AVANIR Pharmaceuticals Reports Second Quarter Fiscal 2007 Financial Results.ALISO VIEJO, Calif. -- AVANIR Pharmaceuticals (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 :AVNR AVNR Atrioventricular Nodal Reentry ) today reported financial results for the quarter ended March 31, 2007. For the second fiscal quarter of 2007, AVANIR reported a net loss of $7.9 million, or $0.20 per share (including a $2.6 million credit for adjustment of stock based compensation expense or $0.07 per share), compared with a net loss of $13.5 million, or $0.44 per share, for the comparable quarter in 2006. Revenues for the second quarter of fiscal 2007 were $5.9 million, compared with $2.5 million for the second quarter of fiscal 2006. Gross margins for the second quarter of fiscal 2007 were $3.6 million, compared to $576,000 in the same period a year ago. Revenues in the second quarter of fiscal 2007 included FazaClo([R]) net revenues of $3.8 million. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. were $11.6 million in the second quarter of fiscal 2007 (including a $2.6 million credit for adjustment of stock based compensation expense), compared with $14.7 million in the same period in fiscal 2006. "Our focus is on the late-stage clinical development of our promising drug candidate Zenvia[TM] for the treatment of Involuntary Emotional Expression Disorder (IEED IEED Involuntary Emotional Expression Disorder ) and for diabetic peripheral neuropathic (DPN DPN, in biochemistry, abbreviation for diphosphopyridine nucleotide, a coenzyme now usually called nicotinamide adenine dinucleotide, or NAD. DPN - Decomposed Petri Net ) pain - both with the potential to address significant unmet medical needs," said Keith Katkin, AVANIR's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We are working aggressively to solidify our financial position to fund our clinical development programs, which include cost cutting and restructuring measures announced in March. We are actively evaluating several strategic options simultaneously, with a goal to raise sufficient funds to finance operating expenses for the next two years, while minimizing shareholder dilution." The Company is targeting an annual net cash burn of $20 million, or an average of $5 million per quarter, inclusive of inclusive of prep. Taking into consideration or account; including. the projected costs for our planned confirmatory Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial of Zenvia for IEED but excluding any costs associated with a second Phase III Zenvia trial in DPN pain. Subsequent to the end of the second quarter of fiscal 2007 the Company completed the sale of 2.2 million shares of common stock with net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of $7.2 million and has up to $36 million remaining available for sale under an effective shelf registration statement. 2007 Fiscal Second Quarter and Recent Highlights: Clinical Programs and Pipeline * Reported positive top-line results of a Phase III study for Zenvia in diabetic peripheral neuropathic (DPN) pain where the primary endpoint was met. These data have been accepted for presentation at the International Congress on Neuropathic Pain in Berlin on June 8, 2007. The Company has requested a meeting with the U.S. Food and Drug Administration (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. ) to discuss the next study for Zenvia for the treatment of DPN pain. * Announced that based on a meeting with the FDA, the Company will conduct an additional Zenvia trial in patients with IEED to confirm that a proposed lower dose is safe and effective. Also announced agreement to initiate certain preclinical and clinical pharmacology Clinical pharmacology is the science of drugs and their clinical use. It is underpinned by the basic science of pharmacology, with added focus on the application of pharmacological principles and methods in the real world. studies involving Zenvia. The Company is currently working with the FDA on clinical trial design and expects to enroll the first patient by calendar year end. * Announced a successful conclusion to the research collaboration with Novartis for the Macrophage macrophage /mac·ro·phage/ (mak´ro-faj) any of the large, mononuclear, highly phagocytic cells derived from monocytes that occur in the walls of blood vessels (adventitial cells) and in loose connective tissue (histiocytes, phagocytic Migration Inhibitor Factor (MIF (1) (Maker Interchange Format) An alternate file format for a FrameMaker document. A MIF file is ASCII text, which can be created in another program and imported into FrameMaker. ) program. Novartis has assumed all continuing research and development activities for the MIF program with plans to further develop the lead candidate, AVP-28225. The two companies have been involved in a two-year research collaboration to identify orally active, small molecule inhibitors of MIF for the treatment of inflammatory diseases. AVANIR will receive a milestone payment if the molecule reaches the next stage of development and is eligible to receive additional milestone payments through clinical development and royalty payments on worldwide sales if the technology is ultimately commercialized. * Announced that AVANIR and AstraZeneca mutually agreed to end their research collaboration and license agreement on the Reverse Cholesterol Transport (RCT RCT Randomized Controlled Trial RCT Regimental Combat Team (infantry regiment with their own artillery, engineers, medical and tanks) RCT Rollercoaster Tycoon RCT Randomized Clinical Trial RCT Rhondda Cynon Taff ) program. The collaboration will end in the third fiscal quarter and the Company will receive no additional research funding Research funding is a term generally covering any funding for scientific research, in the areas of both "hard" science and technology and social science. The term often connotes funding obtained through a competitive process, in which potential research projects are evaluated and from this collaboration once it terminates. The Company is evaluating options for the RCT program. Company Operations * Announced that Keith Katkin, formerly Senior Vice President of Sales and Marketing, was elected President