Evotec Se · XETR:EVT
Evotec — Investor Day (November 2022)
101 slides from Evotec's investor day presentation, Nov 2, 2022
Slide 1: Paradigm shift in biologics
Paradigm shift in biologics Evotec SE, Capital Markets Day, Redmond, 02 November 2022
Slide 2: Cautionary statement regarding forward-looking statements
Cautionary statement regarding forward-looking statements Information set forth in this presentation contains forward-looking statements, which involve a number of risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, which are often indicat
Slide 3: Let's talk about biologics
Let’s talk about biologics 2nd Capital Markets Day 2022 Werner Lanthaler Matthias Evers Craig Johnstone CEO CBO COO Linda Zuckerman Randal Ketchem Randal Bass John Erickson EVP, Global Head of SVP Discovery & SVP Process Design Veteran industry leader Biotherapeutic Molecular Design Biotherapeutic S
Slide 4: Just – Evotec Biologics
Welcome Just – Evotec Biologics Overview PAGE 4
Slide 5: A highly attractive market with challenges that we will master
A highly attractive market with challenges that we will master Tremendous opportunity to make best molecules Biologics CDMO (external) Unserved indications Lower costs market 7,000 >> US$ 10 bn High prices prohibitive for many CAGR through 2030 Higher 70% probability > 7% of success Underserved regi
Slide 6: Combining critical capabilities to develop medicines that matter and provide access
Combining critical capabilities to develop medicines that matter and provide access Capturing the market requires a paradigm shift Discover mAbs biased for Design and manufacturability down-select highly manufacturable mAbs Continuous manufacturing for Design processes for highest mass highest produ
Slide 7: Leading across all relevant dimensions – A.I./M.L./Automation
Leading across all relevant dimensions – A.I./M.L./Automation Our underlying differentiators Best-in-class facility design Continuous manufacturing A.I./M.L./ High-end process development Automation Latest molecular design & discovery PAGE 7 A.I./M.L. = Artificial Intelligence / Machine Learning
Slide 8: For us A.I. & M.L. are not just buzzwords
For us A.I. & M.L. are not just buzzwords Consistent implementation of A.I./M.L./Automation Lisa Connell-Crowley Randal Ketchem VP Process & Product Design & Seattle Site Head SVP Discovery & Molecular Design Intensifying and shrinking production Before we invested in wet-lab equipment processes are
Slide 9: J.POD – best-in-class biologics facility worldwide
J.POD® – best-in-class biologics facility worldwide Three key points to remember on your tour From To Lower Cost/gram >US$ 150 Cost/gram <US$ 501 costs Large infrastructure footprint Small J.PODs® for continuous manufacturing Billion dollar facilities Facilities that require less CAPEX Higher Scale-
Slide 10: Agenda
Agenda 9.00 – 9.30 am Registration 9.30 – 11.00 am Site Tour – Overview and tour preparation 11.00 am Start of webcast 11.00 – 11.30 am Action Plan 2025 11.30 – 12.15 pm Paradigm shift in biologics – From A.I./M.L.-based discovery to agile commercial manufacturing 12.15 – 12.45 pm Lunch Break 12.45
Slide 11: Action Plan 2025
Action Plan 2025 … more than Just a beginning! PAGE 11
Slide 12: Recap: Our mid-term aspirations at a glance
Recap: Our mid-term aspirations at a glance 2020-2025 estimated key performance indicator goals1 Group revenues Adjusted group EBITDA in € m in € m >100% ≥180% 500.9 >1,000 106.6 ≥300 Unpartnered R&D Co-owned projects2 in € m >100% >100% 46.4 >100 118 >250 PAGE 12 1 As presented H1/2021 2 Incl. equi
Slide 13: Group revenue goal > € 1,000 m by 2025 well within reach
Group revenue goal > € 1,000 m by 2025 well within reach Action Plan 2025 in full swing Group revenue target CAGR 2020-2022e 5-yr CAGR 2020-2025 +20% >15% • Very strong growth of € 501 m group revenues • Shared R&D picking up further momentum despite biotech funding slow-down • Just – Evotec Biologi
