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): June 21, 2017
BioDelivery Sciences International, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-31361 | 35-2089858 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 4131 ParkLake Ave., Suite #225 | ||
| Raleigh, NC | 27612 | |
| (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)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 8.01. | Other Information. |
On June 21, 2017, BioDelivery Sciences International, Inc. (the “Company”) issued a press release announcing that it has executed an agreement with CVS/Caremark extending access to two of the Company’s products, BELBUCA® (buprenorphine) buccal film (CIII) and BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII), through 2020. A copy of the press release is attached as Exhibit 99.1 hereto.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| 99.1 | Press release, dated June 21, 2017, announcing the Company’s contract with CVS/Caremark. |
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 actual impact on the Company’s sales as a result of the managed care contract described in the attached press release) 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.
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.
| June 21, 2017 | BIODELIVERY SCIENCES INTERNATIONAL, INC. | |||||||||
| By: | /s/ Ernest R. De Paolantonio | |||||||||
| Name: | Ernest R. De Paolantonio | |||||||||
| Title: | Chief Financial Officer, Treasurer and Secretary | |||||||||
Exhibit 99.1
BioDelivery Sciences Announces Agreement with CVS/Caremark for
BELBUCA® and BUNAVAIL® Through 2020
RALEIGH, NC – June 21, 2017 – BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has signed an agreement with CVS/Caremark extending access to both BELBUCA® (buprenorphine) buccal film (CIII) and BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) through 2020. The agreement is important as CVS/Caremark represents a significant portion of the covered lives in the United States.
BDSI reacquired BELBUCA from Endo Pharmaceuticals in January 2017 and subsequently relaunched the product. Prescription sales for BELBUCA reached their highest point in May 2017 since the product was launched by Endo in early 2016 and continues to grow in June. Weekly sales for BELBUCA for the week ending June 9, 2017 (1,657 prescriptions) exceeded the previous peak from December 2016 for the first time according to data from Symphony Health.
“We are pleased with the momentum we are beginning to see with BELBUCA as well as the execution of new managed care contracts, such as the CVS/Caremark agreement which goes through 2020,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. “We have seen an overall increase in BELBUCA sales since relaunching the product, and for the first time, we recently exceeded both monthly and weekly sales levels achieved by Endo, suggesting that our current strategy, although early in the process, appears to be working as planned. Furthermore, we believe the continued focus on responsible use of opioids and actions taken by FDA in this regard bode well for BELBUCA’s growth prospects.”
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine. BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.
BDSI’s development strategy focuses on the utilization of the FDA’s 505(b)(2) approval process. This regulatory pathway creates the potential for more timely and efficient approval of new formulations of previously approved therapeutics.
BDSI’s area of focus is the development and commercialization of products in the areas of pain management and addiction. These are areas where BDSI believes its drug delivery technologies and products can best be applied to address critical unmet medical needs. BDSI’s marketed products and those in development address serious and debilitating conditions such as breakthrough cancer pain, chronic pain, painful diabetic neuropathy and opioid dependence. BDSI’s headquarters is in Raleigh, North Carolina.
For more information, please visit or follow us:
Internet: www.bdsi.com
Facebook: Facebook.com/BioDeliverySI
Twitter: @BioDeliverySI
BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) and BELBUCA® (buprenorphine) buccal film (CIII) are marketed in the U.S. by BioDelivery Sciences. ONSOLIS® (fentanyl buccal soluble film) (CII) is licensed in the U.S. to Collegium Pharmaceutical pursuant to the U.S. licensing and development agreement between BDSI and Collegium. For full prescribing information and important safety information on BDSI products, including BOXED WARNINGS for ONSOLIS, please visit www.bdsi.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at (800) 469-0261. For full prescribing and safety information on BELBUCA, please visit www.belbuca.com and for full prescribing and safety information on BUNAVAIL, please visit www.bunavail.com.
Cautionary Note on Forward-Looking Statements
This press release any statements of employees, 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 actual impact on the Company’s sales as a result of the managed care contract described herein) 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 presentations or otherwise, except as required by applicable law.
BDSI®, BEMA®, ONSOLIS®, BUNAVAIL® and BELBUCA® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences, BUNAVAIL and BELBUCA logos are trademarks owned by BioDelivery Sciences International, Inc. All other trademarks and tradenames are owned by their respective owners.
© 2017 BioDelivery Sciences International, Inc. All rights reserved.
Contacts
Investors:
Matthew P. Duffy
Managing Director
LifeSci Advisors, LLC
212-915-0685
matthew@lifesciadvisors.com
Al Medwar
Senior Vice President, Corporate and Business Development
BioDelivery Sciences International, Inc.
919-582-9050
amedwar@bdsi.com
Media:
Susan Forman/Laura Radocaj
Dian Griesel Int’l.
212-825-3210
sforman@dgicomm.com
lradocaj@dgicomm.com