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Coherus-JPM-20240110 .pdf

1、Denny Lanfear,Chief Executive OfficerJanuary 10,2024J.P.Morgan Annual Healthcare Conference 2024 Coherus BioSciences.Forward Looking StatementsForward Looking Statements-Except for the historical information discussed today and contained herein,the matters discussed today and set forth in this prese

2、ntation are forward-looking statements within the meaning of the“safe harbor”provisions of the Private Securities Litigation Reform Act of 1995,including,but not limited to,statements regarding partnerships and collaborations that may maximize value;expectations for the launch timing for UDENYCA OBI

3、;our expectations for share,opportunity,demand and payer coverage all increasing for UDENYCA;market opportunity projections for LOQTORZI;our ability to reach the full NPC patient population with LOQTORZI;our expectations about HCPs who represent potential targets for LOQTORZI promotion;our expectati

4、ons for the efficacy of casdozokitug or our other product candidates;our expectations that combinations with our internal pipeline and external collaborators will unlock value;expectations about the timing or ability to achieve future catalysts with our pipeline product candidates,including filing a

5、n IND for CHS-1000 and obtaining phase 1 data for CHS-114;and our ability to realize financial contributions and revenues from CIMERLI and YUSIMRY in 2024 and future years.Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus actual results,performance

6、or achievements to differ significantly from any future results,performance or achievements expressed or implied by the forward-looking statements.Such risks and uncertainties include,among others,the risks and uncertainties caused by our transition from a biosimilar focused company to an innovative

7、 immuno-oncology franchise funded by sales from FDA-approved therapeutics;the risks and uncertainties inherent with clinical research and commercialization;the risks and uncertainties of the clinical development and regulatory approval process,including(but not limited to)the timing of Coherus regul

8、atory filings;the risk that Coherus is unable to complete commercial transactions;risks and uncertainties in executing collaboration agreements and other joint ventures,including particular risks of working with international partners;and the risks and uncertainties of litigation.All forward-looking

9、 statements contained in this press release speak only as of the date on which they were made.Coherus undertakes no obligation to update or revise any forward-looking statements.For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in

10、 these forward-looking statements,as well as risks relating to Coherus business in general,see Coherus Quarterly Report on Form 10-Q for the fiscal quarter ended September 30,2023,filed with the Securities and Exchange Commission on November 6,2023,including the section therein captioned“Risk Factor

11、s,”and in other documents Coherus files with the Securities and Exchange Commission.UDENYCA,YUSIMRY,CIMERLI and LOQTORZI,whether or not appearing in large print or with the trademark symbol,are trademarks of Coherus,its affiliates,related companies or its licensors or joint venture partners,unless o

12、therwise noted.Trademarks and trade names of other companies appearing in this presentation are,to the knowledge of Coherus,the property of their respective owners.2AgendaCompany SummaryCore Oncology Business R&D OutlookNon-Core ProductsConcluding Remarks 2024 Coherus BioSciences.A Revenue Stage Ful

13、ly Integrated Oncology Company A Robust Portfolio of Oncology ProductsCombinations with LOQTORZI to Enhance Antitumor Immune Response4PreClinicalPhase 1Phase 2Pivotal Clinical TrialsApprovalLOQTORZIPD-1CasdozokitugIL-27CHS-114CCR8CHS-1000ILT4 2024 Coherus BioSciences.Delivering on Long Term Strategy

14、Launch Products,Grow Revenues,Manage Spend5 FDA Approvals4 Product LaunchesUDENYCA OBI approval Q4 2023LOQTORZI approval and launchUDENYCA Autoinjector approval and launchCIMERLI approval and launchYUSIMRY approval and launchaRevenue Growth from Commercial PortfolioStrengthening Balance Sheet Portfo

15、lio prioritization to optimize R&D spend SG&A tight expense management Align capital structure with strategy Pursuing partnerships and collaborations to maximize value5Non-CoreProven ExecutionLong Term Revenue DriversFinancial Discipline 2024 Coherus BioSciences.2023 Revenue GrowthQuarter over quart

