1. RALEIGH, N.C., Feb. 17, 2021 (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 fourth quarter and full year 2020 financial results before the open of the U.S. financial markets on Wednesday, March 10, 2021. 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, March 10, 2021
    Time:8:30 AM Eastern Time
    Domestic:877-407-0789
    International:201-689-8562
    Conference ID:13715530
    Webcast:http://public.viavid.com/index.php?id=143193

    RALEIGH, N.C., Feb. 17, 2021 (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 fourth quarter and full year 2020 financial results before the open of the U.S. financial markets on Wednesday, March 10, 2021. 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, March 10, 2021
    Time:8:30 AM Eastern Time
    Domestic:877-407-0789
    International:201-689-8562
    Conference ID:13715530
    Webcast:http://public.viavid.com/index.php?id=143193

    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.

    © 2021 BioDelivery Sciences International, Inc. All rights reserved.

    Contact:

    Bob Yedid

    LifeSci Advisors

    646-597-6989



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  2. RALEIGH, N.C., Feb. 11, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with chronic conditions, promoted its Chief Financial Officer, Terry Coelho, to Executive Vice President and Chief Financial Officer.

    "Terry has been a key contributor to the Company's strong performance during her tenure at BDSI, even more so through the uncertainties of the past year with the pandemic, and she has a proven record of success," said Jeff Bailey, CEO of BDSI. "Her leadership across all aspects of the business, including strategy, talent development and operations, along with her expanded responsibilities, is greatly valued and will be an increasingly…

    RALEIGH, N.C., Feb. 11, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with chronic conditions, promoted its Chief Financial Officer, Terry Coelho, to Executive Vice President and Chief Financial Officer.

    "Terry has been a key contributor to the Company's strong performance during her tenure at BDSI, even more so through the uncertainties of the past year with the pandemic, and she has a proven record of success," said Jeff Bailey, CEO of BDSI. "Her leadership across all aspects of the business, including strategy, talent development and operations, along with her expanded responsibilities, is greatly valued and will be an increasingly important asset to the Company as we advance into our next growth stage."

    Terry joined BDSI as CFO in January 2019. Under Terry's stewardship and teamwork, the Company has achieved profitability and strengthened its balance sheet. She has also led a number of key initiatives, including streamlining and improving processes and systems, as well as improving planning, reporting and controls, to name just a few. With more than 30 years of experience as a multinational finance leader and executive across various industries, Terry has demonstrated excellence in leading major change initiatives, turnarounds, and startups. She has held various senior finance and general management positions at companies including Balchem Corporation, Diversey, Inc., Novartis and Mars Inc.

    Terry holds an MBA in Finance from IBMEC in Brazil and a BA in both Economics and International Relations, summa cum laude, from The American University School of International Service in Washington, DC. She has led women's employee resource groups (ERGs) and is a founding Steering Committee Member of the CFO Leadership Council – Charlotte chapter.

    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.

    Contact:

    Terry Coelho

    Executive Vice President and Chief Financial Officer

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989



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  3. Oral Presentation of Data from Phase I Safety Study & Secondary Respiratory Outcomes
    Comparing BELBUCA® to Oxycodone on January 16 from 1:10pm – 2:10pm CT

    RALEIGH, N.C., Jan. 15, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with chronic conditions, will present three scientific posters regarding BELBUCA® (buprenorphine buccal film), CIII at the 2021 North American Neuromodulation Society Meeting (NANS) taking place virtually January 15-16, 2021.

    "We are pleased to be presenting this data at NANS 2021 and sharing this information with the scientific community," said Thomas Smith, M.D., Chief Medical Officer of BDSI.

    Data from…

    Oral Presentation of Data from Phase I Safety Study & Secondary Respiratory Outcomes

    Comparing BELBUCA® to Oxycodone on January 16 from 1:10pm – 2:10pm CT

    RALEIGH, N.C., Jan. 15, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with chronic conditions, will present three scientific posters regarding BELBUCA® (buprenorphine buccal film), CIII at the 2021 North American Neuromodulation Society Meeting (NANS) taking place virtually January 15-16, 2021.

    "We are pleased to be presenting this data at NANS 2021 and sharing this information with the scientific community," said Thomas Smith, M.D., Chief Medical Officer of BDSI.

    Data from a placebo-controlled study compared safety outcomes of BELBUCA® versus oral oxycodone. Results will be detailed in an oral presentation on Saturday, January 16 from 1:10 – 2:10pm CT and also in the following poster:

    Secondary Respiratory Outcomes of a Phase 1 Placebo-Controlled Trial: Buprenorphine Buccal Film Versus Oral Oxycodone

    Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD

    Additional poster presentations include:

    The Pharmacokinetics From a Phase 1 Placebo-Controlled Trial Comparing Buprenorphine Buccal Film and Oral Oxycodone

    Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD

    Buprenorphine Buccal Film Versus Oral Oxycodone: Effects on Pupillometry From a Phase 1 Placebo-Controlled Trial

    Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD

    All three abstracts will be available for on-demand viewing by accessing the 2021 NANS Meeting website (https://conference.neuromodulation.org/) beginning January 15th through April 16th.

    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.

    © 2021 BioDelivery Sciences International, Inc.  All rights reserved.

    Contact:

    Terry Coelho

    Chief Financial Officer

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989



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  4. RALEIGH, N.C., Nov. 20, 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 Jeff Bailey, Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will participate in a fireside chat and 1x1 investor meetings at the Piper Sandler 32nd Annual Healthcare Conference.

    The pre-recorded fireside chat will be available for viewing beginning November 23rd through December 3rd by accessing the recording library on the Piper Sandler conference site. BDSI will be hosting 1x1 investor meetings on Wednesday, December 2nd and Thursday, December 3rd. Meetings may be requested…

    RALEIGH, N.C., Nov. 20, 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 Jeff Bailey, Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will participate in a fireside chat and 1x1 investor meetings at the Piper Sandler 32nd Annual Healthcare Conference.

    The pre-recorded fireside chat will be available for viewing beginning November 23rd through December 3rd by accessing the recording library on the Piper Sandler conference site. BDSI will be hosting 1x1 investor meetings on Wednesday, December 2nd and Thursday, December 3rd. Meetings may be requested exclusively via Piper Sandler.

    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

     



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  5. RALEIGH, N.C., Nov. 11, 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, Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will participate in the virtual Southwest IDEAS Investor Conference on November 18, 2020. BDSI's presentation will be webcasted and is scheduled to be available at 7:00 am CST on November 18. The presentation can be accessed through the Southwest IDEAS conference portal for registered participants, in the investor relations section of the Company's website: www.bdsi.com, and on the IDEAS conference website: www.IDEASconferences.com

    RALEIGH, N.C., Nov. 11, 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, Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will participate in the virtual Southwest IDEAS Investor Conference on November 18, 2020. BDSI's presentation will be webcasted and is scheduled to be available at 7:00 am CST on November 18. The presentation can be accessed through the Southwest IDEAS conference portal for registered participants, in the investor relations section of the Company's website: www.bdsi.com, and on the IDEAS conference website: www.IDEASconferences.com.

    About IDEAS Investor Conferences

    The mission of the IDEAS Conferences is to provide independent regional venues for quality companies to present their investment merits to an influential audience of investment professionals. Unlike traditional bank-sponsored events, IDEAS Investor Conferences are "Sponsored BY the Buyside FOR the Buyside" and for the benefit of regional investment communities.

    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

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  6. Total Company Net Revenue Increased 30% versus Prior Year Reaching a Record $39.4 Million

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

    RALEIGH, N.C., Nov. 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 third quarter ended September 30, 2020, as well as the following operational and performance highlights.

    Key Business Highlights

    • Total Company net revenue for the third quarter increased by 30% versus the prior year period to $39.4 million. This growth was driven by BELBUCA® net sales of $34.8 million, an increase of…

    Total Company Net Revenue Increased 30% versus Prior Year Reaching a Record $39.4 Million

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

    RALEIGH, N.C., Nov. 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 third quarter ended September 30, 2020, as well as the following operational and performance highlights.

    Key Business Highlights

    • Total Company net revenue for the third quarter increased by 30% versus the prior year period to $39.4 million. This growth was driven by BELBUCA® net sales of $34.8 million, an increase of 31% versus the prior year period, and Symproic® net sales of $3.5 million, an increase of 59% compared to the third quarter of 2019.
    • BELBUCA reached all-time high prescription volume and market share, with total BELBUCA prescriptions of more than 114,500 during the third quarter, representing year-over-year prescription volume growth of 25%.
    • Symproic reached all-time high prescription volume and market share, with total Symproic prescriptions of more than 18,100 in the third quarter, representing growth of 12% versus the prior year.
    • Achieved significant growth to $9.4 million of GAAP Net Income and an attractive 34% EBITDA Margin in the third quarter. 
    • Jeff Bailey appointed as Chief Executive Officer (CEO) after serving as interim CEO since May 2020.



    • Announced that its Board of Directors authorized the repurchase of up to $25.0 million of the Company's shares of common stock. The Company plans to utilize existing cash on hand to fund the share repurchase program.             

    "Our commercial execution during the third quarter has been extremely impactful as evidenced by strong prescription trends for both BELBUCA and Symproic, which have continued in October," stated Jeff Bailey, CEO of BDSI. "I am proud to permanently join the talented BDSI team and very confident in our ability to execute on our vision to deliver innovative products to patients while maximizing shareholder value."

    Third Quarter 2020 Financial Results

    Total Company Net Revenue for the third quarter of 2020 was a record $39.4 million, an increase of 30% compared to $30.3 million in the third quarter of 2019, and an increase of 8% compared to $36.6 million in the second quarter of 2020.

    BELBUCA Net Sales for the third quarter of 2020 were $34.8 million, an increase of 31% compared to $26.5 million in the third quarter of 2019, and an increase of 7% compared to $32.3 million in the second quarter of 2020. While BELBUCA gross to net deductions increased in the third quarter as anticipated, primarily due to typical increases seen for Medicare coverage gap, along with increased Medicaid costs, those increases were favorably impacted by updates to our channel estimates reflected in the third quarter of 2020.

    Symproic Net Sales for the third quarter were $3.5 million, an increase of 59% compared to $2.2 million in the third quarter of 2019, and an increase of 1% compared to $3.4 million in the second quarter of 2020.

    BUNAVAIL Net Revenue for the third quarter was $0.6 million, reflecting the release of a portion of the returns reserves taken at the time discontinuation was announced. In March, the Company announced the discontinuation of marketing of BUNAVAIL.

    Total Operating Expenses for the third quarter of 2020 were $22.5 million, compared to $23.4 million in the third quarter of 2019 and $28.2 million in the second quarter of 2020.

    GAAP Net Income for the third quarter of 2020 was $9.4 million, or $0.09 per share, compared to GAAP net income of $0.4 million, or $0.00 per share, in the third quarter of 2019 and GAAP net income of $1.2 million, or $0.01 per share, for the second quarter of 2020.

    EBITDA for the third quarter of 2020 was $13.4 million, or 34% of net sales, compared to $3.5 million or 11.6% of net sales in the third quarter of 2019 and $5.1 million or 13.9% of net sales in the second quarter of 2020.

    Non-GAAP Net Income for the third quarter of 2020 was $12.7 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets. This reflects an increase of $9.2 million as compared to non-GAAP net income of $3.5 million in the third quarter of 2019, excluding the same items, and an increase of $3.1 million compared to  non-GAAP net income of $9.6 million in the second quarter of 2020, excluding stock-based compensation, non-cash amortization of intangible assets, the non-recurring financial impact of the BUNAVAIL discontinuation and the one-time expenses related to the CEO transition incurred in the second quarter.

    Cash Position: As of September 30, 2020, cash and cash equivalents were approximately $100.2 million, compared to $63.9 million at December 31, 2019, reflecting the generation of  positive operating cash flow of $9.0 million and $14.0 million in the three and nine month periods, respectively,  through September 30th.   The total cash flow generation year to date of $36.3 million includes the operating cash generation of $14.0 million, $2.8 million in proceeds from the exercise of options, and $19.6 million of net proceeds from increasing our existing credit facility.

    "The continuing market performance of both BELBUCA and Symproic, together with our strong profitability and balance sheet, and most importantly the commitment of our team to serving patients, position BDSI well to continue to drive long-term shareholder value," stated Jeff Bailey.  

    Conference Call & Webcast Details

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

    Date: Thursday, November 5, 2020
    Time:8:30 AM Eastern Time
    Domestic:877-407-0789
    International:201-689-8562
    Conference ID:13710272
    Webcast:http://public.viavid.com/index.php?id=141502

    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 the 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)

     September 30,

    2020
     December 31,

    2019
    ASSETS   
    Current assets:   
    Cash and cash equivalents$100,177   $63,888  
    Accounts receivable, net43,830   38,790  
    Inventory, net18,887   11,312  
    Prepaid expenses and other current assets5,754   3,769  
    Total current assets168,648   117,759  
    Property and equipment, net1,485   2,075  
    Goodwill2,715   2,715  
    License and distribution rights, net55,109   60,309  
    Other intangible assets, net   47  
    Total assets$227,957   $182,905  
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable and accrued liabilities$53,409   $53,993  
    Total current liabilities53,409   53,993  
    Notes payable, net78,363   58,568  
    Other long-term liabilities300   580  
    Total liabilities132,072   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 September 30, 2020 and December 31, 2019, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 and 618 shares outstanding at September 30, 2020 and December 31, 2019, respectively.   2  
    Common Stock, $0.001 par value; 235,000,000 and 175,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 101,126,452 and 96,189,074 shares issued; 101,110,961 and 96,173,583 shares outstanding at September 30, 2020 and December 31, 2019, respectively.100   96  
    Additional paid-in capital446,910   436,306  
    Treasury stock, at cost, 15,491 shares as of September 30, 2020 and December 31, 2019.(47)  (47) 
    Accumulated deficit(351,078)  (366,593) 
    Total stockholders' equity95,885   69,764  
    Total liabilities and stockholders' equity$227,957   $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 September 30, Nine months ended September 30,
     2020 2019 2020 2019
    Revenues:       
    Product sales$38,785   $29,623   $112,946   $77,438  
    Product royalty revenues658   683   1,358   2,154  
    Contract revenues         160  
    Total Revenues:39,443   30,306   114,304   79,752  
    Cost of sales5,376   5,350   16,371   14,325  
    Expenses:       
    Selling, general and administrative22,461   23,360   77,408   62,304  
    Total Expenses:22,461   23,360   77,408   62,304  
    Income from operations11,606   1,596   20,525   3,123  
    Interest expense, net(2,010)  (1,234)  (4,997)  (17,732) 
    Other (expense)/income, net(2)  (3)  6   5  
    Income/(loss) before income taxes$9,594   $359   $15,534   $(14,604) 
    Income tax provision(211)  (5)  (19)  (5) 
    Net income/(loss) attributable to common stockholders$9,383   $354   $15,515   $(14,609) 
    Basic       
    Weighted average common stock shares outstanding101,031,317   89,649,922   99,377,748   81,612,112  
    Basic earnings/(loss) per share$0.09   $   $0.16   $(0.18) 
    Diluted       
    Weighted average common stock shares outstanding105,783,568   105,138,894   104,836,493   81,612,112  
    Diluted earnings/(loss) per share$0.09   $   $0.15   $(0.18) 





