Alvotech · NASDAQ:ALVO
Alvotech — SPAC Merger (February 2022)
64 slides from Alvotech's SPAC merger presentation, Feb 15, 2022
Slide 1: Investor Presentation February 2022
Oaktree Acquisition Corp. II (Commission File No. 001-39526) Pursuant to Rule 425 under the Securities Act of 1933 And Deemed Filed und Rule 14a-12 under the Securities Exchange Act of 1934 Subject Company: Alvotech Lux Holdings S.A.S. INVESTOR PRESENTATION February 2022
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 Past platforms that Current Platform Seasoned pharma executive that 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 (3) Over 9 Years With ~$1 Billion Of Invested Capital Build Foundation Commercial Readiness Deploy Platform (2013-2017) (2018-2020) (2021-2025+) ✓ Established global distribution • Existing pipeline matures and new ✓ Set 10-year platform vision
Slide 7: Alvotech: Compelling Platform Providing Pure-Play Access To The 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 PROVEN LEADERSHIP TEAM 1 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, MCCLELLAN, Chief Chief Executive Chief Financial Chief Strategy Commercial Officer Chief Scientific Officer Officer Officer Officer 20 15 2
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 sustainability Our corporate purpose is
Slide 12: Biologics Are Driving The Next Generation Of Treatments For Patients
Biologics Are Driving The Next Generation Of Treatments For Patients Biologics Biologics Overview • What is a biologic? • Large, complex molecules produced in a living system that treat medical conditions Synthesis Living systems • Treats chronic and otherwise difficult-to- 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 But 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 no clinically meaningful differences from, a Description 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 (3) Opportunity for Biosimilars to Expand Patient Access Biosimilars Adoption Growing Rapidly • High price of biologic medicines is placing a significant cost Total Global Biosimilar Market Size ($Bn) 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, Cost Containment 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 focus designed to de-risk development early and drive efficient advancement RESEARCH
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 Capacity Located in Iceland
Extensive Manufacturing Capacity Located in Iceland Key Features Technology & Capabilities 2 • Approximately ~275,000ft facility (inclusive of ongoing expansion) with existing 4- (1) wall drug substance capacity to support pipeline through 2030 Capacity and Scalability ✓ • Commercial product manufac
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 P Strategic Positioning Track record of success in local market SVALBARD (NORWAY) P Shared Risk Dynamic GREENLAND Structurally aligned incentives P Attractive Econom
Slide 21: Key Regional Partners Have Committed Up To $1.15Bn In Potential 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 (1) Zealand, South $2.7Bn 5 Africa US $16.7B
Slide 22: Diverse Pipeline With Significant TAM
DIVERSE PIPELINE WITH SIGNIFICANT TAM
Slide 23: Since Transaction Announcement, Alvotech Has Continued to Deliver on its Strategy
Since Transaction Announcement, Alvotech Has Continued to Deliver on its Strategy + Upsizing of + oversubscribed PIPE BiosanaPharma AVT23 licensing agreement + Approval of SIMLANDI th › On January 18 , Alvotech (AVT02) in Canada announced $21m in nd European Union › On February 2 , Alvotech addition
Slide 24: Strategically Constructed Pipeline Of Biosimilars Representing $85Bn+ TAM
Strategically Constructed Pipeline Of Biosimilars Representing $85Bn+ TAM Alvotech’s Current Biosimilar Pipeline – Global Peak Branded Sales of Originator Branded Biologics $30.0Bn $85.5Bn $3.4Bn $3.7Bn $6.6Bn Future Growth $10.0Bn Market growth $10.8Bn Additional internal $21.0Bn programs - platfor
Slide 25: Current Pipeline Addresses Three Therapeutic Areas With Multiple Filings Expected
