1. Expands Portfolio and Establishes Growth Platform in Neurology

    The First and Only FDA-Approved, Ready-to-Use Oral Solution for the Acute Treatment of Migraine with or without Aura in Adults

    Commercial Launch Planned for Q1 2022

    Investor Day on October 14, 2021

    RALEIGH, N.C., Sept. 09, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, announced today that it has completed the acquisition of U.S. and Canadian rights to ELYXYB™ (celecoxib oral solution) from Dr. Reddy's Laboratories Limited.

    ELYXYB is the first and only FDA-approved ready-to-use oral solution for the acute treatment…

    Expands Portfolio and Establishes Growth Platform in Neurology

    The First and Only FDA-Approved, Ready-to-Use Oral Solution for the Acute Treatment of Migraine with or without Aura in Adults

    Commercial Launch Planned for Q1 2022

    Investor Day on October 14, 2021

    RALEIGH, N.C., Sept. 09, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, announced today that it has completed the acquisition of U.S. and Canadian rights to ELYXYB™ (celecoxib oral solution) from Dr. Reddy's Laboratories Limited.

    ELYXYB is the first and only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. BDSI intends to launch ELYXYB in the first quarter of 2022. Additionally, BDSI plans to conduct an ELYXYB pediatric study, which will have the potential to address the significant unmet needs of pediatric and adolescent patients suffering from migraine attacks.

    Migraine is a debilitating condition for almost 40 million people in the U.S. Many acute migraine sufferers are searching for treatments that provide relief quickly and conveniently.

    "The availability of ELYXYB represents a significant therapeutic development for the acute treatment of migraine," stated Richard Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine, Director of the Montefiore Headache Center, and one of the clinical investigators for the ELYXYB studies. "With rapid onset of action delivered in a unique, ready-to-use oral solution, ELYXYB provides a convenient, quick relief treatment option to help patients return to functioning in their everyday lives."

    ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption1. This allows for the administration of a lower dose of drug to achieve therapeutic effect relative to a conventional oral solid dosage form. For adult patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options. ELYXYB's unit-dose oral solution makes it convenient for patients to take it immediately upon emergence of acute migraine attacks.

    "ELYXYB's pivotal studies showed that the percentage of patients achieving Most Bothersome Symptom (MBS) freedom at two hours post-dose was significantly greater for those patients receiving ELYXYB versus those receiving placebo. Study 2 demonstrated that the percentage of patients reaching headache pain freedom two hours post-dose was significantly greater for those receiving ELYXYB versus those receiving placebo. The data also showed meaningful speed of onset with Tmax achieved in approximately 60 minutes," said Thomas Smith, MD, Chief Medical Officer at BDSI, and a former thought leader in the migraine space. "BDSI looks forward to expanding our impact in Migraine and to deepening our commitment to our patients-first philosophy."

    "The acquisition of ELYXYB represents a critical step to building our presence in Neurology which is an excellent strategic adjacency to our pain franchise," said Jeff Bailey, CEO of BDSI.

    "We are confident that ELYXYB will contribute to BDSI's revenue growth and profitability over time, with patent protection until 2036. Our extensive commercial expertise, robust corporate infrastructure, and strong financial position will allow us to successfully commercialize ELYXYB and continue to pursue additional value-enhancing business development opportunities," Bailey indicated.

    BDSI will host an Investor Day on October 14, 2021, to discuss ELYXYB in further detail.

    Please see Important Safety Information about ELYXYB below.

    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 contribution of ELYXYB to the Company's revenue growth and shareholder value, the timing of commercial launch of ELYXYB, the Company's expansion into neurology, the growth of the migraine market and the significant unmet need in pediatric migraine patients 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 those set forth in our 2020 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.

    ELYXYB INDICATION AND USAGE

    ELYXYB is indicated in adults for the acute treatment of migraine with or without aura.

    Limitations of Use: ELYXYB is not indicated for the preventive treatment of migraine.

    ELYXYB IMPORTANT SAFETY INFORMATION

       
    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

       
     Cardiovascular Thrombotic Events 
       
      Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [see Warnings and Precautions (5.1)].

    ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].
       
     Gastrointestinal Bleeding, Ulceration, and Perforation 
       
      NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events [see Warnings and Precautions (5.2)].
       

    ELYXYB is contraindicated in patients with:

    • Known hypersensitivity to celecoxib, any components of the drug product, or sulfonamides (4)
    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
    • In the setting of CABG surgery (4)

    To minimize the potential risk for an adverse cardiovascular (CV) event in NSAID-treated patients, use ELYXYB for the fewest number of days per month as needed, based on individual treatment goals. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

    Avoid the use of ELYXYB in patients with a recent myocardial infarction (MI) unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ELYXYB is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

    NSAIDs, including ELYXYB, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with celecoxib. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.

    Avoid the use of ELYXYB in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If ELYXYB is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

    Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs, including ELYXYB.

    Long-term administration of NSAIDs, including celecoxib, the active ingredient in ELYXYB, has resulted in renal papillary necrosis and other renal injury.

    No information is available from controlled clinical studies regarding the use of celecoxib in patients with severe renal impairment. The renal effects of celecoxib may hasten the progression of renal dysfunction in patients with preexisting renal disease.

    Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, nonsteroidal anti-inflammatory drugs or combination of these drugs for 10 or more days per month), including ELYXYB, may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

    NSAIDs, including ELYXYB, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet drugs (e.g., aspirin), SSRIs, and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.

    Most common adverse reaction (at least 3% and greater than placebo) is dysgeusia.

    These are not all the side effects associated with ELYXYB.

    Please see Patient Information, Instructions For Use, Medication Guide and Full Prescribing Information for ELYXYB

    (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf)

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

    1 Arindam Pal, Srinivas Shenoy, Anirudh Gautam, Sagar Munjal, Jing Neu, Mathangi Gopalakrishnan & Joga Gobburru, Clinical Drug Investigation volume 37, pages 937–946(2017)

    Contact:

    Terry Coelho

    Executive Vice President & Chief Financial Officer

    BDSI_IR@bdsi.com

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989

    bob@lifesciadvisors.com



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  2. RALEIGH, N.C., Sept. 07, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, will showcase three scientific posters regarding BELBUCA® (buprenorphine buccal film), CIII at the PAINWeek 2021 Conference taking place September 7 – 11, 2021 at The Cosmopolitan of Las Vegas.

    The posters include:

    • Risk Stratification of Respiratory Depression With Buprenorphine Buccal Film Versus Oxycodone: Outcomes From a Phase 1 Placebo-Controlled Trial
      Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD
    • Buprenorphine Buccal Film Versus Oral Oxycodone: Secondary Respiratory, Pharmacokinetic, and Pupillometry

    RALEIGH, N.C., Sept. 07, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, will showcase three scientific posters regarding BELBUCA® (buprenorphine buccal film), CIII at the PAINWeek 2021 Conference taking place September 7 – 11, 2021 at The Cosmopolitan of Las Vegas.

    The posters include:

    • Risk Stratification of Respiratory Depression With Buprenorphine Buccal Film Versus Oxycodone: Outcomes From a Phase 1 Placebo-Controlled Trial

      Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD
    • Buprenorphine Buccal Film Versus Oral Oxycodone: Secondary Respiratory, Pharmacokinetic, and Pupillometry Outcomes From a Phase 1 Placebo-Controlled Trial

      Authors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD
    • Buprenorphine Buccal Film Versus Oral Oxycodone: Effects on Pupillometry and Respiratory Depression in a Phase 1 Placebo-Controlled Trial

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

    "These posters include important scientific data for healthcare professionals to consider concerning the safety profile of buprenorphine buccal film and oxycodone," said Thomas Smith, MD, Chief Medical Officer of BDSI. "We are pleased to share these data with healthcare professionals who treat chronic pain patients at this year's PAINWeek 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.

