Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | Apr. 30, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | PBYI | |
Entity Registrant Name | PUMA BIOTECHNOLOGY, INC. | |
Entity Central Index Key | 0001401667 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity Common Stock, Shares Outstanding | 40,361,916 | |
Entity File Number | 001-35703 | |
Entity Tax Identification Number | 77-0683487 | |
Entity Address, Address Line One | 10880 Wilshire Boulevard | |
Entity Address, Address Line Two | 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 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 95,653 | $ 85,293 |
Marketable securities | 13,397 | 8,096 |
Accounts receivable, net of allowance for credit loss of $1,000 and $1,000 | 26,158 | 25,543 |
Inventory, net | 7,745 | 3,454 |
Prepaid expenses, current | 11,589 | 11,262 |
Restricted cash, current | 8,850 | 8,850 |
Other current assets | 373 | 3,641 |
Total current assets | 163,765 | 146,139 |
Lease right-of-use assets, net | 15,834 | 16,404 |
Property and equipment, net | 2,283 | 2,481 |
Intangible assets, net | 72,136 | 74,140 |
Restricted cash, long-term | 3,311 | 3,311 |
Prepaid expenses and other, long-term | 1,330 | 1,745 |
Total assets | 258,659 | 244,220 |
Current liabilities: | ||
Accounts payable | 10,654 | 12,076 |
Accrued expenses, current | 79,284 | 61,325 |
Accrued in-licensed rights, current | 21,301 | 20,993 |
Post-marketing commitment liability, current | 3,092 | 2,481 |
Lease liabilities, current | 3,220 | 3,094 |
Current portion of long-term debt | 22,857 | 14,286 |
Total current liabilities | 140,408 | 114,255 |
Accrued expenses, long-term | 1,140 | 25,963 |
Lease liabilities, long-term | 18,710 | 19,549 |
Post-marketing commitment liability, long-term | 5,618 | 6,379 |
Long-term debt | 76,346 | 84,025 |
Total liabilities | 242,222 | 250,171 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity (deficit): | ||
Common stock - $.0001 par value per share; 100,000,000 shares authorized; 40,324,263 shares issued and outstanding at March 31, 2021 and 40,086,387 issued and outstanding at December 31, 2020 | 4 | 4 |
Additional paid-in capital | 1,337,536 | 1,331,676 |
Accumulated deficit | (1,321,103) | (1,337,631) |
Total stockholders' equity (deficit) | 16,437 | (5,951) |
Total liabilities and stockholders' equity (deficit) | $ 258,659 | $ 244,220 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Allowance for credit loss | $ 1,000 | $ 1,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 40,324,263 | 40,086,387 |
Common stock, shares outstanding | 40,324,263 | 40,086,387 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenue: | ||
Total revenue | $ 98,169 | $ 51,217 |
Operating costs and expenses: | ||
Cost of sales | 29,557 | 9,076 |
Selling, general and administrative | 28,238 | 30,937 |
Research and development | 20,228 | 25,455 |
Total operating costs and expenses | 78,023 | 65,468 |
Income (loss) from operations | 20,146 | (14,251) |
Other income (expenses): | ||
Interest income | 13 | 386 |
Interest expense | (3,450) | (3,068) |
Legal verdict expense | (185) | (93) |
Other income | 42 | 93 |
Total other expenses | (3,580) | (2,682) |
Net income (loss) before income taxes | 16,566 | (16,933) |
Income tax expense | (38) | |
Net income (loss) | $ 16,528 | $ (16,933) |
Net income (loss) per share of common stock—basic | $ 0.41 | $ (0.43) |
Net income (loss) per share of common stock—diluted | $ 0.40 | $ (0.43) |
Weighted-average shares of common stock outstanding—basic | 40,260,864 | 39,291,162 |
Weighted-average shares of common stock outstanding—diluted | 40,894,868 | 39,291,162 |
Product Revenue, Net | ||
Revenue: | ||
Total revenue | $ 45,816 | $ 48,609 |
License Revenue | ||
Revenue: | ||
Total revenue | 50,000 | 2,000 |
Royalty Revenue | ||
Revenue: | ||
Total revenue | $ 2,353 | $ 608 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net income (loss) | $ 16,528 | $ (16,933) |
Other comprehensive income (loss): | ||
Unrealized loss on available-for-sale securities, net of tax of $0 and $0 | (63) | |
Reclassifications of gain on available-for-sale securities, included in “Other income (expenses)”, net of tax of $0 and $0 | 3 | |
Comprehensive income (loss) | $ 16,528 | $ (16,993) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Unrealized loss on available-for-sale securities, tax | $ 0 | $ 0 |
Reclassifications of gain on available-for-sale securities, included in “Other income (expense)”, tax | $ 0 | $ 0 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2019 | $ 17,463 | $ 4 | $ 1,295,033 | $ 62 | $ (1,277,636) |
Beginning Balance (in shares) at Dec. 31, 2019 | 39,203,304 | ||||
Stock-based compensation | 8,907 | 8,907 | |||
Shares issued or restricted stock units vested under employee stock plans (in shares) | 113,917 | ||||
Reclassification of gain on available-for-sale securities | 3 | 3 | |||
Unrealized loss on available-for-sale securities | (63) | (63) | |||
Net income (loss) | (16,933) | (16,933) | |||
Ending Balance at Mar. 31, 2020 | 9,377 | $ 4 | 1,303,940 | $ 2 | (1,294,569) |
Ending Balance (in shares) at Mar. 31, 2020 | 39,317,221 | ||||
Beginning Balance at Dec. 31, 2020 | $ (5,951) | $ 4 | 1,331,676 | (1,337,631) | |
Beginning Balance (in shares) at Dec. 31, 2020 | 40,086,387 | 40,086,387 | |||
Stock-based compensation | $ 5,860 | 5,860 | |||
Shares issued or restricted stock units vested under employee stock plans (in shares) | 237,876 | ||||
Net income (loss) | 16,528 | 16,528 | |||
Ending Balance at Mar. 31, 2021 | $ 16,437 | $ 4 | $ 1,337,536 | $ (1,321,103) | |
Ending Balance (in shares) at Mar. 31, 2021 | 40,324,263 | 40,324,263 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating activities: | ||
Net income (loss) | $ 16,528 | $ (16,933) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 2,951 | 1,916 |
Stock-based compensation | 5,860 | 8,907 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (615) | (2,646) |
Inventory, net | (4,291) | (127) |
Prepaid expenses and other | 88 | (1,140) |
Other current assets | 3,268 | 18 |
Accounts payable | (1,422) | (1,928) |
Accrued expenses and other | (6,556) | 434 |
Deferred rent | (41) | |
Post-marketing commitment liability | (150) | |
Net cash provided by (used in) operating activities | 15,661 | (11,540) |
Investing activities: | ||
Purchase of available-for-sale securities | (10,696) | |
Maturity of available-for-sale securities | 5,395 | 34,377 |
Net cash (used in) provided by investing activities | (5,301) | 34,377 |
Net increase in cash, cash equivalents and restricted cash | 10,360 | 22,837 |
Cash, cash equivalents and restricted cash, beginning of period | 97,454 | 73,210 |
Cash, cash equivalents and restricted cash, end of period | 107,814 | 96,047 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Intangibles in accrued expenses | 20,000 | |
Property and equipment purchases in accounts payable | 13 | |
Supplemental disclosure of cash flow information: | ||
Interest paid | 2,250 | $ 2,275 |
Income taxes paid | $ 12 |
Business and Basis of Presentat
Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Business and Basis of Presentation | Note 1—Business and Basis of Presentation: Business: Puma Biotechnology, Inc., or the Company, is a biopharmaceutical company based in Los Angeles, California with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses from Pfizer, Inc., or Pfizer, the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357, as well as certain related compounds. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors HER1, HER2 and HER4. Currently, the Company is primarily focused on the development and commercialization of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer and HER2 mutated cancers. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including other tumor types that over-express or have a mutation in HER2 or EGFR, such as breast cancer, cervical cancer, lung cancer or other solid tumors. The Company has two subsidiaries, Puma Biotechnology Ltd., a United Kingdom company, and Puma Biotechnology, B.V., a Netherlands company. These subsidiaries were established for the purpose of legal representation in the United Kingdom and the European Union. Basis of Presentation: The Company has incurred significant operating losses since its inception. The Company believes that it will continue to incur net losses and may incur negative net cash flows from operating activities through the drug development process and global commercialization. In 2017, the Company received U.S. Food and Drug Administration, or FDA, approval for its first product, NERLYNX® (neratinib), formerly known as PB272 (neratinib, oral), for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Following FDA approval in July 2017, NERLYNX became available by prescription in the United States, and the Company commenced commercialization. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. In 2018, the European Commission, or EC, granted marketing authorization for NERLYNX in the European Union for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab-based therapy. 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, Mexico, South Korea, and various countries and territories in Central and South America. The Company plans to continue to pursue commercialization of NERLYNX in other countries outside the United States, if approved. The Company has reported net income of approximately $16.5 million and cash flows from operations of approximately $15.7 million for the three months ended March 31, 2021. The Company’s Since its inception through March 31, 2021, the Company’s financing has primarily been proceeds from product and license revenue, public offerings of its common stock, private equity placements, and borrowings under its loan and security agreement. |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 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 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 U.S. generally accepted accounting principles, or GAAP, requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of revenues and expenses for the period presented. Accordingly, actual results could differ from those estimates. Significant estimates include estimates for variable consideration for which reserves were established. These estimates are included in the calculation of net revenues and include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products. Net Income (Loss) per Share of Common Stock: Basic net income (loss) per share of common stock is computed by dividing net income (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, or ASC, 260, Earnings per Share For the three months ended March 31, 2020, potentially dilutive securities excluded from the calculations were shares issuable upon exercise of options, shares issuable upon exercise of a warrant, and shares underlying RSUs that were subject to vesting and were antidilutive A reconciliation of the numerators and denominators of the basic and diluted net income (loss) per share of common stock computations is as follows (in thousands, except per share amounts): For the Three Months Ended March 31, 2021 2020 Numerator: Net income (loss) $ 16,528 $ (16,933 ) Denominator: Weighted average common stock outstanding for basic net income (loss) per share 40,261 39,291 Net effect of dilutive common stock equivalents 634 — Weighted average common stock outstanding for diluted net income (loss) per share 40,895 39,291 Net income (loss) per share of common stock Basic $ 0.41 $ (0.43 ) Diluted $ 0.40 $ (0.43 ) Revenue Recognition: Under ASC Topic 606, Revenue from Contracts with Customers 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 and 68 days 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 year or less. However, no such costs were incurred during the three months ended March 31, 2021 and 2020. Reserves for Variable Consideration: Revenue from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the related sales, and are classified as reductions of accounts receivable, net when the right of offset exists in accordance with ASU 2013-1, Balance Sheet (Topic 210): Clarifying the Scope of Disclosures about Offsetting Assets and Liabilities, The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a significant reversal of revenue would not be probable to occur in a future period for the estimates detailed below as of March 31, 2021 and, therefore, the transaction price was not reduced further during the quarter ended March 31, 2021. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. 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 distinct from the Company’s sale of products to its customers and, therefore, these payments have been recorded as a reduction of revenue within the statements of operations. 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 be returned by its customers and records this estimate as a reduction of product revenue, net in the period the related product revenue is recognized, as well as a reduction to accounts receivable, net on the consolidated balance sheets. The Company currently estimates product returns using its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has an insignificant amount of returns to date and believes that returns of its products will continue to be minimal. 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 yet issued a payment 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 been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimates of future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel at the end of each reporting period. 