Teva Pharmaceutical Industries Limited · TASE:TEVA
Teva Pharmaceutical Industries — Investor Day (September 2016)
66 slides from Teva Pharmaceutical Industries's investor day presentation, Sep 9, 2016
Slide 1: Global Generic Medicines
TevaTeva Pharmaceutical PharmaceuticalIndustries Industries Ltd. Global Generic Medicines September 9, 2016 1
Slide 2: Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This presentation contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future
Slide 3: Agenda
Agenda Opening — Erez Vigodman Intro Global Generics — Siggi Olafsson North America — Andy Boyer Europe — Dipankar Bhattacharjee Growth Markets — Erez Israeli Generic R&D — Hafrun Fridriksdottir Portfolio & Pipeline — Daniel Motto Wrap Up — Siggi Olafsson 3
Slide 4: Erez Vigodman
EREZ VIGODMAN President & CEO Teva Pharmaceutical Industries Ltd. 4
Slide 5: Siggi Olafsson - Global Generic Medicines
SIGGI OLAFSSON Global Generic Medicines 5
Slide 6: Teva Global Generic Medicines – by the numbers
Teva Global Generic Medicines – by the numbers $14-15 BILLION 16,500 80 MARKETS IN ANNUAL SALES NOT INCLUDING OTC EMPLOYEES WITH COMMERCIAL PRESENCE 16,000 TOP 3 LEADERSHIP POSITION IN OVER 100+ PRODUCTS * IN GLOBAL PORTFOLIO 40 MARKETS MARKETS WITH SALES EXPANSIVE PIPELINE WITH 1,500 120 BILLION >3
Slide 7: Teva Global Generic Medicines team
Teva Global Generic Medicines team Legacy Actavis SIGGI OLAFSSON President & CEO Global Generic Medicines Legacy Teva ANDY DIPANKAR EREZ VALUR HAFRUN DANIEL EDRIC HENRIETTE NIELSEN BOYER BHATTACHARJEE ISRAELI RAGNARSSON FRIDRIKSDOTTIR MOTTO ENGERT Chief North America Europe Growth Markets Medis Gene
Slide 8: Teva continues to lead the global generic market segment
Teva continues to lead the global generic market segment Global generic market share* 2015 (worldwide, % of SUs) Teva ~8% Novartis/ Sandoz 4.8% #1 position worldwide Sanofi/ Zentiva 3.0% by net sales and units Mylan 2.8% Sun Pharma 1.7% Significant gap to 2nd and Pfizer 1.3% 3rd tier players Lupin 1
Slide 9: Global Generics – a promising growth outlook
Global Generics – a promising growth outlook Generic sales by region, 2015-2020, $ Billions CAGR, 15-20’ 292 Percent 272 253 40 9% 236 37 220 34 206 31 28 109 10% China 26 99 82 90 Growth 75 69 Markets 6% 46 48 38 41 43 EU + Japan 36 79 82 86 90 94 5% US 75 2015 2016 2017 2018 2019 2020 SOURCE: IMS
Slide 10: Markets trends and unmet needs – favors generics for the long-term
Markets trends and unmet needs – favors generics for the long-term Urbanization Generic medicines are a key part of the solution to rising Governments struggle to healthcare costs deliver access to healthcare Manufacturing and Aging population development assets can be leveraged globally Changing mi
Slide 11: Teva's winning formula for Generics
Teva’s winning formula for Generics 1. Top market position in key markets –Selective on where we play, and then achieve or maintain critical scale 2. Broad, diversified portfolio and industry leading R&D delivering pipeline of new opportunities –A constant flow of new products refreshes the portfoli
Slide 12: Teva is best positioned to bring products from idea to market
Teva is best positioned to bring products from idea to market Active Distribution & Pharmaceutical R&D Operations Commercial Ingredients Pharmacies TAPI Development Manufacturing North America Wholesalers Clinical Supply Chain Europe Retailers Delivering Medicines Growth to Patients Hospitals Market
Slide 13: Teva's global footprint provides regional diversification
Teva’s global footprint provides regional diversification Global Generic Medicines 2016 Net Sales* Europe Top 3 position in 26 countries Established infrastructure and North America sales force - requires minimal incremental investment #1 generic market position in largest global market Broad portfo
Slide 14: Actavis Generics complements Teva's global reach
Actavis Generics complements Teva’s global reach Country split of Generics - Teva + Actavis New/expanded Strengthens Teva market Strengthens position presence Leverage pipeline position in key countries • US, Canada, Russia, UK New commercial presence in growth markets • Asia Pacific - Thailand, Sin
