• BELBUCA® continued on an accelerated growth trajectory, with revenue increasing 92% YOY and 27% versus prior quarter
  • BELBUCA total prescriptions experienced its largest quarter over quarter increase since launch

Conference Call And Webcast Scheduled For 4:30 PM ET Today

RALEIGH, N.C., Nov. 08, 2018 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing commercial stage specialty pharmaceutical company dedicated to patients living with chronic pain, today reported record financial results for the third quarter ending September 30, 2018, as well as the following operational and performance highlights:

Third Quarter Operational Highlights Include

  • Achieved strong BELBUCA® revenue performance with sales increasing to $12.4 million, up 92% YOY and 27% versus prior quarter
     
  • Sustained robust BELBUCA prescription growth achieving a new high of 44,180 TRxs, up 95% versus prior year and 25% versus prior quarter.  The quarterly increase of 8,690 scripts versus prior quarter was the highest for the product since launch
     
  • Secured expanded market access for Belbuca to an additional 25 million lives, bringing the total population with preferred coverage to more than 75 million covered lives
     
  • Successfully began implementing its four point Belbuca strategic plan for sustained growth, including expanding the sales organization by more than 30% and starting to build the new medical team
     
  • Strengthened the executive leadership team with appointment of James Vollins as Company General Counsel, Chief Compliance Officer and Corporate Secretary

“I am very pleased by the results achieved during the third quarter across the organization,” stated Herm Cukier, CEO of BDSI. “Our continued focus on commercial execution enabled us to achieve very robust growth for BELBUCA and created a sizeable foundation to further build shareholder value for the long term.  We also started implementing our previously announced four point BELBUCA strategic plan during the quarter, and were thrilled to strengthen our leadership team with the hiring of our new General Counsel.  These elements of growth momentum and continued progress put us in a strong position to finish the year strong and build for future success.”

With the performance achieved through the first three quarters, and a strong balance sheet supporting the execution of the BELBUCA growth plan, the company is expecting total year 2018 financial performance for BELBUCA and total Company net revenue to be in the upper end of previous guidance.

Third Quarter 2018 Financial Results

Total Net Revenue.  Total net revenue for the third quarter ended September 30, 2018, was $14.2 million, an increase of 16% compared to $12.2 million in the second quarter of 2018, and an increase of 26% compared to $11.3 million in the third quarter of 2017.

BELBUCA® Net Revenue. BELBUCA net revenue in the third quarter ended September 30, 2018, was $12.4 million, an increase of 27% compared to second quarter 2018 revenue of $9.7 million, and an increase of 92% compared to third quarter 2017 revenue of $6.4 million.

Total Operating Expenses.  Total operating expenses for the third quarter ended September 30, 2018, were $14.2 million, compared to second quarter 2018 expenses of $14.9 million, and third quarter 2017 expenses of $16.9 million.

Non-GAAP Net Loss for the third quarter of 2018 was $6.4 million or ($0.10) per share, compared to second quarter 2018 net loss of $9.8 million, or ($0.16) per diluted share, and a third quarter 2017 net loss of $12.0 million, or ($0.21) per diluted share.

GAAP Net Loss for the third quarter ended September 30, 2018 was $18.9 million, or ($0.29) per basic and diluted share, including a one-time non-cash charge of $12.5 million for the beneficial conversion feature of the Series B Preferred Stock.

Cash Position.  At September 30, 2018, BDSI had cash and cash equivalents of approximately $49.5 million.

Conference Call & Webcast Details

BioDelivery Sciences will host a conference call and audio webcast today, November 8, 2018 at 4:30 p.m. ET to present third quarter 2018 results and provide a business update.  Dial-in details are as follows:

Domestic: 800-479-1004
International: 323-794-2599
Passcode: 9394131
Webcast:  http://public.viavid.com/index.php?id=131852
   
Replays available through November 22, 2018
Domestic:  844-512-2921
International: 412-317-6671
Conference ID: 9394131

About BioDelivery Sciences International, Inc.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic pain.  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 marketed products and those in development address serious and debilitating conditions such as breakthrough cancer pain, chronic pain 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.  For full prescribing information and important safety information on BDSI products 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, the presentation described herein, and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. ("BDSI") 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 BDSI'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 BDSI's management and are subject to significant risks and uncertainties, including those detailed in the BDSI's filings with the Securities and Exchange Commission.  Actual results (including, without limitation, the continued growth in revenue and Belbuca prescription, and the implementation and success of our Belbuca strategic plan) may differ significantly from those set forth or implied 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 BDSI's control).  BDSI 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.

