-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Gukp0SXdID+i2reZinN/EUVsptmW0Fw8nDThujR+1Waziq1yGM9pNBKsGCDX69g/ t6wGjKidpn/DFKvhP4IXsw== 0000936392-07-000101.txt : 20070209 0000936392-07-000101.hdr.sgml : 20070209 20070209165659 ACCESSION NUMBER: 0000936392-07-000101 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070209 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070209 DATE AS OF CHANGE: 20070209 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AVANIR PHARMACEUTICALS CENTRAL INDEX KEY: 0000858803 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330314804 STATE OF INCORPORATION: CA FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-15803 FILM NUMBER: 07598716 BUSINESS ADDRESS: STREET 1: 101 ENTERPRISE STREET 2: SUITE 300 CITY: ALISO VIEJO STATE: CA ZIP: 92656 BUSINESS PHONE: 949-389-6700 MAIL ADDRESS: STREET 1: 101 ENTERPRISE STREET 2: SUITE 300 CITY: ALISO VIEJO STATE: CA ZIP: 92656 FORMER COMPANY: FORMER CONFORMED NAME: LIDAK PHARMACEUTICALS DATE OF NAME CHANGE: 19920703 8-K 1 a27254e8vk.htm FORM 8-K Avanir Pharmaceuticals
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): February 9, 2007
Avanir Pharmaceuticals
(Exact name of registrant as specified in its charter)
         
California   001-15803   33-0314804
         
(State or other jurisdiction of
incorporation)
  (Commission File Number)   (I.R.S. Employer
Identification No.)
     
101 Enterprise, Suite 300, Aliso Viejo, CA   92656
     
(Address of principal executive offices)   (Zip Code)
     
Registrant’s telephone number, including area code:   (949) 389-6700
Not Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

SIGNATURES
Exhibit Index
EXHIBIT 99.1


Table of Contents

Item 2.02 Results of Operations and Financial Condition.
On February 9, 2007, AVANIR Pharmaceuticals issued a press release providing certain balance sheet highlights as of December 31, 2006. A copy of the press release is furnished herewith as Exhibit 99.1.
The information set forth under Item 2.02 and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
         
Exhibit No.   Description  
99.1
  Press release, dated February 9, 2007.
* * *

2


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SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
February 9, 2007  Avanir Pharmaceuticals
 
 
  By:   /s/ Michael J. Puntoriero    
    Michael J. Puntoriero   
    Senior Vice President and
Chief Financial Officer
 
 

3


Table of Contents

         
Exhibit Index
         
Exhibit No.   Description  
       
99.1
  Press release, dated February 9, 2007

4

EX-99.1 2 a27254exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
(AVANIR LOGO)
AVANIR PHARMACEUTICALS PROVIDES FIRST QUARTER BUSINESS UPDATE
Conference call begins at 11:00 a.m. Eastern time today
Aliso Viejo, Calif., February 9, 2007 — Avanir Pharmaceuticals (NASDAQ: AVNR) today provided a business update and announced a delay in reporting financial results for the first quarter of fiscal year 2007, ended December 31, 2006. The Company is currently evaluating the appropriate method for revenue recognition related to sales of FazaClo® (clozapine, USP). Until this evaluation is complete, the Company has delayed issuing a news release and filing a Form 10-Q for the quarter; the Company expects that this evaluation will be completed, and that financial results will be released, by February 14, 2007.
Business Results
The three months ended December 31, 2006 was highlighted by the following events:
    FazaClo net wholesaler shipments of $2.7 million, with 46% growth in total prescription and 67% growth in new prescriptions over the same quarter last year.
 
    Received an approvable letter from the U.S. Food and Drug Administration (“FDA”) for Zenvia™ for the treatment of involuntary emotional expression disorder (“IEED”). We have a meeting scheduled with the FDA in late February and will provide an update on the Company’s development plans for Zenvia once that is determined.
 
    Completed an equity offering raising (net) proceeds of $14.4 million. As required by the note obligation associated with our acquisition of Alamo Pharmaceuticals, we used $2.9 million of the funds raised to repay part of this outstanding debt.
 
    Announced initiatives to reduce ongoing operating expenses including suspending commercial efforts focused on Zenvia for involuntary emotional expression disorder; placing on hold activities associated with the selective cytokine inhibitor clinical development program; and reducing the Company’s workforce by 16%.
 
    Enrolled the last patient in the ongoing Zenvia Phase III painful diabetic neuropathy trial. Data from this trial is currently anticipated by mid-2007.
 
    Entered into an agreement for a financing facility and filed a prospectus supplement with the SEC to enable the Company to sell up to 5.7 million shares of common stock into the open market at the discretion of management. During the quarter, management used this facility to sell 243,060 shares raising net proceeds of $563,000.
Following the end of the quarter, Avanir:
    Announced receipt of an approvable letter from the FDA for a new formulation of its currently marketed antipsychotic drug FazaClo. The Company has responded to the FDA’s two chemistry, manufacturing and control data requirements and currently anticipates receiving final approval in the coming months. The new formulation, if approved, will include updated packaging as well as a new 12.5mg dosing strength.
 
    Completed and submitted the briefing package to the FDA in response to the approvable letter received for Zenvia.
 
    Sold an additional 2,329,790 shares of common stock into the open market using the prospectus supplement on file with the SEC, thereby raising net proceeds of $5.4 million.


 

Balance Sheet Highlights
As of December 31, 2006, the Company had cash and investments in securities totaling $17.6 million, including cash and cash equivalents of $14.5 million, short and long-term investments in securities of $2.2 million and restricted investments in securities of $857,000.
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 first quarter of fiscal 2007. The call/webcast will feature Eric Brandt, President and Chief Executive Officer, Michael Puntoriero, Senior Vice President and Chief Financial Officer, and other members of management. The webcast will be available live via the Internet by accessing Avanir’s website at www.avanir.com. Replays of the webcast will be available for 90 days, and a phone replay will be available through February 14, 2007 by dialing 800-642-1687 (domestic) or 706-645-9291 (international) and entering the passcode 6368181.
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. 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 schizophrenic drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenic or schizoaffective disorder. For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com. Zenvia™, Avanir’s lead product candidate for the treatment of involuntary emotional expression disorder (IEED), is the subject of an approvable letter from the FDA and future development plans for this product candidate are under consideration. The Company does not know at this time what impact, if any, the ongoing discussions with the FDA for IEED may have on the development of Zenvia for other indications. Additionally, Avanir has completed the patient recruitment in a Phase III clinical trial with Zenvia as a potential treatment for patients with painful diabetic neuropathy. Avanir has active collaborations with two international pharmaceutical companies: Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease; and AstraZeneca for the treatment of cardiovascular 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 Statements
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 continue the clinical development of Zenvia after its planned meeting with the FDA or that Zenvia will receive FDA regulatory approval for any indication. There can also be no assurance that the FDA will not require additional evidence of Zenvia’s safety and/or efficacy, notwithstanding the existence of an SPA for the Company’s neuropathic pain clinical trials. If regulatory approval is received, there can be no assurance that AVANIR will be able to market Zenvia successfully. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are often unpredictable and outside the influence and control of the Company. 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.


 

To be included on Avanir‘s e-mail alert list; click on the link below or visit Avanir‘s web site:
http://www.b2i.us/irpass.asp?BzID=958&to=ea&s=0
Avanir Pharmaceuticals Contact:
Patrick O’Brien
949-389-6789
pobrien@avanir.com
# # #

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