View:
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
__________________
FORM
8-K
Current
Report
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
__________________
Date
of
Report (Date of earliest event reported):
November
14, 2006
BIOSANTE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
001-31812
|
58-2301143
|
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification Number)
|
|
111
Barclay Boulevard
Lincolnshire,
Illinois
|
60069
|
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
(847)
478-0500
(Registrant’s
Telephone Number, Including Area Code)
N/A
(Former
Name or Former Address, If Changed Since Last Report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
| £ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
| £ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
| £ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
|
| £ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
|
Section
2 - Financial Information
Item
2.02. Results of Operations and Financial Condition.
On
November 14, 2006, BioSante Pharmaceuticals, Inc. publicly announced its
financial results for the third quarter and nine months ended September 30,
2006. For further information, please refer to the press release attached hereto
as Exhibit 99.1, which is incorporated by reference herein.
The
information contained in this Item 2.02 and Exhibit 99.1 hereto shall
not
be deemed to be “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the
liability of that section, and shall not be incorporated by reference into
any
filings made by BioSante
Pharmaceuticals, Inc. under
the
Securities Act of 1933, as amended, or the Exchange Act, except as may be
expressly set forth by specific reference in such filing.
Section
9 - Financial Statements and Exhibits
Item
9.01. Financial Statements and Exhibits.
(c) Exhibits.
|
Exhibit
No.
|
Description
|
|
99.1
|
Press
Release issued November 14,
2006
|
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
BIOSANTE
PHARMACEUTICALS, INC.
By:
/s/
Phillip B. Donenberg
Phillip
B. Donenberg
Chief
Financial Officer, Treasurer and Secretary
Dated:
November
14, 2006
BIOSANTE
PHARMACEUTICALS, INC.
FORM
8-K
Exhibit
Index
|
Exhibit
No.
|
Description
|
Method
of Filing
|
|
99.1
|
Press
Release issued November 14, 2006
|
Furnished
herewith
|
Exhibit
99.1
BioSante
Pharmaceuticals, Inc.
111
Barclay Boulevard
Lincolnshire,
Illinois 60069
www.biosantepharma.com
FOR
IMMEDIATE RELEASE
Amex:
BPA
BioSante
Pharmaceuticals Reports Third Quarter 2006 Financial
Results
And
Reviews Bio-E-Gel® Marketing Agreement
LINCOLNSHIRE,
Illinois - (November 14, 2006) --- 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 123(R) 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.
For
more information, please contact:
Phillip
Donenberg, BioSante Pharmaceuticals, Inc.; (847) 478-0500;
donenber@biosantepharma.com