Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 01, 2023 | |
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 | Q1 | |
Document Fiscal Year Focus | 2022 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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 $0.0001 per share | |
Trading Symbol | PBYI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 46,707,012 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 61,394 | $ 76,201 |
Marketable securities | 9,823 | 4,873 |
Accounts receivable, net | 31,164 | 40,350 |
Inventory, net | 3,891 | 4,526 |
Prepaid expenses, current | 5,032 | 5,902 |
Other assets, current | 449 | 2,429 |
Total current assets | 111,753 | 134,281 |
Lease right-of-use assets, net | 10,650 | 11,362 |
Property and equipment, net | 1,019 | 1,146 |
Intangible assets, net | 68,175 | 70,610 |
Restricted cash, long-term | 2,591 | 2,591 |
Prepaid expenses and other, long-term | 2,069 | 2,069 |
Total assets | 196,257 | 222,059 |
Current liabilities: | ||
Accounts payable | 8,589 | 6,440 |
Accrued expenses, current | 34,135 | 53,034 |
Accrued in-licensed rights, current | 0 | 12,500 |
Post-marketing commitment liability, current | 1,167 | 1,370 |
Lease liabilities, current | 4,297 | 4,140 |
Total current liabilities | 48,188 | 77,484 |
Accrued expenses, long-term | 7,479 | 7,391 |
Lease liabilities, long-term | 10,715 | 11,834 |
Post-marketing commitment liability, long-term | 5,405 | 5,435 |
Total long-term debt, net | 98,623 | 98,307 |
Total liabilities | 170,410 | 200,451 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Common stock - $.0001 par value per share; 100,000,000 shares authorized; 46,663,599 shares issued and outstanding at March 31, 2023 and 46,345,660 issued and outstanding at December 31, 2022 | 5 | 5 |
Additional paid-in capital | 1,391,196 | 1,388,358 |
Accumulated deficit | (1,365,354) | (1,366,755) |
Total stockholders' equity | 25,847 | 21,608 |
Total liabilities and stockholders' equity | $ 196,257 | $ 222,059 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
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) | 46,663,599 | 46,345,660 |
Common stock, shares outstanding (in shares) | 46,663,599 | 46,345,660 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues: | ||
Total revenue | $ 52,775 | $ 45,736 |
Operating costs and expenses: | ||
Cost of sales | 13,218 | 10,844 |
Selling, general and administrative | 22,486 | 20,402 |
Research and development | 12,706 | 15,237 |
Total operating costs and expenses | 48,410 | 46,483 |
Income (loss) from operations | 4,365 | (747) |
Other income (expenses): | ||
Interest income | 537 | 13 |
Interest expense | (3,312) | (2,664) |
Legal verdict expense | 0 | (18) |
Other income (expense) | (42) | 50 |
Total other expenses | (2,817) | (2,619) |
Net income (loss) before income taxes | 1,548 | (3,366) |
Income tax expense | (147) | (37) |
Net income (loss) | $ 1,401 | $ (3,403) |
Net income (loss) per share of common stock—basic (in dollars per share) | $ 0.03 | $ (0.08) |
Net income (loss) per share of common stock—diluted (in dollars per share) | $ 0.03 | $ (0.08) |
Weighted-average shares of common stock outstanding—basic (in shares) | 46,636,083 | 42,207,709 |
Weighted-average shares of common stock outstanding—diluted (in shares) | 47,157,904 | 42,207,709 |
Product [Member] | ||
Revenues: | ||
Total revenue | $ 46,794 | $ 40,718 |
Royalty [Member] | ||
Revenues: | ||
Total revenue | $ 5,981 | $ 5,018 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net income (loss) | $ 1,401 | $ (3,403) |
Other comprehensive income: | ||
Unrealized gain on available-for-sale securities, net of tax of $0 and $0 | 0 | 1 |
Comprehensive income (loss) | $ 1,401 | $ (3,402) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) (Parentheticals) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Unrealized loss on available-for-sale securities, tax | $ 0 | $ 0 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - 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, 2021 | 41,175,507 | ||||
Balance at Dec. 31, 2021 | $ 4 | $ 1,364,309 | $ (2) | $ (1,366,757) | $ (2,446) |
Stock-based compensation | $ 0 | 3,148 | 0 | 0 | 3,148 |
Shares issued or restricted stock units vested under employee stock plans (in shares) | 189,625 | ||||
Shares issued or restricted stock units vested under employee stock plans | $ 0 | 0 | 0 | 0 | 0 |
Unrealized gain on available-for-sale securities, net of tax of $0 and $0 | 0 | 0 | 1 | 0 | 1 |
Net income (loss) | $ 0 | 0 | 0 | (3,403) | (3,403) |
Shares issued under private investments in public equity, net of issuance costs of approximately $0.2M (in shares) | 3,584,228 | ||||
Shares issued under private investments in public equity, net of issuance costs of approximately $0.2M | $ 0 | 9,845 | 0 | 0 | 9,845 |
Net Income (Loss) Attributable to Parent | $ 0 | 0 | 0 | (3,403) | (3,403) |
Balance (in shares) at Mar. 31, 2022 | 44,949,360 | ||||
Balance at Mar. 31, 2022 | $ 4 | 1,377,302 | (1) | (1,370,160) | $ 7,145 |
Balance (in shares) at Dec. 31, 2022 | 46,345,660 | 46,345,660 | |||
Balance at Dec. 31, 2022 | $ 5 | 1,388,358 | 0 | (1,366,755) | $ 21,608 |
Stock-based compensation | $ 0 | 2,838 | 0 | 0 | 2,838 |
Shares issued or restricted stock units vested under employee stock plans (in shares) | 317,939 | ||||
Shares issued or restricted stock units vested under employee stock plans | $ 0 | 0 | 0 | 0 | 0 |
Unrealized gain on available-for-sale securities, net of tax of $0 and $0 | 0 | 0 | 0 | 0 | 0 |
Net income (loss) | 0 | 0 | 0 | 1,401 | 1,401 |
Net Income (Loss) Attributable to Parent | $ 0 | 0 | 0 | 1,401 | $ 1,401 |
Balance (in shares) at Mar. 31, 2023 | 46,663,599 | 46,663,599 | |||
Balance at Mar. 31, 2023 | $ 5 | $ 1,391,196 | $ 0 | $ (1,365,354) | $ 25,847 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities: | ||
Net income (loss) | $ 1,401 | $ (3,403) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 2,878 | 2,457 |
Stock-based compensation | 2,838 | 3,148 |
Disposal of property and equipment | 0 | 1 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 9,186 | 5,487 |
Inventory, net | 635 | (168) |
Prepaid expenses and other | 870 | 903 |
Other current assets | 1,980 | (184) |
Accounts payable | 2,149 | (3,762) |
Operating lease assets and liabilities, net | (250) | (195) |
Accrued expenses and other | (18,811) | (30,897) |
Post-marketing commitment liability | (233) | (282) |
Net cash provided by (used in) operating activities | 2,643 | (26,895) |
Investing activities: | ||
Purchase of available-for-sale securities | (4,950) | 0 |
Maturity of available-for-sale securities | 0 | 8,982 |
Purchase of intangible assets | (12,500) | 0 |
Net cash provided by (used in) investing activities | (17,450) | 8,982 |
Financing activities: | ||
Gross proceeds from private investments in public equity | 0 | 10,000 |
Issuance costs associated with private investments in public equity | 0 | (155) |
Net cash provided by financing activities | 0 | 9,845 |
Net decrease in cash, cash equivalents and restricted cash | (14,807) | (8,068) |
Cash, cash equivalents and restricted cash, beginning of period | 78,792 | 75,292 |
Cash, cash equivalents and restricted cash, end of period | 63,985 | 67,224 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 2,907 | 2,375 |
Income taxes paid | $ 142 | $ 0 |
Note 1 - Business and Basis of
Note 1 - Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Business Description and Basis of Presentation [Text Block] | Note 1 Business and Basis of Presentation: Business: Puma Biotechnology, Inc., (the “Company”) is a biopharmaceutical company based in Los Angeles, California that develops and commercializes innovative products to enhance cancer care and improve treatment outcomes for patients. The Company is currently commercializing NERLYNX, an oral version of neratinib, for the treatment of HER2 The Company has one subsidiary, Puma Biotechnology, B.V., a Netherlands company. In March 2022, The Company has incurred significant operating losses since its inception. While the Company recently reported net income, we cannot assure that we will continue to do so and will need to continue to generate significant revenue to sustain operations and successfully commercialize neratinib. In 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. In September 2022, The Company has reported net income of approximately $1.4 million for the three March 31, 2023 may March 31, 2023 The Company believes that its existing cash and cash equivalents and marketable securities as of March 31, 2023 one 10 no may s, including the global COVID- 19 may Since its inception through March 31, 2023 the Company’s financing has primarily consisted of proceeds from product, royalty and license revenue, public offerings of its common stock, private equity placements, and various debt instruments. In the opinion of management, the included disclosures are adequate, and the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary for a fair statement of our consolidated financial position as of March 31, 2023. December 31, 2022 not March 31, 2023 not may December 31, 2023. |
