Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — Investor Day (June 2021)
50 slides from Nanoform Finland Oyj's investor day presentation, Jun 4, 2021
Slide 1: Nanoform Capital Markets Day
Nanoform Capital Markets Day June 4th, 2021 14.00-16.00 Helsinki time
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: Agenda – all presentations in real time!
Agenda – all presentations in real time! 1. Prof. Edward Hæggström CEO 4. CCO Christian Jones Commercial & Team 2. Miguel Calado Chairman of the Board 5. Mike Rea Strategic Innovation Advisor 3. Live Tour: … 6. Dr. Maria Lume Biologics Dr. Niklas Sandler Chief Technology Officer Tuomas Puranen Proce
Slide 4: Nanoform – 12-month rapid progress
Nanoform – 12-month rapid progress Nanoform – 12-month rapid progress Prof. Edward Hæggström CEO
Slide 5: Nanoform 12-month rapid progress
Nanoform 12-month rapid progress June 4th, 2020 June 4th, 2021 9 23 50 nationalities 100 nationalities based in employees based in 4 employees 6 and growing countries countries 7 12 manufacturing manufacturing 18 lines 32 lines PhD’s 6 PhD’s 18 customer customer projects projects started started 5
Slide 6: Nanoform Clients & Collaborations
Nanoform Clients & Collaborations June 4th, 2020 June 4th, 2021 Tier 2 – Mid-sized Tier 2 – Mid-sized and specialty UK and specialty respiratory pharma and biotech pharma and biotech biotech UK biotech UK biotech US Major Pharma Tier 1 – Global US Major Tier 1 – Global large pharma West Pharma Coast
Slide 7: Nanoform Global Commercial Team
Nanoform Global Commercial Team June 4th, 2021 June 4th, 2020 Chicago Vice President Business Cambridge Helsinki Development Chief Commercial Commercial Helsinki Sergie Letser Officer Associate Commercial Associate Christian Jones Britta Madison Britta Madison New York Vice President Business Cambri
Slide 8: Nanoform new mid-term business targets 2025
Nanoform new mid-term business targets 2025 35 lines >70 new APIs of which 200-250 7-14 are employees per year GMP compliant Up 0-25% +40% vs previous target vs previous target +40% (~200) (>50) vs previous target (25; 5-10 GMP) >90% Cash flow gross positive margin Unchanged Unchanged API = Active P
Slide 9: Nanoform – 12-month rapid progress: Miguel Calado
Nanoform – 12-month rapid progress Nanoform – 12-month rapid progress Miguel Calado Chairman of the board
Slide 10: Live Tour
Live Tour 1. Research & Development Dr. Niklas Sandler Chief Technology Officer CESS® Technology Tuomas Puranen Process Engineer 2. Quality Control Director Antonio Da Silva Quality Control Director Solid State Characterization Dr. Eric Kissi Quality Control Scientist 3. Pharmaceutical Development D
Slide 11: Nanoform – 12-month rapid progress: Commercial
Nanoform – 12-month rapid progress Nanoform – 12-month rapid progress Christian Jones Chief Commercial Officer Commercial
Slide 12: Nanoform Global Commercial Team
Nanoform Global Commercial Team Helsinki Commercial Associate Britta Madison Chicago Vice President Business Development Oxford Sergie Letser Commercial Insights Officer Dr. Jamie Unwin San Diego Vice President Cambridge Business Development Chief Commercial Officer Dr. Chris Worrall Christian Jones
Slide 13: Nanoform unlocks possibilities for patient-centric innovation
Nanoform unlocks possibilities for patient-centric innovation Setting the North Star Adherence to long- Nanoforming empowers the adoption of term therapy for “North Star TPPs” that meet patient chronic illnesses in demands from the start of development. developed True patient-centric innovation need
Slide 14: A platform technology which addresses an evolving market
A platform technology which addresses an evolving market Small Molecule % Global Sales 2012 2026 61% 45% # small molecules launched # biologics launched 100 45 90 40 7% 80 40% 35 70 3% 61% 30 15% 15% 60 51% 46% 3% 25 50 64% 20 40 30 15 20 10 10 5 0 0 2016 2017 2018 2019 2020 2016 2017 2018 2019 2020
Slide 15: We know where opportunity is and how our technology can support it
We know where opportunity is and how our technology can support it… 2% 2% NxEs 6% 5% Reformulations Injectable (IV) 5% n=554 6% n=42 2% 29% Oral Injectable (SC) 46% 12% Preference for Injectable (other) More heterogeneous innovators to pursue approaches adopted “tried and tested” Transdermal oral an
Slide 16: YTD Opportunities by Clinical Phase
YTD Opportunities by Clinical Phase n=57 Pipelines by phase NF opportunities closely 60 mirror the market in terms of development 50 phase with most emphasis on tackling 40 % Pipeline solubility/bioavailability 30 issues in preclinical and phase 1 and adding value 20 to marketed products in lifecycl