    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (U.S. DOLLARS, IN THOUSANDS)

    (Unaudited)

     Nine months ended September 30, 2020
     2020 2019
    Operating activities:   
    Net income/(loss)$15,515   $(14,609) 
    Adjustments to reconcile net income/(loss) to net cash flows from operating activities   
    Depreciation and amortization467   253  
    Accretion of debt discount and loan costs231   11,441  
    Amortization of intangible assets5,248   5,084  
    Provision for inventory obsolescence(297)  57  
    Stock-based compensation expense7,845   3,978  
    Changes in assets and liabilities:   
    Accounts receivable(5,040)  (19,795) 
    Inventories(7,278)  (5,416) 
    Prepaid expenses and other assets(1,985)  (1,686) 
    Accounts payable and accrued liabilities(701)  14,844  
    Taxes payable(40)    
    Net cash flows provided by/(used in) operating activities13,965   (5,849) 
    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 options2,761   1,193  
    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 activities22,324   38,643  
    Net change in cash and cash equivalents36,289   12,041  
    Cash and cash equivalents at beginning of period63,888   43,822  
    Cash and cash equivalents at end of period$100,177   $55,863  





    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

    RECONCILIATION OF NON-GAAP METRICS

    (U.S. DOLLARS, IN THOUSANDS)

    (Unaudited)

      Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
    Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) 20202019 20202019
    GAAP net income/(loss) $9,383 $354  $15,515 $(14,609) 
    Add back/(subtract):      
    Income tax provision 211 4  19 4  
    Net interest expense 2,012 1,237  4,991 17,727  
    Depreciation and amortization 1,754 1,904  5,715 5,259  
    EBITDA $13,360 $3,499  $26,240 $8,381  
    Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)      
    GAAP net income/(loss) 9,383 354  15,515 (14,609) 
    Non-GAAP adjustments:      
    Stock-based compensation expense 1,473 1,267  4,424 3,978  
    Amortization of intangible assets 1,734 1,898  5,248 5,084  
    Amortization of warrant discount     448  
    Non-recurring financial impact of debt refinance     11,866  
    Non-recurring financial impact of CEO transition 67   5,078   
    Non-recurring financial impact of BUNAVAIL discontinuation    295   
    Non-GAAP net income/(loss) $12,657 $3,519  $30,560 $6,767  

     

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  7. RALEIGH, N.C., Nov. 04, 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 its Board of Directors has authorized the repurchase of up to $25 million of the Company's shares of common stock.

    "This share repurchase program reflects our confidence in the long-term outlook for the Company, including our ability to generate strong cash flow," said Jeff Bailey, Chief Executive Officer of BioDelivery Sciences International. "Importantly, we remain focused on balancing our disciplined approach to capital allocation against growth opportunities available to BDSI, including continuing…

    RALEIGH, N.C., Nov. 04, 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 its Board of Directors has authorized the repurchase of up to $25 million of the Company's shares of common stock.

    "This share repurchase program reflects our confidence in the long-term outlook for the Company, including our ability to generate strong cash flow," said Jeff Bailey, Chief Executive Officer of BioDelivery Sciences International. "Importantly, we remain focused on balancing our disciplined approach to capital allocation against growth opportunities available to BDSI, including continuing to invest in the organic growth of our portfolio along with pursuing strategic acquisitions that will continue to drive long-term shareholder value."

    The Company expects to make repurchases at the discretion of management from time to time in the open market, depending on market conditions, or through privately negotiated transactions. The timing and amount of any shares purchased on the open market will be determined based on the Company's evaluation of market conditions, share price and other factors. The Company plans to utilize existing cash on hand to fund the share repurchase program.

    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 Company's ability to repurchase shares and to generate cash flow) may differ 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.

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

    Contact:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Primary Logo

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  8. RALEIGH, N.C., Nov. 04, 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 its Board of Directors has appointed Jeff Bailey as permanent Chief Executive Officer (CEO), effective November 4, 2020. Jeff had previously been appointed as interim CEO in May 2020 while continuing to serve on the Board of Directors.

    "Jeff has been extremely effective in managing the Company during this challenging period and continuously driving growth, and we are very pleased he has agreed to accept the role of permanent CEO," stated Peter Greenleaf, Chairman of the Board of Directors of…

    RALEIGH, N.C., Nov. 04, 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 its Board of Directors has appointed Jeff Bailey as permanent Chief Executive Officer (CEO), effective November 4, 2020. Jeff had previously been appointed as interim CEO in May 2020 while continuing to serve on the Board of Directors.

    "Jeff has been extremely effective in managing the Company during this challenging period and continuously driving growth, and we are very pleased he has agreed to accept the role of permanent CEO," stated Peter Greenleaf, Chairman of the Board of Directors of BDSI. "I am confident that Jeff has the strategic vision and expertise in the pharmaceutical industry to guide BDSI through its next phase. The Board and I are delighted to appoint Jeff as BDSI's CEO."

    Mr. Bailey has an accomplished record in leading both public and private healthcare companies where he has leveraged his diverse leadership experiences in various functional areas including commercial, supply chain and business development, as well as in-licensing and transactions. His experiences include a 20+ year career at Johnson & Johnson/Janssen Pharmaceuticals as well as a tenure as Operating Unit President at Novartis Pharmaceuticals, Chief Commercial Officer at King Pharmaceuticals, Chief Operating Officer at Fougera Pharmaceuticals, and Chairman and CEO of Neurovance. Mr. Bailey also served as President and CEO of Lantheus Medical Imaging, taking the company public in 2015. Most recently, he was the CEO of IlluminOss Medical, Inc., which was acquired in May 2020.

    "Over the last six months, I have been able to see our very talented team at BDSI in action," stated Jeff Bailey. "When you combine our exceptional people with high-quality differentiated products and our strong balance sheet, we are really poised to deliver strong results by executing on our corporate strategy and expanding our growth. I look forward to being part of the exciting future and driving long term shareholder value."

    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, BDSI's continued growth and expansion) 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.

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

    Contact:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Primary Logo

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  9. RALEIGH, N.C., Oct. 23, 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 third quarter 2020 financial results before the open of the U.S. financial markets on Thursday, November 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: Thursday, November 5, 2020
    Time:8:30 AM Eastern Time
    Domestic:877-407-0789
    International:201-689-8562
    Conference ID:13710272
    Webcast:http://public.viavid.com/index.php?id=141502

    RALEIGH, N.C., Oct. 23, 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 third quarter 2020 financial results before the open of the U.S. financial markets on Thursday, November 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: Thursday, November 5, 2020
    Time:8:30 AM Eastern Time
    Domestic:877-407-0789
    International:201-689-8562
    Conference ID:13710272
    Webcast:http://public.viavid.com/index.php?id=141502

    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

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  10. 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

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  11. 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

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  12. 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 

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  13. 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

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  14. 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
     

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  15. RALEIGH, N.C., May 11, 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 A. Bailey, a member of the Company's Board of Directors, has been named Interim Chief Executive Officer (CEO), effective today. Mr. Bailey succeeds Herm Cukier as CEO.

    "On behalf of the Board and our entire Company, I am excited that Jeff Bailey has agreed to serve as Interim CEO," stated Peter Greenleaf, Chairman of the Board of Directors of BDSI. "The Board thanks Herm Cukier for his leadership during a transformative time in the Company's history, and we wish him the best in the future…

    RALEIGH, N.C., May 11, 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 A. Bailey, a member of the Company's Board of Directors, has been named Interim Chief Executive Officer (CEO), effective today. Mr. Bailey succeeds Herm Cukier as CEO.

    "On behalf of the Board and our entire Company, I am excited that Jeff Bailey has agreed to serve as Interim CEO," stated Peter Greenleaf, Chairman of the Board of Directors of BDSI. "The Board thanks Herm Cukier for his leadership during a transformative time in the Company's history, and we wish him the best in the future."

    "Jeff Bailey has a terrific track record of leading organizations and delivering shareholder value," stated Kevin Kotler, Chair of the Nominating & Corporate Governance Committee and founder of Broadfin Capital.  "We look forward to his help in refining and driving our long-term strategic plan."

    Mr. Bailey has an accomplished record in leading both public and private healthcare companies where he has leveraged his diverse leadership experiences in various functional areas including commercial, supply chain and business development, as well as in-licensing and transactions.  His experiences include a 20+ year career at Johnson & Johnson/Janssen Pharmaceutica as well as a tenure as Operating Unit President at Novartis Pharmaceuticals, Chief Commercial Officer at King Pharmaceuticals, Chief Operating Officer at Fougera Pharmaceuticals, and Chairman and CEO of Neurovance.  Mr. Bailey also served as President and CEO of Lantheus Medical Imaging, Inc, taking the company public in 2015.  Most recently, he was the CEO of IlluminOss Medical, Inc, which was acquired last month.

    "I look forward to working with the BDSI team in taking the Company to the next level," stated Jeff Bailey.  "BDSI has therapeutically differentiated products that really make a difference in patients' lives.  We have so much opportunity in front of us."

    Mr. Bailey has served as Chairman of Aileron Therapeutics since March 2018 and as a Board Member of Madison Vaccines, a privately held biopharmaceutical company, since October 2017.   Mr. Bailey received a Bachelor of Science Degree from Rutgers University.

    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
    (919) 551-5281
    e-mail:

     

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  16. First Quarter Total Company Net Sales Increased 94% versus Prior Year to $38.3 Million

    First Quarter BELBUCA® Net Sales Increased 79% versus Prior Year to $33.5 Million

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

    RALEIGH, N.C., May 07, 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 first quarter ended March 31, 2020, as well as the following operational and performance highlights.

    Key Business Highlights

    • Total Company net revenue for the first quarter increased by 94% versus the prior year period to a record level of $38.3…

    First Quarter Total Company Net Sales Increased 94% versus Prior Year to $38.3 Million

    First Quarter BELBUCA® Net Sales Increased 79% versus Prior Year to $33.5 Million

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

    RALEIGH, N.C., May 07, 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 first quarter ended March 31, 2020, as well as the following operational and performance highlights.

    Key Business Highlights

    • Total Company net revenue for the first quarter increased by 94% versus the prior year period to a record level of $38.3 million. This growth was driven by BELBUCA sales of $33.5 million, an increase of 79% versus the prior year period, and Symproic® sales of $4.2 million.
    • Total BELBUCA prescriptions reached an all-time high of 99,400 during the first quarter, representing year-over-year prescription volume growth of more than 52%.
    • Total Symproic prescriptions were more than 16,100 in the first quarter, representing growth of 19% versus the prior year period.
    • Achieved record number of unique prescribers during the quarter for both BELBUCA and Symproic.
    • Continued to expand BELBUCA Medicare patient access with the addition of more than two million covered lives, the vast majority of which have preferred access to BELBUCA, through a national PBM.
    • Expanded BELBUCA commercial coverage within two important regional plans representing nearly 900,000 lives that can receive BELBUCA without being required to first fail two CII long-acting opioids.
    • Strong financial position driven by performance and positive cash flow of $6.7 million in the quarter.

    "I am very pleased by the success and momentum we achieved during the first quarter," stated Herm Cukier, CEO of BDSI. "Both BELBUCA and Symproic prescriptions were experiencing considerable growth before the start of the COVID-19 pandemic, helping deliver strong first quarter results. I am also very proud of how the organization rapidly transitioned our efforts to virtual connectivity with our prescribers, ensured continuity of supply, and continued to provide valuable service to patients. While these are unprecedented and uncertain times, I remain very confident in the clinical value of our products and the long-term prospects for the company." 

    First Quarter 2020 Financial Results

    Total Company Net Revenue for the first quarter of 2020 was $38.3 million, an increase of 94% compared to $19.8 million in the first quarter of 2019, and an increase of 21% compared to $31.6 million in the fourth quarter of 2019.

    BELBUCA Net Sales for the first quarter of 2020 were $33.5 million, an increase of 79% compared to $18.7 million in the first quarter of 2019, and an increase of 18% compared to $28.3 million in the fourth quarter of 2019.

    Symproic Net Sales for the first quarter were $4.2 million, an increase of 54% compared to $2.7 million in the fourth quarter of 2019.

    BUNAVAIL Net Sales for the first quarter were $0.1 million compared to $1.1 million in the first quarter of 2019. In March of this year, the Company announced the planned discontinuation of marketing of BUNAVAIL in 2020.

    Total Operating Expenses for the first quarter of 2020 were $26.7 million, compared to $23.8 million in the fourth quarter of 2019 and $17.0 million in the first quarter of 2019.

    GAAP Net Income for the first quarter of 2020 was $5.0 million, or $0.05 per share,  compared to GAAP net loss of $0.7 million, or ($0.01) per share, for the fourth quarter of 2019 and GAAP net loss of $3.8 million, or ($0.05) per share, in the first quarter of 2019.

    EBITDA in the first quarter of 2020 was $7.8 million, or 20% of net sales, compared to $4.1 million in the fourth quarter of 2019 and $0.1 million in the first quarter of 2019.

    Non-GAAP Net Income for the quarter was $8.3 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets.

    Cash Position: As of March 31, 2020, cash and cash equivalents were approximately $70.6 million, compared to $63.9 million in the fourth quarter of 2019, reflecting positive cash flow of $6.7 million in the first quarter of 2020.

    2020 Net Sales Guidance:

    Given the uncertainty surrounding the COVID-19 pandemic, the Company is withdrawing its 2020 BELBUCA and Total Company net sales guidance, previously introduced in November 2019.

    Conference Call & Webcast Details

    BioDelivery Sciences will host a conference call and webcast today, May 7, 2020, at 4:30 p.m. ET to present first quarter 2020 results and to provide a business update.  Dial-in details are as follows:

    Date:  Thursday, May 7, 2020
    Time: 4:30 PM Eastern Time
    Domestic: 800-289-0571
    International: 720-543-0206
    Conference ID: 6176462
    Webcast: http://public.viavid.com/index.php?id=139300

    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.

    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 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, and the financial impact of certain one-time items that are non-recurring, including the impact of the discontinuation of marketing of BUNAVAIL.

