Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 25, 2022 | Jun. 30, 2021 | |
Document Information [Line Items] | |||
Entity Central Index Key | 0001401667 | ||
Entity Registrant Name | PUMA BIOTECHNOLOGY, INC. | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2021 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Transition Report | false | ||
Entity File Number | 001-35703 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 77-0683487 | ||
Entity Address, Address Line One | 10880 Wilshire Boulevard, Suite 2150 | ||
Entity Address, City or Town | Los Angeles | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 90024 | ||
City Area Code | 424 | ||
Local Phone Number | 248-6500 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | PBYI | ||
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 | Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 373,900,000 | ||
Entity Common Stock, Shares Outstanding | 41,332,920 | ||
Auditor Name | KPMG LLP | ||
Auditor Location | Los Angeles, CA | ||
Auditor Firm ID | 185 | ||
ICFR Auditor Attestation Flag | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 63,131 | $ 85,293 |
Marketable securities | 18,975 | 8,096 |
Accounts receivable, net of allowance for credit loss of $0 and $1,000 | 32,526 | 25,543 |
Inventory, net | 7,109 | 3,454 |
Prepaid expenses, current | 8,984 | 11,262 |
Restricted cash, current | 8,850 | 8,850 |
Other current assets | 447 | 3,641 |
Total current assets | 140,022 | 146,139 |
Lease right-of-use assets, net | 14,017 | 16,404 |
Property and equipment, net | 1,756 | 2,481 |
Intangible assets, net | 66,125 | 74,140 |
Restricted cash, long-term | 3,311 | 3,311 |
Prepaid expenses and other, long-term | 1,354 | 1,745 |
Total assets | 226,585 | 244,220 |
Current liabilities: | ||
Accounts payable | 11,174 | 12,076 |
Accrued expenses, current | 92,575 | 61,325 |
Accrued in-licensed rights, current | 0 | 20,993 |
Post-marketing commitment liability, current | 2,263 | 2,481 |
Lease liabilities, current | 3,574 | 3,094 |
Current portion of long-term debt | 0 | 14,286 |
Total current liabilities | 109,586 | 114,255 |
Accrued expenses, long-term | 915 | 25,963 |
Lease liabilities, long-term | 15,975 | 19,549 |
Post-marketing commitment liability, long-term | 5,463 | 6,379 |
Total long-term debt, net | 97,092 | 84,025 |
Total liabilities | 229,031 | 250,171 |
Commitments and contingencies (Note 14) | ||
Stockholders' deficit: | ||
Common stock - $.0001 par value per share; 100,000,000 shares authorized; 41,175,507 shares issued and outstanding at December 31, 2021 and 40,086,387 issued and outstanding at December 31, 2020 | 4 | 4 |
Additional paid-in capital | 1,364,309 | 1,331,676 |
Accumulated other comprehensive income | (2) | 0 |
Accumulated deficit | (1,366,757) | (1,337,631) |
Total stockholders' deficit | (2,446) | (5,951) |
Total liabilities and stockholders' deficit | $ 226,585 | $ 244,220 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Allowance for credit loss | $ 0 | $ 1,000 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 41,175,507 | 41,175,507 |
Common stock, shares outstanding (in shares) | 40,086,387 | 40,086,387 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | |||
Total revenue | $ 253,155 | $ 225,110 | $ 272,260 |
Operating costs and expenses: | |||
Cost of sales | 63,701 | 39,374 | 36,815 |
Selling, general and administrative | 116,294 | 118,488 | 141,639 |
Research and development | 71,870 | 97,650 | 132,851 |
Total operating costs and expenses | 251,865 | 255,512 | 311,305 |
Income (1oss) from operations | 1,290 | (30,402) | (39,045) |
Other income (expenses): | |||
Interest income | 160 | 489 | 2,847 |
Interest expense | (12,807) | (14,046) | (15,019) |
Legal verdict expense | (9,591) | (16,196) | (16,350) |
Loss on debt extinguishment | (8,146) | 0 | (8,103) |
Other income | 292 | 367 | 128 |
Total other expenses | (30,092) | (29,386) | (36,497) |
Loss before income taxes | (28,802) | (59,788) | (75,542) |
Income tax expense | (324) | (207) | (53) |
Net loss | $ (29,126) | $ (59,995) | $ (75,595) |
Net loss applicable to common stockholders (in dollars per share) | $ (29,126) | $ (59,995) | $ (75,595) |
Net loss per share of common stock—basic and diluted (in dollars per share) | $ (0.72) | $ (1.52) | $ (1.95) |
Weighted-average shares of common stock outstanding—basic and diluted (in shares) | 40,638,852 | 39,576,107 | 38,768,653 |
Product [Member] | |||
Revenue: | |||
Total revenue | $ 189,064 | $ 196,728 | $ 211,619 |
License [Member] | |||
Revenue: | |||
Total revenue | 51,750 | 22,700 | 60,250 |
Royalty [Member] | |||
Revenue: | |||
Total revenue | $ 12,341 | $ 5,682 | $ 391 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Net loss | $ (29,126) | $ (59,995) | $ (75,595) |
Other comprehensive (loss) income: | |||
Unrealized (loss) gain on available-for-sale securities, net of tax of $0, $0, and $0 | (2) | (65) | 72 |
Reclassifications of gain on available-for-sale securities, included in “Other income (expenses)," net of tax of $0, $0, and $0 | 0 | 3 | 2 |
Comprehensive loss | $ (29,128) | $ (60,057) | $ (75,521) |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive Loss (Parentheticals) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Unrealized loss on available-for-sale securities, tax | $ 0 | $ 0 | $ 0 |
Reclassifications of gain on available-for-sale securities, included in “Other income (expense)”, tax | $ 0 | $ 0 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Deficit - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2018 | 38,325,037 | ||||
Balance at Dec. 31, 2018 | $ 4 | $ 1,236,355 | $ (12) | $ (1,202,041) | $ 34,306 |
Stock-based compensation | $ 0 | 57,327 | 0 | 0 | 57,327 |
Shares issued or restricted stock units vested under employee stock plans (in shares) | 878,267 | ||||
Shares issued or restricted stock units vested under employee stock plans | $ 0 | 1,351 | 0 | 0 | 1,351 |
Reclassifications of gain on available-for-sale securities, included in “Other income (expenses)," net of tax of $0, $0, and $0 | 0 | 0 | 2 | 0 | 2 |
Unrealized (loss) gain on available-for-sale securities, net of tax of $0, $0, and $0 | 0 | 0 | 72 | 0 | 72 |
Net loss | $ 0 | 0 | 0 | (75,595) | (75,595) |
Balance (in shares) at Dec. 31, 2019 | 39,203,304 | ||||
Balance at Dec. 31, 2019 | $ 4 | 1,295,033 | 62 | (1,277,636) | 17,463 |
Stock-based compensation | $ 0 | 36,575 | 0 | 0 | 36,575 |
Shares issued or restricted stock units vested under employee stock plans (in shares) | 883,083 | ||||
Shares issued or restricted stock units vested under employee stock plans | $ 0 | 68 | 0 | 0 | 68 |
Reclassifications of gain on available-for-sale securities, included in “Other income (expenses)," net of tax of $0, $0, and $0 | 0 | 0 | 3 | 0 | 3 |
Unrealized (loss) gain on available-for-sale securities, net of tax of $0, $0, and $0 | 0 | 0 | (65) | 0 | (65) |
Net loss | $ 0 | 0 | 0 | (59,995) | $ (59,995) |
Balance (in shares) at Dec. 31, 2020 | 40,086,387 | 40,086,387 | |||
Balance at Dec. 31, 2020 | $ 4 | 1,331,676 | 0 | (1,337,631) | $ (5,951) |
Stock-based compensation | $ 0 | 32,633 | 0 | 0 | 32,633 |
Shares issued or restricted stock units vested under employee stock plans (in shares) | 1,089,120 | ||||
Shares issued or restricted stock units vested under employee stock plans | $ 0 | 0 | 0 | 0 | 0 |
Reclassifications of gain on available-for-sale securities, included in “Other income (expenses)," net of tax of $0, $0, and $0 | 0 | ||||
Unrealized (loss) gain on available-for-sale securities, net of tax of $0, $0, and $0 | 0 | 0 | (2) | 0 | (2) |
Net loss | $ 0 | 0 | 0 | (29,126) | $ (29,126) |
Balance (in shares) at Dec. 31, 2021 | 41,175,507 | 40,086,387 | |||
Balance at Dec. 31, 2021 | $ 4 | $ 1,364,309 | $ (2) | $ (1,366,757) | $ (2,446) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | |||
Net loss | $ (29,126) | $ (59,995) | $ (75,595) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation and amortization | 10,598 | 10,033 | 8,077 |
Stock-based compensation | 32,633 | 36,575 | 57,327 |
Provision for credit loss recovery | (1,000) | ||
Provision for credit loss expense | 0 | 1,000 | 0 |
Disposal of property and equipment | 1 | 0 | 54 |
Loss on impairment of asset | 0 | 0 | 1,183 |
Loss on debt extinguishment | 8,146 | 0 | 8,047 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (5,983) | 2,353 | (8,123) |
Inventory, net | (3,655) | (284) | (545) |
Prepaid expenses and other | 2,669 | 2,207 | 414 |
Other current assets | 3,194 | (3,120) | 1,464 |
Accounts payable | (902) | (7,107) | (1,526) |
Accrued expenses and other | 5,209 | 19,251 | 22,599 |
Post-marketing commitment liability | (1,134) | (140) | 9,000 |
Net cash provided by operating activities | 20,650 | 773 | 22,376 |
Investing activities: | |||
Purchase of property and equipment | 0 | (46) | (306) |
Purchase of available-for-sale securities | (38,073) | (29,826) | (127,198) |
Sale of available-for-sale securities | 0 | 0 | 28,135 |
Maturity of available-for-sale securities | 27,192 | 73,275 | 104,532 |
Purchase of intangible assets | 0 | (10,000) | 0 |
Net cash provided by (used in) investing activities | (10,881) | 33,403 | 5,163 |
Financing activities: | |||
Net proceeds from shares issued under employee stock plans | 0 | 68 | 1,351 |
Proceeds from debt | 98,500 | 8,444 | 25,000 |
Payment of debt | (100,000) | (8,444) | (80,000) |
Payment of prepayment costs, end of loan payment and other extinguishment costs | (8,521) | 0 | (7,793) |
Payment of debt issuance costs | (1,910) | 0 | (5,625) |
Installment payment for purchase of intangible asset | (20,000) | (10,000) | 0 |
Net cash used in financing activities | (31,931) | (9,932) | (67,067) |
Net increase (decrease) in cash, cash equivalents and restricted cash | (22,162) | 24,244 | (39,528) |
Cash, cash equivalents and restricted cash, beginning of period | 97,454 | 73,210 | 112,738 |
Cash, cash equivalents and restricted cash, end of period | 75,292 | 97,454 | 73,210 |
Supplemental disclosures of non-cash investing and financing activities: | |||
Intangibles in accrued expenses | 0 | 20,000 | 0 |
Property and equipment purchases in accounts payable | 0 | 0 | 25 |
Supplemental disclosure of cash flow information: | |||
Interest paid | 10,342 | 9,703 | 11,739 |
Income taxes paid | $ 324 | $ 207 | $ 53 |
Note 1 - Business and Basis of
Note 1 - Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Business Description and Basis of Presentation [Text Block] | Note 1—Business Puma Biotechnology, Inc. (the "Company") is a biopharmaceutical company based in Los Angeles, California with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses from Pfizer Inc. ("Pfizer") the global development and commercialization rights to PB272 PB272 PB357. HER1, HER2 HER4. HER2 HER2 HER2, The Company has two The accompanying consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles ("US GAAP"). The Company has incurred significant operating losses since its inception. The Company believes that it will continue to incur net losses and may 2017, first PB272 HER2 July 2017, In February 2020, HER2 two HER2 In 2018, HER2 one The Company is required to make substantial payments to Pfizer upon the achievement of certain milestones and has contractual obligations for clinical trial contracts. The Company has entered into other exclusive sub-license agreements with various parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved, in many regions outside the United States, including Europe (excluding Russia and Ukraine), Australia, Canada, China, Southeast Asia, Israel, South Korea, and various countries and territories in Central and South America. The Company plans to continue to pursue commercialization of NERLYNX in other countries outside the United States, if approved. The Company has reported a net loss of approximately $29.1 million and cash flows from operations of approximately $20.7 million for the year ended December 31, 2021 may December 31, 2021 December 31, 2021 one 10 no may 19 may Since its inception through December 31, 2021 |
Note 2 - Significant Accounting
