Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 24, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-35006 | ||
Entity Registrant Name | SPECTRUM PHARMACEUTICALS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 93-0979187 | ||
Entity Address, Address Line One | 11500 South Eastern Avenue | ||
Entity Address, Address Line Two | Suite 240 | ||
Entity Address, City or Town | Henderson | ||
Entity Address, State or Province | NV | ||
Entity Address, Postal Zip Code | 89052 | ||
City Area Code | 702 | ||
Local Phone Number | 835-6300 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | SPPI | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 246,663,071 | ||
Entity Common Stock, Shares Outstanding | 153,728,336 | ||
Documents Incorporated by Reference | Portions of the registrant’s Proxy Statement for its 2021 Annual Meeting of Stockholders, to be filed on or before April 30, 2021, are incorporated by reference into Part III, Items 10-14 of this Annual Report on Form 10-K. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0000831547 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 46,009 | $ 64,418 |
Marketable securities | 134,016 | 159,455 |
Accounts receivable, net | 67 | 441 |
Other receivables | 2,394 | 9,558 |
Prepaid expenses and other current assets | 4,161 | 10,148 |
Total current assets | 186,647 | 244,020 |
Property and equipment, net | 3,577 | 11,607 |
Facility and equipment under lease | 2,247 | 3,806 |
Other assets | 4,327 | 4,000 |
Total assets | 196,798 | 263,433 |
Current liabilities: | ||
Accounts payable and other accrued liabilities | 43,771 | 54,284 |
Accrued payroll and benefits | 9,375 | 7,686 |
Total current liabilities | 53,146 | 61,970 |
Other long-term liabilities | 9,409 | 11,070 |
Total liabilities | 62,555 | 73,040 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value; 300,000,000 shares authorized; 146,083,110 and 113,299,612 issued and outstanding at December 31, 2020 and 2019, respectively | 146 | 113 |
Additional paid-in capital | 1,021,221 | 918,205 |
Accumulated other comprehensive loss | (1,829) | (3,498) |
Accumulated deficit | (885,295) | (724,427) |
Total stockholders’ equity | 134,243 | 190,393 |
Total liabilities and stockholders’ equity | $ 196,798 | $ 263,433 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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) | 146,083,110 | 113,299,612 |
Common stock, shares outstanding (in shares) | 146,083,110 | 113,299,612 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | ||
Revenues | $ 0 | $ 0 |
Operating costs and expenses: | ||
Selling, general and administrative | 60,357 | 61,373 |
Research and Development Expense | 109,377 | 79,325 |
Total operating costs and expenses | 169,734 | 140,698 |
Loss from continuing operations before other income (expense) and income taxes | (169,734) | (140,698) |
Other income (expense): | ||
Interest income, net | 1,342 | 4,996 |
Other expense, net | (2,940) | (8,892) |
Total other expense | (1,598) | (3,896) |
Loss from continuing operations before income taxes | (171,332) | (144,594) |
Benefit for income taxes from continuing operations | 60 | 9,208 |
Loss from continuing operations | (171,272) | (135,386) |
Income from discontinued operations, net of income taxes | 10,404 | 22,697 |
Net loss | $ (160,868) | $ (112,689) |
Basic and diluted loss per share: | ||
Loss per common share from continuing operations (in dollars per share) | $ (1.38) | $ (1.22) |
Income per common share from discontinued operations (in dollars per share) | 0.08 | 0.21 |
Net loss per common share (in dollars per share) | $ (1.29) | $ (1.02) |
Weighted average shares outstanding, basic and diluted (in shares) | 124,386,545 | 110,585,768 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (160,868) | $ (112,689) |
Other comprehensive income (loss): | ||
Unrealized gain on available-for-sale securities, net of tax | 303 | 622 |
Foreign currency translation adjustments | 1,366 | (418) |
Other comprehensive income | 1,669 | 204 |
Total comprehensive loss | $ (159,199) | $ (112,485) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Public Stock Offering | At-the-market Sales Agreement | Common Stock | Common StockPublic Stock Offering | Common StockAt-the-market Sales Agreement | Additional Paid-In Capital | Additional Paid-In CapitalPublic Stock Offering | Additional Paid-In CapitalAt-the-market Sales Agreement | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance, (in shares) at Dec. 31, 2018 | 110,525,141 | ||||||||||
Beginning Balance at Dec. 31, 2018 | $ 271,410 | $ 110 | $ 886,740 | $ (3,702) | $ (611,738) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (112,689) | (112,689) | |||||||||
Other comprehensive income, net | 204 | 204 | |||||||||
Recognition of stock-based compensation expense | $ 20,416 | 20,416 | |||||||||
Issuance of common stock (in shares) | 221,529 | 221,529 | |||||||||
Issuance of common stock | $ 1,817 | 1,817 | |||||||||
Issuance of common stock to 401(k) plan for employees, (in shares) | 225,780 | ||||||||||
Issuance of common stock to 401(k) plan for employees | 1,422 | 1,422 | |||||||||
Issuance of common stock for employee stock purchase plan (in shares) | 131,966 | ||||||||||
Issuance of common stock for employee stock purchase plan | $ 663 | 663 | |||||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,121,403 | 1,121,403 | |||||||||
Issuance of common stock upon exercise of stock options | $ 7,149 | $ 2 | 7,147 | ||||||||
Restricted stock award grants, net of forfeitures (in shares) | 830,033 | ||||||||||
Restricted stock award grants, net of forfeitures | 1 | $ 1 | |||||||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 243,760 | ||||||||||
Issuance of common stock upon vesting of restricted stock units | $ 0 | ||||||||||
Ending Balance, (in shares) at Dec. 31, 2019 | 113,299,612 | 113,299,612 | |||||||||
Ending Balance at Dec. 31, 2019 | $ 190,393 | $ 113 | 918,205 | (3,498) | (724,427) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (160,868) | (160,868) | |||||||||
Other comprehensive income, net | 1,669 | 1,669 | |||||||||
Recognition of stock-based compensation expense | $ 17,554 | 17,554 | |||||||||
Issuance of common stock (in shares) | 3,950,398 | 24,916,667 | 3,950,398 | ||||||||
Issuance of common stock | $ 69,665 | $ 14,902 | $ 25 | $ 4 | $ 69,640 | $ 14,898 | |||||
Issuance of common stock to 401(k) plan for employees, (in shares) | 96,959 | ||||||||||
Issuance of common stock to 401(k) plan for employees | $ 265 | 265 | |||||||||
Issuance of common stock for employee stock purchase plan (in shares) | 225,310 | ||||||||||
Issuance of common stock for employee stock purchase plan | $ 650 | 650 | |||||||||
Issuance of common stock upon exercise of stock options (in shares) | 3,542 | 3,542 | |||||||||
Issuance of common stock upon exercise of stock options | $ 13 | 13 | |||||||||
Restricted stock award grants, net of forfeitures (in shares) | 3,589,761 | ||||||||||
Restricted stock award grants, net of forfeitures | 0 | $ 4 | (4) | ||||||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 861 | ||||||||||
Issuance of common stock upon vesting of restricted stock units | $ 0 | ||||||||||
Ending Balance, (in shares) at Dec. 31, 2020 | 146,083,110 | 146,083,110 | |||||||||
Ending Balance at Dec. 31, 2020 | $ 134,243 | $ 146 | $ 1,021,221 | $ (1,829) | $ (885,295) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash Flows From Operating Activities: | ||
Loss from continuing operations | $ (171,272) | $ (135,386) |
Income from discontinued operations, net of income taxes | 10,404 | 22,697 |
Net loss | (160,868) | (112,689) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 261 | 1,620 |
Stock-based compensation | 17,819 | 21,838 |
Impairment of second source manufacturer | 28,197 | 0 |
Recognized gain on Commercial Product Portfolio Transaction | 0 | (34,568) |
Non-cash lease expense | 1,540 | 1,715 |
Accretion (amortization) of premium (discount) on debt securities | 220 | (431) |
Realized gain on mutual funds | (232) | 0 |
Income tax recognition on unrealized gain on available-for-sale securities | 0 | (205) |
Realized gain on sale of equity holdings | (1,408) | (2,674) |
Unrealized loss on equity holdings | 4,487 | 12,665 |
Unrealized loss (gain) from transactions denominated in foreign currency | 495 | (6) |
Change in deferred tax liabilities | 0 | (1,469) |
Change in fair value of contingent consideration | 0 | 1,478 |
Bad debt expense (recovery) | 389 | (12) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 0 | 29,420 |
Other receivables | 7,165 | (5,871) |
Inventories | 0 | (2,037) |
Prepaid expenses and other current assets | 1,159 | (2,473) |
Other assets | (317) | (1,188) |
Accounts payable and other accrued liabilities | (22,053) | (35,769) |
Accrued payroll and benefits | 1,689 | (2,168) |
FOLOTYN development liability | 0 | (4) |
Contract liabilities | 0 | (4,850) |
Other long-term liabilities | (172) | 3,047 |
Net cash used in operating activities | (121,629) | (134,631) |
Cash Flows From Investing Activities: | ||
Proceeds from Commercial Product Portfolio Transaction | 0 | 158,571 |
Proceeds from maturities of investments | 109,035 | 77,475 |
Proceeds from sale of equity holdings | 3,954 | 5,074 |
Purchases of investments | (89,382) | (200,160) |
Purchases of property and equipment, net | (5,535) | (9,018) |
Proceeds from sale of property and equipment, net | 0 | 50 |
Net cash provided by investing activities | 18,072 | 31,992 |
Cash Flows From Financing Activities: | ||
Proceeds from employees for exercises of stock options | 13 | 7,147 |
Proceeds from sale of stock under our employee stock purchase plan | 650 | 663 |
Net cash provided by financing activities | 85,230 | 9,627 |
Effect of exchange rates on cash and cash equivalents | (82) | (50) |
Net decrease in cash and cash equivalents | (18,409) | (93,062) |
Cash and cash equivalents — beginning of year | 64,418 | 157,480 |
Cash and cash equivalents — end of year | 46,009 | 64,418 |
Supplemental Disclosure of Cash Flow Information: | ||
Cash paid for facility and equipment under operating leases | 2,401 | 1,835 |
Cash paid for income taxes | 14 | 38 |
Noncash investing activities: | ||
Additions of property and equipment that remain in accounts payable and other accrued liabilities | 10,066 | 2,760 |
Public Offering | ||
Cash Flows From Financing Activities: | ||
Proceeds from issuance of common stock | 69,665 | 0 |
At-the-market Sales Agreement | ||
Cash Flows From Financing Activities: | ||
Proceeds from issuance of common stock | $ 14,902 | $ 1,817 |
Description of Business, Basis
Description of Business, Basis of Presentation, and Operating Segment | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Description of Business, Basis of Presentation, and Operating Segment | DESCRIPTION OF BUSINESS, BASIS OF PRESENTATION, AND OPERATING SEGMENT (a) Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharmaceutical company, with a primary strategy comprised of acquiring, developing, and commercializing novel and targeted oncology therapies. Our in-house development organization includes clinical development, regulatory, quality and data management. We continue to build out our commercial and marketing capabilities to prepare for the launch of ROLONTIS. We have three drugs in development: • ROLONTIS, a novel long-acting granulocyte colony-stimulating factor (“G-CSF”) for chemotherapy-induced neutropenia, which is under review by the U.S. Food and Drug Administration (the “FDA”). On October 26, 2020, the Company announced that the FDA had deferred action on the Biologics License Application (“BLA”) for ROLONTIS due to the inability to conduct an inspection of our third-party manufacturing facility in South Korea as a result of COVID-19 related travel restrictions. In March 2021, the FDA scheduled the pre-approval inspection of the Hanmi manufacturing facility for May 2021; • Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations. A New Drug Application (“NDA”) based on data from Cohort 2 of ZENITH20, which evaluated previously treated patients with NSCLC with HER2 exon 20 insertion mutation is expected to be filed with the FDA in 2021; and • Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma patients. Our business strategy is the development of our late-stage assets through commercialization and the sourcing of additional assets that are synergistic with our existing portfolio (through purchase acquisitions, in-licensing transactions, or co-development and marketing arrangements). (b) Basis of Presentation Principles of Consolidation The accompanying Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and with the rules and regulations of the Securities and Exchange Commission (“SEC”). These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. In May 2019, we dissolved Spectrum Pharma Canada Inc., previously consolidated as a “variable interest entity” (as defined under applicable GAAP). Discontinued Operations - Sale of our Commercial Product Portfolio On March 1, 2019, we completed the sale of our seven then-commercialized drugs, including FUSILEV, KHAPZORY, FOLOTYN, ZEVALIN , MARQIBO, BELEODAQ, and EVOMELA (the “Commercial Product Portfolio”) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). Upon closing we received $158.8 million in an upfront cash payment. We are also entitled to receive up to an aggregate of $140 million upon Acrotech’s future achievement of certain regulatory milestones (totaling $40 million) and sales-based milestones (totaling $100 million) relating to the Commercial Product Portfolio. (c) Operating Segment |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 12 Months Ended |
Dec. 31, 2020 | |
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) gross-to-net revenue adjustments; (ii) the timing of revenue recognition; (iii) the collectability of customer accounts; (iv) whether the cost of our inventories can be recovered; (v) the realization of our tax assets and estimates of our tax liabilities; (vi) the fair value of our investments; (vii) the valuation of our stock options and the periodic expense recognition of stock-based compensation; and (viii) the potential outcome of our ongoing or threatened litigation. Our accounting policies and estimates that most significantly impact the presented amounts within these Consolidated Financial Statements are further described below: (i) Revenue Recognition On March 1, 2019, we completed the Commercial Product Portfolio Transaction. In accordance with applicable GAAP ( ASC 205-20, Presentation of Financial Statements ), the revenue-deriving activities of our sold commercial operation are separately classified as “discontinued” for all periods presented within the accompanying Consolidated Statements of Operations. Required Elements of Our Revenue Recognition : Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (“Topic 606”) in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements: (1) we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable; (2) we identify the “performance obligations” in the respective contract; (3) we determine the “transaction price” for each performance obligation in the respective contract; (4) we allocate the transaction price to each performance obligation; and (5) we recognize revenue only when we satisfy each performance obligation. These five elements, as applied to each of our revenue categories, are summarized below: (a) Product Sales : We sell our products to pharmaceutical wholesalers/distributors or to our product licensees (i.e., our customers). Our wholesalers/distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration. Our gross product sales (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in reported “product sales, net” that reflects the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and group purchasing organization (“GPO”) administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales. These GTN estimate categories (that comprise our GTN liabilities) are each discussed below: Product Returns Allowances : Our customers are contractually permitted to return certain purchased products within the contractual allowable time before/after its applicable expiration date. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns using our historical return rates. Returned product is typically destroyed since substantially all are due to its imminent expiry and cannot be resold. Government Chargebacks : Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers. Prompt Pay Discounts : Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage. Commercial Rebates : Commercial rebates are based on (i) our estimates of end-user purchases through a GPO, (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us. Medicaid Rebates : Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in our receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment. Distribution, Data, and GPO Administrative Fees : Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products for various commercial services including: contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales. (b) License Fees : Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (i) upfront license fees, (ii) sales royalties, (iii) sales milestone-achievement fees, and (iv) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows: (1) Upfront License Fees: We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer). (2) Royalties : Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt. (3) Sales Milestones : Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt. (4) Regulatory Milestones : Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee. • When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” (i.e., not recognized) until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. • When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. (c) Service Revenue : We receive fees under certain arrangements for (i) sales and marketing services, (ii) supply chain services, (iii) research and development services, and (iv) clinical trial management services. Our rights to receive payment for these services may be established by (1) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (2) our completion of product delivery in our capacity as a procurement agent, (3) the successful completion of a phase of drug development, (4) favorable results from a clinical trial, and/or (5) regulatory approval events. We consider whether revenue associated with these service arrangements is reportable each period, based on our completed services or deliverables (i.e., satisfied “performance obligations”) during the reporting period, and the terms of the arrangement that contractually result in fixed payments due to us. The promised service(s) within these arrangements are distinct and explicitly stated within each contract, and our customer benefits from the separable service(s) delivery/completion. Further, the nature of the promise to our customer as stated within the respective contract is to deliver each named service individually (not a transfer of combined items to which the promised goods or services are inputs), and thus are separable for revenue recognition. (ii) Cash and Cash Equivalents Cash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. (iii) Marketable Securities Marketable securities consist of our holdings in mutual funds, bank CDs, government-related debt securities, and corporate debt securities. Since we classify these investments as “available-for-sale” any (1) realized gains (losses) or (2) unrealized gains (losses) on these securities are respectively recognized in (1) “other income (expense), net” on the accompanying Consolidated Statements of Operations, or (2) depending on the nature of the marketable securities recognized in “accumulated other comprehensive loss” as a separate component of stockholder’s equity on the accompanying