Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — Q1 2025 Earnings Presentation
51 slides from Nanoform Finland Oyj's earnings presentation, May 20, 2025
Slide 1: Nanoform Management Presentation Q1 2025
Nanoform Management Presentation Q1 2025 May 20th, 2025
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: Introduction and Key Business Highlights
Introduction Nanoform Breaker Slide & Option Key Business 2 Highlights CEO Edward Hæggström 3 Nanoform.com | @nanoform
Slide 4: Key strategy
Key strategy Nanoform work with In parallel, to show a All customers/partners to conservative industry the active pharmaceutical enable novel & existing power of nanoforming, we ingredients (API’s) molecules to become new create up to a dozen should be Starmapped (AI) and improved medicines ‘product
Slide 5: Nanoform Technology – route to market
Nanoform Technology – route to market Customers: 1. Global large pharma Originators Drugs to market 2. Mid-sized and specialty pharma 3. Biotech Development partners Commercial partners Product Targeted first Product Originator Originator Kernel drug on market Kernels or or R&D Supergeneric / High v
Slide 6: Proprietary technology platforms
Proprietary technology platforms Small Large Formulation AI molecules molecules Highly differentiated STARMAP® 2.0 online Proven CESS®* Unique novel formulations and picks best candidates nanotechnology enables BIO nanoparticles unique drug delivery and accelerates new medicines through enable impro
Slide 7: Nanoform key business highlights
Nanoform key business highlights I Full mosaic of many license and supply agreements emerge for our leading Product Kernels II Continued growth in new customers, new projects, revenue and other operating income Successfully manufacturing 100kg of nanoenzalutamide, next up is pivotal clincial studies
Slide 8: Nanoform.com | @nanoform
Nanoform.com | @nanoform
Slide 9: Financials
Nanoform Breaker Slide Financials Option 2 CFO Albert Hæggström 9 Nanoform.com | @nanoform
Slide 10: Nr of projects signed – rolling 12 months at new record
Nr of projects signed – rolling 12 months at new record 10
Slide 11: Revenue +46% y/y in 1Q25 at the same time as other income also grew
Revenue +46% y/y in 1Q25 at the same time as other income also grew 11
Slide 12: Improvement in cash flow to continue
Improvement in cash flow to continue At the end of 1Q25, Nanoform had more than EUR 37m in cash & short-term government bonds and no debt 12
Slide 13: Dealmaking update on leading Product Kernels
Dealmaking update on leading Product Kernels NANOENZALUTAMIDE* NANOAPALUTAMIDE** Germany Term sheet agreed France Term sheet agreed EU Term sheet negotiations ongoing Japan Term sheet agreed US Term sheet negotiations ongoing US Term sheet agreed Global Term sheet negotiations ongoing Spain Term she
Slide 14: Nanoform near-term business targets 2025 – all on track
Nanoform near-term business targets 2025 – all on track I To sign several license/commercial supply agreements on several product kernels during 2025 II First pivotal bioequivalence clinical study with a nanoformed medicine III Increased number of non-GMP and GMP projects signed in 2025 vs 2024 IV I
Slide 15: Commercial
Commercial Nanoform Breaker Slide CCO Christian Jones Option& 2 CDO Peter Hänninen 15 Nanoform.com | @nanoform
Slide 16: Nanoform commercial highlights
Nanoform commercial highlights Global pharma industry feedback - Nanoform's small/single pill strategy can enable significant I commercial value II Strong large pharma interest in Nanoform's high drug load subcutaneous biologics platform III Continued growth in signed customers and projects IV New U
Slide 17: Cumulative number of customers and customer projects signed
Cumulative number of customers and customer projects signed X new in Q1 and X X new YTD X new 4 new in Q1 YTDin Q1 3 new YTD and 11 YTD and 4 YTD Customers Customer Projects 107 56 96 52 42 71 33 48 21 30 8 12 3 2 2019 2020 2021 2022 2023 2024 2025 2019 2020 2021 2022 2023 2024 2025 YTD YTD 17 Nanof
Slide 18: Commercial Relationships 2019 - Q1 2025
Commercial Relationships 2019 - Q1 2025 Customer mix Selection of partners Takeda 12 41 major mid-sized, pharma specialty pharma & biotech companies 18 Nanoform.com | @nanoform
Slide 19: Nanoform Product Kernel overview
Nanoform Product Kernel overview* Nanoform at Nanoform Product Kernels Nanoform Pre-Clinical (non-GMP) Nanoform Clinical (GMP) Market Expected Nanoform Development Targeted Pre- Dosage form PoP* / Targeted Delivery route / Phase 1 / Pilot Pivotal - final - Originator Indication originator Nanoformed
Slide 20: Small molecules – Nanoform enables small/single pill strategy
Small molecules – Nanoform enables small/single pill strategy Existing drug Nanoformed version Nanoenzalutamide 40mg x 4 XTANDI® Nanoenzalutamide Formulation ASD Crystalline Nanoparticle XTANDI® Drug load 160mg (x1) - 40 % 40mg x 4 Drug load 40mg (x4) 12 % 40 % Nanoenzalutamide Size 160mg (x1) - 18.