16、er sales growth from Q1 through Q462023 Net Revenues($255-$260 million)achieved upper end of guidance rangeQ4 revenues$90MCIMERLI Quarter-over-quarter revenue growth after Q-Code April 2023UDENYCA Quarter-over-quarter net revenue growth Strong ASP to support Q1 2024 OBI launchThree presentations pro

17、vide long term market share increase opportunityLOQTORZI Distributors stocked,patients dosed,sales ramp initiatedThe preliminary 2023 financial information presented here has not been reviewed by our auditor or audited and is subject to significant change.We have not completed our financial close pr

18、ocess.The completed,audited Coherus Fourth Quarter and Full Year 2023 Financial Results are planned for release in March 2024AgendaCompany SummaryCore Oncology Business R&D OutlookNon-Core ProductsConcluding Remarks 2024 Coherus BioSciences.Translucent window with solid black fill indicator against

19、a white backgroundHigh-quality,well-tolerated adhesive1Status light indicates if device is working properlyUDENYCA ONBODY Injector Approved December 2023Proprietary State-of-the Art DeliveryPatient and Physician Informed R&D Bring Forward a Novel and Proprietary InjectorInnovative and Differentiatin

20、g Device FeaturesAttributeUDENYCA ONBODY2,3Injection Time5 minutesInjection modalityNeedle inserted at time of injection and remains inserted for only 5 minutesNeedle retractionAutomatic retraction of needle after deliveryFill indicatorBlack indicator moves against a white backgroundAdhesiveLarge su

21、rface area with well-tolerated adhesive1References:1.Data on file.Coherus BioSciences,Inc.;2023.2.UDENYCA ONBODY HCP Instructions for Use.3.UDENYCA Prescribing Information.Metal medicine port and green fill guide support proper filling8 2024 Coherus BioSciences.Total Solution Reaches More Patients,D

22、rives Long Term Share GrowthComprehensive Franchise Built for Profitable GrowthInnovation Provides the Total SolutionPrefilled Syringe PatientPrefers next day visit with oncologistsLikes the confidence ofin-office administrationAutoinjector PatientDesires control over injection processComfortable wi

23、th self-injectionsOn-Body Injector PatientUnable to come back to the office next dayPrefer“set it and forget it”9The Only Pegfilgrastim Brand with Three Presentation Options 2024 Coherus BioSciences.10UDENYCA Core Business Is Strong and GrowingExecuting a Strategy to Maximize Revenue and Profitabili

24、ty Base Business PFS Share 17%,+6 share points gained in 2023 OBI Approval&launch unlocks significant opportunity Autoinjector demand increasing Payer coverage nearly doubles vs.20232023:Delivered the Growth Source:IQVIA National Sales Perspective;4Q23 R4W from week ending 12/1/23 to 12/22/2311.5%12

25、.2%16.5%17.3%1Q232Q233Q23R4W 4Q23UDENYCA Market Share2024:Continued Growth Drivers 2024 Coherus BioSciences.LOQTORZI:Establishing a New Standard of Care as the First and Only FDA-Approved Treatment for Nasopharyngeal Carcinoma(NPC)in All Lines of TherapyLeveraging existing commercial oncology footpr

26、int to reach the full NPC patient population in the U.S.Only Preferred NCCN regimen in 2nd Line treatment and laterStrongly supportive patient and physician community11Only I-O treatment with Preferred Category 1 designation under NCCNin combination with gemcitabine and cisplatin“LOQTORZI is a new t

27、reatment option that has demonstrated the ability to significantly improve PFS and OS and should quickly emerge as the new standard of care when used in combination with chemotherapy.”2,000 NPC treated patients Estimated annual U.S.patient populationJong Chul Park,M.D.Assistant Professor,Harvard Med

28、ical School and attending physician at the Center for Head and Neck Cancers at Massachusetts General Hospital Cancer Center$200M Market Opportunity 2024 Coherus BioSciences.Focused on Driving Rapid LOQTORZI Adoption Identifying Patients and Targeting Healthcare Providers120%10%20%30%40%50%60%70%80%9

