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1、1Near-Term Launches High-Value Pipeline DayDecember 12,2022Christopher Stevo Senior Vice President,Chief Investor Relations Officer2Near-Term Launches High-Value Pipeline Day|Forward-Looking Statements,Non-GAAP Financial Information and Other NoticesFLSFLS Our discussions during Near-Term Launches+H
2、igh-Value Pipeline Day includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.We include forward-looking statements about,among other topics,our anticipated op
3、erating and financial performance;reorganizations;business plans,strategy and prospects;expectations for our product pipeline,in-line products and product candidates,including anticipated regulatory submissions,data read-outs,study starts,approvals,launches,clinical trial results and other developin
4、g data,revenue contribution and projections,pricing and reimbursement,potential market dynamics and size,growth,performance,timing of exclusivity and potential benefits;strategic reviews,capital allocation objectives,dividends and share repurchases;plans for and prospects of our acquisitions,disposi
5、tions and other business development activities;our ability to successfully capitalize on growth opportunities and prospects;manufacturing and product supply;our efforts to respond to COVID-19,including our COVID-19 products;our expectations regarding the impact of COVID-19 on our business,operation
6、s and financial results;and other statements about our business,operations and financial results.Among other things,statements regarding revenue and earnings per share growth;the development or commercial potential of our product pipeline,in-line products,product candidates and additional indication
7、s or combinations,including expected clinical trial protocols,the timing of the initiation and progress of clinical trials and data read-outs from trials;the timing for the submission of applications for and receipt of regulatory approvals;the timing of product launches;expected profile and labeling
8、;potential revenue;expected breakthrough,best or first-in-class or blockbuster status or expected market entry of our medicines or vaccines;the regulatory landscape;and the competitive landscape are forward-looking and are estimates that are subject to change and subject to clinical trial and regula
9、tory success,availability of supply,competitive and market dynamics and other risks,assumptions and uncertainties.These statements may be affected by underlying assumptions that may prove inaccurate or incomplete,and are subject to unknown risks,uncertainties and other factors that may cause actual
10、results to differ materially from past results,future plans and projected future results.As forward-looking statements involve significant risks and uncertainties,caution should be exercised against placing undue reliance on such statements.Additional information regarding these and other factors ca
11、n be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31,2021 and its subsequent reports on Form 10-Q,including in the sections thereof captioned“Risk Factors”and“Forward-Looking Information and Factors That May Affect Future Results”,as well as in our subsequent report
12、s on Form 8-K,all of which are filed with the U.S.Securities and Exchange Commission and available at www.sec.gov and .Potential risks and uncertainties also include global economic and/or geopolitical instability,foreign exchange rate fluctuations and inflationary pressures and the impact of COVID-
13、19 on our sales and operations,including impacts on employees,manufacturing,supply chain,marketing,research and development and clinical trials.The forward-looking statements in this presentation speak only as of the original date of this presentation and we undertake no obligation to update or revi
14、se any of these statements.Also,the discussions during Near-Term Launches+High-Value Pipeline Day may include certain financial measures that were not prepared in accordance with U.S.generally accepted accounting principles(GAAP).Additional information regarding non-U.S.GAAP financial measures can b
15、e found in Pfizers Quarterly Report on Form 10-Q for quarterly period ending October 2,2022 filed with the SEC on November 9,2022.Any non-U.S.GAAP financial measures presented are not,and should not be viewed as,substitutes for financial measures required by U.S.GAAP,have no standardized meaning pre
16、scribed by U.S.GAAP and may not be comparable to the calculation of similar measures of other companies.Todays discussions and presentation are intended for the investor community only;they are not intended to promote the products referenced herein or otherwise influence healthcare prescribing decis
17、ions.Definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data as they may be confounded by various factors and should be interpreted with caution.All trademarks in this presentation are the property of their respective owners.Paxlovid and emergency uses of the Pfizer-B
18、ioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5),have not been approved or licensed by the FDA.Paxlovid has not been approved,but has been authorized for emergency use by the U.S.Food and Drug Administration(FDA)under an Emergency Use Authoriz
19、ation(EUA),for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients(12 years of age and older weighing at least 40 kg 88 lbs)with positive results of direct SARS-CoV-2 viral testing,and who are at high-risk for progression to severe COVID-19,including hospitalization or death.
20、Emergency uses of the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19,Bivalent have been authorized by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months and older.The emergency uses are only authorized for the duration of the declaration that circumstances exist
21、 justifying the authorization of emergency use of the medical product during the COVID-19 pandemic under Section 564(b)(1)of the FFDCA unless the declaration is terminated or authorization revoked sooner.Please see the EUA Fact Sheets at and www.cvdvaccine-.3Near-Term Launches High-Value Pipeline Da
22、y|AGENDAAgendaAgenda6pm-7pm Reception/Passed Hors dOeuvresSession 1 Key Near-Term Launches(1-3:30pm)Welcome Chris StevoOpening Remarks Angela HwangPotential Product Launches Presentations:Nurtec/Vydura Rodrigo Puga RSV Vaccines Sinan Atlig Etrasimod Kevin Sullivan Ritlecitinib Kevin Sullivan Elranat
23、amab Suneet Varma Talzenna Prostate Suneet VarmaQ&ABreak 3:30-4pmSession 2 High-Value Pipeline(4-6pm)Pipeline Presentations:Anti-IFN-Mike Corbo and Andy Schmeltz Danuglipron&PF-1532 Jim Rusnak and Andy Schmeltz TTI-622 Chris Boshoff and Andy Schmeltz Inclacumab&GBT-601 Chris Boshoff and Andy Schmelt
24、z mRNA Vaccines Flu,VZV,Flu/COVID Combo Annaliesa Anderson&Navin KatyalQ&AClosing Remarks David Denton4Angela HwangChief Commercial OfficerPresident,Global Biopharmaceuticals BusinessBreakthroughs that change patients lives Near-Term Launches High-Value Pipeline DayDecember 12,20225Near-Term Launche
25、s High-Value Pipeline Day|*For illustration purposes only and not intended to be to scale.All values at constant exchange rates.1Excludes 2022-2025 BD and 2022+Launches2Midpoint of expected negative LOE impact of$16B-$18B from 2025-2030.3Risk-adjusted 2030 revenue goal from recent and new BD deals4I
26、nternal 2030 risk-adjusted revenue expectations for NME and new indications launches as shown in slide 3Note:Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply.Fortifying our Long-Te
27、rm Growth PlansIntroductionIntroductionIllustrative*2025-2030 ProjectionsAt least$25B3$20B4$17B22025 BaselineRevenues12025-2030LOEsNew BD Deal 2030Risk-Adjusted Revenues2022 YTD&Next 18 Months Launches 2030 RevenuesAdditional Internal Pipeline Revenue through 20302030 Revenues6Near-Term Launches Hig
28、h-Value Pipeline Day|New Launches/Co-promotions and Potential Product Launches1Product CandidateAnticipated IndicationExpected LaunchNew Molecular Entity(NME)LaunchesNgenla(Ex-US)Growth Hormone Deficiency2022RitlecitinibAlopecia Areata2023ElranatamabTriple Class Relapsed or Refractory(Resistant to i
29、mmunomodulators,proteasome inhibitors,and anti-CD38 therapy)Multiple Myeloma2023RSV Adults(60+)Prevention of RSV-associated LRTI in adults 60 years2023*RSV MaternalPrevention of RSV-associated LRTI in infants(via maternal immunization)2023*Pentavalent Meningococcal VaccinePrevention of meningococcal
30、 infection by serogroups ABCWY2023*AbriladaAdalimumab Biosimilar2023mRNA flu VaccineInfluenza2024*New IndicationsMyfembreeEndometriosisAugust 2022(Pfizer co-promote)COVID-19 vaccine BA.4/BA.5 variantCOVID-19September 2022CibinqoAtopic Dermatitis Adolescent2023Braktovi/MektoviLung Cancer(PHAROS)2023T
31、alzenna(Talazoparib)+Xtandi(enzalutamide)Metastatic castration resistant prostrate cancer(TALAPRO2)2023XtandinmCSPC(EMBARK)2023Prevnar 20 PedsPrevention of invasive pneumococcal disease,otitis media-Pediatric2023*Recently Announced Business Development DealsNurtec ODT/VyduraAcute treatment and episo
32、dic prevention of MigraineAugust 2022(Pfizer promotion)2Zavegepant(intranasal)Acute Treatment of Migraine2023OxbrytaSickle cell diseaseOctober 2022(with merger close)EtrasimodUlcerative Colitis2023IntroductionIntroductionNote:Expected timing;all dates are preliminary,subject to change,and subject to
33、 clinical trial and regulatory success and availability of supply*Estimated FDA decision;subject to regulatory approval,ACIP and MMWR to follow1 Over the next 18 months,we expect to have up to 19 new products or indications in the market including the five for which we have already begun co-promotio
34、n or commercialization earlier this year2Through a standalone detailing arrangement7Near-Term Launches High-Value Pipeline Day|Data&Analytics Designed to Deliver a Superior Omnichannel Customer ExperienceIntroductionIntroductionOur customers expect a seamless experience that is more personalized,sci
35、entifically robust,and efficient in addressing patient needs.Human center,tailored experiences based on customer needs and preferences by leveraging advanced data&analytics.A Personalized ExperienceMeet customers where and how they want,with relevant information using expanded channels and high digi
36、tal tech.High Tech Relevant EngagementsSeamless access to subject matter expertise who can providehigh-quality information to enable critical decisions for patients.An Expert Resource8Near-Term Launches High-Value Pipeline Day|Evolving an Enhanced Customer Experience at Speed and ScaleIntroductionIn
37、troductionMarkets now live with the new organizational model including U.S.,UK and EU4(Germany,France,Italy,and Spain).All markets(78)including China and Japan by January 1,2023.Redefined Our Go-To-Market Model to Transform How We Engage with HCPs and Patients68New Data Scientists and a new Applied
38、Intelligence and Insights organization.80+Customer Facing roles globally,equipped with hybrid customer engagement technologies.16,000+New Subject Matter expert roles including medical,access and commercial.2,500+9Near-Term Launches High-Value Pipeline Day|3 Global Customer-Focused OrganizationsDrivi
39、ng Commercial Excellence Biopharmas Operating Model EvolutionIntroductionIntroductionGlobalPrimary Care(COVID,Vaccines,Internal Medicine)Angela Lukin Business President Streamlined in-country structure with geographical focus Greater connectivity between global strategy and local execution Embedded
40、Marketing,Medical,and Access capabilities Prioritized markets and brands with the greatest impact with specific focus on launchesGlobalSpecialty Care(Rare Disease,I&I,Hospital)Kevin Sullivan Business PresidentGlobalOncologySuneet Varma Business President10Near-Term Launches High-Value Pipeline Day|R
41、esources,Capabilities&Track Record of LeadershipCommercial and Manufacturing LeadershipPfizers US field force ranked#1 in the Industry for the fourth year in a row in the 2022 Sales Force IQVIA Rankings.The Pfizer Field team has also moved to#1 with several key customer segments:Cardiologists,Nurse
42、Practitioners,OB/GYNs and Urologists1Pfizer Hospital Sterile Injectables and Surgical sales teams voted#1 for Best Customer Facing Colleague2 for the third consecutive yearPfizer Oncology ranked#1 overall in Market Engagement with Key Accounts3Best in Industry customer service levels and awarded 202
