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News Release

BioDelivery Sciences Provides Corporate Update and Reports Third Quarter 2016 Financial Results

November 9, 2016 at 12:00 AM EST

Six BUNAVAIL® Managed Care Agreements Secured Since July; Additional Access to BUNAVAIL Provides Potential for Strong First Half 2017 Growth

Department of Health and Human Services Increases Patient Cap; Potential for Significant Increase in Patients Entering Treatment for Opioid Dependence

BDSI Meets Third Quarter Objective of Providing Stability to BUNAVAIL Prescription Sales Following Second Quarter Commercial Consolidation

BUNAVAIL Prescription Sales Up 68% Compared to Third Quarter 2015

Top-Line Phase 2b Data for Clonidine Topical Gel Expected in December

Buprenorphine 30-Day Injection IND Submission Expected by Year-End

 

RALEIGH, N.C., Nov. 9, 2016 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) today reported financial results for the third quarter ended September 30, 2016, and provided an update on recent business highlights and upcoming milestones.

BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) net revenue for the three months ended September 30, 2016, was $2.0 million compared to $2.1 in the prior quarter and $1.2 million in the third quarter of 2015.  BDSI believes that its goal of stabilizing BUNAVAIL revenue following the sales and marketing consolidation that was implemented in May 2016 is being achieved.  As BDSI heads towards the first quarter of 2017, growth is now anticipated behind this consolidated commercial effort and will be driven by the six new managed care contracts recently secured.

Net revenue per BUNAVAIL prescription was relatively unchanged in the third quarter as compared to the second quarter of 2016.  Cost of goods sold (COGS) decreased by 4% in the third quarter versus the second quarter of 2016 and is expected to improve an additional 30% by the end of 2017.

BDSI's total net revenue for the three-months ended September 30, 2016 was $3.6 millioncompared to $1.2 million for the same period last year and $5.0 million for the quarter ended June 30, 2016.  The latter included a one-time recording of $2.5 million for the upfront payment from Collegium Pharmaceutical for the licensing rights to ONSOLIS® in the U.S.

Managed care contracts remain central to the future growth of BUNAVAIL and significant progress was achieved in the third quarter of this year.  BDSI has secured six contracts since July that will provide BUNAVAIL potential increased access to approximately half a million prescriptions annually for buprenorphine products for opioid dependence.  Four of the contracts provide access along with only one other branded buprenorphine/naloxone product and two of these contracts add BUNAVAIL alongside both branded products.  While some contracts go into effect during the fourth quarter, three have an implementation date of January 1, 2017, including the managed care plan where Suboxone film will become non-preferred.

On August 8, 2016, the Department of Health and Human Services' (HHS) rule change increasing the number of patients an individual physician can treat with buprenorphine from 100 to 275 patients went into effect.  According to the Substance Abuse and Mental Health Services Administration (SAMHSA) in September, 1,665 clinicians applied for and were granted waivers to prescribe buprenorphine for the treatment of opioid dependence at the increased limit of 275.  HHS had estimated that between 500 and 1,800 practitioners would request approval to treat up to 275 patients within the first year, resulting in an estimated range of 10,000 to 90,000 additional patients.  This could result in BUNAVAIL having access to over half a million additional new prescriptions. 

"We continue to achieve meaningful progress throughout our business, most importantly with managed care contracting for BUNAVAIL," said Dr. Mark A. Sirgo, President and Chief Executive Officer.  "During the third quarter, we achieved our goal of stabilizing the BUNAVAIL business behind the lowered cost structure that we implemented in the second quarter.  Our focus now is on bringing BUNAVAIL to profitability by the end of 2017.  We will achieve this objective by focusing first on increasing BUNAVAIL top-line sales, which will be driven by improved managed care access and formulary position and new patients entering treatment following the recent patient cap increase.  These two factors alone have the potential to provide us with access to nearly 1 million new prescriptions over the next year that we did not have access to previously.  Second, we will continue improving the bottom-line both through our reduced commercial expenses and an improved profit margin by reducing our COGS and improving our gross to net for BUNAVAIL."

"Looking at the remainder of our portfolio, our commercialization partner, Endo Pharmaceuticals, continues to progress with the launch of BELBUCA® while making important progress with commercial payers.  In addition, last week, BELBUCA reached its highest prescription volume since launch, as sales continue to demonstrate the potential for growth, despite the current challenges around the use of opioids to treat pain," continued Dr. Sirgo.  "In addition, we continue to expect the availability of top-line data for our Phase 2b study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy in December.  Finally, in regards to our 30-day buprenorphine injection, we are working diligently toward the submission of our IND before year-end.  Overall, we remain enthusiastic around the opportunities with both our marketed and pipeline products over the remainder of 2016 and into 2017."

FINANCIAL HIGHLIGHTS

Third Quarter Ended September 30, 2016 Financial Results Overview

  • Net revenue for the third quarter ended September 30, 2016, was $3.6 million, comprised primarily of $2.0 million of BUNAVAIL revenue, compared to $1.2 million in the same period of 2015.
  • Total operating expenses for the third quarter ended September 30, 2016, were $16.5 million, compared to $19.2 million in the third quarter of 2015.
  • Net loss for the third quarter ended September 30, 2016, was $16.0 million, or ($0.30) per diluted share, compared to a net loss of $20.4 million, or ($0.39) per diluted share in the same period of 2015.