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. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. The Company evaluates these agreements under ASC 606 to determine the distinct performance obligations. Non-refundable, upfront fees that are not contingent on any future performance and require no consequential continuing involvement by the Company, are recognized as revenue when the license term commences and the licensed data, technology or product is delivered. The Company defers recognition of non-refundable upfront license fees if the performance obligations are not satisfied. 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 occur and when the uncertainty associated with the variable consideration is subsequently resolved. 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, the Company has entered into sub-license agreements with certain sub-licensees in territories outside of the United States. These sub-licensing agreements grant certain intellectual property rights and set forth various respective obligations with respect to actions such as development, pursuit and maintenance of regulatory approvals, commercialization and supply of NERLYNX in the sub-licensees’ respective territories. License fees under the sub-license agreements include one-time upfront payments when each sub-license agreement was executed and potential additional one-time milestone payments due to the Company upon successful completion of certain performance obligations, such as achieving regulatory approvals or sales target thresholds, and potential double-digit royalties on sales of the licensed product, calculated as a percentage of net sales of the licensed product throughout each sub-licensee’s respective territory. During the first quarter of 2021, the Company entered into an amendment to an existing sub-license agreement granting the sub-licensee development, manufacturing and commercial rights to NERLYNX in greater China. Pursuant to the amendment, the Company received and recognized as license revenue an upfront payment of $50.0 million during the first quarter of 2021. The beginning balance of accounts receivable, net on the Company’s consolidated balance sheet for license revenue from the sub-license agreements for the three months ended March 31, 2021 was $2.5 million. As of March 31, 2021, $2.0 million in license revenue from the sub-license agreements is included in accounts receivable, net and $1.0 million in the allowance for credit loss on the consolidated balance sheet Royalty Revenue: For sub-license agreements that are within the scope of ASC 606, the Company recognizes revenue when the related sales occur in accordance with the sales-based royalty exception under ASC 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 $2.4 million for the three months ended March 31, 2021. 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 13-Commitments and Contingencies). Royalty Expenses: Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 13 — Research and Development Expenses: Research and development expenses, or 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-party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs. Clinical trial expenses include, but are not limited to, investigator fees, site costs, comparator drug costs, and clinical research organization, or CRO, costs. In the normal course of business, the Company contracts with third parties to perform various clinical trial activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variations from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients and the completion of portions of the clinical trial or similar conditions. The Company’s accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs. As actual costs become known, the Company adjusts its accruals in that period. In instances where the Company enters into agreements with third parties for clinical trials and other consulting activities, upfront amounts are recorded to prepaid expenses and other in the accompanying consolidated balance sheets and expensed as services are performed or as the underlying goods are delivered. If the Company does not expect the services to be rendered or goods to be delivered, any remaining capitalized amounts for non-refundable upfront payments are charged to expense immediately. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. 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. Stock-Based Compensation: Stock Option Awards : ASC Topic 718, Compensation-Stock Compensation 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 (refer to Note 11 for further details) granted to employees and nonemployees are normally valued at the fair value of the instrument on the grant date and are recognized in the statement of operations over the requisite service period. When the requisite service period precedes the grant date and a market condition exists in the warrant, the Company values the warrant using the Monte Carlo Simulation Method. When the terms of the warrant become fixed, the Company values the warrant using the Black-Scholes Option Pricing Method. As allowed by ASC 718, the Company’s estimate of expected volatility is based on its average volatilities using its publicly traded history. The risk-free rate for periods within the contractual life of the warrant is based on the U.S. Treasury yield curve in effect at the time of grant valuation. In determining the value of the warrant until the terms are fixed, the Company factors in the probability of the market condition occurring and several possible scenarios. When the requisite service period precedes the grant date and is deemed to be complete, the Company records the fair value of the warrant at the time of issuance as an equity stock-based compensation transaction. The grant date is determined when all pertinent information, such as exercise price and quantity are known. Income Taxes: The Company follows ASC Topic 740, Income Taxes 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, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position should be measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. ASC 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. As of March 31, 2021, the Company’s uncertain tax position reserves include a reserve for its R&D credits. Financial Instruments: The carrying value of financial instruments, such as cash equivalents, accounts receivable and accounts payable, approximate their fair value because of their short-term nature. The carrying value of long-term debt approximates its fair value as the principal amounts outstanding are subject to variable interest rates that are based on market rates, which are regularly reset. Cash and Cash Equivalents: The Company classifies all highly liquid instruments with an original maturity of three months or less as cash equivalents. Restricted Cash: Restricted cash represents cash held at financial institutions that is pledged as collateral for stand-by letters of credit for lease and legal verdict commitments. The lease-related letters of credit will lapse at the end of the respective lease terms through 2026. At March 31, 2021 Investment Securities: The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities may be required prior to maturity to implement management’s strategies. These securities are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. In accordance with ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Assets Measured at Fair Value on a Recurring Basis: ASC Topic 820, Fair Value Measurement Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs are observable in active markets. Level 3: Valuations derived from valuation techniques in which one or more significant inputs are unobservable. Following are the major categories of assets measured at fair value on a recurring basis as of March 31, 2021 and December 31, 2020, using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3) (in thousands): March 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents $ 66,424 $ — $ — $ 66,424 Commercial paper — 11,093 — 11,093 Corporate bonds — 2,304 — 2,304 Totals $ 66,424 $ 13,397 $ — $ 79,821 December 31, 2020 Level 1 Level 2 Level 3 Total Cash equivalents $ 59,919 $ 11,798 $ — $ 71,717 Commercial paper — 8,096 — 8,096 Totals $ 59,919 $ 19,894 $ — $ 79,813 The Company’s investments in commercial paper, corporate bonds and U.S. government securities are exposed to price fluctuations. The fair value measurements for commercial paper, corporate bonds and U.S. government securities are based upon the quoted prices of similar items in active markets multiplied by the number of securities owned. The following tables summarize the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Estimated March 31, 2021 (in years) cost Gains Losses fair value Cash equivalents $ 66,424 $ — $ — $ 66,424 Commercial paper Less than 1 11,093 — — 11,093 Corporate bonds Less than 1 2,304 — — 2,304 Totals $ 79,821 $ — $ — $ 79,821 Maturity Amortized Unrealized Estimated December 31, 2020 (in years) cost Gains Losses fair value Cash equivalents $ 71,717 $ — $ — $ 71,717 Commercial paper Less than 1 8,096 — — 8,096 Totals Less than 1 $ 79,813 $ — $ — $ 79,813 Concentration of Risk: Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents, marketable securities, and accounts receivable, net. The Company’s cash and cash equivalents and restricted cash in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at March 31, 2021, were approximately $107.6 million. The Company does not believe it is exposed to any significant credit risk due to the quality nature of the financial instruments in which the money is held. Pursuant to the Company’s internal investment policy, investments must be rated A-1/P-1 or better by Standard and Poor’s Rating Service and Moody’s Investors Service at the time of purchase. 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 recorded $0 and $1.0 million as an allowance for credit loss for the periods ended March 31, 2021 and December 31, 2020, respectively. 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 parties to formulate and manufacture NERLYNX and its drug candidates. The commercialization of NERLYNX and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company has no experience in drug formulation or manufacturing and does not intend to establish its own manufacturing facilities. The Company lacks the resources and expertise to formulate or manufacture NERLYNX and other drug candidates. While the drug candidates were being developed by Pfizer, both the drug substance and drug product were manufactured by third-party contractors. The Company is using the same third-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and the commercialization of NERLYNX. If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on one or more third-party contractors to manufacture the commercial supply of drugs. 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-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within the cost of sales in the consolidated statements of operations. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of sales in the consolidated statements of operations. 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, 2021, the Company’s inventory balance consisted primarily of raw materials purchased subsequent to FDA approval of NERLYNX. 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 years for computer hardware and software, three years for phone equipment, and seven years for furniture and fixtures. Leasehold improvements are amortized using the straight-line method over the lesser of the useful life or the lease term. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred 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 be r |
Accounts Receivable, Net
Accounts Receivable, Net | 3 Months Ended |
Mar. 31, 2021 | |
Accounts Receivable Net [Abstract] | |
Accounts Receivable, Net | Note 3—Accounts Receivable, Net: Accounts receivable, net consisted of the following (in thousands): March 31, 2021 December 31, 2020 Trade accounts receivable $ 22,800 $ 21,515 License revenue receivable 2,000 2,500 Royalty revenue receivable 2,358 2,528 Total accounts receivable $ 27,158 $ 26,543 Allowance for credit losses (1,000 ) (1,000 ) Total accounts receivable, net $ 26,158 $ 25,543 Trade accounts receivable consist entirely of amounts owed from the Company’s customers related to product sales. License revenue receivable represents an amount owed from a sub-licensee under a sub-license agreement. Royalty revenue receivable represents amounts owed related to royalty revenue recognized based on the Company’s sub-licensees’ sales in their respective territories in the periods ended March 31, 2021 and December 31, 2020. For all accounts receivable, the Company recognized credit losses based on lifetime expected losses to selling, general and administrative expense in the consolidated statements of operations. In determining estimated credit losses, the Company evaluated its historical loss rates, current economic conditions and reasonable and supportable forecasts of future economic conditions. The Company recorded $0 and $1.0 million as a credit loss expense for the periods ended March 31, 2021 and December 31, 2020, respectively. The rollforward of the allowance for credit losses is as follows: Allowance for credit losses (in thousands): Beginning balance at January 1, 2021 $ (1,000 ) Provision for credit loss expense — Accounts receivable written-off — Recoveries — Total ending allowance balance as March 31, 2021 $ (1,000 ) |
