BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Files An 8-K Financial Statements and Exhibits
Item9.01 Financial Statements and Exhibits.
| (a) |
Financial Statement of Businesses Acquired. |
The Company has been advised by Endo that it was impracticable to
prepare complete financial statements related to the BELBUCA
product line as required by Rule 3-05 of Regulation S-X.In this
regard, the Company has been advised by Endo that the BELBUCA
product line was not a separate legal entity of Endo and was
never operated as a stand-alone business, division or subsidiary.
Endo has also advised the Company that it has never prepared full
stand-alone or full carve-out financial statements for the
BELBUCA product line, and that Endo has never maintained the
distinct and separate accounts necessary to prepare such
financial statements. As a result, the Company is filing the
following BELBUCA Financial Statements related to the product
line for the purpose of complying with the requirements of Rule
3-05 of Regulation S-X:
|
The audited statement of net assets acquired of the BELBUCA product line as of January6, 2017 and the notes related thereto, which is filed as Exhibit 99.1 to this Current Report on Form 8-K/A2 and is hereby incorporated herein by reference. |
|
The audited statement of revenues and direct expenses of the BELBUCA product line for the year endedDecember 31, 2016 and the notes related thereto, which is filed as Exhibit 99.2 to this Current Report on Form 8-K/A2 and is incorporated herein by reference. |
to a letter, dated March15, 2017, from the staff of the Division
of Corporation Finance (the Division) of the SEC to the Company,
the Division stated that it will not object to the Companys
conclusion that the filing of the above identified financial
statements represents substantial compliance with the
requirements of Rule 3-05 of Regulation S-X.
| (b) | Pro Forma Financial Information. |
The unaudited pro forma condensed combined statement of
operations for the year ended December31, 2016, and the notes
related thereto, reflecting the Companys acquisition of the
BELBUCA product line, are filed as Exhibit 99.3 to this Current
Report on Form 8-K/A2 and are incorporated herein by reference.
| (d) | Exhibits |
|
ExhibitNo. |
Description |
|
| 23.1 |
Consent of Cherry Bekaert LLP, Independent Registered Public Accounting Firm. |
|
| 23.2 | Consent of PricewaterhouseCoopers LLP, Independent Auditor. | |
| 99.1 |
Statement of Net Assets Acquired (audited) of the BELBUCA product line as of January6, 2017 and the notes related thereto. |
|
| 99.2 |
Statement of Revenues and Direct Expenses (audited) of the BELBUCA product line for the year ended December31, 2016 and the notes related thereto. |
|
| 99.3 |
Unaudited pro forma condensed combined statement of operations for the year ended December31, 2016, and the notes related thereto. |
Cautionary Note Regarding Forward-Looking
Statements
This Current Report on Form8-K/Aand 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.
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 up +0.10 at 2.30 with 546,519 shares trading hands.