DESCRIPTION OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2013 |
DESCRIPTION OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES [Abstract] | ' |
DESCRIPTION OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES | ' |
1. DESCRIPTION OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES |
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Raptor Pharmaceutical Corp. (the "Company" or "Raptor") is a biopharmaceutical company focused on developing and commercializing life-altering therapeutics that treat debilitating and often fatal diseases. |
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The Company's first product, PROCYSBI® (cysteamine bitartrate) delayed-release capsules ("PROCYSBI"), received approval from the U.S. Food and Drug Administration ("FDA") on April 30, 2013 for the management of nephropathic cystinosis in adults and children six years and older. The European equivalent, PROCYSBI gastro-resistant hard capsules of cysteamine (as mercaptamine bitartrate), received marketing authorization on September 6, 2013 from the European Commission ("EC") as an orphan medicinal product for the treatment of proven nephropathic cystinosis for marketing in the European Union ("EU"). PROCYSBI received 7 years and 10 years of market exclusivity as an orphan drug in the U.S. and the EU, respectively. The Company commenced commercial sales of PROCYSBI in the U.S. in mid-June 2013 and plans to launch PROCYSBI in the EU in the first half of 2014. Prior to the second quarter of 2013, the Company had been in its development stage. With FDA approval of PROCYSBI and the commencement of commercial sales in the second quarter of 2013, the Company was no longer considered to be in the development stage. In the near-term, the Company's ability to generate revenues is entirely dependent upon sales of PROCYSBI in the U.S. and the EU. |
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Raptor's pipeline also includes its proprietary delayed-release form of cysteamine (DR Cysteamine or "RP103") in Phase 2/3 development for Huntington's disease and RP103 in Phase 2b development for nonalcoholic fatty liver disease ("NAFLD") in children. Raptor's other preclinical programs are based upon novel drug candidates that are designed to treat primary liver cancer and various other diseases. |
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The Company is subject to a number of risks, including: the level of commercial sales of PROCYSBI in the U.S. and the ability to launch PROCYSBI in the EU; the uncertainty of whether the Company's research and development efforts will result in expanded indications for PROCYSBI or additional commercial products; competition from larger organizations; reliance on licensing the proprietary technology of others; dependence on key personnel; uncertain patent protection; and the need to raise capital through equity and/or debt financings. Funding may not be available when needed if at all or on terms acceptable to the Company. If the Company exhausts its cash reserves and is unable to obtain adequate financing, it may be required to curtail planned operating expenditures, including its development programs. |
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Change in Fiscal Year End |
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In December 2012, Raptor's board of directors approved a change in the Company's fiscal year end from August 31 to December 31, effective on December 31, 2012. The accompanying condensed consolidated financial statements cover the period from January 1, 2013 through September 30, 2013, representing the first nine months of Raptor's recently adopted fiscal year. The prior year's comparable nine-month period covers December 1, 2011 through August 31, 2012, which is reported on the basis of Raptor's previous fiscal year end. As a result of the change in Raptor's fiscal year end, the quarterly periods of Raptor's newly adopted fiscal year do not coincide with the historical quarterly periods that Raptor had previously reported. |
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Basis of Presentation |
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The accompanying condensed consolidated financial statements reflect the results of operations of Raptor and have been prepared in accordance with U.S. generally accepted accounting principles ("GAAP") pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnotes have been condensed or omitted pursuant to such rules and regulations. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements. In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments (including normal recurring adjustments) considered necessary for the fair presentation of the Company's consolidated financial position, results of operations and cash flows for the periods presented. The condensed consolidated balance sheet as of December 31, 2012 has been derived from the Company’s audited financial statements as of such date, but does not include all disclosures required by GAAP. This Form 10-Q/A should be read in conjunction with the audited financial statements and accompanying notes in the Company's Transition Report on Form 10-KT/A for the four-month period ended December 31, 2012, as amended. |
