Deferred executive compensation liability (2) $ — $ 10,500 $ — $ 10,500 $ — $ 10,500 $ — $ 10,500 (1) Included within other assets on our Condensed Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $6.3 million within accounts payable and other accrued liabilities and $4.2 million within other long-term liabilities on our Condensed Consolidated Balance Sheets. December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Equity securities $ 5,718 $ — $ — $ 5,718 Money market funds 66,322 — — 66,322 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 Condensed Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $2.0 million within accounts payable and other accrued liabilities and $9.2 million within other long-term liabilities on our Condensed Consolidated Balance Sheets. 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 | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Account Detail | Balance Sheet Account Detail The composition of selected financial statement captions that comprise the accompanying Condensed Consolidated Balance Sheets are summarized below: (a) Cash and Cash Equivalents and Marketable Securities We maintain cash balances with select major financial institutions. The Federal Deposit Insurance Corporation (FDIC) and other third parties insure a fraction of these deposits. Accordingly, these cash deposits are not insured against the possibility of a substantial or complete loss of principal and are inherently subject to the credit risk of the corresponding financial institution. 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 March 31, 2022 or December 31, 2021. The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Fair Cash and Cash Marketable March 31, 2022 Money market funds $ 56,326 $ 56,326 $ 56,326 $ — Equity securities (1) 3,508 4,655 — 4,655 Mutual funds 5,400 5,880 — 5,880 Bank deposits 22,353 22,353 22,353 — Total cash and cash equivalents and marketable securities $ 87,587 $ 89,214 $ 78,679 $ 10,535 December 31, 2021 Equity securities (1) $ 3,512 $ 5,718 $ — $ 5,718 Money market funds 66,322 66,322 66,322 — Bank deposits 22,217 22,217 22,217 — Mutual funds 5,218 6,390 — 6,390 Total cash and cash equivalents and marketable securities $ 97,269 $ 100,647 $ 88,539 $ 12,108 (1) Our aggregate equity holdings consist of 4.7 million common shares of CASI Pharmaceuticals, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $3.8 million as of March 31, 2022. We completed the sale of 0.4 million shares of common stock and recognized a $0.3 million gain within “other expense, net” within the accompanying Condensed Consolidated Statements of Operations for the three months ended March 31, 2022. Additionally, we hold 0.7 million common shares of Unicycive Therapeutics, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $0.9 million as of March 31, 2022. We completed the sale of 0.2 million shares of common stock and recognized a $0.2 million gain within “other expense, net” within the accompanying Condensed Consolidated Statements of Operations for the three months ended March 31, 2022. (b) Accounts Payable and Other Accrued Liabilities “Accounts payable and other accrued liabilities” consists of the following : March 31, 2022 December 31, 2021 Trade accounts payable and other $ 25,305 $ 33,408 Lease liability - current portion 1,001 1,282 Commercial Product Portfolio accruals (Note 7) 6,269 6,568 Accounts payable and other accrued liabilities $ 32,575 $ 41,258 Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed 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, Data, Inventory and Product Return Allowances Total 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 (Less): Payments and credits against GTN accruals (35) — (264) (299) Balance as of March 31, 2022 $ 1,407 $ 942 $ 3,920 $ 6,269 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation In June 2018, we adopted the 2018 Long-Term Incentive Plan, the 2018 Long-Term Incentive Plan (the “2018 Plan”) which provided for the issuance of restricted stock awards and units, incentive and nonqualified stock options, performance unit awards, stock appreciation rights, and other stock-based awards to employees, consultants and members of our Board of Directors. We report our stock-based compensation expense (inclusive of our incentive stock plan and employee stock purchase plan) in the accompanying Condensed Consolidated Statements of Operations within “total operating costs and expenses” for the three months ended March 31, 2022 and 2021, as follows: Three Months Ended 2022 2021 Selling, general and administrative $ 1,915 $ 2,798 Research and development 1,096 1,414 Total stock-based compensation $ 3,011 $ 4,212 Restricted Stock Awards and Restricted Stock Units Stock-based award grants to employees 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. 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. No restricted stock units were granted during the three months ended March 31, 2022. We granted 2.1 million restricted stock awards with a weighted average grant date fair value of $1.20 during the three months ended March 31, 2022. At March 31, 2022 we had 5.1 million restricted stock awards outstanding with a weighted average grant date fair value of $2.39. As of March 31, 2022, there was approximately $10.1 million of unrecognized compensation expense related to the unvested portions of restricted stock awards and restricted stock units. This expense is expected to be recognized over a weighted-average period of approximately 2.1 years. Stock Options Stock option grants to employees, consultants, and members of our Board of Directors generally should be exercised no later than 10 years from the date of grant. We granted 0.02 million stock options with a weighted average exercise price of $1.35 during the three months ended March 31, 2022. At March 31, 2022 we had 8.0 million options outstanding with a weighted average exercise price of $6.07. As of March 31, 2022, there was approximately $3.2 million of unrecognized compensation expense related to unvested stock options. This expense is expected to be recognized over a weighted-average period of approximately 2.0 years. |