Slide 14: Targeting adjusted EBITDA ≥ € 300 m by 2025
Commitment to innovation drives growth & long-term profitability Targeting adjusted EBITDA ≥ € 300 m by 2025 Targeted adjusted EBITDA development1 5-year adj. EBITDA CAGR 2020-2025 to reach >25% due to • Operating leverage of broader platform 5-yr CAGR and expanded manufacturing 2020-2025 • Growth o
Slide 15: A shared economy platform in R&D
Industry at a pivotal moment A shared economy platform in R&D Need for more precision Most drugs still provide benefit in only 50% of patients Our focus areas Need for better disease understanding PanOmics1 Lifetime risk for cancer e.g. 44% in men & iPSC-based Cell Therapies 38% in women Just - Evot
Slide 16: Together for medicines that matter
Together for medicines that matter Game changers More precise medicine PanOmics databases, multi-modality end-to-end shared drug discovery & development A.I./M.L. & technology convergence Latest technologies coming together with drug discovery & development, molecular diagnostics Best talent & right
Slide 17: Opportunity and right to win by focus area within Action Plan 2025
Opportunity and right to win by focus area within Action Plan 2025 What How PanOmics Disease understanding to redefine Leading footprint at scale, esp. in diseases via multi-omics, patient-driven transcriptomics and proteomics, drug design; step-up probabilities of molecular patient databases with d
Slide 18: More balanced revenue mix at slightly higher than anticipated volume by 2025
More balanced revenue mix at slightly higher than anticipated volume by 2025 Differentiating platforms show upside and long-term growth Targeted revenue composition 2025 Contribution with focus areas by 2025 >25% >25% >30% >5% >25% >40% >40% R&D Efficiency Just - Evotec Precision End-to-End PanOmics
Slide 19: Today's focus is on better biologics derived from a new paradigm
Today’s focus is on better biologics derived from a new paradigm The paradigm shift From To Lower Cost/gram >US$ 150 Cost/gram <US$ 501 costs Large infrastructure footprint Small J.PODs® for continuous manufacturing Billion dollar facilities Facilities that require less CAPEX Higher Scale-up No scal
Slide 20: Continuous manufacturing is at the center of our commercial value proposition
Continuous manufacturing is at the center of our commercial value proposition Illustrative assessment of capabilities across the industry (highly simplified) Fed batch Intensified fed batch Continuous Fully continuous and/or some perfusion hybrid capability Paradigm shift in biologics PAGE 20
Slide 21: Advancing towards late stage and commercial programs over time
Advancing towards late stage and commercial programs over time Just - Evotec Biologics supports full development vision for biologics Archetypical development of revenue cascade (non-probability weighted; illustrative) Discovery Early stage Commercial programs clinical supply supply Late stage clini
Slide 22: Rapid growth towards commercial programs together with our partners just started
Rapid growth towards commercial programs together with our partners just started Early discovery and pre-clinical programs build a robust pipeline towards commercial contracts Number of programs 22 Soon 20 to come 2024/2025 18 16 14 12 10 8 6 4 2 0 Discovery Pre-clinical Early clinical Late stage Co
Slide 23: Capacity building up over time
Capacity building up over time Relation between capacity, utilization and revenues FY 2022 FY 2023 FY 2024 FY 2025 300 J.POD® (EU) > € 250 m1 Utilization rate of first two trains reaching 90.0% 90% 250 of add’l Utilization rate75.0% 200 trains reaching 80% 60.0% 150 45.0% 100 30.0% 50 15.0% Revenues
Slide 24: Technology leadership leading to cost advantages
Technology leadership leading to cost advantages Relation between unit costs and revenues FY 2022 FY 2023 FY 2024 FY 2025 300 0.9 250 0.75 200 0.6 150 0.45 100 0.3 50 Cost/gram 0.15 <US$ 50/g Revenues 0 0 -50 -0.15 PAGE 24 CPD = Commercial Process Design
