Alvotech · NASDAQ:ALVO

Alvotech — SPAC Merger (March 2022)

84 slides from Alvotech's SPAC merger presentation, Mar 23, 2022

  1. Slide 1: Analyst Day March 2022

    Filed by Alvotech Lux Holdings S.A.S. (Commission File No. 333-261773) Pursuant to Rule 425 under the Securities Act of 1933 And Deemed Filed pursuant to Rule 14a-12 under the Securities Exchange Act of 1934 Subject Company: Oaktree Acquisition Corp. II ANALYST DAY MARCH 2022

  2. Slide 2: Important 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

  3. 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

  4. Slide 4: Today's Agenda

    Today’s Agenda Robert Wessman Zaid Pardesi Opening Remarks & Introduction to Oaktree and Alvotech Alvotech founder & Chief Financial 09:00AM – 09:15AM Chairman Officer and Head of M&A of OACB Mark Levick Ming Li Biosimilars Background and Opportunity 09:15AM – 09:40AM Chief Executive Chief Strategy

  5. Slide 5: Alvotech: Compelling Platform Providing 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 PROVEN LEADERSHIP TEAM marketing authorization for 17 biosimilars and 8 originator biologics 1 globally • Significant acceleration o

  6. Slide 6: 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

  7. Slide 7: This is Alvotech

    This is Alvotech 7

  8. Slide 8: Growth Platform Ready To Be Deployed Having Been Built Over 9 Years

    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

  9. Slide 9: Alvotech at a Glance

    Alvotech Partners Alvotech at a Glance – Full-Scale, Pure-play Biosimilar Developer and Manufacturer with Global Commercial Capabilities A 8 pipeline candidates with › Purpose-built and in-house R&D platform, solely focused $85Bn+ sales potential on the development of biosimilar products R&D ~720 pe

  10. Slide 10: 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

  11. 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

  12. Slide 12: Significant Market Opportunity

    SIGNIFICANT MARKET OPPORTUNITY

  13. Slide 13: Opportune Timing for Industry and Alvotech

    Opportune Timing for Industry and Alvotech • Established regulatory pathway to market including interchangeability for the U.S. market Biosimilar • Significant number of biologic LoEs on the Market horizon • Global biosimilars market estimated to grow to Evolution $79 billion in 2026 (17% CAGR from

  14. Slide 14: Biosimilar Development Holds Less Risk and Complexity than Originator Biologics

    Biosimilar Development Holds Less Risk and Complexity than Originator Biologics, and Significantly More Complexity and Barriers to Entry Than Generics Originator Biologics Biosimilars Generics (1) (2) (3) (5) Development Costs $2.6Bn $100-200MM $1-2MM (2) (3) (6) PoS Low Moderate to high High Develo

  15. Slide 15: 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 ($

  16. Slide 16: 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

  17. Slide 17: US Biosimilar Regulatory Pathway has Matured with 30+ Approved Products

    US Biosimilar Regulatory Pathway has Matured with 30+ Approved Products ~Early 2000s 2014 March 2020 2018 First biosimilar First biosimilar filing Deadline to transition Launched Biosimilars Key Highlights programs started utilizing the certain biologics Action Plan abbreviated applications from NDA

  18. Slide 18: US Biosimilar Market Showing Rapid Uptake With Modest Price Erosion

    US Biosimilar Market Showing Rapid Uptake With Modest Price Erosion (1) (2) Biosimilar Uptake of Selected Products in US Market Originator and Biosimilar WAC Price Difference in US Total Biosimilar share (%) (as of October 2021) Percentage difference in average WAC of biosimilars and originator prod

  19. Slide 19: 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 (1) authorization by the prescribing physician ‒ Pharmacists can substitute the interchangeable biosimilar for the originator without approval ‒ Interchangea

  20. Slide 20: EU Has Pioneered the Regulation of Biosimilars

    EU Has Pioneered the Regulation of Biosimilars and Has 80+ Approved Biosimilars Early 2000s 2005 2007 2015 First biosimilar EMA publishes EMA provides EMA provides revised Key Highlights programs guidelines on comparability general guidelines on started biosimilars guidelines for biosimilars and rev

