Accentia Biopharmaceuticals Reports Fiscal Second Quarter 2007 Financial Results.Company In-Licenses Revimmune for Late Stage Multiple Sclerosis Clinical Trials and Continues Phase 3 Development of SinuNase and BiovaxID TAMPA, Fla. -- Accentia Biopharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ABPI ABPI Association of the British Pharmaceutical Industry ABPI Associação Brasileira da Propriedade Intelectual (Brazilian Intellectual Property Association; Brazil) ABPI Ankle Brachial Pressure Index ; Accentia) has released the financial results for its fiscal 2007 second quarter, ended March 31, 2007. During the second quarter of fiscal 2007, the Company's primary focus was the continued development of its product pipeline, including the in-licensing of Revimmune[TM], a patent-pending pharmaceutical treatment in late-stage development for Multiple Sclerosis, and the ongoing Fast Tracked Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. for SinuNase[TM], a potential blockbuster intranasal in·tra·na·sal adj. Within the nose. Amphotericin B amphotericin B (ăm'fətĕr`ĭsĭn), antibiotic that halts the growth of several disease-causing fungi. Discovered in 1956, it is produced by bacteria of the genus Streptomyces. formulation for Chronic Sinusitis chronic sinusitis Chronic sinus infection ENT Inflammation of the sinuses that empty into the nasal cavity Etiology Allergic rhinitis, nasal obstruction, deviated nasal septum, tooth abscesses, URIs (CS). Through its majority-owned subsidiary majority-owned subsidiary A firm in which more than 50% of outstanding voting stock is owned by the parent company. , Biovest International, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BVTI; Biovest), the Company also focused on the Phase 3 clinical trial for BiovaxID[TM], a late-stage personalized anti-cancer vaccine in development for follicular fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma . Accentia has two business segments: a specialty pharmaceuticals segment, which markets products focused on respiratory disease Noun 1. respiratory disease - a disease affecting the respiratory system respiratory disorder, respiratory illness adult respiratory distress syndrome, ARDS, wet lung, white lung - acute lung injury characterized by coughing and rales; inflammation of the , and a biopharmaceuticals development division, which is focused on the development of drug candidates that are in late-stage clinical development, and which includes Biovest, the Company's majority owned subsidiary. Within the biopharmaceuticals development division, the Company also has an analytical consulting business, Analytica International, which serves customers in the biopharmaceutical industry. Financial Review Through an investment strategy, the Company owns a majority interest in Biovest and a royalty interest royalty interest The proportional ownership interest by the owner of oil and gas rights in income produced by the asset. See also overriding royalty interest. in Biovest's lead drug candidate, BiovaxID. Due to its majority ownership, Biovest's financial statements are consolidated with Accentia for reporting purposes. As previously announced, Biovest will continue to seek financing from sources other than the Company to 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 Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight for the three months ended March 31, 2007 were $4.6 million, compared with $7.1 million for the same period ended March 31, 2006. The decline in net sales was largely a result of the divestiture of two non-core products, Xodol and Histex, in the specialty pharmaceuticals segment, and a strategic decision within our Analytica International consulting services business to focus on smaller, more profitable contracts. As a consequence of product line divestitures, net sales in the specialty pharmaceutical segment were down $1.4 million compared to the second quarter in 2006. This resulted in a $0.8 million reduction in gross margin for the segment, which was offset by a $1.3 million reduction in sales and marketing expenses in the segment. The reduction in expenses reflects the impact of the Company's decision to realign re·a·lign tr.v. re·a·ligned, re·a·lign·ing, re·a·ligns 1. To put back into proper order or alignment. 2. To make new groupings of or working arrangements between. its products and sales efforts to strategically position the Company in the area of respiratory products in anticipation of the potential future approval of SinuNase. Revenues within Analytica International declined $0.3 million during the quarter, compared to the same quarter a year ago, which was offset by a decline in the cost of its services. Research and development costs for the Company for second quarter were $5.5 million, compared with $3.0 million for the same quarter in 2006, representing an 83% increase. The increase was primarily attributable to continued activity in the Company's clinical trials with SinuNase and the consolidated expenditures of Biovest with regard to BiovaxID. Accentia's second quarter net loss, on a fully consolidated basis, including Biovest, was $8.0 million, compared with $13.8 million reported for the comparable period in 2006. Net non-cash income of $1.4 for the quarter consisted primarily of an $8.8 million derivative gain, which was offset by an inducement loss of $4.5 million relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc certain convertible debenture Convertible Debenture Any type of debenture that can be converted into some other security. Notes: For example, a convertible bond can be converted into stock. transactions, and $1.1 million in stock compensation expense. The fully consolidated loss per share for the quarter was $0.25, compared with a consolidated loss per share of $0.47 for the same period last year. The loss in Biovest, including cash and non-cash losses, contributed $0.17 to the consolidated loss per share, compared with a $0.09 loss per share contribution from Biovest for the comparable period last year. On a fully consolidated basis, as of March 31, 2007, Accentia's capital resources were approximately $21.0 million, consisting of cash, restricted cash, and availability under lines of credit. Of this, $2.0 million was cash held by Biovest. The financial statements for the second quarter of fiscal 2007 were reviewed by the Company's auditors, Aidman aid·man n. A member of an army medical corps attached to a field unit. Piser & Co. Consistent with the Company's quarterly financial statements for 2005, 2006 and the first quarter of 2007, Aidman Piser has again issued its opinion subject to a going concern disclaimer, reflecting the continued developmental stage of Accentia's consolidated businesses. About Accentia Biopharmaceuticals, Inc. Accentia Biopharmaceuticals, Inc. and its subsidiaries (collectively referred to as the "Company" or "Accentia") 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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[TM], 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 Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. ("Biovest"), (BVTI.OB) and a royalty interest in Biovest's lead drug candidate, BiovaxID[TM] 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. 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), CRSFungal Profile(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 Top 100 Biotechnology Companies The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical 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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