Prepaid Expenses and Other
Prepaid Expenses and Other | 3 Months Ended |
Mar. 31, 2021 | |
Prepaid Expense And Other Assets [Abstract] | |
Prepaid Expenses and Other | Note 4—Prepaid Expenses and Other: Prepaid expenses and other consisted of the following (in thousands): March 31, 2021 December 31, 2020 Current: CRO services $ 1,308 $ 1,550 Other clinical development 3,322 2,718 Insurance 2,733 3,708 Professional fees 1,083 651 Other 3,143 2,635 11,589 11,262 Long-term: CRO services 198 518 Other clinical development 475 437 Other 657 790 1,330 1,745 Totals $ 12,919 $ 13,007 Other current prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions and software. Other long-term prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions, software, a capitalized sublease commission and a sublease tenant improvement allowance, net of amortization. |
Other Current Assets
Other Current Assets | 3 Months Ended |
Mar. 31, 2021 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Other Current Assets | Note 5—Other Current Assets: Other current assets consisted of the following (in thousands): March 31, 2021 December 31, 2020 Deposit for manufacturing costs $ — $ 3,376 Deferred rent 198 198 Other 175 67 Totals $ 373 $ 3,641 Other current asset amounts consist primarily of a deposit, capitalized sublease commission and a sublease tenant improvement allowance, net of amortization. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Leases | Note 6—Leases: In December 2011, the Company entered into a non-cancelable operating lease for office space in Los Angeles, California, which was subsequently amended in November 2012, December 2013, March 2014, July 2015, and December 2017. The initial term of the lease was for seven years and commenced on December 10, 2011. As amended, the Company rents approximately 65,656 square feet. The term of the lease runs until March 2026, and rent amounts payable by the Company increase approximately 3% per year. Concurrent with the execution of the lease, the Company provided the landlord an automatically renewable stand-by letter of credit in the amount of $2.0 million. The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, long-term on the accompanying consolidated balance sheets. In June 2012, the Company entered into a long-term lease agreement for office space in South San Francisco, California, which was subsequently amended in May 2014 and July 2015. As amended, the Company rents approximately 29,470 square feet. The term of this lease runs until March 2026, with the option to extend for an additional five-year The Company also leases copier equipment for use in the office spaces. Components of lease expense include fixed lease expense and variable lease expense of approximately $1.2 million and $0.1 million, respectively, for each of the three months ended March 31, 2021 and March 31, 2020. For purposes of determining straight-line rent expense, the lease term is calculated from the date the Company first takes possession of the facility, including any periods of free rent and any renewal option periods that the Company is reasonably certain of exercising. The Company’s office and equipment leases generally have contractually specified minimum rent and annual rent increases that are included in the measurement of the ROU asset and related lease liability. Additionally, under these lease arrangements, the Company may be required to pay directly, or reimburse the lessors, for real estate taxes, insurance, utilities, maintenance and other operating costs. Such amounts are generally variable and therefore not included in the measurement of the ROU asset and related lease liability but are instead recognized as variable lease expense in selling, general and administrative costs in the consolidated statements of operations when they are incurred Supplemental cash flow information related to leases for the three months ended March 31, 2021: Operating cash flows used for operating leases (in thousands) $ 1,380 Right-of-use assets obtained in exchange for new operating lease liabilities — Weighted average remaining lease term (in years) 5.0 Weighted average discount rate 10.9 % The future minimum lease payments under ASC 842 as of March 31, 2021 were as follows (in thousands): Amount 2021 (remaining) 4,054 2022 5,483 2023 5,631 2024 5,805 2025 5,983 Thereafter 1,508 Total minimum lease payments $ 28,464 Less: imputed interest (6,534 ) Total lease liabilities $ 21,930 In February 2019, the Company entered into a long-term sublease agreement for 12,429 square feet of the office space in Los Angeles, California. The term of the lease runs until March 2026 and rent amounts payable to the Company increase approximately 3% per year. The Company recorded operating sublease income of $0.1 million for the three months ended March 31, 2021, respectively, in other income (expenses) in the consolidated statements of operations. The future minimum lease payments to be received as of March 31, 2021 were as follows (in thousands): Amount 2021 (remaining) $ 351 2022 481 2023 495 2024 510 2025 525 Thereafter 134 Total $ 2,496 |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Note 7 —Property and Equipment , Net : Property and equipment, net consisted of the following (in thousands ): March 31, 2021 December 31, 2020 Leasehold improvements $ 3,779 $ 3,779 Computer equipment 2,192 2,192 Telephone equipment 302 302 Furniture and fixtures 2,359 2,359 8,632 8,632 Less: accumulated depreciation (6,349 ) (6,151 ) Totals $ 2,283 $ 2,481 For the three months ended March 31, 2021, the Company incurred depreciation expense of $0.2 million. |
Intangible Assets, Net
Intangible Assets, Net | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | Note 8—Intangible Assets, Net: Intangible assets, net consisted of the following (in thousands): March 31, 2021 December 31, 2020 Acquired and in-licensed rights $ 90,000 $ 90,000 Less: accumulated amortization (17,864 ) (15,860 ) Total intangible asset, net $ 72,136 $ 74,140 For the three months ended March 31, 2021, the Company incurred amortization expense ( ). The estimated remaining useful life of the intangible assets as of March 31, 2021 is 9.0 years. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Note 9—Accrued Expenses: Accrued expenses consisted of the following (in thousands): March 31, 2021 December 31, 2020 Current: Accrued legal verdict expense $ 47,731 $ 22,724 Accrued royalties 7,934 8,604 Accrued CRO services 1,795 3,474 Accrued variable consideration 9,050 9,014 Accrued bonus 2,039 7,788 Accrued compensation 5,135 4,820 Accrued other clinical development 1,512 1,904 Accrued professional fees 1,424 1,420 Accrued legal fees 1,599 383 Accrued manufacturing costs 476 752 Other 589 442 79,284 61,325 Long-term: Accrued legal verdict expense — 24,822 Accrued CRO services 934 908 Accrued other 206 233 1,140 25,963 Totals $ 80,424 $ 87,288 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 royalties represent royalties incurred in connection with the Company’s license agreement with Pfizer. Accrued compensation includes accrued commissions and accrued vacation, which is accrued at the rate the employee earns vacation and reduced as vacation is used by the employee. Accrued variable consideration represents estimates of adjustments to product revenue, net for which reserves are established. Current accrued legal verdict expense includes an estimate of $22.9 million that may be owed to the plaintiff as a result of the jury verdict in Eshelman v. Puma Biotechnology, Inc., et al. Additionally, current accrued legal verdict expense includes the Company’s estimate of $24.9 million that may be owed to class action participants as a result of the jury verdict in Hsu v. Puma Biotechnology, Inc., et al Hsu Hsu Hsu Hsu Other current accrued expenses consist primarily of business license fees, one half of the portion of employer Social Security payroll taxes deferred under the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, and other taxes, insurance and marketing fees. Other long-term accrued expenses consist primarily of one half of the portion of employer Social Security payroll taxes deferred under the CARES Act, accrued compensation and deposit from a sublessee. All accrued expenses are adjusted in the period the actual costs become known. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Note 10—Debt: Long term debt consisted of the following (in thousands): Loan and Security Agreement: March 31, 2021 Maturity Date Total debt $ 100,000 June 1, 2024 Accretion of final interest payment 3,675 Less: current portion of long-term debt (22,857 ) Less: deferred financing costs (4,472 ) Total long-term debt, net $ 76,346 On June 28, 2019, or the Effective Date, the Company entered into an amendment and restatement of its loan and security agreement, which provided for a new credit facility, or the New Credit Facility, with Oxford Finance, LLC, or Oxford, as collateral agent, and the lenders party thereto from time to time, including Oxford, pursuant to which the Company repaid its outstanding debt, as well as all applicable exit and prepayment fees, owed to the lenders under its prior credit facility, using cash on hand and $100.0 million in new borrowings from the New Credit Facility. Under the New Credit Facility, the Company issued to Oxford new and/or replacement secured promissory notes in an aggregate principal amount for all such promissory notes of $100.0 million evidencing the New Credit Facility. No additional money remains available to the Company under the New Credit Facility. The New Credit Facility is secured by substantially all of the Company’s personal property other than its intellectual property. The Company also pledged 65% of the issued and outstanding capital stock of its subsidiaries, Puma Biotechnology Ltd. and Puma Biotechnology B.V. The New Credit Facility limits the Company’s ability to grant any interest in its intellectual property to certain permitted licenses and permitted encumbrances set forth in the agreement. The term loans under the New Credit Facility bear interest at an annual rate equal to the greater of (i) 9.0% and (ii) the sum of (a) the “prime rate,” as reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 3.5%. The Company is required to make monthly interest-only payments on each term loan under the New Credit Facility commencing on the first calendar day of the calendar month following the funding date of such term loan, and continuing on the first calendar day of each calendar month thereafter through August 1, 2021, or the Amortization Date. Commencing on the Amortization Date, and continuing on the first calendar day of each calendar month thereafter, the Company will make consecutive equal monthly payments of principal, together with applicable interest, in arrears to each lender under the New Credit Facility, calculated pursuant to the New Credit Facility. All unpaid principal and accrued and unpaid interest with respect to each term loan under the New Credit Facility is due and payable in full on June 1, 2024, or the Maturity Date. Upon repayment of such term loans, the Company is also required to make a final payment to the lenders equal to At the Company’s option, the Company may prepay the outstanding principal balance of any term loan in whole but not in part, subject to a prepayment fee of 3.0% of any amount prepaid if the prepayment occurs through and including the first anniversary of the funding date of such term loan, 2.0% of the amount prepaid if the prepayment occurs after the first anniversary of the funding date of such term loan through and including the second anniversary of the funding date of such term loan, and 1.0% of the amount prepaid if the prepayment occurs after the second anniversary of the funding date of such term loan and prior to the Maturity Date. The New Credit Facility includes affirmative and negative covenants applicable to the Company, its current subsidiaries and any subsidiaries the Company creates in the future. 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 Company must also achieve certain product revenue targets, measured as of the last day of each fiscal quarter on a trailing year-to-date basis. New minimum revenue levels will be established for each subsequent fiscal year by mutual agreement of the Company, Oxford, as collateral agent, and the lenders under the New Credit Facility. 