BELBUCA® Net Sales Increased 147% versus Prior Year to All-Time High of $24.1 Million
Raises Full-Year BELBUCA Net Sales Expectations to $90 - $93 Million
Raises Full-Year Total Company Net Sales Expectations to $101 - $105 Million
Raises Long-Term Combined Net Sales Expectations for BELBUCA and Symproic® to $425 - $500 Million

Conference Call and Webcast Scheduled for 4:30 PM ET Today

RALEIGH, N.C., Aug. 08, 2019 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions, today reported strong financial results for the second quarter ended June 30, 2019, as well as the following operational and performance highlights:

Key Business Highlights

“The second quarter was highlighted by dramatic accomplishments across our entire organization and has positioned us to further build upon our commercial success,” stated Herm Cukier, Chief Executive Officer of BDSI.  “We have significant momentum with our core products and have strengthened the company’s financial position.  Our excellent performance in the second quarter is the fifth consecutive quarter of sustained and rapid growth.  I believe our future is very promising, and as we raise our full-year BELBUCA and total company net sales expectations for the second time this year, we have great confidence in our growth trajectory into 2020 and beyond.” 

The company again increased its expectations for full-year 2019 BELBUCA net sales to $90 - $93 million, from the previous level of $83 - $88 million.  The company also raised its total 2019 net sales expectations to $101 - $105 million, from the previous level of $92 – $100 million.  Total net revenue expectations include $7 - $9 million of forecasted Symproic net sales, which is in line with the company’s previous expectation.  

With the strong performance achieved over the last five consecutive quarters, coupled with a solid balance sheet supporting the execution of the commercial growth plan, the company is raising its long-term combined net sales expectations for BELBUCA and Symproic to $425 - $500 million.

Second Quarter 2019 Financial Results

Total Net Revenue.  Total net revenue for the second quarter ended June 30, 2019, was $29.7 million, an increase of 50%, compared to $19.8 million in the first quarter of 2019, and an increase of 144%, compared to $12.2 million in the second quarter of 2018.

Total Net Product Sales.  Total net product sales in the second quarter were $28.1 million, an increase of 42%, compared to $19.8 million in the first quarter of 2019 and an increase of 161% compared to $10.8 million in the second quarter of 2018.  This includes net product sales of Symproic of $3.2 million in the initial quarter of commercialization following the acquisition of the product. 

BELBUCA Net Sales. BELBUCA net sales in the second quarter were $24.1 million, an increase of 29%, compared to $18.7 million in the first quarter of 2019 and an increase of 147%, compared to $9.7 million in the second quarter of 2018.

Total Operating Expenses.  Total operating expenses in the quarter ended June 30, 2019, were $22.0 million, compared to $17.0 million in the first quarter of 2019 and $14.9 million in the second quarter of 2018.

GAAP Net Loss.  GAAP net loss for the quarter was $11.1 million, or ($0.13) per share, compared to the loss of $3.8 million, or ($0.05) per share, for the first quarter of 2019 and a GAAP net loss of $9.8 million, or ($0.16) per share, in the second quarter of 2018. The increase in net loss is driven by the one-time debt refinancing costs of $11.9 million.

EBITDA.  EBITDA in the second quarter of 2019 was $4.8 million or 16.1% of total net revenue, compared to $0.1 million in the first quarter of 2019 and ($5.6) million in the second quarter of 2018.

Non-GAAP Net Income.  Non-GAAP net income for the quarter was $4.4 million and reflects GAAP net loss excluding the non-recurring costs of the debt refinancing, stock-based compensation and non-cash amortization of intangible assets and warrant discounts.

Cash Position.  BDSI had cash and cash equivalents of approximately $57.2 million as of June 30, 2019. Based on current guidance, the company anticipates having positive operating cash flow by the fourth quarter of 2019.

Conference Call & Webcast Details

BioDelivery Sciences will host a conference call and webcast today, August 8, 2019, at 4:30 p.m. ET to present second quarter 2019 results and to provide a business update.  Dial-in details are as follows:

Date: Thursday, August 8, 2019
Time:4:30 PM EDT
Domestic:800-347-6311
International:720-543-0197
Passcode:868 4665
Webcast:http://public.viavid.com/index.php?id=135544

ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology 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 chronic pain, breakthrough cancer pain, opioid dependence, and opioid-induced constipation.

CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS

This press release 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 BELBUCA net revenues and total net revenues in 2019 and the implementation and success of our Symproic strategic plan) may differ materially 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) including those set forth in our 2019 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. 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.

© 2019 BioDelivery Sciences International, Inc.  All rights reserved.

Contact:

Mary Coleman
Vice President, Investor Relations and Corporate Communications
BioDelivery Sciences International, Inc.
mcoleman@bdsi.com

 BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES  
 CONDENSED CONSOLIDATED BALANCE SHEETS  
 (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)  
 (Unaudited) 
  June 30,December 31,  
   2019  2018  
 ASSETS   
 Current assets:   
   Cash and cash equivalents$  57,215 $  43,822  
   Accounts receivable, net.   24,879    13,627  
   Inventory, net   9,974    5,406  
   Prepaid expenses and other current assets   3,298    3,188  
   Total current assets   95,366    66,043  
     
 Property and equipment, net   3,853    3,072  
 Goodwill   2,715    2,715  
 License and distribution rights, net   63,778    36,000  
 Other intangible assets, net   375    703  
   Total assets$   166,087  $   108,533   
     
 LIABILITIES AND STOCKHOLDERS' EQUITY   
 Current liabilities:   
   Accounts payable and accrued liabilities$  40,762 $  21,539  
   Total current liabilities   40,762    21,539  
     
