Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — Q1 2022 Earnings Presentation
53 slides from Nanoform Finland Oyj's earnings presentation, May 24, 2022
Slide 1: Nanoform Management Presentation
Nanoform Management Presentation 1Q 2022 online presentation and conference call May 24th, 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 phases of
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 ➢ CESS® technology for small drug particle engineering molecules (chemical Nasdaq First North Premier Growth Market in Helsinki API compounds) discovered in and Stock
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: 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 7: 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 8: 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 >19 000 >58 000 >5 800 drugs in failed drugs in existing
Slide 9: 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 10: 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 11: Small molecules - Small is powerful
Small molecules - Small is powerful® 11
Slide 12: 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 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
CEO review 14
Slide 15: Selected Company Milestones 2020-2022 YTD
Selected Company Milestones 2020-2022 YTD FIRST EVER ALL NEAR-TERM 5 NEW GMP NASDAQ NANOFORMED LAUNCH OF TARGETS 2020 CERTIFICATION IPO DOSING BIOLOGICS CLIENTS/ SET AT IPO PARTNERSHIPS IN HUMANS ACHIEVED LoI RAISED STRONG SIGNED MID-TERM 13 NEW 2 GMP NANOFORMING STARMAP® v2 FOR NANOFORMED 2021 CLIN
Slide 16: Scaling for supercritical CO2 success!
Scaling for “supercritical CO2” success! Upscaling by 1000x, installation of Nanoform ‘super tank’, more than 40,000 liters of liquid CO2 vs earlier 40 liter bottles April 2022 Nanoform Headquarters & GMP Manufacturing Site Helsinki Finland 16
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 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: Global drug R&D pipeline size and growth
Global drug R&D pipeline size and growth 20,109 drugs 20,000 18,582 2016-2022 growth 47% (6.6% p.a.) 17,737 17,500 16,181 15,267 Drug count 14,872 15,000 2011-2016 growth 13,713 41% (7.1% p.a.) 12,300 12,500 2006-2011 growth 11,307 31% (5.6% p.a.) 10,479 10,452 10,000 9,605 9,737 9,713 2001-2006 gro
Slide 21: Global number of companies with active pipelines
Global number of companies with active pipelines 5,416 6,000 companies 5,099 2016-2022 growth 5,000 47% (6.6% p.a.) 4,816 Company count 4,323 4,134 4,003 4,000 2011-2016 growth 3,687 51% (9.1% p.a.) 3,286 2,984 3,000 2006-2011 growth 2,705 2,745 46% (7.9% p.a.) 2,387 2001-2006 growth 2,207 36% (4% p
Slide 22: Q1 2022 Record Quarter with New Projects and New Customers
Q1 2022 Record Quarter with New Projects and New Customers 8 WITH NEW SIGNED CUSTOMER 7 CUSTOMERS PROJECTS (4 new and 3 repeat) During 1Q 2022 eight new non-GMP projects were signed, with seven different customers, of which four were new customers, the majority of them US based. 22
Slide 23: Commercial Relationships 4Q19-1Q22
Commercial Relationships 4Q19-1Q22 7 major pharma companies e.g. Astra Zeneca and Boehringer Ingelheim 16 mid-sized, specialty pharma & biotech companies e.g. Herantis and TargTex 1 co-development including 4 new in Q1/2022 3 collaborations e.g. Aprecia and Celanese Corp 23
Slide 24: January-June 2022 events
January-June 2022 events Online events Crystal Engineering February Research Conference Maine New York London Connecticut London June March April April May March San Diego Basel Basel San Diego May June June April Israel Anaheim May May Florida Philadelphia Rotterdam Berlin May May March June Our ex
Slide 25: July-December 2022 events
July-December 2022 events New Jersey Boston Boston Belfast Glasgow Edinburgh Malmö New Jersey September October October September September December September September Manchester November San Diego September London November Florida Frankfurt Leipzig November November October Our experienced global
Slide 26: STARMAP and STARMAP Online
STARMAP® and STARMAP® Online - from standalone solution to secure, high-throughput desktop access Online 2020 2021 2022 2025 Access: By Nanoform on behalf of client Secure, direct analysis by client Molecule visibility: Visible to Nanoform under CDA Not shared with Nanoform Throughput/week: 10 1,000
Slide 27: 15,000 molecules Starmapped
15,000 molecules Starmapped ✓ 15,000 molecules already Starmapped ✓ Surprisingly evenly distributed, some positive scew towards positive propensity to crystallize ✓ Only 2% of the molecules in 1*1 (very low solubility and very low propensity to crystallize) while a mere 13% in 1- 2*1-2 (low solubili
Slide 28: 1Q 2022 Financials
1Q 2022 Financials 28
Slide 29: 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% ➢ Attrition between 90% 88% previous and current phase 80% 78% 74% ➢ Price per phase p
Slide 30: 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 - ➢ API for clinical trials are ➢ Drug