Current Pipeline Addresses Three Therapeutic Areas With Multiple Filings Expected By The End Of 2023 Reference Therapeutic Next Expected (1) Program Pre-clinical Clinical Filing Recent Updates Product Area Catalyst AVT02 AVT02 Commercial (high ® (high concentration formulation) Humira Immunology Sep
Slide 26: AVT02: Multiple Points Of Differentiation
AVT02: Multiple Points Of Differentiation, Including High Concentration And Potential Interchangeability Alvotech Program AVT02 HUMIRA® TRx by Concentration ® Branded Biologic Humira (Generic Name) (Adalimumab) Alvotech is one of the few Therapeutic Area Immunology players addressing (1) Originator
Slide 27: AVT04: Rapidly Growing Product Ripe For Biosimilar Entry
AVT04: Rapidly Growing Product Ripe For Biosimilar Entry Due To High Price Point Alvotech Historical and Projected Stelara® Sales ($Bn) AVT04 Program ® Branded Biologic Stelara 12.0 800 (2) (Generic Name) (Ustekinumab) Stelara® Annual Cost of Treatment: $144,000 Therapeutic Area Immunology 700 ’17A-
Slide 28: 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 (
Slide 29: BiosanaPharma Agreement Overview
BiosanaPharma Agreement Overview On February 2, 2022, Alvotech and BiosanaPharma entered into an exclusive global licensing agreement to co-develop AVT23 AVT23 Overview 3C Technology Platform ▪ AVT23 (aka BP001) is a late-stage biosimilar candidate for Xolair ▪ High productivity, flexible, small foo
Slide 30: Attractive Financial Profile
ATTRACTIVE FINANCIAL PROFILE
Slide 31: 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 32: 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 33: 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: • Portfolio selection focus on high Long-term value reference products dollar and margin • Milestone re
Slide 34: Financial Guidance Summary (Risk Adjusted)
Financial Guidance Summary (Risk Adjusted) 2021E 2025E 2025E – 2030E $ millions (1) Product Revenue 0 85% of total revenue 15% of total revenue (1) Milestone Revenue $30 – $60 (Cumulative $550MM+ from ’22E – ‘25E) High single-digit (1) Total Alvotech Revenue $30 – $60 $800+ revenue growth (2) COGS N
Slide 35: Additional Opportunities Beyond The Financial Forecast
Additional Opportunities Beyond The Financial Forecast Conservative Baseline Projections Omit Numerous Opportunities For Upside Interchangeability Earnings Revenue from In-licensing of upside from contribution additional R&D external existing pipeline from China joint programs as programs programs v
Slide 36: Transaction Summary
alvotech ij i TRANSACTION SUMMARY
Slide 37: Highly Aligned Transaction Structure With 100% Rollover By Existing Shareholders
Highly Aligned Transaction Structure With 100% Rollover By Existing Shareholders Transaction Overview Illustrative Pro Forma Valuation ($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 $2.25 billion
Slide 38: Well-Positioned, Pure-Play Biosimilars Platform
Well-Positioned, Pure-Play Biosimilars Platform Adjacent, Less Comparable Most Comparable (1) Listing Location US India US / Iceland South Korea South Korea (2) Structure Public Subsidiary Public Public JV Primary Biosimilar Focus ûPPPP Biosimilars R&D PPPPP Biosimilar Manufacturing ûPPPP Global Rea
Slide 39: Well-Positioned, Pure-Play Biosimilars Platform (Cont'd)
Well-Positioned, Pure-Play Biosimilars Platform (Cont’d) Key Pure-Play Listed Comparable (3) (4) (Parent) (Parent) 85.5 69.1 66.4 55.5 46.1 (2) 21.4 (6) Total Enterprise Value ($Bn) $0.9 $6.8 $2.3 $18.3 $40.1 (7) EV / NTM EBITDA N/M 20.6x N/A 20.4x 60.3x ’21E – ’25E Revenue CAGR 28% N/A >90% 12% 17%
Slide 40: Transaction Represents An Attractive Entry Point
Transaction Represents An Attractive Entry Point Transaction Value Today Illustrative Current Value Illustrative Future Value ($Bn) Meaningful upside $9.6 potential from transaction value and illustrative current value $7.2 Current EV represents ~45-60% discount to illustrative current $5.6 value $4
Slide 41: Alvotech: A Differentiated Global Biosimilars Company
Alvotech: A Differentiated Global Biosimilars Company PROVEN LEADERSHIP TEAM 1 SIGNIFICANT MARKET OPPORTUNITY 2 PURPOSE-BUILT BIOSIMILAR PLATFORM 3 GLOBAL COMMERCIAL PARTNER NETWORK 4 5 DIVERSE PIPELINE WITH SIGNIFICANT TAM ATTRACTIVE FINANCIAL PROFILE 6 41