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

    Contact:

    Terry Coelho

    Chief Financial Officer

    BDSI_IR@bdsi.com 

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989

    bob@lifesciadvisors.com 



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  3. RALEIGH, N.C., Sept. 03, 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 Jeffrey Bailey, Chief Executive Officer, and Terry Coelho, Executive Vice President and Chief Financial Officer, will present and participate in one-on-one investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference taking place on September 13-15 and the Cantor Fitzgerald Global Healthcare Conference taking place on September 27-30.

    The fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference will be available to conference registrants on-demand…

    RALEIGH, N.C., Sept. 03, 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 Jeffrey Bailey, Chief Executive Officer, and Terry Coelho, Executive Vice President and Chief Financial Officer, will present and participate in one-on-one investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference taking place on September 13-15 and the Cantor Fitzgerald Global Healthcare Conference taking place on September 27-30.

    The fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference will be available to conference registrants on-demand beginning Monday, September 13, 2021, at 7:00 AM ET.

    Details for the live presentation at the Cantor Fitzgerald Global Healthcare Conference can be found below.

    Date:Tuesday, September 28, 2021
    Time:9:20 AM ET
    Format:Fireside chat
    Webcast:https://wsw.com/webcast/cantor12/bdsi/2064020

    Institutional investors interested in a one-on-one meeting with BDSI management should contact their respective H.C. Wainwright or Cantor Fitzgerald institutional sales representative.

    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

    Bob@LifeSciAdvisors.com



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  4. BOCA RATON, Fla., Aug. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, therapies for gastrointestinal (GI) diseases, today announced the appointment of Terry Coelho to its Board of Directors effective immediately. The appointment increases the size of AzurRx's Board to seven members.

    Ms. Coelho currently serves as the Executive Vice President and Chief Financial Officer at BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a commercial-stage specialty pharmaceutical company. During her more than 30-year career, Ms. Coelho has held numerous senior level financial and operational positions at both emerging and publicly-traded…

    BOCA RATON, Fla., Aug. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, therapies for gastrointestinal (GI) diseases, today announced the appointment of Terry Coelho to its Board of Directors effective immediately. The appointment increases the size of AzurRx's Board to seven members.

    Ms. Coelho currently serves as the Executive Vice President and Chief Financial Officer at BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a commercial-stage specialty pharmaceutical company. During her more than 30-year career, Ms. Coelho has held numerous senior level financial and operational positions at both emerging and publicly-traded, global companies, highlighted by tenures with leading global organizations including Novartis Pharmaceuticals, Mars, Incorporated, Sealed Air Corporation, and Diversey, Inc.

    "Adding an individual of Terry's talent and extensive executive experience to AzurRx's Board of Directors is an achievement for our company and our shareholders," said James Sapirstein, Chairman, President and CEO of AzurRx. "Terry brings to AzurRx unrivaled financial and operational experience, which will be critical to our growth and long-term success. On behalf of the Board, I am pleased to welcome Terry to AzurRx and look forward to benefitting from her knowledge and expertise."

    Ms. Coelho joined BioDelivery Sciences in January 2019 and previously served as the Chief Financial Officer and Treasurer. Prior to her tenure at BioDelivery Sciences, Ms. Coelho served as Chief Financial Officer and Treasurer at Balchem Corporation (NASDAQ:BCPC) from October 2017 to October 2018. From September 2017 to October 2017, she served as Chief Operating Officer for Diversey, Inc., a multibillion-dollar global private equity carve-out from Sealed Air, and held senior finance positions at Diversey Care from October 2014 through August 2017, including as Chief Financial Officer for Diversey Care. Ms. Coelho has also served in other senior finance leadership roles, including Global Head of Oncology Development Finance at Novartis from 2007 to 2014. Ms. Coelho earned an MBA in Finance from IBMEC in Brazil and Bachelor of Arts degrees in Economics and International Relations, summa cum laude, from The American University School of International Service in Washington, DC. She has led Women's Networking ERGs and is a founding Steering Committee Member of the CFO Leadership Council – Charlotte chapter.

    "I am honored to be joining the Board of AzurRx BioPharma," said Ms. Coelho. "My goal is to utilize my extensive financial background in both pharma and other industries to help AzurRx achieve its full growth potential. Both shareholders and patients have the opportunity to benefit from what I believe to be important therapeutic advancements being developed by AzurRx for the treatment of COVID-19 related GI disease, Immune Checkpoint Inhibitor-associated colitis, and exocrine pancreatic insufficiency."

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of two gut-restricted GI assets in three clinical indications. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a small molecule with anti-viral and anti-inflammatory properties: FW-1022, for COVID-19 gastrointestinal infections and FW-420, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced stage oncology patients. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.

    Forward-Looking Statement

    This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including risks and uncertainties related to market conditions; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company's drug candidates and its ability to service those markets; and the Company's current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    777 Yamato Road, Suite 502

    Boca Raton, FL 33431

    Phone: (561) 589-7020

    info@azurrx.com

    Media contact:

    Tiberend Strategic Advisors, Inc.

    Johanna Bennett / David Schemelia

    (212) 375-2665 / (609) 468-9325

    jbennett@tiberend.com / dschemelia@tiberend.com



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  5. Total Company Net Revenue of $41.4 Million Driven by BELBUCA® All-Time High TRx Market Share

    Strong Profitability with GAAP Net Income of $9.1 Million, or $0.09 per share, EBITDA Margin of 32%, and Non-GAAP Net Income of $12.5 Million, or $0.12 per Share, Drives Operating Cash Generation of $9.2 Million

    Announces Agreement to Acquire ELYXYB TM for the Acute Treatment of Migraine

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

    RALEIGH, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a 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, 2021…

    Total Company Net Revenue of $41.4 Million Driven by BELBUCA® All-Time High TRx Market Share

    Strong Profitability with GAAP Net Income of $9.1 Million, or $0.09 per share, EBITDA Margin of 32%, and Non-GAAP Net Income of $12.5 Million, or $0.12 per Share, Drives Operating Cash Generation of $9.2 Million

    Announces Agreement to Acquire ELYXYB TM for the Acute Treatment of Migraine

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

    RALEIGH, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a 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, 2021, including the following operational and performance highlights.

    "BELBUCA continued its strong double-digit revenue growth trajectory in spite of a slower-than-expected rebound in the pain market, however, we are starting to see gradual signs of market normalization," stated Jeff Bailey, CEO of BDSI. "I am proud of the team and our ability to effectively manage the overall business, delivering an attractive 32% EBITDA margin in the quarter."

    "We are also very pleased to be adding ELYXYB to our portfolio of valuable and differentiated products, as the only ready-to-use oral solution approved for acute migraine with or without aura in adults," Bailey added. "This differentiated drug represents a highly attractive opportunity to diversify our product portfolio, deepening our presence in neurology, a logical adjacency to our chronic pain franchise. We see this acquisition as establishing a great growth platform in neurology."

    Key Business Highlights

    • Total Company net revenue for the second quarter increased by 13% versus the prior year period to $41.4 million. This growth was driven by all-time high BELBUCA net sales of $36.5 million, which increased 13% year over year, and Symproic® net sales of $4.0 million, which increased 18% year over year.
    • BELBUCA achieved an all-time high quarterly market share of 4.7% as well as an all- time high in unique BELBUCA prescribers of 8,345 which is an increase of 11% year over year. Total BELBUCA prescriptions were approximately 119,000 during the second quarter, representing year-over-year prescription volume growth of 11%.
    • Total Symproic prescriptions were approximately 18,000 in the second quarter, up 3% versus the prior year period.
    • Strong gross margin of 89.7%, coupled with prudent management and prioritization of operating expenses, contributed to continued strong profitability, with $9.1 million of GAAP Net Income, an attractive 32% EBITDA margin, and non-GAAP Net Income of $12.5 million or $0.12 cents per share in the second quarter of 2021. Year-to-date through June 30, 2021, non-GAAP Net Income is $21.0 million or $0.20 cents per share. Both GAAP and non-GAAP net income were impacted by higher litigation spend year to date through June 30, 2021.
    • On August 3, 2021, the Company entered into an agreement to acquire the U.S. and Canadian rights to ELYXYB (celecoxib oral solution), from Dr. Reddy's Laboratories. ELYXYB is the only ready-to-use oral solution approved by the FDA for the acute treatment of migraine, with or without aura, in adults. When launched in the US, ELYXYB will participate in a substantial and growing market, and is expected to drive the Company's revenue growth and shareholder value while leveraging much of its existing infrastructure.
    • The Company repurchased 1.6 million shares in the quarter under its existing share buyback program, at an average price of $3.51 per share, bringing the total shares purchased to date under the program to 3.3 million shares, at an average price of $3.70.

