Document_And_Entity_Informatio
Document And Entity Information | 3 Months Ended | ||
Mar. 31, 2014 | 2-May-14 | 2-May-14 | |
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 | ' | 11,282,982 | 10,864 |
Document Type | '10-Q | ' | ' |
Amendment Flag | 'false | ' | ' |
Document Period End Date | 31-Mar-14 | ' | ' |
Document Fiscal Period Focus | 'Q1 | ' | ' |
Document Fiscal Year Focus | '2014 | ' | ' |
Condensesd_Consolidated_Balanc
Condensesd Consolidated Balance Sheets (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current Assets | ' | ' |
Cash and cash equivalents | $51,373 | $11,105 |
Accounts receivable, net of $4,874 and $5,104 of allowances for chargebacks and other allowances at March 31, 2014 and December 31, 2013, respectively | 10,907 | 12,513 |
Inventories, net | 5,090 | 3,518 |
Prepaid expenses | 566 | 580 |
Total Current Assets | 67,936 | 27,716 |
Property, plant, and equipment, net | 4,518 | 4,537 |
Intangible assets, net | 22,360 | 10,409 |
Goodwill | 1,838 | 1,838 |
Total Assets | 96,652 | 44,500 |
Current Liabilities | ' | ' |
Accounts payable | 2,660 | 1,429 |
Accrued expenses | 1,013 | 1,326 |
Returned goods reserve | 849 | 736 |
Deferred revenue | 38 | 47 |
Total Current Liabilities | 4,560 | 3,538 |
Commitments and Contingencies (Note 11) | ' | ' |
Stockholders' Equity | ' | ' |
Preferred Stock, $0.0001 par value, 1,666,667 shares authorized; 0 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively | 0 | 0 |
Treasury stock, 9,233 shares of common stock, at cost, at March 31, 2014 and December 31, 2013 | -68 | -68 |
Additional paid-in capital | 137,272 | 89,501 |
Accumulated deficit | -45,113 | -48,472 |
Total Stockholders' Equity | 92,092 | 40,962 |
Total Liabilities and Stockholders' Equity | 96,652 | 44,500 |
Common stock | ' | ' |
Stockholders' Equity | ' | ' |
Common Stock Value | 1 | 1 |
Class C special stock | ' | ' |
Stockholders' Equity | ' | ' |
Common Stock Value | $0 | $0 |
Condensesd_Consolidated_Balanc1
Condensesd Consolidated Balance Sheets [Parenthetical] (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, except Share data, unless otherwise specified | ||
Adjustments for chargebacks and other allowances | $4,874 | $5,104 |
Treasury Stock, Shares | 9,233 | 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 | 11,292,215 | 9,629,174 |
Common Stock, Outstanding Shares | 11,282,982 | 9,619,941 |
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 | 10,864 | 10,864 |
Common Stock, Outstanding Shares | 10,864 | 10,864 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | |
Net Revenues | $10,899 | $5,562 | |
Operating Expenses | ' | ' | |
Cost of sales (excluding depreciation and amortization) | 2,622 | 2,408 | |
Research and development | 376 | 296 | |
Selling, general and administrative | 3,703 | 2,310 | |
Depreciation and amortization | 703 | 145 | |
Total Operating Expenses | 7,404 | 5,159 | |
Operating Income | 3,495 | 403 | |
Other Income/(Expense) | ' | ' | |
Interest expense | 0 | -93 | |
Other income/(expense) | 29 | -50 | |
Income Before Provision for Income Taxes | 3,524 | 260 | |
Provision for income taxes | -165 | 0 | |
Net Income | 3,359 | 260 | |
Computation of Income/(Loss) Attributable to Common Stockholders: | ' | ' | |
Net Income | 3,359 | 260 | |
Preferred stock dividends | 0 | -2,604 | |
Income/(Loss) Attributable to Common Stockholders | $3,359 | ($2,344) | |
Basic and Diluted Earnings/(Loss) Per Share: | ' | ' | |
Basic Earnings/(Loss) Per Share (in dollars per share) | $0.33 | $0 | [1] |
Diluted Earnings/(Loss) Per Share (in dollars per share) | $0.33 | $0 | [1] |
Basic Weighted-Average Shares Outstanding (in shares) | 9,991 | 0 | [1] |
Diluted Weighted-Average Shares Outstanding (in shares) | 10,001 | 0 | [1] |
[1] | Earnings/(loss) 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 4 for further details. |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Cash Flows From Operating Activities | ' | ' |
Net income | $3,359 | $260 |
Adjustments to reconcile net income to net cash and cash equivalents provided by/(used in) operating activities: | ' | ' |
Stock-based compensation | 47 | 0 |
Depreciation and amortization | 703 | 145 |
Non-cash interest relating to equity-linked securities and loan cost amortization | 0 | 22 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable | 1,606 | -472 |
Inventories | -1,572 | -228 |
Prepaid expenses | 14 | 78 |
Accounts payable | 1,231 | 100 |
Accrued expenses, returned goods reserve and deferred revenue | -209 | -139 |
Net Cash and Cash Equivalents Provided by/(Used in) Operating Activities | 5,179 | -234 |
Cash Flows From Investing Activities | ' | ' |
Acquisition of intangible assets | -12,517 | 0 |
Acquisition of property and equipment | -118 | -108 |
Net Cash and Cash Equivalents Used in Investing Activities | -12,635 | -108 |
Cash Flows From Financing Activities | ' | ' |
Net proceeds from equity offering | 46,694 | 0 |
Borrowings under line of credit, net | 0 | 372 |
Proceeds from stock option exercises | 743 | 0 |
Proceeds from warrant exercises | 180 | 0 |
Excess tax benefit from share-based compensation awards | 107 | 0 |
Net Cash and Cash Equivalents Provided by Financing Activities | 47,724 | 372 |
Change in Cash and Cash Equivalents | 40,268 | 30 |
Cash and cash equivalents, beginning of period | 11,105 | 11 |
Cash and cash equivalents, end of period | 51,373 | 41 |
Supplemental disclosure for cash flow information: | ' | ' |
Cash paid for interest | 0 | 71 |
Cash paid for income taxes | 60 | 0 |
Supplemental non-cash investing and financing activities: | ' | ' |
Preferred stock dividends accrued | $0 | $2,604 |
BUSINESS_PRESENTATION_AND_RECE
BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS | 3 Months Ended | ||
Mar. 31, 2014 | |||
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ||
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ||
1 | BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS | ||
Overview | |||
ANI Pharmaceuticals, Inc. and subsidiary, ANIP Acquisition Company (together, the “Company,” “we,” or “us”) is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. Our targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. We have two pharmaceutical manufacturing facilities located in Baudette, Minnesota, which are capable of producing oral solid dose products, as well as liquids and topicals, narcotics, and potent products that must be manufactured in a fully-contained environment. Our strategy is to continue to use these manufacturing assets to develop, produce, and distribute niche generic pharmaceutical products. | |||
On June 19, 2013, pursuant to a merger agreement dated as of April 12, 2013, ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc. ("ANIP") became a wholly-owned subsidiary of BioSante Pharmaceuticals, Inc. (“BioSante”) in an all-stock, tax-free reorganization (the "Merger"). The Merger was accounted for as a reverse acquisition, pursuant to which ANIP was considered the acquiring entity for accounting purposes. BioSante was renamed ANI Pharmaceuticals, Inc. We now operate under the leadership of the ANIP management team and our board of directors is comprised of two former BioSante directors and five former ANIP directors. 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 our consolidated financial statements for all periods after completion of the Merger. | |||
Basis of Presentation | |||
