| 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 subsidiary. All intercompany balances and transactions have been eliminated in consolidation. Segment Reporting: Management has determined that the Company operates in one business segment, which is the development and commercialization of innovative products to enhance cancer care. 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. Net In come per S Basic net income per share of common stock is computed by dividing net income 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 RSUs granted in connection with the Puma Biotechnology, Inc. 2011 2017 For the Three Months Ended For the Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Options outstanding 3,850,575 4,211,389 3,850,575 4,211,389 Warrant outstanding 2,116,250 2,116,250 2,116,250 2,116,250 Unvested restricted stock units 751,139 1,087,224 751,139 1,111,286 Totals 6,717,964 7,414,863 6,717,964 7,438,925 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 income per share of common stock computations is as follows (in thousands, except share and per share amounts): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2024 2023 2024 2023 Numerator: Net income $ 20,317 $ 5,796 $ 10,973 $ 9,323 Denominator: Weighted average common stock outstanding for basic net income per share 49,008,464 47,520,338 48,498,579 46,977,127 Net effect of dilutive common stock equivalents 164,897 298,896 526,524 420,082 Weighted average common stock outstanding for diluted net income per share 49,173,361 47,819,234 49,025,103 47,397,209 Net income per share of common stock Basic $ 0.41 $ 0.12 $ 0.23 $ 0.20 Diluted $ 0.41 $ 0.12 $ 0.22 $ 0.20 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 nine September 30, 2024 2023 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 September 30, 2024 not September 30, 2024 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 condensed 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 September 30, 2024 t In September 2024, . As of September 30, 2024, 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 $24.4 million and $30.6 million for the three nine September 30, 2024 three nine September 30, 2023 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 RSUs 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—Stockhol ders’ Eq 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 September 30, 2024 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. September 30, 2024 and December 31, 2023 , the Company had restricted cash in the amount of approximately $2.1 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 September 30, 2024 December 31, 2023 1 2 3 September 30, 2024 Level 1 Level 2 Level 3 Total Cash equivalents $ 14,172 $ 46,298 $ — $ 60,470 U.S. Government 11,998 — — 11,998 Commercial paper — 17,464 — 17,464 $ 26,170 $ 63,762 $ — $ 89,932 December 31, 2023 Level 1 Level 2 Level 3 Total Cash equivalents $ 29,068 $ 8,490 $ — $ 37,558 U.S. Government $ 3,444 $ — $ — $ 3,444 Commercial paper — 7,910 — 7,910 Totals $ 32,512 $ 16,400 $ — $ 48,912 The Company’s investments in commercial paper and U.S. government securities are exposed to price fluctuations. The fair value measurements for commercial paper 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 September 30, 2024 (in years) Cost Gains Losses Fair Value Cash equivalents $ 60,470 $ — $ — $ 60,470 U.S. Government Less than 1 11,991 8 (1 ) 11,998 Commercial paper Less than 1 17,446 23 (5 ) 17,464 Totals $ 89,907 $ 31 $ (6 ) $ 89,932 Maturity Amortized Unrealized Estimated December 31, 2023 (in years) Cost Gains Losses Fair Value Cash equivalents $ 37,561 $ — $ (3 ) $ 37,558 U.S. Government $ 3,443 $ 1 $ — $ 3,444 Commercial paper Less than 1 7,912 1 (3 ) 7,910 Totals $ 48,916 $ 2 $ (6 ) $ 48,912 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 September 30, 2024 were approximately million. The Company does 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 creditworthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions. The Company also sells its products to international customers through sub-licensees. Royalty revenue consists of consideration earned related to international sales of NERLYNX made by the Company’s sub-licensees in their respective territories. A majority of the Company's royalty revenue is generated from sales into the China market. 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 September 30, 2024 December 31, 2023 September 30, 2024 December 31, 2023 Raw materials $ 211 $ 5,693 Work-in-process (materials, labor and overhead) 2,005 820 Finished goods (materials, labor and overhead) 457 567 Total inventories $ 2,673 $ 7,080 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 that 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 September 30, 2024 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 $2 50.0 2022, three March 31, 2023. 2030. million and $7.3 million for the three nine September 30, 2024 and 2023 September 30, 2024 estimated future amortization expense related to the Company’s intangible assets is approximately million for the remainder of 2024 and $9.7 million for each year starting 2025 2029, million for 2030. Recently Issued Accounting Standar ds: In October 2023, 2023 06, Disclosure Improvements – Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative not two X not not 2023 06 In December 2023, 2023 09, Income Taxes (Topic 740 2023 09 December 15, 2025. 2023 09 ASU 2023 07, Segme 280 2023 07 December 15, 2023 December 15, 2024, not |