43、2 Gartner Supply Chain Award for Patient Innovation4Ranked#6 in Gartners Supply Chain Top 25 list for 2022 for transforming global supply chain from cost driver to competitive advantage51.This information is an estimate derived from the use of information under license from the following IQVIA infor
44、mation service:Sales Force Structures and Strategies for the period 2021-2022.(ref.:table 1-page 5 and paragraph 1-page 7).IQVIA expressly reserves all rights,including rights of copying,distribution and republication.2.2021 ZS Hospital Customer Survey(double blinded)3.Health Industries Research Cen
45、ter,April 2022 report:Academic Institution&Health System-Based Cancer Centers:Market Trends&Manufacturer Competitive Assessment 4.https:/ 5.https:/ 6.Morning Consult survey:Brand Familiarity:Pharmaceutical BrandsPfizer ranked#1 for the first time ever in the 2021 Patient View Global Survey Pfizer wa
46、s recognized as one of the Worlds Most Ethical Companies by EthispherePfizer ranked#4 on Fortunes annual Worlds Most Admired Companies list the highest ranking we have ever achievedPfizers brand awareness stands at an impressive 82%;61%of the general population views Pfizer favorably(compared with 4
47、2%for the industry as a whole)Industry LeadershipIntroductionIntroduction11Near-Term Launches High-Value Pipeline Day|New Launches/Co-promotions and Potential Product Launches1IntroductionIntroduction1Over the next 18 months,we expect to have up to 19 new products or indications in the market includ
48、ing the five for which we have already begun co-promotion or commercialization earlier this year.Note:Expected timing;all dates are preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial and regulatory success and availability of supply.2022Nurtec
49、 ODT/Vydura2023RSV Adults(60+)RSV MaternalPrimary Care2023RitlecitinibEtrasimodSpecialty Care2023ElranatamabTalzenna(Talazoparib)+Xtandi(enzalutamide)Oncology12NurtecODT/Vyduraand zavegepant(BHV-3500)Potential Breakthrough Therapies for Patients with MigraineRodrigo PugaUS Commercial&Global Business
50、 Lead Internal MedicineDecember 12,202213Near-Term Launches High-Value Pipeline Day|Migraine is a Debilitating Disease Impacting Over 1B Patients WorldwideSources:1.Ashina M,Katsarava Z,Do TP,et al.Migraine:epidemiology and systems of care.Lancet.2021;397:1485-95.2.Ashina M.Migraine.N Engl J Med.202
51、0;383(19):1866-76.3.Ailani J,et al.,Headache.2021 Jul;61(7):1021-1039.Disease Overview&Demographics:MigraineMigraineMigraine Disease Overview&Demographics3-fold higher prevalence in women,compared to men,and peaks at age 35-39 years1Migraine is a common neurological disease affecting 1 billion peopl
52、e worldwide.One year prevalence estimated at 15%of the general population1Migraine is a life disrupting disease and has a negative impact ranging from lost productivity at work to repercussions on relationships and parenting1Migraine may be treated acutely to abort an attack,or preventively to reduc
53、e the frequency and severity of attacks3Significant health economic burden,estimated 50-111 Billion in EU for 2011,the majority of which are indirect costs related to productivity losses214Near-Term Launches High-Value Pipeline Day|14 Days94%15+Days6%Episodic MigraineChronic MigraineHeadache Days Pe
54、rMonth1,2,3%of Patients3Acute TreatmentType of Migraine1,2Preventive TreatmentTreatment Approach2,4Source:1.https:/www.ichd-3.org/1-migraine/.2.Ailani J,et al.,Headache.2021 Jul;61(7):1021-1039.3.Blumenfeld AM et al.Cephalalgia.2011;31(3):301-315.4.Ha H,Gonzalez A.et al.,Am Fam Physician.2019 Jan 1;
55、99(1):17-24.Note:Nurtec is approved for the acute treatment of migraine in adults(18+)and the preventive treatment of episodic migraine in adults(18+)Understanding Migraine Disease&Treatment ApproachesMigraineMigraine Disease&Treatment Approaches15Near-Term Launches High-Value Pipeline Day|Migraine
56、Unmet Needs Span both Acute and Preventive TreatmentPatients With Migraine Have Struggled With The Limitations of Migraine treatments MigraineMigraine Unmet NeedCardiovascular Disease ContraindicationMedication Overuse HeadachePotential Limitations:Acute Treatment15Potential Limitations:Preventive C
57、are612Tolerability IssuesDelayed EfficacyTolerability IssuesHigh Discontinuation Rates1.Derry C,et al.Cochrane Database Syst Rev 2012;2012:CD008615;2.Cameron C,et al.Headache 2015;55(suppl 4):221235;3.Schwedt T,et al.J Headache Pain 2018;19:38;4.Rosen N,Duarte R.Pract Neurol(Fort Wash PA)May 2021.Av
58、ailable at:https:/ 5.Buse D,et al.Headache 2017;57:3144.6.Silberstein S et al.Supplemental E-Tables.Neurology 2012;78:13371345;7.Silberstein S et al.Neurology 2012;78:1337-1345;8.Amitriptyline hydrochloride.Package insert.Sandoz Inc.;9.Topamax.Package insert.Janssen Ortho LLC.Available at:TOPAMAX-pi
59、.pdf()(Last accessed May 2022);10.Divalproex sodium.Package insert.Abbott Laboratories;11.Hepp Z et al.Cephalalgia 2017;37:470 485;12.Hubig LT et al 2022 Headache.Need for Rescue MedicationRoute of Administration16Near-Term Launches High-Value Pipeline Day|Acute Treatment Nurtec/VyduraPreventive Tre
60、atment Nurtec/VyduraLow Need for Rescue Medication86%of patients had no need for rescue medication1Oral Versus InjectablePatients starting anti-CGRP therapy have expressed a preference for oral therapy versus injectable3Low Risk of Medication Overuse HeadacheCGRP mechanism is not associated with MOH
61、2Early Onset EfficacyData*suggest preventative effect after 1 week of treatment4Not CV ContraindicatedNo CV contraindication2Discontinuation RatesAEs led to discontinuation in 2.8%of patients5TolerabilityMost common AEs include nausea(2.0%)vs.placebo(0.4%)2TolerabilityMost common AEs include nausea(
62、2.7%)and abdominal pain/dyspepsia(2.4%)vs placebo(0.8%and 0.8%)2MOH:Medication Overuse Headache,USPI:United States Prescribing Information,AEs:Adverse Events1.Croop R,et al.Lancet.2019;394(10200):737-745.2.Nurtec USPI 3.Hubig LT et al.,Headache.2022 Oct;62(9):1187-1197 4.Lipton R,et al.Poster presen
63、ted at:AHS 2021 Virtual Annual Scientific Meeting(63rd);June 3-6,2021.5.Lipton RB et al.Oral Presentation at:American Headache Society 64th Annual Scientific Meeting;June 9-12,2022,Denver,CO,USA*Exploratory analysis of Ph3 prevention study,which met its primary endpoint of reduction in Monthly Migra
64、ine Days during weeks 9-12 vs.placeboMigraineMigraine Nurtec&Unmet NeedNurtecODT/VyduraCan Help Address Many Unmet Needs Associated with Acute and Preventive Therapy17Near-Term Launches High-Value Pipeline Day|ACUTE TreatmentPREVENTIVETreatmenttriptansubrogepantlasmiditanSOC*incl.topiramategalcanezu
65、mabatogepanterenumabfremanezumabNurtecODT/VyduraChanges the Treatment ParadigmSource:Reyvow USPI,Ubrelvy USPI,Nurtec USPI,Eigenbrodt AK et al,Nature Reviews Neurology,2021;17:501-14,Ailani J et al,Headache.2021;61:10211039.Source:Vyepti USPI,Ajovy USPI,Emgality USPI,Aimovig USPI,Quilipta USPI,Nurtec
66、 USPI,Eigenbrodt AK et al,Nature Reviews Neurology,2021;17:501-14,Ailani J et al,Headache.2021;61:10211039.*Common standard of care,oral preventative medications may include propranolol or metoprolol,topiramate,flunarizine,valproate,amitriptyline,venlafaxine,lisinopril,and candesartan18Near-Term Lau
67、nches High-Value Pipeline Day|Achieved Pain Freedom Within 2 Hours2Commercial Strategy1.VYDURA(rimegepant)package insert and NURTEC(rimegepant)package insert Dublin,Ireland:Pfizer Incorporated/Biohaven Pharmaceutical Holding;Company Ltd;2022;2.Croop R,Goadsby PJ,Stock DA,et al.Efficacy,safety,and to
68、lerability of rimegepant orally disintegrating tablet for;the acute treatment of migraine:a randomised,phase 3,double-blind,placebo-controlled trial.Lancet.2019;394;(10200):737-745.;3.Croop R,Lipton RB,Kudrow D,et al.Oral rimegepant for preventive treatment of migraine:a phase 2/3,randomised,double-
69、blind,placebo-controlled trial.Lancet.2021;397(10268):51-60.NurtecODT/Vydura is the First And Only Medication Approved For The Acute Treatment of Migraine and Preventive Treatment of Episodic Migraine in Adults1Provides Sustained Pain Freedom Through 48 hours2Reduces MonthlyMigraine Days3Established
70、 Safety and Tolerability1MigraineNurtecODT/VyduraProvides Flexibility to Patients and Physicians19Near-Term Launches High-Value Pipeline Day|Total Rx Volume-Oral CGRPs(11/18)1Since Launch,Nurtec ODT Continues To Show Robust Growth CGRP:calcitonin gene-related peptide;TRx:total prescriptions;HCP:heal
71、thcare professional.Source:1.TRx numbers 1/24/20 11/18/22,IQVIA SMART,accessed 11/28/22.Note:Market definition for share calculations is based on oral CGRP receptor antagonists.2.Internal Net Sales Data.MigraineCommercial Strategy Market Performance600,000Unique PatientsSince Launchin February 20202
72、90K HCPsUnique PrescribersSince Launch in February 2020250.7%TRx Share+6.4%Pt Increasefrom May-Nov 2022111/18NurtecODT Performance Highlights in the U.S.Market20Near-Term Launches High-Value Pipeline Day|596,068298,487202,5493Q22Quarterly TRx VolumeTRx Share1US Migraine Market Is Expected to Grow to
73、 40+Million Scripts;Oral CGRPs are the Fastest Growing ClassSource:1.IQVIA NPA data through October 2022.Accessed 11/21/22.High Growth Potential Within A Rapidly Growing MarketMigraineIn 2021 Oral CGRPs Reached$1B in Net Sales While Only Accounting for 5-6%of Migraine ScriptsSource:1.TRx numbers cov
74、er 3Q2022,IQVIA SMART,accessed 10/17/22.2.NBRx numbers cover 3Q2022,IQVIA NPA,accessed 10/17/22.3.Oral CGRPs=Nurtec ODT,Ubrelvy,and Qulipta.Market PotentialQuarterly NBRx VolumeOral CGRPs vs Triptans+Topiramate23,942,4132,974,2241,089,3743Q22TopiramateOral CGRPs3TriptansOral CGRPs vs Triptans+Topira
75、mate16%23%TopiramateOral CGRPs3Triptans21Near-Term Launches High-Value Pipeline Day|Nurtec ODT/Vydura 1stand only dual indication therapy in the oral-CGRP class and US market leader4Building a Franchise to Potentially Meet the Needs of People with Migrainezavegepant oralPhase 3MigraineMigraine Treat
76、ment algorithmSource:1.https:/www.ichd-3.org/1-migraine/.2.Ailani J,et al.,Headache.2021 Jul;61(7):1021-1039.3.Blumenfeld AM et al.Cephalalgia.2011;31(3):301-315.4.Xponent Plantrak accessed 11/4/2022 Market definition for share calculation based on Nurtec ODT Ubrelvy,and Qulipta.;5.Pavlovic,JM,et al
77、,Efficacy And Safety Of Zavegepant Nasal Spray for the Acute Treatment of Migraine:Results of a Phase 3 Double-Blind,Randomized,Placebo Controlled Trial,AHS Annual Meeting,June 2022.Note:Primary endpoints were freedom from pain and freedom from most bothersome symptom(MBS)at 2 hours;statistically si
78、gnificant secondary endpoint demonstrated pain relief at 15 min post-dose with zavegepant compared to placebo.Vydura is indicated for prevention of episodic migraine in patients who have at least 4 migraines a month.Nurtec is only approved for the preventive treatment of episodic migraine.*zavegepan
79、t intranasal,subject to regulatory approval,would be indicated for acute treatment.Episodic(14)Chronic(15+)Acute TreatmentPreventive TreatmentNurtecODT/VyduraIs Well-Positioned for Leadership,with zavegepant*Potentially Bringing the Opportunity for Portfolio Playzavegepant intranasal(Subject to regu
80、latory approval)Complementary treatment option for situations where speed of pain relief is most relevant5Potential First CGRP with intranasal formulation,pending FDA approvalAcute TreatmentType of Migraine(Headache Days Per Month)1,2,322Near-Term Launches High-Value Pipeline Day|Significant Potenti
81、al to Build a Blockbuster Migraine Portfolio Tx:Treatment,ODT:Orally Disintegrating Tablets Note:All population sizes,treatment rates,and market share are estimates.Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial s
82、uccess and availability of supply.Nurtec is approved for the acute treatment of migraine in adults(18+)and the preventive treatment of episodic migraine in adults(18+).*zavegepant intranasal,subject to regulatory approval,would be indicated for acute treatment.A Closer Look at Key Drivers of Potenti
83、al Migraine RevenuesMigraineMigraine Portfolio-Market PotentialNurtecODT/Vydurazavegepant Intranasal*zavegepant OralIndicationAcute TreatmentEpisodic PreventionAcute TreatmentChronic PreventionMigraine PopulationUS Diagnosed Adults(age 18+)16 M14.6 M16 M1.4 MTreatment Rate40 50%20 25%40 50%35 40%Tre
