DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2013 |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' |
Overview | ' |
Organization and Business |
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ANI Pharmaceuticals, Inc. and its consolidated subsidiary, ANIP Acquisition Company (together, the “Company”) is a specialty pharmaceutical company, developing and marketing generic and branded prescription products. The Company was organized as a Delaware corporation in April 2001. At its two facilities located in Baudette, Minnesota, which have a combined manufacturing, packaging and laboratory capacity totaling 173,000 square feet, the Company manufactures oral solid dose products, as well as liquids and topicals, including those that must be manufactured in a fully contained environment due to their potency. The Company also performs contract manufacturing for other pharmaceutical companies. |
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On June 19, 2013, BioSante Pharmaceuticals, Inc. (“BioSante”) acquired ANIP Acquisition Company (“ANIP”) in an all-stock, tax-free reorganization (the “Merger”) (Note 2), in which ANIP became a wholly-owned subsidiary of BioSante. BioSante was renamed ANI Pharmaceuticals, Inc. The Merger was accounted for as a reverse acquisition pursuant to which ANIP was considered the acquiring entity for accounting purposes. As such, ANIP's historical results of operations replace BioSante's historical results of operations for all periods prior to the Merger. The results of operations of both companies are included in the Company’s consolidated financial statements for all periods after completion of the Merger. |
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The Company's operations are subject to certain risks and uncertainties including, among others, current and potential competitors with greater resources, dependence on significant customers, lack of operating history and uncertainty of future profitability and possible fluctuations in financial results. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business. The propriety of using the going-concern basis is dependent upon, among other things, the achievement of future profitable operations, the ability to generate sufficient cash from operations, and potential other funding sources, including cash on hand, to meet the Company’s obligations as they become due. Management believes the going-concern basis is appropriate for the accompanying consolidated financial statements based on its current operating plan through December 31, 2014. |
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Basis of Presentation | ' |
Basis of Presentation |
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The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Certain prior period information has been reclassified to conform to the current period presentation. |
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Principles of consolidation | ' |
Principles of Consolidation |
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The consolidated financial statements include the accounts of ANI Pharmaceuticals, Inc. and its wholly-owned subsidiary, ANIP. All significant intercompany accounts and transactions are eliminated in consolidation. |
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Use of Estimates | ' |
Use of Estimates |
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The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, stock-based compensation, allowance for doubtful accounts, accruals for chargebacks, returns and other allowances, allowance for inventory obsolescence, valuation of derivative liabilities, accruals for contingent liabilities, fair value of long-lived assets, deferred taxes and valuation allowance, and the depreciable lives of fixed assets. Actual results could differ from those estimates. |
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Credit Concentration | ' |
Credit Concentration |
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The Company's customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and other pharmaceutical companies. |
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During the year ended December 31, 2013, three customers represented approximately 27%, 18%, and 10% of net revenues, respectively. As of December 31, 2013, accounts receivable from these customers totaled 68% of net accounts receivable. During the year ended December 31, 2012, three customers represented approximately 25%, 21%, and 11% of net revenues, respectively. |
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Vendor Concentration | ' |
Vendor Concentration |
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The Company sources the raw materials for its products, including active pharmaceutical ingredients (“API”), from both domestic and international suppliers. Generally, only a single source of API is qualified for use in each product due to the costs and time required to validate a second source of supply. As a result, the Company is dependent upon its current vendors to supply reliably the API required for ongoing product manufacturing. During the year ended December 31, 2013, the Company purchased approximately 37% of total costs of goods sold from three suppliers. As of December 31, 2013, amounts payable to these suppliers was immaterial. During the year ended December 31, 2012, the Company purchased approximately 63% of total costs of goods sold from three suppliers. |
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Revenue Recognition | ' |
Revenue Recognition |
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Revenue is recognized for product sales and contract manufacturing product sales upon passing of risk and title to the customer, when estimates of the selling price and discounts, rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments are reasonably determinable, collection is reasonably assured, and the Company has no further performance obligations. Contract manufacturing arrangements are typically less than two weeks in duration, and therefore the revenue is recognized upon completion of the aforementioned factors rather than using a proportional performance method of revenue recognition. The estimates for discounts, rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments reduce gross revenues to net revenues in the accompanying consolidated statements of operations, and are presented as current liabilities or reductions in accounts receivable in the accompanying consolidated balance sheets (see “Accruals for Chargebacks, Returns, and Other Allowances”). Historically, the Company has not entered into revenue arrangements with multiple elements. |
