Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 15, 2019 | Jun. 29, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | PBYI | ||
Entity Registrant Name | PUMA BIOTECHNOLOGY, INC. | ||
Entity Central Index Key | 1,401,667 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 38,497,981 | ||
Entity Public Float | $ 1,999.8 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 108,419 | $ 81,698 |
Marketable securities | 57,002 | |
Accounts receivable, net | 20,773 | 9,670 |
Inventory | 2,625 | 2,029 |
Prepaid expenses, and other, current | 12,397 | 12,997 |
Other current assets | 1,787 | |
Total current assets | 203,003 | 106,394 |
Property and equipment, net | 3,963 | 4,470 |
Prepaid expenses and other, long-term | 3,429 | 1,989 |
Intangible assets, net | 44,408 | 48,355 |
Restricted cash | 4,319 | 4,317 |
Total assets | 259,122 | 165,525 |
Current liabilities: | ||
Accounts payable | 20,684 | 27,692 |
Accrued expenses | 46,431 | 30,648 |
Total current liabilities | 67,115 | 58,340 |
Deferred rent | 5,815 | 5,406 |
Long-term debt | 151,886 | 48,477 |
Total liabilities | 224,816 | 112,223 |
Stockholders' equity: | ||
Common stock - $.0001 par value per share; 100,000,000 shares authorized; 38,325,037 shares issued and outstanding at December 31, 2018 and 37,594,851 issued and outstanding at December 31, 2017 | 4 | 4 |
Additional paid-in capital | 1,236,355 | 1,142,213 |
Receivable from exercise of stock options | (449) | |
Accumulated other comprehensive loss | (12) | |
Accumulated deficit | (1,202,041) | (1,088,466) |
Total stockholders' equity | 34,306 | 53,302 |
Total liabilities and stockholders' equity | $ 259,122 | $ 165,525 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
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 | 38,325,037 | 37,594,851 |
Common stock, shares outstanding | 38,325,037 | 37,594,851 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue: | |||
Total revenue | $ 250,991 | $ 27,685 | |
Operating costs and expenses: | |||
Cost of sales | 34,621 | 5,572 | |
Selling, general and administrative | 146,188 | 106,693 | $ 53,798 |
Research and development | 164,854 | 207,810 | 222,798 |
Total operating costs and expenses | 345,663 | 320,075 | 276,596 |
Loss from operations | (94,672) | (292,390) | (276,596) |
Other (expenses) income: | |||
Interest income | 1,796 | 1,256 | 958 |
Interest expense | (10,985) | (720) | |
Class action verdict expense | (9,000) | ||
Other expenses | (714) | (101) | (373) |
Total other (expenses) income: | (18,903) | 435 | 585 |
Net loss | (113,575) | (291,955) | (276,011) |
Net loss applicable to common stockholders | $ (113,575) | $ (291,955) | $ (276,011) |
Net loss per share of common stock—basic and diluted | $ (2.99) | $ (7.85) | $ (8.29) |
Weighted-average shares of common stock outstanding—basic and diluted | 37,942,411 | 37,169,678 | 33,295,114 |
Product Revenue, Net | |||
Revenue: | |||
Total revenue | $ 200,491 | $ 26,185 | |
License Revenue | |||
Revenue: | |||
Total revenue | $ 50,500 | $ 1,500 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (113,575) | $ (291,955) | $ (276,011) |
Other comprehensive loss | |||
Unrealized (loss) gain on available-for-sale securities | (12) | 13 | 134 |
Comprehensive loss | $ (113,587) | $ (291,942) | $ (275,877) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - 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, 2015 | $ 206,007 | $ 3 | $ 726,651 | $ (147) | $ (520,500) | |
Beginning Balance (in shares) at Dec. 31, 2015 | 32,466,842 | |||||
Stock-based compensation | 117,264 | 117,264 | ||||
Exercise of stock options | $ 576 | 576 | ||||
Exercises of stock options (in shares) | 43,751 | 46,668 | ||||
Issuance of common stock | $ 161,854 | $ 1 | 161,853 | |||
Issuance of common stock (in shares) | 4,312,500 | |||||
Unrealized loss on available-for-sale securities | 134 | 134 | ||||
Net loss | (276,011) | (276,011) | ||||
Ending Balance at Dec. 31, 2016 | 209,824 | $ 4 | 1,006,344 | (13) | (796,511) | |
Ending Balance (in shares) at Dec. 31, 2016 | 36,826,010 | |||||
Stock-based compensation | $ 108,735 | 108,735 | ||||
Exercises of stock options (in shares) | 557,080 | 557,080 | ||||
Shares issued or restricted stock units vested under employee stock plans | $ 26,685 | 27,134 | $ (449) | |||
Shares issued or restricted stock units vested under employee stock plans (in shares) | 768,841 | |||||
Unrealized loss on available-for-sale securities | 13 | 13 | ||||
Net loss | (291,955) | (291,955) | ||||
Ending Balance at Dec. 31, 2017 | $ 53,302 | $ 4 | 1,142,213 | (449) | (1,088,466) | |
Ending Balance (in shares) at Dec. 31, 2017 | 37,594,851 | 37,594,851 | ||||
Stock-based compensation | $ 86,939 | 86,939 | ||||
Exercises of stock options (in shares) | 200,743 | 200,743 | ||||
Shares issued or restricted stock units vested under employee stock plans | $ 7,652 | 7,203 | $ 449 | |||
Shares issued or restricted stock units vested under employee stock plans (in shares) | 730,186 | |||||
Unrealized loss on available-for-sale securities | (12) | (12) | ||||
Net loss | (113,575) | (113,575) | ||||
Ending Balance at Dec. 31, 2018 | $ 34,306 | $ 4 | $ 1,236,355 | $ (12) | $ (1,202,041) | |
Ending Balance (in shares) at Dec. 31, 2018 | 38,325,037 | 38,325,037 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) | Dec. 31, 2016$ / shares |
Statement Of Stockholders Equity [Abstract] | |
Issuance of common stock, per share | $ 40 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities: | |||
Net loss | $ (113,575) | $ (291,955) | $ (276,011) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 7,384 | 2,811 | 1,149 |
Built-out allowance received from landlord | 2,997 | ||
Stock-based compensation | 86,939 | 108,735 | 117,264 |
Disposal of leasehold improvements | 368 | ||
Debt modification fees | 289 | ||
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (11,103) | (9,670) | |
Inventory | (596) | (2,029) | |
Prepaid expenses and other | (840) | (1,142) | 3,413 |
Other current assets | (1,787) | ||
Accounts payable | (7,008) | 7,657 | 2,231 |
Accrued expenses | 15,783 | 13,222 | 2,787 |
Deferred rent | 409 | (99) | 4,112 |
Net cash used in operating activities | (24,105) | (172,470) | (141,690) |
Investing activities: | |||
Intangible assets | (50,000) | ||
Purchase of property and equipment | (439) | (431) | (4,287) |
Expenditures for leasehold improvements | (170) | (2,997) | |
Purchase of available-for-sale securities | (107,502) | (79,729) | (81,794) |
Sale/maturity of available-for-sale securities | 50,488 | 114,724 | 231,267 |
Net cash (used in) provided by investing activities | (57,623) | (15,436) | 142,189 |
Financing activities: | |||
Net proceeds from issuance of common stock | 161,854 | ||
Net proceeds from shares issued under employee stock plans | 7,652 | 26,685 | 576 |
Proceeds from long-term debt | 105,000 | 50,000 | |
Payment of debt issuance costs | (4,201) | (1,575) | |
Net cash provided by financing activities | 108,451 | 75,110 | 162,430 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 26,723 | (112,796) | 162,929 |
Cash, cash equivalents and restricted cash, beginning of period | 86,015 | 198,811 | 35,882 |
Cash, cash equivalents and restricted cash, end of period | 112,738 | 86,015 | $ 198,811 |
Supplemental disclosures of non-cash investing and financing activities: | |||
Property and equipment purchases in accounts payable | 27 | ||
Receivables related to stock option exercises | 449 | ||
Supplemental disclosure of cash flow information: | |||
Interest paid | $ 8,055 | $ 334 |
Business and Basis of Presentat
Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2018 | |
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 the global development and commercialization rights to three drug candidates—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. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. In November 2012, the Company established and incorporated Puma Biotechnology Ltd., a wholly owned subsidiary, for the sole purpose of serving as the Company’s legal representative in the United Kingdom and the European Union in connection with the Company’s clinical trial activity in those countries. Puma Biotechnology Ltd. is currently the holder of the marketing authorisation for commercialization of NERLYNX in the European Union. In December 2018, the Company established and incorporated Puma Biotechnology, B.V., a wholly owned subsidiary, for the sole purpose transferring the above mentioned marketing authorisation in preparation of the departure of the United Kingdom from the European Union. Basis of Presentation: The Company is focused on developing and commercializing neratinib for the treatment of patients with human epidermal growth factor receptor type 2, or HER2-positive, breast cancer, HER2 mutated non-small cell lung cancer, HER2-negative breast cancer that has a HER2 mutation and other solid tumors that have an activating mutation in HER2. The Company has reported a net loss of approximately $113.6 million and negative cash flows from operations of approximately $24.1 million for the year ended December 31, 2018. Management believes that the Company will continue to incur net losses and negative net cash flows from operating activities through the drug development process and global commercialization. The Company has incurred significant operating losses and negative cash flows from operations since its inception. On July 17, 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. The Company in-licenses PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357, as well as certain related compounds, Additionally, the Company has entered into exclusive license agreements with Specialised Therapeutics Asia Pte Ltd., or STA, Medison Pharma Ltd., or Medison, CANbridgepharma Limited, or CANbridge, and, most recently, Pint Pharma International SA, or Pint, to pursue regulatory approval and commercialize NERLYNX, if approved, in various specified regions outside of the United States. The Company plans to continue to pursue commercialization of NERLYNX in additional countries outside the United States, if approved, and is evaluating various commercialization options in those countries, including developing a direct salesforce, contracting with third parties to provide sales and marketing capabilities, or some combination of these two options. In September 2018, the European Commission, or EC, granted marketing authorisation for NERLYNX 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. Commercialization in the United States and in the European Union, may require funding in addition to the cash and cash equivalents totaling approximately $108.4 million and marketable securities totaling approximately $57.0 million available at December 31, 2018. The Company believes that its existing cash and cash equivalents and marketable securities as of December 31, 2018 and proceeds that will become available to the Company through product sales are sufficient to satisfy its operating cash and needs for at least one year after the filing of the Annual Report on Form 10-K in which these financial statements are included. The Company continues to remain dependent on its ability to obtain sufficient funding to sustain operations and continue to successfully commercialize neratinib in the United States and launch in the European Union. While the Company has been successful in raising capital in the past, there can be no assurance that it will be able to do so in the future. The Company’s ability to obtain funding may be adversely impacted by uncertain market conditions, unfavorable decisions of regulatory authorities or adverse clinical trial results. The outcome of these matters cannot be predicted at this time. Since its inception through December 31, 2018, 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 with Silicon Valley Bank, or SVB and Oxford Finance LLC, or The Company may need additional financing before it can achieve profitability, if ever. There can be no assurance that additional capital will be available on favorable terms or at all or that any additional capital that the Company is able to obtain will be sufficient to meet its needs. If it is unable to raise additional capital, the Company could likely be forced to curtail desired development activities, which will delay the development of its product candidates. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Note 2—Significant Accounting Policies: The significant accounting policies followed in the preparation of these consolidated financial statements are as follows: 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. Use of Estimates: The preparation of consolidated financial statements in conformity with 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 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. Principles of Consolidation: The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. 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 loss in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. 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. 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 $3.9 million for the year ended December 31, 2018. As of December 31, 2018, estimated future amortization expense related to the Company’s intangible asset was approximately $3.9 million for each year starting 2019 through 2029, and $1.0 million for 2030. Royalties: Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 12 Commitments and Contingencies, are expensed to cost of sales as revenue from product sales is recognized. 