updated 11/15/2010 4:47:58 PM ET 2010-11-15T21:47:58

NORTHVALE, N.J., Nov. 15, 2010 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (OTCBB:ELTP), a specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations, announced results for the fiscal second quarter ended September 30, 2010.

For the second quarter, consolidated revenues were $994,646, an increase of 28% compared with last year's second quarter, with substantially all revenues being derived from the manufacture, sale and lab services related to the Lodrane family of products.

Operating losses were reduced by 66% to $136,807 from last year's second quarter operating loss of $406,659. The significant decrease in operating losses represents the continuing efforts by management to increase manufacturing efficiency and reduce operating costs.

GAAP net income, including non-cash revenues and expenses relating to the accounting treatment of preferred share derivatives and the fair value of warrant derivatives, was $1,864,224, or $0.02 basic net income per share and $0.01 fully diluted net income per share.

Cash flow from operations was a positive $354,788 during the second quarter of fiscal 2011, compared to a negative operating cash flow of ($1,057,184) for last year's second quarter. The majority of the positive cash flow generated from operations during the quarter was from a licensing fee related to the previously disclosed marketing agreement with Precision Dose, Inc. Most of the cash flow generated from operations was re-invested during the quarter in the purchases, previously announced, of two approved ANDA's and one ANDA pending approval, as well as in the continued expansion and improvement of Elite's manufacturing facilities. Net cash flow for the quarter, inclusive of cash used in investing and financing activities, was a positive $15,666. Cash as of September 30, 2010 was $593,853.

The company is currently in discussions to license its once daily oxycodone product, ELI-154 to a European marketing partner and is progressing towards scale-up in the development of its abuse-resistant formulation of oxycodone, ELI-216.

Financial Statements 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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. Two of Elite's products, Lodrane 24® and Lodrane 24D®, are marketed by a partner, ECR Pharmaceuticals, for allergy treatment. Elite's lead pipeline products are novel sustained release oral formulations of oxycodone 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. Both products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are in late-stage development. Elite, with partners, also has an ANDA filed with the FDA for a generic equivalent of a pain product and has a generic gastrointestinal drug product in clinical development. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.

This news release contains forward-looking statements, including those related to the preliminary nature of the clinical program results and the potential for further product development, that involve known and unknown risks, delays, uncertainties and other factors not under the control of Elite, which may cause actual results, performance or achievements of the companies to be materially different from the results, performance or other expectations implied by these forward-looking statements. In particular, because substantial future testing will be required prior to approval, the results described above may not be supported by additional data or by the results of subsequent trials. These risks and other factors, including the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, and intellectual property protections and defenses, are discussed in Elite's filings with the Securities and Exchange Commission such as the 10K, 10Q and 8K reports. Elite undertakes no obligation to update any forward-looking statements.

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