    Second Quarter 2021 Financial Results

    Total Company Net Revenue for the second quarter of 2021 was $41.4 million, an increase of 13% compared to $36.6 million in the second quarter of 2020. Total product net revenue, including sales of BELBUCA and Symproic, grew 11% year over year.

    BELBUCA Net Sales for the second quarter of 2021 were an all-time high of $36.5 million, an increase of 13% compared to $32.3 million in the second quarter of 2020.  

    Symproic Net Sales for the second quarter were $4.0 million, an increase of 18% compared to $3.4 million in the second quarter of 2020.

    Total Operating Expenses for the second quarter of 2021 were $25.8 million, compared to $28.2 million in the second quarter of 2020.

    GAAP Net Income for the second quarter of 2021 was $9.1 million, or $0.09 per share, compared to GAAP net income of $1.2 million, or $0.01 per share, in the second quarter of 2020.

    EBITDA for the second quarter of 2021 was $13.1 million, or 32% of net sales, compared to $5.1 million or 14% of net sales, in the second quarter of 2020.

    Non-GAAP Net Income for the second quarter of 2021 was $12.5 million, or $0.12 cents per share, and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets, as compared to non-GAAP net income of $9.6 million, or $0.10 cents per share, in the second quarter of 2020, excluding the same items as well as the one-time costs associated with the CEO transition in that period.

    Cash Position: As of June 30, 2021, cash and cash equivalents were approximately $119.9 million, compared to $111.6 million as of December 31, 2020. The total cash flow generation year to date of $8.3 million includes continued strong operating cash generation of $20.3 million, partially offset by $11.9 million used to repurchase shares.

    Financial Guidance

    The Company reiterates its 2021 financial guidance, with full year 2021 total Company net sales of $170 - $180 million, including full year 2021 BELBUCA net sales of $155 - $165 million. However, due to a slower than anticipated rebound in the chronic pain selling environment associated with the COVID-19 pandemic, the Company expects BELBUCA net sales to be at the lower end of its prior guidance range. Total operating expenses are expected to be in the range of $115 - $120 million for the ongoing business, as the Company continues to invest to support the growth of its existing brands. Additionally, EBITDA remains on track to be in the $40 - $50 million range 2021 for the ongoing business. The Company continues to expect to deliver positive operating cash flow in 2021. The Company will share any updates to its guidance as a result of the ELYXYB acquisition at a future date.

    "We continue to invest behind our growing brands and infrastructure to drive future growth. The persistent efforts of our commercial team permit us to continue growing our market share for BELBUCA within the long-acting opioid market. Our focus remains on helping patients with unmet needs and driving long-term shareholder value through our pain and now neurology franchises," stated Jeff Bailey.  

    Please see Important Safety Information about ELYXYB below.

    Conference Call & Webcast Details

    BioDelivery Sciences will host a conference call and webcast today, August 4, 2021, at 8:30 a.m. ET to present second quarter 2021 results and to provide a business update.  Dial-in details are as follows:

    Date:Wednesday, August 4, 2021
    Time:8:30 AM Eastern Time
    Domestic:877-407-0789
    International:201-689-8562
    Conference ID:13720500
    Webcast:http://public.viavid.com/index.php?id=145242



    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 expectations for total company net sales, BELBUCA net sales, operating expenses, EBITDA and operating cash flows in 2021, the acquisition and launch of ELYXYB and growth in neurology) 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 2020 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 and non-cash amortization of intangible assets, as well as one-time costs associated with the CEO transition in the second quarter of 2020 and the non-recurring impact of the discontinuation of BUNAVAIL.

    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.

    ELYXYB INDICATION AND USAGE

    ELYXYB is indicated in adults for the acute treatment of migraine with or without aura.

    Limitations of Use: ELYXYB is not indicated for the preventive treatment of migraine.

    ELYXYB IMPORTANT SAFETY INFORMATION



    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS



    Cardiovascular Thrombotic Events

    • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [see Warnings and Precautions (5.1)].
    • ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].
    Gastrointestinal Bleeding, Ulceration, and Perforation
    • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events [see Warnings and Precautions (5.2)].

    ELYXYB is contraindicated in patients with:

    • Known hypersensitivity to celecoxib, any components of the drug product, or sulfonamides (4)
    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
    • In the setting of CABG surgery (4)

    To minimize the potential risk for an adverse cardiovascular (CV) event in NSAID-treated patients, use ELYXYB for the fewest number of days per month as needed, based on individual treatment goals. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

    Avoid the use of ELYXYB in patients with a recent myocardial infarction (MI) unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ELYXYB is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

    NSAIDs, including ELYXYB, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with celecoxib. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.

    Avoid the use of ELYXYB in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If ELYXYB is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

    Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs, including ELYXYB.

    Long-term administration of NSAIDs, including celecoxib, the active ingredient in ELYXYB, has resulted in renal papillary necrosis and other renal injury.

    No information is available from controlled clinical studies regarding the use of celecoxib in patients with severe renal impairment. The renal effects of celecoxib may hasten the progression of renal dysfunction in patients with preexisting renal disease.

    Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, nonsteroidal anti-inflammatory drugs or combination of these drugs for 10 or more days per month), including ELYXYB, may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

    NSAIDs, including ELYXYB, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet drugs (e.g., aspirin), SSRIs, and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.

    Most common adverse reaction (at least 3% and greater than placebo) is dysgeusia.

    These are not all the side effects associated with ELYXYB.

    Please see Patient Information, Instructions For Use, Medication Guide and Full Prescribing Information for ELYXYB

    (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf)

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

    Contact:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Bob@LifeSciAdvisors.com





    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
    (Unaudited)
     
     June 30,

    2021
     December 31,

    2020
    ASSETS   
    Current assets:   
    Cash and cash equivalents$119,853  $111,584 
    Accounts receivable, net52,872  48,150 
    Inventory, net18,659  17,443 
    Prepaid expenses and other current assets4,680  5,208 
    Total current assets196,064  182,385 
    Property and equipment, net1,640  1,418 
    Goodwill2,715  2,715 
    License and distribution rights, net49,908  53,376 
    Total assets$250,327  $239,894 
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable and accrued liabilities$57,752  $52,995 
    Notes payable, current6,154   
    Total current liabilities63,906  52,995 
    Notes payable, less current maturities72,472  78,452 
    Other long-term liabilities31  213 
    Total liabilities136,409  131,660 
    Commitments and contingencies   
    Stockholders' equity:   
    Preferred Stock, 5,000,000 shares authorized; Series B Non-Voting Convertible

    Preferred Stock, $0.001 par value, 443 shares outstanding at June 30, 2021 and

    December 31, 2020, respectively.
       