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Occasionally, the Company engages in contract services, which include product development services, laboratory services, and royalties on net sales of certain contract manufactured products. For these services, revenue is recognized according to the terms of the agreement with the customer, which sometimes include substantive, measurable risk-based milestones, and when the Company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured, and the Company has no further performance obligations under the agreement. The Company recognized $1.4 million and $0.8 million of revenue related to contract services in 2013 and 2012, respectively. |
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Cash and Cash Equivalents | ' |
Cash and Cash Equivalents |
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The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. All interest bearing and non-interest bearing accounts are guaranteed by the FDIC up to $250 thousand. The Company may maintain cash balances in excess of FDIC coverage. Management considers this to be a normal business risk. |
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In conjunction with the Merger, the Company acquired restricted cash, none of which remained at December 31, 2013. |
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Accounts Receivable | ' |
Accounts Receivable |
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The Company extends credit to customers on an unsecured basis. The Company utilizes the allowance method to provide for doubtful accounts based on management's evaluation of the collectability of accounts receivable, whereby the Company provides an allowance for doubtful accounts equal to the estimated uncollectible amounts. Management’s estimate is based on historical collection experience and a review of the current status of trade accounts receivable. The Company determines trade receivables to be delinquent when greater than 30 days past due. Receivables are written off when it is determined that amounts are uncollectible. The Company determined that no allowance for doubtful accounts was necessary as of December 31, 2013 and 2012. |
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Accruals for Chargebacks, Returns and Other Allowances | ' |
Accruals for Chargebacks, Returns and Other Allowances |
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The Company's generic and branded product revenues are typically subject to agreements with customers allowing chargebacks, product returns, administrative fees, and other rebates and prompt payment discounts. The Company accrues for these items at the time of sale based on the estimates and methodologies described below. In the aggregate, these accruals exceed 60% of generic and branded gross product sales and reduce gross revenues to net revenues in the accompanying consolidated statements of operations, and are presented as current liabilities or reductions in accounts receivable in the accompanying consolidated balance sheets. The Company continually monitors and re-evaluates the accruals as additional information becomes available, which includes, among other things, updates to trade inventory levels and customer product mix. The Company makes adjustments to the accruals at the end of each reporting period, to reflect any such updates to the relevant facts and circumstances. Accruals are relieved upon receipt of payment from or upon issuance of credit to the customer. |
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Chargebacks |
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Chargebacks, primarily from wholesalers, result from arrangements the Company has with indirect customers establishing prices for products which the indirect customer purchases through a wholesaler. Alternatively, the Company may pre-authorize wholesalers to offer specified contract pricing to other indirect customers. Under either arrangement, the Company provides a chargeback credit to the wholesaler for any difference between the contracted price with the indirect customer and the wholesaler's invoice price, typically Wholesale Acquisition Cost ("WAC"). |
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Chargeback credits are calculated as follows: |
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Prior period chargebacks claimed by wholesalers are analyzed to determine the actual average selling price ("ASP") for each product. This calculation is performed by product by wholesaler. ASPs can be affected by several factors such as: |
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| · | A change in customer mix | | | | | | | | | | | |
| · | A change in negotiated terms with customers | | | | | | | | | | | |
| · | A change in product sales mix | | | | | | | | | | | |
| · | A change in the volume of off-contract purchases | | | | | | | | | | | |
| · | Changes in WAC | | | | | | | | | | | |
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As necessary, the Company adjusts ASPs based on anticipated changes in the factors above. |
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The difference between ASP and WAC is recorded as a reduction in both gross revenues in the consolidated statements of operations and accounts receivable in the consolidated balance sheets, at the time the Company recognizes revenue from the product sale. |
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To evaluate the adequacy of its chargeback accruals, the Company obtains on-hand inventory counts from the wholesalers. This inventory is multiplied by the chargeback amount, the difference between ASP and WAC, to arrive at total expected future chargebacks, which is then compared to the chargeback accruals. The Company continually monitors chargeback activity and adjusts ASPs when it believes that actual selling prices will differ from current ASPs. |
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Returns |
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The Company maintains a return policy that allows customers to return product within a specified period prior to and subsequent to the expiration date. Generally, product may be returned for a period beginning six months prior to its expiration date to up to one year after its expiration date. The Company's product returns are settled through the issuance of a credit to the customer. The Company's estimate for returns is based upon its historical experience with actual returns. While such experience has allowed for reasonable estimation in the past, history may not always be an accurate indicator of future returns. The Company continually monitors its estimates for returns and makes adjustments when it believes that actual product returns may differ from the established accruals. Accruals for returns are recorded as a reduction to gross revenues in the consolidated statements of operations and as an increase to the return goods reserve in the consolidated balance sheets. |
