Indivior PLC(INDV)2025-03-03 21:35Revenue and Market Share - The U.S. accounted for 85%, 83%, and 81% of net revenues for the years ended December 31, 2024, 2023, and 2022, respectively[51]. - The company has a significant share of oral buprenorphine medication-assisted treatment (BMAT) at 50%, 51%, and 49% in 2024, 2023, and 2022, respectively[67]. - Indivior's marketed products generated net sales of 374 million for SUBOXONE Film in 2024[111]. - The market share of SUBOXONE Film has declined to an average of 16% in 2024, facing competition from five generic competitors in the U.S.[128]. - Approximately 85% of the company's net revenues come from the U.S. market, which is not a single payor market but a complex system involving federal and state agencies[159]. - In 2024, 85% of the company's net revenues were derived from the U.S., down from 83% in 2023 and 81% in 2022[181]. - The company's three largest customers accounted for 55% of global net revenues in 2024, with the largest customer contributing 19%[184]. Product Development and Approvals - SUBLOCADE became the largest product by net revenue for the company by the second quarter of 2022[62]. - OPVEE (nalmefene) nasal spray was approved by the FDA in May 2023 and began marketing in October 2023[63]. - The FDA approved label changes for SUBLOCADE on February 24, 2025, allowing for a rapid initiation protocol and alternative injection sites[75]. - The company launched sales of SUBLOCADE in 2018, which is the first long-acting buprenorphine-based injectable for OUD[62]. - OPVEE (nalmefene) nasal spray was approved by the FDA on May 22, 2023, for emergency treatment of opioid overdose, with an onset of action of 2.5 to 5 minutes[124][125]. - SUBLOCADE is the first long-acting buprenorphine-based injectable approved by the FDA for moderate to severe opioid use disorder (OUD) treatment, showing increased abstinence from illicit opioids compared to placebo[112]. - The RECOVER extension study demonstrated improved patient-reported quality-of-life outcomes, including health status and employment, for patients receiving SUBLOCADE[112]. - The FDA approved label changes for SUBLOCADE on February 24, 2025, allowing rapid initiation of treatment after a single dose of transmucosal buprenorphine[114]. - SUBLOCADE can now be administered subcutaneously in multiple sites, enhancing flexibility for patients and healthcare providers[115]. - The company is developing INDV-2000, a non-opioid treatment for moderate to severe opioid use disorder (OUD), with a Phase 2 study expected to complete by the end of 2025[139]. - INDV-6001, a sustained release long-acting injectable prodrug of buprenorphine, has secured global rights with an upfront payment of 5 million option payment, with U.S. patents expiring in 2039[140]. Financial Agreements and Investments - The company agreed to make payments totaling 100 million on November 17, 2023, completing it on August 2, 2024, repurchasing 5,944,547 shares at an average price of approximately 101 million was announced on July 25, 2024, which commenced on August 5, 2024, and completed on January 31, 2025, repurchasing 9,415,726 shares at an average price of approximately 400 million in senior secured notes, including 32 million contract was awarded to the company by BARDA to support post-marketing studies and procurement of OPVEE as a medical countermeasure[135]. - The company has coverage from approximately 90% of payors for its OUD products, including nearly all commercial insurance payors and government programs[160]. Regulatory and Compliance - The FDA user fee rate for NDA submissions in fiscal year 2024 is set at 2,155,002[205]. - For fiscal year 2025, the user fee rate for ANDA submissions by large size operation generic applicants is set at $1,891,664[207]. - The FDA requires all NDAs to include assessments on drug safety and effectiveness in pediatric patients unless a waiver is granted[202]. - The FDA may impose civil penalties on drug manufacturers that fail to implement an approved Risk Evaluation and Mitigation Strategy (REMS)[213]. - The SUBOXONE Film and SUBLOCADE Injection are subject to specific REMS programs to mitigate risks associated with their use[214]. - The FDA enforces comprehensive current Good Manufacturing Practices (cGMP) to ensure drug quality and safety throughout the manufacturing process[216]. - The FDA conducts pre-approval and post-approval inspections to ensure compliance with cGMP, impacting drug approval processes[217]. - Pharmaceutical manufacturers must report adverse events during clinical trials and post-approval, with specific reporting timelines for serious events[219]. - The FDA regulates marketing and labeling of pharmaceuticals to prevent false claims, requiring manufacturers to submit promotional materials[220]. - The DEA enforces strict regulations on controlled substances, complicating the import of finished dosage forms from outside the U.S.[225]. - Compliance with federal and state healthcare laws is critical, as violations can lead to significant penalties and operational disruptions[244]. - The Sunshine Act requires pharmaceutical companies to report payments and transfers of value to healthcare providers, enhancing transparency[242]. Market Trends and Challenges - The company faces competition from four generic competitors for SUBOXONE Film in the U.S., with a fifth expected in early 2025[61]. - The company faces competition from generic products and alternative treatments, impacting market share and pricing of its branded products[127]. - The company focuses its sales and marketing efforts on diverse treatment environments, including emergency rooms, hospitals, and rehabilitation centers[157]. - The company has begun offering OPVEE to government entities and community agencies, utilizing grant funding related to the opioid epidemic[162]. - The company has established strong marketing expertise in increasing disease state and treatment awareness through various platforms[179]. - The company faces challenges in the sales process due to the regulatory nature of its products, including the requirement for secure storage and administration by healthcare providers[180]. - Legislative changes may continue to pressure drug pricing and reimbursement methodologies, affecting the pharmaceutical industry's financial outlook[234]. Social Impact and Community Programs - The INSUPPORT Community Reentry Program reached over 100 enrollments in 2023, providing eligible patients with up to two months of SUBLOCADE at no cost while awaiting health insurance reinstatement[104]. - The U.S. Department of Justice issued guidance in April 2022 emphasizing the rights of individuals with opioid use disorder (OUD) to receive treatment, including in correctional settings[108]. - The company collaborates with patient organizations and stakeholders to expand access to evidence-based treatment for substance use disorders[172]. - In 2023, 48.5 million people aged 12 or older (17%) had a substance use disorder (SUD) in the past year, including 28.9 million with an alcohol use disorder and 27.2 million with a drug use disorder[86]. - The U.S. experienced 97,000 fatal overdoses in the 12 months ending July 2024, with 67,952 linked to natural and synthetic opioids[83]. - The European market for opioid use disorder treatment is smaller than the U.S., with an estimated 860,000 high-risk opioid users reported in 2024[93].