BioSante Pharmaceuticals Reports Third Quarter 2006 Financial Results And Reviews Bio-E-Gel(R) Marketing Agreement
14 Novembre 2006 - 2:00PM
Business Wire
BioSante Pharmaceuticals (AMEX: BPA) today reported its September
30, 2006 cash balance and its financial results for the third
quarter and nine months ended September 30, 2006. In addition,
BioSante reviewed its recently signed marketing agreement with
Bradley Pharmaceuticals, Inc. (NYSE: BDY). The Company�s cash, cash
equivalents and short-term investments as of September 30, 2006
were approximately $10.3 million, as compared to approximately $9.1
million on December 31, 2005. The Company�s cash burn rate for the
first three quarters of 2006 was approximately $650,000 per month.
This burn rate is expected to continue through year-end. BioSante
incurred a net loss of approximately $0.7 million or ($0.03) per
share for the quarter ended September 30, 2006, compared to a net
loss of $1.9 million or ($0.10) per share for the same period in
2005. This decrease was due primarily to a reduction in research
and development expenses, an increase in licensing and grant
revenue, and a reimbursement from BioSante�s insurance company for
previous legal matters. For the nine months ended September, 30,
2006, BioSante incurred a net loss of approximately $6.2 million or
($0.30) per share, compared to a net loss of $7.2 million or
($0.37) per share for the same period in 2005. This decrease was
due primarily to a reduction in research and development expenses,
and an increase in licensing and grant revenue, partially offset by
an increase in non-cash stock-based compensation expense resulting
from the Company�s adoption of SFAS 123R in January 2006. As
previously announced, the Company in November bolstered its cash
position and realized another milestone in the commercialization of
Bio-E-Gel�(transdermal estradiol gel) by signing an exclusive
agreement with Bradley Pharmaceuticals, Inc. for the marketing of
Bio-E-Gel in the United States. Upon execution of the agreement,
BioSante received $2.625 million. Additional regulatory and sales
based milestone payments could bring the total of such payments
from Bradley to BioSante to more than $40 million. The first of
such payments in the amount of $7.0 million to $7.5 million is
triggered by Food and Drug Administration approval (FDA) of
Bio-E-Gel. In addition, Bradley has agreed to pay to BioSante
royalties on sales of Bio-E-Gel, if and when Bio-E-Gel is approved
by the FDA and marketed by Bradley. About BioSante Pharmaceuticals,
Inc. BioSante is developing a pipeline of hormone therapy products
to treat both men and women. These hormone therapy products are gel
formulations for transdermal administration that deliver
bioidentical estradiol and testosterone. BioSante's lead products
include Bio-E-Gel� (transdermal estradiol gel) for the treatment of
women with menopausal symptoms, and LibiGel� (transdermal
testosterone gel) for the treatment of female sexual dysfunction
(FSD). A Bio-E-Gel new drug application (NDA) was submitted to the
FDA in the first quarter 2006. The current market in the U.S. for
estrogen and testosterone products is approximately $2.5 billion.
The transdermal gel formulations used in the women's gel products
are licensed by BioSante from Antares Pharma Inc. The company also
is developing its calcium phosphate nanotechnology (CaP) for novel
vaccines, including avian flu and biodefense vaccines for toxins
such as anthrax and ricin, and drug delivery systems. Additional
information is available online at: www.biosantepharma.com This
news release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. The
statements regarding BioSante contained in this news release that
are not historical in nature, particularly those that utilize
terminology such as "may," "will," "should," "likely," "expects,"
"anticipates," "estimates," "believes", "plans, "hopes", or
comparable terminology, are forward-looking statements.
Forward-looking statements are based on current expectations and
assumptions, and entail various risks and uncertainties that could
cause actual results to differ materially from those expressed in
such forward-looking statements. Important factors known to
BioSante that cause actual results to differ materially from those
expressed in such forward-looking statements are the difficulty of
developing pharmaceutical products, obtaining regulatory and other
approvals and achieving market acceptance, and other factors
identified and discussed from time to time in BioSante's filings
with the Securities and Exchange Commission, including those
factors discussed in BioSante's most recent Forms 10-K and 10-Q,
which discussion also is incorporated herein by reference.
