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Biodelivery Sciences International (BDSI)

BioDelivery Sciences International, Inc. 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.

Company profile

Ticker
BDSI
Exchange
Website
CEO
Jeffrey Bailey
Employees
Incorporated
Location
Fiscal year end
Former names
MAS ACQUISITION XXIII CORP
SEC CIK
Subsidiaries
Arius Pharmaceuticals, Inc. • Arius Two, Inc. ...
IRS number
352089858

BDSI stock data

Calendar

9 Mar 22
15 Aug 22
31 Dec 22
Quarter (USD) Dec 21 Sep 21 Jun 21 Mar 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
22 Mar 22 Bailey Jeffrey Allen Common Stock Other Dispose J No No 0 105,133 0 0
22 Mar 22 Bailey Jeffrey Allen Stock Options Common Stock Sale back to company Dispose D No No 3.66 1,143,467 4.19M 0
22 Mar 22 Bailey Jeffrey Allen Stock Options Common Stock Sale back to company Dispose D No No 3.6 840,000 3.02M 0
22 Mar 22 Bailey Jeffrey Allen Stock Options Common Stock Sale back to company Dispose D No No 4.36 66,805 291.27K 0
22 Mar 22 Bailey Jeffrey Allen Stock Options Common Stock Sale back to company Dispose D No No 4.23 160,000 676.8K 0
22 Mar 22 Bailey Jeffrey Allen Stock Options Common Stock Sale back to company Dispose D No No 5.18 96,000 497.28K 0
22 Mar 22 Bailey Jeffrey Allen RSU Common Stock Sale back to company Dispose D No No 0 316,919 0 0
22 Mar 22 Greenleaf Peter Common Stock Other Dispose J No No 0 105,034 0 0
22 Mar 22 Greenleaf Peter Stock Options Common Stock Sale back to company Dispose D No No 3.66 114,347 418.51K 0
22 Mar 22 Greenleaf Peter Stock Options Common Stock Sale back to company Dispose D No No 2.93 64,164 188K 0
57.0% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 162 155 +4.5%
Opened positions 30 19 +57.9%
Closed positions 23 10 +130.0%
Increased positions 45 53 -15.1%
Reduced positions 53 45 +17.8%
13F shares Current Prev Q Change
Total value 251M 261.51M -4.0%
Total shares 58.85M 70.72M -16.8%
Total puts 337.8K 437.8K -22.8%
Total calls 1.2M 543.6K +120.0%
Total put/call ratio 0.3 0.8 -64.9%
Largest owners Shares Value Change
BLK Blackrock 7.31M $22.65M -3.7%
Vanguard 4.74M $14.7M +0.8%
Systematic Financial Management 4.34M $13.45M +7.8%
LSV Asset Management 3.51M $10.9M +82.7%
Royce & Associates 2.41M $7.46M +51.3%
Wasatch Advisors 2.25M $6.99M -58.4%
Magnetar Financial 2.18M $6.75M +330.7%
STT State Street 2.02M $6.27M -5.9%
Rubric Capital Management 1.75M $5.42M NEW
Geode Capital Management 1.72M $5.35M -1.4%
Largest transactions Shares Bought/sold Change
Flynn James E 29.2K -9.5M -99.7%
Deerfield Management 29.2K -9.14M -99.7%
Wasatch Advisors 2.25M -3.16M -58.4%
Rubric Capital Management 1.75M +1.75M NEW
Magnetar Financial 2.18M +1.67M +330.7%
LSV Asset Management 3.51M +1.59M +82.7%
Invenomic Capital Management 1.19M +1.19M NEW
Marshall Wace 1.11M +1.11M NEW
Fuller & Thaler Asset Management 866.65K +866.65K NEW
Royce & Associates 2.41M +815.42K +51.3%

