Strengthening our global leadership in treatment of addiction · US Roadshow 2016 September 2016....
Transcript of Strengthening our global leadership in treatment of addiction · US Roadshow 2016 September 2016....
StrengtheningourgloballeadershipintreatmentofaddictionUSRoadshow2016
September2016
ForwardLookingStatements
This presentation contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions,in light of the safe harbour provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward-lookingstatements involve risk and uncertainty as they relate to events or circumstances that will or may occur in the future. Actual results maydiffer materially from those expressed or implied in such statements because they relate to future events. Forward-looking statementsinclude, among other things, statements regarding our financial guidance for 2016 and our medium- and long-term growth outlook, ouroperational goals, our product development pipeline and statements regarding ongoing litigation.
Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of SuboxoneTablet, Suboxone Film, Subutex Tablet and any future products; the outcome of research and development activities; decisions by regulatoryauthorities regarding the Indivior Group’s drug applications; the speed with which regulatory authorizations, pricing approvals and productlaunches may be achieved; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing;the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcarecost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concernsthat may arise regarding the safety or efficacy of the Indivior Group’s products and product candidates; risks related to legal proceedings;the Indivior Group’s ability to protect its patents and other intellectual property; the outcome of the Suboxone Film patent litigation relatingto the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational andstaff functions to third parties; uncertainties related to general economic, political, business, industry, regulatory and market conditions; andthe impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items.
This presentation does not constitute an offer to sell, or the solicitation of an offer to subscribe for or otherwise acquire or dispose of sharesin the Company to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.
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HalfYearHighlightsFinancialsAbovePlan
• NR $531m
• OpProfit $198m
• NetIncome $107m
• EPS 15c
• Cash $577m
• NetDebt ($5m)
OperationallyStrong• USmarketgrowthinmidtohigh
singledigits
• SecondconsecutivequarterofnetrevenuegrowthinUSA
• Suboxone®Filmshareat61%slightlyaheadyeartodate.
• ResilienceunderlinedbyANDAlitigationresult
• Separationvirtuallycompletewithnodisruption.
PipelineContinuingProgress• BuprenorphineMonthlyDepot
positivePhase3trialefficacytop-lineresults– meetingbothprimaryandsecondaryendpointsvsplacebo.
• RisperidoneMonthlyDepot–safetyextensionresultsdueQ4.
• ArbaclofenPlacarbilforalcoholusedisorder– captargetdosewelltoleratedbutsomeindividualvariabilityinPKlevelsobserved
GuidanceforFullYearRaisedNRguidanceincreasedbyatleast5%,
NetIncomeguidanceincreasedbyatleast10% 3
WhatwesaidinFebruary… Whatwearesayingnow
CurrentAssumptionsfor2016• Nomaterialchangeincurrentmarketconditions;ü nodeteriorationingenerictabletpricing;ü limitedimpactofbrandedcompetitionü nogenericfilmentryin2016.ü modestlossofUSshareduetoformularychanges&managed
Medicaidaccountslostin2015
• Reinvestmentof>$35mofthegrossprofitaboveoriginalassumptionsindrivinginnovations:-
ü BuprenorphineMonthlyDepot
• Atconstantexchangerates
• EstimatedTaxchargeof25%+$19mexceptionaltaxcharges
Atthemoment,themarkettrendscontinue• SomeslightdeteriorationinGenerictabletpricing• NomajorchangeinmarketshareforSuboxone Film• Nomajorincreasesinrebatinglevelstoretainformulary
ButsomecautionsforH2.• Existinggenericdiscountscouldmovefurtherandfaster• Launchofmoregenericspossible• AdditionalcompetitorinProbuphine nowonmarket• NextroundoflitigationwithANDAfilersinNovember
Increasedlegalexpensesassociatedwithlitigation/investigations
WewillupdateatQ3resultson2nd November.