 Notes payable, net    58,448    51,652  
 Other long-term liabilities   727    5,600  
   Total liabilities   99,937    78,791  
     
 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 June 30, 2019 and December
31, 2018, respectively; Series B Non-Voting Convertible Preferred Stock, $.001 par value,
1,716 and 3,100 shares outstanding at June 30, 2019 and December 31, 2018, respectively.		   2    2  
 Common Stock, $.001 par value; 125,000,000 shares authorized at June 30, 2019 and
December 31, 2018, respectively; 89,535,024 and 75,793,725 shares issued;89,519,533 and
70,778,234 shares outstanding at June 30, 2019 and December 31, 2018, respectively. 		   88    71  
 Additional paid-in capital   432,358    381,004  
 Treasury stock, at cost, 15,491 shares   (47)   (47) 
 Accumulated deficit   (366,251)   (351,288) 
   Total stockholders' equity    66,150    29,742  
     
 Total liabilities and stockholders' equity$   166,087  $   108,533   
     

 

 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 June 30, Six Months Ended June 30, 
   2019  2018   2019  2018  
 Revenues:      
   Product sales$  28,056 $  10,766  $  47,815 $  20,604  
   Product royalty revenues   1,461    1,386     1,471    1,826  
   Contract revenue   160    23     160    1,026  
   Total Revenues:   29,677    12,175     49,446    23,456  
        
 Cost of sales   4,923    4,566     8,975    7,981  
        
 Expenses:      
   Research and development:   -     854     -     3,338  
   Sales, general and administrative   21,955    14,021     38,944    27,526  
   Total Expenses: 21,955  14,875   38,944  30,864  
        
 Income (loss) from operations 2,799  (7,266)  1,527  (15,389) 
 Interest expense   (13,937)   (2,525)    (16,498)   (5,030) 
 Other (expense) income, net   8    1     8    (6) 
 Loss before income taxes$  (11,130)$  (9,790) $  (14,963)$  (20,425) 
        
 Income tax benefit (expense)   -     20     -   (54) 
 Net loss attributable to common stockholders$  (11,130)$  (9,770) $  (14,963)$  (20,479) 
        
 Basic and diluted      
 Weighted average common stock shares outstanding:   83,821,811    59,400,317     77,571,003    58,735,351  
 Basic and diluted loss per share:$  (0.13)$  (0.16) $  (0.19)$  (0.35) 

 

  BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES 
  CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 
  (U.S. DOLLARS, IN THOUSANDS) 
  (Unaudited)
    Six Months Ended June 30, 
     2018  2018 
 Operating activities:  
  Net loss $  (14,963)$  (20,479)
   Depreciation and amortization   168    456 
   Impairment loss on equipment   -     78 
   Accretion of debt discount and loan costs   11,374    1,782 
   Amortization of intangible assets   3,187    2,578 
   Provision for inventory obsolescence   149    412 
   Stock-based compensation expense   2,711    4,004 
  Changes in assets and liabilities, net of effect of acquisition:  
   Accounts receivable   (11,252)   (423)
   Inventories   (4,716)   (489)
   Prepaid expenses and other assets   (110)   1,454 
   Accounts payable and accrued expenses   9,078    (1,118)
  Net cash flows from operating activities (4,374) (11,745)
      
 Investing activities:  
   Product acquisitions   (20,674)   (1,951)
   Acquisitions of equipment   (79)   (122)
  Net cash flows from investing activities   (20,753)   (2,073)
      
 Financing activities:  
   Proceeds from issuance of common stock   48,000    -  
   Proceeds from issuance of Series B preferred stock   -     50,000 
   Equity financing costs   (410)   (1,509)
   Proceeds from notes payable   60,000    -  
   Proceeds from exercise of stock options   1,070    306 
   Payment of notes payable   (67,346)   -  
   Loss on refinancing of former debt   (2,794)   -  
   Payment of deferred financing fees   -     (450)
  Net cash flows from financing activities 38,520  48,347 
 Net change in cash and cash equivalents 13,393  34,529 
 Cash and cash equivalents at beginning of year   43,822    21,195 
 Cash and cash equivalents at end of year$   57,215  $   55,724  

 

 BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES  
 RECONCILIATION OF NON-GAAP METRICS 
 (U.S. DOLLARS, IN THOUSANDS)  
 (Unaudited) 
         
 Reconciliation of GAAP net income/(loss) to
EBITDA (non-GAAP)		 Three Months Ended
June 30,		 Six Months Ended
June 30,		 
   2019  2018   2019  2018  
         
 GAAP net income/(loss) $   (11,130)$   (9,770) $  (14,963)$  (20,479) 
   Add back:       
   Provision for income taxes  -  (20)  -  53  
   Net interest expense  13,929  2,525   16,490  5,037  
   Depreciation and amortization  1,981  1,679   3,356  3,199  
 EBITDA $   4,780  $   (5,586) $   4,883  $  (12,190) 
         
 Reconciliation of GAAP net income/(loss) to
non-GAAP net income/(loss)		       
        
         
 GAAP net income/(loss) $   (11,130)$   (9,770) $  (14,963)$  (20,479) 
   Non-GAAP adjustments:       
   Stock-based compensation expense  1,569  1,084   2,712  4,005  
   Amortization of intangible assets  1,898  1,289   3,187  2,578  
   Amortization of warrant discount  179  269   448  538  
   Non-recurring financial impact of debt refinance 11,866  -   11,866  -  
 Non-GAAP net income/(loss) $   4,382  $   (7,128) $   3,250  $  (13,358)