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Indivior PLC (INDV.L)

INDV.L on London Stock Exchange

202.40GBp
16 Nov 2018
Change (% chg)

-3.60 (-1.75%)
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Latest Key Developments (Source: Significant Developments)

Indivior Cuts FY Sublocade Rev Forecast To $8 Mln - $10 Mln
Wednesday, 26 Sep 2018 

Sept 26 (Reuters) - Indivior PLC ::INDIVIOR PROVIDES BUSINESS UPDATE.REVISED FY 2018 GUIDANCE OF NET REVENUE OF $990-$1,020 MILLION.REVISED FY 2018 NET INCOME IN A RANGE OF $230-$255 MILLION, EXCLUDING EXCEPTIONAL ITEMS AND AT CONSTANT FX..NET REVENUE EXPECTATIONS FOR SUBLOCADE ARE EXPECTED TO BE BETWEEN $8 TO $10 MILLION.SEES PRE-TAX SAVINGS OF $55 MILLION FROM COST ACTIONS GROUP IS TAKING TO STREAMLINE ORGANIZATION.SEES FINANCE EXPENSE BENEFITS FROM PREPAYMENT OF $150M OF TERM LOAN FACILITIES FOR 2018.WILL INCUR EXCEPTIONAL COSTS OF APPROXIMATELY $13 MILLION PRE-TAX IN FY 2018 TO ACHIEVE COST SAVINGS.SUBLOCADE NET REVENUE DEVELOPMENT CONTINUES TO BE IMPACTED BY INEFFICIENCIES ASSOCIATED WITH PRIOR AUTHORIZATION PROCESS ACROSS PAYORS.SUBLOCADE NET REVENUE FOR Q3 IS LIKELY TO BE IN RANGE OF $3 TO $4 MILLION.WITH SUBLOCADE, HAVE SUBSTANTIALLY UNDERESTIMATED LAG TIME ASSOCIATED WITH APPROVAL OF MEDICAL BENEFIT COVERAGE OF INDIVIDUAL PATIENTS.REMAIN CONFIDENT IN ACHIEVING PEAK SUBLOCADE™ NET REVENUE OF $1 BILLION-PLUS.LONG-TERM FUNDAMENTAL DRIVERS OF SUBLOCADE REMAIN POSITIVE.COST SAVINGS INITIATIVES EXPECTED TO GENERATE ANNUAL PRE-TAX SAVINGS RANGING FROM $80 TO $100 MILLION IN FY 2019.COST ACTIONS INCLUDE ELIMINATING TARGETED SG&A COSTS AND EXTERNAL CONSULTING SERVICES, RESIZING GLOBAL SUPPORT FUNCTIONS.COST ACTIONS INCLUDE REPRIORITIZING RESEARCH AND DEVELOPMENT ACTIVITIES.  Full Article

DURECT Announces Receipt Of $5 Mln Milestone Payment From Indivior
Thursday, 30 Aug 2018 

Aug 30 (Reuters) - DURECT Corp ::DURECT ANNOUNCES RECEIPT OF $5 MILLION MILESTONE PAYMENT FROM INDIVIOR.DURECT - PAYMENT TRIGGERED BY INDIVIOR'S APPROVAL OF NEW DRUG APPLICATION FOR PERSERIS (RISPERIDONE) IN JULY 2018.  Full Article

Indivior says US court expedites Dr Reddy Laboratories' appeal
Monday, 30 Jul 2018 

