-----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, M4GbQdRjBeIDHUB487ocbrpDpwQx5e2LTMMEDZAMvdJd5SMm0XStaxtfVGP+Sf39 OOJ1CEhvgEtuY90SBC7YBg== 0001299933-06-000905.txt : 20060209 0001299933-06-000905.hdr.sgml : 20060209 20060209161211 ACCESSION NUMBER: 0001299933-06-000905 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060206 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060209 DATE AS OF CHANGE: 20060209 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: 06593214 BUSINESS ADDRESS: STREET 1: 11388 SORRENTO VALLEY ROAD STREET 2: STE 200 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 8586225200 MAIL ADDRESS: STREET 1: 11388 SORRENTO VALLEY ROAD STREET 2: SUITE 200 CITY: SAN DIEGO STATE: CA ZIP: 92121 FORMER COMPANY: FORMER CONFORMED NAME: LIDAK PHARMACEUTICALS DATE OF NAME CHANGE: 19920703 8-K 1 htm_10136.htm LIVE FILING Avanir Pharmaceuticals (Form: 8-K)  

 


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 6, 2006

Avanir Pharmaceuticals
__________________________________________
(Exact name of registrant as specified in its charter)

     
California 001-15803 33-0314804
_____________________
(State or other jurisdiction
_____________
(Commission
______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
11388 Sorrento Valley Road, San Diego, California   92121
_________________________________
(Address of principal executive offices)
  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   858-622-5200

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:

[  ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[  ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 1.01 Entry into a Material Definitive Agreement.

On February 6, 2006, the Compensation Committee of the Avanir Pharmaceuticals Board of Directors (the "Board") recommended, and the Board approved, a change in the compensation paid to non-employee directors. A summary of the non-employee director compensation arrangements is attached to this Form 8-K as Exhibit 10.1.





Item 2.02 Results of Operations and Financial Condition.

On February 9, 2006, Avanir Pharmaceuticals (the "Company") issued a press release announcing its results of operations for the first fiscal quarter ended December 31, 2005. 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 8.01 Other Events.

On February 6, 2006, the Corporate Governance Committee of the Board recommended, and the Board approved, certain revisions to the Company’s Corporate Governance Guidelines, including the adoption of a "majority vote" policy. Under the Company’s majority vote policy, any nominee for director who, in an uncontested election, receives a greater number of votes "against" his/her candidacy than "for", but who is nevertheless elected under the plurality vote standard of the California General Corporation Law, will be required to submit a conditional resignation to the Company. Upon receipt of any such conditional resignation, the Corporate Governance Committee will then consider the offer of resignation and other circumstances surrounding the vote and will recommend to the Board whether the resignation should be accepted. The Company’s Corporate Governance Guidelines, as amended, will be made available shortly on the Company’s website at www.Avanir.com. No portion of this website is incorporated by reference into this Current Report.





Item 9.01 Financial Statements and Exhibits.

Exhibit Description
10.1 Summary of Board Compensation
99.1 Press release, dated February 9, 2006






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.

         
    Avanir Pharmaceuticals
          
February 9, 2006   By:   Gregory P. Hanson, CMA
       
        Name: Gregory P. Hanson, CMA
        Title: VP, Finance and CFO


Exhibit Index


     
Exhibit No.   Description

 
10.1
  Summary of Board Compensation
99.1
  Press release, dated February 9, 2006
EX-10.1 2 exhibit1.htm EX-10.1 EX-10.1

Exhibit 10.1

SUMMARY OF BOARD COMPENSATION

The following is a summary of the compensation for non-employee directors serving on the Avanir Pharmaceuticals Board of Directors.

         
Annual Retainer Fee:
  Dollars ($)
Chairman of the Board
  $ 40,000  
All other non-employee directors
  $ 25,000  
Audit Committee Chairman
  $ 6,000  
Chairman of other standing Board committees
  $ 4,000  
Board and Committee Meeting Attendance Fees:
  Dollars ($)
Board meeting
  $ 1,500  
Audit Committee meeting – Committee Chairman
  $ 2,000  
Audit Committee meeting – Other than Chairman
  $ 1,500  
Standing Board Committee meeting (excluding Audit) – Committee Chairman.
  $ 1,250  
Standing Board Committee meeting (excluding Audit) – Other than Chairman
  $ 750  
 
  Fair Value of
Equity-based compensation
  Equity Award
Annual equity grant to sitting directors (3-year vesting)*
  $ 100,000  
Initial equity grant to newly elected directors (4-year vesting)**
  $ 200,000  

*   Represents a grant of restricted stock or restricted stock units with three-year vesting, subject to continued service during that time. Award shares may not be sold or transferred until the director’s service terminates (subject only to certain limited exceptions). Award will be granted following each Annual Meeting of Shareholders.

