Accentia Biopharmaceuticals Reports Fiscal First Quarter 2007 Financial Results.
TAMPA, Fla. -- Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI; "Accentia") has released the financial results for its fiscal 2007 first quarter, ended December 31, 2006.
During the first quarter of fiscal 2007, the Company's primary focus was the initiation of the phase 3 clinical trial for SinuNase[TM], a potential blockbuster intranasal Amphotericin B formulation for Chronic Sinusitis (CS); and, through its majority-owned subsidiary, Biovest International, Inc. (OTCBB: BVTI; "Biovest"), the commercial launch of the AutovaxID[TM] device, and the continued development of another potential blockbuster product, BiovaxID[TM], a personalized therapeutic anti-cancer vaccine for follicular non-Hodgkin's lymphoma.
Accentia has two business segments: specialty pharmaceuticals, which is a development stage business; and biopharmaceutical products and services. Biovest, a majority-owned subsidiary of Accentia, is consolidated with Accentia for reporting purposes. As previously announced, Biovest will continue to self-finance its operations, which is expected over time to dilute Accentia's ownership to a position that eliminates consolidated financial reporting.
On a fully consolidated basis, including Biovest, net sales for the three months ended December 31, 2006 were $5.9 million, compared with $6.8 million for the same period ended December 31, 2005. The decline in net sales largely reflects the sale of the Xodol and Histex product lines during the quarter. Research and development costs were $4.4 million for the first fiscal quarter, compared with $3.2 million for the same fiscal quarter in 2006. The increase was primarily attributable to increased activity in the Company's clinical trials with BiovaxID and SinuNase.
Accentia's first quarter net loss, on a fully consolidated basis, including Biovest, was $30.6 million, compared with $0.3 million reported for the same three-month period in fiscal 2006. Of this loss, $21.6 million, or approximately 71%, was the result of non-cash charges such as the warrant expense associated with obtaining a lender's consent for certain transactions involving Biovest of $9.4 million, the fair market value adjustment of convertible debentures of $8.0 million, depreciation and amortization of intangibles of $0.4 million, stock-based compensation of $1.1 million, and amortization of debt discount of $0.4 million.
The fully consolidated per share loss for the quarter was $0.97, of which $0.68 per share was the result of consolidated non-cash charges, compared with a consolidated per share loss of $0.02 for the same period last year. The loss at Biovest, including cash and non-cash losses, was $0.76 per share, compared with $0.15 for the comparable period last year.
On a fully consolidated basis, as of December 31, 2006, Accentia's capital resources were approximately $14.4 million, consisting of cash, restricted cash, and availability under lines of credit. Additionally, as of December 31, 2006, Accentia carried an inter-Company demand note from Biovest in the amount of $8.7 million. As of December 31, 2006 Accentia also owned Biovest common shares valued in excess of $69 million, based on Biovest's market price at the close of the quarter. The financial statements for the first quarter of fiscal 2007 were reviewed by Aidman Piser & Co., which issued its opinion and continued a going concern disclaimer. The disclaimer is consistent with the Company's 2005 and 2006 quarterly financial statements, which reflect the continued developmental stage of Accentia's consolidated businesses.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development of late-stage "disruptive" clinical products, especially for already-approved drugs in new formulations and/or new indications that are patent-protected and which represent new therapeutics with greater clinical and economic value. Accentia has a portfolio of currently marketed respiratory products and a pipeline of products in clinical development. The company's lead respiratory product candidate is SinuNase(TM), which is under clinical development to treat chronic sinusitis (rhinosinusitis). SinuNase is a novel application and formulation of a known anti-fungal exclusively licensed from the Mayo Foundation for Medical Education and Research. The product has been Fast Tracked by the FDA and the Company has commenced a Phase 3 clinical trial. The Company's other lead product is BiovaxID(TM), a patient-specific anti-cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., (OTCBB:BVTI) is currently in a Fast-Tracked Phase 3 clinical trial. Additionally, the Company has a family of respiratory specialty pharmaceutical products, including MD Turbo(TM), an FDA approved, commercially available product that transforms dispensed metered-dose inhalers into a breath-activated, dose-counting inhaler. For further information, please visit www.accentia.net.
About Biovest International, Inc.
Biovest International, Inc. (OTCBB: BVTI.OB) is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and for clinical trials. In addition, Biovest develops, manufactures, and markets patented cell culture systems, including the AutovaxID, which is being developed as an automated vaccine manufacturing instrument. Biovest's therapy for follicular non-Hodgkin's lymphoma, BiovaxID, is currently in a Phase 3 pivotal clinical trial at over 20 major centers in the U.S. being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. For further information, please visit Biovest's website: http://www.biovest.com.
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 SinuNase[TM], BiovaxID[TM], AutovaxID[TM] and any other statements relating to products, product candidates, product development programs the FDA or clinical trial 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.
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|Article Type:||Financial report|
|Date:||Feb 15, 2007|
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