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

    Tirth Patel
    Director of Investor Relations
    (919) 582-0294

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
    (Unaudited)

      March 31,
    2020
      December 31,
    2019
    ASSETS      
    Current assets:      
    Cash and cash equivalents $ 70,613     $ 63,888  
    Accounts receivable, net 45,114     38,790  
    Inventory, net 15,003     11,312  
    Prepaid expenses and other current assets 2,600     3,769  
    Total current assets 133,330     117,759  
    Property and equipment, net 1,995     2,075  
    Goodwill 2,715     2,715  
    License and distribution rights, net 58,576     60,309  
    Other intangible assets, net     47  
    Total assets $ 196,616     $ 182,905  
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable and accrued liabilities $ 60,931     $ 53,993  
    Total current liabilities 60,931     53,993  
    Notes payable, net 58,634     58,568  
    Other long-term liabilities 463     580  
    Total liabilities 120,028     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 March 31, 2020 and December 31, 2019, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 and 618 shares outstanding at March 31, 2020 and December 31, 2019, respectively.     2  
    Common Stock, $0.001 par value; 175,000,000 shares authorized at March 31, 2020 and December 31, 2019, respectively; 99,821,408 and 96,189,074 shares issued; 99,805,917 and 96,173,583 shares outstanding at March 31, 2020 and December 31, 2019, respectively. 99     96  
    Additional paid-in capital 438,163     436,306  
    Treasury stock, at cost,15,491 shares, as of March 31, 2020 and December 31, 2019. (47 )   (47 )
    Accumulated deficit (361,627 )   (366,593 )
    Total stockholders' equity 76,588     69,764  
    Total liabilities and stockholders' equity $ 196,616     $ 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
      March 31, 2020   Dec. 31, 2019 March 31, 2019
    Revenues:        
    Product sales $ 37,715     $ 30,450   $ 19,759  
    Product royalty revenues 563       1,187   2  
    Contract revenues         8  
    Total Revenues: 38,278       31,637   19,769  
    Cost of sales 5,560       7,264   4,052  
    Expenses:        
    Selling, general and administrative 26,736       23,759   16,989  
    Total Expenses: 26,736       23,759   16,989  
    Income (loss) from operations 5,982       614   (1,272 )
    Interest expense (1,293 )     (1,308 ) (2,561 )
    Other expense, net (1 )     (1 )  
    Income (loss) before income taxes $ 4,688     $ (695 ) $ (3,833 )
    Income tax benefit 278       (1 )  
    Net income (loss) attributable to common stockholders $ 4,966     $ (696 ) $ (3,833 )
    Basic        
    Weighted average common stock shares outstanding 97,118,267       92,118,497   71,344,831  
    Basic earnings (loss) per share $ 0.05     $ (0.01 ) $ (0.05 )
    Diluted        
    Weighted average common stock shares outstanding 106,965,762       92,118,497   71,344,831  
    Diluted earnings (loss) per share $ 0.05     $ (0.01 ) $ (0.05 )
                         
                         

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    (U.S. DOLLARS, IN THOUSANDS)
    (Unaudited)

       Three months ended
      March 31, 2020   Dec. 31, 2019 March 31, 2019
    Operating activities:        
    Net income (loss) $ 4,966     $ ( 696 ) $ (3,833 )
    Adjustments to reconcile net loss to net cash flows from operating activities        
    Depreciation 21       1,592   85  
    Accretion of debt discount and loan costs 65       67   634  
    Amortization of intangible assets 1,781       1,896   1,289  
    Provision for inventory obsolescence 405       140   149  
    Stock-based compensation expense 1,520       1,438   1,141  
    Changes in assets and liabilities:        
    Accounts receivable (6,324 )     (5,368 ) (2,381 )
    Inventories (4,096 )     (685 ) (2,002 )
    Prepaid expenses and other assets 1,169       1,106   218  
    Accounts payable and accrued liabilities 6,920       17,432   1,814  
    Taxes payable (40 )      
    Net cash flows provided by (used in) operating activities 6,387       16,922   (2,886 )
    Investing activities:        
    Product Acquisitions       (10,011 )  
    Disposal of property and equipment         (79 )
    Net cash flows used in investing activities       (10,011 ) (79 )
    Financing activities:        
    Proceeds from exercise of stock options 338       1,127   472  
    Debt issuance costs       (13 )  
    Net cash flows provided by financing activities 338       1,114   472  
    Net change in cash and cash equivalents 6,725       8,025   (2,493 )
    Cash and cash equivalents at beginning of period 63,888       55,863   43,822  
    Cash and cash equivalents at end of period $ 70,613      $   63,888   $ 41,329   
                         

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES 
    RECONCILIATION OF NON-GAAP METRICS 
    (U.S. DOLLARS, IN THOUSANDS) 
    (Unaudited)

    Reconciliations of non-GAAP metrics to most directly comparable U.S. GAAP financial measures:

    The following tables reconcile net income/(loss)earnings and computations (in thousands) under GAAP to a Non-GAAP basis.

      Three Months Ended
    Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) March 31, 2020
    Dec. 31, 2019 
    March 31, 2019
    GAAP net income/(loss) $ 4,966   $ (696 ) $ (3,833 )
    Add back:      
    Provision for income taxes (278 )   1    
    Net interest expense 1,294     1,308   2,561  
    Depreciation and amortization 1,802     3,491   1,375  
    EBITDA $ 7,784   $ 4,104   $ 103  
    Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)      
    GAAP net income/(loss) 4,966     (696 ) (3,833 )
    Non-GAAP adjustments:      
    Stock-based compensation expense 1,520     1,438   1,142  
    Amortization of intangible assets 1,781     1,899   1,289  
    Amortization of warrant discount       269  
    Non-recurring financial impact – BUNAVAIL discontinuation     3,750    
    Non-GAAP net income/(loss) $ 8,267   $ 6,391   $ (1,133 )
                       

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  17. Completes concurrent financing of ~$22 million led by Orbimed Advisors, LLC

    Lead program, a proprietary long-acting GLP-1 receptor agonist, starting Phase 2 trial for Short Bowel Syndrome (SBS), an underserved, orphan condition

    Continued Phase 3 trial of larazotide; first and only drug for celiac disease

    Multiple inflection points with the start of a Phase 2 SBS trial in 2H 2020 and top-line results in 2021

    RALEIGH, NC / ACCESSWIRE / April 30, 2020 / Innovate Biopharmaceuticals, Inc. (NASDAQ:INNT), today announced the completion of its previously announced merger with privately-held RDD Pharma, Ltd. Following the completion of the merger, Innovate is changing its name to 9 Meters Biopharma, Inc. ("9 Meters" or the "Company") and will continue trading…

    Completes concurrent financing of ~$22 million led by Orbimed Advisors, LLC

    Lead program, a proprietary long-acting GLP-1 receptor agonist, starting Phase 2 trial for Short Bowel Syndrome (SBS), an underserved, orphan condition

    Continued Phase 3 trial of larazotide; first and only drug for celiac disease

    Multiple inflection points with the start of a Phase 2 SBS trial in 2H 2020 and top-line results in 2021

    RALEIGH, NC / ACCESSWIRE / April 30, 2020 / Innovate Biopharmaceuticals, Inc. (NASDAQ:INNT), today announced the completion of its previously announced merger with privately-held RDD Pharma, Ltd. Following the completion of the merger, Innovate is changing its name to 9 Meters Biopharma, Inc. ("9 Meters" or the "Company") and will continue trading on NASDAQ with the ticker symbol NMTR, effective May 4, 2020.

    In addition, the Company announced the signing of approximately $22 million in new financing, led by Orbimed Advisors, LLC, and the signing of the previously announced merger with Naia Rare Diseases, a company developing a proprietary long acting GLP-1 for the treatment of Short Bowel Syndrome. In the financing the Company will issue units consisting of preferred stock and warrants, at a price of $0.5894 per unit, on an as converted to common stock basis. The combined Company will be focused on developing urgently needed treatments for patients with rare, orphan diseases and unmet needs in GI. The combined Company will have two late-stage lead assets funded to their next key inflection points, which include the initiation of a Phase 2 trial in short bowel syndrome in 2H 2020 with top-line results expected in 2021, and the receipt of top-line results for an ongoing Phase 3 trial in celiac disease in 2021.

    "9 Meters Biopharma plans to deliver meaningful science and treatments for patients and providers which will translate into multiple inflection points for investors. This includes a novel approach with the first and only long-acting GLP-1 receptor agonist for the treatment of short bowel syndrome, and the first-ever drug in a Phase 3 trial for celiac disease," said John Temperato, President & Chief Executive Officer of 9 Meters.

    Mark Pimentel, M.D. FRCPC, Director of the Gastrointestinal Motility Program and Laboratory and Executive Director of the Medically Associated Science and Technology (MAST) program at Cedars-Sinai Medical Center added, "People living with short bowel syndrome have unmet motility needs and this long-acting GLP-1 agonist is one of the only compounds in development to directly address these by potentially allowing for elimination of parenteral nutrition and an improvement in quality of life."

    Benjamin Lebwohl, MD, MS, Louis and Gloria Flanzer Scholar at the Columbia University Medical Center and Director of Clinical Research at The Celiac Disease Center at Columbia University commented, "It has become abundantly clear that there has been a rising incidence of celiac disease and an increasing recognition of the difficulties of strict gluten avoidance with an impact on long-term outcomes in people with this condition, affecting health and quality of life. Though the gluten-free diet is effective, its challenges and limitations pose a significant unmet need in this population."

    The Board of Directors has extensive industry experience and includes Mark Sirgo, PharmD former CEO of BioDelivery Sciences (NASDAQ:BDSI) and board member of Salix Pharmaceuticals, as Chairman of the Board, Nissim Darvish, M.D., Ph.D., Senior Managing Director of OrbiMed Advisors, Lorin Johnson, Ph.D., founder of Salix Pharmaceuticals and Sandeep Laumas, M.D., former Chairman of Innovate.

    9 Meters management team is composed of industry veterans who bring an established track record of in-licensing, developing and commercializing multi-billion-dollar assets in gastroenterology. The executive team is led by John Temperato, President & Chief Executive Officer and member of the Board of Directors, and also includes Edward J. Sitar, Chief Financial Officer, Patrick Griffin, M.D. FACP, Chief Medical Officer, Nir Barak M.D., Senior Vice President of Clinical Affairs and Sireesh Appajosyula, PharmD, Senior Vice President of Corporate Development & Operations. The Company will be headquartered in Raleigh, NC.

    9 Meters BioPharma will host its first virtual "R&D Day" for analysts and investors from 1:00 pm to 2:30 pm EDT on May 13, 2020. The virtual R&D Day will include presentations from John Temperato, CEO, Mark Pimentel, M.D. FRCPC and Benjamin Lebwohl, M.D., M.S. with a focus on the Company's clinical development pipeline. The webcast will be available under "Events & Presentations" in the Investors section of the 9 Meters website www.9meters.com.

    William Blair & Company, L.L.C. acted as sole lead placement agent for the concurrent capital raise.

    GP Nurmenkari, Inc., National Securities, Westpark Capital, and Wynston Hill Capital acted as co-placement agents in connection with the concurrent financing. Sheppard, Mullin, Richter & Hampton LLP and Agmon & Co. Rosenberg Hacohen & Co. served as legal counsel to Innovate. Wyrick Robbins Yates & Ponton LLP and Shibolet & Co. served as legal counsel to RDD.

    Conference Call and Webcast
    Management will host a conference call on Monday, May 4th at 08:30 AM EDT for investors regarding this announcement with details as follows:

    Conference Call and Webcast Details:
    Date: May 4, 2020
    Time: 08:30 AM EDT
    Toll-free: 877-407-9716
    International: 201-493-6779
    Webcast URL: http://public.viavid.com/index.php?id=139683

    The archived webcast will be available on the Investors section of the 9 Meters website.

    About 9 Meters Biopharma

    9 Meters Biopharma, Inc. is a rare, orphan and unmet needs focused GI company. The Company is advancing NM-002, a proprietary long-acting GLP-1 agonist into Phase 2 trial for Short Bowel Syndrome (SBS), a rare, orphan disease, as well as larazotide, a Phase 3 tight junction regulator being evaluated for patient-reported symptom improvement in non-responsive celiac disease.

    For more information, please visit www.9meters.com.

    Forward-looking Statements

    This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, the potential effects of the ongoing coronavirus outbreak and related mitigation efforts on the Company's clinical, financial and operational activities; the Company's continued listing on Nasdaq; expectations regarding future financings; the future operations of the Company; the nature, strategy and focus of the Company; the development and commercial potential and potential benefits of any product candidates of the Company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; the Company having sufficient resources to advance its pipeline; and any other statements that are not historical fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) uncertainties associated with the clinical development and regulatory approval of product candidates; (ii) risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) the the impact of COVID-19 on our operations, clinical trials or proposed merger and future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the proposed Merger and the Naia acquisition, including with respect to future financial and operating results. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled "Risk Factors" in Innovate Biopharmaeuticals. Inc. Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings that Innovate has made and future filings the Company will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. The company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    Corporate contact

    Edward J. Sitar
    Chief Financial Officer
    9 Meters BioPharma, Inc.

    www.9meters.com

    Media contact

    Amy Jobe, Ph.D.
    LifeSci Communications, LLC

    315-879-8192

    Investor contact

    Corey Davis, PhD
    LifeSci Advisors, LLC

    212-915-2577

    SOURCE: Innovate Biopharmaeuticals. Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/587899/9-Meters-Biopharma-a-Rare-Orphan-and-Unmet-Needs-GI-Focused-Company-is-Created-with-the-Transformative-Merger-Between-Innovate-Biopharmaceuticals-and-RDD-Pharma

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  18. RALEIGH, N.C., April 28, 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 first quarter 2020 financial results after the close of the U.S. financial markets on Thursday, May 7, 2020. The Company will host a conference call and webcast at 4:30 PM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date:  Thursday, May 7, 2020
    Time: 4:30 PM Eastern Time
    Domestic: 800-289-0571
    International: 720-543-0206
    Conference ID: 6176462
    Webcast: http://public.viavid.com/index.php?id=139300

    RALEIGH, N.C., April 28, 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 first quarter 2020 financial results after the close of the U.S. financial markets on Thursday, May 7, 2020. The Company will host a conference call and webcast at 4:30 PM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date:  Thursday, May 7, 2020
    Time: 4:30 PM Eastern Time
    Domestic: 800-289-0571
    International: 720-543-0206
    Conference ID: 6176462
    Webcast: http://public.viavid.com/index.php?id=139300

    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:
    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294

    Primary Logo

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  19. Full-Year Total Company Net Sales Increased 100% versus Prior Year to $111.4 Million

    Full-Year BELBUCA® Net Sales Increased 112% versus Prior Year to $97.5 Million

    Fourth Quarter Total Company Net Sales Increased 75% versus Prior Year to $31.6 Million

    Fourth Quarter BELBUCA® Net Sales Increased 78% versus Prior Year to $28.3 Million

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

    RALEIGH, N.C., March 12, 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 fourth quarter and full-year ended December 31, 2019, as well as the following…

    Full-Year Total Company Net Sales Increased 100% versus Prior Year to $111.4 Million

    Full-Year BELBUCA® Net Sales Increased 112% versus Prior Year to $97.5 Million

    Fourth Quarter Total Company Net Sales Increased 75% versus Prior Year to $31.6 Million

    Fourth Quarter BELBUCA® Net Sales Increased 78% versus Prior Year to $28.3 Million

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

    RALEIGH, N.C., March 12, 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 fourth quarter and full-year ended December 31, 2019, as well as the following operational and performance highlights.