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 New Credit Facility also includes events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 5.0% and would provide Oxford, as collateral agent, with the right to exercise remedies against the Company and the collateral securing the New Credit Facility, including foreclosure against the property securing the New Credit Facility, including the Company’s cash. These events of default include, among other things, the Company’s failure to pay principal or interest due under the New Credit Facility, a breach of certain covenants under the New Credit Facility, the Company’s insolvency, a material adverse change, the occurrence of any default under certain other indebtedness in an amount greater than $500,000 and one or more judgments against the Company in an amount greater than $500,000 individually or in the aggregate that remains unsatisfied, unvacated, or unstayed for a period of 10 days after its entry. On February 27 and Oxford to establish the Company’s minimum revenue thresholds trailing March 31, June 30, On August 5, 2020 the Company and Oxford amended the New Credit Facility to amend the minimum revenue thresholds for the trailing year-to-date periods ending September 30 and December 31, 2020. On February 3, 2021, the Company and Oxford amended the New Credit Facility to establish the Company’s minimum revenue thresholds for the trailing year-to-date periods ending March 31, June 30, September 30 and December 31, 2021. As of March 31, 2021, there were $100.0 million in term loans outstanding under the New Credit Facility, representing all of the Company’s long-term debt outstanding as of that date, and the Company was in compliance with all applicable covenants under the New Credit Facility. The future minimum principal payments under the New Credit Facility as of March 31, 2021 were as follows (in thousands): Amount 2021 (remaining) $ 14,286 2022 34,286 2023 34,286 2024 17,142 Thereafter — Total $ 100,000 Deferred Financing Costs Deferred financing costs consisted of the following (in thousands): March 31, 2021 December 31, 2020 Deferred financing costs $ 8,668 $ 8,668 Less: accumulated amortization (4,196 ) (3,666 ) Included in long-term debt $ 4,472 $ 5,002 Deferred financing costs are financing costs related to the Company’s outstanding debt. Amortization of debt issuance costs is expensed using the effective interest method and is included in interest expense in the consolidated statement of operations. For each of the three months ended March 31, 2021 and 2020, the Company recorded approximately $0.5 million of interest expense related to the amortization of debt issuance costs in the consolidated statements of operations. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Note 11—Stockholders’ Equity: Common Stock: The Company issued 0 and 500 shares of common stock upon exercise of stock options during the three months ended March 31, 2021 and 2020, respectively. The Company issued 237,876 and 113,417 shares of common stock upon vesting of RSUs during the three months ended March 31, 2021 and 2020, respectively. 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, the Company issued an anti-dilutive warrant to Alan Auerbach, the Company’s founder and Chief Executive Officer. The warrant was issued to provide Mr. Auerbach with the right to maintain ownership of at least 20% of the Company’s common stock in the event that the Company raised capital through the sale of its securities in the future. In connection with the closing of a public offering in October 2012, the exercise price and number of shares underlying the warrant issued to Mr. Auerbach were established and, accordingly, the final value of the warrant became fixed. Pursuant to the terms of the warrant, Mr. Auerbach may exercise the warrant to acquire 2,116,250 shares of the Company’s common stock at $16 per share until October 4, 2021. Stock Options and Restricted Stock Units: The Company’s 2011 Incentive Award Plan, as amended, or the 2011 Plan, was adopted by the Company’s Board of Directors on September 15, 2011. Pursuant to the 2011 Plan, the Company may grant incentive stock options and nonqualified stock options, as well as other forms of equity-based compensation. Incentive stock options may be granted only to employees, while consultants, employees, officers and directors are eligible for the grant of nonqualified options under the 2011 Plan. The maximum term of stock options granted under the 2011 Plan is 10 years and the awards generally vest over a three-year 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. 2021 2020 Dividend yield 0.0 % 0.0 % Expected volatility 86.9 % 102.7 % Risk-free interest rate 0.7 % 1.0 % Expected life in years 5.81 5.80 The Company’s 2017 Employment Inducement Incentive Award Plan, as amended, or the 2017 Plan, was adopted by the Company’s Board of Directors on April 27, 2017. Pursuant to the 2017 Plan, the Company may grant stock options and RSUs, as well as other forms of equity-based compensation to employees, as an inducement to join the Company. The maximum term of stock options granted under the 2017 Plan is 10 years and the awards generally vest over a three-year period. The exercise price of stock options granted under the 2017 Plan must be at least equal to the fair market value of such shares on the date of grant. As of March 31, 2021 , a total of 2,000,000 shares of the Company’s common stock have been reserved for issuance under the 2017 Plan. As of March 31, 2021, 1,173,262 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2017 Plan and 452,353 shares of the Company’s common stock are available for future issuance under the 2017 Plan. Stock-based compensation expense was as follows (in thousands): For the Three Months Ended March 31, 2021 2020 Stock-based compensation: Options - Selling, general, and administrative $ 1,007 $ 920 Research and development 228 841 Restricted stock units - Selling, general, and administrative 2,594 3,772 Research and development 2,031 3,374 Total stock-based compensation expense $ 5,860 $ 8,907 Activity with respect to options granted under the 2011 Plan and 2017 Plan is summarized as follows: Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2020 5,009,342 $ 71.42 5.1 $ 3,458 Granted 442,027 $ 12.02 9.9 Expired (33,729 ) $ 77.55 Outstanding at March 31, 2021 5,417,640 $ 66.53 5.2 $ 2,993 Nonvested at March 31, 2021 1,085,182 $ 11.26 9.3 $ 626 Exercisable 4,332,458 $ 80.38 4.2 $ 2,367 At March 31, 2021, total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $8.4 million, which is expected to be recognized over a weighted-average period of 2.1 years. At March 31, 2021, the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $22.3 million, which is expected to be recognized over a weighted-average period of 2.0 years. The weighted-average grant date fair value of options granted during the three months ended March 31, 2021 and 2020 was $8.54 and $7.86 per share, respectively. The weighted average grant date fair value of RSUs awarded during the three months ended March 31, 2021 and 2020 was $12.30 and $10.74 per share, respectively. Stock Option Rollforward Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2020 899,672 $ 8.71 Granted 442,027 8.54 Vested/Issued (256,517 ) 9.66 Nonvested shares at March 31, 2021 1,085,182 $ 8.42 Restricted Stock Unit Rollforward Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2020 1,854,205 $ 13.51 Granted 999,272 12.30 Vested/Issued (237,876 ) 17.60 Forfeited (88,898 ) 13.62 Nonvested shares at March 31, 2021 2,526,703 $ 12.65 |
401(k) Savings Plan
401(k) Savings Plan | 3 Months Ended |
Mar. 31, 2021 | |
Postemployment Benefits [Abstract] | |
401(k) Savings Plan | Note 12—401(k) Savings Plan: During 2012, the Company adopted a 401(k) savings plan for the benefit of its employees. The Company is required to make matching contributions to the 401(k) plan equal to 100% of the first 3% of wages deferred by each participating employee and 50% on the next 2% of wages deferred by each participating employee. The Company incurred expenses for employer matching contributions of approximately $0.6 million and $0.4 million |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 13—Commitments and Contingencies: Contractual Obligations: Contractual obligations represent future cash commitments and liabilities under agreements with third parties, and exclude contingent liabilities for which the Company cannot reasonably predict future payment. The Company’s contractual obligations result primarily from obligations for various contract manufacturing organizations and clinical research organizations, which include potential payments we may be required to make under our agreements. The contracts also contain variable costs and milestones that are hard to predict as they are based on such things as patients enrolled and clinical trial sites. The timing of payments and actual amounts paid under contract manufacturing organization, or CMO, and CRO agreements may be different depending on the timing of receipt of goods or services or changes to agreed-upon terms or amounts for some obligations. Also, those agreements are cancelable upon written notice by the Company and, therefore, not long-term liabilities. License Agreement: In August 2011, the Company entered into an agreement pursuant to which Pfizer agreed to grant it a worldwide license for the development, manufacture and commercialization of PB272 neratinib (oral), PB272 neratinib (intravenous) and PB357, and certain related compounds. The license is exclusive with respect to certain patent rights owned by or licensed to Pfizer. Under the agreement, the Company is obligated to commence a new clinical trial for a product containing one of these compounds within a specified period of time and to use commercially reasonable efforts to complete clinical trials and to achieve certain milestones as provided in a development plan. From the closing date of the agreement through December 31, 2011, Pfizer continued to conduct the existing clinical trials on behalf of the Company at Pfizer’s sole expense. At the Company’s request, Pfizer has agreed to continue to perform certain services in support of the existing clinical trials at the Company’s expense. These services will continue through the completion of the transitioned clinical trials. The license agreement “capped” the out of pocket expense the Company would incur to complete the then existing clinical trials. All agreed upon costs incurred by the Company above the “cost cap” would be reimbursed by Pfizer. The Company exceeded the “cost cap” during the fourth quarter of 2012. In accordance with the license agreement, the Company billed Pfizer for agreed upon costs above the “cost cap” until December 31, 2013. On July 18, 2014, the Company entered into an amendment to the license agreement with Pfizer. The amendment amends the agreement to (1) reduce the royalty rate payable by the Company to Pfizer on sales of licensed products; (2) release Pfizer from its obligation to pay for certain out-of-pocket costs incurred or accrued on or after January 1, 2014 to complete certain ongoing clinical studies; and (3) provide that Pfizer and the Company will continue to cooperate to effect the transfer to the Company of certain records, regulatory filings, materials and inventory controlled by Pfizer as promptly as reasonably practicable. 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 of 2017, the Company triggered a one-time milestone payment pursuant to the agreement. In June 2020, the Company entered into a letter agreement, or the Letter Agreement, with Pfizer relating to the method of payment associated with a one-time milestone payment under the license agreement with Pfizer. The Letter Agreement permits the Company to make the milestone payment in installments with the remaining amount payable to Pfizer (including interest) to be made in September 2021 for approximately $21.9 million. Unpaid portions of the milestone payment will accrue interest at 6.25% per annum until paid. The installment payments and accrued interest are included in accrued in-licensed rights . The Company may trigger additional milestone payments in the future. Should the Company commercialize any more of the compounds licensed from Pfizer or any products containing any of these compounds, the Company will be obligated to pay to Pfizer annual royalties at a fixed rate in the low-to-mid teens of net sales of all such products, subject to certain reductions and offsets in some circumstances. The Company’s royalty obligation continues, on a product-by-product and country-by-country basis, until the later of (1) the last to expire licensed patent covering the applicable licensed product in such country, or (2) the earlier of generic competition for such licensed product reaching a certain level in such country or expiration of a certain time period after first commercial sale of such licensed product in such country. In the event that the Company sublicenses the rights granted to the Company under the license agreement with Pfizer to a third party, the same milestone and royalty payments are required. The Company can terminate the license agreement at will, or for safety concerns, in each case upon specified advance notice. Legal Proceedings The Company and certain of its executive officers were named as defendants in the lawsuits detailed in Part II Item 1. “Legal Proceedings” of this Quarterly Report. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | 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 | 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 | Use of Estimates: The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles, or GAAP, requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of revenues and expenses for the period presented. Accordingly, actual results could differ from those estimates. Significant estimates include estimates for variable consideration for which reserves were established. These estimates are included in the calculation of net revenues and include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products. |