Note 2 - Significant Accounting
Note 2 - Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 2 Significant Accounting Policies: The significant accounting policies followed in the preparation of these unaudited 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. Segment Reporting: Management has determined that the Company operates in one Use of Estimates: The preparation of consolidated financial statements in conformity with Generally Accepted Accounting Principles (“GAAP”) in the United States, 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. Reclassification Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no three March 31, 2022. Net Income (Loss) per Share of Common Stock: Basic net income (loss) per share of common stock is computed by dividing net loss available to common stockholders by the weighted-average number of shares of common stock outstanding during the periods presented, as required by Accounting Standards Codification (“ASC”), ASC 260, Earnings per Share not Our potentially dilutive securities include potential common shares related to our stock options and restricted stock units granted in connection with the Puma Biotechnology, Inc. 2011 2017 For the Three Months Ended March 31, 2023 2022 Options outstanding 4,658,944 4,528,668 Warrant outstanding 2,116,250 2,116,250 Unvested restricted stock units 487,305 2,081,989 Totals 7,262,499 8,726,907 The 2,116,250 shares underlying the warrant will not 10—Stockholders' A reconciliation of the numerators and denominators of the basic and diluted net loss per share of common stock computations is as follows (in thousands, except share and per share amounts): For the Three Months Ended March 31, 2023 2022 Numerator: Net income (loss) $ 1,401 $ (3,403 ) Denominator: Weighted average common stock outstanding for basic net income (loss) per share 46,636,083 42,207,709 Net effect of dilutive common stock equivalents 521,821 — Weighted average common stock outstanding for diluted net income (loss) per share 47,157,904 42,207,709 Net income (loss) per share of common stock Basic $ 0.03 $ (0.08 ) Diluted $ 0.03 $ (0.08 ) 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 Product revenue also consists of product sales under sub-license agreements to our sub-licensees, who then sell into their respective international territories. 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 three March 31, 2023 2022 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 Accounting Standards Update (“ASU”) ASU 2013 1, Balance Sheet (Topic 210 606 The amount of variable consideration that is included in the transaction price may not not March 31, 2023 not March 31, 2023 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 receivable, 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 the related revenue is recognized, resulting in a reduction of product revenue, net 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, net 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 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 As of March 31, 2023 ately $579.8 million. At Royalty Revenue: For sub-license agreements that are within the scope of ASC 606, 606 10 55 65. Royalty revenue consists of consideration earned related to international sales of NERLYNX made by the Company’s sub-licensees in their respective territories. The Company recognizes royalty revenue when the performance obligations have been satisfied. Royalty revenue was $6.0 million and $5.0 million for the three March 31, 2023 and 2022, Royalty Expenses: Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 12—Commitments Research and Development Expenses: Research and development expenses (“R&D expenses”) are charged to operations as incurred. The major components of R&D expenses 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 R&D expenses. Acquired In-Process Research and Development Expense: The Company has acquired, and may not no Stock-Based Compensation: Stock Option Awards ASC Topic 718, Compensation-Stock Compensation 718” 718, not 718, eight 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. 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 adjusted upon the actual forfeiture of an 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 10—Stockholders' 718, 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 March 31, 2023 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 12—Commitments 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 is pledged as collateral for stand-by letters of credit for lease commitments. The lease-related letters of credit will lapse at the end of the respective lease terms through 2 026. March 31, 2023 and December 31, 2022 , the Company had restricted cash in the amount of approximately $2.6 million . 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 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 market s for identical assets or 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 March 31, 2023 December 31, 2022 1 2 3 March 31, 2023 Level 1 Level 2 Level 3 Total Cash equivalents $ 37,242 $ — $ — $ 37,242 Commercial paper — 9,823 — 9,823 Totals $ 37,242 $ 9,823 $ — $ 47,065 December 31, 2022 Level 1 Level 2 Level 3 Total Cash equivalents $ 41,673 $ — $ — $ 41,673 Commercial paper — 4,873 — 4,873 Totals $ 41,673 $ 4,873 $ — $ 46,546 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 cash equivalents and short-term investments (in thousands): Maturity Amortized Unrealized Estimated March 31, 2023 (in years) cost Gains Losses fair value Cash equivalents $ 37,242 $ — $ — $ 37,242 Commercial paper Less than 1 9,823 — — 9,823 Totals $ 47,065 $ — $ — $ 47,065 Maturity Amortized Unrealized Estimated December 31, 2022 (in years) cost Gains Losses fair value Cash equivalents $ 41,673 $ — $ — $ 41,673 Commercial paper Less than 1 4,873 — — 4,873 Totals $ 46,546 $ — $ — $ 46,546 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 March 31, 2023 oximately million. 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 doubtful accounts primarily based on the credit worthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions. The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product and 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 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 R&D expenses 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. As of March 31, 2023 March 31, 2023 December 31, 2022 Raw materials $ 1,679 $ 1,679 Work-in-process (materials, labor and overhead) 1,362 2,661 Finished goods (materials, labor and overhead) 850 186 Total inventories $ 3,891 $ 4,526 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 estimated 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: Right-of-use assets (“ROU assets”) represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. ROU assets are evaluated for impairment using the long-lived assets impairment guidance, as required by ASC 360 . A significant indication of impairment of an ROU asset would include a change in the extent or manner in which the asset is being used. The Company must make assumptions which underlie the most significant and subjective estimates in determining whether any impairment exists. Those estimates, and the underlying assumptions, include estimates of future cash flow utilizing market lease rates and determination of fair value. If an ROU asset related to an operating lease is impaired, the carrying value of the ROU asset post-impairment should be amortized on a straight-line basis through the earlier of the end of the useful life of the ROU asset or the end of the lease term. Post impairment, a lessee must calculate the amortization of the ROU asset and interest expense on the lease liability separately, although the sum of the two no Leases will be 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 5—Leases. 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 March 31, 2023 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. In September 2022, not no 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, Pfizer (see Note 12—Commitments 2022, three March 31, 2023. 2030. approximately million and $2.0 million for the three March 31, 2023 and 2022, March 31, 2023 estimated future amortization expense related to the Company’s intangible assets was approximately million for the rema 2023 $9.7 2024 2029, mi 2030. Recen tly Issued Accounting Sta In November 2021, No. 2021 10, Government Assistance (Topic 832 2021 10” 2021 10 2021 10 December 15, 2021. 2022, March 31, 2023. |