    Common Stock, $0.001 par value; 235,000,000 shares authorized at June 30, 2021

    and December 31, 2020, respectively; 101,794,730 and 101,417,441 shares issued;

    98,529,046 and 101,354,447 shares outstanding at June 30, 2021 and December 31,

    2020, respectively.
    104  104 
    Additional paid-in capital452,550  449,264 
    Treasury stock, at cost, 3,265,684 and 62,994 shares, as of June 30, 2021 and

    December 31, 2020, respectively.
    (12,155) (252)
    Accumulated deficit(326,581) (340,882)
    Total stockholders' equity113,918  108,234 
    Total liabilities and stockholders' equity$250,327  $239,894 





    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,
     2021 2020 2021 2020
    Revenues:       
    Product sales$40,523  $36,445  $81,326  $74,161 
    Product royalty revenues916  137  1,132  700 
           Total revenues:41,439  36,582  82,458  74,861 
    Cost of sales4,284  5,435  10,105  10,995 
    Expenses:       
    Selling, general and administrative25,779  28,211  53,540  54,948 
           Total expenses:25,779  28,211  53,540  54,948 
    Income from operations11,376   2,936  18,813  8,918 
    Interest expense, net(1,999) (1,693) (3,977) (2,987)
    Other (expense)/income, net(1) 8  (1) 8 
    Income before income taxes$9,376  $1,251  $14,835  $5,939 
    Income tax (provision)/recovery(312) (86) (534) 192 
    Net income attributable to common

    stockholders
    $9,064  $1,165  $14,301  $6,131 
    Basic       
    Weighted average common stock shares

    outstanding
    98,793,242  100,136,893  99,884,680  98,541,877 
    Basic earnings per share$0.09  $0.01  $0.14  $0.06 
    Diluted       
    Weighted average common stock shares

    outstanding
    102,508,512  108,111,201  104,009,410  107,062,161 
    Diluted earnings per share$0.09  $0.01  $0.14  $0.06 





    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    (U.S. DOLLARS, IN THOUSANDS)
    (Unaudited)
     
     Six months ended June 30,
     2021 2020
    Operating activities:   
    Net income$14,301  $6,131 
    Adjustments to reconcile net income to net cash flows from operating

    activities
       
           Depreciation and amortization54  446 
           Accretion of debt discount and loan costs174  142 
           Amortization of intangible assets3,469  3,515 
           Provision for inventory obsolescence699  72 
           Stock-based compensation expense3,187  6,306 
           Net change in operating lease assets and liabilities(19)  
    Changes in assets and liabilities:   
           Accounts receivable(4,722) (9,336)
           Inventories(1,915) (6,534)
           Prepaid expenses and other assets368  1,670 
           Accounts payable and accrued liabilities4,731  2,617 
           Taxes payable  (40)
    Net cash flows provided by operating activities20,327  4,989 
    Investing activities:   
           Acquisitions of equipment(415)  
    Net cash flows used in investing activities(415)  
    Financing activities:   
    Proceeds from notes payable  20,000 
    Proceeds from exercise of stock options260  2,569 
    Payment on share repurchase(11,903)  
    Payment on deferred financing fees  (437)
    Net cash flows (used in)/provided by financing activities(11,643) 22,132 
    Net change in cash and cash equivalents8,269  27,121 
    Cash and cash equivalents at beginning of period111,584  63,888 
    Cash and cash equivalents at end of period$119,853  $91,009 





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

    June 30,
     Six Months Ended

    June 30,
    Reconciliation of GAAP net income to EBITDA (non-GAAP)  2021 2020   2021 2020
    GAAP net income$9,064 $1,165  $14,301 $6,131 
    Add back/(subtract):     
    Income tax recovery/(provision) 312  86   534  (192)
    Net interest expense 1,999  1,685   3,977  2,979 
    Depreciation and amortization 1,769  2,159   3,523  3,960 
    EBITDA$13,144 $5,095  $22,335 $12,878 
    Reconciliation of GAAP net income to Non-GAAP net income     
    GAAP net income$9,064

     $1,165

     $14,301

     $6,131

     
    Non-GAAP adjustments:     
    Stock-based compensation expense 1,697  1,364   3,187  2,884 
    Amortization of intangible assets 1,735  1,734   3,469  3,515 
    Non-recurring financial impact of CEO transition   5,078     5,078 
    Non-recurring financial impact of BUNAVAIL discontinuation   295     295 
    Non-GAAP net income$12,496 $9,636  $20,957 $17,903 


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  6. The only FDA-approved, ready-to-use oral solution for the acute treatment of migraine with or without aura in adults

    First step to building a growth platform in Neurology

    Patent protection until 2036

    RALEIGH, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, announced today that it entered into an agreement on August 3, 2021 with Dr. Reddy's Laboratories Limited to acquire the U.S. and Canadian rights to ELYXYB (celecoxib oral solution), the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.

    "ELYXYB represents an…

    The only FDA-approved, ready-to-use oral solution for the acute treatment of migraine with or without aura in adults

    First step to building a growth platform in Neurology

    Patent protection until 2036

    RALEIGH, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, announced today that it entered into an agreement on August 3, 2021 with Dr. Reddy's Laboratories Limited to acquire the U.S. and Canadian rights to ELYXYB (celecoxib oral solution), the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.

    "ELYXYB represents an excellent strategic fit for BDSI and a very attractive opportunity to diversify our product portfolio by expanding into the dynamic migraine market, deepening our presence in Neurology, a logical adjacency to our pain franchise," stated Jeff Bailey, CEO of BDSI.

    "ELYXYB will contribute nicely to the Company's revenue growth and profitability over time. This transaction leverages our commercial expertise and much of our existing infrastructure. We see this acquisition as establishing a great growth platform in Neurology. Further, the deal structure is attractive, allowing us to maintain our strong balance sheet and position us to pursue additional value-enhancing business development opportunities," Bailey concluded.

    ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption1. This allows for the administration of a lower dose of drug to achieve therapeutic effect relative to a conventional oral solid dosage form. In pivotal studies, ELYXYB demonstrated a rapid onset of action which is critically important to patients suffering from acute migraine attacks. The results from pivotal studies established the efficacy of ELYXYB in the treatment of acute migraine. For adult patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options. ELYXYB's unit-dose oral solution makes it convenient for patients to take it immediately upon emergence of acute migraine attacks.

    With over 13 million migraine patients receiving prescription drug treatment in the U.S. in 2020, the dynamic migraine market continues to grow and evolve, including with new product introductions. BDSI will be conducting an ELYXYB pediatric study which has the potential to address the significant unmet need in the pediatric patient population.

    Under the terms of the agreement, ELYXYB will be acquired for an upfront payment of $6 million, plus an additional $9 million on August 3, 2022. BDSI will make tiered quarterly earn-out payments on potential net sales ranging from the high single digits to the low double digits. Additional payments will be made contingent upon the achievement of certain regulatory and sales milestones. The impact of the acquisition is estimated to be cash flow accretive within approximately 24 months of commercial launch, currently planned for Q1 2022. The closing of the transaction is subject to satisfactory completion of customary closing conditions, including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).

    "We are excited to acquire ELYXYB," said Thomas Smith, MD, Chief Medical Officer at BDSI, and a former thought leader in the migraine space with over 30 years of experience both as a physician and with multiple migraine product developments and launches. The clinical data are quite compelling, including a meaningful speed of onset with Tmax achieved in approximately 60 minutes. Additionally, in the two pivotal studies conducted, the percentage of patients achieving Most Bothersome Symptom (MBS) freedom at two hours post-dose was significantly greater among patients receiving ELYXYB, compared to those receiving placebo. In Study 2, the percentage of patients achieving headache pain freedom two hours post-dose was significantly greater among patients receiving ELYXYB, compared to those receiving placebo. We believe that this profile, coupled with the ready-to-use oral solution, make ELYXYB an attractive option for the acute treatment of migraine in adults."

    The Company plans to conduct a BDSI investor day early in the fourth quarter, where further details regarding ELYXYB will be shared.

    Please see Important Safety Information about ELYXYB below.

    ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.

    BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with serious and complex 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 closing of the acquisition of ELYXYB, the contribution of ELYXYB to the Company's revenue growth and shareholder value, the timing of commercial launch of ELYXYB, the Company's expansion into neurology, the growth of the migraine market and the significant unmet need in pediatric migraine patients 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 those set forth in our 2020 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.

    ELYXYB INDICATION AND USAGE

    ELYXYB is indicated in adults for the acute treatment of migraine with or without aura.

