Record Revenue for 2007 Increases 237% to $20,400,000
FAIRFIELD, N.J.--(BUSINESS WIRE)--March 17, 2008--Unigene
Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) has reported
its financial results for December 31, 2007.
Revenue for the three months ended December 31, 2007 was
$3,033,000, compared to $3,415,000 for the three months ended December
31, 2006, and $20,423,000 for the year ended December 31, 2007,
compared to $6,059,000 for the year ended December 31, 2006. Revenue
for all periods primarily consists of Fortical sales and royalties,
which were $16,131,000 for the year ended December 31, 2007, and
$5,272,000 for the year ended December 31, 2006.
Net loss for the three months ended December 31, 2007 was
$1,670,000, or $.02 per share, compared to a net loss of $3,025,000,
or $.03 per share, for the three months ended December 31, 2006.
Net loss for the year ended December 31, 2007 was $3,448,000, or
$.04 per share, compared to a net loss of $11,784,000, or $.14 per
share, for the year ended December 31, 2006. The years ended December
31, 2007 and December 31, 2006, include $954,000 and $794,000,
respectively, in expenses for non-cash stock option compensation.
Total operating expenses were $5,256,000 for the three months
ended December 31, 2007, a decrease of $1,343,000 from $6,599,000 for
the three months ended December 31, 2006.
Total operating expenses were $23,522,000 for the year ended
December 31, 2007, an increase of $6,483,000 from $17,039,000 for the
year ended December 31, 2006. The increase was primarily attributable
to increased cost of goods sold, due to increased sales to
Upsher-Smith and Novartis.
Cash at December 31, 2007 was $3,678,000, an increase of
approximately $320,000 from December 31, 2006.
Following are some of the highlights of 2007 accomplishments and
new developments that will be discussed during Tuesday's earnings
call:
-- 2007 revenues increased 237% as compared with 2006, to a
record $20.4 million, and the net loss decreased 71% during
the same period.
-- According to IMS, Fortical prescriptions have captured more
than 52% of the US nasal calcitonin market, making Fortical
the most frequently prescribed nasal calcitonin product in the
US.
-- Novartis and its development partner initiated two pivotal
Phase III studies in 2007 for their oral calcitonin program
using our licensed production technology, triggering a $5.5
million payment to Unigene from Novartis. The studies will
evaluate the possible use of oral calcitonin for osteoporosis
and osteoarthritis.
-- Unigene's oral calcitonin program's Phase I/II study was
successfully completed and Unigene intends to take the product
into the pivotal clinical study with a corporate partner.
-- Unigene and SPG plan to expand their Chinese joint venture to
allow for the development of new pharmaceutical products in
China, with Unigene retaining 45% ownership of the joint
venture and any profits/losses that are realized.
-- Unigene's Site-Directed Bone Growth technology was described
in a publication last month in the journal Tissue Engineering.
Results show that normal bone growth occurred at an
accelerated rate at only the targeted location.
-- Unigene intends to conduct a clinical study with its improved
formulation of oral parathyroid hormone. Preparations are
currently underway.
-- Unigene licensed early-stage technologies from the University
of London in 2007 with potential application to the treatment
of inflammatory diseases and cardiac reperfusion injury.
-- Unigene is currently performing a number of externally funded
feasibility studies evaluating the application of its oral
delivery and/or manufacturing technologies to peptides for
various indications that are proprietary to pharmaceutical
companies.
-- During 2007, Unigene had positive cash flow from operations,
with more than $3 million provided from corporate activities.
However, due to increased expenses associated with the above
programs and continuing fluctuation in quarterly revenues,
Unigene will need additional revenues or other sources of
funds, which the company is pursuing.
Unigene will host a conference call tomorrow morning, Tuesday,
March 18th at 9:00 AM EDT, to discuss its 2007 year-end 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 866-585-6398 for participants in the United States and
416-849-9626 for international participants.
UNIGENE LABORATORIES, INC.
