Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Jun. 30, 2016 | Aug. 03, 2016 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | ELITE PHARMACEUTICALS INC /NV/ | |
Entity Central Index Key | 1,053,369 | |
Current Fiscal Year End Date | --03-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | ELTP | |
Entity Common Stock, Shares Outstanding | 733,715,855 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 |
Current assets: | ||
Cash | $ 12,814,951 | $ 11,512,179 |
Accounts receivable | 1,220,245 | 1,530,296 |
Inventory | 3,735,294 | 3,293,729 |
Prepaid expenses and other current assets | 216,407 | 377,752 |
Total current assets | 17,986,897 | 16,713,956 |
Property and equipment, net of accumulated depreciation of $6,898,916 and $6,726,401, respectively | 8,222,527 | 8,110,721 |
Intangible assets, net of accumulated amortization of $-0- | 6,411,974 | 6,411,799 |
Other assets | ||
Restricted cash - debt service for NJEDA bonds | 388,959 | 388,959 |
Security deposits | 48,714 | 48,714 |
Total other assets | 437,673 | 437,673 |
Total assets | 33,059,071 | 31,674,149 |
Current liabilities: | ||
Accounts payable | 1,457,761 | 1,804,429 |
Accrued expenses | 1,397,470 | 555,352 |
Deferred revenue, current portion | 1,013,333 | 1,013,333 |
Bonds payable, current portion (net of bond issuance costs) | 205,822 | 205,822 |
Line of credit, related party | 0 | 718,309 |
Loans payable, current portion | 304,756 | 342,944 |
Total Current Liabilities | 4,379,142 | 4,640,189 |
Long-term liabilities: | ||
Deferred revenue, net of current portion | 3,025,557 | 3,278,887 |
Bonds payable, net of current portion (net of bond issuance costs) | 1,658,322 | 1,654,777 |
Loans payable, net current portion | 450,001 | 520,829 |
Derivative financial instruments - warrants | 7,968,646 | 10,368,567 |
Other long term liabilities | 41,331 | 47,422 |
Total long term liabilities | 13,143,857 | 15,870,482 |
Total liabilities | 17,522,999 | 20,510,671 |
Mezzanine Equity | ||
Series I convertible preferred stock; par value $0.01; 500 shares authorized; 100 shares issued and outstanding as of June 30, 2016 and March 31, 2016 | 46,428,572 | 44,285,715 |
Stockholders' deficit: | ||
Common stock; par value $0.001; 995,000,000 shares authorized; 730,971,084 shares issued and 730,871,084 outstanding as of June 30, 2016; 711,544,352 shares issued and 711,444,352 outstanding as of March 31, 2016 | 730,974 | 711,546 |
Additional paid-in capital | 110,254,090 | 109,137,805 |
Treasury stock; 100,000 shares as of June 30, 2016 and March 31, 2016; at cost | (306,841) | (306,841) |
Accumulated deficit | (141,570,723) | (142,664,747) |
Total stockholders' deficit | (30,892,500) | (33,122,237) |
Total liabilities, mezzanine equity and stockholders' deficit | $ 33,059,071 | $ 31,674,149 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 |
Allowance for doubtful accounts (in dollars) | $ 6,898,916 | $ 6,726,401 |
Finite-Lived Intangible Assets, Accumulated Amortization | $ 0 | $ 0 |
Temporary Equity, Par or Stated Value Per Share | $ 0.01 | $ 0.01 |
Temporary Equity, Shares Authorized | 500 | 500 |
Temporary Equity, Shares Issued | 100 | 100 |
Temporary Equity, Shares Outstanding | 100 | 100 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 995,000,000 | 995,000,000 |
Common stock, shares issued | 730,971,084 | 711,544,352 |
Common stock, shares outstanding | 730,871,084 | 711,444,352 |
Treasury stock, shares | 100,000 | 100,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Manufacturing fees | $ 2,551,858 | $ 1,675,773 |
Licensing fees | 719,288 | 487,332 |
Total revenue | 3,271,146 | 2,163,105 |
Cost of revenue | 2,147,552 | 1,196,968 |
Gross profit | 1,123,594 | 966,137 |
Operating expenses: | ||
Research and development | 1,550,370 | 2,366,262 |
General and administrative | 699,011 | 754,444 |
Non-cash compensation through issuance of stock options | 89,384 | 90,479 |
Depreciation and amortization | 22,392 | 157,915 |
Total operating expenses | 2,361,157 | 3,369,100 |
Loss from operations | (1,237,563) | (2,402,963) |
Other income (expense): | ||
Interest expense and amortization of debt issuance costs | (68,943) | (76,228) |
Change in fair value of derivative instruments | 2,399,921 | 7,214,261 |
Interest Income | 3,109 | 0 |
Other income (expense), net | 2,334,087 | 7,138,033 |
Income from operations before income taxes | 1,096,524 | 4,735,070 |
Income tax Provision | 2,500 | 2,750 |
Net income | 1,094,024 | 4,732,320 |
Change in carrying value of convertible preferred share mezzanine equity | (2,142,857) | 6,428,571 |
Net (loss) income attributable to common stockholders | $ (1,048,833) | $ 11,160,891 |
Basic (loss) income per share attributable to common stockholders | $ 0 | $ 0.02 |
Diluted (loss) income per share attributable to common stockholders | $ 0 | $ 0 |
Basic weighted average common shares outstanding | 722,783,442 | 646,851,543 |
Diluted weighted average common shares outstanding | 722,783,442 | 812,605,460 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' DEFICIT - 3 months ended Jun. 30, 2016 - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] |
Balane at Mar. 31, 2016 | $ (33,122,237) | $ 711,546 | $ 109,137,805 | $ (306,841) | $ (142,664,747) |
Balance (in shares) at Mar. 31, 2016 | 711,544,352 | 100,000 | |||
Net Income | 1,094,024 | 1,094,024 | |||
Change in value of convertible preferred mezzanine equity | (2,142,857) | (2,142,857) | |||
Issuance of common shares pursuant to the exercise of cash warrants | 704,431 | $ 11,271 | 693,160 | ||
Issuance of common shares pursuant to the exercise of cash warrants (in shares) | 11,270,901 | ||||
Issuance of common shares pursuant to the exercise of cash options | $ 4,000 | $ 40 | 3,960 | ||
Issuance of common shares pursuant to the exercise of cash options (in shares) | 40,000 | 40,000 | |||
Common shares issued in payment of employee salaries | $ 10,417 | $ 33 | 10,384 | ||
Common shares issued in payment of employee salaries (in shares) | 32,244 | ||||
Common shares issued as commitment shares pursuant to the Lincoln Park purchase agreement | 38,441 | $ 119 | 38,322 | ||
Common shares issued as commitment shares pursuant to the Lincoln Park purchase agreement (in shares) | 119,110 | ||||
Costs associated with raising capital | (38,441) | (38,441) | |||
Common shares sold pursuant to the Lincoln Park purchase agreement | 2,470,338 | $ 7,965 | 2,462,373 | ||
Common shares sold pursuant to the Lincoln Park purchase agreement (in shares) | 7,964,477 | ||||
Non-cash compensation through the issuance of employee stock options | 89,384 | 89,384 | |||
Balance at Jun. 30, 2016 | $ (30,892,500) | $ 730,974 | $ 110,254,090 | $ (306,841) | $ (141,570,723) |
Balance (in shares) at Jun. 30, 2016 | 730,971,084 | 100,000 |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net Income | $ 1,094,024 | $ 4,732,320 |
Adjustments to reconcile net (loss) income attributable to common stockholders to net cash used in operating activities: | ||
Depreciation and amortization | 176,060 | 161,460 |
Change in fair value of derivative financial instruments - warrants | (2,399,921) | (7,214,261) |
Non-cash compensation accrued | 457,450 | 573,667 |
Non-cash compensation from the issuance of common stock and options | 89,384 | 90,479 |
Non-cash rent expense and lease accretion | (6,087) | (5,099) |
Change in operating assets and liabilities: | ||
Accounts receivable | 310,051 | 397,822 |
Inventory | (441,565) | 168,789 |
Prepaid expenses and other current assets | 161,345 | 148,953 |
Accounts payable, accrued expenses and other current liabilities | 48,417 | (2,076,625) |
Deferred revenue | (253,330) | 4,913,333 |
Net cash (used in) provided by operating activities | (764,172) | 1,890,838 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (284,323) | (709,706) |
Intellectual property costs | (175) | (6,637) |
Net cash used in investing activities | (284,498) | (716,343) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of stock | 2,470,338 | 2,040,591 |
Proceeds from cash warrant and options exercises | 708,431 | 1,199,671 |
Proceeds and repayments of line of credit, related party - net | (718,309) | (171,362) |
Repayments of loans payable and other long term liabilities | (109,018) | (90,938) |
Net cash provided by financing activities | 2,351,442 | 2,977,962 |
Net change in cash | 1,302,772 | 4,152,457 |
Cash, beginning of period | 11,512,179 | 7,464,180 |
Cash, end of period | 12,814,951 | 11,616,637 |
Supplemental disclosure of cash and non-cash transactions: | ||
Cash paid for interest | 31,422 | 22,552 |
Commitment shares issued to Lincoln Park Capital | 38,441 | 849,897 |
Change in carrying value of convertible preferred mezzanine equity | $ (2,142,857) | $ 6,428,571 |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Text Block] | NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Overview Elite Pharmaceuticals, Inc. (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State of Delaware, and its wholly-owned subsidiary Elite Laboratories, Inc. (“Elite Labs”) which was incorporated on August 23, 1990 under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of Nevada. Elite Labs engages primarily in researching, developing and licensing proprietary orally administered, controlled-release drug delivery systems and products with abuse deterrent capabilities and the manufacture of generic, oral dose pharmaceuticals. The Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself if and when the products are approved. These products include drugs that cover therapeutic areas for pain, allergy, bariatric and infection. Research and development activities are done so with an objective of developing products that will secure marketing approvals from the United States Food and Drug Administration (“US-FDA” or “FDA”), and thereafter, commercially exploiting such products. Principles of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Laboratories, Inc. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, which are, in the opinion of management, necessary for a fair presentation of such statements. The results of operations for the three months ended June 30, 2016 are not necessarily indicative of the results that may be expected for the entire year. As disclosed in the Company’s Annual Report on Form 10-K for the year ended March 31, 2016, the Company has restated the consolidated financial statements as of and for the years ended March 31, 2015 and 2014 and unaudited quarterly financial information for the first two quarters in the year ended March 31, 2016 and the first three quarters in the year ended March 31, 2015, to correct prior periods primarily related to (i) an error in accounting treatment for license agreement with Epic, in which the Company determined that revenue relating to a $ 5,000,000 This Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 includes the impact of the restatement on the comparative unaudited consolidated quarterly financial information for the quarter ended June 30, 2015. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s unaudited condensed consolidated financial statements for the period ended June 30, 2015, included in the Company’s amended Form 10-Q, for the period ended June 30, 2015, filed with the SEC on December 30, 2015; and the Company’s audited consolidated financial statements for the year ended March 31, 2016 included in the Company’s Fiscal 2016 Annual Report on Form 10-K, filed with the SEC on June 15, 2016. In addition, the Company’s future Quarterly Reports on Form 10-Q for subsequent quarterly periods during the current fiscal year will reflect the impact of the restatement in the comparative prior quarter and year-to-date periods. Certain reclassifications have been made to the prior period financial statements to conform to the current period financial statement presentation. These reclassifications had no effect on net earnings or cash flows as previously reported. Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 280, Segment Reporting The Company has determined that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Applications (“ANDA”) and products whose marketing approvals were secured via a New Drug Application (“NDA”). ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals. There are currently no intersegment revenues. Asset information by operating segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s condensed unaudited consolidated financial statements. The Company enters into licensing, manufacturing and development agreements, which may include multiple revenue generating activities, including, without limitation, milestones, licensing fees, product sales and services. These multiple elements are assessed in accordance with ASC 605-25, Revenue Recognition Multiple-Element Arrangements An arrangement component is considered to be a separate unit of accounting if the deliverable relating to the component has value to the customer on a standalone basis, and if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in control of the Company. The Company recognizes payments received pursuant to a multiple revenue agreement as revenue, only if the related delivered item(s) have stand-alone value, with the arrangement being accordingly accounted for as a separate unit of accounting. If such delivered item(s) are considered to either not have stand-alone value, the arrangement is accounted for as a single unit of accounting, and the payments received are recognized as revenue over the estimated period of when performance obligations relating to the item(s) will be performed. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it determines the period over which the performance obligations will be performed and revenue will be recognized. If it cannot reasonably estimate the timing and the level of effort to complete its performance obligations under a multiple-element arrangement, revenues are then recognized on a straight-line basis over the period encompassing the expected completion of such obligations, with such period being reassessed at each subsequent reporting period. Arrangement consideration is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price (the relative selling price method). When applying the relative selling price method, the selling price of each deliverable is determined using vendor-specific objective evidence of selling price, if such exists; otherwise, third-part evidence of selling price. If neither vendor-specific objective evidence nor third-party evidence of selling price exists for a deliverable, the Company uses its best estimate of the selling price for that deliverable when applying the relative selling price method. In deciding whether we can determine vendor-specific objective evidence or third-party evidence of selling price, the Company does not ignore information that is reasonably available without undue cost and effort. When determining the selling price for significant deliverables under a multiple-element revenue arrangement, the Company considers any or all of the following, without limitation, depending on information available or information that could be reasonably available without undue cost and effort: vendor-specific objective evidence, third party evidence or best estimate of selling price. More specifically, factors considered can include, without limitation and as appropriate, size of market for specific a product, number of suppliers and other competitive market factors, forecast market shares and gross profits, barriers/time frames to market entry/launch, intellectual property rights and protections, exclusive or non-exclusive arrangements, costs of similar/identical deliverables from third parties, contractual terms, including, without limitation, length of contract, renewal rights, commercial terms, profit allocations, and other commercial, financial, tangible and intangible factors that may be relevant in the valuation of a specific deliverable. Milestone payments are accounted for in accordance with ASC 605-28, Revenue Recognition Milestone Method · It must be either commensurate with the Company's performance in achieving the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the Company's performance to achieve the milestone; and · It relates solely to past performance; and · It is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. Contracts are considered to be collaborative arrangements when they satisfy the following criteria defined in ASC 808, Collaborative Arrangements · The parties to the contract mist actively participate in the joint operating activity; and · The joint operating activity must expose the parties to the possibility of significant risk and rewards, based on whether or not the activity is successful. The Company entered into a sales and distribution licensing agreement with Epic Pharma LLC, dated June 4, 2015 (the “2015 Epic License Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly, in accordance with GAAP. As of June 30, 2016 and March 31, 2016, the Company had $ 388,959 Inventory is recorded at the lower of cost or market on a first-in first-out basis. The Company capitalizes certain costs to acquire intangible assets, if such assets are determined to have a finite useful life they are amortized on a straight-line basis over the estimated useful life. Costs to acquire indefinite lived intangible assets, such as costs related to ANDAs are capitalized accordingly. The Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that indicate impairment may have occurred. A significant amount of judgment is involved in determining if an indicator of impairment has occurred. Such indicators may include, among others and without limitation: a significant decline in the Company’s expected future cash flows; a sustained, significant decline in the Company’s stock price and market capitalization; a significant adverse change in legal factors or in the business climate of the Company’s segments; unanticipated competition; and slower growth rates. As of June 30, 2016, the Company did not identify any indicators of impairment. Occasionally, the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated. If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed consolidated financial statements. Contingencies are inherently unpredictable and the assessments of the value can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. The Company accounts for stock-based compensation in accordance with ASC Topic 718, Compensation-Stock Compensation The Company follows ASC 260, Earnings Per Share For the Three Months Ended June 30, 2016 2015 (As Restated) Numerator Net income (loss) attributable to common shareholders basic $ (1,048,833) $ 11,160,891 Effect of dilutive instruments on net income n/a (13,642,832) Net loss attributable to common stockholders - diluted $ (1,048,833) $ (2,481,941) Denominator Weighted average shares of common stock outstanding - basic 722,783,442 646,851,543 Dilutive effect of stock options, warrants and convertible securities n/a 165,753,917 Weighted average shares of common stock outstanding diluted 722,783,442 812,605,460 Net income (loss) per share Basic $ (0.00) $ 0.02 Diluted $ (0.00) $ (0.00) ASC Topic 820, Fair Value Measurements and Disclosures ASC Topic 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC Topic 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity's own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under ASC Topic 820 are described as follows: · Level 1 Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date. · Level 2 Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability; and inputs that are derived principally from or corroborated by observable market data by correlation or other means. Fair Value Measurement Using Amount at Fair Level 1 Level 2 Level 3 June 30, 2016 Liabilities Derivative financial instruments - warrants $ 7,968,646 $ - $ - $ 7,968,646 March 31, 2016 Liabilities Derivative financial instruments - warrants $ 10,368,567 $ - $ - $ 10,368,567 See Note 12, for specific inputs used in determining fair value. The carrying amounts of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments. Non-Financial Assets that are Measured at Fair Value on a Non-Recurring Basis Non-financial assets such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized. The Company did not record an impairment charge related to these assets in the periods presented. The Company records treasury stock at the cost to acquire it and includes treasury stock as a component of stockholders’ deficit. In April 2015, the FASB issued ASU 2015-3, Simplifying the Presentation of Debt Issuance Costs In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing In May 2016, the FASB issued ASU 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients |
CHANGE IN ACCOUNTING PRINCIPLE
CHANGE IN ACCOUNTING PRINCIPLE | 3 Months Ended |
Jun. 30, 2016 | |
Change in Accounting Estimate [Line Items] | |
Accounting Changes and Error Corrections [Text Block] | NOTE 2. CHANGE IN ACCOUNTING PRINCIPLE As noted in Note 1 Summary of Significant Accounting Policies, the Company adopted the provisions of ASU 2015-03 and has retroactively restated its consolidated balance sheet for the year ended March 31, 2016. During the fiscal year ended March 31, 2016, the Company had accounted for bond offering costs associated with its NJEDA Bonds as an other asset within the Company’s consolidated balance sheet. The following table is a summary of the effect of the reclassification on the consolidated balance sheet as of March 31, 2016: March 31, 2016 As Adjustments Revised Other assets: EDA bond offering costs $ 204,401 $ (204,401) $ - Current liabilities: Current portion of EDA bonds payable $ 220,000 $ (14,178) $ 205,822 Long term liabilities: EDA bonds payable- non-current $ 1,845,000 $ (190,223) $ 1,654,777 |
INVENTORY
INVENTORY | 3 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Inventory Disclosure [Text Block] | NOTE 3. INVENTORY Inventory as of June 30, 2016 and March 31, 2016 consisted of the following: June 30, 2016 March 31, 2016 Finished goods $ 98,829 $ 225,698 Work-in-progress 144,690 222,784 Raw materials 3,491,775 2,845,247 $ 3,735,294 $ 3,293,729 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 3 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment Disclosure [Text Block] | NOTE 4. PROPERTY AND EQUIPMENT, NET June 30, 2016 March 31, 2016 Land, building and improvements $ 6,447,815 $ 6,230,543 Laboratory, manufacturing and warehouse equipment 8,317,834 8,255,286 Office equipment and software 239,135 234,634 Furniture and fixtures 49,804 49,804 Transportation equipment 66,855 66,855 15,121,443 14,837,122 Less: Accumulated depreciation (6,898,916) (6,726,401) $ 8,222,527 $ 8,110,721 Depreciation expense for the three months ended June 30, 2016 and 2015 was $ 172,515 157,915 |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 3 Months Ended |
Jun. 30, 2016 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets Disclosure [Text Block] | NOTE 5. INTANGIBLE ASSETS June 30, 2016 Estimated Gross Useful Carrying Accumulated Net Book Life Amount Additions Amortization Value Patent application costs * $ 364,482 $ 175 $ - $ 364,657 ANDA acquisition costs Indefinite 6,047,317 - - 6,047,317 $ 6,411,799 $ 175 $ - $ 6,411,974 March 31, 2016 Estimated Gross Useful Carrying Accumulated Net Book Life Amount Additions Amortization Value Patent application costs * $ 334,457 $ 30,025 $ - $ 364,482 ANDA acquisition costs Indefinite 6,047,317 - - 6,047,317 $ 6,381,774 $ 30,025 $ - $ 6,411,799 * Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs will begin upon the issuance of marketing authorization by the Food and Drug Administration (“FDA”). Amortization will then be calculated on a straight-line basis through the expiry of the related patent(s). |
NJEDA BONDS
NJEDA BONDS | 3 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Debt Disclosure [Text Block] | NOTE 6. NJEDA BONDS During August 2005, the Company refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the “NJEDA Bonds” and/or “Bonds”). During July 2014, the Company retired all outstanding Series B Notes, at par, along with all accrued interest due and owed. In relation to the Series A Notes, the Company is required to maintain a debt service reserve. The debt serve reserve is classified as restricted cash on the accompanying unaudited condensed consolidated balance sheets. The NJEDA Bonds require the Company to make an annual principal payment on September 1 st st st 6.5 June 30, 2016 March 31, 2016 Gross Bonds payable NJEDA Bonds - Series A Notes $ 2,065,000 $ 2,065,000 Less: Current portion of bonds payable (prior to deduction of bond offering costs) (220,000) (220,000) Long-term portion of bonds payable, (prior to deduction of bond offering costs) $ 1,845,000 $ 1,845,000 Bond Offering Costs $ 354,453 $ 354,453 Less: Accumulated amortization (153,597) (150,052) Bond offering costs, net $ 200,856 $ 204,401 Current portion of bonds payable net of bond offering costs Current portion of bonds payable $ 220,000 $ 220,000 Less: Bond offering costs to be amortized in the next 12 months (14,178) (14,178) Current portion of bonds payable, net of bond offering costs $ 205,822 $ 205,822 Long term portion of bonds payable net of bond offering costs Long term portion of bonds payable $ 1,845,000 $ 1,845,000 Less: Bond offering costs to be amortized subsequent to the next 12 months (186,678) (190,223) Long term portion of bonds payable, net of bond offering costs $ 1,658,322 $ 1,654,777 Amortization expense related to the bond offering costs was $ 3,545 |
LOANS PAYABLE
LOANS PAYABLE | 3 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Long-term Debt [Text Block] | June 30, 2016 March 31, 2016 Equipment and insurance financing loans payable, between 6% and 13% interest and maturing between May 2017 and September 2020 $ 754,757 $ 863,773 Less: Current portion of loans payable (304,756) (342,944) Long-term portion of loans payable $ 450,001 $ 520,829 The interest expense associated with the loans payable for the three months ended June 30, 2016 and 2015 amounted to $ 21,151 21,641 |
