Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — FY2023 Earnings Presentation
56 slides from Nanoform Finland Oyj's earnings presentation, Feb 29, 2024
Slide 1: Nanoform Management Presentation Q4 & FY 2023
Nanoform Management Presentation Q4 & FY 2023 February 29th, 2024
Slide 2: Disclaimer
Disclaimer Forward-Looking Statements This presentation contains 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,” “est
Slide 3: Table of contents
Table of contents 1. Short introduction to Nanoform 2. 2023 highlights 3. Financials 4. Nanoforming vs ASDs (Amorphous Solid Dispersions) ✓ Project Nanoenzalutamide ✓ Project Nanoapalutamide ✓ Business Finland grant 5. Commercial 6. Q&A 3 Nanoform.com | @nanoform
Slide 4: Short introduction to Nanoform
SHORT Nanoform Breaker INTRODUCTION TO Slide Option 2 NANOFORM CEO Edward Hæggström 4 Nanoform.com | @nanoform
Slide 5: The structural pharma R&D problem
The structural pharma R&D problem Fever than 50 drugs approved in the US annually on average… …while the global pharma industry R&D expenditure exceeds $200B Annual number of novel drug approvals by FDA 2010-2023 Global pharmaceutical R&D spending 2014-2028E (USDbn) Chemical Biologics 300 60 278 285
Slide 6: Nanoform in a snapshot
Nanoform in a snapshot TECHNOLOGY PEOPLE MEDICINES FINANCE PATIENTS Q1 2024 Global experts in 165 employees, Staff with Strong balance Improving lives of nanotechnology 38 nationalities, combined sheet & patients through & drug particle 38 PhD’s in US, experience of institutional game-changing engin
Slide 7: Proprietary technology platforms
Proprietary technology platforms Small Large Formulation AI molecules molecules CESS®* technology Our unique biologic Full therapeutic STARMAP® online is enables new medicines nanoparticles enable potential is unlocked the digital twin of our through improved improved with nano-formulated CESS® proc
Slide 8: 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 9: Particle size is key
Particle size is key Smaller particle size can improve a drug’s bioavailability Pre-nanoforming Post-nanoforming • Smaller particles have a larger surface area • Larger surface area of particles enables improved bioavailability of a drug • The surface area increases 30 fold from a 10 micron1 sized p
Slide 10: Small molecules - Small is powerful
Small molecules - Small is powerful® 10 Nanoform.com | @nanoform
Slide 11: 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 Enabling Improving unsuccessful new drugs existing drug candidates a drugs second chance > 20,000 drugs in > 5,800 > 58,000 failed development* e
Slide 12: Simplified value chain
Simplified value chain High level overview of Nanoform’s value chain and business model Bulk API Launch of new drugs, improving existing drugs & reducing clinical attrition Clients Revenue ➢ Global large pharma Nanoformed ➢ Fixed fee per project API ➢ Royalty as a % based on ➢ Mid-sized and specialt
Slide 13: 2023 Highlights
Nanoform2023 Breaker Slide Option 2 HIGHLIGHTS CEO Edward Hæggström 13 Nanoform.com | @nanoform
Slide 14: Nanoform 2023 Highlights
Nanoform 2023 Highlights ✓ Project Nanoenzalutamide progressing well with a powerful set of very promising clinical data ✓ New promising data on project Nanoapalutamide (PR Feb 29th, 2024) ✓ Strong business opportunity within Amorphous Solid Dispersions (ASDs) ✓ Record number (22+1) of new projects
Slide 15: Financials
Nanoform Breaker Slide FINANCIALS Option 2 CFO Albert Hæggström 15 Nanoform.com | @nanoform
Slide 16: Nr of employees & nr of lines
Nr of employees & nr of lines GMP lines 2&3 will be commissioned after inspection by Fimea, expected during 1H24 16
Slide 17: Nr of projects signed and nr of projects generating revenue
Nr of projects signed and nr of projects generating revenue 17
Slide 18: Nr of projects generating revenue
Nr of projects generating revenue 18
Slide 19: Nr of projects signed
Nr of projects signed 25 20 15 10 4Q20 4Q21 Nr of non-GMP projects signed 10 4Q22. 4023 2020 16 2021 17 2022 22 2023 75 50 25 Nr of projects, annually & cumulatively 16 7 10 2019 2020. «2021: «= 2022-2023 Nr of non-GMP projects signed 67 wa 45 28 2 =>2020 =>2021 =>2022 =>2023 Nr of GMP projects
Slide 20: Revenue recognized impacted by slow signings in 2H22
* Revenue recognized impacted by slow signings in 2H22 *Impact on revenue can in a quarter(s) for some of the projects be negative if budgeted costs increase significantly. 20
Slide 21: Project Nanoenzalutamide has led to increased external GMP QC cost
Project Nanoenzalutamide has led to increased external GMP QC cost Excluding the cost of external GMP QC services, related to Project Nanoenzalutamide, our underlying gross margin has remained above 90%. In June 2023, Nanoform submitted a notification to the Finnish Medicines Agency to update our Ma
Slide 22: Improvement in cash flow continued throughout the year
Improvement in cash flow continued throughout the year Nanoform had EUR 47.5m in cash & short-term government bonds and no debt at the end of 2023. 22
Slide 23: Nanoforming vs ASDs
NANOFORMING Nanoform Breaker Slide VS Option 2 ASDs Peter Hänninen 23 ASDs = Amorphous Solid Dispersions Nanoform.com | @nanoform
Slide 24: Business case Amorphous Solid Dispersions (ASDs)
Business case Amorphous Solid Dispersions (ASDs) Amorphous solid dispersion (ASD) medicines are currently the leading formulation strategy for poorly soluble APIs and there are ~50 marketed medicines globally that are ASDs and sell for ~$50bln annually Nanoformed and nanocrystalline medicines (e.g.