**   Represents a one-time option grant upon initial election to the board, with the value of the award to be determined pursuant to a Black-Scholes model (modified as appropriate by the Company consistent with FAS 123R). This option will vest and become exercisable over four years, subject to continued service during that time. Shares acquired upon exercise may not be sold or transferred until the director’s service terminates (subject only to certain limited exceptions).

Additionally, non-employee directors are reimbursed for their reasonable out-of-pocket expenses incurred in connection with attending Board and committee meetings and in attending continuing education seminars, to the extent that attendance is required by the Board or the committee(s) on which that director serves.

EX-99.1 3 exhibit2.htm EX-99.1 EX-99.1

Exhibit 99.1

[Avanir PHARMACEUTICALS LOGO]

AVANIR PHARMACEUTICALS REPORTS
FIRST QUARTER OF FISCAL YEAR 2006 RESULTS

San Diego, February 9, 2006 – Avanir Pharmaceuticals (AMEX: AVN.R) today reported financial results for the first quarter of fiscal 2006, ended December 31, 2005. Avanir reported a net loss for the first quarter of fiscal 2006 of $5.7 million, or $0.20 per share, compared to $7.1 million, or $0.30 per share, for the same period a year ago.

In the first quarter of fiscal 2006, Avanir continued the clinical development of Neurodex™ for the treatment of Involuntary Emotional Expression Disorder, or IEED, (also known as Pseudobulbar Affect or Emotional Lability) and Diabetic Neuropathic Pain. Subsequent to the end of the quarter, Avanir completed the submission of its new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Neurodex™, seeking marketing approval of the drug candidate for the treatment of IEED. Additionally, during the quarter the Company continued its fully sponsored R&D partnerships with AstraZeneca and Novartis International Ltd. for programs in reverse cholesterol transport and inflammation, respectively. The Company’s operating expenditures in the quarter were partially offset by revenues earned from milestones achieved and research support provided under these two license agreements and government research grants.

The first quarter of fiscal 2006 was highlighted by the following activities:

    Appointment of two new members to the Company’s Board of Directors; Craig A. Wheeler and Scott M. Whitcup, M.D.;

    Completion of two stock offerings raising a total of $35.5 million; and

    Earned a $5.0 million milestone from AstraZeneca that was received subsequent to the close of the quarter related to filing an investigational new drug application that allowed the initiation of Phase I safety studies.

Subsequent to the close of the quarter, Avanir:

    Implemented a 1-for-4 reverse stock split;

    Licensed docosanol 10% cream in Japan;

    Completed the submission of reformatted and supplemental safety data for the Company’s new drug application for Neurodex in the treatment of IEED; and

    Received approximately $4.7 million from the exercise of the Company’s outstanding Class A Warrants that were called by the Company.

Revenues of $8.1 million for the first quarter of fiscal 2006 included $5.0 million relating to the achievement of a milestone from AstraZeneca, $2.5 million in R&D research services, $582,000 in revenues that the Company recognized from the sale of abreva® royalty rights, and $85,000 from government research grants. Revenues in the first quarter of fiscal 2005 amounted to $888,000 and included $510,000 in revenues that the Company recognized from the sale of abreva royalty rights, $200,000 relating to the achievement of milestones under license agreements, and $161,000 from government research grants.

Total operating expenses for the first quarter of fiscal 2006 were $14.1 million, compared to $8.0 million in the same period a year ago. Expenditures on research and development (R&D) programs accounted for 66% and 63% of total operating expenses for the quarters ended December 31, 2005 and 2004, respectively. R&D expenses for the first quarter of fiscal 2006 amounted to $9.4 million, compared to $5.1 million for the same period a year ago, with the increase primarily attributable to the Company’s ongoing Phase III clinical trial for Neurodex for neuropathic pain. Selling, general and administrative expenses increased year-over-year, rising to $4.8 million in the first quarter of fiscal 2006, from $3.0 million in the first quarter of fiscal 2005, with the increase primarily attributable to an increase in pre-launch marketing activities for Neurodex.