Note 3 - Accounts Receivable, N
Note 3 - Accounts Receivable, Net | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Accounts Receivable [Text Block] | Note 3 Accounts Receivable, Net: Accounts receivable, net consisted of the following (in thousands): March 31, 2023 December 31, 2022 Trade accounts receivable $ 23,894 $ 27,600 Royalty revenue receivable 7,270 12,750 Total accounts receivable $ 31,164 $ 40,350 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 sub-licensees under sub-license agreements. 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 periods ended March 31, 2023 December 31, 2022 For all accounts receivable, the Company recognizes credit losses based on lifetime expected losses to selling, general and No March 31, 2023 December 31, 2022 |
Note 4 - Prepaid Expenses and O
Note 4 - Prepaid Expenses and Other | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Prepaid Expense and Other Assets [Text Block] | Note 4 Prepaid Expenses and Other: Prepaid expenses and other consisted of the following (in thousands): March 31, 2023 December 31, 2022 Current: CRO services $ 100 $ 431 Other clinical development 1,310 1,408 Insurance 1,714 2,318 Professional fees 404 300 Other 1,504 1,445 5,032 5,902 Long-term: Other clinical development 30 — Other 2,039 2,069 2,069 2,069 Totals $ 7,101 $ 7,971 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 - Leases
Note 5 - Leases | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | Note 5 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 Total rent expense for the three March 31, 2023 March 31, 2022 first may not Supplemental cash flow information related to leases for the three months ended March 31, 2023: Operating cash flows used for operating leases (in thousands) $ 1,498 Right-of-use assets obtained in exchange for new operating lease liabilities — Weighted average remaining lease term (in years) 3.0 Weighted average discount rate 10.9 % Future minimum lease payments as of March 31, 2023 Amount 2023 $ 4,254 2024 5,805 2025 5,983 2026 1,508 Total minimum lease payments $ 17,550 Less: imputed interest (2,538 ) Total lease liabilities $ 15,012 In February 2019, March 2026 g sublease income of million for both of the three March 31, 2023 and 2022 The future minimum lease payments to be received as of March 31, 2023 Amount 2023 $ 373 2024 510 2025 525 2026 134 Total $ 1,542 |
Note 6 - Property and Equipment
Note 6 - Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | Note 6 Property and Equipment, Net: Property and equipment, net consisted of the following (in thousands): March 31, 2023 December 31, 2022 Leasehold improvements $ 3,779 $ 3,779 Computer equipment 2,132 2,132 Telephone equipment 302 302 Furniture and fixtures 2,359 2,359 8,572 8,572 Less: accumulated depreciation (7,553 ) (7,426 ) Totals $ 1,019 $ 1,146 For the three March 31, 2023 2022, preciation expense of million and $0.2 million, resp |
Note 7 - Intangible Assets, Net
Note 7 - Intangible Assets, Net | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Intangible Assets Disclosure [Text Block] | Note 7 Intangible Assets, Net: Intangible assets, net consisted of the following (in thousands): March 31, 2023 December 31, 2022 Acquired and in-licensed rights $ 102,500 $ 102,500 Less: accumulated amortization (34,325 ) (31,890 ) Total intangible asset, net $ 68,175 $ 70,610 For the three March 31, 2023 March 31, 2023 7.0 |
Note 8 - Accrued Expenses
Note 8 - Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | Note 8 Accrued Expenses: Accrued expenses consisted of the following (in thousands): March 31, 2023 December 31, 2022 Current: Accrued legal verdict expense $ — $ 8,000 Accrued royalties 9,669 13,585 Accrued CRO services 1,364 1,796 Accrued variable consideration 12,630 12,304 Accrued bonus 1,711 7,667 Accrued compensation 4,387 4,301 Accrued other clinical development 815 1,233 Accrued professional fees 1,384 1,649 Accrued legal fees 1,601 1,731 Accrued manufacturing costs 170 553 Other 404 215 34,135 53,034 Long-term: Accrued legal verdict expense 7,442 7,354 Accrued other 37 37 7,479 7,391 Totals $ 41,614 $ 60,425 On October 29, 2021, Hsu v. Puma Biotechnology, Inc. et al. November 9, 2021, December 3, 2021. no two January 2022 June 2022. December 29, 2021, August 3, 2022, Also included in accrued legal verdict expense is approximately $7.4 million ($8.0 million net of imputed interest) as of March 31, 2023 Eshelman v. Puma Biotechnology, Inc., et al November 10, 2022, November 7, 2022, two first January 2023, November 1, 2024. 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 current accrued expenses consist primarily of marketing expenses, business license fees, and recruiting placement fees. |
Note 9 - Debt
Note 9 - Debt | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 9 Debt: Long term debt consisted of the following (in thousands): March 31, 2023 Maturity Date Total debt, inclusive of $2.0 million exit payment $ 102,000 July 23, 2026 Less: debt issuance costs and discounts (3,377 ) Total long-term debt, net $ 98,623 Athyrium Note Purchase Agreement: The Company issued senior notes for an aggregate principal amount of $100.0 million pursuant to a note purchase agreement dated July 23, 2021, July 23, 2026 ( 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, On September 16, 2022, third October 1, 2022. eight three three three 0.26161% three one one September 16, 2022, September 30, 2022, eight three not 470 50 Debt Modifications and Exchanges no not September 16, 2022 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. The Company is also required to maintain minimum cash balances and achieve certain minimum product revenue targets, measured as of the last day of each fiscal quarter on a trailing year-to-date basis. As of March 31, 2023 The future minimum principal and exit payments under the Athyrium Notes as of March 31, 2023 Amount 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): March 31, 2023 December 31, 2022 Debt issuance costs and discounts (Athyrium Notes) $ 5,410 $ 5,410 Less: accumulated amortization (2,033 ) (1,717 ) Included in long-term debt $ 3,377 $ 3,693 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 condensed consolidated statement of operations. For the three March 31, 2023 2022 imatel lion and $0.2 m |
Note 10 - Stockholders' Equity
Note 10 - Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | Note 10 Stockholders Equity: Common Stock: The Company issued no three March 31, 2023 2022 three March 31, 2023 2022 On March 8, 2022, 2 March 10, 2022. December 9, 2022 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, June 2021, may October 4, 2026. Stock Options and Restricted Stock Units: The Company’s 2011 September 15, 2011. 2011 may may 2011 2011 10 three 2011 March 31, 2023 2011 All of the options awarded by the Company have been “plain vanilla options” as determined by the SEC Staff Accounting Bulletin 107 Share Based Payment. As of March 31, 2023 , 6,235,783 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2011 shares of 2011 2—Significant three March 31 2023 2022 Dividend yield 0.0 % 0.0 % Expected volatility 85.5 % 86.2 % Risk-free interest rate 3.9 % 1.8 % Expected life in years 5.63 5.50 The Company’s 2017 any’s Board of Directors on April 27, 2017. 2017 may 2017 three 2017 July 15, 2021, 2017 March 31, 2023 a total of 3,000,000 shares of the Company’s common stock have been reserved for issuance under the 2017 March 31, 2023 , a total of 927,914 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2017 shares of the Company’s common stock are available for future issuance under the 2017 Stock-based compensation expense was as follows (in thousands): For the Three Months End March 31, 2023 2022 Stock-based compensation: Options: Selling, general, and administrative $ 758 $ 739 Research and development 152 137 Restricted stock units: Selling, general, and administrative 1,207 1,460 Research and development 721 812 Total stock-based compensation expense $ 2,838 $ 3,148 Activity with respect to options granted under the 2011 2017 Stock Option Rollforward: Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2022 4,212,481 $ 59.59 5.1 $ 1,046 Granted 581,614 $ 4.39 9.9 (Expired) (42,893 ) $ 116.94 Outstanding at March 31, 2023 4,751,202 $ 52.31 5.5 $ 383 Nonvested at March 31, 2023 1,141,605 $ 5.05 9.3 $ 199 Exercisable 3,609,597 $ 67.26 4.4 $ 183 At March 31, 2023 total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $3.5 million , which is expected to be recognized over a weighted-average period o f 1.4 years . At March 31, 2023 the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $8.5 million , which is expected to be recognized over a weighted-average period of 1.5 years . The weighted-average grant date fair value of options granted during the three March 31, 2023 2022 was $3.17 and $1.64 per share, respectively. The weighted average grant date fair value of RSUs awarded during the three March 31, 2023 2022 was $4.10 and $2.34 per share, respecti Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2022 799,376 $ 4.25 Granted 581,614 $ 3.17 (Vested) (239,385 ) $ 4.65 Nonvested shares at March 31, 2023 1,141,605 $ 3.62 Restricted Stock Unit Rollforward: Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2022 1,501,767 $ 4.92 Granted 1,264,527 $ 4.10 (Vested) (317,939 ) $ 4.94 (Forfeited) (35,860 ) $ 5.25 Nonvested shares at March 31, 2023 2,412,495 $ 4.48 |
