Repligen Corporation · NASDAQ:RGEN

Repligen — Investor Day (September 2022)

73 slides from Repligen's investor day presentation, Sep 20, 2022

  1. Slide 1: Investor Day 2022

    Investor Day 2022 Nasdaq MarketSite September 20, 2022 1

  2. Slide 2: Introductions: Our Team

    Introductions: Our Team Gautam Choudhary Tony Hunt Jim Bylund SVP Systems and President and CEO COO Automation Vikas Gupta VP and GM, Christine Gebski Downstream Bioprocessing and Craig Harrison SVP Filtration and Chromatography Gene Therapy SVP Analytics Ralf Kuriyel Kola Otitoju SVP Research & SVP

  3. Slide 3: Agenda

    Agenda Introduction Sondra Newman 8:20 am Company Overview Tony Hunt 8:30 am Upstream/Downstream Solutions & Systems Christine Gebski 8:50 am Gautam Choudhary Fluid Management: Connecting Unit Operations Jim Bylund 9:30 am ❖ Break 9:45 am R&D: Delivering on Innovation Ralf Kuriyel 9:55 am Cell & Gen

  4. Slide 4: Safe Harbor / Non-GAAP Financial Measures

    Safe Harbor / Non-GAAP Financial Measures This presentation contains forward-looking statements within the meaning of the federal securities laws. Statements in this presentation which are not strictly historical statements including, without limitation, express or implied statements or guidance reg

  5. Slide 5: Company Overview

    a » Company Overview Tony Hunt t) REPLIGEN

  6. Slide 6: What you will hear today

    What you will hear today Repligen activities to sustain above-market growth Enabling efficiency with Expanding into Evolving disruptive technologies emerging modalities our businesses o Enabling significant o Cell and gene therapy (AAV, o Winning in improvements and efficiencies Lenti) Upstream/Down

  7. Slide 7: Execution on our goals over the last 5 years (2017-2022e)

    Execution on our goals over the last 5 years (2017-2022e) “Inspiring Advances in Bioprocessing” 275+ Strong Commercial team 41% 8 35% 8 5-year M&A deals 3-year Disruptive ~65/35 CAGR since 2017 Gene therapy technology CAGR Clinical / launches Commercial +36% (excludes COVID-based since 2017 ratio ex

  8. Slide 8: Strong revenue growth driven by innovation and portfolio expansion

    Strong revenue growth driven by innovation and portfolio expansion Analytics $48M Chroma 7% Chroma $91M Proteins $36M 14% 2017 $54M 2021 26% 48% 32% Filtration 38% $141M 4-year avg. annual Proteins $671M $404M Revenue overall organic Revenue 60% growth $124M CAGR 18% Filtration $49M 35% Long life-cy

  9. Slide 9: Creating value for shareholders

    Creating value for shareholders Delivered strong 2017-2022e Revenue and Adj. EPS growth; On track for strong 2022 $900 41% 5.5x 5-year increase in $3.13-$3.20 $3.50 H1 2022 Highlights Revenue CAGR Adj. EPS $3.06 $800 $3.00 $700 $790- $810 $2.50 o Record revenue $414M incl. $88M COVID-related $671 Re

  10. Slide 10: Market Landscape

    a » Market Landscape t) REPLIGEN

  11. Slide 11: Healthy end markets: mAbs and C&GT fuel our growth

    Healthy end markets: mAbs and C&GT fuel our growth New ~$150B Market 2021 >125 >800 approvals and growing U.S. FDA Approvals Candidates Phase I-III incl. 23 Biosimilars biosimilars Monoclonal Growing at >10% pipeline Antibodies annually >1,500 Active clinical trials >$5B 12 >500 Emerging Market 2021

