BioSante Pharmaceuticals Reports First Quarter 2007 Financial Results
May 01 2007 - 5:00PM
Business Wire
BioSante Pharmaceuticals, Inc. (AMEX:BPA) today reported its March
31, 2007 cash balance and its financial results for the first
quarter ended March 31, 2007. The Company�s cash, cash equivalents
and short-term investments as of March 31, 2007 were approximately
$15.1 million, as compared to approximately $11.5 million on
December 31, 2006. The Company�s cash burn rate in the second
quarter of 2007 is expected to be approximately $750,000 per month.
BioSante incurred a net loss of approximately $1.8 million or
($0.08) per share for the quarter ended March 31, 2007, compared to
a net loss of $3.2 million or ($0.17) per share for the same period
in 2006. This decrease was due primarily to a reduction in business
development costs and legal expenses and a decrease in non-cash
stock-based compensation expense. Recent Product Developments and
Corporate Highlights As previously announced, the Company�in
December 2006 received its first U.S. Food and Drug Administration
(FDA) approval for Elestrin� (estradiol gel) in the treatment of
hot flashes. The lower of the two Elestrin doses approved is the
lowest dose of estradiol approved for the treatment of hot flashes.
In November 2006, the Company bolstered its cash position and
realized another milestone in the commercialization of Elestrin by
signing an exclusive agreement with Bradley Pharmaceuticals, Inc.
(NYSE:BDY) for the marketing of Elestrin in the United States. Upon
execution of the agreement, BioSante received $3.5 million. The
December FDA approval triggered a payment of $10.5 million to
BioSante. In March 2007, the Company received $7.0 million of this
payment and the rest is to be received by year-end 2007.
Sales-based milestone payments could bring payments from Bradley to
BioSante up to an additional $40 million over several years. In
addition, Bradley has agreed to pay to BioSante royalties on sales
of Elestrin. Bradley is planning a mid-2007 launch of the product.
In December 2006, the Company announced that it initiated a Phase
III safety and efficacy trial of LibiGel� (transdermal testosterone
gel) in the treatment of female sexual dysfunction (FSD). The
double-blind, placebo-controlled Phase III trial will enroll
surgically menopausal women for a six-month clinical trial,
conducted under a Phase III protocol reviewed by and on file with
the FDA. In February 2007, the Company announced that a new patent
was issued covering the formulations used in Elestrin (estradiol
gel), BioSante�s newly approved treatment for moderate to severe
vasomotor symptoms associated with menopause and LibiGel�
(transdermal testosterone gel), which recently moved into Phase III
clinical development for the treatment of female sexual
dysfunction. The patent, which was issued on April 3, 2007 covering
both Elestrin and LibiGel, will expire on June 25, 2022. 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 bio-identical estradiol and
testosterone. BioSante's lead products include Elestrin� (estradiol
gel), developed through FDA approval by BioSante, indicated for the
treatment of moderate-to-severe vasomotor symptoms associated with
menopause, and LibiGel� (transdermal testosterone gel) in Phase III
development for the treatment of female sexual dysfunction (FSD).
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, which receives a portion of milestone
payments and royalties on such products. The company also is
developing its calcium phosphate nanotechnology (CaP) for novel
vaccines, including hepatitis B, avian flu and biodefense vaccines
for toxins such as anthrax, as well as a system for delivering
drugs via alternative routes of administration. 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, the success of clinical
testing, 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. 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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