BasisforGuidancefor2016
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Guidancefor2016
Guidanceisbasedon• Nomaterialchangeincurrentmarket
conditions;ü nodeteriorationingenerictabletpricing;ü limitedimpactofbrandedcompetitionü nogenericfilmentryin2016.ü modestlossofUSshareduetoformularychanges&managed
Medicaidaccountslostin2015
PreviousGuidance Delta NewGuidance
NetRevenue $945m-$975m $25m- $55m $1,000m-$1,030m
NetIncome(adjusted) $155m- $180m $20m-$25m $180m-$200m
• Reinvestmentof>$35mofthegrossprofitaboveoriginalassumptionsindrivinginnovations:-
ü BuprenorphineMonthlyDepot
• ExcludingExceptionalItems($14myeartodate)
• Atconstantexchangerates(toestimated2015averages)
• Estimatedtaxchargeof25%plusexceptionaltaxcharges 5
GenericBup/NalTablet:MarketShare NomajorshiftindiscountssinceQ12016
• Teva continuetobuilduptheirshareofthegenericmarket
• Akorn/Hi-techmakingrelativelylittleimpactsofar
• Othergenericcompanyshareshavestabilisednow.
Sohasanythingchanged?
27.1%
33.6%
28.2%
10.2%
0.8%0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
ACTAVISPHARMA AMNEALPHARMA WEST-WARD/ROXANE TEVA AKORN/HI-TECH
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60.6%
19.0%
14.9%4.8%
0.7%0%5%
10%15%20%25%30%35%40%45%50%55%60%65%70%75%
SUBOXONEFILM SUBOXONETABLET GENERICBUP GENERICBUP/NAL ZUBSOLV BUNAVAIL
Competitionisintensifying,butFilmsharehasbeenresilient
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EuropeEuropeanshareperformancecontinuestobeextremelyresilient
Marketgrowth– austeritymeasuresadrag• Pricegapsversusgenericsareachallengeinsome
markets
OpioidPainkillerDependencemarketremainsanopportunitylong-term• Challengesremaintoaccessingtheopportunity
• Trialscontinuingbuttooearlytoreportanyresults
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
Q111
Q211
Q311
Q411
Q112
Q212
Q312
Q412
Q113
Q213
Q313
Q413
Q114
Q214
Q314
Q414
Q115
Q215
Q315
Q415
Q116
TotalINDV%shareBUPE Subutex%Share(ofBupe)
Suboxone%share(ofBupe) Generic%share(ofBupe)
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PreserveleadershippositioninUSAagainst5genericand3brandedcompetitors
IndiviorPLC– Prioritiesfor2016
1.SuboxoneFilmResilience
• Newtreatmentareasofaddictionandrelatedmorbidities
• ExpandtreatmentaccessinUSA
• OpioidpainkillerdependenceinEurope
• FileNDAinChina
4.ExpandGlobaltreatment
• TransformationallifecycleproductsforBuprenorphine
• Treatmentsforotheraddictionsandaddictionrescue
2.Developthepipeline
• Expandbusiness
• diversifybusinessrisk
throughtargetedbusinessdevelopment
USListingprocessunderway
3.FinancereadyforBD/M&A
ResolveANDAlitigationandsecurelong-termcertaintyforCompany
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• Ontime(2togo)• Onbudget• Nodisruption
PlusstandaloneITinfrastructureinallcountriesbyJan2016
OperatingFineChemicalplantfrom4/2015
Companytradingnamechangesfor36of41countries(5byend2016)
NewR&DlaboratorybuildprojectinHullproceedingaheadofplan
FullystaffedforstandalonePLClife
AppropriatecomplianceandregulatoryinfrastructureforcompanysellingScheduleIIIdrugs• (lastlicencetransfersOctin
Switzerland).
Separationalmostcomplete
SAPImplemented57entities/countries
ManufacturingandSupplyChain
Capabilities
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2014-2016Buildingfit-for-purposeasPLC
Firstprioritywastogetitright• separationfromRB• standalonePLCfunctions• appropriatecomplianceandregulatory
infrastructureforacompanysellingascheduleIIIdrug
• SAPimplementation,• takingcontrolofsupply/FineChemical
Plant
Nowoptimisingwhatwehave• WehaveinitiatedaprojectinH22016
• Wearebenchmarkingcostsagainstappropriatecomparators
• Wearelookingatoptimizingourstructure
Wewillreportmoreinduecourse
CostSavingInitiative2016
2016forward:OptimizingtheOrganisation
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PatientCapraisedto275- butwithabilityforstatestoenactlowercap
- Onlyifphysicianhasadditionalcredentialingstatusorhasaqualifiedpractice.