Slide 25: Co-ownership leading to value creation upside
Co-ownership leading to value creation upside High-value partnerships offer path to increased royalties Co-owned biologics pipeline assets1) Business model options Value creation from co-owned projects via ~ 80% milestones & royalties2 ~ 60% >40 2025 expected Revenues Revenues >20 2021 > € 250 m < €
Slide 26: Evotec with strong base business momentum
Evotec with strong base business momentum Leading innovation at balanced risk Accelerating EBITDA growth in first six months €m Group adj. EBITDA excl. Just – Biologics Just – Evotec Biologics Stronger than ever 111.8 base business 103.4 Higher unpartnered R&D spend +8% 54.1 Profitable business even
Slide 27: We are making progress in expanding the partnering pipeline
We are making progress in expanding the partnering pipeline Summary of commercial progress 2022 Just – Evotec Biologics Closed Sales Sales in € m >90 • Closed Sales is leading indicator of future 2023 and 2024 revenues • Closes Sales 2022 show strong growth – indicates market entry progressing and >
Slide 28: A paradigm shift takes persistence and time
A paradigm shift takes persistence and time Case study: Tesla Inc. EBITDA Operational profit Cumulated Capex ROIC US$ m 10,000 40% Paradigm shifts take time 5,000 20% Foundation: 1 July 2003 0 0% > US$ 23 bn capex in last 10 years -5,000 -20% Sustained positive EBITDA as of 2018 -10,000 -40% 2020 fi
Slide 29: Imagine if COGs was < US$ 50 per gram?
Imagine if COGs was < US$ 50 per gram? • Underserved indications and multiple combination treatments • Access to underserved populations and stress reduction for healthcare systems Together for medicines • Access to life saving therapies for underdeveloped regions that matter • Rapid response in glo
Slide 30: Agenda
Agenda 9.00 – 9.30 am Registration 9.30 – 11.00 am Site Tour – Overview and tour preparation 11.00 am Start of webcast 11.00 – 11.30 am Action Plan 2025 11.30 – 12.15 pm Paradigm shift in biologics – From A.I./M.L.-based discovery to agile commercial manufacturing 12.15 – 12.45 pm Lunch Break 12.45
Slide 31: Paradigm shift in biologics
Paradigm shift in biologics From A.I./M.L.-based discovery to agile commercial manufacturing PAGE 31
Slide 32: Experienced leadership team dared to dream
Experienced leadership team dared to dream >500 combined years of expertise Team (current role and experience) Alumni Linda, Zuckerman, Christelle Dagoneau, Randal R. Ketchem, Randal Bass, PhD Sundar Ramanan, Jim Thomas PhD PhD PhD SVP Process Design PhD MBA EVP, Global Head of SVP Global BD Biologi
Slide 33: We are on a journey to provide better access to biologics
We are on a journey to provide better access to biologics Timeline Just HQ J.PLANTTM J.POD® (US) Continuous Network of and lab complete, first client runs: Groundbreaking manufacturing J.PODs® South Lake Union Pandion, Path, BMGF in Redmond demonstrated >7 kg in one run 2014 2015 2016 2017 2018 2019
Slide 34: The paradigm shift is already in motion
The paradigm shift is already in motion Accelerating the paradigm shift in biologics day-by-day Current state Future state Others Stainless steel fed batch Flexible & agile capacity Facility cost >US$ 500 m Facility cost << US$ 500 m Separate upstream & Fully integrated platform downstream processin
Slide 35: Global manufacturing network is "Just at the beginning"
Global manufacturing network is “Just at the beginning” J.POD® – Status and timing Cloning of J.POD® facilities Supply resilience J.PLANT Seattle, J.POD® Toulouse, Facilitate Washington, US France, EU • 500L SUB global access • 500L & 1,000L SUB • Phase I – Clinical • Phase I – Commercial • Over 34
Slide 36: Our technology: Paradigm shift in biologics
Our technology: Paradigm shift in biologics From A.I./M.L.-based discovery to agile commercial manufacturing PAGE 36
