EXHIBIT 99.1
ACCESS NEWS
Contact: Company Contact: Investor Relations
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Kerry P. Gray Donald C. Weinberger
President & CEO Jeffrey Volk
(214) 905-5100 Wolfe Axelrod
(212) 370-4500
ACCESS PHARMACEUTICALS REPORTS FOURTH QUARTER
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AND YEAR-END RESULTS
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- Company Generates Revenues From First Product Sales,
Royalties and Licensing Payments -
DALLAS, TEXAS, March 31, 2003, ACCESS PHARMACEUTICALS, INC. (AMEX: AKC)
today reported results for the fourth quarter and full year ended December
31, 2002. The Company reported a net loss for the fourth quarter of
$2,352,000, or $.18 per share, compared to a net loss of $1,595,000, or
$.12 per share for the corresponding quarter in 2001. For the full year,
the net loss was $9,384,000 or $0.72 per share, compared with a loss
of $6,027,000, or $0.47 per share, for the year ended December 31, 2001.
Revenue in the fourth quarter was $677,000, reflecting product sales in
the United States, royalties and licensing fees. For the full year revenues
increased to $1,147,000 from $243,000 in 2001. The increase in licensing
revenues, ($610,000) principally from milestones relating to Zindaclin,
and product sales accounted for the majority of the increased revenues.
In 2002, operating expenses increased by $3,357,000. Increased expenditure
on research and development, $2,850,000, was the major contributing factor.
This increase reflects the Company's clinical trial programs, with increased
expenditure for OraDisc(TM) ($1,148,000) and polymer platinate ($997,000).
In addition, the expansion of our scientific organization, ($579,000) and the
acquisition of our Australian subsidiary ($341,000) contributed to the
increase. General and administrative expenses were $2,277,000 an increase
of $318,000 over full year 2001. Payment of $92,000 in foreign withholding
taxes on licensing payments and the write down of an investment of $50,000
were one-time events that contributed to the increased expenditure. Interest
expense associated with our outstanding convertible notes, lower interest
income due to lower cash balances from the prior year and lower interest
rates reduced other income and expenses in 2002 by $965,000 compared to 2001.
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Access Pharmaceuticals, Inc.
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Commenting on the results, Kerry P. Gray, President and CEO of Access stated,
"While our fourth quarter revenue is reported as $677,000, which reflects the
requirement to recognize licensing revenue over the period of our performance
obligations under the license, actual cash generated from licensing fees,
royalty payments and product sales was $1,396,000, which was in-line with
our previous projections. As previously reported, over the next 15-18 months
we are anticipating cash flow from ResiDerm and Amlexanox to contribute
approximately $6 million in revenue. The operating expenses, excluding the
one time items identified above, were in accordance with our operating plan."
During the past 12 months, we have continued to execute our operating plan,
and have made significant progress including:
* Acquired the vitamin mediated targeted delivery technologies
- Expanded our scientific expertise to include biology, which
has enhanced our drug development capability
- Presented data at the 2nd International Symposium on tumor targeted
delivery systems highlighting advantages of our vitamin mediated
targeted delivery approach
* Acquired the amlexanox patent and trademarks from GlaxoSmithKline
- First amlexanox product sales by Access in the fourth quarter
* Strakan launched Zindaclin(R), zinc and clindamycin complex, for the
treatment of acne, in the United Kingdom
- Strakan executed a sub-licensing agreement with Fujisawa, a major
dermatology company, to market Zindaclin(R) in continental Europe
- Received approval in seven additional European Union countries for
marketing
* Advanced the development of our polymer platinate program.
- Completed the initial Phase I clinical trial for AP5280 polymer
platinate
- Initiated a phase I/II AP5280 polymer platinate study utilizing a
weekly dosing schedule to evaluate AP5280 as a single therapy in
ovarian cancer patients
- Completed the pre-clinical development of AP5346 polymer platinate
* Initiated a 700 patient phase III OraDisc(TM) study
- Completed enrollment in early 2003
- Conducted a 100 patient 28-day safety study to support an NDA filing
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Access Pharmaceuticals, Inc.
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* Licensed Amlexanox 5% paste to Zambon Group for marketing in Germany,
France, Italy, Holland, Belgium, Luxembourg, Switzerland, Brazil and
Columbia
Mr. Gray added, "The achievements of 2002 have positioned the company for
significant revenue growth in 2003. Additionally, the advancements in
the development of our product candidates have placed us in a position to
realize additional near term revenues. Our pre-clinical technologies,
vitamin mediated targeted delivery and hydrogel particle aggregates are
exciting technologies with the data being generated continuing to show
significant promise for the development of platform technologies from which
numerous product candidates can be developed."
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), the only FDA-approved product for the treatment of canker
sores, and is developing products for mucositis and other dermatological
indications. Access is also developing unique polymer platinates for use in
the treatment of cancer and has developed, in conjunction with its partner
Strakan, Ltd., the marketed product Zindaclin(R), which utilizes ResiDerm(R),
our topical zinc delivery system that provides rapid delivery and reservoir
of a drug in the skin.
This press release contains certain statements that are forward-looking and
that involve risks and uncertainties, including but not limited to
statements made relating to, the uncertainties associated with research
and development activities, clinical trials, our ability to raise capital,
the integration of acquired companies and technologies, the timing of and
our ability to achieve regulatory approvals, dependence on others to market
our licensed products, collaborations, future cash flow, 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, OraDisc(TM) and our Mucositis technology, our
ability to develop products from our platform technologies, our ability 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 theyear ended December 31, 2002, 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
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Three months ended Twelve months ended
December 31, December 31,
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2002 2001 2002 2001
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Revenues
License revenues $ 472,000 $ 11,000 $ 853,000 $ 243,000
Product sales 194,000 - 194,000 -
Research and development - - 89,000 -
Royalty income 11,000 - 11,000 -
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Total revenues 677,000 11,000 1,147,000 243,000
Expenses
Research and development 1,809,000 844,000 7,024,000 4,174,000
Cost of product sales 107,000 - 107,000 -
General and administrative 758,000 603,000 2,277,000 1,959,000
Depreciation and amortization 147,000 114,000 439,000 418,000
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Total expenses 2,821,000 1,561,000 9,847,000 6,551,000
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Loss from operations (2,144,000) (1,550,000) (8,700,000) (6,308,000)
Other income (expense)
Interest and miscellaneous
income 121,000 273,000 594,000 1,451,000
Interest expense (329,000) (318,000) (1,278,000) (1,170,000)
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(208,000) (45,000) (684,000) 281,000
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Net loss $(2,352,000) $(1,595,000) $(9,384,000) $(6,027,000)
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Basic and diluted loss
per common share $(0.18) $(0.12) $(0.72) $(0.47)
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Weighted average basic
and diluted common
shares outstanding 13,159,119 12,863,966 13,104,060 12,856,639
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BALANCE SHEET DATA
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December 31, December 31,
2002 2001
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Cash and cash equivalents $ 1,444,000 $ 7,426,000
Short-term investments and
certificates of deposit 8,332,000 12,700,000
Accounts receivable and inventory 1,645,000 83,000
Total assets 19,487,000 25,487,000
Working capital 7,594,000 18,519,000
Convertible notes and other obligations 15,006,000 13,998,000
Accumulated deficit (47,292,000) (37,908,000)
Total stockholders equity 489,000 9,078,000
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