- Onlyasmallminorityofdoctorstodayatorevenclosetothe100patientcap–probablycomfortablyunder10%ofwaivereddoctors
- Ofthese,manywillchoosenottogothroughtheextraburdenorwillnotseeenoughadditionaldemandintheirareas
NursePractitioners&PhysicianAssistantstobeallowedtoprescribe- Upto30patientsinyearone,upto100patientsthereafter
- Afteratleast24hoursofprofessionaltraining
- Undersupervisioninsomestatesorinconjunctionwithqualifiedphysician
- 12monthsbeforetheeducation/trainingiscreatedandwestarttoseethefirstnurses/assistantswaivered.
- Secretarygivenpowertoexcludedirectlyadministereddrugsinthephysicians’officefromthecap.
MarketGrowthassistedbygovernmentfocus&legislationPatientCap NursePractitioners/Assistants DirectlyAdministeredDrugs
Net,weseethisasincreasingmarketgrowthbyalowsingledigitpercentage.Incrementalgrowthbutnotagamechanger. 12
Agendafor2016– 2Date Activity EventQ3Q3 ArbaclofenPlacarbilforAlcoholusedisorder FinalCSRphase2Astudy(RB-US-14-0001)July29 HalfYearResults PresentationinLondonAug RBP7000RisperidoneDepot Pre-NDAmeetingAug RBP6000BuprenorphineDepot Topline resultsofPhase3efficacyclinicaltrialSept12 MorganStanleyConference PresentationinNewYork
Q4Q4 RBP6000BuprenorphineDepot SafetyTrial(RB-US-13-0003)databaselockforinterimanalysisQ4 RBP7000RisperidoneDepot Phase3safetytrial(RB-US-13-0005)lastsubjectlastvisitQ4 Suboxone TabletChina NDAfilingNov2 Q3Results ConferenceCallNov TrialvActavis/Par/Teva ProcessPatent litigationNov ANDATrialvTeva Teva ANDAlitigation(OrangeBook-ListedPatents)Nov JefferiesConference MeetingsinLondonDec7 CitibankConference MeetingsinNewYorkDec9 R&DDay PresentationsinNewYork,LiveWebcast
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Wefacethefuturewithrenewedconfidence
Wearemakingprogressin
managingtheriskstothebusiness
Welookforwardtocontinuingour
progress
Summary
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IndicationSUBOXONE® (buprenorphineandnaloxone)SublingualFilm(CIII)isaprescriptionmedicineindicatedfortreatmentofopioiddependenceand shouldbeusedaspartofacompletetreatmentplantoincludecounselingandpsychosocialsupport.TreatmentshouldbeinitiatedunderthedirectionofphysiciansqualifiedundertheDrugAddictionTreatmentAct.IMPORTANTSAFETYINFORMATIONIndicationSUBOXONE® (buprenorphineandnaloxone)SublingualFilm(CIII)isaprescriptionmedicineindicatedfortreatmentofopioiddependenceand shouldbeusedaspartofacompletetreatmentplantoincludecounselingandpsychosocialsupport.TreatmentshouldbeinitiatedunderthedirectionofphysiciansqualifiedundertheDrugAddictionTreatmentAct.ImportantSafetyInformationDonottakeSUBOXONEFilmifyouareallergictobuprenorphineornaloxoneasseriousnegativeeffects,includinganaphylacticshock,havebeenreported.SUBOXONEFilmcanbeabusedinamannersimilartootheropioids,legalorillicit.SUBOXONEFilmcontainsbuprenorphine,anopioidthatcancausephysicaldependencewithchronicuse.Physicaldependenceisnotthesameasaddiction.Yourdoctorcantellyoumoreaboutthedifferencebetweenphysicaldependenceanddrugaddiction.DonotstoptakingSUBOXONEFilmsuddenlywithouttalkingtoyourdoctor.Youcouldbecomesickwithuncomfortablewithdrawalsymptomsbecauseyourbodyhasbecomeusedtothismedicine.SUBOXONEFilmcancauseseriouslife-threateningbreathingproblems,overdoseanddeath,particularlywhentakenbytheintravenous(IV)routeincombinationwithbenzodiazepinesorothermedicationsthatactonthenervoussystem(ie,sedatives,tranquilizers,oralcohol).Itisextremelydangeroustotakenonprescribed