ADDISON, Texas, April 2, 2012 /PRNewswire/ -- ULURU Inc.
(OTCQB: ULUR) today announced its financial results for the fourth
quarter and year ended December 31,
2011 and provided a review of its operating activities.
During the past 12 months significant achievements have been
made by ULURU to expand the global commercialization of Altrazeal®,
including:
- Execution of an agreement to market Altrazeal® in Europe;
- Agreement to market Altrazeal® in Australia, New
Zealand, and selected Middle Eastern markets;
- Approval to market Altrazeal® in Australia and New
Zealand;
- Commencement of clinical studies to support the cost
effectiveness of Altrazeal® in treating chronic wounds; and
- Generation of clinical data supporting the use of Altrazeal® in
additional indications including diabetic foot ulcers with
removable off-loading.
In addition, we received a patent specifically covering the
wound care application of our NanoFlex™ technology which extends
the patent life of Altrazeal® until 2027. This patent has also been
granted in numerous international territories and is under review
in other global markets.
In the upcoming six month period our business outlook is for a
significant expansion in commercial activities, including the
following:
- The first shipment of Altrazeal® to our exclusive worldwide
distributor for marketing in the veterinary market;
- The first European order for Altrazeal® has been received and
will be supplied;
- Altrazeal® is planned for launch in 5 markets including
Germany, Australia and New
Zealand;
- Approval for marketing in China is scheduled to be received;
- The first shipment of product to China is planned;
- Launch of the 0.75 gram blister package in the United States, which is designed to expand
product usage, including use in additional hospital accounts and
long term care facilities; and
- Completion of additional strategic alliances.
As a result of the achievements and activities outlined above,
commencing the second quarter, the Company is projecting a
significant increase in product sales in 2012. This increase in
revenue is forecast to escalate during the course of 2012 and 2013
as Altrazeal® is launched in additional European markets and our
partnership network is expanded to include further international
markets.
Commenting on the business activities Kerry P. Gray, President and CEO stated, "The
achievements in the past 12 months have favorably positioned the
Company for significant revenue growth in 2012 and beyond. The
initial response Altrazeal® has received from the medical community
in Europe and Australia is very encouraging. It is
anticipated that the clinical data being generated in these markets
will drive the rapid adoption of Altrazeal®. We are looking forward
to the introduction of Altrazeal® in Germany, Australia and New
Zealand where we believe the product attributes of
Altrazeal®, lower treatment cost and improved clinical outcomes,
will enable Altrazeal® to rapidly gain market share. We plan on
further extending our network of licensing partners during 2012 to
have all major markets, with the possible exception of Japan, covered by year end. Also, we are
excited about the near term introduction of Altrazeal® into the
veterinary market. These activities should further enhance our
revenue growth."
For the fourth quarter of 2011, the Company reported a net loss
of $0.9 million, or $0.13 per share, compared with a net loss of
$0.3 million, or $0.05 per share, for the same period last year.
For the year ending December 31,
2011, the Company reported a net loss of $4.1 million, or $0.67 per share, compared with a net loss of
$5.0 million, or $0.93 per share, in the same period of 2010. As
of January 31, 2012, the Company held
cash and cash equivalents of approximately $215,000.
Revenues
Revenues for the fourth quarter of 2011 were $256,000, compared to $1,029,000 for the fourth quarter of 2010.
The decrease of approximately $773,000 in revenues from the fourth quarter of
2010 compared to the fourth quarter of 2011 was primarily due to
decreased licensing fees as the prior year included the recognition
of $751,000 in unamortized licensing
fees.
For the year ending December 31,
2011, revenues were $485,000,
compared to $1,557,000 for the same
period of 2010. The decrease of approximately $1,072,000 was due primarily to the following
factors; a reduction of $988,000 in
OraDisc™ related licensing fees and a decrease of $186,000 in Zindaclin® related licensing and
royalty fees due to our divestiture of this product in September 2010, this was partially offset by
increased product sales.
Research and Development
Research and development expenses for the fourth quarter of 2011
were $198,000, including $17,000 in share-based compensation, compared to
$309,000, including $32,000 in share-based compensation, for the
fourth quarter of 2010. The decrease of approximately
$111,000 in research and development
expenses was primarily was due primarily to lower costs for direct
research costs of $85,000.
