UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) March 28, 2003
BioDelivery Sciences International, Inc.
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(Exact name of registrant as specified in its charter)
Delaware 0-28931 35-2089858
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(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
UMDNJ Medical School
185 South Orange Avenue, Bldg #4
Newark, New Jersey 07103
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (973) 972-0015
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Not Applicable
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(Former name or former address, if changed since last report)
Items 9 and 12. Other Events and Regulation FD Disclosure; Results of Operation
and Financial Condition.
On March 28, 2003, BioDelivery Sciences International, Inc., a Delaware
corporation (the "Company"), filed its Annual Report on Form 10-KSB (the
"10-KSB") with the Securities and Exchange Commission. On April 1, 2003, the
Company issued a press release summarizing its financial and operational results
for its fiscal year ended December 31, 2002.
In footnote 2 to the financial statements appearing in the 10-KSB, the Company
disclosed that it entered into a licensing agreement with a company (which is a
shareholder), which license included an up-front non-refundable payment of $2
million, which was received in January 2003. The Company has deferred the
revenue and will recognize it over the period of the related research and
development commitment. The agreement also provides for milestone payments. This
license agreement was previously disclosed via a Current Report on Form 8-K,
dated January 7, 2003, at which time the Company requested confidential
treatment with respect to, among other matters, such $2 million payment.
Notwithstanding such confidential treatment request, the Company has disclosed
such payment as part of its 10-KSB and this Current Report.
Item 7. Financial Statements and Exhibits.
Set forth below is a list of Exhibits included as part of this Current Report.
99.1 Press Release of the Company, dated March 31, 2003, summarizing its
financial and operational results for its fiscal year ended December 31,
2002.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
April 1, 2003 BIODELIVERY SCIENCES INTERNATIONAL, INC.
By: /s/ Francis E. O'Donnell, Jr.
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Name: Francis E. O'Donnell, Jr.
Title: President and Chief Executive Officer
EXHIBIT 99.1
BioDelivery Sciences Int., Inc. L. G. ZANGANI, LLC
NASDAQ: BDSI Nine Main Street, Flemington, NJ 08822
(908) 788-9660 Fax: (908) 788-4024
E-mail: office@zangani.com
Web site: http://www.zangani.com
For Release: IMMEDIATELY
Contact: Francis E. O'Donnell, Jr., M.D Susan Bonitz, Ph.D. Kevin Nally
President and CEO LG Zangani, LLC L.G. Zangani, LLC
973-972-0015 908-788-9660 908-788-9660
NEWS RELEASE
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BioDelivery Sciences International, Inc.
Reports 2002 Results
Net loss per share for 2002 was $.51, compared to $1.15 in 2001.
Newark, New Jersey, April 1, 2003 - BioDelivery Sciences International, Inc.
(NASDAQ:BDSI; BDSIW) today announced results for its fiscal year ended December
31, 2002.
In 2002, BDSI had sponsored research revenue of $828,000, compared to $478,000
in 2001. Virtually all revenue in both years was from a Small Business
Innovation Research Grant from the National Institutes of Health.
In June, 2002, BDSI completed its initial public offering, resulting in
approximately $8.6 million, net of offering costs of approximately $2.4 million.
At December 31, 2002, BDSI's financial condition includes cash and cash
equivalents totaling approximately $5.2 million, compared to approximately
$76,000 at December 31, 2001. In addition, the Company had a receivable of $2
million from a sublicense agreement, which sublicense agreement the Company
announced on January 7, 2003 and which was collected in January 2003.
James A. McNulty, BDSI's Chief Financial Officer, reported, "Our efforts in 2002
to advance our lead proprietary product, Bioral(TM) Amphotericin B are on
target, with almost two years completed of the three-year NIH Grant. Our initial
public offering was successful and our financial structure will finance our
expected costs through 2004. Staffing at our Newark, New Jersey laboratory is in
place. We are finalizing some laboratory improvements and needed scientific
equipment purchases, with financing commitments currently in place, which
improvements we expect to be finished by mid-2003. We will continue to manage
costs and available resources as we pursue outlicensing of our delivery
nanotechnology for applications in pharmaceuticals, vaccines, gene therapy, OTC
drugs, nutraceuticals, supplements and, through our Bioral Nutrient Delivery,
LLC subsidiary, processed food and beverages."
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 2002
may be found in its Annual Report on Form 10-K for 2002, filed with the
Securities and Exchange Commission on March 28, 2003. Such Report is available
free of charge via EDGAR at the SEC's website, www.sec.gov. and at BDSI's
website, www.bdsinternational.com. -----------
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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 and are 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
remuneration for 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.