Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 22, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
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 | Pilot House - Lewis Wharf, 2 Atlantic Ave | ||
Entity Address, Address Line Two | 6th Floor | ||
Entity Address, City or Town | Boston | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02110 | ||
City Area Code | 617 | ||
Local Phone Number | 586-3900 | ||
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 | $ 115.4 | ||
Entity Common Stock, Shares Outstanding | 205,301,402 | ||
Documents Incorporated by Reference | Certain information required by Parts II and III are omitted from this Annual Report on Form 10-K and incorporated by reference to our definitive proxy statement for our 2023 annual meeting of shareholders (“2023 Proxy Statement”), to be filed pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, or the Exchange Act. If our 2023 Proxy Statement is not filed within 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, the omitted information will be included in an amendment to this Annual Report on Form 10-K filed not later than the end of such 120-day period. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0000831547 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Auditor Information [Abstract] | |
Auditor Name | RSM US LLP |
Auditor Location | Los Angeles, California |
Auditor Firm ID | 49 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 40,368 | $ 88,539 |
Marketable securities | 34,728 | 12,108 |
Accounts receivable, net | 12,996 | 0 |
Other receivables | 617 | 1,028 |
Inventories | 9,230 | 0 |
Prepaid expenses and other current assets | 3,072 | 2,277 |
Total current assets | 101,011 | 103,952 |
Property and equipment, net | 476 | 455 |
Facility and equipment under lease | 1,694 | 2,505 |
Other assets | 157 | 4,636 |
Total assets | 103,338 | 111,548 |
Current liabilities: | ||
Accounts payable and other accrued liabilities | 38,105 | 41,258 |
Accrued payroll and benefits | 4,580 | 11,971 |
Total current liabilities | 42,685 | 53,229 |
Loan payable, long-term | 28,666 | 0 |
Other long-term liabilities | 4,099 | 10,766 |
Total liabilities | 75,450 | 63,995 |
Commitments and contingencies (Note 8) | ||
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; 202,827,831 and 164,502,013 issued and outstanding at December 31, 2022 and 2021, respectively | 203 | 165 |
Additional paid-in capital | 1,149,926 | 1,094,353 |
Accumulated other comprehensive loss | (2,917) | (3,042) |
Accumulated deficit | (1,119,324) | (1,043,923) |
Total stockholders’ equity | 27,888 | 47,553 |
Total liabilities and stockholders’ equity | $ 103,338 | $ 111,548 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 202,827,831 | 164,502,013 |
Common stock, shares outstanding (in shares) | 202,827,831 | 164,502,013 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Net sales | $ 10,114 | $ 0 |
Expenses: | ||
Cost of sales | 1,792 | 0 |
Selling, general and administrative | 38,816 | 60,406 |
Research and development | 42,203 | 87,297 |
Total expenses | 82,811 | 147,703 |
Loss from continuing operations before other income (expense) and income taxes | (72,697) | (147,703) |
Other income (expense): | ||
Interest income | 968 | 215 |
Interest expense | (998) | (52) |
Other expense, net | (5,331) | (10,892) |
Total other expense | (5,361) | (10,729) |
Loss from continuing operations before income taxes | (78,058) | (158,432) |
Provision for income taxes from continuing operations | (46) | (4) |
Loss from continuing operations | (78,104) | (158,436) |
Income (loss) from discontinued operations, net of income taxes | 2,703 | (192) |
Net loss | $ (75,401) | $ (158,628) |
Basic and diluted income (loss) per share: | ||
Loss per common share from continuing operations, basic (in dollars per share) | $ (0.43) | $ (1.02) |
Loss per common share from continuing operations, diluted (in dollars per share) | (0.43) | (1.02) |
Income per common share from discontinued operations, basic (in dollars per share) | 0.01 | 0 |
Income per common share from discontinued operations, diluted (in dollars per share) | 0.01 | 0 |
Net loss per common share, basic (in dollar per share) | (0.41) | (1.02) |
Net loss per common share, diluted (in dollar per share) | $ (0.41) | $ (1.02) |
Weighted average shares outstanding, basic (in shares) | 183,237,200 | 154,861,704 |
Weighted average shares outstanding, diluted (in shares) | 183,237,200 | 154,861,704 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (75,401) | $ (158,628) |
Other comprehensive (loss) income: | ||
Unrealized loss on available-for-sale securities, net of tax | (11) | (1,147) |
Foreign currency translation adjustments | 136 | (66) |
Other comprehensive income (loss) | 125 | (1,213) |
Total comprehensive loss | $ (75,276) | $ (159,841) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | At-the-market Sales Agreement | Hanmi | Market Offering | Common Stock | Common Stock At-the-market Sales Agreement | Common Stock Hanmi | Common Stock Market Offering | Additional Paid-In Capital | Additional Paid-In Capital At-the-market Sales Agreement | Additional Paid-In Capital Hanmi | Additional Paid-In Capital Market Offering | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance, (in shares) at Dec. 31, 2020 | 146,083,110 | |||||||||||||
Beginning Balance at Dec. 31, 2020 | $ 134,243 | $ 146 | $ 1,021,221 | $ (1,829) | $ (885,295) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Net loss | (158,628) | (158,628) | ||||||||||||
Other comprehensive (loss) income | (1,213) | (1,213) | ||||||||||||
Recognition of stock-based compensation expense | $ 19,839 | 19,839 | ||||||||||||
Issuance of common shares (in shares) | 15,851,391 | 15,851,391 | ||||||||||||
Issuance of common shares | $ 52,621 | $ 16 | $ 52,605 | |||||||||||
Issuance of common stock for employee stock purchase plan (in shares) | 358,007 | |||||||||||||
Issuance of common stock for employee stock purchase plan | $ 685 | $ 1 | 684 | |||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,250 | 1,250 | ||||||||||||
Issuance of common stock upon exercise of stock options | $ 4 | 4 | ||||||||||||
Restricted stock award grants, net of forfeitures (in shares) | 2,206,869 | |||||||||||||
Restricted stock award grants, net of forfeitures | $ 2 | $ 2 | ||||||||||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 1,386 | |||||||||||||
Ending Balance, (in shares) at Dec. 31, 2021 | 164,502,013 | 164,502,013 | ||||||||||||
Ending Balance at Dec. 31, 2021 | $ 47,553 | $ 165 | 1,094,353 | (3,042) | (1,043,923) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Net loss | (75,401) | (75,401) | ||||||||||||
Other comprehensive (loss) income | 125 | 125 | ||||||||||||
Recognition of stock-based compensation expense | $ 8,490 | 8,490 | ||||||||||||
Issuance of common shares (in shares) | 24,513,945 | 12,500,000 | 24,513,945 | |||||||||||
Issuance of common shares | $ 20,000 | $ 26,561 | $ 12 | $ 25 | $ 19,988 | $ 26,536 | ||||||||
Issuance of common stock for employee stock purchase plan (in shares) | 619,372 | |||||||||||||
Issuance of common stock for employee stock purchase plan | $ 330 | $ 1 | 329 | |||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 0 | |||||||||||||
Restricted stock award grants, net of forfeitures (in shares) | 407,488 | |||||||||||||
Restricted stock award grants, net of forfeitures | $ 0 | |||||||||||||
Issuance of common stock upon vesting of performance units (in shares) | 150,000 | |||||||||||||
Issuance of warrants upon debt financing | $ 230 | 230 | ||||||||||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 135,013 | |||||||||||||
Ending Balance, (in shares) at Dec. 31, 2022 | 202,827,831 | 202,827,831 | ||||||||||||
Ending Balance at Dec. 31, 2022 | $ 27,888 | $ 203 | $ 1,149,926 | $ (2,917) | $ (1,119,324) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash Flows From Operating Activities: | ||
Loss from continuing operations | $ (78,104) | $ (158,436) |
Income (loss) from discontinued operations, net of income taxes | 2,703 | (192) |
Net loss | (75,401) | (158,628) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 248 | 286 |
Amortization of debt discount | 195 | 0 |
Stock-based compensation | 8,490 | 19,841 |
Loss on disposal of manufacturing equipment | 0 | 3,057 |
Non-cash lease expense | 705 | 1,624 |
Amortization of premium (discount) on debt securities | (467) | 393 |
Realized loss (gain) on mutual funds | 17 | (630) |
Realized loss (gain) on sale of equity holdings | 1,346 | (5,722) |
Unrealized loss on equity holdings | 2,919 | 17,266 |
Unrealized loss from transactions denominated in foreign currency | 76 | 460 |
Other non-cash items | 105 | (80) |
Loss on disposal of assets | 2 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (12,996) | 66 |
Other receivables | 399 | 1,444 |
Inventories | (9,230) | 0 |
Prepaid expenses and other current assets | (795) | 1,884 |
Other assets | 4,479 | (310) |
Accounts payable and other accrued liabilities | (3,709) | (3,513) |
Accrued payroll and benefits | (7,391) | 2,596 |
Other long-term liabilities | (5,981) | 480 |
Net cash used in operating activities | (96,989) | (119,486) |
Cash Flows From Investing Activities: | ||
Proceeds from maturities of investments | 5,967 | 119,814 |
Proceeds from sale of equity holdings | 2,166 | 5,974 |
Purchases of investments | (34,578) | (16,856) |
Purchases of property and equipment, net | (273) | (221) |
Net cash (used in) provided by investing activities | (26,718) | 108,711 |
Cash Flows From Financing Activities: | ||
Proceeds from the issuance of debt, net of debt acquisition costs | 28,700 | 0 |
Issuance of common shares to Hanmi Pharmaceutical Co., Ltd. | 20,000 | 0 |
Proceeds from employees for exercises of stock options | 0 | 4 |
Proceeds from sale of stock under employee stock purchase plan | 330 | 685 |
Net cash provided by financing activities | 75,591 | 53,310 |
Effect of exchange rates on cash and cash equivalents | (55) | (5) |
Net (decrease) increase in cash and cash equivalents | (48,171) | 42,530 |
Cash and cash equivalents — beginning of year | 88,539 | 46,009 |
Cash and cash equivalents — end of year | 40,368 | 88,539 |
Supplemental Disclosure of Cash Flow Information: | ||
Cash paid for facility and equipment under operating leases | 1,693 | 2,116 |
Cash paid for income taxes | 39 | 12 |
Cash paid for interest | 792 | 0 |
Supplemental disclosure of cash flow information-Non-cash: | ||
Issuance of warrants in connection with debt financing | 230 | 0 |
At-the-market Sales Agreement | ||
Cash Flows From Financing Activities: | ||
Proceeds from sale of common stock under an at-the-market sales agreement, net | $ 26,561 | $ 52,621 |
Description of Business, Basis
Description of Business, Basis of Presentation, and Operating Segment | 12 Months Ended |
Dec. 31, 2022 | |
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 commercial-stage biopharmaceutical company, with a strategy of acquiring, developing, and commercializing novel and targeted oncology therapies. We have an in-house clinical development organization with regulatory and data management capabilities, in addition to commercial infrastructure and a field based sales force for our marketed product, ROLVEDON™ (formerly known as eflapegrastim). We have one commercial asset and one drug candidate in late-stage development: • ROLVEDON ™ is a novel long-acting granulocyte colony-stimulating factor (“G-CSF”) for the treatment of chemotherapy-induced neutropenia. On April 11, 2022, we announced that we had received notice that the Biologics License Application (“BLA”) for ROLVEDON had been accepted for filing and received a Prescription Drug User Fee Act (“PDUFA”) date of September 9, 2022. On September 9, 2022, we received the U.S. Food and Drug Administration’s (“FDA”) marketing approval for ROLVEDON and began commercialization activities in the fourth quarter of 2022; and • Poziotinib is a novel irreversible TKI under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations. On December 6, 2021, we announced we submitted our New Drug Application (“NDA”) for poziotinib to the FDA for use in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations. The NDA submission is based on the positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib. The product candidate received fast track designation from the FDA and there is currently no treatment specifically approved by the FDA for this indication. On February 11, 2022, we announced that we received notice from the FDA that the NDA was accepted for filing and received a PDUFA action date of November 24, 2022. On September 22, 2022, we met with the FDA’s Oncologic Drugs Advisory Committee (“ODAC”). The ODAC voted 9 (no) - 4 (yes) that the current benefits of poziotinib did not outweigh its risks for the treatment of patients with NSCLC with HER2 exon 20 insertion mutations. On November 25, 2022, we announced that we had received a Complete Response Letter (“CRL”) from the FDA regarding our NDA. The CRL stated that the FDA determined that it could not approve the NDA in its present form and provided recommendations needed for resubmission, including generating additional data from a randomized controlled study prior to approval. We are continuing to evaluate these recommendations but we have de-prioritized further poziotinib development activities. Our business strategy is the development of late-stage assets through commercialization and the sourcing of additional assets that are synergistic with our existing portfolio (through purchase acquisitions, in-licensing transactions, or co-development and marketing arrangements). (b) Basis of Presentation 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 consolidated financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. Substantially all of the accumulated other comprehensive loss is comprised of foreign currency translation adjustments at December 31, 2022. The consolidated financial statements have been prepared on a going concern basis, which assumes that the Company will continue in operational existence for the foreseeable future. Foreign Currency Translation Operations in non-U.S. entities are recorded in the functional currency of each entity. For financial reporting purposes, the functional currency of an entity is determined by a review of the source of an entity's most predominant cash flows. The results of operations for any non-U.S. dollar functional currency entities are translated from functional currencies into U.S. dollars using the average currency rate during each month. Assets and liabilities are translated using currency rates at the end of the period. Adjustments resulting from translating the financial statements of our foreign entities that use their local currency as the functional currency into U.S. dollars are reflected as a component of other comprehensive income (loss). Transaction gains and losses are recorded in other income (expense), net, in the consolidated statements of operations. Discontinued Operations - Sale of our Commercial Product Portfolio In March 2019, we completed the sale of our Commercial Product Portfolio (as defined below in Note 10 ) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). In accordance with applicable GAAP ( Accounting Standards Codification, “ASC”, 205-20, Presentation of Financial Statements ), the revenue-deriving activities and allocable expenses of our sold commercial operations, connected to the Commercial Product Portfolio, are separately classified as “discontinued” for all periods presented within the accompanying Consolidated Statements of Operations. Liquidity and Capital Resources We expect to incur future net losses as we continue to fund the advancement and commercialization of our product and product candidates. Based upon our current projections, including our intention to continue to place a disciplined focus on streamlining our business operations, we believe that our $75.1 million in aggregate cash, cash equivalents, and marketable securities as of December 31, 2022 will be sufficient to fund our current and planned operations for at least the next twelve months from the date this Annual Report is filed with the SEC. However, should our net sales prove to be less than we currently anticipate, or our costs and expenses prove to be greater than we currently anticipate, or should we change our current business plan in a manner that increases or accelerates our anticipated costs and expenses, we may require additional liquidity earlier than expected. Until and unless we can generate substantial product revenue, we expect to finance our cash needs through the public or private sale of debt or equity securities, out-licensing arrangements, funding from joint-venture or strategic partners, debt financing or short-term loans, or through a combination of the foregoing. We cannot provide any assurance that we will be able to obtain additional liquidity on terms favorable to us or our current stockholders, or at all. Our liquidity and our ability to fund our capital requirements going forward are dependent, in part, on market and economic factors that are beyond our control. The Company may never achieve profitability or generate positive cash flows, and unless and until it does, the Company will continue to need to raise additional capital. As of December 31, 2022, we have approximately $128.8 million remaining to be sold pursuant to the April 2019 ATM Agreement, subject to the availability of authorized shares. On September 21, 2022, we entered into a Loan and Security Agreement (“Loan Agreement”), by and among the Company and its subsidiaries, Allos Therapeutics, Inc., Talon Therapeutics, Inc., and Spectrum Pharmaceuticals International Holdings, LLC, as borrowers (together with the Company, the “Borrowers”), SLR Investment Corp. (“SLR”), as administrative agent (the “Agent”), and the lenders party thereto (the “Lenders”) that provides for a five-year senior secured term loan facility in an aggregate principal amount of up to $65.0 million available to us in four tranches (collectively, the “Term Loans”). As of December 31, 2022, we had drawn a total of $30.0 million of the Term Loans pursuant to the Loan Agreement, with a remaining undrawn principal balance of $25.0 million, which is available through November 15, 2023 and is subject to the achievement of certain milestone events. As we did not satisfy the Term B Loan Funding Condition we will be unable to draw the Term B Loan of $10.0 million (as those terms are defined in the Loan Agreement). Refer to Note 5 for additional information. (c) Operating Segment |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Use of Estimates | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES The preparation of financial statements in conformity with GAAP requires our management to make informed estimates and assumptions that affect our reported amounts of assets, liabilities, revenues, and expenses. These amounts may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. On an on-going basis, our management evaluates (as applicable) its most critical estimates and assumptions, including those described below: (i) Revenue Recognition We recognize ROLVEDON revenue in accordance with ASC 606 – Revenue from contracts with customers. Our revenue recognition analysis consists of the following steps: (i) identification of the promised goods in the contract; (ii) determination of whether the promised goods are performance obligations, including whether they are capable of being distinct; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue as we satisfy each performance obligation. ROLVEDON became available for commercial sale and shipment to patients with a prescription in the U.S. in the fourth quarter of 2022. We sell our products to pharmaceutical wholesalers/distributors (i.e., our customers) who in turn sell our products directly to clinics, hospitals, and federal healthcare programs. 