29、0%100%0%20%40%60%80%100%of Tori Value%of HCPs treating NPC and HNC2.2K HCPs Represents 80%of the LOQTORZI PotentialClaims Source:IQVIA Claims data through 4/22/2023,R1Y totalsNPC Value weightings*Examples of several tools being implementedEarly Adopter(30%)Non-early Adopter(20%)Chemo User(50%)PD-1 U

30、ser(50%)34%Of The NPC Treating Physicians Are In California,Texas,Florida and New YorkIQVIA NPC Predictive Alerts EHR InstructionToolTargeted HCP PromotionHCP SegmentationTools to Identify Patients*2024 Coherus BioSciences.Engaging and Educating the NPC Patient Community2,100 NPC Patients&Caregivers

31、 Enrolled in our Community13Branded Patient CampaignPrimes With NPC Disease State EducationSteady Cadence of Branded Information to Request by NameCampaign Education FlowAgendaCompany SummaryCore Oncology Business R&D OutlookNon-Core ProductsConcluding Remarks 2024 Coherus BioSciences.LOQTORZI Combi

32、nations with Tumor Microenvironment Agents Aim to Extend Cancer Patients SurvivalFirst-in-Class and Competitively Positioned Assets with Supporting Clinical DataSource:“Immune Checkpoint Blockade in Cancer Therapy”;Allison,James;Nobel Lecture(December 2018)Standard/Other TherapyIO(anti-CTLA4,PD-(L)1

33、)ControlIO CombinationsPotential Improvement from CombinationsTime%SurvivalExtending SurvivalCoherus I-O Pipeline:Tumor Microenvironment focusPreClinicalPhase 1Phase 2Pivotal Clinical TrialsFDA ApprovedLOQTORZIPD-1CasdozokitugIL-27CHS-114CCR8CHS-1000ILT4 2024 Coherus BioSciences.PD-1 Inhibitor+TME T

34、argeting Agents to Overcome PD-1 ResistanceRelieving T/NK cell exhaustion(toripalimab-tpzi;casdozokitug)Targeting/reprogramming major resistance mechanisms(casdozokitug,CHS-114,CHS-1000)CHS-1000ILT-4TAMIL-27Anti-ILT4LOQTORZIT CellPD-1Anti-PD-116FDA approvedlabel expansion through combinationsCasdozo

35、IL-27tolDCILT-4Anti-IL-27First and only clinical stagePromising approach for overcoming PD-1 resistanceCHS-114CCR8itTregAnti-CCR8TregHighly selective and potentImmune Suppressive TME 2024 Coherus BioSciences.17IL-27IL-27 upregulates checkpoint receptors Percentage positive CD8+T Cells+IL-27 ControlC

36、hihara et al,Nature 558,2018DeLong et al,Immunohorizons 3,2019IL-27 downregulates pro-inflammatory cytokinesT N F p g/m L+IL-27 ControlChihara et al,Nature 558,2018DeLong et al,Immunohorizons 3,2019Aghayev et al,Cancer Discov,12,2022IL-27 constrains NK cell immunosurveillancePD-L1Lag3TigitTim3IL-27R

37、Pro-inflammatory cytokinesIL-27 ra+/-IL-27ra-/-MyeloidDCIL-27T cellT cellNK cellNK cellT cellIL-27 Mechanism of Tumor Immune Suppression 2024 Coherus BioSciences.Casdozokitug Monotherapy in Non-Small Cell Lung Cancer(NSCLC)Best Percent Change from Baseline in Sum of Target Lesions(n=38)Data cut as o

38、f 21 Sept 2023,subject to changeCasdozokitug has Demonstrated Monotherapy Activity in Lung Cancer 18Marron,T.,et al.,2023 ESMO Immuno-Oncology Congress,Poster#122P2 confirmed PRs in PD-L1 negative or low,squamous NSCLC and 1 durable disease stabilization in adenocarcinoma;all 3 previously treated wi

