Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 01, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
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 | 39,364,379 | |
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, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 83,385 | $ 60,037 |
Marketable securities | 17,170 | 51,607 |
Accounts receivable, net | 31,542 | 28,896 |
Inventory, net | 3,297 | 3,170 |
Prepaid expenses, current | 13,937 | 13,259 |
Deferred rent | 195 | 154 |
Restricted cash, current | 8,850 | 8,850 |
Other current assets | 305 | 323 |
Total current assets | 158,681 | 166,296 |
Lease right-of-use assets, net | 18,016 | 18,522 |
Property and equipment, net | 3,085 | 3,304 |
Intangible assets, net | 39,474 | 40,461 |
Restricted cash, long-term | 3,812 | 4,323 |
Prepaid expenses and other, long-term | 2,461 | 1,999 |
Total assets | 225,529 | 234,905 |
Current liabilities: | ||
Accounts payable | 17,268 | 19,183 |
Accrued expenses | 69,464 | 69,030 |
Post-marketing commitment liability, current | 1,000 | |
Lease liabilities, current | 2,735 | 2,624 |
Total current liabilities | 90,467 | 90,837 |
Lease liabilities, long-term | 21,930 | 22,643 |
Post-marketing commitment liability, long-term | 8,000 | 9,000 |
Long-term debt | 95,755 | 94,962 |
Total liabilities | 216,152 | 217,442 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Common stock - $.0001 par value per share; 100,000,000 shares authorized; 39,317,221 shares issued and outstanding at March 31, 2020 and 39,203,304 issued and outstanding at December 31, 2019 | 4 | 4 |
Additional paid-in capital | 1,303,940 | 1,295,033 |
Accumulated other comprehensive income | 2 | 62 |
Accumulated deficit | (1,294,569) | (1,277,636) |
Total stockholders' equity | 9,377 | 17,463 |
Total liabilities and stockholders' equity | $ 225,529 | $ 234,905 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 39,317,221 | 39,203,304 |
Common stock, shares outstanding | 39,317,221 | 39,203,304 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenue: | ||
Total revenue | $ 51,217 | $ 99,067 |
Operating costs and expenses: | ||
Cost of sales | 9,076 | 7,985 |
Selling, general and administrative | 30,937 | 45,506 |
Research and development | 25,455 | 35,728 |
Total operating costs and expenses | 65,468 | 89,219 |
(Loss) profit from operations | (14,251) | 9,848 |
Other income (expenses): | ||
Interest income | 386 | 872 |
Interest expense | (3,068) | (4,443) |
Legal verdict expense | (93) | (16,350) |
Other income (expenses) | 93 | (14) |
Total other expenses | (2,682) | (19,935) |
Net loss | (16,933) | (10,087) |
Net loss applicable to common stockholders | $ (16,933) | $ (10,087) |
Net loss per share of common stock—basic and diluted | $ (0.43) | $ (0.26) |
Weighted-average shares of common stock outstanding—basic and diluted | 39,291,162 | 38,481,824 |
Product Revenue, Net | ||
Revenue: | ||
Total revenue | $ 48,609 | $ 45,567 |
License Revenue | ||
Revenue: | ||
Total revenue | 2,000 | $ 53,500 |
Royalty Revenue | ||
Revenue: | ||
Total revenue | $ 608 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (16,933) | $ (10,087) |
Other comprehensive loss | ||
Unrealized (loss) gain on available-for-sale securities, net of tax of $0 and $0 | (63) | 32 |
Reclassifications of gain on available-for-sale securities, included in “Other income (expenses)”, net of tax of $0 and $0 | 3 | |
Comprehensive loss | $ (16,993) | $ (10,055) |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Unrealized gain (loss) on available-for-sale securities, tax | $ 0 | $ 0 |
Reclassifications of gain on available-for-sale securities, included in “Other income (expense), net”, tax | $ 0 | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Receivables from Exercises of Options | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2018 | $ 34,306 | $ 4 | $ 1,236,355 | $ (12) | $ (1,202,041) | |
Beginning Balance (in shares) at Dec. 31, 2018 | 38,325,037 | |||||
Stock-based compensation | 18,138 | 18,138 | ||||
Shares issued or restricted stock units vested under employee stock plans | 1,082 | 1,093 | $ (11) | |||
Shares issued or restricted stock units vested under employee stock plans (in shares) | 248,081 | |||||
Unrealized gain (loss) on available-for- sale securities | 32 | 32 | ||||
Net loss | (10,087) | (10,087) | ||||
Ending Balance at Mar. 31, 2019 | 43,471 | $ 4 | 1,255,586 | $ (11) | 20 | (1,212,128) |
Ending Balance (in shares) at Mar. 31, 2019 | 38,573,118 | |||||
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 | 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 gain (loss) on available-for- sale securities | (63) | (63) | ||||
Net 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 | 39,317,221 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating activities: | ||
Net loss | $ (16,933) | $ (10,087) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,916 | 2,135 |
Stock-based compensation | 8,907 | 18,138 |
Disposal of property and equipment | 1 | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (2,646) | (60,211) |
Inventory, net | (127) | (12) |
Prepaid expenses and other | (1,140) | 1,230 |
Other current assets | 18 | (8,368) |
Accounts payable | (1,928) | 8,194 |
Accrued expenses | 434 | 23,850 |
Deferred rent | (41) | |
Post-marketing commitment liability | 9,000 | |
Net cash used in operating activities | (11,540) | (16,130) |
Investing activities: | ||
Purchase of available-for-sale securities | (86,715) | |
Maturity of available-for-sale securities | 34,377 | 42,132 |
Net cash provided by (used in) investing activities | 34,377 | (44,583) |
Financing activities: | ||
Net proceeds from shares issued under employee stock plans | 1,082 | |
Net cash provided by financing activities | 1,082 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | 22,837 | (59,631) |
Cash, cash equivalents and restricted cash, beginning of period | 73,210 | 112,738 |
Cash, cash equivalents and restricted cash, end of period | 96,047 | 53,107 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Property and equipment purchases in accounts payable | 13 | |
Receivables related to stock option exercises | 11 | |
Supplemental disclosure of cash flow information: | ||
Interest paid | $ 2,275 | $ 3,228 |
Business and Basis of Presentat
Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2020 | |
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. 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 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 in-licenses PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357, as well as certain related compounds, 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 numerous regions outside the United States, including Europe (excluding Russia and Ukraine), 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 a net loss of approximately $16.9 million The Company’s Additionally, the terms of the Company’s loan and security agreement place restrictions on the Company’s ability to operate the business and on the Company’s financial flexibility, and the Company may be unable to achieve the revenue necessary to satisfy the minimum revenue covenants. Since its inception through March 31, 2020, 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, 2020 | |
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 Loss per Share of Common Stock: Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the periods presented, as required by Accounting Standards Codification, or ASC, 260, Earnings per Share For the quarter ended March 31, 2019, potentially dilutive securities excluded from the calculations were 5,554,070 shares issuable upon exercise of options, 2,116,250 shares issuable upon exercise of a warrant, and 1,698,146 shares underlying RSUs that were subject to vesting and were antidilutive Revenue Recognition: The Company adopted ASC Topic 606, Revenue from Contracts with Customers To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identifies the contract(s) with a customer, (ii) identifies the performance obligations in the contract, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations in the contract, and (v) recognizes revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net (below). 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 quarter ended March 31, 2020. Product revenue from each of the Company’s customers who individually accounted for 10% or more of total revenues consisted of the following: For the Three Months Ended March 31, 2020 Caremark, LLC 33% Accredo Health Group, Inc. / AcariaHealth, Inc. 21% Biologics, Inc. 11% ASD Healthcare and Oncology Supply 11% For the Three Months Ended March 31, 2019 Caremark, LLC 30% Accredo Health Group, Inc. / AcariaHealth, Inc. 25% Biologics, Inc. 11% Diplomat Pharmacy, Inc. 11% 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 or as a current liability. These estimates take into consideration a range of possible outcomes that are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. 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 material reversal of revenue would not occur in a future period for the estimates detailed below as of March 31, 20 20 and, therefore, the transaction price was not reduced further during the quarter ended March 31, 20 20 . 