    Key Business Highlights

    • Total Company full-year net sales of $111.4 million delivered growth of 100% versus 2018 and was driven by BELBUCA® (buprenorphine buccal film), CIII net sales of $97.5 million, an increase of 112% compared to 2018, and the addition of Symproic® (naldemedine) tablets 0.2mg to the commercial portfolio, which delivered $8.1 million net sales in 2019.
    • Total Company net revenue for the fourth quarter increased by 75% versus the prior year period to a new all-time high of $31.6 million. This growth was driven by BELBUCA sales of $28.3 million, an increase of 78% versus the prior year period, and the addition of Symproic to the commercial portfolio.
    • Total BELBUCA prescriptions of more than 96,000 for the fourth quarter were the highest ever for any three-month period, representing year-over-year prescription volume growth of more than 70% in the quarter.
    • Total Symproic prescriptions reached an all-time high of 16,555 in the fourth quarter, representing more than 36% growth versus the prior year period.
    • Achieved record number of unique prescribers during the quarter for both BELBUCA and Symproic.
    • In addition, as previously released, the Company recently presented the positive results from the BELBUCA Phase I respiratory drive study at the American Academy of Pain Medicine's (AAPM) 36th Annual Meeting.

    "I am very pleased by the continued strong execution during the fourth quarter, culminating in a very successful and transformative year for the Company in 2019," stated Herm Cukier, CEO of BDSI. "The continued growth of BELBUCA and Symproic, in addition to the commercial and scientific plans we have developed, position us for long-term sustained success.  We continue to monitor the COVID-19 pandemic for any potential impact which may arise in this rapidly evolving situation, and remain focused on bringing important clinical value to patients." 

    Fourth Quarter 2019 Financial Results

    Total Company Net Revenue for the fourth quarter of 2019 was $31.6 million, an increase of 75% compared to $18.0 million in the fourth quarter of 2018, and an increase of 4% compared to $30.3 million in the third quarter of 2019.

    BELBUCA Net Sales for the fourth quarter of 2019 were $28.3 million, an increase of 78% compared to $15.9 million in the fourth quarter of 2018, and an increase of 7% compared to $26.5 million in the third quarter of 2019.

    Symproic Net Sales for the fourth quarter were $2.7 million, an increase of 25% compared to $2.2 million in the third quarter of 2019.

    BUNAVAIL Net Sales for the fourth quarter were ($0.5) million, a reduction of 141.7% compared to $1.2 million in the fourth quarter of 2018.  Net sales for the fourth quarter of 2019 reflect $2.3 million of one-time additional revenue related reserves in connection with the March 2020 announcement of the discontinuation of marketing of BUNAVAIL.

    Product Royalty Revenue for the fourth quarter was $1.2 million, an increase of $0.2 million compared to $1.0 million in the fourth quarter of 2018 and an increase of $0.5 million compared to the third quarter of 2019.

    Total Operating Expenses for the fourth quarter of 2019 were $23.8 million, compared to $23.4 million in the third quarter of 2019 and $18.5 million in the fourth quarter of 2018.

    GAAP Net Loss for the fourth quarter of 2019 was $0.7 million compared to GAAP net income of $0.4 million for the third quarter of 2019 and GAAP net loss of $7.0 million in the fourth quarter of 2018.

    EBITDA in the fourth quarter of 2019 was $4.1 million, or 13.0% of net sales, compared to $3.5 million in the third quarter of 2019 and ($3.0) million in the fourth quarter of 2018. 

    Non-GAAP Net Income for the quarter was $6.4 million and reflects GAAP net income excluding stock-based compensation, non-cash amortization of intangible assets, and the non-recurring financial impact of $3.8 million related to the discontinuation of marketing of BUNAVAIL.

    Full-Year 2019 Financial Results

    Total Net Revenue for full-year 2019 was $111.4 million, an increase of 100% compared to $55.6 million for full-year 2018.

    BELBUCA Net Sales for full-year 2019 were $97.5 million, an increase of 112% compared to $46.0 million for full-year 2018.

    Symproic Net Sales for full-year 2019 were $8.1 million, reflecting three quarters of sales during 2019.

    BUNAVAIL Net Sales for full-year 2019 were $2.3 million, a reduction of 57.4% compared to $5.4 million for full-year 2018.

    Product Royalty Revenue for full-year 2019 was $3.5 million, compared to $4.2 million for full-year 2018.

    Total Operating Expenses for full-year 2019 were $86.1 million, compared to $63.5 million for full-year 2018.

    GAAP Net Loss for full-year 2019 was $15.3 million compared to GAAP net loss of $33.9 million for full-year 2018.

    EBITDA for full-year of 2019 was $12.5 million, or 11.2% of net sales compared to ($17.5) million, or (31.4)% of net sales for full-year 2018. 

    Non-GAAP Net Income for full-year 2019 was $13.2 million and reflects GAAP net income excluding stock-based compensation, non-cash amortization of intangible assets and certain warrant discount costs, one-time expenses related to our  debt refinancing in May 2019, and the non-recurring financial impact related to the discontinuation of the marketing of BUNAVAIL.

    Cash Position: As of December 31, 2019, cash and cash equivalents were approximately $63.9 million, compared to cash and cash equivalents of $43.8 million as of December 31, 2018, and $55.9 million in the third quarter of 2019, reflecting positive cash flow of $8.0 million in the fourth quarter of 2019, and $20.1 million for full-year 2019.

    Conference Call & Webcast Details

    BioDelivery Sciences will host a conference call and webcast today, March 12, 2020, at 4:30 p.m. ET to present fourth quarter 2019 results and to provide a business update.  Dial-in details are as follows:

    Date:  Thursday, March 12, 2020
    Time: 4:30 PM EST
    Domestic: 877-407-0789
    International: 201-689-8562
    Conference ID: 13699178
    Webcast: http://public.viavid.com/index.php?id=138131

    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.

    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 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, and the financial impact of certain one-time items that are non-recurring, including our debt refinancing in May 2019 and the discontinuation of marketing of BUNAVAIL.

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

    Tirth Patel
    Director of Investor Relations
    (919) 582-0294


    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONSOLIDATED BALANCE SHEETS
    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

      December 31,
      2019   2018
    ASSETS      
    Current assets:      
    Cash $ 63,888       $ 43,822    
    Accounts receivable, net 38,790       13,627    
    Inventory, net 11,312       5,406    
    Prepaid expenses and other current assets 3,769       3,188    
    Total current assets 117,759       66,043    
    Property and equipment, net 2,075       3,072    
    Goodwill 2,715       2,715    
    License and distribution rights, net 60,309       36,000    
    Other intangible assets, net 47       703    
    Total assets $ 182,905       $ 108,533    
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable and accrued liabilities $ 53,993       $ 21,539    
    Total current liabilities 53,993       21,539    
    Notes payable, net 58,568       51,652    
    Other long-term liabilities 580       5,600    
    Total liabilities 113,141       78,791    
    Commitments and contingencies      
    Stockholders' equity:      
    Preferred Stock, 5,000,000 shares authorized; 2,714,300 shares issued; Series A Non-Voting Convertible Preferred Stock. $0.001 par value, 2,093,155 shares outstanding at both December 31, 2019 and December 31, 2018, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 618 and 3,100 shares outstanding at December 31, 2019 and December 31, 2018 respectively. 2       2    
    Common Stock, $.001 par value; 175,000,000 and 125,000,000 shares authorized at December 31, 2019 and December 31, 2018 respectively;  96,189,074 and 70,793,725 shares issued;96,173,583 and 70,778,234 shares outstanding at December 31, 2019 and December 31, 2018, respectively. 96       71    
    Additional paid-in capital 436,306       381,004    
    Treasury stock, at cost, 15,491 shares (47 )     (47 )  
    Accumulated deficit (366,593 )     (351,288 )  
    Total stockholders' equity 69,764       29,742    
    Total liabilities and stockholders' equity $ 182,905       $ 108,533    



    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

      Year Ended December 31,
      2019   2018   2017
    Revenues:          
    Product sales $ 107,888       $ 51,410       $ 34,922    
    Product royalty revenues 3,341       3,389       5,070    
    Research and development reimbursements             799    
    Contract revenue 160       841       21,194    
    Total revenues 111,389       55,640       61,985    
    Cost of sales 21,590       15,783       19,496    
               
    Expenses:          
    Research and development       4,903       13,040    
    Selling, general and administrative 86,063       58,602       58,869    
    Total expenses 86,063       63,505       71,909    
    Income (loss) from operations 3,736       (23,648 )     (29,420 )  
    Interest expense (19,040 )     (10,192 )     (8,577 )  
    Bargain purchase gain             27,336    
    Other income (expense), net 4       (14 )     (26 )  
    Loss before income taxes (15,300 )     (33,854 )     (10,687 )  
    Income tax (expense) benefit (5 )     (13 )     15,972    
    Net (loss) income (15,305 )     (33,867 )     5,285    
    Beneficial conversion feature of convertible preferred stock       (12,500 )        
    Net (loss) income attributable to common stockholders $ (15,305 )     $ (46,367 )     $ 5,285    
    Basic:          
    Weighted average common stock shares outstanding 83,213,704       63,165,063       55,355,802    
    Basic (loss) earnings per share $ (0.18 )     $ (0.73 )     $ 0.10    
    Diluted:          
    Diluted weighted average common stock shares outstanding 83,213,704       63,165,063       56,402,479    
    Diluted (loss) earnings per share $ (0.18 )     $ (0.73 )     $ 0.09    



    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONSOLIDATED STATEMENTS OF CASH FLOWS
    (U.S. DOLLARS, IN THOUSANDS)

      Year Ended December 31,
      2019   2018   2017
    Operating activities:          
    Net (loss) income $ (15,305 )     $ (33,867 )     $ 5,285    
    Adjustments to reconcile net (loss) income to net cash flows provided by (used in) operating activities          
    Depreciation 1,846       740       693    
    Accretion of debt discount and loan costs 11,508       4,138       2,392    
    Amortization of intangible assets 6,981       5,157       5,425    
    Provision for (recovery from) inventory obsolescence 197       (56 )     243    
    Impairment loss on equipment       78          
    Stock-based compensation expense 5,416       5,941       14,801    
    Deferred income taxes       40       (15,972 )  
    Bargain purchase gain             (27,336 )  
    Changes in assets and liabilities, net of effect of acquisition:          
    Accounts receivable (25,163 )     (4,640 )     (5,884 )  
    Inventories (6,102 )     741       2,448    
    Prepaid expenses and other assets (581 )     422       526    
    Accounts payable and accrued expenses 32,275       (2,807 )     6,644    
    Deferred revenue             (21,716 )  
    Net cash flows provided by (used in) operating activities 11,072       (24,113 )     (32,451 )  
    Investing activities:          
    Product acquisitions (30,685 )     (1,951 )     (5,853 )  
    Acquisitions of equipment (79 )     (112 )     (11 )  
    Net cash flows used in investing activities (30,764 )     (2,063 )     (5,864 )  
    Financing activities:          
    Proceeds from exercise of stock options 2,321       670       439    
    Proceeds from issuance of common stock, less underwriters discount 48,000                
    Proceeds from issuance of Series B preferred stock       50,000          
    Payment on note payable (67,346 )           (30,000 )  
    Proceeds from notes payable 59,987             60,000    
    Equity finance costs (410 )     (1,417 )    
    Payment of deferred financing fees       (450 )     (2,948 )  
    Loss on refinancing of former debt (2,794 )              
    Net cash flows provided by financing activities 39,758       48,803       27,491    
    Net change in cash and cash equivalents 20,066       22,627       (10,824 )  
    Cash and cash equivalents at beginning of year 43,822       21,195       32,019    
    Cash and cash equivalents at end of year $ 63,888       $ 43,822       $ 21,195    



    Reconciliations of non-GAAP metrics to most directly comparable U.S. GAAP financial measures:

    The following tables reconcile net income/(loss)earnings and computations (in thousands) under GAAP to a Non-GAAP basis.

      Year Ended December 31,
    Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) 2019 2018 2017
    GAAP net income/(loss) $ (15,305 )   $ (33,867 )   $ 5,285    
    Add back:      
    Provision for income taxes 5     14     (15,972 )  
    Net interest expense 19,036     10,206     (18,733 )  
    Depreciation and amortization 8,748     6,188     6,119    
    EBITDA $ 12,484     $ (17,459 )   $ (23,301 )  
    Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)      
    GAAP net income/(loss) (15,305 )   (33,867 )   5,285    
    Non-GAAP adjustments:      
    Stock-based compensation expense 5,416     5,941     14,800    
    Amortization of intangible assets 6,981     5,157     5,425    
    Amortization of warrant discount 448     1,076     832    
    Non-recurring financial impact of debt refinance 11,866            
    Non-recurring financial impact of BUNAVAIL discontinuation 3,750     0     0    
    Non-recurring financial impact of bargain purchase gain 0     0     (27,336 )  
    Non-GAAP net income/(loss) $ 13,156     $ (21,693 )   $ (994 )  



      Quarter Ended December 31,
    Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) 2019 2018
    GAAP net income/(loss) $ (696 )   $ (7,008 )  
    Add back:    
    Provision for income taxes 1     (40 )  
    Net interest expense 1,308     2,600    
    Depreciation and amortization 3,491     1,470    
    EBITDA $ 4,104     $ (2,978 )  
    Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)    
    GAAP net income/(loss) (696 )   (7,008 )  
    Non-GAAP adjustments:    
    Stock-based compensation expense 1,438     1,045    
    Amortization of intangible assets 1,899     1,289    
    Amortization of warrant discount     269    
    Non-recurring financial impact of BUNAVAIL discontinuation 3,750        
    Non-GAAP net income/(loss) $ 6,391     $ (21,693 )  

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  20. RALEIGH, N.C., March 09, 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 has appointed Jeffrey A. Bailey to its Board of Directors. Mr. Bailey brings more than 30 years of leadership experience building and leading high-quality pharmaceutical businesses across a diverse variety of important disciplines relevant to the continued growth and evolution of BDSI.  He has an extensive track record of creating significant shareholder value both organically and through business development pathways. 

    "I am very excited to have Jeff join our board of directors," stated Peter…

    RALEIGH, N.C., March 09, 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 has appointed Jeffrey A. Bailey to its Board of Directors. Mr. Bailey brings more than 30 years of leadership experience building and leading high-quality pharmaceutical businesses across a diverse variety of important disciplines relevant to the continued growth and evolution of BDSI.  He has an extensive track record of creating significant shareholder value both organically and through business development pathways. 

    "I am very excited to have Jeff join our board of directors," stated Peter Greenleaf, Chairman of BDSI.  "His extensive experience in both running commercial operations and driving value through corporate transactions will further expand our company's leadership as we continue driving our growth momentum into the future."

    "This is a wonderful time to be joining the board of BDSI," stated Jeff Bailey.  "The Company has experienced a very successful transition over the last few years and is well positioned to further capitalize on its success.  I look forward to working as a member of the board to help the Company accomplish its ambitions."