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. 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 and comprehensive loss. 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 as incurred. 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 sales and marketing expense as incurred. As of December 31, 2018, the Company’s inventory balance consisted primarily of raw materials purchased subsequent to FDA approval of NERLYNX. Revenue Recognition: The Company adopted Accounting Standards Codification, or ASC, Topic 606 – Revenue from Contracts with Customers, or Topic 606, on January 1, 2017. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements, and financial instruments. Under ASC Topic 606, an entity recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled in exchange for those goods or services. The Company had no contracts with customers until the FDA approved NERLYNX on July 17, 2017. Subsequent to receiving FDA approval, the Company entered into a limited number of arrangements with specialty pharmacies and specialty distributors in the United States to distribute NERLYNX. These arrangements are the Company’s initial contracts with customers. The Company has determined that these sales channels with customers are similar. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC Topic 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 Topic 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 Topic 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 year ended December 31, 2018. Product revenue from each of our customers who individually accounted for 10% or more of total revenues consisted of the following: For the Year Ended December 31, 2018 CVS/Caremark 39 % Accredo/Acaria 25 % Diplomat 13 % License Revenue: The Company also recognizes license revenue under certain of the Company’s sub-license agreements that are within the scope of ASC Topic 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 Topic 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. During the first quarter of 2018, the Company entered into a sub-licensing agreement with CANbridge, to pursue regulatory approval and commercialize NERLYNX, if approved, in the People’s Republic of China (including mainland China, Hong Kong, Macao, and Taiwan). This agreement granted intellectual property rights and set forth the parties’ respective obligations with respect to development, commercialization and supply of the licensed product. For the CANBridge license agreement, a non-refundable, an upfront license fee of $30 million was received and recognized as license revenue in accordance with ASC Topic 606. The license 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 CANBridge with the licensed product in accordance with the supply agreement entered in connection with the license agreement. This supply arrangement has been identified as a separate performance obligation. The Company also identified the Joint Steering Committee as a separate, distinct performance obligation. To determine the stand-alone selling price, 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 this agreement. Pursuant to the CANbridge Agreement, the Company will potentially receive additional regulatory milestone payments totaling up to $30 million and sales-based milestone payments totaling up to $185 million. In addition, the Company is entitled to receive significant double-digit royalties calculated as a percentage of net sales of the licensed products in the CANbridge Territory. During the fourth quarter of 2018, the Company received a $10 million payment from CANBridge in relation to the achievement of a regulatory milestone. The Company satisfied the necessary performance obligations to recognize this license revenue under the terms of the arrangement. Additionally, during the first quarter of 2018, the Company entered into a sub-license agreement with Pint. The license 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. This license agreement met the contract existence criteria and contained distinct, identifiable performance obligations for which the stand-alone selling prices were readily determinable and allocable. Under the terms of the license agreement, the Company was entitled to receive a non-deductible, non-creditable upfront payment of $10 million 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 the necessary performance obligations to recognize the revenue under the terms of the arrangement. 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 were no significant financing components, noncash consideration, or consideration payable to the customer in these agreements. non-deductible, non-creditable 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 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 Topic 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 December 31, 2018 and, therefore, the transaction price was not reduced further during the year ended December 31, 2018. 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 trade 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 and comprehensive loss through December 31, 2018. 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 revenue in the period the related product revenue is recognized, as well as a reduction to trade 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 is established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by customers, and the Company generally issues payments for such amounts within a few weeks of the customer’s notification to the Company of the resale. Reserves for chargebacks consist of payments 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 and the establishment of a current liability, which is included in accrued expenses and other current liabilities 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 and the establishment of a current liability. 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 and other current liabilities on the consolidated balance sheets. Assets Measured at Fair Value on a Recurring Basis: ASC 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 December 31, 2018 and 2017, 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): December 31, 2018 Level 1 Level 2 Level 3 Total Cash equivalents $ 83,329 $ 2,987 $ — $ 86,316 Commercial paper — 35,941 — 35,941 Corporate bonds — 18,077 — 18,077 U.S. government securities 2,984 — — 2,984 $ 86,313 $ 57,005 $ — $ 143,318 December 31, 2017 Level 1 Level 2 Level 3 Total Cash equivalents $ 67,753 $ — $ — $ 67,753 $ 67,753 $ — $ — $ 67,753 The Company’s investments in commercial paper, corporate bonds and U.S. government securities are exposed to price fluctuations. The fair value measurements for commercial paper, corporate bonds and U.S. government securities are based upon the quoted prices of similar items in active markets multiplied by the number of securities owned. The cash equivalents balance previously disclosed in the footnotes of the Company’s 2017 Annual Report on Form 10-K of $81.7 million incorrectly included cash of $13.9 million. The Company has excluded cash from the $67.8 million cash equivalents balance as of December 31, 2017 as currently presented. The misstatement was not material to the previously-reported financial statements. The following tables summarize the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Estimated December 31, 2018 (in years) cost Gains Losses fair value Cash equivalents $ 86,316 $ — $ — $ 86,316 Commercial paper Less than 1 35,941 — — 35,941 Corporate bonds Less than 1 18,089 — (12 ) 18,077 U.S. government securities Less than 1 2,984 — — 2,984 $ 143,330 $ — $ (12 ) $ 143,318 Maturity Amortized Unrealized Estimated December 31, 2017 (in years) cost Gains Losses fair value Cash equivalents $ 67,753 $ — $ — $ 67,753 $ 67,753 $ — $ — $ 67,753 Concentration of Risk: Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents and accounts receivable. The Company’s cash and cash equivalents and restricted cash in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at December 31, 2018, were approximately $112.7 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 trade receivables and net product revenues. 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 our customers, historical payment patterns, aging of receivable balances and general economic conditions. The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product 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’s success depends on its ability to effectively commercialize NERLYNX. 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. Research and Development Expenses: Research and development expenses, or R&D, are charged to operations as incurred. The major components of research and development costs include clinical manufacturing costs, clinical trial expenses, consulting and other third-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 capita |
Prepaid Expenses and Other
Prepaid Expenses and Other | 12 Months Ended |
Dec. 31, 2018 | |
Banking And Thrift [Abstract] | |
Prepaid Expenses and Other | Note 3—Prepaid Expenses and Other: Prepaid expenses and other consisted of the following at December 31 (in thousands): December 31, 2018 December 31, 2017 Current: CRO services $ 5,824 $ 7,188 Other clinical development 888 878 Insurance 2,446 1,306 Other 3,239 3,625 12,397 12,997 Long-term: CRO services 1,073 860 Other clinical development 650 886 Insurance 14 26 Other 1,692 217 3,429 1,989 Totals $ 15,826 $ 14,986 Other prepaid amounts consist primarily of deposits, licenses, subscriptions, software, and professional fees |
Other Current Assets
Other Current Assets | 12 Months Ended |
Dec. 31, 2018 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Other Current Assets | Note 4—Other Current Assets: Other current assets consisted of the following at December 31 (in thousands): December 31, 2018 December 31, 2017 Insurance receivable $ 1,175 $ — Other 612 $ — Totals $ 1,787 $ — Other current asset amounts consist primarily of insurance reimbursements related to the class action lawsuit that was still ongoing at December 31, 2018, and a tenant improvement receivable. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | Note 5—Property and Equipment: Property and equipment consisted of the following at December 31 (in thousands): December 31, 2018 December 31, 2017 Property and Equipment: Leasehold improvements $ 4,048 $ 3,878 Computer equipment 2,402 2,147 Telephone equipment 343 302 Furniture and fixtures 2,346 2,206 9,139 8,533 Less: accumulated depreciation (5,176 ) (4,063 ) Totals $ 3,963 $ 4,470 |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Note 6—Intangible Assets: Intangible assets consisted of the following at December 31 (in thousands): December 31, 2018 Estimated useful life Acquired and in-licensed rights $ 50,000 13 Years Less: accumulated amortization (5,592 ) Total intangible asset, net $ 44,408 Estimated future intangible amortization expense as of December 31, 2018 is as follows (in thousands): 2019 3,947 2020 3,947 2021 3,947 2022 3,947 Thereafter 28,620 Total $ 44,408 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Note 7—Accrued Expenses: Accrued expenses consisted of the following at December 31 (in thousands): December 31, 2018 December 31, 2017 Accrued CRO services 10,187 $ 8,335 Accrued royalties 9,162 3,922 Accrued class action verdict costs 9,000 — Accrued variable consideration 3,818 1,425 Accrued bonus 1,705 3,376 Accrued compensation 4,435 2,797 Accrued legal fees 1,379 2,046 Accrued other clinical development 2,380 3,438 Other 4,365 5,309 Totals $ 46,431 $ 30,648 Accrued CRO services, accrued other clinical development expenses, and accrued legal fees represent the Company’s estimates of such costs. Accrued compensation includes sales commissions and vacation. Accrued royalties represent royalties incurred in connection with the Company’s license agreement with Pfizer. Vacation 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 net revenue for which reserves are established. Accrued class action verdict costs represent an initial estimate of potential amounts that may be owed to class action participants as a result of the recent jury verdict in Hsu v. Puma Biotechnology, Inc., et al All accrued expenses are adjusted in the period the actual costs become known. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt | Note 8—Debt: Long term debt consisted of the following at December 31, 2018 (in thousands): December 31, 2018 Maturity Date Long term debt $ 155,000 May 1, 2023 Accretion of final interest payment 1,330 Less: deferred financing costs (4,444 ) Total long term debt, net $ 151,886 In October 2017, the Company entered into a loan and security agreement with SVB, as administrative agent, and the lenders party thereto from time to time, including Oxford and SVB. Pursuant to the terms of the credit facility provided for by the loan and security agreement, the Company borrowed $50.0 million. In May 2018, the Company entered into an amendment to the loan and security agreement. Under the amended credit facility, the 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 to under the credit facility as a result of achieving a specified minimum revenue milestone. Proceeds from the term loans under the amended credit facility may be used for working capital and general business purposes. Upon entry into the amended credit facility, the Company was required to pay the lenders aggregate fees of $4.2 million, consisting of a first amendment facility fee of $0.4 million and a final payment of $3.8 million in connection with the repayment of the $50.0 million borrowed under the original credit facility. The amended 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 subsidiary, Puma Biotechnology Ltd. The term loans under the amended credit facility bear 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 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 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 will make consecutive equal monthly payments of principal, together with applicable interest, in arrears to each lender, calculated pursuant to the amended credit facility. All unpaid principal and accrued and unpaid interest with respect to each term loan is due and payable in full on May 1, 2023. Upon repayment of the term loans, the Company is also required to make a final payment to the lenders equal to 7.5% of the original principal amount of term loans funded. 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 any 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 May 1, 2023. The amended credit facility includes affirmative and negative covenants applicable to the Company, its current subsidiary 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 product revenue, measured as of the last day of each fiscal quarter on a trailing 3-month basis, that is (i) greater than or equal to 70% of the Company’s revenue target set forth in its board-approved projections for the 2018 fiscal year and (ii) greater than or equal to 50% of the Company’s revenue target set forth in its board-approved projections for the 2019 fiscal year. New minimum revenue levels will be established for each subsequent fiscal year by mutual agreement of the Company, SVB as administrative agent, and the lenders. 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 amended 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 SVB, as collateral agent, with the right to exercise remedies against the Company and the collateral securing the amended credit facility, including foreclosure against the property securing the credit facilities, including its cash. These events of default include, among other things, the Company’s failure to pay principal or interest due under the amended credit facility, a breach of certain covenants under the amended credit facility, the Company’s insolvency, a material adverse change, the occurrence of any default under certain other indebtedness in an amount greater than $0.5 million and one or more judgments against the Company in an amount greater than $0.5 million individually or in the aggregate. As of December 31, 2018, there was $155 million in term loans outstanding under the amended credit facility, and the Company was in compliance with all applicable covenants under the amended credit facility. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | Note 9—Stockholders’ Equity: Common Stock: October 2016 Common Stock Offering. On October 19, 2016, the Company entered into an underwriting agreement in connection with the public offering, issuance and sale by the Company of 3,750,000 shares of the Company’s common stock, par value $0.0001 per share, at a public offering price of $40.00 per share, less underwriting discounts and commissions. Under the terms of the underwriting agreement, the Company also granted the underwriters an option exercisable for 30 days to purchase up to an additional 562,500 shares of its common stock at the public offering prices, less underwriting discounts and commissions. On October 20, 2016, the underwriters exercised their option to purchase additional shares in full. The Company received net proceeds from the offering of approximately $161.9 million, after deducting underwriting discounts and commissions and estimated offering expenses. The Company issued 200,743, 557,080, and 46,668 shares of common stock upon exercise of stock options during the years ended December 31, 2018, 2017 and 2016, respectively. The Company issued 529,443, 211,761, and 2,917 shares of common stock upon vesting of RSUs during the years ended December 31, 2018, 2017 and 2016, respectively. Authorized Shares: The Company has 100,000,000 shares of stock authorized for issuance, all of which 100,000,000 are common stock, par value $0.0001 per share. Warrants: In October 2011, the Company issued an anti-dilutive warrant to Alan Auerbach, the Company’s founder and chief executive officer. The warrant was issued to provide Mr. Auerbach with the right to maintain ownership of at least 20% of the Company’s common stock in the event that the Company raised capital through the sale of its securities in the future. In connection with the closing of a public offering in October 2012, the exercise price and number of shares underlying the warrant issued to Mr. Auerbach were established and, accordingly, the final value of the warrant became fixed. Pursuant to the terms of the warrant, Mr. Auerbach may exercise the warrant to acquire 2,116,250 shares of the Company’s common stock at $16 per share until October 4, 2021 Stock Options and Restricted Stock Units: The Company’s 2011 Incentive Award Plan, 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. The exercise price of incentive stock options granted under the 2011 Plan must be at least equal to the fair value of such shares on the date of grant. Through December 31, 2018, a total of 12,529,412 shares of the Company’s common stock have been reserved for issuance under the 2011 Plan. The Company awarded only “plain vanilla options” as determined by the SEC Staff Accounting Bulletin 107, or Share Based Payment 2018 2017 Dividend yield 0.0 % 0.0 % Expected volatility 96.5 % 70.2 % Risk-free interest rate 2.7 % 2.0 % Expected life in years 5.85 5.83 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 restricted stock units, 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. The exercise price of stock options granted under the 2017 Plan must be at least equal to the fair market value of such shares on the date of grant. As of December 31, 2018, a total of 1,000,000 shares of the Company’s common stock have been reserved for issuance under the 2017 Plan. As of December 31, 2018, 371,335 shares have been awarded under the 2017 Plan. Employee stock-based compensation expense was as follows for the years ended December 31 (in thousands except per share data): For the Year Ended December 31, 2018 2017 2016 Stock-based compensation: Options - Research and development $ 26,456 $ 67,299 $ 88,049 Selling, general and administrative 14,063 23,024 25,043 Performance shares - R&D — — (528 ) Restricted stock units - Selling, general and administrative 20,851 8,170 1,580 Research and development 25,569 10,242 3,120 Total stock-based compensation expense $ 86,939 $ 108,735 $ 117,264 Activity with respect to options granted under the 2011 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, 2015 5,542,285 $ 105.59 8.6 $ 87,632 Granted 1,658,465 $ 42.34 9.3 Forfeited (446,544 ) $ 122.50 Exercised (43,751 ) $ 13.16 $ 1,360 Expired (131,933 ) $ 185.10 Outstanding at December 31, 2016 6,578,522 $ 87.52 8.0 $ 18,442 Granted 519,791 $ 38.87 8.4 Forfeited (285,377 ) $ 50.11 Exercised (557,080 ) $ 48.71 $ 27,185 Expired (121,343 ) $ 125.40 Outstanding at December 31, 2017 6,134,513 $ 87.91 7.2 $ 220,060 Granted 315,566 $ 59.13 9.3 Forfeited (183,837 ) $ 51.96 Exercised (200,743 ) $ 35.88 $ 5,063 Expired (356,955 ) $ 116.96 Outstanding at December 31, 2018 5,708,544 $ 87.49 6.1 $ 7,762 Nonvested at December 31, 2018 779,292 $ 48.97 8.5 — Exercisable 4,929,252 $ 93.58 5.7 $ 7,762 At December 31, 2018, total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $20.8 million, which is expected to be recognized over a weighted-average period of 1.5 years. At December 31, 2018, the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $87.9 million, which is expected to be recognized over a weighted-average period of 2.0 years. The weighted-average grant date fair value of options granted during the years ended December 31, 2018, 2017 and 2016, was $45.62, $24.30 and $25.69 per share, respectively. The weighted average grant date fair value of RSUs awarded during the year ended December 31, 2018, 2017 and 2016 was $41.42, $94.93, and $54.35, respectively. Weighted Average Grant-Date Stock options Shares Fair Value Nonvested shares at December 31, 2016 3,106,083 $ 47.78 Granted 519,791 24.30 Vested/Issued (1,552,061 ) 59.76 Forfeited (285,377 ) 30.21 Nonvested shares at December 31, 2017 1,788,436 33.37 Granted 315,566 45.62 Vested/Issued (1,140,873 ) 36.81 Forfeited (183,837 ) 31.43 Nonvested shares at December 31, 2018 779,292 $ 33.75 Weighted Average Grant-Date Restricted stock units Shares Fair Value Nonvested shares at December 31, 2016 630,508 $ 54.35 Granted 1,277,081 94.93 Vested/Issued (211,761 ) 55.17 Forfeited (58,166 ) 63.02 Nonvested shares at December 31, 2017 1,637,662 85.58 Granted 1,175,231 41.42 Vested/Issued (529,443 ) 79.98 Forfeited (444,780 ) 80.99 Nonvested shares at December 31, 2018 1,838,670 $ 60.08 |
401(k) Savings Plan
401(k) Savings Plan | 12 Months Ended |
Dec. 31, 2018 | |
Postemployment Benefits [Abstract] | |
401(k) Savings Plan | Note 10—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 $1.9 million, $0.9 million and $ 1.0 million for the years ended December 31, 2018, 2017 and 2016, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 11—Income Taxes: On December 22, 2017, H.R. 1/Public Law No. 115-97 known as the Tax Cuts and Jobs Act, or the Tax Act, was signed into law. The effects of this new federal legislation are recognized upon enactment, which is the date a bill is signed into law. The Tax Act includes numerous changes in existing tax law, including a permanent reduction in the federal corporate income tax rate from 35% (as the top corporate tax rate) to 21%, limitations on executive compensation and deductibility of interest expense. The Company has revalued its net deferred tax assets as of December 31, 2017 to reflect the rate reduction. As of December 31, 2018 the Company calculated an approximate $4.6 million limitation on executive compensation deduction pursuant to IRC section 162(m) and an approximate $9.2 million limitation on interest expense pursuant to IRC section 162(j). Pursuant to the SEC Staff Accounting Bulletin No. 118, "Income Tax Accounting Implications of the Tax Cuts and Jobs Act,” or SAB 118, a company may select between one of three scenarios to determine a reasonable estimate arising from the Tax Act. Those scenarios are (i) a final estimate which effectively closes the measurement window; (ii) a reasonable estimate leaving the measurement window open for future revisions; and (iii) no estimate as the law is still being analyzed. The Company recognized an adjustment of $141.1 million in the period ending December 31, 2017, which was offset by a full valuation allowance. Other impacts of the Tax Act including, but not limited to, a limitation of the deduction for net operating losses and additional limitations on the deductibility of executive compensation and interest expense are not expected to have a material impact to the financial statement presentation as the company records has historically generated tax losses and in a full valuation allowance. The Company’s review of the final impact of the Tax Act may be different from certain provisional amounts reported due to changes in interpretations and assumptions of the current guidance available as well as the issuance of new regulatory guidance in the future. As of December 31, 2018, we have completed our accounting for the tax effects of the 2017 Tax Act and did not identify any measurement period adjustments related to SAB 118. The Company’s provision for income taxes for the year ended December 31, 2018 is $17,000 and did not have any provisions for income taxes for the years ended December 31, 2017 and 2016. (in thousands) 2018 2017 2016 Current: Federal $ — $ — $ — State 17 — — $ 17 $ — $ — Deferred: Federal — — — State — — — $ — $ — $ — Total $ 17 $ — $ — The provision (credit) for income taxes in the accompanying Consolidated Statements of Operations differs from the amount calculated by applying the statutory income tax rate to income (loss) from continuing operations before income taxes. Approximately $15.8 million was recorded by the Company as a prior period adjustment. The majority of this adjustment comes from a change in the state blended rate and state tax return to provision adjustments. These state tax adjustments are due to the Company performing a nexus study which resulted in 36 additional required state filings and true-up of the state tax net operating loss. The primary components of such differences are as follows as of December 31 (in thousands): 2018 2017 2016 Tax computed at the federal statutory rate $ (23,771 ) $ (99,234 ) $ (93,839 ) State taxes (2,791 ) (15,890 ) (15,693 ) Permanent items 10,932 (1,404 ) 6,152 R&D credits (5,630 ) (6,217 ) (2,728 ) Deferred tax asset adjustment — 6,805 — Other — (20 ) (113 ) Impact of federal statutory rate change related to the 2017 Tax Act — 141,147 — Prior year adjustments 15,750 — — Change in valuation allowance 5,527 (25,187 ) 106,221 Total provision $ 17 $ — $ — Temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes give rise to the Company’s deferred income taxes. The components of the Company’s net deferred tax assets as of December 31, 2018 and 2017 are as follows (in thousands): 2018 2017 Deferred tax assets–2018: Net operating loss carry forwards $ 257,021 $ 257,121 Business credit carry forwards 35,107 29,695 Organization costs 3,593 180 Compensation 72,804 76,423 Deferred rent - leasehold improvement 1,404 680 Other — 806 Subtotal 369,929 364,905 Deferred tax liabilities (255 ) (758 ) Total deferred tax assets 369,674 364,147 Valuation allowance (369,674 ) (364,147 ) Net deferred tax assets $ — $ — As the ultimate realization of the potential benefits of the Company’s deferred tax assets is considered unlikely by management, the Company has offset the deferred tax assets attributable to those potential benefits through valuation allowances. Accordingly, the Company did not recognize any benefit from income taxes in the accompanying Consolidated Statements of Operations to offset its pre-tax losses. The valuation allowance increased $5.5 million and $48.1 million for the years ended December 31, 2018 and 2017, respectively. At December 31, 2018, the Company had federal and state net operating loss carryforwards respectively of approximately $948.5 million and $863.9 million, which will begin to expire in 2028 and 2031. At December 31, 2018, the Company also has federal research and development credit carryforwards of approximately $23.2 million. If not utilized, the carryforwards will begin expiring in 2032. The Company has state research and development credit carryforwards of approximately $11.9 million which do not expire. Pursuant to the Internal Revenue Code, Sections 382 and 383, use of the Company’s net operating loss and credit carryforwards could be limited if a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has not yet performed an assessment on the potential limitation on net operating loss and credit carryforwards. The following is a tabular reconciliation of the total amounts of unrecognized tax benefits at December 31: 2018 2017 2016 Unrecognized tax benefits $ 7,151 $ 5,315 $ 4,475 Gross decreases-tax positions in prior period Gross increases - tax positions in a current period 1,626 1,836 840 Unecognized tax benefits - December 31 8,777 $ 7,151 $ 5,315 The unrecognized tax benefits that, if recognized, would affect the effective tax rate is $8.8 million at December 31, 2018. The Company does not have tax positions for which it is reasonably possible that the total amounts of unrecognized tax benefit will significantly increase or decrease within 12 months of the reporting date. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by the federal and state jurisdictions where applicable. There are currently no pending income tax examinations. The Company’s tax years for 2008 and forward are subject to examination by the federal and California tax authorities due to the carryforward of unutilized net operating losses and research and development credits. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 12—Commitments and Contingencies: Office Leases: In December 2011, the Company entered into a non-cancelable operating lease for office space in Los Angeles, California, which lease 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, and rent amounts payable by the Company increase approximately 3% per year. Concurrent with the execution of the lease, the Company provided the landlord an automatically renewable stand-by letter of credit in the amount of $2.5 million. The stand-by letter of credit is collateralized by a high-yield savings account which is classified as restricted cash on the accompanying Consolidated Balance Sheets. In June 2012, the Company entered into a long-term lease agreement for office space in South San Francisco, California, which was subsequently amended in May 2014 and July 2015. As amended, the Company rents approximately 29,470 square feet. The term of this lease runs until March 2026, and rents payable by the Company increase approximately 3% per year. The Company provided the landlord an automatically renewable stand-by letter of credit in the amount of $1,591,400. The stand-by letter of credit is collateralized by a high-yield savings account which is classified as restricted cash on the accompanying Consolidated Balance Sheets. Rent expense for the years ended December 31, 2018, 2017, and 2016, was approximately $4.7 million, $3.9 million and $3.5 million, respectively. Future minimum lease payments for each of the years subsequent to December 31, 2018, are as follows (in thousands): Year Ending December 31, Amount 2019 4,924 2020 5,141 2021 5,300 2022 5,464 Thereafter 18,927 Total 39,756 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 the Licensor’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. 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. Clinical Trial Contracts: The Company engages with clinical research organizations and contract manufacturing organizations, or CMOs, in addition to engaging in contracts for the management of its ongoing clinical trials and pre-commercialization efforts. The Company may cancel these agreements with a 30 to 45 day written notice to the outside vendor. The Company would be obligated to pay for services rendered up to that point. The contracts also contain variable costs that are hard to predict as they are based on such things as patients enrolled and clinical trial sites, which can vary and therefore, are not included in the table below. The contracts held by the Company as of December 31, 2018, are summarized as follows (in thousands): Indication Estimated Contractual Obligation as of December 31, 2018 Months Remaining on Contract HER2 Overexpressed/Amplified Breast Cancer (Extension) $ 11,690 15 HER2 Overexpressed/Amplified Breast Cancer (Licensor Legacy Clinical Trials) 1,191 8 HER2 Mutated Breast Cancer and HER2 Mutated Breast Cancer with Brain Mets 109 36 Metastatic & Adjuvant Breast Cancer 25,618 10 Neoadjuvant Breast Cancer 779 6 Preclinical Research 6,838 13 HER2 Mutated Solid Tumors 14,602 14 Other 34,914 20 Total 95,741 Included in the above are payments to be made when milestones are reached. As of December 31, 2018, Company obligations for potential milestone payments totaled approximately $27.2 Legal Proceedings The Company and certain of our executive officers were named as defendants in the lawsuits detailed below. Due to the stage of these proceedings, the Company cannot reasonably predict the outcome, nor can it estimate the amount of loss or range of loss, if any, that may result. 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. 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. The consolidated complaint alleges that the Company and certain of the Company’s executive officers made false or misleading statements and failed to disclose material adverse facts about its business, operations, prospects and performance in violation of Sections 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Exchange Act. The plaintiff sought damages, interest, costs, attorneys' fees, and other unspecified equitable relief. On July 10, 2018, the Company and two of its executive officers filed a motion for summary judgment seeking judgment in their favor on all claims. At the same time, the lead plaintiff filed its own motion for summary judgment, seeking judgment in favor on some, but not all, of its claims. The motions were heard in September 2018. The court granted the parties’ motions in part and denied them in part. Among the determinations by the court, the court granted summary judgment in favor of defendant Charles Eyler, the Company’s former Senior Vice President, Finance and Administration and Treasurer, and dismissed the claims against him. The court also granted summary judgment in defendants’ favor with respect to certain statements alleged by the plaintiff to include false or misleading statements. A trial on the remaining claims, which was initially set for November 6, 2018, was held from January 15, 2019 to January 29, 2019 on the court’s own motion. At trial, the jury found that one of the four remaining challenged statements was false or misleading, and awarded $4.50 per share in damages, which represents approximately 5% of the total claimed damages of $87.20 per share. The total amount of aggregate class-wide damages is uncertain and will be ascertained only after an extensive claims process and the exhaustion of any appeals. 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 million to $18 million. It is also reasonably possible that the total damages will be higher than this estimate, however, at this time, the amount is not estimable. A final judgment has not been entered. Eshelman vs. 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 alleges that Mr. Auerbach and the Company made defamatory statements regarding Dr. Eshelman in connection with a proxy contest. Dr. Eshelman seeks compensatory and punitive damages and expenses and costs, including attorneys’ fees. In April 2016, the Company filed a motion to dismiss the complaint, and in May 2016, Dr. Eshelman filed a notice of voluntary dismissal of the claims against Mr. Auerbach. In May 2017, the court denied the Company’s motion to dismiss. Discovery ended in September 2017. In September 2018, the court denied the Company’s motion for summary judgment and granted in part and denied in part Dr. Eshelman’s motion for partial summary judgment. This matter is set for trial beginning March 11, 2019. The Company intends to vigorously defend against Dr. Eshelman’s claims. Derivative Actions On April 12 and April 14, 2016, purported stockholders filed two derivative lawsuits purportedly on behalf of the Company against certain of the Company’s officers and directors in the Superior Court of the State of California, Los Angeles, captioned Xie Auerbach McKenney Auerbach Separately, on February 9, 2018, another purported stockholder filed a derivative lawsuit purportedly on behalf of the Company against certain of our officers and directors in the United States District Court, Central District of California, captioned Van Der Gracht De its Auerbach On May 30, 2018, another stockholder filed a derivative lawsuit purportedly on behalf of the Company against certain of its officers and directors in the United States District Court, Central District of California, captioned Duran vs. Auerbach On July 30, 2018, the parties reached a settlement in principle of the Xie Rommerswael Duran Rommerswael Xie Duran |
Quarterly Financial Data
Quarterly Financial Data | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data | Note 13—Quarterly Financial Data: Quarterly financial data (in thousands except share and per share data): (unaudited) Three Months Ended March 31, June 30, September 30, December 31, 2018 Revenues $ 66,516 $ 50,767 $ 62,629 $ 71,079 Net loss (24,345 ) (44,335 ) (14,201 ) (30,694 ) Net loss attributable to common stock (24,345 ) (44,335 ) (14,201 ) (30,694 ) Net loss per share—basic and diluted $ (0.65 ) $ (1.17 ) $ (0.37 ) $ (0.80 ) Weighted-average shares of common stock outstanding—basic and diluted 37,699,024 37,819,767 38,043,174 38,201,056 2017 Revenues $ — $ — $ 6,077 $ 21,608 Net loss 72,865 77,832 77,180 64,078 Net loss attributable to common stock 72,865 77,832 77,180 64,078 Net loss per share—basic and diluted $ 1.97 $ 2.10 $ 2.07 $ 1.71 Weighted-average shares of common stock outstanding—basic and diluted 36,931,167 36,992,017 37,214,002 37,534,410 2016 Revenues $ — $ — $ — $ — Net loss (70,972 ) (66,597 ) (65,781 ) (72,661 ) Net loss attributable to common stock (70,972 ) (66,597 ) (65,781 ) (72,661 ) Net loss per share—basic and diluted $ (2.19 ) $ (2.05 ) $ (2.02 ) $ (2.04 ) Weighted-average shares of common stock outstanding—basic and diluted 32,478,408 32,493,092 32,497,168 35,694,193 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 14—Subsequent Events: Knight Agreement On January 9, 2019, the Company entered into a license agreement, or the Knight Agreement, with Knight. Pursuant to the Knight Agreement, the Company granted to Knight, under certain of the Company’s intellectual property rights relating to neratinib, an exclusive, sublicensable (under certain circumstances) license (i) to commercialize any product containing neratinib and certain related compounds in Canada, or the Knight Territory, (ii) to seek and maintain regulatory approvals for the licensed products in the Knight Territory and (iii) to manufacture the licensed products anywhere in the world solely for the development and commercialization of the licensed products in the Knight Territory for human use, subject to the terms of the Knight Agreement and a supply agreement to be negotiated and executed by the parties. Pursuant to the Knight Agreement, the Company will receive upfront and milestone payments up to $7.2 million, each milestone payment payable upon the achievement of the milestone event specified in the Knight 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 Knight Territory. Hsu vs. Puma Biotechnology, Inc., et al. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
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. |
Use of Estimates | Use of Estimates: The preparation of consolidated financial statements in conformity with 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 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. |
