Message #28 From:
NewsBot Date: December 29, 2007 08:11:44 AM
End of Year Reported at Accentia Biopharmaceuticals
Accentia Biopharmaceuticals Reports Fiscal
2007 Year-End Results; Pivotal Phase III Results Pending for
SinuNase(TM) and BiovaxID(TM)
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) today announced that the
Company has filed its Annual Report (Form 10-K) with the SEC, reporting
the results of its operations for the fiscal year ended September 30,
2007.
Accentia’s primary focus is dedicated to the
late-stage, Phase III clinical development of its three potential
blockbuster therapeutics, which target multiple, multi-billion dollar
markets: SinuNase™ for the treatment of
chronic sinusitis; Revimmune™ for the
treatment of up to 80 autoimmune diseases, with an initial indication of
multiple sclerosis; and BiovaxID™, a
personalized anti-cancer vaccine initially targeting non-Hodgkin’s
lymphoma. Phase 3 trial results for SinuNase and BiovaxID are scheduled
to be reported in the first half of 2008, with positive data expected to
accelerate U.S. and European regulatory approvals.
Based on the many significant milestones achieved in 2007, and the
growth outlook for 2008, Accentia’s Chairman
and CEO, Dr. Frank O’Donnell, plans to issue
a comprehensive “Letter to Shareholders”
in early January. Dr. O’Donnell will provide
further insights, outlining the Company’s
strategic vision and goals, as the Company strives to deliver
breakthrough, “disruptive”
drug products and technologies to patients with chronic and
life-threatening unmet medical needs.
Financial Review:
Accentia has two operating segments consisting of specialty
pharmaceuticals (Accentia Pharmaceuticals) and product development and
market services (Analytica International). Accentia also has an
approximate 76% interest in Biovest International, Inc. (OTCBB:BVTI),
which is consolidated for reporting purposes with Accentia’s
product development and market service business.
On a fully consolidated basis, including Biovest, net sales for fiscal
2007 were $18.3 million, compared with $25.1 million in the prior fiscal
year. This decrease is primarily attributed to: a decrease in net sales
for our Specialty Pharmaceuticals segment, largely due to a strategy
shift resulting in the divestiture of our Xodol and Histex product lines
in order to focus on products with higher growth potential; and to a
lesser extent due to a decrease in net sales in Analytica and Biovest.
Consolidated research and development costs were $19.9 million for the
year, an increase of $5.3 million, or 36%, over the same twelve-month
period in 2006. This increase included $9.7 million in SinuNase
development compared to $2.5 million for the same period last year,
attributed to its Phase 3 clinical trial. Our Biovest subsidiary
research and development expense decreased to $10.2 million for its 2007
fiscal year from $12.0 million over the same twelve-month period in 2006.
Accentia’s net loss for the year ended
September 30, 2007, on a fully consolidated basis, including Biovest,
was $76.0 million, compared to $43.4 for the same twelve-month period in
2006. Of this, $38.3 million was due to non-cash expenses. This
increased loss was attributed to factors including those incurred from:
increased research and development expenses related to the SinuNase
Phase 3 clinical trial; increased interest expense; loss on sale of
assets; embedded derivative accounting for convertible debt financing
transactions; and extinguishment of debt.
The fully consolidated loss per share for the year ended September 30,
2007 was $2.21, of which $1.11 per share was the result of non-cash
charges and $0.95 per share reflected losses by Biovest, which are
consolidated in Accentia’s financial
statements, although since February 2007, Biovest has been self-funded.
For the comparable 2006 year, the fully consolidated loss per share for
the year was $1.56, of which $0.23 or $6.4 million was the result of
non-cash charges and $.49 per share reflected losses by Biovest. Per
share figures are based on 34,424,555 weighted average shares
outstanding for 2007, and 27,890,825 weighted shares outstanding for
2006.
