BUENA, N.J., Oct. 23, 2014 /PRNewswire/ -- IGI Laboratories,
Inc. (NYSE MKT: IG), a New Jersey
based specialty generic pharmaceutical company, announced its
financial results for the third quarter ended September 30, 2014.
Third Quarter 2014 Highlights
- Total revenues of $6.7 million in
the third quarter of 2014, an increase of 67% over the same quarter
in 2013
- Total revenues of $20.0 million
for the nine months ended September 30,
2014, an increase of 74% over the same period in 2013
- Total net revenues generated from the sale of IGI-label generic
topical pharmaceutical products for the three and nine months ended
September 30, 2014 were $3.0 million and $9.3
million, respectively, increases of 117% and 123% over the
same periods in 2013, respectively
- Total net revenues from IGI-label generic products for the
third quarter ended September 30,
2014 included a required adjustment to our chargeback
accrual of $3.8 million related to
price increases for IGI's econazole nitrate cream 1% product, which
took effect in September 2014
- Gross margin increased to 42% for the nine months ended
September 30, 2014 from 31% for the
same period in 2013
- Net loss was $0.2 million in the
third quarter of 2014, compared to a net loss of $0.1 million for the same period in 2013
- Net loss was $0.4 million and
$0.8 million for the nine months
ended September 30, 2014 and 2013,
respectively
- Net loss included research and development costs of
$5.0 million and $2.1 million in the nine months ended
September 30, 2014 and 2013,
respectively
- On July 2, 2014, IGI sold
5,347,500 shares of its common stock, after giving effect to the
exercise in full by the underwriters of their over-allotment
option, in an underwritten offering at a price to the public of
$5.00 per share. The net
proceeds of the offering to IGI were approximately $25.2 million
- On September 24, 2014, IGI
acquired eighteen former AstraZeneca products, seventeen of which
were injectable products
- On September 30, 2014, IGI
acquired two ophthalmic products from Valeant, in addition to the
exclusive right to acquire three additional injectable products
from Valeant
IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "At the
beginning of 2014, we said this would be a year of transformation
for IGI, and as we end the third quarter, we believe that we have
delivered on that promise. The two acquisitions we completed
at the end of September are initial drivers of a broader strategy
to become a leader in the specialty generic pharmaceutical drug
market. While we will continue expanding our reach into the topical
market, we will also pursue targeted opportunities in the
injectable, complex and ophthalmic generic pharmaceutical
markets. We call this our TICO strategy, as it
represents our strategic focus to leverage our assets and expertise
across the topicals, injectables, complex and ophthalmic
spaces. As of today, we have seventeen ANDAs pending at the
FDA, with an addressable market of over $465
million as of August 2014, and
four additional ANDAs, which we have filed with three of our
pharmaceutical partners under joint development agreements."
Mr. Grenfell-Gardner continued, "We increased total revenue by 67%
over the same quarter last year, and improved margins to end
the third quarter of 2014 with a gross margin of 42%, which
included our adjustment to net revenue of just over $3.8 million related to price protection for our
customers after our price increase for econazole nitrate cream 1%
took effect in September. We expect to be on schedule to file
at least ten ANDAs by the end of 2014. We forecast net
revenue for 2014 to be $31.5 to $33.0
million, gross margin for 2014 to approximate 50% and net
income for the full year to range between $2.0 and $3.0 million."
The Company will hold a conference call at 4:15 pm ET on Thursday,
October 23, 2014 to discuss the third quarter 2014
results.
The Company invites you to listen to the call by dialing
1-888-346-3479. International participants should call
1-412-902-4260. 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.
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.
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.