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 receivables, net on the consolidated balance sheets. In addition, the Company compensates its customers for sales order management, data, and distribution services. The Company has determined such services received to date are not 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 statement 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 receivables, 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 are established in the same period that 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. Pint Agreement During 2018, the Company entered into a sub-license agreement, or the Pint Agreement, with Pint Pharma International SA, or Pint. The Pint Agreement granted intellectual property rights and set forth the respective obligations with respect to development, commercialization and supply of NERLYNX in Mexico and 21 countries and territories in Central and South America, or the Pint Territory. The Pint Agreement met the contract existence criteria and contained distinct, identifiable performance obligations for which the stand-alone selling prices were readily determinable and allocable. The Company is obligated to supply Pint with the licensed product during development pursuant to a supply agreement. This supply arrangement has been identified as a separate performance obligation. To determine the respective stand-alone selling prices, the Company estimated the transaction prices, including any variable consideration, at contract inception and determined the fair value of such obligations based on similar arrangements. When determining the transaction prices, the Company assumed that the goods or services will be transferred to the customer based on the terms of the existing contract and did not take into consideration the possibility of a contract being canceled, renewed, or modified. The Company noted there was no additional variable consideration, significant financing components, noncash consideration, or consideration payable to the customer in these agreements. Pursuant to the Pint Agreement, the Company received a non-deductible, non-creditable upfront payment upon providing certain required documents on or before September 30, 2018 to the satisfaction of Pint. During the third quarter of 2018, the Company satisfied this performance obligation, and revenue has been recognized under the terms of the arrangement. The Pint Agreement also includes potential milestone and royalty payments due to the Company upon successful completion of certain performance obligations, such as achieving regulatory approvals, which would entitle the Company to receive payments totaling approximately $24.5 million if all respective performance obligations are achieved. During the third quarter of 2019 and the first quarter of 2020, the Company achieved certain development-based milestones, which satisfied performance obligations necessary to recognize the associated license revenue. The payments associated with this license revenue are included in accounts receivable, net on the consolidated balance sheet as of March 31, 2020 Royalty Revenue: 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. Royalties: Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 12 — Research and Development Expenses: Research and development expenses, or R&D, are charged to operations as incurred. The major components of R&D 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 research and development costs. 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 “trued-up” upon the actual forfeiture of a RSU grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates. Compensation expense related to modified restricted stock units is measured based on the fair value for the awards as of the modification date. Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite service period, as appropriate. Warrants : Warrants (refer to Note 10 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 for companies with a short period of publicly traded stock history, the Company’s estimate of expected volatility is based on the average volatilities of a sampling of eight to nine companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage. 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, 2020, 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 are pledged as collateral for stand-by letters of credit for lease and legal verdict commitments. The lease-related letters of credit will lapse at the end of the respective lease terms through 2026. At March 31, 2020 and December 31, 2019, the Company had restricted cash in the amount of $12.7 million and $13.2 million, respectively. 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 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. A decline in the market value of any available-for-sale security below cost that is determined to be other than temporary results in the revaluation of its carrying amount to fair value. The impairment is charged to earnings and a new cost basis for the security is established. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method. Interest income is recognized when earned. 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, 2020 and December 31, 2019, 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, 2020 Level 1 Level 2 Level 3 Total Cash equivalents $ 76,054 $ — $ — $ 76,054 Corporate bonds — 12,133 — 12,133 U.S. government securities 5,037 — — 5,037 Totals $ 81,091 $ 12,133 $ — $ 93,224 December 31, 2019 Level 1 Level 2 Level 3 Total Cash equivalents $ 41,295 $ — $ — $ 41,295 Corporate bonds — 41,557 — 41,557 U.S. government securities 10,050 — — 10,050 Totals $ 51,345 $ 41,557 $ — $ 92,902 The Company’s investments in corporate bonds and U.S. government securities are exposed to price fluctuations. The fair value measurements for 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, 2020 (in years) cost Gains Losses fair value Cash equivalents $ 76,054 $ — $ — $ 76,054 Corporate bonds Less than 1 12,135 — (2 ) 12,133 U.S. government securities Less than 1 5,033 4 — 5,037 Totals $ 93,222 $ 4 $ (2 ) $ 93,224 Maturity Amortized Unrealized Estimated December 31, 2019 (in years) cost Gains Losses fair value Cash equivalents $ 41,295 $ — $ — $ 41,295 Corporate bonds Less than 1 41,507 50 — $ 41,557 U.S. government securities Less than 1 10,038 12 — $ 10,050 Totals $ 92,840 $ 62 $ — $ 92,902 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, 2020, were approximately $98.6 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 as an allowance for doubtful accounts in the three months ended March 31, 2020 and 2019. The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, NERLYNX, and expects NERLYNX to constitute the vast majority of product revenue for the foreseeable future. The Company relies exclusively on third 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 ma |
Accounts Receivable, Net
Accounts Receivable, Net | 3 Months Ended |
Mar. 31, 2020 | |
Accounts Receivable Net [Abstract] | |
Accounts Receivable, Net | Note 3—Accounts Receivable, Net: Accounts receivable, net consisted of the following (in thousands): March 31, 2020 December 31, 2019 Accounts receivable, net $ 27,042 $ 26,396 License revenue receivable 4,500 2,500 Total accounts receivable, net $ 31,542 $ 28,896 Accounts receivable, net, consists entirely of amounts owed from our customers related to product sales. The license revenue receivable relates to amounts owed from Pint relating to license revenue recognized during the third quarter of 2019 and the first quarter of 2020. |
Prepaid Expenses and Other
Prepaid Expenses and Other | 3 Months Ended |
Mar. 31, 2020 | |
Banking And Thrift [Abstract] | |
Prepaid Expenses and Other | Note 4—Prepaid Expenses and Other: Prepaid expenses and other consisted of the following (in thousands): March 31, 2020 December 31, 2019 Current: CRO services $ 4,118 $ 4,810 Other clinical development 3,187 2,043 Insurance 2,502 3,452 Professional fees 1,127 544 Other 3,003 2,410 13,937 13,259 Long-term: CRO services 376 400 Other clinical development 476 468 Other 1,609 1,131 2,461 1,999 Totals $ 16,398 $ 15,258 Other prepaid amounts consist primarily of deposits, licenses, subscriptions and software. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Leases | Note 5—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 and 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 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 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 $ Supplemental cash flow information related to leases for the three months ended March 31, 2020: Operating cash flows for operating leases (in thousands) $ 1,400 Right-of-use assets obtained in exchange for new operating lease liabilities — Weighted average remaining lease term (in years) 6.0 Weighted average discount rate 10.9 % The maturity of lease liabilities as of March 31, 2020 were as follows (in thousands): Amount 2020 (remaining) $ 3,933 2021 5,365 2022 5,483 2023 5,631 2024 5,805 Thereafter 7,490 Total $ 33,707 Less: imputed interest (9,042 ) Total lease liabilities $ 24,665 In February 2019, the Company entered into a long-term sublease agreement for 12,429 square feet of the office space in Los Angeles, CA. The term of the lease runs until March 2026 The future minimum lease payments to be received as of March 31, 2020 were as follows (in thousands): Amount 2020 (remaining) $ 341 2021 467 2022 481 2023 495 2024 510 Thereafter 659 Total $ 2,953 |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Note 6—Property and Equipment, Net: Property and equipment, net consisted of the following (in thousands ): March 31, 2020 December 31, 2019 Leasehold improvements $ 3,779 $ 3,779 Computer equipment 2,698 2,698 Telephone equipment 340 340 Furniture and fixtures 2,360 2,346 9,177 9,163 Less: accumulated depreciation (6,092 ) (5,859 ) Totals $ 3,085 $ 3,304 For the three months ended March 31, 2020 and 2019, the Company incurred depreciation expense of $0.2 million and $0.2 million, respectively. |
Intangible Assets, Net
Intangible Assets, Net | 3 Months Ended |