Note 2 - Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 2—Significant The significant accounting policies followed in the preparation of these consolidated financial statements are as follows: Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Reclassifications In preparing the 2021 December 31, 2020. not Segment Reporting Management has determined that the Company operates in one Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of revenues and expenses for the period presented. Accordingly, actual results could differ from those estimates. Significant estimates include estimates for variable consideration for which reserves were established. These estimates are included in the calculation of net revenues and include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products. Other significant estimates also include those related to legal and other expense accruals. Net Loss per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the periods presented, as required by ASC 260 not For the Years Ended December 31, 2021 2020 2019 Options outstanding 4,595,247 5,009,342 5,042,325 Warrant outstanding 2,116,250 2,116,250 2,116,250 Unvested restricted stock units 1,399,317 1,854,205 1,991,125 Totals 8,110,814 8,979,797 9,149,700 Revenue Recognition Under ASC Topic 606, Revenue from Contracts with Customers 606" no July 17, 2017. Product Revenue, Net The Company sells NERLYNX to a limited number of specialty pharmacies and specialty distributors in the United States. These customers subsequently resell the Company’s products to patients and certain medical centers or hospitals. In addition to distribution agreements with these customers, the Company enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the specialty pharmacy or specialty distributor, as applicable, obtains control of the Company's product, which occurs at a point in time (upon delivery). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 10 68 Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods and are recorded in cost of sales. If taxes should be collected from customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one no December 31, 2021 For the period ended December 31, 2021 December 31, 2020 December 31, 2019 Reserves for Variable Consideration Revenue from product sales is recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the related sales, and are classified as reductions of accounts receivable, net when the right of offset exists in accordance with ASU 2013 1, Balance Sheet (Topic 210 606 The amount of variable consideration that is included in the transaction price may not not December 31, 2021 not December 31, 2021 may Trade Discounts and Allowances The Company generally provides customers with discounts, which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. The reserve for discounts is established in the same period that the related revenue is recognized, together with reductions to accounts receivables, net on the consolidated balance sheets. In addition, the Company compensates its customers for sales order management, data, and distribution services. The Company has determined such services received to date are not Product Returns Consistent with industry practice, the Company offers the specialty pharmacies and specialty distributors that are its customers limited product return rights for damaged and expiring product, provided it is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company estimates the amount of its product sales that may Provider Chargebacks and Discounts Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to its customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. The reserve for chargebacks is established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and a reduction to accounts receivable, net on the consolidated balance sheets. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the customer’s notification to the Company of the resale. Chargebacks consist of credits the Company expects to issue for units that remain in the distribution channel at each reporting period end that the Company expects will be sold to qualified healthcare providers and chargebacks that customers have claimed, but for which the Company has not Government Rebates The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheets. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not not Payor Rebates The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue, net and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheets. Other Incentives Other incentives the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses on the consolidated balance sheets. License Revenue The Company also recognizes license revenue under certain of the Company’s sub-license agreements that are within the scope of ASC 606. may may 606 not no not 45 Prior to recognizing revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not If there are multiple distinct performance obligations, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined based on the prices charged to customers or using expected cost-plus margin. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure. Since 2018, License fees under the sub-license agreements include one one December 31, 2021 Royalty Revenue For sub-license agreements that are within the scope of ASC 606, 606 10 55 65. 30 90 Legal Contingencies and Expense For legal contingencies, the Company accrues a liability for an estimated loss if the potential loss from any claim or legal proceeding is considered probable and the amount can be reasonably estimated. Legal fees and expenses are expensed as incurred based on invoices or estimates provided by legal counsel. The Company periodically evaluates available information, both internal and external, relative to such contingencies and adjusts the accrual as necessary. The Company determines whether a contingency should be disclosed by assessing whether a material loss is deemed reasonably possible. In determining whether a loss should be accrued, the Company evaluates, among other factors, the degree of probability of an unfavorable outcome and the ability to make a reasonable estimate of the amount of the loss (see Note 14 Royalty Expenses Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 14 Research and Development Expenses Research and development ("R&D") expenses are charged to operations as incurred. The major components of research and development costs include clinical manufacturing costs, clinical trial expenses, consulting and other third not third may In instances where the Company enters into agreements with third not may may Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development costs. Stock-Based Compensation Stock option awards ASC Topic 718, Compensation-Stock Compensation 718" 718, not 718, six Restricted stock units RSUs are valued on the grant date and the fair value of the RSUs is equal to the market price of the Company’s common stock on the grant date. The RSU expense is recognized over the requisite service period in the statement of operations. When the requisite service period begins prior to the grant date (because the service inception date occurs prior to the grant date), the Company is required to begin recognizing compensation cost before there is a measurement date (i.e., the grant date). The service inception date is the beginning of the requisite service period. If the service inception date precedes the grant date, accrual of compensation cost for periods before the grant date shall be based on the fair value of the award at the reporting date. In the period in which the grant date occurs, cumulative compensation cost shall be adjusted to reflect the cumulative effect of measuring compensation cost based on fair value at the grant date rather than the fair value previously used at the service inception date (or any subsequent reporting date). RSU forfeitures are estimated when the RSU is granted to reduce the RSU expense to be recognized over the life of the award. The estimated forfeiture rate considers historical employee turnover rates stratified into employee pools, actual forfeiture experience and other factors. The RSU expense is “trued-up” upon the actual forfeiture of a RSU grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates. Compensation expense related to modified restricted stock units is measured based on the fair value for the awards as of the modification date. Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite service period, as appropriate. Warrants Warrants (see Note 11 718, nine Income Taxes The Company follows ASC Topic 740, Income Taxes 740" not not The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the consolidated financial statements. Under ASC 740, may not 50% 740 uidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. As of December 31, 2021 , the Company’s uncertain tax position includes a reserve for its R&D credits. Financial Instruments The carrying value of financial instruments, such as cash equivalents, accounts receivable and accounts payable, approximate their fair value because of their short-term nature. The carrying value of long-term debt approximates its fair value as the principal amounts outstanding are subject to variable interest rates that are based on market rates which are regularly reset. Cash and Cash Equivalents The Company classifies all highly liquid instruments with an original maturity of three Restricted Cash Restricted cash represents cash held at financial institutions that are pledged as collateral for stand-by letters of credit for lease and legal verdict commitments. The lease related letters of credit will lapse at the end of the respective lease terms through 2026. December 31, 2021 2020 2021 2020. Investment Securities The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities may 2016 13, Financial Instruments Credit Losses (Topic 326 No December 31, 2021 Assets Measured at Fair Value on a Recurring Basis ASC Topic 820, Fair Value Measurement (" 820" 820, 820 three 1 3 Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not Level 3: Valuations derived from valuation techniques in which one Following are the major categories of assets measured at fair value on a recurring basis as of December 31, 2021 2020 1 2 3 December 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents $ 50,872 $ — $ — $ 50,872 Commercial paper — 14,589 — 14,589 Corporate bonds — 4,386 — 4,386 Totals $ 50,872 $ 18,975 $ — $ 69,847 December 31, 2020 Level 1 Level 2 Level 3 Total Cash equivalents $ 59,919 $ 11,798 $ — $ 71,717 Commercial paper — 8,096 — 8,096 Totals $ 59,919 $ 19,894 $ — $ 79,813 The Company’s investments in commercial paper, corporate bonds and U.S. government securities are exposed to price fluctuations. The fair value measurements for commercial paper, corporate bonds and U.S. government securities are based upon the quoted prices of similar items in active markets multiplied by the number of securities owned. The following tables summarize the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Estimated December 31, 2021 (in years) cost Gains Losses fair value Cash equivalents $ 50,872 $ — $ — $ 50,872 Commercial paper Less than 1 14,590 — (1 ) 14,589 Corporate bonds 4,387 - (1 ) 4,386 Totals $ 69,849 $ — $ (2 ) $ 69,847 Maturity Amortized Unrealized Estimated December 31, 2020 (in years) cost Gains Losses fair value Cash equivalents $ 71,717 $ — $ — $ 71,717 Commercial paper Less than 1 8,096 — — 8,096 Totals $ 79,813 $ — $ — $ 79,813 Concentration of Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents, marketable securities, and accounts receivable, net. The Company’s cash and cash equivalents and restricted cash in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at December 31, 2021 not 1/P 1 The Company sells its products in the United States primarily through specialty pharmacies and specialty distributors. Therefore, wholesale distributors and large pharmacy chains account for a large portion of its accounts receivables, net and product revenues, net. The creditworthiness of its customers is continuously monitored, and the Company has internal policies regarding customer credit limits. The Company estimates an allowance for credit loss primarily based on the credit worthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions. The Company recorded credit loss expense of $1.0 million during 2020 2021. The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, NERLYNX, and expects NERLYNX to constitute the vast majority of product revenue for the foreseeable future. The Company relies exclusively on third third no not third third one third one third Inventory The Company values its inventories at the lower of cost and estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first first first may The Company capitalizes inventory costs associated with the Company’s products after regulatory approval, if any, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory that can be used in either the production of clinical or commercial product is recorded as research and development expense when selected for use in a clinical trial. Starter kits, provided to patients prior to insurance approval, are expensed by the Company to selling, general and administrative expense as incurred. The Company’s inventory balances are as follows: December 31, 2021 December 31, 2020 Raw materials $ 4,569 $ 1,431 Work-in-process (materials, labor and overhead) 1,385 1,258 Finished goods (materials, labor and overhead) 1,155 765 Total Inventories $ 7,109 $ 3,454 Property and Equipment, Net Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the useful lives of the assets, which is generally three three seven The Company reviews its long-lived assets used in operations for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not 360, Property, Plant, and Equipment 360" Leases ASC Topic 842, Leases first 2019, 360. two no Leases are classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. For additional information, see Note 7 The Company leases office space and copy machines, all of which are operating leases. Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. The leases do not The incremental borrowing rate ("IBR") represents the rate of interest the Company would expect to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. When determinable, the Company uses the rate implicit in the lease to determine the present value of lease payments. As the Company’s leases do not orrowing rate based on the information available at the commencement date in determining the present value of lease payments. The Company’s average IBR for existing leases as of December 31, 2021 was 10.9%. The Company decided to cease the use of a portion of its leased office space in 2019. 360. December 31, 2019. no December 31, 2021 License Fees and Intangible Assets The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no The Company maintains definite-lived intangible assets related to the license agreement with Pfizer. These assets are amortized over their remaining useful lives, which are estimated based on the shorter of the remaining patent life or the estimated useful life of the underlying product. Intangible assets are amortized using the economic consumption method if anticipated future revenues can be reasonably estimated. The straight-line method is used when future revenues cannot be reasonably estimated. Amortization costs are recorded as part of cost of sales. The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may one may July 2017, one June 2020, 14 2030. December 31, 2021, 2020 2019 December 31, 2021 2022 2029, 2030. Recently Issued Accounting Standards In June 2016, 2016 13, Financial Instruments - Credit Losses (Topic 326 2016 13" . 2016 13 2016 13 December 15, 2019. 2016 13 January 1, 2020, not In August 2018, No. 2018 13, Fair Value Measurement (Topic 820 2018 13" January 1, 2020, 2018 13, 2018 13 not In December 2019, No 2019 12, Income Taxes (Topic 740 2019 12" 2019 12 2019 12 December 15, 2020, 2019 12 January 1, 2021 not |
