Basis of Presentation and Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States, or GAAP. See “ New Accounting Pronouncements - Recently Adopted ” below for a discussion of certain revisions to prior period financial statements made in connection with the Company’s adoption of new revenue recognition guidance retroactive to January 1, 2015. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the business of developing and commercializing safer and more effective oncology-focused therapeutics. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, other comprehensive loss and the related disclosures. Significant estimates in these consolidated financial statements include estimates made in connection with accrued research and development expenses, stock-based compensation expense, revenue, valuation of convertible notes, inventory, intangible assets and related amortization. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains its cash and cash equivalent balances primarily in the form of money market fund accounts with financial institutions that management believes are creditworthy. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no financial instruments with off-balance-sheet risk of loss. The Company also is subject to credit risk from its accounts receivable related to its product sales, collaborators and licenses. As part of its credit management policy, the Company performs ongoing credit evaluations of its customers, and the Company has not required collateral from any customer. The Company has not recorded any allowances for doubtful accounts at either December 31, 2016 or 2017. Foreign Currency A subsidiary’s functional currency is the currency of the primary economic environment in which the subsidiary operates; normally, that is the currency of the environment in which a subsidiary primarily generates and expends cash. In making the determination of the appropriate functional currency for a subsidiary, the Company considers cash flow indicators, local market indicators, financing indicators and the subsidiary’s relationship with both the parent company and other subsidiaries. For subsidiaries that are primarily a direct and integral component or extension of the parent entity’s operations, the U.S. dollar is the functional currency. For each foreign subsidiary with a functional currency other than the U.S. dollar, assets and liabilities are translated at current exchange rates at the balance sheet date. Revenue and expense items are translated at average foreign exchange rates for the period. Adjustments resulting from the translation of the financial statements of these subsidiaries into U.S. dollars are excluded from the determination of net loss and are recorded in accumulated other comprehensive loss, a separate component of stockholders’ equity. For foreign subsidiaries with the U.S. dollar as the functional currency, monetary assets and liabilities are re-measured into U.S. dollars at the current exchange rate on the balance sheet date. Nonmonetary assets and liabilities are re-measured into U.S. dollars at historical exchange rates. Revenue and expense items are translated at average exchange rates prevailing during each period. Consolidated realized and unrealized foreign currency transaction gains and losses are recorded in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. Consolidated realized and unrealized foreign currency transaction losses were negligible for the year ended December 31, 2015, and were $0.2 million and $0.5 million for the years ended December 31, 2016 and 2017, respectively. Revenue Recognition Effective January 1, 2017, the Company adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers , using the full retrospective transition method. Under this method, the Company has revised its consolidated financial statements for the years ended December 31, 2015 and 2016, and applicable interim periods within those years, as if Topic 606 had been effective for those periods. 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 Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts 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 Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for net product revenue and license, collaboration and other revenues, see Note 13, “ Revenue Recognition ”. Cash and Cash Equivalents The Company considers all highly-liquid investments with original or remaining maturity from the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in certificates of deposit, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. Restricted Cash Restricted cash consists of cash balances held as collateral for the Company’s employee credit card programs. Fair Value of Financial Instruments The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of investment credit quality. The hierarchy defines three levels of valuation inputs: Level 1 inputs Quoted prices in active markets for identical assets or liabilities Level 2 inputs Observable inputs other than Level 1 inputs, including quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active Level 3 inputs Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability The following table presents information about the Company’s financial assets and liabilities that have been measured at fair value at December 31, 2016 and 2017 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): December 31, 2016 Description Balance Sheet Classification Total Level 1 Level 2 Level 3 Assets: Money market funds Cash and cash equivalents $ 766,186 $ 766,186 $ — $ — Total assets $ 766,186 $ 766,186 $ — $ — December 31, 2017 Description Balance Sheet Classification Total Level 1 Level 2 Level 3 Assets: Money market funds Cash and cash equivalents $ 593,955 $ 593,955 $ — $ — Total assets $ 593,955 $ 593,955 $ — $ — The carrying amounts of accounts payable and accrued expenses approximate their fair values due to their short-term maturities. In September 2014, the Company issued $201.3 million aggregate principal amount of 3.00% convertible senior notes due October 1, 2021, or the Convertible Notes. Interest is payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2015. As of December 31, 2017, the carrying value of the Convertible Notes was $143.4 million, net of unamortized discount and debt issuance costs and the fair value of the principal amount was $499.1 million. As of December 