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In our opinion, the accompanying unaudited interim condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations and cash flows. The condensed consolidated balance sheet at December 31, 2013, has been derived from audited financial statements of that date. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules and regulations prescribed by the United States Securities and Exchange Commission. We believe that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in our annual report on Form 10-K for the year ended December 31, 2013. Certain prior period information has been reclassified to conform to the current period presentation. | |||
Principles of Consolidation | |||
The condensed consolidated financial statements include the accounts of ANI Pharmaceuticals, Inc. and its wholly owned subsidiary, ANIP. All significant inter-company accounts and transactions are eliminated in consolidation. | |||
Use of Estimates | |||
The preparation of financial statements in conformity with U.S. GAAP requires us 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 unaudited condensed 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, allowances for contingencies and litigation, fair value of long-lived assets, deferred taxes and valuation allowance, and the depreciable lives of long-lived assets. Actual results could differ from those estimates. | |||
Recent Accounting Pronouncements | |||
In July 2013, the Financial Accounting Standards Board (“FASB”) issued guidance for the presentation of an unrecognized tax benefit when a net operating loss ("NOL") carryforward, a similar tax loss, or a tax credit carryforward exists. The guidance requires an entity to present in the financial statements an unrecognized tax benefit, or a portion of an unrecognized tax benefit, as a reduction to a deferred tax asset for an NOL carryforward, a similar tax loss, or a tax credit carryforward. If the NOL carryforward, a similar tax loss, or a tax credit carryforward is not available at the reporting date under the tax law of the jurisdiction or the tax law of the jurisdiction does not require the entity to use, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit will be presented in the financial statements as a liability and will not be combined with deferred tax assets. This guidance does not require any additional recurring disclosures and is effective for fiscal years beginning after December 15, 2013. The adoption of this guidance did not have a material impact on our financial statements. | |||
We have evaluated all issued and unadopted Accounting Standards Updates and believe the adoption of these standards will not have a material impact on our results of operations, financial position, or cash flows. | |||
REVENUE_RECOGNITION_AND_RELATE
REVENUE RECOGNITION AND RELATED ALLOWANCES | 3 Months Ended | |||||||||||||
Mar. 31, 2014 | ||||||||||||||
Revenue Recognition [Abstract] | ' | |||||||||||||
Revenue Recognition | ' | |||||||||||||
2 | Revenue Recognition AND RELATED ALLOWANCES | |||||||||||||
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 we have 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 unaudited condensed consolidated statements of operations, and are presented as current liabilities or reductions in accounts receivable in the accompanying unaudited condensed consolidated balance sheets (see “Accruals for Chargebacks, Returns, and Other Allowances”). Historically, we have not entered into revenue arrangements with multiple elements. | ||||||||||||||
Occasionally, we engage 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 we have a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured, and we have no further performance obligations under the agreement. | ||||||||||||||
Accruals for Chargebacks, Returns and Other Allowances | ||||||||||||||
Our 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. We accrue for these items at the time of sale and continually monitor and re-evaluate the accruals as additional information becomes available. We adjust 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 the customer or upon issuance of credit to the customer. | ||||||||||||||
The following table summarizes activity in the balance sheet for accruals and allowances for the three-month periods ended March 31, 2014 and 2013, respectively: | ||||||||||||||
(in thousands) | Accruals for Chargebacks, Returns and Other Allowances | |||||||||||||
Administrative | Prompt | |||||||||||||
Fees and Other | Payment | |||||||||||||
Chargebacks | Returns | Rebates | Discounts | |||||||||||
Balance at December 31, 2012 | 5,662 | 411 | 231 | 242 | ||||||||||
Accruals/Adjustments | 5,579 | 120 | 559 | 199 | ||||||||||
Credits Taken Against Reserve | -7,903 | -155 | -516 | -244 | ||||||||||
Balance at March 31, 2013 | $ | 3,338 | $ | 376 | $ | 274 | $ | 197 | ||||||
Balance at December 31, 2013 | 4,076 | 736 | 735 | 332 | ||||||||||
Accruals/Adjustments | 7,090 | 258 | 970 | 347 | ||||||||||
Credits Taken Against Reserve | -7,357 | -145 | -853 | -370 | ||||||||||
Balance at March 31, 2014 | $ | 3,809 | $ | 849 | $ | 852 | $ | 309 | ||||||
Credit Concentration | ||||||||||||||
Our customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and pharmaceutical companies. | ||||||||||||||
During the three month period ended March 31, 2014, three customers represented 23%, 18%, and 15% of net revenues. As of March 31, 2014, accounts receivable from these customers totaled $8.0 million. During the three month period ended March 31, 2013, three customers represented 26%, 17%, and 14% of net revenues. | ||||||||||||||
BUSINESS_COMBINATION
BUSINESS COMBINATION | 3 Months Ended | ||||
Mar. 31, 2014 | |||||
BUSINESS COMBINATION | ' | ||||
BUSINESS COMBINATION | ' | ||||
3 | BUSINESS COMBINATION | ||||
Summary | |||||
On June 19, 2013, BioSante acquired ANIP in an all-stock, tax-free reorganization. We are 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 our consolidated financial statements for all periods after completion of the Merger. Former BioSante operations did not generate any revenue or expense during the three months ended March 31, 2014. | |||||
Transaction Costs | |||||
In conjunction with the Merger, we incurred approximately $7.1 million in transaction costs, which were expensed in the periods in which they were incurred. These costs 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, $0.1 million was incurred and expensed in the three months ended March 31, 2013 as selling, general and administrative expense. No transaction-related expenses were incurred in the three months ended March 31, 2014. | |||||
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, we 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. | |||||
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 convertible debt, (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 been obtained if the Merger had occurred as of January 1, 2012 or that may be obtained in the future. | |||||
(in thousands) | Three months ended | ||||
March 31, | |||||
2013 | |||||
Net revenues | $ | 5,707 | |||
Net loss | $ | -1,601 | |||
EARNINGSLOSS_PER_SHARE
EARNINGS/(LOSS) PER SHARE | 3 Months Ended | |||||||
Mar. 31, 2014 | ||||||||
Earnings Per Share [Abstract] | ' | |||||||
Earnings Per Share | ' | |||||||
4 | Earnings/(LOSS) per Share | |||||||
