-----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, EWT00S5bohCGUbL6hE6Z2zjcjiiVlPDiDufpAHenyC190MG3z2OeG1LlQjIBBIZg LPhpHkWLLD0UQ0tjps8cqw== 0001206774-07-002445.txt : 20071024 0001206774-07-002445.hdr.sgml : 20071024 20071024114615 ACCESSION NUMBER: 0001206774-07-002445 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071024 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071024 DATE AS OF CHANGE: 20071024 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AVIGEN INC \DE CENTRAL INDEX KEY: 0000932903 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 133647119 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28272 FILM NUMBER: 071187317 BUSINESS ADDRESS: STREET 1: 1301 HARBOR BAY PARKWAY STREET 2: . CITY: ALAMEDA STATE: CA ZIP: 94502 BUSINESS PHONE: 5107487150 MAIL ADDRESS: STREET 1: 1301 HARBOR BAY PARKWAY CITY: ALAMEDA STATE: CA ZIP: 94502 8-K 1 avigen_8k.htm CURRENT REPORT

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): October 24, 2007

AVIGEN, INC.
(Exact name of registrant as specified in charter)

 Delaware  000-28272  13-3647113
 (State or other jurisdiction of  (Commission File Number)  (I.R.S. Employer Identification
 incorporation)    No.)

1301 Harbor Bay Parkway
Alameda, California 94502
(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (510) 748-7150

_______________________________

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))


Item 2.02. Results of Operations and Financial Condition.

     On October 24, 2007, Avigen, Inc. issued a press release announcing its third quarter 2007 financial results. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.

     The information in this Section 2.02 and in the press release attached as Exhibit 99.1 to this current report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Section 2.02 and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Avigen, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

 Exhibit                 
 Number               Description
      99.1 

Press Release, dated October 24, 2007, announcing Avigen’s third quarter 2007 financial results.



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.

    AVIGEN, INC. 
 
 
Dated:  October 24, 2007  By:        /s/ Andrew Sauter 
      Andrew Sauter 
      Vice President, Finance 


INDEX TO EXHIBITS

 Exhibit                 
 Number                 Description               
       99.1 

Press Release, dated October 24, 2007, announcing Avigen’s third quarter 2007 financial results.



EX-99.1 2 exhibit99-1.htm PRESS RELEASE, DATED OCTOBER 24, 2007, ANNOUNCING AVIGEN'S THIRD QUARTER 2007 F

Exhibit 99.1

Conference Call Scheduled for 1:30 p.m. (EDT) on Wednesday, October 24, 2007

ALAMEDA, CA, October 24, 2007 – Avigen, Inc. (Nasdaq: AVGN) a biopharmaceutical company innovating therapies for the treatment of chronic neurological conditions, today reported financial results for its third quarter ended September 30, 2007. At September 30, 2007, Avigen had approximately $85 million in financial assets, including cash, cash equivalents, and available-for-sale securities and restricted investments, compared with approximately $90 million at June 30, 2007 and $71 million at December 31, 2006. More complete financial results are detailed in the financial tables below.

“During the third quarter, we completed two more of our goals for the year by initiating our second AV650 phase II study and first U.S. AV411 trial,'' said Kenneth G. Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer. “We continue to focus on advancing each of our neurological compounds through the sequential clinical requirements of New Chemical Entities in the United States. In parallel, we complement our core development plans with other studies that expand our understanding of dosing regimens and drug interactions. We believe this approach to smart drug development allows Avigen to optimize the design of future pivotal trials, which will build value for our investors and lead to our development of products that will significantly and safely improve the quality of life for patients.”

RECENT AVIGEN HIGHLIGHTS

  • Initiated and enrolling subjects in an ongoing European multi-center AV650 Phase II trial in doses up to 900 mg in patients with spasticity associated with multiple sclerosis (as reported September 5, 2007)
     
  • Enrolling subjects in an ongoing U.S. AV650 Phase II trial in spinal cord injury patients suffering from spasticity at 450 mg, the currently approved dose level in Europe
     
  • Initiated U.S. Clinical Development for AV411 with a Phase I maximum tolerated dose study which will also assess the effect of food on drug metabolism and build on data from Avigen’s smaller Phase I and Phase IIa studies in Australia (as reported August 13, 2007)
     
