SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2014 |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation |
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The consolidated financial statements represent the consolidation of the accounts of the Company and its subsidiaries in conformity with United States of America generally accepted accounting principles (“U.S. GAAP”). All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates |
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In preparing financial statements in conformity with U.S. GAAP, management is required 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, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include revenue recognition, valuing equity securities in share-based payments, estimating fair value of equity instruments recorded as derivative liabilities, estimating the fair value of net assets acquired in business combinations, estimating the useful lives of depreciable and amortizable assets, goodwill impairment, and estimating the fair value of long-lived assets to assess whether impairment charges may apply. |
Revenue Recognition | Revenue Recognition |
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Product sales as of December 31, 2014 consisted of sales of Chenodal®, Vecamyl, and Thiola®. Revenue from product sales is recognized when persuasive evidence of an arrangement exists, title to product and associated risk of loss have passed to the customer, the price is fixed or determinable, collection from the customer is reasonably assured, the Company has no further performance obligations, and returns can be reasonably estimated. The Company records revenue from product sales upon delivery to its customers. From January 1, 2014 through November 30, 2014, the Company sold Thiola®, Chenodal® and Vecamyl in the United States to a specialty pharmacy. Under this distribution model, the specialty pharmacy takes title of the inventory and sells directly to patients. As of December 1, 2014, the Company sold Thiola®, Chenodal® and Vecamyl in the United States and Canada through a specialty distributor. Under this distribution model, the Company records revenues when the distributor ships products to customers and such customers take title of the inventory. |
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Revenue from products sales is recorded net of applicable provisions for rebates under governmental programs (including Medicaid), distribution related fees, prompt pay discounts, product returns and other sales-related deductions. We review our estimates of rebates and other applicable provisions each period and record any necessary adjustments in the current period’s net product sales. |
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Deductions from Revenue |
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Government Rebates and Chargebacks: The Company estimates the rebates that we will be obligated to provide to government programs and deducts these estimated amounts from our gross product sales at the time the revenues are recognized. Allowances for government rebates and discounts are established based on actual payer information, which is reasonably estimated at the time of delivery, and the government-mandated discounts applicable to government-funded programs. |
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Distribution-Related Fees: The Company records distribution fees and other fees paid to its distributor as a reduction of revenue, unless the Company receives an identifiable and separate benefit for the consideration and the Company can reasonably estimate the fair value of the benefit received. If both conditions are met, the Company records the consideration paid to the distributor as an operating expense. Prior to December 1, 2014, the Company estimated and recorded distribution and related fees due to its customer based on gross sales and deducted the fees from gross product sales. After December 1, 2014, such fees are based on a per transaction model and are no longer deducted from revenue and are recorded in selling, general and administrative expenses in the Consolidated Statement of Operations since the distributor fees are in consideration of services received, the Company receives an identifiable and separate benefit for the consideration and the Company can reasonably estimate the fair value of the benefit received, such that the Company could purchase these services from a third party. |
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Allowances for Patient Assistance Programs: We provide financial assistance to patients whose insurance policies require them to pay high deductibles and co-pays. The cost of this assistance is established based on actual payer information, and is deducted from gross product sales at the time revenues are recognized. |
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Prompt Pay Discounts: The Company offers discounts to certain customers for prompt payments. The Company estimates these discounts based on customer terms, and expect that its customers will always take advantage of this discount. Therefore, as of December 1, 2014 the Company accrues 100% of the prompt pay discount that is based on the gross amount of each invoice for those customers at the time of sale. |
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Product Returns: Consistent with industry practice, the Company offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the product’s expiration date. The Company develops estimates for product returns based upon historical experience, shelf life of the product, and other relevant factors. If necessary, the Company’s estimates of product returns may be adjusted in the future based on actual returns experience, known or expected changes in the marketplace, or other factors. Based on the distribution model change at December 1, 2014, with sales directly to customers, the Company anticipates minimal returns in the future. |
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During the year ended December 31, 2014, one customer, Dohmen Life Sciences Services (“Dohmen”), the Company’s distributor accounted for 80% of the Company’s revenues. As of December 31, 2014, this same customer accounted for 26% of the Company’s accounts receivable. |
Research and Development Costs | Research and Development Costs |
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Research and development costs are expensed as incurred and include: salaries, benefits, bonus, stock-based compensation, license fees, milestone payments due under license agreements, costs paid to third-party contractors to perform research, conduct clinical trials, and develop drug materials and delivery devices; and associated overhead and facilities costs. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors, clinical research organizations (“CRO’s). Invoicing from third-party contractors for services performed can lag several months. We accrue the costs of services rendered in connection with third-party contractor activities based on our estimate of management fees, and costs associated with monitoring site and data management. |
Employee Stock-Based Compensation | Employee Stock-Based Compensation |