Principles of Consolidation | Principles of Consolidation: The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. |
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 loss in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. 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. |
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 $3.9 million for the year ended December 31, 2018. As of December 31, 2018, estimated future amortization expense related to the Company’s intangible asset was approximately $3.9 million for each year starting 2019 through 2029, and $1.0 million for 2030. |
Royalties | Royalties: Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 12 Commitments and Contingencies, are expensed to cost of sales as revenue from product sales is recognized. |
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. 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 and comprehensive loss. 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 as incurred. 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 sales and marketing expense as incurred. As of December 31, 2018, the Company’s inventory balance consisted primarily of raw materials purchased subsequent to FDA approval of NERLYNX. |
Revenue Recognition | Revenue Recognition: The Company adopted Accounting Standards Codification, or ASC, Topic 606 – Revenue from Contracts with Customers, or Topic 606, on January 1, 2017. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements, and financial instruments. Under ASC Topic 606, an entity recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled in exchange for those goods or services. The Company had no contracts with customers until the FDA approved NERLYNX on July 17, 2017. Subsequent to receiving FDA approval, the Company entered into a limited number of arrangements with specialty pharmacies and specialty distributors in the United States to distribute NERLYNX. These arrangements are the Company’s initial contracts with customers. The Company has determined that these sales channels with customers are similar. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC Topic 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 Topic 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 Topic 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 year ended December 31, 2018. Product revenue from each of our customers who individually accounted for 10% or more of total revenues consisted of the following: For the Year Ended December 31, 2018 CVS/Caremark 39 % Accredo/Acaria 25 % Diplomat 13 % License Revenue: The Company also recognizes license revenue under certain of the Company’s sub-license agreements that are within the scope of ASC Topic 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 Topic 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. During the first quarter of 2018, the Company entered into a sub-licensing agreement with CANbridge, to pursue regulatory approval and commercialize NERLYNX, if approved, in the People’s Republic of China (including mainland China, Hong Kong, Macao, and Taiwan). This agreement granted intellectual property rights and set forth the parties’ respective obligations with respect to development, commercialization and supply of the licensed product. For the CANBridge license agreement, a non-refundable, an upfront license fee of $30 million was received and recognized as license revenue in accordance with ASC Topic 606. The license 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 CANBridge with the licensed product in accordance with the supply agreement entered in connection with the license agreement. This supply arrangement has been identified as a separate performance obligation. The Company also identified the Joint Steering Committee as a separate, distinct performance obligation. To determine the stand-alone selling price, 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 this agreement. Pursuant to the CANbridge Agreement, the Company will potentially receive additional regulatory milestone payments totaling up to $30 million and sales-based milestone payments totaling up to $185 million. In addition, the Company is entitled to receive significant double-digit royalties calculated as a percentage of net sales of the licensed products in the CANbridge Territory. During the fourth quarter of 2018, the Company received a $10 million payment from CANBridge in relation to the achievement of a regulatory milestone. The Company satisfied the necessary performance obligations to recognize this license revenue under the terms of the arrangement. Additionally, during the first quarter of 2018, the Company entered into a sub-license agreement with Pint. The license 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. This license agreement met the contract existence criteria and contained distinct, identifiable performance obligations for which the stand-alone selling prices were readily determinable and allocable. Under the terms of the license agreement, the Company was entitled to receive a non-deductible, non-creditable upfront payment of $10 million 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 the necessary performance obligations to recognize the revenue under the terms of the arrangement. 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 were no significant financing components, noncash consideration, or consideration payable to the customer in these agreements. non-deductible, non-creditable 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 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 Topic 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 December 31, 2018 and, therefore, the transaction price was not reduced further during the year ended December 31, 2018. 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 trade 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 and comprehensive loss through December 31, 2018. 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 revenue in the period the related product revenue is recognized, as well as a reduction to trade 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 is established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by customers, and the Company generally issues payments for such amounts within a few weeks of the customer’s notification to the Company of the resale. Reserves for chargebacks consist of payments 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 and the establishment of a current liability, which is included in accrued expenses and other current liabilities 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 and the establishment of a current liability. 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 and other current liabilities on the consolidated balance sheets. |
Assets Measured at Fair Value on a Recurring Basis | Assets Measured at Fair Value on a Recurring Basis: ASC 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 December 31, 2018 and 2017, 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): December 31, 2018 Level 1 Level 2 Level 3 Total Cash equivalents $ 83,329 $ 2,987 $ — $ 86,316 Commercial paper — 35,941 — 35,941 Corporate bonds — 18,077 — 18,077 U.S. government securities 2,984 — — 2,984 $ 86,313 $ 57,005 $ — $ 143,318 December 31, 2017 Level 1 Level 2 Level 3 Total Cash equivalents $ 67,753 $ — $ — $ 67,753 $ 67,753 $ — $ — $ 67,753 The Company’s investments in commercial paper, corporate bonds and U.S. government securities are exposed to price fluctuations. The fair value measurements for commercial paper, corporate bonds and U.S. government securities are based upon the quoted prices of similar items in active markets multiplied by the number of securities owned. The cash equivalents balance previously disclosed in the footnotes of the Company’s 2017 Annual Report on Form 10-K of $81.7 million incorrectly included cash of $13.9 million. The Company has excluded cash from the $67.8 million cash equivalents balance as of December 31, 2017 as currently presented. The misstatement was not material to the previously-reported financial statements. The following tables summarize the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Estimated December 31, 2018 (in years) cost Gains Losses fair value Cash equivalents $ 86,316 $ — $ — $ 86,316 Commercial paper Less than 1 35,941 — — 35,941 Corporate bonds Less than 1 18,089 — (12 ) 18,077 U.S. government securities Less than 1 2,984 — — 2,984 $ 143,330 $ — $ (12 ) $ 143,318 Maturity Amortized Unrealized Estimated December 31, 2017 (in years) cost Gains Losses fair value Cash equivalents $ 67,753 $ — $ — $ 67,753 $ 67,753 $ — $ — $ 67,753 |
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 and accounts receivable. The Company’s cash and cash equivalents and restricted cash in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at December 31, 2018, were approximately $112.7 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 trade receivables and net product revenues. 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 our customers, historical payment patterns, aging of receivable balances and general economic conditions. The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product 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’s success depends on its ability to effectively commercialize NERLYNX. 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. |
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 research and development costs 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 718, Compensation-Stock Compensation Restricted stock units: Restricted stock units, or 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). Warrants: Warrants (refer to Note 9 for further details) granted to employees 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 740, Income Taxes, or ASC 740, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the consolidated financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. 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 December 31, 2018, the Company has established a reserve of 20% of its research and development (“R&D”) credit carryover balance. |
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. |
Net Loss per Common Share | Net Loss per Share of Common Stock: Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the periods presented, as required by ASC 260, Earnings per Share |
Recently Issued Accounting Standards | Recently Issued Accounting Standards: In January 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities In February 2016, the FASB issued ASU No. 2016-02, Leases In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows Topic 230 : Classification of Certain Cash Receipts and Cash Payments a consensus of the Emerging Issues Task Force In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows Topic 230 Restricted Cash |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Product Revenues from Customers | Product revenue from each of our customers who individually accounted for 10% or more of total revenues consisted of the following: For the Year Ended December 31, 2018 CVS/Caremark 39 % Accredo/Acaria 25 % Diplomat 13 % |
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 December 31, 2018 and 2017, 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): December 31, 2018 Level 1 Level 2 Level 3 Total Cash equivalents $ 83,329 $ 2,987 $ — $ 86,316 Commercial paper — 35,941 — 35,941 Corporate bonds — 18,077 — 18,077 U.S. government securities 2,984 — — 2,984 $ 86,313 $ 57,005 $ — $ 143,318 December 31, 2017 Level 1 Level 2 Level 3 Total Cash equivalents $ 67,753 $ — $ — $ 67,753 $ 67,753 $ — $ — $ 67,753 |
Summary of Short-term Investments | The following tables summarize the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Estimated December 31, 2018 (in years) cost Gains Losses fair value Cash equivalents $ 86,316 $ — $ — $ 86,316 Commercial paper Less than 1 35,941 — — 35,941 Corporate bonds Less than 1 18,089 — (12 ) 18,077 U.S. government securities Less than 1 2,984 — — 2,984 $ 143,330 $ — $ (12 ) $ 143,318 Maturity Amortized Unrealized Estimated December 31, 2017 (in years) cost Gains Losses fair value Cash equivalents $ 67,753 $ — $ — $ 67,753 $ 67,753 $ — $ — $ 67,753 |
Prepaid Expenses and Other (Tab
Prepaid Expenses and Other (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Banking And Thrift [Abstract] | |
Components of Prepaid Expenses and Other | Prepaid expenses and other consisted of the following at December 31 (in thousands): December 31, 2018 December 31, 2017 Current: CRO services $ 5,824 $ 7,188 Other clinical development 888 878 Insurance 2,446 1,306 Other 3,239 3,625 12,397 12,997 Long-term: CRO services 1,073 860 Other clinical development 650 886 Insurance 14 26 Other 1,692 217 3,429 1,989 Totals $ 15,826 $ 14,986 |
Other Current Assets (Tables)
Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Schedule of Other Current Assets | Other current assets consisted of the following at December 31 (in thousands): December 31, 2018 December 31, 2017 Insurance receivable $ 1,175 $ — Other 612 $ — Totals $ 1,787 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | Property and equipment consisted of the following at December 31 (in thousands): December 31, 2018 December 31, 2017 Property and Equipment: Leasehold improvements $ 4,048 $ 3,878 Computer equipment 2,402 2,147 Telephone equipment 343 302 Furniture and fixtures 2,346 2,206 9,139 8,533 Less: accumulated depreciation (5,176 ) (4,063 ) Totals $ 3,963 $ 4,470 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | Intangible assets consisted of the following at December 31 (in thousands): December 31, 2018 Estimated useful life Acquired and in-licensed rights $ 50,000 13 Years Less: accumulated amortization (5,592 ) Total intangible asset, net $ 44,408 |
