BDSI BioDelivery Sciences International Inc.

3.73
-0.04  -1%
Previous Close 3.77
Open 3.71
52 Week Low 2.85
52 Week High 7.21
Market Cap $376,485,137
Shares 100,934,353
Float 94,776,505
Enterprise Value $367,787,510
Volume 1,341,574
Av. Daily Volume 1,191,209
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
BEMA Buprenorphine
Pain
Approved
Approved
Approved October 26, 2015.
Clonidine gel
Painful diabetic neuropathy (PDN)
Phase 2b
Phase 2b
Phase 2b data released December 13, 2016 - primary endpoints not met.
BEMA Buprenorphine/Naloxone (BNX) - BUNAVAIL
Opioid dependence
Approved
Approved
Approved June 6, 2014.

Latest News

  1. RALEIGH, N.C., Sept. 11, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with chronic conditions, today announced the presentation of five scientific posters highlighting data regarding BELBUCA at the 14th Annual PAINWeek 2020 National Conference on Pain Management taking place virtually September 11-13, 2020.

    Poster Presentations:

    1. A Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride: Pupillometry

      Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD
    1. Secondary Outcomes of a Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine

    RALEIGH, N.C., Sept. 11, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with chronic conditions, today announced the presentation of five scientific posters highlighting data regarding BELBUCA at the 14th Annual PAINWeek 2020 National Conference on Pain Management taking place virtually September 11-13, 2020.

    Poster Presentations:

    1. A Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride: Pupillometry



      Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD
    1. Secondary Outcomes of a Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride on Respiratory Drive



      Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD
    1. Key Outcomes of a Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride on Respiratory Drive



      Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD
    1. The Pharmacodynamics and Pharmacokinetics of Buprenorphine Buccal Film Versus Oral Oxycodone Hydrochloride: Results of a Phase I Placebo-Controlled Trial



      Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD
    1. Buprenorphine Buccal Film in Patients with Chronic Low Back Pain: A Pooled Subgroup Analysis of Two Double-Blind, Placebo-Controlled, Randomized Withdrawal Trials by Baseline Pain Severity



      Authors: Christine Moore, PhD; P. Hunter Allman, PhD; Gary Cutter, PhD

    "We are very pleased to have this data being presented this year at PAINWeek 2020, the largest pain conference in the US," said Thomas Smith, MD, Chief Medical Officer of BDSI. "This new information adds to the growing awareness and appreciation of BELBUCA as an important treatment option for patients suffering from chronic pain."

    All five posters will be available for public viewing by visiting the PAINWeek Conference website following the conclusion of the Conference.

    Important Safety Information About BELBUCA®

    BELBUCA® (buprenorphine buccal film), CIII is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

    Limitations of Use

    Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations, reserve BELBUCA® for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

    BELBUCA® is not indicated as an as-needed (prn) analgesic.

    WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS



    Addiction, Abuse, and Misuse

    BELBUCA® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk prior to prescribing BELBUCA® and monitor patients regularly for these behaviors and conditions.



    Risk Evaluation and Mitigation Strategy (REMS)

    To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

    • complete a REMS-compliant education program,
    • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
    • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
    • consider other tools to improve patient, household, and community safety.
    Life-Threatening Respiratory Depression

    Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA®. Monitor for respiratory depression, especially during initiation of BELBUCA® or following a dose increase.



    Accidental Exposure

    Accidental exposure to even one dose of BELBUCA®, especially by children, can result in a fatal overdose of buprenorphine.



    Neonatal Opioid Withdrawal Syndrome

    Prolonged use of BELBUCA® during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.



    Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

    Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

    BELBUCA® is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and hypersensitivity (e.g., anaphylaxis) to buprenorphine.

    BELBUCA® contains buprenorphine, a Schedule III controlled substance. As an opioid, BELBUCA® exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed BELBUCA® and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused.

    Potential serious adverse events caused by opioids include addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; risks due to interactions with benzodiazepines or other central nervous system depressants; risk of life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients; adrenal insufficiency; QTc prolongation; severe hypotension; risks of use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness; hepatotoxicity; risk of overdose in patients with moderate or severe hepatic impairment; anaphylactic/allergic reactions; risk of use in patients with gastrointestinal conditions; increased risk of seizures in patients with seizure disorders; risks of use in cancer patients with oral mucositis; risks of driving and operating machinery.

    The most common adverse reactions (≥5%) reported by patients treated with BELBUCA® in the clinical trials were nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infection.

    For full Prescribing Information, including Boxed Warning, visit www.belbuca.com.

    To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc. at 1-800-469-0261 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

    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.

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

    Contact:

    Terry Coelho

    Chief Financial Officer

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989

    Primary Logo

    View Full Article Hide Full Article
  2. RALEIGH, N.C., Sept. 03, 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 announced that Jeffrey Bailey, Interim Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will present at two upcoming virtual investor conferences in September. The management team will also host one-on-one investor meetings at the conferences.

