NORTHVALE, N.J., Nov. 14, 2012 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (OTCBB:ELTP), a specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations and the manufacturing of generic pharmaceuticals, announced results for the fiscal second quarter ended September 30, 2012.
Consolidated revenues were $0.6 million for the quarter, an increase of 131% when compared to the comparable quarter of the prior year. This increase is the result of the continuing growth of the new revenue streams that have been created within the last eighteen months.
In addition, at the end of the quarter, Elite has received FDA approval for two new products, Phentermine 15mg capsules and Phentermine 30mg capsules although the launch of these products is dependent on resolution of the API issues discussed in our press release of October 12, 2012. Elite also currently has two products that are pending approval by the FDA for manufacturing transfer and a third undisclosed generic product under FDA review.
Consolidate loss from operations was $(0.5 million) for this quarter, compared with a loss from operations $(0.6 million) in the comparable quarter of the prior year. GAAP net income for the quarter, including non-cash expenses relating to the accounting treatment of preferred share and warrant derivatives was $1.0 million, compared to a GAAP net income of $13.9 million for the comparable quarter of the prior year, with the difference mostly being due to changes in the value of preferred shares and warrant derivatives. Basic earnings per share was $0.00, on a weighted average of 348.3 million common shares outstanding, compared to a basic earnings per common share of $0.06 and a weighted average common shares outstanding of 248.2 million in the comparable quarter of the prior year. Fully diluted earnings per share was $0.00, on a weighted average diluted shares of 505.8 million, compared to fully diluted earnings per share of $0.03 and a weighted average diluted shares of 454.2 million in the comparable quarter of the prior year. The increase in common shares outstanding is primarily due to conversion of preferred shares into common shares during the last 12 months.
Jerry Treppel, Chairman and CEO of Elite commented, "Our plan to increase revenues from product sales, which are inherently more stable and predictable than a milestone based revenue stream continues apace. We are in active discussions with our phentermine API supplier and are hopeful that a resolution can be reached, although we cannot predict if or when this might occur. We have manufactured larger batches of product in our new facility and begun limited packaging operations as well. We continue to move forward with the development of our abuse-resistant opioid products even as others in the field continue to have problems."
The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Thursday, November 15, 2012 at 10:00 AM EST. Company executives will also conduct a question and answer session following their remarks.
To access the conference call:
Domestic callers: (800) 346-7359
International callers: (973) 528-0008
Conference Entry Code: 98840
A digital telephone replay will be available approximately one hour after the conclusion of the call for two weeks until November 29, 2012 by dialing:
Domestic callers: (800) 332-6854
International callers: (973) 528-0005
Conference entry code: 98840
|ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
| September 30, |
| March 31, |
|Cash and cash equivalents||$ 207,343||$ 668,407|
|Accounts receivable (net of allowance for doubtful accounts of -0- and -0-, respectively)||562,943||396,847|
|Inventories (net of reserve of $93,338 and $93,338, respectively)||480,735||304,882|
|Prepaid expenses and other current assets||112,711||127,704|
|Total Current Assets||1,363,732||1,497,840|
|PROPERTY AND EQUIPMENT, net of accumulated depreciation of $4,888,414 and $4,659,670, respectively||4,172,280||4,284,786|
|INTANGIBLE ASSETS – net of accumulated amortization of $-0- and $-0--, respectively||666,163||642,848|
|Investment in Novel Laboratories, Inc.||3,329,322||3,329,322|
|Restricted cash – debt service for EDA bonds||274,031||280,585|
|EDA bond offering costs, net of accumulated amortization of $100,429 and $93,339, respectively||254,023||261,423|
|Total Other Assets||3,871,690||3,886,243|
|TOTAL ASSETS||$ 10,073,865||$10,311,717|
|LIABILITIES AND STOCKHOLDERS' DEFICIT|
|EDA bonds payable||$ 3,385,000||$ 3,385,000|
|Short term loans and current portion of long-term debt||206,636||13,316|
|Accounts payable and accrued expenses||1,128,346||1,066,494|
|Deferred revenues – current||13,333||13,333|
|Preferred share derivative interest payable||28,760||70,966|
|Total Current Liabilities||4,762,075||4,549,109|
|LONG TERM LIABILITIES|
|Other long term liabilities||89,497||87,404|
|Derivative liability – preferred shares||11,917,323||8,506,106|
|Derivative liability – warrants||14,947,419||11,987,222|
|Total Long Term Liabilities||27,113,128||20,746,290|
|Common stock – par value $0.001, Authorized 690,000,000 shares Issued and outstanding – 349,664,279 shares and 331,649,728 shares, respectively||349,664||331,650|
|Treasury stock at cost (100,000 common shares)||(306,841)||(306,841)|
|TOTAL STOCKHOLDERS' DEFICIT||(21,801,338)||(14,983,682)|
|TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT||$ 10,073,865||$10,311,717|
|ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|THREE MONTHS ENDED||SIX MONTHS ENDED|
|September 30,||September 30,|
|Manufacturing Fees||$ 466,020||$ 78,294||$ 845,716||$ 677,733|
|Royalties & Profit Splits||154,168||100,069||282,663||410,000|
|Lab Fee Revenues||14,329||95,769||84,693||176,275|
|COSTS OF REVENUES||479,631||76,331||933,995||501,700|
|Research and Development||228,475||198,212||425,357||643,709|
|General and Administrative||401,174||476,897||766,135||801,494|
|Non-cash compensation through issuance of stock options||15,133||6,113||21,246||12,226|
|Depreciation and Amortization||25,372||108,181||67,370||233,115|
|Total Operating Expenses||670,154||789,403||1,280,108||1,690,544|
|(LOSS) FROM OPERATIONS||(515,268)||(591,602)||(1,001,031)||(928,136)|
|OTHER INCOME / (EXPENSES)|
|Interest expense, net||(61,247)||(57,931)||(119,784)||(115,301)|
|Change in fair value of warrant derivatives||2,093,653||10,497,037||(2,995,081)||(3,086,393)|
|Change in fair value of preferred share derivatives||(187,383)||4,196,187||(4,830,866)||(12,414,600)|
|Interest expense attributable to preferred share derivatives||(28,823)||(124,370)||(83,901)||(267,175)|
|Discount in Series E issuance attributable to beneficial conversion features||(250,000)||---||(437,500)||---|
|Total Other Income / (Expense)||1,566,200||14,510,923||(8,467,132)||(15,883,469)|
|INCOME (LOSS) BEFORE PROVISION FOR INCOME TAXES||1,050,932||13,919,321||(9,468,163)||(16,811,605)|
|PROVISION FOR INCOME TAXES||1,023||---||4,023||2,500|
|NET INCOME (LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS||$ 1,049,909||$ 13,919,321||$ (9,472,186)||$ (16,814,105)|
|NET (LOSS) PER SHARE|
|Basic||$ 0.00||$ 0.06||$ (0.03)||$ (0.07)|
|Diluted||$ 0.00||$ 0.03||$ (0.03)||$ (0.07)|
|WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING|
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Elite has three commercial products being sold through a partner, one product produced for partners under contract manufacturing agreements, two additional products approved and pending launch, and three products under review, pending approval by the FDA. Elite's lead pipeline products include abuse resistant opioids utilizing the company's patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also has partnered with Mikah Pharma to develop a new product, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
The Elite Pharmaceuticals, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8737
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements These risks and other factors, including, without limitation, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Company's ability to operate as a going concern, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements.
Source:Elite Pharmaceuticals, Inc.