Slide 37: We will capture the market by introducing a paradigm shift
We will capture the market by introducing a paradigm shift Integrating critical capabilities to develop medicines that matter and provide access Discover mAbs biased for Design and manufacturability down-select highly manufacturable mAbs Continuous manufacturing for Design processes for highest mass
Slide 38: How we change the biologics value creation paradigm
How we change the biologics value creation paradigm Just – Evotec Biologics value drivers Quality & Agility Cost Risk1 PAGE 38 1 via increasing Probability of Success (PoS)
Slide 39: We change the value creation paradigm for biologics: Quality & Agility
We change the value creation paradigm for biologics Just – Evotec Biologics value drivers as proven in recent projects Quality & Agility Cost Risk 1. No need to scale up from clinical to commercial 2. Ability to build a new J.POD® facility < 24 months 3. Add additional trains/capacity in < 12 months
Slide 40: No need to scale up from clinical to commercial 1/2
1. No need to scale up from clinical to commercial 1/2 Typical scale-up for a commercial mAb vs. Just - Evotec Biologics process 50L 200L 500L 1,000L 20,000L To commercial scale • For US$ 1 bn mAb capability, every 10 meters month lost during Traditional tech transfer is fed batch about US$ 80 m1 •
Slide 41: No need to scale up from clinical to commercial 2/2
1. No need to scale up from clinical to commercial 2/2 Bioreactor duration can be extended with steady-state continuous perfusion technology 500L Early-stage clinical trial 15-day process 5-8 kg drug substance per run 1000L Late-stage clinical trial 25-day process 35-38 kg drug substance per run Com
Slide 42: Ability to build a new J.POD facility < 24 months
2. Ability to build a new J.POD® facility < 24 months Timelines to build a J.POD® or add capacity Time to set up a J.POD® is short Years ~4.0 -63% ~1.5 Traditional J.POD® facility PAGE 42
Slide 43: Add additional trains/capacity in < 12 months
3. Add additional trains/capacity in < 12 months Additional trains in a J.POD® installed quickly Up to 6 per J.POD® Additional trains can be added into an existing facility • Maximum flexibility for build out of facilities Less than 12 months • Limited CAPEX at the beginning • Fully adjustable to cl
Slide 44: Change over time between products < 2 days
4. Change over time between products < 2 days Timeline to change from product A to B Change over in manufacturing is fast ~1-2 weeks >70% reduction ~2 days Two bioreactors in one POD Stainless J.POD® steel process technology PAGE 44
Slide 45: We will capture the market introducing a paradigm shift
We will capture the market introducing a paradigm shift Integrating critical capabilities to develop medicines that matter and provide access • No need to scale up from clinical to commercial • Ability to build a new J.POD® facility < 24 months • Add additional trains/ capacity in <12 months • Chang
Slide 46: We change the value creation paradigm: Risk
We change the value creation paradigm Just – Evotec Biologics value drivers as proven in recent projects Quality & Agility Cost Risk 1. Select the best therapeutic candidate out of >1,000 possibilities via A.I./M.L./Automation 2. Increased automation with less human intervention will reduce the risk
Slide 47: Select the best therapeutic candidate via A.I./M.L./Automation 1/3
1. Select the best therapeutic candidate via A.I./M.L./Automation 1/3 Deep dive on our proprietary tool to reduce attrition early on J.HALSM technology is a GAN application for antibody sequences • Large, human-derived (Real) Training Sequences Real or Synthetic? antibody sequence EVQLQE … VEIKR tra
Slide 48: Select the best therapeutic candidate via A.I./M.L./Automation 2/3
1. Select the best therapeutic candidate via A.I./M.L./Automation 2/3 Deep dive on our proprietary tool to reduce attrition early on GANs control design through transfer learning ∆ CDR H3 Length vs training Set ∆ Immunogenicity vs training Set • Properties are transfer learned to bias for exhibit th