    Jeff joins the BDSI board bringing diverse leadership experiences in commercial and supply chain management during a 20+ year career at Johnson & Johnson/Janssen Pharmaceutica as well as during a tenure as an Operating Unit President at Novartis Pharmaceuticals. He also has extensive business development and transactional expertise that includes officer roles during King Pharmaceuticals' acquisition by Pfizer, Fougera Pharmaceuticals' acquisition by Novartis, and as Chairman and CEO during Neurovance's acquisition by Otsuka.  Additionally, Mr. Bailey served as President and CEO of Lantheus Medical Imaging, Inc, taking the company public in 2015.

    Currently, Mr. Bailey serves as Chairman of Aileron Therapeutics since March 2018 and as a Board Member of Madison Vaccines, a privately held biopharmaceutical company, since October 2017.  Since January 2018, Mr. Bailey has served as CEO and Director of IlluminOss Medical, Inc.  Mr. Bailey received a B.S. from Rutgers University.

    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.

    Cautionary Note on Forward-Looking Statements

    This press release and any statements of employees, representatives, and partners of 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 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 2018 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.

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

    Contact:

    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294

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  21. BELBUCA® Effect on Respiratory Drive was Comparable to Placebo in Clinical Trial at all Tested Doses

    Immediate Release Oral Oxycodone HCl Associated with a Dose-Dependent Decrease in Respiratory Drive Compared to Placebo

    RALEIGH, N.C., Feb. 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 presented at the American Academy of Pain Medicine's (AAPM) 36th Annual Meeting the results of a study titled, "A Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride on Respiratory Drive".

    In May 2019, in response to significant…

    BELBUCA® Effect on Respiratory Drive was Comparable to Placebo in Clinical Trial at all Tested Doses

    Immediate Release Oral Oxycodone HCl Associated with a Dose-Dependent Decrease in Respiratory Drive Compared to Placebo

    RALEIGH, N.C., Feb. 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 presented at the American Academy of Pain Medicine's (AAPM) 36th Annual Meeting the results of a study titled, "A Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride on Respiratory Drive".

    In May 2019, in response to significant challenges chronic pain patients face in obtaining adequate care and the ongoing opioid crisis, The Pain Management Best Practices Inter-Agency Task Force report recommended more research activities directed to better understanding the use of buprenorphine, a Schedule III opioid. Opioids can cause serious, life-threatening, or fatal respiratory depression. Respiratory depression is a breathing disorder characterized by slow and ineffective breathing and is the leading cause of opioid related deaths. In this clinical trial, BDSI evaluated the effect of BELBUCA® (buprenorphine buccal film), a Schedule III opioid, and oral oxycodone HCI, a Schedule II opioid, on respiratory drive.

    Study Design:
    – Study subjects (N = 19) were healthy males and females self-identifying as recreational drug users and determined via naloxone challenge to not be physically dependent on opioids.

    – Effect on respiratory drive was assessed using a double-blind, double-dummy, 6-treatment, 6-period, placebo controlled, randomized crossover design. 

    – Treatments studied included single doses of: BELBUCA (300 mcg, 600 mcg, and 900 mcg); oral oxycodone hydrochloride (Oxy 30 mg and 60 mg); and placebo (each separated by a 7-day washout period). 

    – Respiratory drive was evaluated by measuring the ventilatory response to hypercapnia (excess carbon dioxide in the bloodstream) through assessment of the maximum change in minute ventilation (Emax), which is the maximum amount inhaled or exhaled in one minute, after administration of each study drug. Statistical analyses were performed using a linear mixed-effects model.

    Results:
    – The least square mean differences in Emax versus placebo were as follows: Oxy 30 mg (−828.5, P=0.668); Oxy 60 mg (−5188.6, P=0.008); BELBUCA 300 mcg (+1206.9, P=0.533); BELBUCA 600 mcg (+245.4, P=0.896); and BELBUCA 900 mcg (+1473.3, P=0.440).

    A chart/graphic accompanying this announcement is available at:
    https://www.globenewswire.com/NewsRoom/AttachmentNg/d148dcf8-f359-4b36-ada6-dd34da39f6e6

    Conclusion:
    – BELBUCA effect on respiratory drive was comparable to placebo at all doses tested.

    – The effect of immediate release oral oxycodone HCl resulted in a dose-dependent decrease in respiratory drive compared to placebo.

    "This is an important and novel study that shows the comparative effects of buprenorphine buccal film and oral oxycodone on respiratory drive," stated Lynn Webster, M.D., the principal investigator of the study. Thomas Smith, M.D., Chief Medical Officer at BDSI, added, "Consistent with the Task Force's recommendation, BDSI is providing the medical community with the results of this safety study to help providers make informed treatment decisions. This study provides additional scientific support for the use of BELBUCA as a primary treatment option 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."

    Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. 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.

    Please see important safety information about BELBUCA below.

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

    The Pain Management Best Practices Inter-Agency Task Force report is available for viewing online at https://www.hhs.gov/ash/advisory-committees/pain/index.html.

    IMPORTANT SAFETY INFORMATION ABOUT BELBUCA®

    INDICATION
    BELBUCA® (buprenorphine buccal film) 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.

    IMPORTANT SAFETY INFORMATION about BELBUCA®


    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 each patient's risk prior to prescribing BELBUCA, and monitor 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. Misuse or abuse of BELBUCA by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and poses a significant risk of overdose and death.

    Accidental Exposure

    Accidental exposure to even one dose of BELBUCA, especially in 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. If prolonged opioid use is required 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.

    CONTRAINDICATIONS

    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.

    WARNINGS AND PRECAUTIONS

    Addiction, Abuse, and Misuse

    • 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. Addiction can occur at recommended dosages and if the drug is misused or abused.
    • Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing BELBUCA and monitor all patients receiving BELBUCA for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as BELBUCA, but use in such patients necessitates intensive counseling about the risks and proper use of BELBUCA, along with intensive monitoring for signs of addiction, abuse, or misuse.
    • Abuse or misuse of BELBUCA by swallowing may cause choking, overdose, and death.
    • Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing BELBUCA. Strategies to reduce the risk include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug.

    Opioid Analgesic 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. To obtain further information on the REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com
    • Healthcare providers are strongly encouraged to complete a REMS-compliant education program; to discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients or caregivers; to emphasize to patients and caregivers the importance of reading the Medication Guide; and to consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities.

    Life-Threatening Respiratory Depression

    • Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.
    • While serious, life-threatening or fatal respiratory depression can occur at any time during the use of BELBUCA, the risk is greatest during initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression when initiating therapy with BELBUCA and following dosage increases.
    • To reduce the risk of respiratory depression, proper dosing and titration of BELBUCA are essential. Overestimating the dose of BELBUCA when converting patients from another opioid product may result in fatal overdose with the first dose.
    • Accidental exposure to BELBUCA, especially in children, can result in respiratory depression and death due to an overdose of buprenorphine.
    • Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper.

    Neonatal Opioid Withdrawal Syndrome

    • Prolonged use of BELBUCA during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

    Risks due to Interactions with Benzodiazepines or Other Central Nervous System Depressants

    • Profound sedation, respiratory depression, coma, and death may result from the concomitant use of BELBUCA with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

    If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. Follow patients closely for signs and symptoms of respiratory depression and sedation.

    Risk of Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

    • The use of BELBUCA in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
    • BELBUCA-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive, including apnea, even at recommended dosages of BELBUCA.
    • Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared with younger, healthier patients.
    • Monitor such patients closely, particularly when initiating and titrating BELBUCA and when BELBUCA is given concomitantly with other drugs that depress respiration.

    Adrenal Insufficiency

    • Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

    QTc Prolongation

    • BELBUCA has been observed to prolong the QTc interval in some subjects participating in clinical trials. Consider these observations in clinical decisions when prescribing BELBUCA to patients with hypokalemia, hypomagnesemia, or clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia. Periodic electrocardiographic (ECG) monitoring is recommended in these patients. Avoid the use of BELBUCA in patients with a history of Long QT Syndrome or an immediate family member with this condition or those taking Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, dofetilide), or other medications that prolong the QT interval.

    Severe Hypotension

    • BELBUCA may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dosage of BELBUCA. In patients with circulatory shock, BELBUCA may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of BELBUCA in patients with circulatory shock.

    Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

    • In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), BELBUCA may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with BELBUCA.
    • Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of BELBUCA in patients with impaired consciousness or coma.

    Hepatotoxicity

    • Cases of cytolytic hepatitis and hepatitis with jaundice have been observed in individuals receiving sublingual formulations of buprenorphine for the treatment of opioid dependence, both in clinical trials and in post-marketing adverse events reports. For patients at increased risk of hepatotoxicity (e.g., patients with a history of excessive alcohol intake, intravenous drug abuse or liver disease), obtain baseline liver enzyme levels and monitor periodically during treatment with BELBUCA.

    Risk of Overdose in Patients with Moderate or Severe Hepatic Impairment

    • In a pharmacokinetic study of subjects dosed with buprenorphine sublingual tablets, buprenorphine plasma levels were found to be higher and the half-life was found to be longer in subjects with moderate and severe hepatic impairment, but not in subjects with mild hepatic impairment. For patients with severe hepatic impairment, a dose adjustment is recommended, and patients with moderate or severe hepatic impairment should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.

    Anaphylactic/Allergic Reactions

    • Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in post-marketing experience. The most common signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported.

    Withdrawal

    • Do not abruptly discontinue BELBUCA in a patient physically dependent on opioids. When discontinuing BELBUCA in a physically dependent patient, gradually taper the dosage. Rapid tapering of buprenorphine in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain.
    • Additionally, the use of BELBUCA, a partial agonist opioid analgesic, in patients who are receiving a full opioid agonist analgesic may reduce the analgesic effect and/or precipitate withdrawal symptoms. Avoid concomitant use of BELBUCA with a full opioid agonist analgesic.

    Risk of Use in Patients with Gastrointestinal Conditions

    • BELBUCA is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
    • BELBUCA may cause spasm of the sphincter of Oddi. Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

    Increased Risk of Seizures in Patients with Seizure Disorders

    • The buprenorphine in BELBUCA may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during BELBUCA therapy.

    Risks of Use in Cancer Patients with Oral Mucositis

    • Cancer patients with oral mucositis may absorb buprenorphine more rapidly than intended and are likely to experience higher plasma levels of the opioid. For patients with known or suspected mucositis, a dose reduction is recommended. Monitor these patients carefully for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.

    Risks of Driving and Operating Machinery

    • BELBUCA may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to side effects of BELBUCA and know how they will react to the medication.

    ADVERSE REACTIONS

    • The most common adverse reactions (≥5%) reported by patients treated with BELBUCA in the clinical trials were nausea, constipation, headache, vomiting, fatigue, dizziness, and somnolence.

    Please see full Prescribing Information, including Boxed Warning and Medication Guide, for BELBUCA.

    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.

    Intended for healthcare professionals of the United States of America only.

    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.

    Cautionary Note on Forward-Looking Statements
    This press release and any statements of employees, representatives, and partners of 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 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 2018 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.

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

    Contact:
    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294


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  22. RALEIGH, N.C., Feb. 20, 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 fourth quarter and full year 2019 financial results after the close of the U.S. financial markets on Thursday, March 12, 2020. The company will host a conference call and webcast at 4:30 PM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date:  Thursday, March 12, 2020
    Time: 4:30 PM Eastern Time
    Domestic: 877-407-0789
    International: 201-689-8562
    Conference ID: 13699178
    Webcast: http://public.viavid.com/index.php?id=138131

    RALEIGH, N.C., Feb. 20, 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 fourth quarter and full year 2019 financial results after the close of the U.S. financial markets on Thursday, March 12, 2020. The company will host a conference call and webcast at 4:30 PM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date:  Thursday, March 12, 2020
    Time: 4:30 PM Eastern Time
    Domestic: 877-407-0789
    International: 201-689-8562
    Conference ID: 13699178
    Webcast: http://public.viavid.com/index.php?id=138131

    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:
    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294

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  23. 2019 Total Company Net Sales Expected at Upper End of $105 to $110 Million

    More than 25 Million Additional Lives Moved to Preferred Coverage for Symproic® effective January 1, 2020

    RALEIGH, N.C., Jan. 13, 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 a large national pharmacy benefit manager (PBM), along with various healthcare insurance companies, have expanded access for Symproic® to more than 25 million additional commercial covered lives by placing Symproic in preferred formulary position beginning on January 1, 2020.  This brings the total to more than 40 million…

    2019 Total Company Net Sales Expected at Upper End of $105 to $110 Million

    More than 25 Million Additional Lives Moved to Preferred Coverage for Symproic® effective January 1, 2020

    RALEIGH, N.C., Jan. 13, 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 a large national pharmacy benefit manager (PBM), along with various healthcare insurance companies, have expanded access for Symproic® to more than 25 million additional commercial covered lives by placing Symproic in preferred formulary position beginning on January 1, 2020.  This brings the total to more than 40 million commercially covered lives that have received expanded access to Symproic in preferred formulary position since October 1, 2019.

    In addition, the Company announced that 2019 full year total company net sales are expected to be at the upper end of previously provided guidance of $105-$110 million, driven by continued strong fourth quarter performance of both BELBUCA® (buprenorphine buccal film), CIII and Symproic.   The Company also reiterated its previously announced 2020 full year net sales guidance of $150-$160 million for BELBUCA and $165-$175 million for total company.

    "I am very pleased by the significant progress made in ensuring patients suffering from opioid induced constipation have appropriate access to our clinically-differentiated drug, Symproic," stated Herm Cukier, CEO of BDSI.  "Gaining such a substantial additional number of covered lives enables us to build upon the very strong momentum we experienced during the fourth quarter for both BELBUCA and Symproic, and further adds to my excitement and enthusiasm for a very successful 2020 and the future of BDSI."

    About Symproic

    Symproic® (naldemedine) tablets 0.2 mg is indicated for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Symproic® was made available to patients in the U.S. in October 2017.

    Important Safety Information about Symproic®

    CONTRAINDICATIONS

    Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation.

    Patients with a history of a hypersensitivity reaction to Symproic. Reactions have included bronchospasm and rash.

    WARNINGS AND PRECAUTIONS

    Cases of GI perforation have been reported with use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.

    Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, increased lacrimation, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhea, nausea, and vomiting have occurred in patients treated with Symproic.

    Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Take into account the overall risk-benefit profile when using Symproic in such patients. Monitor for symptoms of opioid withdrawal in such patients.

    DRUG INTERACTIONS

    Avoid use with strong CYP3A inducers (e.g., rifampin) because they may reduce the efficacy of Symproic.

    Use with moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A inhibitors and P-glycoprotein inhibitors (e.g., cyclosporine) may increase Symproic concentrations. Monitor for potential adverse reactions.

    Avoid use of Symproic with another opioid antagonist due to potential for additive effect and increased risk of opioid withdrawal.

