Viatris Inc. · NASDAQ:VTRS
Viatris — Mylan — Investor Day (April 2018)
108 slides from Viatris's investor day presentation, Apr 11, 2018
Slide 1: 2018 Investor Day
Exhibit 99.1 | Built t Last 2018 Investor Day
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation includes “forward-looking statements.” Such forward-looking statements may include, without limitation, 2018 financial guidance, target leverage ratio, timelines for product launches and commercialization, planned submission dates, and any other statement
Slide 3: Our commitment to setting new standards in healthcare
At Mylan, We are committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we: Innovate to satisfy unmet needs Make reliability and service excellence a habit Do what’s right, not what’s easy Impact the future thr
Slide 4: Our Differentiated Business Model
Our Differentiated Business Model ACCESS is our core purpose. The more diversity we achieve through driving access, the more it enhances the DURABILITY of our business model. To drive access, Mylan has built tremendous DIVERSITY into our commercial, operational and scientific platforms.
Slide 5: Our Value Chain
Our Value Chain Live commitment to quality and safety Diversify revenue streams - no single product generates more than 4% of total revenue Develop and launch complex products Execute on strong scientific, regulatory, clinical, medical and legal IP capabilities Leverage sites with close proximity to
Slide 6: Access for the World's 7 Billion People
Access for the World’s 7 Billion People North America Europe Rest of World Scale across 35 European countries Portfolio of >1,500 distinct products Leadership: #1 by Gx volume and value in France; #2 by Gx volume and value in Italy; #3 by Gx volume in UK (est.) Key growth opportunities in China, Bra
Slide 7: Diversification Across Products, Markets and Channels
Diversification Across Products, Markets and Channels Products Markets Channels Access Gx Rx/Bx OTC Distribution Tender Substitution Prescription Hospital/ Institution E-Commerce Specialty Pharmacy Wholesaler/ Distributor Retail
Slide 8: Diversification Across Franchises
Diversification Across Franchises Current Products 2,000 Pipeline Products 400 700 100 350 400 1,250 200 400 200 60 30 700 150 400 50 500 150 800 700 >7,500 Products >2,500 Pipeline Products* Across many growing franchises, geographies, and businesses *Product is by product/dosage form/country basis
Slide 9: Diversification Across Geographies
Diversification Across Geographies Global NA Europe ROW $12.5B* U.S. Gx Ex-U.S. Gx Rx/Bx OTC OTC Rx/Bx Gx Rx/Bx Gx OTC Gx OTC Rx/Bx 2018E Total Revenues ~$5.0B ~$4.4B ~$3.1B *Represents the mid-point of the range of 2018 guidance
Slide 10: Mylan's Durability
Mylan’s Durability Durability Market type Product complexity Product mix Number of countries Product concentration Development (i.e. clinical trials) and manufacturing Rx/Bx, Gx, OTC no single product generates more than 4% of total revenue >165 countries and territories Market & channel type Cash F
Slide 11: Financial Performance: Consistent Execution on Commitments
Financial Performance: Consistent Execution on Commitments 11% CAGR(2) 15% CAGR(2) 13% CAGR(2) Adjusted EPS(1) Adjusted EBITDA(1) Total Revenues (1) Adjusted metrics are non-GAAP financial measures. Please see Appendix or investor.mylan.com for the most directly comparable U.S. GAAP financial measur
Slide 12: Strong and Consistent Cash Flow and ROIC
Strong and Consistent Cash Flow and Returns on Invested Capital (ROIC) 2014 – 2017 Average Adjusted metrics are non-GAAP financial measures. Please see Appendix or investor.mylan.com for the most directly comparable U.S. GAAP financial measures and reconciliations of such non-GAAP financial measures
Slide 13: Our Impact