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Administrative Fees and Other Rebates |
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Administrative fees or rebates are offered to wholesalers, group purchasing organizations and indirect customers. The Company accrues for fees and rebates, by product by wholesaler, at the time of sale based on contracted rates and ASPs. |
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To evaluate the adequacy of its administrative fee accruals, the Company obtains on-hand inventory counts from the wholesalers. This inventory is multiplied by the ASPs to arrive at total expected future sales, which is then multiplied by contracted rates. The result is then compared to the administrative fee accruals. The Company continually monitors administrative fee activity and adjusts its accruals when it believes that actual administrative fees will differ from the accruals. Accruals for administrative fees and other rebates are recorded as a reduction in both gross revenues in the consolidated statements of operations and accounts receivable in the consolidated balance sheets. |
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Prompt Payment Discounts |
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The Company often grants sales discounts for prompt payment. The reserve for sales discounts is based on invoices outstanding. The Company assumes based on past experience that all available discounts will be taken. Accruals for prompt payment discounts are recorded as a reduction in both gross revenues in the consolidated statements of operations and accounts receivable in the consolidated balance sheets. |
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The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the years ended December 31, 2013 and 2012: |
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(in thousands) | | Accruals for Chargebacks, Returns and Other Allowances | |
| | Chargebacks | | Returns | | Administrative | | Prompt | |
Fees and Other | Payment |
Rebates | Discounts |
Balance at December 31, 2011 | | $ | 3,681 | | $ | 252 | | $ | 238 | | $ | 166 | |
Accruals/Adjustments | | | 22,912 | | | 698 | | | 1,369 | | | 775 | |
Credits Taken Against Reserve | | | -20,931 | | | -539 | | | -1,376 | | | -699 | |
Balance at December 31, 2012 | | | 5,662 | | | 411 | | | 231 | | | 242 | |
Accruals/Adjustments | | | 28,009 | | | 1,595 | | | 2,355 | | | 1,129 | |
Credits Taken Against Reserve | | | -29,595 | | | -1,270 | | | -1,851 | | | -1,039 | |
Balance at December 31, 2013 | | $ | 4,076 | | $ | 736 | | $ | 735 | | $ | 332 | |
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Inventories | ' |
Inventories |
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Inventories consist of raw materials, packaging materials, work-in-progress, and finished goods. Inventories are stated at the lower of standard cost or net realizable value. The Company periodically reviews and adjusts standard costs, which generally approximates weighted average cost. |
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Property and Equipment | ' |
Property and Equipment |
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Property and equipment are recorded at cost. Expenditures for repairs and maintenance are charged to expense as incurred. Depreciation is recorded on a straight-line basis over estimated useful lives as follows: |
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Buildings and improvements | 20 - 40 years | | | | | | | | | | | | |
Machinery, furniture and equipment | 3 - 10 years | | | | | | | | | | | | |
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Construction in progress includes the cost of construction and other direct costs attributable to the construction, along with capitalized interest, if any. Depreciation is not recorded on construction in progress until such time as the assets are placed in service. |
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Management reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. Assets held for disposal are reportable at the lower of the carrying amount or fair value, less costs to sell. Management determined that no assets were impaired and no assets were held for disposal as of December 31, 2013 and 2012. |
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Intangible Assets | ' |
Intangible Assets |
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Intangible assets were acquired as part of the Merger and asset acquisition transactions and consist of rights to produce pharmaceutical products and a license. These intangible assets originally were recorded at fair value and are stated net of accumulated amortization. |
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The rights and licenses are amortized over their remaining estimated useful lives, ranging from 2 to 11 years, based on the straight-line method. Management reviews definite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable, in a manner similar to that for property and equipment. |
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Goodwill | ' |
Goodwill |
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Goodwill relates to the Merger and represents the excess of the total purchase consideration over the fair value of acquired assets and assumed liabilities, using the purchase method of accounting. Goodwill is not amortized, but is subject to periodic review for impairment. Goodwill is reviewed annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying amount of the goodwill might not be recoverable. The Company performs its review of goodwill on its one reporting unit. |
