Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — FY2020 Earnings Presentation
37 slides from Nanoform Finland Oyj's earnings presentation, Feb 26, 2021
Slide 1: Nanoform Management Presentation
Nanoform Management Presentation February 26th, 2021 Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform’s platform technologies. T
Slide 2: Disclaimer
Disclaimer Forward-Looking Statements This presentation may contain forward-looking statements, including, without limitation, statements regarding Nanoform’s strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,”
Slide 3: Introduction to Nanoform
Introduction to Nanoform
Slide 4: Nanoform in a Snapshot
Nanoform in a Snapshot Nanoform Platform Technology Bulk The Share API ➢ Global experts in nanotechnology and drug particle engineering ➢ CESS® technology for small ➢ Listed June 4th, 2020 on molecules (chemical Nasdaq First North Premier compounds) discovered in Growth Market in Helsinki 2012 ➢ Abo
Slide 5: Global pharma market projected to reach USD 1.5tn by 2023
Global pharma market projected to reach USD 1.5tn by 2023 Global medicine spending 2010-2023E (USDtn) Global prescription drug sales from top 100 products (USDbn) 1.6 ~1.5 400 357 1.4 ~1.3 350 ~1.2 306 1.2 ~1.1 300 262 1.0 ~0.9 250 0.8 200 0.6 150 0.4 100 0.2 50 0.0 0 2010 2018 2024E ➢ Significant m
Slide 6: The structural pharma R&D problem
The structural pharma R&D problem Less than 50 drugs approved in the US annually on average… …while the global pharma industry R&D expenditure exceeds $180B Annual number of novel drug approvals by FDA 2010-2020 Global pharmaceutical R&D spending 2010-2024E (USDbn) Chemical Biologics 60 250 213 50 1
Slide 7: Low bioavailability is the key issue
Low bioavailability is the key issue Poor bioavailability and low efficacy most common reasons for drug failure Majority of new drugs suffer from poor solubility Solubility Reasons for drug failure in pre-clinical trials (share of molecules) High Low 45% 40% 35% Class I1 Class II1 On market: 35% On
Slide 8: Nanoform is here to fill the gap
Nanoform is here to fill the gap The solution to low bioavailability is to decrease the particle size of the Active Pharmaceutical Ingredient (API)… Giving unsuccessful Enabling new drug candidates drugs a second chance Improving (reduce attrition) existing drugs …and Nanoform’s CESS® is the only te
Slide 9: Particle size is key
Particle size is key Smaller particle size improves a drug’s bioavailability Pre-nanoformation Post-nanoformation ➢ Smaller particles have a larger surface area ➢ Larger surface area of particles enables better bioavailability of a drug ➢ Improved bioavailability implies better absorption of a drug
Slide 10: Potential benefits of CESS commercialization
Source: Company information - Potential benefits assuming that CESS® is successfully commercialized and adopted by the pharma industry 10
Slide 11: CESS Superior to Existing Technologies
CESS® Superior to Existing Technologies1 CESS® comparison with existing technologies Controlled Expansion of Rapid Expansion of Solid dispersion Supercritical Solutions Supercritical Solutions Jet milling Nanomilling (e.g. spray drying) (CESS®) (RESS) Extracts API from supercritical Extracts API fro
Slide 12: Johnson Matthey study - benchmarking CESS technology
JOHNSON MATTHEY PLC (FTSE100) STUDY - BENCHMARKING CESS® TECHNOLOGY New data % Release over Time Right side top down: 100 Nanoformed Spray dried 90 Micronized Succinic acid co-crystal ➢ In-vitro dissolution study on 80 Milled Ethanolamine salt Piroxicam conducted by JM’s 70 HME Pharmorphix® CDMO Org
Slide 13: A potential game-changer in Biologics
A potential game-changer in Biologics ➢ Proprietary nanoparticle formation technology to deliver biological nanoparticles as small as 50 nm. ➢ Technology is in early stages of development and a patent application was recently filed with the US Patent Office. Pre-clinical data on multiple biological
Slide 14: Lots of synergies between the technology platforms
Lots of synergies between the technology platforms Small Molecules/Chemical API’s Large Molecules/Biological API’s Comments Attractive market ✓ ✓ Interlinked and roughly equally large markets. ✓ ✓ Faster and clearer early path with lots of Platform technology Patented, proprietary tech Patent applic
Slide 15: Simplified value chain
Simplified value chain High level overview of Nanoform’s value chain and business model Nanoform does not carry the costs of drug development (including customers’ clinical trials) Bulk API Launch of new drugs, improving existing drugs & reducing clinical attrition Clients Revenue Nanoformed ➢ Globa
Slide 16: Revenue drivers and industry attrition rates
Revenue drivers and industry attrition rates Nanoform pre-clinical and clinical revenue drivers Global Pharmaceutical industry’s pre-clinical and clinical success rates NME Biologic Non-NME 1) Non-GMP GMP 100% 90% 88% > Attrition between previous 90% and current phase 78% 80% > Price per phase per A
Slide 17: Nanoform - Attractive revenue model
Nanoform - Attractive revenue model Predictable revenue streams through capitalizing the entire pharmaceuticals value chain Phase Proof of Concept / Proof of Process Phase I – III trials Drugs on the market Certification Non-GMP GMP GMP ➢ Proof of concept study - assessment of the ➢ API for clinical
Slide 18: Year-end report 2020
Year-end report 2020
Slide 19: Nanoform 2020 Key Milestones
Nanoform 2020 Key Milestones Manufacturing Personnel ✓ GMP certification and first GMP line commissioned ✓ Miguel Calado appointed as Chairman of the Board ✓ Number of non-GMP production lines doubled from 4 to 8 during year ✓ Cynthia Schwalm elected as board member ✓ First ever nanoformed API mater