LINE OF CREDIT - RELATED PARTY
LINE OF CREDIT - RELATED PARTY | 3 Months Ended |
Jun. 30, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions Lines Of Credit And Notes Payable [Text Block] | NOTE 8. LINE OF CREDIT RELATED PARTY During October 2013, the Company entered into a bridge loan agreement (the “Hakim Loan Agreement”) with Mr. Nasrat Hakim, the Company’s President and CEO. Under the terms of the Hakim Loan Agreement, the Company has the right, at its sole discretion, to a line of credit (“Hakim Credit Line”) in the maximum principal amount of up to $ 1,000,000 March 31, 2016 10 As of March 31, 2016, the principal balance owed under the Hakim Credit Line was $ 718,309 70,784 9,134 |
DEFERRED REVENUE
DEFERRED REVENUE | 3 Months Ended |
Jun. 30, 2016 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue Disclosure [Text Block] | NOTE 9. DEFERRED REVENUE Deferred revenues in the aggregate amount of $4,038,890, consisting of a current component of $1,013,333 and a long term component of $3,025,557. These line items represent the unamortized amounts of a $200,000 advance payment received for a TAGI licensing agreement with a fifteen year term beginning in September 2010 and ending in August 2025 and the $5,000,000 advance payment Epic Collaborative Agreement with a five year term beginning in June 2015 and ending in May 2020. These advance payments were recorded as deferred revenue when received and are earned, on a straight line basis over the life of the licenses. The current component is equal to the amount of revenue to be earned during the 12 month period immediately subsequent to the balance date and the long term component is equal to the amount of revenue to be earned thereafter. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Jun. 30, 2016 | |
Loss Contingency [Abstract] | |
Contingencies Disclosure [Text Block] | NOTE 10. COMMITMENTS AND CONTINGENCIES Occasionally, the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision for a liability when it believes that is both probable that a liability has been incurred, and the amount can be reasonably estimated. If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed consolidated financial statements. Contingencies are inherently unpredictable and the assessments of the value can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. Legal Proceedings Arbitration with Precision Dose, Inc. On May 9, 2014, Precision Dose Inc., the parent company of TAGI Pharmaceuticals, Inc., commenced an arbitration against the Company alleging that the Company failed to properly supply, price and satisfy gross profit minimums regarding Phentermine 37.5mg tablets, as required by the parties’ agreements. Elite denied Precision Dose’s allegations and has counterclaimed that Precision Dose is no longer entitled to exclusivity rights with respect to Phentermine 37.5mg tablets, and is responsible for certain costs, expenses, price increases and lost profits relating to Phentermine 37.5mg tablets and the parties’ agreements. The parties have reached agreement in settlement of these issues, with Precision Dose agreeing to pay certain amounts to the Company in exchange for Elite agreeing to restore exclusivity rights with respect to Phentermine 37.5mg tablets, subject to certain defined conditions. Both parties have been complying with the agreed settlement terms and the Company has notified the Arbitrator of this settlement, requesting the issuance of proceeding termination documents. Due to the agreements reached and adhered to with regards to this issue, the Company has determined that no contingency loss needs to be recorded. Operating Leases 135 Ludlow Ave. The Company entered into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “135 Ludlow Ave. lease”). The 135 Ludlow Ave. lease is for approximately 15,000 35,000 The 135 Ludlow Ave. modified lease, includes an initial term, which expires on December 31, 2016 with two tenant renewal options of five years each, at the sole discretion of the Company. On June 22, 2016, the Company exercised the first of these renewal options, with such option including a term that begins on January 1, 2017 and expires on December 31, 2021. The 135 Ludlow Ave. property required significant leasehold improvements and qualifications, as a prerequisite, for its intended future use. Manufacturing, packaging, warehousing and regulatory activities are currently conducted at this location. Additional renovations and construction to further expand the Company’s manufacturing resources are in progress. Rent expense is recorded on the straight-line basis. Rents paid in excess is recognized as deferred rent. Rent expense under the 135 Ludlow Ave. modified lease for the three month ended June 30, 2016 and 2015 was $ 45,213 45,214 rent as of June 30, 2016 and March 31, 2016 was $ 13,015 19,528 The Company has an obligation for the restoration of its leased facility and the removal or dismantlement of certain property and equipment as a result of its business operation in accordance with ASC 410, Asset Retirement and Environmental Obligations Asset Retirement Obligations 28,316 27,895 |
MEZZANINE EQUITY - SERIES I CON
MEZZANINE EQUITY - SERIES I CONVERTIBLE PREFERRED STOCK | 3 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Preferred Stock [Text Block] | NOTE 11. MEZZANINE EQUITY - SERIES I CONVERTIBLE PREFERRED STOCK On February 6, 2014, the Company created the Series I Convertible Preferred Stock (“Series I Preferred”). A total of 500 shares of Series I Preferred are authorized and as of the current Balance Sheet Date, 100 shares are issued and outstanding, with a stated value of $100,000 and a par value of $0.01. The Certificate of Designations (“COD”) for the Series I Preferred contain the following features: Background ⋅ Conversion feature - the Series I Preferred Shares may be converted, at the option of the Holder, into the Company’s Common Stock at a stated conversion price of $0.07. ⋅ Subsequent dilutive issuances - if the Company issues options at a price below the Conversion Price, then the Conversion Price will be reduced. ⋅ Subsequent dividend issuances - if the Company issues Common Stock in lieu of cash in satisfaction of its dividend obligation on its Series C Certificate, the applicable Conversion Price of the Series I Preferred is adjusted. Management has determined that the Series I Preferred host instrument is more akin to equity than debt and also that the above financial instruments are clearly and closely related to the host instrument, with bifurcation and classification as a derivative liability being not required. Based on Management’s review of the COD, the host instrument, the Series I Preferred Shares, will be classified as mezzanine equity. The above identified embedded financial instruments: Conversion Feature, Subsequent Dilutive Issuances and Subsequent Dividend Issuances will not be bifurcated from the host and are therefore classified as mezzanine equity with the Series I Preferred. The Series I Preferred will be carried at the maximum redemption value, with changes in this value charged to retained earnings or to additional paid-in capital in the absence of retained earnings. Changes in carrying value are also subtracted from net income (loss), (in a manner similar to the treatment of dividends paid on preferred stock), in arriving at net income (loss) available to common stockholders used in the calculation of earnings per share. June 30, 2016 March 31, 2016 Shares authorized 500 500 Shares outstanding 100 100 Par value $ 0.01 $ 0.01 Stated value $ 100,000 $ 100,000 Conversion price $ 0.07 $ 0.07 Common shares to be issued upon redemption 142,857,143 142,857,143 Closing price on valuation date $ 0.33 $ 0.31 Carrying value of Series, I convertible preferred stock $ 46,428,572 $ 44,285,715 For the Three Months Ended June 30, 2016 2015 (As Restated) Change in value of Series I convertible preferred stock $ 2,142,857 $ (6,428,571) |
DERIVATIVE FINANCIAL INSTRUMENT
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS | 3 Months Ended |
Jun. 30, 2016 | |
Derivative Liabilities Warrants Disclosure [Abstract] | |
Derivative Financial Instruments Warrants [Text Block] | NOTE 12 . DERIVATIVE FINANCIAL INSTRUMENTS WARRANTS The Company evaluates and accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments and Hedging Activities The Company issued warrants, with terms of five to seven years, to various corporations and individuals, in connection with the sale of securities, loan agreements and consulting agreements. June 30, 2016 March 31, 2016 Weighted Weighted Warrant Average Average Shares Exercise Price Warrant Shares Exercise Price Balance at beginning of period 41,586,066 $ 0.0625 89,870,034 $ 0.0625 Warrants exercised, forfeited and/or expired, net (11,350,901) (48,283,968) Balance at end of period 30,235,165 $ 0.0625 41,586,066 $ 0.0625 June 30, 2016 March 31, 2016 Fair value of the Company's common stock $ 0.33 $ 0.31 Volatility (based on the Company's historical volatility) 62% - 70% 52% - 81% Exercise price $ 0.0625 $ 0.0625 - 0.25 Estimated life (in years) 0.3 - 1.8 0.2 - 2.1 Risk free interest rate (based on 1-year treasury rate) 0.20% - 0.45% 0.18% - 0.73% The changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the three months ended June 30, 2016 were as follows: Balance as of March 31, 2016 $ 10,368,567 Change in fair value of derivative financial instruments - warrants (2,399,921) Balance as of June 30, 2016 $ 7,968,646 |
STOCKHOLDERS' DEFICIT
STOCKHOLDERS' DEFICIT | 3 Months Ended |
Jun. 30, 2016 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | NOTE 13. STOCKHOLDERS’ DEFICIT Lincoln Park Capital On April 10, 2014, the Company entered into a Purchase Agreement (the “Lincoln Park Purchase Agreement” and/or “Purchase Agreement”) and a Registration Rights Agreement (the “Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to the terms of the Purchase Agreement, Lincoln Park has agreed to purchase from the Company up to $ 40 Upon execution of the Purchase Agreement, the Company issued 1,928,641 1,928,641 The Company, from time to time and at the Company’s sole discretion but no more frequently than every other business day, direct Lincoln Park to purchase (a “Regular Purchase”) up to 500,000 800,000 760,000 0.10 In addition to Regular Purchases, on any business day on which the Company has properly submitted a Regular Purchase notice and the closing sale price is not below $ 0.15 30 97 In the case of both Regular Purchases and Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price. Other than as set forth above, there are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control the timing and amount of any sales of the Company’s common stock to Lincoln Park. The Company’s sales of shares of common stock to Lincoln Park under the Purchase Agreement are limited to no more than the number of shares that would result in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 9.99 The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. Actual sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, without limitation, market conditions, the trading price of the Common Stock and determinations by the Company as to appropriate sources of funding for the Company and its operations. There are no trading volume requirements or restrictions under the Purchase Agreement. Lincoln Park has no right to require any sales by the Company, but is obligated to make purchases from the Company as it directs in accordance with the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of Company shares. The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. Common Stock During the three months ended June 30, 2016, the Company issued the following shares of common stock: Issuance of shares of common stock pursuant to the exercise of warrants and stock options The Company issued 11,310,901 708,431 Issuance of shares of common stock in payment of employee salaries The Company issued 32,244 10,417 Issuance of shares of common stock to Lincoln Park The Company issued 119,110 38,441 7,964,477 2,470,338 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Shareholders' Equity and Share-based Payments [Text Block] | NOTE 14. STOCK-BASED COMPENSATION Part of the compensation paid by the Company to its Directors and employees consists of the issuance of common stock or via the granting of options to purchase common stock. Stock-based Director Compensation The Company’s Director compensation policy was instituted in October 2009 and further revised in January 2016, includes provisions that a portion of Director’s fees are to be paid via the issuance of shares of the Company’s common stock, in lieu of cash, with the valuation of such shares being calculated on quarterly basis and equal to the average closing price of the Company’s common stock. During the three months ended June 30, 2016, the Company did not issue any shares of common stock to its Directors in payment of Director’s fees. During the three months ended June 30, 2016, the Company accrued Directors fees totaling $ 18,361 56,896 As of June 30, 2016, the Company owes its Directors a total of 103,020 33,361 Stock-based Employee Compensation Employment contracts with the Company’s President and Chief Executive Officer, Chief Financial Officer and certain other employees includes provisions for a portion of each employee’s salaries to be paid via the issuance of shares of the Company’s common stock, in lieu of cash, with the valuation of such shares being calculated on a quarterly basis and equal to the average closing price of the Company’s common stock. During the three months ended June 30, 2016, the Company issued 32,244 10,417 During the three months ended June 30, 2016, the Company accrued salaries and fees totaling $ 213,667 661,857 As of June 30, 2016, the Company owes its President and Chief Executive Officer, Chief Financial Officer and certain other employees and consultants, a total of 1,296,397 419,167 Options Under its 2014 Stock Option Plan and prior options plans, the Company may grant stock options to officers, selected employees, as well as members of the Board of Directors and advisory board members. All options have generally been granted at a price equal to or greater than the fair market value of the Company’s Common Stock at the date of the grant. Weighted Average Shares Weighted Remaining Contractual Underlying Average Term Aggregate Intrinsic Options Exercise Price (in years) Value Outstanding at April 1, 2016 7,609,667 $ 0.48 6.5 $ 904,409 Granted - - - - Forfeited and expired - - - - Exercised (40,000) 0.10 Outstanding at June 30, 2016 7,569,667 0.48 6.3 975,699 Exercisable at June 30, 2016 4,453,001 0.54 5.5 683,411 The aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company common stock as of June 30, 2016 and March 31, 2016 of $ 0.33 0.31 |
