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02:43:32 EDT Tue 02 Sep 2014
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ELITE PHARMACEUTICALS INC
Symbol U : ELTP
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Elite Pharmaceuticals, Inc. Reports Financial Results for the Third Quarter of Fiscal Year 2014

2014-02-14 09:50 ET - News Release

Revenues Increase by 154%, Product Development Accelerating

Conference Call Scheduled for Tuesday, February 18 at 3:00 PM ET

NORTHVALE, N.J., Feb. 14, 2014 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (OTCBB:ELTP), a specialty pharmaceutical company dedicated to developing and commercializing opioid abuse deterrent formulations and the manufacturing of generic pharmaceuticals, announced results for the third quarter of fiscal year 2014 ended December 31, 2013.

Total revenues for the quarter ended December 31, 2013 were $1.7 million, an increase of 154% from the prior year. This increase is attributed to the combination of revenues being generated from an expanding product line, with three new products being launched this year so far, and strong year on year growth of Elite's Phentermine tablets, Hydromorphone and contract manufactured Methadone products launched in prior years. The 12 ANDA's acquired by Elite in August 2013 also started generating revenues during this quarter, with initial milestones being achieved pursuant to manufacturing and license agreement with Epic Pharma LLC and relating to these 12 ANDA's.

Consolidated quarterly loss from operations was $1.2 million, and GAAP net income, including non-cash income related to the accounting treatment of preferred share and warrant derivatives was a net loss of $1.1 million. Basic and diluted loss per share was $(0.00) on a weighted average 508.6 million common shares outstanding. Elite's operations incurred a $2.7 million negative cash flow for the nine months ended December 31, 2013, due in large part to the cost of significantly expanded product development activities.

Research and development costs for the quarter were $1.3 million, a year on year increase of almost $1.1 million and an increase $0.4 million from the September 2013 quarter. R&D costs were greater than the overall operating loss for a second consecutive quarter, providing clear indication of management's strong commitment to the development of its abuse resistant opioid products, and the accelerating activities in this area.

"Our goal is to create a strong commercial foundation to support Elite's development into a leader in the abuse resistant opioid market, and we have clearly demonstrated great strides toward this goal during the quarter," commented Nasrat Hakim, President and CEO of Elite. "We initiated human clinical trials of the first of our ART products, achieved the first milestones and revenues from the 12 ANDA's acquired in August, and our commercial generic products continue to perform well."

The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Tuesday, February 18, 2014 at 3:00 PM ET. 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 4, 2014 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 seven commercial products currently being sold, twelve additional approved products pending manufacturing site transfer and two additional 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 provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site, 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.

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, its ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, 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 Company's ability to obtain sufficient funding under the LPC Agreement or from other sources, 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.

CONTACT: For Elite Pharmaceuticals, Inc.
         Dianne Will, Investor Relations, 518-398-6222
         Dianne@elitepharma.com
         www.elitepharma.com

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