Ankündigung • May 22

Indivior Pharmaceuticals Announces Findings From Real-World Evidence Studies on Monthly Injectable Buprenorphine (SUBLOCADE)

Indivior Pharmaceuticals, Inc. announced findings from two new real-world evidence studies showing that adherence to extended-release buprenorphine, a monthly injectable commercially available as SUBLOCADE®, is associated with lower relapse risk, fewer infection-related complications, and reduced healthcare utilization among people living with opioid use disorder (OUD). One retrospective claims analysis, published in Drug and Alcohol Dependence Reports, analyzed 3,400 patients’ 12-month adherence rates to monthly injectable buprenorphine and its association with return to opioid use. Patients adherent to extended-release buprenorphine were 3.5 to 8.1 times less likely to return to opioid use compared to other groups who were non-adherent, or adherent to other forms of MOUD. Additional relapse risk factors included younger age, male sex, Medicaid coverage, urban residence, comorbid alcohol or other substance use disorders, skin infections, and limited prior engagement with buprenorphine treatment before initiation of the extended-release injection. A second retrospective cohort study, published in The Journal of Substance Use and Addiction Treatment, compared infectious disease outcomes and healthcare utilization between 467 patients receiving monthly injectable buprenorphine and nearly 120,000 patients on daily oral buprenorphine. Patients adherent to extended-release buprenorphine had a 62% reduction in bacteremia incidence (bloodstream infections) compared to those adherent to oral buprenorphine. Furthermore, patients in the extended-release buprenorphine group had lower overall healthcare utilization during the 6-month follow-up. This included 56% fewer inpatient visits, 22% fewer ED visits, 21% fewer all-cause outpatient visits, and 77% fewer sexually transmitted infections-related outpatient visits. As both studies were retrospective real-world evidence analyses using existing claims and electronic health record data, these findings should be viewed in the context of the study designs and data-source possibilities. Findings from the relapse analysis, published in Drug and Alcohol Dependence Reports, are available. Relapse was identified using claims-based proxy measures, and some treatment or outcome events may not have been fully captured in administrative claims data, including during the COVID-19 pandemic. The infectious disease and healthcare utilization analysis, published in The Journal of Substance Use and Addiction Treatment, is available. This analysis may not capture care received outside the data network. The size and duration of the extended-release cohort may limit precision for some comparisons. Both studies were funded by Indivior and conducted in partnership with external academic and research collaborators using large U.S. claims and electronic health record–linked datasets. SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII. SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY. Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Risk of Serious Injection Site Reactions: Likelihood may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema, and pruritus with some involving abscess, ulceration, and necrosis. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. Adverse reactions commonly associated with SUBLOCADE (in =5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit.

Ankündigung • Aug 03

Pomerantz Law Firm Announces the Filing of a Class Action Against Indivior PLC and Certain Officers

