-----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, AZKq1F8Vxz+KVn4qUrX+IKrEO5mPV0mAViJWWMegExwOqo8dmgklzdrnwYERs120 03VrnrHZPLw4tsUwpOfFJg== 0001206774-07-001811.txt : 20070725 0001206774-07-001811.hdr.sgml : 20070725 20070725104101 ACCESSION NUMBER: 0001206774-07-001811 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070725 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070725 DATE AS OF CHANGE: 20070725 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: 07998319 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): July 25, 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 July 25, 2007, Avigen, Inc. issued a press release announcing its second 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 July 25, 2007, announcing Avigen’s second 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:  July 25, 2007 By:           /s/ Andrew Sauter
    Andrew Sauter
    Vice President, Finance


INDEX TO EXHIBITS

 Exhibit                 
 Number                 Description               
       99.1 

Press Release, dated July 25, 2007, announcing Avigen’s second quarter 2007 financial results.



EX-99.1 2 exhibit99-1.htm PRESS RELEASE, DATED JULY 25, 2007

Exhibit 99.1

Avigen Reports Second Quarter 2007 Financial Results

Conference Call Scheduled for 11:30 a.m. (EDT) on Wednesday, July 25, 2007

ALAMEDA, CA, July 25, 2007 – Avigen, Inc. (Nasdaq: AVGN) a biopharmaceutical company developing innovative therapies for the treatment of chronic neurological conditions, today reported financial results for its second quarter ended June 30, 2007. At June 30, 2007, Avigen had approximately $90 million in financial assets, including cash, cash equivalents, and available-for-sale securities and restricted investments, compared with approximately $66 million at March 31, 2007 and $71 million at December 31, 2006. This increase in financial assets was due to the completion of a $30.6 million public offering of common stock during the quarter. More complete financial results are detailed in the financial tables below.

“We remain true to our strategy of smart drug development as we continue to build on the momentum of our initial clinical work on each of the lead compounds in our pipeline,'' said Kenneth G. Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer. “We are moving forward with our clinical development plans for AV650 and AV411, two highly differentiated products that have potential to significantly improve the quality of life for patients compared to currently available drug options. During the quarter, we raised an additional $30.6 million through a public offering of our stock. These funds will allow us to strengthen both our clinical development programs and intellectual property strategies as we build the long-term value of these products.”

RECENT AVIGEN HIGHLIGHTS

  • Expanded Phase II clinical trial for powered effect of AV650 at 450 mg in spinal cord injury patients suffering from spasticity
     
  • Completed a drug-drug-interaction study of AV650 with normal volunteers which found the drug to be favorably tolerated, with no significant clinical adverse events
     
  • On track to complete a Phase IIa exploratory therapeutic clinical trial by year-end of AV411 in patients suffering from neuropathic pain at the Royal Adelaide Hospital in Adelaide, Australia.
     
  • Article published by “Expert Opinion on Investigational Drugs” which highlighted AV411’s unique mechanism of action as a potential first-in-class, non-opioid oral treatment for the management of multiple neurological indications, including neuropathic pain and opioid withdrawal (as reported June 26, 2007)
     
  • Completed a $30.6 million public offering of common stock at $6.94 per share, including underwriter exercise of an over-allotment option and before payment of commissions and other expenses (as initially reported April 26, 2007)

Financial Results

Avigen reported a net loss of $5.8 million, or $0.21 per share, for the quarter ended June 30, 2007, compared to a net loss of $4.8 million, or $0.21 per share, for the quarter ended June 30, 2006. For the six months ended June 30, 2007 and 2006, Avigen reported a net loss of $11.6 million, or $0.44 per share, and $12.9 million, or $0.59 per share, respectively. The 2006 six-month period included $3.0 million of in-license fees related to AV650.


Second Quarter Results

During the quarter ended June 30, 2007, Avigen completed a public offering which raised $28.5 million after underwriter fees and expenses. In connection with this offering and the exercise of the underwriters’ over-allotment option, 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.