Slide 20: Significant events after 1-12/2020 reporting period
Significant events after 1-12/2020 reporting period Jan Nanoform included in Nasdaq First North 25 index as of Jan 4th, 2021 Jan Nanoform sets a new near-term business target for 2021: “At least 12 new non-GMP customer projects and at least one new GMP customer project in 2021” Jan Nanoform’s clinic
Slide 21: First ever ongoing human trial of a nanoformed drug using CESS
First ever ongoing human trial of a nanoformed drug using CESS® - in partnership with Quotient Sciences (CRO) Process Targets First Interim Results ➢ Nanoform has manufactured the ➢ In the clinical trial Nanoform ➢ Clinical study indicates positive nanoformed piroxicam API in Helsinki investigates t
Slide 22: Additional Positive Interim Results from Nanoform's Clinical Study
Additional Positive Interim Results from Nanoform’s Clinical Study Press released Feb 24th, 2021 First set of interim human data (released January 22, 2021) showed faster absorption of Nanoform’s CESS® nanoformed formulation against Felden®, the reference product, marketed by Pfizer. In the second p
Slide 23: Nanoform Q4 & FY2020 KPI's
Nanoform Q4 & FY2020 KPI’s Financial KPI’s Operational KPI’s EUR thousand 10-12/2020 10-12/2019 1-12/2020 1-12/2019 10-12/2020 10-12/2019 1-12/2020 1-12/2019 Revenue 186 49 687 49 Number of new customer projects started during the period Gross profit 135 -141 497 -323 Non-GMP 3 2 10 2 EBITDA -4,223
Slide 24: Nanoform Q4 & FY2020 Income Statement
Nanoform Q4 & FY2020 Income Statement Consolidated statement of comprehensive income 1-12/2020 comments EUR thousand 10-12/2020 10-12/2019 1-12/2020 1-12/2019 ➢ In 2020 revenue stemmed from twelve different PoC projects for clients (two projects created revenue in 2019). 10 new projects were started
Slide 25: Nanoform near-term business targets
Nanoform near-term business targets Topic Target Status Achieved - GMP certificate GMP Approval “GMP approval expected no later than Q3 2020” awarded April 2020 ✓ “For 2020, our ambition is to accelerate our growth Achieved – 4 new customers Ongoing Client Intake by winning more new customers than i
Slide 26: Small molecules: Non-GMP capacity and PoC projects
Small molecules: Non-GMP capacity and PoC projects Number of non-GMP manufacturing Number of non-GMP manufacturing "at least 50 lines (cumulative) lines by year end new API's" Number of new Proof of Concept New Proof of Concept (PoC) (PoC) customer API projects started 50 customer API projects annua
Slide 27: Nanoform mid-term business targets 2025
Nanoform mid-term business targets 2025 25 lines of >50 which Cash new APIs 5-10 are flow per year GMP positive compliant >90% ~200 gross employees margin API = Active Pharmaceutical Ingredient 27 GMP = Good Manufacturing Practice
Slide 28: A Selection of Nanoform Institutional Shareholders
A Selection of Nanoform Institutional Shareholders1 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ 28
Slide 29: Q&A
Q&A
Slide 30: Appendix
Appendix
Slide 31: International team of highly skilled professionals
International team of highly skilled professionals International & multidisciplinary team of experts… …with currently largest representation in R&D function Personnel split by main functions Currently ~85 R&D employees and 15 5% GMP Manufacturing nationalities 5% growing based in 7% 27% Admin 6 coun
Slide 32: Sales & marketing team
Sales & marketing team The commercial team has brought in their industry contacts and expertise to perfect the commercial positioning Commercial to the Pharma Associate industry BD Britta Sergie Madison Letser UK based marketing communication agency supports Nanoform on a continuous basis CCO Christ
Slide 33: Management team: Multi-disciplinary with international merits
Management team: Multi-disciplinary with international merits CEO & Co-founder; Ph.D. (applied Physics), MBA CFO and member of the Board; B.Sc. (Econ.) Edward Hæggström Albert Hæggström • Professor at the University of Helsinki, Head of Electronics Research Lab. • Over 20 years of experience from fi
Slide 34: Board of directors: Top executives from leading industry positions
Board of directors: Top executives from leading industry positions Miguel Calado Cynthia Schwalm Chairman of the Board Board Member • Previously CFO at international particle engineering CDMO • Over 30 years in executive positions for top-tier global company Hovione Group pharmaceutical organisation
Slide 35: Nanoform Pharma & Biotech Clients Feb/2021
Nanoform Pharma & Biotech Clients Feb/2021 Client announced 2019 Nanoform targets to achieve scale in APIs Client announced 2020 1 Global large pharma Tier 2 – Mid-sized and specialty Client announced 2021 pharma and biotech ✓ Financially stable organizations ✓ Broad pipeline of APIs in development
Slide 36: Current R&D and manufacturing footprint
Current R&D and manufacturing footprint One Nanoform’s nanoforming headquarters, R&D line takes very little room and manufacturing is located at Cultivator I & II buildings in one of Finland’s largest bioscience hubs in Helsinki. Nanoform Nanoform is HQ & manufacturing site in Helsinki Several non-G
Slide 37: Further enquiries
Further enquiries: CFO Albert Hæggström albert.haeggstrom@nanoform.com +358 29 370 0150 Director of Investor Relations Henri von Haartman hvh@nanoform.com +46 7686 650 11 Financial calendar: April 6, 2021 - Annual General Meeting, Helsinki May 27, 2021 - Interim Report for January-March 2021