31, 2017, the carrying value of the Company’s borrowing under its term loan agreement approximated its fair value, considering the short period of time since the December 6, 2017 borrowing date. The Convertible Notes and the term loan agreement are discussed in more detail in Note 7, “ Debt. ” Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the economic life of the asset or the remaining lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The following estimated useful lives were used to depreciate the Company’s assets: Estimated Useful Life Furniture and fixtures years Computer equipment and software years Manufacturing equipment years Leasehold improvements Shorter of the useful life or the remaining lease term Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized in income. The Company reviews long-lived assets when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of an asset’s book value to the estimated undiscounted future net cash flows that the asset is expected to generate. If the estimated future undiscounted net cash flows are less than the book value, the asset is considered to be impaired, and the impairment loss to be recognized in income is measured as the amount by which the book value of the asset exceeds its fair value, which is measured based on the estimated discounted future net cash flows that the asset is expected to generate. Research and Development Expenses Research and development costs are charged to expense as incurred and include: · employee-related expenses, including salaries, bonuses, benefits, travel and stock-based compensation expense; · fees and expenses incurred under agreements with contract research organizations, investigative sites, research consortia and other entities in connection with the conduct of clinical trials and preclinical studies and related services, such as administrative, data management, laboratory and biostatistics services; · the cost of acquiring, developing and manufacturing active pharmaceutical ingredients for product candidates that have not received regulatory approval, clinical trial materials and other research and development materials; · fees and costs related to regulatory filings and activities; · pre-commercial license fees and milestone payments related to the acquisition of in-licensed product candidates, which are reported on the statements of operations as acquired in-process research and development; · facilities, depreciation and other expenses, which include direct and allocated expenses for rent, utilities, maintenance of facilities, insurance and other supplies; and · other costs associated with clinical, preclinical, discovery and other research activities. Costs for certain development activities, such as clinical trials and manufacturing development activities, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, and information provided to the Company by its vendors on their actual costs incurred or level of effort expended. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as prepaid or accrued research and development expenses. Certain clinical development costs incurred by the Company with respect to its niraparib program are reimbursed as part of a collaborative research agreement with Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., or Merck. Cost-sharing amounts received by the Company are recorded as a reduction to research and development expenses. Acquired In-Process Research and Development Expense The Company has acquired the rights to develop and commercialize new product candidates. Up-front payments that relate to the acquisition of a new drug compound, as well as pre-commercial milestone payments, are immediately expensed as acquired in-process research and development in the period in which they are incurred, provided that the new drug compound did not also include processes or activities that would constitute a “business” as defined under GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. Milestone payments made to third parties subsequent to regulatory approval are capitalized as intangible assets and amortized over the estimated remaining useful life of the related product. Royalties owed on sales of the products licensed pursuant to the agreements are expensed in the period the related revenues are recognized. Advertising Expenses The costs of advertising are expensed as incurred and included in selling, general, and administrative expenses in the consolidated statements of operations and comprehensive loss. For the years ended December 31, 2015, 2016 and 2017, advertising expenses totaled $3.6 million, $9.2 million, and $21.1 million, respectively. Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Comprehensive loss consists of net loss and other comprehensive loss. Other comprehensive loss includes foreign currency translation adjustments and unrealized gains and losses on pension obligations. The following table presents changes in the components of accumulated other comprehensive loss (in thousands): Foreign currency translation adjustments Unrealized loss on pension liability Total Balance at December 31, 2015 $ — $ — $ — Other comprehensive (loss) income (142) (2,782) (2,924) Balance at December 31, 2016 (142) (2,782) (2,924) Other comprehensive (loss) income 401 (3,359) (2,958) Balance at December 31, 2017 $ 259 $ (6,141) $ (5,882) Income Taxes The Company accounts for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes , which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company determines its deferred tax assets and liabilities based on differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 was signed into law, resulting in significant changes to the U.S. corporate income tax system. For additional details regarding this act, see Note 10, “ Income Taxes ”. Stock-Based Compensation Expense Stock-based compensation is recognized as expense for each stock-based award based on its estimated fair value. The Company determines the fair value of each stock option award at its grant date using the Black-Scholes option pricing model. The Company determines the fair value of each restricted stock unit, or RSU, at its grant date based on the closing market price of the Company’s common stock on that date. The value of the award is recognized as expense on a straight-line basis over the requisite service period and is adjusted for pre-vesting forfeitures in the period in which the forfeitures occur. For stock awards that have a performance condition, the Company recognizes compensation expense based on its assessment of the probability that the performance condition will be achieved, using an accelerated attribution model, over the explicit or implicit service period. Inventory Inventories are stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. Prior to the regulatory approval of its product candidates, the Company incurs expenses for the manufacture of drug product that could potentially be available to support the commercial launch of its products. Until the first reporting period when regulatory approval has been received or is otherwise considered probable, the Company records all such costs as research and development expense. Inventory used in clinical trials is also expensed as research and development expense, when selected for such use. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded as a component of cost of product sales in the consolidated statements of operations and comprehensive loss. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. Intangible Assets The Company maintains definite-lived intangible assets related to milestone payments made to third parties subsequent to regulatory approval for acquired and in-licensed product candidates. These assets are amortized over their remaining useful lives, which are generally estimated to be the remaining patent life. If the Company’s estimate of the product’s useful life is shorter than the remaining patent life, then the shorter period is used. 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, with a cumulative catch-up of amortization expense for milestone payments that do not result in additional intellectual property rights and/or incremental cash flows. Amortization expense is recorded as a component of cost of sales in the consolidated statements of operations and comprehensive loss. The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the receipt of additional clinical or nonclinical data regarding one of the Company’s drug candidates or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information regarding potential sales for the drug. If impairment indicators are present or changes in circumstance suggest that impairment may exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. Net Loss Per Share Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. The Company’s potentially dilutive shares, which include outstanding stock options, Employee Stock Purchase Plan awards, unvested RSUs, and shares issuable upon conversion of the Convertible Notes, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. The following table presents amounts that were excluded from the calculation of diluted net loss per share, due to their anti-dilutive effect (in thousands): Years Ended December 31, 2015 2016 2017 Outstanding stock options 5,878 6,979 6,908 Unvested restricted stock units 60 760 1,159 Shares issuable upon conversion of Convertible Notes 492 3,765 2,695 6,430 11,504 10,762 In September 2014, the Company issued Convertible Notes, which provide in certain situations for the conversion of the outstanding principal amount of the Convertible Notes into shares of the Company’s common stock at a predefined conversion rate. See Note 7, “ Debt ”, for additional information. In conjunction with the issuance of the Convertible Notes, the Company entered into capped call option transactions, or Capped Calls, with certain counterparties. The Capped Calls are expected generally to reduce the potential dilution, and/or offset, to an extent, the cash payments the Company may choose to make in excess of the principal amount, upon conversion of the Convertible Notes. As provided by the terms of the indenture underlying the Convertible Notes, the Company has a choice to settle the conversion obligation for the Convertible Notes in cash, shares or any combination of the two. The Company currently intends to settle the par value of the Convertible Notes in cash and any excess conversion premium in shares. Accordingly, the par value of the Convertible Notes will not be included in the calculation of diluted income per share, but the dilutive effect of the conversion premium will be considered in the calculation of diluted net income per share using the treasury stock method. The Convertible Notes were convertible as of December 31, 2015, 2016 and 2017. The share figures in the table above represent the estimated incremental shares that would be issued, after the consideration of the Capped Calls, assuming conversion of all of the outstanding Convertible Notes as of the respective balance sheet date. New Accounting Pronouncements - Recently Adopted In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. This ASU supersedes the revenue recognition requirements in ASC Topic 605, Revenue Recognition , and creates a new Topic 606, Revenue from Contracts with Customers . In 2015 and 2016, the FASB issued additional ASUs related to Topic 606 that delayed the effective date of the guidance and clarified various aspects of the new revenue guidance, including principal versus agent considerations, identifying performance obligations, and licensing, and they include other improvements and practical expedients. The Company adopted this new standard on January 1, 2017 using the full retrospective transition method, and has elected to use the following practical expedients that are permitted under the rules of the adoption, which have been applied consistently to all contracts within all reporting periods presented: · For completed contracts that had variable consideration, the Company has used the transaction price at the date the contract was completed rather than estimating variable consideration amounts in the comparative reporting periods. Therefore, the Company did not need to estimate its discounts, returns, chargebacks, rebates, co-pay assistance and other allowances on product sales made in the comparative reporting periods. · For all reporting periods presented before January 1, 2017, the Company has not disclosed the amount of the transaction price allocated to the remaining performance obligations or an explanation of when the Company expects to recognize that amount as revenue. Impact of Adoption The Company, as a result of adopting Topic 606 