84、ated Patients6.4 8M2.9 3.7M6.4 8M0.5 0.6 MPotential Peak Share(Among Treated Patients)13%8%6%8%Average Utilization48 tablets/year96 tablets/year24 nasal sprays/year256 tablets/yearPeak Year Sales Worldwide$6B23Near-Term Launches High-Value Pipeline Day|Expand customer base to include 250+US health s
85、ystems with leading account management;provide 8x more field medical supportContinue momentum and unlock HCP trial and adoption with PCPs who are CGRP class-nave by increasing the number of reps detailing NurtecODT in the USIn the process of seeking regulatory approvals Ex-US and planning to launch
86、in 70+markets globally over the long term*Bring Pfizers US launch expertise for zavegepant Intranasal(2023)*,a potential first-in-class nasally administered CGRP inhibitorCommercial Strategy:Amplifying the Migraine PortfolioSuccess in 2023&Beyond Will Be Driven By Current Momentum and ExpandingReach
87、 Across the Globe*Subject to regulatory approval and commercial availability(US PDUFA Q1 2023);HCP:healthcare professional;PCP:primary care physician;CGRP:calcitonin gene-related peptide.MigraineMigraine-Commercial Strategy24Near-Term Launches High-Value Pipeline Day|Growth Trajectory to Potential$6
88、B Peak Year Sales for NurtecODT/Vyduraand zavegepant worldwide(est.)Note:Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply.Pfizer Is Well-Positioned to Become a Leader in MigraineMi
89、graineMigraine Portfolio-Market PotentialHigh Unmet NeedPfizers migraine portfolio can help address patients unmet needsMigraine PortfolioWe are taking Nurtec ODT to the next level in the USExpand in USand moving at lightspeed to launch across the globeLaunch Globally25Respiratory Syncytial Virus(RS
90、V)PreF Vaccine CandidateSinan AtligUS Commercial and Global Business Lead for Vaccines December 12,202226Near-Term Launches High-Value Pipeline Day|Disease Overview&Demographics:Respiratory Syncytial Virus(RSV)Contagious Virus That Can Cause Serious,Sometimes Life Threatening,Respiratory Illness1.Li
91、 Y,et al(2022).Lancet 399(10340):2047-2064.2.Obando-Pacheco P,Justicia-Grande AJ,Rivero-Calle I,et al.J Infect Dis.2018;217(9):1356-1364.3.Falsey et al,NEJM(2005).4.Estimated Influenza Disease Burden 2015-2016 through 2019-2020,CDC(2022)5.Respiratory Syncytial Virus in Older Adults:A Hidden Annual E
92、pidemic,A Report by the National Foundation for Infectious Diseases,September 2016RSVRSV-Disease Overview&DemographicsRSV in Infants A leading cause of global infant respiratory disease1,2 Sickens 6.6M infants resulting in 45K deaths globally each year1RSV in Older Adults(65 years)Common cause of se
93、vere respiratory illness,with disease burden similar to influenza3,4 177,000 hospitalizations and 14,000 deaths annually in the U.S.5Currently No Vaccine to Help Prevent&No Specific Therapeutic to Help Treat RSV Disease27Near-Term Launches High-Value Pipeline Day|*Subject to regulatory approval.1 Fa
94、lsey A.,et al.J.Infect Dis 2022;225(12):2056-2066.2Walsh E.,et al.J.Infect Dis 2022;225(8):1357-1366.3Baber J.,et al.J.Infect Dis 2022 May 11;jiac189.Pfizers RSVpreF Vaccine Candidate OverviewRSVRSVpreF OverviewVaccineBivalent stabilized prefusion F Sequence based on contemporary RSV A and RSV B str
95、ains Elicited high neutralizing titers for both RSV A and RSV B in Phase 1/2 studies1,2,3 No adjuvant or viral vector componentOnly RSV Vaccine Candidate Targeting Indications for Older Adult&Maternal Immunization*MaternalImmunize pregnant women to prevent RSV-associated lower and severe lower respi
96、ratory tract illness(LRTI)in infants from birth through 6 months of ageOlder Adult Active immunization to prevent RSV-associated LRTI in adults 60 years of age28Near-Term Launches High-Value Pipeline Day|Efficacy during second season to be assessedBLA=Biologic License Application;PDUFA=Prescription
97、Drug User Fee Act;DMC=Data Monitoring Committee 1.Acute respiratory illness:1 respiratory symptom lasting more than 1 day.2.Lower respiratory tract illness:ARI with 2 or 3 lower respiratory signs/symptoms.RSV Older Adult:BLA Granted Priority Review with Potential PDUFA May 2023RSVRSVpreF Overview Ol
98、der AdultsOutcomeEfficacy(1 Season)RSV acute respiratory illness(ARI)162%RSV lower respiratory tract illness 2 symptoms267%RSV lower respiratory tract illness 3 symptoms286%Higher efficacy against more severe outcomes Strong efficacy Consistent efficacy observed across age and comorbidity subgroups
99、DMC indicated vaccine was well tolerated,with no safety concerns;local&systemic events were mostly mild to moderate and short lived No adjuvant or viral vector componentPhase 3 RENOIR Study Interim Analysis Systemic Events,by Maximum Severity,Within 7 Days After Vaccination27.4%25.7%15.5%14.4%12.8%1
100、1.7%10.1%8.4%7.5%6.9%5.9%5.2%3.4%3.7%1.4%1.4%0.9%0.8%0510152025303540RSVpreF120gPlaceboRSVpreF120gPlaceboRSVpreF120gPlaceboRSVpreF120gPlaceboRSVpreF120gPlaceboRSVpreF120gPlaceboRSVpreF120gPlaceboRSVpreF120gPlaceboRSVpreF120gPlacebo MildModerateSevereGrade 4Fatigue1Headache1Muscle Pain1AnyDiarrhea2Na
101、usea1Fever3Joint Pain1Vomiting41001Severity definition:mild=no interference with daily activity;moderate=some interference with daily activity;severe=prevents daily activity2Severity definition:mild=2-3 loose stools in 24h;moderate=4-5 loose stools in 24h;severe=6 or more loose stools in 24h3Severit
102、y definition:mild 38.0C-38.4 C;moderate 38.4C-38.9 C;severe 38.9C-40.0 C;grade 4 40.0 C4Severity definition:mild=1-2 time(s)in 24h;moderate=2 times in 24h;severe=requires intravenous hydrationRSVpreF N=3619-3621:Placebo N=3532-353929Near-Term Launches High-Value Pipeline Day|*Subject to regulatory a
103、pprovalMATISSE:MATernal Immunization Study for Safety and Efficacy MA-LRTI=Medically Attended Lower Respiratory Tract Illness DMC=Data Monitoring Committee1 Munoz 2019:2 Parikh,et al.,2017:3 Li Lancet 2022:RSV Maternal Immunization:Help Protect Infants from Severe RSV*Immediately at BirthRSVRSVpreF
104、Overview Maternal Maternal immunization with RSVpreF is designed to protect infants from birth through the first 6 months of life,when the risk of severe RSV is greatest1,2,3Results met study protocols pre-specified regulatory success criteria for severe MA-LRTI;although statistical significance was
105、 not met for MA-LRTI endpoint,clinically meaningful efficacy was observed through six months of ageDMC indicated RSVpreF investigational vaccine was well-tolerated with no safety concerns for either vaccinated individuals or their newborns Primary Endpoint:Severe MA-LRTI Vaccine EfficacyFirst 90 day
106、s of life81.8%(CI:40.6%,96.3%)Six-month follow-up69.4%(CI:44.3%,84.1%)Confidence intervals are 99.5%CI at 90 days and 97.58%CI at later intervals.Phase 3 MATISSE Study Interim Analysis Primary Endpoint:MA-LRTI Vaccine EfficacyFirst 90 days of life57.1%(CI:14.7%,79.8%)Six-month follow-up51.3%(CI:29.4
107、%,66.8%)30Near-Term Launches High-Value Pipeline Day|Commercialization Approach:Pfizer Vaccines Commercial LeadershipRSVRSVpreF-Commercial ApproachRobust and Differentiated Contracting ModelsProven and Reliable Manufacturing and Distribution Longstanding and Deep Relationships with Key StakeholdersL
108、eading Share of Voice Among Consumers Decades of Vaccines Launch Excellence31Near-Term Launches High-Value Pipeline Day|Note:Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply.*All p
109、opulation sizes,vaccination rates,penetration rates,recommendations,and market share are estimates.RSV Vaccine Candidate:Potential Revenues More Than$2BnRSVRSVpreF-Commercial OpportunityMaternal ImmunizationOlder AdultsPopulation(US)3.5-4 Million(annual birth cohort)61 Million(65 yrs)New aged-in coh
110、ort 3.5-4 Million annuallyPeak Vaccine Uptake 60-70%50-60%Market Share100%45-60%RecommendationRoutine,Year RoundRoutine,Age BasedDuration of Protection180 days(current data)1-2 yearsRevaccinationEach pregnancyEvery Other YearPeak Sales Year20272027Key Drivers of Potential RSV Vaccine Revenues(Intern
111、al Assumptions-US)32Near-Term Launches High-Value Pipeline Day|RSVInfluenzaPotential Combination Vaccine Candidates*Subject to regulatory approval Subject to clinical trial success1 PAXLOVID is authorized in the US for emergency use only,and is not approved for any useNote:Preliminary,subject to cha
112、nge,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply.Pfizers Respiratory Portfolio:Strong Legacy,Future PotentialRSVRSVpreF-Respiratory PortfolioRSVPreF*Sisunatovir*(Treatment)Pneumococcal PneumoniaTodayTodayTo
113、morrow(potential)(Treatment)1COVID-19mRNA Flu*mRNA Flu/COVID*Potential additional combination respiratory vaccine*33Etrasimod Ulcerative Colitis(UC)Kevin SullivanGlobal Specialty Care&US PresidentDecember 12,2022Breakthroughs that change patients lives34Near-Term Launches High-Value Pipeline Day|Dis
114、ease Overview&Demographics:Ulcerative Colitis“A UC diagnosis is a life sentence that wreaks havoc on the body.It turns any day to chaos in an instant.”1Sources:1)FCB Qualitative UC Patient Research.2)Extrapolation to US population today from Clin Gastroenterol Hepatol.2017 June;15(6):857863.3)Ords I
115、 et al.Lancet.2012;380:1606-1619.4)Danese S,Fiocchi C.N Engl J Med.2011;365:1713-1725.5)US data,Mayo Clinic in Olmsted County,MN;data sourced May 4,2022 Etrasimod UCUlcerative Colitis-Disease Overview and DemographicsSymptoms include chronic diarrhea with blood and mucus,abdominal pain&cramping,and
116、weight loss,which can interfere with work,family and social activitiesToday,even with multiple therapeutic options available,up to 30%of UC patients still progress to colectomy3,450%of patients are diagnosed with UC by the age of 35,impacting active and formidable years in patients lives5Ulcerative
117、Colitis(UC)is a chronic and often debilitating inflammatory bowel disease that affects an estimated 1 million people in the US235Near-Term Launches High-Value Pipeline Day|The UC Patient ExperienceUC is a Debilitating Disease That is Difficult for Those Not Suffering to UnderstandSource:1)Internal P
118、atient Research.Etrasimod UCUC Patient Experience You never know when its going to strike you and I mean that sincerely;you can have plans and they get messed up because you have a bout.Its not only the physical feeling of having UC which is bad enough,but really,its the emotional and the mental asp
119、ect of it all1 UC Patient36Near-Term Launches High-Value Pipeline Day|Current Treatment Landscape:Ulcerative Colitis Majority of UC Patients are on Conventional Therapies and Many Struggle to Achieveand Maintain Remission*Subject to regulatory approval and labeling.Sources:1)IQVIA US LRx/Dx data.Qua
120、lified patients have 1+advanced treatment(bio/JAK)OR 1+conventional treatment(5-ASA/IM)OR 1+adjuvant treatment(steroids)during the selection period 01 Apr 2019 to 31 Mar 2021;AND 1+diagnosis for UC in the 90 days preceding the first observed treatment;AND no confounding diagnoses after the UC diagno
121、sis immediately preceding the first treatment observed in the selection period.Newly treated patients have no prior UC treatment in the 24 months preceding the first treatment observed in the selection period.Patients are observed from their first treatment in the selection period through 31 Mar 202
122、2.2)HCP Reported,Q2 2022 US HCP ATU.Tx:Treatment|UC:Ulcerative Colitis|IM:Immunomodulators|5-ASA:5-Aminosalicylates|ROA:Route of Administration|IV:Intravenous|SC:Subcutaneous|AT:Advanced treatmentEtrasimod UCUC Treatment LandscapeUC Treated Patients New to Tx&Already on Tx1All UC Patients:Mild,Moder
123、ate&Severe DxSteroid Only13%Conventional Therapy(5-ASA&IM)51%Advanced Therapy(Biologic/JAK)36%Conventional Sub-Optimal/Failure27%ConventionalMaintained53%Bio Switch30%Bio Maintained48%Bio Sub-optimal22%Steroid Only20%Steroid+Conventional64%of Steroid+Conventional Therapy Sub-group:%of Advanced Thera
124、py Sub-group:Bar sizes are approximationsMedian observation period=1,051 daysPotential etrasimod targets,if diagnosed with moderately active to severely active UC*38%of patients on conventional therapy were not prescribed advanced treatment due to patient safety/side effect or ROA(IV/SC)concerns252%
125、Of UC patients on AT dont retain long-term remission1Per HCPs37Near-Term Launches High-Value Pipeline Day|Significant Potential Remains for Oral Therapies in 1L Advanced Tx(AT)Given Current SOC Options,Movement into 1L AT Today Often Means Movement Away fromPatient Preferred Oral Therapy1Etrasimod U
