| BOONTON, N.J., Aug 10, 2009 (BUSINESS WIRE) -- Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com)
has reported its financial results for the quarter ended June 30, 2009.
Revenue for the three months ended June 30, 2009 was $4,297,000,
compared to $4,978,000 for the three months ended June 30, 2008. Revenue
for both periods primarily consisted of Fortical sales and royalties,
which were $3,807,000 for the three months ended June 30, 2009, and
$4,110,000 for the three months ended June 30, 2008. Fortical royalties
were $1,077,000 for the three months ended June 30, 2009, compared to
$1,475,000 for the three months ended June 30, 2008. Fortical sales were
$2,730,000 for the three months ended June 30, 2009, compared to
$2,635,000 for the three months ended June 30, 2008. Fortical sales
fluctuate each quarter based upon USL's ordering schedule. Fortical
royalties fluctuate each quarter based upon the timing, pricing and
volume of USL's shipments to its customers, and Fortical net sales have
declined since the launch of competitive products in December 2008.
Revenue for the six months ended June 30, 2009 was $7,488,000, compared
to $9,292,000 for the six months ended June 30, 2008. Revenue for both
periods primarily consisted of Fortical sales and royalties, which were
$6,443,000 for the six months ended June 30, 2009, and $7,900,000 for
the six months ended June 30, 2008. Fortical royalties were $2,404,000
for the six months ended June 30, 2009, compared to $2,613,000 for the
six months ended June 30, 2008. Fortical sales were $4,039,000 for the
six months ended June 30, 2009, compared to $5,287,000 for the six
months ended June 30, 2008.
Total operating expenses were $6,645,000 for the three months ended June
30, 2009, an increase of $801,000 from $5,844,000 for the three months
ended June 30, 2008.
Total operating expenses were $12,089,000 for the six months ended June
30, 2009, an increase of $384,000 from $11,705,000 for the six months
ended June 30, 2008.
Net loss for the three months ended June 30, 2009 was $3,460,000, or
$.04 per share, compared to a net loss of $1,201,000, or $.01 per share,
for the three months ended June 30, 2008.
Net loss for the six months ended June 30, 2009 was $6,735,000, or $.07
per share, compared to a net loss of $3,055,000, or $.03 per share, for
the six months ended June 30, 2008.
Cash at June 30, 2009 was $4,599,000, a decrease of approximately
$3,985,000 from December 31, 2008. Accounts receivable at June 30, 2009
were $3,310,000.
Following are recent highlights and developments that will be discussed
during Tuesday's earnings call:
-
According to IMS, in April 2009, Fortical(R) had a 53% share
of U.S. nasal calcitonin prescriptions, down from the 58% February
market share. The decrease in market share is attributable to the
early December launch of two products generic to the innovator
product, but not to Fortical. Fortical sales and royalties increased
44% in the second quarter of 2009 as compared with the first quarter
of 2009. We do not yet know the long-term effect on Fortical sales and
royalties of the launch of these competing products. However, certain
providers have substituted these products for Fortical, causing
Fortical sales and royalties to decrease. Despite the availability of
these competing products, their impact on Fortical prescriptions has
been moderate to date and Fortical still remains the most frequently
prescribed nasal calcitonin product in the U.S.
-
For our oral calcitonin product, we are preparing for our upcoming
Phase III trial and are finalizing our efforts to enlist a corporate
partner and plan to transfer financial responsibility for the program
as soon as possible.
-
In May, we reported that our first patent covering our Site-Directed
Bone Growth (SDBG) technology had issued. The technology, jointly
invented in collaboration with Yale School of Medicine, is designed to
facilitate and accelerate bone growth at precisely targeted locations
in the body using a simple surgical procedure that can be performed on
an outpatient basis with minimal invasiveness.
-
In May, we drew down the remaining $5 million in non-convertible notes
from our largest institutional stockholder. We will need additional
sources of cash, from revenue or other sources, to meet our
requirements in the near-term.
Unigene will host a conference call tomorrow morning, Tuesday, August
11th at 9:00 AM EDT, to discuss its second quarter 2009 financial
results and to provide a Company update. The Company invites all those
interested in hearing management's discussion to join the call by
dialing (877) 407-0782 for participants in the United States and (201)
689-8567 for international participants.
UNIGENE LABORATORIES, INC.