  • On track to report results by year-end from the Australian AV411 Phase IIa exploratory clinical trial to assess safety, tolerability, and a preliminary indication of efficacy in patients suffering from neuropathic pain

Financial Results

Avigen reported a net loss of $6.8 million, or $0.23 per share, for the quarter ended September 30, 2007, compared to a net loss of $5.7 million, or $0.23 per share, for the quarter ended September 30, 2006. For the nine months ended September 30, 2007 and 2006, Avigen reported a net loss of $18.4 million, or $0.67 per share, and $18.5 million, or $0.81 per share, respectively. The 2006 nine-month period included $3.0 million of in-license fees related to AV650.


Third Quarter Results

Research and development expenses for the quarters ended September 30, 2007 and 2006 were $6.0 million and $4.7 million, respectively. This increase primarily reflects approximately $1.1 million in higher clinical expenses and tracks directly with the expansion of clinical trial activities for AV650 and AV411 during 2007.

General and administrative expenses for the quarters ended September 30, 2007 and 2006 were $2.0 million and $1.9 million, respectively. The slight increase in the third quarter of 2007 included higher non-cash expenses for share-based compensation of approximately $104,000.

Net interest income and other expenses were $961,000 for the three months ended September 30, 2007 compared to $769,000 for the same period in 2006. The 2007 period benefited from the increase in Avigen’s investment portfolio as a result of the proceeds from the common stock offering completed during the second quarter of 2007. Sublease income was $192,000 and $141,000, respectively, during the quarters ended September 30, 2007 and 2006, and further offsets the company’s ongoing operating expenses for leased facilities.

Nine-Month Results

During the nine months ended September 30, 2007, Avigen completed a public offering of its common stock which raised $28.5 million after underwriter fees and expenses. In connection with this offering the company issued an aggregate of 4.4 million shares of its common stock at a price to the public of $6.94 per share.

Avigen reported no revenues for the nine-month period ended September 30, 2007 compared to revenues of $103,000 for the nine months ended September 30, 2006. 2006 revenue represented income from Avigen's participation with the University of Colorado on a grant that was funded by the National Institutes of Health.

Research and development expenses for the nine months ended September 30, 2007 and 2006 were $15.1 million and $11.3 million, respectively. This increase reflects approximately $3.8 million in higher clinical expenses associated with the initiation and execution of multiple clinical trials for AV650 and AV411 during 2007.

General and administrative expenses were $6.4 million and $6.6 million for the nine months ended September 30, 2007 and 2006, respectively. The decrease is primarily due to charges during the first quarter of 2006 for severance payments of $288,000, and lower personnel-related costs for the nine-month period ended September 30, 2007, partially offset by higher non-cash expense for share-based compensation during the 2007 period.

In-license fees of $3.0 million for the nine-month period ended 2006 represented a payment in connection with Avigen’s in-license of the North American development and commercial rights to AV650. There were no in-license fees for the nine months ended 2007.

Net interest income and other expenses for the nine months ended September 30, 2007 and 2006 were $2.6 million and $1.9 million, respectively.

Avigen’s operating expenses for the nine months ended September 30, 2007 are in line with Management’s expectations. Operating expenses are expected to rise slightly in the fourth quarter of 2007 over the third quarter levels and continue to increase in 2008 in connection with the progress of ongoing clinical trials for AV650 and AV411, as well as the demands of additional future clinical trials and other product development activities. The company believes its financial resources will be able to fund its planned operating expenses for approximately two to three years.


Conference Call Information

Avigen management will host a conference call and webcast today, Wednesday, October 24, 2007, at 1:30 p.m. EDT (10:30 a.m. PDT). This webcast can be accessed from the Avigen website at www.avigen.com. The conference call may be accessed by dialing 888-396-2369 for domestic callers and 617-847-8710 for international callers. The participant pass code is 85761637. A web replay will also be available following the call on the company’s website until it releases its full-year 2007 financial results. Rebroadcast of the call will be available approximately one hour after the live call by dialing 888-286-8010 for domestic callers and 617-801-6888 for international callers. The participant pass code is 67087442.

