BUENA, N.J., May 27, 2015 /PRNewswire/ -- IGI
Laboratories, Inc. (NYSE MKT: IG), a New
Jersey-based specialty generic pharmaceutical company, today
updated its full year 2015 financial guidance and business
outlook.
Second Quarter and Full Year 2015 Updated Financial
Guidance
- Total revenues for the three months ended June 30, 2015 are still expected to be between
$7.0 and $8.0 million. The
Company expects sequential improvement quarter over quarter in
total revenue for the remainder of the year, and therefore expects
total revenue between $35.0 and $40.0
million for the year ended December
31, 2015.
- Due to the effect of a price decline in one product in the
second quarter of 2015, the Company expects gross margin in the
second quarter to approximate 34% to 35%. The Company
anticipates sequential improvement in gross margin quarter over
quarter for the remainder of the year, and therefore expects gross
margin of 43% to 50% for the year ended December 31, 2015.
- The Company continues to expect to submit an additional four
ANDAs before June 30, 2015, and
intends to have submitted a total of 20 ANDAs by the end of
2015. In order to complete all of the development work
required for the 2015 filings, the Company expects to spend between
$13 and $14.5 million in research and
development by the end of 2015.
- As a result of the expected sequential increase in total
revenue in the third and fourth quarter of 2015, the Company
intends to return to a break-even operating margin in the fourth
quarter of 2015.
IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "We believe that
2015 is the year dedicated to building our foundation, focused on
the advancement of our research and development
pipeline. While our econazole product has been a significant
part of our revenue in the last few quarters, the recent changes in
the market for this product require us to issue adjusted guidance
for 2015. We continue to monitor and evaluate the markets of
all of our products to maintain our competitive positions. I
believe we are well positioned to gain incremental market share in
the coming periods."
"Our long-term strategy continues to focus on the creation of a
diversified product portfolio, built through our in-house R&D
group, as well as through inorganic business development
opportunities – all aligned with our topical, injectable, complex
and ophthalmic, or TICO, strategy. We continue to make good
progress on the first few of the injectable and ophthalmic product
projects that we acquired last year, as well as on our first
505(b)2 topical projects," Mr. Grenfell-Gardner continued. "As of
today, our research and development team has twenty-four ANDAs
pending with the FDA. Based on March
2015 IMS Health data, the addressable market for our
pipeline of twenty-four ANDAs, pending approval by the FDA, is
estimated at $747 million.''
Mr. Grenfell-Gardner concluded, "We are now seeing an increased
pace of communications from the FDA for our ANDA filings submitted
after October 1, 2014. Therefore, we
believe it is important to complete the projects already in
progress for 2015, which will bring our total number of targeted
ANDA filings for the year to at least twenty. Even with a
planned spend on research and development of up to $14.5 million for 2015, which is more than double
our R&D investment in 2014, we expect that we would still
return to a break-even operating margin by the fourth quarter of
this year."
About IGI Laboratories, Inc.
IGI Laboratories is a
specialty generic pharmaceutical company. Our mission is to be a
leading player in the specialty generic prescription drug
market.
Forward Looking Statements
This press release includes
certain "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to, plans,
objectives, expectations and intentions, and other statements
contained in this press release that are not historical facts and
statements identified by words such as "will," "believe," "target,"
"estimated," "continue" or words of similar meaning. These
statements are based on our current beliefs or expectations and are
inherently subject to various risks and uncertainties, including
those included from time to time in the "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and
Results of Operations" sections in our most recent Annual Report on
Form 10-K, as updated by Quarterly Reports on Form 10-Q and other
reports we file with the Securities and Exchange Commission. Actual
results may differ materially from these expectations. Factors that
could cause actual results to differ materially from these
expectations include, but are not limited to: our inability to meet
current or future regulatory requirements in connection with
existing or future ANDAs; our inability to achieve profitability;
our failure to obtain FDA approvals as anticipated; our inability
to execute and implement our business plan and strategy; the
potential lack of market acceptance of our products; our inability
to protect our intellectual property rights; changes in and the
impact of global political, economic, business, competitive,
market, regulatory and other factors; and our inability to complete
successfully future product acquisitions. We assume no
obligation to update any forward-looking statements or information,
which speak as of their respective dates.
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SOURCE IGI Laboratories, Inc.