Avigen (MM) (NASDAQ:AVGN)
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Avigen Reports 2003 Year-End Cash and Investments at $99 Million
Clinical Development Pipeline Makes Progress
ALAMEDA, Calif., Feb. 11 /PRNewswire-FirstCall/ -- Avigen, Inc. today reported
financial results for the year ended December 31, 2003. Atyear-end, Avigen had
approximately $99 million in cash, cash equivalents, available-for-sale
securities and restricted investments. This compares with approximately $119
million at December 31, 2002.
"In 2003, Avigen continued to push forward with a strategic expansion of its
product development portfolio of gene-based therapies for serious chronic
conditions," said John Monahan, Ph.D., Avigen's president and CEO. "We continue
to focus our efforts on programs that leverage our hematological and
neurological expertise, as well as our DNA and vector manufacturing platforms."
"Our clinical trial of Coagulin-B(R), our treatment for hemophilia-B, received
clearance from the FDA to resume clinical testing," added Monahan, "I am also
delighted to report that subject enrollment has resumed and that we have added a
third clinical site. In addition to Stanford University Medical Center and The
Children's Hospital of Philadelphia, the University of Pittsburgh was added to
help accelerate subject enrollment."
In 2003, Avigen also significantly advanced its neurological programs. The
company filed an investigational new drug (IND) application with the FDA for
AV201, a treatment for advanced Parkinson's disease, and is currently responding
to a requestfor more information. Other preparatory aspects of the trial have
been completed or continue to move forward in anticipation of receiving FDA
clearance to begin the trial. These include subject accrual, manufacture of
clinical-grade AV201 product andsupport of clinical and medical staff at the
company's University of California, San Francisco clinical site.
In addition, Avigen expanded its pipeline by strategically adding a new
development program for the treatment of neuropathic pain. The company
exclusively licensed intellectual property relating to the treatment of
neuropathic pain using anti-inflammatory cytokines, including interleukin 10
(IL-10), from the University of Colorado as part of a collaboration with the
laboratory of Dr. Linda Watkins, a noted leader in the field of neuropathic pain
research.
Organizationally, Avigen took several steps to strengthen its clinical and
research teams with the recent appointments of Dawn McGuire, M.D., as the
company's Chief Medical Officer and Kirk Johnson, Ph.D. as Associate Vice
President for Preclinical Development. These appointments complement Avigen's
existing expertise and strengthen its clinical and regulatory functions with the
personnel required to move its programs forward.
Finally, Avigen's already extensive intellectual property position was further
enhanced with the grant of six new patents in the areas of AAV-mediated
treatment of hemophilia, Parkinson's disease, lysosomal storage diseases, and
cardiomyopathy, as well as AAV purification technology.
"Looking at the year ahead, I am optimistic about the opportunities before us to
continue to build our expertise in the use of gene-based therapy and other
technologies for central nervous system diseases such as neuropathic pain and to
make progress in the clinic towards developing effective treatments for patients
suffering from hemophilia and Parkinson's disease," Monahan concluded.
Avigen is partnered with Bayer Corporation for the development and
commercialization of Coagulin-B. Bayer is a worldwide healthcare and life
sciences company and leader in the development, manufacture and distribution of
hemophilia products Under the collaboration, Bayer will pay for all of the
clinical and manufacturing costs for the planned Coagulin-B Phase II/III
clinical trials. Bayer will help Avigen conduct those trials and take part in
the regulatory approval process worldwide.
Financials Results
For the year ended December 31, 2003, Avigen reported a net loss of $25.8
million, or $1.28 per share, compared with a net loss in 2002 of $27.7 million,
or $1.38 per share.
Avigen reported revenue of $463,000 for 2003 compared with $57,000 in 2002.
Revenue in 2003 primarily included $375,000 from the $2.5 million payment
received from Bayer in the first quarter of 2003, which is being recognized
ratably over five years. The remaining $88,000 of revenue recognized in 2003
and all of the revenue recognized in 2002 were from license fees and royalty
payments.
Total operating expenses for 2003 were $29.2 million, down from $33.0 million
for 2002, primarily reflecting lower staffing and material costs as well as
ongoing efforts to control expenses and implement operating efficiencies. Net
interest income for 2003 was $3.0 million, compared to $5.2 million in 2002,
reflecting lower average balances of interest-bearing investments and a general
decline in prevailing market interest rates between the two periods.