  21. Slide 21: EU Biosimilar Market Overview

    EU Biosimilar Market Overview (1) Biosimilar Uptake of Selected Products in EU Market EU Market Key Trends Biosimilar market share based on Standard Units including all available dosage strengths (as of Nov 2021) • Europe was an early adopter of biosimilars and is the most mature biosimilar market g

  22. Slide 22: Competing Priorities Created an Opportunity for Biosimilar Focused Companies

    Competing Priorities for Players, has Created an Opportunity for Biosimilar Focused Companies to Capture Growth Limited/Reduced Biosimilar Emphasis Pure-Play Key Highlights Biosimilar Focus within Broader Portfolio Biosimilar Focus ▪ Requires scale to play in biosimilars ▪ Biosimilar portfolios have

  23. Slide 23: Benefits of a Core Focus Strategy on Biosimilars

    Benefits of a Core Focus Strategy on Biosimilars Aligned Corporate Purpose ✓ › Mission driven purpose motivates and attracts high quality team › Provides pure-play exposure in a fast-growing market with limited true comps › Provides unique ESG characteristics Nimble and Adaptable ✓ › Flexibility to

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  25. Slide 25: Purpose-Built Biosimilar Platform

    PURPOSE-BUILT BIOSIMILAR PLATFORM

  26. Slide 26: 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

  27. Slide 27: 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

  28. Slide 28: 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

  29. Slide 29: 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

  30. Slide 30: Reykjavik Facility Expansion

    Reykjavik Facility Existing Facility Expansion 2 2 ~140,000 ft ~135,000 ft 2 • Drug product expansion and redundancy (~20,000ft ) • Two “ballroom” drug substance areas with fed batch and perfusion 2 capabilities (~30,000ft ) 2 • Warehousing Expansion (~10,000ft ) 2 • Drug Product fill finish capacit

  31. Slide 31: Global Commercial Partner Network

    GLOBAL COMMERCIAL PARTNER NETWORK

  32. Slide 32: 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

  33. Slide 33: Benefits of Global Commercial Partnerships

    Benefits of Global Commercial Partnerships Accelerated Sales through Local Expertise › Commercial partners have established distribution networks, enabling rapid commercialization › Go-to-market strategy varies significantly across global markets; local know-how and brand awareness mitigates launch

  34. Slide 34: Global Reach Through Partnerships

    Global Reach Through Partnerships 34

  35. Slide 35: 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) 2021A Licensed Alvotech Geographic 2021A Licensed Alvotech Geographic Partner Partner Partner Rev Products Rights Partner Rev Products Rights Australia, New (3) Zealand, South $2.8Bn 5 Africa US $15.9B

  36. Slide 36: Key Aspects of Our Partnership Model

    Key Aspects of Our Partnership Model Mutually Beneficial Structure › Commercial partnership agreements are strategic and mutually exclusive with long-term commitments for multiple products Scope of Work Leverages Core Capabilities › Partners are responsible for all commercialization activities and r

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  38. Slide 38: Diverse Pipeline With Significant TAM

    DIVERSE PIPELINE WITH SIGNIFICANT TAM

  39. Slide 39: Rigorous Approach To 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 Differentiation accordingly Commercial › Portfolio offerings and brand aw

  40. Slide 40: 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 $86.2Bn $3.6Bn $3.7Bn $6.7Bn Future Growth $10.3Bn Market growth $10.8Bn Additional internal $21.2Bn programs - platfor

  41. Slide 41: AVT02: Adalimumab Market Overview

    AVT02: Adalimumab Market Overview Humira® TRx by Concentration Market Context ▪ Initial market for Humira was solely in the low Alvotech concentration is one of the few players addressing ▪ High concentration has aided the recent ~83%+ of market commercial success of the product o Improved pharmacok

  42. Slide 42: AVT02: Multiple Points Of Differentiation

    AVT02: Multiple Points Of Differentiation, Including High Concentration And Potential Interchangeability Program Status Alvotech Strategy ® Branded Biologic Humira • High concentration: One of the few known programs in (Generic Name) (Adalimumab) development with the high concentration (100mg/ml), ®

