Puma Biotechnology (PBYI) 10-Q 5 Nov 18 2018 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2018	Oct. 26, 2018
Document And Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2018
Document Fiscal Year Focus	2,018
Document Fiscal Period Focus	Q3
Trading Symbol	PBYI
Entity Registrant Name	PUMA BIOTECHNOLOGY, INC.
Entity Central Index Key	1,401,667
Current Fiscal Year End Date	--12-31
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Common Stock, Shares Outstanding		38,134,994

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Current assets:
Cash and cash equivalents	$ 68,299	$ 81,698
Marketable securities	59,652
Accounts receivable, net	19,750	9,670
Inventory	2,832	2,029
Prepaid expenses, and other, current	12,383	12,997
Other current assets	11,495
Total current assets	174,411	106,394
Property and equipment, net	4,240	4,470
Prepaid expenses and other, long-term	2,359	1,989
Intangible assets, net	45,395	48,355
Restricted cash	4,318	4,317
Total assets	230,723	165,525
Current liabilities:
Accounts payable	16,363	27,692
Accrued expenses	41,517	30,648
Total current liabilities	57,880	58,340
Deferred rent	5,876	5,406
Long-term debt	121,054	48,477
Total liabilities	184,810	112,223
Commitments and contingencies (Note 11)
Stockholders' equity:
Common stock - $.0001 par value per share; 100,000,000 shares authorized; 38,125,122 shares issued and outstanding at September 30, 2018 and 37,594,851 issued and outstanding at December 31, 2017	4	4
Additional paid-in capital	1,217,258	1,142,213
Receivable from exercise of stock options		(449)
Accumulated other comprehensive loss	(3)
Accumulated deficit	(1,171,346)	(1,088,466)
Total stockholders' equity	45,913	53,302
Total liabilities and stockholders' equity	$ 230,723	$ 165,525

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 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	38,125,122	37,594,851
Common stock, shares outstanding	38,125,122	37,594,851

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Revenue:
Total revenue	$ 62,629	$ 6,077	$ 179,912	$ 6,077
Operating costs and expenses:
Cost of sales	9,048	1,526	24,262	1,526
Selling, general and administrative	28,502	32,489	105,239	75,819
Research and development	36,360	49,502	126,529	157,556
Total operating costs and expenses	73,910	83,517	256,030	234,901
Loss from operations	(11,281)	(77,440)	(76,118)	(228,824)
Other (expenses) income:
Interest income	590	305	1,093	1,035
Interest expense	(3,499)		(7,165)
Other expenses	(11)	(45)	(690)	(88)
Total other (expenses) income:	(2,920)	260	(6,762)	947
Net loss	(14,201)	(77,180)	(82,880)	(227,877)
Net loss applicable to common stockholders	$ (14,201)	$ (77,180)	$ (82,880)	$ (227,877)
Net loss per common share—basic and diluted	$ (0.37)	$ (2.07)	$ (2.19)	$ (6.15)
Weighted-average common shares outstanding—basic and diluted	38,043,174	37,214,002	37,855,249	37,046,765
Product Revenue, Net
Revenue:
Total revenue	$ 52,629	$ 6,077	$ 139,412	$ 6,077
License Revenue
Revenue:
Total revenue	$ 10,000		$ 40,500

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Statement Of Income And Comprehensive Income [Abstract]
Net loss	$ (14,201)	$ (77,180)	$ (82,880)	$ (227,877)
Other comprehensive loss
Unrealized gain (loss) on available-for-sale securities	(2)	18	(3)	6
Comprehensive loss	$ (14,203)	$ (77,162)	$ (82,883)	$ (227,871)

Condensed Consolidated Statem_3

Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - 9 months ended Sep. 30, 2018 - 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, 2017	$ 53,302	$ 4	$ 1,142,213	$ (449)		$ (1,088,466)
Beginning Balance (in shares) at Dec. 31, 2017	37,594,851	37,594,851
Stock-based compensation	$ 68,343		68,343
Shares issued or restricted stock units vested under employee stock plans	7,151		6,702	$ 449
Shares issued or RSUs vested under employee stock plans (in shares)		530,271
Unrealized loss on available-for-sale securities	(3)				$ (3)
Net loss	(82,880)					(82,880)
Ending Balance at Sep. 30, 2018	$ 45,913	$ 4	$ 1,217,258		$ (3)	$ (1,171,346)
Ending Balance (in shares) at Sep. 30, 2018	38,125,122	38,125,122

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Operating activities:
Net loss	$ (82,880)	$ (227,877)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	5,279	1,451
Stock-based compensation	68,343	83,213
Debt modification fees	289
Changes in operating assets and liabilities:
Accounts receivable, net	(10,080)	(3,890)
Inventory	(803)	(89)
Prepaid expenses and other	244	712
Other current assets	(11,495)
Accounts payable	(11,388)	(2,496)
Accrued expenses	10,869	12,182
Accrual of deferred rent	470	(67)
Net cash used in operating activities	(31,152)	(136,861)
Investing activities:
Purchase of property and equipment	(550)	(286)
Purchase of available-for-sale securities	(71,112)	(79,728)
Sale/maturity of available-for-sale securities	11,457	88,096
Net cash (used in) provided by investing activities	(60,205)	8,082
Financing activities:
Net proceeds from exercise of stock options	7,151	14,002
Proceeds from long-term debt	75,000
Payment of debt issuance costs	(4,192)
Net cash provided by financing activities	77,959	14,002
Net increase (decrease) in cash, cash equivalents and restricted cash	(13,398)	(114,777)
Cash, cash equivalents and restricted cash, beginning of period	86,015	198,811
Cash, cash equivalents and restricted cash, end of period	72,617	84,034
Supplemental disclosures of non-cash investing and financing activities:
Licensor fee due in accrued expenses		50,000
Property and equipment purchases in accounts payable	59	105
Receivables related to stock option exercises		$ 5,653
Supplemental disclosure of cash flow information:
Interest paid	$ 5,134