Note 3 - Accounts Receivable, N
Note 3 - Accounts Receivable, Net | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Accounts Receivable [Text Block] | Note 3—Accounts Accounts receivable, net consisted of the following (in thousands): December 31, 2021 December 31, 2020 Trade accounts receivable $ 29,646 $ 21,515 License revenue receivable — 2,500 Royalty revenue receivable 2,880 2,528 Total accounts receivable $ 32,526 $ 26,543 Allowance for credit losses — (1,000 ) Total accounts receivable, net $ 32,526 $ 25,543 Trade accounts receivable consist entirely of amounts owed from the Company’s customers related to product sales. License revenue receivable represents an amount owed from a sub-licensee under a sub-license agreement. Royalty revenue receivable represents amounts owed related to royalty revenue recognized based on the Company’s sub-licensees’ sales in their respective territories in the years ended December 31, 2021 2020 For all accounts receivable, the Company recognized credit losses based on lifetime expected losses. In determining estimated credit losses, the Company evaluated its historical loss rates, current economic conditions and reasonable and supportable forecasts of future economic conditions. The Company recorded a recovery of credit loss expense of $1.0 million and $1.0 million as a credit loss expense in the years ended December 31, 2021 2020 Allowance for credit losses (in thousands): Beginning balance at January 1, 2020 $ (1,000 ) Provision for credit loss expense — Accounts receivable written-off — Recoveries 1,000 Total ending allowance balance as December 31, 2021 $ — |
Note 4 - Prepaid Expenses and O
Note 4 - Prepaid Expenses and Other | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Prepaid Expense and Other Assets [Text Block] | Note 4—Prepaid Prepaid expenses and other consisted of the following at December 31 December 31, 2021 December 31, 2020 Current: CRO services $ 340 $ 1,550 Other clinical development 2,933 2,718 Insurance 3,178 3,708 Professional fees 398 651 Other 2,135 2,635 8,984 11,262 Long-term: CRO services 166 518 Other clinical development 577 437 Other 611 790 1,354 1,745 Totals $ 10,338 $ 13,007 Other current prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions and software. Other long-term prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions, software, a capitalized sublease commission and a sublease tenant improvement allowance, net of amortization. |
Note 5 - Other Current Assets
Note 5 - Other Current Assets | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Other Current Assets [Text Block] | Note 5—Other Other current assets consisted of the following at December 31 ( December 31, 2021 December 31, 2020 Deposit for manufacturing costs $ - $ 3,376 Other 447 265 Totals $ 447 $ 3,641 Other current asset amounts consist primarily of capitalized sublease commission and a sublease tenant improvement allowances, net of amortization. |
Note 6 - Property and Equipment
Note 6 - Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | Note 6—Property Property and equipment consisted of the following at December 31 December 31, 2021 December 31, 2020 Leasehold improvements $ 3,779 $ 3,779 Computer equipment 2,177 2,192 Telephone equipment 302 302 Furniture and fixtures 2,359 2,359 8,617 8,632 Less: accumulated depreciation (6,861 ) (6,151 ) Totals $ 1,756 $ 2,481 For the years ended December 31, 2021 2020 2019 |
Note 7 - Leases
Note 7 - Leases | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | Note 7—Leases In December 2011, November 2012, December 2013, March 2014, July 2015, December 2017. seven December 10, 2011. March 2026, In June 2012, May 2014 July 2015. March 2026, five The Company also leases copier equipment for use in the office spaces. Components of copier lease expense include both fixed and variable lease expenses. Total rent expense for each of the respective years ended December 31, 2021 2020 2019 was approximately $5.1 million. Fo first may not The future minimum lease payments under ASC 842 December 31, 2021 Amount 2022 $ 5,483 2023 5,631 2024 5,805 2025 5,983 2026 1,508 Total minimum lease payments $ 24,410 Less: imputed interest (4,861 ) Total lease liabilities $ 19,549 In February 2019, March 2026, December 31, 2021, 2020 2019 The future minimum lease payments to be received as of December 31, 2021 Amount 2022 $ 481 2023 495 2024 510 2025 525 2026 133 Total $ 2,144 Supplemental cash flow information related to leases for the year ended December 31, 2021 Operating cash flows used for operating leases (in thousands) $ 5,731 Right-of-use assets obtained in exchange for new operating lease liabilities — Weighted average remaining lease term (in years) 4.2 Weighted average discount rate 10.9 % |
Note 8 - Intangible Assets
Note 8 - Intangible Assets | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Intangible Assets Disclosure [Text Block] | Note 8—Intangible Intangible assets consisted of the following at December 31 December 31, 2021 December 31, 2020 Acquired and in-licensed rights $ 90,000 $ 90,000 Less: accumulated amortization (23,875 ) (15,860 ) Total intangible asset, net $ 66,125 $ 74,140 Estimated future intangible amortization expense as of December 31, 2021 2022 $ 8,015 2023 8,015 2024 8,015 2025 8,015 2026 8,015 Thereafter 26,050 Totals $ 66,125 |
Note 9 - Accrued Expenses
Note 9 - Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | Note 9—Accrued Accrued expenses consisted of the following at December 31 December 31, 2021 December 31, 2020 Current: Accrued legal verdict expense $ 57,137 $ 22,724 Accrued royalties 8,829 8,604 Accrued CRO services 2,663 3,474 Accrued variable consideration 11,406 9,014 Accrued bonus 5,083 7,788 Accrued compensation 3,878 4,820 Accrued other clinical development 911 1,904 Accrued professional fees 672 1,420 Accrued legal fees 674 383 Accrued manufacturing costs 690 752 Other 632 442 92,575 61,325 Long-term: Accrued legal verdict expense — 24,822 Accrued CRO services 878 908 Accrued other 37 233 915 25,963 Totals $ 93,490 $ 87,288 On October 29, 2021, Hsu v. Puma Biotechnology, Inc. et al, November 2, 2021, no $54.2 millio first January 2022 June 2022. Also included in accrued legal verdict expense is approximately $2.9 million that may Eshelman v. Puma Biotechnology, Inc., et al. rent liability due to the uncertainty of timing and amount of the payment. Accrued variable consideration represents estimates of adjustments to product revenue, net for which reserves are established. Accrued royalties represent royalties incurred in connection with the Company’s license agreement with Pfizer. Accrued CRO services, accrued other clinical development expenses, and accrued legal fees represent the Company’s estimates of such costs and are recognized as incurred. Accrued compensation includes commissions, vacation and restructuring costs. Other long-term accrued expenses consists primarily of business license fees, one Restructuring Costs On November 2, 2021, 19 December 31, 2021, $0.1 not first 2022. |
Note 10 - Debt
Note 10 - Debt | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 10—Debt Long-term debt consisted of the following at December 31, 2021 December 31, 2021 Maturity Date Total debt, inclusive of $ 2.0 $ 102,000 July 23, 2026 Less: deferred issuance costs and discounts (4,908 ) Total long-term debt, net $ 97,092 Oxford Loan and Security Agreement In October 2017, May 2018, December 2018, The term loans under the Amended Credit Facility bore interest at an annual rate equal to the greater of (i) 8.25% and (ii) the sum of (a) the “prime rate,” as reported in The Wall Street Journal on the last business day of the month that immediately preceded the month in which the interest accrued, plus (b) 3.5%. The Company was required to make monthly interest-only payments on each term loan commencing on the first first July 1, 2020. July 1, 2020, first May 1, 2023. On June 28, 2019, The New Credit Facility was secured by substantially all of the Company's personal property other than intellectual property. The Company also pledged 65% of the issued and outstanding capital stock of its subsidiaries, Puma Biotechnology Ltd. and Puma Biotechnology B.V. The New Credit Facility limited the Company's ability to grant any interest in intellectual property to certain permitted licenses and permitted encumbrances set forth in the agreement. The term loans under the New Credit Facility bore interest at an annual rate equal to the greater of (i) 9.0% and (ii) the sum of (a) the "primate rate" as reported in The Wall Street Journal on the last business day of the month that immediately preceded the month in which the interest will accrue, plus (b) 3.5%. The Company was required to make monthly interest-only payments on each term loan under the New Credit Facility commencing on the first first August 1, 2021, first June 1, 2024, December 31, 2020, The Company had the option to prepay the outstanding principal balance of any term loan in whole but not first first second second The New Credit Facility included affirmative and negative covenants applicable to the Company, its current subsidiaries and any subsidiaries the Company created in the future. The affirmative covenants included, among others, covenants requiring the Company to maintain its legal existence and governmental approvals, to deliver certain financial reports, to maintain insurance coverage and to satisfy certain requirements regarding deposit accounts. The Company was also required to achieve certain product revenue targets, measured as of the last day of each fiscal quarter on a trailing year to date basis. New minimum revenue levels were to be established for each subsequent fiscal year by mutual agreement of the Company, Oxford, as collateral agent, and the new lenders. The negative covenants included, among others, restrictions on the Company’s transferring of collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and suffering a change in control, in each case subject to certain exceptions. On February 27, 2020, March 31, June 30, September 30 December 31, 2020 2021. August 5, 2020 September 30 December 31, 2020. February 3, 2021, March 31, June 30, September 30 December 31, 2021. The New Credit Facility also included events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 5.0% and would have provided Oxford, as collateral agent, with the right to exercise remedies against the Company and the collateral securing the New Credit Facility, including foreclosure against the property securing the New Credit Facility, including the Company’s cash. These events of default included, among other things, the Company’s failure to pay principal or interest due under the New Credit Facility, a breach of certain covenants under the New Credit Facility, the Company’s insolvency, a material adverse change, the occurrence of any default under certain other indebtedness in an amount greater than $500,000 and one 10 On July 23, 2021, Athyrium Note Purchase Agreement The Company issued senior notes for an aggregate principal amount of $100.0 million pursuant to the note purchase agreement dated July 23, 2021, 1 July 23, 2026 ( $100.0 The Athyrium Notes bear interest at an annual rate equal to the sum of (i) 8.0% and (ii) three three March, June, September December June 30, 2024, December 31, 2021, 10.98%. At the Company’s option, the Company may second second second third The Athyrium Notes include affirmative and negative covenants applicable to the Company. The affirmative covenants include, among others, covenants requiring the Company to maintain its legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage, and satisfy certain requirements regarding deposit accounts. The negative covenants include, among others, restrictions on the Company’s transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and suffering a change in control, in each case subject to certain exceptions. Additionally, the Company may not first December 31, 2021 As of December 31, 2021 The future minimum principal and exit payments under the Athyrium Notes as of December 31, 2021 Amount 2022 $ — 2023 — 2024 33,997 2025 45,329 2026 22,674 Total $ 102,000 Debt Issuance Costs and Discounts Debt issuance costs and discounts consist of the following (in thousands): December 31, 2021 December 31, 2020 Debt issuance costs and discounts (Oxford Credit Facility) $ - $ 8,668 Debt issuance costs and discounts (Athyrium Notes) 5,410 - Less: accumulated amortization (502 ) (3,666 ) Included in long-term debt $ 4,908 $ 5,002 Debt issuance costs and discounts are financing costs related to the Company’s outstanding debt. Amortization of debt issuance costs is expensed using the effective interest method and is included in interest expense in the consolidated statements of operations. For the years ended December 31, 2021, 2020 2019 |
Note 11 - Stockholders' Deficit