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. The transaction price that we recognize for ROLVEDON revenue is our gross product sales reduced by our corresponding gross-to-net (“GTN”) estimates using the expected value method, resulting in our reported “net sales” in the accompanying Consolidated Statements of Operations. Net sales 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 GPO administrative fees may be above or below the amount estimated, then requiring prospective adjustments to our reported net sales. These GTN estimate categories (that comprise our GTN liabilities) are each discussed below: Product Returns Allowances : Our customers are contractually permitted to return certain purchased products within the contractual allowable time before/after the applicable expiration date. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns using our expected return rates. Returned product is typically destroyed since substantially all are due to imminent expiry and cannot be resold. Government Chargebacks : Our product is subject to pricing limits under certain federal government programs (e.g., Medicare, Medicaid, 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 product is 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 of similar products 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. (ii) Cash and Cash Equivalents Cash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. (iii) Marketable Securities Marketable securities consist of our holdings in equity securities (including mutual funds), bank CDs, government-related debt securities, and corporate debt securities. For equity securities and mutual funds, any realized or unrealized gains (losses) are recognized in “other income (expense), net” within the Consolidated Statements of Operations. Debt securities and bank CDs are classified as “available-for-sale” investments and (1) realized gains (losses) are recognized in “other income (expense), net” within the Consolidated Statements of Operations and (2) unrealized gains (losses) are recognized as a component of “accumulated other comprehensive loss” within the Consolidated Statements of Stockholders’ Equity. (iv) Accounts Receivable, net In general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns and chargebacks. As of December 31, 2022, these allowances amounted to $1.3 million. Our contracts with customers have standard payment terms. As of December 31, 2022, the majority of our sales were to the top three wholesalers. We analyze accounts that are past due for collectability, and regularly evaluate the creditworthiness of our customers so that we can properly assess and respond to changes in their credit profiles. As of December 31, 2022, we determined an allowance for expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances. (v) Inventory We value our inventory at the lower of cost or net realizable value. Inventory cost is determined on a first-in, first-out basis. We regularly review our inventory quantities and when appropriate record a provision for obsolete and excess inventory to derive its new cost basis, which takes into account our sales forecast and corresponding expiry dates. We have not recognized a provision for obsolete and excess inventory as of December 31, 2022. We received FDA approval for ROLVEDON on September 9, 2022, and on that date began capitalizing inventory purchases of saleable product from certain suppliers. Prior to FDA approval, all saleable product purchased from such suppliers were included as a component of research and development expense, as we were unable to assert that the inventory had future economic benefit until we had received FDA approval. Prior to FDA approval, costs estimated at approximately $5.7 million for commercially saleable product and materials were incurred and included in research and development expenses. If we were to have included those costs previously expensed as a component of cost of sales, our cost of sales for the year ended December 31, 2022 would have been $3.0 million. As a result, cost of sales related to ROLVEDON will initially reflect a lower average per unit cost of materials over the next approximately nine months as previously expensed inventory is utilized for commercial production and sold to customers. (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 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. (vii) Cost of Sales Cost of sales includes the cost of the inventory sold, which includes direct manufacturing, production and packaging materials, shipping expenses, and royalty fees owed to our licensing partner for ROLVEDON sales. Prior to FDA approval in September 2022, we expensed approximately $5.7 million in costs associated with the manufacturing of ROLVEDON as a component of research and development expense. Therefore these costs are not included in cost of sales. (viii) 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, and 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. The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires certain 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), (d) zero dividend yield, and (e) the prevailing risk-free interest rate for the period matching the expected term. With regard to (a)-(e) 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 and we estimate a zero dividend yield. Due to the inherent uncertainty of these estimates, the actual amounts incurred may be above or below the amount estimated, then requiring prospective adjustments to our stock-based compensation expense. (ix) 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 is the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only stock options, warrants, and other common stock equivalents outstanding during the period to the extent that they are dilutive. There were 22.3 million shares and 13.5 million shares of outstanding securities (including stock options, restricted stock units, unvested restricted stock awards, stock appreciation rights, warrants and performance awards) as of December 31, 2022 and 2021, respectively, that were excluded from the calculation of diluted net loss per share because their inclusion would have been anti-dilutive. (x) 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. Our effective tax rate differs from the U.S. federal statutory tax rate primarily as a result of nondeductible expenses and the impact of a valuation allowance on our deferred tax assets, which we record because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income or reduce our net loss 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 “provision for income taxes from continuing operations” within the accompanying Consolidated Statements of Operations for the period in which we received the notice. (xi) Research and Development Expenses Our research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, benefits, and other staff-related costs including associated stock-based compensation, laboratory supplies, clinical trial and related clinical manufacturing costs, costs related to manufacturing preparations, fees paid to other entities that conduct certain research and development activities on our behalf and payments made pursuant to license agreements. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. We accrue for costs incurred as the services are being provided by monitoring the status of activities and the invoices received from our external service providers. We adjust our accruals as actual costs become known. Where contingent milestone payments are due to third parties under research and development or license agreements, the milestone payment obligations are expensed in the earliest period that we determine the respective milestone achievement is probable or has occurred. (xii) Debt Issuance Costs Debt issuance costs incurred in connection with the Term Loan is classified on the consolidated balance sheet as a direct deduction from the carrying amount of the related debt liability. These expenses are deferred and amortized as part of interest expense in the consolidated statement of operations using the effective interest rate method over the term of the debt agreement. Refer to Note 5 for additional information on the Term Loan. (xiii) 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. (xiv) Recently Issued Accounting Standards In June 2022, the FASB issued Accounting Standards Update No. 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard becomes effective for us on January 1, 2024, and is not expected to have a material impact on our consolidated financial statements and related disclosures. There are several other new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”), which we do not believe had or will have a material impact on our consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The table below summarizes certain asset and liability fair values that are included within our accompanying Consolidated Balance Sheets, and their designations among the three fair value measurement categories: December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 36,298 $ — $ — $ 36,298 Equity securities 136 — — 136 Government-related debt securities 30,348 — — 30,348 Mutual funds 4,244 8 — 4,252 $ 71,026 $ 8 $ — $ 71,034 Liabilities: Deferred executive compensation liability (1) $ — $ 4,531 $ — $ 4,531 $ — $ 4,531 $ — $ 4,531 (1) Included $1.5 million within accounts payable and other accrued liabilities and $3.0 million within other long-term liabilities on our Consolidated Balance Sheets. December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Equity securities $ 5,718 $ — $ — $ 5,718 Money market funds 66,322 — — 66,322 Mutual funds 6,390 9 — 6,399 Key employee life insurance, cash surrender value (1) — 4,507 — 4,507 $ 78,430 $ 4,516 $ — $ 82,946 Liabilities: Deferred executive compensation liability (2) $ — $ 11,243 $ — $ 11,243 $ — $ 11,243 $ — $ 11,243 (1) Included within other assets on our Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. (2) Included $2.0 million within accounts payable and other accrued liabilities and $9.2 million within other long-term liabilities on our Consolidated Balance Sheets. Our carrying amounts of financial instruments such as cash equivalents, accounts receivable, prepaid expenses, accounts payable and other accrued liabilities approximate their fair values due to their short-term nature of settlement. In addition, at December 31, 2022, the Company believed the carrying value of debt approximates fair value as the interest rates were reflective of the rate the Company could obtain on debt with similar terms and conditions. |
Balance Sheet Account Detail
Balance Sheet Account Detail | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Account Detail | BALANCE SHEET ACCOUNT DETAIL The composition of selected financial statement captions that comprise the accompanying 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 and money market funds approximate their fair value (utilizing “ Level 1” or “ Level 2” inputs) because of our ability to immediately convert these instruments into cash with minimal expected change in value. There were no material unrealized losses on our investment securities at December 31, 2022 or 2021. The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Fair Value Cash and Cash Marketable Securities December 31, 2022 Money market funds $ 36,298 $ 36,298 $ 36,298 $ — Equity securities (1) — 136 — 136 Government-related debt securities 30,359 30,348 — 30,348 Mutual funds 3,395 4,244 — 4,244 Bank deposits 4,070 4,070 4,070 — Total cash and cash equivalents and marketable securities $ 74,122 $ 75,096 $ 40,368 $ 34,728 December 31, 2021 Money market funds $ 66,322 $ 66,322 $ 66,322 $ — Equity securities 3,512 5,718 — 5,718 Mutual funds 5,218 6,390 — 6,390 Bank deposits 22,217 22,217 22,217 — Total cash and cash equivalents and marketable securities $ 97,269 $ 100,647 $ 88,539 $ 12,108 (1) Our aggregate equity holdings consist of 0.3 million common shares of Unicycive Therapeutics, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $0.1 million as of December 31, 2022. We completed the sale of 0.6 million shares of common stock and recognized a $0.5 million gain within “other expense, net” within the accompanying Consolidated Statements of Operations for the year ended December 31, 2022. Additionally, we completed the sale of our remaining 0.9 million shares of CASI Pharmaceuticals, Inc., a NASDAQ-listed biopharmaceutical company, and recognized a $1.9 million loss within “other expense, net” within the accompanying Consolidated Statements of Operations for the year ended December 31, 2022. We no longer hold any shares of CASI Pharmaceuticals, Inc. (b) Inventories Upon approval of ROLVEDON on September 9, 2022, we began capitalizing our purchases of saleable inventory of ROLVEDON from suppliers. Inventories consist of the following: December 31, 2022 2021 Raw materials $ 4,500 $ — Work-in-process 4,007 — Finished goods 723 — Inventories $ 9,230 $ — (c) Accounts Payable and Other Accrued Liabilities “Accounts payable and other accrued liabilities” consists of the following, with “Product revenue allowances – ROLVEDON” being as of and for the year ended December 31, 2022: December 31, 2022 2021 Trade accounts payable and other $ 30,547 $ 33,408 Lease liability - current portion 761 1,282 Product revenue allowances - ROLVEDON 3,082 — Commercial Product Portfolio accruals (Note 10) 3,715 6,568 Accounts payable and other accrued liabilities $ 38,105 $ 41,258 Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Consolidated Balance Sheets for our categories of gross-to-net (“GTN”) estimates related to discontinued operations (Commercial Product Portfolio) accruals were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, Product Return Allowances Total Balance as of December 31, 2020 $ 2,601 $ 942 $ 4,299 $ 7,842 (Less): Payments and credits against GTN accruals (1,159) — (115) (1,274) Balance as of December 31, 2021 1,442 942 4,184 6,568 (Less): Payment and credits against GTN accruals (5) 93 (203) (115) (Less): Release of GTN accruals (117) (871) (1,750) (2,738) Balance as of December 31, 2022 $ 1,320 $ 164 $ 2,231 $ 3,715 |
Loan Payable
