Avigen (MM) (NASDAQ:AVGN)
Historical Stock Chart
From Oct 2019 to Oct 2024
Avigen Reports Results for the Three and Nine Months Ended September 30, 2003
$105 Million in Cash and Securities to Support Strategic Plan
ALAMEDA, Calif., Oct. 29 /PRNewswire-FirstCall/ -- Avigen, Inc., today
reported financial results for the three and nine months ended September 30,
2003. At September 30, 2003, Avigen had approximately $105 million in cash,
cash equivalents, available-for-sale securities and restricted investments,
compared with approximately $111 million at June 30, 2003 and $119 million at
December 31, 2002.
"Both of our key product development programs have gained momentum," said John
Monahan, Ph.D., Avigen's president and CEO. "In September, the FDA and the
Institutional Review Boards at both the Stanford University Medical Center and
the Children's Hospital of Philadelphia gave us clearance to proceed with our
clinical trial of Coagulin-B(R), our product in development for the treatment of
hemophilia-B. In October, we had a positive hearing at a meeting of the
National Institutes of Health's Recombinant DNA Advisory committee (RAC) for
AV201, our product candidate for the treatment of advanced Parkinson's disease.
Our clinical trial site team, which is made up of leading doctors and
researchers in neurology and Parkinson's disease from the University of
California at San Francisco, presented the protocol for our proposed Phase 1
clinical trial of AV201 at the meeting. Next steps for Avigen include enrolling
additional subjects in the hemophilia trial, filing an investigational new drug
application with the FDA for AV201, and beginning to enroll patients in early
2004, contingent upon FDA clearance to proceed with the AV201 Parkinson's
clinical trial."
Financial Results
For the three months ended September 30, 2003, Avigen reported revenue of
$140,000, due primarily to the recognition of $125,000 in revenue resulting 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 revenue is due to
license fees and royalty payments. Revenue in the third quarter of 2002 was
$13,000 in license fees and royalty payments.
Operating expenses declined 9 percent to $7.7 million in the three months ended
September 30, 2003, from $8.5 million in the same period in 2002, reflecting the
impact of the staff reduction in October 2002 and generally lower spending
levels, partially offset by higher payments to third-party collaborators
conducting preclinical research on our behalf.
Net interest income and other expense for the quarter ended September 30, 2003
were $629,000 compared with $1.4 million in the same period in 2002, reflecting
both lower average balances of interest-bearing investments and a general
decline in prevailing market interest rates between the two periods.
For the three months ended September 30, 2003, Avigen reported a net loss of
$6.9 million, or $0.34 per share, compared with a net loss of $7.1 million, or
$0.35 per share, in the same period in 2002.
For the nine months ended September 30, 2003, Avigen reported revenue of
$298,000, compared with $29,000 in the same period in 2002. Operating expenses
for the nine months ended September 30, 2003 were down 14% to $21.6 million,
from $25.2 million in the same period of 2002. Net loss for the nine months
ended September 30, 2003 was $18.9 million, or $0.94 per share, compared with a
net loss of $21.2 million, or $1.06 per share, in the first nine months of
2002.
About Avigen
Avigen, Inc., headquartered in the San Francisco Bay Area, is a leader in the
development of gene therapy products. Avigen's proposed gene delivery products
are designed for direct administration to patients in order to achieve
expression of therapeutic proteins within the body. Additional information on
Avigen's proprietary gene delivery products can be found at
http://www.avigen.com/.
Avigen is actively enrolling participants in its Phase I clinical study for the
treatment of hemophilia-B, an open-label, dose escalation safety trial of
Coagulin-B. Participants must have severe hemophilia B with Factor IX levels
below 1% of normal. Each will receive a single administration of Coagulin-B
infused into the liver. The trial is currently being conducted at the
Children's Hospital of Philadelphia and the Stanford University Medical Center.
Participants will then be followed at their local treatment center. Patients and
doctors who would like more information about enrollment criteria and the study
should contact the Clinical Development Department at or call at 510-748-7379.
Investors Please Note: The statements in this news release regarding Avigen's
expectations for enrolling subjects in clinical trials, Avigen's beliefs
regarding the potential of AV201 to treat Parkinson's disease, and for filing an
investigational new drug application for AV201 with the FDA or for getting
clearance from the FDA to conduct a clinical trial for the treatment of advanced
Parkinson's disease with AV201 are forward-looking statements. Actual results
may differ materially from current expectations due to a variety of factors,
including: uncertainty in obtaining or maintaining approvals required by
regulatory or institutional authorities due to unanticipated responses to the
treatment or for other reasons; unanticipated delays in preparing regulatory
filings; and Avigen may experience unexpected difficulties in enrolling suitable
trial participants, which would delay the commencement or continuation of the
trials. In addition, there are many other risks and uncertainties inherent in
the development of gene therapy products. Other risks relating to Avigen are
detailed from time to time in documents filed by Avigen with the SEC, including
Avigen's Quarterly Report on Form 10-Q for the period ended June 30, 2003, filed
on August 8, 2003, under the caption "Risk Factors" in Item 2 of Part I of that
report.
AVIGEN, INC.
SELECTED FINANCIAL INFORMATION
STATEMENTS OF OPERATIONS
(In thousands, except
shares and per share
information) Three months ended Nine months ended
Sept. 30, Sept. 30, Sept. 30, Sept. 30,
2003 2002 2003 2002
(unaudited) (unaudited)
Revenue $140 $13 $298 $29
Operating expenses
Research and
development 5,594 6,329 15,985 19,456
General and
administrative 2,084 2,144 5,635 5,726
Total operating
expenses 7,678 8,473 21,620 25,182
Loss from operations (7,538) (8,460) (21,322) (25,153)
Net interest income and
other expense 629 1,350 2,378 3,932
Net loss $(6,909) $(7,110) $(18,944) $(21,221)
Basic and diluted net
loss per share $(0.34) $(0.35) $(0.94) $(1.06)
Shares used in basic
and diluted per
share calculation 20,143,101 20,091,283 20,129,479 20,077,505
CONDENSED BALANCE SHEETS September 30, December 31,
2003 2002
(In thousands) (unaudited) (A)
Cash, cash equivalents and
available-for-sale securities $93,346 $107,724
Accrued interest and other current assets 1,641 1,451
Total current assets 94,987 109,175
Restricted investments 11,928 11,500
Property and equipment, net 16,131 18,726
Deposits and other assets 912 1,285
Total assets $123,958 $140,686
Current liabilities and deferred revenue 2,768 1,777
Deferred revenue - non-current 1,750 --
Long-term obligations 8,927 8,852
Stockholders' equity 110,513 130,057
Total liabilities and stockholders' equity $123,958 $140,686
(A) Derived from audited financial statements.
DATASOURCE: Avigen, Inc.
CONTACT: Lise Needham, Associate Director of Investor Relations of
Avigen, Inc., +1-510-748-7112, or
Web site: http://www.avigen.com/