Financial Commitments and Conti
Financial Commitments and Contingencies and Key License Agreements | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Financial Commitments and Contingencies and Key License Agreements | Financial Commitments and Contingencies and Key License Agreements (a) Facility and Equipment Leases Overview In the ordinary course of our business, we enter into leases with unaffiliated parties for the use of (i) office and research facilities and (ii) office equipment. Our current leases have remaining terms ranging from less than one year to four years and none include any residual value guarantees, restrictive covenants, term extensions, or early-termination options. We lease our principal executive office in Henderson, Nevada under a non-cancelable operating lease expiring 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 also lease an office facility in Boston under a non-cancelable operating lease expiring 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 March 31, 2022 and 2021, we had no sublease arrangements with us as lessor, and no finance leases, as defined in ASU 2016-02, Leases (“Topic 842”). The reported asset and liability, respectively, represents (i) the economic benefit of our use of leased facilities and equipment and (ii) the present-value of our contractual minimum lease payments, applying our estimated incremental borrowing rate as of the lease commencement date (since an implicit interest rate is not readily determinable in any of our leases). The recorded asset and liability associated with each lease is amortized over the respective lease term using the effective interest rate method. During the three months ended March 31, 2022 and 2021, we recognized no additional ROU 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 Condensed Consolidated Balance Sheets: Operating Leases Condensed Consolidated Balance Sheet Caption March 31, 2022 December 31, 2021 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 2,107 $ 2,505 Operating lease liabilities - current Accounts payable and other accrued liabilities 1,001 1,282 Operating lease liabilities - non-current Other long-term liabilities 1,296 1,452 Total operating lease liabilities $ 2,297 $ 2,734 As of March 31, 2022 and December 31, 2021, our “facility and equipment under lease” consisted of office and research facilities of $1.7 million and $2.1 million, respectively, and office equipment of $0.4 million and $0.4 million, respectively. Components of Lease Expense We recognize lease expense on a straight-line basis over the term of our operating leases, as reported within “selling, general and administrative” expense on the accompanying Condensed Consolidated Statements of Operations. The components of our aggregate lease expense is summarized below: Three Months Ended 2022 2021 Operating lease cost $ 421 $ 466 Variable lease cost 99 125 Short-term lease cost 25 17 Total lease cost $ 545 $ 608 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of March 31, 2022 2.7 years 3.4% Operating leases as of December 31, 2021 2.7 years 3.8% 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 March 31, 2022 2022 (remaining) $ 883 2023 657 2024 669 2025 98 2026 and thereafter 73 Total future lease payments, undiscounted $ 2,380 (Less): Implied interest (83) Present value of operating lease payments $ 2,297 (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. Hanmi has agreed to release the Company from a prior purchase obligation for eflapegrastim drug substance which resulted in a reduction in accrued liabilities of $11.2 million with a corresponding reduction in research and development expense. In addition, beginning in year three after the commercial launch, 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 three months ended March 31, 2022. (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 three months ended March 31, 2022. 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 three months ended March 31, 2022. 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 $2.6 million and $3.1 million for all contractual amounts due and unpaid to Mr. Turgeon as of March 31, 2022 and December 31, 2021, respectively, 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 March 31, 2022 and December 31, 2021, the aggregate value of this DC Plan liability was $10.5 million and $11.2 million, respectively, and is included within “accounts payable and other accrued liabilities” and “other long-term liabilities” in the accompanying Condensed Consolidated Balance Sheets. (g) Litigation We are involved from time-to-time with various legal matters arising in the ordinary course of business. These claims and legal proceedings are of a nature we believe are normal and incidental to a pharmaceutical business, and may include product liability, intellectual property, employment matters, and other general claims. We may also be subject to derivative lawsuits from time to time. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are assessed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. Although the ultimate resolution of these various matters cannot be determined at this time, we do not believe that such matters, individually or in the aggregate, will have a material adverse effect on our consolidated results of operations, cash flows, or financial condition. Bioverativ Patent Litigation On May 28, 2021, Bioverativ Therapeutics Inc. (“Bioverativ”) filed a complaint against us in the U.S. District Court for the District of Delaware, which alleges that our proposed manufacture, use and sale of 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. On March 2, 2022, the Court entered an order partially granting and partially denying without prejudice a stipulated order eliminating defendants’ obligation to answer the initial pleading pending an amended complaint and addressing related briefing scheduling for an anticipated motion to dismiss. We still await the appointment of a lead plaintiff by the Court. Csaba v. Turgeon, et. al, (filed December 15, 2021 , in the U.S. District Court District of Nevada); Shumacher v. Turgeon, et. al, (filed March 15, 2022 in the U.S. District Court District of Nevada); and Johnson v. Turgeon, et. al , (filed March 29, 2022 in the U.S. District Court District of Nevada). These putative stockholder derivative actions were filed against us (as a nominal defendant), 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. The parties are in the process of seeking court approval for the consolidation of the derivative actions and staying the actions until there is an adverse decision on a motion to dismiss in the securities class action. We believe that these claims are without merit and intend to vigorously defend against these claims. |
Discontinued Operations
Discontinued Operations | 3 Months Ended |
Mar. 31, 2022 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | Discontinued Operations Overview In March 2019 we completed the sale of our seven then-commercialized drugs (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 Condensed Consolidated Financial Statements reflect the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations.” Condensed Consolidated Statements of Operations The following table presents the various elements of “ loss from discontinued operations, net of income taxes” as reported in the accompanying Condensed Consolidated Statements of Operations: Three Months Ended 2022 2021 Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) $ 2 $ — Selling, general and administrative — — Research and development 38 21 Total operating costs and expenses 40 21 Loss from discontinued operations before income taxes (40) (21) Provision for income taxes from discontinued operations — — Loss from discontinued operations, net of income taxes $ (40) $ (21) |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Sale of Common Stock Under ATM Agreement On April 5, 2019, we entered into a collective at-the-market-issuance (“ATM”) sales agreement with Cantor Fitzgerald & Co., H.C. Wainwright & Co., LLC and B. Riley FBR, Inc. (the “April 2019 ATM Agreement”), pursuant to which we may offer and sell shares of our common stock by any method deemed to be an “at the market” offering (the “ATM Offering”). From April 5, 2019 to March 2, 2020, the ATM Offering was conducted pursuant to a sales agreement prospectus filed with our automatic shelf registration statement on Form S-3ASR, filed with the SEC on April 5, 2019, which registered an aggregate offering price of $150 million under the April 2019 ATM Agreement. From May 8, 2020 to June 30, 2020, the ATM Offering was conducted pursuant to a sales agreement prospectus (the “Initial Sales Agreement Prospectus”) filed with our shelf registration statement on Form S-3, filed with the SEC on March 20, 2020, as amended by Pre-Effective Amendment No. 1 thereto, and declared effective by the SEC on May 8, 2020 (the “Registration Statement”), which registered an aggregate offering price of up to $75 million under the April 2019 ATM Agreement. On July 29, 2020, we terminated the Initial Sales Agreement Prospectus, but left the April 2019 ATM Agreement in full force and effect. On November 6, 2020, we filed a new sales agreement prospectus to the Registration Statement, which registered an aggregate offering price of up to $60 million under the April 2019 ATM Agreement. On July 13, 2021, we filed a shelf registration statement with the SEC on Form S-3, which was declared effective by the SEC on July 21, 2021 (the “Registration Statement”). The Registration Statement registered an aggregate offering price of up to $300 million of securities that may be issued and sold by us from time to time, including up to an aggregate offering price of $150 million of common stock (which amount is included in the $300 million aggregate offering price set forth in the base prospectus) that may be issued and sold pursuant to the April 2019 ATM Agreement. 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. We sold and issued common shares under the April 2019 ATM Agreement as follows: Period in Which Issued No. of Common Shares Issued Proceeds Received Year ended December 31, 2021 15,851,391 $ 52,621 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsDuring April 2022 and through the date of this filing, we sold and issued 1.4 million shares of our common stock for net proceeds of $1.4 million under the April 2019 ATM Agreement. |
Description of Business, Basi_2
Description of Business, Basis of Presentation, and Operating Segment (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharmaceutical company, with a strategy 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. On April 11, 2022, the Company announced that it had received notice that the BLA had been accepted and received a PDUFA date of September 9, 2022; and • 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. Our business strategy is the development of late-stage assets through commercialization and the sourcing of additional assets that are synergistic with our existing portfolio (through purchase acquisitions, in-licensing transactions, or co-development and marketing arrangements). |
