Maravai Lifesciences Holdings, Inc. · NASDAQ:MRVI
Maravai Lifesciences — Investor Day (January 2022)
74 slides from Maravai Lifesciences's investor day presentation, Jan 28, 2022
Slide 1: Investor R&D Day, January 28th
FRIDAY, JANUARY 28TH 9:00 AM – 12:00 PM PST VIRTUAL ONLY Revised April 2022
Slide 2: Welcome and Opening Remarks
Welcome and Opening Remarks Deb Hart Senior Director, Investor Relations
Slide 3: Forward looking statements and use of non-GAAP financial measures
Forward looking statements and use of non-GAAP financial measures This presentation contains, and our officers and representatives may from time-to-time make, “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. I
Slide 4: Agenda
Agenda 01 Welcome and Opening Remarks Deb Hart, Senior Director, Investor Relations 06 Nucleic Acid Production Overview Brian Neel, Chief Operating Officer, Nucleic Acid Production 02 Maravai: Markets and Opportunity Carl Hull, Chief Executive Officer 07 Q&A Session 03 Panel Discussion on Cell and G
Slide 5: Maravai: Markets and Opportunity
Maravai: Markets and Opportunity Carl Hull Chief Executive Officer
Slide 6: Maravai at a glance
Maravai at a glance TTM TTM ADJUSTED REVENUE1 EBITDA1,2 Customers include the top 20 global biopharmaceutical companies ranked by R&D spend Benefiting from a rapidly building pipeline in RNA therapeutics and vaccines $669M $484M 308% y/y growth ~202% y/y growth Addressing multiple other cell a
Slide 7: We are living in a historic era for life sciences
We are living in a historic era for life sciences Exponential Emergence of increase in volume Explosion in novel therapeutic Acceleration of Unprecedented of basic academic validated targets modalities and therapeutic capital inflows research enabled by new technologies development discovery tools t
Slide 8: We provide enabling solutions from discovery through to commercialization
We provide enabling solutions from discovery through to commercialization Discovery and Research Preclinical Clinical Commercialization Oligonucleotides RNA Capping (CleanCap) Nucleic Acid mRNA Production Plasmid DNA Host Cell Protein Detection Viral Clearance Prediction Biologics Process Related Im
Slide 9: Maravai supplies key technologies to breakthrough end markets
Maravai supplies key technologies to breakthrough end markets END MARKETS CELL AND BIOLOGICS AND MOLECULAR PRIMARY BRAND PRODUCT mRNA VACCINES GENE THERAPY BIOSIMILARS DIAGNOSTICS Nucleic RNA Capping CleanCap CleanCap Acid mRNA mRNA mRNA Production Plasmid DNA Plasmids Plasmids TriLink® Custom Guide
Slide 10: Our markets are attractive and rapidly growing
Our markets are attractive and rapidly growing $4.7B 7% ADDRESSABLE ADDRESSABLE MARKET SIZE (2021)1 MARKET GROWTH (2021-2024 CAGR) $15.3B 8% TOTAL MARKET SIZE MARKET GROWTH (2021) (2021-2024 CAGR) 10 1. Includes products, use cases and customer types relevant to Maravai
Slide 11: Pipelines of all novel modalities are increasing significantly
Pipelines of all novel modalities are increasing significantly Product Pipeline Growth1 (%) 2019–2021 Key Development Areas COVID-19 vaccines, mRNA 182% other vaccines and oncology Solid and hematologic tumor oncology Cell Therapy 71% and rare diseases Rare genetic-based diseases Gene Therapy 44% an
Slide 12: COVID-19 pandemic accelerated and validated mRNA vaccine development
COVID-19 pandemic accelerated and validated mRNA vaccine development COVID-19 Currently Proof of principle established at unprecedented commercial scale Many companies mRNA modality Prior vaccine investing in mRNA Supply chain has delivers high-speed modalities did not meet vaccine development overc
Slide 13: mRNA is rapidly expanding beyond COVID-19 vaccines today
mRNA is rapidly expanding beyond COVID-19 vaccines today Broad and Growing mRNA Therapeutic Pipelines Outlook1 Broad Diversity of Multiple Therapeutic Renewed interest in Disease States Modalities developing mRNA vaccines 4 flu vaccines in clinic outside of COVID-19: flu, 50 non-flu vaccines in
Slide 14: Cell and gene therapies are the next big thing
Cell and gene therapies are the “next big thing” for the industry and Maravai IN 20211 586 $9.5B 10 $30B+ companies with an of R&D invested distinct new MARKET FORECAST asset in clinical or product launches GROWTH BY 20241 commercial phase • Gene editing via CRISPR Cas9 and other modalities typicall
Slide 15: Bioproduction of mRNA and cell and gene therapies poses many challenges