126、CUC Treatment Landscape1L:First Line|AT:Advanced Treatment|SOC:Standard of Care|Tx:TreatmentSource:1)Internal Q2 2022 Awareness,Trial,Usage(ATU)Survey,USCyclosporine/Tacrolimus/Surgery 5-Aminosalicylate5-AminosalicylateOral Unmet Need Remains:CorticosteroidsImmunosuppressivesJAK InhibitorsJAK Inhibi
127、torsBiologics/BiosimilarsBiologics/BiosimilarsTimeDisease SeverityStep-Up Opportunity for Patients Sub-optimally Controlled on Conventional TherapyPre-Arrival of S1Ps:UC Treatment Paradigm89%Of advanced nave patients prefer oral therapy1InductionMaintenanceOralInfusion(IV)Subcutaneous Injection38Nea
128、r-Term Launches High-Value Pipeline Day|Etrasimod*Overview:The Next S1P With a High Potential Emerging ProfileIf Approved,a New S1P with High Potential to Become the Preferred 1L Advanced Treatment(AT)Option by Balancing a Favorable Benefit:Risk Profile and Oral AdministrationSources:1)Feagan B,et a
129、l.Presented at:United European Gastroenterology Week 2022;Vienna,Austria.Poster MP289.2)Sandborn W,et al.Presented at:Digestive Disease Week 2022;San Diego,CA.Etrasimod 2 mg Once Daily as Treatment for Moderately to Severely Active Ulcerative Colitis:Results From the Phase 3 ELEVATE UC 52 and ELEVAT
130、E UC 12 Trials.MMS,Modified Mayo Score;Data were from reported randomized strata.Percent of patients with clinical remission at Week 12 was derived from Cochran-Mantel-Haenszel analysis.Etrasimod UCEtrasimod-OverviewKey Potential Differentiatorsas a Pre-Biologic Option*ELEVATE UC 12 and ELEVATE UC 5
131、2 Primary Endpoints:Clinical Remission2Safety profile and precedents support potential for no boxed warning(pending final approved labeling)Trials conducted with once-daily oral dosing;data support initiation without complex up-titration regimenSingle-dose oral formulation provides cost predictabili
132、ty and could alleviate burden on infusion sites&health systemsStrong efficacy shown in AT-nave patients1100%of patients in clinical remission after 1-year were also steroid free2If approved,potentially filling the continued need for oral AT options after conventional therapy failure and before biolo
133、gics beginSeparate studies conducted independently;not head-to-head trials.ELEVATE-52:Baseline MMS 5 to 9(N=409)ELEVATE-12:Baseline MMS 5 to 9(N=334)Clinical remission defined as SF subscore=0(or 1 with a 1-point decrease from baseline),RB subscore=0,and ES 1(excluding friability).Adverse Events:Tre
134、atment-emergent AEs,including serious AEs,were similar between treatment groups in both trials.Most common treatment-emergent AEs in 3%or more of etrasimod-treated patients and greater than placebo up to week 52 in either trial were headache,worsening of UC,COVID-19 infection,dizziness,pyrexia,arthr
135、algia,abdominal pain and nausea.No reports of bradycardia or atrioventricular block as serious AEs.Strong Clinical Remission in Oral Form27.0%32.1%ELEVATE-52Baseline MMS 5 to 9(N=409)24.8%ELEVATE-12 Baseline MMS 5 to 9(N=334)Amongst all enrolled patients*UC=Ulcerative Colitis|AT=Advanced Treatment;i
136、ncludes biologics and JAKs*Subject to regulatory approval and labeling.*Week 52 response rate amongst all enrolled pts,not just among responders at end of induction like many UC trials.39Near-Term Launches High-Value Pipeline Day|Ulcerative Colitis Marketed Tx Competitive LandscapeFor Advanced-Nave
137、Patients,HCPs Top Prescribing Considerations Span Product Attributes&Company/Brand Perceptions*Anti-integrin only subcutaneous(SC)ex-US.*IL12/23 IV for first infusion and SC thereafter.JAKi therapies in the US are restricted to 2L+advanced treatment use per labelSources:1)Internal Demand Study,Q2 20
138、22.2)Internal Patient&HCP Q2 2022 ATUs.3)Pivotal Ph.3 Clinical Trials and product labels.Etrasimod UCUC-Competitive LandscapeHCP Reported Top Drivers of Prescribingfor Advanced-Nave Patients1,2TNFiAnti-IntegrinIL12/23JAKiClass Boxed Warning3Route of Administration3Clinical Remission3Steroid-free Rem
139、ission3Perception Patients May Quickly Accept Tx Recommendation1,2Trust&Experience1,2Boxed WarningBoxed WarningNo Boxed WarningNo Boxed WarningUC Treatment Landscape:Marketed MOAs Past/Pre-Arrival of S1PsData represented are not based on H2H studies.Analysis is anindirect comparison of labels and HC
140、P derived drivers of prescribing.*Meets requirementDoes not always meet requirementNot reported due to recency of launchOralInfusion(IV)Subcutaneous Injection 40Near-Term Launches High-Value Pipeline Day|Arrival of the S1P Class to IBD(2021)Provided the return of anOral Option for 1L Advanced Tx Pat
141、ients*Anti-integrin only subcutaneous(SC)ex-US.*IL12/23 IV for first infusion and SC thereafter.JAKi therapies in the US are restricted to 2L+advanced treatment use per label.Sources:1)Internal Demand Study,Q2 2022.2)Internal Patient&HCP Q2 2022 ATUs.3)Pivotal Ph.3 Clinical Trials and product labels
142、.4)Internal LAAD analysis,US June-August 2022 data.Ulcerative Colitis Marketed Tx Competitive LandscapeEtrasimod UCUC-Competitive LandscapeMeets requirementDoes not always meet requirementNot reported due to recency of launchOralInfusion(IV)Subcutaneous Injection Data represented are not based on H2
143、H studies.Analysis is anindirect comparison of labels and HCP derived drivers of prescribing.UC Treatment Landscape:Marketed MOAs Current/Post-Arrival of S1PsHCP Reported Top Drivers of Prescribing for Advanced-Nave Patients1,2S1PNew to Market 2021 TNFiAnti-IntegrinIL12/23JAKiClass Boxed Warning3Rou
144、te of Administration3Clinical Remission3Steroid-free Remission3Perception Patients May Quickly Accept Tx Recommendation1,2Trust&Experience1,2Boxed WarningBoxed WarningNo Boxed WarningNo Boxed Warning*No Boxed Warning 50%of priority market regulatory submissions achieved ahead of plan for etrasimod43
145、Near-Term Launches High-Value Pipeline Day|Blockbuster Potential Global Annual Peak RevenuesSources:1)Internal market size estimates;diagnosed prevalence literature review and market-level data analysis.2)US RWD Mkt Scan/Optum Claims analysis 2018-2021;all UC patients(mild-to-moderate and moderate-t
146、o-severe);JP RWD MDV 2018-2021;ROW internal research estimates.3)IQVIA LRx/Dx data,period 01 Apr 2019 to 31 Mar 2021.Analyzed April 2022;ROW internal research estimates.4)Evaluate Pharma Ulcerative Colitis Indication Overview Summary published on 28 October 22.UC:Ulcerative Colitis|Dx:Diagnosed|Rx:P
147、rescription|ROW:Rest of worldEtrasimod UC Market PotentialEtrasimod UCEtrasimod-Market Potential in UCEtrasimod in Ulcerative Colitis(UC)1.7M+UC Dx prevalence in top 5 developed markets180%Rx treated patients2Up to 35%Advanced treated patients350%Expected market growth in next 5 years4$1-2BGlobal re
148、venue potentialNote:Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply.44RitlecitinibAlopecia Areata(AA)Kevin SullivanGlobal Specialty Care&US PresidentDecember 12,2022Breakthroughs
149、that change patients lives45Near-Term Launches High-Value Pipeline Day|AA is an Autoimmune Disease Characterized by Patchy or Complete Hair Loss on the Scalp,Face and or Body5-9Sources:1.Suchonwanit P,et al.Immunotargets Ther.2021;10:299-312.2.Gilhar A,et al.Autoimmun Rev.2016;15(7):726-735.3.Islam
150、N,et al.Autoimmun Rev.2015;14(2):81-89 4.Lee et al.Journal of the American Academy of Dermatology.2020 Mar 1;82(3):675-82 5.Suchonwanit P,et al.Immunotargets Ther.2021;10:299-312 6.Islam N,et al.Autoimmun Rev.2015;14(2):81-89 7.Cranwell WC,et al.Australas J Dermatol.2019;60(2):163-170 8.Gilhar A,et
151、al.Autoimmun Rev.2016;15(7):726-735.9.Pratt CH,et al.Nat Rev Dis Primers.2017;3:17011 10.Villasante Fricke AC,Miteva M.Clin Cosmet Investig Dermatol.2015;8:397-403.11.Alzolibani AA.Acta Dermatovenerol Alp Pannonica Adriat.2011;20(4):191-198.12.Goh C,et al.J Eur Acad Dermatol Venereol.2006;20(9):1055
152、-1060.13.Mirzoyev SA,et al.J Invest Dermatol.2014;134(4):1141-1142.14.Lee H,et al.J Am Acad Dermatol.2020;83(4):1064-1070.15.Harries M,et al.Br J Dermatol.2022;186(2):257-265.16.Ramos PM,et al.An Bras Dermatol.2020;95(suppl 1):39-52.17.Rossi A,et al.G Ital Dermatol Venereol.2019;154(6):609-623 18.On
153、line survey of 216 patients with self-reported moder AA.Mesinkovska N,et al.J Investig Dermatol Symp Proc.2020;20(1):S62-S68.Disease Overview and Demographics:Alopecia Areata(AA)Ritlecitinib AARitlecitinib-Alopecia Areata-Disease Overview and DemographicsAA can affect all ages and typically occurs b
154、y age 40Age9-11 AA can affect all genders Gender10,12,13AA can affect people of any race/ethnicityRace/Ethnicity14-17AA burden can include physical,psychosocial and productivity impactPatient Impact18Alopecia Totalis(AT)Alopecia Universalis(AU)PatchyAlopecia AreataSmall round bald spots on the scalp
155、Total loss of hair on the scalpTotal loss of hair on the scalp,face&bodyPatient portrayalActual patient Actual patient Other AA presentations include Alopecia incognita,Ophiasis,Sisaipho Images property of Pfizer Inc.All rights reserved.AA Can Affect Up to 2%of the Global Population Over the Course
156、of Their Lifetime1-4,1046Near-Term Launches High-Value Pipeline Day|Every day since I found that first patchI have thought I am damaged,abnormal,unfeminine,or ugly because of my hair loss.1Studies of Adults and Adolescents Have Shown6,7:Sources:1.US Food and Drug Administration.The Voice of the Pati
157、ent.https:/www.fda.gov/media/112100/download.Published March 2018.Accessed September 6,2022.FDA=US Food and Drug Administration.Participants included patients with AA,totalis,or universalis(N=95),who were aged 18 years and residing in the United Kingdom 2 Maghfour J,et al.Dermatology.2021;237(4):658
158、-672.3 Senna M,et al.Adv Ther.2021;38(9):4646-4658.4.Toussi A,et al.J Am Acad Dermatol.2021;85(1):162-175.5.Lee S,et al.J Am Acad Dermatol.2019;80(2):466-477.e16.6.Mesinkovska N,et al.J Investig Dermatol Symp Proc.2020;20(1):S62-S68 7.Aldhouse et al.Journal of Patient-Reported Outcomes(2020)4:76The
159、Alopecia Areata Patient Experience Ritlecitinib AARitlecitinib-Alopecia Areata-Disease Educationof patients report that coping with Alopecia Areata is a daily challenge85%of patients report withdrawing from social activities after their first episode of hair loss60%of patients have said theyve misse
160、d work,or even left their jobs due to their hair loss45%of patients describe feeling insecure,inadequate and self-conscious as a result of how they look50%Actual patientImages property of Pfizer Inc.All rights reserved.AA Can Cause Considerable Burden for Patients,Beyond Hair Loss1-5Alopecia areata
161、changed my life,my mind&my heart.It made me weak&vulnerable,battered myself-esteem&heightenedmy insecurities.147Near-Term Launches High-Value Pipeline Day|Source:Pfizer AA Patient Journey Current Treatment Landscape:Alopecia Areata Ritlecitinib AARitlecitinib-Alopecia Areata Treatment LandscapeCurre
162、nt standard of care has significant limitations Limited efficacy Burdensome for patients/dozens of injections per month High level of treatment dropout Not appropriate for extensive disease Not approved for AA in US&EU Ritlecitinib(TEC/JAK3)subject to regulatory approvalTopical/Intralesional Steroid
163、s Oral Treatments Oral steroids not appropriate for long-term useOne recently approvedoral treatment(JAK1/2)High Level of Dissatisfaction with Standard of Care(e.g.,Topical and Intralesional Steroids)Initial Hair Loss&Self Treatment HCP Presentation&Diagnosis 48Near-Term Launches High-Value Pipeline
164、 Day|Clinical Results ALLEGRO-2b/3Clinical Photos ALLEGRO 2b/343.231.20102030405002468 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48The efficacy and safety of ritlecitinib were evaluated in a pivotal,Phase2b/3,double-blind,placebo-controlled study(ALLEGRO)|Primary endpoint for overall
165、ALLEGRO study is response based on absolute Severity of Alopecia Tool(SALT)Score 20 at Week 24|At baseline,patients had 50%scalp hair loss,including 46%who had AT or AU|After 24 weeks,all patients on placebo were randomized to ritlecitinib on either one of two regimens:200 mg QD for four weeks follo
166、wed by 50 mg for 20 weeks,or 50 mg for 24 weeks(data not shown)Sources:Clinical results and Patient B photos from King B,et al.Efficacy and safety of ritlecitinib(PF-06651600)in patients with alopecia areata and 50%scalp hair loss:results from the international ALLEGRO Phase 2b/3 randomized,double-b