Schedule of Estimated Future Intangible Amortization Expense | Estimated future intangible amortization expense as of December 31, 2018 is as follows (in thousands): 2019 3,947 2020 3,947 2021 3,947 2022 3,947 Thereafter 28,620 Total $ 44,408 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following at December 31 (in thousands): December 31, 2018 December 31, 2017 Accrued CRO services 10,187 $ 8,335 Accrued royalties 9,162 3,922 Accrued class action verdict costs 9,000 — Accrued variable consideration 3,818 1,425 Accrued bonus 1,705 3,376 Accrued compensation 4,435 2,797 Accrued legal fees 1,379 2,046 Accrued other clinical development 2,380 3,438 Other 4,365 5,309 Totals $ 46,431 $ 30,648 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Long Term Debt | Long term debt consisted of the following at December 31, 2018 (in thousands): December 31, 2018 Maturity Date Long term debt $ 155,000 May 1, 2023 Accretion of final interest payment 1,330 Less: deferred financing costs (4,444 ) Total long term debt, net $ 151,886 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Fair Value Options Weighted-Average Assumptions | The fair value of options granted to employees was estimated using the Black-Scholes Option Pricing Method (see Note 2) with the following weighted-average assumptions used during the years ended December 31 2018 2017 Dividend yield 0.0 % 0.0 % Expected volatility 96.5 % 70.2 % Risk-free interest rate 2.7 % 2.0 % Expected life in years 5.85 5.83 |
Employee Stock-based Compensation Expense | Employee stock-based compensation expense was as follows for the years ended December 31 (in thousands except per share data): For the Year Ended December 31, 2018 2017 2016 Stock-based compensation: Options - Research and development $ 26,456 $ 67,299 $ 88,049 Selling, general and administrative 14,063 23,024 25,043 Performance shares - R&D — — (528 ) Restricted stock units - Selling, general and administrative 20,851 8,170 1,580 Research and development 25,569 10,242 3,120 Total stock-based compensation expense $ 86,939 $ 108,735 $ 117,264 |
Activity with Respect to Options Granted | Activity with respect to options granted under the 2011 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, 2015 5,542,285 $ 105.59 8.6 $ 87,632 Granted 1,658,465 $ 42.34 9.3 Forfeited (446,544 ) $ 122.50 Exercised (43,751 ) $ 13.16 $ 1,360 Expired (131,933 ) $ 185.10 Outstanding at December 31, 2016 6,578,522 $ 87.52 8.0 $ 18,442 Granted 519,791 $ 38.87 8.4 Forfeited (285,377 ) $ 50.11 Exercised (557,080 ) $ 48.71 $ 27,185 Expired (121,343 ) $ 125.40 Outstanding at December 31, 2017 6,134,513 $ 87.91 7.2 $ 220,060 Granted 315,566 $ 59.13 9.3 Forfeited (183,837 ) $ 51.96 Exercised (200,743 ) $ 35.88 $ 5,063 Expired (356,955 ) $ 116.96 Outstanding at December 31, 2018 5,708,544 $ 87.49 6.1 $ 7,762 Nonvested at December 31, 2018 779,292 $ 48.97 8.5 — Exercisable 4,929,252 $ 93.58 5.7 $ 7,762 |
Stock Options | The weighted-average grant date fair value of options granted during the years ended December 31, 2018, 2017 and 2016, was $45.62, $24.30 and $25.69 per share, respectively. Weighted Average Grant-Date Stock options Shares Fair Value Nonvested shares at December 31, 2016 3,106,083 $ 47.78 Granted 519,791 24.30 Vested/Issued (1,552,061 ) 59.76 Forfeited (285,377 ) 30.21 Nonvested shares at December 31, 2017 1,788,436 33.37 Granted 315,566 45.62 Vested/Issued (1,140,873 ) 36.81 Forfeited (183,837 ) 31.43 Nonvested shares at December 31, 2018 779,292 $ 33.75 |
Restricted Stock Units | The weighted average grant date fair value of RSUs awarded during the year ended December 31, 2018, 2017 and 2016 was $41.42, $94.93, and $54.35, respectively. Weighted Average Grant-Date Restricted stock units Shares Fair Value Nonvested shares at December 31, 2016 630,508 $ 54.35 Granted 1,277,081 94.93 Vested/Issued (211,761 ) 55.17 Forfeited (58,166 ) 63.02 Nonvested shares at December 31, 2017 1,637,662 85.58 Granted 1,175,231 41.42 Vested/Issued (529,443 ) 79.98 Forfeited (444,780 ) 80.99 Nonvested shares at December 31, 2018 1,838,670 $ 60.08 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Income taxes | The Company’s provision for income taxes for the year ended December 31, 2018 is $17,000 and did not have any provisions for income taxes for the years ended December 31, 2017 and 2016. (in thousands) 2018 2017 2016 Current: Federal $ — $ — $ — State 17 — — $ 17 $ — $ — Deferred: Federal — — — State — — — $ — $ — $ — Total $ 17 $ — $ — |
Schedule of Income Tax Reconciliation | The provision (credit) for income taxes in the accompanying Consolidated Statements of Operations differs from the amount calculated by applying the statutory income tax rate to income (loss) from continuing operations before income taxes. Approximately $15.8 million was recorded by the Company as a prior period adjustment. The majority of this adjustment comes from a change in the state blended rate and state tax return to provision adjustments. These state tax adjustments are due to the Company performing a nexus study which resulted in 36 additional required state filings and true-up of the state tax net operating loss. The primary components of such differences are as follows as of December 31 (in thousands): 2018 2017 2016 Tax computed at the federal statutory rate $ (23,771 ) $ (99,234 ) $ (93,839 ) State taxes (2,791 ) (15,890 ) (15,693 ) Permanent items 10,932 (1,404 ) 6,152 R&D credits (5,630 ) (6,217 ) (2,728 ) Deferred tax asset adjustment — 6,805 — Other — (20 ) (113 ) Impact of federal statutory rate change related to the 2017 Tax Act — 141,147 — Prior year adjustments 15,750 — — Change in valuation allowance 5,527 (25,187 ) 106,221 Total provision $ 17 $ — $ — |
Components of Net Deferred Tax Assets | The components of the Company’s net deferred tax assets as of December 31, 2018 and 2017 are as follows (in thousands): 2018 2017 Deferred tax assets–2018: Net operating loss carry forwards $ 257,021 $ 257,121 Business credit carry forwards 35,107 29,695 Organization costs 3,593 180 Compensation 72,804 76,423 Deferred rent - leasehold improvement 1,404 680 Other — 806 Subtotal 369,929 364,905 Deferred tax liabilities (255 ) (758 ) Total deferred tax assets 369,674 364,147 Valuation allowance (369,674 ) (364,147 ) Net deferred tax assets $ — $ — |
Reconciliation of Unrecognized Tax Benefits | The following is a tabular reconciliation of the total amounts of unrecognized tax benefits at December 31: 2018 2017 2016 Unrecognized tax benefits $ 7,151 $ 5,315 $ 4,475 Gross decreases-tax positions in prior period Gross increases - tax positions in a current period 1,626 1,836 840 Unecognized tax benefits - December 31 8,777 $ 7,151 $ 5,315 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments | Future minimum lease payments for each of the years subsequent to December 31, 2018, are as follows (in thousands): Year Ending December 31, Amount 2019 4,924 2020 5,141 2021 5,300 2022 5,464 Thereafter 18,927 Total 39,756 |
Summary of Clinical Research Organization Contracts | The contracts also contain variable costs that are hard to predict as they are based on such things as patients enrolled and clinical trial sites, which can vary and therefore, are not included in the table below. The contracts held by the Company as of December 31, 2018, are summarized as follows (in thousands): Indication Estimated Contractual Obligation as of December 31, 2018 Months Remaining on Contract HER2 Overexpressed/Amplified Breast Cancer (Extension) $ 11,690 15 HER2 Overexpressed/Amplified Breast Cancer (Licensor Legacy Clinical Trials) 1,191 8 HER2 Mutated Breast Cancer and HER2 Mutated Breast Cancer with Brain Mets 109 36 Metastatic & Adjuvant Breast Cancer 25,618 10 Neoadjuvant Breast Cancer 779 6 Preclinical Research 6,838 13 HER2 Mutated Solid Tumors 14,602 14 Other 34,914 20 Total 95,741 |
Quarterly Financial Data (Table
Quarterly Financial Data (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data | Quarterly financial data (in thousands except share and per share data): (unaudited) Three Months Ended March 31, June 30, September 30, December 31, 2018 Revenues $ 66,516 $ 50,767 $ 62,629 $ 71,079 Net loss (24,345 ) (44,335 ) (14,201 ) (30,694 ) Net loss attributable to common stock (24,345 ) (44,335 ) (14,201 ) (30,694 ) Net loss per share—basic and diluted $ (0.65 ) $ (1.17 ) $ (0.37 ) $ (0.80 ) Weighted-average shares of common stock outstanding—basic and diluted 37,699,024 37,819,767 38,043,174 38,201,056 2017 Revenues $ — $ — $ 6,077 $ 21,608 Net loss 72,865 77,832 77,180 64,078 Net loss attributable to common stock 72,865 77,832 77,180 64,078 Net loss per share—basic and diluted $ 1.97 $ 2.10 $ 2.07 $ 1.71 Weighted-average shares of common stock outstanding—basic and diluted 36,931,167 36,992,017 37,214,002 37,534,410 2016 Revenues $ — $ — $ — $ — Net loss (70,972 ) (66,597 ) (65,781 ) (72,661 ) Net loss attributable to common stock (70,972 ) (66,597 ) (65,781 ) (72,661 ) Net loss per share—basic and diluted $ (2.19 ) $ (2.05 ) $ (2.02 ) $ (2.04 ) Weighted-average shares of common stock outstanding—basic and diluted 32,478,408 32,493,092 32,497,168 35,694,193 |
Business and Basis of Present_2
Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||||||||||||||
Net loss | $ (30,694) | $ (14,201) | $ (44,335) | $ (24,345) | $ 64,078 | $ 77,180 | $ 77,832 | $ 72,865 | $ (72,661) | $ (65,781) | $ (66,597) | $ (70,972) | $ (113,575) | $ (291,955) | $ (276,011) |
Net cash used in operating activities | (24,105) | (172,470) | $ (141,690) | ||||||||||||
Cash and cash equivalents | 108,419 | $ 81,698 | 108,419 | $ 81,698 | |||||||||||
Marketable securities | $ 57,002 | $ 57,002 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | |||||||
Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($)Country | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2018USD ($)Segmentshares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016shares | |
Significant Accounting Policies [Line Items] | |||||||||
Amortization expenses related to intangible assets | $ 3,900,000 | ||||||||
Estimated future amortization expense related to intangible assets, 2019 | $ 3,947,000 | 3,947,000 | |||||||
Estimated future amortization expense related to intangible assets, 2020 | 3,947,000 | 3,947,000 | |||||||
Estimated future amortization expense related to intangible assets, 2021 | 3,947,000 | 3,947,000 | |||||||
Estimated future amortization expense related to intangible assets, 2022 | 3,900,000 | 3,900,000 | |||||||
Estimated future amortization expense related to intangible assets, 2023 | 3,900,000 | 3,900,000 | |||||||
Estimated future amortization expense related to intangible assets, 2024 | 3,900,000 | 3,900,000 | |||||||
Estimated future amortization expense related to intangible assets, 2025 | 3,900,000 | 3,900,000 | |||||||
Estimated future amortization expense related to intangible assets, 2026 | 3,900,000 | 3,900,000 | |||||||
Estimated future amortization expense related to intangible assets, 2027 | 3,900,000 | 3,900,000 | |||||||
Estimated future amortization expense related to intangible assets, 2028 | 3,900,000 | 3,900,000 | |||||||
Estimated future amortization expense related to intangible assets, 2029 | 3,900,000 | 3,900,000 | |||||||
Estimated future amortization expense related to intangible assets, 2030 | 1,000,000 | 1,000,000 | |||||||
Research and development expense related to inventory | 4,500,000 | ||||||||
Incremental costs expenses | 0 | 0 | |||||||
Upfront license fee | 71,079,000 | $ 62,629,000 | $ 50,767,000 | $ 66,516,000 | $ 21,608,000 | $ 6,077,000 | 250,991,000 | $ 27,685,000 | |
Company obligations for potential milestone payments for CRO Contracts | 27,200,000 | 27,200,000 | |||||||
Cash and cash equivalents | 108,419,000 | 81,698,000 | 108,419,000 | 81,698,000 | |||||
Cash | 13,900,000 | 13,900,000 | |||||||
Cash equivalents | $ 67,800,000 | $ 67,800,000 | |||||||
Cash and cash equivalents and restricted cash in excess of insured limits | 112,700,000 | $ 112,700,000 | |||||||
Reserve for research and development (“R&D”) credit carryover balance | 20.00% | ||||||||
Number of segments | Segment | 1 | ||||||||
Anti-dilutive securities excluded from the calculation of diluted earnings per share | shares | 9,325,381 | ||||||||
ASU 2016-02 | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Increase in right-of-use assets | $ 30,000,000 | ||||||||
Increase in lease liabilities | $ 30,000,000 | ||||||||
Employee Stock Option | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Anti-dilutive securities excluded from the calculation of diluted earnings per share | shares | 5,708,544 | 6,134,513 | |||||||
Warrants | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Anti-dilutive securities excluded from the calculation of diluted earnings per share | shares | 2,116,250 | 2,116,250 | |||||||