  12. Slide 12: Biosimilar mAbs market acceleration – opportunities across our broad portfolio

    Biosimilar mAbs market acceleration – opportunities across our broad portfolio Global Biosimilar Market Outlook1 “Top 6” mAbs with launched biosimilars US FDA 2021 approved $20B $30B $60B Sales biosimilars 2022 2025 2030 $20.7B 71 Looking Ahead: 97 programs in development2 $3.6B 1 Humira biosimilars

  13. Slide 13: We see the evolution of mRNA as a major new modality and market driver

    We see the evolution of mRNA as a major new modality and market driver COVID demand – including from the leading vax manufacturers – provides an mRNA entry point for Repligen Leading COVID vaccine developers are advancing the greatest number of 40+ programs $470M in mRNA-based vax, 25+ programs ~20

  14. Slide 14: Our Addressable Market and How We are Winning

    Our Addressable Market and How We are Winning 14

  15. Slide 15: Expanding addressable market now >$8B; $22B total market

    Expanding addressable market now >$8B; $22B total market Taking share, creating new markets, and delivering industry-leading revenue growth PROTEINS & AFFINITY RESINS Our market share: ~6% $1.9B Our 3-year CAGR (2018-2021): >30% 24% $4.3B FILTRATION 53% Our market share: ~9% $8B Our 3-year CAGR (201

  16. Slide 16: We have the right blueprint for continued success

    We have the right blueprint for continued success Strategic M&A o Technology focus o Rapid growth of acquired companies R&D Innovation o First-to-market product introductions o Market-leading technologies o Collaborations with industry leaders in key growth areas Operational Excellence o Capacity ex

  17. Slide 17: Creation of value through strategic acquisitions

    Creation of value through strategic acquisitions Technology differentiation, potential for growth above historical, attractive margins, near term accretion 2014 2016 2017 2019 2020 2021 2022e Filtration $60M (Cumulative pro forma acquisition year revenues) ~$500M 8X Analytics 2X $26M ~$60M Fluid Man

  18. Slide 18: R&D fuels first-to-market innovation and technology leadership

    R&D fuels first-to-market innovation and technology leadership Technology Leadership First-to-Market Advantage Key Partnerships o Perfusion & process intensification o Navigo Proteins o Harvest/clarification 8 o Pre-packed columns High performance ligands disruptive o Ecolab (Purolite) o Viral vecto

  19. Slide 19: Incredibly productive 2021 for R&D – Drives future revenue growth

    Incredibly productive 2021 for R&D – Drives future revenue growth Our Applications team is successfully seeding new products into the market Filtration Chromatography: Resins, Columns, and Systems Single-use COVID affinity XCell ATF® 1 resin KRM™ Chromatography 12 Systems products (¼” & ½”) XCell™ N

  20. Slide 20: DRS Daylight Solutions (Daylight)

    DRS Daylight Solutions (Daylight) Game-changing technology Bioprocessing for bioprocessing: Culpeo® applications o Leader in Quantum Cascade Laser o Nucleic acid quantification mid-IR (QCL-IR) technology o Stability studies o Proven reliability in defense & o Protein aggregation aerospace industries

  21. Slide 21: 15-year strategic partnership with Daylight

    15-year strategic partnership with Daylight Bringing advanced mid-IR laser technology to the bioprocessing market Combines the power of two Innovators Strengthens Repligen PAT position o Complementary to C Technologies o Adds mid-IR (higher sensitivity QCL-IR) to UV o Experts in QCL with o Bioproces

  22. Slide 22: Capacity investments driving improved lead times

    Capacity investments driving improved lead times o Providing best-in-class 3x lead times and Capacity customer satisfaction investment o Driving business continuity through OPUS® PPC KrosFlo® Systems Spectrum® HF filters ~$70M multi-site in 2020/2021 manufacturing o Securing the supply chain 4x 7x 9

  23. Slide 23: Growing our presence in the world of bioprocessing

    Growing our presence in the world of bioprocessing North America Europe 41% 40% $671M 2021 Revenue APAC 19% Field Sales Applications 44% and Service 41% >275 Commercial Team Manufacturing Sites Corporate Headquarters (Waltham MA) Customer Service Asia-Pacific Commercial Offices 15% 23