    USE IN SPECIFIC POPULATIONS

    Symproic crosses the placenta and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. Symproic should be used during pregnancy only if the potential benefit justifies the potential risk. Because of the potential for serious adverse reactions, including opioid withdrawal in breastfed infants, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

    Avoid use in patients with severe hepatic impairment. No dose adjustment of Symproic is required in patients with mild or moderate hepatic impairment.

    ADVERSE REACTIONS

    The most common adverse reactions with Symproic as compared to placebo in clinical trials were: abdominal pain (8% vs 2%), diarrhea (7% vs 2%), nausea (4% vs 2%), and gastroenteritis (2% vs 1%).

    In pooled Studies 1 and 2, the incidence of adverse reactions of opioid withdrawal was 1% (8/542) for Symproic and 1% (3/546) for placebo. In Study 3 (52-week data), the incidence was 3% (20/621) for Symproic and 1% (9/619) for placebo.

    To report suspected Adverse Reactions, contact Shionogi at 1-800-849-9707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see accompanying Full Prescribing Information including Medication Guide for Symproic or visit www.symproic.com/pi.

    References:

    1. Sehgal N, Colson J, Smith HS. Chronic pain treatment with opioid analgesics: benefits versus harms of long-term therapy. Expert Rev Neurother. 2013;13:1201-1220.
    2. Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014;26: 1386-1395.
    3. Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic noncancer pain: systematic review of efficacy and safety. Pain. 2004;112:372–80.
    4. Cook SF, Lanza L, Zhou X, et al. Gastrointestinal side effects in chronic opioid users: results from a population based survey. Aliment Pharmacol Ther. 2008;27(12):1224-1232.
    5. Brown RT, Zuelsdorff M, Fleming M. Adverse effects and cognitive function among primary care patients taking opioids for chronic nonmalignant pain. J Opioid Manag. 2006;2(3):137–146.
    6. Tuteja AK, Biskupiak J, Stoddard GJ, Lipman AG. Opioid induced bowel disorders and narcotic bowel syndrome in patients with chronic non-cancer pain. Neurogastroenterol Motil. 2010;22(4):424-430.

    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.

    About BELBUCA®

    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, opioid dependence, and opioid-induced constipation.

    Cautionary Note on Forward-Looking Statements

    This press release and any statements of employees, representatives, and partners of 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 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 2018 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.

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

    Contact:

    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294

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  24. RALEIGH, N.C., Jan. 06, 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, announced today the appointment of Kevin Ostrander as Senior Vice President of Business Development and member of the Company Executive Leadership Team, effective today January 6.  Mr. Ostrander brings nearly thirty years of significant experience executing a multitude of business development strategies, including in-licensing and acquisition of products, establishing joint ventures and strategic partnerships, and creating and running platform collaborations. 

    "I am pleased to welcome Kevin to our rapidly growing…

    RALEIGH, N.C., Jan. 06, 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, announced today the appointment of Kevin Ostrander as Senior Vice President of Business Development and member of the Company Executive Leadership Team, effective today January 6.  Mr. Ostrander brings nearly thirty years of significant experience executing a multitude of business development strategies, including in-licensing and acquisition of products, establishing joint ventures and strategic partnerships, and creating and running platform collaborations. 

    "I am pleased to welcome Kevin to our rapidly growing Company," stated Herm Cukier, CEO of BDSI. "His profound experience in completing more than 75 transactions over three decades is a great addition to our leadership team as we build upon our strong growth momentum into 2020 and beyond."

    "I am delighted to join BDSI during this time of rapid growth at the Company and lead its business development efforts," stated Kevin Ostrander.  "I am greatly looking forward to capitalizing on the strengths of our organization to build a broader portfolio of leading differentiated products that improve the lives of patients living with serious and complex chronic conditions."

    Kevin joins BDSI from Glenmark Pharmaceuticals where he was Head of North America Business Development.  He previously held leadership positions in business and corporate development with a diverse range of pharmaceutical and healthcare companies including Mylan, Sandoz, Watson, and Cardinal Health.  Kevin started his career as a research and formulation scientist with companies such as Elan and Nycomed.  He holds a number of patents and has authored several publications in tier one journals.  Mr. Ostrander received an MS from Temple University School of Pharmacy, an MBA from St. Joseph's University, and a Bachelor's in Biology from the State University of New York at Albany.

    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.

    Cautionary Note on Forward-Looking Statements

    This press release and any statements of employees, representatives, and partners of 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 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 2018 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.

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

    Contact:
    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294

    Primary Logo

    View Full Article Hide Full Article
  25. RALEIGH, N.C., Dec. 19, 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 announced it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI). BDSI's addition to the NBI will become effective prior to market open on Monday, December 23, 2019.

    Companies in the NBI must meet eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria. All securities in the NBI index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market, which BDSI was accepted into in October 2019. 

    The NBI is designed…

    RALEIGH, N.C., Dec. 19, 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 announced it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI). BDSI's addition to the NBI will become effective prior to market open on Monday, December 23, 2019.

    Companies in the NBI must meet eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria. All securities in the NBI index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market, which BDSI was accepted into in October 2019. 

    The NBI is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB).  Additionally, the NBI serves as the basis for the Blackrock iShares Nasdaq Biotechnology ETF (NASDAQ:IBB), the largest ETF that tracks this index directly.  For more information about the NASDAQ Biotechnology Index, please visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

    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 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 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 2018 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:

    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294

    Primary Logo

    View Full Article Hide Full Article
  26. RALEIGH, N.C., Dec. 11, 2019 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions, today announced the launch of This Is Pain, a long-term initiative that aims to improve the lives of over 10 million1 American adults living with chronic pain.  As part of the initiative, actress Kristin Chenoweth is sharing her personal experience with chronic pain to help spread awareness around the disease.

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    "In 2012, I suffered an injury while on set filming a TV show. Even though I looked 'fine' I did not feel 'fine' and for me that is the hardest part about pain; it is impossible to see and it left me feeling very…

    RALEIGH, N.C., Dec. 11, 2019 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions, today announced the launch of This Is Pain, a long-term initiative that aims to improve the lives of over 10 million1 American adults living with chronic pain.  As part of the initiative, actress Kristin Chenoweth is sharing her personal experience with chronic pain to help spread awareness around the disease.

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    "In 2012, I suffered an injury while on set filming a TV show. Even though I looked 'fine' I did not feel 'fine' and for me that is the hardest part about pain; it is impossible to see and it left me feeling very low. Thankfully I have great support, and I am lucky enough to be able to continue to work."

    Chronic pain is one of the most common reasons2 that Americans visit a healthcare professional and yet this disease is widely misunderstood and can be incredibly isolating, debilitating and frustrating for those living with it. This is in large part, due to the fact that each person's pain is highly individualized and not visible to their peers, colleagues and wider society.

    This Is Pain seeks to first confront the stigma around the disease state, creating widespread awareness and empathy, to ultimately combat the systemic challenges those living with chronic pain face. These challenges include experiencing unfair treatment in the workplace and difficulty in accessing affordable treatment options. The long-term goals of the campaign include achieving the following:

    1. Wider societal recognition of chronic pain as a disease state, not a symptom;
    2. Policy change to increase access to safe and effective treatment options for individuals living with chronic pain;
    3. Increased research funding to improve existing treatments and develop innovative therapies for individuals living with chronic pain; and
    4. Fairer treatment and representation in the workplace.

    "People living with chronic pain face unimaginable hurdles and struggles in their daily lives and I believe that we can alleviate some of the challenges they face by first drawing attention to what it is really like to live with pain," stated Herm Cukier, CEO of BDSI. "We know that change is borne out of a communal desire to act and that is exactly what we need to achieve to impact the lives of those living with chronic pain."

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    Penney Cowan of the ACPA says of the exhibition, "If we can encourage people to take a moment out of their day to learn about the disease and really see how this disease impacts those living with chronic pain, we believe we can start to generate the support we need to effect real change."

    To learn more about the This Is Pain campaign and chronic pain as a disease state, visit www.ThisIsPain.com and follow us on social media platforms @thisispain.

    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 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 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 2018 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.

    1 Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of chronic pain and high impact chronic pain among adults – United States, 2016. MMWR. September 14, 2018

    2 "NIH Funds $945 Million in Research to Tackle the National Opioid Crisis through NIH HEAL Initiative." National Institutes of Health, U.S. Department of Health and Human Services, 26 Sept. 2019, www.nih.gov/news-events/news-releases/nih-funds-945-million-research-tackle-national-opioid-crisis-through-nih-heal-initiative.

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    BDSI has partnered with visual artist Trina Merry and the American Chronic Pain Association (ACPA) to bring to life the stories of eight individuals who are living with chronic pain. The one-of-a kind artwork will be displayed in an exhibition at Oculus Plaza in New York City starting December 12th through December 15th.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/emmy-and-tony-award-winning-actress-kristin-chenoweth-introduces-this-is-pain-campaign-to-improve-the-lives-of-those-living-with-chronic-pain-300973217.html

    SOURCE BioDelivery Sciences International, Inc.

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  27. RALEIGH, N.C., Nov. 27, 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 announced that Herm Cukier, Chief Executive Officer, will participate in an analyst-led fireside chat at the upcoming Piper Jaffray 31st Annual Healthcare Conference taking place December 3 - 5, 2019 in New York, NY.

    Event: Piper Jaffray 31st Annual Healthcare Conference
    Date: Wednesday, December 4, 2019
    Time: 12:00pm – 12:25pm Eastern Time
    Location: Lotte New York Palace, New York, NY

    The management team will also host one-on-one investor meetings at the conference. For investors attending the…

    RALEIGH, N.C., Nov. 27, 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 announced that Herm Cukier, Chief Executive Officer, will participate in an analyst-led fireside chat at the upcoming Piper Jaffray 31st Annual Healthcare Conference taking place December 3 - 5, 2019 in New York, NY.

    Event: Piper Jaffray 31st Annual Healthcare Conference
    Date: Wednesday, December 4, 2019
    Time: 12:00pm – 12:25pm Eastern Time
    Location: Lotte New York Palace, New York, NY

    The management team will also host one-on-one investor meetings at the conference. For investors attending the Piper Jaffray conference, please contact BDSI Investor Relations to schedule a meeting with management at .

    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 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 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 2018 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:

    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294

    Primary Logo

    View Full Article Hide Full Article
  28. RALEIGH, N.C., Nov. 25, 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 announced that it has named Vanila M. Singh, M.D., MACM, to its Board of Directors.

    Dr. Singh is currently a Clinical Associate Professor of Anesthesiology, Pain and Peri-operative Medicine at Stanford University School of Medicine and is a teaching mentor at Walter Reed National Military Medical Center.  Dr. Singh is the immediate past Chief Medical Officer of the United States Department of Health and Human Services (HHS) and served as Chairperson of the Inter-Agency Pain Management Best Practices Task Force…

    RALEIGH, N.C., Nov. 25, 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 announced that it has named Vanila M. Singh, M.D., MACM, to its Board of Directors.

    Dr. Singh is currently a Clinical Associate Professor of Anesthesiology, Pain and Peri-operative Medicine at Stanford University School of Medicine and is a teaching mentor at Walter Reed National Military Medical Center.  Dr. Singh is the immediate past Chief Medical Officer of the United States Department of Health and Human Services (HHS) and served as Chairperson of the Inter-Agency Pain Management Best Practices Task Force, chartered by Congress and involving multiple federal health agencies, professional medical organizations, and patient advocacy groups to guide the medical community and key stakeholders in optimal patient care in a growing and complex national health matter.

    "We are very excited and honored to have Dr. Singh join our organization as a Board member," stated Peter Greenleaf, Chairman of BDSI.  "Vanila's profound knowledge and experience in the fields of molecular science, clinical care, public health, and matters of national health policy will be wonderful complements to the significant depth of capabilities already on our Board and across the organization.  Her passion and national recognition as an ambassador for optimal patient care blends perfectly with our company's patient centric culture and commitment to commercializing clinically differentiated products with meaningful therapeutic value."

    "Having spent my clinical career and policy-making leadership focused on improving clinical outcomes through best practices and patient-centered recommendations, I am proud to extend my vision by joining BDSI's Board and to further deliver solutions that address unmet patient care and focus on challenges that affect the healthcare system," added Dr. Singh.

    Dr. Singh, board-certified in both anesthesiology and pain medicine, specializes in treating patients with complex chronic pain issues. She graduated from the University of California at Berkeley with a Bachelor of Science degree in both molecular and cell biology and economics. She received her Medical degree from the George Washington University School of Medicine & Health Sciences. Dr. Singh completed her internal medicine internship at Yale University School of Medicine and her anesthesiology residency and pain medicine fellowship at Weill-Cornell New York Presbyterian Hospital, which included training at Memorial Sloan Kettering and the Hospital for Special Surgery. She received a master's degree in academic medicine through the University of Southern California's Keck School of Medicine in 2016. Dr. Singh has been active in various national medical organizations, having served in the past as the Vice Chair of the National Physicians Council on Health Policy; an editorial board member of the Pain Physician Journal for the American Society of Interventional Pain Physicians; and a member of the California Medical Association's (CMA) House of Delegates. She also served on the CMA's Council on Ethical, Legal and Judicial Affairs, and more recently, as a member of its Subcommittee on Health Information Technology, scientific planning committee of the American Society of Regional Anesthesia and Pain, and an active member of the American Society of Anesthesiology.  In 2018 she was honored with a Lifetime Achievement Award by the American Society of Interventional Pain Physicians.

    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 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 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 2018 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:

    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294

    Primary Logo

    View Full Article Hide Full Article
  29. BELBUCA® Net Sales Increased by 115% versus Prior Year to All-time High of $26.5 Million

    Raises Full Year 2019 Total Company Net Sales Expectations to $105 - $110 Million

    Provides Full Year 2020 BELBUCA Net Sales Expectations of $150 - $160 Million and Total Company Net Sales Expectations of $165 - $175 Million

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

    RALEIGH, N.C., Nov. 12, 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 third quarter ended September 30, 2019, as well as the following operational and performance highlights…

    BELBUCA® Net Sales Increased by 115% versus Prior Year to All-time High of $26.5 Million

    Raises Full Year 2019 Total Company Net Sales Expectations to $105 - $110 Million

    Provides Full Year 2020 BELBUCA Net Sales Expectations of $150 - $160 Million and Total Company Net Sales Expectations of $165 - $175 Million

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

    RALEIGH, N.C., Nov. 12, 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 third quarter ended September 30, 2019, as well as the following operational and performance highlights.