Basis of Presentation | Basis of Presentation Interim Financial Statements The interim financial data for the three months ended March 31, 2022 and 2021 is unaudited and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the three months ended March 31, 2022 and 2021. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. Certain prior period amounts have been reclassified for consistency with the current year presentation. The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included within our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (filed with the SEC on March 17, 2022). Discontinued Operations - Sale of our Commercial Product Portfolio In March 2019, we completed the Commercial Product Portfolio Transaction (see Note 7) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). In accordance with applicable GAAP ( ASC 205-20, Presentation of Financial Statements ), the revenue-deriving activities and allocable expenses of our sold commercial operation, connected to the Commercial Product Portfolio, are separately classified as “discontinued” for all periods presented within the accompanying Consolidated Statements of Operations. Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with GAAP and with the rules and regulations of the SEC. These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. Substantially all of the accumulated other comprehensive loss is comprised of foreign currency translation adjustments at March 31, 2022. 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 three months ended March 31, 2022 and 2021, all of our operating costs and expenses were solely attributable to these activities (and as applicable, classified as “discontinued” within the accompanying Condensed 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. |
Cash and Cash Equivalents | Cash and Cash EquivalentsCash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. |
Marketable Securities | Marketable SecuritiesMarketable securities consist of our holdings in equity securities (including mutual funds), bank CDs, government-related debt securities, and corporate debt securities. For equity securities and mutual funds, any realized gains (losses) or unrealized gains (losses) are recognized in “other income (expense), net” within the Condensed Consolidated Statements of Operations. Debt securities and bank CDs are classified as “available-for-sale” investments and (1) realized gains (losses) are recognized in “other income (expense), net” within the Condensed Consolidated Statements of Operations and (2) unrealized gains (losses) are recognized as a component of “accumulated other comprehensive loss” within the Condensed Consolidated Statements of Stockholders’ Equity. |
Property and Equipment, Net | Property and Equipment, NetOur property and equipment, net, is stated at historical cost, and is depreciated on a straight-line basis over an estimated useful life that corresponds with its designated asset category. We evaluate the recoverability of long-lived assets (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable. Recoverability is measured by a comparison of the carrying amount to the net undiscounted cash flows expected to be generated by the asset group. An impairment loss would be recorded for the excess of net carrying value over the fair value of the asset impaired. The fair value is estimated based on expected discounted future cash flows or other methods such as orderly liquidation value based on assumptions of asset class and observed market data. An orderly liquidation value is the amount that could be realized upon liquidation, given a sufficient amount of time to find a purchaser for a sale of assets in their existing condition and location, as of a specific date, and assuming the sale is to market participants who can utilize such assets in their highest and best use. The orderly liquidation values are applied against the carrying values of the assets and the impairment loss is measured as the difference between the liquidation value and the carrying value of the assets. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for equity awards granted to our employees and members of our Board of Directors is recognized on a straight-line basis over each award’s vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited prior to vesting, though is ultimately adjusted for actual forfeitures. We use the Black-Scholes option pricing model to determine the fair value of stock options and stock appreciation rights (as of the date of grant) that have service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) that have combined market conditions and service conditions for vesting. The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term that the stock option will remain outstanding, (c) our stock price volatility over the expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the prevailing risk-free interest rate for the period matching the expected term. With regard to (a)-(d) above: we estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on the historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option. |
Basic and Diluted Net Loss per Share | Basic and Diluted Net Loss per 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 11.5 million shares and 12.6 million shares of outstanding securities (including stock options, restricted stock units, stock appreciation rights, and performance awards) as of March 31, 2022 and 2021, respectively, that were excluded from the calculation of diluted net loss per share because their inclusion would have been anti-dilutive. |
Income Taxes | Income TaxesDeferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. We apply an estimated annual effective tax rate (“ETR”) approach for calculating a tax provision for interim periods. Our ETR differs from the U.S. federal statutory tax rate primarily as a result of nondeductible expenses and the impact of a valuation allowance on our deferred tax assets, which we record because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income in the period that such determination was made. In the event that we are assessed interest and/or penalties from taxing authorities that have not been previously accrued, such amounts would be included in “benefit for income taxes from continuing operations” within the accompanying Condensed Consolidated Statements of Operations for the period in which we received the notice. |