Mar. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | Note 7—Intangible Assets, Net: Intangible assets, net consisted of the following (in thousands): March 31, 2020 Estimated Useful Life Acquired and in-licensed rights $ 50,000 13 Years Less: accumulated amortization (10,526 ) Total intangible asset, net $ 39,474 For the three months ended March 31, 2020 and 2019, the Company incurred amortization expense of $1.0 million and $1.0 million, respectively. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Note 8—Accrued Expenses: Accrued expenses consisted of the following (in thousands): March 31, 2020 December 31, 2019 Accrued legal verdict expense $ 31,443 $ 31,350 Accrued royalties 7,783 8,866 Accrued CRO services 6,811 8,502 Accrued variable consideration 9,709 7,978 Accrued bonus 2,271 1,618 Accrued compensation 4,196 4,138 Accrued other clinical development 2,044 2,546 Accrued professional fees 1,940 1,775 Accrued legal fees 646 266 Accrued manufacturing costs 1,327 869 Other 1,294 1,122 Totals $ 69,464 $ 69,030 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. Accrued legal verdict expense represents an estimate of a range between $9.1 million and $18.1 million that may be owed to class action participants as a result of the recent jury verdict in Hsu v. Puma Biotechnology, Inc., Eshelman v. Puma Biotechnology, Inc., et al . Hsu Eshelman Hsu, All accrued expenses are adjusted in the period the actual costs become known. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Note 9—Debt: Long term debt consisted of the following at March 31, 2020 (in thousands): March 31, 2020 Maturity Date Long-term debt $ 100,000 June 1, 2024 Accretion of final interest payment 2,260 Less: deferred financing costs (6,505 ) Total long-term debt, net $ 95,755 In October 2017, the Company entered into a loan and security agreement with Silicon Valley Bank, or SVB, as administrative agent, and the lenders party thereto from time to time, or the Original Lenders, including Oxford Finance LLC, or Oxford, and SVB. Pursuant to the terms of the credit facility provided for by the loan and security agreement, or the Original Credit Facility, the Company borrowed $50.0 million. In May 2018, the Company entered into an amendment to the loan and security agreement, which provided for an amended credit facility, or the Amended Credit Facility. Under the Amended Credit Facility, the Original Lenders agreed to make term loans available to the Company in an aggregate amount of $155.0 million, consisting of (i) an aggregate amount of $125.0 million, the proceeds of which, in part, were used to repay the $50.0 million borrowed under the Original Credit Facility, and (ii) an aggregate amount of $30.0 million that the Company drew in December 2018, which was available under the Amended Credit Facility as a result of achieving a specified minimum revenue milestone. The Company was in compliance with all applicable financial covenants during the entire term of the Amended Credit Facility. Prior to the amendment and restatement of the loan and security agreement in June 2019, which provided for a new credit facility, or the New Credit Facility, the term loans under the Amended Credit Facility bore interest at an annual rate equal to the greater of (i) 8.25% and (ii) the sum of (a) the “prime rate,” as reported in The Wall Street Journal on the last business day of the month that immediately preceded the month in which the interest accrued, plus (b) 3.5%. The Company was required to make monthly interest-only payments on each term loan commencing on the first 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 July 1, 2020. Commencing on July 1, 2020, and continuing on the first calendar day of each calendar month thereafter, the Company would have been required to make consecutive equal monthly payments of principal, together with applicable interest, in arrears to each original lender, calculated pursuant to the Amended Credit Facility. All unpaid principal and accrued and unpaid interest with respect to each term loan would have been due and payable in full on May 1, 2023. Upon repayment of the term loans, the Company was also required to make a final payment to the Original Lenders equal to 7.5% of the original principal amount of term loans funded. The Company was also permitted to prepay the outstanding principal balance of any term loan under the Amended Credit Facility, in whole but not in part, subject to a prepayment fee of 3.0% of any amount prepaid if the prepayment were to occur through and including the first anniversary of the funding date of such term loan, 2.0% of any amount prepaid if the prepayment were to occur 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 were to occur after the second anniversary of the funding date of such term loan and prior to May 1, 2023. On June 28, 2019, or the Effective Date, the Company entered into the New Credit Facility with Oxford, as collateral agent, and the lenders party thereto from time to time, including Oxford, pursuant to which the Company repaid the $155.0 million outstanding under the Amended Credit Facility, as well as all applicable exit and prepayment fees owed to the Original Lenders under the Amended 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 7.5% of the aggregate principal amount of such term loans outstanding as of the Effective Date. 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. As of March 31, 2020, there was $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, 2020 were as follows (in thousands): Amount 2020 (remaining) $ — 2021 14,286 2022 34,286 2023 34,286 2024 17,142 Thereafter — Total $ 100,000 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Note 10—Stockholders’ Equity: Common Stock: The Company issued 500 and 56,125 Authorized Shares: The Company has 100,000,000 shares of stock authorized for issuance, all of which 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, or Share Based Payment. 2020 2019 Dividend yield 0.0 % 0.0 % Expected volatility 102.7 % 99.9 % Risk-free interest rate 1.0 % 2.5 % Expected life in years 5.80 5.76 The Company’s 2017 Employment Inducement Incentive Award Plan, 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 common stock have been reserved for issuance under the 2017 Plan. As of March 31, 2020, 1,096,155 shares have been awarded under the 2017 Plan. Stock-based compensation expense was as follows (in thousands): For the Three Months Ended March 31, 2020 2019 Stock-based compensation: Options - Selling, general, and administrative $ 920 $ 2,986 Research and development 841 2,333 Restricted stock units - Selling, general, and administrative 3,772 6,889 Research and development 3,374 5,930 Total stock-based compensation expense $ 8,907 $ 18,138 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, 2019 5,042,325 $ 82.42 5.2 $ 1,951 Granted 606,800 $ 9.96 9.9 Forfeited - $ - Exercised (500 ) $ 3.75 $ 5 Expired (286,638 ) $ 84.66 Outstanding at March 31, 2020 5,361,987 $ 74.10 5.6 $ 1,974 Nonvested at March 31, 2020 975,127 $ 14.66 9.6 Exercisable 4,386,860 $ 87.32 4.7 $ 1,635 At March 31, 2020, total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $10.4 million, which is expected to be recognized over a weighted-average period of 2.1 years. At March 31, 2020, the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $35.5 million, which is expected to be recognized over a weighted-average period of 1.6 years. The weighted-average grant date fair value of options granted during the three months ended March 31, 2020 and 2019 was $7.86 and $21.82 per share, respectively. The weighted average grant date fair value of RSUs awarded during the three months ended March 31, 2020 and 2019 was $10.74 and $28.69 per share, respectively. Stock Option Rollforward Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2019 439,194 19.38 Granted 606,800 7.86 Vested/Issued (70,867 ) 29.61 Forfeited - - Nonvested shares at March 31, 2020 975,127 $ 11.47 Restricted Stock Unit Rollforward Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2019 1,991,125 $ 27.63 Granted 626,073 10.74 Vested/Issued (113,417 ) 48.96 Forfeited (229,681 ) 28.34 Nonvested shares at March 31, 2020 2,274,100 $ 21.85 |
401(k) Savings Plan
401(k) Savings Plan | 3 Months Ended |
Mar. 31, 2020 | |
Postemployment Benefits [Abstract] | |
401(k) Savings Plan | Note 11—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 $0.4 million and $0.4 million |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 12—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 be responsible for completing 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. Additionally, the Company may trigger a one-time milestone payment related to the commercialization efforts in certain European countries. 