Revenues Increase 8.5% Over Prior Quarter
Conference Call Scheduled for Wednesday, February 18 at 11:00 AM EST
NORTHVALE, N.J., Feb. 17, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, announced results for the third quarter of fiscal year 2015 ended December 31, 2014.
Consolidated revenues for the third quarter of Fiscal 2015 continued their upward trend, rising to $1.4 million, an increase of approximately 8.5% over consolidated revenues for the second quarter of Fiscal 2015. The third quarter revenues for this year were $0.3 million below revenues reported for the third quarter of the prior fiscal year due to a one-time $0.6 million milestone that occurred in the prior year third quarter. Revenues for the nine months ending December 31, 2014 were $3.8 million, an increase of 6% over revenues for the comparable period of the prior year, even with the one-time milestone being included in the prior year revenues. The increase in revenues is due to the continued growth and expansion of Elite's generic product lines.
Development of our proprietary abuse-deterrent opioid technology continues to be Elite's top priority. During the quarter, Elite invested an additional $2.3 million in clinical trials and other product development activities. During the first nine months of the fiscal year, Elite has invested a total of $9.9 million in product development, including successful completion of the human abuse liability study for ELI-200. Other development activities related to ELI-200 and Elite's other abuse-deterrent opioid products are also ongoing. Elite will provide an update on these development activities during the conference call.
"Once again, this quarter was better than the last, a trend that I expect to continue. The growth and expansion of Elite's generic product line, a key part of our strategy, continues on a steady path upward," commented Nasrat Hakim, President and CEO of Elite. "For ELI-200, Elite's first abuse-deterrent opioid product, we now have a clear path, and an efficacy study is expected to begin in mid-March upon receipt of FDA feedback on our protocol. We expect to file ELI-200 NDA in Q3 and therefore expect the NDA review by FDA to be completed by early 2016. In anticipation of the product launch, we are now expanding our manufacturing facility and adding capacity."
The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Wednesday, February 18, 2015 at 11:00 AM EST. Company executives will 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 on the company's website approximately one hour after the conclusion of the call for two weeks until March 4, 2015 or 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: www.elitepharma.com
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite has eight commercial products currently being sold, several additional approved products pending manufacturing site transfer an additional product under review pending approval by the FDA. Elite's lead pipeline products include abuse-deterrent 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 transfer, 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.