CONCENTRATIONS AND CREDIT RISK
CONCENTRATIONS AND CREDIT RISK | 3 Months Ended |
Jun. 30, 2016 | |
Risks and Uncertainties [Abstract] | |
Concentration Risk Disclosure [Text Block] | NOTE 15. CONCENTRATIONS AND CREDIT RISK Revenues Five customers accounted for substantially all of the Company’s revenues for the three months ended June 30, 2016 and 2015. Included in these customers for the three months ended June 30, 2016, are three customers that accounted for approximately 45 34 13 47 44 5 Accounts Receivable Four customers accounted for substantially all of the Company’s accounts receivable as of June 30, 2016. Included in these customers are three customers that accounted for approximately 53 32 11 Four customers accounted for substantially all of the Company’s accounts receivable as of March 31, 2016. Included in these customers are three customers that accounted for approximately 54 30 8 Purchasing Four suppliers accounted for more than 80 63 9 6 Seven suppliers accounted for more than 80 42 12 9 |
SEGMENT RESULTS
SEGMENT RESULTS | 3 Months Ended |
Jun. 30, 2016 | |
Segment Reporting [Abstract] | |
Segment Reporting Disclosure [Text Block] | NOTE 16. SEGMENT RESULTS FASB ASC 280-10-50, “Disclosure about Segments of an Enterprise and Related Information” The Company has determined that its reportable segments are Abbreviated New Drug Applications (“ANDA”) for generic products and New Drug Applications (“NDA”) for branded products. The Company identified its reporting segments based on the marketing authorization relating to each and the financial information used by its chief operating decision maker to make decisions regarding the allocation of resources to and the financial performance of the reporting segments Asset information by operating segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s unaudited condensed consolidated financial statements. The following represents selected information for the Company’s reportable segments for the three months ended June 30, 2016 and 2015. For the Three Months Ended June 30, 2016 2015 (As Restated) Revenue by Segment ANDA $ 3,021,146 $ 2,079,772 NDA 250,000 83,333 $ 3,271,146 $ 2,163,105 For the Three Months Ended June 30, 2016 2015 (As Restated) Operating Income (Loss) by Segment ANDA $ 172,921 $ 854,473 NDA (608,677) (2,352,552) $ (435,756) $ (1,498,079) The table below reconciles the Company’s operating income (loss) by segment to income from operations before provision for income taxes as reported in the Company’s unaudited condensed consolidated statements of operations. For the Three Months Ended June 30, 2016 2015 (As Restated) Operating income (loss) by segment $ (435,756) $ (1,498,079) Corporate unallocated costs (462,125) (370,075) Interest revenue 3,109 409 Interest expense (68,943) (76,637) Depreciation and amortization expense (22,392) (157,915) Significant non-cash items (317,290) (376,894) Change in fair value of derivative instruments 2,399,921 7,214,261 Income from operations before income taxes $ 1,096,524 $ 4,735,070 |
COLLABORATIVE AGREEMENT WITH EP
COLLABORATIVE AGREEMENT WITH EPIC PHARMA LLC | 3 Months Ended |
Jun. 30, 2016 | |
Collaborative Arrangement [Abstract] | |
Collaborative Arrangement Disclosure [Text Block] | NOTE 17. COLLABORATIVE AGREEMENT WITH EPIC PHARMA LLC On June 4, 2015, the Company entered into the 2015 Epic License Agreement, which provides for the exclusive right to market, sell and distribute, by Epic Pharma LLC (“Epic”) of SequestOx, an abuse deterrent opioid which employs the Company’s proprietary pharmacological abuse-deterrent technology. Epic will be responsible for payment of product development and pharmacovigilance costs, sales and marketing of SequestOx, and Elite will be responsible for the manufacture of the product. Under the 2015 Epic License Agreement, Epic will pay Elite non-refundable payments totaling $ 15 In June 2015, Elite received non-refundable payments totaling $ 5 In addition, in January 2016, a New Drug Application (“NDA”) for SequestOx was filed, thereby earning the Company a non-refundable $ 2.5 To date, the Company received payments totaling $ 7.5 Please note that on July 15, 2016, the FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the SequestOx NDA is complete and the application is not ready for approval in its present form. The Company currently is evaluating the points raised in the CRL and intends to request an End of Review meeting with the FDA to determine the pathway forward for SequestOx.. There can be no assurances that this product will receive marketing authorization and achieve commercialization within this time period, or at all. In addition, even if marketing authorization is received, there can be no assurances that there will be future revenues of profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments made to secure this marketing authorization. |
RELATED PARTY TRANSACTION AGREE
RELATED PARTY TRANSACTION AGREEMENTS WITH EPIC PHARMA LLC | 3 Months Ended |
Jun. 30, 2016 | |
Epic Pharma Llc [Member] | |
Related Party Transactions Disclosure [Text Block] | NOTE 18. RELATED PARTY TRANSACTION AGREEMENTS WITH EPIC PHARMA LLC The Company has entered into two agreements with Epic which constitute agreements with a related party due to the management of Epic including a member on our Board of Directors at the time such agreements were executed. On June 4, 2015, the Company entered into the 2015 Epic License Agreement (please see Note 18 above) The 2015 Epic License Agreement includes milestone payments totaling $ 10 · The Company’s performance is required to achieve each milestone; and · The milestones will relate to past performance, when achieved; and · The milestones are reasonable relative to all of the deliverables and payment terms within the 2015 Epic License Agreement After marketing authorization is received from the FDA, Elite will receive a license fee which is based on profits achieved from the commercial sales of ELI-200. On January 14, 2016, the Company filed an NDA with the FDA for SequestOx, thereby earning a $ 2.5 7.5 On October 2, 2013, Elite executed the Epic Pharma Manufacturing and License Agreement (the “Epic Generic Agreement”), which granted rights to Epic to manufacture twelve generic products whose ANDA’s are owned by Elite, and to market, in the United States and Puerto Rico, six of these products on an exclusive basis, and the remaining six products on a non-exclusive basis. These products will be manufactured at Epic, with Epic being responsible for the manufacturing site transfer supplements that are a prerequisite to each product being approved for commercial sale. In addition, Epic is responsible for all regulatory and pharmacovigilance matters, as well as all marketing and distribution activities. Elite has no further obligations or deliverables under the Epic Generic Agreement. Pursuant to the Epic Generic Agreement, Elite will receive $ 1.8 1.0 800 Both the 2015 Epic License Agreement and the Epic Generic Agreement contain license fees that will be earned and payable to the Company, after the FDA has issued marketing authorization(s) for the related product(s). License fees are based on commercial sales of the products achieved by Epic and calculated as a percentage of net sales dollars realized from such commercial sales. Net sales dollars consist of gross invoiced sales less those costs and deductions directly attributable to each invoiced sale, including, without limitation, cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price adjustments, returns, short date adjustments, charge backs, promotions and marketing costs. The rate applied to the net sales dollars to determine license fees due to the Company is equal to an amount negotiated and agreed to by the parties to each agreement, with the following significant factors, inputs, assumptions and methods, without limitation, being considered by either or both parties: · Assessment of the opportunity for each product in the market, including consideration of the following, without limitation: market size, number of competitors, the current and estimated future regulatory, legislative and social environment for abuse deterrent opioids and the other generic products to which the underlying contracts are relevant; · Assessment of various avenues for monetizing SequestOx and the twelve ANDA’s owned by the Company, including the various combinations of sites of manufacture and marketing options; · Elite’s resources and capabilities with regards to the concurrent development of abuse deterrent opioids and expansion of its generic business segment, including financial and operational resources required to achieve manufacturing site transfers for twelve approved ANDA’s; · Capabilities of each party with regards to various factors, including, one or more of the following: manufacturing, marketing, regulatory and financial resources, distribution capabilities, ownership structure, personnel, assessments of operational efficiencies and entity stability, company culture and image; · Stage of development of SequestOx and manufacturing site transfer and regulatory requirements relating to the commercialization of the generic products at the time of the discussions/negotiations, and an assessment of the risks, probability and time frames for achieving marketing authorizations from the FDA for each product. · Assessment of consideration offered; and · Comparison of the above factors among the various entities with whom the Company was engaged in discussions relating to the commercialization of SequestOx and the manufacture/marketing of the twelve generics related to the Epic Generic Agreement. This transaction is not to be considered as an arms-length transaction. Please also note that, effective April 7, 2016, all Directors on the Company’s Board of Directors that were also owners/managers of Epic had resigned as Directors of the Company and all current members of the Company’s Board of Directors have no relationship to Epic. Accordingly, Epic no longer qualifies as a party that is related to the Company. |
MANUFACTURING, LICENSE AND DEVE
MANUFACTURING, LICENSE AND DEVELOPMENT AGREEMENTS | 3 Months Ended |
