Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — SEB Annual Healthcare Seminar 2023
63 slides from Nanoform Finland Oyj's conference presentation, Nov 23, 2023
Slide 1: Nanoform Management Presentation
Nanoform Management Presentation SEB Annual Healthcare Seminar Stockholm November 23, 2023
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: Short Introduction to Nanoform
Nanoform Breaker Slide SHORT Option 2 INTRODUCTION TO NANOFORM 3 Nanoform.com | @nanoform
Slide 4: Nanoform in a Snapshot
Nanoform in a Snapshot The Share Nanoform Platform Technology ➢ Listed June 4th, 2020, on Nasdaq ➢ Global experts in nanotechnology and drug ➢ CESS® technology for small First North Premier Growth particle engineering molecules Market in Helsinki and Stockholm ➢ ~165 employees, ~35 nationalities, ~3
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 2010-2022 Global pharmaceutical R&D spending 2014-2028E (USDbn) Chemical Biologics 300 60 278 285
Slide 6: 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 7: 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 8: Small molecules - Small is powerful
Small molecules - Small is powerful® 8 Nanoform.com | @nanoform
Slide 9: 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 10: Highlights
Nanoform Breaker Slide Option 2 HIGHLIGHTS 10 Nanoform.com | @nanoform
Slide 11: Nanoform from June 2020 IPO to September 2023
Nanoform from June 2020 IPO to September 2023 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 11 Nanoform.com | @nanoform
Slide 12: 2023 highlights
2023 highlights ✓ Project Blockbuster is progressing well (license/commercial supply agreements target is during 2024) ✓ Strong business opportunity identified within Amorphous Solid Dispersions (ASDs) ✓ STARMAP® licensed to AstraZeneca Plc ✓ Customer Targtex’s nanoformed drug candidate receives FDA
Slide 13: Project Blockbuster – a potential game changer for Nanoform
Project Blockbuster – a potential game changer for Nanoform 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 to during Q1/2024 supply agreements Clinical manufacture of commence dur
Slide 14: Project Blockbuster and Amorphous Solid Dispersions (ASD's)
Project Blockbuster and Amorphous Solid Dispersions (ASD’s) The marketed drug formulation is an amorphous solid dispersion (ASD) The nanoformed & nanocrystalline formulation offers an attractive alternative to the ASD with: substantially higher drug load in the final drug product reduced pill bu
Slide 15: Commercial
Nanoform Breaker Slide COMMERCIAL Option 2 CFO 15 Nanoform.com | @nanoform
Slide 16: Recent customer news – large pharma
Recent customer news – large pharma • Nanoform granted AstraZeneca Plc a global online • AstraZeneca to screen with STARMAP® its STARMAP® license molecules from drug discovery through to lifecycle management • Nanoform has access to AstraZeneca Plc compound libraries and large data sets - screening
Slide 17: Recent customer news - biotechs
Recent customer news - biotechs ✓ 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 orphan drug designation follows the generation of a preclinical rodent data package in which a surv
Slide 18: 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 19: Examples of areas where STARMAP sees strong potential
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 20: 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 21: Nanocrystallization of amorphous nanoparticles
Nanocrystallization of amorphous nanoparticles CEO 21 Nanoform.com | @nanoform
Slide 22: Amorphous vs. Crystalline
Amorphous vs. Crystalline ➢ Crystalline Drug: Amorphous dispersions: • Low solubility • Increased dissolution rate • Stable • Typically, >50% polymer with significant volumes of organic solvents (spray drying). • Low levels of crystallinity can reduce the degree of supersaturation: loss of solubilit
Slide 23: A new way to produce stable nanocrystals
A new way to produce stable nanocrystals ✓ No polymers / excipients. Direct Crystallization via CESS® Process ✓ Stable to changes in particle properties. ✓ No organic solvent waste. Crystalline API ✓ Tight particle size control. 5 µm Nanoformed amorphous nanoparticles Stable crystalline DPI ✓ High A
Slide 24: Project blockbuster: intermediate product matches ASD exposure in-vivo and is stable
Project blockbuster: 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 are sta
Slide 25: Financials
FINANCIALS Nanoform Breaker Slide Option CFO 2 25 Nanoform.com | @nanoform
Slide 26: 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 26
