Document_And_Entity_Informatio
Document And Entity Information (USD $) | 12 Months Ended | |||
In Millions, except Share data, unless otherwise specified | Dec. 31, 2013 | Jun. 28, 2013 | Feb. 14, 2014 | Feb. 14, 2014 |
Common Stock [Member] | Class C Special Stock [Member] | |||
Document Information [Line Items] | ' | ' | ' | ' |
Entity Registrant Name | 'ANI PHARMACEUTICALS INC | ' | ' | ' |
Entity Central Index Key | '0001023024 | ' | ' | ' |
Current Fiscal Year End Date | '--12-31 | ' | ' | ' |
Entity Filer Category | 'Smaller Reporting Company | ' | ' | ' |
Trading Symbol | 'ANIP | ' | ' | ' |
Entity Common Stock, Shares Outstanding | ' | ' | 9,639,941 | 10,868 |
Document Type | '10-K | ' | ' | ' |
Amendment Flag | 'false | ' | ' | ' |
Document Period End Date | 31-Dec-13 | ' | ' | ' |
Document Fiscal Period Focus | 'FY | ' | ' | ' |
Document Fiscal Year Focus | '2013 | ' | ' | ' |
Entity Well-known Seasoned Issuer | 'No | ' | ' | ' |
Entity Voluntary Filers | 'No | ' | ' | ' |
Entity Current Reporting Status | 'Yes | ' | ' | ' |
Entity Public Float | ' | $36.80 | ' | ' |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current Assets | ' | ' |
Cash and cash equivalents | $11,105 | $11 |
Accounts receivable, net of $5,104 and $6,124 of adjustments for chargebacks and other allowances at December 31, 2013 and 2012, respectively | 12,513 | 5,432 |
Inventories, net | 3,518 | 2,810 |
Prepaid expenses | 580 | 313 |
Total Current Assets | 27,716 | 8,566 |
Property and Equipment, net | 4,537 | 4,880 |
Deferred loan costs, net | 0 | 217 |
Intangible assets, net | 10,409 | 85 |
Goodwill | 1,838 | 0 |
Total Assets | 44,500 | 13,748 |
Current Liabilities | ' | ' |
Accounts payable | 1,429 | 1,994 |
Accrued expenses | 1,326 | 927 |
Returned goods reserve | 736 | 411 |
Deferred revenue | 47 | 315 |
Borrowings under line of credit | 0 | 4,065 |
Total Current Liabilities | 3,538 | 7,712 |
Liabilities and Stockholders' Deficit | ' | ' |
Commitments and Contingencies (Note 14) | ' | ' |
Stockholders' Equity/(Deficit) | ' | ' |
Preferred Stock, $0.0001 par value, 1,666,667 shares authorized; 0 shares issued and outstanding at December 31, 2013 and 2012, respectively | 0 | 0 |
Treasury stock, 9,233 shares of common stock, at cost, at December 31, 2013 | -68 | 0 |
Additional paid-in capital | 89,501 | 1,083 |
Accumulated deficit | -48,472 | -43,798 |
Total Stockholders' Equity/(Deficit) | 40,962 | -42,715 |
Total Liabilities and Stockholders' Equity/(Deficit) | 44,500 | 13,748 |
Redeemable Convertible Preferred Stock | ' | ' |
Redeemable Convertible Preferred Stock | ' | ' |
Redeemable Convertible Preferred Stock (Note 9) | 0 | 48,751 |
Common stock | ' | ' |
Stockholders' Equity/(Deficit) | ' | ' |
Common Stock Value | 1 | 0 |
Total Stockholders' Equity/(Deficit) | 1 | 0 |
Class C special stock | ' | ' |
Stockholders' Equity/(Deficit) | ' | ' |
Common Stock Value | 0 | 0 |
Total Stockholders' Equity/(Deficit) | $0 | $0 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets [Parenthetical] (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, except Share data, unless otherwise specified | ||
Adjustments for chargebacks and other allowances | $5,104 | $6,124 |
Treasury Stock, Shares | 9,233 | ' |
Preferred Stock, Par or Stated Value Per Share | $0.00 | $0.00 |
Preferred Stock, Shares Authorized | 1,666,667 | 1,666,667 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common stock | ' | ' |
Common Stock, Par Value (in dollars per share) | $0.00 | $0.00 |
Common Stock, Authorized Shares | 33,333,334 | 33,333,334 |
Common Stock, Issued Shares | 9,629,174 | 4,070,373 |
Common Stock, Outstanding Shares | 9,619,941 | 4,070,373 |
Class C special stock | ' | ' |
Common Stock, Par Value (in dollars per share) | $0.00 | $0.00 |
Common Stock, Authorized Shares | 781,281 | 781,281 |
Common Stock, Issued Shares | 10,868 | 10,868 |
Common Stock, Outstanding Shares | 10,868 | 10,868 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 12 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | |
Net Revenues | $30,082 | $20,371 | |
Operating Expenses | ' | ' | |
Cost of sales (excluding depreciation and amortization) | 9,974 | 9,167 | |
Research and development | 1,712 | 1,158 | |
Selling, general and administrative | 16,388 | 9,521 | |
Depreciation and amortization | 1,110 | 567 | |
Total Operating Expenses | 29,184 | 20,413 | |
Operating Income/(Loss) from Continuing Operations | 898 | -42 | |
Other Expense | ' | ' | |
Interest expense | -467 | -1,327 | |
Other expense | -305 | -241 | |
Net Income/(Loss) from Continuing Operations Before Benefit for Income Taxes | 126 | -1,610 | |
(Provision)/Benefit for income taxes | -20 | 36 | |
Net Income/(Loss) from Continuing Operations | 106 | -1,574 | |
Discontinued Operation | ' | ' | |
Gain on discontinued operation, net of provision (benefit) for income taxes | 195 | 68 | |
Net Income/(Loss) | 301 | -1,506 | |
Computation of Income/(Loss) from Continuing Operations Attributable to Common Stockholders: | ' | ' | |
Net Income/(Loss) from Continuing Operations | 106 | -1,574 | |
Preferred stock dividends | -4,975 | -6,922 | |
(Loss) from Continuing Operations Attributable to Common Stockholders | ($4,869) | ($8,496) | |
Basic and Diluted Income/(Loss) Per Share: | ' | ' | |
Continuing operations (in dollars per share) | ($0.96) | $0 | [1] |
Discontinued operation (in dollars per share) | $0.04 | $0 | [1] |
Basic and Diluted Income/(Loss) Per Share (in dollars per share) | ($0.92) | $0 | [1] |
Basic and Diluted Weighted-Average Shares Outstanding (in shares) | 5,071 | 0 | [1] |
[1] | Earnings per common share is not calculable because common shareholders from ANIP Acquisition Company did not receive consideration from the June 19, 2013 Merger with BioSante. See Note 1 for further details. |
Consolidated_Statements_of_Cha
Consolidated Statements of Changes in Stockholder's Equity/(Deficit) (USD $) | Total | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Common Stock [Member] | Class C Special Stock [Member] |
In Thousands | ||||||
Balance at Dec. 31, 2011 | ($34,284) | $1,086 | $0 | ($35,370) | $0 | $0 |
Balance (in shares) at Dec. 31, 2011 | ' | ' | 0 | ' | 3,045 | ' |
Issuance of common stock upon cashless warrant exercise | 0 | -2 | 0 | 0 | 2 | 0 |
Issuance of common stock upon cashless warrant exercise (in shares) | ' | ' | 0 | ' | 22 | ' |
Issuance of preferred stock upon cashless warrant exercise | -3 | -3 | 0 | 0 | 0 | 0 |
Preferred stock dividends | -6,922 | 0 | 0 | -6,922 | 0 | 0 |
Effect of Reverse Merger | 0 | 2 | 0 | ' | -2 | 0 |
Effect of Reverse Merger (in shares) | ' | ' | 0 | ' | 1,003 | ' |
Net Income | -1,506 | 0 | 0 | -1,506 | 0 | 0 |
Balance at Dec. 31, 2012 | -42,715 | 1,083 | 0 | -43,798 | 0 | 0 |
Balance (in sharess) at Dec. 31, 2012 | ' | ' | 0 | ' | 4,070 | ' |
Preferred stock dividends | -4,975 | 0 | 0 | -4,975 | 0 | 0 |
Non-cash Compensation Relating to Business Combination | 4,418 | 4,418 | 0 | 0 | 0 | 0 |
Cancellation of Convertible Preferred Stock | 53,726 | 53,726 | 0 | 0 | 0 | 0 |
Shares Issued in Merger | 29,795 | 29,794 | 0 | 0 | 1 | 0 |
Shares Issued in Merger (in shares) | ' | ' | 0 | ' | 5,469 | ' |
Stock-based Compensation Expense | 36 | 36 | 0 | 0 | 0 | 0 |
Purchase of Common Stock for Treasury | -433 | 0 | -433 | 0 | 0 | 0 |
Purchase of Common Stock for Treasury (in shares) | ' | ' | 59 | ' | 0 | ' |
Issuance of common stock upon warrant exercise | 809 | 809 | 0 | 0 | 0 | 0 |
Issuance of common stock upon warrant exercise (in shares) | ' | ' | ' | ' | 90 | ' |
Treasury stock shares issued as Restricted Stock | 0 | -365 | 365 | 0 | 0 | 0 |
Treasury Stock Shares Issued as Restricted Stock (in shares) | ' | ' | -50 | ' | 0 | ' |
Net Income | 301 | 0 | 0 | 301 | 0 | 0 |
Balance at Dec. 31, 2013 | $40,962 | $89,501 | ($68) | ($48,472) | $1 | $0 |
Balance (in sharess) at Dec. 31, 2013 | ' | ' | 9 | ' | 9,629 | ' |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Cash Flows From Operating Activities | ' | ' |
Net income/(loss) | $301 | ($1,506) |
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities: | ' | ' |
Stock-based compensation | 36 | 0 |
Depreciation and amortization | 1,110 | 567 |
Non-cash interest relating to equity-linked securities and loan cost amortization | 217 | 1,071 |
Non-cash compensation relating to business combination | 4,418 | 0 |
Changes in operating assets and liabilities, net of those acquired in business combination: | ' | ' |
Accounts receivable | -7,081 | -327 |
Inventories | -708 | -702 |
Prepaid expenses | -188 | -88 |
Accounts payable | -565 | 785 |
Accrued compensation | -2,854 | 0 |
Accrued expenses, returned goods reserve and deferred revenue | 25 | 205 |
Net Cash and Cash Equivalents Used in Continuing Operations | -5,289 | 5 |
Net Cash Used in Discontinued Operation | -195 | -142 |
Net Cash and Cash Equivalents Used in Operating Activities | -5,484 | -137 |
Cash Flows From Investing Activities | ' | ' |
Cash acquired in business combination | 18,198 | 0 |
Release of restricted cash | 2,260 | 0 |
Acquisition of property and equipment | -191 | -292 |
Net Cash and Cash Equivalents Provided by/(Used in) Investing Activities | 20,267 | -292 |
Cash Flows From Financing Activities | ' | ' |
(Repayments)/borrowings under line of credit, net | -4,065 | 1,001 |
Payment of debt issuance costs | 0 | -261 |
Proceeds from warrant exercise | 809 | 0 |
Treasury stock purchases | -433 | 0 |
Net Cash and Cash Equivalents (Used in)/Provided by Continuing Operations | -3,689 | 740 |
Net Cash Used in Discontinued Operation | 0 | -300 |
Net Cash and Cash Equivalents (Used in)/Provided by Financing Activities | -3,689 | 440 |
Change in Cash and Cash Equivalents | 11,094 | 11 |
Cash and cash equivalents, beginning of period | 11 | 0 |
Cash and cash equivalents, end of period | 11,105 | 11 |
Supplemental disclosure for cash flow information: | ' | ' |
Cash paid for interest | 250 | 255 |
Supplemental non-cash investing and financing activities: | ' | ' |
Issuance of common stock in connection with business combination | 40,034 | 0 |
Cancellation of Series D, Series C, Series B, and Series A preferred stock | 53,726 | 0 |
Acquired non-cash net assets | 11,597 | 0 |
Preferred stock dividends accrued | 4,975 | 6,922 |
Issuance of common and preferred stock upon cashless warrant exercise | 0 | 5 |
Issuance of preferred stock upon convertible debt conversion | $0 | $17,610 |
DESCRIPTION_OF_BUSINESS_AND_SU
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended | |||||||||||||
Dec. 31, 2013 | ||||||||||||||
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | |||||||||||||
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | |||||||||||||
1. DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||||||||||||
Organization and Business | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Basis of Presentation | ||||||||||||||
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. | ||||||||||||||
Principles of Consolidation | ||||||||||||||
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. | ||||||||||||||
Use of Estimates | ||||||||||||||
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. | ||||||||||||||
Credit Concentration | ||||||||||||||
The Company's customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and other pharmaceutical companies. | ||||||||||||||
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. | ||||||||||||||
Vendor Concentration | ||||||||||||||
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. | ||||||||||||||
Revenue Recognition | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Cash and Cash Equivalents | ||||||||||||||
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. | ||||||||||||||
In conjunction with the Merger, the Company acquired restricted cash, none of which remained at December 31, 2013. | ||||||||||||||
Accounts Receivable | ||||||||||||||
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. | ||||||||||||||
Accruals for Chargebacks, Returns and Other Allowances | ||||||||||||||
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. | ||||||||||||||
Chargebacks | ||||||||||||||
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"). | ||||||||||||||
Chargeback credits are calculated as follows: | ||||||||||||||
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: | ||||||||||||||
· | 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 | |||||||||||||
As necessary, the Company adjusts ASPs based on anticipated changes in the factors above. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Returns | ||||||||||||||
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. | ||||||||||||||
Administrative Fees and Other Rebates | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Prompt Payment Discounts | ||||||||||||||
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. | ||||||||||||||
The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the years ended December 31, 2013 and 2012: | ||||||||||||||
(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 | ||||||
Inventories | ||||||||||||||
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. | ||||||||||||||
Property and Equipment | ||||||||||||||
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: | ||||||||||||||
Buildings and improvements | 20 - 40 years | |||||||||||||
Machinery, furniture and equipment | 3 - 10 years | |||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Intangible Assets | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Goodwill | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Collaborative Arrangements | ||||||||||||||
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. | ||||||||||||||
Research and Development Expenses | ||||||||||||||
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. | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Income Taxes | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
The Company considers potential tax effects resulting from discontinued operations and records intra-period tax allocations, when those effects are deemed material. | ||||||||||||||
Earnings (Loss) per Share | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Stock Splits and Other Reclassifications | ||||||||||||||
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. | ||||||||||||||
Redeemable Convertible Preferred Stock | ||||||||||||||
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). | ||||||||||||||
Fair Value of Financial Instruments | ||||||||||||||
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: | ||||||||||||||
· 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. | ||||||||||||||