At September 30, Accentia had $1.6 million of cash on hand, and
approximately 73.1 million shares of Biovest, which had a market value
of approximately $36.5 million. Subsequent to fiscal year-end, Accentia
received proceeds from warrant exercises that yielded $4.6 million, a $4
million extension of its secured credit line, and a renewal and
expansion of its pre-existing Hopkins Capital Group II, LLC unsecured
credit facility providing net access to an additional $6.5 million in
addition to the $4.2 million that has previously been accessed. In
addition, as previously announced, Biovest secured an $8.5 million
financing.
In other news, Accentia announced, that effective December 31, 2007,
Todd D. Thomason resigned as a Director of the Company, as a consequence
of his decision to accept employment with a company in the healthcare
industry. Mr. Thomason’s resignation was not
a result of any disagreement with the Company or related to its
operations, policies or practices.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a vertically integrated
biopharmaceutical company focused on the development and
commercialization of drug candidates that are in late-stage clinical
development and typically are based on active pharmaceutical ingredients
that have been previously approved by the FDA for other indications.
Usually these drug candidates can access the accelerated 505(b)(2)
regulatory approval pathway, which is generally less time-consuming and
less expensive than the typical 505(b)(1) pathway that must be used for
new chemical entities. The Company's lead product candidate is SinuNase™,
a novel application and formulation of a known therapeutic to treat
chronic rhinosinusitis. SinuNase has been granted Fast Track status by
the FDA and it is currently in a pivotal Phase 3 clinical trial. During
this fiscal year, the Company also plans to file an Investigative New
Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune™,
to treat numerous autoimmune diseases with an initial indication
targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune
is based on pulsed, ultra-high dosing of a well-known chemotherapeutic
agent under a risk management program. Additionally, through an
investment strategy, the Company has acquired the majority ownership
interest in Biovest International, Inc. (OTCBB:BVTI) and a royalty
interest in Biovest's lead drug candidate, BiovaxID™
and any other biologic products developed by Biovest. Biovest is
currently conducting a pivotal Phase 3 clinical trial for BiovaxID which
is a patient-specific anti-cancer vaccine focusing on the treatment of
follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track
status by the FDA. In addition to these product candidates, the Company
has a specialty pharmaceutical business, which markets products focused
on respiratory disease and an analytical consulting business that serves
customers in the biopharmaceutical industry.
For further information, please visit http://www.Accentia.net.
Forward-Looking Statements
Statements in this release that are not strictly historical in nature
constitute "forward-looking statements." Such statements include, but
are not limited to, statements about Revimmune(TM), SinuNase(TM),
BiovaxID(TM), AutovaxID(TM), SinuTest(TM) and any other statements
relating to products, product candidates, product development programs,
the FDA or clinical study process including the commencement, process,
or completion of clinical trials or the regulatory process. Such
statements may include, without limitation, statements with respect to
the Company's plans, objectives, expectations and intentions, and other
statements identified by words such as "may," "could," "would,"
"should," "believes," "expects," "anticipates," "estimates," "intends,"
"plans," or similar expressions. Such forward-looking statements involve
known and unknown risks, uncertainties, and other factors that may cause
the actual results of Accentia to be materially different from
historical results or from any results expressed or implied by such
forward-looking statements. These factors include, but are not limited
to, risks and uncertainties related to the progress, timing, cost, and
results of clinical trials and product development programs;
difficulties or delays in obtaining regulatory approval for product
candidates; competition from other pharmaceutical or biotechnology
companies; and the additional risks discussed in filings with the
Securities and Exchange Commission. All forward-looking statements are
qualified in their entirety by this cautionary statement, and Accentia
undertakes no obligation to revise or update this news release to
reflect events or circumstances after the date hereof. The product names
used in this statement are for identification purposes only. All
trademarks and registered trademarks are the property of their
respective owners.
Accentia Biopharmaceuticals, Inc.,
Tampa Douglas Calder, Director of Investor Relations & Public
Relations, 813-864-2554, ext.258 dwcalder@accentia.net or Susan
Bonitz, Ph.D., 813-864-2554, ext.277 sbonitz@accentia.net