Net Income (Loss) per Share of Common Stock | Net Income (Loss) per Share of Common Stock: Basic net income (loss) per share of common stock is computed by dividing net income (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, or ASC, 260, Earnings per Share For the three months ended March 31, 2020, potentially dilutive securities excluded from the calculations were shares issuable upon exercise of options, shares issuable upon exercise of a warrant, and shares underlying RSUs that were subject to vesting and were antidilutive A reconciliation of the numerators and denominators of the basic and diluted net income (loss) per share of common stock computations is as follows (in thousands, except per share amounts): For the Three Months Ended March 31, 2021 2020 Numerator: Net income (loss) $ 16,528 $ (16,933 ) Denominator: Weighted average common stock outstanding for basic net income (loss) per share 40,261 39,291 Net effect of dilutive common stock equivalents 634 — Weighted average common stock outstanding for diluted net income (loss) per share 40,895 39,291 Net income (loss) per share of common stock Basic $ 0.41 $ (0.43 ) Diluted $ 0.40 $ (0.43 ) |
Revenue Recognition | Revenue Recognition: Under ASC Topic 606, Revenue from Contracts with Customers 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 and 68 days 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 year or less. However, no such costs were incurred during the three months ended March 31, 2021 and 2020. Reserves for Variable Consideration: Revenue from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the related sales, and are classified as reductions of accounts receivable, net when the right of offset exists in accordance with ASU 2013-1, Balance Sheet (Topic 210): Clarifying the Scope of Disclosures about Offsetting Assets and Liabilities, The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a significant reversal of revenue would not be probable to occur in a future period for the estimates detailed below as of March 31, 2021 and, therefore, the transaction price was not reduced further during the quarter ended March 31, 2021. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. 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 distinct from the Company’s sale of products to its customers and, therefore, these payments have been recorded as a reduction of revenue within the statements of operations. 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 be returned by its customers and records this estimate as a reduction of product revenue, net in the period the related product revenue is recognized, as well as a reduction to accounts receivable, net on the consolidated balance sheets. The Company currently estimates product returns using its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has an insignificant amount of returns to date and believes that returns of its products will continue to be minimal. 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 yet issued a payment 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 been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimates of future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel at the end of each reporting period. 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. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. The Company evaluates these agreements under ASC 606 to determine the distinct performance obligations. Non-refundable, upfront fees that are not contingent on any future performance and require no consequential continuing involvement by the Company, are recognized as revenue when the license term commences and the licensed data, technology or product is delivered. The Company defers recognition of non-refundable upfront license fees if the performance obligations are not satisfied. 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 occur and when the uncertainty associated with the variable consideration is subsequently resolved. 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, the Company has entered into sub-license agreements with certain sub-licensees in territories outside of the United States. These sub-licensing agreements grant certain intellectual property rights and set forth various respective obligations with respect to actions such as development, pursuit and maintenance of regulatory approvals, commercialization and supply of NERLYNX in the sub-licensees’ respective territories. License fees under the sub-license agreements include one-time upfront payments when each sub-license agreement was executed and potential additional one-time milestone payments due to the Company upon successful completion of certain performance obligations, such as achieving regulatory approvals or sales target thresholds, and potential double-digit royalties on sales of the licensed product, calculated as a percentage of net sales of the licensed product throughout each sub-licensee’s respective territory. During the first quarter of 2021, the Company entered into an amendment to an existing sub-license agreement granting the sub-licensee development, manufacturing and commercial rights to NERLYNX in greater China. Pursuant to the amendment, the Company received and recognized as license revenue an upfront payment of $50.0 million during the first quarter of 2021. The beginning balance of accounts receivable, net on the Company’s consolidated balance sheet for license revenue from the sub-license agreements for the three months ended March 31, 2021 was $2.5 million. As of March 31, 2021, $2.0 million in license revenue from the sub-license agreements is included in accounts receivable, net and $1.0 million in the allowance for credit loss on the consolidated balance sheet Royalty Revenue: For sub-license agreements that are within the scope of ASC 606, the Company recognizes revenue when the related sales occur in accordance with the sales-based royalty exception under ASC 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 $2.4 million for the three months ended March 31, 2021. |
Legal Contingencies and Expense | 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 13-Commitments and Contingencies). |
Royalties Expenses | Royalty Expenses: Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 13 — |
Research and Development Expenses | Research and Development Expenses: Research and development expenses, or 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-party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs. Clinical trial expenses include, but are not limited to, investigator fees, site costs, comparator drug costs, and clinical research organization, or CRO, costs. In the normal course of business, the Company contracts with third parties to perform various clinical trial activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variations from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients and the completion of portions of the clinical trial or similar conditions. The Company’s accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs. As actual costs become known, the Company adjusts its accruals in that period. In instances where the Company enters into agreements with third parties for clinical trials and other consulting activities, upfront amounts are recorded to prepaid expenses and other in the accompanying consolidated balance sheets and expensed as services are performed or as the underlying goods are delivered. If the Company does not expect the services to be rendered or goods to be delivered, any remaining capitalized amounts for non-refundable upfront payments are charged to expense immediately. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. 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. |
Stock-Based Compensation | Stock-Based Compensation: Stock Option Awards : ASC Topic 718, Compensation-Stock Compensation 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 (refer to Note 11 for further details) granted to employees and nonemployees are normally valued at the fair value of the instrument on the grant date and are recognized in the statement of operations over the requisite service period. When the requisite service period precedes the grant date and a market condition exists in the warrant, the Company values the warrant using the Monte Carlo Simulation Method. When the terms of the warrant become fixed, the Company values the warrant using the Black-Scholes Option Pricing Method. As allowed by ASC 718, the Company’s estimate of expected volatility is based on its average volatilities using its publicly traded history. The risk-free rate for periods within the contractual life of the warrant is based on the U.S. Treasury yield curve in effect at the time of grant valuation. In determining the value of the warrant until the terms are fixed, the Company factors in the probability of the market condition occurring and several possible scenarios. When the requisite service period precedes the grant date and is deemed to be complete, the Company records the fair value of the warrant at the time of issuance as an equity stock-based compensation transaction. The grant date is determined when all pertinent information, such as exercise price and quantity are known. |
Income Taxes | Income Taxes: The Company follows ASC Topic 740, Income Taxes 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, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position should be measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. ASC 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. As of March 31, 2021, the Company’s uncertain tax position reserves include a reserve for its R&D credits. |
Financial Instruments | 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 | Cash and Cash Equivalents: The Company classifies all highly liquid instruments with an original maturity of three months or less as cash equivalents. |
Restricted Cash | Restricted Cash: Restricted cash represents cash held at financial institutions that is pledged as collateral for stand-by letters of credit for lease and legal verdict commitments. The lease-related letters of credit will lapse at the end of the respective lease terms through 2026. At March 31, 2021 |
Investment Securities | Investment Securities: The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities may be required prior to maturity to implement management’s strategies. These securities are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. In accordance with ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Assets Measured at Fair Value on a Recurring Basis | Assets Measured at Fair Value on a Recurring Basis: ASC Topic 820, Fair Value Measurement Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs are observable in active markets. Level 3: Valuations derived from valuation techniques in which one or more significant inputs are unobservable. Following are the major categories of assets measured at fair value on a recurring basis as of March 31, 2021 and December 31, 2020, using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3) (in thousands): March 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents $ 66,424 $ — $ — $ 66,424 Commercial paper — 11,093 — 11,093 Corporate bonds — 2,304 — 2,304 Totals $ 66,424 $ 13,397 $ — $ 79,821 December 31, 2020 Level 1 Level 2 Level 3 Total Cash equivalents $ 59,919 $ 11,798 $ — $ 71,717 Commercial paper — 8,096 — 8,096 Totals $ 59,919 $ 19,894 $ — $ 79,813 The Company’s investments in commercial paper, corporate bonds and U.S. government securities are exposed to price fluctuations. The fair value measurements for commercial paper, corporate bonds and U.S. government securities are based upon the quoted prices of similar items in active markets multiplied by the number of securities owned. The following tables summarize the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Estimated March 31, 2021 (in years) cost Gains Losses fair value Cash equivalents $ 66,424 $ — $ — $ 66,424 Commercial paper Less than 1 11,093 — — 11,093 Corporate bonds Less than 1 2,304 — — 2,304 Totals $ 79,821 $ — $ — $ 79,821 Maturity Amortized Unrealized Estimated December 31, 2020 (in years) cost Gains Losses fair value Cash equivalents $ 71,717 $ — $ — $ 71,717 Commercial paper Less than 1 8,096 — — 8,096 Totals Less than 1 $ 79,813 $ — $ — $ 79,813 |
Concentration of Risk | 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, 2021, were approximately $107.6 million. The Company does not believe it is exposed to any significant credit risk due to the quality nature of the financial instruments in which the money is held. Pursuant to the Company’s internal investment policy, investments must be rated A-1/P-1 or better by Standard and Poor’s Rating Service and Moody’s Investors Service at the time of purchase. 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 recorded $0 and $1.0 million as an allowance for credit loss for the periods ended March 31, 2021 and December 31, 2020, respectively. 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 parties to formulate and manufacture NERLYNX and its drug candidates. The commercialization of NERLYNX and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company has no experience in drug formulation or manufacturing and does not intend to establish its own manufacturing facilities. The Company lacks the resources and expertise to formulate or manufacture NERLYNX and other drug candidates. While the drug candidates were being developed by Pfizer, both the drug substance and drug product were manufactured by third-party contractors. The Company is using the same third-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and the commercialization of NERLYNX. If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on one or more third-party contractors to manufacture the commercial supply of drugs. |