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 below. The Company records a liability in the consolidated financial statements for loss contingencies when a loss is known or considered probable and the amount can be reasonably estimated. If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better estimate than any other, the minimum amount of the range is accrued. If a loss is reasonably possible but not known or probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed. When determining the estimated loss or range of loss, significant judgment is required to estimate the amount and timing of a loss to be recorded. Currently, the Company has accrued estimated losses of $9.1 million related to Hsu v. Puma Biotechnology, Inc. Eshelman v. Puma Biotechnology, Inc., et al. Hsu v. Puma Biotechnology, Inc. On June 3, 2015, Hsingching Hsu, individually and on behalf of all others similarly situated, filed a class action lawsuit against the Company and certain of its executive officers in the United States District Court for the Central District of California (Case No. 8:15-cv-00865-AG-JCG). On October 16, 2015, lead plaintiff Norfolk Pension Fund filed a consolidated complaint on behalf of all persons who purchased the Company’s securities between July 22, 2014 and May 29, 2015. A trial on the claims relating to four statements alleged to have been false or misleading was held from January 15, 2019 to January 29, 2019. At trial, the jury found that three of the four challenged statements were not false or misleading, and thus found in the defendants’ favor on those claims. The jury found liability as to one statement and awarded a maximum of $4.50 per share in damages, which represents approximately 5% of the total claimed damages of $87.20 per share. Trading models suggest that approximately ten million shares traded during the class period may be eligible to claim damages. Based on prior lawsuits, the Company believes that the number of stockholders who submit proof of claims sufficient to recover damages is typically in the range of 20% to 40% of the total eligible shares. Based on these assumptions, total damages after claims could range from $9.0 million to $18.0 million. The total amount of aggregate class-wide damages remains uncertain and will be ascertained only after an extensive claims process and the exhaustion of any appeals and it is reasonably possible that the total damages will be higher than this estimate; however, the amount is not estimable at this time. On September 9, 2019, the Court entered an order specifying the rate of prejudgment interest to be awarded on any valid claims at the 52-week Treasury Bill rate. The Court’s order also established a claims process, which is expected to take about twelve months. A final judgment has not been entered. Based on the final total damages, the Company may owe a success-based legal fee to the Company’s legal counsel in the amount of $3.0 million. As the total damages remains uncertain, no liability has been recorded for the legal fee. The Company recognizes legal fees in connection with a loss contingency as incurred. Eshelman v. Puma Biotechnology, Inc., et al. In February 2016, Fredric N. Eshelman filed a lawsuit against the Company’s Chief Executive Officer and President, Alan H. Auerbach, and the Company in the United States District Court for the Eastern District of North Carolina (Case No. 7:16-cv-00018-D). The complaint generally alleged that Mr. Auerbach and the Company made defamatory statements regarding Dr. Eshelman in connection with a proxy contest. In May 2016, Dr. Eshelman filed a notice of voluntary dismissal of the claims against Mr. Auerbach. A trial on the remaining defamation claims against the Company took place from March 11 to March 15, 2019. At trial, the jury found the Company liable and awarded Dr. Eshelman $15.9 million in compensatory damages and $6.5 million in punitive damages. The Company strongly disagrees with the verdict and, on April 22, 2019, filed a motion for a new trial or, in the alternative, a reduced damages award. The Court denied that motion on March 2, 2020. The Company has appealed that ruling, and the verdict. Additionally, after trial, the plaintiff filed a motion seeking approximately $3 million in attorneys’ fees, as well as prejudgment interest. In the Court’s March 2 ruling, it denied the motion for attorneys’ fees but granted the request for prejudgment interest, bringing the total judgment to $26.3 million. On March 30, 2020, the plaintiff filed a notice of cross-appeal and conditional cross-appeal, appealing the Court’s order denying the plaintiff’s request for attorneys’ fees and conditionally cross-appealing a Court ruling that certain communications between Mr. Auerbach and his attorneys were protected by attorney-client privilege and a related evidentiary ruling. The Company estimates the high end of potential damages in the matter could be approximately $27.2 million; however, the actual amount of damages payable by the Company is still uncertain and will be ascertained only after completion of the appeal and any subsequent proceedings, and such amount could be greater than the amount of expense already recognized or the high end of the estimate. Due to the appeal, the Company secured a bond for the potential damages, which is collateralized by an automatically renewable stand-by letter of credit in the amount of $8.9 million. The stand-by letter of credit is collateralized by a high-yield savings account which is classified as restricted cash, current on the accompanying consolidated balance sheets. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 13—Subsequent Events: COVID-19 Pandemic: There are many uncertainties regarding the current global pandemic involving a novel strain of coronavirus, or COVID-19 , and the Company is closely monitoring the impact of the pandemic on all aspects of its business, including how it will impact its customers, employees, suppliers, vendors, business partners and distribution channels. The Company is unable to predict the impact that COVID-19 will have on its financial position and operating results due to numerous uncertainties. The Company expects to continue to assess the evolving impact of the COVID-19 pandemic and intends to make adjustments to its responses accordingly. Paycheck Protection Program Loan: On April 20, 2020, the Company received loan proceeds from SVB of $8.4 million under the Paycheck Protection Program, or PPP, of the Coronavirus Aid, Relief, and Economic Security Act. Following the issuance of additional guidance from the U. S. Small Business Administration regarding eligibility requirements for borrowers under the PPP, the Company returned the full amount of the loan to SVB on April 30, 2020. Mainland China Marketing Approval: On April 27, 2020, the Company’s sub-licensee, CANbridge Limited, received marketing approval of NERLYNX (neratinib) in mainland China from the National Medical Products Administration of China for the extended adjuvant treatment of adult patients with early stage HER2 positive breast cancer, to follow adjuvant trastuzumab-based therapy. Bixink Agreement: On April 28, 2020, the Company entered into a sub-license agreement, or the Bixink Agreement, with Bixink Therapeutics. Pursuant to the Bixink Agreement, the Company granted to Bixink, under certain of the Company’s intellectual property rights relating to neratinib, an exclusive, sublicensable (under certain circumstances) license (i) to develop and commercialize any product containing neratinib and certain related compounds in South Korea, or the Bixink Territory and (ii) to seek and maintain regulatory approvals for the licensed products in the Bixink Territory. Pursuant to the Bixink Agreement, the Company will receive upfront and milestone payments of up to $6 million, each milestone payment payable upon the achievement of the milestone event specified in the Bixink Agreement. In addition, the Company is entitled to receive double digit royalties calculated as a percentage of net sales of the licensed products in the Bixink Territory. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
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 Loss per Share of Common Stock | Net Loss per Share of Common Stock: Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the periods presented, as required by Accounting Standards Codification, or ASC, 260, Earnings per Share For the quarter ended March 31, 2019, potentially dilutive securities excluded from the calculations were 5,554,070 shares issuable upon exercise of options, 2,116,250 shares issuable upon exercise of a warrant, and 1,698,146 shares underlying RSUs that were subject to vesting and were antidilutive |
Revenue Recognition | Revenue Recognition: The Company adopted ASC Topic 606, Revenue from Contracts with Customers To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identifies the contract(s) with a customer, (ii) identifies the performance obligations in the contract, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations in the contract, and (v) recognizes revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net (below). 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 quarter ended March 31, 2020. Product revenue from each of the Company’s customers who individually accounted for 10% or more of total revenues consisted of the following: For the Three Months Ended March 31, 2020 Caremark, LLC 33% Accredo Health Group, Inc. / AcariaHealth, Inc. 21% Biologics, Inc. 11% ASD Healthcare and Oncology Supply 11% For the Three Months Ended March 31, 2019 Caremark, LLC 30% Accredo Health Group, Inc. / AcariaHealth, Inc. 25% Biologics, Inc. 11% Diplomat Pharmacy, Inc. 11% 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 or as a current liability. These estimates take into consideration a range of possible outcomes that are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. 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 material reversal of revenue would not occur in a future period for the estimates detailed below as of March 31, 20 20 and, therefore, the transaction price was not reduced further during the quarter ended March 31, 20 20 . 