Financial report summary

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Risks
  • We have incurred, and will continue to incur, direct and indirect costs as a result of the pending transaction with Collegium.
  • We have incurred significant losses since inception and as such, you cannot rely upon our historical operating performance to make an investment decision regarding our company.
  • If our competitors are successful in obtaining approval for Abbreviated New Drug Applications for products that have the same active ingredients as BELBUCA, Symproic or ELYXYB, sales of BELBUCA, Symproic or ELYXYB may be adversely affected.
  • Our long-term capital requirements are subject to numerous risks.
  • Our term loan agreement with Pharmakon contains restrictions that limit our flexibility in operating our business. We may be required to make a prepayment or repay the outstanding indebtedness earlier than we expect under our loan agreement if a prepayment event or an event of default occurs, including a material adverse change with respect to us, which could have a materially adverse effect on our business.
  • Social issues around the abuse of opioids, including law enforcement and other legal concerns over diversion of opioids and regulatory efforts to combat abuse, misuse and addiction, could impact the potential market for BELBUCA.
  • Government agencies may establish and promulgate usage guidelines that could limit the use of our products and drug candidates.
  • If we are unable to convince physicians as to the benefits of our products, we may incur delays or additional expense in our attempt to establish market acceptance.
  • We have been and expect to be significantly dependent on our collaboration agreements for the manufacturing of our products, which expose us to the risk of reliance on the performance of third parties.
  • We depend upon key personnel who may terminate their employment with us at any time.
  • We may be unable to manage our growth effectively.
  • We are exposed to product liability and, non-clinical liability risks which could place a substantial financial burden upon us, should lawsuits be filed against us.
  • We are presently a party to lawsuits by third parties who claim that our products, methods of manufacture or methods of use infringe on their intellectual property rights, and we may be exposed to these types of claims in the future.
  • If we are unable to adequately protect or enforce our rights to intellectual property or secure rights to third-party patents, we may lose valuable rights, experience reduced market share, assuming there is any market share, or incur costly litigation to, enforce, maintain or protect such rights.
  • We are dependent on third party suppliers for key components of our delivery technologies and products.
  • There are risks associated with our reliance on third parties for managed care, distribution infrastructure and channels.
  • The class-wide Risk Evaluation and Mitigation Strategy, or REMS, for all transmucosal fentanyl products, and similar programs for other narcotic products, may slow sales and marketing efforts for products that contain narcotics, which could impact our royalty and sales revenue from such products.
  • Our business and operations could suffer in the event of system failures.
  • Actions of activist shareholders could be disruptive and potentially costly and the possibility that activist shareholders may seek changes that conflict with our strategic direction could cause uncertainty about the strategic direction of our business.
  • COVID-19 may materially and adversely affect our business and our financial results.
  • Our failure to obtain government approvals or to comply with ongoing governmental regulations relating to our technologies could delay or limit introduction of any proposed formulations and products and result in failure to achieve revenues or maintain our ongoing business.
  • If users of our products are unable to obtain adequate reimbursement from third-party payers, or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not achieve material revenues.
  • Our business involves environmental risks related to handling regulated substances which could severely affect our ability to develop our drug delivery technology.
  • Government and other efforts to reform the healthcare industry could have adverse effects on our company, including the inability of users of our current and future approved products to obtain adequate reimbursement from third-party payers, which could lead to diminished market acceptance of, and revenues from, such products.
  • We may also be subject to healthcare laws, regulation and enforcement. Our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.
  • Our stock price is subject to market factors and market volatility, both generally and with respect to our industry and our company specifically. As such, there is a risk that your investment in our common stock could fluctuate in value.
  • Additional authorized shares of our common stock and preferred stock available for issuance may adversely affect the market for our common stock.
  • Anti-takeover provisions under our organizational documents and Delaware law could delay or prevent a change of control, which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • The financial and operational projections that we may make from time to time are subject to inherent risks.
  • We do not intend to pay dividends on our common stock.
Management Discussion
  • Item 7.    Management’s Discussion and Analysis of Financial Condition and Results of Operations.
  • Our growth strategy continues to evolve from our capable and successful commercial organization. We seek to further build a well-balanced, diversified, high-growth specialty pharmaceuticals company focused on delivering innovative therapies for patients living with serious and debilitating diseases. Through our industry-leading commercialization infrastructure, we continue to deliver strong growth of our existing portfolio and also possess the skills to launch new product initiatives. As part of our corporate growth strategy, we have licensed and acquired products and will pursue additional product opportunities in therapeutic areas that meet the needs of our patients. With focused attention on patient access and a structured business-development process for transformative acquisitions or licensing opportunities, we will fully leverage our experience and apply it toward developing new partnerships that enable us to commercialize novel products that can improve the lives of people suffering from challenging medical conditions.
  • We will continue to drive value from our product portfolio with a strong emphasis on BELBUCA growth, including further adoption in the large long-acting opioid market. The product uses our proprietary BEMA technology and maintains a unique delivery profile, strong payer access position and growing physician interest. Symproic continues to climb in both prescriptions and prescribers, proving to be a valuable complementary product for our called upon universe of BELBUCA targets. Our latest portfolio addition, ELYXYB, will furthermore benefit from our sales and marketing expertise and will provide a building foundation in the neurology specialty to fuel future growth opportunities for the business.

Content analysis

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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. freshman Avg
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Patents

Utility
Multidirectional Mucosal Delivery Devices and Methods of Use
21 Jul 22
The present invention relates to a pharmaceutical dosage form for transmucosal delivery of an active agent to two or more mucosal surfaces.
Utility
Transmucosal Drug Delivery Devices for Use In Chronic Pain Relief
30 Jun 22
Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device.
Utility
Methods of Treating Pain
30 Jun 22
The present application relates to a method of providing a therapeutic regimen for the treatment of pain, wherein said method comprises administering an oral liquid pharmaceutical composition comprising celecoxib or a pharmaceutically acceptable salt thereof to a subject in need thereof.
Utility
Patch Devices, Methods and Apparatus for Forming, and Testing Pharmaceutical Agent Delivery Patch Devices
16 Jun 22
A method for manufacturing a plurality of pharmaceutical agent delivery patch devices includes: providing a supply web including an active layer containing a pharmaceutically active agent; and cutting the supply web to form cut lines through the active layer.
Utility
Sustained Release Buprenorphine Microspheres (SRBM) and Methods of Use Thereof
10 Mar 22
The present invention is directed to a sustained release buprenorphine microsphere (SRBM) formulation capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 7 days to about 6 months.