Note 11 - Stockholders' Deficit | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 11—Stockholders’ Common Stock The Company issued 0, 18,202, and 87,625 shares of common stock upon exercise of stock options during the years ended December 31, 2021, 2020 2019 December 31, 2021, 2020 2019 Authorized Shares The Company has 100,000,000 shares of stock authorized for issuance, all of which are common stock, par value $0.0001 per share. Warrants In October 2011, In connection with the closing of a public offering in October 2012, October 4, 2021. April 1, 2021, October 4, 2026. June 15, 2021. As a result of this amendment, the Company recorded additional stock-based compensation in the amount of $13.6 million which was included in the selling, general and administrative expense for the year ended December 31, 2021 2 June 15, 2021, Dividend yield 0.0 % Expected volatility 87.0 % Risk-free interest rate 0.8 % Expected life in years 5.31 Stock Options and Restricted Stock Units The Company’s 2011 "2011 September 15, 2011. 2011 may may 2011 2011 10 three 2011 April 1, 2021, 2011 June 15, 2021. December 31, 2021 2011 As of December 31, 2021 5,068,592 2011 s 2011 107, Share Based Payment 2 December 31: 2021 2020 Dividend yield 0.0 % 0.0 % Expected volatility 86.6 % 100.6 % Risk-free interest rate 0.8 % 0.9 % Expected life in years 5.82 5.81 The Company’s 2017 "2017 April 27, 2017. 2017 may 2017 three 2017 July 15, 2021, 2017 December 31, 2021 2017 December 31, 2021 2017 2017 Stock-based compensation expense was as follows for the years ended December 31 For the Year Ended December 31, 2021 2020 2019 Stock-based compensation: Options - Selling, general, and administrative $ 3,873 $ 3,937 $ 9,044 Research and development 573 3,018 7,452 Restricted stock units - Selling, general, and administrative 8,239 13,841 18,848 Research and development 6,361 15,779 21,983 Warrant Modification - Selling, general, and administrative 13,587 - - Total stock-based compensation expense $ 32,633 $ 36,575 $ 57,327 Activity with respect to options granted under the 2011 2017 Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2019 5,042,325 $ 82.42 5.2 $ 1,951 Granted 700,853 $ 10.03 9.2 $ - Exercised (18,202 ) $ 3.75 $ 119 Expired (715,634 ) $ 90.51 $ - Outstanding at December 31, 2020 5,009,342 $ 71.42 5.1 $ 3,458 Granted 640,748 $ 11.12 8.2 $ - Forfeited (186,339 ) $ 10.60 $ - Expired (868,504 ) $ 87.55 $ - Outstanding at December 31, 2021 4,595,247 $ 62.43 4.5 $ - Nonvested at December 31, 2021 835,297 $ 10.64 8.9 $ - Exercisable 3,759,950 $ 73.93 3.6 $ - At December 31, 2021 December 31, 2021 December 31, 2021, 2020 2019 December 31, 2021, 2020 2019 Stock Option Rollforward Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2019 439,194 $ 19.38 Granted 700,853 $ 7.81 Vested/Issued (240,375 ) $ 25.57 Nonvested shares at December 31, 2020 899,672 $ 8.71 Granted 640,748 $ 7.90 Vested/Issued (518,784 ) $ 9.51 Forfeited (186,339 ) $ 7.96 Nonvested shares at December 31, 2021 835,297 $ 7.76 Restricted Stock Unit Rollforward Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2019 1,991,125 $ 27.63 Granted 1,234,616 $ 10.47 Vested/Issued (864,881 ) $ 36.86 Forfeited (506,655 ) $ 21.72 Nonvested shares at December 31, 2020 1,854,205 $ 13.51 Granted 1,409,733 $ 11.44 Vested/Issued (1,089,120 ) $ 14.99 Forfeited (775,501 ) $ 12.13 Nonvested shares at December 31, 2021 1,399,317 $ 11.03 |
Note 12 - 401(k) Savings Plan
Note 12 - 401(k) Savings Plan | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Compensation and Employee Benefit Plans [Text Block] | Note 12—401 During 2012, 401 401 first 3% 2% December 31, 2021, 2020 2019 |
Note 13 - Income Taxes
Note 13 - Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 13—Income The Company uses the asset and liability method of accounting for income taxes in accordance with ASC Topic 740, December 31 2021 2020 2019 Current: Federal $ - $ - $ - State 77 124 53 Foreign 247 83 - 324 207 53 Deferred: Federal - - - State - - - - - - Total $ 324 $ 207 $ 53 The provision for income taxes in the accompanying consolidated statements of operations differs from the amount calculated by applying the statutory income tax rate to loss from continuing operations before income taxes. Approximately $22.5 million of tax expense for the year ended December 31, 2021 December 31, 2021 December 31 ( 2021 2020 2019 Tax computed at the federal statutory rate $ (6,045 ) $ (12,540 ) $ (15,830 ) State taxes (1,072 ) (2,304 ) (2,453 ) Foreign taxes 247 83 — Permanent items 22,689 13,660 21,834 R&D credits (3,941 ) (5,231 ) (14,946 ) Prior year adjustment 916 (2,116 ) (2,792 ) Change in valuation allowance (12,470 ) 8,655 14,240 Total provision $ 324 $ 207 $ 53 Temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes give rise to the Company’s deferred income taxes. The components of the Company’s net deferred tax assets are as follows as of December 31 ( 2021 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 258,390 $ 261,472 $ 260,555 Business credit carryforwards 59,514 55,574 50,343 Compensation 40,647 58,112 60,967 Accrued legal verdict 14,144 11,880 7,624 Carryforward of disallowed interest 4,537 3,093 2,839 Accrued expenses 104 561 9 Lease liabilities 4,839 5,657 6,145 Other deferred tax assets 1,306 804 13 Subtotal 383,481 397,153 388,495 Deferred tax liabilities: Lease right-of-use assets (3,470 ) (4,099 ) (4,505 ) Inventory 406 (21 ) — Other deferred tax liabilities (318 ) (464 ) (76 ) Subtotal (3,382 ) (4,584 ) (4,581 ) Total deferred tax assets 380,099 392,569 383,914 Valuation allowance (380,099 ) (392,569 ) (383,914 ) Net deferred tax assets $ — $ — $ — As the ultimate realization of the potential benefits of the Company’s deferred tax assets is considered unlikely by management, the Company has offset the deferred tax assets attributable to those potential benefits through valuation allowances. Accordingly, the Company did not December 31, 2021 2020, December 31, 2021, 2033. December 31, 2021, not 2033. not 382 383, 50% three no 2021. The following is a tabular reconciliation of the total amounts of unrecognized tax benefits at December 31 ( 2021 2020 2019 Unrecognized tax benefits - January 1 $ 3,276 $ 1,968 $ 8,777 Gross decreases - tax positions in a prior period — — (8,422 ) Gross increases - tax positions in a current period 985 1,308 1,613 Unrecognized tax benefits - December 31 $ 4,261 $ 3,276 $ 1,968 During the year ended December 31, 2019, no December 31, 2021 The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by the federal and state jurisdictions where applicable. There are currently no 2009 |
Note 14 - Commitments and Conti
Note 14 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | Note 14—Commitments License Agreement In August 2011, PB272 PB272 PB357, one December 31, 2011, fourth 2012. December 31, 2013. On July 18, 2014, January 1, 2014 As consideration for the license, the Company is required to make substantial payments upon the achievement of certain milestones totaling approximately $187.5 million if all such milestones are achieved, of which $90.0 million have been achieved as of December 31, 2021. July 2017, one June 2020, one September 2021. may first third Clinical Trial Contracts The Company engages with CROs and contract manufacturing organizations ("CMOs") in addition to eng aging in contracts for the management of its ongoing clinical trials and pre-commercialization efforts. The Company may twelve not December 31, 2021 one Legal Proceedings The Company and certain of its executive officers were named as defendants in the lawsuits detailed below. The Company records a liability in the consolidated financial statements for loss contingencies when a loss is known or considered probable and the amount can be reasonably estimated. If the reasonable estimate of a known or probable loss is a range, and no not Currently, the Company has accrued estimated losses of $54.2 million related to Hsu v. Puma Biotechnology, Inc., et al., and $2.9 million related to Eshelman v. Puma Biotechnology, Inc., et al. as detailed below. For certain legal expenses related to the verdicts listed below, the Company has received reimbursements from its insurers. Hsu v. Puma Biotechnology, Inc., et al. On June 3, 2015, No. 8:15 00865 October 16, 2015, July 22, 2014 May 29, 2015. four January 15, 2019 January 29, 2019. three four not one September 9, 2019, 52 September 8, 2020, October 9, 2020, November 27, 2020, On October 29, 2021, November 2, 2021, no two January June 2022. It is reasonably possible that the final total damages awarded will differ from these estimates; however, the amount is not not first January 2022, 15 Eshelman v. Puma Biotechnology, Inc., et al. In February 2016, No. 7:16 00018 May 2016, March 11 March 15, 2019. April 22, 2019, March 2, 2020. March 2020 March 30, 2020, June 23, 2021, Eshelman v. Puma Biotechnology, et al July 7, 2021, July 20, 2021. July 26, 2021, July 29, 2021. October 18, 2021, December 13, 2021. Due to the appeal, the Company secured a bond for the potential damages, which is collateralized by an automatically renewable stand-by letter of credit in the amount of $8.9 million. The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, current on the accompanying consolidated balance sheets. CANbridge Licensing Dispute On July 28, 2020, August 26, 2020, February 24, 2021, Legal Malpractice Suits On September 17, 2020, Eshelman v. Puma Biotechnology, Inc., et al. Eshelman v. Puma Biotechnology, Inc., et al Eshelman v. Puma Biotechnology, Inc., et al. November 23, 2020, On June 23, 2021, Eshelman v. Puma Biotechnology, Inc., et al October 7, 2021, six may Patent-Related Proceedings AstraZeneca Litigation On September 22, 2021, 10,603,314 '314 10,596,162 '162 Puma Biotechnology, Inc. et al. v. AstraZeneca Pharmaceuticals LP et al 1:21CV01338 Sep. 22, 2021)). '314 '162 '314 '162 November 5, 2021, not December 10, 2021, December 13, 2021. December 17, 2021. February 9, 2022. February 15, 2022. February 17, 2022, May 13, 2024. Sandoz Litigation On November 10, 2021, No. 7,399,865 B2 '865 Puma Biotechnology, Inc. et al. v. Sandoz Inc. 1:21CV19918 Nov. 10, 2021) ) 45 40 '865 ‘865 35 271 4 no ‘865 November 21, 2030 '865 '865 '865 January 14, 2022 ‘865 February 4, 2022. February 15, 2022 February 18, 2022. 30 China Litigation On January 18, 2022, three 4.2 not January 19, 2022. 45 nine nine |
Note 15 - Subsequent Events
Note 15 - Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 15—Subsequent In January 2022, first two 14 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Reclassification, Comparability Adjustment [Policy Text Block] | Reclassifications In preparing the 2021 December 31, 2020. not |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of revenues and expenses for the period presented. Accordingly, actual results could differ from those estimates. Significant estimates include estimates for variable consideration for which reserves were established. These estimates are included in the calculation of net revenues and include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products. Other significant estimates also include those related to legal and other expense accruals. |
Earnings Per Share, Policy [Policy Text Block] | Net Loss per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the periods presented, as required by ASC 260 not For the Years Ended December 31, 2021 2020 2019 Options outstanding 4,595,247 5,009,342 5,042,325 Warrant outstanding 2,116,250 2,116,250 2,116,250 Unvested restricted stock units 1,399,317 1,854,205 1,991,125 Totals 8,110,814 8,979,797 9,149,700 |
Revenue [Policy Text Block] | Revenue Recognition Under ASC Topic 606, Revenue from Contracts with Customers 606" no July 17, 2017. Product Revenue, Net The Company sells NERLYNX to a limited number of specialty pharmacies and specialty distributors in the United States. These customers subsequently resell the Company’s products to patients and certain medical centers or hospitals. In addition to distribution agreements with these customers, the Company enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the specialty pharmacy or specialty distributor, as applicable, obtains control of the Company's product, which occurs at a point in time (upon delivery). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 10 68 Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods and are recorded in cost of sales. If taxes should be collected from customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one no December 31, 2021 For the period ended December 31, 2021 December 31, 2020 December 31, 2019 Reserves for Variable Consideration Revenue from product sales is recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the related sales, and are classified as reductions of accounts receivable, net when the right of offset exists in accordance with ASU 2013 1, Balance Sheet (Topic 210 606 The amount of variable consideration that is included in the transaction price may not not December 31, 2021 not December 31, 2021 may Trade Discounts and Allowances The Company generally provides customers with discounts, which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. The reserve for discounts is established in the same period that the related revenue is recognized, together with reductions to accounts receivables, net on the consolidated balance sheets. In addition, the Company compensates its customers for sales order management, data, and distribution services. The Company has determined such services received to date are not Product Returns Consistent with industry practice, the Company offers the specialty pharmacies and specialty distributors that are its customers limited product return rights for damaged and expiring product, provided it is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company estimates the amount of its product sales that may Provider Chargebacks and Discounts Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to its customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. The reserve for chargebacks is established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and a reduction to accounts receivable, net on the consolidated balance sheets. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the customer’s notification to the Company of the resale. Chargebacks consist of credits the Company expects to issue for units that remain in the distribution channel at each reporting period end that the Company expects will be sold to qualified healthcare providers and chargebacks that customers have claimed, but for which the Company has not Government Rebates The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheets. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not not Payor Rebates The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue, net and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheets. Other Incentives Other incentives the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses on the consolidated balance sheets. License Revenue The Company also recognizes license revenue under certain of the Company’s sub-license agreements that are within the scope of ASC 606. may may 606 not no not 45 Prior to recognizing revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not If there are multiple distinct performance obligations, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined based on the prices charged to customers or using expected cost-plus margin. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure. Since 2018, License fees under the sub-license agreements include one one December 31, 2021 Royalty Revenue For sub-license agreements that are within the scope of ASC 606, 606 10 55 65. 30 90 |
