Alvotech · NASDAQ:ALVO
Alvotech — SPAC Merger (December 2021)
62 slides from Alvotech's SPAC merger presentation, Dec 7, 2021
Slide 1: Investor Presentation December 2021
INVESTOR PRESENTATION December 2021
Slide 2: Disclaimer
This investor presentation (this “Presentation”) is for informational purposes only to assist interested parties in making their own evaluation with respect to the proposed business combination (the “Business Combination”) between Oaktree Acquisition Corp. II (“SPAC”) and Alvotech Holdings S.A. (tog
Slide 3: Use of Projections; Industry and Market Data
Use of Projections This Presentation contains financial forecasts with respect to the Company’s projected financial results, including Revenue and Adjusted EBITDA, for the Company’s fiscal years 2021, 2025 and from 2025-2030. The Company’s independent auditors have not audited, reviewed, compiled or
Slide 4: Oaktree Is A Compelling SPAC Partner For Alvotech
Oaktree Is A Compelling SPAC Partner For Alvotech Having Been A Long-Term Investor Long-term, High-conviction Partner in Oaktree › Strategic partner since initially investing in December 2018 › Deep understanding and familiarity with both the business and management team developed Dedicated Life Sci
Slide 5: Alvotech Is Founder Robert Wessman's Third Platform In The Pharma Sector
Alvotech Is Founder Robert Wessman’s Third Platform In The Pharma Sector Robert Wessman Background Revenue Increase Under Wessman Leadership $ in millions Seasoned pharma executive that Past platforms that Current Platform have created billions in Alvotech has led 50+ strategic acquisitions in value
Slide 6: Growth Platform Ready To Be Deployed
Growth Platform Ready To Be Deployed Having Been Built Over 9 Years With ~$1 Billion Of Invested Capital (3) Build Foundation Commercial Readiness Deploy Platform (2013-2017) (2018-2020) (2021-2025+) ✓ Set 10-year platform vision ✓ Established global distribution • Existing pipeline matures and new
Slide 7: Alvotech: Pure-Play Access To The Rapidly Growing Biosimilar Market
Alvotech: Compelling Platform Providing Pure-Play Access To The Rapidly Growing Biosimilar Market • Pioneers in biosimilar development with a track record of obtaining 1 PROVEN LEADERSHIP TEAM marketing authorization for 17 biosimilars and 8 biologics globally • Significant acceleration of originato
Slide 8: Proven Leadership Team
PROVEN LEADERSHIP TEAM
Slide 9: Proven & Highly Experienced Management Team
Proven & Highly Experienced Management Team Having Successfully Developed 17 Biosimilars 20 20 20 15 20 MARK LEVICK, JOSEPH E. JOEL MORALES, ANIL OKAY, MING LI, Chief Executive MCCLELLAN, Chief Financial Chief Strategy Officer Chief Scientific Officer Commercial Officer 20 15 29 20 15 TANYA ZHAROV,
Slide 10: Significant Market Opportunity
SIGNIFICANT MARKET OPPORTUNITY
Slide 11: Highly Aligned Social And Corporate Purpose
Highly Aligned Social And Corporate Purpose Corporate Purpose Social Purpose Alvotech is dedicated to Alvotech aims to be the making patients’ lives leading supplier of better by improving access biosimilars globally to affordable biosimilar medicines and the Our corporate purpose is sustainability
Slide 12: Biologics Are Driving The Next Generation Of Treatments For Patients
Biologics Are Driving The Next Generation Of Treatments For Patients Biologics Overview Biologics • What is a biologic? • Large, complex molecules produced in a living system that treat medical conditions Treats chronic and otherwise difficult-to- Synthesis Living systems • treat diseases Uniformity
Slide 13: Biologic Approvals Are Increasing Rapidly
Biologic Approvals Are Increasing Rapidly, A Leading Indicator For The Biosimilar Opportunity Originator Biologics Market is Large and Growing Increasing US biologic medicine approvals… …is driving expectations for rapidly growing $ sales Number of FDA Approvals Total Global Biologics Market Size ($
