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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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] -
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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
[email protected] -
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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
[email protected]BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
(Unaudited)September 30,
2020December 31,
2019ASSETS Current assets: Cash and cash equivalents $ 100,177 $ 63,888 Accounts receivable, net 43,830 38,790 Inventory, net 18,887 11,312 Prepaid expenses and other current assets 5,754 3,769 Total current assets 168,648 117,759 Property and equipment, net 1,485 2,075 Goodwill 2,715 2,715 License and distribution rights, net 55,109 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 liabilities 53,409 53,993 Notes payable, net 78,363 58,568 Other long-term liabilities 300 580 Total liabilities 132,072 113,141 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 capital 446,910 436,306 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' equity 95,885 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 revenues 658 683 1,358 2,154 Contract revenues — — — 160 Total Revenues: 39,443 30,306 114,304 79,752 Cost of sales 5,376 5,350 16,371 14,325 Expenses: Selling, general and administrative 22,461 23,360 77,408 62,304 Total Expenses: 22,461 23,360 77,408 62,304 Income from operations 11,606 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 outstanding 101,031,317 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 outstanding 105,783,568 105,138,894 104,836,493 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 amortization 467 253 Accretion of debt discount and loan costs 231 11,441 Amortization of intangible assets 5,248 5,084 Provision for inventory obsolescence (297 ) 57 Stock-based compensation expense 7,845 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 activities 13,965 (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 payable 20,000 60,000 Proceeds from exercise of stock options 2,761 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 activities 22,324 38,643 Net change in cash and cash equivalents 36,289 12,041 Cash and cash equivalents at beginning of period 63,888 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) 2020 2019 2020 2019 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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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
[email protected]