39、th PD-(L)1 antibodies22%ORR in squamous subset(n=2/9)Clinical demonstration of PoM immune activation in cancer patientsPhase 1b/2 combination trial with LOQTORZI,which has proven NSCLC efficacy,is progressing 2024 Coherus BioSciences.840------103-002

40、410------------------102-001-100-80-60-40-200204060(%)Change from BaselineHBV HCV No Viral Disease Partial Response Stable Disease

41、 Progressive DiseaseCasdozo Combination Activity in First-Line Liver CancerEarly and Encouraging Data19Data cut as of 14 Apr 2023,subject to changeCasdozokitug/Atezolizumab/Bevacizumab in Hepatocellular Carcinoma(HCC)Best Percent Change from Baseline in Sum of Target Lesions(n=24)Early data snapshot

42、,with 50%of patients with 1 on-study imaging assessment(30 patients treated)27%ORR to date in response evaluable setUnique first line liver cancer opportunities with toripalimab More mature data set being presented at 2024 ASCO GI Next Week!2024 Coherus BioSciences.Combinations with Internal Pipelin

43、e and External Collaborators Will Unlock Value and Expand Indications20TME Focused I-O PipelineOther External Trialswith ADCs,TCEs etc.InvestigatorSponsored TrialsPhase 3 StudyJunshi Pipeline 2024 Coherus BioSciences.Combined I-O Pipeline with 2024 CatalystsAgentTargetProposed IndicationPreclinicalP

44、hase 1Phase 2Pivotal Clinical TrialsApprovalNear-Term CatalystsLOQTORZIPD-1Nasopharyngeal Carcinoma(1L combo with chemo)Nasopharyngeal Carcinoma(2L/3L monotherapy)U.S.Launch in NPC:External Research Collaborations Q1 2024CasdozokitugIL-27Hepatocellular CarcinomaNon-Small Cell Lung CancerHCC Triplet

45、Combo Data Q1 24NSCLC Monotherapy Data Q4 23-ongoingCHS-114CCR8Solid Tumors including Head&Neck CancerCHS-114 Phase 1 Data H1 24CHS-1000ILT4Solid Tumors(in combination with toripalimab)IND Filing H1 24Innovative Immuno-Oncology Pipeline21TIGIT asset discontinuedAgendaCompany SummaryCore Oncology Bus

46、iness R&D OutlookNon-Core ProductsConcluding Remarks 2024 Coherus BioSciences.CIMERLI and YUSIMRYNon-Core Products Provide Additional Value Contribution in 2024$125M Cumulative Annual Net Revenue thru Q4 2023129%market share in Q3 among ranibizumab class;38%R4W share thru 12/22/232190,000 Doses Ship

47、ped Since Launch3Efficacy and safety profile delivering on its promiseInnovators of Low WAC StrategyLaunched at 85%discount to branded HUMIRA&positions for IRA implementation in 25 Partnership with Mark Cuban Cost Plus Drug CompanyServing customers and patients desiring affordable,transparent price

48、for adalimumab231.The preliminary 2023 financial information presented here has not been reviewed by our auditor or audited and is subject to significant change.We have not completed our financial close process.The completed,audited Coherus Fourth Quarter and Full Year 2023 Financial Results are pla

49、nned for release in March 2024;2.IQVIA WSP&NSP Q1-Q3 3023;3.Coherus demand data through Dec 29,2023AgendaCompany SummaryCore Oncology Business R&D OutlookNon-Core ProductsConcluding Remarks 2024 Coherus BioSciences.Delivering on Long Term StrategyLaunch Products,Grow Revenues,Manage Spend5 FDA Appro

50、vals4 Product LaunchesUDENYCA OBI approval Q4 2023LOQTORZI approval and launchUDENYCA Autoinjector approval and launchCIMERLI approval and launchYUSIMRY approval and launchaRevenue Growth from Commercial PortfolioStrengthening Balance Sheet Portfolio prioritization to optimize R&D spend SG&A tight expense management Align capital structure with strategy Pursuing partnerships and collaborations to maximize value25Non-CoreProven ExecutionLong Term Revenue DriversFinancial DThank You

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