Loan Payable | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Loan Payable | LOAN PAYABLE On September 21, 2022, we entered into the Loan Agreement that provides for a five-year senior secured term loan facility in an aggregate principal amount of up to $65.0 million, available to us in four tranches. Upon entering into the Loan Agreement in September 2022, we borrowed $30.0 million in term loans (the “Term A Loan”). As we did not satisfy the Term B Loan Funding Condition, we will be unable to draw the Term B Loan of $10.0 million (as those terms are defined in the Loan Agreement). As of December 31, 2022, we may borrow up to an additional $25.0 million in term loans subject to us achieving the following milestones: a. Through May 15, 2023, $15.0 million (the “Term C Loan”) if we provide satisfactory evidence that we have achieved a minimum of $15.7 million in Net Product Revenue (as defined in the Loan Agreement) calculated on a trailing six (6) month basis for any measuring period ending on or prior to March 31, 2023; and b. Through November 15, 2023, $10.0 million (the “Term D Loan”) if we provide satisfactory evidence that we have achieved a minimum of $40.0 million in Net Product Revenue calculated on a trailing six (6) month basis for any measuring period ending on or prior to September 30, 2023. The Loan Agreement contains customary events of default and representations, warranties and affirmative and negative covenants, including financial covenants requiring the Company to (i) maintain certain levels of cash in accounts subject to a control agreement in favor of the Agent of at least $25.0 million at all times commencing from September 21, 2022 and ending on the later of (A) July 31, 2023 and (B) the date Company either (1) receives, on or after September 13, 2022, at least $40.0 million in net cash proceeds from equity raises and/or business development or collaboration agreements or (2) (x) receives, on or after September 13, 2022, at least $30.0 million in net cash proceeds from equity raises and/or business development or collaboration agreements and (y) achieves at least $25.8 million in trailing 6-month net revenue from the sale of any products (on or prior to the period ending July 31, 2023) and (ii) maintain, commencing March 31, 2023, on a monthly basis until the end of 2023, and on a quarterly basis thereafter, either (A) net revenue from the sale of any products of at least $100 million on a trailing 12-month basis, or (B) net revenue from the sale of any products of an amount set forth in the Loan Agreement, on a trailing 6-month basis. The Term Loans are guaranteed by certain of our subsidiaries (the “Guarantors”). Our obligations under the Loan Agreement are secured by a pledge of substantially all of our assets and are secured by a pledge of substantially all of the assets of the Guarantors. The Term Loans bear interest at a floating rate per annum equal to the 1-Month CME Term SOFR (subject to a 2.3% floor) plus 5.7%. Interest-only payments are due beginning on November 1, 2022 through September 30, 2025, and the interest-only period may be extended to September 30, 2026 (“Principal Extension”) provided the Company and its subsidiaries have achieved a minimum of $40.0 million in net product revenue on a trailing six-month basis for any measuring period ending on or prior to September 30, 2023. We are also required to make monthly principal payments beginning on October 1, 2025 in an amount equal to 1/24th of the aggregate amount of the Term Loans outstanding if the Principal Extension is not executed, or, beginning on October 1, 2026, 1/12th of the aggregate amount of the Term Loans outstanding if the Principal Extension is executed. On the maturity date of September 1, 2027, we are required to pay in full all outstanding Term Loans and other amounts owed under the Loan Agreement. At the time of borrowing any tranche of the Term Loans, we are required to pay an upfront fee of 1.0% of the aggregate principal amount borrowed at that time. We may prepay all of the Term Loans, and are required to make mandatory prepayments of the Term Loans upon the occurrence of a bankruptcy or insolvency event (including the acceleration of claims by operation of law). All mandatory and voluntary prepayments of the Term Loans are subject to prepayment premiums equal to (i) 3% of the principal prepaid if prepayment occurs on or before September 21, 2023, (ii) 2% of the principal prepaid if prepayment occurs after September 21, 2023 but on or before September 21, 2024, or (iii) 1% of the principal prepaid if prepayment occurs after September 21, 2024. We will pay facility fees and success fees upon borrowing the future tranches as follows: a. Facility fee of $0.2 million and success fee of 0.75% of the principal of the Term C Loans, and b. Facility fee of $0.1 million and success fee of 0.75% of the principal of the Term D Loans. In addition, we are required to pay an exit fee in an amount equal to 4.75% of all principal repaid, whether as a mandatory prepayment, voluntary prepayment, or a scheduled repayment. In connection with the Loan Agreement, we granted warrants (“Warrants”) to the Lenders to purchase up to 454,545 shares of our common stock at an exercise price of $0.66 per share, which had a fair market value at time of issuance of $0.2 million. The number of shares and exercise price are subject to anti-dilution adjustments for splits, dividends, capital reorganizations, reclassifications and similar transactions. Upon borrowing the future tranches, we will issue warrants to the Lenders to purchase an aggregate number of shares of common stock equal to 1.0% of the Term Loan amount funded divided by the applicable Exercise Price (as defined below). The Exercise Price is defined as the lesser of (a) the 10-day trailing average of the Company’s closing common stock price ending on the trading day immediately prior to the funding date of the applicable Term Loan and (b) the Company’s closing common stock price on the trading day immediately prior to the funding date of the applicable Term Loan. The Warrants are immediately exercisable, and the exercise period will expire 10 years from the date of issuance. During our evaluation of equity classification for the Warrants, we considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity . The Warrants do not fall under the liability criteria within ASC 480, Distinguishing Liabilities from Equity as they are not puttable and do not represent an instrument that has a redeemable underlying security. The Warrants do meet the definition of a derivative instrument under ASC 815, but are eligible for the scope exception as they are indexed to our common stock and would be classified in permanent equity if freestanding. The Loan Agreement contains customary events of default that entitle SLR to accelerate the repayment of the Term Loans, and to exercise remedies against the Borrowers and the collateral securing the Term Loans. Upon the occurrence and for the duration of an event of default, an additional default interest rate of 4.0% will apply to all obligations owed under the Loan Agreement. In September 2022, we borrowed $30.0 million upon the signing of the Loan Agreement and incurred debt issuance costs of $3.0 million, including the exit fee of $1.4 million, that are classified as contra-liabilities on our consolidated balance sheets and are being recognized as interest expense over the term of the loan using the effective interest method. During the year ended December 31, 2022, we recognized interest expense related to the Term Loans of approximately $0.9 million, approximately $0.2 million of which was noncash expense. The following table summarizes the composition of Term Loans payable as reflected on the consolidated balance sheet as of December 31, 2022 (in thousands): December 31, 2022 Gross proceeds $ 30,000 Accrued exit fee 1,425 Unamortized debt discount (2,759) Carrying value $ 28,666 The aggregate maturities of Loan Payable as of December 31, 2022 are as follows (in thousands): December 31, 2022 2023 $ — 2024 — 2025 3,750 2026 15,000 2027 and thereafter 11,250 $ 30,000 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION 2018 Long-Term Incentive Plan We have one active stockholder-approved stock-based compensation plan, the 2018 Long-Term Incentive Plan (the “2018 Plan”). In June 2018, the 2018 Plan replaced our former 2009 Incentive Award Plan (the “2009 Plan”). Under the 2018 Plan, we may grant restricted stock awards and units, incentive and nonqualified stock options, performance unit awards, stock appreciation rights, and other stock-based awards to employees, consultants, and members of our Board of Directors. On June 21, 2022, our shareholders approved an additional 18.0 million shares to be reserved for issuance under the 2018 Plan. Stock-based awards generally vest one-third on the first anniversary of the date of grant, and in equal annual installments thereafter over the remaining two years vesting period. Stock options must generally be exercised, if at all, no later than 10 years from the date of grant. In the event of a change in control, all award types with the exception of performance unit awards granted prior to January 2023, will vest in full effective immediately prior to the consummation of the change in control. All awards issued after January 2023, unless otherwise expressly defined in executive employment agreements, shall vest at the sole discretion of the compensation committee upon a 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 approximately 39 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, 2022, 14.8 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 9.9 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 (the “Compensation Committee”), or, in the case of certain awards, issued by the Chief Executive Officer to employees, pursuant to the authority granted to the CEO by the Compensation Committee. 2022 Employment Inducement Incentive Award Plan On October 19, 2022, the Board of Directors authorized the Company’s 2022 Employment Inducement Incentive Award Plan (the “Inducement Plan”), which authorizes the Company to issue up to 5,000,000 shares of common stock of the Company pursuant to Option, Stock Appreciation Right, Restricted Stock, Restricted Stock Unit, Dividend Equivalent, and Other Stock Based Awards under the Inducement Plan (each term as defined in the Inducement Plan). The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Spectrum, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Spectrum, pursuant to Nasdaq Listing Rule 5635(c)(4). The Company has registered the Inducement Shares with the SEC pursuant to the Securities Act of 1933. As of December 31, 2022, 4.1 million shares remain available for issuance under the Inducement Plan. 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, 2022, a total of 7.5 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 and employee stock purchase plan) in the accompanying Consolidated Statements of Operations within “total operating costs and expenses” for the years ended December 31, 2022 and 2021, as follows: Year Ended December 31, 2022 2021 Selling, general and administrative $ 6,058 $ 14,644 Research and development 2,432 5,197 Total stock-based compensation $ 8,490 $ 19,841 Employee stock-based compensation expense for the years ended December 31, 2022 and 2021 was recognized (reduced for estimated forfeitures) on a straight-line basis over the vesting period. Forfeitures are estimated at the time of grant and are prospectively revised if actual forfeitures differ from those estimates. We estimate forfeitures of stock options using the historical exercise behavior of our employees. For purposes of this estimate, we have applied an estimated forfeiture rate of 10% and 11% for the years ended December 31, 2022 and 2021, 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, 2022 2021 Expected option life (in years) (a) 4.42 5.57 Risk-free interest rate (b) 1.70% - 4.42% 0.56% - 1.32% Volatility (c) 83.6% - 90.5% 80.0% - 82.7% Dividend yield (d) 0% 0% Weighted-average grant-date fair value per stock option $0.40 $1.78 (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, 2022 and 2021 was as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2020 7,656,623 $ 7.80 Granted 2,397,684 2.66 Exercised (1,250) 3.04 $ 1.5 (1) Forfeited (34,565) 10.05 Expired (513,031) 9.29 Outstanding — December 31, 2021 9,505,461 $ 6.42 Granted 6,885,316 0.68 Exercised — — $ — (1) Forfeited (1,230,311) 1.22 Expired (1,683,843) 7.65 Outstanding — December 31, 2022 13,476,623 $ 3.81 6.80 $ — (2) Expected to Vest at December 31, 2022 6,090,775 $ 1.10 9.03 $ — (2) Vested and Exercisable at December 31, 2022 6,594,608 $ 6.64 4.45 $ — (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 2022 and the stock option exercise price, multiplied by the number of in-the-money options as of December 31, 2022. 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, 2022: Outstanding Exercisable Exercise Price Granted Stock Weighted- Weighted- Granted Weighted- $0.63 - 4.96 9,809,291 7.99 $ 1.41 2,955,694 $ 2.23 $4.97 - 6.91 1,317,760 3.23 5.97 1,317,760 5.97 $6.92 - 9.00 855,991 2.19 7.74 855,991 7.74 $9.01 - 12.00 650,723 5.14 11.17 622,305 11.19 $12.01 - 22.64 842,858 4.44 18.66 842,858 18.66 13,476,623 6.80 $ 3.81 6,594,608 $ 6.64 For the years ended December 31, 2022 and 2021, we recorded stock-based compensation expense of $2.6 million and $4.5 million, respectively, related to issued stock options. As of December 31, 2022, there was unrecognized compensation expense of $3.6 million related to unvested stock options, which we expect to recognize over a weighted average period of 1.9 years. Restricted Stock Award Activity A summary of restricted stock award activity is as follows: Number of Weighted Average Unvested — December 31, 2020 4,496,045 $ 4.29 Granted 2,820,259 3.33 Vested (2,272,064) 5.06 Forfeited (608,233) 3.85 Unvested — December 31, 2021 4,436,007 3.33 Granted 2,160,240 1.20 Vested (2,025,140) 3.40 Forfeited (1,756,002) 2.23 Unvested — December 31, 2022 2,815,105 $ 2.11 For the years ended December 31, 2022 and 2021, we recorded stock-based compensation expense on our issued restricted share awards of $4.6 million and $9.6 million, respectively. As of December 31, 2022, there was approximately $3.4 million of unrecorded expense that will be recognized over an estimated weighted average period of 1.6 years. These unvested shares are included in our reported issued and outstanding common stock as of December 31, 2022. Restricted Stock Unit Activity A summary of restricted stock unit activity is as follows: Number of Weighted Average Outstanding — December 31, 2020 263,524 $ 26.39 Granted 2,125 3.61 Market-based achievement adjustment at vesting 75,000 — Share issuance (151,386) 28.09 Forfeited (4,751) 4.03 Outstanding — December 31, 2021 184,512 23.53 Granted 2,665,602 0.59 Share issuance (135,013) 0.37 Forfeited (274,539) 0.63 Outstanding — December 31, 2022 2,440,562 $ 0.63 For the years ended December 31, 2022 and 2021, we recorded stock-based compensation expense on our issued restricted stock units of $0.3 million and $1.1 million, respectively. As of December 31, 2022, there was $1.2 million of unrecorded expense that will be recognized over an estimated weighted average period of 2.4 years. Stock Appreciation Rights During the year ended December 31, 2022, no stock appreciation rights (“SARs”) were granted to our Named Executive Officers. During the year ended December 31, 2021, we granted 2.1 million 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 0.7 million forfeitures or cancellations during the year ended December 31, 2022. We recognized stock-based compensation expense of $0.6 million and $4.2 million, respectively, within our Consolidated Statements of Operations for the years ended December 31, 2022 and 2021. As of December 31, 2022, there was approximately $0.3 million of unrecorded expense that will be recognized over an estimated weighted average period of 1.1 years. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Sale of Common Stock Under ATM Agreements On April 5, 2019, we entered into a new collective at-market-issuance (“ATM”) sales agreement with Cantor Fitzgerald & Co., H.C. Wainwright & Co., LLC and B. Riley FBR, Inc. (the “April 2019 ATM Agreement”), pursuant to which we may offer and sell shares of our common stock by any method deemed to be an “at the market” offering (the “ATM Offering”). From April 5, 2019 to March 2, 2020, the ATM Offering was conducted pursuant to a sales agreement prospectus filed with our automatic shelf registration statement on Form S-3ASR, filed with the SEC on April 5, 2019, which registered an aggregate offering price of $150 million under the April 2019 ATM Agreement. From May 8, 2020 to June 30, 2020, the ATM Offering was conducted pursuant to a sales agreement prospectus (the “Initial Sales Agreement Prospectus”) filed with our shelf registration statement on Form S-3, filed with the SEC on March 20, 2020, as amended by Pre-Effective Amendment No. 1 thereto, and declared effective by the SEC on May 8, 2020 (the “Registration Statement”), which registered an aggregate offering price of up to $75 million under the April 2019 ATM Agreement. On July 29, 2020, we terminated the Initial Sales Agreement Prospectus, but left the April 2019 ATM Agreement in full force and effect. On November 6, 2020, we filed a new sales agreement prospectus to the Registration Statement, which registered an aggregate offering price of up to $60 million under the April 2019 ATM Agreement. On July 13, 2021, we filed a shelf registration statement with the SEC on Form S-3, which was declared effective by the SEC on July 21, 2021 (the “Registration Statement”). The Registration Statement registered an aggregate offering price of up to $300 million of securities that may be issued and sold by us from time to time, including up to an aggregate offering price of $150 million of common stock (which amount is included in the $300 million aggregate offering price set forth in the base prospectus) that may be issued and sold pursuant to the April 2019 ATM Agreement. The Registration Statement is effective until July 2024. As of December 31, 2022, there was approximately $128.8 million remaining to be sold pursuant to the April 2019 ATM Agreement, subject to the availability of authorized shares. 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, 2021 15,851,391 $ 52,621 Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2022 24,513,945 $ 26,561 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. Investment from Hanmi |
Financial Commitments & Conting
Financial Commitments & Contingencies and Key License Agreements | 12 Months Ended |
Dec. 31, 2022 | |
