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CST: 14/10/2019 20:52:46   

BioDelivery Sciences Reports Strong Second Quarter 2019 Results and Raises Net Sales Expectations

67 Days ago

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

  • Total company net revenue increased by 144% versus the prior year period to a new all-time high of $29.7 million.  This growth was driven by BELBUCA® (buprenorphine buccal film), CIII sales of $24.1 million, an increase of 147% versus the prior year period, and the addition of Symproic® (naldemedine) tablets 0.2 mg to the commercial portfolio.
     
  • Total BELBUCA prescriptions of more than 80,000 for the quarter was the highest ever for any three-month period.  In addition, prescription growth for BELBUCA reached an all-time year-over-year record increase of 44,560 prescriptions, representing a 125% increase year-over-year and a 23% increase versus the prior quarter.
     
  • Achieved a new all-time high of 6,579 unique BELBUCA prescribers during the quarter.
     
  • Delivered highest ever number of quarterly prescriptions for Symproic achieving greater than 14% quarter-over-quarter growth and 40% growth versus prior year.
     
  • Significantly strengthened financial position through debt refinancing, dramatically lowering cost of capital and extending maturity.

“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 )  
                 

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