Note 11 - 401(k) Savings Plan
Note 11 - 401(k) Savings Plan | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Compensation and Employee Benefit Plans [Text Block] | Note 11 401 During 2012, 401 401 first 3% 2% three March 31, 2023 2022 |
Note 12 - Commitments and Conti
Note 12 - Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | Note 12 Commitments and Contingencies: Contractual Obligations: Contractual obligations represent future cash commitments and liabilities under agreements with third may may not License Agreements: Pfizer License Agreement In August 2011, PB272 PB272 PB357, one December 31, 2011, fourth 2012. December 31, 2013. On July 18, 2014, 1 2 January 1, 2014 3 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. In connection with the FDA approval of NERLYNX in July 2017, one June 2020, one September 2021. 2022 , three March 31, 2023. 2030. 1 2 first third Takeda License Agreement In September 2022, October 2022 three September 30, 2022, March 31, 2023, no not 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 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, November 7, 2022. November 10, 2022, November 7, 2022, first January 2023, second November 1, 2024. Legal Malpractice Suit On September 17, 2020, November 23, 2020, August 19, 2022, 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 6, 2023. March 17, 2023, March 29, 2023. April 10, 2023, 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. 30 Effective December 13, 2022, No. 7,399,865 B2, December 8, 2030, The Company entered into the Settlement and License Agreement solely to eliminate the burden, expense, distraction and uncertainties of further litigation. Acebright China Litigation On January 18, 2022, 40mg three ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 4.2 not January 19, 2022. March 2, 2022, March 18, 2022. nine July 11, 2022, 5 6 No. ZL200880118789.3 not two not September 9, 2022, not 1, 3, 5 6 No. ZL201410082103.7 1 4, 7 9 13 No. ZL201080060546.6. three January 2023 three February 20, 2023. three three July 2022 Aosaikang ANDA China Litigation On November 17, 2022, No. CYHS2202006. 4.2 four ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 ZL201710057547.9, not ZL200880118789.3 ZL201710057547.9 not On December 28, 2022, four 76 four January 6, 2023, ZL201410082103.7 ZL201080060546.6. January 6, 2023, ZL200880118789.3 ZL201710057547.9, not not January 28, 2023, nine six four Convalife ANDA China Litigation Convalife Pharmaceuticals (Shanghai) Co., Ltd (“Convalife”) filed an ANDA with NMPA in China seeking approval to market a generic version of the Company’s NERLYNX®. The ANDA application No. CYHS2202095. December 23, 2022, 4.2 four ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 ZL201710057547.9, not ZL200880118789.3 ZL201710057547.9 not On February 1, 2023, four 76 four February 3, 2023, ZL201410082103.7 ZL201080060546.6. February 3, 2023, ZL200880118789.3 ZL201710057547.9, not not February 24, 2023, nine six four Kelun China Litigation Hunan Kelun Pharmaceutical Co., Ltd. (“Kelun”) filed an ANDA with NMPA in China seeking approval to market a generic version of the Company’s NERLYNX®. The ANDA application No. CYHS2300221. January 28, 2023, 4.2 four ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 ZL201710057547.9, not ZL200880118789.3 ZL201710057547.9 not On March 13, 2023, four 76 four March 21, 2023, ZL200880118789.3 ZL201710057547.9, not not March 24, 2023, ZL201410082103.7 ZL201080060546.6. six four |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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. |
Segment Reporting, Policy [Policy Text Block] | Segment Reporting: Management has determined that the Company operates in one |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates: The preparation of consolidated financial statements in conformity with Generally Accepted Accounting Principles (“GAAP”) in the United States, 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. |
Reclassification, Comparability Adjustment [Policy Text Block] | Reclassification Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no three March 31, 2022. |
Earnings Per Share, Policy [Policy Text Block] | Net Income (Loss) per Share of Common Stock: Basic net income (loss) per share of common stock is computed by dividing net loss available to common stockholders by the weighted-average number of shares of common stock outstanding during the periods presented, as required by Accounting Standards Codification (“ASC”), ASC 260, Earnings per Share not Our potentially dilutive securities include potential common shares related to our stock options and restricted stock units granted in connection with the Puma Biotechnology, Inc. 2011 2017 For the Three Months Ended March 31, 2023 2022 Options outstanding 4,658,944 4,528,668 Warrant outstanding 2,116,250 2,116,250 Unvested restricted stock units 487,305 2,081,989 Totals 7,262,499 8,726,907 The 2,116,250 shares underlying the warrant will not 10—Stockholders' A reconciliation of the numerators and denominators of the basic and diluted net loss per share of common stock computations is as follows (in thousands, except share and per share amounts): For the Three Months Ended March 31, 2023 2022 Numerator: Net income (loss) $ 1,401 $ (3,403 ) Denominator: Weighted average common stock outstanding for basic net income (loss) per share 46,636,083 42,207,709 Net effect of dilutive common stock equivalents 521,821 — Weighted average common stock outstanding for diluted net income (loss) per share 47,157,904 42,207,709 Net income (loss) per share of common stock Basic $ 0.03 $ (0.08 ) Diluted $ 0.03 $ (0.08 ) |
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 Product revenue also consists of product sales under sub-license agreements to our sub-licensees, who then sell into their respective international territories. 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 three March 31, 2023 2022 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 Accounting Standards Update (“ASU”) ASU 2013 1, Balance Sheet (Topic 210 606 The amount of variable consideration that is included in the transaction price may not not March 31, 2023 not March 31, 2023 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 receivable, 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 the related revenue is recognized, resulting in a reduction of product revenue, net 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, net 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 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 As of March 31, 2023 ately $579.8 million. At Royalty Revenue: For sub-license agreements that are within the scope of ASC 606, 606 10 55 65. Royalty revenue consists of consideration earned related to international sales of NERLYNX made by the Company’s sub-licensees in their respective territories. The Company recognizes royalty revenue when the performance obligations have been satisfied. Royalty revenue was $6.0 million and $5.0 million for the three March 31, 2023 and 2022, |
Royalties, Policy [Policy Text Block] | Royalty Expenses: Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 12—Commitments |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses: Research and development expenses (“R&D expenses”) are charged to operations as incurred. The major components of R&D expenses 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 R&D expenses. |
In Process Research and Development, Policy [Policy Text Block] | Acquired In-Process Research and Development Expense: The Company has acquired, and may not no |