· Level 2—Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. | ||||||||||||||
· 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. | ||||||||||||||
See Note 6 for additional information regarding fair value. | ||||||||||||||
Segment Information | ||||||||||||||
The Company currently operates in a single business segment. | ||||||||||||||
Recent Accounting Pronouncements | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
BUSINESS_COMBINATION
BUSINESS COMBINATION | 12 Months Ended | |||||||
Dec. 31, 2013 | ||||||||
BUSINESS COMBINATION | ' | |||||||
BUSINESS COMBINATION | ' | |||||||
2. BUSINESS COMBINATION | ||||||||
On June 19, 2013, BioSante acquired ANIP in an all-stock, tax-free reorganization. The Company is operating under the leadership of the ANIP management team and the board of directors is comprised of two former directors from BioSante and five former ANIP directors. | ||||||||
BioSante issued to ANIP stockholders shares of BioSante common stock such that the ANIP stockholders owned 57% of the combined company’s shares outstanding, and the former BioSante stockholders owned 43%. In addition, immediately prior to the Merger, BioSante distributed to its then current stockholders contingent value rights (“CVR”) providing payment rights arising from a future sale, transfer, license or similar transaction(s) involving BioSante’s LibiGel ® (female testosterone gel). | ||||||||
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. BioSante, the accounting acquiree, was a publicly-traded pharmaceutical company focused on developing high value, medically-needed products. ANIP entered into the Merger to secure additional capital and gain access to capital market opportunities as a public company. | ||||||||
The results of operations of both companies are included in the Company’s consolidated financial statements for all periods after completion of the Merger. | ||||||||
Transaction Costs | ||||||||
In conjunction with the Merger, the Company incurred approximately $7.1 million in transaction costs, which were expensed in the periods in which they were incurred. Costs incurred through December 31, 2013, include: | ||||||||
Category | (in thousands) | |||||||
Legal fees | $ | 1,227 | ||||||
Accounting fees | 122 | |||||||
Consulting fees | 119 | |||||||
Monitoring and advisory fees | 390 | |||||||
Transaction bonuses | 4,801 | |||||||
Other | 429 | |||||||
Total transaction costs | $ | 7,088 | ||||||
Of the total expenses, $0.9 million was incurred and expensed in the year ended December 31, 2012 as selling, general and administrative expense in the accompanying consolidated statements of operations. The remaining $6.2 million was incurred and expensed in the year ended December 31, 2013, $5.5 million as selling, general and administrative expense $0.3 million as interest expense, and $0.4 million as other expense, in the accompanying consolidated statements of operations. | ||||||||
Purchase Consideration and Net Assets Acquired | ||||||||
The fair value of BioSante’s common stock used in determining the purchase price was $1.22 per share, the closing price on June 19, 2013, which resulted in a total purchase consideration of $29.8 million. The fair value of all additional consideration, including the vested BioSante stock options and CVRs, was immaterial. The following presents the preliminary allocation of the purchase consideration to the assets acquired and liabilities assumed on June 19, 2013: | ||||||||
(in thousands) | ||||||||
Total purchase consideration | $ | 29,795 | ||||||
Assets acquired | ||||||||
Cash and cash equivalents | 18,198 | |||||||
Restricted cash | 2,260 | |||||||
Teva license intangible asset | 10,900 | |||||||
Other tangible assets | 79 | |||||||
Deferred tax assets, net | - | |||||||
Goodwill | 1,838 | |||||||
Total assets | 33,275 | |||||||
Liabilities assumed | ||||||||
Accrued severance | 2,965 | |||||||
Other liabilities | 515 | |||||||
Total liabilities | 3,480 | |||||||
Total net assets acquired | $ | 29,795 | ||||||
Any changes in the estimated fair values of the net assets recorded for this business combination upon the finalization of more detailed analyses of the facts and circumstances that existed at the date of the transaction will change the allocation of the purchase price. Any subsequent changes to the purchase allocation during the measurement period that are material will be adjusted retrospectively. | ||||||||
The Teva license is related to a generic male testosterone gel product and is being amortized on a straight-line basis over its estimated useful life of 11 years. Goodwill, which is not tax deductible since the transaction was structured as a tax-free exchange, is considered an indefinite-lived asset and relates primarily to intangible assets that do not qualify for separate recognition. As a result of purchase accounting related to the Merger, the Company established deferred tax assets of $9.6 million, deferred tax liabilities of $3.9 million, and a valuation allowance of $5.7 million, netting to deferred tax assets of $0. | ||||||||
Former BioSante operations generated $0.5 million of revenue in a non-recurring payment related to the Teva license, and no expense from the acquisition date through December 31, 2013. | ||||||||
Pro Forma Condensed Combined Financial Information (unaudited) | ||||||||
The following unaudited pro forma condensed combined financial information summarizes the results of operations for the periods indicated as if the Merger had been completed as of January 1, 2012. Pro forma information reflects adjustments relating to (i) elimination of the interest on ANIP’s senior and equity-linked securities, (ii) elimination of monitoring and advisory fees payable to two ANIP investors, (iii) elimination of transaction costs, and (iv) amortization of intangibles acquired. The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the Merger had occurred as of January 1, 2012 or that may be obtained in the future. | ||||||||
Year ended December 31, | ||||||||
(in thousands) | 2013 | 2012 | ||||||
Net revenues | $ | 30,228 | $ | 22,671 | ||||
Net income/(loss) | $ | 89 | $ | -27,718 | ||||
INVENTORIES
INVENTORIES | 12 Months Ended | |||||||
Dec. 31, 2013 | ||||||||
INVENTORIES | ' | |||||||
INVENTORIES | ' | |||||||
3. INVENTORIES | ||||||||
Inventories consist of the following as of December 31: | ||||||||
(in thousands) | 2013 | 2012 | ||||||
Raw materials | $ | 1,480 | $ | 975 | ||||
Packaging materials | 766 | 585 | ||||||
Work-in-progress | 162 | 374 | ||||||
Finished goods | 1,152 | 891 | ||||||
3,560 | 2,825 | |||||||
Reserve for excess/obsolete inventories | -42 | -15 | ||||||
Inventories, net | $ | 3,518 | $ | 2,810 | ||||
PROPERTY_PLANT_AND_EQUIPMENT
PROPERTY, PLANT, AND EQUIPMENT | 12 Months Ended | |||||||
Dec. 31, 2013 | ||||||||
Property, Plant and Equipment [Abstract] | ' | |||||||
PROPERTY, PLANT, AND EQUIPMENT | ' | |||||||
4. PROPERTY, PLANT, AND EQUIPMENT | ||||||||
Property, Plant and Equipment consist of the following as of December 31: | ||||||||
(in thousands) | 2013 | 2012 | ||||||
Land | $ | 87 | $ | 87 | ||||
Buildings | 3,682 | 3,682 | ||||||
Machinery, furniture and equipment | 3,736 | 3,565 | ||||||
Construction in progress | 229 | 209 | ||||||
7,734 | 7,543 | |||||||
Less: accumulated depreciation | -3,197 | -2,663 | ||||||
Property, Plant and Equipment, net | $ | 4,537 | $ | 4,880 | ||||
Depreciation expense for the years ended December 31, 2013 and 2012 totaled $534 thousand and $517 thousand, respectively. During the years ended December 31, 2013 and 2012, there was no material interest capitalized into construction in progress. | ||||||||
INTANGIBLE_ASSETS
INTANGIBLE ASSETS | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ' | ||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ' | ||||||||||||||||
5. INTANGIBLE ASSETS | |||||||||||||||||
Goodwill | |||||||||||||||||
As a result of the Merger (Note 2), the Company recorded goodwill of $1.8 million in its one reporting unit. Management assesses the recoverability of the carrying value of goodwill on an annual basis as of October 31 of each year, and whenever events occur or circumstances changes that would, more likely than not, reduce the fair value of the Company’s reporting unit below its carrying value. | |||||||||||||||||
For the goodwill impairment analysis performed at October 31, 2013, management performed a qualitative assessment to determine whether it was more likely than not that the Company’s goodwill asset was impaired in order to determine the necessity of performing a quantitative impairment test, under which management would calculate the asset’s fair value. 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. Based on management’s assessment of the aforementioned factors, it was determined that it was more likely than not that the fair value of the Company’ one reporting unit is greater than its carrying amount as of October 31, 2013, and therefore no quantitative testing for impairment was required. | |||||||||||||||||
In addition to the qualitative impairment analysis performed at October 31, 2013, there were no events or changes in circumstances that could have reduced the fair value of the Company’s reporting unit below its carrying value from October 31, 2013 to December 31, 2013. No impairment loss was recognized during the year ended December 31, 2013. | |||||||||||||||||
Definite-lived Intangible Assets | |||||||||||||||||
The components of net definite-lived intangible assets are as follows: | |||||||||||||||||
December 31, 2013 | December 31, 2012 | ||||||||||||||||
(in thousands) | Gross Carrying | Accumulated | Gross Carrying | Accumulated | Amortization | ||||||||||||
Amount | Amortization | Amount | Amortization | Period | |||||||||||||
Acquired ANDA intangible asset | $ | 60 | $ | -55 | $ | 60 | $ | - | 3 years | ||||||||
Reglan® intangible asset | 100 | -100 | 100 | -75 | 2 years | ||||||||||||
Teva license intangible asset | 10,900 | -496 | - | - | 11 years | ||||||||||||
$ | 11,060 | $ | -651 | $ | 160 | $ | -75 | ||||||||||
The acquired ANDA and Reglan® intangible assets consist of the exclusive rights, including all of the applicable technical data and other relevant information, to produce certain pharmaceutical products which the Company acquired from various companies. The Teva license was acquired as part of the Merger (Note 2). Intangible assets are stated at the lower of cost or fair value, net of amortization using the straight line method over the expected useful lives of the product rights. Amortization expense was $0.6 million and $50 thousand for the years ended December 31, 2013 and 2012, respectively. | |||||||||||||||||
The Company tests for impairment of definite-lived intangible assets when events or circumstances indicate that the carrying value of the assets may not be recoverable. No such triggering events were identified in 2013 and 2012, and therefore no impairment loss was recognized during those periods. | |||||||||||||||||
Expected future amortization expense is as follows for the years ending December 31: | |||||||||||||||||
(in thousands) | |||||||||||||||||
2014 | $ | 996 | |||||||||||||||
2015 | 991 | ||||||||||||||||
2016 | 991 | ||||||||||||||||
2017 | 991 | ||||||||||||||||
2018 | 991 | ||||||||||||||||
2019 and thereafter | 5,449 | ||||||||||||||||
Total | $ | 10,409 | |||||||||||||||
FAIR_VALUE_DISCLOSURES
FAIR VALUE DISCLOSURES | 12 Months Ended | |||||||||||||
Dec. 31, 2013 | ||||||||||||||
FAIR VALUE DISCLOSURES | ' | |||||||||||||
FAIR VALUE DISCLOSURES | ' | |||||||||||||
6. FAIR VALUE DISCLOSURES | ||||||||||||||
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. | ||||||||||||||
Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||||||||||||||
The inputs used in measuring the fair value of cash and cash equivalents are considered to be level 1 in accordance with the three-tier fair value hierarchy. The fair market values are based on period-end statements supplied by the various banks and brokers that held the majority of the Company's funds. The fair value of short-term financial instruments (primarily accounts receivable, prepaid expenses, accounts payable, accrued expenses, borrowings under line of credit, and other current liabilities) approximate their carrying values because of their short-term nature. | ||||||||||||||
The Company’s CVRs (Note 2) are considered to be contingent consideration and are classified as liabilities. As such, the CVRs were recorded as purchase consideration at their estimated fair value, using level 3 inputs, and are marked to market each reporting period until settlement. The fair value of CVRs is estimated using the present value of management’s projection of the expected payments pursuant to the terms of the CVR agreement, which is the primary unobservable input. If management’s projection or expected payments were to increase substantially, the value of the CVRs could increase as a result. The present value of the liability was calculated using a discount rate of 15%. The Company determined that the fair value of the CVRs, and the changes in such fair value, was immaterial as of December 31, 2013 and for the period from the date of the Merger to December 31, 2013. | ||||||||||||||
Prior to the Merger, ANIP’s warrants to purchase common and preferred stock were classified as derivative liabilities and were measured at fair value using level 3 inputs. The fair value of stock purchase warrants was determined using a two-step process which included valuing ANIP's equity using both market and discounted cash flow methods, and then apportioning that value, using an equity allocation model, to each of ANIP's classes of stock. These models require the use of unobservable inputs such as fair value of ANIP's common and preferred stock, expected term, anticipated volatility, future interest and interest rates, expected cash flows and the number of outstanding common and preferred shares as of a future date. The Company determined that the fair value of the derivative liabilities, and the changes in such fair value, was immaterial as of and for the years ended December 31, 2013 and 2012. All such stock purchase warrants expired in connection with the Merger. | ||||||||||||||
The following table presents the Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of December 31, 2013 and 2012, by level within the fair value hierarchy: | ||||||||||||||
(in thousands) | ||||||||||||||
Description | Fair Value at | Level 1 | Level 2 | Level 3 | ||||||||||