  24. Slide 24: Advancing our ESG strategy across 4 pillars

    Advancing our ESG strategy across 4 pillars Committed to Sustainability Nov. 2021: 2022: Focused on DE&I and Recycle/Reuse/Reduction Programs Runner Up for Best 1st Time Report o Progressing on senior level diversity hiring objectives SASB & GRI Core frameworks o Advancing HBCU and BSCP* relationshi

  25. Slide 25: Well positioned for future growth

    Well positioned for future growth Growth Rates 2022e o Innovation leader in bioprocessing FILTRATION o Expanding total addressable market >$8B 24%-28% o Capturing market share in new modalities CHROMA Setting a new o R&D engine fueling future growth 25%-30% revenue goal: o Expanding manufacturing ca

  26. Slide 26: Upstream | Downstream | Systems

    Upstream | Downstream | Systems Christine Gebski, Gautam Choudhary 26

  27. Slide 27: Strong alignment with industry trends/dynamics

    Strong alignment with industry trends/dynamics ≥85% of pre-commercial product manufacturing now involves near total, single-use systems-based manufacturing1 Market and customer dynamics State of bioprocessing providers Critical success factors o Industry is shifting from COVID o Process intensificat

  28. Slide 28: Setting new standards in biological drug production with single-use solutions

    Setting new standards in biological drug production with single-use solutions mAbs, rProteins, vaccines Workflow TRENDS: Process intensification Fewer steps, smaller footprint Scalability, flexibility, process monitoring XCell ATF® KrosFlo® TFDF® Chromatography Systems Ligands and resins KrosFlo® TF

  29. Slide 29: The industry is focused on process intensification

    The industry is focused on process intensification The move to semi/full continuous is still 3+ years away Batch Process Semi- Full Processing Intensification continuous continuous Today 1-3 years 3-10 years o Focus on max output o Links upstream and per unit operation downstream o Yield gains for m

  30. Slide 30: Repligen is recognized as the leader in process intensification

    Repligen is recognized as the leader in process intensification Net Promoter Score 2022 Survey shows Repligen as #1 in Upstream Intensification XCell ATF® Technology KrosFlo® TFDF® Technology Scaling/adoption and expanding Technology focus consumables Market-leading differentiated technology o ~50%

  31. Slide 31: Addressing the need for improved yield in process intensification

    Addressing the need for improved yield in process intensification Lentivirus production of a Vaccine production in cell culture 31X HEK-293 producer cell line 5X cell 6 increase density in LV 31 (ATF vs. the reference process) 5X viral 5 production Fold increase (x) Normalized output yield 4 3 2 1 0

  32. Slide 32: Expanding our leadership position in process intensification

    Expanding our leadership position in process intensification Enhanced performance through new ATF 8% controllers and TFDF Systems 25% Expanding applications – mAbs, Cell and ATF / TFDF ATF / TFDF Gene Therapy and Plasmids 31% opportunities adoption by 54% by molecule project stage 61% Progress the f

  33. Slide 33: Expanding our presence in downstream processing – with consumables

    Expanding our presence in downstream processing – with consumables Affinity ligands and resins Flat Sheet and Hollow Fiber Filters o Expanding affinity partnerships - Ecolab o Market-leading filtration portfolio o Market launch of AAV resins – more to come! o Expanding applications and funnel o Expa

  34. Slide 34: Downstream adoption increasing

    Downstream adoption increasing Modalities expanding, late-stage opportunities gaining momentum 3,000 OPUS® LS Column shipments 11% 20% 32% 2,000 FS/HF FS/HF opportunities adoption by by molecule 14% project stage 66% 1,000 57% mAbs / rProteins Phase I/II Cell and Gene Therapy Phase III 0 Vaccine Com

