BUENA, N.J., July 24, 2014 /PRNewswire/ -- IGI
Laboratories, Inc. (NYSE MKT: IG), a New
Jersey based specialty generic drug development and
manufacturing company, announced its financial results for the
second quarter ended June 30,
2014.
Second Quarter 2014 Highlights
- Total revenues of $6.5 million in
the second quarter of 2014, an increase of 70% over the same
quarter in 2013
- Total revenues of $13.3 million
for the six months ended June 30,
2014, an increase of 78% over the same period in 2013
- Total revenues generated from the sale of IGI label generic
topical pharmaceutical products for the three and six months ended
June 30, 2014 were $3.4 million, and $6.3
million, respectively, increases of 146% and 127% over the
same periods in 2013, respectively
- Gross margin increased to 43% for the six months ended
June 30, 2014 from 30% in the same
period of 2013
- IGI filed five Abbreviated Drug Applications, or ANDAs, with
the U.S. Food and Drug Administration (FDA) in the second quarter
of 2014
- IGI filed an additional ANDA, under a joint development
agreement with Impax Laboratories, Inc. in June 2014
- IGI received its tentative approval from the FDA for an ANDA
for diclofenac sodium 1.5% topical solution, and executed an
agreement to enable the company to launch the product in
March 2015 after final FDA
approval
- Net loss was $0.3 million in the
second quarter of 2014, compared to a net loss of $0.4 million in the same period in 2013
- Net loss was $0.2 million and
$0.7 million for the six months ended
June 30, 2014 and 2013,
respectively
- Net loss for the six months ended June
30, 2014 was impacted by the Company's decision to increase
research and development costs to $3.4
million, an increase of 132% over the same period in
2013
- On June 27, 2014, IGI announced
the pricing of their underwritten public offering of 4,650,000
shares of its common stock at a price to the public of $5.00 per share. Subsequently on
July 2, 2014, IGI, after giving
effect to the exercise of the over-allotment option, sold an
aggregate of 5,347,500 shares of common stock in the offering at a
public offering price of $5.00 per
share. The net proceeds of the offering were approximately
$25.2 million
- On June 30, 2014 IGI was added to
the Russell 3000 Index
IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "The extensive
list of accomplishments by the IGI team in the second quarter
represents our continued focus on executing our business
plan. We filed six ANDAs in the first few weeks of June,
including one under a joint development agreement with Impax
Laboratories, Inc. We received tentative approval of our ANDA
for diclofenac sodium 1.5% topical solution in May, and we should
be ready to launch the product in March
2015, after final FDA approval. As of today, we have
seventeen ANDAs pending at the FDA, with an addressable market of
over $465 million, and four
additional ANDAs which we have filed with three of our
pharmaceutical partners under joint development agreements.
On the financial front, we increased total revenue 70% over the
same quarter last year, and improved margins to end the second
quarter of 2014 with a gross margin of 45%, compared to 30% one
year ago. We continue to expect to file at least ten ANDAs in
2014, and we have accelerated our R&D efforts in order to meet
our commitments." Mr. Grenfell-Gardner continued, "We
continue to expect revenue to increase between 40% and 45% over
2013. We are committed to profitability for the year ended
December 31, 2014, even though we
plan to at least double our spending in research and development in
2014 over 2013."
The Company will hold a conference call at 4:15 pm ET on Thursday,
July 24, 2014 to discuss the 2nd quarter 2014 results.
The Company invites you to listen to the call by dialing
1-877-870-4263. International participants should call
1-412-317-0790. Canadian participants should call
1-855-669-9657. Participants should ask to be joined into the
IGI Laboratories, Inc. call.
This call is being webcast by MultiVu (a PR Newswire Company)
and can be accessed in the Investor Relations Section of IGI's
website at www.igilabs.com.