Balance Sheet Highlights
As of December 31, 2005, Avanir had cash, cash equivalents, and investments in securities totaling $51.3 million (excluding the earned $5 million milestone from AstraZeneca which was received after the quarter end), compared to $27.5 million as of September 30, 2005. Net working capital balance was $44.4 million, deferred revenue was $18.6 million and shareholders’ equity was $40.9 million as of December 31, 2005. Avanir completed stock offerings in December 2005 and October 2005 that resulted in $19.4 million and $16.1 million in net proceeds, respectively.

Conference Call and Webcast
Management will host a conference call with a simultaneous webcast on February 9, 2006 at 1:30 Pacific/4:30 Eastern to discuss first quarter of fiscal 2006 operating performance. The call/webcast will feature President and Chief Executive Officer Eric Brandt, and Vice President and Chief Financial Officer Gregory P. Hanson, CMA. The webcast will be available live via the Internet by accessing Avanir’s web site at www.avanir.com. Please go to the web site at least ten minutes early to register, download and install any necessary audio software. Replays of the webcast will be available for 90 days, and a phone replay will be available through February 13, 2005 by dialing 800-642-1687 and entering the passcode 4490357.

About AVANIR
Avanir Pharmaceuticals is focused on developing and commercializing novel therapeutic products for the treatment of chronic diseases. Avanir’s product candidates address therapeutic markets that include central nervous system and cardiovascular disorders, inflammation, and infectious diseases. Avanir previously announced positive results in the second of two required Phase III clinical trials of Neurodex™, an investigational new drug for the treatment of involuntary emotional expression disorder. Additionally, Avanir has initiated a Phase III clinical trial for Neurodex as a potential treatment in patients with diabetic neuropathic pain, a second indication for Neurodex. 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
The information contained in this press release, including any forward-looking statements contained herein, should be reviewed in conjunction with the company’s most recent Annual Report on Form 10-K and quarterly report on Form 10-Q and other publicly available information regarding the Company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company’s business and technology. Forward-looking statements often contain such words like “estimate,” “anticipate,” “believe,” “plan” or “expect”. Avanir disclaims any intent or obligation to update these forward-looking statements.

     
Avanir Pharmaceuticals Contacts:
 
   
Patrick O’Brien
858-622-5216
pobrien@avanir.com
  Patrice Saxon
858-622-5202
psaxon@avanir.com

- tables to follow

1

AVANIR PHARMACEUTICALS
Summary Consolidated Financial Information (Unaudited)

                 
    Three Months Ended December 31,
    2005   2004
Consolidated Statement of Operations Data:
               
Revenues
  $ 8,144,888     $ 888,365  
 
               
Operating expenses
               
Research and development
    9,363,402       5,054,241  
Selling, general and administrative
    4,768,743       2,951,003  
Cost of product sales
          3,102  
Total operating expenses
    14,132,145       8,008,346  
 
               
Loss from operations
    (5,987,257 )     (7,119,981 )
Interest income
    328,166       121,832  
Interest expense
    (23,438 )     (21,621 )
Other income (expense), net
    10,512       (66,921 )
 
               
Loss before income taxes
    (5,672,017 )     (7,086,691 )
Provision for income taxes
    (2,417 )     (1,898 )
 
               
Net loss
  $ (5,674,434 )   $ (7,088,589 )
 
               
Net loss per share:
               
Basic and diluted (1)
  $ (0.20 )   $ (0.30 )
 
               
Weighted average number of common shares outstanding:
               
Basic and diluted (1)
    28,579,357       23,962,989  
 
               
 
  December 31, 2005   September 30, 2005
 
               
Consolidated Balance Sheet Data:
               
Cash and cash equivalents
  $ 30,801,894     $ 8,620,143  
Short-term, long-term and restricted investments in securities
    20,540,230       18,917,443  
 
               
Total cash and investments
  $ 51,342,124     $ 27,537,586  
 
               
Net working capital
  $ 44,356,945     $ 11,969,450  
Total assets
  $ 71,743,265     $ 41,401,990  
Deferred revenue
  $ 18,604,613     $ 19,158,210  
Total liabilities
  $ 30,864,103     $ 32,267,111  
Shareholders’ equity
  $ 40,879,162     $ 9,134,879  

(1) The shares outstanding and earnings per shares have been adjusted for the one-for-four split.

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