According to a definitive agreement between Indivior PLC and Opiant Pharmaceuticals, Inc., which the two companies announced today, Indivior will buy Opiant for an upfront payment of $20.00 per share in cash (roughly $145 million total), plus up to $8.00 per share in contingent value rights (“CVRs”) that could become due if certain net revenue milestones are met by OPNT003 over the course of the relevant seven-year period following its app launch. The boards of directors of both companies have unanimously authorised the transaction.
“Our work in combatting addiction has never been more critical, with overdose deaths in the United States occurring at near record numbers1”, “Opiant’s portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior’s strong commercial capabilities are expected to propel a combined product pipeline with the potential to help patients along a continuum from substance use disorder and rescue to recovery. The combination with Opiant will provide Indivior with one of the most comprehensive and relevant treatment platforms to address the ongoing U.S. opioid and overdose epidemic and extends our leadership position in addiction treatments. We look forward to working with Opiant’s talented team as we undertake our shared mission of changing patients’ lives through access to life-transforming treatment for substance use disorders.”
Mark Crossley, Chief Executive Officer, Indivior
“We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines”, “This transaction combines Opiant with an organization that shares our patient-focused mindset, and we believe creates immediate value for patients, our employees and our stockholders. It will enable us to leverage Indivior’s global scale, commercial strength and scientific expertise to accelerate our mission to create best-in-class medicines for the treatment of substance use disorders and drug overdose.”
Roger Crystal, M.D., President and Chief Executive Officer, Opiant
A biopharmaceutical startup called Opiant is working to cure drug overdoses and addiction by using injectable and intranasal delivery methods. A therapy for opioid overdose, NARCAN® Nasal Spray, was developed in part with help from opioid. Along with OPNT003, nasal nalmefene, the pipeline also consists of OPNT002, nasal naltrexone, which is presently undergoing a Phase II trial to determine its potential as a treatment for alcohol consumption and cravings, and OPNT004, a CB-1 antagonist that is undergoing preclinical development as a potential injectable remedy for acute cannabinoid overdose.
Opiant has been working on OPNT003, an investigational opioid overdose reversal agent, as the opioid crisis has gotten worse due to the rising use of synthetic opioids like illegal fentanyl. The increase in overdose deaths in the United States is due to these potent narcotics (103,000+ overdose deaths were reported in the most recent annual period, of which more than 75% were caused by opioids, primarily fentanyl and synthetic opioids1). OPNT003 is intended for use by non-healthcare professionals and is administered intravenously. Observations from numerous clinical studies support its conceivable quick onset and protracted action.
In November 2021, Opiant was granted FDA Fast Track Designation for OPNT003 and is anticipated to finish submitting OPNT003’s New Drug Application (“NDA”) to the FDA in the fourth quarter of 2022. Subject to FDA approval, a fast-track application is anticipated to be approved in the third quarter of 2023, with a launch in the United States anticipated in the following months.
According to the merger agreement, Indivior will buy all of Opiant’s outstanding shares for a one-time payment of $20.00 per share in cash plus up to $8.00 per share in contingent value rights (“CVRs”) that could become due in the event that Opiant’s lead asset (OPNT003) achieves certain net revenue milestones over the course of the applicable seven-year period. Indivior anticipates using its available cash to pay the approximately $145 million total upfront consideration.
According to the CVRs, Indivior would pay $2.00 per CVR if OPNT003 met the net revenue milestones of (i) $225 million, (ii) $300 million, and (iii) $325 million during any stretch of four successive quarters prior to the seventh anniversary of the U.S. commercial launch. If OPNT003 generates net sales of $250 million over the course of four consecutive quarters prior to the third anniversary of the U.S. commercial launch, the remaining (iv) $2.00 per CVR will be paid. If OPNT003 meets all four CVRs, Indivior would only be responsible for paying a maximum of an additional $68 million.
The deal is subject to the usual closing requirements, which include receiving shareholder approval and receiving US antitrust clearance as well as clearance from the Committee on Foreign Investment in the United States (CFIUS). The Opiant Board of Directors members have entered into a voting agreement with Indivior and agreed to vote their shares in favour of the transaction. They currently own about 4.5% of the outstanding Opiant shares. The parties hope to finish the transaction in the first quarter of 2023, subject to approvals.
Strong Strategic and Financial Justification
The merger unites two successful businesses with the leadership, infrastructure, pipeline, and track record needed to launch novel, potentially game-changing addiction medicines. It also offers the chance to boost net income and boost shareholder value. Indivior will gain from an improved portfolio in the following ways:
Strengthened and Extended Leadership in Addiction Treatment and Science: In order to provide both evidence-based therapy and overdose rescue options, OPNT003 is a very complimentary drug to SUBLOCADE (buprenorphine extended-release) Injection for subcutaneous release (CIII). The adoption of OPNT003 expands Indivior’s array of addiction treatments and gives it access to one of the most comprehensive and current treatment platforms to address the ongoing US opioid and overdose pandemic. Additionally, Opiant has a pipeline of earlier-stage assets to potentially treat other substance use disorders, such as Alcohol Use Disorder, Acute Cannabinoid Overdose, and Opioid Use Disorder. Opiant brings new formulation and nasal drug development capabilities as well.
A Potentially Highly Relevant Treatment for Opioid Overdose Rescue: OPNT003 diversifies Indivior’s portfolio with a new and appealing growth avenue. Given that over 75% of recorded overdose deaths in the United States occurred from synthetic opioids like fentanyl in the year ending April 20221, OPNT003 is particularly well-suited as a potential treatment for opioid overdose. Before generic versions of NARCAN® Nasal Spray became available in December of that same year, the current gold standard of treatment for opioid overdose rescue saw a peak net revenue of more than $400 million. According to Indivior, OPNT003’s distinct clinical profile suggests that it has the potential to generate annual net revenues of $150 million to $250 million.
Strong Commercial and Scientific Capabilities: By combining the commercial and scientific capabilities and knowledge of both firms, it will be possible to speed up the adoption of OPNT003 once it becomes commercially available. To further optimise the launch, Indivior plans to make use of its commercial presence in Organized Health Systems (OHS) and its payor access capabilities. Deep advocacy alliances and an R&D company that has spent more than 20 years developing paradigm-shifting OUD treatment solutions will assist these efforts. The other clinical and pre-clinical pipeline assets of Opiant are anticipated to gain even more from Indivior’s extensive connections and leadership in the field of addiction science. The commercial leadership of Opiant, which has recent experience in the overdose rescue market and extensive knowledge in nasal delivery technology, will be advantageous for Indivior.
Attractive Financial Profile: After the second full year of launch, Indivior’s earnings are anticipated to increase as a result of the successful commercialization of OPNT003.
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