167、lind,placebo-controlled Study(NCT03732807).Poster presented at the 30th Congress of the European Academy of Dermatology and Venereology(EADV);September 29October 2,2021;Patient A photos Data on File Ritlecitinib Overview in Alopecia AreataRitlecitinib AARitlecitinib-OverviewNot all patients taking R
168、itlecitinib achieved these results.As with all medications,results may vary.Ritlecitinib safety profile in ALLEGRO-2b/3 was consistent with previous studies.Overall,the percentage of patients with adverse events(AEs),serious AEs and discontinuing due to AEs was similar across all treatment groups.Th
169、e most common AEs seen in the study were nasopharyngitis,headache and upper respiratory tract infection.Images property of Pfizer Inc.All rights reserved.WeeksProportion(%)of participants with SALT 20(95%CI)Robust Clinical Data Support Transformative Potential01020304050Ritlecitinib 50 mg QDRitlecit
170、inib 30 mg QDPlaceboProportion(%)of participants with SALT 20(95%CI)SALT 20 Week 2423.4%14.3%1.5%SALT 20 Week 48Ritlecitinib 50 mg QDRitlecitinib 30 mg QDPlaceboWeek 48Week 24BaselinePatient APatient B49Near-Term Launches High-Value Pipeline Day|*Subject to regulatory approvalCommercialization Appro
171、ach:Ritlecitinibs*Potential Future OpportunityRitlecitinib AARitlecitinib Commercial ApproachFirst and only dual-selective TEC family/JAK3 inhibitor;sparing inhibition of other JAKsData in adults and adolescentsData on complete or near-complete scalp hair regrowth Potential for sustained hair regrow
172、thFavorable benefit/risk profile Profile supports long-term usePotential to Redefine the Standard of Care in Alopecia Areata*50Near-Term Launches High-Value Pipeline Day|Develop the MarketUnlock AccessDrive Adoption11Subject to regulatory approvalMedical Dermatology and Specialty Care Commercializat
173、ion Expertise Ritlecitinib AARitlecitinib Commercialization Approach in Medical Dermatology Pre-launch omnichannel approach providing unbranded stakeholder education on AA disease and its associated patient burden Close collaboration with Patient Advocacy GroupsPoised for a Potential Best-in-class L
174、aunch Advocate for adequate AA coverage and reimbursement Articulate to payers the unmet need and impact of AA on patients lives Customized Pfizer Dermatology patient access platform Industry-leading capabilities in patient activation Position ritlecitinib as HCP treatment of choice for systemic-app
175、ropriate patients51Near-Term Launches High-Value Pipeline Day|Sources:1.Inclusive of G7 countries:population data using UN Data from 2019;adult prevalence data obtained from Benigno overall self-report(all age groups),CCID 2020;French 18+Prevalence:Richard,JEADV 20182.Benigno M,Anastassopoulos KP,Mo
176、staghimi A,et al.A Large Cross-Sectional Survey Study of the Prevalence of Alopecia Areata in the United States.Clin Cosmet Investig Dermatol.2020;13:259-2663.NHWS 2019-2021,US Longitudinal Claims 2019,US Epi Claims 2016-2019;growth rate avg of linear trend thru 2029 of NHWS and US Epi Claims year-o
177、ver-year change4.PFE projections for peak based on 2021 demand researchRitlecitinib Alopecia Areata Market PotentialRitlecitinib AARitlecitinib Market Potential in Alopecia AreataRitlecitinib in AA6.4MAdult AA prevalence(1)43%50%scalp hair loss(2)2849%Diagnosed and seeing a Dermatologist(3)3846%Cand
178、idates for advanced treatment(4)$1BGlobal revenue potentialNote:Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply.Blockbuster Potential Global Annual Peak Revenues52ElranatamabPoten
179、tial to Bring Transformative Outcomes to More Patients in Multiple MyelomaSuneet VarmaGlobal Oncology&US PresidentDecember 12,202253Near-Term Launches High-Value Pipeline Day|MM is the Second Most CommonHematologic Malignancy Worldwide1Despite Advances That Have Improved Survival,MM Remains Incurabl
180、e,With Most Patients Progressing to RRMM5MM=multiple myeloma;RRMM=relapsed or refractory multiple myeloma;mDOR=median duration of response;TCE=triple class exposed.*Data from an ongoing,prospective,non-interventional study detailing the use of real-life current SOC in the treatment of RRMM patients
181、who have received 3 prior lines of therapy(LOT)or were double refractory to a PI and an IMiD across 76 sites,including 63 in Europe(Belgium,France,Germany,Italy,Netherlands,Poland,Russia,Spain,and the United Kingdom)and 13 in the United States;248 patients were enrolled between August 2,2019 and Oct
182、ober 26,2020.References:1.Kazadjian D.Semin Oncol.2016;43(6):676-681.2.Awad K,et al.The Pharmaceutical Journal.2020;online:DOI:10.1211/PJ.2020.20207147.3.GCO.https:/gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf.Accessed November 7,2022.4.1NIH Surveillance,Epidemiology,
183、and End Results(SEER)Program.5.Nadeem O,Tai YT,Anderson KC.Immunotherapeutic and targeted approaches in multiple myeloma.Immunotargets Ther.2020;9:201-215.doi:10.2147/ITT.S240886.6.Shah N,Chari A,Scott E,Mezzi K,Usmani SZ.B-cell maturation antigen(BCMA)in multiple myeloma:rationale for targeting and
184、 current therapeutic approaches.Leukemia.2020;34:985-1005.doi.org/10.1038/s41375-020-0734-z.7.Chim CS,Kumar SK,Orlowski RZ,et al.Management of relapsed and refractory multiple myeloma:novel agents,antibodies,immunotherapies,and beyond.Leukemia.2018;32:252-262.doi:10.1038/leu.2017.329.8.Mateos MV,et
185、al.Leukemia.2022;36:13711376.Disease Overview&Demographics:Multiple Myeloma(MM)ElranatamabElranatamab-Multiple Myeloma-Demographics and Epidemiology;Disease Education7.4 months mDOR for triple class exposed(TCE)patients*,8New treatments are needed for patients that explore novel therapeutic targets
186、and modalities counter mechanisms that lead to treatment resistance,including immune evasion5,6Each relapse for patients with MM results in6,7:Higher risk of treatment resistanceShorter remissionLesser responses to standard treatments13%of hematologic malignanciesin 2020 were MM2(18%of those in the
187、US)176,404new cases of MMworldwide in 20203(32K new cases in the US in 2020)54%5-year survival rate41%of all new cancercases in 2020 were MM354Near-Term Launches High-Value Pipeline Day|T-cell activationCancer cell death123Elranatamab Bispecific Antibody MechanismBCMA Bispecific Antibodies(BsAbs)hav
188、e potential to be the preferred modality for treating Multiple Myeloma,promising efficacy and broad availabilityCAR-T=chimeric antigen receptor T cell therapy;ADC=antibody drug conjugate;BCMA=B-cell maturation antigen;BsAbs=bispecific antibodies;CR=complete response;SC=subcutaneous;RRMM=relapsed or
189、refractory multiple myeloma.*Quotes are from blinded market research and represent third-party perceptions of investigational modalities.Characterization is based on available data comparing across trials,not head-to-head data.Source:Drivers and Barriers(US).ZS Associates.April 2021.BCMA-Targeted Tr
190、eatments in Relapsed or Refractory Multiple MyelomaElranatamabElranatamab-BCMA-Targeted Treatments in RRMMBi-specific antibody brings together T-cell&myeloma cell1Proximity to myeloma cell triggers T-cell activity 2Myeloma cellkilled by T-cell3HCP Perceptions of BCMA-Directed Modalities Quotes from
191、Market Research*Clinically,its a decent response.But compared to these other BCMAs its a lot lower.US Hem/OncNot everyone is going to be a candidate for CAR-T,its kind of like transplant.Some of it is performance status and some of it is willingness to travel.US Hem/OncIm excited about BsAbs.Youre s
192、eeing responses very quickly and they seem to be very durable as well.US Hem/OncADCCAR-TBsAb55Near-Term Launches High-Value Pipeline Day|MagnetisMM-31Patient Population(n=187)EMD=extramedullary disease;BCMA=B-cell maturation antigen;TCE=triple class exposed;ECOG=Eastern Cooperative Oncology Group.aR
193、efers to patients previously treated with at least 2 PIs,2 IMiDs,and 1 anti-CD38 mAb.bHigh-risk cytogenic disease is associated with the presence of any of the following chromosomal abnormalities:t(4;14),t(14;16),and/or del(17p).cExtramedullary disease was defined as presence of any plasmacytoma(ext
194、ramedullary and/or paramedullary)with a soft-tissue component.dPrior BCMA-directed therapies included CAR T-cells or ADC therapies.References:1.Data on file.2.Mateos MV,et al.Leukemia.2022;36:13711376.Elranatamab Overview:Evaluated in a Broad,Heavily Pre-treated Patient Population,Representative of
195、Those with Highest Unmet NeedElranatamabElranatamab-OverviewPenta-drug refractorya45.5%(85)EMDc39.6%(74)34.2%(64)Prior BCMA-therapy exposeddAdditional Characteristics1in 2High-Risk CytogenicsbECOG Performance StatusPrevious Treatment HistoryDisease BurdenRenal FunctionReal World TCE Population2Prior
196、 BCMAPenta-drug refractorya17.7%EMD13.3%2.8%Prior BCMA-therapy exposedd1in 6Prior BCMA56Near-Term Launches High-Value Pipeline Day|4%26%47%22%US HCPsn=104Not at all Impressed23Neutral56Extremely ImpressedMagnetisMM-3 Data Presented at ASH 2022(Dec.10,2022)Ph2:Cohort A(n=123)non-BCMA Exposed,10.4 Mos
197、 Follow Up(October 14,2022 Cut Off)Elranatamab:Opportunity to Be a Leader in the BCMA BsAb ClassTransformative Potential in an Area of High Unmet NeedBCMA=B-cell maturation antigen;BsAb=bispecific antibody;ASH=American Society of Hematology;CRS=cytokine release syndrome;HCP=healthcare provider;SQ=su
198、bcutaneous;Q2W=once every 2 weeks;ORR=objective response rate.*Dosing protocol in MagnetisMM-3 and MagnetisMM-5 for monotherapy useSource:MagnetisMM-3 Oral;Elranatamab US Quantitative Message Testing Research,November 2022ElranatamabElranatamab-Commercial ApproachEarly and Deep ResponsesORR61%Probab
199、ility of Maintaining Response at 9 mos84%70%of Surveyed HCPs Were Highly Impressed with Elranatamab ProfileTop 2 BoxManageable Safety ProfileDosing ConvenienceCRS(all Gr1/2)56%Gr3 CRS0 Off-the-shelf Subcutaneous Q2W after W24*Flat DoseOverall HCP Reaction to Elranatamab Data57Near-Term Launches High
200、-Value Pipeline Day|Elranatamab Market Potential:Patient Impact Expected to Build Over TimePotential PeakRevenue$4B+BCMA BsAb Class Potential to Capture 40%-80%Market Share,with Elranatamab 1st or 2nd in ClassBCMA=B-cell maturation antigen;BsAb=bispecific antibody;RRMM=relapsed or refractory multipl
201、e myeloma;TCE=triple class exposed;DCE=double class exposed;NDMM=newly diagnosed multiple myeloma.Note:Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply.ElranatamabElranatamab Marke
202、t PotentialMagnetisMM-3:Ph2MagnetisMM-5:Ph3MagnetisMM-6:Ph3MagnetisMM-7:Ph3MagnetisMM-1MagnetisMM-2Expanded Eligibility and Duration of Therapy Expected as Elranatamab Moves Into Earlier Lines of TherapyMagnetisMM-9MagnetisMM-8MagnetisMM-4Total Addressable Patient PopulationRRMM TCE(active,not recru
203、iting)RRMM DCE(recruiting)NDMM-Post-transplant Maintenance(recruiting)NDMM-Transplant Ineligible(recruiting)3k Patients(US+EU5)58TalzennaProstate Cancer(PC)Suneet VarmaGlobal Oncology&US PresidentDecember 12,202259Near-Term Launches High-Value Pipeline Day|2nd Most Common Cancer in Men and 5th Most
204、Common Cause of Death in Men Worldwide1.Metastatic Prostate Cancer is Associated with a Relative 5-year Survival Rate of Only 31%21.Prostate Cancer Statistics.World Research Fund International.https:/www.wcrf.org/cancer-trends/prostate-cancer-statistics.Accessed 11-09-2022.2.American Cancer Society.
205、Survival rates for prostate cancer.Accessed July 30,2021.https:/www.cancer.org/cancer/prostatecancer/detection-diagnosis-staging/survivalrates.html.3.Rawla P.Epidemiology of Prostate Cancer.World J Oncol.2019 Apr;10(2):63-89.doi:10.14740/wjon1191.Epub 2019 Apr 20.PMID:31068988;PMCID:PMC6497009.4.IQV
206、IA LAAD dataset;payer mix time period is 2020-10 to 2021-09;product basket includes Xtandi and Zytiga/abiraterone across all indications5.Kirby M,et al.Int J Clin Pract.2011;11:1180-1192.6.American Cancer Society.Cancer Facts&Figures for African American/Black People 2022-2024.Atlanta:American Cance
207、r Society,2022.Disease Overview&Demographics:Prostate Cancer(PC)Talzenna inProstate CancerTalzenna-Disease&DemographicsWorldwideU.S.1020%of patients develop metastatic castration-resistant prostate cancer(mCRPC)within 5-7 years of diagnosis51.4 million new cases ofprostate cancer reported in 20201Av
208、erage age at diagnosis 65 years old3Black men are 2.1x more likelyto die from prostate cancerthan white men6270,000 new cases ofprostate cancer reported in 2020170%patients covered by Medicare460Near-Term Launches High-Value Pipeline Day|Prostate Cancer Disease Continuum:How the Disease Progresses1.
