Axonyx (NASDAQ:AXYX)
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Axonyx, Inc. (NASDAQ: AXYX) today announced its
financial results for the fourth quarter and fiscal year ended
December 31, 2005.
Financial Results
Axonyx reported a net loss of $4,315,000, or $0.08 per share, in
the fourth quarter of 2005 as compared to $8,964,000, or $0.17 per
share, in the fourth quarter of 2004. Research and development
expenses decreased in the fourth quarter of 2005 to $2,813,000 from
$7,853,000 in the fourth quarter of 2004. The decrease is primarily
due to a $4,717,000 reduction in Phenserine program expenditures
resulting from the completion of Phenserine trials in late 2005.
General and administrative expenses decreased in the fourth quarter of
2005 to $1,249,000 from $2,212,000 in the fourth quarter of 2004. The
reduction is due to a decrease of $384,000 in expenses from OXIS
operations that are no longer consolidated with Axonyx's results
effective March 1, 2005, a decrease of $308,000 in non-cash charges
relating to stock option grants to consultants, a decline in net
payroll expenses of $151,000 reflecting no payroll bonuses in 2005,
and a reduction in other administrative expenses.
For the year ended December 31, 2005, the Company reported a net
loss of $28,614,000 or $0.53 per share compared to $28,780,000, or
$0.58 per share, during the same period in 2004. Revenue for the year
ended December 31, 2005 was $403,000 as compared to $2,275,000 for the
year ended December 31, 2004. Revenues in 2005 and 2004 were derived
from the sale of research assays and fine chemicals at OXIS, and in
2004, a licensing agreement at OXIS for $450,000. The decline in 2005
revenue reflects the fact that OXIS operations are no longer being
consolidated with Axonyx's results effective March 1, 2005. For the
year ended December 31, 2005, the Company incurred research and
development costs of $24,621,000 compared to $23,741,000 for the year
ended December 31, 2004. The increase of $880,000 primarily reflects
increased expenditures in the Posiphen(TM) and Bisnorcymserine
programs offset in part by a decline in expenses in the Phenserine
program due to the completion of the Phenserine trials in late 2005.
During 2005, Posiphen(TM) entered clinical Phase I studies and
Bisnorcymserine was in full pre-clinical development towards filing an
investigational new drug application (IND).
For the year ended December 31, 2005, the Company incurred general
and administrative costs of $5,143,000 compared to $8,250,000 for the
year ended December 31, 2004. The decrease of $3,107,000 for 2005 was
due to a decrease of $2,193,000 in expenses from OXIS operations and a
decrease of $1,930,000 in non-cash option charges relating to stock
option grants to consultants. These declines are offset in part by an
increase in professional fees of $1,105,000. The increase in
professional fees results from the utilization of additional outside
counsel, patent filing costs, legal cost related to class action
securities litigation, Sarbanes Oxley compliance and board member
fees.
As of December 31, 2005, the Company had $58,338,000 in cash, cash
equivalents and investments and $53,293,000 in working capital.
Gosse B. Bruinsma, M.D., President and Chief Executive Officer,
stated, "We finished the year with a strong balance sheet and continue
to focus on ways to drive progress in the CNS disease category. We
have delivered on a number of milestones, namely advancing
Posiphen(TM) into Phase I clinical trial and entering our first
licensing agreement for Phenserine. Looking ahead, we remain committed
to creating value for both our development programs and shareholders
through a disciplined approach to evaluating and executing on sound
opportunities."
Recent Events Update
-- On February 14, 2006, the Company reported a statistically
significant reduction in the plasma levels of beta-amyloid
1-42 (A beta-42) in healthy human subjects treated with
Phenserine for 35 days in a previously conducted Phase I
study.
-- On January 31, 2006, the Company announced that three
presentations of data on its drug development candidate,
Phenserine, and one presentation of data on its drug
development candidate, Posiphen(TM), will be made at the 9th
International Geneva/Springfield Symposium on Advances in
Alzheimer Therapy in Geneva, Switzerland, being held April
19-22, 2006. Phenserine has been in development by the Company
for the treatment of mild to moderate Alzheimer's disease (AD)
and Posiphen(TM) is currently in clinical development for the
treatment of AD progression.
-- On January 24, 2006, the Company announced the completion of
the ascending single dose Phase I trial with Posiphen(TM).
This double-blind, placebo controlled study of Posiphen in
healthy men and women sought to establish well tolerated
doses. Posiphen appears to be well tolerated at single doses
up to and including 80 mg.
-- On January 4, 2006, the Company announced that it had granted
to Daewoong Pharmaceutical Company Ltd. (Daewoong) an
exclusive license for the use of Phenserine in the South
Korean market. Under the terms of the agreement, Daewoong, at
its own costs, undertakes to pursue the product development
and regulatory work necessary for a New Drug Application (NDA)
(or its equivalent) in South Korea with respect to Phenserine
for the treatment of AD.
-- On November 29, 2005, the Company reported the results of an
additional analysis of a subgroup of patients from its two
curtailed Phase III clinical trials (AX-CL-09/010) with
Phenserine. The subgroup of patients, who received Phenserine
15mg twice daily, demonstrated a statistically significant
benefit over placebo as measured by the Alzheimer's Disease
Assessment Scale-cognitive subscale (ADAS-cog), when treated
for more than 12 weeks. Additionally, this subgroup showed a
positive trend towards improvement in the Clinical Interview
Based Impression of Change (CIBIC+) test, which approached
statistical significance.