    Limitations of Use: ELYXYB is not indicated for the preventive treatment of migraine.

    ELYXYB IMPORTANT SAFETY INFORMATION



                                                                                                                              WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS



     Cardiovascular Thrombotic Events

    • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [see Warnings and Precautions (5.1)].
    • ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].
     Gastrointestinal Bleeding, Ulceration, and Perforation
    • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events [see Warnings and Precautions (5.2)].

    ELYXYB is contraindicated in patients with:

    • Known hypersensitivity to celecoxib, any components of the drug product, or sulfonamides (4)
    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
    • In the setting of CABG surgery (4)

    To minimize the potential risk for an adverse cardiovascular (CV) event in NSAID-treated patients, use ELYXYB for the fewest number of days per month as needed, based on individual treatment goals. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

    Avoid the use of ELYXYB in patients with a recent myocardial infarction (MI) unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ELYXYB is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

    NSAIDs, including ELYXYB, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with celecoxib. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.

    Avoid the use of ELYXYB in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If ELYXYB is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

    Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs, including ELYXYB.

    Long-term administration of NSAIDs, including celecoxib, the active ingredient in ELYXYB, has resulted in renal papillary necrosis and other renal injury.

    No information is available from controlled clinical studies regarding the use of celecoxib in patients with severe renal impairment. The renal effects of celecoxib may hasten the progression of renal dysfunction in patients with preexisting renal disease.

    Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, nonsteroidal anti-inflammatory drugs or combination of these drugs for 10 or more days per month), including ELYXYB, may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

    NSAIDs, including ELYXYB, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet drugs (e.g., aspirin), SSRIs, and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.

    Most common adverse reaction (at least 3% and greater than placebo) is dysgeusia.

    These are not all the side effects associated with ELYXYB.

    Please see Patient Information, Instructions For Use, Medication Guide and Full Prescribing Information for ELYXYB

    (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf)

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

    Arindam Pal, Srinivas Shenoy, Anirudh Gautam, Sagar Munjal, Jing Niu, Mathangi Gopalakrishnan & Joga Gobburru, Clinical Drug Investigation volume 37, pages 937–946(2017)

    Contacts:

    Terry Coelho

    Executive Vice President & Chief Financial Officer

    BDSI_IR@bdsi.com

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Bob@LifeSciAdvisors.com



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  7. RALEIGH, N.C., July 22, 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 second quarter 2021 financial results before the open of the U.S. financial markets on Wednesday, August 4, 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, August 4, 2021
    Time:8:30 AM Eastern Time
    Domestic:877-407-0789
    International:201-689-8562
    Conference ID:13720500
    Webcast:http://public.viavid.com/index.php?id=145242

    RALEIGH, N.C., July 22, 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 second quarter 2021 financial results before the open of the U.S. financial markets on Wednesday, August 4, 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, August 4, 2021
    Time:8:30 AM Eastern Time
    Domestic:877-407-0789
    International:201-689-8562
    Conference ID:13720500
    Webcast:http://public.viavid.com/index.php?id=145242

    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

    Bob@LifeSciAdvisors.com



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  8. Total Company Net Revenue of $41 Million, an Increase of 7% versus Prior Year

    Net Income of $5.2 Million, EBITDA Margin of 22% and Operating Cash Generation of $11 Million

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

    RALEIGH, N.C., May 06, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a 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, 2021, including the following operational and performance highlights.

    Key Business Highlights

    • Total Company net revenue for the first quarter increased by 7% versus the prior year period to $41.0 million. This growth…

    Total Company Net Revenue of $41 Million, an Increase of 7% versus Prior Year



    Net Income of $5.2 Million, EBITDA Margin of 22% and Operating Cash Generation of $11 Million



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

    RALEIGH, N.C., May 06, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a 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, 2021, including the following operational and performance highlights.

    Key Business Highlights

    • Total Company net revenue for the first quarter increased by 7% versus the prior year period to $41.0 million. This growth was driven by BELBUCA® net sales of $36.4 million, which increased 9%, and Symproic® net sales of $4.4 million, which increased 5%.
    • BELBUCA continued to deliver an all-time high quarterly market share, despite pandemic challenges and the impact of winter storm Uri. Total BELBUCA prescriptions were approximately 113,000 during the first quarter, representing year-over-year prescription volume growth of 9%.
    • Total Symproic prescriptions were approximately 17,000 in the first quarter, consistent with prescriptions for the prior year period.
    • Continued to achieve strong profitability, delivering $5.2 million of GAAP Net Income and an attractive 22% EBITDA margin in the first quarter of 2021.
    • The Company repurchased 1.6 million shares in the quarter under its share buyback program, at an average price of $3.87 per share.

    "We again delivered solid top and bottom-line growth in a challenging quarter against the backdrop of the pandemic and weather-related disruptions, resulting in 22% EBITDA margin and $11 million operating cash flow generation," stated Jeff Bailey, CEO of BDSI. "Our performance highlights the strength of our commercial team and the persistent market demand for our highly differentiated products. We expect continued success as the selling environment improves throughout the year, including increases of in-office patient visits and more face-to-face interactions with health care providers by our sales representatives."

    First Quarter 2021 Financial Results

    Total Company Net Revenue for the first quarter of 2021 was $41.0 million, an increase of 7% compared to $38.3 million in the first quarter of 2020. Total product net revenue, including sales of BELBUCA and Symproic, grew 8% year over year. Severe winter weather conditions, especially in the South-Central region where the Company has strong market presence, affected patients' access to their physicians and pharmacies. Additionally, the severe weather delayed shipments of the Company's products to pharmacy distribution centers of the major wholesalers.

    BELBUCA Net Sales for the first quarter of 2021 were $36.4 million, an increase of 9% compared to $33.5 million in the first quarter of 2020. As we typically experience each year, BELBUCA gross to net deductions were lower in the first quarter, largely due to the Medicare coverage gap impact.

    Symproic Net Sales for the first quarter were $4.4 million, an increase of 5% compared to $4.2 million in the first quarter of 2020. Symproic net sales benefited from reduced gross to net deductions in the first quarter due to the typical decreases seen for Medicare coverage gap, as well as updates to our gross to net deductions related to channel estimates.

    Total Operating Expenses for the first quarter of 2021 were $27.8 million, compared to $26.7 million in the first quarter of 2020. The increase in spending as compared to fourth quarter of 2020 was driven by increased investments in sales and marketing and $3.0 million higher legal spend in the quarter, primarily due to costs associated with the Paragraph IV patent litigation.

    GAAP Net Income for the first quarter of 2021 was $5.2 million, or $0.05 per share, compared to GAAP net income of $5.0 million, or $0.05 per share, in the first quarter of 2020.

    EBITDA for the first quarter of 2021 was $9.2 million, or 22% of net sales, compared to $7.8 million or 20% of net sales, in the first quarter of 2020.

    Non-GAAP Net Income for the first quarter of 2021 was $8.5 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets as compared to non-GAAP net income of $8.3 million in the first quarter of 2020, excluding the same items

    Cash Position: As of March 31, 2021, cash and cash equivalents were approximately $116.4 million, compared to $111.6 million as of December 31, 2020. The total cash flow generation over the quarter of $4.9 million includes continued strong operating cash generation of $11.1 million, partially offset by $6.1 million used to repurchase shares in the quarter.

    Financial Guidance

    The Company reiterates its 2021 financial guidance, with full year 2021 total Company net sales of $170 - $180 million, including full year 2021 BELBUCA net sales of $155 - $165 million. Total operating expenses are expected to be in the range of $115 - $120 million, as the Company continues to invest to support the growth of its brands, and EBITDA is expected to be in the range of $40 - $50 million in 2021. The Company expects to continue delivering positive operating cash flow throughout 2021.

    "Our confidence in the continued growth of our brands and the profitability of our business remains unchanged. This is demonstrated by our continuing investments behind our portfolio, together with the share repurchase program which is underway. We remain on track to drive long-term shareholder value, and are actively considering potential business development opportunities," stated Jeff Bailey.  