Segment Reporting, Policy [Policy Text Block] | Segment Reporting Management has determined that the Company operates in one |
Legal Costs, Policy [Policy Text Block] | Legal Contingencies and Expense For legal contingencies, the Company accrues a liability for an estimated loss if the potential loss from any claim or legal proceeding is considered probable and the amount can be reasonably estimated. Legal fees and expenses are expensed as incurred based on invoices or estimates provided by legal counsel. The Company periodically evaluates available information, both internal and external, relative to such contingencies and adjusts the accrual as necessary. The Company determines whether a contingency should be disclosed by assessing whether a material loss is deemed reasonably possible. In determining whether a loss should be accrued, the Company evaluates, among other factors, the degree of probability of an unfavorable outcome and the ability to make a reasonable estimate of the amount of the loss (see Note 14 |
Royalties, Policy [Policy Text Block] | Royalty Expenses Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 14 |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses Research and development ("R&D") expenses are charged to operations as incurred. The major components of research and development costs include clinical manufacturing costs, clinical trial expenses, consulting and other third not third may In instances where the Company enters into agreements with third not may may Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development costs. |
Share-based Payment Arrangement [Policy Text Block] | Stock-Based Compensation Stock option awards ASC Topic 718, Compensation-Stock Compensation 718" 718, not 718, six Restricted stock units RSUs are valued on the grant date and the fair value of the RSUs is equal to the market price of the Company’s common stock on the grant date. The RSU expense is recognized over the requisite service period in the statement of operations. When the requisite service period begins prior to the grant date (because the service inception date occurs prior to the grant date), the Company is required to begin recognizing compensation cost before there is a measurement date (i.e., the grant date). The service inception date is the beginning of the requisite service period. If the service inception date precedes the grant date, accrual of compensation cost for periods before the grant date shall be based on the fair value of the award at the reporting date. In the period in which the grant date occurs, cumulative compensation cost shall be adjusted to reflect the cumulative effect of measuring compensation cost based on fair value at the grant date rather than the fair value previously used at the service inception date (or any subsequent reporting date). RSU forfeitures are estimated when the RSU is granted to reduce the RSU expense to be recognized over the life of the award. The estimated forfeiture rate considers historical employee turnover rates stratified into employee pools, actual forfeiture experience and other factors. The RSU expense is “trued-up” upon the actual forfeiture of a RSU grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates. Compensation expense related to modified restricted stock units is measured based on the fair value for the awards as of the modification date. Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite service period, as appropriate. Warrants Warrants (see Note 11 718, nine |
Income Tax, Policy [Policy Text Block] | Income Taxes The Company follows ASC Topic 740, Income Taxes 740" not not The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the consolidated financial statements. Under ASC 740, may not 50% 740 uidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. As of December 31, 2021 , the Company’s uncertain tax position includes a reserve for its R&D credits. |
Financial Instruments [Policy Text Block] | Financial Instruments The carrying value of financial instruments, such as cash equivalents, accounts receivable and accounts payable, approximate their fair value because of their short-term nature. The carrying value of long-term debt approximates its fair value as the principal amounts outstanding are subject to variable interest rates that are based on market rates which are regularly reset. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company classifies all highly liquid instruments with an original maturity of three |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash Restricted cash represents cash held at financial institutions that are pledged as collateral for stand-by letters of credit for lease and legal verdict commitments. The lease related letters of credit will lapse at the end of the respective lease terms through 2026. December 31, 2021 2020 2021 2020. |
Marketable Securities, Policy [Policy Text Block] | Investment Securities The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities may 2016 13, Financial Instruments Credit Losses (Topic 326 No December 31, 2021 |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Assets Measured at Fair Value on a Recurring Basis ASC Topic 820, Fair Value Measurement (" 820" 820, 820 three 1 3 Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not Level 3: Valuations derived from valuation techniques in which one Following are the major categories of assets measured at fair value on a recurring basis as of December 31, 2021 2020 1 2 3 December 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents $ 50,872 $ — $ — $ 50,872 Commercial paper — 14,589 — 14,589 Corporate bonds — 4,386 — 4,386 Totals $ 50,872 $ 18,975 $ — $ 69,847 December 31, 2020 Level 1 Level 2 Level 3 Total Cash equivalents $ 59,919 $ 11,798 $ — $ 71,717 Commercial paper — 8,096 — 8,096 Totals $ 59,919 $ 19,894 $ — $ 79,813 The Company’s investments in commercial paper, corporate bonds and U.S. government securities are exposed to price fluctuations. The fair value measurements for commercial paper, corporate bonds and U.S. government securities are based upon the quoted prices of similar items in active markets multiplied by the number of securities owned. The following tables summarize the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Estimated December 31, 2021 (in years) cost Gains Losses fair value Cash equivalents $ 50,872 $ — $ — $ 50,872 Commercial paper Less than 1 14,590 — (1 ) 14,589 Corporate bonds 4,387 - (1 ) 4,386 Totals $ 69,849 $ — $ (2 ) $ 69,847 Maturity Amortized Unrealized Estimated December 31, 2020 (in years) cost Gains Losses fair value Cash equivalents $ 71,717 $ — $ — $ 71,717 Commercial paper Less than 1 8,096 — — 8,096 Totals $ 79,813 $ — $ — $ 79,813 |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents, marketable securities, and accounts receivable, net. The Company’s cash and cash equivalents and restricted cash in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at December 31, 2021 not 1/P 1 The Company sells its products in the United States primarily through specialty pharmacies and specialty distributors. Therefore, wholesale distributors and large pharmacy chains account for a large portion of its accounts receivables, net and product revenues, net. The creditworthiness of its customers is continuously monitored, and the Company has internal policies regarding customer credit limits. The Company estimates an allowance for credit loss primarily based on the credit worthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions. The Company recorded credit loss expense of $1.0 million during 2020 2021. The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, NERLYNX, and expects NERLYNX to constitute the vast majority of product revenue for the foreseeable future. The Company relies exclusively on third third no not third third one third one third |
Inventory, Policy [Policy Text Block] | Inventory The Company values its inventories at the lower of cost and estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first first first may The Company capitalizes inventory costs associated with the Company’s products after regulatory approval, if any, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory that can be used in either the production of clinical or commercial product is recorded as research and development expense when selected for use in a clinical trial. Starter kits, provided to patients prior to insurance approval, are expensed by the Company to selling, general and administrative expense as incurred. The Company’s inventory balances are as follows: December 31, 2021 December 31, 2020 Raw materials $ 4,569 $ 1,431 Work-in-process (materials, labor and overhead) 1,385 1,258 Finished goods (materials, labor and overhead) 1,155 765 Total Inventories $ 7,109 $ 3,454 |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment, Net Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the useful lives of the assets, which is generally three three seven The Company reviews its long-lived assets used in operations for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not 360, Property, Plant, and Equipment 360" |
Lessee, Leases [Policy Text Block] | Leases ASC Topic 842, Leases first 2019, 360. two no Leases are classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. For additional information, see Note 7 The Company leases office space and copy machines, all of which are operating leases. Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. The leases do not The incremental borrowing rate ("IBR") represents the rate of interest the Company would expect to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. When determinable, the Company uses the rate implicit in the lease to determine the present value of lease payments. As the Company’s leases do not orrowing rate based on the information available at the commencement date in determining the present value of lease payments. The Company’s average IBR for existing leases as of December 31, 2021 was 10.9%. The Company decided to cease the use of a portion of its leased office space in 2019. 360. December 31, 2019. no December 31, 2021 |
License Fees and Intangible Assets [Policy Text Block] | License Fees and Intangible Assets The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no The Company maintains definite-lived intangible assets related to the license agreement with Pfizer. These assets are amortized over their remaining useful lives, which are estimated based on the shorter of the remaining patent life or the estimated useful life of the underlying product. Intangible assets are amortized using the economic consumption method if anticipated future revenues can be reasonably estimated. The straight-line method is used when future revenues cannot be reasonably estimated. Amortization costs are recorded as part of cost of sales. The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may one may July 2017, one June 2020, 14 2030. December 31, 2021, 2020 2019 December 31, 2021 2022 2029, 2030. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued Accounting Standards In June 2016, 2016 13, Financial Instruments - Credit Losses (Topic 326 2016 13" . 2016 13 2016 13 December 15, 2019. 2016 13 January 1, 2020, not In August 2018, No. 2018 13, Fair Value Measurement (Topic 820 2018 13" January 1, 2020, 2018 13, 2018 13 not In December 2019, No 2019 12, Income Taxes (Topic 740 2019 12" 2019 12 2019 12 December 15, 2020, 2019 12 January 1, 2021 not |
Note 2 - Significant Accounti_2
Note 2 - Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | For the Years Ended December 31, 2021 2020 2019 Options outstanding 4,595,247 5,009,342 5,042,325 Warrant outstanding 2,116,250 2,116,250 2,116,250 Unvested restricted stock units 1,399,317 1,854,205 1,991,125 Totals 8,110,814 8,979,797 9,149,700 |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | December 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents $ 50,872 $ — $ — $ 50,872 Commercial paper — 14,589 — 14,589 Corporate bonds — 4,386 — 4,386 Totals $ 50,872 $ 18,975 $ — $ 69,847 December 31, 2020 Level 1 Level 2 Level 3 Total Cash equivalents $ 59,919 $ 11,798 $ — $ 71,717 Commercial paper — 8,096 — 8,096 Totals $ 59,919 $ 19,894 $ — $ 79,813 |
Cash, Cash Equivalents and Investments [Table Text Block] | Maturity Amortized Unrealized Estimated December 31, 2021 (in years) cost Gains Losses fair value Cash equivalents $ 50,872 $ — $ — $ 50,872 Commercial paper Less than 1 14,590 — (1 ) 14,589 Corporate bonds 4,387 - (1 ) 4,386 Totals $ 69,849 $ — $ (2 ) $ 69,847 Maturity Amortized Unrealized Estimated December 31, 2020 (in years) cost Gains Losses fair value Cash equivalents $ 71,717 $ — $ — $ 71,717 Commercial paper Less than 1 8,096 — — 8,096 Totals $ 79,813 $ — $ — $ 79,813 |