  35. Slide 35: Expanding our presence in downstream processing – with Systems

    Expanding our presence in downstream processing – with Systems TFF and Chromatography Systems FlowVPX® Integration o Expanded presence in downstream systems o Advancing PAT in Bioprocessing o High recovery, gentle systems providing maximum yield o Only system capable of measuring protein concentrati

  36. Slide 36: Driving consumables revenue through our Systems

    Driving consumables revenue through our Systems Expanding Systems portfolio to address all modalities Hollow Fiber TFF Systems Downstream KR2i Lab System KMPi System Plex System KPS System KTF System 36

  37. Slide 37: Scalable single-use TFF and Chromatography Systems

    Scalable single-use TFF and Chromatography Systems FS Cassette TFF Systems RS 20 System RS 30 System RS 40 System RS 50System Scalable from product development to manufacturing Chrom Systems KRM10 System KRM20 System KRM30 System KRM40 System 37

  38. Slide 38: Addressing needs of Gene Therapy and mRNA customers with product innovation

    Addressing needs of Gene Therapy and mRNA customers with product innovation When every drop counts KrosFlo® RS 20 TFF System ○ Highly automated ○ Robust ○ Scalable 38

  39. Slide 39: Integrated Systems redesigning bioprocessing

    Integrated Systems redesigning bioprocessing o Precision- engineered high recovery systems o Closed single-use flow paths o PAT-enabled o Intuitive software o Integrated consumables KrosFlo® RS TFF System KRM™ Chromatography System M&A Impact: Security of supply, optimized lead times, Systems integr

  40. Slide 40: Differentiated by state-of-the-art innovation and precision engineering

    Differentiated by state-of-the-art innovation and precision engineering 40

  41. Slide 41: PAT and Real-Time Process Management (RPM™) impacting downstream processing

    PAT and Real-Time Process Management (RPM™) impacting downstream processing Integrating FlowVPX for high concentration mAbs Final concentration step targets ~200mg/ml, short processing window Jay West, Single-use program BMS FlowVPX® enables PAT “Integration of FlowVPX will provide for in-line sampl

  42. Slide 42: Systems now fully integrated with Repligen consumables across modalities

    Systems now fully integrated with Repligen consumables across modalities Systems portfolio Addressing single-use PAT integration a expanding customer needs differentiator Linked to Repligen Addressing needs across Tie in with Fluid consumables all modalities Management portfolio 42

  43. Slide 43: Fluid Management

    Fluid Management Jim Bylund 43

  44. Slide 44: What is Fluid Management?

    What is Fluid Management? Cell culture Clarification Purification UF/DF Formulation Bag organizer Flow Path Mixer Holding Holding Tubing vessel vessel Flow Sterile filters Bags Valves, tube Totes, carts, Flow Path Tubing and line sets reservoirs, Path Reservoir storage Single-use solutions that conn

  45. Slide 45: Building a Fluid Management division - $50M in 2022

    Building a Fluid Management division - $50M in 2022 Phase 1: Acquire Technology Phase 2: Build the Division Phase 3: Expand Presence in FM 2020-2021 Today Key components in-house Execution Phase Tubing Tubing, bottles, fittings Molding Assembly centers Bottles Molds Hopkinton and Ireland Fabrication

  46. Slide 46: Dual manufacturing sites are critical to success

    Dual manufacturing sites are critical to success Hopkinton, MA Waterford, Ireland ~32,000 sq. ft. ~33,000 sq. ft. Assurance Quality of Supply Service 46

  47. Slide 47: Repeatable value to be realized through systems consumables

    Repeatable value to be realized through systems consumables Flow path solutions unique for Repligen Systems Revenue ramp for Fluid Management ($ Millions) // 2021 2022e 2027 goal 47