For the year ending December 2011,
research and development expenses were $950,000, including $70,000 in share-based compensation, compared to
$1,260,000, including $136,000 in share-based compensation, for the
same period in 2010. The decrease of approximately $311,000 in research and development expenses was
due primarily to lower costs for regulatory fees of $140,000, direct research costs of $73,000, clinical testing costs for our wound
care technologies of $46,000 and
scientific compensation costs of $30,000.
Selling, general and administrative
Selling, general and administrative expenses for the fourth
quarter of 2011 were $498,000,
including $25,000 in share-based
compensation, compared to $715,000,
including $34,000 in share-based
compensation, for the fourth quarter of 2010. The decrease of
approximately $217,000 in selling,
general and administrative expenses was primarily due to lower
costs for compensation of $21,000,
lower legal costs relating to our patents of $70,000, lower shareholder expenses of
$65,000, relating to investor
relations consulting and decreased sales & marketing costs of
$64,000 due to a revised marketing
plan.
For the year ending December 2011,
selling, general and administrative expenses were $2,280,000, including $102,000 in share-based compensation, compared to
$3,120,000 million, including
$230,000 of share-based compensation,
for the same period in 2010.
The decrease of approximately $843,000 in selling, general and administrative
expenses was primarily due to lower costs for compensation of
$183,000, sales & marketing costs
of $348,000 due to a revised
marketing plan, legal costs relating to our patents of $158,000 and commission expense of $30,000.
Interest Expense
Interest expense for the fourth quarter of 2011 was $19,000 as compared to $14,000 for the fourth quarter of 2010 and is
comprised of financing costs for our insurance policies, interest
costs related to regulatory fees, and interest costs and
amortization of debt discount related to our convertible debt.
For the year ending December 2011,
interest expense was $67,000 as
compared to $51,000 for the same
period of 2010. The increase of approximately $16,000 is primarily attributable to costs
associated with our convertible debt.
Loss on Sale of Intangible Assets
For the year ending December 2011,
there were no intangible asset divestitures. For the year
ending December 2010, loss on sale of
intangible assets was $858,000 and
consisted of the June 2010
divestiture of our Zindaclin® intangible asset.
Mr. Gray continued, "The 2011 operating results reflect a
significant improvement in our reported loss from 2010 and is due
principally to the positive effects of our business restructuring
and tight controls over our operating expenses. With the
projected increase in revenues for 2012, we are forecasting a
significant improvement in operating results particularly in the
second half of the year as our international business is forecast
for rapid growth."
About ULURU Inc.:
ULURU Inc. is a specialty pharmaceutical company focused
on the development of a portfolio of wound management and oral care
products to provide patients and consumers improved clinical
outcomes through controlled delivery utilizing its innovative
Nanoflex® Aggregate technology and OraDisc™ transmucosal delivery
system. For further information about ULURU Inc., please visit our
website at www.uluruinc.com. For further information about
Altrazeal®, please visit our website at www.altrazeal.com.
This press release contains certain statements that are
forward-looking within the meaning of Section 27a of the Securities
Act of 1933, as amended, including but not limited to statements
made relating to future financial performance of ULURU Inc., (the
"Company"). The progress of our technology, clinical and
regulatory results for our products, advantages of our products,
and cost saving initiatives, anticipated product launches and
regulatory filings, near term revenue opportunities and anticipated
extensions of product lines. When used in this press release, the
words "may," "targets," "goal," "could," "should," "would,"
"believe," "feel," "hope," "expects," "confident," "anticipate,"
"estimate," "intend," "plan," "potential" and similar expressions
may be indicative of forward-looking statements. These statements
by their nature involve substantial risks and uncertainties,
certain of which are beyond the Company's control. Any
forward-looking statement speaks only as of the date on which such
statement is made, and the Company undertakes no obligation to
update any forward-looking statement or statements to reflect
events or circumstances after the date on which such statement is
made or to reflect the occurrence of an unanticipated event.
Further, management cannot assess the impact of each such factor on
the business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those
contained in any forward-looking statements. These
statements are subject to numerous risks and uncertainties,
including but not limited to the risk factors detailed in the
Company's Annual Report on Form 10-K for the year ending
December 31, 2011 and other reports
filed by us with the Securities and Exchange Commission.