Slide 14: Biosimilars Are Complex Yet Cost-Effective Alternatives To Biologics
Biosimilars Are Complex, Requiring Technical Know-How; However Are Cost-Effective Alternatives To Biologics Originator Biologics Biosimilar Biologic medicine that is highly similar to, and has Novel protein-based medicines that demonstrate Description no clinically meaningful differences from, a hig
Slide 15: Biosimilars Are Entering A Period Of Substantial Growth
Biosimilars Are Entering A Period Of Substantial Growth As Early Biologics Lose Patent Protection Opportunity for Biosimilars to Expand Patient Access Biosimilars Adoption Growing Rapidly (3) • High price of biologic medicines is placing a significant cost burden on healthcare systems Total Global B
Slide 16: Purpose-Built Biosimilar Platform; Global Commercial Partner Network
PURPOSE-BUILT BIOSIMILAR PLATFORM GLOBAL COMMERCIAL PARTNER NETWORK
Slide 17: Strategically Developed Platform Designed To Maximize Quality And Efficiency
Strategically Developed Platform Designed To Maximize Quality, Cost Containment And Efficiency To Market PLATFORM ELEMENT ALVOTECH APPROACH Global end-to-end R&D platform spanning six locations with rigorous quality RESEARCH AND focus designed to de-risk development early and drive efficient advance
Slide 18: R&D Process Designed To Optimize Development Outcomes
R&D Process Designed To Optimize Development Outcomes, While Balancing Time And Cost Focus Approach • Prioritize analytical similarity early in programs to de-risk development programs Maximize • Rigorously align global development strategies with global regulatory authorities to Development Success
Slide 19: Extensive Manufacturing Capabilities Expands Addressable Market
Extensive Manufacturing Capabilities Expands Addressable Market Key Features Technology & Capabilities • Approximately 140,000ft2 facility including drug substance capacity to support pipeline through 2030 (1) • Ongoing expansion project to add 135,000ft2 extension in early 2024 to expand ✓ Capacity
Slide 20: Network Of High-Quality Regional Partners Provides Global Commercial Reach
Network Of High-Quality Regional Partners Provides Global Commercial Reach Alvotech’s Partner Partnered Territories Selection Criteria Strategic Positioning Track record of success in local market hared Risk Dynamic SVALBARD (NORWAY) GREENLAND Structurally aligned incentives Attractive Economics Upf
Slide 21: Key Regional Partners Have Committed Up To $1.15Bn In License Fees
Key Regional Partners Have Committed Up To $1.15Bn In Potential License Fees ($950MM Outstanding) 2020A Licensed Alvotech Geographic 2020A Licensed Alvotech Geographic Partner Partner Partner Rev Products Rights Partner Rev Products Rights Australia, New $2.7Bn (1) 5 Zealand, South Africa USA $16.7B
Slide 22: Diverse Pipeline With Significant TAM
DIVERSE PIPELINE WITH SIGNIFICANT TAM
Slide 23: Strategically Constructed Pipeline Of Biosimilars Representing $80Bn+ TAM
Strategically Constructed Pipeline Of Biosimilars Representing $80Bn+ TAM Alvotech’s Current Biosimilar Pipeline – Global Peak Branded Sales of Originator Branded Biologics $30.0Bn $82.2Bn $3.8Bn $52.2Bn $6.6Bn Future Growth $10.1Bn $10.6Bn Market growth Additional internal $21.1Bn programs -platfor
Slide 24: Current Pipeline Addresses Three Therapeutic Areas
Current Pipeline Addresses Three Therapeutic Areas With Multiple Filings Expected By The End Of 2023 Reference Therapeutic (1) Next Expected Program Pre-clinical Clinical Filing Recent Updates Product Area Catalyst AVT02 AVT02 (high 4Q 2021 (high concentration formulation) Humira® Immunology Sept 20
Slide 25: AVT02: Multiple Points Of Differentiation
AVT02: Multiple Points Of Differentiation, Including High Concentration And Potential Interchangeability Alvotech Program AVT02 HUMIRA® TRx by Concentration Branded Biologic Humira® Alvotech (Generic Name) (Adalimumab) is one of two addressing 80% Therapeutic Area Immunology of market Originator Sal