Business and Basis of Presentat

Business and Basis of Presentation	9 Months Ended
	Sep. 30, 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. 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 $14.2 million and $82.9 million for the three and nine months ended September 30, 2018, and negative cash flows from operations of approximately $31.2 million for the nine months ended September 30, 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, which raises substantial doubt about its ability to continue as a going concern. 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 entered into exclusive license agreements with Specialised Therapeutics Asia Pte Ltd., or STA, Medison Pharma Ltd., or Medison, and CANbridgepharma Limited, or CANbridge, and, most recently, Pint Pharma International SA, or Pint, to pursue regulatory approval and commercialize NERLYNX, if approved, in South East Asia, Israel, greater China and Mexico and various countries and territories in Central and South America, respectively. The Company plans to continue to pursue commercialization of NERLYNX in other 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. The Company is required to make substantial payments to Pfizer Inc., or Pfizer, upon the achievement of certain milestones and has contractual obligations for clinical trial contracts. Commercialization in the United States and in the European Union, may require funding in addition to the cash and cash equivalents totaling approximately $68.3 million and marketable securities totaling approximately $59.7 million available at September 30, 2018. While the consolidated financial statements have been prepared on a going concern basis, 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. The Company’s continued operations will depend on its ability to successfully commercialize NERLYNX, the Company’s only product approved by the FDA and by the EC, and to obtain additional capital through various potential sources, such as equity and debt financing. Since its inception through September 30, 2018, the Company’s financing has primarily been through product revenue, public offerings of Company common stock, private equity placements, 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	9 Months Ended
	Sep. 30, 2018
Accounting Policies [Abstract]
Significant Accounting Policies	Note 2—Significant Accounting Policies: The significant accounting policies followed in the preparation of these unaudited condensed 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 Generally Accepted Accounting Principles, or GAAP, requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of 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 unaudited condensed 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 Company’s license 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 of 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. The FDA approval of NERLYNX in July 2017 triggered a one-time milestone payment pursuant to the Company’s license agreement with the 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 through 2030, the estimated useful life of the licensed patent. The Company recorded amortization expense related to its intangible asset of $1.0 million and $3.0 million for the three and nine months ended September 30, 2018, respectively. As of September 30, 2018, estimated future amortization expense related to the Company’s intangible asset was approximately $0.9 million for the remainder of 2018, approximately $3.9 million for each year starting 2019 through 2029, and approximately $1.0 million for 2030. Royalties: Royalties incurred in connection with the Company’s license agreement with Pfizer 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 acquired prior to receipt of marketing approval of a product candidate is recorded as research and development expense as incurred. Inventory that can be used in the production of either 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 September 30, 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 ASC 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 606, when its customer obtains control of the promised goods or services, an entity recognizes revenue 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 after the FDA approved NERLYNX in July 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 606, the entity performs the following five steps: (i) identifies the contract(s) with a customer, (ii) identifies the performance obligations in the contract, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations in the contract, and (v) recognizes revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net (below). Product Revenue, Net: The Company sells NERLYNX to a limited number of specialty pharmacies and specialty distributors in the United States. These customers subsequently resell the Company’s products to patients and certain medical centers or hospitals. In addition to distribution agreements with these customers, the Company enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the specialty pharmacy or specialty distributor, as applicable, obtains control of the Company's product, which occurs at a point in time (upon delivery). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 10 and 68 days. Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods, and are recorded in cost of sales. If taxes should be collected from these customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the three months ended September 30, 2018. Product revenue from customers who individually accounted for 10% or more of the Company’s total revenue for the three months ended September 30, 2018 consisted of the following, shown as a percentage of total revenue: Three Months Ended September 30, 2018 Customer A 35 % Customer B 27 % Customer C 14 % License Revenue: The Company also recognizes license revenue under certain of the Company’s license agreements that are within the scope of ASC 606. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. The Company evaluates these agreements under ASC 606 to determine the distinct performance obligations. Non-refundable, up-front 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. Variable consideration may include nonrefundable upfront license fees, payments for research and development activities, reimbursement of certain third-party costs, payments based upon the achievement of specified milestones, and royalty payments based on product sales derived from the collaboration. 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. The period between when the Company transfers control of the promised goods to a customer and when the Company receives payment from such customer is expected to be one year or less During the first quarter of 2018, the Company entered into sub-licensing agreements with CANbridge and Medison, to pursue regulatory approval and commercialize NERLYNX, if approved, in the People’s Republic of China (including mainland China, Hong Kong, Macao, and Taiwan) and Israel, respectively. The license agreements granted intellectual property rights and set forth the parties’ respective obligations with respect to development, commercialization and supply of the licensed product. For both license agreements, non-refundable, upfront license fees were received and recognized as license revenue in accordance with ASC 606. Each respective 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 both CANBridge and Medison with the licensed product in accordance with the respective supply agreements. These supply arrangements have been identified as separate performance obligations. The Company also identified the Joint Steering Committee as a separate, distinct performance obligation. To determine the respective stand-alone selling prices, the Company estimated the transaction prices, including any variable consideration, at contract inception and determined the fair value of such obligations based on similar arrangements. When determining the transaction prices, the Company assumed that the goods or services will be transferred to the customer based on the terms of the existing contract, and did not take into consideration the possibility of a contract being canceled, renewed, or modified. The Company noted there was no additional variable consideration, significant financing components, noncash consideration, or consideration payable to the customer in these agreements. 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 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 September 30, 2018 and, therefore, the transaction price was not reduced further during the quarter ended September 30, 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. However, 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 September 30, 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 available industry data and 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. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. 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 September 30, 2018 and December 31, 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): September 30, 2018 Level 1 Level 2 Level 3 Total Cash equivalents $ 50,176 $ 3,016 $ — $ 53,192 Commercial paper — 44,642 — 44,642 Corporate bonds — 12,043 — 12,043 US government 2,967 — — 2,967 $ 53,143 $ 59,701 $ — $ 112,844 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 September 30, 2018 (in years) cost Gains Losses fair value Cash equivalents $ 53,193 $ — $ (1 ) $ 53,192 Commercial paper Less than 1 44,642 — — 44,642 Corporate bonds Less than 1 12,045 — (2 ) 12,043 US government Less than 1 2,967 — — 2,967 $ 112,847 $ - $ (3 ) $ 112,844 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 September 30, 2018, were approximately $73.5 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 R&D expenses include clinical manufacturing costs, clinical trial expenses, consulting and other third-party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs. Clinical trial expenses include, but are not limited to, investigator fees, site costs, comparator drug costs, and clinical research organization, or CRO, costs. In the normal course of business, the Company contracts with third parties to perform various clinical trial activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variations from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients and the completion of portions of the clinical trial or similar conditions. The Company’s accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs. The objective of the Company’s accrual policy is to match the recording of expenses in the unaudited condensed consolidated financial statements to the actual services received and efforts expended. As actual costs become known, the Company adjusts its accruals in that period. In instances where the Company enters i

Prepaid Expenses and Other

Prepaid Expenses and Other	9 Months Ended
	Sep. 30, 2018
Banking And Thrift [Abstract]
Prepaid Expenses and Other	Note 3—Prepaid Expenses and Other: Prepaid expenses and other consisted of the following (in thousands): September 30, 2018 December 31, 2017 Current: CRO services $ 6,113 $ 7,188 Other clinical development 1,176 878 Insurance 277 1,306 Other 4,817 3,625 12,383 12,997 Long-term: CRO services 1,480 860 Other clinical development 740 886 Insurance 26 26 Other 113 217 2,359 1,989 Totals $ 14,742 $ 14,986 Other prepaid amounts consist primarily of deposits, licenses, subscriptions, software, and professional fees.