Basic earnings/(loss) per share is computed by dividing net income available to common shareholders by the weighted-average number of shares of common stock outstanding during the period. | ||||||||
Our unvested restricted shares and certain of our outstanding warrants contain non-forfeitable rights to dividends, and therefore are considered to be participating securities; the calculation of basic and diluted earnings/(loss) per share excludes net income (but not net loss) attributable to the unvested restricted shares and to the participating warrants from the numerator and excludes the impact of those shares from the denominator. The numerator for earnings per share for the three months ended March 31, 2014 is calculated for basic and diluted earnings per share as follows: | ||||||||
(in thousands) | Three months ended March 31, 2014 | |||||||
Basic | Diluted | |||||||
Net income | $ | 3,359 | $ | 3,359 | ||||
Net income allocated to warrants | -19 | $ | -19 | |||||
Net income allocated to restricted stock | -15 | $ | -15 | |||||
Net income allocated to common shares | $ | 3,325 | $ | 3,325 | ||||
For periods of net income, and when the effects are not anti-dilutive, we calculate diluted earnings per share 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. | ||||||||
The number of anti-dilutive shares, which have been excluded from the computation of diluted earnings/(loss) per share, was 0.7 million and 4.9 million for the three month periods ended March 31, 2014 and 2013. Anti-dilutive shares consist of Class C Special stock, out-of-the-money common stock options, out-of-the-money warrants exercisable for common stock, and certain participating securities, if the effect of including both the income allocated to the participating security and the impact of the potential common shares would be anti-dilutive. Prior to the Merger (Note 3), anti-dilutive shares included equity-linked securities, convertible preferred stock, and stock purchase warrants exercisable for preferred stock. | ||||||||
For periods prior to the Merger, earnings/(loss) 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 March 31, 2014, we had 90 thousand options to purchase common stock, 50 thousand unvested restricted stock awards, and 555 thousand warrants to purchase common stock outstanding. | ||||||||
INVENTORIES
INVENTORIES | 3 Months Ended | |||||||
Mar. 31, 2014 | ||||||||
INVENTORIES | ' | |||||||
INVENTORIES | ' | |||||||
5 | INVENTORIES | |||||||
Inventories consist of the following as of: | ||||||||
(in thousands) | March 31, | December 31, | ||||||
2014 | 2013 | |||||||
Raw materials | $ | 3,483 | $ | 1,480 | ||||
Packaging materials | 732 | 766 | ||||||
Work-in-progress | 200 | 162 | ||||||
Finished goods | 709 | 1,152 | ||||||
5,124 | 3,560 | |||||||
Reserve for excess/obsolete inventories | -34 | -42 | ||||||
Inventories, net | $ | 5,090 | $ | 3,518 | ||||
Vendor Concentration | ||||||||
We source the raw materials for our 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, we are dependent upon our current vendors to supply reliably the API required for ongoing product manufacturing. During the three months ended March 31, 2014, we purchased approximately 49% of our inventory from two suppliers. As of March 31, 2014, amounts payable to these suppliers was immaterial. During the three months ended March 31, 2013, we purchased approximately 43% of our inventory from three suppliers. | ||||||||
PROPERTY_PLANT_AND_EQUIPMENT
PROPERTY, PLANT, AND EQUIPMENT | 3 Months Ended | |||||||
Mar. 31, 2014 | ||||||||
Property, Plant and Equipment [Abstract] | ' | |||||||
PROPERTY, PLANT, AND EQUIPMENT | ' | |||||||
6 | PROPERTY, PLANT, AND EQUIPMENT | |||||||
Property, plant, and equipment consist of the following as of: | ||||||||
(in thousands) | March 31, | December 31, | ||||||
2014 | 2013 | |||||||
Land | $ | 87 | $ | 87 | ||||
Buildings | 3,682 | 3,682 | ||||||
Machinery, furniture and equipment | 4,017 | 3,736 | ||||||
Construction in progress | 66 | 229 | ||||||
7,852 | 7,734 | |||||||
Less: accumulated depreciation | -3,334 | -3,197 | ||||||
Property, Plant and Equipment, net | $ | 4,518 | $ | 4,537 | ||||
Depreciation expense for the three month periods ended March 31, 2014 and 2013 totaled $137 thousand and $132 thousand, respectively. During the three month periods ended March 31, 2014 and 2013, there was no material interest capitalized into construction in progress. | ||||||||
GOODWILL_AND_INTANGIBLE_ASSETS
GOODWILL AND INTANGIBLE ASSETS | 3 Months Ended | |||||||||||||||
Mar. 31, 2014 | ||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ' | |||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ' | |||||||||||||||
7 | GOODWILL AND INTANGIBLE ASSETS | |||||||||||||||
Goodwill | ||||||||||||||||
As a result of the Merger (Note 3), we recorded goodwill of $1.8 million in our one reporting unit. We assess the recoverability of the carrying value of goodwill 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 our reporting unit below its carrying value. There have been no events or changes in circumstances that would have reduced the fair value of our reporting unit below its carrying value from the most recent assessment on October 31, 2013, through March 31, 2014. No impairment losses were recognized during the three months ended March 31, 2014. | ||||||||||||||||
Acquisition of Abbreviated New Drug Applications | ||||||||||||||||
On December 26, 2013, we entered into an agreement to purchase (the “Teva Purchase Agreement”) Abbreviated New Drug Applications (“ANDAs”) to produce 31 generic drug products from Teva Pharmaceuticals (“Teva”) for $12.5 million in cash and a percentage of future gross profits from product sales. According to the terms of the Teva Purchase Agreement, Teva was required to provide soft copy materials and transfer ownership of the ANDAs to us within five business days of signing the Teva Purchase Agreement, and we were required to pay the first installment of $8.5 million upon receipt thereof. Teva provided the soft copy materials and transferred ownership of the ANDAs to us on January 2, 2014 and we paid the first installment of $8.5 million to Teva on January 2, 2014. Teva was also required to provide hard copy materials to us within 90 days of signing the Teva Purchase Agreement. Teva provided the hard copy materials on March 5, 2014 and we paid the $4.0 million balance on March 6, 2014. | ||||||||||||||||
The drug products include 20 solid-oral immediate release products, four extended release products and seven liquid products. We performed an assessment of the assets purchased and determined that this transaction was an asset purchase and not a business combination. The ANDAs are being amortized in full over their useful lives, averaging 10 years. | ||||||||||||||||
Definite-Lived Intangible Assets | ||||||||||||||||
The components of our definite-lived intangible assets are as follows: | ||||||||||||||||
(in thousands) | March 31, 2014 | December 31, 2013 | ||||||||||||||
Gross Carrying | Accumulated | Gross Carrying | Accumulated | Amortization | ||||||||||||
Amount | Amortization | Amount | Amortization | Period | ||||||||||||
Acquired ANDA intangible assets | $ | 12,577 | $ | -373 | $ | 60 | $ | -55 | 3-10 years | |||||||
Reglan® intangible asset | 100 | -100 | 100 | -100 | 2 years | |||||||||||
Teva license intangible asset | 10,900 | -744 | 10,900 | -496 | 11 years | |||||||||||