Research and Development Expenses | Research and Development ExpensesOur research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, benefits, and other staff-related costs including associated stock-based compensation, laboratory supplies, clinical trial and related clinical manufacturing costs, costs related to manufacturing preparations, fees paid to other entities that conduct certain research and development activities on our behalf and payments made pursuant to license agreements. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. We accrue for costs incurred as the services are being provided by monitoring the status of activities and the invoices received from our external service providers. We adjust our accruals as actual costs become known. Where contingent milestone payments are due to third parties under research and development or license agreements, the milestone payment obligations are expensed when the clinical or regulatory milestone results are achieved. |
Fair Value Measurements | Fair Value Measurements We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. |
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. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Asset and Liability Fair Values | The table below summarizes certain asset and liability fair values that are included within our accompanying Condensed Consolidated Balance Sheets, and their designations among the three fair value measurement categories: March 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 56,326 $ — $ — $ 56,326 Equity securities 4,655 — — 4,655 Mutual funds 5,880 9 — 5,889 Key employee life insurance, cash surrender value (1) — 4,219 — 4,219 $ 66,861 $ 4,228 $ — $ 71,089 Liabilities: Deferred executive compensation liability (2) $ — $ 10,500 $ — $ 10,500 $ — $ 10,500 $ — $ 10,500 (1) Included within other assets on our Condensed Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $6.3 million within accounts payable and other accrued liabilities and $4.2 million within other long-term liabilities on our Condensed Consolidated Balance Sheets. December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Equity securities $ 5,718 $ — $ — $ 5,718 Money market funds 66,322 — — 66,322 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 Condensed Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. |
Balance Sheet Account Detail (T
Balance Sheet Account Detail (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 Cash and Cash Marketable March 31, 2022 Money market funds $ 56,326 $ 56,326 $ 56,326 $ — Equity securities (1) 3,508 4,655 — 4,655 Mutual funds 5,400 5,880 — 5,880 Bank deposits 22,353 22,353 22,353 — Total cash and cash equivalents and marketable securities $ 87,587 $ 89,214 $ 78,679 $ 10,535 December 31, 2021 Equity securities (1) $ 3,512 $ 5,718 $ — $ 5,718 Money market funds 66,322 66,322 66,322 — Bank deposits 22,217 22,217 22,217 — Mutual funds 5,218 6,390 — 6,390 Total cash and cash equivalents and marketable securities $ 97,269 $ 100,647 $ 88,539 $ 12,108 (1) Our aggregate equity holdings consist of 4.7 million common shares of CASI Pharmaceuticals, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $3.8 million as of March 31, 2022. We completed the sale of 0.4 million shares of common stock and recognized a $0.3 million gain within “other expense, net” within the accompanying Condensed Consolidated Statements of Operations for the three months ended March 31, 2022. Additionally, we hold 0.7 million common shares of Unicycive Therapeutics, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $0.9 million as of March 31, 2022. We completed the sale of 0.2 million shares of common stock and recognized a $0.2 million gain within “other expense, net” within the accompanying Condensed Consolidated Statements of Operations for the three months ended March 31, 2022. |
Schedule of Accounts Payable and Other Accrued Liabilities | “Accounts payable and other accrued liabilities” consists of the following : March 31, 2022 December 31, 2021 Trade accounts payable and other $ 25,305 $ 33,408 Lease liability - current portion 1,001 1,282 Commercial Product Portfolio accruals (Note 7) 6,269 6,568 Accounts payable and other accrued liabilities $ 32,575 $ 41,258 |
Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities | Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed Consolidated Balance Sheets for our categories of gross-to-net (“GTN”) estimates related to the Commercial Product Portfolio accruals were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, Data, Inventory and Product Return Allowances Total Balance as of December 31, 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 (Less): Payments and credits against GTN accruals (35) — (264) (299) Balance as of March 31, 2022 $ 1,407 $ 942 $ 3,920 $ 6,269 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 Condensed Consolidated Statements of Operations within “total operating costs and expenses” for the three months ended March 31, 2022 and 2021, as follows: Three Months Ended 2022 2021 Selling, general and administrative $ 1,915 $ 2,798 Research and development 1,096 1,414 Total stock-based compensation $ 3,011 $ 4,212 |
Financial Commitments and Con_2
Financial Commitments and Contingencies and Key License Agreements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 Condensed Consolidated Balance Sheets: Operating Leases Condensed Consolidated Balance Sheet Caption March 31, 2022 December 31, 2021 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 2,107 $ 2,505 Operating lease liabilities - current Accounts payable and other accrued liabilities 1,001 1,282 Operating lease liabilities - non-current Other long-term liabilities 1,296 1,452 Total operating lease liabilities $ 2,297 $ 2,734 |