Our Impact Doing Good Champion for access to medicine for almost 60 years Formalize and showcase our Global Social Responsibility commitments Stakeholder-focused company Doing Well Deliver consistent and reliable results for shareholders Significant financial strength and flexibility Continue to del
Slide 14: Our Objectives for Today
Our Objectives for Today Show how our durability is driving our future growth Share how our commitment to access is driving our diversification Demonstrate how diversification is driving our durability Highlight how our business model continues to deliver strong financial flexibility
Slide 15: Leadership Introductions
Leadership Introductions
Slide 16: Today's Presenters
Today’s Presenters Heather Bresch Chief Executive Officer Rajiv Malik President Ken Parks Chief Financial Officer Tony Mauro Chief Commercial Officer Abhijit Barve R&D Andrea Miller R&D Andrew Cuneo Rest of World Arnd Annweiler R&D Jacek Glinka Europe Patrick Vallano R&D Robert Tighe North America -
Slide 17: Durability of Our Platform
Durability of Our Platform
Slide 18: Overview
Overview Mylan durability Fueling growth in key markets Pipeline transparency Initiatives and growth areas
Slide 19: Diversified and Durable Platform Differentiates Our Ability to Deliver Growth
Diversified and Durable Platform Differentiates Our Ability to Deliver Growth >7,500 marketed products sold in >165 countries and territories No single product to generate more than 4% of total revenue Ample room for growth across Rx/Gx/OTC Cross pollination of products Growing presence in emerging
Slide 20: Scientific Execution and Deep Pipeline
Scientific Execution and Deep Pipeline Based on IQVIA MIDAS and NSP data for the 12 months ended 12/17 (brand value of Mylan’s pipeline + submissions pending approval). Cumulative spend refers to adjusted R&D. Adjusted metrics are non-GAAP financial measures. Please see appendix or investor.Mylan.co
Slide 21: Integrated Global Supply Chain
Injectables Oral Solid Dose Complex(2) API 24 7 7 9 >75B doses >500M units 1.3B units >4,800 KL Integrated Global Supply Chain Quality at the heart of everything we do Global network of 47 operations facilities(1) Broad range of dosage forms and capabilities Ample capacities to meet market needs and
Slide 22: Broad Portfolio Across Multiple Markets and Channels
Broad Portfolio Across Multiple Markets and Channels Rx: Physician prescribed and marketed mostly with a brand name Bx: Branded generics Gx: Unbranded generics OTC: Over-the-counter and consumer (Cx - physician endorsed) Distribution: Pharmacy chain and/or wholesaler are decision makers Tender: Publ
Slide 23: Broad Portfolio Across Multiple Markets and Channels
Broad Portfolio Across Multiple Markets and Channels Global supply chain Deep pipeline Diverse portfolio Vertical integration Cost of goods Quality at the core Multi-channel presence Global commercial footprint Success Factors Products Markets Channels Access Gx Rx/Bx OTC Distribution Tender Substit
Slide 24: Defining Durability
Defining Durability Durability Unique global commercial and operating platform Product complexity Product mix Number of countries Product concentration Development (i.e. clinical trials) and manufacturing Rx/Bx, Gx, OTC no single product generates more than 4% of total revenue >165 countries and ter
Slide 25: Broad and Deep Scientific Capabilities
Broad and Deep Scientific Capabilities
Slide 26: What It Takes To Be Successful
Broad development competencies Integrated device development and strategy Flexible and efficient clinical expertise What It Takes To Be Successful Manage complex technical partnerships Ability to scale up technology to support commercial manufacturing Understand global regulatory landscape and defin
Slide 27: Integrated Scientific Platform
Integrated Scientific Platform 2 24 x 7 >3,000 2 >50 2 10 >4,000 Global R&D centers Global R&D R&D, clinical, medical and regulatory professionals Markets with in-country regulatory expertise Complex analytics labs Dedicated central device labs Technology-focused development sites Across API, OSD, b