Other Current Assets

Other Current Assets	9 Months Ended
	Sep. 30, 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 (in thousands): September 30, 2018 December 31, 2017 Insurance receivable $ 11,232 $ — Other 263 $ — Totals $ 11,495 $ — Other current asset amounts consist primarily of insurance reimbursements related to the ongoing class action lawsuit.

Property and Equipment

Property and Equipment	9 Months Ended
	Sep. 30, 2018
Property Plant And Equipment [Abstract]
Property and Equipment	Note 5—Property and Equipment: Property and equipment consisted of the following (in thousands ): September 30, 2018 December 31, 2017 Property and Equipment: Leasehold improvements $ 4,047 $ 3,878 Computer equipment 2,402 2,147 Telephone equipment 343 302 Furniture and fixtures 2,346 2,206 9,138 8,533 Less: accumulated depreciation (4,898 ) (4,063 ) Totals $ 4,240 $ 4,470

Intangible assets, net

Intangible assets, net	9 Months Ended
	Sep. 30, 2018
Goodwill And Intangible Assets Disclosure [Abstract]
Intangible assets, net	Note 6—Intangible assets, net: Intangible assets, net consisted of the following (dollars in thousands): September 30, 2018 Estimated useful life Acquired and in-licensed rights $ 50,000 13 Years Less: accumulated amortization (4,605 ) Total intangible asset, net $ 45,395

Accrued Expenses

Accrued Expenses	9 Months Ended
	Sep. 30, 2018
Payables And Accruals [Abstract]
Accrued Expenses	Note 7—Accrued Expenses: Accrued expenses consisted of the following (in thousands): September 30, 2018 December 31, 2017 Accrued CRO services 9,656 $ 8,335 Accrued royalties 7,893 3,922 Accrued variable consideration 5,953 1,425 Accrued bonus 5,759 3,376 Accrued compensation 4,437 2,797 Accrued legal fees 3,205 2,046 Accrued other clinical development 1,876 3,438 Other 2,738 5,309 Totals $ 41,517 $ 30,648 Accrued CRO services and accrued other clinical development expenses 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 the Licensor. Accrued variable consideration represents estimates of adjustments to net revenue for which reserves are established.

Debt

Debt	9 Months Ended
	Sep. 30, 2018
Debt Disclosure [Abstract]
Debt	Note 8—Debt: Long term debt consisted of the following at September 30, 2018 (dollars in thousands): September 30, 2018 Maturity Date Long term debt $ 125,000 May 1, 2023 Accretion of final interest payment 784 Less: deferred financing costs (4,730 ) Total long term debt, net $ 121,054 On October 31, 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. On May 8, 2018, or the Amendment Date, the Company entered into the first 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 available on the Amendment Date, 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 available to be drawn at the Company’s option between September 30, 2018 and December 31, 2018, provided the Company has achieved a specified minimum revenue milestone and no event of default is occurring. 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. On the Amendment Date, the Company issued to SVB and Oxford, as the sole lenders on the Amendment Date, secured promissory notes in an aggregate principal amount of $125.0 million evidencing the amended credit facility.

Stockholders' Equity

Stockholders' Equity	9 Months Ended
	Sep. 30, 2018
Equity [Abstract]
Stockholders' Equity	Note 9—Stockholders’ Equity: Stock Options and Restricted Stock Units: The Company’s 2011 Incentive Award Plan, as amended, or the 2011 Plan, was adopted by the Company’s board of directors on September 15, 2011. Pursuant to the 2011 Plan, the Company may grant incentive stock options and nonqualified stock options, as well as other forms of equity-based compensation. Incentive stock options may be granted only to employees, while consultants, employees, officers and directors are eligible for the grant of nonqualified options under the 2011 Plan. The maximum term of stock options granted under the 2011 Plan is 10 years. 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 September 30, 2018, a total of 12,529,412 shares of the Company’s common stock had been reserved for issuance under the 2011 Plan. As of September 30, 2018, 7,063,571 shares of the Company’s common stock are issuable upon the vesting of RSU awards or exercise of outstanding awards granted under the 2011 Plan. As of September 30, 2018, 2,662,245 shares of the Company’s common stock are available for future issuance under the 2011 Plan. The Company’s 2017 Employment Inducement Incentive Award Plan, or the 2017 Plan, was adopted by the Company’s board of directors on April 27, 2017. Pursuant to the 2017 Plan, the Company may grant stock options and RSUs to newly hired employees, 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 September 30, 2018, a total of 1,000,000 shares of the Company’s common stock had been reserved for issuance under the 2017 Plan. As of September 30, 2018, 242,008 shares of the Company’s common stock are issuable upon the vesting of RSU awards granted under the 2017 Plan. As of September 30, 2018, 694,295 shares of the Company’s common stock are available for future issuance under the 2017 Plan. Stock-based compensation was as follows for the three and nine months ended September 30 (in thousands except per share data): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2018 2017 2018 2017 Stock-based compensation: Options - Research and development $ 5,387 $ 15,825 $ 22,689 $ 54,062 Selling, general and administrative 3,132 5,817 11,721 18,371 Restricted stock units - Selling, general and administrative 6,280 2,513 15,228 4,595 Research and development 6,008 2,333 18,705 6,185 Total stock-based compensation expense $ 20,807 $ 26,488 $ 68,343 $ 83,213 The fair value of options granted to employees was estimated using the Black-Scholes Option Pricing Method (see Note 2 –Significant Accounting Policies) with the following weighted-average assumptions used during the nine months ended September 30, 2018 and 2017. 2018 2017 Dividend yield 0.0 % 0.0 % Expected volatility 95.5 % 70.2 % Risk-free interest rate 2.5 % 2.0 % Expected life in years 5.85 5.83 Activity with respect to options granted under the 2011 Plan and 2017 Plan is summarized as follows: Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2017 6,134,513 $ 87.91 7.2 $ 220,060 Granted 225,566 $ 73.40 9.3 Forfeited (162,673 ) $ 53.78 Exercised (187,754 ) $ 35.70 $ 5,011 Expired (246,043 ) $ 122.38 Outstanding at September 30, 2018 5,763,609 $ 88.54 6.4 $ 38,856 Nonvested at September 30, 2018 893,980 $ 51.79 8.4 $ 4,361 At September 30, 2018, total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $25.5 million, which is expected to be recognized over a weighted-average period of 1.5 years. At September 30, 2018, the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $95.4 million, which is expected to be recognized over a weighted-average period of 2.1 years. The weighted-average grant date fair value of options granted during the nine months ended September 30, 2018 and 2017 was $56.46 and $24.30 per share, respectively. The weighted average grant date fair value of RSUs awarded during the nine months ended September 30, 2018 was $62.11 and $79.82 per share, respectively. Stock Option Rollforward Weighted Average Grant-Date Stock options Shares Fair Value Nonvested shares at December 31, 2017 1,788,436 $ 33.37 Granted 225,566 $ 56.46 Vested/Issued (957,349 ) $ 37.90 Forfeited (162,673 ) $ 32.46 Nonvested shares at September 30, 2018 893,980 $ 34.49 Restricted Stock Unit Rollforward Weighted Average Grant-Date Restricted stock units Shares Fair Value Nonvested shares at December 31, 2017 1,637,662 $ 85.58 Granted 538,320 $ 62.11 Vested/Issued (332,173 ) $ 65.32 Forfeited (301,839 ) $ 84.88 Nonvested shares at September 30, 2018 1,541,970 $ 81.89