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 two We lease our principal executive office in Boston, Massachusetts under a non-cancelable operating lease expiring December 31, 2024. We also lease our administrative office in Irvine, California under a non-cancelable operating lease expiring July 31, 2025. We also leased an office facility in Henderson, Nevada under a non-cancelable operating lease which expired on October 31, 2022. 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, 2022 and 2021, we had no sublease arrangements with us as lessor, and no finance leases, as defined in ASU 2016-02, Leases (“Topic 842”). The reported asset and liability, respectively, represents (i) the economic benefit of our use of leased facilities and equipment and (ii) the present-value of our contractual minimum lease payments, applying our estimated incremental borrowing rate as of the lease commencement date (since an implicit interest rate is not readily determinable in any of our leases). The recorded asset and liability associated with each lease is amortized over the respective lease term using the effective interest rate method. During the year ended December 31, 2022 and 2021, we recognized $0.4 million and $1.8 million, respectively, of additional right-of-use assets in exchange for lease liabilities. We elected to not separate “lease components” from “non-lease components” in our measurement of minimum payments for our facility leases and office equipment leases. Additionally, we elected to not recognize a lease asset and liability for a term of 12 months or less. Financial Reporting Captions The below table summarizes the lease asset and liability accounts presented on our accompanying Consolidated Balance Sheets: Operating Leases Consolidated Balance Sheet Caption December 31, 2022 December 31, 2021 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 1,694 $ 2,505 Operating lease liabilities - current Accounts payable and other accrued liabilities $ 761 $ 1,282 Operating lease liabilities - non-current Other long-term liabilities 1,056 1,452 Total operating lease liabilities $ 1,817 $ 2,734 As of December 31, 2022 and 2021, our “facility and equipment under lease” consisted of office and research faciliti es of $1.4 million and $2.1 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, 2022 Year Ended December 31, 2021 Operating lease cost $ 1,298 $ 1,711 Variable lease cost 242 378 Short-term lease cost 47 63 Total lease cost $ 1,587 $ 2,152 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of December 31, 2022 2.5 years 3.0% Operating leases as of December 31, 2021 2.7 years 3.8% Future Contractual Lease Payments The below table summarizes our (i) minimum lease payments over the next five years, (ii) lease arrangement implied interest, and (iii) present value of future lease payments: Operating Leases - future payments December 31, 2022 2023 $ 804 2024 821 2025 188 2026 73 2027 — Total future lease payments, undiscounted $ 1,886 (Less): Implied interest (69) Present value of operating lease payments $ 1,817 (b) In/Out Licensing Agreements and Co-Development Arrangements Overview The in-license agreements for our development-stage drug products provide us with territory-specific rights to their manufacture and distribution (including further sub-licensing/out-licensing rights). We are generally responsible for all related clinical development costs, patent filings and maintenance costs, marketing costs, and liability insurance costs. We also may enter into out-license agreements for territory-specific rights to these drug products which include one or more of: upfront license fees, royalties from our licensees’ sales, and/or milestone payments from our licensees’ sales or regulatory achievements. For certain drug products, we may enter into cost-sharing arrangements with licensees and licensors. We are also obligated to make specified milestone payments to our licensors upon the achievement of certain regulatory and sales milestones, and to pay royalties based on our net sales of all in-licensed products. Depending on the milestone achievement type and whether the product has been approved, we will either (a) capitalize the value to “intangible assets” in the Consolidated Balance Sheets or (b) recognize the payment value within “research and development” or “cost of sales” on the Consolidated Statements of Operations. The liability relating to the payment due to the licensor will be recognized in the earliest period that we determine the respective milestone achievement is probable or has occurred. The most significant remaining agreements associated with our operations, along with the key financial terms and our corresponding accounting and reporting conventions for each, are as follows: (i) ROLVEDON: Co-Development and Commercialization Agreement with Hanmi In October 2014, we exercised our option under a License Option and Research Collaboration Agreement dated January 2012 (as amended) with Hanmi, which became a related party in January 2022 (see note 7), for ROLVEDON, 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 ROLVEDON development plan and hold its worldwide rights (except for Korea, China, and Japan). Effective January 1, 2022, we executed an amendment to this license agreement, whereby we are contractually obligated to pay Hanmi a flat mid-single digit royalty on our aggregate annual net sales of ROLVEDON. Additionally, Hanmi has agreed to release the Company from a prior purchase obligation for ROLVEDON drug substance which resulted in a reduction in accrued liabilities of $11.2 million with a corresponding reduction in research and development expense. In addition, beginning in year three after the commercial launch, we are responsible for a supplemental mid-single digit royalty on aggregate annual net sales. This supplemental royalty will terminate once the aggregate payments made to Hanmi meet the milestone limit of $10 million, based on the supplemental royalty. During the year ended December 31, 2022, we incurred $0.4 million in expenses with Hanmi, which are included as components of cost of sales and selling, general and administrative expenses in the consolidated statements of operations. We also purchased $9.0 million in inventory from Hanmi during the year ended December 31, 2022. As of December 31, 2022, we owed Hanmi $9.8 million, which is included as a component of accounts payable and other accrued liabilities on our consolidated balance sheet. (ii) Poziotinib: In-License Agreement with Hanmi and Exclusive Patent and Technology License Agreement with MD Anderson In February 2015, we executed an in-license agreement with Hanmi for poziotinib, a pan-HER inhibitor in Phase 2 clinical trials, (which has also shown single agent activity in the treatment of various cancer types during Phase 1 studies, including breast, gastric, colorectal, and lung cancers) and made an upfront payment to Hanmi for these distribution rights. Under the terms of this agreement, we received the exclusive global rights to commercialize poziotinib, except for Korea and China. Hanmi and its development partners are fully responsible for the completion of on-going Phase 2 trials in Korea. We are financially responsible for all other clinical studies. Effective January 1, 2022, we executed an amendment to this in-license agreement, whereby the payments to Hanmi upon our achievement of various regulatory milestones now aggregate to $18 million, which includes eliminating the first approval milestone payment in return for a supplemental mid-single digit royalty on aggregate annual net sales beginning in year three after the commercial launch. This supplemental royalty will terminate once the aggregate payments made to Hanmi meet the milestone limit of $15 million, based on the supplemental royalty. There were no contractual obligations to Hanmi for the year ended December 31, 2022. In April 2018, we executed an exclusive patent and technology agreement for the use of poziotinib in treating patients with EGFR and HER2 exon 20 mutations in cancer and HER2 exon 19 mutations in cancer with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”). MD Anderson discovered poziotinib’s use in treating these patient-types. We made an upfront payment to MD Anderson of $0.5 million upon the execution of this agreement. We are contractually obligated to pay nominal fixed annual license maintenance fees to MD Anderson and pay additional fees upon our achievement of various regulatory and sales milestones. These regulatory milestones aggregate $6 million and the sales milestones aggregate $24 million. We are also contractually obligated to pay MD Anderson royalties in the low single-digits on our net sales of poziotinib. (iii) In-License Agreement with ImmunGene for FIT Drug Delivery Platform In April 2019, we executed an asset transfer, license, and sublicense agreement with ImmunGene, Inc. (“ImmunGene”) for an exclusive license for the intellectual property related to (a) Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma patients, representing a considerable unmet medical need, and (b) an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies that have the potential for treating both solid and hematologic malignancies. Both molecules are based on the Focused Interferon Therapeutics (“FIT”) drug delivery platform. In November 2021, we provided notice to terminate the asset transfer, license, and sublicense agreement with ImmunGene, Inc. Pursuant to the agreement, we will transfer the rights, title or interest with respect to the transferred product back to ImmunGene. There were no contractual obligations to ImmunGene for the twelve months ended December 31, 2022. As of December 31, 2022 we are no longer prosecuting or maintaining any ImmunGene intellectual property and we are not contractually obligated to pay nominal fixed annual license maintenance fees to any ImmunGene-related licensor. (iv) In-License Agreement with Therapyx In December 2020, we executed an asset transfer and license agreement with Therapyx, Inc. (“Therapyx”) for an exclusive worldwide license for the intellectual property related to any pharmaceutical or biological product for use in human oncology containing, whether as its sole active or in combination with other active ingredients, an encapsulated IL-12, in any injectable dosage form or formulation. We made an upfront payment of $0.8 million to Therapyx upon contract execution, which was recorded to “research and development” expense within our Consolidated Statements of Operations for the year ended December 31, 2020. We will make an additional payment of $2.2 million upon our acceptance of certain transferred materials from Therapyx. We will make further payments to Therapyx upon our achievement of various (i) regulatory milestones aggregating up to $30 million for the first approved IL-12 product, plus an additional $2.5 million milestone payment for each new indication approved for each product in the U.S., Europe, or Japan; and (ii) sales milestones aggregating up to $167.5 million based on worldwide annual net sales. We are contractually obligated to pay royalties in the mid-single digits on our net sales of all IL-12 products, potentially reduced by royalties due to third parties, the loss of IP protection within one or more countries, or the introduction of a competing product within one or more countries. Depending on the nature of the milestone achievement type we will either (a) capitalize the payment value to “intangible assets” in the Consolidated Balance Sheets or (b) recognize the payment value within “research and development” or “cost of sales” within the Consolidated Statements of Operations. The corresponding liability for the payment due to this licensor will be recognized in the Consolidated Balance Sheets within “accounts payable and other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or has occurred. (c) Service Agreements for Research and Development Activities We have entered into various contracts with numerous third-party service providers for the execution of our research and development initiatives. These vendors include raw material suppliers, clinical trial sites, clinical research organizations, and data monitoring centers, among others. The financial terms of these agreements are varied and generally obligate us to pay in stages, depending on the achievement of certain events specified in the agreements - such as contract execution, progress of service completion, delivery of drug supply, and the dosing of patients in clinical studies. We recognize these “research and development” expenses and corresponding “accounts payable and other accrued liabilities” in the accompanying financial statements based on estimates of our vendors’ progress of performed services, patient enrollments and dosing, completion of clinical studies, and other events. Should we decide to discontinue and/or slow-down the work on any project, the associated costs for those projects would typically be limited to the extent of the work completed, as we are generally able to terminate these contracts with adequate notice. (d) Supply and Service Agreements Associated with Product Production We have various product supply agreements and/or have issued vendor purchase orders that obligate us to agreed-upon raw material purchases from certain vendors. We also have certain drug production service agreements with select contract manufacturers that obligate us to service fees during the contractual period. (e) Employment Agreements We entered into revised employment agreements with certain of our named executive officers (chief executive officer and chief legal officer) in April/June 2018, which supersede any prior change in control severance agreements with such individuals. We entered into an employment agreement with our chief financial officer in April 2022. These agreements provide for the payment of certain benefits to each executive upon their separation of employment under specified circumstances. These arrangements are designed to encourage each to act in the best interests of our stockholders at all times during the course of a change in control event or other significant transaction. We previously entered into an employment agreement with our former Chief Executive Officer, Joseph Turgeon, under which cash compensation and benefits would become payable in the event of termination by us for any reason other than cause, his resignation for good reason, or upon a change in control of our Company. Effective December 31, 2021, Mr. Turgeon’s employment with the Company was terminated without cause in accordance with his employment agreement. We accrued $3.1 million for all contractual amounts due and unpaid to Mr. Turgeon as of December 31, 2021, within "accrued payroll and benefits" on the accompanying Consolidated Balance Sheets. The amount was paid in its entirety in 2022. (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 matched a fixed percentage of these deferrals and may make additional discretionary contributions. At December 31, 2022 and 2021, the aggregate value of this DC Plan liability was $4.5 million and $11.2 million, respectively, and is included within “accounts payable and other accrued liabilities” and “other long-term liabilities” in the accompanying 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. Stockholder Actions Luo v. Spectrum Pharmaceuticals, Inc., et al. , U.S. District Court, District of Nevada, Case No. 2:21-cv-01612. On August 31, 2021, this putative securities class action lawsuit was filed by a purported shareholder, alleging that we and certain of our current and former executive officers and directors made false or misleading statements and failed to disclose material facts about our business and the prospects of approval for our BLA to the FDA for eflapegrastim (ROLVEDON) in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934. On November 1, 2021, four individuals and one entity filed competing motions to be appointed lead plaintiff and for approval of counsel. On July 28, 2022, the Court appointed a lead plaintiff and counsel for the putative class. On September 26, 2022, an amended complaint was filed alleging, inter alia, false and misleading statements with respect to ROLVEDON manufacturing operations and controls and added allegations that defendants misled investors about the efficacy of, clinical trial data and market need for Poziotinib between a Class Period of March 7, 2018 and August 5, 2021. The amended complaint seeks damages, interest, costs, attorneys’ fees, and such other relief as determined by the Court. On November 30, 2022, we filed a motion to dismiss the amended complaint, which motion is pending. There is no hearing date presently scheduled. Three additional related putative securities class action lawsuits were subsequently filed by shareholders against us in the U.S. District Court for the Southern District of New York: Osorio-Franco v. Spectrum Pharmaceuticals, Inc., et al., Case No. 1:22-cv-10292 (filed December 5, 2022); Cummings v. Spectrum Pharmaceuticals, Inc., et al., Case No. 1:22-cv-10677 (filed December 19, 2022); and Carneiro v. Spectrum Pharmaceuticals, Inc., et al., Case No. 1:23-cv-00767 (filed January 30, 2023). These three New York lawsuits allege that we and certain of our executive officers and directors made false or misleading statements about, inter alia, the safety and efficacy of and clinical trial data for Poziotinib in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934, and seek remedies including damages, interest, costs, attorneys’ fees, and such other relief as determined by the Court. The Osorio-Franco and Cummings lawsuits allege Class Periods between December 6, 2021 and September 22, 2022. The Carneiro lawsuit alleges a Class Period between July 27, 2020 and September 22, 2022, which overlaps with the Luo action Class Period. On February 15, 2023, the Court consolidated the three New York lawsuits, with Osorio-Franco as the lead case. We believe that all of the putative securities class action lawsuit claims are without merit and intend to vigorously defend against these claims. Csaba v. Turgeon, et. al , (filed December 15, 2021 in the U.S. District Court District of Nevada); Shumacher v. Turgeon, et. al, (filed March 15, 2022 in the U.S. District Court District of Nevada); Johnson v. Turgeon, et. al, (filed March 29, 2022 in the U.S. District Court District of Nevada); Raul v. Turgeon, et. al, (filed April 28, 2022 in the U.S. District Court District of Delaware); and Albayrak v. Turgeon, et al, (filed June 9, 2022 in the U.S. District Court District of Nevada). These putative stockholder derivative actions were filed against us (as a nominal defendant), certain of our executive officers, and certain of our past and present members of the board of directors. The stockholder derivative complaints allege, inter alia, that certain of our executive officers are liable to Spectrum, pursuant to Section 10(b) and 21D of the Securities Exchange Act of 1934, as amended, for contribution and indemnification, if they are deemed (in the Luo class action), to have made false or misleading statements and failed to disclose material facts about our business and the prospects of approval for our BLA to the FDA for eflapegrastim. The complaints generally but not uniformly further allege that certain of our executive officers and certain of our past and present directors breached their fiduciary duties, and certain of our present directors negligently violated Section 14(a) of the Exchange Act, by allegedly causing such false or misleading statements to be issued and/or failing to disclose material facts about our business and the prospects of approval for our BLA to the FDA for eflapegrastim. The allegations state that as a result of the violations, certain of our executive officers and past and present board members committed acts of gross mismanagement, abuse of control, or were unjustly enriched. The plaintiffs generally seek corporate reforms, damages, interest, costs, attorneys’ fees, and other unspecified equitable relief. The parties have agreed to stay all derivative actions until there is an adverse decision on a motion to dismiss in the Luo Nevada securities class action. We believe that the derivative actions are without merit and intend to vigorously defend against these claims. