NORTHVALE, N.J., June 21, 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 fiscal year ended March 31, 2013.
Consolidated revenues were $3.4 million for the fiscal year, an increase of $1.0 million or approximately 40% over consolidated revenues for the prior year. Revenues for the quarter ended March 31, 2013, were exceptionally strong, totaling $1.5 million, the highest quarterly revenue level in corporate history, 131% above quarterly revenues for the comparable period of the prior year. The large increases in revenues are the result of the successful launch and strong growth in new product revenues which have mostly been created during the past 18 months.
Since the end of the fiscal year, Elite launched two new products, Phentermine 15mg capsules and Phentermine 30mg capsules, both being distributed under license by TAGI Pharma. These new products did not generate revenues during the fiscal year ended March 31, 2013, but are generating revenues currently. Shortly, Elite will begin manufacture of naltrexone 50 mg tablets, a recently approved ANDA whose revenues are not represented in Elite's fiscal year 2013 results.
Elite's operations incurred a $1.9 million negative cash flow, due in large part to the financing of a $1.4 million increase inventory and receivables generated by the rapid increase in revenues.
Consolidated loss from operations was $1.6 million, and GAAP net income, including non-cash income relating to the accounting treatment of preferred share and warrant derivatives was $1.5 million. Basic earnings per share were $0.00 on a weighted average 349.1 million common shares outstanding. Fully diluted loss per share was $(0.00), on a weighted average of 526.9 million shares outstanding on a fully diluted basis.
Jerry Treppel, Chairman and CEO of Elite commented, "It has been a remarkable year for Elite. We launched new products, substantially increased our revenues, and lowered our operating losses. Most importantly, I can now tell you that we expect our first commercially scaled-up, abuse-resistant opioid product to enter human pilot studies later this year. We have also conducted work on another abuse-resistant opioid product. We have also received FDA feedback on clinical protocols for the extended release brompheniramine product and have filed a Citizen Petition regarding the extended release brompheniramine/pseudoephedrine product, which, if successful, would put this product in a position to also begin clinical trials and eventually secure approvals for bringing these products on to the market. The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Monday, June 24, 2013 at 11:00 AM 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 July 8, 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 Annual Report on Form 10-K 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 five commercial products currently being sold, an additional product approved and soon to be launched, and one additional product 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 Mikah Pharma and 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, 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.