on January 1, 2017, has revised its comparative financial statements for the prior years as if Topic 606 had been effective for those periods. As a result, the following financial statement line items for the years ended December 31, 2015 and 2016 were affected. Consolidated Statements of Operations and Comprehensive Loss Year Ended December 31, 2015 As revised As originally Effect of change Product revenue, net $ 2,026 $ - $ 2,026 License, collaboration and other revenues 2,012 317 1,695 Cost of sales – product 62 - 62 Loss from operations (232,383) (236,042) 3,659 Net loss (247,749) (251,408) 3,659 Net loss per share applicable to common stockholders - basic and diluted $ (6.29) $ (6.38) $ 0.09 Year Ended December 31, 2016 As revised As originally Effect of change Product revenue, net $ 5,174 $ 6,877 $ (1,703) License, collaboration and other revenues 52,844 37,946 14,898 Cost of sales – product 1,203 1,256 (53) Loss from operations (357,702) (370,950) 13,248 Net loss (374,224) (387,472) 13,248 Net loss per share applicable to common stockholders - basic and diluted $ (7.85) $ (8.13) $ 0.28 Consolidated Balance Sheets December 31, 2016 (in thousands) As revised As originally Effect of change Accounts receivable $ 6,195 $ 5,343 $ 852 Other current assets 10,515 8,919 1,596 Accrued expenses 68,700 68,271 429 Deferred revenue, current 95 288 (193) Deferred revenue, non-current 305 — 305 Customer deposit — 15,000 (15,000) Accumulated deficit $ (973,761) $ (990,668) $ 16,907 Consolidated Statements of Cash Flows Year Ended December 31, 2015 (in thousands) As revised As originally Effect of change Net loss $ (247,749) $ (251,408) $ 3,659 Adjustments to reconcile net loss to net cash used in operating activities: Accounts receivable (2,562) (679) (1,883) Other assets (3,639) (2,128) (1,511) Accrued expenses 20,077 19,646 431 Deferred revenues 92 788 (696) Cash and cash equivalents at beginning of period 256,861 — Cash and cash equivalents at end of period $ $ 230,146 $ — Year Ended December 31, 2016 (in thousands) As revised As originally Effect of change Net loss $ (374,224) $ (387,472) $ 13,248 Adjustments to reconcile net loss to net cash used in operating activities: Accounts receivable (3,634) (4,664) 1,030 Other assets (7,770) (7,685) (85) Accrued expenses 31,896 31,897 (1) Deferred revenues 309 14,501 (14,192) Cash and cash equivalents at beginning of period 230,146 — Cash and cash equivalents at end of period $ $ 785,877 $ — The most significant change above relates to the Company’s license, collaboration and other revenues and the impact of the potential payment to Zai Lab (Shanghai) Co., Ltd., or Zai Lab, upon exercise of the option to co-market niraparib in China, Hong Kong and Macao, or the China Territories. Under Topic 605, even though the Company believed the probability was remote that this option would be exercised, the Company had concluded that the contract price was not fixed or determinable under the revenue recognition criteria and accordingly no revenue had been previously recognized. Therefore, the upfront, non-refundable license fee of $15.0 million received by the Company in the fourth quarter of 2016 was deferred and recorded as a customer deposit as of December 31, 2016. Upon its adoption of Topic 606, the Company determined the probability was remote that it would exercise the option and accordingly, the potential future payments to Zai Lab had no impact on the transaction price. Further, the Company evaluated this option to co-market niraparib under Topic 606 and concluded that this option was not a repurchase right and accordingly recognized revenue in 2016 for the transaction price received as and when the performance obligations under this agreement were satisfied by the Company. In February 2018, the Company and Zai Lab entered into an amendment to the Collaboration, Development and License agreement between the parties, eliminating the Company’s co-marketing right. This amendment had no impact on the Company’s accounting conclusions under Topic 606. For further discussion of the adoption of this standard, see Note 13, “ Revenue Recognition ” and Note 14, “ License and Collaboration Agreements ”. In January 2017, the FASB issued ASU No. 2017-01, which clarifies the definition of a business. To be considered a business (instead of an asset), an acquisition would have to include an input and a substantive process that together significantly contribute to the ability to create outputs. The new guidance provides a framework to evaluate when an input and a substantive process are present (including for early stage companies that have not generated outputs). To be a business without outputs, there will now need to be an organized workforce. The new guidance narrows the definition of the term “outputs” to be consistent with how it is described in Topic 606. Under the final definition, an output is the result of inputs and substantive processes that provide goods or services to customers, other revenue, or investment income, such as dividends and interest. The new guidance is effective on a prospective basis for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, with early adoption permitted. The Company has elected to early adopt this ASU effective January 1, 2017. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements, although this guidance could impact its accounting conclusions for certain future transactions, such as in-licensing agreements. New Accounting Pronouncements - Recently Issued In February 2016, the FASB issued ASU No. 2016-02, a comprehensive new lease accounting standard, which provides revised guidance on accounting for lease arrangements by both lessors and lessees and requires lessees to recognize a lease liability and a right-of-use asset for most leases. The new guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with early adoption permitted. The new standard must be applied using a modified retrospective transition approach that requires application of the new guidance for all periods presented. The Company is currently in the process of evaluating the impact that the adoption of this guidance will have on its consolidated financial statements and related disclosures. In August 2016, the FASB issued ASU No. 2016-15, which is intended to simplify and clarify how certain transactions are classified in the statement of cash f |