Arcticzymes Technologies Asa · OSL:AZT
Arcticzymes Technologies Asa — Investor Presentation (February 2023)
38 slides from Arcticzymes Technologies Asa's investor presentation, February 2023
Slide 1: Research & Development
Research & Development Darren Ellis February 2023
Slide 2: Agenda: R&D
1 ArcticZymes 2 Customers 3 Product Development 4 Product Placement 5 Innovation Cycle 6 Summary
Slide 3: ArcticZymes is well-named
ArcticZymes is well-named Cold-adaptation Cold-active Enzyme properties Heat-sensitive Salt tolerant The Arctic ecosystem is a vast genetic resource Unique
Slide 4: ArcticZymes operates B2B
ArcticZymes operates B2B Primary markets – Biomanufacturing and Molecular Tools (Dx) “Biomanufacturing” Customer Pharma Hospitals ArcticZymes over 300 Business-to-Business (B2B) customers Service Labs Technologies Researchers component provider End-users 100,000s scientists, Customer doctors, clinic
Slide 5: Primary B2B markets – customer groups
Primary B2B markets – customer groups Product Family Alignment Molecular Tools (Molecular Diagnostics & Research) Biomanufacturing (Therapeutics) RNA IsoPol™ SAN (Salt Active Polymerases Shrimp Alkaline Cod Uracil DNA Ligase Proteinase M-SAN HQ Polymerase Nuclease) HQ family Phosphatase Glycosylase
Slide 6: R&D Team
R&D Team Organization 24 staff – 13 PhD’s, international Functional Discovery Development Post Launch Areas Bioinformatics & Rec. expression Technical Sequence in E. Coli & Support Mapping P. pastoris Structure analysis Process Functional Assay Core & in-silico development Dev & Data Competencies en
Slide 7: How we develop products – ISO13485
How we develop products – ISO13485 Phases, Goals, Risks, Timelines 2 years 12-24 months years Strategy return on investment VOC / Lifecycle planning & strategy de-risked prototype product launch Customer risk profile maximise (VOC) Product Lifecycle Academia (in-licencing) Discovery Product Developm
Slide 8: Combined B2B product development – pipeline
Combined B2B product development – pipeline Time-to-market $ Sales $ Sales Regulatory Approval ISO13485 ISO13485 / cGMP On-market product ArcticZymes’ Customer’s Prod Dev Idea Hospital Product Dev (Dx / Therapeutics) Service Lab AZT new product 2-4 yr (multistep) 2 – 6 years (multistep) ~decades Pip
Slide 9: Product Placement – Molecular Dx
Product Placement – Molecular Dx Case Study - Viral Dx qPCR workflow <PCR <PCR <SP robot> instrument> set-up> Sample Sample Sample Prep Assay Read Out Collection PrePrep Reverse Taq Transcriptase Polymerase (new) IsoPol™ Nuclease Proteinase Cod UNG RT-PCR Polymerases Applications Link individual enz
Slide 10: Molecular Diagnostics
Molecular Diagnostics Building product value Building product value through • Complete MDx workflow with essential enzymes Reverse Transcriptase and Taq DNA Polymerase Showing performance of Reverse Transcriptase RNA Virus isolated from serum • Customer-facing Application Data • Link individual AZT
Slide 11: Product Placement - Biomanufacturing
Product Placement - Biomanufacturing Case Study – viral vector manufacturing (CGT) SAN HQ SAN HQ high salt matrix Nuclease ? ✓ ELISA high viscosity digestion viral vector manufacturing workflow (multi-step) Remove unwanted nucleic acids Reduce viscosity impure viral vector SAN HQ pure removal vi
Slide 12: Innovation Cycle
Innovation Cycle How VOC and Product Dev work together Product Development Development Discovery Manufacturing ISO13485 Customer Hospital ArcticZymes Service Lab (Dx / Therapeutics) ISO13485 Discovery cGMP Manufacturing Market Trends Technical Development Regulatory Commercial Testing & Validation V
Slide 13: Innovation Cycle: Evolution of the SAN product family
Innovation Cycle Case Study – Evolution of the salt-active nuclease (SAN) product family 2021 SAN 2022 M-SAN HQ 2.0 ELISA ELISA 2019 M- 2021 SAN SAN HQ HQ 2.0 Bioprocessing 2011 2017 2023 SAN D HL- SAN HQ SAN “GMP M SAN HQ grade” F Research 2015 SAN HQ ELISA 2017 ELISA
Slide 14: Building out the product portfolio: Q4 2022
Building out the product portfolio Retrospective Q4 2022 – new products ✓ ArcticZymes Proteinase Glycerol Free ❑ - Very significant scale-up, lyophilization-friendly (and Scale up ArcticZymes Proteinase) - Critical enzyme for MDx, converts information from ✓ AZScript (Reverse Transcriptase) ❑ RNA to
Slide 15: Building out the product portfolio: new products 2023
Building out the product portfolio Looking to the near future – new products 2023 * ❑ ArcticZymes Proteinase “bioprocessing - Building another pillar to our bioprocessing range grade” ❑ Taq Polymerase - Essential, the heart of molecular biology and MDx ❑ Salt Activated Nuclease - SAN “GMP grade” - P
Slide 16: Building out the product portfolio: beyond 2023
Building out the product portfolio Looking further ahead – beyond 2023 * ❑ Expand Biomanufacturing capabilities o SAN product lifecycle management o Value through Quality – Transitions & DMF o RNA therapeutics – generic & novel o Two pillars – nucleases and proteinases ❑ Expand Molecular Tools capab
Slide 17: Summary
Summary Drive Innovation Expand the Portfolio Support the Products Leverage Discovery Novel unique products Applications Understand the Market Fill in the workflow gaps Technical relationships VOC-Product Lifecycle Value through Quality Work with customers 17
Slide 18: Operations