$ | 23,577 | $ | -1,217 | $ | 11,060 | $ | -651 | |||||||||
Our acquired ANDAs 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 that we acquired from various companies, including those acquired pursuant to the Teva Purchase Agreement. The Teva license was acquired as part of the Merger (Note 3). Definite-lived 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 $13 thousand for the three months ended March 31, 2014 and 2013, respectively. | ||||||||||||||||
We test 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 during the three months ended March 31, 2014 and 2013 and therefore no impairment loss was recognized in the three months ended March 31, 2014 or 2013. | ||||||||||||||||
Expected future amortization expense is as follows: | ||||||||||||||||
(in thousands) | ||||||||||||||||
2014 (remainder of the year) | $ | 1,682 | ||||||||||||||
2015 | 2,243 | |||||||||||||||
2016 | 2,243 | |||||||||||||||
2017 | 2,243 | |||||||||||||||
2018 | 2,243 | |||||||||||||||
2019 and thereafter | 11,706 | |||||||||||||||
Total | $ | 22,360 | ||||||||||||||
STOCKBASED_COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended | |
Mar. 31, 2014 | ||
STOCK-BASED COMPENSATION | ' | |
STOCK-BASED COMPENSATION | ' | |
8 | STOCK-BASED COMPENSATION | |
All stock options and restricted stock are granted under the ANI Pharmaceuticals, Inc. Amended and Restated 2008 Stock Incentive Plan (the “2008 Plan”). As of March 31, 2014, 154 thousand shares of our common stock remained available for issuance under the 2008 Plan. | ||
On April 1, 2014, the Board of Directors approved grants of options to purchase 59 thousand shares of common stock and 30 thousand shares of restricted stock to our officers and options to purchase 16 thousand shares of common stock to non-employee directors. While the stock options were granted with no restrictions, the restricted stock was granted subject to shareholder approval of an increase in the total restricted stock that can be granted under the 2008 Plan. | ||
On July 12, 2013, our 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 March 31, 2014, we had 325 thousand common stock options outstanding pending shareholder approval. Expense related to these stock options and the restricted stock granted on April 1, 2014 will begin to be recognized upon shareholder approval. | ||
In 2013, the Board of Directors granted options to purchase 21 thousand shares of common stock and 50 thousand shares of restricted stock to non-officer directors under the 2008 Plan. Total expense related to these options and shares of restricted stock was $47 thousand during the three months ended March 31, 2014. | ||
Options to purchase 30 thousand shares of common stock were exercised and no options expired during the three month period ended March 31, 2014. No options were exercised and no options expired during the three months ended March 31, 2013. No restricted stock vested or was forfeited during the three months ended March 31, 2014 or 2013. | ||
STOCKHOLDERS_EQUITY
STOCKHOLDER'S EQUITY | 3 Months Ended | |
Mar. 31, 2014 | ||
Stockholders Equity Note [Abstract] | ' | |
Stockholders Equity Note Disclosure | ' | |
9 | STOCKHOLDER’S EQUITY | |
On March 10, 2014, we completed a follow-on public offering of 1.6 million shares of our common stock at a public offering price of $31.00 per share (the “March 2014 Offering”). We received gross proceeds of $50.0 million, or net proceeds of $46.7 million after deducting costs of $3.3 million, including the underwriters’ fees and commissions, as well as expenses directly related to the March 2014 Offering. The number of shares sold in the March 2014 Offering includes the exercise in full by the underwriters of their option to purchase an additional 0.2 million shares of common stock. | ||
In January 2014, warrants to purchase an aggregate of 20 thousand shares of common stock were exercised at $9.00 per share. During the three months ended March 31, 2014, warrants to purchase an aggregate of 112 thousand shares of common stock expired unexercised. | ||
INCOME_TAXES
INCOME TAXES | 3 Months Ended | |
Mar. 31, 2014 | ||
INCOME TAXES | ' | |
INCOME TAXES | ' | |
10 | INCOME TAXES | |
We use 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. Based upon historical losses and uncertainty of future taxable income, we have fully reserved for all our deferred tax assets as of March 31, 2014 and December 31, 2013. For interim periods, we recognize an income tax provision/(benefit) based on our estimated annual effective tax rate expected for the entire year. We calculate income tax benefits related to stock-based compensation arrangements using the with and without approach. | ||
We use 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. We have not identified any uncertain income tax positions that could have a material impact on the financial statements. We are subject to taxation in various jurisdictions and remain subject to examination by taxing jurisdictions for the years 1998 and all subsequent periods due to the availability of NOL carryforwards. | ||
We recognize interest and penalties accrued on any unrecognized tax exposures as a component of income tax expense. We did not have any amounts accrued relating to interest and penalties as of March 31, 2014 and December 31, 2013. | ||
The effective tax rate for the three months ended March 31, 2014 was 4.6% of net income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2014. The effective tax rate for the period was primarily impacted by the use of the NOL carryforwards. The utilization of these NOL carryforwards will be limited in future years as prescribed by Section 382 of the U.S. Internal Revenue Code. For the comparable three month period ended March 31, 2013, we did not have a tax provision due to the projected loss for the year, accumulated losses, which resulted in NOL carryforwards, and a full valuation allowance. | ||
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended | |
Mar. 31, 2014 | ||
COMMITMENTS AND CONTINGENCIES | ' | |
COMMITMENTS AND CONTINGENCIES | ' | |
11 | COMMITMENTS AND CONTINGENCIES | |
Operating Leases | ||
We lease equipment under operating leases that expire in May 2017. We also lease office space under operating leases that expire beginning in February 2016 through September 2018. Future minimum lease payments due under these leases total $261 thousand as of March 31, 2014. | ||
Rent expense for the three month periods ended March 31, 2014 and 2013 totaled $17 thousand and $5 thousand, respectively. | ||
Government Regulation | ||
Our 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 our products. The Drug Enforcement Administration (“DEA”) maintains oversight over our products that are controlled substances. | ||
Unapproved Products | ||
Two of our products, Esterified Estrogen with Methyltestosterone tablets (“EEMT”) and Opium Tincture, are marketed without approved New Drug Applications (“NDAs”) or ANDAs. In March 2014, we formally requested a pre-IND meeting with the FDA to discuss applying for an NDA for our Opium Tincture product. During the three month periods ended March 31, 2014 and 2013, net revenues for these products totaled $6.7 million and $1.5 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, 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. We believe that, so long as we comply with applicable manufacturing and labeling standards, the FDA will not take action against us 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, we may be required to seek FDA approval for these products or withdraw such products from the market. If we decide to withdraw the products from the market, our net revenues for generic pharmaceutical products would decline materially, and if we decide to seek FDA approval, we would face increased expenses and might need to suspend sales of the products until such approval was obtained, and there are no assurances that we would receive such approval. | ||