Slide 21: Biologics - Game changing high drug load subcutaneous delivery
Biologics - Game changing high drug load subcutaneous delivery (400-500 mg/ml) High drug load Nanoformed high drug load monoclonal antibody Nanoformed monoclonal antibody in dry powder suspension in a prefilled in non-aqueous suspension syringe (400-500mg/ml) Nanoforming enables IV to SubQ switches
Slide 22: Q&A
Q&A Nanoform Breaker Slide Q & A2 Option www.nanoform.com Nanoform headquarters in Helsinki, Finland San Diego - New York - Lisbon - Oxford – London - Cambridge - Bordeaux - Stockholm – Budapest - Helsinki www.nanoform.com San Diego - Chicago - New York - Lisbon - Manchester - Oxford - London - Camb
Slide 23: Appendix
APPENDIX 23 Nanoform.com | @nanoform
Slide 24: Selection of upcoming events
Selection of upcoming events May 20-22 CPHI North America, Philadelphia June 2-4 16th Global DDF, Berlin June 4-5 DCAT Summit, Lugano June 12 Danske Bank Healthcare Seminar, Helsinki June 16-19 BIO International, Boston August 21 Nanoform Q2 2025 report September 15-16 DDF American Summit, Boston Se
Slide 25: Interesting short videos
Interesting short videos: Nanoform high dose subcutaneous delivery of biologics: https://nanoform.com/en/nanoform-high-dose-subcutaneous-delivery-of-biologics/ Discover how Nanoformed API outperform traditional solid dispersions: https://nanoform.com/en/nanoform-cphi-milan-2024-tamas-solymosi/ Nanof
Slide 26: 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 Non-GMP GMP ➢ Attrition between previous and current phase ➢ Price per phase per API ➢ # of active customers Phase I, ➢ Time lag betw
Slide 27: Nanoform Product Kernels
Nanoform Product Kernels Nanoform internal Development partners Commercial partners Product Kernel work Originator Originator 1. Value proposition around a medicine or or candidate, called ‘Product Kernel’ Supergeneric / High value medicine Supergeneric / High value medicine company company 1. Upfro
Slide 28: Attractive revenue model with pharma and biotech customers
Attractive revenue model with pharma and biotech customers Proof of Concept / Phase Phase I – III clinical trials Drugs on the market Proof of Process Certification Non-GMP GMP GMP • Proof of concept study - assessment of • API for clinical trials are manufactured in • Drugs that have passed the tri
Slide 29: The structural pharma R&D problem in the pharma industry
The structural pharma R&D problem in the pharma industry Fewer than 50 drugs approved in the US annually on average… …while the global pharma industry R&D expenditure exceeds $300B Annual number of novel drug approvals by FDA 2010-2024 Global pharmaceutical R&D spending 2014-2030E (USDbn) Chemical B
Slide 30: 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 31: 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 improved bioavailability of a drug • The surface area increases 30-fold from a 10 micron1 sized p
Slide 32: Small molecules - Small is powerful
Small molecules - Small is powerful® 32 Nanoform.com | @nanoform
Slide 33: Nanoform is here to fill the gap
Nanoform is here to fill the gap Giving Enabling Improving unsuccessful new drugs existing drug candidates a drugs second chance > 20,000 drugs in > 5,800 > 58,000 failed development* existing drugs* drugs in the last 40 years* 33 *Source: Nanoform and Pharmaprojects® | Informa, 2022 Nanoform.com |
Slide 34: 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 Nanoformed Revenue • Global large pharma API* • Fixed fee per project • Mid-sized and specialty pharma • Royalty as a
Slide 35: Growth from IPO 2020 to May 2025
Growth from IPO 2020 to May 2025 IPO June 2020 May 2025 Growth Employees 50 179 ~3x Manufacturing lines 5 20 ~4x Customers enrolled 5 56 ~11x Customer projects started 5 107 ~21x Patents granted 5 30 6x 35 Nanoform.com | @nanoform
Slide 36: Nanoform customer projects – therapy area overview
Nanoform customer projects – therapy area overview* Pre-Clinical Phase I Phase II & III Marketed/505b2 Cardiology Immunology/Inflammation Metabolism and Endocrinology Infectious Disease (e.g. Anemia) (e.g. Cystic Fibrosis) (e.g. Adrenal Hyperplasia) (e.g. HIV) Gastroenterology Dermatology/Oncology N
Slide 37: Substantial progress in Nanoforming solutions with in-vitro, in-vivo, and clinical results
Nanoform has made substantial progress in Nanoforming solutions with in-vitro, in-vivo, and clinical study results Oncology: Replaced amorphous solid dispersion (ASD) formulations with nanocrystalline high drug load formulations, matching bioequivalence for Enzalutamide and Apalutamide where life cy
