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News Release

BioDelivery Sciences Reports Strong Q2 2020 Results

August 5, 2020 at 7:45 AM EDT

Second Quarter Total Company Net Revenue Increased 23% versus Prior Year to $36.6 Million

Second Quarter BELBUCA® Net Sales Increased 34% versus Prior Year to $32.3 Million

BELBUCA and Symproic® Each Reach All Time High TRx Volume and Market Share

Conference Call and Webcast Scheduled for 8:30 AM EST Today

RALEIGH, N.C., Aug. 05, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today reported strong financial results for the second quarter ended June 30, 2020, as well as the following operational and performance highlights.

Key Business Highlights

  • Total Company net revenue for the second quarter increased by 23% versus the prior year period to $36.6 million. This growth was driven by BELBUCA net sales of $32.3 million, an increase of 34% versus the prior year period, and Symproic net sales of $3.4 million, an increase of 7% compared to the second quarter of 2019.
  • Total BELBUCA prescriptions reached an all-time high of 104,687 during the second quarter, representing year-over-year prescription volume growth of 31%.
  • Total Symproic prescriptions were more than 17,200 in the second quarter, representing growth of 11% versus the prior year.
  • Appointed Jeffrey A. Bailey as interim Chief Executive Officer (CEO).
  • Successfully adapted commercial model in response to evolving COVID-19 market conditions, which included a reduction in patient visits to physicians.  This was demonstrated by robust brand performance year over year, while also tightly managing expenses to drive positive net income.

“Our business has proven to be extremely resilient during the second quarter as seen with the all-time high TRx volume and market shares achieved for both BELBUCA and Symproic,” stated Jeff Bailey, interim CEO of BDSI. “BDSI is in the best financial position it has ever been from a cash and profitability perspective, and fundamentally the demand for BELBUCA and Symproic is strong, positioning the company well to continue supporting our commercial team with new and enhanced tools adapted for the current environment.”

Second Quarter 2020 Financial Results

Total Company Net Revenue for the second quarter of 2020 was $36.6 million, an increase of 23% compared to $29.7 million in the second quarter of 2019, and a decrease of 4% compared to $38.3 million in the first quarter of 2020.

BELBUCA Net Sales for the second quarter of 2020 were $32.3 million, an increase of 34% compared to $24.1 million in the second quarter of 2019, and a decrease of 3% compared to $33.5 million in the first quarter of 2020.

Symproic Net Sales for the second quarter were $3.4 million, an increase of 7% compared to $3.2 million in the second quarter of 2019, and a decrease of 18% compared to $4.2 million in the first quarter of 2020.

BUNAVAIL Net Sales for the second quarter were $0.7 million, compared to $0.8 million in the second quarter of 2019. In March of this year, the Company announced the planned discontinuation of marketing of BUNAVAIL and ceased shipping product on June 15, 2020.

Total Operating Expenses for the second quarter of 2020 were $28.2 million, compared to $26.7 million in the first quarter of 2020 and $22.0 million in the second quarter of 2019. Second quarter costs declined $3.6 million compared to the first quarter of 2020, excluding the $5.1 million of non-recurring costs related to the CEO transition.

GAAP Net Income for the second quarter of 2020 was $1.2 million, or $0.01 per share, compared to GAAP net income of $5.0 million, or $0.05 per share, for the first quarter of 2020 and GAAP net loss of $11.1 million, or ($0.13) per share, in the second quarter of 2019.

EBITDA for the second quarter of 2020 was $5.1 million, or 14% of net sales, compared to $7.8 million in the first quarter of 2020 and $4.8 million in the second quarter of 2019.

Non-GAAP Net Income for the second quarter of 2020 was $9.6 million and reflects GAAP net income excluding stock-based compensation, non-cash amortization of intangible assets, non-recurring financial impact of the BUNAVAIL discontinuation and the non-recurring financial impact of the CEO transition.

Cash Position: As of June 30, 2020, cash and cash equivalents were approximately $91.0 million, compared to $63.9 million at December 31, 2019, reflecting the generation of $5.0 million of positive operating cash flow and $2.5 million in proceeds from the exercise of options, together with $19.6 million of net proceeds from increasing our existing credit facility.