Slide 49: Select the best therapeutic candidate via A.I./M.L./Automation 3/3
1. Select the best therapeutic candidate via A.I./M.L./Automation 3/3 In vitro assay data demonstrating mAbs binding, A.I. driven discovery Agonist: Binding activity Agonist: Functional activity GMFI OD 620-655 HEK + Target Positive control Ab Seq 201 Null NEK cells Isotype control Ab Seq 202 300000
Slide 50: "Lights-out manufacturing" – Less human intervention will reduce risk of failure
2. “Lights-out manufacturing” – Less human intervention will reduce risk of failure Protein A Viral Polishing Capture Viral Inactivation Depth Chromatography Filtration UFDF • Manual operations Traditional Formulation Filtration • Each of the operations fed batch is an individual batch Mix Mix Highl
Slide 51: Higher quality product produced
3. Higher quality product produced Example, heavy chain post-translational modifications are reduced Level of post translational modification Fed batch Just – Evotec Biologics -67% -60% -90% Oxidation Deamidation Glycation PAGE 51 Source: Quantitation by MAM; comparison of the same mAb in both fed b
Slide 52: Lower environmental impact with smaller footprint facility
4. Lower environmental impact with smaller footprint facility Just - Evotec Biologics leads industry in minimizing environmental impact Utilities & HVAC1 • No steam-in-place or clean-in-place utilities needed No Steam-in-place/Clean-in-place = • Water for injection generated by reverse osmosis reduc
Slide 53: We will capture the market introducing a paradigm shift
We will capture the market introducing a paradigm shift Integrating critical capabilities to develop medicines that matter and provide access • Select the best therapeutic candidate out of >1,000 possibilities via A.I./M.L./Automation • Increased automation with less human intervention will reduce t
Slide 54: We change the value creation paradigm for biologics: Cost
We change the value creation paradigm for biologics Just - Evotec Biologics value drivers as proven in recent projects Quality & Agility Cost Risk 1. Selection of best antibody (J.HALSM or J.MDTM) enables highest productivity 2. Highly intensified processing yields lowest possible COGs 3. Ability to
Slide 55: Selection of best antibody enables highest productivity 1/3
1. Selection of best antibody (J.HALSM or J.MDTM) enables highest productivity 1/3 Case study: In silico selection of best two mAbs using J.MD™ High throughput biophysical characterization of mAbs Conformational stability Colloidal stability Thermal DSF DSF1 DSF2 Hold Low pH Zenix 9.5% mAb WSS T1 T2
Slide 56: Selection of best antibody enables highest productivity 2/3
1. Selection of best antibody (J.HALSM or J.MDTM) enables highest productivity 2/3 Sequence optimization reduces pH induced aggregation Low pH aggregation 88.0% High levels of aggregation at low pH would be a potential ~96% stopper in development 40.0% Redesign of ~91% problematic regions increases
Slide 57: Selection of best antibody enables highest productivity 3/3
1. Selection of best antibody (J.HALSM or J.MDTM) enables highest productivity 3/3 Optimization of titer is one of the keys to achieving high productivity at later stages Titers achieved with variant designs, x-fold increase 3.0 Optimized Variants 2.5 2.0 A panel of variant designs compared to the p
Slide 58: Highly intensified processing yields lowest possible COGs 1/4
2. Highly intensified processing yields lowest possible COGs 1/4 Case study: Comparison of fed batch to continuous end-to-end mass output Fully end-to-end continuous process for late-stage products Kg DS 1 per Bioreactor > 25-day production 40 1,000L 35 30 25 20 15 500L 10 5 >7 x 0 Fed Hybrid E2E ba
Slide 59: Highly intensified processing yields lowest possible COGs 2/4
