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Teva-JPM-20240108 .pdf

1、Teva Pharmaceutical Industries Ltd.4242ndnd Annual Annual J.P.Morgan Healthcare J.P.Morgan Healthcare ConferenceConferenceJanuary 8,20242|This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995,which are based on managements cu

2、rrent beliefs and expectations and are subject to substantial risks and uncertainties,both known and unknown,that could cause our future results,performance or achievements to differ significantly from that expressed or implied by such forward-looking statements.Important factors that could cause or

3、 contribute to such differences include risks relating to:our ability to successfully compete in the marketplace,including:that we are substantially dependent on our generic products;concentration of our customer base and commercial alliances among our customers;delays in launches of new generic pro

4、ducts;the increase in the number of competitors targeting generic opportunities and seeking U.S.market exclusivity for generic versions of significant products;our ability to develop and commercialize biopharmaceutical products;competition for our innovative medicines;our ability to achieve expected

5、 results from investments in our product pipeline;our ability to develop and commercialize additional pharmaceutical products;our ability to successfully launch and execute our new Pivot to Growth strategy,including to expand our innovative and biosimilar medicines pipeline and profitably commercial

6、ize the innovative medicines and biosimilar portfolio,whether organically or through business development,and to sustain and focus our portfolio of generics medicines;and the effectiveness of our patents and other measures to protect our intellectual property rights,including any potential challenge

7、s to our Orange Book patent listings in the U.S.;our substantial indebtedness,which may limit our ability to incur additional indebtedness,engage in additional transactions or make new investments,may result in a further downgrade of our credit ratings;and our inability to raise debt or borrow funds

8、 in amounts or on terms that are favorable to us;our business and operations in general,including:the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto;the widespread outbreak of an illness or any other communicable disease,

9、or any other public health crisis;effectiveness of our optimization efforts;our ability to attract,hire,integrate and retain highly skilled personnel;manufacturing or quality control problems;interruptions in our supply chain;disruptions of information technology systems;breaches of our data securit

10、y;variations in intellectual property laws;challenges associated with conducting business globally,including political or economic instability,major hostilities or terrorism;costs and delays resulting from the extensive pharmaceutical regulation to which we are subject;the effects of reforms in heal

11、thcare regulation and reductions in pharmaceutical pricing,reimbursement and coverage;significant sales to a limited number of customers;our ability to successfully bid for suitable acquisition targets or licensing opportunities,or to consummate and integrate acquisitions;and our prospects and oppor

12、tunities for growth if we sell assets;compliance,regulatory and litigation matters,including:failure to comply with complex legal and regulatory environments;increased legal and regulatory action in connection with public concern over the abuse of opioid medications;our ability to timely make paymen

13、ts required under our nationwide opioids settlement agreement and provide our generic version of Narcan(naloxone hydrochloride nasal spray)in the amounts and at the times required under the terms of such agreement;scrutiny from competition and pricing authorities around the world,including our abili

14、ty to comply with and operate under our deferred prosecution agreement(DPA)with the U.S.Department of Justice(“DOJ”);potential liability for intellectual property right infringement;product liability claims;failure to comply with complex Medicare,Medicaid and other governmental programs reporting an

15、d payment obligations;compliance with anti-corruption,sanctions and trade control laws;environmental risks and the impact of Environmental,Social and Governance(“ESG”)issues;the impact of the state of war declared in Israel and the military activity in the region,including the risk of disruptions to

16、 our operations and facilities,such as our manufacturing and R&D facilities,located in Israel,the impact of our employees who are military reservists being called to active military duty,and the impact of the war on the economic,social and political stability of Israel;other financial and economic r

17、isks,including:our exposure to currency fluctuations and restrictions as well as credit risks;potential impairments of our long-lived assets;the impact of geopolitical conflicts including the state of war declared in Israel and the conflict between Russia and Ukraine;potential significant increases

18、in tax liabilities;and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits,or of a change in our business;and other factors discussed in our Quarterly Report on Form 10-Q for the quarter ended September 30,2023 and in our Annual Repo

19、rt on Form 10-K for the year ended December 31,2022(“Annual Report”),including in the sections captioned Risk Factors and“Forward-looking statements.”Forward-looking statements speak only as of the date on which they are made,and we assume no obligation to update or revise any forward-looking statem

20、ents or other information contained herein,whether as a result of new information,future events or otherwise.You are cautioned not to put undue reliance on these forward-looking statements.NonNon-GAAP Financial Measures GAAP Financial Measures This presentation includes certain non-GAAP financial me

21、asures as defined by SEC rules.Please see our press release reporting our financial results for the third quarter of 2023,as well as our Quarterly Report on Form 10-Q for the quarter ended September 30,2023,for a reconciliation of the non-GAAP financial measures to their nearest GAAP equivalents.Man

22、agement believes that such non-GAAP financial measures provide useful information to investors to facilitate their understanding of our business because the non-GAAP financial measures are used by Tevas management and board of directors,in conjunction with other performance metrics,to evaluate the o

23、perational performance of the company,to compare against the companys work plans and budgets,and ultimately to evaluate the performance of management;the companys annual budgets are prepared on a non-GAAP basis;and senior managements annual compensation is derived,in part,using these non-GAAP measur