“A very important objective through this COVID-19 pandemic has been to ensure the health and safety of our employees and the communities we serve,” stated Jeff Bailey. “Lastly, I’d like to thank the entire BDSI team for their commitment and continued focus on meeting patient needs.”

Conference Call & Webcast Details

BioDelivery Sciences will host a conference call and webcast today, August 5, 2020, at 8:30 a.m. ET to present second quarter 2020 results and to provide a business update.  Dial-in details are as follows:

Date:  Wednesday, August 5, 2020
Time: 8:30 AM Eastern Time
Domestic: 866-248-8441
International: 720-452-9102
Conference ID: 9339657
Webcast: http://public.viavid.com/index.php?id=141000

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 address serious and debilitating conditions, including chronic pain 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 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 BDSI’s management and are subject to significant risks and uncertainties, including those detailed in BDSI’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the continued growth in BELBUCA and Symproic net sales and total company net revenue in 2020 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 BDSI’s control) including the risk that the current coronavirus pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcare facilities in which they work, and our personnel are greater than we anticipate, as well as 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.

Non-GAAP Financial Measures

This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States, or GAAP, including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.

Non-GAAP net income adjusts for one-time and non-cash charges by excluding the following from GAAP net income: stock-based compensation expense, amortization of intangible assets, amortization of certain warrant discount costs in second quarter 2019, and the financial impact of certain one-time items that are non-recurring, including the financial impact of the debt refinancing in second quarter 2019, the discontinuation of marketing of BUNAVAIL, and costs associated with the CEO transition.

EBITDA excludes net interest, including both interest expenses and interest income, provision for (benefit from) income taxes, depreciation and amortization.

The Company's management and board of directors utilize these non-GAAP financial measures to evaluate the Company's performance. The Company provides these non-GAAP measures of the Company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of our liquidity.

A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release.

© 2020 BioDelivery Sciences International, Inc.  All rights reserved.

Contact:

Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.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,
2020
  December 31,
2019
ASSETS          
Current assets:          
Cash and cash equivalents     $ 91,009     $ 63,888  
Accounts receivable, net     48,126     38,790  
Inventory, net     17,774     11,312  
Prepaid expenses and other current assets     2,099     3,769  
Total current assets     159,008     117,759  
Property and equipment, net     1,508     2,075  
Goodwill     2,715     2,715  
License and distribution rights, net     56,842     60,309  
Other intangible assets, net         47  
Total assets     $ 220,073     $ 182,905  
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable and accrued liabilities     $ 56,646     $ 53,993  
Total current liabilities     56,646     53,993  
Notes payable, net     78,274     58,568  
Other long-term liabilities     383     580  
Total liabilities     135,303     113,141  
Commitments and contingencies          
Stockholders’ equity:          
Preferred Stock, 5,000,000 shares authorized; Series A Non-Voting Convertible Preferred Stock. $0.001 par value, 0 and 2,093,155 shares outstanding at June 30, 2020 and December 31, 2019, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 and 618 shares outstanding at June 30, 2020 and December 31, 2019, respectively.       2  
Common Stock, $0.001 par value; 175,000,000 shares authorized at June 30, 2020 and December 31, 2019, respectively; 100,916,511 and 96,189,074 shares issued; 100,901,020 and 96,173,583 shares outstanding at June 30, 2020 and December 31, 2019, respectively.   99     96  
Additional paid-in capital     445,180     436,306  
Treasury stock, at cost,15,491 shares, as of June 30, 2020 and December 31, 2019.     (47 )   (47 )
Accumulated deficit     (360,462 )   (366,593 )
Total stockholders’ equity     84,770     69,764  
Total liabilities and stockholders’ equity     $ 220,073     $ 182,905  