In addition, one group of products that we manufacture 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. Our contract manufacturing revenues for these unapproved products for the three month periods ended March 31, 2014 and 2013 were $0.4 million and $0.5 million, respectively. | ||
We receive 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. Our royalties on the net sales of these unapproved products for each of the three month periods ended March 31, 2014 and 2013 were $0.1 million. | ||
In October 2012, we 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. Our counsel sent a letter to the FDA on November 9, 2012 in support of our position. On April 2, 2014, we received communication from the FDA confirming that the inspection was closed. | ||
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 BioSante Pharmaceuticals, Inc. and our former President and Chief Executive Officer, Stephen M. Simes, as defendants. The complaint alleges that certain of our 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 our 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 our 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, we 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 BioSante, 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 our directors as defendants and BioSante 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 reforms and improvements in our 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. We believe the state court complaint is without merit and will continue to defend the action vigorously. | ||
We are 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 our operations. Depending on the outcome or resolution of the remaining lawsuit, it could have a material effect on our operations, including our financial condition, results of operations, or cash flows. No amounts have been accrued related to this legal action as of March 31, 2014. | ||
Louisiana Medicaid Lawsuit | ||
On September 11, 2013, the Attorney General of the State of Louisiana filed a lawsuit in Louisiana state court against numerous pharmaceutical companies, including us, 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 our former Gulfport, Mississippi operation, which was sold in September 2010. Through its lawsuit, the state seeks unspecified damages, statutory fines, penalties, attorneys’ 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 we cannot predict the outcome of the lawsuit at this time, it could be subject to material damages, penalties and fines. We intend 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 us, 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. We have been named and served in 92 separate complaints, including three in Pennsylvania, nine in New Jersey, and 80 in California, covering 2,944 plaintiffs in total. In August 2012, we were dismissed with prejudice from all New Jersey cases. We consider our exposure to this litigation to be limited due to several factors: (1) the only generic metoclopramide manufactured by us prior to the implementation of the FDA's warning requirement was an oral solution introduced after May 28, 2008; (2) our market share for the oral solution was a very small portion of the overall metoclopramide market; and (3) once we received a request for change of labeling from the FDA, we submitted our proposed changes within 30 days, and such changes were subsequently approved by the FDA. At the present time, we are unable to assess the likely outcome of the remaining cases. Our insurance company has assumed the defense of this matter. In addition, our insurance company renewed our product liability insurance on September 1, 2012 and 2013 with absolute exclusions for claims related to Reglan® and metoclopramide. We are 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 our operations. Furthermore, we cannot provide assurances that the outcome of these matters will not have an adverse effect on our business, results of operations, financial condition, and cash flow. Like all pharmaceutical manufacturers, we in the future may be exposed to other product liability claims, which could harm our business, results of operations, financial condition, and cash flows. | ||
FAIR_VALUE_DISCLOSURES
FAIR VALUE DISCLOSURES | 3 Months Ended | |||||||||||||
Mar. 31, 2014 | ||||||||||||||
FAIR VALUE DISCLOSURES | ' | |||||||||||||
FAIR VALUE DISCLOSURES | ' | |||||||||||||
12 | 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 that 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 our 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. | ||||||||||||||
Our CVRs, which were granted coincident with the Merger (Note 3), are considered 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 our projection of the expected payments pursuant to the terms of the CVR agreement, which is the primary unobservable input. If our 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%. We determined that the fair value of the CVRs, and the changes in such fair value, was immaterial as of and for the three months ended March 31, 2014. | ||||||||||||||
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 that 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. We determined that the fair value of the derivative liabilities, and the changes in such fair value, was immaterial as of and for the three months ended March 31, 2013. All such stock purchase warrants expired in connection with the Merger. | ||||||||||||||
The following table presents our financial assets and liabilities accounted for at fair value on a recurring basis as of March 31, 2014 and December 31, 2013, by level within the fair value hierarchy: | ||||||||||||||
(in thousands) | ||||||||||||||
Description | Fair Value at | Level 1 | Level 2 | Level 3 | ||||||||||
March 31, 2014 | ||||||||||||||
Liabilities | ||||||||||||||
CVRs | $ | - | $ | - | $ | - | $ | - | ||||||
Description | Fair Value at | Level 1 | Level 2 | Level 3 | ||||||||||
31-Dec-13 | ||||||||||||||
Liabilities | ||||||||||||||
CVRs | $ | - | $ | - | $ | - | $ | - | ||||||
Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||||||||||||||
We do not have any 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 | ||||||||||||||
We measure our 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 three months ended March 31, 2014 and 2013. | ||||||||||||||
SUBSEQUENT_EVENTS
SUBSEQUENT EVENTS | 3 Months Ended | ||
Mar. 31, 2014 | |||
Subsequent Events [Abstract] | ' | ||
SUBSEQUENT EVENTS | ' | ||
13 | SUBSEQUENT EVENT | ||
In April 2014, we entered into a collaboration agreement with Sofgen Pharmaceuticals to develop an oral soft gel prescription product (the “April 2014 Sofgen Agreement”). The product 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, and we will provide payments based on the completion of certain milestones. Upon approval, Sofgen will manufacture the drug and we will be responsible for the marketing and distribution, under our label, of the product in the United States, providing a percentage of profits from sales of the drug to Sofgen. | |||