209、Kantar modified epidemiology2.Clarivate Decision Resources Group,20213.Internal analysis of Kantar modified epidemiologyDx:Diagnosed;mCRPC:metastatic castration-resistant prostate cancerDisease Progression to mCRPC is Associated with Poor OutcomesTalzenna inProstate CancerTalzenna-Disease&Demographi
210、cs2028 G7 Projected Treatment-eligible Patients and Projected Therapeutic Market Size1,261Near-Term Launches High-Value Pipeline Day|1.Cross-trial comparisons are not based on head-to-head studies and no direct comparisons can be madePARPi:Poly ADP-ribose polymerase inhibitor;HRR:homologous recombin
211、ation repair;rPFS:radiographic progression free survival;OS:overall survival;ORR:overall response rate;PSA:prostate specific antigen;mCRPC:metastatic castration-resistant prostate cancerTalzenna PC Overview:TALAPRO-2 is the First PARPi Combined with XTANDI to Demonstrate Clinical Benefit in mCRPC Pa
212、tients with or without HRR Gene MutationsTalzenna inProstate CancerTalzenna-Prostate Cancer Overview Achieved primary endpoint with statistically significant and clinically meaningful improvement in radiographic progress-free survival(rPFS)compared with placebo plus XTANDI results of primary endpoin
213、t exceeded the prespecified hazard ratio of 0.696 Trend toward improved overall survival(OS),key secondary endpoint still maturing Benefits for other secondary endpoints:Investigator assessed rPFS,ORR,PSA response,time to PSA progression rPFS appears to be the longest observed in a randomized trial
214、in this setting1 At the time of topline analysis,the safety of TALZENNA plus XTANDI were generally consistent with the known safety profile of each medicinePhase 3 study of TALZENNA(talazoparib),an oral poly ADP-ribose polymerase(PARP)inhibitor,in combination with XTANDI(enzalutamide)compared to pla
215、cebo plus XTANDI in men with metastatic castration-resistant prostate cancer(mCRPC),with or without homologous recombination repair(HRR)gene mutations62Near-Term Launches High-Value Pipeline Day|PARPi:Poly ADP-ribose polymerase inhibitor;ARi:Androgen receptor inhibitor;HRR:homologous recombination r
216、epair;OS:overall survival;ADT:androgen deprivation therapy;mCRPC:metastatic castration-resistant prostate cancer;nmCRPC:non metastatic castration-resistant prostate cancer;mCSPC:metastatic castration-sensitive prostate cancer*Subject to regulatory approval.TALAPRO-2 Demonstrates Compelling Data on t
217、he Use of PARPi+ARi Upfront Regardless of HRR Mutational StatusTalzenna inProstate CancerTalzenna-Prostate Cancer OverviewAndrogen receptor inhibitors(ARis)induce a phenotype resembling HRR deficiency and may increase sensitivity to PARP inhibitorsPotential Synergistic Impactof PARPi+ARi Combination
218、XTANDI has a distinct mechanismof action as it directly inhibits theAR receptorXTANDI does not require co-administration with prednisone and has demonstrated OS benefit in combination with ADT in nmCRPC,mCSPC and mCRPCPotentially 1stCombination to Market with XTANDI ARi Backbone*Potential to demonst
219、rate consistent effects across clinically relevant sub-populationsWith or without HRR gene mutationsPatients with prior abiraterone/docetaxel in mCSPC1L mCRPC All-comers Efficacy with Potential Consistent Effects63Near-Term Launches High-Value Pipeline Day|1.Cross-trial comparisons are not based on
220、head-to-head studies and no direct comparisons can be made 2.Subject to clinical trial and regulatory success,these PARPi+NHT combinations are all expected to launch within the next 12 months.DDR:DNA damage repair;NHT:novel hormonal therapies;AAP:abiraterone acetate plus predisone/predisolone;mCRPC:
221、metastatic castration-resistant prostate cancer;nmCRPC:non metastatic castration-resistant prostate cancer;mCSPC:metastatic castration-sensitive prostate cancer;BRCA1/2:Breast cancer gene 1,2;HRR:homologous recombination repair3.Note:Expected timing;all dates are preliminary,subject to change,and su
222、bject to,among other risks,assumptions and uncertainties,clinical trial and regulatory success and availability of supply.We Expect the TALAPRO-2 Combination to Compete with PROpel Combination in All-comers 1stLine mCRPC,if Approved1,2Talzenna inProstate CancerTalzenna-Competitive LandscapeTALAPRO-1
223、:Ph 2 talazoparib monotherapy in 2L+HRR-deficient mCRPC;Primary endpoint:ORR;Median rPFS 5.6 months;Median OS 16.4 months.Published in Feb 2021 in Journal of Clinical Oncology.TALAPRO-3:On-going Ph 3 talazoparib+enzalutamide vs.placebo+enzalutamide in HRR-deficient mCSPC;Primary endpoint:rPFS.PROpel
224、MAGNITUDETALAPRO-2Olaparib+abirateroneNiraparib+abirateroneTalazoparib+enzalutamideStudy PopulationAll-comers(N=796)(1)DDR positive(n=423)(2)DDR negative(n=233)(1)All-comers(2)DDR positiveAllowed Prior Treatment for mCSPC Docetaxel for mCSPC Taxane for mCSPC Any NHT(except AAP)in mCSPC 4 months AAP
225、for mCRPC Docetaxel for mCSPC Abiraterone for mCSPCStratification Factors Bone only vs visceral vs other Prior docetaxel/NHT in CSPC Prior taxane for mCSPC Prior NHT in nmCRPC or mCSPC Prior AAP for 1L mCRPC BRCA1/2 vs other HRR DDR status Prior docetaxel/NHT in CSPCExpected U.S.Order or Entry21st2n
226、d3rd64Near-Term Launches High-Value Pipeline Day|Large,Growing Advanced Prostate Cancer Therapeutics G7 Market Projected to Reach$31B,CAGR+12%11stLine Peak Year mCRPC AssumptionsG7 markets:US,Japan,Germany,Italy,France,Spain,UK1.Clarivate Decision Resources Group,20212.TALAPRO-3:On-going Ph 3 talazo
227、parib+enzalutamide vs.placebo+enzalutamide in HRR-deficient metastatic castration-sensitive prostate cancer;Primary endpoint:radiographic progression free survival.PARPi:Poly ADP-ribose polymerase inhibitor;NHT:novel hormonal therapy;PSMA:prostate-specific membrane antigen;AKTi:AKT inhibitor;mCRPC:m
228、etastatic castration-resistant prostate cancerTalzenna PC Market PotentialPARP Inhibitor+NHT Combinations are Uniquely Positioned to Drive Market Growth in Advanced Prostate CancerTalzenna inProstate CancerTalzenna-Market Potential in Prostate Cancer$14$2320222028Hormonal therapiesPARP inhibitorsChe
229、motherapyRadioligandsAKTi,Vx,OtherPARPi$0.7BPARPi$4.9B$31B$16BG7 Annual Diagnoses(Treatment Eligible)110-120KProjected Share of Annual Diagnoses12-25%Projected Duration of Therapy12-24 monthsExpectation of earlier NHT use with longer durations of therapy,earlier and broader use of PARPi combinations
230、2,and use of PSMA-targeted radioligandsPARPi CAGR+39%Potential PeakRevenue$1B+65Q&AKey Near-Term Launches66Andy SchmeltzSVP,Commercial Strategy&InnovationBreakthroughs that change patients lives Near-Term Launches High-Value Pipeline DayDecember 12,202267Near-Term Launches High-Value Pipeline Day|Fo
231、rward-Looking Statements,Non-GAAP Financial Information and Other NoticesFLSFLS Our discussions during Near-Term Launches+High-Value Pipeline Day includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from thos
232、e expressed or implied by such statements.We include forward-looking statements about,among other topics,our anticipated operating and financial performance;reorganizations;business plans,strategy and prospects;expectations for our product pipeline,in-line products and product candidates,including a
233、nticipated regulatory submissions,data read-outs,study starts,approvals,launches,clinical trial results and other developing data,revenue contribution and projections,pricing and reimbursement,potential market dynamics and size,growth,performance,timing of exclusivity and potential benefits;strategi
234、c reviews,capital allocation objectives,dividends and share repurchases;plans for and prospects of our acquisitions,dispositions and other business development activities;our ability to successfully capitalize on growth opportunities and prospects;manufacturing and product supply;our efforts to resp
235、ond to COVID-19,including our COVID-19 products;our expectations regarding the impact of COVID-19 on our business,operations and financial results;and other statements about our business,operations and financial results.Among other things,statements regarding revenue and earnings per share growth;th
236、e development or commercial potential of our product pipeline,in-line products,product candidates and additional indications or combinations,including expected clinical trial protocols,the timing of the initiation and progress of clinical trials and data read-outs from trials;the timing for the subm
237、ission of applications for and receipt of regulatory approvals;the timing of product launches;expected profile and labeling;potential revenue;expected breakthrough,best or first-in-class or blockbuster status or expected market entry of our medicines or vaccines;the regulatory landscape;and the comp
238、etitive landscape are forward-looking and are estimates that are subject to change and subject to clinical trial and regulatory success,availability of supply,competitive and market dynamics and other risks,assumptions and uncertainties.These statements may be affected by underlying assumptions that
239、 may prove inaccurate or incomplete,and are subject to unknown risks,uncertainties and other factors that may cause actual results to differ materially from past results,future plans and projected future results.As forward-looking statements involve significant risks and uncertainties,caution should
240、 be exercised against placing undue reliance on such statements.Additional information regarding these and other factors can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31,2021 and its subsequent reports on Form 10-Q,including in the sections thereof captioned“R
241、isk Factors”and“Forward-Looking Information and Factors That May Affect Future Results”,as well as in our subsequent reports on Form 8-K,all of which are filed with the U.S.Securities and Exchange Commission and available at www.sec.gov and .Potential risks and uncertainties also include global econ
242、omic and/or geopolitical instability,foreign exchange rate fluctuations and inflationary pressures and the impact of COVID-19 on our sales and operations,including impacts on employees,manufacturing,supply chain,marketing,research and development and clinical trials.The forward-looking statements in
243、 this presentation speak only as of the original date of this presentation and we undertake no obligation to update or revise any of these statements.Also,the discussions during Near-Term Launches+High-Value Pipeline Day may include certain financial measures that were not prepared in accordance wit
244、h U.S.generally accepted accounting principles(GAAP).Additional information regarding non-U.S.GAAP financial measures can be found in Pfizers Quarterly Report on Form 10-Q for quarterly period ending October 2,2022 filed with the SEC on November 9,2022.Any non-U.S.GAAP financial measures presented a
245、re not,and should not be viewed as,substitutes for financial measures required by U.S.GAAP,have no standardized meaning prescribed by U.S.GAAP and may not be comparable to the calculation of similar measures of other companies.Todays discussions and presentation are intended for the investor communi
246、ty only;they are not intended to promote the products referenced herein or otherwise influence healthcare prescribing decisions.Definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data as they may be confounded by various factors and should be interpreted with caution.