Slide 26: AVT04: Rapidly Growing Product Ripe For Biosimilar Entry
AVT04: Rapidly Growing Product Ripe For Biosimilar Entry Due To High Price Point Alvotech AVT04 Historical and Projected Stelara® Sales ($Bn) Program Branded Biologic Stelara® (Generic Name) (Ustekinumab) Stelara® Annual Cost of Treatment: $144,000(2) $9.5 Therapeutic Area Immunology ’17A-’21E CAGR:
Slide 27: Broader Product Pipeline Is Attractive And Will Be Supplemented By In-Licensing
Broader Product Pipeline Is Attractive And Will Be Supplemented By Additional In-Licensing Alvotech AVT03 AVT05 AVT06 AVT16 / AVT33 Program Branded Biologic Undisclosed Generic Name Denosumab Golimumab Aflibercept Undisclosed Immunology & Therapeutic Area Oncology Immunology Ophthalmology Oncology O
Slide 28: Attractive Financial Profile
ATTRACTIVE FINANCIAL PROFILE
Slide 29: Financial Forecast Overview
Financial Forecast Overview Overview Basis of • All financials are presented on an International Financial Reporting Standards (IFRS) basis of accounting Presentation • Detailed product-level in-market revenue build based on estimated penetration and pricing discount relative to originators Risk Adj
Slide 30: Attractive Revenue Potential As Products Commercialize
Attractive Revenue Potential As Products Commercialize Risk Adjusted Revenue Commentary $ in millions 2021-2025 • Milestones: ongoing payments Long-term from commercial partners that help growth offset R&D costs potential High single digit • Programs: 5 launched products growth expected by 2025 in >
Slide 31: Leverageable Business Model Designed To Produce Attractive Margins
Leverageable Business Model Designed To Produce Attractive Margins That Can Expand As The Platform Scales Illustrative Adjusted EBITDA Potential Commentary $ in millions Margin Profile Enabled by: Long-term • Portfolio selection focus on high dollar and value reference products margin potential • Mi
Slide 32: Financial Guidance Summary (Risk Adjusted)
Financial Guidance Summary (Risk Adjusted) 2021E 2025E – 2030E $ millions Product Revenue (1) 0 85% of total revenue Milestone Revenue (1) $30 – $60 15% of total revenue (Cumulative $550MM+ from ’22E – ‘25E) (1) High single-digit Total Alvotech Revenue $30 – $60 $800+ revenue growth COGS (2) N.A. ~1
Slide 33: Additional Opportunities Beyond The Financial Forecast
Additional Opportunities Beyond The Financial Forecast Conservative Baseline Projections Omit Numerous Opportunities For Upside Interchangeability Earnings Revenue from In-licensing of upside from contribution additional R&D external existing pipeline from China joint programs as programs venture pi
Slide 34: Transaction Summary
TRANSACTION SUMMARY
Slide 35: Highly Aligned Transaction Structure With 100% Rollover
Highly Aligned Transaction Structure With 100% Rollover By Existing Shareholders Transaction Overview Illustrative Pro Forma Valuation ($mm) • Oaktree Acquisition Corp. II (NYSE: “OACB”) to combine with Alvotech at an Share Price $10.00 implied $1.8 billion pre-money equity value and a $2.25 billion
Slide 36: Well-Positioned, Pure-Play Biosimilars Platform
Well-Positioned, Pure-Play Biosimilars Platform Adjacent, Less Comparable Most Comparable Listing Location (1) US India US / Iceland South Korea South Korea Structure Public Subsidiary Public (2) Public JV Primary Biosimilar Focus Biosimilars R&D Biosimilar Manufacturing Global Reach Current regulat
Slide 37: Well-Positioned, Pure-Play Biosimilars Platform (Cont'd)
Well-Positioned, Pure-Play Biosimilars Platform (Cont’d) Key Pure-Play Listed Comparable (3) (4) (Parent) 82.2 (1) rentBn) 61.9 68.7 $ 46.4 52.2 Cur( –eline 21.7 (2) TAM Pip Total Enterprise Value ($Bn) $1.5 $6.4 $2.3 (6) $25.7 $45.5 (5) EV / NTM EBITDA N/M (7) 20.4x N/A 26.3x 68.2x ancial trics ’21
Slide 38: Transaction Represents An Attractive Entry Point
