Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — H1 2022 Earnings Presentation
54 slides from Nanoform Finland Oyj's earnings presentation, Aug 25, 2022
Slide 1: Nanoform Management Presentation
Nanoform Management Presentation Q2 and H1 2022 online presentation and conference call August 25th, 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
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 2022 YTD
Selected Company Milestones 2022 YTD 2022 US GMP MANUFACTURING STARMAP® ONLINE UPSCALING CO2 INPUT TO GMP MANUFACTURING ANNOUNCEMENT LAUNCH YTD BY 1000X NEW HALF YEAR RECORD: ASTRAZENECA PLC 13 NEW PROJECTS CONCLUDES WITH 12 CLIENTS NANOFORM PARTNERS TECHNOLOGY EVALUATION AND WITH PHARMANOVIA WITH P
Slide 16: Isolator to GMP-2 manufacturing line arrived August 9th, 2022
Isolator to GMP-2 manufacturing line arrived August 9th, 2022 Nanoform Quality Director Johanna Kause and Engineering Project Coordinator Kari Steffen supervising isolator delivery An isolator allows the containment of the pharmaceutical process, a protected environment, free of viable microorganism
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: Experienced global sales team
Cambridge Chicago Chief Commercial Officer Helsinki Vice President Christian Jones Commercial Associate Business Development Britta Madison Sergie Letser Oxford Commercial Insights Officer Dr. Jamie Unwin Durham Vice President San Diego Business Development Vice President Dr. Nathalie Huther Busines
Slide 23: Good momentum with customers and projects
Good momentum with customers and projects H1/2022 H1/2021 H1/2020 23
Slide 24: Commercial Relationships Q4/2019-Q2/2022
Commercial Relationships Q4/2019-Q2/2022 7 major pharma companies e.g. Astra Zeneca and Boehringer Ingelheim 21 mid-sized, specialty pharma & biotech companies e.g. Pharmanovia, Herantis and TargTex 1 co-development including 5 new in Q2/2022 3 collaborations e.g. Aprecia and Celanese Corp 24
Slide 25: Successful technology evaluation by AstraZeneca Plc
Successful technology evaluation by AstraZeneca Plc In Q2 2022 AstraZeneca Plc concluded its thorough technology evaluation of Nanoform’s proprietary CESS® Technology. The outcome of the technology evaluation was positive, and AstraZeneca is now moving forward to an identification and implementation
Slide 26: Nanoform partners with Pharmanovia
Nanoform partners with Pharmanovia Press release Nanoform Finland Plc July 14th, 2022 Nanoform and Pharmanovia to breathe new life into iconic medicines Helsinki, Finland – Nanoform Finland Plc., an innovative nanoparticle medicine-enabling company, today announced that it has partnered with Pharman
Slide 27: 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 28: 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 29: 2Q 2022 Financials
1Q 2022 Financials 29
Slide 30: Nr of employees & nr of lines ~3x during last 2.5 years
Nr of employees & nr of lines ~ 3x during last 2.5 years Nr of employees Nr of lines 160 18 143 130 16 1 140 125 1 116 14 1 120 106 1 12 1 100 87 1 80 74 10 68 55 8 1 16 60 50 1 1 15 13 14 40 6 12 11 19 20 13 13 10 9 13 4 8 7 5 6 5 6 7 7 0 2 3Q20 1Q20 2Q20 4Q20 1Q21 2Q21 3Q21 4Q21 1Q22 2Q22 0 1Q20 2
Slide 31: Nr of projects signed in 2Q, 1H and cumulatively
Nr of projects signed in 2Q, 1H and cumulatively Nr of projects signed Cumulative nr of projects signed 13 48+5=53 41+2=43 8 28+2=30 5 20 5 12 7 2 1 1H21 2Q20 2Q21 2Q22 2020 2021 2022 1H20 1H22 2Q20 2Q21 2Q22 target GMP projects, cumulative Nr of non-GMP projects Non-GMP projects, cumulative
Slide 32: Nr of projects signed ~4x (r12m) and 7x (cumul.) during last 2.5 years
Nr of projects signed ~ 4x (r12m) and 7x (cumul.) during last 2.5 years Nr of projects signed - rolling 12 months Cumulative nr of projects signed 25 45 2 2 40 20 2 2 35 2 30 2 15 25 10 21 20 41 17 18 36 16 13 15 28 12 26 5 9 10 7 10 18 20 6 5 12 0 7 9 6 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 4Q21 1Q22
Slide 33: Nr of projects generating revenue ~5x (r12m)
Nr of projects generating revenue ~ 5x (r12m) and 2x (per line/year) during last 2.5 years Nr of projects generating revenue Nr of revenue generating projects per line - rolling 12 months - rolling 12 months 35 2.0 1.9 1.9 32 30 30 1.4 1.5 1.5 1.4 25 1.3 1.3 22 19 1.1 20 1.0 17 17 1.0 0.9 15 12 10 9
Slide 34: First half revenue and nr of projects contributing
First half revenue and nr of projects contributing (EURm) First half revenue Nr of projects contributing to revenue 2.00 30 27+1=28 1.65 25 1.50 20 16 15 1.00 0.82 10 7 0.50 5 0.34 0 1H20 1H21 1H22 0.00 1H20 1H21 1H22 Non-GMP projects GMP projects
