Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — FY2022 Earnings Presentation
58 slides from Nanoform Finland Oyj's earnings presentation, Feb 28, 2023
Slide 1: Nanoform Management Presentation Q4 and FY 2022 report
Nanoform Management Presentation Q4 and FY 2022 report February 28th, 2023 Our proprietary nanoforming technologies and services span the full range of drug development from small-molecule nanoparticles to large-molecule biologics. We support all phases of drug development, accelerating time to clin
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
Short introduction to Nanoform 3
Slide 4: Nanoform in a Snapshot
Nanoform in a Snapshot The Share Nanoform Platform Technology ➢ Listed June 4th, 2020, on ➢ Global experts in Bulk nanotechnology and drug particle engineering ➢ CESS® technology for small Nasdaq First North Premier Growth Market in Helsinki API molecules and Stockholm ➢ ~150 employees, ~30 national
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 300 278 285 60
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 - Patented technology
Small molecules - Patented technology Green technology Controlled Expansion of Supercritical Solutions - CESS® > Supercritical CO2 is guided into a pressure 1 vessel loaded with API 1 4 2 > Increasing the pressure and temperature in the 2 vessel dissolves the API in supercritical CO 2 5 > The CO2 an
Slide 9: Small molecules - Small is powerful
Small molecules - Small is powerful® 9
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 - Technology
Large molecules - Technology Green Exhaust technology Nanoforming process for biologics 1 API containing feed solution is pumped into nebulizer Nanoparticle 5 collection Ionization 2 Feed solution is nebulized into mist droplets and mixed with the carrier gas Solvent evaporation & 4 nanoparticle 3 M
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 existing new drugs a second chance drugs > 20 000 > 58 000 > 5 800 drugs in failed drugs in exist
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 ➢ Mid-sized and specialty pharma API ➢ Royalty as a %
Slide 14: CEO review and business targets
CEO review and business targets 14
Slide 15: António da Silva, Chief of Business Operations
António da Silva, Chief of Business Operations ➢ CBO, member of the management team as of Jan 1 , 2023 ➢ Extensive background in the CDMO and particle engineering space with +23 years' experience, having worked for ~20 years at Hovione where he took part in several pharmaceutical product launches ➢
Slide 16: Critical mass reached through a series of investments
Critical mass reached through a series of investments During 2020-2022 we built/implemented: ✓ 10 non-GMP CESS lines and 4 non-GMP Biologics lines including a pilot line for GMP ✓ 3 clean-rooms with 3 new GMP CESS lines, of which 2 high potent ✓ 40 m3 CO2 tank system covering all CESS lines ✓ QC lab
Slide 17: One of our three state-of-the-art GMP nanoforming suites in Helsinki
One of our three state-of-the-art GMP nanoforming suites in Helsinki, Finland Page 15 17
Slide 18: Nanoform near-term business targets 2022
Nanoform near-term business targets 2022 Topic Target Status GMP2 achieved in 2022, GMP Line Capacity “2 new GMP lines in 2022” GMP3 ready during Q2/2023 Biologics pilot-GMP “Biologics pilot line for GMP in 2022” Achieved in 2022 “At least 20 new customer non-GMP Non-GMP Projects projects in 2022” 1
Slide 19: Nanoform near-term business targets 2023
Nanoform near-term business targets 2023 Topic Target Status “ Increased number of non-GMP Customer New target and GMP projects signed Projects in 2023 vs 2022 ” * “ Improved operating Operating free cashflow New target Free Cashflow in 2023 vs 2022 ” ** GMP = Good Manufacturing Practice * 17 non-GM
Slide 20: Nanoform mid-term business targets 2025
Nanoform mid-term business targets 2025 35 lines >70 of which new APIs 200-250 7-14 are employees per year GMP compliant >90% Cash flow gross positive margin API = Active Pharmaceutical Ingredient 20 GMP = Good Manufacturing Practice