December 31, | ||||||||||||||
2013 | ||||||||||||||
Liabilities | ||||||||||||||
CVRs | $ | - | $ | - | $ | - | $ | - | ||||||
Description | Fair Value at | Level 1 | Level 2 | Level 3 | ||||||||||
December 31, | ||||||||||||||
2012 | ||||||||||||||
Liabilities | ||||||||||||||
Warrants | $ | - | $ | - | $ | - | $ | - | ||||||
Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||||||||||||||
The Company has no non-financial assets and liabilities that are measured at fair value on a recurring basis. | ||||||||||||||
Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis | ||||||||||||||
The Company measures its long-lived assets, including property, plant and equipment, intangible assets and goodwill, at fair value on a non-recurring basis. These assets are recognized at fair value when they are deemed to be other-than-temporarily impaired. No such fair value impairment was recognized in the years ended December 31, 2013 and 2012. | ||||||||||||||
DISCONTINUED_OPERATION
DISCONTINUED OPERATION | 12 Months Ended |
Dec. 31, 2013 | |
DISCONTINUED OPERATION | ' |
DISCONTINUED OPERATIONS | ' |
7. DISCONTINUED OPERATION | |
On September 17, 2010, the Company sold its operation in Gulfport, Mississippi to a third-party. The decision to sell the Gulfport operation was based on its historical underperformance and recurring losses and the anticipated need for continued financing from outside sources to maintain ongoing operations. | |
As of December 31, 2013 and 2012, total net liabilities associated with the discontinued operation were $0.2 million and $0.4 million, respectively, and consisted balances due to various vendors of the discontinued operation and other remaining liabilities. These liabilities are included in accrued expenses in the accompanying consolidated balance sheets. | |
The gains on the discontinued operation totaled $195 thousand and $68 thousand, net of $38 thousand and $36 thousand of income tax expense, for the years ended December 31, 2013 and 2012, respectively and have been segregated from continuing operations in the accompanying consolidated statements of operations. During the year ended December 31, 2013, the gain on discontinued operation was the result of finalizing a portion of the remaining liabilities. During the year ended December 31, 2012, the gain on discontinued operation consisted of various vendor settlements. | |
LINE_OF_CREDIT
LINE OF CREDIT | 12 Months Ended |
Dec. 31, 2013 | |
LINE OF CREDIT | ' |
LINE OF CREDIT | ' |
8. LINE OF CREDIT | |
At December 31, 2013, all of the Company’s previous lines of credit either expired or were repaid and terminated, with no amounts outstanding. Prior to June 2012, the Company had borrowings under a line of credit agreement with a commercial lender. Under the terms of a forbearance agreement, amended in October 2011, the Company could borrow an amount equal to the lesser of the borrowing base, as defined, or $3.5 million. Interest accrued at an annual rate of the Base Rate, as defined, plus 6.0%. In addition, a usage fee equal to 0.75% per annum of the unused facility and a management fee equal to $9 thousand per annum were assessed monthly. The line of credit was secured by substantially all of the Company’s assets. The line of credit and amended forbearance agreement expired in June 2012 and all amounts borrowed were repaid in full at that time. | |
In June 2012, the Company entered into a new revolver loan agreement with a commercial bank in the amount of $5.0 million. The revolver loan agreement bore interest daily at the greater of (i) LIBOR plus 5%, or (ii) 6%, and was secured by substantially all of the Company’s assets. In addition, a usage fee equal to 0.375% per annum of the unused facility and a management fee equal to $18 thousand per annum were assessed monthly. Under the agreement, the Company was required to maintain a minimum fixed charge coverage ratio of 1.1 to 1.0, calculated by dividing (a) (i) earnings before interest, taxes, depreciation and amortization (EBITDA) less (ii) unfinanced capital expenditures, by the sum of cash paid for (b) (i) interest and (ii) monitoring and advisory fees (Note 14). Also, the Company was required to generate at least $0.8 million in EBITDA measured on a trailing four-quarter basis. Restrictive covenants applied to, among other things, research and development expenditures, additional liens, mergers or consolidations, and sales of assets. The Company was not in compliance with certain covenants as of December 31, 2012. The Company subsequently obtained a waiver from its lender, the loan covenants were revised, and the revolver loan limit was increased to $6.0 million. | |
Beginning in 2013, the Company was required to maintain a minimum fixed charge coverage ratio of 1.1 to 1.0. Also beginning in 2013, the Company was required to generate at least 0.2 million in EBITDA during the three month period ending March 31, 2013, $0.5 million in EBITDA during the six month period ending June 30, 2013, $0.7 million in EBITDA during the nine month period ending September 30, 2013, and $0.9 million in EBITDA for the year ended December 31, 2013 and for every quarterly period thereafter measured on a trailing four-quarter basis. Restrictive covenants applied to, among other things, additional liens, mergers or consolidations, and sales of assets. In the event of early termination, the Company was required to pay a prepayment fee of $0.2 million if termination occurred in the first year, $0.1 million if termination occurred in the second year, and $60 thousand if termination occurred after the second year but prior to the last day of the term. As of December 31, 2012, $4.1 million was outstanding on the revolver, at an effective interest rate of 6.0%. The revolver loan was repaid in full in June 2013. | |
REDEEMABLE_CONVERTIBLE_PREFERR
REDEEMABLE CONVERTIBLE PREFERRED STOCK | 12 Months Ended | ||||||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||||||
Temporary Equity Disclosure [Abstract] | ' | ||||||||||||||||||||
Temporary Equity | ' | ||||||||||||||||||||
9. REDEEMABLE CONVERTIBLE PREFERRED STOCK | |||||||||||||||||||||
Prior to the Merger (Note 2), ANIP had four issuances of redeemable convertible preferred stock: Series A, B, C and D. The ANIP’s Series A, B, C and D preferred stock was redeemable at the option of the holders, subject to certain additional requirements. 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. All of ANIP’s Series D preferred stock was 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). There was no Series A, B, C, or D redeemable convertible preferred stock outstanding at December 31, 2013. | |||||||||||||||||||||
The following table presents the highlights of each series of redeemable convertible preferred stock as of December 31, 2012: | |||||||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||||||
Series | Shares | Shares | Carrying | Stated Value | Dividend | Accrued | |||||||||||||||
Authorized | Issued and | Value | per share | Accrual per | Dividends | ||||||||||||||||
Outstanding | Annum | ||||||||||||||||||||
A | 108 | 103 | $ | 11,579 | $ | 100 | 10 | % | $ | 2,186 | |||||||||||
B | 119 | 78 | $ | 10,560 | $ | 110 | 10 | % | $ | 1,837 | |||||||||||
C | 38 | 35 | $ | 4,815 | $ | 110 | 12 | % | $ | 994 | |||||||||||
D | 3,400 | 2,375 | $ | 21,797 | $ | 30 | 10 | % | $ | 4,185 | |||||||||||
For all Series of redeemable convertible preferred stock, dividends compounded quarterly and were payable in cash. All accrued dividends were included in Redeemable Convertible Preferred Stock in the accompanying consolidated balance sheets. Each share of preferred stock was initially convertible into one share of common stock of ANIP at the option of the holder. The conversion rate was subject to adjustment upon the occurrence of certain events including the issuance of dividends payable in the form of common stock, a recapitalization, reorganization or other similar change in the outstanding common stock, or upon the occurrence of certain dilutive financings, as defined. | |||||||||||||||||||||
SHAREHOLDERS_EQUITY
SHAREHOLDER'S EQUITY | 12 Months Ended | ||||||||||
Dec. 31, 2013 | |||||||||||
Stockholders Equity Note [Abstract] | ' | ||||||||||
Stockholders Equity Note Disclosure | ' | ||||||||||
10. SHAREHOLDER’S EQUITY | |||||||||||
Authorized shares | |||||||||||
The Company is authorized to issue up to 33.3 million shares of common stock with a par value of $0.0001 per share, 0.8 million shares of class C special stock with a par value of $0.0001 per share, and 1.7 million shares of undesignated preferred stock with a par value of $0.0001 per share at December 31, 2013. | |||||||||||
There were 9.6 million and 4.1 million shares of common stock issued and outstanding as of December 31, 2013 and 2012, respectively. | |||||||||||
There were 11 thousand shares of class C special stock issued and outstanding as of both December 31, 2013 and 2012. Each share of class C special stock entitles its holder to one vote per share. Each share of class C special stock is exchangeable, at the option of the holder, for one share of the Company's common stock, at an exchange price of $90.00 per share, subject to adjustment upon certain capitalization events. Holders of class C special stock are not entitled to receive dividends or to participate in the distribution of the Company's assets upon any liquidation, dissolution or winding-up of the Company. The holders of class C special stock have no cumulative voting, preemptive, subscription, redemption or sinking fund rights. | |||||||||||
There were no shares of undesignated preferred stock outstanding as of December 31, 2013 or 2012. | |||||||||||
Equity Offerings | |||||||||||
In the years leading up to the Merger, BioSante completed several equity offerings. While BioSante’s capital structure remains in place, ANIP’s historical results of operations replace BioSante’s (Note 2). All historical information is provided using share and per shares amounts adjusted for the July 17, 2013 one-for-six reverse split. | |||||||||||
In August 2012, the Company completed a registered direct offering of 393 thousand shares of its common stock and warrants to purchase an aggregate of 197 thousand shares of its common stock at a purchase price of $8.835 per share to one institutional investor for gross proceeds of $3.5 million. The offering resulted in net proceeds to the Company of $3.3 million after deducting placement agent fees and offering expenses. The warrants were exercisable immediately and continue for a period of five years, at an exercise price of $9.00 per share. The number of shares issuable upon exercise of the warrants and the exercise price of the warrants are adjustable in the event of stock splits, combinations and reclassifications, but not in the event of the issuance of additional securities. | |||||||||||
Warrants issued prior to the Merger | |||||||||||
Warrants to purchase an aggregate of 686 thousand shares (as adjusted for the July 17, 2013 one-for-six reverse split) of the Company's common stock were outstanding and exercisable as of December 31, 2013: | |||||||||||
(in thousands, except per share price) | |||||||||||
Number of | |||||||||||
Underlying Shares | Per Share | ||||||||||
Issue Date | Of Common Stock | Exercise Price | Expiration Date | ||||||||
13-Aug-09 | 67 | $ | 90 | 12-Aug-14 | |||||||
13-Aug-09 | 7 | $ | 90 | 9-Jun-14 | |||||||
8-Mar-10 | 145 | $ | 74.88 | 8-Sep-15 | |||||||
8-Mar-10 | 6 | $ | 77.76 | 9-Jun-14 | |||||||
23-Jun-10 | 99 | $ | 88.2 | 23-Jun-15 | |||||||
23-Jun-10 | 6 | $ | 94.68 | 9-Jun-15 | |||||||
30-Dec-10 | 147 | $ | 72 | 30-Dec-15 | |||||||
30-Dec-10 | 9 | $ | 76.5 | 9-Jun-15 | |||||||
8-Mar-11 | 112 | $ | 81 | 8-Mar-14 | |||||||
8-Mar-11 | 7 | $ | 92.88 | 9-Jun-14 | |||||||
20-Aug-12 | 83 | $ | 9 | 16-Aug-17 | |||||||
During 2013, the Company issued no warrants. In December 2013, warrants to purchase an aggregate of 90 thousand shares of common stock were exercised. During 2013, warrants to purchase an aggregate of 13 thousand shares of common stock expired unexercised. All warrants are classified as equity. | |||||||||||
During 2012, the Company issued warrants to purchase an aggregate of 197 thousand shares of the Company's common stock in connection with the August 2012 registered direct offering as described above. During 2012, warrants to purchase an aggregate of 23 thousand shares of common stock were exercised and warrants to purchase an aggregate of 16 thousand shares of the Company's common stock expired unexercised. | |||||||||||
STOCKBASED_COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended | |||||||||||
Dec. 31, 2013 | ||||||||||||
STOCK-BASED COMPENSATION | ' | |||||||||||
STOCK-BASED COMPENSATION | ' | |||||||||||
11. STOCK-BASED COMPENSATION | ||||||||||||
All equity-based service awards are granted under the ANI Pharmaceuticals, Inc. Amended and Restated 2008 Stock Incentive Plan (the “2008 Plan”). As of December 31, 2013, 136 thousand shares of the Company’s common stock remained available for issuance under the 2008 Plan. | ||||||||||||
The Company measures the cost of equity-based service awards based on the grant-date fair value of the award. The cost is recognized over the period during which an employee is required to provide service in exchange for the award or the requisite service period. The Company recognizes stock-based compensation expense ratably over the vesting periods of the awards, adjusted for estimated forfeitures. The non-cash, stock-based compensation cost that was incurred by the Company in connection with the 2008 Plan was $36 thousand and $0 for the years ended December 31, 2013 and 2012, respectively, which was included in sales, general and administrative expense in the accompanying consolidated statements of operations. No income tax benefit was recognized in the Company’s consolidated statements of operations for stock-based compensation arrangements due to the Company’s net loss position. | ||||||||||||
Stock Options | ||||||||||||
Outstanding employee stock options generally vest over a period of three or four years and have 10-year contractual terms. Upon exercise of an option, the Company issues new shares of its common stock. | ||||||||||||
No options were granted by ANIP in 2012. For 2013, the fair value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model, using the following weighted average assumptions: | ||||||||||||
2013 | ||||||||||||
Expected option life (years) | 6.25 | |||||||||||
Risk-free interest rate | 1.72 | % | ||||||||||