401(k) Savings Plan

401(k) Savings Plan	9 Months Ended
	Sep. 30, 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 $1.3 million and $0.6 million

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 2018
Commitments And Contingencies Disclosure [Abstract]
Commitments and Contingencies	Note 11—Commitments and Contingencies: Contractual Obligations: Contractual obligations represent future cash commitments and liabilities under agreements with third parties, and exclude contingent liabilities for which the Company cannot reasonably predict future payment. The Company’s contractual obligations result primarily from obligations for various contract manufacturing organizations and clinical research organizations, which include potential payments we may be required to make under our agreements. The contracts also contain variable costs and milestones that are hard to predict as they are based on such things as patients enrolled and clinical trial sites. The timing of payments and actual amounts paid under contract manufacturing organization, or CMO, and CRO agreements may be different depending on the timing of receipt of goods or services or changes to agreed-upon terms or amounts for some obligations. Also, those agreements are cancelable upon written notice by the Company and, therefore, not long-term liabilities. Legal Proceedings The Company and certain of its 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. The Company does not believe these proceedings will have a material adverse effect on the Company’s results of operations, cash flows or financial condition. For certain legal expenses related to the ongoing class action matter described below, the Company receives reimbursements from its insurers. Currently, the Company expects to receive $11.2 million in reimbursements, all of which have been deemed probable and estimable as of September 30, 2018. Hsu vs. Puma Biotechnology, Inc., et. al. 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 the Company’s 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 its executive officers made false or misleading statements and 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. The court anticipates holding a trial in the first quarter of 2019. The Company intends to vigorously defend against Dr. Eshelman’s claims. Derivative Actions On April 12 and April 14, 2016, purported stockholders of the Company 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 Xing Xie v. Alan H. Auerbach, No. BC616617, and Kevin McKenney v. Auerbach, No. BC617059. The complaints asserted claims for breach of fiduciary duty, unjust enrichment, abuse of control, mismanagement and waste of corporate assets arising from substantially similar allegations as those contained in the securities class action described above. Separately, on February 9, 2018, another purported 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 Arnaud Van Der Gracht De Rommerswael vs. Alan H. Auerbach, et al., No. 8:18-cv-00236. The complaint asserted claims for violation of securities law, breach of fiduciary duty, waste of corporate assets, and unjust enrichment arising from substantially similar allegations as those contained in the securities class action described above. On May 30, 2018, another purported 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, captions Paul Duran vs. Alan H. Auerbach, et al., No. 2:18-cv-04802. The complaint asserted claims for violations of securities law, breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets. On July 30, 2018, the parties reached a settlement in principle of the Xie, Rommerswael and Duran lawsuits, and the parties are awaiting court approval of the settlement. The Company expects any amounts due as part of the settlement will be covered by the Company’s insurance policies.