Share-Based Payment Arrangement [Policy Text Block] | Stock-Based Compensation: Stock Option Awards ASC Topic 718, Compensation-Stock Compensation 718” 718, not 718, eight 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. 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 adjusted upon the actual forfeiture of an 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 10—Stockholders' 718, |
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 March 31, 2023 |
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 12—Commitments |
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 is pledged as collateral for stand-by letters of credit for lease commitments. The lease-related letters of credit will lapse at the end of the respective lease terms through 2 026. March 31, 2023 and December 31, 2022 , the Company had restricted cash in the amount of approximately $2.6 million . |
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 |
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 market s for identical assets or 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 March 31, 2023 December 31, 2022 1 2 3 March 31, 2023 Level 1 Level 2 Level 3 Total Cash equivalents $ 37,242 $ — $ — $ 37,242 Commercial paper — 9,823 — 9,823 Totals $ 37,242 $ 9,823 $ — $ 47,065 December 31, 2022 Level 1 Level 2 Level 3 Total Cash equivalents $ 41,673 $ — $ — $ 41,673 Commercial paper — 4,873 — 4,873 Totals $ 41,673 $ 4,873 $ — $ 46,546 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 cash equivalents and short-term investments (in thousands): Maturity Amortized Unrealized Estimated March 31, 2023 (in years) cost Gains Losses fair value Cash equivalents $ 37,242 $ — $ — $ 37,242 Commercial paper Less than 1 9,823 — — 9,823 Totals $ 47,065 $ — $ — $ 47,065 Maturity Amortized Unrealized Estimated December 31, 2022 (in years) cost Gains Losses fair value Cash equivalents $ 41,673 $ — $ — $ 41,673 Commercial paper Less than 1 4,873 — — 4,873 Totals $ 46,546 $ — $ — $ 46,546 |
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 March 31, 2023 oximately million. 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 doubtful accounts primarily based on the credit worthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions. The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product and 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 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 R&D expenses 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. As of March 31, 2023 March 31, 2023 December 31, 2022 Raw materials $ 1,679 $ 1,679 Work-in-process (materials, labor and overhead) 1,362 2,661 Finished goods (materials, labor and overhead) 850 186 Total inventories $ 3,891 $ 4,526 |
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 estimated 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: Right-of-use assets (“ROU assets”) represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. ROU assets are evaluated for impairment using the long-lived assets impairment guidance, as required by ASC 360 . A significant indication of impairment of an ROU asset would include a change in the extent or manner in which the asset is being used. The Company must make assumptions which underlie the most significant and subjective estimates in determining whether any impairment exists. Those estimates, and the underlying assumptions, include estimates of future cash flow utilizing market lease rates and determination of fair value. If an ROU asset related to an operating lease is impaired, the carrying value of the ROU asset post-impairment should be amortized on a straight-line basis through the earlier of the end of the useful life of the ROU asset or the end of the lease term. Post impairment, a lessee must calculate the amortization of the ROU asset and interest expense on the lease liability separately, although the sum of the two no Leases will be 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 5—Leases. 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 March 31, 2023 |
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. In September 2022, not no 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, Pfizer (see Note 12—Commitments 2022, three March 31, 2023. 2030. approximately million and $2.0 million for the three March 31, 2023 and 2022, March 31, 2023 estimated future amortization expense related to the Company’s intangible assets was approximately million for the rema 2023 $9.7 2024 2029, mi 2030. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recen tly Issued Accounting Sta In November 2021, No. 2021 10, Government Assistance (Topic 832 2021 10” 2021 10 2021 10 December 15, 2021. 2022, March 31, 2023. |
Note 2 - Significant Accounti_2
Note 2 - Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | For the Three Months Ended March 31, 2023 2022 Options outstanding 4,658,944 4,528,668 Warrant outstanding 2,116,250 2,116,250 Unvested restricted stock units 487,305 2,081,989 Totals 7,262,499 8,726,907 |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | For the Three Months Ended March 31, 2023 2022 Numerator: Net income (loss) $ 1,401 $ (3,403 ) Denominator: Weighted average common stock outstanding for basic net income (loss) per share 46,636,083 42,207,709 Net effect of dilutive common stock equivalents 521,821 — Weighted average common stock outstanding for diluted net income (loss) per share 47,157,904 42,207,709 Net income (loss) per share of common stock Basic $ 0.03 $ (0.08 ) Diluted $ 0.03 $ (0.08 ) |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | March 31, 2023 Level 1 Level 2 Level 3 Total Cash equivalents $ 37,242 $ — $ — $ 37,242 Commercial paper — 9,823 — 9,823 Totals $ 37,242 $ 9,823 $ — $ 47,065 December 31, 2022 Level 1 Level 2 Level 3 Total Cash equivalents $ 41,673 $ — $ — $ 41,673 Commercial paper — 4,873 — 4,873 Totals $ 41,673 $ 4,873 $ — $ 46,546 |
Cash, Cash Equivalents and Investments [Table Text Block] | Maturity Amortized Unrealized Estimated March 31, 2023 (in years) cost Gains Losses fair value Cash equivalents $ 37,242 $ — $ — $ 37,242 Commercial paper Less than 1 9,823 — — 9,823 Totals $ 47,065 $ — $ — $ 47,065 Maturity Amortized Unrealized Estimated December 31, 2022 (in years) cost Gains Losses fair value Cash equivalents $ 41,673 $ — $ — $ 41,673 Commercial paper Less than 1 4,873 — — 4,873 Totals $ 46,546 $ — $ — $ 46,546 |
Schedule of Inventory, Current [Table Text Block] | March 31, 2023 December 31, 2022 Raw materials $ 1,679 $ 1,679 Work-in-process (materials, labor and overhead) 1,362 2,661 Finished goods (materials, labor and overhead) 850 186 Total inventories $ 3,891 $ 4,526 |
Note 3 - Accounts Receivable,_2
Note 3 - Accounts Receivable, Net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Schedule of Accounts Receivable [Table Text Block] | March 31, 2023 December 31, 2022 Trade accounts receivable $ 23,894 $ 27,600 Royalty revenue receivable 7,270 12,750 Total accounts receivable $ 31,164 $ 40,350 |
Note 4 - Prepaid Expenses and_2
Note 4 - Prepaid Expenses and Other (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Prepaid Expense and Other Assets [TableText Block] | March 31, 2023 December 31, 2022 Current: CRO services $ 100 $ 431 Other clinical development 1,310 1,408 Insurance 1,714 2,318 Professional fees 404 300 Other 1,504 1,445 5,032 5,902 Long-term: Other clinical development 30 — Other 2,039 2,069 2,069 2,069 Totals $ 7,101 $ 7,971 |
Note 5 - Leases (Tables)
Note 5 - Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Lessee, Operating Leases Related To Supplemental Cash Flow Information [Table Text Block] | Supplemental cash flow information related to leases for the three months ended March 31, 2023: Operating cash flows used for operating leases (in thousands) $ 1,498 Right-of-use assets obtained in exchange for new operating lease liabilities — Weighted average remaining lease term (in years) 3.0 Weighted average discount rate 10.9 % |
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block] | Amount 2023 $ 4,254 2024 5,805 2025 5,983 2026 1,508 Total minimum lease payments $ 17,550 Less: imputed interest (2,538 ) Total lease liabilities $ 15,012 |
Lessor, Operating Lease, Payment to be Received, Maturity [Table Text Block] | Amount 2023 $ 373 2024 510 2025 525 2026 134 Total $ 1,542 |
Note 6 - Property and Equipme_2
Note 6 - Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | March 31, 2023 December 31, 2022 Leasehold improvements $ 3,779 $ 3,779 Computer equipment 2,132 2,132 Telephone equipment 302 302 Furniture and fixtures 2,359 2,359 8,572 8,572 Less: accumulated depreciation (7,553 ) (7,426 ) Totals $ 1,019 $ 1,146 |
Note 7 - Intangible Assets, N_2