BALANCE SHEETS
DECEMBER 31, 2007 and 2006
2007 2006
------------ -------------
ASSETS
Current assets:
Cash and cash equivalents $ 3,677,637 $ 3,357,351
Accounts receivable 3,142,196 1,240,114
Inventory 3,327,289 5,283,000
Prepaid expenses and other current assets 908,168 303,444
------------ -------------
Total current assets 11,055,290 10,183,909
Noncurrent inventory 627,020 --
Property, plant and equipment, net 3,217,608 2,364,141
Patents and other intangibles, net 1,810,987 1,438,848
Investment in joint venture 27,440 30,545
Other assets 135,815 33,879
----------- ------------
Total assets $ 16,874,160 $ 14,051,322
============ =============
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable $ 1,328,272 $ 884,958
Accrued expenses - other 1,983,558 1,806,707
Current portion - deferred licensing fees 1,313,006 762,752
Notes payable - stockholders -- 8,105,000
Accrued interest - stockholders -- 8,081,180
Current portion - capital lease
obligations 40,078 70,780
----------- ------------
Total current liabilities 4,664,914 19,711,377
Notes payable - stockholders 15,737,517 --
Accrued interest - stockholders 783,279 --
Deferred licensing fees, excluding
current portion 11,982,829 8,156,262
Capital lease obligations, excluding
current portion 1,865 40,880
Deferred compensation 374,500 330,643
------------ -------------
Total liabilities 33,544,904 28,239,162
Commitments and contingencies
Stockholders' deficit:
Common Stock - par value $.01 per share,
authorized 135,000,000 shares;
issued and outstanding: 87,753,715 shares
in 2007 and 87,731,015 shares in 2006. 877,537 877,310
Additional paid-in capital 105,705,387 104,740,178
Accumulated deficit (123,253,668) (119,805,328)
------------ -------------
Total stockholders' deficit ( 16,670,744) (14,187,840)
------------ -------------
Total liabilities and stockholders'
deficit $ 16,874,160 $ 14,051,322
============ =============
UNIGENE LABORATORIES, INC.
STATEMENTS OF OPERATIONS
Years Ended December 31, 2007, 2006 and 2005
2007 2006 2005
------------ ------------- ------------
Revenue:
Product sales $12,758,640 $ 2,829,678 $ 6,836,524
Royalties 5,572,349 2,450,531 2,613,364
Licensing revenue 1,173,429 756,759 4,756,753
Development services 300,000 -- 11,729
Grant and other revenue 618,411 21,964 57,180
----------- ------------ -----------
20,422,829 6,058,932 14,275,550
----------- ------------ -----------
Operating expenses:
Cost of goods sold 7,222,534 1,752,680 1,448,472
Research, development and
facility expenses 8,487,687 8,567,452 6,034,343
General and administrative 7,811,966 6,422,693 4,639,638
Inventory reserve -- 296,266 1,558,689
----------- ------------ -----------
23,522,187 17,039,091 13,681,142
----------- ------------ -----------
Operating (loss) income (3,099,358) (10,980,159) 594,408
Other income (expense):
Interest income 305,015 265,489 32,799
Interest expense-principally
to stockholders (1,377,929) (1,598,265) (1,542,711)
----------- ------------ -----------
Loss before income taxes (4,172,272) (12,312,935) (915,504)
Income tax benefit -
principally from sale of New
Jersey tax benefits 723,932 528,799 419,911
----------- ------------ -----------
Net loss $(3,448,340) $(11,784,136) $ (495,593)
=========== ============ ===========
Loss per share - basic and
diluted:
Net loss per share $ (0.04) $ (0.14) $ (0.01)
=========== ============ ===========
Weighted average number of
shares outstanding - basic
and diluted 87,742,329 86,813,378 81,482,223
----------- ------------ -----------
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
August 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) 882-0860 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.
CONTACT: The Investor Relations Group
Investors:
Erika Moran/Dian Griesel, Ph.D., 212-825-3210
or
Media:
Lynn Granito, 212-825-3210
SOURCE: Unigene Laboratories, Inc.
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