Bioproduction of mRNA and cell and gene therapies poses many challenges for the industry CHALLENGES Outsourced Partner Model and Fragmented Supply Chain Small relative Pfizer Vaccine scale of Rapid process bioproduction development Complex raw Evolving 280 components 86 suppliers 19 countries materi
Slide 16: Where we are focused to meet the opportunity ahead
Where we are focused to meet the opportunity ahead Expand Portfolio, Market Leadership and Solutions Focused Investment in R&D Ongoing Investments in Operations, Manufacturing and People Innovate Alongside our Customers 16
Slide 17: Financial flexibility allows us to make organic and inorganic investments
Financial flexibility allows us to make organic and inorganic investments Organic Investments Inorganic Investments Technology innovation Complementary or synergistic capabilities Process engineering Vertical integration of supply chain GMP capacity International expansion Portfolio expansion Enhanc
Slide 18: What you'll learn today
What you’ll learn today 01 02 03 We are playing in the right There is significant opportunity We are building a strong target markets with strong for Maravai to emerge as a foundation for long-term, leadership positions and leading, critical supplier and sustainable growth by investing building our
Slide 19: Panel Discussion: Cell and Gene Therapies
Panel Discussion Cell and Gene Panel Members Therapies • Dr. Mike Mitchell, Skirkanich Assistant Professor of Innovation, Bioengineering, Mitchell Lab, University of Pennsylvania • Dr. Mohamad-Gabriel Alameh, Director of Engineered mRNA and Targeted Nanomedicine Core, Weissman Doreen Pippen (Moderat
Slide 20: Biologics Safety Testing
Biologics Safety Testing Christine Dolan Chief Operating Officer, Biologics Safety Testing Eric Bishop Vice President, R&D, Cygnus Technologies
Slide 21: Our products are used throughout product development and commercialization
Our products are used throughout product development and commercialization Discovery and Research Preclinical Clinical Commercialization Host Cell Protein Detection Viral Clearance Prediction Biologics Process Related Impurity Detection Safety Testing AAE1 and Mass Spectrometry Testing 21 1. AAE = A
Slide 22: Positioned for robust growth in $900M, rapidly growing market
Positioned for robust growth in $900M, rapidly growing market Concentrated on large $~900M, high-growth addressable subsegments of the biological drug product safety market Viral Contamination Growth drivers included COVID-19, growing $350M+ drug pipelines, growth in cell and gene Addressable Mark
Slide 23: Continuous R&D program has yielded gold standard analytics
Continuous R&D program has yielded gold standard analytics for almost every expression platform used in the industry Cygnus Technologies Kits – 23 expression systems with 28 different kits – 23 different process impurities with 50 different kits Protein Therapies Cell and Gene Therapies Vaccines •
Slide 24: Robust product offering spans customer continuum
Robust product offering spans customer continuum Bioprocessing Clinical Manufacturing Validation Quality Control PRECLINICAL TO PHASE 1 CLINICAL PHASE 1 & PHASE 2 PHASE 3 TO BLA COMMERCIAL MANUFACTURING New Protein Detection Clinical Manufacturing Purification Process & Routine Quality Control Analy
Slide 25: We have a strong new product pipeline
We have a strong new product pipeline PG13 – novel expression platform for viral vectors for cell and gene therapies C1 [Myceliophthora thermophila fungi] – novel expression platform for economical production of vaccines and biologics JSR Protein A residual ligand quantification assay Residu
Slide 26: We have a commanding lead in orthogonal services
We have a commanding lead in orthogonal services # Potential High-Risk HCPs PRE F550 F550-1 pI MW Mass Spec Provides Data Rich 1 2 78 kDa glucose regulated protein (BiP, HSPA5) Actin (ACTB) Y Y Y Y Y Y 5.07 5.29 72379.1 41736.7 and Specific Coverage Analysis 3 Aldose reductase related protein 2 Y Y
Slide 27: Identification of the HCP in Final Drug Substance
We have a commanding lead in orthogonal services Identification of the HCP in Final Drug Substance 27
Slide 28: These services make our products sticky
These services make our products “sticky” Customer Buys Customer Customer Cygnus Generic Continues to Approves Kit “Off-the-Shelf” Buy Kit 90-95% Retention HCP ELISA Kit ~100% Retention Customer must prove that this Once the kit/assay is qualified as a generic HCP ELISA Kit is a good “fit-for-purpos