Consolidated Statements of Stockholders’ Equity, or in “other income (expense), net” on the accompanying Consolidated Statements of Operations. We classify our equity securities within marketable securities as well, with any gains or losses recorded within “other income (expense), net” within the Consolidated Statements of Operations. (iv) Accounts Receivable, Net Our accounts receivable, net of allowance for credit losses, are derived from our product sales and license fees, and do not bear interest. The allowance for credit losses is management’s best estimate of the amount of expected credit losses in our existing accounts receivable and any anticipated discounts. The allowance for credit losses is adjusted each period through earnings to reflect expected credit losses over the remaining life of the asset. Account balances are written off against the allowance after appropriate collection efforts are exhausted. In June 2016, the Financial Accounting Standards Board issued ASU No. 2016-13 ("ASU 2016-13") "Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments" , which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. This new ASU replaces the existing incurred loss impairment model with a current expected credit loss model (“CECL”), which requires the use of forward-looking information to calculate credit loss estimates. The new CECL model requires recognition of credit losses for loans and other receivables at the time the financial asset is originated or acquired, in which the expected credit losses are adjusted each period for changes in expected lifetime credit losses. The new standard also applies to receivables arising from revenue transactions such as contract assets and accounts receivables and requires credit losses related to certain available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. We adopted ASU 2016-13 as of January 1, 2020, which did not have a material effect on our accompany Consolidated Financial Statements. (v) Inventories We value our inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its net realizable value, which takes into account our sales forecast by product and corresponding expiry dates of each product lot. Manufacturing costs of drug products that are pending FDA approval during clinical development and trials, and at-risk inventory build in anticipation of commercialization, are exclusively recognized through “research and development” expense on the accompanying Consolidated Statements of Operations. (vi) Property and Equipment, Net Our property and equipment, net, is stated at historical cost, and is depreciated on a straight-line basis over an estimated useful life that corresponds with its designated asset category. We evaluate the recoverability of long-lived assets (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable. Recoverability is measured by a comparison of the carrying amount to the net undiscounted cash flows expected to be generated by the asset group. An impairment loss would be recorded for the excess of net carrying value over the fair value of the asset impaired. The fair value is estimated based on expected discounted future cash flows or other methods such as orderly liquidation value based on assumptions of asset class and observed market data. An orderly liquidation value is the amount that could be realized upon liquidation, given a sufficient amount of time to find a purchaser for a sale of assets in their existing condition and location, as of a specific date, and assuming the sale is to market participants who can utilize such assets in their highest and best use. The orderly liquidation values are applied against the carrying values of the assets and the impairment loss is measured as the difference between the liquidation value and the carrying value of the assets. See Note 4(d) for further discussion about an impairment that occurred during the fourth quarter of 2020. In August 2018, the FASB issued Accounting Standards Update No. 2018-15, Intangibles – Goodwill and other – Internal-Use Software (Subtopic 350-40), which amended its guidance for costs of implementing a cloud computing service arrangement and aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software, and to expense such capitalized implementation costs over the term of the hosting arrangement. The guidance is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. On January 1, 2021, we adopted this standard on a prospective basis for applicable implementation costs, which did not have a material impact on our consolidated financial statements. (vii) Stock-Based Compensation Stock-based compensation expense for equity awards granted to our employees and members of our Board of Directors is recognized on a straight-line basis over each award’s vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited prior to vesting, though is ultimately adjusted for actual forfeitures. We use the Black-Scholes option pricing model to determine the fair value of stock options and stock appreciation rights (as of the date of grant) that have service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) that have combined market conditions and service conditions for vesting. The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term that the stock option will remain outstanding, (c) our stock price volatility over the expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the prevailing risk-free interest rate for the period matching the expected term. With regard to (a)-(d) above: we estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on the historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option. (viii) Basic and Diluted Net Loss per Share We calculate basic and diluted net loss per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period. (ix) Income Taxes Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. We have recorded a valuation allowance to reduce our deferred tax assets, 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 Consolidated Statements of Operations for the period in which we received the notice. (x) Research and Development Expenses Our research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, benefits, and other staff-related costs including associated stock-based compensation, laboratory supplies, clinical trial and related clinical manufacturing costs, costs related to manufacturing preparations, fees paid to other entities that conduct certain research and development activities on our behalf and payments made pursuant to license agreements. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. We accrue for costs incurred as the services are being provided by monitoring the status of activities and the invoices received from its external service providers. We adjust our accruals as actual costs become known. Where contingent milestone payments are due to third parties under research and development or license agreements, the milestone payment obligations are expensed when the clinical or regulatory milestone results are achieved. (xi) Fair Value Measurements We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. Level 3: Unobservable inputs are used when little or no market data is available. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The table below summarizes certain asset and liability fair values that are included within our accompanying Consolidated Balance Sheets, and their designations among the three fair value measurement categories: December 31, 2020 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 40,560 $ — $ — $ 40,560 Equity securities 24,946 — — 24,946 Government-related debt securities 92,928 — — 92,928 Corporate debt securities — 8,848 — 8,848 Mutual funds 5,573 9 — 5,582 Bank CDs — 1,721 — 1,721 Key employee life insurance, cash surrender value (1) — 3,963 — 3,963 $ 164,007 $ 14,541 $ — $ 178,548 Liabilities: Deferred executive compensation liability (2) $ — $ 9,783 $ — $ 9,783 $ — $ 9,783 $ — $ 9,783 (1) Included within other assets on our Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $1.3 million within accounts payable and other accrued liabilities and $8.5 million within other long-term liabilities on our Consolidated Balance Sheets. The amounts are based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 54,199 $ — $ — $ 54,199 Equity securities 31,047 — — 31,047 Government-related debt securities 47,636 14,990 — 62,626 Corporate debt securities — 58,248 — 58,248 Mutual funds 5,158 11 — 5,169 Bank CDs — 7,376 — 7,376 Key employee life insurance, cash surrender value (1) — 3,547 — 3,547 $ 138,040 $ 84,172 $ — $ 222,212 Liabilities: Deferred executive compensation liability (2) $ — $ 8,746 $ — $ 8,746 $ — $ 8,746 $ — $ 8,746 (1) Included within other assets on our Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $0.1 million within accounts payable and other accrued liabilities and $8.6 million within other long-term liabilities on our Consolidated Balance Sheets. The amounts are based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. We did not have any transfers between “Level 1” and “Level 2” measurement categories for any periods presented. |
Balance Sheet Account Detail
Balance Sheet Account Detail | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Account Detail | BALANCE SHEET ACCOUNT DETAIL The composition of selected financial statement captions that comprise the accompanying Consolidated Balance Sheets are summarized below: (a) Cash and Cash Equivalents and Marketable Securities We maintain cash balances with select major financial institutions. The Federal Deposit Insurance Corporation (FDIC) and other third parties insure a fraction of these deposits. Accordingly, these cash deposits are not insured against the possibility of a substantial or complete loss of principal and are inherently subject to the credit risk of the corresponding financial institution. Our investment policy requires that purchased investments may only be in highly-rated and liquid financial instruments and limits our holdings of any single issuer (excluding any debt or equity securities that may be received from our strategic partners in connection with an out-license arrangement). The carrying amount of our equity securities, money market funds, and bank CDs approximates their fair value (utilizing “ Level 1” or “ Level 2” inputs because of our ability to immediately convert these instruments into cash with minimal expected change in value. As of December 31, 2020, our held securities that remain in an unrealized loss position for less than one year were insignificant and are presented in the table below. The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Foreign Currency Translation Unrealized Unrealized Losses Fair Value Cash and Cash Marketable Securities December 31, 2020 Money market funds $ 40,560 $ — $ — $ — $ 40,560 $ 40,560 $ — Equity securities (1) 3,764 (1,546) 22,728 — 24,946 — 24,946 Government-related debt securities 92,881 — 47 — 92,928 — 92,928 Corporate debt securities 8,846 — 2 — 8,848 — 8,848 Mutual funds 4,497 — 1,076 — 5,573 — 5,573 Bank CDs 1,715 — 6 — 1,721 — 1,721 Bank deposits 5,449 — — — 5,449 5,449 — Total cash and cash equivalents and marketable securities $ 157,712 $ (1,546) $ 23,859 $ — $ 180,025 $ 46,009 $ 134,016 December 31, 2019 Money market funds $ 54,199 $ — $ — $ — $ 54,199 $ 54,199 $ — Equity securities 6,310 (2,477) 27,214 — 31,047 — 31,047 Government-related debt securities 62,617 — 19 (10) 62,626 — 62,626 Corporate debt securities 58,235 — 38 (25) 58,248 5,000 53,248 Mutual funds 4,375 — 783 — 5,158 — 5,158 Bank CDs 7,354 — 22 — 7,376 — 7,376 Bank deposits 5,219 — — — 5,219 5,219 — Total cash and cash equivalents and marketable securities $ 198,309 $ (2,477) $ 28,076 $ (35) $ 223,873 $ 64,418 $ 159,455 (1) Our aggregate equity holdings consist of 8.5 million common shares of CASI, a publicly-traded biopharmaceutical company (NASDAQ: CASI) as of December 31, 2020 represented less than 10.0% ownership with a fair market value of 24.9 million. During 2020, we completed the sale of 1.6 million common shares and recognized a $1.4 million gain within “other expense, net” within the accompanying Consolidated Statements of Operations for the year ended December 31, 2020. (b) Other Receivables “Other receivables” consists of the following: December 31, 2020 2019 Insurance receivable 5 4,015 CASI receivables — 2,393 Other miscellaneous receivables 896 1,490 Income tax receivable - current portion 1,297 973 Interest receivable from marketable securities 196 561 Reimbursements for incurred research and development expenses — 126 Other receivables $ 2,394 $ 9,558 (c) Prepaid Expenses and Other Current Assets “Prepaid expenses and other current assets” consists of the following: December 31, 2020 2019 Vendor deposits (1) 1,996 8,740 Prepaid insurance $ 2,165 $ 1,408 Prepaid expenses and other current assets $ 4,161 $ 10,148 (1) The decrease in vendor deposits relates to $8.5 million of cancelled manufacturing work at our second source contract manufacturer for ROLONTIS. See Note 4(d) for further discussion. (d) Property and Equipment, net “Property and equipment, net” consists of the following: December 31, 2020 2019 Manufacturing equipment $ 3,245 $ 10,355 Computer hardware and software 1,680 3,606 Laboratory equipment 5 36 Office furniture 248 248 Leasehold improvements 1,267 3,374 Property and equipment, at cost 6,445 17,619 (Less): Accumulated depreciation (2,868) (6,012) Property and equipment, net $ 3,577 $ 11,607 Manufacturing equipment is comprised of our owned ROLONTIS production equipment on location at our contract manufacturer. This equipment has alternative future use for the general production of various biologic agents. Accordingly, we have capitalized these purchases. The majority of this manufacturing equipment was not in use and therefore not being depreciated as of December 31, 2019. Depreciation expense of $0.3 million and $0.4 million, respectively, is included within the accompanying Consolidated Statements of Operations for the years ended December 31, 2020 and 2019. During the fourth quarter of 2020, we determined that we would no longer proceed with the technology transfer and validation of a second manufacturing source for ROLONTIS and communicated this decision to the second source manufacturer. We had invested significant capital to prepare this facility for production. Due to the decision to halt this work, we determined that the value of certain ROLONTIS production equipment had a carrying amount in excess of the anticipated recoverable value as there would be no future cash flows from these assets other than through the sale of this equipment. We determined the fair value of these assets under an orderly liquidation value method (see Note 2(vi)), and based on the valuation performed we recorded an impairment of $19.7 million to our carrying value for this equipment, which was recorded as research and development expense. Fair value was based on observable market data (Level 2). Due to the specialized nature of this production equipment, adjustments to observable market data were applied (Level 3). In connection with this decision, we additionally wrote off $8.5 million in prepaid costs related to future manufacturing activities that would no longer be taking place as research and development expense. (e) Accounts Payable and Other Accrued Liabilities “Accounts payable and other accrued liabilities” consists of the following: December 31, 2020 2019 Trade accounts payable and other $ 34,385 $ 32,012 Lease liability - current portion 1,544 1,683 Accrued commercial/Medicaid rebates 1,624 2,925 Accrued product royalty due to licensors — 66 Allowance for product returns 4,299 4,714 Accrued data and distribution fees 768 768 Accrued GPO administrative fees 6 6 Accrued inventory management fees 168 364 Allowance for government chargebacks 977 11,746 Accounts payable and other accrued liabilities $ 43,771 $ 54,284 Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Consolidated Balance Sheets for our categories of GTN estimates were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, Product Return Allowances Balance as of December 31, 2018 $ 22,952 $ 3,932 $ 5,171 Add: GTN accruals recorded for product sales 7,702 1,209 167 (Less): Payments made and credits against GTN accruals (15,983) (4,003) (624) Balance as of December 31, 2019 14,671 1,138 4,714 Add: GTN accruals recorded for product sales — — — (Less): Payments made and credits against GTN accruals (see Note 9 ) (12,070) (196) (415) Balance as of December 31, 2020 $ 2,601 $ 942 $ 4,299 . |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION 2018 Long-Term Incentive Plan We have one active stockholder-approved stock-based compensation plan, the 2018 Long-Term Incentive Plan (the “2018 Plan”). In June 2018, the 2018 Plan replaced our former 2009 Incentive Award Plan (the “2009 Plan”). Under the 2018 Plan, we may grant restricted stock awards and units, incentive and non-qualified stock options, performance unit awards, stock appreciation rights, and other stock-based awards to employees, consultants, and members of our Board of Directors. Stock-based awards generally vest one-third on the first anniversary of the date of grant, and in equal annual installments thereafter over the remaining two year vesting period. Stock options must generally be exercised, if at all, no later than 10 years from the date of grant. In the event of a change in control, all award types with the exception of performance unit awards, will vest in full effective immediately prior to the consummation of the change in control. For performance unit awards, if a change in control occurs prior to the end date and the participant remains employed prior to the change in control, the shares vest based on the achievement of the performance goals as of the date of which the change in control occurs. The stated maximum availability of common stock under the 2018 Plan is 18 million shares, except for additional availability provided on a one-for-one basis for awards formerly issued under the 2009 Plan that are terminated, forfeited, cancelled or expire unexercised. Awards issued under the 2018 Plan reduce share availability on a one-to-one basis for stock options and on a 1.5-to-one basis for restricted stock awards and restricted stock units. Accordingly, as of December 31, 2020, 8.2 million awards were available for grant under the 2018 Plan, assuming all were issued in the form of stock options, but would be reduced to 5.5 million awards available for grant if all were issued in the form of restricted stock. It is our policy that before stock is issued through the exercise of stock options, we must first receive all required cash payment for such shares (whether through an upfront cash exercise or net-settlement exercise). At the time of vesting of restricted stock, by our policy, requisite shares are automatically sold on the open market by our designated broker to the extent required to cover the employee’s federal and state taxes due. Stock-based awards are governed by agreements between us and the recipients. Incentive stock options and nonqualified stock options may be granted under the 2018 Plan at an exercise price of not less than 100% of the fair market value of our common stock on the respective date of grant and for certain recipients may not be less than 110% of such fair market value. The grant date is generally the date the terms of the award are approved by the Compensation Committee of our Board of Directors. Employee Stock Purchase Plan Under the terms of our 2009 Employee Stock Purchase Plan (the “ESPP”), eligible employees can purchase common stock through scheduled payroll deductions. The purchase price is equal to the closing price of our common stock on the first or last day of the offering period (whichever is less), minus a 15% discount. We use the