  43. Slide 43: AVT02: Devices Used in Chronic Therapies are Important

    AVT02: Devices Used in Chronic Therapies are Important Designed with Ergonomic Use in Mind Sturdy, oval design, and latex-free, solid Visual indicator when the construction for a substantial feel in hand injection is complete Soft, wide, textured grip for easy handling Lock-out feature after injecti

  44. Slide 44: AVT02: Competitive Landscape Overview

    AVT02: Competitive Landscape Overview Product information US Biosimilar Launch Status Interchangeability Manufacturer / Expected Launch Switching Program Approval Status Timing / Notes Marketer Date Study • Aim to be the first interchangeable, high concentration product at launch Alvotech / (1) (1)

  45. Slide 45: AVT04: Stelara is a Rapidly Growing Product Ripe For Biosimilar Entry

    AVT04: Stelara® is a Rapidly Growing Product Ripe For Biosimilar Entry Due To High Price Point (1) Historical and Projected Stelara® Sales ($Bn) Market Context 10.0 (2)▪ Stelara continues to increase revenue with double digit Stelara® Annual Cost of Treatment: $144,000 $9.4 YoY growth 9.0 nd rd ▪ At

  46. Slide 46: AVT04: A Highly Differentiated Approach to a Stelara Biosimilar

    AVT04: A Highly Differentiated Approach to a Stelara® Biosimilar Program Status Alvotech Strategy ® Branded Biologic Stelara • SP2/0 Host Line: Manufactured using same host cell line (Generic Name) (Ustekinumab) as Stelara® o SP2/0 host cell line allows for more efficient Originator Johnson & Johnso

  47. Slide 47: AVT04: Competitive Landscape Overview

    AVT04: Competitive Landscape Overview ▪ AVT04 is one of few known SP2/0 cell line based programs Product information US EU o SP2/0 cell line facilitates higher levels of sialic acid on Commercial Program Developer Commercial Partner the monoclonal antibody; high levels of sialic acid are Partner ass

  48. Slide 48: AVT03: Denosumab Market Overview

    AVT03: Denosumab Market Overview Historical and Projected Prolia® and XGEVA® Sales ($Bn) Market Context ▪ Prolia and Xgeva continue to experience attractive sales $5.8 growth as well as favorable pricing dynamics ’17A-’21A CAGR: 11% ▪ Growth for these products is expected to continue as the $5.2 $5.

  49. Slide 49: AVT03: Novel Formulation for Denosumab

    AVT03: Novel Formulation for Denosumab Program Status Alvotech Strategy Branded Biologic Prolia® and XGEVA® • Production consistency: Both the reference product as (Generic Name) (Denosumab) well as our proposed biosimilar AVT03, are produced in recombinant Chinese hamster ovary cells Originator Amg

  50. Slide 50: AVT05: Golimumab Market Overview

    AVT05: Golimumab Market Overview Historical and Projected Simponi® Sales ($Bn) Market Context ▪ Simponi (Golimumab) is an anti-TNF, the same class of ’17A-’21A CAGR: 5% therapeutic as Humira $3.6 $3.5 ▪ Simponi has a once-monthly formulation which is a $3.4 $3.3 differentiator among other anti-TNFs

  51. Slide 51: AVT05: Only Known SP2/0 Cell-Line Based Program

    AVT05: Only Known SP2/0 Cell-Line Based Program Alvotech Program Program Status AVT05 Alvotech Strategy Branded Biologic Simponi® • Interchangeability: Only publicly disclosed golimumab (Generic Name) (Golimumab) biosimilar program to be seeking the interchangeability designation Originator Johnson

  52. Slide 52: AVT23: BiosanaPharma Agreement Overview

    AVT23: 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, sm

  53. Slide 53: AVT23: Omalizumab Market Overview

    AVT23: Omalizumab Market Overview Historical and Projected Xolair® Sales ($Bn) Market Context ▪ High physician familiarity and levels of experience with ’17A-’21A CAGR: 7% Xolair’s biologic class (e.g. IgE binding) $3.6 $3.3▪ Remains competitive against new entrants; with $3.2 reported US growth of

  54. Slide 54: AVT23: Attractive Manufacturing Process for Omalizumab

    AVT23: Attractive Manufacturing Process for Omalizumab Alvotech Program Program StatusXolair® Alvotech Strategy ® Branded Biologic Xolair ▪ Leverages the advancements made by Biosana utilizing (Generic Name) (Omalizumab) their proprietary 3C manufacturing technology o Highly efficient process with h

