Avigen, Inc. (Nasdaq:AVGN), Alameda, Calif., has reported financial
results for the three and nine months ended September 30, 2006. At
September 30, 2006, Avigen had approximately $75 million in financial
assets, including cash, cash equivalents, available-for-sale securities
and restricted investments, compared with approximately $80 million at
June 30, 2006 and $70 million at December 31, 2005. More complete
financial results are set out in detail in the financial tables
attached.
"We remain focused on the timely execution of our clinical
development plans for each of our compounds," said Kenneth G.
Chahine, Ph.D., J.D., Avigen's president and CEO. "During the
third quarter, we initiated human trials on both AV650, which targets
spasticity and neuromuscular spasm, and AV411 for neuropathic pain. Each
of these compounds has innovative characteristics we believe will
differentiate them from other products and approaches for treating the
disorders they target. In particular, AV650 is unique from other
treatments for spasticity in that we believe it is non-sedating, and
AV411 represents a novel mechanism of action that is focused on the role
of glial cell activity in pain regulation.
"We have established a clear clinical development strategy for
each of these products and are on track to file additional
Investigational New Drug applications and initiate clinical trials with
different patient populations over the next six to nine months. Our
financial resources remain solid, as we continue to benefit from cost
savings stemming from the changes we made last year when we began to
shift our focus toward the needs of our current pipeline. This is
allowing us to channel more resources directly into the clinical
development of these products, which can be seen in our financial
statements.
"We believe our current compounds have significant additional
clinical utility and differentiate themselves from other products in the
market. Avigen continues to focus on ways to enhance the value of these
drugs through our execution of effective intellectual property
strategies and clinical trial plans."
Business And Financial Highlights
-- Initiated a Phase IIa exploratory therapeutic clinical trial
with AV411 at the Royal Adelaide Hospital in Adelaide, Australia for
neuropathic pain and remain on-track to file a U.S. Investigational New
Drug (IND) within the next three to six months; and
-- Initiated an initial Phase I clinical trial of AV650 to assess
the safety, pharmacokinetic profile and lack of sedation in normal
volunteers and are in discussion with the FDA on the protocol design for
a Phase II clinical trial with spasticity patients that Avigen intends
to initiate in early 2007.
Financial Results
Avigen reported a net loss of $5.7 million, or $0.23 per share, for
the three months ended September 30, 2006, compared to a net loss of
$6.8 million, or $0.32 per share, for the three months ended September
30, 2005. The 2005 period included the impact of $1.6 million of
impairment losses related to long-lived assets associated with
Avigen's previous gene therapy activities. For the nine months
ended September 30, 2006 and 2005, Avigen reported a net loss of $18.5
million, or $0.81 per share, and $21.8 million, or $1.06 per share,
respectively. The 2006 nine-month period included $3.0 million of
in-license fees related to AV650, and the 2005 nine-month period
included total impairment losses of $6.1 million ($1.6 million of which
were in the third quarter of 2005).
Third Quarter Results
Research and development expenses for the three months ended
September 30, 2006 and 2005 were approximately $4.7 million and $3.6
million, respectively. This increase in 2006 expenses primarily reflects
Avigen's initiation of clinical trials during the quarter for both
AV650 and AV411, as well as additional preclinical research to support
future Investigational New Drug (IND) applications.
General and administrative expenses were approximately $1.9 million
for both the three months ended September 30, 2006 and 2005, as
reductions during the 2006 quarter for personnel-related costs and legal
and professional services fees were offset by the recognition of
non-cash expense for share-based compensation.
At September 30, 2005, Avigen determined that long-lived assets,
representing leasehold improvements associated with a portion of its
facilities under lease through November 2010 at a net carrying value of
$1.6 million, were no longer recoverable and were, in fact, impaired.
Avigen took steps to seek to sublease these facilities and recorded an
impairment loss during the third quarter of 2005 to write down the
related carrying value of the leasehold improvements to approximate
their estimated fair value.
Net interest income and other expenses were $769,000 for the three
months ended September 30, 2006 compared to $334,000 for the same period
in 2005. This increase was primarily due to the increase in the amount
of Avigen's interest-bearing financial assets and a rise in the
average yield earned on Avigen's portfolio.
Nine-Month Results
Revenues for the nine months ended September 30, 2006 and 2005 were
$103,000 and $24,000, respectively. 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. 2005 revenue
represented license fees associated with intellectual property Avigen
has subsequently assigned to Genzyme Corporation.
Research and development expenses for the nine months ended
September 30, 2006 and 2005 were $11.3 million and $10.9 million,
respectively. This increase reflects approximately $3.0 million in
higher expenses for external research and development services
associated with Avigen's current clinical trials for AV650 and
AV411 and planned IND filings. This increase was partially offset by
reduced personnel-related costs, depreciation, and facilities overhead
as a result of actions initiated in June 2005 to reduce staff and other
costs associated with Avigen's previous gene therapy activities.
General and administrative expenses were $6.6 million and $5.8
million for the nine months ended September 30, 2006 and 2005,
respectively. The increase is primarily due to the recognition of
approximately $730,000 in non-cash expense for share-based compensation
for the 2006 nine-month period and charges for severance recorded during
the first quarter of 2006.
In-license fees during the nine months ended September 30, 2006
were $3.0 million and represented a payment in January in connection
with Avigen's in-license of the North American development and
commercial rights to AV650, compared to no in-license fees in the
corresponding period in 2005.
Impairment losses related to long-lived assets during the nine
months ended September 30, 2005 were $6.1 million and represented
Avigen's determination that the net carrying value of certain
leasehold improvements associated with portions of its facilities under
lease through May 2008 and November 2010 were no longer recoverable and
were, in fact, impaired. Approximately fifty-percent of these facilities
was subsequently subleased prior to the beginning of 2006.
Net interest income and other expenses for the nine months ended
September 30, 2006 and 2005 were $1.9 million and $965,000,
respectively.
Avigen believes its financial resources will be able to fund its
planned operating expenses for approximately two to three years. Avigen
also believes its current drug candidates have additional clinical and
commercial utility and intends to explore the development of these
opportunities as its financial resources allow.
About Avigen
Avigen is a biopharmaceutical company focused on unique small
molecule therapeutics and biologics 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. The company is
currently developing AV650 for spasticity and neuromuscular spasm and
AV411 for neuropathic pain. Additionally, the company has in development
AV513, a compound for the treatment of hemophilia A and B.
For more information, visit http://www.avigen.com or call
510/748-7372.
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