Revenues Increase by 83%, Product Development Accelerating
Conference Call Scheduled for Monday, November 18 at 3:00 PM ET
NORTHVALE, N.J., Nov. 14, 2013 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (OTCBB: ELTP ), a specialty pharmaceutical company dedicated to developing and commercializing oral abuse-resistant controlled release product formulations and the manufacturing of generic pharmaceuticals, announced results for the second quarter of fiscal year 2014 ended September 30, 2013.
Total revenues for the quarter ended September 30, 2013 were $1.2 million, an increase of 83% from the prior year. This growth is attributed to the recent launch of 3 new products, Naltrexone 50mg in the September quarter and Phentermine 15mg and 30mg capsules in the June quarter, combined with strong year-on-year growth of Elite's Phentermine 37.5mg tablets, Hydromorphone 8mg tablets and contract manufactured Methadone 10mg product lines.
Consolidated quarterly loss from operations was $0.7 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 $9.6 million. Basic and diluted loss per share was $(0.02) on a weighted average 422.0 million common shares outstanding. Elite's operations incurred a $1.3 million negative cash flow for the six months ended September 30, 2013, due in large part to the cost of significantly expanded product development activities.
Subsequent to the end of the quarter, Elite executed a manufacturing and license agreement with Epic Pharma LLC, wherein Elite grants manufacturing and distribution rights to Epic in relation to the 12 approved ANDA's acquired by Elite in August 2013. Epic will have exclusive licenses to 6 of these approved ANDA's and non-exclusive licenses to the remaining 6 approved ANDA's. Pursuant to this agreement, Elite will receive various milestone payments and profit splits from sales of these products. Elite expects this agreement to begin generating revenues during the quarter ended December 31, 2013.
"In addition to launching a new product and substantially increasing our revenues, we have set in motion several initiatives that will have significant impact on Elite's future," commented Nasrat Hakim, President and CEO of Elite. "During this quarter, we acquired 12 new approved products, greatly accelerated the development of our abuse resistant technology and are on schedule for clinical trials to begin this year."
The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Monday, November 18, 2013 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 December 2, 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 six commercial products currently being sold, an additional product approved and soon to be launched, eleven 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 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.
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.
For Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations, 518-398-6222 www.elitepharma.com