Expected stock price volatility | 55 | % | ||||||||||
Dividend yield | — | |||||||||||
The Company uses the simplified method to estimate the life of options. The risk-free interest rate used is the yield on a United States Treasury note as of the grant date with a maturity equal to the estimated life of the option. The Company calculated an estimated volatility rate based on the closing prices of several competitors that manufacture similar products. The Company has not issued a cash dividend in the past nor does it have any current plans to do so in the future; and therefore, an expected dividend yield of zero was used. Forfeitures are estimated at the time of grant and revised through a cumulative catch-up adjustment in the period of change if actual forfeitures differ from those estimates. For stock options granted during the year ended December 31, 2013, the Company has estimated a forfeiture rate of zero. | ||||||||||||
In July 2013, the Company granted 21 thousand options to the non-officer directors under the 2008 Plan. The weighted average fair value of the options at the date of grant for options granted during 2013 was $3.40 per share. BioSante had 99 thousand stock options outstanding at the date of the Merger. These continued as a result of the Merger, as stock options previously issued and still outstanding under BioSante’s Plans became fully-vested on the date of the Merger. | ||||||||||||
On July 12, 2013, the Company’s Board of Directors approved grants of stock options to employees under the 2008 Plan, subject to shareholder approval of an increase in the total shares available for issuance under the 2008 Plan. As of December 31, 2013, the Company had 325 thousand common stock options outstanding pending shareholder approval. Expense related to these stock options will begin to be recognized only upon shareholder approval. | ||||||||||||
A summary of stock option activity under the Plan during the year ended December 31, 2013 and 2012 is presented below: | ||||||||||||
(in thousands, except per share data) | Option | Weighted | Weighted | Aggregate | ||||||||
Shares | Average | Average | Intrinsic | |||||||||
Exercise Price | Remaining Term | Value | ||||||||||
Outstanding December 31, 2011 | 18 | $ | 11 | 6.2 | $ | 0 | ||||||
Granted | - | - | ||||||||||
Exercised | - | - | 0 | |||||||||
Forfeited or expired | -18 | $ | 11 | |||||||||
Outstanding December 31, 2012 | - | - | - | $ | — | |||||||
Exercisable at December 31, 2012 | - | - | - | $ | — | |||||||
Vested or expected to vest at December 31, 2012 | - | - | - | $ | — | |||||||
Net BioSante Stock Options assumed | 99 | $ | 59.59 | |||||||||
Granted | 21 | $ | 6.36 | |||||||||
Exercised | - | - | — | |||||||||
Forfeited or expired | - | - | ||||||||||
Outstanding December 31, 2013 | 120 | $ | 50.35 | 2.4 | $ | 81 | ||||||
Exercisable at December 31, 2013 | 99 | $ | 59.59 | 0.9 | $ | — | ||||||
Vested or expected to vest at December 31, 2013 | 120 | $ | 50.35 | 2.4 | $ | 81 | ||||||
As of December 31, 2013, there was $63 thousand of total unrecognized compensation cost related to non-vested stock options granted under the Plan. The cost is expected to be recognized over a weighted-average period of 3.53 years. | ||||||||||||
Restricted Stock Awards | ||||||||||||
On November 1, 2013, the Company granted 50 thousand restricted stock awards (“RSAs”) to the non-officer directors under the 2008 Plan. No RSAs were granted in the year ended December 31, 2012. The RSAs vest one-third per year, over three years on the anniversary of the grant date, provided that the director continues to serve as a director of the Company on each of the vesting dates. Shares of the Company’s common stock delivered to the directors will be unrestricted upon vesting. During the vesting period, the recipient of the restricted stock has full voting rights as a stockholder and would receive dividends, if declared, even though the restricted stock remains subject to transfer restrictions and will generally be forfeited upon termination of the director from the board prior to vesting. The fair value of each RSA is based on the market value of the Company’s stock on the date of grant. | ||||||||||||
A summary of RSA activity under the Plan during the year ended December 31, 2013 is presented below: | ||||||||||||
(in thousands, except per share | Shares | Weighted | Weighted Average | |||||||||
data) | Average Grant | Remaining Term (years) | ||||||||||
Date Fair Value | ||||||||||||
Unvested at December 31, 2012 | - | $ | - | |||||||||
Granted | 50 | $ | 10.2 | |||||||||
Vested | - | $ | - | |||||||||
Forfeited | - | $ | - | |||||||||
Unvested at December 31, 2013 | 50 | $ | 10.2 | 2.84 | ||||||||
As of December 31, 2013, there was $0.5 million of total unrecognized compensation cost related to non-vested RSAs granted under the Plan, which is expected to be recognized over a weighted-average period of 2.84 years. | ||||||||||||
INCOME_TAXES
INCOME TAXES | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
INCOME TAXES | ' | ||||||||
INCOME TAXES | ' | ||||||||
12. INCOME TAXES | |||||||||
The Company’s total provision (benefit) from income taxes consists of the following for the years ended December 31, 2013 and 2012: | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Current income tax provision (benefit): | |||||||||
Federal | $ | 20 | $ | - | |||||
State | - | - | |||||||
Total | 20 | - | |||||||
Deferred income tax provision (benefit): | |||||||||
Federal | 635 | -1,486 | |||||||
State | -221 | -35 | |||||||
Total | 414 | -1,522 | |||||||
Change in valuation allowance | -414 | 1,522 | |||||||
Tax provision (benefit) from continuing operations | 20 | -36 | |||||||
Tax provision from discontinued operation | 38 | 36 | |||||||
Total provision (benefit) for income taxes | $ | 58 | $ | - | |||||
The difference between the Company's expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax income (loss) from continuing operations and actual income tax provision (benefit) from continuing operations relates primarily to the effect of the following: | |||||||||
As of December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
US Federal statutory rate | 35 | % | -34 | % | |||||
State taxes, net of Federal benefit | 1 | % | -0.9 | % | |||||
Non-deductible expenses | 245.9 | % | 17.7 | % | |||||
Change in valuation allowance | -300.4 | % | 100.7 | % | |||||
Change in tax rates and other | 34.6 | % | -85.7 | % | |||||
Total income tax provision (benefit) | 16.1 | % | -2.2 | % | |||||
Deferred income taxes reflect the net tax effects of differences between the bases of assets and liabilities for financial reporting and income tax purposes. The Company's deferred income tax assets and liabilities consisted of the following: | |||||||||
As of December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Deferred tax assets: | |||||||||
Accruals and advances | $ | 1,160 | $ | 383 | |||||
Net operating loss carryforward | 16,409 | 11,271 | |||||||
Other | 418 | 193 | |||||||
Total deferred tax assets | 17,987 | 11,847 | |||||||
Deferred tax liabilities: | |||||||||
Depreciation | -220 | -236 | |||||||
Intangible assets | -526 | - | |||||||
Other | -374 | -52 | |||||||
Total deferred tax liabilities | -1,120 | -288 | |||||||
Valuation allowance | -16,867 | -11,559 | |||||||
Total deferred tax asset (liability), net | $ | - | $ | - | |||||
As of December 31, 2013, the Company had Federal net operating loss carryforwards of approximately $235.3 million, which expire beginning in 2018, and a portion of which arose as a result of the merger. The utilization of the net operating loss carryforwards may be limited in future years as prescribed by Section 382 of the U.S. Internal Revenue Code, which results in a deferred tax asset related to the net operating loss carryforward after application of the Section 382 limitations of approximately $16.4 million. | |||||||||
The Company is required to establish a valuation allowance for deferred tax assets if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The Company considers the projected future taxable income and tax planning strategies in making this assessment. Based upon the level of historical taxable income and projections for future taxable income in the periods which the deferred tax assets are deductible, the Company has determined that a full valuation allowance is required as of December 31, 2013 and 2012. | |||||||||
The Company is subject to income taxes in numerous jurisdictions in the United States. Significant judgment is required in evaluating the Company’s tax positions and determining its provision for income taxes. The Company establishes liabilities for tax-related uncertainties based on estimates of whether, and the extent to which, additional taxes will be due. These liabilities are established when the Company believes that certain positions might be challenged despite its belief that its tax return positions are fully supportable. The Company adjusts these liabilities in light of changing facts and circumstances, such as the outcome of a tax audit. The provision for income taxes includes the impact of changes to the liability that is considered appropriate. The Company has identified no material uncertain tax positions as of December 31, 2013. | |||||||||
The Company is subject to income tax audits in all jurisdictions for which it files tax returns. Tax audits by their nature are often complex and can require several years to complete. Neither the Company nor any of its subsidiaries is currently under audit in any jurisdiction. All of the Company’s income tax returns remain subject to examination by tax authorities due to the availability of net operating loss carryforwards. | |||||||||
COLLABORATIVE_ARRANGEMENTS
COLLABORATIVE ARRANGEMENTS | 12 Months Ended |
Dec. 31, 2013 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
COLLABORATIVE ARRANGEMENTS | ' |
13. COLLABORATIVE ARRANGEMENTS | |
RiconPharma LLC | |
In July 2011, the Company entered into a collaborative arrangement with RiconPharma LLC (“RiconPharma”). Under the parties' master product development and collaboration agreement (the “RiconPharma Agreement”), the Company and RiconPharma have agreed to collaborate in a cost, asset and profit sharing arrangement for the development, manufacturing, regulatory approval and marketing of pharmaceutical products in the United States. | |
In general, RiconPharma is responsible for developing the products and the Company is responsible for manufacturing, sales, marketing and distribution of the products. The parties are jointly responsible for directing any bioequivalence studies. The Company is responsible for obtaining and maintaining all necessary regulatory approvals, including the preparation of all ANDAs. | |
Under the RiconPharma Agreement and unless otherwise specified in an amendment, the parties will own equally all the rights, title and interest in the products. To the extent permitted by applicable law, the Company will be identified on the product packaging as the manufacturer and distributor of the product. During the term of the agreement, both parties are prohibited from developing, manufacturing, selling or distributing any products that are identical or bioequivalent to products covered under the RiconPharma Agreement. | |
The Company recognizes the costs incurred with respect to this agreement as expense and classifies the expenses based on the nature of the costs. In the year ended December 31, 2013 and 2012, the Company incurred $0.7 million and $0.2 million in research and development expenses related to the RiconPharma Agreement. No revenue has yet been recognized. | |
Sofgen Pharmaceuticals | |
In August 2013, the Company entered into an agreement with Sofgen Pharmaceuticals (“Sofgen”) to develop an oral soft gel prescription product indicated for cardiovascular health (the “Sofgen Agreement”). It will be subject to an ANDA filing once developed. In general, Sofgen will be responsible for the development, manufacturing and regulatory submission of the product, including preparation of the ANDA, with the Company providing payments based on the completion of certain milestones. Upon approval, Sofgen will manufacture the drug and the Company will be responsible for the marketing and distribution, under the ANI label, of the product in the U.S., providing a percentage of profits from sales of the drug to Sofgen. | |
Under the Sofgen Agreement, Sofgen will own all the rights, title and interest in the products. During the term of the Agreement, both parties are prohibited from developing, manufacturing, selling or distributing any product that is identical or bioequivalent to the product covered under the Sofgen Agreement in the U.S. The agreement may be terminated or amended under certain specified circumstances. | |
The Company recognizes the costs incurred with respect to the Sofgen Agreement as expense and classifies the expenses based on the nature of the costs. In the year ended December 31, 2013, the Company incurred $0.2 million in research and development expenses related to the Sofgen Agreement. No revenue has yet been recognized. | |
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
COMMITMENTS AND CONTINGENCIES | ' | ||||
COMMITMENTS AND CONTINGENCIES | ' | ||||
14. COMMITMENTS AND CONTINGENCIES | |||||
Operating Leases | |||||
The Company leases equipment under operating leases that expire in May 2017. The Company also leases office space under operating leases that expire beginning in February 2014 through September 2018. | |||||
For the annual periods after December 31, 2013, approximate minimum annual rental payments under non-cancelable leases are presented below: | |||||
(in thousands) | |||||
Year | Minimum | ||||
Annual Rental | |||||
Payments | |||||
2014 | $ | 148 | |||
2015 | 78 | ||||
2016 | 53 | ||||
2017 | 44 | ||||
2018 | 29 | ||||
Thereafter | - | ||||
Total | $ | 352 | |||
Rent expense for the years ended December 31, 2013 and 2012 totaled $36 thousand and $18 thousand, respectively. | |||||
Monitoring and Advisory Fees | |||||
The Company was required to pay monitoring and advisory fees to two investors. A total of $0.5million and $0.2million are included in other expense in the accompanying consolidated statements of operations for the years ended December 31, 2013 and 2012, respectively. These fees were paid quarterly in advance on the first business day of each calendar quarter. | |||||