Under the April 2014 Sofgen Agreement, Sofgen will own all the rights, title and interest in the product. During the term of the April 2014 Sofgen Agreement, both parties are prohibited from developing, selling or distributing any product in the United States that is identical or bioequivalent to the product covered under the April 2014 Sofgen Agreement. The April 2014 Sofgen Agreement can be terminated or amended under certain specified circumstances. The April 2014 Sofgen Agreement has an initial term of ten years from the launch of the product, which term will automatically renew for two year terms until either party terminates the agreement. | |||
BUSINESS_PRESENTATION_AND_RECE1
BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS (Policies) | 3 Months Ended |
Mar. 31, 2014 | |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' |
Overview | ' |
Overview | |
ANI Pharmaceuticals, Inc. and subsidiary, ANIP Acquisition Company (together, the “Company,” “we,” or “us”) is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. Our targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. We have two pharmaceutical manufacturing facilities located in Baudette, Minnesota, which are capable of producing oral solid dose products, as well as liquids and topicals, narcotics, and potent products that must be manufactured in a fully-contained environment. Our strategy is to continue to use these manufacturing assets to develop, produce, and distribute niche generic pharmaceutical products. | |
On June 19, 2013, pursuant to a merger agreement dated as of April 12, 2013, ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc. ("ANIP") became a wholly-owned subsidiary of BioSante Pharmaceuticals, Inc. (“BioSante”) in an all-stock, tax-free reorganization (the "Merger"). The Merger was accounted for as a reverse acquisition, pursuant to which ANIP was considered the acquiring entity for accounting purposes. BioSante was renamed ANI Pharmaceuticals, Inc. We now operate under the leadership of the ANIP management team and our board of directors is comprised of two former BioSante directors and five former ANIP directors. 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 our consolidated financial statements for all periods after completion of the Merger. | |
Basis of Presentation | ' |
Basis of Presentation | |
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In our opinion, the accompanying unaudited interim condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations and cash flows. The condensed consolidated balance sheet at December 31, 2013, has been derived from audited financial statements of that date. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules and regulations prescribed by the United States Securities and Exchange Commission. We believe that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in our annual report on Form 10-K for the year ended December 31, 2013. Certain prior period information has been reclassified to conform to the current period presentation. | |
Principles of consolidation | ' |
Principles of Consolidation | |
The condensed consolidated financial statements include the accounts of ANI Pharmaceuticals, Inc. and its wholly owned subsidiary, ANIP. All significant inter-company 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 us 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 unaudited condensed 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, allowances for contingencies and litigation, fair value of long-lived assets, deferred taxes and valuation allowance, and the depreciable lives of long-lived assets. Actual results could differ from those estimates. | |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements | |
In July 2013, the Financial Accounting Standards Board (“FASB”) issued guidance for the presentation of an unrecognized tax benefit when a net operating loss ("NOL") carryforward, a similar tax loss, or a tax credit carryforward exists. The guidance requires an entity to present in the financial statements an unrecognized tax benefit, or a portion of an unrecognized tax benefit, as a reduction to a deferred tax asset for an NOL carryforward, a similar tax loss, or a tax credit carryforward. If the NOL carryforward, a similar tax loss, or a tax credit carryforward is not available at the reporting date under the tax law of the jurisdiction or the tax law of the jurisdiction does not require the entity to use, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit will be presented in the financial statements as a liability and will not be combined with deferred tax assets. This guidance does not require any additional recurring disclosures and is effective for fiscal years beginning after December 15, 2013. The adoption of this guidance did not have a material impact on our financial statements. | |
We have evaluated all issued and unadopted Accounting Standards Updates and believe the adoption of these standards will not have a material impact on our results of operations, financial position, or cash flows. | |
REVENUE_RECOGNITION_AND_RELATE1
REVENUE RECOGNITION AND RELATED ALLOWANCES (Tables) | 3 Months Ended | |||||||||||||
Mar. 31, 2014 | ||||||||||||||
Revenue Recognition [Abstract] | ' | |||||||||||||
Schedule of Valuation and Qualifying Accounts Disclosure | ' | |||||||||||||
The following table summarizes activity in the balance sheet for accruals and allowances for the three-month periods ended March 31, 2014 and 2013, respectively: | ||||||||||||||
(in thousands) | Accruals for Chargebacks, Returns and Other Allowances | |||||||||||||
Administrative | Prompt | |||||||||||||
Fees and Other | Payment | |||||||||||||
Chargebacks | Returns | Rebates | Discounts | |||||||||||
Balance at December 31, 2012 | 5,662 | 411 | 231 | 242 | ||||||||||
Accruals/Adjustments | 5,579 | 120 | 559 | 199 | ||||||||||
Credits Taken Against Reserve | -7,903 | -155 | -516 | -244 | ||||||||||
Balance at March 31, 2013 | $ | 3,338 | $ | 376 | $ | 274 | $ | 197 | ||||||
Balance at December 31, 2013 | 4,076 | 736 | 735 | 332 | ||||||||||
Accruals/Adjustments | 7,090 | 258 | 970 | 347 | ||||||||||
Credits Taken Against Reserve | -7,357 | -145 | -853 | -370 | ||||||||||
Balance at March 31, 2014 | $ | 3,809 | $ | 849 | $ | 852 | $ | 309 | ||||||
BUSINESS_COMBINATION_Tables
BUSINESS COMBINATION (Tables) | 3 Months Ended | ||||
Mar. 31, 2014 | |||||
BUSINESS COMBINATION | ' | ||||
Business Combination Transaction Costs | ' | ||||
These costs 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 been obtained if the Merger had occurred as of January 1, 2012 or that may be obtained in the future. | |||||
(in thousands) | Three months ended | ||||
March 31, | |||||
2013 | |||||
Net revenues | $ | 5,707 | |||
Net loss | $ | -1,601 | |||
EARNINGSLOSS_PER_SHARE_Tables
EARNINGS/(LOSS) PER SHARE (Tables) | 3 Months Ended | |||||||
Mar. 31, 2014 | ||||||||
Earnings Per Share [Abstract] | ' | |||||||
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | ' | |||||||
The numerator for earnings per share for the three months ended March 31, 2014 is calculated for basic and diluted earnings per share as follows: | ||||||||