July 30 (Reuters) - Indivior PLC ::U.S. COURT OF APPEALS FOR FEDERAL CIRCUIT HAS GRANTED-IN-PART A MOTION TO EXPEDITE DR. REDDY LABORATORIES' APPEAL OF JULY 13, 2018 PRELIMINARY INJUNCTION (PI).PI, GRANTED BY DISTRICT OF NEW JERSEY, PROHIBITS DRL FROM USING, IMPORTING, SELLING, OR OFFERING TO SELL ITS GENERIC BUPRENORPHINE/NALOXONE SUBLINGUAL FILM PRODUCT.IN LIGHT OF CAFC'S DECISION TO GRANT DRL AN EXPEDITED APPEAL, INDIVIOR, AS INDICATED IN ITS H1 2018 RESULTS ANNOUNCEMENT, WILL NOW REVIEW APPROPRIATE LAUNCH TIMING FOR PERSERIS™ (RISPERIDONE) EXTENDED-RELEASE INJECTION.  Full Article

FDA Approves Perseris For Extended-Release Injectable Suspension For The Treatment Of Schizophrenia In Adults
Saturday, 28 Jul 2018 

July 27 (Reuters) - Indivior PLC ::FDA APPROVES PERSERIS™ (RISPERIDONE) FOR EXTENDED-RELEASE INJECTABLE SUSPENSION FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS.  Full Article

Top Shareholder Scopia Capital Management Raises Stake In Indivior To 16 Pct - Filing
Thursday, 26 Jul 2018 

July 26 (Reuters) - Indivior PLC ::TOP SHAREHOLDER SCOPIA CAPITAL MANAGEMENT RAISES STAKE IN INDIVIOR TO 16 PERCENT FROM 15 PERCENT EARLIER - FILING.  Full Article

Dr.Reddy's Says No Direct Financial Implication To Compensation And/Or Penalty On Patent Infringement Case With Indivior
Tuesday, 17 Jul 2018 

July 17 (Reuters) - Dr.Reddy's Laboratories Ltd ::CLARIFIES REGARDING NEWS ITEM ON PATENT INFRINGEMENT CASE WITH INDIVIOR.SAYS THERE IS NO DIRECT FINANCIAL IMPLICATION RELATING TO COMPENSATION AND/OR PENALTY.IF CO WINS ULTIMATELY, CO WILL BE REIMBURSED FOR POTENTIAL LOSSES INCURRED FOR NOT BEING ABLE TO SELL GENERIC PRODUCTS.WILL NOT REALIZE FINANCIAL BENEFITS OWING TO STOP IN SALES OF GENERIC VERSIONS OF SUBOXONE SUBLINGUAL FILM.IF CO LOSES THE CASE, THE PLATIFF MAY CLAIM LOSES ON ACCOUNT OF CO'S SALES RECORDED DURING BRIEF PERIOD BETWEEN LAUNCH DATE AND TRO DATE.  Full Article

Indivior Granted Preliminary Injunction On Generic (Buprenorphine And Naloxone) Sublingual Film
Friday, 13 Jul 2018 

July 13 (Reuters) - Indivior PLC ::INDIVIOR IS GRANTED PRELIMINARY INJUNCTION ON GENERIC (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM.INDIVIOR IS GRANTED PRELIMINARY INJUNCTION ON GENERIC (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM.U.S. DISTRICT COURT FOR DISTRICT OF NEW JERSEY HAS GRANTED A PRELIMINARY INJUNCTION (PI) AGAINST DR. REDDY'S LABORATORIES.RESTRICTIONS OF PREVIOUSLY ENTERED TEMPORARY RESTRAINING ORDER (TRO) REMAIN IN PLACE.COURT ALSO ORDERED INDIVIOR TO POST BOND TO PROVIDE SECURITY TO DRL SHOULD COURT CONCLUDE THAT '305 PATENT IS INVALID AND/OR NOT INFRINGED.DR.REDDY'S IS UNABLE TO SELL ITS GENERIC BUPRENORPHINE/NALOXONE SUBLINGUAL FILM PRODUCT, PENDING OUTCOME OF LITIGATION AGAINST DRL.COURT HAS ALSO ORDERED PARTIES TO SUBMIT A FINAL PROPOSED INJUNCTION ORDER ON MONDAY, JULY 16.  Full Article