Included in the amounts above and in conjunction with the Merger, the Company paid additional monitoring and advisory fees totaling $0.4million to the same two investors (Note 2). Upon completion of the Merger, the Company’s obligation to pay monitoring and advisory fees was terminated. | |||||
Government Regulation | |||||
The Company's products and facilities are subject to regulation by a number of federal and state governmental agencies. The Food and Drug Administration ("FDA"), in particular, maintains oversight of the formulation, manufacture, distribution, packaging and labeling of all of the Company's products. The Drug Enforcement Administration ("DEA") maintains oversight over the Company's products that are considered controlled substances. | |||||
Unapproved Products | |||||
Two of the Company’s products, Esterified Estrogen with Methyltestosterone tablets and Opium Tincture, are marketed without approved New Drug Applications ("NDAs") or Abbreviated New Drug Applications ("ANDAs"). During the years ended December 31, 2013 and 2012, net revenues for these products totaled $14.6 million and $6.0 million, respectively. | |||||
The FDA's policy with respect to the continued marketing of unapproved products is stated in the FDA's September 2011 Compliance Policy Guide Sec. 440.100 titled “Marketed New Drugs without Approved NDAs or ANDAs.” Under this policy, the FDA has stated that it will follow a risk-based approach with regard to enforcement against such unapproved products. The FDA evaluates whether to initiate enforcement action on a case-by-case basis, but gives higher priority to enforcement action against products in certain categories, such as those marketed as unapproved drugs with potential safety risks or that lack evidence of effectiveness. The Company believes that so long as it complies with applicable manufacturing and labeling standards, the FDA will not take action against it under the current enforcement policy. There can be no assurance, however, that the FDA will continue this policy or not take a contrary position with any individual product or group of products. If the FDA were to take a contrary position, the Company may be required to seek FDA approval for these products or withdraw such products from the market. | |||||
In addition, one group of products that the Company manufactures on behalf of a contract customer is marketed by that customer without an FDA-approved NDA. If the FDA took enforcement action against such customer, the customer may be required to seek FDA approval for the group of products or withdraw them from the market. The Company's contract manufacturing revenues for the group of unapproved products for the years ended December 31, 2013 and 2012 was $2.0 million and $1.4 million, respectively. | |||||
The Company received royalties on the net sales of a group of contract-manufactured products, which are marketed by the contract customer without an FDA-approved NDA. If the FDA took enforcement action against such customer, the customer may be required to seek FDA approval for the group of products or withdraw them from the market. The Company's royalties on the net sales of these unapproved products for the years ended December 31, 2013 and 2012 were $330 thousand and $284 thousand, respectively. | |||||
In October 2012, the Company received a telephone call requesting a meeting with the FDA representatives from the Minneapolis district of the FDA to discuss continued manufacturing and distribution of the Opium 10mg/mL Solution 118mL product (“Opium Tincture”), which is a Non-NDA Product. That meeting was held on October 25, 2012 by conference telephone call and included FDA representatives from the Office of Compliance at the Center for Drug Evaluation and Research. Counsel to the Company sent a letter to the FDA on November 9, 2012 in support of the Company’s position. Although the FDA confirmed receipt of this letter, the Company has received no further response thereto. If the FDA were to make a determination that the Company could not continue to sell Opium Tincture as an unapproved product, the Company would be required to seek FDA approval for such product or withdraw such product from the market. If the Company determined to withdraw the product from the market, the Company's net revenues for generic pharmaceutical products would decline materially, and if the Company decided to seek FDA approval, it would face increased expenses and might need to suspend sales of the product until such approval is obtained, and there are no assurances that the Company would receive such approval. | |||||
Shareholder Class Action and Derivative Lawsuits | |||||
On February 3, 2012, a purported class action lawsuit was filed in the United States District Court for the Northern District of Illinois under the caption Thomas Lauria, on behalf of himself and all others similarly situated v. BioSante Pharmaceuticals, Inc. and Stephen M. Simes naming the Company and its former President and Chief Executive Officer, Stephen M. Simes, as defendants. The complaint alleges that certain of the Company’s disclosures relating to the efficacy of LibiGel® and its commercial potential were false and/or misleading and that such false and/or misleading statements had the effect of artificially inflating the price of the Company’s securities resulting in violations of Section 10(b) of the Exchange Act, Rule 10b-5 and Section 20(a) of the Exchange Act. | |||||
Although a substantially similar complaint was filed in the same court on February 21, 2012, such complaint was voluntarily dismissed by the plaintiff in April 2012. The plaintiff sought to represent a class of persons who purchased the Company’s securities between February 12, 2010 and December 15, 2011, and sought unspecified compensatory damages, equitable and/or injunctive relief, and reasonable costs, expert fees and attorneys’ fees on behalf of such purchasers. On November 6, 2012, the plaintiff filed a consolidated amended complaint. On December 28, 2012, the Company and Mr. Simes filed motions to dismiss the consolidated amended complaint. On September 11, 2013, the Illinois district court judge granted defendants’ motions to dismiss, without prejudice, and gave plaintiffs 28 days to file an amended complaint. The plaintiffs did not file an amended complaint and the matter has been concluded. | |||||
On May 7, 2012, Jerome W. Weinstein, a purported stockholder of the Company, filed a shareholder derivative action in the United States District Court for the Northern District of Illinois under the caption Weinstein v. BioSante Pharmaceuticals, Inc. et al., naming the Company’s directors as defendants and the Company as a nominal defendant. A substantially similar complaint was filed in the same court on May 22, 2012 and another substantially similar complaint was filed in the Circuit Court for Cook County, Illinois, County Department, Chancery Division, on June 27, 2012. The suits generally related to the same events that are the subject of the class action litigation described above. The complaints allege breaches of fiduciary duty, abuse of control, gross mismanagement and unjust enrichment as causes of action occurring from at least February 2010 through December 2011. The complaints seek unspecified damages, punitive damages, costs and disbursements and unspecified reform and improvements in the Company’s corporate governance and internal control procedures. | |||||
On September 24, 2012, the United States District Court consolidated the two shareholder derivative cases before it and on November 20, 2012, the plaintiffs filed their consolidated amended complaint. On January 11, 2013, the defendants filed a motion to dismiss the amended complaint. On September 11, 2013, the Illinois district court judge granted defendants’ motions to dismiss, without prejudice, and gave plaintiffs 28 days to file an amended complaint. The plaintiffs did not file an amended complaint and the district court matter has been concluded. | |||||
On November 27, 2012, the plaintiff in the shareholder derivative action pending in Illinois state court filed an amended complaint. On January 18, 2013, the defendants filed a motion to dismiss the amended complaint. On July 1, 2013, the Illinois state court judge granted defendants’ motions to dismiss, without prejudice, and gave plaintiffs until July 31, 2013 to file an amended complaint. On September 9, 2013, the Illinois state court judge granted defendants’ motion to dismiss, with prejudice. On October 9, 2013, the plaintiffs filed a notice of appeal to Illinois state appellate court. The Company believes the state court complaint is without merit and will continue to defend the action vigorously. | |||||
Management is unable to predict the outcome of the remaining lawsuit and the possible loss or range of loss, if any, associated with its resolution or any potential effect the lawsuit may have on the Company’s operations. Depending on the outcome or resolution of the remaining lawsuit, it could have a material effect on the Company’s operations, including its financial condition, results of operations, or cash flows. No amounts have been accrued related to this legal action as of December 31, 2013. | |||||
Louisiana Medicaid Lawsuit | |||||
On September 11, 2013, the Attorney General of the State of Louisiana filed a lawsuit in Louisiana state court against the Company and numerous other pharmaceutical companies, under various state laws, alleging that each defendant caused the state’s Medicaid agency to provide reimbursement for drug products that allegedly were not approved by the FDA and therefore allegedly not reimbursable under the federal Medicaid program. The lawsuit relates to three cough and cold prescription products manufactured and sold by the Company’s former Gulfport, Mississippi operation, which was sold in September 2010. Through its lawsuit, the state seeks unspecified damages, statutory fines, penalties, attorney’s fees and costs. On October 15, 2013, the defendants removed the lawsuit to the U.S. District Court. On November 14, 2013, the state filed a motion to remand the lawsuit to the Louisiana state court. While the Company cannot predict the outcome of the lawsuit at this time, it could be subject to material damages, penalties and fines. The Company intends to vigorously defend against all claims in the lawsuit. | |||||
Other Commitments and Contingencies | |||||
All manufacturers of the drug Reglan ® and its generic equivalent metoclopramide, including the Company, are facing allegations from plaintiffs in various states claiming bodily injuries as a result of ingestion of metoclopramide or its brand name Reglan ® prior to the FDA's February 2009 Black Box warning requirement. The Company has been named and served in 85 separate complaints, including three in Pennsylvania, nine in New Jersey, and 73 in California, covering 2,934 plaintiffs in total. In August 2012, the Company was dismissed with prejudice from all New Jersey cases. Management considers the Company’s exposure to this litigation to be limited due to several factors: (1) the only generic metoclopramide manufactured by the Company prior to the implementation of the FDA's warning requirement was an oral solution introduced after May 28, 2008; (2) the Company’s market share for the oral solution was a very small portion of the overall metoclopramide market; and (3) once the Company received a request for change of labeling from the FDA, it submitted its proposed changes within 30 days, and such changes were subsequently approved by the FDA. At the present time, management is unable to assess the likely outcome of the remaining cases. The Company’s insurance company has assumed the defense of this matter. In addition, the Company’s insurance company renewed the Company’s product liability insurance on September 1, 2012 and 2013 with absolute exclusions for claims related to Reglan® and metoclopramide. Management is unable to predict the outcome of these matters and the possible loss or range of loss, if any, associated with their resolution or any potential effect the legal action may have on the Company’s operations. Furthermore, management cannot provide assurances that the outcome of these matters will not have an adverse effect on its business, results of operations, financial condition, and cash flow. Like all pharmaceutical manufacturers, the Company in the future may be exposed to other product liability claims, which could harm its business, results of operations, financial condition, and cash flows. | |||||
SUBSEQUENT_EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2013 | |
Subsequent Events [Abstract] | ' |
SUBSEQUENT EVENTS | ' |
15. SUBSEQUENT EVENTS | |
Asset Purchase | |
In December 2013, the Company entered into an agreement to purchase Abbreviated New Drug Applications (“ANDAs”) to produce 31 generic drug products from Teva Pharmaceuticals, Inc. (“Teva”) for $12.5 million in cash and a percentage of future gross profits from product sales. According to the terms of the agreement, Teva was required to provide soft copy materials and transfer ownership of the ANDAs to the Company within five business days of signing the agreement, and the Company was required to and did pay the first installment of $8.5 million upon receipt thereof. Teva provided the soft copy materials and transferred ownership of the ANDAs to the Company on January 2, 2014 and the Company paid the first installment of $8.5 million to Teva on January 2, 2014. Teva was also required to provide hard copy materials to the Company within 90 days of signing the asset purchase agreement and the Company will pay the balance upon receipt of hard copy materials. The drug products include 20 solid-oral immediate release products, four extended release products and seven liquid products. Management performed an assessment of the assets purchased and determined that this transaction was an asset purchase and not a business combination. The ANDAs were not recorded as of December 31, 2013, as the exchange did not take place until 2014. The ANDAs will be amortized in full over their useful lives, averaging 10 years. | |
DESCRIPTION_OF_BUSINESS_AND_SU1
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 | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Basis of Presentation | ' | |||||||||||||
Basis of Presentation | ||||||||||||||
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. | ||||||||||||||
Principles of consolidation | ' | |||||||||||||
Principles of Consolidation | ||||||||||||||
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. | ||||||||||||||
