Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — SEB Nordic Seminar Copenhagen 2024
63 slides from Nanoform Finland Oyj's conference presentation, Jan 9, 2024
Slide 1: Nanoform Management Presentation
Nanoform Management Presentation SEB Nordic Seminar Copenhagen January 9, 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: Key Topics at SEB Nordic Seminar Copenhagen
KEY TOPICS AT SEB NORDIC SEMINAR COPENHAGEN ➢ Nanoform technologies ➢ Highlights ➢ Project Glioblastoma ➢ Project Nanoenzalutamide (“Blockbuster”) ➢ Nanoforming Amorphous Solid Dispersions (ASDs) ➢ Financials 3 Nanoform.com | @nanoform
Slide 4: Short Introduction to Nanoform
Nanoform Breaker Slide SHORT Option 2 INTRODUCTION TO NANOFORM 4 Nanoform.com | @nanoform
Slide 5: 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 35 nationalities, combined sheet & patients through & drug particle 39 PhD’s in US, experience of institutional game-changing engin
Slide 6: Proprietary platform technology
Proprietary platform technology 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® proce
Slide 7: 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 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 better bioavailability of a drug ➢ The surface area increases 30 fold from a 10 micron1 sized par
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 unsuccessful Improving Enabling drug candidates a existing new drugs second chance drugs > 20,000 > 58,000 failed > 5,800 drugs in drugs in the l
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: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders 13 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ Nanoform.com | @nanoform
Slide 14: Highlights
Nanoform Breaker Slide HIGHLIGHTS Option 2 14 Nanoform.com | @nanoform
Slide 15: Nanoform from June 2020 IPO to September 2023
Nanoform from June 2020 IPO to September 2023 Q4 and FY2023 results due February 29th, 2024 IPO June 2020 Sept 2023 Growth Bulk API Employees 50 ~160 ~3x Manufacturing lines 5 ~20 ~4x Customers enrolled 5 ~40 ~8x Nanoformed API Customer projects started 5 ~60 ~12x 15 Nanoform.com | @nanoform
Slide 16: 2023 Highlights
2023 Highlights Q4 and FY2023 results due February 29th, 2024 ✓ Project Nanoenzalutamide* (“Blockbuster”) is progressing well ✓ Strong business opportunity identified within Amorphous Solid Dispersions (ASD) ✓ STARMAP® licensed to AstraZeneca Plc ✓ Project Glioblastoma - customer Targtex’s nanoforme
Slide 17: Commercial Relationships 2019 to 3Q 2023
Commercial Relationships 2019 to 3Q 2023 Q4 and FY2023 results due February 29th, 2024 10 major pharma 26 mid-sized, (50% of top-20) specialty pharma & biotech companies 1 co-development 3 collaborations 17 6 new clients in Jan-Sep 2023 Nanoform.com | @nanoform
Slide 18: Selection of Nanoform Pharmaceutical Partnerships
Selection of Nanoform Pharmaceutical Partnerships - 10 of the top 20 Major Pharma and many Biotechs including 18 Nanoform.com | @nanoform
Slide 19: Cumulative nr of projects signed
Cumulative nr of projects signed
Slide 20: Project Glioblastoma
Nanoform Breaker Slide PROJECT Option 2 GLIOBLASTOMA 20 Nanoform.com | @nanoform
Slide 21: 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 22: Project Nanoenzalutamide
Nanoform Breaker Slide PROJECT Option 2 NANOENZALUTAMIDE 22 Nanoform.com | @nanoform
Slide 23: Project Nanoenzalutamide – a potential breakthrough
Project Nanoenzalutamide – a potential breakthrough Q1 2024 Existing blockbuster drug Nanoformed drug Xtandi®* Nanoenzalutamide • The development and commercialization • Xtandi® - #1 prescribed androgen of a more patient centric drug receptor inhibitor, approved by FDA in 2012 to treat prostate canc
Slide 24: Relative Bioavailability Study of Nanotechnology-Enhanced Reformulation of Enzalutamide
Relative Bioavailability Study of Nanotechnology-Enhanced Reformulation of Enzalutamide • First Subject First Visit (FSFV) done – study results expected in 1Q 2024 • Trial to evaluate the relative bioavailability of a nanotechnology enabled amorphous solid dispersion (ASD) re- formulation of Nanoenz