Inventory | 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-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within the cost of sales in the consolidated statements of operations. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of sales in the consolidated statements of operations. 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, 2021, the Company’s inventory balance consisted primarily of raw materials purchased subsequent to FDA approval of NERLYNX. |
Property and Equipment, Net | 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 years for computer hardware and software, three years for phone equipment, and seven years for furniture and fixtures. Leasehold improvements are amortized using the straight-line method over the lesser of the useful life or the lease term. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred 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 be recoverable, as required by ASC Topic 360, Property, Plant, and Equipment, or ASC 360 . |
Leases | Leases: ASC Topic 842, Leases 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. 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. 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 continues to be presented as a single lease cost. If a lease is planned to be abandoned with no intention of subleasing, the ROU asset should be assessed for impairment. 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 6 — 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 include options to purchase the leased property. The depreciable life of assets and leasehold improvements is limited by the expected lease term. Covenants imposed by the leases include letters of credit required to be obtained by the lessee. The incremental borrowing rate, or 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 provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The Company’s average IBR for existing leases as of March 31, 2021 is 10.9%. |
License Fees and Intangible Assets | 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 alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. The Company capitalizes technology licenses upon reaching technological feasibility. The Company maintains definite-lived intangible assets related to the license agreement with Pfizer. These assets are amortized over their remaining useful lives, which are estimated based on the shorter of the remaining patent life or the estimated useful life of the underlying product. Intangible assets are amortized using the economic consumption method if anticipated future revenues can be reasonably estimated. The straight-line method is used when future revenues cannot be reasonably estimated. Amortization costs are recorded as part of cost of sales. The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the receipt of additional clinical or nonclinical data regarding one of the Company’s drug candidates or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information regarding potential sales for the drug. If impairment indicators are present or changes in circumstance suggest that impairment may exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. In connection with the FDA approval of NERLYNX in July 2017, the Company triggered a one-time milestone payment pursuant to its license agreement with Pfizer. In June 2020, the Company entered into a letter agreement with Pfizer relating to the method of payment associated with a milestone payment under the Company’s license agreement with Pfizer (see Note 13-Commitments and Contingencies). The Company capitalized the milestones as intangible assets and is amortizing the assets to cost of sales on a straight-line basis over the estimated useful life of the licensed patent through 2030. The Company recorded amortization expense related to its intangible assets of $2.0 million for the three months ended March 31, 2021. As of March 31, 2021 estimated future amortization expense related to the Company’s intangible assets was approximately $6.0 million for the remainder of 2021 and $8.0 million for each year starting 2022 through 2029, and $2.0 million for 2030 During the three months ended March 31, 2021, the Company agreed to settle its ongoing arbitration proceeding with CANbridge BIOMED Limited, or CANbridge, relating to an CANbridge a one-time termination fee of $20.0 million in exchange for it returning to the Company all rights to NERLYNX in greater China. The Company expensed the $20.0 million one-time termination fee to cost of sales in the three months ended March 31, 2021. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards: In December 2019, the FASB issued ASU No 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , as part of its Simplification Initiative to reduce the cost and complexity in accounting for income taxes. The amendments in ASU 2019-12 remove certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 also amends other aspects of the guidance to help simplify and promote consistent application of GAAP. The guidance is effective for interim and annual periods beginning after December 15, 2020, with early adoption permitted. ASU 2019-12 did not have a material effect on the Company’s current financial position, results of operations or financial statement disclosures. In October 2020, the FASB issued ASU 2020 10 Codification Improvements ASU 2020 10 |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Reconciliation of Numerators and Denominators of Basic and Diluted Net Income (Loss) Per Share of Common Stock Computations | A reconciliation of the numerators and denominators of the basic and diluted net income (loss) per share of common stock computations is as follows (in thousands, except per share amounts): For the Three Months Ended March 31, 2021 2020 Numerator: Net income (loss) $ 16,528 $ (16,933 ) Denominator: Weighted average common stock outstanding for basic net income (loss) per share 40,261 39,291 Net effect of dilutive common stock equivalents 634 — Weighted average common stock outstanding for diluted net income (loss) per share 40,895 39,291 Net income (loss) per share of common stock Basic $ 0.41 $ (0.43 ) Diluted $ 0.40 $ (0.43 ) |
Assets Measured at Fair Value on Recurring Basis | Following are the major categories of assets measured at fair value on a recurring basis as of March 31, 2021 and December 31, 2020, using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3) (in thousands): March 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents $ 66,424 $ — $ — $ 66,424 Commercial paper — 11,093 — 11,093 Corporate bonds — 2,304 — 2,304 Totals $ 66,424 $ 13,397 $ — $ 79,821 December 31, 2020 Level 1 Level 2 Level 3 Total Cash equivalents $ 59,919 $ 11,798 $ — $ 71,717 Commercial paper — 8,096 — 8,096 Totals $ 59,919 $ 19,894 $ — $ 79,813 |
Summary of Short-term Investments | The following tables summarize the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Estimated March 31, 2021 (in years) cost Gains Losses fair value Cash equivalents $ 66,424 $ — $ — $ 66,424 Commercial paper Less than 1 11,093 — — 11,093 Corporate bonds Less than 1 2,304 — — 2,304 Totals $ 79,821 $ — $ — $ 79,821 Maturity Amortized Unrealized Estimated December 31, 2020 (in years) cost Gains Losses fair value Cash equivalents $ 71,717 $ — $ — $ 71,717 Commercial paper Less than 1 8,096 — — 8,096 Totals Less than 1 $ 79,813 $ — $ — $ 79,813 |
Accounts Receivable, Net (Table
Accounts Receivable, Net (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounts Receivable Net [Abstract] | |
Schedule of Accounts Receivable, Net | Accounts receivable, net consisted of the following (in thousands): March 31, 2021 December 31, 2020 Trade accounts receivable $ 22,800 $ 21,515 License revenue receivable 2,000 2,500 Royalty revenue receivable 2,358 2,528 Total accounts receivable $ 27,158 $ 26,543 Allowance for credit losses (1,000 ) (1,000 ) Total accounts receivable, net $ 26,158 $ 25,543 |
Schedule of Allowance for Credit Losses | The rollforward of the allowance for credit losses is as follows: Allowance for credit losses (in thousands): Beginning balance at January 1, 2021 $ (1,000 ) Provision for credit loss expense — Accounts receivable written-off — Recoveries — Total ending allowance balance as March 31, 2021 $ (1,000 ) |
Prepaid Expenses and Other (Tab
Prepaid Expenses and Other (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Prepaid Expense And Other Assets [Abstract] | |
Components of Prepaid Expenses and Other | Prepaid expenses and other consisted of the following (in thousands): March 31, 2021 December 31, 2020 Current: CRO services $ 1,308 $ 1,550 Other clinical development 3,322 2,718 Insurance 2,733 3,708 Professional fees 1,083 651 Other 3,143 2,635 11,589 11,262 Long-term: CRO services 198 518 Other clinical development 475 437 Other 657 790 1,330 1,745 Totals $ 12,919 $ 13,007 |
Other Current Assets (Tables)
Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Schedule of Other Current Assets | Other current assets consisted of the following (in thousands): March 31, 2021 December 31, 2020 Deposit for manufacturing costs $ — $ 3,376 Deferred rent 198 198 Other 175 67 Totals $ 373 $ 3,641 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases for the three months ended March 31, 2021: Operating cash flows used for operating leases (in thousands) $ 1,380 Right-of-use assets obtained in exchange for new operating lease liabilities — Weighted average remaining lease term (in years) 5.0 Weighted average discount rate 10.9 % |
Future Minimum Lease Payments Under ASC 842 | The future minimum lease payments under ASC 842 as of March 31, 2021 were as follows (in thousands): Amount 2021 (remaining) 4,054 2022 5,483 2023 5,631 2024 5,805 2025 5,983 Thereafter 1,508 Total minimum lease payments $ 28,464 Less: imputed interest (6,534 ) Total lease liabilities $ 21,930 |
Future Minimum Lease Payments to be Received | The future minimum lease payments to be received as of March 31, 2021 were as follows (in thousands): Amount 2021 (remaining) $ 351 2022 481 2023 495 2024 510 2025 525 Thereafter 134 Total $ 2,496 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands ): March 31, 2021 December 31, 2020 Leasehold improvements $ 3,779 $ 3,779 Computer equipment 2,192 2,192 Telephone equipment 302 302 Furniture and fixtures 2,359 2,359 8,632 8,632 Less: accumulated depreciation (6,349 ) (6,151 ) Totals $ 2,283 $ 2,481 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets, Net | Intangible assets, net consisted of the following (in thousands): March 31, 2021 December 31, 2020 Acquired and in-licensed rights $ 90,000 $ 90,000 Less: accumulated amortization (17,864 ) (15,860 ) Total intangible asset, net $ 72,136 $ 74,140 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following (in thousands): March 31, 2021 December 31, 2020 Current: Accrued legal verdict expense $ 47,731 $ 22,724 Accrued royalties 7,934 8,604 Accrued CRO services 1,795 3,474 Accrued variable consideration 9,050 9,014 Accrued bonus 2,039 7,788 Accrued compensation 5,135 4,820 Accrued other clinical development 1,512 1,904 Accrued professional fees 1,424 1,420 Accrued legal fees 1,599 383 Accrued manufacturing costs 476 752 Other 589 442 79,284 61,325 Long-term: Accrued legal verdict expense — 24,822 Accrued CRO services 934 908 Accrued other 206 233 1,140 25,963 Totals $ 80,424 $ 87,288 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long Term Debt | Long term debt consisted of the following (in thousands): March 31, 2021 Maturity Date Total debt $ 100,000 June 1, 2024 Accretion of final interest payment 3,675 Less: current portion of long-term debt (22,857 ) Less: deferred financing costs (4,472 ) Total long-term debt, net $ 76,346 |
Future Minimum Principal Payments Under New Credit Facility | The future minimum principal payments under the New Credit Facility as of March 31, 2021 were as follows (in thousands): Amount 2021 (remaining) $ 14,286 2022 34,286 2023 34,286 2024 17,142 Thereafter — Total $ 100,000 |
Schedule of Deferred Financing Costs | Deferred financing costs consisted of the following (in thousands): March 31, 2021 December 31, 2020 Deferred financing costs $ 8,668 $ 8,668 Less: accumulated amortization (4,196 ) (3,666 ) Included in long-term debt $ 4,472 $ 5,002 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Fair Value Options Weighted-Average Assumptions | 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. 2021 2020 Dividend yield 0.0 % 0.0 % Expected volatility 86.9 % 102.7 % Risk-free interest rate 0.7 % 1.0 % Expected life in years 5.81 5.80 |
Stock-based Compensation Expense | Stock-based compensation expense was as follows (in thousands): For the Three Months Ended March 31, 2021 2020 Stock-based compensation: Options - Selling, general, and administrative $ 1,007 $ 920 Research and development 228 841 Restricted stock units - Selling, general, and administrative 2,594 3,772 Research and development 2,031 3,374 Total stock-based compensation expense $ 5,860 $ 8,907 |