Slide 31: Nr of employees & nr of lines – on track towards 2025 targets
Nr of employees & nr of lines – on track towards 2025 targets Nr of employees Nr of lines 140 130 16 125 1 116 1 120 14 106 1 1 100 12 87 1 80 74 10 68 1 55 8 60 50 1 1 15 14 13 6 12 40 11 19 4 8 20 13 13 7 7 7 10 9 6 5 6 5 2 0 3Q21 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 4Q21 1Q22 0 3Q20 2Q21 1Q20 2Q20 4Q20
Slide 32: Nr of projects signed - on track towards 2025 targets
Nr of projects signed - on track towards 2025 targets Nr of projects signed in quarter Nr of projects signed - rolling 12 months 8 20 2 18 7 2 16 6 14 5 12 10 4 8 18 17 8 16 3 6 6 2 13 6 12 10 9 2 4 4 7 3 6 2 1 2 2 2 1 0 1Q21 1Q20 2Q20 3Q20 4Q20 2Q21 3Q21 4Q21 1Q22 0 4Q20 1Q20 2Q20 3Q20 1Q21 2Q21 3Q
Slide 33: Nr of cumulative projects signed
Nr of cumulative projects signed Cumulative nr of projects signed Cumulative nr of projects signed 40 ≥48+5=53 2 35 30 36+2=38 2 25 28+2=30 20 36 6x 15 26 28 18 10 20 12 18 12 6 5 9 6 7 0 4Q21 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 1Q22 1Q20 1Q21 1Q22 2020 2021 2022 target GMP projects, cumulative GMP p
Slide 34: Rolling 12 months and quarterly revenue
Rolling 12 months and quarterly revenue (EURm) Quarterly revenue (EURm) Revenue - rolling 12 months 0.80 2.50 2.44 0.76 0.70 0.66 2.00 1.95 0.60 0.55 5x 12x 0.50 0.48 1.49 1.50 0.40 1.17 0.28 1.00 0.30 0.82 0.69 0.19 0.19 0.20 0.55 0.15 0.16 0.50 0.39 0.10 0.20 0.00 0.00 1Q21 1Q20 2Q20 3Q20 4Q20 1Q2
Slide 35: First quarter revenue and nr of projects contributing
First quarter revenue and nr of projects contributing (EURm) First quarter revenue and y/y growth Nr of projects contributing to revenue 0.90 25 22+1=23 +173% 20 0.60 14 15 10 0.30 +85% 6 5 0 1Q20 1Q21 1Q22 0.00 1Q20 1Q21 1Q22 Non-GMP projects GMP projects 35
Slide 36: Gross margin above 2025 target, EBITDA to turn as revenue grows
Gross margin above 2025 target, EBITDA to turn as revenue grows Revenue, gross profit & margin - rolling 12 months (EURm) Quarterly EBITDA and operating costs (EURm) 0.0 3.0 100% 92% 92% -1.0 89% 85% 90% 2.5 78% 80% -2.0 72% 2.0 70% -3.0 60% 1.5 50% -4.0 40% 1.0 40% -5.0 21% 0.5 30% 20% -6.0 3Q21 1Q
Slide 37: KPI's
KPI’s Financial KPIs Operational KPIs EUR thousand 01-03/2022 01-03/2021 1-12/2021 1-12/2020 1-12/2019 EUR thousand 1-3/2022 1-3/2021 1-12/2021 1-12/2020 1-12/2019 Revenue 760 278 1,955 687 49 Number of new projects started during the period Revenue growth % 174% 85% 185% n.m. n.m. Non-GMP 8 6 16 10
Slide 38: Income statement
Income statement Consolidated statement of comprehensive income 1-3/2022 comments 1-3/2022 1-3/2021 1-12/2021 1-12/2020 1-12/2019 ➢Revenue grew by 174% to EUR 0.76 million in 1Q22, stemming from EUR thousand 23 different customer projects (14 projects in 1Q21). Revenues are Revenue 760 278 1,955 687
Slide 39: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders1 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ 39
Slide 40: Q&A
Q&A www.nanoform.com San Diego - Chicago - New York - Lisbon - Newcastle - Oxford - Cambridge - Bordeaux - Stockholm - Helsinki 40
Slide 41: Appendix
Appendix 41
Slide 42: Nanoform educational material
Nanoform educational material VIDEO - CPhI Discover 2021 presentation: “Overcoming Drug Development Challenges with Nanotechnology” - Nanoform CCO Christian Jones, FRSC, Nanoform Science & Technology Team Leader Elisabetta Micelotta, experts from Johnson Matthey and Quotient Sciences shared insights
Slide 43: International team of highly skilled professionals
International team of highly skilled professionals Personnel split by main functions 2% R&D and non-GMP projects 2% Currently Quality Control 2% 130 26 5% GMP Manufacturing employees Nationalities and 5% Quality Assurance growing 32% 6% Sales & Marketing Project Management 6% Finance Balanced 39 PhD
Slide 44: 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 45: 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 46: 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 47: 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 48: Commercial Relationships 2019-2021
Commercial Relationships 2019-2021 Client signed 2019 Nanoform targets to achieve scale in APIs Tier 2 – Mid-sized Global large pharma Client signed 2020 and specialty 1 UK respiratory pharma and biotech Client signed 2021 biotech UK ✓ Financially stable organizations biotech West ✓ Broad pipeline o
Slide 49: 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 50: Nanoform Dynamic Factors
Nanoform 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 & co
Slide 51: How small is nanometer (nm)?
How small is nanometer (nm)? 1 nm = 10-9 m 51
Slide 52: Nanoforming - platform enabler across drug delivery
Nanoforming - platform enabler across drug delivery Co-Polymer Oral Tablet Oral Buccal Respiratory Nasal Ophthalmic Drug Delivery 52
Slide 53: 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 Aug 25, 2022 – Interim report January-June 2022 Nov 29, 2022 – Interim report January-September 2022