benzodiazepinesorothermedicationsthatactonthenervoussystemwhiletakingSUBOXONEFilm.YoushouldnotdrinkalcoholwhiletakingSUBOXONEFilm,asthiscanleadtolossofconsciousnessorevendeath.Deathhasbeenreportedinthosewhoarenotopioiddependent.Yourdoctormaymonitorliverfunctionbeforeandduringtreatment.SUBOXONEFilmisnotrecommendedinpatientswithseverehepaticimpairmentandmaynotbeappropriateforpatientswithmoderatehepaticimpairment.However,SUBOXONEFilmmaybeusedwithcautionformaintenancetreatmentinpatientswithmoderatehepaticimpairmentwhohaveinitiatedtreatmentonabuprenorphineproductwithoutnaloxone.KeepSUBOXONEFilmoutofthesightandreachofchildren.AccidentalordeliberateingestionofSUBOXONEFilmbyachildcan causeseverebreathingproblemsanddeath.DonottakeSUBOXONEFilmbeforetheeffectsofotheropioids(eg,heroin,hydrocodone,methadone,morphine,oxycodone)havesubsidedasyoumayexperiencewithdrawalsymptoms.InjectingtheSUBOXONEFilmproductmaycauseseriouswithdrawalsymptomssuchaspain,cramps,vomiting,diarrhea,anxiety,sleepproblems,andcravings.BeforetakingSUBOXONEFilm,tellyourdoctorifyouarepregnantorplantobecomepregnant.IfyouarepregnantorbecomepregnantwhiletakingSUBOXONEFilm,alertyourdoctorimmediatelyandyoushouldreportitusingthecontactinformationprovidedbelow.*Neonatalopioidwithdrawalsyndrome(NOWS)isanexpectedandtreatableoutcomeofprolongeduseofopioidsduringpregnancy, whetherthatuseismedically-authorizedorillicit.Unlikeopioidwithdrawalsyndromeinadults,NOWSmaybelife-threateningifnotrecognizedandtreatedintheneonate.HealthcareprofessionalsshouldobservenewbornsforsignsofNOWSandmanageaccordingly.BeforetakingSUBOXONEFilm,talktoyourdoctorifyouarebreastfeedingorplantobreastfeedyourbaby.TheactiveingredientsofSUBOXONEFilmcanpassintoyourbreastmilk.YouandyourdoctorshouldconsiderthedevelopmentandhealthbenefitsofbreastfeedingalongwithyourclinicalneedforSUBOXONEFilmandshouldalsoconsiderany potentialadverseeffectsonthebreastfedchildfromthedrugorfromtheunderlyingmaternalcondition.Donotdrive,operateheavymachinery,orperformanyotherdangerousactivitiesuntilyouknowhowSUBOXONEFilmaffectsyou.BuprenorphineinSUBOXONEFilmcancausedrowsinessandslowreactiontimesduringdose-adjustmentperiods.CommonsideeffectsofSUBOXONEFilmincludenausea,vomiting,drugwithdrawalsyndrome,headache,sweating,numbmouth,constipation,painfultongue,rednessofthemouth,intoxication(feelinglightheadedordrunk),disturbanceinattention,irregularheartbeat,decreaseinsleep,blurredvision,backpain,fainting,dizziness,andsleepiness.ThisisnotacompletelistofpotentialadverseeventsassociatedwithSUBOXONEFilm.PleaseseefullPrescribingInformation foracompletelist.*ToreportnegativesideeffectsassociatedwithtakingSUBOXONEFilm,pleasecall1-877-782-6966.YouareencouragedtoreportnegativesideeffectsofprescriptiondrugstotheFDA.Visitwww.fda.gov/medwatch orcall1-800-FDA-1088.FormoreinformationaboutSUBOXONEFilm,SUBOXONE® (buprenorphineandnaloxone)SublingualTablets(CIII),orSUBUTEX® (buprenorphine)SublingualTablets(CIII),pleaseseetherespectivefullPrescribingInformation andMedicationGuideatwww.suboxoneREMS.com.
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StrengtheningourgloballeadershipinAddictionTreatment
- Litigationupdate- Pipelineupdate- FinancialResults– HalfYear
BackUp
LitigationUpdate
ANDALitigation Trial against Alvogen in the lawsuit involving the Orange Book-listedpatents and the ‘497 process patent for Suboxone® Film scheduled forApril 2017, with Alvogen’s 30-month stay of FDA approval expiringOctober 29th, 2017.
By a Court order dated August 22nd, 2016, Indivior’s Suboxone® Film patentlitigation against Sandoz has been dismissed without prejudice becauseSandoz is no longer pursuing Paragraph IV certifications for its proposedgeneric formulations of Suboxone® film.