Slide 27: Cumulative nr of projects signed
Cumulative nr of projects signed 27
Slide 28: Revenue recognized impacted by slow signings in 2H22
Revenue recognized impacted by slow signings in 2H22, marginal impact on rolling 12m 28
Slide 29: 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). 29
Slide 30: Improvement in operating free cash flow continued in 3Q
Improvement in operating free cash flow continued in 3Q +10% +26% +19% +19% 30
Slide 31: Operating free cash flow trend towards 2025 target on track
Operating free cash flow trend towards 2025 target on track 31
Slide 32: 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 32 Nanoform.com | @nanoform
Slide 33: Nanoform Factory Tour
By Invitation Only Nanoform Factory Tour Tuesday January 16th at 09.00-10.30 EEST Tuesday January 30th at 09.00-10.30 EEST 1-1 Tours arranged upon date request Nanoform welcomes stakeholders to Nanoform’s headquarters and state of the art nanoscale medicine factory (15 min from airport and 15 min fr
Slide 34: Q & A
Nanoform Breaker Slide Q & A2 Option www.nanoform.com San Diego - New York - Lisbon - Oxford – London - Cambridge - Bordeaux - Stockholm - Helsinki 34 Nanoform.com | @nanoform
Slide 35: Appendix
APPENDIX 35 Nanoform.com | @nanoform
Slide 36: 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 and patients through and drug particle 39 PhD’s in US, experience of institutional game-changing e
Slide 37: Proprietary platform technology
Proprietary platform technology Small Large Formulation AI molecules molecules Nanoform CESS®* Our unique biologic Full therapeutic STARMAP® online is technology enables nanoparticles enable potential is unlocked the digital twin of our new medicines improved with nano-formulated CESS® process. It t
Slide 38: 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 39: 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 39 The CESS® technology platform was described in detail in the IPO p
Slide 40: 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 41: Large molecules - Proprietary technology
Large molecules - Proprietary technology Green technology Nanoforming process for biologics API = active pharmaceutical ingredient 41 Nebulization = turns liquid into mist Nanoform.com | @nanoform Ionization = particles electrically charged
Slide 42: 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 43: 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 44: 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 45: 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 46: Nr of opportunities and proposals issued
Nr of opportunities and proposals issued 46
Slide 47: 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 48: Effect on gross margin excluding Blockbuster project
…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 49: IT expenses reduced after successful SAP implementation
IT expenses reduced after successful SAP implementation 49
Slide 50: KPI's
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 51: 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 52: Drug count
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 5,995 6,198 6,416 5,000 2001 2002 2003 2004 2005 2006 2007 200
Slide 53: Company count
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 54: 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 55: Upcoming investor events and presentations
Upcoming investor events and presentations Nov 22, 2023 Q2 2023 interim report Nov 22, 2023 Financial Hearings webcast presentation at 15.00 EEST: https://ir.financialhearings.com/nanoform-q3-report-2023 Nov 23, 2023 Presentation and 1-1’s at SEB Healthcare Seminar, Stockholm (in person) Nov 29, 202
Slide 56: Commercial Relationships 2019 to 3Q 2023
Commercial Relationships 2019 to 3Q 2023 10 major pharma (50% of top-20) 26 mid-sized, specialty pharma & biotech companies 1 co-development 3 collaborations 56 6 new clients in Jan-Sep 2023 Nanoform.com | @nanoform
Slide 57: A Selection of Nanoform Pharmaceutical Partnerships
A Selection of Nanoform Pharmaceutical Partnerships 10 of the top 20 Major Pharma and many Biotechs including 57 Nanoform.com | @nanoform
Slide 58: 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 59: 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 60: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders 60 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ Nanoform.com | @nanoform
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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