Slide 29: We become an extension of our biopharma customers' critical reagent capabilities
We become an extension of our biopharma customers’ critical reagent capabilities Preclinical Clinical Commercialization Generic Assay Platform Assay Process Specific Assay HCP Ab Assay development services Servicing a particular custom HCP assay throughout the lifetime of the biologic 29
Slide 30: MockV
MockV David Cetlin Senior Director, R&D, Cygnus Technologies
Slide 31: MockV represents a new leg of growth in impurity detection
MockV represents a new leg of growth in impurity detection HCP DNA Leachates Process Impurities Virus ? No kit for measuring virus 31
Slide 32: New technologies are needed for viral clearance
New technologies are needed for viral clearance Viral contaminations during biopharmaceutical production have occurred Regulatory agencies require proof of viral clearance before clinical (pre- phase 1) and commercial (post-phase 3) approval Spiking studies are required to validate – Live mamm
Slide 33: Viral clearance spiking studies are expensive and risky
Viral clearance spiking studies are expensive and there is risk of failure CRO led (on-site at CRO) BSL-2/3 Costs $100K - $500K One month planning + one month for results Increased Risk of Failure Expensive 33
Slide 34: MockV solves these problems
MockV solves these problems Replaces live virus with non-infectious Mock Virus Replaces Particles live virus with non-infectious Mock Virus (MVP) –Particles (MVP) MVPs mimic the physio-chemical characteristics of the – live MVPs virusmimic the physio-chemical characteristics of the live virus – D
Slide 35: Our customers validate the value of our technology
Our customers validate the value of our technology 35
Slide 36: We have a strong new product pipeline
We have a strong new product pipeline 1st Gen MockV MVM Kit MockV RVLP Kit 4th MockV Kit (TBD) (Commercially available since 2019) (anticipated release in Q2 2022) (anticipated release in Q2 2025) 2022 2023 2024 2025 2nd Gen MockV MVM Kit 3rd MockV Kit (TBD) (anticipated release in Q2 2022) (anticip
Slide 37: MockV will be a solid contributor to Biologics Safety Testing revenues
MockV will be a solid contributor to Biologics Safety Testing revenues in the near and long term Addresses an unmet need in the biopharmaceutical process development industry Underlying technology – non-infectious surrogates – is patent protected Rich product pipeline of kits are being develop
Slide 38: Nucleic Acid Production
Nucleic Acid Production Brian Neel Chief Operating Officer, Nucleic Acid Production
Slide 39: Maravai offers critical mRNA technology, products and services
Maravai offers critical mRNA technology, products and services to advance medicine TriLink is a pioneer in the innovation, development, scaleup and manufacturing of mRNA Capture most customers at the development stage and focus on Products & CleanCap technology adoption CleanCap NTP’s Technology
Slide 40: Our services enable and accelerate mRNA discovery and development
Our services enable and accelerate mRNA discovery and development TriLink specializes in advancing our customer mRNA programs into the clinic RUO Services: GMP Services: Over $75M invested in the ug-mg scale gram – 100-gram scale San Diego Wateridge facility 2019-2021 Our new Flanders facility w
Slide 41: We have a rich GMP services pipeline
We have a rich GMP services pipeline Capture most customers at the development stage and focus on CleanCap technology 85% of our 500+ mRNA services customers utilize our proprietary CleanCap technology GMP mRNA CleanCap Customers GMP CleanCap mRNA Customers n = 503 in Clinic n = 153 mRNA Discove
Slide 42: Customer journey: from discovery to commercialization
Customer journey: from discovery to commercialization, our capabilities scale with our customers Phase 1 through to Customer Example: Targets Scale commercialization Customer A 250 10000 Indication: Oncology Technology: Cell 8g Therapy (ex vivo) 200 8000 200 150 6000 Mg of Maravai # of Targets Produ
Slide 43: Customer journey: from discovery to commercialization
Customer journey: from discovery to commercialization, our capabilities scale with our customers Focus end to end API development, scale up and manufacturing WATERIDGE FACILITY 43
Slide 44: Our facilities are designed and engineered to meet demand