(in thousands) | Three months ended March 31, 2014 | |||||||
Basic | Diluted | |||||||
Net income | $ | 3,359 | $ | 3,359 | ||||
Net income allocated to warrants | -19 | $ | -19 | |||||
Net income allocated to restricted stock | -15 | $ | -15 | |||||
Net income allocated to common shares | $ | 3,325 | $ | 3,325 | ||||
INVENTORIES_Tables
INVENTORIES (Tables) | 3 Months Ended | |||||||
Mar. 31, 2014 | ||||||||
INVENTORIES | ' | |||||||
Schedule of Inventory, Current | ' | |||||||
Inventories consist of the following as of: | ||||||||
(in thousands) | March 31, | December 31, | ||||||
2014 | 2013 | |||||||
Raw materials | $ | 3,483 | $ | 1,480 | ||||
Packaging materials | 732 | 766 | ||||||
Work-in-progress | 200 | 162 | ||||||
Finished goods | 709 | 1,152 | ||||||
5,124 | 3,560 | |||||||
Reserve for excess/obsolete inventories | -34 | -42 | ||||||
Inventories, net | $ | 5,090 | $ | 3,518 | ||||
PROPERTY_PLANT_AND_EQUIPMENT_T
PROPERTY, PLANT, AND EQUIPMENT (Tables) | 3 Months Ended | |||||||
Mar. 31, 2014 | ||||||||
Property, Plant and Equipment [Abstract] | ' | |||||||
Property, Plant and Equipment | ' | |||||||
Property, plant, and equipment consist of the following as of: | ||||||||
(in thousands) | March 31, | December 31, | ||||||
2014 | 2013 | |||||||
Land | $ | 87 | $ | 87 | ||||
Buildings | 3,682 | 3,682 | ||||||
Machinery, furniture and equipment | 4,017 | 3,736 | ||||||
Construction in progress | 66 | 229 | ||||||
7,852 | 7,734 | |||||||
Less: accumulated depreciation | -3,334 | -3,197 | ||||||
Property, Plant and Equipment, net | $ | 4,518 | $ | 4,537 | ||||
GOODWILL_AND_INTANGIBLE_ASSETS1
GOODWILL AND INTANGIBLE ASSETS (Tables) | 3 Months Ended | |||||||||||||||
Mar. 31, 2014 | ||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ' | |||||||||||||||
Schedule of Intangible Assets and Goodwill | ' | |||||||||||||||
The components of our definite-lived intangible assets are as follows: | ||||||||||||||||
(in thousands) | March 31, 2014 | December 31, 2013 | ||||||||||||||
Gross Carrying | Accumulated | Gross Carrying | Accumulated | Amortization | ||||||||||||
Amount | Amortization | Amount | Amortization | Period | ||||||||||||
Acquired ANDA intangible assets | $ | 12,577 | $ | -373 | $ | 60 | $ | -55 | 3-10 years | |||||||
Reglan® intangible asset | 100 | -100 | 100 | -100 | 2 years | |||||||||||
Teva license intangible asset | 10,900 | -744 | 10,900 | -496 | 11 years | |||||||||||
$ | 23,577 | $ | -1,217 | $ | 11,060 | $ | -651 | |||||||||
Finite-lived Intangible Assets Amortization Expense | ' | |||||||||||||||
Expected future amortization expense is as follows: | ||||||||||||||||
(in thousands) | ||||||||||||||||
2014 (remainder of the year) | $ | 1,682 | ||||||||||||||
2015 | 2,243 | |||||||||||||||
2016 | 2,243 | |||||||||||||||
2017 | 2,243 | |||||||||||||||
2018 | 2,243 | |||||||||||||||
2019 and thereafter | 11,706 | |||||||||||||||
Total | $ | 22,360 | ||||||||||||||
FAIR_VALUE_DISCLOSURES_Tables
FAIR VALUE DISCLOSURES (Tables) | 3 Months Ended | |||||||||||||
Mar. 31, 2014 | ||||||||||||||
FAIR VALUE DISCLOSURES | ' | |||||||||||||
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | ' | |||||||||||||
The following table presents our financial assets and liabilities accounted for at fair value on a recurring basis as of March 31, 2014 and December 31, 2013, by level within the fair value hierarchy: | ||||||||||||||
(in thousands) | ||||||||||||||
Description | Fair Value at | Level 1 | Level 2 | Level 3 | ||||||||||
March 31, 2014 | ||||||||||||||
Liabilities | ||||||||||||||
CVRs | $ | - | $ | - | $ | - | $ | - | ||||||
Description | Fair Value at | Level 1 | Level 2 | Level 3 | ||||||||||
31-Dec-13 | ||||||||||||||
Liabilities | ||||||||||||||
CVRs | $ | - | $ | - | $ | - | $ | - | ||||||
REVENUE_RECOGNITION_AND_RELATE2
REVENUE RECOGNITION AND RELATED ALLOWANCES (Details) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | Mar. 31, 2013 |
In Thousands, unless otherwise specified | Chargebacks | Chargebacks | Returns | Returns | Administrative Fees And Other Rebates | Administrative Fees And Other Rebates | Prompt Payment Discounts | Prompt Payment Discounts | ||
Valuation and Qualifying Accounts Disclosure | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Beginning balance | $4,874 | $5,104 | $4,076 | $5,662 | $736 | $411 | $735 | $231 | $332 | $242 |
Accruals/Adjustments | ' | ' | 7,090 | 5,579 | 258 | 120 | 970 | 559 | 347 | 199 |
Credits Taken Against Reserve | ' | ' | -7,357 | -7,903 | -145 | -155 | -853 | -516 | -370 | -244 |
Ending balance | $4,874 | $5,104 | $3,809 | $3,338 | $849 | $376 | $852 | $274 | $309 | $197 |
REVENUE_RECOGNITION_AND_RELATE3
REVENUE RECOGNITION AND RELATED ALLOWANCES (Details 2) (USD $) | 3 Months Ended | |
In Millions, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Accounts Receivable, Related Parties | 8 | ' |
Customer One [Member] | ' | ' |
Concentration Risk, Percentage | 23.00% | 26.00% |
Customer Two [Member] | ' | ' |
Concentration Risk, Percentage | 18.00% | 17.00% |
Customer Three [Member] | ' | ' |
Concentration Risk, Percentage | 15.00% | 14.00% |
BUSINESS_COMBINATION_Details
BUSINESS COMBINATION (Details) (USD $) | Mar. 31, 2014 |
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_1
BUSINESS COMBINATION (Details 1) (USD $) | Jun. 19, 2013 |
In Thousands, unless otherwise specified | |
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 | 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 | $29,795 |
BUSINESS_COMBINATION_Details_2
BUSINESS COMBINATION (Details 2) (USD $) | 3 Months Ended |
In Thousands, unless otherwise specified | Mar. 31, 2013 |
Net revenues | $5,707 |
Net loss | ($1,601) |
BUSINESS_COMBINATION_Details_3
BUSINESS COMBINATION (Details 3) (USD $) | 3 Months Ended | 24 Months Ended | ||
In Millions, except Per Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | Jun. 19, 2013 |
Share Price | ' | ' | ' | $1.22 |
Finite-Lived Intangible Asset, Useful Life | '10 years | ' | ' | ' |
Business Combination Deferred Tax Assets Established Gross | ' | ' | ' | $9.60 |
Business Combination Deferred Tax Liabilities Established Gross | ' | ' | ' | 3.9 |
Valuation allowance | ' | ' | ' | 5.7 |
Business Combination, Acquisition Related Costs | ' | $0.10 | $7.10 | ' |
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% |
ANIP Acquisition Company [Member] | ' | ' | ' | ' |
Business Acquisition, Percentage of Voting Interests Acquired | ' | ' | ' | 57.00% |
EARNINGSLOSS_PER_SHARE_Details
EARNINGS/(LOSS) PER SHARE (Details) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Net income, Basic | $3,359 | $260 |
Net income allocated to common shares, Basic | 3,325 | ' |
Net income, Diluted | 3,359 | ' |
Net income allocated to common shares, Diluted | 3,325 | ' |
Warrant [Member] | ' | ' |
Net income allocated to warrants, Basic | -19 | ' |
Net income allocated to warrants, Diluted | -19 | ' |
Restricted Stock [Member] | ' | ' |
Net income allocated to warrants, Basic | -15 | ' |
Net income allocated to warrants, Diluted | ($15) | ' |
EARNINGSLOSS_PER_SHARE_Details1
EARNINGS/(LOSS) PER SHARE (Details 2) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 700,000 | 4,900,000 |
Class of Warrant or Right, Outstanding | 555,000 | ' |
Restricted Stock [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number, Beginning Balance | 50,000 | ' |
Common Stock [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | 90,000 | ' |
