BOONTON, N.J.--(BUSINESS WIRE)--Nov. 10, 2008--Unigene
Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) has reported
its financial results for the quarter ended September 30, 2008.
Revenue for the three months ended September 30, 2008 was
$5,084,000, compared to $6,343,000 for the three months ended
September 30, 2007. Revenue for both periods primarily consisted of
Fortical sales and royalties, which were $4,277,000 for the three
months ended September 30, 2008, and $5,771,000 for the three months
ended September 30, 2007.
Revenue for the nine months ended September 30, 2008 was
$14,376,000, compared to $17,390,000 for the nine months ended
September 30, 2007. Revenue for both periods primarily consisted of
Fortical sales and royalties, which were $12,178,000 for the nine
months ended September 30, 2008, and $13,607,000 for the nine months
ended September 30, 2007. The nine months ended September 30, 2007
included Fortical royalties for the ten-month period of December 2006
through September 2007 and also included $2,500,000 in revenue from
Novartis under a 2007 supply agreement, consisting of $2,200,000 in
product sales and $300,000 in development service fees.
Total operating expenses were $5,418,000 for the three months
ended September 30, 2008, a decrease of $886,000 from $6,304,000 for
the three months ended September 30, 2007.
Total operating expenses were $17,125,000 for the nine months
ended September 30, 2008, a decrease of $1,141,000 from $18,266,000
for the nine months ended September 30, 2007.
Net loss for the three months ended September 30, 2008 was
$687,000, or $.01 per share, compared to a net loss of $240,000, or
$.00 per share, for the three months ended September 30, 2007.
Net loss for the nine months ended September 30, 2008 was
$3,741,000, or $.04 per share, compared to a net loss of $1,778,000,
or $.02 per share, for the nine months ended September 30, 2007.
Cash at September 30, 2008 was $14,705,000, an increase of
approximately $11,027,000 from December 31, 2007. Accounts receivable
at September 30, 2008 were $2,459,000.
Following are recent highlights of, and developments during, the
third quarter ended September 30, 2008:
-- Sales and royalties from Fortical(R), which continue to
represent the largest component of Unigene's revenue, were
nearly $4.3 million in the third quarter of this year, an
increase of approximately 4% compared to total Fortical
revenues for the second quarter of 2008. Fortical royalty
revenue increased by nearly 11% in the third quarter of 2008
compared to the second quarter of this year.
-- The company's net loss for the third quarter was $687,000, a
decrease of 43% from the second quarter of 2008.
-- Unigene's cash at September 30, 2008 was $14.7 million, an
increase of nearly $13 million compared to the end of the
prior quarter. The company's cash position was enhanced by its
borrowing of $15 million pursuant to a $20 million financing
agreement with Victory Park Capital, a current investor in
Unigene. In connection with this borrowing, Unigene issued to
Victory Park a three-year senior secured non-convertible note
and 1,125,000 shares of common stock that are subject to
lock-up for one year.
-- According to IMS, by September 2008, Fortical had captured
more than 59% of the U.S. nasal calcitonin market, further
solidifying its position as the most frequently prescribed
nasal calcitonin product in the U.S.
-- Unigene is also developing its own oral calcitonin product for
osteoporosis based upon its improved Enteripep(R) technology.
In September the company reported on the results of its
end-of-Phase II meeting with the FDA that established the key
elements of the planned Phase III pivotal study. Unigene has
recently received a favorable response from the FDA to our
request for a Special Protocol Assessment, which confirmed the
FDA's position regarding the final study design parameters,
including patient numbers, eligibility criteria, efficacy
endpoints and methods for statistical analysis. We are
currently preparing a response to the FDA to finalize the
process.
-- Novartis' development partner has completed recruiting for two
ongoing Phase III studies for osteoporosis and osteoarthritis
involving 6,500 patients with an oral formulation using
calcitonin made by Unigene's manufacturing process which
Novartis has licensed from us. A third Phase III study was
recently initiated by Novartis' development partner for knee
osteoarthritis.
-- Last month Unigene initiated a Phase I study with its
optimized oral formulation of parathyroid hormone. The study
is ongoing and should be completed and the data analyzed
around year-end.
Unigene will host a conference call tomorrow morning, Tuesday,
November 11, 2008 at 9:00 AM EDT, to discuss its third 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 877-407-0782 for participants in the United States and
201-689-8567 for international participants. A replay will be
available for seven days after the call and can be accessed by dialing
877-660-6853 for participants in the United States and 201-612-7415
for international participants. When prompted, enter account #286 and
conference ID #301594. The conference call may also be accessed via
the Web at www.unigene.com and a link will be provided for listeners
to join the call.
