London-based pharmaceutical company Indivior began trading on the Nasdaq Global Select Market today, after receiving a green light from the U.S. Securities & Exchange Commission, the company said Monday.
Indivior (LSE: INDV), known for its development of medications to treat substance use disorders and serious mental illnesses, hopes that this additional U.S. listing will raise its profile within its largest market. The company plans to maintain its premium listing on the London Stock Exchange and its position in the FTSE 250 index.
In a statement, CEO Mark Crossley called the listing “an important milestone.”
“We believe it will bring additional exposure to both Indivior and the disease space in the U.S., which is our largest opportunity market,” Crossley said. “Over time, we expect it will facilitate increased ownership by additional U.S.-based biopharma investors. We also are mindful of the significant unmet need for opioid use disorder treatment in the U.S., and are hopeful our U.S. listing will help raise awareness of the opioid epidemic.”
The company clarified that no new shares are being offered as part of this listing. Its ordinary shares will trade under the ticker symbol “INDV” on both the Nasdaq and the London Stock Exchange.
As part of the celebrations around the Nasdaq listing, Crossley, patients, and their families will ring the opening bell at the Nasdaq MarketSite in Times Square on Wednesday.
“Addiction is often misunderstood as a personal moral failing, but the reality is that it’s a disease that requires medical treatment,” Crossley said. “At Indivior, we want to change how substance use disorders, mental illness, and opioid overdose are viewed and treated.”
The company also launched a patient-focused advertising campaign coinciding with the bell-ringing event.
Indivior is primarily known for Sublocade, a monthly injection to help individuals combat opioid addiction. The company is aiming to reach an annual net revenue of $1 billion by the end of 2025. That target, according to the company, is driven by its work with health groups and its efforts to work within the U.S. Justice System. The company believes that the Sublocade could potentially bring in more than $1.5 billion annually in the long term.
Over the past two years, Indivior has heavily invested in Sublocade, as well as Perseris, a drug for schizophrenia. However, it anticipates these expenses will grow more slowly and constitute a smaller portion of its total revenue. The company does plan to increase its investment in research and development for new addiction treatments, which will partly offset the decrease in expenses.
Looking ahead, Indivior intends to develop a treatment for alcohol addiction and cannabis use disorder.
Past Legal Issues
- According to the company filing, in 2019, the U.S. Attorney’s Office for the Western District of Virginia brought an indictment, followed by a superseding indictment against the company in connection with its marketing and promotional practices related to SUBOXONE Film and SUBOXONE and SUBUTEX Tablets. The indictments charged Indivior Inc. and Indivior PLC with health care fraud, mail fraud, wire fraud, and conspiracy to commit the same. They generally alleged that the Company had falsely represented that SUBOXONE film was safer and less susceptible to misuse, abuse, diverse, and inadvertent pediatric exposure than SUBOXONE tablets, purportedly to delay approval of generic versions of SUBOXONE tablets and retain market share.
- On July 24, 2020, as part of a global resolution with the U.S. Attorney’s Office for the Western District of Virginia, the DOJ’s Consumer Protection Branch, the FTC, and several U.S. state attorneys general, a wholly-owned subsidiary of Indivior PLC pleaded guilty to a single count of making a false statement relating to healthcare matters in 2012. DOJ dismissed all charges in the indictment and the company agreed to pay substantial fines totaling $600 million and agreed to substantial reporting and compliance obligations related to its U.S. operations, among other things.
- In January 2021, the company announced it had reached an agreement with Reckitt Benckiser Group plc to resolve claims that RB issued in the Commercial Court in London in November 2020, seeking indemnity under the Demerger Agreement entered into on November 17, 2014 between RB and Indivior to effect the Demerger and to govern the relationship between the RB Group and the Indivior Group following the Demerger. Pursuant to the settlement, RB agreed to withdraw the $1.4 billion claim and to release Indivior from any claim for indemnity under the Demerger Agreement relating to the DOJ and FTC settlements which RB entered into in July 2019, as well as other claims for indemnity arising from those matters. Indivior agreed to pay RB a total of $50 million and also agreed to release RB from any claims to seek damages relating to Indivior’s settlement with the DOJ and the FTC.
