NORTHVALE, N.J., Feb. 14, 2013 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (OTCBB:ELTP), a specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations, abuse-resistant opioid formulations, and the manufacturing of generic pharmaceuticals, announced results for the fiscal second quarter ended December 31, 2012.
Consolidated revenues were $0.7 million for the quarter, an increase of 31% when compared to the comparable quarter of the prior year. This increase is the result of the continuing growth of the new product revenue streams that have been created within the last eighteen months.
Consolidated loss from operations was $(0.3 million) for this quarter, compared with a loss from operations $(0.4 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 $9.4 million, compared to a GAAP net income of $8.8 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 $0.03, on a weighted average of 350.2 million common shares outstanding, compared to a basic earnings per common share of $0.03 and a weighted average common shares outstanding of 262.1 million in the comparable quarter of the prior year. Fully diluted earnings per share was $0.02, on a weighted average diluted shares of 486.2 million, compared to fully diluted earnings per share of $0.02 and a weighted average diluted shares of 427.0 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.
During the quarter, Elite also resolved the raw material supply issues related to its Phentermine product line which caused delays in the launch of its recently approved Phentermine 15mg and Phentermine 30mg capsules. In addition, subsequent to the end of the quarter, Elite received FDA approval for a third product, Naltrexone 50mg tablets. These products, when launched, represent continued expansion of Elite's product lines and are expected to contribute to further growth in revenue streams.
Jerry Treppel, Chairman and CEO of Elite commented, "The Company continues to progress towards its goal of becoming break-even on an operating cash flow basis exclusive of any clinical trials required for our abuse-resistant opioid products. We expect this to occur in the next quarter or two. We are in the process of finalizing and scaling up the formulation of one of our abuse-resistant opioid products so as to commence human trials. As we have stated before, we are in the process of seeking additional capital to finance these trials. All in all, it was another excellent quarter of progress for Elite."
The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Tuesday, February 19, 2013 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 March 5, 2013 by dialing: |
| Domestic callers: (800) 332-6854 |
| International callers: (973) 528-0005 |
| Conference entry code: 98840 |
The financial statements can be viewed in Elite's Quarterly Report on Form 10-Q at http://www.elitepharma.com/sec_filings.asp.
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 currently being sold, three additional products approved and soon to be launched, and one additional product 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 provides contract manufacturing for Actavis and Ascend Laboratories (previously a subsidiary of ThePharmaNetwork and now a subsidiary of Alkem Laboratories Ltd.) and 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.