Use of Estimates | ' | |||||||||||||
Use of Estimates | ||||||||||||||
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. | ||||||||||||||
Credit Concentration | ' | |||||||||||||
Credit Concentration | ||||||||||||||
The Company's customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and other pharmaceutical companies. | ||||||||||||||
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. | ||||||||||||||
Vendor Concentration | ' | |||||||||||||
Vendor Concentration | ||||||||||||||
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. | ||||||||||||||
Revenue Recognition | ' | |||||||||||||
Revenue Recognition | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Cash and Cash Equivalents | ' | |||||||||||||
Cash and Cash Equivalents | ||||||||||||||
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. | ||||||||||||||
In conjunction with the Merger, the Company acquired restricted cash, none of which remained at December 31, 2013. | ||||||||||||||
Accounts Receivable | ' | |||||||||||||
Accounts Receivable | ||||||||||||||
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. | ||||||||||||||
Accruals for Chargebacks, Returns and Other Allowances | ' | |||||||||||||
Accruals for Chargebacks, Returns and Other Allowances | ||||||||||||||
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. | ||||||||||||||
Chargebacks | ||||||||||||||
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"). | ||||||||||||||
Chargeback credits are calculated as follows: | ||||||||||||||
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: | ||||||||||||||
· | 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 | |||||||||||||
As necessary, the Company adjusts ASPs based on anticipated changes in the factors above. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Returns | ||||||||||||||
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. | ||||||||||||||
Administrative Fees and Other Rebates | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Prompt Payment Discounts | ||||||||||||||
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. | ||||||||||||||
The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the years ended December 31, 2013 and 2012: | ||||||||||||||
(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 | ||||||
Inventories | ' | |||||||||||||
Inventories | ||||||||||||||
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. | ||||||||||||||
Property and Equipment | ' | |||||||||||||
Property and Equipment | ||||||||||||||
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: | ||||||||||||||
Buildings and improvements | 20 - 40 years | |||||||||||||
Machinery, furniture and equipment | 3 - 10 years | |||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Intangible Assets | ' | |||||||||||||
Intangible Assets | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Goodwill | ' | |||||||||||||
Goodwill | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Collaborative Arrangements | ' | |||||||||||||
Collaborative Arrangements | ||||||||||||||
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. | ||||||||||||||
Research and Development Expense | ' | |||||||||||||
Research and Development Expenses | ||||||||||||||
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. | ||||||||||||||
Stock-Based Compensation | ' | |||||||||||||
Stock-Based Compensation | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Income Taxes | ' | |||||||||||||
Income Taxes | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
The Company considers potential tax effects resulting from discontinued operations and records intra-period tax allocations, when those effects are deemed material. | ||||||||||||||
Earnings (Loss) per Share | ' | |||||||||||||
Earnings (Loss) per Share | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
Stock Splits and Other Reclassifications | ' | |||||||||||||
Stock Splits and Other Reclassifications | ||||||||||||||
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. | ||||||||||||||
Redeemable Convertible Preferred Stock | ' | |||||||||||||
Redeemable Convertible Preferred Stock | ||||||||||||||
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). | ||||||||||||||
Fair Value of Financial Instruments | ' | |||||||||||||
Fair Value of Financial Instruments | ||||||||||||||
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: | ||||||||||||||
· 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. | ||||||||||||||
· Level 2—Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. | ||||||||||||||
· 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. | ||||||||||||||
See Note 6 for additional information regarding fair value. | ||||||||||||||
Segment Information | ' | |||||||||||||
Segment Information | ||||||||||||||
The Company currently operates in a single business segment. | ||||||||||||||
Recent Accounting Pronouncements | ' | |||||||||||||
Recent Accounting Pronouncements | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
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. | ||||||||||||||
DESCRIPTION_OF_BUSINESS_AND_SU2
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended | |||||||||||||
Dec. 31, 2013 | ||||||||||||||
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | |||||||||||||
Schedule of Valuation and Qualifying Accounts Disclosure | ' | |||||||||||||
The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the years ended December 31, 2013 and 2012: | ||||||||||||||
(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 | ||||||
BUSINESS_COMBINATION_Tables
BUSINESS COMBINATION (Tables) | 12 Months Ended | |||||||
Dec. 31, 2013 | ||||||||
BUSINESS COMBINATION | ' | |||||||
Business Combination Transaction Costs | ' | |||||||
Costs incurred through December 31, 2013, include: | ||||||||
Category | (in thousands) | |||||||
Legal fees | $ | 1,227 | ||||||
Accounting fees | 122 | |||||||
Consulting fees | 119 | |||||||
Monitoring and advisory fees | 390 | |||||||
Transaction bonuses | 4,801 | |||||||
Other | 429 | |||||||
Total transaction costs | $ | 7,088 | ||||||
Business Combination Purchase Price Allocation | ' | |||||||
The following presents the preliminary allocation of the purchase consideration to the assets acquired and liabilities assumed on June 19, 2013: | ||||||||
(in thousands) | ||||||||
Total purchase consideration | $ | 29,795 | ||||||
Assets acquired | ||||||||
Cash and cash equivalents | 18,198 | |||||||
Restricted cash | 2,260 | |||||||
Teva license intangible asset | 10,900 | |||||||
Other tangible assets | 79 | |||||||
Deferred tax assets, net | - | |||||||
Goodwill | 1,838 | |||||||
Total assets | 33,275 | |||||||
Liabilities assumed | ||||||||
Accrued severance | 2,965 | |||||||
Other liabilities | 515 | |||||||
Total liabilities | 3,480 | |||||||
Total net assets acquired | $ | 29,795 | ||||||
Business Acquisition, Pro Forma Information | ' | |||||||
The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the Merger had occurred as of January 1, 2012 or that may be obtained in the future. | ||||||||
Year ended December 31, | ||||||||
(in thousands) | 2013 | 2012 | ||||||
Net revenues | $ | 30,228 | $ | 22,671 | ||||
Net income/(loss) | $ | 89 | $ | -27,718 | ||||
INVENTORIES_Tables
INVENTORIES (Tables) | 12 Months Ended | |||||||
Dec. 31, 2013 | ||||||||
INVENTORIES | ' | |||||||
Schedule of Inventory, Current | ' | |||||||
Inventories consist of the following as of December 31: | ||||||||
(in thousands) | 2013 | 2012 | ||||||
Raw materials | $ | 1,480 | $ | 975 | ||||
Packaging materials | 766 | 585 | ||||||
Work-in-progress | 162 | 374 | ||||||
Finished goods | 1,152 | 891 | ||||||
3,560 | 2,825 | |||||||
Reserve for excess/obsolete inventories | -42 | -15 | ||||||
Inventories, net | $ | 3,518 | $ | 2,810 | ||||
PROPERTY_PLANT_AND_EQUIPMENT_T
PROPERTY, PLANT, AND EQUIPMENT (Tables) | 12 Months Ended | |||||||
Dec. 31, 2013 | ||||||||
Property, Plant and Equipment [Abstract] | ' | |||||||
Property, Plant and Equipment | ' | |||||||
Property, Plant and Equipment consist of the following as of December 31: | ||||||||
(in thousands) | 2013 | 2012 | ||||||
Land | $ | 87 | $ | 87 | ||||
Buildings | 3,682 | 3,682 | ||||||
Machinery, furniture and equipment | 3,736 | 3,565 | ||||||
Construction in progress | 229 | 209 | ||||||
7,734 | 7,543 | |||||||
Less: accumulated depreciation | -3,197 | -2,663 | ||||||
Property, Plant and Equipment, net | $ | 4,537 | $ | 4,880 | ||||
INTANGIBLE_ASSETS_Tables
INTANGIBLE ASSETS (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ' | ||||||||||||||||
Schedule of Intangible Assets and Goodwill | ' | ||||||||||||||||
The components of net definite-lived intangible assets are as follows: | |||||||||||||||||
December 31, 2013 | December 31, 2012 | ||||||||||||||||
(in thousands) | Gross Carrying | Accumulated | Gross Carrying | Accumulated | Amortization | ||||||||||||
Amount | Amortization | Amount | Amortization | Period | |||||||||||||
Acquired ANDA intangible asset | $ | 60 | $ | -55 | $ | 60 | $ | - | 3 years | ||||||||
Reglan® intangible asset | 100 | -100 | 100 | -75 | 2 years | ||||||||||||
Teva license intangible asset | 10,900 | -496 | - | - | 11 years | ||||||||||||
$ | 11,060 | $ | -651 | $ | 160 | $ | -75 | ||||||||||
Finite-lived Intangible Assets Amortization Expense | ' | ||||||||||||||||
Expected future amortization expense is as follows for the years ending December 31: | |||||||||||||||||
(in thousands) | |||||||||||||||||
2014 | $ | 996 | |||||||||||||||
2015 | 991 | ||||||||||||||||
2016 | 991 | ||||||||||||||||
2017 | 991 | ||||||||||||||||
2018 | 991 | ||||||||||||||||
2019 and thereafter | 5,449 | ||||||||||||||||
Total | $ | 10,409 | |||||||||||||||
FAIR_VALUE_DISCLOSURES_Tables
FAIR VALUE DISCLOSURES (Tables) | 12 Months Ended | |||||||||||||
Dec. 31, 2013 | ||||||||||||||
FAIR VALUE DISCLOSURES | ' | |||||||||||||
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | ' | |||||||||||||
The following table presents the Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of December 31, 2013 and 2012, by level within the fair value hierarchy: | ||||||||||||||
(in thousands) | ||||||||||||||
Description | Fair Value at | Level 1 | Level 2 | Level 3 | ||||||||||
December 31, | ||||||||||||||
2013 | ||||||||||||||
Liabilities | ||||||||||||||
CVRs | $ | - | $ | - | $ | - | $ | - | ||||||
Description | Fair Value at | Level 1 | Level 2 | Level 3 | ||||||||||
December 31, | ||||||||||||||
2012 | ||||||||||||||
Liabilities | ||||||||||||||
Warrants | $ | - | $ | - | $ | - | $ | - | ||||||
REDEEMABLE_CONVERTIBLE_PREFERR1
REDEEMABLE CONVERTIBLE PREFERRED STOCK (Tables) | 12 Months Ended | ||||||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||||||
Temporary Equity Disclosure [Abstract] | ' | ||||||||||||||||||||
Temporary Equity | ' | ||||||||||||||||||||
The following table presents the highlights of each series of redeemable convertible preferred stock as of December 31, 2012: | |||||||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||||||
Series | Shares | Shares | Carrying | Stated Value | Dividend | Accrued | |||||||||||||||
Authorized | Issued and | Value | per share | Accrual per | Dividends | ||||||||||||||||
Outstanding | Annum | ||||||||||||||||||||
A | 108 | 103 | $ | 11,579 | $ | 100 | 10 | % | $ | 2,186 | |||||||||||
B | 119 | 78 | $ | 10,560 | $ | 110 | 10 | % | $ | 1,837 | |||||||||||
C | 38 | 35 | $ | 4,815 | $ | 110 | 12 | % | $ | 994 | |||||||||||
D | 3,400 | 2,375 | $ | 21,797 | $ | 30 | 10 | % | $ | 4,185 | |||||||||||
SHAREHOLDERS_EQUITY_Tables
SHAREHOLDER'S EQUITY (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2013 | |||||||||||
Stockholders Equity Note [Abstract] | ' | ||||||||||
Schedule of Stockholders Equity Note, Warrants or Rights | ' | ||||||||||
Warrants to purchase an aggregate of 686 thousand shares (as adjusted for the July 17, 2013 one-for-six reverse split) of the Company's common stock were outstanding and exercisable as of December 31, 2013: | |||||||||||
(in thousands, except per share price) | |||||||||||
Number of | |||||||||||
Underlying Shares | Per Share | ||||||||||
Issue Date | Of Common Stock | Exercise Price | Expiration Date | ||||||||
13-Aug-09 | 67 | $ | 90 | 12-Aug-14 | |||||||
13-Aug-09 | 7 | $ | 90 | 9-Jun-14 | |||||||
8-Mar-10 | 145 | $ | 74.88 | 8-Sep-15 | |||||||
8-Mar-10 | 6 | $ | 77.76 | 9-Jun-14 | |||||||
23-Jun-10 | 99 | $ | 88.2 | 23-Jun-15 | |||||||
23-Jun-10 | 6 | $ | 94.68 | 9-Jun-15 | |||||||
30-Dec-10 | 147 | $ | 72 | 30-Dec-15 | |||||||
30-Dec-10 | 9 | $ | 76.5 | 9-Jun-15 | |||||||
8-Mar-11 | 112 | $ | 81 | 8-Mar-14 | |||||||
8-Mar-11 | 7 | $ | 92.88 | 9-Jun-14 | |||||||
20-Aug-12 | 83 | $ | 9 | 16-Aug-17 | |||||||
STOCKBASED_COMPENSATION_Tables
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended | |||||||||||
Dec. 31, 2013 | ||||||||||||
STOCK-BASED COMPENSATION | ' | |||||||||||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | ' | |||||||||||
2013 | ||||||||||||
Expected option life (years) | 6.25 | |||||||||||
Risk-free interest rate | 1.72 | % | ||||||||||
Expected stock price volatility | 55 | % | ||||||||||
Dividend yield | — | |||||||||||
Schedule of Share-based Compensation, Stock Options, Activity | ' | |||||||||||
(in thousands, except per share data) | Option | Weighted | Weighted | Aggregate | ||||||||
Shares | Average | Average | Intrinsic | |||||||||
Exercise Price | Remaining Term | Value | ||||||||||
Outstanding December 31, 2011 | 18 | $ | 11 | 6.2 | $ | 0 | ||||||
Granted | - | - | ||||||||||
Exercised | - | - | 0 | |||||||||
Forfeited or expired | -18 | $ | 11 | |||||||||
Outstanding December 31, 2012 | - | - | - | $ | — | |||||||
Exercisable at December 31, 2012 | - | - | - | $ | — | |||||||
Vested or expected to vest at December 31, 2012 | - | - | - | $ | — | |||||||
Net BioSante Stock Options assumed | 99 | $ | 59.59 | |||||||||
Granted | 21 | $ | 6.36 | |||||||||
Exercised | - | - | — | |||||||||
Forfeited or expired | - | - | ||||||||||
Outstanding December 31, 2013 | 120 | $ | 50.35 | 2.4 | $ | 81 | ||||||
Exercisable at December 31, 2013 | 99 | $ | 59.59 | 0.9 | $ | — | ||||||
Vested or expected to vest at December 31, 2013 | 120 | $ | 50.35 | 2.4 | $ | 81 | ||||||
Schedule of Unvested Restricted Stock Units Roll Forward | ' | |||||||||||
A summary of RSA activity under the Plan during the year ended December 31, 2013 is presented below: | ||||||||||||
(in thousands, except per share | Shares | Weighted | Weighted Average | |||||||||
data) | Average Grant | Remaining Term (years) | ||||||||||
Date Fair Value | ||||||||||||