Significant Accounting Polici_2

Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 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 Generally Accepted Accounting Principles, or GAAP, requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of 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 unaudited condensed 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 Company’s license 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 of 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. The FDA approval of NERLYNX in July 2017 triggered a one-time milestone payment pursuant to the Company’s license agreement with the 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 through 2030, the estimated useful life of the licensed patent. The Company recorded amortization expense related to its intangible asset of $1.0 million and $3.0 million for the three and nine months ended September 30, 2018, respectively. As of September 30, 2018, estimated future amortization expense related to the Company’s intangible asset was approximately $0.9 million for the remainder of 2018, approximately $3.9 million for each year starting 2019 through 2029, and approximately $1.0 million for 2030.
Royalties	Royalties: Royalties incurred in connection with the Company’s license agreement with Pfizer 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 acquired prior to receipt of marketing approval of a product candidate is recorded as research and development expense as incurred. Inventory that can be used in the production of either 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 September 30, 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 ASC 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 606, when its customer obtains control of the promised goods or services, an entity recognizes revenue 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 after the FDA approved NERLYNX in July 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 606, the entity performs the following five steps: (i) identifies the contract(s) with a customer, (ii) identifies the performance obligations in the contract, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations in the contract, and (v) recognizes revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net (below). Product Revenue, Net: The Company sells NERLYNX to a limited number of specialty pharmacies and specialty distributors in the United States. These customers subsequently resell the Company’s products to patients and certain medical centers or hospitals. In addition to distribution agreements with these customers, the Company enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the specialty pharmacy or specialty distributor, as applicable, obtains control of the Company's product, which occurs at a point in time (upon delivery). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 10 and 68 days. Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods, and are recorded in cost of sales. If taxes should be collected from these customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the three months ended September 30, 2018. Product revenue from customers who individually accounted for 10% or more of the Company’s total revenue for the three months ended September 30, 2018 consisted of the following, shown as a percentage of total revenue: Three Months Ended September 30, 2018 Customer A 35 % Customer B 27 % Customer C 14 % License Revenue: The Company also recognizes license revenue under certain of the Company’s license agreements that are within the scope of ASC 606. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. The Company evaluates these agreements under ASC 606 to determine the distinct performance obligations. Non-refundable, up-front 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. Variable consideration may include nonrefundable upfront license fees, payments for research and development activities, reimbursement of certain third-party costs, payments based upon the achievement of specified milestones, and royalty payments based on product sales derived from the collaboration. 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. The period between when the Company transfers control of the promised goods to a customer and when the Company receives payment from such customer is expected to be one year or less During the first quarter of 2018, the Company entered into sub-licensing agreements with CANbridge and Medison, to pursue regulatory approval and commercialize NERLYNX, if approved, in the People’s Republic of China (including mainland China, Hong Kong, Macao, and Taiwan) and Israel, respectively. The license agreements granted intellectual property rights and set forth the parties’ respective obligations with respect to development, commercialization and supply of the licensed product. For both license agreements, non-refundable, upfront license fees were received and recognized as license revenue in accordance with ASC 606. Each respective 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 both CANBridge and Medison with the licensed product in accordance with the respective supply agreements. These supply arrangements have been identified as separate performance obligations. The Company also identified the Joint Steering Committee as a separate, distinct performance obligation. To determine the respective stand-alone selling prices, the Company estimated the transaction prices, including any variable consideration, at contract inception and determined the fair value of such obligations based on similar arrangements. When determining the transaction prices, the Company assumed that the goods or services will be transferred to the customer based on the terms of the existing contract, and did not take into consideration the possibility of a contract being canceled, renewed, or modified. The Company noted there was no additional variable consideration, significant financing components, noncash consideration, or consideration payable to the customer in these agreements. 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 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 September 30, 2018 and, therefore, the transaction price was not reduced further during the quarter ended September 30, 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. However, 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 September 30, 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 available industry data and 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. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. 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 September 30, 2018 and December 31, 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): September 30, 2018 Level 1 Level 2 Level 3 Total Cash equivalents $ 50,176 $ 3,016 $ — $ 53,192 Commercial paper — 44,642 — 44,642 Corporate bonds — 12,043 — 12,043 US government 2,967 — — 2,967 $ 53,143 $ 59,701 $ — $ 112,844 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 September 30, 2018 (in years) cost Gains Losses fair value Cash equivalents $ 53,193 $ — $ (1 ) $ 53,192 Commercial paper Less than 1 44,642 — — 44,642 Corporate bonds Less than 1 12,045 — (2 ) 12,043 US government Less than 1 2,967 — — 2,967 $ 112,847 $ - $ (3 ) $ 112,844 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 September 30, 2018, were approximately $73.5 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 R&D expenses include clinical manufacturing costs, clinical trial expenses, consulting and other third-party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs. Clinical trial expenses include, but are not limited to, investigator fees, site costs, comparator drug costs, and clinical research organization, or CRO, costs. In the normal course of business, the Company contracts with third parties to perform various clinical trial activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variations from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients and the completion of portions of the clinical trial or similar conditions. The Company’s accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs. The objective of the Company’s accrual policy is to match the recording of expenses in the unaudited condensed consolidated financial statements to the actual services received and efforts expended. 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 unaudited condensed 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).
Income Taxes	Income Taxes: In accordance with ASC 740, Income Taxes Our income tax returns are based on calculations and assumptions subject to audit by various tax authorities. In addition, the calculation of our tax liabilities involves dealing with uncertainties in the application of complex tax laws. 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%. As a result of the Tax Act, the Company has revalued its net deferred tax assets as of December 31, 2017 to reflect the rate reduction. Tax rates used for the ASC 740 interim reporting reflect the newly enacted corporate tax rate of 21% and adjustments used for the estimated annual effective tax rate calculation reflect changes from the Tax Act. 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 was able to provide a reasonable estimate for the revaluation of deferred taxes by recording a net tax provision of $141.1 million in the period ending December 31, 2017, which is 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, expensing of qualified property and additional limitations on the deductibility of executive compensation are not expected to have a material impact to the financial statement presentation or disclosures. 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 September 30, 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.
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 Common Share: Basic net loss per common share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares 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)	9 Months Ended
	Sep. 30, 2018
Accounting Policies [Abstract]
Summary of Product Revenues from Customers	Product revenue from customers who individually accounted for 10% or more of the Company’s total revenue for the three months ended September 30, 2018 consisted of the following, shown as a percentage of total revenue: Three Months Ended September 30, 2018 Customer A 35 % Customer B 27 % Customer C 14 %
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 September 30, 2018 and December 31, 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): September 30, 2018 Level 1 Level 2 Level 3 Total Cash equivalents $ 50,176 $ 3,016 $ — $ 53,192 Commercial paper — 44,642 — 44,642 Corporate bonds — 12,043 — 12,043 US government 2,967 — — 2,967 $ 53,143 $ 59,701 $ — $ 112,844 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 September 30, 2018 (in years) cost Gains Losses fair value Cash equivalents $ 53,193 $ — $ (1 ) $ 53,192 Commercial paper Less than 1 44,642 — — 44,642 Corporate bonds Less than 1 12,045 — (2 ) 12,043 US government Less than 1 2,967 — — 2,967 $ 112,847 $ - $ (3 ) $ 112,844 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)	9 Months Ended
	Sep. 30, 2018
Banking And Thrift [Abstract]
Components of Prepaid Expenses and Other	Prepaid expenses and other consisted of the following (in thousands): September 30, 2018 December 31, 2017 Current: CRO services $ 6,113 $ 7,188 Other clinical development 1,176 878 Insurance 277 1,306 Other 4,817 3,625 12,383 12,997 Long-term: CRO services 1,480 860 Other clinical development 740 886 Insurance 26 26 Other 113 217 2,359 1,989 Totals $ 14,742 $ 14,986

Other Current Assets (Tables)