Black-Scholes option-pricing model, in combination with the discounted employee price, in determining the value of ESPP expense to be recognized during each offering period. A participant may purchase a maximum of 50,000 shares of common stock during a six-month offering period, not to exceed $25,000 at full market value on the offering date during each plan year. As of December 31, 2020, a total of 8.5 million shares of common stock are authorized and remain available for issuance under the ESPP. Beginning on January 1, 2010, and each January 1st thereafter, the number of shares of common stock available for issuance under the ESPP shall automatically increase by an amount equal to the lesser of (i) one million shares or (ii) an amount determined by the ESPP administrator. However, in no event shall the number of shares of common stock available for future sale under the ESPP exceed 10 million shares, subject to capitalization adjustments occurring due to dividends, splits, dissolution, liquidation, mergers, or changes in control. Stock-Based Compensation Expense Summary We report our stock-based compensation expense (inclusive of our incentive stock plan, employee stock purchase plan, and 401(k) contribution matching program) in the accompanying Consolidated Statements of Operations within “total operating costs and expenses” for the years ended December 31, 2020 and 2019, as follows: Year Ended December 31, 2020 2019 Selling, general and administrative $ 13,127 $ 14,118 Research and development 4,692 4,316 Total stock-based compensation $ 17,819 $ 18,434 Employee stock-based compensation expense for the years ended December 31, 2020 and 2019 was recognized (reduced for estimated forfeitures) on a straight-line basis over the vesting period. Forfeitures are estimated at the time of grant and prospectively revised if actual forfeitures differ from those estimates. We estimate forfeitures of stock options using the historical exercise behavior of our employees. For purposes of this estimate, we have applied an estimated forfeiture rate of 15% and 16% for the years ended December 31, 2020 and 2019, respectively. Valuation Assumptions The grant-date fair value per share for restricted stock awards was based upon the closing market price of our common stock on the award grant-date. The fair value of stock options granted was estimated at the date of grant using the Black-Scholes option-pricing model. The following assumptions were used to determine fair value for the stock awards granted in the applicable year: Year Ended December 31, 2020 2019 Expected option life (in years) (a) 5.46 5.34 Risk-free interest rate (b) 0.34% - 1.61% 1.47% - 2.49% Volatility (c) 74.5% - 81.4% 61.6% - 76.1% Dividend yield (d) 0% 0% Weighted-average grant-date fair value per stock option $1.63 $5.85 (a) Determined by the historical stock option exercise behavior of our employees (maximum term is 10 years). (b) Based upon the U.S. Treasury yields in effect during the period which the options were granted (for a period equaling the stock options’ expected term). (c) Measured using our historical stock price for a period equal to stock options’ expected term. (d) We do not expect to declare any cash dividends in the foreseeable future. Stock Option Activity Stock option activity during the years ended December 31, 2020 and 2019 was as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2018 6,843,585 $ 8.98 Granted 1,113,081 10.54 Exercised (1,121,403) 6.38 $ 2,919 (1) Forfeited (172,074) 9.84 Expired (223,253) 11.09 Outstanding — December 31, 2019 6,439,936 9.61 Granted 2,032,000 2.34 Exercised (3,542) 3.70 $ 708 (1) Forfeited (170,187) 8.29 Expired (641,584) 8.55 Outstanding — December 31, 2020 7,656,623 $ 7.80 6.33 $ 2,184 (2) Vested (exercisable) — December 31, 2020 5,221,749 $ 8.65 5.19 $ 503 (2) Unvested (unexercisable) — December 31, 2020 2,434,874 $ 5.98 8.75 $ 1,397 (2) (1) Represents the total difference between our closing stock price at the time of exercise and the stock option exercise price, multiplied by the number of options exercised. (2) Represents the total difference between our closing stock price on the last trading day of 2020 and the stock option exercise price, multiplied by the number of in-the-money options as of December 31, 2020. The amount of intrinsic value will change based on the fair market value of our stock. The following table summarizes information with respect to stock option grants as of December 31, 2020: Outstanding Exercisable Exercise Price Granted Stock Weighted- Weighted- Granted Weighted- $1.47 - 4.96 2,004,807 9.2 $ 2.36 426,557 $ 2.30 $4.97 - 6.91 1,953,056 5.33 6.00 1,899,501 6.00 $6.92 - 9.00 1,628,613 3.88 7.86 1,482,404 7.81 $9.01 - 12.00 968,289 6.59 11.15 566,565 11.02 $12.01 - 22.64 1,101,858 6.26 17.89 846,722 17.70 7,656,623 6.33 $ 7.80 5,221,749 $ 8.65 As of December 31, 2020, there was unrecognized compensation expense of $4.6 million related to unvested stock options, which we expect to recognize over a weighted average period of 1.8 years. Restricted Stock Award Activity A summary of restricted stock award activity is as follows: Number of Weighted Average Unvested — December 31, 2018 1,802,130 $ 12.75 Granted 1,091,353 10.50 Vested (972,404) 11.70 Forfeited (261,320) 11.48 Unvested — December 31, 2019 1,659,759 11.67 Granted 4,026,518 2.68 Vested (753,475) 11.23 Forfeited (436,757) 6.03 Unvested — December 31, 2020 4,496,045 $ 4.29 For the years ended December 31, 2020 and 2019, we recorded stock-based compensation expense on our issued restricted share awards of $9.4 million and $9.2 million, respectively. As of December 31, 2020, there was approximately $12.3 million of unrecorded expense that will be recognized over an estimated weighted average period of 1.9 years. These unvested shares are included in our reported issued and outstanding common stock as of December 31, 2020. Restricted Stock Unit Activity Our outstanding restricted stock units substantially relate to awards that contain “market-based” vesting conditions that are issued to our executive officers. These conditions are specified in each award agreement and result in a variable number of shares that become issuable at the assessment date, after review and approval by our Compensation Committee. A summary of restricted stock unit activity is as follows: Number of Weighted Average Outstanding — December 31, 2018 255,214 $ 17.91 Granted 257,585 12.87 Market-based achievement adjustment at vesting 116,880 6.49 Share issuance (243,760) 7.04 Outstanding — December 31, 2019 385,919 18.00 Granted 6,800 2.36 Market-based achievement adjustment at vesting (128,334) — Share issuance (861) 10.69 Outstanding — December 31, 2020 263,524 $ 26.39 For the years ended December 31, 2020 and 2019, we recorded stock-based compensation expense on our issued restricted stock units of $1.1 million and $3.0 million, respectively. As of December 31, 2020, there was approximately $1.1 million of unrecorded expense that will be recognized over an estimated weighted average period of 1 year. Stock Appreciation Rights Starting in 2020, we granted 1,650,000 stock appreciation rights (“SARs”) to our Named Executive Officers. On the date of grant, the fair value of these SARs were estimated using the Black-Scholes option-pricing model and 25% immediately vested. There were no forfeitures made during the year. We recognized stock-based compensation expense of $1.5 million and $0, respectively, within our Consolidated Statements of Operations for the years ended December 31, 2020 and 2019. As of December 31, 2020, there was approximately $1.1 million of unrecorded expense that will be recognized over an estimated weighted average period of 2.3 years. 401(k) Plan – Stock Matching Contribution During the year ended December 31, 2020 and 2019, respectively, we issued 96,959 and 225,780 common shares related to 401(k) plan matching, and recorded stock-based compensation expense of $0.3 million and $1.3 million, respectively. Beginning in March 2020, we made the decision to match our employees’ annual 401(k) contributions with cash rather than stock moving forward. As a result of this change, the shares issued to participants 401(k) accounts were substantially lower in the current year period compared to prior year periods. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Authorized Stock In June 2018, our stockholders approved an amendment and restatement of our Certificate of Incorporation to reflect an increase in the number of authorized shares of our common stock from 175 million shares to 300 million shares. In addition to the increase in the authorized number of shares of common stock, the amendment eliminates designated series of preferred stock that are obsolete and are no longer outstanding or issuable, including Series B Junior Participating Preferred Stock and Series E Convertible Voting Preferred Stock. As of December 31, 2020, we had five million shares of preferred stock authorized and no shares of preferred stock outstanding. Stockholder Rights Agreement On November 29, 2010, our Board of Directors approved a stockholder rights agreement (the “Stockholder Rights Agreement”), effective December 13, 2010. A stockholder rights agreement is designed to deter coercive, unfair, or inadequate takeovers and other abusive tactics that might be used in an attempt to gain control of our company. A stockholder rights agreement will not prevent takeovers at a full and fair price, but rather is designed to deter coercive takeover tactics and to encourage anyone attempting to acquire our company to first negotiate with our Board of Directors. On March 27, 2018, we entered into a Second Amendment to Rights Agreement which had the effect of suspending the Stockholders Rights Agreement as of March 30, 2018. On December 13, 2020, the Stockholder Rights Agreement expired under its terms. Common Stock Issuable Upon Exercise of Stock Options and Vesting of Restricted Stock Units As of December 31, 2020, (i) 5.2 million shares of our common stock are issuable upon the exercise of outstanding stock options (regardless of whether in or out-of-the-money) and (ii) 0.5 million shares of our common stock are issuable if the maximum market conditions of our outstanding restricted stock unit agreements are met. Public Offering of Common Stock On July 30, 2020, we announced the pricing of an underwritten public offering of 21,666,667 shares of our common stock at a public offering price of $3.00 per share. The net proceeds from the offering were approximately $61.1 million, after deducting underwriting discounts and commissions. In addition, we granted the underwriters a 30-day option to purchase up to an additional 3,250,000 shares of common stock. On August 3, 2020, the underwriters fully exercised their option to purchase an additional 3,250,000 shares of our common stock at the public offering price of $3.00 per share, less underwriting discounts and commissions, for additional net proceeds of approximately $9.2 million. After giving effect to the exercise in full of the underwriters’ option, the total number of shares sold in the public offering was 24,916,667 shares and net proceeds were approximately $69.7 million, net of underwriting discounts and offering expenses of $5.0 million. Sale of Common Stock Under ATM Agreements On April 5, 2019, we entered into a new collective at-market-issuance (“ATM”) sales agreement with Cantor Fitzgerald & Co., H.C. Wainwright & Co., LLC and B. Riley FBR, Inc. (the “April 2019 ATM Agreement”), pursuant to which we may offer and sell shares of our common stock by any method deemed to be an “at the market” offering (the “ATM Offering”). From April 5, 2019 to March 2, 2020, the ATM Offering was conducted pursuant to a sales agreement prospectus filed with our automatic shelf registration statement on Form S-3ASR, filed with the SEC on April 5, 2019, which registered an aggregate offering price of $150 million under the April 2019 ATM Agreement. From May 8, 2020 to June 30, 2020, the ATM Offering was conducted pursuant to a sales agreement prospectus (the “Initial Sales Agreement Prospectus”) filed with our shelf registration statement on Form S-3, filed with the SEC on March 20, 2020, as amended by Pre-Effective Amendment No. 1 thereto, and declared effective by the SEC on May 8, 2020 (the “Registration Statement”), which registered an aggregate offering price of up to $75 million under the April 2019 ATM Agreement. On July 29, 2020, we terminated the Initial Sales Agreement Prospectus, but left the April 2019 ATM Agreement in full force and effect. On November 6, 2020, we filed a new sales agreement prospectus to the Registration Statement, which registered an aggregate offering price of up to $60 million under the April 2019 ATM Agreement. We sold and issued common shares under the April 2019 ATM Agreement as follows: Description of Financing Transaction No. of Common Shares Issued Proceeds Received (Net of Broker Commissions and Fees ) Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2019 221,529 $ 1,814 Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2020 3,950,398 $ 14,902 These proceeds and any future proceeds raised will support the advancement of our in-development drug candidates, activities in connection with the launch of these drugs (including the hiring of personnel, building inventory supply and equipment purchases), completing acquisitions of assets, businesses, or securities, and for all other working capital purposes. |
Financial Commitments & Conting
Financial Commitments & Contingencies and Key License Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Financial Commitments & Contingencies and Key License Agreements | FINANCIAL COMMITMENTS & CONTINGENCIES AND KEY LICENSE AGREEMENTS(a) Facility and Equipment Leases Overview In the ordinary course of our business, we enter into leases with unaffiliated parties for the use of (i) office and research facilities and (ii) office equipment. Our current leases have remaining terms ranging from one year to three 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, 2021. 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 recognize lease expense on a straight-line basis over the expected term of these operating leases, as reported within “selling, general and administrative” expense on the accompanying Consolidated Statements of Operations. Our facility leases have minimum annual rents, payable monthly, and some carry fixed annual rent increases. Under some of these arrangements, real estate taxes, insurance, certain operating expenses, and common area maintenance are reimbursable to the lessor. These amounts are expensed as incurred, as they are variable in nature and therefore excluded from the measurement of our reported lease asset and liability discussed below. As of December 31, 2020 and 2019, we had no sublease arrangements with us as lessor, and no finance leases as defined in Topic 842 . This 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). Upon adoption, we recorded $4.2 million to our January 1, 2019 balance sheet for both (i) our right-of-use (“ROU”) asset within “facility and equipment under lease” and (ii) our lease liability within “accounts payable and other accrued liabilities” and “other long-term liabilities.” The recorded asset and liability associated with each lease is amortized over the respective lease term using the effective interest rate method. During the year ended December 31, 2020, we recognized no additional ROU assets in exchange for lease liabilities. During the year ended December 31, 2019, we recogniz ed $5.3 million of ROU assets in exchange for $5.3 million of l ease 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 these lease asset and liability accounts presented on our accompanying Consolidated Balance Sheets: Operating Leases Consolidated Balance Sheet Caption December 31, 2020 December 31, 2019 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 2,247 $ 3,806 Operating lease liabilities - current Accounts payable and other accrued liabilities $ 1,544 $ 1,683 Operating lease liabilities - non-current Other long-term liabilities 883 2,372 Total lease liabilities $ 2,427 $ 4,055 As of December 31, 2020 and December 31, 2019, our “facility and equipment under lease” consisted of office and research faciliti es of $1.9 million an d $3.4 million, respectively, and office equipment of $0.3 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 Consolidated Statements of Operations. The components of our aggregate lease expense is summarized below: Year Ended December 31, 2020 Year Ended December 31, 2019 Operating lease cost $ 1,865 $ 1,660 Variable lease cost 411 470 Short-term lease cost 61 77 Total lease cost $ 2,337 $ 2,207 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of December 31, 2020 1.6 years 7.8% Operating leases as of December 31, 2019 2.5 years 7.8% Future Contractual Lease Payments The below table summarizes our (i) minimum lease payments over the next five years, (ii) lease arrangement implied interest, and (iii) present value of future lease payments: Operating Leases - future payments December 31, 2020 2021 $ 1,670 2022 828 2023 87 2024 — 2025 — Total future lease payments, undiscounted $ 2,585 (Less): Implied interest (158) Present value of operating lease payments $ 2,427 (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 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. 