Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — FY2021 Earnings Presentation
52 slides from Nanoform Finland Oyj's earnings presentation, Feb 22, 2022
Slide 1: Nanoform Management Presentation
Nanoform Management Presentation 4Q/FY2021 online presentation and conference call February 22nd, 2022 – 15.00 Helsinki time Our proprietary nanoforming technologies and services span the full range of drug development from small-molecule nanoparticles to large-molecule biologics. We support all pha
Slide 2: Disclaimer
Disclaimer Forward-Looking Statements This press release 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,” “es
Slide 3: Introduction to Nanoform
Introduction to Nanoform 3
Slide 4: Nanoform in a Snapshot
Nanoform in a Snapshot Nanoform Platform Technology The Share ➢ Global experts in Bulk nanotechnology and ➢ CESS® technology for small ➢ Listed June 4th, 2020, on drug particle engineering molecules (chemical Nasdaq First North Premier API compounds) discovered in Growth Market in Helsinki 2012 and
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 2010-2021 Global pharmaceutical R&D spending 2010-2026E (USDbn) Chemical Biologics 248 254 250 237
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: 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 >18 000 >58 000 >5 800 drugs in failed drugs in existing
Slide 8: 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 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: Nanoforming - platform enabler across drug delivery
Nanoforming - platform enabler across drug delivery Co-Polymer Oral Tablet Oral Buccal Respiratory Nasal Ophthalmic Drug Delivery 11
Slide 12: 1 Million evaluations per week
1 Million evaluations per week ➢ Enables in silico experiments in large quantities, creating fast predictions of which molecules should be nanoformed 1,000 evaluations ➢ Helps pharma partners pick suitable per week drug candidates for further Starmap2.0 development from their large libraries launche
Slide 13: CEO review
CEO review 13
Slide 14: 24-month rapid growth success
24-month rapid growth success 12/2019 12/2020 12/2021 Growth Employees 43 74 125 ~3x Nationalities 9 15 25 ~3x PhD's 18 25 38 ~2x Manufacturing lines 4 9 15 ~4x Cumulative nr of projects started 2 12 30 ~15x 14
Slide 15: 3 steps towards helping patients
3 steps towards helping patients "PoC engine" ✓4Q19: first 2 PoC projects signed ✓4Q21: cumulatively > 2 dozen PoCs started ✓Next: get to > 200 PoCs done “GMP engine” ✓4Q21: first 2 GMP projects signed ✓Next: cumulatively get > 2 dozen GMP projects done Products on the market helping patients ✓Work
Slide 16: 2021 review & focus forward
2021 review & focus forward Focus areas 2022 2021 another strong year ✓Continued accelerating order intake ✓Successful clinical study ✓GMP engine ✓First GMP projects won ✓Productivity, economics of scale, and automation ✓Gross margin exceeds 2025 target ✓Keeping sight on mid- & long-term goals ✓All
Slide 17: Nanoform near-term business targets 2022
Nanoform near-term business targets 2022 Topic Target Status GMP Line Capacity “2 new GMP lines in 2022” On track Biologics pilot-GMP “Biologics pilot line for GMP in 2022” On track “At least 20 new customer non-GMP Non-GMP Projects projects in 2022” On track “At least 3 new customer GMP GMP Project
Slide 18: Nanoform mid-term business targets 2025
Nanoform mid-term business targets 2025 - New raised targets announced on June 2nd, 2021 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 18 GMP = Good Manufacturing Practice
Slide 19: Commercial
Commercial 19
Slide 20: 24-month global commercial team expansion
24-month global commercial team expansion 20
Slide 21: Expanding global commercial team
Expanding 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 Jone
Slide 22: 24-month global commercial relationships development
24-month global commercial relationships development 2019 2020 2021 22
Slide 23: Commercial Relationships
Commercial Relationships Client announced 2019 Nanoform targets to achieve scale in APIs Tier 2 – Mid-sized Global large pharma Client announced 2020 and specialty 1 UK respiratory pharma and biotech Client announced 2021 biotech UK ✓ Financially stable organizations biotech West ✓ Broad pipeline of
Slide 24: Financials
Financials 24
Slide 25: Personnel and nr of lines - on track towards 2025 targets
Personnel and nr of lines - on track towards 2025 targets
Slide 26: Nr of projects - on track towards 2025 indicative targets
Nr of projects - on track towards 2025 indicative targets Ratio of GMP to non-GMP in the 2025 indicative target is roughly based on the industry probabilities for moving forward in the development pipeline. Official target for Nanoform is > 70 new APIs annually by 2025
Slide 27: Cumulative number = most important for getting products on the market