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 United States $ (78,126) $ (158,552) Foreign 68 120 Total $ (78,058) $ (158,432) The provision for income taxes from continuing operations consist of the following: Year Ended December 31, 2022 2021 Current: Federal $ — $ — State — — Foreign 46 4 $ 46 $ 4 Deferred: Federal — — State — — Foreign — — — — Total income tax expense $ 46 $ 4 For the fiscal year ended December 31, 2022, we generated losses from continuing operations and recognized $46 thousand of tax expense from our foreign continuing operations. The income tax expense 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, 2022 2021 Tax provision computed at the federal statutory rate $ (16,392) $ (33,210) State tax, net of federal benefit (2,913) (11,050) Research and development expense tax credits (328) (1,838) Officers compensation (738) 1,988 Stock based compensation 2,688 1,234 Permanent items and other 157 (173) Change in tax rate 3,288 (6,671) Change in prior year deferred taxes 568 (353) Valuation allowance 13,716 50,077 Income tax expense $ 46 $ 4 Significant components of our deferred tax assets and liabilities as of December 31, 2022 and 2021 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, 2022 2021 Deferred tax assets: Net operating loss carry forwards $ 198,162 $ 187,129 Research and development expense tax credits 27,669 27,341 Stock based compensation 4,136 5,470 Lease obligation 456 783 ROLVEDON supplies 9,337 — Returns and allowances 636 1,198 Amortization differences 857 1,749 Capitalized research and development expenses 12,218 — Other, net 3,114 20,610 Total deferred tax assets before valuation allowance 256,585 244,280 Valuation allowance (256,063) (242,590) Total deferred tax assets 522 1,690 Deferred tax liabilities, net: Unrealized gains (97) (973) Right-of-use asset (425) (717) Net deferred tax liabilities $ — $ — At December 31, 2022 and 2021, we recorded a valuation allowance of $256.1 million and $242.6 million, respectively. The valuation allowance increased by $13.5 million and $50.1 million during 2022 and 2021, respectively. The increases in the valuation allowance in 2022 and 2021 were mostly due to an increase in net operating loss carryforwards. The $13.5 million increase in valuation allowance in 2022 is comprised of a $13.7 million increase from losses in continuing operations net of a $0.2 million decrease from income in discontinued operations. At December 31, 2022, we had federal and state net operating loss carryforwards of approximately $789.3 million and $603.4 million, 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 expiring in 2022 unless previously utilized. Federal loss carryforwards generated in 2018 and beyond of $510.7 million will be carried forward indefinitely. At December 31, 2022, we had federal and state tax credits of approximately $19.0 million and $11.0 million, respectively. The federal tax credit carryovers begin to expire in 2027 unless previously utilized. The state 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 2013, 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, 2022 2021 Balance at beginning of year $ 3,524 $ 3,336 Adjustments related to prior year tax positions — (318) Increases related to current year tax positions 102 506 Balance at end of year $ 3,626 $ 3,524 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, 2022 and 2021, 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 2018. In addition, the utilization of net loss carryforwards is subject to federal and state adjustment for the periods in which those net losses were incurred. Our policy is to recognize interest and/or penalties related to unrecognized tax benefits in income tax expense in the Consolidated Statements of Operations. |
Discontinued Operations
Discontinued Operations | 12 Months Ended |
Dec. 31, 2022 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | DISCONTINUED OPERATIONS Overview In March 2019 we completed the sale of our seven then-commercialized drugs (the “Commercial Product Portfolio”) to Acrotech in the Commercial Product Portfolio Transaction. Upon closing we received $158.8 million in an upfront cash payment. We are also entitled to receive up to an aggregate of $140 million upon Acrotech’s future achievement of certain regulatory milestones (totaling $40 million) and sales-based milestones (totaling $100 million) relating to the Commercial Product Portfolio. Substantially all of the contractual rights and obligations associated with the Commercial Product Portfolio were transferred to Acrotech at the closing of the Commercial Product Portfolio Transaction. However, under the terms of this transaction we retained our trade “accounts receivable, net” and GTN liabilities included within “accounts payable and other accrued liabilities” associated with our product sales made on and prior to February 28, 2019. Accordingly, these Consolidated Financial Statements reflect the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations”. Consolidated Statements of Operations The following table presents the various elements of “income (loss) from discontinued operations, net of income taxes” as reported in the accompanying Consolidated Statements of Operations: Year ended December 31, 2022 2021 Revenues: Product sales, net (1) $ 2,739 $ — Total revenues $ 2,739 $ — Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) 5 133 Selling, general and administrative — — Research and development 31 59 Total operating costs and expenses $ 36 $ 192 Income (loss) from discontinued operations before income taxes 2,703 (192) Provision for income taxes from discontinued operations — — Income (loss) from discontinued operations, net of income taxes $ 2,703 $ (192) (1) Product sales, net for the year ended December 31, 2022 resulted from a reversal of GTN accruals that contractually expired and for which we are no longer liable. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTSDuring January 2023 and through the date of this filing, we sold and issued 2.0 million shares of our common stock for net proceeds of approximately $1.8 million under the April 2019 ATM Agreement.The Employee Retention Credit (“ERC”) under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) is a refundable tax credit which encouraged businesses to keep employees on the payroll during the COVID-19 pandemic. The ERC was applied for based on delays in the FDA approval process for ROLVEDON. In January 2023, we received $1.2 million ERCs. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2022 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Use of Estimates (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Description of Business | Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum,” the “Company,” “we,” “our,” or “us”) is a commercial-stage biopharmaceutical company, with a strategy of acquiring, developing, and commercializing novel and targeted oncology therapies. We have an in-house clinical development organization with regulatory and data management capabilities, in addition to commercial infrastructure and a field based sales force for our marketed product, ROLVEDON™ (formerly known as eflapegrastim). We have one commercial asset and one drug candidate in late-stage development: • ROLVEDON ™ is a novel long-acting granulocyte colony-stimulating factor (“G-CSF”) for the treatment of chemotherapy-induced neutropenia. On April 11, 2022, we announced that we had received notice that the Biologics License Application (“BLA”) for ROLVEDON had been accepted for filing and received a Prescription Drug User Fee Act (“PDUFA”) date of September 9, 2022. On September 9, 2022, we received the U.S. Food and Drug Administration’s (“FDA”) marketing approval for ROLVEDON and began commercialization activities in the fourth quarter of 2022; and • Poziotinib is a novel irreversible TKI under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations. On December 6, 2021, we announced we submitted our New Drug Application (“NDA”) for poziotinib to the FDA for use in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations. The NDA submission is based on the positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib. The product candidate received fast track designation from the FDA and there is currently no treatment specifically approved by the FDA for this indication. On February 11, 2022, we announced that we received notice from the FDA that the NDA was accepted for filing and received a PDUFA action date of November 24, 2022. On September 22, 2022, we met with the FDA’s Oncologic Drugs Advisory Committee (“ODAC”). The ODAC voted 9 (no) - 4 (yes) that the current benefits of poziotinib did not outweigh its risks for the treatment of patients with NSCLC with HER2 exon 20 insertion mutations. On November 25, 2022, we announced that we had received a Complete Response Letter (“CRL”) from the FDA regarding our NDA. The CRL stated that the FDA determined that it could not approve the NDA in its present form and provided recommendations needed for resubmission, including generating additional data from a randomized controlled study prior to approval. We are continuing to evaluate these recommendations but we have de-prioritized further poziotinib development activities. Our business strategy is the development of late-stage assets through commercialization and the sourcing of additional assets that are synergistic with our existing portfolio (through purchase acquisitions, in-licensing transactions, or co-development and marketing arrangements). |
Basis of Presentation | Basis of Presentation 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 consolidated financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. Substantially all of the accumulated other comprehensive loss is comprised of foreign currency translation adjustments at December 31, 2022. The consolidated financial statements have been prepared on a going concern basis, which assumes that the Company will continue in operational existence for the foreseeable future. Foreign Currency Translation Operations in non-U.S. entities are recorded in the functional currency of each entity. For financial reporting purposes, the functional currency of an entity is determined by a review of the source of an entity's most predominant cash flows. The results of operations for any non-U.S. dollar functional currency entities are translated from functional currencies into U.S. dollars using the average currency rate during each month. Assets and liabilities are translated using currency rates at the end of the period. Adjustments resulting from translating the financial statements of our foreign entities that use their local currency as the functional currency into U.S. dollars are reflected as a component of other comprehensive income (loss). Transaction gains and losses are recorded in other income (expense), net, in the consolidated statements of operations. Discontinued Operations - Sale of our Commercial Product Portfolio In March 2019, we completed the sale of our Commercial Product Portfolio (as defined below in Note 10 ) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). In accordance with applicable GAAP ( Accounting Standards Codification, “ASC”, 205-20, Presentation of Financial Statements ), the revenue-deriving activities and allocable expenses of our sold commercial operations, connected to the Commercial Product Portfolio, are separately classified as “discontinued” for all periods presented within the accompanying Consolidated Statements of Operations. Liquidity and Capital Resources |
Operating Segment | Operating SegmentWe operate one reportable operating segment that is focused exclusively on developing and marketing oncology and hematology drug products. For the years ended December 31, 2022 and 2021, all of our operating costs and expenses were solely attributable to these activities (and as applicable, classified as “discontinued” within the accompanying Consolidated Statements of Operations). |
Use of Estimates and Assumptions | The preparation of financial statements in conformity with GAAP requires our management to make informed estimates and assumptions that affect our reported amounts of assets, liabilities, revenues, and expenses. These amounts may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. On an on-going basis, our management evaluates (as applicable) its most critical estimates and assumptions, including those described below: |
Revenue Recognition | Revenue RecognitionWe recognize ROLVEDON revenue in accordance with ASC 606 – Revenue from contracts with customers. Our revenue recognition analysis consists of the following steps: (i) identification of the promised goods in the contract; (ii) determination of whether the promised goods are performance obligations, including whether they are capable of being distinct; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue as we satisfy each performance obligation. ROLVEDON became available for commercial sale and shipment to patients with a prescription in the U.S. in the fourth quarter of 2022. We sell our products to pharmaceutical wholesalers/distributors (i.e., our customers) who in turn sell our products directly to clinics, hospitals, and federal healthcare programs. 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. The transaction price that we recognize for ROLVEDON revenue is our gross product sales reduced by our corresponding gross-to-net (“GTN”) estimates using the expected value method, resulting in our reported “net sales” in the accompanying Consolidated Statements of Operations. Net sales 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 GPO administrative fees may be above or below the amount estimated, then requiring prospective adjustments to our reported net sales. These GTN estimate categories (that comprise our GTN liabilities) are each discussed below: Product Returns Allowances : Our customers are contractually permitted to return certain purchased products within the contractual allowable time before/after the applicable expiration date. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns using our expected return rates. Returned product is typically destroyed since substantially all are due to imminent expiry and cannot be resold. Government Chargebacks : Our product is subject to pricing limits under certain federal government programs (e.g., Medicare, Medicaid, 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 product is 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 of similar products 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. |
Cash and Cash Equivalents | Cash and Cash EquivalentsCash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. |
Marketable Securities | Marketable SecuritiesMarketable securities consist of our holdings in equity securities (including mutual funds), bank CDs, government-related debt securities, and corporate debt securities. For equity securities and mutual funds, any realized or unrealized gains (losses) are recognized in “other income (expense), net” within the Consolidated Statements of Operations. Debt securities and bank CDs are classified as “available-for-sale” investments and (1) realized gains (losses) are recognized in “other income (expense), net” within the Consolidated Statements of Operations and (2) unrealized gains (losses) are recognized as a component of “accumulated other comprehensive loss” within the Consolidated Statements of Stockholders’ Equity. |
Accounts Receivable, net | Accounts Receivable, netIn general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns and chargebacks. As of December 31, 2022, these allowances amounted to $1.3 million. Our contracts with customers have standard payment terms. As of December 31, 2022, the majority of our sales were to the top three wholesalers. We analyze accounts that are past due for collectability, and regularly evaluate the creditworthiness of our customers so that we can properly assess and respond to changes in their credit profiles. As of December 31, 2022, we determined an allowance for expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances. |
Inventory | Inventory We value our inventory at the lower of cost or net realizable value. Inventory cost is determined on a first-in, first-out basis. We regularly review our inventory quantities and when appropriate record a provision for obsolete and excess inventory to derive its new cost basis, which takes into account our sales forecast and corresponding expiry dates. We have not recognized a provision for obsolete and excess inventory as of December 31, 2022. We received FDA approval for ROLVEDON on September 9, 2022, and on that date began capitalizing inventory purchases of saleable product from certain suppliers. Prior to FDA approval, all saleable product purchased from such suppliers were included as a component of research and development expense, as we were unable to assert that the inventory had future economic benefit until we had received FDA approval. Prior to FDA approval, costs estimated at approximately $5.7 million for commercially saleable product and materials were incurred and included in research and development expenses. If we were to have included those costs previously expensed as a component of cost of sales, our cost of sales for the year ended December 31, 2022 would have been $3.0 million. As a result, cost of sales related to ROLVEDON will initially reflect a lower average per unit cost of materials over the next approximately nine months as previously expensed inventory is utilized for commercial production and sold to customers. |
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 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. |
Cost of Sales | Cost of SalesCost of sales includes the cost of the inventory sold, which includes direct manufacturing, production and packaging materials, shipping expenses, and royalty fees owed to our licensing partner for ROLVEDON sales. Prior to FDA approval in September 2022, we expensed approximately $5.7 million in costs associated with the manufacturing of ROLVEDON as a component of research and development expense. Therefore these costs are not included in cost of sales. |