Slide 28: R&D – Investing to Increase Durability
R&D – Investing to Increase Durability Continued optimization of the pipeline Focus on complex products Critical assessment of ROI and time to market for core generics OSD Injectables API Biosimilars Complex injectables Respiratory Complex OSD Dermatology Key Brands Innovation Percentages based on 2
Slide 29: Robust Pipeline Opportunities
Robust Pipeline Opportunities Based on IQVIA MIDAS and NSP data for the 12 months ended 12/17 (brand value of Mylan’s pipeline + submissions pending approval). Excludes key brands and OTC pipeline Transdermal Delivery System Product pipeline is molecule plus form independent of market Products pendi
Slide 30: Cross-Pollinating Our Portfolio Across the Globe
Cross-Pollinating Our Portfolio Across the Globe Leveraging our portfolio Mylan Legacy Agila FamyCare Meda Renaissance Abbott/EPD >500 submissions* in 2017 across 70+ countries >550 additional submissions * planned in 2018 ~200 additional products under evaluation for submission in 2018 or 2019 Driv
Slide 31: Significant Expansion in Our Global Pipeline
Significant Expansion in Our Global Pipeline North America Europe Japan, Australia and New Zealand Emerging markets 359 products in pipeline 267 products pending approval 174 products in pipeline 528 products pending approval 181 products in pipeline 41 products pending approval 310 products in pipe
Slide 32: Key Pipeline Updates
Key Pipeline Updates
Slide 33: Continuing to Shape Our Broad Biosimilars Pipeline
Continuing to Shape Our Broad Biosimilars Pipeline Consider opportunity, geography and market formation Focus on complementary capabilities Continuously review opportunities to accelerate market entry Continuously evaluate portfolio and prioritize data, regulatory insights and market dynamics Partne
Slide 34: Continued Progress on Biosimilar Programs (Mylan/Biocon)
Biosimilar Therapeutic Area Cell Line Process Development Preclinical PK/PD (Phase 1) Confirmatory Clinical (Phase 3) BLA/MAA Approval Pegfilgrastim (Neulasta®) Oncology Trastuzumab (Herceptin®) Oncology Bevacizumab (Avastin®) Oncology Insulin Glargine (Lantus®) Diabetes Adalimumab (Humira®) Autoimm
Slide 35: Continued Progress on Biosimilar Programs (Mylan/Momenta)
Continued Progress on Biosimilar Programs Biosimilar Therapeutic Area Cell Line Process Development Preclinical PK/PD (Phase 1) Confirmatory Clinical (Phase 3) BLA/MAA Approval Abatacept (Orencia®) Autoimmune Aflibercept (Eylea®) Ophthalmology M3 Undisclosed M4 Undisclosed M5 Undisclosed M6 Undisclo
Slide 36: Continued Progress on Biosimilar Programs
Mylan/FKB Mylan/Mabion Mylan/Revance Mylan/CKD Continued Progress on Biosimilar Programs Biosimilar Therapeutic Area Cell Line Process Development Preclinical PK/PD (Phase 1) Confirmatory Clinical (Phase 3) BLA/MAA Approval Adalimumab (Humira®) Autoimmune Rituximab (Rituxan®/ Mabthera®) Oncology/ Au
Slide 37: One of the Most Comprehensive Biosimilar Programs
Mylan/FKB One of the Most Comprehensive Biosimilar Programs Biosimilar Therapeutic Area Cell Line Process Development Preclinical PK/PD (Phase 1) Confirmatory Clinical (Phase 3) BLA/MAA Approval Pegfilgrastim (Neulasta®) Oncology Trastuzumab (Herceptin®) Oncology Bevacizumab (Avastin®) Oncology Insu
Slide 38: Increasing Access for Trastuzumab Globally
Increasing Access for Trastuzumab Globally Mylan’s trastuzumab is the first U.S. biosimilar trastuzumab to Herceptin approved by FDA (December 2017) Validated science Regulatory execution Mylan’s trastuzumab approved by FDA in U.S. and ANVISA in Brazil Health Canada approvable obtained 24 total appr
Slide 39: Getting Ready for Pegfilgrastim Commercialization
Getting Ready for Pegfilgrastim Commercialization Geographic expansion >30 pending approval >50 scheduled submissions June 4, 2018 FDA action date EU regulatory review progressing well Strong data supporting biosimilarity Analytical similarity PK with EU and U.S. sourced brand Phase 3 equivalence in
