ATEA - JPM Healthcare Conference Slide Deck _2025_FINAL.pdf

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1、ATEA CorporatePresentationJanuary 2025DISCLAIMERSForward-Looking Statements This presentation contains“forward-looking statements”within the meaning of the Private Securities Litigation Reform Act of 1995.Forward-looking statements are neither historical facts nor assurances of future performance.In

2、stead,they are based on our current beliefs,expectations and assumptions regarding the future of our business,future plans and strategies,our clinical results and other future conditions including without limitation the future of the HCV landscape and related commercial market opportunities.All stat

3、ements other than statements of historical facts contained in this presentation are forward-looking statements,including statements by Atea Pharmaceuticals,Inc.(the“Company”)regarding future results of operations and financial position,including our anticipated cash runway;business strategy;current

4、and prospective product candidates;anticipated milestone events;potential benefits of our product candidates and market opportunity;clinical trials,including,without limitation,anticipated initiation,enrollment,regulatory submission and data readout timelines;preclinical activities;product approvals

5、;manufacturing availability;degree of market acceptance of any products that may be approved;research and development costs;current and prospective collaborations;and prospects and opportunities for investors.In some cases,you can identify forward-looking statements by terms such as“may,”“will,”“sho

6、uld,”“expects,”“plans,”“anticipates,”“could,”“intends,”“targets,”“projects,”“contemplates,”“believes,”“estimates,”“predicts,”“potential”or“continue”or the negative of these terms or other similar expressions.The information in this presentation,including without limitation the forward-looking statem

7、ents contained herein,represent our views as of the date of this presentation.These statements are neither promises nor guarantees,but involve known and unknown risks,uncertainties and other important factors that may cause our actual results,performance or achievements to be materially different fr

8、om any anticipated results,performance or achievements expressed or implied by the forward-looking statements.Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug discovery and development process and the regulatory submission or appro

9、val process,unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts;delays in or disruptions to clinical trials or our business;our reliance on third parties over which we may not always have full control,our ability to manufacture sufficient

10、commercial product,competition from approved treatments for HCV,and other important risks and uncertainties that are described in our Annual Report on Form 10-K filed for the year ended December 31,2023 and our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commissi

11、on(“SEC”)and our other filings with the SEC.New risk factors and uncertainties may emerge from time to time,and it is not possible to predict all risk factors and uncertainties.Accordingly,you are cautioned not to place undue reliance on these forward-looking statements.Except as required by applica

12、ble law,we do not plan to publicly update or revise any forward-looking statements contained herein,whether as a result of any new information,future events,changed circumstances or otherwise.No representations or warranties(expressed or implied)are made about the accuracy of any such forward-lookin

13、g statements.Industry InformationMarket data and industry information used throughout this presentation are based on managements knowledge of the industry and the good faith estimates of management.We also relied,to the extent available,upon managements review of independent industry surveys and pub

14、lications and other publicly available information prepared by a number of third-party sources.All of the market data and industry information used in this presentation involves a number of assumptions and limitations,and you are cautioned not to give undue weight to such estimates.Although we belie

15、ve that these sources are reliable,we cannot guarantee the accuracy or completeness of this information,and we have not independently verified this information.While we believe the estimated market position,market opportunity and market size information included in this presentation are generally re

16、liable,such information,which is derived in part from managements estimates and beliefs,is inherently uncertain and imprecise.No representations or warranties are made by the Company or any of its affiliates as to the accuracy of any such statements or projections.Projections,assumptions and estimat

17、es of our future performance and the future performance of the industry in which we operate are necessarily subject to a high degree of uncertainty and risk due to a variety of factors,including those described above.These and other factors could cause results to differ materially from those express

18、ed in our estimates and beliefs and in the estimates prepared by independent parties.2Broad Antiviral Pipeline with De-risked Phase 3 Program3ProgramTherapeutic/IndicationPreclinicalPhase 1 Phase 2Phase 3Upcoming MilestoneFlaviviridaeHepatitis C Fixed Dose Combination:Bemnifosbuvir(BEM)Nucleotide+Ru