  48. Slide 48: Fluid Management business rapidly accelerating

    Fluid Management business rapidly accelerating New business Rapidly growing and within Repligen expanding Fast turn-around time Leverages growing Provides another focused on customized installed base recurring consumable solutions of Systems revenue stream 48

  49. Slide 49: Research and Development

    Research and Development Ralf Kuriyel 49

  50. Slide 50: Our approach to R&D

    Our approach to R&D Continuous innovation so latest manufacturing challenges are addressed Making significant improvements in biomanufacturing to address current challenges o Increasing yields and titers through process intensification o Reducing bioprocessing steps - eliminating unit operations Sup

  51. Slide 51: Improving biomanufacturing through technology platforms

    Improving biomanufacturing through technology platforms High performance Systems with Upstream intensification Affinity purification process systems integrated analytics o Increase titers and yields o Accelerate process o Reduce number of o Accurate adaptive control – development times through produ

  52. Slide 52: Focused on R&D solutions to address the greatest needs of our customers

    Focused on R&D solutions to address the greatest needs of our customers Customer Protein aggregation In-line process Need to connect Improving yields in pain points / during antibody monitoring and simplify upstream processing opportunities production and control disparate units Repligen response Vi

  53. Slide 53: N-1 process intensification mainstreamed

    N-1 process intensification mainstreamed Process Development Large-scale manufacturing Development of an intensified fed-batch production platform with doubled titers Seed stage (N-1) to enable using N-1 perfusion seed for cell culture inoculation of 15,000L bioreactors manufacturing1 30% reduction

  54. Slide 54: TFDF® - Technology for Harvest Clarification & process intensification

    TFDF® - Technology for Harvest Clarification & process intensification Displacing traditional depth filtration Tangential Flow Depth Filtration (TFDF) 2 Normalized vector yield o Multiple harvests 1.5 Harvest 2 o 80% higher yield 1 than single harvest Harvest 1 0.5 o Continuous operation 0 Bioreacto

  55. Slide 55: Game changer: integrating real-time analytics into Systems

    Game changer: integrating real-time analytics into Systems 55

  56. Slide 56: Expanding into new modalities through Gene Therapy Applications Center

    Expanding into new modalities through Gene Therapy Applications Center Intensification and Clarification of Viral Vector Production with Integrated Perfusion Platforms Advancing Manufacture of Cell and Gene Therapies VII San Diego CA, Feb 6-10 2022 OPUS® RoboColumn® and AVIPure® AAV Resins for Impro

  57. Slide 57: Moving towards an integrated product offering

    Moving towards an integrated product offering From unit solutions: Moving to integrated solutions: Unit + Unit + Unit + N-1/Perfusion ATF SU Flow Paths Systems Controllers and Clarification TFDF Purification OPUS PD, OPUS LS Affinity Resins Plus intelligent + Process Systems Analytics Concentration

  58. Slide 58: Cell and Gene Therapy

    Cell and Gene Therapy Vikas Gupta 58

  59. Slide 59: Viral vector demand is increasing, driving greater cell culture volumes

    Viral vector demand is increasing, driving greater cell culture volumes Reproducible and scalable processes are critical to commercial success of next-generation gene therapy Disease Indications Therapy Type Evolving to: Retinal Dystrophy AAV indications with larger patient Spinal Muscular Atrophy A

  60. Slide 60: Large pipeline of gene, cell and RNA therapies (including preclinical)

    Large pipeline of gene, cell and RNA therapies (including preclinical) We have many opportunities to embed Repligen products early 13% 22% >3,600 16% Repligen Pipeline gene therapy therapies by 56% revenue mix 22% category1 H1 2022 71% Gene therapies* Gene therapies* RNA-based (Non-viral vector) RNA

  61. Slide 61: Viral vector platforms employed in gene therapy clinical trials

    Viral vector platforms employed in gene therapy clinical trials Repligen technologies are agnostic to viral vector platform 3% AV LV 2% 25% 35% Revenue by Vector 62% H1 2022 AAV 73% AAV LV Adenovirus (Developers Only) Our goal: Embed Repligen technology early in viral vector platform development 61