Our facilities are designed and engineered to meet demand in both mRNA products and services 119,000 square feet Wateridge CleanCap and NTP innovation and scaleup Facility mRNA services for development and early clinical San Diego, CA 32,000 square feet Flanders CleanCap and NTP manufactur
Slide 45: Continuing product innovation and quality are essential to GMP mRNA customers
Continuing product innovation and quality are essential to our GMP mRNA customers New product and service roadmap to support rapidly expanding industry innovation in mRNA vaccines and therapeutics 2022 2023 2024 Next Gen CleanCap for NATx GMP Next Gen CleanCap for NATx CleanCap GMP CleanCap AG GMP C
Slide 46: Maravai + MyChem strengthens our differentiated position
Maravai + MyChem strengthens our differentiated position in mRNA therapies and vaccines Capabilities accelerate development and production of chemically-synthesized GMP ultra-pure nucleotides for cell and gene therapies MyChem’s ultra pure nucleotides can play a critical role in the development
Slide 47: Q&A Session
Q&A Session
Slide 48: Break
Break
Slide 49: CleanCap and CleanScript Overview
CleanCap and CleanScript Overview Mike Houston Chief Scientific Officer, TriLink BioTechnologies
Slide 50: First-generation CleanCap expresses more protein than ARCA
First-generation CleanCap expresses more protein than ARCA Fluc mRNAs with N1meΨ modified bases were formulated into LNPs by Precision Nanoscience and injected via tail vein into mice by Charles River Labs Representative images from study 1 to compare in vivo activity of cap forms ** n = 5 animals,
Slide 51: Next-generation CleanCap demonstrates higher potency and efficacy
Next-generation CleanCap demonstrates higher potency and efficacy CleanCap 3’OMe used in Pfizer/BioNTech vaccine produces more proteins than first-generation CleanCap Studies comparing in vivo activity of CleanCap analogs CleanCap 3’OMe AG demonstrate that novel CleanCap 3’OMe AG is reproducibly sup
Slide 52: CleanCap Performance in vivo
CleanCap Performance in vivo Fluc mRNAs with N1meΨ modified bases were *** formulated into LNPs by Precision Nanoscience and 2×10 12 * injected via tail vein into mice by Charles River Labs ns to compare in vivo activity of cap forms 1.5×10 12 Integrated Flux 1×10 12 ** 5×10 11 0 G ap A e C A M C R
Slide 53: Novel CleanCap analogs show substantial improvement in vivo
Novel CleanCap analogs show substantial improvement in vivo Modification of cap analogs increases protein expression in vivo 3H 6 9H 12H 24H 3H 6H 9H 12H 24H H Luciferase expression over time Analog 4 Analog 1 + Modification + Modification Analog 1 Analog 4 Representative images from study 2 Analog
Slide 54: N1-me-Ψ Clean Room Grade Performance in vivo
N1-me-Ψ Clean Room Grade Performance in vivo Old N-1081 Process (Li+) Representative images from mouse study New N-1081 Process (Na+) Fluc mRNAs with N1meΨ modified bases chemically synthesized by old and new process were formulated Improved N-1081 modified NTP synthesis performs equal or better in
Slide 55: Streamlined manufacturing process yields higher quality mRNA
Streamlined manufacturing process yields higher quality mRNA Execution of 2 L FLuc mRNA batch using optimized and scalable mRNA production process IVT Purification TFF CleanScript IVT: high yielding and Optimized to increase mRNA High recovery and low low dsRNA quality, remove untailed shear conditi
Slide 56: Optimized process results in higher yields and quality
Optimized process results in higher yields and quality 2 L transcription reaction increases yield and quality CleanScript impacts seen in low dsRNA and high 10 crude yield – dsRNA: 1.69 ng/ug1 – Crude Yield: 10 g/L 8 Purification and TFF result in high recoveries (all 6 Yield greater than 85%) a
Slide 57: Novel modification improves mRNA purity
Novel modification improves mRNA purity By both HPLC and FA, there is a reduction in front impurities and a high-quality mRNA final product – Overlays highlight the removal of a front impurity that is likely the result of a reduction in untailed mRNA Blue: HPLC Post purification Red: FA Post Purif
Slide 58: Proprietary manufacturing process results in lower dsRNA
Proprietary manufacturing process results in lower dsRNA dsRNA reduction was confirmed at different scales across multiple constructs – A very similar reduction was seen during this 2L build using FLuc dsRNA (ng/µg)1 CleanScript IVT CleanScript IVT CleanScript IVT Construct Standard IVT (3 mL) (20
