Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — Q1 2024 Earnings Presentation
45 slides from Nanoform Finland Oyj's earnings presentation, May 30, 2024
Slide 1: Nanoform Management Presentation Q1 2024 Interim Report
Nanoform Management Presentation Q1 2024 Interim Report May 30th, 2024
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: Nanoform introduction
Nanoform Breaker Slide Nanoform introduction Option 2 CEO Edward Hæggström 3 Nanoform.com | @nanoform
Slide 4: The structural pharma R&D problem
The structural pharma R&D problem Fewer 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 2010-2023 Global pharmaceutical R&D spending 2014-2028E (USDbn) Chemical Biologics 300 60 278 285
Slide 5: 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 6: 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 7: Small molecules - Small is powerful
Small molecules - Small is powerful® 7 Nanoform.com | @nanoform
Slide 8: Proprietary technology platforms
Proprietary technology platforms Small Large Formulation AI molecules molecules CESS®* technology Our unique biologic Full therapeutic STARMAP® online is enables new nanoparticles enable potential is unlocked the digital twin of our medicines through improved with nano-formulated CESS® process. It i
Slide 9: 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* 9 *Source: Nanoform and Pharmaprojects® | Informa, 2022 Nanoform.com | @
Slide 10: 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 API* • Royalty as a % based
Slide 11: Nanoform - What and How
Nanoform - What and How Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP nano-API manufacturing to enable superior medicines for patients. Nanoform focuses on reducing clinical a
Slide 12: Nanoform Strategy – Key Points
Nanoform Strategy – Key Points • All APIs should be Starmapped – it is the smart, cost/time-efficient and green way. • Nanoform work with customers to enable both novel and existing molecules to become new and improved medicines. We provide unique formulated nano-drug-products for small molecules an
Slide 13: STARMAP predicts nanoforming is an attractive alternative to ASDs
STARMAP® predicts that nanoforming is an attractive alternative to ASDs Amorphous solid dispersions (n=46 APIs) ✓ STARMAP predicts that 78% of marketed ASD APIs fall 5 within our processing “sweet spot" Propensity to crystallise in CESS ✓ 46 ASDs have been Starmapped 4 ✓ There are ~50 ASDs on the ma
Slide 14: Within marketed ASDs 31/39 passed our STARMAP screen
Within marketed ASDs 31/39 passed our STARMAP® screen and are predicted to be amenable to nanoforming* Belsomra® suvorexant Pifeltro® doravirine Braftovi® encorafenib Prezista® darunavir Cesamet® nabilone Prograf® tacrolimus Deltyba® delamanid Qinlock® ripretinib Erleada® apalutamide Sotyktu® deucra
Slide 15: ASD Products Partner Programs
From the list of 31 products, we have identified 7 product kernels where we see great potential to show the industry the power of nanoforming Technical, financial and IP analysis Partnering discussions: ✓ Commercial terms ✓ Fit to strategy/pipeline * 31 ✓ Timelines 7 ASD Products Partner Programs ✓
Slide 16: Nanoform highlights 2024 YTD
Nanoform highlights 2024 YTD May Nanoformed High-Concentration Biologics Formulation for Subcutaneous Delivery Results Presented by Takeda at DDF Summit in Berlin April Nanoform successfully completes new share issue raising EUR 15.4 million to invest in commercialization of nanoparticle enabled for
Slide 17: Nanoform near-term business targets 2024
Nanoform near-term business targets 2024 Topic Target Status Bulk Increased number of non-GMP API and GMP Customer Projects On track projects signed in 2024 vs 2023 * Improved operating Operating free cashflow On track Free Cashflow in 2024 vs 2023 ** Nanoformed API To sign one or several license/co
Slide 18: Financials
Nanoform Breaker Slide Financials Option 2 CFO Albert Hæggström 18 Nanoform.com | @nanoform
Slide 19: Nr of employees & nr of lines
Nr of employees & nr of lines GMP lines 2&3 will be commissioned after approval by Fimea, inspection date set to June 11-12, 2024. 19
Slide 20: Nr of proposals sent and projects signed
Nr of proposals sent and projects signed
Slide 21: Nr of projects signed and nr of projects generating revenue
Nr of projects signed and nr of projects generating revenue
Slide 22: Quarterly and rolling 12 months revenue
Quarterly and rolling 12 months revenue* *Impact on revenue can in a quarter(s) for some of the projects be negative if budgeted costs increase significantly (often related to hours worked). 22
Slide 23: Quarterly gross margin improvement
Quarterly gross margin improvement Excluding the cost of external GMP QC services, related to the nanoenzalutamide project, our underlying gross margin has remained above 90%. In June 2023, Nanoform submitted a notification to the Finnish Medicines Agency to update our Manufacturer’s Authorization.