Other Current Assets (Tables)	9 Months Ended
	Sep. 30, 2018
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract]
Schedule of Other Current Assets	Other current assets consisted of the following (in thousands): September 30, 2018 December 31, 2017 Insurance receivable $ 11,232 $ — Other 263 $ — Totals $ 11,495 $ —

Property and Equipment (Tables)

Property and Equipment (Tables)	9 Months Ended
	Sep. 30, 2018
Property Plant And Equipment [Abstract]
Property and Equipment	Property and equipment consisted of the following (in thousands ): September 30, 2018 December 31, 2017 Property and Equipment: Leasehold improvements $ 4,047 $ 3,878 Computer equipment 2,402 2,147 Telephone equipment 343 302 Furniture and fixtures 2,346 2,206 9,138 8,533 Less: accumulated depreciation (4,898 ) (4,063 ) Totals $ 4,240 $ 4,470

Intangible assets, net (Tables)

Intangible assets, net (Tables)	9 Months Ended
	Sep. 30, 2018
Goodwill And Intangible Assets Disclosure [Abstract]
Schedule of Intangible assets, net	Intangible assets, net consisted of the following (dollars in thousands): September 30, 2018 Estimated useful life Acquired and in-licensed rights $ 50,000 13 Years Less: accumulated amortization (4,605 ) Total intangible asset, net $ 45,395

Accrued Expenses (Tables)

Accrued Expenses (Tables)	9 Months Ended
	Sep. 30, 2018
Payables And Accruals [Abstract]
Accrued Expenses	Accrued expenses consisted of the following (in thousands): September 30, 2018 December 31, 2017 Accrued CRO services 9,656 $ 8,335 Accrued royalties 7,893 3,922 Accrued variable consideration 5,953 1,425 Accrued bonus 5,759 3,376 Accrued compensation 4,437 2,797 Accrued legal fees 3,205 2,046 Accrued other clinical development 1,876 3,438 Other 2,738 5,309 Totals $ 41,517 $ 30,648

Debt (Tables)

Debt (Tables)	9 Months Ended
	Sep. 30, 2018
Debt Disclosure [Abstract]
Schedule of Long Term Debt	Long term debt consisted of the following at September 30, 2018 (dollars in thousands): September 30, 2018 Maturity Date Long term debt $ 125,000 May 1, 2023 Accretion of final interest payment 784 Less: deferred financing costs (4,730 ) Total long term debt, net $ 121,054

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	9 Months Ended
	Sep. 30, 2018
Equity [Abstract]
Employee Stock-based Compensation	Stock-based compensation was as follows for the three and nine months ended September 30 (in thousands except per share data): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2018 2017 2018 2017 Stock-based compensation: Options - Research and development $ 5,387 $ 15,825 $ 22,689 $ 54,062 Selling, general and administrative 3,132 5,817 11,721 18,371 Restricted stock units - Selling, general and administrative 6,280 2,513 15,228 4,595 Research and development 6,008 2,333 18,705 6,185 Total stock-based compensation expense $ 20,807 $ 26,488 $ 68,343 $ 83,213
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 –Significant Accounting Policies) with the following weighted-average assumptions used during the nine months ended September 30, 2018 and 2017. 2018 2017 Dividend yield 0.0 % 0.0 % Expected volatility 95.5 % 70.2 % Risk-free interest rate 2.5 % 2.0 % Expected life in years 5.85 5.83
Activity with Respect to Options Granted	Activity with respect to options granted under the 2011 Plan and 2017 Plan is summarized as follows: Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2017 6,134,513 $ 87.91 7.2 $ 220,060 Granted 225,566 $ 73.40 9.3 Forfeited (162,673 ) $ 53.78 Exercised (187,754 ) $ 35.70 $ 5,011 Expired (246,043 ) $ 122.38 Outstanding at September 30, 2018 5,763,609 $ 88.54 6.4 $ 38,856 Nonvested at September 30, 2018 893,980 $ 51.79 8.4 $ 4,361
Stock Options	The weighted-average grant date fair value of options granted during the nine months ended September 30, 2018 and 2017 was $56.46 and $24.30 per share, respectively. Weighted Average Grant-Date Stock options Shares Fair Value Nonvested shares at December 31, 2017 1,788,436 $ 33.37 Granted 225,566 $ 56.46 Vested/Issued (957,349 ) $ 37.90 Forfeited (162,673 ) $ 32.46 Nonvested shares at September 30, 2018 893,980 $ 34.49
Restricted Stock Units	The weighted average grant date fair value of RSUs awarded during the nine months ended September 30, 2018 was $62.11 and $79.82 per share, respectively. Weighted Average Grant-Date Restricted stock units Shares Fair Value Nonvested shares at December 31, 2017 1,637,662 $ 85.58 Granted 538,320 $ 62.11 Vested/Issued (332,173 ) $ 65.32 Forfeited (301,839 ) $ 84.88 Nonvested shares at September 30, 2018 1,541,970 $ 81.89

Business and Basis of Present_2

Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017	Dec. 31, 2017
Organization Consolidation And Presentation Of Financial Statements [Abstract]
Net loss	$ (14,201)	$ (77,180)	$ (82,880)	$ (227,877)
Net cash used in operating activities			(31,152)	$ (136,861)
Cash and cash equivalents	68,299		68,299		$ 81,698
Marketable securities	$ 59,652		$ 59,652

Significant Accounting Polici_4

Significant Accounting Policies - Additional Information (Detail)	3 Months Ended			9 Months Ended		12 Months Ended
	Sep. 30, 2018USD ($)shares	Mar. 31, 2018USD ($)Country	Sep. 30, 2017shares	Sep. 30, 2018USD ($)Segmentshares	Sep. 30, 2017shares	Dec. 31, 2017USD ($)
Significant Accounting Policies [Line Items]
Amortization expenses related to intangible assets	$ 1,000,000			$ 3,000,000
Estimated future amortization expense related to intangible assets, remainder of 2018	900,000			900,000
Estimated future amortization expense related to intangible assets, 2019	3,900,000			3,900,000
Estimated future amortization expense related to intangible assets, 2020	3,900,000			3,900,000
Estimated future amortization expense related to intangible assets, 2021	3,900,000			3,900,000
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
Incremental costs expenses	0			$ 0
Contract with customer, description				The period between when the Company transfers control of the promised goods to a customer and when the Company receives payment from such customer is expected to be one year or less
Cash and cash equivalents	68,299,000			$ 68,299,000		$ 81,698,000
Cash						13,900,000
Cash equivalents						$ 67,800,000
Cash and cash equivalents and restricted cash in excess of insured limits	$ 73,500,000			$ 73,500,000
Federal corporate income tax rate				21.00%		35.00%
Provisional tax impact related to the revaluation of deferred tax assets				$ 141,100,000
Number of segments | Segment				1
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	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	1,541,970		956,060	1,541,970	956,060
Employee Stock Option
Significant Accounting Policies [Line Items]
Anti-dilutive securities excluded from the calculation of diluted earnings per share | shares	5,763,609		6,295,192	5,763,609	6,295,192
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 | 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 - Sales Revenue, Net	3 Months Ended
	Sep. 30, 2018
Customer A
Significant Accounting Policies [Line Items]
Concentration risk percentage	35.00%
Customer B
Significant Accounting Policies [Line Items]
Concentration risk percentage	27.00%
Customer C
Significant Accounting Policies [Line Items]
Concentration risk percentage	14.00%