Additional risk factors include the risk that Bio-E-Gel may not be
approved by the FDA or that Bio-E-Gel may not be successfully
marketed. All forward-looking statements speak only as of the date
of this news release. BioSante undertakes no obligation to update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise. BioSante Pharmaceuticals
(AMEX: BPA) today reported its September 30, 2006 cash balance and
its financial results for the third quarter and nine months ended
September 30, 2006. In addition, BioSante reviewed its recently
signed marketing agreement with Bradley Pharmaceuticals, Inc.
(NYSE: BDY). The Company's cash, cash equivalents and short-term
investments as of September 30, 2006 were approximately $10.3
million, as compared to approximately $9.1 million on December 31,
2005. The Company's cash burn rate for the first three quarters of
2006 was approximately $650,000 per month. This burn rate is
expected to continue through year-end. BioSante incurred a net loss
of approximately $0.7 million or ($0.03) per share for the quarter
ended September 30, 2006, compared to a net loss of $1.9 million or
($0.10) per share for the same period in 2005. This decrease was
due primarily to a reduction in research and development expenses,
an increase in licensing and grant revenue, and a reimbursement
from BioSante's insurance company for previous legal matters. For
the nine months ended September, 30, 2006, BioSante incurred a net
loss of approximately $6.2 million or ($0.30) per share, compared
to a net loss of $7.2 million or ($0.37) per share for the same
period in 2005. This decrease was due primarily to a reduction in
research and development expenses, and an increase in licensing and
grant revenue, partially offset by an increase in non-cash
stock-based compensation expense resulting from the Company's
adoption of SFAS 123R in January 2006. As previously announced, the
Company in November bolstered its cash position and realized
another milestone in the commercialization of
Bio-E-Gel(R)(transdermal estradiol gel) by signing an exclusive
agreement with Bradley Pharmaceuticals, Inc. for the marketing of
Bio-E-Gel in the United States. Upon execution of the agreement,
BioSante received $2.625 million. Additional regulatory and sales
based milestone payments could bring the total of such payments
from Bradley to BioSante to more than $40 million. The first of
such payments in the amount of $7.0 million to $7.5 million is
triggered by Food and Drug Administration approval (FDA) of
Bio-E-Gel. In addition, Bradley has agreed to pay to BioSante
royalties on sales of Bio-E-Gel, if and when Bio-E-Gel is approved
by the FDA and marketed by Bradley. About BioSante Pharmaceuticals,
Inc. BioSante is developing a pipeline of hormone therapy products
to treat both men and women. These hormone therapy products are gel
formulations for transdermal administration that deliver
bioidentical estradiol and testosterone. BioSante's lead products
include Bio-E-Gel(R) (transdermal estradiol gel) for the treatment
of women with menopausal symptoms, and LibiGel(R) (transdermal
testosterone gel) for the treatment of female sexual dysfunction
(FSD). A Bio-E-Gel new drug application (NDA) was submitted to the
FDA in the first quarter 2006. The current market in the U.S. for
estrogen and testosterone products is approximately $2.5 billion.
The transdermal gel formulations used in the women's gel products
are licensed by BioSante from Antares Pharma Inc. The company also
is developing its calcium phosphate nanotechnology (CaP) for novel
vaccines, including avian flu and biodefense vaccines for toxins
such as anthrax and ricin, and drug delivery systems. Additional
information is available online at: www.biosantepharma.com This
news release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. The
statements regarding BioSante contained in this news release that
are not historical in nature, particularly those that utilize
terminology such as "may," "will," "should," "likely," "expects,"
"anticipates," "estimates," "believes", "plans, "hopes", or
comparable terminology, are forward-looking statements.
Forward-looking statements are based on current expectations and
assumptions, and entail various risks and uncertainties that could
cause actual results to differ materially from those expressed in
such forward-looking statements. Important factors known to
BioSante that cause actual results to differ materially from those
expressed in such forward-looking statements are the difficulty of
developing pharmaceutical products, obtaining regulatory and other
approvals and achieving market acceptance, and other factors
identified and discussed from time to time in BioSante's filings
with the Securities and Exchange Commission, including those
factors discussed in BioSante's most recent Forms 10-K and 10-Q,
which discussion also is incorporated herein by reference.
Additional risk factors include the risk that Bio-E-Gel may not be
approved by the FDA or that Bio-E-Gel may not be successfully
marketed. All forward-looking statements speak only as of the date
of this news release. BioSante undertakes no obligation to update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
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