247、All trademarks in this presentation are the property of their respective owners.Paxlovid and emergency uses of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5),have not been approved or licensed by the FDA.Paxlovid has not been app
248、roved,but has been authorized for emergency use by the U.S.Food and Drug Administration(FDA)under an Emergency Use Authorization(EUA),for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients(12 years of age and older weighing at least 40 kg 88 lbs)with positive results of dire
249、ct SARS-CoV-2 viral testing,and who are at high-risk for progression to severe COVID-19,including hospitalization or death.Emergency uses of the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19,Bivalent have been authorized by the FDA under an EUA to prevent COVID-19 in individuals
250、aged 6 months and older.The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product during the COVID-19 pandemic under Section 564(b)(1)of the FFDCA unless the declaration is terminated or au
251、thorization revoked sooner.Please see the EUA Fact Sheets at and www.cvdvaccine-.68Near-Term Launches High-Value Pipeline Day|*For illustration purposes only and not intended to be to scale.All values at constant exchange rates.1Excludes 2022-2025 BD and 2022+Launches2Midpoint of expected negative L
252、OE impact of$16B-$18B from 2025-2030.3Risk-adjusted 2030 revenue goal from recent and new BD deals4Internal 2030 risk-adjusted revenue expectations for NME and new indications launches as shown on slide 6 Note:Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainti
253、es,clinical trial,regulatory and commercial success and availability of supply.Fortifying our Long-Term Growth PlansIntroductionIntroductionIllustrative*2025-2030 ProjectionsAt least$25B3$20B4$17B22025 BaselineRevenues12025-2030LOEsNew BD Deal 2030Risk-Adjusted Revenues2022 YTD&Next 18 Months Launch
254、es 2030 RevenuesAdditional Internal Pipeline Revenue through 20302030 RevenuesFocus of this discussion69Near-Term Launches High-Value Pipeline Day|Today We Will Focus On Select High-Value Programs inOur Robust Pipeline1IntroductionIntroductionInflammation&ImmunologyRitlecitinibEtrasimodDekavil1PF-06
255、480605(TNFSF15 Blocker)Ritlecitinib+/-zimlovisertib;Ritlecitinib+tofacitinibPF-06823859(interferon beta 1,IFBN1,Blocker)PF-07038124(Topical PDE4 inhibitor)RIST47211(CXCR2 antagonist)PF-06835375(anti-CXCR5)PF-07054894(CCR6 Antagonist)PF-07242813(CD1a inhibitor)PF-07295324(Topical Soft JAK Inhibitor)P
256、F-07275315(anti-IL4/13/TSLP)PF-07264660(Anti-IL4/13/33)InternalMedicineZavegepant(intranasal)ErvogastatErvogastat+clesacostatDanuglipronAPD418TemanogrelPonsegromabPF-070815321(GLP-1R Agonist)PF-07258669(MC4R Antagonist)OncologySomatrogonFidanacogene elaparvovecGiroctocogene fitelparvovecFordadistrog
257、ene movaparvovecMarstacimabInclacumabGBT021601(HbS polymerization inbitor)PF-06730512(Fusion protein containing SLIT ligand portion of ROBO2 receptor)ReciferceptPF-06755347(Immunomodulation)PF-07209326(Anti-E-selectin inhibitor)RareDiseaseVaccinesBNT162b2 bivalent(BA.4/BA.5)(COVID-19 Infection Boost
258、er U.S.;EU 12 years of age and older)2BNT162b2 bivalent(BA.1)(COVID-19 Infection Booster EU 12 years of age and older)2PF-06425090(Primary Clostridioidesdifficile infection)PF-06928316(Respiratory Syncytial Virus Infection(maternal)PF-06886992(Serogroups ABCWY Meningococcal Infections(adolescent and
259、 young adults)PF-07307405(Lyme disease)PF-07252220(mRNA influenza adults)PF-06842433(Invasive and Non-Invasive Pneumococcal infections(infants and children)PF-06760805(Invasive Group B Streptococcus Infection(maternal)PF-07845104(saRNA influenza adults)mRNAFlu+COVID combo2,3VZV mRNA2 for Shingles(pr
260、eclinical)Hospital(Anti-Infectives)PaxlovidAztreonam-avibactamFosmanogepixSisunatovirPF-07923567/RV-299(N-protein inhibitor)CTB+AVP(PF-07612577)(Beta Lactam/Beta Lactamase Inhibitor)PF-07817883(SARS-CoV-2 3CL protease inhibitor(oral COVID-19 treatment)Sasanlimab+Bacillus Calmette-GuerinARV-471Elrana
261、tamabPF-07901801(TTI-622)(CD47-SIRP Fusion Protein)PF-06647020(PTK7 Targeted Cytotoxicity)PF-06821497(EZH2 Inhibitor)PF-06873600(CDK 2,4,6 Inhibitor)PF-07062119(GUCY2c CD3 Bispecific Antibody)PF-06940434(Integrin alpha-V/beta-8 Antagonist)PF-07209960(interleukin 15 Activator)PF-07220060(CDK4 Inhibit
262、or)PF-07265807(AXL/MERTK Inhibitor)PF-07104091(CDK2 Inhibitor)PF-07248144(KAT6A Epigenetic modifier)PF-07284890(BRAF BP kinase Inhibitor)PF-07284892(SHP2 tyrosine phosphatase Inhibitor)PF-07257876(CD47xPDL1 Bispecific)PF-07263689(OBIR-2 Therapeutic)PF-07260437(B7H4-CD3 Bispecific)PF-07265028(HPK1 In
263、hibitor)PF-07104091+PF-07220060(CDK2+CDK4 inhibitors)PF-07799933 BRAF Class 2(BRAF Class 1 and Class 2 inhibitor)1.Pfizer pipeline snapshot as of November 1,2022;New Molecular Entities only,does not include Product Enhancements2.In collaboration with BioNTech3.Subject to reaching agreement with our
264、partnersNote:collaborations noted only for programs being highlighted todayRegistrationPhase 3Phase 2Phase 170Near-Term Launches High-Value Pipeline Day|High-Value Pipeline Section AgendaIntroductionIntroductionPipeline PresentationsSpeakersAnti-Interferon-beta(IFN-)Mike Corbo,Chief Development Offi
265、cer,Inflammation&ImmunologyAndy Schmeltz,SVP,Commercial Strategy&InnovationDanuglipron&PF-07081532Jim Rusnak,Chief Development Officer,Internal Medicine&HospitalAndy Schmeltz,SVP,Commercial Strategy&InnovationTTI-622Chris Boshoff,Chief Development Officer,Oncology&Rare DiseaseAndy Schmeltz,SVP,Comme
266、rcial Strategy&InnovationInclacumab&GBT-601Chris Boshoff,Chief Development Officer,Oncology&Rare DiseaseAndy Schmeltz,SVP,Commercial Strategy&InnovationmRNA Vaccines Flu,VZV,Flu/COVID comboAnnaliesa Anderson,Chief Scientific Officer,Vaccine Research&DevelopmentNavin Katyal,U.S.Commercial&Global Rese
267、arch Lead for mRNA Portfolio71Anti-Interferon-beta(IFN-)PF-06823859A Potential Breakthrough inDermatomyositis and PolymyositisMike CorboSVP,Chief Development Officer,Inflammation&ImmunologyAndy SchmeltzSVP,Commercial Strategy&InnovationDecember 12,202272Near-Term Launches High-Value Pipeline Day|A S
268、everely Debilitating and Life-threatening Specialty Rheumatology Indication1.Hopkinsmedicine.org;2.Claims data analysis 2017-2021;3.Findlay,Andrew R.;Goyal,Namita A.;Mozaffar,Tahseen(2015).An overview of polymyositis and dermatomyositis.Muscle&Nerve.51(5):638656 November 22,2022,3:36 PMDisease Overv
269、iew&Unmet Need:Dermatomyositis(DM)IFN-IFN-Dermatomyositis Disease OverviewSeverely debilitating&life-threatening disease affecting skin&muscle1Symptoms:inflammation,malaise,and muscle weakness;severe disease may have fibrotic organ involvement and significant decrease in physical function4060K cases
270、 in US2Associated with malignancy(13-24%);Decreased life expectancy3 10-year survival rate 62%1 branded immunoglobulin approved to treat DM,but high unmet need exists;Off-label options have limited efficacy&long-term toxicitiesHellotrope rashShawl signGottrons PaulesMuscleweaknessNail changes73Near-
271、Term Launches High-Value Pipeline Day|Homing in on a Driver of Disease Interferons:One of Many Immune Modulating CytokinesInhibiting IFN-is a Promising Novel Approach to Treating DermatomyositisIFN-IFN-Mechanism of ActionReduction in Body Weight After12-week TreatmentCytokines Are Made by Many Cells
272、 and Signal Through the BodyMacrophageGranulocyteLymphocyteEndothelialcellsFibroblastMastcellCYTOKINEInterferons 3 major types of interferons with roles in immune regulation and viral response 17 Type 1 interferons Type 1 interferons are elevated in multiple autoimmune diseases IFN-is a Type 1 inter
273、feronInterferonsChemokinesInterleukinsImmunityInflammationHost Defense74Near-Term Launches High-Value Pipeline Day|Pfizer CTI Collaboration Explores Potential Treatment CandidateIFN=Interferon Beta;CTI=Centers for Therapeutic Innovation.CTI pursues breakthrough science at the earliest stages.Project
274、s usually commence when a Principle Investigator proposes a target that is ripe for mounting a drug discovery effort,and then progress collaboratively towards and into the clinic.Uncovering a Role for IFN-in DiseaseIFN-IFN-Mechanism of Action123IFN-is secreted by fibroblastsIFN-binds to the interfer
275、on receptor on cellsActivation of immune response genes can be protective against infection or deleterious for autoimmune disease Researchers at Brigham and Womens Hospital and Harvard Medical School demonstrated a role for IFN-in dermatomyositis,a life threatening and debilitating autoimmune diseas
276、e Pfizer-made IFN-antibody potently and selectively blocks IFN-interaction with receptor on multiple cell types Does not block 16 other Type 1 IFNs,which retains the ability of Type 1 IFNs to fight viral infectionFibroblastIFN-IFN-ReceptorBiologyPfizer CTI Collaboration Delivers Treatment Candidate7
277、5Near-Term Launches High-Value Pipeline Day|Primary Efficacy Endpoint Met:Skin Disease Endpoint Target Value Exceeded1.Ahmed et al.,2020;IFN-=Interferon Beta;TEAEs=Treatment Emergent Adverse Events;2.The skin score=CDASIAnti-IFN-Has Breakthrough Potential for Dermatomyositis Based on a Successful Ph
278、ase 2 StudyIFN-IFN-Clinical dataChange in Skin Disease ScoreResponder Rates(%)Efficacy:Exceeded primary endpoint.Placebo-adjusted-13.7(150 mg)&-16.3(600 mg)change from baseline 80%of patients achieved a 40%change in skin disease score which corresponds to a meaningful quality of life improvement1 Sa
279、fety:Both doses were generally well tolerated Most common TEAEs were infections&infestations;3 mild cases of infection in Anti-IFN-group(N=30)vs 2 in placebo group(N=14)(no cases ofH.zoster or simplex)Change from BaselinePlaceboAnti-IFN-150 mgAnti-IFN-600 mg0-5-10-15-2014812Weeksp5%35.7%100%96.4%Ski
280、n Disease Decrease240%7.1%80%82.1%76Near-Term Launches High-Value Pipeline Day|Significant Differences Identified in Patient Reported Outcomes and Improvement ScoresIFN-=Interferon Beta;Muscle cohort was not sufficiently powered for efficacy evaluation;First potential approvals in DM±Preliminary
281、peak year sales in DM/JDM&PM,subject to changeAnti-IFN-Phase 2 Study Also Delivered Promising Data in Muscle Predominant CohortIFN-IFN-Clinical DataChange in Patient Global Assessment(PtGA)of MyositisChange in Creatine Kinase Muscle Damage Biomarker Efficacy:PtGA demonstrated a significant decreasin
282、g trend over time and a plateau was not observed after 12 weeks A significant change in creatine kinase was observed after 12 weeks;consistent with clinical improvement in muscle function Safety:600mg administered once monthly(total of 3 doses)was also generally well tolerated(consistent with skin s
283、afety data)p=0.0046WeeksChange from Baseline0-20-40-6014812-9.5-14.4-13.8-20.2-14.5-34.9-11.7-46.2WeeksChange from Baseline0-100-2004812-38-157.5-71-175.9-39.9-185.8p=0.028277Near-Term Launches High-Value Pipeline Day|Dermatomyositis(DM)&Polymyositis(PM)Overexpress Type 1 InterferonsLiao et al,Ann R
284、heum Dis.70:831;2011Scientific Justification for a Basket ApproachIFN-IFN-Dermatomyositis&PolymyositisIFN-inducible Genes Are Overexpressed in Both DM&PM Relative to Normal Muscle BiopsiesLowModerateHighIF127G1P3IF1T2LY6EOAS2OAS1IF144LIF144OAS3HERC5Mx1CMPK2IFIT1RSAD2RSAD2IFTT3ISG15EPST11OASLOASLIFTT
285、5IFTT5IF144XAF1XAF1DMPMNormal78Near-Term Launches High-Value Pipeline Day|Plan to Advance to Pivotal Development Concurrently in Dermatomyositis and Polymyositis Moving Anti-IFN-Forward to Phase 3IFN-IFN-Development PlanEfficacy signal observed in skin&muscle Safety profile:no pan-interferon safety
286、signalsAdvance to pivotal developmentTeams challenge:Can we pursue more indications?79Near-Term Launches High-Value Pipeline Day|A Severely Incapacitating Specialty Rheumatology Indication1.Claims data analysis 2017-2021;Disease Overview&Unmet Need:Polymyositis(PM)IFN-IFN-Polymyositis Disease Overvi
287、ewDefined by inflammation of the proximal musclesSymptoms:muscle weakness,typically symmetrical;Difficulty going up stairs,combing hair,and raising ones arms or headMay include arthritis,interstitial lung disease,and/or heart involvement(presenting as arrythmias)4060K cases in US1No approved targete
288、d treatments for Polymyositis.Commonly used therapies have limited efficacy and safety considerationsFeverRash(inconstant)Interstitial lung diseaseArthritis,Mechanics handsRaynaud phenomenonMysoitis80Near-Term Launches High-Value Pipeline Day|$6-12B Projected Advanced Therapy Category Spanning DM an
289、d PM(2030)1.2022 diagnosed population of 80-120K across DM and PM(claims data),growing through 2030 due to better diagnosis.2.85%of diagnosed patients expected to be treated,with 35-50%receiving advanced therapies(Pfizer market research 2021-2022).3.Preliminary assumption for average advanced therap
290、y price in a competitive DM treatment environment;4.assumption based on demand research in select ex-US countries as well as Rare Disease analoguesMarket Opportunity:Dermatomyositis(DM)and Polymyositis(PM)IFN-IFN-Market Opportunity2x4Potential US Total Addressable DM and PM Opportunity (2030,Project
