Specialty Pharmaceutical Company with a Focus in Pain and Addiction

BioDelivery Sciences Reports Strong Third Quarter 2018 Financial Results

November 14, 2018
  • 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, 
      2018 2017
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
           

dumb client is dumb.jpg

Source: BioDelivery Sciences International, Inc.