Transaction Represents An Attractive Entry Point Transaction Value Today Illustrative Current Value Illustrative Future Value ($Bn) Meaningful upside potential from $9.6 transaction value and illustrative current value $7.2 Current EV represents ~45-60% discount to illustrative current $5.6 value $4
Slide 39: Alvotech: A Differentiated Global Biosimilars Company
Alvotech: A Differentiated Global Biosimilars Company 1 PROVEN LEADERSHIP TEAM 2 SIGNIFICANT MARKET OPPORTUNITY 3 PURPOSE-BUILT BIOSIMILAR PLATFORM 4 GLOBAL COMMERCIAL PARTNER NETWORK 5 DIVERSE PIPELINE WITH SIGNIFICANT TAM 6 ATTRACTIVE FINANCIAL PROFILE 39
Slide 40: Appendix: Select Management Team Biographies
APPENDIX SELECT MANAGEMENT TEAM BIOGRAPHIES
Slide 41: Highly Experienced Leadership Team
Highly Experienced Leadership Team 20 20 20 15 20 MARK LEVICK, JOSEPH E. JOEL MORALES, ANIL OKAY, MING LI, Chief Executive MCCLELLAN, Chief Financial Chief Chief Strategy Officer Chief Scientific Officer Commercial Officer Officer Officer • 20 years of industry • 20 years of industry • 20 years of i
Slide 42: Highly Experienced Leadership Team (Cont'd)
Highly Experienced Leadership Team (Cont’d) 20 15 29 20 15 PHILIP TANYA ZHAROV, SEAN GASKELL, REEM MALKI CARAMANICA, ANDREW ROBERTS, Deputy CEO Chief Technical Chief Quality Chief Portfolio Officer Officer Chief IP Counsel, Officer Deputy General Counsel • 20 years of industry • 15 years of industry
Slide 43: Appendix: Biosimilar Background Information
APPENDIX BIOSIMILAR BACKGROUND INFORMATION
Slide 44: Biosimilars Are Highly Comparable To Biologics
Biosimilars Are Highly Comparable To Biologics, An Important Class Of Medicine BIOLOGIC BIOSIMILAR Development Path • Proof of quality and analytical similarity • Pharmacokinetic bioequivalence • Clinical data showing comparable safety and efficacy • Support pharmacy substitution and interchangeabil
Slide 45: Regulatory Definition Of Biosimilars
Regulatory Definition Of Biosimilars A biosimilar is a biologic medicinal product that contains a version of the active substance of an already authorized original biologic medicinal product (reference medicinal product). A biosimilar demonstrates similarity to the reference medicinal product in ter
Slide 46: Key Stages And Milestones Of Biosimilar Development
Key Stages And Milestones Of Biosimilar Development 1 2 3 4 Early Phase Pre-Clinical Manufacturing / Analytics-Development Submission Development LCM Project Selection Pilot & GMP Mfg. PK/PD Study & Approval Launch Post Approval& Cell Line Process Confirmatory Patient Study • Project selection crite
Slide 47: Interchangeability May Enhance Speed Of Biosimilar Adoption
Interchangeability May Enhance Speed Of Biosimilar Adoption And Growth › Interchangeable designation in the US allows for substitution without authorization by the prescribing physician(1) – Pharmacists can substitute the interchangeable biosimilar for the originator without approval – Interchangeab
Slide 48: Appendix: Clinical Program And Capabilities Detail
APPENDIX CLINICAL PROGRAM AND CAPABILITIES DETAIL
Slide 49: Rigorous Approach To Constructing An Attractive Biosimilar Portfolio
Rigorous Approach To Strategically Constructing An Attractive Biosimilar Portfolio Alvotech Portfolio Selection Criteria Launch Timing › Potential to be in the first wave of launches Launch › Focus on constructing balanced portfolio Timing Fit in Alvotech › Volume/price ratio is carefully assessed P
Slide 50: AVT02: Global program included 1500+ subjects
AVT02: Global program included 1500+ subjects Subjects (1) Study Overview Milestones Enrolled • 3-arm parallel study of AVT02 compared to EU-Humira® and • Enrollment completed in December 2019 PK Similarity Study 390 US-Humira® in healthy adult subjects • Study met its primary endpoints for all esta
Slide 51: AVT02-GL-101 PK Similarity Study Meets Primary And Secondary Objectives