Note 7 - Intangible Assets, Net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Schedule of Finite-Lived Intangible Assets [Table Text Block] | March 31, 2023 December 31, 2022 Acquired and in-licensed rights $ 102,500 $ 102,500 Less: accumulated amortization (34,325 ) (31,890 ) Total intangible asset, net $ 68,175 $ 70,610 |
Note 8 - Accrued Expenses (Tabl
Note 8 - Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | March 31, 2023 December 31, 2022 Current: Accrued legal verdict expense $ — $ 8,000 Accrued royalties 9,669 13,585 Accrued CRO services 1,364 1,796 Accrued variable consideration 12,630 12,304 Accrued bonus 1,711 7,667 Accrued compensation 4,387 4,301 Accrued other clinical development 815 1,233 Accrued professional fees 1,384 1,649 Accrued legal fees 1,601 1,731 Accrued manufacturing costs 170 553 Other 404 215 34,135 53,034 Long-term: Accrued legal verdict expense 7,442 7,354 Accrued other 37 37 7,479 7,391 Totals $ 41,614 $ 60,425 |
Note 9 - Debt (Tables)
Note 9 - Debt (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Schedule of Debt [Table Text Block] | March 31, 2023 Maturity Date Total debt, inclusive of $2.0 million exit payment $ 102,000 July 23, 2026 Less: debt issuance costs and discounts (3,377 ) Total long-term debt, net $ 98,623 |
Schedule of Maturities of Long-Term Debt [Table Text Block] | Amount 2024 $ 33,997 2025 45,329 2026 22,674 Total $ 102,000 |
Schedule of Deferred Financing Costs [Table Text Block] | March 31, 2023 December 31, 2022 Debt issuance costs and discounts (Athyrium Notes) $ 5,410 $ 5,410 Less: accumulated amortization (2,033 ) (1,717 ) Included in long-term debt $ 3,377 $ 3,693 |
Note 10 - Stockholders' Equity
Note 10 - Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | For the Three Months End March 31, 2023 2022 Stock-based compensation: Options: Selling, general, and administrative $ 758 $ 739 Research and development 152 137 Restricted stock units: Selling, general, and administrative 1,207 1,460 Research and development 721 812 Total stock-based compensation expense $ 2,838 $ 3,148 |
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, 2022 4,212,481 $ 59.59 5.1 $ 1,046 Granted 581,614 $ 4.39 9.9 (Expired) (42,893 ) $ 116.94 Outstanding at March 31, 2023 4,751,202 $ 52.31 5.5 $ 383 Nonvested at March 31, 2023 1,141,605 $ 5.05 9.3 $ 199 Exercisable 3,609,597 $ 67.26 4.4 $ 183 |
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, 2022 799,376 $ 4.25 Granted 581,614 $ 3.17 (Vested) (239,385 ) $ 4.65 Nonvested shares at March 31, 2023 1,141,605 $ 3.62 |
Share-Based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block] | Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2022 1,501,767 $ 4.92 Granted 1,264,527 $ 4.10 (Vested) (317,939 ) $ 4.94 (Forfeited) (35,860 ) $ 5.25 Nonvested shares at March 31, 2023 2,412,495 $ 4.48 |
Warrant [Member] | |
Notes Tables | |
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block] | 2023 2022 Dividend yield 0.0 % 0.0 % Expected volatility 85.5 % 86.2 % Risk-free interest rate 3.9 % 1.8 % Expected life in years 5.63 5.50 |
Note 1 - Business and Basis o_2
Note 1 - Business and Basis of Presentation (Details Textual) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 | |
Number of Subsidiaries | 1 | 2 | |
Net Income (Loss) Attributable to Parent | $ 1,401 | $ (3,403) | |
Net Cash Provided by (Used in) Operating Activities | 2,643 | $ (26,895) | |
Cash, Cash Equivalents, and Marketable Securities | $ 71,200 |
Note 2 - Significant Accounti_3
Note 2 - Significant Accounting Policies (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Oct. 31, 2012 | |
Sublease Agreement, Potential Milestone Payments | $ 579,800 | ||||
Revenue from Contract with Customer, Excluding Assessed Tax | 52,775 | $ 45,736 | |||
Restricted Cash, Total | 2,600 | ||||
Cash and Cash Equivalents, and Restricted Cash In Excess of Insured Limits | $ 62,800 | ||||
Average Incremental Borrowing Rate | 10.90% | ||||
Operating Lease, Impairment Loss | $ 0 | ||||
Amortization of Intangible Assets | 2,400 | 2,000 | |||
Finite-Lived Intangible Asset, Expected Amortization, Remainder of Fiscal Year | 7,300 | ||||
Finite-Lived Intangible Asset, Expected Amortization, Year One | 9,700 | ||||
Finite-Lived Intangible Asset, Expected Amortization, Year Two | 9,700 | ||||
Finite-Lived Intangible Asset, Expected Amortization, Year Three | 9,700 | ||||
Finite-Lived Intangible Asset, Expected Amortization, Year Four | 9,700 | ||||
Finite-Lived Intangible Asset, Expected Amortization, Year Five | 9,700 | ||||
Finite-Lived Intangible Asset, Expected Amortization, Year Six | 9,700 | ||||
Finite-Lived Intangible Asset, Expected Amortization, Year Seven | $ 2,400 | ||||
Payroll Tax Credit | 3,800 | 3,800 | |||
Pfizer License Agreement [Member] | |||||
Potential Milestone Payments | $ 12,500 | ||||
Takeda License Agreement [Member] | |||||
Research and Development Expense | $ 7,000 | ||||
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 | ||||
Royalty [Member] | |||||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 5,981 | $ 5,018 | |||
NERLYNX [Member] | |||||
Revenue from Contract with Customer, Including Assessed Tax | $ 250,000 | $ 250,000 | |||
Common Stock [Member] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,116,250 | 2,116,250 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 16 | $ 16 |
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 | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Anti-dilutive securities not included in calculation of diluted net loss per share (in shares) | 7,262,499 | 8,726,907 |
Employee and Nonemployee Stock Option [Member] | ||
Anti-dilutive securities not included in calculation of diluted net loss per share (in shares) | 4,658,944 | 4,528,668 |
Warrant [Member] | ||
Anti-dilutive securities not included in calculation of diluted net loss per share (in shares) | 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) | 487,305 | 2,081,989 |
Note 2 - Significant Accounti_5
Note 2 - Significant Accounting Policies - Summary of Reconciliation of Numerators and Denominators of Basic and Diluted Net Income (Loss) Per Share of Common Stock Computations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net income (loss) | $ 1,401 | $ (3,403) |
Weighted average common stock outstanding for basic net income (loss) per share (in shares) | 46,636,083 | 42,207,709 |
Net effect of dilutive common stock equivalents (in shares) | 521,821 | 0 |
Weighted average common stock outstanding for diluted net income (loss) per share (in shares) | 47,157,904 | 42,207,709 |
Basic (in dollars per share) | $ 0.03 | $ (0.08) |
Diluted (in dollars per share) | $ 0.03 | $ (0.08) |
Note 2 - Significant Accounti_6
Note 2 - Significant Accounting Policies - Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Recurring [Member] | ||
Totals | $ 47,065 | $ 46,546 |
Totals | 47,065 | 46,546 |
Fair Value, Recurring [Member] | Commercial Paper [Member] | ||
Investments | 9,823 | 4,873 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Totals | 37,242 | 41,673 |
Totals | 37,242 | 41,673 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Commercial Paper [Member] | ||
Investments | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Totals | 9,823 | 4,873 |
Totals | 9,823 | 4,873 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Commercial Paper [Member] | ||
Investments | 9,823 | 4,873 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Totals | 0 | 0 |
Totals | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Commercial Paper [Member] | ||
Investments | 0 | 0 |
Cash Equivalents [Member] | ||
Cash equivalents | 37,242 | 41,673 |
Cash Equivalents [Member] | Fair Value, Recurring [Member] | ||
Cash equivalents | 37,242 | 41,673 |
Cash Equivalents [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents | 37,242 | 41,673 |
Cash Equivalents [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash equivalents | 0 | 0 |
Cash Equivalents [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash equivalents | $ 0 | $ 0 |
Note 2 - Significant Accounti_7
Note 2 - Significant Accounting Policies - Summary of Cash Equivalents and Short-term Investment (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Cash and cash equivalents | $ 61,394 | $ 76,201 |
Unrealized gains | 0 | 0 |
Unrealized losses | 0 | 0 |
Totals, amortized cost | 47,065 | 46,546 |
Totals, fair value | 47,065 | 46,546 |
Commercial Paper [Member] | ||
Investments, amortized cost | 9,823 | 4,873 |
Unrealized gains | 0 | 0 |
Unrealized losses | 0 | 0 |
Investments, fair value | 9,823 | 4,873 |
Cash Equivalents [Member] | ||
Cash and cash equivalents | 37,242 | 41,673 |
Cash equivalents | $ 37,242 | $ 41,673 |
Note 2 - Significant Accounti_8
Note 2 - Significant Accounting Policies - Inventory Balance (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Raw materials | $ 1,679 | $ 1,679 |