Activity with Respect to Options Granted | Activity with respect to options granted under the 2011 Plan and 2017 Plan is summarized as follows: Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2020 5,009,342 $ 71.42 5.1 $ 3,458 Granted 442,027 $ 12.02 9.9 Expired (33,729 ) $ 77.55 Outstanding at March 31, 2021 5,417,640 $ 66.53 5.2 $ 2,993 Nonvested at March 31, 2021 1,085,182 $ 11.26 9.3 $ 626 Exercisable 4,332,458 $ 80.38 4.2 $ 2,367 |
Stock Options | Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2020 899,672 $ 8.71 Granted 442,027 8.54 Vested/Issued (256,517 ) 9.66 Nonvested shares at March 31, 2021 1,085,182 $ 8.42 |
Restricted Stock Units | Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2020 1,854,205 $ 13.51 Granted 999,272 12.30 Vested/Issued (237,876 ) 17.60 Forfeited (88,898 ) 13.62 Nonvested shares at March 31, 2021 2,526,703 $ 12.65 |
Business and Basis of Present_2
Business and Basis of Presentation - Additional Information (Detail) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2021USD ($)Subsidiary | Mar. 31, 2020USD ($) | Dec. 31, 2020USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||
Number of subsidiaries | Subsidiary | 2 | ||
Net income (loss) | $ 16,528 | $ (16,933) | |
Net cash used in operating activities | 15,661 | $ (11,540) | |
Cash and cash equivalents | 95,653 | $ 85,293 | |
Marketable securities | $ 13,397 | $ 8,096 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2021USD ($)Segment$ / sharesshares | Mar. 31, 2020USD ($)shares | Dec. 31, 2020USD ($) | Jan. 01, 2021 | |
Significant Accounting Policies [Line Items] | ||||
Number of segments | Segment | 1 | |||
Incremental costs expenses | $ 0 | $ 0 | ||
Revenue recognized | 98,169,000 | 51,217,000 | ||
Restricted cash | 12,200,000 | $ 12,200,000 | ||
Cash and cash equivalents and restricted cash in excess of insured limits | 107,600,000 | |||
Allowance for doubtful accounts | $ 0 | $ 1,000,000 | ||
Lessee, operating lease, existence of option to extend | true | |||
Lessee, operating lease, option to extend, description | Options to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. | |||
Lessee, operating lease, existence of option to terminate | true | |||
Lessee, operating lease, option to terminate, description | Options to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. | |||
Average incremental borrowing rate | 10.90% | |||
Amortization expenses related to intangible assets | $ 2,000,000 | |||
Estimated future amortization expense related to intangible assets, remainder of 2021 | 6,000,000 | |||
Estimated future amortization expense related to intangible assets, 2022 | 8,000,000 | |||
Estimated future amortization expense related to intangible assets, 2023 | 8,000,000 | |||
Estimated future amortization expense related to intangible assets, 2024 | 8,000,000 | |||
Estimated future amortization expense related to intangible assets, 2025 | 8,000,000 | |||
Estimated future amortization expense related to intangible assets, 2026 | 8,000,000 | |||
Estimated future amortization expense related to intangible assets, 2027 | 8,000,000 | |||
Estimated future amortization expense related to intangible assets, 2028 | 8,000,000 | |||
Estimated future amortization expense related to intangible assets, 2029 | 8,000,000 | |||
Estimated future amortization expense related to intangible assets, 2030 | $ 2,000,000 | |||
ASU 2019-12 | ||||
Significant Accounting Policies [Line Items] | ||||
Change in Accounting Principle, Accounting Standards Update, Early Adoption [true false] | true | |||
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false] | true | |||
ASU 2020-10 | ||||
Significant Accounting Policies [Line Items] | ||||
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false] | true | |||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | |||
Computer Hardware and Software | ||||
Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 3 years | |||
Phone Equipment | ||||
Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 3 years | |||
Furniture and Fixtures | ||||
Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 7 years | |||
Letter of Credit | ||||
Significant Accounting Policies [Line Items] | ||||
Lease expiration year | 2026 | |||
Sub-license Agreements | ||||
Significant Accounting Policies [Line Items] | ||||
Potential milestone payments receivable | $ 581,600,000 | |||
CANbridge Termination of Sub-License Agreement | CANbridge Life Sciences | ||||
Significant Accounting Policies [Line Items] | ||||
One-time termination fee expense | $ 20,000,000 | |||
Cost, Product and Service [Extensible List] | Cost of sales | |||
One-time termination fee | $ 20,000,000 | |||
License Revenue | ||||
Significant Accounting Policies [Line Items] | ||||
Revenue recognized from beginning balance | 2,500,000 | |||
Revenue recognized | 50,000,000 | 2,000,000 | ||
License Revenue | Sub-license Agreements | ||||
Significant Accounting Policies [Line Items] | ||||
Upfront payment received | 50,000,000 | |||
License Revenue | Accounts Receivable, Net | Sub-license Agreements | ||||
Significant Accounting Policies [Line Items] | ||||
Revenue recognized | 2,000,000 | |||
License Revenue | Allowance for Credit Loss | Sub-license Agreements | ||||
Significant Accounting Policies [Line Items] | ||||
Revenue recognized | 1,000,000 | |||
Royalty Revenue | ||||
Significant Accounting Policies [Line Items] | ||||
Revenue recognized | $ 2,353,000 | $ 608,000 | ||
Minimum | ||||
Significant Accounting Policies [Line Items] | ||||
Revenue recognition, payment terms | 10 days | |||
Maximum | ||||
Significant Accounting Policies [Line Items] | ||||
Revenue recognition, payment terms | 68 days | |||
Amortization period recognized | 1 year | |||
Common Stock | ||||
Significant Accounting Policies [Line Items] | ||||
Shares of common stock that could be acquired by warrant | shares | 2,116,250 | |||
Common stock price | $ / shares | $ 16 | |||
Employee Stock Option | ||||
Significant Accounting Policies [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted earnings per share | shares | 4,960,445 | 4,330,242 | ||
Warrants | ||||
Significant Accounting Policies [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted earnings per share | shares | 2,116,250 | 2,116,250 | ||
Restricted Stock Units | ||||
Significant Accounting Policies [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted earnings per share | shares | 1,741,770 | 2,274,100 |
Summary of Reconciliation of Nu
Summary of Reconciliation of Numerators and Denominators of Basic and Diluted Net Income (Loss) Per Share of Common Stock Computations (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Numerator: | ||
Net income (loss) | $ 16,528 | $ (16,933) |
Denominator: | ||
Weighted-average shares of common stock outstanding—basic | 40,260,864 | 39,291,162 |
Net effect of dilutive common stock equivalents | 634,000 | |
Weighted average common stock outstanding for diluted net income (loss) per share | 40,894,868 | 39,291,162 |
Net income (loss) per share of common stock | ||
Net income (loss) per share of common stock—basic | $ 0.41 | $ (0.43) |
Net income (loss) per share of common stock—diluted | $ 0.40 | $ (0.43) |
Assets Measured at Fair Value o
Assets Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 66,424 | $ 71,717 |
Totals | 79,821 | 79,813 |
Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 11,093 | 8,096 |
Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 2,304 | |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 66,424 | 59,919 |
Totals | 66,424 | 59,919 |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 11,798 | |
Totals | 13,397 | 19,894 |
Level 2 | Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 11,093 | $ 8,096 |
Level 2 | Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 2,304 |
Summary of Short-term Investmen
Summary of Short-term Investments (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, Maturity (in years) | Less than 1 | |
Marketable securities, Amortized cost | $ 79,821 | $ 79,813 |
Marketable securities, Estimated fair value | 79,821 | 79,813 |
Cash equivalents, Amortized cost | 95,653 | 85,293 |
Cash Equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cash equivalents, Amortized cost | 66,424 | 71,717 |
Cash equivalents, Estimated fair value | $ 66,424 | $ 71,717 |
Commercial paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, Maturity (in years) | Less than 1 | Less than 1 |
Marketable securities, Amortized cost | $ 11,093 | $ 8,096 |
Marketable securities, Estimated fair value | $ 11,093 | $ 8,096 |
Corporate bonds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, Maturity (in years) | Less than 1 | |
Marketable securities, Amortized cost | $ 2,304 | |
Marketable securities, Estimated fair value | $ 2,304 |
Accounts Receivable, Net - Sche
Accounts Receivable, Net - Schedule of Accounts Receivable, Net (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Accounts Receivable Net [Abstract] | ||
Trade accounts receivable | $ 22,800 | $ 21,515 |
License revenue receivable | 2,000 | 2,500 |
Royalty revenue receivable | 2,358 | 2,528 |
Total accounts receivable | 27,158 | 26,543 |
Allowance for credit losses | (1,000) | (1,000) |
Total accounts receivable, net | $ 26,158 | $ 25,543 |
Accounts Receivable, Net - Addi
Accounts Receivable, Net - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Accounts Receivable Net [Abstract] | ||
Allowance for doubtful accounts | $ 0 | $ 1 |
Accounts Receivable, Net - Sc_2
Accounts Receivable, Net - Schedule of Allowance for Credit Losses (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Accounts Receivable Net [Abstract] | ||
Allowance for credit losses, Beginning balance | $ (1,000) | |
Provision for credit loss expense | 0 | $ (1,000) |
Allowance for credit losses, Ending balance | $ (1,000) | $ (1,000) |
Components of Prepaid Expenses
Components of Prepaid Expenses and Other (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | $ 11,589 | $ 11,262 |
Prepaid expenses and other, long-term | 1,330 | 1,745 |
Totals | 12,919 | 13,007 |
CRO services | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 1,308 | 1,550 |
Prepaid expenses and other, long-term | 198 | 518 |
Other clinical development | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 3,322 | 2,718 |
Prepaid expenses and other, long-term | 475 | 437 |
Insurance | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 2,733 | 3,708 |
Professional fees | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 1,083 | 651 |
Other | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 3,143 | 2,635 |
Prepaid expenses and other, long-term | $ 657 | $ 790 |
Schedule of Other Current Asset
Schedule of Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Deposit for manufacturing costs | $ 3,376 | |
Deferred rent | $ 198 | 198 |
Other | 175 | 67 |
Totals | $ 373 | $ 3,641 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Millions | 1 Months Ended | 3 Months Ended | |||
Feb. 28, 2019ft² | Jun. 30, 2012ft² | Dec. 31, 2011ft² | Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) | |
Leases [Line Items] | |||||
Lessee, operating lease, existence of option to extend | true | ||||
Fixed lease expense | $ 1.2 | $ 1.2 | |||
Variable lease expense | 0.1 | $ 0.1 | |||
Operating sublease income | 0.1 | ||||
Los Angeles, California | |||||
Leases [Line Items] | |||||
Percentage of increase in annual rent | 3.00% | ||||
Existing square feet of subleased property | ft² | 12,429 | ||||
Sublease expiration month and year | 2026-03 | ||||
Lease Agreement executed on December 2011 | |||||
Leases [Line Items] | |||||
Office lease, lease term | 7 years | ||||
Existing square feet of leased property | ft² | 65,656 | ||||
Percentage of increase in annual rent | 3.00% | ||||
Office space, lease extension Stand-by letter of credit | 2 | ||||
Lease expiration month and year | 2026-03 | ||||
Lease Agreement executed on June 2012 | |||||
Leases [Line Items] | |||||
Existing square feet of leased property | ft² | 29,470 | ||||
Percentage of increase in annual rent | 3.00% | ||||
Office space, lease extension Stand-by letter of credit | $ 1.1 | ||||
Lease expiration month and year | 2026-03 | ||||
Lessee, operating lease, existence of option to extend | true | ||||
Lease option to extend, term | 5 years |
Supplemental Cash Flow Informat
Supplemental Cash Flow Information Related to Leases (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Leases [Abstract] | |
Operating cash flows used for operating leases (in thousands) | $ 1,380 |
Weighted average remaining lease term (in years) | 5 years |
Weighted average discount rate | 10.90% |
Future Minimum Lease Payments U
Future Minimum Lease Payments Under ASC 842 (Detail) $ in Thousands | Mar. 31, 2021USD ($) |
Leases [Abstract] | |
2021 (remaining) | $ 4,054 |
2022 | 5,483 |
2023 | 5,631 |
2024 | 5,805 |
2025 | 5,983 |
Thereafter | 1,508 |
Total minimum lease payments | 28,464 |
Less: imputed interest | (6,534) |
Total lease liabilities | $ 21,930 |
Future Minimum Lease Payments t
Future Minimum Lease Payments to be Received (Detail) $ in Thousands | Mar. 31, 2021USD ($) |
Leases [Abstract] | |
2021 (remaining) | $ 351 |
2022 | 481 |
2023 | 495 |
2024 | 510 |
2025 | 525 |
Thereafter | 134 |
Total | $ 2,496 |
Property and Equipment, Net (De
Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 8,632 | $ 8,632 |
Less: accumulated depreciation | (6,349) | (6,151) |
Totals | 2,283 | 2,481 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 3,779 | 3,779 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 2,192 | 2,192 |
