Indivior PLC(US: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 $756 million for SUBLOCADE and $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 $10 million and a $5 million option payment, with U.S. patents expiring in 2039[140]. Financial Agreements and Investments - The company agreed to make payments totaling $600 million to federal and state authorities as part of a resolution agreement with the DOJ[72]. - Indivior commenced a share repurchase program of up to $100 million on November 17, 2023, completing it on August 2, 2024, repurchasing 5,944,547 shares at an average price of approximately $16.96[77]. - A new non-discretionary share repurchase program of $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 $10.71, representing about 6.4% of diluted shares outstanding[78]. - On November 4, 2024, Indivior repaid the outstanding balance under its existing credit agreement and entered into a Note Purchase Agreement for the issuance of up to $400 million in senior secured notes, including $350 million in term notes[79]. - A $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 $4,310,002, while for NDAs not requiring clinical data, it is $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].