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The Company recognizes all employee share-based compensation as a cost in the financial statements. Equity-classified awards principally related to stock options and restricted stock units, or RSUs, are measured at the grant date fair value of the award. The Company determines grant date fair value of stock option awards using the Black-Scholes option-pricing model. The fair value of restricted stock awards are determined using the closing price of the Company’s common stock on the grant date. Expense is recognized over the requisite service period based on the number of options or shares expected to ultimately vest. Forfeitures are estimated at the date of grant and revised when actual or expected forfeiture activity differs materially from original estimates. Refer to Note 14 for a further discussion of share-based payments. |
Earnings (Loss) Per Share | Earnings (Loss) Per Share |
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We calculate our basic earnings per share by dividing net income by the weighted average number of shares outstanding during the period. The diluted earnings per share computation includes the effect, if any, of shares that would be issuable upon the exercise of outstanding stock options and restricted stock units, reduced by the number of shares which are assumed to be purchased by the Company from the resulting proceeds at the average market price during the year, when such amounts are dilutive to the earnings per share calculation. |
Cash and Cash Equivalents | Cash and Cash Equivalents |
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We consider all highly liquid short-term investments with an original maturity of three months or less to be cash equivalents. Due to the short-term maturity of such investments, the carrying amounts are a reasonable estimate of fair value. |
Marketable Securities | Marketable Securities |
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The Company accounts for marketable securities held as “available-for-sale” in accordance with ASC 320, “Investments Debt and Equity Securities” (“ASC 320”). The Company classifies these investments as current assets and carries them at fair value. Unrealized gains and losses are recorded as a separate component of stockholders’ equity as accumulated other comprehensive income (loss). Realized gains or losses on marketable security transactions are reported in earnings and computed using an average cost basis. Marketable securities are maintained at one financial institution and are governed by the Company’s investment policy as approved by our Board of Directors. Fair values of marketable securities are based on quoted market prices. Valuation of marketable securities are further described in Note 8. |
Securities Sold, Not Yet Purchased | Securities Sold, Not Yet Purchased |
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Effective November 2014, the Company no longer executes short sales for its investments as such practices are prohibited under the Company’s investment policy. As of December 31, 2013 and for first ten months of fiscal 2014, securities sold, not yet purchased consisted of marketable securities that the Company has sold short. In order to facilitate a short sale, the Company borrows the securities from another party and delivers the securities to the buyer. The Company was required to "cover" its short sale in the future through the purchase of the security in the market at the prevailing market price and deliver it to the counterparty from which it borrowed. The Company was exposed to a loss to the extent that the security price increased during the time from when the Company borrowed the security to when the Company purchased it in the market to cover the short sale. Securities sold, not yet purchased are presented on the consolidated balance sheets with gains and losses reported in realized and unrealized gains on marketable securities on the consolidated statement of operations and comprehensive loss. The Company recognized a gain of $0.5 million on securities sold, not yet purchased for the year ended December 31, 2014. |
Accounts Receivable, Net | Accounts Receivable, Net |
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Trade accounts receivable are recorded net of allowances for prompt payment and doubtful accounts. Allowances for rebate discounts are included in other current liabilities in the accompanying consolidated balance sheets. Estimates for allowances for doubtful accounts are determined based on existing contractual obligations, historical payment patterns and individual customer circumstances. The allowance for doubtful accounts was $0.1 million and $0 million at December 31, 2014 and 2013, respectively. There were no writeoffs of accounts receivable during fiscal 2014. |
Inventories and Related Reserves | Inventories and Related Reserves |
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Inventory is stated at the lower of cost or estimated net realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and writes down such inventory as appropriate. In addition, the Company's products are subject to strict quality control and monitoring which the Company’s manufacturers perform throughout their manufacturing process. The Company has one manufacturer for Chenodal and one manufacturer for Thiola. With respect to our sources, two suppliers accounted for approximately 17% of our aggregate purchases relating to the sales of Chenodal and 83% of our aggregate purchases relating to the sales of Thiola, representing a total of 100% of our purchases. The inventory reserve was $0.1 million and $0 at December 31, 2014 and 2013, respectively. There were no writeoffs of inventory during fiscal 2014. |
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Inventory, net of reserve, consists of the following at December 31, 2014: |
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Raw material | | $ | 314,425 | |
Finished goods | | | 486,082 | |
Total inventory | | $ | 800,507 | |
Property and Equipment, net | Property and Equipment, net |
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Property, plant and equipment are stated at cost net of accumulated depreciation. Depreciation is computed using the straight-line method over the related estimated useful lives as presented in the table below. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred. Property and equipment purchased for specific research and development projects with no alternative uses are expensed as incurred. |
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The major classifications of property and equipment, including their respective expected useful lives, consisted of the following: |
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Furniture and Equipment | 3 to 7 years | | | |
Leasehold improvements | Shorter of length of lease or life of the asset | | | |
Long-Lived Assets | Long-Lived Assets |
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The Company accounts for long-lived assets in accordance with ASC 360. Long-lived assets, other than goodwill, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets might not be recoverable. Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset, a significant change in the extent or manner in which an asset is used, or any other significant adverse change that would indicate that the carrying amount of an asset or group of assets may not be recoverable. Application of alternative assumptions, such as changes in estimate of future cash flows, could produce significantly different results. Because of the significance of the judgments and estimation processes, it is likely that materially different amounts could be recorded if we used different assumptions or if the underlying circumstances were to change. |
