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). -More- Access Pharmaceuticals, Inc. Page 2 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 -More- Access Pharmaceuticals, Inc. Page 3 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. -More- Access Pharmaceuticals, Inc. and Subsidiaries CONSOLIDATED STATEMENTS OF OPERATIONS ------------------------------------- (unaudited)
Three Months ended March 31, ---------------------------- 2004 2003 ------------- ------------- Revenues Licensing revenues $ 4,000 $ 86,000 Product sales - 303,000 Royalty income 16,000 4,000 ------------- ------------- 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 ------------- ------------- Total expenses 2,084,000 2,587,000 ------------- ------------- 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) ------------- ------------ (287,000) (217,000) ------------- ------------ Net loss $(2,351,000) $(2,411,000) ============= ============ Basic and diluted loss per common share $(0.17) $(0.18) ============= ============ Weighted average basic and diluted common shares outstanding 14,200,273 13,199,900 ============= ============
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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