Trial against Mylan in the lawsuit involving the Orange Book-listedpatents for Suboxone® Film is scheduled for September 25th, 2017,with Mylan’s stay expiring March 24, 2018.
Indivior received a Paragraph IV notification from Teva, datedFebruary 8, 2016, indicating that Teva had filed a 505(b)(2) New DrugApplication (NDA) for a 16mg/4mg strength ofBuprenorphine/naloxone sublingual film. The Indivior Group and Tevaagreed that infringement by Teva’s 16 mg/4 mg dosage strength willbe governed by the infringement ruling on the accused 8 mg/2 mgdosage strength in its ANDA currently scheduled for trial in November2016.
The USPTO declined to institute Teva’s petitions for inter partesreview of the three Orange Book-listed patents on proceduralgrounds.
Dr. Reddy’s has filed an inter partes review petition on each of thethree Orange Book Patents. These petitions are substantively similarto those filed by Teva.
The ruling after trial against Actavis and Par in the lawsuit involving theOrange Book-listed patents for Suboxone® Film issued on June 3rd,2016. Ruling found the asserted claims of the ‘514 patent valid andinfringed; the asserted claims of the ‘150 patent valid but not infringed;and the asserted claims of the ‘832 patent invalid, but found thatcertain claims would be infringed if they were valid.
Based on the ruling as to the ’514 patent, Actavis and Par are currentlyenjoined from launching a generic product. Par has appealed andActavis is expected to appeal this ruling. The generics have also movedto reopen the judgment based on a more stringent claim construction inthe Teva case. In light of the motions to reopen, Par’s appeal has beendeactivated until the District Court rules on the motions, and thedeadlines for Actavis to file a notice of appeal has been postponed.
Trial against Teva, Actavis and Par in the lawsuits involving the recentlygranted process patent (US Patent No. 8,900,497) scheduled forNovember 2016.
Trial against Teva in the lawsuit involving the Orange Book-listedpatents for Suboxone® Film scheduled for November 2016, with Teva’s30-month stay of FDA approval on ANDA No. 20-5806 expiring April17th, 2017. Indivior believes Teva’s 30-month stay of FDA approval onANDA No. 20-5299 also expires on April 17th, 2017, however, Tevadisputes the applicability of the stay to this ANDA. We expectDr.Reddy’s Laboratories, who recently acquired these ANDAs from Teva,to substitute for Teva in these trials. 19
The Judge overseeing the legal privilege dispute in the FTCinvestigation has appointed a Special Master (anindependent external lawyer) to investigate the claims oflegal privilege and provide a recommendation to the Courton how the documents at issue should be treated. An initialreport and recommendation relating to the first tranche ofprivileged documents reviewed by the Special Master wasfinalized in April 2016 and adopted by the Court on August1st, 2016. Pursuant to this report and the Court’s order,Indivior produced certain additional documents. A secondtranche of documents remains under review. Followingthat review, the Court’s decision then may be subject toappeal by either party.
FTCInvestigation
• Fact discovery is continuing in the Class Action litigation.
• In August 2015, the Company was informed that a contingent ofadditional states has initiated a coordinated investigation into thesame conduct that is the subject of the FTC investigation and the ClassAction litigation. The existing investigation of these same issues by theState of New York has now been incorporated within this multi-stateinvestigation. On July 1, 2016, Indivior Inc. was notified that 22 statesand the District of Columbia intend to file a complaint in the EasternDistrict of Pennsylvania alleging violations of state and federal antitrustand consumer protection laws relating to the same conduct. Thenotice indicated that additional states may decide to join in any action,and, as of August 2016, eight additional states had in fact joined.
• Amneal Pharmaceuticals LLC, a manufacturer of genericbuprenorphine / naloxone tablets, has joined the class action litigationas an additional plaintiff. Amneal's complaint contains antitrustallegations similar in nature to those set out in the class actioncomplaints, and Amneal has also alleged violations of the Lanham Act
ClassActionAntitrustLitigation
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DepartmentofJusticeInvestigation
A federal criminal grand jury investigation of Indiviorinitiated in December 2013 is continuing, andincludes marketing and promotion practices,pediatric safety claims, and overprescribing ofmedication by certain physicians. The U.S. Attorney'sOffice for the Western District of Virginia has serveda number of subpoenas relating to SUBOXONE Film,SUBOXONE Tablet, SUBUTEX Tablet, buprenorphineand our competitors, among other issues. We are inthe process of responding by producing documentsand other information in connection with this on-going investigation. It is not possible at this time topredict with any certainty or to quantify the potentialimpact of this investigation on us. We arecooperating fully with the relevant agencies andprosecutors and will continue to do so.
