x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
|
|
EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
|
|
EXCHANGE ACT OF 1934
|
Commission File Number: 333-15697
|
ELITE PHARMACEUTICALS, INC.
|
(Exact name of registrant as specified in its charter)
|
Delaware
|
22-3542636
|
|
(State or other jurisdiction of incorporation or organization)
|
|
(I.R.S. Employer Identification No.)
|
165 Ludlow Avenue, Northvale, New Jersey
|
07647
|
|
(Address of principal executive offices)
|
|
(Zip Code)
|
(201) 750-2646
|
(Registrant's telephone number, including area code)
|
Large Accelerated filer
¨
|
Accelerated Filer
¨
|
Non-Accelerated Filer
¨
|
Smaller Reporting Company
x
|
September 30,
2011
(Unaudited)
|
March 31,
2011
(Audited)
|
|||||||
ASSETS
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
$ | 1,339,078 | $ | 1,825,858 | ||||
Accounts receivable (net of allowance for doubtful accounts of -0-)
|
252,659 | 571,667 | ||||||
Inventories (net of reserve of $93,338 and $1,047,456, respectively)
|
382,239 | 616,362 | ||||||
Prepaid expenses and other current assets
|
104,518 | 133,472 | ||||||
Total Current Assets
|
2,078,494 | 3,147,359 | ||||||
PROPERTY AND EQUIPMENT,
net of accumulated depreciation of $4,427,377 and $4,189,618, respectively
|
4,243,696 | 4,118,274 | ||||||
INTANGIBLE ASSETS
– net of accumulated amortization of $-0- and $-0-, respectively
|
613,833 | 597,556 | ||||||
OTHER ASSETS
|
||||||||
Investment in Novel Laboratories, Inc.
|
3,329,322 | 3,329,322 | ||||||
Security deposits
|
13,725 | 28,377 | ||||||
Restricted cash – debt service for EDA bonds
|
287,131 | 291,420 | ||||||
EDA bond offering costs, net of accumulated amortization of $85,964 and $78,898, respectively
|
268,488 | 275,554 | ||||||
Total Other Assets
|
3,898,666 | 3,924,673 | ||||||
TOTAL ASSETS
|
$ | 10,834,689 | $ | 11,787,862 |
September 30,
2011
(Unaudited)
|
March 31,
2011
(Audited)
|
|||||||
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
||||||||
CURRENT LIABILITIES
|
||||||||
EDA bonds payable
|
$ | 3,385,000 | $ | 3,385,000 | ||||
Short term loans and current portion of long-term debt
|
13,517 | 13,105 | ||||||
Accounts payable and accrued expenses
|
937,285 | 935,797 | ||||||
Customer Deposits
|
— | 39,400 | ||||||
Deferred revenues – current
|
13,333 | 13,333 | ||||||
Preferred share derivative interest payable
|
124,370 | 282,680 | ||||||
Total Current Liabilities
|
4,473,505 | 4,669,315 | ||||||
LONG TERM LIABILITIES
|
||||||||
Deferred revenues
|
172,224 | 178,890 | ||||||
Other long term liabilities
|
75,163 | 75,463 | ||||||
Derivative liability – preferred shares
|
16,172,177 | 14,192,329 | ||||||
Derivative liability – warrants
|
13,629,540 | 10,543,145 | ||||||
Total Long Term Liabilities
|
30,049,104 | 24,989,827 | ||||||
TOTAL LIABILITIES
|
34,522,609 | 29,659,142 | ||||||
STOCKHOLDERS’ DEFICIT
|
||||||||
Common stock – par value $0.001, Authorized 355,516,558 shares Issued and outstanding – 254,779,074 shares and 180,545,657 shares, respectively
|
254,780 | 180,546 | ||||||
Additional paid-in-capital
|
108,039,275 | 97,116,044 | ||||||
Accumulated deficit
|
(131,675,134 | ) | (114,861,029 | ) | ||||
Treasury stock at cost (100,000 common shares)
|
(306,841 | ) | (306,841 | ) | ||||
TOTAL STOCKHOLDERS’ DEFICIT
|
(23,687,920 | ) | (17,871,280 | ) | ||||
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
$ | 10,834,689 | $ | 11,787,862 |
THREE MONTHS ENDED
SEPTEMBER 30,
|
SIX MONTHS ENDED
SEPTEMBER 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
REVENUES
|
||||||||||||||||
Manufacturing Fees
|
$ | 78,294 | $ | 767,341 | $ | 677,733 | $ | 1,334,410 | ||||||||
Royalties & Profit Splits
|
100,069 | 169,901 | 410,000 | 350,935 | ||||||||||||
Lab Fee Revenues
|