Jun. 30, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transaction, Manufacturing And License Agreement Disclosure [Text Block] | NOTE 19. MANUFACTURING, LICENSE AND DEVELOPMENT AGREEMENTS The Company has entered into the following active agreements: · License agreement with Precision Dose, dated September 10, 2010 (the “Precision Dose License Agreement”) · Manufacturing and Supply Agreement with Ascend Laboratories Inc., dated June 23, 2011 and as amended on September 24, 2012 and January 19, 2015 (the “Ascend Manufacturing Agreement”) and · Development agreement with Akorn Pharmaceuticals, dated January 10, 2011 (the “Akorn Agreement”). The Precision Dose Agreement provides for the marketing and distribution, by Precision Dose and its wholly owned subsidiary, TAGI Pharma, of Phentermine 37.5mg tablets (launched in April 2011), Phentermine 15mg capsules (launched in April 2013), Phentermine 30mg capsules (launched in April 2013), Hydromorphone 8mg tablets (launched in March 2012), Naltrexone 50mg tablets (launched in September 2013) and certain additional products that require approval from the FDA which has not been received. Precision Dose will have the exclusive right to market these products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada. Pursuant to the Precision Dose License Agreement, Elite received $200k at signing, and is receiving milestone payments and a license fee which is based on profits achieved from the commercial sale of the products included in the agreement. Revenue from the $ 200 The milestones, totaling $500k (with $405k already received), consist of amounts due upon the first shipment of each identified product, as follows: Phentermine 37.5mg tablets ($145k), Phentermine 15 & 30mg capsules ($45k), Hydromorphone 8mg ($125k), Naltrexone 50mg ($95k) and the balance of $95k due in relation to the first shipment of generic products which still require marketing authorizations from the FDA, and to which there can be no assurances of such marketing authorizations being granted and accordingly there can be no assurances that the Company will earn and receive these milestone amounts. These milestones have been determined to be substantive, with such determination being made by the Company after assessments based on the following: · The Company’s performance is required to achieve each milestone; and · The milestones will relate to past performance, when achieved; and · The milestones are reasonable relative to all of the deliverables and payment terms within the Precision Dose License Agreement. The license fees provided for in the Precision Dose Agreement are calculated as a percentage of net sales dollars realized from commercial sales of the related products. Net sales dollars consist of gross invoiced sales less those costs and deductions directly attributable to each invoiced sale, including, without limitation, cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price adjustments, returns, short date adjustments, charge backs, promotions and marketing costs. The rate applied to the net sales dollars to determine license fees due to the Company is equal to an amount negotiated and agreed to by the parties to the Precision Dose License Agreement, with the following significant factors, inputs, assumptions and methods, without limitation, being considered by either or both parties: · Assessment of the opportunity for each generic product in the market, including consideration of the following, without limitation: market size, number of competitors, the current and estimated future regulatory, legislative and social environment for each generic product, and the maturity of the market; · Assessment of various avenues for monetizing the generic products, including the various combinations of sites of manufacture and marketing options; · Capabilities of each party with regards to various factors, including, one or more of the following: manufacturing resources, marketing resources, financial resources, distribution capabilities, ownership structure, personnel, assessment of operational efficiencies and stability, company culture and image; · Stage of development of each generic products, all of which did not have FDA approval at the time of the discussions/negotiations and an assessment of the risks, probability and time frame for achieving marketing authorizations from the FDA for the products; · Assessment of consideration offered by Precision and other entities with whom discussions were conducted; and · Comparison of the above factors among the various entities with whom the Company was engaged in discussions relating to the commercialization of the generic products. The Ascend Manufacturing Agreement provides for the manufacturing by Elite of Methadone 10mg for supply to Ascend Laboratories LLC (“Ascend”). Ascend is the owner of the approved ANDA for Methadone 10mg, and the Northvale Facility is an approved manufacturing site for this ANDA. There are no license fees or milestones relating to this agreement. All revenues earned are recognized as manufacturing revenues on the date of shipment of the product, when title for the goods is transferred, and for which the price is agreed to and it has been determined that collectability is reasonably assured. The initial shipment of Methadone 10mg pursuant to the Ascend Manufacturing Agreement occurred in January 2012. The Akorn Agreement was executed on January 10, 2011 between Hi-Tech Pharmacal Inc. (subsequently acquired by Akorn Pharmaceuticals) and provides for Elite to develop an intermediate product which will be incorporated into the finished formulation of a generic version of a prescription product for Akorn Pharmaceuticals (“Akorn”). There is currently no development activity being conducted pursuant to this agreement and there was no activity during the last fiscal year as well. There can be no assurances that development activities will resume or that a resumption of development activities will result in the successful development of the relevant product. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Jun. 30, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | NOTE 20. SUBSEQUENT EVENTS The Company has evaluated subsequent events from the balance sheet date through August 9, 2016, the date the accompanying financial statements were issued. The following are material subsequent events: FDA Issues Complete Response Letter relating to SequestOX On July 15, 2016, the Company announced that the U.S. Food and Drug Administration (the “FDA”) has issued a Complete Response Letter (the “CRL”) regarding the New Drug Application (the “NDA”) for SequestOX (oxycodone hydrochloride and naltrexone hydrochloride), Elite’s investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The FDA issues CRLs when the Agency considers the review cycle for an application is complete and whether the application is ready for approval in its present form. CRLs often include guidance that describes deficiencies that the FDA has identified in the application. When possible, the FDA recommends actions that the applicant may take to place the application in condition for approval. The CRL determined that the NDA was not ready for approval in its present form. Common Stock sold pursuant to the Lincoln Park Purchase Agreement Subsequent to June 30, 2016 and up to August 3, 2016 (the latest practicable date), a total of 2.71 0.03 0.7 Filing of ANDA for a generic version of Percocet® On August 9, 2016, the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve moderate to severe pain. |
SUMMARY OF SIGNIFICANT ACCOUN27
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Laboratories, Inc. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, which are, in the opinion of management, necessary for a fair presentation of such statements. The results of operations for the three months ended June 30, 2016 are not necessarily indicative of the results that may be expected for the entire year. |
Restatements of Financial Statements [Policy Text Block] | Restatement of Previously Issued Consolidated Financial Statements As disclosed in the Company’s Annual Report on Form 10-K for the year ended March 31, 2016, the Company has restated the consolidated financial statements as of and for the years ended March 31, 2015 and 2014 and unaudited quarterly financial information for the first two quarters in the year ended March 31, 2016 and the first three quarters in the year ended March 31, 2015, to correct prior periods primarily related to (i) an error in accounting treatment for license agreement with Epic, in which the Company determined that revenue relating to a $ 5,000,000 This Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 includes the impact of the restatement on the comparative unaudited consolidated quarterly financial information for the quarter ended June 30, 2015. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s unaudited condensed consolidated financial statements for the period ended June 30, 2015, included in the Company’s amended Form 10-Q, for the period ended June 30, 2015, filed with the SEC on December 30, 2015; and the Company’s audited consolidated financial statements for the year ended March 31, 2016 included in the Company’s Fiscal 2016 Annual Report on Form 10-K, filed with the SEC on June 15, 2016. In addition, the Company’s future Quarterly Reports on Form 10-Q for subsequent quarterly periods during the current fiscal year will reflect the impact of the restatement in the comparative prior quarter and year-to-date periods. |
Reclassification, Policy [Policy Text Block] | Reclassifications Certain reclassifications have been made to the prior period financial statements to conform to the current period financial statement presentation. These reclassifications had no effect on net earnings or cash flows as previously reported. |
Segment Reporting, Policy [Policy Text Block] | Segment Information Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 280, Segment Reporting The Company has determined that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Applications (“ANDA”) and products whose marketing approvals were secured via a New Drug Application (“NDA”). ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals. There are currently no intersegment revenues. Asset information by operating segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s condensed unaudited consolidated financial statements. |
Revenue Recognition, Policy [Policy Text Block] | Revenue Recognition The Company enters into licensing, manufacturing and development agreements, which may include multiple revenue generating activities, including, without limitation, milestones, licensing fees, product sales and services. These multiple elements are assessed in accordance with ASC 605-25, Revenue Recognition Multiple-Element Arrangements An arrangement component is considered to be a separate unit of accounting if the deliverable relating to the component has value to the customer on a standalone basis, and if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in control of the Company. The Company recognizes payments received pursuant to a multiple revenue agreement as revenue, only if the related delivered item(s) have stand-alone value, with the arrangement being accordingly accounted for as a separate unit of accounting. If such delivered item(s) are considered to either not have stand-alone value, the arrangement is accounted for as a single unit of accounting, and the payments received are recognized as revenue over the estimated period of when performance obligations relating to the item(s) will be performed. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it determines the period over which the performance obligations will be performed and revenue will be recognized. If it cannot reasonably estimate the timing and the level of effort to complete its performance obligations under a multiple-element arrangement, revenues are then recognized on a straight-line basis over the period encompassing the expected completion of such obligations, with such period being reassessed at each subsequent reporting period. Arrangement consideration is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price (the relative selling price method). When applying the relative selling price method, the selling price of each deliverable is determined using vendor-specific objective evidence of selling price, if such exists; otherwise, third-part evidence of selling price. If neither vendor-specific objective evidence nor third-party evidence of selling price exists for a deliverable, the Company uses its best estimate of the selling price for that deliverable when applying the relative selling price method. In deciding whether we can determine vendor-specific objective evidence or third-party evidence of selling price, the Company does not ignore information that is reasonably available without undue cost and effort. When determining the selling price for significant deliverables under a multiple-element revenue arrangement, the Company considers any or all of the following, without limitation, depending on information available or information that could be reasonably available without undue cost and effort: vendor-specific objective evidence, third party evidence or best estimate of selling price. More specifically, factors considered can include, without limitation and as appropriate, size of market for specific a product, number of suppliers and other competitive market factors, forecast market shares and gross profits, barriers/time frames to market entry/launch, intellectual property rights and protections, exclusive or non-exclusive arrangements, costs of similar/identical deliverables from third parties, contractual terms, including, without limitation, length of contract, renewal rights, commercial terms, profit allocations, and other commercial, financial, tangible and intangible factors that may be relevant in the valuation of a specific deliverable. Milestone payments are accounted for in accordance with ASC 605-28, Revenue Recognition Milestone Method · It must be either commensurate with the Company's performance in achieving the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the Company's performance to achieve the milestone; and · It relates solely to past performance; and · It is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. |