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. Impact of Commercial Product Portfolio Transaction In March 2019, we completed the Commercial Product Portfolio Transaction and substantially all of the contractual rights and obligations associated with the Commercial Product Portfolio were transferred to Acrotech at the closing of the Commercial Product Portfolio Transaction. However, under the terms of this transaction we retained our trade “accounts receivable” and GTN liabilities included within “accounts payable and other accrued liabilities” associated with our product sales made on and prior to February 28, 2019. Accordingly, these Consolidated Financial Statements reflect the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations”. The most significant remaining agreements associated with our continuing operations are listed below, along with the key financial terms and our corresponding accounting and reporting conventions for each: (i) ROLONTIS: Co-Development and Commercialization Agreement with Hanmi Pharmaceutical Co. Ltd In October 2014, we exercised our option under a License Option and Research Collaboration Agreement dated January 2012 (as amended) with Hanmi Pharmaceutical Co. Ltd., or Hanmi, for ROLONTIS, a drug based on Hanmi’s proprietary LAPSCOVERY™ technology for the treatment of chemotherapy induced neutropenia. Under the terms of this agreement, as amended, we have primary financial responsibility for the ROLONTIS development plan and hold its worldwide rights (except for Korea, China, and Japan). We are contractually obligated to pay Hanmi tiered royalties that range from the low double-digits to mid-teens on our annual net sales of ROLONTIS. In January 2016, the first patient was dosed with ROLONTIS in a clinical trial. This triggered our contractual milestone payment to Hanmi, and in April 2016, we issued 318,750 shares of our common stock to Hanmi. We are responsible for regulatory milestone payments to Hanmi of $10 million upon approval of ROLONTIS, and sales milestone payments of up to $120 million per calendar year based on our annual net sales of ROLONTIS. Depending on the milestone achievement type 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 corresponding liability for the payment due to the 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. (ii) Poziotinib: In-License Agreement with Hanmi and Exclusive Patent and Technology License Agreement with MD Anderson In February 2015, we executed an in-license agreement with Hanmi for poziotinib, a pan-HER inhibitor in Phase 2 clinical trials (which has also shown single agent activity in the treatment of various cancer types during Phase 1 studies, including breast, gastric, colorectal, and lung cancers) and made an upfront payment to Hanmi for these distribution rights. Under the terms of this agreement, we received the exclusive global rights to commercialize poziotinib, except for Korea and China. Hanmi and its development partners are fully responsible for the completion of on-going Phase 2 trials in Korea. We are financially responsible for all other clinical studies. We are obligated to make contractual payments to Hanmi upon our achievement of various regulatory milestones that aggregate to $33 million. We are also obligated to pay Hanmi net sales milestones of up to $325 million annually and pay royalties in the low to mid-teen digits on our net sales of poziotinib, potentially reduced by royalties due to other third parties. In April 2018, we executed an exclusive patent and technology agreement for the use of poziotinib in treating patients with EGFR and HER2 exon 20 mutations in cancer and HER2 exon 19 mutations in cancer with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”). MD Anderson discovered poziotinib’s use in treating these patient-types. We made an upfront payment to MD Anderson of $0.5 million upon the execution of this agreement. We are contractually obligated to pay nominal fixed annual license maintenance fees to MD Anderson and pay additional fees upon our achievement of various regulatory and sales milestones. These regulatory milestones aggregate $6 million and the sales milestones aggregate $24 million. We are also contractually obligated to pay MD Anderson royalties in the low single-digits on our net sales of poziotinib. Depending on 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” on 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. (iii) In-License Agreement with ImmunGene for FIT Drug Delivery Platform In April 2019, we executed an asset transfer, license, and sublicense agreement with ImmunGene, Inc. (“ImmunGene”) for an exclusive license for the intellectual property related to (a) Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma patients, representing a considerable unmet medical need, and (b) an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies that have the potential for treating both solid and hematologic malignancies. Both molecules are based on the Focused Interferon Therapeutics (“FIT”) drug delivery platform. We made upfront payments aggregating $2.8 million to ImmunGene and to several other third parties, all of which were recorded within “research and development” expense within our accompanying Consolidated Statements of Operations for the year ended December 31, 2019. We will make further payments to ImmunGene upon our achievement of various regulatory milestones that aggregate to $26.1 million, plus an additional $5 million milestone payment for each new indication (beyond those described above) approved for either drug in the U.S., Europe, or Japan. Our contractual royalties to ImmunGene are in the high-single digits on our net sales of each drug, potentially reduced by our royalties due to other third parties. We are also contractually obligated to pay nominal fixed annual license maintenance fees to two licensors. 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. (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 accompanying Consolidated Statements of Operations for the year ended December 31, 2020. We will make an additional upfront payment of $2.2 million upon our acceptance of certain transferred materials from Therapyx. We will make further payments to Therapyx upon our achievement of various (i) regulatory milestones aggregating up to $30 million for the first approved IL-12 product, plus an additional $2.5 million milestone payment for each new indication approved for each product in the U.S., Europe, or Japan; and (ii) sales milestones aggregating up to $167.5 million based on worldwide annual net sales. We are contractually obligated to pay royalties in the mid-single digits on our net sales of all IL-12 products, potentially reduced by royalties due to third parties, the loss of IP protection within one or more countries, or the introduction of a competing product within one or more countries. Depending on the nature of the milestone achievement type we will either (a) capitalize the payment value to “intangible assets” in the Consolidated Balance Sheets or (b) recognize the payment value within “research and development” or “cost of sales” within the Consolidated Statements of Operations. The corresponding liability for the payment due to this licensor will be recognized in the Consolidated Balance Sheets within “accounts payable and other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or occurs. (c) Service Agreements for Research and Development Activities We have entered into various contracts with numerous third-party service providers for the execution of our research and development initiatives. These vendors include raw material suppliers, clinical trial sites, clinical research organizations, and data monitoring centers, among others. The financial terms of these agreements are varied and generally obligate us to pay in stages, depending on the achievement of certain events specified in the agreements - such as contract execution, progress of service completion, delivery of drug supply, and the dosing of patients in clinical studies. We recognize these “research and development” expenses and corresponding “accounts payable and other accrued liabilities” in the accompanying financial statements based on estimates of our vendors’ progress of performed services, patient enrollments and dosing, completion of clinical studies, and other events. Should we decide to discontinue and/or slow-down the work on any project, the associated costs for those projects would typically be limited to the extent of the work completed, as we are generally able to terminate these contracts with adequate notice. (d) Supply and Service Agreements Associated with Product Production We have various product supply agreements and/or have issued vendor purchase orders that obligate us to agreed-upon raw material purchases from certain vendors. We also have certain drug production service agreements with select contract manufacturers that obligate us to service fees during the contractual period. These collective commitments do not exceed our planned commercial requirements; the corresponding contracted prices do not exceed their current fair market values. (e) Employment Agreements We entered into revised employment agreements with each of our named executive officers (chief executive officer, chief operating officer, chief financial officer, chief legal officer, and chief medical officer) in April/June 2018 and June 2019, which supersede any prior change in control severance agreements with such individuals. These agreements provide for the payment of certain benefits to each executive upon his separation of employment under specified circumstances. These arrangements are designed to encourage each to act in the best interests of our stockholders at all times during the course of a change in control event or other significant transaction. (f) Deferred Compensation Plan The Spectrum Pharmaceuticals, Inc. Deferred Compensation Plan (the “DC Plan”) is administered by the Compensation Committee of our Board of Directors and is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended. The DC Plan is maintained to provide special deferred benefits for a select group of our employees (the “DC Participants”). DC Participants make annual elections to defer a portion of their eligible cash compensation which is then placed into their DC Plan accounts. We match a fixed percentage of these deferrals and may make additional discretionary contributions. At December 31, 2020 and December 31, 2019, the aggregate value of this DC Plan liability was $9.8 and $8.7 million, respectively, and is included within “accounts payable and other accrued liabilities” and “other long-term liabilities” in the accompanying Consolidated Balance Sheets. (g) Litigation We are involved from time-to-time with various legal matters arising in the ordinary course of business. These claims and legal proceedings are of a nature we believe are normal and incidental to a pharmaceutical business, and may include product liability, intellectual property, employment matters, and other general claims. We may also be subject to derivative lawsuits from time to time. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are assessed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. Although the ultimate resolution of these various matters cannot be determined at this time, we do not believe that such matters, individually or in the aggregate, will have a material adverse effect on our consolidated results of operations, cash flows, or financial condition. Shareholder Litigation Olutayo Ayeni v. Spectrum Pharmaceuticals, Inc., et al. (Filed September 21, 2016 in the United States District Court, Central District of California; Case No. 2:16-cv-07074) (the “Ayeni Action”) and Glen Hartsock v. Spectrum Pharmaceuticals, Inc., et al. (Filed September 28, 2016 in the United States District Court, District Court of Nevada Case; No. 2:16-cv-02279-RFB-GWF) (the “Hartsock Action”). On November 15, 2016, the Ayeni Action was transferred to the United States District Court for the District of Nevada. The parties stipulated to a consolidation of the Ayeni Action with the Hartsock Action. These class action lawsuits allege 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 New Drug Application to the FDA for QAPZOLA 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 July 23, 2019, we entered into a memorandum of understanding with these plaintiffs for a collective settlement pending court approval. Plaintiffs filed an unopposed motion for preliminary approval of the class action settlement on December 27, 2019, which was granted on February 19, 2020. Following notice of the settlement to the class, the Court granted final approval of the class action settlement on July 28, 2020. The settlement amount has been paid, and the Court dismissed the Actions with prejudice on August 12, 2020. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES The components of loss before benefit for income taxes from continuing operations are as follows: Year Ended December 31, 2020 2019 United States $ (173,398) $ (139,682) Foreign 2,066 (4,912) Total $ (171,332) $ (144,594) The benefit for income taxes from continuing operations consist of the following: Year Ended December 31, 2020 2019 Current: Federal $ — $ (6,584) State (76) (1,166) Foreign 16 11 $ (60) $ (7,739) Deferred: Federal — (781) State — (688) — (1,469) Total income tax benefit $ (60) $ (9,208) For the fiscal years ended December 31, 2020 and 2019, we generated losses from continuing operations and recognized income from other financial statement categories such as “income from discontinued operations” and “other comprehensive income (loss)”. Prior to the early adoption of ASU 2019-12, the intraperiod tax allocation guidance required that we allocate income taxes between continuing operations and other categories of earnings. As a result of the required intraperiod allocation, we recognized $9.2 million of tax benefit for our losses from continuing operations during the year ended December 31, 2019. Tax charges recorded within “income from discontinued operations” on the accompanying Consolidated Statements of Operations and other comprehensive income (loss) on the accompanying Statements of Comprehensive Loss substantially offset the tax benefits recognized within “loss from continuing operations” for the year ended December 31, 2019. The intraperiod allocation is not applicable for the year ended December 31, 2020 as a result of the early adoption of ASU 2019-12 . The income tax benefit differs from that computed using the applicable federal statutory rate, as applied to our income before taxes in each year as follows: Year Ended December 31, 2020 2019 Tax provision computed at the federal statutory rate $ (35,980) $ (30,365) State tax, net of federal benefit (5,142) (4,126) Research and development expense tax credits (2,686) (2,526) Change in uncertain tax benefit reserve (27) — Change in tax credit carryforwards 109 81 Officers compensation 2,497 1,506 Stock based compensation 1,619 (230) Permanent items and other (37) 267 Tax differential on foreign earnings (1) (31) Change in tax rate (1,091) 1,126 Refundable alternative minimum tax credit — — Change in prior year deferred taxes (998) 1,170 Valuation allowance 41,677 23,920 Income tax benefit $ (60) $ (9,208) Significant components of our deferred tax assets and liabilities as of December 31, 2020 and 2019 are presented below. A valuation allowance has been recognized to offset the net deferred tax assets as realization of such deferred tax assets did not meet our “more-likely-than-not” assessment threshold, as required under GAAP. December 31, 2020 2019 Deferred tax assets: Net operating loss carry forwards $ 143,045 $ 118,163 Research and development expense tax credits 25,424 22,724 Stock based compensation 4,037 4,385 Lease obligation 599 919 Development costs 487 704 Returns and allowances 1,061 1,069 Amortization differences 1,479 — Depreciation 4,746 — Other, net 17,420 11,861 Total deferred tax assets before valuation allowance 198,298 159,825 Valuation allowance (192,513) (152,966) Total deferred tax assets 5,785 6,859 Deferred tax liabilities, net: Unrealized gains (5,230) (5,607) Depreciation differences — (389) Right-of-use asset (555) (863) Net deferred tax liabilities $ — $ — At December 31, 2020 and 2019, we recorded a valuation allowance of $192.5 million and $153.0 million, respectively. The valuation allowance increased by $39.5 million and $21.9 million during 2020 and 2019, respectively. The increase in the valuation allowance in 2020 was mostly due to an increase in net operating loss carryforwards. We had federal and state net operating loss carryforwards of approximately $600.7 million and $349.7 million, at December 31, 2020, respectively. We have approximately $0.5 million of foreign loss carryforwards that will begin to expire in 2039. The federal and state loss carry forwards began to expire in 2021 unless previously utilized. Federal loss carryforwards generated in 2018 and beyond will be carried forward indefinitely. At December 31, 2020, we had federal and state tax credits of approximately $17.6 million and $10.0 million, respectively. The federal tax credit carryovers begin to expire in 2027 unless previously utilized. The state research and development credit carryforwards have an indefinite carryover period. Our utilization of certain net operating loss and research and development expense tax credit carryforwards, including those acquired in connection with the acquisition of Allos Therapeutics, Inc. in April 2012 and Talon Therapeutics, Inc. in July 2016, are subject to annual limitations under Sections 382 and 383 of the Internal Revenue Code of 1986 and similar state provisions. Any net operating losses or credits that would expire unutilized as a result of Section 382 and 383 limitations have been removed from the table of deferred tax assets and the accompanying disclosures of net operating loss and research and development carryforwards. The following tabular reconciliation summarizes the activity related to our unrecognized tax benefits: Year Ended December 31, 2020 2019 Balance at beginning of year $ 3,473 $ 3,248 Adjustments related to prior year tax positions (689) (392) Increases related to current year tax positions 579 692 Decreases due to expiration of tax statutes (27) (75) Balance at end of year $ 3,336 $ 3,473 We continue to believe that our tax positions meet the “more-likely-than-not” standard and as part of that analysis, we considered the amounts and probabilities from ultimate settlement with the tax authorities. Approximately $0.1 million and $0.1 million of the total unrecognized tax benefits as of December 31, 2020 and 2019, respectively, would reduce our annual effective tax rate if recognized. Additional amounts in the summary rollforward could impact our effective tax rate if we did not maintain a full valuation allowance on our net deferred tax assets. We do not expect our unrecognized tax benefits to change significantly over the next 12 months. With a few exceptions, we are no longer subject to U.S. federal, state and local income tax examinations for years before 2016. Our policy is to recognize interest and/or penalties related to unrecognized tax benefits in income tax expense in the Consolidated Statements of Operations. On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, a $2 trillion relief package comprised of a combination of tax provisions and other stimulus measures. The CARES Act broadly provides entities tax payment relief and significant business incentives and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act, or the Tax Act. The tax relief measures for entities include a five-year net operating loss carry back, increased interest expense deduction limits, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property. The CARES Act also provides other non-income tax benefits, including federal funding for a range of stabilization measures and emergency funding to assist those impacted by the COVID-19 pandemic. Similar legislation is being enacted in other jurisdictions in which the Company operates. ASC Topic 740, Income Taxes, requires the effect of changes in tax law be recognized in the period in which new legislation is enacted. The enactment of the CARES Act and similar legislation in other jurisdictions in which the Company operates is not expected to have a material impact on its consolidated financial position and results of operations as of December 31, 2020. Early Adoption of ASU 2019-12 — Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In March 2020, we elected to early adopt ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 |
Discontinued Operations
Discontinued Operations | 12 Months Ended |