Slide 40: Increasing Access to Insulin Glargine (Lantus) Globally
Increasing Access to Insulin Glargine (Lantus) Globally Geographic expansion Approved in 38 markets >20 pending approval >30 scheduled submissions U.S.: substitutability Vial and disposable pen presentations under active FDA review Planned launch in 2020 EU approval achieved EC approved Semglee Plan
Slide 41: Global Program Built on Solid Science
Global Program Built on Solid Science Lantus -> MIG MIG -> Lantus Lantus -> MIG Pharmacodynamic Pharmacokinetic Phase 3: Type 1 Diabetes HbA1c Switching between Mylan’s insulin glargine and Lantus did not affect efficacy, safety, and immunogenicity Foundation to support substitutability in U.S. mark
Slide 42: Positioning Adalimumab for Approval and Commercialization in Europe
Positioning Adalimumab for Approval and Commercialization Around Market Formation in Europe EU regulatory review progressing well Expect 2H 2018 EMA decision Strong scientific basis for biosimilarity Analytical similarity with Humira PK with EU and U.S. sourced brand Phase 3 equivalence in RA with t
Slide 43: Further Highlights on Biosimilar Pipeline
Further Highlights on Biosimilar Pipeline Aflibercept M710 Insulin Aspart Bevacizumab Recent Additions Biosimilar to Eylea Biosimilar to Novolog Biosimilar to Avastin Biosimilars to Toujeo and Perjeta Commercial manufacturing scale achieved Promising analytical similarity data Start-up activities fo
Slide 44: Respiratory
Respiratory
Slide 45: Preparing for U.S. Launch: Wixela Inhub
Preparing for U.S. Launch: Wixela™ Inhub™ Potential opportunity for extended sole generic Target action date of June 27, 2018 Commercial manufacturing site in Dublin built, qualified and prepared for launch Seeking approval for substitutable generic to GSK Advair® Diskus® Increase access and afforda
Slide 46: Advancing Gx Symbicort pMDI in Collaboration with 3M
Advancing Gx Symbicort® pMDI (U.S.) in Collaboration with 3M Product development status Pivotal PK studies were positive and demonstrated BE for both product strengths In vitro equivalence data are positive for both product strengths Clinical equivalence study - headline results positive with clinic
Slide 47: New Potential Opportunity for COPD Patients: Revefenacin
(N=92) (N=89) New Potential Opportunity for COPD Patients: Revefenacin (U.S.) Significant and clinically meaningful improvements demonstrated in clinical program over placebo Seeking once-daily dosing Potential to be used in any approved standard jet nebulizer Proposed long acting, once-daily nebuli
Slide 48: Complex Sterile Products and Device Development
Complex Sterile Products and Device Development
Slide 49: Commitment to Complex Sterile Products
Commitment to Complex Sterile Products ~$28B target global market* Natural extension of our scientific capabilities and focus Complexities Significant investment Challenging science Excipient/API Complex analytics tools Therapeutic equivalence demonstration Patent landscape Diverse regulatory hurdle
Slide 50: Key Complex Sterile Products Pipeline
Product Brand Reference Reverse Engineered API/Sourcing Excipient Q1/Q2 Confirmed Formulation/ Development Registration/ Exhibit/Clinical Batches Clinical Submission Cyclosporine Restasis® Cyclosporine multiple-dose Restasis® MultiDose Medroxyprogesterone Depo-Provera® Enoxaparin PFS Enoxaparin® Glu
Slide 51: Cyclosporine Ophthalmic Emulsion (Restasis)
Cyclosporine Ophthalmic Emulsion (Restasis) Single-dose vials – pending approval Submitted November 20, 2013 All Citizen Petitions addressed by FDA Meet all requirements of the BE Guidances Legal Asserted patent claims found invalid by district court; appeal pending IPR stayed pending oral argument
Slide 52: Integrated Drug/Device Development Strategy
