Slide 1: Nanoform Management Presentation Q2 2023 Interim Report
Nanoform Management Presentation Q2 2023 Interim Report August 24th, 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 ➢ ~160 employees, ~30 nationalities, ~3
Slide 5: 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 $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 - 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 8 The CESS® technology platform was described in detail in the IPO pr
Slide 9: Small molecules - Small is powerful
Small molecules - Small is powerful® 9 Nanoform.com | @nanoform
Slide 10: Large molecules – Small is now possible in biologics too
Large molecules – Small is now possible 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 i
Slide 11: Large molecules - Proprietary technology
Large molecules - Proprietary technology Green technology Nanoforming process for biologics API = active pharmaceutical ingredient 11 Nebulization = turns liquid into mist Nanoform.com | @nanoform Ionization = particles electrically charged
Slide 12: 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 13: 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 14: CEO Review
Nanoform Breaker Slide CEOOption REVIEW2 14 Nanoform.com | @nanoform
Slide 15: A record 11 new customer projects signed in Q2
A record 11 new customer projects signed in Q2 and targeting first license/commercial supply agreement in 2024 GMP manufacture for “Project Marketing Authorization application A record 11 new Blockbuster'' is being completed. Bulk submitted to FIMEA*. customer projects API Targeted timeline for one
Slide 16: Project Blockbuster – a potential game changer for Nanoform
Project Blockbuster – a potential game changer for Nanoform If the read-out is positive, Read-out is the targeted timeline for expected in one or several Clinical trials Q1 2024. are expected to license/commercial The produced commence in supply agreements is Q4 2023. during 2024. nanomaterial will
Slide 17: 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 18: 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 18 Nanoform.com | @nanoform
Slide 19: Commercial
Nanoform Breaker Slide Option 2 COMMERCIAL 19 Nanoform.com | @nanoform
Slide 20: 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 21: Nanoform – 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 22: 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 5,995 6,198 6,416 5,000 2001 2002 2003 2004 2005 2006 2007 200
Slide 23: 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 24: 17 new projects signed in H1
Strong project intake 17 new projects signed in H1, both with new and repeat customers US Europe Japan 6 new projects in Q1 and 11 new projects in Q2 Nanoform.com | @nanoform
Slide 25: Commercial Relationships 2019 to Q2 2023
Commercial Relationships 2019 to Q2 2023 10 major pharma companies 26 mid-sized, specialty pharma & 1 co-development biotech companies 3 collaborations 25 6 new clients in H1 (3 new clients in Q1 and 3 new clients in Q2) Nanoform.com | @nanoform
Slide 26: A Selection of Nanoform Pharmaceutical Partnerships
A Selection of Nanoform Pharmaceutical Partnerships 10 of the top 20 Major Pharma and many Biotechs including 26 Nanoform.com | @nanoform
Slide 27: Monoclonal Antibodies (mAb's)
Monoclonal Antibodies’ (mAb’s) These results further strengthen our We conducted proposition that promising initial nanoparticles are in-vitro trials with relevant for 2 major pharma improved product companies looking development and at monoclonal more patient centric antibodies commercial products
Slide 28: Small is a powerful ingredient in formulation: Celanese, TargTex
Small is a powerful ingredient in formulation Celanese TargTex • Nanoform and Celanese collaboration • Customer TargTex hit another important milestone demonstrated significant reduction in the initial in July. burst effect seen commonly in high drug load • TargTex had a pre-IND meeting with the FDA
Slide 29: Project Blockbuster – a potential game changer for Nanoform
Project Blockbuster – a potential game changer for Nanoform If the read-out is positive, Read-out is the targeted timeline for expected in one or several Clinical trials Q1 2024. are expected to license/commercial The produced commence in supply agreements is Q4 2023. during 2024. nanomaterial will
Slide 30: Financials
Nanoform Breaker Slide Q2 2023 Option 2 FINANCIALS 30 Nanoform.com | @nanoform
Slide 31: Nr of employees & nr of lines