2. Highly intensified processing yields lowest possible COGs 2/4 Comparison of proprietary cell line CL-72 with industry standard Productivity of proprietary Just – Evotec Biologics cell lines vs standard commercial cell lines Permeate Productivity (g/L/d) 4 Just – Evotec Biologics (CL-72) Same DNA
Slide 60: Highly intensified processing yields lowest possible COGs 3/4
2. Highly intensified processing yields lowest possible COGs 3/4 Illustrative example of model compared to manufacturing scale reactor Productivity of proprietary Just – Evotec Biologics cell lines vs traditional cell lines # in 10^6 cells/ml 120 3L Model 110 100 500 L 3L model system 90 Continuous
Slide 61: Highly intensified processing yields lowest possible COGs 4/4
2. Highly intensified processing yields lowest possible COGs 4/4 J.POD® based COGs will facilitate our aspiration for this target COGs < US$ 50/g ~75% Assumptions • 6x1000L facility • 4g/L/day • Traditional CDMO average of US$ 200/g Traditional Just - Evotec CDMOs Biologics PAGE 61
Slide 62: Ability to skip engineering runs for first-in-human programs saves time and costs
3. Ability to skip engineering runs for first-in-human programs saves time and costs Simplified for majority of FIH programs Manufacturing for FIH First-in-human programs (FIH) Phase I ~50% • Scale down models are representative of 500L scale • Thereby reduces need for engineering run(s) Engineering
Slide 63: Substantially lower costs – J.PODs come with a disruptively low capital need
4. Substantially lower costs – J.PODs® come with a disruptively low capital need Comparison between traditional facility and J.POD® Cost of a J.POD® facility US$ m ~ 800 - 1.000 Both suited to produce metric tons -75% ~250 Traditional J.POD® facility PAGE 63
Slide 64: We will capture the market introducing a paradigm shift
We will capture the market introducing a paradigm shift Integrating critical capabilities to develop medicines that matter and provide access • Selection of best antibody (J.HALSM or J.MDTM) enables highest productivity • Highly intensified processing yields lowest possible COGs • Ability to skip en
Slide 65: Let's have lunch together
Let’s have lunch together 30 min lunch break PAGE 65
Slide 66: Agenda
Agenda 9.00 – 9.30 am Registration 9.30 – 11.00 am Site Tour – Overview and tour preparation 11.00 am Start of webcast 11.00 – 11.30 am Action Plan 2025 11.30 – 12.15 pm Paradigm shift in biologics – From A.I./M.L.-based discovery to agile commercial manufacturing 12.15 – 12.45 pm Lunch Break 12.45
Slide 67: Shared vision for biopharmaceutical manufacturing
SHARED VISION FOR BIOPHARMACEUTICAL MANUFACTURING • John C. Erickson, PhD • November 2, 2022 • DISCLAIMER: • Views expressed by authors on the paper represent themselves, not their companies. • Key Opinion Leaders from critical mass of biopharmaceutical manufacturers • Sanofi, BMS, Merck, Pfizer, AZ
Slide 68: Is high COGS a problem? Depends on your point of view
IS HIGH COGS A PROBLEM? DEPENDS ON YOUR POINT OF VIEW Sales – Not often biggest issue • On time, in full delivery, more important • Diminishing returns at high GM • Significant Selling Cost • Do ’t lau h i low argi arkets ✓Corporate—Yes! • Save money in mfg to spend in R&D • Reduce COGS and invento
Slide 69: Discussions about COGS
DISCUSSIONS ABOUT COGS 69
Slide 70: Discussions about CAPEX
DISCUSSIONS ABOUT CAPEX 70
Slide 71: Everyone wants to reduce capital cost of factories
EVERYONE WANTS TO REDUCE CAPITAL COST OF FACTORIES • COGS = CapEx/lifetime+ RM + Labor • COGS = $100/g = $40(dep) + $60 (RM+L) • CapEx can be high even if COGS is low. • Price: $1,000/g, dep = 4% sales Depreciation • CapEx: $500mm • People with $500mm have choices and do ’t like CapEx. Top reasons:
Slide 72: Problem #1: The forecast is usually wrong