Slide 25: Project Nanoenzalutamide – near-term timeline
Project Nanoenzalutamide – near-term timeline 2024 Q1 2024 If the read-out is Q4 2023 positive, the targeted timeline Clinical trial read- for one or several Q3 2023 out expected license/commercial Clinical trials during Q1/2024 supply agreements Clinical manufacture of commenced is during 2024 nano
Slide 26: Nanoforming Amorphous Solid Dispersions
NANOFORMING Nanoform Breaker Slide AMORPHOUS SOLID Option 2 DISPERSIONS 26 Nanoform.com | @nanoform
Slide 27: Project Nanoenzalutamide and Amorphous Solid Dispersions
Project Nanoenzalutamide and Amorphous Solid Dispersions Project Nanoenzalutamide: development and commercialization of a more patient centric and a nanoformed version of an existing amorphous solid dispersion (ASD) blockbuster drug called Xtandi Nanoformed and nanocrystalline drugs (e.g. Nanoenzalu
Slide 28: 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 29: Areas in which 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 30: Financials
Nanoform Breaker Slide FINANCIALS Option 2 Q4 and FY2023 results due February 29th, 2024 30 Nanoform.com | @nanoform
Slide 31: Nr of employees & nr of lines
Nr of employees & nr of lines GMP2&3 will be commissioned after inspection by Fimea, expected during 1Q 2024 31
Slide 32: Revenue recognized impacted by slow signings in 2H22
Revenue recognized impacted by slow signings in 2H22, marginal impact on rolling 12m 32
Slide 33: Nr of projects generating revenue
Nr of projects generating revenue* *Impact on revenue can in a quarter for some of the projects be negative if budgeted costs increase significantly (often related to hours worked). 33
Slide 34: Improvement in operating free cash flow continued in 3Q
Improvement in operating free cash flow continued in 3Q +10% +26% +19% +19% 34
Slide 35: Operating free cash flow trend towards 2025 target on track
Operating free cash flow trend towards 2025 target on track 35
Slide 36: Q & A
Nanoform Breaker Slide Q & A2 Option www.nanoform.com San Diego - New York - Lisbon - Oxford – London - Cambridge - Bordeaux - Stockholm - Helsinki 36 Nanoform.com | @nanoform
Slide 37: Appendix
APPENDIX 37 Nanoform.com | @nanoform
Slide 38: Nanoform grants AstraZeneca Plc STARMAP license
Nanoform grants AstraZeneca Plc STARMAP® license • AstraZeneca to screen with STARMAP® its molecules from drug discovery through to lifecycle management • Nanoform has access to AstraZeneca compound libraries and large data sets => Nanoform to screen and propose innovative product development concep
Slide 39: Nanoenzalutamide intermediate product matches ASD exposure in-vivo and is stable
Project Nanoenzalutamide: Nanoform’s intermediate product matches ASD exposure in-vivo and is stable Equivalent exposure after oral administration Performance and stability • Equivalent exposure compared to ASD product, after oral suspension administration in rodents • Polymorph and particle size ar
Slide 40: Major pharma companies with ASD drugs in the market
A selection of major pharma companies with ASD drugs in the market 40 Nanoform.com | @nanoform
Slide 41: 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 42: Nanoform near-term business targets 2023
Nanoform near-term business targets 2023 Topic Target Status Bulk API “ Increased number of non-GMP and GMP Customer Projects On track projects signed in 2023 vs 2022 ” * Nanoformed “ Improved operating Operating API free cashflow On track Free Cashflow in 2023 vs 2022 ” ** GMP = Good Manufacturing
Slide 43: 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 43 Nanoform.com | @nanoform
Slide 44: 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 45: 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 46: Nanoform educational material
Nanoform educational material VIDEOS PODD 2022 Video – “How drug delivery is enabling a clinical trial for Glioblastoma” – TargTex CEO João Seixas and Nanoform CCO Christian Jones present promising data enabled by a nanoformed drug product for the treatment of glioblastoma multiforme (GBM): https:/