Slide 25: STARMAP predicts nanoforming is an attractive alternative to ASDs
STARMAP® predicts that nanoforming is an attractive alternative to ASDs Amorphous solid dispersions (n=46 APIs) ✓ STARMAP predicts that 78% of marketed ASD APIs fall 5 within our processing “sweet spot" Propensity to crystallise in CESS ✓ 46 ASDs have been Starmapped 4 ✓ There are ~50 ASDs on the ma
Slide 26: Project Nanoenzalutamide
PROJECT Nanoform Breaker Slide NANOENZALUTAMIDE Option 2 VP Strategic Insights Jamie Unwin 26 Nanoform.com | @nanoform
Slide 27: Project Nanoenzalutamide – a potential breakthrough
Project Nanoenzalutamide – a potential breakthrough Q1 2024 Existing blockbuster drug Nanoformed drug Xtandi®* Nanoenzalutamide • Development & commercialization of a • Xtandi® - #1 prescribed androgen more patient-centric drug receptor inhibitor, approved by FDA (2012) to treat prostate cancer • Na
Slide 28: Very promising clinical results for nanotechnology-enhanced Enzalutamide
Important milestone with very promising clinical results for patient- centric nanotechnology-enhanced Enzalutamide – Jan 26th, 2024 Clinical trial: Very promising relative bioavailability study of nanocrystalline-enabled enzalutamide (nanoenzalutamide) tablet formulation Nanoforming benefits: ▪ Oppo
Slide 29: Multiple routes to create value
Multiple routes to create value Global value-add Specialist value-added Originator medicine companies medicine companies Global Global/Continent/Region Region/Country 29 Nanoform.com | @nanoform
Slide 30: Project Nanoapalutamide
Nanoform Breaker Slide PROJECT Option 2 NANOAPALUTAMIDE VP Strategic Insights Jamie Unwin 30 Nanoform.com | @nanoform
Slide 31: Promising results for Project Nanoapalutamide
Promising results for Project Nanoapalutamide 31 Latest press releases: Press releases – Nanoform small is powerful Nanoform.com | @nanoform
Slide 32: Business Finland Grant
Nanoform Breaker Slide BusinessOption Finland2Grant Peter Hänninen 32 Nanoform.com | @nanoform
Slide 33: Business Finland Grant
Business Finland Grant ➢ EUR 4.3M Grant ➢ Business Finland - the Finnish government organization for innovation funding and trade ➢ For the development of nanoparticle-enabled formulation platforms for next generation medicines within the following drug delivery technology areas: ▪ Oral* (the green
Slide 34: Commercial
Nanoform Breaker Slide Commercial Option 2 CCO Christian Jones 34 Nanoform.com | @nanoform
Slide 35: Cumulative nr of customer projects signed
Cumulative nr of customer projects signed 71 48 30 12 2 2019 2020 2021 2022 2023 35
Slide 36: Cumulative nr of customers signed
Cumulative nr of customers signed 41 32 20 7 2 2019 2020 2021 2022 2023 36
Slide 37: Commercial Relationships 2019-2023
Commercial Relationships 2019-2023 10 major pharma (50% of top-20) 27 mid-sized, specialty pharma & 1 co-development biotech companies 3 collaborations 37 Nanoform.com | @nanoform
Slide 38: Selection of Nanoform Pharmaceutical Partnerships
Selection of Nanoform Pharmaceutical Partnerships - 10 of the top 20 Major Pharma and many Biotechs including 38 Nanoform.com | @nanoform
Slide 39: Nanoform customer projects – therapy area overview
Nanoform customer projects – therapy area overview* Pre-Clinical Phase I Phase II & III Marketed/505b2 Cardiology Immunology/Inflammation Metabolism and Endocrinology Infectious Disease (e.g. Anemia) (e.g. Cystic Fibrosis) (e.g. Adrenal Hyperplasia) (e.g. HIV) Gastroenterology Dermatology/Oncology N
Slide 40: Areas where STARMAP sees strong potential for nanoforming
Examples of areas in which STARMAP® sees strong potential for nanoforming Neurodegenerative disorders (n=38 APIs)1 Prostate Cancer (n=11)3 HIV (n=24)2 5 5 5 Propensity to crystallise in CESS Propensity to crystallise in CESS Propensity to crystallise in CESS 4 4 4 3 71% 3 82% 3 83% 2 2 2 1 1 1 1 2 3
Slide 41: Q & A
Nanoform Breaker Slide Q & A2 Option www.nanoform.com San Diego - New York - Lisbon - Oxford – London - Cambridge - Bordeaux - Stockholm - Helsinki 41 Nanoform.com | @nanoform
Slide 42: Appendix