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The Company's condensed consolidated financial statements include the accounts of the Company's direct and indirect wholly owned subsidiaries, Raptor Pharmaceuticals Inc., formerly known as Raptor Therapeutics Inc. which merged with Raptor Discoveries Inc. in December 2012 prior to changing its name and Raptor European Products, LLC, such subsidiaries incorporated in Delaware on August 1, 2007, and February 14, 2012, respectively, and Raptor Pharmaceuticals Europe B.V. (domiciled in the Netherlands and formed on December 15, 2009), Raptor Pharmaceuticals France SAS (incorporated in France on October 30, 2012), Raptor Pharmaceuticals Germany GmbH (formed on September 28, 2013 and incorporated in Germany as a German company with limited liability on October 15, 2013) and RPTP European Holdings C.V. (located in the Grand Caymans and formed on February 16, 2012). All intercompany accounts have been eliminated. |
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Use of Estimates |
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The preparation of financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
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Revenue Recognition and Accounts Receivable |
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The Company recognizes revenue in accordance with the FASB ASC 605, Revenue Recognition, when the following criteria have been met: persuasive evidence of an arrangement exists; delivery has occurred and risk of loss has passed; the price is fixed or determinable and collectability is reasonably assured. The Company determines that persuasive evidence of an arrangement exists based on written contracts that define the terms of the arrangements. Pursuant to the contract terms, the Company determines when title to products and associated risk of loss has passed onto the customer. The Company assesses whether the fee is fixed or determinable based on the payment terms associated with the transaction and whether the sales price is subject to refund or adjustment. The Company assesses collectability based primarily on the customer's payment history and creditworthiness. |
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PROCYSBI is currently only available for distribution from the Company's U.S. specialty pharmacy partner, Accredo Health Group, Inc. ("Accredo"), which is currently the Company’s only customer and ships directly to patients. PROCYSBI is not available in retail pharmacies. Prior authorization of coverage level by patients' private insurance plans, our patient assistance program ("PAP") or government payors is a prerequisite to the shipment of PROCYSBI to patients. Revenue is recognized once the product has been shipped by the specialty pharmacy to patients because the Company is unable to reasonably estimate the third-party payor mix and resulting rebates based on its lack of sufficient historical data. Billings to the Company's distributor in advance of product shipment and delivery by the specialty pharmacy to patients are recorded as deferred revenues by the Company until such shipments to patients occur. |
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The Company records revenue net of expected returns, discounts, distributor fees, rebates, including those paid to U.S. government agencies. Allowances are recorded as a reduction of revenue at the time product sales are recognized. Allowances for government rebates and discounts are established based on the actual payor information, which is known at the time of shipment to patients, and the government-mandated discounts applicable to government-funded programs. The allowances are adjusted to reflect known changes in the factors that may impact such allowances in the quarter the changes are known. |
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Trade accounts receivable are recorded net of product sales allowances for prompt-payment discounts and chargebacks. Estimates for chargebacks and prompt-payment discounts are based on contractual terms and the Company's expectations regarding the utilization rates. |
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Inventories and Cost of Sales |
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Inventories are stated at the lower of cost or market price, with cost determined on a first-in, first-out basis. Inventories are reviewed periodically to identify slow-moving inventory based on sales activity, both projected and historical, as well as product shelf-life. Prior to the approval of PROCYSBI by the FDA on April 30 2013, the Company recorded the purchase of raw materials and the manufacturing costs relating to PROCYSBI as research and development expense. Subsequent to approval, the Company began capitalizing these costs as commercial inventory. As of September 30, 2013, net inventories were approximately $2.2 million, which consisted of $1.8 million of raw materials, $0.3 million of work-in-process and $0.5 million of finished goods, offset by a reserve allowance of $0.4 million. Upon launching PROCYSBI in mid-June 2013, the Company began recognizing cost of sales. During the second quarter ended June 30, 2013, the Company recorded a $0.4 million reserve as cost of sales expense representing commercial inventory that was capitalized subsequent to FDA approval but written off due to an unanticipated minor change in the finished product presentation. No write-off occurred in the third quarter. Cost of sales includes the cost of inventory sold and reserved, manufacturing and supply chain costs, product shipping and handling costs, amortization of licensing approval milestone payments and licensing royalties payable to the University of California, San Diego ("UCSD"). |