19、zasvir(RZR)NS5A InhibitorEnd-of-Phase 2 meeting with FDA planned for January 2025Phase 3 initiation planned for Q1 2025 RNA VirusesRespiratoryProtease InhibitorRNA VirusesOther RNA virusesNucleotideAT587,AT2490Cash,cash equivalents&marketable securities:$454.7 M at 12/31/24 Cash runway anticipated i

20、nto 2028BEM+RZR Regimen De-risked Phase 3 HCV Program for Multibillion-Dollar Market Robust Phase 2 results for antiviral therapies have historically led to high probability of success in Phase 3 studies High rate of regimen efficacy in the Phase 2 trial de-risks global Phase 3 programPotential Best

21、-In-Class TreatmentRobust Phase 2 ResultsReady for Commercial-scale ManufacturingLarge Market OpportunityLong Patent Life 4WHO Worldwide Numbers Global HCV:Large Market with Undertreatment of Infections -20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000 200,000201720182019202020212

22、022Newly Reported US HCV InfectionsNew Epclusa/Mavyret US Treated PatientsCDC US:2.4 4 Million Untreated,160K Newly Reported Annual Infections*Exceed Annual Cures3,41 WHO April 2024 2 www.cancer.gov/types/liver 3 CDC 2022 Viral Hepatitis Surveillance Report 4 IQVIA National Prescription Audit Decemb

23、er 2024*Newly reported chronic and acute HCV infections in US 5Number of US Patients50 Million People Infected11 Million New Infections Annually1 Chronic HCV is Leading Cause of Liver Cancer in US,EU&Japan2242,000Annual Deaths1US HCV:Major Commercial Opportunity Poised for Growth 6US Treatment202220

24、239 months 2024Total US HCV Market Net Revenues1$1.6B$1.5B$1.2BNet revenue per patient treated$17K$15K$17K1 Based on Global Net Revenues from Gilead and AbbVies year end 2022 and 2023 and nine months 2024 financial reports 2 Assumes treatment of 2.2 million chronically infected HCV patients at$10,00

25、0 net revenue per patient.Poised for GrowthOptimal product profile with potential to expand HCV treatmentRemoval of HCV prescribing barriers by payorsPotential US government initiatives to eradicate HCVAttractive Near-Term OpportunityPrimarily 2 product market Nocompetitors in clinical development$3

26、Bglobal net sales in 20231$1.5BUS net sales in 20231$20B+Potential US Market Opportunity294%of US Prescribers Want Improvements to Current HCV Therapies 38%29%26%6%53%51%25%0%Shorter Length ofTreatmentHigher TreatmentEfficacyFewerContraindications(e.g.,DDIs)No Unmet NeedsOverall1 Atea Custom Market

27、Research,IQVIA 2024 2 Atea Custom Market Research,PharmaValue Partners 2023HCV Prescribers and Patients Need Improved Therapy7Bemnifosbuvir(BEM)+Ruzasvir(RZR)best-in-class profile meets the need of HCV patients and prescribersBEM+RZR best-in-class profile more closely meets the needs of HCV patients

28、 and prescribersHCPs Report 20%of Patients Are Not Compliant with DAA Therapy1Co-Infected HIV/HCV PatientsUnmet Needs from Physician Survey(N=157 US Healthcare Providers)219%17%Estimated Percent NotCompleting DAA TreatmentEstimated Percent WhoMissed DosesDAA=Direct Acting Antiviral BEM+RZR:Potential

29、 Best-in-Class ProfileBEM+RZR:Next generation,pan-genotypic,fixed dose combination of BEM,most potent HCV nucleotide and RZR,highly potent HCV NS5A inhibitorTargeted Indications:Treatment of adult patients 18 years+with chronic HCV infection,with and without compensated cirrhosis Treatment DurationT

30、reatment DurationNon-Cirrhotic8 Weeks8 Weeks12 Weeks12 WeeksShort DurationProfile Patient PopulationMAVYRET8 Weeks12 WeeksBEM+RZREPCLUSAProtease-Inhibitor FreeNo Food EffectLow Potential for Drug-Drug InteractionsCompensated Cirrhosis(20 g-containing product 3 Cyclosporin 100 mg/d4 Digoxin 5 Omepraz

