Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), Tampa, Fla., has
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. 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 more information, visit http://www.Accentia.net or call
813/864-2554, ext.258.
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