95,769 | 57,404 | 176,275 | 141,221 | ||||||||||||
Total Revenues
|
274,132 | 994,646 | 1,264,108 | 1,826,566 | ||||||||||||
COSTS OF REVENUES
|
76,331 | 565,624 | 501,700 | 977,295 | ||||||||||||
Gross Profit
|
197,801 | 429,022 | 762,408 | 849,271 | ||||||||||||
OPERATING EXPENSES
|
||||||||||||||||
Research and Development
|
198,212 | 150,436 | 643,709 | 315,444 | ||||||||||||
General and Administrative
|
476,897 | 379,104 | 801,494 | 635,345 | ||||||||||||
Non-cash compensation through issuance of stock options
|
6,113 | 10,329 | 12,226 | 25,687 | ||||||||||||
Depreciation and Amortization
|
108,181 | 25,960 | 233,115 | 104,291 | ||||||||||||
Total Operating Expenses
|
789,403 | 565,829 | 1,690,544 | 1,080,767 | ||||||||||||
LOSS FROM OPERATIONS
|
(591,602 | ) | (136,807 | ) | (928,136 | ) | (231,496 | ) | ||||||||
OTHER INCOME / (EXPENSES)
|
||||||||||||||||
Interest expense, net
|
(57,931 | ) | (57,737 | ) | (115,301 | ) | (115,806 | ) | ||||||||
Change in fair value of warrant derivatives
|
10,497,037 | 900,047 | (3,086,393 | ) | 2,723,747 | |||||||||||
Change in fair value of preferred share derivatives
|
4,196,187 | 1,505,333 | (12,414,600 | ) | (4,569,005 | ) | ||||||||||
Interest expense attributable to preferred share derivatives
|
(124,370 | ) | (306,440 | ) | (267,175 | ) | (670,359 | ) | ||||||||
Discount in Series E issuance attributable to beneficial conversion features
|
— | (39,132 | ) | — | (39,132 | ) | ||||||||||
Total Other Income / (Expense)
|
14,510,923 | 2,002,071 | (15,883,469 | ) | (2,670,555 | ) | ||||||||||
INCOME (LOSS) BEFORE PROVISION FOR INCOME TAXES
|
13,919,321 | 1,865,264 | (16,811,605 | ) | (2,902,051 | ) | ||||||||||
PROVISION FOR INCOME TAXES
|
— | 1,040 | 2,500 | 3,120 | ||||||||||||
NET INCOME (LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS
|
$ | 13,919,321 | $ | 1,864,224 | $ | (16,814,105 | ) | $ | (2,905,171 | ) | ||||||
NET INCOME (LOSS) PER SHARE
|
||||||||||||||||
Basic
|
$ | 0.06 | $ | 0.02 | $ | (0.07 | ) | $ | (0.03 | ) | ||||||
Diluted
|
$ | 0.03 | $ | 0.01 | $ | (0.07 | ) | $ | (0.03 | ) | ||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
|
||||||||||||||||
Basic
|
248,247,253 | 92,367,680 | 240,189,326 | 89,760,532 | ||||||||||||
Diluted
|
454,162,476 | 299,999,783 | 240,189,326 | 89,760,532 |
Common Stock
|
Treasury Stock
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Additional
Paid-In
Capital
|
Shares
|
Amount
|
Accumulated
Deficit
|
Stockholders’
Deficit
|
||||||||||||||||||||||
Balance at Mar 31, 2011
|
180,545,657 | $ | 180,546 | $ | 97,116,044 | 100,000 | $ | (306,841 | ) | $ | (114,861,029 | ) | $ | (17,871,280 | ) | |||||||||||||
Net Loss
|
(16,814,105 | ) | (16,814,105 | ) | ||||||||||||||||||||||||
Common shares issued in lieu of cash in payment of preferred share derivative interest expense
|
5,727,703 | 5,728 | 419,757 | 425,485 | ||||||||||||||||||||||||
Conversion of Series B Preferred Shares into Common Shares
|
660,000 | 660 | 71,940 | 72,600 | ||||||||||||||||||||||||
Conversion of Series C Preferred Shares into Common Shares
|
6,826,667 | 6,827 | 619,707 | 626,534 | ||||||||||||||||||||||||
Conversion of Series D Preferred Shares into Common Shares
|
58,042,857 | 58,043 | 9,415,672 | 9,473,715 | ||||||||||||||||||||||||
Conversion of Series E Preferred Shares into Common Shares
|
2,976,190 | 2,976 | 383,929 | 386,905 | ||||||||||||||||||||||||
Non-cash compensation through the issuance of stock options
|
12,226 | 12,226 | ||||||||||||||||||||||||||
Balance at September 30, 2011
|
254,779,074 | $ | 254,780 | $ | 108,039,275 | 100,000 | $ | (306,841 | ) | $ | (131,675,134 | ) | $ | (23,687,920 | ) |
SIX MONTHS ENDED SEPTEMBER 30,
|
||||||||
2011
|
2010
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net Loss