CONDENSED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
June 30, 2009
|
|
December 31, 2008
|
|
ASSETS
|
|
(Unaudited)
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
4,598,698
|
|
|
$
|
8,583,226
|
|
|
Accounts receivable
|
|
|
3,310,342
|
|
|
|
4,635,036
|
|
|
Inventory, net
|
|
|
3,168,735
|
|
|
|
3,180,019
|
|
|
Prepaid interest
|
|
|
280,000
|
|
|
|
525,000
|
|
|
Prepaid expenses and other current assets
|
|
|
4,630,095
|
|
|
|
1,994,077
|
|
|
Total current assets
|
|
|
15,987,870
|
|
|
|
18,917,358
|
|
|
|
|
|
|
|
|
Noncurrent inventory
|
|
|
3,224,516
|
|
|
|
1,649,690
|
|
|
Property, plant and equipment, net
|
|
|
3,893,206
|
|
|
|
4,023,434
|
|
|
Patents and other intangibles, net
|
|
|
2,192,113
|
|
|
|
2,064,182
|
|
|
Investment in joint venture
|
|
|
1,813,088
|
|
|
|
1,447,418
|
|
|
Deferred financing costs, net
|
|
|
360,022
|
|
|
|
385,787
|
|
|
Other assets
|
|
|
220,364
|
|
|
|
153,110
|
|
|
Total assets
|
|
$
|
27,691,179
|
|
|
$
|
28,640,979
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,075,818
|
|
|
$
|
708,134
|
|
|
Accrued expenses
|
|
|
2,013,757
|
|
|
|
2,038,902
|
|
|
Current portion - deferred licensing fees
|
|
|
1,250,756
|
|
|
|
1,256,756
|
|
|
Notes payable - Levys
|
|
|
786,876
|
|
|
|
--
|
|
|
Accrued interest
|
|
|
393,058
|
|
|
|
--
|
|
|
Total current liabilities
|
|
|
5,520,265
|
|
|
|
4,003,792
|
|
|
|
|
|
|
|
|
Notes payable - Levys, excluding current portion
|
|
|
14,950,641
|
|
|
|
15,737,517
|
|
|
Note payable-Victory Park-net of discount of $1,746,469
|
|
|
17,790,737
|
|
|
|
13,463,439
|
|
|
in 2009 and $1,536,561 in 2008
|
|
|
|
|
|
Accrued interest - principally to Levys, excluding current
|
|
|
|
|
|
portion
|
|
|
2,559,775
|
|
|
|
2,094,973
|
|
|
Accrued expenses, excluding current portion
|
|
|
277,908
|
|
|
|
370,544
|
|
|
Deferred licensing fees, excluding current portion
|
|
|
10,078,189
|
|
|
|
10,726,069
|
|
|
Deferred compensation
|
|
|
399,378
|
|
|
|
371,146
|
|
|
Due to joint venture partner, net of discount of $100,911 in
|
|
|
986,589
|
|
|
|
845,957
|
|
|
2009 and $129,043 in 2008
|
|
|
|
|
|
Total liabilities
|
|
|
52,563,482
|
|
|
|
47,613,437
|
|
|
Commitments and contingencies
|
|
|
|
|
|
Stockholders' deficit:
|
|
|
|
|
|
Common Stock - par value $.01 per share,
|
|
|
|
|
|
authorized 135,000,000 shares, issued and outstanding:
|
|
|
|
|
|
90,731,763 shares in 2009 and 90,195,520 shares in 2008
|
|
|
907,318
|
|
|
|
901,955
|
|
|
Additional paid-in capital
|
|
|
110,287,892
|
|
|
|
109,457,677
|
|
|
Accumulated deficit
|
|
|
(136,067,513
|
)
|
|
|
(129,332,090
|
)
|
|
Total stockholders' deficit
|
|
|
(24,872,303
|
)
|
|
|
(18,972,458
|
)
|
|
Total liabilities and stockholders' deficit
|
|
$
|
27,691,179
|
|
|
$
|
28,640,979
|
|
|
UNIGENE LABORATORIES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
Three months ended June 30,
|
|
Six months ended June 30,
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Product sales
|
$
|
2,729,701
|
|
|
$
|
2,634,687
|
|
|
$
|
4,039,154
|
|
|
$
|
5,287,141
|
|
|
Royalties
|
|
1,077,518
|
|
|
|
1,474,862
|
|
|
|
2,403,673
|
|
|
|
2,613,225
|
|
|
Licensing revenue
|
|
313,690
|
|
|
|
314,190
|
|
|
|
627,880
|
|
|
|
628,380
|
|
|
Development fees and other
|
|
175,677
|
|
|
|
554,114
|
|
|
|
417,295
|
|
|
|
763,205
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,296,586
|
|
|
|
4,977,853
|
|
|
|
7,488,002
|
|
|
|
9,291,951
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
988,565
|
|
|
|
1,511,732
|
|
|
|
1,466,935
|
|
|
|
3,101,526
|
|
|
Research, development and facility expenses
|
|
3,012,257
|
|
|
|
2,362,646
|
|
|
|
5,698,974
|
|
|
|
4,487,501
|
|
|
General and administrative
|
|
2,643,877
|
|
|
|
1,969,681
|
|
|
|
4,922,822
|
|
|
|
4,115,774
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,644,699
|
|
|
|
5,844,059
|
|
|
|
12,088,731
|
|
|
|
11,704,801
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
(2,348,113
|
)
|
|
|
(866,206
|
)
|
|
|
(4,600,729
|
)
|
|
|
(2,412,850
|
)
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
34,621
|
|
|
|
22,071
|
|
|
|
76,347
|
|
|
|
41,352
|
|
|
Interest expense
|
|
(1,161,808
|
)
|
|
|
(355,552
|
)
|
|
|
(2,227,106
|
)
|
|
|
(680,364
|
)
|
|
Loss from investment in joint venture
|
|
(50,991
|
)
|
|
|
(1,552
|
)
|
|
|
(116,286
|
)
|
|
|
(2,643
|
)
|
|
Gain on technology transfer to joint venture
|
|
66,176