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 receivables, net on the consolidated balance sheets. In addition, the Company compensates its customers for sales order management, data, and distribution services. The Company has determined such services received to date are not 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 statement 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 receivables, 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 are established in the same period that 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. Pint Agreement During 2018, the Company entered into a sub-license agreement, or the Pint Agreement, with Pint Pharma International SA, or Pint. The Pint Agreement granted intellectual property rights and set forth the respective obligations with respect to development, commercialization and supply of NERLYNX in Mexico and 21 countries and territories in Central and South America, or the Pint Territory. The Pint Agreement met the contract existence criteria and contained distinct, identifiable performance obligations for which the stand-alone selling prices were readily determinable and allocable. The Company is obligated to supply Pint with the licensed product during development pursuant to a supply agreement. This supply arrangement has been identified as a separate performance obligation. To determine the respective stand-alone selling prices, the Company estimated the transaction prices, including any variable consideration, at contract inception and determined the fair value of such obligations based on similar arrangements. When determining the transaction prices, the Company assumed that the goods or services will be transferred to the customer based on the terms of the existing contract and did not take into consideration the possibility of a contract being canceled, renewed, or modified. The Company noted there was no additional variable consideration, significant financing components, noncash consideration, or consideration payable to the customer in these agreements. Pursuant to the Pint Agreement, the Company received a non-deductible, non-creditable upfront payment upon providing certain required documents on or before September 30, 2018 to the satisfaction of Pint. During the third quarter of 2018, the Company satisfied this performance obligation, and revenue has been recognized under the terms of the arrangement. The Pint Agreement also includes potential milestone and royalty payments due to the Company upon successful completion of certain performance obligations, such as achieving regulatory approvals, which would entitle the Company to receive payments totaling approximately $24.5 million if all respective performance obligations are achieved. During the third quarter of 2019 and the first quarter of 2020, the Company achieved certain development-based milestones, which satisfied performance obligations necessary to recognize the associated license revenue. The payments associated with this license revenue are included in accounts receivable, net on the consolidated balance sheet as of March 31, 2020 Royalty Revenue: 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. |
Royalties | Royalties: Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 12 — |
Research and Development Expenses | Research and Development Expenses: Research and development expenses, or R&D, are charged to operations as incurred. The major components of R&D 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 research and development costs. |
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 “trued-up” upon the actual forfeiture of a RSU grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates. Compensation expense related to modified restricted stock units is measured based on the fair value for the awards as of the modification date. Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite service period, as appropriate. Warrants : Warrants (refer to Note 10 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 for companies with a short period of publicly traded stock history, the Company’s estimate of expected volatility is based on the average volatilities of a sampling of eight to nine companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage. 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, 2020, 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 are pledged as collateral for stand-by letters of credit for lease and legal verdict commitments. The lease-related letters of credit will lapse at the end of the respective lease terms through 2026. At March 31, 2020 and December 31, 2019, the Company had restricted cash in the amount of $12.7 million and $13.2 million, respectively. |
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 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. A decline in the market value of any available-for-sale security below cost that is determined to be other than temporary results in the revaluation of its carrying amount to fair value. The impairment is charged to earnings and a new cost basis for the security is established. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method. Interest income is recognized when earned. |
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, 2020 and December 31, 2019, 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, 2020 Level 1 Level 2 Level 3 Total Cash equivalents $ 76,054 $ — $ — $ 76,054 Corporate bonds — 12,133 — 12,133 U.S. government securities 5,037 — — 5,037 Totals $ 81,091 $ 12,133 $ — $ 93,224 December 31, 2019 Level 1 Level 2 Level 3 Total Cash equivalents $ 41,295 $ — $ — $ 41,295 Corporate bonds — 41,557 — 41,557 U.S. government securities 10,050 — — 10,050 Totals $ 51,345 $ 41,557 $ — $ 92,902 The Company’s investments in corporate bonds and U.S. government securities are exposed to price fluctuations. The fair value measurements for 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, 2020 (in years) cost Gains Losses fair value Cash equivalents $ 76,054 $ — $ — $ 76,054 Corporate bonds Less than 1 12,135 — (2 ) 12,133 U.S. government securities Less than 1 5,033 4 — 5,037 Totals $ 93,222 $ 4 $ (2 ) $ 93,224 Maturity Amortized Unrealized Estimated December 31, 2019 (in years) cost Gains Losses fair value Cash equivalents $ 41,295 $ — $ — $ 41,295 Corporate bonds Less than 1 41,507 50 — $ 41,557 U.S. government securities Less than 1 10,038 12 — $ 10,050 Totals $ 92,840 $ 62 $ — $ 92,902 |
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, 2020, were approximately $98.6 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 as an allowance for doubtful accounts in the three months ended March 31, 2020 and 2019. The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, NERLYNX, and expects NERLYNX to constitute the vast majority of product revenue for the foreseeable future. The Company relies exclusively on third 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 totaling $4.5 million, acquired prior to receipt of marketing approval of a product candidate, was recorded as research and development expense in the year ended December 31, 2017. Inventory that can be used in either the production of clinical or commercial product is recorded as research and development expense when selected for use in a clinical trial. Starter kits, provided to patients prior to insurance approval, are expensed by the Company to selling, general and administrative expense as incurred. As of March 31, 2020, 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. Leases will be classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. For additional information, see Note 5 — 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 renewals 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 the options to purchase the leased property. The depreciable life of assets and leasehold improvements are 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 that 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, 2020 is 10.9%. The Company decided to cease the use of a portion of its leased office space in 2019. In connection with the decreased need for the right to use the ROU asset, the Company entered into a sublease for the underlying asset, in which the sublease income is less than the original lease payments, indicating impairment. In performing the recoverability test on the effective date, the undiscounted future estimated cash flows and carrying value were identified for the subleased portion of the leased building, as an individual asset group, defined under ASC 360. A reduction to the carrying value of the ROU asset was recorded of approximately $1.2 million representing the fair value amount in excess of the carrying value, with a corresponding impairment charge recorded as selling, general and administration expense, in the consolidated statements of operations for the year ended December 31, 2019. There were no indications for impairment during the quarter ended March 31, 2020. |
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. The Company capitalized the milestone payment as an intangible asset and is amortizing the asset 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 asset of $1.0 million for both the three months ended March 31, 2020 and 2019. As of March 31, 2020, estimated future amortization expense related to the Company’s intangible asset was approximately $2.9 million for the remainder of 2020 and $3.9 million for each year starting 2021 through 2029, and $1.0 million for 2030 |
Recently Issued Accounting Standards | Recently Issued Accounting Standards: In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. These amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2019. The adoption of ASU 2016-13 did not have a material effect on the Company’s current financial position, results of operations or financial statement disclosures. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement. The amendments in ASU 2018-13 modifies the disclosure requirements on fair value measurements. ASU 2018-13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted for any removed or modified disclosures. The amendments did not have an impact on the Company’s financial statement disclosures. 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 removes 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. The Company does not expect ASU 2019-12 to have a material effect on the Company’s current financial position, results of operations or financial statement disclosures. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Product Revenues from Customers | Product revenue from each of the Company’s customers who individually accounted for 10% or more of total revenues consisted of the following: For the Three Months Ended March 31, 2020 Caremark, LLC 33% Accredo Health Group, Inc. / AcariaHealth, Inc. 21% Biologics, Inc. 11% ASD Healthcare and Oncology Supply 11% For the Three Months Ended March 31, 2019 Caremark, LLC 30% Accredo Health Group, Inc. / AcariaHealth, Inc. 25% Biologics, Inc. 11% Diplomat Pharmacy, Inc. 11% |