  55. Slide 55: AVT06: Aflibercept Market Overview

    AVT06: Aflibercept Market Overview Historical and Projected Eylea® Sales ($Bn) Market Context ▪ Eylea continues to be a leading ophthalmology product, ’17A-’21A CAGR: 12% with attractive market share across all approved $9.9 indications ▪ Full year 2021 Eylea US net sales increased 17% versus $8.4 2

  56. Slide 56: AVT06: Compelling Formulation for Eylea (Aflibercept)

    ® AVT06: Compelling Formulation for Eylea (Aflibercept) Alvotech Program Program Status AVT06 Alvotech Strategy ® Branded Biologic Eylea • Vial and PFS offering in development: Matching the (Generic Name) (Aflibercept) innovator with both of the dosage forms available in the market Originator Regene

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  58. Slide 58: Attractive Financial Profile

    ATTRACTIVE FINANCIAL PROFILE

  59. Slide 59: 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

  60. Slide 60: Attractive Revenue Potential As Products Commercialize

    Attractive Revenue Potential As Products Commercialize Risk Adjusted Revenue Commentary $ in millions 2022-2025 • 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 Pre-

  61. Slide 61: 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

  62. Slide 62: Financial Guidance Summary (Risk Adjusted)

    Financial Guidance Summary (Risk Adjusted) 2021A (unaudited) 2022E 2025E 2025E – 2030E $ millions (1) (2) Product Revenue $0 $25 – $75 85% of total revenue (1) (3) 15% of total revenue Milestone Revenue $40 $60 – $80 (Cumulative $470MM+ from ’23E – ‘25E) High single-digit (1) Total Alvotech Revenue

  63. Slide 63: Additional Opportunities Beyond The Financial Forecast

    Additional Opportunities Beyond The Financial Forecast Conservative Baseline Projections Omit Numerous Opportunities For Upside Potential upside Earnings Revenue from In-licensing of driven by further contribution additional R&D external differentiation from China joint programs as programs from ven

  64. Slide 64: Transaction Summary

    alvotech ij i TRANSACTION SUMMARY

  65. Slide 65: 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

  66. Slide 66: 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 Subsidiary Primary Biosimilar Focus ûPPPP Biosimilars R&D PPPPP Biosimilar Manufacturing ûPPPP Gl

  67. Slide 67: 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) 86.2 69.9 67.2 56.5 56.2 (2) 21.3 (6) Total Enterprise Value ($Bn) $1.0 $5.8 $2.3 $19.0 $39.3 (7) EV / NTM EBITDA N/M 17.5x N/A 22.3x 60.3x ’22E – ’25E Revenue CAGR 43% N/A >70% 7% 17%

  68. Slide 68: Recent Biosimilar Transactions Support Valuation

    Recent Biosimilar Transactions Support Valuation Samsung Biologics / Biogen Biosimilar JV Stake 17.0x ▪ Samsung was captive buyer through the ~50-50 JV with Biogen, limiting ability to extrapolate implied valuation/multiple ▪ Ongoing commercial relationship for distribution of current products with

  69. Slide 69: 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 $5.8 illustrative current value $4

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  71. Slide 71: 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 71

  72. Slide 72: Appendix: Select Management Team Biographies

    APPENDIX SELECT MANAGEMENT TEAM BIOGRAPHIES

  73. Slide 73: 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

  74. Slide 74: 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

  75. Slide 75: Appendix: Biosimilar Background Information

    APPENDIX BIOSIMILAR BACKGROUND INFORMATION

  76. Slide 76: 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

  77. Slide 77: 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

  78. Slide 78: 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

  79. Slide 79: Appendix: Additional Product Background

    APPENDIX Additional Product Background

  80. Slide 80: 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

  81. Slide 81: AVT02: Successful Switching Study Can Support Interchangeable Designation

    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

  82. Slide 82: Appendix: CCHT Joint Venture

    Avalvotech APPENDIX CCHT JOINT VENTURE

  83. Slide 83: 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

  84. Slide 84: 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

Alvotech — SPAC Merger (March 2022) on 6ix