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, and 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. The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires certain 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), (d) zero dividend yield, and (e) the prevailing risk-free interest rate for the period matching the expected term. With regard to (a)-(e) 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 and we estimate a zero dividend yield. Due to the inherent uncertainty of these estimates, the actual amounts incurred may be above or below the amount estimated, then requiring prospective adjustments to our stock-based compensation expense. |
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 is the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only stock options, warrants, and other common stock equivalents outstanding during the period to the extent that they are dilutive. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. Our effective tax rate differs from the U.S. federal statutory tax rate primarily as a result of nondeductible expenses and the impact of a valuation allowance on our deferred tax assets, which we record because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income or reduce our net loss 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 “provision for income taxes from continuing operations” within the accompanying Consolidated Statements of Operations for the period in which we received the notice. |
Research and Development Expenses | Research and Development ExpensesOur research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, benefits, and other staff-related costs including associated stock-based compensation, laboratory supplies, clinical trial and related clinical manufacturing costs, costs related to manufacturing preparations, fees paid to other entities that conduct certain research and development activities on our behalf and payments made pursuant to license agreements. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. We accrue for costs incurred as the services are being provided by monitoring the status of activities and the invoices received from our external service providers. We adjust our accruals as actual costs become known. Where contingent milestone payments are due to third parties under research and development or license agreements, the milestone payment obligations are expensed in the earliest period that we determine the respective milestone achievement is probable or has occurred. |
Debt Issuance Costs | Debt Issuance Costs Debt issuance costs incurred in connection with the Term Loan is classified on the consolidated balance sheet as a direct deduction from the carrying amount of the related debt liability. These expenses are deferred and amortized as part of interest expense in the consolidated statement of operations using the effective interest rate method over the term of the debt agreement. Refer to Note 5 for additional information on the Term Loan. |
Fair Value Measurements | Fair Value Measurements We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. Level 3: Unobservable inputs are used when little or no market data is available. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In June 2022, the FASB issued Accounting Standards Update No. 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard becomes effective for us on January 1, 2024, and is not expected to have a material impact on our consolidated financial statements and related disclosures. There are several other new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”), which we do not believe had or will have a material impact on our consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 36,298 $ — $ — $ 36,298 Equity securities 136 — — 136 Government-related debt securities 30,348 — — 30,348 Mutual funds 4,244 8 — 4,252 $ 71,026 $ 8 $ — $ 71,034 Liabilities: Deferred executive compensation liability (1) $ — $ 4,531 $ — $ 4,531 $ — $ 4,531 $ — $ 4,531 (1) Included $1.5 million within accounts payable and other accrued liabilities and $3.0 million within other long-term liabilities on our Consolidated Balance Sheets. December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Equity securities $ 5,718 $ — $ — $ 5,718 Money market funds 66,322 — — 66,322 Mutual funds 6,390 9 — 6,399 Key employee life insurance, cash surrender value (1) — 4,507 — 4,507 $ 78,430 $ 4,516 $ — $ 82,946 Liabilities: Deferred executive compensation liability (2) $ — $ 11,243 $ — $ 11,243 $ — $ 11,243 $ — $ 11,243 (1) Included within other assets on our Consolidated Balance Sheets, and the amount is based on the stated cash surrender value of life insurance policies of named current and former employees at each period-end. |
Balance Sheet Account Detail (T
Balance Sheet Account Detail (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Cash and Cash Equivalents and Marketable Securities | The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Fair Value Cash and Cash Marketable Securities December 31, 2022 Money market funds $ 36,298 $ 36,298 $ 36,298 $ — Equity securities (1) — 136 — 136 Government-related debt securities 30,359 30,348 — 30,348 Mutual funds 3,395 4,244 — 4,244 Bank deposits 4,070 4,070 4,070 — Total cash and cash equivalents and marketable securities $ 74,122 $ 75,096 $ 40,368 $ 34,728 December 31, 2021 Money market funds $ 66,322 $ 66,322 $ 66,322 $ — Equity securities 3,512 5,718 — 5,718 Mutual funds 5,218 6,390 — 6,390 Bank deposits 22,217 22,217 22,217 — Total cash and cash equivalents and marketable securities $ 97,269 $ 100,647 $ 88,539 $ 12,108 (1) Our aggregate equity holdings consist of 0.3 million common shares of Unicycive Therapeutics, Inc., a NASDAQ-listed biopharmaceutical company, with a fair market value of $0.1 million as of December 31, 2022. We completed the sale of 0.6 million shares of common stock and recognized a $0.5 million gain within “other expense, net” within the accompanying Consolidated Statements of Operations for the year ended December 31, 2022. Additionally, we completed the sale of our remaining 0.9 million shares of CASI Pharmaceuticals, Inc., a NASDAQ-listed biopharmaceutical company, and recognized a $1.9 million loss within “other expense, net” within the accompanying Consolidated Statements of Operations for the year ended December 31, 2022. We no longer hold any shares of CASI Pharmaceuticals, Inc. |
Schedule of Inventories | Upon approval of ROLVEDON on September 9, 2022, we began capitalizing our purchases of saleable inventory of ROLVEDON from suppliers. Inventories consist of the following: December 31, 2022 2021 Raw materials $ 4,500 $ — Work-in-process 4,007 — Finished goods 723 — Inventories $ 9,230 $ — |
Schedule of Accounts Payable and Other Accrued Liabilities | “Accounts payable and other accrued liabilities” consists of the following, with “Product revenue allowances – ROLVEDON” being as of and for the year ended December 31, 2022: December 31, 2022 2021 Trade accounts payable and other $ 30,547 $ 33,408 Lease liability - current portion 761 1,282 Product revenue allowances - ROLVEDON 3,082 — Commercial Product Portfolio accruals (Note 10) 3,715 6,568 Accounts payable and other accrued liabilities $ 38,105 $ 41,258 |
Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities | Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Consolidated Balance Sheets for our categories of gross-to-net (“GTN”) estimates related to discontinued operations (Commercial Product Portfolio) accruals were as follows: Commercial/Medicaid Rebates and Government Chargebacks Distribution, Product Return Allowances Total Balance as of December 31, 2020 $ 2,601 $ 942 $ 4,299 $ 7,842 (Less): Payments and credits against GTN accruals (1,159) — (115) (1,274) Balance as of December 31, 2021 1,442 942 4,184 6,568 (Less): Payment and credits against GTN accruals (5) 93 (203) (115) (Less): Release of GTN accruals (117) (871) (1,750) (2,738) Balance as of December 31, 2022 $ 1,320 $ 164 $ 2,231 $ 3,715 |
Loan Payable (Tables)
Loan Payable (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Term Loan Payable of Debt | The following table summarizes the composition of Term Loans payable as reflected on the consolidated balance sheet as of December 31, 2022 (in thousands): December 31, 2022 Gross proceeds $ 30,000 Accrued exit fee 1,425 Unamortized debt discount (2,759) Carrying value $ 28,666 |
Schedule of Maturities of Long-Term Debt | The aggregate maturities of Loan Payable as of December 31, 2022 are as follows (in thousands): December 31, 2022 2023 $ — 2024 — 2025 3,750 2026 15,000 2027 and thereafter 11,250 $ 30,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense | We report our stock-based compensation expense (inclusive of our incentive stock plan and employee stock purchase plan) in the accompanying Consolidated Statements of Operations within “total operating costs and expenses” for the years ended December 31, 2022 and 2021, as follows: Year Ended December 31, 2022 2021 Selling, general and administrative $ 6,058 $ 14,644 Research and development 2,432 5,197 Total stock-based compensation $ 8,490 $ 19,841 |
Schedule of Fair Value of Stock Options Granted Using Black-Scholes Option Pricing Model | The fair value of stock options granted was estimated at the date of grant using the Black-Scholes option-pricing model. The following assumptions were used to determine fair value for the stock awards granted in the applicable year: Year Ended December 31, 2022 2021 Expected option life (in years) (a) 4.42 5.57 Risk-free interest rate (b) 1.70% - 4.42% 0.56% - 1.32% Volatility (c) 83.6% - 90.5% 80.0% - 82.7% Dividend yield (d) 0% 0% Weighted-average grant-date fair value per stock option $0.40 $1.78 (a) Determined by the historical stock option exercise behavior of our employees (maximum term is 10 years). (b) Based upon the U.S. Treasury yields in effect during the period which the options were granted (for a period equaling the stock options’ expected term). (c) Measured using our historical stock price for a period equal to stock options’ expected term. (d) We do not expect to declare any cash dividends in the foreseeable future. |
Schedule of Stock Option Activity | Stock option activity during the years ended December 31, 2022 and 2021 was as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2020 7,656,623 $ 7.80 Granted 2,397,684 2.66 Exercised (1,250) 3.04 $ 1.5 (1) Forfeited (34,565) 10.05 Expired (513,031) 9.29 Outstanding — December 31, 2021 9,505,461 $ 6.42 Granted 6,885,316 0.68 Exercised — — $ — (1) Forfeited (1,230,311) 1.22 Expired (1,683,843) 7.65 Outstanding — December 31, 2022 13,476,623 $ 3.81 6.80 $ — (2) Expected to Vest at December 31, 2022 6,090,775 $ 1.10 9.03 $ — (2) Vested and Exercisable at December 31, 2022 6,594,608 $ 6.64 4.45 $ — (2) (1) Represents the total difference between our closing stock price at the time of exercise and the stock option exercise price, multiplied by the number of options exercised. |
Schedule of Stock Option Grants | The following table summarizes information with respect to stock option grants as of December 31, 2022: Outstanding Exercisable Exercise Price Granted Stock Weighted- Weighted- Granted Weighted- $0.63 - 4.96 9,809,291 7.99 $ 1.41 2,955,694 $ 2.23 $4.97 - 6.91 1,317,760 3.23 5.97 1,317,760 5.97 $6.92 - 9.00 855,991 2.19 7.74 855,991 7.74 $9.01 - 12.00 650,723 5.14 11.17 622,305 11.19 $12.01 - 22.64 842,858 4.44 18.66 842,858 18.66 13,476,623 6.80 $ 3.81 6,594,608 $ 6.64 |
Schedule of Restricted Stock Award and Restricted Stock Units Activity | A summary of restricted stock award activity is as follows: Number of Weighted Average Unvested — December 31, 2020 4,496,045 $ 4.29 Granted 2,820,259 3.33 Vested (2,272,064) 5.06 Forfeited (608,233) 3.85 Unvested — December 31, 2021 4,436,007 3.33 Granted 2,160,240 1.20 Vested (2,025,140) 3.40 Forfeited (1,756,002) 2.23 Unvested — December 31, 2022 2,815,105 $ 2.11 Number of Weighted Average Outstanding — December 31, 2020 263,524 $ 26.39 Granted 2,125 3.61 Market-based achievement adjustment at vesting 75,000 — Share issuance (151,386) 28.09 Forfeited (4,751) 4.03 Outstanding — December 31, 2021 184,512 23.53 Granted 2,665,602 0.59 Share issuance (135,013) 0.37 Forfeited (274,539) 0.63 Outstanding — December 31, 2022 2,440,562 $ 0.63 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2021 15,851,391 $ 52,621 Common shares issued pursuant to the April 2019 ATM Agreement during the year ended December 31, 2022 24,513,945 $ 26,561 |
Financial Commitments & Conti_2
Financial Commitments & Contingencies and Key License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Lease Assets and Liabilities | The below table summarizes the lease asset and liability accounts presented on our accompanying Consolidated Balance Sheets: Operating Leases Consolidated Balance Sheet Caption December 31, 2022 December 31, 2021 Operating lease right-of-use assets - non-current Facility and equipment under lease $ 1,694 $ 2,505 Operating lease liabilities - current Accounts payable and other accrued liabilities $ 761 $ 1,282 Operating lease liabilities - non-current Other long-term liabilities 1,056 1,452 Total operating lease liabilities $ 1,817 $ 2,734 |
Schedule of Aggregate Lease Expense | The components of our aggregate lease expense is summarized below: Year Ended December 31, 2022 Year Ended December 31, 2021 Operating lease cost $ 1,298 $ 1,711 Variable lease cost 242 378 Short-term lease cost 47 63 Total lease cost $ 1,587 $ 2,152 Weighted Average Remaining Lease Term and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of December 31, 2022 2.5 years 3.0% Operating leases as of December 31, 2021 2.7 years 3.8% |
Schedule of Future Contractual Lease Payments | The below table summarizes our (i) minimum lease payments over the next five years, (ii) lease arrangement implied interest, and (iii) present value of future lease payments: Operating Leases - future payments December 31, 2022 2023 $ 804 2024 821 2025 188 2026 73 2027 — Total future lease payments, undiscounted $ 1,886 (Less): Implied interest (69) Present value of operating lease payments $ 1,817 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Loss before Benefit for Income Taxes | The components of loss before benefit for income taxes from continuing operations are as follows: Year Ended December 31, 2022 2021 United States $ (78,126) $ (158,552) Foreign 68 120 Total $ (78,058) $ (158,432) |
Schedule of Provision for Income Taxes | The provision for income taxes from continuing operations consist of the following: Year Ended December 31, 2022 2021 Current: Federal $ — $ — State — — Foreign 46 4 $ 46 $ 4 Deferred: Federal — — State — — Foreign — — — — Total income tax expense $ 46 $ 4 |
Schedule of Income Tax Expense Reconciliation | The income tax expense 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, 2022 2021 Tax provision computed at the federal statutory rate $ (16,392) $ (33,210) State tax, net of federal benefit (2,913) (11,050) Research and development expense tax credits (328) (1,838) Officers compensation (738) 1,988 Stock based compensation 2,688 1,234 Permanent items and other 157 (173) Change in tax rate 3,288 (6,671) Change in prior year deferred taxes 568 (353) Valuation allowance 13,716 50,077 Income tax expense $ 46 $ 4 |
Schedule of Components of Deferred Tax Assets and Liabilities | Significant components of our deferred tax assets and liabilities as of December 31, 2022 and 2021 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, 2022 2021 Deferred tax assets: Net operating loss carry forwards $ 198,162 $ 187,129 Research and development expense tax credits 27,669 27,341 Stock based compensation 4,136 5,470 Lease obligation 456 783 ROLVEDON supplies 9,337 — Returns and allowances 636 1,198 Amortization differences 857 1,749 Capitalized research and development expenses 12,218 — Other, net 3,114 20,610 Total deferred tax assets before valuation allowance 256,585 244,280 Valuation allowance (256,063) (242,590) Total deferred tax assets 522 1,690 Deferred tax liabilities, net: Unrealized gains (97) (973) Right-of-use asset (425) (717) Net deferred tax liabilities $ — $ — |
Schedule of Unrecognized Tax Benefits | The following tabular reconciliation summarizes the activity related to our unrecognized tax benefits: Year Ended December 31, 2022 2021 Balance at beginning of year $ 3,524 $ 3,336 Adjustments related to prior year tax positions — (318) Increases related to current year tax positions 102 506 Balance at end of year $ 3,626 $ 3,524 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of Condensed Consolidated Statements of Operations and Cash Flows | The following table presents the various elements of “income (loss) from discontinued operations, net of income taxes” as reported in the accompanying Consolidated Statements of Operations: Year ended December 31, 2022 2021 Revenues: Product sales, net (1) $ 2,739 $ — Total revenues $ 2,739 $ — Operating costs and expenses: Cost of sales (excluding amortization of intangible assets) 5 133 Selling, general and administrative — — Research and development 31 59 Total operating costs and expenses $ 36 $ 192 Income (loss) from discontinued operations before income taxes 2,703 (192) Provision for income taxes from discontinued operations — — Income (loss) from discontinued operations, net of income taxes $ 2,703 $ (192) (1) Product sales, net for the year ended December 31, 2022 resulted from a reversal of GTN accruals that contractually expired and for which we are no longer liable. |
Description of Business, Basi_2
Description of Business, Basis of Presentation, and Operating Segment (Details) | 12 Months Ended | ||
Sep. 21, 2022 USD ($) tranche | Dec. 31, 2022 USD ($) segment product | Dec. 31, 2021 USD ($) | |
Subsidiary, Sale of Stock [Line Items] | |||
Number of commercial asset products | product | 1 | ||
Number of late stage development drugs | product | 1 | ||
Cash, cash equivalents, and short-term investments | $ 75,096,000 | $ 100,647,000 | |
Amount drawn | $ 30,000,000 | ||
Number of reportable segment | segment | 1 | ||
Number of operating segment | segment | 1 | ||
April 2019 ATM Agreement | |||
Subsidiary, Sale of Stock [Line Items] | |||
Remaining amount to be sold in the offering | $ 128,800,000 | ||
Secured Debt | Term Loan Facility | |||
Subsidiary, Sale of Stock [Line Items] | |||
Debt instrument, term | 5 years | ||
Aggregate principal amount | $ 65,000,000 | 25,000,000 | |
Number of tranches | tranche | 4 | ||
Amount drawn | $ 30,000,000 | ||
Secured Debt | Term B Loan | |||