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, 2020 and December 31, 2019, 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, 2020 Level 1 Level 2 Level 3 Total Cash equivalents $ 76,054 $ — $ — $ 76,054 Corporate bonds — 12,133 — 12,133 U.S. government securities 5,037 — — 5,037 Totals $ 81,091 $ 12,133 $ — $ 93,224 December 31, 2019 Level 1 Level 2 Level 3 Total Cash equivalents $ 41,295 $ — $ — $ 41,295 Corporate bonds — 41,557 — 41,557 U.S. government securities 10,050 — — 10,050 Totals $ 51,345 $ 41,557 $ — $ 92,902 |
Summary of Short-term Investments | The following tables summarize the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Estimated March 31, 2020 (in years) cost Gains Losses fair value Cash equivalents $ 76,054 $ — $ — $ 76,054 Corporate bonds Less than 1 12,135 — (2 ) 12,133 U.S. government securities Less than 1 5,033 4 — 5,037 Totals $ 93,222 $ 4 $ (2 ) $ 93,224 Maturity Amortized Unrealized Estimated December 31, 2019 (in years) cost Gains Losses fair value Cash equivalents $ 41,295 $ — $ — $ 41,295 Corporate bonds Less than 1 41,507 50 — $ 41,557 U.S. government securities Less than 1 10,038 12 — $ 10,050 Totals $ 92,840 $ 62 $ — $ 92,902 |
Accounts Receivable, Net (Table
Accounts Receivable, Net (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accounts Receivable Net [Abstract] | |
Schedule of Accounts Receivable, Net | Accounts receivable, net consisted of the following (in thousands): March 31, 2020 December 31, 2019 Accounts receivable, net $ 27,042 $ 26,396 License revenue receivable 4,500 2,500 Total accounts receivable, net $ 31,542 $ 28,896 |
Prepaid Expenses and Other (Tab
Prepaid Expenses and Other (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Banking And Thrift [Abstract] | |
Components of Prepaid Expenses and Other | Prepaid expenses and other consisted of the following (in thousands): March 31, 2020 December 31, 2019 Current: CRO services $ 4,118 $ 4,810 Other clinical development 3,187 2,043 Insurance 2,502 3,452 Professional fees 1,127 544 Other 3,003 2,410 13,937 13,259 Long-term: CRO services 376 400 Other clinical development 476 468 Other 1,609 1,131 2,461 1,999 Totals $ 16,398 $ 15,258 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases for the three months ended March 31, 2020: Operating cash flows for operating leases (in thousands) $ 1,400 Right-of-use assets obtained in exchange for new operating lease liabilities — Weighted average remaining lease term (in years) 6.0 Weighted average discount rate 10.9 % |
Maturity of Lease Liabilities | The maturity of lease liabilities as of March 31, 2020 were as follows (in thousands): Amount 2020 (remaining) $ 3,933 2021 5,365 2022 5,483 2023 5,631 2024 5,805 Thereafter 7,490 Total $ 33,707 Less: imputed interest (9,042 ) Total lease liabilities $ 24,665 |
Future Minimum Lease Payments to be Received | The future minimum lease payments to be received as of March 31, 2020 were as follows (in thousands): Amount 2020 (remaining) $ 341 2021 467 2022 481 2023 495 2024 510 Thereafter 659 Total $ 2,953 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands ): March 31, 2020 December 31, 2019 Leasehold improvements $ 3,779 $ 3,779 Computer equipment 2,698 2,698 Telephone equipment 340 340 Furniture and fixtures 2,360 2,346 9,177 9,163 Less: accumulated depreciation (6,092 ) (5,859 ) Totals $ 3,085 $ 3,304 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets, Net | Intangible assets, net consisted of the following (in thousands): March 31, 2020 Estimated Useful Life Acquired and in-licensed rights $ 50,000 13 Years Less: accumulated amortization (10,526 ) Total intangible asset, net $ 39,474 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following (in thousands): March 31, 2020 December 31, 2019 Accrued legal verdict expense $ 31,443 $ 31,350 Accrued royalties 7,783 8,866 Accrued CRO services 6,811 8,502 Accrued variable consideration 9,709 7,978 Accrued bonus 2,271 1,618 Accrued compensation 4,196 4,138 Accrued other clinical development 2,044 2,546 Accrued professional fees 1,940 1,775 Accrued legal fees 646 266 Accrued manufacturing costs 1,327 869 Other 1,294 1,122 Totals $ 69,464 $ 69,030 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Long Term Debt | Long term debt consisted of the following at March 31, 2020 (in thousands): March 31, 2020 Maturity Date Long-term debt $ 100,000 June 1, 2024 Accretion of final interest payment 2,260 Less: deferred financing costs (6,505 ) Total long-term debt, net $ 95,755 |
Future Minimum Principal Payments Under New Credit Facility | The future minimum principal payments under the New Credit Facility as of March 31, 2020 were as follows (in thousands): Amount 2020 (remaining) $ — 2021 14,286 2022 34,286 2023 34,286 2024 17,142 Thereafter — Total $ 100,000 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Fair Value Options Weighted-Average Assumptions | The fair value of options granted to employees and nonemployees was estimated using the Black-Scholes Option Pricing Method (see Note 2) with the following weighted-average assumptions used during the three months ended March 31: 2020 2019 Dividend yield 0.0 % 0.0 % Expected volatility 102.7 % 99.9 % Risk-free interest rate 1.0 % 2.5 % Expected life in years 5.80 5.76 |
Stock-based Compensation Expense | Stock-based compensation expense was as follows (in thousands): For the Three Months Ended March 31, 2020 2019 Stock-based compensation: Options - Selling, general, and administrative $ 920 $ 2,986 Research and development 841 2,333 Restricted stock units - Selling, general, and administrative 3,772 6,889 Research and development 3,374 5,930 Total stock-based compensation expense $ 8,907 $ 18,138 |
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, 2019 5,042,325 $ 82.42 5.2 $ 1,951 Granted 606,800 $ 9.96 9.9 Forfeited - $ - Exercised (500 ) $ 3.75 $ 5 Expired (286,638 ) $ 84.66 Outstanding at March 31, 2020 5,361,987 $ 74.10 5.6 $ 1,974 Nonvested at March 31, 2020 975,127 $ 14.66 9.6 Exercisable 4,386,860 $ 87.32 4.7 $ 1,635 |
Stock Options | The weighted-average grant date fair value of options granted during the three months ended March 31, 2020 and 2019 was $7.86 and $21.82 per share, respectively. Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2019 439,194 19.38 Granted 606,800 7.86 Vested/Issued (70,867 ) 29.61 Forfeited - - Nonvested shares at March 31, 2020 975,127 $ 11.47 |
Restricted Stock Units | The weighted average grant date fair value of RSUs awarded during the three months ended March 31, 2020 and 2019 was $10.74 and $28.69 per share, Shares Weighted Average Grant-Date Fair Value Nonvested shares at December 31, 2019 1,991,125 $ 27.63 Granted 626,073 10.74 Vested/Issued (113,417 ) 48.96 Forfeited (229,681 ) 28.34 Nonvested shares at March 31, 2020 2,274,100 $ 21.85 |
Business and Basis of Present_2
Business and Basis of Presentation - Additional Information (Detail) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2020USD ($)Subsidiary | Mar. 31, 2019USD ($) | Dec. 31, 2019USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||
Number of subsidiaries | Subsidiary | 2 | ||
Net loss | $ (16,933) | $ (10,087) | |
Net cash used in operating activities | (11,540) | $ (16,130) | |
Cash and cash equivalents | 83,385 | $ 60,037 | |
Marketable securities | $ 17,170 | $ 51,607 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2020USD ($)Segmentshares | Mar. 31, 2019USD ($)shares | Dec. 31, 2019USD ($) | Dec. 31, 2017USD ($) | |
Significant Accounting Policies [Line Items] | ||||
Number of segments | Segment | 1 | |||
Incremental costs expenses | $ 0 | |||
Restricted cash | 12,700,000 | $ 13,200,000 | ||
Cash and cash equivalents and restricted cash in excess of insured limits | 98,600,000 | |||
Allowance for doubtful accounts | $ 0 | $ 0 | ||
Research and development expense related to inventory | $ 4,500,000 | |||
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% | |||
Reduction in carrying value of right of use asset | $ 1,200,000 | |||
Amortization expenses related to intangible assets | $ 1,000,000 | 1,000,000 | ||
Estimated future amortization expense related to intangible assets, remainder of 2020 | 2,900,000 | |||
Estimated future amortization expense related to intangible assets, 2021 | $ 3,900,000 | |||
Estimated future amortization expense related to intangible assets, 2022 | 3,900,000 | |||
Estimated future amortization expense related to intangible assets, 2023 | 3,900,000 | |||
Estimated future amortization expense related to intangible assets, 2024 | 3,900,000 | |||
Estimated future amortization expense related to intangible assets, 2025 | 3,900,000 | |||
Estimated future amortization expense related to intangible assets, 2026 | 3,900,000 | |||
Estimated future amortization expense related to intangible assets, 2027 | 3,900,000 | |||
Estimated future amortization expense related to intangible assets, 2028 | 3,900,000 | |||
Estimated future amortization expense related to intangible assets, 2029 | 3,900,000 | |||
Estimated future amortization expense related to intangible assets, 2030 | $ 1,000,000 | |||
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 | |||
