BDSIW Biodelivery Sciences International (MM)

BioDelivery Sciences International, Inc. Reports 2003 Results Net Loss Per Share for 2003 Was $.35, Compared to $.51 in 2002 NEWARK, N.J., April 6 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. today announced results for its fiscal year ended December 31, 2003. In 2003, BDSI had revenue of $2.9 million, compared to $828,000 in 2002. Net loss per share for 2003 was $.35, compared to $.51 in 2002. Revenue for 2003 comprised of sublicense agreements of $2 million, with the other revenues from a Small Business Innovation Research Grant (SBIR) from the National Institutes of Health, which runs through mid-year 2004. BDSI expects to receive a total of approximately $2.7 million through 2004 related to this grant. At December 31, 2003, BDSI's financial condition included cash and cash equivalents totaling approximately $2.6 million, and working capital of $2.3 million, and stockholders' equity of $3.1 million. Raphael Mannino, PhD, Executive Vice President, reported, "Our efforts in 2003 to advance our lead proprietary product, Bioral(TM) Amphotericin B are on target, and we are completing in 2004 the final year of our three-year NIH SBIR Grant. I believe this product could be the only oral antifungicidal (meaning it kills the fungus) currently available in the world marketplace, since all other oral antifungals currently in the market are fungistatic (meaning it impairs the growth of the fungus but does not kill it)." Dr. Mannino further reported, "During 2003, key milestones reached included: The demonstration in a clinical setting of our ability to use phosphatidylserine, our carrier, from soy, reducing the cost of our carrier by a factor of 60X, and we demonstrated the ability to reduce the ratio of carrier to cargo by a factor of 4X, further reducing cost and dosing size. Additionally we are engaged in a pharmaceutical evaluation agreement with a major pharmaceutical company on an approved antimicrobial. As part of our evaluation agreement with a major pet food manufacturer, we commercially scaled production of our first micronutrient formulation, and we entered into confidential evaluation agreements, principally for Bioral omega-3s with over 20 processed food and beverage companies. Also, we advanced in-house programs like the oral delivery of enzyme replacement therapy for Gaucher Disease, as well as the oral delivery of apolipoproteins for atheroma reduction, a more powerful but less toxic anti-inflammatory formulation of NSAIDs, and encochleation of siRNA, a promising new class of oligonucleotide therapeutics that needs a delivery technology to protect siRNA from premature degradation upon administration." BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology designed for a potentially broad base of pharmaceuticals, vaccines, over-the- counter drugs, nutraceuticals and micronutrients in processed foods and beverages. Additional details relating to BDSI's financial and operational results for 2003 may be found in its Annual Report on Form 10-K for 2003, filed with the Securities and Exchange Commission on March 30, 2004. Such Report is available free of charge via EDGAR at the SEC'swebsite, http://www.sec.gov/ , and at BDSI's website, http://www.bdsinternational.com/ . Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company's results to differ. Factors that may cause such differences include, but are not limited to, the Company's ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company's ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company's need for additional funding, uncertainties regarding the Company's intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results andare detailed in the company's filings with the Securities and Exchange Commission. L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remunerationfor public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company. DATASOURCE: BioDelivery Sciences International, Inc. CONTACT: Francis E. O'Donnell, Jr., M.D, President and CEO of BioDelivery Sciences International, Inc., +1-973-972-0015, or Dawn Moore of LG Zangani, LLC, +1-908-788-9660 Web site: http://www.bdsinternational.com/

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