BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Files An 8-K Completion of Acquisition or Disposition of Assets
Item 2.01 of Form 8-K. Therefore, and the Company hereby amends
the Original Report and the Second Report accordingly.
In addition, the Company, following discussions between the
Company and the staff of U.S. Securities and Exchange Commission
(the SEC), plans to file, via an amendment to the Second Report,
certain abbreviated audited financial statement and pro forma
financial information related to the Assets under Items 9.01(a)
and 9.01(b) of Form 8-K as required by the rules and regulations
of the SEC, such audited statements and information to be filed
when available.
The remainder of the Original Report and the Second Report
(including the exhibits thereto) remain unchanged.
| Item2.01. |
Completion of Acquisition or Disposition of Assets. |
On January9, 2017, BioDelivery Sciences International, Inc. (the
Company) consummated the transactions contemplated by that
certain Termination Agreement, dated December7, 2016 (the
Termination Agreement), by and between the Company, its
wholly-owned subsidiaries, Arius Pharmaceuticals Inc. and Arius
Two Inc., and Endo Pharmaceuticals, Inc. (Endo). The Termination
Agreement terminated Endos licensing rights for the Companys
product BELBUCA (buprenorphine) buccal film (CIII) (BELBUCA).
At the closing of the transactions contemplated by the
Termination Agreement (the Closing), the Company purchased from
Endo the following assets (the Assets): (i) current BELBUCA
product inventory and work-in-progress, (ii)material
manufacturing contracts related to BELBUCA, (iii)BELBUCA-related
domain names and trademarks (including the BELBUCA trademark),
(iv) BELBUCA-related manufacturing equipment, and (v)all
pre-approval regulatory submissions, including any
Investigational New Drug Applications and New Drug Applications,
regulatory approvals and post-approval regulatory submissions
concerning BELBUCA. The purchase price for the Assets (the Asset
Purchase Price) was equal to the sum of: (i)the aggregate book
value of the portion of the transferred product inventory
forecasted to be used or sold by the Company, (ii)the aggregate
book value of work-in-progress inventory, and (iii)the assumption
of any assumed liabilities. Upon Closing, the Company accepted
transfer of the Assets and assumed and agreed to discharge when
due all applicable liabilities assumed by the Company, which
consisted of post-Closing obligations for liabilities and
payments associated with the Assets, the assumed contracts
related to the Assets and applicable taxes (with the obligation
for pre-Closing and other certain liabilities resulting from the
acts or omissions of Endo being retained by Endo).
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The Asset Purchase
Price, together with all other payments (including a non-compete covenant payment)
due to Endo under the Termination Agreement, will be paid to Endo
in four quarterly installments on the last calendar day of each
quarter in 2017. Furthermore, the Company will not be responsible
for future royalties or milestone payments to Endo, and Endo will
not be obligated to any future milestone payments to the Company.
The Termination Agreement contains customary representations and
warranties and mutual releases and indemnification.
At the Closing, the Company
and Endo entered into a Transition Services Agreement which will
govern the post-Closing rights and responsibilities of the
Company and Endo in connection with the license termination and
the transfer of the Assets to the Company. Under this agreement,
the Company and Endo agreed to the handling of transition matters
such as managing customer contracts, BELBUCA price reporting,
payments, returns and rebates, and customer and managed care
relations. In connection therewith, Endo agreed to provide to the
Company an agreed upon number of work hours to be provided by
Endo personnel during the transition for certain of these
transition services and other assistance with respect to the
transition of BELBUCA to the Company.
The Company has determined
that the acquisition of the Assets should be treated as the
acquisition of a business for financial accounting purposes.
Therefore, the Company plans to file, via an amendment to this
Report, certain abbreviated audited financial statement and pro
forma financial information related to the Assets under Items
9.01(a) and 9.01(b) of Form 8-K as required by the rules
and regulations of the U.S. Securities and Exchange Commission
when such audited statements and information are
available.
| Item9.01. | Financial Statements and Exhibits. |
| (a) | Financial statements of businesses acquired. |
To be provided by amendment to
the Second Report.
| (b) | Pro forma financial information. |
To be provided by amendment to
the Second Report.
Cautionary Note
Regarding Forward-Looking
Statements
This Current Report on Form
8-K/A 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 Companys 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 Companys management
and are subject to significant risks and uncertainties, including
those detailed in the Companys filings with the Securities and
Exchange Commission. Actual results (including, without
limitation, the results of the Companys reacquisition of, and
commercialization efforts for BELBUCA as described therein) 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 Companys 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.
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About BioDelivery Sciences International, Inc. (NASDAQ:BDSI)
BioDelivery Sciences International, Inc. is a specialty pharmaceutical company. The Company develops and commercializes, either on its own or in partnerships with third parties, applications of approved therapeutics to address unmet medical needs using drug delivery technologies. The Company develops pharmaceutical products aimed principally in the areas of pain management and addiction. The Company’s products utilize the BioErodible MucoAdhesive (BEMA) drug delivery technology, a small, erodible polymer film for application to the buccal mucosa (the lining inside the cheek). The Company’s United Sates Food and Drug Administration (FDA) approved product, ONSOLIS (fentanyl buccal soluble film), as well as its approved products BUNAVAIL (buprenorphine and naloxone buccal film) buccal film and BELBUCA (buprenorphine) buccal film, utilize BEMA technology. BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Recent Trading Information
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) closed its last trading session down -0.17 at 1.75 with 344,458 shares trading hands.