Assets Measured at Fair Value o

Assets Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents	$ 53,192	$ 67,753
Total	112,844	67,753
Commercial paper
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Marketable securities	44,642
Corporate bonds
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Marketable securities	12,043
US government
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Marketable securities	2,967
Level 1
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents	50,176	67,753
Total	53,143	$ 67,753
Level 1 | US government
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Marketable securities	2,967
Level 2
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents	3,016
Total	59,701
Level 2 | Commercial paper
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Marketable securities	44,642
Level 2 | Corporate bonds
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Marketable securities	$ 12,043

Summary of Short-term Investmen

Summary of Short-term Investments (Detail) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Schedule Of Available For Sale Securities [Line Items]
Amortized cost	$ 112,847	$ 67,753
Unrealized Losses	(3)
Estimated fair value	112,844	67,753
Cash Equivalents
Schedule Of Available For Sale Securities [Line Items]
Amortized cost	53,193	67,753
Unrealized Losses	(1)
Estimated fair value	$ 53,192	$ 67,753
Commercial paper
Schedule Of Available For Sale Securities [Line Items]
Maturity (in years)	Less than 1
Amortized cost	$ 44,642
Estimated fair value	$ 44,642
Corporate bonds
Schedule Of Available For Sale Securities [Line Items]
Maturity (in years)	Less than 1
Amortized cost	$ 12,045
Unrealized Losses	(2)
Estimated fair value	$ 12,043
US government
Schedule Of Available For Sale Securities [Line Items]
Maturity (in years)	Less than 1
Amortized cost	$ 2,967
Estimated fair value	$ 2,967

Components of Prepaid Expenses

Components of Prepaid Expenses and Other (Detail) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Prepaid Expenses [Line Items]
Prepaid expenses, and other, current	$ 12,383	$ 12,997
Prepaid expenses and other, long-term	2,359	1,989
Totals	14,742	14,986
CRO services
Prepaid Expenses [Line Items]
Prepaid expenses, and other, current	6,113	7,188
Prepaid expenses and other, long-term	1,480	860
Other clinical development
Prepaid Expenses [Line Items]
Prepaid expenses, and other, current	1,176	878
Prepaid expenses and other, long-term	740	886
Insurance
Prepaid Expenses [Line Items]
Prepaid expenses, and other, current	277	1,306
Prepaid expenses and other, long-term	26	26
Other
Prepaid Expenses [Line Items]
Prepaid expenses, and other, current	4,817	3,625
Prepaid expenses and other, long-term	$ 113	$ 217

Schedule of Other Current Asset

Schedule of Other Current Assets (Detail) $ in Thousands	Sep. 30, 2018USD ($)
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract]
Insurance receivable	$ 11,232
Other	263
Totals	$ 11,495

Property and Equipment (Detail)

Property and Equipment (Detail) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Property Plant And Equipment [Line Items]
Property, Plant and Equipment, Gross	$ 9,138	$ 8,533
Less: accumulated depreciation	(4,898)	(4,063)
Totals	4,240	4,470
Leasehold Improvements
Property Plant And Equipment [Line Items]
Property, Plant and Equipment, Gross	4,047	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, net (Detail) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Finite Lived Intangible Assets [Line Items]
Acquired and in-licensed rights	$ 50,000
Less: accumulated amortization	(4,605)
Total intangible asset, net	$ 45,395	$ 48,355
Acquired and in-licensed rights
Finite Lived Intangible Assets [Line Items]
Estimated useful life	13 years

Accrued Expenses (Detail)

Accrued Expenses (Detail) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Payables And Accruals [Abstract]
Accrued CRO services	$ 9,656	$ 8,335
Accrued royalties	7,893	3,922
Accrued variable consideration	5,953	1,425
Accrued bonus	5,759	3,376
Accrued compensation	4,437	2,797
Accrued legal fees	3,205	2,046
Accrued other clinical development	1,876	3,438
Other	2,738	5,309
Totals	$ 41,517	$ 30,648

Debt - Schedule of Long Term De

Debt - Schedule of Long Term Debt (Detail) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Debt Disclosure [Abstract]
Long term debt	$ 125,000
Accretion of final interest payment	784
Less: deferred financing costs	(4,730)
Total long term debt, net	$ 121,054	$ 48,477
Long term debt, maturity date	May 1, 2023

