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.