Restricted Stock Units | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Anti-dilutive securities excluded from the calculation of diluted earnings per share | shares | 1,838,670 | 1,637,662 | |||||||
License Revenue | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Upfront license fee | $ 50,500,000 | $ 1,500,000 | |||||||
CANbridge Life Sciences | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Payment received in relation to the achievement of a regulatory milestone | 10,000,000 | ||||||||
CANbridge Life Sciences | License Revenue | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Upfront license fee | $ 30,000,000 | ||||||||
Pint Pharma International SA | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Number of countries covered under sub-license agreement | Country | 21 | ||||||||
Non-deductible, non-creditable upfront payment | $ 10,000,000 | ||||||||
Pint Pharma International SA | Mexico | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Number of countries covered under sub-license agreement | Country | 1 | ||||||||
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 | CANbridge Life Sciences | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Company obligations for potential milestone payments for CRO Contracts | 30,000,000 | $ 30,000,000 | |||||||
Sales-based milestone payments | $ 185,000,000 | $ 185,000,000 | |||||||
Maximum | Pint Pharma International SA | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Potential development and commercial performance obligations milestones | $ 24,500,000 |
Summary of Product Revenues fro
Summary of Product Revenues from Customers (Detail) - Customer Concentration Risk - Total Revenues | 12 Months Ended |
Dec. 31, 2018 | |
CVS/Caremark | |
Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 39.00% |
Accredo/Acaria | |
Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 25.00% |
Diplomat | |
Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 13.00% |
Assets Measured at Fair Value o
Assets Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 86,316 | $ 67,753 |
Total | 143,318 | 67,753 |
Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 35,941 | |
Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 18,077 | |
U.S. government securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 2,984 | |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 83,329 | 67,753 |
Total | 86,313 | $ 67,753 |
Level 1 | U.S. government securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 2,984 | |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 2,987 | |
Total | 57,005 | |
Level 2 | Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 35,941 | |
Level 2 | Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 18,077 |
Summary of Short-term Investmen
Summary of Short-term Investments (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Schedule Of Available For Sale Securities [Line Items] | ||
Cash equivalents, Amortized cost | $ 108,419 | $ 81,698 |
Marketable securities, Amortized cost | 143,330 | 67,753 |
Marketable securities, Unrealized Losses | (12) | |
Marketable securities, Estimated fair value | 143,318 | 67,753 |
Cash equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cash equivalents, Amortized cost | 86,316 | 67,753 |
Cash equivalents, Estimated fair value | $ 86,316 | $ 67,753 |
Corporate bonds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, Maturity (in years) | Less than 1 | |
Marketable securities, Amortized cost | $ 18,089 | |
Marketable securities, Unrealized Losses | (12) | |
Marketable securities, Estimated fair value | $ 18,077 | |
U.S. government securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, Maturity (in years) | Less than 1 | |
Marketable securities, Amortized cost | $ 2,984 | |
Marketable securities, Estimated fair value | $ 2,984 | |
Commercial paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, Maturity (in years) | Less than 1 | |
Marketable securities, Amortized cost | $ 35,941 | |
Marketable securities, Estimated fair value | $ 35,941 |
Components of Prepaid Expenses
Components of Prepaid Expenses and Other (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | $ 12,397 | $ 12,997 |
Prepaid expenses and other, long-term | 3,429 | 1,989 |
Totals | 15,826 | 14,986 |
CRO services | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 5,824 | 7,188 |
Prepaid expenses and other, long-term | 1,073 | 860 |
Other clinical development | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 888 | 878 |
Prepaid expenses and other, long-term | 650 | 886 |
Insurance | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 2,446 | 1,306 |
Prepaid expenses and other, long-term | 14 | 26 |
Other | ||
Prepaid Expenses [Line Items] | ||
Prepaid expenses and other, current | 3,239 | 3,625 |
Prepaid expenses and other, long-term | $ 1,692 | $ 217 |
Schedule of Other Current Asset
Schedule of Other Current Assets (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Insurance receivable | $ 1,175 |
Other | 612 |
Totals | $ 1,787 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 9,139 | $ 8,533 |
Less: accumulated depreciation | (5,176) | (4,063) |
Totals | 3,963 | 4,470 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 4,048 | 3,878 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 2,402 | 2,147 |
Telephone Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 343 | 302 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 2,346 | $ 2,206 |
Schedule of Intangible Assets (
Schedule of Intangible Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Finite Lived Intangible Assets [Line Items] | ||
Acquired and in-licensed rights | $ 50,000 | |
Less: accumulated amortization | (5,592) | |
Total intangible asset, net | $ 44,408 | $ 48,355 |
Acquired and in-licensed rights | ||
Finite Lived Intangible Assets [Line Items] | ||
Estimated useful life | 13 years |
Schedule of Estimated Future In
Schedule of Estimated Future Intangible Amortization Expense (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Finite Lived Intangible Assets Future Amortization Expense [Abstract] | |
2,019 | $ 3,947 |
2,020 | 3,947 |
2,021 | 3,947 |
2,022 | 3,947 |
Thereafter | 28,620 |
Total | $ 44,408 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Accrued CRO services | $ 10,187 | $ 8,335 |
Accrued royalties | 9,162 | 3,922 |
Accrued class action verdict costs | 9,000 | |
Accrued variable consideration | 3,818 | 1,425 |
Accrued bonus | 1,705 | 3,376 |
Accrued compensation | 4,435 | 2,797 |
Accrued legal fees | 1,379 | 2,046 |
Accrued other clinical development | 2,380 | 3,438 |
Other | 4,365 | 5,309 |
Totals | $ 46,431 | $ 30,648 |
Debt - Schedule of Long Term De
Debt - Schedule of Long Term Debt (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Debt Disclosure [Abstract] | ||
Long term debt | $ 155,000 | |
Accretion of final interest payment | 1,330 | |
Less: deferred financing costs | (4,444) | |
Total long term debt, net | $ 151,886 | $ 48,477 |
Long term debt, maturity date | May 1, 2023 |
Debt - Additional Information (
Debt - Additional Information (Detail) - Silicon Valley Bank and Oxford finance - Term Loan - USD ($) | 1 Months Ended | 12 Months Ended | |
May 31, 2018 | Oct. 31, 2017 | Dec. 31, 2018 | |
Debt Instrument [Line Items] | |||
Line of credit facility, effective date | Oct. 31, 2017 | ||
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 | ||
Line of credit facility aggregate fees required to pay to lenders | 4,200,000 | ||
Line of credit facility fee | 400,000 | ||
Line of credit facility repayment of borrowings fee | $ 3,800,000 | ||
Percentage of issued and outstanding capital stock of its subsidiary pledged | 65.00% | ||
Interest rate, description | The term loans under the amended credit facility bear 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 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 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% | ||
Covenant, description | The amended credit facility includes affirmative and negative covenants applicable to the Company, its current subsidiary 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 product revenue, measured as of the last day of each fiscal quarter on a trailing 3-month basis, that is (i) greater than or equal to 70% of the Company’s revenue target set forth in its board-approved projections for the 2018 fiscal year and (ii) greater than or equal to 50% of the Company’s revenue target set forth in its board-approved projections for the 2019 fiscal year. New minimum revenue levels will be established for each subsequent fiscal year by mutual agreement of the Company, SVB as administrative agent, and the lenders. 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. | ||
Credit facility covenants, percentage of target revenue to be achieved for 2018 fiscal year | 70.00% | ||
Credit facility covenants, percentage of target revenue to be achieved for 2019 fiscal year | 50.00% | ||
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 | ||
Term loan, outstanding amount | $ 155,000,000 | ||
First Anniversary of Funding | |||
Debt Instrument [Line Items] | |||
Prepayment fee, percentage | 3.00% | ||
Between First Anniversary and Second Anniversary | |||
Debt Instrument [Line Items] | |||
Prepayment fee, percentage | 2.00% | ||
After Second Anniversary and Prior to May 1, 2023 | |||
Debt Instrument [Line Items] | |||
Prepayment fee, percentage | 1.00% | ||
Prime Rate | |||
Debt Instrument [Line Items] | |||
Basis spread on variable rate | 3.50% |
Stockholders Equity - Additiona
Stockholders Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Oct. 20, 2016 | Oct. 19, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Oct. 31, 2011 |
Stockholders Equity Note [Line Items] | |||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | |||||
Issuance of common stock, per share | $ 40 | ||||||
Underwriters option exercisable period | 30 days | ||||||
Net proceeds from issuance of common stock | $ 161,854 | ||||||
Issuance of common stock on exercise of option | 200,743 | 557,080 | 43,751 | ||||
Common stock issued upon vesting of RSUs | 529,443 | 211,761 | 2,917 | ||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | |||||
Shares of stock authorized before amendment | 100,000,000 | ||||||
Warrant expiration date | Oct. 4, 2021 | ||||||
Issuance of common stock on exercise of option | 5,708,544 | 6,134,513 | 6,578,522 | 5,542,285 | |||
Share based compensation awarded | 315,566 | 519,791 | 1,658,465 | ||||
Weighted-average grant date fair value of options granted | $ 45.62 | $ 24.30 | $ 25.69 | ||||
Non Vested Stock Options | |||||||
Stockholders Equity Note [Line Items] | |||||||
Estimated unrecognized employee compensation cost related to non-vested stock options granted | $ 20,800 | ||||||
Estimated unrecognized employee compensation cost related to non-vested stock options granted, Weighted-average period of recognition | 1 year 6 months | ||||||
Restricted Stock Units | |||||||
Stockholders Equity Note [Line Items] | |||||||
Common stock issued upon vesting of RSUs | 529,443 | 211,761 | |||||
Estimated unrecognized employee compensation cost related to non-vested stock options granted | $ 87,900 | ||||||
Estimated unrecognized employee compensation cost related to non-vested stock options granted, Weighted-average period of recognition | 2 years | ||||||
Weighted-average grant date fair value of RSUs | $ 41.42 | $ 94.93 | $ 54.35 | ||||
2011 Plan | |||||||
Stockholders Equity Note [Line Items] | |||||||
Common stock shares reserved for issuance | 12,529,412 | ||||||
Issuance of common stock on exercise of option | 7,175,879 | ||||||
Common stock shares available for future issuance | 2,339,678 | ||||||
2017 Employment Inducement Incentive Award Plan | |||||||
Stockholders Equity Note [Line Items] | |||||||
Common stock shares reserved for issuance | 1,000,000 | ||||||
Share based compensation awarded | 371,335 | ||||||
Common Stock | |||||||
Stockholders Equity Note [Line Items] | |||||||
Issuance of common stock, shares | 4,312,500 | ||||||
Issuance of common stock on exercise of option | 200,743 | 557,080 | 46,668 | ||||
Shares of common stock that could be acquired by warrant | 2,116,250 | ||||||
Common stock price | $ 16 | ||||||
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 | ||||||
Minimum | Common Stock | Alan Auerbach | |||||||
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% | ||||||
Underwritten Public Offering | |||||||
Stockholders Equity Note [Line Items] | |||||||
Issuance of common stock, shares | 3,750,000 | ||||||
Common stock, par value | $ 0.0001 | ||||||
Issuance of common stock, per share | $ 40 | ||||||
Net proceeds from issuance of common stock | $ 161,900 | ||||||
Overallotment Option Exercise by Underwriters | Maximum | |||||||
Stockholders Equity Note [Line Items] | |||||||
Issuance of common stock, shares | 562,500 |
Fair Value Options Weighted-Ave
Fair Value Options Weighted-Average Assumptions (Detail) - Employee Stock Option | 2 Months Ended | 12 Months Ended |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility | 96.50% | 70.20% |
Risk-free interest rate | 2.70% | 2.00% |
Expected life in years | 5 years 10 months 6 days | 5 years 9 months 29 days |
Employee Stock-based Compensati
Employee Stock-based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total share-based compensation expense | $ 86,939 | $ 108,735 | $ 117,264 |
Employee Stock Option | Research and development | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total share-based compensation expense | 26,456 | 67,299 | 88,049 |