Dec. 31, 2020 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | DISCONTINUED OPERATIONS Overview In March 2019, we completed the Commercial Product Portfolio Transaction. In accordance with applicable GAAP ( ASC 205-20, Presentation of Financial Statements ), the revenue-deriving activities and allocable expenses of our sold commercial operation, connected to the Commercial Product Portfolio, are separately classified as “discontinued” for all periods presented within the accompanying Consolidated Statements of Operations. Consolidated Statements of Operations The following table presents the various elements of “income from discontinued operations, net of income taxes” as reported in the accompanying Consolidated Statements of Operations: Year ended December 31, 2020 2019 Revenues: Product sales, net $ 10,668 $ 22,325 License fees and service revenue — 290 Total revenues $ 10,668 $ 22,615 Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) 88 12,007 Selling, general and administrative 219 5,801 Research and development (43) 2,624 Amortization of intangible assets — 1,248 Restructuring charges - employee severance — 3,858 Total operating costs and expenses $ 264 $ 25,538 Income (loss) from discontinued operations $ 10,404 $ (2,923) Other income (expense): Change in fair value of contingent consideration — (1,478) Gain on sale of Commercial Product Portfolio — 34,568 Total other income (expense) $ — $ 33,090 Income from discontinued operations before income taxes 10,404 30,167 Provision for income taxes from discontinued operations — (7,470) Income from discontinued operations, net of income taxes $ 10,404 $ 22,697 For the year ended December 31, 2018, management identified certain immaterial errors aggregating to $12.0 million that substantially relates to ZEVALIN rebates owed to qualifying Public Health Service (“PHS”) hospitals from 2009 through the first quarter of 2019. On July 3, 2020, pursuant to communications we had with the Health Resources and Services Administration (“HRSA”), we posted a notification on the HRSA website with instructions for PHS customers on how to make claims with the Company for refunds for the additional rebate amounts they may be eligible for, with a six month deadline for any claims. As of the filing date of this Annual Report on Form 10-K, there have been no claims made by customers. Accordingly, we recorded a reduction to government chargebacks liability of $10.8 million, which was recognized within the “Product sales, net” caption of the Consolidated Statements of Operations for discontinued operations. Product sales, net for the year ended December 31, 2019 includes sales from our Commercial Product Portfolio in January and February 2019 (prior to the completion of the Commercial Product Portfolio Transaction) and EVOMELA sales related to our retained supply agreement with CASI for three perpetual out-license agreements related to our former products including ZEVALIN, MARQIBO, and EVOMELA. Corresponding revenue for shipped product has been recognized within discontinued operations “product sales, net”. This arrangement was complete as of December 31, 2019. The pre-tax gain on sale represents the $158.8 million gross proceeds from the Commercial Product Portfolio Transaction less our $121.2 book value of transferred net assets (inclusive of assumed liabilities) to Acrotech on the March 1, 2019 closing date less legal and banker fees aggregating $3.9 million. In the third quarter of 2019, we reduced the gain for a $0.2 million contract cancellation fee associated with our sold commercial operations; this value was deducted from the $4.0 million escrow account (reported as “restricted cash” on the Consolidated Balance Sheet until its release in November 5, 2019). In the fourth quarter of 2019, we increased this gain by $1.1 million to correct for certain inventory that did not contractually transfer to the buyer. The provision for income taxes from discontinued operations represents an allocation of taxes as required under intraperiod allocation guidance. Due to our aggregate net operating loss-carryforwards, no federal or state income tax payments are expected to be made relating to our current year activity, inclusive of the recognized gain on sale of the Commercial Product Portfolio during the year ended December 31, 2019. Consolidated Balance Sheets Accounts receivable derived from our product sales on and prior to February 28, 2019 were not transferred to Acrotech as part of the Commercial Product Portfolio Transaction, nor were our GTN liabilities and trade accounts payable assumed by Acrotech that were associated with our commercial activities on and prior to February 28, 2019. Accordingly, these specific assets and liabilities remain presented within “accounts receivable, net” and “accounts payable and other accrued liabilities” on the accompanying Consolidated Balance Sheets. Consolidated Statement of Cash Flows The following table presents significant non-cash items for our discontinued operations that are included as adjustments in the accompanying Consolidated Statements of Cash Flows: Year ended December 31, 2020 2019 Depreciation and amortization $ — $ 1,263 Stock-based compensation $ — $ 3,404 Change in fair value of contingent consideration $ — $ 1,478 |
Restructuring Costs Related To
Restructuring Costs Related To Sale Of Commercial Product Portfolio | 12 Months Ended |
Dec. 31, 2020 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Costs Related To Sale Of Commercial Product Portfolio | RESTRUCTURING COSTS RELATED TO SALE OF COMMERCIAL PRODUCT PORTFOLIO Employee Severance In March 2019, we completed the Commercial Product Portfolio Transaction and 87 of our employees were (1) terminated March 1, 2019 or (2) given notice of May 31, 2019 termination and asked to provide transition services for the benefit of Acrotech through that date (as provided by a transition services agreement with Acrotech entered contemporaneously with our sale). For the year ended December 31, 2019, we recognized $0.7 million of income for services rendered to Acrotech under this agreement within “other income (expense), net” on our accompanying Consolidated Statements of Operations. The employees in (1) above were entitled to cash severance payments and acceleration of their unvested restricted stock awards and stock options. For the year ended December 31, 2019, we fully recognized the aggregate value of $5.1 million for this severance benefit, of which $3.9 million, $1.0 million, and $0.2 million is included on the accompanying Consolidated Statements of Operations within “income from discontinued operations, net of income taxes”, “selling, general, and administrative” expenses and “research and development” expenses, respectively. The employees in (2) above were also entitled to cash severance payments and acceleration of their unvested restricted stock awards and stock options, on May 31, 2019. The aggregate value of these one-time cash payments and stock-based award accelerations was $0.5 million. Due to then ongoing service requirements of these employees, we amortized this value through expense on a ratable basis beginning March 1, 2019 through May 31, 2019. For the year ended December 31, 2019, we recognized $0.5 million for this severance benefit, which is included within “selling, general, and administrative” expenses on the accompanying Consolidated Statements of Operations, and within “accrued payroll and benefits” and “additional paid-in capital” (for stock-based awards) on the accompanying Consolidated Balance Sheets as of December 31, 2019. Unpaid cash severance for our former employees was $0 and $0.3 million at December 31, 2020 and 2019, respectively, and is recorded within “accrued payroll and benefits” on the accompanying Consolidated Balance Sheets. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)Selected quarterly financial data (unaudited) for the year ended December 31, 2020 and 2019 is presented below: Quarter Ended (Unaudited) March 31, June 30, September 30, December 31, 2020 Revenues $ — $ — $ — $ — Loss from continuing operations before other income (expense) and income taxes $ (30,787) $ (36,490) $ (39,569) $ (62,888) Loss from continuing operations $ (40,617) $ (32,229) $ (48,518) $ (49,908) Loss per common share from continuing operations, basic and diluted $ (0.36) $ (0.29) $ (0.37) $ (0.36) Quarter Ended (Unaudited) March 31, June 30, September 30, December 31, 2019 Revenues $ — $ — $ — $ — Loss from continuing operations before other income (expense) and income taxes $ (37,838) $ (34,212) $ (30,293) $ (38,355) Loss from continuing operations $ (39,846) $ (28,783) $ (26,557) $ (40,200) Loss per common share from continuing operations, basic and diluted $ (0.36) $ (0.26) $ (0.24) $ (0.36) Net loss per basic and diluted shares are computed independently for each of the quarters presented, based on basic and diluted shares outstanding per quarter, and therefore, it may not sum to the value for the full year. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTSDuring January and February 2021, we sold and issued 5,678,893 shares of our common stock for net proceeds of $21.4 million under the April 2019 ATM Agreement |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2020 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts | SCHEDULE II – VALUATION AND QUALIFYING ACCOUNTS Years Ended December 31, 2020 and 2019 Additions ($ in thousands) Description Balance at Additions Charged Deductions (1) Balance at (in thousands) December 31, 2020 Allowance for credit losses $ 43 $ 169 $ — $ — $ 212 December 31, 2019 Allowance for credit losses $ 67 $ (12) $ 43 $ (55) $ 43 (1) Deductions represent the actual write-off of accounts receivable balances. |
Description of Business, Basi_2
Description of Business, Basis of Presentation, and Operating Segment (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Description of Business | Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharmaceutical company, with a primary strategy comprised of acquiring, developing, and commercializing novel and targeted oncology therapies. Our in-house development organization includes clinical development, regulatory, quality and data management. We continue to build out our commercial and marketing capabilities to prepare for the launch of ROLONTIS. We have three drugs in development: • ROLONTIS, a novel long-acting granulocyte colony-stimulating factor (“G-CSF”) for chemotherapy-induced neutropenia, which is under review by the U.S. Food and Drug Administration (the “FDA”). On October 26, 2020, the Company announced that the FDA had deferred action on the Biologics License Application (“BLA”) for ROLONTIS due to the inability to conduct an inspection of our third-party manufacturing facility in South Korea as a result of COVID-19 related travel restrictions. In March 2021, the FDA scheduled the pre-approval inspection of the Hanmi manufacturing facility for May 2021; • Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations. A New Drug Application (“NDA”) based on data from Cohort 2 of ZENITH20, which evaluated previously treated patients with NSCLC with HER2 exon 20 insertion mutation is expected to be filed with the FDA in 2021; and • Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma patients. Our business strategy is the development of our late-stage assets through commercialization and the sourcing of additional assets that are synergistic with our existing portfolio (through purchase acquisitions, in-licensing transactions, or co-development and marketing arrangements). |
Basis of Presentation | Basis of Presentation Principles of Consolidation The accompanying Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and with the rules and regulations of the Securities and Exchange Commission (“SEC”). These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. In May 2019, we dissolved Spectrum Pharma Canada Inc., previously consolidated as a “variable interest entity” (as defined under applicable GAAP). Discontinued Operations - Sale of our Commercial Product Portfolio On March 1, 2019, we completed the sale of our seven then-commercialized drugs, including FUSILEV, KHAPZORY, FOLOTYN, ZEVALIN , |
Operating Segment | Operating SegmentWe operate one reportable operating segment that is focused exclusively on developing (and eventually marketing) oncology and hematology drug products. For the years ended December 31, 2020 and 2019, all of our revenue and operating costs and expenses were solely attributable to these activities (and as applicable, classified as “discontinued” within the accompanying Consolidated Statements of Operations). |
Revenue Recognition | Revenue Recognition On March 1, 2019, we completed the Commercial Product Portfolio Transaction. In accordance with applicable GAAP ( ASC 205-20, Presentation of Financial Statements ), the revenue-deriving activities of our sold commercial operation are separately classified as “discontinued” for all periods presented within the accompanying Consolidated Statements of Operations. Required Elements of Our Revenue Recognition : Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (“Topic 606”) in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements: (1) we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable; (2) we identify the “performance obligations” in the respective contract; (3) we determine the “transaction price” for each performance obligation in the respective contract; (4) we allocate the transaction price to each performance obligation; and (5) we recognize revenue only when we satisfy each performance obligation. These five elements, as applied to each of our revenue categories, are summarized below: (a) Product Sales : We sell our products to pharmaceutical wholesalers/distributors or to our product licensees (i.e., our customers). Our wholesalers/distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration. Our gross product sales (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in reported “product sales, net” that reflects the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and group purchasing organization (“GPO”) administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales. These GTN estimate categories (that comprise our GTN liabilities) are each discussed below: Product Returns Allowances : Our customers are contractually permitted to return certain purchased products within the contractual allowable time before/after its applicable expiration date. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns using our historical return rates. Returned product is typically destroyed since substantially all are due to its imminent expiry and cannot be resold. Government Chargebacks : Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers. Prompt Pay Discounts : Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage. Commercial Rebates : Commercial rebates are based on (i) our estimates of end-user purchases through a GPO, (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us. Medicaid Rebates : Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in our receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment. Distribution, Data, and GPO Administrative Fees : Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products for various commercial services including: contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales. (b) License Fees : Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (i) upfront license fees, (ii) sales royalties, (iii) sales milestone-achievement fees, and (iv) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows: (1) Upfront License Fees: We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer). (2) Royalties : Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt. (3) Sales Milestones : Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt. (4) Regulatory Milestones : Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee. • When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” (i.e., not recognized) until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. • When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. (c) Service Revenue : We receive fees under certain arrangements for (i) sales and marketing services, (ii) supply chain services, (iii) research and development services, and (iv) clinical trial management services. Our rights to receive payment for these services may be established by (1) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (2) our completion of product delivery in our capacity as a procurement agent, (3) the successful completion of a phase of drug development, (4) favorable results from a clinical trial, and/or (5) regulatory approval events. We consider whether revenue associated with these service arrangements is reportable each period, based on our completed services or deliverables (i.e., satisfied “performance obligations”) during the reporting period, and the terms of the arrangement that contractually result in fixed payments due to us. The promised service(s) within these arrangements are distinct and explicitly stated within each contract, and our customer benefits from the separable service(s) delivery/completion. Further, the nature of the promise to our customer as stated within the respective contract is to deliver each named service individually (not a transfer of combined items to which the promised goods or services are inputs), and thus are separable for revenue recognition. |
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 mutual funds, bank CDs, government-related debt securities, and corporate debt securities. Since we classify these investments as “available-for-sale” any (1) realized gains (losses) or (2) unrealized gains (losses) on these securities are respectively recognized in (1) “other income (expense), net” on the accompanying Consolidated Statements of Operations, or (2) depending on the nature of the marketable securities recognized in “accumulated other comprehensive loss” as a separate component of stockholder’s equity on the accompanying Consolidated Statements of Stockholders’ Equity, or in “other income (expense), net” on the accompanying Consolidated Statements of Operations. We classify our equity securities within marketable securities as well, with any gains or losses recorded within “other income (expense), net” within the Consolidated Statements of Operations. |
Accounts Receivable, Net | Accounts Receivable, NetOur accounts receivable, net of allowance for credit losses, are derived from our product sales and license fees, and do not bear interest. The allowance for credit losses is management’s best estimate of the amount of expected credit losses in our existing accounts receivable and any anticipated discounts. The allowance for credit losses is adjusted each period through earnings to reflect expected credit losses over the remaining life of the asset. Account balances are written off against the allowance after appropriate collection efforts are exhausted. In June 2016, the Financial Accounting Standards Board issued ASU No. 2016-13 ("ASU 2016-13") "Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments" , which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. This new ASU replaces the existing incurred loss impairment model with a current expected credit loss model (“CECL”), which requires the use of forward-looking information to calculate credit loss estimates. The new CECL model requires recognition of credit losses for loans and other receivables at the time the financial asset is originated or acquired, in which the expected credit losses are adjusted each period for changes in expected lifetime credit losses. The new standard also applies to receivables arising from revenue transactions such as contract assets and accounts receivables and requires credit losses related to certain available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. We adopted ASU 2016-13 as of January 1, 2020, which did not have a material effect on our accompany Consolidated Financial Statements. |
Inventories | Inventories We value our inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its net realizable value, which takes into account our sales forecast by product and corresponding expiry dates of each product lot. Manufacturing costs of drug products that are pending FDA approval during clinical development and trials, and at-risk inventory build in anticipation of commercialization, are exclusively recognized through “research and development” expense on the accompanying Consolidated Statements of Operations. |
