Revenues Increase by 35%, Product Development Accelerating
Conference Call Scheduled for Tuesday, July 1 at 12:00 PM EDT
NORTHVALE, N.J., June 30, 2014 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (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, 2014 ("Fiscal 2014").
Consolidated revenues were $4.6 million for the fiscal year, an increase of $1.2 million or approximately 35% over consolidated revenues for the prior year. During the fiscal year, Elite launched 3 new products, acquired 12 approved ANDA's, and saw strong and sustained growth in its line of commercial generic products. This marks the second consecutive year in which Elite achieved revenue growth in excess of $1 million.
During Fiscal 2014, Elite continued to expand and accelerate the development of its abuse resistant opioid technology, successfully completing a bio equivalence study, initiating a second bioequivalence study and a human abuse liability study and securing additional patents in the U.S. and internationally. As a result, product development costs increased from less than $1 million in the prior year to almost $4 million in Fiscal 2014. Elite expects to file the first of its range of abuse resistant opioid products by the end of calendar 2014.
Elite's balance sheet was also its strongest on record, reporting a working capital surplus of $3.8 million, the first working capital surplus in 5 years. Based on the strength of its balance sheet, combined with the growth in commercial operations and access to significant financing, management determined that Elite is sufficiently capitalized to operate as a going concern. Elite's independent auditors agreed with this determination, and have issued an unqualified opinion without a going concern paragraph. This is the first audit opinion without a going concern paragraph since 2002.
Nasrat Hakim, CEO of Elite commented, "Fiscal 2014 will be known as the year of Elite's turnaround. We successfully completed a bioequivalence study for ELI-200, initiated other human trials, and are well positioned to file the first of our abuse resistant opioid products by the end of this year. We have emerged as one of the leaders in the development of abuse deterrent opioids. In addition, we launched three new generic products and acquired twelve additional generic products, which we expect to provide a stable and growing foundation of revenues to sustain us on an ongoing basis. I want to thank and congratulate the entire Elite team for the spectacular accomplishments during Fiscal 2014, on which we continue to build and move forward."
The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Tuesday, July 1, 2014 at 12 Noon EDT. 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 approximately one hour after the conclusion of the call for two weeks until July 15, 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 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 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.
Source:Elite Pharmaceuticals, Inc.