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Comprehensive Loss |
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The components of comprehensive loss include net loss and foreign currency translation adjustments. |
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Cash and Cash Equivalents |
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The Company considers all highly liquid investments with original maturities of three months or less, when purchased, to be cash equivalents. The Company maintains cash and cash equivalents, which consist principally of money market funds with high credit quality financial institutions. Such amounts exceed Federal Deposit Insurance Corporation insurance limits. Restricted cash represents compensating balances required by the Company's U.S. bank as collateral for credit cards. |
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Short-term Investments |
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The Company typically invests in short-term investments in high credit-quality funds in order to obtain higher yields on its cash available for investment. The Company had no short-term investments at September 30, 2013 compared to approximately $22.1 million at December 31, 2012. The Company regularly evaluates its short-term investment fund options and in the future may invest a portion of its cash and cash equivalents balance ($88.3 million as of September 30, 2013) in higher credit-quality and higher-yielding short-term investment funds. |
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Such investments are not insured by the Federal Deposit Insurance Corporation. The Company completed an evaluation of its investments and determined that it did not have any other-than-temporary impairments as of September 30, 2013 or December 31, 2012. |
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Functional Currency |
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The Company's consolidated functional currency is the U.S. dollar. Raptor Pharmaceuticals Europe B.V. ("BV"), Raptor Pharmaceuticals France SAS ("SAS") and RPTP European Holdings C.V. ("CV"), the Company's European subsidiaries and Cayman-based subsidiary, respectively, use the European Euro as their functional currency. At each quarter end, each foreign subsidiary's balance sheets are translated into U.S. dollars based upon the quarter-end exchange rate, while their statements of operations and comprehensive loss are translated into U.S. dollars based upon an average exchange rate. |
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Fair Value of Financial Instruments |
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The carrying amounts of certain of the Company's financial instruments including cash equivalents, restricted cash, accounts payable, accrued liabilities, note payable and capital lease liability approximate fair value due either to length of maturity or interest rates that approximate prevailing market rates. The warrant liability is carried at fair value which is determined using the Black-Scholes option valuation model at the end of each reporting period. |
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The Company uses a fair value approach to value certain assets and liabilities. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. The Company uses a fair value hierarchy, which distinguishes between assumptions based on market data (observable inputs) and an entity's own assumptions (unobservable inputs). The hierarchy consists of three levels: |
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| · | Level one - Quoted market prices in active markets for identical assets or liabilities; | | | | | | | | | | | | | | |
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| · | Level two - Inputs other than level one inputs that are either directly or indirectly observable; and | | | | | | | | | | | | | | |
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| · | Level three - Unobservable inputs developed using estimates and assumptions, which are developed by the reporting entity and reflect those assumptions that a market participant would use. | | | | | | | | | | | | | | |
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Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each quarter. Assets and liabilities measured at fair value on a recurring basis at September 30, 2013 and December 31, 2012 are summarized as follows: |
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Assets | | Level 1 | | | Level 2 | | | Level 3 | | | September 30, | |
2013 |
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Fair value of cash equivalents | | $ | 71,434 | | | $ | 0 | | | $ | 0 | | | $ | 71,434 | |
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Total | | $ | 71,434 | | | $ | 0 | | | $ | 0 | | | $ | 71,434 | |
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Liabilities | | | | | | | | | | | | | | | | |
Fair value of common stock warrants | | $ | 0 | | | $ | 0 | | | $ | 10,339 | | | $ | 10,339 | |
Total | | $ | 0 | | | $ | 0 | | | $ | 10,339 | | | $ | 10,339 | |
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Assets | | Level 1 | | | Level 2 | | | Level 3 | | | 31-Dec-12 | |
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Fair value of cash equivalents | | $ | 35,069 | | | $ | 0 | | | $ | 0 | | | $ | 35,069 | |
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Short-term investments | | | 22,096 | | | | 0 | | | | 0 | | | | 22,096 | |