|
$ | (16,814,105 | ) | $ | (2,905,171 | ) | ||
Adjustments to reconcile net loss to cash used in operating activities:
|
||||||||
Depreciation and amortization
|
244,796 | 241,626 | ||||||
Change in fair value of warrant derivative liability
|
3,086,393 | (2,723,747 | ) | |||||
Change in fair value of preferred share derivative liability
|
12,414,600 | 4,569,005 | ||||||
Discount in Series E issuance attributable to embedded beneficial conversion feature
|
39,132 | |||||||
Preferred share derivative interest satisfied by the issuance of common stock
|
425,485 | 670,360 | ||||||
Non-cash compensation satisfied by the issuance of common stock and options
|
12,226 | 25,687 | ||||||
Non-cash rent expense
|
5,791 | 22,584 | ||||||
Non-cash lease accretion
|
628 | 298 | ||||||
Changes in Assets and Liabilities
|
||||||||
Accounts receivable
|
319,008 | (36,372 | ) | |||||
Inventories
|
234,123 | 40,120 | ||||||
Prepaid and other current assets
|
28,957 | 30,868 | ||||||
Security deposits
|
14,652 | (13,725 | ) | |||||
Accounts payable, accrued expenses and other current liabilities
|
1,488 | 195,233 | ||||||
Deferred revenues and Customer deposits
|
(46,066 | ) | 198,889 | |||||
Derivative interest payable
|
(158,310 | ) | — | |||||
.
|
||||||||
NET CASH PROVIDED BY/(USED BY) OPERATING ACTIVITIES
|
(230,333 | ) | 354,788 | |||||
CASH FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Purchases of property and equipment
|
(49,784 | ) | (23,779 | ) | ||||
Cost of leasehold improvements
|
(313,367 | ) | (35,610 | ) | ||||
Costs incurred for intellectual property assets
|
(16,276 | ) | (258,464 | ) | ||||
Proceeds from sale of retired equipment
|
— | 30,000 | ||||||
Withdrawals from restricted cash, net
|
4,286 | 2,420 | ||||||
NET CASH USED IN INVESTING ACTIVITIES
|
(375,138 | ) | (285,433 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Proceeds from issuance of Series E Convertible Preferred Stock
|
125,000 | |||||||
Other loan payments
|
(6,305 | ) | (53,689 | ) | ||||
NET CASH (USED IN) / PROVIDED BY FINANCING ACTIVITIES
|
118,695 | (53,689 | ) | |||||
NET CHANGE IN CASH AND CASH EQUIVALENTS
|
(486,777 | ) | 15,666 | |||||
CASH AND CASH EQUIVALENTS – beginning of period
|
1,825,858 | 578,187 | ||||||
CASH AND CASH EQUIVALENTS – end of period
|
$ | 1,339,078 | $ | 593,853 | ||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
|
||||||||
Cash paid for interest
|
113,850 | 115,524 | ||||||
Cash paid for taxes
|
2,500 | 3,120 | ||||||
SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES
|
||||||||
Non-Cash acquisition of Naltrexone ANDA
|
— | 200,000 |
NOTE 1
|
-
|
BASIS OF PRESENTATION AND LIQUIDITY
|
|
The information in this quarterly report on Form 10-Q includes the results of operations of Elite Pharmaceuticals, Inc. and its consolidated subsidiaries (collectively the “Company”) for the three and six months ended September 30, 2011 and 2010. The accompanying unaudited condensed consolidated financial statements have been prepared pursuant to rules and regulations of the Securities and Exchange Commission in accordance with accounting principles generally accepted for interim financial statement presentation. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (“GAAP”) for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the condensed consolidated financial position, results of operations and cash flows of the Company for the periods presented have been included.
|
|
The financial results for the interim periods are not necessarily indicative of the results to be expected for the full year or future interim periods.
|
|
The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended March 31, 2011. There have been no changes in significant accounting policies since March 31, 2011.