Contact: Company
Kerry P. Gray
President & CEO
Terry K. Wallberg
Vice President & CFO
(214) 905-5145
ULURU
Inc.
SUMMARY OF
RESULTS
STATEMENTS
OF OPERATIONS DATA
|
|
|
(Unaudited)
|
|
(Audited)
|
|
|
Three Months
Ended December 31,
|
|
Years Ended
December 31,
|
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
REVENUES
|
|
|
|
|
|
|
|
|
|
License fees
|
$
4,494
|
|
$ 949,271
|
|
$
22,843
|
|
$ 1,099,554
|
|
|
Royalty income
|
17,127
|
|
25,991
|
|
68,656
|
|
158,464
|
|
|
Product sales
|
233,905
|
|
53,614
|
|
393,037
|
|
299,339
|
|
|
Total Revenues
|
255,526
|
|
1,028,876
|
|
484,536
|
|
1,557,357
|
|
|
|
|
|
|
|
|
|
|
COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
167,608
|
|
10,211
|
|
203,154
|
|
153,470
|
|
|
Research and
development
|
197,504
|
|
309,100
|
|
946,553
|
|
1,258,060
|
|
|
Selling, general and
administrative
|
497,761
|
|
714,758
|
|
2,276,806
|
|
3,119,881
|
|
|
Amortization of intangible
assets
|
156,500
|
|
206,454
|
|
769,132
|
|
905,706
|
|
|
Depreciation
|
75,359
|
|
77,020
|
|
303,024
|
|
256,073
|
|
|
Total Costs and
Expenses
|
1,094,732
|
|
1,317,543
|
|
4,498,669
|
|
5,693,190
|
|
|
|
|
|
|
|
|
|
|
OPERATING
(LOSS)
|
(839,206)
|
|
(288,667)
|
|
(4,014,133)
|
|
(4,135,833)
|
|
|
|
|
|
|
|
|
|
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
|
|
Interest and miscellaneous
income
|
1,856
|
|
4,375
|
|
11,341
|
|
9,930
|
|
|
Interest
expense
|
(18,461)
|
|
(13,713)
|
|
(67,300)
|
|
(50,851)
|
|
|
Loss on sale of intangible
assets
|
---
|
|
---
|
|
---
|
|
(857,839)
|
|
(LOSS)
Before Income Taxes
|
(855,811)
|
|
(298,005)
|
|
(4,070,092)
|
|
(5,034,593)
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes
|
---
|
|
---
|
|
---
|
|
---
|
|
NET
(LOSS)
|
$(855,811)
|
|
$(298,005)
|
|
$ (4,070,092)
|
|
$ (5,034,593)
|
|
|
|
|
|
|
|
|
|
|
|
Less preferred stock
dividends
|
(3,925)
|
|
---
|
|
(4,387)
|
|
---
|
|
NET (LOSS)
Allocable to Common Stockholders
|
$(859,736)
|
|
$(298,005)
|
|
$ (4,074,479)
|
|
$ (5,034,593)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
(loss) per common share
|
$ (0.13)
|
|
$ (0.05)
|
|
$ (0.67)
|
|
$ (0.93)
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING
|
6,702,759
|
|
5,474,482
|
|
6,065,615
|
|
5,436,033
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ULURU
Inc.
SELECTED CONSOLIDATED BALANCE
SHEET DATA
|
|
|
December 31,
2011
|
|
December 31,
2010
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
46,620
|
|
$
641,441
|
|
Current
assets
|
1,349,456
|
|
1,996,265
|
|
Property and
equipment, net
|
1,072,460
|
|
1,375,484
|
|
Other
assets
|
4,640,504
|
|
5,648,764
|
|
Total
assets
|
7,062,420
|
|
9,020,513
|
|
|
|
|
|
|
Current
liabilities
|
2,053,867
|
|
1,019,597
|
|
Long term
liabilities – convertible note payable
|
234,882
|
|
---
|
|
Long term
liabilities – deferred revenue
|
672,282
|
|
594,653
|
|
Total
liabilities
|
2,961,031
|
|
1,614,250
|
|
Total stockholders'
equity
|
4,101,389
|
|
7,406,263
|
|
|
|
|
|
|
|
SOURCE ULURU Inc.