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,
  2020   2019   2020   2019
Revenues:              
Product sales $ 36,445     $ 28,056     $ 74,161     $ 47,815  
Product royalty revenues 137     1,461     700     1,471  
Contract revenues     160         160  
    Total Revenues: 36,582     29,677     74,861     49,446  
Cost of sales 5,435     4,923     10,995     8,975  
Expenses:              
Selling, general and administrative 28,211     21,955     54,948     38,944  
    Total Expenses: 28,211     21,955     54,948     38,944  
Income/(loss) from operations 2,936     2,799     8,918     1,527  
Interest expense, net (1,693 )   (13,937 )   (2,987 )   (16,498 )
Other income, net 8     8     8     8  
Income/(loss) before income taxes $ 1,251     $ (11,130 )   $ 5,939     $ (14,963 )
Income tax recovery/(provision) (86 )       192      
Net income/(loss) attributable to common stockholders $ 1,165     $ (11,130 )   $ 6,131     $ (14,963 )
Basic              
Weighted average common stock shares outstanding 100,136,893     83,821,811     98,541,877     77,571,003  
Basic earnings/(loss) per share $ 0.01     $ (0.13 )   $ 0.06     $ (0.19 )
Diluted              
Weighted average common stock shares outstanding 108,111,201     83,821,811     107,062,161     77,571,003  
Diluted earnings/(loss) per share $ 0.01     $ (0.13 )   $ 0.06     $ (0.19 )



BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. DOLLARS, IN THOUSANDS)
(Unaudited)

  Six months ended June 30
  2020   2019
Operating activities:      
Net income/(loss) $ 6,131     $ (14,963 )
Adjustments to reconcile net income/(loss) to net cash flows from operating activities      
Depreciation and amortization 446     168  
Accretion of debt discount and loan costs 142     11,374  
Amortization of intangible assets 3,515     3,187  
Provision for inventory obsolescence 72     149  
Stock-based compensation expense 6,306     2,711  
Changes in assets and liabilities:      
Accounts receivable (9,336 )   (11,252 )
Inventories (6,534 )   (4,716 )
Prepaid expenses and other assets 1,670     (110 )
Accounts payable and accrued liabilities 2,617     9,078  
Taxes payable (40 )    
Net cash flows provided by/(used in) operating activities 4,989     (4,374 )
Investing activities:      
Product acquisitions     (20,674 )
Acquisitions of equipment     (79 )
Net cash flows used in investing activities     (20,753 )
Financing activities:      
Proceeds from issuance of common stock     48,000  
Equity issuance costs     (410 )
Proceeds from notes payable 20,000     60,000  
Proceeds from exercise of stock options 2,569     1,070  
Payment on note payable     (67,346 )
Loss on refinancing of former debt     (2,794 )
Payment on deferred financing fees (437 )    
Net cash flows provided by financing activities 22,132     38,520  
Net change in cash and cash equivalents 27,121     13,393  
Cash and cash equivalents at beginning of period 63,888     43,822  
Cash and cash equivalents at end of period $ 91,009     $ 57,215  



BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

RECONCILIATION OF NON-GAAP METRICS
(U.S. DOLLARS, IN THOUSANDS)
(Unaudited)

  Three Months Ended
June 30,
  Three Months Ended
March 31,
  Six Months Ended
June 30,
Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) 2020 2019
  2020   2020
2019
GAAP net income/(loss) $ 1,165  $ (11,130 )   $ 4,966      $ 6,131    $ (14,963 )
Add back/(subtract):                              
Income tax recovery/(provision)   86       (278 )     (192 )    
Net interest expense   1,685   13,929     1,294       2,979     16,490  
Depreciation and amortization   2,159   1,981     1,802       3,960     3,356  
EBITDA $ 5,095 $ 4,780     $ 7,784     $ 12,878   $ 4,883  
Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)                              
GAAP net income/(loss) $ 1,165 $ (11,130 )   $ 4,966     $ 6,131   $ (14,963 )
Non-GAAP adjustments:                              
Stock-based compensation expense   1,364   1,569     1,520       6,305     2,712  
Amortization of intangible assets   1,734   1,898     1,781       93     3,187  
Amortization of warrant discount     179               448  
Non-recurring financial impact of debt refinance     11,866               11,866  
Non-recurring financial impact of CEO transition   5,078             5,078      
Non-recurring financial impact of BUNAVAIL discontinuation   295             295      
Non-GAAP net income/(loss) $ 9,636 $ 4,382     $ 8,267     $ 17,902   $ 3,250  

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Source: BioDelivery Sciences International