Schedule of Aggregate Lease Expense | The components of our aggregate lease expense is summarized below: Three Months Ended 2022 2021 Operating lease cost $ 421 $ 466 Variable lease cost 99 125 Short-term lease cost 25 17 Total lease cost $ 545 $ 608 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of March 31, 2022 2.7 years 3.4% Operating leases as of December 31, 2021 2.7 years 3.8% |
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 March 31, 2022 2022 (remaining) $ 883 2023 657 2024 669 2025 98 2026 and thereafter 73 Total future lease payments, undiscounted $ 2,380 (Less): Implied interest (83) Present value of operating lease payments $ 2,297 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Condensed Consolidated Statements of Operations and Cash Flows | The following table presents the various elements of “ loss from discontinued operations, net of income taxes” as reported in the accompanying Condensed Consolidated Statements of Operations: Three Months Ended 2022 2021 Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) $ 2 $ — Selling, general and administrative — — Research and development 38 21 Total operating costs and expenses 40 21 Loss from discontinued operations before income taxes (40) (21) Provision for income taxes from discontinued operations — — Loss from discontinued operations, net of income taxes $ (40) $ (21) |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Schedule of Stock by Class | We sold and issued common shares under the April 2019 ATM Agreement as follows: Period in Which Issued No. of Common Shares Issued Proceeds Received Year ended December 31, 2021 15,851,391 $ 52,621 |
Description of Business, Basi_3
Description of Business, Basis of Presentation, and Operating Segment (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022USD ($)productsegment | Dec. 31, 2021USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of late stage development products | product | 2 | |
Cash, cash equivalents and marketable securities | $ | $ 89,214 | $ 100,647 |
Number of reportable operating segment | segment | 1 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Use of Estimates (Details) - shares shares in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Accounting Policies [Abstract] | ||
Anti-dilutive excluded from computation of earnings per share amount (in shares) | 11.5 | 12.6 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Asset and Liability Fair Values (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Assets: | ||
Equity securities | $ 4,655 | $ 5,718 |
Key employee life insurance, cash surrender value | 4,219 | 4,507 |
Total Assets | 71,089 | 82,946 |
Liabilities: | ||
Deferred executive compensation liability | 10,500 | 11,243 |
Total Liabilities | 10,500 | 11,243 |
Money market funds | ||
Assets: | ||
Available-for-sale | 56,326 | 66,322 |
Mutual funds | ||
Assets: | ||
Available-for-sale | 5,889 | 6,399 |
Level 1 | ||
Assets: | ||
Equity securities | 4,655 | 5,718 |
Key employee life insurance, cash surrender value | 0 | 0 |
Total Assets | 66,861 | 78,430 |
Liabilities: | ||
Deferred executive compensation liability | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 1 | Money market funds | ||
Assets: | ||
Available-for-sale | 56,326 | 66,322 |
Level 1 | Mutual funds | ||
Assets: | ||
Available-for-sale | 5,880 | 6,390 |
Level 2 | ||
Assets: | ||
Equity securities | 0 | 0 |
Key employee life insurance, cash surrender value | 4,219 | 4,507 |
Total Assets | 4,228 | 4,516 |
Liabilities: | ||
Deferred executive compensation liability | 10,500 | 11,243 |
Total Liabilities | 10,500 | 11,243 |
Level 2 | Accounts payable and other accrued liabilities | ||
Liabilities: | ||
Deferred executive compensation liability | 6,300 | 2,000 |
Level 2 | Other long-term liabilities | ||
Liabilities: | ||
Deferred executive compensation liability | 4,200 | 9,200 |
Level 2 | Money market funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 2 | Mutual funds | ||
Assets: | ||
Available-for-sale | 9 | 9 |
Level 3 | ||
Assets: | ||
Equity securities | 0 | 0 |
Key employee life insurance, cash surrender value | 0 | 0 |
Total Assets | 0 | 0 |
Liabilities: | ||
Deferred executive compensation liability | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 3 | Money market funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 | Mutual funds | ||
Assets: | ||
Available-for-sale | $ 0 | $ 0 |
Balance Sheet Account Detail -
Balance Sheet Account Detail - Summary of Cash and Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands, shares in Millions | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Schedule of Investments [Line Items] | |||
Equity securities, FV-NI, cost | $ 3,508 | $ 3,512 | |
Cash, cash equivalents, and short-term investments, amortized cost | 87,587 | 97,269 | |
Equity securities | 4,655 | 5,718 | |
Cash, cash equivalents, and short-term investments | 89,214 | 100,647 | |
Realized gain on sale of equity holdings | 645 | $ 2,856 | |
CASI Common Stock | |||
Schedule of Investments [Line Items] | |||
Equity securities | $ 3,800 | ||
Number of shares held in investment (in shares) | 4.7 | ||
Number of common shares sale in investments (in shares) | 0.4 | ||
Realized gain on sale of equity holdings | $ 300 | ||
Unicycive Therapeutics, Inc. | |||
Schedule of Investments [Line Items] | |||
Equity securities | $ 900 | ||
Number of shares held in investment (in shares) | 0.7 | ||
Number of common shares sale in investments (in shares) | 0.2 | ||
Realized gain on sale of equity holdings | $ 200 | ||
Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Equity securities | 0 | 0 | |