BDSILitigation
In October 2014, BDSI sought an inter partesreview by the U.S. Patent Office of claims 15-19of our Orange Book-listed U.S. Patent No.8,475,832. That proceeding was instituted andthe Patent Trial and Appeal Board ruled theclaims unpatentable. This decision was affirmedby the Court of Appeals for the Federal Circuit onAugust 10, 2016.
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update
ThePipeline
SUBOXONE® Tablet
Canada:AdditionalDosageStrengths§ MeetingwithHealthCanada(HC):Confirmationthatbioequivalencecriteriaweremetfor
theproposed12mg/3mgand16mg/4mgdosagestrengths.§ NDSsubmissionplansongoing.
China:NDApreparation&submission§ EfficacyStudy(RB-CN-10-0013):CompletedwithClinicalStudyReportsignedinJune2016.
§ PlannedNDAsubmission:Q4-2016.
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OPIOID USE DISORDER:RBP-6000(PHASE III)
Clinical§ PhaseIIIEfficacy&Safetytrial(RB-US-13-0001):positive toplineresultsannouncedAugust
17th,2016showingRBP-6000meetsbothprimaryandsecondaryendpointsvs.placebo(p<0.0001)
§ PhaseIIILong-TermSafetytrial(RB-US-13-0003):LastPatientFirstVisitApril2016.OntracktodeliverdatabaselockforinterimanalysisinQ42016.
Ontrackwithpreviousguidance
Regulatory§ FastTrackDesignation:GrantedMay23rd,2016.
§ Pre-NDAMeeting,Q4-2016§ PlannedNDAsubmission(pendingoutcomeofpre-NDAmeeting):Q2-2017.
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2016PEER-REVIEWED SCIENTIFIC PUBLICATIONS:RBP-6000JClinPsychopharmacol,36(1):18-26.http://dx.doi.org/10.1097/JCP.0000000000000434
§MonthlyinjectionsofRBP-6000producedclinicallyrelevantplasmalevelsofbuprenorphine(andpredictedμ-opioidreceptoroccupancyinthebrain),whichtranslatedintoanalmostcompleteblockadeofthesubjectiveeffectsofhydromorphoneandasignificantreductioninthereinforcingeffectsofhydromorphone.RBP-6000wasalsosafeandwelltolerated.
JClinPharmacol,56(7):806-815.http://dx.doi.org/10.1002/jcph.665
§TheresultsofthispopulationPKanalysisjointlywiththepredictedlevelofμ-opioidreceptoroccupancyinthebrainprovidedquantitativecriteriaforclinicalPhaseIIIdoseselectionofRBP-6000:adoseof300mgevery28dayswasappropriateforimmediatelyachievinganeffectiveexposureafterthefirstSCinjectionandtomaintaineffectivelevelsofexposureduringchronictreatment.
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RESCUE MEDICATION FOR DRUG OVERDOSE/INTOXICATION
IntranasalNaloxoneforOpioidOverdose§ TemporaryAuthorizationforUse(ATU):
ApprovedbyFrenchANSMonNov5th,2015.ATUlaunchapprovalJul26th,2016withNALSCUE® launchinFranceonJul27th,2016.
RBP-8000:CocaineEsteraseforCocaineIntoxication(PhaseII)
§ BreakthroughTherapyDesignation:GrantedOct.17th,2014.
§ SecondTypeBmeetingwiththeFDA:Mar16th,2016.
§ Clinicaldevelopmentplansunderreview.26
ALCOHOL USE DISORDER:ARBACLOFEN PLACARBIL (PHASE IIA)
§ PhaseIIAtrial(RB-US-14-0001):
ü ArbaclofenPlacarbilfoundtobesafe&welltoleratedtodosesupto240mg(cap)incontrolledabstinencesetting.
ü Highinter-individualPKvariabilitywithincreaseddoses.
§ NewformulationdevelopmentandadditionalclinicalstudieswillberequiredtomediatesafetyriskpriortofurtheroutpatientstudiesinAUDpatients.
§ Clinicaldevelopmentplansunderreview.
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SCHIZOPHRENIA:RBP-7000(PHASE III)
Clinical§ LongTermSafetytrial(RB-US-13-0005):OntrackwithLastPatientLastVisitexpectedby
Q4-2016.