Property and Equipment, Net | Property and Equipment, Net Our property and equipment, net, is stated at historical cost, and is depreciated on a straight-line basis over an estimated useful life that corresponds with its designated asset category. We evaluate the recoverability of long-lived assets (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable. Recoverability is measured by a comparison of the carrying amount to the net undiscounted cash flows expected to be generated by the asset group. An impairment loss would be recorded for the excess of net carrying value over the fair value of the asset impaired. The fair value is estimated based on expected discounted future cash flows or other methods such as orderly liquidation value based on assumptions of asset class and observed market data. An orderly liquidation value is the amount that could be realized upon liquidation, given a sufficient amount of time to find a purchaser for a sale of assets in their existing condition and location, as of a specific date, and assuming the sale is to market participants who can utilize such assets in their highest and best use. The orderly liquidation values are applied against the carrying values of the assets and the impairment loss is measured as the difference between the liquidation value and the carrying value of the assets. See Note 4(d) for further discussion about an impairment that occurred during the fourth quarter of 2020. In August 2018, the FASB issued Accounting Standards Update No. 2018-15, Intangibles – Goodwill and other – Internal-Use Software (Subtopic 350-40), which amended its guidance for costs of implementing a cloud computing service arrangement and aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software, and to expense such capitalized implementation costs over the term of the hosting arrangement. The guidance is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. On January 1, 2021, we adopted this standard on a prospective basis for applicable implementation costs, which did not have a material impact on our consolidated financial statements. |
Stock-Based Compensation | Stock-Based CompensationStock-based compensation expense for equity awards granted to our employees and members of our Board of Directors is recognized on a straight-line basis over each award’s vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited prior to vesting, though is ultimately adjusted for actual forfeitures. We use the Black-Scholes option pricing model to determine the fair value of stock options and stock appreciation rights (as of the date of grant) that have service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) that have combined market conditions and service conditions for vesting. The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term that the stock option will remain outstanding, (c) our stock price volatility over the expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the prevailing risk-free interest rate for the period matching the expected term. With regard to (a)-(d) above: we estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on the historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option. |
Basic and Diluted Net Loss per Share | Basic and Diluted Net Loss per ShareWe calculate basic and diluted net loss per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. We have recorded a valuation allowance to reduce our deferred tax assets, 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 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 its external service providers. We adjust our accruals as actual costs become known. Where contingent milestone payments are due to third parties under research and development or license agreements, the milestone payment obligations are expensed when the clinical or regulatory milestone results are achieved. |
Fair Value Measurements | Fair Value MeasurementsWe determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. Level 3: Unobservable inputs are used when little or no market data is available. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Summary of Asset and Liability Fair Values | The table below summarizes certain asset and liability fair values that are included within our accompanying Consolidated Balance Sheets, and their designations among the three fair value measurement categories: December 31, 2020 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 40,560 $ — $ — $ 40,560 Equity securities 24,946 — — 24,946 Government-related debt securities 92,928 — — 92,928 Corporate debt securities — 8,848 — 8,848 Mutual funds 5,573 9 — 5,582 Bank CDs — 1,721 — 1,721 Key employee life insurance, cash surrender value (1) — 3,963 — 3,963 $ 164,007 $ 14,541 $ — $ 178,548 Liabilities: Deferred executive compensation liability (2) $ — $ 9,783 $ — $ 9,783 $ — $ 9,783 $ — $ 9,783 (1) Included within other assets on our Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $1.3 million within accounts payable and other accrued liabilities and $8.5 million within other long-term liabilities on our Consolidated Balance Sheets. The amounts are based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 54,199 $ — $ — $ 54,199 Equity securities 31,047 — — 31,047 Government-related debt securities 47,636 14,990 — 62,626 Corporate debt securities — 58,248 — 58,248 Mutual funds 5,158 11 — 5,169 Bank CDs — 7,376 — 7,376 Key employee life insurance, cash surrender value (1) — 3,547 — 3,547 $ 138,040 $ 84,172 $ — $ 222,212 Liabilities: Deferred executive compensation liability (2) $ — $ 8,746 $ — $ 8,746 $ — $ 8,746 $ — $ 8,746 (1) Included within other assets on our Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $0.1 million within accounts payable and other accrued liabilities and $8.6 million within other long-term liabilities on our Consolidated Balance Sheets. The amounts are based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. |
Balance Sheet Account Detail (T
Balance Sheet Account Detail (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Cash and Cash Equivalents and Marketable Securities | The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Foreign Currency Translation Unrealized Unrealized Losses Fair Value Cash and Cash Marketable Securities December 31, 2020 Money market funds $ 40,560 $ — $ — $ — $ 40,560 $ 40,560 $ — Equity securities (1) 3,764 (1,546) 22,728 — 24,946 — 24,946 Government-related debt securities 92,881 — 47 — 92,928 — 92,928 Corporate debt securities 8,846 — 2 — 8,848 — 8,848 Mutual funds 4,497 — 1,076 — 5,573 — 5,573 Bank CDs 1,715 — 6 — 1,721 — 1,721 Bank deposits 5,449 — — — 5,449 5,449 — Total cash and cash equivalents and marketable securities $ 157,712 $ (1,546) $ 23,859 $ — $ 180,025 $ 46,009 $ 134,016 December 31, 2019 Money market funds $ 54,199 $ — $ — $ — $ 54,199 $ 54,199 $ — Equity securities 6,310 (2,477) 27,214 — 31,047 — 31,047 Government-related debt securities 62,617 — 19 (10) 62,626 — 62,626 Corporate debt securities 58,235 — 38 (25) 58,248 5,000 53,248 Mutual funds 4,375 — 783 — 5,158 — 5,158 Bank CDs 7,354 — 22 — 7,376 — 7,376 Bank deposits 5,219 — — — 5,219 5,219 — Total cash and cash equivalents and marketable securities $ 198,309 $ (2,477) $ 28,076 $ (35) $ 223,873 $ 64,418 $ 159,455 (1) Our aggregate equity holdings consist of 8.5 million common shares of CASI, a publicly-traded biopharmaceutical company (NASDAQ: CASI) as of December 31, 2020 represented less than 10.0% ownership with a fair market value of 24.9 million. During 2020, we completed the sale of 1.6 million common shares and recognized a $1.4 million gain within “other expense, net” within the accompanying Consolidated Statements of Operations for the year ended December 31, 2020. |
Schedule of Other Receivables | “Other receivables” consists of the following: December 31, 2020 2019 Insurance receivable 5 4,015 CASI receivables — 2,393 Other miscellaneous receivables 896 1,490 Income tax receivable - current portion 1,297 973 Interest receivable from marketable securities 196 561 Reimbursements for incurred research and development expenses — 126 Other receivables $ 2,394 $ 9,558 |
Schedule of Prepaid Expenses and Other Assets | “Prepaid expenses and other current assets” consists of the following: December 31, 2020 2019 Vendor deposits (1) 1,996 8,740 Prepaid insurance $ 2,165 $ 1,408 Prepaid expenses and other current assets $ 4,161 $ 10,148 (1) The decrease in vendor deposits relates to $8.5 million of cancelled manufacturing work at our second source contract manufacturer for ROLONTIS. See Note 4(d) for further discussion. |
Schedule of Property and Equipment, net | “Property and equipment, net” consists of the following: December 31, 2020 2019 Manufacturing equipment $ 3,245 $ 10,355 Computer hardware and software 1,680 3,606 Laboratory equipment 5 36 Office furniture 248 248 Leasehold improvements 1,267 3,374 Property and equipment, at cost 6,445 17,619 (Less): Accumulated depreciation (2,868) (6,012) Property and equipment, net $ 3,577 $ 11,607 |
Schedule of Accounts Payable and Other Accrued Liabilities | “Accounts payable and other accrued liabilities” consists of the following: December 31, 2020 2019 Trade accounts payable and other $ 34,385 $ 32,012 Lease liability - current portion 1,544 1,683 Accrued commercial/Medicaid rebates 1,624 2,925 Accrued product royalty due to licensors — 66 Allowance for product returns 4,299 4,714 Accrued data and distribution fees 768 768 Accrued GPO administrative fees 6 6 Accrued inventory management fees 168 364 Allowance for government chargebacks 977 11,746 Accounts payable and other accrued liabilities $ 43,771 $ 54,284 |
Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities | Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Consolidated Balance Sheets for our categories of GTN estimates were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, Product Return Allowances Balance as of December 31, 2018 $ 22,952 $ 3,932 $ 5,171 Add: GTN accruals recorded for product sales 7,702 1,209 167 (Less): Payments made and credits against GTN accruals (15,983) (4,003) (624) Balance as of December 31, 2019 14,671 1,138 4,714 Add: GTN accruals recorded for product sales — — — (Less): Payments made and credits against GTN accruals (see Note 9 ) (12,070) (196) (415) Balance as of December 31, 2020 $ 2,601 $ 942 $ 4,299 . |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock-Based Compensation Expense | We report our stock-based compensation expense (inclusive of our incentive stock plan, employee stock purchase plan, and 401(k) contribution matching program) in the accompanying Consolidated Statements of Operations within “total operating costs and expenses” for the years ended December 31, 2020 and 2019, as follows: Year Ended December 31, 2020 2019 Selling, general and administrative $ 13,127 $ 14,118 Research and development 4,692 4,316 Total stock-based compensation $ 17,819 $ 18,434 |
Fair Value of Stock Options Granted Using Black-Scholes Option Pricing Model | The fair value of stock options granted was estimated at the date of grant using the Black-Scholes option-pricing model. The following assumptions were used to determine fair value for the stock awards granted in the applicable year: Year Ended December 31, 2020 2019 Expected option life (in years) (a) 5.46 5.34 Risk-free interest rate (b) 0.34% - 1.61% 1.47% - 2.49% Volatility (c) 74.5% - 81.4% 61.6% - 76.1% Dividend yield (d) 0% 0% Weighted-average grant-date fair value per stock option $1.63 $5.85 (a) Determined by the historical stock option exercise behavior of our employees (maximum term is 10 years). (b) Based upon the U.S. Treasury yields in effect during the period which the options were granted (for a period equaling the stock options’ expected term). (c) Measured using our historical stock price for a period equal to stock options’ expected term. (d) We do not expect to declare any cash dividends in the foreseeable future. |
Summary of Stock Option Activity | Stock option activity during the years ended December 31, 2020 and 2019 was as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2018 6,843,585 $ 8.98 Granted 1,113,081 10.54 Exercised (1,121,403) 6.38 $ 2,919 (1) Forfeited (172,074) 9.84 Expired (223,253) 11.09 Outstanding — December 31, 2019 6,439,936 9.61 Granted 2,032,000 2.34 Exercised (3,542) 3.70 $ 708 (1) Forfeited (170,187) 8.29 Expired (641,584) 8.55 Outstanding — December 31, 2020 7,656,623 $ 7.80 6.33 $ 2,184 (2) Vested (exercisable) — December 31, 2020 5,221,749 $ 8.65 5.19 $ 503 (2) Unvested (unexercisable) — December 31, 2020 2,434,874 $ 5.98 8.75 $ 1,397 (2) (1) Represents the total difference between our closing stock price at the time of exercise and the stock option exercise price, multiplied by the number of options exercised. (2) Represents the total difference between our closing stock price on the last trading day of 2020 and the stock option exercise price, multiplied by the number of in-the-money options as of December 31, 2020. The amount of intrinsic value will change based on the fair market value of our stock. |
Summary of Stock Option Grants | The following table summarizes information with respect to stock option grants as of December 31, 2020: Outstanding Exercisable Exercise Price Granted Stock Weighted- Weighted- Granted Weighted- $1.47 - 4.96 2,004,807 9.2 $ 2.36 426,557 $ 2.30 $4.97 - 6.91 1,953,056 5.33 6.00 1,899,501 6.00 $6.92 - 9.00 1,628,613 3.88 7.86 1,482,404 7.81 $9.01 - 12.00 968,289 6.59 11.15 566,565 11.02 $12.01 - 22.64 1,101,858 6.26 17.89 846,722 17.70 7,656,623 6.33 $ 7.80 5,221,749 $ 8.65 |
Summary of Restricted Stock Award and Restricted Stock Units Activity | A summary of restricted stock award activity is as follows: Number of Weighted Average Unvested — December 31, 2018 1,802,130 $ 12.75 Granted 1,091,353 10.50 Vested (972,404) 11.70 Forfeited (261,320) 11.48 Unvested — December 31, 2019 1,659,759 11.67 Granted 4,026,518 2.68 Vested (753,475) 11.23 Forfeited (436,757) 6.03 Unvested — December 31, 2020 4,496,045 $ 4.29 Number of Weighted Average Outstanding — December 31, 2018 255,214 $ 17.91 Granted 257,585 12.87 Market-based achievement adjustment at vesting 116,880 6.49 Share issuance (243,760) 7.04 Outstanding — December 31, 2019 385,919 18.00 Granted 6,800 2.36 Market-based achievement adjustment at vesting (128,334) — Share issuance (861) 10.69 Outstanding — December 31, 2020 263,524 $ 26.39 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Schedule of Stock by Class | We sold and issued common shares under the April 2019 ATM Agreement as follows: Description of Financing Transaction No. of Common Shares Issued Proceeds Received (Net of Broker Commissions and Fees ) Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2019 221,529 $ 1,814 Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2020 3,950,398 $ 14,902 |
Financial Commitments & Conti_2
Financial Commitments & Contingencies and Key License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Lease Assets and Liabilities | The below table summarizes these lease asset and liability accounts presented on our accompanying Consolidated Balance Sheets: Operating Leases Consolidated Balance Sheet Caption December 31, 2020 December 31, 2019 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 2,247 $ 3,806 Operating lease liabilities - current Accounts payable and other accrued liabilities $ 1,544 $ 1,683 Operating lease liabilities - non-current Other long-term liabilities 883 2,372 Total lease liabilities $ 2,427 $ 4,055 |
Components of Aggregate Lease Expense | The components of our aggregate lease expense is summarized below: Year Ended December 31, 2020 Year Ended December 31, 2019 Operating lease cost $ 1,865 $ 1,660 Variable lease cost 411 470 Short-term lease cost 61 77 Total lease cost $ 2,337 $ 2,207 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of December 31, 2020 1.6 years 7.8% Operating leases as of December 31, 2019 2.5 years 7.8% |
Future Contractual Lease Payments | he below table summarizes our (i) minimum lease payments over the next five years, (ii) lease arrangement implied interest, and (iii) present value of future lease payments: Operating Leases - future payments December 31, 2020 2021 $ 1,670 2022 828 2023 87 2024 — 2025 — Total future lease payments, undiscounted $ 2,585 (Less): Implied interest (158) Present value of operating lease payments $ 2,427 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Components of Loss before Benefit for Income Taxes | The components of loss before benefit for income taxes from continuing operations are as follows: Year Ended December 31, 2020 2019 United States $ (173,398) $ (139,682) Foreign 2,066 (4,912) Total $ (171,332) $ (144,594) |
Benefit from Income Taxes | The benefit for income taxes from continuing operations consist of the following: Year Ended December 31, 2020 2019 Current: Federal $ — $ (6,584) State (76) (1,166) Foreign 16 11 $ (60) $ (7,739) Deferred: Federal — (781) State — (688) — (1,469) Total income tax benefit $ (60) $ (9,208) |
Income Tax Benefit Differs from Computed Using Federal Statutory Rate Applied to Income before Taxes | The income tax benefit differs from that computed using the applicable federal statutory rate, as applied to our income before taxes in each year as follows: Year Ended December 31, 2020 2019 Tax provision computed at the federal statutory rate $ (35,980) $ (30,365) State tax, net of federal benefit (5,142) (4,126) Research and development expense tax credits (2,686) (2,526) Change in uncertain tax benefit reserve (27) — Change in tax credit carryforwards 109 81 Officers compensation 2,497 1,506 Stock based compensation 1,619 (230) Permanent items and other (37) 267 Tax differential on foreign earnings (1) (31) Change in tax rate (1,091) 1,126 Refundable alternative minimum tax credit — — Change in prior year deferred taxes (998) 1,170 Valuation allowance 41,677 23,920 Income tax benefit $ (60) $ (9,208) |
Components of Company's Deferred Tax Assets | Significant components of our deferred tax assets and liabilities as of December 31, 2020 and 2019 are presented below. A valuation allowance has been recognized to offset the net deferred tax assets as realization of such deferred tax assets did not meet our “more-likely-than-not” assessment threshold, as required under GAAP. December 31, 2020 2019 Deferred tax assets: Net operating loss carry forwards $ 143,045 $ 118,163 Research and development expense tax credits 25,424 22,724 Stock based compensation 4,037 4,385 Lease obligation 599 919 Development costs 487 704 Returns and allowances 1,061 1,069 Amortization differences 1,479 — Depreciation 4,746 — Other, net 17,420 11,861 Total deferred tax assets before valuation allowance 198,298 159,825 Valuation allowance (192,513) (152,966) Total deferred tax assets 5,785 6,859 Deferred tax liabilities, net: Unrealized gains (5,230) (5,607) Depreciation differences — (389) Right-of-use asset (555) (863) Net deferred tax liabilities $ — $ — |
Summary of Unrecognized Tax Benefits | The following tabular reconciliation summarizes the activity related to our unrecognized tax benefits: Year Ended December 31, 2020 2019 Balance at beginning of year $ 3,473 $ 3,248 Adjustments related to prior year tax positions (689) (392) Increases related to current year tax positions 579 692 Decreases due to expiration of tax statutes (27) (75) Balance at end of year $ 3,336 $ 3,473 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Condensed Consolidated Statements of Operations and Cash Flows | The following table presents the various elements of “income from discontinued operations, net of income taxes” as reported in the accompanying Consolidated Statements of Operations: Year ended December 31, 2020 2019 Revenues: Product sales, net $ 10,668 $ 22,325 License fees and service revenue — 290 Total revenues $ 10,668 $ 22,615 Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) 88 12,007 Selling, general and administrative 219 5,801 Research and development (43) 2,624 Amortization of intangible assets — 1,248 Restructuring charges - employee severance — 3,858 Total operating costs and expenses $ 264 $ 25,538 Income (loss) from discontinued operations $ 10,404 $ (2,923) Other income (expense): Change in fair value of contingent consideration — (1,478) Gain on sale of Commercial Product Portfolio — 34,568 Total other income (expense) $ — $ 33,090 Income from discontinued operations before income taxes 10,404 30,167 Provision for income taxes from discontinued operations — (7,470) Income from discontinued operations, net of income taxes $ 10,404 $ 22,697 The following table presents significant non-cash items for our discontinued operations that are included as adjustments in the accompanying Consolidated Statements of Cash Flows: Year ended December 31, 2020 2019 Depreciation and amortization $ — $ 1,263 Stock-based compensation $ — $ 3,404 Change in fair value of contingent consideration $ — $ 1,478 |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Selected Quarterly Financial Data | Selected quarterly financial data (unaudited) for the year ended December 31, 2020 and 2019 is presented below: Quarter Ended (Unaudited) March 31, June 30, September 30, December 31, 2020 Revenues $ — $ — $ — $ — Loss from continuing operations before other income (expense) and income taxes $ (30,787) $ (36,490) $ (39,569) $ (62,888) Loss from continuing operations $ (40,617) $ (32,229) $ (48,518) $ (49,908) Loss per common share from continuing operations, basic and diluted $ (0.36) $ (0.29) $ (0.37) $ (0.36) Quarter Ended (Unaudited) March 31, June 30, September 30, December 31, 2019 Revenues $ — $ — $ — $ — Loss from continuing operations before other income (expense) and income taxes $ (37,838) $ (34,212) $ (30,293) $ (38,355) Loss from continuing operations $ (39,846) $ (28,783) $ (26,557) $ (40,200) Loss per common share from continuing operations, basic and diluted $ (0.36) $ (0.26) $ (0.24) $ (0.36) |