Cash, cash equivalents, and short-term investments | 78,679 | 88,539 | |
Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Equity securities | 4,655 | 5,718 | |
Cash, cash equivalents, and short-term investments | 10,535 | 12,108 | |
Money market funds | |||
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | 56,326 | 66,322 | |
Available-for-sale | 56,326 | 66,322 | |
Money market funds | Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 56,326 | 66,322 | |
Money market funds | Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 0 | 0 | |
Mutual funds | |||
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | 5,400 | 5,218 | |
Available-for-sale | 5,880 | 6,390 | |
Mutual funds | Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 0 | 0 | |
Mutual funds | Marketable Securities | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 5,880 | 6,390 | |
Bank deposits | |||
Schedule of Investments [Line Items] | |||
Historical or Amortized Cost | 22,353 | 22,217 | |
Available-for-sale | 22,353 | 22,217 | |
Bank deposits | Cash and Cash Equivalents | |||
Schedule of Investments [Line Items] | |||
Available-for-sale | 22,353 | 22,217 | |
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 Accounts Payable and Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other | $ 25,305 | $ 33,408 |
Lease liability - current portion | 1,001 | 1,282 |
Commercial Product Portfolio accruals (Note 7) | 6,269 | 6,568 |
Accounts payable and other accrued liabilities | $ 32,575 | $ 41,258 |
Balance Sheet Account Detail _3
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | $ 6,568 | $ 7,842 |
(Less): Payments and credits against GTN accruals | (299) | (1,274) |
Ending balance | 6,269 | 6,568 |
Commercial/Medicaid Rebates and Government Chargebacks | ||
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | 1,442 | 2,601 |
(Less): Payments and credits against GTN accruals | (35) | (1,159) |
Ending balance | 1,407 | 1,442 |
Distribution, Data, Inventory and GPO Administrative Fees | ||
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | 942 | 942 |
(Less): Payments and credits against GTN accruals | 0 | 0 |
Ending balance | 942 | 942 |
Product Return Allowances | ||
Accounts Payable and Other Liabilities [Roll Forward] | ||
Beginning balance | 4,184 | 4,299 |
(Less): Payments and credits against GTN accruals | (264) | (115) |
Ending balance | $ 3,920 | $ 4,184 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 3,011 | $ 4,212 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | 1,915 | 2,798 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 1,096 | $ 1,414 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock options granted (in shares) | 20,000 | |
Stock options weighted average exercise price (in dollar per share) | $ 1.35 | |
Stock options outstanding (in shares) | 8,000,000 | |
Stock options outstanding weighted average exercise price (in dollar per share) | $ 6.07 | |
Unrecognized compensation expense related to options | $ 3.2 | |
Restricted Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 3 years | |
Awards granted (in shares) | 2,100,000 | 0 |
Awards weighted average grant date fair value(in dollar per share) | $ 1.20 | |
Awards outstanding (in shares) | 5,100,000 | |
Awards outstanding weighted average grant date fair value (in dollar per shares) | $ 2.39 | |
Unrecognized compensation expense | $ 10.1 | |
Weighted-average period for recognition (in years) | 2 years 1 month 6 days | |
Restricted Stock | Year one | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting percent | 33.333% | |
Restricted Stock | Year two | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting percent | 33.333% | |
Restricted Stock | 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] | ||
Weighted-average period for recognition (in years) | 2 years | |
Expiration period | 10 years |
Financial Commitments and Con_3
Financial Commitments and Contingencies and Key License Agreements - Additional Information (Details) | Jan. 01, 2022USD ($) | Aug. 31, 2021plaintiff | May 28, 2021patent | Dec. 31, 2020USD ($) | Apr. 30, 2019product | Apr. 30, 2018USD ($) | Mar. 31, 2022USD ($) | Dec. 31, 2021USD ($) | Mar. 31, 2021USD ($) |
Long-term Purchase Commitment [Line Items] | |||||||||
Facility and equipment under lease | $ 2,107,000 | $ 2,505,000 | |||||||
Licensors | product | 2 | ||||||||
Accrued payroll and benefits | 6,633,000 | 11,971,000 | |||||||
Deferred compensation liability, current and noncurrent | 10,500,000 | 11,200,000 | |||||||
Bioverativ Therapeutics Inc., Subject Patents | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Patents allegedly infringed | patent | 3 | ||||||||
Hanmi Pharmaceutical Co. Ltd. (“Hanmi”) | Eflapegrastim, Co-Development and Commercialization Agreement | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Reduction in accrued liabilities | $ 11,200,000 | ||||||||
Potential payments based on additional achievements of regulatory milestones | 10,000,000 | ||||||||
Hanmi Pharmaceutical Co. Ltd. (“Hanmi”) | Poziotinib: In-License Agreement | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Achievement of regulatory milestones potential payments | 18,000,000 | ||||||||
Supplemental royalty milestone limit | $ 15,000,000 | ||||||||
Therapyx | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Asset purchase agreement, upfront payment | $ 800,000 | ||||||||
Entity plaintiff | Shareholder Litigation | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Number of plaintiffs | plaintiff | 1 | ||||||||
Plaintiffs, Individual | Shareholder Litigation | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Number of plaintiffs | plaintiff | 4 | ||||||||
MD Anderson | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Payment of upfront fee | $ 500,000 | ||||||||