Integrated Drug/Device Development Strategy 150+ drug/devices in development 2 Mylan platform devices Our unique capabilities Complexities and requirements FDA: increased focus on the device constituent part of a drug-device combination product 21 CFR Part 4 Guidance on GMPs for Combination Products
Slide 53: Global Key Brands
Global Key Brands
Slide 54: Investing in Our Global Key Brands
Contributing to growth in existing brands across the markets Investing in Our Global Key Brands Unique Features Patient support through digital tools New formulations and indications Scientific evidence of value to prescribers and patients Geographic expansion Providing scientific insights, awarenes
Slide 55: Investing in Dymista: Scientific Insights and Geo-expansion
New scientific evidence Fast onset of action of 5 minutes demonstrated Chamber study evaluated nasal and ocular symptoms compared to combination of intranasal fluticasone and oral anti-histamine Dymista’s 5-minute onset of action significantly faster than comparator (120-150 minutes) Development for
Slide 56: Enhancing Creon: New Strengths and Geographic Expansion
Complex biological product for treatment of pancreatic exocrine insufficiency (PEI) Enhancing Creon: New Strengths and Geographic Expansion Durable product *Co-development with Abbott Additional opportunity to grow the brand via life cycle management New strengths* (20,000 and 35,000 lipase units) d
Slide 57: Investing in Influvac: New Strains and Indications
Investing in Influvac: New Strains and Indications Influvac Tetra (quadrivalent vaccine)* Comprehensive clinical program completed across more than 2,000 subjects Approved in 2017 and registered for adults/elderly in 21 EU countries, Australia and New Zealand Study in pediatrics (3-17 years old) suc
Slide 58: New Pipeline Opportunities and Innovation
New Pipeline Opportunities and Innovation
Slide 59: Glatiramer Acetate Once-Monthly Depot Injection
Glatiramer Acetate (GA) Once-Monthly Depot Injection Partnership with Mapi Pharma Scientific expertise with long-acting depot injection formulations Target once-monthly IM injection Treatment of patients with RRMS Planned 505(b)(2) submission to FDA Global market rights $24B Relapsing-Remitting Mult
Slide 60: Compelling Biosimilar BOTOX Commercial Opportunity
Compelling Biosimilar BOTOX Commercial Opportunity $4B* global market ~55% Therapeutic* ~45% Aesthetics* Reimbursed Cash pay Critical mass in the Dermatology franchise to address both therapeutic and aesthetic areas Robust portfolio of both topical and systemic products spanning multiple therapeutic
Slide 61: Our Confidence for Biosimilarity
Our Confidence for Biosimilarity Parameter Mylan/Revance (Biosimilar of BOTOX) Allergan (BOTOX) Ipsen (Dysport®) Merz (Xeomin®) Drug Substance ~900 kDa (150 kDa Toxin + ~750 kDa NTHA and HA complex) ~900 kDa (150 kDa Toxin + ~750 kDa NTHA and HA complex1) ~400 kDa (150 kDa Toxin + ~250 kDa NTHA and
Slide 62: Conjugated Estrogens (Gx Premarin)
Conjugated Estrogens (Gx Premarin®) FDA Draft Guidance Requirements December 2014 Sameness of API Multifaceted chromatographic techniques using methods defined by USP and FDA Characterization of multiple lots of RLD Qualitative and quantitative equivalence of steroidal and non-steroidal components M
Slide 63: Meloxicam: Fast-Acting, Novel Delivery Non-Opioid Option
Meloxicam Fast-Acting, Novel Delivery of Non-Opioid Option for Patients Licensed from Prayog Labs LLC Global development and market rights Fast on-set of action of a known and trusted drug Targeting treatment of both chronic and acute pain Potential to replace opioids in the treatment of acute pain
Slide 64: Potential Global Pipeline (Investor Day 2017)
Potential Global Pipeline (Investor Day 2017)
Slide 65: Deep Global Pipeline With a Focus on Execution
Deep Global Pipeline With a Focus on Execution Pending Approved In Development/Announced Program Potential Opportunity All product names are property of their respective owners.
