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) November 19, 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)
Item 5. Other Events and Regulation FD Disclosure.
On November 19, 2003, BioDelivery Sciences International, Inc. (the "Company")
announced that it is intending to distribute to its stockholders 3,545,431 Class
B Memberships Shares (the "Class B Shares"), or approximately 47% of the
currently outstanding interests, of its subsidiary, Bioral Nutrient Delivery,
LLC ("BND"). The Company previously announced that it would distribute rights to
its stockholders to purchase up to 11,277,000 of such interests from the
Company, both initially at $0.01 per interest and then quarterly over of 3 year
period at the then fair market value. The Company has decided to change the
structure and distribute only 3,545,431 Class B Shares directly to Company
stockholders of record on a pro-rata, one-time basis. Subject to compliance with
applicable laws and the facts and circumstances at such time, the Company may
elect to distribute additional Class B Shares in the future, although no
assurances can be given that any such additional distributions will ever be
undertaken. In February 2003, BND filed a registration statement on Form SB-1
with the Securities and Exchange Commission to register the rights and the
underlying Class B Shares. Given the change in structure, such registration
statement was withdrawn on November 18, 2003. Instead, on November 19, 2003, BND
filed a registration statement on Form 10-SB covering the proposed, one-time
distribution of 3,545,431 Class B Shares by the Company to its stockholders.
Company stockholders will not be required to purchase Class B Shares in
connection with the distribution.
In addition, the Company announced that it has amended its April 1, 2003 license
agreement with BND to included personal care products. The original license gave
BND rights to BioDelivery's licensed nano-encochleation delivery technology to
develop ways to deliver nutrients for non-pharmaceutical use in the processed
food and beverage industries for both human and animal consumption. As amended,
the license gives BND the right to exploit such technology in the personal care
products sector as well. In addition, the Company announced that it has amended
its March 31, 2003 management agreement with BND, pursuant to which the Company
provides management and administrative services to BND at no cost, to extend the
initial term of such agreement from Mach 31, 2004 to December 31, 2004.
The distribution of Class B Shares in BND will commence when the Form 10-SB
becomes effective pursuant to SEC rules, which is anticipated to be 60 days from
the date of filing. Following the distribution, BSDI stockholders will own
approximately 47% of the currently outstanding economic interests in BND, and
BND will be a separate reporting company with the SEC. However, such percentage
will be subject to dilution based on a number of factors, including the
possibility of new equity ownership interests being issued as BND pursues its
licensing opportunities. Furthermore, the interests in BND will not, nor is it
anticipated that they will be, publicly-traded and holders of such interests
will be severely limited in their rights to transfer such interests. More
information about the distribution, the Class B Shares and BND generally can be
found in the registration statement on Form 10-SB filed by BND with the SEC,
including the information statement attached thereto as an exhibit.
Item 7. Financial Statements and Exhibits.
Set forth below is a list of Exhibits included as part of this Current Report.
10.1 Amended and Restated Limited Liability Company Operating Agreement of
Bioral Nutrient Delivery, LLC, dated October 1, 2003, by the Company,
as Managing Member.
10.2 First Amendment to Sub-License Agreement, dated effective April 1,
2003, by and between the Company and Bioral Nutrient Delivery, LLC.
10.3 First Amendment to Management Services and Administrative Agreement,
dated effective April 1, 2003, by and between BioDelivery Sciences
International, Inc. and Bioral Nutrient Delivery, LLC
10.4 Evaluation Agreement and Option to License, dated September 5, 2002 by
and between BioDelivery Sciences International, Inc. and *****
(confidential treatment requested for certain portions of this exhibit
pursuant to 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2)
99.1 Press Release of the Company, dated November 19, 2003, relating to
the distribution of Class B Shares of BND.
This Current Report on Form 8-K may contain, among other things, certain
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, including, without limitation, (i) statements
about the benefits of the distribution of the Rights and the Additional Rights;
(ii) statements with respect to the Company's plans, objectives, expectations
and intentions with respect to BND; and (iii) other statements identified by
words such as "may", "could", "would", "should", "believes", "expects",
"anticipates", "estimates", "intends", "plans" or similar expressions. These
statements are based upon the current beliefs and expectations of the Company's
management and are subject to significant risks and uncertainties. Actual
results may differ from those set forth in the forward-looking statements. These
forward-looking statements involve certain risks and uncertainties that are
subject to change based on various factors (many of which are beyond the
Company's control).
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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.
November 19, 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