Slide 21: Commercial
Commercial 21
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: 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 NME Biologic Non-NME 1) Non-GMP GMP 100% 90% ➢ Attrition between 90% 88% previous and current phase 80% 78% 74% ➢ Price per phase per
Slide 25: 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 - ➢ API for c
Slide 26: Global commercial team
Cambridge Helsinki Chicago Chief Commercial Officer Commercial Associate Vice President Christian Jones Britta Madison Helsinki Business Development Commercial Associate Sergie Letser Leonor da Silva Oxford Commercial Insights Officer Dr. Jamie Unwin San Diego Durham Vice President Vice President Bu
Slide 27: Commercial highlights 2022
Commercial highlights 2022 ➢ AstraZeneca Plc – positive technology assessment concluded ➢ Blockbuster collaboration – commercial terms signed, project in GMP manufacture and planned to go into clinic in 2023 ➢ Targtex – positive in vivo data for Glioblastoma Multiforme, project going into GMP manufa
Slide 28: Number of projects – target to sign more projects in 2023 vs 2022
Number of projects – target to sign more projects in 2023 vs 2022 28
Slide 29: Activity level increased in 4Q22, impact should be seen in 2023
Activity level increased in 4Q22, impact should be seen in 2023 29
Slide 30: Days from Lead to Contract Execution
Days from Lead to Contract Execution 600 2019:310 529 500 444 415 400 380 2020:161 Days 320 324 300 300 2021:144 2022:146 277 241 207 197 197 200 186 186 175 154 138 125 126 110 111 114 117 89 96 100 72 74 76 60 54 62 55 63 55 48 42 50 46 47 34 33 31 0
Slide 31: Commercial Relationships Q4/2019-Q4/2022
Commercial Relationships Q4/2019-Q4/2022 7 major pharma companies e.g. Astra Zeneca and Boehringer Ingelheim 24 mid-sized, specialty pharma & biotech companies e.g. Pharmanovia, Herantis and TargTex 1 co-development 3 collaborations e.g. Aprecia and Celanese Corp ➢ 12 new clients in 2022, 2 new in Q
Slide 32: Small is Green
Small is Green ➢ Our CESS® and Bio processes are free of organic solvents (additives) ➢ CESS® utilizes clinical grade recycled CO2, produced as a side product from road salt production ➢ We operate STARMAP®, the digital twin (in-silico) of our CESS® process, to eliminate unwanted experiments and to
Slide 33: 4Q22 and FY22 Financials
4Q22 and FY22 Financials 33
Slide 34: Focus in 2023 is on productivity, efficiency, automation, and cashflow
After 3 years of adding personnel, systems and lines, focus in 2023 is on productivity, efficiency, automation, and cashflow ”We do not expect to add to our headcount (and costs in ”Capex will be lower in 2023, as we focus on productivity general) in 2023 as we focus on productivity, efficiency, and
Slide 35: Number of projects signed
Number of projects signed Nr of projects, annually & cumulatively Nr of non-GMP projects signed 25 50 - 1 40 20 7 i, 3 77 30 6 w 2 . wa 10 7 ? 8 15 6 6 6 5 20 4 3 a of a 5 i) 2 | 2 | 2 | 24) 2 10 0 bow t : : oo 10 16 wy 12 coc fo fS tH +t +t HN NN AN 0 = ggsgsggsgggseggssg 2019 2020 2021 2022 =>2020
Slide 36: Number of projects generating revenue
Number 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). 36
Slide 37: Rolling 12 month and quarterly revenue
Rolling 12 month and quarterly revenue 37
Slide 38: Ramp-up of GMP impacted materials & services costs
Ramp-up of GMP impacted materials & services costs 38
Slide 39: GMP ramp-up impacted the gross margin in 4Q22
GMP ramp-up impacted the gross margin in 4Q22 39
Slide 40: IT costs have peaked after a successful SAP implementation
IT costs have peaked after a succesful SAP implementation 40
Slide 41: Scale & automation to enable productivity & cost synergies
Scale & automation to enable productivity & cost synergies 41
Slide 42: We expect an improved operating free cash flow in 2023 vs 2022
We expect an improved operating free cash flow in 2023 vs 2022 as focus shifts from adding new capacity to getting more out of the existing one Operating free cashflow (EURm) 0 ➢ 2023 should see flattish costs and lower capex, helping to improve the cashflow -18.2 -17.7 -19.0 ➢ Our balance sheet is