Chief Executive Officer | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Accrued payroll and benefits | 2,600,000 | $ 3,100,000 | |||||||
Plan | Therapyx | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Potential payments based on additional achievements of regulatory milestones | 2,200,000 | ||||||||
Potential payments based on worldwide annual net sales | 167,500,000 | ||||||||
Plan | Therapyx | I L12 Product | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Potential payments based on additional achievements of regulatory milestones | 30,000,000 | ||||||||
Plan | Therapyx | Each new indication approved | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Potential payments based on additional achievements of regulatory milestones | $ 2,500,000 | ||||||||
Plan | MD Anderson | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Achievement of regulatory milestones potential payments | 6,000,000 | ||||||||
Potential payments based on achievement of sales milestones | $ 24,000,000 | ||||||||
Office and research facilities | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Facility and equipment under lease | 1,700,000 | 2,100,000 | |||||||
Office equipment | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Facility and equipment under lease | $ 400,000 | $ 400,000 | |||||||
Minimum | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Remaining lease term (in years) | 1 year | ||||||||
Maximum | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Remaining lease term (in years) | 4 years |
Financial Commitments and Con_4
Financial Commitments and Contingencies and Key License Agreements - Operating Lease Balance Sheet Information (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
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 |
Operating lease right-of-use assets - non-current | $ 2,107 | $ 2,505 |
Operating lease liabilities - current | 1,001 | 1,282 |
Operating lease liabilities - non-current | 1,296 | 1,452 |
Total operating lease liabilities | $ 2,297 | $ 2,734 |
Financial Commitments and Con_5
Financial Commitments and Contingencies and Key License Agreements - Components of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 421 | $ 466 |
Variable lease cost | 99 | 125 |
Short-term lease cost | 25 | 17 |
Total lease cost | $ 545 | $ 608 |
Financial Commitments and Con_6
Financial Commitments and Contingencies and Key License Agreements - Summary of Operating Lease Term and Discount Rate (Details) | Mar. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted Average Remaining Lease Term | 2 years 8 months 12 days | 2 years 8 months 12 days |
Weighted Average Discount Rate | 3.40% | 3.80% |
Financial Commitments and Con_7
Financial Commitments and Contingencies and Key License Agreements - Contractual Lease Payments (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
2022 (remaining) | $ 883 | |
2023 | 657 | |
2024 | 669 | |
2025 | 98 | |
2026 and thereafter | 73 | |
Total future lease payments, undiscounted | 2,380 | |
(Less): Implied interest | (83) | |
Present value of operating lease payments | $ 2,297 | $ 2,734 |
Discontinued Operations - Addit
Discontinued Operations - Additional Information (Details) - Sale - Commercial Product Portfolio $ in Millions | 1 Months Ended |
Mar. 31, 2019USD ($)product | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |
Number of products | product | 7 |
Consideration | $ 158.8 |
Aggregate amount receivable based on achievement of milestones | 140 |
Payments receivable based on achievement of regulatory milestones | 40 |
Potential payments based on achievement of sales milestones | $ 100 |
Discontinued Operations - Conde
Discontinued Operations - Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating costs and expenses: | ||
Loss from discontinued operations, net of income taxes | $ (40) | $ (21) |
Sale | Commercial Product Portfolio | ||
Operating costs and expenses: | ||
Selling, general and administrative | 0 | 0 |
Research and development | 38 | 21 |
Total operating costs and expenses | 40 | 21 |
Loss from discontinued operations before income taxes | (40) | (21) |
Provision for income taxes from discontinued operations | 0 | 0 |
Loss from discontinued operations, net of income taxes | (40) | (21) |
Sale | Commercial Product Portfolio | Product sales, net | ||
Operating costs and expenses: | ||
Cost of sales (excluding amortization of intangible assets) | $ 2 | $ 0 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | Jul. 21, 2021 | Nov. 06, 2020 | May 08, 2020 | Apr. 05, 2019 | Jan. 31, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Proceeds from sale of common stock under an at-the-market sales agreement, net | $ 0 | $ 21,357,000 | ||||||
April 2019 ATM Agreement | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Maximum proceeds | $ 60,000,000 | $ 75,000,000 | $ 150,000,000 | |||||
Number of Common Shares Issued (in shares) | 15,851,391 | |||||||
Proceeds Received (Net of Broker Commissions and Fees ) | $ 52,621,000 | |||||||
Registration Statement, July 2021 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Maximum proceeds | $ 300,000,000 | |||||||
Registration Statement, July 2021 | Common Stock | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Maximum proceeds | $ 150,000,000 | |||||||
Securities Purchase Agreement | Hanmi Pharmaceutical Co. Ltd. (“Hanmi”) | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares sold in public offering (in shares) | 12,500,000 | |||||||
Shares sold in public offering (in dollars per share) | $ 1.60 | |||||||
Proceeds from sale of common stock under an at-the-market sales agreement, net | $ 20,000,000 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent event - April 2019 ATM Agreement shares in Millions, $ in Millions | 1 Months Ended |
Apr. 30, 2022USD ($)shares | |
Subsequent Event [Line Items] | |
Shares sold in public offering (in shares) | shares | 1.4 |
Net proceeds | $ | $ 1.4 |