Form: 8-K

Current report filing

August 13, 2004

PRESS RELEASE 08/13/2004

Published on August 13, 2004

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
SECOND QUARTER FINANCIAL RESULTS
--------------------------------------

DALLAS, TEXAS, August 13, 2004, ACCESS PHARMACEUTICALS, INC. (AMEX: AKC)
reported its results for the second quarter and six months ended
June 30, 2004. The Company reported a net loss of $2,553,000, or $0.17
per share, for the second quarter, as compared to net income of $316,000,
or $0.02 per share, for the corresponding quarter in 2003. The net loss
for the six-month period ended June 30, 2004 was $4,904,000, or $0.33
per share, compared with a net loss of $2,095,000, or $0.16 per
share for the corresponding period in 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) which has resulted in the
interruption of product shipments in the US market.

Revenue in the second quarter of 2004 was $68,000 compared to $683,000
in the second quarter of 2003, reflecting a decrease in licensing revenues
($403,000) and product sales ($229,000). For the six-month period, revenue
decreased to $88,000 compared with $1,076,000 in the same period in 2003.
The decrease in product sales ($532,000) is the result of the Aphthasol(R)
supply interruption and reduced licensing revenues ($485,000) which
reflects the receipt in 2003 of milestone payments for Zindaclin(R)
associated with product launches. Supply of Aphthasol(R) has now been
restored with shipments to commence in the third quarter.

Operating expenses in the second quarter of 2004 were $2,244,000 a decrease
of $133,000 compared with 2003. This decline was due mainly to decreased
research and development expense of $216,000, as 2003

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Access Pharmaceuticals, Inc.
Page 2

included significant clinical development expenses associated with
OraDisc A(TM) and lower cost of product sales of $73,000 due to lower
product sales. The decrease was offset by higher general and administrative
expense in the second quarter of 2004 ($142,000) principally due to increased
professional expenses and business development consulting expense. Operating
expenses for the first six-months of 2004 decreased $636,000 to $4,328,000.
Decreased expenditures on research and development ($869,000) and cost of
product sales ($156,000) were offset by increased depreciation and
amortization ($30,000) resulting from the acquisition of additional capital
assets and general and administration costs ($359,000). The reduction in
2004 research and development expense reflects lower OraDisc(TM) A
clinical development costs ($698,000) and the completion of one of our
polymer platinate clinical trials ($472,000). These decreases are partially
offset by product development costs ($163,000), the expansion of our
scientific organization ($114,000) and the increased development activities
at our Australian operations ($111,000). The increase in general and
administration costs reflects the increase in business development expense
($61,000), investor relations expense ($45,000), non-cash warrant expense
($95,000), legal and accounting fees, in part associated with Sarbanes-Oxley
($74,000), and an increase in litigation expense ($102,000).

Other income (expense) in the second quarter of 2004 was a loss of $377,000
compared with income of $2,010,000 in 2003. As previously reported, in the
second quarter of 2003, we recorded a $2.3 million one-time non-recurring
item in Other Income. In addition to the cash received, the settlement
eliminates the requirement to pay future milestone payments that were due
under the agreement pursuant to which the Company purchased the amlexanox
assets. Also contributing to the loss in 2004 was a non-cash expense due to
the write-down of an investment in a publicly traded stock associated with
a product development agreement ($96,000).

Kerry P. Gray, President and CEO of Access, stated, "The timing of receipt
of milestone payments, the inability to supply Aphthasol(R) and the related
financial settlement received in 2003 significantly impact the year on year
comparison of results. With the resolution of the supply of Aphthasol(R)
and projected milestone payments in the second half, revenues are expected
to exceed the prior year. Except for the increase in expenses associated
with compliance with Sarbanes-Oxley and litigation and the write down in
the investment associated with a prior development program, our results
are in line with our business plan. Fortunately the bulk of our
litigation is now behind us with the settlement of the Del action."

Since our last financial report, achievements include:

- - Advancement of AP5346 toward Phase II clinical
development and continued generation of

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Access Pharmaceuticals, Inc.
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both preclinical and clinical data supporting this development.
- - Significant expansion of our OraDisc(TM) program
both in terms of development scope and commercial
and business development activities.
- - The advancement towards commercialization of our
lead OraDisc(TM) products.
- - The commercial production of Aphthasol(R) by our
contract manufacturer.
- - Generation of preclinical data supporting the
potential to enhance the polymer therapeutics
approach in cancer through optimization of
formulation parameters.
- - Filing of a patent for an injectable form of our
nanoparticle aggregate technology.
- - The successful conclusion of the Del litigation.

Mr. Gray continued, "The numerous positive advancements both in our product
development and business development activities offers exciting
possibilities. The expansion of the OraDisc(TM) opportunity is a very
important step towards Access achieving our objective of near-term positive
cash flow and generating revenues and earnings from marketed products.
Expansion of OraDisc(TM) development activities into major market segments
could accelerate the achievement of these objectives. Our polymer
therapeutics and polymer platinate programs continue to generate positive
results and the expansion of our nanoparticle aggregate technology to
include an injectable alternative offers exciting potential. Given the
progress made during the last 90 days, the Company is well positioned to
achieve numerous milestones over the balance of 2004."

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 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, the resumption of supply of Aphthasol(R), projected milestone
payments, the OraDisc(TM) program and our ability to achieve milestones.
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)

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Access Pharmaceuticals, Inc.
Page 4

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, 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 June 30, Six months ended June 30, 2004
---------------------------- ----------------------------
2004 2003 2004 2003
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Revenues
Licensing revenues $ 44,000 $ 447,000 $ 48,000 $ 533,000
Product sales - 229,000 - 532,000
Royalty income 24,000 7,000 40,000 11,000
------------- ------------- ------------- -------------
Total revenues 68,000 683,000 88,000 1,076,000

Expenses
Research and development 1,281,000 1,497,000 2,425,000 3,294,000
Cost of product sales 31,000 104,000 57,000 213,000
General and administrative 772,000 630,000 1,526,000 1,167,000
Depreciation and amortization 160,000 146,000 320,000 290,000
------------- ------------- ------------- -------------
Total expenses 2,244,000 2,377,000 4,328,000 4,964,000
------------- ------------- ------------- -------------
Loss from operations (2,176,000) (1,694,000) (4,240,000) (3,888,000)

Other income (expense)
Interest and miscellaneous income 35,000 2,334,000 68,000 2,432,000
Interest and other expense (412,000) (324,000) (732,000) (639,000)
------------- ------------- ------------- -------------
(377,000) 2,010,000 (664,000) 1,793,000
------------- ------------- ------------- -------------

Net income (loss) $(2,553,000) $ 316,000 $(4,904,000) $(2,095,000)
============= ============= ============= =============


Basic and diluted income (loss)
per common share $(0.17) $0.02 $(0.33) $(0.16)
============= ============= ============= =============

Weighted average basic and diluted
common shares outstanding 15,449,603 13,218,747 14,824,938 13,209,375
============= ============= ============= =============



BALANCE SHEET DATA
-------------------




June 30, 2004 December 31, 2003
-------------- --------------
(unaudited)

Cash and cash equivalents $ 6,148,000 $ 727,000
Short-term investments and
certificates of deposit 969,000 1,860,000
Restricted cash 589,000 649,000
Accounts receivable and inventory 1,236,000 1,257,000
Total assets 15,800,000 11,811,000
Working capital 5,753,000 1,206,000
Convertible notes and other obligations 14,112,000 14,361,000
Accumulated deficit (59,134,000) (54,227,000)
Total stockholders deficit (1,515,000) (5,825,000)



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