Subsidiary, Sale of Stock [Line Items] | |||
Debt instrument undrawn amount | $ 10,000,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Use of Estimates - (Details) $ in Thousands, shares in Millions | 12 Months Ended | |
Dec. 31, 2022 USD ($) customer shares | Dec. 31, 2021 USD ($) shares | |
Accounting Policies [Abstract] | ||
Allowance for doubtful accounts receivable | $ 1,300 | |
Anti-dilutive excluded from computation of earnings per share amount (shares) | shares | 22.3 | 13.5 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Allowance for doubtful accounts receivable | $ 1,300 | |
Research and development | 42,203 | $ 87,297 |
Cost of sales | 1,792 | $ 0 |
ROLVEDON | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Research and development | 5,700 | |
ROLVEDON | Pro Forma | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Cost of sales | $ 3,000 | |
Receivable Benchmark | Customer Concentration Risk | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Concentration risk, number of customers | customer | 3 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Asset and Liability Fair Values (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Assets: | ||
Equity securities | $ 136 | $ 5,718 |
Key employee life insurance, cash surrender value | 4,507 | |
Total Assets | 71,034 | 82,946 |
Liabilities: | ||
Deferred executive compensation liability | 4,531 | 11,243 |
Total Liabilities | 4,531 | 11,243 |
Money market funds | ||
Assets: | ||
Available-for-sale | 36,298 | 66,322 |
Government-related debt securities | ||
Assets: | ||
Available-for-sale | 30,348 | |
Mutual funds | ||
Assets: | ||
Available-for-sale | 4,252 | 6,399 |
Level 1 | ||
Assets: | ||
Equity securities | 136 | 5,718 |
Key employee life insurance, cash surrender value | 0 | |
Total Assets | 71,026 | 78,430 |
Liabilities: | ||
Deferred executive compensation liability | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 1 | Money market funds | ||
Assets: | ||
Available-for-sale | 36,298 | 66,322 |
Level 1 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 30,348 | |
Level 1 | Mutual funds | ||
Assets: | ||
Available-for-sale | 4,244 | 6,390 |
Level 2 | ||
Assets: | ||
Equity securities | 0 | 0 |
Key employee life insurance, cash surrender value | 4,507 | |
Total Assets | 8 | 4,516 |
Liabilities: | ||
Deferred executive compensation liability | 4,531 | 11,243 |
Total Liabilities | 4,531 | 11,243 |
Level 2 | Accounts Payable and Accrued Liabilities | ||
Liabilities: | ||
Deferred executive compensation liability | 1,500 | 2,000 |
Level 2 | Other long-term liabilities | ||
Liabilities: | ||
Deferred executive compensation liability | 3,000 | 9,200 |
Level 2 | Money market funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 2 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 0 | |
Level 2 | Mutual funds | ||
Assets: | ||
Available-for-sale | 8 | 9 |
Level 3 | ||
Assets: | ||
Equity securities | 0 | 0 |
Key employee life insurance, cash surrender value | 0 | |
Total Assets | 0 | 0 |
Liabilities: | ||
Deferred executive compensation liability | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 3 | Money market funds | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 | Government-related debt securities | ||
Assets: | ||
Available-for-sale | 0 | |
Level 3 | Mutual funds | ||
Assets: | ||
Available-for-sale | $ 0 | $ 0 |
Balance Sheet Account Detail -
Balance Sheet Account Detail - Summary of Cash and Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | $ 0 | $ 3,512 |
Historical or Amortized Cost | 74,122 | 97,269 |
Equity securities | 136 | 5,718 |
Cash, cash equivalents, and short-term investments | 75,096 | 100,647 |
Level 1 | ||
Schedule of Investments [Line Items] | ||
Equity securities | $ 136 | 5,718 |
Unicycive Therapeutics, Inc. | ||
Schedule of Investments [Line Items] | ||
Number of shares held in investment (in shares) | 300,000 | |
Number of shares sold (in shares) | 600,000 | |
Realized gain on equity securities | $ 500 | |
Unicycive Therapeutics, Inc. | Level 1 | ||
Schedule of Investments [Line Items] | ||
Equity securities | $ 100 | |
CASI Common Stock | ||
Schedule of Investments [Line Items] | ||
Number of shares held in investment (in shares) | 0 | |
Number of shares sold (in shares) | 900,000 | |
Realized loss on equity securities | $ 1,900 | |
Cash and Cash Equivalents | ||
Schedule of Investments [Line Items] | ||
Equity securities | 0 | 0 |
Cash, cash equivalents, and short-term investments | 40,368 | 88,539 |
Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Equity securities | 136 | 5,718 |
Cash, cash equivalents, and short-term investments | 34,728 | 12,108 |
Money market funds | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 36,298 | 66,322 |
Available-for-sale | 36,298 | 66,322 |
Money market funds | Cash and Cash Equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 36,298 | 66,322 |
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 | 30,359 | |
Available-for-sale | 30,348 | |
Government-related debt securities | Cash and Cash Equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 0 | |
Government-related debt securities | Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 30,348 | |
Mutual funds | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 3,395 | 5,218 |
Available-for-sale | 4,244 | 6,390 |
Mutual funds | Cash and Cash Equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 0 | 0 |
Mutual funds | Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 4,244 | 6,390 |
Bank deposits | ||
Schedule of Investments [Line Items] | ||
Historical or Amortized Cost | 4,070 | 22,217 |
Available-for-sale | 4,070 | 22,217 |
Bank deposits | Cash and Cash Equivalents | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | 4,070 | 22,217 |
Bank deposits | Marketable Securities | ||
Schedule of Investments [Line Items] | ||
Available-for-sale | $ 0 | $ 0 |
Balance Sheet Account Detail _2
Balance Sheet Account Detail - Schedule of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Raw materials | $ 4,500 | $ 0 |
Work-in-process | 4,007 | 0 |
Finished goods | 723 | 0 |
Inventories | $ 9,230 | $ 0 |
Balance Sheet Account Detail _3
Balance Sheet Account Detail - Schedule of Accounts Payable and Other Accrued Obligations (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other | $ 30,547 | $ 33,408 |
Lease liability - current portion | 761 | 1,282 |
Product revenue allowances - ROLVEDON | 3,082 | 0 |
Commercial Product Portfolio accruals (Note 10) | 3,715 | 6,568 |
Accounts payable and other accrued liabilities | $ 38,105 | $ 41,258 |
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 _4
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Obligations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accounts Payable And Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | $ 6,568 | $ 7,842 |
(Less): Payment and credits against GTN accruals | (115) | (1,274) |
(Less): Release of GTN accruals | (2,738) | |
Ending balance | 3,715 | 6,568 |
Commercial/Medicaid Rebates and Government Chargebacks | ||
Accounts Payable And Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | 1,442 | 2,601 |
(Less): Payment and credits against GTN accruals | (5) | (1,159) |
(Less): Release of GTN accruals | (117) | |
Ending balance | 1,320 | 1,442 |
Distribution, Data, Inventory, and GPO Administrative Fees | ||
Accounts Payable And Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | 942 | 942 |
(Less): Payment and credits against GTN accruals | 93 | 0 |
(Less): Release of GTN accruals | (871) | |
Ending balance | 164 | 942 |
Product Return Allowances | ||
Accounts Payable And Other Accrued Liabilities [Roll Forward] | ||
Beginning balance | 4,184 | 4,299 |
(Less): Payment and credits against GTN accruals | (203) | (115) |
(Less): Release of GTN accruals | (1,750) | |
Ending balance | $ 2,231 | $ 4,184 |
Loan Payable - Additional Infor
Loan Payable - Additional Information (Details) - Secured Debt | 11 Months Ended | 12 Months Ended | 36 Months Ended | ||||||||
Sep. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 21, 2022 USD ($) tranche day $ / shares shares | Jul. 31, 2023 USD ($) | Sep. 21, 2024 | Sep. 21, 2023 | Dec. 31, 2022 USD ($) | Sep. 21, 2027 | Nov. 15, 2023 USD ($) | May 15, 2023 USD ($) | |
Term Loan Facility | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt instrument, term | 5 years | ||||||||||
Debt instrument, face amount | $ 65,000,000 | $ 25,000,000 | |||||||||
Number of tranches | tranche | 4 | ||||||||||
Borrowings | $ 30,000,000 | ||||||||||
Net product revenue calculation, trailing period | 6 months | ||||||||||
Floor interest rate | 2.30% | ||||||||||
Percentage of upfront fee | 1% | ||||||||||
Exit fee percentage | 4.75% | ||||||||||
Warrants granted (in shares) | shares | 454,545 | ||||||||||
Exercise price of warrants or rights (in dollars per share) | $ / shares | $ 0.66 | ||||||||||
Fair market value of warrants | $ 200,000 | ||||||||||
Warrants that will be issued as percentage of loan amount | 1% | ||||||||||
Number of trading days | day | 10 | ||||||||||
Warrant expiration period | 10 years | ||||||||||
Debt default, interest rate | 4% | ||||||||||
Gross proceeds | 3,000,000 | ||||||||||
Exit fee | 1,400,000 | ||||||||||
Interest expense, debt | 900,000 | ||||||||||
Noncash interest expense | 200,000 | ||||||||||
Term Loan Facility | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Basis spread on variable rate (as a percent) | 5.70% | ||||||||||
Term Loan Facility | Forecast | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Percentage of principal prepayment on term loan | 2% | 1% | |||||||||
Term Loan Facility | Subsequent Event | Forecast | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Percentage of principal prepayment on term loan | 300% | ||||||||||
Term Loan Facility | Subsequent Event | Scenario, Forecast 2 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Net product revenue calculation, trailing period | 6 months | ||||||||||
Term Loan Facility | Subsequent Event | Scenario, Forecast 3 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Net product revenue calculation, trailing period | 12 months | ||||||||||
Term Loan Facility | Subsequent Event | Scenario, Forecast 4 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Net product revenue calculation, trailing period | 6 months | ||||||||||
Term Loan Facility | Maximum | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Additional amount that may be borrowed | $ 25,000,000 | ||||||||||
Term Loan Facility | Minimum | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Net revenues | $ 40,000,000 | ||||||||||
Term Loan Facility | Minimum | Subsequent Event | Forecast | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Cash | $ 25,000,000 | ||||||||||
Term Loan Facility | Minimum | Subsequent Event | Scenario, Forecast 1 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from equity raises or business development and or collaboration arrangements | 40,000,000 | ||||||||||
Term Loan Facility | Minimum | Subsequent Event | Scenario, Forecast 2 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Net revenues | 25,800,000 | ||||||||||
Proceeds from equity raises or business development and or collaboration arrangements | $ 30,000,000 | ||||||||||
Term Loan Facility | Minimum | Subsequent Event | Scenario, Forecast 3 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Net revenues | $ 100,000,000 | ||||||||||
Term A Loan | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Borrowings | $ 30,000,000 | ||||||||||
Term B Loan | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt instrument undrawn amount | 10,000,000 | ||||||||||
Term C Loan | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Facility fee | $ 200,000 | ||||||||||
Success fee percentage | 0.75% | ||||||||||
Term C Loan | Subsequent Event | Forecast | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Additional amount that may be borrowed | $ 15,000,000 | ||||||||||
Net product revenue calculation, trailing period | 6 months | 6 months | |||||||||
Term C Loan | Minimum | Subsequent Event | Forecast | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Net revenues | $ 15,700,000 | ||||||||||
Term D Loan | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Facility fee | $ 100,000 | ||||||||||
Success fee percentage | 0.75% | ||||||||||
Term D Loan | Subsequent Event | Forecast | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Additional amount that may be borrowed | $ 10,000,000 | ||||||||||
Term D Loan | Minimum | Subsequent Event | Forecast | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Net revenues | $ 40,000,000 |
Loan Payable - Summary of Term
Loan Payable - Summary of Term Loan Payable (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Disclosure [Abstract] | |
Gross proceeds | $ 30,000 |
Accrued exit fee | 1,425 |
Unamortized debt discount | (2,759) |
Carrying value | $ 28,666 |
Loan Payable - Maturities Sched
Loan Payable - Maturities Schedule (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Disclosure [Abstract] | |
2023 | $ 0 |
2024 | 0 |
2025 | 3,750 |
2026 | 15,000 |
2027 and thereafter | 11,250 |
Total | $ 30,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) | 1 Months Ended | 12 Months Ended | |||
Jun. 21, 2022 shares | Jan. 31, 2022 | Dec. 31, 2022 USD ($) plan shares | Dec. 31, 2021 USD ($) shares | Oct. 19, 2022 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 | 10% | 11% | |||
Stock-based compensation expense | $ | $ 8,490,000 | $ 19,841,000 | |||
Forfeited (in shares) | 1,230,311 | 34,565 | |||
Vesting percent year one | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 33.333% | ||||
Vesting percent year two | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 33.333% | ||||
Vesting percent year three | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 33.333% | ||||
Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ | $ 2,600,000 | $ 4,500,000 | |||
Unrecognized compensation expense | $ | $ 3,600,000 | ||||
Weighted average period to recognize compensation expense | 1 year 10 months 24 days | ||||
Stock Options | Vesting percent year one | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 33.333% | ||||
Stock Options | Vesting percent year two | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 33.333% | ||||
Stock Options | Vesting percent year three | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 33.333% | ||||
Restricted Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of additional shares available (in percent) | 1.5 | ||||
Unrecognized compensation expense | $ | $ 3,400,000 | ||||
Weighted average period to recognize compensation expense | 1 year 7 months 6 days | ||||
Restricted stock or unit expense | $ | $ 4,600,000 | $ 9,600,000 | |||
Granted (in shares) | 2,160,240 | 2,820,259 | |||
Restricted Stock Units | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of additional shares available (in percent) | 1.5 | ||||
Unrecognized compensation expense | $ | $ 1,200,000 | ||||
Weighted average period to recognize compensation expense | 2 years 4 months 24 days | ||||
Restricted stock or unit expense | $ | $ 300,000 | $ 1,100,000 | |||
Granted (in shares) | 2,665,602 | 2,125 | |||
Restricted Stock Units | Vesting percent year one | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 33.333% | ||||
Restricted Stock Units | Vesting percent year two | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 33.333% | ||||
Restricted Stock Units | Vesting percent year three | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 33.333% | ||||
SARs | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percent | 25% | ||||
Stock-based compensation expense | $ | $ 600,000 | $ 4,200,000 | |||
Unrecognized compensation expense | $ | $ 300,000 | ||||
Weighted average period to recognize compensation expense | 1 year 1 month 6 days | ||||
Granted (in shares) | 0 | 2,100,000 | |||
Forfeited (in shares) | 700,000 | ||||
2018 Long Term Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Additional shares approved (in shares) | 18,000,000 | ||||
2018 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Expiration period | 10 years | ||||
Number of shares authorized for issuance (in shares) | 39,000,000 | ||||
Number of shares available for issuance (in shares) | 14,800,000 | ||||
Exercise price fair value (in percent) | 100% | ||||
2018 Plan | Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price fair value (in percent) | 110% | ||||
2018 Plan | Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of additional shares available (in percent) | 0.01 | ||||
2018 Plan | Restricted Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares available for issuance (in shares) | 9,900,000 | ||||
2009 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of additional shares available (in percent) | 0.01 | ||||
ESPP | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares authorized for issuance (in shares) | 7,500,000 | ||||
Number of shares available for issuance (in shares) | 10,000,000 | ||||
Percentage of common stock purchase price | 15% | ||||
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 | ||||
2022 Employment Inducement Incentive Award Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares authorized for issuance (in shares) | 5,000,000 | ||||
Number of shares available for issuance (in shares) | 4,100,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 8,490 | $ 19,841 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | 6,058 | 14,644 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 2,432 | $ 5,197 |
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, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected option life (in years) | 4 years 5 months 1 day | 5 years 6 months 25 days |
Risk-free interest rate, Minimum | 1.70% | 0.56% |
Risk-free interest rate, Maximum | 4.42% | 1.32% |
Volatility, Minimum (as percent) | 83.60% | 80% |
Volatility, Maximum (as percent) | 90.50% | 82.70% |
Dividend yield (as percent) | 0% | 0% |
Weighted-average grant-date fair value per stock option (in dollars per share) | $ 0.40 | $ 1.78 |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected option life (in years) | 10 years | 10 years |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Shares | ||
Outstanding, beginning (in shares) | 9,505,461 | 7,656,623 |
Granted (in shares) | 6,885,316 | 2,397,684 |