Slide 15: Focus on key growth drivers across each region
Focus on key growth drivers across each region • Continue leadership in first-to-files (FTFs) North America • Maximize flexibility from US-based manufacturing and R&D resources • Push the boundaries targeting complex products • Leverage existing infrastructure and maximize value from market positon
Slide 16: OTC complements our business
OTC complements our business Continues to be an appealing segment PGT Joint Venture Regional Brands US Private Label • PG + Teva resources • Legacy Actavis OTC • Teva + Actavis US OTC • Global branding • $200M - $300M Sales • Gx Mucinex (with Perrigo) • Top Brands: • Top products: • Confirmed first-
Slide 17: Biosimilars remain a strong fit within the Teva model
Biosimiliars remain a strong fit within the Teva model Best of both worlds Teva biologic/biosimilar Positioning Trade relations products today Branding, promotion Speed to market Market access Channel distribution GPO relations Medical Brand Teva Generic World Biosimilars World 17
Slide 18: Industry leading R&D capabilities and portfolio delivering industry leading results
Industry leading R&D capabilities and portfolio delivering industry leading results >2,000 new filings Achieved almost half of US globally in 2015 first-to-files in 2016 Internal CRO doses at least >500 active development one phase 1 study every day projects in the last 12 months 18
Slide 19: The largest and most competitive fully integrated manufacturing and supply chain network
The largest and most competitive fully integrated manufacturing and supply chain network in the industry… Iceland (1, 0) Netherlands (1, 0) Russia (1, 0) Ireland (3, 1) Serbia (1, 0) Canada (3, 0) Spain (1, 0) Czech (1, 1) Hungary (2, 2) UK (2, 0) Romania (1, 0) Poland (1, 0) Bulgaria (2, 0) Italy (
Slide 20: Pricing pressures in Generics
Pricing pressures in Generics Teva’s advantage: Generic price erosion • Price challenges are product specific - a broad diverse portfolio mitigates risk varies year-to-year • Strong understanding of the market Companies are • Offering differentiated products – lower impacted differently competition,
Slide 21: GDUFA goals at the FDA will benefit Teva's rich pipeline
GDUFA goals at the FDA will benefit Teva’s rich pipeline Teva has >300 files pending at the FDA Priority of First Generics majority are 1st - wave opportunities “For example, we consider “first generics” to be Teva FDA Filings public health priorities, as they can lead to increased patient access.….
Slide 22: Andy Boyer - North America
ANDY BOYER North America 22
Slide 23: Generics North America
Generics North America NA market space Teva’s position ~5% Generic retail market growth ~50% Ofbusiness global generics $80bn Generic sales retail net 18% US Market share with clear leadership ~38% Global Market Generic 300+ Filed products at the FDA >80% Generic penetration #1 Market position in US
Slide 24: Teva is the indisputable leader in the US Generics marketplace
Teva is the indisputable leader in the US Generics marketplace Teva 18% What does it mean to our customers? Mylan 10% • The broadest product portfolio covering 75% of US generic value Sandoz 7% • Strongest pipeline across therapeutic categories Pfizer 4% • Supply chain built to deliver superior serv
Slide 25: US purchasing power: Top customers represent >85% of retail market
US purchasing power: Top 4 customers represent >85% of retail market* Big-to-big relationships creates efficiency and win-win opportunities Per internal data 25
Slide 26: US market continues to evolve
US market continues to evolve Teva is well-positioned to succeed in any new market dynamic Market dynamics Teva’s position • Supply chain disruptions and increased FDA • Teva operations is a competitive advantage scrutiny and capable of creating additional value • GDUFA shortened review time and red
Slide 27: New US product launches – strong track record and even more compelling future