24、es.Investors should consider the non-GAAP financial measures in addition to,and not as replacements for,or superior to,measures of financial performance prepared in accordance with GAAP.We are not providing forward looking guidance for GAAP reported financial measures or a quantitative reconciliatio

25、n of forward-looking non-GAAP financial measures to the most directly comparable GAAP measure because we are unable to predict with reasonable certainty the ultimate outcome of certain significant items including,but not limited to,the amortization of purchased intangible assets,legal settlements an

26、d loss contingencies,impairment of long-lived assets and goodwill impairment,without unreasonable effort.These items are uncertain,depend on various factors,and could be material to our results computed in accordance with GAAP.Revenues and CAPEX are presented on a GAAP basis.Some amounts in this pre

27、sentation may not add up due to rounding.All percentages have been calculated using unrounded amounts.President and Chief Executive Officer4|Where We Are TodayFrom historical negative topline evolutionLimited focus on our growth assets and pipelineFocused on debt repayment and settlement of litigati

28、onBack to revenue growthAUSTEDO is an established growth driver;Innovative pipeline externally recognized,in light of recent business development dealsOn track to meet financial commitments and reallocating capital to invest in growthPivot to Growth Strategy launched in May 2023 AUSTEDO-AUSTEDO XR l

29、aunched;on track to reach$1.2B 2023 target AJOVY sustained growth,on track to reach$400M 2023 target UZEDY launched in 2023 Generics back to revenue growth as of Sept.2023 Focused pipeline and portfolio 21 products,including 6 complex,approved in the U.S.in 2023 for an overall$14B brand value Teva A

30、PI Executing on standalone plan New CEO and management team appointedFocus our businessSustain genericspowerhouseDeliver on growth enginesStep up innovation 1.Accelerated from H1 25 for Ph3 results5|Late-stage pipeline Anti-TL1A collaboration with leading immunology player(Sanofi);and olanzapine LAI

31、 R&D funding agreement with Royalty Pharma Pipeline acceleration:olanzapine LAI Phase 3 results now expected in H2241;ICS/SABA first patient in Oct.23Building early-stage pipeline(anti-PD1/IL2,early-stage BD deal,etc.)Significant progress on all pillars6|Long-Term 2023 strategy execution On track to

32、 reach$1.2B 2023 sales target Launched improved profile with once-daily XR in May 2023Goal to achieve$2.5B revenue by 2027 across tardive dyskinesia and chorea associated with Huntingtons disease Launched in May 2023 Achieved initial Medicaid and hospital formulary approvals;expanding access across

33、all channels Establish a differentiated profile as a foundational therapy in Tevas schizophrenia portfolio#1 in new prescriptions for preventive anti-CGRP at a number of U.S.headache centers1 Improved market share year-over-year in the U.S.and EUContinue growing through geographic and market share e

34、xpansionSource:IQVIA based upon data from March 2023 through May 2023 at centers with 2 or more prescribers;50 or more new prescriptions for aCGRPs(March 2023 May 2023);and 900 or more total prescriptions for aCGRPs(March 2023 May 2023)7|$millions,U.S.revenues$millions,global revenuesJan.-Sept.2022J

35、an.-Sept.2023618817Jan.-Sept.2022Jan.-Sept.2023254314+32%+24%8|1.FDA inspection scheduled for January 24 2.U.S.BLA submission and/or EU MAA submissions.Note:All trademarks referenced are properties of their respective owners.Sources:Evaluate Pharma(2022),Internal AnalysisIn partnership with Alvotech

36、Proven capabilitiesGlobal commercial reachGenerated global revenue$1B through its biosimilar franchise since launchReference productBiosimilardevelopment status2022 U.S.originator brand net revenueGeographic scope2Filed1$19BFiled$6BPhase III$6BPhase III$4BPhase III$2BStrong late-stage pipelineMoving

37、 Ahead16 assets in pipeline for biosimilars with 5 products expected to launch by 2027Coverage of 68%of brand value of the top 20 productsPartnership model to optimize development costs and risks9|NeuroscienceRespiratoryImmunologyTherapeutic areas:Phase IPhase IIPhase IIIAnti-IL15(408)Celiac Disease

38、Anti-TL1A(574)IBD(UC/CD)LAI olanzapine(749)SchizophreniaAnti-PAR2(192)NeuroscienceICS/SABA(248)AsthmaAnle138b1(286)MSASelect assets as of November2023IBD:InflammatoryBowelDisease UC:UlcerativeColitis CD:Crohns DiseaseMSA:Multiple System Atrophy LAI:Long-Acting Injectable ICS:Inhaled CorticosteroidsS

39、ABA:Short-Acting Beta Agonist1.In collaboration with MODAG 10|Olanzapine LAI(TEV-749)ICS/SABA(TEV-248)Anti-TL1A(TEV-574)H2 2026 Phase III resultsH2 2024 Phase II interimH2 2024 Phase III resultsPotential to be first long-acting olanzapine with a favorable safety profilePotential to be first ICS/SABA