31、oleBEM+RZRPotential Best-in-ClassPan-Genotypic RegimenGlobal Phase 2 Results Global Phase 3 Program10Phase 2 Open Label Study of BEM+RZR in HCV Patients(N=275)11Per-ProtocolTreatment Adherent PopulationEfficacy Primary Endpoint(N=213)Per-Protocol Population Regardless of Adherence*(N=256)Total Enrol

32、led(N=275)17%of Patients Non-Adherent as Measured by Pill Count&PharmacokineticsPrimary Endpoints:SVR at Week 12 post-treatment(SVR12)in per-protocol treatment adherent populationSafetySecondary&Other Endpoints:SVR12 in per-protocol population regardless of treatment adherence(efficacy evaluable pop

33、ulation)Additional Data to Follow:SVR at Week 24 post-treatment(SVR24)Virologic failureResistancePatient Population:HCV-infected patients including compensated cirrhosis,direct-acting antiviral nave,all genotypesBEM 550 mg QDRZR 180 mg QD8 weeks dosing w/combinationEfficacy Primary Endpoint:High SVR

34、12 Rates with 98%SVR121298%95%0%20%40%60%80%100%OverallSVR12(%)208/213242/256Treatment adherent patients:98%SVR12(primary endpoint analysis)95%SVR12 Regardless of Adherence Robust potency and drug forgiveness Treatment viral kinetics in hard-to-treat cirrhotic patients Cirrhotic adherent patients:88

35、%SVR12 100%viral clearance at Week 8 in cirrhotic patients,should lead to very high SVR rates with a 12-Week treatment duration 85%100%0%20%40%60%80%100%Week 4Week 8HCV RNA one DAA on formulary Formulary inclusion assumes competitive contract pricing Ability to move market share and educate provider

36、s will be an important factorPayors covering 130M lives rated BEM+RZR profile either superior or comparable to Epclusa or Mavyret16%53%26%0%5%28%55%15%0%3%ExtremelywillingSomewhatwillingNeither willingor unwillingSomewhatunwillingExtremelyunwillingBy PayorBy LivesSource:Atea Custom Market Research,F

37、ormulary Insights 202418High willingness to add BEM+RZR regimen onto formulary By Lives By PayorBEM+RZR Regimen Has Potential to Become Most Prescribed Treatment in Multibillion-Dollar HCV Market3rd entrants with differentiated profile have been highly successfulTherapeutic Class3rd EntrantTime LagP

38、eak ShareGLP-1(Type 2 Diabetes,Pre-weight loss)OzempicLaunched in 2018,4 years after the 2nd product33%CGRP mAbs(Migraine)EmgalityLaunched in 2018,the same year as other products38%IL-5 antagonist mAbs(Asthma)FasenraLaunched in 2017,2 years after the first product41%52%30%48%29%41%CurrentPredictedPo

39、stBEM+RZRLaunch49%31%51%32%37%CurrentPredictedPostBEM+RZRLaunch46%30%54%36%34%CurrentPredictedPostBEM+RZRLaunchPWID2with or withoutcompensated cirrhosisNon-PWIDwith or withoutcompensated cirrhosisEPCLUSAMAVYRETBEM+RZRHIV Co-Infected1 Atea Custom Market Research,PharmaValue Partners 2023 2 IQVIA Nati

40、onal Prescription Audit 2024 3 LEK Consulting,First vs Best In Class19BEM+RZR Projected to be the Most Preferred DAA13rd Entrants in Highly Entrenched Class with Limited Competitors Have Captured 30%+Share2,3PWID=People Who Inject DrugsDe-risked Phase 3 Program with Blockbuster Potential 20BEM+RZR R

41、egimen De-Risked Phase 3 HCV Program for Multibillion-Dollar Market Potential best-in-class profile of regimen supports opportunity to disrupt global HCV market of approximately$3B in annual net salesPotential Best-In-Class TreatmentRobust Phase 2 ResultsReady for Commercial-scale ManufacturingLarge

42、 Market OpportunityLong Patent Life Demonstrated very high efficacy,low risk of DDIs,short treatment duration and no food effect 98%cure rate after short eight-week treatment duration for primary endpoint analysisFixed dose regimen tablet ready for Ph 3 Commercial-scale production ready$3B global net sales market with treatment expansion potential Atea IP for regimen until at least 20422122225 Franklin StreetSuite 2100Boston MA USA