Operations Marit Sjo Lorentzen February 2023
Slide 19: Operations agenda
Operations 1 Organisation 2 Facilities, Equipment and Capacity 3 Scalability and Future Growth 4 Logistics 5 Audits 6 Summary
Slide 20: Organisation
Organisation Personnel (15) Fermentation and Purification: 7. Filling and Shipments: 2 Process Development: 2 – 3. Quality Control: 4. Recruitment Mainly University and University Hospital in Tromsø Competence Highly competent personnel Continous internal competence building QC department transfer t
Slide 21: Facilities
Facilities Fermentation, Purification and Process Development 21
Slide 22: Equipment and capacity: Fermentation and purification
Equipment and capacity Fermentation and purification Parallel lines Recombinant production in E. coli and P. pastoris. Yield: kUnits – MUnits – BUnits (depending on product). Fermentors. Internal and external (Contract Development Manufacturing Organisations). Purification systems. Equipment dedicat
Slide 23: Equipment and capacity: QC and Filling
Equipment and capacity QC and Filling Quality Control Separated from fermentation and purification. Shared equipment with R&D. Filling (always in Tromsø) Manual. Automated. 23
Slide 24: Scalability
Scalability Fermentation Up to 30 L in SIVA Innovation Centre (according to the Health Directorate). All products are scalable. rSAP and HL-SAN/SAN HQ/SAN HQ 2.0/M-SAN HQ at fermentation contractors (1 500 or 750 L). Paras Biopharmaceuticals for SAN HQ. Premises built for cGMP production. Aiming at
Slide 25: Future growth (fermentation)
Future growth (fermentation) External CDMO’s Pros: No infrastructure or equipment investments. Cons: Risk of compromising products (agreements in place). Lack of complete control (cGMP requirements). Build own facilities Pros: Complete control of premises, equipment and products. Cons: Lack of compe
Slide 26: Logistics
Logistics Standard order Custom order Standard products shipped from AZ’s warehouses. Customised products and/or customised delivery methods. Cryo Store in Joure, Netherlands, for EU and Asia. Percorso in Philadelphia, USA for US and Japan. Normally from AZ’s head quarter. Tromsø, primarily for Norw
Slide 27: Audits
Audits ISO 13485 Recertification every 3rd year (last in 2021). Surveillance (December 2022). No critical deviations. Customer audits (mainly for Bioprocessing) Ten audits last two years ISO 13485 and relevant cGMP guidelines. Results No critical deviations. Continous cGMP competence. Continous impr
Slide 28: Summary
Summary Capacity Scalability Future growth Facility All products Internally Equipment CDMO’s Personnel Buy? 28
Slide 29: Commercial
Commercial Dirk Hahneiser February 2023
Slide 30: Commercial agenda
1 Team 2 Sales Cycle 3 Areas for improvement in 2023 4 Sales by Geography 2022 5 Market Potential 6 Drug Master File (DMF) 7 Marketing & Sales Activities 8 Summary
Slide 31: Commercial Team
Commercial Team Business Development France, Germany, Northern & Eastern Switzerland, Austria, Iberia, Europe, Middle East and Technical Sales North America (2) Japan Italy, Turkey, Africa, Central Asia Pacific except Japan Specialist & South America & China Marketing & Customer Service Marketing Ma
Slide 32: The Sales Process & Cycle
The Sales Process & Cycle PIPELINE MANAGEMENT OPPORTUNITY MANAGEMENT Win Rate Continuously feeding the pipeline Deal Value Working with numerous customers in various stages of the sales cycle Rigorous Sales Management Process DMF & Application Data help accelerate Length of Sales Cycle cycle Number
Slide 33: Key areas to improve in 2023
Key areas to improve in 2023 Commercial Excellence Demand Generation Collaboration • Execute price increase of 8.5% from • Laser sharp focus on generating • Closer collaboration between January 1, 2023 new business with Key Accounts Market Development Managers • Execute Shipping & Handling fee • Agg
Slide 34: 2022 Sales by Geography
2022 Sales by Geography Even split between North America and Europe, Asia needs more attention North America 45% Europe 44% Asia 11% 34
Slide 35: Market Potential
Market Potential Our partners who profit from our expertise Biomanufacturing Focus on Cell & Gene Therapies Market Size 2022 – 2030 Diagnostic Companies 13.85 - 75.6 Bil USD (CAGR 23.6% 2022-2030) Enzymes for driving assay technologies. Bio-manufacturers Manufacturers of viruses for gene therapy and
Slide 36: Marketing & Sales Investments & Activities
Marketing & Sales Investments & Activities To support lead and demand generation Digital Marketing Trade Shows Transform web presence Participate at selected, from informational to most important trade interactive and lead shows to increase generation tool awareness and leads Improved Analytics Sale
Slide 37: Drug Master File
Drug Master File What is it? A drug master file (DMF) is a submission to the FDA that contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. It is used to provide information to th
Slide 38: Summary
Summary Leverage Prioritize Accelerate Market Potential Demand Generation Sales Cycle • Grow with and take • Winning with Key Accounts • Continue to build share in Molecular Tools • Get in early with highly opportunity pipeline & Biomanufacturing innovative incubators • Improve probability and • Tap
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