Slide 38: Small Molecules - Proprietary technology
Small Molecules - Proprietary technology Green technology Controlled Expansion of Supercritical Solutions - CESS® Contro lled ➢ Relatively simple process developed through combining deep knowledge in physics, chemistry, and pharma 38 The CESS® technology platform was described in detail in the IPO p
Slide 39: CESS Superior to Existing Technologies
CESS® Superior to Existing Technologies Controlled Expansion of Solid dispersion Supercritical Solutions Jet milling Nanomilling (e.g. spray drying) (CESS®) Extracts API from API is dispersed into a solid Application of energy to supercritical CO2 by applying material, which dissolves API particle s
Slide 40: Large molecules - Proprietary technology
Large molecules - Proprietary technology Green technology Nanoforming process for biologics API = active pharmaceutical ingredient 40 Nebulization = turns liquid into mist Nanoform.com | @nanoform Ionization = particles electrically charged
Slide 41: Comparison of Nanoform’s biologics technology vs existing technologies
Comparison of Nanoform’s proprietary biologics technology vs existing technologies Nanoformed Spray dried Lyophilized / freeze dried Perfect spheres, highly flowable and aerodynamic, Sticky, poor flowability, raisin shaped Flaky morphology, dry cake, no flowability great packing and injection proper
Slide 42: Business case Amorphous Solid Dispersions (ASDs)
Business case Amorphous Solid Dispersions (ASDs) Amorphous solid dispersion (ASD) medicines are currently the leading formulation strategy for poorly soluble APIs and there are ~50 marketed medicines globally that are ASDs and sell for ~$50bln annually Nanoformed and nanocrystalline medicines (e.g.
Slide 43: Nanoenzalutamide clinical trials
Nanoenzalutamide clinical trials 2023-2024 2025 Phase 1/Pilot clinical trial in North America. Pivotal bioequivalence clinical trials in EU and US are expected to start in Q2 2025, with first read-outs in the summer of 2025. Relative bioavailability study of nanocrystalline-enabled enzalutamide (nan
Slide 44: Project Nanoenzalutamide (oral tablet for prostate cancer)
Project Nanoenzalutamide (oral tablet for prostate cancer) Clinical results 26.1.2024: Very promising relative bioavailability study of nanocrystalline-enabled enzalutamide* (nanoenzalutamide) tablet formulation. Nanoforming benefits: 1) Opportunity for an improved and differentiated finished produc
Slide 45: Project Nanoapalutamide (oral tablet for prostate cancer)
Project Nanoapalutamide (oral tablet for prostate cancer) FEBRUARY 19, 2024 – APALUTAMIDE STUDY AGAIN DEMONSTRATES THE ADVANTAGES OF NANOFORMING OVER TRADITIONAL CANCER TREATMENT FORMULATIONS Positive results from own pre-clinical, in-vivo study of a nanocrystalline-enabled apalutamide oral formulat
Slide 46: Takeda (plasma-derived formulations for rare conditions)
Takeda (plasma-derived formulations for rare conditions) MAY 7, 2024 - NANOFORMED HIGH-CONCENTARION BIOLOGICS FORMULATION FOR SUBCUTANEOUS DELIVERY RESULTS TO BE PRESENTED BY TAKEDA AD DDF SUMMIT The proof-of-concept study data support the potential of Nanoform’s patented biologics platform to achie
Slide 47: Project Glioblastoma (hydrogel for central nervous system cancer)
Project Glioblastoma (hydrogel for central nervous system cancer) Nanoform customer TargTex S.A. was granted Orphan Drug Designation by FDA for its nanoformed drug candidate TTX101 to be used in patients with malignant gliomas (October 2023). The orphan drug designation follows the generation of a p
Slide 48: Experienced global sales team driving commercialization
Experienced global sales team driving commercialization – Locations and previous experiences Manchester Oxford London Cambridge Helsinki Brussels Chicago Cologne Budapest New York Japan (CBC) San Diego Bordeaux Lisbon 48 Nanoform.com | @nanoform
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. (Economics) Edward Hæggström • Professor at the University of Helsinki, Head of Electronics Research Lab. Albert Hæggström • 20 years of finance and investi
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 position
Slide 51: Thank you
Thank you FURTHER ENQUIRIES CEO Edward Hæggström - edward.haeggstrom@nanoform.com, +358 50 317 54 93 CFO Albert Hæggström - albert.haeggstrom@nanoform.com, +358 40 161 4191 DIR Henri von Haartman - hvh@nanoform.com, +46 76866 50 11 Nanoform.com | @nanoform