Exercised (in shares) | 0 | (1,250) |
Forfeited (in shares) | (1,230,311) | (34,565) |
Expired (in shares) | (1,683,843) | (513,031) |
Outstanding, ending (in shares) | 13,476,623 | 9,505,461 |
Expected to Vest (in shares) | 6,090,775 | |
Vested and Exercisable (in shares) | 6,594,608 | |
Weighted- Average Exercise Price/Share | ||
Outstanding, beginning (in dollars per share) | $ 6.42 | $ 7.80 |
Granted (in dollars per share) | 0.68 | 2.66 |
Exercised (in dollars per share) | 0 | 3.04 |
Forfeited (in dollars per share) | 1.22 | 10.05 |
Expired (in dollars per share) | 7.65 | 9.29 |
Outstanding, ending (in dollars per share) | 3.81 | $ 6.42 |
Expected to Vest (in dollars per share) | 1.10 | |
Vested and Exercisable (in dollars per share) | $ 6.64 | |
Weighted-Average Remaining Contractual Term (in years), Outstanding | 6 years 9 months 18 days | |
Weighted-Average Remaining Contractual Term (in years), Expected to Vest | 9 years 10 days | |
Weighted-Average Remaining Contractual Term (in years), Vested and Exercisable | 4 years 5 months 12 days | |
Aggregate Intrinsic Value, Exercised | $ 0 | $ 1,500 |
Aggregate Intrinsic Value, Outstanding | 0 | |
Aggregate Intrinsic Value, Expected to Vest | 0 | |
Aggregate Intrinsic Value, Vested and Exercisable | $ 0 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Grants (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Granted Stock Options Outstanding (in shares) | shares | 13,476,623 |
Weighted- Average Remaining Contractual Life (in years) | 6 years 9 months 18 days |
Weighted-Average Exercise Price (in dollars per share) | $ 3.81 |
Granted Stock Options Exercisable (in shares) | shares | 6,594,608 |
Weighted-Average Exercise Price (in dollars per share) | $ 6.64 |
$0.63 - 4.96 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 0.63 |
Exercise price, range upper limit (in dollars per share) | $ 4.96 |
Granted Stock Options Outstanding (in shares) | shares | 9,809,291 |
Weighted- Average Remaining Contractual Life (in years) | 7 years 11 months 26 days |
Weighted-Average Exercise Price (in dollars per share) | $ 1.41 |
Granted Stock Options Exercisable (in shares) | shares | 2,955,694 |
Weighted-Average Exercise Price (in dollars per share) | $ 2.23 |
$4.97 - 6.91 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 4.97 |
Exercise price, range upper limit (in dollars per share) | $ 6.91 |
Granted Stock Options Outstanding (in shares) | shares | 1,317,760 |
Weighted- Average Remaining Contractual Life (in years) | 3 years 2 months 23 days |
Weighted-Average Exercise Price (in dollars per share) | $ 5.97 |
Granted Stock Options Exercisable (in shares) | shares | 1,317,760 |
Weighted-Average Exercise Price (in dollars per share) | $ 5.97 |
$6.92 - 9.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 6.92 |
Exercise price, range upper limit (in dollars per share) | $ 9 |
Granted Stock Options Outstanding (in shares) | shares | 855,991 |
Weighted- Average Remaining Contractual Life (in years) | 2 years 2 months 8 days |
Weighted-Average Exercise Price (in dollars per share) | $ 7.74 |
Granted Stock Options Exercisable (in shares) | shares | 855,991 |
Weighted-Average Exercise Price (in dollars per share) | $ 7.74 |
$9.01 - 12.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 9.01 |
Exercise price, range upper limit (in dollars per share) | $ 12 |
Granted Stock Options Outstanding (in shares) | shares | 650,723 |
Weighted- Average Remaining Contractual Life (in years) | 5 years 1 month 20 days |
Weighted-Average Exercise Price (in dollars per share) | $ 11.17 |
Granted Stock Options Exercisable (in shares) | shares | 622,305 |
Weighted-Average Exercise Price (in dollars per share) | $ 11.19 |
$12.01 - 22.64 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, range lower limit (in dollars per share) | 12.01 |
Exercise price, range upper limit (in dollars per share) | $ 22.64 |
Granted Stock Options Outstanding (in shares) | shares | 842,858 |
Weighted- Average Remaining Contractual Life (in years) | 4 years 5 months 8 days |
Weighted-Average Exercise Price (in dollars per share) | $ 18.66 |
Granted Stock Options Exercisable (in shares) | shares | 842,858 |
Weighted-Average Exercise Price (in dollars per share) | $ 18.66 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Restricted Stock and Restricted Stock Unit Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restricted Stock | ||
Number of Restricted Stock Awards | ||
Unvested, Beginning Balance (in shares) | 4,436,007 | 4,496,045 |
Granted (in shares) | 2,160,240 | 2,820,259 |
Vested/Share issuance (in shares) | (2,025,140) | (2,272,064) |
Forfeited (in shares) | (1,756,002) | (608,233) |
Unvested, Ending Balance (in shares) | 2,815,105 | 4,436,007 |
Weighted Average Fair Value per Share at Grant Date | ||
Beginning Balance (in dollars per share) | $ 3.33 | $ 4.29 |
Granted (in dollars per share) | 1.20 | 3.33 |
Vested/Share issuance (in dollars per share) | 3.40 | 5.06 |
Forfeited (in dollars per share) | 2.23 | 3.85 |
Ending Balance (in dollars per share) | $ 2.11 | $ 3.33 |
Restricted Stock Units | ||
Number of Restricted Stock Awards | ||
Unvested, Beginning Balance (in shares) | 184,512 | 263,524 |
Granted (in shares) | 2,665,602 | 2,125 |
Market-based achievement adjustment at vesting (in shares) | 75,000 | |
Vested/Share issuance (in shares) | (135,013) | (151,386) |
Forfeited (in shares) | (274,539) | (4,751) |
Unvested, Ending Balance (in shares) | 2,440,562 | 184,512 |
Weighted Average Fair Value per Share at Grant Date | ||
Beginning Balance (in dollars per share) | $ 23.53 | $ 26.39 |
Granted (in dollars per share) | 0.59 | 3.61 |
Market-based achievement adjustment at vesting (in dollars per share) | 0 | |
Vested/Share issuance (in dollars per share) | 0.37 | 28.09 |
Forfeited (in dollars per share) | 0.63 | 4.03 |
Ending Balance (in dollars per share) | $ 0.63 | $ 23.53 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Jul. 21, 2021 | Nov. 06, 2020 | May 08, 2020 | Apr. 05, 2019 | Jan. 31, 2022 | Dec. 31, 2022 | |
Year One | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percent | 33.333% | |||||
Year Two | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percent | 33.333% | |||||
Year Three | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percent | 33.333% | |||||
April 2019 ATM Agreement | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Maximum proceeds to be raised | $ 60,000,000 | $ 75,000,000 | $ 150,000,000 | |||
Remaining amount to be sold in the offering | $ 128,800,000 | |||||
Registration Statement, July 2021 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Maximum proceeds to be raised | $ 300,000,000 | |||||
Registration Statement, July 2021 | Common Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Maximum proceeds to be raised | $ 150,000,000 | |||||
Securities Purchase Agreement | Hanmi | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares sold in public offering (in shares) | 12,500,000 | |||||
Shares sold in public offering (in dollars per share) | $ 1.60 | |||||
Equity financing received | $ 20,000,000 | |||||
Stock Options | Year One | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percent | 33.333% | |||||
Stock Options | Year Two | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percent | 33.333% | |||||
Stock Options | Year Three | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percent | 33.333% | |||||
Restricted stock units | Year One | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percent | 33.333% | |||||
Restricted stock units | Year Two | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percent | 33.333% | |||||
Restricted stock units | Year Three | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percent | 33.333% |
Stockholders' Equity - Sales Ag
Stockholders' Equity - Sales Agreement (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Equity [Abstract] | ||
No. of Common Shares Issued (in shares) | 24,513,945 | 15,851,391 |
Proceeds Received (Net of Broker Commissions and Fees ) | $ 26,561 | $ 52,621 |
Financial Commitments & Conti_3
Financial Commitments & Contingencies and Key License Agreements - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jan. 01, 2022 | Dec. 31, 2020 | Apr. 30, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | |
Long-term Purchase Commitment [Line Items] | |||||
Right-of-use assets in exchange for lease liabilities | $ 400,000 | $ 1,800,000 | |||
Facility and equipment under lease | 1,694,000 | 2,505,000 | |||
Accounts payable and other accrued liabilities | 38,105,000 | 41,258,000 | |||
Accrued payroll and benefits | 4,580,000 | 11,971,000 | |||
Deferred compensation liability, current and noncurrent | 4,500,000 | 11,200,000 | |||
Tom Riga | |||||
Long-term Purchase Commitment [Line Items] | |||||
Accrued payroll and benefits | 3,100,000 | ||||
Hanmi | ROLVEDON, Co-Development and Commercialization Agreement | |||||
Long-term Purchase Commitment [Line Items] | |||||
Reduction in accrued liabilities | $ 11,200,000 | ||||
Royalty expense | 400,000 | ||||
Inventory purchases | 9,000,000 | ||||
Accounts payable and other accrued liabilities | 9,800,000 | ||||
Hanmi | Eflapegrastim: Co-Development and Commercialization Agreement with Hanmi | |||||
Long-term Purchase Commitment [Line Items] | |||||
Potential payments based on additional achievements of regulatory milestones | $ 10,000,000 | ||||
Hanmi | Poziotinib: In-License Agreement with Hanmi and Exclusive Patent and Technology License Agreement with MD Anderson | |||||
Long-term Purchase Commitment [Line Items] | |||||
Achievement of regulatory milestones potential payments | 18,000,000 | ||||
Supplemental royalty milestone limit | $ 15,000,000 | ||||
MD Anderson | |||||
Long-term Purchase Commitment [Line Items] | |||||
Achievement of regulatory milestones potential payments | 6,000,000 | ||||
Payment of upfront fee | 500,000 | ||||
Potential payments based on achievement of sales milestones | $ 24,000,000 | ||||
Therapyx | In-License Agreement with Therapyx | |||||
Long-term Purchase Commitment [Line Items] | |||||
Asset purchase agreement, upfront payment | $ 800,000 | ||||
Potential payments based on worldwide annual net sales | 167,500,000 | ||||
Therapyx | In-License Agreement with Therapyx | Acceptance of certain transferred materials | |||||
Long-term Purchase Commitment [Line Items] | |||||
Potential payments based on additional achievements of regulatory milestones | 2,200,000 | ||||
Therapyx | In-License Agreement with Therapyx | First approved IL-12 product | |||||
Long-term Purchase Commitment [Line Items] | |||||
Potential payments based on additional achievements of regulatory milestones | 30,000,000 | ||||
Therapyx | In-License Agreement with Therapyx | Each new indication approved for each product in the U.S., Europe, or Japan | |||||
Long-term Purchase Commitment [Line Items] | |||||
Potential payments based on additional achievements of regulatory milestones | $ 2,500,000 | ||||
Office and research facilities | |||||
Long-term Purchase Commitment [Line Items] | |||||
Facility and equipment under lease | 1,400,000 | 2,100,000 | |||
Office equipment | |||||
Long-term Purchase Commitment [Line Items] | |||||
Facility and equipment under lease | $ 300,000 | $ 400,000 | |||
Minimum | |||||
Long-term Purchase Commitment [Line Items] | |||||
Remaining term | 2 years | ||||
Maximum | |||||
Long-term Purchase Commitment [Line Items] | |||||
Remaining term | 4 years |
Financial Commitments & Conti_4
Financial Commitments & Contingencies and Key License Agreements - Operating Lease Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use assets - non-current | $ 1,694 | $ 2,505 |
Operating lease liabilities - current | 761 | 1,282 |
Operating lease liabilities - non-current | 1,056 | 1,452 |
Total operating lease liabilities | $ 1,817 | $ 2,734 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accounts payable and other accrued liabilities | Accounts payable and other accrued liabilities |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other long-term liabilities | Other long-term liabilities |
Financial Commitments & Conti_5
Financial Commitments & Contingencies and Key License Agreements - Components of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 1,298 | $ 1,711 |
Variable lease cost | 242 | 378 |
Short-term lease cost | 47 | 63 |
Total lease cost | $ 1,587 | $ 2,152 |
Financial Commitments & Conti_6
Financial Commitments & Contingencies and Key License Agreements - Summary of Operating Lease Term and Discount Rate (Details) | Dec. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted Average Remaining Lease Term | 2 years 6 months | 2 years 8 months 12 days |
Weighted Average Discount Rate | 3% | 3.80% |
Financial Commitments & Conti_7
Financial Commitments & Contingencies and Key License Agreements - Operating Lease Minimum Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
2023 | $ 804 | |
2024 | 821 | |
2025 | 188 | |
2026 | 73 | |
2027 | 0 | |
Total future lease payments, undiscounted | 1,886 | |
(Less): Implied interest | (69) | |
Present value of operating lease payments | $ 1,817 | $ 2,734 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Benefit for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (78,126) | $ (158,552) |
Foreign | 68 | 120 |
Loss from continuing operations before income taxes | $ (78,058) | $ (158,432) |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | ||
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Foreign | 46 | 4 |
Current, total | 46 | 4 |
Deferred: | ||
Federal | 0 | 0 |
State | 0 | 0 |
Foreign | 0 | 0 |
Deferred, total | 0 | 0 |
Total income tax expense | $ 46 | $ 4 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | ||
Foreign tax expense | $ 46 | $ 4 |
Valuation allowance | 256,063 | 242,590 |
Increase in valuation allowance due to deferred tax assets | 13,500 | 50,100 |
Increase from losses in continuing operations | (13,700) | |
Decrease in income from discontinued operations | 200 | |
Federal net operating loss carryforwards | 789,300 | |
State net operating loss carryforwards | 603,400 | |
Foreign loss carryforwards | 500 | |
Research and development tax credits | 27,669 | 27,341 |
Unrecognized tax benefits, if recognized, would affect the effective tax rate | 100 | $ 100 |
Federal | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards not subject to expiration | 510,700 | |
Research and development tax credits | 19,000 | |
State | ||
Income Taxes [Line Items] | ||
Research and development tax credits | $ 11,000 |
Income Taxes - Income Tax Expen
Income Taxes - Income Tax Expense Differs from Computed Using Federal Statutory Rate Applied to Income Before Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Tax provision computed at the federal statutory rate | $ (16,392) | $ (33,210) |
State tax, net of federal benefit | (2,913) | (11,050) |
Research and development expense tax credits | (328) | (1,838) |
Officers compensation | (738) | 1,988 |
Stock based compensation | 2,688 | 1,234 |
Permanent items and other | 157 | (173) |
Change in tax rate | 3,288 | (6,671) |
Change in prior year deferred taxes | 568 | (353) |
Valuation allowance | 13,716 | 50,077 |
Total income tax expense | $ 46 | $ 4 |
Income Taxes - Components of Co
Income Taxes - Components of Company's Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 198,162 | $ 187,129 |
Research and development expense tax credits | 27,669 | 27,341 |
Stock based compensation | 4,136 | 5,470 |
Lease obligation | 456 | 783 |
ROLVEDON supplies | 9,337 | 0 |
Returns and allowances | 636 | 1,198 |
Amortization differences | 857 | 1,749 |
Capitalized research and development expenses | 12,218 | 0 |
Other, net | 3,114 | 20,610 |
Total deferred tax assets before valuation allowance | 256,585 | 244,280 |
Valuation allowance | (256,063) | (242,590) |
Total deferred tax assets | 522 | 1,690 |
Deferred tax liabilities, net: | ||
Unrealized gains | (97) | (973) |
Right-of-use asset | (425) | (717) |
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, 2022 | Dec. 31, 2021 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 3,524 | $ 3,336 |
Adjustments related to prior year tax positions | 0 | (318) |
Increases related to current year tax positions | 102 | 506 |
Balance at end of year | $ 3,626 | $ 3,524 |
Discontinued Operations - Addit
Discontinued Operations - Additional Information (Details) - Commercial Product Portfolio - Sale $ in Millions | 1 Months Ended |
Mar. 31, 2019 USD ($) product | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |
Number of products | product | 7 |
Upfront payment expected to be received | $ 158.8 |
Aggregate amount receivable based on achievement of milestones | 140 |
Payments receivable based on achievement of regulatory milestones | 40 |
Potential payments based on achievement of sales milestones | $ 100 |
Discontinued Operations - Conso
Discontinued Operations - Consolidated Statement of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating costs and expenses: | ||
Income (loss) from discontinued operations, net of income taxes | $ 2,703 | $ (192) |
Commercial Product Portfolio | Sale | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Total revenues | 2,739 | 0 |
Operating costs and expenses: | ||
Selling, general and administrative | 0 | 0 |
Research and development | 31 | 59 |
Total operating costs and expenses | 36 | 192 |
Income (loss) from discontinued operations before income taxes | 2,703 | (192) |
Provision for income taxes from discontinued operations | 0 | 0 |
Income (loss) from discontinued operations, net of income taxes | 2,703 | (192) |
Commercial Product Portfolio | Sale | Product sales, net | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Total revenues | 2,739 | 0 |
Operating costs and expenses: | ||
Cost of sales (excluding amortization of intangible assets) | $ 5 | $ 133 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Jan. 31, 2023 | Mar. 22, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | ||||
Issuance of common shares (in shares) | 24,513,945 | 15,851,391 | ||
Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Amount received under the coronavirus aid, relief, and economic security act. | $ 1.2 | |||
Subsequent Event | April 2019 ATM Agreement | ||||
Subsequent Event [Line Items] | ||||
Issuance of common shares (in shares) | 2,000,000 | |||
Net proceeds from issuance of common stock | $ 1.8 |