Unvested at December 31, 2012 | - | $ | - | |||||||||
Granted | 50 | $ | 10.2 | |||||||||
Vested | - | $ | - | |||||||||
Forfeited | - | $ | - | |||||||||
Unvested at December 31, 2013 | 50 | $ | 10.2 | 2.84 | ||||||||
INCOME_TAXES_Tables
INCOME TAXES (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
INCOME TAXES | ' | ||||||||
Schedule of Components of Income Tax Expense (Benefit) | ' | ||||||||
The Company’s total provision (benefit) from income taxes consists of the following for the years ended December 31, 2013 and 2012: | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Current income tax provision (benefit): | |||||||||
Federal | $ | 20 | $ | - | |||||
State | - | - | |||||||
Total | 20 | - | |||||||
Deferred income tax provision (benefit): | |||||||||
Federal | 635 | -1,486 | |||||||
State | -221 | -35 | |||||||
Total | 414 | -1,522 | |||||||
Change in valuation allowance | -414 | 1,522 | |||||||
Tax provision (benefit) from continuing operations | 20 | -36 | |||||||
Tax provision from discontinued operation | 38 | 36 | |||||||
Total provision (benefit) for income taxes | $ | 58 | $ | - | |||||
Schedule of Effective Income Tax Rate Reconciliation | ' | ||||||||
As of December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
US Federal statutory rate | 35 | % | -34 | % | |||||
State taxes, net of Federal benefit | 1 | % | -0.9 | % | |||||
Non-deductible expenses | 245.9 | % | 17.7 | % | |||||
Change in valuation allowance | -300.4 | % | 100.7 | % | |||||
Change in tax rates and other | 34.6 | % | -85.7 | % | |||||
Total income tax provision (benefit) | 16.1 | % | -2.2 | % | |||||
Schedule of Deferred Tax Assets and Liabilities | ' | ||||||||
The Company's deferred income tax assets and liabilities consisted of the following: | |||||||||
As of December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Deferred tax assets: | |||||||||
Accruals and advances | $ | 1,160 | $ | 383 | |||||
Net operating loss carryforward | 16,409 | 11,271 | |||||||
Other | 418 | 193 | |||||||
Total deferred tax assets | 17,987 | 11,847 | |||||||
Deferred tax liabilities: | |||||||||
Depreciation | -220 | -236 | |||||||
Intangible assets | -526 | - | |||||||
Other | -374 | -52 | |||||||
Total deferred tax liabilities | -1,120 | -288 | |||||||
Valuation allowance | -16,867 | -11,559 | |||||||
Total deferred tax asset (liability), net | $ | - | $ | - | |||||
COMMITMENTS_AND_CONTINGENCIES_
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
COMMITMENTS AND CONTINGENCIES | ' | ||||
Contractual Obligation, Fiscal Year Maturity Schedule | ' | ||||
For the annual periods after December 31, 2013, approximate minimum annual rental payments under non-cancelable leases are presented below: | |||||
(in thousands) | |||||
Year | Minimum | ||||
Annual Rental | |||||
Payments | |||||
2014 | $ | 148 | |||
2015 | 78 | ||||
2016 | 53 | ||||
2017 | 44 | ||||
2018 | 29 | ||||
Thereafter | - | ||||
Total | $ | 352 | |||
DESCRIPTION_OF_BUSINESS_AND_SU3
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Valuation and Qualifying Accounts Disclosure | ' | ' |
Balance, Ending balance | $5,104 | $6,124 |
Chargebacks | ' | ' |
Valuation and Qualifying Accounts Disclosure | ' | ' |
Balance, Beginning balance | 5,662 | 3,681 |
Accruals/adjustments | 28,009 | 22,912 |
Credits taken against reserve | -29,595 | -20,931 |
Balance, Ending balance | 4,076 | 5,662 |
Returns | ' | ' |
Valuation and Qualifying Accounts Disclosure | ' | ' |
Balance, Beginning balance | 411 | 252 |
Accruals/adjustments | 1,595 | 698 |
Credits taken against reserve | -1,270 | -539 |
Balance, Ending balance | 736 | 411 |
Administrative Fees And Other Rebates | ' | ' |
Valuation and Qualifying Accounts Disclosure | ' | ' |
Balance, Beginning balance | 231 | 238 |
Accruals/adjustments | 2,355 | 1,369 |
Credits taken against reserve | -1,851 | -1,376 |
Balance, Ending balance | 735 | 231 |
Prompt Payment Discounts | ' | ' |
Valuation and Qualifying Accounts Disclosure | ' | ' |
Balance, Beginning balance | 242 | 166 |
Accruals/adjustments | 1,129 | 775 |
Credits taken against reserve | -1,039 | -699 |
Balance, Ending balance | $332 | $242 |
DESCRIPTION_OF_BUSINESS_AND_SU4
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2) (USD $) | 12 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,700,000 | 2,700,000 | ' |
Stockholders Equity, Reverse Stock Split | 'one-for-six | ' | ' |
FDIC Guaranteed Amount | $250,000 | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance | 120,000 | 0 | 18,000 |
Research and Development Expense, Total | 1,712,000 | 1,158,000 | ' |
Revenues, Total | 30,082,000 | 20,371,000 | ' |
Class Of Warrant Or Right Outstanding Ending Balance | 686,000 | ' | ' |
Charge backs And Other Accruals As Percent Of Gross Revenue | 60.00% | ' | ' |
Contract Services [Member] | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Revenues, Total | $1,400,000 | $800,000 | ' |
Employee Stock Option [Member] | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance | 120,000 | ' | ' |
Restricted Stock [Member] | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Nonvested Number | 50,000 | ' | ' |
Three Suppliers 2012 [Member] | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Concentration Risk, Percentage | ' | 63.00% | ' |
Three Suppliers 2013 [Member] | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Concentration Risk, Percentage | 37.00% | ' | ' |
Maximum | Finite-Lived Intangible Assets [Member] | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | '11 years | ' | ' |
Maximum | Building and Building Improvements | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Property, Plant and Equipment, Useful Life | '40 years | ' | ' |
Maximum | Machinery, Furniture And Equipment | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Property, Plant and Equipment, Useful Life | '10 years | ' | ' |
Minimum | Finite-Lived Intangible Assets [Member] | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | '2 years | ' | ' |
Minimum | Building and Building Improvements | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Property, Plant and Equipment, Useful Life | '20 years | ' | ' |
Minimum | Machinery, Furniture And Equipment | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Property, Plant and Equipment, Useful Life | '3 years | ' | ' |
Three Customers [Member] | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Concentration Risk, Percentage | 68.00% | ' | ' |
Customer One | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Concentration Risk, Percentage | 27.00% | 25.00% | ' |
Customer Two | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Concentration Risk, Percentage | 18.00% | 21.00% | ' |
Customer Three | ' | ' | ' |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ' | ' |
Concentration Risk, Percentage | 10.00% | 11.00% | ' |
BUSINESS_COMBINATION_Details
BUSINESS COMBINATION (Details) (USD $) | Dec. 31, 2013 |
In Thousands, unless otherwise specified | |
Legal fees | $1,227 |
Accounting fees | 122 |
Consulting fees | 119 |
Monitoring and advisory fees | 390 |
Transaction bonuses | 4,801 |
Other | 429 |
Total transaction costs | $7,088 |
BUSINESS_COMBINATION_Details_2
BUSINESS COMBINATION (Details 2) (USD $) | Dec. 31, 2013 | Jun. 19, 2013 |
In Thousands, unless otherwise specified | ||
Total purchase consideration | $29,800 | $29,795 |
Assets acquired | ' | ' |
Cash and cash equivalents | ' | 18,198 |
Restricted cash | ' | 2,260 |
Teva license intangible asset | ' | 10,900 |
Other tangible assets | ' | 79 |
Deferred tax assets, net | 0 | 0 |
Goodwill | ' | 1,838 |
Total assets | ' | 33,275 |
Liabilities assumed | ' | ' |
Accrued severance | ' | 2,965 |
Other liabilities | ' | 515 |
Total liabilities | ' | 3,480 |
Total net assets acquired | $29,800 | $29,795 |
BUSINESS_COMBINATION_Details_3
BUSINESS COMBINATION (Details 3) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Net revenues | $30,228 | $22,671 |
Net income/(loss) | $89 | ($27,718) |
BUSINESS_COMBINATION_Details_4
BUSINESS COMBINATION (Details 4) (USD $) | 12 Months Ended | 24 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Jun. 19, 2013 | |
Share Price | ' | ' | ' | $1.22 |
Revenues, Total | $30,082,000 | $20,371,000 | ' | ' |
Business Combination Cost Of Acquired Entity Purchase Price | 29,800,000 | ' | 29,800,000 | 29,795,000 |
Business Combination Deferred Tax Assets Established Gross | 9,600,000 | ' | 9,600,000 | ' |
Business Combination Deferred Tax Liabilities Established Gross | 3,900,000 | ' | 3,900,000 | ' |
Valuation allowance | 5,700,000 | ' | 5,700,000 | ' |
Business Combination Purchase Price Allocation Deferred Tax Assets, Net | 0 | ' | 0 | 0 |
Business Combination, Acquisition Related Costs | 6,200,000 | 900,000 | 7,100,000 | ' |
Selling, General and Administrative Expenses [Member] | ' | ' | ' | ' |
Business Combination, Acquisition Related Costs | 5,500,000 | ' | ' | ' |
Interest Expense [Member] | ' | ' | ' | ' |
Business Combination, Acquisition Related Costs | 300,000 | ' | ' | ' |
Other Expense [Member] | ' | ' | ' | ' |
Business Combination, Acquisition Related Costs | 400,000 | ' | ' | ' |
Teva License Intangible Asset [Member] | ' | ' | ' | ' |
Finite-Lived Intangible Asset, Useful Life | '11 years | ' | ' | ' |
BioSante Pharmaceuticals Inc [Member] | ' | ' | ' | ' |
Business Acquisition, Percentage of Voting Interests Acquired | ' | ' | ' | 43.00% |
Revenues, Total | $500 | ' | ' | ' |
ANIP Acquisition Company [Member] | ' | ' | ' | ' |
Business Acquisition, Percentage of Voting Interests Acquired | ' | ' | ' | 57.00% |
INVENTORIES_Details
INVENTORIES (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Inventories | ' | ' |
Raw materials | $1,480 | $975 |
Packaging materials | 766 | 585 |
Work-in-progress | 162 | 374 |
Finished goods | 1,152 | 891 |
Inventory, Gross, Total | 3,560 | 2,825 |
Reserve for excess/obsolete inventories | -42 | -15 |
Inventories, net | $3,518 | $2,810 |
PROPERTY_PLANT_AND_EQUIPMENT_D
PROPERTY, PLANT, AND EQUIPMENT (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment, Gross, Total | $7,734 | $7,543 |
Less: accumulated depreciation | -3,197 | -2,663 |
Property, Plant and Equipment, net | 4,537 | 4,880 |
Land [Member] | ' | ' |
Property, Plant and Equipment, Gross, Total | 87 | 87 |
Building [Member] | ' | ' |
Property, Plant and Equipment, Gross, Total | 3,682 | 3,682 |
Machinery and Equipment [Member] | ' | ' |
Property, Plant and Equipment, Gross, Total | 3,736 | 3,565 |
Construction in Progress [Member] | ' | ' |
Property, Plant and Equipment, Gross, Total | $229 | $209 |
PROPERTY_PLANT_AND_EQUIPMENT_D1
PROPERTY, PLANT, AND EQUIPMENT (Details 2) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Depreciation, Total | $534 | $517 |
INTANGIBLE_ASSETS_Details
INTANGIBLE ASSETS (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
Finite-Lived Intangible Assets, Gross | $11,060 | $160 |
Finite-Lived Intangible Assets, Accumulated Amortization | -651 | -75 |
Acquired ANDA Intangible Asset | ' | ' |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
Finite-Lived Intangible Assets, Gross | 60 | 60 |
Finite-Lived Intangible Assets, Accumulated Amortization | -55 | 0 |
Amortization period | '3 years | ' |
Reglan Intangible Asset | ' | ' |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
Finite-Lived Intangible Assets, Gross | 100 | 100 |
Finite-Lived Intangible Assets, Accumulated Amortization | -100 | -75 |
Amortization period | '2 years | ' |
Teva License Intangible Asset | ' | ' |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
Finite-Lived Intangible Assets, Gross | 10,900 | 0 |
Finite-Lived Intangible Assets, Accumulated Amortization | ($496) | $0 |
Amortization period | '11 years | ' |
INTANGIBLE_ASSETS_Details_2
INTANGIBLE ASSETS (Details 2) (USD $) | Dec. 31, 2013 |
In Thousands, unless otherwise specified | |
GOODWILL AND INTANGIBLE ASSETS | ' |
2014 | $996 |
2015 | 991 |
2016 | 991 |
2017 | 991 |
2018 | 991 |
2019 and thereafter | 5,449 |
Total | $10,409 |
INTANGIBLE_ASSETS_Details_3
INTANGIBLE ASSETS (Details 3) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
Amortization of Intangible Assets | $600,000 | $50,000 |
Goodwill, Acquired During Period | $1,800,000 | ' |
FAIR_VALUE_DISCLOSURES_Details
FAIR VALUE DISCLOSURES (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Liabilities | ' | ' |
CVRs | $0 | ' |
Warrants | ' | 0 |
Fair Value, Inputs, Level 1 [Member] | ' | ' |
Liabilities | ' | ' |
CVRs | 0 | ' |
Warrants | ' | 0 |
Fair Value, Inputs, Level 2 [Member] | ' | ' |
Liabilities | ' | ' |
CVRs | 0 | ' |
Warrants | ' | 0 |
Fair Value, Inputs, Level 3 [Member] | ' | ' |
Liabilities | ' | ' |
CVRs | 0 | ' |
Warrants | ' | $0 |
FAIR_VALUE_DISCLOSURES_Details1
FAIR VALUE DISCLOSURES (Details 2) | 12 Months Ended |
Dec. 31, 2013 | |
Fair Value Inputs, Assets, Quantitative Information | ' |
Fair Value Inputs, Discount Rate | 15.00% |
DISCONTINUED_OPERATION_Details
DISCONTINUED OPERATION (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
DISCONTINUED OPERATION | ' | ' |
Liabilities of Disposal Group, Including Discontinued Operation | $200,000 | $400,000 |
Discontinued Operation, Gain (Loss) on Disposal of Discontinued Operation, Net of Tax, Total | 195,000 | 68,000 |
Discontinued Operation, Tax Effect of Income (Loss) from Disposal of Discontinued Operation | $38,000 | $36,000 |
LINE_OF_CREDIT_Details
LINE OF CREDIT (Details) (USD $) | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2012 | Oct. 31, 2011 | Dec. 31, 2013 | Dec. 31, 2012 | |
Line of Credit Facility | ' | ' | ' | ' |
Line of Credit Facility, Maximum Borrowing Capacity | $5,000,000 | $3,500,000 | ' | $6,000,000 |
Line of Credit Facility, Interest Rate Description | 'The revolver loan agreement bore interest daily at the greater of (i) LIBOR plus 5%, or (ii) 6%, and was secured by substantially all of the Companys assets. | 'Base Rate, as defined, plus 6.0% | ' | ' |
Line of Credit Facility, Unused Capacity, Commitment Fee Percentage | 0.38% | 0.75% | ' | ' |
Line Of Credit Facility Management Fee | 18,000 | 9,000 | ' | ' |