|
NOTE 2
|
-
|
CASH AND CASH EQUIVALENTS
|
NOTE 3
|
-
|
INVENTORIES
|
NOTE 4
|
-
|
INTANGIBLE ASSETS
|
Intangible assets at March 31, 2011 (audited)
|
||||
Patent application costs
|
147,556 | |||
ANDA acquisitions
|
450,000 | |||
Total Intangible Assets at March 31, 2011 (audited)
|
597,556 | |||
Intangible asset costs capitalized during the six months ended September 30, 2011
|
||||
Patent application costs
|
16,277 | |||
ANDA acquisition costs
|
— | |||
Amortization of intangible assets during the six months ended September 30, 2011
|
||||
Patent application costs
|
— | |||
ANDA acquisition costs
|
— | |||
Intangible assets at September 30, 2011 (unaudited)
|
||||
Patent application costs
|
163,833 | |||
ANDA acquisitions costs
|
450,000 | |||
Total Intangible Assets at September 30, 2011 (unaudited)
|
613,833 |
NOTE 5
|
-
|
NJEDA BONDS
|
NOTE 6
|
-
|
PREFERRED STOCK DERIVATIVE LIABILITIES
|
Preferred Stock Derivative Liability as of September 30, 2011
|
||||||||||||||||||||
Series B
|
Series C
|
Series D
|
Series E
|
Total
|
||||||||||||||||
Preferred shares Outstanding
|
796.6 | 4,394 | — | 3,112.5 | 8,303.1 | |||||||||||||||
Underlying common shares into which Preferred may convert
|
5,310,393 | 29,293,333 | — | 125,516,832 | 160,120,558 | |||||||||||||||
Closing price on valuation date
|
$ | 0.101 | $ | 0.101 | n/a | $ | 0.101 | $ | 0.101 | |||||||||||
Preferred stock derivative liability at September 30, 2011
|
$ | 536,350 | $ | 2,958,627 | $ | — | $ | 12,677,200 | $ | 16,172,177 | ||||||||||
Preferred stock derivative liability at June 30, 2011
|
$ | 97,593 | $ | 572,087 | $ | — | $ | 20,659,722 | $ | 21,329,402 | ||||||||||
Preferred stock derivative liability at March 31, 2011
|
$ | 56,961 | $ | 333,906 | $ | 4,527,343 | $ | 9,274,119 | $ | 14,192,329 |
CHANGE IN VALUE OF PREFERRED STOCK DERIVATIVE LIABILITY
|
||||||||||||||||
Three months ended Sept 30,
|
Six months ended Sept 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Change in Preferred Stock Derivative Liability
|
$ | 4,196,187 | $ | 1,505,333 | $ | (12,414,600 | ) | $ | (4,569,005 | ) |
FAIR VALUE OF WARRANT DERIVATIVE LIABILITY
|
||||||||||||
March 31
2011
|
June 30
2011
|
Sept 30
2011
|
||||||||||
Risk-Free interest rate
|
0.09% - 2.9 | % | 0.3% - 2.5 | % | 0.02% - 1.3 | % | ||||||
Expected volatility
|
138% - 194 | % | 153% - 217 | % | 133% - 196 | % | ||||||
Expected life (in years)
|
0.3 – 7.0 | 0.0 – 6.8 | 0.2 – 6.5 | |||||||||
Expected dividend yield
|
— | — | — | |||||||||
Number of warrants
|
155,325,048 | 154,334,659 | 154,153,308 | |||||||||
Fair Value – Warrant Derivative Liability
|
$ | 10,543,145 | $ | 24,126,576 | $ | 13,629,540 |
CHANGE IN VALUE OF WARRANT DERIVATIVE LIABILITY
|
||||||||||||||||
Three months ended Sept 30,
|
Six months ended Sept 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Change in Warrant Derivative Liability
|
$ | 10,497,037 | $ | 900,047 | $ | (3,086,393 | ) | $ | 2,723,747 |
NOTE 7 -
|
PREFERRED SHARE DERIVATIVE INTEREST PAYABLE
|
NOTE 8 -
|
OPERATING LEASES
|
Fiscal year ended March 31, 2012
|
$ | 79,248 | ||
Fiscal year ended March 31, 2013
|
81,228 | |||
Fiscal year ended March 31, 2014
|
83,259 | |||
Fiscal year ended March 31, 2015
|
85,344 | |||
Fiscal year ended March 31, 2016
|
87,363 | |||
Total Minimum 5 year lease payments
|
$ | 416,442 |
RENT EXPENSE
|
||||||||||||||||
Three
Months
Ended
Sept 30, 2011
|
Three
Months
Ended
Sept 30, 2010
|
Six
Months
Ended
Sept 30, 2011
|
Six
Months
Ended
Sept 30, 2010
|
|||||||||||||
Rent Expense
|
$ | 22,584 | $ | 22,584 | $ | 45,169 | $ | 22,584 | ||||||||
Change in deferred rent liability
|
$ | 2,895 | $ | 22,584 | $ | 5,791 | $ | 22,584 |
DEFERRED RENT LIABILITY (LONG-TERM LIABILITY)
|
||||||||||||
March 31
2011
|
June 30
2011
|
