May 15 2006, 7:09 PM EST
News source: Business Wire
Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI) has released its financial results for the second quarter ended March 31, 2006. The Company's efforts during the period focused primarily on the development of two potential blockbuster products, SinuNase, an intranasal Amphotericin B formulation for Chronic Sinusitis (CS), and, through its majority-owned subsidiary Biovest International, Inc. (OTCBB:BVTI), BiovaxID, a personalized biologic therapeutic vaccine for follicular non-Hodgkin's lymphoma. Accentia has two business segments: specialty pharmaceuticals, and biopharmaceutical products and services. Biovest, the majority-owned subsidiary, is consolidated with Accentia for reporting purposes.Financial Review
On a fully consolidated basis, including Biovest, net sales for the second quarter of 2006 were $7.1 million, a decrease of $0.5 million, or 7%, from the same period ended March 31, 2005. This was mainly attributable to a manufacturer's product recall of Histex I/E, followed by Accentia's discontinuance of the product. Research and development costs were $3.0 million during the second quarter this year, an increase of $0.5 million, or 20%, over the same three-month period in 2005. This was the result of increased activity in the Company's clinical trials for its two major late-stage developmental products, BiovaxID and SinuNase.
Accentia's second-quarter net loss, on a fully consolidated basis, including Biovest, was $13.8 million, an increase of $6.3 million, over the three months ended March 31, 2005. Of this loss, $5.6 million, or approximately 41%, was the result of non-cash charges such as depreciation, amortization of product rights, stock-based compensation, the effect of embedded derivative liability accounting, and amortization of debt discount.
The fully consolidated per-share loss was $0.47, of which $0.19 per share was the result of non-cash charges and $0.09 per share reflected losses incurred by Biovest. On a fully consolidated basis, the Company's six-month year-to-date loss was $0.57 per share, including adjustments for derivative accounting, compared to a loss of $0.96 per share for the comparable six month period in 2005 when computed using the same number of outstanding shares as was used to compute the March 31, 2006 loss per share (when the loss per share for the six months ended March 31, 2005, is computed using the weighted number of outstanding shares for that period, which was before the Company's IPO, the loss per share was $4.67 per share).
Accentia's capital resources at the end of the second quarter of 2006 were approximately $56 million, consisting of cash, restricted cash and availability under lines of credit totaling $11.9 million and its ownership of Biovest common stock, valued March 31, 2006 at a market price of $44.2 million.
Recent Company Highlights:
"Since the start of the second quarter of our fiscal year, January 1, 2006, Accentia Biopharmaceuticals and its majority-owned subsidiary, Biovest International, have reached substantial developmental and commercial milestones," said Frank E. O'Donnell, Jr., M.D. the Company's Chairman and Chief Executive Officer.
The most noteworthy recent developments, according to the Company, are the following:
-- SinuNase granted FDA Fast Track status: Accentia was notified that the United States Food and Drug Administration (FDA) granted Fast Track status to SinuNase, the Company's intranasal Amphotericin B formulation. This was -- and still is -- the first and only CS drug candidate to receive Fast Track status from the FDA, to the best of the Company's knowledge. Accentia is preparing to commence its Phase 3 placebo-controlled clinical trial with SinuNase to treat post-surgical patients suffering from recurrent CS. The study is intended to be a four-month double-blinded
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