Total | | $ | 57,165 | | | $ | 0 | | | $ | 0 | | | $ | 57,165 | |
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Liabilities | | | | | | | | | | | | | | | | |
Fair value of common stock warrants | | $ | 0 | | | $ | 0 | | | $ | 16,405 | | | $ | 16,405 | |
Total | | $ | 0 | | | $ | 0 | | | $ | 16,405 | | | $ | 16,405 | |
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See Note 5 for further discussion of the calculation of the fair value of the common stock warrant liability. |
Intangible Assets |
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Intangible assets primarily include the intellectual property and other rights relating to DR Cysteamine (developed as PROCYSBI/RP103), and an out-license acquired in a 2009 Merger. The other intangible assets related to PROCYSBI/RP103 are amortized using the straight-line method over the estimated useful life of 20 years, which is the life of the intellectual property patents. The 20-year estimated useful life is also based upon the typical development, approval, marketing and life cycle management timelines of pharmaceutical drug products. Intangible assets related to the out-license are amortized using the straight-line method over the estimated useful life of 16 years, which is the life of the intellectual property patents. |
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Segment Information |
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The Company has determined that it operates in only one segment, as it only reports profit and loss information on an aggregate basis to its chief operating decision maker. The Company’s long-lived assets maintained outside the U.S. are not material. |
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Fixed Assets |
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Fixed assets, which mainly consist of leasehold improvements, furniture and fixtures, lab equipment, computer hardware and software and capital lease equipment, are stated at cost. Depreciation is computed using the straight-line method over the related estimated useful lives, except for leasehold improvements and capital lease equipment, which are depreciated over the shorter of the useful life of the asset or the lease term. Significant additions and improvements that have useful lives estimated at greater than one year are capitalized, while repairs and maintenance are charged to expense as incurred. |
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Impairment of Goodwill and Long-Lived Assets |
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Goodwill represents the excess of purchase price over the fair value of tangible and identified intangible assets of businesses acquired. Goodwill is not amortized, but is evaluated for impairment on an annual basis or more often when impairment indicators are present. When an impairment analysis is performed, if deemed necessary, a write-down in valuation is recorded. |
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The Company has one reporting unit. Therefore, the Company’s consolidated net assets, including existing goodwill and other intangible assets, are considered to be the carrying value of the reporting unit. If the carrying value of the reporting unit is in excess of its fair value, an impairment may exist, and the Company must perform the second step of the analysis, in which the implied fair value of the goodwill is compared to its carrying value to determine the impairment charge, if any. If the estimated fair value of the reporting unit exceeds the carrying value of the reporting unit, goodwill is not impaired and no further analysis is required. |
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The Company makes judgments about the recoverability of purchased intangible assets with finite lives and other long-lived assets whenever events or changes in circumstances indicate that impairment may exist. Recoverability of purchased intangible assets with finite lives and other long-lived assets is measured by comparing the carrying amount of the asset to the future undiscounted cash flows the asset is expected to generate. Impairment, if any, is measured as the amount by which the carrying value exceeds the fair value of the impaired asset. |
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Accrued Liabilities |
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Accrued liabilities include estimates of certain expenses for which the Company has not yet been invoiced and which requires management's judgment in determining appropriate expenses to accrue. Although the Company believes its accrued liabilities reflect the best information available to it, the Company's actual expenses could differ from its estimates. |
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Common Stock Warrant Liabilities |
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The Company issued warrants that contain conditional obligations that may require the Company to transfer cash to settle the warrants upon the occurrence of certain fundamental transactions. Therefore, the Company has classified the warrants as liabilities. The Company re-measures the liability at the end of every reporting period with the change in value reported in the Company’s consolidated statements of operations and comprehensive loss. At the exercise date, the fair values of these warrants are re-measured and reclassified to equity. |
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Deferred Offering Costs |