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For long-lived assets used in operations, impairment losses are only recorded if the asset’s carrying amount is not recoverable through its undiscounted, probability-weighted future cash flows. The Company measures the impairment loss based on the difference between the carrying amount and estimated fair value. |
Intangible Assets, Net | Intangible Assets, Net |
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Intangible assets with finite useful lives consist primarily of product rights, licenses and customer relationships which are amortized on a straight line basis over 10 to 20 years. Intangible assets with finite useful lives are reviewed for impairment and the useful lives are reassessed whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. |
Goodwill | Goodwill |
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Goodwill represents the future economic benefits arising from assets acquired in a business combination that are not individually identified and separately recognized. In 2011, the Company adopted the method of assessing goodwill for possible impairment permitted by Accounting Standards Update ("ASU") No. 2011-08, Intangibles – Goodwill and Other, as described in the following paragraph. The Company first assesses the qualitative factors for reporting units that carry goodwill. If the qualitative assessment results in a conclusion that it is more likely than not that the fair value of a reporting unit exceeds the carrying value, then no further testing is performed for that reporting unit. |
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When a qualitative assessment is not used, or if the qualitative assessment is not conclusive and it is necessary to calculate fair value of a reporting unit, then the impairment analysis for goodwill is performed at the reporting unit level using a two-step approach. The first step of the goodwill impairment test is used to identify potential impairment by comparing the fair value of a reporting unit with its carrying amount, including goodwill utilizing an enterprise-value based premise approach. If the fair value of the reporting unit exceeds its carrying value, step two does not need to be performed. If the fair value of the reporting unit is less than its carrying value, an indication of goodwill impairment exists for the reporting unit and the entity must perform step two of the impairment test (measurement). Under step two, an impairment loss is recognized for any excess of the carrying amount of the reporting unit’s goodwill over the implied fair value of that goodwill. The implied fair value of goodwill is determined by allocating the fair value of the reporting unit in a manner similar to a purchase price allocation and the residual fair value after this allocation is the implied fair value of the reporting unit goodwill. Fair value of the reporting unit is determined by using various valuation techniques including income (discounted cash flow), market and/or consideration of recent and similar purchase acquisition transactions. The Company performs its annual impairment review of goodwill on the first day of the fourth quarter and when a triggering event occurs between annual impairment tests. |
Income Taxes | Income Taxes |
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The Company follows ASC 740, Income Taxes, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences 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 reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the asset will not be realized. |
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The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC 740, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. ASC 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. The Company’s policy is to record estimated interest and penalty related to the underpayment of income taxes or unrecognized tax benefits as a component of its income tax provision. As of December 31, 2014 and December 31, 2013, the Company had recorded an indemnification asset with a corresponding liability in the amount of $1.5 million and $0, respectively, recorded as a liability for unrecognized tax uncertainties, included in other liability-long term in the consolidated balance sheets. |
Patents | Patents |
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The Company expenses external costs, such as filing fees and associated attorney fees, incurred to obtain issued patents and patent applications pending. The Company also expenses costs associated with maintaining and defending patents subsequent to their issuance in the period incurred. |
Derivative Instruments | Derivative Instruments |
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The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company evaluates all of its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then revalued at each reporting date, with changes in the fair value reported in the statements of operations. For stock-based derivative financial instruments, the Company calculates the fair value of the financial instruments using the Binomial Lattice options pricing model at inception and on each subsequent valuation date. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity is assessed at inception, the fair value of the warrants is evaluated at the end of each reporting period (see Note 6, Note 7 and Note 8). |
Treasury Stock | Treasury Stock |
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The Company records treasury stock at the cost to acquire it and includes treasury stock as a component of stockholders’ equity. |
Reclassifications | Reclassifications |
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Certain reclassifications have been made to the prior year financial statements in order to conform to the current year’s presentation. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements |
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From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption. |
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In May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-09, "Revenue from Contracts with Customers (Topic 606)," which is the new comprehensive revenue recognition standard that will supersede all existing revenue recognition guidance under GAAP. The standard's core principle is that a company will recognize revenue when it transfers promised goods or services to a customer in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. This ASU is effective for annual and interim periods beginning on or after December 15, 2016, and early adoption is not permitted. Companies will have the option of using either a full retrospective approach or a modified approach to adopt the guidance in the ASU. The Company is currently evaluating the impact of adopting this guidance. |
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In August 2014, the FASB issued Accounting Standards Update ASU No. 2014-15, “Presentation of Financial Statements-Going Concern (Subtopic 205-40) Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”, which requires management to evaluate, at each annual and interim reporting period, whether there are conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date the financial statements are issued and provide related disclosures. ASU 2014-15 is effective for annual periods ending after December 15, 2016 and interim periods thereafter. Early application is permitted. The adoption of ASU 2014-15 is not expected to have a material effect on the Company’s consolidated financial statements or disclosures. |