Pomerantz LLP announced that a class action lawsuit has been filed against Indivior PLC and certain officers. The class action, filed in the United States District Court for the Eastern District of Virginia (Richmond Division), and docketed under 24-cv-00554, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Indivior securities between February 22, 2024 and July 8, 2024, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officers. Indivior is a global pharmaceutical company that develops, manufactures, and markets drugs to treat opioid use disorders ("OUD") and serious mental illnesses. Indivior's flagship drug is SUBLOCADE, a monthly injection used to treat moderate to severe OUD. In 2023, sales of SUBLOCADE generated net revenue of $630 million, which accounted for 58% of Indivior's net revenue in 2023. Indivior also sells PERSERIS, which is an injection to treat schizophrenia in U.S. adults. In 2023, PERSERIS sales generated net revenue of $42 million. In October 2023, Indivior launched OPVEE, a nasal spray to reverse opioid overdoses on an emergency basis. In February 2024, Indivior announced its fourth quarter and full year ("FY") 2023 results and provided the following net revenue guidance for Fiscal Year 2024: (i) net revenue guidance in a range of $1.24-$1.33 billion; (ii) SUBLOCADE net revenue guidance in a range of $820-$880 million; (iii) OPVEE net revenue guidance in a range of $15-$25 million; and (iv) PERSERIS net revenue guidance in a range of $55-$65 million. Indivior reaffirmed the foregoing net revenue guidance, in whole or in part, multiple times in April, May, and June 2024. The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects. Specifically, Defendants (i) grossly overstated their ability to forecast the negative impact of certain legislation on the financial prospects of Indivior products, which forecasting ability was far less capable and effective than Defendants had led investors and analysts to believe; (ii) overstated the financial prospects of SUBLOCADE, PERSERIS and OPVEE, and thus overstated the Company's anticipated revenue and other financial metrics; (iii) knew or recklessly disregarded that because of the negative impact of certain legislation on the financial prospects of Indivior's products, Indivior was unlikely to meet its own previously issued and repeatedly reaffirmed Fiscal Year 2024 net revenue guidance, including its Fiscal Year 2024 net revenue guidance for SUBLOCADE, PERSERIS and OPVEE; (iv) knew or recklessly disregarded that Indivior was at a significant risk of, and/or was likely to, cease all sales and marketing activities related to PERSERIS; and (v) knew or recklessly disregarded that, as a result of the foregoing, the Company's public statements were materially false and misleading at all relevant times. On July 9, 2024, Indivior issued a press release "announc[ing] a business update encompassing [its] outlook for [second quarter ('Q2')] and Fiscal Year 2024 financial performance" ("July 9 Update"). The July 9 Update reduced Fiscal Year 2024 (i) total net revenue guidance to $1.15-$1.215 billion from the previous range of $1.24-$1.33 billion; (ii) SUBLOCADE net revenue guidance to $765-$805 million from the previous range of $820-$880 million; and (iii) OPVEE net revenue guidance to $9-14 million from the previous range of $15-25 million. The July 9 Update also shockingly advised that the Company would immediately cease all sales and marketing activities related to PERSERIS. The July 9 Update explained that the reduction in guidance of SUBLOCADE net revenue for Fiscal Year 2024 resulted in major part from accelerated Medicaid disenrollments at the end of Second Quarter 2024. The July 9 Update further explained that the cessation of the marketing and sale of PERSERIS was due to the highly competitive market "and impending changes that are expected to intensify payor management in the treatment category in which PERSERIS participates," which led the Company to conclude that "there is no longer a path forward for PERSERIS that is financially viable." Finally, the expected adoption of OPVEE had lagged expectations. Upon the above news and further commentary by Defendants on a subsequent conference call, Indivior's stock price fell $5.15 per share, or 33.57%, to close at $10.19 per share on July 9, 2024.

Gesamte Aktionärsrendite	3.0%
Zukünftige Dividendenrendite	0%
Wachstum der Dividende	n/a
Nächster Dividendenzahlungstermin	n/a
Ex-Dividendendatum	n/a
Dividende pro Aktie	n/a
Ausschüttungsquote	0%

Segment	Dividendenrendite
Unternehmen (INDV)	0%
Untere 25 % des Marktes (US)	1.4%
Markt Top 25 % (US)	4.2%
Branchendurchschnitt (Pharmaceuticals)	1.9%
Analystenprognose (INDV) (bis zu 3 Jahre)	0%

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/07/14 01:29
Aktienkurs zum Tagesende	2026/07/14 00:00
Gewinne	2026/03/31
Jährliche Einnahmen	2025/12/31

Paket	Daten	Zeitrahmen	Beispiel US-Quelle ^*
Finanzdaten des Unternehmens	10 Jahre	Gewinn- und Verlustrechnung Kapitalflussrechnung Bilanz	SEC-Formular 10-K SEC-Formular 10-Q
Konsensschätzungen der Analysten	+3 Jahre	Finanzielle Vorausschau Kursziele der Analysten	Analysten Research Berichte Blue Matrix
Marktpreise	30 Jahre	Aktienkurse Dividenden, Splits und Aktionen	ICE-Marktdaten SEC-Formular S-1
Eigentümerschaft	10 Jahre	Top-Aktionäre Insiderhandel	SEC-Formular 4 SEC-Formular 13D
Verwaltung	10 Jahre	Das Führungsteam Direktorium	SEC-Formular 10-K SEC-Formular DEF 14A
Wichtige Entwicklungen	10 Jahre	Ankündigungen des Unternehmens	SEC-Formular 8-K