Research and development expenses for the quarters ended June 30, 2007 and 2006 were $4.8 million and $3.6 million, respectively. This increase primarily reflects higher expenses of approximately $1.3 million directly associated with the planning and execution of multiple clinical trials for Avigen’s lead product candidates AV650 and AV411.

General and administrative expenses for the quarters ended June 30, 2007 and 2006 were $2.1 million and $2.0 million, respectively. The slight increase in the second quarter of 2007 included higher non-cash expenses for share-based compensation of approximately $87,000.

Net interest income and other expenses were $907,000 for the three months ended June 30, 2007 compared to $548,000 for the same period in 2006, which benefited from the increase in Avigen’s investment portfolio as a result of the proceeds from the stock offering during the current quarter. Sublease income was $182,000 and $141,000, respectively, during the quarters ended June 30, 2007 and 2006 and further offsets the company’s ongoing operating expenses for leased facilities.

Six-Month Results

Avigen reported no revenues for the six months ended June 30, 2007 compared to revenues of $103,000 for the six months ended June 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 six months ended June 30, 2007 and 2006 were $9.2 million and $6.6 million, respectively. This increase reflects approximately $2.5 million in higher third-party expenses associated with the planning and execution of multiple clinical trials AV650 and AV411.

General and administrative expenses were $4.3 million and $4.8 million for the six months ended June 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 six-month period ended June 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 six months 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 six months ended 2007.

Net interest income and other expenses for the six months ended June 30, 2007 and 2006 were $1.6 million and $1.1 million, respectively.

Avigen’s operating expenses for the first half of 2007 are in line with Management’s expectations. Operating expenses for the second half of 2007 are expected to increase in connection with the demands of additional 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, July 25, 2007, at 11:30 a.m. EDT (8:30 a.m. PDT). This webcast can be accessed from the Avigen website at www.avigen.com. The conference call may be accessed by dialing 866-510-0712 for domestic callers and 617-597-5380 for international callers. The participant pass code is 47304990. A web replay will also be available following the call on the company’s website until it releases its second quarter 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 47876595.

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 a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B, AV513. 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 initiating an AV650 Phase II clinical trial in spinal cord injury patients in the third quarter, its expectations regarding its 2007 operating expense levels, its expectations regarding how long its financial resources will last, 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 March 31, 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 May 10, 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 June 30,   Six months ended June 30,
    2007     2006     2007     2006
(unaudited) (Note 1) (unaudited) (Note 1)
Revenue   $ -     $ -     $ -     $ 103
Operating expenses
     Research and development 4,845 3,551 9,198 6,552
     General and administrative 2,073 1,971 4,336 4,786
     In-license fees     -       -       -       3,000  
     Total operating expenses 6,918 5,522 13,534 14,338
 
Loss from operations (6,918 ) (5,522 ) (13,534 ) (14,235 )
Sublease income 182 141 331 282
Net interest income and other expense     907       548       1,610       1,098  
Net loss   $ (5,829 )   $ (4,833 )   $ (11,593 )   $ (12,855 )
 
Basic and diluted net loss per common share   $ (0.21 )   $ (0.21 )   $ (0.44 )   $ (0.59 )
 
Shares used in basic and diluted net loss
   per common share calculation     27,427,033       23,014,205       26,267,944       21,959,027  


CONDENSED BALANCE SHEETS

June 30 December 31,
    2007     2006
(In thousands) (unaudited) (1)
Cash, cash equivalents and available-for-sale securities   $ 79,109   $ 60,340
Restricted investments - current 428 8,000
Accrued interest and other current assets     1,654     1,097  
     Total current assets 81,191 69,437
Restricted investments 10,000 2,428
Property and equipment, net 1,947 2,709
Deposits and other assets     412     443  
 
Total assets    $ 93,550   $ 75,017  
 
Current liabilities 2,399 9,970
 
Long-term obligations 9,480 1,570
Stockholders' equity     81,671     63,477  
 
Total liabilities and stockholders' equity   $ 93,550   $ 75,017  
 
(1) Derived from audited financial statements.


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