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Washington, D.C. 20549







Pursuant to Section 13 or Section 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 9, 2012 (November 8, 2012)



BioDelivery Sciences International, Inc.

(Exact name of registrant as specified in its charter)




Delaware   001-31361   35-2089858

(State or other jurisdiction

of incorporation)



File Number)


(IRS Employer

Identification No.)

801 Corporate Center Drive, Suite #210

Raleigh, NC

(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: 919-582-9050

Not Applicable

(Former name or former address, if changed since last report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation to the registrant under any of the following provisions:


¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))




Item 8.01. Other Information.

On November 8, 2012, BioDelivery Sciences International, Inc. (the “Company”) issued a press release announcing the Company filed its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. Such announcement also provided an update on the Company’s key events, achievements and business operations in third quarter of 2012 as well as upcoming anticipated milestones for the years 2012 and 2013. A copy of such press release is attached as Exhibit 99.1 hereto.


Item 9.01. Financial Statements and Exhibits.


(d) Exhibits


99.1    Press release, dated November 8, 2012, announcing the filing of the Company’s Quarterly Report and related business operations and milestone updates.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K, the press release included herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” 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, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company’s 2012 and 2013 initiatives and potential milestones as well as peak sales estimates described in the press release which is an exhibit hereto) may differ significantly 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). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.


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.



/s/ James A. McNulty

    Name:   James A. McNulty
    Title:   Secretary, Treasurer and Chief Financial Officer