    Key Business Highlights:

    • Total Company net revenue increased by 114% versus the prior year period to a new all-time high of $30.3 million. This growth was driven by BELBUCA® (buprenorphine buccal film), CIII sales of $26.5 million, an increase of 115% versus the prior year period, and the addition of Symproic® (naldemedine) tablets 0.2mg to the commercial portfolio.
    • Total BELBUCA prescriptions of more than 89,600 for the quarter were the highest ever for any three-month period.  In addition, BELBUCA achieved record year over year prescription volume growth of more than 45,000 during the quarter.
    • Total Symproic prescriptions reached an all-time high of 15,686, representing more than 39% growth versus the prior year period.
    • Achieved record number of unique prescribers during the quarter for both BELBUCA and Symproic.
    • Significantly improved insurance coverage for BELBUCA by adding an additional 14 million covered lives within commercial and health exchange plans with preferred status as of January 1, 2020.  This brings the total commercial coverage for BELBUCA to more than 90% of covered lives, with approximately 60% being in preferred status.
    • Achieved substantial increase in insurance coverage for Symproic by adding more than 14 million commercial covered lives having preferred or preferred exclusive coverage by January 1, 2020, bringing the total commercial coverage for Symproic to more than 40% in preferred or preferred exclusive status.
    • Strong presence at the PAINWeek® 2019 National Conference on Pain for Frontline Practitioners, including the presentation of five scientific posters about BELBUCA and Symproic.

    "The third quarter was, once again, highlighted by very strong performance and achievements across the entire organization," stated Herm Cukier, CEO of BDSI. "We continue to see significant growth momentum for BELBUCA and positive indicators of growth emerging for Symproic.  The success achieved in the third quarter marks the sixth straight quarter of sustained rapid growth and fuels our confidence to raise total net sales expectations for full year 2019 and provide expectations for 2020.  Given the increased utilization by physicians, significantly expanded access across payers, and tailwinds from federal health policy initiatives, I believe BELBUCA and Symproic are positioned for sustained growth."

    The Company raised expectations for full year 2019 total net sales to $105 - $110 million from the previous level of $101 - $105 million, and reiterated the expectation to be operationally cash flow positive during the fourth quarter.  In addition, BDSI provided full year 2020 BELBUCA net sales expectations of $150 – $160 million and total Company net sales expectations of $165 – $175 million.

    Third Quarter 2019 Financial Results

    Total Net Revenue. Total net revenue for the third quarter ended September 30, 2019 was $30.3 million, an increase of 114% compared to $14.2 million in the third quarter of 2018, and an increase of 2% compared to $29.7 million in the second quarter of 2019.

    BELBUCA Net Sales in the third quarter were $26.5 million, an increase of 115% compared to $12.4 million in the third quarter of 2018, and an increase of 10% compared to $24.1 million in the second quarter of 2019.

    Symproic Net Sales in the third quarter were $2.2 million, $1.0 million below the second quarter net sales which had benefited from an agreed fee as part of a distribution agreement with Shionogi.  The third quarter was the first full quarter of commercialization following acquisition of the product and reflects a standard gross to net revenue deductions approach.

    Bunavail® Net Sales in the third quarter were $0.9 million, a reduction of $0.5 million compared to the third quarter of 2018 and an increase of $0.1 million compared to the second quarter of 2019.

    Product Royalty Revenue in the third quarter was $0.7 million, an increase of $0.3 million compared to the third quarter of 2018 and a reduction of $0.9 million compared to the second quarter of 2019.

    Total Operating Expenses. Total operating expenses in the quarter ended September 30, 2019 were $23.4 million, compared to $22.0 million in the second quarter of 2019 and $14.2 million in the third quarter of 2018.  The growth compared to the second quarter of 2019 reflects ongoing investments in marketing, sales and medical affairs.

    GAAP Net Income. GAAP net income for the quarter was $0.4 million compared to GAAP net loss of $11.1 million for the second quarter of 2019 and GAAP net loss of $6.4 million in the third quarter of 2018.

    EBITDA in the third quarter of 2019 was $3.5 million or 11.6% of net sales, compared to $4.8 million in the second quarter of 2019 and ($2.3) million in the third quarter of 2018. 

    Non-GAAP Net Income. Non-GAAP net income for the quarter was $3.5 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets.

    Cash Position. As of September 30, 2019, cash and cash equivalents were approximately $55.9 million, compared to cash and cash equivalents of $43.8 million as of December 31, 2018.

    Conference Call & Webcast Details

    BioDelivery Sciences will host a conference call and webcast today, November 12, 2019, at 4:30 p.m. ET to present third quarter 2019 results and to provide a business update.  Dial-in details are as follows:

    Date:  Tuesday, November 12, 2019
    Time: 4:30 PM EST
    Domestic: 877-407-0789
    International: 201-689-8562
    Passcode: 13696283
    Webcast: http://public.viavid.com/index.php?id=136899
       

    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 long-term combined BELBUCA and Symproic net sales and BELBUCA net sales and total company net revenue in 2019 and 2020 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.

    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 from GAAP results: stock-based compensation expense, amortization of intangible assets, amortization of certain warrant discount costs and the financial impact of our debt refinancing which closed in May 2019, as it is non-recurring.

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

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

    Contact:

    Tirth Patel
    Director of Investor Relations
    (919) 582-0294

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
    (Unaudited)

      September 30,
    2019
      December 31,
    2018
    ASSETS      
    Current assets:      
    Cash and cash equivalents $ 55,863     $ 43,822  
    Accounts receivable, net 33,422     13,627  
    Inventory, net 10,766     5,406  
    Prepaid expenses and other current assets 4,874     3,188  
    Total current assets 104,925     66,043  
    Property and equipment, net 3,713     3,072  
    Goodwill 2,715     2,715  
    License and distribution rights, net 62,044     36,000  
    Other intangible assets, net 211     703  
    Total assets $ 173,608     $ 108,533  
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable and accrued liabilities $ 46,545     $ 21,539  
    Total current liabilities 46,545     21,539  
    Notes payable, net 58,515     51,652  
    Other long-term liabilities 654     5,600  
    Total liabilities 105,714     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 September 30, 2019 and December 31, 2018, respectively; Series B Non-Voting Convertible Preferred Stock, $.001 par value, 1,698 and 3,100 shares outstanding at September 30, 2019 and December 31, 2018, respectively. 2     2  
    Common Stock, $.001 par value; 175,000,000 shares authorized at September 30, 2019 and 125,000,000 shares authorized at December 31, 2018, respectively; 89,796,774 and 70,793,725 shares issued;89,781,283 and 70,778,234 shares outstanding at September 30, 2019 and December 31, 2018, respectively. 90     71  
    Additional paid-in capital 433,746     381,004  
    Treasury stock, at cost, 15,491 shares (47 )   (47 )
    Accumulated deficit (365,897 )   (351,288 )
    Total stockholders' equity 67,894     29,742  
    Total liabilities and stockholders' equity $ 173,608     $ 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 September 30,   Nine months ended September 30,
      2019   2018   2019   2018
    Revenues:              
    Product sales $ 29,623     $ 13,763     $ 77,438     $ 34,367  
    Product royalty revenues 683     370     2,154     2,197  
    Contract revenues     23     160     1,047  
    Total Revenues: 30,306     14,156     79,752     37,611  
    Cost of sales 5,350     3,779     14,325     11,760  
    Expenses:              
    Research and development     699         4,038  
    Selling, general and administrative 23,360     13,489     62,304     41,013  
    Total Expenses: 23,360     14,188     62,304     45,051  
    Income (loss) from operations 1,596     (3,811 )   3,123     (19,200 )
    Interest expense (1,234 )   (2,567 )   (17,732 )   (7,598 )
    Other (expense) income, net (3 )   (2 )   5     (8 )
    Income (loss) before income taxes $ 359     $ (6,380 )   $ (14,604 )   $ (26,806 )
    Income tax expense (5 )       (5 )   (53 )
    Net income (loss) $ 354     $ (6,380 )   $ (14,609 )   $ (26,859 )
    Beneficial conversion feature of convertible preferred stock     (12,500 )       (12,500 )
    Net income (loss) attributable to common stockholders $ 354     $ (18,880 )   $ (14,609 )   $ (39,359 )
    Basic              
    Weighted average common stock shares outstanding 89,649,922     64,900,007     81,612,112     60,599,456  
    Basic earnings (loss) per share $     $ (0.29 )   $ (0.18 )   $ (0.65 )
    Diluted              
    Weighted average common stock shares outstanding 105,138,894     64,900,007     81,612,112     60,599,456  
    Diluted earnings (loss) per share $     $ (0.29 )   $ (0.18 )   $ (0.65 )
                                   

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    (U.S. DOLLARS, IN THOUSANDS)
    (Unaudited)

      Nine months ended September 30,
      2019   2018
    Operating activities:      
    Net loss $ (14,609 )   $ (26,859 )
    Adjustments to reconcile net loss to net cash flows from operating activities      
    Depreciation and amortization 253     685  
    Impairment loss on equipment     78  
    Accretion of debt discount and loan costs 11,441     2,953  
    Amortization of intangible assets 5,084     3,868  
    Provision for inventory obsolescence 57     396  
    Stock-based compensation expense 3,978     4,896  
    Changes in assets and liabilities, net of effect of acquisition:      
    Accounts receivable (19,795 )   (3,581 )
    Inventories (5,416 )   261  
    Prepaid expenses and other assets (1,686 )   (545 )
    Accounts payable and accrued liabilities 14,844     (427 )
    Net cash flows used in operating activities (5,849 )   (18,275 )
    Investing activities:      
    Product acquisitions (20,674 )   (1,951 )
    Acquisitions of equipment (79 )   (155 )
    Net cash flows used in investing activities (20,753 )   (2,106 )
    Financing activities:      
    Proceeds from issuance of common stock 48,000      
    Proceeds from issuance of Series B preferred stock     50,000  
    Equity issuance costs (410 )   (1,410 )
    Proceeds from notes payable 60,000      
    Proceeds from exercise of stock options 1,193     528  
    Payment on note payable (67,346 )    
    Loss on refinancing of former debt (2,794 )    
    Payment of deferred financing fees     (450 )
    Net cash flows provided by financing activities 38,643     48,668  
    Net change in cash and cash equivalents 12,041     28,287  
    Cash and cash equivalents at beginning of period 43,822     21,195  
    Cash and cash equivalents at end of period $ 55,863     $ 49,482  
                   

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    RECONCILIATION OF NON-GAAP METRICS
    (U.S. DOLLARS, IN THOUSANDS)
    (Unaudited)

      Three Months Ended
    September 30,
      Nine Months Ended
    September 30,
    Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) 2019 2018   2019 2018
    GAAP net income/(loss) $ 354 $ (6,380 )   $ (14,609 ) $ (26,859 )
    Add back:          
    Provision for income taxes 4     4   53  
    Net interest expense 1,237 2,569     17,727   7,606  
    Depreciation and amortization 1,904 1,519     5,259   4,718  
    EBITDA $ 3,499 $ (2,292 )   $ 8,381   $ (14,482 )
    Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)          
    GAAP net income/(loss) 354 (6,380 )   (14,609 ) (26,859 )
    Non-GAAP adjustments:          
    Stock-based compensation expense 1,267 892     3,978   4,896  
    Amortization of intangible assets 1,898 1,289     5,084   3,868  
    Amortization of warrant discount 269     448   807  
    Non-recurring financial impact of debt refinance     11,866    
    Non-GAAP net income/(loss) $ 3,519 $ (3,930 )   $ 6,767   $ (17,288 )
                             

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  30. RALEIGH, N.C., Nov. 07, 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 announced that Herm Cukier, Chief Executive Officer, will present at the upcoming Jefferies Global Healthcare Conference in London on November 20, 2019. The management team will also host one-on-one investor meetings at the conference.

    Presentation Details:
    Date: Wednesday, November 20
    Time: 6:00 PM GMT
    Webcast: http://wsw.com/webcast/jeff123/bdsi/

    A replay of the presentation will be archived on the Company's website and made available for 60 days.
                 
    ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.

    BioDelivery…

    RALEIGH, N.C., Nov. 07, 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 announced that Herm Cukier, Chief Executive Officer, will present at the upcoming Jefferies Global Healthcare Conference in London on November 20, 2019. The management team will also host one-on-one investor meetings at the conference.

    Presentation Details:
    Date: Wednesday, November 20
    Time: 6:00 PM GMT
    Webcast: http://wsw.com/webcast/jeff123/bdsi/

    A replay of the presentation 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 and those in development address serious and debilitating conditions such as chronic pain, breakthrough cancer pain, opioid dependence, and opioid-induced constipation.

    Contact:

    Bob Yedid
    LifeSci Advisors, LLC
    (646) 597-6989

    Primary Logo

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  31. RALEIGH, N.C., Oct. 30, 2019 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a specialty pharmaceutical company dedicated to patients living with chronic conditions, today announced its plans to report its third-quarter 2019 financial results after the close of the U.S. financial markets on Tuesday, November 12, 2019.  The company will host a conference call and webcast at 4:30 p.m. EST to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date:  Tuesday, November 12, 2019
    Time: 4:30 PM EST
    Domestic: 877-407-0789
    International: 201-689-8562
    Conference ID: 13696283
    Webcast: http://public.viavid.com/index.php?id=136899
       

    About BioDelivery Sciences International,

    RALEIGH, N.C., Oct. 30, 2019 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a specialty pharmaceutical company dedicated to patients living with chronic conditions, today announced its plans to report its third-quarter 2019 financial results after the close of the U.S. financial markets on Tuesday, November 12, 2019.  The company will host a conference call and webcast at 4:30 p.m. EST to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date:  Tuesday, November 12, 2019
    Time: 4:30 PM EST
    Domestic: 877-407-0789
    International: 201-689-8562
    Conference ID: 13696283
    Webcast: http://public.viavid.com/index.php?id=136899
       

    About BioDelivery Sciences International, Inc.

    BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company dedicated to patients living with chronic conditions.  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 chronic pain, breakthrough cancer pain, and opioid dependence.  For more information, please visit us https://bdsi.com or follow us on Facebook or Twitter BDSI @BioDeliverySI.

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

    Contacts
    Bob Yedid
    LifeSci Advisors, LLC
    (646) 597-6989

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  32. Calidi Biotherapeutics, Inc. ("Calidi"), a clinical‐stage biotechnology company at the forefront of oncolytic virus-based immunotherapies for cancer, today announced the appointment of seasoned biotech executive, George Ng, Partner of PENG Life Science Ventures. His extensive background includes co-founding and leading the efforts of a pharmaceutical company from pre-clinical to clinical to New Drug Application (NDA) submission to commercialization and subsequent sale of the company. In the process, he raised more than $140 million in non-dilutive funding to commercialize its FDA-approved pain medication. Calidi believes Mr. Ng's experience will help to accelerate the growth of the company and its proprietary and novel cell-based oncolytic…

    Calidi Biotherapeutics, Inc. ("Calidi"), a clinical‐stage biotechnology company at the forefront of oncolytic virus-based immunotherapies for cancer, today announced the appointment of seasoned biotech executive, George Ng, Partner of PENG Life Science Ventures. His extensive background includes co-founding and leading the efforts of a pharmaceutical company from pre-clinical to clinical to New Drug Application (NDA) submission to commercialization and subsequent sale of the company. In the process, he raised more than $140 million in non-dilutive funding to commercialize its FDA-approved pain medication. Calidi believes Mr. Ng's experience will help to accelerate the growth of the company and its proprietary and novel cell-based oncolytic virus delivery platform.