© 2018 BioDelivery Sciences International, Inc.  All rights reserved.

Contacts
Mary Coleman
Vice President, Investor Relations
BioDelivery Sciences International, Inc.
919-582-9050
mcoleman@bdsi.com 

Monique Kosse
Managing Director
LifeSci Advisors
212-915-3820
monique@lifesciadvisors.com 

 
 
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, 
 2018 2017
ASSETS      
Current assets:      
Cash and cash equivalents$49,482 $21,195 
Accounts receivable 12,568  8,852 
Inventory 5,434  6,091 
Prepaid expenses and other current assets 4,155  3,610 
Total current assets 71,639  39,748 
       
Property and equipment, net 3,170  3,778 
Goodwill 2,715  2,715 
BELBUCA license and distribution rights, net 37,125  40,500 
Other intangible assets, net 867  1,360 
Total assets$   115,516  $   88,101  
       
LIABILITIES AND STOCKHOLDERS' EQUITY      
Current liabilities:      
Accounts payable and accrued liabilities$23,919 $26,149 
Total current liabilities 23,919  26,149 
       
Notes payable, net 50,516  47,660 
Other long-term liabilities 5,511  5,415 
Total liabilities 79,946  79,224 
       
Commitments and contingencies      
       
Stockholders' equity:      
Preferred Stock, 5,000,000 shares authorized; Series A Non-Voting Convertible Preferred Stock. $.001 par value, 2,093,155 shares outstanding at both September 30, 2018 and December 31, 2017, respectively; Series B Non-Voting Convertible Preferred Stock, $.001 par value, 3,100 and 0 shares outstanding at September 30, 2018 and December 31, 2017, respectively. 2  2 
Common Stock, $.001 par value; 125,000,000 and 75,000,000 shares authorized at September 30, 2018 and December 31, 2017, respectively; 70,598,687 and 55,904,072 shares issued;70,583,196 and 55,888,581 shares outstanding at September 30, 2018 and December 31, 2017, respectively. 71  56 
Additional paid-in capital 379,824  313,922 
Treasury stock, at cost, 15,491 shares (47) (47)
Accumulated deficit (344,280) (305,056)
Total stockholders' equity 35,570  8,877 
       
Total liabilities and stockholders' equity$   115,516  $   88,101  
   
   

 

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,
  2018  2017   2018  2017 
Revenues:     
Product sales$13,763 $8,118  $34,367 $23,798 
Product royalty revenues 370  1,409   2,197  3,682 
Research and development reimbursements -  532   -  799 
Contract revenue 23  1,194   1,047  21,194 
Total Revenues: 14,156  11,253   37,611  49,473 
              
Cost of sales 3,779  4,445   11,760  14,261 
              
Expenses:             
Research and development: 699  1,986   4,038  6,246 
Sales, general and administrative 13,489  14,867   41,013  44,094 
Total Expenses: 14,188  16,853   45,051  50,340 
              
Loss from operations (3,811) (10,045)  (19,200) (15,128)
Interest expense (2,567) (1,893)  (7,598) (6,657)
Other expense, net (2) (13)  (8) (28)
Bargain purchase gain -  -   -  27,336 
(Loss) income before income taxes$(6,380)$(11,951) $(26,806)$5,523 
              
Income tax benefit -  -   (53) 15,972 
Net (loss) income$(6,380)$(11,951) $(26,859)$21,495 
Beneficial conversion feature of convertible preferred stock (12,500) -   (12,500) - 
Net (loss) income attributable to common stockholders$(18,880)$(11,951) $(39,359)$21,495 
              