Collaborative Arrangement, Accounting Policy [Policy Text Block] | Collaborative Arrangements Contracts are considered to be collaborative arrangements when they satisfy the following criteria defined in ASC 808, Collaborative Arrangements · The parties to the contract mist actively participate in the joint operating activity; and · The joint operating activity must expose the parties to the possibility of significant risk and rewards, based on whether or not the activity is successful. The Company entered into a sales and distribution licensing agreement with Epic Pharma LLC, dated June 4, 2015 (the “2015 Epic License Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly, in accordance with GAAP. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash As of June 30, 2016 and March 31, 2016, the Company had $ 388,959 |
Inventory, Policy [Policy Text Block] | Inventory Inventory is recorded at the lower of cost or market on a first-in first-out basis. |
Intangible Assets, Finite-Lived, Policy [Policy Text Block] | Intangible Assets The Company capitalizes certain costs to acquire intangible assets, if such assets are determined to have a finite useful life they are amortized on a straight-line basis over the estimated useful life. Costs to acquire indefinite lived intangible assets, such as costs related to ANDAs are capitalized accordingly. The Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that indicate impairment may have occurred. A significant amount of judgment is involved in determining if an indicator of impairment has occurred. Such indicators may include, among others and without limitation: a significant decline in the Company’s expected future cash flows; a sustained, significant decline in the Company’s stock price and market capitalization; a significant adverse change in legal factors or in the business climate of the Company’s segments; unanticipated competition; and slower growth rates. As of June 30, 2016, the Company did not identify any indicators of impairment. |
Commitments And Contingencies [Policy Text Block] | Contingencies Occasionally, the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated. If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed consolidated financial statements. Contingencies are inherently unpredictable and the assessments of the value can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC Topic 718, Compensation-Stock Compensation |
Earnings Per Share, Policy [Policy Text Block] | Earnings (Loss) Per Share Applicable to Common Stockholders The Company follows ASC 260, Earnings Per Share For the Three Months Ended June 30, 2016 2015 (As Restated) Numerator Net income (loss) attributable to common shareholders basic $ (1,048,833) $ 11,160,891 Effect of dilutive instruments on net income n/a (13,642,832) Net loss attributable to common stockholders - diluted $ (1,048,833) $ (2,481,941) Denominator Weighted average shares of common stock outstanding - basic 722,783,442 646,851,543 Dilutive effect of stock options, warrants and convertible securities n/a 165,753,917 Weighted average shares of common stock outstanding diluted 722,783,442 812,605,460 Net income (loss) per share Basic $ (0.00) $ 0.02 Diluted $ (0.00) $ (0.00) |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments ASC Topic 820, Fair Value Measurements and Disclosures ASC Topic 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC Topic 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity's own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under ASC Topic 820 are described as follows: · Level 1 Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date. · Level 2 Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability; and inputs that are derived principally from or corroborated by observable market data by correlation or other means. Fair Value Measurement Using Amount at Fair Level 1 Level 2 Level 3 June 30, 2016 Liabilities Derivative financial instruments - warrants $ 7,968,646 $ - $ - $ 7,968,646 March 31, 2016 Liabilities Derivative financial instruments - warrants $ 10,368,567 $ - $ - $ 10,368,567 See Note 12, for specific inputs used in determining fair value. The carrying amounts of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments. Non-Financial Assets that are Measured at Fair Value on a Non-Recurring Basis Non-financial assets such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized. The Company did not record an impairment charge related to these assets in the periods presented. |
Treasury Stock Policy [Policy Text Block] | Treasury Stock The Company records treasury stock at the cost to acquire it and includes treasury stock as a component of stockholders’ deficit. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued Accounting Pronouncements In April 2015, the FASB issued ASU 2015-3, Simplifying the Presentation of Debt Issuance Costs In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing In May 2016, the FASB issued ASU 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients |
SUMMARY OF SIGNIFICANT ACCOUN28
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | The following is the computation of earnings (loss) per share applicable to common stockholders for the periods indicated: For the Three Months Ended June 30, 2016 2015 (As Restated) Numerator Net income (loss) attributable to common shareholders basic $ (1,048,833) $ 11,160,891 Effect of dilutive instruments on net income n/a (13,642,832) Net loss attributable to common stockholders - diluted $ (1,048,833) $ (2,481,941) Denominator Weighted average shares of common stock outstanding - basic 722,783,442 646,851,543 Dilutive effect of stock options, warrants and convertible securities n/a 165,753,917 Weighted average shares of common stock outstanding diluted 722,783,442 812,605,460 Net income (loss) per share Basic $ (0.00) $ 0.02 Diluted $ (0.00) $ (0.00) |
Schedule of Derivative Liabilities at Fair Value [Table Text Block] | The following table present information about our liabilities measured at fair value on a recurring basis as of June 30, 2016 and March 31, 2016, aggregated by the level in the fair value hierarchy within which those measurements fell: Fair Value Measurement Using Amount at Fair Level 1 Level 2 Level 3 June 30, 2016 Liabilities Derivative financial instruments - warrants $ 7,968,646 $ - $ - $ 7,968,646 March 31, 2016 Liabilities Derivative financial instruments - warrants $ 10,368,567 $ - $ - $ 10,368,567 |
CHANGE IN ACCOUNTING PRINCIPLE
CHANGE IN ACCOUNTING PRINCIPLE (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Change in Accounting Estimate [Line Items] | |
Schedule of Change in Accounting Estimate [Table Text Block] | The following table is a summary of the effect of the reclassification on the consolidated balance sheet as of March 31, 2016: March 31, 2016 As Adjustments Revised Other assets: EDA bond offering costs $ 204,401 $ (204,401) $ - Current liabilities: Current portion of EDA bonds payable $ 220,000 $ (14,178) $ 205,822 Long term liabilities: EDA bonds payable- non-current $ 1,845,000 $ (190,223) $ 1,654,777 |
INVENTORY (Tables)
INVENTORY (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current [Table Text Block] | Inventory as of June 30, 2016 and March 31, 2016 consisted of the following: June 30, 2016 March 31, 2016 Finished goods $ 98,829 $ 225,698 Work-in-progress 144,690 222,784 Raw materials 3,491,775 2,845,247 $ 3,735,294 $ 3,293,729 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment [Table Text Block] | Property and equipment as of June 30, 2016 and March 31, 2016 consisted of the following: June 30, 2016 March 31, 2016 Land, building and improvements $ 6,447,815 $ 6,230,543 Laboratory, manufacturing and warehouse equipment 8,317,834 8,255,286 Office equipment and software 239,135 234,634 Furniture and fixtures 49,804 49,804 Transportation equipment 66,855 66,855 15,121,443 14,837,122 Less: Accumulated depreciation (6,898,916) (6,726,401) $ 8,222,527 $ 8,110,721 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets and Goodwill [Table Text Block] | June 30, 2016 Estimated Gross Useful Carrying Accumulated Net Book Life Amount Additions Amortization Value Patent application costs * $ 364,482 $ 175 $ - $ 364,657 ANDA acquisition costs Indefinite 6,047,317 - - 6,047,317 $ 6,411,799 $ 175 $ - $ 6,411,974 March 31, 2016 Estimated Gross Useful Carrying Accumulated Net Book Life Amount Additions Amortization Value Patent application costs * $ 334,457 $ 30,025 $ - $ 364,482 ANDA acquisition costs Indefinite 6,047,317 - - 6,047,317 $ 6,381,774 $ 30,025 $ - $ 6,411,799 * Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs will begin upon the issuance of marketing authorization by the Food and Drug Administration (“FDA”). Amortization will then be calculated on a straight-line basis through the expiry of the related patent(s). |
NJEDA BONDS (Tables)
NJEDA BONDS (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of Securities Financing Transactions [Table Text Block] | The following tables summarizes the Company’s bonds payable liability as of June 30, 2016 and March 31, 2016, respectively. June 30, 2016 March 31, 2016 Gross Bonds payable NJEDA Bonds - Series A Notes $ 2,065,000 $ 2,065,000 Less: Current portion of bonds payable (prior to deduction of bond offering costs) (220,000) (220,000) Long-term portion of bonds payable, (prior to deduction of bond offering costs) $ 1,845,000 $ 1,845,000 Bond Offering Costs $ 354,453 $ 354,453 Less: Accumulated amortization (153,597) (150,052) Bond offering costs, net $ 200,856 $ 204,401 Current portion of bonds payable net of bond offering costs Current portion of bonds payable $ 220,000 $ 220,000 Less: Bond offering costs to be amortized in the next 12 months (14,178) (14,178) Current portion of bonds payable, net of bond offering costs $ 205,822 $ 205,822 Long term portion of bonds payable net of bond offering costs Long term portion of bonds payable $ 1,845,000 $ 1,845,000 Less: Bond offering costs to be amortized subsequent to the next 12 months (186,678) (190,223) Long term portion of bonds payable, net of bond offering costs $ 1,658,322 $ 1,654,777 |
LOANS PAYABLE (Tables)
LOANS PAYABLE (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments [Table Text Block] | June 30, 2016 March 31, 2016 Equipment and insurance financing loans payable, between 6% and 13% interest and maturing between May 2017 and September 2020 $ 754,757 $ 863,773 Less: Current portion of loans payable (304,756) (342,944) Long-term portion of loans payable $ 450,001 $ 520,829 |
MEZZANINE EQUITY - SERIES I C35
MEZZANINE EQUITY - SERIES I CONVERTIBLE PREFERRED STOCK (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Schedule of Preferred Stock Activity [Table Text Block] | Authorized, issued and outstanding shares, along with carrying value and change in value as of the periods presented are as follows: June 30, 2016 March 31, 2016 Shares authorized 500 500 Shares outstanding 100 100 Par value $ 0.01 $ 0.01 Stated value $ 100,000 $ 100,000 Conversion price $ 0.07 $ 0.07 Common shares to be issued upon redemption 142,857,143 142,857,143 Closing price on valuation date $ 0.33 $ 0.31 Carrying value of Series, I convertible preferred stock $ 46,428,572 $ 44,285,715 For the Three Months Ended June 30, 2016 2015 (As Restated) Change in value of Series I convertible preferred stock $ 2,142,857 $ (6,428,571) |
DERIVATIVE FINANCIAL INSTRUME36
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Derivative Liabilities Warrants Disclosure [Abstract] | |
Schedule Of Warrants Activity [Table Text Block] | A summary of warrant activity is as follows: June 30, 2016 March 31, 2016 Weighted Weighted Warrant Average Average Shares Exercise Price Warrant Shares Exercise Price Balance at beginning of period 41,586,066 $ 0.0625 89,870,034 $ 0.0625 Warrants exercised, forfeited and/or expired, net (11,350,901) (48,283,968) Balance at end of period 30,235,165 $ 0.0625 41,586,066 $ 0.0625 |
Schedule Of Warrants Valuation Assumptions [Table Text Block] | The fair value of the warrants was calculated using the Black-Scholes model and the following assumptions: June 30, 2016 March 31, 2016 Fair value of the Company's common stock $ 0.33 $ 0.31 Volatility (based on the Company's historical volatility) 62% - 70% 52% - 81% Exercise price $ 0.0625 $ 0.0625 - 0.25 Estimated life (in years) 0.3 - 1.8 0.2 - 2.1 Risk free interest rate (based on 1-year treasury rate) 0.20% - 0.45% 0.18% - 0.73% |