Slide 59: Investing in our Opportunities
Investing in our Opportunities Kevin Herde Executive Vice President and Chief Financial Officer
Slide 60: Strong revenue growth profile generating robust cash flows
Strong revenue growth profile generating robust cash flows Revenue ($M) Adjusted EBITDA ($M)1 $570.8 $422.7 through through Q3’21 $284.1 $62.0 Q3’21 $143.1 $169.2 2019 2020 YTD 2021 2019 2020 YTD 2021 Capital Expenditures ($M) Free Cash Flow ($M)2 $412.7 $27.4 through $19.9 $10.0 Q3’21 through $42.1
Slide 61: Balance sheet provides significant investment capacity
Balance sheet provides significant investment capacity CASH1 LONG-TERM DEBT1 1.1X <0.0X $548 M $545 M GROSS DEBT/ TTM2 EBITDA NET DEBT/ TTM2 EBITDA 1. Cash and long-term debt as of 9/30/21 61 2. TTM EBITDA = Trailing twelve months EBITDA of $487 million
Slide 62: Expanding our facility footprint to support growth plans
Expanding our facility footprint to support near- and mid-term growth plans Nucleic Acid Production Nucleic Acid Production Biologics Safety Testing San Diego, CA Sterling, VA Leland, NC 183,000 square feet (leased) 21,000 square feet (leased) 45,000 square feet (leased) Wateridge Flanders Leland Fa
Slide 63: 2022 Nucleic Acid Production facility investment focused on mRNA optimization
2022 Nucleic Acid Production facility investment focused on mRNA optimization Will focus site on mRNA manufacturing and testing Wateridge Optimize space and teams Facility – mRNA services – Small molecule scale-up and production Critical raw materials Q3:2022 mRNA Technologies and Additional m
Slide 64: Ongoing infrastructure investments in Nucleic Acid Production
Ongoing infrastructure investments in Nucleic Acid Production Wateridge Flanders Facility Facility New Headquarter CleanCap Flanders Lease mRNA Commercial Relocation Production Scale Up Expansion 2018 2019 2020 2021 2022 2023+ Wateridge Lease pDNA Headquarter Office QC CleanCap Facility Expansion Ex
Slide 65: 2022 Biologics Safety Testing facility investment focused on new Leland site
2022 Biologics Safety Testing facility investment focused on new Leland site New 45,000 sq. ft. state-of-the-art facility Leland – Custom designed for growth plan v Facility – 2x square footage of previous facility – Occupancy Q3:2022 Specialized cell culture facilities Mass Significant increa
Slide 66: We will begin to deploy our balance sheet to pursue strategic M&A
We will begin to deploy our balance sheet to pursue strategic M&A opportunities Robust cash flows and strengthening balance sheet provide significant investment capacity – Includes ability to expand debt position if needed Active pipeline of opportunities that mirror the profile of historical Ma
Slide 67: Investing in business infrastructure with mindful ESG considerations
Investing in business infrastructure with mindful ESG considerations Continuing to invest in supply chain relationships, human capital and “doing the right thing” Launch of the Maravai charitable foundation and focus on furthering other ESG initiatives ENVIRONMENTAL BUSINESS MODEL AND COMMUNITY HUMA
Slide 68: Strong, vibrant business and culture
Strong, vibrant business and culture Core Values ESG Initiatives A Great Place to Work Adaptability Environmental Sustainability Open communication Quality mindset Human Capital Working together Business Model and Workplace awareness Innovation Community Relations Reward 68
Slide 69: Closing Remarks
Closing Remarks Carl Hull Chief Executive Officer
Slide 70: In conclusion…
In conclusion… We are playing in the right target markets with strong leadership positions and building our portfolio in high-value areas There is a significant opportunity for Maravai to emerge as a leading, critical supplier and solutions provider in the life sciences industry We are building a st
Slide 71: Q&A Session
Q&A Session
Slide 72: Thank You
THANK YOU
Slide 73: Non-GAAP Reconciliations
Non-GAAP Reconciliations
Slide 74: Non-GAAP Reconciliations
Non-GAAP Reconciliations Adjusted EBITDA Reconiliation in thousands Nine Months Ended Nine Months Ended Twelve Months Ended (1) - Refers to incremental costs incurred to execute and integrate 9/30/2021 9/30/2020 9/30/2021 completed acquisitions. Net income $ 342,140 $ 64,344 $ 356,612 (2) - Refers t
Maravai LifeSciences Holdings — Investor Day (January 2022) on 6ix