- In January 2022, the United States District Court for the District of New Jersey approved the Group’s Stipulation and Agreement of Settlement of a securities law class action brought in that court by holders of our Level 1 American Depository Receipts (ADRs) for approximately $2 million. This class action was filed in 2019 against Indivior PLC and a number of directors and officers for alleged violations of federal securities laws, including among other things Section 10(b) of the Exchange Act and Rule 10b-5. Plaintiffs’ allegations in this class action lawsuit mirrored many of the allegations of the 2019 Indictment, including that the Group had falsely represented that SUBOXONE Film was safer and less susceptible to misuse, abuse, diverse, and inadvertent pediatric exposure than SUBOXONE and SUBUTEX Tablets, in order increase SUBOXONE Film revenues in the United States and delay generic competition. The Plaintiffs alleged that Indivior made these untrue statements of material facts or omitted material facts and employed devices, schemes and artifices to defraud and engaged in acts, practices and a course of business that operated as a fraud or deceit upon the class in order to inflate its stock price.
- In July 2022, the company settled antitrust, patent infringement, and wrongful injunction claims with the manufacturer of a generic buprenorphine/naloxone film drug product for approximately $72 million.
- Civil antitrust cases filed by a class of direct purchasers, a class of end payors, and 41 states and the District of Columbia have been consolidated in multi-district litigation pending in the U.S. District Court for the Eastern District of Pennsylvania, which is set for trial beginning September 18, 2023, against Indivior Inc. The parties are engaged in mediation which is overseen by the trial court. In 2022, the Group recognized a provision of $290 million related to certain multidistrict antitrust class and state claims for the purpose of settlement only. Because this litigation is in various stages, Indivior said it cannot predict with any certainty how these matters will ultimately be resolved, or the costs or timing of such resolution. In particular, any final aggregate costs of these matters, whether resolved by settlement or trial, may be materially different from the previously recorded provision. The aggregate amount of damages claimed by the plaintiffs in the Antitrust MDL exceeds Indivior Inc.’s resources to pay. The company said it cannot predict with any certainty whether it will reach settlement with the antitrust claimants. Separate antitrust cases filed by several insurance companies are pending in the Circuit Court for the County of Roanoke, Virginia. A trial on the Group’s pleas in bar (affirmative defense of statute of limitations) related to these cases in Roanoke, Virginia is scheduled for October 30, 2023 to November 3, 2023, and trial on the merits is scheduled for July 15, 2024 to August 8, 2024. The amount of damages claimed by these insurance company plaintiffs also exceeds Indivior Inc.’s resources to pay. Finally, Humana, Centene, and other insurance carriers filed antitrust cases in federal court in the Eastern District of Pennsylvania in 2020. The federal district court dismissed the case before it, and the Third Circuit Court of Appeals affirmed the dismissal. Humana separately had filed a Kentucky state court case which was stayed pending a decision in the federal court case, and remains stayed at this time. Centene also filed an action in the Circuit Court for the County of Roanoke, Virginia following the Third Circuit’s decision.
- The company has been named as a defendant in more than 450 civil lawsuits alleging that they engaged in a longstanding practice to market opioids as safe and effective for the treatment of long-term chronic pain to increase the market for opioids and their own market share, or alleging individual personal injury claims.
- In September 2022, certain shareholders issued representative and multiparty claims against the Group in the High Court of Justice for the Business and Property Courts of England and Wales, King’s Bench Division generally alleging that the Group violated the UK Financial Services and Markets Act 2000 by making false or misleading statements or material omissions in public disclosures, including the 2014 Demerger Prospectus, regarding an alleged product-hopping scheme regarding the switch from SUBOXONE Tablets to SUBOXONE Film. A hearing on the application to strike out has been scheduled for November 20-21, 2023.