    Conference Call & Webcast Details

    BioDelivery Sciences will host a conference call and webcast today, May 6, 2021, at 8:30 a.m. ET to present first quarter 2021 results and to provide a business update.  Dial-in details are as follows:

    Date: Thursday, May 6, 2021
    Time:8:30 AM Eastern Time
    Domestic:877-407-0789
    International:201-689-8562
    Conference ID:13718097
    Webcast:http://public.viavid.com/index.php?id=144116

    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 expectations for total company net sales, BELBUCA net sales, operating expenses, EBITDA and operating cash flows in 2021) 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 2020 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 and non-cash amortization of intangible assets.

    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.

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

    Contact:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Bob@LifeSciAdvisors.com

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

     (Unaudited)

     March 31,

    2021
     December 31,

    2020
    ASSETS   
    Current assets:   
    Cash and cash equivalents$116,436   $111,584  
    Accounts receivable, net48,294   48,150  
    Inventory, net16,968   17,443  
    Prepaid expenses and other current assets4,449   5,208  
    Total current assets186,147   182,385  
    Property and equipment, net1,626   1,418  
    Goodwill2,715   2,715  
    License and distribution rights, net51,642   53,376  
    Total assets$242,130    $239,894   
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable and accrued liabilities$54,584   $52,995  
    Total current liabilities54,584   52,995  
    Notes payable, net78,538   78,452  
    Other long-term liabilities154   213  
    Total liabilities133,276   131,660  
    Commitments and contingencies   
    Stockholders' equity:   
    Preferred Stock, 5,000,000 shares authorized; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 shares outstanding at March 31, 2021 and December 31, 2020, respectively.     
    Common Stock, $.001 par value; 235,000,000 shares authorized at March 31, 2021 and December 31, 2020, respectively; 101,702,234 and 101,417,441 shares issued;100,061,096 and 101,354,447 shares outstanding at March 31, 2021 and December 31, 2020, respectively.104   104  
    Additional paid-in capital450,794   449,264  
    Treasury stock, at cost, 1,641,138 and 62,994 shares as of March 31, 2021 and December 31, 2020, respectively(6,399)  (252) 
    Accumulated deficit(335,645)  (340,882) 
    Total stockholders' equity108,854   108,234  
    Total liabilities and stockholders' equity$242,130    $239,894   
              



    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,
     2021 2020
    Revenues:   
    Product sales, net$40,804   $37,715  
    Product royalty revenues216   563  
    Total Revenues:41,020   38,278  
    Cost of sales5,821   5,560  
    Expenses:   
    Selling, general and administrative27,761   26,736  
    Total Expenses:27,761   26,736  
    Income from operations7,438   5,982  
    Interest expense, net(1,979)  (1,293) 
    Other expense, net   (1) 
    Income before income taxes$5,459   $4,688  
    Income tax provision(222)  278  
    Net income attributable to common stockholders$5,237    $4,966   
    Basic   
    Weighted average common stock shares outstanding100,988,245   97,118,267  
    Basic earnings per share$0.05   $0.05  
    Diluted   
    Weighted average common stock shares outstanding105,396,793   106,965,762  
    Diluted earnings per share$0.05    $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,
     2021 2020
    Operating activities:   
    Net income$5,237    $4,966   
    Adjustments to reconcile net income to net cash flows from operating activities   
    Depreciation19   21  
    Accretion of debt discount and loan costs86   65  
    Amortization of intangible assets1,735   1,781  
    Provision for inventory obsolescence369   405  
    Stock-based compensation expense1,490   1,520  
    Changes in assets and liabilities:   
    Accounts receivable(144)  (6,324) 
    Inventories106   (4,096) 
    Prepaid expenses and other assets602   1,169  
    Accounts payable and accrued liabilities1,597   6,920  
    Taxes payable   (40) 
    Net cash flows provided by operating activities11,097    6,387   
    Investing activities:   
    Purchase of equipment(296)    
    Net cash flows used in investing activities(296)    
    Financing activities:   
    Proceeds from exercise of stock options198   338  
    Payment on share repurchase(6,147)    
    Net cash flows (used in) provided by financing activities(5,949)  338  
    Net change in cash and cash equivalents4,852   6,725  
    Cash and cash equivalents at beginning of period111,584   63,888  
    Cash and cash equivalents at end of year$116,436    $70,613   
              



    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES


    RECONCILIATION OF NON-GAAP METRICS

    (U.S. DOLLARS, IN THOUSANDS)

    (Unaudited)

      Three Months Ended,
    Reconciliation of GAAP net income to EBITDA (non-GAAP)  March 31, 2021December 31, 2020March 31, 2020
    GAAP net income $5,237  $10,197  4,966   
    Add back/(subtract):    
    Income tax provision 222  233  (278) 
    Net interest expense 1,979  2,022  1,294   
    Depreciation and amortization 1,753  1,806  1,802   
    EBITDA $9,191  $14,258  $7,784   
    Reconciliation of GAAP net income to Non-GAAP net income    
    GAAP net income 5,237  10,197  4,966   
    Non-GAAP adjustments:    
    Stock-based compensation expense 1,490  1,750  1,520   
    Amortization of intangible assets 1,735  1,733  1,781   
    Non-GAAP net income $8,462  $13,680  $8,267   
                


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  9. RALEIGH, N.C., April 20, 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 first quarter 2021 financial results before the open of the U.S. financial markets on Thursday, May 6, 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: Thursday, May 6, 2021
     Time:8:30 AM Eastern Time
     Domestic:877-407-0789
     International:201-689-8562
     Conference ID:13718097
     Webcast:http://public.viavid.com/index.php?id=144116

    RALEIGH, N.C., April 20, 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 first quarter 2021 financial results before the open of the U.S. financial markets on Thursday, May 6, 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: Thursday, May 6, 2021
     Time:8:30 AM Eastern Time
     Domestic:877-407-0789
     International:201-689-8562
     Conference ID:13718097
     Webcast:http://public.viavid.com/index.php?id=144116

    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

    Bob@LifeSciAdvisors.com

     



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  10. Total Company Net Revenue Increased 40% versus Prior Year to Reach an All-Time High of $156.5 Million

    Record Level Profitability with Net Income of $25.7 Million, Full-Year EBITDA Margin of 26% and Operating Cash Generation of $25 Million

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

    RALEIGH, N.C., March 10, 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 reported strong financial results for the fourth quarter and full-year ended December 31, 2020, as well as the following operational and performance highlights.

    Key Business Highlights

    • Total Company full-year…

    Total Company Net Revenue Increased 40% versus Prior Year to Reach an All-Time High of $156.5 Million

    Record Level Profitability with Net Income of $25.7 Million, Full-Year EBITDA Margin of 26% and Operating Cash Generation of $25 Million

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

    RALEIGH, N.C., March 10, 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 reported strong financial results for the fourth quarter and full-year ended December 31, 2020, as well as the following operational and performance highlights.

    Key Business Highlights

    • Total Company full-year net revenue of $156.5 million delivered growth of 40% versus 2019 mainly driven by BELBUCA® (buprenorphine buccal film) CIII net sales of $136.1 million, an increase of 40% compared to 2019, and Symproic® (naldemedine) net sales of $14.7 million in 2020, an increase of 83% over 2019.
    • Total Company net revenue for the fourth quarter increased by 33% versus the prior year period to $42.2 million. This growth was driven by BELBUCA net sales of $35.6 million, an increase of 26% versus the prior year period, and Symproic net sales of $3.7 million, an increase of 35% compared to the fourth quarter of 2019.
    • BELBUCA reached all-time high prescription volume and market share, with total BELBUCA prescriptions of close to 119,000 during the fourth quarter, representing year-over-year prescription volume growth of 21%.
    • Symproic reached all-time high prescription volume and market share, with total Symproic prescriptions of close to 19,000 in the fourth quarter, representing growth of 10% versus the prior year.
    • Achieved significant profitability delivering $10.2 million of GAAP Net Income and an attractive 34% EBITDA margin in the fourth quarter of 2020, as well as full year GAAP net income of $25.7 million, or $0.26 per share, and a 26% EBITDA margin.
    • The Company initiated share repurchases late in the fourth quarter under the previously announced share buyback program, completing purchases of 48,000 shares in the fourth quarter, and approximately 660,000 additional share purchases in the first quarter through March 8th, for approximately $2.9 million in total.
    • Terry Coelho promoted to Executive Vice President and Chief Financial Officer.