Schedule Of Warrants Measurement With Unobservable Inputs Reconciliation Recurring Basis [Table Text Block] | The changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the three months ended June 30, 2016 were as follows: Balance as of March 31, 2016 $ 10,368,567 Change in fair value of derivative financial instruments - warrants (2,399,921) Balance as of June 30, 2016 $ 7,968,646 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block] | Generally, options are granted with a vesting period of up to three years and expire ten years from the date of grant. Weighted Average Shares Weighted Remaining Contractual Underlying Average Term Aggregate Intrinsic Options Exercise Price (in years) Value Outstanding at April 1, 2016 7,609,667 $ 0.48 6.5 $ 904,409 Granted - - - - Forfeited and expired - - - - Exercised (40,000) 0.10 Outstanding at June 30, 2016 7,569,667 0.48 6.3 975,699 Exercisable at June 30, 2016 4,453,001 0.54 5.5 683,411 |
SEGMENT RESULTS (Tables)
SEGMENT RESULTS (Tables) | 3 Months Ended |
Jun. 30, 2016 | |
Segment Reporting [Abstract] | |
Revenue from External Customers by Geographic Areas [Table Text Block] | The following represents selected information for the Company’s reportable segments for the three months ended June 30, 2016 and 2015. For the Three Months Ended June 30, 2016 2015 (As Restated) Revenue by Segment ANDA $ 3,021,146 $ 2,079,772 NDA 250,000 83,333 $ 3,271,146 $ 2,163,105 For the Three Months Ended June 30, 2016 2015 (As Restated) Operating Income (Loss) by Segment ANDA $ 172,921 $ 854,473 NDA (608,677) (2,352,552) $ (435,756) $ (1,498,079) |
Schedule of Segment Reporting Information, by Segment [Table Text Block] | The table below reconciles the Company’s operating income (loss) by segment to income from operations before provision for income taxes as reported in the Company’s unaudited condensed consolidated statements of operations. For the Three Months Ended June 30, 2016 2015 (As Restated) Operating income (loss) by segment $ (435,756) $ (1,498,079) Corporate unallocated costs (462,125) (370,075) Interest revenue 3,109 409 Interest expense (68,943) (76,637) Depreciation and amortization expense (22,392) (157,915) Significant non-cash items (317,290) (376,894) Change in fair value of derivative instruments 2,399,921 7,214,261 Income from operations before income taxes $ 1,096,524 $ 4,735,070 |
SUMMARY OF SIGNIFICANT ACCOUN39
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Numerator | ||
Net income (loss) attributable to common shareholders - basic | $ (1,048,833) | $ 11,160,891 |
Effect of dilutive instruments on net income | (13,642,832) | |
Net loss attributable to common stockholders - diluted | $ (1,048,833) | $ (2,481,941) |
Denominator | ||
Weighted average shares of common stock outstanding - basic (in shares) | 722,783,442 | 646,851,543 |
Dilutive effect of stock options, warrants and convertible securities (in shares) | 165,753,917 | |
Weighted average shares of common stock outstanding - diluted (in shares) | 722,783,442 | 812,605,460 |
Net income (loss) per share | ||
Basic (in dollars per share) | $ 0 | $ 0.02 |
Diluted (in dollars per share) | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN40
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 |
Derivative financial instruments - warrants | $ 7,968,646 | $ 10,368,567 |
Fair Value, Inputs, Level 1 [Member] | ||
Derivative financial instruments - warrants | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Derivative financial instruments - warrants | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Derivative financial instruments - warrants | $ 7,968,646 | $ 10,368,567 |
SUMMARY OF SIGNIFICANT ACCOUN41
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) | 12 Months Ended | ||
Mar. 31, 2015 | Jun. 30, 2016 | Mar. 31, 2016 | |
Revenue Recognition, Milestone Method, Revenue Recognized | $ 5,000,000 | ||
Restricted Cash and Cash Equivalents | $ 388,959 | $ 388,959 |
CHANGE IN ACCOUNTING PRINCIPL42
CHANGE IN ACCOUNTING PRINCIPLE (Details) - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 |
Other assets | ||
EDA bond offering costs | $ 0 | |
Current liabilities: | ||
Current portion of EDA bonds payable | $ 205,822 | 205,822 |
Long term liabilities: | ||
Long term portion, net of current maturities | $ 1,658,322 | 1,654,777 |
Scenario, Previously Reported [Member] | ||
Other assets | ||
EDA bond offering costs | 204,401 | |
Current liabilities: | ||
Current portion of EDA bonds payable | 220,000 | |
Long term liabilities: | ||
Long term portion, net of current maturities | 1,845,000 | |
Restatement Adjustment [Member] | ||
Other assets | ||
EDA bond offering costs | (204,401) | |
Current liabilities: | ||
Current portion of EDA bonds payable | (14,178) | |
Long term liabilities: | ||
Long term portion, net of current maturities | $ (190,223) |
INVENTORY (Details)
INVENTORY (Details) - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 |
Inventory [Line Items] | ||
Finished goods | $ 98,829 | $ 225,698 |
Work-in-progress | 144,690 | 222,784 |
Raw materials | 3,491,775 | 2,845,247 |
Total Inventory | $ 3,735,294 | $ 3,293,729 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details) - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 15,121,443 | $ 14,837,122 |
Less: Accumulated depreciation | (6,898,916) | (6,726,401) |
Property and equipment, net | 8,222,527 | 8,110,721 |
Laboratory Manufacturing and Warehouse Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 8,317,834 | 8,255,286 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 239,135 | 234,634 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 49,804 | 49,804 |
Transportation Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 66,855 | 66,855 |
Land, Buildings and Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 6,447,815 | $ 6,230,543 |
PROPERTY AND EQUIPMENT, NET (45
PROPERTY AND EQUIPMENT, NET (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Depreciation | $ 172,515 | $ 157,915 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Jun. 30, 2016 | Mar. 31, 2016 | ||
Finite-Lived Intangible Assets [Line Items] | |||
Estimated Useful Life | [1] | 0 years | 0 years |
Finite-Lived Intangible Assets and Indefinite, Accumulated Amortization | $ 0 | $ 0 | |
Gross Carrying Amount Total | 6,411,799 | 6,381,774 | |
Additions, Total | 175 | 30,025 | |
Net Book Value, Total | 6,411,974 | 6,411,799 | |
Patent Application Cost [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Patent application costs, Carrying Value Amount | 364,482 | 334,457 | |
Patent application costs, Additions | 175 | 30,025 | |
Finite-Lived Intangible Assets and Indefinite, Accumulated Amortization | 0 | 0 | |
Finite-Lived Intangible Assets and Indefinite, Net Book Value | 364,657 | 364,482 | |
Anda Acquisition Cost [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
ANDA acquisition costs, Gross Carrying Amount | 6,047,317 | 6,047,317 | |
ANDA acquisition costs, Additions | 0 | 0 | |
Finite-Lived Intangible Assets and Indefinite, Accumulated Amortization | 0 | 0 | |
Finite-Lived Intangible Assets and Indefinite, Net Book Value | $ 6,047,317 | $ 6,047,317 | |
[1] | Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs will begin upon the issuance of marketing authorization by the Food and Drug Administration ("FDA"). Amortization will then be calculated on a straight-line basis through the expiry of the related patent(s). |
NJEDA BONDS (Details)
NJEDA BONDS (Details) - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 |
Debt Instrument [Line Items] | ||
Principal Amount On Issue Date | $ 2,065,000 | $ 2,065,000 |
Debt Issuance Costs, Gross | 354,453 | 354,453 |
Accumulated Amortization, Debt Issuance Costs | (153,597) | (150,052) |
Debt Issuance Costs, Net | 200,856 | 204,401 |
Long-term Debt, Gross | 2,065,000 | 2,065,000 |
NJEDA Bonds - Series A Notes Long Term [Member] | ||
Debt Instrument [Line Items] | ||
Principal Amount On Issue Date | 1,845,000 | 1,845,000 |
Long-term Debt, Gross | 1,845,000 | 1,845,000 |
Debt Issuance Costs, Noncurrent, Net | (186,678) | (190,223) |
Long-term Debt | 1,658,322 | 1,654,777 |
NJEDA Bonds - Series A Notes Short Term [Member] | ||
Debt Instrument [Line Items] | ||
Principal Amount On Issue Date | (220,000) | (220,000) |
Debt Issuance Costs, Net | (14,178) | (14,178) |
Long-term Debt, Gross | (220,000) | (220,000) |
Short-term Debt | $ 205,822 | $ 205,822 |
NJEDA BONDS (Details Textual)
NJEDA BONDS (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Series A Note [Member] | ||
Debt Instrument, Interest Rate During Period | 6.50% | |
Njeda Bonds [Member] | ||
Amortization of Debt Issuance Costs | $ 3,545 | $ 3,545 |
LOANS PAYABLE (Details)
LOANS PAYABLE (Details) - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 |
Debt Instrument [Line Items] | ||
Less: Current portion of loans payable | $ (304,756) | $ (342,944) |
Long-term portion of loans payable | 450,001 | 520,829 |
Secured Debt [Member] | ||
Debt Instrument [Line Items] | ||
Equipment and insurance financing loans payable, between 6% and 13% interest and maturing between May 2017 and September 2020 | 754,757 | 863,773 |
Less: Current portion of loans payable | (304,756) | (342,944) |
Long-term portion of loans payable | $ 450,001 | $ 520,829 |
LOANS PAYABLE (Details Textual)
LOANS PAYABLE (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Debt Instrument [Line Items] | ||
Interest Expense, Debt | $ 21,151 | $ 21,641 |
Financing Loans Payable [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Maturity Date, Description | maturing between May 2017 and September 2020 | |
Maximum [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 13.00% | |
Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 6.00% |
LINE OF CREDIT - RELATED PARTY
LINE OF CREDIT - RELATED PARTY (Details Textual) - Hakim Credit Line [Member] - USD ($) | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2013 | Mar. 31, 2016 | Jun. 30, 2016 | |
Related Party Transaction [Line Items] | |||
Line of Credit Facility, Maximum Borrowing Capacity | $ 1,000,000 | ||
Line of Credit Facility, Expiration Date | Mar. 31, 2016 | ||
Line of Credit Facility, Interest Rate at Period End | 10.00% | ||
Debt Instrument, Face Amount | $ 718,309 | ||
Interest Payable, Current | 70,784 | ||
Interest Expense, Related Party | $ 9,134 |
DEFERRED REVENUE (Details Textu
DEFERRED REVENUE (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Mar. 31, 2016 | |
Deferred Revenue Arrangement [Line Items] | ||
Deferred Revenue | $ 4,038,890 | |
Deferred Revenue, Current | 1,013,333 | $ 1,013,333 |
Deferred Revenue, Noncurrent | $ 3,025,557 | $ 3,278,887 |
Licensing Agreements [Member] | ||
Deferred Revenue Arrangement [Line Items] | ||
Finite-Lived Intangible Assets, Amortization Method | straight line basis | |
TAGI licensing agreement [Member] | ||
Deferred Revenue Arrangement [Line Items] | ||
Advance Rent | $ 200,000 | |
Licensing Agreement Terms | fifteen year | |
Epic Collaborative Agreement [Member] | ||
Deferred Revenue Arrangement [Line Items] | ||
Advance Rent | $ 5,000,000 | |
Licensing Agreement Terms | five year |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Textual) | 3 Months Ended | ||||
Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2016USD ($) | Jul. 31, 2014ft² | Jul. 01, 2010ft² | |
Other Noncurrent Liabilities [Member] | |||||
Operating Leases Rental Properties [Line Items] | |||||
Deferred Rent Credit | $ 13,015 | $ 19,528 | |||
Asset Retirement Obligation | 28,316 | $ 27,895 | |||
General and Administrative Expense [Member] | |||||
Operating Leases Rental Properties [Line Items] | |||||
Operating Leases, Rent Expense | $ 45,213 | $ 45,214 | |||
Property Subject to Operating Lease [Member] | Warehouse [Member] | |||||
Operating Leases Rental Properties [Line Items] | |||||
Area of Land | ft² | 15,000 | ||||
July 2014 Modification Agreement [Member] | Property Subject to Operating Lease [Member] | Warehouse [Member] | |||||
Operating Leases Rental Properties [Line Items] | |||||
Area of Land | ft² | 35,000 |
MEZZANINE EQUITY - SERIES I C54
MEZZANINE EQUITY - SERIES I CONVERTIBLE PREFERRED STOCK (Details) - Series I Convertible Preferred Stock [Member] - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 | Feb. 06, 2014 |
Shares authorized | 500 | 500 | 500 |
Shares outstanding | 100 | 100 | 100 |
Par value | $ 0.01 | $ 0.01 | $ 0.01 |
Stated value | $ 100,000 | $ 100,000 | $ 100,000 |
Conversion price | $ 0.07 | $ 0.07 | $ 0.07 |
Common shares to be issued upon redemption | 142,857,143 | 142,857,143 | |
Closing price on valuation date | $ 0.33 | $ 0.31 | |
Carrying value of Series, I convertible preferred stock | $ 46,428,572 | $ 44,285,715 |
MEZZANINE EQUITY - SERIES I C55
MEZZANINE EQUITY - SERIES I CONVERTIBLE PREFERRED STOCK (Details 1) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Series I Convertible Preferred Stock [Member] | ||
Change in value of Series I convertible preferred stock | $ 2,142,857 | $ (6,428,571) |
MEZZANINE EQUITY - SERIES I C56
MEZZANINE EQUITY - SERIES I CONVERTIBLE PREFERRED STOCK (Details Textual) - Series I Convertible Preferred Stock [Member] - USD ($) | Jun. 30, 2016 | Mar. 31, 2016 | Feb. 06, 2014 |