About Axonyx
Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in
the acquisition and development of proprietary pharmaceutical
compounds for the treatment of Central Nervous System disorders. The
Company currently has three compounds in development for AD, namely
Phenserine - a potential symptomatic and disease progression treatment
of mild to moderate AD, Posiphen(TM) - a potential disease progression
treatment for AD now in Phase I, and Bisnorcymserine (BNC) - a
potential symptomatic treatment of severe AD now in
pre-Investigational New Drug (IND) stage. The Company is looking to
identify licensing partners to further the development of Phenserine.
This press release may contain forward-looking statements or
predictions. These statements represent our judgment to date, and are
subject to risks and uncertainties that could materially affect the
Company, including those risks and uncertainties described in the
documents Axonyx files from time to time with the SEC, specifically
Axonyx's annual report on Form 10-K. Specifically, with respect to our
drug candidates Phenserine, Posiphen(TM) and Bisnorcymserine, Axonyx
cannot assure that: any preclinical studies or clinical trials,
whether ongoing or conducted in the future, will prove successful, and
if successful, that the results can be replicated; safety and efficacy
profiles of any of its drug candidates will be established, or if
established, will remain the same, be better or worse in future
clinical trials, if any; pre-clinical results related to cognition and
the regulation of beta-APP will be substantiated by ongoing or future
clinical trials, if any, or that any of its drug candidates will be
able to improve the signs or symptoms of their respective clinical
indication or slow the progression of Alzheimer's disease; any of its
drug candidates will support an NDA filing, will be approved by the
FDA or its equivalent, or if approved, will prove competitive in the
market; or that Axonyx will have or obtain the necessary financing to
support its drug development programs. Axonyx cannot assure that it
will be successful with regard to identifying a (sub-) licensing
partner for any of its compounds, or that any such partner will
successfully develop or commercialize any such compound. Axonyx
undertakes no obligation to publicly release the result of any
revisions to such forward-looking statements that may be made to
reflect events or circumstances after the date hereof or to reflect
the occurrence of unanticipated events.
-0-
*T
Condensed Consolidated Statement of Operations
Three Months Ended Year Ended
December 31, December 31,
-------------------- ----------------
2005 2004 2005 2004
----------- ------------ ------------ ------------
Revenue
Licensing $ 450,000
Product sales $ 410,000 $ 403,000 1,825,000
---------------------------------------------------
Total revenue 410,000 403,000 2,275,000
Cost of product
sales 381,000 210,000 1,167,000
---------------------------------------------------
29,000 193,000 1,108,000
Costs and expenses:
Research and
development $ 2,813,000 7,853,000 24,621,000 23,741,000
Sales, general and
administrative 1,249,000 2,212,000 5,143,000 8,250,000
---------------------------------------------------
4,062,000 10,065,000 29,764,000 31,991,000
---------------------------------------------------
Loss from
operations (4,062,000) (10,036,000) (29,571,000) (30,883,000)
Interest income 519,000 430,000 2,235,000 1,235,000
Equity in loss of
OXIS (762,000) (1,017,000)
Gain (loss) on
issuance of
subsidiary stock 4,000 1,083,000 (314,000) 1,154,000
Other income 19,000 19,000
Financing fees (392,000) (856,000)
Interest expense (13,000) (2,000) (51,000)
Loss on foreign
exchange (14,000) (43,000) (109,000) (83,000)
---------------------------------------------------
Net loss before
minority interest
in subsidiary (4,315,000) (8,952,000) (28,778,000) (29,465,000)
---------------------------------------------------
Outside interest in
loss of subsidiary (12,000) 164,000 685,000
---------------------------------------------------
Net loss (4,315,000) (8,964,000) (28,614,000) (28,780,000)
---------------------------------------------------
Foreign currency
translation
adjustment 18,000 (14,000)
---------------------------------------------------
Comprehensive loss $(4,315,000)$ (8,946,000)$(28,614,000)$(28,794,000)
===================================================
Net loss per common
share - basic and
diluted (0.08) (0.17) (0.53) (0.58)
===================================================
Weighted average
shares - basic and
diluted 53,681,000 52,950,000 53,668,000 49,977,000
===================================================
Consolidated Balance Sheets
December 31,
-----------------------------
2005 2004
------------ ------------
ASSETS
Current assets:
Cash and cash equivalents $ 1,638,000 $ 10,091,000
Investments 56,700,000 80,500,000
Accounts receivable 229,000
Stock subscriptions receivable 2,250,000
Inventories 246,000
Other current assets 614,000 141,000
-----------------------------
Total current assets 58,952,000 93,457,000
Property, plant and equipment, net 49,000 116,000
Investment in OXIS 4,917,000
Technology for developed products, net 6,807,000
Patents and patents pending, net 995,000
Security deposits 124,000 19,000
-----------------------------
$ 64,042,000 $101,394,000
=============================
LIABILITIES
Current liabilities:
Accounts payable $ 4,147,000 $ 6,365,000
Accrued expenses 1,512,000 2,386,000
Note payable 160,000
-----------------------------
Total current liabilities 5,659,000 8,911,000
Outside interest in OXIS 5,945,000
STOCKHOLDERS' EQUITY
Preferred stock - $.001 par value,
15,000,000 shares authorized; none
issued
Common stock - $.001 par value,
150,000,000 and 75,000,000 shares
authorized as of 2005 and 2004,
respectively; 53,680,721 and 53,645,518
shares issued and outstanding in 2005
and 2004, respectively 54,000 54,000
Additional paid-in capital 149,466,000 149,150,000
Unearned compensation - stock options (15,000) (144,000)
Accumulated comprehensive loss (14,000)
Accumulated deficit (91,122,000) (62,508,000)
-----------------------------
Total stockholders' equity 58,383,000 86,538,000
-----------------------------
$ 64,042,000 $101,394,000
=============================
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