Nine Months Ended September 30, 2016 Financial Results Overview

  • Total revenue for the nine months ended September 30, 2016, was $11.6 million, compared to $16.0 million in the same period of 2015.
  • Total operating expenses for the nine months ended September 30, 2016, were $51.4 million, compared to $56.7 million in the same period of 2015.
  • Net loss for the nine months ended September 30, 2016, was $51.2 million, or ($0.96) per diluted share, compared to a net loss of $47.8 million, or ($0.92) per diluted share, in the same period of 2015.
  • BDSI had cash and cash equivalents of approximately $44.7 million at September 30, 2016.

CORPORATE UPDATE AND RECENT ACCOMPLISHMENTS

BUNAVAIL (buprenorphine and naloxone) buccal film (CIII)

  • BUNAVAIL prescription sales in the third quarter increased slightly from the second quarter of 2016, with an increase of 68% over the same period last year.
  • Third quarter marked the first full quarter since BDSI completed a comprehensive salesforce restructuring.
    • Current sales force now covers 85% of the overall market.
    • Changes are expected to reduce commercial expenses by approximately $20 millionthrough the end of 2017.
  • Secured six new managed care wins since July.
    • Contracts will provide BUNAVAIL potential access to an additional 500,000 prescriptions annually for buprenorphine products for opioid dependence, according to data from Symphony Health.
    • Four of the contracts provide access along with only one other branded buprenorphine/naloxone product, and in one plan, Suboxone film will move to non-preferred status in January. The other two contracts add BUNAVAIL alongside both branded products.
    • While two contracts go into effect during the fourth quarter, three have an implementation date of January 1, 2017.

BELBUCA (buprenorphine) buccal film (CIII)

  • The third quarter represented BDSI's first quarter of recognizing royalty revenue paid by Endo from sales of BELBUCA.
  • Last week, BELBUCA prescription sales reached its highest point since launch, according to data from Symphony Health, as sales continue to demonstrate the potential for growth despite the current challenges in the opioid market.

Clonidine Topical Gel – Painful Diabetic Neuropathy

  • Phase 2b clinical study completed enrollment and randomization ahead of schedule.
  • Top-line data expected to be available in December.

Buprenorphine 30-Day Injection – Pain & Opioid Dependence

  • Currently expect to submit an Investigational New Drug Application (IND) before year-end.
  • Continued activities to support initiation of the first-in-man study, which BDSI expects to begin during the first quarter of 2017.

Appointed Timothy C. Tyson to Board of Directors

  • Appointed as an independent director.
  • Corporate career spans over 30 years in the pharmaceutical industry, including leadership positions at GlaxoSmithKline, Valeant Pharmaceuticals and Bristol-Myers.
  • Currently Chairman and CEO of Avara Pharmaceutical Services and Chairman at Icagen Inc., and recently served as Chairman and CEO of Aptuit LLC.

KEY ANTICIPATED LATE 2016 – EARLY 2017 MILESTONES

  • Implementation of recently awarded BUNAVAIL managed care contracts.
  • Continued BELBUCA prescription growth.
  • Clonidine Topical Gel Phase 2b study preliminary results in December.
  • IND filing of Buprenorphine 30-day injection for the treatment of opioid dependence by end of year, followed by initiation of a single-dose pharmacokinetic study.

CONFERENCE CALL AND WEBCAST

Wednesday, November 9th @ 8am Eastern Time

Domestic:           

888-778-9064

International:      

913-312-0417

Conference ID:     

6212819

Webcast:               

http://public.viavid.com/index.php?id=121503

Replay, available through November 23rd:

Toll-Free:            

844-512-2921

International:       

412-317-6671

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) is marketed in the U.S. by BioDelivery Sciences.  BELBUCA™ (buprenorphine) buccal film (CIII) is commercialized in the U.S. by Endo Pharmaceuticals pursuant to the worldwide licensing and development agreement between BDSI and Endo.  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.

Cautionary Note on Forward-Looking Statements

This press release, the conference call described herein, and 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 results of commercialization efforts for the Company's approved products and the clinical trials for, and regulatory review of, the Company's products in development) 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® and BUNAVAIL® are registered trademarks of BioDelivery Sciences International, Inc.  The BioDelivery Sciences and BUNAVAIL logos are trademarks owned by BioDelivery Sciences International, Inc.  BELBUCA® is a trademark owned by Endo Pharmaceuticals.  All other trademarks and tradenames are owned by their respective owners.

© 2016 BioDelivery Sciences International, Inc.  All rights reserved.