    "We are honored to have George Ng join our board of directors. He is a recognized leader in the development, operation, and growth of biotech organizations worldwide. His contributions have played a significant role in the development and commercialization of multiple drugs across several therapeutic areas," said Allan J. Camaisa, CEO and Chairman of Calidi Biotherapeutics. "We look forward to fully utilizing his experience as we head into Phase 2 clinical trials. We think his sincere approach to leading organizations will be a fantastic fit for the Calidi Biotherapeutics team."

    Calidi Biotherapeutics's proprietary technology platform has shown to significantly potentiate oncolytic virotherapy through a cell-based delivery system. In their first-in-human study in 26 patients with advanced metastatic cancer, Calidi demonstrated excellent safety and initial signals of efficacy after a single treatment administration. Following discussions with the Food and Drug Administration (FDA) Calidi is preparing an Investigational New Drug (IND) application to commence new Phase 1b/2 clinical trials for their leading product candidate in patients with melanoma and other solid tumors.

    "I am excited to join Calidi Biotherapeutics on their mission to treat, and hopefully cure difficult-to-treat cancer types," said George Ng, newly appointed board member of Calidi Biotherapeutics. "Calidi is primed and ready to take the industry by storm. It is exciting to see the advances they have made in overcoming the hurdle of oncolytic viruses being eliminated by the patient's immune system."

    Previously Mr. Ng was the President, Managing Director, Chief Administrative Officer, Corporate Secretary, Chief Legal Officer, General Counsel, Chief Compliance Officer and Chief Intellectual Property Counsel, with multiple publicly-traded and private, global biotechnology and pharmaceutical companies, including BioDelivery Sciences International, Inc. (NASDAQ:BDSI), Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) and Alpharma, Inc. (now, a part of Pfizer Inc.). In these roles, Mr. Ng helped lead the commercialization efforts and launches of multiple pharmaceutical drug products. During his early years, Mr. Ng was in private practice, as a partner in two AMLAW-200 law firms, where he held various leadership roles and helped establish a life science practice group for one of these firms.

    Among his multiple awards and commendations, Mr. Ng was a recipient of the 2015 Outstanding 50 Asian Americans in Business Award, past recipient of M&A Advisor's Top 40 Under 40 Award (in 2012) and nominee for the Orange County Business Journal's Inaugural General Counsel Awards (in 2010); and, in 2010, MDB Capital recognized Mr. Ng (and the company where he led the intellectual property efforts) for its Best and Brightest Award and as an Astrum Award nominee for a pharmaceutical patent portfolio that he managed and developed. Mr. Ng earned a Juris Doctor (J.D.) degree in law from the University of Notre Dame School of Law and a Bachelor of Arts and Sciences (B.A.S.) dual degree in Biochemistry & Economics from the University of California, Davis.

    About Calidi Biotherapeutics

    Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery of oncolytic viruses for targeted therapy against difficult to treat cancers. Calidi Biotherapeutics is advancing a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. In addition, our team is developing a universal cell delivery system to house, protect, and potentiate any oncolytic viruses currently in development which can potentially enhance efficacy and improve patient safety. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

    Related Links

    http://www.calidibio.com

    Forward Looking Statement:

    Some of the statements in this press release may be forward-looking statements that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control. Calidi Biotherapeutics does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Calidi Biotherapetucs and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.

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  33. Deep Clinical-Stage Pipeline Combined With World-Class Leadership Team

    OrbiMed Advisors LLC to Lead a Concurrent Capital Raise

    9 Meters Biopharma, Inc. Will Be the New Name of the Combined NASDAQ-Listed Public Company

    Conference Call on October 7, 2019 at 8:00 a.m. EDT / 5:00 a.m. PDT

    RALEIGH, NC and TEL AVIV, ISRAEL / ACCESSWIRE / October 7, 2019 / Innovate Biopharmaceuticals, Inc. (NASDAQ:INNT), a clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases ("Innovate"), and RDD Pharma, Ltd. focused on orphan and innovative therapies for gastrointestinal disorders ("RDD"), announced today that the two companies entered into a definitive merger agreement pursuant to which Innovate…

    Deep Clinical-Stage Pipeline Combined With World-Class Leadership Team

    OrbiMed Advisors LLC to Lead a Concurrent Capital Raise

    9 Meters Biopharma, Inc. Will Be the New Name of the Combined NASDAQ-Listed Public Company

    Conference Call on October 7, 2019 at 8:00 a.m. EDT / 5:00 a.m. PDT

    RALEIGH, NC and TEL AVIV, ISRAEL / ACCESSWIRE / October 7, 2019 / Innovate Biopharmaceuticals, Inc. (NASDAQ:INNT), a clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases ("Innovate"), and RDD Pharma, Ltd. focused on orphan and innovative therapies for gastrointestinal disorders ("RDD"), announced today that the two companies entered into a definitive merger agreement pursuant to which Innovate agreed to acquire all of the outstanding capital stock of privately-held RDD in exchange for a combination of common and preferred shares. After the merger closing, Innovate will be renamed 9 Meters Biopharma, Inc. Innovate believes that the proposed transaction will position the combined company to recognize multiple value inflection points over the next 24 months based on the combined clinical pipeline, seasoned Board of Directors and world class management and prominent healthcare-dedicated institutional investors.

    "People living with gastrointestinal (GI) diseases, such as celiac disease, are waiting for treatment options," said Nissim Darvish, M.D., Ph.D., a member of the Board of Directors of RDD and Senior Managing Director of OrbiMed Advisors LLC, a lead investor in the transaction. "The proposed merger will create a powerful platform company with a pipeline of late development-stage therapeutic candidates already demonstrating proof of concept. We are excited about our investment and future involvement in this new company and the opportunities it presents."

    The combined company will focus on developing urgently needed treatments for specialty, rare and orphan patient populations with GI diseases. "With a diversified pipeline of novel compounds, active clinical studies - including the first-ever drug to enter a Phase 3 registration trial in celiac disease - 9 Meters Biopharma expects to deliver multiple value creating milestones over the next 24 months" said John Temperato, the current CEO of RDD, who will become the CEO of 9 Meters Biopharma and intends to continue to build a top talent management team of industry veterans who bring a proven track record of in-licensing, developing and commercializing multibillion-dollar assets. Mr. Temperato was instrumental in the commercial and operational buildout of Salix Pharmaceuticals for more than a decade, which culminated in Salix's acquisition for ~$16 billion in 2015.

    "The merger of Innovate and RDD to create 9 Meters Biopharma represents a bold new chapter in drug development for GI diseases and is a transformative deal for Innovate shareholders with tremendous benefits. The merger attracts a highly seasoned board and management team led by a proven CEO, fundamentally driven healthcare-dedicated institutional investors and a shared vision to build a truly world-class platform biopharmaceutical company, which can be the partner of choice for near-term business development opportunities as well, jumpstarted with an exciting clinical pipeline," said Sandeep Laumas, M.D., Executive Chairman of Innovate.

    About the Transaction

    The transaction has been approved unanimously by the Board of Directors of Innovate and RDD, and Innovate stockholders and insiders representing more than one-third of Innovate voting shares have signed voting support agreements. Pursuant to the merger agreement, Innovate will acquire all of the outstanding capital stock of RDD in exchange for the issuance of newly issued shares of Innovate common stock, representing approximately 19.5% of the voting power of Innovate as of immediately prior to the issuance of such shares, and shares of Innovate convertible preferred stock convertible into shares of Innovate common stock upon receipt of the required approval of the Innovate stockholders under Nasdaq rules. The shares of convertible preferred stock are not tradeable by the holders of the shares. Following completion of the merger, the former Innovate stockholders will own up to approximately 58.5% of the combined company's capital stock and the former RDD stockholders will own at least 41.5% of the combined company's capital stock (on a fully diluted basis). The actual allocation is subject to adjustment based on the final capital invested concurrent with the closing of the merger of up to $25 million with an initial tranche of $10 million. In connection with the merger, Innovate Biopharmaceuticals, Inc. will be renamed 9 Meters Biopharma, Inc. and is expected to continue to trade on the Nasdaq Capital Market. Closing is expected in 2019, subject to customary legal and regulatory clearances and procedures, including receipt of an Israeli tax ruling. The corporate headquarters for the combined company will be located in Raleigh, North Carolina.

    The Benchmark Company, LLC provided financial advice to the Board of Directors of Innovate with Sheppard, Mullin, Richter & Hampton LLP and Agmon & Co. Rosenberg Hacohen & Co. serving as legal counsel. Wyrick Robbins Yates & Ponton LLP and Shibolet & Co. are serving as legal counsel to RDD.

    Management and Organization

    Effective as of the closing of the merger, Mr. Temperato will become the Chief Executive Officer and join the Board of Directors of 9 Meters Biopharma, the combined company. In addition, at such time Mark Sirgo, PharmD, CEO of ArunA Bio, Inc., Vice Chairman of BioDelivery Sciences International, Inc. (NASDAQ:BDSI) and current Chairman of RDD Pharma, will become Chairman of the Board of Directors and Dr. Laumas, will continue as members of the Board of Directors of 9 Meters Biopharma. Other member of the continuing Board will include Dr. Darvish, Senior Managing Director of OrbiMed Advisors LLC and Lorin Johnson, Ph.D., co-founder of Salix Pharmaceuticals.

    Conference Call and Webcast
    Management will host a conference call at 8:00 AM today for investors regarding this announcement with details as follows:

    Conference Call and Webcast Details:
    Date: October 7, 2019
    Time: 8:00 AM EDT, 5:00 AM PDT
    Toll-free: 844-369-8770
    International: 862-298-0840
    Webcast URL: https://www.investornetwork.com/event/presentation/53994

    The archived webcast will be available on the Investors section of the Innovate website and the Investor section of the RDD website.

    About RDD Pharma

    RDD Pharma, Ltd. ("RDD"), is a privately held biopharmaceutical company focused on orphan and innovative therapies for gastrointestinal disorders. The company has two clinical stage products which serve significant unmet needs. RDD-0315 is currently in Phase 2 development for the treatment of fecal incontinence in spinal cord injury patients. RDD-0315 has received Orphan Drug status in the E.U. and Fast Track designation in the U.S. RDD-1609 is being developed for the treatment of Pruritus Ani. RDD is also exploring other potential therapies for anorectal and lower gastrointestinal disorders for future clinical development. For more information, please visit www.rddpharma.com.

    About Innovate Biopharmaceuticals, Inc.

    Innovate is a clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases. Innovate's lead drug candidate, larazotide acetate, has a mechanism of action that renormalizes the dysfunctional intestinal barrier by decreasing intestinal permeability and reducing antigen trafficking, such as gliadin fragments in celiac disease, and bacterial toxins and immunogenic antigens in NASH. In several diseases, including celiac disease, NASH, Crohn's disease, ulcerative colitis, irritable bowel syndrome (IBS), type 1 diabetes mellitus (T1DM), chronic kidney disease (CKD), the intestinal barrier is dysfunctional with increased permeability. In celiac disease, larazotide is the only drug which has successfully met the primary endpoint with statistical significance in a Phase 2b efficacy clinical trial (342 patients). Larazotide has been exposed to nearly 600 subjects in clinical trials demonstrating a favorable safety profile comparable to placebo for long-term chronic administration. Larazotide has received Fast Track designation from the FDA for celiac disease.

    Forward-Looking Statements
    This press release includes forward-looking statements based upon Innovate's and RDD's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements about the structure, timing and completion of the proposed Merger; the combined company's listing on Nasdaq after closing of the proposed Merger; expectations regarding the ownership structure of the combined company; the expected executive officers and directors of the combined company; the combined company's expected cash position at the closing of the proposed Merger; expectations regarding the financing; the future operations of the combined company; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of any product candidates of the combined company; the executive and board structure of the combined company; the location of the combined company's corporate headquarters; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; the company having sufficient resources to advance its pipeline; and other statements that are not historical fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) the risk that the conditions to the closing of the proposed Merger are not satisfied; (ii) uncertainties as to the timing of the consummation of the proposed Merger and the ability of each of Innovate and RDD to consummate the proposed Merger; (iii) risks related to Innovate's ability to manage its operating expenses and its expenses associated with the proposed Merger pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed Merger; (v) the risk that as a result of adjustments to the exchange ratio, Innovate stockholders and RDD stockholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Innovate common stock relative to the exchange ratio; (vii) unexpected costs, charges or expenses resulting from the transaction; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed Merger; (ix) the uncertainties associated with the clinical development and regulatory approval of product candidates; (x) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (xi) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (xii) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (xiii) risks associated with the possible failure to realize certain anticipated benefits of the proposed Merger, including with respect to future financial and operating results. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled "Risk Factors" in Innovate's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 filed with the SEC, and in other filings that Innovate makes and will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Innovate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    Contact:

    Innovate Biopharmaceuticals, Inc.
    Jennifer K. Zimmons, Ph.D.
    Investor Relations
    Tel: +1-917-214-3514
    Email:
    www.innovatebiopharma.com

    RDD Pharma, Ltd.
    John Temperato
    Email:
    www.rddpharma.com

    SOURCE: Innovate Biopharmaceuticals, Inc

    View source version on accesswire.com:
    https://www.accesswire.com/562128/Innovate-Biopharmaceuticals-to-Merge-with-RDD-Pharma-Creating-New-Gastroenterology-Company-Focused-on-Specialty-Rare-and-Orphan-Diseases

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  34. Major Pharmacy Benefit Manager (PBM) Improves Access for Both Products to Approximately 14 Million Lives

    Symproic Will be Listed as Preferred Exclusive and BELBUCA Preferred or Preferred Exclusive

    RALEIGH, N.C., Oct. 01, 2019 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a specialty pharmaceutical company dedicated to patients living with chronic conditions, today announced that a major PBM will begin providing improved patient access to BELBUCA® (buprenorphine buccal film), CIII, and Symproic® (naldemedine) tablets 0.2 mg beginning October 1, 2019, with full plan adoption by January 1, 2020.  This will enable approximately 14 million covered lives within both commercial and health exchange plans to access BELBUCA…

    Major Pharmacy Benefit Manager (PBM) Improves Access for Both Products to Approximately 14 Million Lives

    Symproic Will be Listed as Preferred Exclusive and BELBUCA Preferred or Preferred Exclusive

    RALEIGH, N.C., Oct. 01, 2019 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a specialty pharmaceutical company dedicated to patients living with chronic conditions, today announced that a major PBM will begin providing improved patient access to BELBUCA® (buprenorphine buccal film), CIII, and Symproic® (naldemedine) tablets 0.2 mg beginning October 1, 2019, with full plan adoption by January 1, 2020.  This will enable approximately 14 million covered lives within both commercial and health exchange plans to access BELBUCA as either the preferred or preferred exclusive buprenorphine product within their respective plans and Symproic as the preferred exclusive product within its class.  The addition of this large national PBM brings the total number of commercial lives with preferred access to BELBUCA to more than 104 million (out of more than 160 million with coverage) and more than 76 million overall