EXHIBIT 99.1 PRESS RELEASE
Published on April 1, 2005
EXHIBIT 99.1
ACCESS NEWS
Contact: Company Contact: Investor Relations
Kerry P. Gray Donald C. Weinberger
President & CEO Wolfe Axelrod
(214) 905-5100 (212) 370-4500
ACCESS PHARMACEUTICALS, INC. ANNOUNCES
FOURTH QUARTER AND FULL-YEAR 2004 FINANCIAL RESULTS
DALLAS, TEXAS, March 31, 2005, ACCESS
PHARMACEUTICALS, INC. (AMEX: AKC) today reported
its results for the fourth quarter and full year
ended December 31, 2004. The Company reported a net
loss for the fourth quarter of $2,906,000 or $.18
per share, compared to a net loss of $2,634,000 or
$.19 per share for the corresponding quarter in
2003. For the full year the net loss was
$10,238,000 or $0.68 per share in 2004 compared to
a net loss of $6,935,000 or $0.52 per share, for
the year ended December 31, 2003. The results in
2003 include miscellaneous income of $2.3 million
resulting from the settlement of a dispute related
to the supply of Aphthasol(R).
Revenue in the fourth quarter of 2004 was $276,000
compared to $208,000 in 2003, reflecting an
increase in product sales ($245,000) and royalty
income ($8,000) offset by lower licensing revenues
($185,000). For the full year revenue decreased to
$549,000 compared with $1,295,000 in 2003. The
decrease in licensing revenues ($625,000) and
product sales ($181,000) accounted for the
decreased revenues in 2004 but were partially
offset by the increased royalty ($60,000) for
Zindaclin(R) sales.
Operating expenses in the fourth quarter of 2004
were $2,886,000 an increase of $296,000 compared
with 2003. This increase in the fourth quarter was
due to increased depreciation, amortization and
impairment ($111,000); increased production costs
($108,000) due to Aphthasol(R) sales; increased
research and development expense ($38,000),
reflecting production and testing costs for
Aphthasol(R) and startup production costs
associated with OraDisc(TM) A; and increased
general and administrative expense ($39,000). Full
year 2004 operating expenses increased $120,000 to
$9,628,000. Increased expenditures on general and
administration costs ($685,000) as a result of
higher professional fees ($339,000) in part due to
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Access Pharmaceuticals, Inc.
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Sarbanes-Oxley compliance and new business
consulting expense ($88,000), increased healthcare
consultant costs ($140,000) and patent expense
($51,000) and by increased depreciation,
amortization and impairment ($152,000) resulting
from the impairment of a license and acquisition of
additional capital assets. These increases were
offset by lower research and development expenses
($679,000) and cost of product sales ($38,000). The
reduction in 2004 research and development expense
reflects lower OraDisc(TM) A clinical development
costs ($622,000) and the completion of one of our
polymer platinate clinical trials ($374,000). These
decreases were partially offset by the expansion of
our scientific organization, ($269,000), the cost
of our Australian operations ($132,000) and higher
start-up costs for both Aphthasol(R) and
OraDisc(TM) A.
Loss from operations in the fourth quarter of 2004
was $2,610,000, an increased loss of $228,000 over
2003, and for the full year the operating loss
increased by $866,000 to $9,079,000.
Interest and other income/expense decreased by
$44,000 for the three month period ended December
31, 2004 compared with the same period in 2003.
Interest and other income/expense decreased by
$2,437,000 in 2004 compared with the same period in
2003 as a result of the previously reported
settlement agreement.
Kerry P. Gray, President and CEO of Access, stated,
"Compared with our operating plan we have been able
to maintain our expenses in line with our
projections despite a number of significant
expenses that were not planned. The major
additional expenses were Sarbanes-Oxley compliance
and a non-cash impairment charge for the write-off
of a license for a technology which in no longer a
part of our focus. In addition we engaged a
healthcare consulting firm to assist us in
evaluating our technology portfolio to focus our
efforts on maximizing shareholder value. Our
revenue was below our planned level due to delays
in the re-introduction of Aphthasol in the United
States, approval of this product in Europe and
licensing revenues."
2004 has been a year of achievement for the
company. Since the beginning of 2004 significant
progress, has been made including:
- - Receipt of FDA approval of OraDisc(TM) A.
- - Receipt of approvals in 10 European Union markets
for Amlexanox 5% paste.