Basic:             
Basic (loss) income per share:$(0.29)$(0.21) $(0.65)$0.39 
Weighted average common stock shares outstanding: 64,900,007  55,604,708   60,599,456  55,170,569 
              
Diluted:             
Diluted (loss) income per share:$(0.29)$(0.21) $(0.65)$0.38 
Weighted average common stock shares outstanding: 64,900,007  55,604,708   60,599,456  56,204,358 
              
              

 

 BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES 
 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 
 (U.S. DOLLARS, IN THOUSANDS) 
 (Unaudited)
   Nine Months Ended September 30, 
   20182017
Operating activities:  
 Net (loss) income$(26,859)$21,495 
  Depreciation 685  465 
  Accretion of debt discount and loan costs 2,953  1,941 
  Amortization of intangible assets 3,868  4,103 
  Impairment loss on equipment 78  - 
  Provision for inventory obsolescence 396  - 
  Stock-based compensation expense 4,896  10,223 
  Deferred income taxes -  (15,972)
  Bargain purchase gain -  (27,336)
 Changes in assets and liabilities, net of effect of acquisition:      
  Accounts receivable (3,581) (7,222)
  Inventories 261  2,314 
  Prepaid expenses and other assets (545) 1,826 
  Accounts payable and accrued expenses (427) 8,998 
  Deferred Revenue -  (21,716)
 Net cash flows from operating activities (18,275) (20,881)
         
Investing activities:      
  BELBUCA acquisition (1,951) (3,902)
  Purchase of equipment (155) (5)
 Net cash flows from investing activities (2,106) (3,907)
         
Financing activities:      
  Proceeds from issuance of Series B preferred stock 50,000  - 
  Equity financing costs (1,410) - 
  Proceeds from notes payable -  45,000 
  Proceeds from exercise of stock options 528  313 
  Payment of notes payable -  (30,000)
  Payment of deferred financing fees (450) (2,798)
 Net cash flows from financing activities 48,668  12,515 
Net change in cash and cash equivalents 28,287  (12,273)
Cash and cash equivalents at beginning of year 21,195  32,019 
Cash and cash equivalents at end of year$   49,482  $   19,746  
Cash paid for interest$4,645 $3,816 
       
       

 

BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES 
(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS) 
(Unaudited)
       
  Three Months Ended September 30, Nine Months Ended September 30,
  2018
2017
 2018
2017
       
Basic:     
 Net (loss) income under GAAP$(18,880)$(11,951) $(39,359)$21,495
 Adjustment to beneficial conversion feature of convertible preferred stock 12,500  -   12,500  -
 Net (loss) income attributable to common stockholders' Non-GAAP (6,380) (11,951)  (26,859) 21,495
 Weighted average common stock shares outstanding: 64,900,007  55,604,708   60,599,456  55,170,569
 Basic (loss) income per common share$   (0.10)$   (0.21) $   (0.44)$   0.39
              
Diluted:            
 Net (loss) income under GAAP$(18,880)$(11,951) $(39,359)$21,495
 Adjustment to beneficial conversion feature of convertible preferred stock 12,500  -   12,500  -
 Net (loss) income attributable to common stockholders' Non-GAAP (6,380) (11,951)  (26,859) 21,495
 Weighted average common stock shares outstanding: 64,900,007  55,604,708   60,599,456  55,170,569
 Effect of dilutive options and warrants -  -   -  1,033,789
 Diluted weighted average common shares outstanding 64,900,007  55,604,708   60,599,456  56,204,358
 Diluted (loss) income per common share$   (0.10)$   (0.21) $   (0.44)$   0.38
              
              

 

BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES 
(Unaudited)
      
 Three Months Ended September 30, Nine Months Ended September 30,
 2018
2017
 2018
2017
      
Diluted EPS under GAAP$(0.29)$(0.21) $(0.65)$0.38
Diluted EPS adjustment to beneficial conversion feature of convertible preferred stock 0.19  -   0.21  -
Diluted EPS Non-GAAP$(0.10)$(0.21) $(0.44)$0.38