Slide 24: Improvement in operating free cash flow continues
Improvement in operating free cash flow continues After the share issue April 24 Nanoform had ~EUR55m (~SEK640m) in cash & short-term government bonds (no debt)
Slide 25: Commercial
Nanoform Breaker Slide Commercial Option 2 CCO Christian Jones 25 Nanoform.com | @nanoform
Slide 26: 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 27: Commercial Relationships 2019 - Q1 2024
Commercial Relationships 2019 - Q1 2024 Customer mix Selection of partners 10 major Takeda 31 mid-sized, pharma specialty pharma & biotech companies 1 co-development 3 collaborations 27 Nanoform.com | @nanoform
Slide 28: 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 29: Expanding our market reach to Japan
Expanding our market reach to Japan Nanoform.com | @nanoform
Slide 30: Comparison of Nanoform bio platform vs the rest
Comparison of Nanoform bio platform vs the rest - A picture tells a thousand words 30 Nanoform.com | @nanoform
Slide 31: Takeda showcases Nanoform technology for high concentration biologics
Takeda showcases Nanoform technology for high concentration biologics 31 Nanoform.com | @nanoform
Slide 32: Celanese showcases Nanoform technology for long acting drug release
Celanese showcases Nanoform technology for long acting drug release 32 Nanoform.com | @nanoform
Slide 33: Upcoming events
Upcoming events May 31-June 4 ASCO Annual Meeting, Chicago June 3-6 Bio International 2024, San Diego June 5 Handelsbanken Small & Mid Cap Seminar, Stockholm June 13 Danske Bank Healthcare Seminar, Helsinki June 26-28 Interphex -Japan, Tokyo August 29 Nanoform Half-year Financial Report January-June
Slide 34: Q & A
Nanoform Breaker Slide Q & A2 Option www.nanoform.com San Diego - New York - Lisbon - Oxford – London - Cambridge - Bordeaux - Stockholm – Budapest - Helsinki 34 Nanoform.com | @nanoform
Slide 35: Appendix
APPENDIX 35 Nanoform.com | @nanoform
Slide 36: Important milestone with promising clinical results for nanoenzalutamide
Important milestone with very promising clinical results for patient- centric nanotechnology-enhanced Enzalutamide – Jan 26th, 2024 Clinical trial: Very promising relative bioavailability study of nanocrystalline-enabled enzalutamide (nanoenzalutamide) tablet formulation Nanoforming benefits: ▪ Oppo
Slide 37: 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 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: 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: 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 40 The CESS® technology platform was described in detail in the IPO p
Slide 41: Large molecules - Proprietary technology
Large molecules - Proprietary technology Green technology Nanoforming process for biologics API = active pharmaceutical ingredient 41 Nebulization = turns liquid into mist Nanoform.com | @nanoform Ionization = particles electrically charged
Slide 42: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders 42 1) Latest ownerhsip data can be found at https://nanoform.com/en/ownership-structure/ Nanoform.com | @nanoform
Slide 43: Management team
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 44: Board of directors
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 45: Thank you
Thank you FURTHER ENQUIRIES CEO Edward Hæggström - edward.haeggstrom@nanoform.com, +358 29 370 0150 CFO Albert Hæggström - albert.haeggstrom@nanoform.com, +358 29 370 0150 DIR Henri von Haartman - hvh@nanoform.com, +46 76866 50 11 Nanoform.com | @nanoform