Fourth Quarter Financials
For the quarter ended December 31, 2003, Avigen reported a net loss of $6.8
million, or $0.34 per share, compared with $6.5 million, or $0.32 per share in
the same quarter of 2002. Revenue was $165,000 in the fourth quarter of 2003,
primarily due to the recognition of $125,000 of the $2.5million Bayer payment,
compared to $28,000 in the fourth quarter of 2002, related to license fees and
royalty payments. Total operating expenses were $7.6 million for the last
quarter of 2003, compared with $7.8 million for the last quarter of 2002. Net
interest income declined to $589,000 during the fourth quarter of 2003 from $1.2
million during the fourth quarter of the prior year.
About Avigen
Avigen, Inc., based in the San Francisco Bay Area, focuses on the development of
DNA-based drugs forserious chronic conditions. Avigen's proposed gene delivery
products are designed for direct administration to patients in order to achieve
expression of therapeutic proteins within the body. The company is actively
enrolling subjects in its clinical trial for Coagulin-B(R), Avigen's Factor IX
gene therapy product for hemophilia B, currently being conducted at the
Children's Hospital of Philadelphia, Stanford University Medical Center and the
University of Pittsburgh. Patients or physicians who would like more
information about enrollment criteria and the study should contact Avigen's
Clinical Development Department at or call 1-877-4-AVIGEN (877-428-4436).
Additional information on Avigen's proprietary gene delivery products can be
found at http://www.avigen.com/
Investors Please Note: The statements in this news release regarding Avigen's
prospects, its anticipation of receiving FDA clearance to begin its AV201
clinical trial and the potential of gene therapy are forward-looking statements.
Actual results may differ materially from current expectations due to a variety
of factors, including the difficulty of obtaining required regulatory approvals.
In addition, there are many other risks and uncertainties inherent in the
development of gene therapy products. Other risks relating to Avigen are
detailed in Avigen's Quarterly Report on Form 10-Q for the period ended
September 30, 2003, under the caption "Risk Factors" in Item 2 of Part 1 of that
report, which was filed with the SEC on November 13, 2003.
AVIGEN, INC.
SELECTED FINANCIAL INFORMATION
STATEMENTS OF OPERATIONS
(In thousands, except Three months ended Year ended
shares and per share Dec. 31, Dec. 31, Dec. 31, Dec. 31,
information) 2003 2002 2003 2002
(unaudited) (unaudited) (unaudited) (1)
Revenue $165 $28 $463 $57
Operating expenses
Research and
development 5,820 5,353 21,805 24,809
General and
administrative 1,764 2,420 7,399 8,146
Total operating
expenses 7,584 7,773 29,204 32,955
Loss from operations (7,419) (7,745) (28,741) (32,898)
Net interest income and
other expense 589 1,227 2,967 5,159
Net loss $(6,830) $(6,518) $(25,774) $(27,739)
Basic and diluted net loss
per share $(0.34) $(0.32) $(1.28) $(1.38)
Shares used in basic and
diluted per share
calculation 20,208,747 20,095,059 20,149,214 20,080,998
CONDENSED BALANCE SHEETS December 31, December 31,
2003 2002
(In thousands) (unaudited) (1)
Cash, cash equivalents and
available-for-sale securities $86,950 $107,724
Accrued interest and other current assets 1,218 1,451
Total current assets 88,168 109,175
Restricted investments 11,928 11,500
Property and equipment, net 15,641 18,726
Deposits and other assets 858 1,285
Total assets $116,595 $140,686
Current liabilities and deferred revenue 2,117 1,777
Deferred revenue - non-current 1,625 --
Long-term obligations 8,967 8,852
Stockholders' equity 103,886 130,057
Total liabilities and stockholders' equity $116,595 $140,686
(1) Derived from audited financial statements.
DATASOURCE: Avigen, Inc.
CONTACT: Thomas J. Paulson, Chief Financial Officer of Avigen, Inc.,
+1-510-748-7150, or fax, +1-510-748-7155, or
Web site: http://www.avigen.com/