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Release issued 15th August 2002
DALLAS, TEXAS, August 15, 2002, ACCESS PHARMACEUTICALS, INC. (AMEX: AKC) today announced financial results for its second quarter ended June 30, 2002. The Company reported a net loss of $2,308,000, or $0.18 per share, for the second quarter as compared to a net loss of $1,517,000, or $0.12 per share, for the corresponding quarter in 2001. For the six-month period ended June 30, 2002 the net loss was $4,174,000, or $0.32 per share compared with a net loss of $2,688,000, or $0.21 per share for the corresponding period in 2001.
Revenue for the second quarter was $263,000 compared to $10,000 in the same period in 2001. This increase principally represents the initial licensing payment for the European marketing rights for Zindaclin®. Operating expenses increased $797,000 in the second quarter 2002, with research and development expenses accounting for $679,000 of this increase. Development costs for the polymer platinate program ($323,000), the costs associated with the pivotal OraDiscTM study ($190,000) and additional compensation expenses ($174,000) related to the organization expansion contributed to this increase. The increase in general and administrative expenses of $108,000 was due primarily to hiring of additional staff. The loss from operations in 2002 was $2,118,000 an increase of $534,000 over the prior year. An increase in net interest expense of $257,000 due to reduced cash balances and interest rates contributed to the increased net loss.
Revenue in the first six months was $379,000, an increase of $158,000 over the prior year, principally due to increased Zindaclin® licensing payments. Operating expenses increased $1,125,000 to $4,260,000, of which $999,000 was in research and development, reflecting incremental development costs ($717,000) and compensation expense ($303,000). General and administration expenses increased $171,000 to $1,070,000 as a result of increased compensation expense ($102,000) and higher franchise taxes ($70,000). Contributing to the increased net loss was an increase in net interest expense of $519,000 for the reasons outlined above.
Commenting on the results, Kerry P. Gray, President and CEO of Access stated, "Our development projects have advanced as planned according to our business plan. The increased operating expenses supported OraDisc'sTM advancement into the final pivotal study, the advancement of our clinical program for AP5280 polymer platinate and the preclinical development of AP5346, our DACH polymer platinate. Additionally, exciting progress has been made on the development of our earlier phase projects which are planned to generate the future clinical development candidates."
The Company continued to make considerable progress since the last quarterly report, which included the following:
- Licensing Agreement with Fujisawa, a major dermatology company, to market Zindaclin® in continental Europe.
- Acquiring the amlexanox patent and trademarks.
- Successfully advancing Zindaclin® through the regulatory process in Europe.
- Advancing OraDiscTM into the final pivotal study for the treatment of canker sores.
- Completing the AP5280 polymer platinate Phase I study and presenting preliminary results at ASCO.
Mr. Gray added, "Recent events have placed the company in a strong position to immediately increase revenues. With the licensing of Zindaclin® to Fujisawa and the advancement of registration in Europe, quarterly revenues from this product will continue to increase. Also, now that Access owns the worldwide rights to amlexanox for the prevention and treatment of canker sores, a continuous revenue stream from this product will materialize. This places the company in a sound position from which to accelerate revenue growth and product development activities."
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®, 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®, which utilizes ResiDerm®, Access' 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 the uncertainties associated with research and development activities, clinical trials, the integration of acquired companies and technologies, the timing of regulatory approvals, dependence on others, collaborations, future cash flow, the timing and receipt of licensing revenues, the future success of the Company's marketed products Aphthasol® and Zindaclin® and products in development including polymer platinate, OraDiscTM and the Mucositis technology and other risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2001, and other reports filed by us with the Securities and Exchange Commission.
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(14th January 2003) ACCESS PHARMACEUTICALS, INC. TO CONDUCT CONFERENCE CALL - Company To Discuss Today's Announcements
(14th January 2003) ACCESS PHARMACEUTICALS, INC. SIGNS AMLEXANOX LICENSING AGREEMENT WITH ZAMBON GROUP
(19th December 2002) ACCESS PHARMACEUTICALS, INC., ANNOUNCES ZINDACLIN® RECEIVES APPROVAL IN EIGHT ADDITIONAL EUROPEAN MARKETS - Additional License Agreements Executed
(11th December 2002) ACCESS PHARMACEUTICALS, INC. ANNOUNCES BOARD APPOINTMENT