Regulation FD Disclosure (Form 8-K)

Regulation FD Disclosure

On September 21, 2021, BioDelivery Sciences International, Inc. ("the Company") filed under seal a Motion for Order to Show Cause why Defendants Should not be Held in Contempt for Violating the Court Order of June 28, 2021 (the "Motion").On June 28, 2021, citing the statute authorizing the Court to extend the 30-month stay under the Hatch-Waxman Act, the Court ordered Alvogen (as defined below) not to "launch" its generic product until it could reach a final decision on the merits in the case. In the Motion, the Company contends that Alvogen PB Research & Development LLC, Alvogen Malta Operations Ltd., Alvogen Pine Brook LLC, Alvogen, Inc. and Alvogen Group, Inc. (together, "Alvogen") violated the order of the United States District Court for the District of Delaware commencing in or about August 2021 by, among other things, offering the generic product for sale through five compendia / price reporting services, including First Databank, Medi-Span (Wolters Kluwer), Red Book, Gold Standard and ScriptPro.As alleged in the Motion, after Alvogen's product launch, certain payers began declining insurance coverage for the Company's brand BELBUCA and directing use of Alvogen's generic substitute and/or made it more difficult for patients to obtain insurance coverage for BELBUCA, and thereby damaged the Company.In addition to filing the Motion, the Company demanded that Alvogen withdraw its compendia listings. Alvogen claims to have withdrawn its compendia product listings on or about September 9, 2021.

While the Company continues to evaluate the longer term impact on its business of Alvogen's conduct, as alleged in the Motion, the Company currently believes that net revenues for the quarter ended September 30, 2021 will be in a range of $38 million to $42 million.The Company remains confident in the validity of its Orange Book patents listed for BELBUCA and will continue to vigorously defend its patent rights.

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