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 | |||
Maximum | Pint Pharma International SA | License Agreement | ||||
Significant Accounting Policies [Line Items] | ||||
Potential milestone and royalty payments receivable | $ 24,500,000 | |||
Employee Stock Option | ||||
Significant Accounting Policies [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted earnings per share | shares | 4,330,242 | 5,554,070 | ||
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 | 2,274,100 | 1,698,146 |
Summary of Product Revenues fro
Summary of Product Revenues from Customers (Detail) - Customer Concentration Risk - Total Revenues | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Caremark, LLC | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk percentage | 33.00% | 30.00% |
Accredo Health Group, Inc. / AcariaHealth, Inc. | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk percentage | 21.00% | 25.00% |
Biologics, Inc. | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk percentage | 11.00% | 11.00% |
ASD Healthcare and Oncology Supply | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk percentage | 11.00% | |
Diplomat Pharmacy, Inc. | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk percentage | 11.00% |
Assets Measured at Fair Value o
Assets Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 76,054 | $ 41,295 |
Totals | 93,224 | 92,902 |
Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 12,133 | 41,557 |
U.S. government securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 5,037 | 10,050 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 76,054 | 41,295 |
Totals | 81,091 | 51,345 |
Level 1 | U.S. government securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 5,037 | 10,050 |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Totals | 12,133 | 41,557 |
Level 2 | Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 12,133 | $ 41,557 |
Summary of Short-term Investmen
Summary of Short-term Investments (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, Amortized cost | $ 93,222 | $ 92,840 |
Marketable securities, Unrealized Gains | 4 | 62 |
Marketable securities, Unrealized Losses | (2) | |
Marketable securities, Estimated fair value | 93,224 | 92,902 |
Cash equivalents, Amortized cost | 83,385 | 60,037 |
Cash Equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cash equivalents, Amortized cost | 76,054 | 41,295 |
Cash equivalents, Estimated fair value | $ 76,054 | $ 41,295 |
Corporate bonds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, Maturity (in years) | Less than 1 | Less than 1 |
Marketable securities, Amortized cost | $ 12,135 | $ 41,507 |
Marketable securities, Unrealized Gains | 50 | |
Marketable securities, Unrealized Losses | (2) | |
Marketable securities, Estimated fair value | $ 12,133 | $ 41,557 |
U.S. government securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, Maturity (in years) | Less than 1 | Less than 1 |
Marketable securities, Amortized cost | $ 5,033 | $ 10,038 |
Marketable securities, Unrealized Gains | 4 | 12 |
Marketable securities, Estimated fair value | $ 5,037 | $ 10,050 |
Accounts Receivable, Net - Sche
Accounts Receivable, Net - Schedule of Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Accounts Receivable Net [Abstract] | ||
Accounts receivable, net | $ 27,042 | $ 26,396 |
License revenue receivable | 4,500 | 2,500 |
Total accounts receivable, net | $ 31,542 | $ 28,896 |
Components of Prepaid Expenses
Components of Prepaid Expenses and Other (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | $ 13,937 | $ 13,259 |
Prepaid expenses and other, long-term | 2,461 | 1,999 |
Totals | 16,398 | 15,258 |
CRO services | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 4,118 | 4,810 |
Prepaid expenses and other, long-term | 376 | 400 |
Other clinical development | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 3,187 | 2,043 |
Prepaid expenses and other, long-term | 476 | 468 |
Insurance | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 2,502 | 3,452 |
Professional fees | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 1,127 | 544 |
Other | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 3,003 | 2,410 |
Prepaid expenses and other, long-term | $ 1,609 | $ 1,131 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Millions | 1 Months Ended | 3 Months Ended | |||
Feb. 28, 2019ft² | Jun. 30, 2012USD ($)ft² | Dec. 31, 2011USD ($)ft² | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) | |
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, CA | |||||
Leases [Line Items] | |||||
Percentage of increase in annual rent | 3.00% | ||||
Existing square feet of subleased property | ft² | 12,429 | ||||
Sublease expiration date | Mar. 31, 2026 | ||||
Lease Agreement executed on December 2011 | |||||
Leases [Line Items] | |||||
Office lease, lease term | 7 years | ||||
Existing square feet of leased property | ft² | 65,656 | ||||
Lease expiration date | Mar. 31, 2026 | ||||
Percentage of increase in annual rent | 3.00% | ||||
Office space, lease extension Stand-by letter of credit | $ 2.5 | ||||
Lease Agreement executed on June 2012 | |||||
Leases [Line Items] | |||||
Existing square feet of leased property | ft² | 29,470 | ||||
Lease expiration date | Mar. 31, 2026 | ||||
Percentage of increase in annual rent | 3.00% | ||||
Office space, lease extension Stand-by letter of credit | $ 1.6 | ||||
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, 2020USD ($) | |
Leases [Abstract] | |
Operating cash flows for operating leases (in thousands) | $ 1,400 |
Weighted average remaining lease term (in years) | 6 years |
Weighted average discount rate | 10.90% |
Maturity of Lease Liabilities (
Maturity of Lease Liabilities (Detail) $ in Thousands | Mar. 31, 2020USD ($) |
Leases [Abstract] | |
2020 (remaining) | $ 3,933 |
2021 | 5,365 |
2022 | 5,483 |
2023 | 5,631 |
2024 | 5,805 |
Thereafter | 7,490 |
Total | 33,707 |
Less: imputed interest | (9,042) |
Total lease liabilities | $ 24,665 |
Future Minimum Lease Payments t
Future Minimum Lease Payments to be Received (Detail) $ in Thousands | Mar. 31, 2020USD ($) |
Leases [Abstract] | |
2020 (remaining) | $ 341 |
2021 | 467 |
2022 | 481 |
2023 | 495 |
2024 | 510 |
Thereafter | 659 |
Total | $ 2,953 |
Property and Equipment, Net (De
Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 9,177 | $ 9,163 |
Less: accumulated depreciation | (6,092) | (5,859) |
Totals | 3,085 | 3,304 |
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 | 2,698 | 2,698 |
Telephone Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 340 | 340 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 2,360 | $ 2,346 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 0.2 | $ 0.2 |
Schedule of Intangible Assets,
Schedule of Intangible Assets, Net (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Finite Lived Intangible Assets [Line Items] | ||
Acquired and in-licensed rights | $ 50,000 | |
Less: accumulated amortization | (10,526) | |
Total intangible asset, net | $ 39,474 | $ 40,461 |
Acquired and in-licensed rights | ||
Finite Lived Intangible Assets [Line Items] | ||
Estimated Useful Life | 13 years |
Intangible Assets, Net - Additi
Intangible Assets, Net - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | ||
Amortization expense | $ 1 | $ 1 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued legal verdict expense | $ 31,443 | $ 31,350 |
Accrued royalties | 7,783 | 8,866 |
Accrued CRO services | 6,811 | 8,502 |
Accrued variable consideration | 9,709 | 7,978 |
Accrued bonus | 2,271 | 1,618 |
Accrued compensation | 4,196 | 4,138 |
Accrued other clinical development | 2,044 | 2,546 |
Accrued professional fees | 1,940 | 1,775 |
Accrued legal fees | 646 | 266 |
Accrued manufacturing costs | 1,327 | 869 |
Other | 1,294 | 1,122 |
Totals | $ 69,464 | $ 69,030 |
Accrued Expenses - Additional I
Accrued Expenses - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Accrued Expenses [Line Items] | ||
Accrued legal verdict expense, estimate owed | $ 31,443 | $ 31,350 |
Eshelman v. Puma Biotechnology, Inc. | ||
Accrued Expenses [Line Items] | ||
Accrued legal verdict expense, estimate owed | 22,400 | |
Minimum | Hsu v. Puma Biotechnology, Inc. | ||
Accrued Expenses [Line Items] | ||
Accrued legal verdict expense, estimate owed | 9,100 | |
Maximum | Hsu v. Puma Biotechnology, Inc. | ||
Accrued Expenses [Line Items] | ||
Accrued legal verdict expense, estimate owed | $ 18,100 |
Debt - Schedule of Long Term De
Debt - Schedule of Long Term Debt (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Debt Disclosure [Abstract] | ||
Long-term debt | $ 100,000 | |
Accretion of final interest payment | 2,260 | |
Less: deferred financing costs | (6,505) | |
Total long-term debt, net | $ 95,755 | $ 94,962 |
Long term debt, maturity date | Jun. 1, 2024 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) | Jun. 28, 2019 | May 31, 2018 | Oct. 31, 2017 | Mar. 31, 2020 |
Silicon Valley Bank and Oxford Finance LLC | Term Loan | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, effective date | 2017-10 | |||
Amount borrowed under credit facility | $ 125,000,000 | $ 50,000,000 | ||
Term loan, maximum borrowing capacity | 155,000,000 | |||
Payment of existing credit facility | 50,000,000 | |||
Line of credit facility available upon achievement of specified minimum revenue milestone | $ 30,000,000 | |||
Interest rate, description | Prior to the amendment and restatement of the loan and security agreement in June 2019, which provided for a new credit facility, or the New Credit Facility, the term loans under the Amended Credit Facility bore interest at an annual rate equal to the greater of (i) 8.25% and (ii) the sum of (a) the “prime rate,” as reported in The Wall Street Journal on the last business day of the month that immediately preceded the month in which the interest accrued, plus (b) 3.5%. The Company was required to make monthly interest-only payments on each term loan commencing on the first 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 July 1, 2020 | |||