Slide 42: Appendix: Select Management Team Biographies
APPENDIX SELECT MANAGEMENT TEAM BIOGRAPHIES
Slide 43: Highly Experienced Leadership Team
Highly Experienced Leadership Team 20 20 15 20 20 MARK LEVICK, JOSEPH E. JOEL MORALES, ANIL OKAY, MING LI, MCCLELLAN, Chief Chief Executive Chief Financial Chief Strategy Commercial Officer Chief Scientific Officer Officer Officer Officer • 15 years of industry • 20 years of industry • 20 years of i
Slide 44: Highly Experienced Leadership Team (Cont'd)
Highly Experienced Leadership Team (Cont’d) 20 15 15 20 29 PHILIP TANYA ZHAROV, SEAN GASKELL, REEM MALKI ANDREW ROBERTS, CARAMANICA, Chief Technical Deputy CEO Chief Quality Chief Portfolio Officer Chief IP Counsel, Officer Officer Deputy General Counsel • 15 years of industry • 20 years of industry
Slide 45: Appendix: Biosimilar Background Information
APPENDIX BIOSIMILAR BACKGROUND INFORMATION
Slide 46: 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 47: 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 48: Key Stages And Milestones Of Biosimilar Development
Key Stages And Milestones Of Biosimilar Development 1 2 3 4 Manufacturing / Analytics Early Phase Pre-Clinical Submission Development Development & Approval PK/PD Study Pilot & GMP Mfg. Cell Line Process Confirmatory Patient Study • Project selection criteria include • Confirm high quality drug • Ex
Slide 49: Interchangeability May Enhance Speed Of Biosimilar Adoption And Growth
Interchangeability May Enhance Speed Of Biosimilar Adoption And Growth › Interchangeable designation in the US allows for substitution without (1) authorization by the prescribing physician ‒ Pharmacists can substitute the interchangeable biosimilar for the originator without approval ‒ Interchangea
Slide 50: Appendix: Clinical Program And Capabilities Detail
APPENDIX CLINICAL PROGRAM AND CAPABILITIES DETAIL
Slide 51: Rigorous Approach To Strategically Constructing An Attractive Biosimilar Portfolio
Rigorous Approach To Strategically Constructing An Attractive Biosimilar Portfolio Potential Ways to Differentiate › Identify early, underappreciated originator markets Market Intel › Anticipate originator strategies and adapt accordingly Differentiation › Portfolio offerings and brand awareness Com
Slide 52: 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 ® US-Humira in healthy adult subjects PK Similarity Study 390 • Study met its primary endpoints for all es
Slide 53: AVT02-GL-101 Pharmacokinetic 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 54: AVT02-GL-301 Comparative Clinical Efficacy & Safety Study Achieves Endpoints
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
Slide 55: AVT02-GL-302 Switching Study Can Support Interchangeable Approval
AVT02: Successful AVT02-GL-302 Switching Study Can Support Potential Approval As Interchangeable Product In the US Subject study Participation = 52 Weeks SCREENING LEAD-IN PERIOD: OPEN LABEL TREATMENT SWITCHING MODULE: DOUBLE BLIND TREATMENT OPTIONAL EXTENSION PHASE: OPEN LABEL TREATMENT STAGE-1: OP
Slide 56: AVT02: Competitive Landscape Overview
AVT02: Competitive Landscape Overview ▪ AVT02 is one of the Product information US Competitive Landscape EU Competitive Landscape only biosimilars to Program Manufacturer Strength Marketer Approval Status Interchangeability Marketer Approval Status high concentration (6) ® AVT02 Alvotech 100mg / mL
Slide 57: 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 58: AVT04: Competitive Landscape Overview
AVT04: Competitive Landscape Overview Product information US EU ▪ AVT04 is one of few known SP2/0 cell line based program Developer Development Status Commercial Partner Program Commercial Partner ▪ No publicly disclosed FDA/EMA biosimilar submissions to date AVT04 Alvotech P3 (EU) Teva Stada ▪ Some
Slide 59: 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 60: Appendix: CCHT Joint Venture
Avalvotech APPENDIX CCHT JOINT VENTURE
Slide 61: 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 62: 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
Slide 63: 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 64: 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