Elite Pharmaceuticals, Inc. Reports Financial Results for the Fiscal Year Ended March 31, 2014
June 30 2014 - 2:05PM
Revenues Increase by 35%, Product
Development Accelerating
Conference Call Scheduled for Tuesday,
July 1 at 12:00 PM EDT
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.
CONTACT: For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
www.elitepharma.com
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