Work-in-process (materials, labor and overhead) | 1,362 | 2,661 |
Finished goods (materials, labor and overhead) | 850 | 186 |
Total inventories | $ 3,891 | $ 4,526 |
Note 3 - Accounts Receivable,_3
Note 3 - Accounts Receivable, Net (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Accounts Receivable, Credit Loss Expense (Reversal) | $ 0 | $ 0 |
Note 3 - Accounts Receivable,_4
Note 3 - Accounts Receivable, Net - Schedule of Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Trade accounts receivable | $ 23,894 | $ 27,600 |
Royalty revenue receivable | 7,270 | 12,750 |
Total accounts receivable | $ 31,164 | $ 40,350 |
Note 4 - Prepaid Expenses and_3
Note 4 - Prepaid Expenses and Other - Prepaid Expenses and Other (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
CRO services | $ 100 | $ 431 |
Other clinical development | 1,310 | 1,408 |
Insurance | 1,714 | 2,318 |
Professional fees | 404 | 300 |
Other | 1,504 | 1,445 |
Total, long-term | 5,032 | 5,902 |
Other clinical development | 30 | 0 |
Other | 2,039 | 2,069 |
Prepaid Expense and Other Assets, Noncurrent | 2,069 | 2,069 |
Totals | $ 7,101 | $ 7,971 |
Note 5 - Leases (Details Textua
Note 5 - Leases (Details Textual) $ in Millions | 1 Months Ended | 3 Months Ended | |||
Dec. 31, 2011 USD ($) ft² | Feb. 28, 2019 ft² | Jun. 30, 2012 USD ($) ft² | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | |
Operating Lease, Expense | $ | $ 1.2 | $ 1.3 | |||
Sublease Income | $ | $ 0.1 | $ 0.1 | |||
CALIFORNIA | |||||
Percentage of Annual Rent Increment | 3% | ||||
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% | ||||
Lease Agreement Two [Member] | |||||
Area of Leased Property (Square Foot) | ft² | 29,470 | ||||
Percentage of Annual Rent Increment | 3% | ||||
Letters of Credit Outstanding, Amount | $ | $ 1.5 | $ 1.1 | |||
Lease Option To Extend Term (Year) | 5 years |
Note 5 - Leases - Supplemental
Note 5 - Leases - Supplemental Cash Flow Information Related to Leases (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Operating cash flows used for operating leases (in thousands) | $ 1,498 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 0 |
Weighted average remaining lease term (in years) (Year) | 3 years |
Weighted average discount rate | 10.90% |
Note 5 - Leases - Future Minimu
Note 5 - Leases - Future Minimum Lease Payments Under ASC 842 (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
2023 | $ 4,254 |
2024 | 5,805 |
2025 | 5,983 |
2026 | 1,508 |
Total minimum lease payments | 17,550 |
Less: imputed interest | (2,538) |
Total lease liabilities | $ 15,012 |
Note 5 - Leases - Future Mini_2
Note 5 - Leases - Future Minimum Lease Payments to be Received (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
2023 | $ 373 |
2024 | 510 |
2025 | 525 |
2026 | 134 |
Total | $ 1,542 |
Note 6 - Property and Equipme_3
Note 6 - Property and Equipment, Net (Details Textual) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Depreciation | $ 0.1 | $ 0.2 |
Note 6 - Property and Equipme_4
Note 6 - Property and Equipment - Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment, Gross | $ 8,572 | $ 8,572 |
Less: accumulated depreciation | (7,553) | (7,426) |
Totals | 1,019 | 1,146 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment, Gross | 3,779 | 3,779 |
Computer Equipment [Member] | ||
Property, Plant and Equipment, Gross | 2,132 | 2,132 |
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 - Intangible Assets, N_3
Note 7 - Intangible Assets, Net (Details Textual) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Amortization of Intangible Assets | $ 2.4 | $ 2 |
Finite-Lived Intangible Asset, Useful Life (Year) | 7 years |
Note 7 - Intangible Assets - In
Note 7 - Intangible Assets - Intangible Assets, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Acquired and in-licensed rights | $ 102,500 | $ 102,500 |
Less: accumulated amortization | (34,325) | (31,890) |
Total intangible asset, net | $ 68,175 | $ 70,610 |
Note 8 - Accrued Expenses (Deta
Note 8 - Accrued Expenses (Details Textual) $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||||
Nov. 01, 2024 USD ($) | Nov. 07, 2022 USD ($) | Nov. 09, 2021 USD ($) | Mar. 02, 2020 USD ($) | Jan. 31, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jan. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 | |
Interest Expense | $ 3,312 | $ 2,664 | ||||||||
Hsu v. Puma Biotechnology, Inc., [Member] | ||||||||||
Litigation Settlement, Amount Awarded to Other Party | $ 0 | |||||||||
Payments for Legal Settlements | $ 27,100 | $ 27,100 | 7,400 | |||||||
Interest Expense | $ 8,000 | |||||||||
Eshelman v. Puma Biotechnology, Inc. [Member] | ||||||||||
Litigation Settlement, Amount Awarded to Other Party | $ 16,000 | $ 26,300 | ||||||||
Payments for Legal Settlements | $ 8,000 | |||||||||
Legal Settlements Payments, Number of Installments | 2 | 2 | ||||||||
Eshelman v. Puma Biotechnology, Inc. [Member] | Forecast [Member] | ||||||||||
Payments for Legal Settlements | $ 8,000 |
Note 8 - Accrued Expenses - Com
Note 8 - Accrued Expenses - Composition of Current and Long-term Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued legal verdict expense | $ 0 | $ 8,000 |
Accrued royalties | 9,669 | 13,585 |
Accrued CRO services | 1,364 | 1,796 |
Accrued variable consideration | 12,630 | 12,304 |
Accrued bonus | 1,711 | 7,667 |
Accrued compensation | 4,387 | 4,301 |
Accrued other clinical development | 815 | 1,233 |
Accrued professional fees | 1,384 | 1,649 |
Accrued legal fees | 1,601 | 1,731 |
Accrued manufacturing costs | 170 | 553 |
Other | 404 | 215 |
Total, long-term | 34,135 | 53,034 |
Accrued legal verdict expense | 7,442 | 7,354 |
Accrued other | 37 | 37 |
Accrued Liabilities, Noncurrent | 7,479 | 7,391 |
Totals | $ 41,614 | $ 60,425 |
Note 9 - Debt (Details Textual)
Note 9 - Debt (Details Textual) - USD ($) $ in Millions | 3 Months Ended | ||||
Sep. 16, 2022 | Jul. 23, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Jun. 28, 2019 | |
Long-term Debt, Total | $ 102 | ||||
Amortization of Debt Issuance Costs | $ 0.2 | ||||
Note Purchase Agreement [Member] | |||||
Debt Instrument, Unamortized Discount, Total | $ 1.5 | ||||
Debt Instrument, Periodic Payment, Exit Payment, Percent | 2% | ||||
Debt Instrument, Unused Borrowing Capacity, Amount | $ 25 | ||||
Debt Issuance Costs, Gross | $ 1.9 | ||||
Debt Instrument, Interest Rate, Stated Percentage | 8% | 8% | |||
Debt Instrument, Periodic Payment, Percent | 11.11% | ||||
Debt Instrument, Prepayment Fee Percentage | 2% | ||||
Debt Instrument, Interest Rate, Effective Percentage | 10.98% | ||||
Long-term Debt, Total | 100 | ||||
Prepayment Fees on Advances, Net | $ 2 | ||||
Note Purchase Agreement [Member] | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | |||||
Debt Instrument, Basis Spread on Variable Rate | 0.26161% | ||||
Note Purchase Agreement [Member] | Adjusted Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | |||||
Debt Instrument, Basis Spread on Variable Rate | 3.50% | ||||
Note Purchase Agreement [Member] | Minimum [Member] | London Interbank Offered Rate LIBOR 1 [Member] | |||||
Debt Instrument, Basis Spread on Variable Rate | 1.50% | ||||
Note Purchase Agreement [Member] | Maximum [Member] | London Interbank Offered Rate LIBOR 1 [Member] | |||||
Debt Instrument, Basis Spread on Variable Rate | 3.50% | ||||
Oxford Finance Limited Liability Company [Member] | Secured Promissory Notes [Member] | |||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 100 | ||||
Debt Instrument, Face Amount | $ 100 |
Note 9 - Debt - Schedule of Lon
Note 9 - Debt - Schedule of Long Term Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Total debt, inclusive of $2.0 million exit payment | $ 102,000 | |
Less: debt issuance costs and discounts | (3,377) | $ (3,693) |
Total long-term debt, net | $ 98,623 | $ 98,307 |
Note 9 - Debt - Future Minimum
Note 9 - Debt - Future Minimum Principal Payments (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
2024 | $ 33,997 |
2025 | 45,329 |
2026 | 22,674 |
Total | $ 102,000 |
Note 9 - Debt - Schedule of Deb
Note 9 - Debt - Schedule of Debt Issuance Costs and Discounts (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Less: accumulated amortization | $ (2,033) | $ (1,717) |
Included in long-term debt | 3,377 | 3,693 |
Note Purchase Agreement [Member] | ||
Deferred issuance costs and discounts | $ 5,410 | |
Silicon Valley Bank and Oxford Finance [Member] | ||
Deferred issuance costs and discounts | $ 5,410 |
Note 10 - Stockholders' Equit_2
Note 10 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||||||||