    Presentation Details:

    Event: H.C. Wainwright 22nd Annual Global Investor Conference
    Date: Monday, September 14, 2020
    Time: 12:30pm Eastern Time
    Webcast: https://wsw.com/webcast/hcw7/bdsi/1590962

    Event: Cantor Fitzgerald Global Healthcare Conference…

    RALEIGH, N.C., Sept. 03, 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 announced that Jeffrey Bailey, Interim Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will present at two upcoming virtual investor conferences in September. The management team will also host one-on-one investor meetings at the conferences.

    Presentation Details:

    Event: H.C. Wainwright 22nd Annual Global Investor Conference

    Date: Monday, September 14, 2020

    Time: 12:30pm Eastern Time

    Webcast: https://wsw.com/webcast/hcw7/bdsi/1590962

    Event: Cantor Fitzgerald Global Healthcare Conference

    Date: Thursday, September 17, 2020

    Time: 11:20am Eastern Time

    Webcast: https://www.webcaster4.com/Webcast/Page/2495/37347

    A replay of the presentations will be archived on the Company's website and made available for 60 days.

    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.

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

    Contact:

    Terry Coelho

    Chief Financial Officer

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989

    Primary Logo

    View Full Article Hide Full Article
  3. 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 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



    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 revenues137  1,461  700  1,471 
    Contract revenues  160    160 
        Total Revenues:36,582  29,677  74,861  49,446 
    Cost of sales5,435  4,923  10,995  8,975 
    Expenses:       
    Selling, general and administrative28,211  21,955  54,948  38,944 
        Total Expenses:28,211  21,955  54,948  38,944 
    Income/(loss) from operations2,936  2,799  8,918  1,527 
    Interest expense, net(1,693) (13,937) (2,987) (16,498)
    Other income, net8  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 outstanding100,136,893  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 outstanding108,111,201  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 amortization446  168 
    Accretion of debt discount and loan costs142  11,374 
    Amortization of intangible assets3,515  3,187 
    Provision for inventory obsolescence72  149 
    Stock-based compensation expense6,306  2,711 
    Changes in assets and liabilities:   
    Accounts receivable(9,336) (11,252)
    Inventories(6,534) (4,716)
    Prepaid expenses and other assets1,670  (110)
    Accounts payable and accrued liabilities2,617  9,078 
    Taxes payable(40)  
    Net cash flows provided by/(used in) operating activities4,989  (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 payable20,000  60,000 
    Proceeds from exercise of stock options2,569  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 activities22,132  38,520 
    Net change in cash and cash equivalents27,121  13,393 
    Cash and cash equivalents at beginning of period63,888  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) 20202019

     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 

    Primary Logo

    View Full Article Hide Full Article
  4. RALEIGH, N.C., July 27, 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 announced that it will report its second quarter 2020 financial results before the open of the U.S. financial markets on Wednesday, August 5, 2020. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    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

    RALEIGH, N.C., July 27, 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 announced that it will report its second quarter 2020 financial results before the open of the U.S. financial markets on Wednesday, August 5, 2020. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    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.

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

    Contact:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

     

    Primary Logo

    View Full Article Hide Full Article
  5. RALEIGH, N.C., May 29, 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 announced that Jeffrey Bailey, Interim Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will present at two upcoming investor conferences in June. The management team will also host one-on-one investor meetings at the conferences.

    Presentation Details:

    Event: Jefferies Virtual Healthcare Conference
    Date: Tuesday, June 2, 2020
    Time: 3:00pm Eastern Time
    Webcast: http://wsw.com/webcast/jeff126/bdsi/  

    Event: William Blair 40th Annual Growth Stock Conference
    Date: Thursday, June 11, 2020
    Time: 8:40am…

    RALEIGH, N.C., May 29, 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 announced that Jeffrey Bailey, Interim Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will present at two upcoming investor conferences in June. The management team will also host one-on-one investor meetings at the conferences.

    Presentation Details:

    Event: Jefferies Virtual Healthcare Conference
    Date: Tuesday, June 2, 2020
    Time: 3:00pm Eastern Time
    Webcast: http://wsw.com/webcast/jeff126/bdsi/  

    Event: William Blair 40th Annual Growth Stock Conference
    Date: Thursday, June 11, 2020
    Time: 8:40am Central Time / 9:40am Eastern Time
    Webcast: http://www.wsw.com/webcast/blair56/bdsi/

    A replay of the presentations will be archived on the Company's website and made available for 60 days.
                 
    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, opioid dependence, and opioid-induced constipation.

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

    Contact:

    Terry Coelho
    Chief Financial Officer
     

    Bob Yedid
    LifeSci Advisors
    (646) 597-6989
     

    Primary Logo

    View Full Article Hide Full Article
View All BioDelivery Sciences International Inc. News