Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — FY2024 Earnings Presentation
56 slides from Nanoform Finland Oyj's earnings presentation, Feb 27, 2025
Slide 1: Nanoform Management Presentation Q4 and FY2024 report
Nanoform Management Presentation Q4 and FY2024 report February 27th, 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 2024 showed a record number of new customer projects signed. The dealmaking discussions around our product kernels intensified, we expect to sign deals on our first three II product kernels in the coming weeks and months (Nanoenzalutamide, Nanoapalutamide, Nanoenco
Slide 8: Nanoenzalutamide batches shipped for tableting
Nanoenzalutamide batches shipped for tableting 8 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 – strong 2H24 led to record 2024
Nr of projects signed – strong 2H24 led to record 2024 10 Nanoform.com | @nanoform
Slide 11: Another record year both in proposals sent and signed
Another record year both in proposals sent and signed 11 Nanoform.com | @nanoform
Slide 12: Revenue +87% y/y in 4Q, +8% in 2024
Revenue +87% y/y in 4Q, +8% in 2024 12 Nanoform.com | @nanoform
Slide 13: Project amount growth strong in 2H, revenue expected to follow
Project amount growth strong in 2H, revenue expected to follow 13 Nanoform.com | @nanoform
Slide 14: Operating free cash flow
Operating free cash flow (EURm) Operating free cash flow (EURm) Operating free cash flow 0,0 0,0 -5,0 -2,0 -10,0 - 8,7 -4,0 - 4,0 - 4,5 -15,0 - 4,8 - 4,9 - 5,0 - 5,2 -6,0 - 5,7 - 6,0 - 5,9 - 6,2 - 6,2 - 6,1 - 6,0 - 5,9 -20,0 - 6,4 - 20,5 - 6,9 - 6,9 - 6,8 - 22,6 -8,0 -25,0 - 23,1 - 8,2 - 8,1 - 25,5
Slide 15: Nanoform near-term business targets 2024
Nanoform near-term business targets 2024 Topic Target Outcome Bulk 25 in 2024 (24 non-GMP and 1 GMP) Increased number of non-GMP and GMP projects Customer Projects API vs signed in 2024 vs 2023 23 in 2023 (22 non-GMP and 1 GMP) EUR -22.6m 2024 Operating Improved operating free cashflow vs Free Cashf
Slide 16: Nanoform near-term business targets 2025
Nanoform near-term business targets 2025 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 Improved free ca
Slide 17: Nanoform mid-term business targets 2030
Nanoform mid-term business targets 2030 To be announced during 2025 in conjunction with Capital Markets Day 17 Nanoform.com | @nanoform
Slide 18: Commercial
Commercial Nanoform Breaker Slide CCO Christian Jones Option& 2 CDO Peter Hänninen 18 Nanoform.com | @nanoform
Slide 19: Nanoform commercial highlights 2024
Nanoform commercial highlights 2024 ✓ New annual record in customer project intake ✓ 10 new customers including 1 new major pharma, now 11 out of top 20 pharma ✓ Record number of customers returning with new projects ✓ Significant traction with originators on Nanoform’s Product Kernels ✓ Strong inte
Slide 20: 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 21: Nanoform Product Kernel overview
Nanoform Product Kernel overview* Nanoform at Nanoform Product Kernels Nanoform Pre-Clinical (non-GMP) Nanoform Clinical (GMP) Market (GMP) Expected Nanoform Development Targeted Pre- Dosage form PoP* / Delivery route / Pivotal (final Targeted market Originator Indication originator Nanoformed API o
Slide 22: Leading Product Kernels
Leading Product Kernels 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) - 18.1 x 8.6 mm 160mg x 1 Size 40mg (x4) 10
Slide 23: 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 23 Nanoform.com | @nanoform
Slide 24: Cumulative number of customers and customer projects signed
Cumulative number of customers and customer projects signed Customers 3 new Customer Projects 8 new in Q4 in Q4 96 52 42 71 33 48 21 30 8 12 3 2 2019 2020 2021 2022 2023 2024 2019 2020 2021 2022 2023 2024 24 Nanoform.com | @nanoform
Slide 25: Commercial Relationships 2019-2024
Commercial Relationships 2019-2024 Customer mix Selection of partners 11 major Takeda pharma 39 mid-sized, specialty pharma 2 co- & biotech developments companies 3 collaborations 25 Nanoform.com | @nanoform
Slide 26: Leading world congresses and customer factory tours at HQ in Helsinki
Leading world congresses and customer factory tours at HQ in Helsinki PolPharma visiting Nanoform headquarters in Helsinki, just 15min from the airport. Head of Manufacturing Dr David Rowe showing Nanoform GMP manufacturing capabilities. Further to the right the guests and hosts at Nanoform’s liquid
Slide 27: Selection of upcoming events
Selection of upcoming events March 11 Danske Bank Small & Mid Cap Seminar, Stockholm March 12-13 Swiss Nordic BIO, Zürich March 16-20 DCAT, New York March 17-19 BIO-Europe Spring, Milan March 26-27 DNB/Back Bay Nordic-American Healthcare Conference, New York March 26-29 The 145th Annual Meeting of t
Slide 28: 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 29: Appendix
APPENDIX 29 Nanoform.com | @nanoform
Slide 30: 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 31: 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 32: 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 33: 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 34: Small molecules - Small is powerful
Small molecules - Small is powerful® 34 Nanoform.com | @nanoform
Slide 35: 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* 35 *Source: Nanoform and Pharmaprojects® | Informa, 2022 Nanoform.com |
Slide 36: 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 37: Growth from IPO 2020 to December 2024
Growth from IPO 2020 to December 2024 IPO June 2020 December 2024 Growth Employees 50 181 ~3x Manufacturing lines 5 20 ~4x Customers enrolled 5 52 ~10x Customer projects started 5 96 ~19x Patents granted 5 42 ~8x 37 Nanoform.com | @nanoform
Slide 38: 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 39: 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 40: 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 41: Customer projects and customer's formulation challenge
Customer projects and customer’s formulation challenge* Pre- Company Type Therapeutic Area Customer Formulation Challenge Phase 1 Phase 2 Phase 3 Marketed Clinical Mid-Size Pharma/Biotech Oncology Drug Load Mid-Size Pharma/Biotech Oncology Drug Load Mid-Size Pharma/Biotech Autoimmune Food Effect/Dos
Slide 42: 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 43: 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 43 The CESS® technology platform was described in detail in the IPO p
Slide 44: 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 45: Large molecules - Proprietary technology
Large molecules - Proprietary technology Green technology Nanoforming process for biologics API = active pharmaceutical ingredient 45 Nebulization = turns liquid into mist Nanoform.com | @nanoform Ionization = particles electrically charged
Slide 46: 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 47: 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 48: 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 Q2 2025. Relative bioavailability study of nanocrystalline-enabled enzalutamide (nanoenzalutami
Slide 49: 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 50: 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 51: 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 52: 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 53: 4 cases
4 cases Nanoenzalutamide Nanoapalutamide TargTex Takeda Product Kernel Product Kernel Biotech customer Major pharma customer Prostate Cancer Prostate Cancer Glioblastoma Multiforme Rare diseases Large molecule (Plasma Derived Small molecule Small molecule Small molecule Therapy) Reformulated existin
Slide 54: 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 55: 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 56: 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