Slide 17: Small is a platform enabler across drug delivery
Small is a platform enabler across drug delivery Rapid absorption of poorly soluble Piroxicam NPI-001 and NPI-002 enhanced ocular tissue penetration Localised lung delivery UK Respiratory Biotech Co-Polymer Oral Tablet Oral Buccal Respiratory Nasal Ophthalmics Drug Delivery Rapid absorption of poorl
Slide 18: Opportunities in biologics: Mike Rea
Nanoform – 12-month rapid progress Nanoform – 12-month rapid progress Mike Rea Nanoform - Strategic Innovation Advisor CEO, IDEA Pharma An overview of the opportunities in biologics
Slide 19: Nanoforming a potential game-changer in Biologics too
Nanoforming a potential game-changer in Biologics too Drug Improving Tailored loading delivery release capacity in route profiles formulations Implementing Enabling new lighter Improving drug infrastructure uptake combinations for drug logistics Source: Company information 19
Slide 20: Processing of biologics at Nanoform
Nanoform – 12-month rapid progress Nanoform – 12-month rapid progress Dr. Maria Lume Biologics Team Leader Processing of biologics at Nanoform
Slide 21: The BIO team
The BIO team ➢ Production of bio-nanoparticles ➢ Formulation of bio-nanoparticles ➢ Characterization and qualitative analysis of the bio-nanoparticles 21
Slide 22: Nanoforming biologics
Nanoforming biologics Gentle, bottom-up process So far used for processing peptides and proteins ranging from 6 to 140 kDa in size (range Nanoparticles of biologics expanded from 6 to 66 kDa during Q2/2021) Nanoparticles as small as 50 nm are produced 85nm 55nm 131nm 203nm Batches per year 700 Produ
Slide 23: Tuning the particle size of HSA
Tuning the particle size of HSA D50=178 nm D50=786 nm D50=1360 nm 23
Slide 24: Nanoforming insulin
Nanoforming BULK NANO insulin 24
Slide 25: Assessment of insulin activity in cellular assays
Assessment of insulin activity in cellular assays The activity of bulk unprocessed insulin and Upon activation, protein’s phosphorylation levels change nanoformed insulin was compared in vitro, Phosphorylated protein = active signal-transmitting protein using HepG2 cell-line De Meyts 2016 HepG2 cell
Slide 26: Processed insulin 1-month stability assessment
Processed insulin 1-month stability assessment Fresh samples 1-month old processed samples 1000 Lantus BULK NANO_1 NANO_2 1 x LD 1000 1000 1000 200 200 200 500 500 500 Insulin nM 0 0 0 75 kDa pAKT 50 kDa 75 kDa Total AKT 50 kDa ➢ Both unprocessed and processed insulin activate IR and the downstream
Slide 27: LDH – Lactate dehydrogenase
LDH – Lactate dehydrogenase Lactic dehydrogenase Comprises of 4 subunits, molecular weight 140kDa LDH catalyses the interconversion of pyruvate and lactate. Highly sensitive to shear and temperature Used to evaluate the presence of damage and toxicity of tissue and cells. pH 7.5 LDH is elevated in c
Slide 28: Assessing LDH size and retained activity
Assessing LDH size and retained activity First results on LDH activity assay 0.7 stock 0.6 nanoformed Absorbance (A450 nm) 0.5 min after lyophilization max after lyophilization 0.4 Lyophilization min/max adopted from: 0.3 Strøm Larsen, 2019, Pharm Dev Technol Tuderman, 2018, Int J Pharm 0.2 Fang, 20
Slide 29: Future prospects
Future prospects Building of additional lines to support commercial projects. Broadening the product portfolio capabilities e.g., by processing antibodies etc. Supporting expansion towards GMP for biologicals. 29
Slide 30: Dr. Elisabetta Micelotta, Science & Technology Team Leader
Dr. Elisabetta Micelotta Science & Technology Team Leader 30
Slide 31: STARMAP Explained
Explained Nanoform’s cutting-edge sparse-data AI platform Potential new identifies winners opportunities for our (molecules): pharma partners: • Revisiting drug candidates unnecessarily • Molecules predicted to be best amenable discarded by AIs trained on old particle to CESS®-powered nanoforming. e
Slide 32: The process
The process If insufficient amount of data STARMAP® 2.0: Experimental results ↓ augmented with detailed expert knowledge No specific predictions ↓ possible Sensible predictions regarding ↓ drug development success Help from sparse-data AI Digital version of CESS® technology • Large number of in-sili
Slide 33: Inputs and outputs
Inputs and outputs Solubility in sc-CO2 * Input molecule High Low Propensity to crystallize * Prof. Louis Messerle, Chemistry Department, University of Iowa 33
Slide 34: Solubility Prediction in sc-CO2