291、ed)120-180K130-40%280%85%$150K3$36BU.S.Patients DiagnosedPrescribed Advanced TherapiesMarket Access for Advanced TxComplianceUS Opportunity SizeNet Annual Price$612BGlobal Opportunity Size81Near-Term Launches High-Value Pipeline Day|Opportunity to Potentially Contribute$1-3B in Peak Year SalesLT:lon
292、g-term,SOC:standard of care,IIM:idiopathic inflammatory myopathies1.Delayed diagnosis/misdiagnosis from Pfizer market research and literature.Projected growth in diagnosis based on I&I market analogues following approval of novel therapies;2.Pfizer market research 2021-2022;3.Preliminary scientific
293、and commercial feasibility being evaluatedNote:Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply.Commercial Potential:Anti-IFN-in Dermatomyositis and PolymyositisIFN-IFN-Commercial
294、PotentialProjected DM/PM MarketProjected Advanced Tx SharePotential Pfizer ShareNumber of diagnosed DM/PM patients projected to grow by up to 50%1Delayed diagnosis and misdiagnosis are common;opportunity to improve diagnosisAdvanced therapies expected to be prescribed to 30-40%of patients,who have i
295、nsufficient response or cannot tolerate available immunosuppressantsBased on physician demand research and consistent with other I&I diseases2Based on the Ph2 data IFN-is anticipated to be positioned to compete with a differentiated efficacy and safety profileAll DM/PMTherapies$6-12B$1-3BAdvancedThe
296、rapies ImmunoglobulinsAnti CD20Others e.g.cytokine inhibitors,complement inhibitors,IFN-Alpha/receptor 1 Anti IFN-82Near-Term Launches High-Value Pipeline Day|Note:Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial su
297、ccess and availability of supply.In Brief:Pfizers Anti-IFN-is a Potential Game-Changer for PatientsIFN-IFN-Summary Target a single pathway to achieve superior efficacy while avoiding pan-interferon safety signals Strong mechanistic fit could potentially translate into differentiated risk benefit pro
298、file vs approved and pipeline therapies1.Specialty rheumatology diseases with significant unmet need;few treatment options for patients2.New insights on drivers of these poorly-understood debilitating&life-threatening diseases3.Strong mechanistic support,with a successful Ph2 in Dermatomyositis4.Sci
299、entific rationale for a registrational enabling basket study in Dermatomyositis,Polymyositis5.Blockbuster commercial opportunity in multiple interferon-driven diseasesWe Are Excited About the Breakthrough Potential of Our Interferon-beta Antibody for Patients with Dermatomyositis and Polymyositis,fo
300、r Whom There Are Limited Treatment Options TodayA Compelling Value PropositionAnti-IFN-Potential:83PF-07081532&DanuglipronPotentially Best-in-Class Oral GLP-1RAJim RusnakSVP,Chief Development Officer,Internal Medicine&HospitalAndy SchmeltzSVP,Commercial Strategy&InnovationDecember 12,202284Near-Term
301、 Launches High-Value Pipeline Day|1.WHO:Obesity and overweight(https:/www.who.int/news-room/fact-sheets/detail/obesity-and-overweight),2022;2.World Obesity Atlas(https:/www.worldobesity.org/resources/resource-library/world-obesity-atlas-2022),2022;3.DRG 2020;4.Jastreboff,et al.Obesity as a Disease:T
302、he Obesity Society 2018 Position Statement.Obesity(Silver Spring).2019 Jan;27(1):7-9;5.International Diabetes Federation:IDF Diabetes Atlas 10th Ed.(https:/diabetesatlas.org/atlas/tenth-edition),2021;6.Carls,et al.Achievement of Glycated Hemoglobin Goals in the US Remains Unchanged Through 2014.Diab
303、etes Ther 8,863873(2017);CV=cardiovascular;HbA1c=hemoglobin A1c.Disease Overview&Unmet Need:Obesity and Type 2 DiabetesGLP-1Oral GLP-1RA-Disease Overview Chronic Medical Conditions That Can Lead to Serious CV,Metabolic and Other Health ConsequencesRising rates of obesity and diabetes carry significa
304、nt health consequencesGlobal Obesity Prevalence:650M1;1.025B2projected by 2030Low medical treatment rates3(200 chronic diseases4)for patients living with obesity Global Diabetes Prevalence:537M5;643M5projected by 2030 In the U.S.,only 50%of adults living with diabetes have HbA1c below treatment goal
305、685Near-Term Launches High-Value Pipeline Day|Class of Medicines Addresses Key Drivers of These DiseasesGLP-1=glucagon-like peptide 1GLP-1 Receptor Agonists Are Well-suited to Tackle Obesity and Type 2 DiabetesGLP-1Oral GLP-1RA-Mechanism of Action GLP-1RAs Shown to Have Effects on Weight Loss,Glycem
306、ic Control and Reduced CV RiskGLP-1 Receptor Agonists(GLP-1RAs)Decreased AppetiteDelayed Gastric EmptyingIncreased Insulin Secretion86Near-Term Launches High-Value Pipeline Day|Pfizer Innovation Delivers Full Agonist Investigational Oral GLP-1RAsPotent and Efficacious Small-molecule Agonists of the
307、GLP-1R,Differentiated by Full Agonist Biochemical ProfilesGriffith et al.J.Med.Chem.2022,65,12,82088226;t=elimination half-life;GLP-1RA=GLP-1 receptor agonist;characterization is based on available data comparing across trials;efficacy based on early-phase data efficacy profile to be confirmed in Ph
308、ase 3 trials GLP-1Oral GLP-1RA-DevelopmentSensitized Screening AssayEarly Activity in Screening AssayDevelopment of sensitized assay overcame challenges associated with identifying agonistsHigh-throughput screen of 2.8 million compounds and compound optimization progressed to clinical candidate danu
309、glipronDanuglipron Plasma ConcentrationPF-07081532 Plasma Concentrationt(4.3-5.7 hours)t(18-21 hours)Pfizers GLP-1RA Candidates:Only Oral Small Molecule Full GLP-1 Agonists Among Assets in DevelopmentTwo oral compounds with favorable characteristics and distincthalf-lives.No fasting restrictions.87N
310、ear-Term Launches High-Value Pipeline Day|Reduction in Body Weight After 12-week TreatmentDose-dependent Reductions in Both HbA1c and Body Weight in Patients with Type 2 Diabetes1.Gorman DN,Saxena AR,Frias J,Lopez RN,Tsamandouras N,Birnbaum MJ.Efficacy,safety and tolerability of danuglipron(PF-06882
311、961)over 12 weeks in Phase 2a study in adults with Type 2 diabetes mellitus.Abstract#588 presented at:Annual Meeting of the European Association for the Study of Diabetes,September 20,2022,Stockholm,Sweden.Dose range of 80-200 mg BID studied,not all doses shown;#Least squares mean;HbA1c=Hemoglobin A
312、1c;BID=twice a day;FPG=fasting plasma glucose;GLP-1=glucagon-like peptide 1Danuglipron:Potent Glycemic and Weight Loss Efficacy After 12 Weeks in Phase 2aGLP-1Oral GLP-1RA-Danuglipron-Clinical Data Phase 2a study in 123 adults with Type 2 diabetes treated with metformin,assessing tolerability of dan
313、uglipron(primary endpoint)and changes from baseline in HbA1c,FPG and body weight at Week 121 Safety profile consistent with GLP-1 class;most frequent Adverse Events were generally mild and GI-relatedDecrease in HbA1c After 12-week TreatmentHbA1c Reduction#(%)Danuglipron 200 mg BIDPlacebo-1.57-0.32Pa
314、rticipants Randomized to Danuglipron 200 mg BID(n=21)vs.Placebo(n=16)Bodyweight Reduction#(kg)Danuglipron 200 mg BIDPlacebo-5.4-0.488Near-Term Launches High-Value Pipeline Day|PF-07081532:A Once-daily Full Agonist with Dose-responsive ReductionsDose-dependent Reductions in Both Glucose and Body Weig
315、ht in Patients with T2D(and Body Weight in Patients with Obesity)After 4-6 Weeks in Phase 1b 1.Buckeridge C,Tsamandouras N,Carvajal-Gonzalez S,Brown LS,Chidsey KL,Saxena AR.Once-daily oral small molecule GLP-1R agonist PF-07081532 robustly reduces glucose and body weight within 4-6 weeks in a Phase
316、1b in adults with Type 2 diabetes and non-diabetic adults with obesity(EASD Abstract#114).Abstract#114 presented at:Annual Meeting of the European Association for the Study of Diabetes,September 21,2022,Stockholm,Sweden.Dose range of 10-180 mg QD studied,not all doses shown.*Posterior mean and 90%CI
317、(Bayesian Emax model);#Least squares mean;MDG=mean daily glucose;QD=once a day;FPG=fasting plasma glucose;HbA1c=Hemoglobin A1c;T2D=Type 2 diabetes;CI=confidence intervalGLP-1Oral GLP-1RA PF-07081532-Clinical DataReduction in Body Weight at 6 Weeks Phase 1b study in 51 adults with Type 2 diabetes and
318、 15 adults with obesity(without diabetes),assessing tolerability of PF-1532(primary endpoint)and changes from baseline in MDG,FPG,HbA1c and body weight at end of treatment1 Safety profile consistent with GLP-1 class;most frequent Adverse Events were generally mild and GI-relatedDecrease from Baselin
319、e in Mean Daily Glucose at 4-6 WeeksParticipants with Type 2 diabetes(n=51)Participants w/T2D at 6 weeks,PF-1532 180mg QD(n=8)vs.Placebo(n=2)-29.1-47.8-64.2-77.6-91.3-98.8-120-100-80-60-40-200Placebo10 mg30 mg60 mg120 mg180 mgChange from Baseline*Mean Daily Glucose(mg/dL)Bodyweight Reduction#(kg)-2.
320、1-5.1PlaceboPF-07081532 180 mg QD89Near-Term Launches High-Value Pipeline Day|GLP-1RA Clinical Development PlanPlan to Advance One Candidate to Phase 3(T2D&Obesity)Based on Efficacy,Tolerability and Dosing*Expanding to evaluate monthly titration schemes;GLP-1RA=GLP-1 receptor agonist;T2D=Type 2 diab
321、etes;HbA1c=hemoglobin A1cGLP-1Oral GLP-1RA-Clinical Development PlanPhase 2a(12-wk)study(T2D)NCT04617275Phase 2b(16-wk)study(T2D)NCT03985293Recently CompletedPhase 2b(32-wk)study*(Obesity)NCT04707313 anticipated completion 2H23OngoingPhase 1(4-6-wk)study(T2D&Obesity)NCT04305587Recently CompletedPhas
322、e 2b(32-wk)study(T2D&Obesity)NCT05579977 anticipated completion 1Q24(vs.oral semaglutide and placebo)Initiated DanuglipronPF-07081532Ongoing Phase 2b Studies Will Evaluate:Higher doses of PF-1532 to potentially drive greater dose-dependent reductions in blood sugar and body weight potentially exceed
323、ing currently approved GLP-1s Monthly titration of both candidates to allow patients to adjust to higher doses,with potential to minimize temporary GI side effectsPhase 2b study of PF-1532 will evaluate the safety and efficacy of once-daily doses of 20mg,40mg,80mg,160mg,and 260mg in patients with T2
324、D;and doses of 80mg,140mg,200mg,and 260mg in patients with Obesity compared with once-daily doses of oral semaglutide and placebo.Primary endpoints:placebo-adjusted change from baseline in HbA1c at Week 32 in T2D and placebo-adjusted percent change from baseline in body weight at Week 32 in Obesity.
325、90Near-Term Launches High-Value Pipeline Day|Market Opportunity:GLP-1RA$90B Projected GLP-1 Total Addressable Market Spanning Type 2 Diabetes and Obesity(2030,Based on Assumptions)Sources:Decision Resources Group,T2D and Obesity Market Forecast Assumptions,2022;Pfizer internal research 2021,2022;FT
326、Nov 22,Guggenheim Mar 22,Bernstein Jun 22GLP-1Oral GLP-1RA-Market OpportunityGLP-1RA Opportunity Type 2 Diabetes(2030,Projected)GLP-1RA Opportunity Obesity(2030,Projected)25-30MM100%25-30%65-70%$15-20$35-40BU.S.Patients Seeking TreatmentReimbursementGLP-1 Class ShareAdherenceMarket SizeNet Daily Pri
327、ce40-45MM50%50-60%45-55%$18-23$50-55BU.S.Patients Seeking TreatmentReimbursement(80%Commercial Plans)GLP-1 Class ShareAdherenceMarket SizeNet Daily Price91Near-Term Launches High-Value Pipeline Day|We believe Pfizers oral GLP-1s are well-positioned to compete on efficacy,tolerability and simplicity
328、of administration vs.other oral therapiesOrals projected to capture 30%of GLP-1 market by 2032 due to strong patient preference60%of patients prefer BID oral vs.QW injections$25B GLP-1 market currently growing at+30%per year,projected to reach$90B by 2030Danuglipron/PF-07081532 Commercial PotentialO
329、pportunity to Potentially Contribute$10B+in Peak Year SalesBID=twice a day;QW=once a week;Sources:T2D and Obesity Market Forecast Assumptions,2021,2022;Pfizer market research 2021,2022;FT Nov 22,Guggenheim Mar 22,Bernstein Jun 22Note:Preliminary,subject to change,and subject to,among other risks,ass
330、umptions and uncertainties,clinical trial,regulatory and commercial success and availability of supplyGLP-1Oral GLP-1RA-Commercial PotentialOral GLP-1RAs$90B$27B$10B(Potential)GLP-1RA Class92Near-Term Launches High-Value Pipeline Day|1.Pfizers sales forces ranked#1 across Core Specialties(2019-2021)
331、,which include Cardiologists,Primary Care(General Practice/Family Medicine/Doctors of Osteopathy)and OBGYNs.Estimate derived from the use of information under license from the following IQVIA information service:Sales Force Structures and Strategies for the period 2021-2022.(ref.:table 1-page 5 and
332、paragraph 1-page 7).IQVIA expressly reserves all rights,including rights of copying,distribution and republication;GLP-1 RA=GLP-1 receptor agonist;T2D=Type 2 diabetes;Potential best-in-class is based on cross-trial comparison,not on head-to-head data;Note:Preliminary,subject to change,and subject to
333、,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply.In Brief:Pfizers Oral GLP-1RA Candidates Are PotentialGame-changersGLP-1Oral GLP-1RA-SummaryWe Are Enthusiastic About the Promise of Pfizers Potentially Best-in-Class Oral Treatment Option for the Millions of Patients Living with T2D and ObesityA Compelling Value Proposition