September 30
2011
|
||||||||||
Balance of Deferred Rent Liability
|
$ | 48,064 | $ | 50,960 | $ | 53,855 |
NOTE 9 -
|
DEFERRED REVENUES
|
NOTE 10 -
|
STOCKHOLDERS’ EQUITY
|
Description
|
Shares
Of
Common Stock
|
|||
Common shares issued in lieu of cash in payment of preferred share derivative interest expenses totaling $282,680 which were due and owing as of March 31, 2011 to holders of the Company’s Series B, Series C and Series D Preferred Share derivative instruments
|
4,775,017 | |||
Common shares issued in lieu of cash in payment of preferred share derivative interest expenses totaling $142,805 which were due and owing as of June 30, 2011 to holders of the Company’s Series B, Series C and Series D Preferred Share derivative instruments
|
952,686 | |||
Common shares issued pursuant to the conversion of Series B Preferred Share derivatives, with such derivative liabilities being valued at an aggregate of $72,600 at the time of their conversion
|
660,000 | |||
Common shares issued pursuant to the conversion of Series C Preferred Share derivatives, with such derivative liabilities being valued at an aggregate of $626,534 at the time of their conversion
|
6,826,667 | |||
Common shares issued pursuant to the conversion of Series D Preferred Share derivatives, with such derivative liabilities being valued at an aggregate of $9,473,715 at the time of their conversion
|
58,042,857 | |||
Common shares issued pursuant to the conversion of Series E Preferred Share derivatives, with such derivative liabilities being valued at an aggregate of $386,905 at the time of their conversion
|
2,976,190 | |||
Total Common Shares issued during the six months ended September 30, 2011
|
74,233,417 |
|
Options
|
NOTE 11 -
|
PER SHARE INFORMATION
|
For the Three Months
Ended Sept 30,
|
For the Six Months
Ended Sept 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Numerator
|
||||||||||||||||
Net Income (loss) attributable to common shareholders - Basic
|
13,919,321 | $ | 1,864,224 | $ | (16,814,105 | ) | $ | (2,905,171 | ) | |||||||
Net Income (loss) attributable to common shareholders - Diluted
|
14,042,702 | 1,864,224 | ||||||||||||||
Denominator
|
||||||||||||||||
Weighted-average shares of common stock outstanding
|
248,247,253 | 92,367,680 | 240,189,326 | 89,760,532 | ||||||||||||
Dilutive effect of stock options, warrants and convertible securities
|
205,915,223 | 207,632,103 | ||||||||||||||
Net (loss) income per share
|
||||||||||||||||
Basic
|
$ | 0.06 | $ | 0.02 | $ | (0.07 | ) | $ | (0.03 | ) | ||||||
Diluted
|
$ | 0.03 | $ | 0.01 |
NOTE 12 -
|
SUBSEQUENT EVENTS
|
|
1.
|
Elect seven directors to serve until the next Annual Meeting of Stockholders:
|
Nominee
|
Number of Votes For
|
Number of Votes Withheld
|
||
Jerry Treppel
|
206,630,753
|
1,917,727
|
||
Ashok Nigalaye
|
206,580,626
|
1,967,854
|
||
Jeenarine Narine
|
206,636,776
|
1,911,704
|
||
Ram Potti
|
202,579,926
|
5,968,554
|
||
Barry Dash
|
207,692,926
|
855,554
|
||
Chris Dick
|
202,572,217
|
5,976,263
|
||
Jeffrey Whitnell
|
|
207,697,926
|
|
850,554
|
|
2.
|
Increase the Number of shares of common stock the Company is authorized to issue from 355,517,558 shares to 690,000,000:
|
Number of Votes FOR
|
Number of Votes AGAINST
|
Number of Votes ABSTAINED
|
||
299,103,821
|
|
24,138,527
|
|
2,221,432
|
|
3.
|
Grant discretionary authority to the Board of Directors until December 31, 2012 (a) to change the Company’s state of incorporation from Delaware to Nevada, by merging with a wholly-owned subsidiary to be incorporated in Nevada pursuant to an Agreement and Plan of Merger or (b)determine not to proceed with the reincorporation:
|
Number of Votes FOR
|
Number of Votes AGAINST
|
Number of Votes ABSTAINED
|
||
206,673,433
|
|
1,665,001
|
|
1,304,521
|
|
4.