Slide 43: Financial KPI's
Financial KPI's EUR thousand Operating loss -19,705 Loss for the period -19,690 0.29 sin pr plant, and equipment e free ca and cash valents (end of period)
Slide 44: Income statement
Income statement 1-12/2022 comments: ➢ Revenue grew by 78% to EUR 3.5 million in 2022, stemming from 35 different customer projects (2.0 million from 22 projects in 2021). The share of revenues from GMP related projects was slightly more than ten per cent of the revenue recognized in 2022. Revenues
Slide 45: Operational KPI's
Operational KPI's 10-12 10-12/ 1-12/ 1-12/ 1-12/ 1-12/ 2022 2021 2022 2021 2020 2019 w customer projects signed during 2 2 17 16 rT 2 GMP 1 2 Total number of new customer projects 3 4 18 18 10 2 Number of lines (end of the period) Non-GMP 18 14 18 14 8 4 GMP 1 1 1 1 Total number of lines (end of per
Slide 46: Q&A
Q&A www.nanoform.com San Diego - Chicago - New York - Lisbon - Newcastle - Oxford – London - Cambridge - Bordeaux - Stockholm - Helsinki 46
Slide 47: Financial Calendar
FINANCIAL CALENDAR • February 28, 2023 – Presentation at Kepler Cheuvreux 10.00-11.00 EET (digital) • February 28, 2023 – Financial Hearings webcast presentation 15.00-16.00 EET • March 1, 2023 – Presentation at SEB, Helsinki (in person) • March 13, 2023 – Presentation at Danske Bank Small & Mid Cap
Slide 48: Appendix
Appendix 48
Slide 49: Nanoform educational material
Nanoform educational material VIDEOS PODD 2022 Video: “How drug delivery is enabling a clinical trial for Glioblastoma” – TargTex CEO Dr João Seixas and Nanoform CCO Christian Jones presenting promising data enabled by a nanoformed drug product for the treatment of glioblastoma multiforme (GBM): ht
Slide 50: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders1 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ 50
Slide 51: How small is a nanometer (nm)?
How small is a nanometer (nm)? 1 nm = 10-9 m 51
Slide 52: Nanoform from June 2020 IPO to December 2022
Nanoform from June 2020 IPO to December 2022 IPO June 2020 December 2022 Growth Employees 50 150 ~3x Nationalities 9 30 ~3x PhD's 18 35 ~2x Manufacturing lines 5 18 ~3x Commercial team 2 11 ~5x Customers enrolled 5 35 ~7x Customer projects started 5 47 ~10x 52
Slide 53: Nanoform commercial team events 2022
Nanoform commercial team events 2022 30 events & >700 meetings Rotterdam London London Israel NYC Connecticut San Diego March April May May March April April Anaheim Philadelphia Florida Basel Basel Berlin Malmo May May May May June June September Crystal Engineering Research Conference Glasgow Belf
Slide 54: Tumour Eradication in Rodents from a Nanoformed Glioblastoma drug
Tumour Eradication in Rodents from a Nanoformed Glioblastoma drug • In-vivo study (rodents) conducted by customer TargTex. • The nanoformed drug product provided a controlled release and deep drug diffusion across the brain parenchyma. • Results were presented October 2022 at PODD in Boston: 1) Long
Slide 55: New collaboration agreement - for a blockbuster drug
New collaboration agreement - for a blockbuster drug • Nov 2021 - Agreement to manufacture nanoformed GMP material on an existing blockbuster drug for a European headquartered international company. • Nov 2022 - Following 12 months of preclinical development work, 2 privately held European pharmaceu
Slide 56: Small molecules - CESS Superior to Existing Technologies
Small molecules - CESS® Superior to Existing Technologies CESS® comparison with existing technologies Controlled Expansion of Solid dispersion Supercritical Solutions Jet milling Nanomilling (e.g. spray drying) (CESS®) Extracts API from supercritical CO2 API is dispersed into a solid Application of
Slide 57: 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. (Econ.) Edward Hæggström Albert Hæggström • Professor at the University of Helsinki, Head of Electronics Research Lab. • 20 years of finance and investing e
Slide 58: 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