    "The impressive momentum and growth of our innovative products has persisted through the fourth quarter and full year 2020. Our high performing commercial team has been responding effectively to the evolving market conditions during the pandemic, and focused execution during the fourth quarter drove strong prescription trends for both BELBUCA and Symproic," stated Jeff Bailey, CEO of BDSI. "Our brands continued to capture market share in 2020 and the Company is poised for continued success as the selling environment improves in 2021."

    Fourth Quarter 2020 Financial Results

    Total Company Net Revenue for the fourth quarter of 2020 was a record $42.2 million, an increase of 33% compared to $31.6 million in the fourth quarter of 2019, and an increase of 7% compared to $39.4 million in the third quarter of 2020.

    BELBUCA Net Sales for the fourth quarter of 2020 were $35.6 million, an increase of 26% compared to $28.3 million in the fourth quarter of 2019, and an increase of 2% compared to $34.8 million in the third quarter of 2020. BELBUCA gross to net deductions increased in the fourth quarter as anticipated, primarily due to typical increases seen for Medicare coverage gap.

    Symproic Net Sales for the fourth quarter were $3.7 million, an increase of 35% compared to $2.7 million in the fourth quarter of 2019, and an increase of 6% compared to $3.5 million in the third quarter of 2020.

    BUNAVAIL Net Revenue for the fourth quarter was $2.4 million, reflecting the release of a portion of the sales returns reserves taken at the time discontinuation was announced. In June 2020, the Company discontinued marketing of BUNAVAIL.

    Total Operating Expenses for the fourth quarter of 2020 were $21.4 million, compared to $23.8 million in the fourth quarter of 2019 and $22.5 million in the third quarter of 2020.

    GAAP Net Income for the fourth quarter of 2020 was $10.2 million, or $0.10 per share, compared to GAAP net loss of $0.7 million, or $0.01 per share, in the fourth quarter of 2019 and GAAP net income of $9.4 million, or $0.09 per share, in the third quarter of 2020.

    EBITDA for the fourth quarter of 2020 was $14.3 million, or 34% of net sales, compared to $4.1 million or 13% of net sales, in the fourth quarter of 2019.

    Non-GAAP Net Income for the fourth quarter of 2020 was $13.7 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets. This reflects an increase of $7.3 million as compared to non-GAAP net income of $6.4 million in the fourth quarter of 2019, excluding the same items plus the non-recurring financial impact of discontinuation of the marketing of BUNAVAIL.

    Full-Year 2020 Financial Results

    Total Net Revenue for full-year 2020 was $156.5 million, an increase of 40% compared to $111.4 million for full-year 2019.

    BELBUCA Net Sales for full-year 2020 were $136.1 million, an increase of 40% compared to $97.5 million for full-year 2019.

    Symproic Net Sales for full-year 2020 were $14.7 million, an increase of 83% compared to 2019. The Company acquired Symproic in April 2019 and generated net sales of $8.1 million during the period from April to December 2019.

    BUNAVAIL Net Revenue for full-year 2020 was $3.7 million, compared to $2.3 million for full-year 2019, and includes the release of certain sales returns reserves of $2.4 million following the discontinuation of marketing in June 2020.

    Product Royalty Revenue for full-year 2020 was $1.9 million, compared to $3.5 million for full-year 2019.

    Total Operating Expenses for full-year 2020 were $98.8 million, compared to $86.1 million for full-year 2019.

    GAAP Net Income for full-year 2020 was $25.7 million, or $0.26 per share, an increase of $41.0 million compared to GAAP net loss of $15.3 million, or $(0.18) per share, for full-year 2019.

    EBITDA for full-year 2020 was $40.5 million, or 26% of net sales, an increase of $28.0 million compared to $12.5 million, or 11% of net sales for full-year 2019.

    Non-GAAP Net Income for full-year 2020 was $44.2 million and reflects GAAP net income excluding stock-based compensation, non-cash amortization of intangible assets, one-time expenses related to the CEO transition were incurred in 2020, and the non-recurring financial impact related to the discontinuation of the marketing of BUNAVAIL.

    Cash Position: As of December 31, 2020, cash and cash equivalents were approximately $111.6 million, compared to $63.9 million as of December 31, 2019. The total cash flow generation over 2020 of $47.7 million includes operating cash generation of $25 million, $3.4 million in proceeds from the exercise of options, and net proceeds of $19.6 million from the draw down in May 2020 of $20 million from our existing debt facility, partially offset by $0.2 million used to repurchase shares in the quarter.

    Financial Guidance

    The Company expects full year 2021 total net sales of $170 - $180 million, including full year 2021 BELBUCA net sales of $155 - $165 million. These estimates incorporate the expected impact in Q1 2021 from the winter storms in the South-Central region, which affected some of the Company's most productive territories. Total operating expenses are expected to be in the range of $115 - $120 million, as the Company continues to invest to support the growth of its brands, and EBITDA is expected to be in the range of $40 - $50 million in 2021. The Company expects to continue being operating cash flow positive throughout 2021.

    "I'm proud of how the BDSI team really pulled together, and also thrived, during 2020 in what was a challenging year for the industry due to the pandemic. I would like to recognize the efforts and contributions of all BDSI employees. I have great confidence that, with the strength of this team, high-growth brands, and a strong balance sheet, BDSI will continue to drive long-term shareholder value," stated Jeff Bailey.

    Conference Call & Webcast Details

    BioDelivery Sciences will host a conference call and webcast today, March 10, 2021, at 8:30 a.m. ET to present fourth quarter and full-year 2020 results and to provide a business update.  Dial-in details are as follows:

    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.

    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 expectations for total company net sales, BELBUCA net sales, operating expenses, EBITDA and operating cash flows in 2021) 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, non-cash 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 financial impact of the debt refinancing in 2019, the discontinuation of marketing of BUNAVAIL, and costs associated with the CEO transition in 2020.

    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.

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

    Contact:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Bob@LifeSciAdvisors.com



    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

    UNAUDITED CONSOLIDATED BALANCE SHEETS

    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

     December 31,

    2020
     December 31,

    2019
    ASSETS   
    Current assets:   
    Cash and cash equivalents$111,584  $63,888 
    Accounts receivable, net48,150  38,790 
    Inventory, net17,443  11,312 
    Prepaid expenses and other current assets5,208  3,769 
    Total current assets182,385  117,759 
    Property and equipment, net1,418  2,075 
    Goodwill2,715  2,715 
    License and distribution rights, net53,376  60,309 
    Other intangible assets, net  47 
    Total assets$239,894  $182,905 
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable and accrued liabilities$52,995  $53,993 
    Total current liabilities52,995  53,993 
    Notes payable, net78,452  58,568 
    Other long-term liabilities213  580 
    Total liabilities131,660  113,141 
    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, 0 and 2,093,155 shares

    outstanding at December 31, 2020 and December 31, 2019, respectively; Series B

    Non-Voting Convertible Preferred Stock, $0.001 par value, 443 and 618 shares

    outstanding at December 31, 2020 and December 31, 2019 respectively.
      2 
    Common Stock, $.001 par value; 235,000,000 and 175,000,000 shares authorized at

    December 31, 2020 and December 31, 2019 respectively; 101,417,441 and

    96,189,074 shares issued; 101,354,447 and 96,173,583 shares outstanding at

    December 31, 2020 and December 31, 2019, respectively.
    104  96 
    Additional paid-in capital449,264  436,306 
    Treasury stock, at cost, 62,994 and 15,491 shares as of December 31, 2020 and

