Exhibit 99.1
ACCESS NEWS
Contact: Company Contact: Investor Relations
Kerry P. Gray Steve Laird
President & CEO Genesis Select
(214) 905-5100 (203) 341-0214
Donald C. Weinberger
Wolfe Axelrod
(212) 370-4500
ACCESS PHARMACEUTICALS, INC. ANNOUNCES
FIRST QUARTER FINANCIAL RESULTS
DALLAS, TEXAS, May 17, 2004, ACCESS PHARMACEUTICALS, INC. (AMEX:AKC) today
reported results for the first quarter ended March 31, 2004. The Company
reported a net loss of $2,351,000 or $0.17 per share, for the first quarter,
as compared to a net loss of $2,411,000, or $0.18 per share, for the
corresponding quarter in 2003.
Revenue for the first quarter of 2004 was $20,000 compared to $393,000 for
the comparable quarter in 2003. This decrease in revenue reflects no product
sales of Aphthasol(R) in the United States in 2004 due to the previously
reported Aphthasol(R) supply interruption ($303,000) and a reduction in the
recognition of licensing revenue ($82,000). Offsetting the reduced revenue
was a decrease in operating expenses of $503,000. This reduction occurred
as a result of decreased research and development expenses ($653,000) and
a reduction in the cost of product sales ($83,000) which was partially
offset by increased general and administrative expense ($217,000). The
reduction in research and development expense is principally attributable to
the cost incurred in 2003 to complete the OraDisc(TM) A Phase III clinical
study. The increase in administrative expenses is primarily comprised of
three components; investor relations ($72,000), patent expense, ($62,000)
and legal expense ($56,000).
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Access Pharmaceuticals, Inc.
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Commenting on the results, Kerry P. Gray, President & CEO of Access, stated,
"Operating expenses were generally in line with our 2004 plan, despite the
increased administrative expenses. It is anticipated that during the
remainder of this year we expect revenues will increase as shipments of
Aphthasol(R) resumes licensing milestones are received and increased
revenues are generated on currently marketed products."
Significant progress has been made during the past months to advance the
Company's priority activities, including:
- - Licensing an OraDisc(TM) application to Wyeth Consumer Healthcare.
- - Significant commercial expansion in our OraDisc(TM) activities.
- - Conclusion of dose escalation in our AP5346 Phase I clinical study and
the presentation of preclinical data at the recent American Association of
Cancer Research meeting.
- - Approval by the FDA and the UK authorities of the manufacturing
facility for the production of Aphthasol(R).
- - Entering two research collaborations for the evaluation of our pre-
clinical technologies.
- - Commencement of the FDA review of OraDisc(TM) A and the
inspection of the OraDisc(TM) manufacturing facility by the FDA.
- - Expansion of the commercialization of Zindaclin(R).
- - Completion of a $9.7 equity financing.
Mr. Gray continued, "This is a very exciting time at Access. The
development of our products and technologies have advanced to a point
where tangible developmental, regulatory and commercial milestones are
being reached on an ongoing basis. The progress being made both
scientifically and commercially should result in additional collaborations
being established over the balance of this year."
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
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
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Access Pharmaceuticals, Inc.
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statements made relating to the expected increases in revenues, resumed
shipments of Aphthasol(R), future licensing milestones, and the
establishment of additional collaborations. 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, 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(R) 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 the year ended December 31, 2003, 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)
Three Months ended March 31,
----------------------------
2004 2003
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Revenues
Licensing revenues $ 4,000 $ 86,000
Product sales - 303,000
Royalty income 16,000 4,000
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Total revenues 20,000 393,000
Expenses
Research and development 1,144,000 1,797,000
Cost of product sales 26,000 109,000
General and administrative 754,000 537,000
Depreciation and amortization 160,000 144,000
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Total expenses 2,084,000 2,587,000
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Loss from operations (2,064,000) (2,194,000)
Other income (expense)
Interest and miscellaneous income 33,000 98,000
Interest expense (320,000) (315,000)
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(287,000) (217,000)
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Net loss $(2,351,000) $(2,411,000)
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Basic and diluted loss per common share $(0.17) $(0.18)
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Weighted average basic and diluted
common shares outstanding 14,200,273 13,199,900
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BALANCE SHEET DATA
-------------------
March 31, 2004 December 31, 2003
-------------- --------------
(unaudited)
Cash and cash equivalents $ 8,356,000 $ 727,000
Short-term investments and
certificates of deposit 939,000 1,860,000
Restricted cash 850,000 649,000
Accounts receivable and inventory 1,297,000 1,257,000
Total assets 18,496,000 11,811,000
Working capital 8,022,000 1,206,000
Convertible notes and other obligations 14,136,000 14,361,000
Accumulated deficit (56,581,000) (54,227,000)
Total stockholders equity (deficit) 953,000 (5,825,000)
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