Debt - Additional Information (

Debt - Additional Information (Detail) - USD ($)	May 08, 2018	Oct. 31, 2017	Sep. 30, 2018
Debt Instrument [Line Items]
Aggregate principal amount			$ 125,000,000
Silicon Valley Bank and Oxford finance | Term Loan
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
Silicon Valley Bank and Oxford finance | Term Loan | Promissory Notes
Debt Instrument [Line Items]
Aggregate principal amount	$ 125,000,000
Silicon Valley Bank and Oxford finance | Term Loan | First Anniversary of Funding
Debt Instrument [Line Items]
Prepayment fee, percentage	3.00%
Silicon Valley Bank and Oxford finance | Term Loan | Between First Anniversary and Second Anniversary
Debt Instrument [Line Items]
Prepayment fee, percentage	2.00%
Silicon Valley Bank and Oxford finance | Term Loan | After Second Anniversary and Prior to May 1, 2023
Debt Instrument [Line Items]
Prepayment fee, percentage	1.00%
Silicon Valley Bank and Oxford finance | Term Loan | 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 Millions	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Stockholders Equity Note [Line Items]
Weighted-average grant date fair value of options granted	$ 56.46	$ 24.30
Non Vested Stock Options
Stockholders Equity Note [Line Items]
Estimated unrecognized employee compensation cost related to non-vested stock options granted	$ 25.5
Estimated unrecognized employee compensation cost related to non-vested stock options granted, Weighted-average period of recognition	1 year 6 months
RSUs
Stockholders Equity Note [Line Items]
Estimated unrecognized employee compensation cost related to non-vested stock options granted	$ 95.4
Estimated unrecognized employee compensation cost related to non-vested stock options granted, Weighted-average period of recognition	2 years 1 month 6 days
Weighted-average grant date fair value of restricted stock units	$ 62.11	$ 79.82
2011 Plan
Stockholders Equity Note [Line Items]
Common stock shares reserved for issuance	12,529,412
Share based compensation award, common stock are issuable upon the vesting of restricted stock unit awards	7,063,571
Common stock shares available for future issuance	2,662,245
2011 Plan | Maximum
Stockholders Equity Note [Line Items]
Stock options granted, term	10 years
2017 Employment Inducement Incentive Award Plan
Stockholders Equity Note [Line Items]
Common stock shares reserved for issuance	1,000,000
Share based compensation award, common stock are issuable upon the vesting of restricted stock unit awards	242,008
Common stock shares available for future issuance	694,295
2017 Employment Inducement Incentive Award Plan | Maximum
Stockholders Equity Note [Line Items]
Stock options granted, term	10 years

Stock-based Compensation (Detai

Stock-based Compensation (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total share-based compensation expense	$ 20,807	$ 26,488	$ 68,343	$ 83,213
Employee Stock Option | Research and development
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total share-based compensation expense	5,387	15,825	22,689	54,062
Employee Stock Option | Selling, general and administrative
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total share-based compensation expense	3,132	5,817	11,721	18,371
Restricted Stock Units | Research and development
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total share-based compensation expense	6,008	2,333	18,705	6,185
Restricted Stock Units | Selling, general and administrative
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total share-based compensation expense	$ 6,280	$ 2,513	$ 15,228	$ 4,595

Fair Value Options Weighted-Ave

Fair Value Options Weighted-Average Assumptions (Detail) - Employee Stock Option	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Dividend yield	0.00%	0.00%
Expected volatility	95.50%	70.20%
Risk-free interest rate	2.50%	2.00%
Expected life in years	5 years 10 months 6 days	5 years 9 months 29 days

Activity with Respect to Option

Activity with Respect to Options Granted (Detail) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Shares
Beginning balance, shares	6,134,513
Granted, shares	225,566
Forfeited, shares	(162,673)
Exercised, shares	(187,754)
Expired, shares	(246,043)
Ending balance, shares	5,763,609	6,134,513
Nonvested, shares	893,980	1,788,436
Weighted Average Exercise Price
Beginning Balance, Weighted Average Exercise Price	$ 87.91
Granted, Weighted Average Exercise Price	73.40
Forfeited, Weighted Average Exercise Price	53.78
Exercised, Weighted Average Exercise Price	35.70
Expired, Weighted Average Exercise Price	122.38
Ending Balance, Weighted Average Exercise Price	88.54	$ 87.91
Nonvested, Weighted Average Exercise Price	$ 51.79
Weighted Average Remaining Contractual Term (years)
Weighted Average Remaining Contractual Term (years)	6 years 4 months 24 days	7 years 2 months 12 days
Granted, Weighted Average Remaining Contractual Term (years)	9 years 3 months 18 days
Nonvested, Weighted Average Remaining Contractual Term (years)	8 years 4 months 24 days
Aggregate Intrinsic Value
Shares, Outstanding, Aggregate Intrinsic Value	$ 38,856	$ 220,060
Exercised, Aggregate Intrinsic Value	5,011
Nonvested, Aggregate Intrinsic Value	$ 4,361

Stock Options (Detail)

Stock Options (Detail) - $ / shares	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Shares
Nonvested shares, Beginning balance	1,788,436
Granted, shares	225,566
Vested/Issued, shares	(957,349)
Forfeited, shares	(162,673)
Nonvested shares, Ending balance	893,980
Weighted Average Grant-Date Fair Value
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value	$ 33.37
Granted, Weighted Average Grant-Date Fair Value	56.46	$ 24.30
Vested/Issued, Weighted Average Grant-Date Fair Value	37.90
Forfeited, Weighted Average Grant-Date Fair Value	32.46
Nonvested, Ending balance, Weighted Average Grant-Date Fair Value	$ 34.49

Restricted Stock Units (Detail)

Restricted Stock Units (Detail) - Restricted Stock Units - $ / shares	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Shares
Nonvested shares, Beginning balance	1,637,662
Granted, shares	538,320
Vested/Issued, shares	(332,173)
Forfeited, shares	(301,839)
Nonvested shares, Ending balance	1,541,970
Weighted Average Grant-Date Fair Value
Nonvested, Beginning balance, Weighted Average Grant-Date Fair Value	$ 85.58
Granted, Weighted Average Grant-Date Fair Value	62.11	$ 79.82
Vested/Issued, Weighted Average Grant-Date Fair Value	65.32
Forfeited, Weighted Average Grant-Date Fair Value	84.88
Nonvested, Ending balance, Weighted Average Grant-Date Fair Value	$ 81.89

401(K) Savings Plan - Additiona

401(K) Savings Plan - Additional Information (Detail) - USD ($) $ in Millions	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Defined Benefit Plan Disclosure [Line Items]
Employer matching contribution expenses	$ 1.3	$ 0.6
First 3% of each Participant's Contributions
Defined Benefit Plan Disclosure [Line Items]
Company's matching contributions to the 401(k)plan	100.00%
Second 2% of each Participant's Contributions
Defined Benefit Plan Disclosure [Line Items]
Company's matching contributions to the 401(k)plan	50.00%

Commitments and Contingencies -

Commitments and Contingencies - Additional Information (Detail) $ in Thousands	Sep. 30, 2018USD ($)	Jul. 10, 2018Officer	Apr. 14, 2016DerivativeLawsuit
Commitments And Contingencies Disclosure [Line Items]
Expects to receive reimbursement | $	$ 11,232
Number of stockholders derivative lawsuits | DerivativeLawsuit			2
Executive Officer
Commitments And Contingencies Disclosure [Line Items]
Number of officers filed motion for favorable judgment | Officer		2