|
|
|
|
--
|
|
|
|
132,351
|
|
|
|
--
|
|
|
Loss before income taxes
|
|
(3,460,115
|
)
|
|
|
(1,201,239
|
)
|
|
|
(6,735,423
|
)
|
|
|
(3,054,505
|
)
|
|
Income tax expense
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
Net loss
|
$
|
(3,460,115
|
)
|
|
$
|
(1,201,239
|
)
|
|
|
(6,735,423
|
)
|
|
$
|
(3,054,505
|
)
|
|
|
|
|
|
|
|
|
|
|
Loss per share - basic and diluted:
|
|
|
|
|
|
|
|
|
Net loss per share
|
$
|
(0.04
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.03
|
)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding -
|
|
|
|
|
|
|
|
|
basic and diluted
|
|
90,358,544
|
|
|
|
88,370,858
|
|
|
|
90,220,074
|
|
|
|
88,062,286
|
|
About Unigene
Unigene Laboratories, Inc. is a biopharmaceutical company
focusing on the oral and nasal delivery of large-market peptide drugs.
Due to the size of the worldwide osteoporosis market, Unigene is
targeting its initial efforts on developing calcitonin and PTH-based
therapies. Fortical(R), Unigene's nasal calcitonin product for
the treatment of postmenopausal osteoporosis, received FDA approval and
was launched in 2005. Unigene has licensed the U.S. rights for Fortical
to Upsher-Smith Laboratories, worldwide rights for its oral PTH
technology to GlaxoSmithKline and worldwide rights for its calcitonin
manufacturing technology to Novartis. Unigene's patented oral delivery
technology has successfully delivered, in preclinical and/or clinical
trials, various peptides including calcitonin, PTH and insulin.
Unigene's patented manufacturing technology is designed to
cost-effectively produce peptides in quantities sufficient to support
their worldwide commercialization as oral or nasal therapeutics. For
more information about Unigene, call (973) 265-1100 or visit www.unigene.com.
For information about Fortical, visit www.fortical.com.
Safe Harbor statements under the Private Securities Litigation Reform
Act of 1995: This press release contains forward-looking statements
regarding us and our business, financial condition, results of
operations and prospects. Such forward-looking statements include
those which express plans, anticipation, intent, contingency, goals,
targets or future development and/or otherwise are not statements of
historical fact. We have based these forward-looking statements
on our current expectations and projections about future events and they
are subject to risks and uncertainties known and unknown which could
cause actual results and developments to differ materially from those
expressed or implied in such statements. These forward-looking
statements include statements about the following: general
economic and business conditions, our financial condition, competition,
our dependence on other companies to commercialize, manufacture and sell
products using our technologies, the ability of our products to gain
market acceptance and increase market share, the uncertainty of results
of animal and human testing, the risk of product liability and liability
for human trials, our dependence on patents and other proprietary
rights, dependence on key management officials, the availability and
cost of capital, the availability of qualified personnel, changes in, or
the failure to comply with, governmental regulations, the failure to
obtain regulatory approvals for our products and other risk factors
discussed in our Securities and Exchange Commission filings. Words such
as "anticipates," "expects," "intends," "plans," "predicts," "believes,"
"seeks," "estimates," "may," "will," "should," "would," "potential,"
"continue," and variations of these words (or negatives of these words)
or similar expressions, are intended to identify forward-looking
statements. In addition, any statements that refer to expectations,
projections, or other characterizations of future events or
circumstances, including any underlying assumptions, are forward-looking
statements. These forward-looking statements are not guarantees of
future performance and are subject to certain risks, uncertainties, and
assumptions that are difficult to predict. Therefore, our actual results
could differ materially and adversely from those expressed in any
forward-looking statements as a result of various risk factors.
SOURCE: Unigene Laboratories, Inc.
The Investor Relations Group
Investor:
Erika Moran/Dian Griesel, Ph.D., 212-825-3210
or
Media: Janet Vasquez, 212-825-3210
|