Dec. 09, 2022 | Mar. 10, 2022 | Mar. 08, 2022 | Jul. 15, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Oct. 31, 2012 | Oct. 31, 2011 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) | 0 | 0 | |||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||||
Proceeds from Issuance of Private Placement | $ 0 | $ 10,000 | |||||||
Common Stock, Shares Authorized (in shares) | 100,000,000 | 100,000,000 | |||||||
Ordinary Shares Ownership Percentage | 20% | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 3.17 | $ 1.64 | |||||||
Equity Incentive Plan Twenty Eleven [Member] | |||||||||
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 (in shares) | 6,235,783 | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 1,903,626 | ||||||||
Employment Inducement Incentive Award Plan Twenty Seventeen [Member] | |||||||||
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 (in shares) | 927,914 | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 1,205,832 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 3 years | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 1,000,000 | ||||||||
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 | ||||||||
Common Stock [Member] | |||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 3,584,228 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,116,250 | 2,116,250 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 16 | $ 16 | |||||||
Securities Purchase Agreement [Member] | Alan H. Auerbach and Athyrium Opportunities IV Co-Invest 2 [Member] | |||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 1,792,114 | ||||||||
Proceeds from Issuance of Private Placement | $ 5,000 | ||||||||
Securities Purchase Agreement [Member] | Common Stock [Member] | |||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 568,181 | 3,584,228 | |||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | ||||||||
Proceeds from Issuance of Private Placement | $ 10,000 | ||||||||
Share Price (in dollars per share) | $ 4.40 | $ 2.79 | |||||||
Restricted Stock Units (RSUs) [Member] | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period (in shares) | 317,939 | 189,625 | |||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 8,500 | ||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 6 months | ||||||||
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) | $ 4.10 | $ 2.34 | |||||||
Non-vested Stock Options [Member] | |||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 3,500 | ||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 4 months 24 days |
Note 10 - Stockholders' Equit_3
Note 10 - Stockholders' Equity - Fair Value Options Weighted-Average Assumptions (Details) - Warrant To Acquire Common Stock [Member] | Mar. 31, 2023 | Mar. 31, 2022 |
Measurement Input, Expected Dividend Rate [Member] | ||
Warrant measurement Input | 0 | 0 |
Measurement Input, Price Volatility [Member] | ||
Warrant measurement Input | 0.855 | 0.862 |
Measurement Input, Risk Free Interest Rate [Member] | ||
Warrant measurement Input | 0.039 | 0.018 |
Measurement Input, Expected Term [Member] | ||
Warrant measurement Input | 5.63 | 5.50 |
Note 10 - Stockholders' Equit_4
Note 10 - Stockholders' Equity - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based compensation expense | $ 2,838 | $ 3,148 |
Selling, General and Administrative Expenses [Member] | Share-Based Payment Arrangement, Option [Member] | ||
Share-based compensation expense | 758 | 739 |
Selling, General and Administrative Expenses [Member] | Restricted Stock Units (RSUs) [Member] | ||
Share-based compensation expense | 1,207 | 1,460 |
Research and Development Expense [Member] | Share-Based Payment Arrangement, Option [Member] | ||
Share-based compensation expense | 152 | 137 |
Research and Development Expense [Member] | Restricted Stock Units (RSUs) [Member] | ||
Share-based compensation expense | $ 721 | $ 812 |
Note 10 - Stockholders' Equit_5
Note 10 - Stockholders' Equity - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Granted, shares (in shares) | 581,614 | |
Nonvested, shares (in shares) | 1,141,605 | 799,376 |
The 2011 and 2017 Plans [Member] | ||
Balance, shares (in shares) | 4,212,481 | |
Balance, weighted average exercise price (in dollars per share) | $ 59.59 | |
Outstanding, weighted average remaining contractual term (Year) | 5 years 6 months | 5 years 1 month 6 days |
Outstanding, aggregate intrinsic value | $ 383 | $ 1,046 |
Granted, shares (in shares) | 581,614 | |
Granted, weighted average exercise price (in dollars per share) | $ 4.39 | |
Granted, weighted average remaining contractual term (Year) | 9 years 10 months 24 days | |
(Expired), shares (in shares) | (42,893) | |
(Expired), weighted average exercise price (in dollars per share) | $ 116.94 | |
Balance, shares (in shares) | 4,751,202 | 4,212,481 |
Balance, weighted average exercise price (in dollars per share) | $ 52.31 | $ 59.59 |
Nonvested, shares (in shares) | 1,141,605 | |
Nonvested, weighted average exercise price (in dollars per share) | $ 5.05 | |
Nonvested, weighted average remaining contractual term (Year) | 9 years 3 months 18 days | |
Nonvested, aggregate intrinsic value | $ 199 | |
Exercisable, shares (in shares) | 3,609,597 | |
Exercisable, weighted average exercise price (in dollars per share) | $ 67.26 | |
Exercisable, weighted average remaining contractual term (Year) | 4 years 4 months 24 days | |
Exercisable, aggregate intrinsic value | $ 183 |
Note 10 - Stockholders' Equit_6
Note 10 - Stockholders' Equity - Stock Options Rollforward (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Nonvested shares (in shares) | 799,376 | |
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 4.25 | |
Granted, shares (in shares) | 581,614 | |
Granted, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 3.17 | $ 1.64 |
(Vested), shares (in shares) | (239,385) | |
(Vested), Weighted Average Grant-Date Fair Value (in dollars per share) | $ 4.65 | |
Nonvested shares (in shares) | 1,141,605 | |
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 3.62 |
Note 10 - Stockholders' Equit_7
Note 10 - Stockholders' Equity - Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Nonvested shares (in shares) | 1,501,767 | |
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 4.92 | |
Granted shares (in shares) | 1,264,527 | |
Granted, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 4.10 | $ 2.34 |
(Vested) shares (in shares) | (317,939) | (189,625) |
(Vested), Weighted Average Grant-Date Fair Value (in dollars per share) | $ 4.94 | |
(Forfeited) shares (in shares) | (35,860) | |
(Forfeited), Weighted Average Grant-Date Fair Value (in dollars per share) | $ 5.25 | |
Nonvested shares (in shares) | 2,412,495 | |
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value (in dollars per share) | $ 4.48 |
Note 11 - 401(k) Savings Plan (
Note 11 - 401(k) Savings Plan (Details Textual) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Defined Contribution Plan, Cost | $ 0.5 | $ 0.4 |
First 3% of Each Participant's Contributions [Member] | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 100% | |
Second Two Percent Of Each Participants Contributions [Member] | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 50% |
Note 12 - Commitments and Con_2
Note 12 - Commitments and Contingencies (Details Textual) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Nov. 01, 2024 USD ($) | Nov. 07, 2022 USD ($) | Jun. 23, 2021 USD ($) | Mar. 02, 2020 USD ($) | Mar. 15, 2019 USD ($) | Jan. 31, 2023 USD ($) | Sep. 30, 2021 USD ($) | Mar. 31, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Oct. 31, 2022 USD ($) | Jul. 18, 2014 USD ($) | |
Milestone Payments Maximum Amount | $ 187.5 | |||||||||||
Percentage of Unpaid Portion of Milestone Payments Interest Rate | 6.25% | |||||||||||
Milestone Payment | $ 1.8 | |||||||||||
Eshelman v. Puma Biotechnology, Inc. [Member] | ||||||||||||
Litigation Settlement, Expense | $ 3 | |||||||||||
Litigation Settlement, Amount Awarded to Other Party | $ 16 | $ 26.3 | ||||||||||
Loss Contingency Accrual, Period Increase (Decrease), Total | $ (22.4) | |||||||||||
Loss Contingency, Estimate of Possible Loss | $ 16 | |||||||||||
Legal Settlements Payments, Number of Installments | 2 | 2 | ||||||||||
Payments for Legal Settlements | $ 8 | |||||||||||
Eshelman v. Puma Biotechnology, Inc. [Member] | Forecast [Member] | ||||||||||||
Payments for Legal Settlements | $ 8 | |||||||||||
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 | |||||||||||
Pfizer License Agreement [Member] | ||||||||||||
Milestone Payment | $ 12.5 | |||||||||||
Takeda [Member] | ||||||||||||
Milestone Payments Maximum Amount | 287.3 | |||||||||||
Upfront License Fee | $ 7 | |||||||||||
Research and Development Expense | $ 7 | |||||||||||
NERLYNX [Member] | ||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 250 | $ 250 |