Slide 66: Update on Other Key Initiatives
Update on Other Key Initiatives
Slide 67: Other Key Initiative Highlights
Other Key Initiative Highlights Infectious Disease Dermatology Injectables OTC Build upon our strong capabilities in ARVs in the developing world through: R&D focus Manufacturing scale Supply chain Partnerships and customer relationships Industry engagement Grow and expand ARV presence in Europe and
Slide 68: Durability and Diversification in Our Markets
Durability and Diversification in Our Markets
Slide 69: Diversification Across Geographies
Diversification Across Geographies Partner of choice for our customers Global NA Europe ROW $12.5B* U.S. Gx Ex-U.S. Gx Rx/Bx OTC OTC Rx/Bx Gx Rx/Bx Gx OTC Gx OTC Rx/Bx 2018E Total Revenues *Represents the mid-point of the range of 2018 guidance ~$5.0B ~$4.4B ~$3.1B
Slide 70: Diversity + Complexity + Scale = Global Durability
Product complexity Market & channel type Product mix Number of countries Product concentration Development (i.e. clinical trials) and manufacturing Rx/Bx, Gx, OTC no single product generates more than 4% of total revenue >165 countries and territories Diversity + Complexity + Scale = Global Durabili
Slide 71: Europe
Europe
Slide 72: Europe – A Diversified Platform
Europe – A Diversified Platform Scale across 35 European countries No single product greater than 4.5% of European Net Sales Cover all major therapeutic areas with many leading brands(1) Portfolio of >1,500 distinct branded, generic and OTC products Most of the top European markets are outpacing mar
Slide 73: Growth Opportunities Across Europe
Growth Opportunities Across Europe Rx/Bx Gx OTC Maximize biosimilar launches including adalimumab, trastuzumab, pegfilgrastim and insulin glargine Reinvigorate tender market participation Expand injectables and ARV portfolios Build out hospital business across European countries Increase utilization
Slide 74: Europe – Expanding Leadership and Cultivating Opportunity
Europe – Expanding Leadership and Cultivating Opportunity France $33B Italy $29B Germany $45B U.K. $26B #1 #1 #1 #3 #2 #2 #4 #13 #10 #8 #9 #28 #3(3) Prescription Value (2) Gx Market Volume(2) Gx Market Value (2) Prescription Volume (2) Prescription Market Value(1) 2018E Third-Party Net Sales MARKET
Slide 75: Rest of World
Rest of World
Slide 76: ROW - Exciting Opportunities for Long-Term Growth
YOY Total Revenue Growth ROW - Exciting Opportunities for Long-Term Growth 2018E Total Revenues DURABILITY Market-leading ARV business supported by strong R&D and vertical integration Established, robust commercial platform and partnership network across ROW Broad and diversified portfolio, with no
Slide 77: Growth Opportunities Across ROW
Growth Opportunities Across ROW Rx/Bx Gx OTC Cross-pollination of portfolio into ROW markets (e.g. China, SE Asia, Brazil, Mexico) Partnership opportunities to provide high-quality medicine in emerging markets Increased focus on complex products portfolio Leverage HIV learnings to expand into new di
Slide 78: Broad and Diverse ROW Footprint Provides Durable Platform for Growth
Broad and Diverse ROW Footprint Provides Durable Platform for Growth Sales across ~125 countries in ROW region ~60 countries with in-house commercial presence with a sales force of >2,000 ~800 distinct products across the region Pipeline of ~1,000 products pending approval Significant experience acr
Slide 79: North America
North America
Slide 80: North America – Maintaining and Strengthening Our Leadership
DURABILITY North America – Maintaining and Strengthening Our Leadership Robust complex product launches One of industry’s broadest pipelines: 359 products in pipeline/267 pending approvals Portfolio of >650 distinct products in the U.S. Prudent managing of portfolio 2nd largest provider of prescript
