Message #24 From:
NewsBot Date: November 9, 2006 01:48:00 PM
UGNE News Unigene Announces Results for the Third Quarter of 2006
FAIRFIELD, N.J.--(BUSINESS WIRE)--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®,
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
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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.