Indivior Sees FY18 Guidance Below Expectations
Wednesday, 11 Jul 2018 

July 11 (Reuters) - Indivior PLC ::INDIVIOR SEES FY18 GUIDANCE BELOW EXPECTATIONS.INDIVIOR SEES FY18 GUIDANCE BELOW EXPECTATIONS.CANNOT RELIABLY PROVIDE UPDATED FY 2018 NET REVENUE AND ADJUSTED NET INCOME GUIDANCE UNTIL IMPACT OF DRL'S LAUNCH IS BETTER UNDERSTOOD.LOOKING AT COST SAVING OPPORTUNITIES, INITIALLY TARGETING AT LEAST $25M IN COST SAVINGS IN 2018.UNDERSTANDING IMPACT OF DRL'S LAUNCH WILL BE NO LATER THAN ITS Q3 RESULTS ANNOUNCEMENT.MAKING PROGRESS IN OVERCOMING SUBLOCADE'S EARLY STAGE CHALLENGES AND CONTINUE TO EXPECT TO DELIVER PEAK NET REVENUE OF $1BILLION-PLUS.CONTINUING TO MONITOR US MARKET DEVELOPMENTS TO BETTER GAUGE DRL'S LAUNCH IMPACT.AS A RESULT OF UNFAVOURABLE MIX IMPACT, INDIVIOR IS EXPERIENCING LOWER THAN EXPECTED NET REVENUE.COMPANY ESTIMATES A FY 2018 MINIMUM NET REVENUE IMPACT OF $50M FROM MARKET DEVELOPMENT.INDIVIOR - PREVIOUS FY 2018 FINANCIAL GUIDANCE IS NO LONGER VALID BASED ON RECENT US MARKET DEVELOPMENTS FOR SUBOXONE & EARLY UPTAKE LEVELS OF SUBLOCADE.PREVIOUS FY 2018 FINANCIAL GUIDANCE (NET REVENUE: $1,130M - $1,170M; ADJUSTED NET INCOME: $280M - $320M) IS NO LONGER VALID.INDIVIOR REMAINS CONFIDENT IN ACHIEVING PEAK SALES OF AT LEAST $1 BILLION-PLUS IN ANNUAL NET REVENUE.CANNOT RELIABLY PROVIDE UPDATED FY 2018 NET REVENUE AND ADJUSTED NET INCOME GUIDANCE UNTIL IMPACT OF DRL'S LAUNCH IS BETTER UNDERSTOOD.MAKING PROGRESS IN OVERCOMING SUBLOCADE'S EARLY STAGE CHALLENGES AND CONTINUE TO EXPECT TO DELIVER PEAK NET REVENUE OF $1BILLION-PLUS.  Full Article

Indivior - U.S. District Court Heard Co's Application For A Preliminary Injunction Against Dr. Reddy's Lab
Thursday, 28 Jun 2018 

June 28 (Reuters) - Indivior PLC ::INDIVIOR PLC - U.S. DISTRICT COURT FOR DISTRICT OF NEW JERSEY HEARD CO'S APPLICATION FOR A PRELIMINARY INJUNCTION AGAINST DR. REDDY'S LABORATORIES.  Full Article

Indivior Enters Into Settlement With Par Pharmaceutical in Patent Infringement Case
Monday, 14 May 2018 

May 14 (Reuters) - Indivior PLC ::INDIVIOR SETTLEMENT WITH PAR PHARMACEUTICAL.INDIVIOR ENTERS INTO SETTLEMENT WITH PAR PHARMACEUTICAL IN PATENT INFRINGEMENT CASE.SETTLEMENT RESOLVING PATENT LITIGATION RELATED TO SUBOXONE (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM.SETTLEMENT PERMITS PAR TO BEGIN SELLING GENERIC VERSION OF SUBOXONEFILM ON JAN 1, 2023, OR EARLIER UNDER CERTAIN CIRCUMSTANCES.  Full Article