PROBLEM #1: THE FORECAST IS USUALLY WRONG 25% • 260 drugs launched 2002-2011 % Consensus Forecasts 20% 15% • … ost …fore asts were 10% wro g, ofte su sta tially 5% • >60% off by > 40% 0% • 20% overly optimistic by >160% • Still wrong years post-launch 0 to 20 > 160 20 to 40 40 to 60 60 to 80 80 to 1
Slide 73: Problem #2: High CAPEX
PROBLEM #2 HIGH CAPEX • Biopharm vs. small molecule • More CapEx • Produce a lot less • 1,000 x more expensive on $/capacity basis • Equipment usually empty or mostly water
Slide 74: Biopharm technology vicious cycle
BIOPHARM TECHNOLOGY VISCIOUS CYCLE Pressure to Resource contract in work Constraints CapEx & guarantee & production 2nd gen Not believing Plant forecast and underutilized delaying capacity when demand expansion or lower than process forecast improvement Expensive long- Not enough term contract to ca
Slide 75: Solution
SOLUTION • Do ’t o plai a out fore asts & R&D pipeli e • Mitigate forecast variability through Flexibility • Lower CapEx to reduce impact of low utilization
Slide 76: Flexibility to make a variety of products in the face of uncertainty and changing demand
FLEXIBILITY TO MAKE A VARIETY OF PRODUCTS IN THE FACE OF UNCERTAINTY AND CHANGING DEMAND • What • Delay capital until just before needed • Problems to solve • More fully utilized facilities/reduced capital • Forecast variability • How: Build o ly what’s eeded ow • Facility fit differences for new •
Slide 77: Capital & operating cost and sustainability not a barrier to availability of capacity
CAPITAL & OPERATING COST AND SUSTAINABILITY NOT A BARRIER TO AVAILABILITY OF CAPACITY, INNOVATION OR CHANGE • What • >100X capital reduction for DS & DP • No need to expand building footprints because process intensifies faster than need to build out. 1. Initial 2. Expand 3. Qualify new 1 1 • COGM l
Slide 78: Vision: By 2029 invent, design, build and help commercialize manufacturing capability
VISION: BY 2029 INVENT, DESIGN, BUILD AND HELP COMMERCIALIZE DRUG SUBSTANCE AND PRODUCT MANUFACTURING CAPABILITY ENABLING: • Flexibility to supply extremely diverse and changing portfolio of products in the face of uncertainty and changing demand • Improved Control, Robustness and Security of Supply
Slide 79: Agenda
Agenda 9.00 – 9.30 am Registration 9.30 – 11.00 am Site Tour – Overview and tour preparation 11.00 am Start of webcast 11.00 – 11.30 am Action Plan 2025 11.30 – 12.15 pm Paradigm shift in biologics – From A.I./M.L.-based discovery to agile commercial manufacturing 12.15 – 12.45 pm Lunch Break 12.45
Slide 80: Markets' needs – Access to medicines that matter
Markets’ needs – Access to medicines that matter PAGE 80
Slide 81: Access to high-quality medicines is today's top-of-mind issue
Access to high-quality medicines is today‘s top-of-mind issue From patient access to building critical biotechnology and biomanufacturing capabilities Selected examples PAGE 81 Source: Press clippings, internet research
Slide 82: Biologics have become foundational therapies
Biologics have become foundational therapies Antibody-based therapies within top-10 drugs in disease by value, number / selected examples Transformed Propelled a Significantly Transformed the treatment paradigm shift in improved care approach towards of AMD Oncology standards in autoimmune Hemophili
Slide 83: Also, biologics will play a major role in the future
Also, biologics will play a major role in the future Number of pipeline products1 in industry R&D pipeline, from Phase I to III 7,000 Antibodies Conjugated & minimized antibodies 6,000 Multi-specific antibodies Biologics Proteins 5,000 Peptides – biological Regenerative Cell therapy medicine 4,000 G
Slide 84: Do these important therapies reach everyone?
Do these important therapies reach everyone? Our contribution to meet UN Sustainable Development Goal 3 7,000 70% 6 bn 12 months underserved higher prices for antibodies without access to first Ab therapy rare indications vs. small molecules in COVID Underserved indications Underserved populations U
Slide 85: What if COGS could be below US$ 50 per gram?
