Indivior Pharmaceuticals (INDV) Stock News

Indivior PLC (Nasdaq/LSE: INDV) has provided an update on Aelis Farma's clinical Phase 2B trial results for AEF0117, a potential treatment for Cannabis Use Disorder (CUD). The study, which evaluated the efficacy and safety in treatment-seeking participants with moderate to severe CUD, failed to meet its primary and secondary endpoints. The primary goal was to reduce cannabis use to ≤1 day per week, while secondary endpoints included complete abstinence or use ≤2 days per week.

Despite the disappointing results, the study highlights the need for further research into CUD subpopulations, particularly those with severe cases. As a result of these outcomes, Indivior does not currently plan to exercise its option to license the global rights to AEF0117, which was part of a strategic collaboration with Aelis Farma.

Indivior PLC (LSE/Nasdaq: INDV) announced the first order of OPVEE® (nalmefene) nasal spray from the Biomedical Advanced Research and Development Authority (BARDA). This order, worth $8.7 million, is part of BARDA's national preparedness efforts against synthetic opioid overdose emergencies. OPVEE is the first and only nasal rescue medicine specifically indicated for synthetic opioids like fentanyl.

The order comes as opioid overdose deaths in the U.S. reached 76,922 in the year ending January 2024. BARDA will use OPVEE to supplement local supplies for emergency rooms, ambulances, and other sites in case of medical countermeasure shortages during emergencies. This is the first option exercised under an agreement announced in December 2023, with BARDA having the option to purchase additional OPVEE annually for the next nine years.

Indivior PLC (Nasdaq/LSE: INDV) has announced a new $100 million share repurchase program to be executed over an accelerated six-month timeframe. This follows the expedited completion of their current $100 million program, expected to finish by the end of July 2024. The new program, set to begin immediately after, will be carried out through a non-discretionary agreement with Morgan Stanley.

Key points:

• Repurchases will be made on London Stock Exchange, Aquis Stock Exchange, and CBOE Europe
• Maximum of 13,649,017 ordinary shares may be repurchased
• All repurchased shares will be cancelled to reduce issued share capital
• Program complies with shareholder authorization and regulatory standards

Indivior PLC (Nasdaq/LSE: INDV) has announced its financial results for the quarter ending June 30, 2024. The company has made available its earnings release, investor presentation, and webcast on its official website at www.indivior.com. A live webcast presentation is scheduled for 13:00 BST (8:00 am ET), to be hosted by CEO Mark Crossley. Interested parties can access the presentation through a webcast link or by registering for telephonic participation. The event provides an opportunity for investors and analysts to gain insights into Indivior's Q2 2024 financial performance and potentially discuss future outlook and strategies.

Indivior PLC (Nasdaq/LSE: INDV) has updated its Q2 and FY 2024 financial outlook, reflecting adverse market conditions impacting SUBLOCADE and initial OPVEE adoption. The company expects SUBLOCADE's net revenue (NR) to grow 25% year-over-year (YOY) and adjusted operating income to rise by 12% YOY in FY 2024. Indivior is discontinuing PERSERIS sales and marketing due to financial non-viability, affecting around 130 employees. The company settled a $85 million litigation with Health Care Services Corp, and expects Q2 net revenue to be between $295m-$303m, with SUBLOCADE contributing $188m-$196m. Indivior will host a conference call at 8:00 AM U.S. EDT.

Indivior has published new data comparing the effectiveness of intranasal (IN) nalmefene (OPVEE 2.7mg) and IN naloxone (4 mg) in reversing synthetic opioid overdoses. The study, using a validated translational model, shows that a single dose of OPVEE significantly reduces simulated cardiac arrests caused by fentanyl and carfentanil overdoses compared to naloxone. For instance, a single OPVEE dose reduced the cardiac arrest rate to 12% in chronic opioid users, whereas naloxone reduced it to 47%. Multiple naloxone doses were required to match OPVEE's effectiveness. The simulation involved 2000 virtual patients, highlighting OPVEE's superior performance in reversing overdoses, which is critical given the high rates of synthetic opioid-linked fatalities in the US. These findings could inform better emergency response strategies.

Indivior has initiated dosing of the first subject in a Phase 2 study of INDV-2000, a non-opioid treatment for Opioid Use Disorder (OUD). This double-blind, placebo-controlled trial will assess the safety and efficacy of INDV-2000 over three months in participants with moderate to severe OUD. Supported by an NIH-HEAL grant, the study aims to determine the dose-response relationship for INDV-2000, an orexin-1 receptor antagonist demonstrated to reduce opioid self-administration in animal studies. INDV-2000 offers a potential new treatment option for individuals seeking non-opioid alternatives.

Indivior, a leading addiction treatment company, will host an analyst teach-in event in New York City, confirming its FY 2024 guidance. The company expects net revenue between $1,240m and $1,330m, an 18% increase from FY 2023. SUBLOCADE revenue is projected at $820m to $880m, a 35% rise. OPVEE revenue is anticipated to be $15m to $25m, and PERSERIS revenue is forecasted at $55m to $65m, a 43% increase. SUBOXONE Film market share is expected to decline by 1-2 percentage points. Adjusted gross margin is estimated to be in the low to mid-80s range.

Adjusted SG&A expenses are projected at $575m to $590m, with R&D expenses between $120m and $130m. Adjusted operating profit is expected to be $330m to $380m. The event will be webcast and aims to provide an in-depth overview of Indivior's growth and value creation strategies.

Summary not available.