Nr of employees & nr of lines GMP lines 2&3 will be commissioned after inspection by Fimea, expected later in 2023. 31 31 Nanoform.com | @nanoform
Slide 32: Customer momentum returned in 4Q22 and has continued
Customer momentum returned in 4Q22 and has continued 32 Nanoform.com | @nanoform
Slide 33: Record signings in 2Q23
which led to record signings in 2Q23 33 Nanoform.com | @nanoform
Slide 34: Rolling 6 month signings back at growth trend
Rolling 6 month signings back at growth trend 34 Nanoform.com | @nanoform
Slide 35: Our Experience, Expertise & Efficiency continues its fast growth
Our Experience, Expertise & Efficiency continues its fast growth Cumulatively we have >10 000hrs of experience running nanoforming lines 35 Nanoform.com | @nanoform
Slide 36: Revenue recognized impacted by slow signings in 2H22
Revenue recognized impacted by slow signings in 2H22, marginal impact on rolling 12m 36 Nanoform.com | @nanoform
Slide 37: 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). 37 Nanoform.com | @nanoform
Slide 38: Project Blockbuster has led to increased external GMP QC cost
Project Blockbuster has led to increased external GMP QC cost Excluding the cost of external GMP QC services, related to the Blockbuster project, our underlying materials & services costs have remained between EUR 30-60k per quarter. In June, Nanoform submitted a notification to the Finnish Medicine
Slide 39: IT expenses has fallen back after successful SAP implementation
IT expenses has fallen back after successful SAP implementation 39 Nanoform.com | @nanoform
Slide 40: Improvement in operating free cash flow continued in 2Q
Improvement in operating free cash flow continued in 2Q +10% +22% +19% 40 Nanoform.com | @nanoform
Slide 41: Financial KPI's
Financial KPI’s 41 Nanoform.com | @nanoform
Slide 42: Operational KPI's
Operational KPI’s 42 Nanoform.com | @nanoform
Slide 43: Income Statement
Income Statement 1-6/2023 comments ➢ Revenue fell by 8 % to EUR 1,524 thousand (1,650) as a result of slower project intake during 2H22. The revenue stemmed from 28 different customer projects (28 projects in 1H22). Revenues are recognized over the lifetime of the projects, based on expenses (mostly
Slide 44: Q & A
Nanoform Breaker Slide Q & A2 Option www.nanoform.com San Diego - New York - Lisbon - Oxford – London - Cambridge - Bordeaux - Stockholm - Helsinki 44 Nanoform.com | @nanoform
Slide 45: Appendix
APPENDIX 45 Nanoform.com | @nanoform
Slide 46: 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 47: Nanoform from June 2020 IPO to June 2023
Nanoform from June 2020 IPO to June 2023 IPO June 2020 June 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 47 Nanoform.com | @nanoform
Slide 48: Nanoform customer projects – therapy area overview
Nanoform customer projects – therapy area overview* Pre-Clinical Phase I Phase II & III Marketed Immunology/ Cardiology Metabolism and Endocrinology Infectious Disease Inflammation Immunology/ Gastroenterology Dermatology Neurology (CNS) Inflammation Immunology/ Neurology (CNS) Oncology Inflammation
Slide 49: Small is sustainable
Small is sustainable Climate change is an environmental and a public health challenge. The healthcare sector accounts for ~5% of global greenhouse gas emissions, the equivalent of a small country. The pharmaceutical industry has an obligation Nanoform Breaker Slide to innovate and evolve, placing su
Slide 50: Small is sustainable – STARMAP
Small is sustainable Climate change is an environmental and a public health challenge. The healthcare sector accounts for ~5% of global greenhouse gas emissions, the equivalent of a small country. The pharmaceutical industry has an obligation STARMAP® enables us to screen thousands of APIs Nanoform
Slide 51: 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 52: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders 52 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ Nanoform.com | @nanoform
Slide 53: Not Your Grandparents' Drugs
“Not Your Grandparents’ Drugs” How Drugs Changed Since the 70’s and What to Do About It: https://www.youtube.com/watch?v=nXcs3Irk7Q0 Dr. Dennis Hu Dr. Chris Worrall CEO Vice President Christian Jones, FRSC Chief Commercial Officer Nanoform US Business Development Nanoform 53 Nanoform.com | @nanoform
Slide 54: Thank you
FINANCIAL CALENDAR • Aug 24, 2023 - Q2 2023 interim report • Aug 24, 2023 - Financial Hearings webcast presentation at 15.00 EEST: https://ir.financialhearings.com/nanoform-q2-2023 • Sep 4, 2023 - Presentation and 1-1 ‘s at SEB Stockholm (in person) • Sep 5, 2023 - Presentation at Danske Bank (digit