Revenue for Six Months Exceeds $11 Million
FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 10, 2007--Unigene
Laboratories, Inc. (OTCBB: UGNE) reports its financial results for the
three months and six months ended June 30, 2007.
Revenue for the three months ended June 30, 2007 increased to
$4,718,000 compared with $556,000 for the three months ended June 30,
2006. Revenue for the six months ended June 30, 2007 increased to
$11,046,000 compared with $943,000 for the six months ended June 30,
2006. Revenue from Fortical sales and royalties was $3,374,000 and
$7,836,000, respectively, for the three months and six months ended
June 30, 2007.
Fortical royalties were $1,075,000 and $348,000 for the three
months ended June 30, 2007 and 2006, respectively, and $2,920,000 and
$546,000 for the six months ended June 30, 2007 and 2006,
respectively. Fortical sales were $2,300,000 and $4,915,000 for the
three months and six months ended June 30, 2007, respectively. Sales
of peptide to Novartis were $792,000 and $2,200,000 for the three
months and six months ended June 30, 2007, respectively. There were no
product sales during the first half of 2006.
Net loss for the three months ended June 30, 2007 was $1,294,000,
or $0.01 per share, compared with a net loss of $3,002,000, or $0.03
per share, for the three months ended June 30, 2006.
Net loss for the six months ended June 30, 2007 was $1,538,000, or
$0.02 per share, compared with a net loss of $6,244,000, or $0.07 per
share, for the six months ended June 30, 2006.
Operating expenses were $5,758,000 for the three months ended June
30, 2007, compared with $3,300,000 for the three months ended June 30,
2006 and were $11,962,000 for the six months ended June 30, 2007,
compared with $6,543,000 for the six months ended June 30, 2006. The
increases were primarily due to cost of goods sold resulting from the
increased product sales to Upsher-Smith and Novartis. The three months
ended June 30, 2007 and 2006 includes $289,000 and $262,000,
respectively, in expenses for non-cash stock option compensation. The
six months ended June 30, 2007 and 2006 includes $682,000 and
$427,000, respectively, in expenses for non-cash stock option
compensation.
The Company's cash balance at June 30, 2007 was $6,765,000, an
increase of approximately $3,407,000 from December 31, 2006. Accounts
receivable at June 30, 2007 were $2,608,000, an increase of $1,368,000
from December 31, 2006.
Deferred licensing fees increased $4,955,000 from December 31,
2006, primarily due to the $5,500,000 Phase III milestone payment
received from Novartis which was only partially recognized as revenue
in the first half of 2007.
The Company believes that cash on hand, as well as cash generated
from Fortical sales and royalties, will be sufficient to meet our
obligations for the next twelve months. Therefore, disclosure relating
to the uncertainty of the Company's ability to continue as a going
concern is not included in our June 30, 2007 Form 10Q.
Following are highlights for the second quarter of 2007:
- According to IMS, prescriptions for Fortical(R), the Company's
first U.S. product that was launched in August 2005, totaled
263,000 for the quarter, reflecting a 15% increase from the
first quarter and a nasal calcitonin market share of
approximately 47%.
- The Company restructured its loan obligations, recasting $15.7
million in debt as eight-year term loans. The interest rate
associated with these new notes is 9%, and although no
payments are required for the first three years of the notes,
there is also no prepayment penalty. This reduces the
Company's aggregate annual interest payments and eliminates
all notes that had been in default. This restructuring
strengthens the Company's financial position and, in
conjunction with the elimination of the going concern
disclosure in our 10Q, it is an important step in achieving
compliance with the listing requirements of certain stock
exchanges.
"Increasing revenue from Fortical in combination with the
restructured loan obligation has materially strengthened Unigene's
financial position," commented Dr. Warren Levy, President and CEO of
Unigene. "We are implementing a three-pronged strategy utilizing these
resources to strengthen our technology platforms, advance the
development of certain internal programs and broaden the Company's
pipeline."
Recently, the Company announced that it had improved its
Enteripep(R) oral delivery technology, moved its internal oral
calcitonin program into the clinic and announced the in-licensing of
certain products for inflammation and cardiovascular treatment.
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.
UNIGENE LABORATORIES, INC.