Slide 81: Growth Opportunities Across North America
Rx Gx/Bx OTC Growth Opportunities Across North America Continue to drive glatiramer acetate conversion Maximize Wixela Inhub opportunity Successfully launch pegfilgrastim biosimilar, Gx Restasis and other products Continue to focus on injectable portfolio expansion Leverage and expand healthcare off
Slide 82: U.S. Durability: A Deeper Dive
U.S. Durability: A Deeper Dive Dermatology Biosimilars Other Strategic Products OTC Respiratory & Allergy Injectables Pipeline of complex, long-acting injectables 18 injectable U.S. product launches in last 12 months Robust future with complex launches, e.g. Wixela, Gx Symbicort and Revefenacin Sale
Slide 83: Key Takeaways
Key Takeaways
Slide 84: Platform Poised to Outperform Markets Globally
Platform Poised to Outperform Markets Globally Build upon diversity within our businesses: Maintain leadership and seize opportunities in U.S. Capitalize on ex-U.S. growth Further balance portfolio among Rx, Gx and OTC Execute on science with focus on complexity feeding the durability of the portfol
Slide 85: Financial Durability and Diversification
Financial Durability and Diversification
Slide 86: Financial Performance: Consistent Execution on Commitments
Financial Performance: Consistent Execution on Commitments 11% CAGR(2) 15% CAGR(2) 13% CAGR(2) Adjusted EPS(1) Adjusted EBITDA(1) Total Revenues (1) Adjusted metrics are non-GAAP financial measures. Please see Appendix or investor.mylan.com for the most directly comparable U.S. GAAP financial measur
Slide 87: Strong Performance Across Geographies
Strong Performance Across Geographies Third Party Net Sales Segment Profitability* 2% CAGR 103% CAGR 48% CAGR $ in millions *Segment profitability represents segment gross profit less direct R&D expenses and direct SG&A expenses. See Mylan’s Form 10-K for the year ended December 31, 2017 for more in
Slide 88: Segment Revenue Guidance for 2018
Segment Revenue Guidance for 2018 Total Revenue % Growth vs 2017 Key Drivers Europe Rest of World Flat High-single digits High-single digits New key strategic product launches: Wixela Pegfilgrastim Carryforward of 2017 launches including Glatiramer Acetate and Generic Estrace Lower sales on existing
Slide 89: Bridge to 2018: Adjusted EPS Guidance
Bridge to 2018: Adjusted EPS(1) Guidance (1) Adjusted metrics are non-GAAP financial measures. Please see Appendix or investor.mylan.com for the most directly comparable U.S. GAAP financial measures and reconciliations of such non-GAAP financial measures to the most directly comparable U.S. GAAP fin
Slide 90: 2018 Financial Guidance Summary
2018 Financial Guidance Summary Total Revenues $11,750 - $13,250 Adjusted Gross Margins(1) 55.0 – 56.5% Adjusted R&D(1) as % of Total Revenues 5.0 – 6.0% Adjusted SG&A(1) as % of Total Revenues 17.5 – 20.0% Adjusted EBITDA(1) $4,000 – $4,500 Adjusted Net Earnings(1) $2,700 – $2,900 Adjusted EPS(1) $
Slide 91: Mylan's Cash Flows Are Stable And Durable
Mylan’s Cash Flows Are Stable And Durable *Cash Flow represents adjusted net cash provided by operating activities. Adjusted net cash provided by operating activities is a non-GAAP financial measure. Please see the Appendix or investor.mylan.com for the most directly comparable U.S. GAAP financial m
Slide 92: Strong and Consistent Cash Flow and Return on Invested Capital
2014 – 2017 Average Strong and Consistent Cash Flow and Return on Invested Capital (ROIC) Adjusted metrics are non-GAAP financial measures. Please see Appendix or investor.mylan.com for the most directly comparable U.S. GAAP financial measures and reconciliations of such non-GAAP financial measures