Regulatory§ Pre-NDAMeetingwithFDA:HeldsuccessfullyinAugust2016.§ PlannedNDAsubmissionbyQ4-2017.
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2016PEER-REVIEWED SCIENTIFIC PUBLICATIONS:RBP-7000J.Clin.Psychopharmacology36(2):130-140.http://dx.doi.org/10.1097/JCP.0000000000000479
§ PhaseIIIefficacytrial(RB-US-09-0010):RBP-7000(90mg&120mg)significantlyreducedPositiveandNegativeSyndromeScale(PANSS)totalscores(primaryendpoint)andsignificantlyimprovedClinicalGlobalImpression– Severity(CGI-S)scores(secondaryendpoint)vs.placebo.BothRBP-7000dosageswerewelltolerated.
Schizophr.Res.174(1-3):126-131.http://dx.goi.org/10.1016/j.schres.2016.03.020
§ PhaseIIIefficacytrial(RB-US-09-0010):PatientsrandomizedtoRBP-7000(90mg&120mg)showedsignificantlygreaterimprovementsinHealth-RelatedQualityofLife(HRQoL)andoverallwell-beingvs.placebo.PatientsatisfactionandpatientpreferencefortheirmedicineimprovedsignificantlywithRBP-7000(90mgand120mg)vs.Placebo.
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INDIVIOR R&DDAY – DECEMBER 9TH,2016
§ NewYork– JefferiesOffices
§ InvitationstobesentoutinOctober
§ WeaimtolivewebcastforthosewhocannottraveltoNewYork.
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HalfYearFinancialResultstoJune30th,2016
FinancialBack-Up
P&LHalfYearEnded30th June:Unaudited
2015Reported
2015Adjusted
2016Reported
%change
2016Adjusted
%change
$mNetRevenues 517 517 531 +3 531 +3CostofSales (48) (48) (43) (43)Exceptionalitems - - (10)GrossProfit 469 469 478 +2 488 +4GrossMargin 91% 91% 90% 92%Selling,DistributionandAdministrationExpenses (180) (180) (217) +21 (217) +21Research&DevelopmentExpenses (54) (54) (59) +9 (59) +9Exceptionalitems (5) (4)ProfitonOrdinaryActivitiesbeforeinterest&taxation 230 235 198 -14 212 -10OperatingMargin 44% 45% 37% 40%EBITDA 242 247 210 -13 224 -9Netinterest (31) (31) (26) -16 (26) -16Taxation (55) (54) (51) +18 (51) -9- Exceptionaltaxitemwithintaxationlineabove (14)EffectiveTaxRate 28% 26% 38% 27%NetIncome 144 148 107 -26 135 -9
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Q1&Q2Trend– Adjusted(excludesexceptionals)(%Δ atconstantexchange:*numbersmaynotaggregateduetorounding)
$m Q1* % Δ Q2* % Δ HY % ΔNetRevenue 258 +4 274 +3 531 +3
GrossProfit(%margin) 237 (92%) 251 (92%) 488 (92%)
SD&A (105) (112) (217)
R&D (31) (28) (59)
ExceptionalCosts -
OperatingProfit 101 -12 111 -11 212 -11
OperatingMargin 39% 41% 40%
FinanceExpense (15) (11) (26)
Tax(%rate) (31) (36%) (20) (20%) (51) (27%)
NetIncome 55 -35 80 +18 135 -9
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$mHalfYear2015
HalfYear2016
%Change
%changeConstFX
USA 412 433 +5% +5%
Rest ofWorld 105 98 -7% -4%
Total 517 531 +3% +3%
NetRevenue– ByRegion
USA• Marketgrowthmid-to-highsingledigits• Sharegainfrom60%to61%• Priceincreaseoffsetbyannualisingofrebateincreasesfromlastyear.
RestofWorld• Europeangovernmentdrivenausteritymeasuresstillimpactingprice.
NetRevenue Commentary
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OperatingCostsH12016
OperatingExpenses
• SD&A increase driven by ongoing legal costs plus annualisedstandalone PLC costs (FY $55m).
• R&D increase with 2 products in Phase 3, but (with projectsterminated) full year will not see R&D increase at this %rate.