Schedule of Inventory, Current [Table Text Block] | December 31, 2021 December 31, 2020 Raw materials $ 4,569 $ 1,431 Work-in-process (materials, labor and overhead) 1,385 1,258 Finished goods (materials, labor and overhead) 1,155 765 Total Inventories $ 7,109 $ 3,454 |
Note 3 - Accounts Receivable,_2
Note 3 - Accounts Receivable, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Accounts Receivable [Table Text Block] | December 31, 2021 December 31, 2020 Trade accounts receivable $ 29,646 $ 21,515 License revenue receivable — 2,500 Royalty revenue receivable 2,880 2,528 Total accounts receivable $ 32,526 $ 26,543 Allowance for credit losses — (1,000 ) Total accounts receivable, net $ 32,526 $ 25,543 |
Accounts Receivable, Allowance for Credit Loss [Table Text Block] | Allowance for credit losses (in thousands): Beginning balance at January 1, 2020 $ (1,000 ) Provision for credit loss expense — Accounts receivable written-off — Recoveries 1,000 Total ending allowance balance as December 31, 2021 $ — |
Note 4 - Prepaid Expenses and_2
Note 4 - Prepaid Expenses and Other (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Prepaid Expense and Other Assets [TableText Block] | December 31, 2021 December 31, 2020 Current: CRO services $ 340 $ 1,550 Other clinical development 2,933 2,718 Insurance 3,178 3,708 Professional fees 398 651 Other 2,135 2,635 8,984 11,262 Long-term: CRO services 166 518 Other clinical development 577 437 Other 611 790 1,354 1,745 Totals $ 10,338 $ 13,007 |
Note 5 - Other Current Assets (
Note 5 - Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Other Current Assets [Table Text Block] | December 31, 2021 December 31, 2020 Deposit for manufacturing costs $ - $ 3,376 Other 447 265 Totals $ 447 $ 3,641 |
Note 6 - Property and Equipme_2
Note 6 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, 2021 December 31, 2020 Leasehold improvements $ 3,779 $ 3,779 Computer equipment 2,177 2,192 Telephone equipment 302 302 Furniture and fixtures 2,359 2,359 8,617 8,632 Less: accumulated depreciation (6,861 ) (6,151 ) Totals $ 1,756 $ 2,481 |
Note 7 - Leases (Tables)
Note 7 - Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Amount 2022 $ 5,483 2023 5,631 2024 5,805 2025 5,983 2026 1,508 Total minimum lease payments $ 24,410 Less: imputed interest (4,861 ) Total lease liabilities $ 19,549 |
Lessor, Operating Lease, Payment to be Received, Fiscal Year Maturity [Table Text Block] | Amount 2022 $ 481 2023 495 2024 510 2025 525 2026 133 Total $ 2,144 |
Lessee, Operating Leases Related To Supplemental Cash Flow Information [Table Text Block] | Operating cash flows used for operating leases (in thousands) $ 5,731 Right-of-use assets obtained in exchange for new operating lease liabilities — Weighted average remaining lease term (in years) 4.2 Weighted average discount rate 10.9 % |
Note 8 - Intangible Assets (Tab
Note 8 - Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Finite-Lived Intangible Assets [Table Text Block] | December 31, 2021 December 31, 2020 Acquired and in-licensed rights $ 90,000 $ 90,000 Less: accumulated amortization (23,875 ) (15,860 ) Total intangible asset, net $ 66,125 $ 74,140 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block] | 2022 $ 8,015 2023 8,015 2024 8,015 2025 8,015 2026 8,015 Thereafter 26,050 Totals $ 66,125 |
Note 9 - Accrued Expenses (Tabl
Note 9 - Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 2021 December 31, 2020 Current: Accrued legal verdict expense $ 57,137 $ 22,724 Accrued royalties 8,829 8,604 Accrued CRO services 2,663 3,474 Accrued variable consideration 11,406 9,014 Accrued bonus 5,083 7,788 Accrued compensation 3,878 4,820 Accrued other clinical development 911 1,904 Accrued professional fees 672 1,420 Accrued legal fees 674 383 Accrued manufacturing costs 690 752 Other 632 442 92,575 61,325 Long-term: Accrued legal verdict expense — 24,822 Accrued CRO services 878 908 Accrued other 37 233 915 25,963 Totals $ 93,490 $ 87,288 |
Note 10 - Debt (Tables)
Note 10 - Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Debt [Table Text Block] | December 31, 2021 Maturity Date Total debt, inclusive of $ 2.0 $ 102,000 July 23, 2026 Less: deferred issuance costs and discounts (4,908 ) Total long-term debt, net $ 97,092 |
Schedule of Maturities of Long-term Debt [Table Text Block] | Amount 2022 $ — 2023 — 2024 33,997 2025 45,329 2026 22,674 Total $ 102,000 |
Schedule of Deferred Financing Costs [Table Text Block] | December 31, 2021 December 31, 2020 Debt issuance costs and discounts (Oxford Credit Facility) $ - $ 8,668 Debt issuance costs and discounts (Athyrium Notes) 5,410 - Less: accumulated amortization (502 ) (3,666 ) Included in long-term debt $ 4,908 $ 5,002 |
Note 11 - Stockholders' Defic_2
Note 11 - Stockholders' Deficit (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2021 2020 Dividend yield 0.0 % 0.0 % Expected volatility 86.6 % 100.6 % Risk-free interest rate 0.8 % 0.9 % Expected life in years 5.82 5.81 |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | For the Year Ended December 31, 2021 2020 2019 Stock-based compensation: Options - Selling, general, and administrative $ 3,873 $ 3,937 $ 9,044 Research and development 573 3,018 7,452 Restricted stock units - Selling, general, and administrative 8,239 13,841 18,848 Research and development 6,361 15,779 21,983 Warrant Modification - Selling, general, and administrative 13,587 - - Total stock-based compensation expense $ 32,633 $ 36,575 $ 57,327 |
Share-based Payment Arrangement, Activity [Table Text Block] | Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2019 5,042,325 $ 82.42 5.2 $ 1,951 Granted 700,853 $ 10.03 9.2 $ - Exercised (18,202 ) $ 3.75 $ 119 Expired (715,634 ) $ 90.51 $ - Outstanding at December 31, 2020 5,009,342 $ 71.42 5.1 $ 3,458 Granted 640,748 $ 11.12 8.2 $ - Forfeited (186,339 ) $ 10.60 $ - Expired (868,504 ) $ 87.55 $ - Outstanding at December 31, 2021 4,595,247 $ 62.43 4.5 $ - Nonvested at December 31, 2021 835,297 $ 10.64 8.9 $ - Exercisable 3,759,950 $ 73.93 3.6 $ - |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value [Table Text Block] | Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2019 439,194 $ 19.38 Granted 700,853 $ 7.81 Vested/Issued (240,375 ) $ 25.57 Nonvested shares at December 31, 2020 899,672 $ 8.71 Granted 640,748 $ 7.90 Vested/Issued (518,784 ) $ 9.51 Forfeited (186,339 ) $ 7.96 Nonvested shares at December 31, 2021 835,297 $ 7.76 |
Share-based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block] | Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2019 1,991,125 $ 27.63 Granted 1,234,616 $ 10.47 Vested/Issued (864,881 ) $ 36.86 Forfeited (506,655 ) $ 21.72 Nonvested shares at December 31, 2020 1,854,205 $ 13.51 Granted 1,409,733 $ 11.44 Vested/Issued (1,089,120 ) $ 14.99 Forfeited (775,501 ) $ 12.13 Nonvested shares at December 31, 2021 1,399,317 $ 11.03 |
Warrant [Member] | |
Notes Tables | |
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block] | Dividend yield 0.0 % Expected volatility 87.0 % Risk-free interest rate 0.8 % Expected life in years 5.31 |
Note 13 - Income Taxes (Tables)
Note 13 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | 2021 2020 2019 Current: Federal $ - $ - $ - State 77 124 53 Foreign 247 83 - 324 207 53 Deferred: Federal - - - State - - - - - - Total $ 324 $ 207 $ 53 |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | 2021 2020 2019 Tax computed at the federal statutory rate $ (6,045 ) $ (12,540 ) $ (15,830 ) State taxes (1,072 ) (2,304 ) (2,453 ) Foreign taxes 247 83 — Permanent items 22,689 13,660 21,834 R&D credits (3,941 ) (5,231 ) (14,946 ) Prior year adjustment 916 (2,116 ) (2,792 ) Change in valuation allowance (12,470 ) 8,655 14,240 Total provision $ 324 $ 207 $ 53 |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | 2021 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 258,390 $ 261,472 $ 260,555 Business credit carryforwards 59,514 55,574 50,343 Compensation 40,647 58,112 60,967 Accrued legal verdict 14,144 11,880 7,624 Carryforward of disallowed interest 4,537 3,093 2,839 Accrued expenses 104 561 9 Lease liabilities 4,839 5,657 6,145 Other deferred tax assets 1,306 804 13 Subtotal 383,481 397,153 388,495 Deferred tax liabilities: Lease right-of-use assets (3,470 ) (4,099 ) (4,505 ) Inventory 406 (21 ) — Other deferred tax liabilities (318 ) (464 ) (76 ) Subtotal (3,382 ) (4,584 ) (4,581 ) Total deferred tax assets 380,099 392,569 383,914 Valuation allowance (380,099 ) (392,569 ) (383,914 ) Net deferred tax assets $ — $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | 2021 2020 2019 Unrecognized tax benefits - January 1 $ 3,276 $ 1,968 $ 8,777 Gross decreases - tax positions in a prior period — — (8,422 ) Gross increases - tax positions in a current period 985 1,308 1,613 Unrecognized tax benefits - December 31 $ 4,261 $ 3,276 $ 1,968 |
Note 1 - Business and Basis o_2
Note 1 - Business and Basis of Presentation (Details Textual) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Number of Subsidiaries | 2 | ||
Net Income (Loss) Attributable to Parent, Total | $ (29,126) | $ (59,995) | $ (75,595) |
Net Cash Provided by (Used in) Operating Activities, Total | 20,650 | $ 773 | $ 22,376 |
Cash, Cash Equivalents, and Marketable Securities | $ 82,100 |
Note 2 - Significant Accounti_3
Note 2 - Significant Accounting Policies (Details Textual) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jan. 21, 2021USD ($) | |
Payments to Acquire Intangible Assets | $ 0 | $ 10,000 | $ 0 | |
Net Cash Provided by (Used in) Investing Activities, Total | (10,881) | 33,403 | 5,163 | |
Sublease Agreement, Potential Milestone Payments | $ 579,800 | |||
Restricted Cash, Total | 12,200 | 12,200 | ||
Cash and Cash Equivalents, and Restricted Cash In Excess of Insured Limits | 75,000 | |||
Accounts Receivable, Credit Loss Expense (Reversal) | 0 | 1,000 | 0 | |
Accounts Receivable, Allowance for Credit Loss, Recovery | $ 1,000 | |||
Average Incremental Borrowing Rate | 10.90% | |||
Operating Lease, Impairment Loss | $ 0 | |||
Amortization of Intangible Assets, Total | 8,000 | $ 6,300 | 3,900 | |
Finite-Lived Intangible Asset, Expected Amortization, Year One | 8,015 | |||
Finite-Lived Intangible Asset, Expected Amortization, Year Two | 8,015 | |||
Finite-Lived Intangible Asset, Expected Amortization, Year Three | 8,015 | |||
Finite-Lived Intangible Asset, Expected Amortization, Year Nine | 2,000 | |||
Finite-Lived Intangible Asset, Expected Amortization, Year Four | 8,015 | |||
Finite-Lived Intangible Asset, Expected Amortization, Year Five | 8,015 | |||
Finite-Lived Intangible Asset, Expected Amortization, Year Six | 8,000 | |||
Finite-Lived Intangible Asset, Expected Amortization, Year Seven | 8,000 | |||
Finite-Lived Intangible Asset, Expected Amortization, Year Eight | $ 8,000 | |||
Selling, General and Administrative Expenses [Member] | ||||
Operating Lease, Impairment Loss | $ 1,200 | |||
Computer Equipment [Member] | ||||
Property, Plant and Equipment, Useful Life (Year) | 3 years | |||
Telephone Equipment [Member] | ||||
Property, Plant and Equipment, Useful Life (Year) | 3 years | |||
Furniture and Fixtures [Member] | ||||
Property, Plant and Equipment, Useful Life (Year) | 7 years | |||
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | ||||
Number of Major Customers | 2 | 2 | 2 | |
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | Customer 1 [Member] | ||||
Concentration Risk, Percentage | 31.00% | 33.00% | 34.00% | |
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | Customer 2 [Member] | ||||
Concentration Risk, Percentage | 22.00% | 21.00% | 22.00% | |
Revision of Prior Period, Adjustment [Member] | ||||
Payments to Acquire Intangible Assets | $ 10,000 | |||
Previously Reported [Member] | ||||
Net Cash Provided by (Used in) Investing Activities, Total | $ (10,000) |
Note 2 - Significant Accounti_4
Note 2 - Significant Accounting Policies - Potentially Dilutive Securities Not Included in Calculation Of Diluted Net Loss Per Share (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Anti-dilutive securities not included in calculation of diluted net loss per share (in shares) | 8,110,814 | 8,979,797 | 9,149,700 |
Share-based Payment Arrangement, Option [Member] | |||
Anti-dilutive securities not included in calculation of diluted net loss per share (in shares) | 4,595,247 | 5,009,342 | 5,042,325 |
Warrant [Member] | |||
Anti-dilutive securities not included in calculation of diluted net loss per share (in shares) | 2,116,250 | 2,116,250 | 2,116,250 |
Unvested Restricted Stock Units [Member] | |||
Anti-dilutive securities not included in calculation of diluted net loss per share (in shares) | 1,399,317 | 1,854,205 | 1,991,125 |
Note 2 - Significant Accounti_5
Note 2 - Significant Accounting Policies - Assets Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Totals | $ 69,847 | $ 79,813 |
Commercial Paper [Member] | ||
Investments | 14,589 | |
Corporate Bond Securities [Member] | ||
Investments | 4,386 | 8,096 |
Fair Value, Inputs, Level 1 [Member] | ||
Totals | 50,872 | 59,919 |
Fair Value, Inputs, Level 1 [Member] | Commercial Paper [Member] | ||
Investments | 0 | |
Fair Value, Inputs, Level 1 [Member] | Corporate Bond Securities [Member] | ||
Investments | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Totals | 18,975 | 19,894 |
Fair Value, Inputs, Level 2 [Member] | Commercial Paper [Member] | ||
Investments | 14,589 | |
Fair Value, Inputs, Level 2 [Member] | Corporate Bond Securities [Member] | ||
Investments | 4,386 | 8,096 |
Fair Value, Inputs, Level 3 [Member] | ||
Totals | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | Commercial Paper [Member] | ||
Investments | 0 | |
Fair Value, Inputs, Level 3 [Member] | Corporate Bond Securities [Member] | ||