Slide 35: Quarterly and rolling 12 months revenue
Quarterly (~6x) and rolling 12 months revenue (~14x) during last 2.5 years (EURm) Quarterly revenue (EURm) Revenue - rolling 12 months 1.00 3.00 2.78 0.89 0.90 2.44 0.76 2.50 0.80 0.70 0.66 1.95 2.00 0.60 0.55 0.48 1.49 0.50 1.50 1.17 0.40 0.28 1.00 0.82 0.30 0.69 0.19 0.20 0.15 0.16 0.19 0.55 0.50
Slide 36: Gross margin above 2025 target, EBITDA to turn as revenue grows faster than costs
Gross margin above 2025 target, EBITDA to turn as revenue grows faster than costs Revenue, gross profit & margin Quarterly EBITDA (EURm) (EURm) - rolling 12 months 0.00 3.0 92% 92% 92% 100% 89% -1.00 85% 2.5 78% 72% 80% -2.00 2.0 1.5 60% -3.00 40% 1.0 -4.00 40% 21% 0.5 -5.00 20% 0.0 -6.00 3Q21 1Q20
Slide 37: IT expenses risen as planned due to investment in new ERP system
IT expenses risen as planned due to investment in new ERP system (EURm) IT expenses - quarterly (EURm) IT expenses, rolling 12 months 0.00 0.00 -0.10 -0.06 -0.08 -0.08 -0.20 -0.09 -0.08 -0.23 -0.26 -0.20 -0.15 -0.15 -0.40 -0.31 -0.31 -0.33 -0.40 -0.60 -0.48 -0.30 -0.80 -0.40 -0.78 -0.39 -0.39 -1.00
Slide 38: Travel back after covid, but digital meetings can save time
Travel back after covid, but digital meetings can save time, energy & the environment (EURm) Travel expenses - quarterly Travel expenses - rolling 12 months (EURm) 0.00 0.00 -0.02 -0.01 -0.02 -0.02 -0.02 -0.05 -0.02 -0.07 -0.07 -0.04 -0.10 -0.10 -0.10 -0.04 -0.06 -0.05 -0.15 -0.13 -0.06 -0.15 -0.07
Slide 39: Operational KPI's
Operational KPI's Operational KPI's 4-6/2022 4-6/2021 1-6/2022 1-6/2021 1-12/2021 1-12/2020 1-12/2019 Number of new customer proje signed during the period Non-GMP = 2 13 8 16 10 2 GMP 2 Total number of new customer projects 5 2 13 8 18 10 2 Number of lines (end of the period) Non-GMP 16 12 16 12 14
Slide 40: Financial KPI's
Financial KPI’s Financial KPI's EUR thousand 4-6/2022 4-6/2021 1-6/2022 1-6/2021 1-12/2021 1-12/2020 1-12/2019 Revenue 890 546 1,650 824 1,955 687 49 Revenue growth % 63% 100% 141% 185% n.m n.m Gross profit 820 ae 761 1,792 497 -323 Gross margin 92% 95% 92% 92% 92% 72% neg EBITDA 5,484 4,358 10,057
Slide 41: Income statement
Income statement 1-6/2022 comments ➢Revenue grew by 100% to EUR 1.65 million in 1H22, stemming from 28 different customer projects (16 projects in 1H21). The impact from the two GMP contracts signed in 4Q21 was yet modest on the revenue recognized. Revenues are recognized over the lifetime of the pr
Slide 42: Q&A
Q&A www.nanoform.com San Diego - Chicago - New York - Lisbon - Newcastle - Oxford – London - Cambridge - Bordeaux - Stockholm - Helsinki 42
Slide 43: Appendix
Appendix 43
Slide 44: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders1 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ 44
Slide 45: Nanoform educational material
Nanoform educational material VIDEOS CPhI Discover 2021 presentation: “Overcoming Drug Development Challenges with Nanotechnology” – Nanoform, Johnson Matthey and Quotient Sciences experts shared insights into the power of sparse-data AI in drug development and the collaborative studies investigatin
Slide 46: International team of highly skilled professionals
International team of highly skilled professionals Personnel split by main functions R&D and non-GMP projects 1% 2% GMP Manufacturing 4% ~140 ~30 4% Quality Control employees 5% nationalities Quality Assurance 33% Sales & Marketing 6% Administration 6% Finance Balanced ~40 PhD’s Project Management c
Slide 47: 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 48: 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 49: STARMAP and STARMAP Online
STARMAP® and STARMAP® Online What do we do? Our STARMAP® Online platform leverages cutting-edge sparse-data AI to pick winners among candidate molecules that are predicted to be best amenable to CESS®-powered Nanoforming and that exhibit optimal production characteristics. How do we do this? When ex
Slide 50: 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 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: How small is a nanometer (nm)?
How small is a nanometer (nm)? 1 nm = 10-9 m 52
Slide 53: Nanoforming - platform enabler across drug delivery
Nanoforming - platform enabler across drug delivery Co-Polymer Oral Tablet Oral Buccal Respiratory Nasal Ophthalmic Drug Delivery 53
Slide 54: 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 Nov 29, 2022 - Interim report January-September 2022 Feb 28, 2023 - Annual Review 2022, Financial Statements fo