Welcome to our dedicated page for Biodelivery Sciences Intl news (Ticker: BDSI), a resource for investors and traders seeking the latest updates and insights on Biodelivery Sciences Intl stock.
This page contains historical news coverage for BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company that operated independently until its acquisition by Collegium Pharmaceutical in March 2022. The archived news provides context on the company's business operations, product developments, and corporate events before it became a wholly-owned subsidiary.
During its time as a publicly-traded company, BioDelivery Sciences generated news related to pain management product launches, clinical trial results, FDA regulatory decisions, and corporate partnerships. The company's focus on proprietary drug delivery technologies, particularly its BioErodible MucoAdhesive (BEMA) platform, positioned it within the specialty pharmaceutical sector addressing chronic pain and opioid-related complications.
News coverage of BDSI included developments related to its commercial products such as BELBUCA for chronic pain management, Symproic for opioid-induced constipation, and ONSOLIS for breakthrough cancer pain. Additionally, coverage often addressed pharmaceutical industry trends affecting pain management therapies, regulatory developments surrounding controlled substance prescribing, and the broader opioid crisis context within which the company's products operated.
The acquisition by Collegium Pharmaceutical in early 2022 represented a significant corporate event, with news coverage detailing the merger agreement, tender offer process, and strategic rationale. Following the acquisition's completion in March 2022, news specific to the former BioDelivery Sciences operations became integrated within Collegium Pharmaceutical's corporate announcements and financial reporting. This archive documents the company's history and the developments that shaped its trajectory as an independent pharmaceutical company focused on innovative pain management solutions.
BioDelivery Sciences International (BDSI) announced the commercial launch of ELYXYB, the first FDA-approved oral solution for the acute treatment of migraines in adults, available as of February 24, 2022. This product enhances BDSI's portfolio and marks its entry into the neurology market. ELYXYB offers fast-acting relief and is designed for convenience, without the need for mixing or measuring. It is supported by a co-pay savings program to ensure patient access. The product is protected by six patents expiring in 2036, establishing a growth platform for BDSI.
BioDelivery Sciences International, Inc. (BDSI) has announced a definitive merger agreement with Collegium Pharmaceutical, Inc. (COLL) to purchase all outstanding shares of BDSI at $5.60 per share, valuing the transaction at approximately $604 million. This represents a 54% premium to BDSI's closing price of $3.64 on February 11, 2022, and a 65% premium over the 30-day volume-weighted average price of $3.40. The deal has been unanimously approved by both companies' boards and is expected to close in late Q1 2022, pending a majority of shares tendered and other customary conditions.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) projected a strong financial performance for 2021, expecting total net revenues of $165-$167 million, with BELBUCA net sales anticipated to reach $147-$148 million. This surpasses previous guidance and indicates solid growth in the opioid market despite challenges posed by COVID-19. The company plans to launch ELYXYB, aimed at the $1.9 billion migraine market, with projected peak sales of $350-$400 million. The firm also successfully defended BELBUCA's patent, ensuring exclusivity until 2032.
BioDelivery Sciences International (NASDAQ: BDSI) has secured a favorable ruling from the U.S. District Court of Delaware in its patent litigation against Alvogen Group regarding its BELBUCA® product. The court upheld the validity of BDSI's patents, allowing continued market exclusivity until 2032. Alvogen conceded infringement, which solidifies BDSI's position in the chronic pain market. CEO Jeff Bailey expressed optimism for future business development and thanked shareholders for their continued support during the litigation.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) reported a net revenue of $41.1 million, marking a 4% increase year-over-year for Q3 2021. Key highlights include GAAP EPS of $0.07, an EBITDA margin of 27%, and operating cash flow of $7.0 million. The company closed the acquisition of ELYXYB, a new FDA-approved oral solution for acute migraine, with potential peak sales of $350 - $400 million. However, BDSI lowered its revenue guidance to $162 - $167 million for 2021 due to market challenges.
BioDelivery Sciences International (NASDAQ: BDSI) announced the appointment of John Golubieski as Chief Financial Officer, effective November 4, 2021. Golubieski brings over 30 years of financial experience, previously serving in senior roles at companies like Bristol-Myers Squibb and King Pharmaceuticals. His expertise is expected to enhance BDSI's growth strategy. The company also thanked outgoing CFO Terry Coelho for her contributions, as she transitions to another opportunity.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) will report its third quarter 2021 financial results on November 3, 2021, before U.S. markets open. A conference call and webcast will follow at 8:30 AM ET to discuss the results and provide a business update. BDSI focuses on chronic conditions and uses its proprietary BioErodible MucoAdhesive (BEMA®) technology to develop therapies for serious issues like chronic pain and opioid-induced constipation. The announcement marks an important date for stakeholders looking for insights into the company's financial health.
BioDelivery Sciences International (NASDAQ: BDSI) announced a virtual Investor Day on October 14, 2021, featuring insights on ELYXYB, the first FDA-approved ready-to-use oral solution for treating acute migraine in adults. The event will include a presentation by Dr. Richard B. Lipton, a leading expert in migraine treatment, discussing current treatments and unmet needs in this area. BDSI management will also provide an overview of the migraine market and ELYXYB's role. Following the presentations, there will be a Q&A session with Dr. Lipton and BDSI's management team.
BioDelivery Sciences International (NASDAQ: BDSI) announced the acquisition of U.S. and Canadian rights to ELYXYB™ (celecoxib oral solution) from Dr. Reddy's Laboratories. ELYXYB is the first FDA-approved ready-to-use oral solution for the acute treatment of migraines in adults, with plans for a commercial launch in Q1 2022. The acquisition aims to expand BDSI's portfolio in neurology, addressing the needs of approximately 40 million migraine sufferers in the U.S. ELYXYB has shown promising clinical trial results, including rapid onset of action and improved pain relief compared to placebo.
BioDelivery Sciences International (NASDAQ: BDSI) presented three scientific posters on BELBUCA® (buprenorphine buccal film) at PAINWeek 2021, highlighting its safety versus oxycodone. The posters focus on risk stratification, secondary respiratory outcomes, and pupillometry effects based on Phase 1 trials. Dr. Thomas Smith emphasized the importance of these findings for chronic pain management. BELBUCA® is approved for severe pain management in chronic conditions, but carries risks of addiction and respiratory depression.
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