Analyst	Einrichtung
Glen Santangelo	Barclays
Graham Glyn Parry	BofA Global Research
Chase Knickerbocker	Craig-Hallum Capital Group LLC

Indivior Pharmaceuticals Ausschüttungen und Rückkäufe

Zukünftiges Wachstum Kriterienprüfungen 0/6

Wichtige Informationen

Jüngste Updates zu Dividenden und Rückkäufen

Indivior PLC (LSE:INDV) announces an Equity Buyback for 13,649,017 shares, for $100 million.

Indivior PLC (LSE:INDV) announces an Equity Buyback for 13,631,504 shares, for $100 million.

Recent updates

INDV: Turnaround Plan And Index Additions Will Drive Earnings Momentum

Indivior Ends Two Drug Programs to Refocus on Core Opioid Use Disorder Treatments

INDV: Raised Guidance And Buybacks Will Support A Turnaround Repricing

Indivior Pharmaceuticals (INDV) Stock Could Be 23% Undervalued As Cost Cut Narrative Builds

Indivior Ups 2026 Outlook as SUBLOCADE Drives Revenue Growth and Share Buybacks

Indivior: A Stronger Business Than When I First Covered It

Indivior Pharmaceuticals Announces Findings From Real-World Evidence Studies on Monthly Injectable Buprenorphine (SUBLOCADE)

Indivior Q1 Results Surpass Expectations With SUBLOCADE Growth and US$175m Share Buyback

Indivior Pharmaceuticals, Inc. Raises Earnings Guidance for the Fiscal Year 2026

Indivior Pharmaceuticals, Inc. to Report Q1, 2026 Results on Apr 30, 2026

Indivior Pharmaceuticals, Inc. Announces Findings From Cost Impact Model For Monthly Injectable Buprenorphine

Indivior Pharmaceuticals, Inc., Annual General Meeting, May 13, 2026

Indivior Pharmaceuticals, Inc. Reaffirms Earnings Guidance for the Full-Year 2026

Indivior Pharmaceuticals, Inc. to Report Q4, 2025 Results on Feb 26, 2026

Indivior PLC Provides Earnings Guidance for the Full Year 2026

Indivior Presents New Real-World Evidence At AMCP Nexus 2025 Demonstrating Clinical and Economic Benefits of Adherence to Monthly Injectable Buprenorphine

Indivior PLC Raises Earnings Guidance for the Year 2025

Indivior PLC to Report Q3, 2025 Results on Oct 30, 2025

Indivior PLC Publishes Completes Results from a Multicenter, Open-Label Clinical Trial Published in JAMA Network Open

Indivior Proposes New Corporate Structure to Achieve U.S. Domiciliation

Indivior PLC Revises Earnings Guidance for the Year 2025

Indivior Announces Completion of Cancellation of Secondary Listing on London Stock Exchange

Indivior PLC Announces Real World Evidence Study Finds Medications for Opioid Use Disorder, Particularly Extended-Release Buprenorphine, Reduced Odds of Emergency Department Visits for Patients with Opioid Use Disorder

Indivior PLC to Report Q2, 2025 Results on Jul 31, 2025

Indivior Appoints Vanessa Procter as Executive Vice President of Corporate Affairs, Effective July 7, 2025

Indivior PLC Appoints Tony Kingsley as Independent Non-Executive Director, Effective July 1, 2025

Indivior PLC Presents New Data at CPDD Demonstrating That High Buprenorphine Exposure May Improve Treatment Outcomes in High Fentanyl Users

Indivior Intends to Cancel LSE Listing

High number of new directors

Addex Partner Indivior Advances GABAB Positive Allosteric Modulator Program Successfully Through Ind Enabling Studies