  62. Slide 62: Demand from CDMOs and developers drives majority of our C&GT revenue

    Demand from CDMOs and developers drives majority of our C&GT revenue $2B addressable market in 2022, growing at 25%; Repligen estimated growth 30%+ C&GT Revenue C&GT Revenue mix $80 $70 35% 5% 3-year C&GT By CDMO $60 CAGR (2019-2022e) 49% customer Developer 46% ($ Millions) $50 type Academia $40 40%

  63. Slide 63: Repligen is solving pain points in viral vector manufacturing

    Repligen is solving pain points in viral vector manufacturing Limited upstream productivity and scalability Low downstream yield Scale-up challenges Pain points 1 2 3 (adherent cell culture, transient expression) of recovery downstream Repligen 3X + productivity 2X downstream yield Improved process

  64. Slide 64: Addressing the upstream titer challenge

    1 Addressing the upstream titer challenge KrosFlo® TFDF® improves upstream productivity and scalability 8.4 Intensified Upstream Cell Growth, Harvest and Clarification 4.7 3.8 Plasmid Transfection 3X 1.2 increase in AAV VG/cell (x 1E4) Total VG produced/L bioreactor (x 1E14) with TFDF Batch - TFN @2

  65. Slide 65: Addressing downstream yield and scale-up challenges

    2 3 Addressing downstream yield and scale-up challenges Repligen KRM™ Chromatography System maximizes product recovery Major C&GT CDMO o Significant improvement in product recovery o Maintained process steps and parameters during scale-up AAV 9 serotype Bench scale Production scale 5 ml 500 L KRM™ C

  66. Slide 66: Staying at the forefront of technology

    Staying at the forefront of technology Generating applications data at pace with the latest developments in gene therapy GTM 2.0 31X LV YIELD Suspension continuous cell culture 2022 - Gene therapy applications lab Stable expression >10X YIELD 2022 Suspension continuous cell culture Transient express

  67. Slide 67: mRNA programs are accelerating and diversifying; future market driver

    mRNA programs are accelerating and diversifying; future market driver COVID demand – including from the leading vax manufacturers – provides an mRNA entry point for Repligen Leading COVID vaccine developers are advancing Clinical trials of the greatest number of non-COVID mRNA programs 43% RNA medic

  68. Slide 68: mRNA market gaining strength – Strong product fit with Repligen portfolio

    mRNA market gaining strength – Strong product fit with Repligen portfolio Repligen mRNA business growing at 35%+ Complex workflow, Low purification Pain points 1 2 3 Scale-up challenges limited process knowledge recovery Repligen Technologies enabling scalability Technologies enabling process develo

  69. Slide 69: How we win in Gene Therapy and related modalities

    How we win in Gene Therapy and related modalities Addressing pain points Best-in-class Systems: Single-use flexibility, across workflow; product recovery, proven scalability improving titer and low hold up volumes yields Continuous innovation: Technology portability: Fluid Management disruptive prod

  70. Slide 70: Thank you

    Thank you www.repligen.com © Repligen Corporation. All rights reserved. The trademarks mentioned herein are the property of Repligen Corporation and/or its affiliate(s) or their respective owners. 70

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  72. Slide 72: Appendix

    ( nppendix — REPLIGEN 72

  73. Slide 73: 2022 Guidance reconciliation

    2022 Guidance reconciliation Net income and net income per share REPLIGEN CORPORATION REPLIGEN CORPORATION RECONCILIATION OF GAAP NET INCOME PER SHARE GUIDANCE TO RECONCILIATION OF GAAP NET INCOME GUIDANCE TO ADJUSTED (NON-GAAP NET INCOME GUIDANCE) ADJUSTED (NON-GAAP) NET INCOME PER SHARE GUIDANCE (

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