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Before employing detailed impairment testing methodologies, management first evaluates the likelihood of impairment by considering qualitative factors relevant to its reporting unit. When performing the qualitative assessment, management evaluates events and circumstances that would affect the significant inputs used to determine the fair value of the goodwill. Events and circumstances evaluated include: macroeconomic conditions that could affect the Company, industry and market considerations for the generic pharmaceutical industry that could affect the Company, cost factors that could affect the Company’s performance, the Company’s financial performance (including share price), and consideration of any Company-specific events that could negatively affect the Company, its business, or its fair value. If management determines that it is more likely than not that goodwill is impaired, management will then apply detailed testing methodologies. Otherwise, management will conclude that no impairment has occurred. |
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Detailed impairment testing involves comparing the fair value of the Company's one reporting unit to its carrying value, including goodwill. Fair value reflects the price a market participant would be willing to pay in a potential sale of the Company. If the fair value exceeds carrying value, then it is concluded that no goodwill impairment has occurred. If the carrying value of the reporting unit exceeds its fair value, a second step is required to measure possible goodwill impairment loss. The second step includes hypothetically valuing the tangible and intangible assets and liabilities of the Company's one reporting unit as if it had been acquired in a business combination. Then, the implied fair value of the Company's one reporting unit's goodwill is compared to the carrying value of that goodwill. If the carrying value of the Company's one reporting unit's goodwill exceeds the implied fair value of the goodwill, the Company recognizes an impairment loss in an amount equal to the excess, not to exceed the carrying value. |
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Collaborative Arrangements | ' |
Collaborative Arrangements |
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Third party costs incurred and revenues generated by arrangements involving the Company and one or more parties, both of whom are actively involved and exposed to risks and rewards of the activities, are classified in the consolidated statements of operations on a gross basis only if the Company is determined to be the principal participant in the arrangement. Otherwise, third party revenues and costs generated by collaborative arrangements are presented on a net basis. Payments between participants are recorded and classified based on the nature of the payments. |
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Research and Development Expense | ' |
Research and Development Expenses |
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Research and development costs are expensed as incurred and primarily consist of expenses relating to product development. Research and development costs totaled $1.7 million and $1.2 million for the years ended December 31, 2013 and 2012, respectively. |
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Stock-Based Compensation | ' |
Stock-Based Compensation |
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The Company has a stock-based compensation plan that includes stock options and restricted stock, which are awarded in exchange for employee and non-employee director services. The Company recognizes the estimated fair value of stock-based awards and classifies the expense where the underlying salaries are classified. For the year ended December 31, 2013, all stock-based awards were classified as sales, general and administrative expense in the accompanying consolidated statements of operations. Stock-based compensation cost for stock options is determined at the grant date using an option pricing model and stock-based compensation cost for restricted stock is based on the closing market price of the stock at the grant date. The value of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the employee's requisite service period. |
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Valuation of stock awards requires management to make assumptions and to apply judgment to determine the fair value of the awards. These assumptions and judgments include estimating the future volatility of the Company’s stock price, dividend yields, future employee turnover rates, and future employee stock option exercise behaviors. Changes in these assumptions can affect the fair value estimate. |
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Income Taxes | ' |
Income Taxes |
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The Company uses the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The measurement of a deferred tax asset is reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized. |
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Management uses a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return, as well as guidance on derecognition, classification, interest and penalties and financial statement reporting disclosures. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. The Company has not identified any uncertain income tax positions that could have a material impact to the consolidated financial statements. The Company is subject to taxation in various jurisdictions in the United States and remains subject to examination by taxing jurisdictions for the years 1998 and all subsequent periods due to the availability of net operating loss carryforwards. |
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The Company recognizes interest and penalties accrued on any unrecognized tax exposures as a component of income tax expense. The Company did not have any amounts accrued relating to interest and penalties as of December 31, 2013 and 2012. |
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The Company considers potential tax effects resulting from discontinued operations and records intra-period tax allocations, when those effects are deemed material. |
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Earnings (Loss) per Share | ' |
Earnings (Loss) per Share |
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Basic earnings (loss) per share is computed by dividing net income (loss) available to common shareholders by the weighted-average number of shares of common stock outstanding during the period. |
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For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common shareholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options, unvested restricted stock awards, and stock purchase warrants, using the treasury stock method. |