Cumulative number = most important for getting products on the market Ratio of GMP to non-GMP in the 2025 indicative target is roughly based on the industry probabilities for moving forward in the development pipeline. Official target for Nanoform is > 70 new APIs annually by 2025
Slide 28: Broad competence has boosted gross margin
Broad compentence has boosted gross margin - 2025 gross margin target reached
Slide 29: Economics of scale emerging in other operating cost per employee
Economics of scale emerging in other operating cost per employee Big productivity improvement expected from #projects/line/year
Slide 30: Materials cost down, other costs flat despite increase in employees
Materials cost down, other costs flat despite 70% increase in nr of employees in 2021 => flat EBITDA
Slide 31: Strong momentum in nr of projects, revenue growth, and orders received
Strong momentum in nr of projects, revenue growth, and orders received *Part of orders received may not turn into revenue as clients have the right to change or cancel orders
Slide 32: Orders received > EUR 5m in 2021, up 5x vs 2020
Orders received* > EUR 5m in 2021, up 5x vs 2020. 4Q21 orders, up 5x vs 4Q20, exceeded full year 2021 revenue. *Part of orders received may not turn into revenue as clients have the right to change or cancel orders
Slide 33: KPI's
KPI’s Financial KPI’s Operational KPI’s EUR thousand 10-12/2021 10-12/2020 1-12/2021 1-12/2020 1-12/2019 EUR thousand 10-12/2021 10-12/2020 1-12/2021 1-12/2020 1-12/2019 Revenue 655 186 1,955 687 49 Number of new projects started during the period Revenue growth % 252% 279% 185% n.m. n.m. Non-GMP 2
Slide 34: Income statement
Income statement Consolidated statement of comprehensive income 1-12/2021 comments EUR thousand 10-12/2021 10-12/2020 1-12/2021 1-12/2020 1-12/2019 ➢Revenue stemmed from 22 different customer projects in 2021 (12 projects in Revenue 655 186 1,955 687 49 2020). Revenues are recognized over the lifeti
Slide 35: Q&A
Q&A www.nanoform.com San Diego - Chicago - New York - Lisbon - Oxford - Cambridge – Bordeaux - Stockholm - Helsinki 35
Slide 36: Appendix
Appendix 36
Slide 37: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders1 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ 37
Slide 38: International team of highly skilled professionals
International team of highly skilled professionals Personnel split by main functions R&D and non-GMP operations 1% Quality Control 2… Currently 125 25 3% GMP Manufacturing employees 5% Nationalities 6% and Quality Assurance growing 33% Project Management 6% Finance 6% Administration 38 PhD’s Balance
Slide 39: 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 40: Revenue drivers and industry attrition rates
Revenue drivers and 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% 88% > Attrition between previous 90% and current phase 78% 80% > Price per phase per A
Slide 41: Nanoform - Attractive revenue model
Nanoform - Attractive revenue model 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 of the ➢ API for clinical
Slide 42: Dynamic factors
Dynamic factors ✓ Pricing power increases as brand recognition becomes stronger and we show performance ✓ Productivity (nr of projects per line per year) improves as we do more projects ✓ Success ratio (PoC=>PoP=>GMP) goes up as we learn more about the process and different APIs ✓ Time & costs per p
Slide 43: Small molecules - Patented technology
Small molecules - Patented 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 and the API are rel
Slide 44: 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 45: Global pharma market projected to reach USD 1.8tn by 2026
Global pharma market projected to reach USD 1.8tn by 2026 Covid net impact 2020-2026E: +$134B Global medicine spending 2010-2026E (USDtn) (Covid vaccines and therapeutics +$309B and disruptions in other segments -$175B) 2.0 $1.8tn 1.8 1.6 1.4 1.2 $0.9tn 1.0 0.8 0.6 0.4 0.2 0.0 2010 2011 2012 2013 20
Slide 46: 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 47: 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 48: Global clinical drug development phase trends
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 48
Slide 49: 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 50: 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 51: Achieved near-term business targets
Achieved near-term business targets Topic Target Status GMP Approval “GMP approval expected no later than Q3 2020” Achieved - GMP certificate awarded April 2020 ✓ Ongoing Client Intake “For 2020, our ambition is to accelerate our growth by winning more new customers than in 2019” Achieved – 4 new cu
Slide 52: Further enquiries
FURTHER ENQUIRIES CFO Albert Hæggström albert.haeggstrom@nanoform.com +358 29 370 0150 Director of Investor Relations Henri von Haartman hvh@nanoform.com +46 7686 650 11 FINANCIAL CALENDAR April 12, 2022 – Annual General Meeting May 24, 2022 – Interim report January-March 2022