Slide 47: 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 47 The CESS® technology platform was described in detail in the IPO p
Slide 48: Large molecules – Small is powerful in biologics too
Large molecules – Small is powerful in biologics too Our unique biological nanoforming technology can produce drug particles as small as 50 nm in diameter while retaining biological activity. It is a gentle bottom-up process, and its effectiveness has been demonstrated on peptides and proteins in th
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: Global drug R&D pipeline size and growth
Global drug R&D pipeline size and growth 21,192 drugs 22 500 20 109 20 000 18 582 17 737 17 500 16 181 15 267 Drug count 14 872 15 000 13 713 12 300 12 500 11 307 10 452 10 479 9 605 9 737 9 713 10 000 9 217 7 737 7 360 7 406 7 500 6 994 6 198 6 416 5 995 5 000 2001 2002 2003 2004 2005 2006 2007 200
Slide 51: Global number of companies with active pipelines
Global number of companies with active pipelines 5,529 companies 6 000 5 416 5 529 5,099 5 000 4 816 Company count 4 323 4 134 4 003 4 000 3 687 3 286 2 984 3 000 2 705 2 745 2 387 2 207 2 084 1 965 2 000 1 769 1 620 1 633 1 313 1 503 1 576 1 198 1 000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20
Slide 52: 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 53: Nanoform GMP Manufacturer's Authorization
Nanoform GMP Manufacturer’s Authorization GMP Manufacturer’s Authorization April 2020, by FIMEA: Human Investigational Medicinal products: GMP manufacturing/nanoforming API for clinical trial GMP Manufacturer’s Authorization May 2023, by FIMEA: Human Investigational Medicinal products: GMP manufactu
Slide 54: Nr of projects signed
Nr of projects signed 12 10 1Q20 Nr of projects signed 3 2 2 2 2 1 Non-GMP projects signed a q & 3 MP projects signed 1Q23 10 a 3Q23 25 20 15 10 a 1Q20 2Q20 Nr of projects signed - rolling 12 months 2a ai a DB 5 eessx23e8s3e88 8 és ¢ $$ ¢ § & € = § &® $< 3 &§ ® F< SRK & Nr of GMP projects signed - r
Slide 55: Nr of opportunities and proposals issued
Nr of opportunities and proposals issued 55
Slide 56: Project Blockbuster has led to increased external GMP QC cost
Project Blockbuster has led to increased external GMP QC cost, (will be mitigated once GMP-QC gets FIMEA approval) Excluding the cost of external GMP QC services, related to the Blockbuster project, our underlying materials & services costs have remained between low. In June, Nanoform submitted a no
Slide 57: Excluding Blockbuster project, gross margin was >90%
…which had an effect on the gross margin. Excluding the Blockbuster project, gm was > 90% Excluding the cost of external GMP QC services, related to the Blockbuster project, our underlying in 9M23 gross margin was >90%. In June, Nanoform submitted a notification to the Finnish Medicines Agency (Fime
Slide 58: IT expenses reduced after successful SAP implementation
IT expenses reduced after successful SAP implementation 58
Slide 59: Financial and operational KPIs
Financial KPI's EUR thousand Operational KPI's 7-9/2023 7-9/2022 1-9/2023 1-9/2022 1-12/2022 1-12/2021 1-12/2020 7-9/2023 7-9/2022 1-9/2023 1-9/2022 1-12/2022 1-12/2021 1-12/2020 10 ‘Total number of new customer projects 15 Ss nanoform 20 v7 v 19 5 ‘Total number of lines (end of period) nanoform.com
Slide 60: Income statement
Income statement 1-9/2023 comments ➢Revenue came in at EUR 2.2 million, stemming from 32 different customer projects (EUR 2.5m, 33 projects in 1–9/2022). ➢The gross profit decreased to EUR 1.4 million, with a gross margin of 66% (EUR 2.3 million, 93%) due to GMP QC costs related to the Blockbuster p
Slide 61: 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 62: 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 senior p
Slide 63: 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 Thank you Nanoform.com | @nanoform
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