FAIRFIELD, N.J.--(BUSINESS WIRE)--Nov. 9, 2006--Unigene
Laboratories, Inc. (OTCBB: UGNE) announced its financial results for
September 30, 2006.
Revenue for the three months ended September 30, 2006 was
$1,701,000 compared to $11,873,000 for the three months ended
September 30, 2005 and $2,644,000 for the nine months ended September
30, 2006 compared to $12,676,000 for the nine months ended September
30, 2005. Revenue from Fortical sales and royalties were $1,510,000
for the three months ended September 30, 2006, $348,000 for the three
months ended June 30, 2006 and $197,000 for the three months ended
March 31, 2006.
Fortical royalties were $673,000 and $2,007,000 respectively, for
the three months ended September 30, 2006 and 2005 and $1,218,000 and
$2,007,000 respectively, for the nine months ended September 30, 2006
and 2005. Fortical sales were $837,000 for the three month and nine
month periods ended September 30, 2006. Sales, primarily Fortical,
were $5,675,000 and $6,033,000, respectively, for the three month and
nine month periods ended September 30, 2005.
Our net loss for the three months ended September 30, 2006 was
$2,515,000, or ($.03) per share, compared to net income of $7,897,000,
or $.09 per share, fully diluted, for the three months ended September
30, 2005. The three months ended September 30, 2006 includes $147,000
in expenses for non-cash stock option compensation under SFAS 123 (R).
Our net loss for the nine months ended September 30, 2006 was
$8,759,000 or ($.10) per share, compared to net income of $2,157,000,
or $.03 per share, fully diluted, for the nine months ended September
30, 2005. The nine months ended September 30, 2006 includes $596,000
in expenses for non-cash stock option compensation under SFAS 123 (R),
as well as $322,000 in non-cash expenses related to our deferred
compensation plan. As of September 30, 2006, we have an additional
$1,248,000 in expenses for non-cash stock option compensation that
remains to be recognized, primarily in 2007.
Total operating expenses were $3,897,000 for the three months
ended September 30, 2006, an increase from $3,562,000 for the three
months ended September 30, 2005.
Total operating expenses were $10,440,000 for the nine months
ended September 30, 2006, an increase from $9,380,000 for the nine
months ended September 30, 2005.
Our cash balance at September 30, 2006 was $4,825,000, an increase
of approximately $679,000 from year-end.
"Retail sales of Fortical, our first U.S. product for the
treatment of osteoporosis, continue to grow at an appreciable rate,"
commented Warren P. Levy, Ph.D., President and CEO. "According to NDC,
a well-recognized pharmaceutical sales tracking service, Fortical
prescriptions have exceeded 60,000 for the month of September,
representing a market share of approximately 28%. In August, we
reported that the process of "pull through" was complete. Our partner,
Upsher-Smith Laboratories, has submitted purchase orders for the
remainder of 2006 and the beginning of 2007. As Upsher-Smith and their
customers have begun to rebuild inventories, a more regular ordering
pattern seems to be developing. As evidence of this, we have reported
that our sales and royalties grew from $348,000 in the second quarter
to $1,510,000 in the third quarter, reflecting significant growth
despite the fact that the first re-order was filled in mid-quarter. We
are encouraged by that increase and believe that the prospects for
further increases are excellent."
"We are aggressively pursuing internal activities to support our
partnership with GlaxoSmithKline in oral PTH. These activities include
additional formulations and in vivo testing. The program is being
undertaken with the full support of GSK and we believe it should
expedite the product's development and entrance into Phase II. It is
believed that the opportunity for an oral PTH will continue to grow,
as the currently marketed injectable PTH product sold by a third party
has been projected to achieve annual sales in 2006 exceeding $600
million."
Dr. Levy also said, "Our current clinical studies in China are
expected to be completed late this year or early next year. Following
the conclusion of those studies and analysis of the data, we intend to
meet with the regulatory agency to determine the prospects for, and
timing of, a marketing approval."
"Finally, our site-directed bone growth program is progressing
well. We have repeated and amplified earlier studies and are filing
patent applications overseas in addition to those already filed in the
U.S. We are focusing on several specific possible applications of the
technology, which involves a combination of drugs and device along
with proprietary methodology, including stabilization of the spine,
treatment of chronic back pain and prevention of hip fractures. We
plan to engage key opinion leaders and clinical experts to assist in
the early-stage clinical development of the technology and to seek a
commercial partner with device expertise to assist in the remaining
activities."
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
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"intends," "plans," "predicts," "believes," "seeks," "estimates,"
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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: Investors:
The Investor Relations Group
Damian McIntosh or Dian Griesel, Ph.D., 212-825-3210
SOURCE: Unigene Laboratories, Inc.
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