|
Ratify the appointment of Demetrius & Company, LLC as the Company's independent auditor of our financial statements for the fiscal year ending March, 31 2012:
|
Number of Votes FOR
|
Number of Votes AGAINST
|
Number of Votes ABSTAINED
|
||
322,429,436
|
|
347,567
|
|
2,686,780
|
|
·
|
Phentermine 37.5mg tablets
|
|
·
|
Lodrane D® immediate release Brompheniramine/Pseudoephedrine capsules
|
|
·
|
Phentermine HCl 37.5mg tablets (“Phentermine 37.5mg”)
|
|
·
|
Hydromorphone HCl 8mg tablets (“Hydromorphone 8mg”)
|
|
·
|
Naltrexone HCl 50mg tablets (“Naltrexone 50mg”)
|
|
·
|
Mikah Pharma LLC (the “Mikah Development Agreement”)
|
|
·
|
Hi-Tech Pharmacal Co. (the “Hi-Tech Development Agreement”)
|
Exhibit
Number
|
Description
|
|
3.1(a)
|
Certificate of Incorporation of the Company, together with all other amendments thereto, as filed with the Secretary of State of the State of Delaware, incorporated by reference to (a) Exhibit 4.1 to the Registration Statement on Form S-4 (Reg. No. 333-101686), filed with the SEC on December 6, 2002 (the “Form S-4”), (b) Exhibit 3.1 to the Company’s Current Report on Form 8-K dated July 28, 2004 and filed with the SEC on July 29, 2004, (c) Exhibit 3.1 to the Company’s Current Report on Form 8-K dated June 26, 2008 and filed with the SEC on July 2, 2008, and (d) Exhibit 3.1 to the Company’s Current Report on Form 8-K dated December 19, 2008 and filed with the SEC on December 23, 2008.
|
|
3.1(b)
|
Certificate of Designations, Preferences and Rights of Series A Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 4.5 to the Current Report on Form 8-K dated October 6, 2004, and filed with the SEC on October 12, 2004.
|
|
3.1(c)
|
Certificate of Retirement with the Secretary of the State of the Delaware to retire 516,558 shares of the Series A Preferred Stock, as filed with the Secretary of State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated March 10, 2006, and filed with the SEC on March 14, 2006.
|
|
3.1(d)
|
Certificate of Designations, Preferences and Rights of Series B 8% Convertible Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated March 15, 2006, and filed with the SEC on March 16, 2006.
|
3.1(e)
|
Amended Certificate of Designations of Preferences, Rights and Limitations of Series B 8% Convertible Preferred Stock, as filed with the Secretary of State of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated April 24, 2007, and filed with the SEC on April 25, 2007.
|
|
3.1(f)
|
Certificate of Designations, Preferences and Rights of Series C 8% Convertible Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K dated April 24, 2007, and filed with the SEC on April 25, 2007.
|
|
3.1(g)
|
Amended Certificate of Designations, Preferences and Rights of Series C 8% Convertible Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated April 24, 2007, and filed with the SEC on April 25, 2007
|
|
3.1(h)
|
Amended Certificate of Designations of Preferences, Rights and Limitations of Series B 8% Convertible Preferred Stock, as filed with the Secretary of State of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated September 15, 2008, and filed with the SEC on September 16, 2008.
|
|
3.1(i)
|
Amended Certificate of Designations, Preferences and Rights of Series C 8% Convertible Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K dated September 15, 2008, and filed with the SEC on September 16, 2008.
|
|
3.1(j)
|
Amended Certificate of Designations of Preferences, Rights and Limitations of Series D 8% Convertible Preferred Stock, as filed with the Secretary of State of the State of Delaware, incorporated by reference to Exhibit 3.3 to the Current Report on Form 8-K dated September 15, 2008, and filed with the SEC on September 16, 2008.
|
|
3.1(k)
|
Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock, as filed with the Secretary of State of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated June 1, 2009, and filed with the SEC on June 5, 2009.
|
|
3.1(l)
|
Amended Certificate of Designations of the Series D 8% Convertible Preferred Stock as filed with the Secretary of State of the State of Delaware on June 29, 2010, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated July 1, 2010 and filed with the SEC on July 1, 2010
|
|
3.1(m)
|
Amended Certificate of Designations of the Series E Convertible Preferred Stock as filed with the Secretary of State of the State of Delaware on June 29, 2010, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K, dated July 1, 2010 and filed with the SEC on July1, 2010
|
|
3.1 (o)
|
Amended Certificate of Designations of the Series B Convertible Preferred Stock as filed with the Secretary of State of the State of Delaware on August 12, 2011, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated August 12, 2011 and filed with the SEC on August 18, 2011
|
|
3.1 (p)
|
Amended Certificate of Designations of the Series C Convertible Preferred Stock as filed with the Secretary of State of the State of Delaware on August 12, 2011, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K, dated August 12, 2011 and filed with the SEC on August 18, 2011
|
|
3.1 (q)
|
Certificate of Correction Relating to the Amended Certificate of Designations of the Series B Convertible Preferred Stock as filed with the Secretary of State of the State of Delaware on August 12, 2011, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated August 31, 2011 and filed with the SEC on August 31, 2011
|
3.1 (R)
|
Certificate of Correction Relating to the Amended Certificate of Designations of the Series C Convertible Preferred Stock as filed with the Secretary of State of the State of Delaware on August 12, 2011, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K, dated August 31, 2011 and filed with the SEC on August 31, 2011
|
|
3.2
|
By-Laws of the Company, as amended, incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form SB-2 (Reg. No. 333-90633) made effective on February 28, 2000 (the “Form SB-2”).
