FAIRFIELD, N.J.--(BUSINESS WIRE)--May 12, 2008--Unigene
Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) has reported
its financial results for the quarter ended March 31, 2008.
Revenue for the three months ended March 31, 2008 was $4,314,000,
compared to $6,328,000 for the three months ended March 31, 2007.
Revenue for both periods primarily consisted of Fortical sales and
royalties, which were $3,791,000 for the three months ended March 31,
2008, and $4,461,000 for the three months ended March 31, 2007. The
three months ended March 31, 2007 included Fortical royalties for the
four month period of December 2006 through March 2007 and also
included $1,600,000 in revenue from Novartis under a 2007 supply
agreement.
Net loss for the three months ended March 31, 2008 was $1,853,000,
or $.02 per share, compared to a net loss of $244,000, or $.00 per
share, for the three months ended March 31, 2007.
Total operating expenses were $5,862,000 for the three months
ended March 31, 2008, a decrease of $342,000 from $6,204,000 for the
three months ended March 31, 2007.
Cash at March 31, 2008 was $963,000, a decrease of approximately
$2,715,000 from December 31, 2007. Accounts receivable at March 31,
2008 were $3,543,000.
Following are recent highlights and developments that will be
discussed during Tuesday's earnings call:
- Revenues for the three months ended March 31, 2008 increased
42% compared to revenues for the three month period ended
December 31, 2007 due to an increase in Fortical sales.
Quarterly Fortical sales and royalties will continue to
fluctuate due to the ordering patterns of Upsher-Smith and
their supply contracts with third parties.
- In April 2008, Unigene and its partner expanded the scope of
their Chinese joint venture and broke ground for a global
biotechnology park. The joint venture, called Unigene
Biotechnology Co. Ltd., will initially focus on calcitonin and
parathyroid hormone (PTH) products for the Chinese market as
well as global peptide manufacturing. The joint venture will
also perform research, development, formulation and
manufacturing.
- A subsidiary of our Chinese joint venture partner has entered
into an agreement to purchase 1,080,000 shares of Unigene
common stock at $1.86 per share, representing an 11% premium
to the closing price on April 28, 2008, the date on which the
parties agreed to the purchase price, in anticipation of
finalizing the transaction documents. The total investment
will be approximately $2 million.
- According to IMS, as of March 31, 2008, Fortical prescriptions
have captured more than 55% of the U.S. nasal calcitonin
market, making Fortical the most frequently prescribed nasal
calcitonin product in the U.S.
- The U.S. FDA approved two improvements for the manufacture of
calcitonin, the active ingredient in Fortical(R). The
combination of these improvements is expected to triple batch
yields.
- Unigene successfully completed a Phase I/II study for its oral
calcitonin program. Unigene will meet with the FDA shortly to
confirm the design of the pivotal Phase III clinical study
which Unigene intends to take forward with a corporate
partner.
- Preparations are being finalized for a clinical study
utilizing our improved oral formulation of PTH.
- In April 2008 it was reported that use of an oral
bisphosphonate product for osteoporosis has been associated
with an 86% increase in risk for atrial fibrillation, a known
risk factor for stroke.
Unigene will host a conference call tomorrow morning, Tuesday, May
13th at 9:00 AM EDT, to discuss its first quarter 2008 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. A replay will be
available for seven days after the call and can be accessed by dialing
866-245-6755 for participants in the United States and 416-915-1035
for international participants. When prompted, enter passcode #343608.
The conference call may also be accessed via the Web at
www.unigene.com; a link will be provided for listeners to join the
call.
UNIGENE LABORATORIES, INC.
CONDENSED BALANCE SHEETS
March 31, 2008 December 31, 2007
----------------- -----------------
ASSETS (Unaudited)
----------------------------------
Current assets:
Cash and cash equivalents $ 962,937 $ 3,677,637
Accounts receivable 3,542,987 3,142,196
Inventory 3,528,691 3,327,289
Prepaid expenses and other
current assets 569,531 908,168
----------------- -----------------
Total current assets 8,604,146 11,055,290
Noncurrent inventory 724,822 627,020
Property, plant and equipment, net 4,270,320 3,217,608
Patents and other intangibles, net 1,858,528 1,810,987
Investment in joint venture 26,349 27,440
Other assets 177,739 135,815
----------------- -----------------
Total assets $ 15,661,904 $ 16,874,160
================= =================
LIABILITIES AND STOCKHOLDERS'
DEFICIT
----------------------------------
Current liabilities:
Accounts payable $ 1,895,961 $ 1,328,272
Accrued expenses - other 1,955,971 1,983,558
Current portion - deferred
licensing fees 1,281,756 1,313,006
Current portion - capital lease
obligations 30,374 40,078
----------------- -----------------
Total current liabilities 5,164,062 4,664,914
Notes payable - stockholders 15,737,517 15,737,517
Accrued interest - stockholders 1,099,270 783,279
Deferred licensing fees, excluding
current portion 11,668,639 11,982,829
Capital lease obligations,
excluding current portion -- 1,865
Deferred compensation 377,013 374,500
----------------- -----------------
Total liabilities 34,046,501 33,544,904
----------------- -----------------
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 2008 and 2007 877,537 877,537
Additional paid-in capital 105,844,800 105,705,387
Accumulated deficit (125,106,934) (123,253,668)
----------------- -----------------
Total stockholders' deficit (18,384,597) (16,670,744)
----------------- -----------------
Total liabilities and
stockholders' deficit $ 15,661,904 $ 16,874,160
================= =================
UNIGENE LABORATORIES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended March 31,
-----------------------------
2008 2007
-------------- --------------
Revenue:
Product sales $ 2,652,454 $ 4,023,732
Royalties 1,138,363 1,845,442
Licensing revenue 314,190 230,856
Development fees and other 209,091 228,242
-------------- --------------
4,314,098 6,328,272
-------------- --------------
Operating expenses:
Research, development and facility
expenses 2,125,946 2,124,135
Cost of goods sold 1,589,794 2,019,651
General and administrative 2,146,093 2,060,235
-------------- --------------
5,861,833 6,204,021
-------------- --------------
Operating (loss) income (1,547,735) 124,251
Other income (expense):
Interest income 19,281 31,723
Interest expense-principally to
stockholders (324,812) (400,142)
-------------- --------------
Loss before income taxes (1,853,266) (244,168)
Income tax expense -- --
-------------- --------------
Net loss $ (1,853,266) $ (244,168)
============== ==============
Loss per share - basic and diluted:
Net loss per share $ (0.02) $ (0.00)
============== ==============
Weighted average number of shares
outstanding -
basic and diluted 87,753,715 87,731,376
============== ==============
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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