Preferred Stock, Shares Authorized | 500 | 500 | 500 |
Preferred Stock, Shares Issued | 100 | ||
Preferred Stock, Shares Outstanding | 100 | 100 | 100 |
Convertible Preferred Stock Par Value Per Share | $ 0.01 | $ 0.01 | $ 0.01 |
Convertible Preferred Stock Stated Value | $ 100,000 | $ 100,000 | $ 100,000 |
Preferred Stock Conversion Price Per Share | $ 0.07 | $ 0.07 | $ 0.07 |
DERIVATIVE FINANCIAL INSTRUME57
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Mar. 31, 2016 | |
Class of Warrant or Right [Line Items] | ||
Warrant Shares, Balance at beginning of period | 41,586,066 | 89,870,034 |
Warrant Shares, Warrants exercised, forfeited and/or expired, net | (11,350,901) | (48,283,968) |
Warrant Shares, Balance at end of period | 30,235,165 | 41,586,066 |
Weighted Average Exercise Price, Balance at beginning of year | $ 0.0625 | $ 0.0625 |
Weighted Average Exercise Price, Warrants exercised, forfeited and/or expired, net | ||
Weighted Average Exercise Price, Ending Balance | $ 0.0625 | $ 0.0625 |
DERIVATIVE FINANCIAL INSTRUME58
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS (Details 1) - $ / shares | 3 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Mar. 31, 2016 | |
Minimum [Member] | ||
Class of Warrant or Right [Line Items] | ||
Fair value of the Company's common stock | $ 0.15 | |
Warrant [Member] | ||
Class of Warrant or Right [Line Items] | ||
Fair value of the Company's common stock | 0.33 | $ 0.31 |
Exercise price | $ 0.0625 | |
Warrant [Member] | Minimum [Member] | ||
Class of Warrant or Right [Line Items] | ||
Volatility (based on the Company's historical volatility) | 62.00% | 52.00% |
Exercise price | $ 0.0625 | |
Estimated life (in years) | 3 months 18 days | 2 months 12 days |
Risk free interest rate (based on 1-year treasury rate) | 0.20% | 0.20% |
Warrant [Member] | Maximum [Member] | ||
Class of Warrant or Right [Line Items] | ||
Volatility (based on the Company's historical volatility) | 70.00% | 81.00% |
Exercise price | $ 0.25 | |
Estimated life (in years) | 1 year 9 months 18 days | 2 years 1 month 6 days |
Risk free interest rate (based on 1-year treasury rate) | 0.45% | 0.73% |
DERIVATIVE FINANCIAL INSTRUME59
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS (Details 2) | 3 Months Ended |
Jun. 30, 2016USD ($) | |
Class of Warrant or Right [Line Items] | |
Balance as of March 31, 2016 | $ 10,368,567 |
Change in fair value of derivative financial instruments - warrants | (2,399,921) |
Balance as of June 30, 2016 | $ 7,968,646 |
STOCKHOLDERS' DEFICIT (Details
STOCKHOLDERS' DEFICIT (Details Textual) - USD ($) | Apr. 10, 2014 | Jun. 30, 2016 |
Class of Stock [Line Items] | ||
Stock Issued During Period, Value, New Issues | $ 2,470,338 | |
Common Stock Traded Percent | 30.00% | |
Common Stock Weighted Average Price Percent | 97.00% | |
Stock Issued During Period Value Payment Of Employee Salaries | $ 10,417 | |
Park Capital Purchase Agreement | 38,441 | |
Lincoln Park [Member] | ||
Class of Stock [Line Items] | ||
Stock Issued During Period, Value, New Issues | $ 2,470,338 | |
Stock Issued During Period, Shares, New Issues | 7,964,477 | |
Stock Issued During Period Value Payment Of Employee Salaries | $ 10,417 | |
Park Capital Purchase Agreement Shares | 119,110 | |
Park Capital Purchase Agreement | $ 38,441 | |
Employee Stock Option [Member] | ||
Class of Stock [Line Items] | ||
Stock Issued During Period, Shares, Warrants And Stock Options Exercised | 11,310,901 | |
Stock Issued During Period, Value, Warrants And Stock Options Exercised | $ 708,431 | |
Stock Issued During Period Shares Payment Of Employee Salaries | 32,244 | |
Minimum [Member] | ||
Class of Stock [Line Items] | ||
Share Price | $ 0.15 | |
Lincoln Park Capital Fund, LLC [Member] | ||
Class of Stock [Line Items] | ||
Common Stock Shares Issued During Period | 40,000,000 | 1,928,641 |
Common Stock Additional Shares To Be Issued During Period | 1,928,641 | |
Maximum Common Stock Shares Directed to Purchase | 500,000 | |
Purchase of Common Stock Increasing Shares Per Purchase | 800,000 | |
Maximum Common Stock Value Directed to Purchase | $ 760,000 | |
Common Stock Floor Price Per Share | $ 0.10 | |
Maximum Percentage to Purchase Common Stock Shares | 9.99% |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Mar. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options, Outstanding at April 1, 2016 | 7,609,667 | |
Options, Granted | 0 | |
Options, Forfeited and expired | 0 | |
Options, Exercised | (40,000) | |
Options, Outstanding at June 30, 2016 | 7,569,667 | 7,609,667 |
Options, Exercisable at June 30, 2016 | 4,453,001 | |
Weighted Average Exercise Price, Outstanding at April 1, 2016 | $ 0.48 | |
Weighted Average Exercise Price, Options Granted | 0 | |
Weighted Average Exercise Price, Options Forfeited and expired | 0 | |
Weighted Average Exercise Price, Options Exercised | 0.10 | |
Weighted Average Exercise Price, Outstanding at June 30, 2016 | 0.48 | $ 0.48 |
Weighted Average Exercise Price, Exercisable at June 30, 2016 | $ 0.54 | |
Weighted Average Remaining Contractual Term, Outstanding | 6 years 3 months 18 days | 6 years 6 months |
Weighted Average Remaining Contractual Term, Exercisable at June 30, 2016 | 5 years 6 months | |
Aggregate Intrinsic Value, Outstanding | $ 975,699 | $ 904,409 |
Aggregate Intrinsic Value, Exercisable at June 30, 2016 | $ 683,411 |
STOCK-BASED COMPENSATION (Det62
STOCK-BASED COMPENSATION (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Mar. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Noninterest Expense Directors Fees | $ 419,167 | |
Price Difference, Between Exercise Price And Quoted Price | $ 0.33 | $ 0.31 |
Stock Issued During Period Value Payment Of Employee Salaries | $ 10,417 | |
Stock Option Plan 2014 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | |
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |
Employee Stock Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock Issued During Period Shares Payment Of Employee Salaries | 32,244 | |
Common Stock [Member] | Employee Stock Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock Issued During Period Shares Payment Of Employee Salaries | 32,244 | |
Stock Issued During Period Value Payment Of Employee Salaries | $ 10,417 | |
Director [Member] | Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock Issued During Period Shares Payment Of Directors Fees | 56,896 | |
Noninterest Expense Directors Fees | $ 33,361 | |
Shares For Payment Of Directors Fees Outstanding | 103,020 | |
Stock Issued During Period Value Payment Of Directors Fees | $ 18,361 | |
Management [Member] | Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock Issued During Period Shares Payment Of Employee Salaries | 213,667 | |
Shares For Payment Of Employee And Management Fees Outstanding | 1,296,397 | |
Stock Issued During Period Value Payment Of Employee Salaries | $ 661,857 |
CONCENTRATIONS AND CREDIT RISK
CONCENTRATIONS AND CREDIT RISK (Details Textual) | 3 Months Ended | 12 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | Mar. 31, 2016 | |
Sales Revenue, Net [Member] | Customer One [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 45.00% | 47.00% | |
Sales Revenue, Net [Member] | Customer Two [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 34.00% | 44.00% | |
Sales Revenue, Net [Member] | Customer Three [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 13.00% | 5.00% | |
Accounts Receivable [Member] | Customer One [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 53.00% | 54.00% | |
Accounts Receivable [Member] | Customer Two [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 32.00% | 30.00% | |
Accounts Receivable [Member] | Customer Three [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 11.00% | 8.00% | |
Cost of Goods, Total [Member] | Supplier Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 80.00% | 80.00% | |
Cost of Goods, Total [Member] | Supplier One [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 63.00% | 42.00% | |
Cost of Goods, Total [Member] | Supplier Two [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 9.00% | 12.00% | |
Cost of Goods, Total [Member] | Supplier Three [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 6.00% | 9.00% |
SEGMENT RESULTS (Details)
SEGMENT RESULTS (Details) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Revenue by Segment | $ 3,271,146 | $ 2,163,105 |
Operating Income (Loss) by Segment | 1,096,524 | 4,735,070 |
Generic products ANDA [Member] | ||
Revenue by Segment | 3,021,146 | 2,079,772 |
Operating Income (Loss) by Segment | 172,921 | 854,473 |
Branded products NDA [Member] | ||
Revenue by Segment | 250,000 | 83,333 |
Operating Income (Loss) by Segment | $ (608,677) | $ (2,352,552) |
SEGMENT RESULTS (Details 1)
SEGMENT RESULTS (Details 1) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Operating income (loss) by segment | $ 1,096,524 | $ 4,735,070 |
Corporate unallocated costs | (462,125) | (370,075) |
Interest revenue | 3,109 | 0 |
Interest expense | (68,943) | (76,228) |
Depreciation and amortization expense | (22,392) | (157,915) |
Significant non-cash items | (317,290) | (376,894) |
Change in fair value of derivative instruments | 2,399,921 | 7,214,261 |
Business Segment [Member] | ||
Operating income (loss) by segment | $ (435,756) | $ (1,498,079) |
COLLABORATIVE AGREEMENT WITH 66
COLLABORATIVE AGREEMENT WITH EPIC PHARMA LLC (Details Textual) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |
Jan. 31, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | |
Epic Collaborative Agreement [Member] | |||
Revenue Recognition, Milestone Method [Line Items] | |||
Non Refundable Milestone Payments | $ 15 | ||
Revenue Recognition, Milestone Method, Description | On June 4, 2015, the Company entered into the 2015 Epic License Agreement, which provides for the exclusive right to market, sell and distribute, by Epic Pharma LLC (“Epic”) of SequestOx™, an abuse deterrent opioid which employs the Company’s proprietary pharmacological abuse-deterrent technology. Epic will be responsible for payment of product development and pharmacovigilance costs, sales and marketing of SequestOx™, and Elite will be responsible for the manufacture of the product. Under the 2015 Epic License Agreement, Epic will pay Elite non-refundable payments totaling $15 million, with such amount representing the cost of an exclusive license to ELI-200, the cost of developing the product and certain filings and a royalty based on an amount equal to 50% of profits derived from net product sales as defined in the 2015 Epic License Agreement. The initial term of the exclusive right to product development sales and distribution is five years (“Epic Exclusivity Period”); the license is renewable upon mutual agreement at the end of the initial term. | ||
Proceeds from Divestiture of Interest in Consolidated Subsidiaries | $ 5 | ||
Epic License Agreement [Member] | |||
Revenue Recognition, Milestone Method [Line Items] | |||
Proceeds from License Fees Received | $ 7.5 | ||
Deferred Revenue, Additions | $ 2.5 |
RELATED PARTY TRANSACTION AGR67
RELATED PARTY TRANSACTION AGREEMENTS WITH EPIC PHARMA LLC (Details Textual) $ in Thousands | 3 Months Ended |
Jun. 30, 2016USD ($) | |
Epic Pharma Llc [Member] | |
Milestone Payments | $ 2,500 |
To Be Receive Future License Fees | 7,500 |
Due to Related Parties | 1,800 |
Related Party Transaction, Amounts of Transaction | 1,000 |
Epic Generic Agreement [Member] | |
Related Party Transaction, Amounts of Transaction | 800 |
Epic [Member] | |
Milestone Payments | $ 10,000 |
MANUFACTURING, LICENSE AND DE68
MANUFACTURING, LICENSE AND DEVELOPMENT AGREEMENTS (Details Textual) - USD ($) $ in Thousands | Sep. 10, 2010 | Jun. 30, 2016 |
Revenue Recognition, Milestone Method, Milestone | The milestones, totaling $500k (with $405k already received), consist of amounts due upon the first shipment of each identified product, as follows: Phentermine 37.5mg tablets ($145k), Phentermine 15 & 30mg capsules ($45k), Hydromorphone 8mg ($125k), Naltrexone 50mg ($95k) and the balance of $95k due in relation to the first shipment of generic products which still require marketing authorizations from the FDA, and to which there can be no assurances of such marketing authorizations being granted and accordingly there can be no assurances that the Company will earn and receive these milestone amounts. | |
Precision Dose License Agreement [Member] | ||
License and Maintenance Revenue | $ 200 |
SUBSEQUENT EVENTS (Details Text
SUBSEQUENT EVENTS (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | |
Aug. 03, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | |
Subsequent Event [Line Items] | |||
Proceeds from Issuance of Common Stock | $ 2,470,338 | $ 2,040,591 | |
Subsequent Event [Member] | LPC-40 Purchase Agreement [Member] | |||
Subsequent Event [Line Items] | |||
Proceeds from Issuance of Common Stock | $ 0.7 | ||
Stock Issued During Period, Shares, Issued for Capital Purchase Agreement | 0.03 | ||
Stock Issued During Period, Shares, New Issues | 2.71 |