|
|
4.1
|
Form of specimen certificate for Common Stock of the Company, incorporated by reference to Exhibit 4.1 to the Form SB-2.
|
|
4.2
|
Form of specimen certificate for Series A 8% Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.5 to the Current Report on Form 8-K, dated October 6, 2004, and filed with the SEC on October 12, 2004.
|
|
4.3
|
Form of specimen certificate for Series B 8% Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.
|
|
4.4
|
Form of specimen certificate for Series C 8% Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April 25, 2007.
|
|
4.5
|
Warrant to purchase 100,000 shares of Common Stock issued to DH Blair Investment Banking Corp., incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q for the period ended September 30, 2004.
|
|
4.6
|
Warrant to purchase 50,000 shares of Common Stock issued to Jason Lyons incorporated by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q for the period ended June 30, 2004.
|
|
4.7
|
Form of Warrant to purchase shares of Common Stock issued to designees of lender with respect to financing of an equipment loan incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q for the period ended June 30, 2004.
|
|
4.8
|
Form of Short Term Warrant to purchase shares of Common Stock issued to purchasers in the private placement which initially closed on October 6, 2004 (the “Series A Financing”), incorporated by reference to Exhibit 4.6 to the Current Report on Form 8-K, dated October 6, 2004, and filed with the SEC on October 12, 2004
|
|
4.9
|
Form of Long Term Warrant to purchase shares of Common Stock issued to purchasers in the Series A Financing, incorporated by reference to Exhibit 4.7 to the Current Report on Form 8-K, dated October 6, 2004, and filed with the SEC on October 12, 2004.
|
|
4.10
|
Form of Warrant to purchase shares of Common Stock issued to the Placement Agent, in connection with the Series A Financing, incorporated by reference to Exhibit 4.8 to the Current Report on Form 8-K, dated October 6, 2004, and filed with the SEC on October 12, 2004.
|
|
4.11
|
Form of Replacement Warrant to purchase shares of Common Stock in connection with the offer to holders of Warrants in the Series A Financing (the “Warrant Exchange”), incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated December 14, 2005, and filed with the SEC on December 20, 2005.
|
4.12
|
Form of Warrant to purchase shares of Common Stock to the Placement Agent, in connection with the Warrant Exchange, incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated December 14, 2005, and filed with the SEC on December 20, 2005.
|
|
4.13
|
Form of Warrant to purchase shares of Common Stock issued to purchasers in the private placement which closed on March 15, 2006 (the “Series B Financing”), incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.
|
|
4.14
|
Form of Warrant to purchase shares of Common Stock issued to purchasers in the Series B Financing, incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.
|
|
4.15
|
Form of Warrant to purchase shares of Common Stock issued to the Placement Agent, in connection with the Series B Financing, incorporated by reference to Exhibit 4.4 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.
|
|
4.16
|
Form of Warrant to purchase 600,000 shares of Common Stock issued to Indigo Ventures, LLC, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated July 12, 2006 and filed with the SEC on July 18, 2006.
|
|
4.17
|
Form of Warrant to purchase up to 478,698 shares of Common Stock issued to VGS PHARMA, LLC, incorporated by reference to Exhibit 3(a) to the Current Report on Form 8-K, dated December 6, 2006 and filed with the SEC on December 12, 2006.
|
|
4.18
|
Form of Non-Qualified Stock Option Agreement for 1,750,000 shares of Common Stock granted to Veerappan Subramanian, incorporated by reference to Exhibit 3(b) to the Current Report on Form 8-K, dated December 6, 2006 and filed with the SEC on December 12, 2006.
|
|
4.19
|
Form of Warrant to purchase shares of Common Stock issued to purchasers in the private placement which closed on April 24, 2007 (the “Series C Financing”), incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April 25, 2007.
|
|
4.20
|
Form of Warrant to purchase shares of Common Stock issued to the placement agent in the Series C Financing, incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April 25, 2007.
|
|
4.21
|
Form of specimen certificate for Series D 8% Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated September 15, 2008 and filed with the SEC on September 16, 2008.