Employee Stock Option | Selling, general and administrative | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total share-based compensation expense | 14,063 | 23,024 | 25,043 |
Performance Awards | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total share-based compensation expense | (528) | ||
Restricted Stock Units | Research and development | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total share-based compensation expense | 25,569 | 10,242 | 3,120 |
Restricted Stock Units | Selling, general and administrative | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total share-based compensation expense | $ 20,851 | $ 8,170 | $ 1,580 |
Activity with Respect to Option
Activity with Respect to Options Granted (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Shares | ||||
Beginning balance, shares | 6,134,513 | 6,578,522 | 5,542,285 | |
Granted, shares | 315,566 | 519,791 | 1,658,465 | |
Forfeited, shares | (183,837) | (285,377) | (446,544) | |
Exercised, shares | (200,743) | (557,080) | (43,751) | |
Expired, shares | (356,955) | (121,343) | (131,933) | |
Ending balance, shares | 5,708,544 | 6,134,513 | 6,578,522 | 5,542,285 |
Nonvested, shares | 779,292 | 1,788,436 | 3,106,083 | |
Exercisable, shares | 4,929,252 | |||
Weighted Average Exercise Price | ||||
Beginning Balance, Weighted Average Exercise Price | $ 87.91 | $ 87.52 | $ 105.59 | |
Granted, Weighted Average Exercise Price | 59.13 | 38.87 | 42.34 | |
Forfeited, Weighted Average Exercise Price | 51.96 | 50.11 | 122.50 | |
Exercised, Weighted Average Exercise Price | 35.88 | 48.71 | 13.16 | |
Expired, Weighted Average Exercise Price | 116.96 | 125.40 | 185.10 | |
Ending Balance, Weighted Average Exercise Price | 87.49 | $ 87.91 | $ 87.52 | $ 105.59 |
Nonvested, Weighted Average Exercise Price | 48.97 | |||
Exercisable, Weighted Average Exercise Price | $ 93.58 | |||
Weighted Average Remaining Contractual Term (years) | ||||
Weighted Average Remaining Contractual Term (years) | 6 years 1 month 6 days | 7 years 2 months 12 days | 8 years | 8 years 7 months 6 days |
Granted, Weighted Average Remaining Contractual Term (years) | 9 years 3 months 18 days | 8 years 4 months 24 days | 9 years 3 months 18 days | |
Nonvested, Weighted Average Remaining Contractual Term (years) | 8 years 6 months | |||
Exercisable, Weighted Average Remaining Contractual Term (years) | 5 years 8 months 12 days | |||
Aggregate Intrinsic Value | ||||
Shares, Outstanding, Aggregate Intrinsic Value | $ 7,762 | $ 220,060 | $ 18,442 | $ 87,632 |
Exercised, Aggregate Intrinsic Value | 5,063 | $ 27,185 | $ 1,360 | |
Exercisable, Aggregate Intrinsic Value | $ 7,762 |
Stock Options (Detail)
Stock Options (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Shares | |||
Nonvested shares, Beginning balance | 1,788,436 | 3,106,083 | |
Granted, shares | 315,566 | 519,791 | 1,658,465 |
Vested/Issued, shares | (1,140,873) | (1,552,061) | |
Forfeited, shares | (183,837) | (285,377) | |
Nonvested shares, Ending balance | 779,292 | 1,788,436 | 3,106,083 |
Weighted Average Grant-Date Fair Value | |||
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value | $ 33.37 | $ 47.78 | |
Granted, Weighted Average Grant-Date Fair Value | 45.62 | 24.30 | $ 25.69 |
Vested/Issued, Weighted Average Grant-Date Fair Value | 36.81 | 59.76 | |
Forfeited, Weighted Average Grant-Date Fair Value | 31.43 | 30.21 | |
Nonvested, Ending balance, Weighted Average Grant-Date Fair Value | $ 33.75 | $ 33.37 | $ 47.78 |
Restricted Stock Units (Detail)
Restricted Stock Units (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Shares | |||
Vested/Issued, shares | (529,443) | (211,761) | (2,917) |
Restricted Stock Units | |||
Shares | |||
Nonvested shares, Beginning balance | 1,637,662 | 630,508 | |
Granted, shares | 1,175,231 | 1,277,081 | |
Vested/Issued, shares | (529,443) | (211,761) | |
Forfeited, shares | (444,780) | (58,166) | |
Nonvested shares, Ending balance | 1,838,670 | 1,637,662 | 630,508 |
Weighted Average Grant-Date Fair Value | |||
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value | $ 85.58 | $ 54.35 | |
Granted, Weighted Average Grant-Date Fair Value | 41.42 | 94.93 | $ 54.35 |
Vested/Issued, Weighted Average Grant-Date Fair Value | 79.98 | 55.17 | |
Forfeited, Weighted Average Grant-Date Fair Value | 80.99 | 63.02 | |
Nonvested, Ending balance, Weighted Average Grant-Date Fair Value | $ 60.08 | $ 85.58 | $ 54.35 |
401(K) Savings Plan - Additiona
401(K) Savings Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Benefit Plan Disclosure [Line Items] | |||
Employer matching contribution expenses | $ 1.9 | $ 0.9 | $ 1 |
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% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Contingency [Line Items] | |||
Federal corporate income tax rate | 21.00% | 35.00% | |
Limitation on executive compensation deduction | $ 4,600,000 | ||
Limitation on interest expense | 9,200,000 | ||
Provisional tax impact related to the revaluation of deferred tax assets | 141,100,000 | ||
Provision for income taxes | 17,000 | $ 0 | $ 0 |
Prior period adjustment | 15,750,000 | ||
Increase in valuation allowance | $ 5,500,000 | 48,100,000 | |
Federal operating loss carryforwards, expiration beginning year | 2,028 | ||
State operating loss carryforwards, expiration beginning year | 2,031 | ||
Unrecognized tax benefits that would affect the effective tax rate, if recognized | $ 8,800,000 | ||
Federal | |||
Income Tax Contingency [Line Items] | |||
Operating loss carryforwards | $ 948,500,000 | ||
Federal | Research and development credit carryforwards | |||
Income Tax Contingency [Line Items] | |||
Tax credit carryforwards | $ 23,200,000 | ||
Tax credit carryforwards, expiration beginning year | 2,032 | ||
State | |||
Income Tax Contingency [Line Items] | |||
Operating loss carryforwards | $ 863,900,000 | ||
State | Research and development credit carryforwards | |||
Income Tax Contingency [Line Items] | |||
Tax credit carryforwards | $ 11,900,000 |
Schedule of Provision for Incom
Schedule of Provision for Income Taxes (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Current: | |||
State | $ 17,000 | ||
Total current | 17,000 | ||
Deferred: | |||
Total | $ 17,000 | $ 0 | $ 0 |
Schedule of Income Tax Reconcil
Schedule of Income Tax Reconciliation (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Tax computed at the federal statutory rate | $ (23,771,000) | $ (99,234,000) | $ (93,839,000) |
State taxes | (2,791,000) | (15,890,000) | (15,693,000) |
Permanent items | 10,932,000 | (1,404,000) | 6,152,000 |
R&D credits | (5,630,000) | (6,217,000) | (2,728,000) |
Deferred tax asset adjustment | 6,805,000 | ||
Other | (20,000) | (113,000) | |
Impact of federal statutory rate change related to the 2017 Tax Act | 141,147,000 | ||
Prior year adjustments | 15,750,000 | ||
Change in valuation allowance | 5,527,000 | (25,187,000) | 106,221,000 |
Total | $ 17,000 | $ 0 | $ 0 |
Components of Net Deferred Tax
Components of Net Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets | ||
Net operating loss carry forwards | $ 257,021 | $ 257,121 |
Business credit carry forwards | 35,107 | 29,695 |
Organization costs | 3,593 | 180 |
Compensation | 72,804 | 76,423 |
Deferred rent - leasehold improvement | 1,404 | 680 |
Other | 806 | |
Subtotal | 369,929 | 364,905 |
Deferred tax liabilities | (255) | (758) |
Total deferred tax assets | 369,674 | 364,147 |
Valuation allowance | (369,674) | (364,147) |
Net deferred tax assets | $ 0 | $ 0 |
Reconciliation of Unrecognized
Reconciliation of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Unrecognized tax benefits | $ 7,151 | $ 5,315 | $ 4,475 |
Gross increases - tax positions in a current period | 1,626 | 1,836 | 840 |
Unecognized tax benefits - December 31 | $ 8,777 | $ 7,151 | $ 5,315 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ / shares in Units, shares in Millions | Jan. 29, 2019USD ($)$ / sharesshares | Jun. 30, 2012USD ($)ft² | Dec. 31, 2011USD ($)ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jul. 10, 2018Officer | Apr. 14, 2016DerivativeLawsuit |
Commitments And Contingencies Disclosure [Line Items] | ||||||||
Rent expense | $ 4,700,000 | $ 3,900,000 | $ 3,500,000 | |||||
License agreement, expected milestone payment | 187,500,000 | |||||||
Company obligations for potential milestone payments for CRO Contracts | $ 27,200,000 | |||||||
Number of stockholders derivative lawsuits | DerivativeLawsuit | 2 | |||||||
Hsingching Hsu | Subsequent Event | ||||||||
Commitments And Contingencies Disclosure [Line Items] | ||||||||
Damages awarded per share | $ / shares | $ 4.50 | |||||||
Loss contingency damages awarded percent of total claim | 5.00% | |||||||
Loss contingency claimed damages awarded per share | $ / shares | $ 87.20 | |||||||
Number of shares traded to claim damages | shares | 10 | |||||||
Executive Officer | Hsingching Hsu | ||||||||
Commitments And Contingencies Disclosure [Line Items] | ||||||||
Number of officers filed motion for favorable judgment | Officer | 2 | |||||||
Minimum | Hsingching Hsu | Subsequent Event | ||||||||
Commitments And Contingencies Disclosure [Line Items] | ||||||||
Percentage of stockholders sufficient to recover damages | 20.00% | |||||||
Amount of damages after claimsAmount of damages after claims | $ 9,000,000 | |||||||
Maximum | Hsingching Hsu | Subsequent Event | ||||||||
Commitments And Contingencies Disclosure [Line Items] | ||||||||
Percentage of stockholders sufficient to recover damages | 40.00% | |||||||
Amount of damages after claimsAmount of damages after claims | $ 18,000,000 | |||||||
CRO services | Minimum | ||||||||
Commitments And Contingencies Disclosure [Line Items] | ||||||||
Written notice of termination, period | 30 days | |||||||
CRO services | Maximum | ||||||||
Commitments And Contingencies Disclosure [Line Items] | ||||||||
Written notice of termination, period | 45 days | |||||||
Lease Agreement executed on December 2011 | ||||||||
Commitments And Contingencies Disclosure [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 | $ 2,500,000 | |||||||
Lease Agreement executed on June 2012 | ||||||||
Commitments And Contingencies Disclosure [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 | $ 1,591,400 |
Future Minimum Lease Payments (
Future Minimum Lease Payments (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2,019 | $ 4,924 |
2,020 | 5,141 |
2,021 | 5,300 |
2,022 | 5,464 |
Thereafter | 18,927 |
Total | $ 39,756 |
Summary of Clinical Research Or
Summary of Clinical Research Organization Contracts (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |
Estimated Contractual Obligation | $ 95,741 |
HER2 Overexpressed/Amplified Breast Cancer (Extension) | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |
Estimated Contractual Obligation | $ 11,690 |
Months Remaining on Contract | 15 months |
HER2 Overexpressed/Amplified Breast Cancer (Licensor Legacy Clinical Trials) | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |
Estimated Contractual Obligation | $ 1,191 |
Months Remaining on Contract | 8 months |
HER2 Mutated Breast Cancer and HER2 Mutated Breast Cancer with Brain Mets | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |
Estimated Contractual Obligation | $ 109 |
Months Remaining on Contract | 36 months |
Metastatic & Adjuvant Breast Cancer | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |
Estimated Contractual Obligation | $ 25,618 |
Months Remaining on Contract | 10 months |
Neoadjuvant Breast Cancer | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |
Estimated Contractual Obligation | $ 779 |
Months Remaining on Contract | 6 months |
Preclinical Research | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |
Estimated Contractual Obligation | $ 6,838 |
Months Remaining on Contract | 13 months |
HER2 Mutated Solid Tumors | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |
Estimated Contractual Obligation | $ 14,602 |
Months Remaining on Contract | 14 months |
Other | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |
Estimated Contractual Obligation | $ 34,914 |
Months Remaining on Contract | 20 months |
Quarterly Financial Data (Detai
Quarterly Financial Data (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||
Revenues | $ 71,079 | $ 62,629 | $ 50,767 | $ 66,516 | $ 21,608 | $ 6,077 | $ 250,991 | $ 27,685 | |||||||
Net loss | (30,694) | (14,201) | (44,335) | (24,345) | 64,078 | 77,180 | $ 77,832 | $ 72,865 | $ (72,661) | $ (65,781) | $ (66,597) | $ (70,972) | (113,575) | (291,955) | $ (276,011) |
Net loss attributable to common stock | $ (30,694) | $ (14,201) | $ (44,335) | $ (24,345) | $ 64,078 | $ 77,180 | $ 77,832 | $ 72,865 | $ (72,661) | $ (65,781) | $ (66,597) | $ (70,972) | $ (113,575) | $ (291,955) | $ (276,011) |
Net loss per share—basic and diluted | $ (0.80) | $ (0.37) | $ (1.17) | $ (0.65) | $ 1.71 | $ 2.07 | $ 2.10 | $ 1.97 | $ (2.04) | $ (2.02) | $ (2.05) | $ (2.19) | $ (2.99) | $ (7.85) | $ (8.29) |
Weighted-average shares of common stock outstanding—basic and diluted | 38,201,056 | 38,043,174 | 37,819,767 | 37,699,024 | 37,534,410 | 37,214,002 | 36,992,017 | 36,931,167 | 35,694,193 | 32,497,168 | 32,493,092 | 32,478,408 | 37,942,411 | 37,169,678 | 33,295,114 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) | Jan. 09, 2019USD ($) |
Knight Agreement | Maximum | Subsequent Event | |
Subsequent Event [Line Items] | |
Upfront and milestone payments | $ 7,200,000 |