    December 31, 2019, respectively
    (252) (47)
    Accumulated deficit(340,882) (366,593)
    Total stockholders' equity108,234  69,764 
    Total liabilities and stockholders' equity$239,894  $182,905 



    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES


    UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

     Quarter Ended December 31, Year Ended December 31,
     2020 2019 2020 2019
    Revenues:       
    Product sales$41,628  $30,450  $154,574  $107,888 
    Product royalty revenues539  1,187  1,897  3,341 
    Contract revenues      160 
    Total Revenues:42,167  31,637  156,471  111,389 
    Cost of sales8,294  7,265  24,665  21,590 
            
    Expenses:       
    Selling, general and administrative21,418  23,759  98,827  86,063 
    Total Expenses:21,418  23,759  98,827  86,063 
    Income from operations12,455  613  32,979  3,736 
    Interest expense, net(2,028) (1,308) (7,013) (19,040)
    Other (expense)/income, net3  (1) (3) 4 
    Income/(loss) before income taxes10,430  (696) 25,963  (15,300)
    Income tax benefit(233)   (252) (5)
    Net income/(loss)10,197  (696) 25,711  (15,305)
    Net income/(loss) attributable to common

    stockholders
    $10,197  $(696) $25,711  $(15,305)
    Basic       
    Weighted average common stock shares

    outstanding
    101,178,994  92,118,497  99,830,520  83,213,704 
    Basic earnings/(loss) per share$0.10  $(0.01) $0.26  $(0.18)
    Diluted       
    Weighted average common stock shares

    outstanding
    105,648,727  92,118,497  105,062,522  83,213,704 
    Diluted earnings/(loss) per share$0.10  $(0.01) $0.24  $(0.18)



    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS


    (U.S. DOLLARS, IN THOUSANDS)

     Year Ended December 31,
     2020 2019 2018
    Operating activities:     
    Net income (loss)$25,711  $(15,305) $(33,867)
    Adjustments to reconcile net income (loss) to net cash flows used in operating activities     
    Depreciation538  1,846  740 
    Accretion of debt discount and loan costs320  11,508  4,138 
    Amortization of intangible assets6,981  6,981  5,157 
    Provision for (recovery from) inventory obsolescence1,870  197  (56)
    Impairment loss on equipment    78 
    Stock-based compensation expense9,595  5,416  5,941 
    Deferred income taxes    40 
    Changes in assets and liabilities, net of effect of acquisition:     
    Accounts receivable(9,360) (25,163) (4,640)
    Inventories(8,001) (6,102) 741 
    Prepaid expenses and other assets(1,439) (581) 422 
    Accounts payable and accrued expenses(1,234) 32,275  (2,807)
    Net cash flows used in operating activities24,981  11,072  (24,113)
    Investing activities:     
    Product acquisitions  (30,685) (1,951)
    Acquisitions of equipment(13) (79) (112)
    Net cash flows used in investing activities(13) (30,764) (2,063)
    Financing activities:     
    Proceeds from exercise of stock options3,369  2,321  670 
    Proceeds from issuance of common stock, less underwriters fee

    discount
      48,000   
    Proceeds from issuance of Series B preferred stock    50,000 
    Payment on note payable  (67,346)  
    Proceeds from notes payable20,000  59,987   
    Equity finance costs  (410) (1,417)
    Payment of deferred financing fees(436)   (450)
    Loss on refinancing of former debt  (2,794)  
    Payment on share repurchase(205)    
    Net cash flows from financing activities22,728  39,758  48,803 
    Net change in cash and cash equivalents47,696  20,066  22,627 
    Cash and cash equivalents at beginning of year63,888  43,822  21,195 
    Cash and cash equivalents at end of year$111,584  $63,888  $43,822 



    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES


    UNAUDITED RECONCILIATION OF NON-GAAP METRICS

    (U.S. DOLLARS, IN THOUSANDS)

      Year Ended December 31,
    Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) 202020192018
    GAAP net income/(loss) $25,711 $(15,305$(33,867)
         Add back/(subtract):    
    Income tax provision 252 5 14 
    Net interest expense 7,013 19,036 10,206 
    Depreciation and amortization 7,521 8,748 6,188 
    EBITDA $40,497 $12,484 $(17,459)
    Reconciliation of GAAP net income/(loss) to Non-GAAP net

    income/(loss)
        
    GAAP net income/(loss) 25,711 (15,305(33,867)
         Non-GAAP adjustments:    
    Stock-based compensation expense 6,107 5,416 5,941 
    Amortization of intangible assets 6,982 6,981 5,157 
    Amortization of warrant discount  448 1,076 
    Non-recurring financial impact of debt refinance  11,866  
    Non-recurring financial impact of BUNAVAIL discontinuation 295 3,750  
    Non-recurring financial impact of CEO transition 5,145   
    Non-GAAP net income/(loss) $44,240 $13,156 $(21,693)



      Quarter Ended,
    Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) December 31,

    2020
    September 30,

    2020
    December 31,

    2019
    GAAP net income/(loss) $10,197 $9,383 $(696)
    Add back:    
    Provision for income taxes 233 211 1 
    Net interest expense 2,022 2,012 1,308 
    Depreciation and amortization 1,806 1,754 3,491 
    EBITDA $14,258 $13,360 $4,104 
    Reconciliation of GAAP net income/(loss) to Non-GAAP net

    income/(loss)
        
    GAAP net income/(loss) 10,197  9,383 (696)
    Non-GAAP adjustments:    
    Stock-based compensation expense 1,750 1,473 1,438 
    Amortization of intangible assets 1,733 1,734 1,899 
    Non-recurring financial impact of BUNAVAIL discontinuation   3,750 
    Non-recurring financial impact of CEO transition  67  
    Non-GAAP net income $13,680 $12,657 $6,391 


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  11. 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

    Bob@LifeSciAdvisors.com



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  12. 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

    BDSI_IR@bdsi.com

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989

    bob@lifesciadvisors.com



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  13. 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

    BDSI_IR@bdsi.com

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989

    bob@lifesciadvisors.com



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  14. 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

    BDSI_IR@bdsi.com 

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989

    bob@lifesciadvisors.com 



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  15. 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

    Bob@LifeSciAdvisors.com

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  16. 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

    Bob@LifeSciAdvisors.com



    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

    (Unaudited)

     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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  17. 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

    Bob@LifeSciAdvisors.com

    Primary Logo

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  18. 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

    Bob@LifeSciAdvisors.com

    Primary Logo

    View Full Article Hide Full Article
  19. 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

    Bob@LifeSciAdvisors.com

    Primary Logo

    View Full Article Hide Full Article
  20. 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

    BDSI_IR@bdsi.com

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989

    bob@lifesciadvisors.com

    Primary Logo

    View Full Article Hide Full Article
  21. 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

    BDSI_IR@bdsi.com

    Bob Yedid

    LifeSci Advisors

    (646) 597-6989

    bob@lifesciadvisors.com

    Primary Logo

    View Full Article Hide Full Article
  22. 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

    Bob@LifeSciAdvisors.com



    BIODELIVERY SCIENCES INTERNATIONAL, INC.
    AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

    (Unaudited)

     June 30,

    2020
     December 31,

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





    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES


    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

    (Unaudited)

     Three months ended June 30, Six months ended June 30,
     2020 2019 2020 2019
    Revenues:       
    Product sales$36,445  $28,056  $74,161  $47,815 
    Product royalty 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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  23. 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

    Bob@LifeSciAdvisors.com

     

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  24. 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
    BDSI_IR@bdsi.com 

    Bob Yedid
    LifeSci Advisors
    (646) 597-6989
    bob@lifesciadvisors.com 

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  25. 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: BDSI_IR@bdsi.com

     

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  26. 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
    tpatel@bdsi.com

    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