Annual interest rate | 8.25% | |||
Redemption period start date | Jul. 1, 2020 | |||
Line of credit facility closing date | May 1, 2023 | |||
Percentage of original principal amount payable in final payment | 7.50% | |||
Silicon Valley Bank and Oxford Finance LLC | Term Loan | First Anniversary of Funding | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee, percentage | 3.00% | |||
Silicon Valley Bank and Oxford Finance LLC | Term Loan | Between First Anniversary and Second Anniversary | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee, percentage | 2.00% | |||
Silicon Valley Bank and Oxford Finance LLC | Term Loan | After Second Anniversary and Prior to May 1, 2023 | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee, percentage | 1.00% | |||
Silicon Valley Bank and Oxford Finance LLC | Term Loan | Prime Rate | ||||
Debt Instrument [Line Items] | ||||
Basis spread on variable rate | 3.50% | |||
Oxford | Secured Promissory Notes | ||||
Debt Instrument [Line Items] | ||||
Term loan, maximum borrowing capacity | $ 100,000,000 | |||
Payment of existing credit facility | $ 155,000,000 | |||
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% | |||
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% | |||
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% | |||
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 | |||
Principal amounts 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) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
Total long-term debt, net | $ 95,755 | $ 94,962 |
Secured Promissory Notes | ||
Debt Instrument [Line Items] | ||
2021 | 14,286 | |
2022 | 34,286 | |
2023 | 34,286 | |
2024 | 17,142 | |
Total long-term debt, net | $ 100,000 |
Stockholders Equity - Additiona
Stockholders Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Oct. 31, 2011 | |
Stockholders Equity Note [Line Items] | ||||
Issuance of common stock on exercise of option | 500 | |||
Common stock issued upon vesting of RSUs | 113,417 | 192,912 | ||
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 | 5,361,987 | 5,042,325 | ||
Share based compensation awarded | 606,800 | |||
Weighted-average grant date fair value of options granted | $ 7.86 | |||
Non Vested Stock Options | ||||
Stockholders Equity Note [Line Items] | ||||
Estimated unrecognized employee compensation cost related to non-vested stock options granted | $ 10.4 | |||
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 | 113,417 | |||
Estimated unrecognized employee compensation cost related to non-vested stock options granted | $ 35.5 | |||
Estimated unrecognized employee compensation cost related to non-vested stock options granted, Weighted-average period of recognition | 1 year 7 months 6 days | |||
Weighted-average grant date fair value of options granted | $ 7.86 | $ 21.82 | ||
Weighted-average grant date fair value of RSUs | $ 10.74 | $ 28.69 | ||
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 | 6,539,932 | |||
Common stock shares available for future issuance | 2,070,707 | |||
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 | |||
Share based compensation awarded | 1,096,155 | |||
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 | 500 | 56,125 | ||
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% |
Fair Value Options Weighted-Ave
Fair Value Options Weighted-Average Assumptions (Detail) - Employee And Nonemployee Stock Option | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility | 102.70% | 99.90% |
Risk-free interest rate | 1.00% | 2.50% |
Expected life in years | 5 years 9 months 18 days | 5 years 9 months 3 days |
Stock-based Compensation Expens
Stock-based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 8,907 | $ 18,138 |
Employee Stock Option | Selling, general and administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | 920 | 2,986 |
Employee Stock Option | Research and development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | 841 | 2,333 |
Restricted Stock Units | Selling, general and administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | 3,772 | 6,889 |
Restricted Stock Units | Research and development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 3,374 | $ 5,930 |
Activity with Respect to Option
Activity with Respect to Options Granted (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Shares | ||
Beginning balance, shares | 5,042,325 | |
Granted, shares | 606,800 | |
Exercised, shares | (500) | |
Expired, shares | (286,638) | |
Ending balance, shares | 5,361,987 | 5,042,325 |
Nonvested, shares | 975,127 | 439,194 |
Exercisable, shares | 4,386,860 | |
Weighted Average Exercise Price | ||
Beginning Balance, Weighted Average Exercise Price | $ 82.42 | |
Granted, Weighted Average Exercise Price | 9.96 | |
Exercised, Weighted Average Exercise Price | 3.75 | |
Expired, Weighted Average Exercise Price | 84.66 | |
Ending Balance, Weighted Average Exercise Price | 74.10 | $ 82.42 |
Nonvested, Weighted Average Exercise Price | 14.66 | |
Exercisable, Weighted Average Exercise Price | $ 87.32 | |
Weighted Average Remaining Contractual Term (years) | ||
Weighted Average Remaining Contractual Term (years) | 5 years 7 months 6 days | 5 years 2 months 12 days |
Granted, Weighted Average Remaining Contractual Term (years) | 9 years 10 months 24 days | |
Nonvested, Weighted Average Remaining Contractual Term (years) | 9 years 7 months 6 days | |
Exercisable, Weighted Average Remaining Contractual Term (years) | 4 years 8 months 12 days | |
Aggregate Intrinsic Value | ||
Shares, Outstanding, Aggregate Intrinsic Value | $ 1,974 | $ 1,951 |
Exercised, Aggregate Intrinsic Value | 5 | |
Exercisable, Aggregate Intrinsic Value | $ 1,635 |
Stock Options (Detail)
Stock Options (Detail) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Shares | |
Nonvested shares, Beginning balance | shares | 439,194 |
Granted, shares | shares | 606,800 |
Vested/Issued, shares | shares | (70,867) |
Nonvested shares, Ending balance | shares | 975,127 |
Weighted Average Grant-Date Fair Value | |
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value | $ / shares | $ 19.38 |
Granted, Weighted Average Grant-Date Fair Value | $ / shares | 7.86 |
Vested/Issued, Weighted Average Grant-Date Fair Value | $ / shares | 29.61 |
Nonvested, Ending balance, Weighted Average Grant-Date Fair Value | $ / shares | $ 11.47 |
Restricted Stock Units (Detail)
Restricted Stock Units (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Shares | ||
Vested/Issued, shares | (113,417) | (192,912) |
Restricted Stock Units | ||
Shares | ||
Nonvested shares, Beginning balance | 1,991,125 | |
Granted, shares | 626,073 | |
Vested/Issued, shares | (113,417) | |
Forfeited, shares | (229,681) | |
Nonvested shares, Ending balance | 2,274,100 | |
Weighted Average Grant-Date Fair Value | ||
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value | $ 27.63 | |
Granted, Weighted Average Grant-Date Fair Value | 10.74 | $ 28.69 |
Vested/Issued, Weighted Average Grant-Date Fair Value | 48.96 | |
Forfeited, Weighted Average Grant-Date Fair Value | 28.34 | |
Nonvested, Ending balance, Weighted Average Grant-Date Fair Value | $ 21.85 |
401(K) Savings Plan - Additiona
401(K) Savings Plan - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Employer matching contribution expenses | $ 0.4 | $ 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 ($) $ / shares in Units, shares in Millions | Mar. 02, 2020 | Jan. 29, 2019 | Mar. 31, 2020 |
Commitments And Contingencies Disclosure [Line Items] | |||
License agreement, expected milestone payment | $ 187,500,000 | ||
Owe a success-based legal fee to the company’s legal counsel | 3,000,000 | ||
Hsingching Hsu | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Accrued estimated losses | 9,100,000 | ||
Loss contingency damages awarded percent of total claim | 5.00% | ||
Loss contingency claimed damages awarded per share | $ 87.20 | ||
Number of shares traded to claim damages | 10 | ||
Legal fee, liability | 0 | ||
Hsingching Hsu | Minimum | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Percentage of stockholders sufficient to recover damages | 20.00% | ||
Amount of damages after claims | $ 9,000,000 | ||
Hsingching Hsu | Maximum | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Damages awarded per share | $ 4.50 | ||
Percentage of stockholders sufficient to recover damages | 40.00% | ||
Amount of damages after claims | $ 18,000,000 | ||
Eshelman v. Puma Biotechnology, Inc. | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Accrued estimated losses | 22,400,000 | ||
Attorneys fees | $ 3,000,000 | ||
Total judgment value | $ 26,300,000 | ||
Stand-by letter of credit, amount | 8,900,000 | ||
Eshelman v. Puma Biotechnology, Inc. | Compensatory | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Damages awarded, value | 15,900,000 | ||
Eshelman v. Puma Biotechnology, Inc. | Punitive | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Damages awarded, value | 6,500,000 | ||
Eshelman v. Puma Biotechnology, Inc. | Maximum | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Amount of damages after claims | $ 27,200,000 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event - USD ($) | Apr. 20, 2020 | Apr. 28, 2020 |
Bixink Agreement | Maximum | ||
Subsequent Event [Line Items] | ||
Upfront and milestone payments receivable | $ 6,000,000 | |
Paycheck Protection Program Loan | Silicon Valley Bank and Oxford Finance LLC | ||
Subsequent Event [Line Items] | ||
Proceeds from loan | $ 8,400,000 |