Solubility Prediction in sc-CO2 Very good match between predictions & measurements Compound B Solubility Solid lines → Solubility predictions. Filled circles → Solubility measurements. Shaded areas → Uncertainty in predictions. Solubility vs. Density Different colors → Different Density of sc-CO2 te
Slide 35: Required Data & Data Structure
Required Data & Data Structure Input: Standard properties & Experimental data Solubility Simple Input data structure Secure data transfer 35
Slide 36: A continuous growth
A continuous growth 1 Million evaluations per week Expert knowledge + 1000 Artificial Intelligence evaluations ↓ per week Growth Starmap2.0 launched 10 evaluations per week 2020 2021 2025 36
Slide 37: Nanoform – 12-month rapid progress: Albert Hæggström
Nanoform – 12-month rapid progress Nanoform – 12-month rapid progress Albert Hæggström Chief Financial Officer
Slide 38: Nanoform is here to fill the gap
Nanoform is here to fill the gap Giving unsuccessful drug candidates Improving Enabling new a second chance existing drugs drugs >58 000 failed >5 800 >18 000 drugs drugs in the last existing drugs in development 40 years Source: Nanoform and Pharmaprojects® | Informa, 2021 38
Slide 39: Global drug R&D pipeline size and growth
Global drug R&D pipeline size and growth 18,582 drugs 20,000 2016-2021 growth 36% (6.3% p.a.) 17,737 17,500 16,181 15,267 2011-2016 growth 14,872 15,000 41% (7.1% p.a.) Drug count 13,713 12,300 12,500 2006-2011 growth 31% (5.6% p.a.) 11,307 10,452 10,479 2001-2006 growth 9,737 9,713 10,000 9,605 24%
Slide 40: Global drug development by phase, 2021
Global drug development by phase, 2021 Other* 10% Phase III 6% Phase II 15% Preclinical 55% Phase I 14% *Launched and in development (7%), Pre-registered (1%), Registered (1%) and Suspended & N/A (1%) Source: Pharmaprojects® | Informa, 2021 40
Slide 41: Global clinical drug development phase trends, 2007-2021
Global clinical drug development phase trends, 2007-2021 152% 12000 +182% 10738 10000 8000 Drug Count 6000 3803 +152% +102% 4000 2676 2747 2000 1360 +131% 1060 1029 446 0 Preclinical Phase I Phase II Phase III 2007-2021 per phase Source: Pharmaprojects® | Informa, 2021 41
Slide 42: Global number of companies with active pipelines
Global number of companies with active pipelines 5,099 6,000 companies 2016-2021 growth 38% (6.7% p.a.) 5,000 4,816 4,323 Company count 4,134 2011-2016 growth 4,003 4,000 51% (9.1% p.a.) 3,687 3,286 2006-2011 growth 46% (7.9% p.a.) 2,984 3,000 2,705 2,745 2001-2006 growth 2,387 36% (4% p.a.) 2,207 2
Slide 43: Share of pipeline contributed by top companies
Share of pipeline contributed by top 10 companies, top 25 companies and companies with just 1 or 2 two drugs, 2011-2021 Top 10 Top 25 Cos with 1 or 2 drugs 25 23 21 19.61 19.6 19.74 19.26 19.38 19.36 18.32 18.96 18.7 % of total pipeline 19 18.33 18.33 17 16.48 17.9 17.93 15.72 14.77 14.89 15 13.38 1
Slide 44: Distribution of R&D companies by HQ country/region, 2021
Distribution of R&D companies by HQ country/region, 2021 Germany 2% France 3% C & S America/Africa 1% Japan 3% Canada 4% UK 5% China 9% USA 46% Rest of Asia Pacific 13% Rest of Europe 14% Source: Pharmaprojects® | Informa, 2021 44
Slide 45: Global drug development by category, 2021
Global drug development by category, 2021 Biological versus non-biological drugs as a % of pipeline 100% 90% 80% Non- 70% Biotech 60% 50% 40% Biotech 30% 20% 10% 0% 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Slide 46: R&D pipeline by therapy group, 2020 and 2021
R&D pipeline by therapy group, 2020 and 2021 8000 6961 6817 7000 6000 Drug Count 5000 4000 3063 3000 2742 2599 2092 1831 2000 1128 1034 1020 1012 938 1000 717 668 233 100 0 2020 2021 Source: Pharmaprojects® | Informa, 2021 46
Slide 47: Nanoform new mid-term business targets 2025
Nanoform new mid-term business targets 2025 35 lines >70 new APIs of which 200-250 7-14 are employees per year GMP compliant Up 0-25% +40% vs previous target vs previous target +40% (~200) (>50) vs previous target (25; 5-10 GMP) >90% Cash flow gross positive margin Unchanged Unchanged API = Active P
Slide 48: Q&A
Nanoform – 12-month rapid progress Nanoform – 12-month rapid progress Q&A Questions through: 1) Dial-in: FIN: +358981710520 SE: +46850558358 UK: +443333009269 US: +1 6319131422 PIN: 12138908# 2) Type in the question in the question box below 3) E-mail to IR@nanoform.com
Slide 49: Closing remarks
Nanoform – 12-month rapid progress Nanoform – 12-month rapid progress Prof. Edward Hæggström CEO Closing remarks
Slide 50: Thank you!
Thank you! Nanoform Capital Markets Day June 4th, 2021