Description of Business, Basi_3
Description of Business, Basis of Presentation, and Operating Segment - Additional Information (Details) $ in Millions | Mar. 01, 2019USD ($)product | Dec. 31, 2020productSegment |
Segment Reporting Information [Line Items] | ||
Number of late stage development drugs | product | 3 | |
Number of reportable operating segment | Segment | 1 | |
Early Adoption of ASU 2019-12 | Early Adoption of ASU 2019-12 — Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In March 2020, we elected to early adopt ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 | |
Sale | Commercial Product Portfolio | ||
Segment Reporting Information [Line Items] | ||
Number of products | product | 7 | |
Upfront payment expected to be received | $ 158.8 | |
Aggregate amount receivable based on achievement of milestones | 140 | |
Payment receivable on achievement of regulatory milestones | 40 | |
Potential payments based on achievement of sales milestones | $ 100 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Asset and Liability Fair Values (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets: | ||
Equity securities | $ 24,946 | $ 31,047 |
Key employee life insurance, cash surrender value | 3,963 | 3,547 |
Total Assets | 178,548 | 222,212 |
Liabilities: | ||
Deferred executive compensation liability | 9,783 | 8,746 |
Total Liabilities | 9,783 | 8,746 |
Money market funds | ||
Assets: | ||
Available-for-sale | 40,560 | 54,199 |
Government-related debt securities | ||
Assets: | ||
Available-for-sale | 92,928 | 62,626 |
Corporate debt securities | ||
Assets: | ||
Available-for-sale | 8,848 | 58,248 |
Mutual funds | ||
Assets: | ||
Available-for-sale | 5,582 | 5,169 |
Bank CDs | ||
Assets: | ||
Available-for-sale | 1,721 | 7,376 |
Level 1 | ||
Assets: | ||
Equity securities | 24,946 | 31,047 |
Key employee life insurance, cash surrender value | 0 | 0 |
Total Assets | 164,007 | 138,040 |
Liabilities: | ||
Deferred executive compensation liability | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 1 | Money market funds | ||
Assets: | ||
Available-for-sale | 40,560 | 54,199 |
Level 1 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 92,928 | 47,636 |
Level 1 | Corporate debt securities | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 1 | Mutual funds | ||
Assets: | ||
Available-for-sale | 5,573 | 5,158 |
Level 1 | Bank CDs | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 2 | ||
Assets: | ||
Equity securities | 0 | 0 |
Key employee life insurance, cash surrender value | 3,963 | 3,547 |
Total Assets | 14,541 | 84,172 |
Liabilities: | ||
Deferred executive compensation liability | 9,783 | 8,746 |
Total Liabilities | 9,783 | 8,746 |
Level 2 | Accounts Payable and Accrued Liabilities | ||
Liabilities: | ||
Deferred executive compensation liability | 1,300 | 100 |
Level 2 | Other Noncurrent Liabilities | ||
Liabilities: | ||
Deferred executive compensation liability | 8,500 | 8,600 |
Level 2 | Money market funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 2 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 0 | 14,990 |
Level 2 | Corporate debt securities | ||
Assets: | ||
Available-for-sale | 8,848 | 58,248 |
Level 2 | Mutual funds | ||
Assets: | ||
Available-for-sale | 9 | 11 |
Level 2 | Bank CDs | ||
Assets: | ||
Available-for-sale | 1,721 | 7,376 |
Level 3 | ||
Assets: | ||
Equity securities | 0 | 0 |
Key employee life insurance, cash surrender value | 0 | 0 |
Total Assets | 0 | 0 |
Liabilities: | ||
Deferred executive compensation liability | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 3 | Money market funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 | Corporate debt securities | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 | Mutual funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 | Bank CDs | ||
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 | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | $ 3,764 | $ 6,310 |
Foreign Currency Translation | (1,546) | (2,477) |
Unrealized Gains | 22,728 | 27,214 |
Unrealized Losses | 0 | 0 |
Equity securities | 24,946 | 31,047 |
Historical or Amortized Cost | 157,712 | 198,309 |
Unrealized Gains | 23,859 | 28,076 |
Unrealized Losses | 0 | (35) |
Cash, cash equivalents, and short-term investments | 180,025 | 223,873 |
Level 1 | ||
Schedule of Investments [Line Items] | ||
Equity securities | $ 24,946 | 31,047 |
CASI Common Stock | ||
Schedule of Investments [Line Items] | ||
Number of shares held in investment (in shares) | 8.5 | |
Percentage of ownership (less than) | 10.00% | |
Number of common shares sale in investments (in shares) | 1.6 | |
Realized gain on equity securities | $ 1,400 | |
CASI Common Stock | Level 1 | ||
Schedule of Investments [Line Items] | ||
Equity securities | 24,900 | |
Cash and Cash equivalents | ||
Schedule of Investments [Line Items] | ||
Equity securities | 0 | 0 |
Cash, cash equivalents, and short-term investments | 46,009 | 64,418 |
Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Equity securities | 24,946 | 31,047 |
Cash, cash equivalents, and short-term investments | 134,016 | 159,455 |
Money market funds | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 40,560 | 54,199 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Available-for-sale | 40,560 | 54,199 |
Money market funds | Cash and Cash equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 40,560 | 54,199 |
Money market funds | Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 0 | 0 |
Government-related debt securities | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 92,881 | 62,617 |
Unrealized Gains | 47 | 19 |
Unrealized Losses | 0 | (10) |
Available-for-sale | 92,928 | 62,626 |
Government-related debt securities | Cash and Cash equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 0 | 0 |
Government-related debt securities | Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 92,928 | 62,626 |
Corporate debt securities | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 8,846 | 58,235 |
Unrealized Gains | 2 | 38 |
Unrealized Losses | 0 | (25) |
Available-for-sale | 8,848 | 58,248 |
Corporate debt securities | Cash and Cash equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 0 | 5,000 |
Corporate debt securities | Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 8,848 | 53,248 |
Mutual funds | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 4,497 | 4,375 |
Unrealized Gains | 1,076 | 783 |
Unrealized Losses | 0 | 0 |
Available-for-sale | 5,573 | 5,158 |
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 | 5,573 | 5,158 |
Bank CDs | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 1,715 | 7,354 |
Unrealized Gains | 6 | 22 |
Unrealized Losses | 0 | 0 |
Available-for-sale | 1,721 | 7,376 |
Bank CDs | Cash and Cash equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 0 | 0 |
Bank CDs | Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 1,721 | 7,376 |
Bank deposits | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 5,449 | 5,219 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Available-for-sale | 5,449 | 5,219 |
Bank deposits | Cash and Cash equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 5,449 | 5,219 |
Bank deposits | Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | $ 0 | $ 0 |
Balance Sheet Account Detail _2
Balance Sheet Account Detail - Schedule of Other Receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Insurance receivable | $ 5 | $ 4,015 |
CASI receivables | 0 | 2,393 |
Other miscellaneous receivables | 896 | 1,490 |
Income tax receivable - current portion | 1,297 | 973 |
Interest receivable from marketable securities | 196 | 561 |
Reimbursements for incurred research and development expenses | 0 | 126 |
Other receivables | $ 2,394 | $ 9,558 |
Balance Sheet Account Detail _3
Balance Sheet Account Detail - Prepaid Expenses and Other Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Vendor deposits | $ 1,996 | $ 8,740 |
Prepaid insurance | 2,165 | 1,408 |
Prepaid expenses and other current assets | 4,161 | $ 10,148 |
Write off of vendor deposits | $ 8,500 |
Balance Sheet Account Detail _4
Balance Sheet Account Detail - Schedule of Property and Equipment Net of Accumulated Depreciation (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | |||
Property and equipment, at cost | $ 6,445 | $ 6,445 | $ 17,619 |
(Less): Accumulated depreciation | (2,868) | (2,868) | (6,012) |
Property and equipment, net | 3,577 | 3,577 | 11,607 |
Depreciation expense | 300 | 400 | |
Impairment of second source manufacturer | 19,700 | ||
Write off of prepaid costs | 8,500 | ||
Manufacturing equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, at cost | 3,245 | 3,245 | 10,355 |
Computer hardware and software | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, at cost | 1,680 | 1,680 | 3,606 |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, at cost | 5 | 5 | 36 |
Office furniture | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, at cost | 248 | 248 | 248 |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, at cost | $ 1,267 | $ 1,267 | $ 3,374 |
Balance Sheet Account Detail _5
Balance Sheet Account Detail - Schedule of Accounts Payable and Other Accrued Obligations (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other | $ 34,385 | $ 32,012 |
Lease liability - current portion | 1,544 | 1,683 |
Accrued commercial/Medicaid rebates | 1,624 | 2,925 |
Accrued product royalty due to licensors | 0 | 66 |
Allowance for product returns | 4,299 | 4,714 |
Accrued data and distribution fees | 768 | 768 |
Accrued GPO administrative fees | 6 | 6 |
Accrued inventory management fees | 168 | 364 |
Allowance for government chargebacks | 977 | 11,746 |
Accounts payable and other accrued liabilities | $ 43,771 | $ 54,284 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accounts payable and other accrued liabilities | Accounts payable and other accrued liabilities |
Balance Sheet Account Detail _6
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Obligations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Commercial/Medicaid Rebates and Government Chargebacks | ||
Accounts Payable And Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | $ 14,671 | $ 22,952 |
Add: GTN accruals recorded for product sales | 0 | 7,702 |
(Less): Payments made and credits against GTN accruals (see Note 9) | (12,070) | (15,983) |
Ending balance | 2,601 | 14,671 |
Distribution, Data, Inventory, and GPO Administrative Fees | ||
Accounts Payable And Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | 1,138 | 3,932 |
Add: GTN accruals recorded for product sales | 0 | 1,209 |
(Less): Payments made and credits against GTN accruals (see Note 9) | (196) | (4,003) |
Ending balance | 942 | 1,138 |
Product Return Allowances | ||
Accounts Payable And Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | 4,714 | 5,171 |
Add: GTN accruals recorded for product sales | 0 | 167 |
(Less): Payments made and credits against GTN accruals (see Note 9) | (415) | (624) |
Ending balance | $ 4,299 | $ 4,714 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2020USD ($)planshares | Dec. 31, 2019USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of stock incentive plans | plan | 1 | |
Vesting period | 3 years | |
Estimated forfeiture rate | 15.00% | 16.00% |
Forfeited (in shares) | 170,187 | 172,074 |
Total stock-based compensation | $ | $ 17,819,000 | $ 18,434,000 |
Vesting percent year one | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock based award vest | 33.333% | |
Vesting percent year two | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock based award vest | 33.333% | |
Vesting percent year three | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock based award vest | 33.333% | |
401(k) Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock issued (in shares) | 96,959 | 225,780 |
Stock-based compensation expense | $ | $ 300,000 | $ 1,300,000 |
Exercise of Issued Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense | $ | $ 4,600,000 | |
Weighted average period to recognize compensation expense | 1 year 9 months 18 days | |
Restricted Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Restricted stock or unit expense | $ | $ 9,400,000 | $ 9,200,000 |
Granted (in shares) | 4,026,518 | 1,091,353 |
Restricted Stock Awards | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares available (in percent) | 1.5 | |
Unrecognized compensation expense | $ | $ 12,300,000 | |
Weighted average period to recognize compensation expense | 1 year 10 months 24 days | |
Restricted Stock Units (RSUs) | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares available (in percent) | 1.5 | |
Restricted stock or unit expense | $ | $ 1,100,000 | $ 3,000,000 |
Unrecognized compensation expense | $ | $ 1,100,000 | |
Weighted average period to recognize compensation expense | 1 year | |
Granted (in shares) | 6,800 | 257,585 |
Stock Appreciation Rights (SARs) | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock based award vest | 25.00% | 25.00% |
Unrecognized compensation expense | $ | $ 1,100,000 | |
Weighted average period to recognize compensation expense | 2 years 3 months 18 days | |
Granted (in shares) | 1,650,000 | |
Forfeited (in shares) | 0 | |
Total stock-based compensation | $ | $ 1,500,000 | $ 0 |
Two Thousand Eighteen Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock authorized for issuance under incentive plan (in shares) | 18,000,000 | |
Number of additional shares available (in percent) | 0.01 | |
Exercise price fair value | 100.00% | |
Two Thousand Eighteen Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term of award | 10 | |
Exercise price fair value | 110.00% | |
Two Thousand Eighteen Plan | Exercise of Issued Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Incentive awards available for grant (in shares) | 8,200,000 | |
Two Thousand Eighteen Plan | Restricted Stock Awards | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Incentive awards available for grant (in shares) | 5,500,000 | |
Two Thousand Nine Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares available (in percent) | 0.01 | |
Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock authorized for issuance under incentive plan (in shares) | 8,500,000 | |
Incentive awards available for grant (in shares) | 10,000,000 | |
Percentage of common stock purchase price | 15.00% | |
Maximum number of common stock shares available for purchase per participant (in shares) | 50,000 | |
Purchase plan offering period | 6 months | |
Maximum number of common stock value available for purchase per participant | $ | $ 25,000 | |
Increase in number of shares of common stock available for issuance under the purchase plan (in shares) | 1,000,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 17,819 | $ 18,434 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | 13,127 | 14,118 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 4,692 | $ 4,316 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Granted Using Black-Scholes Option Pricing Model (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected option life (in years) | 5 years 5 months 15 days | 5 years 4 months 2 days |
Risk-free interest rate, Minimum | 0.34% | 1.47% |
Risk-free interest rate, Maximum | 1.61% | 2.49% |
Volatility, Minimum | 74.50% | 61.60% |
Volatility, Maximum | 81.40% | 76.10% |
Dividend yield | 0.00% | 0.00% |
Weighted-average grant-date fair value per stock option (in dollars per share) | $ 1.63 | $ 5.85 |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected option life (in years) | 10 years | 10 years |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares | ||
Outstanding, beginning (in shares) | 6,439,936 | 6,843,585 |
Granted (in shares) | 2,032,000 | 1,113,081 |
Exercised (in shares) | (3,542) | (1,121,403) |
Forfeited (in shares) | (170,187) | (172,074) |
Expired (in shares) | (641,584) | (223,253) |
Outstanding, ending (in shares) | 7,656,623 | 6,439,936 |
Vested (exercisable) (in shares) | 5,221,749 | |
Unvested (unexercisable) (in shares) | 2,434,874 | |
Weighted- Average Exercise Price/Share | ||
Outstanding, beginning (in dollars per share) | $ 9.61 | $ 8.98 |
Granted (in dollars per share) | 2.34 | 10.54 |
Exercised (in dollars per share) | 3.70 | 6.38 |
Forfeited (in dollars per share) | 8.29 | 9.84 |
Expired (in dollars per share) | 8.55 | 11.09 |
Outstanding, ending (in dollars per share) | 7.80 | $ 9.61 |
Vested (exercisable) (in dollars per share) | 8.65 | |
Unvested (unexercisable) (in dollars per share) | $ 5.98 | |
Weighted-Average Remaining Contractual Term (in years), outstanding | 6 years 3 months 29 days | |
Weighted-Average Remaining Contractual Term (in years), vested (exercisable) | 5 years 2 months 8 days | |
Weighted-Average Remaining Contractual Term (in years), unvested (unexercisable) | 8 years 9 months | |
Exercised, Aggregate Intrinsic Value | $ 708 | $ 2,919 |
Outstanding, Aggregate Intrinsic Value | 2,184 | |
Aggregate Intrinsic Value, vested (exercisable) | 503 | |
Aggregate Intrinsic Value, unvested (unexercisable) | $ 1,397 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Grants (Details) | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Granted Stock Options Outstanding (in shares) | shares | 7,656,623 |
Weighted- Average Remaining Contractual Life (in years) | 6 years 3 months 29 days |
Weighted-Average Exercise Price (in dollars per share) | $ 7.80 |
Granted Stock Options Exercisable (in shares) | shares | 5,221,749 |
Weighted-Average Exercise Price (in dollars per share) | $ 8.65 |
$1.47 - 4.96 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Granted Stock Options Outstanding (in shares) | shares | 2,004,807 |
Weighted- Average Remaining Contractual Life (in years) | 9 years 2 months 12 days |
Weighted-Average Exercise Price (in dollars per share) | $ 2.36 |
Granted Stock Options Exercisable (in shares) | shares | 426,557 |
Weighted-Average Exercise Price (in dollars per share) | $ 2.30 |
Exercise price, range lower limit (in dollars per share) | 1.47 |
Exercise price, range upper limit (in dollars per share) | $ 4.96 |
$4.97 - 6.91 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Granted Stock Options Outstanding (in shares) | shares | 1,953,056 |
Weighted- Average Remaining Contractual Life (in years) | 5 years 3 months 29 days |
Weighted-Average Exercise Price (in dollars per share) | $ 6 |
Granted Stock Options Exercisable (in shares) | shares | 1,899,501 |
Weighted-Average Exercise Price (in dollars per share) | $ 6 |
Exercise price, range lower limit (in dollars per share) | 4.97 |