UNIGENE LABORATORIES, INC.
CONDENSED BALANCE SHEETS
September 30, 2008 December 31, 2007
------------------ -----------------
ASSETS (Unaudited)
---------------------------------
Current assets:
Cash and cash equivalents $ 14,704,842 $ 3,677,637
Accounts receivable 2,459,227 3,142,196
Inventory 3,799,491 3,327,289
Prepaid interest 1,050,000 --
Prepaid expenses and other
current assets 814,864 908,168
------------------ -----------------
Total current assets 22,828,424 11,055,290
Noncurrent inventory 664,666 627,020
Property, plant and equipment,
net 4,116,860 3,217,608
Patents and other intangibles,
net 2,167,737 1,810,987
Investment in joint venture 1,421,462 27,440
Deferred financing costs 364,000 --
Other assets 170,249 135,815
------------------ -----------------
Total assets $ 31,733,398 $ 16,874,160
================== =================
LIABILITIES AND STOCKHOLDERS'
DEFICIT
---------------------------------
Current liabilities:
Accounts payable $ 1,627,617 $ 1,328,272
Accrued expenses 2,509,997 1,983,558
Current portion - deferred
licensing fees 1,288,006 1,313,006
Current portion - capital lease
obligations 5,126 40,078
------------------ -----------------
Total current liabilities 5,430,746 4,664,914
Notes payable - stockholders 15,737,517 15,737,517
Note payable - Victory Park - net
of discount of $1,676,250 13,323,750 --
Accrued interest - principally to
stockholders 1,760,501 783,279
Deferred licensing fees,
excluding current portion 11,040,262 11,982,829
Capital lease obligations,
excluding current portion -- 1,865
Deferred compensation 382,031 374,500
Due to joint venture, net of
discount of $160,064 814,936 --
------------------ -----------------
Total liabilities 48,489,743 33,544,904
------------------ -----------------
Commitments and contingencies
Stockholders' deficit:
Common Stock - par value $.01
per share, authorized
135,000,000 shares, issued and
outstanding: 90,150,520 shares
in 2008 and 87,753,715 shares
in 2007 901,505 877,537
Additional paid-in capital 109,336,838 105,705,387
Accumulated deficit (126,994,688) (123,253,668)
------------------ -----------------
Total stockholders' deficit (16,756,345) (16,670,744)
------------------ -----------------
Total liabilities and
stockholders' deficit $ 31,733,398 $ 16,874,160
================== =================
UNIGENE LABORATORIES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended Nine months ended
September 30, September 30,
------------------------- -------------------------
2008 2007 2008 2007
------------ ------------ ------------ ------------
Revenue:
Product sales $ 2,644,567 $ 4,142,635 $ 7,931,708 $11,258,044
Royalties 1,632,737 1,628,476 4,245,962 4,548,575
Licensing
revenue 314,187 280,691 942,567 859,237
Development fees
and other 492,329 291,668 1,255,534 724,098
------------ ------------ ------------ ------------
5,083,820 6,343,470 14,375,771 17,389,954
------------ ------------ ------------ ------------
Operating
expenses:
Cost of goods
sold 1,455,684 2,685,720 4,557,210 6,365,124
Research,
development and
facility
expenses 2,170,671 1,911,673 6,660,815 6,214,768
General and
administrative 1,791,593 1,706,563 5,907,367 5,685,886
------------ ------------ ------------ ------------
5,417,948 6,303,956 17,125,392 18,265,778
------------ ------------ ------------ ------------
Operating (loss)
income (334,128) 39,514 (2,749,621) (875,824)
Other income
(expense):
Interest and
other (expense)
income (4,465) 91,214 36,887 240,914
Interest
expense-
principally to
stockholders (347,922) (285,656) (1,028,286) (1,058,225)
------------ ------------ ------------ ------------
Loss before income
taxes (686,515) (154,928) (3,741,020) (1,693,135)
Income tax expense -- (85,000) -- (85,000)
------------ ------------ ------------ ------------
Net loss $ (686,515) $ (239,928) $(3,741,020) $(1,778,135)
============ ============ ============ ============
Loss per share -
basic and
diluted:
Net loss per
share $ (0.01) $ (0.00) $ (0.04) $ (0.02)
------------ ------------ ------------ ------------
Weighted average
number of shares
outstanding -
basic and diluted 88,854,264 87,749,919 88,328,206 87,739,140
============ ============ ============ ============
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) 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.
CONTACT: The Investor Relations Group
Investors:
Erika Moran / Dian Griesel, Ph.D., 212-825-3210
or
Media:
Janet Vazquez, 212-825-3210
SOURCE: Unigene Laboratories, Inc.
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