Basis of Presentation and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2013 |
Basis of Presentation and Significant Accounting Policies | ' |
Basis of Presentation | ' |
Basis of Presentation |
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The accompanying condensed consolidated financial statements are unaudited and have been prepared by TESARO in accordance with accounting principles generally accepted in the United States of America (“GAAP”). |
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The condensed consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries: TESARO UK Limited; TESARO Securities Corporation; and TESARO Development, Ltd. All significant intercompany balances and transactions have been eliminated. The Company currently operates in one business segment, which is the identification, acquisition, development and commercialization of oncology therapeutics and supportive care product candidates, and a single reporting and operating unit structure. |
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Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These interim financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position and results of operations for the interim periods ended September 30, 2012 and 2013. |
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The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full fiscal year. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2012 and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements |
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In March 2013, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2013-05, which requires a parent company to release any related cumulative translation adjustment into net income only if a sale or transfer results in the complete or substantially complete liquidation of the foreign entity in which the subsidiary or group of assets had resided. This guidance is effective prospectively for fiscal years beginning after December 15, 2013. Early adoption and retrospective application are permitted. The Company expects to adopt this guidance effective January 1, 2014 and does not expect this adoption to have a material effect on its condensed consolidated financial statements. |
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In July 2013, the FASB issued ASU No. 2013-11, which requires entities to present an unrecognized tax benefit, or a portion of an unrecognized tax benefit, as a reduction to a deferred tax asset for a net operating loss carryforward or a similar tax loss or a tax credit carryforward, unless certain conditions exist. This guidance is effective prospectively for fiscal years beginning after December 15, 2013. Early adoption and retrospective application are permitted. The Company expects to adopt this guidance effective January 1, 2014 and does not expect this adoption to have a material effect on its condensed consolidated financial statements. |
Use of Estimates and Assumptions | ' |
Use of Estimates and Assumptions |
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The preparation of condensed consolidated financial statements in accordance with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, other comprehensive income and related disclosures. The most significant estimates and assumptions are used in, among other things, estimating research and development expense accruals and stock-based compensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |
Cash and Cash Equivalents | ' |
Cash and Cash Equivalents |
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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 certificate of deposits, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. |
Fair Value of Financial Instruments | ' |
Fair Value of Financial Instruments |
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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 the investment credit quality. The hierarchy defines three levels of valuation inputs: |
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Level 1 inputs | | Quoted prices in active markets for identical assets or liabilities. | | | | | | | | | | | |
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Level 2 inputs | | Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. | | | | | | | | | | | |
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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. | | | | | | | | | | | |
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The following table presents information about the Company’s financial assets and liabilities that have been measured at fair value as of December 31, 2012 and September 30, 2013 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): |
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| | | | Quoted Prices in | | Significant Other | | Significant | |
Active Markets | Observable Inputs | Unobservable Inputs |
Description | | Total | | (Level 1) | | (Level 2) | | (Level 3) | |
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December 31, 2012 | | | | | | | | | |
Money market funds | | $ | 123,888 | | $ | 123,888 | | $ | — | | $ | — | |
| | $ | 123,888 | | $ | 123,888 | | $ | — | | $ | — | |
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September 30, 2013 | | | | | | | | | |
Money market funds | | $ | 155,797 | | $ | 155,797 | | $ | — | | $ | — | |
| | $ | 155,797 | | $ | 155,797 | | $ | — | | $ | — | |
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The carrying amounts of accounts payable and accrued expenses approximate their fair values due to their short-term maturities. |
Research and Development Expenses | ' |
Research and Development Expenses |
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Research and development costs are charged to expense as incurred and include: |
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· license fees related to the acquisition of in-licensed products, which are reported on the statements of operations as acquired in-process research and development; |
· employee-related expenses, including salaries, bonuses, benefits, travel and stock-based compensation expense; |
· expenses incurred under agreements with contract research organizations, investigative sites and research consortia in connection with the conduct of clinical trials and preclinical studies and related services, such as administrative, data management and biostatistics services; |
· the cost of acquiring, developing and manufacturing clinical trial and other research and development materials; |
· facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and |
· costs associated with other preclinical activities and regulatory operations. |
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Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by vendors on their actual costs incurred. 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 in the financial statements as prepaid or accrued research and development expenses. |
Acquired In-Process Research and Development Expense | ' |
Acquired In-Process Research and Development Expense |
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The Company has acquired the rights to develop and commercialize new product candidates. The up-front payments to acquire a new drug compound, as well as 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”, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. |
Stock-Based Compensation | ' |
Stock-Based Compensation |
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Stock-based compensation is recognized as expense for all stock-based awards based on estimated fair values. The Company determines equity-based compensation at the grant date using the Black-Scholes option pricing model. The value of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. The cumulative effect of any changes to the estimated forfeiture rates would be recognized as an adjustment to compensation cost in the period of the change. |