About Avigen

Avigen is a biopharmaceutical company focused on developing and commercializing small molecule therapeutics to treat serious neurological disorders, including neuropathic pain and neuromuscular spasm and spasticity. Avigen's strategy is to complete the requirements of clinical development for each of the candidates in its product pipeline, and continue to look for opportunities to expand its pipeline through a combination of internal research, acquisitions, and in-licensing, with the goal of becoming a fully integrated commercial biopharmaceutical company that remains committed to its neurology products. Avigen is currently developing AV650 for spasticity and neuromuscular spasm and AV411 for neuropathic pain. Additionally, the company is advancing toward clinical trials AV513, a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B. For more information about Avigen, consult the company’s website at http://www.avigen.com.

Statement under the Private Securities Litigation Reform Act

The statements in this press release relating to Avigen’s plans to complete its AV411 Phase IIa clinical trial in Australia by year end, its expectations regarding the current United States Phase I trial of AV411, its expectations regarding its 2007 operating expense levels, its expectations regarding how long its financial resources will last, its expectations regarding its approach to smart drug development, and its goal of becoming a fully integrated commercial biopharmaceutical company remaining committed to its neurology products are forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the fact that development of small molecule therapeutics and other therapeutic discovery and development is a time- and resource-intensive process, which may result in the expenditure of a significant amount of time and resources with no progress towards clinical trials or marketable product resulting from the effort; the risk that Avigen will not be able to obtain regulatory approvals for its drug products, which is required prior to marketing drug products; and the risk that early positive preclinical and clinical results will not guarantee that the potential products will ultimately be effective in treating the indications for which they are developed, or exhibit the unique properties they appear to possess. In addition, there are many other risks and uncertainties inherent in the development of drug products. Other risks and uncertainties relating to Avigen are detailed in reports filed by Avigen with the Securities and Exchange Commission, including Avigen's Quarterly Report on Form 10-Q for the period ended June 30, 2007, under the caption "Risks Related to Our Business" in Item 2 of Part I of that report, which was filed with the SEC on August 8, 2007.

Contact: Michael Coffee
Chief Business Officer
Avigen, Inc.
1301 Harbor Bay Parkway, Alameda, CA 94502
Tel: 510-748-7372
Fax: 510-748-7155
E-mail:
ir@avigen.com


AVIGEN, INC.

SELECTED FINANCIAL INFORMATION

STATEMENTS OF OPERATIONS

(In thousands, except shares and per share information)     Three months ended September 30,     Nine months ended September 30, 
       2007       2006       2007       2006 
     (unaudited)     (unaudited) 
Revenue    $ -     $ -     $  -     $ 103  
Operating expenses                         
     Research and development      5,952       4,715       15,149       11,266  
     General and administrative      2,041       1,857       6,377       6,643  
     In-license fees      -       -       -       3,000  
     Total operating expenses      7,993       6,572       21,526       20,909  
 
Loss from operations      (7,993 )      (6,572 )      (21,526 )      (20,806 ) 
Sublease income      192       141       523       424  
Net interest income and other expense      961       769       2,570       1,865  
Net loss    $ (6,840 )    $ (5,662 )    $  (18,433 )    $ (18,517 ) 
 
Basic and diluted net loss per common share    $ (0.23 )    $ (0.23 )    $  (0.67 )    $ (0.81 ) 
 
Shares used in basic and diluted net loss                           
     per common share calculation      29,620,566       24,998,357       27,397,710       22,983,095  


CONDENSED BALANCE SHEETS

   September 30,   December 31, 
     2007     2006 
(In thousands)       (unaudited)       (1) 
Cash, cash equivalents and available-for-sale securities    $  74,540   $  60,340  
Restricted investments - current      428     8,000  
Accrued interest and other current assets      1,543     1,097  
     Total current assets      76,511     69,437  
Restricted investments      10,000     2,428  
Property and equipment, net      1,595     2,709  
Deposits and other assets      315     443  
 
Total assets    $  88,421   $  75,017  
 
Current liabilities      3,417     9,970  
 
Long-term obligations      9,418     1,570  
Stockholders' equity      75,586     63,477  
  
Total liabilities and stockholders' equity    $  88,421   $  75,017  

(1) Derived from audited financial statements.


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-----END PRIVACY-ENHANCED MESSAGE-----