• Exceptional items cover one off legal & advisory costs forstrategic initiatives put in place to prepare againstpossibility of negative outcome in ANDA litigation
2015 2016 %ch
SD&A 180 217 +21
R&D 54 59 +9
Exceptionalitem 5 4 -
Depreciation&Amortisation(includedinSD&A)
12 12 -
Margins
H1 2015Adjusted
2016Adjusted
2016Reported
Grossmargin 91% 92% 90%
Operatingmargin 44% 40% 37%
• GrossMarginadjutedslightlyhigherduetosterlingweakeningagainstUSDandendingofmanufacturingroyaltiespaidtoMonosolRx.
• Exceptionalitemsof$10mforstrategicinitiativesrelatedtopotentialnegativeANDArulingincludedinCostofSales.
• Operatingmargin4%pointsdown
• Exceptionalcostreducedreportedmarginbyfurther3%
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Plusone-offexceptionaltaxchargeof$14m- $5minQ1
- $14minQ2less$5mtaximpactonexceptionalcostsinCostofSalesandSD&A
ReflectsmixofprofitsbetweenUKandUSA
TaxRate
Guidanceforrateof25%in2016
WorkingprogressivelytowardsthatguidanceQ1rate 36%Plus$5mexceptional
Q2rate 20%PlusNet$9mexceptional
HalfYearrate 27%
Continuetoguidetowardsfullyearrateof25%plusexceptionaltaxcharges
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CashflowsSixmonthsended30 thJuneUnaudited
$m 2015 2016CashFlowsfromOperatingActivities
OperatingProfit 230 198Reversalofnon-cashitems (4) 7Depreciationandamortisation 12 12Changesinassetsandliabilities 82 13CashgeneratedfromOperations 320 230Taxesandinterestpaid (100) (47)NetCashinflowfromOperatingActivities 220 183
CashFlowsfromInvestingActivities
Capex (8) (13)Purchaseofintangibleassets (4) -NetCashoutflowfromInvestingActivities (12) (13)
FreeCashFlow 208 170Netproceedsfromfinancingactivities (16) (60)
CashFlowsfromFinancingActivities
NettransferstoownersNetCashfromFinancingActivities (16) (60)Net(decrease)/increaseincashandcashequivalents 192 110Cashandcashequivalentsatbeginningofyear 331 467Cashandcashequivalentsatendofyear 523 577
37
CashConversionSixmonthsended30th June:
$m 2015 2016CashFlowsfromOperatingActivities
OperatingProfit 230 198Reversalofothernon-cashitems (4) 7Depreciationandamortisation 12 12Changesinassetsandliabilities 82 13CashgeneratedfromOperations 320 230Loanexpensesandtaxespaid (100) (47)Netcashinflowfromoperatingactivities 220 183NetCashFlowas%ofOperatingProfit 96% 92%
Cashconversioncontinuedstrong NetworkingcapitalreleaseofcashnotasstrongasFirstHalflastyearwhichbenefitedfromtimingofpayments.
38
BalanceSheet$m 2015
FullYear2016
HalfYearIntangibleAssets 62 49Othernon-currentAssets 154 153TotalNon-CurrentAssets 216 202CashandCashEquivalents 467 577Othercurrentassets 254 294TotalCurrentAssets 721 871TotalAssets 937 1,073Short-termBorrowings (34) (47)OtherCurrentLiabilities (569) (649)TotalCurrentLiabilities (603) (696)Borrowings(non-current) (571) (504)Provisionsforliabilitiesandcharges (42) (40)TotalNon-CurrentLiabilities (613) (544)TotalLiabilities (1,216) (1,240)
NetLiabilities (279) (167)
TotalEquity (279) (167)
Unaudited
39
Cash&BorrowingPositionatHalfYearFullYear2015
HalfYear2016
Cash&CashEquivalents 467 577
CurrentBorrowings (34) (47)
Long-termBorrowingsOther
(571)(36)
(504)(31)
NetDebt (174) (5)
• Secondinterimdividendtotalling$68mfor2015payableinJuly
NetDebtof$5mathalfyear,improvementof$169mintheperiodduetostrongcashin-flow.*
Afterrepurchaseofadditional$46mofdebtintheperiodinopenmarketatdiscount.
Retainingcashonbalancesheetatpresent
• Flexibilityonbusinessdevelopment
• Flexibilityoncorporatedebt/cashstructure
*Note6intheH12016FinancialResultsshowsnetdebtincludingdebtissuancecosts.
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StrengtheningourgloballeadershipinAddictionTreatment