4. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2014 |
Summary Of Significant Accounting Policies Policies | ' |
Principles of Consolidation | ' |
The unaudited condensed 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. |
Restatement of Previously Issued Financial Statements for Intangible Asset Stepped-Up Basis | ' |
In the first quarter of 2014, the Company determined that certain indefinite-lived intangible assets have finite lives. Management determined the Syntocinon License and Carbetocin Assets have estimated useful lives of 20 years. The impact of this item would have increased net income in 2013 by $2.5 million. As a result, the Company’s expense for its provision for income taxes was overstated for the year ended December 31, 2013. The Company has recorded a deferred tax benefit in the current period for the stepped-up basis of its intangible assets by $2.5 million, to account for the book/tax basis resulting from the Kyalin acquisition. The adjustment necessary to reflect such change is recorded in the first quarter of 2014. The Company’s management assessed the impact of such item on the financial statements and determined that the related correction in 2013 did not have a material impact on the Company’s financial statements for 2013. Therefore, the Company’s management determined that no restatement of prior filings is necessary. |
Restatement of Prior Quarters | ' |
In the fourth quarter of 2013, the Company discovered that certain warrants issued to a placement agent in connection with the Company’s February Private Placement were not recorded and certain consulting expenses were overstated in the Company’s condensed consolidated financial statements for the first quarter of 2013. The overstated expenses include costs related to the February 14, 2013 Private Placement Offering and costs associated with the Company’s consultants. The adjustments necessary to reflect such issuance were recorded in the fourth quarter of 2013. |
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| | 31-Mar-13 | |
| | As Reported | | | As Restated | |
Operating loss | | $ | (2,251 | ) | | $ | (1,886 | ) |
Non-operating loss | | | (2,492 | ) | | | (2,982 | ) |
Net loss | | | (4,743 | ) | | | (4,868 | ) |
Net loss per common share, basic and diluted | | $ | (0.44 | ) | | $ | (0.46 | ) |
Restatement of Previously Issued Financial Statements for Additional Disclosures | ' |
The Company also determined that its obligation to pay liquidated damages under a registration agreement that it entered into in connection with a financing transaction completed on February 14, 2013, which required the Company to cause a registration statement to be declared effective by the Securities and Exchange Commission by May 15, 2013, should have also been disclosed. Accordingly, the Company restated the condensed consolidated financial statements for the quarter ended March 31, 2013 to disclose that it allocated approximately $360,000 of the proceeds received in this financing transaction to a registration payment obligation that was deemed probable at the date that the financing transaction was completed. |
Accounts Receivable - Trade | ' |
The Company's trade accounts receivable represents amounts due from its customer. The Company monitors the financial performance and credit worthiness of its customer so that it can properly assess and respond to changes in its credit profile. The Company provides reserves against trade receivables for estimated losses that may result from a customer's inability to pay. Amounts determined to be uncollectible are written-off against the reserve. |
Inventory | ' |
Inventories are stated at the lower of cost or estimated 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 write down such inventories 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. |
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Inventory consists of the following at March 31, 2014: |
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| | 31-Mar-14 | | | | | |
Raw material | | $ | 207,900 | | | | | |
Finished goods | | | 141,230 | | | | | |
Total inventory | | $ | 349,130 | | | | | |
Income Taxes | ' |
The Company follows FASB 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. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. |
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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 FASB 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. FASB ASC 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. As of March 31, 2014 and December 31, 2013, the Company has $1,522,063, and $0, respectively, as a liability for unrecognized tax uncertainties. |
Revenue Recognition | ' |
Product sales consist of U.S. sales of Chenodal and Vecamyl. 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 customer. |
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The Company sells Chenodal and Vecamyl in the United States to a specialty pharmacy. Under this distribution model, the specialty pharmacy takes title of the inventory FOB shipping point and sells directly to patients. |
Government Rebates and Chargebacks | ' |
The Company estimates reductions to product sales for Medicaid programs, and for certain other qualifying federal and state government programs. Based upon the Company's contracts with government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience, and estimated payer mix, the Company estimates and records an allowance for rebates and chargebacks. The Company's liability for Medicaid rebates consists of estimates for claims that a state will make for a current quarter, claims for prior quarters that have been estimated for which an invoice has not been received, and invoices received for claims from prior quarters that have not been paid. The Company's customer charges the Company for the difference between what they pay for the products and the ultimate selling price. |
Distribution-Related Fees | ' |
The Company has written contracts with its customer that include terms for distribution-related fees. The Company estimates and records distribution and related fees due to its customer based on gross sales. |
Prompt Pay Discounts | ' |
The Company offers discounts to its customer for prompt payments. The Company estimates these discounts based on customer terms and historical experience, and expect that its customer will always take advantage of this discount. Therefore, the Company accrues 100% of the prompt pay discount that is based on the gross amount of each invoice, at the time of sale. |
Product Returns | ' |
Consistent with industry practice, the Company offers its customer a limited right to return product purchased directly from the Company, which is principally based upon the product's expiration date. Product returned is generally not resalable given the nature of the Company's products and method of administration. The Company develops estimates for product returns based upon historical experience, inventory levels in the distribution channel, shelf life of the product, and other relevant factors. The Company monitors product supply levels in the distribution channel, as well as sales by its customer to patients using product-specific data provided by its customer. 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. |
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During the quarter ended March 31, 2014, one customer accounted for 100% of the Company’s revenues and accounts receivable. |
Financial Instruments and Fair Value | ' |
The Company accounts for financial instruments in accordance with ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”). ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below: |
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Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; |
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Level 2 – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly; and |
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Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. |
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In estimating the fair value of the Company’s marketable securities available-for-sale and securities sold, not yet purchased, the Company used quoted prices in active markets (see Note 6 and Note 8). |
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In estimating the fair value of the Company’s derivative liabilities, the Company used the Binomial Lattice options pricing model at inception and on each subsequent valuation date (see Note 7 and Note 8). |
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In estimating the fair value of the Company’s contingent consideration, the Company used the comparable uncontrolled transaction (“CUT”) method. Based on the fair value hierarchy, the Company classified contingent consideration within Level 3 because valuation inputs are based on projected revenues discounted to a present value (see Note 8). |
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Financial assets with carrying values approximating fair value include cash as well as accounts receivable, deposits on license agreements. Financial liabilities with carrying values approximating fair value include accounts payable. |