Investments | 0 | 0 |
Cash Equivalents [Member] | ||
Cash equivalents | 50,872 | 71,717 |
Cash Equivalents [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents | 50,872 | 59,919 |
Cash Equivalents [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash equivalents | 0 | 11,798 |
Cash Equivalents [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash equivalents | $ 0 | $ 0 |
Note 2 - Significant Accounti_6
Note 2 - Significant Accounting Policies - Summary of Cash Equivalents and Short-term Investment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Cash and cash equivalents | $ 63,131 | $ 85,293 |
Unrealized gains | 0 | 0 |
Unrealized losses | (2) | 0 |
Totals, amortized cost | 69,849 | 79,813 |
Totals, fair value | 69,847 | 79,813 |
Commercial Paper [Member] | ||
Investments, amortized cost | 14,590 | |
Unrealized gains | 0 | |
Unrealized losses | (1) | |
Investments, fair value | 14,589 | |
Corporate Bond Securities [Member] | ||
Investments, amortized cost | 4,387 | 8,096 |
Unrealized gains | 0 | |
Unrealized losses | (1) | 0 |
Investments, fair value | 4,386 | 8,096 |
Cash Equivalents [Member] | ||
Cash and cash equivalents | $ 50,872 | $ 71,717 |
Note 2 - Significant Accounti_7
Note 2 - Significant Accounting Policies - Inventory Balance (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Raw materials | $ 4,569 | $ 1,431 |
Work-in-process (materials, labor and overhead) | 1,385 | 1,258 |
Finished goods (materials, labor and overhead) | 1,155 | 765 |
Total Inventories | $ 7,109 | $ 3,454 |
Note 3 - Accounts Receivable,_3
Note 3 - Accounts Receivable, Net (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Accounts Receivable, Allowance for Credit Loss, Recovery | $ 1,000 | ||
Accounts Receivable, Credit Loss Expense (Reversal) | $ 0 | $ 1,000 | $ 0 |
Note 3 - Accounts Receivable,_4
Note 3 - Accounts Receivable, Net - Schedule of Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Trade accounts receivable | $ 29,646 | $ 21,515 |
License revenue receivable | 0 | 2,500 |
Royalty revenue receivable | 2,880 | 2,528 |
Total accounts receivable | 32,526 | 26,543 |
Allowance for credit losses | 0 | (1,000) |
Total accounts receivable, net | $ 32,526 | $ 25,543 |
Note 3 - Accounts Receivable,_5
Note 3 - Accounts Receivable, Net - Schedule of Allowance for Credit Losses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Balance | $ (1,000) | ||
Provision for credit loss expense | 0 | $ 1,000 | $ 0 |
Accounts receivable written-off | 0 | ||
Recoveries | 1,000 | ||
Balance | $ 0 | $ 1,000 |
Note 4 - Prepaid Expenses and_3
Note 4 - Prepaid Expenses and Other - Prepaid Expenses and Other (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
CRO services | $ 340 | $ 1,550 |
Other clinical development | 2,933 | 2,718 |
Insurance | 3,178 | 3,708 |
Professional fees | 398 | 651 |
Other | 2,135 | 2,635 |
Total, long-term | 8,984 | 11,262 |
CRO services | 166 | 518 |
Other clinical development | 577 | 437 |
Other | 611 | 790 |
Prepaid Expense and Other Assets, Noncurrent | 1,354 | 1,745 |
Totals | $ 10,338 | $ 13,007 |
Note 5 - Other Current Assets -
Note 5 - Other Current Assets - Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deposit for manufacturing costs | $ 0 | $ 3,376 |
Other | 447 | 265 |
Totals | $ 447 | $ 3,641 |
Note 6 - Property and Equipme_3
Note 6 - Property and Equipment (Details Textual) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Depreciation, Total | $ 0.7 | $ 0.9 | $ 0.9 |
Note 6 - Property and Equipme_4
Note 6 - Property and Equipment - Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment, Gross | $ 8,617 | $ 8,632 |
Less: accumulated depreciation | (6,861) | (6,151) |
Totals | 1,756 | 2,481 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment, Gross | 3,779 | 3,779 |
Computer Equipment [Member] | ||
Property, Plant and Equipment, Gross | 2,177 | 2,192 |
Telephone Equipment [Member] | ||
Property, Plant and Equipment, Gross | 302 | 302 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment, Gross | $ 2,359 | $ 2,359 |
Note 7 - Leases (Details Textua
Note 7 - Leases (Details Textual) $ in Millions | Dec. 31, 2011USD ($)ft² | Feb. 28, 2019ft² | Jun. 30, 2012USD ($)ft² | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Operating Lease, Expense | $ 5.1 | $ 5.1 | $ 5.1 | |||
Sublease Income | $ 0.5 | $ 0.4 | $ 0.2 | |||
CALIFORNIA | ||||||
Percentage of Annual Rent Increment | 3.00% | |||||
Area of Subleased Property (Square Foot) | ft² | 12,429 | |||||
Lease Agreement One [Member] | ||||||
Area of Leased Property (Square Foot) | ft² | 65,656 | |||||
Percentage of Annual Rent Increment | 3.00% | |||||
Letters of Credit Outstanding, Amount | $ 2 | |||||
Lease Agreement Two [Member] | ||||||
Area of Leased Property (Square Foot) | ft² | 29,470 | |||||
Percentage of Annual Rent Increment | 3.00% | |||||
Letters of Credit Outstanding, Amount | $ 1.1 | |||||
Lease Option To Extend Term (Year) | 5 years |
Note 7 - Leases - Future Minimu
Note 7 - Leases - Future Minimum Lease Payments Under ASC 842 (Details) $ in Thousands | Dec. 31, 2021USD ($) |
2022 | $ 5,483 |
2023 | 5,631 |
2024 | 5,805 |
2025 | 5,983 |
2026 | 1,508 |
Total minimum lease payments | 24,410 |
Less: imputed interest | (4,861) |
Total lease liabilities | $ 19,549 |
Note 7 - Leases - Future Mini_2
Note 7 - Leases - Future Minimum Lease Payments to be Receive (Details) $ in Thousands | Dec. 31, 2021USD ($) |
2022 | $ 481 |
2023 | 495 |
2024 | 510 |
2025 | 525 |
2026 | 133 |
Total | $ 2,144 |
Note 7 - Leases - Supplemental
Note 7 - Leases - Supplemental Cash Flow Information Related to Leases (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Operating cash flows used for operating leases (in thousands) | $ 5,731 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 0 |
Weighted average remaining lease term (in years) (Year) | 4 years 2 months 12 days |
Weighted average discount rate | 10.90% |
Note 8 - Intangible Assets - In
Note 8 - Intangible Assets - Intangible Assets, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Acquired and in-licensed rights | $ 90,000 | $ 90,000 |
Less: accumulated amortization | (23,875) | (15,860) |
Total intangible asset, net | $ 66,125 | $ 74,140 |
Note 8 - Intangible Assets - Fu
Note 8 - Intangible Assets - Future Amortization Expense Maturity (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Finite-Lived Intangible Asset, Expected Amortization, Year One | $ 8,015 |
Finite-Lived Intangible Asset, Expected Amortization, Year Two | 8,015 |
Finite-Lived Intangible Asset, Expected Amortization, Year Three | 8,015 |
Finite-Lived Intangible Asset, Expected Amortization, Year Four | 8,015 |
Finite-Lived Intangible Asset, Expected Amortization, Year Five | 8,015 |
Thereafter | 26,050 |
Totals | $ 66,125 |
Note 9 - Accrued Expenses (Deta
Note 9 - Accrued Expenses (Details Textual) - USD ($) $ in Thousands | Nov. 02, 2021 | Oct. 29, 2021 | Jan. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Legal Verdict Expense, Noncurrent | $ 0 | $ 24,822 | |||
Restructuring, Percentage of Reduction in Headcount | 13.00% | ||||
Employee Severance [Member] | |||||
Restructuring and Related Cost, Cost Incurred to Date | $ 1,200 | 100 | |||
Hsu v. Puma Biotechnology, Inc., [Member] | |||||
Litigation Settlement, Amount Awarded to Other Party | $ 54,200 | $ 54,200 | |||
Accrued Legal Verdict Expense, Noncurrent | $ 2,900 | ||||
Hsu v. Puma Biotechnology, Inc., [Member] | Subsequent Event [Member] | |||||
Litigation Settlement, Amount Awarded to Other Party | $ 54,200 | ||||
Payments for Legal Settlements | $ 27,200 |
Note 9 - Accrued Expenses - Com
Note 9 - Accrued Expenses - Composition of Current and Long-term Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued legal verdict expense | $ 57,137 | $ 22,724 |
Accrued royalties | 8,829 | 8,604 |
Accrued CRO services | 2,663 | 3,474 |
Accrued variable consideration | 11,406 | 9,014 |
Accrued bonus | 5,083 | 7,788 |
Accrued compensation | 3,878 | 4,820 |
Accrued other clinical development | 911 | 1,904 |
Accrued professional fees | 672 | 1,420 |
Accrued legal fees | 674 | 383 |
Accrued manufacturing costs | 690 | 752 |
Other | 632 | 442 |
Total, long-term | 92,575 | 61,325 |
Accrued Legal Verdict Expense, Noncurrent | 0 | 24,822 |
Accrued CRO services | 878 | 908 |
Accrued other | 37 | 233 |
Accrued Liabilities, Noncurrent | 915 | 25,963 |
Totals | $ 93,490 | $ 87,288 |
Note 10 - Debt (Details Textual
Note 10 - Debt (Details Textual) - USD ($) | Jul. 23, 2021 | Jun. 28, 2019 | May 31, 2018 | Dec. 31, 2018 | May 31, 2018 | Oct. 31, 2017 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Proceeds from Issuance of Debt | $ 98,500,000 | $ 8,444,000 | $ 25,000,000 | ||||||
Repayments of Debt | 100,000,000 | 8,444,000 | 80,000,000 | ||||||
Long-term Debt, Total | 102,000,000 | ||||||||
Amortization of Debt Issuance Costs | 2,600,000 | $ 2,000,000 | $ 1,500,000 | ||||||
Note Purchase Agreement [Member] | |||||||||
Debt Instrument, Face Amount | $ 100,000,000 | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | ||||||||
Debt Instrument, Interest Rate, Effective Percentage | 10.98% | ||||||||
Debt Instrument, Prepayment Fee Percentage | 2.00% | ||||||||
Debt Instrument, Unamortized Discount, Total | $ 1,500,000 | ||||||||
Debt Instrument, Periodic Payment, Exit Payment, Percent | 2.00% | ||||||||
Debt Instrument, Unused Borrowing Capacity, Amount | $ 25,000,000 | ||||||||
Debt Issuance Costs, Gross | $ 1,900,000 | ||||||||
Debt Instrument, Periodic Payment, Percent | 11.11% | ||||||||
Long-term Debt, Total | $ 100,000,000 | ||||||||
Note Purchase Agreement [Member] | London Interbank Offered Rate (LIBOR) [Member] | Minimum [Member] | |||||||||
Debt Instrument, Basis Spread on Variable Rate | 1.50% | ||||||||
Note Purchase Agreement [Member] | London Interbank Offered Rate (LIBOR) [Member] | Maximum [Member] | |||||||||
Debt Instrument, Basis Spread on Variable Rate | 3.50% | ||||||||
Oxford Finance Limited Liability Company [Member] | Secured Promissory Notes [Member] | |||||||||
Debt Instrument, Face Amount | $ 100,000,000 | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 9.00% | ||||||||
Debt Instrument, Basis Spread on Variable Rate | 3.50% | ||||||||
Debt instrument, Percentage of Original Principal Amount Payable in Final Payment | 7.50% | ||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 100,000,000 | ||||||||
Percentage of Issued and Outstanding Capital Stock of Subsidiary Pledged | 65.00% | ||||||||
Debt Instrument, Interest Rate, Effective Percentage | 12.75% | ||||||||
Debt Instrument, Debt Default, Additional Interest, Percent | 5.00% | ||||||||
Debt Instrument, Debt Default, Amount | $ 500,000 | ||||||||
Loss Contingency, Damages Sought, Value | $ 500,000 | ||||||||
Oxford Finance Limited Liability Company [Member] | Secured Promissory Notes [Member] | Debt Instrument, Redemption, Period One [Member] | |||||||||
Debt Instrument, Prepayment Fee Percentage | 3.00% | ||||||||
Oxford Finance Limited Liability Company [Member] | Secured Promissory Notes [Member] | Debt Instrument, Redemption, Period Two [Member] | |||||||||
Debt Instrument, Prepayment Fee Percentage | 2.00% | ||||||||
Oxford Finance Limited Liability Company [Member] | Secured Promissory Notes [Member] | Debt Instrument, Redemption, Period Three [Member] | |||||||||
Debt Instrument, Prepayment Fee Percentage | 1.00% | ||||||||
Silicon Valley Bank and Oxford Finance [Member] | |||||||||
Proceeds from Lines of Credit, Total | $ 50,000,000 | ||||||||
Debt Instrument, Face Amount | $ 155,000,000 | $ 155,000,000 | |||||||
Proceeds from Issuance of Debt | $ 30,000,000 | 125,000,000 | |||||||
Repayments of Debt | $ 155,000,000 | $ 50,000,000 | |||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.25% | 8.25% | |||||||
Debt Instrument, Basis Spread on Variable Rate | 3.50% | ||||||||
Debt instrument, Percentage of Original Principal Amount Payable in Final Payment | 7.50% | 7.50% |
Note 10 - Debt - Schedule of Lo
Note 10 - Debt - Schedule of Long Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Total debt, inclusive of $2.0 million exit payment | $ 102,000 | |
Less: deferred issuance costs and discounts | (4,908) | $ (5,002) |
Total long-term debt, net | $ 97,092 | $ 84,025 |
Note 10 - Debt - Schedule of _2
Note 10 - Debt - Schedule of Long Term Debt (Details) (Parentheticals) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Exit payment | $ 2 |
Note 10 - Debt - Future Minimum
Note 10 - Debt - Future Minimum Principal Payments (Details) $ in Thousands | Dec. 31, 2021USD ($) |
2022 | $ 0 |
2023 | 0 |
2024 | 33,997 |
2025 | 45,329 |
2026 | 22,674 |
Total | $ 102,000 |
Note 10 - Debt - Schedule of De
Note 10 - Debt - Schedule of Debt Issuance Costs and Discounts (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred issuance costs and discounts | $ 5,410 | $ 0 |
Debt issuance costs and discounts (Athyrium Notes) | 5,410 | 0 |
Less: accumulated amortization | (502) | (3,666) |
Included in long-term debt | 4,908 | 5,002 |
Note Purchase Agreement [Member] | ||
Deferred issuance costs and discounts | 0 | |
Debt issuance costs and discounts (Athyrium Notes) | $ 0 | |
Silicon Valley Bank and Oxford Finance [Member] | ||
Deferred issuance costs and discounts | 8,668 | |
Debt issuance costs and discounts (Athyrium Notes) | $ 8,668 |
Note 11 - Stockholders' Defic_3
Note 11 - Stockholders' Deficit (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Jul. 15, 2021 | Apr. 01, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 31, 2011 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) | 0 | 18,202 | 87,625 | |||
Common Stock, Shares Authorized (in shares) | 100,000,000 | 100,000,000 | ||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||
Ordinary Shares Ownership Percentage | 20.00% | |||||
Share-based Payment Arrangement, Expense | $ 32,633 | $ 36,575 | $ 57,327 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 7.90 | $ 7.81 | $ 12.08 | |||