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- - The publishing of positive Phase I clinical
trials results for AP5346.
- - Generation of additional preclinical data
supporting AP5346 including a study in a platinum
resistant model showing superiority to both
cisplatin and oxaliplatin.
- - Development of exciting preclinical data with
numerous chemotherapeutics demonstrating the
potential to significantly enhance the polymer
therapeutics approach in cancer therapy through
optimization of the formulation parameters.
- - The advancement towards commercialization of our
lead OraDisc(TM) products.
- - Expansion of our OraDisc(TM) technology through
additional development candidates in major market
segments and further technology improvements.
- - Significant expansion of the preclinical database
supporting our nanoparticle aggregate technology
and vitamin mediated oral delivery.
- - Execution of a licensing agreement with Wyeth
Consumer Healthcare, a division of Wyeth, granting
Wyeth the North American rights to market an OTC
product utilizing our OraDisc(TM) technology.
- - Expansion of our strategic partnering discussions.
Mr. Gray continued, "The receipt of FDA approval
for OraDisc A and the European approval for
Aphthasol were significant achievements for the
company, particularly OraDisc A, which we took from
concept to FDA approval in under four years. The
developments in our oncology program are also very
exciting, not only the positive data we continue to
generate with AP5346 but also the preclinical data
we have produced for our next generation compounds.
While we continue to expand our out-licensing
activities, we are disappointed that our product
licensing is behind where we anticipated, however,
we are optimistic that we will achieve positive
developments in the near term."
During the upcoming twelve months our plans include
the achievement of numerous commercial and
development milestones including:
- - Initiation of the next clinical development phase
for AP5346.
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- - Commencement of US clinical studies for AP5346.
- - Initiation of Phase I clinical development for
our next generation cancer compound.
- - Additional licensing agreements for a number of
our products and technologies.
- - Product launches in Europe and the US both for
existing approved products and our OraDisc(TM)
products.
- - Advancement of preclinical technologies toward
clinical development.
"We believe that benefits associated with our
achievements in 2004 will begin to be realized in
2005 with expansion of our commercial activities
taking in the United States and Europe. Our
development effort will focus on advancing our
oncology program, taking AP5346 through its next
stage of clinical development and our next
generation compound through preclinical development
and into Phase I clinical trials. Additionally, we
plan to continue to develop our OraDisc franchise
to provide an ongoing revenue stream and enhance
the value of this asset," Mr. Gray stated.
Access Pharmaceuticals, Inc. is an emerging
pharmaceutical company focused on developing both
novel low development risk product candidates and
technologies with longer-term major product
opportunities. Access markets Aphthasol(R) and is
developing products for other oral indications.
Access is also developing unique polymer platinates
for use in the treatment of cancer and has an
extensive portfolio of advanced drug delivery
technologies including vitamin mediated targeted
delivery, oral delivery, and nanoparticle
aggregates.
This press release contains certain statements that
are forward-looking within the meaning of Section
27a of the Securities Act of 1933, as amended, and
that involve risks and uncertainties, including but
not limited to statements made relating to the
result of our polymer platinate program, the
results of preclinical and clinical studies for our
polymer platinate products, projected royalty and
milestone payments, the OraDisc(TM) program
including manufacturing, marketing and sales of the
product, and our ability to achieve milestones and
near-term positive cash flow our expected
commercial and development milestones in 2005 and
our planned expansion of our commercial activities
in the US and Europe. These statements are subject
to numerous risks, including but not limited to the
uncertainties associated with research and
development activities, clinical trials, our
ability to raise capital, the timing of and our
ability to achieve regulatory approvals, dependence
on others to market our licensed products,
collaborations, future cash flow, our ability to
repay our outstanding convertible debt obligations,
the timing and receipt of licensing and milestone
revenues, projected future revenue growth and our
ability to generate near term revenues, the future
success of the Company's marketed products
Aphthasol(R) and products in development including
polymer platinate, and OraDisc(TM), our ability to
develop products from our platform technologies,
our ability
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to manufacture amlexanox products in
commercial quantities, our sales projections and
the sales projections of our licensing partners,
our ability to achieve licensing milestones and
other risks detailed in the Company's Annual Report
on Form 10-K for the year ended December 31, 2004,
and other reports filed by us with the Securities
and Exchange Commission.
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Access Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
BALANCE SHEET DATA
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