What if COGS could be below US$ 50 per gram? Potential against access opportunity areas Critical factors preventing access Access opportunity areas Cost Agility Risk Serve underserved indications including combination treatments Provide access to underserved populations while providing stress and re
Slide 86: Solving one access challenge at a time: underserved indications
Solving one access challenge at a time: underserved indications Illustration of challenge and solution elements 50% 30 million people of the people affected by 1. High titer cell lines in Europe are living rare diseases are children with rare disease 2. Rapid turn around 2 7,000 30 Product A days mi
Slide 87: Solving one access challenge at a time: underserved populations
Solving one access challenge at a time: underserved populations Illustration of challenge and solution elements Case example for top-5 mAb therapy – Psoriatic Arthritis Comparison of annual treatment costs U.S., in USD (000s)1 US 65 15 Lower COGs potential Italy US$/g UK 13 -77% Top-quartile facilit
Slide 88: With the IRA, a first domino piece fell over with regard to drug pricing
With the IRA, a first domino piece fell over with regard to drug pricing Illustrative scenario for end-of-lifecycle biologics and biosimilars A scenario for pricing impact? Conceptual view on future price levels Before IRA After IRA Biologics Biosimilars (2-3 years before patent loss) PAGE 88 Source
Slide 89: Solving one access challenge at a time: underserved regions
Solving one access challenge at a time: underserved regions Illustration of challenge and solution elements Case study – Countries where key PD-1 antibodies are currently not available Enabling new business models Facility building costs, US$m Traditional ~800 – Facility 1,000 -70- J.POD® - 250 80%
Slide 90: Solving one access challenge at a time: global health & pandemics
Solving one access challenge at a time: global health & pandemics Illustration of challenge and solution elements Preparedness & Rapid Response activities during pandemic phases Prepared- Development to Distribution ness phase II-readiness & treatment Low cost enabling Rapid Accelerated Distribution
Slide 91: Together with our partners for access
TOGETHER with our partners for access Our mission, realized through partnerships Design and apply innovative technologies to dramatically expand global access to biotherapeutics Access to innovative molecules Access to biosimilars Access to pandemic preparedness PAGE 91
Slide 92: We aim to tackle this challenge together
We aim to tackle this challenge TOGETHER Our key partnering archetypes Discovery Development In Market Public • Governments • Foundations • Consortia’s We engage • Public private with a wide partnerships variety of partners to Private provide access • Biotech’s together • Large pharma companies • Bi
Slide 93: We are expanding across disease areas
We are expanding across disease areas Just - Evotec Biologics partnering programs Clinical Commercial No. of J.MDTM Pre-clinical manu- manu- Broad basis for Disease area programs Discovery optimization development facturing facturing sustained growth 1 • > 15 partners / 20 Oncology programs 4 • Cont
Slide 94: Case examples to illustrate our growing impact
Case examples to illustrate our growing impact Recent case examples and ongoing discussions Government Partnership Biotech Partnerships Various partners Biosimilar Partnership Undisclosed partner PAGE 94
Slide 95: Partnership with U.S. Department of Defense (DOD)
Partnership with U.S. Department of Defense (DOD) Discovery to Phase I partnership example to ensure pandemic preparedness 2020 2021 2022 Important catalyst for US$ 18.2 m US$ 28.6 m – Extension Joining DOD’s advanced future acceleration of Selection of anti-SARS- COVID-19 prophylaxis development an
Slide 96: Partnership with Alpine Immune Sciences
Partnership with Alpine Immune Sciences From clinical to commercial partnership for novel biologics June 2020 Q3 2021 August 2022 Demonstration of Just – ALP-3031 Release of Drug Launch of com- Evotec Biologics project kick off Product for PhI/II mercial process platform benefits to clinical study d
Slide 97: We are making progress in expanding the partnering pipeline
We are making progress in expanding the partnering pipeline Summary of commercial progress 2022 Just – Evotec Biologics Key progress Closed Sales since half year results • Closed Sales is leading Sales in € m Secured and initiated indicator of future 2023 >90 and 2024 revenues new anti-Plague mAb de
Slide 98: How we expect to evolve and accelerate the partnering portfolio
How we expect to evolve and accelerate the partnering portfolio Just - Evotec Biologics – Revenues and composition of underlying project portfolio Revenues, US$ m Commercial manufacturing (NBEs & biosimilars) Commercial process development – Late stage clinical manufacturing (NBEs & biosimilars) Bio
Slide 99: We are ready to tackle the global access challenge
We are ready to tackle the global access challenge Just - Evotec Biologics combines unique tools from discovery through manufacturing PAGE 99
Slide 100: Questions and Answers
Slide 101: Volker Braun, SVP Head of Global Investor Relations & ESG
Volker Braun SVP Head of Global Investor Relations & ESG + 49(0)40 560 81 775 (direct) + 49(0)151 1940 5058 (mobile) volker.braun@evotec.com