CONDENSED BALANCE SHEETS
June 30, December 31,
2007 2006
--------------- ---------------
ASSETS (Unaudited)
--------------------------------------
Current assets:
Cash and cash equivalents $ 6,764,506 $ 3,357,351
Accounts receivable 2,608,459 1,240,114
Inventory 3,712,889 5,283,000
Prepaid expenses and other current
assets 385,972 303,444
------------- --------------
Total current assets 13,471,826 10,183,909
Noncurrent inventory 348,075 --
Property, plant and equipment, net 2,436,513 2,364,141
Investment in joint venture 29,953 30,545
Patents and other intangibles, net 1,656,294 1,438,848
Other assets 129,305 33,879
------------- --------------
Total assets $ 18,071,966 $ 14,051,322
============= ==============
LIABILITIES AND STOCKHOLDERS' DEFICIT
--------------------------------------
Current liabilities:
Accounts payable $ 965,485 $ 884,958
Accrued expenses - other 1,906,132 1,806,707
Current portion - deferred
licensing fees 1,262,756 762,752
Notes payable - stockholders -- 8,105,000
Accrued interest - stockholders -- 8,081,180
Current portion - capital lease
obligations 57,324 70,780
------------- --------------
Total current
liabilities 4,191,697 19,711,377
Notes payable stockholders 15,737,517 --
Deferred licensing fees, excluding
current portion 12,611,212 8,156,262
Capital lease obligations, excluding
current portion 18,226 40,880
Deferred compensation 354,118 330,643
Accrued interest-stockholders 197,905 --
------------- --------------
Total liabilities 33,110,675 28,239,162
------------- --------------
Commitments and contingencies
Stockholders' deficit:
Stockholders' deficit:
Common Stock - par value $.01 per
share, authorized 135,000,000
shares, issued and outstanding:
87,738,515 shares in 2007 and
87,731,015 shares in 2006 877,385 877,310
Additional paid-in capital 105,427,441 104,740,178
Accumulated deficit (121,343,535) (119,805,328)
------------- --------------
Total stockholders'
deficit (15,038,709) (14,187,840)
------------- --------------
Total liabilities and
stockholders deficit $ 18,071,966 $ 14,051,322
============= ==============
UNIGENE LABORATORIES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended Six months ended
June 30, June 30
------------------------- -------------------------
2007 2006 2007 2006
------------ ------------ ------------ ------------
Revenue:
Product sales $ 3,091,677 $ -- $ 7,115,409 $ --
Royalties 1,074,657 347,944 2,920,099 545,646
Licensing
revenue 347,690 189,189 578,546 378,378
Development fees
and other 204,188 18,854 432,430 18,854
------------ ------------ ------------ ------------
4,718,212 555,987 11,046,484 942,878
------------ ------------ ------------ ------------
Operating
expenses:
Cost of goods
sold 1,659,753 -- 3,679,404 --
Research,
development and
facility
expenses 2,178,960 1,860,699 4,303,095 3,403,805
General and
administrative 1,919,088 1,439,708 3,979,323 3,139,585
------------ ------------ ------------ ------------
5,757,801 3,300,407 11,961,822 6,543,390
------------ ------------ ------------ ------------
Operating loss (1,039,589) (2,744,420) (915,338) (5,600,512)
Other income
(expense):
Interest and
other income 117,977 114,012 149,700 141,036
Interest
expense- (372,427) (371,373) (772,569) (784,977)
principally to
stockholders
------------ ------------ ------------ ------------
Loss before income
taxes (1,294,039) (3,001,781) (1,538,207) (6,244,453)
Income tax expense -- -- -- --
------------ ------------ ------------ ------------
Net loss $(1,294,039) $(3,001,781) $(1,538,207) $(6,244,453)
============ ============ ============ ============
Loss per share -
basic and
diluted:
Net loss per
share $ (0.01) $ (0.03) $ (0.02) $ (0.07)
------------ ------------ ------------ ------------
Weighted average
number of shares
outstanding -
basic and
diluted 87,735,922 87,663,388 87,733,661 85,884,031
============ ============ ============ ============
CONTACT: Unigene Investor
The Investor Relations Group
Daniel Berg/Dian Griesel, Ph.D., 212-825-3210
or
Media
Lynn Granito, 212-825-3210
SOURCE: Unigene Laboratories, Inc.
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