Telephone Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 302 | 302 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 2,359 | $ 2,359 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Property Plant And Equipment [Abstract] | |
Depreciation expense | $ 0.2 |
Schedule of Intangible Assets,
Schedule of Intangible Assets, Net (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Goodwill And Intangible Assets Disclosure [Abstract] | ||
Acquired and in-licensed rights | $ 90,000 | $ 90,000 |
Less: accumulated amortization | (17,864) | (15,860) |
Total intangible asset, net | $ 72,136 | $ 74,140 |
Intangible Assets, Net - Additi
Intangible Assets, Net - Additional Information (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Amortization expense | $ 2 |
Estimated remaining useful life of intangible assets | 9 years |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current: | ||
Accrued legal verdict expense | $ 47,731 | $ 22,724 |
Accrued royalties | 7,934 | 8,604 |
Accrued CRO services | 1,795 | 3,474 |
Accrued variable consideration | 9,050 | 9,014 |
Accrued bonus | 2,039 | 7,788 |
Accrued compensation | 5,135 | 4,820 |
Accrued other clinical development | 1,512 | 1,904 |
Accrued professional fees | 1,424 | 1,420 |
Accrued legal fees | 1,599 | 383 |
Accrued manufacturing costs | 476 | 752 |
Other | 589 | 442 |
Accrued expenses, current | 79,284 | 61,325 |
Long-term: | ||
Accrued legal verdict expense | 24,822 | |
Accrued CRO services | 934 | 908 |
Accrued other | 206 | 233 |
Accrued expenses, long-term | 1,140 | 25,963 |
Totals | $ 80,424 | $ 87,288 |
Accrued Expenses - Additional I
Accrued Expenses - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Accrued Expenses [Line Items] | ||
Current accrued legal verdict expense, estimate owed | $ 47,731,000 | $ 22,724,000 |
Accrued legal verdict expense | $ 24,822,000 | |
Eshelman v. Puma Biotechnology, Inc. | ||
Accrued Expenses [Line Items] | ||
Current accrued legal verdict expense, estimate owed | 22,900,000 | |
Eshelman v. Puma Biotechnology, Inc. | Maximum | ||
Accrued Expenses [Line Items] | ||
Claimed damages amount | 27,900,000 | |
Hsu v. Puma Biotechnology, Inc. | ||
Accrued Expenses [Line Items] | ||
Claimed damages amount | 50,500,000 | |
Accrued legal verdict expense | 24,900,000 | |
Accrued estimated losses | $ 24,900,000 |
Debt - Schedule of Long Term De
Debt - Schedule of Long Term Debt (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Debt Disclosure [Abstract] | ||
Total debt | $ 100,000 | |
Accretion of final interest payment | 3,675 | |
Less: current portion of long-term debt | (22,857) | $ (14,286) |
Less: deferred financing costs | (4,472) | $ (5,002) |
Total long-term debt, net | $ 76,346 | |
Total debt, maturity date | Jun. 1, 2024 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) | Jun. 28, 2019 | Mar. 31, 2021 | Mar. 31, 2020 |
Debt Instrument [Line Items] | |||
Interest expense related to amortization of debt issuance costs | $ 500,000 | $ 500,000 | |
Oxford | Secured Promissory Notes | |||
Debt Instrument [Line Items] | |||
Term loan, maximum borrowing capacity | $ 100,000,000 | ||
Aggregate principal amount | 100,000,000 | ||
Additional money remains available under new credit facility | $ 0 | ||
Percentage of issued and outstanding capital stock of its subsidiary pledged | 65.00% | ||
Interest rate, description | The term loans under the New Credit Facility bear interest at an annual rate equal to the greater of (i) 9.0% and (ii) the sum of (a) the “prime rate,” as reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 3.5%. The Company is required to make monthly interest-only payments on each term loan under the New Credit Facility commencing on the first calendar day of the calendar month following the funding date of such term loan, and continuing on the first calendar day of each calendar month thereafter through August 1, 2021, or the Amortization Date. | ||
Annual interest rate | 9.00% | ||
Effective interest rate | 12.75% | ||
Redemption period start date | Aug. 1, 2021 | ||
Line of credit facility closing date | Jun. 1, 2024 | ||
Percentage of original principal amount payable in final payment | 7.50% | ||
Percentage of additional interest rate to be charged on the event of default | 5.00% | ||
Amount of indebtedness or judgments against company to be considered as threshold limit for default | $ 500,000 | ||
Term loans outstanding | $ 100,000,000 | ||
Oxford | Secured Promissory Notes | First Anniversary of Funding | |||
Debt Instrument [Line Items] | |||
Prepayment fee, percentage | 3.00% | ||
Oxford | Secured Promissory Notes | Between First Anniversary and Second Anniversary | |||
Debt Instrument [Line Items] | |||
Prepayment fee, percentage | 2.00% | ||
Oxford | Secured Promissory Notes | After Second Anniversary and Prior to Maturity Date | |||
Debt Instrument [Line Items] | |||
Prepayment fee, percentage | 1.00% | ||
Oxford | Secured Promissory Notes | Prime Rate | |||
Debt Instrument [Line Items] | |||
Basis spread on variable rate | 3.50% |
Debt - Future Minimum Principal
Debt - Future Minimum Principal Payments Under New Credit Facility (Detail) $ in Thousands | Mar. 31, 2021USD ($) |
Debt Instrument [Line Items] | |
Total long-term debt, net | $ 76,346 |
Secured Promissory Notes | |
Debt Instrument [Line Items] | |
2021 (remaining) | 14,286 |
2022 | 34,286 |
2023 | 34,286 |
2024 | 17,142 |
Total long-term debt, net | $ 100,000 |
Debt - Schedule of Deferred Fin
Debt - Schedule of Deferred Financing Costs (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Deferred financing costs | $ 8,668 | $ 8,668 |
Less: accumulated amortization | (4,196) | (3,666) |
Included in long-term debt | $ 4,472 | $ 5,002 |
Stockholders Equity - Additiona
Stockholders Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Oct. 31, 2011 | |
Stockholders Equity Note [Line Items] | ||||
Common stock issued upon vesting of RSUs | 237,876 | 113,417 | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 | ||
Common stock, par value | $ 0.0001 | $ 0.0001 | ||
Warrant expiration date | Oct. 4, 2021 | |||
Issuance of common stock on exercise of option | 5,417,640 | 5,009,342 | ||
Weighted-average grant date fair value of options granted | $ 8.54 | $ 7.86 | ||
Non Vested Stock Options | ||||
Stockholders Equity Note [Line Items] | ||||
Estimated unrecognized employee compensation cost related to non-vested stock options granted | $ 8.4 | |||
Estimated unrecognized employee compensation cost related to non-vested stock options granted, Weighted-average period of recognition | 2 years 1 month 6 days | |||
Restricted Stock Units | ||||
Stockholders Equity Note [Line Items] | ||||
Common stock issued upon vesting of RSUs | 237,876 | |||
Issuance of common stock on exercise of vesting of RSUs granted | 999,272 | |||
Estimated unrecognized employee compensation cost related to non-vested stock options granted | $ 22.3 | |||
Estimated unrecognized employee compensation cost related to non-vested stock options granted, Weighted-average period of recognition | 2 years | |||
Weighted-average grant date fair value of RSUs | $ 12.30 | $ 10.74 | ||
2011 Plan | ||||
Stockholders Equity Note [Line Items] | ||||
Common stock shares reserved for issuance | 12,529,412 | |||
Stock options, award vesting period | 3 years | |||
Issuance of common stock on exercise of option | 6,771,081 | |||
Issuance of common stock on exercise of vesting of RSUs granted | 6,771,081 | |||
Common stock shares available for future issuance | 1,051,438 | |||
2017 Employment Inducement Incentive Award Plan | ||||
Stockholders Equity Note [Line Items] | ||||
Common stock shares reserved for issuance | 2,000,000 | |||
Stock options, award vesting period | 3 years | |||
Issuance of common stock on exercise of option | 1,173,262 | |||
Issuance of common stock on exercise of vesting of RSUs granted | 1,173,262 | |||
Common stock shares available for future issuance | 452,353 | |||
Maximum | 2011 Plan | ||||
Stockholders Equity Note [Line Items] | ||||
Stock options granted, term | 10 years | |||
Maximum | 2017 Employment Inducement Incentive Award Plan | ||||
Stockholders Equity Note [Line Items] | ||||
Stock options granted, term | 10 years | |||
Common Stock | ||||
Stockholders Equity Note [Line Items] | ||||
Issuance of common stock on exercise of option | 0 | 500 | ||
Shares of common stock that could be acquired by warrant | 2,116,250 | |||
Common stock price | $ 16 | |||
Common Stock | Alan Auerbach | Minimum | ||||
Stockholders Equity Note [Line Items] | ||||
Minimum ownership percentage of outstanding shares of common stock the president need to maintain after issuance of warrants | 20.00% |
Stockholders Equity - Fair Valu
Stockholders Equity - Fair Value Options Weighted-Average Assumptions (Detail) - Employee and Nonemployee Stock Option | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility | 86.90% | 102.70% |
Risk-free interest rate | 0.70% | 1.00% |
Expected life in years | 5 years 9 months 21 days | 5 years 9 months 18 days |
Stockholders Equity - Stock-bas
Stockholders Equity - Stock-based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 5,860 | $ 8,907 |
Employee Stock Option | Selling, general and administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | 1,007 | 920 |
Employee Stock Option | Research and development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | 228 | 841 |
Restricted Stock Units | Selling, general and administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | 2,594 | 3,772 |
Restricted Stock Units | Research and development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 2,031 | $ 3,374 |
Stockholders Equity - Activity
Stockholders Equity - Activity with Respect to Options Granted (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Shares | ||
Beginning balance, shares | 5,009,342 | |
Granted, shares | 442,027 | |
Expired, shares | (33,729) | |
Ending balance, shares | 5,417,640 | 5,009,342 |
Nonvested, shares | 1,085,182 | 899,672 |
Exercisable, shares | 4,332,458 | |
Weighted Average Exercise Price | ||
Beginning Balance, Weighted Average Exercise Price | $ 71.42 | |
Granted, Weighted Average Exercise Price | 12.02 | |
Expired, Weighted Average Exercise Price | 77.55 | |
Ending Balance, Weighted Average Exercise Price | 66.53 | $ 71.42 |
Nonvested, Weighted Average Exercise Price | 11.26 | |
Exercisable, Weighted Average Exercise Price | $ 80.38 | |
Weighted Average Remaining Contractual Term (years) | ||
Weighted Average Remaining Contractual Term (years) | 5 years 2 months 12 days | 5 years 1 month 6 days |
Granted, Weighted Average Remaining Contractual Term (years) | 9 years 10 months 24 days | |
Nonvested, Weighted Average Remaining Contractual Term (years) | 9 years 3 months 18 days | |
Exercisable, Weighted Average Remaining Contractual Term (years) | 4 years 2 months 12 days | |
Aggregate Intrinsic Value | ||
Shares, Outstanding, Aggregate Intrinsic Value | $ 2,993 | $ 3,458 |
Nonvested, Aggregate Intrinsic Value | 626 | |
Exercisable, Aggregate Intrinsic Value | $ 2,367 |
Stockholders Equity - Stock Opt
Stockholders Equity - Stock Options (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Shares | ||
Nonvested shares, Beginning balance | 899,672 | |
Granted, shares | 442,027 | |
Vested/Issued, shares | (256,517) | |
Nonvested shares, Ending balance | 1,085,182 | |
Weighted Average Grant-Date Fair Value | ||
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value | $ 8.71 | |
Granted, Weighted Average Grant-Date Fair Value | 8.54 | $ 7.86 |
Vested/Issued, Weighted Average Grant-Date Fair Value | 9.66 | |
Nonvested, Ending balance, Weighted Average Grant-Date Fair Value | $ 8.42 |
Stockholders Equity - Restricte
Stockholders Equity - Restricted Stock Units (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Shares | ||
Vested/Issued, shares | (237,876) | (113,417) |
Restricted Stock Units | ||
Shares | ||
Nonvested shares, Beginning balance | 1,854,205 | |
Granted, shares | 999,272 | |
Vested/Issued, shares | (237,876) | |
Forfeited, shares | (88,898) | |
Nonvested shares, Ending balance | 2,526,703 | |
Weighted Average Grant-Date Fair Value | ||
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value | $ 13.51 | |
Granted, Weighted Average Grant-Date Fair Value | 12.30 | $ 10.74 |
Vested/Issued, Weighted Average Grant-Date Fair Value | 17.60 | |
Forfeited, Weighted Average Grant-Date Fair Value | 13.62 | |
Nonvested, Ending balance, Weighted Average Grant-Date Fair Value | $ 12.65 |
401(K) Savings Plan - Additiona
401(K) Savings Plan - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Employer matching contribution expenses | $ 0.6 | $ 0.4 |
First 3% of each Participant's Contributions | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Company's matching contributions to the 401(k)plan | 100.00% | |
Second 2% of each Participant's Contributions | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Company's matching contributions to the 401(k)plan | 50.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended |
Sep. 30, 2021 | Mar. 31, 2021 | |
Commitments And Contingencies Disclosure [Line Items] | ||
License agreement, expected milestone payment | $ 187.5 | |
Percentage of unpaid portion of milestone payments interest rate | 6.25% | |
Forecast | ||
Commitments And Contingencies Disclosure [Line Items] | ||
License agreement, installment milestone payment | $ 21.9 |