Elite Pharmaceuticals, Inc. Reports Financial Results for the Third Quarter of Fiscal Year 2014
15 February 2014 - 1:49AM
Revenues Increase by 154%, Product
Development Accelerating
Conference Call Scheduled for Tuesday,
February 18 at 3:00 PM ET
Elite Pharmaceuticals, Inc. (OTCBB:ELTP), a specialty
pharmaceutical company dedicated to developing and commercializing
opioid abuse deterrent formulations and the manufacturing of
generic pharmaceuticals, announced results for the third quarter of
fiscal year 2014 ended December 31, 2013.
Total revenues for the quarter ended December 31, 2013 were $1.7
million, an increase of 154% from the prior year. This increase is
attributed to the combination of revenues being generated from an
expanding product line, with three new products being launched this
year so far, and strong year on year growth of Elite's Phentermine
tablets, Hydromorphone and contract manufactured Methadone products
launched in prior years. The 12 ANDA's acquired by Elite in August
2013 also started generating revenues during this quarter, with
initial milestones being achieved pursuant to manufacturing and
license agreement with Epic Pharma LLC and relating to these 12
ANDA's.
Consolidated quarterly loss from operations was $1.2 million,
and GAAP net income, including non-cash income related to the
accounting treatment of preferred share and warrant derivatives was
a net loss of $1.1 million. Basic and diluted loss per share was
$(0.00) on a weighted average 508.6 million common shares
outstanding. Elite's operations incurred a $2.7 million negative
cash flow for the nine months ended December 31, 2013, due in large
part to the cost of significantly expanded product development
activities.
Research and development costs for the quarter were $1.3
million, a year on year increase of almost $1.1 million and an
increase $0.4 million from the September 2013 quarter. R&D
costs were greater than the overall operating loss for a second
consecutive quarter, providing clear indication of management's
strong commitment to the development of its abuse resistant opioid
products, and the accelerating activities in this area.
"Our goal is to create a strong commercial foundation to support
Elite's development into a leader in the abuse resistant opioid
market, and we have clearly demonstrated great strides toward this
goal during the quarter," commented Nasrat Hakim, President and CEO
of Elite. "We initiated human clinical trials of the first of our
ART products, achieved the first milestones and revenues from the
12 ANDA's acquired in August, and our commercial generic products
continue to perform well."
The Company will host a conference call to discuss the
results of operations and provide an update on recent business
developments on Tuesday, February 18, 2014 at 3:00 PM ET. 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 March 4, 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 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 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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