|
|
4.22
|
Form of Warrant to purchase shares of Common Stock issued to purchasers in the private placement which closed on September 15, 2008 (the “Series D Financing”), incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated September 15, 2008 and filed with the SEC on September 16, 2008.
|
|
4.23
|
Form of Warrant to purchase shares of Common Stock issued to the placement agent in the Series D Financing, incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K, dated September 15, 2008 and filed with the SEC on September 16, 2008.
|
|
4.24
|
Form of specimen certificate for Series E Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated June 1, 2009, and filed with the SEC on June 5, 2009.
|
|
4.25
|
Warrant to purchase shares of Common Stock issued to Epic Investments, LLC in the initial closing of the Strategic Alliance Agreement, dated as of March 18, 2009, by and among the Company, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated June 1, 2009, and filed with the SEC on June 5, 2009.
|
|
10.1 |
Amendment, dated as of November 1, 2011, to the Master Development and License Agreement, dated as of August 27, 2010, by and amount Mikah Pharma LLC and the Company. Confidential portions of this exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
|
31.1
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
31.2
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
32.1
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
32.2
|
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
101
|
|
The following materials from Elite Pharmaceuticals’ Quarterly Report on Form 10-Q for the period ended June 30, 2011, formatted in eXtensible Business Reporting Language (“XBRL”): (i) the Condensed Consolidated Statements of Income; (ii) the Condensed Consolidated Balance Sheets; (iii) the Condensed Consolidated Statements of Cash Flows; and (iv) Notes to Condensed Consolidated Financial Statements.
|
ELITE PHARMACEUTICALS, INC.
|
||||
Date:
|
November 14, 2011
|
/s/ Jerry Treppel
|
||
Jerry Treppel
|
||||
Chief Executive Officer
|
||||
(Principal Executive Officer)
|
||||
Date:
|
November 14, 2011
|
/s/ Carter J. Ward
|
||
Carter J. Ward
|
||||
Chief Financial Officer
|
||||
(Principal Financial and Accounting Officer)
|
1.
|
Severability. If any clause or provision of this Amendment is declared invalid or unenforceable by a court of competent jurisdiction, such provision shall be severed and the remaining provisions of the Amendment shall continue in full force and effect. The Parties shall use their best efforts to agree upon a valid and enforceable provision as a substitute for the severed provision, taking into account the intent of this Amendment.
|
2.
|
Notices. Any notice, request or other communication required to be given pursuant to the provisions of this Amendment shall be made in accordance with the provisions of the Amendment.
|
3.
|
Governing Law. All questions concerning the construction, validity, enforcement and interpretation of the Amendment shall be determined pursuant to the Governing Law provision of the Agreement.
|
4.
|
Independent Parties. The relationship of the Parties under this Amendment is that of independent contractors. Neither Party shall be deemed to be the agent of the other, nor shall the Parties be deemed to be partners or joint venturers, and neither is authorized to take any action binding upon the other. Elite expressly acknowledges for itself, its employees, agents and subcontractors, that none of them are employees of Mikah and that none of them are entitled to participate in any benefit plans of Mikah. Elite further acknowledges that none of its employees, agents or subcontractors are eligible to participate in any benefit plans of Mikah, even if it is later determined that the status of any of them was that of an employee during the period of this engagement of Elite by Mikah.
|
MIKAH PHARMA LLC | ELITE PHARMACEUTICALS, INC. | |
By: | By: | |
Name: Nasrat Hakim | Name: Chris C. Dick | |
Title: President and CEO | Title: President | |
1.
|
I have reviewed this Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 of Elite Pharmaceuticals, Inc. (the “Registrant”);
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
|
4.
|
The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e))
and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
(d)
|
Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting.
|
5.
|
The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
|
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.
|
Date
:
|
November 14, 2011
|
/s/ Jerry Treppel
|
||
Jerry Treppel
|
||||
Chief Executive Officer
|
||||
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 of Elite Pharmaceuticals, Inc. (the “Registrant”);
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
|
4.
|
The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
(d)
|
Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting.
|
5.
|
The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
|
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.
|
Date:
|
November 14, 2011
|
/s/ Carter J. Ward
|
||
Carter J. Ward
|
||||
Chief Financial Officer
|
||||
(Principal Accounting and Financial Officer)
|
Date:
|
November 14, 2011
|
/s/ Jerry Treppel
|
||
Jerry Treppel
|
||||
Chief Executive Officer
|
||||
of Elite Pharmaceuticals, Inc.
|
||||
(Principal Executive Officer)
|
Date:
|
November 14, 2011
|
/s/ Carter J. Ward
|
||
Carter J. Ward
|
||||
Chief Financial Officer of
|
||||
Elite Pharmaceuticals, Inc.
|
||||
(Principal Accounting and Financial Officer
|