New US product launches – strong track record and even more compelling future New Product Launches 80+ Actual 68 65 Forecasted Expanded pipeline with 65 new 43 filings in 2015 35 >300 files pending at the FDA >100 confirmed first-to-files 2013 2014 2015 2016 2017 27
Slide 28: North America – looking forward
North America – looking forward • Combined two leading organizations that have all the ingredients required to grow and generate value • Broadest in-line portfolio with the most promising pipeline • Proven track record to maximize value of new product launches • Portfolio and customer relationships
Slide 29: Dipankar Bhattacharjee - Europe
DIPANKAR BHATTACHARJEE Europe 29
Slide 30: Generics Europe
Generics Europe Europe market space Teva’s position 2.5% Generics retail market growth ~25% Of global generics business $24bn Generics sales retail net ~14% Market share with clear leadership 500m+ People in Europe 272 Pipeline projects 2017 onwards Generics penetration Integrated 66% but varies acr
Slide 31: Teva Generics Europe
Teva Generics Europe Can create value if it has… Teva today • Advantages of scale and top ranking in the key • Top 3 market position in 26 Countries markets • Unparalleled customer reach via a Generic • A rich and balanced pipeline sales force of ~2300 • Ability to adapt commercial strategies to • F
Slide 32: Teva is the leader in Europe
Teva is the leader in Europe • Teva and Actavis combination very complementary from product and geographical perspective especially in Eastern Europe • Top position in largest EU generic pharma markets, leading to a top 3 generic position #1 in 26 countries Top 3 Top 5 • Addition of Actavis regional
Slide 33: Our commercial strategy adapts to markets for high profitability
Our commercial strategy adapts to markets for high profitability Europe net sales distribution by selling model Market type Example countries INN (molecule name): • United Kingdom • Sweden Products selected based on price • Netherlands • Norway level and supply reliability • Denmark 22% Sweden Pharm
Slide 34: The margin improvement is a result of a diligently executed transformation
The margin improvement is a result of a diligently executed transformation that will continue Europe Generics operating profit evolution How this was achieved • Maintain leadership • Focus on value through profitable growth rather +1000 bps than volume • Optimized portfolio with robust tail manageme
Slide 35: Key market highlights
Key market highlights UK Germany Italy Switzerland Bulgaria • #1 in the generics market • #2 in the generics market • #1 in the generics market • #1 in the generics market • #1 in the generics market • Offers the widest range of • ratiopharm leading brand • Double digit growth of • Double digit prof
Slide 36: Generics Europe – looking forward
Generics Europe – looking forward • Solidifying #1 position in Europe by increasing our share in highly profitable markets especially branded generics in Eastern Europe • Executing integration plans and maximizing cost and revenue synergies • Growing the Actavis brands in conjunction with existing T
Slide 37: Erez Israeli - Growth Markets
EREZ ISRAELI Growth Markets 37
Slide 38: Growth Markets
Growth Markets Growth Markets space Teva’s position 8.2% CAGR 2011-2015 ~25% Of global generics business 74% Spend on generics out of Rx market 26 Operating Countries 6bn People 1,194 Products pipeline in Integrated business 50% Of global GDP 3 lines (branded, generic, OTC) Per internal data and MAT
Slide 39: Substantial opportunities for growth
Substantial opportunities for growth Over $100bn incremental growth expected in Teva is well positioned to capitalize Growth Markets by 2020 • Urbanization – 70% of global • Established strong presence in selected megacities are in Growth Markets markets • Aging population – By 2050, older • Double
Slide 40: Leveraging global Teva brand and capabilities enable working in all business models
Leveraging global Teva brand and capabilities enable working in all business models Chile Indonesia Brazil Thailand S.Korea Peru Australia Japan Vietnam Hong Kong Mexico Russia Argentina Turkey Israel High out-of-pocket OOP and reimbursement High reimbursement Emerging Maturing Established Physician
