BDSI BioDelivery Sciences International Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
BEMA Buprenorphine
Pain
|
Approved
Approved
|
Approved October 26, 2015.
|
|
Clonidine gel
Painful diabetic neuropathy (PDN)
|
Phase 2b
Phase 2b
|
Phase 2b data released December 13, 2016 - primary endpoints not met.
|
|
BEMA Buprenorphine/Naloxone (BNX) - BUNAVAIL
Opioid dependence
|
Approved
Approved
|
Approved June 6, 2014.
|
Latest News
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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
[email protected]
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
UNAUDITED CONSOLIDATED BALANCE SHEETS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)December 31,
2020December 31,
2019ASSETS Current assets: Cash and cash equivalents $ 111,584 $ 63,888 Accounts receivable, net 48,150 38,790 Inventory, net 17,443 11,312 Prepaid expenses and other current assets 5,208 3,769 Total current assets 182,385 117,759 Property and equipment, net 1,418 2,075 Goodwill 2,715 2,715 License and distribution rights, net 53,376 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 liabilities 52,995 53,993 Notes payable, net 78,452 58,568 Other long-term liabilities 213 580 Total liabilities 131,660 113,141 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 capital 449,264 436,306 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' equity 108,234 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 revenues 539 1,187 1,897 3,341 Contract revenues — — — 160 Total Revenues: 42,167 31,637 156,471 111,389 Cost of sales 8,294 7,265 24,665 21,590 Expenses: Selling, general and administrative 21,418 23,759 98,827 86,063 Total Expenses: 21,418 23,759 98,827 86,063 Income from operations 12,455 613 32,979 3,736 Interest expense, net (2,028 ) (1,308 ) (7,013 ) (19,040 ) Other (expense)/income, net 3 (1 ) (3 ) 4 Income/(loss) before income taxes 10,430 (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
outstanding101,178,994 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
outstanding105,648,727 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 Depreciation 538 1,846 740 Accretion of debt discount and loan costs 320 11,508 4,138 Amortization of intangible assets 6,981 6,981 5,157 Provision for (recovery from) inventory obsolescence 1,870 197 (56 ) Impairment loss on equipment — — 78 Stock-based compensation expense 9,595 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 activities 24,981 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 options 3,369 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 payable 20,000 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 activities 22,728 39,758 48,803 Net change in cash and cash equivalents 47,696 20,066 22,627 Cash and cash equivalents at beginning of year 63,888 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) 2020 2019 2018 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,
2020September 30,
2020December 31,
2019GAAP 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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BioDelivery Sciences to Report Fourth Quarter and Full Year 2020 Financial Results on March 10, 2021View Full Article Hide Full Article
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
[email protected] -
View Full Article Hide Full Article
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
[email protected]Bob Yedid
LifeSci Advisors
(646) 597-6989
[email protected] -
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Oral Presentation of Data from Phase I Safety Study & Secondary Respiratory Outcomes
Comparing BELBUCA® to Oxycodone on January 16 from 1:10pm – 2:10pm CTRALEIGH, 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.
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
[email protected]Bob Yedid
LifeSci Advisors
(646) 597-6989
[email protected] -
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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
[email protected]Bob Yedid
LifeSci Advisors
(646) 597-6989
[email protected]