IGI LABORATORIES,
INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands,
except shares and per share information)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$ 6,005
|
|
$ 3,950
|
|
$ 18,525
|
|
$ 11,124
|
Research and development
income
|
635
|
|
10
|
|
1,385
|
|
278
|
Licensing, royalty and other
revenue
|
28
|
|
35
|
|
95
|
|
97
|
Total revenues
|
6,668
|
|
3,995
|
|
20,005
|
|
11,499
|
|
|
|
|
|
|
|
|
Costs and
Expenses:
|
|
|
|
|
|
|
|
Cost of
sales
|
4,036
|
|
2,684
|
|
11,603
|
|
7,932
|
Selling, general and
administrative expenses
|
1,124
|
|
692
|
|
3,563
|
|
2,078
|
Product development and
research expenses
|
1,652
|
|
661
|
|
5,045
|
|
2,123
|
Total costs and expenses
|
6,812
|
|
4,037
|
|
20,211
|
|
12,133
|
Operating
loss
|
(144)
|
|
(42)
|
|
(206)
|
|
(634)
|
Interest expense and
other, net
|
(58)
|
|
(53)
|
|
(174)
|
|
(121)
|
|
|
|
|
|
|
|
|
Net
loss
|
$
(202)
|
|
$
(95)
|
|
$
(380)
|
|
$
(755)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted loss per share
|
($0.00)
|
|
($0.00)
|
|
($0.01)
|
|
($0.02)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares of common stock outstanding:
|
|
|
|
|
|
|
|
Basic and
diluted
|
52,457,938
|
|
43,395,980
|
|
48,811,328
|
|
39,510,540
|
IGI LABORATORIES,
INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
For the nine
months ended September 30, 2014 and 2013
|
(in
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
$ (380)
|
|
$ (755)
|
Non-cash expenses
|
|
|
|
|
1,244
|
|
671
|
Changes in operating assets
and liabilities
|
|
|
|
|
(1,894)
|
|
(1,307)
|
|
|
|
|
|
|
|
|
Net cash used in
operating activities
|
|
|
|
|
(1,030)
|
|
(1,391)
|
|
|
|
|
|
|
|
|
Net cash used in
investing activities
|
|
|
|
|
(3,077)
|
|
(2,049)
|
|
|
|
|
|
|
|
|
Net cash provided by
financing activities
|
|
|
|
|
25,254
|
|
2,306
|
|
|
|
|
|
|
|
|
Net increase
(decrease) in cash and cash equivalents
|
|
|
|
|
21,147
|
|
(1,134)
|
Cash and cash
equivalents at beginning of period
|
|
|
|
|
2,101
|
|
2,536
|
Cash and cash
equivalents at end of period
|
|
|
|
|
$23,248
|
|
$1,402
|
IGI LABORATORIES,
INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in thousands,
except share and per share information)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
September 30,
2014
|
|
December
31,
2013*
|
ASSETS
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$23,248
|
|
$ 2,101
|
Accounts receivable,
net
|
|
|
6,369
|
|
4,947
|
Inventories
|
|
|
3,218
|
|
2,869
|
Prepaid expenses and other
receivables
|
|
|
1,011
|
|
641
|
Total current assets
|
|
|
33,846
|
|
10,558
|
Property, plant and
equipment, net
|
|
|
3,169
|
|
2,623
|
Product acquisition
costs, net
|
|
|
10,135
|
|
1,766
|
Restricted cash, long
term
|
|
|
54
|
|
54
|
License fee,
net
|
|
|
125
|
|
200
|
Debt issuance costs,
net
|
|
|
45
|
|
69
|
Other
|
|
|
143
|
|
157
|
Total assets
|
|
|
$47,517
|
|
$15,427
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
|
$ 2,143
|
|
$ 1,523
|
Accrued expenses
|
|
|
3,359
|
|
2,915
|
Payable for product
acquisition costs
|
|
|
6,000
|
|
-
|
Deferred income,
current
|
|
|
34
|
|
768
|
Capital lease obligation,
current
|
|
|
131
|
|
15
|
Total current liabilities
|
|
|
11,667
|
|
5,221
|
|
|
|
|
|
|
Note payable,
bank
|
|
|
2,854
|
|
3,000
|
Other long term
liabilities
|
|
|
105
|
|
15
|
Total liabilities
|
|
|
14,626
|
|
8,236
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
Common stock, $0.01 par
value, 60,000,000 shares authorized; 52,577,787 and 46,748,575 shares issued and
outstanding as
of September 30, 2014
and December 31, 2013, respectively
|
|
|
545
|
|
487
|
Additional paid-in
capital
|
|
|
77,563
|
|
51,541
|
Accumulated
deficit
|
|
|
(45,217)
|
|
(44,837)
|
Total stockholders' equity
|
|
|
32,891
|
|
7,191
|
Total liabilities and stockholders' equity
|
|
|
$47,517
|
|
$15,427
|
|
|
|
|
|
|
|
|
|
|
|
|
*Derived from the
audited December 31, 2013 financial statements
|
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SOURCE IGI Laboratories, Inc.