Slide 93: Growth Achieved with Balance Sheet Discipline
Growth Achieved with Balance Sheet Discipline (1) Leverage ratio refers to total notional debt to Credit Agreement Adjusted EBITDA leverage ratio, which is a non-GAAP financial measures. Please see the Appendix or investor.mylan.com for the most directly comparable U.S. GAAP financial measures and r
Slide 94: Ongoing Execution, Performance and Investment
Ongoing Execution, Performance and Investment $0.80 $1.30 $1.61 $2.04 $2.59 $2.89 $4.30 $3.56 $4.89 $5.20-$5.60 $0.3M Adjusted FCF R&D $303M Cap $165M R&D $252M Cap $154M R&D $272M Cap $193M R&D $291M Cap $280M R&D $389M Cap $305M R&D $456M Cap $335M R&D $561M Cap $325M R&D $650M Cap $363M R&D $696M
Slide 95: Our Differentiated Business Model
Our Differentiated Business Model ACCESS is our core purpose. The more diversity we achieve through driving access, the more it enhances the DURABILITY of our business model. To drive access, Mylan has built tremendous DIVERSITY into our commercial, operational and scientific platforms.
Slide 96: Appendix
Appendix
Slide 97: Non-GAAP Financial Measures
Non-GAAP Financial Measures This presentation includes the presentation and discussion of certain financial information that differs from what is reported under accounting U.S. GAAP. These non-GAAP financial measures, including, but not limited to, adjusted EBITDA, adjusted EPS, adjusted gross margi
Slide 98: Reconciliation of non-GAAP financial measures: Adjusted EBITDA
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions) Adjusted EBITDA
Slide 99: Reconciliation of non-GAAP financial measures
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions, except per share amounts) It is not mathematically possible to calculate the CAGR for U.S. GAAP EPS for the period 2008-2017 since the U.S. GAAP diluted EPS for 2008, the first year in the period, was
Slide 100: Reconciliation of non-GAAP financial measures
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions, except per share amounts)
Slide 101: Reconciliation of non-GAAP financial measures
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions, except per share amounts)
Slide 102: Reconciliation of non-GAAP net earnings and EPS 2008-2010
Year Ended Year Ended December 31, December 31, (Unaudited; USD in millions, except for EPS) 2010 2010 2009 2009 2008 2008 U.S. GAAP net earnings (loss) attributable to Mylan N.V. and U.S. GAAP diluted EPS $ 224 $ 0.68 $ 94 $ 0.30 $ (335 ) $ (1.10 ) Purchase accounting related amortization (primaril
Slide 103: Notional Debt to Credit Agreement Adjusted EBITDA Leverage Ratio
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions) Notional Debt to Credit Agreement Adjusted EBITDA Leverage Ratio and Target Leverage Ratio Notional Debt to Credit Agreement Adjusted EBITDA Leverage Ratio The stated non-GAAP financial measure notiona
Slide 104: Reconciliation of non-GAAP financial measures: Adjusted R&D
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions) Adjusted R&D
Slide 105: Reconciliation of non-GAAP financial measures: Adjusted Free Cash Flow
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions) Adjusted Free Cash Flow
Slide 106: Reconciliation of non-GAAP financial measures: Adjusted Free Cash Flow
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions) Adjusted Free Cash Flow * 2008 Adjusted free cash flow was $0.3 million. *
Slide 107: Adjusted Pre-tax Income and Adjusted Interest Expense
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions) Adjusted Pre-tax Income and Adjusted Interest Expense
Slide 108: Return on Invested Capital
Mylan N.V. and Subsidiaries Reconciliation of non-GAAP financial measures (Unaudited; in millions) Return on Invested Capital