APPENDIX 42 Nanoform.com | @nanoform
Slide 43: Financial KPI's
Financial KPI's Financial KPI's Operational KPI's 1-12/2021 1-12/2020 10-12/2023 10-12/2022 1-12/2023 _1-12/2022 _1-12/2021_1-12/2020 10-12/2023 10-12/2022 1-12/2023 1-12/2022 EUR thousand Mt ‘Total number of new customer projects Total number of lines (end of period) 20 13 20 19 8 A 49 nanoform nan
Slide 44: Income statement
Income statement 1-12/2023 comments ➢Revenue came in at EUR 2.6 million, stemming from 33 different customer projects (EUR 3.5m, 35 projects in 2022). ➢The gross profit decreased to EUR 1.7 million, with a gross margin of 67% (EUR 3.1 million, 90%) due to GMP QC costs related to the nanoenzalutamide
Slide 45: Project Glioblastoma
Project Glioblastoma Nanoform customer TargTex S.A. was granted Orphan Drug Designation by FDA for its nanoformed drug candidate TTX101 to be used in patients with malignant gliomas The hydrogel nanoformulation developed by Nanoform enabled a 200-fold increase in drug load compared to bulk and a 5-f
Slide 46: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders 46 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ Nanoform.com | @nanoform
Slide 47: Revenue drivers & industry attrition rates
Revenue drivers & industry attrition rates Nanoform pre-clinical and clinical revenue drivers Global Pharmaceutical industry’s pre-clinical and clinical success rates Non-GMP GMP ➢ Attrition between previous and current phase ➢ Price per phase per API ➢ # of active customers Phase I, ➢ Time lag betw
Slide 48: Small Molecules - Proprietary technology
Small Molecules - Proprietary technology Green technology Controlled Expansion of Supercritical Solutions - CESS® Contro lled ➢ Relatively simple process developed through combining deep knowledge in physics, chemistry, and pharma 48 The CESS® technology platform was described in detail in the IPO p
Slide 49: Large molecules - Proprietary technology
Large molecules - Proprietary technology Green technology Nanoforming process for biologics API = active pharmaceutical ingredient 49 Nebulization = turns liquid into mist Nanoform.com | @nanoform Ionization = particles electrically charged
Slide 50: CESS Superior to Existing Technologies
CESS® Superior to Existing Technologies Controlled Expansion of Solid dispersion Supercritical Solutions Jet milling Nanomilling (e.g. spray drying) (CESS®) Extracts API from API is dispersed into a solid Application of energy to supercritical CO2 by applying material, which dissolves API particle s
Slide 51: Attractive revenue model, stands the test of time
Nanoform – Attractive revenue model, stands the test of time 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
Slide 52: Nanoform near-term business targets 2024
Nanoform near-term business targets 2024 Topic Target Status Bulk Increased number of non-GMP API and GMP Customer Projects New target projects signed in 2024 vs 2023 * Improved operating Operating free cashflow New Target Free Cashflow in 2024 vs 2023 ** Nanoformed API To sign one or several licens
Slide 53: Nanoform mid-term business targets 2025
Nanoform mid-term business targets 2025 >70 35 lines of which 200-250 new APIs per 7-14 are employees year GMP compliant >90% Cash flow gross margin positive 53 Nanoform.com | @nanoform
Slide 54: 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. (Economics) Edward Hæggström • Professor at the University of Helsinki, Head of Electronics Research Lab. Albert Hæggström • 20 years of finance and investi
Slide 55: Board of directors: Top executives from leading industry positions
Board of directors: Top executives from leading industry positions Miguel Calado Albert Hæggström Chairman of the Board CFO and Board Member • Previously CFO at international particle engineering CDMO • 20 years of finance and investing experience company Hovione Group • Prior roles include position
Slide 56: Thank you
Thank you FURTHER ENQUIRIES CFO Albert Hæggström, albert.haeggstrom@nanoform.com, +358 29 370 0150 DIR Henri von Haartman, hvh@nanoform.com, +46 76866 50 11 Nanoform.com | @nanoform