AVANIR Pharmaceuticals Reports Second Quarter Fiscal 2007 Financial Results
AVANIR Pharmaceuticals (NASDAQ:AVNR) 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® net revenues of $3.8 million. Total operating expenses 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™ for the treatment of Involuntary Emotional Expression Disorder (IEED) and for diabetic peripheral neuropathic (DPN) pain – both with the potential to address significant unmet medical needs," said Keith Katkin, AVANIR's President and CEO. "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 the projected costs for our planned confirmatory Phase III 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 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
Performance for FazaClo® (clozapine, USP), the Company's antipsychotic 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:
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.
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. 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. 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 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®, 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 and subsequent Quarterly Reports on Form 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.
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|May 09, 2007|