40、 for adult and paediatric indications,combining the two most widely used molecules1 Potential to be best-in-class for proven TL1A mechanism in UC/CD2Potential Market SizePotential Market Size3 3$4 4B B$2.52.5B B$2828B BProgress in Progress in 20232023Collaboration with Royalty PharmaPhase III recrui

41、tment finalized;read-out now expected in H2 24(vs.H1 25)First Patient in(Oct.23)Partnership with SanofiLAI:Long-Acting Injectable ICS:Inhaled Corticosteroids SABA:Short-Acting Beta Agonist UC:Ulcerative Colitis CD:Crohns Disease1.Fluticasone and Albuterol 2.De-risked mechanism given published data i

42、n anti-TL1A space 3.Olanzapine LAI,ICS/SABA-DRG Clarivate(2022),Anti-TL1A-Evaluate Pharma(Q2-2023)11|Financing and building our innovative pipelineSupporting our biosimilar partnership modelAntiAnti-TLTL1 1A A Maximizing asset value to Teva with pipeline-in-a-product potential 50/50 development cost

43、 and profit sharingUp to$Up to$1.51.5B B cashcashOlanzapine LAIOlanzapine LAI Royalty Pharma to provide R&D funding for the development of olanzapine LAI(TEV-749)Up to$Up to$125125M M R&D fundingR&D fundingEarlyEarly-stage dealstage deal Exclusive worldwide rights to develop and commercialize BD9 Mu

44、ltibody computationally designed as a dual specific antibody targeting IL-13/TSLP to treat Atopic Dermatitis and AsthmaUndisclosedUndisclosedBiosimilarsBiosimilars Expanded existing strategic partnership agreement to include two new biosimilar candidates and in-line extensions of two current candida

45、tes$4040M*M*Teva acquired subordinated convertible bonds,which were issued by Alvotech in Sept.2023,pursuant to a convertible bond instrument,dated December 20,202212|Making our Generics Business a Sustainable PowerhouseGlobal commercial footprint with focused portfolio Focused pipeline Optimized ne

46、twork and operational efficiency Concentrate on high value products and best-in-class service level Exit lowest contribution products High-value segments,U.S.and EU first to market,complex technologies including drug device combination,LAIs,etc.Move from 80%+of LOEs covered to 60%*Improve product la

47、unch performance Continued network optimization from 52 to 40-44 sites by 2027 Closed 3 sites in 2023 Operational excellence plan roll-out:COGS reduction and gross margin expansionLOE=Loss of exclusivity*Multi-year program with delivery spanning post 202713|Budesonide/Formoterol Fumarate pMDI(Symbic

48、ort)Fluticasone pMDI(Flovent)Octreotide(SandostatinLAR)Risperidone (Risperdal Consta)Teriparatide(Forteo)Octreotide(SandostatinLAR)Liraglutide(Victoza,Saxenda)Brinzolamide(Azopt)Dexmethasone(Dextenza)Respiratory InhalersLong-Acting InjectablesPeptidesOphthalmic Products Epinephrine Auto-Injector(Epi

49、pen)Naloxone Nasal Spray(Narcan)Etonorgestrel Implant(Nexplanon)Other technologiesSelect complex portfolio and pipeline productsApproved by FDA10New complex generic products approved in 22-2313Planned complex generic launches in 24-25,with a combined brand value of approximately$1010B BpMDI=Pressuri

50、sed Metered Dose Inhaler Trademarks mentioned are the property of their respective ownersHighly profitable business$85B merchant market for small molecules*Expected growth of 6-7%in the coming years*Strong market potentialTeva API best prepared to seize opportunityIndustry leading small molecule API

51、 portfolio 350 APIs in the portfolio,including complex moleculesLarge and diversified 3rd party customer base 1,000 customersDedicated platform and management teamNew CEO and management team to pilot standalone unit 14|*Source:Market reports(Technavio,Mordor Intelligence),broker reports,industry int

52、erviews,desk research15|16|Revenue growth(CAGR)Mid-single digitOperating income margin1,23030%Net debt/adjusted EBITDA22.02.0 x xCash-to-earnings2,3,4 8080%1.Operating income margin=Non-GAAP operating income divided by net revenues;excluding potential impact of BD depending on timing 2.All measures

53、including operating income,Adjusted EBITDA and cash-to-earnings are presented on a non-GAAP basis 3.Cash-to-earnings reflects free cash flow divided by non-GAAP net income attributable to ordinary shareholders 4.Free cash flow includes cash flow from operating activities,beneficial interest collecte

54、d in exchange for securitized accounts receivables,proceeds from divestitures of businesses and other assets,net of cash used for capital investment.17|Innovative launches(anti-TL1A,anti-PD1-IL2,anti-IL15)Sustainable innovative pipelineFocused business development Margin expansion Sustain growthInno

55、vative launches(olanzapine LAI,ICS/SABA)Biosimilars growthOptimized generics business Focused business development Margin expansion Accelerate growth AUSTEDO and AJOVY strong growth UZEDY launch Biosimilars launch Resource reallocation towards innovative Sustainable cash-generating from generics powerhouseReturn to growth-20272028+

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