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For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of Class C Special stock, common stock options, unvested restricted stock awards, and warrants exercisable for common stock (and prior to the Merger, equity-linked securities, convertible preferred stock, and stock purchase warrants exercisable for preferred stock), which have been excluded from the computation of diluted earnings (loss) per share, were 2.7 million for both of the years ended December 31, 2013 and 2012. The Company’s unvested restricted shares contain non-forfeitable rights to dividends, and therefore are considered to be participating securities; the calculation of basic and diluted income (loss) per share excludes net income (but not net loss) attributable to the unvested restricted shares from the numerator and excludes the impact of those shares from the denominator. |
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For periods prior to the Merger, earnings per share cannot be calculated, as ANIP common shareholders did not receive consideration in the Merger. In a reverse merger, the weighted average shares outstanding used to calculate basic earnings per share for periods prior to the merger is the weighted average shares outstanding of the common shares of the accounting acquirer (in this case, ANIP) multiplied by the exchange ratio. In the Merger, only holders of ANIP’s Series D preferred stock received consideration. Because ANIP‘s common shareholders did not receive any consideration in the Merger, their exchange ratio is zero, creating a weighted average shares outstanding of zero for periods prior to the Merger. |
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As of December 31, 2013, the Company had 120 thousand common stock options, 50 thousand unvested restricted stock awards, and 686 thousand warrants exercisable for common stock outstanding. |
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Stock Splits and Other Reclassifications | ' |
Stock Splits and Other Reclassifications |
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In July 2013, the Company's Board of Directors and stockholders approved a resolution to effect a one-for-six reverse stock split of the Company's common stock and Class C Special stock with no corresponding change to the par values. The number of authorized shares of common stock, Class C Special stock and blank check preferred stock was reduced proportionally. Common stock and Class C Special stock for all periods presented have been adjusted retrospectively to reflect the one-for-six reverse stock split. |
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Redeemable Convertible Preferred Stock | ' |
Redeemable Convertible Preferred Stock |
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Prior to the Merger, the carrying value of ANIP’s redeemable convertible preferred stock was increased by the accretion of any related discounts and accrued but unpaid dividends so that the carrying amount would equal the redemption amount at the dates the stock became redeemable. ANIP’s Series A, B, C and D preferred stock was redeemable at the option of the holders, subject to certain additional requirements. All of ANIP’s Series D preferred stock was canceled and exchanged for shares of BioSante common stock and all of ANIP’s Series A, B and C preferred stock were canceled in conjunction with the Merger (Note 2). |
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Fair Value of Financial Instruments | ' |
Fair Value of Financial Instruments |
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The Company's consolidated balance sheets include various financial instruments (primarily cash and cash equivalents, prepaid expenses, accounts receivable, accounts payable, accrued expenses, borrowings under line of credit, and other current liabilities) that approximate fair value. Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include: |
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· Level 1—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. |
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· Level 2—Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. |
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· Level 3—Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. |
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See Note 6 for additional information regarding fair value. |
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Segment Information | ' |
Segment Information |
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The Company currently operates in a single business segment. |
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Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements |
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In February 2013, the Financial Accounting Standards Board (“FASB”) issued guidance related to additional reporting and disclosure of amounts reclassified out of accumulated other comprehensive income (“OCI”). Under this new guidance, companies will be required to disclose the amount of income or loss reclassified out of OCI to each respective line item on the income statement where net income is presented. The guidance allows companies to elect whether to disclose the reclassification in the notes to the financial statements, or on the face of the income statement. The adoption of this standard in 2013 did not have a material impact on the Company’s consolidated results of operations, cash flows or financial position. The Company does not have a Statement of Comprehensive Income because the Company has no Other Comprehensive Income. |
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In July 2012, the FASB issued accounting guidance to simplify the evaluation for impairment of indefinite-lived intangible assets. Under the updated guidance, an entity has the option of first performing a qualitative assessment to determine whether it is more likely than not that an indefinite-lived intangible asset is impaired before proceeding to the quantitative impairment test under which it would calculate the asset’s fair value. When performing the qualitative assessment, the entity must evaluate events and circumstances that may affect the significant inputs used to determine the fair value of the indefinite-lived intangible asset. The adoption of this standard in 2013 did not have a material impact on the Company’s consolidated results of operations, cash flows or financial position. |
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The Company has evaluated all issued and unadopted Accounting Standards Updates and believes the adoption of these standards will not have a material impact on its consolidated results of operations, financial position, or cash flows. |
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