Equity Incentive Plan Twenty Eleven [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 2,000,000 | |||||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 14,545,860 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance (in shares) | 5,068,592 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 4,159,934 | |||||
Employment Inducement Incentive Award Plan Twenty Seventeen [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 1,000,000 | |||||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 3,000,000 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance (in shares) | 925,972 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 1,454,340 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 3 years | |||||
Employment Inducement Incentive Award Plan Twenty Seventeen [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement By Share-based Payment Award, Options Initial Contractual Term (Year) | 10 years | |||||
Selling, General and Administrative Expenses [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 13,587 | $ 0 | $ 0 | |||
Common Stock [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,116,250 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 16 | |||||
Restricted Stock Units (RSUs) [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period (in shares) | 1,089,120 | 864,881 | 790,642 | |||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 11,000 | |||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 7 months 6 days | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 11.44 | $ 10.47 | $ 14.72 | |||
Restricted Stock Units (RSUs) [Member] | Selling, General and Administrative Expenses [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 8,239 | $ 13,841 | $ 18,848 | |||
Non-vested Stock Options [Member] | ||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 5,100 | |||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 9 months 18 days |
Note 11 - Stockholders' Defic_4
Note 11 - Stockholders' Deficit - Fair Value Options Weighted-Average Assumptions (Details) - Warrant To Acquire Common Stock [Member] | Dec. 31, 2021 |
Measurement Input, Expected Dividend Rate [Member] | |
Warrant measurement Input | 0 |
Measurement Input, Price Volatility [Member] | |
Warrant measurement Input | 0.870 |
Measurement Input, Risk Free Interest Rate [Member] | |
Warrant measurement Input | 0.008 |
Measurement Input, Expected Term [Member] | |
Warrant measurement Input | 5.31 |
Note 11 - Stockholders' Defic_5
Note 11 - Stockholders' Deficit - Options Award Assumptions (Details) - Employee and Nonemployee Stock Option [Member] | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Dividend yield | 0.00% | 0.00% |
Expected volatility | 86.60% | 100.60% |
Risk-free interest rate | 0.80% | 0.90% |
Expected life in years (Year) | 5 years 9 months 25 days | 5 years 9 months 21 days |
Note 11 - Stockholders' Defic_6
Note 11 - Stockholders' Deficit - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement, Expense | $ 32,633 | $ 36,575 | $ 57,327 |
Selling, General and Administrative Expenses [Member] | |||
Share-based Payment Arrangement, Expense | 13,587 | 0 | 0 |
Selling, General and Administrative Expenses [Member] | Share-based Payment Arrangement, Option [Member] | |||
Share-based Payment Arrangement, Expense | 3,873 | 3,937 | 9,044 |
Selling, General and Administrative Expenses [Member] | Restricted Stock Units (RSUs) [Member] | |||
Share-based Payment Arrangement, Expense | 8,239 | 13,841 | 18,848 |
Research and Development Expense [Member] | Share-based Payment Arrangement, Option [Member] | |||
Share-based Payment Arrangement, Expense | 573 | 3,018 | 7,452 |
Research and Development Expense [Member] | Restricted Stock Units (RSUs) [Member] | |||
Share-based Payment Arrangement, Expense | $ 6,361 | $ 15,779 | $ 21,983 |
Note 11 - Stockholders' Defic_7
Note 11 - Stockholders' Deficit - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Granted, shares (in shares) | 640,748 | 700,853 | |
Exercised, shares (in shares) | 0 | (18,202) | (87,625) |
Forfeited, shares (in shares) | (186,339) | ||
Nonvested, shares (in shares) | 835,297 | 899,672 | 439,194 |
The 2011 and 2017 Plans [Member] | |||
Balance, shares (in shares) | 5,009,342 | 5,042,325 | |
Balance, weighted average exercise price (in dollars per share) | $ 71.42 | $ 82.42 | |
Outstanding, weighted average remaining contractual term (Year) | 4 years 6 months | 5 years 1 month 6 days | 5 years 2 months 12 days |
Outstanding, aggregate intrinsic value | $ 0 | $ 3,458 | $ 1,951 |
Granted, shares (in shares) | 640,748 | 700,853 | |
Granted, weighted average exercise price (in dollars per share) | $ 11.12 | $ 10.03 | |
Granted, weighted average remaining contractual term (Year) | 8 years 2 months 12 days | 9 years 2 months 12 days | |
Exercised, shares (in shares) | (18,202) | ||
Exercised, weighted average exercise price (in dollars per share) | $ 3.75 | ||
Exercised, aggregate intrinsic value | $ 119 | ||
Expired, shares (in shares) | (868,504) | (715,634) | |
Expired, weighted average exercise price (in dollars per share) | $ 87.55 | $ 90.51 | |
Forfeited, shares (in shares) | (186,339) | ||
Forfeited, weighted average exercise price (in dollars per share) | $ 10.60 | ||
Balance, shares (in shares) | 4,595,247 | 5,009,342 | 5,042,325 |
Balance, weighted average exercise price (in dollars per share) | $ 62.43 | $ 71.42 | $ 82.42 |
Nonvested, shares (in shares) | 835,297 | ||
Nonvested, weighted average exercise price (in dollars per share) | $ 10.64 | ||
Nonvested, weighted average remaining contractual term (Year) | 8 years 10 months 24 days | ||
Nonvested, aggregate intrinsic value | $ 0 | ||
Exercisable, shares (in shares) | 3,759,950 | ||
Exercisable, weighted average exercise price (in dollars per share) | $ 73.93 | ||
Exercisable, weighted average remaining contractual term (Year) | 3 years 7 months 6 days | ||
Exercisable, aggregate intrinsic value | $ 0 |
Note 11 - Stockholders' Defic_8
Note 11 - Stockholders' Deficit - Stock Options Rollforward (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Nonvested shares (in shares) | 899,672 | 439,194 | |
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 8.71 | $ 19.38 | |
Granted, shares (in shares) | 640,748 | 700,853 | |
Granted, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 7.90 | $ 7.81 | $ 12.08 |
Vested/Issued, shares (in shares) | (518,784) | (240,375) | |
Vested/Issued, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 9.51 | $ 25.57 | |
Forfeited, shares (in shares) | (186,339) | ||
ForfeitedForfeited, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 7.96 | ||
Nonvested shares (in shares) | 835,297 | 899,672 | 439,194 |
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 7.76 | $ 8.71 | $ 19.38 |
Note 11 - Stockholders' Defic_9
Note 11 - Stockholders' Deficit - Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Nonvested shares (in shares) | 1,854,205 | 1,991,125 | |
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 13.51 | $ 27.63 | |
Granted shares (in shares) | 1,409,733 | 1,234,616 | |
Granted, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 11.44 | $ 10.47 | $ 14.72 |
Vested/Issued shares (in shares) | (1,089,120) | (864,881) | (790,642) |
Vested/Issued, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 14.99 | $ 36.86 | |
Forfeited shares (in shares) | (775,501) | (506,655) | |
Forfeited, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 12.13 | $ 21.72 | |
Nonvested shares (in shares) | 1,399,317 | 1,854,205 | 1,991,125 |
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 11.03 | $ 13.51 | $ 27.63 |
Note 12 - 401(k) Savings Plan (
Note 12 - 401(k) Savings Plan (Details Textual) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Defined Contribution Plan, Cost | $ 1.5 | $ 1.4 | $ 1.5 |
First 3% of Each Participant's Contributions [Member] | |||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 100.00% | ||
Second Two Percent Of Each Participants Contributions [Member] | |||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 50.00% |
Note 13 - Income Taxes (Details
Note 13 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Effective Income Tax Rate Reconciliation, Tax Expense (Benefit), Share-based Payment Arrangement, Amount | $ 22,500 | ||
Income Tax Benefit Due to Research and Development Tax Credits | 3,900 | ||
Unrecognized Tax Benefits, Increase Resulting from Current Period Tax Positions | 985 | $ 1,308 | $ 1,613 |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 12,500 | $ 8,700 | |
Domestic Tax Authority [Member] | |||
Operating Loss Carryforwards, Total | 950,200 | ||
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | |||
Tax Credit Carryforward, Amount | 39,700 | ||
State and Local Jurisdiction [Member] | |||
Operating Loss Carryforwards, Total | 871,000 | ||
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | |||
Tax Credit Carryforward, Amount | $ 24,100 |
Note 13 - Income Taxes - Schedu
Note 13 - Income Taxes - Schedule of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Federal | $ 0 | $ 0 | $ 0 |
State | 77 | 124 | 53 |
Foreign | 247 | 83 | 0 |
Current Income Tax Expense (Benefit), Total | 324 | 207 | 53 |
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Total provision | $ 324 | $ 207 | $ 53 |
Note 13 - Income Taxes - Sche_2
Note 13 - Income Taxes - Schedule of Income Tax Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Tax computed at the federal statutory rate | $ (6,045) | $ (12,540) | $ (15,830) |
State taxes | (1,072) | (2,304) | (2,453) |
Foreign taxes | 247 | 83 | 0 |
Permanent items | 22,689 | 13,660 | 21,834 |
R&D credits | (3,941) | (5,231) | (14,946) |
Prior year adjustment | 916 | (2,116) | (2,792) |
Change in valuation allowance | (12,470) | 8,655 | 14,240 |
Total provision | $ 324 | $ 207 | $ 53 |
Note 13 - Income Taxes - Compon
Note 13 - Income Taxes - Components of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | |||
Net operating loss carryforwards | $ 258,390 | $ 261,472 | $ 260,555 |
Business credit carryforwards | 59,514 | 55,574 | 50,343 |
Compensation | 40,647 | 58,112 | 60,967 |
Accrued legal verdict | 14,144 | 11,880 | 7,624 |
Carryforward of disallowed interest | 4,537 | 3,093 | 2,839 |
Accrued expenses | 104 | 561 | 9 |
Lease liabilities | 4,839 | 5,657 | 6,145 |
Other deferred tax assets | 1,306 | 804 | 13 |
Subtotal | 383,481 | 397,153 | 388,495 |
Deferred tax liabilities: | |||
Lease right-of-use assets | (3,470) | (4,099) | (4,505) |
Inventory | 406 | (21) | 0 |
Other deferred tax liabilities | (318) | (464) | (76) |
Subtotal | (3,382) | (4,584) | (4,581) |
Total deferred tax assets | 380,099 | 392,569 | 383,914 |
Valuation allowance | (380,099) | (392,569) | (383,914) |
Net deferred tax assets | $ 0 | $ 0 | $ 0 |
Note 13 - Income Taxes - Reconc
Note 13 - Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Unrecognized tax benefits - January 1 | $ 3,276 | $ 1,968 | $ 8,777 |
Gross decreases - tax positions in a prior period | 0 | 0 | (8,422) |
Gross increases - tax positions in a current period | 985 | 1,308 | 1,613 |
Unrecognized tax benefits - December 31 | $ 4,261 | $ 3,276 | $ 1,968 |
Note 14 - Commitments and Con_2
Note 14 - Commitments and Contingencies (Details Textual) $ / shares in Units, $ in Millions | Nov. 02, 2021USD ($) | Oct. 29, 2021USD ($) | Jun. 23, 2021USD ($) | Mar. 02, 2020USD ($) | Mar. 15, 2019USD ($) | Jan. 29, 2019$ / shares | Sep. 30, 2021USD ($) | Dec. 31, 2021USD ($) | Oct. 09, 2020USD ($) |
Milestone Payments Maximum Amount | $ 187.5 | ||||||||
Potential Milestone Payments | $ 90 | ||||||||
Percentage of Unpaid Portion of Milestone Payments Interest Rate | 6.25% | ||||||||
Milestone Payment | $ 1.8 | ||||||||
Hsu v. Puma Biotechnology, Inc., [Member] | |||||||||
Loss Contingency, Estimate of Possible Loss | $ 54.2 | ||||||||
Loss Contingency, Damages Awarded Per Share (in dollars per share) | $ / shares | $ 4.50 | ||||||||
Loss Contingency, Damages Awarded Percent of Total Claim | 5.00% | ||||||||
Loss Contingency, Claimed Damages Awarded Per Share (in dollars per share) | $ / shares | $ 87.20 | ||||||||
Loss Contingency, Claimed Damages, Amount | $ 50.5 | ||||||||
Litigation Settlement, Amount Awarded to Other Party | $ 54.2 | $ 54.2 | |||||||
Legal Settlements Payments, Number of Installments | 2 | ||||||||
Eshelman v. Puma Biotechnology, Inc. [Member] | |||||||||
Loss Contingency, Estimate of Possible Loss | 2.9 | ||||||||
Litigation Settlement, Amount Awarded to Other Party | $ 26.3 | ||||||||
Litigation Settlement, Expense | $ 3 | ||||||||
Loss Contingency Accrual, Period Increase (Decrease), Total | $ (22.4) | ||||||||
Letters of Credit Outstanding, Amount | 8.9 | ||||||||
Eshelman v. Puma Biotechnology, Inc. [Member] | Compensatory Damages [Member] | |||||||||
Loss Contingency, Damages Awarded, Value | $ 15.9 | ||||||||
Eshelman v. Puma Biotechnology, Inc. [Member] | Punitive Damages [Member] | |||||||||
Loss Contingency, Damages Awarded, Value | $ 6.5 | ||||||||
Clinical Trial Contracts [Member] | |||||||||
Potential Milestone Payments | 17.3 | ||||||||
Contractual Obligation, Total | $ 54.8 | ||||||||
Minimum [Member] | Clinical Trial Contracts [Member] | |||||||||
Termination Notice Period (Day) | 30 days | ||||||||
Maximum [Member] | Eshelman v. Puma Biotechnology, Inc. [Member] | |||||||||
Loss Contingency, Damages Sought, Value | $ 2.9 | ||||||||
Maximum [Member] | Clinical Trial Contracts [Member] | |||||||||
Termination Notice Period (Day) | 45 days |
Note 15 - Subsequent Events (De
Note 15 - Subsequent Events (Details Textual) - Hsu v. Puma Biotechnology, Inc., [Member] - USD ($) $ in Millions | Nov. 02, 2021 | Oct. 29, 2021 | Jan. 31, 2022 |
Litigation Settlement, Amount Awarded to Other Party | $ 54.2 | $ 54.2 | |
Subsequent Event [Member] | |||
Litigation Settlement, Amount Awarded to Other Party | $ 54.2 |