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Deferred offering costs represent expenses incurred to raise equity capital related to financing transactions which have not yet been completed as of the balance sheet dates. |
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Note Payable and Debt Issuance Costs |
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Note payable consists of the Company's loan agreement with HealthCare Royalty Partners II, L.P. ("HC Royalty"), as lender, under which Raptor agreed to borrow $50.0 million in two $25.0 million tranches. The Company received the first tranche in December 2012 and the second tranche in May 2013. The loan bears interest at an annual fixed rate of 10.75% of outstanding principal and includes a synthetic royalty component based on net product sales, including PROCYSBI, in a calendar year. The fixed and royalty interest are recognized as interest expense as incurred. Debt issuance costs, which were capitalized and included in other long-term assets, are being amortized over the life of the loan using the interest method. |
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Research and Development Costs |
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Research and development costs are charged to expense as incurred. Research and development expenses include medical, clinical, regulatory and scientists' salaries and benefits, lab collaborations, preclinical studies, clinical trials, clinical trial materials, commercial drug manufacturing expenses prior to obtaining marketing approval, regulatory and clinical consultants, lab supplies, lab services, lab equipment maintenance and small equipment purchased to support the research laboratory, amortization of intangible assets and allocated human resources and facilities expenses. |
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Income Taxes |
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Income taxes are recorded under the liability method, under which deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Based on the weight of available evidence, including cumulative losses since inception and expected future losses, the Company has determined that it is more likely than not that the deferred tax asset amount will not be realized and therefore a full valuation allowance has been provided on the Company’s net deferred tax assets. |
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The Company identifies uncertain tax positions and discloses any potential tax liability on its financial statements. The Company recognizes interest and/or penalties related to income tax matters as a component of income tax expense. |
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As of September 30, 2013, there were no liabilities recorded related to uncertain tax positions and no accrued interest or penalties related to uncertain tax positions. |
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The Company files U.S. Federal, California, various other state income and other tax returns and various foreign country income tax returns. The Company is currently not subject to any income tax examinations. Due to the Company's net operating losses, generally all tax years remain open. |
Net Loss per Share |
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Net loss per share is calculated by dividing net loss by the weighted-average shares of common stock outstanding during the period. Diluted net income per share is calculated by dividing net income by the weighted-average shares of common stock outstanding and potential shares of common stock during the period. For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted net loss per share as their effect is anti-dilutive. Potentially dilutive securities include: |
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| | Nine months ended | | | | | | | | | |
(In thousands) | | 30-Sep-13 | | | 31-Aug-12 | | | | | | | | | |
Warrants to purchase common stock | | | 1,145 | | | | 5,188 | | | | | | | | | |
Options to purchase common stock | | | 8,230 | | | | 6,125 | | | | | | | | | |
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Total potentially dilutive securities | | | 9,375 | | | | 11,313 | | | | | | | | | |
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Net loss per share, basic and diluted, was $(0.29) and $(0.21) for the three months ended September 30, 2013 and August 31, 2012, respectively, and $(1.01) and $(0.56) for the nine months ended September 30, 2013 and August 31, 2012, respectively. |
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Stock Option Plan |
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Compensation cost related to the Company’s stock option plans is measured at the grant date based on the fair value of the equity instruments awarded and is recognized on a straight-line basis over the period during which an employee is required to provide service in exchange for the award, or the requisite service period, which is usually the vesting period. The Company recognizes expense associated with stock options issued to third parties, including consultants, based upon the fair values of such awards on the dates the awards vest. |
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Reclassifications |
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Certain amounts previously reported under specific financial statement captions have been reclassified to be consistent with the current period presentation. |