 

 

 

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BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES 

CONDENSED CONSOLIDATED BALANCE SHEETS 

(U.S. dollars, in thousands, except share and per share amounts) 

(Unaudited) 

     
 

September 30,

December 31,

ASSETS

2016

2015

     

Current assets:

   

Cash and cash equivalents

44,682

83,560

Accounts receivable

3,089

2,488

Inventory

4,018

2,558

Prepaid expenses and other current assets

4,470

3,933

 

56,259

92,539

     
     

Property and equipment, net

4,253

4,262

Goodwill

2,715

2,715

Other intangible assets, net

2,528

3,256

     

Total assets

$                   65,755

$                102,772

     

LIABILITIES AND STOCKHOLDERS' EQUITY

   

Current liabilities:

   

Accounts payable and accrued liabilities, other

18,839

19,501

Notes Payable, current

11,446

6,707

Deferred revenue, current

1,922

1,875

Derivative liability

100

-

Total current liabilities

32,307

28,083

     

Notes payable, less current maturities

17,726

22,168

Deferred revenue, long term

20,000

20,000

Other Long Term liabilities

825

825

     

Total liabilities

70,858

71,076

     

Commitments and contingencies (Notes 7 and 12)

-

-

     

Stockholders' (deficit) equity:

   

Preferred Stock, $.001 par value; 5,000,000 shares authorized; 2,093,155 
shares of Series A Non-Voting Convertible Preferred Stock outstanding at 
September 30, 2016 and December 31, 2015

2

2

Common Stock, $.001 par value; 75,000,000 shares authorized; 54,133,511 
and 52,730,799 shares issued; 54,118,020 and 52,715,308 shares outstanding 
at September 30, 2016 and December 31, 2015, respectively

54

53

Additional paid-in capital

289,287

274,891

Treasury stock, at cost, 15,491 shares

(47)

(47)

Accumulated deficit

(294,399)

(243,203)

     

Total stockholders' (deficit) equity

(5,103)

31,696

     

Total liabilities and stockholders' (deficit) equity

$                   65,755

$                102,772

 

 

 

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BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 

(U.S. dollars, in thousands, except share and per share amounts) 

(Unaudited) 

           
 

Three Months Ended September 
30,

 

Nine Months Ended September 
30,

 

2016

2015

 

2016

2015

Product sales

$                 2,009

$                1,155

 

$                  6,221

$           2,665

Product royalty revenues

1,065

25

 

2,393

689

Research and development reimbursements

497

55

 

501

909

Contract revenues

-

-

 

2,500

11,759

           

Total Revenues

3,571

1,235

 

11,615

16,022

           

Cost of sales

2,314

1,699

 

8,958

5,443

           

Expenses:

         
           

Research and development:

4,402

4,473

 

13,786

15,527

Selling, general and administrative

12,054

14,715

 

37,606

41,185

           

Total expenses

16,456

19,188

 

51,392

56,712

           

Loss from operations

(15,199)

(19,652)

 

(48,735)

(46,133)

           

Interest expense, net

(786)

(785)

 

(2,477)

(1,732)

Derivative gain

14

-

 

36

-

Other (expense) income, net

(6)

(2)

 

(20)

21

           

Net loss

$             (15,977)

$            (20,439)

 

$               (51,196)

$        (47,844)

           

Basic and diluted loss per share:

$                 (0.30)

$                (0.39)

 

$                   (0.96)

$            (0.92)

           

Weighted average common stock shares outstanding, 
basic and diluted:

53,767,099

52,542,715

 

53,531,770

52,286,757

 

 

 

   

BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES 

   

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 

   

(U.S. dollars, in thousands) 

   

(Unaudited) 

         
     

Nine months ended 
September 30,

     

2016

2015

Operating activities:

   
 

Net loss

$           (51,196)

$      (47,844)

   

Depreciation 

325

248

   

Accretion of discount

297

400

   

Amortization of Intangible Assets

728

728

   

Derivative liability

100

-

   

Stock-based compensation expense

11,600

12,703

 

Changes in assets and liabilities:

   
   

Accounts receivable

(601)

1,734

   

Inventories

(1,460)

(59)

   

Prepaid expenses and other assets

(537)

(727)

   

Accounts payable and accrued expenses

(662)

477

   

Deferred Revenue

47

(377)

 

Net cash flows from operating activities

(41,359)

(32,717)

         

Investing activities:

   
   

Purchase of equipment

(316)

(619)

 

Net cash flows from investing activities

(316)

(619)

         

Financing activities:

   
   

Equity Financing costs

40

(40)

   

Proceeds from exercise of stock options

297

480

   

Proceeds from issuance of common stock

2,460

-

   

Proceeds from exercise of common stock warrants

-

1

   

Payment on note payable

-

(3,335)

   

Proceeds from Notes Payable

-

20,667

   

Deferred Financing fees

-

(486)

   

Return on short swing profits

-

6

 

Net cash flows from financing activities

2,797

17,293

         

Net change in cash and cash equivalents

(38,878)

(16,043)

Cash and cash equivalents at beginning of year

83,560

70,472

         

Cash and cash equivalents at end of year

$           44,682

$       54,429

Cash paid for interest

$             2,045

$         1,201

 

 

 

Logo - http://photos.prnewswire.com/prnh/20110217/CL49801LOGO

SOURCE BioDelivery Sciences International, Inc.

For further information: 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