AVT02: AVT02-GL-101 Pharmacokinetic (PK) Similarity Study Meets Primary And Secondary Objectives Study Design and Outcomes PK Similarity Top Line Results Primary Outcomes: › Bioequivalence criteria for all three PK parameters Cmax, AUC0-t and AUC0-inf for all pairwise comparisons were met confirming
Slide 52: AVT02-GL-301 Comparative Clinical Efficacy & Safety Study
AVT02: AVT02-GL-301 Comparative Clinical Efficacy & Safety Study Achieves 1 & 2 Endpoints Study Design and Top Line Conclusion Efficacy and Safety Outcome Data Percent improvement in PASI from baseline to Week 16 was therapeutically significant in both groups Similar safety profile between AVT02 and
Slide 53: AVT02-GL-302 Switching Study Supports Interchangeable Approval
AVT02: Successful AVT02-GL-302 Switching Study Will Support Potential Approval As Interchangeable Product In the US Study Details › Parallel-group study to evaluate PK, efficacy, safety, and immunogenicity between patients undergoing repeated switches between Humira® and AVT02 › Study designed accor
Slide 54: AVT02: Competitive Landscape Overview
AVT02: Competitive Landscape Overview Product information US Competitive Landscape EU Competitive Landscape AVT02 is one of the only biosimilars to Program Manufacturer Strength Marketer Approval Status Marketer Approval Status high concentration Humira® (6) Positive CHMP AVT02 Alvotech 100mg / mL T
Slide 55: AVT04: Clinical Development Program Designed To Support Biosimilarity
AVT04: Clinical Development Program Designed To Support Demonstration Of Biosimilarity ID: AVT04-GL-101 Description: PK Similarity Study in Healthy Male Volunteers, First Subject First Visit Q2 2021 To compare the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04 with EU-ap
Slide 56: AVT04: Competitive Landscape Overview
AVT04: Competitive Landscape Overview AVT04 is one of few known SP2/0 Product information US EU cell line based program Program Developer Development Status Commercial Partner Commercial Partner No publicly disclosed FDA/EMA biosimilar submissions to date AVT04 Alvotech P3 (EU) Teva Stada Some compe
Slide 57: Global Operating Footprint With Differentiated Biosimilar Capabilities
Global Operating Footprint With Differentiated Biosimilar Capabilities R&D Focused Sites JULICH SITE Cell line, media, process, and functional assay development proficiency HANOVER SITE Expertise in glycoprotein characterization methods and analyses VIRGINIA SITE Regulatory, government affairs, and
Slide 58: Appendix: CCHT Joint Venture
APPENDIX CCHT JOINT VENTURE
Slide 59: Alvotech Well-Positioned In The China Biosimilars Market Through Its China JV
Alvotech Well-Positioned In The Promising China Biosimilars Market Through Its China JV Access to the Second Largest Biopharma Market in the World JV Partner Overview › Alvotech formed a 50/50 JV with Changchun High and New › CCHT was established in 1993; Changchun Municipal People’s Technology Indu
Slide 60: China JV Manufacturing Facility: Changchun
China JV Manufacturing Facility: Changchun MANUFACTURING SITE IN CHINA › Currently in facility construction phase with building certification to be completed mid-2022 › Broke ground in May 2020 with target engineering runs in late 2022 › Initial capacity will be designed for:—4 x 2,000L fed batch SU
Slide 61: Alvotech's China Commercial Partner: Yangtze River Pharmaceutical Group
Alvotech’s China Commercial Partner: Yangtze River Pharmaceutical Group YRPG Network & Infrastructure China Coverage Overview › YRPG has well-established distribution networks cover all districts nationally with more than 10,000 hospitals, 1,200 chain stores, and 20,000 retails, which account for ~8
Slide 62: Risk Factors
Carefully consider the following risk factors, among others that will be contained in (or incorporated by reference into) the proxy statement/prospectus, related to Alvotech’s business, reputation, financial condition, results of operations, revenue and the future prospects if the business combinati