INVENTORIES_Details
INVENTORIES (Details) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventories | ' | ' |
Raw materials | $3,483 | $1,480 |
Packaging materials | 732 | 766 |
Work-in-progress | 200 | 162 |
Finished goods | 709 | 1,152 |
Inventory, Gross, Total | 5,124 | 3,560 |
Reserve for excess/obsolete inventories | -34 | -42 |
Inventories, net | $5,090 | $3,518 |
INVENTORIES_Details_1
INVENTORIES (Details 1) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Two Suppliers [Member] | Three Suppliers [Member] | |
Concentration Risk, Percentage | 49.00% | 43.00% |
PROPERTY_PLANT_AND_EQUIPMENT_D
PROPERTY, PLANT, AND EQUIPMENT (Details) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment, Gross, Total | $7,852 | $7,734 |
Less: accumulated depreciation | -3,334 | -3,197 |
Property, plant, and equipment, net | 4,518 | 4,537 |
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 | 4,017 | 3,736 |
Construction in Progress [Member] | ' | ' |
Property, Plant and Equipment, Gross, Total | $66 | $229 |
PROPERTY_PLANT_AND_EQUIPMENT_D1
PROPERTY, PLANT, AND EQUIPMENT (Details 2) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Depreciation, Total | $137 | $132 |
GOODWILL_AND_INTANGIBLE_ASSETS2
GOODWILL AND INTANGIBLE ASSETS (Details) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Dec. 31, 2013 |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
Finite-Lived Intangible Assets, Gross | $23,577 | $11,060 |
Finite-Lived Intangible Assets, Accumulated Amortization | -1,217 | -651 |
Amortization period | '10 years | ' |
Acquired ANDA Intangible Asset | ' | ' |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
Finite-Lived Intangible Assets, Gross | 12,577 | 60 |
Finite-Lived Intangible Assets, Accumulated Amortization | -373 | -55 |
Acquired ANDA Intangible Asset | Maximum [Member] | ' | ' |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
Amortization period | '10 years | ' |
Acquired ANDA Intangible Asset | Minimum [Member] | ' | ' |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
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 | -100 |
Amortization period | '2 years | ' |
Teva License Intangible Asset | ' | ' |
GOODWILL AND INTANGIBLE ASSETS | ' | ' |
Finite-Lived Intangible Assets, Gross | 10,900 | 10,900 |
Finite-Lived Intangible Assets, Accumulated Amortization | ($744) | ($496) |
Amortization period | '11 years | ' |
GOODWILL_AND_INTANGIBLE_ASSETS3
GOODWILL AND INTANGIBLE ASSETS (Details 1) (USD $) | Mar. 31, 2014 |
In Thousands, unless otherwise specified | |
GOODWILL AND INTANGIBLE ASSETS | ' |
2014 (remainder of the year) | $1,682 |
2015 | 2,243 |
2016 | 2,243 |
2017 | 2,243 |
2018 | 2,243 |
2019 and thereafter | 11,706 |
Total | $22,360 |
GOODWILL_AND_INTANGIBLE_ASSETS4
GOODWILL AND INTANGIBLE ASSETS (Details 2) (USD $) | 1 Months Ended | 3 Months Ended | ||||
Mar. 31, 2014 | Jan. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2014 | Jun. 30, 2013 | Mar. 31, 2013 | |
GOODWILL AND INTANGIBLE ASSETS | ' | ' | ' | ' | ' | ' |
Amortization of Intangible Assets | ' | ' | ' | $600,000 | ' | $13,000 |
Goodwill, Acquired During Period | ' | ' | ' | ' | 1,800,000 | ' |
Intangible Asset Purchase Agreement Quantity Acquired | ' | ' | ' | 31 | ' | ' |
Intangible Asset Purchase Type Of Products | ' | ' | 'generic drug products | ' | ' | ' |
Intangible Asset Purchase Agreement, Amount | ' | ' | 12,500,000 | ' | ' | ' |
Intangible Asset Purchase Agreement Payment | $4,000,000 | $8,500,000 | ' | ' | ' | ' |
Intangible Asset Purchase Agreement Number Of Immediate Release Products | ' | ' | ' | 20 | ' | ' |
Finite-Lived Intangible Asset, Useful Life | ' | ' | ' | '10 years | ' | ' |
Intangible Asset Purchase Agreement Number Of Extended Release Products | ' | ' | ' | 4 | ' | ' |
Intangible Asset Purchase Agreement Number Of Liquid Products | ' | ' | ' | 7 | ' | ' |
STOCKBASED_COMPENSATION_Detail
STOCK-BASED COMPENSATION (Details) (USD $) | 0 Months Ended | 3 Months Ended | 0 Months Ended | 1 Months Ended | ||
In Thousands, unless otherwise specified | Apr. 01, 2014 | Mar. 31, 2014 | Apr. 01, 2014 | Jul. 31, 2013 | Nov. 30, 2013 | Mar. 31, 2014 |
Non-Employee Director Stock Option [Member] | Non-Employee Director Stock Option [Member] | Non-employee Director Restricted Stock [Member] | 2008 Plan [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 | ' | ' | ' | ' | ' | 154 |
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 | 59 | ' | 16 | 21 | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | ' | ' | ' | ' | 50 | ' |
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Outstanding Subject To Shareholder Approval Number | 30 | ' | ' | ' | ' | ' |
Stock-based compensation expense | ' | $47 | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | ' | 30 | ' | ' | ' | ' |
STOCKHOLDERS_EQUITY_Details
STOCKHOLDER'S EQUITY (Details) (USD $) | 1 Months Ended | 3 Months Ended | |
Jan. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2013 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | 9 | ' | ' |
Stock Issued During Period Due To Warrant Exercise Number | 20,000 | ' | ' |
Class Of Warrant Or Right Number Of Securities Called By Warrants That Expired During Period Number | 112,000 | ' | ' |
Stock Issued During Period, Shares, New Issues | ' | 1,600,000 | ' |
Shares Issued, Price Per Share | ' | $31 | ' |
Proceeds from Issuance of Common Stock | ' | $50,000,000 | ' |
Proceeds from Issuance of Common Stock, Net | ' | 46,694,000 | 0 |
Payments of Stock Issuance Costs | ' | $3,300,000 | ' |
Stock Issued During Period Shares New Issues Due to Exercise of Option to Purchase Additional Shares | ' | 200,000 | ' |
INCOME_TAXES_Details
INCOME TAXES (Details) | 3 Months Ended |
Mar. 31, 2014 | |
Effective Income Tax Rate Reconciliation, Percent, Total | 4.60% |
COMMITMENTS_AND_CONTINGENCIES_
COMMITMENTS AND CONTINGENCIES (Details) (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
COMMITMENTS AND CONTINGENCIES | ' | ' |
Operating Leases, Future Minimum Payments Due, Total | $261,000 | ' |
Operating Leases, Rent Expense | 17,000 | 5,000 |
Unapproved Generic Products | ' | ' |
COMMITMENTS AND CONTINGENCIES | ' | ' |
Revenue, Net | 6,700,000 | 1,500,000 |
Unapproved Generic Products | Contract Customer | ' | ' |
COMMITMENTS AND CONTINGENCIES | ' | ' |
Revenue, Net | 400,000 | 500,000 |
Royalty Revenue, Total | $100,000 | $100,000 |
FAIR_VALUE_DISCLOSURES_Details
FAIR VALUE DISCLOSURES (Details) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Liabilities | ' | ' |
CVRs | $0 | $0 |
Fair Value, Inputs, Level 1 [Member] | ' | ' |
Liabilities | ' | ' |
CVRs | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ' | ' |
Liabilities | ' | ' |
CVRs | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ' | ' |
Liabilities | ' | ' |
CVRs | $0 | $0 |
FAIR_VALUE_DISCLOSURES_Details1
FAIR VALUE DISCLOSURES (Details 2) | 3 Months Ended |
Mar. 31, 2014 | |
Fair Value Inputs, Assets, Quantitative Information | ' |
Fair Value Inputs, Discount Rate | 15.00% |
SUBSEQUENT_EVENTS_Details
SUBSEQUENT EVENTS (Details) (Sofgen Agreement [Member]) | 3 Months Ended |
Mar. 31, 2014 | |
Sofgen Agreement [Member] | ' |
Long-term Purchase Commitment, Description | 'The April 2014 Sofgen Agreement has an initial term of ten years from the launch of the product, which term will automatically renew for two year terms until either party terminates the agreement. |