Indivior: Trying To Break Addiction

New major risk - Negative shareholders equity

First quarter 2025 earnings: EPS and revenues exceed analyst expectations

Indivior PLC, Annual General Meeting, May 08, 2025

Indivior PLC Announces Appointment of Joe Ciaffoni as Chief Executive Officer

Indivior PLC Announces Board and Board Committee Changes

Independent Non-Executive Director recently bought US$504k worth of stock

Indivior PLC Announces Stepping Down of Mark Crossley as Chief Executive Officer

Indivior Announces FDA Approval of Label Changes for SUBLOCADE (Buprenorphine Extended-Release) Injection

Indivior plc Provides Revenue Guidance for the Year 2025

Full year 2024 earnings: Revenues exceed analysts expectations while EPS lags behind

Indivior PLC Announces Delayed FDA Approval of SUBLOCADE® Label Changes

Indivior PLC to Report Q4, 2024 Results on Feb 20, 2025

Indivior PLC Appoints Daniel A. Ninivaggi to the Board as an Independent Non-Executive Director

Indivior plc Appoints David Wheadon as Chair of the Board and Chair of the Nomination Committee

High number of new directors

Independent Non-Executive Director recently bought US$251k worth of stock

Indivior PLC Announces Ryan Preblick Steps Down as Chief Financial Officer

Indivior PLC Shares Results from a Randomized, Open-Label Sub-Study in Opioid-Dependent Participants Seeking Treatment

Jerome Lande to Step Down from the Board of Indivior plc

Oaktree Capital Sends a Letter to Indivior PLC

Third quarter 2024 earnings: Revenues exceed analysts expectations while EPS lags behind

Indivior: This Value Stock Has Over 100% Upside Potential If Market Share Stabilizes In 2025

Indivior PLC Revises Financial Guidance for the Fiscal Year 2024

Price target decreased by 18% to US$19.33

Indivior PLC's SUBLOCADE® Rapid Induction/Alternative Injection Site Prior Approval Supplement (PAS) Receives FDA Priority Review

Indivior PLC Announces Retirement of Graham Hetherington as Chair and from the Board

Indivior PLC Provides Update on Aelis Farma's Clinical Phase 2B Study Results with AEF0117 in Participants with Moderate to Severe Cannabis Use Disorder

Addex Therapeutics Ltd and Indivior PLC Selects Clinical Candidates from Gabab Positive Allosteric Modulator Research Collaboration

Pomerantz Law Firm Announces the Filing of a Class Action Against Indivior PLC and Certain Officers

Second quarter 2024 earnings: Revenues exceed analysts expectations while EPS lags behind

Indivior PLC (LSE:INDV) announces an Equity Buyback for 13,649,017 shares, for $100 million.

Indivior: Management Takes Advantage Of Sell-Off As Board Approves Another $100m Buyback

Indivior PLC Provides Revenue Guidance for the Second Quarter of 2024

Indivior PLC(LSE:INDV) dropped from FTSE 350 (Ex Investment Companies) Index (GBP)

Indivior PLC Announces the Publication of New Data on the Comparative Effectiveness of Intranasal (IN) Nalmefene (Ovee 2.7Mg) and In Naloxone (4 Mg) in a Translational Model Assessing the Impact of a Synthetic Opioid Overdose on Respiratory Depression on Respiratory Depression

Indivior PLC Announces Dosing of First Subject with Indv-2000 in A Phase 2 Study Assessing the Safety and Efficacy of Indv-2000 in Individuals with Opioid Use Disorder

Indivior plc Reaffirms Revenue Guidance for the Year 2024

Indivior PLC Announces Board Committee Changes

Indivior plc Reconfirms Earnings Guidance for 2024

First quarter 2024 earnings: EPS and revenues miss analyst expectations

Indivior PLC Appoints David E. Wheadon, M.D. as Independent Non-Executive Director, Effective from June 1, 2024

Indivior PLC to Report First Half, 2024 Results on Jul 25, 2024