NORTHVALE, N.J., Aug. 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 first quarter of fiscal year 2014 ended June 30, 2013.
Manufacturing and profit split revenues comprised almost all of Elite's quarterly revenues and totaled $717k for the quarter, an increase of 41% from the prior year. This growth is attributed to the launch of two new products during the quarter, Phentermine 15mg and 30mg capsules, combined with strong year-on-year growth of the Elite's Hydromorphone 8mg tablets and contract manufactured Methadone 10mg product lines.
Consolidated loss from operations was $975k, and GAAP net income, including non-cash income related to the accounting treatment of preferred share and warrant derivatives was $922k. Basic loss per share were $(0.00) on a weighted average 388.0 million common shares outstanding. Fully diluted earnings per share were $0.00, on a weighted average of 580.4 million shares outstanding on a fully diluted basis. Elite's operations incurred a $355k negative cash flow, due in large part to the cost of significantly expanded product development activities.
Subsequent to the end of the quarter, Elite began the manufacture of naltrexone 50mg tablets, a recently approved ANDA and also acquired 13 new products, consisting of 1 product approved for manufacture at Elite's facilities, an additional 11 products which are approved by the FDA and require manufacturing transfer to Elite's facility and 1 product filed with and pending approval with the FDA. These products did not generate revenues during the quarter, but some are expected to be phased in to commercial operations and begin generating revenues and contributions over the course of the next twelve months.
"We are very excited with the recent addition of thirteen products to Elite's pipeline. Bringing these products on line as quickly as possible is one of our top priorities," commented Nasrat Hakim, President and CEO of Elite. "In parallel to the expansion of our generic product lines, we are moving forward with the initial clinical trials of our abuse resistant technology and I am very encouraged by the progress made to date."
The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Thursday, August 15, 2013 at 3:00 PM EDT. 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 August 29, 2013 by dialing:
| Domestic callers: (800) 332-6854 |
| International callers: (973) 528-0005 |
| Conference entry code: 9884015 |
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.