IGI LABORATORIES,
INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands,
except shares and per share information)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
Six months ended
June 30,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$ 6,021
|
|
$ 3,706
|
|
$
12,520
|
|
$
7,174
|
Research and development
income
|
437
|
|
109
|
|
750
|
|
268
|
Licensing, royalty and other
revenue
|
25
|
|
5
|
|
66
|
|
62
|
Total revenues
|
6,483
|
|
3,820
|
|
13,336
|
|
7,504
|
|
|
|
|
|
|
|
|
Costs and
Expenses:
|
|
|
|
|
|
|
|
Cost of
sales
|
3,580
|
|
2,673
|
|
7,567
|
|
5,248
|
Selling, general and
administrative expenses
|
1,156
|
|
706
|
|
2,438
|
|
1,386
|
Product development and
research expenses
|
2,028
|
|
805
|
|
3,393
|
|
1,463
|
Total costs and expenses
|
6,764
|
|
4,184
|
|
13,398
|
|
8,097
|
Operating
loss
|
(281)
|
|
(364)
|
|
(62)
|
|
(593)
|
Interest expense and
other, net
|
(64)
|
|
(39)
|
|
(116)
|
|
(67)
|
|
|
|
|
|
|
|
|
Net
loss
|
$
(345)
|
|
$
(403)
|
|
$
(178)
|
|
$
(660)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
loss per share
|
($0.01)
|
|
($0.01)
|
|
$0.00
|
|
($0.02)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares of common stock outstanding:
|
|
|
|
|
|
|
|
Basic and
diluted
|
47,107,094
|
|
43,206,016
|
|
46,967,688
|
|
43,070,335
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IGI LABORATORIES,
INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
For the six months
ended June 30, 2014 and 2013
|
(in
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
$
(178)
|
|
$
(660)
|
Non-cash expenses
|
|
|
|
|
944
|
|
389
|
Changes in operating assets
and liabilities
|
|
|
|
|
(1,236)
|
|
(680)
|
|
|
|
|
|
|
|
|
Net cash used in
operating activities
|
|
|
|
|
(470)
|
|
(951)
|
|
|
|
|
|
|
|
|
Net cash used in
investing activities
|
|
|
|
|
(312)
|
|
(1,575)
|
|
|
|
|
|
|
|
|
Net cash provided by
financing activities
|
|
|
|
|
443
|
|
1,303
|
|
|
|
|
|
|
|
|
Net decrease in cash
and cash equivalents
|
|
|
|
|
(339)
|
|
(1,223)
|
Cash and cash
equivalents at beginning of period
|
|
|
|
|
2,101
|
|
2,536
|
Cash and cash
equivalents at end of period
|
|
|
|
|
$
1,762
|
|
$
1,313
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IGI LABORATORIES,
INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in thousands,
except share and per share information)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
June 30,
2014
|
|
December
31,
|
|
|
|
|
2013*
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
$
1,762
|
|
$
2,101
|
Accounts receivable,
net
|
|
|
|
|
5,251
|
|
4,947
|
Inventories
|
|
|
|
|
2,723
|
|
2,869
|
Prepaid expenses and other
receivables
|
|
|
|
|
814
|
|
641
|
Total current assets
|
|
|
|
|
10,550
|
|
10,558
|
Property, plant and
equipment, net
|
|
|
|
|
2,750
|
|
2,623
|
Product acquisition
costs, net
|
|
|
|
|
1,706
|
|
1,766
|
Restricted cash, long
term
|
|
|
|
|
54
|
|
54
|
License fee,
net
|
|
|
|
|
150
|
|
200
|
Debt issuance costs,
net
|
|
|
|
|
53
|
|
69
|
Other
|
|
|
|
|
355
|
|
157
|
Total assets
|
|
|
|
|
$
15,618
|
|
$
15,427
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
|
$
2,246
|
|
$
1,523
|
Accrued expenses
|
|
|
|
|
2,234
|
|
2,915
|
Deferred income,
current
|
|
|
|
|
135
|
|
768
|
Capital lease obligation,
current
|
|
|
|
|
11
|
|
15
|
Total current liabilities
|
|
|
|
|
4,626
|
|
5,221
|
|
|
|
|
|
|
|
|
Note payable,
bank
|
|
|
|
|
3,000
|
|
3,000
|
Other long term
liabilities
|
|
|
|
|
8
|
|
15
|
Total liabilities
|
|
|
|
|
7,634
|
|
8,236
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
Common stock, $0.01 par
value, 60,000,000 shares authorized; 47,129,621 and 46,748,575
shares issued and outstanding as of June 30, 2014 and December 31,
2013, respectively
|
|
|
491
|
|
487
|
Additional paid-in
capital
|
|
|
|
|
52,508
|
|
51,541
|
Accumulated
deficit
|
|
|
|
|
(45,015)
|
|
(44,837)
|
Total stockholders' equity
|
|
|
|
|
7,984
|
|
7,191
|
Total liabilities and stockholders' equity
|
|
|
|
|
$
15,618
|
|
$
15,427
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*Derived from the
audited December 31, 2013 financial statements
|
|
|
|
|
|
|
|
|
About IGI Laboratories, Inc.
IGI Laboratories is a specialty generic drug development and
manufacturing company. Our mission is to be a leading player in the
specialty generic prescription drug market.
IGI Laboratories, Inc. "Safe Harbor" Statement under the Private
Securities Litigation Reform Act of 1995. 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 set forth under the caption "Risk Factors" in IGI
Laboratories, Inc.'s most recent Annual Report on Form 10-K and
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 global political,
economic, business, competitive, market and regulatory factors; and
our inability to complete successfully future product acquisitions.
IGI Laboratories, Inc. does not undertake any obligation to update
any forward-looking statements contained in this document as a
result of new information, future events or otherwise.
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SOURCE IGI Laboratories, Inc.