Slide 41: Key market highlights
Key market highlights Russia Japan • #3 in the generic space • JV with Takeda established in April, brings strong brand and reputation • Broad portfolio of 775 products • Significant commercial presence including ~350 sales reps • #3 in market • Excellent relations with local • Combined portfolio of
Slide 42: Key market highlights
Key market highlights Latin America Active in the largest markets Looking forward Mexico - acquired Rimsa - strong • Leverage wide Teva-Actavis-Medis pipeline in player in private sector retail space Peru - #3 with strong commercial • Continue to build strong Teva brand to footprint in OTC and brand
Slide 43: Teva Growth Markets – looking forward
Teva Growth Markets – looking forward • Executing integration plans in Japan, Mexico and Actavis markets to maximize sale and cost synergies • Continue to build capabilities and competences at market level as response to market needs • Look for compelling inorganic moves in the biggest untapped oppo
Slide 44: Hafrun Fridriksdottir - Generics R&D
HAFRUN FRIDRIKSDOTTIR Generics R&D 44
Slide 45: Establishing a global Generic R&D powerhouse
Establishing a global Generic R&D powerhouse Combined two successful Generics R&D Teva’s Global Generics R&D organizations • Strong understanding of unique • 3000 employees requirements for generic development • 26 development sites • Ability to deliver on aggressive timelines critical to generics •
Slide 46: Teva Global Generic R&D network
Teva Global Generic R&D network Runcorn • UK Larne • Northern Ireland Pomona, NY • USA* Harlem • Netherland Ulm • Germany London • UK Elizabeth, NJ • USA Godollo & Debrecen • Hungary Hafnarfjordur • Iceland Parsippany, NJ • USA Bucharest • Romania • Ambernath, India Zagreb • Croatia Troyan • Bulgari
Slide 47: Teva & Actavis Development Complementary Capabilities
Teva & Actavis Development Complementary Capabilities Teva Actavis IR Oral Solids ER Oral Solids Semi-Solids & Liquids Combined Rings/Suppositories internal Transdermals development Injectables capabilities Complex Injectables have minimal Biologics/Biosimilars NA gaps
Slide 48: Teva already has a proven track-record on complex products
Teva already has a proven track-record on complex products Lidoderm Patch Nuvaring Ring Abraxane Inj Filed 2010 Filed 2013 Filed 2015 Exclusive FTF Excusive FTF Excusive FTF Suboxone Film Butrans Patch Forteo Inj Filed 2015 Excusive FTF Filed 2012 Filed 2013 Exclusive FTF Exclusive FTF and there is
Slide 49: Generic R&D 2015 performance
Generic R&D 2015 performance Country/Region Count United States 65 Europe (dossier completion) 65 65 new and existing dossiers resulted in around 1600 filings in Canada 22 2015 in European countries and Japan 17 other markets that accept Europe dossiers Russia 14 New Project Total 183 49
Slide 50: The US first-to-file performance was strong in 2015
The US first-to-file performance was strong in 2015 25 58 FTFs posted on FDA website in 2015 Exclusive FTF Shared FTF Exclusive + Shared FTF 20 11 11 4 6 5 10 4 4 4 4 4 7 5 1 <3 5 4 4 4 4 4 3 1 1 1 Teva Mylan Endo Fresenius Apotex Invagen Sun Prinston Zydus Others (22) Unknown* *Unknown: Generic fil
Slide 51: And the momentum has been maintained in 2016
And the momentum has been maintained in 2016 27 FTFs posted on FDA website As of September 7, 2016 13 Exclusive FTF Shared FTF 12 3 2 2 2 2 2 1 1 1 1 1 2 2 2 1 1 1 1 1 1 1 Teva Mylan Endo Sandoz Taro Hetero Lupin Micro Zydus Unknown* *Unknown: Generic filer not yet identified (not sued) Note: Total
Slide 52: Generic R&D – looking forward
Generic R&D – looking forward • Integration and optimization of the two R&D organizations • Execute against continuous flow of new product opportunities • Deliver on the high value products including complex products in respiratory, injectables, and other dosage forms • Keep up the momentum - contin
Slide 53: Daniel Motto - Portfolio Management
DANIEL MOTTO Portfolio Management 53
Slide 54: The outlook for new generic opportunities
