Basis of Presentation and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2014 |
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 conformity with accounting principles generally accepted in the United States of America, or 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 intercompany balances and transactions have been eliminated in consolidation. 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 has 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 June 30, 2013 and 2014. |
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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, 2013 and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. |
New Accounting Pronouncements - Recently Adopted | ' |
New Accounting Pronouncements - Recently Adopted |
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In June 2014, the FASB issued ASU No. 2014-10, which eliminates the concept of a development stage entity, or DSE, in its entirety from GAAP. Under existing guidance, DSEs are required to report incremental information, including inception-to-date financial information, in their financial statements. A DSE is an entity devoting substantially all of its efforts to establishing a new business and for which either planned principal operations have not yet commenced or have commenced but there has been no significant revenues generated from that business. Entities classified as DSEs will no longer be subject to these incremental reporting requirements after adopting ASU No. 2014-10. ASU No. 2014-10 is effective for fiscal years beginning after December 15, 2014, with early adoption permitted. Retrospective application is required for the elimination of incremental DSE disclosures. Prior to the issuance of ASU No. 2014-10, the Company had met the definition of a DSE since its inception. The Company elected to adopt this ASU early, and therefore it has eliminated the incremental disclosures previously required of DSEs, starting with this Quarterly Report on Form 10-Q. |
New Accounting Pronouncements - Recently Issued | ' |
New Accounting Pronouncements - Recently Issued |
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In April 2014, the FASB issued ASU No. 2014-08, which amends guidance for reporting discontinued operations and disposals of components of an entity. The amended guidance requires that a disposal representing a strategic shift that has (or will have) a major effect on an entity’s operations and financial results or a business activity classified as held for sale should be reported as discontinued operations. The amendments also expand the disclosure requirements for discontinued operations and add new disclosure requirements for individually significant dispositions that do not qualify as discontinued operations. This guidance is effective prospectively for fiscal years beginning after December 15, 2014 (early adoption is permitted only for disposals that have not been previously reported). The Company does not expect the adoption of this guidance to have a material effect on its consolidated financial statements. |
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In May 2014, the FASB issued ASU No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. This ASU supersedes the revenue recognition requirements in Accounting Standards Codification Topic 605, Revenue Recognition, and creates a new Topic 606, Revenue from Contracts with Customers. This guidance is effective for fiscal years beginning after December 15, 2016, with early adoption not permitted. Two adoption methods are permitted: retrospectively to all prior reporting periods presented, with certain practical expedients permitted; or retrospectively with the cumulative effect of initially adopting the ASU recognized at the date of initial application. The Company has not yet determined which adoption method it will utilize or the effect that the adoption of this guidance will have on its consolidated financial statements. |
Use of Estimates | ' |
Use of Estimates |
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The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, other comprehensive income and the related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to accrued research and development expenses and stock-based compensation expense. 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. |
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 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 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 |
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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, 2013 and June 30, 2014 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): |
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| | | | December 31, 2013 | |
Description | | Balance Sheet Classification | | Total | | Level 1 | | Level 2 | | Level 3 | |
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Assets: | | | | | | | | | | | |
Money market funds | | Cash and cash equivalents | | $ | 128,801 | | $ | 128,801 | | $ | — | | $ | — | |
Total assets | | | | $ | 128,801 | | $ | 128,801 | | $ | — | | $ | — | |
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| | | | June 30, 2014 | |
Description | | Balance Sheet Classification | | Total | | Level 1 | | Level 2 | | Level 3 | |
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Assets: | | | | | | | | | | | |
Money market funds | | Cash and cash equivalents | | $ | 149,390 | | $ | 149,390 | | $ | — | | $ | — | |
Total assets | | | | $ | 149,390 | | $ | 149,390 | | $ | — | | $ | — | |
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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 and milestone payments related to the acquisition of in-licensed products, which are reported on the statements of operations as acquired in-process research and development; |
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· employee-related expenses, including salaries, bonuses, benefits, travel and stock-based compensation expense; |
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· 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; |
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· the cost of acquiring, developing and manufacturing active pharmaceutical ingredients, clinical trial materials and other research and development materials; |
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· facilities, depreciation and other expenses, which include direct and allocated expenses for rent, utilities, maintenance of facilities, insurance and other supplies; and |
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· other costs associated with clinical and 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 its 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 condensed consolidated balance sheets 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. Up-front payments that relate to the acquisition of 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”, as defined under GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. |
Stock-Based Compensation Expense | ' |
Stock-Based Compensation Expense |
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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 equity-based award at its 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 are accounted for as an adjustment to expense in the period of the change. |