EXHIBIT 99.1
ACCESS NEWS
Contact: Company Contact: Investor Relations
Kerry P. Gray Budd Zuckermann
President & CEO Genesis Select
(214) 905-5100 (303) 415-0200
ACCESS PHARMACEUTICALS, INC. ANNOUNCES
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THIRD QUARTER FINANCIAL RESULTS
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DALLAS, TEXAS, November 17, 2003, ACCESS PHARMACEUTICALS, INC. (AMEX : AKC)
reported its results for the third quarter and nine months ended September
30, 2003. The Company reported a net loss of $2,206,000 or $0.17 per share,
for the third quarter, as compared to a net loss of $2,858,000, or $0.22 per
share, for the corresponding quarter in 2002. The net loss for the nine month
period ended September 30, 2003 was $4,301,000 or $0.32 per share compared
with a net loss of $7,032,000 or $0.54 per share for the corresponding
period in 2002.
Due to the previously reported supply interruption of Aphthasol(R), which
was the subject of the non-recurring revenue in the second quarter 2003,
revenue in the third quarter was $11,000 compared with $89,000 in the
comparable quarter of 2002. This decrease was the result of a reduction
in research grant receipts in 2003. Operating expenses decreased $812,000
due to lower research and development expenses ($927,000) offset by an
increase in cost of product sales ($30,000) and increased administrative
expenses, principally additional professional fees ($63,000) and additional
depreciation and amortization of licenses and patents ($22,000). The decrease
in research and development expenses reflects lower product development
costs for products in clinical trials, preclinical product testing and
clinical trial expense due to the completion of our Phase III OraDisc(TM)
trial.
Revenue for the first nine months of 2003 was $1,087,000, an increase of
$617,000 over the prior year, principally due to product sales of Aphthasol(R)
in the United States of $532,000 and additional Zindaclin(R) licensing
payments. For the nine month period, operating expenses decreased to
$6,918,000, $108,000 lower
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Access Pharmaceuticals, Inc.
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than the prior nine month period. Research and development expenses decreased
$667,000 primarily as a result of completion of our Phase III OraDisc(TM)
clinical study and lower development costs for our polymer platinate
programs. Increases in the cost of product sales ($243,000), general and
administration expenses ($160,000) and depreciation and amortization
($156,000) largely offset the impact of lower research and development
expenses in the first nine months. General and administrative expenses
increased year-to-date as a result of increased patent expenses. Depreciation
and amortization increased in the same period as a result of from the
acquisition of additional capital assets and higher amortization
of acquired patents.
Kerry P. Gray, President and CEO of Access, stated, "The results are
in-line with our business plan. The reduction in our operating expenses
reflects the completion of the OraDisc(TM) A study earlier this year and
tight expense controls. Expenses are expected to remain at approximately
this level over the next several quarters while revenues are projected to
significantly increase when Aphthasol(R) sales resume, Zindaclin(R) is
introduced into additional markets and OraDisc(TM) B is launched."
Progress in the third quarter included:
- - The execution of two collaborative agreements to develop our preclinical
technologies.
- - The substantial completion of the NDA registration dossier for OraDisc(TM) A.
- - The completion of the transfer of Aphthasol(R) to a contract manufacturer
and the production of 2 initial batches.
- - The expansion and advancement of corporate partnering discussions.
- - The manufacturing scale-up of OraDisc(TM) B containing benzocaine and the
expansion of this program to develop additional formulations.
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Access Pharmaceuticals, Inc.
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- - The completion of both clinical and preclinical programs which enhance the
data supporting our developments, thus adding significant value to our
technology.
- - The launch of Zindaclin(R) in France and the execution of additional
product licenses.
Mr. Gray continued, "The recent commercial achievements and the events
anticipated to occur through mid 2004 including the planned launch
of OraDisc(TM) B should positively position the company to significantly
expand its revenue base. Establishing collaborative agreements with our
leading preclinical programs is an important step towards the validation
of these technologies."
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
statements made relating to our near-term products, the anticipated levels
of sales of Aphthasol(R), Zindaclin(R) and the launch of OraDisc B, our
ability to generate significant revenues in the future and our future level
of expenses. 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 perform under our plan to regain compliance with AMEX listing standards,
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 the year 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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(unaudited)
Three months ended Nine months ended
September 30, September 30
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2003 2002 2003 2002
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Revenues
Licensing revenues $ 4,000 $ 2,000 $ 537,000 $ 381,000
Product sales - - 532,000 -
Research and development - 89,000 - 89,000
Royalty income 7,000 - 18,000 -
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Total revenues 11,000 91,000 1,087,000 470,000
Expenses
Research and development 1,254,000 2,181,000 4,548,000 5,215,000
Cost of product sales 30,000 - 243,000 -
General and administrative 512,000 449,000 1,679,000 1,519,000
Depreciation and amortization 158,000 136,000 448,000 292,000
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Total expenses 1,954,000 2,766,000 6,918,000 7,026,000
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Loss from operations (1,943,000) (2,675,000) (5,831,000) (6,556,000)
Other income (expense)
Interest and miscellaneous
income 54,000 132,000 2,486,000 473,000
Interest expense (317,000) (315,000) (956,000) (949,000)
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(263,000) (183,000) 1,530,000 (476,000)
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Net income (loss) $(2,206,000) $(2,858,000) $(4,301,000) $(7,032,000)
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Basic and diluted loss
per common share $(0.17) $(0.22) $(0.32) $(0.54)
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Weighted average basic and
diluted common shares
outstanding 13,287,563 13,160,043 13,235,725 13,085,505
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BALANCE SHEET DATA
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September 30, December 31,
2003 2002
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(unaudited)
Cash and cash equivalents $ 446,000 $ 1,444,000
Short-term investments and
certificates of deposit 3,915,000 8,332,000
Restricted cash 678,000 468,000
Accounts receivable and inventory 910,000 1,645,000
Total assets 13,029,000 19,487,000
Working capital 3,406,000 7,594,000
Convertible notes and other obligations 14,088,000 15,019,000
Accumulated deficit (51,593,000) (47,292,000)
Total stockholders' equity (deficit) (3,508,000) 489,000
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