Line of Credit Facility, Covenant Terms | ' | ' | 'Beginning in 2013, the Company was required to maintain a minimum fixed charge coverage ratio of 1.1 to 1.0. Also beginning in 2013, the Company was required to generate at least 0.2 million in EBITDA during the three month period ending March 31, 2013, $0.5 million in EBITDA during the six month period ending June 30, 2013, $0.7 million in EBITDA during the nine month period ending September 30, 2013, and $0.9 million in EBITDA for the year ended December 31, 2013 and for every quarterly period thereafter measured on a trailing four-quarter basis. Restrictive covenants applied to, among other things, additional liens, mergers or consolidations, and sales of assets. | 'Under the agreement, the Company was required to maintain a minimum fixed charge coverage ratio of 1.1 to 1.0, calculated by dividing (a) (i) earnings before interest, taxes, depreciation and amortization (EBITDA) less (ii) unfinanced capital expenditures, by the sum of cash paid for (b) (i) interest and (ii) monitoring and advisory fees (Note 14). Also, the Company was required to generate at least $0.8 million in EBITDA measured on a trailing four-quarter basis. Restrictive covenants applied to, among other things, research and development expenditures, additional liens, mergers or consolidations, and sales of assets. |
Line Of Credit Facility, Termination Fee In First Year | ' | ' | 200,000 | ' |
Line Of Credit Facility, Termination Fee In Second Year | ' | ' | 100,000 | ' |
Line Of Credit Facility, Termination Fee After Second Year | ' | ' | 60,000 | ' |
Line of Credit Facility, Amount Outstanding | ' | ' | $0 | $4,065,000 |
Line of Credit Facility, Interest Rate at Period End | ' | ' | ' | 6.00% |
REDEEMABLE_CONVERTIBLE_PREFERR2
REDEEMABLE CONVERTIBLE PREFERRED STOCK (Details) (USD $) | Dec. 31, 2012 |
In Thousands, except Per Share data, unless otherwise specified | |
Series A | ' |
Shares Authorized | 108 |
Shares Issued | 103 |
Shares Outstanding | 103 |
Carrying Value | $11,579 |
Stated Value Per Share | $100 |
Dividend Accrual Per Annum | 10.00% |
Accrued dividends | 2,186 |
Series B | ' |
Shares Authorized | 119 |
Shares Issued | 78 |
Shares Outstanding | 78 |
Carrying Value | 10,560 |
Stated Value Per Share | $110 |
Dividend Accrual Per Annum | 10.00% |
Accrued dividends | 1,837 |
Series C | ' |
Shares Authorized | 38 |
Shares Issued | 35 |
Shares Outstanding | 35 |
Carrying Value | 4,815 |
Stated Value Per Share | $110 |
Dividend Accrual Per Annum | 12.00% |
Accrued dividends | 994 |
Series D | ' |
Shares Authorized | 3,400 |
Shares Issued | 2,375 |
Shares Outstanding | 2,375 |
Carrying Value | 21,797 |
Stated Value Per Share | $30 |
Dividend Accrual Per Annum | 10.00% |
Accrued dividends | $4,185 |
SHAREHOLDERS_EQUITY_Details
SHAREHOLDER'S EQUITY (Details) (Common Stock [Member]) | Aug. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | Class Of Warrant Issued On 13 August 2009 Expires 12 August 2014 [Member] | Class Of Warrant Issued On 13 August 2009 Expires 09 June 2014 [Member] | Class Of Warrant Issued On 08 March 2010 Expires 08 September 2015 [Member] | Class Of Warrant Issued On 08 March 2010 Expires 09 June 2014 [Member] | Class Of Warrant Issued On 23 June 2010 Expires 23 June 2015 [Member] | Class Of Warrant Issued On 23 June 2010 Expires 09 June 2015 [Member] | Class Of Warrant Issued On 30 December 2010 Expires 30 December 2015 [Member] | Class Of Warrant Issued On 30 December 2010 Expires 09 June 2015 [Member] | Class Of Warrant Issued On 08 March 2011 Expires 08 March 2014 [Member] | Class Of Warrant Issued On 08 March 2011 Expires 09 June 2014 [Member] | Class Of Warrant Issued On 20 August 2012 Expires 16 August 2017 [Member] | |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | ' | 67 | 7 | 145 | 6 | 99 | 6 | 147 | 9 | 112 | 7 | 83 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | 9 | 90 | 90 | 74.88 | 77.76 | 88.2 | 94.68 | 72 | 76.5 | 81 | 92.88 | 9 |
SHAREHOLDERS_EQUITY_Details_2
SHAREHOLDER'S EQUITY (Details 2) (USD $) | 1 Months Ended | 12 Months Ended | 1 Months Ended | ||||||||||
In Millions, except Share data, unless otherwise specified | Aug. 31, 2012 | Dec. 31, 2013 | Jun. 19, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Aug. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 |
Warrant [Member] | Warrant [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Class C Special Stock [Member] | Class C Special Stock [Member] | Undesignated Preferred Stock [Member] | Undesignated Preferred Stock [Member] | |||||
Common Stock, Shares Authorized | ' | ' | ' | ' | ' | ' | ' | 33,300,000 | ' | 781,281 | 781,281 | ' | ' |
Common Stock, Par or Stated Value Per Share | ' | ' | ' | ' | ' | ' | ' | $0.00 | ' | $0.00 | $0.00 | ' | ' |
Common Stock, Shares, Issued | ' | ' | ' | ' | ' | ' | ' | 9,600,000 | 4,100,000 | 10,868 | 10,868 | ' | ' |
Preferred Stock, Shares Authorized | ' | 1,666,667 | ' | 1,666,667 | ' | ' | ' | ' | ' | ' | ' | 1,700,000 | ' |
Common Stock, Shares, Outstanding | ' | ' | ' | ' | ' | ' | ' | 9,600,000 | 4,100,000 | 10,868 | 10,868 | ' | ' |
Common Stock Conversion Price | ' | ' | ' | ' | ' | ' | ' | ' | ' | $90 | $90 | ' | ' |
Preferred Stock, Par or Stated Value Per Share | ' | $0.00 | ' | $0.00 | ' | ' | ' | ' | ' | ' | ' | $0.00 | ' |
Preferred Stock, Shares Outstanding | ' | 0 | ' | 0 | ' | ' | ' | ' | ' | ' | ' | 0 | 0 |
Share Price | ' | ' | $1.22 | ' | ' | ' | $8.84 | ' | ' | ' | ' | ' | ' |
Proceeds From Issuance Of Common Stock And Warrants Gross | ' | ' | ' | ' | ' | ' | $3.50 | ' | ' | ' | ' | ' | ' |
Proceeds From Issuance Of Common Stock And Warrants Net | ' | ' | ' | ' | ' | ' | $3.30 | ' | ' | ' | ' | ' | ' |
Class of Warrant or Right, Exercise Price of Warrants or Rights | ' | ' | ' | ' | ' | ' | 9 | ' | ' | ' | ' | ' | ' |
Class of Warrant or Right, Outstanding | ' | 686,000 | ' | ' | 686,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Stock Issued During Period Due To Warrant Exercise Number | ' | ' | ' | ' | 90,000 | 23,000 | ' | ' | ' | ' | ' | ' | ' |
Class Of Warrant Or Right Number Of Securities Called By Warrants That Expired During Period Number | ' | ' | ' | ' | 13,000 | 16,000 | ' | ' | ' | ' | ' | ' | ' |
Number Of Institutional Investors To Whom Offering Made | 1 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Class Of Warrant Or Right Expiration Period | '5 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock Issued During Period, Shares, New Issues | ' | ' | ' | ' | ' | ' | 393,000 | ' | ' | ' | ' | ' | ' |
Preferred Stock, Shares Issued | ' | 0 | ' | 0 | ' | ' | ' | ' | ' | ' | ' | 0 | 0 |
STOCKBASED_COMPENSATION_Detail
STOCK-BASED COMPENSATION (Details) | 12 Months Ended |
Dec. 31, 2013 | |
Expected option life (years) | '6 years 3 months |
Risk-free interest rate | 1.72% |
Expected stock price volatility | 55.00% |
Dividend yield | 0.00% |
STOCKBASED_COMPENSATION_Detail1
STOCK-BASED COMPENSATION (Details 2) (USD $) | 12 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Option Shares | ' | ' | ' |
Outstanding at the beginning of the period (in shares) | 0 | 18 | ' |
Granted (in shares) | 21 | 0 | ' |
Exercised (in shares) | 0 | 0 | ' |
Forfeited or expired (in shares) | 0 | -18 | ' |
Outstanding at the end of the period (in shares) | 120 | 0 | 18 |
Exercisable at the end of the period (in shares) | 99 | 0 | ' |
Vested or expected to vest at the end of the period (in shares) | 120 | 0 | ' |
Net BioSante Stock Options assumed (in shares) | 99 | ' | ' |
Weighted Average Exercise Price | ' | ' | ' |
Outstanding at the beginning of the period (in dollars per share) | $0 | $11 | ' |
Granted (in dollars per share) | $6.36 | $0 | ' |
Exercised (in dollars per share) | $0 | $0 | ' |
Forfeited or expired (in dollars per share) | $0 | $11 | ' |
Outstanding at the end of the period (in dollars per share) | $50.35 | $0 | $11 |
Exercisable at the end of the period (in dollars per share) | $59.59 | $0 | ' |
Vested or expected to vest at the end of the period (in dollars per share) | $50.35 | $0 | ' |
Net BioSante Stock Options assumed (in dollars per share) | $59.59 | ' | ' |
Weighted Average Remaining Term | ' | ' | ' |
Outstanding at the end of the period weighted average remaining term | '2 years 4 months 24 days | ' | '6 years 2 months 12 days |
Exercisable at the end of the period weighted average remaining term | '10 months 24 days | '0 years | ' |
Vested or expected to vest at the end of the period weighted average remaining term | '2 years 4 months 24 days | '0 years | ' |
Aggregate Intrinsic Value | ' | ' | ' |
Exercised at the end of the period intrinsic value (in dollars) | $0 | $0 | ' |
Outstanding at the end of the period intrinsic value (in dollars) | 81 | 0 | ' |
Exercisable at the end of the period intrinsic value (in dollars) | 0 | 0 | ' |
Vested or expected to vest at the end of the period intrinsic value (in dollars) | $81 | $0 | ' |
STOCKBASED_COMPENSATION_Detail2
STOCK-BASED COMPENSATION (Details 3) (Restricted Stock Awards [Member], USD $) | 12 Months Ended |
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2013 |
Restricted Stock Awards [Member] | ' |
Restricted Stock Outstanding, Beginning of period | 0 |
Granted (in shares) | 50 |
Vested (in shares) | 0 |
Forfeited (in shares) | 0 |
Restricted Stock Outstanding, End of period | 50 |
Restricted Stock Outstanding, Weighted Average Grant Date Fair Value, Beginning of period | $0 |
Granted - Weighted Average GrantDate FairValue | $10.20 |
Vested - Weighted Average GrantDate FairValue | $0 |
Forfeited - Weighted Average GrantDate FairValue | $0 |
Restricted Stock Outstanding, Weighted Average Grant Date Fair Value, End of period | $10.20 |
Unvested - Weighted Average Remaining Term | '2 years 10 months 2 days |
STOCKBASED_COMPENSATION_Detail3
STOCK-BASED COMPENSATION (Details 4) (USD $) | 12 Months Ended | 1 Months Ended | 1 Months Ended | |||||||
Share data in Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Jul. 31, 2013 | Dec. 31, 2013 | Nov. 30, 2013 | Jul. 31, 2013 |
Employee Stock Option [Member] | Restricted Stock [Member] | Employee Stock Option and Restricted Stock [Member] | Employee Stock Option and Restricted Stock [Member] | 2008 Plan [Member] | 2008 Plan [Member] | 2008 Plan [Member] | BioSante Plans [Member] | |||
Restricted Stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | ' | ' | ' | ' | ' | ' | ' | 136 | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | ' | ' | ' | ' | ' | ' | ' | 325 | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 21 | 0 | ' | ' | ' | ' | 21 | ' | ' | ' |
Stock-based compensation expense | ' | ' | ' | ' | $36,000 | $0 | ' | ' | ' | ' |
Share-based Compensation Arrangement By Sharebased Payment Award Options Nonvested Weighted Average Grant Date Fair Value | ' | ' | ' | ' | ' | ' | ' | $3.40 | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms | ' | ' | ' | ' | ' | ' | ' | ' | '2 years 10 months 2 days | ' |
Unrecognized compensation cost (in dollars) | ' | ' | 63,000 | ' | ' | ' | ' | ' | ' | ' |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | '3 years 6 months 11 days | ' | ' | '2 years 10 months 2 days | ' | ' | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | ' | ' | '10 years | ' | ' | ' | ' | ' | ' | ' |
Share Based Compensation Arrangement By Share Based Payment Award Options Assumed In Business Combination | 99 | ' | ' | ' | ' | ' | ' | ' | ' | 99 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | ' | ' | ' | ' | ' | ' | ' | ' | 50 | ' |
Unrecognized compensation cost (in dollars) | ' | ' | ' | $500,000 | ' | ' | ' | ' | ' | ' |
INCOME_TAXES_Details
INCOME TAXES (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Current income tax provision (benefit): | ' | ' |
Federal | $20 | $0 |
State | 0 | 0 |
Total | 20 | 0 |
Deferred income tax provision (benefit): | ' | ' |
Federal | 635 | -1,486 |
State | -221 | -35 |
Total | 414 | -1,522 |
Change in valuation allowance | -414 | 1,522 |
Tax provision (benefit) from continuing operations | 20 | -36 |
Tax provision from discontinued operation | 38 | 36 |
Total provision (benefit) for income taxes | $58 | $0 |
INCOME_TAXES_Details_1
INCOME TAXES (Details 1) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
US Federal statutory rate | 35.00% | -34.00% |
State taxes, net of Federal benefit | 1.00% | -0.90% |
Non-deductible expenses | 245.90% | 17.70% |
Change in valuation allowance | -300.40% | 100.70% |
Change in tax rates and other | 34.60% | -85.70% |
Total income tax provision (benefit) | 16.10% | -2.20% |
INCOME_TAXES_Details_3
INCOME TAXES (Details 3) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Deferred tax assets: | ' | ' |
Accruals and advances | $1,160 | $383 |
Net operating loss carryforward | 16,409 | 11,271 |
Other | 418 | 193 |
Total deferred tax assets | 17,987 | 11,847 |
Deferred tax liabilities: | ' | ' |
Depreciation | -220 | -236 |
Intangible assets | -526 | 0 |
Other | -374 | -52 |
Total deferred tax liabilities | -1,120 | -288 |
Valuation allowance | -16,867 | -11,559 |
Total deferred tax asset (liability), net | $0 | $0 |
INCOME_TAXES_Details_4
INCOME TAXES (Details 4) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
Income Taxes | ' | ' |
Operating Loss Carryforwards | $235,300,000 | ' |
Deferred Tax Assets, Operating Loss Carryforwards, Total | $16,409,000 | $11,271,000 |
COLLABORATIVE_ARRANGEMENTS_Det
COLLABORATIVE ARRANGEMENTS (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Research and Development Expense, Total | $1,712 | $1,158 |
RiconPharma LLC [Member] | ' | ' |
Research and Development Expense, Total | 700 | 200 |
Sofgen Pharmaceuticals [Member] | ' | ' |
Research and Development Expense, Total | $200 | ' |
COMMITMENTS_AND_CONTINGENCIES_1
COMMITMENTS AND CONTINGENCIES (Details) (USD $) | Dec. 31, 2013 |
In Thousands, unless otherwise specified | |
2014 | $148 |
2015 | 78 |
2016 | 53 |
2017 | 44 |
2018 | 29 |
Thereafter | 0 |
Total | $352 |
COMMITMENTS_AND_CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details 2) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
COMMITMENTS AND CONTINGENCIES | ' | ' |
Operating Leases, Rent Expense | $36,000 | $18,000 |
Monitoring And Advisory Fee In Conjunction With Business Combination | 400,000 | ' |
Monitoring And Advisory Fee | 500,000 | 200,000 |
Unapproved Generic Products | ' | ' |
COMMITMENTS AND CONTINGENCIES | ' | ' |
Revenue, Net | 14,600,000 | 6,000,000 |
Unapproved Generic Products | Contract Customer | ' | ' |
COMMITMENTS AND CONTINGENCIES | ' | ' |
Revenue, Net | 2,000,000 | 1,400,000 |
Royalty Revenue, Total | $330,000 | $284,000 |
SUBSEQUENT_EVENTS_Details
SUBSEQUENT EVENTS (Details) (Abbreviated New Drug Applications [Member], Subsequent Event [Member], USD $) | 12 Months Ended | |
In Millions, unless otherwise specified | Dec. 31, 2013 | Jan. 02, 2014 |
Abbreviated New Drug Applications [Member] | Subsequent Event [Member] | ' | ' |
Intangible Asset Purchase Agreement, Amount | $12.50 | ' |
Asset Purchase Agreement First Installment Paid After Balance Sheet Date | ' | $8.50 |
Finite-Lived Intangible Assets, Remaining Amortization Period | '10 years | ' |