Exercise price, range upper limit (in dollars per share) | $ 6.91 |
$6.92 - 9.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Granted Stock Options Outstanding (in shares) | shares | 1,628,613 |
Weighted- Average Remaining Contractual Life (in years) | 3 years 10 months 17 days |
Weighted-Average Exercise Price (in dollars per share) | $ 7.86 |
Granted Stock Options Exercisable (in shares) | shares | 1,482,404 |
Weighted-Average Exercise Price (in dollars per share) | $ 7.81 |
Exercise price, range lower limit (in dollars per share) | 6.92 |
Exercise price, range upper limit (in dollars per share) | $ 9 |
$9.01 - 12.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Granted Stock Options Outstanding (in shares) | shares | 968,289 |
Weighted- Average Remaining Contractual Life (in years) | 6 years 7 months 2 days |
Weighted-Average Exercise Price (in dollars per share) | $ 11.15 |
Granted Stock Options Exercisable (in shares) | shares | 566,565 |
Weighted-Average Exercise Price (in dollars per share) | $ 11.02 |
Exercise price, range lower limit (in dollars per share) | 9.01 |
Exercise price, range upper limit (in dollars per share) | $ 12 |
$12.01 - 22.64 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Granted Stock Options Outstanding (in shares) | shares | 1,101,858 |
Weighted- Average Remaining Contractual Life (in years) | 6 years 3 months 3 days |
Weighted-Average Exercise Price (in dollars per share) | $ 17.89 |
Granted Stock Options Exercisable (in shares) | shares | 846,722 |
Weighted-Average Exercise Price (in dollars per share) | $ 17.70 |
Exercise price, range lower limit (in dollars per share) | 12.01 |
Exercise price, range upper limit (in dollars per share) | $ 22.64 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Restricted Stock and Restricted Stock Unit Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Restricted Stock | ||
Number of Restricted Stock Awards | ||
Unvested, Beginning Balance (in shares) | 1,659,759 | 1,802,130 |
Granted (in shares) | 4,026,518 | 1,091,353 |
Share issuance upon approved achievement date (in shares) | (753,475) | (972,404) |
Forfeited (in shares) | (436,757) | (261,320) |
Unvested, Ending Balance (in shares) | 4,496,045 | 1,659,759 |
Weighted Average Fair Value per Share at Grant Date | ||
Beginning Balance (in dollars per share) | $ 11.67 | $ 12.75 |
Granted (in dollars per share) | 2.68 | 10.50 |
Share issuance upon approved achievement date (in dollars per share) | 11.23 | 11.70 |
Forfeited (in dollars per share) | 6.03 | 11.48 |
Ending Balance (in dollars per share) | $ 4.29 | $ 11.67 |
Restricted Stock Units (RSUs) | ||
Number of Restricted Stock Awards | ||
Unvested, Beginning Balance (in shares) | 385,919 | 255,214 |
Granted (in shares) | 6,800 | 257,585 |
Market-based achievement adjustment at vesting (in shares) | (128,334) | 116,880 |
Share issuance upon approved achievement date (in shares) | (861) | (243,760) |
Unvested, Ending Balance (in shares) | 263,524 | 385,919 |
Weighted Average Fair Value per Share at Grant Date | ||
Beginning Balance (in dollars per share) | $ 18 | $ 17.91 |
Granted (in dollars per share) | 2.36 | 12.87 |
Market-based achievement adjustment at vesting (in dollars per share) | 0 | 6.49 |
Share issuance upon approved achievement date (in dollars per share) | 10.69 | 7.04 |
Ending Balance (in dollars per share) | $ 26.39 | $ 18 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | Nov. 06, 2020 | Aug. 03, 2020 | Aug. 03, 2020 | Jul. 30, 2020 | Apr. 05, 2019 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 30, 2018 | May 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of common shares authorized (in shares) | 300,000,000 | 300,000,000 | 300,000,000 | 175,000,000 | ||||||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | ||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||
Shares sold in public offering (in shares) | 24,916,667 | |||||||||
Net proceeds | $ 69,700,000 | |||||||||
Underwriting discounts and offering expenses | $ 5,000,000 | |||||||||
Public Stock Offering | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares sold in public offering (in shares) | 21,666,667 | |||||||||
Shares sold in public offering (in dollars per share) | $ 3 | |||||||||
Net proceeds | $ 61,100,000 | |||||||||
Over-Allotment Option | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares sold in public offering (in shares) | 3,250,000 | 3,250,000 | ||||||||
Shares sold in public offering (in dollars per share) | $ 3 | $ 3 | ||||||||
Net proceeds | $ 9,200,000 | |||||||||
April 2019 ATM Agreement | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Maximum proceeds to be raised | $ 60,000,000 | $ 150,000,000 | $ 75,000,000 | |||||||
Stock options | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares of common stock issuable upon conversion or exercise of rights granted (in shares) | 5,200,000 | |||||||||
Restricted Stock Units (RSUs) | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares of common stock issuable upon conversion or exercise of rights granted (in shares) | 500,000 |
Stockholders' Equity - Sales Ag
Stockholders' Equity - Sales Agreement (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Equity [Abstract] | ||
Stock issued (in shares) | 3,950,398 | 221,529 |
Proceeds Received (Net of Broker Commissions and Fees ) | $ 14,902 | $ 1,814 |
Financial Commitments & Conti_3
Financial Commitments & Contingencies and Key License Agreements - Additional Information (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Dec. 31, 2020USD ($) | Apr. 30, 2019USD ($) | Apr. 30, 2018USD ($) | Apr. 30, 2016shares | Dec. 31, 2020USD ($)product | Dec. 31, 2019USD ($) | Jan. 01, 2019USD ($) | |
Long-term Purchase Commitment [Line Items] | |||||||
Operating lease, right-of-use assets | $ 2,247 | $ 2,247 | $ 3,806 | ||||
Operating lease, liability | 2,427 | $ 2,427 | 4,055 | ||||
Right-of-use asset obtained in exchange for operating lease liability | 5,300 | ||||||
Licensors | product | 2 | ||||||
Deferred compensation liability, current and noncurrent | 9,800 | $ 9,800 | 8,700 | ||||
SPI-2012 | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Issuance (in shares) | shares | 318,750 | ||||||
Spi Two Thousand Twelve | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Achievement of regulatory milestones | 10,000 | ||||||
Potential payments based on achievement of sales milestones (up to) | 120,000 | ||||||
Poziotinib | Licensing Agreements | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Achievement of regulatory milestones | 33,000 | ||||||
Potential payments based on achievement of sales milestones (up to) | 325,000 | ||||||
MD Anderson | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Achievement of regulatory milestones | 6,000 | ||||||
Potential payments based on achievement of sales milestones (up to) | 24,000 | ||||||
Payment of upfront fee | $ 500 | ||||||
ImmunGene, Inc. | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Achievement of regulatory milestones | 26,100 | ||||||
Asset purchase agreement, upfront payment | $ 2,800 | ||||||
Potential payments based on additional achievements of regulatory milestones | $ 5,000 | ||||||
Therapyx | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Asset purchase agreement, upfront payment | 800 | ||||||
Therapyx | Plan | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Potential payments based on additional achievements of regulatory milestones | 2,200 | ||||||
Potential payments based on worldwide annual net sales | 167,500 | ||||||
Therapyx | IL-12 Product | Plan | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Potential payments based on additional achievements of regulatory milestones | 30,000 | ||||||
Therapyx | Each new indication approved for each product in the U.S., Europe, or Japan | Plan | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Potential payments based on additional achievements of regulatory milestones | $ 2,500 | ||||||
Accounting Standards Update 2016-02 | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Operating lease, right-of-use assets | $ 4,200 | ||||||
Operating lease, liability | $ 5,300 | $ 4,200 | |||||
Minimum | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Remaining term | 1 year | 1 year | |||||
Maximum | |||||||
Long-term Purchase Commitment [Line Items] | |||||||
Remaining term | 3 years | 3 years |
Financial Commitments & Conti_4
Financial Commitments & Contingencies and Key License Agreements - Operating Lease Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Operating lease right-of-use assets - non-current | $ 2,247 | $ 3,806 |
Operating lease liabilities - current | 1,544 | 1,683 |
Operating lease liabilities - non-current | 883 | 2,372 |
Total lease liabilities | $ 2,427 | $ 4,055 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accounts payable and other accrued liabilities | Accounts payable and other accrued liabilities |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other long-term liabilities | Other long-term liabilities |
Office and research facilities | ||
Property, Plant and Equipment [Line Items] | ||
Operating lease right-of-use assets - non-current | $ 1,900 | $ 3,400 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Operating lease right-of-use assets - non-current | $ 300 | $ 400 |
Financial Commitments & Conti_5
Financial Commitments & Contingencies and Key License Agreements - Components of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 1,865 | $ 1,660 |
Variable lease cost | 411 | 470 |
Short-term lease cost | 61 | 77 |
Total lease cost | $ 2,337 | $ 2,207 |
Financial Commitments & Conti_6
Financial Commitments & Contingencies and Key License Agreements - Summary of Operating Lease Term and Discount Rate (Details) | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted Average Remaining Lease Term | 1 year 7 months 6 days | 2 years 6 months |
Weighted Average Discount Rate | 7.80% | 7.80% |
Financial Commitments & Conti_7
Financial Commitments & Contingencies and Key License Agreements - Operating Lease Minimum Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
2021 | $ 1,670 | |
2022 | 828 | |
2023 | 87 | |
2024 | 0 | |
2025 | 0 | |
Total future lease payments, undiscounted | 2,585 | |
(Less): Implied interest | (158) | |
Present value of operating lease payments | $ 2,427 | $ 4,055 |
Income Taxes - Components of (L
Income Taxes - Components of (Loss) Income before (Provision) Benefit for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (173,398) | $ (139,682) |
Foreign | 2,066 | (4,912) |
Total | $ (171,332) | $ (144,594) |
Income Taxes - Provision (Benef
Income Taxes - Provision (Benefit) for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Current: | ||
Federal | $ 0 | $ (6,584) |
State | (76) | (1,166) |
Foreign | 16 | 11 |
Current, total | (60) | (7,739) |
Deferred: | ||
Federal | 0 | (781) |
State | 0 | (688) |
Deferred, total | 0 | (1,469) |
Total income tax benefit | $ (60) | $ (9,208) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes [Line Items] | ||
Benefit for income taxes from continuing operations | $ 9,200 | |
Valuation allowance | $ 192,513 | 152,966 |
Increase (decrease) in valuation allowance due to deferred tax assets | 39,500 | 21,900 |
Research and development tax credits | 25,424 | 22,724 |
Unrecognized tax benefits, if recognized, would affect the effective tax rate | 100 | $ 100 |
Federal | ||
Income Taxes [Line Items] | ||
Net operating loss carryforwards | 600,700 | |
Research and development tax credits | 17,600 | |
State | ||
Income Taxes [Line Items] | ||
Net operating loss carryforwards | 349,700 | |
Research and development tax credits | 10,000 | |
Foreign | ||
Income Taxes [Line Items] | ||
Net operating loss carryforwards | $ 500 |
Income Taxes - Income Tax Provi
Income Taxes - Income Tax Provision (Benefit) Differs from Computed Using Federal Statutory Rate Applied to Income before Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Tax provision computed at the federal statutory rate | $ (35,980) | $ (30,365) |
State tax, net of federal benefit | (5,142) | (4,126) |
Research and development expense tax credits | (2,686) | (2,526) |
Change in uncertain tax benefit reserve | (27) | 0 |
Change in tax credit carryforwards | 109 | 81 |
Officers compensation | 2,497 | 1,506 |
Stock based compensation | 1,619 | (230) |
Permanent items and other | (37) | 267 |
Tax differential on foreign earnings | (1) | (31) |
Change in tax rate | (1,091) | 1,126 |
Refundable alternative minimum tax credit | 0 | 0 |
Change in prior year deferred taxes | (998) | 1,170 |
Valuation allowance | 41,677 | 23,920 |
Total income tax benefit | $ (60) | $ (9,208) |
Income Taxes - Components of Co
Income Taxes - Components of Company's Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 143,045 | $ 118,163 |
Research and development expense tax credits | 25,424 | 22,724 |
Stock based compensation | 4,037 | 4,385 |
Lease obligation | 599 | 919 |
Development costs | 487 | 704 |
Returns and allowances | 1,061 | 1,069 |
Amortization differences | 1,479 | 0 |
Depreciation | 4,746 | 0 |
Other, net | 17,420 | 11,861 |
Total deferred tax assets before valuation allowance | 198,298 | 159,825 |
Valuation allowance | (192,513) | (152,966) |
Total deferred tax assets | 5,785 | 6,859 |
Deferred tax liabilities, net: | ||
Unrealized gains | (5,230) | (5,607) |
Depreciation differences | 0 | (389) |
Right-of-use asset | (555) | (863) |
Net deferred tax liabilities | $ 0 | $ 0 |
Income Taxes - Summary of Unrec
Income Taxes - Summary of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 3,473 | $ 3,248 |
Adjustments related to prior year tax positions | (689) | (392) |
Increases related to current year tax positions | 579 | 692 |
Decreases due to expiration of tax statutes | (27) | (75) |
Balance at end of year | $ 3,336 | $ 3,473 |
Discontinued Operations - Conso
Discontinued Operations - Consolidated Statement of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
Other income (expense): | ||||
Income from discontinued operations, net of income taxes | $ 10,404 | $ 22,697 | ||
Commercial Product Portfolio | Sale | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | 10,668 | 22,615 | ||
Operating costs and expenses: | ||||
Selling, general and administrative | 219 | 5,801 | ||
Research and development | (43) | 2,624 | ||
Amortization of intangible assets | 0 | 1,248 | ||
Restructuring charges - employee severance | 0 | 3,858 | ||
Total operating costs and expenses | 264 | 25,538 | ||
Income (loss) from discontinued operations | 10,404 | (2,923) | ||
Other income (expense): | ||||
Change in fair value of contingent consideration | 0 | (1,478) | ||
Gain on sale of Commercial Product Portfolio | $ (1,100) | $ (200) | 0 | 34,568 |
Total other income (expense) | 0 | 33,090 | ||
Income from discontinued operations before income taxes | 10,404 | 30,167 | ||
Provision for income taxes from discontinued operations | 0 | (7,470) | ||
Income from discontinued operations, net of income taxes | 10,404 | 22,697 | ||
Commercial Product Portfolio | Sale | Product sales, net | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | 10,668 | 22,325 | ||
Operating costs and expenses: | ||||
Cost of goods and services sold | 88 | 12,007 | ||
Commercial Product Portfolio | Sale | License fees and service revenue | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | $ 0 | $ 290 |
Discontinued Operations - Addit
Discontinued Operations - Additional Information (Details) $ in Thousands | Jul. 03, 2020USD ($) | Mar. 01, 2019USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($)product | Dec. 31, 2018USD ($) |
Commercial Product Portfolio | CASI Out License | |||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Number of agreements | product | 3 | ||||||
Commercial Product Portfolio | Sale | |||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Proceeds from sale of discontinued operations | $ 158,800 | ||||||
Carrying value of net assets transferred | 121,200 | ||||||
Transaction expenses | $ 3,900 | ||||||
Discontinued Operation, Provision for Loss (Gain) on Disposal, before Income Tax | $ 1,100 | $ 200 | $ 0 | $ (34,568) | |||
Escrow deposits | $ 4,000 | ||||||
Pricing Of ZEVALIN To Qualifying Public Health Services | |||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||
Error correction amount | $ 12,000 | ||||||
Reduction to government chargebacks liability | $ 10,800 |
Discontinued Operations - Con_2
Discontinued Operations - Consolidated Statement of Cash Flows (Details) - Commercial Product Portfolio - Sale - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Depreciation and amortization | $ 0 | $ 1,263 |
Stock-based compensation | 0 | 3,404 |
Change in fair value of contingent consideration | $ 0 | $ 1,478 |
Restructuring Costs Related T_2
Restructuring Costs Related To Sale Of Commercial Product Portfolio (Details) $ in Thousands | Mar. 01, 2019employee | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | May 31, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Restructuring Cost and Reserve [Line Items] | ||||||||||||
Number of employees terminated | employee | 87 | |||||||||||
Revenues | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | ||
Employee Severance | ||||||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||||||
Restructuring and related cost, expected cost remaining | $ 0 | $ 300 | $ 0 | 300 | ||||||||
Employee Severance | Employee Severance, Terminated March 1, 2019 | ||||||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||||||
Restructuring costs | 5,100 | |||||||||||
Employee Severance | Employee Severance, Terminated March 1, 2019 | Income (Loss) From Discontinued Operations | ||||||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||||||
Restructuring costs | 3,900 | |||||||||||
Employee Severance | Employee Severance, Terminated March 1, 2019 | Selling, General and Administrative Expenses | ||||||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||||||
Restructuring costs | 1,000 | |||||||||||
Employee Severance | Employee Severance, Terminated March 1, 2019 | Research and Development Expense | ||||||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||||||
Restructuring costs | 200 | |||||||||||
Employee Severance | Employee Severance, Terminated May 31, 2019 | ||||||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||||||
Restructuring costs | $ 500 | 500 | ||||||||||
Acrotech Biopharma LLC | Service | ||||||||||||
Restructuring Cost and Reserve [Line Items] | ||||||||||||
Revenues | $ 700 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||
Revenues | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
Loss from continuing operations before other income (expense) and income taxes | (62,888) | (39,569) | (36,490) | (30,787) | (38,355) | (30,293) | (34,212) | (37,838) | (169,734) | (140,698) |
Loss from continuing operations | $ (49,908) | $ (48,518) | $ (32,229) | $ (40,617) | $ (40,200) | $ (26,557) | $ (28,783) | $ (39,846) | $ (171,272) | $ (135,386) |
Net loss per share - basic and diluted (in dollars per share) | $ (0.36) | $ (0.37) | $ (0.29) | $ (0.36) | $ (0.36) | $ (0.24) | $ (0.26) | $ (0.36) | $ (1.29) | $ (1.02) |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Millions | Aug. 03, 2020 | Feb. 28, 2021 |
Subsequent Event [Line Items] | ||
Number of shares issued in transaction | 24,916,667 | |
Net proceeds | $ 69.7 | |
Subsequent Event | April 2019 ATM Agreement | ||
Subsequent Event [Line Items] | ||
Number of shares issued in transaction | 5,678,893 | |
Net proceeds | $ 21.4 |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Details) - SEC Schedule, 12-09, Allowance, Credit Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at Beginning of Period | $ 43 | $ 67 |
Additions (Recovery) to Bad Debt Expense | 169 | (12) |
Charged to Other Accounts | 0 | 43 |
Deductions | 0 | (55) |
Balance at End of Period | $ 212 | $ 43 |