and CEO, and appointed to the Board of Directors. The Company also announced that Randall Kaye, M.D., was promoted to Senior Vice President and Chief Medical Officer from his former position as Vice President, Clinical and Medical Affairs and announced the appointment of Martin J. Sturgeon sturgeon, primitive fish of the northern regions of Europe, Asia, and North America. Unlike evolutionarily advanced fishes, it has a fine-grained hide, with very reduced scalation, a mostly cartilaginous skeleton, upturned tail fins, and a mouth set well back on the as Vice President and Chief Accounting Officer. * Craig A. Wheeler was elected Chairman of the Board of Directors effective May 3, 2007. * Reported that the Company is in discussions with several parties that have expressed interest in potentially acquiring certain Company assets, including FazaClo and several investigational compounds. These discussions remain ongoing and no definitive terms have been reached at this time. * Announced a planned reduction in headcount and payroll-related expenses associated with the end of the research collaborations and plans to sub-lease the Company's San Diego San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. facilities. Product Performance Performance for FazaClo([R]) (clozapine clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia. clo·za·pine n. , USP USP - unique sales point ), the Company's antipsychotic antipsychotic /an·ti·psy·chot·ic/ (-si-kot´ik) effective in the treatment of psychotic disorders; also, an agent that so acts. Antipsychotics are a chemically diverse but pharmacologically similar class of drugs; besides psychotic for treatment-resistant schizophrenia and reduction of recurrent suicidal behavior in patients with schizophrenia or schizo-affective disorder, in the three months ended March 31, 2007 was as follows: * Net wholesaler shipments during the quarter of $4.2 million, compared to $2.7 million in the second quarter of fiscal 2007, a quarter over quarter increase of 56%. * FazaClo total prescription volume increased 52% over the same quarter last year and 15% over the previous fiscal quarter. Balance Sheet Highlights As of March 31, 2007, we had cash and investments in securities totaling $8.7 million, including cash and cash equivalents of $5.3 million, short and long-term investments in securities of $2.2 million and restricted investments in securities of $1.2 million. After the end of the quarter, the Company reported raising additional net proceeds of approximately $7.2 million from the sale of 2.2 million shares of common stock into the open market under the offering prospectus filed with the Securities and Exchange Commission (SEC). Conference Call and Webcast Management will host a conference call with a simultaneous webcast today beginning at 8:00 a.m. Pacific time/11:00 a.m. Eastern time to discuss business developments in the second quarter of fiscal 2007. The call/webcast will feature Keith Katkin, President and Chief Executive Officer; Michael Puntoriero, Senior Vice President and Chief Financial Officer; and Randall Kaye, M.D., Senior Vice President and Chief Medical Officer. Investors are invited to listen to the live webcast by visiting AVANIR's corporate website at www.avanir.com. To listen to the live call, please go to AVANIR's website prior to the start of the call to register, download and install the necessary audio software. A webcast replay will be available on AVANIR's website for 30 days, and a telephone replay will be available through May 14, 2007, by dialing 800-642-1687 (domestic) or 706-645-9291 (international) and entering the conference ID number 5305269. About AVANIR AVANIR Pharmaceuticals is focused on developing, acquiring and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system, cardiovascular disorders, inflammation and infectious diseases infectious diseases: see communicable diseases. . AVANIR currently markets FazaClo, the only orally-disintegrating formulation of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatments for schizophrenia. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder Schizoaffective Disorder Definition Schizoaffective disorder is a mental illness that shares the psychotic symptoms of schizophrenia and the mood disturbances of depression or bipolar disorder. . For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com. AVANIR's lead product candidate for the treatment of involuntary emotional expression disorder (IEED), Zenvia, is the subject of an approvable letter from the FDA. Additionally, AVANIR recently completed a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the with Zenvia in patients with diabetic peripheral neuropathic pain where the primary endpoint was met. AVANIR has an ongoing development program with Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease. The Company's first commercialized product, Abreva([R]), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com. Forward Looking Statement Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. There can be no assurance that the Company will receive FDA regulatory approval for Zenvia or that the additional development work for Zenvia will be completed in the time periods that are anticipated. Final review decisions made by the FDA and other regulatory agencies concerning are often unpredictable and outside the influence and control of the Company. There can also be no assurance that the Company's cost-cutting measure will result in the anticipated savings or that the Company will be able to finance continued operations on attractive, or even acceptable, terms. Risks and uncertainties also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and subsequent Quarterly Reports on Form 10-Q Form 10-Q See 10-Q. , and from time-to-time in other publicly available information regarding the Company. Copies of this information are available from AVANIR upon request. AVANIR disclaims any intent to update these forward-looking statements. To be included on AVANIR's e-mail alert list; click on the link below or visit AVANIR's website: http://www.b2i.us/irpass.asp?BzID=958&to=ea&s=0 [TABLE OMITTED] [TABLE OMITTED] |
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