The outlook for new generic opportunities The generic landscape • Innovative companies continue to bring new medicines to market • Patent challenges still bring value There is no shortage of • There are R&D synergies across regions, new generic product benefiting global generics companies opportunit
Slide 55: Teva today – the strongest pipeline in the company's history
Teva today – the strongest pipeline in the company’s history Where are we today? Well position to further expand the pipeline • More files pending regulatory review • Robust future product opportunities than ever before • Broad geographic coverage provides high • >500 products in active development
Slide 56: Our combined capacity and budget for new projects has increased
Our combined capacity and budget for new projects has increased Capacity for additional projects plus cost savings Illustrative Consolidation of overlap The synergies will allow us Overlap to target more products Non-overlap Actavis Teva 2017+ 2016 2016 56
Slide 57: We can leverage our generics pipeline across multiple markets
We can leverage our generics pipeline across multiple markets Volume of combined company across regions for specific oral solids 2015, % of SUs North America Europe Growth Markets Xeloda (Capecitabine) 24 Markets Abilify (Aripiprazole) 18 Markets Glucophage (Metformin) 29 Markets Nexium (Esomeprazol
Slide 58: Teva's US generic pipeline now exceeds 600 products
Teva’s US generic pipeline now exceeds 600 products 645 Sales value of targeted innovator products* 325 Filed products $110 Billion Confirmed Teva FTFs $52 Billion 320 Other products $58 Billion In development $90 Billion Targeted innovator sales $200 Billion Unique Products in Total US filings at F
Slide 59: Our global pipeline has expanded significantly in the last year
Our global pipeline has expanded significantly in the last year Balanced Portfolio: North Growth Europe Major products facing loss of America Markets • exclusivity (the must-haves) • Patent challenges to achieve early entry 2015 filings* 87 1260 240 • Local niche opportunities • Branded Generics Tot
Slide 60: Our patent challenge activity leads the industry
Our patent challenge activity leads the industry • > 90 active US Paragraph IV cases • 2015-2016 YTD activity • Product selection – 19 litigation wins Axiron (testosterone) • Development & filing Nuvaring (ee/etonogestrel) Beyaz (ee/drospirenone) • Patent litigation – 25 settlements Revlamid (lenoli
Slide 61: FDA 2016 posting of first-to-files: we lead in both number and value
FDA 2016 posting of first-to-files: we lead in both number and value By number of products By brand value $3.3B 88% Shared FTF Exclusive 14 $1B 27 48% $3.0bn 13 $2.8B Total Others Teva Total Teva Source: FDA Paragraph IV Certifications Website as of August 4, 2016, IPD Analytics and internal analysi
Slide 62: Our extensive pipeline provides many near-term launch opportunities
Our extensive pipeline provides many near-term launch opportunities 2016/2017 FTF Launch Opportunities and 30 Month Stay Expirations Ampyra® Neupro® Reyataz® Axiron® Nexium 24HR® OTC Safyral® Beyaz® Noxafil® Trokendi® 200mg Butrans® Nucynta® Tyvaso® >30 first-to-file launch Byetta® Nucynta ER® Uceri
Slide 63: And we are securing a robust pipeline for the future
And we are securing a robust pipeline for the future FTF Launch Opportunities and 30 Month Stay Expirations Confidential Settlements/ 2018 2019 and beyond Cases Dismissed Abraxane® Pazeo® Absorica® Osmoprep® Epiduo® Atripla® Abstral® Pradaxa® Adzenys XR-ODT® Picato® Pataday® Clindesse® Acanya® Oreni
Slide 64: Teva portfolio & pipeline – looking forward
Teva portfolio & pipeline – looking forward • Integration of our pipeline and in-market portfolio overlaps – Proceed ahead with the most advanced development programs – Switch to the most reliable, cost effective supply sources (internal & external) • Ongoing new product selection and revisit past ‘
Slide 65: Siggi Olafsson - Global Generic Medicines
SIGGI OLAFSSON Global Generic Medicines 65
Slide 66: Global Generic Medicines looking forward
Global Generic Medicines looking forward Expand Differentiated Pipeline Moves Integrations Top Line Launches Growth 66
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